Volulyte 6% Solution for Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

Fresenius Kabi Limited

ATC code:

B05AA

INN (International Name):

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

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

POLY(O-2-HYDROXYETHYL)STARCH 60 g; POTASSIUM CHLORIDE 0.3 g; MAGNESIUM CHLORIDE HEXAHYDRATE 0.3 g; SODIUM ACETATE TRIHYDRATE 4.63 g; SODIUM CHLORIDE 6.02 g

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2008-04-25

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLULYTE 6% SOLUTION FOR INFUSION
Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution

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, 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 or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
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 pack and other information
1.
WHAT VOLULYTE IS AND WHAT IT IS USED FOR
Volulyte 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 USE VOLULYTE
DO NOT USE VOLULYTE 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

hav

Summary of Product characteristics

Page 1 of 11
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:
Poly (O-2-hydroxyethyl)starch (Ph. Eur.)
- Molar substitution: 0.38 – 0.45
- Mean molecular weight: 130,000 Da
(manufactured from waxy maize starch)
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
Electrolytes:
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
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.
Page 2 of 11
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 depends 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 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 approp