Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. News and Events Canadian Medical Imaging Inventory CADTH has released the 2020 Canadian Medical Imaging Inventory (CMII). Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vascepa only for the indication prescribed. Missed Dose If you miss a dose, take it as soon as you remember. HOW SUPPLIED Dosage Forms And Strengths . -Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before initiating therapy and should continue this diet and exercise regimen during therapy. VASCEPA is not … The Vascepa medication above is manufactured by Amarin Pharmaceuticals. 3.1 Recommended Dose and Dosage Adjustment The dose of VASCEPA is 4 grams per day, taken as two 1 g capsules twice a day with food. Use the medicine exactly as directed. The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day VASCEPA dose group. Amarin Pharma, Inc. understands that your personal and health information is private. Dosage and Administration. Msg frequency varies. Icosapent Ethyl Information. Heart rhythm problems (atrial fibrillation). This product may contain inactive ingredients, which can cause allergic reactions or other problems. Vascepa is a prescription medication used along with a low-fat and low-cholesterol diet to treat high triglyceride levels. Call toll FREE 1(877)745-9217 to talk with our Canadian customer service team in Vancouver, BC. Patients treated with VASCEPA had fewer cardiovascular events (17.2%) compared to those who took placebo (22%). The incidence of nausea was dose-dependent. Text HELP for help. In some people, hair loss may be due to a medical condition, another medication, diet or stress levels. There were … Continue reading, It takes approximately one year for Vascepa to start reducing a person's cardiovascular risk and up to almost five years for the full risk-reducing effects to be seen. Twice daily . See TNT trial. 3.1 Recommended Dose and Dosage Adjustment The dose of VASCEPA is 4 grams per day, taken as two 1 g capsules twice a day with food. If you miss a dose of Vascepa (icosapent ethyl), a prescription fish oil treatment for high triglycerides, take it as soon as you remember it. HCP Dose Card Phase 1 HLS20VAXXXXXX HLS/Vascepa 100% 100% 8" w x 5" h 8.5" w x 5.5" h 9" w x 6" h 8.5" x 5.5" None Cyan, Magenta, Yellow, Black JOB INFO SAVED AT 4-16-2020 6:31 PM STUDIO Sandra Noto LASER PRINTED AT None LAST ROUND REVIEWED ON Date: None Build: None FIRST ROUND SETUP Creative Medical PS Production Proofreader Events PRINT APPROVALS … Usual Adult Dose for Cardiovascular Risk Reduction: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. In the US, Customers can order Vascepa online , or as the generic alternative, Icosapent Ethyl as well as many more quality medications from PrescriptionPoint.com. DOSAGE FORMS AND STRENGTHS VASCEPA capsules are supplied as 1gram amber-colored soft-gelatin capsules bearing the designation AMR101. There was also the ... High dose statins is standard of care in this population with sub 70 LDL targets and Vascepa added to target TG sub 150 ideally. It is not known whether Vascepa will lower your risk of pancreatitis (inflammation of your pancreas). Do not break open, crush, dissolve, or chew VASCEPA. -As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with triglyceride levels of 150 mg/dL or higher and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. Follow your doctor's instructions very closely. Message frequency varies. We note that Amarin settled a similar patent litigation with Teva Pharmaceuticals TEVA in 2018. two 1 gram capsules twice daily with food. Reddy's Laboratories’ RDY abbreviated new drug application, seeking approval for the generic version of 0.5mg and 1mg dosage of Vascepa as a treatment of hypertriglyceridemia was also approved by the FDA last month. Available in 1000 mg. Find patient medical information for Vascepa oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Do not break open, crush, dissolve, or chew VASCEPA. The daily dose of VASCEPA is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as; two 1 gram capsules twice daily with food. TERMS AND CONDITIONS. Call now 1-855-402-2022 . Advise patients to swallow VASCEPA capsules whole. Has the drug been reviewed by the Common Drug Review (CDR)? 1-855-402-2022 Toll ... To comply with Canadian International Pharmacy Association regulations you are permitted to order a 3-month supply or the closest package size available based on your personal prescription. Vascepa Dosage & Precautions ... Canada residents can call a provincial poison control center. The Amarin group of companies is not responsible for material contained on other non-Amarin … Eine fettreduzierte Diät begrenzt die Menge an Fett, die Sie jeden Tag konsumieren können. $3,863a. 4. Call toll FREE 1(877)745-9217 to talk with our Canadian customer service team in Vancouver, BC. Advise patients to swallow VASCEPA capsules whole. (see the note below this table.) Baseline characteristics were comparable between groups. También ha logrado la aprobación en Canadá. 