25 U \/ ml, 50 U \/ ml. Powder and solvent for solution for infusion.
Factor VIII Inhibitor Bypassing Activity<\/p>\n\n\n\n
Feiba is a preparation made from human plasma that allows the blood to stop, even when individual coagulation factors are reduced or absent.
<\/p>\n\n\n\n
Feiba is used to treat bleeding in hemophilia A patients with inhibitors.<\/p>\n\n\n\n
Feiba is used to treat bleeding in hemophilia B patients with inhibitors if no other specific treatment is available.<\/p>\n\n\n\n
Feiba is also used to prevent bleeding in hemophilia A patients with inhibitors who have experienced major bleeding or are at high risk for major bleeding.<\/p>\n\n\n\n
Feiba can also be used to treat non- hemophilia patients who have acquired factor VIII inhibitors.
<\/p>\n\n\n\n
Tell your doctor if you have a known allergy.
<\/p>\n\n\n\n
Tell your doctor if you are on a low sodium diet.
<\/p>\n\n\n\n
Do not use Feiba<\/strong> In the following situations, Feiba should only be used if, for example, due to the very high titer of inhibitors, a response to the expected coagulation factor concentrate cannot be obtained as expected. Talk to your doctor before using Feiba as hypersensitivity reactions may occur, as with any intravenously administered plasma product. To recognize an allergic reaction as soon as possible, you should be aware of potential early signs of a hypersensitivity reaction, such as<\/p>\n\n\n\n Other symptoms of hypersensitivity reactions to products made from plasma are persistent unconsciousness ( lethargy ) and restlessness. If you notice any of these symptoms occurring, stop the infusion immediately and consult a doctor. The above symptoms may be early signs of anaphylactic shock. Severe symptoms require immediate emergency treatment. Your doctor will only treat you again if you suspect hypersensitivity to the product or any of its components after carefully considering the expected benefit against the risk of reintroduction and\/or if no reaction can be expected with other preventive treatment or alternative medicines. The occurrence of blood clots that may end up in the bloodstream (thrombotic and thromboembolic events), including multiple intravascular coagulation ( DIC ), blockages in the veins due to blood clots ( venous thrombosis ), blood clots in the lung ( pulmonary embolism ), heart attack and stroke have occurred during treatment with Feiba. Concomitant use of recombinant factor VIIa is likely to increase the risk of developing a blood clot that enters the bloodstream (thromboembolic event). Some of the thromboembolic events have occurred during treatment with high doses of Feiba. In a study conducted by another company, which examined emicizumab (a drug to prevent bleeding in patients with hemophilia A), some patients suffering from breakthrough bleeding were treated with Feiba to control the bleeding, and a few of these patients developed thrombotic microangiopathy. (TMA). TMA is a serious and potentially life-threatening condition. When you have this condition, the walls of the blood vessels can be damaged and blood clots form in small blood vessels. In some cases, this can damage the kidneys and other organs. If you experience breakthrough bleeding when using emicizumab as preventative medicine, contact your hemophilia doctor or hemophilia center immediately. When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes a careful selection of blood and plasma donors to ensure that those at risk of carrying an infection are excluded and that each plasma pool donation is tested for signs of virus\/infection. The manufacturers of these products also include steps in the processing of blood and plasma that can inactivate or secrete viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs are made from human blood or human plasmas. This also applies to new, hitherto unknown viruses and other types of infection.<\/p>\n\n\n\n The measures taken are considered effective for enveloped viruses, e.g. human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus and for the non-enveloped hepatitis A virus et. The measures may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious in pregnant women ( fetal infection ) and individuals with a weakened immune system or patients with certain anemia (eg sickle cell disease or hemolytic anemia ). Your doctor may recommend that you consider hepatitis A and B vaccination if you regularly or repeatedly receive factor VIII inhibitors derived from human plasma.<\/p>\n\n\n\n Following administration of high doses of Feiba, a transient increase in passively transmitted hepatitis B surface antibodies may lead to misinterpretation of positive results in serological tests. Feiba is a product made from plasma and may contain substances that react when given to a patient, which can lead to the formation of isohemagglutinins ( antibodies that cause red blood cells from another person to clot). This can lead to misleading results on blood tests. It is strongly recommended that you note the name and batch number of Feiba at each treatment session to maintain a connection between you and the product batch number.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No adequate and well-controlled studies of the combined or sequential use of Feiba and recombinant factor VIIa, antacids (antifibrinolytics), or emicizumab have been performed. The possibility of blood clots should be considered when using systemic antifibrinolytics such as tranexamic acid and aminocaproic acid during treatment with Feiba. Therefore antifibrinolytics not be used for about 6 to 12 hours after administration of Feiba. When co-administered with rFVIIa, potential drug interaction cannot be ruled out according to available in vitro<\/em> data and clinical observations, which could potentially lead to a thromboembolic event. <\/em>Tell your doctor if you are to be treated with Feiba after receiving emicizumab (a medicine that prevents bleeding in patients with hemophilia A) as certain warnings and precautions must be followed. Your doctor must monitor you closely. Like all blood coagulation preparations, Feiba should not be mixed with other medicinal products before administration, as the efficacy and tolerance of the preparation may be impaired. It is recommended that joint vein access be flushed with physiological saline before and after administration of Feiba.<\/p>\n\n\n\n Doctors decide if Feiba can be used during pregnancy and breast-feeding. Due to the increased risk of thrombosis during pregnancy, Feiba should only be administered under close medical supervision and only if necessary. Information on parvovirus B19 infection is provided in the Warnings and Precautions section.<\/p>\n\n\n\n There is no evidence that Feiba can affect the ability to drive and use machines.<\/p>\n\n\n\n Feiba 25 U \/ ml:<\/strong> 500 U<\/p>\n\n\n\n This medicine contains 80 mg of sodium (the main ingredient in table salt\/table salt) per vial. This corresponds to 4% of the maximum recommended daily intake of sodium for adults. Feiba 50 U \/ ml:<\/strong> 500 U<\/p>\n\n\n\n This medicine contains 40 mg sodium (the main ingredient in table salt\/table salt) per vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults. 1000 U<\/p>\n\n\n\n This medicine contains 80 mg of sodium (the main ingredient in table salt\/table salt) per vial. This corresponds to 4% of the maximum recommended daily intake of sodium for adults. 2500 U<\/p>\n\n\n\n This medicine contains 200 mg of sodium (the main ingredient in table salt\/table salt) per vial. This corresponds to 10% of the maximum recommended daily intake of sodium for adults. Reconstitute the lyophilized Feiba powder in the supplied diluent and administer the solution intravenously. Always use Feiba exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will decide on the dosage one, how often you should be treated and the duration of the treatment, depending on the severity of your coagulation disorder, the location, and extent of the bleeding, and the condition. Do not change the dosage prescribed by your doctor and do not stop using the preparation on your own. Talk to your doctor or pharmacist if you have the impression that the effect of Feiba is too strong or too weak. Warm the product to room or body temperature before administering one if necessary. Feiba should be reconstituted immediately before administration. The solution should be used immediately (as the preparation does not contain any preservative ). Gently swirl the bottle until all the powder has dissolved. Make sure that Feiba dissolves completely, otherwise fewer Feiba units will pass through the device’s filter. Solutions that are cloudy or have precipitated material should be disposed of appropriately. Do not reuse opened containers. Use only the supplied water for injections and the kit provided for reconstitution. If devices other than those provided are used, check that a suitable filter with a pore size of at least 149 \u00b5m is used. Do not use the product if the sterile barrier has been broken, the packaging is damaged, or if it shows signs of deterioration. Any unused product or waste material should be disposed of by local requirements. Reconstitution of the powder to prepare an infusion solution with BaxJect II Hi-Flow:<\/strong><\/p>\n\n\n\n <\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nWarnings and cautions<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/li><\/ul>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nOther drugs and Feiba<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Feiba contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n3. How to use Feiba<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n