COMO FIGURA LA VERALIPRIDE Y COMO QUIERA QUE NO PODEMOS TRADUCIRLO TODO- SOLO HEMOS PODIDO TRADUCIR DEL HOLANDÉS AL ESPAÑOL ... EXPONEMOS EL POCO TRADUCIDO Y EL RESTO TAL CUAL- FIJARSE BIEN EN LA WEB. SENTIMOS LOS QUE SE MENCIONAN, NO EN LO REFERENTE A SANOFI AVENTIS Y MINISTERIO: BIEN SABEN CÓMO NOS HAN DEJADO A LAS MUJERES QUE TOMAMOS LA "VERALIPRIDE" -- ENVENADA NUESTRA SALUD DE POR VIDA" -- TAMBIEN SOMOS CONSCIENTES QUE LO QUE VAMOS A EXPONER " LO ENTENDERÁN LOS LABORATORIOS FARMACÉUTICOS Y QUÍMICOS, EL RESTO NI NOSOTRAS MISMAS, LO ENTENDEMOS PERO LO EXPONEMOS PARA QUE SE SEPAN TODAS LAS COSAS QUE DICEN SOBRE LOS MEDICAMENTOS: ¿ Y ESTO LO IBAN A CONOCER LOS MÉDICOS ESPAÑOLES? PUES NO Y MENOS AÚN SIN UNA "FICHA TÉCNICA" Y UN PROSPECTO DE VERGÜENZA. SI MINISTERIOS DE SANIDAD ESPAÑOL Y LABORATORIOS SANOFI AVENTIS

COMO FIGURA LA VERALIPRIDE Y COMO QUIERA QUE NO PODEMOS TRADUCIRLO TODO- SOLO HEMOS PODIDO TRADUCIR DEL HOLANDÉS AL ESPAÑOL ... EXPONEMOS EL POCO TRADUCIDO Y EL RESTO TAL CUAL- FIJARSE BIEN EN LA WEB. SENTIMOS LOS QUE SE MENCIONAN, PERO NO EN LO REFERENTE A SANOFI AVENTIS Y MINISTERIO: BIEN SABEN CÓMO NOS HAN DEJADO A LAS MUJERES QUE TOMAMOS LA "VERALIPRIDE" -- ENVENADA NUESTRA SALUD DE POR VIDA" -- TAMBIEN SOMOS CONSCIENTES QUE LO QUE VAMOS A EXPONER " LO ENTENDERÁN LOS LABORATORIOS FARMACÉUTICOS Y QUÍMICOS, EL RESTO NI NOSOTRAS MISMAS, LO ENTENDEMOS PERO LO EXPONEMOS PARA QUE SE SEPAN TODAS LAS COSAS QUE DICEN SOBRE LOS MEDICAMENTOS: ¿ Y ESTO LO IBAN A CONOCER LOS MÉDICOS ESPAÑOLES? PUES NO Y MENOS AÚN SIN UNA "FICHA TÉCNICA" Y UN PROSPECTO DE VERGÜENZA. "SI MINISTERIOS DE SANIDAD ESPAÑOL Y LABORATORIOS SANOFI AVENTIS".

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secado, corte, excremento, metástasis, uitzondering_geval, complicaciones ulcerosas, ultra_geluid, ultrasonidos, urato, uracil arabinósido, uretral, urea, trastornos del ciclo de la urea, la incontinencia de urgencia, los agentes uricosúricos, difosfato de uridina glucuronosiltransferasa, vaat_verwijdering, vaat_verwijding, vasodilatadores, vaccin_gerelateerd, vaccin_productie, vaccinatie_advies, vaccinatie_campagne, vacuolización, Trap-ascensores, Valbondione, valdecoxib, valproato, valproà ácido ¯, valsartan, vanauc, vardenafil, varicela, varices, vasculogénesis, la vasodilatación, la vasopresina, combinación fija de productos, ayuno, veehouderij_omstandigheid, VEGF, vegf_a, vegf_remmer, veiligheid_functie, veiligheid_gebeurtenis, veiligheid_overweging, veiligheid_reden, farmacología de seguridad, campo veld_omstandigheid excreción del virus, venlafaxina, punción venosa, la venlafaxina, la venlafaxina, venlafaxina, titular de la válvula, veraliprida, anclaje, dilución, verdunning_instructie, verdunning_vloeistof, estudios de compatibilidad , reunidos vergelijking_basis, endurecido, ansiedad de separación, vermoeidheid_verschijnsel, sesión de nebulización, la destrucción, las células Vero, la regulación, verordering, obsoleta, dispersa, vertaal_werkzaamheid, vertebral, la verteporfina, falsificación confidencial, vervanging_therapie, el transporte, la expectativa, la remisión, informado, verzorging_middel, enfermería, vesico -lobulli, vet_alcohol, vet_her_verdeling, vi, vi-polisacárido vacuna, vildagliptina, alcaloides de la vinca dendosering, PegIntron, viramune_therapie, virback, virus_infectie, virussen_infectie, vitamine_supplement, vitaminas deficià varianza ", vitro, la unión in vitro, vitro_gegeven, vitro_onderzoek , vivo, vivo de micronúcleos estudio in vivo....

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;I have 51 categories used. Problem(1,0,208) #value: 6 #valueChange: 1290200 #doChange: 933274

 http://opus.lingfil.uu.se/wordalign/EMEA/mosesalign/nl-en/corpus/en.vcb.classes.cats

------------

¿ por que no nos dieron: excrementos?

igual no sufriríamos, lo que estamos sufriendo.

