DOM-PREGABALIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-03-2017
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Active ingredient:
PREGABALIN
Available from:
DOMINION PHARMACAL
ATC code:
N02BF02
INN (International Name):
PREGABALIN
Dosage:
75MG
Pharmaceutical form:
CAPSULE
Composition:
PREGABALIN 75MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0151121011; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-03-18
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
DOM-PREGABALIN
Pregabalin capsules
25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg
ANALGESIC AGENT
DOMINION PHARMACAL
6111 Av. Royalmount, Suite 100
June 02, 2009
Montréal, Quebec
H4P 2T4
Date of Revision:
March 20, 2017
Submission Control No.: 203283
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_Dom-PREGABALIN Product Monograph _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
36
DOSAGE AND ADMINISTRATION
.............................................................................
38
OVERDOSAGE
...............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 42
STORAGE AND STABILITY
.........................................................................................
45
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 45
PART II: SCIENTIFIC INFORMATION
..............................................................................
47
PHARMACEUTICAL INFORMATION
.........................................................................
47
CLINICAL TRIALS
.........................................................................................................
48
DETAILED PHARMACOLOGY
...............................
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