500 IU and 1000 IU powder and solvent for solution for injection Human
coagulation factor IX<\/p>\n\n\n\n
Nanofix belongs to a group of medicines called coagulation factors and contains coagulation factor IX from human blood. This is a special protein that increases the blood’s ability to coagulate.<\/p>\n\n\n\n
Nanofix is \u200b\u200bused to treat or prevent bleeding in patients with\u00a0hemophilia\u00a0(\u00a0haemophilia\u00a0B).\u00a0This is a disease that causes you to bleed longer than you would normally expect.\u00a0The disease is due to a hereditary deficiency of\u00a0coagulation factor\u00a0IX in the blood.
Nanofix is \u200b\u200bsupplied as a powder and solvent for solution for\u00a0injection\u00a0.\u00a0After reconstitution, the drug is\u00a0administered intravenously\u00a0(injected into a vein).<\/p>\n\n\n\n
Do not use Nanofix<\/p>\n\n\n\n
– if you are allergic to human coagulation factor IX or any of the ingredients of Nanofix (listed in section 6).<\/p>\n\n\n\n
if you have heparin-induced\u00a0thrombocytopenia\u00a0type II, which results in a decrease in the number of\u00a0platelets\u00a0in your blood after\u00a0administration\u00a0of\u00a0heparin.\u00a0Platelets\u00a0are blood cells that help stop the bleeding.\u00a0Heparin\u00a0is a drug used to prevent blood clots.<\/p>\n\n\n\n
Talk to your doctor or pharmacist before using Nanofix.<\/p>\n\n\n\n
hives _<\/p>\n\n\n\n
– skin rash<\/p>\n\n\n\n
– pressure over the chest<\/p>\n\n\n\n
– wheezing<\/p>\n\n\n\n
– low blood pressure<\/p>\n\n\n\n
acute,\u00a0severe\u00a0allergic reaction\u00a0(anaphylactic\u00a0shock, when one or all of the above symptoms develop rapidly or are severe).<\/p>\n\n\n\n
If these symptoms occur, the\u00a0injection\u00a0should be stopped immediately and a doctor consulted.\u00a0In case of anaphylactic\u00a0shock, the doctor will start the recommended treatment as soon as possible.<\/p>\n\n\n\n
– you show signs of fibrinolysis (dissolved blood clot)<\/p>\n\n\n\n
– you have disseminated intravascular coagulation (widespread blood clots in the blood vessels)<\/p>\n\n\n\n
– you have been diagnosed with a liver disease<\/p>\n\n\n\n
– you have known risk factors that affect the cardiovascular condition<\/p>\n\n\n\n
– you have recently undergone an operation<\/p>\n\n\n\n
– if you have an increased risk of clot formation or an increased risk of disseminated intravascular coagulation<\/p>\n\n\n\n
If any of the above conditions apply to you, your doctor will only give you Nanofix if the benefit of treatment outweighs its risks.<\/p>\n\n\n\n
Following repeated treatment with human factor IX preparations, patients should be monitored for the formation of neutralizing antibodies (inhibitors). Levels should be measured in Bethesda (BU) units using the appropriate biological test method.<\/p>\n\n\n\n
Virus security<\/p>\n\n\n\n
When medicines are made from human plasma or blood, certain measures are taken to prevent the transmission of infection to patients. This includes:<\/p>\n\n\n\n
o a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded.<\/p>\n\n\n\n
o Testing of individual donations and plasma pools for signs of virus\/infection.<\/p>\n\n\n\n
o The manufacturers of these products also include steps in the management of blood and\u00a0plasma\u00a0that can inactivate or\u00a0eliminate\u00a0viruses.<\/p>\n\n\n\n
Nevertheless, the risk of transmission of\u00a0infection\u00a0can not be completely ruled out when drugs made from human blood or\u00a0plasma\u00a0are given.\u00a0This also applies to new, hitherto unknown\u00a0viruses\u00a0and other types of\u00a0infection.<\/p>\n\n\n\n