ACLIMAFEL (VERALIPRIDA) EN MÉXICO: FEDERACIÓN Y ASOCIACIÓN MEXICANAS DE ESTUDIOS SOBRE EL CLIMATERIO AÑO 2012 -- TODAS LAS MUJERES ESPAÑOLAS, FRANCESAS, ITALIANAS, PORTUGUESAS ... QUE TOMAMOS LA VERALIPRIDE/VERALIPRIDA, AÚN NOS ENCONTRAMOS A LA ESPERA .......

ACLIMAFEL (VERALIPRIDA)  EN MÉXICO:

FEDERACIÓN Y ASOCIACIÓN MEXICANAS DE ESTUDIOS SOBRE EL CLIMATERIO, AÑO 2012 -- TODAS LAS MUJERES ESPAÑOLAS, FRANCESAS, ITALIANAS, PORTUGUESAS ... QUE TOMAMOS LA VERALIPRIDE/VERALIPRIDA, AÚN NOS ENCONTRAMOS A LA ESPERA DE QUE SE NOS INDIQUE:

¿ CUÁL FUÉ EL DOCUMENTO DE LA ORGANIZACIÓN MUNDIAL DE LA SALUD, QUE SEGÚN USTEDES " SE HABÍA RECTIFICADO?.

Como no son capaces de hacer público ese documento de la OMS., sobre la Veralipride/Veraliprida " POR QUE NO EXISTE".

Y bien que lo sabemos la mujeres que tomamos ese medicamento " Doctores/Doctoras" de los Estudios sobre el Climaterio en México.

Aquí nos encontramos Dres./Dras., con muchisimas Secuelas Severas e Irreversibles.

Ustedes sí que habrán o están gozando de sus vacaciones, pero nosotras " NO TENEMOS VACACIONES".

Francamente que les deseamos que las DISFRUTEN pero " NO MIENTAN A LAS MUJERES DE MÉXICO". con el ACLIMAFEL/VERALIPRIDA.

SIGUE VIGENTE:



Veraliprida

(Agreal ® - Sanofi Synthelabo )

Más riesgos que beneficios: la retirada del mercado de todas las presentaciones.

Fuente: OMS. Alerta número 116: veraliprida. Palabra de la Salud. Jul-2007.

La Agencia Europea de Medicamentos (EMEA) ha publicado una nota recomendando la retirada de la autorización de comercialización de todos los productos farmacéuticos que contienen veraliprida. La Agencia hizo esta recomendación bajo la orientación del Comité de Medicamentos de Uso Humano

Use (CHMP) de los riesgos del tratamiento de los sofocos asociados a la menopausia, con veraliprida, son mayores que sus beneficios.

El CHMP evaluó toda la información sobre la seguridad y eficacia de la veraliprida y llegó a la conclusión de que no sólo muestran una eficacia limitada, veraliprida se asocia con efectos adversos como la discinesia depresión, la ansiedad y la tardía (alteración del movimiento voluntario que pueden ser de larga duración o irreversible) durante y después del tratamiento.

La Comisión llevó a cabo este análisis después de la demanda de la Comisión Europea en septiembre de 2006, cuando veraliprida fue retirado del mercado español debido a los informes de graves desórdenes del sistema nervioso central.

La EMEA ha anunciado que los pacientes que están tomando veraliprida como tratamiento de los sofocos deben consultar a su médico para discutir otras opciones de tratamiento, si es necesario, el tratamiento veraliprida no debe interrumpirse bruscamente, las dosis deben reducirse gradualmente.

referencia:

Comunicado de Prensa, Agencia Europea de Medicamentos Oficina de Prensa

19 de julio 2007 (www.emea.europa.eu  /  )

Agencia Europea del Medicamento da recomendaciones a hacer frente a las preocupaciones de garantía de esterilidad para DepoCyte

EMA/CHMP/555991/2012
24 August 2012
Press Office

Traductor Internet:

Agencia Europea del Medicamento da recomendaciones a hacer frente a las preocupaciones de garantía de esterilidad para DepoCyte.

Inspección detecta fallos de fabricación

La Agencia Europea de Medicamentos ha acordado hoy una serie de medidas preventivas para hacer frente a las deficiencias de fabricación que podrían afectar a la esterilidad de DepoCyte (citarabina), un medicamento contra el cáncer utiliza para tratar la meningitis linfomatosa. Estas medidas están destinadas a proteger a los pacientes de los efectos potencialmente nocivos, mientras que también permite acceso continuo al tratamiento de pacientes que no tienen alternativas adecuadas.

En la actualidad, no hay evidencia de cualquier contaminación microbiana del producto en el mercado o riesgo para los pacientes. Sin embargo, el Comité de la Agencia de Medicamentos de Uso Humano (CHMP)  ha recomendado, como medida de precaución, que DepoCyte se recordará de todos los países de la Unión Europea donde adecuados tratamientos alternativos están disponibles. Para los pacientes que ya están en marcha DepoCyte y para los que los tratamientos alternativos no son apropiados, puede ser posible para los médicos para solicitar un suministro de DepoCyte para continuar el tratamiento. En países de la UE sin alternativas terapéuticas adecuadas, DepoCyte se mantendrá en el mercado, pero con recomendaciones específicas para controlar la seguridad de los pacientes, en particular a los signos y síntomas de infección.

