DILANTIN INFATABS TABLET (CHEWABLE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

PHENYTOIN

Disponível em:

BGP PHARMA ULC

Código ATC:

N03AB02

DCI (Denominação Comum Internacional):

PHENYTOIN

Dosagem:

50MG

Forma farmacêutica:

TABLET (CHEWABLE)

Composição:

PHENYTOIN 50MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

HYDANTOINS

Resumo do produto:

Active ingredient group (AIG) number: 0101372003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2023-08-02

Características técnicas

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_DILANTIN INFATABS and DILANTIN SUSPENSIONS (phenytoin) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DILANTIN® INFATABS
Phenytoin Chewable Tablets
chewable tablets, 50 mg, oral
USP
PR
DILANTIN®
- 30 SUSPENSION
PR
DILANTIN®
- 125 SUSPENSION
Phenytoin Oral Suspension
solutions, 30 mg / 5 mL and 125 mg / 5 mL, oral
USP
Anticonvulsant
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
August 2, 2023
Submission Control Number: 277167
® Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
© BGP Pharma ULC, 2023
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_DILANTIN INFATABS and DILANTIN SUSPENSIONS (phenytoin) _
_Page 2 of 39_
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
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
...........................