Components:
Oxytocin
Oxytocin
Method of action:
Pituitary And Hypothalamic Hormones And Analogues, Stimulating Generic Activity, Uterotonizing
Pituitary And Hypothalamic Hormones And Analogues, Stimulating Generic Activity, Uterotonizing
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Name of the medicinal product

A.A. Oxytocine

Qualitative and quantitative composition

Oxytocin

Therapeutic indications

The information provided in Therapeutic indications of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

Antepartum

• Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia)

• Stimulation of labour in hypotonic uterine inertia

• Early stages of pregnancy as adjunctive therapy for the management of incomplete, inevitable, or missed abortion

Postpartum

• During caesarean section, but following delivery of the child

• Prevention and treatment of postpartum uterine atony and haemorrhage

Antepartum

• Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia)

• Stimulation of labour in hypotonic uterine inertia

• Early stages of pregnancy as adjunctive therapy for the management of incomplete, inevitable, or missed abortion.

Postpartum

• During caesarean section, but following delivery of the child

• Prevention and treatment of postpartum uterine atony and haemorrhage

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

Induction or enhancement of labour: A.A. Oxytocine should not be started for 6 hours following administration of vaginal prostaglandins.). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to A.A. Oxytocine, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by IV infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by IV infusion of a solution containing 5 to 20 IU of A.A. Oxytocine in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

Induction or enhancement of labour: Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins.“Special warnings and precautions for use”). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

Contraindications

The information provided in Contraindications of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet
<

• Hypertonic uterine contractions, mechanical obstruction to delivery, foetal distress.

Any condition in which, for foetal or maternal reasons, spontaneous labour is inadvisable and/or vaginal delivery is contra-indicated: e.g.:

• Significant cephalopelvic disproportion

• Foetal malpresentation

• Placenta praevia and vasa praevia

• Placental abruption

• Cord presentation or prolapse

• Overdistension or impaired resistance of the uterus to rupture as in multiple pregnancy

• Polyhydramnios

• Grand multiparity

• In the presence of a uterine scar resulting from major surgery including classical caesarean section.

A.A. Oxytocine should not be used for prolonged periods in patients with A.A. Oxytocine-resistant uterine inertia, severe pre-eclamptic toxaemia or severe cardiovascular disorders.

<).

<

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
more... close
Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

A.A. Oxytocine must only be administered as an IV infusion and never by IV bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.

Induction of labour

The induction of labour by means of A.A. Oxytocine should be attempted only when strictly indicated for medical reasons. Administration should only be under hospital conditions and qualified medical supervision.

Cardiovascular disorders

A.A. Oxytocine should be used with caution in patients who have a pre-disposition to myocardial ischaemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischaemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure and heart rate in these patients.

QT Syndrome

<).

When A.A. Oxytocine is given for induction and enhancement of labour:

• Foetal distress and foetal death: Administration of A.A. Oxytocine at excessive doses results in uterine overstimulation which may cause foetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or rupture of the uterus.

Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and duration of contractions) is essential, so that the dosage may be adjusted to individual response.

• Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension or cardiac disease, and in patients above 35 years of age or with a history of lower-uterine-segment caesarean section.

• Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labour using uterotonic agents, including A.A. Oxytocine increases the risk of postpartum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years of age or over, complications during pregnancy and gestational age more than 40 weeks. In these women, A.A. Oxytocine or any other alternative drug should be used with care, and the practitioner should be alerted by signs of DIC.

Intrauterine death

In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labour must be avoided, as it may cause amniotic fluid embolism.

Water intoxication

Because A.A. Oxytocine possesses slight antidiuretic activity, its prolonged IV administration at high doses in conjunction with large volumes of fluid, as may be the case in the treatment of inevitable or missed abortion or in the management of postpartum haemorrhage, may cause water intoxication associated with hyponatraemia. The combined antidiuretic effect of A.A. Oxytocine and the IV fluid administration may cause fluid overload leading to a haemodynamic form of acute pulmonary oedema without hyponatraemia. To avoid these rare complications, the following precautions must be observed whenever high doses of A.A. Oxytocine are administered over a long time: an electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by infusing A.A. Oxytocine at a higher concentration than recommended for the induction or enhancement of labour at term); fluid intake by mouth must be restricted; a fluid balance chart should be kept, and serum electrolytes should be measured when electrolyte imbalance is suspected.

Renal Impairment

Caution should be exercised in patients with severe renal impairment because of possible water retention and possible accumulation of A.A. Oxytocine .

”). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

4.3 Contraindications <4.4 Special warnings and precautions for use

A.A. Oxytocine must only be administered as an i.v. infusion and never by i.v. bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.

Induction of labour

The induction of labour by means of oxytocin should be attempted only when strictly indicated for medical reasons. Administration should only be under hospital conditions and qualified medical supervision.

Cardiovascular disorders

A.A. Oxytocine should be used with caution in patients who have a pre-disposition to myocardial ischaemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischaemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure and heart rate in these patients.

QT syndrome

<).

When A.A. Oxytocine is given for induction and enhancement of labour:

• Foetal distress and foetal death: Administration of oxytocin at excessive doses results in uterine overstimulation which may cause foetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or rupture of the uterus. Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and duration of contractions) is essential, so that the dosage may be adjusted to individual response.

• Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension or cardiac disease, and in patients above 35 years of age or with a history of lower-uterine-segment caesarean section.

• Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labour using uterotonic agents, including oxytocin increases the risk of post partum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years of age or over, complications during pregnancy and gestational age more than 40 weeks. In these women, oxytocin or any other alternative drug should be used with care, and the practitioner should be alerted by signs of DIC.

