Docetaxel Accord

Primær information

  • Handelsnavn:
  • Docetaxel Accord
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Docetaxel Accord
    Den Europæiske Union
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Antineoplastiske midler
  • Terapeutisk område:
  • Carcinom, ikke-småcellet lunge
  • Terapeutiske indikationer:
  • Brystkræft.

Andre oplysninger

Status

  • Kilde:
  • EMA - European Medicines Agency
  • Autorisation status:
  • autoriseret
  • Autorisationsnummer:
  • EMEA/H/C/002539
  • Autorisation dato:
  • 22-05-2012
  • EMEA kode:
  • EMEA/H/C/002539
  • Sidste ændring:
  • 27-02-2018

Offentlige vurderingsrapport

+44 (0)20 7418 8416

© European Medicines Agency, 2012. Gengivelse af indholdet heri er tilladt med kildeangivelse.

EMEA/H/C/002539

EPAR sammendrag for offentligheden

Docetaxel Accord

docetaxel

Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docetaxel Accord.

Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede

frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om

anvendelsesbetingelserne for Docetaxel Accord.

Hvad er Docetaxel Accord?

Docetaxel Accord er et lægemiddel, der indeholder det aktive stof docetaxel. Det leveres som et

koncentrat, der efter fortynding indgives ved infusion (med drop i en vene).

Docetaxel Accord er et ‘generisk lægemiddel’. Det betyder, at Docetaxel Accord er identisk med et

‘referencelægemiddel’, som allerede er godkendt i Den Europæiske Union (EU) kaldet Taxotere. De

nærmere oplysninger om generiske lægemidler findes i dokumentet med spørgsmål og svar her

Hvad anvendes Docetaxel Accord til?

Docetaxel Accord anvendes til behandling af følgende kræfttyper:

brystkræft. Docetaxel Accord kan anvendes som eneste behandling, når andre lægemidler har

været uden virkning. Alt efter brystkræftens type og stadium kan det også bruges sammen med

andre kræftmidler (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) til patienter, der

endnu ikke har fået nogen medicin mod deres kræft, eller hos hvem andre midler har været uden

virkning.

ikke-småcellet lungekræft. Docetaxel Accord kan anvendes som eneste behandling, når andre

lægemidler har været uden virkning. Det kan også bruges sammen med cisplatin (et andet

kræftmiddel) til patienter, der endnu ikke har fået nogen medicin mod deres kræftsygdom.

prostatakræft, når hormonbehandling ikke virker på sygdommen. Docetaxel Accord anvendes

sammen med prednison eller prednisolon (antiinflammatoriske lægemidler).

kirtelkræft i maven hos patienter, der endnu ikke har fået nogen medicin mod deres kræft.

Docetaxel Accord anvendes sammen med cisplatin og 5-fluoruracil (andre lægemidler mod kræft).

kræft i hoved- og halsregionen, når sygdommen er lokalt fremskreden (kræft, der er vokset, men

ikke har bredt sig). Docetaxel Accord anvendes sammen med cisplatin og 5-fluoruracil.

De fuldstændige oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.

Lægemidlet udleveres kun efter recept.

Hvordan anvendes Docetaxel Accord?

Behandling med Docetaxel Accord bør kun finde sted på en specialafdeling for kemoterapi (lægemidler

mod kræft) under overvågning af en læge med speciale i kemoterapi.

Docetaxel Accord gives hver tredje uge ved en infusion, der varer en time. Dosis, behandlingsvarighed

og kombination med andre lægemidler afhænger af den behandlede kræfttype. Docetaxel Accord må

kun bruges, når neutrofiltallet (antallet af en type hvide blodlegemer) er normalt (mindst 1 500

celler/mm

). Der bør desuden gives et antiinflammatorisk lægemiddel såsom dexamethason,

begyndende dagen før infusionen med Docetaxel Accord. Yderligere oplysninger fremgår af

produktresuméet.

Hvordan virker Docetaxel Accord?

