Vinorelbin Accord

Hauptinformation

  • Handelsname:
  • Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
  • Verschreibungstyp:
  • Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 137462
  • Berechtigungsdatum:
  • 02-03-2017
  • Letzte Änderung:
  • 02-12-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Gebrauchsinformation: Information für Anwender

Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Wirkstoff: Vinorelbin

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt, Apotheker oder das

medizinische Fachpersonal.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter.

Es kann anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie

Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich bitte an Ihren Arzt oder Apotheker.

Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

1. Was ist Vinorelbin Accord und wofür wird es angewendet?

2. Was sollten Sie vor der Anwendung von Vinorelbin Accord beachten?

3. Wie ist Vinorelbin Accord anzuwenden?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist Vinorelbin Accord aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1. Was ist Vinorelbin Accord und wofür wird es angewendet?

Vinorelbin Accord ist ein Konzentrat zur Herstellung einer Infusionslösung. Es enthält den

Wirkstoff Vinorelbin, der zur Gruppe der Zytostatika gehört. Diese Wirkstoffe beeinflussen das

Wachstum bösartiger Zellen.

Vinorelbin Accord wird zur Behandlung von Krebserkrankungen bei Erwachsenen eingesetzt,

insbesondere bei nicht kleinzelligem Lungenkrebs und Brustkrebs.

2. Was sollten Sie vor der Anwendung von Vinorelbin Accord beachten?

Vinorelbin Accord darf nicht angewendet werden,

wenn Sie allergisch gegen den Wirkstoff Vinorelbin oder gegen andere verwandte

Krebsmedikamente, die so genannten Vinca-Alkaloide, sind;

wenn Sie allergisch gegen einen der in Abschnitt 6 genannten sonstigen Bestandteile dieses

Arzneimittels sind;

wenn Sie schwanger sind oder glauben, möglicherweise schwanger zu sein;

wenn Sie stillen;

- bei einer verringerten Anzahl von weißen Blutkörperchen (Neutrophile) oder schweren

Infektionen (akut oder innerhalb der letzten 14 Tage);

- bei einer verringerten Anzahl an Blutplättchen;

- wenn Sie kürzlich gegen Gelbfieber geimpft wurden oder beabsichtigen, sich gegen

Gelbfieber impfen zu lassen.

Dieses Arzneimittel ist ausschließlich zur intravenösen Anwendung bestimmt und darf nicht in

die Wirbelsäule injiziert werden.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Vinorelbin Accord erhalten.

Informieren Sie Ihren Arzt,

wenn Sie einen Herzinfarkt in der Vorgeschichte haben oder schwere Brustschmerzen haben

wenn Sie eine Strahlentherapie erhalten und das Behandlungsfeld die Leber einschließt;

wenn Sie Anzeichen oder Symptome einer Infektion haben (z. B. Fieber, Schüttelfrost,

Husten);

wenn bei Ihnen eine Impfung geplant ist;

wenn Sie eine eingeschränkte Leberfunktion haben.

Vinorelbin Accord darf nicht mit den Augen in Kontakt kommen, da das Risiko

schwerwiegender Reizungen und Geschwürbildungen auf der Hornhaut (Kornea) besteht.

Wenn das Präparat in Kontakt mit den Augen gekommen ist, muss das Auge sofort mit

physiologischer Kochsalzlösung (0,9%iger Natriumchloridlösung) gespült und ein Augenarzt

aufgesucht werden.

Männer und Frauen, die mit Vinorelbin Accord behandelt werden, müssen vor und nach der

Behandlung eine zuverlässige Methode zur Empfängnisverhütung anwenden. Siehe auch unter

„Schwangerschaft, Stillzeit und Fortpflanzungsfähigkeit“. Sowohl Männer als auch Frauen

sollen sich die unten stehenden Informationen zu Schwangerschaft und Stillzeit durchlesen.

Vor jeder Verabreichung von Vinorelbin Accord werden Blutuntersuchungen durchgeführt.

Wenn die Ergebnisse dieser Untersuchung nicht zufrieden stellend sind, kann sich Ihre

Behandlung verzögern und weitere Untersuchungen durchgeführt werden, bis die Werte wieder

normal sind.

