Voluven 10%

Package leaflet: information for the user

Voluven 10%, 10% + 0,9%, infusion solution
Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution
Warning
Do not use in sepsis (severe systemic infection), renal dysfunction,
or in critically ill patients.
Situations in which this product must never be used are described in section 2.
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Voluven 10% is and what it is used for
2. What you need to know before you are given Voluven 10%
3. How to use Voluven 10%
4. Possible side effects
5. How to store Voluven 10%
6. Contents of the pack and other information

1. What Voluven 10% is and what it is used for

Voluven 10% is a plasma volume expander used to restore blood volume lost due to hemorrhage or trauma, when crystalloid solutions alone are not sufficient.

2. Important information before using Voluven 10%

When not to use Voluven 10%:

• if the patient is allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6);
• in patients with severe systemic infection (sepsis);
• in patients with burns;
• in patients with kidney failure or undergoing dialysis;
• in patients with bleeding in the brain (intracranial or cerebral hemorrhage);
• in critically ill patients (e.g. those admitted to Intensive Care Units);
• in patients who have excess fluid in the body and have been diagnosed with fluid overload;
• in patients with fluid accumulation in the lungs (pulmonary edema);
• in dehydrated patients;
• in patients with markedly elevated sodium chloride blood levels;
• in patients with severe liver function disorders;
• in patients with severe heart failure;
• in patients with severe blood coagulation disorders;
• in patients following organ transplantation.

Warnings and precautions
Before starting treatment with Voluven 10%, inform the doctor if the patient has:

• liver function disorders;
• heart or circulatory disorders;
• blood coagulation disorders;
• kidney function disorders.

Due to the risk of allergic reactions (anaphylactic/anaphylactoid), the doctor will closely monitor the patient for early signs of an allergic reaction after administration of this medicine.
Surgery and trauma:
The doctor will consider whether this medicine is appropriate for the patient.
The doctor will carefully determine the dose of Voluven 10% to avoid fluid overload, particularly in patients with lung, heart, or circulatory problems.
Nursing staff will also take measures to monitor the patient's fluid balance, blood electrolyte levels, and kidney function. Additional medications may be administered if necessary.
Furthermore, the patient will be ensured adequate fluid intake.
Voluven 10% is contraindicated in patients with kidney function disorders or kidney injury requiring dialysis.
If kidney function disorders occur during treatment:
If the doctor observes early signs of kidney dysfunction, administration of this medicine will be discontinued. Additionally, kidney function may need to be monitored for up to 90 days.
If Voluven 10% is administered repeatedly, the doctor will monitor blood coagulation, bleeding time, and other parameters. If coagulation disorders develop, the doctor will discontinue administration of this medicine.
Use of this medicine is not recommended in patients undergoing open-heart surgery who are connected to a heart-lung machine that supports blood circulation during the procedure.
Children
Clinical data on the use of Voluven 10% in children are limited. Use of hydroxyethyl starch-containing (HES) medicines is not recommended in this age group.
Voluven 10% and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
No interactions between Voluven 10% and other medicines are currently known.
Voluven 10% with food and drink
There are no data indicating any negative effects of Voluven 10% when used with food or drink.
Pregnancy and breastfeeding
There are no clinical data on the safety of Voluven 10% in pregnant or breastfeeding women. Voluven 10% may be administered to pregnant women and those who are breastfeeding only after the doctor has evaluated the potential benefits against the potential risks to the child. The doctor will decide whether breastfeeding should be discontinued.
Driving and operating machinery
Voluven 10% has no influence on the ability to drive or operate machinery.

3. How to use Voluven 10%

Voluven 10% is administered by a doctor or under the direct supervision of a doctor who carefully
controls the amount of medicine given.
Method of administration
The medicine is given by intravenous infusion (drip) at a rate and dose depending on the
specific requirements, the condition being treated, and taking into account the maximum dose.
The maximum daily dose must not be exceeded.
Dosing
The doctor will decide the appropriate dose to be given to the patient.
The doctor will use the smallest effective dose and will not administer the Voluven 10% infusion for longer than 24 hours.
The maximum daily dose of Voluven 10% is 18 ml/kg body weight.
Use in children
There is limited experience with the use of this medicine in children. Use of this medicine in children is not recommended.
Administration of a higher than recommended dose of Voluven 10%
As with all plasma-replacement fluids, if the patient receives too high a dose of Voluven 10%, this may lead to circulatory overload, which could result, for example, in fluid accumulation in the patient's lungs (pulmonary oedema).
The doctor will ensure that the patient receives the correct dose of Voluven 10%. However, different patients require different doses of the medicine. If too high a dose is administered, the doctor may immediately stop the infusion and, if necessary, administer a medicine to remove excess fluid from the body (a diuretic).
If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Blood and lymphatic system disorders
Rare: Administration of hydroxyethyl starch may lead to dose-dependent coagulation disorders.

