DILANTIN CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PHENYTOIN SODIUM

可用日期:

BGP PHARMA ULC

ATC代码:

N03AB02

INN（国际名称）:

PHENYTOIN

剂量:

30MG

药物剂型:

CAPSULE

组成:

PHENYTOIN SODIUM 30MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

HYDANTOINS

產品總結:

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

授权状态:

APPROVED

授权日期:

2023-06-07

产品特点

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