Anwendung von Vinorelbin Accord zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt, wenn Sie andere Arzneimittel einnehmen/anwenden, kürzlich andere

Arzneimittel eingenommen/angewendet haben oder beabsichtigen andere Arzneimittel

einzunehmen/anzuwenden.

Dies ist insbesondere wichtig, wenn es sich um eines der folgenden Arzneimittel handelt:

Arzneimittel zur Blutverdünnung (Antikoagulanzien)

ein zur Behandlung von Epilepsie angewendetes Arzneimittel namens Phenytoin

ein zur Behandlung von Pilzerkrankungen angewendetes Arzneimittel namens Itraconazol

ein Krebsmedikament namens Mitomycin C

Arzneimittel, die das Immunsystem beeinträchtigen, z. B. Ciclosporin und Tacrolimus

Lapatinib, ein Arzneimittel zur Behandlung von Krebs

Johanniskraut (Hypericum perforatum)

Antibiotika wie Rifampicin, Erythromycin, Clarithromycin, Telithromycin

antivirale Medikamente, die bei AIDS (HIV) eingesetzt werden, z. B. Ritonavir (HIV-

Protease-Inhibitoren)

Verapamil, Chinidin (zur Behandlung von Herzproblemen).

Von Impfungen (z. B. gegen Windpocken, Mumps, Masern etc.) wird während der Behandlung

mit Vinorelbin Accord abgeraten und der Gelbfieberimpfstoff darf währenddessen nicht

verabreicht werden, da das Risiko einer möglicherweise tödlich verlaufenden Impfkrankheit

besteht.

Bei gleichzeitiger Anwendung anderer Arzneimittel mit bekannter Knochenmarktoxizität

(Arzneimittel, die die roten und weißen Blutkörperchen sowie Blutplättchen beeinflussen) muss

mit verstärkten Nebenwirkungen gerechnet werden.

Anwendung von Vinorelbin Accord zusammen mit Nahrungsmitteln und Getränken

Es sind keine Wechselwirkungen bei der Anwendung von Vinorelbin Accord zusammen mit

Nahrungsmitteln und Getränken bekannt.

Anwendung bei Kindern und Jugendlichen

Die Sicherheit und Wirksamkeit bei Kindern ist nicht belegt.

Schwangerschaft, Stillzeit und Fortpflanzungsfähigkeit

Schwangerschaft

Sie dürfen Vinorelbin Accord nicht anwenden, wenn Sie schwanger sind oder glauben, dass

Sie schwanger sein könnten.

Wenn Sie eine Behandlung mit Vinorelbin benötigen, während Sie schwanger sind, oder wenn

während

Behandlung

Vinorelbin

Accord

schwanger

werden,

müssen

unverzüglich Ihren Arzt informieren.

Stillzeit

Sie dürfen Vinorelbin Accord nicht anwenden, wenn Sie stillen.

Wenn eine Behandlung mit Vinorelbin Accord erforderlich ist, muss abgestillt werden.

Fortpflanzungsfähigkeit

Männern, die mit Vinorelbin Accord behandelt werden, wird empfohlen, während der

Behandlung und bis zu 3 Monate nach deren Ende kein Kind zu zeugen und sich vor

Therapiebeginn über die Möglichkeit einer Spermienkonservierung beraten zu lassen, da

Vinorelbin Accord die Zeugungsfähigkeit beeinträchtigen kann.

Frauen in gebärfähigem Alter

Frauen im gebärfähigen Alter müssen während der Therapie mit Vinorelbin Accord und bis

3 Monate danach eine zuverlässige Methode zu Empfängnisverhütung anwenden und ihren Arzt

informieren, falls sie schwanger geworden sind.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Es wurden keine Untersuchungen zu den Auswirkungen von Vinorelbin auf die

Verkehrstüchtigkeit und die Fähigkeit zum Bedienen von Maschinen durchgeführt. Führen daher

kein Fahrzeug, wenn der Arzt Ihnen davon abgeraten hat oder Sie sich unwohl fühlen.

Achtung: Dieses Arzneimittel kann die Reaktionsfähigkeit und Verkehrstüchtigkeit

beeinträchtigen

3. Wie ist Vinorelbin Accord anzuwenden?

Wenden Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt an. Fragen Sie bei

Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht ganz sicher sind.

