DIACOMIT CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

STIRIPENTOL

Commercializzato da:

BIOCODEX SAS

Codice ATC:

N03AX17

INN (Nome Internazionale):

STIRIPENTOL

Dosaggio:

250MG

Forma farmaceutica:

CAPSULE

Composizione:

STIRIPENTOL 250MG

Via di somministrazione:

ORAL

Confezione:

60

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0153530001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-12-21

Scheda tecnica

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