JAMP-ALENDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Available from:

JAMP PHARMA CORPORATION

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID (ALENDRONATE SODIUM) 10MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

BONE RESORPTION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0150323003; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-05-25

Summary of Product characteristics

_JAMP-Alendronate (alendronate sodium tablets) _
_Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-ALENDRONATE
Alendronate Sodium Tablets
Tablet, 5 mg, 10 mg and 70 mg, Oral
House Standard
Bone Metabolism Regulator
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
May 25, 2012
Date of Revision:
August 9, 2022
Submission Control Number:
265969
_JAMP-Alendronate (alendronate sodium tablets) _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
08/2022
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
........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.................................................................. 5
4.4
ADMINISTRATION....................................................................................................................
5
4.5
MISSED
DOSE.................................................................................................