Oxaliplatin "Accord"

Primær information

  • Handelsnavn:
  • Oxaliplatin "Accord" 5 mg/ml koncentrat til infusionsvæske, opløsning
  • Dosering:
  • 5 mg/ml
  • Lægemiddelform:
  • koncentrat til infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Oxaliplatin "Accord" 5 mg/ml koncentrat til infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 44183
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel: sammensætning, indikationer, bivirkninger, dosering, interaktioner, bivirkninger, graviditet, amning

INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN

Oxaliplatin Accord 5 mg/ml, koncentrat til infusionsvæske, opløsning

Oxaliplatin

Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg lægen eller på apoteket, hvis der er mere, du vil vide.

Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt

her.

Denne indlægsseddel fortæller:

1. Oxaliplatin Accord virkning og hvad du skal bruge det til

2. Det skal du vide, før du begynder at bruge Oxaliplatin Accord

3. Sådan skal du bruge Oxaliplatin Accord

4. Bivirkninger

5. Opbevaring

6. Yderligere oplysninger

1. Oxaliplatin Accord virkning og hvad du skal bruge det til

Det aktive stof i Oxaliplatin Accord er oxaliplatin.

Oxaliplatin Accord bruges til behandling af kræft i tyktarmen (behandling af stadie III tyktarmskræft efter

komplet fjernelse af den primære kræftsvulst, metastatisk kræft i tyktarmen og endetarmen). Oxaliplatin

Accord bruges i kombination med anden anticancermedicin kaldet 5-fluorouracil og folininsyre.

Oxaliplatin Accord skal opløses, før det kan sprøjtes ind i en blodåre. Oxaliplatin Accord er et lægemiddel mod

kræft (antineoplastisk lægemiddel) og indeholder platin.

2. Det skal du vide, før du begynder at bruge Oxaliplatin Accord

Brug ikke Oxaliplatin Accord

- hvis du er overfølsom (allergisk) over for oxaliplatin eller et af de øvrige indholdsstoffer i Oxaliplatin Accord

inklusive lactosemonohydrat.

- hvis du har et nedsat antal blodceller.

- hvis du ammer.

- hvis du i forvejen har prikken og følelsesløshed i fingre og/eller tæer og har svært ved at udføre præcise

bevægelser såsom at knappe tøj.

- hvis du har alvorlige nyreproblemer.

Vær ekstra forsigtig med at bruge Oxaliplatin Accord

- hvis du har haft en allergisk reaktion over for platinholdige lægemidler såsom carboplatin eller cisplatin.

- hvis du har moderate nyreproblemer.

- hvis du har leverproblemer.

- hvis du er gravid eller planlægger at blive gravid er det meget vigtigt, at du drøfter dette med din læge, før du

modtager nogen form for behandling.

Oxaliplatin kan skade fertiliteten uopretteligt. Det frarådes derfor, at mandlige patienter bliver fader til et barn

under og op til seks måneder efter behandlingen, og de bør før behandlingen søge rådgivning om opbevaring af

sæd.

Brug af anden medicin

Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig. Dette gælder

også medicin, som ikke er købt på recept.

Graviditet og amning:

Graviditet

Du må ikke blive behandlet med oxaliplatin, medmindre sin læge mener, det er nødvendigt. Det frarådes, at du

bliver gravid under behandling med oxaliplatin, og du bør bruge sikker prævention. Hvis du bliver gravid under

behandlingen, skal du straks fortælle det til din læge. Sikker prævention skal anvendes under og efter afsluttet

behandling i henholdsvis 4 måneder for kvinder og 6 måneder for mænd.

Amning

Du må ikke amme, mens du behandles med oxaliplatin.

Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.

Trafik- og arbejdssikkerhed:

Behandling

oxaliplatin

medføre

øget

risiko

svimmelhed,

kvalme,

opkastning

andre

neurologiske symptomer, der påvirker gang og balance. Hvis du oplever disse symptomer, må du ikke køre bil

eller betjene maskiner. Hvis du får synsproblemer, når du tager Oxaliplatin Accord må du ikke køre bil eller

betjene maskiner eller udføre andre farlige aktiviteter.

3. Sådan skal du bruge Oxaliplatin Accord

Oxaliplatin Accord må kun anvendes til voksne.

Dosering

Din dosis af Oxaliplatin Accord er baseret på dit legemsoverfladeareal, der udregnes ud fra din vægt og højde.

