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ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Kobayashi RH, Gupta S, Melamed I, et al. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception. Call your doctor right away if you have any new signs or symptoms of infection. 3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB111EZ, UK. I. Ask your doctor if you are not sure if you need to be revaccinated. Package leaflet: Information for the user. Continue, Alexion Pharma International Operations Unlimited Company. â¼This medicine is subject to additional monitoring. Use aseptic technique to prepare ULTOMIRIS as follows: 1. Decreased urination (problems with your kidneys). Ultomiris can block the bodyâs inflammatory response, and its ability to attack and destroy its own vulnerable blood vessels and so control symptoms of the disease including injury to the kidneys. Therefore, effective contraception during treatment and up to 8 months after treatment should be used in women who are able to get pregnant. Your dose of Ultomiris will be calculated by your doctor, based on your body weight, as shown in Table 1. Find support and connect with the atypical-HUS community. The Medical Letter On Drugs and Therapeutics, Eculizumab (Soliris) for Paroxysmal Nocturnal Hemoglobinuria.medicalletter.org, Vol. If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice. Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. HCPs who prescribe ULTOMIRIS must be specifically certified. Eligible patients may pay as little as $0 in out-of-pocket costs relating to medication and infusions. You may report side effects to FDA at 1-800-FDA-1088. Hematology. This will allow quick identification of new safety information. For individuals with body weight greater than 100kg the loading dose is 3000mg. The maintenance dose is 2100mg, starting 2 weeks after loading dose administration. Ultomiris is used to treat adult patients with a disease called paroxysmal nocturnal haemoglobinuria (PNH), including patients untreated with complement inhibitor and patients who have received eculizumab for at least the past 6 months. You should also be aware that vaccination may not always prevent this type of infection. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. See the end of section 4 for how to report side effects. Hemoglobin is the iron-rich protein that gives blood its red color. Ultomiris ™ was approved by the FDA in 2019 for the treatment of atypical hemolytic uremic syndrome (aHUS) in pediatric patients over one month of age and adult patients. Start typing to retrieve search suggestions. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. ULTOMIRIS (ravulizumab-cwvz) injection 10 mg/mL is translucent, slight whitish color solution supplied in single-dose vials as: • 300 mg/30 mL (10 mg/mL) carton containing one vial: NDC 25682-022-01 Store ULTOMIRIS vials refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light. Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH). Contents of the pack and other information. or search for MHRA Yellow Card in the Google Play or Apple App Store. For further information call emc accessibility on 0800 198 5000. More time between infusions means…I get to actually be home more for homeschooling my 12-year-old. When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain. Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks for patient above 20 kg and every 4 weeks for patient less than 20 kg. The maintenance dose is 3000mg, starting 2 weeks after loading dose administration. Ask your pharmacist how to throw away medicines you no longer use. Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial â pack size of 1). For individuals with body weight 40 to <60kg the loading dose is 2400mg. Below is a text only representation of the Patient Information Leaflet. 6. Management of paroxysmal nocturnal hemoglobulinuria in the era of complement inhibitory therapy. Accessed October 2020. Cutaquig ® [package insert]. For individuals with body weight 20 to <30kg the loading dose is 900mg. If you are not sure what the side effects below are, ask your doctor to explain them to you. Get complimentary, personalized support from a dedicated team with expertise in health insurance, advanced training in atypical-HUS, and information about atypical-HUS community resources. Figuring out how to manage atypical-HUS can be difficult to navigate. 2019;10(40):1-12. You can help by reporting any side effects you may get. • Lee JW, Sicre de Fontbrune F, Wong LL, et al. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. Clinical efficacy, safety and tolerability of a new subcutaneous immunoglobulin 16.5% (Octanorm [Cutaquig ®]) in the treatment of patients with primary immunodeficiencies. The effects of the medicine on an unborn child are not known. When suggestions are available use up and down arrows to review and ENTER to select. Your first dose is called the loading dose. Ultomiris, a long-acting complement inhibitor, works by specifically binding to the complement protein C5, inhibiting its cleavage to C5a and C5b, thereby preventing the … If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening … Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. With ULTOMIRIS, you can experience the freedom of up to 8 weeks between infusionsa, with the comfort of established safety. Each vial of solution contains 300 mg of ravulizumab. Borowitz MJ, Craig FE, DiGiuseppe JA, Illingworth AJ, Rosse W, Sutherland DR, Wittwer CT, Richards SJ. Table 1: Ultomiris weight-based dosing regimen. Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). If you receive more Ultomiris than you should. It is written for patients and gives information about taking or using a medicine. A significant fall in your red blood cell counts (anaemia). 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SOLIRIS safely and effectively. How to store Ultomiris References 1. Now FDA approved 100 mg/mL formulation: get the details, IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING. In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots. US/ULT-a/0178. An increase in your serum creatinine level (problems with your kidneys), Abdominal pain, vomiting, stomach discomfort after meals (dyspepsia), Back pain, joint pain (arthralgia), muscle pain (myalgia) and muscle spasms, Influenza like illness, feeling tired (asthenia). For individuals with body weight 10 to <20kg the loading dose is 600mg. Under the ULTOMIRIS REMS, prescribers must enroll in the program (5.1). FIASP® (insulin aspart injection) 100 U/mL 2 cemia usually reflects the time-action profile of the administered insulin formulation. • Parker CJ. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of … ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. The active substance is ravulizumab. References 1. ULTOMIRIS (ravulizumab) POLICY . Be the first to get updates about ULTOMIRIS and special patient-focused resources, including webinars featuring leading atypical-HUS experts. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEGSEDI® safely and effectively. In patients with aHUS, their kidneys and blood vessels, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning. The expiry date refers to the last day of that month. This medicine contains sodium (see section 2 âUltomiris contains sodiumâ). To bookmark a medicine you must sign up and log in. ULTOMIRIS is the first and only long-acting C5 inhibitor that provides immediate and complete inhibition for 8 weeks. These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis). Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. Confusion or change in how alert you are, An increase in your serum creatinine level (problems with your kidneys), or. Hematology. With Soliris, A future with fewer relapses is possible. Do not pass it on to others. Do not throw away any medicines via wastewater. After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature. This medicine has no or negligible influence on the ability to drive and use machines. Parker CJ. Ensure that your current meningococcal vaccination is up to date. Meningococcal vaccines reduce but do not prevent all meningococcal infections. If you are allergic to ravulizumab or any of the other ingredients of this medicine (listed in section 6). If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. For individuals with body weight 60 to <100kg the loading dose is 2700mg. 1. Keep this medicine out of the sight and reach of children. By continuing to browse the site you are agreeing to our policy on the use of cookies. Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution. This includes any possible side effects not listed in this leaflet. Soliris (eculizumab) [package insert]. aNot used in treating people with STEC-HUS. Copyright © 2020 Alexion Pharmaceuticals, Inc. All rights reserved. Once diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, this medicine contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose. By attaching to and blocking the C5 protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease. What Ultomiris looks like and contents of the pack. Boston, MA; Alexion Pharmaceuticals, Inc; October 2019. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the bodyâs defence system called the âcomplement systemâ. The maintenance dose is 3600mg, starting 2 weeks after loading dose administration. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. What Ultomiris is and what it is used for Ultomiris [package insert]. If you get any side effects, talk to your doctor, pharmacist or nurse. Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke. For individuals with body weight 30 to <40kg the loading dose is 1200mg. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. aTwo weeks after the starting dose, ULTOMIRIS is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. Keep this leaflet. Ultomiris 300 mg/3 mL single-use vials for injection: 25682-0025-xx Ultomiris 300 mg/30 mL single-use vials for injection: 25682-0022-xx Ultomiris 1100 mg/11 mL single-use vials for injection: 25682-0028-xx VII. The original leaflet can be viewed using the link above. Ravulizumab (ALXN1210) vs eculizumab in adult Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. You may need to read it again. 2. 2. Boston, MA; Alexion Pharmaceuticals, Inc; October 2020. The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. Package leaflet: Information for the user, Ultomiris 300 mg/30 mL concentrate for solution for infusion. Alexion Pharmaceuticals; 2009. in the complement cascade that is essential for the formation of the membrane attack complex. Boston, MA: Alexion Pharmaceuticals, Inc.; October 2019. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. The risks of stopping Ultomiris include an increase in the destruction of your red blood cells, which may cause: If you have any of these symptoms, contact your doctor. Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. As with all insulin preparations, the glucose lowering effect time course of FIASP® may vary in different individuals or at different times in the same individual and depends … A significant rise in destruction of your red blood cells. The other ingredients are: sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium chloride, polysorbate 80, water for injections. The maintenance dose is 600mg, starting 2 weeks after loading dose administration. SOLIRIS® (eculizumab) [package insert]. You should take this into consideration if you are on a controlled sodium diet. What you need to know before you use Ultomiris. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. Adverse events should also be reported to Alexion Pharma UK Ltd on [email protected], Freephone (UK): 0800321 3902. See section 4. Ultomiris [package insert]. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. See full prescribing information for 3 . Your doctor will want to monitor you closely for at least 16 weeks. This includes any possible side effects not listed in this leaflet. If you forget an appointment, please contact your doctor immediately for advice and see section below âIf you stop using Ultomirisâ. The text only version may be available in large print, Braille or audio CD. 2. The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. INDICATIONS . These measures will help protect the environment. Your doctor will decide if you need additional vaccination. Ultomiris 300 mg/30 mL concentrate for solution for infusion. Ultomiris 300 mg/3 mL single-use vials for injection: 25682-0025-xx Ultomiris 300 mg/30 mL single-use vials for injection: 25682-0022-xx Ultomiris 1100 mg/11 mL single-use vials for injection: 25682-0028-xx VII. Contents of the pack and other information, 1. 3. ULTOMIRIS is a drug used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).PNH is a rare, life-threatening disease in which the bone marrow does not produce enough blood cells and red blood cells break apart prematurely (called hemolysis). 1. Your doctor will discuss the possible side effects with you and explain the risks. Ultomiris [package insert]. This will allow quick identification of new safety information. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. Tell your doctor about any side effect that bothers you or that does not go away. See full prescribing information for ALDURAZYME. • Ultomiris [package insert]. It may harm them, even if their signs of illness are the same as yours. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. Boston, MA; Alexion Pharmaceuticals, Inc; October 2020. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FEMARA safely and effectively. If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Do If you experience any of the following symptoms, you should immediately inform your doctor: Treatment for meningococcal infection while travelling. 2 DOSAGE AND ADMINISTRATION 2.1 Dosage This medicinal product is subject to additional monitoring. ravulizumab This medicine is subject to additional monitoring. Like all medicines, this medicine can cause side effects, although not everybody gets them. Meningococcal and other Neisseria infections symptoms. Before starting Ultomiris, inform your doctor if you have any infections. ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). You can also report side effects directly via the national reporting system listed below. Possible side effects ULTOMIRIS can cause serious side effects including infusion-related reactions. References 1. 2 We may cover Soliris®** (eculizumab) OR we may cover Ultomiris®** (ravulizumab) when all of the following criteria are met: 1. The maintenance dose is 3300mg, starting 2 weeks after loading dose administration. The infusion will take approximately 2 hours. You can help by reporting any side effects you may get. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a âPatient cardâ to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/sepsis. Certification consists of review of REMS educational materials and enrollment in the ULTOMIRIS REMS program. FDA-Approved Indication Ravulizumab is a complement inhibitor Food and Drug Administration (FDA) ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Do not use this medicine after the expiry date which is stated on the carton after âEXPâ. This website is intended for residents of the United States. Accessed October 2019. Whether you or a child you care for had a recent atypical-HUS diagnosis, or you’ve been part of the atypical-HUS community for years, now could be the right time to WIDEN YOUR WORLD. Front Immunol. Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections. Talk to your doctor before using Ultomiris. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. By reporting side effects, you can help provide more information on the safety of this medicine. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. The product code(s) for this leaflet are: EU/1/19/1371/001, EU/1/19/1371/002, EU/1/19/1371/003. 2. Ultomiris injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults. PNH is a rare genetic disorder in which defective red blood cells break down prematurely and leak hemoglobin into your blood. For more information, ask your doctor or pharmacist. 