TRILEPTAL ORAL SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

OXCARBAZEPINE

זמין מ:

NOVARTIS PHARMACEUTICALS CANADA INC

קוד ATC:

N03AF02

INN (שם בינלאומי):

OXCARBAZEPINE

כמות:

60MG

טופס פרצבטיות:

SUSPENSION

הרכב:

OXCARBAZEPINE 60MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

250 ML

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0140461004; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2001-10-12

מאפייני מוצר

_Pr_
_TRILEPTAL_
_® _
_Oxcarbazepine _
_Page 1 of 69_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRILEPTAL
®
Oxcarbazepine
Tablets, 300 mg and 600 mg, oral
Novartis Standard
Oral Suspension, 60 mg/mL, oral
Antiepileptic
ATC code: N03AF02
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization :
Apr 06, 2000
Date of Revision:
June 4, 2021
Submission Control Number: 247670
TRILEPTAL is a registered trademark.
_ _
_TRILEPTAL Oxcarbazepine _
_Page 2 of 69_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
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...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................6
4.4
Administration.....................................................................................................8
4.5
Missed Dose
........................................................................................................9
5
OVERDOSAGE
...........