CO-TRIMOXAZOL

Información principal

  • Denominación comercial:
  • CO-TRIMOXAZOL
  • formulario farmacéutico:
  • Inyección IV
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.


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Localización

  • Disponible en:
  • CO-TRIMOXAZOL
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m11056j01
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

CO-TRIMOXAZOL

Forma farmacéutica:

Inyección IV

Fortaleza:

Presentación:

Estuche por 5 ó 50 ampolletas de vidrio

ámbar con 5 mL cada una.

Titular del Registro Sanitario, país:

EMPRESA LABORATORIOS AICA,

LA HABANA, CUBA.

Fabricante, país:

EMPRESA LABORATORIOS AICA,

LA HABANA, CUBA.

Número de Registro Sanitario:

M-11-056-J01

Fecha de Inscripción:

21 de abril de 2011.

Composición:

Cada ampolleta contiene:

Sulfametoxazol

Trimetoprim

400,0 mg

80,0 mg

propilenglicol

sulfito de sodio anhidro

2,75 g

2,50 mg

EDTA sódico. 2H20

agua para inyección c.s.p.

Plazo de validez:

48 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C.

Protéjase de la luz.

Indicaciones terapéuticas:

La terapia parenteral

emplea

para

tratamiento

infecciones

causadas

gérmenes

sensibles

co-trimoxazol (combinación de la trimetoprima y sulfametoxazol), en procesos infecciosos

graves o complicados, cuando no sea posible la utilización de la vía oral.

Infecciones de los riñones y tracto urinario no complicadas como (Escherichia coli, Klebsiella,

Enterobacter, Proteus mirabilis, Proteus vulgaris. Su espectro de actividad antibacteriana a este

nivel incluye a los agentes patógenos comunes con excepción de la Pseudomonas aeruginosa.

Infecciones de las vías aéreas inferiores y superiores como otitis media aguda en niños debida

a cepas susceptibles de Haemophilus influenzae o Streptococcus neumoniae cuando a juicio

del médico ofrezca algunas ventajas sobre el uso de otros agentes antimicrobianos; bronquitis

aguda y crónica.

Profilaxis de neumonía causada por Pneumocystis carinii, en pacientes inmunodeprimidos tanto

en niños como en adultos. Tratamiento de neumonía por Pneumocystis carinii.

Infecciones del tracto gastrointestinal como tifus y paratifus, disentería bacilar, gastroenteritis

por cepas enterotoxigénicas de Escherichia coli y Vibrio cholerae, diarrea del turista, cólera

(como medida complementaria de la terapéutica para la sustitución de líquidos y electrólitos),

enteritis debida a cepas susceptibles Shigella flexneri y Shigella sonnei cuando la terapéutica

antibacteriana está indicada.

Otras

infecciones

bacterianas

como

osteomielitis

aguda

crónica,

brucelosis

aguda,

septicemias

causadas

gérmenes

sensibles,

tratamiento

nocardiosis,

tratamiento

profilaxis de toxoplasmosis.

Contraindicaciones:

Hipersensibilidad a la trimetoprima o a las sulfonamidas.

Embarazo a término.

Lactancia.

Niños prematuros y recién nacidos durante las primeras semanas de vida (1 meses).

Insuficiencia hepática severa.

Insuficiencia renal severa.

Porfiria.

Pacientes con déficit congénito de glucosa-6-fosfato-deshidrogenasa.

Precauciones:

Evitar conducir o manejar maquinarias peligrosas.

Advertencias especiales y precauciones de uso:

Adulto mayor: se incrementa el riesgo de ocurrencia de reacciones adversas. En personas con

daño renal hay que ajustar dosis según aclaramiento de creatinina, puede causar necrosis

tubular y nefritis intersticial (evitar si es severa)

Para reducir a un mínimo el peligro de efectos indeseables, el tratamiento deberá durar lo

menos posible, sobre todo en pacientes encamados.

En pacientes con daño hepático se debe ajustar dosis (evitar si es severo).

El cotrimoxazol presenta hipersensibilidad cruzada con furosemida, tiazidas, sulfonilureas e

inhibidores de la anhidrasa carbónica.

Evitar exposición a la luz ultravioleta o solar por riesgo de fotosensibilidad.

Precaución en estados que predisponen a deficiencia de folatos como alcoholismo, terapéutica

con anticonvulsivantes, síndrome de malabsorción y malnutrición.

Evitar en caso de discrasias sanguíneas y en pacientes con déficit de glucosa 6-fosfato

deshidrogenada (riesgo de hemólisis).

