NOVALGIN Solution for injection Ref.[50517] Active ingredients: Metamizole sodium

Source: Web Search  Revision Year: 2017  Publisher: Manufactured by Sanofi Egypt S.A.E under license from Sanofi-Aventis Germany

Product name and form

Novalgin 1 g solution for injection.

Pharmaceutical Form

Solution for injection, nearly colourless to yellow.

Qualitative and quantitative composition

Novalgin 1 g solution for injection.

1 ml solution for injection contains 500 mg metamizole sodium.

Each vial with 2 ml solution for injection contains 1 g metamizole sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Metamizole sodium

Metamizole sodium is a pyrazolone derivative with analgesic, antipyretic and slight antiinflammatory and spasmolytic properties. It has the most potent analgesic effect of all the pyrazolone derivatives. As with other analgesics, its mechanism of action has not been elucidated in detail. It includes inhibition of prostaglandin synthesis (PGE1 and PGE2) and reversible inhibition of platelet aggregation. It inhibits cyclo-oxygenase and influences the effect of arachidonic acid.

List of Excipients

Water for injection

Pack sizes and marketing

Novalgin 1 g solution for injection:

Brown, cylindrical glass vials supplied in packs of 5 × 2 ml and 10 × 2 ml and
hospital packs of 96 × 2 ml and 100 × 2 ml.

Brown, cylindrical glass vials supplied in packs of 4 × 5 ml, 6 × 5 ml and
hospital packs of 20 × 5 ml and 24 × 5 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Manufactured by Sanofi Egypt S.A.E under license from Sanofi-Aventis Germany

Marketing authorization dates and numbers

Novalgin 1 g solution for injection: 619647.00.03 : 619647.01.03

Date of first authorisation: 31 March 1998
Date of latest renewal: 07 August 2006

Drugs

Drug Countries
NOVALGIN Austria, Germany, Turkey

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