Intrauterine death

In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labour must be avoided, as it may cause amniotic fluid embolism.

Water intoxication

Because oxytocin possesses slight antidiuretic activity, its prolonged i.v. administration at high doses in conjunction with large volumes of fluid, as may be the case in the treatment of inevitable or missed abortion or in the management of postpartum haemorrhage, may cause water intoxication associated with hyponatraemia. The combined antidiuretic effect of oxytocin and the i.v. fluid administration may cause fluid overload leading to a haemodynamic form of acute pulmonary oedema without hyponatraemia. To avoid these rare complications, the following precautions must be observed whenever high doses of oxytocin are administered over a long time: an electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by infusing oxytocin at a higher concentration than recommended for the induction or enhancement of labour at term); fluid intake by mouth must be restricted; a fluid balance chart should be kept, and serum electrolytes should be measured when electrolyte imbalance is suspected.

Renal Impairement

Caution should be exercised in patients with severe renal impairment because of possible water retention and possible accumulation of oxytocin .

Anaphylaxis in women with latex allergy

There have been reports of anaphylaxis following administration of oxytocin in women with a known latex allergy. Due to the existing structural homology between oxytocin and latex, latex allergy/intolerance may be an important predisposing risk factor for anaphylaxis following oxytocin administration.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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A.A. Oxytocine can induce labour, therefore caution should be exercised when driving or operating machines. Women with uterine contractions should not drive or use machines.

Undesirable effects

The information provided in Undesirable effects of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

As there is a wide variation in uterine sensitivity, uterine spasm may be caused in some instances by what are normally considered to be low doses. When A.A. Oxytocine is used by IV infusion for the induction or enhancement of labour, administration at too high doses results in uterine overstimulation which may cause foetal distress, asphyxia, and death, or may lead to hypertonicity, tetanic contractions, soft tissue damage or rupture of the uterus.

<). These rapid haemodynamic changes may result in myocardial ischaemia, particularly in patients with pre-existing cardiovascular disease. Rapid IV bolus injection of A.A. Oxytocine at doses amounting to several IU may also lead to QTc prolongation.

<).

Water intoxication

<). Special warnings and precautions for use).

Symptoms of water intoxication include:

1. Headache, anorexia, nausea, vomiting and abdominal pain.

2. Lethargy, drowsiness, unconsciousness and grand-mal type seizures.

3. Low blood electrolyte concentration.

Undesirable effects (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports; not known (cannot be estimated from the available data). The ADRs tabulated below are based on clinical trial results as well as postmarketing reports.

The adverse drug reactions derived from post-marketing experience with A.A. Oxytocine are via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Table 1 Adverse drug reactions in mother

System organ class

Adverse drug reaction

Immune system disorders

Rare: Anaphylactic/Anaphylactoid reaction associated with dyspnoea, hypotension or Anaphylactic/Anaphylactoid Shock

Nervous system disorders

Common: Headache

Cardiac disorders

Common: Tachycardia, bradycardia

Uncommon: Arrhythmia

Not known: Myocardial ischaemia, Electrocardiogram QTc prolongation

Vascular disorders

Not known: Hypotension, haemorrhage

Gastrointestinal disorders

Common: Nausea, vomiting

Skin and subcutaneous tissue disorders

Rare: Rash

Pregnancy, puerperium and perinatal conditions

Not known: Uterine hypertonus, tetanic contractions of uterus, rupture of the uterus

Metabolism and nutrition disorders

Not known: Water intoxication, maternal hyponatraemia

Respiratory, thoracic and mediastinal disorders

Not known: acute pulmonary oedema

General disorders and administration site conditions

Not known: Flushing

Blood and lymphatic system disorders

Not known: disseminated intravascular coagulation

Skin and subcutaneous tissue disorders

Not Known: Angioedema

Table 2 Adverse drug reactions in foetus/neonate

System organ class

Adverse drug reaction

Pregnancy, puerperium and perinatal conditions

Not known: foetal distress, asphyxia and death

Metabolism and nutrition disorders

Not known: Neonatal hyponatraemia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

<).).

Water intoxication

<“Special warnings and precautions for use”). Special warnings and precautions for use).

Symptoms of water intoxication include:

1. Headache, anorexia, nausea, vomiting and abdominal pain.

2. Lethargy, drowsiness, unconsciousness and grand-mal type seizures.

3. Low blood electrolyte concentration.

Undesirable effects (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports; not known (cannot be estimated from the available data).The ADRs tabulated below are based on clinical trial results as well as postmarketing reports.

The adverse drug reactions derived from post-marketing experience with A.A. Oxytocine are via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Table 1 Adverse drug reactions in mother

System organ class

Adverse drug reaction

Immune system disorders

Rare: Anaphylactic/Anaphylactoid reaction associated with dyspnoea, hypotension or Anaphylactic/Anaphylactoid shock

Nervous system disorders

Common: Headache

Cardiac disorders

Common Tachycardia, bradycardia

Uncommon: Arrhythmia

Not known: Myocardial ischaemia, Electrocardiogram QTc prolongation

Vascular disorders

Not known: Hypotension, haemorrhage

Gastrointestinal disorders

Common: Nausea, vomiting

Skin and subcutaneous tissue disorders

Rare: Rash

Pregnancy, puerperium and perinatal conditions

Not known: Uterine hypertonus, tetanic contractions of uterus, rupture of the uterus

Metabolism and nutrition disorders

Not known: Water intoxication, maternal hyponatraemia

Respiratory, thoracic and mediastinal disorders

Not known: acute pulmonary oedema

General disorders and administration site conditions

Not known: Flushing

Blood and lymphatic system disorders

Not known: disseminated intravascular coagulation

Skin and subcutaneous tissue disorders

Not Known: Angioedema

Table 2 Adverse drug reactions in foetus/neonate

System organ class

Adverse drug reaction

Pregnancy, puerperium and perinatal conditions

Not known: foetal distress syndrome, asphyxia and death

Metabolism and nutrition disorders

Not known: Neonatal hyponatraemia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose

The information provided in Overdose of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

The fatal dose of A.A. Oxytocine has not been established. A.A. Oxytocine is subject to inactivation by proteolytic enzymes of the alimentary tract. Hence it is not absorbed from the intestine and is not likely to have toxic effects when ingested.