15. Ravulizumab (ALXN1210) vs eculizumab in adult patients with If you have any further questions, ask your doctor, pharmacist or nurse. 2011; 21-29. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Store in the original package in order to protect from light. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. If you had a meningococcal vaccine in the past, you might need additional vaccination. If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you. Because the medicine blocks the complement system, which is part of the bodyâs defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis. The most serious side effect is meningococcal infection/sepsis. See full prescribing information for ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Ultomiris is given by infusion (drip) into a vein. If you forget an appointment to receive Ultomiris. This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult. PATIENT PACKAGE INSERT *Sections or subsections omitted from the full prescribing information are not listed. To view the changes to a medicine you must sign up and log in. Continue typing to refine. Very common (may affect more than 1 in 10 people): Common (may affect up to 1 in 10 people): Uncommon (may affect up to 1 in 100 people): If you get any side effects, talk to your doctor, pharmacist or nurse. If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed. ULTOMIRIS is a medicine that affects your immune system. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. What you need to know before you use Ultomiris This medicine has been prescribed for you only. Ultomiris [package insert]. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity. The dosing for this If you were previously receiving another medicine for PNH and aHUS called eculizumab, the loading dose should be given 2 weeks after the last eculizumab infusion. Lee JW, Sicre de Fontbrune F, Wong LL, et al. Please see accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. Making sure you have all the tools you need to understand and manage your atypical-HUS can really help during your journey. This will allow quick identification of new safety information. 3. ULTOMIRIS may also increase the risk of other types of serious infections. 2. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS® (eculizumab) Humanized First in Class Anti - C5 Antibody Hinge 3 2 Human IgG 4 Heavy Chain Constant Regions 2 and 3 (Eliminates complement activation) Complementarity Determining Regions 49 (Issue 1270), September 24, 2007. 6. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated. At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated. Interrupting or ending treatment with Ultomiris may cause your aHUS symptoms to come back. responsible for cell lysis. The risks of stopping Ultomiris include an increase in small blood vessel damage, which may cause: If you have any further questions on the use of this medicine, ask your doctor. ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). ULTOMIRIS requires dilution to a final concentration of 5 mg/mL. A significant fall in your platelets (thrombocytopenia). It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. What are the possible side effects of ULTOMIRIS? The maintenance dose is 2700mg, starting 2 weeks after loading dose administration. To email a medicine you must sign up and log in. Boston, MA: Alexion Pharmaceuticals, Inc.; December 2018. Before beginning Ultomiris ™, a baseline serum creatine, LDH, and platelet count are necessary for diagnosis and monitoring throughout therapy. 5. Ultomiris is also used to treat patients 10 kg and over with a disease affecting the blood system and kidney called atypical haemolytic uremic syndrome (aHUS), including patients untreated with complement inhibitor and patients who have received eculizumab for at least 3 months. Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy. If you have not been vaccinated against meningococcal infection. Ultomiris [package insert]. Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment. 2. This leaflet was last revised in November 2020. Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body. See the end of section 4 for how to report side effects. Your doctor will want to monitor you closely. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. This site uses cookies. What Ultomiris is and what it is used for. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light. 4. Ravulizumab-cwvz (Ultomiris™) is a humanized monoclonal antibody with a high affinity for C5, a protein. FULL PRESCRIBING INFORMATION . How to use Ultomiris The number of vials to be diluted is determined based on the individual patient’s weight and the prescribed dose [see Dosage and Administration (2.2)]. 4. Your doctor will discuss the possible side effects with you and explain the risks. If your child is less than 18 years, your doctor will administer a vaccine (if not yet done) against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group. You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Lachen, Switzerland: Octapharma AG; 2019. PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney … Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed.
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