Merobocid powder for solution for injection is indicated for the treatment of infections in adults and children aged 3 months and older:
pneumonia, including community-acquired and hospital-acquired pneumonia, bronchopulmonary infections in cystic fibrosis; complicated urinary tract infections; complicated intra-abdominal infections; infections during childbirth and postpartum infections; complicated skin and soft tissue infections; acute bacterial meningitis.
Composition
Active ingredient: meropenem;
1 vial contains meropenem trihydrate equivalent to meropenem anhydrous 1000 mg;
Excipients: sodium carbonate anhydrous.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to any other carbapenem antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reactions) to any other type of β-lactam antibacterial agent (e.g. penicillins or cephalosporins).
Method of application
The infusion solution should be prepared by dissolving the drug in 0.9% sodium chloride solution for injection or 5% glucose (dextrose) solution for injection to a concentration of 1-20 mg/ml.
Chemical and physical in-use stability of the reconstituted solution for infusion using 0.9% sodium chloride solution has been demonstrated for 6 hours at room temperature (15-25°C) or for 24 hours at 2-8°C. The reconstituted solution, if refrigerated, should be used within 2 hours of storage in a refrigerator. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions and shelf life of the product after reconstitution are the responsibility of the physician.
The solution prepared with 5% glucose (dextrose) solution should be used immediately, i.e. within 1 hour after preparation.
Application features
Pregnant women
Not recommended.
Children
The drug is used in children aged 3 months and older.
Drivers
Studies of the effect of the drug on the ability to drive vehicles or other mechanisms have not been conducted.
Overdose
Relative overdose is possible in patients with impaired renal function if the dose is not adjusted. Some post-marketing experience suggests that if adverse reactions occur after overdose, they are consistent with the profile of adverse reactions listed below, and are usually mild in severity and resolve after discontinuation of the drug or dose reduction. Symptomatic treatment should be considered.
In individuals with normal kidney function, the drug is rapidly excreted by the kidneys.
Hemodialysis removes meropenem and its metabolites from the body.
Side effects
Immune system: angioedema, anaphylactic reactions. Blood: thrombocytopenia, eosinophilia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia. Nervous system: headache, paresthesia, convulsions. Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain; colitis associated with the use of antibiotics. Digestive system: increased transaminase levels, increased alkaline phosphatase, lactate dehydrogenase and bilirubin in the blood. Skin: rash, itching, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme. Urinary system: increased creatinine and urea levels in the blood. General disorders and administration site conditions: inflammation, pain, thrombophlebitis, pain at the injection site.
Interaction
Concomitant use with carbapenems has been reported to decrease blood valproic acid levels by 60-100% within approximately 2 days. Due to the rapid onset of action and the extent of the decrease, concomitant use of valproic acid and carbapenems is considered uncorrectable and should be avoided.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging. Do not freeze.
Keep out of reach of children.
Shelf life - 2 years.
