OCTAPLEX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Active substance: PROTEIN S
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B.261.008.UK
Czech Republic, Sweden: Ocplex Hungary: Prothrombin Complex Octapharma Italy, Romania: Pronativ This leaflet was last approved in 10/2012. INFORMATION FOR HEALTHCARE PROFESSIONALS General information about how to use Octaplex is provided in section 3. The following information is intended for medical or healthcare professionals only: Instructions for Treatment Please read all the instructions and follow them carefully! During the procedure described below, aseptic technique must be maintained! The product reconstitutes quickly at room temperature. The reconstituted solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration. After reconstitution the solution must be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements. Dose Bleeding and prevention of bleeding during vitamin K antagonist treatment: The dose will depend on the Internal normalised ratio (INR) before treatment and the targeted INR. In the following table approximate doses (ml/kg body weight of the reconstituted product) required for normalisation of INR ( 1.2 within 1 hour) at different initial INR levels are given. Initial INR Approximate dose* (ml Octaplex/kg body weight) 2 2.5 0.9 1.3 2.5 3 1.3 1.6 3 3.5 1.6 1.9 > 3.5 > 1.9
where 59 (ml/kg) is the reciprocal of the estimated recovery. Required dosage for factor II: Required units = body weight (kg) x desired factor II rise (IU/ml) x 50 If the individual recovery is known that value should be used for calculation. Instructions for reconstitution: 1. If necessary, allow the solvent (Water for Injections) and the powder in the closed vials to reach room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers or the caps of the vials. The temperature of the water bath should not exceed 37C. 2. Remove the caps from the powder vial and the water vial and clean the rubber stoppers with an alcohol swab. 3. Remove the protective cover from the short end of the double-ended needle, making sure not to touch the exposed tip of the needle. Then perforate the centre of the rubber stopper of the water vial with the needle held vertically. In order to withdraw the fluid from the water vial completely, the needle must be introduced into the rubber stopper in such a way that it just penetrates the stopper and is visible in the vial. 4. Remove the protective cover from the other, long end of the double-ended needle, making sure not to touch the exposed tip of the needle. Hold the water vial upside-down above the upright powder vial and quickly perforate the centre of the powder vial rubber stopper with the needle. The vacuum inside the powder vial draws in the water. 5. Remove the double-ended needle with the empty water vial from the powder vial , then slowly rotate the powder vial until it is completely dissolved. Octaplex dissolves quickly at room temperature to a colourless to slightly blue solution. If the powder fails to dissolve completely or an aggregate is formed, do not use the preparation. Instructions for infusion: As a precautionary measure, the patients pulse rate should be measured before and during the infusion. If a marked increase in the pulse rate occurs the infusion speed must be reduced or the administration must be interrupted. 1. After the powder has been reconstituted in the manner described above, remove the protective cover from the filter needle and perforate the rubber stopper of the powder vial. 2. Remove the cap of the filter needle and attach a 20 ml syringe. 3. Turn the vial with the attached syringe upside-down and draw up the solution into the syringe. 4. Disinfect the intended injection site with an alcohol swab. 5. After removing the filter, inject the solution intravenously at a slow speed: Initially 1 ml per minute, not faster than 2 - 3 ml per minute. The filter needle is for single use only. Always use a filter needle when drawing up the preparation into a syringe. No blood must flow into the syringe due to the risk of formation of fibrin clots.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Octaplex 500 IU powder and solvent for solution for infusion
Human prothrombin complex Read all of this leaflet carefully before you start using this medicine. 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. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this l e a f l e t , please tell your doctor or pharmacist. In this leaflet: 1. What Octaplex is and what it is used for 2. Before Octaplex is used 3. How to use Octaplex 4. Possible side effects 5. How to store Octaplex 6. Further information
Take special care with Octaplex Take the advice of a doctor who specialises in clotting disorders, when receiving Octaplex. If you have an acquired deficiency of the vitamin K dependent clotting factors (for example caused by treatment with vitamin K antagonist medicines), Octaplex should only be used when rapid correction of the shortage is necessary such as major bleeding or emergency surgery. In other cases, lowering the dose of the vitamin K antagonist medicine and/or administration of vitamin K is usually sufficient. If you receive a vitamin K antagonist medicine (like warfarin) you may have an increased risk of forming blood clots. In this case, treatment with Octaplex may enhance the risk. If you have been born with a shortage of any of the vitamin K dependent factors, specific coagulation factor product should be used when available. If an allergic or anaphylactic- type reaction occurs, your doctor will stop the infusion immediately and give appropriate treatment. There is a risk of thrombosis or disseminated intravascular coagulation (serious illness, with clots forming all over the body) when you receive Octaplex (particularly if you receive it regularly).You should be observed closely for signs or symptoms of intravascular coagulation or thrombosis. This is especially important if you have a history of coronary heart disease, liver disease, if you are going to have an operation and also if Octaplex is given to very small babies No data are available regarding the use of Octaplex in case of bleeding during the birth due to vitamin K deficiency in the new born.