Dosierung

Vinorelbin Accord darf nur unter Aufsicht eines auf dem Gebiet der Onkologie erfahrenen Arztes

zubereitet und verabreicht werden.

Vor jeder Verabreichung wird Ihnen Blut abgenommen um festzustellen, ob Sie genügend

Blutzellen für die Behandlung mit Vinorelbin Accord haben. Wenn die Ergebnisse dieser Tests

nicht zufrieden stellend sind, kann sich Ihre Behandlung verzögern und es werden weitere

Untersuchungen durchgeführt, bis die Werte wieder normal sind.

Die übliche Dosis für Erwachsene beträgt 25-30 mg/m².

Verabreichungshäufigkeit

Vinorelbin Accord wird einmal wöchentlich verabreicht. Ihr Arzt wird die Behandlungsdauer

festlegen.

Befolgen Sie immer die Anweisungen des Arztes.

Dosisänderungen:

Im Falle einer schweren Leberfunktionsstörung kann die Dosis durch Ihren Arzt angepasst

werden. Bitte befolgen Sie die Anweisungen Ihres Arztes.

Im Falle einer Nierenfunktionsstörung ist eine Dosisanpassung nicht erforderlich. Bitte

befolgen Sie die Anweisungen Ihres Arztes.

Art der Anwendung

Vinorelbin Accord muss vor der Verabreichung verdünnt werden.

Vinorelbin Accord darf nur intravenös verabreicht werden. Es wird als Infusion über 6 bis

10 Minuten in eine Vene verabreicht.

Nach der Verabreichung wird die Vene gründlich mit einer sterilen Lösung gespült.

Wenn Sie eine größere Menge Vinorelbin Accord erhalten haben, als Sie sollten

Ihr Arzt wird dafür sorgen, dass die für Ihren Zustand richtige Dosis verabreicht wird.

Kontaktieren Sie Ihren Arzt, den Notdienst oder Ihren Apotheker, wenn Sie irgendwelche

Bedenken haben oder Symptome einer möglichen Überdosierung zeigen wie Fieber, Anzeichen

einer Infektion oder Verstopfung.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

4. Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Schwere Nebenwirkungen – wenn eine der folgenden Nebenwirkungen bei Ihnen auftritt,

kontaktieren Sie sofort einen Arzt:

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)

Schwere Infektionen mit Versagen mehrerer Organe oder Blutvergiftung. Kurzatmigkeit und

Verengung der Atemwege (Bronchospasmus).

Selten (kann bis zu 1 von 1.000 Behandelten betreffen)

Durch eine mangelnde Blutversorgung des Herzens verursachte Schmerzen in der Brust, die in

den Nacken oder Arm ausstrahlen können (Angina pectoris). Herzinfarkt (Myokardinfarkt).

Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

Ausgedehnte und sehr schwerwiegende allergische Reaktionen. Die Symptome können

plötzlichen keuchenden Atem, Anschwellen von Lippen, Zunge, Kehle oder Körper,

Schluckbeschwerden, Hautausschlag, Benommenheit, Ohnmacht (Anaphylaxie/anaphylaktischer

Schock/anaphylaktoide Reaktion) umfassen.

Dies sind sehr schwerwiegende Nebenwirkungen. Sie benötigen dringend ärztliche Hilfe.

Andere Nebenwirkungen – wenn Sie eine der folgenden Nebenwirkungen bemerken,

kontaktieren Sie so bald wie möglich Ihren Arzt:

Sehr häufig (kann mehr als 1 von 10 Behandelten betreffen)

Verminderte Anzahl weißer Blutkörperchen, was zu einem erhöhten Infektionsrisiko führen kann.

Verminderte Anzahl roter Blutkörperchen (Anämie), was zu Müdigkeit führen kann. Verlust der

tiefen Sehnenreflexe. Schwäche in den unteren Extremitäten. Entzündung im Mund oder der

Speiseröhre. Übelkeit und Erbrechen. Verstopfung. Abnorme Ergebnisse bei Leberfunktionstests.

Haarausfall. Hautrötung (Erythem), brennende Schmerzen, Verfärbung der Venen und/oder

Venenentzündung (lokale Phlebitis) an der Injektionsstelle.

