VOLULYTE GLASS BOTTLE 6 Per Cent Solution for Infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM ACETATE TRIHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE

Commercializzato da:

Fresenius Kabi Limited

Codice ATC:

B05AA07

INN (Nome Internazionale):

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM ACETATE TRIHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE

Dosaggio:

6 Per Cent

Forma farmaceutica:

Solution for Infusion

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Blood substitutes and plasma protein fractions

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2008-05-16

Foglio illustrativo

VOLUVEN
®
6% SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
068 3511/03 UK
 This medicine is subject to additional monitoring. This will allow
quick
identification of new safety information. You can help by reporting
any
side effects you may get. See the end of section 4 for how to report
side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Voluven
®
6% is and what it is used for
2.
What you need to know before you use Voluven 6%
3.
How to use Voluven 6%
4.
Possible side effects
5.
How to store Voluven
®
6%
6.
Contents of the pack and other information.
1. WHAT VOLUVEN 6% IS AND WHAT IT IS USED FOR
Voluven 6% is a plasma volume substitute that is used to restore the
blood volume when you have lost blood when other products called
crystalloids are not considered sufficient alone.
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
0683511_03_Voluven UK_PB 08.08.2017 08:29 Seite 1
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLUVEN 6%
DO NOT USE VOLUVEN 6% IF YOU:
•
are allergic to any of the active substances or any of the other
ingredients of this medicine
•
suffer from serious generalised infection (sepsis)
•
suffer from burn injury
•
have kidney impairment or receive dialysis
•
suffer from bleeding in the brain (intracranial or cerebral bleeding)
•
are critically ill (e.g. you need to stay in an intensive care unit)
•
have too much fluid in your body and you have been told that you
have a condition known as hyperhydration
•
hav

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Volulyte 6% Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Electrolytes:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion
A clear to slightly opalescent solution, colourless to slightly
yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypovolaemia due to acute blood loss when crystalloids
alone are not considered sufficient (see sections
4.2, 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Poly(O-2-hydroxyethyl)starch (Ph.Eur.)
- Molar substitution 0.38 – 0.45
- Mean molecular weight = 130,000 Da
(manufactred from waxy maize stach)
60.00 g
Sodium acetate trihydrate
4.63 g
Sodium chloride
6.02 g
Potassium chloride
0.30 g
Magnesium chloride hexahydrate
0.30 g
Na
+
137.0 mmol/l
K
+
4.0 mmol/l
Mg
++
1.5 mmol/l
Cl
-
110.0 mmol/l
CH
3
COO
-
34.0 mmol/l
Theoretical osmolarity:
286.5 mosm/l
Titrable acidity:
< 2.5 mmol NaOH/l
pH:
5.7 – 6.5
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