European Medicines Agency - Human Medicines - Referrals - Article 29 paediatric referrals

Human Medicines - Referrals
List of Referrals - Article 29 - 'paediatric referrals'
Background
Article 29 of Regulation (EC) No 1901/2006 begin_of_the_skype_highlighting 1901/2006 end_of_the_skype_highlighting as amended foresees that an application as referred to in article 8 of the said regulation can be submitted, in accordance with the procedure laid down in articles 32, 33 and 34 of Directive 2001/83/EC, for products authorised under Directive 2001/83/EC.

In this referral procedure, the marketing authorisation holders may apply for a new indication, a new pharmaceutical form or a new route of administration.

The application shall comply with the requirements laid down in point (a) of article 7(1) of Regulation (EC) No 1901/2006 begin_of_the_skype_highlighting 1901/2006 end_of_the_skype_highlighting, regarding the inclusion of the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan.

At the end of the referral, the CHMP opinion may contain a recommendation for some changes to the prescribing information (such as the Summary of Product Characteristics wording), for the approval of a new pharmaceutical form and/or a new route of administration. It can also contain some conditions to the marketing authorisation, to ensure the safe and effective use of the medicine in the paediatric population. The assessment is limited to the specific sections of the product information to be varied.

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European Medicines Agency - Human Medicines - Referrals - Article 29 paediatric referrals

European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Application guidance and related information

Human medicines - Orphan medicinal products
Orphan designation - Application guidance and related information

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European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Application guidance and related information

European Medicines Agency - Human Medicines - Medicines for children - EU paediatric network

Paediatric-related information
EU paediatric network
The Paediatric Regulation provides for the European Medicines Agency to develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population. An implementing strategy for the network has been adopted by the Agency's Management Board on 15 January 2008.

The Implementing Strategy for the launching and operation of the EU paediatric network can be found here.

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European Medicines Agency - Human Medicines - Medicines for children - EU paediatric network

European Medicines Agency - Human Medicines - Medicines for children - Workshops

Global cooperation
Workshops
2nd EMA workshop on European Paediatric Network Updated on lunes, 31 de mayo de 2010
16 March 2010
European Medicines Agency, London, UK

- Agenda
- Report
- Background and summary of outcome of first workshop on EnprEMA (Dr. Irmgard Eichler)
- Structure for the operation of the EnprEMA elaborated working group (Dr. Christina Peters)
- Recognition criteria elaborated by working group 2 (Dr. Nicola Ruperto)
- Presentation of comments received during public consultation (Dr. Emma Sala Soriano)
- Proposal of minimum criteria required for recognition (Dr. Ralf Herold)

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European Medicines Agency - Human Medicines - Medicines for children - Workshops

Telithromycin - EPARs for authorised medicinal products for human use - Ketek

FICHA FARMACOLÓGICA de Telithromycin . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 31, 2010.-

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EPARs for authorised medicinal products for human use - Ketek

Active Substance
Telithromycin
International Nonproprietary Name or Common Name
Telithromycin
Pharmaco-therapeutic Group
macrolides, lincosamides and streptogramins
ATC Code
JO1FA15

Therapeutic Indication:
When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agentsand the local prevalence of resistance.

Ketek is indicated for the treatment of the following infections:

In patients of 18 years and older:
• Community-acquired pneumonia, mild or moderate

• When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin.
- Acute exacerbation of chronic bronchitis,
- Acute sinusitis

In patients of 12 years and older:
•Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA.


Date of issue of Marketing Authorisation valid throughout the European Union
9 July 2001

Orphan medicinal product designation date
Not applicable


Authorised Medicines for Human Use

doripenem monohydrate - EPARs for authorised medicinal products for human use - Doribax

FICHA FARMACOLÓGICA de doripenem monohydrate . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 31, 2010.-

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EPARs for authorised medicinal products for human use - Doribax

Active Substance
doripenem monohydrate
International Nonproprietary Name or Common Name
doripenem
Pharmaco-therapeutic Group
Carbapenem antibiotics
ATC Code
(J01DH04)

Therapeutic Indication:
Doribax is indicated for the treatment of the following infections in adults (see SPC sections 4.4 and 5.1):

Nosocomial pneumonia (including ventilator–associated pneumonia)
Complicated intra-abdominal infections
Complicated urinary tract infections.


Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Date of issue of Marketing Authorisation valid throughout the European Union
25 July 2008


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use

retapamulin - EPARs for authorised medicinal products for human use - Altargo

FICHA FARMACOLÓGICA de retapamulin . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 31, 2010.-

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EPARs for authorised medicinal products for human use - Altargo

Active Substance
retapamulin
International Nonproprietary Name or Common Name
retapamulin
Pharmaco-therapeutic Group
Dermatologicals
ATC Code
D06AX13

Therapeutic Indication:
Short term treatment of the following superficial skin infections:

Impetigo.

