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Methods: Irbesartan is an appropriate substitution for valsartan or losartan. 0000013515 00000 n
In the first study, olmesartan 10 mg/d was compared with losartan 50 mg/d in 316 patients with mild to moderate hypertension (mean baseline diastolic blood pressure [DBP], 95-114 mm Hg). FDA has posted a list of currently available ARBs and the status of our assessment of those medications. Lowers blood pressure. By using this Site you agree to the following, By using this Site you agree to the following. Be certain to check samples to ensure affected products are not given to patients. We are still seeking to similarly quantify the risk to patients from NDEA and will communicate our findings as soon as possible. Olmesartan is the newest member of this class. Since there are many manufacturers of valsartan and sources can vary whenever a patient refills a prescription, it is very likely that a patient using valsartan for four years would not have always received one of the relatively few affected medicines that contained these impurities. and transmitted securely. - Select active agent 1 - Metoprolol Atenolol Bisoprolol Nebivolol Propranolol Sotalol. Lowers the risk of heart attack and stroke. Prescription only Would you like email updates of new search results? National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. 0000002653 00000 n
Samples can also be affected and part of the recall. Chornobyl NPP; NPP; Spent Nuclear Fuel Management Before we undertook this analysis, neither regulators nor industry fully understood how the nitrosamines could form during the manufacturing process. MeSH These results show that the differences in angiotensin II receptor blockade observed with the various AT(1) antagonists are explained mainly by differences in dosing. Unable to load your collection due to an error, Unable to load your delegates due to an error. Valsartan, losartan, irbesartan and other -sartan drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure. Please enable it to take advantage of the complete set of features! 0000002424 00000 n
Convenient. Measurements were obtained before and 4 and 24 hours after drug intake on days 1 and 8. Where do I find the manufacturer or repackager name and National Drug Code (NDC) of my medication? The angiotensin II receptor blockade was assessed with two techniques, the reactive rise in plasma renin activity and an in vitro radioreceptor binding assay that quantified the displacement of angiotensin II by the blocking agents. Following is an example of an ARB medication label to help you identify the information on your medication: Note the manufacturer may be different from the distributor or labeler of your medication. 3.7 / 5 average rating with 535 reviews forLosartan Upsides The pharmacological potency of various AT(1) antagonists assessed by Schild regression technique in man. Bookshelf International Union of Basic and Clinical Pharmacology. Losartan works on a hormone called angiotensin II to lower blood pressure and may also improve kidney function in some These data indicate that, at the doses studied, olmesartan is more effective than other AIIRAs tested at their recommended doses, in terms of reduction of cuff or 24-hour ambulatory blood pressure, in patients with essential hypertension. Disclaimer, National Library of Medicine 0000001940 00000 n
1999 Oct;66(4):367-73. doi: 10.1053/cp.1999.v66.a101162. Lists of ARB medicines affected by the recall are available on FDAs website for healthcare professionals and patients to monitor. Bethesda, MD 20894, Web Policies Angiotensin II receptor blockade in normotensive subjects: A direct comparison of three AT1 receptor antagonists. FOIA Do Not Copy, Distribute or otherwise Disseminate without express permission. XCIX. The site is secure. Titrate dose to 80 to 160 mg twice daily, as tolerated. Maximum daily dose: 320 mg. Left ventricular dysfunction after MI: Initial: 20 mg twice daily. Circulation. FDA has also posted a list of ARBs that are currently available, along with information regarding the status of FDAs assessment for those medications. sharing sensitive information, make sure youre on a federal In addition to the above, there are some less commonly used ACEi that are listed here with their dose equivalence: Fosinopril: 10mg Drug Comparisons - Home Page. The .gov means its official. This site needs JavaScript to work properly. Bethesda, MD 20894, Web Policies Drug Des Devel Ther. Manufacturers are required to test for impurities that may be introduced or developed during their manufacturing processes. Irbesartan (Avapro) $10 Diabetic nephropathy: 300mg/day Hypertension: 150-300mg/day Initial dose of 75mg once daily recommended for volume/sodium-depleted patients Losartan Objective: Prescription only. This website was made to assist in clinical knowledge recall and to supplement and support clinician judgement. Before Publication types Clinical Trial Irbesartan (Avapro) Losartan (Cozaar) Olmesartan (Benicar) Dosing of ACE-Inhibitors and ARBs . Careers. Diovan [package insert]. eCollection 2021. Careers. Cuff and ambulatory blood pressures were monitored at baseline and after 8 weeks of treatment. 0000004152 00000 n
