See section 4. It may harm them, even if their signs of illness are the same as yours. This medicine has been prescribed for you only. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care. Tell any other doctors, nurses, dentists, and pharmacists who treat you that you are 6. It also moved to the PowerPC architecture in version 2.5.1 but was canceled when its port was released immediately. It is used for the management of a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 1,200 mg (4 vials of 30 ml) over a 25 – 45 minute (35 minutes ± 10 minutes) period. Prime also revised the reimbursement equation used with providers to give them a more reasonable margin and us the savings we needed: Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica. SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. Soliris can block the body’s inflammatory response, and its ability to attack and destroy its own eye nerves and spinal cord, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living. See full prescribing information for complete boxed warning . Soliris is also used to treat adults and children patients with a certain type of disease affecting the blood system and kidney called atypical Haemolytic Uremic Syndrome (aHUS). 2. Please note that medical information found News-Medical speaks to Dr. Keiko Ishii about her research efforts during the COVID-19 pandemic and how speaking whilst infected can cause the virus to spread, and why wearing masks is so important. Package leaflet: Information for the user, Soliris 300 mg concentrate for solution for infusion. discuss the risks and benefits for you and your child if you breastfeed whilst on severe muscle aches combined with flu-like symptoms. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection. discontinuing treatment). red blood cell counts (anaemia), tiredness, difficulty in functioning, pain, dark Your doctor will also want to monitor you closely. Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). Soliris is used for the treatment of patients with a disease that affects red blood Symptoms or problems from red blood cell breakdown include: a large drop in your red blood cell count causing anaemia. In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. There have been no reported overdoses of Soliris. However, some side effects may need medical attention. The product was created by the Selexis using its SUREtechnology Platform and will be marketed by Generium, the leading pharma company for orphan indications in Russia. It is not known if SOLIRIS is safe and effective in children with gMG. Soliris increases the risk of harm to the unborn baby; however, your doctor will discuss Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells. Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in … SOLIRIS is a medicine that contains the active substance ECULIZUMAB and is available as Vial. of patients with a disease that affects red blood cells called Paroxysmal Nocturnal by the immune system. Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS). The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml). Soliris is a clear and colorless solution. Your doctor will want to monitor you closely. This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH. Because of the importance of rapidly identifying and treating certain types of infection in patients who receive Soliris, you will be provided a card to carry with you, listing specific trigger symptoms. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Soliris can block the body’s inflammatory response, and its ability to attack and Soliris is also used to treat atypical hemolytic uremic syndrome (aHUS). urine, kidney failure, shortness of breath and blood clots. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). If you forget an appointment to receive Soliris. The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant. Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). being short of breath (especially when exercising), flu-like symptoms such as fever, sore throat, cough and chills looking pale, indigestion or an uncomfortable feeling in the stomach or belching after eating, muscle spasms or aching muscles, muscle tenderness or weakness not caused by exercise, upper respiratory tract infection, cough, throat pain, severe infection (meningococcal infection, fungal infection (Aspergillus), infection Russia has approved for patient use the first biosimilar of Soliris (eculizumab), a monoclonal antibody for the treatment of atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH).. Uraemic Syndrome (aHUS). There are no special precautions needed for the treatment of patients aged from 65 years and over. If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”. Long-term Effects of COVID-19 in Athletes, Hand Hygiene: Washing with Soap vs Using Hand Sanitizer, AACI survey finds many opportunities for cancer center networks to increase patient satisfaction, outcomes, CUNY SPH receives prestigious Harrison C. Spencer Award for Outstanding Community Service, Executive control differences in autism may be the result of a unique approach, Pragmatic recommendations for management of COVID-19 in low- and middle-income countries, Understanding how people use 311 non-emergency issue-reporting system during the pandemic. Your doctor will also want to monitor you closely. It can be used for treating serious kidney disorder called atypical hemolytic uremic syndrome (aHUS). the supervision of your doctor, it is unlikely that you will receive too much. It is important Ensure that your current meningococcal vaccination is up to date. A significant fall in your red blood cell counts (anaemia). If you forget or miss a Soliris infusion, call your doctor immediately. Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS). Have had an allergic reaction to Soliris, or any of the ingredients listed at the For children and adolescents with PNH and aHUS aged less than 18 years: For body weight 30 to <40 kg: initial phase 600 mg weekly for first two weeks, maintenance phase 900 mg at week 3; then 900 mg every 2 weeks. The original leaflet can be viewed using the link above. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. of their red blood cells. SOLIRIS is a prescription medicine called a monoclonal antibody. Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). Haemoglobinuria (PNH). This leaflet provides important information about using Soliris. lining of the brain) and sepsis (infection in the blood), as well as other infections Soliris is used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH) adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS) Soliris is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Remind any doctor, nurse, pharmacist or dentist you visit that you are using Soliris. What should I know while using Soliris? However, children need to be vaccinated against influenza and pneumonia before starting treatment. and its ability to attack and destroy its own eye nerves, brain and spinal cord. 4. Soliris is also used to treat adult patients with a disease of the central nervous After you have received medical advice for any side effects you experience, you can In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 25 – 45 minute (35 minutes ± 10 minutes) period. reaction), bleeding or bruising more easily than normal, fast or irregular heartbeats, also called palpitations. 5. Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening genetic disease that causes the red blood cells to be broken down too quickly. SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. Human translations with examples: soliris, Önnek beadni, c04002 soliris, soliris ekulizumab. Tell your doctor if you have a fever or any type of infection. sure the medicine has the best chance of providing treatment for the condition. From Wikipedia, the free encyclopedia Not to be confused with ocrelizumab. More instructions can be found in Section. This disorder can cause a decrease in red blood cells (anemia). This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. What is Soliris used for? Please report side effects. In this way Soliris improves anaemia, fatigue, and other signs These highlights do not include all the information needed to use SOLIRIS safely and effectively. Soliris is used for the treatment of patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). If you are not sure what the side effects below are, ask your doctor to explain them to you. Do not throw away any medicines via wastewater. Could a diet high in carbohydrates increase your risk of heart disease? Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening genetic disease that causes the red blood cells to be broken down too quickly. Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. Below is a text only representation of the Patient Information Leaflet. All medicines can have side effects. widespread gonorrhoea). SOLIRIS is a prescription medicine called a monoclonal antibody. Soliris treatment may reduce your natural resistance to infections, especially against 3. To email a medicine you must sign up and log in. Solaris is a Unix enterprise OS. Decreased urination (problems with your kidneys). SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6). A significant fall in your platelets (thrombocytopenia). As Soliris is given to you under Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening genetic disease that causes the red … Soliris is used for the treatment Ultomiris (ravulizumab) is expected to be more cost-effective than its predecessor Soliris (eculizumab) as a treatment for atypical hemolytic uremic syndrome (aHUS) in the U.S., a new study indicates.. Continue, Alexion Pharma International Operations Unlimited Company. meningococcal infection, you are not up to date with your meningococcal vaccination, if it is less than 2 weeks after receiving your meningococcal vaccination and you This saved Prime’s plans $281,000 per member annually. Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). For more information, including what to do if you have any side effects, see Section. What is Soliris used for? In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). How to use Soliris destroy blood cells. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body’s systems from attacking and destroying vulnerable blood cells, kidneys, muscles or eye nerves and spinal cord. is not for use in this patient population. Soliris has not been studied in children and adolescent patients with NMOSD. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. as thrombotic microangiopathy or TMA). Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). These are rare, life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. of Soliris. Ultomiris (ravulizumab-cwvz) and Soliris (eculizumab) are monoclonal antibodies used to treat patients with paroxysmal nocturnal hemoglobinuria (PNH). Interrupting or stopping treatment with Soliris may cause your gMG symptoms to come back. If you have any further questions, ask your doctor, pharmacist or nurse. are not taking antibiotics to reduce the risk of infection, During treatment, you may be at risk of developing certain side effects. 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. 