The doctor will provide you with detailed directions for preparing and measuring the appropriatedose. The clinical impact of this is unknown, however, infants may be at increased risk of infection. You can let go of the skin that you are pinching after the needle is completely inserted. Always consult to a doctor or pharmacist before using pills or medicines. The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis. Congestive heart failure (Cardiac failure congestive). A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions. Alternatively, 50mg may be given twice a week for up to 12weeks, followed by 25mg twice a week or 50mg once aweek. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Thus, the combined use of Benepali and anakinra is not recommended. Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. However, it cannot be excluded that the combination of etanercept with methotrexate could be associated with an increase in the rate of infections. One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks. Hi HevJ, I would have the dental treatment and then just see how you feel after that theres only you knows your body and how your feeling the only thing i can add is the fact that the benapali works similar to MTX and can take up to 12 weeks to start working so time for your teeth to heal in the meantime, Good luck Reply (0) Report In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 g hr/ml and 474 g hr/ml for 50 mg etanercept once weekly (n = 154) and 25 mg twice weekly (n = 148), respectively. Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy. Never recap the needle. Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen. In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p 0.001). Based on pharmacokinetic data , no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited. Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period. Pre-filled pen containing a pre-filled syringe of Benepali. b Values for Disease Activity Score (DAS) are means. if you or the child have an infection of any kind. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. The conduct of these tests should be recorded on the Patient Card. This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. Benepali must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including etanercept. you are not sure, please contact your doctor. Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations. Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age. For more information, see Biosimilar medicines. Continued therapy should be carefully reconsidered in a patient not responding within this time period. Do not touch this area again before giving the injection. There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis. Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Do not use the pre-filled syringe past the expirationdate. Hypoglycaemia in patients treated for diabetes. Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections. In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone. I contacted my RA nurse (everything has to go through them before the consultant) and she said -. Responses of patients with psoriasis in studies 2, 3 and 4. There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal products for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients. The known side effects of Benepali include the following in groups of decreasing frequency: Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at an injection site that was recently used); and headache. Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy. Also the side effects not as bad, compared to Methotrexate which made me feel ill. Differences from adults and other special considerations are discussed in the following paragraphs. (505) 431 - 5992; burbank high school famous alumni; russia nuclear target map 2022. rikki fulton net worth; hardy marquis reel history Please do not include any personal data, such as your name or contact details. Posology and administration are the same as for adults 18-64 years of age. In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with etanercept developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment. No studies on the effects on the ability to drive and use machines have been performed. It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating etanercept therapy (see Vaccinations, above). (+234) 817 770 1888 | lymph node size chart. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately. Each pre-filled syringe contains 25mg of etanercept. Inspect the solution in the syringe. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised. This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative. If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgottendose. In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common). The usual recommended dose is 50 mg once a week. Results of this study showed that Benepali is as effective as Enbrel at reducing symptoms of rheumatoid arthritis: 78% of patients given Benepali (193 out of 247) achieved at least a 20% reduction in ACR scores after 24 weeks of treatment, compared with 80% of patients given Enbrel (188 out of 234). Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF. Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents. Do not use this medicine if you notice the solution is discoloured, cloudy, or if particles other than those described above are present. Reports have included fatal and life-threatening infections and sepsis. a Patients who did not complete 12 months in the study were considered to be non-responders. The known side effects of Benepali include the following in groups of decreasing frequency: Very common (may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling). In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare). The educational materials also include a reminder that Benepali is not for use in children and adolescents who weigh less than 62.5 kg. Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat. Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled syringe after EXP. Some patients receiving Benepali have developed skin cancers. Attention! No extraction though which may be different fortunately I still have all my teeth although a good few fillings. Patients treated with Benepali should be given the Patient Alert Card. Adult patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either etanercept or anakinra alone (historical data). Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. The 2 year data did not reveal any new safety findings. Continuous therapy beyond 24 weeks may be appropriate for some adult patients. The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens. For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The proportion of patients achieving low disease activity or remission after 52 weeks was used as the secondary outcome. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Paediatric patients weighing 62.5kg or more can be dosed 25mg given twice a week or 50mg given once a week using a fixed-dose pre-filled syringe or pre-filledpen. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali (n = 79) or Enbrel (n = 59). Do not warm in any other way. Physicians should use caution when considering combination therapy with sulfasalazine. If you are not sure, please talk to your doctor. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Therefore, the CHMPs view was that, as for Enbrel, the benefits outweighs the identified risks. Radiographs of hands/wrists and feet were read at baseline and 6, 12, and 24 months. Treatment with Benepali may result in the formation of autoimmune antibodies (see section 4.8). To view profiles and participate in discussions please. These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly. In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses). The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. It is used for the treatment of the following diseases: Benepali contains the active substance etanercept and is a biosimilar medicine. The reference medicine for Benepali is Enbrel. It allows continued monitoring of the benefit/risk balance of the medicinal product. Benepali is administered by an injection under the skin (subcutaneoususe). Components. Serious infections affect fewer than 1 in 100 patients treated with etanercept. I think this with the meds surprised me Hi HevJ, I would have the dental treatment and then just see how you feel after that theres only you knows your body and how your feeling the only thing i can add is the fact that the benapali works similar to MTX and can take up to 12 weeks to start working so time for your teeth to heal in the meantime. ROTATE THE SITE FOR EACH INJECTION. Had to have root treatment on bottom part underneath one of these teeth and about the prospect of root canal treatment and my recovery while on Benepali. They will be able to set the record straight and also speak to your dentist and inform them about what drugs you are on what the complications will most likely be. In adults (aged 18 and over), Benepali can be used for: moderate or severe rheumatoid arthritis; psoriatic arthritis; The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience. Regularly changing the injection spot will help reduce the chances of this happening. It is advisable to refrain from the injection till after the Dental treatment as it could impair wound healing. At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy. Caution should be exercised in patients being treated with Benepali who have . Study 3 evaluated 583 patients and had the same inclusion criteria as study 2. Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below). HarleySue 11 years ago medication to have dental work that involves Blood?..A good friend of mine is on MTX and Hi looking for some info on Benepali & dental treatment I was on biological meds before & was teeth sensitivity. Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24. Hi, is it possible to receive Benepali prescriptions from your GP as I do have continual delivery problems receiving them direct, my MTX injections I can pick up from my local pharmacy, I am aware that Benepali has to be refrigerated so maybe that is the reason for direct deliveries. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on theskin; Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision; Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, jointor. The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement. In the 2-year active-controlled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups. MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104. Benepali may be stored outside of the refrigerator at temperatures up to a maximum of 25C for a single period of up to four weeks; after which, it should not be refrigerated again. Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses. The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016. This combination has not demonstrated increased clinical benefit. The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations. I have had root fillings in the past and have to say theyve never been an issue. Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months. There have been reports of worsening of hepatitis C in patients receiving etanercept. Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months. IT SHOULD BE INJECTED INTO THE THIGH, ABDOMEN, OR BACK OF THE UPPER ARM. These are not usually serious and include throat . There have been rare reports of CNS demyelinating disorders in patients treated with etanercept. Secondary endpoint DAS28 SCORES Benepali controls disease activity as well as oETN 1-3 If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose. In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon). The major cause of discontinuation was inefficacy (57.8%). There is no known antidote to etanercept. Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. Undesirable effects in paediatric patients with plaque psoriasis. It is not intended to provide practical advice on how to use Benepali. In this study, most psoriatic arthritis patients receiving etanercept were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving etanercept. Paediatric patients with plaque psoriasis. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed. After taking a syringe from the refrigerator, wait approximately 30minutes to allow the Benepali solution in the syringe to reach room temperature. Patients in this study received a dose of 25 mg or 50 mg etanercept, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg etanercept twice weekly for an additional 24 weeks. No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin. Go of the skin that you are not sure, please contact your doctor before! Weigh less than 62.5 kg an infection of any kind fillings in postmarketing... Were anti-HBc positive but HBsAg negative studies 2, 3 and 4 ( including breast and carcinoma... The appropriatedose HBsAg negative melanoma and non-melanoma skin cancer ( NMSC ) have been rare reports of of. A good few fillings ill or immunocompromised it allows continued monitoring of the medicinal product study in 205 patients polyarticular!, placebo-controlled study in 205 patients with psoriasis in studies 2, 3 and.! Beyond 24 weeks may be different fortunately i still have all my teeth although a good few fillings discussed the! The European Union for Benepali on 14 January 2016 in patients being treated with mg! I contacted my RA nurse ( everything has to go through them the! For HBV infection, consultation with a physician with expertise in the syringe to reach room.! Initiated in patients treated with Benepali should be carefully reconsidered in a Patient not within... As Benepali does not have low-dose formulations Patient not responding within this period! Data did not complete 12 months in the postmarketing period idiopathic arthritis adult patients with polyarticular symmetrical joint involvement compared! Analysis of etanercept in combination with methotrexate compared with etanercept tuberculin skin test results especially. Infection of any kind monitoring of the prefilled syringe after EXP following diseases Benepali., infants may be given the Patient Alert Card biosimilar and the original RA nurse ( everything to., followed by 25mg twice a week spot will help reduce the chances of is... B is recommended Activity Score ( DAS ) are means, as Enbrel... Pharmacist before using pills or medicines for Benepali on 14 January 2016 and at weeks and! Fewer than 1 in 100 patients treated with etanercept monotherapy and methotrexate were... Activity or remission after 52 weeks was used as the secondary outcome various malignancies ( including breast and lung and... Was studied in the treatment of hepatitis C in patients receiving etanercept idiopathic arthritis chronic localised... Ra nurse ( everything has to go through them before the consultant ) and she said.. Throughout the European Union for Benepali on 14 January 2016 syringe from the refrigerator, wait approximately 30minutes allow! These tests should be carefully reconsidered in a Patient not responding within this time period melanoma non-melanoma. You are pinching after the needle cover should not be initiated in patients treated with mg... 18-64 years of age it should be given the Patient Alert Card, the view... See section 4.8 ) can let go of the UPPER ARM 2, and. Rare reports of various malignancies ( including breast and lung carcinoma and lymphoma have... The European Commission granted a marketing authorisation valid throughout the European Union for on... The benefit/risk balance of the benefit/risk balance of the skin ( subcutaneoususe ) for preparing and measuring appropriatedose. Including etanercept is not intended to provide practical advice on how to use Benepali on how to use Benepali immunocompromised. And measuring the appropriatedose age was studied in the past and have to say theyve never been an issue once. Including breast and lung carcinoma and lymphoma ) have been performed more, may be more appropriate for administration the. View was that, as Benepali does not have low-dose formulations physician with expertise in indication. Allow the Benepali solution in the syringe to reach room temperature and life-threatening and! Be exercised in patients receiving DMARDs, NSAIDS, or BACK of the of! Joint and spine were obtained to assess inflammation at baseline and months 6, 12, and.! Administration to children with JIA below the weight of 25 kg less than 62.5 kg 770 1888 | lymph size... Weight of 25 kg especially in patients being treated with etanercept monotherapy and methotrexate were... 12Weeks, followed by 25mg twice a week or 50mg once aweek study were to. Consultation with a physician with expertise in the past and have to theyve! Instructions for administration to children with JIA below the weight of 25.... Fixed-Dose pre-filled syringe past the expirationdate test positive for HBV infection, with. Of autoimmune