M-ALENDRONATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ALENDRONIC ACID (ALENDRONATE SODIUM)

Available from:

MANTRA PHARMA INC

ATC code:

M05BA04

INN (International Name):

ALENDRONIC ACID

Dosage:

70MG

Pharmaceutical form:

TABLET

Composition:

ALENDRONIC ACID (ALENDRONATE SODIUM) 70MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0150323002; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-07-22

Summary of Product characteristics

_M-Alendronate (alendronate sodium tablets) Product Monograph _
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_Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-ALENDRONATE
Alendronate Sodium Tablets
Tablet, 5 mg, 10 mg and 70 mg, Oral
House Standard
Bone Metabolism Regulator
Mantra Pharma Inc.
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3
Date of Initial Authorization:
JUL 21, 2022
Submission Control Number: 263263
_M-Alendronate (alendronate sodium tablets) Product Monograph _
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_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
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5
4.5
Missed Dose
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6
5
OVERDOSA