RAN-GABAPENTIN CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
17-06-2020
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Aktiva substanser:
GABAPENTIN
Tillgänglig från:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kod:
N02BF01
INN (International namn):
GABAPENTIN
Dos:
300MG
Läkemedelsform:
CAPSULE
Sammansättning:
GABAPENTIN 300MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS ANTICONVULSANTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0125929003; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2023-02-06
Produktens egenskaper
Page 1 of 33
PRODUCT MONOGRAPH
PR
RAN™-GABAPENTIN
Gabapentin Capsules, Mfr. Std
100 mg, 300 mg, and 400 mg
Antiepileptic Agent
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision
126 East Drive
June 17, 2020
Brampton, Ontario
L6T 1C1
Submission Control No.: 239409
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
15
OVERDOSAGE
........................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
17
STORAGE AND STABILITY
.................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
...................................
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