Un documento de preguntas y respuestas con recomendaciones detalladas para profesionales de la salud está disponible en la página web de la Agencia. Profesionales de la salud va a recibir una carta que explique las medidas que se aplican en su país.

DepoCyte es una suspensión de liberación prolongada para la citarabina liposomal inyectable que contiene para el tratamiento por vía intratecal de la meningitis linfomatosa. Esto significa que se administra mediante inyección directamente en el líquido cefalorraquídeo.

Una inspección reciente realizada conjuntamente por Francia y el Reino Unido en la instalación de fabricación de DepoCyte en San Diego en los Estados Unidos, Pacira Pharmaceuticals Inc, identificó una serie de

deficiencias de fabricación. Los resultados se refieren a la falta de garantía de esterilidad adecuada en el proceso de fabricación. Tras la evaluación de los datos disponibles, el CHMP concluyó que estos hallazgos representan un riesgo teórico de fallo esterilidad, aunque actualmente no hay datos que indiquen que se ha producido un impacto negativo en el producto acabado.

La producción y liberación de lotes de DepoCyte se encuentran actualmente en espera. Nuevos lotes de DepoCyte sólo se fabricará una vez que todas las deficiencias han sido resueltos y una nueva inspección ha indicado el lugar de fabricación para cumplir con las buenas prácticas de fabricación (GMP) requisitos.

_________________________________________



Notas

1. Este comunicado de prensa, junto con todos los documentos relacionados, se encuentra disponible en la página web de la Agencia.

2. La inspección fue realizada por el Reino Unido y Francia los organismos de reglamentación farmacéutica en julio de 2012.

3. DepoCyte se ha autorizado en la Unión Europea desde el 11 de julio de 2001 y se comercializa en Austria, Bélgica, Bulgaria, República Checa, Dinamarca, Finlandia, Francia, Alemania, Irlanda, Italia, Países Bajos, Polonia, Rumania, Eslovaquia, Eslovenia, España , Suecia y el Reino Unido, así como en Islandia y Noruega.

4. Meningitis linfomatosa es una condición en la que las células de un linfoma (un tumor en el sistema linfático) se han extendido al fluido espinal y las meninges (las membranas que rodean al cerebro y la médula espinal).

5. Alternativas terapéuticas incluyen medicamentos que contienen citarabina liposomal no, metotrexato o tiotepa. Cabe señalar que no todos los productos alternativos están aprobados para uso intratecal. Para más información sobre las indicaciones y posología de los tratamientos alternativos, la información del producto debe ser consultado.

6. Más información sobre la labor de la Agencia Europea de Medicamentos puede encontrar en su sitio web:

www.ema.europa.eu

Póngase en contacto con nuestros agentes de prensa

Monika Benstetter o Martin Harvey Allchurch

Tel. +44 (0) 20 7418 8427

E-mail: press@ema.europa.eu    

CONOCIAN QUE EN EE.UU. .......Novartis Pharmaceuticals Corporation

Tema:


• Actualización de la FDA para Label Tekturna ® (aliskiren), Tekturna HCT ® (aliskiren e hidroclorotiazida),

Tekamlo ™ (aliskiren y amlodipino) y Amturnide ™ (aliskiren, amlodipino y

hidroclorotiazida) tabletas

• Valturna ® (aliskiren y valsartán, USP) Cese voluntaria al mercado en EE.UU.

Novartis Pharmaceuticals Corporation


East Hanover, NJ 07936


04 2012

Estimado Profesional de la Salud:

En enero de 2012, Novartis Pharmaceuticals Corporation (Novartis) le informó acerca de la información importante de seguridad nuevo para aliskiren (aliskiren), tras los resultados provisionales de la prueba Aliskiren en la diabetes tipo 2 Uso de Cardio-Renal Endpoints (altitud).

Después de los EE.UU. Food and Drug Administration (FDA) la revisión de los datos de los estudios preliminares ALTITUD e interacciones extensas con Novartis, la FDA llegó a la conclusión de que la etiqueta de Tekturna y otros productos a base de aliskiren debe ser actualizada.

A petición de la FDA, Novartis ha actualizado la información de prescripción completa para Tekturna ® (aliskiren), Tekturna HCT ® (aliskiren e hidroclorotiazida), Tekamlo ™ (aliskiren y amlodipino) y Amturnide ™ (aliskiren, amlodipino e hidroclorotiazida) tabletas para incluyen:

oa contraindicación contra el uso combinado de productos a base de aliskiren con ARA II o inhibidores de la ECA en pacientes con diabetes.

oa advertencia contra el uso de productos a base de aliskiren en pacientes con insuficiencia renal moderada (del riñón) grave (TFG <60 ara="ara" de="de" eca="eca" est="est" ii.="ii." inhibidor="inhibidor" la="la" min="min" ml="ml" n="n" o="o" que="que" tambi="tambi" tomando="tomando" un="un">

El juicio ALTITUD fue el primer estudio a largo plazo para investigar Tekturna ® (aliskiren) en un entorno de más de un año en pacientes con diabetes tipo 2 e insuficiencia renal. Estos pacientes también estaban tomando un inhibidor de la ECA o un BRA y se sabe que están en alto riesgo de eventos cardiovasculares y renales.