1. WHAT OCTAPLEX IS AND WHAT IT IS USED FOR Octaplex belongs to a group of medicines called clotting factors. It contains the human vitamin K dependent blood coagulation factors II, VII, IX and X. Octaplex is used to treat and prevent bleeding: caused by medicines called vitamin K antagonists (such as warfarin). These medicines block the effect of vitamin K and cause a shortage of the vitamin K dependent clotting factors in your body. Octaplex is used when rapid correction of the shortage is required. in people born with a shortage of the vitamin K dependent clotting factors II and X. It is used when purified specific clotting factor product is not available.
*The single dose should not exceed 3,000 IU (= 120 ml Octaplex). As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR during treatment is mandatory. Bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when specific coagulation factor product is not available: The calculated required dosage for treatment is based on the empirical finding that approximately 1 IU of factor II or X per kg body weight raises the plasma factor II or X activity by 0.02 and 0.017 IU/ml, respectively. Required units = body weight (kg) x desired factor X rise (IU/ml) x 59
2. BEFORE OCTAPLEX IS USED Octaplex must not be used: if you are allergic (hypersensitive) to one of the ingredients of this product (see section 6: Further Information). if you are allergic (hypersensitive) to heparin or if heparin has ever caused a reduction in the level of platelets in your blood.
Viral Safety When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging virus or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who suffer from a type of anaemia (e.g. sickle cell disease or haemolytic anaemia). It is strongly recommended that every time you receive a dose of Octaplex, the name and batch number of the product are recorded in order to maintain a link to the batches used. Appropriate vaccination (hepatitis A and B) is recommended for you if you receive human plasmaderived prothrombin complex products regularly/repeatedly. Using other medicines Octaplex must not be mixed with other medicinal products.
Octaplex stops the effect of vitamin K antagonist medicines (like Warfarin), but no interactions with other medicines are known. Octaplex may affect the results of clotting tests which are sensitive to heparin. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Octaplex should only be used during pregnancy and breast-feeding if clearly needed. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines It is not known how Octaplex affects the ability to drive and use machines. Important information about some of the ingredients of Octaplex Heparin may cause allergic reactions and reduced blood cell counts which may affect the blood clotting system. Patients with a history of allergic reactions caused by heparin should not use heparin-containing medicines. Octaplex contains 75 -125 mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
Allergic reactions Some patients may have allergic type reactions and fever. Immune system problems: Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Rarely, patients treated with Octaplex for replacement therapy may develop neutralising antibodies (inhibitors) against any of the contained clotting factors. If such inhibitors occur, the replacement therapy will not be very effective. General problems Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Increase in body temperature (fever) has not been observed but may rarely occur. Vascular disorders There is a risk of blood clotting following the administration of this medicine. Nervous system disorders Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Headache may rarely occur. Investigations Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) A temporary increase in liver test results (transaminases) has been rarely observed. Others The heparin in the preparation may cause a sudden fall in the number of platelets in the blood. This is an allergic reaction called heparin-induced thrombocytopenia type II. In rare cases in patients not previously hypersensitive to heparin, this fall in the number of platelets can occur 6-14 days after the start of treatment. In patients with a previous heparin hypersensitivity, this alteration may develop within a few hours of starting treatment. The treatment with Octaplex must be stopped immediately in patients showing this allergic reaction. These patients must not receive heparin containing medicinal products in the future. For information on viral safety see section 2. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Do not use Octaplex after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25 C. Do not freeze. Store in the original package in order to protect from light. The powder should be dissolved only directly before injection. The stability of the solution has been demonstrated for up to 8 hours at +2C to +25C. Nevertheless, to prevent contamination, the solution should be used immediately and on one occasion only.
