Sidenote: I later found out that a pharmacy next door Farmacia de Paris, is actually a historic spot from 1944 that continues to develop more than 100 remedies on site. 3. # Al menos una de estas reacciones adversas fue notificada como grave. I have that card now, and unfortunately no - that won't work, because you cannot use this card to pay for the medicine abroad. h SF-36 MCS = Cuestionario de salud abreviado de 36 tems para el estudio de los resultados mdicos, resumen del componente mental. Do you happen to know anything about Tremfya? Se permiti el uso de corticoesteroides tpicos de baja potencia en la cara, axilas e ingles, y el uso de champ de alquitrn de hulla y/o preparados de cido saliclico para piel cabelluda durante los estudios. Descripcin de reacciones adversas seleccionadas: En los estudios clnicos y la experiencia poscomercializacin, se registraron casos poco frecuentes de ideacin y comportamiento suicida, mientras que los casos de suicidio consumado slo se notificaron en el mbito poscomercializacin. These medications may be counterfeit and potentially unsafe. You are encouraged to report negative side effects of prescription drugs to the FDA. Se observaron respuestas ACR similares en los pacientes con diferentes subtipos de artritis psorisica, incluida la artritis en las articulaciones IFD. In vitro, apremilast es un sustrato y un inhibidor dbil de la glicoprotena P (P-gp) (CI50 > 50 M); sin embargo, no se espera que ocurran interacciones medicamentosas clnicamente relevantes mediadas por la P-gp. Quite often tourists and locals go to Mexico just to buy medicines, as theyre available over the country and are much cheaper. My skin partially cleared up and before Matt and I left Mexico we were able to stock up on more boxes. Just yourself, nothing ;-) Pacientes de edad avanzada: No se requiere un ajuste de la dosis en esta poblacin de pacientes. Otezla is also used to treat: mouth sores in people with Behcet's disease Humira is also used to treat: ankylosing spondylitis Crohn's disease hidradenitis suppurativa juvenile idiopathic. El criterio principal de valoracin fue el porcentaje de pacientes que obtuvieron una respuesta ACR20 en la semana 16 conforme a los criterios del Colegio Americano de Reumatologa (ACR por sus siglas en ingls, American College of Rheumatology). If you have certain medical conditions, your doctor may recommend that you use Otezla. To the extent, there were 3 pharmacies at one intersection, one of which was the one I was looking for Farmacia Especializada. Tell your doctor about any side effect that bothers you or does not go away. In vitro, apremilast no es un inhibidor ni un inductor de las enzimas del citocromo P450. Adems, en el estudio ESTEEM 1 se alcanz una mejora significativa en el cuestionario de limitaciones laborales (WLQ-25 por sus siglas en ingls, Work Limitations Questionnaire) en los pacientes tratados con apremilast, en comparacin con los tratados con placebo. La exposicin en los sujetos de edad avanzada (de 65 a 85 aos) es alrededor de un 13% mayor en el AUC y alrededor de un 6% mayor en la Cmx para apremilast que en los sujetos jvenes (de 18 a 55 aos). Biotransformacin: Apremilast se metaboliza extensamente por las vas mediadas por CYP y no mediadas por CYP, incluidas las vas de oxidacin, hidrlisis y conjugacin, lo que sugiere que no es probable que la inhibicin de una nica va de aclaramiento cause una interaccin medicamentosa destacable. La exposicin de apremilast se reduce cuando se administra de forma concomitante con inductores potentes de CYP3A4 (p. A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. Third: Your existing pharmacy may offer to help you file your application. Methods of treating, managing or preventing diseases ameliorated by inhibiting PDE4 such as psoriasis, ankylosing spondylitis, Behcet's disease, rheumatoid arthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis are disclosed. En caso de una prdida de peso . ej., rifampicina, fenobarbital, carbamazepina, fenitona y hierba de San Juan) junto con apremilast. No se dispone de datos. Plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Sarah's plaque psoriasis made her want to hide her skin. Have you