22 (9%) PubMed, However, the mean plasma clearance of ondansetron was reduced by about 50% in patients with severe renal impairment (creatinine clearance less than 30 mL/min). prevention of nausea and vomiting associated with radiotherapy Vhody smoothies zvisia od toho, o do nich dte. Conclusions: Age: Geriatric Population: A reduction in clearance and increase in elimination half-life are seen in patients older than 75 years compared to younger subjects [see USE IN SPECIFIC POPULATIONS (8.5)]. The first images of the 'middle aged' Love Island programme hosted by Davina McCall have been released ahead of the show's launch. Alcohol Clin Exp Res. Presence in Breast Milk, Medline Plus, Several ondansetron interactions are related to its effect on serotonin. EOA-associated improvements in mood disturbance seemed to be independent of drinking behavior. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Disintegrating Tablets Hepatobiliary: Liver enzyme abnormalities, Neurology: Oculogyric crisis, appearing alone, as well as with other dystonic reactions. No dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe). Additional information on the use of ondansetron in pediatric patients may be found in ondansetron Injection prescribing information. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group, completed the 24-hour trial period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure. In a pharmacokinetic study of 16 epileptic patients maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin, reduction in AUC, Cmax, and T of ondansetron was observed.1 This resulted in a significant increase in clearance. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prolongation have been reported. Ondansetron has been shown to be an effective treatment for early-onset alcoholism. In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation. 7.2 Drugs Affecting Cytochrome P-450 Enzymes. The use ofondansetron in patients followingabdominal surgery or in patientswith chemotherapy-induced nauseaandvomiting may mask a progressive ileus and/or gastric distension. There is no experience beyond first-day administration of ondansetron. Cardiac Electrophysiology 34 (6%) 1 (<1%) Dosage Adjustment for Patients With Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control. In an active-controlled, double-blind trial in 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of greater than or equal to 100 cm2 to the abdomen, ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes). Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. The following have been reported as adverse events in clinical trials of patients treated with ondansetron. These Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8 mg Twice Daily Treatment response was based on the total number of emetic episodes over the 3-day trial period. 8mg The background risk of major birth defects and miscarriage for the indicated population is unknown. WebThe study uses data from the FDA. Ondansetron tablets (16 mg) were significantly more effective than placebo in preventing postoperative nausea and vomiting. Chemically it is ()1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. Patients received the first dose of ondansetron tablets (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the patient received the first daily radiotherapy fraction, with 2 subsequent doses on a 3 times a day basis. Patients should be instructed not to remove ondansetron orally disintegrating tablets from the blisteruntil just prior to dosing. 6 (2%) Un programa que dej de tener gracia Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. Children 4 to 11 years of ageAt first, 4 mg taken 30 minutes before starting cancer treatment. Saddle Brook, NJ 07663, Advanced Rx Pharmacy of Tennessee LLC, Nashville, TN 37211 Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el prximo viernes 23 de junio. Patients continued the doses of oral medication three times daily for 3 days. In these studies, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on day 1. Rising Health, LLC Circulating drug also distributes into erythrocytes. Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. 49 (9%) More detailed pharmacokinetic information is contained in Tables 1 and 2 taken from 2 studies. Chemotherapy-Induced Nausea and Vomiting: The adverse events in Table 5 have been reported in 5% of adult patients receiving a single 24 mg ondansetron tablet in 2 trials. ISS. Package leaflet: Information for the user. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation [see CLINICAL PHARMACOLOGY (12.2)]. and transmitted securely. Unauthorized use of these marks is strictly prohibited. If radiotherapy was given in the morning, 2 additional doses of study treatment were given (1 tablet late afternoon and 1 tablet before bedtime). WebAnti-Anxiety Agents / adverse effects Anti-Anxiety Agents / therapeutic use* Anxiety Disorders / diagnosis Moderately Emetogenic Cancer Chemotherapy (n = 262) ondansetron HCl 4 mg/5 mL Revised: 06/2021, Set id: af836a30-5e51-5c97-e053-2995a90a15b9, ondansetron tablet, orally disintegrating, Ondansetron Orally Disintegrating Tablets, Median time to first emetic episode (hours), 30 in 1 BOTTLE; Type 0: Not a Combination Product, 20 in 1 BOTTLE; Type 0: Not a Combination Product. To help you remember, take it at the same times each day. Ondansetron is a selective 5-HT3 receptor antagonist. For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. Pyrexia sharing sensitive information, make sure youre on a federal 4 mg Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Biochemical Data Summary. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) QTcF of 14.0 (16.3) milliseconds. Smoothie. Interactions with general or local anesthetics have not been studied. government site. Web4-mg. 8-mg. Count. Phenytoin, Carbamazepine, and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. No studies have been performed in males. If you are a consumer or patient please visit Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Oral administration of ondansetron up to 15 mg/kg/day did not affect fertility or general reproductive performanceof male and female rats. official website and that any information you provide is encrypted A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group, completed the 24-hour trial period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. There are, however, no adequate and well-controlled studies in pregnant women. In these foreign trials, the initial dose of ondansetron (ondansetron HCl) injection ranged from 0.04 to 0.87 mg/kg for a total dose of 2.16 mg to 12 mg. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group completed the 24-hour study period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. 1 tablet. The first 8 mg dose of ondansetron was administered 30 minutes before the start of chemotherapy, with a subsequent dose 8 hours after the first dose, followed by 8 mg of ondansetron twice a day for 2 days after the completion of chemotherapy. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. 2000 May;24(5):737-42. More than 90% of patients receiving a cisplatin dose 50 mg/m2 in the historical placebo comparator experienced vomiting in the absence of antiemetic therapy. Ondansetron Orally The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex. Serious side effects of ondansetron include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, Unable to load your collection due to an error, Unable to load your delegates due to an error. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs.1,3 Pruritus Overall, 65% of patients reported symptom relief with ondansetron, while only 14% getting the placebo reported relief. It is not known whether these gender-related differences were clinically important. 8mg Other drugs that have the same active ingredients (e.g. The most common adverse reactions reported in adults in trial(s) of prevention of postoperative nausea and vomiting are shown in Table 4. Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g., CYP2D6 genetic deficiency) will be compensated by others and may result in little change in overall rates of ondansetron elimination. The increases were transient and did not appear to be related to dose or duration of therapy. Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, PEEL BACK the Ondansetron orally disintegrating tablets, 4 mg (as 4 mg ondansetron base) are white to off white, oval, uncoated tablets debossed with 240 on one side, plain on the other side. Count. Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics). [see USP Controlled Room Temperature], Distributed by: Copy the URL below and paste it into your RSS Reader application. The premium product BATCH gummies is full-spectrum, vegan-friendly, and made with solely natural components. The first images of the 'middle aged' Love Island programme hosted by Davina McCall have been released ahead of the show's launch. In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. Geriatric Use: The dosage recommendation is the same as for the general population. Highly Emetogenic Cancer Chemotherapy Radiotherapy Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days. No dosage adjustment is needed in patients with mild or moderate hepatic impairment. Slower clearance in women, a smaller apparent volume of distribution (adjusted for weight), and higher absolute bioavailability resulted in higher plasma ondansetron concentrations. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE). Bioavailability is also slightly enhanced by the presence of food but unaffected by antacids. In the same trial, 56% of patients receiving a single 24 mg oral dose of ondansetron experienced no nausea during the 24-hour trial period, compared with 36% of patients in the oral ondansetron 8 mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32 mg once-a-day group. Bottle pack of 30 tablets with Child Resistant Cap (NDC 62756-356-83) Unit dose packs of 30 tablets (NDC 62756-356-64)Unit dose packs of 10 tablets (NDC 62756-356-66) What Ondansetron Syrup is and what it is used for 2. Dosage adjustment is not needed in patients over the age of 65 (see CLINICAL PHARMACOLOGY). Ondansetron was not mutagenic in standard tests for mutagenicity. Plasma protein binding of ondansetron as measured in vitro was 70% to 76% over the concentration range of 10 to 500 ng/mL. Masking of Progressive Ileus and Gastric Distension 32 (13%) Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively (see Data). La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el prximo viernes 23 de junio. Please enable it to take advantage of the complete set of features! Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Prevention of emesis in these pediatric patients was essentially the same as for adults. Placebo Photo: Andreas Neumann. Headache Methods: What Setofilm is and what it is used for. 10. Early-onset alcoholics (EOA) differ from late-onset alcoholics (LOA) by developing problem drinking during youth, experiencing severe behavioral problems, having a familial disease history, and possessing a tendency toward subsyndromal mood disturbance, including symptoms of depression, anxiety, and hostility. No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. A causal relationship to therapy with ondansetron was unclear in many cases. Food Effects: Bioavailability is also slightly enhanced by the presence of food. The safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for: prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy Ondansetron is a white to off-white powder. There is no specific antidote for ondansetron overdose. A retrospective cohort study of 1.8 million pregnancies in the U.S. Medicaid Database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (RR 1.24, 95% CI 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (RR 0.95, 95% CI 0.63, 1.43). Intranasal ondansetron microemulsion counteracting the adverse effects of cisplatin: animal study. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a J Clin Psychiatry. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)]. Malaise/fatigue BIN PCN Group Member ID. Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets: Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy: Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy: Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: For single high-dose fraction radiotherapy to the abdomen, For daily fractionated radiotherapy to the abdomen. National Library of Medicine He armed himself with a balaclava, latex gloves, condoms and Viagra pills and posed as a cab driver in a Mercedes to roam the streets of Brighton, East Sussex. Possible side effects 5. 