Den sædvanlige dosis for voksne, inklusive ældre, er 85 mg per m

legemsoverflade. Dosen vil også afhænge af

resultaterne af blodprøver og af, om du tidligere har oplevet bivirkninger med Oxaliplatin Accord.

Dosering og indgivelsesmåde

Oxaliplatin Accord vil blive udskrevet til dig af en specialist i kræftbehandling.

Du vil blive behandlet af en læge, der vil fastsætte den påkrævede dosis Oxaliplatin Accord.

Oxaliplatin Accord gives som en langsom indsprøjtning i en vene (en intravenøs infusion) over en periode på

2 til 6 timer.

Oxaliplatin Accord vil blive givet samtidig med folininsyre og før infusionen af 5-fluorouracil.

Behandlingshyppighed

Du vil normalt modtage én infusion hver anden uge.

Behandlingens varighed

Behandlingens varighed vil blive bestemt af din læge.

Din behandling vil højst vare 6 måneder, når den finder sted efter fuldstændig fjernelse af din tumor.

Hvis du har taget for meget Oxaliplatin Accord

Kontakt lægen, skadestuen elleø apoteket, hvis De/du har taget mere af ” Oxaliplatin Accord”, end der står i

denne information, eller mere end lægen har foreskrevet (og du føler dig utilpas).

Da behandlingen med dette lægemiddel finder sted på et hospital, er det meget usandsynligt, at du vil få for

meget eller for lidt.

I tilfælde af overdosering kan du opleve forstærkede bivirkninger. Din læge vil afgøre, hvilken behandling du

skal modtage mod disse bivirkninger.

Spørg din læge, sygeplejerske eller på apoteket, hvis du vil vide mere om din behandling.

4. Bivirkninger

Oxaliplatin Accord kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Hvis du får bivirkninger, er det vigtigt, at du siger det til din læge inden næste behandling.

Nedenfor er beskrevet nogle af de bivirkninger, du kan opleve.

Sig det straks til din læge, hvis du oplever nogle af følgende bivirkninger:

Unormale blodudtrædninger, blødning eller tegn på infektion såsom ømhed i halsen eller høj temperatur.

Vedvarende eller alvorlig diarre eller opkastning.

- Tilstedeværelse af blod eller mørke, kaffefarvede korn i dit opkast.

Ømme læber eller sår i munden (stomatitis/mucositis).

Uventede åndedrætssymptomer såsom tør hoste, åndedrætsbesvær eller ændringer af din stemme.

En gruppe symptomer såsom hovedpine, ændret mental funktion, epilepsi og unormalt syn, fra sløret syn til

tab af syn (symptomer på såkaldt reversibelt posteriort leukoencefalopati-syndrom, en sjælden neurologisk

lidelse).

Andre kendte bivirkninger ved Oxaliplatin Accord er:

Meget almindelig (bivirkninger, der forekommer hos flere end 1 ud af 10 patienter):

Oxaliplatin Accord kan påvirke nerverne (perifer neuropati). Du kan føle prikken og/eller følelsesløshed i fingrene,

tæerne, omkring munden eller i halsen, som nogle gange kan optræde sammen med kramper.

Disse bivirkninger udløses ofte ved udsættelse for kulde, f.eks. åbning af et køleskab eller berøring af kolde

drikkevarer. Du kan også have svært ved at udføre præcise bevægelser, såsom at knappe tøj. Selv om disse

symptomer i de fleste tilfælde forsvinder fuldstændig, er der en mulighed for, at symptomer på svaghed

eller

følelsesløshed

pga.

nerveskader

(perifer

sensorisk

neuropati)

fortsætter

efter

afslutningen

behandlingen.

Nogle patienter har oplevet prikkende, chok-agtig følelse i arme eller overkrop, når nakken bøjes.

Oxaliplatin Accord kan nogle gange forårsage en ubehagelig følelse i halsen, særligt i forbindelse med

synkebevægelser, og give en følelse af stakåndethed. Hvis denne følelse optræder, er det som regel under

eller i timerne efter infusionen, og den kan udløses af udsættelse for kulde. Selv om følelsen er ubehagelig,

varer den ikke ved så længe og forsvinder, uden at der er behov for behandling. Din læge kan beslutte at

ændre din behandling som resultat af dette.

