COMBIVENT UDVS 500 MICROGRAMS/2.5MG PER 2.5ML NEBU
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
IPRATROPIUM BROMIDE MONOHYDRATE SALBUTAMOL SULFATE
Available from:
PCO Manufacturing
Dosage:
0.5/2.5 Base mg/unit
Pharmaceutical form:
Nebuliser Solution
Authorization date:
2004-03-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Combivent UDVs 500 micrograms/2.5mg per 2.5ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml single dose unit contains:
500 micrograms ipratropium bromide (as the monohydrate) and 2.5 mg salbutamol (as the sulphate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Combivent UDVs are indicated for the management of bronchospasm in patients suffering from chronic obstructive
pulmonary disease who require regular treatment with both ipratropium and salbutamol
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose is:
_Adults (including elderly patients and children over 12 years):_
1 vial three or four times daily.
Children:
There is no experience of the use of COMBIVENT UDVs in children under 12 years.
COMBIVENT UDVs are intended for inhalation only and may be administered from a suitable nebuliser or an
intermittent positive pressure ventilator. The single dose units should not be taken orally or administered parenterally.
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.
Instructions for Use:
1. Prepare the nebuliser by following the manufacturer's instructions and the advice of your doctor.
2. Carefully separate a new vial from the strip. NEVER use one that has been opened already.
3. Open the vial by simply twisting off the top, always taking care to hold it in an upright position.
4. Unless otherwise instructed by your doctor squeeze all the contents of the plastic vial into the nebuliser
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