Eptifibatide Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Antitrombotska sredstva
  • Područje terapije:
  • Infarkt miokarda
  • Terapijske indikacije:
  • Eptifibatidni sporazum namijenjen je upotrebi s acetilsalicilnom kiselinom i nefrakcioniranim heparinom.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/004104
  • Datum autorizacije:
  • 11-01-2016
  • EMEA koda:
  • EMEA/H/C/004104
  • Zadnje ažuriranje:
  • 27-02-2018

Izvješće o ocjeni javnog

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/785824/2015

EMEA/H/C/004104

EPAR, sažetak za javnost

Eptifibatide Accord

eptifibatid

Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Eptifibatide

Accord. Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te

uvjete za njegovu primjenu. Svrha sažetka nije davati praktične savjete o korištenju lijeka Eptifibatide

Accord.

Praktične informacije o korištenju lijeka Eptifibatide Accord pročitajte u uputi o lijeku, odnosno obratite

se svojem liječniku ili ljekarniku.

Što je Eptifibatide Accord i za što se koristi?

Eptifibatide Accord je lijek koji se koristi za sprečavanje srčanog udara u odraslih. Primjenjuje se u

sljedećim skupinama:

u bolesnika koji imaju nestabilnu anginu (bol u prsima uzrokovana slabim protokom krvi do srca,

koja se može javiti pri mirovanju ili bez nekog očitog uzroka);

u bolesnika koji su već imali infarkt miokarda bez formiranog Q zupca (vrsta srčanog udara), s

bolovima u prsima u posljednja 24 sata i s abnormalnostima na elektrokardiogramu (EKG-u) ili

znakovima srčanih problema u krvi.

Eptifibatide Accord daje se zajedno s aspirinom i nefrakcioniranim heparinom (drugi lijekovi koji

sprečavaju krvne ugruške).

Bolesnici za koje postoji najveća vjerojatnost da će imati koristi od liječenja lijekom Eptifibatide Accord

jesu bolesnici s visokim rizikom od srčanog udara tri do četiri dana nakon početka akutne (iznenadne)

angine. To uključuje bolesnike koji imaju perkutanu transluminalnu koronarnu angiografiju (PTCA,

vrsta operacije kojom se čiste arterije koje opskrbljuju srce).

Lijek sadrži djelatnu tvar eptifibatid.

Eptifibatide Accord

EMA/785824/2015

Stranica 2/3

Eptifibatide Accord je „generički lijek”. To znači da je Eptifibatide Accord sličan „referentnom lijeku” koji

je već odobren u Europskoj uniji (EU) pod nazivom Integrilin. Više informacija o generičkim lijekovima

potražite u dokumentu s pitanjima i odgovorima ovdje.

Kako se Eptifibatide Accord koristi?

Eptifibatide Accord propisuje liječnik s iskustvom u liječenju srčanih udara i angine te se izdaje samo

na liječnički recept. Dostupan je u obliku otopine za infuziju (drip) koja se daje u venu.

Preporučena je doza 180 mikrograma po kilogramu tjelesne težine, koja se daje injekcijom u venu što

prije nakon postavljanja dijagnoze. Nakon toga se daje kontinuirana infuzija od 2,0 mikrograma/kg u

minuti, što se nastavlja do najviše 72 sata, sve do početka operacije srca ili otpuštanja iz bolnice

(ovisno o tome što se prvo dogodi). Ako je bolesnik podvrgnut perkutanoj koronarnoj intervenciji (PCI

ili angioplastika ili kirurški zahvat koji se primjenjuje kako bi se odblokirale sužene koronarne arterije),

infuzija lijeka Eptifibatide Accord može se nastaviti do najviše 24 sata nakon zahvata, pri čemu liječenje

može trajati najdulje 96 sati.

Bolesnicima kojima je umjereno smanjena funkcija rada bubrega trebaju primati manju dozu tijekom

infuzije. Eptifibatide Accord ne smije se primjenjivati u bolesnika s ozbiljnim problemima u funkciji rada

bubrega.

Kako djeluje Eptifibatide Accord?

