DILANTIN CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PHENYTOIN SODIUM

Disponibil de la:

BGP PHARMA ULC

Codul ATC:

N03AB02

INN (nume internaţional):

PHENYTOIN

Dozare:

30MG

Forma farmaceutică:

CAPSULE

Compoziție:

PHENYTOIN SODIUM 30MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

HYDANTOINS

Rezumat produs:

Active ingredient group (AIG) number: 0101375001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2023-06-07

Caracteristicilor produsului

_DILANTIN (phenytoin sodium) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DILANTIN®
Extended Phenytoin Sodium Capsules
capsules, 30 mg and 100 mg, oral
USP
Anticonvulsant
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control Number: 275242
® Viatris Specialty LLC
BGP Pharma ULC, a Viatris company, Licensee
© BGP Pharma ULC, 2023
Date of Initial Authorization:
JUN
07, 2023
_DILANTIN (phenytoin sodium) _
_Page 2 of 38_
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
......................................................... 5
4.5
Missed Dose
..............................................................................................................
6
5
OVERDOSAGE
..........................