Atrosol 250 mcg/2ml Inhaler Solution 20 pieces 2 ml

Name of the medicinal product Ipratropium Bromide 250 micrograms/1ml Nebuliser Solution Ipratropium Bromide 500 micrograms/2ml Nebuliser Solution. 2. Qualitative and quantitative composition Each ampoule contains ipratropium bromide at 250 micrograms/1ml i.e. 250 micrograms in 1ml and 500 micrograms in 2ml. 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 Ipratropium bromide is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). Ipratropium bromide is indicated, when used concomitantly with inhaled beta2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma. 4.2 Posology and method of administration This medicinal product is for inhalation use only. The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only Ipratropium Bromide Nebuliser Solution 1 ml should be used. The following doses are recommended: Adults (including the elderly) and children over 12 years of age: 250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or one vial of 500 micrograms in 2ml) 3 to 4 times daily. The exact starting dose may vary depending on local guidelines. 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 children over 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 1ml) 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. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a doctor should be consulted immediately. .Contraindications Hypersensitivity to atropine or ipratropium bromide or to any of the excipients listed in section 6.1. Special warnings and precautions for use Use of the nebuliser solution should be subject to close medical supervision during initial dosing. The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.