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Rocephin 250mg, 1g and 2g vials (2012)

Active ingredients: Ceftriaxone

Product Name and Form

Rocephin 250mg vials.

Rocephin 1g vials.

Rocephin 2g vials.

Pharmaceutical form

Powder for solution for injection.

Powder for solution for injection.

Powder for solution for infusion.

Qualitative and Quantitative Composition

Each 250mg vial contains 250mg ceftriaxone as 298.3mg hydrated disodium ceftriaxone.

Each 1g vial contains 1g ceftriaxone as 1.19g hydrated disodium ceftriaxone.

Each 2g vial contains 2g ceftriaxone as 2.39g hydrated disodium ceftriaxone.

Chemical substance
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

Rocephin 250mg and 1g: Type 1 Ph. Eur 15ml glass vial with teflonised rubber stopper and aluminium cap, containing a sterile, white to yellowish-orange crystalline powder. Packs of 1 vial.

Rocephin 2g: Type II Ph. Eur 50ml glass vial with teflonised rubber stopper and aluminium cap, containing a sterile, white to yellowish-orange crystalline powder. Packs of 1 vial.

Each gram of Rocephin contains approximately 3.6mmol sodium.

Marketing authorization holder
Authorization dates

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

23 October 2003

Marketing authorization number:

Vials 250mg: PL 00031/0169

Vials 1g: PL 00031/0171

Vials 2g: PL 00031/0172