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

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

physicians total care, inc. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] in 0.09 ml - calcitonin-salmon nasal spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. calcitonin-salmon nasal spray should be reserved for patients who refuse or cannot tolerate estrogens or in whom estrogens are contraindicated. use of calcitonin-salmon nasal spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin d (400 i.u. per day) intake to retard the progressive loss of bone mass. the evidence of efficacy is based on increases in spinal bone mineral density observed in clinical trials. two randomized, placebo controlled trials were conducted in 325 postmenopausal females [227 calcitonin-salmon nasal spray treated and 98 placebo treated] with spinal, forearm or femoral bone mineral density (bmd) at least one standard deviation below normal for healthy premenopausal females. these studies conducted over two years demonstrated that 2

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

par pharmaceutical, inc. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] in 0.09 ml - calcitonin salmon nasal solution 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 solution 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 solution 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)]. risk summary calcitonin salmon nasal solution is not i

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

apotex corp. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] - calcitonin salmon (synthetic origin) 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 (synthetic origin) 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 (synthetic origin) 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)] . risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there are no data with the use of calcitonin salmon nasal spray in pregnant women. in an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 418 times the recommended parenteral human dose caused a decrease in fetal birth weights. no adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see data).   data animal data calcitonin salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 international units/m2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area.   no embryo/fetal toxicities related to calcitonin salmon nasal spray were reported from maternal subcutaneous daily doses in rats up to 80 international units/kg/day from gestation day 6 to 15. risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. calcitonin has been shown to inhibit lactation in rats. safety and effectiveness in pediatric patients have not been established. in a multi-centered, double-blind, randomized clinical study of calcitonin salmon nasal spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. calcitonin salmon (synthetic origin) (kal" si toe' nin) nasal spray for nasal use only. important information about your calcitonin salmon (synthetic origin) nasal spray: - a single spray of calcitonin salmon (synthetic origin) nasal spray contains 1 daily dose of medicine. - each calcitonin salmon (synthetic origin) nasal spray bottle contains the right amount of medicine. the bottle may not be completely filled to the top. this is normal. - this package contains 1 bottle of calcitonin salmon (synthetic origin) nasal spray with attached pump. - store unopened bottles of calcitonin salmon (synthetic origin) nasal spray in the refrigerator between 2°c to 8°c (36°f to 46°f). do not freeze. - after you open your bottle of calcitonin salmon (synthetic origin) nasal spray, store it at room temperature between 20°c to 25°c (68°f to 77°f) in an upright position. do not shake the bottle. - to make sure you get the right dose of calcitonin salmon (synthetic origin) nasal spray medicine you must prime each new bottle and pump before you use it for the first time. - check to see if the bottle and pump has already been primed by pressing on the pump 1 time. see figure 2. - if you see a full spray from the pump, the bottle and pump has already been primed for you. - if you do not see a full spray, you must prime the bottle and pump. - hold the bottle upright with your pointer finger and middle finger on the 2 side arms of the pump, and your thumb on the bottom of the bottle. firmly press down on the arms of the pump and press down again if needed until you see a full spray of medicine. see figure 2. - now your calcitonin salmon (synthetic origin) nasal spray is ready for you to use. - do not prime the pump before you use it each day because this will waste your medicine. - keep your head upright. carefully tilt the bottle and place the nose spray pump into 1 side of your nose. - give 1 spray of calcitonin salmon (synthetic origin) nasal spray, 1 time daily, in 1 side of your nose (nostril). spray your medicine in a different side of your nose each day. - you do not need to breathe or inhale while you are giving your dose. - you may not feel the spray inside your nose. - some of the medicine may drip out of your nose. this is normal, and you are still getting all of the medicine you need. - dry the nose spray pump with a clean cloth. - be careful not to push down on the pump while you are putting the cap back on it. - do not refrigerate calcitonin salmon (synthetic origin) nasal spray between doses. - store calcitonin salmon (synthetic origin) nasal spray upright. - do not shake the bottle. when should i throw away calcitonin salmon (synthetic origin) nasal spray? - unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box. - throw away calcitonin salmon (synthetic origin) nasal spray after you use 14 doses (2 ml fill) or 30 doses (3.7 ml fill) (sprays). - throw away calcitonin salmon (synthetic origin) nasal spray bottles left at room temperature (opened or unopened) for more than 30 days (2 ml fill) or 35 days (3.7 ml fill). for more information on calcitonin salmon (synthetic origin) nasal spray, call apotex corp. at 1-800-706-5575. this patient information and instructions for use has been approved by the u.s. food and drug administration. apotex inc. calcitonin salmon (synthetic origin) nasal spray revised: november 2017

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

bryant ranch prepack - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon nasal solution 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 solution 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 solution 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)]. risk summary calcitonin salmon nasal solution is not i

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

hikma pharmaceuticals usa inc.(dba leucadia pharmaceuticals) - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 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. calcitonin salmon 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). calcitonin salmon 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 furose

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

par pharmaceutical, inc. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 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. calcitonin salmon 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). calcitonin salmon 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 furose

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

upsher-smith laboratories, inc. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 2200 [iu] in 1 ml - fortical nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. fracture reduction efficacy has not been demonstrated. fortical 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 and well-controlled

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

physicians total care, inc. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 2200 [iu] in 1 ml - fortical® calcitonin-salmon (rdna origin) nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. use of fortical® calcitonin-salmon (rdna origin) nasal spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin d (400 international units per day) intake to retard the progressive loss of bone mass. the evidence of efficacy for calcitonin-salmon is based on increases in spinal bone mineral density (bmd) observed in clinical trials. two randomized, placebo-controlled trials were conducted in 325 postmenopausal women (227 treated with calcitonin-salmon nasal spray and 98 treated with placebo) with spinal, forearm or femoral bmd at least one standard deviation below the normal value for healthy premenopausal women. these studies conducted over two years demonstrated that 200 international units daily of calcitonin-salmon nasal spray

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

mylan institutional llc - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] in 1 ml - 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