<8 Undesirable effects. In addition, as a result of uterine overstimulation, placental abruption and/or amniotic fluid embolism have been reported.

Treatment: When signs or symptoms of overdosage occur during continuous IV administration of A.A. Oxytocine, the infusion must be discontinued at once and oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur. In the case of coma, a free airway should be maintained with routine measures normally employed in the nursing of the unconscious patient.

<“Special warnings and precautions for use” and 4.8 “Undesirable effects”. In addition, as a result of uterine overstimulation, placental abruption and/or amniotic fluid embolism have been reported.

Treatment: When signs or symptoms of overdosage occur during continuous i.v. administration of A.A. Oxytocine, the infusion must be discontinued at once and oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur. In the case of coma, a free airway should be maintained with routine measures normally employed in the nursing of the unconscious patient.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

Pharmacotherapeutic group: Posterior pituitary lobe hormones

ATC code: H01B B02

Mechanism of action

A.A. Oxytocine is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to suckling and labour.

A.A. Oxytocine stimulates the smooth muscle of the uterus, more powerfully towards the end of pregnancy, during labour, and immediately postpartum. At these times, the A.A. Oxytocine receptors in the myometrium are increased.

The A.A. Oxytocine receptors are G-proteins coupled receptors. Activation of receptor by A.A. Oxytocine triggers release of calcium from intracellular stores and thus leads to myometrial contraction.

A.A. Oxytocine elicits rhythmic contractions in upper segment of uterus, similar in frequency, force and duration to those observed during labour.

Being synthetic, A.A. Oxytocine in A.A. Oxytocine does not contain vasopressin, but even in its pure form A.A. Oxytocine possesses some weak intrinsic vasopressin-like antidiuretic activity.

Based on in vitro studies, prolonged exposure of A.A. Oxytocine had been reported to cause desensitisation of A.A. Oxytocine receptors probably due to down-regulation of A.A. Oxytocine-binding sites, destabilisation of A.A. Oxytocine receptors mRNA and internalisation of A.A. Oxytocine receptors.

Plasma levels and onset/duration of effect

Intravenous infusion. When A.A. Oxytocine is given by continuous IV infusion at doses appropriate for induction or enhancement of labour, the uterine response sets in gradually and usually reaches a steady state within 20 to 40 minutes. The corresponding plasma levels of A.A. Oxytocine are comparable to those measured during spontaneous first-stage labour. For example, A.A. Oxytocine plasma levels in 10 pregnant women at term receiving a 4 milliunits per minute intravenous infusion were 2 to 5 microunits/mL. Upon discontinuation of the infusion, or following a substantial reduction in the infusion rate, e.g. in the event of overstimulation, uterine activity declines rapidly but may continue at an adequate lower level.

Pharmacotherapeutic group: Posterior pituitary lobe hormones

ATC code: H01B B02

Mechanism of action

Oxytocin is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to suckling and labour.

Oxytocin stimulates the smooth muscle of the uterus, more powerfully towards the end of pregnancy, during labour, and immediately postpartum. At these times, the oxytocin receptors in the myometrium are increased.

The oxytocin receptors are G-proteins coupled receptors. Activation of receptor by oxytocin triggers release of calcium from intracellular stores and thus leads to myometrial contraction.

Oxytocin elicits rhythmic contractions in upper segment of uterus, similar in frequency, force and duration to those observed during labour.

Being synthetic, oxytocin in A.A. Oxytocine does not contain vasopressin, but even in its pure form oxytocin possesses some weak intrinsic vasopressin-like antidiuretic activity.

Based on in vitro studies, prolonged exposure of oxytocin had been reported to cause desensitisation of oxytocin receptors probably due to down-regulation of oxytocin-binding sites, destabilisation of oxytocin receptors mRNA and internalisation of oxytocin receptors.

Plasma levels and onset/duration of effect

Intravenous infusion. When A.A. Oxytocine is given by continuous i.v. infusion at doses appropriate for induction or enhancement of labour, the uterine response sets in gradually and usually reaches a steady state within 20 to 40 minutes. The corresponding plasma levels of oxytocin are comparable to those measured during spontaneous first-stage labour. For example, oxytocin plasma levels in 10 pregnant women at term receiving a 4 milliunits per minute intravenous infusion were 2 to 5 microunits/mL. Upon discontinuation of the infusion, or following a substantial reduction in the infusion rate, e.g. in the event of overstimulation, uterine activity declines rapidly but may continue at an adequate lower level.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Absorption

Plasma levels of A.A. Oxytocine following intravenous infusion at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/mL.

Distribution

The steady-state volume of distribution determined in 6 healthy men after IV injection is 12.2 L or 0.17 L/kg. Plasma protein binding is negligible for A.A. Oxytocine. It crosses the placenta in both directions. A.A. Oxytocine may be found in small quantities in mother's breast milk.