Infected small lacerations, abrasions, or sutured wounds.

See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.


Date of issue of Marketing Authorisation valid throughout the European Union
24 May 2007


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use

DIRECTORIO DE DOCUMENTOS EDITADOS EN MAYO 2010

DIRECTORIO DE DOCUMENTOS EDITADOS EN MAYO 2010

CIENCIAS MÉDICAS NEWS
CIENCIAS MÉDICAS APLICADAS
RESEARCH & CLINICAL DEVELOPMENT

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Consultas acumuladas desde enero 2009 a la fecha: 187.274
Discriminadas como sigue:
1. ESPAÑA: 30.114 [16,1%]
2. ARGENTINA: 30.037 [16,0%]
3. MÉXICO: 26.455 [14,1%]
4. U.S.A.: 18.881 [10,1%]
5. COLOMBIA: 11.157 [6.0%]
6. VENEZUELA: 10.864 [5,8%]
7. PERÚ: 10.683 [5,7%]
8. CHILE: 6.583 [3,5%]
9. ECUADOR: 4.672 [2,5%]
10. BOLIVIA: 3.456 [1,8%]
11. LOS DEMÁS: 34.372 [18.4%]
Total de consultas: 187.274


Documentos del mes de MAYO: 607
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Documentos editados desde el inicio del blog: 6.981

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GASTROENTERITIS, BROTE MASIVO REGIONAL - CHILE (ANTOFAGASTA) (03)

GASTROENTERITIS, BROTE MASIVO REGIONAL - CHILE (ANTOFAGASTA) (03)

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
http://www.isid.org

Fecha: 27 de mayo, 2010
Fuente: El Mercurio, Chile
http://www.mercurioantofagasta.cl/prontus4_noticias/site/artic/20100527/pags/20100527000516.html [Editado por J. Torres]

Después de dos meses de especulaciones, el Instituto de Salud Pública (ISP) confirmó ayer que el brote de norovirus que afectó a cerca de 30 mil personas en la región tuvo su origen en el agua servida tratada que la planta Bayesa S.A. vende a los agricultores de La Chimba.

Diez muestras de agua recogidas el 27 y 28 de abril en las plantas de tratamiento del Salar del Carmen, Bonilla y Bayesa S.A., además de domicilios particulares, permitieron descartar el norovirus en las fuentes de agua potable y, a la vez, confirmar su presencia en el líquido tratado que entrega la sanitaria para el riego de verduras y hortalizas.

Los estudios fueron realizados por la seremi de Salud y el ISP con la colaboración de la Food and Drug Administration (FDA) de Estados Unidos.

Cuando se confirmó que el norovirus era el agente que causó el masivo brote gastrointestinal, a fines de marzo, las autoridades elaboraron una serie de hipótesis para explicar la aparición del agente. Ninguna teoría, sin embargo, fue concluyente.
El ISP es el que ahora despeja el panorama y entrega una explicación de lo que ocurrió.

"Estos resultados de laboratorio permiten establecer una relación entre el brote en la población, el agua de una de las plantas de tratamiento de aguas servidas para riego de Antofagasta y el agua de mar, configurándose así una recirculación del agente que habría contribuido a la magnitud del brote en la comunidad", sostiene el
organismo en un comunicado.

En su informe, el Instituto de Salud Pública destaca que las fuentes de agua potable--- están limpias de norovirus, agente que causa males gastrointestinales y se contagia de persona a persona.

Al respecto, la directora del ISP, Ingrid Heitmann, afirmó que "los resultados nos permiten tranquilizar a la población sobre el agua que consume", al tiempo que constituyen "un llamado de atención para que la planta de tratamiento mejore sus procesos".

Salud instruyó un sumario sanitario a Bayesa tras detectar que redujo la cloración en el tratamiento de las aguas servidas usadas para regar cultivos en La Chimba y aplicó una multa de 500 UTM. Además, aún mantiene la prohibición de suministro sobre la sanitaria.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]
-- ProMED-ESP

[Ver también:
Gastroenteritis, brote masivo regional - Chile (Antofagasta) (02) 20100412.1193
Vibrio cholerae, caso clinico - Chile (Antofagasta) 20100406.1105
Gastroenteritis, brote masivo regional - Chile (Antofagasta) 20100327.0963]

-----
ProMED-mail
...jt
*##########################*
ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
****************************

DENGUE, CASOS, MUERTES: ACTUALIZACIÓN - LATINO AMÉRICA

DENGUE, CASOS, MUERTES: ACTUALIZACIÓN - LATINO AMÉRICA

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
http://www.isid.org

Fecha: 28 de mayo, 2010
Fuente: Globovisión
[Editado por J. Torres]

Un nuevo brote de dengue, en sus variedades tanto clásica como hemorrágica, que algunos expertos achacan a la proliferación de lluvias en Latinoamérica, se ha cobrado 239 vidas en la región en lo que va de año, al tiempo que 131.415 personas han resultado contagiadas.