Häufig (kann bis zu 1 von 10 Behandelten betreffen)

Infektionen (bakterielle, Viren- oder Pilzinfektionen) im Körper (Atemwege, Harntrakt, Magen-

Darm-Trakt und möglicherweise andere Organsysteme) mit Symptomen wie Fieber, Schmerzen

und Schüttelfrost. Niedrige Blutplättchenwerte (Blutungsrisiko). Durchfall. Muskel- und

Gelenkschmerzen einschließlich Kieferschmerzen. Veränderte Nierenfunktion (erhöhte

Kreatininwerte). Schwäche, Müdigkeit, Fieber, Schmerzen an verschiedenen Stellen.

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)

Starkes Taubheitsgefühl (Parästhesie). Niedriger Blutdruck, erhöhter Blutdruck, Hitzewallungen

und kalte Hände oder Füße.

Selten (kann bis zu 1 von 1.000 Behandelten betreffen)

Niedrige Natriumwerte im Blut (dies kann Symptome wie Müdigkeit, Verwirrung,

Muskelzuckungen und Koma verursachen). Veränderungen in der Aktivität des Herzens

(Veränderungen im EKG). Sehr niedriger Blutdruck oder Kollaps. Lungenerkrankung

(interstitielle Pneumopathie). Entzündung der Bauchspeicheldrüse. Paralytischer Darmverschluss

(Ileus). Hautreaktionen wie Hautausschlag, Juckreiz und Nesselsucht. Schädigung der Haut der

Injektionsstelle (Nekrose).

Sehr selten (kann bis zu 1 von 10.000 Behandelten betreffen)

Blutvergiftung, die lebensbedrohlich sein kann. Herzklopfen, beschleunigter Herzschlag,

Herzrhythmusstörungen.

Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

Generalisierte Infektion assoziiert mit einem Abfall der Anzahl weißer Blutkörperchen

(neutropene Sepsis). Abfall der Anzahl weißer Blutkörperchen mit Fieber (febrile Neutropenie).

Abnahme der Anzahl weißer und roter Blutkörperchen sowie Blutplättchen. Niedrige

Natriumwerte aufgrund einer Überproduktion eines zu Flüssigkeitsretention führenden Hormons,

was zu Schwäche, Müdigkeit oder Verwirrung führen kann (SIADH-Syndrom). Appetitverlust

(Anorexie). Hautrötung (Erythem) an Händen und Füßen.

Wie andere Vinca-Alkaloide ist Vinorelbin ein mäßig Blasen bildendes Mittel.

Veränderungen im Blut können ebenfalls auftreten. Ihr Arzt wird Bluttests veranlassen, um dies

zu beobachten (niedrige Anzahl weißer Blutkörperchen, Anämie und/oder niedrige Anzahl

Blutplättchen, Leberfunktion, Nierenfunktion und Veränderungen des Elektrolytgleichgewichts in

Ihrem Körper).

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt, Apotheker oder das

medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser

Packungsbeilage angegeben sind. Sie können Nebenwirkungen auch direkt über das

Bundesamt für Sicherheit im Gesundheitswesen,

Traisengasse 5,

1200 WIEN,

ÖSTERREICH

Fax: + 43 (0) 50 555 36207,

Website: http://www.basg.gv.at/

anzeigen. Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr

Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5. Wie ist Vinorelbin Accord aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton und der Durchstechflasche nach

„Verwendbar bis“ oder „Verw. bis“ angegebenen Verfalldatum nicht mehr anwenden. Das

Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

Im Kühlschrank aufbewahren (2 °C – 8 °C). Nicht einfrieren.

In der Originalverpackung aufbewahren, um den Inhalt vor Licht zu schützen.

Dauer der Haltbarkeit nach Verdünnung

Die chemische und physikalische Stabilität wurde für 24 Stunden bei 25 °C nachgewiesen.

Aus mikrobiologischer Sicht muss das Produkt sofort nach Verdünnung verbraucht werden,

sofern die Methode des Öffnens/Verdünnens nicht das Risiko einer mikrobiellen Kontamination

ausschließt.

Falls das Arzneimittel nicht unverzüglich verwendet wird, unterliegen Zeiten und Bedingungen

für die Aufbewahrung des angebrochenen Arzneimittels der Verantwortung des Anwenders.

