Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
PHENYTOIN SODIUM
BGP PHARMA ULC
N03AB02
PHENYTOIN
30MG
CAPSULE
PHENYTOIN SODIUM 30MG
ORAL
15G/50G
Prescription
HYDANTOINS
Active ingredient group (AIG) number: 0101375001; AHFS:
APPROVED
2023-06-07
_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 .......................... Perskaitykite visą dokumentą