BERODUAL RESPIMAT Inhalation solution Ref.[50758] Active ingredients: Ipratropium

Source: Z-Index G-Standaard (NL)  Revision Year: 2022  Publisher: Boehringer Ingelheim International GmbH, Binger StraรŸe 173, D-55216 Ingelheim am Rhein, Germany

Product name and form

Berodual Respimat, oplossing voor inhalatie 20 microgram/50 microgram.

Pharmaceutical Form

Inhalation solution.

Clear, colourless, inhalation solution.

Qualitative and quantitative composition

The delivered dose (the dose that leaves the mouthpiece of the Berodual Respimat) is 20 microgram ipratropium bromide monohydrate (equivalent to 19 microgram ipratropium bromide anhydrous) and 50 microgram fenoterol hydrobromide per puff.

Excipient with known effect: This medicine contains 1.12 microgram benzalkonium chloride in each actuation.

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

Benzalkonium chloride, Disodium edetate, Water, purified, Hydrochloric acid for pH adjustment.

Pack sizes and marketing

Type and material of the container in contact with the medicinal product:

Solution filled into a 4.5 ml polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminium cylinder.

Pack sizes and devices supplied:

  • Original package: 1 Respimat inhaler and one 4.5 ml cartridge, delivering 120 metered doses.
  • Double package: 2 single packages, each containing 1 Respimat inhaler and one 4.5 ml cartridge, each delivering 120 metered doses.
  • Hospital package: 8 single packages, each containing 1 Respimat inhaler and one 4.5 ml cartridge, each delivering 120 metered doses.

Not all pack sizes may be marketed.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger StraรŸe 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

Berodual Respimat, oplossing voor inhalatie 20 microgram/ 50 microgram: RVG 26896

2 October 2002 / 2 October 2007

Drugs

Drug Countries
BERODUAL Austria, Estonia, Lithuania, Mexico, Netherlands, Poland, Singapore, United Kingdom

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