GEN-ALENDRONATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-04-2006
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Active ingredient:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE)
Available from:
GENPHARM ULC
ATC code:
M05BA04
INN (International Name):
ALENDRONIC ACID
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
ALENDRONIC ACID (ALENDRONATE SODIUM TRIHYDRATE) 5MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
BONE RESORPTION INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0150323004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2009-08-05
Summary of Product characteristics
PRODUCT MONOGRAPH
GEN-ALENDRONATE
(Alendronate Sodium Tablets, House Standard)
5 mg and 10 mg
Alendronic Acid
Bone Metabolism Regulator
Genpharm Inc.
85 Advance Road,
Etobicoke, Ontario
M8Z 2S6
Submission control number:
100976
Date of Preparation:
August 22, 2005
Date of Revision:
January 25, 2006
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Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINAL
USE.................................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND
STABILITY.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL
INFORMATION.........................................................................
19
CLINICAL
TRIALS.........................................................................................................
19
DETAILED
PHARMACOLOGY.................................................
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