checked the Janssen program? Si est cerca de la hora de la siguiente dosis, no se debe tomar la dosis olvidada sino que se tomar la siguiente dosis a su hora habitual. Otezla Apremilast is used to treat plaque , , and certain oral ulcers.. Answered in 1 hour by: 3/16/2017. The lowest price on PharmacyChecker.com for Otezla 30 mg is $19.52 per tablet for 168 tablets at PharmacyChecker-accredited online pharmacies. Los sujetos sin datos contaron como no respondedores. I specifically said only, because in the US since January 1st 2019 when pharmaceutical companies increased prices, the retail priceof a supply of 0.5 milliliters ofStelarais around $10,770. Upon my arrival in Mexico City I checked the pharmacy website in the morning to see if Stelara is available It was. Specific methods encompass the administration of apremilast, alone or in combination with a second active agent. Even though Ive lived in Mexico City before and wandered around Zocalo (historic center) a bunch of times, I never noticed a whole street filled mostly with pharmacies. Se observaron mejoras en las semanas 16 y 24 en los parmetros de la actividad perifrica caracterstica de la artritis psorisica (p. I received Stelara packed perfectly in a big cooler. Ver la advertencia adicional para los pacientes con un peso inferior al normal al inicio del tratamiento. Oral ulcers associated with Behet's Disease. Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its () isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. La mediana de duracin de la artritis psorisica fue de 5 aos. I thought that mywill to live just like any other human without a chronic disease was strong enough, and while mentally it was, physically my body didnt really get the memo. Upon my research and help of my friends, I was able to get a confirmation that I could get a prescription for Stelara, assuming Im paying for the drug itself out of pocket. Here's a list of drugs that are likely available at a Mexico pharmacy. While I have realized that theres no cure and I must live with it, I actually didnt even think about it. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. OTEZLA (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). Insuficiencia heptica: La farmacocintica de apremilast y la de su principal metabolito M12 no se ven afectadas por la insuficiencia heptica moderada o grave. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Apremilast no fue clastognico en un ensayo de microncleos en ratn in vivo con dosis de hasta 2000 mg/kg/da. Se observaron tasas de respuesta similares en todos los intervalos de peso. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Speaking from my experience with European public insurances (which nota bene arent free as Americans like to state, because your employer actually pays for it out of your payslip), I remember even my family members waiting 2 years for surgery or over 6 months for a specialist visit and yes, that also includes oncologists. Los pacientes tratados con placebo que fueron considerados no respondedores fueron reasignados aleatoriamente en una proporcin 1:1, de forma enmascarada, a 20 mg o a 30 mg de apremilast dos veces al da. Artritis Psorisica: Est indicado para el tratamiento de artritis psorisica activa (PsA) en pacientes adultos. About Otezla (apremilast) OTEZLA (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). The old forms (asking the net worth question) are still floating around so be sure to get the newest application form. Otezla can cause allergic reactions, sometimes severe. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. At least it always worked for me. receiving Otezla continued on the assigned therapy for an additional year). treatment with Otezla. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. Se puede administrar apremilast de forma concomitante con anticonceptivos orales. Although there is an approved generic version of Otezla, it is not currently available on the market. Estudios de genotoxicidad: Apremilast no es genotxico. PDE4 inhibition results in increased intracellular cAMP. The content of the linked site is the sole responsibility of the site provider. Al navegar por este sitio web usted comprende que accede al empleo de estas cookies. Otezla SupportPlus is a suite of services specifically designed to provide savings and support for people being treated with Otezla.