NEURONTIN CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

GABAPENTIN

זמין מ:

BGP PHARMA ULC

קוד ATC:

N02BF01

INN (שם בינלאומי):

GABAPENTIN

כמות:

100MG

טופס פרצבטיות:

CAPSULE

הרכב:

GABAPENTIN 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2001-01-05

מאפייני מוצר

_NEURONTIN (gabapentin) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NEURONTIN®
Gabapentin Capsules
Capsules, 100 mg, 300 mg and 400 mg, oral
Gabapentin Tablets
Tablets, 600 mg and 800 mg, oral
Antiepileptic Agent
BGP Pharma ULC
85 Advance Road
Etobicoke (Ontario)
Canada M8Z 2S6
Date of Initial Approval:
MAY 05, 2023
Date of Revision:
OCTOBER 16, 2023
Submission Control No: 275525
®
Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
© BGP Pharma ULC, 2023
_ _
_NEURONTIN (gabapentin) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
10-2023
7.1 Special Populations, 7.1.1 Pregnant Women, Neonatal
withdrawal syndrome
02-2023
7.1 Special Populations, 7.1.1 Pregnant Women, Women of
childbearing potential/Contraception
10-2023
7.1 Special Populations, 7.1.1 Pregnant Women, Teratogenic
Potential
10-2023
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
......................