MINT-GABAPENTIN CAPSULE

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

GABAPENTIN

Prieinama:

MINT PHARMACEUTICALS INC

ATC kodas:

N02BF01

INN (Tarptautinis Pavadinimas):

GABAPENTIN

Dozė:

300MG

Vaisto forma:

CAPSULE

Sudėtis:

GABAPENTIN 300MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/500

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS ANTICONVULSANTS

Produkto santrauka:

Active ingredient group (AIG) number: 0125929003; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2013-07-17

Prekės savybės

_MINT-GABAPENTIN (gabapentin) _
_Page 1 of 37_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-GABAPENTIN
Gabapentin Capsules
Capsules, 100 mg, 300 mg and 400 mg, oral
Manufacturer’s Standard
Antiepileptic Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Date of Initial Authorization:
JUL 17, 2013
Date of Revision:
SEP 12, 2023
Submission Control No: 274086
_MINT-GABAPENTIN (gabapentin) _
_Page 2 of 37_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
09-2023
7.1 Special Populations, 7.1.1 Pregnant Women, Neonatal
withdrawal syndrome
09-2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 4
4
DOSAGE AND ADMINISTRATION
....................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..........................