Eptifibatide Accord je inhibitor agregacije trombocita. To znači da pomaže u sprečavanju sljepljivanja

(agregacije) stanica u krvi koje se nazivaju trombociti. Sljepljivanje trombocita važan je element

stvaranja krvnog ugruška i, ako se dogodi u krvnim žilama koje opskrbljuju srce, može dovesti do

srčanog udara. Djelatna tvar u lijeku Eptifibatide Accord, eptifibatid, zaustavlja sljepljivanje trombocita

blokiranjem proteina glikoprotein IIb/III na njihovoj površini, koji pomaže u njihovu sljepljivanju. To

smanjuje rizik od stvaranja krvnog ugruška i pomaže u sprečavanju srčanih udara.

Kako je Eptifibatide Accord ispitivan?

Tvrtka je pružila podatke iz objavljene literature o eptifibatidu. Nisu bila potrebna dodatna ispitivanja

jer je Eptifibatide Accord generički lijek koji se daje injekcijom i infuzijom u venu i koji sadrži istu

djelatnu tvar kao i referentni lijek Integrilin.

Koje su koristi i rizici lijeka Eptifibatide Accord?

Budući da je Eptifibatide Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni

referentnog lijeka.

Zašto je Eptifibatide Accord odobren?

Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima

EU-a, potvrđeno da je Eptifibatide Accord usporediv s Integrilinom. Stoga je stajalište Odbora da koristi

nadmašuju utvrđene rizike, kao i kod Integrilina. Odbor je preporučio izdavanje odobrenja za primjenu

lijeka Eptifibatide Accord u EU-u.

Eptifibatide Accord

EMA/785824/2015

Stranica 3/3

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Eptifibatide Accord?

Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Eptifibatide

Accord. Na temelju tog plana u sažetak opisa svojstava lijeka i uputu o lijeku za Eptifibatide Accord

uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni

djelatnici i bolesnici trebaju pridržavati.

Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom

Ostale informacije o lijeku Eptifibatide Accord

Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) i sažetak plana upravljanja

rizikom za Eptifibatide Accord nalaze se na internetskim stranicama Agencije:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. Više informacija o terapiji lijekom

Eptifibatide Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku

ili ljekarniku.

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

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za bolesnika

Eptifibatid Accord 0,75 mg/ml otopina za infuziju

eptifibatid

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

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj

sestri.

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

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

Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Eptifibatid Accord i za što se koristi

Što morate znati prije nego počnete primati Eptifibatid Accord

Kako primjenjivati Eptifibatid Accord

Moguće nuspojave

Kako čuvati Eptifibatid Accord

Sadržaj pakiranja i druge informacije

1.

Što je Eptifibatid Accord i za što se koristi

Eptifibatid Accord je inhibitor agregacije trombocita. To znači da pomaže u sprječavanju nastanka

krvnih ugrušaka.

Koristi se u bolesnika s teškom koronarnom insuficijencijom, koja se definira kao spontana i nedavna

bol u prsima s elektrokardiografskim abnormalnostima ili biološkim promjenama. Obično se

primjenjuje zajedno s aspirinom i nefrakcioniranim heparinom.

2.

Što morate znati prije nego počnete primati Eptifibatid Accord

Nemojte primjenjivati Eptifibatid Accord:

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

ako ste nedavno imali krvarenje iz želuca, crijeva, mokraćnog mjehura ili drugih organa, na

primjer ako ste uočili abnormalnu pojavu krvi u stolici ili mokraći (osim menstrualnog

krvarenja) u proteklih 30 dana.

ako ste u proteklih 30 dana doživjeli moždani udar ili bilo koju drugu vrstu izljeva krvi u mozak

(također, liječnik svakako mora znati ako ste ikada doživjeli moždani udar).

ako ste imali tumor na mozgu ili stanje koje utječe na krvne žile oko mozga.

ako ste imali veliki operativni zahvat ili tešku ozljedu tijekom proteklih 6 tjedana.

ako ste imali ili imate problema s krvarenjima.

ako ste imali ili imate problema s zgrušavanjem krvi ili nizak broj trombocita.

ako ste imali ili imate tešku hipertenziju (visoki krvni tlak).

ako ste imali ili imate ozbiljnih problema s bubrezima ili jetrom.

ako ste bili liječeni nekim drugim lijekom istog djelovanja kao Eptifibatid Accord.

Recite svom liječniku ako ste imali ili imate bilo koje od ovih stanja. Ako imate nekih pitanja, pitajte

svog liječnika, bolničkog ljekarnika ili medicinsku sestru.

