MINT-PREGABALIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-09-2021
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Active ingredient:
PREGABALIN
Available from:
MINT PHARMACEUTICALS INC
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: 0151121003; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-05-02
Summary of Product characteristics
______________________________________________________________________________
_Mint-Pregabalin Product Monograph _
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PRODUCT MONOGRAPH
PR
MINT-PREGABALIN
Pregabalin Capsules
Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300
mg
ANALGESIC AGENT
Mint Pharmaceuticals Inc.
6575 Davand Dr
Mississauga, Ontario, Canada
L5T 2M3
SUBMISSION CONTROL NUMBER: 255444
DATE OF PREPARATION:
September 22, 2021
______________________________________________________________________________
_Mint-Pregabalin Product Monograph _
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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..................................................................................................34
DOSAGE AND ADMINISTRATION
.............................................................................36
OVERDOSAGE................................................................................................................39
ACTION AND CLINICAL
PHARMACOLOGY............................................................40
STORAGE AND
STABILITY..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................43
PART II: SCIENTIFIC
INFORMATION................................................................................45
PHARMACEUTICAL
INFORMATION.......................................
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