Marketing Authorization Holder and Manufacturer Marketing Authorization Holder: Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom For any further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom Manufacturers: Octapharma Pharmazeutika Produktionsges.m.b.H. Oberlaaer Str. 235 1100 Vienna Austria Octapharma Lingolsheim S.A.S. 72 Rue du Marchal Foch 67380 Lingolsheim France Octapharma Produktionsgesellschaft Deutschland mbH Wolfgang-Marguerre-Allee 1 31832 Springe Germany Octapharma GmbH Subsidiary Dessau Otto-Reuter-Str. 3 06847 Dessau-Rolau Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Portugal, Republic of Slovenia, Slovak Republic, Spain, United Kingdom: Octaplex
6. FURTHER INFORMATION What Octaplex contains, per vial and after reconstitution with 20 ml solvent The active substances are:
Name of ingredient Octaplex Quantity per vial Octaplex Quantity per ml reconstituted solution
Total protein: Active substances Human coagulation factor II Human coagulation factor VII Human coagulation factor IX Human coagulation factor X Further active ingredients Protein C Protein S
260 - 820 mg
13 - 41 mg/ml
280 - 760 IU 180 - 480 IU 500 IU 360 - 600 IU
14 - 38 IU/ml 9 - 24 IU/ml 25 IU/ml 18 - 30 IU/ml
3. HOW TO USE OCTAPLEX Treatment with Octaplex should be started under the supervision of a doctor who is specialised in clotting disorders. First, the powder is dissolved in water Then the solution is given into a vein (the intravenous route). How much Octaplex you receive, and for how long, depends on: how serious your illness is; where the bleeding is and how severe it is, and your general condition. If you got more Octaplex than you should In case of overdose, the risk is higher of developing clotting complications (such as heart attack and clots in your veins or lungs) disseminated intravascular coagulation (a serious illness where clots form all over the body). 4. POSSIBLE SIDE EFFECTS Like all medicines, Octaplex can cause side effects, although not everybody gets them.
260 - 620 IU 240 - 640 IU
13 - 31 IU/ml 12 - 32 IU/ml
The specific activity of the product is 0.6 IU/mg proteins, expressed as factor IX activity. The other ingredients are: Heparin, tri-sodium citrate dihydrate, Water for Injections. What Octaplex looks like and contents of the pack Octaplex is presented as a powder and solvent for solution for infusion. Octaplex is sold in one carton containing - 1 vial with powder for solution for infusion - 1 vial with the solvent, 20 ml Water for Injections - 1 transfer set (1 double-ended needle and 1 filter needle)
5. HOW TO STORE OCTAPLEX Keep out of the reach and sight of children.
Czech Republic, Sweden: Ocplex Hungary: Prothrombin Complex Octapharma Italy, Romania: Pronativ This leaflet was last approved in 10/2012. INFORMATION FOR HEALTHCARE PROFESSIONALS General information about how to use Octaplex is provided in section 3. The following information is intended for medical or healthcare professionals only: Instructions for Treatment Please read all the instructions and follow them carefully! During the procedure described below, aseptic technique must be maintained! The product reconstitutes quickly at room temperature. The reconstituted solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration. After reconstitution the solution must be used immediately. Any unused product or waste material should be disposed of in accordance with local requirements. Dose Bleeding and prevention of bleeding during vitamin K antagonist treatment: The dose will depend on the Internal normalised ratio (INR) before treatment and the targeted INR. In the following table approximate doses (ml/kg body weight of the reconstituted product) required for normalisation of INR ( 1.2 within 1 hour) at different initial INR levels are given. Initial INR Approximate dose* (ml Octaplex/kg body weight) 2 2.5 0.9 1.3 2.5 3 1.3 1.6 3 3.5 1.6 1.9 > 3.5 > 1.9
where 59 (ml/kg) is the reciprocal of the estimated recovery. Required dosage for factor II: Required units = body weight (kg) x desired factor II rise (IU/ml) x 50 If the individual recovery is known that value should be used for calculation. Instructions for reconstitution: 1. If necessary, allow the solvent (Water for Injections) and the powder in the closed vials to reach room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers or the caps of the vials. The temperature of the water bath should not exceed 37C. 2. Remove the caps from the powder vial and the water vial and clean the rubber stoppers with an alcohol swab. 3. Remove the protective cover from the short end of the double-ended needle, making sure not to touch the exposed tip of the needle. Then perforate the centre of the rubber stopper of the water vial with the needle held vertically. In order to withdraw the fluid from the water vial completely, the needle must be introduced into the rubber stopper in such a way that it just penetrates the stopper and is visible in the vial. 4. Remove the protective cover from the other, long end of the double-ended needle, making sure not to touch the exposed tip of the needle. Hold the water vial upside-down above the upright powder vial and quickly perforate the centre of the powder vial rubber stopper with the needle. The vacuum inside the powder vial draws in the water. 