DILANTIN CAPSULE
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
07-06-2023
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
PHENYTOIN SODIUM
Tillgänglig från:
BGP PHARMA ULC
ATC-kod:
N03AB02
INN (International namn):
PHENYTOIN
Dos:
30MG
Läkemedelsform:
CAPSULE
Sammansättning:
PHENYTOIN SODIUM 30MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
HYDANTOINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0101375001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2023-06-07
Produktens egenskaper
_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
..........................
Läs hela dokumentet