Det aktive stof i Docetaxel Accord, docetaxel, tilhører en gruppe lægemidler mod kræft, der kaldes

taxaner. Docetaxel blokerer cellens evne til at nedbryde det indvendige celleskelet. Det er denne evne,

der gør det muligt for cellerne at dele og formere sig. Når celleskelettet hele tiden er intakt, kan

cellerne ikke dele sig og vil til sidst dø. Docetaxel påvirker også andre celler end kræftcellerne, således

blodcellerne. Dette kan give bivirkninger.

Hvordan blev Docetaxel Accord undersøgt?

Virksomheden fremlagde oplysninger fra den publicerede litteratur om docetaxel. Virksomheden

påviste derudover, at infusionsopløsningen Docetaxel Accord har samme kvalitet som Taxotere. Der er

ikke brug for yderligere undersøgelser, da Docetaxel Accord er et generisk lægemiddel, der gives ved

infusion og indeholder samme aktive stof som referencelægemidlet Taxotere.

Hvilke fordele og risici er der forbundet med Docetaxel Accord?

Da Docetaxel Accord er et generisk lægemiddel, antages det at have de samme fordele og risici som

referencelægemidlet.

Hvorfor blev Docetaxel Accord godkendt?

CHMP konkluderede, at Docetaxel Accord er påvist at svare til Taxotere i overensstemmelse med EU-

reglerne. CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Taxotere. Udvalget

anbefalede udstedelse af markedsføringstilladelse for Docetaxel Accord.

Andre oplysninger om Docetaxel Accord

Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske

Union for Docetaxel Accord den 22. maj 2012.

Docetaxel Accord

EMA/227564/2012

Side 2/3

Docetaxel Accord

EMA/227564/2012

Side 3/3

Den fuldstændige EPAR for Docetaxel Accord findes på agenturets websted: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. Hvis du ønsker yderligere

oplysninger om behandling med Docetaxel Accord, kan du læse indlægssedlen (også en del af denne

EPAR) eller kontakte din læge eller dit apotek.

Den fuldstændige EPAR for referencelægemidlet findes ligeledes på agenturets websted.

Dette sammendrag blev sidst ajourført i 04-2012.

Indlægsseddel

B. INDLÆGSSEDDEL

Indlægseddel: Information til brugeren

Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning

Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning

Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning

docetaxel

Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den

indeholder vigtige oplysninger.

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

Spørg lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis der er mere, du vil vide.

Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,

eller du får bivirkninger, som ikke er nævnt her. Se punkt 4.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide, før du begynder at bruge Docetaxel Accord

Sådan skal du bruge Docetaxel Accord

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Medicinen hedder Docetaxel Accord. Det er et handelsnavn for docetaxel. Docetaxel er et stof, der

udvindes af nålene fra takstræer.

Docetaxel hører til gruppen af kræftmedicin, der kaldes taxoider.

Docetaxel Accord er ordineret af din læge til behandling af bryst- eller specielle former for lungekræft

(ikke-småcellet lungekræft), prostata kræft, gastrisk kræft eller hoved- og hals-kræft:

Ved behandling af fremskreden brystkræft kan docetaxel enten indgives alene eller i kombination

med doxorubicin, eller trastuzumab eller capecitabin.

Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder, kan docetaxel

anvendes i kombination med doxorubicin eller cyclophosphamid.

Ved behandling af lungekræft kan docetaxel enten indgives alene eller i kombination med

cisplatin.

Ved behandling af prostatakræft kan docetaxel indgives i kombination med prednison eller

prednisolon.

Ved behandling af metastatisk gastrisk kræft indgives docetaxel i kombination med cisplatin og 5-

fluoruracil.

Til behandling af hoved- og hals-kræft indgives docetaxel i kombination med cisplatin og 5-

fluoruracil.

2.

Det skal du vide, før du begynder at bruge Docetaxel Accord

Brug ikke Docetaxel Accord

hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i

Docetaxel Accord,

hvis antallet af hvide blodlegemer er for lavt,

hvis du har en alvorlig leverlidelse.

Advarsler og forsigtighedsregler

Før hver behandling med Docetaxel Accord, vil du få taget blodprøver for at få kontrolleret, om du har

nok blodceller og den nødvendige leverfunktion til at få Docetaxel Accord. I tilfælde af forstyrrelser af

de hvide blodlegemer kan du få feber eller infektioner.

