VINORELBINA ACCORD

Informazioni principali

  • Nome commerciale:
  • VINORELBINA ACCORD
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • VINORELBINA ACCORD
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Area terapeutica:
  • Vinorelbina
  • Dettagli prodotto:
  • 045113014 - " 10MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE " 1 FLACONCINO IN VETRO DA 1 ML - autorizzato; 045113026 - " 10MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE " 1 FLACONCINO IN VETRO DA 5 ML - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 045113
  • Ultimo aggiornamento:
  • 07-01-2019

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Foglio illustrativo: informazioni per l’utilizzatore

Vinorelbina Accord 10 mg/ml concentrato per soluzione per infusione

Medicinale equivalente

Legga attentamente questo foglio prima di usare questo medicinale, perché contiene

importanti informazioni per lei.

- Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.

- Se ha qualsiasi dubbio, si rivolga al medico, al farmacista o all’infermiere.

- Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad altre persone, anche se i sintomi

della malattia sono uguali ai suoi, perché potrebbe essere pericoloso.

- Se si manifesta un qualsiasi effetto indesiderato, si rivolga al medico o al farmacista. Vedere

paragrafo 4.

Contenuto di questo foglio:

1. Che cos’è Vinorelbina Accord e a cosa serve

2. Cosa deve sapere prima di usare Vinorelbina Accord

3. Come usare Vinorelbina Accord

4. Possibili effetti indesiderati

5. Come conservare Vinorelbina Accord

6. Contenuto della confezione e altre informazioni

1. Che cos’è Vinorelbina Accord e a cosa serve

Vinorelbina Accord è un concentrato per soluzione per infusione. Il principio attivo vinorelbina

appartiene ad un gruppo di agenti citostatici. Questi agenti interferiscono con la crescita delle

cellule maligne. Vinorelbina Accord è indicato nel trattamento dei tumori negli adulti, in particolare

nel carcinoma polmonare non a piccole cellule e nel cancro della mammella.

2. Cosa deve sapere prima di usare Vinorelbina Accord

Non usi Vinorelbina Accord

- se è allergico alla vinorelbina o ad uno qualsiasi dei medicinali appartenenti alla famiglia degli

alcaloidi della vinca;

- se è allergico ad uno qualsiasi degli altri componenti di Vinorelbina Accord (elencati al paragrafo

- se è in stato di gravidanza o pensa di poterlo essere;

- se sta allattando con latte materno;

- se ha un numero basso di globuli bianchi (neutrofili) o se ha o ha avuto recentemente (nelle

passate 2 settimane) una grave infezione;

- se ha un basso numero di piastrine;

- se sta per ricevere (o ha appena ricevuto) il vaccino della febbre gialla.

Questo medicinale è rigorosamente solo per uso endovenoso e non deve essere iniettato nella

colonna vertebrale.

Avvertenze e precauzioni

Si rivolga al medico o al farmacista prima di prendere Vinorelbina Accord.

Informi il medico:

- se ha un’anamnesi di attacchi cardiaci o forte dolore al petto;

- se è stato trattato con la radioterapia in una zona che comprenda il fegato;

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

- se ha sintomi di infezione (come febbre, brividi, tosse);

-se sta per ricevere un vaccino;

- se il suo fegato non funziona in modo normale.

- Vinorelbina Accord non deve entrare in contatto con gli occhi poiché vi è il rischio di grave

irritazione e persino di ulcere corneali. Se ciò si verifica, lavare immediatamente l'occhio con una

normale soluzione salina e contattare un oculista.

- Gli uomini e le donne che sono trattati con Vinorelbina Accord devono utilizzare un metodo

contraccettivo efficace durante e dopo il trattamento con vinorelbina; si prega di leggere il paragrafo

sulla gravidanza e l'allattamento. SIA gli uomini che le donne devono leggere le informazioni al

paragrafo “Gravidanza, allattamento e fertilità” che segue.

