VOLULYTE POLYOLEFINE BAGS 6 Per Cent Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

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

Предлага се от:

Fresenius Kabi Limited

АТС код:

B05AA07

INN (Международно Name):

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

дозиране:

6 Per Cent

Лекарствена форма:

Solution for Infusion

Вид предписание :

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

Терапевтична област:

Blood substitutes and plasma protein fractions

Статус Оторизация:

Authorised

Дата Оторизация:

2008-05-16

Листовка

Sodium chloride
9 g
Electrolytes:
Na
+
154 mmol/l
Cl
–
154 mmol/l
Theoretical osmolarity:
308 mosml/l
Titratable acidity:
⬍ 1.0 mmol NaOH/l
pH:
4.0 – 5.5
OTHER INGREDIENTS:
Sodium hydroxide, Hydrochloric acid, Water for injections
WHAT VOLUVEN 6% LOOKS LIKE AND CONTENTS OF THE PACK
Voluven 6% 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 plasticized
PVC bag
•
or in a glass bottle
•
in a Polyethylene bottle (KabiPac)
Polyolefin bag (FREE_flex_) with overwrap:
1, 5, 10, 20, 30, 35, 40 x 250 ml; 1, 5, 10, 15, 20 x 500 ml
Plasticized PVC bag with overwrap:
1, 5, 25 x 250 ml; 1, 5, 15 x 500 ml
Colourless type II glass bottle with halobutyl rubber closure and
aluminium cap:
1, 10 x 250 ml; 1, 10 x 500 ml
Polyethylene bottle (KabiPac):
1, 10, 20, 30 x 250 ml; 1, 10, 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
Manufacturers:
Fresenius Kabi Deutschland GmbH
Fresenius Kabi Polska Sp. z.o.o.
61346 Bad Homburg v.d.H.
Wytwórnia Plynów Infuzyjnych
Germany
ul. Sienkiewicza 25
99-300 Kutno, Poland
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA
UNDER THE FOLLOWING NAMES:
Austria:
Voluven (HES 130/0,4) 6% – Infusionslösung
Belgium:
Voluven, 6% (60 mg/ml) oplossing voor infusie/solution pour
perfusion/Infusionslösung
Denmark:
Voluven
Finland:
Voluven 60 mg/ml infuusioneste, liuos
Germany:
Voluven Fresenius 6% Infusionslösung
Greece:
Voluven 6% Διάλυµα για έγχυση
Ireland:
Voluven 6% Solution for Infusion
Iceland:
Voluven 6% Innrennslislyf, lausn
Italy:
Voluven Soluzione per infusione
Luxembourg:
Voluven Fresenius 6%
Norway:
Voluven 60 mg/ml infusjonsvæske, oppløsning
Portugal:
Voluven Fresenius 6%
Sweden:
Voluven, 60 mg/ml infusionsvätska, lösning
The Netherlands:
Voluven, 6% (60 mg

Данни за продукта

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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