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Militian Inessa Mesropovna 、薬局による医学的評価、 最終更新日:23.03.2022
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Ergo-M注射は、分 ⁇ の第3段階の積極的な管理と分 ⁇ 後出血の治療に使用されます。. Ergo-M注射は、筋肉内または静脈内注射によって投与できます。.
Ergo-M Injection should be used under medical supervision only
Adults:
Active Management of the Third Stage of Labour
Ergo-M Injection is administered (often in combination with synthetic oxytocin 5 units) intramuscularly as a dose of 500 micrograms following the delivery of the anterior shoulder of the infant or at the latest immediately after delivery of the baby.
Prevention and Treatment of Postpartum Haemorrhage
Doses of 200 micrograms to 500 micrograms of Ergo-M are given intramuscularly, following expulsion of the placenta or when bleeding occurs. In emergencies, Ergo-M Injection may be given intravenously at a dose of 250 micrograms to 500 micrograms.
Use in special populations
Patients with renal impairment or hepatic impairment
No studies have been performed in patients with renal or hepatic impairment.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties).
Paediatric population
No data are available.
Elderly
Not applicable.
Method of administration
Intramuscular injection is the recommended route.
Intravenous administration of Ergo-M Injection at a dose of 250 micrograms to 500 micrograms (by slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.
-。
-)。.
-一次または二次子宮慣性。.
-重度の高血圧、子 ⁇ 前症、子 ⁇ 。.
-重度の心臓障害。.
-重度の肝機能障害または腎機能障害。.
-閉塞性血管疾患、例えば. レイノー病/現象。
-セプシス。
小児集団。
利用可能なデータはありません。.
高齢者。
該当なし。.
投与方法。
筋肉内注射が推奨されるルートです。.
Ergo-M注射を250マイクログラムから500マイクログラム(ゆっくり注射による)の用量で静脈内投与することは可能ですが、子宮アトニーによる重度の出血の場合にのみ使用を制限する必要があります。.
4.3禁 ⁇ 。-。
-)。.
-一次または二次子宮慣性。.
-重度の高血圧、子 ⁇ 前症、子 ⁇ 。.
-重度の心臓障害。.
-重度の肝機能障害または腎機能障害。.
-閉塞性血管疾患、例えば. レイノー病/現象。
-セプシス。
4.4特別な警告および使用上の注意。Ergo-Mは、広範囲にわたる血管収縮を引き起こし、まれに急性肺水腫を引き起こす可能性があります。.
労働の第3段階を積極的に管理するには、専門家の産科監督が必要です。.
エルゴM誘導体は母乳中に排 ⁇ されますが、量は不明です。.)。.
軽度または中等度の高血圧の患者、または軽度または中等度の心臓、肝臓、または腎臓病の患者には注意が必要です。. 重度の形態は禁 ⁇ です。.
冠動脈疾患の患者は、狭心症または心筋虚血およびErgo-M誘発血管けいれんによって引き起こされる ⁇ 塞に対してより感受性が高い可能性があります。.
産後出血の治療において、出血が注射によって逮捕されない場合、胎盤の破片が保持されている可能性、または軟部組織の損傷( ⁇ 部または ⁇ の裂傷)の可能性、または凝固欠陥の可能性を考慮し、適切な対策を講じてからさらに注射を行います。.
麦角アルカロイドはCYP3A4の基質です。.)。.
Receiving Ergo-M Injection can start labour. Women with contractions should not drive or use machines. Patients should be warned of the possibility of dizziness and hypotension.
免疫系障害。
呼吸困難、低血圧、虚脱またはショックの関連する症状を伴うアナフィラキシー/アナフィラキシー様反応。
神経系障害。
頭痛、めまい。
耳と迷路の障害。
耳鳴り。
心臓障害。
<)。血管障害。
高血圧、血管収縮。
呼吸器疾患。
呼吸困難、肺水腫。
胃腸障害。
吐き気、 ⁇ 吐、腹痛。
皮膚および皮下組織障害。
皮膚の発疹。
疑わしい副作用の報告。
医薬品の承認後に疑わしい副作用を報告することは重要です。. これにより、医薬品の利益/リスクバランスを継続的に監視できます。.
