Aris (meropenem) powder for infusions 1g. vial №1

Aris (meropenem) powder for infusions 1g. vial №1

$56.30

Manufacturer: India

Indicated for the treatment of such infections in adults and children over 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 infections of the skin and soft tissues;
  • acute bacterial meningitis.

Can be used to treat patients with neutropenia and fever when a bacterial infection is suspected.

Consideration should be given to providing formal guidance on the appropriate use of antibacterial agents.

Category:

Description

Ingredients

active ingredient: meropenem;

1 vial contains: meropenem trihydrate equivalent to meropenem 1000 mg;

excipients : sodium carbonate anhydrous.

Dosage form

Powder for solution for infusion.

Basic physical and chemical properties : powder from white to light yellow.

Pharmacotherapeutic group

Antimicrobial agents for systemic use. Carbapenems. ATX code J01D H02.

Pharmacodynamics

Meropenem exerts its bactericidal action by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria by binding to penicillin-binding proteins (PBPs).

As with other beta-lactam antibacterial agents, the times at which meropenem concentrations exceeded minimum inhibitory concentrations (MICs) (T>MIS) indicated a high degree of correlation with efficacy. There is evidence that, in the preclinical phase, meropenem has demonstrated activity at plasma concentrations in excess of the MIS for infecting organisms by about 40% of the dosing interval. This target value has not been established clinically.

Bacterial resistance to meropenem may result from: decreased outer membrane permeability of Gram-negative bacteria (due to decreased production of Plunge), decreased affinity to target PBPs, increased expression of efflux pump components, and production of beta-lactamases that can hydrolyze carbapenems.

Cases of infectious diseases caused by bacteria resistant to carbapenems have been reported.

There is no cross-resistance between meropenem and drugs belonging to the classes of quinolones, aminoglycosides, macrolides and tetracyclines, taking into account the target microorganisms. However, bacteria can show resistance to more than one class of antibacterial drugs when the mechanism involved involves impermeability of the cell membrane or the presence of the efflux pump(s).

MIS cut-off values ​​that have been determined in clinical trials by the European Committee for Antimicrobial Susceptibility Testing (EUCAST) are shown below.

Table 1

Microorganism Sensitive (S), (mg/l) Resistant (R), (mg/l)
Enterobacteriaceae ≤ 2 > 8
Pseudomonas ≤ 2 > 8
Acinetobacter ≤ 2 > 8
Streptococcus, groups A, B, C, G ≤ 2 > 2
Streptococcus pneumoniae 1  ≤ 2 > 2
Other streptococci 2 2
Enterococcus – –
Staphylococcus2 note 3  note 3
Haemophilus influenzae 1 and Moraxella catarrhalis ≤ 2 > 2
Neisseria meningitidis 2.4 ≤ 0.25  > 0.25
Gram-positive anaerobes  ≤ 2 > 8
Gram-negative anaerobes ≤ 2 > 8
Limit values ​​not related to microorganism species 5  ≤ 2 > 8

 

1 – limit value of meropenem for Streptococcus pneumoniae and Haemophilus influenzae in meningitis is 0.25/l mg/l.

2 – Microorganism strains with MIS values ​​above the S/I limit values ​​are very rare or not currently reported. Identification and antimicrobial susceptibility tests for any such isolate should be repeated and, if the result is confirmed, the isolate is sent to the reference laboratory. By the time the clinical response data of verified MIS isolates is above the current resistance limits, the isolates should be reported as resistant.

3 – Staphylococcal susceptibility to meropenem is predicted from methicillin susceptibility data.

4 – Meropenem limit values ​​for Neisseria meningitidis apply only to meningitis.

5 – limit values ​​not associated with microbial species, were determined mainly on the basis of PK / PD data and do not depend on the distribution of MIS of individual species. They are intended for use with species not listed in the table and footnotes.

Susceptibility testing is not recommended as the species is a poor target for drug treatment.

The prevalence of acquired resistance may vary geographically and over time for individual species, so it is desirable to rely on local information on microorganism resistance, especially when treating severe infections. If necessary, when the level of prevalence of resistance of microorganisms at the local level is such that the benefit of using the drug, at least in relation to certain types of infections, is in doubt, expert advice should be sought.