Prima di ogni somministrazione di Vinorelbina Accord, sarà prelevato un campione di sangue per

l’analisi dei suoi componenti. Se i risultati di queste analisi non sono soddisfacenti, il trattamento

può essere rinviato e saranno effettuati ulteriori controlli fino a quando questi valori non tornino alla

normalità.

Altri medicinali e Vinorelbina Accord

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere

qualsiasi altro medicinale.

Il medico dovrà prestare particolare attenzione se sta prendendo uno dei seguenti medicinali:

- medicinali per rendere il sangue più fluido (anticoagulanti)

- un medicinale antiepilettico chiamato fenitoina

- un medicinale antifungino chiamato itraconazolo

- un medicinale antitumorale chiamato mitomicina C

- medicinali che interferiscono con il sistema immunitario, come ciclosporina e tacrolimus

- utilizzo contemporaneo con lapatinib (medicinale utilizzato per trattare il cancro)

- erba di San Giovanni (Hypericum perforatum)

- antibiotici come la rifampicina, eritromicina, claritromicina, telitromicina

- medicinali antivirali utilizzati per l'AIDS (HIV) come ritonavir (inibitori della proteasi dell'HIV)

- verapamil, chinidina (usati per problemi cardiaci)

Vaccini (ad es. varicella, parotite, morbillo, ecc) e i vaccini per la febbre gialla non sono

raccomandati durante il trattamento con Vinorelbina Accord, poichè possono aumentare il rischio di

una malattia sistemica fatale.

L'uso di Vinorelbina Accord contemporaneamente ad altri medicinali con nota tossicità midollare

(che colpisce i globuli bianchi e rossi e le piastrine) può peggiorare alcuni effetti collaterali.

Vinorelbina Accord con cibo e bevande

Non ci sono interazioni con cibo e bevande durante il trattamento con Vinorelbina Accord.

Uso nei bambini e negli adolescenti

La sicurezza e l’efficacia nei bambini e negli adolescenti non sono state stabilite.

Gravidanza, allattamento e fertilità

Gravidanza

Non usi Vinorelbina Accord se è incinta o pensa di poterlo essere.

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Se ha iniziato il trattamento con Vinorelbina Accord ed è incinta o si verifica una gravidanza

durante il trattamento con Vinorelbina Accord, deve avvisare immediatamente il medico per

un consiglio.

Allattamento

Non assuma Vinorelbina Accord durante l’allattamento.

L’allattamento deve essere interrotto se è necessario il trattamento con Vinorelbina Accord.

Fertilità

Agli uomini trattati con Vinorelbina Accord va consigliato di non avere figli durante il trattamento e

per almeno 3 mesi dopo la fine del trattamento e di informarsi sulla possibilità di conservazione

dello sperma prima di iniziare il trattamento, poiché Vinorelbina Accord può alterare la fertilità

maschile.

Donne in età fertile

Le donne in età fertile devono essere avvertite di utilizzare un metodo contraccettivo efficace

durante il trattamento e nei tre mesi successivi e devono informare il proprio medico in caso di

gravidanza.

Guida di veicoli e utilizzo di macchinari

Non sono stati condotti studi sugli effetti di Vinorelbina Accord sulla capacità di guidare veicoli o di

utilizzare macchinari.

Pertanto, non guidi se il medico le ha raccomandato di non guidare o in caso

di malessere.

3. Come usare Vinorelbina Accord

Usi questo medicinale seguendo sempre esattamente le istruzioni del medico. Se ha dubbi consulti il

medico o il farmacista.

Dose

Vinorelbina Accord può essere preparato e somministrato solo da personale sanitario qualificato

specializzato in oncologia.

Prima di ogni somministrazione, deve essere prelevato un nuovo campione di sangue per il

controllo dei suoi componenti, in modo da verificare che il paziente abbia cellule nel sangue a

sufficienza per ricevere Vinorelbina Accord. Se i risultati di questi test non sono soddisfacenti, il

trattamento può essere rinviato e saranno condotti nuovi test fino a quando questi valori non

ritornino alla normalità.