En diciembre de 2011, después de una mediana de seguimiento de aproximadamente 27 meses, el ensayo se terminó antes de tiempo por falta de eficacia. Mayor riesgo de insuficiencia renal, hipotensión, hiperpotasemia y se observó en aliskiren en comparación con pacientes tratados con placebo. El riesgo de accidente cerebrovascular (2,7% vs placebo aliskiren 2,0%) y la muerte

IMPORTANTE

DROGAS

ADVERTENCIA

(6,9% frente a placebo aliskiren 6,4%) también fueron numéricamente mayor en los pacientes tratados con aliskiren. Ver información de prescripción completa adjunta para información adicional sobre el proceso ALTITUD.

Tekturna, Tekturna HCT, Tekamlo y Amturnide seguirá estando disponible para el tratamiento de la hipertensión arterial en los pacientes apropiados.

Además, y en consulta con la FDA, Novartis ha decidido dejar voluntariamente para comercializar Valturna ® en los EE.UU.. Valturna es una combinación única pastilla que contiene aliskiren y valsartán la que sólo está disponible en los EE.UU..

En vista de la importancia de controlar la presión arterial alta y para asegurar una transición ordenada de los pacientes a controlar la presión arterial alternativa terapias, Novartis se asegurará de que Valturna está disponible hasta 20 de julio 2012 para permitir a los médicos a los pacientes de transición a otro tratamiento de la hipertensión.

Los pacientes que toman Valturna no debe parar su tratamiento de la hipertensión sin consultar a su proveedor de prescripción médica. Novartis aconseja a los pacientes a buscar la guía de su proveedor de atención médica que prescribe en su siguiente (no urgente) visita, antes del 20 de julio de 2012, para determinar el tratamiento alternativo apropiado.

Los profesionales sanitarios que requieran información adicional puede ponerse en contacto Novartis sin cargo al 1-888-997-5385 o visite www.pharma.us.novartis.com.

Novartis cree que Tekturna, Tekturna HCT, Tekamlo y Amturnide seguirán siendo importantes opciones de tratamiento para el manejo de la presión arterial alta.

La seguridad del paciente es la mayor prioridad para Novartis, y la compañía continuará trabajando con las autoridades sanitarias de todo el mundo en el mejor interés de los pacientes.

Convocatoria de presentación de informes profesionales sanitarios deben informar de cualquier sospecha de reacción adversa asociada con el uso de aliskiren (ver más abajo).

Las sospechas de reacciones adversas a los medicamentos debe ser comunicado a los EE.UU. Food and Drug Administration en 1-800-FDA-1088 o mediante el uso de MedWatch (www.fda.gov / Seguridad / MedWatch).

Sospechas de reacciones adversas asociadas con el uso de aliskiren también debe ser comunicado a Novartis en 1-888-NOW-NOVA (1-888-669-6682).

Consulte la información de prescripción completa, incluida la advertencia en el envase, para Tekturna,

Tekturna HCT, Tekamlo y Amturnide.

Atentamente,

Usman Azam, M. D.

Cabeza, EE.UU. Médico y Asuntos de la Reglamentación Farmacéutica

América del Norte

Novartis Pharmaceuticals Corporation

-------------


Novartis Pharmaceuticals Corporation


East Hanover, NJ 07936



April 2012



Dear Healthcare Professional:

In January 2012, Novartis Pharmaceuticals Corporation (Novartis) informed you about important new safety information for aliskiren (Tekturna) following interim results from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).

Following the US Food and Drug Administration’s (FDA) review of the preliminary ALTITUDE study data and extensive interactions with Novartis, the FDA concluded that the label for Tekturna and other aliskiren-based products should be updated.

At the request of the FDA, Novartis has updated the full Prescribing Information for Tekturna® (aliskiren), Tekturna HCT® (aliskiren and hydrochlorothiazide), Tekamlo™ (aliskiren and amlodipine), and Amturnide™ (aliskiren, amlodipine and hydrochlorothiazide) tablets to include:

o a contraindication against combined use of aliskiren-based products with ARBs or ACE inhibitors in patients with diabetes.

o a warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR <60 ace="ace" also="also" an="an" arb="arb" are="are" inhibitor.="inhibitor." min="min" ml="ml" or="or" taking="taking" who="who">

The ALTITUDE trial was the first long-term study to investigate Tekturna® (aliskiren) in a setting of more than one year in patients with type 2 diabetes and renal impairment. These patients were also taking either an ACE inhibitor or an ARB and were known to be at high risk for cardiovascular and renal events.

In December 2011, after a median follow-up of about 27 months, the trial was terminated early for lack of efficacy. Higher risk of renal impairment, hypotension and hyperkalemia was observed in aliskiren compared to placebo treated patients. The risk of stroke (2.7% aliskiren vs 2.0% placebo) and death

IMPORTANT

DRUG

WARNING

(6.9% aliskiren vs 6.4% placebo) were also numerically higher in aliskiren treated patients. See enclosed full Prescribing Information for additional information on the ALTITUDE trial.

Tekturna, Tekturna HCT, Tekamlo, and Amturnide will continue to be available for the treatment of high blood pressure in appropriate patients.

In addition, and in consultation with the FDA, Novartis has decided to voluntarily cease to market Valturna® in the US. Valturna is a single pill combination that contains aliskiren and the ARB valsartan that is only available in the US.

In view of the importance of controlling high blood pressure and to ensure an orderly transition of patients to alternate blood pressure controlling therapies, Novartis will ensure that Valturna is available until July 20, 2012 to enable physicians to transition patients to another hypertension treatment.

