देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Strontium ranelate (as anhydrous form)
SERVIER (S) PTE LTD
M05BX03
2000 mg
GRANULE, FOR SUSPENSION
Strontium ranelate (as anhydrous form) 2000 mg
ORAL
Prescription Only
Les Laboratoires Servier Industrie
ACTIVE
2006-07-14
1 1. NAME OF THE MEDICINAL PRODUCT PROTOS 2 g granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate. Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension Yellow granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe osteoporosis in postmenopausal women at high risk for fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1). The decision to prescribe strontium ranelate should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician with experience in the treatment of osteoporosis. Posology The recommended dose is one 2 g sachet once daily by oral administration. Due to the nature of the treated disease, strontium ranelate is intended for long-term use. The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTOS should be administered in-between meals. Given the slow absorption, PROTOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2)._ _ _ _ Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate. _Elderly patients _ The efficacy and safety of strontium ranelate have been established in a broad age range (up पूरा दस्तावेज़ पढ़ें
1 1. NAME OF THE MEDICINAL PRODUCT PROTOS 2 g granules for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g of strontium ranelate. Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension Yellow granules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe osteoporosis in postmenopausal women at high risk for fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1). The decision to prescribe strontium ranelate should be based on an assessment of the individual patient’s overall risks (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician with experience in the treatment of osteoporosis. Posology The recommended dose is one 2 g sachet once daily by oral administration. Due to the nature of the treated disease, strontium ranelate is intended for long-term use. The absorption of strontium ranelate is reduced by food, milk and derivative products and therefore, PROTOS should be administered in-between meals. Given the slow absorption, PROTOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2). _ _ _ _ Patients treated with strontium ranelate should receive vitamin D and calcium supplements if dietary intake is inadequate. _Elderly _ The efficacy and safety of strontium ranelate have been established in a broad age range (up to 100 years at inclusion) of postmenopausal women with osteoporosis. No dose adjustment is required in relation to age. _Renal impairment _ 2 Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2 पूरा दस्तावेज़ पढ़ें