RAN-GABAPENTIN CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
17-06-2020
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Aktivna sestavina:
GABAPENTIN
Dostopno od:
RANBAXY PHARMACEUTICALS CANADA INC.
Koda artikla:
N02BF01
INN (mednarodno ime):
GABAPENTIN
Odmerek:
100MG
Farmacevtska oblika:
CAPSULE
Sestava:
GABAPENTIN 100MG
Pot uporabe:
ORAL
Enote v paketu:
100/500
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTICONVULSANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0125929001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2023-02-06
Lastnosti izdelka
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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