MINT-PREGABALIN CAPSULE
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-09-2021
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Aktiv ingrediens:
PREGABALIN
Tilgjengelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N02BF02
INN (International Name):
PREGABALIN
Dosering :
50MG
Legemiddelform:
CAPSULE
Sammensetning:
PREGABALIN 50MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTICONVULSANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0151121002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2014-05-02
Preparatomtale
______________________________________________________________________________
_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
______________________________________________________________________________
_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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