Nchi: Malta
Lugha: Kiingereza
Chanzo: Malta Medicines Authority
ARGIPRESSIN
Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom
H01BA01
ARGIPRESSIN 20 pressor units/ml
SOLUTION FOR INJECTION
ARGIPRESSIN 20 pressor units/ml
POM
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
Withdrawn
2006-03-29
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Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pitressin® 20PU/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml contains 0.4mg of synthetic Pitressin _(50 _pressure unit per rng) which is equivalent to argipressin 20 pressor units. 3. PHARMACEUTICAL FORM A clear, sterile solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For use in diabetes insipidus, when this is not of nephrongenic origin and control of bleeding from oesophageal varices. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Subcutaneous, intravenous or intramuscular injection. Adults Diabetes insipidus: A dose of 0.25m1 to I ml _(5 _to 20 units) by subcutaneous or intramuscular injection every four hours. Oesophageal varices: For the initial control of variceal bleeding Pitressin should be given intravenously. Pitressin, 20 units diluted in 100ml dextrose _5% _w/v may be infused over a 15 minute period. Elderly (over 65 years) As for adults. No clinical or pharmacokinetic data specific to this age group are available. However, the drug has been used successfully at normal dosage in the elderly. Children and infants Page 2 of 5 No dose recommended. 4.3 CONTRAINDICATIONS Anaphylaxis or hypersensitivity to the drug or its components. Vascular disease (especially disease of coronary arteries), chronic nephritis (until reasonable blood nitrogen concentrations attained). 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE This drug should not be used in patients with systemic hypertension or vascular disease, especially disease of the coronary arteries, except with extreme caution. In such patients, ev Soma hati kamili