Biotransformation/Metabolism

A.A. Oxytocinease is a glycoprotein aminopeptidase that is produced during pregnancy and appears in the plasma. It is capable of degrading A.A. Oxytocine. It is produced from both the mother and the foetus. Liver and kidney plays a major role in metabolising and clearing A.A. Oxytocine from the plasma. Thus, liver, kidney and systemic circulation contribute to the biotransformation of A.A. Oxytocine.

Elimination

Plasma half-life of A.A. Oxytocine ranges from 3 to 20 min. The metabolites are excreted in urine whereas less than 1% of the A.A. Oxytocine is excreted unchanged in urine. The metabolic clearance rate amounts to 20 mL/kg/ min in the pregnant woman.

Renal impairment

No studies have been performed in renally impaired patients. However, considering the excretion of A.A. Oxytocine and its reduced urinary excretion because of anti-diuretic properties, the possible accumulation of A.A. Oxytocine can result in prolonged action.

Hepatic impairment

No studies have been performed in hepatically impaired patients. Pharmacokinetic alteration in patients with impaired hepatic function is unlikely since metabolising enzyme, A.A. Oxytocinease, is not confined to liver alone and the A.A. Oxytocinease levels in placenta during the term has significantly increased. Therefore, biotransformation of A.A. Oxytocine in impaired hepatic function may not result in substantial changes in metabolic clearance of A.A. Oxytocine.

Absorption

Plasma levels of oxytocin following intravenous infusion at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/mL.

Distribution

The steady-state volume of distribution determined in 6 healthy men after i.v. injection is 12.2 L or 0.17 L/kg. Plasma protein binding is negligible for oxytocin. It crosses the placenta in both directions. Oxytocin may be found in small quantities in mother's breast milk.

Biotransformation/Metabolism

Oxytocinase is a glycoprotein aminopeptidase that is produced during pregnancy and appears in the plasma. It is capable of degrading oxytocin. It is produced from both the mother and the foetus. Liver and kidney plays a major role in metabolising and clearing oxytocin from the plasma. Thus, liver, kidney and systemic circulation contribute to the biotransformation of oxytocin.

Elimination

Plasma half-life of oxytocin ranges from 3 to 20 min. The metabolites are excreted in urine whereas less than 1% of the oxytocin is excreted unchanged in urine. The metabolic clearance rate amounts to 20 mL/kg/ min in the pregnant woman.

Renal impairment

No studies have been performed in renally impaired patients. However, considering the excretion of oxytocin and its reduced urinary excretion because of anti-diuretic properties, the possible accumulation of oxytocin can result in prolonged action.

Hepatic impairment

No studies have been performed in hepatically impaired patients. Pharmacokinetic alteration in patients with impaired hepatic function is unlikely since metabolising enzyme, oxytocinase, is not confined to liver alone and the oxytocinase levels in placenta during the term has significantly increased. Therefore, biotransformation of oxytocin in impaired hepatic function may not result in substantial changes in metabolic clearance of oxytocin.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Posterior pituitary lobe hormones

Preclinical safety data

The information provided in Preclinical safety data of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

Pre-clinical data for A.A. Oxytocine reveal no special hazard for humans based on conventional studies of single dose acute toxicity, genotoxicity, and mutagenicity.

Pre-clinical data for oxytocin reveal no special hazard for humans based on conventional studies of single dose acute toxicity, genotoxicity, and mutagenicity.

Incompatibilities

The information provided in Incompatibilities of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
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A.A. Oxytocine should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by A.A. Oxytocine-inactivating enzymes. A.A. Oxytocine is incompatible with solutions containing sodium metabisulphite as a stabiliser.

A.A. Oxytocine should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by oxytocin-inactivating enzymes. A.A. Oxytocine is incompatible with solutions containing sodium metabisulphite as a stabiliser.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
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Snap ampoules: no file required.

A.A. Oxytocine is compatible with the following infusion fluids: sodium chloride 0.9 %, dextrose 5 %, Ringer's solution, acetated Ringer's solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Snap ampoules: no file required.

A.A. Oxytocine is compatible with the following infusion fluids, but due attention should be paid to the advisability of using electrolyte fluids in individual patients: sodium/potassium chloride (103mmol Na+ and 51mmol K+), sodium bicarbonate 1.39%, sodium chloride 0.9%, sodium lactate 1.72%, dextrose 5%, laevulose 20%, macrodex 6%, rheomacrodex 10%, Ringer's solution.

Name of the medicinal product
A.A. Oxytocine
Qualitative and quantitative composition
Oxytocin
Therapeutic indications
The information provided in Therapeutic indications of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
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Antepartum

• Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia)

• Stimulation of labour in hypotonic uterine inertia

• Early stages of pregnancy as adjunctive therapy for the management of incomplete, inevitable, or missed abortion

Postpartum

• During caesarean section, but following delivery of the child

• Prevention and treatment of postpartum uterine atony and haemorrhage

Antepartum

• Induction of labour for medical reasons, e.g. in cases of post-term gestation, premature rupture of the membranes, pregnancy-induced hypertension (pre-eclampsia)

• Stimulation of labour in hypotonic uterine inertia

• Early stages of pregnancy as adjunctive therapy for the management of incomplete, inevitable, or missed abortion.

