Oral synthetic antiprotozoal agent for treatment of cryptosporidiosis or giardiasis caused by Cryptosporidium parvum or Giardia lamblia, respectively; is the first drug specifically approved for treating cryptosporidiosis; also effective in treating diarrhea due to other protozoa such as Giardia duodenalis, G. intestinalis and Entamoeba histolytica. 200 mg PO twice daily for 3 days as an alternative then chronic suppressive therapy. Diarrhea resolved after 1 week in 81% (38 of 47) of nitazoxanide-treated patients vs. 40% (17 of 42) of placebo group. No studies have been performed to determine if there are interactions with other drugs that exhibit high protein binding (e.g., hydantoins like phenytoin or fosphenytoin, the sulfonylureas, or salicylates). 1 to 3 years: 100 mg orally every 12 hours 4 to 11 years: 200 mg orally every 12 hours 12 years or older: 500 mg orally every 12 hours Duration of Therapy: 3 days Use: For the treatment of diarrhea due to G lamblia or C parvum. Duration. If it is close to the time for your next dose, skip the missed dose and go … Alinia:- Discard reconstituted product if not used within 7 days- Store at 77 degrees F; excursions permitted to 59-86 degrees F. Nitazoxanide is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any component of the formulation. Nitazoxanide, a thiazolide with activity against anaerobic bacteria, protozoa and viruses (van den Enden, 2009), also exhibits anthelminthic properties. constipation / Delayed / 0-1.0dysuria / Early / 0-1.0elevated hepatic enzymes / Delayed / 0-1.0anemia / Delayed / 0-1.0hypertension / Early / 0-1.0sinus tachycardia / Rapid / 0-1.0, abdominal pain / Early / 6.6-7.8diarrhea / Early / 2.1-4.2headache / Early / 1.1-3.1nausea / Early / 0-3.0vomiting / Early / 0-1.1anorexia / Delayed / 0-1.0dyspepsia / Early / 0-1.0appetite stimulation / Delayed / 0-1.0xerostomia / Early / 0-1.0flatulence / Early / 0-1.0insomnia / Early / 0-1.0hypoesthesia / Delayed / 0-1.0dizziness / Early / 0-1.0tremor / Early / 0-1.0drowsiness / Early / 0-1.0pelvic pain / Delayed / 0-1.0back pain / Delayed / 0-1.0infection / Delayed / 0-1.0influenza / Delayed / 0-1.0fever / Early / 0-1.0malaise / Early / 0-1.0asthenia / Delayed / 0-1.0amenorrhea / Delayed / 0-1.0urine discoloration / Early / 0-1.0pruritus / Rapid / 0-1.0diaphoresis / Early / 0-1.0rash / Early / 0-1.0otalgia / Early / 0-1.0iridal discoloration / Delayed / 0-1.0epistaxis / Delayed / 0-1.0pharyngitis / Delayed / 0-1.0rhinitis / Early / 0-1.0leukocytosis / Delayed / 0-1.0syncope / Early / 0-1.0myalgia / Early / 0-1.0muscle cramps / Delayed / 0-1.0gastroesophageal reflux / Delayed / Incidence not knownurticaria / Rapid / Incidence not known. 6 mg PO or IV q24h Pediatric dosing*: 0.15 mg/kg/dose IV q24h (max: 6 mg/dose) Duration: Maximum 10 days, or until discharge Shorter duration is reasonable to consider in patients who have improved rapidly or are experiencing adverse events from steroids. By rectum. Reconstitute ALINIA for Oral Suspension as follows: Keep container tightly closed, and shake the suspension well before each administration. 6 Aluminum Lake, and FD&C Blue No. Add approximately one-half of the 48 mL of water required for reconstitution and shake vigorously to suspend powder. No other clinical studies have been conducted to specifically exclude the possibility of interactions between nitazoxanide and other medicinal products which are not highly-protein bound. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. 1,000 mg/day PO per FDA-approved labeling; however, doses up to 2,000 mg/day PO have been used off-label. NOTE: A single tablet contains a greater amount of nitazoxanide than is recommended for children 11 years and younger, and therefore, nitazoxanide tablets should not be used in this age group. 5.6 Metabolism/Metabolites Rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide), followed by conjugation, primarily by glucuronidation to tizoxanide glucuronide. (200 mg nitazoxanide) taken orally every 12 hours with food. There is no information about the presence of nitazoxanide in human milk, the effects on the breast-fed infant, or the effects on milk production. 500 mg PO every 12 hours with food for 3 days. Oral- Cryptosporidiosis, Giardiasis- Adult: 500 mg every 12 hour for 3 days. Alinia Oral Pwd F/Recon: 5mL, 100mgAlinia Oral Tab: 500mg. It works by stopping the growth of certain protozoa that cause diarrhea. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Alinia Tablets are round, yellow, film-coated tablets debossed with Alinia on one side and 500 on the other side. Aspirin, ASA; Butalbital; Caffeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. 500 mg PO twice daily for 3 days. Nitazoxanide has not been studied in patients with hepatic impairment. Aspirin, ASA: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. 10 Aluminum Lake, FD&C Yellow No. Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for nitazoxanide and any potential adverse effects on the breast-fed infant from nitazoxanide or the mother's underlying condition. What is Nitazoxanide for: This medication is an antiprotozoal compound, effective in treating diarrhea caused by Cryptosporidium and Giardia. 500 mg PO every 12 hours with food for 3 days. Therefore, nitazoxanide should be administered with caution to patients with biliary tract disease, hepatic disease, renal disease, renal failure, renal impairment, or combined renal and hepatic disease. Usual Pediatric Dose for Giardiasis. 100 mg PO twice daily for 3 days. What is the dosage used for nitazoxanide? Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: ALINIA tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group. In acute studies in rodents and dogs, the oral LD50 was higher than 10,000 mg/kg, single oral doses of up to 4000mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. Agents for Amoebiasis and Other Protozoal Diseases. Take a missed dose as soon as you think about it. Nitazoxanide and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of sporozoites and oocysts of Cryptosporidium parvum and the trophozoites of Giardia lamblia. Nitazoxanide has been experimentally administered to Giardia-infected dogs previously at an oral dose of 25 mg/kg twice a day, with no efficacy, as 37.5 to 50% of dogs that completed the experimental protocol, remained positive for Giardia . The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins (> 99%). Therefore, caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. syrup, FD&C Red #40 and natural strawberry flavoring. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. US-based MDs, DOs, NPs and PAs in full-time patient practice can register for free on PDR.net. Reduce dosage by 50% if CrCl is 10-30 mL/min and by 75% if CrCl is . Adults and teenagers—Dose is based on body weight and must be determined by your doctor. Sulfonylureas: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 100 mg PO twice daily as an alternative then chronic suppressive therapy. Before using Nizonide Syrup, inform your doctor about your current list of medications, over the counter products (e.g. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. Effects of Missed Dosage of Nitazoxanide Take the missed dose as soon as noticed and if it is the time for next dose then skip the missed dose. 5 mL of ALINIA for Oral suspension. Aminosalicylate sodium, Aminosalicylic acid: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Data sources include IBM Watson Micromedex (updated 1 Apr 2021), Cerner Multum™ (updated 5 Apr 2021), ASHP (updated 6 Apr 2021) and others. Nitazoxanide. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. The manufacturer has reported that nitazoxanide does not affect the pharmacokinetics or anticoagulant effects of warfarin in healthy volunteers. Clinical studies of nitazoxanide did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger patients; however, elderly patients have a greater frequency of decreased hepatic, renal, or cardiac function. 1 to 3 years: 200 mg/day PO. Nitazoxanide has not been studied in patients with renal impairment. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. The objective of the study was to determine if metabolites other than T are present in the plasma and excreted after single dose oral administration of radiocarbon-labelled N in healthy subjects. 500 mg PO twice daily for 3 days an alternative then chronic suppressive therapy. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. It is approved for treatment of infectious diarrhea caused by Cryptosporidium parvum and Giardia lamblia in patients 1 year of age and older. Immunocompetent Persons 3; Adult dosage: 500 mg BID x 3 days: Pediatric dosage: 1-3 years: 100 mg BID x 3 days: 4-11 years: 200 mg BID x 3 days Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label. Nitazoxanide is 2-acetyloxy-N (5-nitro-2-thiazoly) benzamide. Send the page "" Pregnancy: No data with pregnant women to inform of drug-associated risk; No teratogenicity or fetotoxicity observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at maximum recommended human dose of 500 mg twice daily based on body surface area (BSA) Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Shake the oral suspension (liquid) well just before you measure a dose. Use with caution in patients with history of penicillin allergy. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Nitazoxanide has also exhibited activity against other protozoa such as Giardia duodenalis, G. intestinalis and Entamoeba histolytica. Children—Dose is based on body weight and must be determined by your doctor. Salsalate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Aspirin, ASA; Pravastatin: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. The parent drug nitazoxanide is not detected in plasma. