CEFTRIAXONE Powder for solution for injection Ref.[6616] Active ingredients: Ceftriaxone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Product name and form

Ceftriaxone 1g Powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection (Powder for injection).

White to pale yellow crystalline powder.

Qualitative and quantitative composition

Each vial contains ceftriaxone sodium equivalent to 1g of ceftriaxone.

Excipient with known effect: Each gram of ceftriaxone contains approximately 82 mg (3.6mmol) of sodium.

For the full list of excipients, see section 6.1.

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

Ceftriaxone is supplied in Type II 15ml clear glass vials, closed with a Type I rubber stopper uncoated/coated in Omniflex and sealed with an aluminium/plastic cap.

The vials are packed in boxes of 1, 5, 10, 25 or 50 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization dates and numbers

PL 29831/0034

Date of first authorisation: 16 October 2007

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