MINT-PREGABALIN CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PREGABALIN

Commercializzato da:

MINT PHARMACEUTICALS INC

Codice ATC:

N02BF02

INN (Nome Internazionale):

PREGABALIN

Dosaggio:

225MG

Forma farmaceutica:

CAPSULE

Composizione:

PREGABALIN 225MG

Via di somministrazione:

ORAL

Confezione:

30/1000

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0151121007; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2014-05-02

Scheda tecnica

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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
______________________________________________________________________________
_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.......................................