ALENDRONATE-CHOLECALCIFEROL TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

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

MAH:

FROSST A DIVISION OF MERCK CANADA INC

ATC_code:

M05BB03

INN:

ALENDRONIC ACID AND CHOLECALCIFEROL

dosage:

70MG; 2800UNIT

pharmaceutical_form:

TABLET

composition:

ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 70MG; VITAMIN D3 (CHOLECALCIFEROL) 2800UNIT

administration_route:

ORAL

units_in_package:

4

prescription_type:

Prescription

therapeutic_area:

VITAMIN D

leaflet_short:

Active ingredient group (AIG) number: 0251575001; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2016-05-05

SPC

_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
...................