VOLUVEN 6 %w/v Solution for Infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

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

Verfügbar ab:

Fresenius Kabi Limited

ATC-Code:

B05AA07

INN (Internationale Bezeichnung):

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

Dosierung:

6 %w/v

Darreichungsform:

Solution for Infusion

Verschreibungstyp:

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

Therapiebereich:

Blood substitutes and plasma protein fractions

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2006-02-03

Gebrauchsinformation

5
6
The following information is intended for healthcare professionals
only:
USE OF HES SHOULD BE RESTRICTED TO THE INITIAL PHASE OF VOLUME
RESUSCITATION WITH A MAXIMUM TIME INTERVAL OF 24 H.
The maximum daily dose is 30 ml/kg for Volulyte.
The lowest possible effective dose should be applied. Treatment should
be
guided by continuous haemodynamic monitoring so that the infusion is
stopped as soon as appropriate haemodynamic goals have been achieved.
The maximum recommended daily dose must not be exceeded.
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 duration of treatment depends on:
• the extent of the low blood volume
• blood pressure
• the dilution of blood and its components (platelets, red blood
cells etc.).
_Use in children_
Data are limited in children, therefore it is recommended not to use
HES
products in this population.
In the absence of of compatibility studies, this medicinal product
must not
be mixed with other medicinal products.
For single use only.
The product should be used immediately after first opening.
Any unused product or waste material should be disposed of in
accordance
with local requirements.
Use only clear, particle-free solutions and undamaged containers.
Remove the overwrap from the Polyolefin (FREE_flex_) bag prior to use.
1
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or
nurse.
– 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, pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
1. What Volulyte is and what it is used for
2. What you need to know before you use Volulyte
3. How to use Volulyte
4. Possible side effects
5. How to store Volulyte
6. Contents of the pac

Fachinformation

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 (Polyolefine/Freeflex Bag)
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%.
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