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 Meronem For Injection (FEROWAY)  
 

QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Meronem IV 500 mg

Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.

Meronem IV 1 g

Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.

Excipients:

Each 500 mg vial contains 104 mg sodium carbonate which equates to approximately 2.0 mEq of sodium (approximately 45 mg).

Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4.0 mEq of sodium (approximately 90 mg).

For a full list of excipients, see section 6.1.

 



PHARMACEUTICAL FORM

 

Powder for solution for injection or infusion.

A white to light yellow powder.

 



Therapeutic indications

 

Meronem is indicated for the treatment of the following infections in adults and children over 3 months of age:

• Pneumonia, including community acquired pneumonia and nosocomial 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

Meronem 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

 

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.

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

Pneumonia including community-acquired pneumonia and nosocomial 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.

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.

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.

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

Pneumonia including community-acquired pneumonia and nosocomial 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. 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.

 

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