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Izato Syrup OVERDOSE: IZATO Syrup Information on nitazoxanide overdosage is not available. is a product of Square Pharmaceuticals Ltd. Its generic name is Nitazoxanide. The current study aims to identify a nitazoxanide dose and schedule that will achieve plasma and lung trough concentrations above the minimum effective concentration reported for … Therefore, caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Aspirin, ASA; Carisoprodol; Codeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. © document.write(new Date().getFullYear()) PDR, LLC. Nitazoxanide is currently available in two oral dosage forms: a tablet (500 mg) and an oral suspension (100 mg per 5 ml when reconstituted). Nitazoxanide also has some antiviral activity; it is being studied for rotavirus infection and chronic hepatitis B and C infections.Resistance mechanisms to nitazoxanide by Cryptosporidium parvum, Giardia lamblia or other protozoa have not been examined. Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. doxycycline, metronidazole, Flagyl, albendazole, chloroquine, Vibramycin, tinidazole, mebendazole, nitazoxanide, praziquantel. The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins (> 99%). ).Some health conditions may make you more susceptible to the side-effects of the drug. Animal reproductive studies performed in rats and rabbits at doses up to 2 and 30 times the recommended daily human dose demonstrated no evidence of teratogenicity or fetotoxicity due to nitazoxanide. Discard any unused portion after 7 days. It can also be used in the treatment of Chronic hepatitis B, Chronic hepatitis C. Medically reviewed by Drugs.com. What do I do if I miss a dose? It works by stopping the growth of certain protozoa that cause diarrhea. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. 125 mg 3 times a day for 3 days, then 125 mg twice daily, for usual total treatment duration of 7 days. PDR.net is to be used only as a reference aid. Add remainder of water and again shake vigorously. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. The pharmacokinetic parameters of nitazoxanide listed are from studies performed in the pediatric population from 12 months to 11 years of age. Nitazoxanide oral suspension should be used in children 11 years and younger. Shake well prior to each administration.Measure dosage with calibrated spoon, cup, or oral syringe.Diabetic patients and caregivers should be aware that the oral suspension contains 1.48 g of sucrose per 5 ml. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded. There are no data with nitazoxanide in human pregnancy to inform a drug-associated risk. Results. In HIV-infected patients, clinical practice guidlines suggest that a regimen of 100 mg PO twice daily for up to 14 days in combination with optimized antiretroviral therapy and symptomatic treatment may be useful. 500 mg PO every 12 hours with food for 3 days. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Give with food. For Adult. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. Pregnancy: Teratogenic Effects Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Choline Salicylate; Magnesium Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. 500 mg PO twice daily for 10 days as an alternative for the treatment of the primary episode of C. difficile infection. Dosage. 600mg of nitazoxanide and 109.1h (95% CI Ethical 96.1—129.5; p=0.521) for subjects who received 300 mg of nitazoxanide, compared with 116.7h (95% CI 108.1—122.1) for subjects who received placebo. The researchers say, “It was possible to achieve plasma and lung tizoxanide concentrations, using proven safe doses of nitazoxanide, that exceed the … STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. No studies have been performed to determine if administration of the drug in the fasted state affects the pharmacokinetics of tizoxanide and tizoxanide glucuronide compared to administration with food. 10 mL of ALINIA for Oral Suspension. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. How does Nitazoxanide work: Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. No significant adverse reactions were reported. Magnesium Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. 500 mg PO every 12 hours with food for 3 days. Patients with diabetes mellitus or caregivers of these patients should be aware that the nitazoxanide oral suspension contains 1.48 g of sucrose per 5 ml. Last updated on Nov 4, 2020. The molecular formula is C12HgN3O5S and the molecular weight is 307.3. *Pediatric dosing is based on Add to Cart. ), allergies, pre-existing diseases, and current health conditions (e.g. In HIV-infected patients, clinical practice guidelines suggest that a regimen of 500 mg PO twice daily for up to 14 days in combination with optimized antiretroviral therapy and symptomatic treatment may be useful. No significant adverse reactions were reported. Nitazoxanide is an antiprotozoal agent or anti-parasitic agent which inhibits the multiplication of certain protozoa that cause diarrhea. Phenytoin: (Moderate) No interactions with other drugs have been reported by patients using nitazoxanide. The parent nitazoxanide is not detected in plasma. Safety and efficacy have not been established. Each tablet