Imatinib Accord

Glavna informacija

  • Trgovački naziv:
  • Imatinib Accord
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Imatinib Accord
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Inhibitori proteinske kinaze
  • Područje terapije:
  • Leukemija, mijelogeni, kronični, BCR-ABL pozitivan
  • Terapijske indikacije:
  • Imatinib Accord je indiciran za liječenje:.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002681
  • Datum autorizacije:
  • 01-07-2013
  • EMEA koda:
  • EMEA/H/C/002681
  • Zadnje ažuriranje:
  • 28-02-2018

Izvješće o ocjeni javnog

EMA/393159/2017

EMEA/H/C/002681

EPAR, sažetak za javnost

Imatinib Accord

imatinib

Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Imatinib Accord. Objašnjava kako

je Agencija ocijenila lijek kako bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.

Svrha sažetka nije davati praktične savjete o primjeni lijeka Imatinib Accord.

Praktične informacije o primjeni lijeka Imatinib Accord bolesnici trebaju pročitati u uputi o lijeku,

odnosno obratiti se svojem liječniku ili ljekarniku.

Što je Imatinib Accord i za što se koristi?

Imatinib Accord je lijek protiv raka koji se koristi za liječenje sljedećih bolesti:

kronične mijeloične leukemije (KML-a), raka bijelih krvnih stanica kod kojega granulociti (vrsta

bijelih krvnih stanica) počinju nekontrolirano rasti. Lijek Imatinib Accord koristi se za liječenje

bolesnika „pozitivnih na Philadelphia kromosom” (Ph+). To znači da su se njihovi određeni geni

preraspodijelili tako da tvore poseban kromosom nazvan Philadelphia kromosom. Lijek Imatinib

Accord primjenjuje se u odraslih i djece s novodijagnosticiranim Ph+ KML-om u koje nije moguća

transplantacija koštane srži. Lijek se također koristi u odraslih i djece u „kroničnoj fazi” bolesti ako

nije uspjela terapija interferonom-alfa (drugim lijekom protiv raka) te u uznapredovalim fazama

bolesti („u fazi ubrzanja” ili „u blastičnoj krizi”).

akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph+ ALL), vrste raka kod

koje se limfociti (druga vrsta bijelih krvnih stanica) prebrzo umnožavaju. Imatinib Accord

primjenjuje se zajedno s drugim lijekovima protiv raka u odraslih i djece s novodijagnosticiranim

Ph+ ALL-om. Primjenjuje se također kao monoterapija za liječenje odraslih osoba u kojih se

Ph+ ALL vratio nakon prethodnog liječenja ili u osoba koje ne reagiraju na druge lijekove;

mijelodisplastičnih ili mijeloproliferativnih bolesti (MD/MPD), skupine bolesti kod kojih tijelo

proizvodi veliki broj abnormalnih krvnih stanica. Imatinib Accord koristi se za liječenje odraslih

bolesnika s MD/MPD-om s preraspodjelom gena za receptor faktora rasta koji potječe od

trombocita (PDGFR);

Imatinib Accord

EMA/393159/2017

Stranica 2/3

uznapredovalog hipereozinofilnog sindroma (HES) ili kronične eozinofilne leukemije (KEL), bolesti

kod kojih eozinofili (druga vrsta bijelih krvnih stanica) počinju nekontrolirano rasti. Imatinib Accord

koristi se za liječenje odraslih bolesnika s HES-om ili KEL-om sa specifičnom preraspodjelom dvaju

gena naziva FIP1L1 i PDGFRα;

dermatofibrosarkoma protuberans (DFSP), vrste raka (sarkoma) kod koje se stanice u tkivu ispod

kože nekontrolirano dijele. Imatinib Accord koristi se za liječenje odraslih bolesnika s DFSP-om koji

se ne može kirurški ukloniti i odraslih bolesnika koji ne mogu biti podvrgnuti kirurškom zahvatu u

slučaju kada se rak ponovo razvio nakon prethodnog liječenja ili se proširio na druge dijelove tijela.

Imatinib Accord sadrži djelatnu tvar imatinib. To je „generički lijek”. To znači da Imatinib Accord sadrži

istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU)

pod nazivom Glivec. Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i

odgovorima ovdje

Kako se Imatinib Accord koristi?

