MINT-PREGABALIN CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PREGABALIN

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

N02BF02

INN (Internationale Bezeichnung):

PREGABALIN

Dosierung:

100MG

Darreichungsform:

CAPSULE

Zusammensetzung:

PREGABALIN 100MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30/1000

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS ANTICONVULSANTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0151121004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2014-05-02

Fachinformation

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