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Biostate® Human Coagulation Factor VIII (FVIII) and Human Von Willebrand Factor (VWF) Complex, Powder for Injection

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Biostate® Human Coagulation Factor VIII (FVIII) and Human Von Willebrand Factor (VWF) Complex, Powder for Injection Biostate® Human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF) complex, powder for injection. Consumer Medicine Information What is in this leaflet are essential for normal blood Before you are given clotting. ® This leaflet answers some Biostate ® common questions about Biostate is used in patients Tell your doctor if you: Biostate®. It does not contain with von Willebrand Disease (VWD), a bleeding disorder complete information about have allergies to any ® resulting from low levels of Biostate . medicines VWF or abnormal VWF. It does not take the place of Individuals with VWD tend to are taking or using any talking to your doctor. take longer than normal to form other medicines. These blood clots, and tend to bleed include medicines bought If you have any concerns from the skin and mucous from pharmacies, about using this medicine, membranes such as the nose, supermarkets and health please talk to your doctor. mouth and intestines. Because food stores. Follow your doctor’s advice VWF provides stability for the have any other medical even if it is different from fragile FVIII protein in the conditions what this leaflet says. blood, patients with VWD may also have low FVIII levels. are pregnant or Please read this leaflet breast-feeding carefully and keep it for Biostate® is also used in patients become pregnant during future reference. with haemophilia A, a bleeding your treatment. disorder, in which there are low The information in this leaflet is levels of FVIII or abnormal If you want further information, subject to change. Please check FVIII. Individuals with low consult your doctor or with your Haemophilia levels or abnormal FVIII have Haemophilia Treatment Centre. Treatment Centre if there is any difficulty in forming blood clots, new information about this with these clots often taking About blood products medicine that you should know longer than normal to be made. since you were last treated. Sometimes the individual may Biostate® is manufactured from bleed unexpectedly into their human plasma (the liquid ® What Biostate is joints, muscles or internal component of blood) collected used for organs. by the Australian Red Cross Blood Service. When products Biostate® contains FVIII and Ask your Haemophilia are made from human blood and VWF in a purified and Treatment Centre if you have injected into you, it is possible concentrated form. Both FVIII any questions about why that viruses or other substances ® and VWF are blood proteins that Biostate has been prescribed could be present in the product for you. and cause an illness. These Biostate AU CMI 23.00 Page 1 of 7 could be viruses such as How to use Biostate® 4. Wash hands with soap and hepatitis, human water, dry with a clean immunodeficiency virus (HIV), The dosage and administration towel. or parvovirus B19 and of Biostate® must be carefully 5. Select an appropriate work theoretically the controlled. Your doctor will be area with good lighting and Creutzfeldt-Jakob Disease responsible for determining a surface which can be (CJD) agent. There could also what dose is appropriate to your cleaned (such as a kitchen be other infectious agents some condition. table). of which may not yet have been ® discovered. Biostate will usually be given 6. Using a clean cloth or paper in a hospital. Should your doctor towel, clean the preparation To reduce the risk of this decide that treatment at home is area with methylated spirits. happening, strict controls are appropriate, your Haemophilia 7. Gather the equipment to be applied when selecting blood Treatment Centre will provide used. donors and donations. In detailed instructions on how to ® addition, extra steps are taken use Biostate . Equipment when manufacturing this ® product. Biostate is specially The following procedures are One carton of Biostate® treated to remove and kill given as a guide only: containing: viruses. This special treatment is ® - one vial of Biostate® considered effective against Preparing Biostate certain viruses known as for administration - one vial of Water for enveloped viruses (such as HIV Injections and hepatitis B and C), and also You will need one 5 mL Water - one Mix2Vial™ filter the non-enveloped virus, for Injections vial for each transfer set. hepatitis A. They may be of 250 IU and 500 IU (100 IU/mL) limited value against non- vial of Biostate®, or one 10 mL Check the expiry date of each enveloped viruses such as Water for Injections vial for item. Do not use if expired. parvovirus B19. Despite these each 500 IU (50 IU/mL) and safety measures, such products 1000 IU vial of Biostate®. two alcohol wipes may still potentially transmit sharps container disease. 1. Ensure you have all the required equipment to waste container for Vaccines are available against administer Biostate®. discarding biological material some of these viruses and your 2. Allow the vials of Biostate® doctor will be able to help you and Water for Injections to plastic syringe(s) decide whether it is worthwhile reach room temperature adhesive tape having any of those vaccines. prior to use, which may take up to one hour. Do not cotton balls Please discuss the risks and warm the Water for benefits of Biostate® with your intravenous injection set Injections in hot water. doctor. gloves. 3. Remove jewellery, watches, rings, etc. Biostate AU CMI 23.00 Page 2 of 7 Instructions for cannula of the Mix2Vial™ Figure 2 ® firmly through the rubber Biostate stopper of the Water for reconstitution Injections vial. See Figure 1, (5 mL Water for Follow these steps to prepare the Injections vial is provided injection. for 250 IU vial and 500 IU (100 IU/mL) vial and 1. Wash hands with soap and 10 mL Water for Injections water, dry with a clean vial is provided for 500 IU towel. (50 IU/mL) vial and ® 2. Ensure Biostate and Water 1000 IU vial). for Injections are at room temperature. 3. Remove flip top caps from Biostate® and Water for Figure 3 Injections vials. 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 Figure 1 alcohol wipes resting on the stoppers. Do not touch the rubber stoppers with your fingers. 5. Open the lid of the Mix2Vial™ packaging. If Figure 4 the seal of the lid is not intact or you have any WFI = Water for Injections other concerns about the integrity of the 6. While holding onto the vial ™ Mix2Vial , do not use it of Water for Injections, but return it to your carefully remove the outer Haemophilia Treatment package from the Centre or Australian Red Mix2Vial™, being careful to Cross Blood Service. Place leave the Mix2Vial™ firmly the Water for Injections vial attached to the vial of Water on a level surface and hold for Injections, see Figure 2. the vial firmly. Take the Make sure that you only ™ Mix2Vial together with remove the outer package the outer package, invert it and not the Mix2Vial™. and push the blue plastic Biostate AU CMI 23.00 Page 3 of 7 7. With the Biostate® vial held 8. With the Water for 11. Once the Biostate® has been firmly on a level surface, Injections and Biostate® transferred into the syringe, invert the Water for vials still attached to the firmly hold the barrel of the Injections with the Mix2Vial™, gently swirl (do syringe (keeping the syringe Mix2Vial™ attached and not shake) the Biostate® plunger facing down) and push the transparent plastic vial until all of the product detach the Mix2Vial™ from cannula end of the is dissolved. Ensure the the syringe. Do not use the Mix2Vial™ firmly through contents of the vial are Mix2Vial™ for injection. the stopper of the Biostate® completely dissolved. If a Note: One large syringe vial, see Figure 3. The clot or gel forms do not use may be used to withdraw water will be drawn into the the product but return it to Biostate® from multiple vial by the vacuum your Haemophilia vials. contained within the Treatment Centre or ® Biostate vial. If water is Australian Red Cross Blood 12. Discard the empty vial of not drawn into the vial, it Service. Biostate® with the means that there is no 9. Once the contents of the transparent part of the vacuum in the vial and the ™ Biostate® vial are Mix2Vial attached, into an seal may be faulty. Do not completely dissolved, appropriate waste container. use the product but return firmly hold both the it to your Haemophilia ® transparent and blue parts Use Biostate as soon as you Treatment Centre or the of the Mix2Vial™. Unscrew can after preparation. (Make Australian Red Cross the Mix2Vial™ into two sure it is used for one person Blood Service. separate pieces, see on one occasion only). The Note: The Mix2Vial™ is Figure 4. Discard the solution must not be stored for intended to filter the empty Water for Injections longer than 8 hours and the contents of a single vial of vial with the blue part of the infusion should be completed Biostate® only. If multiple Mix2Vial™ still attached as soon as practicable, as ® vials of Biostate® are to be into an appropriate waste Biostate does not contain an given, a separate container. antimicrobial preservative. Mix2Vial™ must be used Any unused portion remaining 10. While the Biostate® vial is for each vial. in the vial must be discarded upright, attach a plastic appropriately. disposable syringe to the transparent part of the Do not refrigerate Biostate® Mix2Vial™. Invert the once it has been prepared. system and draw the Biostate® into the syringe Injection by pulling the plunger back administration slowly.
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