Patients taking Valturna should not stop their hypertension treatment without consulting their prescribing healthcare provider. Novartis advises patients to seek guidance from their prescribing healthcare provider at their next (non-urgent) visit, prior to July 20, 2012, to determine appropriate alternate therapy.

Healthcare professionals who require additional information can contact Novartis toll free at 1-888-997-5385 or visit www.pharma.us.novartis.com.

Novartis believes that Tekturna, Tekturna HCT, Tekamlo, and Amturnide will continue to be important treatment options for the management of high blood pressure.

Patient safety is the highest priority for Novartis, and the company will continue to work with health authorities worldwide in the best interest of patients.

Call for Reporting Healthcare professionals should report any suspected adverse reactions associated with use of aliskiren (see below).

Suspected adverse drug reactions should be reported to the US Food & Drug Administration at 1-800-FDA-1088 or by use of MedWatch (www.fda.gov/Safety/Medwatch).

Suspected adverse reactions associated with the use of aliskiren should also be reported to Novartis at 1-888-NOW-NOVA (1-888-669-6682).

Please see accompanying full Prescribing Information, including Boxed WARNING, for Tekturna,

Tekturna HCT, Tekamlo, and Amturnide.

Sincerely,



Usman Azam, M.D.

Head, US Medical & Drug Regulatory Affairs

North America

Novartis Pharmaceuticals Corporation  

 

EL TRIBUNAL SUPREMO DE LA INDIA APLAZA EL JUICIO DE NOVARTIS SOBRE PATENTE

EL TRIBUNAL SUPREMO DE LA INDIA APLAZA EL JUICIO DE NOVARTIS SOBRE PATENTE

22-08-2012 / 13:30 h EFE

 

El Tribunal Supremo de la India aplazó hoy hasta septiembre el inicio del juicio que enfrenta a la farmacéutica multinacional Novartis con los fabricantes de genéricos del gigante asiático, informó a Efe una fuente de la compañía.

"No ha habido vista hoy. Se ha aplazado hasta el próximo 11 de septiembre", explicó a Efe la portavoz de Novartis en la India Svetlana Pinto.

El juicio, que tenía previsto su inicio hoy, debe resolver si se concede una patente en la India al medicamento anticancerígeno Glivec de la multinacional, actualmente reemplazado en el mercado por versiones indias mucho más baratas.

Los analistas creen que una sentencia favorable a Novartis podría tener un efecto dominó en otras disputas similares y poner en peligro que la India continúe siendo el principal suministrador de genéricos del mundo, especialmente a países en vías de desarrollo.

La India dejó en 1970 de conceder patentes de medicamentos, pero la ley fue enmendada en 2005 en cumplimiento con la normativa de la Organización Mundial del Comercio (OMC), de la que el gigante asiático es estado miembro.

Nueva Delhi se abrió entonces a admitir el registro de medicamentos pero estableció el merecimiento de la patente en función de que el  fármaco presentase una innovación significativa.

En el caso de Novartis, que lleva seis años inmerso en una batalla legal en la India, diferentes tribunales del país asiático han considerado que su fármaco anticancerígeno no representa una innovación, y por ello la multinacional recurre al Supremo.

En 2006, cuando la India rechazó la patente de la multinacional por el mesilato de imatinib (comercializado como Glivec o Gleevec), el fármaco de Novartis costaba 2.600 dólares por paciente al mes, y las versiones genéricas indias solo 200 dólares.

Según Médicos Sin Fronteras (MSF), "si Novartis gana el caso, se concederían otras patentes como sucede en los países poderosos" y "la India no sería capaz de continuar suministrando a gran parte del mundo subdesarrollado medicamentos asequibles de calidad".

El 80 % de las medicinas que utiliza Médicos Sin Fronteras (MSF) para tratar a 170.000 personas con el virus del sida en el mundo son genéricos indios.

La codeína y sus reacciones adversas en niños. Administración estadounidense del Medicamento (FDA)

La codeína y sus reacciones adversas en niños.

La Administración estadounidense del Medicamento (FDA) está revisando los reportes sobre ciertos niños que desarrollaron reacciones adversas graves o murieron, tras tomar codeína para aliviar el dolor después de una amigdalectomía y/o adenoidectomía por el síndrome de apnea obstructiva del sueño.


La codeína es un analgésico opiáceo utilizado para tratar dolor leve a moderadamente severo y para reducir la tos, generalmente en combinación con otros medicamentos.

Cuando se ingiere codeína, una enzima llamada citocromo P450 2D6 (CYP2D6) la convierte en morfina en el hígado. Algunas personas tienen variaciones de ADN que hacen esta enzima más activa, lo que causa que la codeína se convierta en morfina más rápido y más eficientemente que en otras personas.

Un alto nivel de morfina puede causar dificultades para respirar, lo que puede ser mortal, por lo que tomar codeína después de una amigdalectomía y/o adenoidectomía puede aumentar el riesgo de problemas respiratorios y muerte en los niños que son “metabolizadores ultrarrápidos”.

La FDA tiene un estudio de seguridad en curso para determinar si hay casos de sobredosis accidental o muerte en niños que estaban tomando codeína, y si se producen reacciones adversas durante el tratamiento de otros tipos de dolor.

Los profesionales sanitarios tienen que tener claro que si se les recetan a niños medicamentos que contienen codeína, debe utilizar la dosis eficaz más baja durante el período de tiempo más breve posible.