5. Remove the double-ended needle with the empty water vial from the powder vial , then slowly rotate the powder vial until it is completely dissolved. Octaplex dissolves quickly at room temperature to a colourless to slightly blue solution. If the powder fails to dissolve completely or an aggregate is formed, do not use the preparation. Instructions for infusion: As a precautionary measure, the patients pulse rate should be measured before and during the infusion. If a marked increase in the pulse rate occurs the infusion speed must be reduced or the administration must be interrupted. 1. After the powder has been reconstituted in the manner described above, remove the protective cover from the filter needle and perforate the rubber stopper of the powder vial. 2. Remove the cap of the filter needle and attach a 20 ml syringe. 3. Turn the vial with the attached syringe upside-down and draw up the solution into the syringe. 4. Disinfect the intended injection site with an alcohol swab. 5. After removing the filter, inject the solution intravenously at a slow speed: Initially 1 ml per minute, not faster than 2 - 3 ml per minute. The filter needle is for single use only. Always use a filter needle when drawing up the preparation into a syringe. No blood must flow into the syringe due to the risk of formation of fibrin clots.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Octaplex 500 IU powder and solvent for solution for infusion
Human prothrombin complex Read all of this leaflet carefully before you start using this medicine. 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. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this l e a f l e t , please tell your doctor or pharmacist. In this leaflet: 1. What Octaplex is and what it is used for 2. Before Octaplex is used 3. How to use Octaplex 4. Possible side effects 5. How to store Octaplex 6. Further information
Take special care with Octaplex Take the advice of a doctor who specialises in clotting disorders, when receiving Octaplex. If you have an acquired deficiency of the vitamin K dependent clotting factors (for example caused by treatment with vitamin K antagonist medicines), Octaplex should only be used when rapid correction of the shortage is necessary such as major bleeding or emergency surgery. In other cases, lowering the dose of the vitamin K antagonist medicine and/or administration of vitamin K is usually sufficient. If you receive a vitamin K antagonist medicine (like warfarin) you may have an increased risk of forming blood clots. In this case, treatment with Octaplex may enhance the risk. If you have been born with a shortage of any of the vitamin K dependent factors, specific coagulation factor product should be used when available. If an allergic or anaphylactic- type reaction occurs, your doctor will stop the infusion immediately and give appropriate treatment. There is a risk of thrombosis or disseminated intravascular coagulation (serious illness, with clots forming all over the body) when you receive Octaplex (particularly if you receive it regularly).You should be observed closely for signs or symptoms of intravascular coagulation or thrombosis. This is especially important if you have a history of coronary heart disease, liver disease, if you are going to have an operation and also if Octaplex is given to very small babies No data are available regarding the use of Octaplex in case of bleeding during the birth due to vitamin K deficiency in the new born.
1. WHAT OCTAPLEX IS AND WHAT IT IS USED FOR Octaplex belongs to a group of medicines called clotting factors. It contains the human vitamin K dependent blood coagulation factors II, VII, IX and X. Octaplex is used to treat and prevent bleeding: caused by medicines called vitamin K antagonists (such as warfarin). These medicines block the effect of vitamin K and cause a shortage of the vitamin K dependent clotting factors in your body. Octaplex is used when rapid correction of the shortage is required. in people born with a shortage of the vitamin K dependent clotting factors II and X. It is used when purified specific clotting factor product is not available.
*The single dose should not exceed 3,000 IU (= 120 ml Octaplex). As these recommendations are empirical and recovery and the duration of effect may vary, monitoring of INR during treatment is mandatory. Bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when specific coagulation factor product is not available: The calculated required dosage for treatment is based on the empirical finding that approximately 1 IU of factor II or X per kg body weight raises the plasma factor II or X activity by 0.02 and 0.017 IU/ml, respectively. Required units = body weight (kg) x desired factor X rise (IU/ml) x 59
2. BEFORE OCTAPLEX IS USED Octaplex must not be used: if you are allergic (hypersensitive) to one of the ingredients of this product (see section 6: Further Information). if you are allergic (hypersensitive) to heparin or if heparin has ever caused a reduction in the level of platelets in your blood.
Viral Safety When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging virus or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus. The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who suffer from a type of anaemia (e.g. sickle cell disease or haemolytic anaemia). It is strongly recommended that every time you receive a dose of Octaplex, the name and batch number of the product are recorded in order to maintain a link to the batches used. Appropriate vaccination (hepatitis A and B) is recommended for you if you receive human plasmaderived prothrombin complex products regularly/repeatedly. Using other medicines Octaplex must not be mixed with other medicinal products.
