Volulite 6%

Leaflet attached to the packaging: patient information

Volulyte 6%, solution for infusion

Hydroxyethyl starch (HES 130/0.4) in an isotonic electrolyte solution

Warning

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

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

• 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 to you by a doctor and should not be given to anyone else. 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 leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Volulyte 6% and what is it used for

Volulyte 6% is a plasma substitute used to restore blood volume after its loss, when the use of other products, so-called crystalloids, is considered insufficient.

2. Important information before using Volulyte 6%

When not to use Volulyte 6%:

• 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 kidney failure or undergoing dialysis;
• in patients with bleeding in the brain (intracranial or cerebral hemorrhage);
• in critically ill patients (e.g., those in the Intensive Care Unit);
• in patients with too much fluid in the body and have been informed that they have a condition of fluid overload;
• in patients with fluid in the lungs (pulmonary edema);
• in dehydrated patients;
• in patients with a significant increase in potassium or sodium chloride levels in the blood;
• 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 Volulyte 6%, tell your doctor if you have:

• liver function disorders;
• heart and circulation disorders;
• blood coagulation disorders;
• kidney function disorders;
• increased levels of potassium, sodium, magnesium, chloride, or bases in the blood (hyperkalemia, hypernatremia, hypermagnesemia, hyperchloremia).

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 Volulyte 6% to avoid fluid overload. This will be done mainly in patients with lung, heart, or circulatory diseases.
Nursing staff will also take measures to monitor fluid balance, electrolyte levels in the blood, and kidney function. If necessary, additional medicines may be given.
Additionally, the patient will be ensured to receive sufficient fluids.
Volulyte 6% is contraindicated in patients with kidney function disorders or kidney damage requiring dialysis.
If kidney function disorders occur during treatment:
If the doctor observes the first symptoms of kidney function disorders, the administration of this medicine will be stopped. Additionally, there may be a need to monitor kidney function for up to 90 days.
If Volulyte 6% is administered repeatedly, the doctor will monitor blood coagulation, bleeding time, and other functions. In case of loss of blood coagulation, 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 Volulyte 6% in children are limited. It is not recommended to use medicines containing hydroxyethyl starch (HES) in this age group.

Volulyte 6% 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 take.
So far, no interactions between Volulyte 6% and other medicines are known.

Volulyte 6% with food and drink

There is no data on the negative impact of Volulyte 6% when used with food or drink.

Pregnancy and breastfeeding

There is no clinical data on the safety of using Volulyte 6% in pregnant and breastfeeding women.
Volulyte 6% may be administered to pregnant and breastfeeding women after the doctor has assessed the potential benefits and risks to the child.

Driving and using machines

Volulyte 6% has no effect on the ability to drive and use machines.

3. How to use Volulyte 6%

Volulyte 6% 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 depending on specific requirements, the disease being treated, and taking into account 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 Volulyte 6% for longer than 24 hours.

The maximum daily dose of Volulyte 6% is 30 ml/kg body weight.

The initial 10-20 ml should be administered slowly, with close monitoring of the patient to quickly detect any anaphylactic/anaphylactoid reaction.

Use in children

There is limited experience with the use of this medicine in children. It is not recommended to use this medicine in children.

Use of a higher than recommended dose of Volulyte 6%

The doctor will ensure that the patient receives the correct dose of Volulyte 6%. However, different patients require different doses of the medicine. In case of administration of too high a dose, the doctor may immediately stop the administration of the medicine and, if necessary, administer a medicine that removes excess fluid from the body (diuretic).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):

• itching, which is a known side effect of hydroxyethyl starch when administered in higher doses and for a longer period;
• other side effects related to blood dilution, such as prolonged blood coagulation time, resulting from the use of high doses;
• during the administration of hydroxyethyl starch, the amylase activity in the serum may increase, which may interfere with the diagnosis of pancreatitis. However, this should not be misinterpreted as the occurrence of pancreatitis.

Rare(may affect up to 1 in 1,000 people):

• medicines containing hydroxyethyl starch may lead to severe allergic reactions (skin redness, throat swelling, and breathing difficulties, mild flu-like symptoms, low or high heart rate, fluid in the lungs of non-cardiac origin);
• after administration of hydroxyethyl starch, dose-dependent blood coagulation disorders may occur.

Frequency not known(cannot be estimated from the available data):

• kidney damage;
• liver damage.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
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 Volulyte 6%

• Store in a place out of sight and reach of children.
• There are no special precautions for storing the medicine.
• Do not freeze.

Do not use Volulyte 6% 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 if the solution is clear, free from particles, and the packaging is undamaged, and if 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 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. This will help protect the environment.

6. Contents of the packaging and other information

What Volulyte 6% contains

1000 ml of the solution for infusion contains:

Active substances:

hydroxyethyl starch (Ph.Eur.)

• degree of substitution: 0.38 - 0.45
• average molecular weight: 130,000 Da (produced from corn 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
CH3COO
34.0 mmol/l
Theoretical osmolality:
286.5 mOsm/l
Titrateable acidity:
<2.5 mmol NaOH/l
pH:
5.7 – 6.5
Other ingredients are:sodium hydroxide, hydrochloric acid, water for injections.

What Volulyte 6% looks like and what the packaging contains

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

• flexible polyolefin bags of the freeflextype,
• polyethylene containers (KabiPac).

Each packaging is available in 250 ml and 500 ml sizes.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H., Germany

Manufacturer

Fresenius Kabi Deutschland GmbH
61169 Friedberg, Germany
Fresenius Kabi France
6, rue du Rempart
BP 611, 27400 Louviers Cedex, France
Fresenius Kabi Polska Sp. z.o.o.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
To obtain more detailed information, contact the representative of 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 for use in the Member States of the European Economic Area under the following names:

Germany
Volulyte 6% Infusionslösung
Poland
Volulyte 6%
Romania
Volulyte 6%, solutie perfuzabila
Date of last revision of the leaflet:05.11.2023

Information intended exclusively for healthcare professionals:

The use of hydroxyethyl starch (HES) products should be limited to the initial period of fluid resuscitation, with a maximum administration period of 24 hours.

The maximum daily dose of Volulyte 6% is 30 ml/kg body weight.
Use the smallest effective dose. Treatment should be carried out with continuous monitoring of hemodynamics, so that the infusion is stopped as soon as the appropriate hemodynamic parameters are achieved. Do not exceed the maximum recommended daily dose.
The initial 10-20 ml should be administered slowly, with close monitoring of the patient to quickly detect any anaphylactic/anaphylactoid reaction.
The duration of treatment depends on:

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

Children and adolescents
There is limited data on the use of Volulyte 6% in children, and it is not recommended to use HES products in this age group.
Due to the lack of compatibility studies, this medicine must not be mixed with other medicines.
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).