Postpartum

• During caesarean section, but following delivery of the child

• Prevention and treatment of postpartum uterine atony and haemorrhage

Dosage (Posology) and method of administration
The information provided in Dosage (Posology) and method of administration of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
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Induction or enhancement of labour: A.A. Oxytocine should not be started for 6 hours following administration of vaginal prostaglandins.). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to A.A. Oxytocine, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by IV infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by IV infusion (5 IU diluted in physiological electrolyte solution and administered as an IV drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by IV infusion of a solution containing 5 to 20 IU of A.A. Oxytocine in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

Induction or enhancement of labour: Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins.“Special warnings and precautions for use”). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

Contraindications
The information provided in Contraindications of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet
<

• Hypertonic uterine contractions, mechanical obstruction to delivery, foetal distress.

Any condition in which, for foetal or maternal reasons, spontaneous labour is inadvisable and/or vaginal delivery is contra-indicated: e.g.:

• Significant cephalopelvic disproportion

• Foetal malpresentation

• Placenta praevia and vasa praevia

• Placental abruption

• Cord presentation or prolapse

• Overdistension or impaired resistance of the uterus to rupture as in multiple pregnancy

• Polyhydramnios

• Grand multiparity

• In the presence of a uterine scar resulting from major surgery including classical caesarean section.

A.A. Oxytocine should not be used for prolonged periods in patients with A.A. Oxytocine-resistant uterine inertia, severe pre-eclamptic toxaemia or severe cardiovascular disorders.

<).

<
Special warnings and precautions for use
The information provided in Special warnings and precautions for use of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

A.A. Oxytocine must only be administered as an IV infusion and never by IV bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.

Induction of labour

The induction of labour by means of A.A. Oxytocine should be attempted only when strictly indicated for medical reasons. Administration should only be under hospital conditions and qualified medical supervision.

Cardiovascular disorders

A.A. Oxytocine should be used with caution in patients who have a pre-disposition to myocardial ischaemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischaemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure and heart rate in these patients.

QT Syndrome

<).

When A.A. Oxytocine is given for induction and enhancement of labour:

• Foetal distress and foetal death: Administration of A.A. Oxytocine at excessive doses results in uterine overstimulation which may cause foetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or rupture of the uterus.

Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and duration of contractions) is essential, so that the dosage may be adjusted to individual response.

• Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension or cardiac disease, and in patients above 35 years of age or with a history of lower-uterine-segment caesarean section.

• Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labour using uterotonic agents, including A.A. Oxytocine increases the risk of postpartum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years of age or over, complications during pregnancy and gestational age more than 40 weeks. In these women, A.A. Oxytocine or any other alternative drug should be used with care, and the practitioner should be alerted by signs of DIC.

Intrauterine death

In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labour must be avoided, as it may cause amniotic fluid embolism.

Water intoxication

Because A.A. Oxytocine possesses slight antidiuretic activity, its prolonged IV administration at high doses in conjunction with large volumes of fluid, as may be the case in the treatment of inevitable or missed abortion or in the management of postpartum haemorrhage, may cause water intoxication associated with hyponatraemia. The combined antidiuretic effect of A.A. Oxytocine and the IV fluid administration may cause fluid overload leading to a haemodynamic form of acute pulmonary oedema without hyponatraemia. To avoid these rare complications, the following precautions must be observed whenever high doses of A.A. Oxytocine are administered over a long time: an electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by infusing A.A. Oxytocine at a higher concentration than recommended for the induction or enhancement of labour at term); fluid intake by mouth must be restricted; a fluid balance chart should be kept, and serum electrolytes should be measured when electrolyte imbalance is suspected.

Renal Impairment

Caution should be exercised in patients with severe renal impairment because of possible water retention and possible accumulation of A.A. Oxytocine .

”). To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute). In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated A.A. Oxytocine solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength, and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute .

Incomplete, inevitable, or missed abortion: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage: The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta. In women given A.A. Oxytocine for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage: 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes), followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Route of administration: Intravenous infusion.

Special populations

Renal impairment

No studies have been performed in renally impaired patients.

Hepatic impairment

No studies have been performed in hepatically impaired patients.

Paediatric population

No studies have been performed in paediatric patients.

Elderly population

No studies have been performed in elderly patients (65 years old and over).

4.3 Contraindications <4.4 Special warnings and precautions for use

A.A. Oxytocine must only be administered as an i.v. infusion and never by i.v. bolus injection as it may cause an acute short-lasting hypotension accompanied with flushing and reflex tachycardia.

Induction of labour

The induction of labour by means of oxytocin should be attempted only when strictly indicated for medical reasons. Administration should only be under hospital conditions and qualified medical supervision.

Cardiovascular disorders

A.A. Oxytocine should be used with caution in patients who have a pre-disposition to myocardial ischaemia due to pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischaemic heart disease including coronary artery vasospasm), to avoid significant changes in blood pressure and heart rate in these patients.

QT syndrome

<).

When A.A. Oxytocine is given for induction and enhancement of labour:

• Foetal distress and foetal death: Administration of oxytocin at excessive doses results in uterine overstimulation which may cause foetal distress, asphyxia and death, or may lead to hypertonicity, tetanic contractions or rupture of the uterus. Careful monitoring of foetal heart rate and uterine motility (frequency, strength, and duration of contractions) is essential, so that the dosage may be adjusted to individual response.

• Particular caution is required in the presence of borderline cephalopelvic disproportion, secondary uterine inertia, mild or moderate degrees of pregnancy-induced hypertension or cardiac disease, and in patients above 35 years of age or with a history of lower-uterine-segment caesarean section.

• Disseminated intravascular coagulation: In rare circumstances, the pharmacological induction of labour using uterotonic agents, including oxytocin increases the risk of post partum disseminated intravascular coagulation (DIC). The pharmacological induction itself and not a particular agent is linked to such risk. This risk is increased in particular if the woman has additional risk factors for DIC such as being 35 years of age or over, complications during pregnancy and gestational age more than 40 weeks. In these women, oxytocin or any other alternative drug should be used with care, and the practitioner should be alerted by signs of DIC.

