AXETINE Film-coated tablet Ref.[28133] Active ingredients: Cefuroxime

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Axetine 250 mg film-coated tablets.

Axetine 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

Axetine 250mg film-coated tablets: White, capsule shaped film-coated tablets, scored on one side, having a nucleus diameter of 14mm.

Axetine 500mg film-coated tablets: White, capsule shaped film-coated tablets, scored on one side, having a nucleus diameter of 19mm.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Axetine 250mg film-coated tablets contain 250mg cefuroxime as cefuroxime axetil.

Axetine 500mg film-coated tablets contain 500mg cefuroximeas cefuroxime axetil.

Excipient with known effect: propylene glycol.

For the full list of excipients see section 6.1.

Active Ingredient Description
Cefuroxime

Cefuroxime inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

List of Excipients

Microcrystaline cellulose 105
Colloidal anhydrous silica
Crosscarmellose sodium
Sodium lauryl sulphate
Hydrogenated vegetable oil
Hypromellose 2910
Propylene glycol
Titanium dioxide
Talc

Pack sizes and marketing

Axetine is packed in white opaque PVC/PVDC/Alu blisters, Alu-Alu strips and Alu-Alu blisters. Axetine 500mg film-coated tablets is also available in Alu /Alu blisters.

Available pack sizes are:

Blisters: 10 tablets, 14 tablets, 20 tablets, 30 tablets and 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Axetine 250mg film-coated tablets: 20762
Axetine 500mg film-coated tablets: 20763

29/09/2010

Drugs

Drug Countries
AXETINE Cyprus, Estonia, Hong Kong, Lithuania, Malta, Romania, Singapore

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