Upozorenja i mjere opreza:

Eptifibatid Accord se preporučuje za primjenu jedino u odraslih bolesnika, koji se nalaze u

bolnici u koronarnim jedinicama.

Eptifibatid Accord nije namijenjen za primjenu u djece ili adolescenata mlađih od 18 godina.

Prije i tijekom liječenja s Eptifibatid Accordom, kao mjera sigurnosti služi provjera uzoraka Vaše krvi,

kako bi se smanjila mogućnost neočekivanog krvarenja.

Tijekom primjene Eptifibatid Accorda, posebna pažnja bit će usmjerena uočavanju bilo kakvih

znakova neuobičajenog i neočekivanog krvarenja.

Obratite se svom liječniku ili bolničkom ljekarniku ili medicinskoj sestri prije nego primijenite

Eptifibatid Accord.

Drugi lijekovi i Eptifibatid Accord

Kako biste izbjegli mogućnost pojave interakcije obavijestite svog liječnika,bolničkog ljekarnika ili

medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove,

uključujući i one koje ste nabavili bez recepta. Naročito:oralne antikoagulanse (lijekove za

sprječavanje zgrušavanja krvi) ili lijekove koje sprječavaju nastanak krvnih ugrušaka, uključujući

varfarin, dipiridamol, tiklopidin, aspirin (osim onih koje Vam liječnik može dati kao dio liječenja

Eptifibatid Accordom).

Trudnoća i dojenje

Primjena Eptifibatid Accorda u trudnoći se obično ne preporučuje. Ako ste trudni, mislite da biste

mogli biti trudni ili planirate imati dijete, obratite se svom liječniku. Vaš će liječnik procijeniti korist

primjene Eptifibatid Accorda za Vas i rizik za Vaš plod tijekom trudnoće.

Ako dojite, potrebno je prekinuti dojenje tijekom perioda liječenja.

3.

Kako primjenjivati Eptifibatid Accord

Eptifibatid Accord se daje u venu direktnom injekcijom nakon koje slijedi infuzija (drip otopina).

Doza lijeka se određuje prema Vašoj tjelesnoj težini. Preporučena doza iznosi 180 mikrograma/kg

primijenjena u bolusu (brza intravenska injekcija), nakon koje slijedi infuzija (drip otopina) u dozi od

2 mikrograma/kg/minuti u trajanju do 72 sata. Ako bolujete od neke bolesti bubrega, infuzijska doza

može se smanjiti na 1 mikrogram/kg/minuti.

Ako se tijekom liječenja Eptifibatid Accordom provede perkutana koronarna intervencija (PCI),

infuzija intravenske otopine može se nastaviti davati i do 96 sati.

Također morate uzimati aspirin i heparin (ako nisu kontraindicirani u Vašem slučaju).

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, bolničkom

ljekarniku ili medicinskoj sestri.

4.

Moguće nuspojave

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

Vrlo česte nuspojave

Mogu se javiti u više od 1 na 10 osoba

manja ili velika krvarenja (npr. krv u mokraći, krv u stolici, krv u povraćenom sadržaju ili

krvarenje pri kirurškom zahvatu).

anemija (smanjeni broj crvenih krvnih stanica).

Česte nuspojave

Mogu se javiti u do 1 na 10 osoba

upala vene.

Manje česte nuspojave

Mogu se javiti u do 1 na 100 osoba

smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).

smanjeni dotok krvi u mozak.

Vrlo rijetke nuspojave

Mogu se javiti u do 1 na 10000 osoba

ozbiljno krvarenje (na primjer krvarenje u trbušnoj šupljini, u mozgu i u pluća).

krvarenje sa smrtnim ishodom.

ozbiljno smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).

osip kože (kao što je koprivnjača).

iznenadna, teška alergijska reakcija.

Ako primijetite bilo kakav znak krvarenja, odmah obavijestite svog liječnika ili bolničkog ljekarnika

ili medicinsku sestru. Vrlo rijetko, krvarenje može postati jako ili završiti smrću. Mjere sigurnosti koje

se poduzimaju kako bi se ovo sprječilo uključuju pretrage krvi i pažljiv nadzor zdravstvenih radnika

koji brinu o Vama.

Ako nastupi jaka alergijska reakcija ili koprivnjača, odmah o tome obavijestite svog liječnika,

bolničkog ljekarnika ili medicinsku sestru.

Drugi događaji koji mogu nastupiti u bolesnika koji zahtijevaju ovu vrstu terapije uključuju one koji

su povezani sa stanjima koja se liječe, kao što su brz ili nepravilan rad srca, niski krvni tlak, šok ili

zastoj rada srca.

Prijavljivanje nuspojava

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

sestru. Ovo 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 čuvati Eptifibatid Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti koji je naveden na kutiji i bočici iza

oznake Rok valjanosti i EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati u hladnjaku (2

C – 8

Bočicu čuvati u originalnom pakiranju radi zaštite od svjetlosti. Zaštita otopine Eptifibatid Accorda od

svjetlosti nije potrebna tijekom primjene.

Prije primjene, sadržaj bočice treba pregledati.

Eptifibatid Accord se ne smije upotrijebiti ako primijetite čestice ili promjenu boje otopine.

Nakon otvaranja, neupotrijebljeni lijek treba odbaciti.

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

ljekarnika kako baciti lijekove koje više ne koristite.

6.

Sadržaj pakiranja i druge informacije

Što Eptifibatid Accord sadrži

Djelatna tvar je eptifibatid.

Eptifibatid Accord 0,75 mg/ml

: jedan ml otopine za infuziju sadržava 0,75 mg eptifibatida.

Jedna bočica sa 100 ml otopine za infuziju sadržava 75 mg eptifibatida.

Drugi sastojci su citratna kiselina hidrat, natrijev hidroksid i voda za injekcije.

Kako Eptifibatid Accord izgleda i sadržaj pakiranja

Eptifibatid Accord 0,75 mg/ml otopina za infuziju: bočica sa 100 ml, kutija s jednom bočicom.

Eptifibatid Accord 0,75 mg/ml:

bistra bezbojna otopina u staklenoj bočici od 100 ml, zatvorenoj s

gumenim čepom (butil guma) i aluminijskim „flip-off“ zaštitnim poklopcem.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet:

Accord Healthcare Limited

Sage House

319, Pinner Road, North Harrow

Middlesex HA1 4HF

Ujedinjeno Kraljvstvo

Proizvođač:

Accord Healthcare Limited

Sage House

319, Pinner Road, Harrow

Middlesex HA1 4HF

Ujedinjeno Kraljevstvo

Wessling Hungary Kft

Fòti ùt 56, Budapest 1047,

Mađarska

Ova uputa je zadnji puta revidirana u <{MM/GGGG}>.

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

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

Uputa o lijeku: Informacije za bolesnika

Eptifibatid Accord 2 mg/m lotopina za injekciju

eptifibatid

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

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku, bolničkom ljekarniku ili medicinskoj

sestri.

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

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

Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Eptifibatid Accord i za što se koristi

Što morate znati prije nego počnete primjati Eptifibatid Accord

Kako primjenjivati Eptifibatid Accord

Moguće nuspojave

Kako čuvati Eptifibatid Accord

Sadržaj pakiranja i druge informacije.

1.

Što je Eptifibatid Accord i za što se koristi

Eptifibatid Accord je inhibitor agregacije trombocita. To znači da pomaže u sprječavanju nastanka

krvnih ugrušaka.

Koristi se u bolesnika s teškom koronarnom insuficijencijom, koja se definira kao spontana i nedavna

bol u prsima s elektrokardiografskim abnormalnostima ili biološkim promjenama. Obično se

primjenjuje zajedno s aspirinom i nefrakcioniranim heparinom.

2.

Što morate znati prije nego počnete primati Eptifibatid Accord

Nemojte primjenjivati Eptifibatid Accord:

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

ako ste nedavno imali krvarenje iz želuca, crijeva, mokraćnog mjehura ili drugih organa, na

primjer ako ste uočili abnormalnu pojavu krvi u stolici ili mokraći (osim menstrualnog

krvarenja) u proteklih 30 dana

ako ste u proteklih 30 dana doživjeli moždani udar ili bilo koju drugu vrstu izljeva krvi u mozak

(također, liječnik svakako mora znati ako ste ikada doživjeli moždani udar)

ako ste imali tumor na mozgu ili stanje koje utječe na krvne žile oko mozga

ako ste imali veliki operativni zahvat ili tešku ozljedu tijekom proteklih 6 tjedana

ako ste imali ili imate problema s krvarenjima

ako ste imali ili imate problema s zgrušavanjem krvi ili nizak broj trombocita

ako ste imali ili imate tešku hipertenziju (visoki krvni tlak)

ako ste imali ili imate ozbiljnih problema s bubrezima ili jetrom

ako ste bili liječeni nekim drugim lijekom istog djelovanja kao Eptifibatid Accord.