contains 500 mg of nitazoxanide. Nitazoxanide (Alinia) has comparable efficacy to metronidazole and is available in suspension for children as young as 1 year of age (100 mg twice a day for 3 days for younger than 4 years, 200 mg twice a day for 3 days for ages 4 to 11 years, 500 mg twice a day for adults). Objectives: Nitazoxanide (N), a new broad-spectrum parasiticidal agent, is rapidly deacetylated to tizoxanide (T). The median duration of therapy in the RECOVERY trial was 6 days. Antimicrobials are known to suppress H. pylori; thus, ingestion of these agents within 4 weeks of performing diagnostic tests for H. pylori may lead to false negative results. Because nitazoxanide may cause dizziness, patients should be advised to use caution if driving or operating machinery or performing other potentially hazardous tasks until the effects of the drug are known. Izato nitazoxanide Oral Uses Side effects dose In Pashto || Izato syrup Used for diarrhea. Follow your doctor's dosing instructions very carefully. NIZONIDE 30ML SYP. In HIV-infected patients, clinical practice guidelines suggest that a regimen of 500 to 1,000 mg PO twice daily for 14 days in combination with optimized antiretroviral therapy and symptomatic treatment may be useful. (14) Dosage: Adult: 500 mg PO bid for 3 d (14) Child: <1 yr: not documented 1-4 years: 100 mg (5 mL) per oral every 12 hrs for 3 days with food A randomised placebo-controlled trial in Peru administering nitazoxanide (500 mg (adults) and 100–200 mg (children) twice a day for 7 days) to Fasciola hepatica -infected patients reported cure rates of 60% in adults and 40% in children ( Favennec et al., 2003 ). Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Aspirin, ASA; Carisoprodol: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. After reconstitution, the oral suspension contains nitazoxanide 100 mg/5 ml.Storage: Store reconstituted suspension at controlled room temperature. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. 10 mL/min (high dosages may cause CNS toxicity) Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy. Considering that 50 mg/kg/day was not effective against giardiasis in dogs, a dose of 75 mg/kg was selected, hoping to achieve a greater efficacy. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Tap bottle until all powder flows freely. Select one or more newsletters to continue. In clinical trials in pediatric patients (n = 163), treatment with nitazoxanide significantly reduced time to resolution of symptoms/diarrhea and duration of hospitalization compared with control treatments. Protozoa are suspected as the cause when diarrhea lasts more than 7 days. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Uses. Aspirin, ASA; Omeprazole: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. The exact mechanism of action of nitazoxanide is unknown. In clinical trials in pediatric patients (n = 163), treatment with nitazoxanide significantly reduced time to resolution of symptoms/diarrhea and duration of hospitalization compared with control treatments. 1,000 mg PO twice daily as alternative therapy; however, effects may be minimal for patients with a low CD4 count. Nitazoxanide has not been studied in patients with compromised renal or hepatic function. Generic name: NITAZOXANIDE 500mgDosage form: tablet; powder, for oral suspension. Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. Studies of Giardia lamblia have shown that the PFOR enzyme from this organism directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The intervention group received syrup nitazoxanide twice daily (100 mg in 12-47 months, 200 mg in ≥4 yr) for 3 days along with standard treatment of diarrhea. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. 3 Days. Salicylates: (Moderate) The active metabolite of nitazoxanide, tizoxanide, is highly bound to plasma proteins. We do not record any personal information entered above. vitamins, herbal supplements, etc. CLINICAL PHARMACOLOGY Absorption: Following oral administration of Alinia Tablets or Oral Suspension, maximum plasma concentrations of the active metabolites tizoxanide and tizoxanide glucuronide are observed within 1-4 hours. For Child 1–4 years. Caution should be exercised when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices because competition for binding sites may occur. Keep taking nitazoxanide suspension as you have been told by your doctor or other health care provider, even if you feel well. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Maximum plasma concentrations (Cmax) of tizoxanide and tizoxanide glucuronide occur within 1—4 hours (Tmax). You should confirm the information on the PDR.net site through independent sources and seek other professional guidance in all treatment and diagnosis decisions. Guidelines recommend this quadruple therapy as a first-line treatment option. Fosphenytoin: (Moderate) No interactions with other drugs have been reported by patients using nitazoxanide.
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