Los padres y cuidadores que observen somnolencia, confusión o dificultad en la respiración o ruidos inusuales cuando el niño respira, deben dejar de darle codeína al niño y buscar atención médica de inmediato ya que estos son indicios de sobredosis.

http://farmacovigilancia.tv/blog/la-codeina-y-sus-reacciones-adversas-en-ninos/

-----------

EN ADULTOS: LA CODEINA.

Esta Asociación Agreal Luchadoras, está en disposición de un caso y no de una enferma por el Agreal/Veraliprida:

Mujer que por la toma para los sofocos en el Climaterio, llevaba dos años tomando: Tratamiento Hormonal Sustitutivo (2004-2005 prescripción médica, sin antecedentes familiares), el cual le produce cáncer de mamas, debe de ser operada urgentemente: extirpación de los ganglios centinelas y parte de un pecho. Una vez operada y dentro del quirófano, se le administra Codeina.

Se queda sin pulso, casi sin tensión. Muchos, muchisimos intentos para que no se les fuera. Gritos ¡¡ se nos vá !! ¡¡ se nos vá !!, luego de muchas reanimaciones comenzó a reaccionar. ¡¡ qué susto !! se nos iba esta mujer.

Desde las 8 horas de la mañana hasta las 19,30 tarde, la tuvieron en recuperación, hasta que estuvo totalmente estabilizada.

ERA Y ES : ALERGICA A LA CODEINA.

POLÉMICA EN ALEMANIA POR EL NUEVO TEST DE DETECCIÓN PRENATAL DEL SÍDROME DE DOWN

POLÉMICA EN ALEMANIA POR EL NUEVO TEST DE DETECCIÓN PRENATAL DEL SÍDROME DE DOWN.

El ejecutivo alemán señaló que la prueba es «ilegal» porque se trata de una «selección de los seres humanos por trisomía».

Desde esta semana se encuentra disponible en el mercado, un test de detección prenatal del síndrome de Down. Se trata del «PraenaTest», fabricado por la farmacéutica alemana LifeCodexx. La prueba se encontraría ya distribuida en más de 70 clínicas y consultas médicas de Alemania, Austria, Lichtenstein y Suiza. La compañía ha descrito el «PraenaTest» como una «alternativa segura a los procedimientos invasivos comunes como la amniocentesis», ya que se trata de una prueba de sangre, que en el caso de resultar positivo debe ser corroborado por la prueba tradicional.

El test está disponible para todas las embarazadas que se encuentren a partir de la semana 12 de embarazo y que tengan un elevado riesgo de que sus fetos tengan una «trisomía 21», el trastorno genético causado por la presencia de una copia extra del cromosoma 21 –uno de los 23 pares de cromosomas del cariotipo humano– que genera deficiencias cognitivas y corporales en los fetos, conocidos como síndrome de Down.

Selección de fetos

Que su comercialización luego de varios años de investigación se haya finalmente realizado, no ha sido fácil: la Federación Internacional de síndrome de Down intentó evitar que el test saliera al mercado ante el Tribunal Europeo de Derechos Humanos. La Federación, que reúne a 30 asociaciones en 16 países, ha llamado a «reconocer la condición humana y proteger el derecho a la vida de las personas con síndrome de Down o con cualquier otra discapacidad».

La misma Federación ha alertado sobre el «peligro de eugenesia», esto es: intervenir en la mejora de la especie humana, ya que se prevé un aumento sustancial del número de abortos en los embarazos en los que el test de resultado positivo. Esto último lo confirma el hecho de que el 80% de las embarazadas que se han hecho una prueba con resultado positivo, han terminado decidiendo abortar. La selección de fetos es también la razón que distintas iglesias y asociaciones sean críticas a la prueba.

Sin embargo, el «Land» de Baden-Württemberg, sede del fabricante y por ello competente en la materia, decidió no prohibir la prueba por no ir en contra de las premisas legales de la ley de diagnóstico genético. LifeCodexx desarrolló su prueba sanguínea con datos recabados entre 2009 y 2012 en cooperación con centros y clínicas prenatales en Alemania y en Suiza.

El Ejecutivo alemán –coalición democristiano-liberal–, a través Hubert Hüppe, portavoz del área responsable de las personas con discapacidad en Alemania, exigió la prohibición de la prueba argumentando una incompatibilidad con el marco legal actual. Según Hüppe, la prueba es simplemente «ilegal» argumentando que se trata de una «selección de los seres humanos por trisomía».

Según LifeCodexx, el nuevo test tiene paradójicamente por objeto reducir el número de los abortos y «salvar la vida de hasta 700 niños sólo en Alemania, que mueren al año derivados de complicaciones por análisis invasivos». Esto, ya que test posibilita el reconocimiento del síndrome de Down sin amniocentesis, lo que implicaba una punción en la bolsa amniótica que podía ocasionar problemas médicos e incluso un aborto.

El presidente de la empresa, Michael Lutz, ha adelantado que están preparando más pruebas para detectar otras modificaciones en los cromosomas como trisomía 13 y 18.