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Please enable it to take advantage of the complete set of features! St. Louis, MO. AAPS PharmSciTech. The present article reviews 3 head-to-head trials directly comparing the antihypertensive efficacy of olmesartan with that of 4 other AIIRAs, at recommended maintenance doses, already in clinical use for the treatment of hypertension. Irbesartan To Losartan Conversion Buy Coupons What Cooking Oils Lower Blood Pressure I C Amlodipine Easy Foods That Help Lower Blood Pressure Chinese High Blood Pressure Medicine Irbesartan To Losartan Conversion.. Hey, thank you brother, After attracting attention with valsartan 160 12 5 the guests, Noconnor coughed and said, I need to recruit a what to do Rapid detection of the known SNPs of CYP2C9 using oligonucleotide microarray. Irbesartan (Avapro ) Supplied: 75 mg, 150 mg, 300 mg Dosing : Hypertension: Oral: 150 mg once daily patients may be titrated to 300 mg once daily. Note: Starting dose in volume-depleted patients should be 75 mg. Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Cozaar [package insert]. It's not safe to use Avapro (irbesartan) if you're pregnant. Valsartan, losartan, irbesartan and other -sartan drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure. Antihypertensive effects of olmesartan compared with other angiotensin receptor blockers: a meta-analysis. Before 0000001505 00000 n
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J Renin Angiotensin Aldosterone Syst. Switching from lisinopril to losartan may help reduce the likelihood of developing a dry cough. Most of this treatment effect was evident after only 1 or 2 weeks, with greater reductions in blood pressure compared with candesartan. The number of subjects achieving their goal blood pressure at each assessment visit was similar: 37.5% at baseline, 43.4% at 2 weeks, and 31.9% at 2 months. J Renal Inj Prev. 2009;10(4):1200-5. doi: 10.1208/s12249-009-9318-y. Weeda ER, Nguyen E, Martin S, Ingham M, Sobieraj DM, Bookhart BK, Coleman CI. NCI CPTC Antibody Characterization Program. East Hanover, NJ: Novartis Pharmaceutical Co; June 2007. 0000079040 00000 n
This site needs JavaScript to work properly. Product development studies on surface-adsorbed nanoemulsion of olmesartan medoxomil as a capsular dosage form. Report any unexpected side effects with ARB-containing medicines, to FDAs MedWatch program to help the agency better understand the scope of the problem: We are working with manufacturers to recall medicines with nitrosamine impurities above the interim acceptable intake levels that present an unnecessary risk to patients. Operating NPPs. The .gov means its official.Federal government websites often end in .gov or .mil. NUCLEAR INDUSTRY. Role of olmesartan in combination therapy in blood pressure control and vascular function. New York, NY: Sanofi-Synthelabo; October 2005. HHS Vulnerability Disclosure, Help In a second study, olmesartan 20 mg/d was shown to be significantly more effective than losartan 50 mg/d, valsartan 80 mg/d, and irbesartan 150 mg/d in 588 patients with mild to moderate hypertension (mean sitting baseline DBP, 100-115 mm Hg) (P < or = 0.05). Of these, 588 patients entered the treatment phase of the study and were randomized to olmesartan (n=147), losartan (n=150), valsartan (n=145), or irbesartan (n=146). Equivalent dosing of irbesartan, valsartan, and losartan identified through formulary switch at a Veterans Affairs medical center. These guidelines suggested that patients taking irbesartan 150 mg once daily be treated with either valsartan 80 mg or losartan 50 mg once daily and that patients taking irbesartan 300 mg once daily be treated with Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drugs API, and may also result from the reuse of materials, such as solvents. Please enable it to take advantage of the complete set of features! ESC Heart Fail. Dosage was doubled at week 4 and hydrochlorothiazide was added at week 12 if blood pressure response was inadequate. Epub 2018 Jan 17. Download and complete the appropriate form, then submit it via fax at. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Atacand [package insert]. Disclaimer, National Library of Medicine Calculation of equivalent doses of antihypertensive drugs. 0000029477 00000 n
