APO-ALENDRONATE/VITAMIN D3 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-10-2017
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM); VITAMIN D3 (CHOLECALCIFEROL)
Available from:
APOTEX INC
ATC code:
M05BB03
INN (International Name):
ALENDRONIC ACID AND CHOLECALCIFEROL
Dosage:
70MG; 5600UNIT
Pharmaceutical form:
TABLET
Composition:
ALENDRONIC ACID (ALENDRONATE SODIUM) 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:
APPROVED
Authorization date:
2016-05-03
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
APO-ALENDRONATE / VITAMIN D
3
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
and
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE OCTOBER 3, 2017
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 209085
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
...........................................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................17
STORAGE AND STABILITY
....................................................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................................22
PART II: SCIE
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