Lutz es doctor en química con experiencia en empresas de biotecnología como Cogenics y Epidaurosand Sunyx, y ha trabajado en diversos cargos ejecutivos en Novartis Pharma y Evotec. Por su parte, LifeCodexx –filial de GATC Biotech SA– es el primer proveedor europeo de secuenciación del ADN. La empresa está especializada en el desarrollo de pruebas de diagnóstico moleculares basada en la implementación de nuevas tecnologías de secuenciación.

http://www.abc.es/20120822/sociedad/abci-test-prenatal-sindrome-down-201208211938.html

GlaxoSmithKline Reino Unido -- Zovirax Suspensión 200mg/5ml (Aciclovir)

Estimado Profesional de la Salud,


GlaxoSmithKline Reino Unido

Zovirax Suspensión 200mg/5ml

(Aciclovir)

PL 00003/0202

GlaxoSmithKline del Reino Unido están retirando múltiples lotes de botellas de 125 ml del producto anterior. Esto se debe a las instrucciones de dosificación incorrectos en la sección 3 del prospecto que asesoran a los pacientes a tomar la mitad de la dosis recomendada. Un listado lote completo se proporciona en la página 2. Por favor, envíe ambas páginas de este documento a los destinatarios mencionados.

Para consultas de información médica, por favor póngase en contacto con GlaxoSmithKline Reino Unido Información Médica

Departamento al 0800 221 441.

Para consultas relativas a la rentabilidad de las acciones, por favor póngase en contacto con su mayorista o llame GlaxoSmithKline Reino Unido

Equipo de Atención al Cliente al 0800 221 441.

Los beneficiarios de esta Alerta de Drogas debería señalar a la atención de los contactos pertinentes con copia de esta carta.

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Atentamente

Ian Holloway

MHRA DMRC Gerente  

Desaconsejan los fármacos con calcitonina por riesgo de tumores

La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha desaconsejado el uso de medicamentos que contienen calcitonina -una hormona que inhibe la resorción ósea- para tratamientos prolongados ya que se ha constatado que tras recibirlos se "incrementa ligeramente el riesgo de tumores".

Así lo ha hecho publico la AEMPS, después de que el comité científico de la Agencia Europea de Medicamentos realizará una revisión del balance beneficio-riesgo de los medicamentos que contienen calcitonina.

Según la Agencia Española del Medicamento, el análisis de todos los datos disponibles ha mostrado que, aunque el número de casos de tumores identificados fue bajo, existe un "ligero incremento del riesgo de tumores" en pacientes que recibieron durante un tiempo prolongado calcitonina, sin que se haya asociado a un determinado tipo de tumor.

La agencia ha recomendado que los fármacos que emplean esta hormona solo se utilicen en tratamientos de corta duración y, en concreto, ha desaconsejado su utilización para el tratamiento de la osteoporosis, ya que existen otras alternativas terapéuticas.

Medida de precaución

Por ello, hasta que se adopte la decisión final por parte de la Comisión Europea, la AEMPS subraya, como medida de precaución, que no se inicien nuevos tratamientos para la indicación de osteoporosis con calcitonina intranasal y que se revisen los tratamientos en curso en pacientes que sufran esta patología, valorando posibles alternativas terapéuticas.

La calcitonina se encuentra comercializada en España (en forma de calcitonina de salmón o calcitonina de anguila -elcatonina-) en medicamentos para uso por vía parenteral y en fármacos para administración mediante pulverización intranasal. Los preparados parenterales están indicados en la prevención de la pérdida aguda de masa ósea debida a una inmovilización repentina, en enfermedad de Paget y en hipercalcemia maligna. Mientras tanto, los preparados para la administración intranasal están indicados en el tratamiento de la osteoporosis postmenopáusica para reducir el riesgo de fracturas vertebrales.

Recomendaciones

El Comité Científico de la Agencia Europea del Medicamento ha concluido que los beneficios del uso de calcitonina para reducir el riesgo de fracturas vertebrales en la osteoporosis postmenopáusica no superan los riesgos y por ello ha recomendado que la solución para pulverización intranasal, únicamente indicada para el tratamiento de la osteoporosis, sea retirada del mercado.

Para el resto de las indicaciones autorizadas, enfermedad de Paget, prevención de pérdida aguda de masa ósea debida a inmovilización repentina e hipercalcemia causada por cáncer, el balance beneficio-riesgo de calcitonina por vía parenteral permanece favorable, pero se recomienda que el tratamiento se limite al menor tiempo posible.

Para el tratamiento de pacientes con enfermedad de Paget, se recomienda limitar su uso. El tratamiento no debe superar los tres meses, a menos que se den circunstancias excepcionales, en las que puede ser ampliado a seis meses. No obstante, la repetición intermitentemente del tratamiento puede valorarse si los beneficios potenciales superan los riesgos.

Para la prevención de pérdida aguda de masa ósea debida a una inmovilización repentina, como en el caso de pacientes con fracturas osteoporóticas recientes, el tratamiento con calcitonina parenteral deberá tener una duración limitada de entre dos y cuatro semanas.

La AEMPS ha asegurado que informará sobre el momento en que sea efectiva la suspensión de la autorización de comercialización de los medicamentos que contienen calcitonina intranasal.

http://www.que.es/ultimas-noticias/sociedad/201208222058-desaconsejan-farmacos-calcitonina-riesgo-tumores-rc.html?anker_2

QUE SE SEPA: "GOBIERNOS DE TODO EL MUNDO" PARA EL ACCESO A LOS MEDICAMENTOS " NO DEBEN DE EXISTIR: NI SERES HUMANOS RICOS, NI SERES HUMANOS POBRES" - TODOS SON Y SOMOS ESO " SERES HUMANOS".

Traductor Internet:

Estimado Sr. Durisch,

Gracias por su carta en nombre de los miembros de Sorne de la comunidad de ONG con respecto a los constantes esfuerzos de Novartis para asegurar una patente para Glivec ® en la India. Le agradezco esta oportunidad de compartir la perspectiva Novartis con usted.

