GABAPENTIN CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

GABAPENTIN

Dostopno od:

SIVEM PHARMACEUTICALS ULC

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:

APPROVED

Datum dovoljenje:

2012-06-01

Lastnosti izdelka

_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
......