Meropenem 1 g powder for solution for injection or infusion Summary of Product Characteristics SmPC emc

Meropenem 1 g powder for solution for injection or infusion Summary of Product Characteristics SmPC emc

As a precautionary measure, it is preferable to avoid the use of meropenem during pregnancy. No specific medicinal product interaction studies other than probenecid were conducted. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).

  • Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite.
  • The sole metabolite of meropenem had a similar profile of toxicity in animal studies.
  • Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes.

In recent years, infection caused by drug-resistant bacteria has become a serious public health problem. The exploration of antibacterial therapies other than antibiotics has attracted more and more attention. Photothermal therapy (PTT) has become a promising antibacterial method due to its low invasiveness, low toxicity and avoidance of drug-resistant bacteria. However, when PTT is used alone, it requires a higher temperature to achieve a better antibacterial effect, which will not only kill bacteria, but also cause damage to normal tissues, and even trigger new inflammation.

Meropenem 1 g powder for solution for injection or infusion

Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8). If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below.

  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
  • Pharmacokinetic studies performed in patients have not shown significant pharmacokinetic differences versus healthy subjects with equivalent renal function.
  • No specific medicinal product interaction studies other than probenecid were conducted.
  • From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
  • The required dose should be administered after completion of the haemodialysis cycle.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. A solution for infusion is prepared by dissolving the drug product meropenem in either 0.9% sodium chloride solution for infusion or 5% glucose (dextrose) solution for infusion to a final concentration of 1 to 20 mg/ml. A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. In healthy subjects the mean plasma half-life is approximately 1 hour; the mean volume of distribution is approximately 0.25 l/kg (11-27 l) and the mean clearance is 287 ml/min at 250 mg falling to 205 ml/min at 2 g. Doses of 500, 1000 and 2000 mg doses infused over 30 minutes give mean Cmax values of approximately 23, 49 and 115 μg/ml respectively, corresponding AUC values were 39.3, 62.3 and 153 μg.h/ml.

Databases

Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). No studies on the effect on the ability to drive and use machines have been performed. However, when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem. Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. The maximum daily dose of this product is equivalent to ≥27% of the WHO recommended maximum daily intake for sodium. A positive direct or indirect Coombs test may develop during treatment with meropenem.

  • A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses.
  • The remaining challenges and future opportunities in this field are also highlighted.
  • After infusion over 5 minutes Cmax values are 52 and 112 μg/ml after 500 and 1000 mg doses respectively.
  • The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.

A study in patients with alcoholic cirrhosis shows no effect of liver disease on the pharmacokinetics of meropenem after repeated doses. A study of 12 patients administered meropenem 1000 mg 8 hourly post-surgically for intra-abdominal infections showed a comparable Cmax and half-life to normal subjects but a greater volume of distribution 27 l. Relative overdose may be possible in patients with renal impairment if the dose is not adjusted as described in section 4.2. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated up to 3 hours at controlled room temperature (15-25°C) or up to 8 hours under refrigerated conditions (2-8°C). From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

Databases

However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s). Localised clusters of infections due to carbapenem-resistant bacteria have been reported in the European Union. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. There are no or limited amount of data from the use of meropenem in pregnant women.

Meropenem 1 g powder for solution for injection or infusion

Meropenem is primarily excreted unchanged by the kidneys; approximately 70 % (50 –75 %) of the dose is excreted unchanged within 12 hours. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. Meropenem is metabolised by hydrolysis of the beta-lactam ring generating a microbiologically inactive metabolite.

There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see https://store365.net/2023/12/20/uk-s-top-rated-steroid-suppliers-unveiling-the/ section 5.2). The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. Histological evidence of renal tubular damage was seen in mice and dogs only at doses of 2000 mg/kg and above after a single administration and above and in monkeys at 500 mg/kg in a 7-day study.

Databases

There are limited data to support the administration of these dose adjustments for a unit dose of 2 g. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection.

Deja una respuesta