La dose abituale per gli adulti è di 25-30 mg/m².

Frequenza di somministrazione

La somministrazione di Vinorelbina Accord è prevista una volta alla settimana. La frequenza sarà

determinata dal medico.

Seguire sempre le indicazioni del medico.

Aggiustamento della dose:

- In caso di significativa insufficienza epatica, la dose può essere aggiustata dal medico. È

necessario seguire le indicazioni del medico.

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

- In caso di insufficienza renale, non è necessario un aggiustamento della dose. È necessario seguire

le indicazioni del medico.

Modo e via di somministrazione

Vinorelbina Accord deve essere diluita prima della somministrazione

Vinorelbina Accord deve essere somministrata solo in vena. Le sarà somministrata mediante

infusione in vena. Saranno necessari dai 6 ai 10 minuti.

Dopo la somministrazione la vena deve essere lavata con una soluzione sterile.

Se prende più Vinorelbina Accord di quanto deve

Il medico deve sempre assicurarsi che lei riceva la dose adatta alla sua condizione. Tuttavia, contatti

il medico, il pronto soccorso o il farmacista se ha qualche sospetto o se ha sintomi di un potenziale

sovradosaggio, come febbre, segni di infezione o costipazione.

Se ha qualsiasi dubbio, si rivolga al medico o al farmacista.

4. Possibili effetti indesiderati

Come tutti i medicinali, questo medicinale può causare effetti indesiderati, sebbene non tutte le

persone li manifestino.

Effetti indesiderati gravi – se si manifesta uno dei seguenti effetti indesiderati informi

immediatamente il medico:

Non comune (può interessare fino a 1 persona su 100)

Infezioni gravi con insufficienza d’organo varia e avvelenamento del sangue. Respiro corto e

restringimento delle vie aeree (broncospasmo).

Raro (può interessare fino a 1 persona su 1.000)

Dolore al torace che può estendersi alla parte posteriore del collo e al braccio, dovuto alla mancanza

di afflusso di sangue al cuore (angina pectoris). Attacco cardiaco (infarto del miocardio).

Non nota (la frequenza non può essere definita sulla base dei dati disponibili)

Reazioni allergiche estese e molto gravi. I sintomi possono includere dispnea, gonfiore alle labbra,

lingua e gola o al corpo, difficoltà di deglutizione, eruzione cutanea, vertigini, svenimento

(anafilassi/shock anafilattico/reazione anafilattoide).

Questi effetti indesiderati sono molto gravi. Potrebbe aver bisogno di cure mediche urgenti.

Altri effetti indesiderati – se si manifesta uno dei seguenti effetti indesiderati informi

immediatamente il medico

Molto comune (può interessare più di 1 persona su 10)

Basso numero di globuli bianchi, che può aumentare il rischio di infezioni. Basso numero di globuli

rossi (anemia) che può farla sentire stanco. Perdita dei riflessi tendinei profondi. Debolezza degli

arti inferiori. Infiammazione della bocca o della gola. Nausea e vomito. Stipsi. Risultati anomali dei

test di funzionalità epatica. Caduta dei capelli.

Arrossamento (eritema), bruciore, scolorimento e/o

infiammazione delle vene (flebite locale) nel sito di iniezione.

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Comune (può interessare fino a 1 persona su 10)

Infezioni (batteriche, virali o fungine) nel corpo (sistema respiratorio, urinario, gastro-intestinali e

altri) con sintomi quali febbre, dolori e brividi. Basso numero di piastrine del sangue (rischio di

sanguinamento). Diarrea. Dolore nei muscoli e nelle articolazioni, incluso dolore alla mandibola.

Modifiche della funzionalità renale (aumento dei valori della creatinina). Debolezza, stanchezza,

febbre, dolore in diverse parti del corpo.

Non comune (può interessare fino a 1 persona su 100)

Intorpidimento grave (parestesia). Bassa pressione sanguigna, alta pressione sanguigna, vampate di

calore e sensazione di freddezza alle estremità.

