Balgela 4% W/V Solution For Infusion

Balgela 4% Solution for Infusion

1.3 Product Information

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Mockup provided below for patient information leaflet.

Patient Information Leaflet


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 Balgela and what does it do?

2.    Before being given Balgela

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

4.    Possible side effects

5.    Storing Balgela

6.    Further Information

1.    What is Balgela and what does it do?

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

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

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

2.    Before being given Balgela

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

Each container of Balgela 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 Balgela 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 Balgela 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. T his includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at

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

5. Storing Balgela

Balgela 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

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

•    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 Balgela to use and for how long?

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

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

6. Further Information

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

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

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

This leaflet was last revised in 07/2015

For infusion the usual dose rates are: For Adults: 500 - 1500 ml/hour For Children: 150- 1500 ml/hour For Elderly: As Adults

BALGELA is a Registered SWXP002BNA

Bridging Pharma

Bridging Pharma Ltd

Floor 6. Quadrant Mows*.

4 Thomas Mora Squara.

London |1W 1VW