Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Strontium ranelate
Servier Laboratories Ltd
M05BX03
Strontium ranelate
2gram
Granules
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06060200; GTIN: 5017476141002
OBJECT 1 PROTELOS Summary of Product Characteristics Updated 21-Oct-2016 | Servier Laboratories Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product PROTELOS 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, - in adult men, at high risk of 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, PROTELOS should be administered in-between meals. Given the slow absorption, PROTELOS 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 effi Preberite celoten dokument