PRIMAXIN IV Powder for solution for infusion Ref.[10486] Active ingredients: Cilastatin Imipemide Imipenem and Cilastatin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Product name and form

PRIMAXIN IV 500 mg/500 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion.

White to light yellow powder.

Qualitative and quantitative composition

Each vial contains imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin.

Excipient with known effect: Each vial contains 37.6 mg (1.6 mmol) of sodium (as bicarbonate).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Cilastatin
Imipemide

Imipenem is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya. Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs).

Imipenem and Cilastatin

Imipenem, also referred to as N-formimidoyl-thienamycin, is a semi-synthetic derivative of thienamycin, the parent compound produced by the filamentous bacterium Streptomyces cattleya. Imipenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). Cilastatin sodium is a competitive, reversible and specific inhibitor of dehydropeptidase-I, the renal enzyme which metabolizes and inactivates imipenem. It is devoid of intrinsic antibacterial activity and does not affect the antibacterial activity of imipenem.

List of Excipients

Sodium bicarbonate

Pack sizes and marketing

20 ml Type I glass vials.

The medicinal product is supplied in packs of 1 vial, 10 vials and 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Marketing authorization dates and numbers

PL 53095/0006

Licence first granted: 30 June 1988
Licence last renewed: 8 March 2012

Drugs

Drug Countries
PRIMAXIN Canada, Ireland, Malta, United Kingdom, United States

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