Raro (può interessare fino a 1 persona su 1.000)

Bassi livelli di sodio nel sangue (che può causare sintomi di stanchezza, confusione, spasmi

muscolari e coma). Cambiamenti dell'attività cardiaca (modifiche dell’ECG). Grave abbassamento

della

pressione

sanguigna

collasso.

Patologia

polmonare

(pneumopatia

interstiziale).

Infiammazione del pancreas. Blocco intestinale paralitico (ileo). Reazioni cutanee come eruzioni,

prurito e orticaria. Necrosi al sito di iniezione.

Molto raro (può interessare fino a 1 persona su 10.000)

Avvelenamento del sangue che può causare pericolo di vita. Battito cardiaco forte, battito cardiaco

accelerato, disturbi del ritmo cardiaco.

Non nota (la frequenza non può essere definita sulla base dei dati disponibili)

Infezione generale in combinazione con un calo del numero di globuli bianchi (sepsi neutropenica).

Crollo del numero di globuli bianchi con febbre (neutropenia febbrile). Riduzione del numero di

globuli bianchi e rossi, così come delle piastrine. Bassi livelli di sodio a causa di una

sovrapproduzione di un ormone che causa ritenzione di liquidi e conseguente debolezza, stanchezza

o confusione (sindrome SIADH). Diminuzione dell'appetito (anoressia). Arrossamento (eritema)

delle mani e dei piedi.

Come con altri alcaloidi della vinca vinorelbina è un moderato agente vescicante.

Poiché si possono verificare cambiamenti nel sangue, il medico potrà richiedere il prelievo di

campioni di sangue per controllare (basso numero di globuli bianchi, anemia e/o basso numero di

piastrine nel sangue, l'influenza sulla funzione epatica o renale e l'equilibrio elettrolitico del suo

corpo).

Segnalazione degli effetti indesiderati

Se manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si

rivolga al medico o all’infermiere. Lei può inoltre segnalare gli effetti indesiderati direttamente

tramite il sistema nazionale di segnalazione all’indirizzo www.agenziafarmaco.gov.it/it/responsabili.

Segnalando gli effetti indesiderati lei può contribuire a fornire maggiori informazioni sulla

sicurezza di questo medicinale.

5. Come conservare Vinorelbina Accord

Conservi questo medicinale fuori dalla vista e dalla portata dei bambini.

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Non usi questo medicinale dopo la data di scadenza che è riportata sul flaconcino e sulla confezione

dopo SCAD. La data di scadenza si riferisce all’ultimo giorno di quel mese.

Conservare in frigorifero (2 °C – 8 °C). Non congelare.

Conservare nella confezione originale per proteggere il medicinale dalla luce.

Validità dopo diluizione

La stabilità chimica e fisica durante l'uso è stata dimostrata per 24 ore a 25° C.

Da un punto di vista microbiologico, a meno che il metodo di apertura/diluizione precluda il rischio

di contaminazione microbica, il prodotto deve essere utilizzato immediatamente dopo diluizione. Se

non viene utilizzato immediatamente, i tempi e le condizioni di conservazione sono responsabilità

dell'utilizzatore.

Non congelare.

Non getti alcun medicinale nelle acque di scarico o nei rifiuti domestici. Chieda al farmacista come

eliminare i medicinali che non utilizza più. Questo aiuterà a proteggere l’ambiente.

6. Contenuto della confezione e altre informazioni

Cosa contiene Vinorelbina Accord

Il principio attivo è la vinorelbina (come tartrato). 1 ml di soluzione contiene 10 mg di vinorelbina

(come vinorelbina tartrato).

L’altro componente è acqua per preparazioni iniettabili.

Ogni flaconcino da 1 ml contiene un totale di 10 mg di vinorelbina (come tartrato).

Ogni flaconcino da 5 ml contiene un totale di 50 mg di vinorelbina (come tartrato).