Oxaliplatin Accord kan forårsage diarré, mild kvalme og opkastning. Din læge vil dog sædvanligvis give

dig midler mod kvalme inden behandlingen, og i nogle tilfælde er det nødvendigt at fortsætte med at tage

dem efter behandlingen.

Oxaliplatin Accord forårsager et midlertidigt fald i antallet af blodceller. Faldet i antallet af røde blodceller kan

forårsage anæmi (mangel på røde blodceller), unormale blødninger eller blå mærker (på grund af det nedsatte antal

blodplader). Faldet i antallet af hvide blodceller kan gøre dig mere modtagelig over for infektioner. Din læge vil tage

blodprøver for at kontrollere, at du har tilstrækkeligt med blodceller, før du påbegynder behandlingen og før hver

behandlingsrunde.

Hypokaliæmi (for lavt indhold af kalium i blodet).

Hypernatriæmi (for meget natrium i blodet).

Træthed (fysisk og/eller psykisk udmattelse) og asteni (tab af eller mangel på kropsstyrke; svaghed).

Din læge vil tage blodprøver for at sikre, at du har tilstrækkeligt med blodceller, før behandlingen påbegyndes

og før hver behandlingsgang.

Følelse af ubehag tæt på eller på selve injektionsstedet under infusionen.

Feber, rysten (skælven), mild eller alvorlig træthed, kropssmerter.

Vægtændringer, tab af eller mangel på appetit, smagsforstyrrelser, forstoppelse.

Hovedpine, rygsmerter.

Hævede nerver, stivhed i hals/nakken, unormal tungefølelse, talebesvær, ømme læber eller sår i munden

(stomatitis/mucositis).

Mavesmerter.

Unormal blødning, inklusive næseblod.

Hoste, vejrtrækningsbesvær.

Allergiske reaktioner, hududslæt, som kan være rødt og kløende, mildt hårtab (alopeci).

Ændringer i blodprøveresultater, inklusive ændringer der vedrører leverfunktionen.

Almindelig (forekommer hos flere end 1 ud af 100, men hos færre end en ud af 10 patienter):

Infektioner som følge af nedsat antal hvide blodceller.

Fordøjelsesbesvær og halsbrand, hikke, rødmen, svimmelhed.

Øget svedtendens og neglelidelser, hudafskalning.

Brystsmerter.

Lungesygdomme og løbende næse.

Smerter i led og knogler.

Smerter ved vandladning og ændret nyrefunktion, ændringer i vandladningshyppighed, dehydrering.

Blod i urin/afføring, hævede vener, blodprop i lungerne.

Forhøjet blodtryk.

Depression og søvnløshed.

Konjunktivitis og synsproblemer.

Hyperhidrose (en lidelse kendetegnet ved øget svedafsondring)

Ikke almindelig (forekommer hos flere end 1 ud af 1.000, men hos færre end 1 ud af 100 patienter):

Forstoppelse eller hævelse af tarmene.

Nervøsitet.

Sjælden (forekommer hos flere end 1 ud af 10.000, men hos færre end 1 ud af 1.000 patienter):

Tab af hørelse.

Ardannelse på lungerne, der kan forårsage åndedrætsbesvær, nogle gange fatale (interstitial lungesygdom),

Forbigående synstab.

Meget sjælden (forekommer hos færre end 1 ud af 10.000 patienter):

Tilstedeværelse af blod eller mørke, kaffefarvede korn i dit opkast.

Ukendt (hyppigheden kan ikke anslås på grundlag af de foreliggende data)

Kramper.

Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.

Bivirkningerne kan dermed blive indberettet til Lægemiddelstyrelsen, og viden om bivirkninger kan blive

bedre. Patienter eller pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen. De/du finder

skema og vejledning under Bivirkninger på Lægemiddelstyrelsens netsted http://www.laegemiddelstyrelsen.dk/

5. Opbevaring

Opbevares utilgængeligt for børn.

Brug ikke Oxaliplatin Accord efter den udløbsdato, der står på pakningen. Udløbsdatoen henviser til den sidste

dag i den nævnte måned.

Hætteglasset skal opbevares i den ydre karton før blanding for at beskytte mod lys. Må ikke fryses.

Kemisk og fysisk brugsstabilitet påvist i op til 48 timer ved temperaturer på 2-8 ºC og i 24 timer ved +25 ºC.

