MINT-PREGABALIN CAPSULE
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
22-09-2021
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ingredients actius:
PREGABALIN
Disponible des:
MINT PHARMACEUTICALS INC
Codi ATC:
N02BF02
Designació comuna internacional (DCI):
PREGABALIN
Dosis:
50MG
formulario farmacéutico:
CAPSULE
Composición:
PREGABALIN 50MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
MISCELLANEOUS ANTICONVULSANTS
Resumen del producto:
Active ingredient group (AIG) number: 0151121002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2014-05-02
Fitxa tècnica
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_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 _
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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