Patient Information Leaflet

Saljelly

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 further questions, please ask your doctor or nurse.

In this leaflet:

1.    What is Saljelly and what does it do?

2.    Before being given Saljelly

3.    How much Saljelly to use and for how long?

4.    Possible side effects

5.    Storing Saljelly

6.    Further Information

1.    What is Saljelly and what does it do?

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

You will be given Saljelly 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. Saljelly can help maintain the volume of fluid in your blood vessels during that time. Saljelly is not intended to provide nutrition nor replace blood components such as red cells which carry oxygen or white cells which fight infection; Saljelly can only replace lost fluid volume.

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

2.    Before being given Saljelly

Do not allow Saljelly to be given to you if you know that you are allergic (hypersensitive) to succinylated gelatin.

If you are suffering or have suffered from the following conditions, please tell your doctor or nurse before being given Saljelly;

•    Heart failure

•    Kidney (renal) failure

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

Please ask your doctor or nurse for advice if you are pregnant or breastfeeding.

3.    How much Saljelly to use and for how long?

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

4. Possible Side Effects

Like all medicines Saljelly 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 ifyou notice any ofthe 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 ofyour arms and/or legs.

If you get any side effects.talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow CardScheme at www.mhra.gov.uk/yellowcard.

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

5.    Storing Saljelly

Saljelly 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

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

6.    Further Information

The active substance in Saljelly is succinylated gelatin (4.0% w/v). 500ml and 1000ml bags of Saljelly contain 20g and 40g of succinylated gelatin respectively. The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid, and water for injections.

Saljelly 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 Saljelly is Bridging Pharmaceuticals Ltd., Floor 6, Thomas More Square, E1W 1YW, UK.

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

This leaflet was last revised in 07/2015

SAUELLY is a Registere .    |    . Bridging Pharma Ltd

Floor 6. Quadrant Hovir 4 Thomai Mora Square. Bridging Pharma    London 11W 1YW

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