Imatinib Accord dostupan je u obliku tableta (100 i 400 mg). Izdaje se samo na liječnički recept, a

liječenje mora započeti liječnik koji ima iskustva u liječenju osoba oboljelih od raka krvi ili solidnih

tumora. Imatinib Accord uzima se kroz usta uz obrok i veliku čašu vode kako bi se smanjio rizik od

iritacije želuca i crijeva. Doza ovisi o bolesti koja se liječi, dobi i stanju bolesnika te o reakciji na

terapiju, ali ne smije premašiti 800 mg dnevno. Za dodatne informacije vidjeti uputu o lijeku.

Kako djeluje Imatinib Accord?

Djelatna tvar lijeka Imatinib Accord je imatinib, inhibitor protein-tirozin kinaze. To znači da blokira

određene enzime poznate pod nazivom tirozin kinaze. Ti se enzimi nalaze u nekim receptorima na

površini stanica raka, uključujući i receptore koji sudjeluju u stimulaciji nekontrolirane diobe stanica.

Blokiranjem tih receptora lijek Imatinib Accord pomaže u kontroli diobe stanica.

Kako je Imatinib Accord ispitivan?

Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim uporabama već su provedena za

referentni lijek Glivec te se ne trebaju ponavljati za lijek Imatinib Accord.

Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Imatinib Accord. Tvrtka je provela i

ispitivanja koja su pokazala da je lijek „bioekvivalentan” referentnom lijeku Glivec. Dva su lijeka

bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari pa se stoga očekuje i da imaju

jednak učinak.

Koje su koristi i rizici od lijeka Imatinib Accord?

Budući da je lijek Imatinib Accord generički lijek te da je bioekvivalentan referentnom lijeku, smatra se

da su njegove koristi i rizici isti kao i kod referentnog lijeka.

Zašto je Imatinib Accord odobren?

Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Imatinib

Accord posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Glivec. Stoga je stav

Imatinib Accord

EMA/393159/2017

Stranica 3/3

Agencije da, kao i kod lijeka Glivec, koristi nadmašuju utvrđene rizike. Agencija je preporučila

izdavanje odobrenja za stavljanje u promet lijeka Imatinib Accord u EU-u.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Imatinib Accord?

Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i

učinkovite primjene lijeka Imatinib Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku

Ostale informacije o lijeku Imatinib Accord

Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Imatinib Accord na snazi u

Europskoj uniji od 1. srpnja 2013.

Cjeloviti EPAR za lijek Imatinib Accord nalazi se na internetskim stranicama Agencije:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports

. Za više

informacija o liječenju lijekom Imatinib Accord pročitajte uputu o lijeku (također dio EPAR-a), odnosno

obratite se svom liječniku ili ljekarniku.

Cjeloviti EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.

Sažetak je posljednji put ažuriran u 06. 2017.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacija za bolesnika

Imatinib Accord 100 mg filmom obložene tablete

Imatinib Accord 400 mg filmom obložene tablete

imatinib

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku

sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.Pogledajte dio

Što se nalazi u ovoj uputi:

Što jeImatinib Accordi za što se koristi

Što morate znati prije nego počnete uzimatiImatinib Accord

Kako uzimatiImatinib Accord

Moguće nuspojave

Kako čuvati Imatinib Accord

Sadržaj pakiranjai druge informacije

1.

Što je Imatinib Accordi za što se koristi

Imatinib Accord je lijek koji sadrži djelatnu tvar zvanu imatinib. Ovaj lijek djeluje tako da inhibira rast

abnormalnih stanica kod niže navedenih bolesti. One obuhvaćaju i neke vrste raka.

Imatinib Accord se kod odraslih osoba i djece koristi za liječenje:

Kronične mijeloične leukemije (KML). Leukemija je rak bijelih krvnih stanica. Te bijele

krvne stanice obično pomažu tijelu u borbi protiv infekcije. Kronična mijeloična leukemija je

oblik leukemije u kojem određene abnormalne bijele krvne stanice (zvane mijeloidne stanice)

počinju nekontrolirano rasti.

Akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph-pozitivni

ALL). Leukemija je rak bijelih krvnih stanica. Te bijele krvne stanice obično pomažu tijelu u

borbi protiv infekcije. Akutna limfoblastična leukemija je oblik leukemije u kojem određene

abnormalne bijele krvne stanice (zvane limfoblasti) počinju nekontrolirano rasti. Imatinib

Accord inhibira rast ovih stanica.

Imatinib Accord se kod odraslih osoba koristi za liječenje:

Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD). One čine skupinu bolesti krvi

u kojima određene krvne stanice počinju nekontrolirano rasti. Imatinib Accord inhibira rast ovih

stanica u određenoj podvrsti ovih bolesti.

Hipereozinofilnog sindroma (HES) i/ili kronične eozinofilne leukemije (KEL). To su bolesti

krvi u kojima određene krvne stanice (zvane eozinofili) počinju nekontrolirano rasti. Imatinib

Accord inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.

Dermatofibrosarkoma protuberans (DFSP). DFSP je rak tkiva ispod kože u kojem neke

stanice počinju nekontrolirano rasti. Imatinib Accord inhibira rast ovih stanica.

U ostatku ove upute o lijeku koristiti ćemo kratice prilikom spominjanja ovih bolesti.

Ako imate bilo kakvih pitanja o tome na koji način djeluje Imatinib Accord, ili zašto je taj lijek Vama

propisan, obratite se svom liječniku.

2.

Što morate znati prije nego počnete uzimatiImatinib Accord

Imatinib Accord Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka

krvi ili solidnihtumora.

Pažljivo slijedite sve upute dobivene od liječnika, čak i onda ako se razlikuju od općih informacija

sadržanih u ovoj uputi.

Nemojte uzimatiImatinib Accord:

ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).

Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Accorda.

Ako mislite da bi mogli biti alergični, ali niste sigurni, posavjetujte se sa svojim liječnikom.

Upozorenja i mjere opreza

Obratite se svom liječniku prije negouzmete Imatinib Accord:

ako imate, ili ste ikada imali, problema s jetrom, bubrezima ili srcem.

ako uzimate lijek levotiroksin, jer Vam je uklonjena štitnjača.

ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B. To je potrebno jer

Imatinib Accord može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima

može rezultirati smrtnim ishodom. Prije početka liječenja liječnik će pažljvo pregledati

bolesnike radi utvrđivanja eventualnih znakova te infekcije.

Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Imatinib

Accorda.

Tijekom liječenja Imatinib Accordomodmah obavijestite svog liječnika ako vrlo brzo dobivate na

težini. Imatinib Accord može izazvati zadržavanje vode u tijelu (izrazito zadržavanjetekućine).

Dok uzimate Imatinib Accord, liječnik će redovito pratiti da li lijek djeluje. Također ćete redovito

provoditi krvne pretrage i mjeriti tjelesnu težinu.

Djeca i adolescenti

Imatinib Accord se kod djece također koristi za liječenje KML-a. Ne postoji iskustvo kod djece s

KML-om mlađe od 2 godine. Postoji ograničeno iskustvo kod djece s Ph-pozitivnim ALL-om te vrlo

ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, i HES/KEL-om.

Kod neke djece i adolescenata koji uzimaju Imatinib Accord rast može biti sporiji od normalnog.

Liječnik će pratiti rast prilikom redovitih pregleda.

Drugi lijekovi i Imatinib Accord

Obavijestite svog liječnika ili ljekarnika ako uzimate , nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove, uključujući lijekove dobivene bez recepta (poput paracetamola) i biljne pripravke

(poput gospine trave). Neki lijekovi mogu utjecati na djelovanje Imatinib Accorda kada se uzimaju

zajedno. Oni mogu povećati ili smanjiti učinak Imatinib Accorda bilo povećanjem nuspojava ili

smanjenjem učinka Imatinib Accorda. Imatinib Accord može to isto napraviti nekim drugim

lijekovima.

Obavijestite svog liječnika ako koristite lijekove koji sprječavaju stvaranje krvnih ugrušaka.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se

svom liječniku za savjet prije nego uzmete ovaj lijek.

Imatinib Accord se ne smije upotrebljavati tijekom trudnoće, osim ako to nije neophodno.

Liječnik će Vam objasniti moguće rizike od uzimanja Imatinib Accorda tijekom trudnoće.

Ženama koje mogu zatrudnjeti se savjetuje primjena učinkovite kontracepcije tijekom liječenja.

Nemojte dojiti tijekom liječenja Imatinib Accordom.

Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatinib Accorda se

preporučuje da se posavjetuju sa svojim liječnikom.

Upravljanje vozilima i strojevima

Tijekom uzimanja ovog lijeka možete osjetiti omaglicu ili imati zamagljen vid. Ako se to dogodi,

nemojte voziti niti koristiti alate ili strojeve dok se ponovno ne počnete osjećati dobro.

3.

Kako uzimati Imatinib Accord

Vaš liječnik je propisao Imatinib Accord jer patite od ozbiljnog stanja. Imatinib Accord Vam može

pomoći u borbi protiv tog stanja.

Međutim, uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Važno je

da to činite onoliko dugo koliko Vam kaže liječnik ili ljekarnik. Provjerite s liječnikom ili ljekarnikom

ako niste sigurni.

Nemojte prestati uzimati Imatinib Accord, osim ako Vam to ne kaže liječnik. Ako niste u mogućnosti

uzimati ovaj lijek kako Vam je liječnik propisao ili ako osjećate da Vam više ne treba, odmah se

obratite svom liječniku.

Koliko Imatinib Accorda uzeti

Primjena uodraslih osoba

Liječnik će Vam reći točno koliko tabletaImatinib Accorda trebate uzeti.

Ako se liječite zbog KML-a:

Ovisno o Vašem stanju, uobičajena početna doza je ili 400 mg ili 600 mg:

400 mg se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg jednomna dan.

600 mgse uzima kao 6 tableta od 100 mg ili 1 tableta od 400 mg i2 tablete od 100

mgjednomna dan.

Za KML, liječnik Vam može propisati višu ili nižu dozu, ovisno o tome kako reagirate na liječenje.

Ako Vaša dnevna doza iznosi 800 mg (8 tableta od 100 mg ili 2 tablete od 400 mg), trebate uzimati 4

tablete od 100 mg ili 1 tabletu od 400 mg ujutro i 4 tablete od 100 mg ili 1 tabletu od 400 mg navečer.

Ako se liječite zbog Ph-pozitivnog ALL-a:

Početna doza je 600 mg, koja se uzima kao 6 tableta od 100 mg ili kao jedna tableta od 400 mg

te 2 tablete od 100 mg jednomna dan.

Ako se liječite zbog MDS/MPD-a:

Početna doza je 400 mg, koja se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg

jednomna dan.

Ako se liječite zbog HES/KEL-a:

Početna doza je 100 mg, a uzima se jedna tableta od 100 mg jednom dnevno. Ovisno o tome

kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, a uzimaju se 4

tablete od 100 mg ili jedna tableta od 400 mg jednom dnevno.

Ako se liječite zbog DFSP-a:

Doza je 800 mg na dan, koja se uzima kao 4 tablete od 100 mg ili 1 tableta od 400 mg ujutro i 4

tablete od 100 mg ili 1 tableta od 400 mg navečer.

Primjena u djecei adolescenata

Liječnik će Vam reći koliko tabletaImatinib Accorda trebate dati djetetu. Količina Imatinib Accorda

koju je potrebno dati ovisiti će o stanju djeteta, tjelesnoj težini i visini. Ukupna dnevna doza u djece ne

smije prijeći 800 mg kod KML-a i 600 mg kod Ph+ALL-a. Liječenje se kod Vašeg djeteta može

provoditi dozom koja se daje jednom na dan ili se dnevna doza može podijeliti u dvije primjene (pola

ujutro i pola navečer).

Kada i kako uzimati Imatinib Accord

Imatinib Accord uzimajte uz obrok. To će Vam pomoći u zaštiti od želučanih problema

prilikom uzimanja Imatinib Accorda.

Tablete progutajte cijele s velikom čašom vode.

Ako niste u mogućnosti progutati tablete, možete ih otopiti u čaši negazirane vode ili soka od jabuke:

Uzmite oko 50 ml za svaku tabletu od 100 mg ili 200 ml za svaku tabletu od 400 mg.

Miješajte žlicom sve dok se tablete potpuno ne otope.

Jednom kad se tablete otope, odmah popijte sav sadržaj čaše. Ostaci otopljenih tableta mogu

ostati u čaši.

Koliko dugo uzimatiImatinib Accord

Imatinib Accord nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.

Ako uzmete više Imatinib Accordanego što ste trebali

Ako ste zabunom uzeli previše tableta, odmah se obratite liječniku. Možda će Vam biti potrebna

medicinska skrb. Sa sobom ponesite pakovanje lijeka.

Ako ste zaboravili uzetiImatinib Accord

Ako ste zaboravili dozu, uzmite ju čim se sjetite. Međutim, ako je uskoro vrijeme za sljedeću

dozu, preskočite propuštenu dozu.

Zatim nastavite s uobičajenim rasporedom.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili

medicinskoj sestri.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga. One su

obično blage do umjerene.

Neke nuspojave mogu biti ozbiljne. Odmah obavijestite liječnika ako se kod Vas javi bilo što od

sljedećeg:

Vrlo česte (mogu se javiti u više od 1 na 10 osoba)ili česte (mogu se javiti u do 1 na 10 osoba):

brzo dobivanje na težini. Imatinib Accord može izazvati zadržavanje vode u tijelu (teška

retencija tekućine).

znakovi infekcije kao što su vrućica, teška zimica, grlobolja ili čirevi u ustima. Imatinib Accord

može smanjiti broj bijelih krvnih stanica, pa možete lakše dobiti infekciju.

neočekivano krvarenje ili pojava masnica (kada se niste ozlijedili).

Manje česte (mogu se javiti u do 1 na 100 osoba) ili rijetke (mogu se javiti u do 1 na 1000 osoba):

bolovi u prsima, nepravilan srčani ritam (znakovi srčanih problema).

kašalj, otežano disanje ili bolno disanje (znakovi plućnih problema).

osjećaj ošamućenosti, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).

mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s

jetrom).

osip, crvenilo kože s mjehurićima na usnama, očima, koži ili u ustima, ljuštenje kože, vrućica,

izdignute crvene ili ljubičastemrljena koži, svrbež, osjećaj žarenja, pojava gnojnih mjehurića

(znakovi kožnih problema).

teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi

probavnih problema).

jako smanjeno mokrenje, osjećaj žeđi (znakovi bubrežnih problema).

mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema).

teška glavobolja, slabost ili oduzetostudova ili lica, otežan govor, iznenadni gubitak svijesti

(znakovi problema živčanog sustava kao što su krvarenje ili oticanje u lubanji/mozgu).

blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih

krvnih stanica).

bol u očima ili slabljenje vida, krvarenje u očima.

bol u kukovima ili otežano hodanje.

utrnuli ili hladni prsti na nogama i rukama (znakovi Raynaudovog sindroma).

iznenadno oticanje i crvenilo kože (znakovi kožne infekcije zvane celulitis).

oslabljen sluh.

mišićna slabost i grčevi mišića s abnormalnim srčanim ritmom (znakovi promjena količine

kalija u krvi).

modrice.

bol u trbuhu s mučninom.

grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi

mišićnih problema).

bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice,

omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili

maternicom).

mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj

nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke

razine kalija, mokraćne kiseline i kalcijate niske razine fosforau krvi).

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):

kombinacija teškog proširenog osipa, mučnine, vrućice, visoke razine određenih bijelih krvnih

stanica ili žutila kože ili očiju (znakovi žutice) s nedostatkom zraka, bolovima/nelagodom u

prsima, jako smanjenim mokrenjem i žeđi itd. (znakovi alergijske reakcije povezane s

liječenjem).

kronično zatajenje bubrega

ponovna pojava (ponovna aktivacija) infekcije virusom hepatitisa B ako ste u prošlosti

imali

hepatitis B (infekciju jetre).

Ako se kod Vas javi bilo što od gore navedenog, odmah obavijestite svog liječnika.