Kontakt lægen, hospitalsfarmaceuten elle sundhedspersonalet, hvis du oplever problemer med dit syn.

Hvis du får problemer med synet, særligt sløret syn, skal du straks have undersøgt dine øjne og dit syn.

Kontakt lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du har haft en allergisk reaktion

ved tidligere behandling med paclitaxel.

Kontakt lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du har hjerteproblemer.

Hvis du udvikler akutte problemer med lungerne (feber, åndenød eller hoste), eller de bliver værre,

skal du straks fortælle det til lægen eller sundhedspersonalet. Lægen vil måske stoppe din behandling

med det samme.

Du vil blive bedt om at tage præmedicin bestående af oralt kortikosteroid såsom dexamethason 1 dag

før Docetaxel Accord-behandlingen. Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage

for at formindske visse bivirkninger, som kan forekomme efter infusionen af Docetaxel Accord.

Specielt kan der være tale om bivirkninger som allergiske reaktioner og væskeansamlinger (hævede

hænder, fødder, ben eller vægtøgning).

Under behandlingen kan du få anden medicin til at opretholde antallet af blodcellerne.

Docetaxel Accord indeholder alkohol. Tal med din læge, hvis du lider af alkohol afhængighed,

epilepsi eller sygdomme i leveren. Se også punktet ”Docetaxel Accord indeholder ætanol (alkohol)”

nedenfor.

Brug af anden medicin sammen med Docetaxel Accord

Informer din læge eller hospitalsfarmaceut, hvis du tager eller for nylig har taget nogen anden form for

medicin, herunder også medicin, som ikke er på recept. Dette er fordi Docetaxel Accord eller den

anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.

Mængden af alkohol i dette lægemiddel kan ændre virkningen af anden medicin.

Graviditet, amning og frugtbarhed

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

Docetaxel Accord må IKKE

anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre

din læge udtrykkelig ønsker det.

Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv

prævention under behandlingen, fordi docetaxel kan skade det ufødte barn. Hvis du bliver gravid

under behandlingen, skal du straks fortælle det til din læge.

Hvis du er mand og i behandling med docetaxel, rådes du til ikke at avle et barn under og 6 måneder

efter behandling samt til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel

kan nedsætte den mandlige fertilitet.

Amning:

Du må IKKE amme, mens du behandles med docetaxel.

Trafik- og arbejdssikkerhed:

Den mængde alkohol, som dette lægemiddel indeholder, kan nedsætte din evne til at køre bil eller

betjene maskiner.

Docetaxel Accord indeholder ætanol (alkohol)

Docetaxel Accord 20 mg/1 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 395 mg

vandfri ætanol pr. hætteglas, svarende til 10 ml øl eller 4 ml vin.

Docetaxel Accord 80 mg/4 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 1,58 g vandfri

ætanol pr. hætteglas, svarende til 40 ml øl eller 17 ml vin.

Docetaxel Accord 160 mg/8 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 3,16 g

vandfri ætanol pr. hætteglas, svarende til 80 ml øl eller 33 ml vin.

Kan være skadeligt for alkoholikere.

Dette skal tages i betragtning hos gravide eller ammende, hos børn samt hos patienter i

højrisikogrupper såsom patienter med leversygdomme samt epilepsi.

Mængden af alkohol i dette lægemiddel kan påvirke centralnervesystemet (den del af nervesystemet,

der omfatter hjernen og rygmarven).

3.

Sådan skal du bruge Docetaxel Accord

Docetaxel Accord vil blive administreret af personale med en sundhedsfaglig uddannelse.

Anbefalet dosis

Dosis vil afhænge af din vægt og din almene tilstand. Din læge vil beregne din legemsoverflade i m

og bestemme den dosis, du skal have.

Metode og måden at give medicinen på

Docetaxel Accord gives som infusion i en blodåre (intravenøs anvendelse). Infusionen tager ca. en

time, mens du er på hospitalet.

Hvor ofte gives medicinen

Du vil normalt få en infusion en gang hver 3. uge.

Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene

helbredstilstand og din reaktion på Docetaxel Accord. Vær særlig opmærksom på at informere din

læge, hvis du får diarré, sår i munden, følelsesløshed, stikkende og prikkende fornemmelser eller

feber, og giv lægen resultatet af dine blodprøver. Denne information vil give lægen mulighed for at

vurdere om en nedsættelse af dosis er nødvendig. Hvis du har yderligere spørgsmål om anvendelsen af

dette lægemiddel, så spørg din læge eller hospitalsfarmaceut.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Din læge vil diskutere disse med dig og forklare fordele og mulige risici ved behandlingen.

De mest almindelige bivirkninger af docetaxel givet alene er: Fald i antallet af røde og hvide

blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.

Alvorligheden af bivirkningerne ved docetaxel kan forøges, når docetaxel gives i kombination med

andre kemoterapeutiske lægemidler.

Følgende allergiske reaktioner (kan forekomme hos flere end 1 ud af 10 patienter) kan optræde under

infusionen på hospitalet:

Rødme i ansigtet, hudreaktioner, kløe

trykken for brystet, besvær med at trække vejret

feber eller kulderystelser

rygsmerter

lavt blodtryk

Mere alvorlige reaktioner kan forekomme.

Hvis du har haft en allergisk reaktion over for paclitaxel, kan du også få en allergisk reaktion over for

docetaxel, som kan være mere alvorlig.

Din tilstand vil blive nøje kontrolleret af hospitalspersonalet under behandlingen. Hvis du får nogle af

disse bivirkninger, så fortæl det straks til lægen.

Følgende kan ske mellem docetaxel-infusionerne. Hyppigheden kan variere alt efter kombinationen af

de lægemidler, du får.

Meget almindelige

(kan forekomme hos flere end 1 ud af 10 patienter):

Infektioner, fald i antallet af røde blodlegemer (anæmi), eller hvide blodlegemer (som er vigtige

for at bekæmpe infektioner) og blodplader

Feber: Hvis dette forekommer, skal du straks fortælle det til din læge

Allergiske reaktioner som beskrevet ovenfor

Tab af appetit (anoreksi)

Søvnløshed

Følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i muskelfæster

Hovedpine

Smagsforstyrrelser

Betændelse i øjet eller øget tåreflåd

Hævelse forårsaget af mangelfuld drænage af lymfe

Åndedrætsbesvær

Næseflåd, betændelse i hals og næse, hoste

Næseblod

Mundsår

Opstød fra maven inklusive kvalme, opkastning og diarré, forstoppelse

Mavesmerter

Fordøjelsesbesvær

Hårtab: I de fleste tilfælde vil normal hårvækst vende tilbage

. I nogle tilfælde (hyppighed

ikke kendt) er der observeret permanent hårtab

Rødme og hævelse af håndflader eller fodsåler, hvilket kan få huden til at skalle af (dette kan

også forekomme på arme, ansigt eller krop)

Ændring af neglenes farve, som også kan løsne sig

Muskelømhed og smerter, rygsmerter eller knoglesmerter

Ændring eller udeblivelse af menstruationer

Hævelse af hænder, fødder eller ben

Træthed eller influenza-lignende symptomer

Vægtforøgelse eller vægttab

Almindelige

(kan forekomme hos op til 1 ud af 10 patienter)

:

Betændelse i munden med hvid skimmelsvamp (Candida Albicans)

Dehydrering

Svimmelhed

Nedsat hørelse

Fald i blodtrykket, uregelmæssig eller hurtig hjerterytme

Hjertesvigt

Betændelse i spiserøret

Mundtørhed

Synkebesvær eller smerter ved synkning

Blødninger

Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)

Ikke almindelige

(kan forekomme hos op til 1 ud af 100 patienter):

Besvimelse

Hudreaktioner på injektionsstedet, betændelse eller hævelse af venen (flebitis)

Betændelse i tarm eller tyndtarm, perforering af tarmene

Blodpropper

Ikke kendt

(kan ikke estimeres ud fra forhåndenværende data):

Interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.

