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Biostate Consumer Medicine Information (AU)

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Biostate Consumer Medicine Information (AU) 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.
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