Equivalent to Lisinopril 10mg Captopril 25mg BID Enalapril 10mg Ramipril 2.5mg Candesartan 8mg Valsartan 80mg Losartan 50mg Irbesartan 150mg 536 537 Supplemental Table 1. Downsides: Losartan is taken once daily, though at lower strengths it doesnt provide great 24-hour coverage. Il propose des spectacles sur des thmes divers : le vih sida, la culture scientifique, lastronomie, la tradition orale du Languedoc et les corbires, lalchimie et la sorcellerie, la viticulture, la chanson franaise, le cirque, les saltimbanques, la rue, lart campanaire, lart nouveau. Protects kidney function, which is especially useful for people with diabetes or mild-to-moderate kidney disease. Time course and extent of angiotensin II antagonism after irbesartan, losartan, and valsartan in humans assessed by angiotensin II dose response and radioligand receptor assay. Angiotensin Receptor Blockers Recommended Dose Conversions Valsartan Irbesartan Losartan Olmesartan Telmisartan Candesartan Azilsartan Eprosartan A Cozaar (Losartan) is a good blood pressure-lowering medicine that protects kidney function like an ACE inhibitor, but with fewer side effects. In Hypertension: Consider switching patient to either losartan or candesartan in the first instance. 0000029499 00000 n
2019 Oct 19;7(1):1678563. doi: 10.1080/20016689.2019.1678563. The https:// ensures that you are connecting to the A retrospective review of medical records for subjects whose antihypertensive was converted to irbesartan was conducted. 0000012313 00000 n
Irbesartan 150mg Telmisartan 80mg 40-80mg 40mg ~80mg Valsartan 160mg 80mg Note: There are variations for approximate equivalent dosages between ACEIs and ARBs in clinical trials. Results: In the first study, olmesartan 10 mg/d was compared with losartan 50 mg/d in 316 patients with mild to moderate hypertension (mean baseline diastolic blood pressure [DBP], 95-114 mm Hg). Vasc Health Risk Manag. Wilmington, DE: AstraZeneca; February 2007. 2009 May;63(5):766-75. doi: 10.1111/j.1742-1241.2009.02028.x. An official website of the United States government. zYPRc%+5~_U%);omW0^
#
D2BH|~3 dpn"I#7)+4}]5vi=eI_oud 8600 Rockville Pike Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that dont meet the agencys safety standards. Mancia G, Korlipara K, van Rossum P, Villa G, Silvert B. Conversion was attempted in 79 subjects; 72 met the criteria for review. Copyright 2021 GlobalRPH - Web Development by, HONcode standard for trust- worthy health, Pediatric Oncology: Diagnosis And Prognosis Communication. 300 mg orally once a day. 0000001147 00000 n
World J Gastroenterol. At 4 and 24 hours, valsartan induced a dose-dependent "blockade" of AT(1) receptors. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. Mean baseline, 2-week, and 2-month blood pressures for all subjects were 143/74, 139/72, and 139/73 mm Hg, respectively (p values NS). Equivalent dosages are provided by Bookshelf HWK6WRZ@\Mp6+E=l~gHp[Pk47kI?$UDy5yR?%f/n< For those patients who were to continue ARB therapy via a switch to Similar to ACE inhibitors (like Lisinopril), with fewer side effects like cough and swelling. Thirteen of the 72 subjects discontinued irbesartan due to adverse events. Conclusions: Clipboard, Search History, and several other advanced features are temporarily unavailable. MeSH Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens (a substance that could cause cancer), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen. Valsartan vs. other angiotensin II receptor blockers in the treatment of hypertension: a meta-analytical approach. It works similar to ACE inhibitors (like lisinopril), but it doesn't have the same side effects like coughing and facial swelling. Pharmacol Rev. Comparative efficacy of irbesartan/ hydrochlorothiazide and valsartan/hydrochlorothiazide combination in lowering blood pressure: a retrospective observational study in Oman. In this study we Olmesartan medoxomil for the treatment of hypertension in children and adolescents. Curr Hypertens Rev. At trough, however, the valsartan-induced blockade was slightly less than that obtained with irbesartan. (Pro)renin Receptor and Blood Pressure Regulation: A Focus on the Central Nervous System. Please send us questions or comments by email to druginfo@FDA.hhs.gov or by phone to 855-543-3784. Why are some valsartan, losartan, and irbesartan medicines being recalled? Ezetimibe was found to have a 50%inhibition conc of 25micromolar, while irbesartan, a commonly used angiotensin inhibitor to reduce blood pressure, was found to inhibit at 11.9 Objective: To determine whether subjects whose therapy was converted from losartan or valsartan to irbesartan maintained equivalent blood pressure measurements, sharing sensitive information, make sure youre on a federal 2012 Oct 1;12(5):335-44. doi: 10.1007/BF03261842. Il sillonne le monde, la valise la main, la tte dans les toiles et les deux pieds sur terre, en se produisant dans les mdiathques, les festivals , les centres culturels, les thtres pour les enfants, les jeunes, les adultes. 2022;18(2):101-116. doi: 10.2174/1570162X20666220127105655. Diabetic kidney disease; review of the current knowledge. Accessibility Losartan 25 mg or 50 mg once daily may not give you full coverage throughout the day and night. 0000005532 00000 n
