VOLUVEN

Patient Information Leaflet

VOLUVEN, (60 mg + 9 mg)/ml, 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 listed in section 2.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse immediately. See section 4.

Table of Contents

1. What VOLUVEN is and what it is used for
2. Important information before using VOLUVEN
3. How to use VOLUVEN
4. Possible side effects
5. How to store VOLUVEN
6. Contents of the pack and other information

1. What VOLUVEN is and what it is used for

VOLUVEN 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

When not to use VOLUVEN:

• if the patient is allergic to any of the active substances or to 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. admitted to Intensive Care Units);
• in patients who have excess fluid in the body and have been diagnosed with fluid overload;
• in patients with presence of fluid in the lungs (pulmonary edema);
• in dehydrated patients;
• in patients with markedly increased blood sodium chloride concentration;
• in patients with severe liver function disorders;
• in patients with severe heart failure;
• in patients with severe blood coagulation disorders;
• in patients after organ transplantation.

Warnings and precautions
Before starting treatment with VOLUVEN, inform the doctor if the patient has:

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

Due to the risk of allergic reactions (anaphylactic/anaphylactoid reactions), 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 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 provided with adequate fluid supply.
VOLUVEN 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 is administered repeatedly, the doctor will monitor blood coagulation, bleeding time, and other parameters. If coagulation disorders occur, the doctor will discontinue administration of this medicine.
Use of this medicine is not recommended in patients undergoing open-heart surgery connected to a heart-lung machine that supports blood circulation during the procedure.

Children
Data on the use of VOLUVEN in children are limited. Use of hydroxyethyl starch (HES)-containing medicines is not recommended in this age group.

VOLUVEN and other medicines
Inform the doctor or nurse 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 and other medicines are currently known.

VOLUVEN with food and drink
There is no information available regarding any negative effects of VOLUVEN when used with food or drink.

Pregnancy, breastfeeding, and fertility
There is insufficient data on the use of VOLUVEN in pregnant or breastfeeding women. Animal studies have not shown any direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition, or postnatal development. No teratogenic effects were observed.
VOLUVEN may be administered to women during pregnancy and breastfeeding if, in the doctor's judgment, the potential benefit to the mother outweighs the potential risk to the fetus or infant.
It is unknown whether hydroxyethyl starch passes into human milk. Passage into milk has not been studied in animals. If the patient is breastfeeding, the decision on whether to continue or discontinue breastfeeding or to continue or discontinue treatment with VOLUVEN solution should be made by the doctor, taking into account both the benefits of breastfeeding for the infant and the benefits of treatment for the patient.

Driving and operating machinery
VOLUVEN has no influence on the ability to drive or operate machinery.

3. How to use VOLUVEN

VOLUVEN is administered by a doctor or under direct medical supervision, with careful monitoring of the volume infused.
Administration method
The medicine is given as an intravenous infusion (drip) at a rate and dose adjusted according to individual requirements, the condition being treated, and taking into account the maximum recommended dose.
The maximum daily dose must not be exceeded.
Dosing
The physician will determine the appropriate dose for the patient.
The physician will use the lowest effective dose and will not administer the VOLUVEN infusion for longer than 24 hours.
The maximum daily dose of VOLUVEN is 30 mL/kg body weight.
Use in children
Experience with this medicine in children is limited. Use of this medicine in children is not recommended.
Administration of a higher than recommended dose of VOLUVEN
As with all plasma substitute solutions, if the patient receives too high a dose of VOLUVEN, this may lead to circulatory overload, which could result, for example, in fluid accumulation in the lungs (pulmonary edema).
The physician will ensure that the patient receives the correct dose of VOLUVEN. However, different patients may require different doses. In case of accidental overdose, the physician 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 questions 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 gets 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
Frequent: itching (during long-term administration of high doses of the medicinal product).

Investigations
Frequent: during administration of hydroxyethyl starch, serum amylase activity 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 unknown (frequency cannot be determined from available data):

• liver function impairment;
• kidney function impairment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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
tel.: +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 adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store VOLUVEN

Keep the medicine out of the sight and reach of children.
Store below 25°C. Do not freeze.
Do not use VOLUVEN 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, free from particles, the packaging is undamaged, and that the outer bag has been removed from the polyolefin bag (free**flex**) before administration.
The solution should be used immediately after opening, and any unused portion must be discarded. For single use only.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What VOLUVEN contains
1000 ml of infusion solution contains:
Active substances:
poly(oxyethylene)starch 60 g

• degree of substitution: 0.38 - 0.45
• average molecular weight: 130,000 Da (derived from corn starch)

sodium chloride 9 g
Electrolytes:
Na 154 mmol/l
Cl 154 mmol/l
Theoretical osmolarity 308 mOsmol/l
Acidity of the solution <1.0 mmol NaOH/l
pH 4.0 – 5.5
Other components are: sodium hydroxide, hydrochloric acid 25%, water for injections.
What VOLUVEN 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 bags of the free flex type: 250 ml, 500 ml;
• polyethylene bottles of the bottlepack type: 250 ml, 500 ml;
• polyethylene containers KabiPac with cap: 1x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany
Manufacturer
Fresenius Kabi Deutschland GmbH
Werk Friedberg
D-61169 Friedberg
Freseniusstrasse 1
Germany
Fresenius Kabi Polska Sp. z o.o.
Infusion Solutions Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno
For further information, contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

The use of drugs containing hydroxyethyl starch (HES) should be restricted to
the initial phase of intravascular volume resuscitation, with a maximum duration of
administration of up to 24 hours.
The maximum daily dose is 30 ml/kg body weight of VOLUVEN.
The lowest effective dose should be used. Treatment should be administered with continuous
hemodynamic monitoring, and 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 observation of the patient to detect as early as possible any anaphylactic/anaphylactoid reaction.
If an anaphylactic/anaphylactoid 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;
• blood dilution and its components (platelets, red blood cells, etc.).

Children and adolescents
Data on use in children are limited; therefore, the use of HES-containing drugs is not recommended in this age group.
For single use only.
Use immediately after opening the bottle, bag, or container.
Any unused solution or waste material should be disposed of in accordance with local regulations.
Only use a clear solution free from particulate matter and from undamaged packaging.
Before use, remove the outer protective polyolefin bag from the free flex bag.