Biostate® Human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex, powder for injection.

Consumer Medicine Information

Biostate® 250 IU FVIII/500 IU VWF: AUST R 73032 Biostate® 500 IU FVIII/1000 IU VWF: AUST R 79993 Biostate® 500 IU FVIII/1000 IU VWF: AUST R 150648 Biostate® 1000 IU FVIII/2000 IU VWF: AUST R 150657

What is in this leaflet What Biostate® is difficulty in forming blood clots, with these clots often taking This leaflet answers some used for longer than normal to be made. common questions about Sometimes the individual may Biostate® contains FVIII and Biostate®. It does not contain bleed unexpectedly into their VWF in a purified and complete information about joints, muscles or internal concentrated form. Both FVIII Biostate®. organs. and VWF are blood proteins that are essential for normal blood It does not take the place of Ask your haemophilia clotting. talking to your doctor. treatment centre if you have any questions about why Biostate® is used in patients If you have any concerns Biostate® has been prescribed with von Willebrand disease about using this product, for you. (VWD), a bleeding disorder please talk to your doctor. resulting from low levels of Follow your doctor's advice VWF or abnormal VWF. Before your doctor even if it is different from Individuals with VWD tend to ® what this leaflet says. gives you Biostate take longer than normal to form Tell your doctor if you: Please read this leaflet blood clots, and tend to bleed carefully and keep it for from the skin and mucous  Have allergies to any future reference. membranes such as the nose, mouth and intestines. Because medicines However, the information in this VWF provides stability for the  Are taking or using any leaflet is subject to change. fragile FVIII protein in the other medicines. These Please check with your blood, patients with VWD may include medicines bought haemophilia treatment centre if also have low FVIII levels. from pharmacies, there is any new information supermarkets and health Biostate® is also used in patients about this medicine that you food stores should know since you were last with haemophilia A, a bleeding  Have any other medical treated with this medicine. disorder, in which there are low levels of FVIII or abnormal conditions FVIII. Individuals with low levels or abnormal FVIII have

Biostate AU CMI 19.00 (registered) Page 1 of 6  Are pregnant or breast inactivation/removal of the 1. Ensure you have all the feeding non-enveloped virus, B19. required equipment to Despite these safety measures, administer Biostate®.  Become pregnant during such products may still ® your treatment. 2. Allow the vials of Biostate potentially transmit disease. and Water for Injections to If you want further information, reach room temperature Vaccines are available against consult your doctor or prior to use, which may some of these viruses and your haemophilia treatment centre. take up to one hour. Do not doctor will be able to help you warm the Water for ® decide whether it is worthwhile Biostate is manufactured from Injections in hot water. having any of those vaccines. human plasma (the liquid 3. Remove jewellery, watches, component of blood) collected Please discuss the risks and rings, etc by the Australian Red Cross benefits of Biostate® with your Blood Service. When products 4. Wash hands with soap and doctor. are made from human blood and water, dry with a clean injected into you, it is possible ® towel. that viruses or other substances How to use Biostate 5. Select an appropriate work could be present in the product The dosage and administration area with good lighting and and cause an illness. These ® of Biostate must be carefully a surface which can be could be viruses such as controlled. Your doctor will be cleaned (such as a kitchen hepatitis, HIV (human responsible for determining table). immunodeficiency virus), or what dose is appropriate to your 6. Using a clean cloth or paper parvovirus B19 and theoretically condition. the Creutzfeldt-Jakob disease towel, clean the preparation (CJD) agent. There could also Biostate® will usually be given area with methylated spirits. be other infectious agents some in a hospital. Should your doctor 7. Gather the equipment to be of which may not yet have been decide that treatment at home is used. discovered. appropriate, your haemophilia treatment centre will provide Equipment To reduce the risk of this ® detailed instructions on how to  One carton of Biostate happening, strict controls are ® use Biostate . containing: applied when selecting blood - one vial of Biostate® donors and donations. In The following procedures are addition, extra steps are taken given as a guide only: - one vial of Water for when manufacturing this Injections product. Biostate® is specially ® Preparing Biostate - one Mix2Vial™ filter treated to remove and kill transfer set. Check the viruses. This special treatment is for administration expiry date of each item. considered effective against You will need one 5 mL Water Do not use if expired. certain viruses known as for Injections vial for each enveloped viruses (such as HIV 250 IU and 500 IU (100 IU/mL)  Two alcohol wipes and hepatitis B and C), and also ® vial of Biostate , or one 10 mL  Sharps container the non-enveloped virus, Water for Injections vial for hepatitis A. They are also each 500 IU (50 IU/mL) and known to contribute to the 1000 IU vial of Biostate®.

Biostate AU CMI 19.00 (registered) Page 2 of 6  Waste container for 5. Open the lid of the discarding biological Mix2Vial™ packaging. If material the seal of the lid is not intact or you have any  Plastic syringe(s) other concerns about the  Adhesive tape integrity of the Mix2Vial™, do not use it  Cotton balls but return it to your  Intravenous injection set haemophilia treatment centre or Australian Red  Gloves. Cross Blood Service. Place Instructions for the Water for Injections vial on a level surface and hold ® Biostate the vial firmly. Take the Figure 2 reconstitution Mix2Vial™ together with the outer package, invert it Follow these steps to prepare the and push the blue plastic injection. cannula of the Mix2Vial™ firmly through the rubber 1. Wash hands with soap and stopper of the Water for water, dry with a clean Injections vial. See towel. Figure 1. (5 mL Water for 2. Ensure Biostate® and Water Injections vial is provided for Injections are at room for 250 IU vial and 500 IU temperature. (100 IU/mL) vial and 10 mL Water for Injections 3. Remove flip top caps from vial is provided for 500 IU Biostate® and Water for (50 IU/mL) vial and Injections vials. 1000 IU vial). Figure 3 4. Wipe the rubber stoppers of both the Biostate® and Water for Injections vials with the alcohol wipes and allow to dry for two minutes. Do not leave the alcohol wipes resting on the stoppers. Do not touch the rubber stoppers with your fingers.

Figure 1

Biostate AU CMI 19.00 (registered) Page 3 of 6 seal may be faulty. Do not 10. While the Biostate® vial is use the product but return upright, attach a plastic it to your haemophilia disposable syringe to the treatment centre or the transparent part of the Australian Red Cross Mix2Vial™. Invert the Blood Service. system and draw the Biostate® into the syringe Note: The Mix2Vial™ is by pulling the plunger back intended to filter the slowly. contents of a single vial of Biostate® only. If multiple 11. Once the Biostate® has been vials of Biostate® are to be transferred into the syringe, given, a separate firmly hold the barrel of the Figure 4 Mix2Vial™ must be used syringe (keeping the syringe for each vial. plunger facing down) and ™ WFI = Water for Injections detach the Mix2Vial from 8. With the Water for the syringe. Do not use the ® 6. While holding onto the vial Injections and Biostate Mix2Vial™ for injection. of Water for Injections, vials still attached to the Note: One large syringe carefully remove the outer Mix2Vial™, gently swirl (do may be used to withdraw package from the not shake) the Biostate® Biostate® from multiple Mix2Vial™, being careful to vial until all of the product vials. leave the Mix2Vial™ firmly is dissolved. Ensure the attached to the vial of Water contents of the vial are 12. Discard the empty vial of for Injections. Make sure completely dissolved. If a ® Biostate with the that you only remove the clot or gel forms do not use transparent part of the outer package and not the the product but return it to Mix2Vial™ attached, into an Mix2Vial™. See Figure 2. your haemophilia treatment appropriate waste container. centre or Australian Red 7. With the Biostate® vial held Cross Blood Service. ® firmly on a level surface, Use Biostate as soon as you invert the Water for 9. Once the contents of the can after preparation. (Make Injections with the Biostate® vial are sure it is used for one person Mix2Vial™ attached and completely dissolved, on one occasion only). The push the transparent plastic firmly hold both the solution must not be stored cannula end of the transparent and blue parts and the infusion should be Mix2Vial™ firmly through of the Mix2Vial™. Unscrew completed as soon as the stopper of the Biostate® the Mix2Vial™ into two practicable. Any unused vial. See Figure 3. The separate pieces. See portion remaining in the vial water will be drawn into the Figure 4. Discard the must be discarded vial by the vacuum empty Water for Injections appropriately. contained within the vial with the blue part of the ® ™ Do not refrigerate Biostate Biostate® vial. If water is Mix2Vial still attached once it has been prepared. not drawn into the vial, it into an appropriate waste means that there is no container. vacuum in the vial and the

