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Patients should be advised to consult a physician or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea (difficulty in
breathing) if additional inhalations of Ipratropium bromide + Salbutamol (Combivent UDV) do not produce an adequate improvement.
If higher than recommended doses of Ipratropium bromide + Salbutamol (Combivent UDV) are required to control symptoms, the patient’s therapy plan should be reviewed.
In asthma, concomitant anti-inflammatory therapy should be considered.
Dosage: For nebulization of Ipratropium bromide + Salbutamol (Combivent UDV) solution for inhalation: Children 2 to 12 years: 3 drops/kg/dose (maximum dose 2500 mcg of salbutamol) every 6 to 8 hours.
Adults (including elderly patients) and adolescents over 12 years of age: One (1) unit dose vial every 6 to 8 hours.
The following doses of Ipratropium bromide + Salbutamol (Combivent UDV) are recommended for adults (including elderly patients): Ipratropium bromide + Salbutamol (Combivent UDV) nebulizer solution in unit dose vials may be administered from a suitable nebulizer or an intermittent positive pressure ventilator.
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 or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician.
The treatment with the solution for inhalation in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases two unit dose vials may be required for symptom relief. Administration should be stopped when sufficient symptom relief is achieved.
Treatment of acute attacks: One (1) unit dose vial is sufficient for prompt symptom relief in many cases.
In severe cases if an attack has not been relieved by one unit dose vial, the administration of a second unit dose vial may be required. Patients should
be advised to consult the physician or the nearest hospital immediately in these cases.
Maintenance treatment: 1 unit dose vial three or four times daily.
Ipratropium bromide + Salbutamol (Combivent UDV) has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Special Populations: Patients with hepatic or renal impairment Ipratropium bromide + Salbutamol (Combivent UDV) has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
Instructions for use/handling: The unit dose vials are intended only for inhalation with suitable nebulizing devices and must not be taken orally or administered parenterally.
The content of the unit dose vials does not need to be diluted for nebulization.
1. Prepare the nebulizer for filling, according to the instructions provided by the manufacturer or physician.
2. Open the pouch foil and tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebulizer reservoir.
5. Assemble the nebulizer and use as directed.
6. After use throw away any solution left in the reservoir and clean the nebulizer, following the manufacturer's instructions.