Intrauterine death

In the case of foetal death in utero, and/or in the presence of meconium-stained amniotic fluid, tumultuous labour must be avoided, as it may cause amniotic fluid embolism.

Water intoxication

Because oxytocin possesses slight antidiuretic activity, its prolonged i.v. administration at high doses in conjunction with large volumes of fluid, as may be the case in the treatment of inevitable or missed abortion or in the management of postpartum haemorrhage, may cause water intoxication associated with hyponatraemia. The combined antidiuretic effect of oxytocin and the i.v. fluid administration may cause fluid overload leading to a haemodynamic form of acute pulmonary oedema without hyponatraemia. To avoid these rare complications, the following precautions must be observed whenever high doses of oxytocin are administered over a long time: an electrolyte-containing diluent must be used (not dextrose); the volume of infused fluid should be kept low (by infusing oxytocin at a higher concentration than recommended for the induction or enhancement of labour at term); fluid intake by mouth must be restricted; a fluid balance chart should be kept, and serum electrolytes should be measured when electrolyte imbalance is suspected.

Renal Impairement

Caution should be exercised in patients with severe renal impairment because of possible water retention and possible accumulation of oxytocin .

Anaphylaxis in women with latex allergy

There have been reports of anaphylaxis following administration of oxytocin in women with a known latex allergy. Due to the existing structural homology between oxytocin and latex, latex allergy/intolerance may be an important predisposing risk factor for anaphylaxis following oxytocin administration.

Effects on ability to drive and use machines
The information provided in Effects on ability to drive and use machines of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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A.A. Oxytocine can induce labour, therefore caution should be exercised when driving or operating machines. Women with uterine contractions should not drive or use machines.

Undesirable effects
The information provided in Undesirable effects of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

As there is a wide variation in uterine sensitivity, uterine spasm may be caused in some instances by what are normally considered to be low doses. When A.A. Oxytocine is used by IV infusion for the induction or enhancement of labour, administration at too high doses results in uterine overstimulation which may cause foetal distress, asphyxia, and death, or may lead to hypertonicity, tetanic contractions, soft tissue damage or rupture of the uterus.

<). These rapid haemodynamic changes may result in myocardial ischaemia, particularly in patients with pre-existing cardiovascular disease. Rapid IV bolus injection of A.A. Oxytocine at doses amounting to several IU may also lead to QTc prolongation.

<).

Water intoxication

<). Special warnings and precautions for use).

Symptoms of water intoxication include:

1. Headache, anorexia, nausea, vomiting and abdominal pain.

2. Lethargy, drowsiness, unconsciousness and grand-mal type seizures.

3. Low blood electrolyte concentration.

Undesirable effects (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports; not known (cannot be estimated from the available data). The ADRs tabulated below are based on clinical trial results as well as postmarketing reports.

The adverse drug reactions derived from post-marketing experience with A.A. Oxytocine are via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Table 1 Adverse drug reactions in mother

System organ class

Adverse drug reaction

Immune system disorders

Rare: Anaphylactic/Anaphylactoid reaction associated with dyspnoea, hypotension or Anaphylactic/Anaphylactoid Shock

Nervous system disorders

Common: Headache

Cardiac disorders

Common: Tachycardia, bradycardia

Uncommon: Arrhythmia

Not known: Myocardial ischaemia, Electrocardiogram QTc prolongation

Vascular disorders

Not known: Hypotension, haemorrhage

Gastrointestinal disorders

Common: Nausea, vomiting

Skin and subcutaneous tissue disorders

Rare: Rash

Pregnancy, puerperium and perinatal conditions

Not known: Uterine hypertonus, tetanic contractions of uterus, rupture of the uterus

Metabolism and nutrition disorders

Not known: Water intoxication, maternal hyponatraemia

Respiratory, thoracic and mediastinal disorders

Not known: acute pulmonary oedema

General disorders and administration site conditions

Not known: Flushing

Blood and lymphatic system disorders

Not known: disseminated intravascular coagulation

Skin and subcutaneous tissue disorders

Not Known: Angioedema

Table 2 Adverse drug reactions in foetus/neonate

System organ class

Adverse drug reaction

Pregnancy, puerperium and perinatal conditions

Not known: foetal distress, asphyxia and death

Metabolism and nutrition disorders

Not known: Neonatal hyponatraemia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard.

<).).

Water intoxication

<“Special warnings and precautions for use”). Special warnings and precautions for use).

Symptoms of water intoxication include:

1. Headache, anorexia, nausea, vomiting and abdominal pain.

2. Lethargy, drowsiness, unconsciousness and grand-mal type seizures.

3. Low blood electrolyte concentration.

Undesirable effects (Tables 1 and 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports; not known (cannot be estimated from the available data).The ADRs tabulated below are based on clinical trial results as well as postmarketing reports.

