دواعي استعمال بروتيلوز 2جم 7 اكياس

Strontium ranelate 2 g granules for oral suspension in sachets (box of 7) for severe osteoporosis.

• Treatment of severe osteoporosis in postmenopausal women at high risk of fracture, to reduce vertebral and hip fracture risk.الفئة: Postmenopausal womenEuropean Medicines Agency
• Treatment of severe osteoporosis in adult men at increased risk of fracture.الفئة: Adult menEuropean Medicines Agency

• Most common adverse reactions in trials were nausea and diarrhoea, mostly at the start of treatment.نشرة دولية لنفس المنتج · European Medicines Agency

• Hypersensitivity to strontium ranelate or excipients; current or previous venous thromboembolism; temporary or permanent immobilisation; established, current or past ischaemic heart disease, peripheral arterial disease or cerebrovascular disease; uncontrolled hypertension.نشرة دولية لنفس المنتج · European Medicines Agency

• Increased myocardial infarction in pooled placebo-controlled studies: assess cardiovascular risk before starting and monitor every 6-12 months; stop if ischaemic heart, peripheral arterial or cerebrovascular disease develops or hypertension becomes uncontrolled.نشرة دولية لنفس المنتج · European Medicines Agency
• Associated with increased incidence of venous thromboembolism including pulmonary embolism.نشرة دولية لنفس المنتج · European Medicines Agency

• Food, milk, dairy products and calcium-containing medicinesReduce strontium ranelate bioavailability by about 60-70%; separate by at least two hours.European Medicines Agency
• Oral tetracyclines and quinolone antibioticsComplex formation reduces antibiotic absorption; suspend strontium ranelate during such treatment.European Medicines Agency
• Aluminium and magnesium hydroxide antacidsSlightly reduce absorption when given before or with the dose; preferably take antacids at least two hours after.European Medicines Agency

• No data in pregnant women; reversible bone effects in offspring of animals at high doses; if used inadvertently during pregnancy, treatment must be stopped.نشرة دولية لنفس المنتج · European Medicines Agency
• Likely excreted in human milk; should not be used during breast-feeding.نشرة دولية لنفس المنتج · European Medicines Agency

• Monitor cardiovascular risk regularly, generally every 6 to 12 months.نشرة دولية لنفس المنتج · European Medicines Agency

• Increases bone formation and reduces bone resorption.