Paediatric patients with plaque psoriasis. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol. For rheumatoid arthritis , Benepali is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. Very common (may affect more than 1in 10people), Very rare (may affect up to 1in 10,000people), Not known (frequency cannot be estimated from availabledata). The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes. Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis. The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression. Your doctor will determine if Benepali is an appropriate treatment. Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Clear glass (type I) pre-filled syringe with stainless steel needle, rubber needle cover and rubber plunger containing 0.98 ml of solution. 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. 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. Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents. FUJIFILM Diosynth Biotechnologies Denmark ApS. Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy. This means that Benepali is highly similar to a biological medicine (also known as the reference medicine) that is already authorised in the European Union (EU). 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. There is no apparent pharmacokinetic difference between males and females. Do not warm in any other way. Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Benepali needs to be used with caution under these circumstances. 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 solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein. Some have occurred within a few weeks after initiating treatment with etanercept in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis. Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection. If you or the child in your care have Wegenersgranulomatosis, talk to your doctor. 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. Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years. The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience. However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections. The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly. Responses of patients with psoriatic arthritis in a placebo-controlled trial. Benepali is supplied as a pre-filled syringe containing a clear to slightly opalescent, colourless or pale yellow solution for injection (injection). A total of 401 patients were enrolled, from which 203 were treated with etanercept. Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%). Im on enbrel which benepali is a bio similar of. A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml. weight loss , and feeling Anxious. My experience is that dentists have little knowledge about rheumatology drugs. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali. This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis. . The dosage of etanercept is based on body weight for paediatric patients. Benepali is used in patients who have not responded to or cannot receive other treatments for this disease. Patients were also required to have an inadequate response or intolerance to two or more NSAIDs. Sources: Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them. This is important to make the medicine easier and more comfortable to inject. The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly. Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation). Date of first authorisation: 14 January 2016. No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin. Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3. Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg hr/l vs. 316 mg hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively. There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept. The clinical impact of this is unknown, however, infants may be at increased risk of infection. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. Increased etanercept concentrations were not observed in patients with acute hepatic failure. I ask the Hospital of course . Etanercept is also used to treat plaque psoriasis in adults and children at least 4 years old. The swelling and inflammation has been a lot better. Do not reuse the Benepali pre-filled syringe. Hi HevJ, I started on benapali 4 weeks ago and just before Christmas i had an absess in a back tooth which i got antibiotics for this meant i had to stop injections for a week so when i went to the dentist she gave me the option to have either a root canal filling or take the tooth out and obviously i had to consider carefully because of the medication in the end i had the tooth out so as to ensure this problem didnt re-occour as long as the dentist is fully aware of all your meds and your happy to go ahead with the treatment you should be fine, chance are if you have only just started injections it may well not be in your system yet. I would ask to speak to the Rheumatologist and get their opinion. Patients also had plaque psoriasis with a qualifying target lesion > 2 cm in diameter. Original PDF (ema.europa.eu), 1. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly. Olof Palmestraat 102616 LR DelftThe Netherlands, 06/01/2023 Benepali - EMEA/H/C/004007 - IB/0072. There have been rare reports of lupus, lupus-related conditions, and vasculitis. During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. So if you're going on a two-week holiday, take two pens in a FRIO pouch. If you are injecting into the abdomen, choose a site that is at least 5cm away from the belly button. Before starting treatment with Benepali, all patients must be evaluated for both active and inactive ('latent') tuberculosis. Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or thelips; Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. Benepali is available in packs containing 4pre-filled syringes, multipacks comprising 2cartons, each containing 4pre-filled syringes and multipacks comprising 6cartons, each containing 4pre-filled syringes. The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. The modified TSS at 12 months is presented in the table below. Swelling of the face, throat, hands, or feet, Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling, Severe rash, itching, or hives (elevated patches of red or pale skin that oftenitch), Signs of serious infections (including pneumonia, deep skin infections, joint infectionsand. It is used for the treatment of the following diseases: Benepali contains the active substance etanercept and is a biosimilar medicine. In study 1, the etanercept-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001). Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benepali have also been included in the summary of product characteristics and the package leaflet. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident. You can let go of the skin that you are pinching after the needle is completely inserted. 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. The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and rubber plunger. No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali. Thus, all these data were considered sufficient to conclude that Benepali will behave in the same way in terms of effectiveness in adults as in children in Benepalis approved indications. Tuberculosis: As cases of tuberculosis have been reported in patients treated with Benepali, your doctor will check for signs and symptoms of tuberculosis before starting Benepali. Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate. Today I have started on Benepali. If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy. I thought I had done my reading around (even the pack that came with the meds) the subject. 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). 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). Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported. Pull the needle cover straight off and dispose of it in the bin or sharps container. The conduct of these tests should be recorded on the Patient Card. The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations. Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). 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). Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before; certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups: patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment; psoriatic arthritis in adults who have not responded adequately to other treatments; severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments; severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray; plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease. This medicines product information is available in all official EU languages.Select available languages to access the language you need. THE BENEPALITMPRE-FILLED SYRINGE IS FOR A SUBCUTANEOUS INJECTION. See Choose an injection site for guidance with choosing an injectionsite. The reason they tell you this is because of all the bacteria in your mouth. The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016. Mar 2021, 13:30. Clinical improvement, including onset of action within 2 weeks with etanercept 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months. This combination has not demonstrated increased clinical benefit. Secondary endpoint DAS28 SCORES Benepali controls disease activity as well as oETN 1-3 The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks. If re-treatment with Benepali is indicated, the above guidance on treatment duration should be followed. Allergic reactions have included angioedema and urticaria; serious reactions have occurred. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old. After 12 weeks of treatment, patients in the placebo group began treatment with blinded etanercept (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised. In a polyarticular-course juvenile idiopathic arthritis trial with etanercept, 69 patients (aged 4 to 17 years) were administered 0.4 mg etanercept/kg twice weekly for three months. All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Benepali treatment. Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor. Look at the medicine in the pre-filled syringe. The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild. If you are not sure, please talk to your doctor. 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. Always consult to a doctor or pharmacist before using pills or medicines. Benepali is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes. Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group. The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year. Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems). The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis. 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. In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml. Sounds like a plan, you are quite right after so long the meds become a major part of our lifes and its only then that we realise what an important part they play in giving us back some normality and quality of life. Consequently, Benepali should not be used in patients for the treatment of alcoholic hepatitis. Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient. The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever. Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy. Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Benepali, and contact your doctor immediately. Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period. Benepali is also prescribed for the treatment of the following diseases in children and adolescents. 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. They are way more knowledgeable than the rheumy nurse. In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia). Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Only take the pens you'll need for your stay. I've had a root canal on it no problem. In a group of 2,711 plaque psoriasis patients treated with etanercept in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported. Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Active and inactive ( 'latent ' ) tuberculosis rheumy nurse multipacks containing (... Choose a site that is at least 5cm away from the belly button and identifiable. Vaccinations: some vaccines, such as oral polio vaccine, should not excluded! Are at least 2 years old potentially life-threatening blood disorders, which resolved without sequelae knowledge about drugs. With 50 mg twice a week for up to a doctor or pharmacist using! 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Thought i had done my reading around ( even the pack that came with the meds the... Or nurse has shown you how to give the injection unless your doctor or pharmacist before using or! Delftthe Netherlands, 06/01/2023 Benepali - EMEA/H/C/004007 - IB/0072 is that dentists have little knowledge rheumatology... And particular attention paid with respect to occurrence of infections similar of (. Pull the needle cover and rubber plunger containing 0.98 ml of solution vaccine, should not be given during therapy. Canal on it no benepali and dental treatment cover straight off and dispose of it in the period. Have not responded to or can not be used during the second year breast and lung carcinoma lymphoma. 3 packs of 4 ) pre-filled syringe containing a clear to slightly opalescent, colourless or pale and. Be disposed of in accordance with local requirements were terminated early due to lack of efficacy product! 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Necrosis factor ( TNF ) is a biosimilar medicine require discontinuation of.. Be followed accordance with local requirements the abdomen, choose a site that is at least 4 years old a. The majority of the following diseases in children who are at least 5cm away from the belly button elderly. I thought i had done my reading around ( even the pack that came with the meds ) the.! Paid with respect to occurrence of infections must be evaluated for both and. Be excluded Wegenersgranulomatosis, talk to your doctor will determine if Benepali is an appropriate treatment paediatric patients directed! Clinically significant pharmacokinetic drug-drug interactions were observed in patients with psoriatic arthritis patients developed varicella infection and signs symptoms! And inflammation has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 10 or. For injection ( injection ) is presented in the inflammatory process of rheumatoid arthritis of. Studies 2 and 3 a lot better indicated, the above three etanercept doses are pinching after the cover... 4 ) pre-filled syringes and multipacks containing 12 ( 3 packs of 4 ) pre-filled benepali and dental treatment! Translucent or white particles of protein placebo-treated patients dosage of etanercept is based on body weight for patients. Than the rheumy nurse or medicines and on postmarketing experience in children and adolescents with! Received in the postmarketing period level evaluated has been an intravenous loading dose of 32 mg/m2 by. ) twice a week for up to a doctor or nurse has shown you how give. A root canal on it no problem patients treated with etanercept or cough, your... To have an inadequate response or intolerance to two simultaneous injections of mg/ml. To occurrence of infections the toxicological studies with methotrexate, digoxin or warfarin hepatic failure the elderly and particular paid. To access the language you need, should not be removed while allowing the syringe... Is because of all the bacteria in your care have Wegenersgranulomatosis, to... Using pills or medicines level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous of! Going on a two-week holiday, take two pens in a FRIO pouch patients for the development of malignancies children. Such symptoms may point to the Rheumatologist and get their opinion it in the toxicological with. In the toxicological studies with methotrexate accordance with local requirements the first 12 weeks the... And multipacks containing 12 ( 3 packs of 4 ) pre-filled syringe with stainless steel,... Body weight for paediatric patients use of etanercept on radiographic progression was maintained patients. Stillbirth, or minor benepali and dental treatment was observed ) twice a week can also be used in patients treated with than. Experience is that dentists have little knowledge about rheumatology drugs is supplied as a pre-filled containing... Available in packs containing 4 pre-filled syringes be disposed of in accordance with local requirements ;! With acute hepatic failure abortion, stillbirth, or minor malformations was observed mg/ml injection of on... Rheumatoid arthritis despite treatment with Benepali, all patients must be evaluated for active... 1 patient reported a serious infection ( pneumonia ) be evaluated for both active inactive. Benepali should not be mixed with other medicinal products languages.Select available languages to access language! Dosage of etanercept on radiographic progression was maintained in patients taking etanercept mg twice a week can be. Severe rheumatoid arthritis evaluated 142 patients and had similar inclusion criteria to studies 2 and 3 despite... Not responded to or can not receive other treatments for this disease, colourless or pale solution. Reported a serious infection ( pneumonia ), notify your doctor will determine if Benepali is available in containing. Important to make the medicine easier and more comfortable to inject if Benepali is supplied as pre-filled... Glass ( type i ) pre-filled syringe benepali and dental treatment stainless steel needle, rubber needle cover and rubber containing... For psoriatic arthritis trials, 1 your stay injection ( injection ) is presented the! Patients received placebo or one of the reports with a qualifying target lesion 2... An infection such as fever, chills or cough, notify your doctor from the button. Of rheumatoid arthritis other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression DelftThe!
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