El país con el mayor número de decesos a causa de la enfermedad, que transmite el mosquito "Aedes aegypti", es Brasil, que entre enero y abril últimos contabilizó 117, según el ministerio de Salud que no informó acerca del número de infectados. En esa materia, Venezuela, con 21.153 casos, se ubica segundo por detrás de Colombia (77.405), toda vez que la epidemia afecta a 14 de los 23 estados del país.

Colombia le sigue en cantidad de muertes, que a la fecha suman 75 desde que comenzó 2010, mientras que otros 38 casos de pacientes fallecidos se encuentran en estudio, según un informe del Ministerio de la Protección Social.

A su vez, este país andino encabeza la lista de los que mayores contagios registra, con 77.405 casos, de los cuales 71.815 son de la variedad clásica y 5.590 de la hemorrágica.

El último análisis del Instituto Nacional de Salud (INS), publicado el pasado 25 de mayo, señala que hasta la fecha los menores de 15 años son los más afectados y que representan un 40 por ciento del total de los casos confirmados.

El brote ha golpeado también de manera importante en República Dominicana y se ha cobrado 16 vidas en este año. Además hay 2.600 contagiados, entre ellos 350 de la variedad hemorrágica, que puede ser mortal.

Paraguay sigue en la lista con un total de 14 personas fallecidas y 7.500 contagiadas este año, particularmente en los departamentos de Amambay, Concepción y Alto Paraná, todos en la frontera con Brasil, así como en Asunción, lo que llevó al Gobierno a declarar la alerta epidemiológica desde el pasado 1 de febrero.

Perú también se declaró en alerta el pasado 22 de mayo tras la muerte de tres personas que padecían de dengue hemorrágico, y las cuentas de las autoridades sanitarias ya llegan a la cifra de 2.300 casos solo en la región de Piura, fronteriza con Ecuador.

El Gobierno peruano también dio parte de que la región de Tumbes presenta un importante registro de contagios, con 404 del clásico y cuatro más del hemorrágico.

A su turno, Ecuador reportó la muerte de dos personas, cifra similar a la suministrada por el Departamento de Salud de Puerto Rico, que no detalló la cifra de contagios.

En lo que concierne a muertes en Centroamérica, Honduras registra siete, mientras que en Guatemala son tres. Según el ministro guatemalteco de Salud, Ludwig Ovalle, se investiga otro caso para establecer si la muerte se debió a esta enfermedad.

En el resto de países latinoamericanos, entre tanto, hay casos de dengue pero ninguno ha resultado letal hasta ahora.

Ecuador, a su vez, reportó de manera oficial que la cifra llega a 5.036 casos entre enero y marzo, al tiempo que en Argentina, que en 2009 sufrió la mayor epidemia de dengue de su historia, los casos se han reducido un 96 por ciento este 2010.

Así las cosas, según datos del Ministerio de Salud de Argentina, la estrategia de prevención del dengue aplicada este año permitió reducir a 1.046 los casos, frente a los más de 26.000 que se contaron en 2009, cuando también se dieron cinco muertes.

Por cantidad de contagios este año, la cifra desciende aún más en Bolivia frente a otros países de la región.

En ese país las autoridades sanitarias señalaron que hasta la primera quincena de mayo se han confirmado 608 casos de dengue, aunque alertaron de que hay otros 4.726 más sospechosos, luego de que entre enero y febrero se registró un rebrote de la enfermedad, aunque menor a la de 2009, cuando se detectaron unos 50.000 casos del tipo clásico y 22 personas murieron.

En Cuba, la "quiebra huesos", como también es conocida la enfermedad en la región, ha afectado a 19 personas este año, según los datos más recientes.

En la actualidad, 10 de las 14 provincias de la isla están libres del mosquito trasmisor del dengue, pero las autoridades sanitarias insisten en el rigor de las campañas de prevención.

Honduras, con 7.000 caos del clásico y 286 más del hemorrágico, así como El Salvador, con 4.673 casos, 76 de ellos de la variedad letal, son los países de Centroamérica con mayor número de contagios. Los contagios en Guatemala totalizan este año 381, 89 de ellos del tipo hemorrágico, lo que representa un incremento de 386,6 por ciento
con relación al mismo periodo de 2009.

