BEROTEC Inhaler Ref.[50446] Active ingredients:

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ingelheim Pharmaceuticals (Pty) Ltd, 407 Pine Avenue, Randburg, South Africa

Product name and form

BEROTEC 100 HFA.

Pharmaceutical Form

Clear, colourless or almost colourless liquid under pressure in a one-piece stainless steel canister fitted with a metering valve.

Qualitative and quantitative composition

Each metered dose (puff) provides fenoterol hydrobromide 100 μg.

Propellant: 1,1,1,2 – Tetrafluoroethane (HFA 134a).

Other excipients: citric acid anhydrous, purified water, ethanol absolute (30% m/m).

List of Excipients

Pack sizes and marketing

Metered aerosol complete with a mouthpiece.

Canister of 10 ml, providing 200 metered doses.

Marketing authorization holder

Ingelheim Pharmaceuticals (Pty) Ltd, 407 Pine Avenue, Randburg, South Africa

Marketing authorization dates and numbers

34/10.2.1/0367

Drugs

Drug Countries
BEROTEC Austria, Brazil, Germany, Estonia, Japan, Lithuania, Poland, South Africa

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