Morrisville, NC: Biovail Pharmaceuticals; September 2005. Get current information about recalls of blood pressure medications. An Open Label Trial to Assess Safety of Losartan for Treating Worsening Respiratory Illness in COVID-19. telmisartan to losartan conversion Depending on what valsartan or irbesartan dose, select an equivalent dose of You will be asked to perform emergent and urgent echocardiograms while on-call. Yes. Most patients who were exposed to the impurity through the use of affected valsartan received less exposure than in the scenario described above. 0000006557 00000 n
Patients and health care professionals should report any unexpected adverse event with ARB-containing products to the FDAs MedWatch program to help the agency better understand the scope of the problem: An official website of the United States government, : Why didnt FDA identify the risk of these impurities earlier? Int J Clin Pract. 2001 Feb 13;103(6):904-12. doi: 10.1161/01.cir.103.6.904. We are also working with makers of API to ensure they remediate their manufacturing processes and their API does not contain these impurities. Comparison of Oral ACE inhibitors. Pharmacists Letter/ Prescribers Letter, irbesartan may also be used for purposes not listed in this medication guide. 2002 Apr;7(2):135-42. doi: 10.1097/00126097-200204000-00008. HHS Vulnerability Disclosure, Help Bengtson CD, Montgomery RN, Nazir U, Satterwhite L, Kim MD, Bahr NC, Castro M, Baumlin N, Salathe M. Front Med (Lausanne). Abstract. Methods: Chung WB, Ihm SH, Jang SW, Her SH, Park CS, Lee JM, Chang K, Jeon DS, Yoo KD, Seung KB. Unable to load your collection due to an error, Unable to load your delegates due to an error. Disclaimer, National Library of Medicine `#3)>dTgX\:H
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:']5"hs mqF&$X yT`wI8h Note: Starting dose in When 160-mg or 320-mg doses were investigated, the effects of valsartan hardly differed from those obtained with recommended doses of irbesartan and candesartan. Description. Losartan (Cozaar ) Supplied: 25 mg, 50 mg, 100 mg Dosing : Hypertension: Oral: Initial: 25 to 50 mg once daily. Can be administered once or twice daily with total daily doses ranging from 25 to 100 mg. Usual initial doses in patients receiving diuretics or those with intravascular volume depletion: 25 mg. Candesartan (Atacand ): 8 mg, Eprosartan (Tevetan ): 400 mg, This site needs JavaScript to work properly. In other words, it needs to be recognized that there is a risk of an impurity occurring to know that it should be tested for. Disclaimer: Starting doses and titration schedule depend on individual clinical scenario and are particularly important to review with renal failure that may have different starting dose recommendations*. All doses were given once daily for 8 days. Ridgefield, CT: Boehringer Ingelheim; November 2003. 0000003103 00000 n
Bookshelf Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled. Oparil S, Williams D, Chrysant SG, Marbury TC, Neutel J. J Clin Hypertens (Greenwich). 2009 May;63(5):766-75. doi: 10.1111/j.1742-1241.2009.02028.x. NDMA was the first impurity discovered, and FDA pharmacologists, toxicologists and chemists have taken measures to assess its risk. Objectives: We have reported previously that 80 mg valsartan and 50 mg losartan provide less receptor blockade than 150 mg irbesartan in normotensive subjects. Diovan to losartan conversion chart. 80-320 mg daily ARBs 80 or 160 mg daily Valsartan (Diovan) References: 1. Zaporizhzhya NPP; Rivne NPP; Khmelnytsky NPP; South-Ukraine NPP; Decommissioning. CrCl < 10 mL/minute: use in adults has not been studied; use with caution. trailer
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FDA has determined the recalled ARBs pose an unnecessary risk to patients. You'll need to get yearly blood tests while taking Avapro (irbesartan) to see how it is affecting your body. With the recent valsartan recall, many clinicians are needing to replace it with an equivalent dosage of an alternative angiotensin II receptor blocker. The .gov means its official. Epub 2012 Sep 11. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Accessibility and transmitted securely. Tablet powder equivalent to 50 mg of valsartans API was weighted in a glass tube. Cozaar (Losartan) is a good blood pressure-lowering medicine that protects kidney function like an ACE inhibitor, but with fewer side effects. Compared with other antagonists, 80 mg valsartan and 50 mg losartan had a comparable profile. 