PHL-ALENDRONATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-10-2012
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM)
Available from:
PHARMEL 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:
4/30
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0150323002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-10-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PHL-ALENDRONATE
Alendronic Acid Tablets, USP
Alendronic Acid 70 mg (as Alendronate Sodium)
Bone Metabolism Regulator
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
October 16, 2012
Submission Control No: 159326
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_phl-ALENDRONATE Product Monograph _
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_Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
12
OVERDOSAGE
.................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 14
STORAGE AND STABILITY
..........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 18
PART II: SCIENTIFIC INFORMATION
................................................................................
19
PHARMACEUTICAL INFORMATION
..........................................................................
19
CLINICAL TRIALS
..........................................................................................................
20
DETAILED PHARMACOLOGY
.
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