PREGABALIN CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PREGABALIN

Commercializzato da:

RANBAXY PHARMACEUTICALS CANADA INC.

Codice ATC:

N02BF02

INN (Nome Internazionale):

PREGABALIN

Dosaggio:

25MG

Forma farmaceutica:

CAPSULE

Composizione:

PREGABALIN 25MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-11-07

Scheda tecnica

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_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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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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_RAN_
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_-PREGABALIN (Pregabalin Capsules) Product Monograph_
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_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