ARCHIFAR Powder for solution for injection / infusion Ref.[28180] Active ingredients: Meropenem

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Archifar 500 mg powder for solution for injection or infusion.

Archifar 1g powder for solution for injection or infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

A white to light yellow crystalline powder.

Qualitative and quantitative composition

Each vial contains meropenem trihydrate equivalent to anhydrous meropenem 500mg and 1g, respectively.

Excipient with known effect: sodium.

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 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

Pack sizes and marketing

Type I clear glass vials of 20ml and 30ml. Packs of 1, 10, 25, 50 and 100 vials are available.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

500mg: 20809
1g: 20810

500mg: 23/11/2010
1g: 24/11/2010

Drugs

Drug Countries
ARCHIFAR Cyprus, Spain, Croatia, Malta, Romania, Singapore, Tunisia

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