Biostate AU CMI 19.00 (registered) Page 4 of 6 Injection 12. Carefully remove the  reddening of the face or intravenous needle with neck administration syringe attached and place  chest pain procedure guidelines directly into the sharps container.  sweating The injection is best given by following each of the steps 13. Apply pressure to the  feeling sick or vomiting injection site using a cotton outlined in turn.  strange taste in the mouth ball for one to two minutes. Should any of the symptoms Apply dressing if necessary.  irritation of the vein used listed under "Side Effects" for infusion (which may 14. Discard all used sharps into develop, stop the infusion include swelling, redness or the sharps container, and immediately and contact your tenderness) dispose of the other used haemophilia treatment centre. equipment appropriately.  shortness of breath or difficulty breathing. 1. Apply tourniquet. Select 15. Wash hands with soap and injection site. water, dry with a clean Also, contact your doctor towel. 2. Wash hands with soap and immediately if you experience water, dry with a clean any of these symptoms at any towel. Side effects time: fever, loss of appetite, extreme tiredness, abdominal 3. Cleanse the skin area with Along with their intended pain, jaundice (yellow skin and an alcohol wipe, allow to effects, medicines may cause eyes), dark urine, joint pains and dry. some unwanted effects, which skin rashes. can sometimes be serious. 4. Put on gloves. Furthermore, individual patients 5. Insert intravenous needle may react differently to the Overdose into vein. same dose of the same medicine. No symptoms of overdose with ® 6. Secure needle with adhesive This applies to Biostate , FVIII and/or VWF concentrates tape. although severe reactions after are known. If you have any ® Biostate injection are rare. Ask questions, consult your doctor. 7. Attach the syringe your haemophilia treatment ® containing Biostate to the centre if you need more intravenous needle. How to store information. ® 8. Gently pull back the Biostate Stop using this product plunger until the tubing is Store at 2°C to 8°C (Refrigerate. immediately and contact your filled with blood. Do not freeze). Biostate® can be doctor if any of the following stored below 25°C for a single 9. Release the tourniquet. side effects occur: period of 6 months. The product 10. Administer the Biostate® must not be returned to solution slowly (usually  headache refrigeration after storage below within 5 minutes, or as  pain (such as back pain, 25°C. Protect from light. tolerated). joint pains and bone pains) Do not use after the expiry date. 11. Carefully remove adhesive  dizziness tape.  anxiety

Biostate AU CMI 19.00 (registered) Page 5 of 6 Further information 4. 1000 IU vial of Biostate®, ™ Mix2Vial is a trademark of (with a FVIII concentration West Pharmaceutical Services, This is not all the information of 100 IU/mL and a VWF Inc. or a subsidiary thereof ® that is available on Biostate . If concentration of you have any more questions or 200 IU/mL) 10 mL vial of are not sure about anything, ask Water for Injections, and a your haemophilia treatment special filter transfer set centre. called a Mix2Vial™.

Product description Ingredients What it looks like Biostate® contains FVIII and VWF as the active ingredients. ® Biostate is a white or pale It also contains: yellow powder contained in a glass vial. Biostate® is registered  sucrose in four presentations. Each pack  sodium citrate size contains:  sodium chloride 1. 250 IU vial of Biostate®  trometamol (with a FVIII concentration of 50 IU/mL and a VWF  calcium chloride concentration of  sodium octanoate 100 IU/mL), 5 mL vial of Water for Injections, and a  human albumin special filter transfer set  human plasma proteins. called a Mix2Vial™ 2. 500 IU vial of Biostate® Manufacturer (with a FVIII concentration of 50 IU/mL and a VWF CSL Limited concentration of ABN 99 051 588 348 100 IU/mL), 10 mL vial of 189–209 Camp Road Water for Injections, and a Broadmeadows VIC 3047 special filter transfer set Australia called a Mix2Vial™ Distributed by 3. 500 IU vial of Biostate®, (with a FVIII concentration Australian Red Cross Blood of 100 IU/mL and a VWF Service concentration of 200 IU/mL) 5 mL vial of This leaflet was prepared in Water for Injections, and a November 2013 special filter transfer set ® Biostate is a registered called a Mix2Vial™ trademark of CSL Limited

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