Descrizione dell’aspetto di Vinorelbina Accord e contenuto della confezione

Soluzione limpida, da incolore a giallo chiaro. Vinorelbina Accord è confezionata in flaconcini di

vetro trasparente di tipo I, con tappo

in gomma bromobutilica e sigillo di alluminio blu flip-off.

Vinorelbina Accord è disponibile in:

1 flaconcino da 1 ml

1 flaconcino da 5 ml

È possibile che non tutte le confezioni siano commercializzate.

Titolare dell’autorizzazione alla immissione in commercio e Produttore

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex,

HA1 4HF

Regno Unito

Questo foglio illustrativo è stato aggiornato il

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Questo medicinale è autorizzato negli Stati Membri della Spazio Economico Europeo con le

seguenti denominazioni:

Nome dello

Stato Membro

Nome del medicinale

Portogallo

Vinorrelbina Accord

Austria

Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Belgio

Vinorelbine Accord Healthcare 10 mg/ml, concentraat voor oplossing

voor intraveneuze infusie

Cipro

Vinorelbine Accord 10 mg/ml, concentrate for solution for infusion

Repubblica Ceca

Vinorelbine Accord 10 mg/ml koncentrát pro infuzní roztok

Danibarca

Vinorelbin Accord

Germania

Vinorelbine Accord 10 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Estonia

Vinorelbine Accord

Spagna

Vinorelbine Accord 10 mg/ml concentrado para solución para perfusión

Finlandia

Vinorelbine Accord 10 mg/ml nfuusiokonsentraatti, liuosta varten

Francia

Vinorelbine Accord 10 mg/ml solution à diluer pour perfusion

Italia

Vinorelbina Accord

Lettonia

Vinorelbine Accord 10 mg/ml koncentrāts infūziju šķīduma

pagatavošanai

Lituania

Vinorelbine Accord 10 mg/ml koncentratas infuziniam tirpalui

Malta

Vinorelbine 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni

Norvegia

Vinorelbine Accord 10 mg/ml, konsentrat til infusjonsvæske

Polonia

Vinorelbine Accord

Romania

Vinorelbina Accord 10 mg/ml concentrat pentru soluţie perfuzabilă

Paesi Bassi

Vinorelbine Accord 10 mg/ml concentraat voor oplossing voor infusie

Repubblica

Slovacca

Vinorelbine Accord 10 mg/ml infúzny koncentrát

Svezia

Vinorelbine Accord 10 mg/ml koncentrat till infusionsvätska, lösning

Slovenia

Vinorelbin Accord 10 mg/ml koncentrat za raztopino za infundiranje

Regno Unito

Vinorelbine 10 mg/ml concentrate for solution for infusion

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Le informazioni seguenti sono destinate esclusivamente ai medici e agli operatori sanitari:

Vinorelbina Accord 10 mg/ml concentrato per soluzione per infusione

Istruzioni per l'uso

AGENTE ANTINEOPLASTICO

Fare riferimento al Riassunto delle Caratteristiche del Prodotto per informazioni dettagliate riguardo

questo prodotto.

Manipolazione ed utilizzo

La preparazione e la somministrazione di soluzioni iniettabili di agenti citotossici deve essere

eseguita da personale specializzato qualificato con esperienza riguardo i farmaci utilizzati, in

condizioni che garantiscano la protezione dell'ambiente e, in particolare, la protezione del personale

addetto alla manipolazione dei farmaci. Si richiede un'area di preparazione riservata a questo scopo.

E' vietato fumare, mangiare o bere in quest’area.

Il personale deve essere rifornito di materiali appositi per la manipolazione, in particolare abiti con

maniche lunghe, maschere di protezione, cappellini, occhiali protettivi, guanti sterili monouso,

coperture di protezione per l'area di lavoro e sacchetti di raccolta per i rifiuti.

Le siringhe e i set di infusione devono essere assemblati con attenzione per evitare perdite (è

raccomandato l’uso di raccordi Luer lock).

Fuoriuscite e perdite devono essere pulite, indossando guanti di protezione.

