Meronem time. for solution for infection. 1000 mg fl. No. 10

Powder for solution for injections Meronem is shown for treatment of such infections at adults and children aged from 3 months:

• pneumonia, including community-acquired and hospital pneumonia;
• bronchopulmonary infections in a mucoviscidosis;
• complicated infections of urinary tract
• complicated intraabdominal infections;
• infections during childbirth and postnatal infections;
• complicated infections of skin and soft tissues;
• acute bacterial meningitis.

Meronem can be applied to treatment of patients with a neutropenia and fever at suspicion on the fact that it is caused by a bacterial infection.

with any of the infections stated above.

Structure

Active ingredient - meropenem (1 bottle supports a meropenem trihydrate of 1140 mg (1000 mg of a meropenem anhydrous are equivalent)).

Excipient - sodium a carbonate anhydrous.

Contraindication

• hypersensitivity to active ingredient or to any of medicament excipients;
• hypersensitivity to any other antibacterial agent of group of karbapenem;
• heavy hypersensitivity (for example anaphylactic reactions, heavy skin reactions) to any other type beta laktamnogo antibacterial agent (for example to penicillin or cephalosporins).

Route of administration

data Given below contain the general recommendations about a medicament dosage.

Dose of a meropenem and duration of treatment depends on a type of a disease-producing factor, disease severity and the response to treatment.

Meronem at use in a dose up to 2 three times a day at adults and children with body weight more than 50 kg and in a dose to 40 mg/kg three times a day at children can be especially reasonable at treatment of some types of the infections caused by less sensitive species of bacteria (for example, types of Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter), or in very heavy infections.

needs to observe additional recommendations about a dosage at treatment of patients with a renal failure.

Adult and children with body weight more than 50 kg

Recommended doses for adults and children with body weight more than 50 kg (a dose for introduction each 8 hours):

• pneumonia, including community-acquired and hospital pneumonia - 500 mg or 1 g;
• bronchopulmonary infections in a mucoviscidosis - 2 g;
• complicated infections of urinary tract - 500 mg or 1 g;
• complicated intraabdominal infections - 500 mg or 1 g;
• an infection during childbirth and postnatal infections - 500 mg or 1 g;
• complicated infections of skin and soft tissues - 500 mg or 1 g;
• acute bacterial meningitis - 2 g;
• treatment of patients with a febrile neutropenia - 1 g

Meronem usually should be applied in the form of infusion lasting from 15 up to 30 minutes.

Besides, doses preparatado 1 it is possible to enter in the form of a bolyusny injection within 5 minutes. The data on safety confirming administration of medicament by the adult in a dose of 2 g in the form of a bolyusny injection are limited.

Children

Are not present data on safety and efficiency of a meropenem at children aged up to 3 months, and the optimum mode of dosing is not set. There are limited pharmacokinetic data proving use of a dose of a meropenem of 20 mg/kg each 8 hours.

Recommended doses for children aged from 3 months up to 11 years and with body weight to 50 kg (a dose for introduction each 8 hours):

• pneumonia, including community-acquired and hospital pneumonia - 10 or 20 mg/kg of body weight;
• bronchopulmonary infections in a mucoviscidosis - 40 mg/kg of body weight;
• complicated infections of urinary tract - 10 or 20 mg/kg of body weight;
• complicated intraabdominal infections - 10 or 20 mg/kg of body weight;
• complicated infections of skin and soft tissues - 10 or 20 mg/kg of body weight;
• acute bacterial meningitis - 40 mg/kg of body weight;
• treatment of patients with a febrile neutropenia - 20 mg/kg of body weight.

Children with body weight more than 50 kg: it is necessary to apply a dose, as to adult patients.

Way of use

Meronem usually should be applied in the form of infusion lasting from 15 to 30-t minutes. Besides, doses of a meropenem to 20 mg/kg can be entered in the form of a bolyusny injection within 5 minutes. The data on safety confirming introduction to children of medicament in a dose of 40 mg/kg in the form of a bolyusny injection are limited.

Solution should be stirred up before use.

Any unused product or waste needs to be utilized according to local requirements.

Feature of use

Pregnant

as a precautionary measure it is desirable for p to avoid use of a meropenem during pregnancy.

It was reported that a small amount of a meropenem gets into breast milk. Meronem it is possible to apply at a lactation only in cases if the expected advantage for mother exceeds potential risk for the child.

Drivers

did not conduct the Research of influence of medicament on ability to run vehicles and to work with mechanisms. At control of motor transport or other mechanisms it is recommended to observe extra care, considering a possibility of development of a headache, paresthesia or spasms about which it was reported at use of a meropenem.

Relative overdose is possible

at patients with a renal failure if the dose is not adjusted. Limited experience of post-marketing use of medicament indicates that if after overdose there are undesirable reactions, they will be coordinated with a profile of the specified side reactions described in the section "Side effects" and, as a rule, lungs on weight of manifestation and pass after medicament withdrawal or decrease in its dose. It is necessary to consider need of symptomatic treatment.

persons to normal function of kidneys have a fast removal of medicament kidneys.

Hemodialysis brings

meropeny and its metabolites out of an organism.

Side effects

during survey of data of 4872 of 5026 patients on influence of treatment of a meropenem the most frequent undesirable reactions connected with use of a meropenem were diarrhea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and inflammation in the injection site of an injection (1.1%). The thrombocytosis (1.6%) and increase in level of liver enzymes (1.5-4.3%) were the most frequent undesirable, connected using a meropenem phenomena from laboratory indicators about which it was reported.

to Store

at a temperature not above 30 °C, out of children's reach. Not to freeze.

Each bottle is intended to

only for single use.

At preparation of solution and during its use should use standard aseptic methods of work.

Expiration date - 4 years.