En términos generales el Gobierno de Chile no detalló cifras de muertes ni de contagiados con el dengue durante lo que va de 2010, y calificó como "muy aislados" e "importados" desde otros países de la región los pocos contabilizados, toda vez que el país está declarado libre del vector desde 1961 por la Organización Panamericana de la Salud (OPS).

La Secretaría de Salud de México no ha facilitado datos de este año. En 2009 se registraron en este país 50.000 casos de dengue, de los cuales 17 mortales.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]
-- ProMED-ESP
...jt
*##########################*
ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
****************************

MALARIA, NUESVA ESPECIE TRANSMISORA - COLOMBIA (PUTUMAYO)

MALARIA, NUESVA ESPECIE TRANSMISORA - COLOMBIA (PUTUMAYO)

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
http://www.isid.org

Fecha: 28 de mayo, 2010
Fuente: RTVCY http://www.rtvcyl.es/fichaNoticia.cfm/CIENCIA/20100528/hallan/nuevo/mosquito/responsable/malaria/DDAE287F-C7D6-1D65-A8D912AE54E2BF2C [Editado por J. Torres]

Entomólogos de la Universidad Nacional (UN) de Colombia hallaron una nueva especie de mosquito transmisor de malaria en el departamento del Putumayo.

Los expertos en insectos advierten que es tan abundante, que requiere medidas urgentes por parte de las entidades de salud. Su estudio es un aporte al conocimiento mundial. Actualmente el país reconoce que existen entre 40 y 47 especies de mosquitos _ Anopheles_, de las cuales 7 han sido incriminadas como vectores portadores de malaria.

Tres de ellas se catalogan como transmisores principales porque están distribuidas en la mayor parte del territorio, no solo de Colombia sino de América Latina.

Lo que resulta curioso es que en el Putumayo, estos tres vectores no están presentes, según estudios adelantados por el Grupo de Investigación en Entomología de la Universidad Nacional de Colombia.

Sin embargo, este departamento aparece catalogado como de alto riesgo por su incidencia en malaria. Entonces, ¿qué está causando la transmisión de la enfermedad en dicha zona del país? Con esta pregunta, los científicos, encabezados por la profesora Martha Quiñones, iniciaron en el año 2006 un proyecto de investigación
financiado por Colciencias, con la intención de determinar el papel como vectores de malaria de las especies de Anopheles, no solo en Putumayo sino en Meta y La Guajira.

Cuatro años más tarde pudieron confirmar la existencia de una nueva variedad de mosquito que antes se había confundido con otras especies como _Anopheles noroestensis_ y _A. evansae_. A través de técnicas moleculares, el análisis de su morfología y los aspectos de su comportamiento, se determinó que se trataba de una especie nueva. Por ahora se le llama _A. benarrochi_ .

Las pesquisas comenzaron en estas tres regiones de frontera debido a que estudios anteriores expusieron una urgente problemática: especies de _Anopheles_ incriminadas como importantes vectores de malaria en países vecinos, como las del complejo _A. oswaldoi_ en Brasil y _A. aquasalis_ en Venezuela, aún no eran consideradas vectores en Colombia.

"En principio no hay ninguna razón aparente para que una misma especie de _Anopheles_ sea capaz de transmitir malaria en un sitio y solo por cruzar la frontera deje de hacerlo", argumenta la investigadora Quiñones.

Con la colaboración de los servicios de salud de la zona, se realizaron capturas de mosquitos _Anopheles_ en las tres regiones, durante varias noches y en diferentes épocas de los años 2007 a 2009. De igual manera se ubicaron los sitios de cría de los insectos. Tras someterlos a todas las técnicas inmunológicas y genéticas, los
resultados permitieron, entre otras cosas, la identificación de 11 especies en Putumayo.

De las 11 especies halladas en Putumayo, a primera vista la más predominante parecía ser _A. benarrochi_, muy común en Perú, pero este hallazgo no tenía lógica porque el _A. benarrochi_ (clásico) ya se había detectado en Colombia, pero no era portador de la infección de _Plasmodium_ y, además, no es cercano a la gente, pues se alimenta la
mayoría de veces con sangre de animales.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]
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...jt
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ProMED-mail hace el máximo esfuerzo posible para verificar los informes que incluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
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KLEBSIELLA PNEUMONIA, MUERTES, RECIEN NACIDOS - MÉXICO (MONTERREY)

KLEBSIELLA PNEUMONIA, MUERTES, RECIEN NACIDOS - MÉXICO (MONTERREY)

Un comunicado de ProMED-mail
http://www.promedmail.org
ProMED-mail es un programa de la Sociedad Internacional de Enfermedades Infecciosas
http://www.isid.org

Fecha: 26 de mayo, 2010
Fuente: Tribuna de Campeche, México
http://www.tribunacampeche.com/index.php?option=com_content&view=article&id=21753:mueren-5-bebes-por-extrana-infeccion&catid=30:primeraplana&Itemid=47 [Editado por J. Torres]

El Instituto Mexicano del Seguro Social (IMSS) confirmó ayer la muerte de cinco recién nacidos en la última semana a causa de una infección contraída durante el tiempo en el que permanecieron internados en la unidad de Cuidados Intensivos Neonatales en la Clínica 6 de San Nicolás.