The measures taken are considered effective against enveloped\u00a0viruses, such as\u00a0HIV,\u00a0hepatitis\u00a0B, and\u00a0hepatitis\u00a0C, and the non-enveloped\u00a0virus\u00a0and\u00a0hepatitis\u00a0A. The measures may be of limited value against non-enveloped\u00a0viruses\u00a0such as parvovirus B19.\u00a0Parvovirus B19\u00a0infection\u00a0can be serious in pregnant women ( fetal\u00a0infection\u00a0), and in individuals with weakened immune systems or patients with certain types of\u00a0anemia\u00a0(eg\u00a0sickle cell anemia\u00a0or\u00a0hemolytic anemia\u00a0).<\/p>\n\n\n\n
When you receive Nanofix, it is recommended that the product name and batch number be registered to enable traceability of the product used.<\/p>\n\n\n\n
Children<\/strong><\/p>\n\n\n\n If Nanofix is \u200b\u200bgiven to neonates, signs of disseminated intravascular coagulation should be closely monitored.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n There is no experience with the use of factor IX during pregnancy or breastfeeding.\u00a0Factor IX should therefore only be used during pregnancy and lactation if necessary.<\/p>\n\n\n\n Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n Nanofix does not affect the ability to operate and use machines.<\/p>\n\n\n\n This medicine contains up to 69 mg of sodium (the main component of table salt) in a vial of Nanofix 500 IU, equivalent to 3.45% of the maximum recommended sodium intake for an adult.<\/p>\n\n\n\n and up to 138 mg sodium in a Vial Nanofix 1000 IU equivalent to 6.9% of the maximum recommended sodium intake for an adult. You should take this into account if you have been prescribed a low-sodium diet.<\/p>\n\n\n\n Always take Nanofix exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Nanofix is \u200b\u200bgiven\u00a0intravenously\u00a0(injected into a vein) after reconstitution with the supplied\u00a0solution for injection.<\/p>\n\n\n\n Use only the infusion aids provided.\u00a0The use of other injection\/infusion aids may increase the risk and lead to unsuccessful treatment.<\/p>\n\n\n\n Treatment should be initiated under the supervision of a physician well versed in the treatment of\u00a0hemophilia.\u00a0How much Nanofix you should take and how long a\u00a0substitution treatment\u00a0should last depends on the severity of your factor IX deficiency.\u00a0It also depends on where it is bleeding and how severe the bleeding is and your clinical condition.<\/p>\n\n\n\n Calculation of the dose:<\/strong><\/p>\n\n\n\n Your doctor will tell you how often and how much Nanofix to inject.<\/p>\n\n\n\n Factor IX\u00a0dose\u00a0is expressed in international units (IU).\u00a0Factor IX activity in\u00a0plasma\u00a0refers to the amount of factor IX in\u00a0plasma.\u00a0It is expressed either as a percentage (compared to normal human plasma) or as international units (compared to an international standard for factor IX in\u00a0plasma\u00a0).<\/p>\n\n\n\n An international unit (IU) of factor IX activity corresponds to the amount of factor IX in one milliliter of normal human blood plasma. Calculation of the required factor IX dose is based on observations showing that 1 IU factor IX per kg body weight increases plasma factor IX activity by 1%. To calculate the dose you need, the factor IX activity in your blood plasma is measured. It shows how much the activity needs to be increased.<\/p>\n\n\n\n The required dose is calculated according to the following formula:<\/p>\n\n\n\n Units required = body weight (kg) x desired increase of factor IX (%) (IU \/ dl) x 0.8<\/strong><\/p>\n\n\n\n The size of the dose and how often it should be given depends on how you respond to the medicine and is determined by your doctor. Coagulation factor IX rarely needs to be given more than once a day.<\/p>\n\n\n\n Because your response to factor IX may vary, the dose and how often it is given should be based on measuring your factor IX levels during treatment.\u00a0Especially during surgeries, the doctor uses blood tests (the activity of factor IX in\u00a0plasma\u00a0) for close monitoring of\u00a0substitution treatment.