SANDOZ-CALCITONIN NS LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CALCITONIN (SALMON SYNTHETIC)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

H05BA01

INN (International Name):

CALCITONIN (SALMON SYNTHETIC)

Dosage:

200UNIT

Pharmaceutical form:

LIQUID

Composition:

CALCITONIN (SALMON SYNTHETIC) 200UNIT

Administration route:

NASAL

Units in package:

200 U.I / SPRAY BOTTLE

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

Sandoz Calcitonin NS
Page 1 of 35
PRODUCT MONOGRAPH
PR
SANDOZ CALCITONIN NS
Synthetic Calcitonin (Salmon)
Nasal Spray
200 IU/actuation
Bone Metabolism Regulator
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
October 12, 2010
Boucherville, Quebec
J4B-7K8
Control number : 140901
Sandoz Calcitonin NS
Page 2 of 35
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................3
SUMMARY PRODUCT
INFORMATION.............................................................................3
INDICATIONS AND CLINICAL
USE...................................................................................3
CONTRAINDICATIONS........................................................................................................4
WARNINGS AND
PRECAUTIONS......................................................................................4
ADVERSE
REACTIONS........................................................................................................5
DRUG
INTERACTIONS........................................................................................................10
DOSAGE AND
ADMINISTRATION....................................................................................11
OVERDOSAGE
……………………………………………………………………….........12
ACTION AND CLINICAL
PHARMACOLOGY..................................................................12
STORAGE AND
STABILITY...............................................................................................15
SPECIAL HANDLING
INSTRUCTIONS............................................................................15
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................15
PART II: SCIENTIFIC
INFORMATION..........................................................................16
PHARMACEUTICAL
INFORMATION...............................................................................16
CLINICAL
TRIALS....................................................