医療専門家は、イエローカードスキームのウェブサイト(www.mhra.gov.uk/yellowcard)を介して疑わしい副作用を報告するか、Google PlayまたはApple App StoreでMHRAイエローカードを検索するよう求められます。.
Symptoms of acute poisoning include nausea, vomiting, diarrhoea, extreme thirst, coldness, tingling and itching of the skin, tachycardia, vasospastic reactions, respiratory depression, confusion, convulsions and coma. Angina, hypertension or hypotension may also occur.
In cases of oral ingestion, although the benefit of gastric decontamination is uncertain, activated charcoal may be given to patients who present within 1 hour of ingesting a toxic dose (more than 125 micrograms/kg in adults) or any amount in a child or in adults with peripheral vascular disease, ischaemic heart disease, severe infection, or hepatic or renal impairment. Alternatively, gastric lavage may be considered in adults within 1 hour of ingesting a potentially life-threatening overdose.
In both acute and chronic poisoning by all routes, attempts must be made to maintain an adequate circulation to the affected parts of the body in order to prevent the onset of gangrene. In severe arterial vasospasm, vasodilators such as sodium nitroprusside by intravenous infusion have been given; heparin and dextran 40 have also been advocated to minimise the risk of thrombosis. Analgesics may be required for severe ischaemic pain.
Accidental administration of Ergo-M-containing medicinal products to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms such as respiratory depression, convulsions, cyanosis, oliguria, hypertonia and heart arrhythmia have been reported. Treatment has been symptomatic in most cases; respiratory and cardiovascular support have been required.
薬物療法グループ:麦角アルカロイド。
ATCコード:G02AB03。
Ergo-Mは、筋膜5-HT2受容体とα-アドレナリン受容体でアゴニストまたは部分的なアゴニスト効果を介して持続的な強壮性子宮収縮を生成します。. 上子宮と下子宮の両方のセグメントが刺激され、破傷風に収縮します。. オキシトシンとは異なり、Ergo-Mは妊娠していない子宮に影響を与えます。. エルゴMはプロラクチン分 ⁇ を阻害し、次に授乳を減らすことができます。. 子宮刺激は、筋肉内注射から7分以内に発生し、静脈内注射のほぼ直後に発生します。. Ergo-Mによって生成された持続的な子宮収縮は、子宮出血の制御に効果的です。.
Ergo-Mは、特定の血管のドーパミン作動性受容体で弱い ⁇ 抗作用を持っています。. 他の麦角アルカロイドと比較して、心血管系および中枢神経系に対するErgo-Mの影響はあまり顕著ではありません。. 血管に部分的なアゴニスト作用があり(エルゴタミン未満)、 ⁇ ±アドレナリン受容体で ⁇ 抗作用がほとんどまたはまったくありません。.
Paediatric population
No data are available.
Elderly
Not applicable.
Method of administration
Intramuscular injection is the recommended route.
Intravenous administration of Ergo-M Injection at a dose of 250 micrograms to 500 micrograms (by slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.
4.3 Contraindications-
- ).
- Primary or secondary uterine inertia.
- Severe hypertension, pre-eclampsia, eclampsia.
- Severe cardiac disorders.
- Severe hepatic or renal impairment.
- Occlusive vascular disease e.g. Raynaud's disease / phenomenon
- Sepsis
4.4 Special warnings and precautions for useErgo-M may give rise to widespread vasoconstriction and rarely acute pulmonary oedema.
Active management of the third stage of labour requires expert obstetric supervision.
Ergo-M derivatives are excreted in breast milk but in unknown amounts.).
Caution is required in patients with mild or moderate hypertension, or with mild or moderate degrees of cardiac, liver or kidney disease. Severe forms are contraindications.
Patients with coronary artery disease may be more susceptible to angina or myocardial ischaemia and infarction caused by Ergo-M-induced vasospasm.
If in the treatment of postpartum haemorrhage, bleeding is not arrested by the injection, the possibility of a retained placental fragment, or soft tissue injury (cervical or vaginal laceration), or of a clotting defect should be considered and appropriate measures taken before a further injection is given.
Ergot alkaloids are substrates of CYP3A4.).
4.5 Interaction with other medicinal products and other forms of interactionConcomitant use of Ergo-M Injection with the following medicinal products is not recommended:
Vasoconstrictors/Sympathomimetics
Ergo-M Injection may enhance the vasopressor effects of vasoconstrictors and sympathomimetics, even those contained in local anaesthetics.
Prostaglandins and their analogues
Prostaglandins and their analogues facilitate contraction of the myometrium hence Ergo-M Injection can potentiate the uterine action of prostaglandins and analogues and vice versa.
CYP3A4 inhibitors
Strong CYP3A4 inhibitors such as protease inhibitors, macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, delavirdine), azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), quinolones might raise the levels of ergot derivatives, which may lead to ergotism. Combined use with Ergo-M should be avoided. Other weaker CYP3A4 inhibitors (e.g cimetidine, delavirdine, grapefruit juice, quinupristin, dalfopristin) might interact similarly, although possibly to a lesser extent.
Ergot alkaloids/ergot derivatives
Concurrent use of other ergot alkaloids (e.g methysergide) and other ergot derivatives can increase the risk of severe and persistent spasm of major arteries in some patients.
Triptans
Additive vasoconstriction may occur when Ergo-M is concomitantly given with triptans (e.g. sumatriptan, zolmitriptan, rizatriptan, almotriptan, eletriptan).
Beta-blockers
Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.
Glyceryl trinitrate and other antianginal drugs
Ergo-M produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs.
Consideration should be given to the concomitant use of Ergo-M Injection with the following medicinal products:
Inhalation anaesthetics
Inhalation anaesthetics (e.g. halothane, cyclopropane, sevoflurane, desflurane, isoflurane) have a relaxing effect on uterus and produce a notable inhibition of uterine tone and thereby, may diminish the uterotonic effect of Ergo-M.
CYP3A4 inducers
CYP3A4 inducers (e.g nevirapine, rifampicin) may reduce the clinical effect of Ergo-M.
4.6 Fertility, pregnancy and lactationPregnancy
Ergo-M has potent uterotonic activity. Therefore, Ergo-M Injection is contraindicated during pregnancy, during induction of labour, and during first and second stage labour prior to the delivery of the anterior shoulder.
Breast-feeding
Ergo-M derivatives are excreted in breast milk but in unknown amounts. There is no specific data available for elimination of Ergo-M partitioned in breast-milk. Ergo-M can inhibit prolactin secretion and in turn can suppress lactation, so its repeated use should be avoided.
4.7 Effects on ability to drive and use machinesReceiving Ergo-M Injection can start labour. Women with contractions should not drive or use machines. Patients should be warned of the possibility of dizziness and hypotension.
4.8 Undesirable effectsImmune system disorders
Anaphylactic/Anaphylactoid reactions with associated symptoms of dyspnoea, hypotension, collapse or shock
Nervous system disorders
Headache, dizziness
Ear & labyrinth disorders
Tinnitus
Cardiac disorders
<)Vascular disorders
Hypertension, vasoconstriction
Respiratory disorders
Dyspnoea, pulmonary oedema
Gastrointestinal disorders
Nausea, vomiting, abdominal pain
Skin & subcutaneous tissue disorders
Skin rashes
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 OverdoseSymptoms of acute poisoning include nausea, vomiting, diarrhoea, extreme thirst, coldness, tingling and itching of the skin, tachycardia, vasospastic reactions, respiratory depression, confusion, convulsions and coma. Angina, hypertension or hypotension may also occur.
In cases of oral ingestion, although the benefit of gastric decontamination is uncertain, activated charcoal may be given to patients who present within 1 hour of ingesting a toxic dose (more than 125 micrograms/kg in adults) or any amount in a child or in adults with peripheral vascular disease, ischaemic heart disease, severe infection, or hepatic or renal impairment. Alternatively, gastric lavage may be considered in adults within 1 hour of ingesting a potentially life-threatening overdose.
In both acute and chronic poisoning by all routes, attempts must be made to maintain an adequate circulation to the affected parts of the body in order to prevent the onset of gangrene. In severe arterial vasospasm, vasodilators such as sodium nitroprusside by intravenous infusion have been given; heparin and dextran 40 have also been advocated to minimise the risk of thrombosis. Analgesics may be required for severe ischaemic pain.
Accidental administration of Ergo-M-containing medicinal products to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms such as respiratory depression, convulsions, cyanosis, oliguria, hypertonia and heart arrhythmia have been reported. Treatment has been symptomatic in most cases; respiratory and cardiovascular support have been required.
5. Pharmacological properties 5.1 Pharmacodynamic propertiesPharmacotherapeutic group: Ergot alkaloids
ATC code: G02AB03
Ergo-M produces sustained tonic uterine contraction via agonist or partial agonist effects at myometrial 5-HT2 receptors and alpha-adrenergic receptors. Both upper and lower uterine segments are stimulated to contract in a tetanic manner. Unlike oxytocin Ergo-M has an effect on the non-pregnant uterus. Ergo-M inhibits prolactin secretion and in turn can reduce lactation. Uterine stimulation occurs within 7 minutes of intramuscular injection and almost immediately following intravenous injection. The sustained uterine contractions produced by Ergo-M are effective in controlling uterine haemorrhage.
Ergo-M has weak antagonist actions at dopaminergic receptors in certain blood vessels. Compared with other ergot alkaloids, effects of Ergo-M on cardiovascular and central nervous system are less pronounced. It has a partial agonist action in blood vessels (less than ergotamine) and has little or no antagonist action at α adrenergic receptors.
5.2 Pharmacokinetic propertiesAbsorption
Ergo-M is rapidly absorbed after administration by mouth or by intramuscular injection. Uterotonic effect can be observed within 10 minutes following oral administration and within 7 minutes of intramuscular injection.
Distribution
The average steady state volume of distribution of Ergo-M in healthy man is reported to be 1.04 L/kg. The plasma protein binding of Ergo-M is unknown. Ergo-M is known to cross the placenta and its clearance from the foetus is slow. Concentrations of Ergo-M achieved in foetus are not known. Ergo-M is also expected to be excreted in the breast milk and to reduce milk secretion.
Metabolism/Biotransformation
Ergo-M is mainly metabolised in the liver by hydroxylation and glucuronic acid conjugation and possibly N-demethylation. Like other ergot alkaloids it is a substrate for CYP3A4 enzymes.
Elimination
The plasma half life of Ergo-M is reported to be in the range of 30-120 min. When administered orally, the drug is mainly eliminated with the bile into the faeces as 12-hydroxyErgo-M glucuronide. It is eliminated unchanged in the urine and can be detected up to 8 h after injection.
製品特性の要約の他のセクションにすでに含まれているものに追加される、処方者に関連する前臨床データはありません。.
Ergo-M注射は、結果として生じるPh、薬物の温度および濃度に応じて、さまざまな薬物と両立しません。. したがって、同じシリンジ内の他の薬物との混合は避けてください。. ただし、Ergo-Mは、IV投与前に0.9%塩化ナトリウム注射で5mlsの容量に希釈することができます。.
未使用の医薬品または廃棄物は、地域の要件に従って廃棄する必要があります。.