Powder for preparation of solution for infusions Sinerpen is indicated for the treatment of infections in adults and children over 1 year of age caused by microorganisms sensitive to the drug:
intra-abdominal infections; lower respiratory tract infections; intranatal and postpartum infections; complicated genitourinary infections; complicated skin and soft tissue infections; bone and joint infections; septicemia, endocarditis.
Composition
Active ingredients: imipenem and cilastatin sodium;
1 vial contains imipenem (sterile) 530.10 mg equivalent to anhydrous imipenem 500 mg cilastatin sodium salt (sterile) 530.70 mg equivalent to cilastatin 500 mg;
Excipients: sodium bicarbonate.
Contraindication
Hypersensitivity to the components of the drug, other carbapenem drugs, acute manifestations of hypersensitivity (e.g. anaphylactic reactions, severe skin reactions) to other ß-lactam antibiotics (e.g. penicillin and cephalosporins).
Method of application
Each vial is intended for single use only.
The contents of the vial (powder) must be dissolved and diluted appropriately before use. Each dose not exceeding 500 mg / 500 mg of the drug for intravenous use should be administered over 20-30 minutes. Each dose exceeding 500 mg / 500 mg should be administered over 40-60 minutes. If the patient experiences nausea during the infusion, the rate of administration of the drug should be reduced.
Application features
Pregnant women
It can be prescribed during pregnancy only if the expected benefit to the pregnant woman outweighs the potential risk to the fetus.
Children
The drug is not recommended for use in children under 1 year of age and children with impaired kidney function.
Drivers
Given the risk of side effects such as hallucinations, drowsiness, dizziness, driving and operating machinery should be avoided when using the drug.
Overdose
Symptoms of overdose that may occur are consistent with the adverse reaction profile; they may include convulsions, confusion, tremor, nausea, vomiting, hypotension, bradycardia.
There is no specific information on the treatment of overdose with the drug. The drug is removed by hemodialysis. However, the effectiveness of this procedure in overdose has not been established. Treatment is symptomatic.
Side effects
The most common systemic adverse reactions possibly related to imipenem/cilastatin treatment were nausea (2%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), convulsions (0.4%), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), and somnolence (0.2%).
The most common local adverse reactions were: phlebitis/thrombophlebitis (3.1%), injection site pain (0.7%), injection site erythema (0.4%), and vein induration (0.2%).
Interaction
Generalized seizures have been reported in patients receiving ganciclovir with intravenous imipenem/cilastatin. These drugs should only be used together if the expected benefit outweighs the potential risk.
Decreased plasma valproic acid levels have been reported with concomitant use with carbapenems, and in some cases sudden convulsions have been reported. Therefore, concomitant use of imipenem and valproic acid/sodium valproate is not recommended.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze.
Keep out of reach of children.
Shelf life - 2 years.
