PARVOLEX Solution for infusion Ref.[2452] Active ingredients: Acetylcysteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath, Ireland

Product name and form

Parvolex 200 mg/ml Concentrate for Solution for Infusion.

Pharmaceutical Form

Solution for infusion.

Clear colourless solution contained in a 10 ml clear colourless Type I glass ampoule.

Qualitative and quantitative composition

Each ml contains Acetylcysteine 200mg.

Each 10 ml contains 322.6 mg of sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Acetylcysteine

Acetylcysteine is N-acetyl derivative of cysteine. Used as a mucolytic agent to reduce the viscosity of mucous secretions.

List of Excipients

Disodium edetate
Sodium hydroxide
Water for injections

Pack sizes and marketing

Clear, Type I glass, 10ml snap ring ampoules. 10 × 10ml ampoules are packed in cartons.

Marketing authorization holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath, Ireland

Marketing authorization dates and numbers

PL 35104/0011

14/10/1992 / 14/01/2003

Drugs

Drug Countries
PARVOLEX Ireland, Malta, United Kingdom, South Africa

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