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Novothirteen® 2500 IU Catridecacog (Rys) Recombinant Coagulation Factor XIII

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Novothirteen® 2500 IU Catridecacog (Rys) Recombinant Coagulation Factor XIII NovoThirteen® 2500 IU catridecacog (rys) Recombinant coagulation factor XIII Consumer Medicine Information What is in this leaflet missing the factor XIII (A-subunit) (thrombosis), as NovoThirteen protein. NovoThirteen® replaces may increase the severity of a What NovoThirteen® is used for the missing Factor XIII and helps to pre-existing blood clot; Before you use NovoThirteen® stabilise the initial blood clot by • are allergic to rFXIII, yeast producing a mesh around the clot. Using NovoThirteen® protein or to any of the Ask your doctor or healthcare ingredients in NovoThirteen®; While you are using professional if you have any NovoThirteen® • are using other blood clotting questions about why factors. It is not recommended Side effects NovoThirteen® has been given to to use NovoThirteen® and Storage you. recombinant factor VIIa Your doctor may have prescribed it Product Description (another blood clotting factor) for another reason. NovoThirteen® User Instructions together; • are pregnant or trying to become This leaflet answers some common pregnant; questions about NovoThirteen®. It does not contain all the available Before you use • are breast-feeding or planning to information. It does not take the NovoThirteen® breast-feed. place of talking to your doctor or Tell your doctor if you have or have had any medical conditions, healthcare professional. When NovoThirteen® should especially the following: All medicines have risks and not be used benefits. Your doctor has weighed • blood clots (thrombosis); You should not use or be treated the risks of you using • liver disease or liver damage with NovoThirteen® if you have an NovoThirteen® against the benefits Contact your doctor immediately: allergy to: they expect it will have for you. • If you experience unexpected • catridecacog or any of the If you have any concerns about bleeding during your treatment ingredients listed at the end of using this medicine, ask your with NovoThirteen®. Your this leaflet doctor or healthcare professional. doctor will prescribe an Keep this leaflet with the (refer to the section “Side effects” alternative treatment to treat the medicine. to look for signs of an allergic bleeding. reaction). You may need to read it again. Antibodies with neutralising effect If you are uncertain as to whether against NovoThirteen® could you have such an allergy, raise decrease the effectiveness of the this concern with your doctor. treatment and thereby result in What NovoThirteen® is Do not use it after the expiry date unexpected spontaneous bleeding used for (‘Expiry’) printed on the carton episodes. Neutralising antibodies and label. have not been seen in clinical trials NovoThirteen® contains the active Do not use NovoThirteen® if the with NovoThirteen®. substance catridecacog, which is packaging is torn, shows signs of Tell your doctor if you plan to identical to human coagulation tampering or does not look quite have surgery. factor XIII, and is produced by right. recombinant technology. FXIII is an If you have not told your doctor/s about any of the above, tell enzyme necessary for blood Before you start to use it him/them before you use clotting. Tell your doctor if you: NovoThirteen®. NovoThirteen® is used to prevent • have, or have ever had, a higher bleeding in patients who are risk of blood clots forming NovoThirteen® 2500 IU Published by MIMS November 2018 1 Taking other medicines NovoThirteen® has been prepared Your doctor may adapt the dose if for injection, it should be used this is deemed necessary. Do not use NovoThirteen® and blood clotting factor concentrates immediately. Discard your vial after The reconstituted NovoThirteen® at the same time. use. should be administered as a slow Tell your doctor before you use If the reconstituted product is not bolus intravenous injection at a rate NovoThirteen® and medicines used immediately it should be used not higher than 2 mL/minute. used to reduce the dissolving of within 3 hours if stored at For more information on how to get blood clots. temperatures below 25°C or within your injection ready, see Tell your doctor if you are taking 24 hours if stored at 2 - 8°C. If it is ‘NovoThirteen® User Instructions’. any other medicines, including left longer, the medicine may no For more information about how to any that you buy without a longer be sterile and the amount of inject NovoThirteen® contact your prescription from your activated rFXIII will increase. pharmacy, supermarket or health Activated rFXIII may increase the doctor food shop. risk of getting a blood clot After you use it (thrombosis). Immediately before you use it Once NovoThirteen® has been • Do not refill NovoThirteen® Make sure that: reconstituted it must not be frozen. vials. • the packaging is not damaged or If the reconstituted product does • Healthcare professionals, torn; freeze it must not be used and must relatives and other carers