MEROPENEM Powder for solution for injection / infusion Ref.[51392] Active ingredients: Meropenem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Meropenem 1 g powder for solution for injection or infusion.

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.

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.

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

Sodium carbonate, anhydrous

Pack sizes and marketing

1349.56 mg powder in a 40ml Type-I, tubular, clear glass vial with stopper (bromobutyl rubber with aluminum seals having white colour polypropylene discs).

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

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0444

28/10/2020

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