Betændelse i lungerne kan også udvikles, når docetaxelbehandling anvendes sammen med

strålebehandling).

Pneumoni (lungebetændelse)

Lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød)

Sløret syn pga. hævet nethinde (cystoidt makulaødem)

Nedsat indhold af natrium, kalium, magnesium og/eller calcium i blodet (forstyrrelse i

elektrolytbalancen).

Ventrikulær arytmi eller ventrikulær takykardi (manifesteret som uregelmæssig og / eller hurtig

hjerterytme, alvorlig åndenød, svimmelhed og / eller besvimelse). Nogle af disse symptomer

kan være alvorlige. Hvis dette sker, skal du omgående fortælle det til lægen.

Reaktioner på injektionsstedet på stedet for en tidligere reaktion.

Indberetning af bivirkninger

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder

også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan

også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem

anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere

information om sikkerheden af dette lægemiddel.

5.

Opbevaring

Opbevar dette lægemiddel utilgængeligt for børn.

Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er

den sidste dag i den nævnte måned.

Må ikke opbevares ved temperaturer over 25 ºC.

Opbevares i den originale pakning for at beskytte mod lys.

Anvend hætteglasset umiddelbart efter åbning. Hvis det ikke anvendes straks, er opbevaringstid og

-forhold brugerens ansvar.

Fra et mikrobiologisk synspunkt skal rekonstitution/fortynding foretages under kontrollerede og

aseptiske forhold.

Anvend lægemidlet umiddelbart efter tilsætning til infusionsposen. Hvis det ikke anvendes straks, er

opbevaringstid og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved

opbevaring under 25 °C inklusive den time, patienten får infusionen.

Den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i infusionsposer uden

indhold af PVC er påvist at være op til 48 timer ved opbevaring mellem 2 °C og 8 °C.

Præparer infusionsopløsningen efter retningslinjerne. Infusionsopløsningen må ikke være forbundet

med infusionssættet i mere end 8 timer ved opbevaring ved 25°C.

Docetaxel infusionsvæske er overmættet, den kan derfor udkrystallisere over tid. Hvis der forekommer

krystaller, må opløsningen ikke længere anvendes og den skal kasseres.

Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide

medicinrester i afløbet.

6.

Pakningsstørrelser og yderligere oplysninger

Docetaxel Accord indeholder:

Aktivt stof: docetaxel. Hver ml koncentrat til infusionsvæske indeholder 20 mg docetaxel.

Et hætteglas med 1 ml koncentrat indeholder 20 mg docetaxel.

Et hætteglas med 4 ml koncentrat indeholder 80 mg docetaxel.

Et hætteglas med 8 ml koncentrat indeholder 160 mg docetaxel.

Øvrige indholdsstoffer: polysorbat 80, vandfri ætanol (pkt. 2) og vandfri citronsyre.

Udseende og pakningsstørrelser

Docetaxel Accord koncentrat til infusionsvæske, opløsning er en klar, lys gul til brunliggul opløsning.

Docetaxel Accord 20 mg/1 ml leveres i et 5 ml klart glashætteglas med fluorotec plus gummilukning

og aluminiumforsegling og en orange afrivningshætte.

Docetaxel Accord 80 mg/4 ml leveres i et 5 ml klart glashætteglas med fluorotec plus gummilukning

og aluminiumforsegling og en rød afrivningshætte.

Docetaxel

Accord

mg/8

leveres

klart

glashætteglas

fluorotec

plus

gummilukning og aluminiumforsegling og en rød afrivningshætte.

Pakningsstørrelse:

Hver karton indeholder et hætteglas med 1 ml koncentrat.

Hver karton indeholder et hætteglas med 4 ml koncentrat

Hver karton indeholder et hætteglas med 8 ml koncentrat

Indehaver af markedsføringstilladelsen og fremstiller:

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow, Middlesex HA1 4HF

Storbritannien

Denne indlægsseddel blev senest ændret.

Andre informationskilder

Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs

hjemmeside http://www.ema.europa.eu/.

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL ACCORD KONCENTRAT

TIL INFUSIONSVÆSKE, OPLØSNING

Det er vigtigt at læse hele denne vejledning inden fremstilling af Docetaxel Accord infusionsvæske.

