TEVA-ALENDRONATE/CHOLECALCIFEROL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-07-2017
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM); VITAMIN D3 (CHOLECALCIFEROL)
Available from:
TEVA CANADA LIMITED
ATC code:
M05BB03
INN (International Name):
ALENDRONIC ACID AND CHOLECALCIFEROL
Dosage:
70MG; 2800UNIT
Pharmaceutical form:
TABLET
Composition:
ALENDRONIC ACID (ALENDRONATE SODIUM) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 2800UNIT
Administration route:
ORAL
Units in package:
4
Prescription type:
Prescription
Therapeutic area:
VITAMIN D
Product summary:
Active ingredient group (AIG) number: 0251575001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-03-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
PR
TEVA-ALENDRONATE/CHOLECALCIFEROL
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 24, 2017
Toronto, Ontario
M1B 2K9
Canada
Submission Control No: 207329
2
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
..........................................................................
16
OVERDOSAGE
............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 17
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
......................................................................
24
CLINICAL TRIALS
.....................................
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