Nicht einfrieren.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker,

wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen damit zum

Schutz der Umwelt bei.

6. Inhalt der Packung und weitere Informationen

Was Vinorelbin Accord enthält:

Der Wirkstoff ist Vinorelbin (als Tartrat). 1 ml Lösung enthält 10 mg Vinorelbin (als

Vinorelbintartrat).

Der sonstige Bestandteil ist Wasser für Injektionszwecke.

Jede Durchstechflasche mit 1 ml enthält 10 mg Vinorelbin (als Tartrat)

Jede Durchstechflasche mit 5 ml enthält 50 mg Vinorelbin (als Tartrat)

Wie Vinorelbin Accord aussieht und Inhalt der Packung

Klare, farblose bis hellgelbe Lösung. Vinorelbin Accord ist Durchstechflaschen aus Klarglas

(Typ I) mit Bromobutyl-Gummistopfen und blauem Aluminium-Flip-off-Verschluss erhältlich.

Packungsgrößen:

1 Durchstechflasche (1 Dosis) mit 1 ml

1 Durchstechflasche (1 Dosis) mit 5 ml

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex, HA1 4HF

Vereinigtes Königreich

Z.Nr.:

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR)

unter den folgenden Bezeichnungen zugelassen:

Name des

Mitgliedsstaates

Bezeichnung des Arzneimittels

Portugal

Vinorrelbina Accord

Österreich

Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Belgien

Vinorelbine Accord Healthcare 10 mg/ml, concentraat voor oplossing

voor intraveneuze infusie

Zypern

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

Tschechische Republik

Vinorelbine Accord 10 mg/ml koncentrát pro infuzní roztok

Dänemark

Vinorelbin Accord

Deutschland

Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Estland

Vinorelbine Accord

Spanien

Vinorelbine Accord 10 mg/ml concentrado para solución para

perfusión EFG

Finnland

Vinorelbine Accord 10 mg/ml nfuusiokonsentraatti, liuosta varten

Frankreich

Vinorelbine Accord 10 mg/ml solution à diluer pour perfusion

Diese Packungsbeilage wurde zuletzt überarbeitet im Oktober 2016.

Die folgenden Informationen sind für Ärzte bzw. medizinisches Fachpersonal bestimmt:

Vinorelbin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Hinweise zur Anwendung

ANTINEOPLASTISCHES MITTEL

Detaillierte Informationen zu diesem Arzneimittel finden Sie in der Zusammenfassung der

Merkmale des Arzneimittels.

Handhabung und Anwendung

Die Zubereitung und Verabreichung von injizierbaren Lösungen zytotoxischer Arzneimittel muss

durch speziell ausgebildetes Personal mit Kenntnis der verwendeten Arzneimittel erfolgen, unter

Bedingungen, die den Schutz der Umgebung und insbesondere den Schutz des damit befassten

Personals gewährleistet. Dies erfordert das Vorhandensein eines für diese Zwecke vorgesehenen

Arbeitsplatzes. Es ist verboten, in diesem Bereich zu rauchen, zu essen oder zu trinken.

Dem Personal muss geeignetes Arbeitsmaterial zur Verfügung gestellt werden, insbesondere

langärmelige Kittel, Schutzmasken, Kopfbedeckungen, Schutzbrillen, sterile Einmal-

Handschuhe, Schutzabdeckungen für den Arbeitsplatz und Sammelbehältnisse für Abfall.

Spritzen und Infusionssets müssen vorsichtig zusammengesetzt werden, um ein Auslaufen zu

vermeiden (die Verwendung eines Luer-Lock-Systems wird empfohlen).

Verschüttete oder ausgelaufene Flüssigkeit muss aufgewischt werden. Dabei sind

Schutzhandschuhe zu tragen.

Vorsichtsmaßnahmen müssen ergriffen werden, um eine Exposition des Personals in der

Schwangerschaft zu vermeiden.

Jeglicher Augenkontakt muss streng vermieden werden. Nach Augenkontakt ist sofort eine

gründliche Spülung mit physiologischer Kochsalzlösung vorzunehmen. Im Falle von Reizungen

muss ein Augenarzt aufgesucht werden.

