what is soliris used for

However, children need to be vaccinated against influenza and pneumonia before starting treatment. It is not known whether Soliris passes into breast milk; however, your doctor will 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. Common Brand(s): Soliris This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). 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. Your doctor will also want to monitor you closely. What you need to know before you use Soliris 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 medicine is also used to treat a serious kidney disorder called atypical hemolytic uremic syndrome (aHUS). nurse. It can handle a large workload and still keep operating smoothly across databases, systems and applications. Eculizumab injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). Soliris is presented as a concentrate for solution for infusion (30 ml in a vial – pack size of 1). Sun has historically dominated the large UNIX workstation market. Soliris ® is a drug approved by the FDA to treat patients with aHUS to inhibit complement -mediated TMA. 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. of Soliris. 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. or nurse if you have any questions. Keep appointments with your doctor or clinic. 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. 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. Each infusion will take approximately 25 – 45 minutes in adults, and 1 to 4 What Eculizumab Is Used For: Eculizumab is used … adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). The European Commission approved Soliris as the first treatment for generalized myasthenia gravis in August 2017, followed by the FDA in October of that year, Alexion announced in a press release. infection of the lung (pneumonia), common cold (nasopharyngitis), infection of the urinary system (urinary tract infection), low white blood cell count (leukopenia), reduction in red blood cells which can make the skin pale and cause weakness or breathlessness, dizziness, taste disorders (dysgeusia), high blood pressure, upper respiratory tract infection, cough, throat pain (oropharyngeal pain), bronchitis, cold sores (herpes simplex), diarrhea, vomiting, nausea, abdominal pain, rash, hair loss (alopecia), itchy skin (pruritus), fever (pyrexia), feeling tired (fatigue), influenza like illness, severe infection (meningococcal infection), sepsis, septic shock, viral infection, , lower respiratory tract infection, stomach flu (gastrointestinal infection), cystitis, infection, fungal infection, collection of pus (abscess), type of infection of the skin (cellulitis), influenza, sinusitis, tooth infection (abscess), relatively few platelets in blood (thrombocytopenia), low level of lymphocytes a specific type of white blood cells (lymphopenia), feeling your heartbeat, serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction), hypersensitivity, tingling in part of the body (paresthesia), shaking, sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder, dyspnoea (difficulty breathing), nose bleed, stuffy nose (nasal congestion), throat irritation, runny nose (rhinorrhoea), inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen), constipation, stomach discomfort after meals (dyspepsia), abdominal distension, hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating, muscle cramp, muscle aches, back and neck pain, bone pain, joint swelling, pain in the limbs (arms and legs), kidney disorder, difficulties or pain when urinating (dysuria), blood in urine, swelling (edema), chest discomfort, feeling of weakness (asthenia), chest pain, infusion site pain, chills, increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen. These measures will help protect the environment. SOLIRIS is used to treat: SOLIRIS is used to treat: • patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH) Soliris is used for the treatment of patients with a disease that affects red blood Ensure that your current meningococcal vaccination is up to date. Soliris is given through an infusion into a vein (intravenous, IV). Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms). By reporting side effects, you can help provide more information on the safety of this medicine. for safe disposal. Solaris was developed by Sun Microsystems and has been owned by the Oracle Corporation since its take-over of Sun in early 2010. Soliris can be used on children under doctor’s supervision. Soliris is a prescription medicine called a monoclonal antibody. When suggestions are available use up and down arrows to review and ENTER to select. Subjects who undergo plasma exchange may receive additional doses of Soliris. If you forget or miss a Soliris infusion, call your doctor immediately. This includes any possible side effects not listed in this leaflet. Human translations with examples: soliris, Önnek beadni, c04002 soliris, soliris ekulizumab. Decreased urination (problems with your kidneys). Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). Your doctor will calculate this. 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. A significant fall in your red blood cell counts (anaemia). Like all medicines, this medicine can cause side effects, although not everybody gets them. Interrupting or stopping treatment with Soliris may cause your gMG symptoms to come back. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. system that mainly affects the eye nerves and the spinal cord called Neuromyelitis Your doctor may wish to test your body’s response to Soliris or may wish to test your as thrombotic microangiopathy or TMA). Solaris is a proprietary Unix operating system originally developed by Sun Microsystems.It superseded the company's earlier SunOS in 1993. 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 . Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells. Talk to your doctor if you are breastfeeding or intend to breastfeed. In patients with NMOSD, their eye nerve and spinal cord are attacked and damaged by the immune system which can lead to blindness in one or both eyes, weakness or paralysis in the legs or arms, painful spasms, loss of sensation, and markedly impaired activities of daily living. Soliris will be stored in refrigerated conditions (2°C to 8°C) in the hospital or Soliris vials in the original package may be removed from refrigerated storage (up of patients with a disease that affects red blood cells called Paroxysmal Nocturnal These are rare, life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml). 