The adverse drug reactions derived from post-marketing experience with A.A. Oxytocine are via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

Table 1 Adverse drug reactions in mother

System organ class

Adverse drug reaction

Immune system disorders

Rare: Anaphylactic/Anaphylactoid reaction associated with dyspnoea, hypotension or Anaphylactic/Anaphylactoid shock

Nervous system disorders

Common: Headache

Cardiac disorders

Common Tachycardia, bradycardia

Uncommon: Arrhythmia

Not known: Myocardial ischaemia, Electrocardiogram QTc prolongation

Vascular disorders

Not known: Hypotension, haemorrhage

Gastrointestinal disorders

Common: Nausea, vomiting

Skin and subcutaneous tissue disorders

Rare: Rash

Pregnancy, puerperium and perinatal conditions

Not known: Uterine hypertonus, tetanic contractions of uterus, rupture of the uterus

Metabolism and nutrition disorders

Not known: Water intoxication, maternal hyponatraemia

Respiratory, thoracic and mediastinal disorders

Not known: acute pulmonary oedema

General disorders and administration site conditions

Not known: Flushing

Blood and lymphatic system disorders

Not known: disseminated intravascular coagulation

Skin and subcutaneous tissue disorders

Not Known: Angioedema

Table 2 Adverse drug reactions in foetus/neonate

System organ class

Adverse drug reaction

Pregnancy, puerperium and perinatal conditions

Not known: foetal distress syndrome, asphyxia and death

Metabolism and nutrition disorders

Not known: Neonatal hyponatraemia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.

Overdose
The information provided in Overdose of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Injection; Solution for injection and topical application; Solution for intravenous and intramuscular injection; Substance
Film-coated tablet

The fatal dose of A.A. Oxytocine has not been established. A.A. Oxytocine is subject to inactivation by proteolytic enzymes of the alimentary tract. Hence it is not absorbed from the intestine and is not likely to have toxic effects when ingested.

<8 Undesirable effects. In addition, as a result of uterine overstimulation, placental abruption and/or amniotic fluid embolism have been reported.

Treatment: When signs or symptoms of overdosage occur during continuous IV administration of A.A. Oxytocine, the infusion must be discontinued at once and oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur. In the case of coma, a free airway should be maintained with routine measures normally employed in the nursing of the unconscious patient.

<“Special warnings and precautions for use” and 4.8 “Undesirable effects”. In addition, as a result of uterine overstimulation, placental abruption and/or amniotic fluid embolism have been reported.

Treatment: When signs or symptoms of overdosage occur during continuous i.v. administration of A.A. Oxytocine, the infusion must be discontinued at once and oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur. In the case of coma, a free airway should be maintained with routine measures normally employed in the nursing of the unconscious patient.

Pharmacodynamic properties
The information provided in Pharmacodynamic properties of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Posterior pituitary lobe hormones

ATC code: H01B B02

Mechanism of action

A.A. Oxytocine is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to suckling and labour.

A.A. Oxytocine stimulates the smooth muscle of the uterus, more powerfully towards the end of pregnancy, during labour, and immediately postpartum. At these times, the A.A. Oxytocine receptors in the myometrium are increased.

The A.A. Oxytocine receptors are G-proteins coupled receptors. Activation of receptor by A.A. Oxytocine triggers release of calcium from intracellular stores and thus leads to myometrial contraction.

A.A. Oxytocine elicits rhythmic contractions in upper segment of uterus, similar in frequency, force and duration to those observed during labour.

Being synthetic, A.A. Oxytocine in A.A. Oxytocine does not contain vasopressin, but even in its pure form A.A. Oxytocine possesses some weak intrinsic vasopressin-like antidiuretic activity.

Based on in vitro studies, prolonged exposure of A.A. Oxytocine had been reported to cause desensitisation of A.A. Oxytocine receptors probably due to down-regulation of A.A. Oxytocine-binding sites, destabilisation of A.A. Oxytocine receptors mRNA and internalisation of A.A. Oxytocine receptors.

Plasma levels and onset/duration of effect

Intravenous infusion. When A.A. Oxytocine is given by continuous IV infusion at doses appropriate for induction or enhancement of labour, the uterine response sets in gradually and usually reaches a steady state within 20 to 40 minutes. The corresponding plasma levels of A.A. Oxytocine are comparable to those measured during spontaneous first-stage labour. For example, A.A. Oxytocine plasma levels in 10 pregnant women at term receiving a 4 milliunits per minute intravenous infusion were 2 to 5 microunits/mL. Upon discontinuation of the infusion, or following a substantial reduction in the infusion rate, e.g. in the event of overstimulation, uterine activity declines rapidly but may continue at an adequate lower level.

Pharmacotherapeutic group: Posterior pituitary lobe hormones

ATC code: H01B B02

Mechanism of action

Oxytocin is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to suckling and labour.

Oxytocin stimulates the smooth muscle of the uterus, more powerfully towards the end of pregnancy, during labour, and immediately postpartum. At these times, the oxytocin receptors in the myometrium are increased.

The oxytocin receptors are G-proteins coupled receptors. Activation of receptor by oxytocin triggers release of calcium from intracellular stores and thus leads to myometrial contraction.

Oxytocin elicits rhythmic contractions in upper segment of uterus, similar in frequency, force and duration to those observed during labour.

Being synthetic, oxytocin in A.A. Oxytocine does not contain vasopressin, but even in its pure form oxytocin possesses some weak intrinsic vasopressin-like antidiuretic activity.

Based on in vitro studies, prolonged exposure of oxytocin had been reported to cause desensitisation of oxytocin receptors probably due to down-regulation of oxytocin-binding sites, destabilisation of oxytocin receptors mRNA and internalisation of oxytocin receptors.

Plasma levels and onset/duration of effect

Intravenous infusion. When A.A. Oxytocine is given by continuous i.v. infusion at doses appropriate for induction or enhancement of labour, the uterine response sets in gradually and usually reaches a steady state within 20 to 40 minutes. The corresponding plasma levels of oxytocin are comparable to those measured during spontaneous first-stage labour. For example, oxytocin plasma levels in 10 pregnant women at term receiving a 4 milliunits per minute intravenous infusion were 2 to 5 microunits/mL. Upon discontinuation of the infusion, or following a substantial reduction in the infusion rate, e.g. in the event of overstimulation, uterine activity declines rapidly but may continue at an adequate lower level.

