ATROVENT Nebuliser solution Ref.[6398] Active ingredients: Ipratropium

The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only ATROVENT 250 UDVs, 1 ml should be used. The following doses are recommended:

Adults (including the elderly) and adolescents >12 years of age

250-500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1 vial of 500 micrograms in 2 ml) 3 to 4 times daily.

For treatment of acute bronchospasm, 500 micrograms.

Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.

It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment. Daily doses exceeding 2 mg in adults and adolescents >12 years of age should only be given under medical supervision.

Children 6-12 years of age

250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total daily dose of 1mg (4 vials).

The time interval between doses may be determined by the physician.

Children 0–5 years of age (for treatment of acute asthma only)

125–250 micrograms (i.e. half to one vial of 250 micrograms in 1 ml) up to a total daily dose of 1 mg (4 vials).

Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age.

For acute bronchospasm, repeated doses may be administered until the patient is stable.

If therapy does not produce a significant improvement or if the patient’s condition gets worse, medical advice must be sought. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.

ATROVENT UDVs may be combined with a short-acting beta2-agonist in the same nebuliser chamber, for simultaneous administration where co-administration is required. The solution should be used as soon as possible after mixing and any unused solution should be discarded.

ATROVENT UDVs can be administered using a range of commercially available nebulising devices. The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used (usually 2–4 mL); if dilution is necessary use only sterile sodium chloride 0.9% solution.

ATROVENT UDVs and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.

The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.

Please refer to the patient information leaflet for instructions on use with a nebuliser.

No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of ATROVENT, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.

Shelf life: 24 months (unopened).

As the product contains no preservative, a fresh vial should be used for each dose and the vial should be opened immediately before administration. Any solution left in the vial should be discarded.

Do not store above 25°C. Keep vials in the outer carton.

Polyethylene unit dose vials containing either 1 ml or 2 ml of solution.

Pack sizes of 10, 20, 30, 50, 60, 80, 100, 120, 150, 200, 300, 500 and 1000.

Not all pack sizes may be marketed.

None.