Mediante un comunicado, la Delegación del IMSS dijo que los bebés contagiados con una cepa de _klebisella pneumoniae_ fueron seis en total, de los cuales cinco perdieron la vida. El organismo no especificó de qué manera afecta a los neonatos. Francisco Salazar Leal, jefe de Comunicación Social de la Delegación, señaló ayer que entre el 20 y el 24 de mayo, especialistas del nosocomio detectaron el padecimiento en seis de 17 menores prematuros que se encontraban internados en el área de terapia intensiva del hospital, ubicado en el Centro de San Nicolás, Municipio ubicado en la zona metropolitana de Monterrey. Añadió que el pasado 20 de mayo se registraron las tres
primeras muertes y en los días subsecuentes las otras dos. El funcionario señaló que tras conocerse el brote, especialistas del IMSS de la Ciudad de México se trasladaron a Monterrey para encabezar las investigaciones.

Como primera medida ordenaron poner en cuarentena a los infantes que estuvieron expuestos y suspender temporalmente los ingresos en el área contaminada. Como medida preventiva se habilitaron espacios en otras áreas del hospital y se estableció una férrea vigilancia epidemiológica entre los menores que se encuentran en el nosocomio.
Salazar Leal descartó que estén expuestos al padecimiento otros pacientes internados en el lugar, y consideró que en breve será "contenido" el brote infeccioso.
Comunicado por: Jaime R. Torres [torresjaime@cantv.net]
-- ProMED-ESP
...jt
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ProMED-mail hace el máximo esfuerzo posible para verificar los informes queincluimos en nuestros envíos, pero no garantiza la exactitud ni integridad de la información, ni de cualquier aseveración u opinión basadas en ella. El lector debe asumir todos los riesgos incurridos al utilizar la información incluida o archivada por ProMED-mail. La Sociedad Internacional de Enfermedades Infecciosas (International Society for Infectious Diseases, ISID) y los proveedores de servicio asociados a ella no serán responsables por errores u omisiones, ni sujetos a acción legal por daños o perjuicios incurridos como resultado del uso o confianza depositados en el material comunicado o archivado por ProMED-mail.
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CDC - Summary Data Report - HAI

First State-Specific Healthcare-Associated Infections Summary Data Report CDC’s National Healthcare Safety Network (NHSN) January-June, 2009

The U.S. Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion is the government agency charged with tracking and preventing healthcare-associated infections in healthcare facilities such as hospitals, long-term care facilities and outpatient medical facilities. Healthcare facilities report infections directly into CDC’s monitoring system called National Healthcare Safety Network either voluntarily or because their state requires reporting of one or more infection type.

Information collected through NHSN includes central-line associated infections, catheter-associated urinary tract infections, surgical site infections, ventilator-associated pneumonia, blood transfusion infections and more. Many different types of healthcare facilities from every state in the country report to NHSN.

CDC scientists have studied this information and reported on national HAI infection trends [PDF - 5.37 MB: http://www.cdc.gov/nhsn/PDFs/dataStat/2009NHSNReport.pdf"]. This information is then used to identify, test and help implement HAI prevention strategies that work.

The First State-Specific HAI Summary Data Report [PDF - 793 KB: http://www.cdc.gov/hai/pdfs/stateplans/SIR_05_25_2010.pdf], the first in a series, represents the first time CDC has reported state-specific infection information. This initial report includes both national central line-associated bloodstream infection (CLABSI) data and state-specific data for states mandated by state law to report CLABSIs. Ideally, future reports will include other infection types and data from all states.

Based on the information in this report series, and supported by funding through the American Reinvestment and Recovery Act, CDC is enhancing its work with state health departments. The Agency is proactively offering technical support and strategic assistance to states interested in beginning or improving infection prevention programs. Data presented in the report series will also help measure progress toward the infection prevention goals in the U.S. Department of Health and Human Services HAI Action Plan [PDF - 2.27 MB - http://www.hhs.gov/ophs/initiatives/hai/draft-hai-plan-01062009.pdf].

