PREGABALIN CAPSULE

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

PREGABALIN

Disponibbli minn:

RANBAXY PHARMACEUTICALS CANADA INC.

Kodiċi ATC:

N02BF02

INN (Isem Internazzjonali):

PREGABALIN

Dożaġġ:

300MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

PREGABALIN 300MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151121008; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-11-07

Karatteristiċi tal-prodott

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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.
_ _
_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