Voluven 10%

Package Leaflet: Information for the User

Voluven 10%, 10% + 0.9%, Solution for Infusion

Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution

Warning

Do not use in case of sepsis (severe generalized infection), renal dysfunction, or in critically ill patients. Situations in which this product should never be used are listed in section 2.

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Voluven 10% and what is it used for
• 2. Important information before using Voluven 10%
• 3. How to use Voluven 10%
• 4. Possible side effects
• 5. How to store Voluven 10%
• 6. Package contents and other information

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

Voluven 10% is a plasma substitute used to restore blood volume due to its loss, when the use of crystalloid products is 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 generalized infection (sepsis);
• in patients with burns;
• in patients with renal failure or undergoing dialysis;
• in patients with cerebral hemorrhage (intracranial or cerebral hemorrhage);
• in critically ill patients (e.g., in the Intensive Care Unit);
• in patients with too much fluid in the body and have been informed that they have a condition of overhydration;
• in patients with fluid in the lungs (pulmonary edema);
• in dehydrated patients;
• in patients with a significant increase in sodium chloride levels in the blood;
• in patients with severe liver dysfunction;
• in patients with severe heart failure;
• in patients with severe coagulation disorders;
• in patients after organ transplantation.

Warnings and precautions

Before starting treatment with Voluven 10%, tell your doctor if you have:

• liver dysfunction;
• heart and circulation disorders;
• coagulation disorders;
• renal dysfunction.

Due to the risk of an allergic reaction(anaphylactic/anaphylactoid), the doctor will closely monitor the patient to observe early signs of an allergic reaction after administration of this medicine.
Surgical procedures and injuries:
The doctor will consider whether this medicine is suitable for the patient.
The doctor will carefully determine the dose of Voluven 10% to avoid fluid overload. This will be particularly important in patients with lung, heart, or circulation problems.
Nursing staff will also take measures to monitor the patient's fluid balance, electrolyte levels, and renal function. If necessary, additional medications may be administered.
Additionally, the patient will be ensured to receive sufficient fluids.
Voluven 10% is contraindicated in patients with renal dysfunction or renal impairment requiring dialysis.
If renal dysfunction occurs during treatment:
If the doctor observes the first signs of renal dysfunction, the administration of this medicine will be discontinued. Additionally, there may be a need for monitoring of renal function for up to 90 days.
If Voluven 10% is administered repeatedly, the doctor will monitor blood coagulation, bleeding time, and other functions. In case of coagulopathy, the doctor will discontinue the administration of this medicine.
The use of this medicine is not recommended in patients undergoing open-heart surgery, connected to heart-lung machines that support blood pumping during the procedure.

Children

Data on the use of Voluven 10% in children are limited. The use of hydroxyethyl starch (HES) is not recommended in this age group.

Voluven 10% and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
So far, no interactions between Voluven 10% and other medicines are known.

Voluven 10% with food and drink

There are no data on the negative impact 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 and breastfeeding women. Voluven 10% may be administered to pregnant and breastfeeding women after the doctor has assessed the potential benefits and risks to the child. The doctor will decide whether to discontinue breastfeeding.

Driving and using machines

Voluven 10% has no effect on the ability to drive and use machines.

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 administered.
Method of administration
The medicine is administered by intravenous infusion (drip) with a rate and dose size dependent on specific requirements, the disease being treated, and taking into account the maximum dose.
Do not exceed the maximum daily dose.
Dosage
The doctor will decide on the appropriate dose for the patient.

The doctor will use the smallest effective dose and will not administer the infusion of Voluven 10% for more than 24 hours.

Voluven 10%

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. The use of this medicine is not recommended in children.

Use of a higher dose of Voluven 10% than recommended

As with all plasma substitutes, if the patient receives too high a dose of Voluven 10%, it may cause circulatory overload, which can lead to, for example, water retention in the patient's lungs (pulmonary edema).
The doctor will ensure that the patient receives the correct dose of Voluven 10%. However, different patients require different doses of the medicine. In case of an overdose, the doctor may immediately discontinue the administration of the medicine and, if necessary, administer a medicine that removes excess water from the body (diuretic).
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Blood and lymphatic system disorders

Rarely: after administration of hydroxyethyl starch, dose-dependent coagulation disorders may occur.

Immune system disorders

Rarely: hydroxyethyl starch may lead to 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

Often: itching (during long-term use of high doses of the medicine).

Diagnostic tests

Often: during the administration of hydroxyethyl starch, the serum amylase level may increase, which can interfere with the diagnosis of pancreatitis. However, this should not be misinterpreted as pancreatitis.
Other side effects related to blood dilution, such as prolonged bleeding time, resulting from the use of high doses.
Frequency not known:

• renal impairment;
• liver impairment.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Voluven 10%

Store in a place out of 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 month.
The doctor or nurse will check that the solution is clear, free from particles, and the packaging is undamaged, and that the outer bag has been removed from the polyolefin bag ( freeflex) before use.
The solution should be used immediately after opening, and any unused solution or waste should be disposed of. 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. This will help protect the environment.

6. Package contents and other information

What Voluven 10% contains

1000 ml of solution for infusion contains:

Active substances:

poly(O-2-hydroxyethyl) starch (Ph.Eur.)

• degree of substitution: 0.38 - 0.45
• average molecular weight: 130,000 Da (produced from waxy maize starch) 100 g

sodium chloride
9 g
Electrolytes:
Na
154 mmol/l
Cl
154 mmol/l
Theoretical osmolality:
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 what the package contains

The medicine is a sterile, clear to slightly opalescent, colorless to slightly yellowish solution.
Available in:

• flexible polyolefin bags ( freeflex) or
• polyethylene bottles (KabiPac, made of LDPE).

Polyolefin bag ( freeflex) in a protective outer bag:
1 x 500 ml, 10 x 500 ml, 20 x 500 ml.
Polyethylene bottle (KabiPac, made of LDPE):
1 x 500 ml, 10 x 500 ml, 20 x 500 ml.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Deutschland GmbH
D-61169 Friedberg
Germany
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany
Voluven 10% Infusionslösung
Poland
Voluven 10%
Date of last revision of the package leaflet:05.11.2023

Information intended for healthcare professionals only:

The use of hydroxyethyl starch (HES) should be limited to the initial period of fluid resuscitation, with a maximum administration period of

24 hours.

The maximum daily dose of Voluven 10% is 18 ml/kg body weight.
Use the smallest effective dose. Treatment should be carried out with continuous monitoring of hemodynamics, so that the infusion is discontinued as soon as the appropriate hemodynamic parameters are achieved. Do not exceed the maximum recommended daily dose.
Initially, 10 - 20 ml should be administered slowly, with close monitoring of the patient to quickly detect any anaphylactoid/anaphylactic reaction.
If an anaphylactoid/anaphylactic reaction occurs, the infusion should be discontinued immediately and appropriate treatment should be initiated.
The duration of treatment depends on:

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

Children and adolescents
There are limited data on the use of Voluven 10% in children, and the use of HES 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 should be disposed of in accordance with local regulations.
Only use the solution that is clear, free from particles, and has undamaged packaging.
Before use, remove the protective outer bag from the polyolefin bag ( freeflex).