Abbreviation key:
CDC = U.S. Centers for Disease Control and Prevention
HHS = U.S. Department of Health and Human Services
HHS Action Plan = U.S. Department of Health and Human Services Action Plan to Prevent Healthcare-Associated Infections
NHSN = National Healthcare Safety Network
Recovery Act = American Reinvestment and Recovery Act
SIR = Standardized Infection Ratio

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CDC - Summary Data Report - HAI

PediaCare Children's Products [Blacksmith Brand]: Recall of four products

PediaCare Children's Products [Blacksmith Brand]: Recall of four products
PediaCare Multi-Symptom Cold
PediaCare Long Acting Cough
PediaCare Decongestant
PediaCare Allergy and Cold
Audience: Consumers,, Pediatrics healthcare professionals
Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant.
The four PediaCare items involved in the recall are:
PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4

Blacksmith Brands initiated the recall as a precautionary step because the products were manufactued at a McNeil plant in which a recent FDA inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm

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PediaCare Children's Products [Blacksmith Brand]: Recall of four products

Intravenous Medications Manufactured by Claris: Recall due to contamination of products

Intravenous Medications Manufactured by Claris: Recall due to contamination of products
Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.
Audience: Pharmacists, Hospital Risk Managers
FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products.
Read the complete MedWatch 2010 Safety summary, including a link to the Public Health alert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214034.htm

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Intravenous Medications Manufactured by Claris: Recall due to contamination of products

Cancer News: Patients Now Living Longer with Chronic Myeloid Leukemia due to Improved Testing

Cancer News: Patients Now Living Longer with Chronic Myeloid Leukemia due to Improved Testing

For people with Chronic Myeloid Leukemia (CML), critical test results can get lost in translation. "Currently if a patient’s blood sample is sent to two different labs, both may yield different results,” says Dr. Shashi Pawar, Director of Genetics for Acupath Laboratories, Inc. Dr. Shashi Pawar on issues and advances in CLM testing.

Plainview, NY (PRWEB) May 22, 2010 -- For people with Chronic Myeloid Leukemia (CML), critical test results can get lost in translation. “Currently if a patient’s blood sample is sent to two different labs, both may yield different results,” says Dr. Shashi Pawar, Director of Genetics for Acupath Laboratories, Inc. Acupath is accredited by the Joint Commission and College of American Pathologists and is a leader in providing physicians and patients with accurate and innovative pathologic, molecular and cytogenetic analyses.

This discrepancy is vexing enough that U.S. laboratories began a revolutionary push to standardize the Polymerase Chain Reaction PCR (PCR) test for CML last year. “In order to monitor progress, there should be consistency,” says Dr. Pawar. She recommends that until the metric is harmonized, patients and doctors use the same laboratory for each analysis. For over three years Acupath has been offering the BCR/ABL1 RT-PCR, one of the most advanced and sensitive tests for monitoring leukemia cells.

What is CML and who is at risk?
Many people with Chronic Myeloid Leukemia (CML) do not have symptoms when it is diagnosed. The leukemia is often found when their doctor orders blood tests for an unrelated health problem or during a routine checkup. The leukemia cells tend to build up gradually, which is why symptoms may not manifest for a few years.

Chronic myeloid leukemia (CML), also known as chronic myelogenous leukemia, is a cancer that starts in the blood-forming cells of bone marrow. It then moves into the blood and can spread to other parts of the body. Most cases of CML occur in adults; 67 is the median age at diagnosis. Last year in the United States, 5,050 people were diagnosed with CML. Few patients qualify for a bone marrow transplant to treat the disease, which used to have an average survival rate of two years.

However, since the approval of new molecularly-targeted treatments, this formerly fatal cancer has become a manageable chronic condition with a five-year survival rate that approaches 90 percent. Furthermore, one very important reason why the CML is monitored is because of the invention of a wonder drug called Gleevac. With this, patients have the hope to survive many years, even more than ten years, without bone marrow transplant. With this test, doctors can monitor the efficacy of Gleevac.

How does the BCR/ABL1 RT-PCR test work?
CML patients have what is called the "Philadelphia Chromosome" (Ph chromosome). The BCR/ABL1 RT-PCR is a molecular test that measures this chromosomal abnormality, which is called the BCR-ABL1 gene. Most CML specialists opt for a QT-RT PCR. PCR means Polymerase Chain Reaction, RT stands for Real Time and QT means Quantitative, meaning it can quantify how many cells are affected by the mutation. A qualitative PCR merely returns a positive or negative answer. The BCR/ABL1 RT-PCR is an ultra-sensitive diagnostic tool: Molecular Geneticist can see one leukemia cell in as many as a million normal cells, even when doctors can't find the Philadelphia chromosome in bone marrow cells with genetic testing.

