DIACOMIT POWDER FOR SUSPENSION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

STIRIPENTOL

Beschikbaar vanaf:

BIOCODEX SAS

ATC-code:

N03AX17

INN (Algemene Internationale Benaming):

STIRIPENTOL

Dosering:

500MG

farmaceutische vorm:

POWDER FOR SUSPENSION

Samenstelling:

STIRIPENTOL 500MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/60/90 PCK

Prescription-type:

Prescription

Therapeutisch gebied:

MISCELLANEOUS ANTICONVULSANTS

Product samenvatting:

Active ingredient group (AIG) number: 0153530002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2012-12-21

Productkenmerken

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