DUOVENT UNIT DOSE VIALS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
IPRATROPIUM BROMIDE FENOTEROL HYDROBROMIDE
Available from:
Boehringer Ingelheim Limited
Dosage:
0.5mg/1.25 Mg/Dose
Pharmaceutical form:
Nebuliser Solution
Authorization date:
1993-12-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Duovent UDVs 0.5mg/1.25mg per 4ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 ml single dose unit contains 0.5 mg of ipratropium bromide (as monohydrate) and 1.25 mg of fenoterol
hydrobromide.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution
A clear, colourless or almost colourless solution, free from suspended particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of acute severe asthma or reversible obstructive airways disorders requiring treatment by nebuliser, in
patients who have not responded sufficiently well to anticholinergic therapy or in situations where the beta
2
agonist
alone has produced unacceptable levels of side effects.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_
The recommended dose for adults and children over 14 years is one vial (4 ml) three or at maximum four times daily.
_Children:_
Use in children below the age of 14 years is not recommended.
Use in children should be supervised by a responsible adult.
The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular
nebuliser being used; if dilution is necessary use only sterile sodium chloride 0.9% solution.
4.3 CONTRAINDICATIONS
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to fenoterol hydrobromide or atropine-
like substances or to any of the excipients of the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
It is dangerous to exceed the recommended dose.
In the case of acute, rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.
For prolonged use, on demand (symptom-oriented) treatment may be preferable to regular us
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