Venofundin 6%

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Hetastarch 60 g;  ; Sodium chloride 9 g;  ;  

Saadav alates:

B Braun New Zealand Ltd

INN (Rahvusvaheline Nimetus):

Poly-O-(2-hydroxyethyl)-starch 60 g

Annus:

6 %

Ravimvorm:

Solution for infusion

Koostis:

Active: Hetastarch 60 g   Sodium chloride 9 g     Excipient: Water for injection

Ühikuid pakis:

Bag, plastic, Ecobag 10 x 500 mL, 20 x 500ml, 10 dose units

Klass:

General sale

Retsepti tüüp:

General sale

Valmistatud:

B Braun Medical AG

Toote kokkuvõte:

Package - Contents - Shelf Life: Bag, plastic, Ecobag 10 x 500ml - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. 0 months opened, Not Specified. use immediately - Bag, plastic, Ecobag 20 x 500ml - 20 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. 0 months opened, Not Specified. use immediately

Loa andmise kuupäev:

2005-05-27

Toote omadused

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Data Sheet
VENOFUNDIN 6%
6% hydroxethyl starch (HES) Solution for Infusion
Presentation
Venofundin is a large volume infusion solution containing 6% hydroxyethyl starch (HES) dissolved in
an isotonic and iso-oncotic solution consisting of 0.9% sodium chloride.
The sterile parenteral solution does not contain any preservatives or antioxidants.
It is clear, colorless aqueous and solution.
Each 1000 ml contains
Poly (0-2-hydroxyethyl) starch (HES)
(Molar substitution: 0.42
(Mean molecular weight: 130,000 Da)
60.0g
Sodium chloride
9.0g
Electrolyte concentration:
Sodium
154 mmol/l
Chloride
154 mmol/l
pH:
4.0-6.5
Theoretical osmolarity:
309 m0smol/l
Titration acidity:
<1.0 mmol/l
Uses
Actions
Pharmacotherapeutic group: Blood substitutes and plasma protein fractions, ACT code: B05A A07
Venofundin is a colloidal plasma volume substitute and contains 6% hydroxyethyl starch (HES) in
Venofundin is a colloidal plasma volume substitute and contains 6% hydroxyethyl starch (HES) in
normal saline (sodium chloride 9mg/ml). Its mean molecular weight is 130,000 Dalton and its molar
substitution is 0.42
Venofundin is isooncotic, i.e., the intravascular plasma volume increase is equivalent to the infused
volume.
The duration of the volume effect depends primarily on molar substitution and to a lesser extent on the
mean molecular weight. Intravascular hydrolysis of HES polymers results in the continuous release of
smaller molecules which are also oncotically active before being excreted via the kidneys.
Venofundin may reduce hematocrit and plasma viscosity.
Following isovolemic administration, the volume-expanding effect is maintained for at least 6 hours.
Pharmacokinetic pr