APO-CARBAMAZEPINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CARBAMAZEPINE

Dostopno od:

APOTEX INC

Koda artikla:

N03AF01

INN (mednarodno ime):

CARBAMAZEPINE

Odmerek:

200MG

Farmacevtska oblika:

TABLET

Sestava:

CARBAMAZEPINE 200MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0108674001; AHFS:

Status dovoljenje:

MARKETED

Datum dovoljenje:

1980-12-31

Lastnosti izdelka

_APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _
_Page 1 of 52 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CARBAMAZEPINE
Carbamazepine Tablets
Tablets, 200 mg, oral
USP
PR
APO-CARBAMAZEPINE CR
Carbamazepine Controlled Release Tablets
Controlled-Release Tablets, 200 mg and 400 mg, oral
Apotex Standard
Anticonvulsant
For Symptomatic Relief of Trigeminal Neuralgia
Antimanic
ATC code: N03AF01
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 10, 1980
Date of Revision:
May 31, 2022
Submission Control Number: 262869
_APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _
_Page 2 of 52 _
_ _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................4
1
INDICATIONS
.......................................................................................................................4
1.1
Pediatrics
.....................................................................................................................
5
1.2
Geriatrics......................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX......................................................................6
4
DOSAGE AND ADMINISTRATION
..........................................................................................7
4.1
Dosing Considerations
..................................................................................................
7
4.2
Recommended Dose and Dosage
Adjustment...........................................