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AKINETON Solution for injection

Active ingredients: Biperiden

Product Name and Form

Akineton 5 mg – solution for injection.

Pharmaceutical form

Clear, colourless solution for injection, free from suspended matter.

pH 4.8-5.8

Qualitative and Quantitative Composition

Active substance: Biperiden Lactate.

1 ampoule of 1 ml solution for injection contains 5 mg Biperiden Lactate equivalent to 3.9 mg Biperiden.

Excipient with known effect: less than 1 mmol sodium (sodium lactate).

For the full list of excipients, see section 6.1.

Chemical substance
Description

Biperiden is a predominantly centrally acting anti-cholinergic. It has a peripheral effect, which is low in comparison to atropine. Biperiden binds competitively to peripheral and central muscarinic receptors (primarily M1).

List of excipients

Sodium-(RS)-lactate
Water for injection

Pack sizes and Marketing

5 white-glass ampoules (type I) of 1 mlsolution for injection.

50 (10x5) white-glass ampoules (type I) of 1 ml solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Desma GmbH, Peter-Sander-Str. 41b, 55252, Mainz-Kastel, Germany, Tel: +49 (0) 6134 21079 0, Fax: +49 (0) 6134 21079 24

Marketing authorization number: