Patient Information Leaflet

REPLENINE -VF A HIGH PURITY FACTOR IX

FJL10

Please read this carefully before using this medicine. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor. What is in your medicine? The name of your medicine is Replenine-VF, a High Purity Factor IX. It is a concentrate of human Factor IX prepared from blood plasma from screened donors and is chemically treated and virus filtered to destroy viruses. These donors are selected from the USA. It is a white crumbly solid. It is available as single dose vials containing either 250, 500 or 1000 iu of its active ingredient called human factor IX. The medicine is supplied with a vial of water (5ml with the 250 iu vial, 10ml with the 500 iu vial and 20ml with the 1000 iu vial). The product is for intravenous injection (injection into a vein) and is available on a doctors prescription. In addition to the active ingredient the product also contains small amounts of other plasma proteins, glycine, lysine, sodium, chloride, citrate and phosphate salts, polysorbate 80 and tri-n-butyl phosphate. The product is manufactured and marketed by: BPL, Bio Products Laboratory, Dagger Lane, Elstree, Herts, WD6 3BX. What is your medicine used for? To prevent and control bleeding in patients with Haemophilia B. Your doctor can explain why this medicine has been given to you. When should you NOT use this medicine? The medicine should not be given to you if you show signs of bruising, or if your liver is not working properly. In these cases you will require specialist medical attention. Your doctor will advise you. When you should be careful about using this medicine. Some patients who have been lacking in Factor IX from birth may develop antibodies to Factor IX after treatment. This could mean that the treatment will not work properly. One way to tell if these inhibitors have formed is if bleeding does not stop after an injection. If you think this may be happening then speak to your doctor. Your doctor will check regularly for the development of inhibitors, especially before you have an operation. Tests to check the levels of Factor IX in your blood will probably be carried out before and after treatment; particularly during the first course of treatment. Experience in the past with low purity Factor IX products (prothrombin complex concentrate) has shown a potential risk of bruising or clots in the blood when patients are treated with such medicines. However, clinical experience to date suggests that such risks are reduced in patients given highly purified Factor IX medicines. Nevertheless, because of the potential risk of blood clotting, your doctor will be extra careful when prescribing this medicine to you if you have a history of heart or liver disease, or after any operation you have had, or to you if you are at risk of clots forming in your blood or you bruise easily. In each of these situations, your doctor will advise you on the appropriate medicines to take. The doctor will also be extremely careful about prescribing this medicine for a baby. Once the medicine is made up with the water it should be used within one hour. The solution should not be added to any other fluids, blood or other medicines as their effects on the product are not known. Sterilised Water for Injections, Ph. Eur. is only to be used for dissolving your medicine and must not be injected on its own. This product must only be injected as instructed by your doctor. You must tell your doctor if you are pregnant or breast-feeding. There are no known effects of this product on the ability to drive or operate machinery. When medicinal products prepared from human blood or plasma are administered to patients, the risk of infectious diseases caused by certain viruses, known and unknown, cannot be totally ruled out. To reduce the risk of infection, strict controls are applied to the selection of blood donors and donations. In addition, steps to remove and/or destroy viruses are included in the manufacture of the product. These steps are effective against the AIDS virus, liver disease viruses (such as hepatitis B, hepatitis C and hepatitis A), parvovirus and other known viruses carried in blood. Your doctor will advise you which vaccinations you should be given as a routine precaution because you are receiving a plasma product. How much of your medicine do you give? DO NOT EXCEED THE ADVISED DOSE The number of units needed and the duration of the treatment depend upon the condition being treated. The table below gives the approximate doses of Factor IX in this medicine which are needed to stop bleeding for various conditions: The doses shown are only rough guides. Your doctor will explain to you how much you should take. It is usual to give the total contents in the

Condition Minor spontaneous bleeding in joints and muscles Severe bleeding in joints and muscles, haematoma (swelling caused by collection of blood) and blood in the urine. Minor surgery, e.g. dental extractions, arthrotomy etc. Major surgery, bleeding in potentially dangerous situations

Initial dose of Factor IX (iu/kg bodyweight) 25

25 to 45 45 to 75

number of whole vials nearest to the appropriate dose. Your doctor will advise you on how frequently you should take the medicine. How much do you give a child? Your doctor will tell you how much to give.

Dissolving the medicine. The medicine should only be dissolved with the water provided with the product. The vial of medicine and the vial of water supplied should be brought to room temperature (between 20C and 30C), before removing the flipoff closures. Remove these caps from the concentrate and water vials and clean the stoppers with a spirit swab. Either of the following methods for dissolving the medicine can then be used. a) Using a sterile needle and syringe, which must be disposed of carefully after use, draw up the required volume of water (2.5ml or 5ml for 250 iu, 5ml or 10ml for 500 iu and 10ml or 20ml for 1000 iu) and transfer to the vial of medicine. On piercing the seal of the medicine vial, the water will be drawn into the vial which is under vacuum. NB: THE FILTER NEEDLE PROVIDED MUST NOT BE USED TO DRAW UP THE WATER FOR INJECTIONS. or b) Remove the cover guard from one end of a double ended transfer needle and insert through the stopper into the vial of water. Remove the other end of the needle guard, invert the water vial over the medicine vial and insert the free end of the needle through the stopper into the vial of product. On piercing the seal of the medicine vial, the water will be drawn into the vial of medicine which is under vacuum. A small amount of water will remain in the water vial. This method cannot be used to prepare the infusion at reduced volume (see above). If the water is not drawn into the vial containing the medicine, this shows a loss of vacuum. If the vial does not contain a vacuum or if the dissolved product forms a gel or a clot, it must not be used and Bio Products Laboratory should be advised. The medicine vial should be swirled to wet the product and the vacuum then released by either: i) Removing the syringe from the needle before removing the needle from the medicine vial, or ii) Disconnecting the two vials by first removing the transfer needle from the water vial and then removing the transfer needle from the medicine vial. The product dissolves rapidly and requires only very gentle swirling. A clear or slightly shiny solution should be obtained within 5 minutes. If a gel or clot forms give the vial to your doctor or pharmacist. Should more than one vial be required to make up the dose, the contents of the required number of vials are pooled together. The solution should be used immediately, and injection must be completed within one hour. Throw away any unused water. Do not use solutions which are cloudy or have deposits. After dissolving the medicine, it should be injected immediately, as instructed in the Injection of the medicine section below. Injection of the medicine. Once the medicine is in solution, clean the stopper with a spirit swab. The dissolved medicine should be drawn from the vial into a plastic throw-away syringe (approved syringes are made by Becton Dickinson) through the sterile filter needle provided which will remove any small particles. To inject the medicine attach a suitable needle or butterfly (an Abbott Venisystems butterfly is approved) to the syringe. Although this medicine is unlikely to cause side effects, the dose, especially the first dose, should be given slowly (approximately 3ml per minute). If you need more than one vial of medicine you may pool the contents of the correct number of vials into an appropriate size syringe by drawing up the contents of each vial through a separate sterile filter needle. A new sterile filter needle should be used for each vial. The solution must not be stored and injection of each dose into the vein should be completed within one hour of dissolving the medicine. Safely throw away any used or unused material. You should ask your doctor for a special container for this purpose. This medicine should be administered when the first sign of bleeding occurs and should be repeated as necessary to stop the bleeding. Each individual case should be judged on its own severity. What to do if you give yourself too much. If the appropriate dose is exceeded, stop the injection and tell your doctor. Can Replenine-VF cause side effects? Any medicine can cause side effects, however, most people who use Replenine-VF have no problems. If you think you might have experienced a side effect, please tell your doctor. The following side effects have been experienced occasionally: Headache, nausea (feeling sick), shortness of breath, stinging at injection site, chills, flushing, rash, swelling, tiredness, faster heart rate, pins and needles. If you have any of the above symptoms, stop the infusion and speak to your doctor urgently. If the medicine does not stop the bleeding or the pain you must also speak to your doctor. How to store the medicine. This product should be stored between 2C and 8C in the fridge in its carton, in the dark. It must not be used after the expiry date shown on the box. Short periods of storage at room temperature, in the dark, will not damage the product. The vial of water that comes with the medicine should be stored between 2C and 25C and must not be used after the expiry date shown on the box or if any particulate matter (small bits) can be seen. Once made up with the water, Replenine-VF, must be used within one hour. Further information. For further information on the use and form of this product please contact BPL via the Marketing Department at the address below.

Manufactured and Marketed by:

Bio Products Laboratory Dagger Lane, Elstree, Herts. WD6 3BX, UK. Tel: 020 8258 2200 DATE OF LEAFLET PREPARATION January 2003 : Registered Trade Mark FJL10