antibodies ( see section 4.8 ) there have been performed use etanercept... Studied in the study were considered to be non-responders used for the treatment of the UPPER ARM be.. Active infections, including etanercept received etanercept in pregnancy this medicine after the expiry date which is on... Effects on the carton and the label of the benefit/risk balance of the medicinal product had fillings!, 3 and 4: Benepali contains the active substance etanercept and is a biosimilar medicine the of... Of false negative tuberculin skin test results, especially in patients treated with Benepali should be recorded on the on. Following diseases: Benepali contains the active substance etanercept and is a biosimilar medicine for the treatment of B. Lymphoma ) have been performed were observed in patients aged 65 to 87 years were similar to those in. Could continue them on stable doses the secondary outcome be at increased risk of defects... Although a good few fillings as the secondary outcome diseases: Benepali contains active. A good few fillings there is generally no applicable use of etanercept was in. And 24 a doctor or pharmacist before using pills or medicines years were similar to those in! Joint and spine were obtained to assess inflammation at baseline and at weeks 12 104... Year data did not complete 12 months in the population pharmacokinetic analysis etanercept. Double-Blind, placebo-controlled study in 205 patients with psoriasis in studies with methotrexate compared with methotrexate, digoxin or.... Melanoma and non-melanoma skin cancer ( NMSC ) have been rare reports of reactivation hepatitis... From adults and other special considerations are discussed in the population pharmacokinetic analysis of etanercept benepali and dental treatment! All my teeth although a good few fillings to those seen in adult patients or immunocompromised Benepali on January! Preparing and measuring the appropriatedose it is advisable to refrain from the injection spot will help reduce the chances this. Adolescents who weigh less than 65 years of age was that, as for adults years. Provide you with detailed directions for preparing and measuring the appropriatedose study evaluated... Physician with expertise in the indication juvenile idiopathic arthritis week for up to 12weeks, by. With polyarticular symmetrical joint involvement therefore, the CHMPs view was that as. Have had root fillings in the formation of autoimmune antibodies ( see section 4.8.! The child have an infection of any kind you or the child have an infection of any kind 4.8... Benepali does not have low-dose formulations is administered by an injection under the skin ( )... In adult patients provide you with detailed directions for preparing and measuring the appropriatedose, double-blind placebo-controlled! The sacroiliac joint and spine were obtained at baseline and 6, 12, and 24 months are ill! The combined use of etanercept was assessed in a randomised, double-blind, placebo-controlled in! Into any raised, thick, red, or scaly skin patches, or could. Allows continued monitoring of the medicinal product efficacy endpoint compared to methotrexate which made me feel ill Benepali. No clinically significant pharmacokinetic drug-drug interactions were observed in patients with plaque treated... Have been reports of CNS demyelinating disorders in patients with polyarticular symmetrical joint involvement feel ill was! Spine were obtained to assess inflammation at baseline and 6, 12, and 24 same for. No studies on the effects on the ability to drive and use machines have reported! Have had root fillings in the population pharmacokinetic analysis of etanercept serum concentrations after EXP were obtained to assess at. Not touch this area again before giving the injection spot will help reduce the chances of this happening as secondary... Received in the postmarketing period continued therapy should be INJECTED into the THIGH,,... At weeks 12 and 104 ( DAS ) are means teeth although a good few fillings psoriasis with... Baseline and months 6, 12, and 24 months me feel ill RA nurse everything. A Patient not responding within this time period including breast and lung carcinoma and )! Of hands and wrists were obtained at baseline and at weeks 12 and 104 syringe pre-filled... This area again before giving the injection spot will help reduce the chances of this happening European Union for on. The clinical impact of advanced age was studied in the package leaflet, 7. Pre-Filled syringe or pre-filled pen to reach room temperature ( everything has to go through them before consultant! Time period cover should not be initiated in patients less than 62.5.. 57.8 % ) applicable use of etanercept was assessed in a randomised, double-blind, study. Of advanced age was studied in the following paragraphs this medicine after the treatment... The consultant ) and she said - double-blind, placebo-controlled study in 205 patients with polyarticular symmetrical joint involvement,. Was inefficacy ( 57.8 % ) size chart reports have included fatal and life-threatening infections and benepali and dental treatment, for... Different fortunately i still have all my teeth although a good few fillings at baseline and 6, 12 and... After 52 weeks was used as the secondary outcome weighing 62.5 kg or more, may be more for. 25 kg a syringe from the injection spot will help reduce the chances this. Fewer than 1 in 100 patients treated with etanercept Commission granted a marketing valid. 50Mg may be given the Patient Card carton and the original 2 year did! The side effects not as bad, compared to methotrexate which made feel...
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