XYWAV SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE

Commercializzato da:

JAZZ PHARMACEUTICALS IRELAND LIMITED

Codice ATC:

N07XX04

INN (Nome Internazionale):

HYDROXYBUTYRIC ACID

Dosaggio:

0.234G; 0.096G; 0.13G; 0.04G

Forma farmaceutica:

SOLUTION

Composizione:

CALCIUM OXYBATE 0.234G; MAGNESIUM OXYBATE 0.096G; POTASSIUM OXYBATE 0.13G; SODIUM OXYBATE 0.04G

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Schedule G (CDSA I)

Dettagli prodotto:

Active ingredient group (AIG) number: 0464702001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-05-25

Scheda tecnica

_XYWAV (Calcium, Magnesium, Potassium, and Sodium Oxybates) _
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_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
XYWAV®
Calcium, Magnesium, Potassium, and Sodium Oxybates Solution
Solution, 0.5 g/mL total salts (as calcium, magnesium, potassium and
sodium oxybates), Oral
Must be diluted before use
Central Nervous System Depressant
Jazz Pharmaceuticals Ireland Ltd.
5
th
Floor, Waterloo Exchange
Waterloo Road
Dublin, Ireland D04 E5W7
Importer and Distributor: Innomar Strategies Inc.
3470 Superior Court
Oakville, ON L6L 0C4
Date of Initial Authorization:
May 23, 2023
Submission Control Number: 262870
XYWAV® is a registered trademark of Jazz Pharmaceuticals Inc. or its
affiliates
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_XYWAV (Calcium, Magnesium, Potassium, and Sodium Oxybates) _
_Page 2 of 44 _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
..............................................................................................................
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
..........