RAN-GABAPENTIN CAPSULE
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
17-06-2020
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Aktívna zložka:
GABAPENTIN
Dostupné z:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC kód:
N02BF01
INN (Medzinárodný Name):
GABAPENTIN
Dávkovanie:
100MG
Forma lieku:
CAPSULE
Zloženie:
GABAPENTIN 100MG
Spôsob podávania:
ORAL
Počet v balení:
100/500
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS ANTICONVULSANTS
Prehľad produktov:
Active ingredient group (AIG) number: 0125929001; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2023-02-06
Súhrn charakteristických
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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