CALCITONIN (SALMON) INJECTION, BP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCITONIN (SALMON SYNTHETIC)

Available from:

STERIMAX INC

ATC code:

H05BA01

INN (International Name):

CALCITONIN (SALMON SYNTHETIC)

Dosage:

200UNIT

Pharmaceutical form:

SOLUTION

Composition:

CALCITONIN (SALMON SYNTHETIC) 200UNIT

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PARATHYROID AND ANTIPARATHYROID AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-02-20

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
CALCITONIN (SALMON) INJECTION, BP
400 IU / 2 ML (200 IU / ML)
STERILE SOLUTION FOR INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
SYNTHETIC SALMON CALCITONIN
CALCIUM REGULATOR
Submission Control No.: 271424
Date of
Preparation:
FEB 15, 2023
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
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PRODUCT MONOGRAPH
Pr
Calcitonin (Salmon) Injection, BP
400 IU / 2 mL (200 IU / mL)
THERAPEUTIC CLASSIFICATION
Synthetic salmon calcitonin
Calcium Regulator
ACTIONS
Calcitonin participates in the regulation of the homeostasis of
calcium by acting primarily on the
bone: in Paget's disease presumably by an initial blocking effect on
accelerated bone resorption.
The rate of bone turnover appears to be decreased.
Calcitonin
participates
in
the
regulation
of
urinary
excretion
of
phosphate
and
calcium.
Administration of calcitonin decreases the volume and acidity of the
gastric juice and decreases the
volume as well as trypsin and amylase content of the pancreatic juice.
(For further details see CLINICAL PHARMACOLOGY section).
INDICATIONS
1) Paget's Disease
Treatment of symptomatic Paget's disease only in patients who do not
respond to alternative
treatments or for whom such treatments are not suitable.
2) Hypercalcemia
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 also may be added to existing therapeutic regimens
for hypercalcemia such as
intravenous fluids and furosemide, oral phosphate or corticosteroids,
or other agents. Calcitonin may
be used in patients with azotemia and those with limited cardiac
reserve in whom intravenous fluids
may be contraindicated.
Due to evidence of an increased risk of malignancies with the
long-term calcitonin use, the treatment
duration should be limited to the shortest period of time possible and
using the minimum effective
dose.
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CONTRAINDICATIONS
Patients who are hypersensitive to this drug or to