Patient leaflet - Volplex

1. What Volplex is and what it is used for

Volplex is a temporary plasma substitute solution containing succinylated gelatin 4% w/v (Plasma is the fluid component of blood in which the red cells and white cells are carried). Volplex is administered directly into a vein via a drip tube (intravenous infusion).

You will be given Volplex if you have lost blood or body fluids because of bleeding, injury, surgery, burns or infection. It takes time for your body to replace the blood or body fluids that you have lost. Volplex can help maintain the volume of fluid in your blood vessels during that time. Volplex is not intended to provide nutrition nor replace blood components such as red cells which carry oxygen or white cells which fight infection; Volplex can only replace lost fluid volume.

Volplex can be used for the treatment of initial blood loss during pregnancy.

2. Before you use Volplex

Do not use Volplex solution for infusion

if you know that you are allergic (hypersensitive) to succinylated gelatin or any of the other ingredients of Volplex.
if you are allergic to an allergen called “galactose-α-1,3-galactose” (alpha-Gal) or to red meat (mammal meat) and offal.

Warnings and precautions

Before you use this medicine, tell your doctor if you have now or have had in the past

Heart failure
Kidney (renal) failure

In these cases, Volplex should not be given to you due to possible cross-reactions:

if you know you have an allergy to red meat (mammal meat) or offal
if you have been tested positive to antibodies (IgE) against the allergen alpha-Gal

All plasma substitutes carry a slight risk of allergic reactions that are mostly mild or moderate but can in very few cases also become severe. Such reactions are assumed to be more frequent in patients with known allergic conditions such as asthma. For that reason you will be under close observation by a health professional, especially at the

beginning of the infusion.

Other medicines and Volplex

Please tell your doctor or nurse if you are taking, or have recently taken, any other medicine, including those medicines obtained without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or nurse for advice if you are pregnant or breast-feeding.

Driving and using machines

Volplex is normally given to immobile patients in a controlled setting (e.g. emergency treatment, acute treatment in a hospital or a day therapy unit) and this excludes the likelihood of driving and using machines.

Volplex contains Sodium: This medicine contains 1771mg sodium (main component of cooking salt) in each dose (500ml). This is equivalent to 88.5% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or nurse if you need 500ml or more daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

3. How to use Volplex

You will be given Volplex via a drip tube inserted into a vein. It is unlikely that you will ever have to use Volplex yourself; infusion fluids are mainly intended to be given by your doctor or nurse.

Your doctor or nurse will work out how often you should have Volplex, and how much Volplex should be used. The amount given will depend upon your individual needs. You might also be given other infusion fluids or products made from blood, or a blood transfusion.

For infusion the usual dose rates are:

For Adults: 500 – 1500 ml/hour

For Children: 150 – 1500 ml/hour

For Elderly: As Adults

Each container of Volplex is designed to last only a few hours at a time; most of the succinylated gelatin is passed out of the body in less than 12 hours. For this reason, you may be given more Volplex when your doctor or nurse thinks this is necessary. In time, your body will make up the blood or body fluids that you have lost.

If you use more Volplex than you should

An overdose of Volplex may give rise to circulatory overload and electrolyte imbalance.

4. Possible Side Effects

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

Rarely, (between 1 in 1,000 and 1 in 10,000 people), patients may experience an allergic like reaction. Tell your doctor or nurse immediately if you notice any of the following:

Swelling of your face, mouth or throat
Changes in your breathing, e.g. fast breathing, difficulty breathing out, wheezing
Changes in the way your heart beats, e.g. fast beating
Changes in your blood pressure, e.g. feeling dizzy or faint, headache
Changes in your body temperatures e.g. chills, fever, sweating.
Abnormal feelings in your skin, including itching, rash, swelling or any other changes to
your skin

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Shaking of your arms and/or legs

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to Store Volplex

Volplex should not be used if:

the container shows any sign of leakage
the solution is cloudy
the solution is NOT a clear pale yellow or straw colour
particles are visible within the container
the date of use is after the last day of the month of the expiry date, which is stated on the infusion bag in the format MM/YYYY

Previously opened or partly used Volplex should be thrown away. Partially used bags should not be reconnected. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

Please inform your doctor or nurse immediately if you believe that any of the above situations have occurred.

6. Further Information

The active substance in Volplex is succinylated gelatin (4% w/v). 500ml and 1000ml bags of Volplex contain 20g and 40g of succinylated gelatin respectively. The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid, and water for injections.

Volplex is a clear pale yellow or straw coloured solution for infusion which is supplied in 500ml and 1000ml flexible plastic containers (infusion bags).

The Marketing Authorisation Holder for Volplex is Kent Pharma UK Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.

The manufacturer of Volplex is Serumwerk Bernburg AG, Hallesche Landstrasse 105b, Bernburg, 06406, Germany.

This leaflet was last revised in March 2023

VOLPLEX is a Registered Trademark of Beacon Pharmaceuticals Ltd.