*. Se observ un aumento del nmero de muertes perinatales y posnatales de las cras y una reduccin en la ganancia de peso de las cras durante la primera semana de lactancia con dosis 80 mg/kg/da ( 4,0 veces la exposicin clnica). Insanely expensive even with my Medicare and secondary insurance coverage really cost prohibitive! La respuesta a apremilast fue rpida, con mejoras significativamente mayores en los signos y sntomas de la psoriasis, incluido el PASI, malestar/dolor en la piel y prurito, en comparacin con placebo en la semana 2. Amgen's purchase of Otezla strengthens the company's long-standing immunology portfolio, including TNF inhibitor, Enbrel, which has been approved in RA for over two decades and also holds a dual. Please click here for the Full Prescribing Information for Otezla. treatment. By visiting different doctors in public and private sectors in Poland, United Kingdom, United States, Netherlands or Mexico I saw that dermatologists simply arent always able to follow up with every single new drug for psoriasis that comes out. Lase instructivo anexo. Tabla 4. Write it below in the comment section. No hubo interacciones medicamentosas clnicamente significativas entre ketoconazol y apremilast. Aproximadamente un tercio de los pacientes no haba recibido fototerapia previa ni tratamiento sistmico convencional o biolgico previo. Entre los pacientes que fueron inicialmente aleatorizados al tratamiento con 30 mg de apremilast dos veces al da, el cambio con respecto a la situacin basal en la puntuacin en HAQ-DI en la semana 52 fue de 0,333 en el grupo de 30 mg de apremilast dos veces al da en un anlisis agrupado de la fase abierta de los estudios PALACE 1, PALACE 2 y PALACE 3. It was expensive and required me to work from home for a day. Specialty Drug: Specialty drugs are often expensive and may need to be filled through specialty pharmacies. PDE4 inhibition results in increased intracellular cAMP. Resumen del perfil de seguridad: Las reacciones adversas notificadas con mayor frecuencia en los estudios clnicos de fase III fueron trastornos gastrointestinales (GI) que incluyen diarrea (15,7%) y nusea (13,9%). Once I settled in Mexico I researched all my options. Otezla was first approved for the treatment of psoriatic arthritis on March 21st, 2014 by the FDA and was on the market soon after (by the end of March 2014). I want to show that you dont have to be ultra rich or have a travel partner to do it! Available for Android and iOS devices. At 20, I embarked on a mission to see the world while building my career through studying and working abroad. Un total del 18% de los pacientes tena historia de artritis psorisica. En los ratones, el NOEL en el desarrollo y en la madre fue de 10 mg/kg/da (1,3 veces la exposicin clnica). 5. With Otezla, she's found hope again. I've been on Medicare (retied senior) for the past five years and this year AbbieVie, through my dermatologist and pharmacy, offered my prescription FREE to me. Despus de la titulacin inicial de la dosis, no es necesario una re-titulacin de la dosis. El metabolismo oxidativo de apremilast est mediado principalmente por CYP3A4, con alguna contribucin menor de CYP1A2 y CYP2A6. Tell your doctor if any of these conditions occur. En general, se alcanzaron las respuestas en el PASI en la semana 16 y se mantuvieron hasta la semana 32. Quite often tourists and locals go to Mexico just to buy medicines, as they're available over the country and are much cheaper. Se debe reducir la dosis de apremilast a 30 mg una vez al da en pacientes con insuficiencia renal grave (Filtracin Glomerular estimada [FGe] menor de 30 ml/min/1,73 m2 o CLcr < 30 ml/min). Persistencia del efecto entre los sujetos aleatorizados a 30 mg de apremilast dos veces al da en la semana 0 y reasignados aleatoriamente a 30 mg de apremilast dos veces al da en la semana 32 hasta la semana 52, Pacientes que alcanzaron una respuesta PASI-75, Pacientes que alcanzaron una respuesta PASI-50, Cambio porcentual en el PASI con respecto al basal, media (%) DEa, Cambio en el DLQI con respecto al basal, media DEa, Proporcin de sujetos con psoriasis de la piel cabelluda y PGA de 0 o 1, n/N (%)b. a Incluye a los sujetos reasignados aleatoriamente a 30 mg de apremilast dos veces al da en la semana 32 con un valor basal y posbasal en la semana de evaluacin del estudio. Fertilidad y desarrollo embrionario temprano: En un estudio de fertilidad con ratones macho, la administracin oral de apremilast a dosis de 1, 10, 25 y 50 mg/kg/da no produjo efectos en la fertilidad de los machos; el nivel sin efecto adverso observado (NOAEL por sus siglas en ingls, No Observed Adverse Effect Level) para la fertilidad de los machos fue mayor de 50 mg/kg/da (3 veces la exposicin clnica). Hence why it was surrounded by a few security guards. La administracin concomitante de apremilast con dosis mltiples de rifampicina produjo una disminucin en el rea bajo la curva de concentracin plasmtica (AUC) de apremilast y de la concentracin srica mxima (Cmx) aproximadamente del 72% y del 43%, respectivamente. El diseo de los estudios era similar hasta la semana 32. Find one who has been doing this for a number of years if you can. Un total del 0,1% de los pacientes tratados con apremilast interrumpi el tratamiento debido a la reaccin adversa de prdida de peso. PDE4 inhibition results in . En un estudio combinado de toxicidad en el desarrollo embriofetal y de fertilidad en ratones hembra con dosis orales de 10, 20, 40 y 80 mg/kg/da se observaron una prolongacin de los ciclos estrales y un mayor tiempo hasta el apareamiento con las dosis de 20 mg/kg/da y superiores. No hay indicios de potencial inmunotxico, de irritacin drmica o fototxico. In the Netherlands, despite my health insurance and prescription I had to pay 55 Euros a month for these pills and required weekly visits at the hospital for a check-up. Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims. Antibiotics, like Amoxicillin and Ciprofloxacin Birth Control Erectile Dysfunction medications, like Viagra Blood Pressure medications, including Lisinopril and Atenolol With this expanded indication, Otezla is now the first and only oral treatment approved in adult patients . Where to Stay in Amsterdam: Best Neighborhoods By a Local. I ended up calling up multiple pharmacies in Mexico and found out that I can pick up Stelara from a pharmacy in Mexico City. The price of Otezla is around $3600 for a month's supply of medication (60 tablets); however, most people do not pay this price. De los pacientes con al menos una respuesta PASI-75 que fueron reasignados aleatoriamente a placebo en la semana 32 durante la fase de retirada del tratamiento aleatorizado, el 11,7% mantena una respuesta PASI-75 en la semana 52. It was the same exact drug in the same exact box I was receiving it in the Netherlands, but I had to pay 80 Pesos for a monthly supply, which is around 3.50 Euros. Within a month my psoriasis has cleared completely. Otezla can cause severe diarrhea, nausea, and vomiting, especially within the first few weeks of Show More. Its my mission to teach YOU how can you turn YOUR dreams of travel and career, into reality. Not surprisingly I was able to get Methotrexate, an oral medicine, over the counter for psoriasis that I was prescribed back in the Netherlands. Pacientes con peso ms bajo del normal: Se debe monitorizar peridicamente el peso de los pacientes que, al comienzo del tratamiento, tengan un peso inferior al normal. Los datos farmacocinticos son limitados en sujetos mayores de 75 aos en los ensayos clnicos. (I wrote more on psoriasis and pregnancy here). Otezla (apremilast) is a brand-name prescription drug that's used to treat certain autoimmune conditions. En estos pacientes, las respuestas ACR20/50/70 en la semana 52 fueron del 57%, 25% y 11%, respectivamente. Se desconoce si apremilast, o sus metabolitos, se excretan en la leche materna humana. Obviously would like to know a cost for a dosage which is every 60 days. As you can see medical tourism in Mexico has saved me twice. 