Im Falle eines Hautkontaktes ist die betroffene Stelle sofort sorgfältig mit Wasser zu spülen.

Italien

Vinorelbina Accord

Lettland

Vinorelbine Accord 10 mg/ml koncentrāts infūziju šķīduma

pagatavošanai

Litauen

Vinorelbine Accord 10 mg/ml koncentratas infuziniam tirpalui

Malta

Vinorelbine 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni

Norwegen

Vinorelbine Accord 10 mg/ml, konsentrat til infusjonsvæske

Polen

Vinorelbine Accord

Rumänien

Vinorelbina Accord 10 mg/ml concentrat pentru soluţie perfuzabilă

Niederlande

Vinorelbine Accord 10 mg/ml concentraat voor oplossing voor infusie

Slowakei

Vinorelbine Accord 10 mg/ml infúzny koncentrát

Schweden

Vinorelbine Accord 10 mg/ml koncentrat till infusionsvätska, lösning

Slowenien

Vinorelbin Accord 10 mg/ml koncentrat za raztopino za infundiranje

Vereinigtes Königreich

Vinorelbine 10 mg/ml concentrate for solution for infusion

Nach Zubereitung der Lösung sind alle mit dem Arzneimittel in Berührung gekommenen

Oberflächen gründlich zu reinigen; Hände und Gesicht sind zu waschen.

Zubereitung der Infusionslösung

Es bestehen keine Inkompatibilitäten zwischen Vinorelbin Accord und Durchstechflaschen aus

Glas, PVC-Beuteln, Vinylacetat-Beuteln oder Spritzen aus Polypropylen.

Bei Behandlung mit einer Polychemotherapie darf Vinorelbin Accord nicht mit anderen

Substanzen gemischt werden.

Die intrathekale Verabreichung ist kontraindiziert.

Vinorelbin Accord darf nur intravenös als Infusion verabreicht werden.

Vinorelbin Accord kann als langsamer Bolus (6 – 10 min) nach Verdünnung in 20 – 50 ml

0,9%iger (9 mg/ml) Natriumchloridlösung oder 5%iger (50mg/ml) Glukoselösung oder als

Kurzinfusion (20 – 30 min) nach Verdünnung mit 125 ml 0,9%iger (9 mg/ml)

Natriumchloridlösung oder 5%iger (50 mg/ml) Glukoselösung gegeben werden. Im Anschluss an

die Gabe muss immer eine Infusion mit mindestens 250 ml isotonischer Natriumchloridlösung

durchgeführt werden, um die Vene zu spülen.

Vinorelbin darf nur intravenös verabreicht werden. Es ist sehr wichtig sicherzustellen, dass die

Kanüle sorgfältig in der Vene platziert ist, bevor die Infusion begonnen wird. Wenn Vinorelbin

während der intravenösen Infusion in das umgebende Gewebe austritt, kann es zu einer starken

Reizung kommen. In diesem Fall ist die Infusion zu unterbrechen, die Vene mit

Natriumchloridlösung zu spülen und die verbleibende Dosis über eine andere Vene zu

verabreichen. Im Falle einer Paravasation können Glucocorticoide intravenös gegeben werden,

um das Risiko einer Phlebitis zu verringern.

Exkremente und Erbrochenes müssen mit Vorsicht behandelt werden.

Aufbewahrung

Im Kühlschrank aufbewahren (2 °C – 8 °C). Nicht einfrieren.

In der Originalverpackung aufbewahren, um den Inhalt vor Licht zu schützen.

Dauer der Haltbarkeit nach Verdünnung

Die chemische und physikalische Stabilität wurde für 24 Stunden bei 25 °C nachgewiesen.

Aus mikrobiologischer Sicht muss das Produkt sofort nach Verdünnung verbraucht werden,

sofern die Methode des Öffnens/Verdünnens nicht das Risiko einer mikrobiellen Kontamination

ausschließt. Falls das Arzneimittel nicht unverzüglich verwendet wird, unterliegen Zeiten und

Bedingungen für die Aufbewahrung des angebrochenen Arzneimittels der Verantwortung des

Anwenders.

Nicht einfrieren.

Entsorgung

Nicht verwendetes Arzneimittel oder Abfallmaterial ist entsprechend den nationalen

Anforderungen zu beseitigen.

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

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