I did not take a tablet of amlodipine besylate 10 mg also … read more. The recommended dose range for patients with coronary artery disease is 5 to10 mg once daily. Töflurnar takist með vatnsglasi. Similar results were obtained in patients receiving amlodipine besylate tablets and concomitant beta-blockers. Tell your doctor right away if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, fainting. Carcinogenesis, Mutagenesis, Impairment of Fertility, Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5 mg, 1.25 mg, or 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. General advice about amlodipine besylate tablets. For the mouse, the highest dose was, on a mg/m2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. It's also given to treat chest pain (angina) and other conditions . Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A4 inhibitors. In controlled clinical trials directly comparing NORVASC (N=1730 . 1 tablet indeholder 5 mg (delekærv) eller 10 mg amlodipin (som besilat).Â, Initialdosis nedsættes, og der optitreres langsomt.Â, Baggrund: Der er data for omkring 100 1. trimester-eksponerede uden tegn pÃ¥ overhyppighed af uønsket fosterpÃ¥virkning. Increased Angina or Myocardial Infarction. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. AMLODIPINE (am LOE di peen) is a calcium-channel blocker. Amlodipine is not bad for your heart, and even for folks with heart failure, amlodipine is a reasonable option to lower your blood pressure.. 2) Amlodipine isn't as good as newer blood pressure medications. Pfizer Safety. If myopathy or muscle weakness occur, simvastatin dose should be reduced to 20 mg daily or the patient should be switched to pravastatin, fluvastatin or rosuvastatin. Metabolic and Nutritional: hyperglycemia, thirst. Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy. Amlodipin/Valsartan Krka. The recommended dose for chronic stable or vasospastic angina is 5 to10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (respectively, 8 times2 and 23 times2 the maximum recommended human dose of 10 mg on a mg/m2 basis) during their respective periods of major organogenesis. âTake amlodipine once a day, with or without food.âIt may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating). Go to Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information. Normotensive subjects experienced no clinically significant change in blood pressures (+1/-2 mmHg). The sustained efficacy of amlodipine besylate tablets in angina patients has been demonstrated over long-term dosing. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Proprietary Name: AMLODIPINE BESYLATE Ved nyretransplanterede patienter er der observeret øget koncentration af ciclosporin ved samtidig behandling med amlodipin, og dosis af ciclosporin bør monitoreres. It should not be used to treat angina when it occurs. Properly discard this product when it is expired or no longer needed. Increases in symptom-limited exercise time averaged 12.8% (63 sec) for amlodipine besylate tablets 10 mg, and averaged 7.9% (38 sec) for amlodipine besylate tablets 5 mg. amlodipine besylate tablets 10 mg also increased time to 1 mm ST segment deviation in several studies and decreased angina attack rate. Store the liquid form of this medication in the refrigerator away from light. Call 800-438-1985 *. Adjust dosage according to each patientâs need. Consult your doctor for more details. Submit a medical question for Pfizer prescription products. Lifestyle changes that may help this medication work better include exercising, stopping smoking, reducing stress, and eating a low-cholesterol/low-fat diet. In clinical studies in which amlodipine besylate tablets were administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters was observed. Sometimes, doctors will prescribe a medicine for a condition that is not written in the patient information leaflets. Store at 68 to 77 degrees F. Protect from light and moisture. The dosage is based on your medical condition and response to treatment. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose3 of 10 mg/day on a mg/m2 basis). If you have high blood pressure, taking amlodipine helps prevent future heart disease, heart attacks and strokes.. Amlodipine is also used to prevent chest pain caused by heart disease .. The aim of the present study was to evaluate the efficacy and safety of S-amlodipine 2.5 and 5 mg/d in patients with hypertension who were treatment-naive or previously received antihypertensive monotherapy. 10 mg Tablets. Lot # MP4344. Patients may feel more tired and sleepy than usual. Adult: PO Per tab contains amlodipine 5 mg and losartan potassium 50 mg: The recommended initial dose is 1 tab/day; it may be increased up to 2 tab/day. Neonatal Dosage (3kg) The effectiveness of 5 to 10 mg/day of amlodipine besylate tablets in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine besylate tablets, 354 placebo) with chronic stable angina. 1 Name of Medicine. Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine. Co-administration of amlodipine with warfarin did not change the warfarin prothrombin response time. Biotilgængelighed 64-80 % pga. Discuss the risks and benefits with your doctor. Check the manufacturer's information or ask your pharmacist for specific directions. Amlodipine is a prescription medicine used primarily to treat high blood pressure in adults and kids at least 6 years old. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure. Talk to your pharmacist for more details. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina. Adverse events were similar to those seen in adults. Amlodipine belongs to a class of drugs known as calcium channel blockers.It works by relaxing blood vessels so blood can flow more easily.. Amlodipine is also used to prevent certain types of chest . Amlodipine besylate tablets have been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Because of the gradual onset of action, acute hypotension is unlikely. In vitro data indicate that amlodipine has no effect on the human plasma protein binding of digoxin, phenytoin, warfarin, and indomethacin. British National Formulary, 79th Edition (Mar 2020); British Medical Association and Royal Pharmaceutical Society of Great Britain, London. This is not a complete list of possible side effects. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. unpleasant breath odor. Most side effects are mild or moderate: âheadacheâswelling of your legs or anklesâtiredness, extreme sleepinessâstomach pain, nauseaâdizzinessâflushing (hot or warm feeling in your face)âarrhythmia (irregular heartbeat)âheart palpitations (very fast heartbeat). Its empirical formula is C20H25CIN2O5 ⢠C6H6O3S. Amlodipine besylate tablets, USP are indicated for the treatment of confirmed or suspected vasospastic angina. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.âare breast-feeding. Medical Valley Invest AB. In a long-term (follow-up at least 6 months, mean 13.8 months) placebo-controlled mortality/morbidity study of amlodipine besylate tablets 5-10 mg in 1153 patients with NYHA Classes III (n=931) or IV (n=222) heart failure on stable doses of diuretics, digoxin, and ACE inhibitors, amlodipine had no effect on the primary endpoint of the study which was the combined endpoint of all-cause mortality and cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure), or on NYHA classification, or symptoms of heart failure. Within the physiologic pH range, amlodipine is an ionized compound (pKa= 8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. 9AM-5PM ET Monday to Friday; excluding holidays. Do not use a household spoon because you may not get the correct dose. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Northwind Pharmaceuticals, LLC. Amlodipin Sandoz, Tablett 5 mg . Symptoms of overdose may include: fainting, severe dizziness. Antihypertensivum.Â, Tabletter. While amlodipine is calcium antagonist . You can ask your pharmacist or doctor for information about amlodipine besylate tablets, or you can visit Camber Pharmaceuticals website at www.camberpharma.com or call 1-866-495-8330. Amlodipine (Norvasc) is a calcium channel blocker drug prescribed for the treatment of high blood pressure and the treatment and prevention of chest pain caused by angina. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Death resulted from a mixed overdose of 140 mg and 10 mefenamic acid capsules in a 15 year old girl, and from a mixed overdose of amlodipine 70 mg and an unknown quantity of oxazepam in a 63 year old woman. If you notice other effects not listed above, contact your doctor or pharmacist. Who should not use amlodipine besylate tablets? Lotrel (amlodipine / benazepril) is typically taken at 2.5 mg to 10 mg of amlodipine and 10 mg to 40 mg of benazepril once daily. Call Us. Learn how to monitor your own blood pressure at home, and share the results with your doctor. Children—Use and dose must be determined by your doctor. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. However, the dose is usually not more than 10 mg per day. Interaktioner. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. Patients (76% males, 89% Caucasian, 93% enrolled at US sites, 89% with a history of angina, 52% without PCI, 4% with PCI and no stent, and 44% with a stent) were randomized to double-blind treatment with either amlodipine besylate tablets (5 to 10 mg once daily) or placebo in addition to standard care that included aspirin (89%), statins (83%), beta-blockers (74%), nitroglycerin (50%), anti-coagulants (40%), and diuretics (32%), but excluded other calcium channel blockers. Ekki er hægt að skipta 5 mg töflu í tvo jafna skammta. B. Amlodipine "Vitabalans" VitabalansAmlodipin, tabletter 5 mg, Genordn. It increases the myocardial oxygen delivery in patients with vasospastic angina. The usual dose of amlodipine is 5 milligrams once daily. risiko for bl.a. first pass-metabolisme i leveren. Losartan (sold under various brand names such as Losacar) can be started at 50 mg once daily and increased to 100mg once daily, if necessary. If that happens, call your doctor right away or go directly to a hospital emergency room. stigning i AUC for amlodipin. Fatigue is a common side effect of 10 mg amlodipine besylate 1. Carefully measure the dose using a special measuring device/spoon. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)]. If it is near the time of the next dose, skip the missed dose. Forsigtighed ved dosisøgning til ældre. 29300-0243-10: It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. A similar increase in AUC was observed in patients with moderate to severe heart failure. Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine. Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies. Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. Amlodipine besylate tablets may cause the following side effects. It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. Call your doctor for medical advice about side effects. If you have any questions about amlodipine besylate tablets, ask your doctor. Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. The benefit of such a long half-life is the ability to have once-daily dosing. Your doctor or pharmacist can give you a list of these ingredients. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A4 inducers. Mfg. Co-administration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine. It works . Use other medications (such as sublingual nitroglycerin) to relieve attacks of chest pain as directed by your doctor. Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. In hypertensive patients with normal renal function, therapeutic doses of amlodipine besylate tablets resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria. Datamængden tillader ikke at udelukke en øget risiko. This drug may make you dizzy. This relaxes your blood vessels, which can reduce the amount of work the heart has to do. Diltiazem hæmmer metabolismen af amlodipin sandsynligvis via CYP3A4, idet plasmakoncentrationen forhøjes med ca. Tell your doctor if you: âever had heart diseaseâever had liver problemsâare pregnant, or plan to become pregnant. Middel mod angina pectoris. Lowering blood pressure may lower your risk of a stroke or heart attack. Do not double the dose to catch up. Medical professionals, medical facility employees 855.571.2100. I hate this drug because of the urine.Hoping to get a different drug. General: allergic reaction, asthenia,1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Respiratory System: dyspnea, 1 epistaxis. Otherwise, call a poison control center right away. Sandoz AS. 50%, og virkningen af amlodipin øges. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Do not give amlodipine besylate tablets to other people, even if they have the same symptoms you have. The primary endpoint is summarized in Figure 1 below. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. High blood pressure comes from blood pushing too hard against your blood vessels. Therefore combined treatment with amlodipine and up to 40 mg simvastatin daily seems clinically justifiable if the patient does not report adverse events. McKesson Acceptable Dating: we will ship >= 90 days. Most adverse reactions reported during therapy with NORVASC were of mild or moderate severity. Your doctor will know if amlodipine besylate tablets are right for you. It is also used to prevent chest pain. The outcome of this study was largely derived from the prevention of hospitalizations for angina and the prevention of revascularization procedures (see Table 1). Amlodipine Besylate Tablets, USP, 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are supplied as white, round, flat-faced, beveled edged tablets, engraved with "10 mg" on one side and supplied as follows: NDC 43489-101-01 Bottle of 90. A very serious allergic reaction to this drug is rare. yellow eyes or skin. In humans, experience with intentional overdosage of amlodipine is limited. A case of accidental drug overdose has been documented in a 19 month old male who ingested amlodipine besilate 30 mg (about 2 mg/kg). Tablett 10 mg. Bild saknas. Patients may feel more tired and sleepy than usual. This is a summary of the public assessment report (PAR) for Amlodipin Medical Valley. The dose may be increased to 10 mg daily, if necessary. Both 5mg and 10mg strengths are available in pack sizes of 28 tablets. What should I avoid while taking amlodipine besylate tablets? A nurse is administering medications to four clients using an automated dispensing system. Adult: Initially, 5 mg once daily.Dosage is individualised and may be increased after at least 1-2 weeks. Samme effekt kan forventes med stærke inhibitorer af . Compared to nifedipine and other medications in the dihydropyridine class, amlodipine has the longest half-life at 30 to 50 hours. It works by relaxing blood vessels so blood can flow more easily. Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase, chest pain continues or worsens). After stabilization, by day 6, he was transferred for rehabilitation. flushing (warmth, redness, or tingly feeling). Amlodipine besylate tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, USP are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. Fatigue that becomes bothersome should be . Weber-Schoendorfer C, Hannemann D, Meister R et al. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. What is the dosage of Amlodipine and Losartan? It should not be used to treat attacks of chest pain when they occur. Amlodipine besylate tablets have been compared to placebo in four 8 to 12 week studies of patients with NYHA Class II/III heart failure, involving a total of 697 patients. Amlodipine belongs to a class of drugs known as calcium channel blockers. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Coughing going on 9 months, I have seen a pulmonary, ent, and a heart doctor. Identifikation. Mfg for: Camber Pharmaceuticals, Piscataway, NJ 08854 Lot#: Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256, Set id: fc7d39d7-e006-4ed6-a31c-827452603002. Should I avoid certain foods while taking Amlodipine BESYLATE? Report Adverse Event. For a complete list, ask your doctor or pharmacist. Amlodipine 10 mg are white, oval biconvex, smooth surface tablets embossed R on one side and 178 on the other side. The recommended adult starting dose is 5 mg taken once daily. The transfer medications comprised of 5 mg of amlodipine orally daily, 5 mg of enalapril orally daily, 40 mg of enoxaparin subcutaneous daily and 50,000 U of vitamin D2 (Ergocalciferol) orally every week. Total combined all-cause mortality and cardiac morbidity events were 222/571 (39%) for patients on amlodipine besylate tablets and 246/583 (42%) for patients on placebo; the cardiac morbid events represented about 25% of the endpoints in the study. Older adults may be more sensitive to the effects of this drug, especially dizziness. This product contains 2 medications: amlodipine and atorvastatin. It is slightly soluble in water and sparingly soluble in ethanol. Patients receiving 2.5 mg or 5 mg at the end of 8 weeks had significantly lower systolic blood pressure than those secondarily randomized to placebo. Lab and/or medical tests (such as blood pressure) should be done while you are taking this medication. Product Dating. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Amlodipine is used with or without other medications to treat high blood pressure. F: 66 10 days: 5 mg 1X D 1/14/2020 Email: 2 . This medicine is only available on prescription. Consult your pharmacist or local waste disposal company for more details. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. Amlodipin Sandoz, Tablett 10 mg . Store in a tight, light-resistant container. With amlodipine besylate tablets there were more reports of pulmonary edema. In Canada - Call your doctor for medical advice about side effects. The safety of calcium channel blockers during pregnancy: a prospective, multicenter, observational study. Urinary System: micturition frequency, micturition disorder, nocturia. Lotrel is a combination of amlodipine besylate and benazepril hydrochloride. eHealthMe is studying from 45,688 Amlodipine besylate users for its effectiveness, alternative drugs and more. mTOR-hæmmere som sirolimus og everolimus er CYP3A-substrater. Rifampicin (tuberkulosemiddel) og naturlægemidler, der indeholder perikon, kan ændre virkningen af Amlodipin "Medical Valley", og blodtrykket skal overvåges. Proprietary Name: AMLODIPINE BESYLATE 2019; , https://janusinfo.se/beslutsstod/janusmedfosterpaverkan.4.72866553160e98a7ddf1ce6.html (Lokaliseret 1. juli 2019), 4039. Do not store in the bathroom. Wait and take the next dose at your regular time.âOther medicines: You can use nitroglycerin and amlodipine besylate tablets together. 50%, og virkningen af amlodipin øges. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Check your blood pressure regularly while taking this medication. For combination therapy, treatment was started with 2.5 mg amlodipine and 10 mg lisinopril per day. Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Does Amlodipine BESYLATE interact with other drugs you are taking? Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. Amlodipine is available in the form of tablets, capsules, liquid solutions, or suspensions, and usually comes in strengths ranging from 2.5 mg to 10 mg. Amlodipine is commonly sold under brand names, including Norvasc (tablets & capsules) and Katerzia (liquid solution), and is also available as a generic medication. Adults—5 to 10 milligrams (mg) once a day. PLEASE SEE THE MANUFACTURER'S DATA AT THE FDA SITE REGARDING ALL ADVERSE REACTIONS: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7aaf923d-5b82-4a85-bb10-5850087da487. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Sleeping at least eight hours each night and taking a midday nap if possible may help users feel more awake and energized throughout the day. Samme effekt kan forventes med stærke inhibitorer af CYP3A4 (fx itraconazol, HIV-proteasehæmmere). amlodipine besylate: Norvasc Pharmacologic class: Calcium channel blocker Therapeutic class: Antihypertensive Pregnancy risk category C Action Inhibits influx of extracellular calcium ions, thereby decreasing myocardial contractility, relaxing coronary and vascular muscles, and decreasing peripheral resistance Availability Tablets: 2.5 mg, 5 . The most common side effects are headache and edema. Electrophysiologic Effects: Amlodipine besylate tablets do not change sinoatrial nodal function or atrioventricular conduction in intact animals or man. If massive overdose should occur, initiate active cardiac and respiratory monitoring. rash. Drug interactions, dosage, and pregnancy and breastfeeding safety information are provided. 7/31/2014 Amlodipine Recall, Class II. Alla godkända läkemedel får ett godkännandenummer, ett så kallat MT-nummer. 10 mg to placebo (N= 1250), discontinuation of amlodipine besylate tablets due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). Learn More. Amlodipine belongs to a group of medicines called calcium channel blockers. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure. It can be used by itself or with other medicines to treat these conditions. Dosing usually starts low, and can be increased depending on your response to the medication. Trots att det är samma läkemedel kan det i vissa fall förekomma skillnader mellan parallellimporterade och direktimporterade läkemedel, t ex avseende färgämnen eller texten på innerförpackningen. eHealthMe is studying from 45,688 Amlodipine besylate users for its effectiveness, alternative drugs and more.
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