TARO-GABAPENTIN CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Kauptu það núna

Download Vara einkenni (SPC)
16-12-2020

Virkt innihaldsefni:

GABAPENTIN

Fáanlegur frá:

TARO PHARMACEUTICALS INC

ATC númer:

N02BF01

INN (Alþjóðlegt nafn):

GABAPENTIN

Skammtar:

100MG

Lyfjaform:

CAPSULE

Samsetning:

GABAPENTIN 100MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

MISCELLANEOUS ANTICONVULSANTS

Vörulýsing:

Active ingredient group (AIG) number: 0125929001; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2023-11-08

Vara einkenni

                                _ _
_Taro-Gabapentin Product Monograph _
_Page 1 of 30_
PRODUCT MONOGRAPH
Pr
TARO-GABAPENTIN
Gabapentin
Capsules 100 mg, 300 mg and 400 mg
Antiepileptic Agent
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision: December
16, 2020
Submission Control No: 245306
_ _
_Taro-Gabapentin Product Monograph _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
..............................................................................
21
PHARMACEUTICAL INFORMATION
.........................................................................
21
CLINICAL TRIALS
.........................................................................................................
21
DETAILED PHARMACOLOGY
........
                                
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