Puede ocasionar hiperkaliemia, por lo que debe vigilarse el potasio sérico principalmente en

pacientes con compromiso de la función renal, con afectación del metabolismo del potasio y

que consuman fármacos ahorradores de potasio.

Suspender el uso si aparece rash cutáneo.

Sustancia de uso delicado que sólo debe ser administrada bajo estricta vigilancia médica.

No se administre por vía intramuscular. No administrar sin haberse diluido previamente.

El uso prolongado o indiscriminado puede ocasionar la aparición de gérmenes resistentes y

colitis pseudomembranosa.

En caso de aparecer dolor de garganta, fiebre, petequias, hematomas o cualquier otro

síntoma, consulte al médico.

Contiene propilenglicol, puede producir síntomas parecidos a los del alcohol.

Contiene

Sulfito

sodioanhidro,

puede

causar

reacciones

alérgicas

graves

broncoespasmo.

Efectos indeseables:

Frecuentes: náuseas, vómitos, mareo, diarrea, dolor abdominal, prurito, e hipersensibilidad

(fiebre, erupción cutánea).

Ocasionales:

agranulocitosis,

discrasias

sanguíneas,

hepatitis

colestásica,

kernícterus

neonatos),

confusión

ancianos,

oliguria,

hematuria,

cristaluria,

urolitiasis,

oliguria,

fotosensibilidad, hiperkaliemia reversible.

Raras: reacciones de tipo anafilácticas en ocasiones fatales (Síndrome de Stevens-Johnson y

necrosis tubular renal, colitis pseudomembranosa, meningitis aséptica, artralgias, mialgias,

alteraciones de la función tiroidea, lupus eritematoso sistémico.

Posología y método de administración:

Antibacteriano (sistémico):

Adultos:

Infusión intravenosa, la dosis recomendada es en base a la trimetoprima es de 960 mg cada 12

horas.

En niños es de 36 mg/kg/día en 2 dosis divididas.

En el caso de neumonía por Pneumocystis carinii: La dosis por vía intravenosa se calcula de 20

mg y 100 mg de sulfametoxazol por kg/día (dividir en 2 o más subdosis) durante dos semanas.

Profilaxis de la neumonía por Pneumocystis carinii: en adultos 160 mg de trimetoprim y 800 mg

de sulfametoxazol 3 veces a la semana en días alternos.

La administración intravenosa se hace gota a gota durante, 60-90 minutos, evítese la infusión

rápida del medicamento o por bolo intravenoso.

Preparación de la solución inyectable:

Añadir a cada ampolleta de 5 mL, 125 mL de solución de dextrosa al 5 %. Después de

preparada la dilución utilícese dentro de las 6 horas siguientes. No la refrigere.

Cuando no sea aconsejable la administración de volúmenes grandes de solución, añada el

contenido de la ampolleta de 5 mL en 75 mL de solución de dextrosa al 5 %. Haga la mezcla y

utilícela antes de las dos horas siguientes.

Si la solución se enturbia o contiene evidencias de precipitación después de la mezcla

deséchela y prepare una nueva solución.

No incorpore a esta solución ningún medicamento ni la mezcle con ninguna otra solución.

Modo de administración: Intravenosa. No administrar sin dilución previa.

Interacción con otros productos medicinales y otras formas de interacción:

Incrementa

concentraciones

séricas

warfarina,

sulfonilureas,

difenilhidantoína,

procainamida y por tanto la ocurrencia de efectos adversos por estos fármacos.

En ancianos que han recibido como medicamento acompañante ciertos diuréticos, sobre todo

tiacidas parece incrementar el riesgo de agranulocitosis con o sin púrpura.

El uso junto a la amiodarona incrementa riesgo de ocurrencia de arritmias ventriculares.

La rifampicina disminuye el tiempo de vida media de trimetoprim.

El uso concomitante con zidovudina incrementa el riesgo de alteraciones hematológicas.

pacientes

trasplante

renal

consumen

ciclosporina,

administración

cotrimoxazol incrementa el riesgo de nefrotoxicidad (reversible).

El uso junto a pirimetamina, cuando esta se emplea a dosis mayores de 25 mg/d para la

profilaxis de la malaria, incrementa el riesgo de anemia megaloblástica (aumenta el efecto

antifolato).

Metotrexate, azatioprina y mercaptopurina incrementan el riesgo de toxicidad hematológica

cuando se administra clozapina junto a clotrimoxazol.

La metamina incrementa el riesgo de cristaluria.

