DILANTIN CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PHENYTOIN SODIUM

Διαθέσιμο από:

BGP PHARMA ULC

Φαρμακολογική κατηγορία (ATC):

N03AB02

INN (Διεθνής Όνομα):

PHENYTOIN

Δοσολογία:

30MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

PHENYTOIN SODIUM 30MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HYDANTOINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-06-07

Αρχείο Π.Χ.Π.

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