34 (6%) FOIA CYP 3A4 Inducers: Ondansetron elimination may be affected by cytochrome P-450 inducers. Prevention of Chemotherapy-Induced Nausea and Vomiting Chemotherapeutic Agents: Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron [see DRUG INTERACTIONS (7.4)]. Pediatric Use: There is no experience with the use of ondansetron orally disintegrating tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients. Akbar M, Egli M, Cho YE, Song BJ, Noronha A. Pharmacol Ther. Hiccups. The most frequently reported adverse events were headache, constipation, and diarrhea. Serious side effects of ondansetron include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, anxiety, agitation, shivering, feeling like you might pass out, and urinating less than usual or Clipboard, Search History, and several other advanced features are temporarily unavailable. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). (current), ondansetron 4 MG Disintegrating Oral Tablet, ondansetron (as ondansetron HCl) 4 MG Disintegrating Oral Tablet, ondansetron 8 MG Disintegrating Oral Tablet, ondansetron (as ondansetron HCl) 8 MG Disintegrating Oral Tablet, Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen: The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day. 2002 Apr;160(4):408-13. doi: 10.1007/s00213-002-1002-9. Moderately Emetogenic Cancer Chemotherapy Steroid administration was excluded from these clinical trials. Bookshelf The dosage is the same as for the general population. The results of this study are summarized in Table 4: I n uncontrolled trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ondansetron tablets 8 mg 3 times daily during subsequent chemotherapy for a total of 396 re-treatment courses. If radiotherapy was given in the afternoon, patients took 8 mg of ondansetron or 10 mg of metoclopramide only once before bedtime. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. Other: Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. Patients continued the oral medication on a 3 times a day basis for 3 days. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron tablets. Urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. In a double-blind, U.S. trial in 336 patients receiving a cyclophosphamide-based chemotherapy regimen containing either methotrexate or doxorubicin, ondansetron 8 mg administered twice a day, was as effective as ondansetron 8 mg administered 3 times a day in preventing nausea and vomiting. Dizziness Ondansetron has no effect on plasma-prolactin concentrations. Therefore, the serotonin-3 antagonist ondansetron, which has been shown to be effective at improving drinking outcomes and promoting abstinence among EOA, presumably by ameliorating serotonin dysfunction, also may exert its beneficial effects by alleviating mood disturbance among EOA. The .gov means its official. Setofilm 4mg. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. ADVANZ Pharma Address "Vitamn C njdete v ovoc, ako s pomarane a jahody, a In clinical trials with cancer patients, safety and efficacy were similar in patients over 65 years of age and those under 65 years of age; there was an insufficient number of patients over 75 years of age to permit conclusions in that age-group. a Reported in greater than or equal to 5% of patients treated with ondansetron orally disintegrating tablets and at a rate that exceeded placebo. Serotonergic Drugs: Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) (see WARNINGS). PJPI0324B, NDC 62756-240-83 These patients were receiving multiple concomitant perioperative and postoperative medications. The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam. Ondansetron elimination may be affected by cytochrome P-450 inducers. Meets USP Disintegration Test 2. 27 (5%) Placebo In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Print patient leaflet in large text. Citations, Report Adverse In a crossover study with 25 subjects, headache was reported in 6 subjects administered ondansetron orally disintegrating tablets with water (24%) as compared with 2 subjects administered ondansetron orally disintegrating tablets without water (8%). Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs. Then administer 8 mg twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Vhody smoothies zvisia od toho, o do nich dte. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Ondansetron is a first-line antiemetic. If hypersensitivity reactions occur, discontinue use of ondansetron; treat promptly per standard of care and monitor until signs and symptoms resolve [see CONTRAINDICATIONS (4)]. In contrast, 16 mg infused intravenously over 15 minutes using the same model had a mean predicted (95% upper prediction interval) QTcF of 9.1 (11.2) milliseconds. It to take advantage of the 170 evaluable patients had a complete response ( no emetic episodes ) day... Been studied, or severe ) solely natural components the vomiting reflex only if clearly needed Vhody zvisia. La Operacin Deluxe tiene mucho -o todo- que ver con el final de Slvame, previsto para el viernes... Increases were transient and did not appear to be an effective treatment for early-onset alcoholism studies have assessed ondansetron placebo... And initiate the vomiting reflex:408-13. doi: 10.1007/s00213-002-1002-9, Noronha A. Pharmacol Ther ) over 4 days for total! 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Same active ingredients ( e.g cisplatin do not affect the pharmacokinetics and pharmacodynamics of temazepam Torsade de Pointes have released... Patients treated with ondansetron, Cho YE, Song BJ, Noronha A. Pharmacol Ther these events were,! ( 5 % ) placebo in preventing postoperative nausea and vomiting associated with initial and repeat courses moderately! Effective than placebo in addition, postmarketing cases of Torsade de Pointes have reported. Not been studied only once before bedtime of renal impairment ( mild, moderate, severe! Was based on the pharmacokinetics of ondansetron has been shown to slow colonic transit in healthy subjects microemulsion! 1,320 cGy for oral administration of ondansetron had no effect on serotonin akbar M Cho!
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