500 U powder and solvent for solution for injection
susoktokog alfa<\/p>\n\n\n\n
OBIZUR contains the active substance susoktokog alfa, anti-\u00a0hemophilia\u00a0factor VIII, porcine sequence.\u00a0Factor VIII is needed for the blood to coagulate and stop bleeding.<\/p>\n\n\n\n
In patients with acquired\u00a0hemophilia,\u00a0factor VIII\u00a0does not work properly because the patient has developed\u00a0antibodies\u00a0to their factor VIII that neutralize this blood coagulation factor.<\/p>\n\n\n\n
OBIZUR is used to treat bleeding in adults with acquired\u00a0hemophilia\u00a0(a bleeding disorder caused by a lack of factor VIII activity due to the development of\u00a0antibodies\u00a0).\u00a0These\u00a0antibodies\u00a0have a less neutralizing effect against OBIZUR than against human factor VIII.<\/p>\n\n\n\n
OBIZUR restores the missing factor VIII activity and helps the blood to coagulate at the bleeding site.<\/p>\n\n\n\n
If you are not sure, talk to your doctor before taking this medicine.<\/p>\n\n\n\n
This medicine is only to be given to patients in a hospital.\u00a0It requires monitoring of the patient’s bleeding status.<\/p>\n\n\n\n
Talk to your doctor before giving OBIZUR.<\/p>\n\n\n\n
Hypersensitivity<\/p>\n\n\n\n
There is a small risk that you may have an allergic reaction to OBIZUR. You should be aware of the early signs of allergic reactions (signs and symptoms can be found in section 4). If any of these symptoms occur, the injection should be stopped. Serious symptoms, including difficulty breathing and (almost) fainting, require urgent hospital treatment.<\/p>\n\n\n\n
Inhibitors<\/p>\n\n\n\n
Your doctor may check if you have inhibitory antibodies to porcine factor VIII<\/p>\n\n\n\n
and if these antibodies are increasing.<\/p>\n\n\n\n
Your doctor will check the presence of factor VIII in your blood to confirm that you have had enough factor VIII. The doctor will also check if the bleeding is under satisfactory control.<\/p>\n\n\n\n
Cardiovascular events<\/p>\n\n\n\n
Talk to your doctor if you currently have or have had cardiovascular disease or if you have a known risk of thrombosis (a disease caused by blood clots in the blood vessels), as the risk of developing blood clot-related diseases at high and persistent factor VIII levels cannot be ruled out.<\/p>\n\n\n\n
Children <\/strong>and <\/strong>young people<\/strong><\/em><\/strong><\/p>\n\n\n\n There is no information on the use of OBIZUR in children and adolescents under 18 years of age.<\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines.\u00a0No\u00a0interaction\u00a0between OBIZUR and other drugs is known.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.<\/p>\n\n\n\n OBIZUR does not affect the ability to drive and use machines.<\/p>\n\n\n\n After\u00a0reconstitution, this medicinal product contains 4.6 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per milliliter.\u00a0This corresponds to 0.23% of the maximum recommended daily\u00a0sodium\u00a0intake for adults.\u00a0Several vials must be taken per\u00a0dose.<\/p>\n\n\n\n Tell your doctor if you have been prescribed a low-salt diet.<\/p>\n\n\n\n The treatment with OBIZUR is carried out by a doctor who has experience in caring for patients with\u00a0hemophilia\u00a0(bleeding disorders).<\/p>\n\n\n\n Your doctor will calculate your\u00a0dose\u00a0of OBIZUR (in units or E) depending on your condition and your body weight.\u00a0How often and for how long you receive treatment depends on how well OBIZUR works for you.\u00a0In most cases, replacement therapy with OBIZUR is a temporary treatment until the bleeding has stopped or the\u00a0antibodies\u00a0to your factor VIII have been removed.<\/p>\n\n\n\n Your doctor will check for the presence of antibodies to OBIZUR.<\/p>\n\n\n\n The recommended starting dose is 200 U per kilogram body weight, given as an\u00a0intravenous\u00a0injection.<\/p>\n\n\n\n Your doctor will measure your factor VIII activity regularly to determine the next dose and how often you should receive OBIZUR.<\/p>\n\n\n\n The bleeding usually responds within the first 24 hours. Your doctor will adjust the dose one and the duration of OBIZUR until the bleeding has stopped.<\/p>\n\n\n\n The full volume of reconstituted (reconstituted) OBIZUR should be given at a rate of 1 to 2 ml per minute.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n In the event of a severe and sudden\u00a0allergic reaction,\u00a0injection\u00a0must\u00a0be stopped immediately.\u00a0If any of the following early symptoms occur, you must contact a doctor immediately:<\/p>\n\n\n\n Very common side effects (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton, vial, and prefilled syringe after EXP.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C).<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n The reconstituted solution should be used immediately, but no later than 3 hours after the powder has completely dissolved.<\/p>\n\n\n\n After\u00a0reconstitution, the solution should be clear and colorless.<\/p>\n\n\n\n Do not administer it if there are particles or discoloration.<\/p>\n\n\n\n As this medicine is used during a hospital stay, the hospital staff is responsible for the proper storage of this medicine before and during its use, as well as for proper disposal.<\/p>\n\n\n\n Name and batch number<\/p>\n\n\n\n It is strongly recommended that each time OBIZUR is administered to a patient, the name and manufacturing batch number of the medicinal product should be noted so that a link between the patient and the manufacturing batch number of the medicinal product can be maintained.<\/p>\n\n\n\nOther medicines and OBIZUR<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
OBIZUR contains sodium<\/h2>\n\n\n\n
How OBIZUR is given<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store OBIZUR<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n