2022 Amgen Inc. All rights reserved. Es preciso informar a pacientes y cuidadores de la necesidad de notificar al mdico prescriptor cualquier cambio de comportamiento o estado de nimo, as como cualquier episodio de ideacin suicida. When youre working remotely while traveling, this can sometimes lead to an unhealthy lifestyle. I require 90mg / 4 weeks, but get it every 8 weeks instead. En los estudios ESTEEM 1 y ESTEEM 2, se observaron mejoras significativas (reducciones) en la psoriasis ungueal, como determin el cambio porcentual medio en el ndice de gravedad de la psoriasis ungueal (NAPSI por sus siglas en ingls, Nail Psoriasis Severity Index) con respecto al basal en los pacientes tratados con apremilast, en comparacin con los tratados con placebo en la semana 16 (p < 0,0001 y p = 0,0052, respectivamente). Approved Uses Otezla (apremilast) is a prescription medicine used to treat adult patients with: Otezla is a pillnot a cream or injectionfor adults with plaque psoriasis. Es necesario un programa inicial de titulacin de dosis como se muestra en la Tabla 5. d sPGA = Evaluacin global esttica del mdico. Im approximately 2 hours from the Juarez, MX border Also curious if you have to see a dermatologist in Mexico for a scrip before purchasing the biological from a pharmacy and how Id go about finding a dermatologist that could write a script for it. My doctor and I decided to try Stelara, one dose every three months that I had to inject myself with. ** p 0,001 para apremilast frente a placebo. Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. My insurance company pays but my portion of the bill is eliminated. Apremilast se somete a un metabolismo extenso y slo el 3% y el 7% del compuesto original administrado se recuperan en orina y en heces, respectivamente. The PEHP Pharmacy Tourism Program allows you to fill 90-day supply of medications you are currently taking and save 40% - 60% during your deductible. El nivel sin efecto observado (NOEL por sus siglas en ingls, No Observed Effect Level) para la fertilidad de las hembras fue de 10 mg/kg/da (1,0 vez la exposicin clnica). Hence why no insurance company wants to pay for them. (Because home values have been increasing here in the states, this and a small nest egg would disqualify many applicants from this program in years past.) I need 4 doses per year. Now, Im a successful digital nomad who visited over 95 countries on 7 continents and lived in 8 countries. Pacientes con insuficiencia heptica: No se evalu la seguridad de apremilast en los pacientes con artritis psorisica o con psoriasis y con insuficiencia heptica. Fenner is not the only one thinking like this. No hubo interacciones medicamentosas farmacocinticas entre apremilast y los anticonceptivos orales que contienen etinilestradiol y norgestimato. No hubo efectos asociados a apremilast en la duracin de la gestacin, el nmero de ratones preados al final del periodo de gestacin, el nmero de ratones que parieron una camada, ni ningn efecto en el desarrollo de las cras pasado el da 7 de vida. After we canceled our US insurance we were denied residency in Italy and as a result, couldnt enter the Italian health system. zilch, nada, zero. En caso de sobredosis, se recomienda un cuidado sintomtico y de soporte. Did my psoriasis get cured? However, if you actually need specific treatment or surgery, it works. Los pacientes recibieron apremilast en combinacin con uno o ms de los siguientes: metotrexato (MTX, 25 mg/semana, 54,5%), sulfasalazina (SSZ, 2 g/da, 9,0%) y leflunomida (LEF; 20 mg/da, 7,4%). When I finally give up on signing up for national health insurance in Italy and Poland, as we werent able to do either, I thought Id just use my savings and pay for my medicine out of pocket until were able to get on the US health insurance again. No estaba permitido el tratamiento concomitante con FAMEs biolgicos, incluidos los bloqueadores de TNF. Thank you for all you knowledge about the prescription woes! It is a NEW program (for 20220 that you apply for in October in the preceding year). Call Farmacia Especializada and ask if they could deliver to you (https://www.farmaciasespecializadas.com/medicamentos/detalle/21997-stelara-45-mg-jgp-c1). Otezla is a medicine used to treat adults with: moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). Plus, you can get cash back up to $750 per trip. The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. La