VOLUVEN 6 %w/v Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE

Available from:

Fresenius Kabi Limited

ATC code:

B05AA07

INN (International Name):

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE

Dosage:

6 %w/v

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:

2000-07-07

Patient Information leaflet

V006 • 4264-7
WHAT IS IN THIS LEAFLET:
1. What Voluven 6% is and what it is used for
2. What you need to know before you take Voluven 6%
3. How to take 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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
• have fluid in the lungs (pulmonary oedema)
• are dehydrated
• have been told that you have a severe increase of sodium or
chloride in your blood
• have severely impaired liver function
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLUVEN6%
SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
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 of the side effects, talk to your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
Austria Voluven (HES 130/0,4) 6 % - Infusionslösung
Belgium Voluven, 6% (60 mg/ml) oplossing vo

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 6% Solution for Infusion (Glass bottle)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Poly(O-2-hydroxyethyl)starch (Ph.Eur.)
60.0 g
- Molar substitution_:_ 0.38 - 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
Sodium chloride
9.00 g
Na
+
154 mmol
Cl
-
154 mmol
Theoretical osmolarity
308 mosmol/l
pH
4.0 - 5.5
Titratable acidity
< 1 mmol NaOH/l
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
anaphylactic/anaphylactoid reaction can be detected as early as
possible.
The daily dose and rate of
infusion depend on the patient’s
blood loss,
on the maintenance or
restoration of
haemodynamics and on the haemodilution (dilution effect).
The maximum daily dose is 30 ml/kg for Voluven 6%.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___