MINT-PREGABALIN CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

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Ladda ner Produktens egenskaper (SPC)
22-09-2021

Aktiva substanser:

PREGABALIN

Tillgänglig från:

MINT PHARMACEUTICALS INC

ATC-kod:

N02BF02

INN (International namn):

PREGABALIN

Dos:

100MG

Läkemedelsform:

CAPSULE

Sammansättning:

PREGABALIN 100MG

Administreringssätt:

ORAL

Enheter i paketet:

30/1000

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS ANTICONVULSANTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2014-05-02

Produktens egenskaper

                                ______________________________________________________________________________
_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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