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PATIENT INFORMATION LEAFLET OCTAPLAS® (Human Plasma) Please read this leaflet carefully before using this medicine. This leaflet provides a summary of the information important to the use of OCTAPLAS®. Should you have a question, please talk to your doctor. WHAT IS IN YOUR MEDICINE? The product is named OCTAPLAS and the generic term is Human Plasma. OCTAPLAS is a solution containing human plasma proteins. Human plasma is the fluid part of human blood that carries the cells. OCTAPLAS® also contains an amino-acid (glycine). Trace amounts of an anticoagulant (Sodium citrate dihydrate), a buffer component (sodium dihydrogenphosphate dihydrate) and solvent detergent reagents (TNBP and Triton X100) are also present. OCTAPLAS® contains 9.0 to 14.0 g human plasma proteins. OCTAPLAS® is available in 200 ml blood bags, and is manufactured by OCTAPHARMA Pharmazeutika Produktionsges.m.b.H., Oberlaaer Strasse 235, A1100 Vienna, Austria. The Marketing Authorisation holder is OCTAPHARMA Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom. WHAT IS OCTAPLAS® USED FOR? OCTAPLAS® is used in the same way as normal fresh frozen plasma: OCTAPLAS helps in case of complex deficiencies of coagulation factors which can be caused by massive transfusion, severe failure of the liver. OCTAPLAS may also be given in emergency situations when a coagulation factor concentrate (such as Factor V or Factor XI) is not available or a necessary laboratory diagnosis is not possible. It may also be given when Vitamin K levels are too low due to insufficient liver function. In patients with a disease called Thrombotic Thrombocytopenic Purpura (TTP), in which there is a reduced amount of special blood cells called platelets and for treatment of bleeding within the body as a result of intensive plasma exchange procedures, OCTAPLAS may be used to restore the balance between the coagulation factors.

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WHEN MUST YOU NOT RECEIVE OCTAPLAS® ? You must not receive OCTAPLAS if you are allergic to any preparation of human plasma, especially if you are one of those rare patients who have antibodies against the immunoglobulin called IgA. You must not receive OCTAPLAS if you have a low level of protein S (a vitamin K dependent protein in your blood).

SPECIAL WARNINGS OCTAPLAS should be used with caution if you have a low level of immunoglobulin A; if you had previous reactions to plasma protein including fresh frozen plasma; or if you are suffering from heart failure or fluid in the lungs (pulmonary oedema). You should inform your doctor if you have known risks for blood clotting (thrombotic) complications because of the potential increased risk of venous thromboembolism (clots forming in your veins). OCTAPLAS is not generally recommended for the treatment of von Willebrand’s disease. OCTAPLAS should not be used in case of increased inhibition of coagulation (fibrinolysis) Data on the use of OCTAPLAS in premature babies are very limited, therefore, the product should only be administered to these individuals only if the doctor considers it necessary. REACTIONS WITH OTHER MEDICAMENTS During clinical trials, OCTAPLAS® has been administered in combination with various other medications, and no interactions have been identified. OCTAPLAS® may not be mixed with other intravenous fluids or medicines except red blood cells and blood platelets. To avoid the possibility of blood clots, solutions containing calcium must not be administered by the same intravenous pathway as OCTAPLAS®. There are no known reactions with other drugs. WHAT IF YOU ARE PREGNANT OR BREAST FEEDING? If you are pregnant you must tell your doctor. You will only be given OCTAPLAS® if your doctor considers it important for you. HOW IS OCTAPLAS® GIVEN? Allow the content of the bag to warm to approximately +37°C in a water bath before infusion, but the temperature of Octaplas must not exceed +37°C.