Uso en Embarazo y lactancia:

Embarazo:

Categoría de riesgo C (en el primer trimestre el riesgo de teratogenicidad y en el tercero de

hemólisis neonatal y metahemoglubinemia). Debe ser administrado solamente si el beneficio

deseado justifica el riesgo potencial para el feto

Lactancia:

Es compatible aunque se debe evitar en menores de 6 semanas (excepto en caso de

tratamiento o profilaxis de neumonía por Pneumocistis carnii.

Efectos sobre la conducción de vehículos/maquinarias:

No procede.

Sobredosis:

Síntomas de sobredosificación aguda: náuseas, vómitos, obnubilación, cefalea, vértigo, estado

de confusión, anorexia, cólicos, pirexia, hematuria, cristaluria, depresión, discrasia sanguínea,

ictericia, trastornos psíquicos y visuales.

Síntomas en la sobredosificación crónica: depresión de la médula ósea con el cuadro de

fenómenos

trombocitopenia,

leucopenia,

anemia

megaloblásticas

otras

discrasias

sanguíneas. En estos casos se recomienda administrar de 5 a 15 mg al día de Leucoverín.

caso

sobredosificación

recomiendan

medidas

generales

apoyo:

Ventilación

adecuada y la administración de fluidos intravenosos, si la función renal es normal.

La acidificación de la orina acelera la excreción de la trimetoprima, la alcalinización y la diuresis

aceleran la excreción del sulfametoxazol.

Ambos son dializables.

Propiedades farmacodinámicas:

Mecanismo de acción:

El sulfametoxazol es un antiséptico bacteriostático de amplio espectro, siendo un inhibidor

competitivo de la utilización del ácido paraaminobenzoico (PABA), en la síntesis de dihidrofolato

por la célula bacteriana, lo que da lugar a un efecto bacteriostático.

La trimetoprima inhibe de manera reversible a la dihidrofolato reductasa (DHFR) bacteriana,

enzima que convierte el dihidrofolato en tetrahidrofolato. Dependiendo de las condiciones, el

efecto puede llegar a ser bactericida.

De este modo, la trimetoprima y el sulfametoxazol bloquean dos pasos consecutivos en la

biosíntesis del ácido fólico y por tanto, afecta profundamente la síntesis de las purinas, esencia-

les para la síntesis de los ácidos nucleicos de las bacterias. Esta acción produce una notable

potenciación de la actividad "in vitro" entre los dos agentes.

La mayoría de las bacterias patógenas comunes son sensibles "in vitro" a la trimetoprima y al

sulfametoxazol en concentraciones muy inferiores a las alcanzadas en la sangre, los líquidos

tisulares y la orina, después de la administración de la dosis recomendada. Las pruebas para

evaluar la sensibilidad de los microorganismos deberán realizarse en los medios de cultivo

recomendados, exentos de sustancias inhibidoras, en particular timidina y timina, con objeto de

obtener resultados confiables.

cotrimoxazol

frecuencia

eficaz

contra

microorganismos

resistentes

cualquiera de los dos componentes por separado.

Gracias al efecto doble del cotrimoxazol se reduce al mínimo el peligro de un amplio desarrollo

de resistencias. El efecto bactericida del cotrimoxazol "in vitro" se extiende a organismos

grampositivos y gramnegativos. En caso de infecciones provocadas en parte por gérmenes

sensibles se recomienda realizar un test de sensibilidad a fin de poder excluir una eventual

resistencia.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Absorción: Sulfametoxazol – 85 %

Trimetoprima > 95 %

Sus concentraciones séricas picos las alcanza entre 1-4 horas después de la administración

oral. La administración intravenosa alcanza concentraciones superiores.

Unión a proteínas:

Sulfametoxazol: De moderada a elevada (66 %).

Trimetoprima: De moderada a elevada (50 %).

Distribución: Se distribuye rápida y ampliamente en varios tejidos y líquidos, incluyendo riñones,

hígado, bazo, secreciones bronquiales, saliva y tejido y líquido prostático y también se ha

encontrado en el esputo y es las secreciones vaginales (hasta 3 veces las concentraciones

séricas usuales).

Trimetoprima:

La trimetoprima se ha encontrado en bilis, humor acuoso, médula ósea y hueso esponjoso, pero

no en el hueso compacto; mucosa intestinal, y líquido seminal. En estos fluidos y tejidos las

concentraciones son superiores a las plasmáticas.

Concentraciones en el líquido cefalorraquídeo (LCR): Del 30 al 50 % de las concentraciones

séricas.

En el humor acuoso, la leche materna, el LCR, el líquido del oído medio, el líquido sinovial y el

líquido intersticial, los niveles son adecuados para proporcionar actividad antibacteriana.

