Nuwiq 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 2500 IU, 3000 IU, and 4000 IU powder and solvent for solution for injection
simoctocog alfa (\u00a0recombinant\u00a0human\u00a0coagulation factor\u00a0VIII)<\/p>\n\n\n\n
Nuwiq contains the active substance\u00a0recombinant\u00a0human\u00a0coagulation factor\u00a0VIII (simoctocog alfa).\u00a0Factor VIII\u00a0is needed for the blood to coagulate and stop bleeding.\u00a0In patients with\u00a0hemophilia\u00a0A (congenital\u00a0factor VIII deficiency),\u00a0factor VIII\u00a0is missing\u00a0or does not function normally.<\/p>\n\n\n\n
Nuwiq\u00a0\u00ae<\/sup>\u00a0replaces the missing\u00a0factor VIII\u00a0and is used to treat and prevent bleeding in patients with\u00a0hemophilia\u00a0A and is suitable for use by all age groups.<\/p>\n\n\n\n Contact your doctor for questions about the above.<\/p>\n\n\n\n Talk to your doctor before using Nuwiq.<\/p>\n\n\n\n In very rare cases, an anaphylactic reaction to Nuwiq \u00ae<\/sup> may occur (a severe, sudden allergic reaction ). You should be aware of these early signs of allergic reactions, which are listed in section 4 “Allergic reactions”. Discontinue injection immediately and consult a physician if you notice any of the following symptoms.<\/p>\n\n\n\n The development of inhibitors (\u00a0antibodies\u00a0) is a known complication that can occur during treatment with any\u00a0factor VIII\u00a0drug.\u00a0The inhibitors prevent, especially at high levels, that the treatment works properly.\u00a0You or your child will be closely monitored for the development of such inhibitors.\u00a0If you or your child suffer from bleeding that cannot be controlled with Nuwiq, tell your doctor immediately.<\/p>\n\n\n\n Cardiovascular disease Catheter-related complications Each time you receive a new package of Nuwiq, you should therefore note the date and batch number (indicated on the package after Lot<\/em> ) and keep this information in a safe place.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any 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, ask your doctor for advice before using this medicine.<\/p>\n\n\n\n Nuwiq does not affect the ability to drive or use machines.<\/p>\n\n\n\n This medicine contains 18.4 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per\u00a0vial.\u00a0This corresponds to 0.92% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n Treatment with Nuwiq is started by a doctor who has experience in treating patients with\u00a0hemophilia\u00a0A. Always use this medicine exactly as your doctor or nurse has told you.\u00a0If you are not sure, talk to your doctor or nurse.<\/p>\n\n\n\n Nuwiq is usually injected into a vein (\u00a0intravenously\u00a0) by a doctor or nurse experienced in the care of patients with\u00a0hemophilia\u00a0A. You or someone else can also give your Nuwiq as an\u00a0injection, but only after receiving\u00a0adequate\u00a0training.<\/p>\n\n\n\n Your doctor will calculate your\u00a0dose\u00a0of Nuwiq (in international units = IU) depending on your health condition and body weight, and depending on whether it is used as a preventative or as a treatment for bleeding.\u00a0How often you need an\u00a0injection\u00a0depends on how well Nuwiq works for you.\u00a0Usually, the treatment of\u00a0hemophilia\u00a0A is a lifelong treatment.<\/p>\n\n\n\n Prevention of bleeding<\/p>\n\n\n\n The usual dose of Nuwiq is 20 to 40 IU per kg body weight, given every two to three days. In some cases, more frequent injections or higher doses may be needed, especially for younger patients.<\/p>\n\n\n\n Bleeding treatment<\/p>\n\n\n\n Dose one of Nuwiq is calculated depending on your body weight and the levels of factor VIII to be achieved. The desired level of factor VIII depends on the severity and location of the bleeding.<\/p>\n\n\n\n Contact your doctor if you experience that Nuwiq has an insufficient effect.\u00a0Your doctor will perform appropriate laboratory tests to ensure you have adequate levels of\u00a0factor VIII.\u00a0This is especially important if you are having major surgery.