Pathogenic microorganisms are indicated below, taking into account clinical experience and therapeutic protocols for the treatment of diseases.

Indications

Indicated for the treatment of such infections in adults and children over 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 infections of the skin and soft tissues;
  • acute bacterial meningitis.

Can be used to treat patients with neutropenia and fever when a bacterial infection is suspected.

Consideration should be given to providing formal guidance on the appropriate use of antibacterial agents.

Contraindications

Hypersensitivity to the active substance and / or any of the excipients of the drug.

Hypersensitivity to any other antibacterial agent of the carbapenem group.

Severe hypersensitivity (eg, anaphylactic reactions, severe skin reactions) to any other type of beta-lactam antibacterial agent (eg, penicillin or cephalosporins).

Dosage and administration

The tables below contain general recommendations for the dosage of the drug.

The dose of Aris (meropenem) and the duration of treatment depends on the type of pathogen, the severity of the disease and the individual sensitivity of the patient.

Aris (meropenem) at doses up to 2 g three times a day in adults and children weighing more than 50 kg and at doses 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.

table 2

Recommended doses for adults and children weighing over 50 kg

Infection Dose to administer every 8 hours
Pneumonia, including community-acquired and nosocomial 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

Meropenem should usually be given as an infusion over 15 to 30 minutes.

In addition, doses up to 1 g can be given as a bolus injection over 5 minutes. There are limited safety data supporting the administration of the 2 g bolus injection in adults.

Impaired kidney function

Table 3

Recommended doses for adults and children weighing more than 50 kg if the patient’s creatinine clearance is less than 51 ml/min

QC (ml / min) dose (see Table 1) frequency
26-50 full once every 12 hours
10-25 half a single dose every 12 hours
<10 half a single dose every 24 hours

Data confirming the use of the doses of the drug indicated in Table 2, adjusted for a dose unit of 2 g, are limited.

Aris (meropenem) is eliminated by hemodialysis and hemofiltration, so the required dose of the drug should be administered after completion of the hemodialysis procedure.

There are no established dose recommendations for patients receiving peritoneal dialysis.

Impaired liver function

For patients with impaired liver function, dose adjustment of the drug is not required.

Dosing for Elderly Patients

For elderly patients with normal renal function or with creatinine clearance values ​​​​of 50 ml / min, dose adjustment is not required.

Children

Table 4

Recommended doses for children aged 3 months to 11 years and weighing up to 50 kg

Infection Dose to administer every 8 hours
Pneumonia, including community-acquired and hospital-acquired 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

There is no experience of using the drug in children with impaired renal function.

Aris (meropenem) should usually be given as an infusion, lasting from

15 to 30 minutes. Alternatively, doses of Aris (meropenem) up to 20 mg/kg may be given as a bolus injection over 5 minutes. There are limited safety data supporting the administration of 40 mg/kg as a bolus injection to children.

Children weighing over 50 kg

The dosage should be the same as for adult patients.

Administering a bolus injection

A solution for bolus injection should be prepared by dissolving the drug Aris in water for injection to obtain a concentration of 50 mg / ml.

The chemical and physical stability of the prepared solution for bolus injection was maintained for 3 hours at room temperature (15-25°C).

From a microbiological point of view, the drug must be used immediately.

If the medicinal product is not used immediately, the doctor is responsible for the period and conditions of its storage after preparation.

Conducting intravenous infusion

The solution for infusion should be prepared by dissolving the drug Aris in 0.9% sodium chloride solution for injection or 5% glucose (dextrose) solution for injection 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 was maintained for 6 hours at room temperature (15-25 ° C) or for 24 hours at a temperature of 2-8 ° C. The prepared solution, if has been refrigerated, should be used within 2 hours of storage in the refrigerator. From a microbiological point of view, the drug must be used immediately. If the medicinal product is not used immediately, the doctor is responsible for the period and conditions of its storage after preparation.

Aris (meropenem) solution prepared with 5% glucose (dextrose) solution should be used immediately, i.e. within 1 hour after preparation.

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