También atraviesa la placenta, al líquido amniótico y a los tejidos fetales donde alcanza

concentraciones que se aproximan a las del suero materno.

Trimetoprima: Es de 69 a 133 litros.

Sulfametoxazol: Es de 10 a 16 litros.

De 1,2 a 2 litros por kg.

En la edad infantil el volumen de distribución es 2 a 3 veces mayor.

Metabolismo:

Sulfametoxazol: Hepático: Por acetilación primaria a metabolitos inactivos, que retienen la

toxicidad

compuestos

principales.

Puede

ocurrir

conjugación

glucurónica

hígado.

Trimetoprima:

Hepático:

metaboliza

metabolitos

inactivos

O-desmetilación, N-oxidación del anillo, y alfa hidroxilación; los metabolitos pueden estar libres

o conjugados.

Vida media:

Sulfametoxazol:

Función renal normal: De 9 a 11 horas.

Estadio final de la insuficiencia renal: De 20 a 50 horas.

Trimetoprima:

Función renal normal: De 8,6 a 17 horas. Pacientes anúricos: Hasta 20 a 50 horas.

Cuando la depuración de creatinina es inferior a 10 mL/minuto, la vida media aumenta en un

factor de 1,5 a 3,0 por lo que deberá realizarse en estos casos un ajuste de dosis.

Tiempo hasta la concentración sérica media máxima:

Sulfametoxazol: De 2 a 4 horas (oral).

Trimetoprima: De 1 a 4 horas (oral).

Tiempo hasta la concentración máxima en sangre:

1 y 4 horas después de la administración y la concentración alcanzada está relacionada con la

dosis administrada. Las concentraciones sanguíneas eficaces persisten hasta por 24 horas des-

pués de administrar la dosis terapéutica. En el adulto, las concentraciones en estado de

equilibrio se obtienen después de la administración del fármaco durante 2 a 3 días. Ninguno de

los 2 componentes muestra algún efecto apreciable sobre la concentración alcanzada en la

sangre por el otro.

Tiempo hasta la concentración máxima en orina:

Sulfametoxazol: 0,5 horas.

Eliminación:

El aclaramiento renal es de 20 a 80 mL/min con la trimetoprima y de 1 a 5 mL/min con la

sulfametoxazol.

Trimetoprima:

Los metabolitos del sulfametoxazol carecen de actividad antibacteriana, los de la trimetoprima

poseen en parte actividad.

Sulfametoxazol:

Renal, por filtración glomerular, con alguna secreción tubular. La excreción aumenta en orina

alcalina; se excretan pequeñas cantidades en las heces, bilis, secreciones corporales y leche

materna. El 20 % se excreta de forma inalterada por la orina.

Diálisis: Se elimina de la sangre por hemodiálisis.

Renal, del 40 al 60 % se excreta en 24 horas, principalmente por filtración glomerular y

secreción tubular; un 80 a 90 % de esta cantidad se excreta inalterado y el resto se excreta

como metabolitos inactivos. La excreción aumenta en orina ácida y disminuye en orina alcalina.

Pequeñas cantidades se excretan en las heces (4 %, aproximadamente), bilis y leche materna.

Los metabolitos de la trimetoprima y el sulfametoxazol se con sideran formas terapéuticamente

activas.

diálisis:

trimetoprima

elimina

sangre

hemodiálisis

cantidades

significativas, requiriéndose, una dosis de mantenimiento máximo después del proceso de

diálisis. El proceso de diálisis peritoneal no es eficaz para eliminar la trimetoprima de la sangre

en caso de sobredosis.

El Sulfametoxazol se elimina de la sangre por hemodiálisis.

Debido a la excreción predominantemente renal, en pacientes encamados y en aquellos con

función renal insuficiente debe reducirse la dosificación. El tiempo se semi-eliminación de la

trimetoprima en niños es aproximadamente la mitad más breve en adultos, mientras que el de la

sulfametoxazol no se diferencia significativamente.

La concentración de sulfametoxazol activo en el líquido amniótico, el humor acuoso, la bilis, el

LCR, el líquido del oído medio, el esputo, el líquido sinovial y el líquido intersticial es del orden

del 20-50 % de la concentración plasmática correspondiente mientras que la de trimetroprima

es de 30-60%. Cuando la depuración de creatinina es inferior a 25 mL/minuto, ocurre una

prolongación de la vida media de los dos fármacos.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

No procede.

Fecha de aprobación/ revisión del texto: 30 de abril de 2017.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

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Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety