GABAPENTIN CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

GABAPENTIN

Dostępny od:

SIVEM PHARMACEUTICALS ULC

Kod ATC:

N02BF01

INN (International Nazwa):

GABAPENTIN

Dawkowanie:

100MG

Forma farmaceutyczna:

CAPSULE

Skład:

GABAPENTIN 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTICONVULSANTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-06-01

Charakterystyka produktu

_Product Monograph GABAPENTIN_
_Page 1 of 30_
_ _
PRODUCT MONOGRAPH
PR
GABAPENTIN
Gabapentin Capsules
(Manufacturer’s Standard)
100 mg, 300 mg and 400 mg
ANTIEPILEPTIC AGENT
Sivem Pharmaceuticals ULC
4705 Dobrin Street,
Saint-Laurent, Quebec
H4R 2P7
www.sivem.ca
Date of Revision:
August 20, 2020
Submission Control No.: 242233
_Product Monograph GABAPENTIN_
_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
....................................................................
17
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
......