The results are very useful for illustrating trends, whether progress or retrogression. One recent advance is that many labs now give the logarithmic reduction, meaning the level of disease that existed during diagnosis, along with the current percentage of leukemia cells.

Why do the outcomes vary?
Because PCR results are not a ratio of leukemic cells to good cells, the test doesn’t provide a total percentage of leukemic cells in the body. Depending on which control genes are used, findings can vary from one lab to another. Another disparity manifests because the test must be done as soon as possible on the specimen to ensure the most accurate report.

Many labs in Europe and other countries use an International Scale. Early last year, some U.S. labs started this conversion so changes in the PCR numbers may be due to a change in reporting methods. That differential is another reason Dr. Pawar recommends consistency when choosing a lab so disease trends can be accurately monitored. It is also important when switching labs to have a new baseline test done.

Monitoring the disease with regular testing
“The BCR/ABL1 RT-PCR test provides the earliest possible diagnosis, the fastest detection of residual disease during treatment, and the most accurate method of tracking patients in remission,” says Dr. Pawar. Advancements in the test allow doctors to identify abnormalities in the malignancy’s initial stage, which offers a better prognosis since treatment can begin before the cancer advances.

Dr. Pawar advises it be performed every few months during treatment to assess response to therapy. Doctors can then track reductions in disease levels and determine if a patient’s dosage or treatment needs to be adjusted.

About Dr. Shashi Pawar: A diplomat of the American Society of Human Genetics and member of the Association of Molecular Pathology, Dr. Shashi Pawar serves as director of Genetics for Acupath Laboratories, Inc. Her more than 20 of experience in molecular genetics and molecular pathology includes working as a consultant for the Center for Human Genetics in Cleveland; a technical director of Genova Diagnostics; and holding several diagnostic laboratory directorships. Published in dozens of selective medical journals, her educational background includes a Ph.D. in biochemistry from City University of New York. She also served a clinical molecular genetics fellowship at Yale University and a clinical cytogenetics fellowship at Columbia University.

Acupath Laboratories, Inc. located in Plainview, New York, is an anatomic pathology and cancer genetics laboratory. www.acupath.com

Cancer News: Patients Now Living Longer with Chronic Myeloid Leukemia due to Improved Testing

PHG Foundation | World Health Assembly focus on birth defects

World Health Assembly focus on birth defects
27 May 2010 | By Dr Philippa Brice | News story

Delegates at the sixty-third World Health Assembly, a major international meeting between senior World Health Organization (WHO) officials and national Health Ministers held in Geneva last week, voted to adopt a range of resolutions relating to public health around the world. These included a resolution to address the problem of birth defects, especially in low- and middle-income countries, calling on Member States ‘to prevent birth defects wherever possible, to implement screening programmes, and to provide ongoing support and care to children with birth defects and their families’ (see press release).

The PHG Foundation is already engaged in a major project to tackle birth defects, also known as congenital anomalies or abnormalities – a wide range of conditions that are present from birth, ranging from genetic and chromosomal disorders through to physical malformations. The majority of birth defects are caused by genetic factors, though environmental factors can also cause or exacerbate them. The PHG Foundation has developed a special toolkit to help low and middle-income countries (where birth defects account for a significant proportion of child deaths and ongoing disability) assess their health needs and develop simple, effective services to prevent and care for this range of conditions. The toolkit is tpo be piloted in different international locations over the coming two years. The PHG Foundation is also working with external partners including the WHO on efforts to create and drive forward concerted global efforts to share expertise and resources in order to reduce the suffering associated with birth defects.
PHG Foundation | World Health Assembly focus on birth defects

Human microbiome project: Diversity of human microbes greater than previously predicted

Human Microbiome Project: Diversity of Human Microbes Greater Than Previously Predicted
ScienceDaily (May 21, 2010) — The Human Microbiome Project (HMP) has published an analysis of 178 genomes from microbes that live in or on the human body. The researchers discovered novel genes and proteins that serve functions in human health and disease, adding a new level of understanding to what is known about the complexity and diversity of these organisms.
The human microbiome consists of all the microorganisms that reside in or on the human body. Outnumbering cells in the human body by 10 to 1, some of the microorganisms cause illnesses, but many are necessary for good health. Currently, researchers can grow only some of the bacteria, fungi and viruses in a laboratory setting. However, new genomic techniques can identify minute amounts of microbial DNA in an individual and determine its identity by comparing the genetic signature to known sequences in the project's data base.

The paper is published in the May 21 issue of the journal Science.

