TARO-PHENYTOIN CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PHENYTOIN SODIUM

Boleh didapati daripada:

TARO PHARMACEUTICALS INC

Kod ATC:

N03AB02

INN (Nama Antarabangsa):

PHENYTOIN

Dos:

100MG

Borang farmaseutikal:

CAPSULE

Komposisi:

PHENYTOIN SODIUM 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100/1000

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HYDANTOINS

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2022-06-27

Ciri produk

_Taro- Phenytoin (Extended Phenytoin Sodium Capsules) Page 1 of 29 _
_Product Monograph _
PRODUCT MONOGRAPH
PR
TARO-PHENYTOIN
Extended Phenytoin Sodium Capsules
100 mg
Taro Standard ANTICONVULSANT
Taro Pharmaceuticals Inc.
DATE OF REVISION: November 07, 2019
130 East Drive, Brampton
Ontario L6T 1C1
SUBMISSION CONTROL NO: 231717
_Taro- Phenytoin (Extended Phenytoin Sodium Capsules) Page 2 of 29 _
_Product Monograph _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................................
3
CONTRAINDICATIONS
.....................................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................................
4
ADVERSE REACTIONS
...................................................................................................................
12
DRUG INTERACTIONS
....................................................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................................................
17
OVERDOSAGE....................................................................................
ERROR! BOOKMARK NOT DEFINED.
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
20
STORAGE AND STABILITY
............................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................. 21
PART II: SCIENTIFIC INFORMATION
..................................................................