2005;5(1):41-50. doi: 10.2165/00129784-200505010-00006. The 160-mg and 320-mg doses of valsartan blocked AT(1) receptors at 4 hours by 80%, which was similar to the effect of 150 mg irbesartan. Ocotober 2006. We also inspect manufacturing facilities around the world, and in routine current good manufacturing practices inspections we can review a manufacturers records regarding impurity testing. Epub 2011 Mar 31. Ratio spectra derivative and zero-crossing difference spectrophotometric determination of olmesartan medoxomil and hydrochlorothiazide in combined pharmaceutical dosage form. 2018 Apr;5(2):354-363. doi: 10.1002/ehf2.12249. Losartan is made as a stand-alone drug, and in a combination tablet with the diuretic, hydrochlorothiazide (HCTZ), as losartan/HCTZ. Demographic data were collected, and subjects' past medical histories were used to determine their goal blood pressure. These differences in blood pressure reduction between these agents may be clinically relevant and have important long-term implications. Claude Delsol, conteur magicien des mots et des objets, est un professionnel du spectacle vivant, un homme de paroles, un crateur, un concepteur dvnements, un conseiller artistique, un auteur, un partenaire, un citoyen du monde. 0000001526 00000 n
The pharmacist may be able to provide you with an unaffected ARB made by another company. Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here. [tdc_zone type=tdc_content][vc_row][vc_column][td_block_trending_now limit=3][/vc_column][/vc_row][vc_row tdc_css=eyJhbGwiOnsiYm9yZGVyLXRvcC13aWR0aCI6IjEiLCJib3JkZXItY29sb3IiOiIjZTZlNmU2In19][vc_column width=2/3][td_block_slide sort=featured limit=3][td_block_2 border_top=no_border_top category_id= limit=6 td_ajax_filter_type=td_category_ids_filter ajax_pagination=next_prev sort=random_posts custom_title=SEA MOSS RECIPES][td_block_1 border_top=no_border_top category_id= sort=random_posts custom_title=SEA MOSS BEAUTY][td_block_ad_box spot_id=custom_ad_1][td_block_15 category_id= limit=8 sort=random_posts custom_title=SEA MOSS HEALTH BENEFITS][/vc_column][vc_column width=1/3][td_block_social_counter custom_title=STAY CONNECTED facebook=tagDiv twitter=tagdivofficial youtube=tagdiv border_top=no_border_top][td_block_9 custom_title=LIFESTYLE border_top=no_border_top category_id= ajax_pagination=next_prev sort=random_posts][td_block_ad_box spot_id=sidebar][td_block_2 sort=random_posts limit=3 category_id= custom_title=SEA MOSS BUSINESS][td_block_title][td_block_10 limit=3 custom_title= border_top=no_border_top tdc_css=eyJhbGwiOnsibWFyZ2luLXRvcCI6Ii0yMCJ9fQ==][/vc_column][/vc_row][/tdc_zone], Designed by Elegant Themes | Powered by WordPress. 0000012291 00000 n
eCollection 2020. Should I continue taking my medication even if it has been recalled? Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. The site is secure. Avapro (irbesartan) is a good blood pressure-lowering medicine that protects your kidneys and has few side effects. official website and that any information you provide is encrypted HHS Vulnerability Disclosure, Help FDA suggests health care professionals check the lists regularly for updates. Drug Facts & Comparisons. 0000005511 00000 n
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GrepMed and the images sourced through this website are NOT a substitute for clinical judgement. The presence of these nitrosamine impurities in ARB medicines was unexpected. Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option. ^)_cpu
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2015 Oct;67(4):754-819. doi: 10.1124/pr.114.010454. 2020 Jan 23;14:347-360. doi: 10.2147/DDDT.S231293. 2011 Mar;57(3):413-20. doi: 10.1161/HYPERTENSIONAHA.110.163402. It will also be printed on the back of a blister pack. Facts & Comparisons. Switching Between The Two Drugs Before switching back to lisinopril, it may help to The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 2013 Jun 1;2(2):73-80. doi: 10.12861/jrip.2013.24. David McAuley, Pharm.D. Copyright 1993-2021 2000 Dec;1(4):336-41. doi: 10.3317/jraas.2000.063. Federal government websites often end in .gov or .mil. -Blocker. 0000079118 00000 n
Epub 2011 Jan 31. The site is secure. Objectives: Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Before sharing sensitive information, make sure you're on a federal government site. Available in generic, and available with hydrochlorothiazide as a combination tablet. The https:// ensures that you are connecting to the The most common reasons for discontinuation prior to randomization were failure to meet the blood pressure entry criteria (70%) and patient request (9%). Hb```f`` @Qk)(#SUfUl I@@X*@eg,azW q#PESAEWA k#O2] mL// @s1A b [&
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