how long does nintedanib take to work

Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. However, it has been shown to slow the decline of lung function over time. N Engl J Med 2005; 353: 22292242. And be sure to drink plenty of fluids. In addition to the use listed above, Ofev may be used for other purposes. This was consistent with the annual rate of FVC decline in patients treated with Ofev in the INPULSIS trials (-113.6 mL/year in patients treated with Ofev). Nintedanib should always be taken with or straight after meals. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms. Hutchinson J, Fogarty A, Hubbard R, et al. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid, taken twice daily approximately 12 hours apart. Examples of these side effects include: Also, Ofev can sometimes cause liver problems. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away. To read more about digestive side effects, see the Ofev side effects section above. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. The mechanical phenotypic plasticity of melanoma cell: an emerging driver of therapy cross-resistance. It's recommended if breathing tests have shown your lung capacity is 50% to 80% of what would normally be expected. Some tips to help treat these include drinking fluids to stay hydrated, having a healthy and balanced diet, and using medications (antidiarrheals or antiemetics) if your provider says it's safe to do so.If you have diarrhea, nausea, and vomiting, or symptoms of low body fluids, such as feeling light-headed and . There arent any other herbs or supplements that have been specifically reported to interact with Ofev. Nintedanib may cause other side effects. Use of the terms male and female in this article refers to sex assigned at birth. "These findings offer real hope to people with IPF and provide further supportive evidence for the long-term efficacy of Ofev. Talk with your doctor about what birth control method is right for you during this time. Do not use two doses at one time. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Talk with your doctor about using a form of birth control that isnt affected by vomiting or diarrhea, such as an injection or implant. Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests. About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. You should stop smoking before you start taking nintedanib and avoid smoking during your treatment. Tyrosine kinases play an important role in cell growth, differentiation, and metabolism and there is substantial evidence that certain tyrosine kinases, notably platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), as well as non-receptor tyrosine kinases, are associated with scar tissue and the progression of pulmonary fibrosis and other interstitial lung diseases. To treat interstitial lung disease * with scarring, the usual dosage of Ofev is 150 mg two times per day. Its important to have prompt diarrhea management if you have this side effect. Gastrointestinal events, mainly diarrhoea, are the main adverse events caused by the treatment. Use this . Copyright, 2023. Ofev is an effective treatment for idiopathic pulmonary fibrosis. No up-titration upon initiation. -. official website and that any information you provide is encrypted Your doses may be delayed if you have certain side effects. Ofev comes. * This is a partial list of mild side effects from Ofev. The exploratory findings of the open-label extension trial are consistent with results from the Phase III INPULSIS trials and show that continued treatment with Ofev, for up to 68 months, has a manageable safety and tolerability profile, with no new safety signals identified. NINTEDANIB IS A MULTI-TARGETED TYROSINE KINASE INHIBITOR THAT WORKS BY INHIBITING PATHWAYS INVOLVED IN THE PATHOGENESIS OF ILDs 1-3. . Interstitial tissue (also called interstitium) is a network of tissue that runs throughout your lungs and supports the alveoli (tiny air sacs). This content does not have an Arabic version. Epub 2018 Jan 12. Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ofev. Avoid taking an herbal supplement containing St. John's wort. Note that the lung diseases Ofev is prescribed to treat can also cause fatigue. Multi-Targeting Approach in Selection of Potential Molecule for COVID-19 Treatment. All Rights Reserved. The scientific evidence shows that nintedanib is effective and well tolerated for the treatment of IPF in mild, moderate and severe stages of the disease. It can lead to fatal complications. New Data Shows OFEV (nintedanib) Efficacy is Sustained Long-term with No New Safety Signals in Patients with IPF Ridgefield, Conn., Tuesday, 09/29/2015 - 14:00 Interim analysis of INPULSIS-ON, an open-label extension study, shows beneficial effect of OFEV on slowing disease progression was maintained and the change from baseline in FVC was . swelling under your skin, typically in your eyelids, lips, hands, or feet, swelling of your tongue, mouth, or throat, foods containing the artificial sweetener xylitol, if you have certain side effects with Ofev, widening and rounding of the tips