IPRAVENT Pressurised inhalation, solution Ref.[27780] Active ingredients: Ipratropium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Product name and form

Ipravent CFC-Free Inhaler 20 micrograms/ actuation pressurised inhalation, solution.

Pharmaceutical Form

Pressurised inhalation, solution.

Each container is filled with clear, colourless liquid, free from suspended particles.

Qualitative and quantitative composition

One metered dose (ex-valve) contains 20 micrograms of ipratropium bromide (as the monohydrate). This is equivalent to a delivered dose (ex-actuator) of 18 micrograms ipratropium bromide (as the monohydrate).

Each metered dose (ex-valve) contains 8.4 mg of ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ipratropium

Ipratropium is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Ipratropium appears to inhibit vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of Ca++, which is caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Ca++ release is mediated by the second messenger system consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).

List of Excipients

1, 1, 1, 2-tetrafluoroethane (HFA 134a)
Ethanol anhydrous
Purified water
Citric acid anhydrous

Pack sizes and marketing

An Inhaler comprises of 19 ml pressurised pure aluminium anodized canister (containing 12.8 ml of solution) sealed with a 50 ยตl metering valve made up of a thermoplastic and a plastic actuator made up of polypropylene having a white mouthpiece fitted with a green mouthpiece cover.

Each canister contains 200 metered actuations of 20 micrograms of ipratropium bromide.

Ipravent CFC-Free Inhaler contains a propellant, HFA134a, and does not contain any chlorofluorocarbons (CFCs).

Marketing authorization holder

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Marketing authorization dates and numbers

PLGB 36390/0342

05/11/2013

Drugs

Drug Countries
IPRAVENT Brazil, Canada, Ecuador, Hong Kong, Ireland, Malta, Poland, Romania, United Kingdom

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