SANDOZ ALENDRONATE/CHOLECALCIFEROL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
28-07-2017
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
M05BB03
INN (International Name):
ALENDRONIC ACID AND CHOLECALCIFEROL
Dosage:
70MG; 5600UNIT
Pharmaceutical form:
TABLET
Composition:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 5600UNIT
Administration route:
ORAL
Units in package:
4
Prescription type:
Prescription
Therapeutic area:
VITAMIN D
Product summary:
Active ingredient group (AIG) number: 0251575002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2023-07-28
Summary of Product characteristics
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_Sandoz Alendronate/Cholecalciferol _
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PRODUCT MONOGRAPH
Pr
SANDOZ ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 mg alendronate (as alendronate sodium) + 140 mcg cholecalciferol
(5600 IU vitamin D
3
)
Bone Metabolism Regulator and Vitamin D
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Québec
J4B 7K8
Date of Revision:
July 18, 2017
Submission Control No: 206959
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_Sandoz Alendronate/Cholecalciferol. _
_Page 2 of 46_
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
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.........................................................................
24
CLINICAL TRIALS
.........
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