PHENYTOIN SODIUM CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PHENYTOIN SODIUM

Disponible desde:

AA PHARMA INC

Código ATC:

N03AB02

Designación común internacional (DCI):

PHENYTOIN

Dosis:

100MG

formulario farmacéutico:

CAPSULE

Composición:

PHENYTOIN SODIUM 100MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

HYDANTOINS

Resumen del producto:

Active ingredient group (AIG) number: 0101375002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-02-26

Ficha técnica

_PHENYTOIN SODIUM (phenytoin sodium) _
_ _
_Page 1 of 44_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PHENYTOIN SODIUM
Extended Phenytoin Sodium Capsules
capsules, 100 mg, oral
House Standard
Anticonvulsant
AA Pharma Inc.
1165 Creditstone Road Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
JAN 26, 2017
Date of Revision:
DEC 10, 2022
Submission Control Number: 265640
_PHENYTOIN SODIUM (phenytoin sodium) _
_ _
_Page 2 of 44_
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RECENT MAJOR LABEL CHANGES
None at the time of most recent authorization.
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
4
DOSAGE AND
ADMINISTRATION.....................................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 6
4.5
Missed Dose
........................................................................................................
7
5
OVERDOSAGE..................................................