TEGRETOL CHEWTABS 200 MG TABLET (CHEWABLE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CARBAMAZEPINE

Disponível em:

NOVARTIS PHARMACEUTICALS CANADA INC

Código ATC:

N03AF01

DCI (Denominação Comum Internacional):

CARBAMAZEPINE

Dosagem:

200MG

Forma farmacêutica:

TABLET (CHEWABLE)

Composição:

CARBAMAZEPINE 200MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANTICONVULSANTS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2017-09-26

Características técnicas

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_Page 1 of 46_
PRODUCT MONOGRAPH
PR
TEGRETOL
®
(carbamazepine)
Pr
TEGRETOL
®
Tablets, 200 mg
Novartis Standard
Pr
TEGRETOL
®
Chewtabs (Chewable Tablets), 100 mg and 200 mg
Novartis Standard
Pr
TEGRETOL
®
CR (Controlled-Release Tablets), 200 mg and 400 mg
Novartis Standard
Pr
TEGRETOL
®
Suspension, 100 mg/tsp (5 mL)
Novartis Standard
Anticonvulsant
For Symptomatic Relief of Trigeminal Neuralgia
Antimanic
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
Dorval, Quebec
H9S 1A9
Date of Preparation:
April 26, 1976
Date of Revision:
May 4, 2018
Submission Control No: 213356
TEGRETOL
is a registered trademark.
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_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................16
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...................................