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ALFENTANIL Solution for injection (2018)

Product Name and Form

Alfentanil 5 mg/ml solution for injection.

Pharmaceutical form

Solution for Injection.

The product is a clear and colourless solution.

Qualitative and Quantitative Composition

Each 1 ml of Alfentanil 5 mg/ml solution for injection contains:

Alfentanil hydrochloride 5.44 mg, equivalent to 5.0 mg alfentanil base

Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per each 5mg dose, that is to say essentially ‘sodium-free’.

For the full list of excipients, see section 6.1.

List of excipients

Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and Marketing

Clear glass ampoules (Ph Eur Type I, one point cut) containing 5 mg/1 ml.

Original pack containing 5 or 10 ampoules of 1 ml each.

Marketing authorization holder
Authorization dates

hameln pharma plus gmbh, Langes Feld 13, D-31789, Hameln, Germany

24/11/2010

Marketing authorization number:

PL 25215/0006