ALENDRONATE-CHOLECALCIFEROL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE); VITAMIN D3 (CHOLECALCIFEROL)

Available from:

FROSST A DIVISION OF MERCK CANADA INC

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:

4/12/20

Prescription type:

Prescription

Therapeutic area:

VITAMIN D

Product summary:

Active ingredient group (AIG) number: 0251575002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2016-05-05

Summary of Product characteristics

_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
PRODUCT MONOGRAPH
ALENDRONATE-CHOLECALCIFEROL 70/2800
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 70 MCG CHOLECALCIFEROL (2800 IU VITAMIN D
3
)
ALENDRONATE-CHOLECALCIFEROL 70/5600
alendronate sodium/cholecalciferol tablets
70 MG ALENDRONATE + 140 MCG CHOLECALCIFEROL (5600 IU VITAMIN D
3
)
Bone Metabolism Regulator and Vitamin D
FROSST, A DIVISION OF MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
DATE OF REVISION:
APRIL 25, 2016
www.merck.ca
SUBMISSION CONTROL NO:
193513
_ALENDRONATE-CHOLECALCIFEROL _
_(alendronate sodium/cholecalciferol)_
_Page 2 of 44_
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
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...................