Meronem powder for solution for injection is indicated for the treatment of the following 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.
Meronem can be used to treat patients with neutropenia and fever suspected to be caused by a bacterial infection.
Treatment of patients with bacteremia that is associated or may be associated with any of the above infections.
Composition
The active substance is meropenem (1 vial contains meropenem trihydrate 1140 mg (equivalent to 1000 mg of meropenem anhydrous)).
The excipient is sodium carbonate anhydrous.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug; 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 dosage recommendations.
The dose of meropenem and the duration of treatment depend on the type of pathogen, the severity of the disease and the response to treatment.
Meronem, 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 useful in the treatment of certain types of infections caused by less susceptible species of bacteria (e.g., Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter species), or in very severe infections.
Additional dosing recommendations should be followed when treating patients with renal insufficiency.
Adults and children weighing more than 50 kg
Recommended doses for adults and children weighing more than 50 kg (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
Meronem should usually be administered as an infusion lasting 15 to 30 minutes.
Alternatively, doses up to 1 g can be administered as a bolus injection over 5 minutes. There are limited safety data supporting the administration of 2 g as a bolus injection in adults.
Children
There are no data on the safety and efficacy of meropenem in children under 3 months of age, and the optimal dosage regimen has not been established. There are limited pharmacokinetic data to support the use of a dose of meropenem of 20 mg/kg every 8 hours.
Recommended doses for children aged 3 months to 11 years and weighing up to 50 kg (dose to be administered every 8 hours):
pneumonia, including community-acquired and hospital-acquired pneumonia - 10 or 20 mg/kg body weight; bronchopulmonary infections in cystic fibrosis - 40 mg/kg body weight; complicated urinary tract infections - 10 or 20 mg/kg body weight; complicated intra-abdominal infections - 10 or 20 mg/kg body weight; complicated skin and soft tissue infections - 10 or 20 mg/kg body weight; acute bacterial meningitis - 40 mg/kg body weight; treatment of patients with febrile neutropenia - 20 mg/kg body weight.
Children weighing more than 50 kg: the dose should be used as for adult patients.
Method of use
Meropenem should usually be administered as an infusion over 15 to 30 minutes. Alternatively, doses of meropenem up to 20 mg/kg may be administered as a bolus injection over 5 minutes. There are limited safety data supporting the use of 40 mg/kg bolus injection in children.
The solution should be shaken before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
Application features
Pregnant women
As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy.
It has been reported that small amounts of meropenem pass into breast milk. Meronem should be used during lactation only if the expected benefit to the mother outweighs the potential risk to the child.
Drivers
No studies on the effects of the drug on the ability to drive and use machines have been conducted. It is recommended to exercise special caution when driving or operating machinery, given the possibility of developing headache, paresthesia or seizures, which have been reported with the use of meropenem.
Relative overdose is possible in patients with impaired renal function if the dose is not adjusted. Limited post-marketing experience indicates that if adverse reactions occur after overdose, they are consistent with the profile of these adverse reactions described in the "Adverse Reactions" section and are usually 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
In a review of 4872 of 5026 patients exposed to meropenem, the most common adverse reactions associated with meropenem were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%), and injection site inflammation (1.1%). The most common laboratory adverse reactions associated with meropenem were thrombocytosis (1.6%) and increased liver enzymes (1.5-4.3%).
Storage conditions
Store at a temperature not exceeding 30 °C, out of the reach of children. Do not freeze.
Each vial is intended for single use only.
Standard aseptic techniques should be used when preparing the solution and during its administration.
Shelf life - 4 years.