<\/p>\n\n\n\n Prevention of bleeding:<\/strong><\/p>\n\n\n\n If you have severe\u00a0hemophilia\u00a0B, inject 20-40 IU factor IX per kg body weight.\u00a0For long-term prophylaxis, inject this\u00a0dose\u00a0twice a week.\u00a0Dose\u00a0one should be adjusted according to your response to treatment.\u00a0In some cases, especially in younger patients, shorter dosing intervals and higher\u00a0doses\u00a0may be necessary.<\/p>\n\n\n\n Use for children:<\/strong><\/p>\n\n\n\n In a study in children under 6 years of age, the dose per treatment day was on average 40 IU \/ kg body weight.<\/p>\n\n\n\n If bleeding cannot be stopped due to inhibitors<\/strong> :<\/p>\n\n\n\n Tell your doctor if expected factor IX activity is not achieved after\u00a0injection, or if the bleeding does not stop after the correct\u00a0dose.\u00a0Your doctor will examine your blood plasma to see if you have developed inhibitors (\u00a0antibodies\u00a0) against the factor IX\u00a0protein.\u00a0These inhibitors may reduce factor IX activity.\u00a0In that case, it may be necessary to choose another treatment.\u00a0Your doctor will discuss this with you and, if necessary, recommend further treatment.<\/p>\n\n\n\n If you take more Nanofix than you should<\/strong><\/p>\n\n\n\n No overdose symptoms have been reported for human coagulation factor IX. However, the recommended dose should not be exceeded.<\/p>\n\n\n\n For <\/strong>instructions for treatment at home, see the box with injection aids.<\/strong><\/p>\n\n\n\n Like all medicines, Nanofix can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n In some cases, these allergic reactions can lead to a serious reaction called\u00a0anaphylaxis, which can be associated with\u00a0shock.\u00a0These reactions occur mainly in connection with the formation of factor IX inhibitors.\u00a0If you have any of the symptoms mentioned above, consult your doctor.<\/p>\n\n\n\n \u2022 If you have\u00a0hemophilia\u00a0B, you may develop neutralizing\u00a0antibodies\u00a0(inhibitors) to factor IX.\u00a0These inhibitors can prevent the drug from working properly.\u00a0This condition is called the\u00a0immune response.\u00a0Your doctor will discuss this with you and, if necessary, recommend further treatment.<\/p>\n\n\n\n In a study of 25 children with\u00a0hemophilia\u00a0B, six of whom had not been treated before, no inhibitors were found.\u00a0The tolerability of the injections was considered to be “very good” or “good”.<\/p>\n\n\n\n \u2022 Some patients with\u00a0hemophilia\u00a0B who had factor IX inhibitors and who were treated with immune response therapy and who had an\u00a0allergic reaction\u00a0developed\u00a0nephrotic syndrome\u00a0(a severe kidney disease).<\/p>\n\n\n\n Fever may occur in rare cases.<\/p>\n\n\n\n \u2022 Factor IX products with low purity can in rare cases cause clot formation in a blood vessel. This can lead to any of the following complications:<\/p>\n\n\n\n These side effects are more common if you use factor IX products with low purity, and they only occur rarely if you use high-purity products, such as Nanofix.<\/p>\n\n\n\n \u2022 The product contains\u00a0heparin, which may cause a sudden decrease in\u00a0platelet counts\u00a0below 100,000 \/ microliters or below 50% of the original number.\u00a0This allergic reaction is called “heparin-induced\u00a0thrombocytopenia\u00a0type II”.\u00a0In rare cases, this reduction in\u00a0platelet count\u00a0may occur 6-14 days after the start of treatment in patients who have not previously been hypersensitive to\u00a0heparin.\u00a0In patients with previous heparin hypersensitivity, the change may develop within a few hours after starting treatment.<\/p>\n\n\n\n This severe decrease in the number of blood cells may be associated with or result in:<\/p>\n\n\n\n If you notice these allergic reactions, stop using Nanofix immediately and do not continue to use\u00a0heparin-containing<\/strong>\u00a0medicines .