Qualitative and quantitative composition
Each vial of powder for solution for injection or infusion contains 1141.56 mg meropenem trihydrate equivalent to 1 g anhydrous meropenem.
Excipients with known effect: Each vial contains 208 mg sodium carbonate approximately 4.0 mmol of sodium (approximately 90 mg).
Each ml of reconstituted solution contains 50 mg Meropenem.
For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection or infusion.
A White to pale yellow crystalline powder.
pH of the product after reconstitution is 7.3 to 8.3
Clinical particulars
Therapeutic indications
Meropenem is indicated for the treatment of the following infections in adults and children over 3 months of age (see sections 4.4 and 5.1):
• Severe pneumonia, including hospital and ventilator-associated pneumonia.
• Broncho-pulmonary infections in cystic fibrosis
• Complicated urinary tract infections
• Complicated intra-abdominal infections
• Intra- and post-partum infections
• Complicated skin and soft tissue infections
• Acute bacterial meningitis
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Posology
The tables below provide general recommendations for dosing.
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 dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.) or very severe infections.
Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).
Adults and adolescents
|
Infection |
Dose to be administered every 8 hours |
|
Severe pneumonia including hospital and ventilator-associated pneumonia. |
500 mg or 1 g |
|
Broncho-pulmonary infections in cystic fibrosis |
2 g |
|
Complicated urinary tract infections |
500 mg or 1 g |
|
Complicated intra-abdominal infections |
500 mg or 1 g |
|
Intra- and post-partum infections |
500 mg or 1 g |
|
Complicated skin and soft tissue infections |
500 mg or 1 g |
|
Acute bacterial meningitis |
2 g |
|
Management of febrile neutropenic patients |
1 g |
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see section 6.2, 6.3 and 6.6).
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.
Renal impairment
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the application of these dose adjustments for a unit dose of 2 g.
|
Creatinine clearance (ml/min) |
Dose
(based on “unit” dose range of 500 mg or 1 g or 2 g, see table above) |
Frequency |
|
26-50 |
one unit dose |
every 12 hours |
|
10-25 |
half of one unit dose |
every 12 hours |
|
<10 |
half of one unit dose |
every 24 hours |
Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
Hepatic impairment
No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Dose in elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Paediatric population
Children under 3 months of age
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 section 5.2).
Children from 3 months to 11 years of age and up to 50 kg body weight
The recommended dose regimens are shown in the table below:
|
Infection |
Dose to be administered every 8 hours |
|
Severe pneumonia including hospital and ventilator-associated pneumonia |
10 or 20 mg/kg |
|
Broncho-pulmonary infections in cystic fibrosis |
40 mg/kg |
|
Complicated urinary tract infections |
10 or 20 mg/kg |
|
Complicated intra-abdominal infections |
10 or 20 mg/kg |
|
Complicated skin and soft tissue infections |
10 or 20 mg/kg |
|
Acute bacterial meningitis |
40 mg/kg |
|
Management of febrile neutropenic patients |
20 mg/kg |
Children over 50 kg body weight
The adult dose should be administered.
There is no experience in children with renal impairment.
Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.
Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion in vial.
Product after reconstitution is clear colourless to yellow solution. |
