DILANTIN CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

PHENYTOIN SODIUM

Dostopno od:

BGP PHARMA ULC

Koda artikla:

N03AB02

INN (mednarodno ime):

PHENYTOIN

Odmerek:

30MG

Farmacevtska oblika:

CAPSULE

Sestava:

PHENYTOIN SODIUM 30MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

HYDANTOINS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-06-07

Lastnosti izdelka

_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
..........................