ISOPLEX 4% W/V SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Isoplex

4% w/v Solution for Infusion

(succinylated gelatin)

Read all of this leaflet carefully

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1. What Isoplex is and what it is used for

2. Before you use Isoplex

3. How to use Isoplex

4. Possible side effects

5. How to Store Isoplex

• 6. Further Information

1. what isoplex is and what it is used for

Isoplex 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). Isoplex is administered directly into a vein via a drip tube (intravenous infusion).

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

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

2. before you use isoplex

Do not use Isoplex solution for infusion

• – if you know that you are allergic (hypersensitive) to succinylated gelatin or any of the other ingredients of Isoplex.

• – if you are allergic to an allergen called “galactose-a-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
• Liver disease

In these cases, Isoplex 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 Isoplex

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

Isoplex 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.

Isoplex contains Sodium and Potassium

Potassium: This medicine contains 78 mg potassium per 500ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

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 isoplex

You will be given Isoplex via a drip tube inserted into a vein. It is unlikely that you will ever have to use Isoplex 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 Isoplex, and how much Isoplex 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 Isoplex 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 Isoplex 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 Isoplex than you should

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

4. possible side effects

Like all medicines Isoplex 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 temperature, e.g. chills, fever, sweating
• Abnormal feelings in your skin, including itching, rash, swelling or any other changes to your skin
• 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: 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 isoplex

Isoplex 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 Isoplex 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