United States - English - NLM (National Library of Medicine)

sandoz inc - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] - calcitonin-salmon nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. fracture reduction efficacy has not been demonstrated. calcitonin-salmon nasal spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). - due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see warnings and precautions (5.4)] . - calcitonin-salmon nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women. hypersensitivity to calcitonin-salmon or any of the excipients. reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see warnings and precautions (5.1)] . pregnancy category c: risk summary there are no adequate an

Malta - English - Medicines Authority

essential pharma ltd 7 egham business village, crabtree road, egham, surrey, tw20 8rb , united kingdom - calcitonin, salmon - solution for injection - calcitonin, salmon 100 iu/ml - calcium homeostasis

United States - English - NLM (National Library of Medicine)

mylan institutional llc - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - miacalcin injection is indicated for the treatment of symptomatic paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. there is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. it may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or

United States - English - NLM (National Library of Medicine)

mylan institutional llc - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - miacalcin injection is indicated for the treatment of symptomatic paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. there is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. it may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or

Ireland - English - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - calcitonin, salmon - solution for inj/inf - 50 iu/ml

Israel - English - Ministry of Health

tzamal bio-pharma ltd - calcitonin salmon 200 iu/dose - nasal spray - calcitonin (salmon synthetic) - fortical® nasal spray is indicated for:postmenopausal osteoporosis – fortical® calcitonin-salmon (rdna origin) nasal spray isindicated for the treatment of postmenopausal osteoporosis in women greater than 5 yearspostmenopause with low bone mass relative to healthy premenopausal women. use of fortical®calcitonin-salmon (rdna origin) nasal spray is recommended in conjunction with an adequatecalcium (at least 1000 mg elemental calcium per day) and vitamin d (400 international units perday) intake to retard the progressive loss of bone mass. the evidence of efficacy for calcitoninsalmonis based on increases in spinal bone mineral density (bmd) observed in clinical trials

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

novartis pharma stein ag - calcitonin (calcitonin salmon synthetic) - solution for injection - 100iu/ml

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - salcatonin/calcitonin salmon -

Malta - English - Medicines Authority

novartis pharmaceuticals uk limited - calcitonin, salmon 100 iu/ml - solution for injection

European Union - English - EMA (European Medicines Agency)

unigene uk ltd. - recombinant salmon calcitonin - hypercalcemia; osteitis deformans; bone resorption - calcium homeostasis - calcitonin is indicated for:prevention of acute bone loss due to sudden immobilisation such as in patients with recentosteoporotic fracturespaget's diseasehypercalcaemia of malignancy