MERONEM IV 1g Powder for solution for injection or infusion Ref.[7561] Active ingredients: Meropenem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Meronem IV 1g.

Pharmaceutical Form

Powder for solution for injection or infusion.

A white to light yellow powder.

Qualitative and quantitative composition

Meronem IV 1 g.

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

Excipients with known effect: Each 1 g vial contains 208 mg sodium carbonate which equates to approximately 4 mEq of sodium (approximately 90 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Meropenem

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).

List of Excipients

Meronem 1 g:

Anhydrous sodium carbonate

Pack sizes and marketing

Meronem 1 g: 1348 mg powder in a 30 ml Type 1 glass vial with stopper (grey halobutilic rubber with an aluminium cap).

The medicinal product is supplied in pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

Meronem 1 g: PL 00057/1536

09 February 2009

Drugs

Drug Countries
MERONEM Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Poland, Singapore, United Kingdom, South Africa

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