should follow general precautionary • the protective tamper-proof be discarded. measures for removal and plastic caps are in place, and are disposal of needles to eliminate not loose or missing; When and how much to use the risk of needle stick injury. • the NovoThirteen® powder in NovoThirteen® is given as an the vial is white and the solvent injection into a vein. Your dose will How long to use it is a clear colourless solution; depend on your body weight. The • the vials are not damaged usual dose is 35 IU for each Do not stop using NovoThirteen® kilogram of body weight. The without consulting your doctor. injections are given once a month Your doctor will explain what (every 28 +/- 2 days). might happen if you stop treatment and discuss other options with you. Using NovoThirteen® Based on the concentration of NovoThirteen® solution, the dose If you use too much How to use NovoThirteen® volume to be injected (in millilitres) (overdose) can be calculated from this formula: Start of treatment with If you are given or if you give NovoThirteen® should be Dose volume in millilitres = 0.042 x yourself too much NovoThirteen® supervised by a doctor with your body weight in kg. you should contact your doctor experience in rare bleeding Use in small children immediately. Your doctor will take conditions. Following treatment If you need to give NovoThirteen® appropriate action. cycles should also be supervised by to a child weighing less than 24 kg If you have any concerns about a doctor for a period of time. you should dilute the reconstituted taking this medicine, ask your Always use this medicine exactly as NovoThirteen® with 6.0 mL of doctor or haemophilia nurse. your doctor has told you. Check sodium chloride 0.9% solution for with your doctor or healthcare injection. This makes the dosing of If you forget to use it professional if you are not sure. small children easier. For more NovoThirteen® is given as an information see section ‘Dilution of You should contact your doctor injection into a vein. Solvent must the reconstituted product with who will take the appropriate be added (reconstitution) to the vial sodium chloride 0.9% solution for action. Do not take a double dose to of NovoThirteen® powder before injection’ in the NovoThirteen® make up for a forgotten dose. the solution is injected. The solution user instruction. should be clear and colourless. The dose volume for the use in Reconstitution and injection: small children can be calculated Please refer to the user instructions. from this formula NovoThirteen® is for single use in Dose volume in mL = 0.117 x body one person only. Once weight in kilograms. NovoThirteen® 2500 IU Published by MIMS November 2018 2 While you are using • local reaction around the Storage NovoThirteen® injection site such as redness, itchiness, tenderness, pain or NovoThirteen® must be stored at 2- discomfort 8ºC. It should not be frozen. If the Things you must do • pain in the legs or arms product freezes it should be You and your doctor should • frequent infections, such as discarded. NovoThirteen® must monitor your bleeding. Tell your fever, severe chills, sore throat only be used if the package is doctor or nurse if your bleeding or mouth ulcers which may be undamaged and the use by gets worse. symptoms of a lack of white (‘expiry’) date marked on the pack blood cells has not passed. Contact your doctor The above list includes the more Protect from light. immediately: common side effects of your Never use NovoThirteen® after • If you experience unexpected medicine. the expiry date printed on the bleeding during your treatment Contact your doctor immediately, label and carton. with NovoThirteen®. Your or go to the accident and The expiry date refers to the last doctor may prescribe an emergency department at your day of that month. alternative treatment to treat the nearest hospital if you have an Never use NovoThirteen® vials if bleeding. allergic reaction. The signs might the solution is not clear and include: • If you experience unexpected colourless when reconstituted spontaneous bleeding during • sudden signs of allergy, such as with the solvent. treatment with Factor XIII rash, hives or itching, swelling Keep out of the reach of children. containing products. Antibodies of the face, lips, tongue or other against NovoThirteen® could parts of the body decrease the effectiveness of the • pinkish, itchy swellings on the treatment and thereby result in skin Product Description unexpected spontaneous • shortness of breath, wheezing or bleeding episodes. Contact difficulty breathing NovoThirteen® can only be obtained from a hospital or your doctor immediately if • low blood pressure (cold haemophilia treatment centre. bleeding occurs. clammy skin, rapid weak heartbeat) This leaflet does not tell you all that Things you must not do • feeling dizzy and sweating is known about NovoThirteen®. If you have any questions about Do not give NovoThirteen® to These are serious side effects and NovoThirteen®, ask your doctor anyone else, even if they have the you may need urgent medical same condition as you.
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