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. NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. not store it: If you no longer need to use this medicine or it is out of date, take it to any pharmacy SOLIRIS is a prescription medicine called a monoclonal antibody. It also moved to the PowerPC architecture in version 2.5.1 but was canceled when its port was released immediately. Continue typing to refine. All medicines can have side effects. 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 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. You may need to read it again. Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). Description. of their red blood cells. effects with you and explain the risks. This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. Some medicines may interfere with Soliris and affect how it works. 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. 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 to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria (PNH). You are allergic to eculizumab rmc, or any of the ingredients listed at the end of Uraemic Syndrome (aHUS). The effects of this medicine on a person’s ability to drive and use machines were Soliris is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia. More instructions can be found in Section. 2. urine, kidney failure, shortness of breath and blood clots. For further information call emc accessibility on 0800 198 5000. 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. What is Eculizumab (Soliris) used for? 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. of your red blood cells. and destroy its own vulnerable blood and kidney cells. Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. pharmacy. Interrupting or stopping treatment with Soliris may cause your NMOSD to worsen and relapse to happen. Unless you are planning to become pregnant, you should Soliris® (eculizumab) treats anti-AChR antibody-positive gMG. low blood counts (low platelets and anaemia), tiredness and difficulty functioning. Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. Soliris is used to treat adults and children patients with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). protective proteins and their red blood cells can be destroyed. Soliris is a pharmaceutical used to treat an orphan disease, atypical hemolytic-uremic syndrome (aHUS). 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. In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living. discuss the risks and benefits for you and your child if you breastfeed whilst on PNH patients lack these What you need to know before you use Soliris, Meningococcal and other Neisseria infections alert. Interrupting or ending treatment with Soliris may cause your PNH symptoms to come back more severely soon. There have been no reported overdoses of Soliris. In some cases, health care professionals may use the trade name Soliris when referring to the generic drug name eculizumab. 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. It can be used for treating serious kidney disorder called atypical hemolytic uremic syndrome (aHUS). To bookmark a medicine you must sign up and log in. Symptoms or problems from red blood cell breakdown include: a large drop in your red blood cell count causing anaemia. If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”. 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. Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms). If you experience any of these symptoms, contact your doctor immediately. 6. (Aust R 138885). Haemoglobinuria (PNH). Your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris. After you have received medical advice for any side effects you experience, you can If you experience any of the following symptoms, you should immediately inform your doctor: Treatment for meningococcal infection while travelling. Soliris is a monoclonal antibody. News-Medical speaks to Dr. Mahshid Dehghan about her latest research into diet, and how a diet high in carbohydrates could increase your risk of heart disease. If you suspect that you have been accidentally administered a higher dose of Soliris than prescribed, please contact your doctor for advice. 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 How it works. These highlights do not include all the information needed to use SOLIRIS safely and effectively. To email a medicine you must sign up and log in. Possible side effects Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing. The data suggest that Soliris may be suitable for gMG patients with these features and who also check predefined eligibility criteria. under Section. What is Soliris used for? WARNING: SERIOUS MENINGOCOCCAL INFECTIONS . Consumer Medicine Information (CMI) summary. This includes any possible side effects not listed in this leaflet. Solaris uses a common code base for architectures where it supports SPARC and X86 (including AMD64/EM64T). infection by fungi (Aspergillus infection), infection of the joint (arthritis bacterial), skin tumor (melanoma), bone marrow disorder. SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). hours in paediatric patients. From Wikipedia, the free encyclopedia Not to be confused with ocrelizumab. is not for use in this patient population. How to use Soliris Soliris is used for the treatment of patients with a disease that affects red blood cells called Paroxysmal Nocturnal Haemoglobinuria (PNH). 3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB111EZ, UK. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). In unaffected individuals, these proteins protect red blood Patients with aHUS have an inflammatory condition which affects the blood system and In this way Soliris improves anaemia, fatigue, and other signs SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse. Your doctor will discuss the possible side effects and risks with you. Common Brand(s): Soliris This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). Soliris is also used to treat atypical hemolytic uremic syndrome (aHUS). Keep this medicine out of the sight and reach of children. taking this medicine. Consult your doctor before you take Soliris to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. 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 block the body’s inflammatory response, and its ability to attack and destroy its own muscles to improve muscle contraction, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living. The most serious side effect was meningococcal sepsis. How to store Soliris Data in a limited number of pregnant women treated with Soliris do not indicate that This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. use adequate contraception whilst being treated with Soliris (and up to 5 months after Soliris is a concentrate that is made up into a solution for infusion. Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS). It is important to have the infusion with Soliris at the appropriate time to make Side effects of Ultomiris and Soliris that are similar include headache, diarrhea, and nausea. Confusion or change in how alert you are, An increase in your serum creatinine level (problems with your kidneys), or. 2. Eculizumab is also used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. with these terms and conditions. A significant rise in destruction of your red blood cells. headaches, being short of breath when exercising, dizziness and looking pale. Do not throw away any medicines via wastewater. 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. Soliris is used to treat adults and children with: • paroxysmal nocturnal haemoglobinuria (PNH); • atypical haemolytic uremic syndrome (aHUS). SOLIRIS (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007 . A significant fall in your platelets (thrombocytopenia). You can also report side effects directly via the national reporting system listed below. Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable blood and kidney cells. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. 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. That’s a book of business savings of $52.5 million for Soliris. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Neuritis; Myasthenia Gravis; Hemolytic Uremic Syndrome; Paroxysmal Nocturnal Hemoglobinuria Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS). Prime’s site of care policy restricts Soliris administration from hospital administration. Soliris is also used to treat adult patients with a certain type of disease affecting the muscles and called generalized Myasthenia Gravis (gMG). The text only version may be available in large print, Braille or audio CD. This results in anaemia (low red blood cell counts), thrombosis (formation of blood clots in the blood vessels) and dark urine. Soliris has not been studied in children and adolescent patients with NMOSD. Soliris contains the active ingredient eculizumab rmc. 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. Prime also revised the reimbursement equation used with providers to give them a more reasonable margin and us the savings we needed: For more information, including what to do if you have any side effects, see Section. The expiry date refers to the last day of that month. What should I know before I use Soliris? As Soliris is given to you under Following each infusion, you will be monitored for about one hour. This can lead to low Soliris is a clear and colorless solution. 5. discontinuing treatment). Please note that medical information found Studies with Soliris did not examine the risk of relapse of NMOSD if treatment with Do not use this medicine after the expiry date. supermarket or health food shop. Your doctor’s instructions should be carefully observed. Soliris is also used to treat patients with a condition called atypical Haemolytic Uraemic Syndrome (aHUS). An orphan disease by definition effects 200,000 people or less in the United States. There are also links to other websites about rare diseases and treatments. Remind any doctor, nurse, pharmacist or dentist you visit that you are using Soliris. However, some side effects may need medical attention. SOLIRIS is used to treat: patients-with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). Read all of this leaflet carefully before you start using this medicine because it contains important information for you. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). It is given in a clinic by intravenous (IV) infusion. Other side effects not listed here may occur in some people. Your doctor will discuss the possible side If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor. The effect of using Soliris on other medicines has not been studied. Patients with PNH lack naturally occurring protective proteins on the surface of some of their red blood cells. listed at the end of the CMI. of the lung (pneumonia), kidney infection), sepsis -, high fever, chills, confusion, rapid breathing, dizziness, light headedness or shakes, serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic The original leaflet can be viewed using the link above. 5. What should I know while using Soliris? Soliris 2. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Soliris (Eculizumab injection) is a monoclonal antibody. not assessed as part of its registration. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Soliris contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. report side effects to the Therapeutic Goods Administration online at. and its ability to attack and destroy its own eye nerves, brain and spinal cord. 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. This leaflet provides important information about using Soliris. If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with Soliris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. 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. immediately. frequency and dose that varies depending on their weight, Children and adolescents who weigh more than 40kg are treated with the adult dosing. Soliris is also used to treat patients with a condition called atypical Haemolytic Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. Patients with PNH lack naturally occurring protective proteins on the surface of some 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). The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins. product can be put back in the refrigerator. adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). SOLIRIS is a medicine that contains the active substance ECULIZUMAB and is available as Vial. Soliris in clinical trials to 25°C) for only one single period of up to 3 days. Name: SOLIRIS Generic Name: ECULIZUMAB Strength: 300 mg single-use vials containing 30 mL of 10 mg/ml. Soliris is also used to treat adult patients with a disease of the central nervous It contains the active substance eculizumab. 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. Your doctor will … If you are having plasma exchange or plasma infusion you may receive additional doses and symptoms of PNH. Soliris is designed to block part of the immune system called the terminal complement cascade, consisting of a series of reactions that trigger the damaging immune response seen in myasthenia gravis. 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.

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