Fra et mikrobiologisk og kemisk synspunkt bør infusionspræparatet anvendes straks. Hvis infusionspræparater

ikke anvendes med det samme, er opbevaringstid og øvrige forhold inden anvendelsen brugerens ansvar og må

normalt

ikke

overstige

timer

2-8°C,

medmindre

fortynding

foretaget

under

validerede

kontrollerede aseptiske forhold.

Brug ikke Oxaliplatin Accord hvis du bemærker, at opløsningen ikke er klar og fri for partikler.

Medicinen må ikke tilføres spildevand eller husholdningsaffald. Spørg dit apotek hvad du skal gøre ved

medicin, der ikke længere er nødvendig. Disse forholdsregler er med til at beskytte miljøet.

Oxaliplatin Accord må ikke komme i kontakt med øjne eller hud. Hvis der ved et uheld spildes lægemiddel,

skal du straks fortælle det til din læge eller sygeplejersken.

Når infusionen er afsluttet, vil lægen eller sygeplejersken bortskaffe tiloversbleven opløsning i

overensstemmelse med forskrifterne.

6. Yderligere oplysninger

Oxaliplatin Accord indeholder:

Oxaliplatin Accord indeholder det aktive stof oxaliplatin.

1 ml koncentrat til infusionsopløsning indeholder 5 mg oxaliplatin

10 ml koncentrat til infusionsopløsning indeholder 50 mg oxaliplatin.

20 ml koncentrat til infusionsopløsning indeholder 100 mg oxaliplatin.

40 ml koncentrat til infusionsopløsning indeholder 200 mg oxaliplatin.

De øvrige indholdsstoffer er laktosemonohydrat og vand til injektionsvæsker.

Udseende og pakningsstørrelser:

Oxaliplatin Accord er en klar farveløs opløsning uden synlige partikler.

Hvert hætteglas er pakket i en individuel karton.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen og fremstiller:

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow HA1 4HF, Storbritannien

Dette lægemiddel er godkent i EEA´s melemslande under følgende navne:

Medlemslandets navn

Lægemidlets navn

Storbritannien

Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

Østrig

Oxaliplatin Accord 5 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Belgien

Oxaliplatin

Accord

Healthcare

mg/ml

concentré

pour

solution

perfusion

concentraat

voor

oplossing

voor

infusie

Konzentrat

Herstellung einer Infusionslösung

Bulgarien

Оксалиплатин Акорд 5 mg/ml концентрат за инфузионен разтвор

Republikken Tjekkiet

Oxaliplatin Accord 5 mg/ml Koncentrát pro Přípravu Infuzního Roztoku

Tyskland

Oxaliplatin Accord 5 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Danmark

Oxaliplatin Accord 5 mg/ml koncentrat til infusionsvæske, opløsning.

Estland

Oxaliplatin Accord 5 mg/ml infusioonilahuse kontsentraat

Spanien

Oxaliplatino Accord 5 mg/ml Concentrado para Solución para Perfusión

Finland

Oxaliplatin Accord 5 mg/ml Infuusiokonsentraatti, Liuosta Varten/

koncentrat till infusionsvätska, lösning

Frankrig

Oxaliplatin Accord Healthcare 5 mg/ml concentré pour solution de

perfusion

Ungarn

Oxaliplatin Accord 5 mg/ml koncentrátum oldatos infúzióhoz

Irland

Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

Italien

Oxaliplatino Accord Healthcare 5 mg/ml Concentrato per soluzione per

infusione

Letland

Oxaliplatin Accord 5 mg/ml koncentrāts infūziju šķīduma pagatavošanai

Litauen

Oxaliplatin Accord 5mg/ml koncentratas infuziniam tirpalui

Malta

Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion

Formaterat: Svenska (Sverige)

Formaterat: Svenska (Sverige)

Holland

Oxaliplatin Accord 5 mg/ml concentraat voor oplossing voor infusie

Polen

Oxaliplatinum Accord, 5 mg/ml, koncentrat do sporządzania roztworu do

infuzji

Portugal

Oxaliplatina Accord

Rumænien

Oxaliplatin Accord 5 mg/ml concentrat pentru solutie perfuzabilà

Sverige

Oxaliplatin Accord 5 mg/ml Koncentrat till Infusionsvätska, Lösning

Denne indlægsseddel blev senest revideret 05/2012.

Følgende oplysninger er tiltænkt læger og sundhedspersonale

VEJLEDNING I PRÆPARERING AF OXALIPLATIN ACCORD

Det er vigtigt, at du læse hele denne procedurebeskrivelse før præparering af OXALIPLATIN ACCORD

1.

FORMULERING

Oxaliplatin Accord er en klar, farveløs opløsning, der indeholder 5 mg/ml oxaliplatin i lactosemonohydrat.

2.

PRÆSENTATION

Oxaliplatin Accord leveres i enkeltdosis-hætteglas. 1 hætteglas pr. karton.

10 ml:

Koncentrat til infusionsvæske, opløsning, er fyldt på klare, rørformede 10 ml type 1-hætteglas med 20 mm

chlorobutyl-gummiprop og forseglet med en lavendelblå 20 mm aluminium-hætte.

20 ml:

Koncentrat til infusionsvæske, opløsning, er fyldt på klare, støbte 20 ml type 1-hætteglas med 20 mm

chlorobutyl-gummiprop og forseglet med en lavendelblå 20 mm aluminium-hætte.

40 ml:

Koncentrat til infusionsvæske, opløsning, er fyldt på klare, støbte 50 ml type 1-hætteglas med 20 mm

chlorobutyl-gummiprop og forseglet med en lavendelblå 20 mm aluminium-hætte.

Opbevaringstid:

2 år

Efter fortynding i 5 % glucoseopløsning er kemisk og fysisk brugsstabilitet påvist i op til 48 timer ved

temperaturer på 2-8 ºC og i 24 timer ved +25 ºC.

mikrobiologisk

kemisk

synspunkt

bør

infusionspræparatet

anvendes

straks.

Hvis

infusionspræparater ikke anvendes med det samme, er opbevaringstid og øvrige forhold inden anvendelsen

brugerens ansvar og må normalt ikke overstige 24 timer ved 2-8°C, medmindre fortynding er foretaget under

validerede og kontrollerede aseptiske forhold.

Hætteglasset skal opbevares i den ydre karton før blanding for at beskytte mod lys. Må ikke fryses.

Inspicer opløsningen visuelt før anvendelse. Kun klare opløsninger uden partikler må anvendes.

Lægemidlet er udelukkende til engangsbrug. Eventuel tiloversbleven koncentrat bør bortskaffes.

3.

INSTRUKTIONER FOR SIKKER HÅNDTERING

Som med andre potentielt toksiske stoffer bør der udvises forsigtighed ved håndtering og præparering af

oxaliplatin-opløsninger.

Instruktioner for håndtering

Sundhedspersonalets

håndtering

dette

cytotoxiske

lægemiddel

kræver

omfattende

sikkerhedsforanstaltninger for at beskytte personalet, som håndterer lægemidlet, samt det omgivende miljø.

Præparering af injicerbare cytotoksiske opløsninger skal foretages af erfarent, specialiseret personale med

viden om disse lægemidler og under forhold, som garanterer integriteten af produktet, beskyttelse af miljø

især

beskyttelse

personale,

håndterer

lægemidlet,

overensstemmelse

hospitalets

procedurer. Tilberedning bør ske i et særligt område udelukkende til dette formål. Rygning, indtagelse af

mad og drikke er ikke tilladt i dette område.

Personalet

skal

forsynes

specielt

beskyttelsesudstyr

såsom

langærmede

beskyttelsesdragter,

beskyttelsesmasker,

hovedbeklædning,

beskyttelsesbriller,

sterile

engangshandsker,

beskyttelsesdug

tilberedningsområdet samt containere og beholdere til affald.

Sekreter og opkast bør håndteres med forsigtighed.

Gravide kvinder bør advares imod at håndtere cytotoksiske stoffer.

Eventuelle ituslåede beholdere skal behandles med samme forsigtighed og betragtes som kontamineret

affald. Kontamineret affald bør destrueres i særskilte, stive, mærkede beholdere. Se nedenstående afsnit

“Destruktion”.

Hvis Oxaliplatin Accord kommer i kontakt med huden, vask da øjeblikkeligt huden grundigt med vand.

Hvis Oxaliplatin Accord kommer i kontakt med slimhinder, vask da øjeblikkeligt grundigt med vand.

4.

PRÆPARERING TIL INTRAVENØS ADMINISTRATION

Særlige forholdsregler ved administration

Anvend IKKE injektionsudstyr indeholdende aluminium.