Druge nuspojave mogu uključivati:

Vrlo česte (mogu se javiti u više od 1 na 10 osoba):

glavobolja ili umor.

mučnina, povraćanje, proljev ili probavne smetnje.

osip.

grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinib Accord

om ili nakon prekida uzimanja Imatinib Accord.

oticanje kao što je oticanje gležnjeva ili otečene oči.

povećanje tjelesne težine.

Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.

Česte (mogu se javiti u do 1 na 10 osoba):

anoreksija, smanjenje tjelesne težine ili poremećaj u osjetu okusa.

omaglica ili slabost.

otežano spavanje (nesanica).

iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid.

krvarenje iz nosa.

bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor.

svrbež.

neuobičajen gubitak ili prorijeđenost kose.

utrnulost šaka ili stopala.

čirevi u ustima.

bolovi u zglobovima s oticanjem.

suha usta, suhoća kože ili suho oko.

smanjena ili povećana osjetljivost kože.

navale vrućine, zimica ili noćno znojenje.

Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.

Nepoznato(učestalost se ne može procijeniti iz dostupnih podataka):

crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim

žarenjem.

usporen rast kod djece i adolescenata.

Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnikaili medicinsku

sestru.To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.Nuspojave možete

prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvatiImatinib Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.

Za PVC/PVdC/Alu blistere

Ne čuvati na temperaturi iznad 30

Za Alu/Alu blistere

Ovaj lijek ne zahtijeva posebne uvjete čuvanja

Ne koristiti pakovanje koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika

kako baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranjai druge informacije

ŠtoImatinib Accordsadrži

Djelatna tvar je imatinibmesilat.

Svaka filmom obložena tableta Imatinib Accorda od 100 mg sadrži 100 mg imatiniba (u obliku

imatinibmesilata).

Svaka filmom obložena tableta Imatinib Accorda od 400 mg sadrži 400 mg imatiniba (u obliku

imatinibmesilata).

Drugi sastojci sumikrokristalična celuloza, krospovidon, hipromeloza 6 cps(E464), magnezijev

stearat i bezvodni koloidni silicijev dioksid.Ovojnica tablete sadrži hipromelozu6 cps (E464), talk

(E553b), polietilenglikol, žuti željezov oksid (E172), crveni željezov oksid (E172).

KakoImatinib Accordizgleda i sadržaj pakiranja

Imatinib Accord100 mg filmom obložene tablete su smećkastonarančaste, okrugle, bikonveksne

filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T1“ s

druge strane razdjelne crte te bez oznaka na drugoj strani tablete.

Imatinib Accord 400 mg filmom obložene tablete su smećkastonarančaste, ovalne, bikonveksne

filmom obložene tablete s utisnutom oznakom „IM“ s jedne strane razdjelne crte i oznakom „T2“ s

druge strane razdjelne crte te bez oznaka na drugoj strani tablete.

Imatinib Accord 100 mg filmom obložene tablete dostupne su u pakovanjima koja sadrže 20, 60, 120

ili 180 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.

Pored toga, Imatinib Accord 100 mg tablete dostupne su u perforiranim blisterima djeljivim na

jedinične doze (PVC/PVdC/Alu) u veličinama pakovanja od 30x1, 60x1, 90x1, 120x1 ili 180x1

filmom obložena tableta.

Imatinib Accord 400 mg filmom obložene tablete dostupne su u pakovanjima koja sadrže 10, 30 ili 90

tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.

Pored toga, Imatinib Accord 400 mg tablete dostupne su u perforiranim blisterima djeljivim na

jedinične doze (PVC/PVdC/Alu) u veličinama pakovanja od 30x1, 60x1ili 90x1 filmom obložena

tableta.

Nositelj odobrenja za stavljanje lijeka u promet

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

Velika Britanija

Proizvođač

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow,

Middlesex, HA1 4HF

Velika Britanija

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estet,

Birzebbugia,BBG 3000, Malta

Ova uputa je zadnji puta revidirana u

Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:

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

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

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

27-6-2018

Glivec (Novartis Europharm Limited)

Glivec (Novartis Europharm Limited)

Glivec (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4087 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/406/T/110

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