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ZINFORO Powder for concentrate for solution (2018)

Active ingredients: Ceftaroline fosamil

Product Name and Form

Zinforo 600 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion (powder for concentrate).

A pale yellowish-white to light yellow powder.

Qualitative and Quantitative Composition

Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil.

After reconstitution, 1 ml of the solution contains 30 mg of ceftaroline fosamil.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Ceftaroline fosamil

In vitro studies have shown that ceftaroline is bactericidal and able to inhibit bacterial cell wall synthesis in methicillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP) due to its affinity for the altered penicillin-binding proteins (PBPs) found in these organisms. As a result, minimum inhibitory concentrations (MICs) of ceftaroline against a proportion of these organisms tested fall into the susceptible range.

List of excipients

Arginine

Pack sizes and Marketing

20 ml glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.

The medicinal product is supplied in packs of 10 vials.

Marketing authorization holder
Authorization dates

Pfizer Ireland Pharmaceuticals, Operations Support Group, Ringaskiddy, County Cork, Ireland

Date of first authorisation: 23 August 2012
Date of the latest renewal: 24 April 2017

Marketing authorization number:

EU/1/12/785/001