Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
STIRIPENTOL
BIOCODEX SAS
N03AX17
STIRIPENTOL
500MG
POWDER FOR SUSPENSION
STIRIPENTOL 500MG
ORAL
30/60/90 PCK
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0153530002; AHFS:
APPROVED
2012-12-21
_ _ _ _ _DIACOMIT stiripentol _ _Page 1 of 38 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DIACOMIT™* stiripentol Capsules, 250 mg and 500 mg, Oral Powder for suspension, 250 mg and 500 mg, Oral In-House Standard Antiepileptic [N03AX17] Biocodex SAS 7 Avenue Gallieni 94250 Gentilly France Imported/Distributed by: Biocodex Canada Inc. 320 Harry Walker Parkway North, 14 Newmarket, ON, L3Y 7B4 Date of Initial Authorization: December 19, 2012 Date of Revision: July 14, 2021 Submission Control Number: 248895 *All trademark rights used under license _ _ _ _ _ _ _DIACOMIT stiripentol _ _Page 2 of 38_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 07/2021 RECENT MAJOR LABEL CHANGES............................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.3 Reconstitution ................................................................................................... 7 4.4 Administration...................................................................... Aqra d-dokument sħiħ