Må IKKE anvendes ufortyndet.

Kun 5% glucose-infusionsopløsning må anvendes til fortynding. Opløs eller fortynd IKKE til infusion

med natriumchlorid eller opløsninger indeholdende chlorid.

Bland IKKE med andre lægemidler i samme infusionspose og administrer IKKE i den samme

infusionslinie.

Bland

IKKE

alkaliske

lægemidler

eller

opløsninger,

specielt

5-fluorouracil-/folininsyre-

præparater

indeholdende

trometamol

hjælpestof

samt

trometamol-salte

andre

aktive

substanser.

Alkaliske

lægemidler

eller

opløsninger

ugunstig

måde

påvirke

stabiliteten

oxaliplatin.

Instruktioner for anvendelse med folininsyre (som calciumfolat eller dinatriumfolat)

Oxaliplatin 85 mg/m

intravenøs infusion i 250-500 ml 5% glucoseopløsning gives samtidig med folininsyre

intravenøs infusion i 5% glucoseopløsning over 2-6 timer ved anvendelse af en Y-linie placeret umiddelbart

før infusionsstedet.

Disse to lægemidler bør ikke blandes i samme infusionspose. Folininsyren må ikke indeholde trometamol

som hjælpestof og må kun fortyndes med en isotonisk 5% glucoseopløsning, aldrig i basiske opløsninger

eller natriumchlorid eller opløsninger indeholdende chlorid.

Instruktioner for anvendelse med 5-fluorouracil

Oxaliplatin bør altid administreres før fluoropyrimidiner – dvs. 5-fluoroucacil.

Efter administration med Oxaliplatin skal infusionslinien skylles, hvorefter 5-fluorouracil administreres.

For yderligere information om lægemidler i kombination med oxaliplatin, se fremstillerens respektive

produktresumé.

- Brug KUN de anbefalede solvenser (se nedenfor).

4.1

Præparering af infusionsopløsningen

Udtag den nødvendige mængde koncentrat fra hætteglasset/hætteglassene og fortynd herefter med 250-500

glucoseopløsning

oxaliplatin-koncentration

mellem

mg/ml

mg/ml,

koncentrationsområde, i hvilket fysisk-kemisk stabilitet for oxaliplatin er påvist.

Administrer ved intravenøs infusion.

Efter fortynding i 5 % glucoseopløsning er kemisk og fysisk brugsstabilitet påvist i op til 48 timer ved

temperaturer på 2-8 ºC og i 24 timer ved +25 ºC.

mikrobiologisk

kemisk

synspunkt

bør

infusionspræparatet

anvendes

straks.

Hvis

infusionspræparater ikke anvendes med det samme, er opbevaringstid og øvrige forhold inden anvendelsen

brugerens ansvar og må normalt ikke overstige 24 timer ved 2-8°C, medmindre fortynding er foretaget

under validerede og kontrollerede aseptiske forhold.

Inspicer opløsningen visuelt før anvendelse. Kun klare opløsninger uden partikler bør anvendes.

Lægemidlet er udelukkende til engangsbrug. Eventuel tiloversbleven koncentrat bør bortskaffes

Brug ALDRIG natriumchloridopløsning eller opløsninger indeholdende chlorid til fortynding.

Oxaliplatin-infusionsvæske

blevet

testet

uforligelighed

repræsentative,

PVC-baserede

infusionssæt.

Administrationen af Oxaliplatin kræver ikke præhydrering.

4.2

Infusion af opløsningen

Administrationen af Oxaliplatin kræver ikke præhydrering.

Oxaliplatin fortyndet i 250-500 ml 5% glucoseopløsning til en koncentration på mindst 0,2 mg/ml skal

infunderes via en perifer vene eller en central venøs line over 2-6 timer. Når oxaliplatin administreres med

5-fluorouracil, skal infusionen med oxaliplatin foretages inden administration af 5-fluorouracil.

4.3

Destruktion

Såvel resterende lægemiddel som alle materialer, som har været anvendt ved rekonstituering, fortynding og

administration, skal destrueres i henhold til hospitalets gældende procedurer for cytotoksisk affald og under

hensyntagen til lokale regler for bortskaffelse af farligt affald.

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

29-8-2018

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

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

Published on: Tue, 28 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 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 prochloraz. To assess the occurrence of prochloraz 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 as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 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 levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 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

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

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

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety