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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 27.03.2022

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Name of the medicinal product

31.12.1899 4:01:00

Qualitative and quantitative composition

Amoxicillin

Therapeutic indications

Film-coated tablets

Modified-release film-coated tablets

Powder

For all dosage forms of Infections caused by sensitive strains of microorganisms: upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis)

The drug Augmentin® CP is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

respiratory tract infections, such as community-acquired pneumonia, exacerbation of chronic bronchitis, acute bacterial sinusitis, usually caused by Streptococcus pneumoniae (including penicillin-resistant strains), Haemophilus influenzae1, Moraxella catarrhalis1 and Streptococcus pyogenes

prevention of local infections after surgery in dentistry.

¹ Некоторые штаммы этих бактерий продуцируют бета-лактамазы, что делает их нечувствительными к монотерапии амоксициллином.

Infections caused by amoxicillin-sensitive microorganisms can be treated with Augmentin ® CP, as amoxicillin is one of its active ingredients. The drug Augmentin® CP is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as beta-lactamase-producing microorganisms sensitive to the combination of amoxicillin with clavulanic acid.

The drug Augmentin® CP demonstrated efficacy against S. pneumoniae strains resistant to penicillin (strains with MPC ≥2 mg / L).

Drugs containing a combination of amoxicillin with clavulanic acid should be used in accordance with the Russian guidelines for antibiotic therapy and regional data on the sensitivity of pathogens to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.

Respiratory tract infections (acute and chronic bronchitis, lobar and bronchopneumonia, pleural empyema, lung abscess, ear, nose and throat infections)

It is also used for the prevention of infections that are associated with major surgical operations on the gastrointestinal tract, in the pelvis, head and neck, on the heart, kidneys, and bile ducts.

Dosage (Posology) and method of administration

Film-coated tablets

Jelly beans

Modified-release film-coated tablets

Powder

Coated tablets

Amoxiclav® Tablets, film-coated Inside. The dosage regimen is set individually, depending on the age, body weight, kidney function of the patient, as well as the severity of the infection. Amoxiclav® is recommended to be taken at the beginning of a meal for optimal absorption and to reduce possible side effects from the digestive system. The course of treatment is 5 to 14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not last more than 14 days without a second medical examination. Children under 12 years of age The dose is prescribed depending on age and body weight. The recommended dosage regimen is 40 mg / kg / day in 3 doses. Children with a body weight of 40 kg or more should be prescribed the same doses as adults. For children aged less than 6 years, it is more preferable to take a suspension of the drug Amoxiclav®. Adults and children over 12 years of age (or >40 kg of body weight) The usual dose in the case of mild to moderate infection is 1 table. 250 125 mg every 8 hours or 1 table. 500 125 mg every 12 hours, in case of severe infection and respiratory tract infections - 1 table. 500 125 mg every 8 hours or 1 table. 875 125 mg every 12 hours. Since the tablets of the combination of amoxicillin and clavulanic acid of 250 125 mg and 500 125 mg each contain the same amount of clavulanic acid-125 mg, then 2 tables. 250 125 mg is not equivalent to 1 table. 500 125 mg. Dosage for odontogenic infections 1 table. 250 125 mg every 8 hours or 1 table. 500 125 mg every 12 hours for 5 days. Patients with impaired renal function Dose adjustment is based on the maximum recommended dose of amoxicillin and is carried out taking into account the values of creatinine Cl: - adults and children over 12 years of age (or ≥40 kg of body weight) (Table. 2). Table 2 Creatinine clearance Amoxiclav ® dosage regimen >30 ml / min No dose adjustment required 10-30 ml / min 1 Table. 50 125 mg 2 times a day or 1 table. 250 125 mg (for mild and moderate infection) 2 times a day <10 ml / min 1 table. 500 125 mg 1 time per day or 1 table. 250 125 mg (for mild and moderate infection) 1 time per day Hemodialysis 1 table. 500 125 mg or 2 tablets. 250 125 mg every 24 hours 1 table. 500 125 mg or 2 tablets. 250 125 mg during dialysis and at the end of the dialysis session (due to a decrease in serum concentrations of amoxicillin and clavulanic acid) Patients with impaired liver function Should take Amoxiclav® with caution. It is necessary to conduct regular monitoring of liver function. Powder for preparation of suspension for oral administration Daily dose of suspensions 125 31.25 mg/5 ml and 250 62.5 mg/5 ml (to facilitate correct dosing, a dosage pipette graduated by 5 ml with a division scale of 0.1 ml or a dosage spoon with a capacity of 5 ml, with ring marks in the cavity of 2.5 and 5 ml is inserted into each package of suspensions 125 31.25 mg/5 ml and 250 62.5 mg/5 ml). Newborns and children under 3 months — 30 mg / kg / day (according to amoxicillin), divided into 2 doses (every 12 hours). Dosage of Amoxiclav® with a dosing pipette-calculation of single doses for the treatment of infections in newborns and children up to 3 months (Table. 3). Table 3 Body weight, kg 2 2,2 2,4 2,6 2,8 3 3,2 3,4 3,6 3,8 4 4,2 4,4 4,6 4.8 Suspension 156.25, ml (2 times a day) 1,2 1,3 1,4 1,6 1,7 1,8 1,9 2 2,2 2,3 2,4 2,5 2,6 2,8 2,9 Suspension 312,5, ml (2 times a day) 0,6 0,7 0,7 0,8 0,8 0,9 1 1 1,1 1,1 1,2 1,3 1,3 1,4 1,4 Children older than 3 months-from 20 mg / kg for mild and moderate infections to 40 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis (amoxicillin) per day, divided into 3 doses (every 8 hours). Dosage of Amoxiclav® with a dosing pipette-calculation of single doses for the treatment of mild and moderate infections in children older than 3 months (at the rate of 20 mg/kg/day (according to amoxicillin) (Table. 4). 5). 6). From 25 mg / kg - for mild and moderate infections to 45 mg/kg-for severe infections and lower respiratory tract infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses. To facilitate correct dosing, a dosing pipette is inserted into each package of 400 mg 57 mg/5 ml suspension, graduated simultaneously into 1, 2, 3, 4, 5 ml and into 4 equal parts. Suspension 400 mg 57 mg/5 ml is used in children older than 3 months. Table 7 Recommended suspension dose depending on the child's body weight and the severity of the infection Body weight, kg Age (approximately) Recommended dose, ml Severe course Moderate course 5-10 3-12 months 2×2.5 2×1.25 10-15 1-2 years 2×3.75 2×2.5 15-20 2-4 years 2×5 2×3.75 20-30 4 years — 6 years 2×7.5 2×5 30-40 6-10 years 2×10 2×6.5 The exact daily doses are calculated based on the child's body weight, not his age. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg for children. The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg for children. In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin. Patients with creatinine Cl >30 ml / min do not require any dose adjustment. Adults and children weighing more than 40 kg (the indicated dosage regimen is used for moderate and severe infections) Patients with creatinine Cl 10-30 ml / min-500/125 mg 2 times a day. When creatinine Cl <10 ml / min, the recommended dose is 500/125 mg once a day. For patients on hemodialysis, the recommended dose is 500/125 mg every 24 hours, plus 500/125 mg during dialysis and another dose at the end of dialysis (t.to. serum concentrations of amoxicillin and clavulanic acid are reduced). Children weighing less than 40 kg With a creatinine Cl of 10-30 ml / min the recommended dose is 15/3. 75 mg / kg 2 times a day (maximum 500/125 mg 2 times a day). With creatinine Cl <10 ml / min, the recommended dose is 15/3. 75 mg / kg once a day (maximum 500/125 mg). For hemodialysis, the recommended dose is 15/3. 75 mg / kg once a day. Before hemodialysis — 15/3, 75 mg / kg. To restore the appropriate concentrations of the drug in the blood,it is necessary to take another dose of 15/3. 75 mg/kg after hemodialysis. The course of treatment is 5 to 14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not last more than 14 days without a second medical examination. Instructions for preparing the suspension Powder for preparing the suspension 125 31.25 mg/5ml-shake the bottle vigorously, add 86 ml of water in two doses (up to the mark), each time shaking well until the powder is completely dissolved. Powder for the preparation of suspension 250 62.5 mg/5ml-shake the bottle vigorously, add 85 ml of water in two doses (up to the mark), each time shaking well until the powder is completely dissolved. Powder for the preparation of suspension 400 mg 57 mg/5 ml-shake the bottle vigorously, add water in two doses (up to the label) in the amount indicated on the label and shown in the table, each time shaking well until the powder is completely dissolved. Table 8 Volume of the finished suspension, ml Required amount of water, ml 35 29.5 50 42 70 59 140 118 Shake vigorously before use! To prepare the suspension, it is recommended to dilute the powder with boiled water at room temperature. It is recommended to place the finished suspension in the refrigerator. It is not recommended to heat the suspension before use (it is necessary to bring the suspension to room temperature). After taking the drug, it is recommended to rinse the dosage pipette with boiled water. Powder for the preparation of a solution for intravenous administration of intravenous. Children: with a body weight of less than 40 kg-the dose is calculated depending on the body weight. Under 3 months with a body weight of less than 4 kg — 30 mg/kg (in terms of the entire drug Amoxiclav®) every 12 hours. Under 3 months with a body weight of more than 4 kg — 30 mg/kg (in terms of the entire drug Amoxiclav®) every 8 hours. In children younger than 3 months, the drug Amoxiclav® should be administered only slowly by infusion for 30-40 minutes. Children from 3 months to 12 years — 30 mg / kg (in terms of the entire drug Amoxiclav®) at an interval of 8 hours, in the case of severe infection - at an interval of 6 hours. Children with impaired renal function Dose adjustment is based on the maximum recommended dose of amoxicillin. In patients with creatinine Cl values above 30 ml/min, dose adjustment is not necessary. Children weighing <40 kg: Cl creatinine 10-30 ml / min 25 mg / 5 mg per 1 kg every 12 h Cl creatinine <10 ml / min 25 mg/5 mg per 1 kg every 24 h Hemodialysis 25 mg/5 mg per 1 kg every 24 h plus a dose of 12.5 mg/2.5 mg per 1 kg at the end of the dialysis session (due to a decrease in the concentration of amoxicillin and clavulanic acid in the serum) Every 30 mg of Amoxiclav ® contains 25 mg of amoxicillin and 5 mg of clavulanic acid. Adults and children over 12 years of age or weighing more than 40 kg — 1.2 g of the drug (1000 200 mg) at an interval of 8 hours, in the case of severe infection - at an interval of 6 hours. Prophylactic doses for surgical interventions: 1.2 g for introductory anesthesia (if the duration of the operation is less than 2 hours). For longer operations-1.2 g up to 4 times during the day. In peritoneal dialysis, dose adjustment is not required. The course of treatment is 5 to 14 days. The duration of the course of treatment is determined by the attending physician. With a decrease in the severity of symptoms, it is recommended to switch to oral forms of the drug Amoxiclav®to continue therapy. Preparation of solutions for intravenous injection. Dissolve the contents of the vial in water for injection: 600 mg (500 100 mg) - in 10 ml of water for injection or 1.2 g (1000 200 mg) - in 20 ml of water for injection. The solution is administered slowly (over 3-4 min). The drug Amoxiclav® should be administered within 20 minutes after the preparation of solutions for intravenous administration. Preparation of solutions for intravenous infusions. For infusion administration of Amoxiclav®, further dilution is necessary: prepared solutions containing 600 mg (500 100 mg) or 1.2 g (1000 200 mg) of the drug should be diluted in 50 or 100 ml of the infusion solution, respectively. The duration of the infusion is 30-40 minutes. When using the following liquids in the recommended volumes, the necessary concentrations of the antibiotic are maintained in infusion solutions: Used liquids Stability period, h at 25 °C at 5 °C Water for injection 4 8 Sodium chloride solution 0.9% for intravenous infusions 4 8 Ringer lactate solution for intravenous infusions 3 Calcium chloride and sodium chloride solution for intravenous infusions 3 Amoxiclav® solution should not be mixed with dextrose, dextran or sodium bicarbonate solutions. Only clear solutions should be used. Prepared solutions should not be frozen. Amoxiclav® Quicktab Inside. The dosage regimen is set individually depending on the age, body weight, kidney function of the patient and the severity of the infection. Tablets should be dissolved in half a glass of water (at least 30 ml) and thoroughly mixed, then drink or hold the tablets in your mouth until completely dissolved, then swallow. In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug at the beginning of a meal. Dispersible tablets of the drug Amoxiclav®Quicktab 500 mg / 125 mg: Adults and children over 12 years of age with a body weight of ≥40 kg For the treatment of mild and moderate infections — 1 table. (500 mg/125 mg) every 12 hours (2 times a day). For the treatment of severe infections and respiratory infections — 1 table. (500 mg/125 mg) every 8 hours (3 times a day). The maximum daily dose of the drug Amoxiclav®Quicktab is 1500 mg of amoxicillin/375 mg of clavulanic acid. Patients with impaired renal function. In patients with creatinine Cl above 30 ml/min, there is no need for dose adjustment. Adults and children over 12 years of age with a body weight of ≥40 kg (the indicated dosage regimen is used for moderate and severe infections): Cl creatinine, ml / min Dose of 10-30 500 mg/125 mg 2 times a day (for moderate and severe infections) <10 500 mg/125 mg 1 time a day (for moderate and severe infections) Hemodialysis 500 mg/125 mg every 24 hours, plus 500 mg/125 mg during a dialysis session, with repeated use at the end of the dialysis session (t.to. the concentrations of amoxicillin and clavulanic acid in the blood plasma are reduced) Dispersible tablets of the drug Amoxiclav®Quicktab 875 mg / 125 mg: Adults and children over 12 years of age with a body weight of ≥40 kg In severe infections and respiratory infections — 1 table. (875 mg/125 mg) every 12 hours (2 times a day). Daily dose of the drug Amoxiclav®Quicktab when used 2 times a day is 1750 mg of amoxicillin/250 mg of clavulanic acid. Patients with impaired renal function. In patients with a creatinine Cl of more than 30 ml/min, there is no need for dose adjustment. Patients with creatinine Cl less than 30 ml / min using dispersible tablets of Amoxiclav®Quicktab, 875 mg/125 mg is contraindicated. Such patients should take the drug at a dosage of 500 mg/125 mg after a dose adjustment corresponding to the level of Cl creatinine. Patients with impaired liver function. When taking the drug Amoxiclav®Quicktab should be careful. It is necessary to conduct regular monitoring of liver function. In the case of starting treatment with parenteral administration of the drug, therapy can be continued by taking tablets of the drug Amoxiclav®Quicktab. The duration of the course of treatment is determined by the attending physician! The minimum course of antibacterial therapy is 5 days. Treatment should not last more than 14 days without reviewing the clinical situation

Inside, washed down with water

Film-coated tablets

Adults and children over 12 years of age (body weight ≥40 kg)

Take 1 tablet. 2 times a day, every 12 hours.

The maximum daily dose of amoxicillin for adults is 6 g, for children-45 mg / kg / day.

The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children-10 mg/kg / day.

The course of treatment — 5-14 days

Dosage for renal failure

Tablets 875/125 mg should be used only in patients with a creatinine Cl of more than 30 ml / min, and no dose adjustment is required.

Patients on peritoneal dialysis do not need to adjust the dose. Patients on hemodialysis may need to adjust the dose of the drug.

Powder for preparation of suspension for oral administration

Dose with a measuring spoon, taking into account that 5 ml of the finished suspension contains amoxicillin 400 mg/clavulanic acid 57 mg. Drink 0.5-1 cup of water.

The dose of Panclav 2X is prescribed by a doctor, taking into account the characteristics of the pathogen, localization and severity of the infection. The dosage regimen is set individually, depending on age, body weight (for children) and kidney function. The course of treatment — 5-14 days

For infections that require a long course of therapy (for example, osteomyelitis), exceeding the maximum recommended course of therapy of 14 days is possible only after a thorough assessment by the doctor of the patient's condition, the achieved and expected therapeutic effects and risks.

The maximum daily dose of amoxicillin for adults is 6 g, for children-45 mg / kg / day. The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children-10 mg/kg / day.

Adults and children over 12 years of age (body weight ≥40 kg)

Standard dosage regimen for all indications:

2 scoops (800/114 mg) 2 times a day, every 12 hours.

Children from 2 to 12 years (body weight ≥40 kg)

Daily dose (according to amoxicillin) The weight of the child According to the age of the finished suspension

25 mg / kg	13-21 kg	2-6 years old	2.5 ml 2 times a day
	22-40 kg	7-12 years old	5 ml 2 times a day
45 mg / kg	13-21 kg	2-6 years old	5 ml 2 times a day
	22-40 kg	7-12 years old	10 ml 2 times a day

Children from 3 months to 3 years old

Child weight Daily dose of 25 mg / kg (according to amoxicillin) The daily dose is 45 mg / kg (according to amoxicillin)

5 kg	0.8 ml 2 times a day	1.4 ml 2 times a day
6 kg	0.9 ml 2 times a day	1.7 ml 2 times a day
7 kg	1.1 ml 2 times a day	2 ml 2 times a day
8 kg	1.3 ml 2 times a day	2.3 ml 2 times a day
9 kg	1.4 ml 2 times a day	2.5 ml 2 times a day
10 kg	1.6 ml 2 times a day	2.8 ml 2 times a day
11 kg	1.7 ml 2 times a day	3.1 ml 2 times a day
12 kg	1.9 ml 2 times a day	3.4 ml 2 times a day

The daily dose for children older than 3 months and up to 12 years (body weight ≥40 kg) is 25-45 mg/kg / day (based on amoxicillin), divided into two doses, every 12 hours.Low doses of the drug (25 mg/kg/day) are used to treat skin and soft tissue infections, as well as recurrent tonsillitis. High doses of the drug (45 mg / kg / day) are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections. The duration of treatment of acute uncomplicated otitis media is 5-7 days, in children-7-10 days.

Children and adults with renal insufficiency

If the creatinine Cl is less than 30 ml / min, the drug at this dose is not recommended

Preparation of suspension for oral administration

In the bottle with the powder, gradually add water to the mark (distilled water or boiled and cooled) and shake until the powder is evenly wet (about 30 c). If the level of the prepared suspension is below the label on the bottle label, re-add water to the label and shake.

The finished suspension must be shaken before each meal.

Important! Если прием препарата пропущен, следует как можно скорее принять таблетку (или суспензию), не дожидаясь времени следующего приема. Далее соблюдать равные промежутки времени между приемами — по 12 ч. You should never take a double dose to make up for a missed medication!

Inside.

To optimize absorption, the drug should be taken at the beginning of a meal.

Treatment should not last more than 14 days without reviewing the clinical situation.

Tablets of the drug Augmentin® The SRS have a dividing groove that allows them to be broken in half for ease of ingestion, but not to reduce the dose: both halves must be taken simultaneously. The recommended dose of the drug is 2 tablets. 2 times a day.

Adults (16 years and older). Инфекции дыхательных путей: 2 табл. 2 раза в день в течение 7–10 дней, включая следующие заболевания:

- community-acquired pneumonia — 2 tables. 2 times a day for 7-10 days

- exacerbation of chronic bronchitis — 2 tables. 2 times a day for 7 days

- acute sinusitis of bacterial etiology — 2 tables. 2 times a day for 10 days.

Prevention of local infections after surgical dental interventions: 2 tables. 2 times a day for 5 days starting 3 hours after the intervention.

Special patient groups

Children under 16. Не применяется.

Elderly patients. Не требуется коррекция режима дозирования.

Patients with impaired renal function. Не требуется коррекция режима дозирования при Cl креатинина ≥30 мл/мин. Не рекомендуется назначение препарата пациентам с Cl креатинина <30 мл/мин.

Patients on hemodialysis. Не рекомендуется.

Impaired liver function. Лечение проводят с осторожностью; регулярно осуществляют мониторинг функции печени. Недостаточно данных для рекомендации режима дозирования для данной группы пациентов.

IV is administered slowly, for 3-4 minutes, no later than 20 minutes after dissolution. For the infusion, 600 mg of the substance is dissolved in 50 ml of the infusion solution or 1.2 g of the substance in 100 ml of the solution. The duration of the drip infusion is 30-40 minutes. The drug can be administered in various infusion solutions, except for glucose (dextrose) solution.

Adults and children over 12 years of age: 1.2 g every 8 hours, with more severe infections, the interval between injections is reduced to 6 hours.

Children from 3 months to 12 years: 30 mg / kg every 8 hours, with more severe infections, the interval between injections is reduced to 6 hours.

Children under 3 months: 30 mg / kg every 12 hours in premature infants and newborns, then the interval between injections is reduced to 8 hours.

30 mg of the intravenous drug contains 25 mg of amoxicillin and 5 mg of clavulanic acid.

In surgical practice, 31.12.1899 4: 01: 00 is used to protect against infection during surgery. Adults are given 1.2 g intravenously before anesthesia, if the intervention lasts more than an hour. The course of treatment can be extended for several days if the risk of infection was increased during the intervention. The drug should also be used in postoperative treatment.

With reduced renal function: adults with mild insufficiency (Creatinine Cl > 30 ml / min) there is no need to reduce the dosage

Treatment of adults and children can last 14 days, after which it is necessary to decide whether to continue antibacterial therapy or cancel it.

Inside, before or during meals. Adults and children over 12 years of age: moderate infections - 375 mg (1 table) 3 times a day

In case of impaired renal function, adults:

Cl creatinine clearance, ml/min Dosage

More than 30	No changes
10–30	375-750 mg every 12 hours
Less than 10	No more than 625 mg every 24 hours

Contraindications

Film-coated tablets

Modified-release film-coated tablets

Powder

hypersensitivity to the components of the drug

hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in the anamnesis

previous episodes of jaundice or impaired liver function when using a combination of amoxicillin with clavulanic acid in the anamnesis.

With caution: нарушения функции печени.

Hypersensitivity to penicillin antibiotics, infectious mononucleosis, lymphocytic leukemia.

Undesirable effects

Film-coated tablets

Modified-release film-coated tablets

Powder

Amoxiclav® film-coated tablets and powder for the preparation of a solution for intravenous administration From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black "hairy" tongue, darkening of tooth enamel, hemorrhagic colitis (also may develop after therapy), enterocolitis, pseudomembranous colitis, impaired liver function, increased activity of ALT, AST, ALP, and/or the level of bilirubin in the blood plasma, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis. Allergic reactions: pruritus, urticaria, erythematous rashes, erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, serum sickness-like syndrome, toxic epidermal necrolysis. From the hematopoietic system and the lymphatic system: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PV (when combined with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis. From the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug). From the urinary system: interstitial nephritis, crystalluria, hematuria. Other: candidiasis and other types of superinfection. Amoxiclav® For film-coated tablets, powder for preparing a suspension for oral administration, powder for preparing a solution for intravenous administration additionally From the central nervous system: hyperactivity. Anxiety, insomnia, behavior change, arousal. Amoxiclav® Amoxiclav® Quicktab Amoxiclav® Quicktab and Amoxiclav® powder for the preparation of a suspension for oral administration By the organs of hematopoiesis and the lymphatic system: rarely-reversible leukopenia (including neutropenia), thrombocytopenia.tsch. reversible hemolytic anemia. On the part of the immune system: the frequency is unknown-angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness. From the nervous system: infrequently-dizziness, headache. From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea. Nausea is more common when ingested at high doses. If gastrointestinal disorders are confirmed, they can be eliminated if you take the drug at the beginning of a meal. In children, very rarely there was a change in the color of the surface layer of tooth enamel. Oral care helps prevent discoloration of tooth enamel. From the skin: infrequently-skin rash, itching, urticaria. From the urinary system: very rarely-crystalluria, interstitial nephritis, hematuria. From the liver and biliary tract: infrequently-increased activity of ALT and / or AST (this phenomenon is observed in patients receiving beta-lactam antibiotics, but its clinical significance is unknown). These adverse events are very rarely observed in children. The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases, there have been reports of fatal outcomes. In almost all cases, these were patients with serious comorbidities or patients receiving potentially hepatotoxic drugs at the same time. Very rarely-increased activity of alkaline phosphatase, increased bilirubin, hepatitis, cholestatic jaundice (observed with concomitant therapy with other penicillins and cephalosporins). Other: often-candidiasis of the skin and mucous membranes

The adverse events presented below are listed according to the lesion of organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often - ≥1/10

Infectious and parasitic diseases: часто — генитальный монилиаз, кожно-слизистый кандидоз.

From the blood and lymphatic system: редко — обратимая лейкопения (включая нейтропению) и тромбоцитопения; очень редко — обратимые агранулоцитоз и гемолитическая анемия, увеличение времени кровотечения и ПВ.

On the part of the immune system: очень редко — ангионевротический отек, анафилактические реакции, синдром, сходный с сывороточной болезнью, аллергический васкулит.

From the nervous system: нечасто — головокружение, головная боль; очень редко — обратимые гиперактивность, судороги.

From the gastrointestinal tract: очень часто — диарея; часто — тошнота, абдоминальные боли; нечасто — рвота, расстройства пищеварения; очень редко — колиты, индуцированные приемом антибиотиков (включая псевдомембранозный колит и геморрагический колит), черный «волосатый» язык.

From the liver and biliary tract: нечасто — умеренное повышение активности ACT и/или АЛТ. Данное явление наблюдается у пациентов, получающих терапию бета-лактамными антибиотиками, однако клиническая значимость его неизвестна; очень редко — гепатит и холестатическая желтуха. Данное явление наблюдается у пациентов, получающих терапию антибиотиками пенициллинового ряда и цефалоспоринами.

Adverse events from the liver are observed mainly in men and elderly patients and may be associated with long-term therapy.

The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases, there have been reports of fatal outcomes. In almost all cases, these were patients with serious comorbidities or patients receiving potentially hepatotoxic drugs at the same time.

From the skin and subcutaneous tissues: нечасто — сыпь, зуд, крапивница; редко — многоформная эритема; очень редко — синдром Стивенса-Джонсона, токсический эпидермальный некролиз, буллезный эксфолиативный дерматит, острый генерализованный экзантематозный пустулез. В случае возникновения любых аллергических реакций лечение препаратом Аугментин^® СР необходимо прекратить.

From the kidneys and urinary tract: очень редко — интерстициальный нефрит, кристаллурия.

Dyspeptic phenomena (nausea, vomiting, diarrhea), allergic reactions (erythema, rash).

Overdose

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There are no reports of fatal or life-threatening side effects due to an overdose of the drug. Symptoms: in most cases — disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), possibly also anxiety, insomnia, dizziness, in isolated cases — convulsive seizures. Treatment: in case of overdose, the patient should be under the supervision of a doctor, treatment is symptomatic. In the case of recent administration (less than 4 hours) of the drug, gastric lavage should be performed and activated charcoal should be prescribed to reduce absorption. Amoxicillin / potassium clavulanate is removed by hemodialysis.

Symptoms: there may be symptoms from the gastrointestinal tract and violations of the water-electrolyte balance. Amoxicillin crystalluria is described, which in some cases led to the development of renal failure (see "Special instructions").

Treatment: симптомов со стороны ЖКТ — симптоматическая терапия, уделяя особое внимание нормализации водно-электролитного баланса. Амоксициллин и клавулановая кислота могут быть удалены из кровотока путем гемодиализа.

Symptoms: nausea, diarrhea, vomiting.

Treatment: symptomatic

Pharmacodynamic properties

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Amoxiclav® is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PSBs) on the pathway of the biosynthesis of peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually causes the lysis and death of microbial cells. Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of activity of amoxicillin does not include microorganisms that produce these enzymes. Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits certain beta-lactamases, thereby preventing the inactivation of amoxicillin and expanding the range of its activity, including bacteria that are usually resistant to amoxicillin, as well as to other penicillins and cephalosporins. Clavulanic acid itself does not have a clinically significant antibacterial effect. Amoxiclav ® has a bactericidal effect in vivo on the following microorganisms: - Gram-positive microbes-Staphylococcus aureus*, Streptococcus pneumoniae, Streptococcus pyogenes.** , Escherichia coli*, Haemophilus influenzae*, species of the genus Klebsiella*, Moraxella catarrhalis* (Branhamella catarrhalis). The drug Amoxiclav ® has a bactericidal effect in vitro on the following microorganisms (however, the clinical significance is still unknown): — gram-positive aerobes-Bacillis anthracis*, species of the genus Corynebacterium, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides, coagulase-negative staphylococci* (including Staphylococcus epidermidis), Streptococcus agalactiae, other species of the genus Streptococcus, Streptococcus viridans., Leptospira icterohaemorrhagiae, Treponema pallidum. * Some strains of these bacterial species produce beta-lactamases, which contributes to their insensitivity to amoxicillin monotherapy. ** Most strains of these bacteria are resistant to the amoxicillin/clavulanic acid combination in vitro, but the clinical efficacy of this combination has been demonstrated in the treatment of urinary tract infections caused by these strains

Amoxicillin is a broad-spectrum semi-synthetic antibiotic with activity against many Gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.

Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid has sufficient efficacy against plasmid beta-lactamases, which most often cause bacterial resistance, and is less effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid.

The presence of clavulanic acid in the preparation Augmentin® protects amoxicillin from destruction by beta — lactamase enzymes, which allows you to expand the antibacterial spectrum of amoxicillin.

Delayed release of amoxicillin in Augmentin® CP allows you to maintain the sensitivity of those strains of S. pneumoniae in which resistance to amoxicillin is due to penicillin-binding proteins (penicillin-resistant S. pneumoniae, or PRSP).

Below is the activity of the combination of amoxicillin with clavulanic acid in vitro.

Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid

Gram-positive airbags: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pneumoniae1,2, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Viridans group streptococci2, Streptococcus spp. (other beta-hemolytic streptococci)1,2, Staphylococcus aureus (sensitive to methicillin)1, Staphylococcus saprophyticus (methicillin-sensitive), coagulase-negative staphylococci (methicillin-sensitive).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: Clostridium spp., Peptostreptococcus spp., including Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros.

Gram-negative anaerobes: Bacteroides spp., including Bacteroides fragilis, Capnocytophaga spp., Eikenella corrodens, Fusobacterium spp., including Fusobacterium nucleatum, Porphyromonas spp., Prevotella spp.

Bacteria that are likely to have acquired resistance to the combination of amoxicillin with clavulanic acid

Gram-negative aerobes: Escherichia coli1, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae1, Proteus spp., including Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp.

Gram-positive airbags: Corynebacterium spp., Enterococcus faecium.

Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid

Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia, Yersinia enterocolitica.

Other: Chlamydia spp., including Chlamydia pneumoniae, Chlamydia psittaci, Coxiella burnetii, Mycoplasma spp.

¹ Для данных видов микроорганизмов клиническая эффективность комбинации амоксициллина с клавулановой кислотой была продемонстрирована в клинических исследованиях.

² Штаммы этих видов бактерий не продуцируют бета-лактамазы. Чувствительность при монотерапии амоксициллином позволяет предполагать аналогичную чувствительность к комбинации амоксициллина с клавулановой кислотой.

Resistance

Cross-resistance. Амоксициллин непосредственно демонстрирует перекрестную резистентность с другими бета-лактамными антибиотиками, а также комбинацией бета-лактамных антибиотиков с ингибиторами бета-лактамаз и цефалоспоринами.

Mechanisms of resistance. Клавулановая кислота защищает амоксициллин от разрушающего действия бета-лактамаз. Замедленное высвобождение действующих веществ препарата Аугментин^® СР повышает эффективность амоксициллина в отношении микроорганизмов, резистентность которых обусловлена модификацией пенициллинсвязывающих белков.

Bactericidal against a wide range of gram-positive and gram-negative microorganisms, aerobic and anaerobic pathogens (including those strains that have developed resistance to beta-lactam antibiotics due to the production of beta-lactamases).

Active against aerobic gram-positive bacteria (including beta-lactamase-producing strains): Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes

Clavulanic acid suppresses types II, III, IV and V of beta-lactamases, is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropicity to penicillinases and forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Pharmacokinetic properties

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The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid are well soluble in aqueous solutions with a physiological pH value and after taking the drug Amoxiclav® inside are quickly and completely absorbed from the gastrointestinal tract. The absorption of the active substances-amoxicillin and clavulanic acid-is optimal in the case of taking the drug at the beginning of a meal. The bioavailability of amoxicillin and clavulanic acid after oral administration is about 70%. Peak plasma concentrations are reached approximately 1 h after administration. The Cmax values for amoxicillin (depending on the dose) are 3-12 mcg/ml, for clavulanic acid — about 2 mcg/ml. Cmax in blood plasma after bolus injection at a dose of 1.2 g (1000-200 mg) of the drug is 105.4 mg/l - for amoxicillin and 28.5 mg/l - for clavulanic acid. When using Amoxiclav®, the plasma concentrations of amoxicillin/clavulanic acid are similar to those of oral administration of the corresponding doses of amoxicillin or clavulanic acid separately in equivalent doses. Both components are characterized by sufficient Vd in various organs, tissues and body fluids (in t.tsch. in the lungs, abdominal organs. Plasma protein binding is moderate-25% for clavulanic acid and 18% for amoxicillin. Vd is approximately 0.3–0.4 l / kg for amoxicillin and approximately 0.2 l / kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier in non-inflamed meninges. Amoxicillin (like most penicillins) is excreted in breast milk. Trace amounts of clavulanic acid were also found in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier. Amoxicillin is mainly excreted by the kidneys, whereas clavulanic acid is excreted by both the renal and extrarenal mechanisms. After a single oral administration of one tablet 250 125 mg or 500 125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine for the first 6 hours. About 10-25% of the initial dose of amoxicillin is excreted in the urine as inactive penicillic acid. Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4 - (2-hydroxyethyl) - 5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-one and is excreted in the urine and feces. The average T1 / 2 of amoxicillin/clavulanic acid is approximately 1 h, the average total clearance is approximately 25 l / h in healthy patients. In the course of various studies, it was found that the excretion of amoxicillin in the urine for 24 hours is approximately 50-85%, clavulanic acid-27-60%. The greatest amount of clavulanic acid is excreted within the first 2 hours after ingestion. The pharmacokinetic parameters of amoxicillin and clavulanic acid are summarized in Table 1. Table 1 Average (±SD) pharmacokinetic parameters Active substances Amoxicillin/clavulanic acid Dose, mg Cmax, mcg / ml Tmax, h AUC (0-24), mcg * h / ml T1/2, h Amoxicillin 875 mg/125 mg 875 11,64±2,78 1,5 (1-2,5) 53,52±12,31 1,19±0,21 500 mg/125 mg 500 7,19±2,26 1,5 (1-2,5) 53,52±8,37 1,15±0,2 Clavulanic acid 875 mg/125 mg 125 2,18±0,99 1,25 (1-2) 10,16±3,04 0,96±0,12 500 mg/125 mg 125 2,4±0,83 1,5 (1-2) 15,52±3,86 0,98±0,12 Patients with impaired liver function In patients with severe renal insufficiency, T1 / 2 increases to 7.5 h for amoxicillin and to 4.5 h for clavulanic acid. For patients with impaired liver function, the dose of the drug should be selected with caution: constant monitoring of the liver condition is necessary. Both components are removed by hemodialysis and minor amounts are removed by peritoneal dialysis

Suction

Both active ingredients of the drug Augmentin ® CP, amoxicillin and clavulanic acid, are well soluble in aqueous solutions with a physiological pH value, are quickly and completely absorbed from the gastrointestinal tract after oral administration. The absorption of active substances is optimal in the case of taking the drug at the beginning of a meal.

The pharmacokinetic parameters of amoxicillin and clavulanic acid after taking 2 tablets of the drug Augmentin are shown below® CP by healthy volunteers at the beginning of a meal.

