MINT-PREGABALIN CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
22-09-2021
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Werkstoffen:
PREGABALIN
Beschikbaar vanaf:
MINT PHARMACEUTICALS INC
ATC-code:
N02BF02
INN (Algemene Internationale Benaming):
PREGABALIN
Dosering:
100MG
farmaceutische vorm:
CAPSULE
Samenstelling:
PREGABALIN 100MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/1000
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS ANTICONVULSANTS
Product samenvatting:
Active ingredient group (AIG) number: 0151121004; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-05-02
Productkenmerken
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_Mint-Pregabalin Product Monograph _
1 of 64
_ _
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
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_Mint-Pregabalin Product Monograph _
2 of 64
_ _
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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