VOLUVEN SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

HYDROXYETHYL STARCH 130/0.4

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

B05AA07

DCI (Dénomination commune internationale):

HYDROXYETHYLSTARCH

Dosage:

6%

forme pharmaceutique:

SOLUTION

Composition:

HYDROXYETHYL STARCH 130/0.4 6%

Mode d'administration:

INTRAVENOUS

Unités en paquet:

250ML/500ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

REPLACEMENT PREPARATIONS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-03-10

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
VOLUVEN
®
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection
Plasma Volume Expander
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C84
Date of Revision:
February 17, 2020_ _
Submission Control No: 222938
_Product Monograph: VOLUVEN_
_® _
_(v 3.6) 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
..................................................................................................
6
DRUG INTERACTIONS
..................................................................................................
7
DOSAGE AND ADMINISTRATION
..............................................................................
7
OVERDOSAGE
................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 8
STORAGE AND STABILITY
........................................................................................
10
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
........................................................................
15
CLINICAL TRIALS
.........................................................................