Land: Canada
Taal: Engels
Bron: Health Canada
CALCITONIN (SALMON SYNTHETIC)
APOTEX INC
H05BA01
CALCITONIN (SALMON SYNTHETIC)
200UNIT
SOLUTION
CALCITONIN (SALMON SYNTHETIC) 200UNIT
NASAL
2ML
Prescription
PARATHYROID AND ANTIPARATHYROID AGENTS
Active ingredient group (AIG) number: 0111011001; AHFS:
CANCELLED POST MARKET
2013-10-01
PRODUCT MONOGRAPH APO-CALCITONIN NASAL SPRAY Calcitonin (Salmon) Nasal Solution 200 IU/spray Bone Metabolism Regulator Apotex Inc. DATE OF PREPARATION: 150 Signet Drive September 2, 2003 Weston, Ontario M9L 1T9 Control # 079397 - 1 - PRODUCT MONOGRAPH APO-CALCITONIN NASAL SPRAY Calcitonin (Salmon) Nasal Solution 200 IU/spray THERAPEUTIC CLASSIFICATION Bone Metabolism Regulator ACTIONS AND CLINICAL PHARMACOLOGY Salmon calcitonin (s-Calcitonin) is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. It is of physiological importance in the regulation of calcium metabolism in certain animal species and may also have physiological importance in certain extraskeletal systems (e.g., GI and renal function). All calcitonin structures consist of 32 amino acids in a single chain, with a ring of seven amino- acid residues at the N-terminus, the sequence of which differs from species to species. Calcitonin (salmon) nasal solution is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. Due to the greater affinity of salmon calcitonin to receptor binding sites than calcitonins from mammalian species, including the synthetic human calcitonin, calcitonin (salmon) nasal solution is more potent and longer acting. In terms of bioactivity, the potency of calcitonin (salmon) nasal solution was found to be about half that of the drug given by i.m. or s.c. injection. Osteoporosis is a disease characterized by low bone mass and deterioration of bone tissue architecture leading to enhanced bone fragility and consequent increase in fracture risk. The most common type of osteoporosis occurs in postmenopausal females. Osteoporosis is a result of a disproportionate rate of bone resorption compared to bone formation which disrupts the structural integrity of bone, rendering it more susceptible to fracture. The most common sites of these fractures are the vertebrae, hip, and distal forearm (Co Lees het volledige document