3.3 Missed Dose Tell your doctor if you are breastfeeding. Available for Android and iOS devices. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product is ultimately approved by Health Canada. along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. The risk of bleeding is higher in people who also take other medications or supplements that increase bleeding risk such as aspirin, clopidogrel, dabigatran, warfarin, NSAIDs, feverfew, ginkgo, garlic, or ginseng. Do not break open, crush, dissolve, or chew VASCEPA. Follow your diet, medication, and exercise routines very closely. Distribution: The mean volume of distribution at steady-state of EPA is approximately 88 liters. By browsing our website, you agree to our use of cookies. HOW SUPPLIED Dosage Forms And Strengths. VASCEPA, a highly purified omega-3 fatty acid available by prescription, was given at a dose of 8 grams daily for 3 days and then 4 grams daily for 11 days (total treatment 2 … By only containing EPA, Vascepa reduces high triglycerides without raising levels of “bad” cholesterol or LDL-C. Vascepa is also up to four times stronger than most OTC fish oils, more expensive, carries a higher risk of bleeding and heart rythym disturbances, and is only available on prescription to people who meet certain criteria. Order Vascepa (Icosapent Ethyl) from Canada, at lower prices to the U.S. Patients in the Vascepa arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. The DPD is updated nightly and includes: availability of the drug in Canada ; product monograph (PM) for human drugs ; labels for animal drugs; Generic drug manufacturers must update their PM to ensure it aligns with the Canadian Reference Product. Last updated on March 4, 2020. VASCEPA, a highly purified omega-3 fatty acid available by prescription, was given at a dose of 8 grams daily for 3 days and then 4 grams daily for 11 days (total treatment 2 weeks). If you prefer the smaller size, take four of the 0.5-gram capsules twice a day with food. What are the possible side effects of VASCEPA? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Vascepa (icosapent ethyl) is a prescription omega-3 fatty acid that is similar to fish oil but not exactly the same. Contact your doctor for further advice. Our CIPA affiliate pharmacies are recognized globally as the first choice in prescription and non-prescription medicine. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Select one or more newsletters to continue. While the NDS includes results from the REDUCE-IT™ cardiovascular outcomes study of Vascepa, review of this regulatory submission in Canada is anticipated to be independent of the review of the supplemental new drug application whic Warum sollte ich einer fettreduzierten Diät folgen? Patients randomized to the … Initial dose-titration was beneficial in reducing the occurrence of nausea. The daily dose of VASCEPA is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as. Vascepa In Canada. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Patients randomized to the non-active arm received usual care. Nausea was reported by approximately 30% of patients treated with CHAMPIX1.0mg BID after an initial week of dose titration. Our online pharmacy allows you to purchase medication 24 hours a day and 7 days a week. Msg and data rates may apply. Follow all directions on your prescription label and read all medication guides or instruction sheets. read more. Capsule . Health Canada's federal regulatory role over drugs and health products; links to adverse reactions, advisories and recalls, legislation, compliance, enforcement, MedEffect, controlled substances, natural health, biotechnology, radiopharmaceutical and veterinary products, international activities, public consultations, reports, research and publications Both C: max: and AUC increased in approximate proportion to the VASCEPA dose. 1,2 (Note that in Canada it is approved for the indication of severe hypertriglyceridemia only.) Swallow capsules whole. VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients. Tell your doctor about all your other medicines, especially: a blood thinner - warfarin, Coumadin, Jantoven. to prescribe VASCEPA. BEDMINSTER, N.J., and … Usual Adult Dose for Hypertriglyceridemia: 2 g orally twice a day with food Patients randomized to the … Other drugs may interact with icosapent, including prescription and over-the-counter medicines, vitamins, and herbal products. Message & data rates may apply. In hypertriglyceridemic patients, endogenous plasma concentrations of EPA at steady state (trough levels) increased by 309% and 678% after oral administration of VASCEPA 2 and 4 g/day, respectively. Vascepa is used together with other medicines (such