PREGABALIN CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PREGABALIN

Saatavilla:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-koodi:

N02BF02

INN (Kansainvälinen yleisnimi):

PREGABALIN

Annos:

25MG

Lääkemuoto:

CAPSULE

Koostumus:

PREGABALIN 25MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151121001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-11-07

Valmisteyhteenveto

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_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
RAN
™
-PREGABALIN
Pregabalin Capsules
25 mg, 50 mg, 75 mg, 150 mg, 225 mg, 300 mg
ANALGESIC AGENT
Ranbaxy Pharmaceuticals Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
March 24, 2020
Submission Control No: 237057
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
_ _
_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
.................................................................................................4
ADVERSE REACTIONS
..................................................................................................15
DRUG INTERACTIONS
................................................................................................33
DOSAGE AND ADMINISTRATION
...........................................................................35
OVERDOSAGE
...............................................................................................................37
ACTION AND CLINICAL PHARMACOLOGY
............................................................38
STORAGE AND
STABILITY........................................................................................41
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................41
PART II: SCIENTIFIC INFORMATION
...............................................................................43
PHARMACEUTICAL INFORMATION
..........................................................................43
CLINICAL TRIALS
........................................................................................................44
D