Immune system disorders
Rare: Medicinal products containing hydroxyethyl starch may cause severe allergic reactions (skin redness, mild flu-like symptoms, low and high heart rate, throat swelling and breathing difficulties, non-cardiogenic pulmonary edema).

Skin and subcutaneous tissue disorders
Common: Itching (during long-term administration of high doses of the medicinal product).

Investigations
Common: During administration of hydroxyethyl starch, serum amylase concentration may increase, which may interfere with the diagnosis of pancreatitis. However, this should not be incorrectly interpreted as indicating the presence of pancreatitis.

Other adverse effects related to blood dilution, such as prolonged blood coagulation time, resulting from administration of high doses.

Frequency not known:

• Renal function impairment;
• Hepatic function impairment.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables continuous monitoring of the benefit-risk balance of the medicinal product.

5. How to store Voluven 10%

Keep out of the sight and reach of children.
Do not freeze.
Do not use Voluven 10% after the expiry date stated on the label.
The expiry date refers to the last day of the stated month.
The doctor or nurse will check that the solution is clear and free from particles, that the packaging
is undamaged, and that the outer bag has been removed from the polyolefin bag (freeflex) before
administration.
The solution should be used immediately after opening, and any unused portion should be
discarded. For single use only.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Voluven 10% contains
1000 ml of infusion solution contains:
Active substances:
poly(O-2-hydroxyethyl)starch (Ph.Eur.) 100 g

• degree of substitution: 0.38 - 0.45
• average molecular weight: 130,000 Da (produced from waxy maize starch)

sodium chloride 9 g
Electrolytes:
Na 154 mmol/l
Cl 154 mmol/l
Theoretical osmolarity: 308 mOsm/l
Acidity of the solution: <1.0 mmol NaOH/l
pH: 4.0 - 5.5
Other ingredients are: sodium hydroxide, hydrochloric acid, water for injections.
What Voluven 10% looks like and contents of the pack
The medicine is a sterile, clear to slightly opalescent, colourless to slightly yellow solution.
It is available in:

• polyolefin flexible bags ( free flex ), or
• polyethylene bottles (KabiPac made from LDPE).

Polyolefin flexible bag ( free flex ) in an outer protective bag:
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
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
Fresenius Kabi Deutschland GmbH
D-61169 Friedberg
Germany
For further information, contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area under the following names:
Germany Voluven 10% Infusionslösung
Poland Voluven 10%

Information intended exclusively for healthcare professionals:

The use of hydroxyethyl starch (HES)-containing medicinal products should be restricted to the initial
period of intravascular volume resuscitation, with a maximum duration of administration of up to
24 hours.
The maximum daily dose of Voluven 10% is 18 ml/kg body weight.
The lowest effective dose should be used. Treatment should be administered under continuous
hemodynamic monitoring, and the infusion should be discontinued as soon as the appropriate
hemodynamic parameters have been achieved. The maximum recommended daily dose must not be exceeded.
The initial 10–20 ml should be administered slowly, with close monitoring of the patient to detect as early as possible any anaphylactoid/anaphylactic reaction.
If an anaphylactoid/anaphylactic reaction occurs, the infusion must be stopped immediately and appropriate treatment initiated.
The duration of treatment depends on:

• the volume of blood lost by the patient;
• arterial blood pressure;
• hemodilution and blood components (platelets, red blood cells, etc.).

Children and adolescents
There are limited data on the use of HES in children; the use of HES-containing products is not recommended in this age group.
For single use only.
Use immediately after opening the bottle or bag.
Any unused solution or waste material must be disposed of in accordance with local regulations.
Only a clear, particle-free solution in an undamaged container should be used.
Before use, remove the outer protective polyolefin bag ( free flex ).