Anbefaling for sikker håndtering

Docetaxel er et antineoplastisk lægemiddel og, som med andre potentielt giftige lægemidler, skal der

udvises forsigtighed under håndtering og tilberedning af opløsninger heraf. Det anbefales at bruge

handsker.

Hvis Docetaxel Accord koncentratet eller infusionsvæske skulle komme i berøring med huden, skal

man straks vaske sig grundigt med vand og sæbe. Hvis det skulle komme i berøring med slimhinderne,

skal man straks skylle grundigt med vand.

Tilberedning til intravenøs administration

Tilberedning af infusionsvæske

Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen

med dette lægemiddel (Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som

kun indeholder 1 hætteglas).

Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen

med dette lægemiddel (Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som

kun indeholder 1 hætteglas).

Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen

med dette lægemiddel (Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som

kun indeholder 1 hætteglas).

Docetaxel

Accord

koncentrat

til

infusionsvæske,

opløsning

kræver

INGEN

forudgående

fortynding med en solvens, men er klar til tilsætning til infusionsvæske.

Hvert hætteglas er til engangsbrug og bør anvendes straks efter anbrud. Hvis det ikke anvendes

straks, er opbevaringstid og -forhold brugerens ansvar. For at kunne udtage den korrekte dosis til

patienten, kan det være nødvendigt at anvende mere end et hætteglas Docetaxel Accord

koncentrat til infusionsvæske, opløsning. En dosis på 140 mg docetaxel kræver f.eks. 7 ml

docetaxel koncentrat til infusionsvæske.

Udtag aseptisk den ønskede mængde Docetaxel Accord koncentrat til infusionsvæske,

opløsning, med en kalibreret sprøjte.

Koncentration af docetaxel i Docetaxel Accord er 20 mg/ml.

Injicer via en enkelt injektion (et stik) den nødvendige mængde Docetaxel Accord koncentrat til

infusionsvæske, opløsning i en 250 ml infusionspose indeholdende enten en 5 %

glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske. Hvis det er nødvendigt at

anvende doser, som er større end 190 mg docetaxel, skal der anvendes et større volumen af

infusionsvæsken, så man ikke overstiger en koncentration på 0,74 mg docetaxel/ml.

Bland manuelt opløsningen i infusionposen med vippende bevægelser.

Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske

forhold og lægemidlet bør anvendes umiddelbart herefter. Hvis det ikke anvendes straks, er

opbevaringstid og -forhold brugerens ansvar.

Efter den anbefalede tilsætning til infusionsposen er docetaxel-infusionsopløsningen stabil i 6

timer, hvis den opbevares under 25 °C. Den bør anvendes indenfor 6 timer (inklusive den time,

patienten får infusionen).

Endvidere er den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i

infusionsposer uden indhold af PVC påvist at være op til 48 timer ved opbevaring mellem 2 °C

og 8 °C.

Docetaxel infusionsvæske er overmættet, den kan derfor udkrystallisere over tid. Hvis der

forekommer krystaller, må opløsningen ikke længere anvendes og den skal kasseres.

Som ved alle andre parenterale lægemidler skal Docetaxel Accord infusionsvæske kontrolleres

visuelt for uklarheder, og opløsninger med udfældning skal kasseres.

Affald

Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal destrueres i

overrensstemmelse med lokale retningslinjer. Spørg på apoteket, hvordan du skal bortskaffe

medicinrester. Af hensyn til miljøet må du ikke smide medicinrester i afløbet.

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

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

6-4-2018

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

Health Canada is advising Canadians that one lot of “Organic Traditions Shatavari Powder” is being voluntarily recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination, which may pose serious health risks. According to Advantage Health Matters Inc., 13 units from the affected lot were distributed. Of the 13 units, only 2 packages, sold at Choices Markets Yaletown (1202 Richards Street) in Vancouver, B.C., have not been recovered.

Health Canada

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

Danish Medicines Agency

22-1-2018

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

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

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

16-5-2018

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

Europe -DG Health and Food Safety

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety