DUOVENT UDV Nebulizer solution Ref.[50624] Active ingredients: Ipratropium

Source: Marketing Authorisation Holder  Revision Year: 2015 

Product name

Duovent UDV (ipratropium bromide/fenoterol hydrobromide).

Summary product information

Route of Administration Dosage Form/Strength Nonmedicinal Ingredients
InhalationSolution/0.5 mg of ipratropium bromide and 1.25 mg fenoterol hydrobromide in 4 mL of isotonic salinesodium chloride, hydrochloric acid

Dosage forms, composition and packaging

DUOVENT nebulizer solution is provided as plastic single unit dose vials (UDV) filled with 4 mL of clear, colourless, isotonic aqueous solution containing 0.5 mg of ipratropium bromide and 1.25 mg fenoterol hydrobromide.

Each millilitre of the solution contains 0.125 mg of ipratropium bromide and 0.3125 mg of fenoterol hydrobromide. Non-medicinal ingredients include sodium chloride and hydrochloric acid to adjust the pH.

Each carton contains 2 strips of 10 × 4 mL UDVs. Each UDV strip is packaged in an aluminum/Low Density Polyethylene (LDPE) pouch.

Marketing Informations Authorization Dates
Authorization holder:

Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario, L7L 5H4

Submission control number:
180942
Date of revision:

March 30, 2015

Drugs

Drug Countries
DUOVENT Brazil, Singapore, South Africa

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