RIFADIN Solvent Ref.[7702] Active ingredients: Rifampicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Rifadin for Infusion 600 mg.

Pharmaceutical Form

Lyophilisate (for reconstitution prior to use) and accompanying ampoule of solvent.

Qualitative and quantitative composition

Rifampicin BP 600 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rifampicin

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

List of Excipients

Sodium sulfoxylate formaldehyde
Sodium hydroxide

Solvent:

Water for injections

Pack sizes and marketing

20ml clear neutral glass vial sealed with butyl rubber stopper and aluminium/plastic “flip-off” cap (colour coded blue) containing 600mg Rifampicin and 10ml clear glass ampoule containing solvent.

Pack size: combination of 1 vial of lyophilisate and 1 ampoule of solvent.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0051

Date of First Authorisation: 15 December 1982
Date of latest renewal: 09 April 2005

Drugs

Drug Countries
RIFADIN Australia, Estonia, Hong Kong, Ireland, Japan, Malta, Mexico, Netherlands, New Zealand, United Kingdom, United States, South Africa

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