PREGABALIN CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
24-03-2020
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
PREGABALIN
Tillgänglig från:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kod:
N02BF02
INN (International namn):
PREGABALIN
Dos:
25MG
Läkemedelsform:
CAPSULE
Sammansättning:
PREGABALIN 25MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS ANTICONVULSANTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0151121001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2013-11-07
Produktens egenskaper
_ _
_Pr_
_RAN_
_™_
_-PREGABALIN (Pregabalin Capsules) Product Monograph_
_ _
_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
Läs hela dokumentet
