VOLULYTE SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

HYDROXYETHYL STARCH 130/0.4

Dostupno od:

FRESENIUS KABI CANADA LTD

ATC koda:

B05AA07

INN (International ime):

HYDROXYETHYLSTARCH

Doziranje:

6%

Farmaceutski oblik:

SOLUTION

Sastav:

HYDROXYETHYL STARCH 130/0.4 6%

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

30X250ML/20X500ML

Tip recepta:

Prescription

Područje terapije:

REPLACEMENT PREPARATIONS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2015-03-09

Svojstava lijeka

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
........................................................