MEDAXONUM Powder for solution for injection/infusion Ref.[28308] Active ingredients: Ceftriaxone

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

Product name and form

Medaxonum, 250 mg, powder for solution for injection/infusion.
Medaxonum, 500 mg, powder for solution for injection/infusion.
Medaxonum, 1 g, powder for solution for injection/infusion.
Medaxonum, 2 g, powder for solution for injection/infusion.

Pharmaceutical Form

Powder for solution for injection/infusion.

Almost white or yellowish crystalline powder.

Qualitative and quantitative composition

Medaxonum 250 mg vials contain 250 mg ceftriaxone as hydrated ceftriaxone disodium.
Medaxonum 500 mg vials contain 500 mg ceftriaxone as hydrated ceftriaxone disodium.
Medaxonum1 g vials contain 1 g ceftriaxone as hydrated ceftriaxone disodium.
Medaxonum 2 g vials contain 2 g ceftriaxone as hydrated ceftriaxone disodium.

Active Ingredient Description
Ceftriaxone

Ceftriaxone is an antibacterial for systemic use, a third-generation cephalosporin. It inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs) leading to bacterial cell lysis and death.

List of Excipients

None.

Pack sizes and marketing

Medaxonum250 mg, Medaxonum 500 mg, and Medaxonum 1 g are supplied in clear type I glass vials, nominal capacity 10 ml, sealed with a 20 mm diameter grey bromobutyl rubber stopper and aluminium overcap, in a carton with a leaflet.

Medaxonum 2 g are clear type I glass vials having a nominal capacity of 20 ml sealed with a 20 mm rubber stoppers and an aluminium cap.

Cartons containing 1, 10, 50, or 100 vials are available for Medaxonum" 250 mg,
Medaxonum 500 mg, and Medaxonum 1 g.

Cartons containing 1, 10, 25, 50, or 100 vials are available for Medaxonum 2g.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

Medaxonum, 250 mg: 18562
Medaxonum, 500 mg: 18563
Medaxonum, 1 g: 18561
Medaxonum, 2 g: 20741

Medaxonum, 250 mg: 2/2/2000
Medaxonum, 500 mg: 2/2/2000
Medaxonum, 1 g: 2/2/2000
Medaxonum, 2 g: 02/08/2010

Drugs

Drug Countries
MEDAXONUM Cyprus, Hong Kong, Malta

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