Si devono prendere precauzioni per evitare l’esposizione del personale durante la gravidanza.

Va assolutamente evitato ogni contatto con gli occhi. Qualora questo si verificasse, lavare

immediatamente gli occhi con soluzione fisiologica normale. In caso di irritazione va contattato uno

specialista oftalmologo.

In caso di contatto con la pelle lavare accuratamente la zona interessata con acqua.

Alla fine, qualsiasi superficie esposta va pulita con cura, e le mani e la faccia lavate.

Preparazione della soluzione per infusione.

Non vi è alcuna incompatibilità di Vinorelbina Accord con flaconcini di vetro, sacca in PVC, sacca

di acetato di vinile o siringa in polipropilene.

In caso di polichemioterapia, Vinorelbina Accord non deve essere miscelata con altri agenti.

La somministrazione intratecale è controindicata.

Vinorelbina Accord deve essere somministrata come infusione solo per via endovenosa.

Vinorelbina Accord può essere somministrata in bolo lento (6-10 minuti) dopo diluizione in 20-50

ml di soluzione fisiologica normale o di soluzione di glucosio 50 mg/ml (5%) o per infusione di

breve durata (20-30 minuti) dopo diluizione in 125 ml di soluzione fisiologica normale o soluzione

di glucosio 50 mg/ml (5%). La somministrazione deve essere sempre seguita da un’infusione di

almeno 250 ml di soluzione isotonica per il lavaggio della vena.

Vinorelbina deve essere somministrata solo per via endovenosa. E’ molto importante assicurarsi,

prima di iniziare l’iniezione, che la cannula sia accuratamente posizionata nella vena. Se durante la

somministrazione endovenosa vinorelbina infiltra i tessuti circostanti, può verificarsi notevole

irritazione. In questo caso, l'iniezione deve essere arrestata, la vena lavata con soluzione salina e il

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

resto della dose somministrato in un'altra vena. In caso di stravaso, possono essere somministrati

glucocorticoidi per via endovenosa per ridurre il rischio di flebiti.

Escrementi e vomito devono essere maneggiati con cura.

Conservazione

Conservare in frigorifero (2 °C – 8 °C). Non congelare.

Conservare nella confezione originale per proteggere il medicinale dalla luce.

Validità dopo diluizione

La stabilità chimica e fisica durante l’uso è stata dimostrata per 24 ore a 25°C.

Dal punto di vista microbiologico, a meno che il metodo di apertura/diluizione precluda il rischio di

contaminazione microbica, il prodotto deve essere utilizzato immediatamente dopo diluizione. Se

non viene utilizzato immediatamente, i tempi e le condizioni di conservazione sono di

responsabilità dell'utilizzatore.

Non congelare.

Eliminazione

Il medicinale non utilizzati e i rifiuti derivati da tale medicinale devono essere smaltiti in conformità

alla normativa locale vigente.

Documento reso disponibile da AIFA il 14/09/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops

Modification of the existing maximum residue levels for spirotetramat in various crops

Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Publication of scientific data from EU-coordinated monitoring programmes and surveys

Published on: Thu, 17 Jan 2019 Open government data are about wide and free availability of public information created or collected by public entities. The International Open Data Charter and Findable, Accessible, Interoperable And Reusable Data (FAIR) data principles were selected as the guiding principles for the development of this report. A review of open data maturity reports indicated that most of the EU28+ are making significant progress in open government data, however there are different levels...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Genotoxicity assessment of chemical mixtures

Genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Guidance on Communication of Uncertainty in Scientific Assessments

Guidance on Communication of Uncertainty in Scientific Assessments

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Resapath

Resapath

The development of antimicrobial resistance in animal and human bacteria is a major public health issue requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to combat antimicrobial resistance, in particular by coordinating the French Surveillance Network for Antimicrobial Resistance in Pathogenic Bacteria of Animal Origin (Resapath), which is devoted to monitoring resistance in bact...

France - Agence Nationale du Médicament Vétérinaire

8-1-2019

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety