APO-CALCITONIN NASAL SPRAY SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCITONIN (SALMON SYNTHETIC)

Available from:

APOTEX INC

ATC code:

H05BA01

INN (International Name):

CALCITONIN (SALMON SYNTHETIC)

Dosage:

200UNIT

Pharmaceutical form:

SOLUTION

Composition:

CALCITONIN (SALMON SYNTHETIC) 200UNIT

Administration route:

NASAL

Units in package:

2ML

Prescription type:

Prescription

Therapeutic area:

PARATHYROID AND ANTIPARATHYROID AGENTS

Product summary:

Active ingredient group (AIG) number: 0111011001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-10-01

Summary of Product characteristics

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