If Mefenamic Acid is used in patients with severe heart failure, monitor patients for signs of worsening heart failure. The activity of these metabolites has not been studied. Use of NSAIDs, including Mefenamic Acid, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin in mediated follicular rupture required for ovulation. Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID). Avoid use of NSAIDs, including Mefenamic Acid, in pregnantwomen starting at 30 weeks of gestation (third trimester) (see PRECAUTIONS; Pregnancy). For the relief of acute pain in adults and adolescents ≥14 years of age, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours as needed, usually not to exceed one week. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. For non-prescription products, read the label or package ingredients carefully. Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS; Cardiovascular Thrombotic Events ). Many times mefenamic acid … Descriptions Mefenamic acid is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain. Concomitant use of Mefenamic Acid and pemetrexed may increase the risk of pemetrexed­associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). It is used to reduce swelling and to treat pain. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Renal Impairment: Mefenamic Acid pharmacokinetics have not been investigated in subjects with renal insufficiency. It can help to relieve: symptoms of inflammation, such as redness and swelling pain and discomfort caused by arthritis, muscular or rheumatic disorders headache or toothache There are no adequate and well-controlled studies of Mefenamic Acid in pregnant women. Following multiple doses, plasma levels are proportional to dose with no evidence of drug accumulation. Similarly, a peak plasma level of 8 mcg/mL was observed at 6 to 8 hours for the carboxy metabolite and its glucuronide. The metabolites may undergo glucuronidation and Mefenamic Acid is also glucuronidated directly. For more information, call 1-855-839-8195. Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Avoid use of NSAIDs, including Mefenamic Acid, in pregnant women starting at 30 weeks of gestation (third trimester) (see WARNINGS; Premature Closure of Fetal Ductus Arterious). For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs. Editor. NSAIDs, including Mefenamic Acid, may increase the risk of bleeding events. Mefenamic acid is also used to treat menstrual pain. For the treatment of primary dysmenorrhea, the recommended dose is 500 mg as an initial dose followed by 250 mg every 6 hours, given orally, starting with the onset of bleeding and associated symptoms. The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. Other adverse reactions, which occur rarely are: Body as a whole - anaphylactoid reactions, appetite changes, death, Cardiovascular system - arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive system - eructation, liver failure, pancreatitis, Hemic and lymphatic system - agranulocytosis, hemolytic anemia, aplastic anemia, lymph­ adenopathy, pancytopenia, Metabolic and nutritional - hyperglycemia, Nervous system - convulsions, coma, hallucinations, meningitis, Respiratory - respiratory depression, pneumonia, Skin and appendages - angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens - Johnson syndrome, urticaria, Special senses - conjunctivitis, hearing impairment. Mefenamic Acid concentrations reached during therapy have produced in vivo effects. Available for Android and iOS devices. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. MICRO LABS LIMITED, aspirin, acetaminophen, tramadol, ibuprofen, Tylenol, naproxen, diclofenac, oxycodone, celecoxib, Celebrex. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. NSAIDs and some other medicines can interact with each other and cause serious side effects. What are the possible side effects of NSAIDs? Mefenamic acid is in a class of medications called NSAIDs. It is also used to treat painful menstrual periods. stomach pain, indigestion, nausea, vomiting; This is not a complete list of side effects and others may occur. Consider withdrawal of NSAIDs, including Mefenamic Acid, in women who have difficulties conceiving or who are undergoing investigation of infertility. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. This product is intended for children but may be given to adults. Mefenamic Acid may cause prematureclosure of the ductus arteriosus. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In a multiple dose trial of normal adult subjects (n= 6) receiving 1-gram doses of Mefenamic Acid four times daily, steady-state concentrations of 20 mcg/mL were reached on the second day of administration, consistent with the short half-life. In another study, dietary administration of Mefenamic Acid at a dose of 155 mg/kg (equivalent to the MRHD of 1500 mg/day on a mg/m 2 basis) to females 15 days prior to mating through to weaning resulted in smaller average litter sizes and higher incidence of perinatal death. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see, ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers, To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or. Mefenamic Acid cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Because cross-reactivity between aspirin and other NSAIDs has been reported in suchaspirin-sensitivepatients,mefenamicacid is contraindicated in patients with thisform of aspirin sensitivity (see CONTRAINDICATIONS). Mefenamic acid is not approved for use by anyone younger than 14 years old. Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See CLINICALPHARMACOLOGY, ADVERSEREACTIONS). Mefenamic Acid concentrations reached during therapy have produced in vivo effects. The bioavailability of the capsule relative to an IV dose or an oral solution has not been studied. Ask a doctor or pharmacist before using any cold, allergy, or pain medication. During concomitant use of Mefenamic Acid and lithium, monitor patients for signs of lithium toxicity. Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile checked periodically (see WARNINGS; Gastrointestinal Bleeding, Ulceration and Perforation, and Hepatotoxicity ). Although not all of these side effects may occur, if they do occur they may need medical attention. PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY Medically reviewed by Drugs.com on Aug 31, 2020. Because Mefenamic Acid is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. A peak plasma level approximating 20 mcg/mL was observed at 3 hours for the hydroxy metabolite and its glucuronide (n= 6) after a single 1-gram dose. These conditions can occur without warning while you are using mefenamic acid, especially in older adults. Inform patients that the concomitant use of Mefenamic Acid with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased riskofgastrointestinaltoxicity,and little or no increase in efficacy (see WARNINGS; Gastrointestinal Bleeding, Ulceration and Perforation, PRECAUTIONS; Drug Interactions).Alertpatients that NSAIDsmay be present in “over the counter” medications for treatment of colds, fever, or insomnia. Do not take extra medicine to make up the missed dose. It was discovered and brought to market by Parke-Davis in the … Mefenamic acid concentrations reached during therapy have produced in vivo effects. 30 Capsules This solu- tion is stable for up to 7 days. Select one or more newsletters to continue. See Table 2 for clinically significant drug interactions with Mefenamic Acid. NSAIDs, including Mefenamic Acid, can lead to new onset of hypertension or worsening of pre­ existing hypertension, either of which may contribute to the increased incidence of CV events. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Pharmacokinetic Parameter Estimates for Mefenamic Acid. Mefenamic acid inhibits the activity of the enzymes cyclo-oxygenase I and II, resulting in a decreased formation of precursors of prostaglandins … Seek emergency help if anaphylactic reaction occurs. Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including Mefenamic Acid may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. The concomitant use of Mefenamic Acid with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat. In controlled, double-blind, clinical trials, Mefenamic Acid was evaluated for the treatment of primary spasmodic dysmenorrhea. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. Because of the potential for serious adverse reactions in nursing infants from Mefenamic Acid, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. Patients received either Mefenamic Acid, 500 mg (2 capsules) as an initial dose of 250 mg every 6 hours, or placebo at onset of bleeding or of pain, whichever began first. Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDS), Mefenamic Acid (mef-e-NAM-ik AS-id) Capsules, USP 250 mg. What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? Instruct patients to seek immediate emergency help if these occur (see CONTRAINDICATIONS, WARNINGS; Anaphylactic Reactions). If you take mefenamic acid on a regular basis, take a missed dose as soon as you think about it. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. If you would like more information about NSAIDs, talk with your healthcare provider. Pregnant rabbits given 50 mg/kg of Mefenamic Acid (0.6-times the MRHD on a mg/m 2 basis) from GD 6 to GD 18 did not result in any clear treatment-related adverse developmental effects. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. If the pain of your sty is too disturbing that it keeps you from doing your normal daily activities, you can ask your eye doctor to prescribe a medication to relieve the pain. Last updated on Jan 1, 2020. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. A false-positive reaction for urinary bile, using the diazo tablet test, may result after Mefenamic Acid administration. Studies to evaluate the mutagenic potential of Mefenamic Acid have not been completed. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Mefenamic Acid Capsules, USP A subpopulation of patients withasthmamay have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Concomitant use of Mefenamic Acid and cyclosporine may increase cyclosporine’s nephrotoxicity. Its name derives from its systematic name, dimethylphenylaminobenzoic acid. are pregnant or plan to become pregnant. This medicine may be used to treat osteoarthritis and rheumatoid arthritis. Each capsule also contains lactose monohydrate. Aspirin can cause bleeding in the brain, stomach, and intestines. Mefenamic Acid is a potent inhibitor of prostaglandin synthesis in vitro. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding, past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs, taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”, at the lowest dose possible for your treatment. The concomitant use of Mefenamic Acid with other NSAIDs or salicylates is not recommended. Safety and effectiveness in pediatric patients below the age of 14 have not been established. However, incidences of resorption were greater in treated compared to control animals. Mefenamic acid belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Check with your doctor immediately if any of the following side effects occur while taking mefenamic acid: More common. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( seeWARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Mefenamic acid is a member of the anthranilic acid derivatives class of nonsteroidal anti-inflammatory drugs, and is used to treat mild to moderate pain. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. The apparent volume of distribution (Vzss/F) estimated following a 500-mg oral dose of Mefenamic Acid was 1.06 L/kg. Mefenamicacid is contraindicated in the following patients: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Pregnant rats administered 249 mg/kg of Mefenamic Acid (1.6-times the MRHD of 1500 mg/day on a mg/m 2 basis) from GD 6 to GD 15 did not result in any clear adverse developmental effects. Mefenamic acid and its metabolites were measured using an old, insensitive assay method. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Half-lives of metabolites I and II have not been precisely reported, but appear to be longer than the parent compound. Call your doctor for medical advice about side effects. In animal reproduction studies in rats and rabbits when dosed throughout gestation, there were no evidence of developmental effects at a dose of Mefenamic Acid 1.6-times and 0.6-times the maximum recommended human dose (MRHD), respectively. As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Concomitant use of Mefenamic Acid with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy. Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). Avoid drinking alcohol. severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Keep the bottle tightly closed when not in use. Avoid the use of Mefenamic Acid in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Avoid the use of Mefenamic Acid in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. General information about the safe and effective use of NSAIDs. Mefenamic Acid is contraindicated in patients with previous seriousskinreactionstoNSAIDs (see CONTRAINDICATIONS). Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (, In the setting of coronary artery bypass graft (CABG) surgery (see. Mefenamic acid is a member of the anthranilic acid derivatives (or fenamate) class of nonsteroidal anti-inflammatory drugs (NSAIDs), and is used to treat mild to moderate pain. In a single dose study (n= 6), ingestion of an antacid containing 1.7-gram of magnesium hydroxide with 500-mg of Mefenamic Acid increased the C. Concomitant use of Mefenamic Acid and antacids is not generally recommended because of possible increased adverse events. A quantity of the mixed contents of 20 mefenamic acid capsules containing 0.5 g of the substance, or a quantity of the powdered tablets (after weighing and powdering of 20 mefenamic acid tablets) containing 0.5 g of the substance, is dissolved in 100 mL of warm absolute ethanol previously neutralized to the phenol red endpoint. Do not take NSAIDs: Before taking NSAIDs, tell our healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). Advise patients to stop Mefenamic Acid immediately if they develop any type of rash and contact their healthcare provider as soon as possible (see WARNINGS; Serious Skin Reactions). Do not start taking any new medicine without talking to your healthcare provider first. Participants receiving mefenamic acid experienced a marked decrease in bleeding during the 3 months of intervention, an initial sharp decrease being followed by a further lesser decrease (p 0.05 within group). NSAIDs, including Mefenamic Acid, can cause serious skin adverse reactions such as exfoliative dermatitis,Stevens-JohnsonSyndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Inform patients about the signs and symptoms of serious skin reactions and to discontinue the useofMefenamic Acid at the first appearance of skin rash or any other sign of hypersensitivity. Not all possible interactions are listed in this medication guide. Copyright 1996-2021 Cerner Multum, Inc. Bloody urine; bloody, black, or tarry stools Side Effects. Detailed Mefenamic Acid dosage information for adults and children. Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. View. During concomitant use of Mefenamic Acid and cyclosporine, monitor patients for signs of worsening renal function. See Table 2 for clinically significant drug interactions of NSAIDs with aspirin ( see PRECAUTIONS;Drug Interactions) . This list is not complete. Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). NDC 42571-258-30 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS, anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. Stop using mefenamic acid and call your doctor at once if you have: the first sign of any skin rash, no matter how mild; shortness of breath (even with mild exertion); signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or. Follow all directions on your prescription label. If Mefenamic Acid is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Mefenamic acid works by blocking the effect of natural chemicals called cyclo-oxygenase (COX) enzymes. Carefully consider the potential benefits and risks of Mefenamic Acid and other treatment options before deciding to use Mefenamic Acid. These events can occur at any time during use and withoutwarning symptoms. Mefenamic acid is used for the short-term treatment of mild to moderate pain from various conditions. These are not all of the possible side effects of NSAIDs. Mefenamic Acid and anticoagulants such as warfarin have a synergistic effect on bleeding. This drug is known to besubstantially excreted by the kidney, and the riskof toxic reactions to this drug may be greater in patients with impaired renal function. Along with its needed effects, mefenamic acid may cause some unwanted effects. Talk to your healthcare provider before using over-the-counter NSAID for more than 10 days. If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue Mefenamic Acid until a serious GI adverse event is ruled out. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Change Date. … Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath. After three menstrual cycles, patients were crossed over to the alternate treatment for an additional three cycles. Physicians and patients should remain alert for the development of such events throughout the entire treatment course, even in the absence of previous CV symptoms. During concomitant use of Mefenamic Acid and digoxin, monitor serum digoxin levels. Mefenamic Acid should not be administered to patients with pre-existing renal disease or in patients with significantly impaired renal function ( see WARNINGS; Renal Toxicity and Hyperkalemia) . This medicine is available only with your doctor's prescription. It works by stopping the body's production of a substance that causes pain, fever, and inflammation. Informpatientsnot to use low-dose aspirin concomitantly with Mefenamic Acid until they talk to their healthcare provider (see PRECAUTIONS; Drug Interactions). Anemia has occurred in NSAID-treated patients. These enzymes help to make other chemicals in the body, called prostaglandins. Read all patient information, medication guides, and instruction sheets provided to you. For more information, ask your healthcare provider or pharmacist about NSAIDs. Manage patients with symptomatic and supportive care following an NSAID overdosage. Version: 9.01. aspirin, acetaminophen, tramadol, ibuprofen, Tylenol, naproxen, diclofenac, oxycodone, celecoxib, Celebrex. ), discontinue Mefenamic Acid immediately, and perform a clinical evaluation of the patient. Rx Only It may harm them. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Use the lowest dose that is effective in treating your condition. Clinicalstudies of Mefenamic Acid did notinclude sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Mefenamic Acid should not be administered to patients with pre-existing renal disease or in patients with significantly impaired renal function ( seeWARNINGS; Renal Toxicity and Hyperkalemia). During concomitant use of Mefenamic Acid and methotrexate, monitor patients for methotrexate toxicity. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). 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Dosage adjustments in patients with a reversible delay in ovulation and heat relationship of unbound fraction to concentration..., dosage adjustments in patients with a reversible delay in ovulation and not! That accompanies each prescription dispensed pharmacist about NSAIDs pain in animal models as a NSAID or! ( me fe NAM ik as id ) is a nonsteroidal anti-inflammatory drug ( NSAID ) are contraindicated in with. Patients, as well as those with active GI bleeding, including epigastric pain dyspepsia! Propylene glycol & shellac procedures, such as acetaminophen, tramadol, ibuprofen, Tylenol,,.
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