\u00a0Due to this rare effect on platelets, your doctor should monitor your\u00a0platelet count, especially at the beginning of treatment.<\/p>\n\n\n\n For information on virus security, see section 2.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not store above 25 \u00b0 C.<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store the vials in the outer carton. Sensitive to light.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton (month\/year).\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n The reconstituted product should be used immediately, or at least within 8 hours with storage at room temperature (25 \u00b0 C).<\/p>\n\n\n\n Use dissolved Nanofix only once. Do not use this medicine if the solution is cloudy or if the powder has not completely dissolved.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n The active substance<\/strong> is human coagulation factor IX.<\/p>\n\n\n\n The other ingredients<\/strong>\u00a0are\u00a0heparin, sodium chloride, sodium citrate, arginine hydrochloride, and lysine hydrochloride.<\/p>\n\n\n\n Nanofix is \u200b\u200bavailable in two pack sizes with the following strength:<\/p>\n\n\n\n Nanofix is \u200b\u200bmade from human blood plasma.<\/p>\n\n\n\n The potency (IU) is determined by a one-step coagulation test according to the European Pharmacopoeia compared with the World Health Organization (WHO) international standard.\u00a0The specific activity of Nanofix is \u200b\u200bapproximately 100 IU \/ mg\u00a0protein.<\/p>\n\n\n\n Description of packaging:<\/strong><\/p>\n\n\n\n Nanofix is \u200b\u200bsupplied as a combination package, consisting of two cartons held together with plastic film:<\/p>\n\n\n\n A carton contains a vial of powder for solution for injection and a package leaflet.<\/p>\n\n\n\n The second carton contains a vial of solvent (water for injections):<\/p>\n\n\n\n 5 ml for Nanofix 500 IU and 10 ml for Nanofix 1000 IU.<\/p>\n\n\n\n The package also contains the following aids:<\/p>\n\n\n\n Octapharma AB<\/p>\n\n\n\n 112 75 Stockholm<\/p>\n\n\n\n Tel: 08-566 43000<\/p>\n\n\n\n Customer contact: 020-311020<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Octapharma Pharmazeutika Produktionsges.mbH<\/p>\n\n\n\n Oberlaaer Strasse 235<\/p>\n\n\n\n A-1100 Vienna<\/p>\n\n\n\n Austria<\/p>\n\n\n\n Octapharma SAS<\/p>\n\n\n\n 70-72 Rue du Mar\u00e9chal Foch<\/p>\n\n\n\n 67380 Lingolsheim<\/p>\n\n\n\n France<\/p>\n\n\n\n For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:<\/p>\n\n\n\n Octapharma AB<\/p>\n\n\n\n 112 75 Stockholm<\/p>\n\n\n\n Tel: 08-566 43000<\/p>\n\n\n\n Customer contact: 020-311020<\/p>\n","protected":false},"excerpt":{"rendered":" Nanofix belongs to a group of medicines called coagulation factors and contains coagulation factor IX from human blood. This is a special protein that increases the blood’s ability to coagulate.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,15581],"tags":[13028,13025,18333,13027,13026],"class_list":["post-18587","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-coagulation-factor-ix","tag-coagulation-factor-ix","tag-coagulation-factor-ix-side-effects","tag-what-coagulation-factor-ix-is-used-for","tag-what-is-coagulation-factor-ix"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=18587"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18587\/revisions"}],"predecessor-version":[{"id":18638,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18587\/revisions\/18638"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18587"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18587"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other medicines and Nanofix<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nanofix contains sodium<\/h2>\n\n\n\n
How to use Nanofix<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Nanofix<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder<\/h2>\n\n\n\n