Pharmacokinetic properties
The information provided in Pharmacokinetic properties of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Absorption

Plasma levels of A.A. Oxytocine following intravenous infusion at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/mL.

Distribution

The steady-state volume of distribution determined in 6 healthy men after IV injection is 12.2 L or 0.17 L/kg. Plasma protein binding is negligible for A.A. Oxytocine. It crosses the placenta in both directions. A.A. Oxytocine may be found in small quantities in mother's breast milk.

Biotransformation/Metabolism

A.A. Oxytocinease is a glycoprotein aminopeptidase that is produced during pregnancy and appears in the plasma. It is capable of degrading A.A. Oxytocine. It is produced from both the mother and the foetus. Liver and kidney plays a major role in metabolising and clearing A.A. Oxytocine from the plasma. Thus, liver, kidney and systemic circulation contribute to the biotransformation of A.A. Oxytocine.

Elimination

Plasma half-life of A.A. Oxytocine ranges from 3 to 20 min. The metabolites are excreted in urine whereas less than 1% of the A.A. Oxytocine is excreted unchanged in urine. The metabolic clearance rate amounts to 20 mL/kg/ min in the pregnant woman.

Renal impairment

No studies have been performed in renally impaired patients. However, considering the excretion of A.A. Oxytocine and its reduced urinary excretion because of anti-diuretic properties, the possible accumulation of A.A. Oxytocine can result in prolonged action.

Hepatic impairment

No studies have been performed in hepatically impaired patients. Pharmacokinetic alteration in patients with impaired hepatic function is unlikely since metabolising enzyme, A.A. Oxytocinease, is not confined to liver alone and the A.A. Oxytocinease levels in placenta during the term has significantly increased. Therefore, biotransformation of A.A. Oxytocine in impaired hepatic function may not result in substantial changes in metabolic clearance of A.A. Oxytocine.

Absorption

Plasma levels of oxytocin following intravenous infusion at 4 milliunits per minute in pregnant women at term were 2 to 5 microunits/mL.

Distribution

The steady-state volume of distribution determined in 6 healthy men after i.v. injection is 12.2 L or 0.17 L/kg. Plasma protein binding is negligible for oxytocin. It crosses the placenta in both directions. Oxytocin may be found in small quantities in mother's breast milk.

Biotransformation/Metabolism

Oxytocinase is a glycoprotein aminopeptidase that is produced during pregnancy and appears in the plasma. It is capable of degrading oxytocin. It is produced from both the mother and the foetus. Liver and kidney plays a major role in metabolising and clearing oxytocin from the plasma. Thus, liver, kidney and systemic circulation contribute to the biotransformation of oxytocin.

Elimination

Plasma half-life of oxytocin ranges from 3 to 20 min. The metabolites are excreted in urine whereas less than 1% of the oxytocin is excreted unchanged in urine. The metabolic clearance rate amounts to 20 mL/kg/ min in the pregnant woman.

Renal impairment

No studies have been performed in renally impaired patients. However, considering the excretion of oxytocin and its reduced urinary excretion because of anti-diuretic properties, the possible accumulation of oxytocin can result in prolonged action.

Hepatic impairment

No studies have been performed in hepatically impaired patients. Pharmacokinetic alteration in patients with impaired hepatic function is unlikely since metabolising enzyme, oxytocinase, is not confined to liver alone and the oxytocinase levels in placenta during the term has significantly increased. Therefore, biotransformation of oxytocin in impaired hepatic function may not result in substantial changes in metabolic clearance of oxytocin.

Pharmacotherapeutic group
The information provided in Pharmacotherapeutic group of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Posterior pituitary lobe hormones
Preclinical safety data
The information provided in Preclinical safety data of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Pre-clinical data for A.A. Oxytocine reveal no special hazard for humans based on conventional studies of single dose acute toxicity, genotoxicity, and mutagenicity.

Pre-clinical data for oxytocin reveal no special hazard for humans based on conventional studies of single dose acute toxicity, genotoxicity, and mutagenicity.

Incompatibilities
The information provided in Incompatibilities of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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A.A. Oxytocine should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by A.A. Oxytocine-inactivating enzymes. A.A. Oxytocine is incompatible with solutions containing sodium metabisulphite as a stabiliser.

A.A. Oxytocine should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by oxytocin-inactivating enzymes. A.A. Oxytocine is incompatible with solutions containing sodium metabisulphite as a stabiliser.

Special precautions for disposal and other handling
The information provided in Special precautions for disposal and other handling of A.A. Oxytocine is based on data of another medicine with exactly the same composition as the A.A. Oxytocine of the medicine (Oxytocin). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug A.A. Oxytocine directly from the package or from the pharmacist at the pharmacy.
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Film-coated tablet

Snap ampoules: no file required.

A.A. Oxytocine is compatible with the following infusion fluids: sodium chloride 0.9 %, dextrose 5 %, Ringer's solution, acetated Ringer's solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Snap ampoules: no file required.

A.A. Oxytocine is compatible with the following infusion fluids, but due attention should be paid to the advisability of using electrolyte fluids in individual patients: sodium/potassium chloride (103mmol Na+ and 51mmol K+), sodium bicarbonate 1.39%, sodium chloride 0.9%, sodium lactate 1.72%, dextrose 5%, laevulose 20%, macrodex 6%, rheomacrodex 10%, Ringer's solution.

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