India se caracteriza por la diversidad económica significativa. IR tiene una clase media en auge, por un lado, y un gran número de personas extremadamente pobres, por el otro. Como resultado, nos están llevando a cabo una doble estrategia centrada en el paciente en la India. Nos dirigimos a los muchos obstáculos que enfrentan los pacientes desfavorecidos en cuanto al acceso ta de atención médica y tomar en serio la India como potencia mundial formidable con todos los derechos y obligaciones internacionales que dicha condición conlleva. Buscamos establecer una protección eficaz de la innovación farmacéutica en la India.

En Novartis, creemos firmemente que las patentes y los sistemas efectivos de patentes salvar vidas estimulando la investigación que lleva a los medicamentos innovadores y terapias innovadores como Glivec ®. Glivec ® ha sido patentado en países de todo el mundo, tanto en el mundo desarrollado y en desarrollo. En la India estamos buscando orientación sobre la correcta interpretación de la Ley de Patentes de la India.

El conflicto en la India sobre Glivec ® está sobre la patentabilidad de la innovación farmacéutica en la India y no sobre el acceso a la medicina. No estamos desafiando cualquiera de las flexibilidades comerciales que existen en el marco del acuerdo sobre los ADPIC y la Declaración de Doha, en lugar de resolver cualquier conflicto entre los derechos de propiedad intelectual y el acceso a la medicina. Como consecuencia, los pacientes el acceso a los países en desarrollo no se verán afectados por esta acción legal.

Al igual que los grupos a los que representan, también estamos profundamente preocupados por asegurar que

pacientes tengan acceso a los tratamientos que necesitan. Nos esforzamos por ser un socio en la búsqueda y aplicación de soluciones que aborden los retos del acceso a los medicamentos en todo el mundo.

A través de nuestro innovador programa de acceso global GIPAP (Glivec ® International Patient Assistance Program) inició en la India en 2002, hemos ayudado a más de 16.000 pacientes en India. La gran mayoría de los pacientes indio Glivec ®-más de 14.000 en la actualidad recibe el medicamento gratuitamente de Novartis. También queremos aclarar que sin limitación en número, cualquier paciente en la India cuyo médico determina que él o ella se beneficiaría de Glivec ® y pueden tener dificultades para pagar, puede obtener ayuda del programa de Acceso Novartis Oncology.

Otros programas de Novartis proporcionar asistencia con el reembolso y el co-pago, así como las donaciones de pleno derecho en la India y muchos otros países. Estamos introduciendo Novartis Oncology programas de acceso para la mayoría de nuestros medicamentos oncológicos.

Entendemos que el acceso a medicamentos de alta calidad es un componente clave de los esfuerzos globales para reducir el impacto de una enfermedad. La gente pobre de los países en desarrollo continuarán sufriendo innecesariamente hasta una amplia variedad de temas tales como la falta de diagnóstico, la infraestructura y la distribución se resuelven. Los gobiernos, las ONG y las empresas deben trabajar juntos para encontrar soluciones innovadoras ta estos temas. Como un esfuerzo tal Novartis ha puesto en marcha un proyecto de asistencia sanitaria nueva entrega en la India llamado Arogya Parivar (Familia Saludable) donde se busca llevar atención médica y medicinas a las zonas rurales. El programa ya ha alcanzado el 42 millones de indios en 28.000 aldeas de todo el país, y más de 250 educadores de la salud transmitir mensajes vitales sobre la conciencia de la salud y la prevención.

Como la segunda Iargest productor mundial de medicamentos genéricos, Novartis comprende y reconoce la contribución de los genéricos una vez que expiran las patentes de medicamentos. Sin embargo, los medicamentos genéricos por sí solas no resuelven el problema de acceso. La gran mayoría de los 354 medicamentos de la OMS de modellist de medicamentos esenciales no están cubiertos por patentes, sin embargo, más de un tercio de la población mundial todavía no tiene acceso a estos medicamentos esenciales. Tampoco el costo de los medicamentos genéricos resolver el problema. Genérico imatinib, que es y seguirá siendo disponible en la India con independencia del resultado de la acción legal, se considera todavía tao caro para la mayoría de la población de pacientes de la India. Con base en datos del Banco Mundial, el costo de un año de tratamiento en la India con genérico imatinib es de 4,5 veces el ingreso promedio anual.

Los pacientes en todo el mundo tienen un interés vital en innovadores fármacos eficaces no sólo Taday, sino también en el futuro. Para un sistema de salud sostenible basado en la investigación, los ingresos generados por un puñado de productos farmacéuticos en el mercado hoy en día tiene que generar los ingresos necesarios para apoyar todos los actuales y futuros patrocinados por la industria investigación de nuevos medicamentos.

En resumen, Novartis se ha comprometido plenamente a mejorar el acceso de los pacientes a nivel mundial como reconocidos recientemente en el Acceso a los Medicamentos Índice en 2010, donde Novartis ha sido clasificado N º 3. Al mismo tiempo nos esforzamos por sistemas de patentes sólidas y eficaces necesarias ta traer nuevos medicamentos al mercado. Creemos firmemente que nuestros esfuerzos de servir a las necesidades de los pacientes de hoy y mañana.

Esperamos haber proporcionado una mejor comprensión de nuestras preocupaciones.

 

 

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THANKS.


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