500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection nonakog
beta pegol<\/p>\n\n\n\n
What Refixia is<\/strong><\/p>\n\n\n\n Refixia contains the active substance nonakog beta pegol. It is a long-acting version of factor IX. Factor IX is a protein found naturally in the blood that helps stop bleeding.<\/p>\n\n\n\n What Refixia is used for<\/strong><\/p>\n\n\n\n Refixia is used to treat and prevent bleeding in patients 12 years of age or older with\u00a0hemophilia\u00a0B (congenital factor IX deficiency).<\/p>\n\n\n\n In patients with\u00a0hemophilia\u00a0B, factor IX is missing or does not work properly.\u00a0Refixia replaces the factor IX that is malfunctioning or missing and helps the blood to form a\u00a0clot\u00a0(clotted blood) where it bleeds.<\/p>\n\n\n\n If you are not sure if any of the above applies to you, talk to your doctor before using this medicine.<\/p>\n\n\n\n Traceability<\/strong><\/p>\n\n\n\n You must keep track of the Lot number on your Refixia.\u00a0Each time you receive a new package with Refixia, make a note of the date and Lot number (which is on the package after Lot) and keep this information in a safe place.<\/p>\n\n\n\n Allergic reactions and development of inhibitors<\/strong><\/p>\n\n\n\n There is a risk, although it is rare, that you will have a sudden and severe\u00a0allergic reaction\u00a0(eg\u00a0anaphylactic reaction\u00a0) to Refixia.\u00a0Discontinue\u00a0injection\u00a0and contact your doctor or emergency department immediately if you show signs of an\u00a0allergic reaction\u00a0such as skin rash,\u00a0hives,\u00a0itching\u00a0over large areas of skin, red and\/or swollen lips, tongue, face, or hands, difficulty swallowing or breathing, shortness of breath, wheezing, tightness in the chest, pale and cold skin, palpitations and\/or dizziness.<\/p>\n\n\n\n Your doctor may need to treat these reactions immediately. Your doctor may also take a blood test to check if you have developed factor IX inhibitors (neutralizing antibodies ) against your medicine, as inhibitors may develop along with allergic reactions. If you have such inhibitors, you may have a higher risk of sudden and severe allergic reactions (eg anaphylactic reaction ) during future factor IX treatments.<\/p>\n\n\n\n Due to the risk of allergic reactions with factor IX, the first treatment with Refixia should be given in a clinic or the presence of healthcare professionals with access to appropriate medical treatment for allergic reactions if needed.<\/p>\n\n\n\n Contact your doctor immediately if your bleeding does not stop as expected or if you need to significantly increase the amount of Refixia you need to stop bleeding. Your doctor will take a blood test to check if you have developed inhibitors (neutralizing antibodies ) against Refixia. The risk of developing inhibitors is highest in people who have not previously been treated with factor IX drugs, especially young children.<\/p>\n\n\n\n Blood clots<\/strong><\/p>\n\n\n\n Tell your doctor if any of the following apply to you, as there is an increased risk of blood clots during treatment with Refixia:<\/p>\n\n\n\n Kidney disease ( nephrotic syndrome )<\/strong><\/p>\n\n\n\n There is a risk, although rare, of developing a specific kidney disease called “nephrotic syndrome” after high\u00a0doses\u00a0of factor IX in patients with\u00a0hemophilia\u00a0B with factor IX inhibitors and allergic reactions in the history of the disease.<\/p>\n\n\n\n Catheter-related problems<\/strong><\/p>\n\n\n\n If you have aid for central\u00a0intravenous administration,\u00a0infections\u00a0or blood clots may occur\u00a0where the catheter is located.<\/p>\n\n\n\n Tell your doctor 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 Refixia.<\/p>\n\n\n\n Refixia does not affect your ability to drive or use machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0vial, ie essentially ‘sodium-free’.\u00a0it is next to “sodium-free”.<\/p>\n\n\n\n Treatment with Refixia is started by a doctor who has experience in treating patients with\u00a0hemophilia\u00a0B. Always use this medicine exactly as your doctor has told you.\u00a0Ask your doctor if you are not sure how to use Refixia.<\/p>\n\n\n\n Your doctor will calculate the correct dose for you. Dose one depends on your weight and what the medicine is used for.<\/p>\n\n\n\n Prevention of bleeding<\/strong><\/p>\n\n\n\n The usual dose of Refixia is 40 International Units (IU) per kg body weight. It is given as an injection every week. Your doctor may choose a different dose or how often the injections should be given based on your needs.<\/p>\n\n\n\n Treatment of bleeding<\/strong><\/p>\n\n\n\n The usual\u00a0dose\u00a0of Refixia is 40 International IU per kg body weight.\u00a0Depending on where the bleeding is and the severity of the bleeding, you may need a higher\u00a0dose\u00a0(80 IU per kg) or extra\u00a0injections.\u00a0Talk to your doctor about what\u00a0dose\u00a0and how many\u00a0injections\u00a0you need.