البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
salbutamol (salbutamol sulfate)
Arpimed LLC
salbutamol (salbutamol sulfate)
2mg
tablets
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) SALBUTAMOL 2 MG TABLETS 1. NAME OF THE MEDICINAL PRODUCT - Salbutamol NON-PROPRIETARY NAME – Salbutamol 2. QUANTITATIVE AND QUALITATIVE COMPOSITION Each tablet contains: ACTIVE INGREDIENT: Salbutamol sulfate - 2 mg; For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM White, scored cylindrical tablets, the end surface of which are flat. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. For the relief of bronchospasm in bronchial asthmas of all types. 2. Chronic bronchitis. 3. Emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration Oral. _Adults: _ The usual effective dose is 4 mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2 mg three or four times daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2 mg three or four times per day. _Children: _ The following doses should be administered three or four times daily. 2-6 years: 1-2mg 6-12 years: 2mg Over 12 years: 2-4mg The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased. 4.3 CONTRAINDICATIONS 1. Salbutamol should not be used for threatened abortion during the first or second trimester of pregnancy. 2. Salbutamol and beta-blocking drugs such as propranolol should not usually be prescribed together. 3. Salbutamol tablets are contraindicated in patients with a history of hypersensitivity to any of their components. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine. Bronchodilators should not be the only or main treatment in patients with severe or unst اقرأ الوثيقة كاملة