Topotecan "Accord"

Primær information

  • Handelsnavn:
  • Topotecan "Accord" 1 mg/ml koncentrat til infusionsvæske, opløsning
  • Dosering:
  • 1 mg/ml
  • Lægemiddelform:
  • koncentrat til infusionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

Lokation

  • Fås i:
  • Topotecan "Accord" 1 mg/ml koncentrat til infusionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 48501
  • Sidste ændring:
  • 17-07-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

Topotecan Accord 1 mg/ml koncentrat til infusionsvæske, opløsning

Topotecan

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 eller apoteketspersonalet, hvis der er mere, du vil vide.

Lægen har ordineret Topotecan Accord til dig personligt. Lad derfor være med at give det til andre. Det

kan være skadeligt for andre, selvom de har de samme symptomer, som du har.

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

nævnt her.

Oversigt over indlægssedlen

1. Virkning og anvendelse

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

3. Sådan skal du tage Topotecan Accord

4. Bivirkninger

5. Opbevaring

6. Pakningsstørrelser og yderligere oplysninger

1.

Virkning og anvendelse

Topotecan Accords virkning:

Topotecan Accord hjælper med til at ødelægge kræftsvulster. Medicinen gives som intravenøs infusion i en

vene (drop) på hospitalet af en læge eller sygeplejerske.

Topotecan Accord anvendes til:

Topotecan Accord anvendes til at behandle:

ovariekræft eller småcellet lungekræft, der er kommet igen efter kemoterapi

fremskreden

livmoderhalskræft, hvis

behandling

kirurgi

eller

stråleterapi ikke

mulig. Ved

behandling af livmoderhalskræft anvendes Topotecan Accord sammen med et andet lægemiddelstof, som

kaldes cisplatin.

Din læge vil sammen med dig beslutte, om behandling med Topotecan Accord er bedre end at fortsætte

med den kemoterapi, du tidligere har fået.

2.

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

Lægen kan have foreskrevet anden anvendelse eller dosering end angivet i denne information. Følg altid

lægens anvisning og oplysningerne på doseringsetiketten.

Tag ikke Topotecan Accord

hvis du er overfølsom (allergisk) over for topotecan eller et af de øvrige indholdsstoffer i Topotecan

Accord (angivet i pkt. 6).

hvis du ammer.

hvis dit blodcelletal er for lavt. Din læge vil give dig besked om dette på baggrund af resultaterne fra

din sidste blodprøve.

Fortæl det til lægen, hvis et eller flere af ovenstående forhold gælder for dig.

Advarsler og forsigtighedsregler

Inden du får denne medicin, skal du fortælle det til lægen, hvis

du har nyre- eller leverproblemer. Måske skal din dosis af Topotecan Accord justeres.

du er gravid eller planlægger at blive gravid

du planlægger at blive far

Topotecan Accord kan skade det ufødte barn før, under og lige efter behandlingen. Du skal bruge en effektiv

præventionsmetode. Spørg lægen til råds.

Topotecan

Accord

skade

lunger.

Risikoen

lungeskader

større,

hvis

haft

lungesygdom, lungekræft, har fået strålebehandling af lungerne, har taget medicin, der kan give lungeskader,

eller har såkaldt rygerlunge.

Den læge, der behandler dig, vil undersøge din lungefunktion med jævne mellemrum og kan beslutte at

stoppe behandlingen, hvis du får symptomer såsom hoste, feber og/eller vejrtrækningsproblemer.

Topotecan Accord kan medføre et fald i antallet af de blodceller, der får blodet til at størkne (blodplader).

Dette kan medføre alvorlig blødning fra relativt små sår, f.eks. hvis man skærer sig. I sjældne tilfælde kan

dette føre til alvorlig blødning (hæmoragi).

Hvis din generelle helbredstilstand ikke er god, er sandsynligheden for, at du får bivirkninger under

behandlingen med Topotecan Accord større. Behandlingen kan også være mindre effektiv.

Fortæl det til lægen, hvis et eller flere af ovenstående forhold gælder for dig. Din læge vil vurdere din

generelle helbredstilstand under behandlingen, og du skal sige det til lægen, hvis du får feber, infektion eller

føler dig utilpas (se også pkt. 4 ‘Bivirkninger’).

Brug anden medicin sammen med Topotecan Accord

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

naturlægemidler og medicin, som ikke er købt på recept.

Husk at fortælle det til lægen, hvis du begynder at tage anden medicin under behandlingen med Topotecan

Accord.

Brug af Topotecan Accord sammen med mad, drikke og alkohol

Der er ingen kendt interaktion mellem Topotecan Accord og alkohol. Du bør dog spørge din lægen om,

hvorvidt det er tilrådeligt for dig at indtage alkohol.

Graviditet, amning og fertilitet

Topotecan Accord anbefales ikke til gravide kvinder. Det kan skade det ufødte barn før, under og i mindst

seks måneder efter behandling. Du skal bruge en effektiv præventionsmetode. Spørg lægen til råds. Forsøg

ikke at blive gravid/blive far, før lægen siger, at det er sikkert.

Mandlige patienter, der ønsker at blive fædre, bør spørge lægen til råds om familieplanlægning eller

behandling. Hvis graviditet indtræder under behandlingen, skal du straks fortælle det til din læge.

Du må ikke amme, hvis du modtager behandling med Topotecan Accord. Du må ikke begynde at amme

igen, før lægen siger, at der ikke er nogen risiko forbundet med det.

Trafik- og arbejdssikkerhed

Topotecan Accord kan medføre træthed.

Kør ikke bil og betjen ikke maskiner, hvis du føler dig træt eller svag.

3.

Sådan skal du bruge Topotecan Accord

Den dosis Topotecan Accord, som du vil få, vil blive beregnet af din læge på grundlag af:

din kropsstørrelse (overfladeareal målt i kvadratmeter)

resultaterne af de blodprøver, som er taget inden behandlingens start

din sygdom

Den anbefalede dosis er

behandling

ovariecancer

småcellet

lungecancer:

kvadratmeter

kropsoverfladeareal pr. dag.

til behandling af livmoderhalskræft: 0,75 mg pr. kvadratmeter kropsoverfladeareal pr. dag.

Ved behandling af livmoderhalskræft anvendes Topotecan Accord sammen med et andet lægemiddel, som

kaldes cisplatin. Din læge vil fortælle dig om den korrekte dosering af cisplatin.

Sådan klargøres Topotecan Accord

Topotecan Accord leveres som koncentrat til infusionsvæskeopløsning. Koncentratet skal fortyndes, inden

det indgives.

Sådan gives Topotecan Accord

En læge eller sygeplejerske vil give dig en passende dosis af Topotecan Accord som infusion (drop). Det

indgives almindeligvis i armen over en periode på ca. 30 minutter.

ved ovariecancer og småcellet lungecancer vil du blive behandlet én gang om dagen i 5 dage.

ved livmoderhalskræft vil du blive behandlet én gang om dagen i 3 dage.

For alle kræfttyper vil behandlingsserierne sædvanligvis blive gentaget hver tredje uge.

Behandlingen kan variere afhængig af resultaterne af dine blodprøver.

Stop af behandlingen

Din læge vil beslutte, hvornår behandlingen skal stoppes.

4.

Bivirkninger

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

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/

Alvorlige bivirkninger: Tal med din læge

Meget almindelige bivirkninger: forekommer hos flere end 1 ud af 10 patienter

Tegn på infektion. Topotecan Accord kan nedsætte antallet af hvide blodceller og nedsætte din

modstandsdygtighed over for infektion. Dette kan endog blive livstruende. Tegnene omfatter:

feber

alvorlig forværring af din generelle tilstand

lokale symptomer såsom halssmerter eller urinvejsproblemer (f.eks. en brændende følelse, når

du tisser, hvilket kan være et tegn på urinvejsinfektion)

lejlighedsvise, stærke mavesmerter, feber og muligvis diarré (sjældent med blod) kan være tegn

på tyktarmsbetændelse (colitis).

Sjældne bivirkninger: forekommer hos 1 til 10 ud af 10.000 patienter

Lungebetændelse (interstitiel lungesygdom): Du har størst risiko, hvis du har eksisterende lungesygdom,

har fået strålebehandling af dine lunger eller tidligere har fået medicin, som gav lungeskader. Symptomer

inkluderer:

vejrtrækningsbesvær

hoste

feber

Kontakt straks din læge, hvis du får nogle af disse symptomer, da hospitalsindlæggelse kan være nødvendig.

Meget almindelige bivirkninger: forekommer hos flere end 1 ud af 10 patienter

- Følelse af almen slaphed og træthed (forbigående blodmangel). I nogle tilfælde kan det være nødvendigt, at

du får en blodtransfusion.

- Unormalt lavt antal hvide blodceller (neutropeni), der kan være ledsaget af feber og tegn på infektion

(febril neutropeni).

