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Regardless of Investigator Assessment of Causality*. Read reviews from GoodRx users who have taken Januvia and find the latest news on the drug. Five placebo-controlled add-on combination therapy studies were also conducted: one with metformin; one with pioglitazone; one with metformin and rosiglitazone; one with glimepiride (with or without metformin); and one with insulin (with or without metformin). See additional information. These side effects may go away during treatment as your body adjusts to the medicine. Receiving Combination Therapy (and Greater than in Patients Receiving Metformin alone, Sitagliptin Although not all of these side effects may occur, if they do occur they may need medical attention. O 0. Diabetes Treatment: Medication, Diet, and Insulin, Tips for Managing Type 1 and 2 Diabetes at Home, Combination with Metformin + Rosiglitazone (18 weeks), JANUVIA 100 mg + Metformin + Rosiglitazone, Combination with Glimepiride (+/-Metformin) (24 weeks), JANUVIA 100 mg + Glimepiride (+/-Metformin). Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma C max on average by 18 %. It’s used with diet and exercise to treat type 2 diabetes. Headache and other aches or pains: Drink plenty of water and ask your pharmacist to recommend a suitable painkiller. a common cold ; If experienced, these tend to have a Less Severe expression i . In a 12-week study of 91 patients with chronic renal insufficiency, 37 patients with moderate renal insufficiency were randomized to JANUVIA 50 mg daily, while 14 patients with the same magnitude of renal impairment were randomized to placebo. Side Effects What are the side effects of Janumet (Metformin And Sitagliptin)?. Pregnancy. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin/metformin may have other side effects, including: as Add-On Therapy to Glimepiride (with or without Metformin) or Insulin (with or without Metformin), The most common side-effects are feeling sick (nausea), headache, and nose or … Effect of Exenatide, Sitagliptin, or Glimepiride on b-Cell Secretory Capacity in Early Type 2 Diabetes DOI: 10.2337/dc14-0398 OBJECTIVE AgentsthataugmentGLP-1effectsenhanceglucose-dependentb-cellinsulinpro- Sitagliptin side effects Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling). Other important side effects of sitagliptin include: abdominal pain, nausea and; diarrhea. In the United Kingdom it is listed as less preferred than metformin or a sulfonylurea. INFREQUENT side effects If experienced, these tend to have a Severe expression i . It may also cause side effects because of the metformin. STEGLUJAN may cause serious side effects, including: See “What is the most important information I should know about STEGLUJAN?” ketoacidosis (increased ketones in your blood or urine). Learn about Januvia (sitagliptin), potential side effects, proper use and dosing, and popular alternatives. Last updated on May 30, 2020. We comply with the HONcode standard for trustworthy health information -. Breast feeding. Serious side effects may include angioedema, low blood sugar, kidney problems, pan Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Sitagliptin can cause several side effects and the severity differs from person to person. Before using Sitagliptin, inform your doctor about your current list of medications, over the counter products (e.g. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Januvia may interact with digoxin, probenecid, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), or beta-blockers. Januvia(Sitagliptin Phosphate) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. [Ref], Postmarketing reports: Worsening renal function[Ref], Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Side-effects, further information. As add-on to insulin studies, hypoglycemia was commonly reported. [See WARNINGS AND PRECAUTIONS]. The adverse reactions, excluding hypoglycemia, reported regardless of investigator assessment of causality in ≥5% of patients treated with JANUVIA 100 mg daily and more commonly than in patients treated with placebo, are shown in Table 1 for the clinical trials of at least 18 weeks duration. This medicine does not usually make you put on weight. In the study of JANUVIA as add-on combination therapy with metformin and rosiglitazone (Table 1), through Week 54 the adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo were: upper respiratory tract infection (JANUVIA, 15.5%; placebo, 6.2%), nasopharyngitis (11.0%, 9.3%), peripheral edema (8.3%, 5.2%), and headache (5.5%, 4.1%). Stop taking sitagliptin and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, with or without vomiting. Dosage. In the 24-week, placebo-controlled factorial study of initial therapy with JANUVIA in combination with metformin, the incidence of hypoglycemia was 0.6% in patients given placebo, 0.6% in patients given JANUVIA alone, 0.8% in patients given metformin alone, and 1.6% in patients given JANUVIA in combination with metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The recommended dose of Januvia is 100 mg once daily. In an additional, 24-week, placebo-controlled factorial study of initial therapy with sitagliptin in combination with metformin, the adverse reactions reported (regardless of investigator assessment of causality) in ≥5% of patients are shown in Table 2. Serious side effects can happen in people who take ONGLYZA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. The recommended dose of sitagliptin is 100 mg once daily.. Precautions. Before taking ONGLYZA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels. Consult your doctor before breastfeeding. A small increase in white blood cell count (WBC) was observed due to an increase in neutrophils. Manufacturer advises reduce dose to 50 mg once daily if eGFR 30–45 mL/minute/1.73 m 2. In conclusion, for obese/overweight patients, sitagliptin might exert a less potent effect regarding HbA 1C, FPG, PPG, and weight reduction than GLP-1 receptor agonists; however, there was no difference in hypoglycemic risk. Type 2 Diabetes: Signs, Symptoms, Treatments. Drug class: dipeptidyl peptidase 4 inhibitors, Blistering, peeling, loosening of the skin, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, pains in the stomach, side, or abdomen, possibly radiating to the back, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips. Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome [see WARNINGS AND PRECAUTIONS]; hepatic enzyme elevations; acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis [see INDICATIONS; WARNINGS AND PRECAUTIONS]; worsening renal function, including acute renal failure (sometimes requiring dialysis) [see WARNINGS AND PRECAUTIONS]; severe and disabling arthralgia [see WARNINGS AND PRECAUTIONS]; bullous pemphigoid [see WARNINGS AND PRECAUTIONS]; constipation; vomiting; headache; myalgia; pain in extremity; back pain; pruritus; mouth ulceration; stomatitis; rhabdomyolysis. Avoid—present in milk in animal studies. No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed in patients treated with JANUVIA. iam a doctor and i have dignosed sudden dibaties.i want ask about sitagliptin is a short acting or lond acting drug. Januvia (sitagliptin)." Merck got these two drugs approved by the U.S. Food and Drug Administration (FDA) in 2006 and 2007 and since then has made a huge amount of money. Januvia (sitagliptin), a DPP-4 inhibitor, is a diabetes medication used in combination with exercise and diet to improve blood glucose levels in individuals with type 2 diabetes. pregnancy, upcoming surgery, etc. The most common side effects of ertugliflozin include genital yeast infections and changes in urination. Dose adjustments . Pregnancy. Common side effects of Janumet include stomach upset, nausea, vomiting, constipation, diarrhea, headache, weakness, back pain, joint or muscle pain, metallic taste, vitamin B12 deficiency, and cold symptoms. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. When JANUVIA was coadministered with a sulfonylurea or with insulin, the percentage of patients with at least one adverse reaction of hypoglycemia was higher than in the corresponding placebo group (Table 3). Find patient medical information for sitagliptin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Side effects that may occur with Januvia include: Januvia (sitagliptin) is a brand-name prescription medication. Side effect Data for drug Placebo Labels 1: 2: Asthenia : uncommon, common x: x: … The most common side effect of sitagliptin is headaches. ).Some health conditions may make you more susceptible to the side-effects of the drug. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. Sitagliptin Side Effects: What Could Happen as Soon as You Start. Some side effects may go away as your body adjusts to the medicine. Call your doctor for medical advice about side effects. ([2015, Aug 28]): Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Description: Sitagliptin inhibits dipeptidyl peptidase IV (DPP-IV) enzyme resulting in prolonged active incretin levels.Incretin hormones, including glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic β-cells and decreasing glucagon secretion from pancreatic α-cells. Januvia (sitagliptin) is a brand-name prescription medication. 2. Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME-V study) Masaya Koshizaka1,2,KoIshikawa1,2, Ryoichi Ishibashi 2,3,YoshiroMaezawa1,2,KenichiSakamoto2, Daigaku Uchida4, Susumu Nakamura5, Masaya Yamaga 6, … Through Week 54, the overall incidence of hypoglycemia was 3.9% in patients given add-on JANUVIA and 1.0% in patients given add-on placebo. Sitagliptin oral tablet doesn’t cause drowsiness, but it can cause other side effects. Common side effects include headaches, swelling of the legs, and upper respiratory tract infections. vitamins, herbal supplements, etc. Common Questions and Answers about Sitagliptin side effects. Serious side effects are although rare, yet it is important to know that some patients have suffered from low blood sugar, pancreatitis, kidney abnormalities, and allergic reactions while taking this drug. Learn about side effects, dosage, generics, and more. This increase in WBC (of approximately 200 cells/microL vs placebo, in four pooled placebo-controlled clinical studies, with a mean baseline WBC count of approximately 6600 cells/microL) is not considered to be clinically relevant. Mean (SE) increases in serum creatinine were observed in patients treated with JANUVIA [0.12 mg/dL (0.04)] and in patients treated with placebo [0.07 mg/dL (0.07)]. Read the entire detailed patient monograph for Januvia (Sitagliptin Phosphate). Along with its needed effects, sitagliptin may cause some unwanted effects. Common side effects of Januvia include upper respiratory tract infection, headache, abdominal pain, nausea, and diarrhea. Find patient medical information for sitagliptin-simvastatin oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Merck & Company Inc, West Point, PA. 3. Common: constipation. Along with its needed effects, a medicine may cause some unwanted effects. Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. [Ref], 1. Januvia and the similar drug Janumet are two medications made by Merck to treat type 2 diabetes along with diet and exercise changes. In a pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the overall incidence of adverse reactions of hypoglycemia was 1.2% in patients treated with JANUVIA 100 mg and 0.9% in patients treated with placebo. Available for Android and iOS devices. Mis-diagnosed as T2 originally. Discontinue if symptoms of acute pancreatitis occur such as persistent, severe abdominal pain. Tell your doctor if you have serious side effects of Januvia including pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate), urinating less than usual or not at all, swelling, weight gain, shortness of breath, or 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). All drugs may cause side effects. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitors. Some side effects may not be reported. Additional adverse reactions have been identified during postapproval use of JANUVIA as monotherapy and/or in combination with other antihyperglycemic agents. Discontinue if symptoms of acute pancreatitis occur such as persistent, severe abdominal pain. No significant difference exists in the occurrence of hypoglycemia between placebo and sitagliptin. In an additional, 30-week placebo-controlled, study of patients with type 2 diabetes inadequately controlled with metformin comparing the maintenance of sitagliptin 100 mg versus withdrawal of sitagliptin when initiating basal insulin therapy, the event rate and incidence of documented symptomatic hypoglycemia (blood glucose measurement ≤70 mg/dL) did not differ between the sitagliptin and placebo groups. Remember to follow any advice you have been given about your diet. In controlled clinical studies as both monotherapy and combination therapy with metformin, pioglitazone, or rosiglitazone and metformin, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with JANUVIA were similar to placebo. In itself it doesn't cause hypos and only ever has a small effect. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be … In 22 cases, symptoms appeared within 1 month of starting therapy. "Product Information. Serious side effects can happen in people who take ONGLYZA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. However, many people have no side effects or only have minor side effects. januvia. The only side effect I had with Sitagliptin was low headache for a week. In the study of JANUVIA as initial therapy with pioglitazone, one patient taking JANUVIA experienced a severe episode of hypoglycemia. In the study of JANUVIA as add-on combination therapy with metformin and rosiglitazone, the overall incidence of hypoglycemia was 2.2% in patients given add-on JANUVIA and 0.0% in patients given add-on placebo through Week 18. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Common (1% to 10%): Hypoglycemia (when used in combination with insulin or sulfonylurea)[Ref], Common (1% to 10%): Abdominal pain, nausea, diarrhea, constipation, gastroenteritis, Postmarketing reports: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, vomiting, mouth ulceration, stomatitis[Ref], In a pooled analysis of 19 trials (sitagliptin 100 mg/day, n=5429; active control or placebo, n=4817), the incidence of acute pancreatitis was in 0.1 per 100 patient-years in each group (4 patients in each group)[Ref]. Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes during treatment with STEGLUJAN. Your doctor may change your diabetes treatment during pregnancy. Background: We investigated the effects of vildagliptin or alogliptin on blood glucose and hemoglobin A1c (HbA1c) in patients with type 2 diabetes inadequately controlled by sitagliptin. In these trials, patients with inadequate glycemic control on a stable dose of the background therapy were randomized to add-on therapy with JANUVIA 100 mg daily or placebo. Janumet (metformin and sitagliptin) is a prescription medication used to reduce blood glucose (sugar) levels in individuals with type 2 diabetes. Methods: In a single-center open-label trial, 35 patients with inad-equate glycemic control on sitagliptin … In 23 cases symptoms resolved less than 1 month after discontinuation. Taking sitagliptin/metformin with meals can help lessen the common stomach side effects of metformin that usually happen at the beginning of treatment. metformin, Trulicity, Victoza, Tresiba, Lantus, Levemir. You may report side effects to FDA at 1-800-FDA-1088. It’s used with diet and exercise to treat type 2 diabetes. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Check with your doctor immediately if any of the following side effects occur while taking sitagliptin: Breast feeding. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The more common side effects that can occur with sitagliptin … With drug discontinuation, supportive treatment and discontinuation of potentially causative agents, a return to baseline levels of renal insufficiency occurred. Efficacy and short-term side effects of sitagliptin, vildagliptin and saxagliptin in Chinese diabetes: a randomized clinical trial. Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. In those taking sulphonylureas, the risk of low blood sugar is increased. Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling). Hypoglycemia) Reported in ≥5% of Patients and More Commonly than in Patients Given Placebo, Before you start taking JANUVIA, tell your doctor if you've ever had pancreatitis. Incidence and Rate of Hypoglycemia* in Placebo-Controlled Clinical Studies when JANUVIA was used Two placebo-controlled monotherapy studies, one of 18-and one of 24-week duration, included patients treated with JANUVIA 100 mg daily, JANUVIA 200 mg daily, and placebo. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help. Janumet can also cause lactic acidosis, a dangerous condition in which lactic acid builds up to high levels in the blood. Renal impairment. If you have unusual or sudden stomach problems, talk with your doctor. Pioglitazone, Metformin + Rosiglitazone, or Glimepiride +/-Metformin: Adverse Reactions (Excluding Adverse Reactions Reported (Regardless of Investigator Assessment of Causality) in ≥5% of Patients Pregnancy may cause or worsen diabetes. Check with your doctor immediately if any of the following side effects occur: Less common. Many people using Januvia do not have serious side effects. In a pooled analysis of 19 double-blind clinical trials that included data from 10,246 patients randomized to receive sitagliptin 100 mg/day (N=5429) or corresponding (active or placebo) control (N=4817), the incidence of acute pancreatitis was 0.1 per 100 patient-years in each group (4 patients with an event in 4708 patient-years for sitagliptin and 4 patients with an event in 3942 patient-years for control). Janumet may trigger all of the same side effects because it also contains sitagliptin. The clinical significance of this added increase in serum creatinine relative to placebo is not known. In combination with glimepiride, with or without metformin, the overall incidence of clinical adverse reactions with JANUVIA was higher than with placebo, in part related to a higher incidence of hypoglycemia (see Table 3); the incidence of discontinuation due to clinical adverse reactions was similar to placebo. Side effects that may occur with Januvia include: Although Januvia by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if Januvia is prescribed with other anti-diabetic medications. It works by controlling levels of insulin which is produced by the body. Our Januvia (sitagliptin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Common (1% to 10%): Nasopharyngitis, upper respiratory infection, pharyngitis, Postmarketing reports: Interstitial lung disease[Ref], There have been postmarketing reports of serious hypersensitivity reactions in patients treated with this drug. Stomach problems that start later during treatment may be a sign of something more serious. Avoid—toxicity in animal studies. When combined with metformin it's … Many people using Januvia do not have serious side effects. Other important side effects of sitagliptin include: abdominal pain, nausea and; diarrhea. * Adverse reactions of hypoglycemia were based on all reports of symptomatic hypoglycemia; a concurrent glucose measurement was not required; intent-to-treat population. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. ).Some health conditions may make you more susceptible to the side-effects of the drug. The most common side effects of sitagliptin are: upper respiratory tract infection and; headache. Before taking ONGLYZA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels. The most common side effects of sitagliptin include: upper respiratory infection; stuffy or runny nose and sore throat; headache; stomach upset and diarrhea; STEGLUJAN may have other side effects including swelling of the hands or legs. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. ______________ is another term for type 2 diabetes. The most common Sitagliptin side effects include diarrhea, nausea and abdominal pains. Incidences of hypoglycemia are shown in Table 3. Zhou XJ(1), Ding L(1), Liu JX(1), Su LQ(2), Dong JJ(3), Liao L(1). Sitagliptin is also called by the brand name Januvia. In the United Kingdom it is listed as less preferred than metformin or a sulfonylurea. Some common side effects are: Headache; Loose motion; Stomach pain; Sore throat runny nose; Respiratory tract infection; These side effects are common and go away with time. Common side effects when taking JANUMET or JANUMET XR include stuffy or runny nose and sore throat, upper respiratory tract infection, diarrhea, nausea and vomiting, gas, upset stomach, indigestion, weakness, headache, and low blood sugar (hypoglycemia) when used in combination with certain medications, such as a sulfonylurea or insulin. In a pooled analysis of the two monotherapy studies, the add-on to metformin study, and the add-on to pioglitazone study, the incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA was as follows: abdominal pain (JANUVIA 100 mg, 2.3%; placebo, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%). Before using Sitagliptin, inform your doctor about your current list of medications, over the counter products (e.g. Across clinical studies, the incidence of laboratory adverse reactions was similar in patients treated with JANUVIA 100 mg compared to patients treated with placebo. Common side effects. In the 24-week study of patients receiving JANUVIA as add-on combination therapy with metformin, there were no adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients and more commonly than in patients given placebo. [Ref], Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, and exfoliative skin conditions including Stevens-Johnson syndrome[Ref], Postmarketing reports: Hepatic enzyme elevations[Ref], There have been postmarketing reports of worsening renal function, including acute renal failure, sometime requiring dialysis. Side effects are as common with sitagliptin (whether used alone or with metformin or pioglitazone) as they were with placebo, except for rare nausea and common cold-like symptoms, including photosensitivity. It is taken by mouth. Januvia (sitagliptin) is an oral diabetes medicine for people with type 2 diabetes (non-insulin-dependent) diabetes. pregnancy, upcoming surgery, etc. Learn more about Sitagliptin & Simvastatin The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Learn about side effects, dosage, generics, and more. On Levemir twice a day and NovoRapid for Bolus. BTW the Gliptins work by stopping an enzyme that blocks insulin production after a meal.

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