FOSAVANCE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

ORGANON 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:

15G/50G

Prescription type:

Prescription

Therapeutic area:

VITAMIN D

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2008-08-08

Summary of Product characteristics

_FOSAVANCE_
_®_
_ (alendronate sodium_
_/cholecalciferol_
_) _
_Page 1 of 52_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FOSAVANCE®
alendronate sodium / cholecalciferol
Tablet, 70 mg / 70 mcg (2800 IU), Oral
FOSAVANCE®
alendronate sodium / cholecalciferol
Tablet, 70 mg / 140 mcg (5600 IU), Oral
Bone Metabolism Regulator and Vitamin D
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Initial Authorization:
FEB 04, 2002
Date of Revision:
AUG 03, 2023
Submission Control Number: 273858
_ _
_FOSAVANCE_
_®_
_ (alendronate sodium_
_/cholecalciferol_
_) _
_Page 2 of 52_
RECENT MAJOR LABEL CHANGES
Warnings and Precautions
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
................