- Usædvanlige blå mærker eller blødning, som er forårsaget af et fald i antallet af de celler, som får blodet til

at størkne. Dette kan føre til alvorlige blødninger fra relativt små skader, f.eks. en lille rift. I sjældne tilfælde

kan det resultere i en mere alvorlig blødning (hæmoragi). Tal med din læge om, hvordan risikoen for

blødninger kan minimeres.

- Vægttab og tab af appetit (anoreksi), træthed, svaghed, utilpashed.

- Utilpashed (kvalme), følelse af at være syg (opkastning) diarré, mavesmerter, forstoppelse.

- Betændelse og sår i munden, på tungen og gummerne.

- Forhøjet kropstemperatur (feber)

- Hårtab.

Almindelige bivirkninger: forekommer hos 1 til 10 ud af 100 patienter

- Allergi og overfølsomhedsreaktioner (herunder udslæt)

- Gulfarvning af huden

- Kløende fornemmelse

- Muskelsmerter

- Alvorlig infektion (sepsis)

- Utilpashed

Sjældne bivirkninger: forekommer hos 1 til 10 ud af 10.000 patienter

- Alvorlige allergiske eller anafylaktiske reaktioner, der medfører hævede læber, hævet ansigt eller hals og

fører til alvorlig vejrtrækningsbesvær, hududslæt eller nældefeber, anafylaktisk shock (et alvorligt fald i

blodtrykket, bleghed, ophidselse, svag puls, nedsat bevidsthed.

- Hævelser, der er forårsaget af væskeophobninger (angioødemer).

- Milde smerter og betændelse på injektionsstedet.

- Kløende udslæt (eller nældefeber).

Hvis du er i behandling for livmoderhalskræft, kan du få bivirkninger af den anden medicin (cisplatin),

som du vil få sammen med Topotecan Accord. Disse bivirkninger er anført i indlægssedlen for cisplatin.

Meget sjældne bivirkninger forekommer hos færre end 1 ud af 10.000 patienter

- Udtrædning af blod i vævet (ekstravasation).

Hvis du får bivirkninger

Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af

denne indlægsseddel.

5.

Opbevaring

Opbevares utilgængeligt for børn.

Brug ikke Topotecan til infusionsvæske, opløsning, efter den udløbsdato, der står på pakningen.

Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.

Opbevares ved temperaturer under 25°C.

Opbevar hætteglasset i den ydre karton for at beskytte mod lys.

Dette lægemiddel er til engangsbrug. Det skal fortyndes straks efter åbning.

Kemisk og fysisk brugsstabilitet er demonstreret i 30 dage ved 25°C under normale lysforhold og ved 2-8°C

beskyttet mod lys.

Fra et mikrobiologisk synspunkt bør produktet anvendes med det samme. Hvis det ikke anvendes med det

samme, er opbevaringstid- og -forhold før anvendelse brugerens ansvar og vil normalt ikke overstige 24

timer ved 2 til 8°C, medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske

forhold.

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

medicinrester i afløbet eller skraldespanden.

6.

Pakningsstørrelser og yderligere oplysninger

Topotecan Accord indeholder

Aktivt stof: topotekan hydrochlorid. Hvert 1 ml hætteglas med koncentrat indeholder 1 mg topotecan

(som hydrochlorid)

Hvert 4 ml hætteglas med koncentrat indeholder 4 mg topotecan (som hydrochlorid)

Øvrige indholdsstoffer: vinsyre (E334), vand til injektionsvæske og saltsyre (E507) eller

natriumhydroxid (til justering af pH-værdi).

Udseende og pakningsstørrelser

Dette lægemiddel er et koncentrat til infusionsvæske, opløsning.

Koncentratet er en klar, gul opløsning. Det er fyldt på et ravgult hætteglas, der er lukket med Flurotec-

gummiprop og aluminium-flip off-forsegling.

Hvert 1 ml hætteglas indeholder 1 mg topotecan (som hydrochlorid).

Hvert 4 ml hætteglas indeholder 4 mg topotecan (som hydrochlorid).

Dette lægemiddel fås i to pakningsstørrelser, indeholdende enten 1 hætteglas eller 5 hætteglas.

Ikke alle pakningsstørrelser er nødvendigvis markedsført.