of your fingers or toes, known as, Blood thinners. Cardiovascular (major adverse cardiac and vascular events, e.g., heart attack or stroke) and bleeding exposure-adjusted event rates collected in patients who continued or initiated Ofev in INPULSIS-ON were similar to those observed in placebo-treated patients in the INPULSIS trials. Ofev can cause mild or serious side effects. All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it. Before taking Ofev, talk with your doctor about your health history. The incidence rate of acute exacerbations in INPULSIS-ON was similar to that in patients treated with Ofev in the INPULSIS trials, further supporting the effect of Ofev on reducing the risk of acute exacerbation. Ofev is also used to treat chronic (long lasting) interstitial lung disease in which the scar tissue keeps getting worse. 2023 Feb 14;24(4):3818. doi: 10.3390/ijms24043818. Nintedanib is a tyrosine kinase inhibitor with antifibrotic properties that has also been shown to significantly reduce the progression of the disease. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. You could also download a reminder app on your phone. In this review, we will discuss the clinical trial evidence and real-world experience for nintedanib in the management of IPF. Systemic sclerosis that affects your lungs is a form of interstitial lung disease. Take with food and a full glass of water. Talk to your doctor about birth control methods that you can use during your treatment and for at least 3 months after your last dose of nintedanib. You take dabrafenib twice a day, morning and evening, about 12 hours apart. The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS-ON. You should always consult your doctor or another healthcare professional before taking any medication. At this time, use of both anti-fibrotic drugs is limited to the diagnosis of IPF but will likely see expansion to non-IPF interstitial lung disease in the near future. How does nintedanib work? It can cause symptoms such as: The scarring in your lungs typically gets worse over time, causing your symptoms and lung function to worsen as the condition progresses. Side effects, including photosensitivity rash with pirfenidone and loose stools with nintedanib, may lead to drug intolerance and early discontinuation. To learn more about saving money on prescriptions, see this article. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. If you would like to notify the FDA about a side effect youve had with Ofev, you can do so through MedWatch. Ofev is not approved for use by anyone younger than 18 years old. As IPF progresses, lung function gradually and irreversibly deteriorates. MeSH Do not crush or chew because the drug has a bitter taste. Before taking Ofev, talk with your doctor and pharmacist. Take nintedanib exactly as directed. If you think youve taken too much of this drug, call your doctor. However, in clinical trials, hair loss was rare with Ofev. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. These are not all the possible side effects of Ofev. Your doctor will determine the best dosage to fit your needs. Talk with your doctor about the method of birth control thats right for you. - INPULSIS-ON study indicates safety and efficacy of Ofev (nintedanib) are maintained over the long term and consistent with prior findings from INPULSIS trials, - Results from INPULSIS-ON, the open-label extension from the two INPULSIS Phase III trials, published in Lancet Respiratory Medicine. antifibrotic; idiopathic pulmonary fibrosis; interstitial lung disease; nintedanib. Idiopathic pulmonary fibrosis is a form of interstitial lung disease. The https:// ensures that you are connecting to the You take nintedanib with docetaxel as part of a 21 day cycle of treatment . The INPULSIS-ON trial featured a large cohort of patients with IPF who received Ofev, and these data add to the growing body of evidence suggesting that Ofev provides long-term benefits to patients with IPF. It is not known if Ofev is safe and effective in children. This is not a complete list of side effects and others may occur. Keep all appointments with your doctor and the laboratory. 2015;8(Spec Feature):101-104. Nintedanib capsules come in two different strengths: 150mg and 100mg. Chronic Fibrosing Interstitial Lung Disease With A Progressive Phenotype, Systemic Sclerosis-Associated Interstitial Lung Disease. Your doctor might prescribe an immunosuppressant if your lung condition is caused by an autoimmune condition. What special precautions should I follow? New study results provide evidence that Ofev (nintedanib) slows progression of IPF beyond four years with consistent safety - INPULSIS-ON study indicates safety and efficacy of Ofev. sharing sensitive information, make sure youre on a federal For more information about taking Ofev during pregnancy, see the Ofev and pregnancy section above. Maximum dose: 300 mg/day How long does it take for Ofev to start working? Epub 2021 Mar 25. You usually keep taking nintedanib for 20 days. A generic drug is an exact copy of the active drug in a brand-name medication. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. RIDGEFIELD, Conn., Sept. 17, 2018 /PRNewswire/ -- Results from INPULSIS-ON, published today in Lancet Respiratory Medicine, provide insights into the long-term safety, efficacy and tolerability of Ofev (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF). It belongs to a class of drugs called tyrosine kinase inhibitors. Women should not become pregnant while taking nintedanib. What special dietary instructions should I follow? All rights reserved. Its not currently available in generic form. Descriptive efficacy assessments of lung function showed the annual rate of decline in forced vital capacity (FVC) over 192 weeks was -135.1 mL/year. SOURCE Boehringer Ingelheim Pharmaceuticals, Cision Distribution 888-776-0942 Nintedanib comes as a capsule to take by mouth. If you miss a dose of this medicine, take your next dose at your regular time. They can tell you about other medications that may work well for you. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Before approving coverage for Ofev, your insurance company may require you to get prior authorization. Ofev comes as a capsule that you take by mouth. Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. 17 The effect of nintedanib on slowing FVC decline was consistent across patient subgroups defined by baseline characteristics including sex, race Unfortunately, such studies have been more equivocal than confirmatory of clinical or survival benefit. It works by blocking the action of enzymes involved in causing fibrosis. Ofev is an effective treatment for chronic interstitial lung disease with worsening fibrosis. High-dose acetylcysteine in idiopathic pulmonary fibrosis. What is the mechanism of action of nintedanib? The drug hasnt been studied during pregnancy. Take nintedanib with food. You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test. Call your doctor right away if you have serious side effects. This causes your lung function to decline and your symptoms to worsen as the condition progresses. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Your body needs oxygen to function normally and produce energy. Exogenous Thymosin Beta 4 Suppresses IPF-Lung Cancer in Mice: Possibly Associated with Its Inhibitory Effect on the JAK2/STAT3 Signaling Pathway. We comply with the HONcode standard for trustworthy health information. Keywords: Clinical trials to date have excluded people with FVC of less than 50 percent predicted, leaving little understanding of how treatment affects people with more-advanced disease. Detailed Nintedanib dosage information What are the side effects of nintedanib? If you dont have insurance, you can ask your doctor or pharmacist about online pharmacy options. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Anaprox, Naprelan); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); erythromycin (E.E.S., Ery-Tab, Eryc); ketoconazole; laxatives; oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone; phenytoin (Dilantin, Phenytek); pirfenidone (Esbriet); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); or stool softeners. If youre able to become pregnant, your doctor will want you to have a pregnancy test before you start taking Ofev. Also, its important to drink plenty of fluids while you have diarrhea to help prevent dehydration. This tells your doctor the effect your lung disease has on your ability to inhale and exhale, and this measurement, alongside others such as worsening symptoms or worsening imaging, determine how effective nintedanib is for you at slowing disease progression. Pooled data from both trials indicated that nintedanib reduced the decline in FVC by 112.4 mL/year compared with 223.3 mL/year for placebo, a difference of 109.9 mL/year (95% CI 75.9 to 144.0). Drug class: Multikinase inhibitors. Take OFEV exactly as your doctor tells you to take it Your doctor will tell you how much OFEV to take and when to take it Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Nintedanib inhibits the following RTKs: Research has shown that nintedanib starts to improve FVC within 6 weeks of starting the medication. The capsules should be swallowed whole with a drink. http://www.upandaway.org. Bronchiectasis is a lung condition that causes persistent cough and excess phlegm. Ofev capsules should be stored at room temperature in a tightly sealed container. As with most drugs, some people can have an allergic reaction after taking Ofev. Lysosomes as a Target of Anticancer Therapy. Ofev can interact with several other medications. Accessibility For advanced melanoma you take dabrafenib and trametinib for as long as they are working or until the side effects get too bad. Nintedanib inhibits a variety of receptor and nonreceptor tyrosine kinases these are signaling proteins that work as an ON/OFF switch in many cell-to-cell communications. Comments: . Interstitial lung disease associated with systemic sclerosis makes breathing difficult. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives. Nintedanib can cause birth defects or death to an unborn baby. are pregnant or plan to become pregnant. tell your doctor if you or anyone in your family has ever had a bleeding problem, if you have or have ever had liver or heart disease, diverticular disease (diverticulitis; small pouches in the lining of the large intestine that can become inflamed), or blood clots, and if you have had recent abdominal surgery. Actemra, Ofev, tocilizumab, pirfenidone, Esbriet, Actimmune, interferon gamma-1b. Ofev is not available in a generic form. The .gov means its official. Cigarette smoking may decrease the effectiveness of this medication. It's normally taken as capsules 3 times a day. These lung conditions can also cause a cough and breathing difficulties, which can stop you getting enough sleep. Ofev is FDA-approved to treat chronic (long-term) interstitial lung disease with worsening fibrosis (scarring) in adults. However, you should still check with your doctor or pharmacist before using any of these products while taking Ofev. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. The site is secure. However, if you have certain side effects with Ofev, drinking alcohol could make them worse. The American Thoracic Society recommends Ofev as a treatment option for this condition. Erythromycin is an antibiotic drug used to treat, Rifampin (Rimactane, Rifadin). An example of another drug that may treat idiopathic pulmonary fibrosis is pirfenidone (Esbriet). Would you like email updates of new search results? This could increase your risk for side effects from Ofev. It also makes the air sacs less efficient at transferring oxygen into your bloodstream. The Food and Drug Administration (FDA) approves prescription drugs such as Ofev to treat certain conditions. Swallow the capsule whole and do not crush, chew, break, or open it. Brand name: Ofev Increased risk of bleeding. If your local pharmacy doesnt have these options, your doctor or pharmacist may be able to direct you to one that does. What side effects can this medication cause? Swallow the capsules whole with liquid; do not chew or crush them. It is also used to treat certain types of chronic fibrosing interstitial lung diseases (ILD; an ongoing disease in which there is increased scarring of the lungs). The careful selection of trial participants limits applicability of outcomes to patients typically seen in practice. Both Ofev and Esbriet slow IPFs worsening but do not stop its progression, and neither medication is recommended over the other. Examples of drugs that may interact with Ofev include: Taking Ofev with St. Johns wort may cause Ofev to be less effective. Drug class: Multikinase inhibitors. The scar tissue causes stiffness in your lungs that makes it harder for your lungs to expand when you breathe in. The Ofev dosage your doctor prescribes will depend on several factors. Call your doctor if you have any unusual problems while taking this medication. Different interactions can cause different effects. Ofev can cause birth defects or death in an unborn baby. Some supplements may help with the symptoms of lung disease. 2022 Sep 2;13(9):760. doi: 10.1038/s41419-022-05207-8. Participants received Ofev treatment for an average period of 27.7 months, with some patients receiving the treatment for a maximum of 93.1 months. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. If you use hormonal birth control (birth control pills, injections, implants, skin patches, or vaginal rings), also use a barrier form of birth control to prevent pregnancy while taking Ofev. Global incidence and mortality of idiopathic pulmonary fibrosis: a systematic review. This can also lead to fatigue. To use the sharing features on this page, please enable JavaScript. Am J Respir Crit Care Med 2011; 183: 431440. Chronic Fibrosing Interstitial Lung Disease With A Progressive Phenotype, Systemic Sclerosis-Associated Interstitial Lung Disease, colony-stimulating factor 1 receptor (CSF1R). If you have any queries about your deliveries you can contact Polar Speed directly on 0800 7833178. Researchers explore whether senescence-associated secretory phenotype (SASP) is a potential driver of age-related dysfunction, Updates in interstitial lung disease: Current facets of anti-fibrotic therapy, Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education, Mayo Clinic School of Continuous Professional Development, Financial Assistance Documents Minnesota, Pulmonary, Critical Care, and Sleep Medicine, Anti-fibrotic therapy in the treatment of IPF: Ongoing concerns and current practices. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor. 2023 Jan 22;24(3):2176. doi: 10.3390/ijms24032176. Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Drugs. In the INPULSIS-ON trial, involving 734 patients: The most common adverse event during INPULSIS-ON was diarrhea, as in the INPULSIS and TOMORROW trials, and led to treatment discontinuation in 4.7% and 10.2% of patients who continued and initiated Ofev during INPULSIS-ON, respectively. If youre concerned about hair loss with Ofev, talk with your doctor. How often do you take dabrafenib and trametinib? While multiple trials assessing different mechanisms and approaches to treatment have proved negative over the past decade and a half, two drug therapies have recently become available for the directed treatment of idiopathic pulmonary fibrosis (IPF). Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease. To make sure Ofev is safe for you, tell your doctor if you have ever had: bleeding problems (in you or a family member); if you take a blood thinner such as warfarin (Coumadin, Jantoven). If youre not sure if youll need prior authorization for Ofev, contact your insurance company. Usual Adult Dose for Idiopathic Pulmonary Fibrosis: 150 mg orally every 12 hours (A class of drugs is a group of medications that work in a similar way.). There arent any foods that have been specifically reported to interact with Ofev. You should not become pregnant while you are taking nintedanib; the medication may harm your unborn baby. Eur Respir J 2015; 46: 795806. Medically reviewed by Judith Stewart, BPharm. The primary objective of the INPULSIS-ON trial was to characterize the long-term safety and tolerability of Ofev in patients with IPF, assessed via clinical and laboratory evaluation and the recording of adverse events. The American Thoracic Society recommends Ofev as a treatment option for this condition. Swallow the capsules whole with a liquid. Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests. Evidence-based recommendations on nintedanib (Ofev) for adults with idiopathic pulmonary fibrosis. Is the ketogenic diet right for autoimmune conditions? Oncogenesis. Rifampin is an antibacterial drug mainly used to treat. It is used for types of ILD that cause scarring in the lungs such as idiopathic pulmonary fibrosis (IPF), certain chronic fibrosing interstitial lung diseases (ILDs) and nintedanib helps lung function in people with systemic sclerosis-associated interstitial lung disease. This date is typically 1 year from the date they dispensed the medication. Interstitial lung disease is a name used for several conditions that involve inflammation and scarring in the interstitial tissue in the lungs. Your doses should be taken about 12 hours apart with food. See Important information section above. Keep in mind that you may be able to get a 90-day supply of Ofev. Cell Death Dis. You should not start taking nintedanib until a pregnancy test has shown that you are not pregnant. URL of this page: https://medlineplus.gov/druginfo/meds/a615009.html. This helps prevent others, including children and pets, from taking the drug by accident. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. What should I tell my doctor before using Ofev? Be sure to learn about the basics of PF, how it is treated, how to live well and where to get support. If you have a question that is not answered, call our free Lung HelpLine at 1-800-LUNGUSA (1-800-586-4872). Last updated on Apr 20, 2022. Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update. Careers. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John's wort. Duplication for commercial use must be authorized by ASHP. You should not breastfeed while taking Ofev. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Ofev comes in two strengths: 100 milligrams (mg) and 150 mg. For the types of lung disease Ofev is approved to treat, the usual recommended dosage is 150 mg twice per day. For instance, you can take one capsule of OFEV in the morning and one in the evening. When pooling data for two of the pirfenidone trials, 21 percent of participants still had FVC decline greater than 10 percent while on therapy. Viruses. If you experience side effects from Ofev such as diarrhea, nausea, and vomiting it may help to avoid the following foods and drinks: It takes 6 to 12 weeks for Ofev to start working, which has been measured in clinical trials of people with interstitial lung disease as less of a change in lung capacity (as measured by an FVC or Forced Vital Capacity) after at least 6 weeks in those prescribed Ofev. Note that Ofev commonly causes vomiting or diarrhea, which can make birth control pills less effective. If you have trouble opening medication bottles, ask your pharmacist if they can put Ofev in an easy-open container. Panlobular emphysema affects the entire lung and causes coughing, wheezing, and breathing difficulties. If you become pregnant while taking Ofev, tell your doctor right away. Do not take more than 300 milligrams of nintedanib in one day. If you and your doctor determine that Ofev is safe and effective for you, youll likely take it long term. Thats because these lung conditions stop your body getting enough oxygen. No, Ofev isnt an immunosuppressant drug. It can help slow down the scarring in your lungs and worsening lung function. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. This medication is available to patients through specialty pharmacies. However, be sure to take the dosage your doctor prescribes for you. Your doctor should do certain blood tests before you start taking this medicine. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

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