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The thawing procedure should not take longer than 30 minutes. Before OCTAPLAS® can be given to you by infusion an ABO-blood group compatibility test must be performed. In emergency cases, OCTAPLAS® blood group AB can be given to all patients. OCTAPLAS® is given by an infusion into your veins. It is important that the infusion rate should not exceed 1 ml OCTAPLAS® per kg of your body weight per minute. HOW MUCH OCTAPLAS® SHOULD YOU RECEIVE? Your dosage depends upon your clinical situation and your body weight. Your doctor will determine the appropriate amount that you should receive. Special dosage recommendations: The dosage for coagulation factor deficiencies is 5 to 20 ml OCTAPLAS per kg of your body weight. In TTP patients (patients with a reduced amount of platelets) the whole plasma volume exchanged should be replaced with OCTAPLAS. For the treatment of bleeding within the body (haemorrhages) in intensive plasma exchange procedures your doctor will determine the necessary dosage. Calcium gluconate may be given into another vein to minimise the negative effects of the citrate contained in OCTAPLAS. You should be observed for at least 20 minutes after the administration in case you develop am allergic reaction (anaphylactic reaction) or shock, in which case the infusion must be stopped immediately. WHAT SIDE EFFECTS CAN OCCUR? As with all medicines, OCTAPLAS may cause unwanted effects in some patients. These may include: fatigue, tingling feelings (paraesthesia), tremor, flushing, chills (shivering with or without fever), nausea, vomiting, local swelling (oedema), fever, abnormal symptoms in the lungs and low calcium levels. Some patients may have allergic type reactions such as: rash, fever, chills, nausea, vomiting, and abdominal or back pain. Rarely, the infusion of human plasma may cause anaphylactic shock (an immediate serious allergic reaction which produces a flushing of the skin; drop in blood pressure; difficulty in breathing and collapse). High infusion rates may cause circulatory disorders especially in patients with liver function abnormalities. Rarely, incompatibility between antibodies in OCTAPLAS® and antigens in your blood can result in haemolytic transfusion reactions; chills; fever; a non-productive cough; difficulty in breathing; rash; and bleeding within the body. Infusion of OCTAPLAS® may give rise to specific coagulation factor antibodies. High dosages or infusion rates may induce increased blood volume; oedema in the lungs and/or cardiac failure.

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Depending on type and severity of adverse reactions, the infusion rate must be reduced or the administration must be stopped. Appropriate action will be taken by your doctor. If you experience any of these or any other side effects, please inform your doctor.

HOW DO YOU STORE OCTAPLAS®? OCTAPLAS® should be stored in a freezer at  -18°C and protected from light. Always check the expiry date given on the label. OCTAPLAS® has a shelf life of 4 years. Never use any medicine after the expiry date printed on the label. Once the bag has been opened, the product must be used immediately. After thawing Octaplas can be stored for up to 8 hours at +4°C or for up to 4 hours at room temperature (+20 to +25°C) before use. Thawed OCTAPLAS® must not be refrozen. Unused product must be discarded. Do not use solutions which are cloudy or have deposits. MEDICINES PURIFIED FROM HUMAN PLASMA When medicine is purified or made from human plasma or blood, an extremely small chance exists of blood-borne infectious agents being passed on to you. Octapharma only uses carefully screened plasma in the production of OCTAPLAS®. The donors are screened at the donor centre and the plasma tested for viruses after donation. After pooling, the plasma is tested again by Octapharma. Included in the manufacturing process of OCTAPLAS® is a special step, a solvent detergent process, which helps to destroy some additional viruses that may have escaped detection in testing. This step is not completely effective for all viruses. In addition OCTAPLAS® contains protective antibodies for a whole host of viruses. These antibodies have been shown to protect patients against many of the viruses which are unaffected by the solvent detergent process. However, despite all these precautions taken by Octapharma, we cannot completely eliminate the chance that a blood-borne infection may be passed on. Your doctor may suggest vaccination, as appropriate, to help protect against the risk of infection from human blood or plasma. OTHER INFORMATION The information in this leaflet only applies to OCTAPLAS®. If you want more detailed information, you should consult your doctor or nurse. OCTAPLAS® is a registered trademark of Octapharma A.G., Switzerland.

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LAST DATE OF REVISION OF THIS LEAFLET 03. October 2008

Octapharma Limited The Zenith Building 26 Spring Gardens Manchester M2 1AB United Kingdom Tel: 01618373770

Fax: 01618373799