<\/p>\n\n\n\n Patients developing factor VIII inhibitors<\/p>\n\n\n\n If your\u00a0factor VIII\u00a0plasma level does not reach the expected level with Nuwiq or if your bleeding is not\u00a0adequately\u00a0controlled, it may be due to the development of\u00a0factor VIII\u00a0inhibitors.\u00a0Your doctor will check this.\u00a0You may need a higher\u00a0dose\u00a0of Nuwiq or another medicine to control your bleeding.\u00a0Do not increase the total\u00a0dose\u00a0of Nuwiq to control your bleeding without consulting your doctor.<\/p>\n\n\n\n Nuwiq is given to children and adolescents in the same way as to adults. Because factor VIII products may need to be given more often to children and adolescents, a central venous catheter (CVK) may need to be applied. A CVK is an external connection that allows access to the bloodstream through a catheter without injection through the skin.<\/p>\n\n\n\n No symptoms of overdose have been reported. If you have been given more Nuwiq than you should, tell your doctor.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0Continue immediately with the next\u00a0dose, and proceed as directed by your doctor.<\/p>\n\n\n\n Do not stop using Nuwiq without consulting your doctor.<\/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 Stop using this medicine and seek medical advice immediately if:<\/strong><\/p>\n\n\n\n Allergic reactions may include skin rash,\u00a0hives,\u00a0urticaria\u00a0(itchy rash), including generalized\u00a0urticaria, swelling of the lips and tongue, shortness of breath, wheezing, chest tightness, vomiting, restlessness, low\u00a0blood pressure,\u00a0and dizziness.\u00a0These symptoms may be early symptoms of anaphylactic\u00a0shock.\u00a0If severe, sudden allergic reactions (anaphylactic) occur (very rare; may affect up to 1 in 10,000 people), the\u00a0injection\u00a0should be stopped immediately and you should contact a doctor immediately.\u00a0Severe symptoms require immediate emergency treatment.<\/p>\n\n\n\n Among children and adolescents not previously treated with factor VIII drugs, it is very common for inhibitory antibodies to develop (see section 2) (occurs in more than 1 in 10 patients).<\/p>\n\n\n\n However, for patients who have previously been treated with factor VIII (treatment for more than 150 days), the risk is less common (occurs in less than 1 in 100 patients). If this happens, your or your child’s medication may stop working properly, and you or your child may experience persistent bleeding. If this happens, consult a doctor immediately.<\/p>\n\n\n\n Common side effects may affect up to 1 in 10 people<\/strong><\/p>\n\n\n\n Hypersensitivity, fever<\/p>\n\n\n\n Tingling or numbness (\u00a0paresthesia\u00a0), headache, dizziness, dizziness,\u00a0dyspnoea,\u00a0dry mouth, back pain,\u00a0inflammation\u00a0at the injection site, pain at the injection site, vague feeling of physical discomfort (feeling sick), bleeding anemia, positive for non-neutralizing\u00a0antibody\u00a0(in previously treated patients).<\/p>\n\n\n\n By reporting\u00a0side effects, you can help increase drug safety information.<\/p>\n\n\n\nWhat you need to know before using Nuwiq<\/h2>\n\n\n\n
Do not use Nuwiq<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
In patients who have risk factors for cardiovascular disease, treatment with FVIII may increase the risk of cardiovascular disease.<\/p>\n\n\n\n
If you need a central venous access device (CVAD), the risk of CVAD-related complications, including local\u00a0infections, the presence of bacteria in the blood, and\u00a0thrombosis\u00a0at the catheter site should be considered.
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It is important to keep a record of Nuwiq’s batch number.<\/p>\n\n\n\nOther medicines and Nuwiq<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nuwiq contains sodium<\/h2>\n\n\n\n
3. How to use Nuwiq<\/h2>\n\n\n\n
Use for children and adolescents<\/h2>\n\n\n\n
If you use more Nuwiq than you should <\/h2>\n\n\n\n
If you forget to use Nuwiq<\/h2>\n\n\n\n
If you stop using Nuwiq<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
Additional side effects in children and adolescents<\/h2>\n\n\n\n
Uncommon side effects may affect up to 1 in 100 people<\/strong><\/p>\n\n\n\n