VOLULYTE SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

HYDROXYETHYL STARCH 130/0.4

Commercializzato da:

FRESENIUS KABI CANADA LTD

Codice ATC:

B05AA07

INN (Nome Internazionale):

HYDROXYETHYLSTARCH

Dosaggio:

6%

Forma farmaceutica:

SOLUTION

Composizione:

HYDROXYETHYL STARCH 130/0.4 6%

Via di somministrazione:

INTRAVENOUS

Confezione:

30X250ML/20X500ML

Tipo di ricetta:

Prescription

Area terapeutica:

REPLACEMENT PREPARATIONS

Dettagli prodotto:

Active ingredient group (AIG) number: 0147581001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-03-09

Scheda tecnica

PRODUCT
MONOGRAPH VOLULYTE
®
6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte
injection
Plasma Volume
Expander
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Preparation:
February 17, 2020
Canada
Submission Control No: 223031
Volulyte - Product Monograph (v 4.1)
Page 2 of 24
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
………………………………………..3
SUMMARY PRODUCT INFORMATION
.....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
................................................................................................................
7
DRUG INTERACTIONS
.................................................................................................................
8
DOSAGE AND ADMINISTRATION
.............................................................................................
8
OVERDOSAGE
...............................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
9
STORAGE AND STABILITY
......................................................................................................
11
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
12
WARNINGS
...................................................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................