650 IU\/1300 IU\u00a0powder and liquid for\u00a0injection, solution
voicing alfa<\/p>\n\n\n\n
VEYVONDI contains the active substance vonicog alfa, a\u00a0recombinant\u00a0human\u00a0von Willebrand factor (VFW).\u00a0The drug behaves in the same way as the natural\u00a0human\u00a0von Willebrand factor (VWF) in the body.\u00a0VWF is a\u00a0carrier molecule\u00a0for\u00a0coagulation factor\u00a0VIII and is involved in blood clotting, by making platelets stick to wounds so that the blood clots.\u00a0Lack of VWF increases the tendency to bleed.<\/p>\n\n\n\n
VEYVONDI is used to treat and control bleeding episodes and to prevent bleeding during surgical procedures in adult patients (18 years of age or older) diagnosed with\u00a0von Willebrand disease.\u00a0It is used when treatment with another drug, desmopressin, is not effective or cannot be given.<\/p>\n\n\n\n
Von Willebrand disease\u00a0is an inherited bleeding disorder caused by the absence or insufficient amount of von Willebrand factor.\u00a0In patients with the disease, the blood does not clot normally, which leads to a longer bleeding time.\u00a0Administration\u00a0of the von Willebrand factor (VWF) makes it possible to correct von Willebrand factor deficiency.
<\/p>\n\n\n\n
Consult a doctor if you are unsure.<\/a><\/p>\n\n\n\n Talk to your doctor before using VEYVONDI.<\/p>\n\n\n\n There is a risk that you may have a\u00a0hypersensitivity reaction\u00a0(a severe, sudden\u00a0allergic reaction\u00a0) when using VEYVONDI.\u00a0Your doctor should inform you of early signs of serious allergic reactions, such as increased heart rate, rash,\u00a0hives, hives, general\u00a0itching, swelling of the lips and tongue, difficulty breathing, wheezing, tightness in the chest, fast heartbeat, stuffy nose, red eyes, general malaise, and dizziness.\u00a0These can be early symptoms of a\u00a0hypersensitivity reaction.\u00a0If any of these symptoms occur, immediately stop the\u00a0infusion one and contact a doctor.\u00a0Severe symptoms, including difficulty breathing and dizziness, require immediate\u00a0emergency\u00a0treatment.<\/strong><\/p>\n\n\n\n Patients who develop inhibitors<\/em><\/p>\n\n\n\n In some patients who receive the drug, inhibitors ( antibodies ) against VWF may form. The inhibitors can, especially at high levels, prevent the treatment from working as it should. You will be closely monitored for the development of such inhibitors.<\/p>\n\n\n\n If the expected levels of VWF or\u00a0factor VIII\u00a0in\u00a0plasma\u00a0are not achieved with VEYVONDI according to the test results observed by your doctor, or if the bleeding is not properly controlled, it may be due to the presence of VWF or\u00a0factor\u00a0VIII\u00a0antibodies.\u00a0Your doctor will check this.\u00a0You may need to increase the\u00a0dose\u00a0of VEYVONDI, or increase the\u00a0dose\u00a0of\u00a0factor VIII, or even change to another medicine to control the bleeding.\u00a0Do not increase the total\u00a0dose\u00a0of VEYVONDI to control bleeding without consulting your doctor.<\/p>\n\n\n\n If you have previously been treated with plasma-derived VWF concentrate, you may have a reduced response to VEYVONDI due to pre-existing\u00a0antibodies.\u00a0Your doctor may need to adjust your\u00a0dose\u00a0based on your lab results.<\/p>\n\n\n\n Thromboembolism and embolism<\/em><\/p>\n\n\n\n There is a risk of thrombotic events if you have risk factors that have been demonstrated clinically or in the laboratory.\u00a0Therefore, your doctor will monitor you for early signs of\u00a0thrombosis.<\/p>\n\n\n\n FVIII products may contain varying amounts of VWF. Therefore, an FVIII product administered in combination with VEYVONDI must be a pure FVIII product.<\/p>\n\n\n\n If you have previously had problems with blood clots or vessel narrowing (thromboembolic complications), you should tell your doctor immediately.<\/em><\/p>\n\n\n\n VEYVONDI is not approved for use by children and adolescents under the age of 18.<\/a><\/p>\n\n\n\n Tell your doctor if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.<\/p>\n\n\n\n VEYVONDI is unlikely to affect your ability to drive or use machines.<\/a><\/p>\n\n\n\n This medicinal product contains 5.2 mg\u00a0sodium\u00a0in each 650 IU\u00a0vial\u00a0and 10.4 mg\u00a0sodium\u00a0in each\u00a01300 IU vial.<\/p>\n\n\n\n This corresponds to 2.2% of the recommended maximum daily intake of dietary sodium for adults with an estimated body weight of 70 kg and a dose of 80 IU\/kg.<\/p>\n\n\n\n This should be taken into account if you have been prescribed a low-sodium diet. Treatment with VEYVONDI will be supervised by doctors experienced in treating patients with\u00a0von Willebrand disease.<\/p>\n\n\n\n The doctor will calculate your\u00a0dose\u00a0of VEYVONDI (in international units or IU).\u00a0Does\u00a0one depends on:<\/p>\n\n\n\n The doctor can perform appropriate blood tests to make sure you have the right levels of von Willebrand factor. This is especially important if you are going to have major surgery.<\/p>\n\n\n\n Treatment of bleeding episodes:<\/strong><\/em><\/p>\n\n\n\n The doctor will calculate the\u00a0dose\u00a0that is most suitable for you, how often you should receive VEYVONDI, and for how long.<\/p>\n\n\n\n For minor bleeding (e.g. epistaxis, bleeding in the mouth, heavy menstruation) each starting dose is usually 40 \u2013 50 IU\/kg and for major bleeding (severe or refractory epistaxis, heavy and frequent menstruation, gastrointestinal bleeding, trauma to the\u00a0central nervous system, hemarthrosis or traumatic bleeding) each starting dose is 50-80 IU\/kg.\u00a0Loading doses (according to clinical need) are 40 \u2013 50 IU\/kg every 8 to 24 hours for minor bleeding as long as considered clinically necessary and for major bleeding 40 \u2013 60 IU\/kg for approximately 2 \u2013 3 days.<\/p>\n\n\n\n Talk to your doctor if you feel that VEYVONDI is not working well enough. Your doctor performs appropriate laboratory tests to make sure you have the right levels of von Willebrand factor. If you use VEYVONDI at home, your doctor will make sure you have been shown how to infuse it and how much to use.<\/p>\n\n\n\n Prevention of bleeding in case of the elective surgery:<\/strong><\/em><\/p>\n\n\n\n Within 3 hours before surgery, your doctor assesses FVIII: C levels to prevent heavy bleeding.\u00a0If your FVIII level is not sufficient, your doctor may give you a\u00a0dose\u00a0of 40-60 IU\/kg of VEYVONDI 12-24 hours (\u00a0preoperative\u00a0dose\u00a0) before the elective surgical procedure to raise the FVIII levels to the target level (0.4 IU \/ml for minor and at least 0.8 IU\/ml for major procedures).\u00a0Within 1 hour before surgery, you will receive a\u00a0dose\u00a0of VEYVONDI based on the evaluation 3 hours before surgery.\u00a0The dose\u00a0depends on the patient’s VWF and FVIII levels, the type of bleeding, and how severe the bleeding is expected to be.<\/p>\n\n\n\n How to get VEYVONDI<\/strong><\/p>\n\n\n\n VEYVONDI is usually infused into a vein ( intravenously ) by a doctor or nurse. Detailed instructions for preparation and administration can be found at the end of this leaflet.<\/a><\/p>\n\n\n\n VEYVONDI is not approved for use by children and adolescents under the age of 18.<\/a><\/p>\n\n\n\n Always use this medicine as directed by your doctor.\u00a0Consult a doctor if you are unsure.\u00a0If you infuse more VEYVONDI than recommended, talk to your doctor as soon as possible.\u00a0There is a risk of developing blood clots (\u00a0thrombosis\u00a0) at an unintentionally high\u00a0dose.<\/p>\n\n\n\n Do not stop using VEYVONDI without consulting your doctor.<\/p>\n\n\n\nWarnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and VEYVONDI<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
VEYVONDI contains sodium<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to use VEYVONDI<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you have used too much VEYVONDI<\/h2>\n\n\n\n
If you forget to use VEYVONDI<\/h2>\n\n\n\n
If you stop using VEYVONDI<\/h2>\n\n\n\n