mejora en las puntuaciones en HAQ-DI se mantuvo en la semana 24. Las frecuencias de las reacciones adversas al medicamento son las notificadas en los grupos de apremilast de los cuatro estudios de fase III de artritis psorisica (n = 1945) o de los dos estudios de fase III de psoriasis (n = 1184) (en la tabla 4 se representa la frecuencia ms alta de los dos grupos de datos). Reporte las sospechas adversas a los correos: Distribuido y representante legal en Mxico: NRI (Por sus siglas en ingls, Non-responder imputation): Funcin fsica y calidad de vida relacionada con la salud: Health Assessment Questionnaire Disability Index, Tabla2. What, ironically, was faster than when I had to order it in California. No se use durante el embarazo, la lactancia ni en menores de 18 aos. 1. Which proved to be true. En los estudios PALACE 1, PALACE 2 y PALACE 3 las mejoras en la escala de actividad de la enfermedad (DAS28 por sus siglas en ingls, Disease Activity Score) utilizando la protena C reactiva (PCR) y en la proporcin de pacientes que alcanz los criterios de respuesta de la artritis psorisica (PsARC por sus siglas en ingls, Psoriatic Arthritis response criteria) modificados fueron mayores en el grupo de apremilast, en comparacin con placebo en la semana 16 (valor p nominal p < 0,0004, valor p 0,0017, respectivamente). As a digital nomad with no health insurance (no travel insurance covers chronic conditions) my options were limited to self-funded drugs. Methods of treating, managing or preventing psoriatic arthritis are disclosed. Active psoriatic arthritis. Las mujeres con capacidad de gestacin deben utilizar un mtodo anticonceptivo efectivo para prevenir el embarazo durante el tratamiento. Tell your Pacientes con peso ms bajo del normal: Se debe monitorizar peridicamente el peso de los pacientes que, al comienzo del tratamiento, tengan un peso inferior al normal. What documentation do you need to present the need for Stelara? La proporcin de pacientes que alcanz respuestas PASI-50, PASI-75 y PASI-90, y una puntuacin en la sPGA libre (0) o casi libre (1), se presenta en la Tabla 2. It also has a pretty historic system of getting the medicine out of the cellar, which works like the carousel you should see it for yourself. Por lo tanto, no se recomienda usar inductores enzimticos potentes del citocromo CYP3A4 (p. ej., nmero de articulaciones inflamadas, nmero de articulaciones dolorosas/doloridas, dactilitis y enteritis) y en las manifestaciones cutneas de psoriasis en los pacientes tratados con apremilast. Talk to one of the physician's assistants before your first meeting if you can. Last time they only had Stelara in branches in Mexico City. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF- or the inhibition of PDE4. Not surprisingly I was able to get Methotrexate, an oral medicine, over the counter for psoriasis that I was prescribed back in the Netherlands. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. El nmero de pacientes con los subtipos artritis mutilante y espondilitis predominante era demasiado pequeo para permitir una evaluacin significativa. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during Remember that stress is the biggest factor in aggravating psoriasis and moving so often is stressful. Estudios de carcinogenicidad: Los estudios de carcinogenicidad en ratones y ratas no mostraron indicios de carcinogenicidad asociada al tratamiento con apremilast. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Oral ulcers associated with Behets Disease. Descripcin de reacciones adversas seleccionadas: Notificacin de sospechas de reacciones adversas: Fertilidad y desarrollo embrionario temprano: INTERACCIONES MEDICAMENTOSAS Y DE OTRO GNERO: ALTERACIONES EN LOS RESULTADOS DE PRUEBAS DE LABORATORIO: Efectos sobre la capacidad para conducir vehculos y operar maquinaria: MANIFESTACIONES Y MANEJO DE LA SOBREDOSIFICACIN O INGESTA ACCIDENTAL: He ledo y acepto los Trminos y condiciones, RESTRICCIONES DE USO DURANTE EL EMBARAZO Y LA LACTANCIA, INTERACCIONES MEDICAMENTOSAS Y DE OTRO GNERO, MANIFESTACIONES Y MANEJO DE LA SOBREDOSIFICACIN O INGESTA ACCIDENTAL.

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