Volulyte 6% Solution for Infusion

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

Sodium Chloride Ph Eur; magnesium chloride hexahydrate PhEur; Potassium Chloride Ph Eur; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.

Tillgänglig från:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International namn):

Sodium Chloride Ph Eur; magnesium chloride hexahydrate PhEur; Potassium Chloride Ph Eur; HYDROXYETHYL STARCH/HETASTARCH; Sodium acetate trihydrate.

Enheter i paketet:

250ml mL; 500ml mL; 250ml mL; 500ml mL; 250ml mL; 500ml mL; 250ml mL; 500ml mL

Tillverkad av:

FRESENIUS KABI DEUTSCHLAND GMBH

Bipacksedel

Not Applicable

Produktens egenskaper

PIK86752100
VOLULYTE 6%
SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1000mL contains:
Active constituents
Poly (O-2-hydroxyethyl) starch
60.00g
- Molar substitution
0.38 – 0.45
- Mean molecular weight (Mw):
130,000Da
(manufactured from waxy maize starch)
Sodium Acetate trihydrate
4.63g
Sodium Chloride
6.02g
Potassium Chloride
0.30g
Magnesium Chloride hexahydrate
0.30g
Electrolytes:
Na
+
137.0 mmol/L
K
+
4.0 mmol/L
Mg
++
1.5 mmol/L
Cl
-
110.0 mmol/L
CH3COO
-
34.0 mmol/L
Theoretical osmolarity:
286.5 mosm/L
Titratable acidity:
< 2.5 mmol NaOH/L
pH:
5.7 – 6.5
Other ingredients: Sodium Hydroxide, hydrochloric acid, water for
injections.
DESCRIPTION
A clear to slightly opalescent solution, colourless to slightly
yellow.
PHARMACODYNAMICS
Volulyte is an artificial colloid for volume replacement whose effect
on intravascular volume expansion
and haemodilution depends on the molar substitution by hydroxyethyl
groups (0.4), the mean
molecular weight (130,000 Da), the concentration (6%) as well as the
dosage and infusion rate.
Hydroxyethyl starch (130/0.4) contained in Volulyte is derived from
waxy maize starch and has a
substitution pattern (C
2
/C
6
ratio) of approximately 9:1.
Infusion of 500ml of a similar product containing HES 130/0.4 (6%) in
0.9% sodium chloride solution
in 30 minutes in volunteers results in a plateau-like non-expansive
volume increase of approximately
100% of the infused volume which lasts for approximately 4 to 6 hours.
Isovolaemic exchange of blood with HES 130/0.4 in 0.9% sodium chloride
solution maintains blood
volume for at least 6 hours.
PIK86752100
Volulyte contains the electrolytes sodium (Na
+
), potassium (K
+
), Magnesium (Mg
++
), Chloride (Cl
-
)
and acetate (CH
3
COO
-
) in an isotonic composition. Acetate is a metabolisable anion which
is oxidised
in different organs and has an alkalising effect.
Volulyte contains a reduced amount of chloride and therefore
counteracts the development of