APO-CALCITONIN NASAL SPRAY SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CALCITONIN (SALMON SYNTHETIC)

Mevcut itibaren:

APOTEX INC

ATC kodu:

H05BA01

INN (International Adı):

CALCITONIN (SALMON SYNTHETIC)

Doz:

200UNIT

Farmasötik formu:

SOLUTION

Kompozisyon:

CALCITONIN (SALMON SYNTHETIC) 200UNIT

Uygulama yolu:

NASAL

Paketteki üniteler:

2ML

Reçete türü:

Prescription

Terapötik alanı:

PARATHYROID AND ANTIPARATHYROID AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2013-10-01

Ürün özellikleri

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