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

Electrolytes:
Na
+
154 mmol/l
Cl
–
154 mmol/l
Theoretical osmolarity:
308 mosm/l
Titrable acidity:
⬍ 1.0 mmol NaOH/l
pH:
4.0 – 5.5
Other ingredients: Sodium hydroxide, hydrochloric acid, water for
injections.
WHAT VOLUVEN 10 % LOOKS LIKE AND CONTENTS OF THE PACK
Voluven 10 % is a sterile, clear to slightly opalescent solution,
colourless to slightly yellow. It is contained in:
•
flexible bags made either of polyolefin (FREE_flex_) or
•
in a PE container.
Polyolefin bag (FREE_flex_) with overwrap:
1 x 500 ml, 10 x 500 ml, 20 x 500 ml
Polyethylene bottle (KabiPac, made from LDPE): 1 x 500 ml, 10 x 500
ml, 20 x 500 ml
Not all pack sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way, Manor Park,
Runcorn, Cheshire, WA7 1NT, UK
Manufacturer:
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H.
Germany
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA
UNDER THE FOLLOWING NAMES:
Germany:
Voluven 10 % Infusionslösung
Belgium:
Voluven, 10 % (100 mg/ml) oplossing voor infusie
Bulgaria:
Волувен 10 %
Cyprus:
Voluven 10 %, διάλυµα για έγχυση
Czech Republic:
Voluven 10 %
Denmark:
Voluven 100 mg/ml
Estonia:
Voluforte
Greece:
Voluven 10 %, διάλυµα για έγχυση
Finland:
Voluven 100 mg/ml
Hungary:
Voluven 10 % oldatos infúzió
Ireland:
Voluven 10 %
Italy:
Vonten
Lithuania:
Voluforte 10 % infuzinis tirpalas
Latvia:
Voluforte šīdums infūzijām
Netherlands:
Voluven, 10 % (100 mg/ml) oplossing voor infusie
Poland:
Voluven 10 %
Portugal:
Voluven 10 % Fresenius
Sweden:
Voluven 100 mg/ml infusionsvätska, lösning
Slovenia:
Voluven 100 mg/ml raztopina za infundiranje
Slovak Republic:
Voluven 10 %
United Kingdom:
Voluven 10 %
THIS LEAFLET WAS LAST REVISED IN 02/2016.
5
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 maximu

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 occurs (see section 4.8) the
infusion should
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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