Mepenam powder for solution for injection is indicated for the treatment of the following infections in adults and children from 3 months of age:
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.
Mepenam can be used to treat patients with neutropenia and fever if a bacterial infection is suspected.
Composition
The active substance is meropenem (1 vial contains meropenem trihydrate equivalent to meropenem - 1.0 g).
The excipient is sodium carbonate anhydrous.
Contraindication
Hypersensitivity to the active substance and/or to any of the excipients of the drug, and/or hypersensitivity to any other antibacterial agent of the carbapenem group; severe hypersensitivity (e.g. anaphylactic reaction, severe skin reactions) to any other type of beta-lactam antibacterial agent (e.g. penicillins or cephalosporins).
Method of application
The following information provides general recommendations for dosing of the drug.
The dose of meropenem and the duration of treatment depend on the type of pathogen, the severity of the disease and the individual sensitivity of the patient.
Meropenem, when used at a dose of up to 2 g three times a day in adults and children weighing more than 50 kg and at a dose of up to 40 mg/kg three times a day in children, may be particularly suitable for the treatment of certain types of infections, such as nosocomial infections caused by Pseudomonas aeruginosa or Acinetobacter spp.
Recommended doses for adults and children weighing more than 50 kg (single dose to be administered every 8 hours):
pneumonia, including community-acquired and hospital-acquired pneumonia - 500 mg or 1 g; bronchopulmonary infections in cystic fibrosis - 2 g; complicated urinary tract infections - 500 mg or 1 g; complicated intra-abdominal infections - 500 mg or 1 g; infections during childbirth and postpartum infections - 500 mg or 1 g; complicated skin and soft tissue infections - 500 mg or 1 g; acute bacterial meningitis - 2 g; treatment of patients with febrile neutropenia - 1 g
Mepenam should usually be administered as an intravenous infusion lasting 15 to 30 minutes.
Additionally, doses up to and including 1 g can be administered as an intravenous bolus injection over approximately 5 minutes. There are limited safety data supporting the administration of 2 g as an intravenous bolus injection in adults.
Performing an intravenous bolus injection
The solution for bolus injection should be prepared by dissolving the drug "Mepenam" in water for injection to obtain a concentration of 50 mg/ml (20 ml per 1 g of meropenem).
Chemical and physical in-use stability of the reconstituted solution for bolus injection has been demonstrated for 3 hours at room temperature (15-25°C). However, from a microbiological point of view, the product should be used immediately.
If the medicine is not used immediately, the doctor is responsible for the period and conditions of its storage after preparation.
Infusion
The infusion solution should be prepared by dissolving the drug "Mepenam" in 0.9% sodium chloride solution for infusions or in 5% glucose (dextrose) solution for infusions to obtain a concentration of 1-20 mg/ml.
The chemical and physical stability of the prepared solution for infusion using 0.9% sodium chloride solution is maintained for 6 hours at room temperature (15-25 °C) or for 24 hours at 2-8 °C. The prepared solution, if refrigerated, should be used within 2 hours after storage in a refrigerator. From a microbiological point of view, the medicinal product should be used immediately. If the medicinal product is not used immediately, the duration and conditions of its storage after preparation are the responsibility of the physician.
Mepenam solution prepared with 5% glucose (dextrose) solution should be used immediately, i.e. within one hour after preparation.
Each vial is intended for single use only.
Standard aseptic techniques should be used when preparing the solution and during its administration.
The solution should be shaken before use.
It is recommended to use freshly prepared solutions.
Application features
Pregnant women
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
It is not known whether meropenem is excreted in human milk. Meropenem is found in very low concentrations in the breast milk of animals. A decision should be made whether to discontinue breast-feeding or to discontinue meropenem therapy, taking into account the benefit of therapy for the woman.
Drivers
Studies of the effect of the drug on the ability to drive vehicles and operate machinery have not been conducted, but possible adverse reactions from the nervous system should be taken into account.
Relative overdose is possible in patients with impaired renal function if the dose of the drug is not adjusted. If adverse reactions occur after overdose, they are consistent with the profile of the specified adverse reactions, and, as a rule, are mild in severity and resolve after discontinuation of the drug or reduction in its dose. The need for 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
Common adverse reactions associated with the use of meropenem were diarrhea, rash, nausea/vomiting and injection site inflammation, thrombocytosis and elevated liver enzymes.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.
Shelf life - 3 years.