Indehaver af markedsføringstilladelsen

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF, Storbritannien

Fremstiller:

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF, Storbritannien

Cemelog BRS, H2040 Budaörs, Vasút u. 13, Ungarn

Dette lægemiddel er godkendt i EEA’s medlemslande under følgende navne:

Medlemslandets

navn

Lægemidlets navn

Storbritannien

Topotecan Accord 1 mg/ml Concentrate for Solution for Infusion

Østrig

Topotecan Accord 1 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Belgien

Topotecan Accord Healthcare 1 mg/ml Solution à Diluer pour Perfusion /

concentraat voor oplossing voor infusie / Konzentrat zur Herstellung einer

Infusionslösung

Bulgarien

Topotecan Accord 1 mg/ml Concentrate for Solution for Infusion

Cypern

Topotecan Accord Healthcare 1 mg Concentrate for Solution for Infusion

Republikken

Tjekkiet

Topotecan Accord 1 mg/ml Koncentrát pro Přípravu Infuzního Roztoku

Tyskland

Topotecan Accord 1 mg/ml Konzentrat zur Herstellung einer

Infusionslösung

Danmark

Topotecan Accord

Estland

Topotecan Accord 1 mg/ml

Grækenland

Τοποτεκάνη Accord 1 mg / ml Πυκνό Διάλυμα για έγχυση

Spanien

Topotecán Accord 1 mg/ml concentrado para solución para perfusión

Finland

Topotecan Accord 1 mg/ml Infuusiokonsentraatti, Liuosta

Varten/koncentrat till infusionsvätska, lösning

Frankrig

Topotecan Accord 1 mg/ml Solution à Diluer pour Perfusion

Ungarn

Topotecan Accord 1 mg/ml Concentrate for Solution for Infusion

Irland

Topotecan Accord 1 mg/ml Concentrate for Solution for Infusion

Italien

Topotecan AHCL

Letland

Topotecan Accord Healthcare 1 mg/ml koncentrāts infūziju šķīduma

pagatavošanai

Litauen

Topotecan Accord 1mg/ml koncentratas infuziniam tirpalui

Malta

Topotecan Accord 1 mg/ml Concentrate for Solution for Infusion

Polen

Topotecanum Accord

Holland

Topotecan Accord 1 mg/ml Concentraat voor Oplossing voor Infusie

Norge

Topotecan Accord 1 mg/ml Konsentrat til infusjonsvæke

Portugal

Topotecan Accord

Rumænien

Topotecan Accord 1 mg / ml concentrat pentru soluţie perfuzabilă.

Republikken

Slovakiet

Topotecan Accord 1 mg/ml concentrate for solution for infusion

Slovenien

Topotekan Accord 1 mg/ml koncentrat za raztopino za infundiranje

Sverige

Topotecan Accord 1 mg/ml Koncentrat till Infusionsvätska, Lösning

Denne indlægsseddel blev senest revideret 05/2012

Følgende oplysninger er tiltænkt læger og sundhedspersonale:

Instruktioner vedrørende præparering, opbevaring og destruktion af Topotecan Accord

Instruktioner vedrørende fortynding

Koncentratet er en klar, gul opløsning og indeholder 1 mg pr. ml topotecan. Yderligere fortynding for at nå

en passende koncentration kan foretages med enten 9 mg/ml (0,9 %) natriumchlorid til infusionsvæske eller

50 mg/ml (5 %) glucose til infusionsvæske for at opnå en endelig koncentration på mellem 25 og 50

mikrogram/ml.

Opbevaring af den fortyndede opløsning

Kemisk og fysisk brugsstabilitet er demonstreret i 30 dage ved 25°C under normale lysforhold og ved 2-8°C

beskyttet mod lys. Fra et mikrobiologisk synspunkt bør produktet anvendes med det samme. Hvis det ikke

anvendes med det samme, er opbevaringstid- og -forhold før anvendelse brugerens ansvar og vil normalt

ikke overstige 24 timer ved 2 til 8°C, medmindre fortyndingen har fundet sted under kontrollerede og

validerede aseptiske forhold.

Håndtering og destruktion

De normale procedurer for korrekt håndtering og bortskaffelse af anticancermedicin skal overholdes, dvs.:

Personale skal oplæres i rekonstitution af medikamentet.

Gravide kvinder blandt personalet må ikke arbejde med dette medikament.

Personale,

håndterer

dette

medikament

under

rekonstitution,

skal

bære

beskyttelsesdragt,

herunder maske, beskyttelsesbriller og handsker.

Alle

genstande

brugt

under

håndtering

eller

rengøring,

herunder

handsker,

skal

anbringes

højrisikoaffaldsposer beregnet til forbrænding ved høj temperatur.

Hvis man ved et uheld får medikamentet på huden eller i øjnene, skal der straks skylles med rigelige

mængder vand.

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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

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

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

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

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

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 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

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency