VOLUVEN 10 Per Cent Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

POLY-(0-2-HYDROXYETHYL)STARCH (130/0.4), SODIUM CHLORIDE

Available from:

Fresenius Kabi Limited

ATC code:

B05AA07

INN (International Name):

POLY-(0-2-HYDROXYETHYL)STARCH (130/0.4), SODIUM CHLORIDE

Dosage:

10 Per Cent

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Blood substitutes and plasma protein fractions

Authorization status:

Authorised

Authorization date:

2010-08-27

Patient Information leaflet

VOLUVEN 10 % SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
0xxxxx1/00 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 only. 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 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 10 % is and what it is used for
2. What you need to know before you use Voluven 10%
3.
How to use Voluven 10 %
4.
Possible side effects
5.
How to store Voluven 10 %
6.
Contents of the pack and other information
1.
WHAT VOLUVEN 10 % IS AND WHAT IT IS USED FOR
Voluven 10 % 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
0xxxxx1_Voluven_10_UK_PB 09.02.2016 13:13 Seite 1
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VOLUVEN 10%
DO NOT USE VOLUVEN 10% 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

Summary of Product characteristics

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
Voluven 10% Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Electrolytes:
Theoretical osmolarity:
308 mosm/l
Titratable acidity:
< 1.0 mmol NaOH/l
pH:
4.0 – 5.5
For the 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
For intravenous use as infusion.
USE OF HES SHOULD BE RESTRICTED TO THE INITIAL PHASE OF VOLUME
RESUSCITATION WITH A MAXIMUM TIME INTERVAL OF 24
H.
The first 10-20 ml should be infused slowly and under careful
monitoring of the patient so that any
anaphylactoid/anaphylactic reaction can be detected as early as
possible. If an anaphylactic_/_anaphylactoid reaction
Poly(O-2-hydroxyethyl)starch (Ph.Eur.)
- Molar substitution: 0.38 – 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
100 g
Sodium chloride
9 g
Na
+
154 mmol/l
Cl
-
154 mmol/l
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