TYGACIIL Powder for solution for infusion Ref.[7843] Active ingredients: Tigecycline

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

Tygacil 50 mg powder for solution for infusion.

Pharmaceutical Form

Powder for solution for infusion (powder for infusion).

Orange cake or powder.

Qualitative and quantitative composition

Each 5 ml Tygacil vial contains 50 mg of tigecycline. After reconstitution, 1 ml contains 10 mg of tigecycline.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tigecycline

Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains.

List of Excipients

Lactose monohydrate
Hydrochloric acid
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals. Tygacil is distributed in a ten vial tray pack.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

EU/1/06/336/001

Date of first authorisation: 24 April 2006

Date of latest renewal: 22 February 2016

Drugs

Drug Countries
TYGACIL Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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