Octaplex stops the effect of vitamin K antagonist medicines (like Warfarin), but no interactions with other medicines are known. Octaplex may affect the results of clotting tests which are sensitive to heparin. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Octaplex should only be used during pregnancy and breast-feeding if clearly needed. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines It is not known how Octaplex affects the ability to drive and use machines. Important information about some of the ingredients of Octaplex Heparin may cause allergic reactions and reduced blood cell counts which may affect the blood clotting system. Patients with a history of allergic reactions caused by heparin should not use heparin-containing medicines. Octaplex contains 75 -125 mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
Allergic reactions Some patients may have allergic type reactions and fever. Immune system problems: Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Rarely, patients treated with Octaplex for replacement therapy may develop neutralising antibodies (inhibitors) against any of the contained clotting factors. If such inhibitors occur, the replacement therapy will not be very effective. General problems Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Increase in body temperature (fever) has not been observed but may rarely occur. Vascular disorders There is a risk of blood clotting following the administration of this medicine. Nervous system disorders Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) Headache may rarely occur. Investigations Rare (more than 1 of 10,000, but less than 1 of 1,000 patients) A temporary increase in liver test results (transaminases) has been rarely observed. Others The heparin in the preparation may cause a sudden fall in the number of platelets in the blood. This is an allergic reaction called heparin-induced thrombocytopenia type II. In rare cases in patients not previously hypersensitive to heparin, this fall in the number of platelets can occur 6-14 days after the start of treatment. In patients with a previous heparin hypersensitivity, this alteration may develop within a few hours of starting treatment. The treatment with Octaplex must be stopped immediately in patients showing this allergic reaction. These patients must not receive heparin containing medicinal products in the future. For information on viral safety see section 2. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Do not use Octaplex after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25 C. Do not freeze. Store in the original package in order to protect from light. The powder should be dissolved only directly before injection. The stability of the solution has been demonstrated for up to 8 hours at +2C to +25C. Nevertheless, to prevent contamination, the solution should be used immediately and on one occasion only.
Marketing Authorization Holder and Manufacturer Marketing Authorization Holder: Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom For any further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom Manufacturers: Octapharma Pharmazeutika Produktionsges.m.b.H. Oberlaaer Str. 235 1100 Vienna Austria Octapharma Lingolsheim S.A.S. 72 Rue du Marchal Foch 67380 Lingolsheim France Octapharma Produktionsgesellschaft Deutschland mbH Wolfgang-Marguerre-Allee 1 31832 Springe Germany Octapharma GmbH Subsidiary Dessau Otto-Reuter-Str. 3 06847 Dessau-Rolau Germany This medicinal product is authorised in the Member States of the EEA under the following names: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Portugal, Republic of Slovenia, Slovak Republic, Spain, United Kingdom: Octaplex
6. FURTHER INFORMATION What Octaplex contains, per vial and after reconstitution with 20 ml solvent The active substances are:
Name of ingredient Octaplex Quantity per vial Octaplex Quantity per ml reconstituted solution
Total protein: Active substances Human coagulation factor II Human coagulation factor VII Human coagulation factor IX Human coagulation factor X Further active ingredients Protein C Protein S
260 - 820 mg
13 - 41 mg/ml
280 - 760 IU 180 - 480 IU 500 IU 360 - 600 IU
14 - 38 IU/ml 9 - 24 IU/ml 25 IU/ml 18 - 30 IU/ml
3. HOW TO USE OCTAPLEX Treatment with Octaplex should be started under the supervision of a doctor who is specialised in clotting disorders. First, the powder is dissolved in water Then the solution is given into a vein (the intravenous route). How much Octaplex you receive, and for how long, depends on: how serious your illness is; where the bleeding is and how severe it is, and your general condition. If you got more Octaplex than you should In case of overdose, the risk is higher of developing clotting complications (such as heart attack and clots in your veins or lungs) disseminated intravascular coagulation (a serious illness where clots form all over the body). 4. POSSIBLE SIDE EFFECTS Like all medicines, Octaplex can cause side effects, although not everybody gets them.
260 - 620 IU 240 - 640 IU
13 - 31 IU/ml 12 - 32 IU/ml
The specific activity of the product is 0.6 IU/mg proteins, expressed as factor IX activity. The other ingredients are: Heparin, tri-sodium citrate dihydrate, Water for Injections. What Octaplex looks like and contents of the pack Octaplex is presented as a powder and solvent for solution for infusion. Octaplex is sold in one carton containing - 1 vial with powder for solution for infusion - 1 vial with the solvent, 20 ml Water for Injections - 1 transfer set (1 double-ended needle and 1 filter needle)
5. HOW TO STORE OCTAPLEX Keep out of the reach and sight of children.
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.