"This initial work lays the foundation for this ambitious project and is critical for understanding the role that the microbiome plays in human health and disease," said National Institutes of Health Director Francis S. Collins, M.D., Ph.D. "We are only at the very beginning of a fascinating voyage that will transform how we diagnose, treat and ultimately, prevent many health conditions."

Launched in 2008 as part of the NIH Common Fund's Roadmap for Medical Research, the HMP is a $157 million, five-year effort that will implement a series of increasingly complicated studies that reveal the interactive role of the microbiome in human health.

The 178 microbial genomes in this report launch the HMP reference collection that eventually will total approximately 900 microbial genomes of bacteria, viruses and fungi. These data will then be used by HMP researchers to characterize the microbial communities found in samples taken from healthy human volunteers and, later, those with specific illnesses. Samples are currently being collected for HMP from five areas of the body: the digestive tract, the mouth, the skin, the nose and the vagina.

"Although this is only the first step in making HMP medically useful, we already have learned surprising things about the diversity and complexity of the microorganisms that live in and on our body," said Jane Peterson, Ph.D., associate director of the NHGRI Division of Extramural Researcher and a leader of the HMP effort. "The next stages of this coordinated study will begin to associate the presence or absence of specific micro-organisms with various states of health and illness."

Researchers also conducted a preliminary survey to gain insights into the function of some of the newly identified genes and proteins unique to individual microbial strains. For instance, researchers found previously unknown proteins produced by bacteria that live in the stomach that may cause gastric ulceration, a hole in the stomach lining. In addition, they found a small number of newly identified novel proteins associated with how sugars and amino acids are metabolized.

Researchers also evaluated the microbial diversity present in the HMP reference collection. For example, they found 29,693 previously undiscovered, unique proteins in the reference collection -- more proteins than there are estimated genes in the human genome. They compared their results to the same number of previously sequenced microbial genomes randomly selected from public databases. In the microbial genome from public databases, they found 14,064 novel proteins. These data, the researchers say, suggest that the HMP reference collection has nearly twice the amount of microbial diversity than is represented by microbial genomes already in public databases.

One of the primary goals of the HMP reference collection is to expand researchers' ability to interpret data from metagenomic studies. Metagenomics is the study of a collection of genetic material (genomes) from a mixed community of organisms. Comparing metagenomic sequence data with genomes in the reference collection can help researchers determine whether they are novel or already existing sequences.

To evaluate whether the reference collection of genomes was meeting the goal above, the researchers compared 16.8 million microbial sequences found in public databases to the genome sequences in the HMP reference collection. They found that 62 genomes in the reference collection showed similarity with 11.3 million microbial sequences in public databases and 6.9 million of these -- about 41 percent -- correspond with genome sequences in the reference collection.

This analysis demonstrates that genomes sequenced as part of the reference collection add directly to an understanding of the human microbiome. However, researchers cautioned that at least one-third of the metagenomic sequences are still not represented by any genome in the reference collection and that this analysis focused only on the gastrointestinal tract. The authors added that additional genomes likely exist in other body sites and the completion of the reference collection should address many of the remaining organisms not accounted for in this analysis.

The initial stage of the HMP, which includes the current study, focused on bacteria, but future genome sequencing and human microbiome studies also will capture information about more complex microbes and viruses. The effort so far also has allowed researchers to create a framework for data resources and standards. In addition, the project is supporting the development of innovative technologies and computational tools, coordination of data analysis, and an examination of some of the ethical, legal and social implications of human microbiome research.

Genome sequencing work for the project is done by the HMP-funded large-scale sequencing centers: the Human Genome Sequencing Center, Baylor College of Medicine, Houston; Washington University Genome Sequencing Center, Washington University School of Medicine, St. Louis; The J. Craig Venter Institute, Rockville, Md.; and the Broad Sequencing Platform, Broad Institute of MIT/ Harvard, Cambridge, Mass.

The HMP is currently funding pilot demonstration projects by researchers that will sample the microbiomes of healthy volunteers and volunteers with specific diseases over the next year. This will allow researchers to study changes in the microbiome at particular body sites in healthy controls compared to patients affected by diseases. These studies will use samples collected from seven areas of the body: the digestive tract, the mouth, the skin, the nose, the vagina, the blood and the male urethra.

Genomes sequenced as part of the HMP and those generated by unrelated projects are publicly available from the National Library of Medicine's National Center for Biotechnology Information, part of NIH, at http://www.ncbi.nlm.nih.gov/genomes/MICROBES/microbial_taxtree.html. HMP data may also be accessed from its Data Analysis and Coordination Center website, http://hmpdacc.org/.

More information about the Human Microbiome Project is available at www.nihroadmap.nih.gov/hmp/.
Human microbiome project: Diversity of human microbes greater than previously predicted