Table 1

Average values of pharmacokinetic parameters

Drug Dose, mg T>MPC1, h (%) 2 Cmax, mg / l Tmax, h AUC, mcg * h/ml T1/2, h

Amoxicillin
31.12.1899 4: 01: 00 1000 mg 62.5 mg×2	2000	5,9 (49,4)	17	1,5	71,6	1,27
Clavulanic acid
31.12.1899 4: 01: 00 1000 mg 62.5 mg×2	125	Not defined	2,05	1,03	5,29	1,03

¹ Для бактерий с МПК 4 мг/л.

² Т>МПК, ч (%) — время (в процентах от временного интервала между дозами), в течение которого концентрация препарата в крови выше МПК для конкретного возбудителя.

The drug Augmentin® CP has a unique pharmacological profile, the T>MPC index characteristic of this drug is not achieved when taking tablets with immediate release of active substances containing a combination of amoxicillin and clavulanic acid.

Distribution

As with the intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are created in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluid, bile, purulent discharge).

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma binds to plasma proteins.

In animal studies, no accumulation of the components of the drug Augmentin was found® CP in any body.

Amoxicillin, like most penicillins, can be detected in breast milk. Trace amounts of clavulanic acid were also found in breast milk. With the exception of the possibility of diarrhea and candidiasis of the oral mucosa, no other negative effects of amoxicillin and clavulanic acid on the health of infants fed with breast milk are known.

Studies of reproductive function in animals when taking the drug Augmentin® CP showed that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no negative effect on the fetus.

Metabolism

10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid undergoes intensive metabolism to 2,5-dihydro-4 - (2-hydroxyethyl) - 5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-one and is excreted by the kidneys, through the gastrointestinal tract, and with exhaled air in the form of carbon dioxide.

Output

Like other penicillins, amoxicillin is mainly excreted by the kidneys, while clavulanic acid is excreted through both the renal and extrarenal mechanisms.

Studies have shown that, on average, about 60-70% of amoxicillin and about 40-65% of clavulanic acid is excreted unchanged by the kidneys.

Simultaneous administration of probenecid slows the elimination of amoxicillin, but does not slow the elimination of clavulanic acid (see "Interaction").

The pharmacokinetics of amoxicillin and clavulanic acid are similar. After intravenous administration at doses of 1200 mg and 600 mg, the Cmax of amoxicillin was 105.4 mcg / ml and 32.2 mcg/ml, respectively, and clavulanic acid was 28.5 mcg/ml and 10.5 mcg / ml, respectively. The connection with plasma proteins: amoxicillin — 17-20%, clavulanic acid — 23-30%. Both components are metabolized in the liver: amoxicillin - 10% of the administered dose, clavulanic acid-50%. T1 / 2 after intravenous administration at a dose of 1.2 g and 600 mg — 0.9 and 1.07 hours for amoxicillin, 0.9 and 1.12 hours-for clavulanic acid, respectively. It is mainly excreted by the kidneys (glomerular filtration and tubular secretion): 50-78% and 25-40% of the dose of amoxicillin and clavulanic acid, respectively, is excreted unchanged during the first 6 hours after administration

Pharmacotherapeutic group

Penicillins in combinations

Incompatibilities

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For all dosage forms Antacids, glucosamine, laxatives, drugs, aminoglycosides slow down the absorption of ascorbic acid increases the absorption. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion (probenecid) increase the concentration of amoxicillin (clavulanic acid is mainly excreted by glomerular filtration). Concomitant use of Amoxiclav® and methotrexate increases the toxicity of methotrexate. Administration together with allopurinol increases the frequency of exanthema. Concomitant use with disulfiram should be avoided. Reduces the effect of drugs, in the process of metabolism that produce PABA. The literature describes rare cases of increased INR in patients with the combined use of acenocumarol or warfarin and amoxicillin. If concomitant use with anticoagulants is necessary, PV or INR should be carefully monitored when prescribing or discontinuing the drug. The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides because of the possible decrease in the effectiveness of the drug Amoxiclav®. Amoxiclav ® reduces the effectiveness of oral contraceptives. For dispersible tablets and powder for preparation of suspension for oral administration, it additionally increases the effectiveness of indirect anticoagulants (by suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). In some cases, taking the drug may prolong the PV, in this regard, caution should be exercised when using anticoagulants and Amoxiclav®simultaneouslyQuicktab. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. In patients receiving mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, there was a decrease in the concentration of the active metabolite-mycophenolic acid, before taking the next dose of the drug by about 50%. Changes in this concentration may not accurately reflect the overall changes in mycophenolic acid exposure. For the powder for the preparation of a solution for intravenous administration, the drug Amoxiclav® and aminoglycoside antibiotics are chemically incompatible. Do not mix Amoxiclav® in a syringe or infusion bottle with other drugs. Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate, as well as with solutions containing blood, proteins, lipids

Simultaneous use of the drug Augmentin® CP and probenecid are not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Augmentin® CP and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid.

Concomitant use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.

Penicillins are able to slow the elimination of methotrexate from the body by inhibiting its tubular secretion, so the simultaneous use of the drug Augmentin® CP and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, the drug Augmentin® CP can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of increased MHO in patients with the combined use of acenocumarol or warfarin and amoxicillin. If necessary, simultaneous administration or withdrawal of the drug Augmentin® CP with PV or MHO anticoagulants should be carefully monitored, and the dose of anticoagulants for oral administration may need to be adjusted.

Pharmacologically incompatible with solutions containing blood, proteins, lipids, glucose, dextran, bicarbonate

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