as statins) to reduce the risk of heart attack, stroke, and some types of heart problems that need hospitalization in adults. Vascepa contains ethyl esters of the omega-3 fatty acid obtained from fish oil.Although the exact way Vascepa works is still unknown, it is believed to work by lowering the amount of triglycerides that are made in the liver, and by increasing the amount of … Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Indication Vascepa is used to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated trigylcerides and at high risk for, or established, cardiovascular disease. Health Canada's federal regulatory role over drugs and health products; links to adverse reactions, advisories and recalls, legislation, compliance, enforcement, MedEffect, controlled substances, natural health, biotechnology, radiopharmaceutical and veterinary products, international activities, public consultations, reports, research and publications if you are allergic to fish or shellfish. The daily dose of VASCEPA is 4 g/day (taken as two capsules twice daily) or 2 g/day (taken as two capsules once daily or one capsule twice daily). VASCEPA prescription and dosage sizes information for physicians and healthcare professionals. Call your doctor for medical advice about side effects. Before you take Vascepa, tell your doctor if you have liver disease, diabetes, a thyroid disorder, pancreas problems, a bleeding or blood-clotting disorder, an allergy to fish or shellfish, or if you drink large quantities of alcohol. BEDMINSTER, N.J., … Pharmacology, adverse reactions, warnings and side effects. Vascepa is already approved as a preventive for people with extremely high triglyceride levels—500 … There's growing evidence that taking a very high dose of purified fish oil, delivered in a prescription pill, can help prevent heart attacks … The main differences between Vascepa and fish oil is that Vascepa only contains eicosapentaenoic acid (EPA), whereas supplemental fish oils contain both EPA and docosahexaenoic acid (DHA). Medically reviewed by Sophia Entringer, PharmD. We comply with the HONcode standard for trustworthy health information -, Drug class: miscellaneous antihyperlipidemic agents. Member has been adherent for at least the last 4 months to maximally tolerated doses of one of the following statin regimens (i, ii, or iii): i. TORONTO, ON, Dec. 14, 2020 /PRNewswire/ -- The results of a Canadian study released this weekend provides encouraging data suggesting that the prescription strength omega-3 called icosapent ethyl (VASCEPA) may reduce inflammation and improve symptoms in patients with a diagnosis of COVID-19. Possible allergic reactions if you are allergic to fish or shellfish. 2009 Health Canada fact sheet. doses of VASCEPA. Not all possible drug interactions are listed here. Praluent, simvastatin, Xarelto, fenofibrate, rosuvastatin, Crestor, ramipril, Trulicity, Victoza, Brilinta. 744 eingeschriebene Teilnehmer. 3. Vascepa (icosapent ethyl) is the first FDA-approved drug to reduce cardiovascular risk among adults with elevated triglyceride (≥150 mg/dL) levels as an add-on to maximally-tolerated statin therapy. Do not break open, crush, dissolve, or chew VASCEPA. TORONTO, ON, Dec. 14, 2020 /PRNewswire/ -- The results of a Canadian study released this weekend provides encouraging data suggesting that the prescription strength omega-3 called icosapent By registering at this site, you certify that you reside in the United States and are at least 18 years of age. Vascepa will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan. If it is near the time of the next dose, skip the missed dose. VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy … There are no documented reports that Vascepa (icosapent ethyl) helps with weight loss. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or. Contact: Office of Submissions and Intellectual Property (OSIP ) What is a DIN?. -As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia. Vascepa is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Do not take two doses at one time. All trademarks are owned by their respective companies. You may report side effects to FDA at 1-800-FDA-1088. 3.2 Administration Patients should be advised to swallow VASCEPA capsules whole. This website, vascepa.com, vascepahcp.com, vascepasavings.com, truetoyourheart.com, and the corporation's website (amarincorp.com), are the only company-sanctioned websites pertaining to the Amarin group of companies or its product, VASCEPA ® (icosapent ethyl) capsules. LATE BREAKER - Primary Results of VASCEPA COVID-19 CardioLink-9 randomized trial Saturday, December 12 4:30 - 5:15pm First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial Guidelines can increase in families making up to $100,000 per year. Vascepa is only part of a treatment program that may also include diet, exercise, and weight control. This is not a complete list of side effects and others may occur. Households with a combined income of up to $50,000 per year. Continue reading. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA. Tell your doctor if you are pregnant or plan to become pregnant. Importantly, the VASCEPA 4 gram per day dose in EDPC003R01 appeared to be well-tolerated with a safety profile similar to placebo. Dosage Form Usual Dose Annual Cost of Therapy Icosapent ethyl (Vascepa) Under Review . Copyright 1996-2021 Cerner Multum, Inc. Vascepa Dosage & Precautions Before taking icosapent ethyl, tell your doctor or pharmacist if you are allergic to it; or to fish or shellfish products; or if you have any other allergies. • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. Y esperamos que Latina well with that to stay on time, I should end and I want to thank you for your attention. Medscape - Hypertriglyceridemia dosing for Vascepa (icosapent), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & … A high intensity statin (see Appendix D); ii. Follow all directions on your prescription label and read all medication guides or instruction sheets. But the data is murkier. Canada commercial launch of VASCEPA initiated (just prior to slowdown from COVID-19) Canada reimbursement levels for VASCEPA established within six months of product regulatory approval to facilitate treating patients with established cardiovascular disease ; ROW outlook includes: Large at-risk patient opportunities . Store at room temperature away from moisture and heat. An individual earning up to or around $30,000 per year. Pro Land gab es im Mittel nur ca. along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease. 4 g/d. Patients should be advised to swallow VASCEPA capsules whole. LATE BREAKER - Primary Results of VASCEPA COVID-19 CardioLink-9 randomized trial Saturday, December 12 4:30 - 5:15pm First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial persistent over several months. Vascepa reduces triglyceride production in the liver and enhances the clearance of triglycerides from lipid particles, via a number of different mechanisms. Vascepa contains icosapent ethyl and other ingredients. It is not known if you will have allergies to Vascepa as well. Continue reading, Hair thinning or loss (alopecia) is not listed as a side effect in data reviewed by the FDA for the approval of Vascepa. The daily dose of VASCEPA is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as; two 1 gram capsules twice daily with food. chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath. The information you provide will only be used by Amarin Pharma, Inc. and parties acting on its behalf to send you the materials you requested and other helpful information and updates on VASCEPA for heart health, as well as related information and services. a. Vascepa is prescribed in conjunction with a statin at the maximally tolerated dose; b. Advise patients to swallow VASCEPA capsules whole. 3.2 Administration Patients should be advised to swallow VASCEPA capsules whole. Vascepa is usually taken 2 times per day. Vascepa (icosapent) works in the liver and bloodstream to reduce very low-density triglycerides. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. This site uses cookies to give you the best possible experience. To ensure you get the full benefit of VASCEPA, it’s important to follow these dosing guidelines: For the standard size, take two 1-gram capsules twice a day with food. Vascepa is usually taken 2 times per day. This list is not complete. A bottle of 45 pills costs about $30, and users would take four pills a day. Do not take this medication if you are allergic to any of the ingredients. Available in 1000 mg. Cheap Vascepa from DrugMartDirect.com - CIPA & PharmacyChecker.com approved. En el en Canadá. Swallow the capsule whole and do not crush, chew, break, or open it. Use the medicine exactly as directed. To make sure Vascepa is safe for you, tell your doctor if you have ever had: a bleeding or blood-clotting disorder; or. The patient group assigned to 4 grams per day of VASCEPA showed a statistically significant median TG decrease of 19.9% (p<0.001) compared to placebo at the end of the 12-week treatment period. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in VASCEPA. Version: 3.01. Talk to your doctor prior to taking Vascepa if you have allergies to fish or shellfish. 3.3 Missed Dose If a dose is missed, patients should take it as soon as they remember. VASCEPA is not yet approved and available in any other countries. Uses: Patients randomized to the non-active arm received usual care. Vascepa is a prescription fish oil derivative that says it reduces the likelihood of heart disease by 26 percent. The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day VASCEPA dose group. Any weight loss is more likely to be due to diet modification and increased physical activity which are both recommended when taking Vascepa. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. With the Vascepa prescription savings card, commercially insured patients pay as little as $9 for a 90-day supply. Welcome to the Vascepa Savings Program please click below. Do not break open, crush, dissolve, or chew VASCEPA. It’s really a pleasure speaking to all of you. Talk to your pharmacist for more details. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Brand Name: Vascepa. Vascepa In Canada. Yes, Vascepa does thin your blood, and people receiving Vascepa are at a slightly increased risk of bleeding with one trial showing 12% of people receiving Vascepa experienced a bleeding event compared with 10% of people receiving a placebo (an inactive pill). Vascepa is not approved for use by anyone younger than 18 years old. Get emergency medical help if you have signs of an allergic reaction to Vascepa: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Comments: Find everything you need to know about Vascepa (Icosapent), including what it is used for, warnings, reviews, side effects, and interactions. Patients taking VASCEPA in combination with a statin have the option of taking two 1-g capsules or four 0.5-g capsules BID with food. It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis).It is not known if VASCEPA is safe and effective in children. "Importantly, the VASCEPA 4 gram per day dose in EDPC003R01 appeared to be well-tolerated with a safety profile similar to placebo. Y dentro de muy poco esperamos que se pruebe en Europa. In clinical testing conducted during the REDUCE-IT® trial, patients took the FDA-approved 4-gram dose (four 1-gram capsules, or eight 0.5-gram capsules) each day to achieve 25% added heart protection on top of statins. See TNT trial. Patients in the Vascepa arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Heart rhythm problems (atrial fibrillation and atrial flutter). VASCEPA becomes the first and only Health Canada approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in the studied high-risk patients. If you require further information and/or do not wish to have cookies placed when using the site, visit the Privacy Policy page. We will protect your privacy in accordance with our Privacy Policy. Generic Name: icosapent (eye KOE sa pent) There were no … Anecdotally, some blogs report weight loss with Vascepa, but this tends to correlate with the person experiencing side effects such excessive diarrhea or gastrointestinal discomfort. Avoid eating foods that are high in fat or cholesterol. Yes ; For more information about the CDR’s review of icosapent ethyl (Vascepa), you can . Vascepa® Granted Priority Review Status from Health Canada New Drug Submission (NDS) for Vascepa in Canada Anticipated to Be Filed in April 2019 by … VASCEPA, REDUCE-IT, Amarin and Vascepa/Amarin logos are registered trademarks of the Amarin group of companies. However, if you don't remember until the next day, don't take a double dose to make up for the one you missed. New Drug Submission (NDS) for Vascepa in Canada Anticipated to Be Filed in April 2019 by HLS Therapeutics, Under Agreement with Amarin. Was ist eine fettarme Diät? Register for the VASCEPA Savings Program by entering your mobile number below or texting VASCEPA to 26789. Y también muy pronto se aprobará en la China. Take your next dose at the regular time. Order Vascepa (Icosapent Ethyl) from Canada, at lower prices to the U.S. Text STOP to end.Terms and Conditions. Laboratory results showed that Vascepa reduced triglycerides by a median of -39 mg/dL (or a drop of 18%) after one year whereas those assigned to placebo had an increase in triglycerides of 5 mg/dL (an increase of 2%). VASCEPA capsules are supplied as: New Drug Submission (NDS) for Vascepa in Canada Anticipated to Be Filed in April 2019 by HLS Therapeutics, Under Agreement with Amarin. Call 1-877-900-3784 to buy Vascepa from CanadaDrugsOnline.com, a certified online pharmacy from Canada with lowest prices on Vascepa (Icosapent Ethyl). Cholesterol Absorption Inhibitor Ezetimibe (Ezetrol and generics) You should not use Vascepa if you are allergic to icosapent. Vascepa is only part of a complete treatment program that may also include diet, exercise, and weight control. There was also the ... High dose statins is standard of care in this population with sub 70 LDL targets and Vascepa added to target TG sub 150 ideally. Icosapent can pass into breast milk, and may harm your baby. Keep in mind, if our advocates cannot obtain your Vascepa medication for you, we will never charge a fee for that medication. PrescriptionPoint.com proudly displays its CIPA (Canadian International Pharmacy Association) seal, as well as the Pharmacy Checker seal to signal that we conform to nothing but the highest standards for quality.
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