DUOVENT UDV Nebulizer solution (2015)
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Περιεχόμενα
Name of the medicinal product
Duovent UDV (ipratropium bromide/fenoterol hydrobromide).
Summary product information
<b>Route of Administration</b> <b>Dosage Form/Strength</b> <b>Nonmedicinal Ingredients</b> Inhalation Solution/0.5 mg of ipratropium bromide and 1.25 mg fenoterol hydrobromide in 4 mL of isotonic saline ...
Indications and clinical use
DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) is indicated for: treatment of bronchospasm associated with acute severe exacerbations of bronchial asthma or chronic obstructive pulmonary disease ...
Contraindications
Patients with a known hypersensitivity to the component drugs, sympathomimetic amines, atropinics or to any of the product components. For a complete listing, see the Dosage Forms, Composition and Packaging ...
Warnings and precautions
General Like other nebulizer solutions that contain β<sub>2</sub> agonists, DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) should not be used on a regular basis without appropriate concomitant ...
Adverse reactions
Adverse Drug Reaction Overview Frequent undesirable effects of DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) are fine tremor of skeletal muscles and nervousness, less frequent are tachycardia, ...
Drug interactions
Overview Other β adrenergic agents, anticholinergics, xanthine derivatives (such as theophylline) and corticosteroids may enhance the effect of DUOVENT UDV nebulizer solution. The concurrent administration ...
Dosage and administration
Dosing Considerations Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms ...
Overdosage
The effects of overdosage are expected to be primarily related to fenoterol. Overdosage resulting in excessive β adrenergic stimulation may cause tachycardia, palpitations, tremor, hypotension, widening ...
Action and clinical pharmacology
Mechanism of Action DUOVENT UDV nebulizer solution is a combination of the anticholinergic bronchodilator ipratropium bromide and the β<sub>2</sub> adrenergic bronchodilator fenoterol hydrobromide. Ipratropium ...
Storage and stability
Unopened unit dose vials of DUOVENT UDV should be stored at room temperature (15-25°C) and protected from heat and light. If necessary, the solution may be diluted with preservative-free sterile sodium ...
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 ...
Pharmaceutical information
Drug Substance Proper name: ipratropium bromide Chemical name: (1) 8-Azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide; (2) (8r)-3α-Hydroxy-8-isopropyl-1αH,5αH-tropanium ...
Detailed pharmacology
Ipratropium bromide Ipratropium bromide is an anticholinergic agent which, when delivered by aerosol, exerts its effect primarily in the bronchial tree. It abolishes acetylcholine induced bronchospasm ...
Clinical trials
The effect of q.i.d. domiciliary nebulized DUOVENT for 3 weeks was assessed in a placebocontrolled, randomized, double blind, cross-over study in 20 patients with a low bronchodilator response and steroid ...
Toxicology
ACUTE TOXICITY Ipratropium Bromide LD<sub>50</sub> Values for Ipratropium Species Route LD<sub>50</sub>(mg/kg) Mice IV 13.5 Mice-males IV 12.3 Mice-females IV 15.0 Mice SC 322 Mice SC 300 Mice ...
Marketing authorization holder
Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario, L7L 5H4
Submission control number
180942
Date of revision
March 30, 2015
References
Anastasatu C, dutu St, Morgenstern H. Possibilities of reducing the efficient dose of fenoterol by combining it with ipratropium bromide in bronchial asthma. Prax Klin Pneumol 1983; 37:929-930. Chapman ...
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