ISOPLEX 4% W/V SOLUTION FOR INFUSION
Active substance: SUCCINYLATED GELATIN
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Patient Information Leaflet
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 further questions, please ask your doctor or nurse. In this leaflet: 1. What is Isoplex and what does it do? 2. Before being given Isoplex 3. How much Isoplex to use and for how long 4 Possible side effects 5. Storing Isoplex 6. Further Information 1. What is Isoplex and what does it do ? 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 infection. 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 being given Isoplex Do not allow Isoplex 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 Isoplex; Heart failure Kidney (renal) failure Liver disease 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 Isoplex to use and for how long? 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. 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
If you suffer from any of these side effects, or any other undesired effect, please inform your doctor or nurse immediately. 5. Storing 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
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 Isoplex is succinylated gelatin (4% w/v). 500ml and 1000 ml bags of Isoplex contain 20g and 40g of succinylated gelatin respectively. The other ingredients are sodium chloride, sodium lactate, potassium chloride, magnesium chloride, sodium hydroxide, hydrochloric acid, and water for injections. Isoplex 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 Isoplex is Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK The manufacturer of Isoplex is Serumwerk Bernburg AG, Hallesche Landstrasse 105b, Bernburg, 06406, Germany. Leaflet prepared: March 2010 ISOPLEX is a Registered Pharmaceuticals Ltd. Trademark of Beacon
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 further questions, please ask your doctor or nurse. In this leaflet: 1. What is Isoplex and what does it do? 2. Before being given Isoplex 3. How much Isoplex to use and for how long 4 Possible side effects 5. Storing Isoplex 6. Further Information 1. What is Isoplex and what does it do ? 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 infection. 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 being given Isoplex Do not allow Isoplex 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 Isoplex; Heart failure Kidney (renal) failure Liver disease 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 Isoplex to use and for how long? 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. 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
If you suffer from any of these side effects, or any other undesired effect, please inform your doctor or nurse immediately. 5. Storing 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
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 Isoplex is succinylated gelatin (4% w/v). 500ml and 1000 ml bags of Isoplex contain 20g and 40g of succinylated gelatin respectively. The other ingredients are sodium chloride, sodium lactate, potassium chloride, magnesium chloride, sodium hydroxide, hydrochloric acid, and water for injections. Isoplex 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 Isoplex is Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK The manufacturer of Isoplex is Serumwerk Bernburg AG, Hallesche Landstrasse 105b, Bernburg, 06406, Germany. Leaflet prepared: March 2010 ISOPLEX is a Registered Pharmaceuticals Ltd. Trademark of Beacon
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
