VOLPLEX
Active substance: SUCCINYLATED GELATIN
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Patient Information Leaflet
Volplex
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 Volplex and what does it do? 2. Before being given Volplex 3. How much Volplex to use and for how long 4 Possible side effects 5. Storing Volplex 6. Further Information 1. What is Volplex and what does it do? 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 being given Volplex Do not allow Volplex 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 Volplex; 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 Volplex to use and for how long? 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. 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 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 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 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 (4.0% w/v). 500ml and 1000 ml 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 Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK The manufacturer of Volplex is Serumwerk Bernburg AG, Hallesche Landstrasse 105b, Bernburg, 06406, Germany. Leaflet prepared: March 2010 VOLPLEX is a Registered Pharmaceuticals Ltd. Trademark of Beacon
Volplex
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 Volplex and what does it do? 2. Before being given Volplex 3. How much Volplex to use and for how long 4 Possible side effects 5. Storing Volplex 6. Further Information 1. What is Volplex and what does it do? 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 being given Volplex Do not allow Volplex 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 Volplex; 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 Volplex to use and for how long? 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. 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 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 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 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 (4.0% w/v). 500ml and 1000 ml 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 Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK The manufacturer of Volplex is Serumwerk Bernburg AG, Hallesche Landstrasse 105b, Bernburg, 06406, Germany. Leaflet prepared: March 2010 VOLPLEX 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.