2. Name: SOLIRIS Generic Name: ECULIZUMAB Strength: 300 mg single-use vials containing 30 mL of 10 mg/ml. If you are having plasma exchange or plasma infusion you may receive additional doses caused by similar bacteria (e.g. Your doctor will discuss the possible side effects with you and explain the risks. What you need to know before you use Soliris Possible side effects If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine. Remind any doctor, nurse, dentist or pharmacist you visit that you are using Soliris. Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica. How it works. The expiry date refers to the last day of that month. not store it: If you no longer need to use this medicine or it is out of date, take it to any pharmacy That’s a book of business savings of $52.5 million for Soliris. Soliris is also used to treat patients with a condition called atypical Haemolytic PNH patients lack these SOLIRIS is a prescription medicine called a monoclonal antibody. use adequate contraception whilst being treated with Soliris (and up to 5 months after After the fifth week, your doctor will administer 1,200 mg of diluted Soliris every two weeks as a long-term treatment. under Section. Patients with PNH lack naturally occurring protective proteins on the surface of some you understand these risks and how to monitor for them. Drug Type: Eculizumab is a “monoclonal antibody” that binds or attaches to a protein present in the blood. The amount of Soliris that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Under the Soliris REMS, prescribers must enroll in the program. not assessed as part of its registration. What should I know before I start using Soliris, Researchers discover new COVID-19 variants in three South African provinces, Study confirms B.1.1.7 variant of SARS-CoV-2 is more transmissible, Newly-discovered bat coronavirus 94.5% identical to SARS-CoV-2, UK variant of SARS-CoV-2 could be more deadly than previous strains, Data from Israel’s vaccination program suggests Pizer-BioNTech COVID-19 vaccine induces strong host antibody response, Pooling COVID-19 tests to detect future outbreaks, Speaking whilst infected with COVID-19 may cause it to spread. body’s response if you stop therapy. Each infusion will take approximately 25 – 45 minutes in adults, and 1 to 4 Do not use this medicine after the expiry date. Soliris vials in the original package may be removed from refrigerated storage (up SOLIRIS is used to treat: patients-with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Patients with aHUS have an inflammatory condition which affects the blood system and If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor. kidney. or nurse if you have any questions. Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. Data in a limited number of pregnant women treated with Soliris do not indicate that See the. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. This includes any possible side effects not listed in this leaflet. Soliris 300 MG in 30 ML Injection is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH). Treatment with Soliris () leads to significant benefits in people with treatment-resistant generalized myasthenia gravis (gMG), including those with myasthenic crisis and thymoma-associated disease, a real-world study from Japan shows.. See Important Safety Information, including Boxed Warning, and full Prescribing Information. There are also links to other websites about rare diseases and treatments. If you forget or miss your appointment for a Soliris infusion, contact your doctor It is not known if SOLIRIS is safe and effective in children with gMG. This card is named: “Patient Safety Card”. At the end of this period unopened Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable blood and kidney cells. This leaflet was last revised in February 2020. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or For body weight 10 to <20 kg: initial phase 600 mg weekly for the first week, maintenance phase 300 mg at week 2; then 300 mg every 2 weeks. Check with your doctor if you are pregnant or intend to become pregnant. Your doctor may wish to test your body’s response to Soliris or may wish to test your It is not known whether Soliris passes into breast milk; however, your doctor will Patients with PNH lack naturally occurring protective proteins on the surface of some of their red blood cells. By continuing to browse the site you are agreeing to our policy on the use of cookies. to 25°C) for only one single period of up to 3 days. Soliris is also used to treat adult patients with a certain type of disease that predominantly affects the eye nerves and the spinal cord called Neuromyelitis Optica Spectrum Disorder (NMOSD). cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). 2. You can also report side effects directly via the national reporting system listed below. Soliris is a prescription medicine called a monoclonal antibody. This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). SOLIRIS is a prescription medicine called a monoclonal antibody. Soliris is a prescription medicine called a monoclonal antibody. system that mainly affects the eye nerves and the spinal cord called Neuromyelitis Soliris is a prescription medicine called a monoclonal antibody. Talk to your doctor if you are breastfeeding or intend to breastfeed. Some medicines may interfere with Soliris and affect how it works. Contents of the pack and other information, 1. Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon. Soliris is presented as a concentrate for solution for infusion (30 ml in a vial – pack size of 1). Soliris is used to treat adults and children with: • paroxysmal nocturnal haemoglobinuria (PNH); • atypical haemolytic uremic syndrome (aHUS). Soliris vials in the original package may be removed from refrigerated storage (up Soliris is a clear, colourless, solution contained in a 30mL glass vial. SOLIRIS is used to treat: patients-with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). It is written for patients and gives information about taking or using a medicine. Soliris is specifically indicated for patients who remain symptomatic despite treatment with other existing MG therapies. Soliris is used to treat patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening genetic disease that causes the red blood cells to be broken down too quickly. Very common: may affect more than 1 in 10 people: headache. If you experience any of the following symptoms, you should immediately inform your doctor: Treatment for meningococcal infection while travelling. Life-threatening and fatal meningococcal infections have occurre Eculizumab was the first drug approved for each of its uses, and its approval was granted based on small trials. you closely for signs and symptoms of potential NMOSD relapse. These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. To view the changes to a medicine you must sign up and log in. If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated . Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. frequency and dose that varies depending on their weight, Children and adolescents who weigh more than 40kg are treated with the adult dosing. Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing. or search for MHRA Yellow Card in the Google Play or Apple App Store. them are minor and temporary. Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). have any further questions about side effects. You should not use this medication if you have bacterial meningitis or if you have not been vaccinated against meningitis. Children and adolescents with PNH or aHUS and who are under 40 kg weight require a lower dose based on how much they weigh. It can handle a large workload and still keep operating smoothly across databases, systems and applications. You may need to read it again. See Important Safety Information, including Boxed Warning, and full Prescribing Information. When suggestions are available use up and down arrows to review and ENTER to select. Ask your doctor infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), skin tumor (melanoma), bone marrow disorder. certain bacteria that can cause meningococcal meningitis (severe infection of the Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). In the SOLID-C19 study, Soliris (Eculizumab) will be used to modulate the activity of the distal complement preventing the formation of the membrane attack complex. By modulating this portion of the immune response, mortality can be halted while the patient has time to recover from the virus with supportive medical care. Soliris binds to proteins in the blood that can destroy red blood cells in people with genetic conditions that affect the natural defenses of red blood cells. Pregnancy and breastfeeding. Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or Read all of this leaflet carefully before you start using this medicine because it contains important information for you. The data suggest that Soliris may be suitable for gMG patients with these features and who also check predefined eligibility criteria. What should I know before I use Soliris? Keep this leaflet. Solaris was developed by Sun Microsystems and has been owned by the Oracle Corporation since its take-over of Sun in early 2010. This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. Elderly patients need to be closely monitored when treated with Soliris. end of this leaflet, or any other proteins of mouse origin. Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, take any medicines for any other condition. SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. supermarket or health food shop. This site complies with the HONcode standard for trustworthy health information: verify here. Work has been done to support Itanium hardware, but it has never been released. For body weight 20 to <30 kg: initial phase 600 mg weekly for the first two weeks, maintenance phase 600 mg at week 3; then 600 mg every 2 weeks. The study, “ A US cost-minimization model comparing ravulizumab versus eculizumab for the treatment of atypical hemolytic uremic syndrome,” was published in the Journal of Medical Economics. Continue typing to refine. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). After the fifth week, your doctor will administer 900 mg of diluted Soliris every two weeks as a long-term treatment. Keep this medicine out of the sight and reach of children. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. 2. The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause: If you have any of these symptoms, contact your doctor. This disorder can cause a decrease in red blood cells ( anemia ). 1,2 SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS) Soliris is a medicine that affects your immune system. What is Eculizumab (Soliris) used for? Dosing information for Soliris® (eculizumab). SOLIRIS is used to treat: adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive It is not known if SOLIRIS is safe and effective in children with gMG. This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. Solaris is the computer operating system that Sun Microsystems provides for its family of Scalable Processor Architecture-based processors as well as for Intel-based processors. Soliris can be used on children under doctor’s supervision. This medicine is only available with a doctor's prescription.
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