<\/p>\n\n\n\n Use for children and adolescents<\/strong><\/p>\n\n\n\n Refixia should only be used in adolescents (12 years of age or older). Dose one for adolescents is also calculated based on body weight and is the same dose as for adults.<\/p>\n\n\n\n How Refixia is given<\/strong><\/p>\n\n\n\n Refixia is available as a powder and diluent that is mixed into a solution ( preparation ) and given as an injection into a vein. See “Refixia Instructions for Use” for more information.<\/p>\n\n\n\n If you use more Refixia than you should<\/strong><\/p>\n\n\n\n If you have used too much Refixia, contact your doctor.<\/p>\n\n\n\n If you need to significantly increase the amount of Refixia you need to stop bleeding, contact your doctor immediately. For more information, see section 2 “Allergic reactions and development of inhibitors”.<\/p>\n\n\n\n If you forget to use Refixia<\/strong><\/p>\n\n\n\n If you miss a\u00a0dose, inject the missed\u00a0dose\u00a0as soon as you remember.\u00a0Do not inject a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0Consult a doctor if you are unsure.<\/p>\n\n\n\n If you stop using Refixia<\/strong><\/p>\n\n\n\n If you stop using Refixia, it is possible that you are no longer protected against bleeding or that ongoing bleeding does not stop.\u00a0Do not stop using Refixia without talking to your doctor first.<\/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 Allergic reactions may occur with this medicine.<\/p>\n\n\n\n If sudden and severe allergic reactions (eg anaphylactic reactions) occur,\u00a0the injection\u00a0must be stopped immediately.\u00a0You must contact a doctor or an emergency department immediately if you experience an early symptom of a severe\u00a0allergic reaction\u00a0(\u00a0anaphylactic reaction\u00a0), such as:<\/p>\n\n\n\n The following side effects have been observed with Refixia:<\/strong><\/p>\n\n\n\n Common side effects (<\/strong> may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon side effects (<\/strong> may affect up to 1 in 100 people)<\/p>\n\n\n\n Has been reported<\/strong>\u00a0(occurs in an unknown number of users)<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use Refixia before the expiry date which is stated after \u201cEXP\u201d on the carton and the label of the vial and pre-filled syringe.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C-8 \u00b0 C). Do not freeze. Store in the original package. Sensitive to light.<\/p>\n\n\n\n Refixia can be removed from the refrigerator for a period of up to 6 months and stored at room temperature (maximum 30 \u00b0 C). Write down the date on the box when Refixia is taken out of the refrigerator and placed at room temperature. The new expiry date should never exceed the original expiry date which is stated on the outer carton. If the medicine has not been used before the new expiry date, it must be discarded. After storage at room temperature, the medicine must not be put back in the refrigerator.<\/p>\n\n\n\n Use\u00a0injection\u00a0one immediately after you have made the ordering solution (berdningen).\u00a0If it can not be used immediately, use it within 24 hours if stored in a refrigerator at 2 \u00b0 C-8 \u00b0 C or within 4 hours if stored outside the refrigerator at a temperature of up to 30 \u00b0 C.<\/p>\n\n\n\n The powder in the vial is white to off-white. Do not use the powder if the color has changed.<\/p>\n\n\n\n The prepared solution should be clear and colorless. Do not use the reconstituted solution if you see particles in the solution or if the solution is discolored.<\/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 Novo Nordisk A \/ S<\/p>\n\n\n\n Novo All\u00e9<\/p>\n\n\n\n DK-2880 Bagsv\u00e6rd, Denmark<\/p>\n","protected":false},"excerpt":{"rendered":" Refixia contains the active substance nonakog beta pegol. It is a long-acting version of factor IX. Factor IX is a protein found naturally in the blood that helps stop bleeding.<\/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":[2200,18529],"tags":[22519,22524,22515,22518,22520,22523,22516,22521,22517,22522],"class_list":["post-21799","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-nonakog-beta-pegol","tag-benefits-of-refixia","tag-nonakog-beta-pegol","tag-nonakog-beta-pegol-side-effects","tag-refixia","tag-refixia-side-effects","tag-what-is-nonakog-beta-pegol","tag-what-is-refixia","tag-what-nonakog-beta-pegol-is-used-for","tag-what-refixia-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21799","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=21799"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21799\/revisions"}],"predecessor-version":[{"id":21825,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21799\/revisions\/21825"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Refixia<\/h2>\n\n\n\n
Do not use Refixia<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Refixia<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Refixia contains sodium<\/h2>\n\n\n\n
How to use Refixia<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Refixia<\/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 the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n