Biostate® Human factor VIII (FVIII) and human (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 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. procedure guidelines

The injection is best given by following each of the steps outlined in turn.

Biostate AU CMI 23.00 Page 4 of 7 Should any of the symptoms 13. Apply pressure to the  feeling sick or vomiting listed under ‘Side effects’ injection site using a cotton  strange taste in the mouth develop, stop the infusion ball for one to two minutes. immediately and contact your Apply dressing if necessary.  irritation of the vein used Haemophilia Treatment for infusion (which may 14. Discard all used sharps into Centre. include swelling, redness or the sharps container, and tenderness) dispose of the other used 1. Apply tourniquet. Select equipment appropriately.  shortness of breath or injection site. difficulty breathing. 15. Wash hands with soap and 2. Wash hands with soap and water, dry with a clean water, dry with a clean Contact your doctor towel. towel. immediately if you experience any of these symptoms at any 3. Cleanse the skin area with Side effects time: an alcohol wipe, allow to dry. Along with their intended  fever effects, medicines may cause 4. Put on gloves. some unwanted effects, which  loss of appetite 5. Insert intravenous needle can sometimes be serious.  extreme tiredness into vein. Furthermore, individual patients 6. Secure needle with adhesive may react differently to the  abdominal pain tape. same dose of the same medicine.  jaundice (yellow skin and This applies to Biostate®, 7. Attach the syringe eyes) although severe reactions after ® containing Biostate to the ® Biostate injection are rare. Ask  dark urine intravenous needle. your Haemophilia Treatment  joint pains 8. Gently pull back the Centre if you need more plunger until the tubing is information.  skin rashes. filled with blood. Stop using this product Inhibitors 9. Release the tourniquet. immediately and contact your Treatment with factor VIII 10. Administer the Biostate® doctor if any of the following products such as Biostate® may solution slowly (usually side effects occur: sometimes lead to the formation within 5 minutes, or as of (inhibitors) which tolerated).  headache neutralise factor VIII and reduce 11. Carefully remove adhesive  pain (such as back pain, the effectiveness of the tape. joint pains and bone pains) treatment. Your doctor will 12. Carefully remove the  dizziness monitor you for development of intravenous needle with these inhibitors and if they  anxiety syringe attached and place suspect that an inhibitor is directly into the sharps  reddening of the face or present, the level of inhibitor container. neck will be measured using the appropriate laboratory tests. In  chest pain some patients, inhibitors can be  sweating successfully overcome with

Biostate AU CMI 23.00 Page 5 of 7 larger doses of factor VIII, but in four presentations. Each pack  sodium chloride for some patients it may be size contains:  trometamol necessary to switch to a ® different treatment. 1. 250 IU vial of Biostate  calcium chloride (with a FVIII concentration  sodium octanoate Overdose of 50 IU/mL and a VWF concentration of  human albumin Cases of overdose have been 120 IU/mL), 5 mL vial of  human plasma proteins. observed. No severe adverse Water for Injections, and a reactions were associated with special filter transfer set This product is packaged in these cases. The risk of called a Mix2Vial™. latex free materials. thromboembolic events cannot 2. 500 IU vial of Biostate® be excluded in cases of major (with a FVIII concentration overdose, especially in patients Manufacturer of 50 IU/mL and a VWF with VWD. If you have any Biostate® is manufactured in concentration of questions, consult your doctor. Australia by: 120 IU/mL), 10 mL vial of Water for Injections, and a ® CSL Behring (Australia) Pty Ltd Storing Biostate special filter transfer set ABN 48 160 734 761 called a Mix2Vial™. Store at 2°C to 8°C (Refrigerate. 189–209 Camp Road ® Do not freeze). Biostate can be 3. 500 IU vial of Biostate®, Broadmeadows VIC 3047 stored at 25°C or below for a (with a FVIII concentration Australia single period of 6 months. The of 100 IU/mL and a VWF product must not be returned to concentration of Distributor refrigeration after storage at 240 IU/mL), 5 mL vial of 25°C or below. Protect from Water for Injections, and a Australian Red Cross Blood light. special filter transfer set Service called a Mix2Vial™. Do not use after the expiry date. Date of most recent 4. 1000 IU vial of Biostate®, amendment Further information (with a FVIII concentration of 100 IU/mL and a VWF June 2017 This is not all the information concentration of ® that is available on Biostate . If 240 IU/mL), 10 mL vial of Australian Register Numbers you have any more questions or Water for Injections, and a 250 IU FVIII/500 IU VWF: are not sure about anything, ask special filter transfer set AUST R 73032 ™ your Haemophilia Treatment called a Mix2Vial . 500 IU FVIII/1000 IU VWF: Centre. AUST R 79993 Ingredients 500 IU FVIII/1000 IU VWF: Product description AUST R 150648 Biostate® contains FVIII and 1000 IU FVIII/2000 IU VWF: VWF as the active ingredients. What it looks like AUST R 150657 It also contains: Biostate® is a white or pale ® Registered trademark of CSL yellow powder contained in a  sucrose Limited glass vial. Biostate® is registered  sodium citrate

Biostate AU CMI 23.00 Page 6 of 7 ™ Mix2Vial is a trademark of West Pharmaceutical Services, Inc. or a subsidiary thereof

Biostate AU CMI 23.00 Page 7 of 7