Calcitonin-salmon

Calcitonin salmon four units/kg SQ ql2h ° Onset within 1-2 h... 

The appearance of erythema or a wheal within 15 min indicates a positive reaction, and calcitonin salmon should not be administered... 

Calcitonin is a naturally occurring mammalian hormone that plays a major role in regulation of calcium levels. It inhibits bone resorption by binding to osteoclast receptors. Compared with mammalian calcitonin, salmon calcitonin has high potency and extended duration of action. Although commercial formulations of calcitonin-salmon actually are synthetic and not derived from salmon, they contain the same amino acid sequence as calcitonin of salmon origin. 

Calcitonin (Miacalcin, Miacalcin Nasal Spray) is a synthetic 32-amino acid polypeptide that is identical to salmon calcitonin. Salmon calcitonin is more potent than human calcitonin because of its higher affinity for the human calcitonin receptor and its slower metabolic clearance. Administration is by subcutaneous or intramuscular injection or by nasal spray. The absorption of the nasal form is slower than that of the parenteral routes. 

Novartis (2002). Miacalcin (Calcitonin-Salmon) T2002-84 89018101. Available at www. http //www.pharma.us.novartis.com/product/pi/pdf/miacalcin injection.pdf search = %22 Miacalcin%20(Calcitonin-Salmon)%20T2002-84%2089018101%22 downloaded 10/04/ 2006. 

Nasal Spray (Fortical, Miacalcin Nasal) 200 international units/activation (calcitonin-salmon). 

Skin testing Before treatment in patients with suspected sensitivity to calcitonin-salmon ... 

Oral 5, 10, 35, 40, 70 mg tablets 70 mg/75 mL oral solution Calcitonin-Salmon... 

Calcitonin-salmon, 2200 U per mL (corresponding to 200 U per 0.09 mL actuation), sodium chloride, benzalkonium... 

Ipratropium bromide Calcitonin-salmon Dihydroergotamine Caffeine... 

Warning Possibility of systemic allergic reaction exists because Calcitonin-salmon is a polypeptide... 

Calcitonin is a peptide hormone produced in the thyroid gland that serves to lower serum calcium and phosphate levels by inhibiting bone resorption. Calcitonin has been used in the treatment of a variety of diseases, such as primary hyperparathyroidism, Paget s disease, and postmenopausal osteoporosis [99,100]. Salmon calcitonin has a longer half-life than human calcitonin. Salmon calcitonin, 3.6 kDa, is available as a nasal formulation that contains only benzalkonium chloride as a preservative, without an absorption enhancer, and as a parenteral product for injection. The direct effect of benzalkonium chloride on the nasal mucosa is under... 

Intranasal calcitonin (salmon calcitonin) reduces the incidence of vertebral fractures, but evidence is lacking on whether it reduces the incidence of non-vertebral fractures. 

Case Study 1 Fortical [Calcitonin-Salmon (rDNA Origin)]... 

On July 10, 2006, Nastech was notified by the FDA that its ANDA for intranasal calcitonin salmon was not approvable at present based on concerns relating to the potential for immunogenicity that might result from a possible interaction between calcitonin salmon and chlorobutanol, the preservative in the formulation. 

Calcitonin salmon Fortical (Unigene Labs) Postmenopausal osteoporosis... 

MIACALCIN nasal spray Novartis (U.S.) Calcitonin-salmon 32 amino acids, Mr = 3527 BKC 0.1 mg/mL, NaCI 8.5 mg/mL, HCI, N2 Glass bottles, screw-on pump 90 pL per actuation... 

PPL Therapeutics Bile human gastric Lipase, Fibrinogen, thrombin, Factor VII, Factor IX, alpha-antitrypsin, calcitonin (salmon), collagen, superoxide dismutase, Glucagon lipopeptide, Human serum albumin, Protein C 59-63... 

Calcitonin therapy requires the concomitant oral administration of elemental calcium (500 mg/day). Clinical studies have shown that the combination of intranasal calcitonin salmon (200 lU/day), oral calcium supplementation (>1,000 mg/day of elemental calcium), and vitamin D (400 lU/day) has decreased the rate of new fractures by more than 75% and has improved vertebral BMD by as much as 3% annually (3). Calcitonin prevents the abnormal bone turnover characteristic of Paget s disease of the bone and has antiresorptive activity. In the presence of calcitonin, the osteoclast brush borders disappear, and the osteoclasts move away from the bone surface undergoing remodeling (36). Side effects are significantly more pronounced when calcitonin-salmon Is administered by injection and can include nausea, vomiting, anorexia, and flushing. Because calcitonin-salmon Is protein in nature, the possibility of a systemic allergic reaction should be considered. 

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