Recite svom liječniku ako ste imali ili imate bilo koje od ovih stanja. Ako imate nekih pitanja, pitajte

svog liječnika, bolničkog ljekarnika ili medicinsku sestru.

Upozorenja i mjere opreza:

Eptifibatid Accord se preporučuje za primjenu jedino u odraslih bolesnika, koji se nalaze u

koronarnim jedinicama.

Eptifibatid Accord nije namijenjen za primjenu u djece ili adolescenata mlađih od 18 godina.

Prije i tijekom liječenja s Eptifibatid Accordom, kao mjera sigurnosti služi provjera uzoraka Vaše

krvi, kako bi se smanjila mogućnost neočekivanog krvarenja.

Tijekom primjene Eptifibatid Accorda, posebna pažnja bit će usmjerena uočavanju bilo kakvih

znakova neuobičajenog i neočekivanog krvarenja.

Obratite se svom liječniku ili bolničkom ljekarniku ili medicinskoj sestri prije nego primijenite

Eptifibatid Accord.

Drugi lijekovi i Eptifibatid Accord

Obavijestite svog liječnika ili bolničkog ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli

uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta. Naročito: oralne

antikoagulanse (lijekove za sprječavanje zgrušavanja krvi) ili lijekove koje sprječavaju nastanak

krvnih ugrušaka, uključujući varfarin, dipiridamol, tiklopidin, aspirin (osim onih koje Vam liječnik

može dati kao dio liječenja Eptifibatid Accordom).

Trudnoća i dojenje

Primjena Eptifibatid Accorda u trudnoći se obično ne preporučuje. Ako ste trudni, mislite da biste

mogli biti trudni ili planirate imati dijete, obratite se svom liječniku. Vaš će liječnik procijeniti korist

primjene Eptifibatid Accorda za Vas i rizik za Vaš plod tijekom trudnoće.

Ako dojite, potrebno je prekinuti dojenje tijekom perioda liječenja.

3.

Kako primjenjivati Eptifibatid Accord

Eptifibatid Accord se daje u venu direktnom injekcijom nakon koje slijedi infuzija (drip otopina).

Doza lijeka se određuje prema Vašoj tjelesnoj težini. Preporučena doza iznosi 180 mikrograma/kg

primijenjena u bolusu (brza intravenska injekcija), nakon koje slijedi infuzija (drip otopina) u dozi od

2 mikrograma/kg/minuti u trajanju do 72 sata. Ako bolujete od neke bolesti bubrega, infuzijska doza

može se smanjiti na 1 mikrogram/kg/minuti.

Ako se tijekom liječenja Eptifibatid Accordom provede perkutana koronarna intervencija (PCI),

infuzija intravenske otopine može se nastaviti davati i do 96 sati.

Također morate uzimati aspirin i heparin (ako nisu kontraindicirani u Vašem slučaju).

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, bolničkom

ljekarniku ili medicinskoj sestri.

4.

Moguće nuspojave

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

Vrlo česte nuspojave

Mogu se javiti u više od 1 na 10 osoba

manja ili velika krvarenja (npr. krv u mokraći, krv u stolici, krv u povraćenom sadržaju ili

krvarenje pri kirurškom zahvatu).

anemija (smanjeni broj crvenih krvnih stanica).

Česte nuspojave

Mogu se javiti u do 1 na 10 osoba

upala vene.

Manje česte nuspojave

Mogu se javiti u do 1 na 100 osoba

smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).

smanjeni dotok krvi u mozak.

Vrlo rijetke nuspojave

Mogu se javiti u dood 1 na 10000 osoba

ozbiljno krvarenje (na primjer krvarenje u trbušnoj šupljini, u mozgu i u pluća).

krvarenje sa smrtnim ishodom.

ozbiljno smanjenje broja trombocita (krvnih stanica neophodnih za zgrušavanje krvi).

osip kože (kao što je koprivnjača).

iznenadna, teška alergijska reakcija.

Ako primijetite bilo kakav znak krvarenja, odmah obavijestite svog liječnika, bolničkog ljekarnika ili

medicinsku sestru. Vrlo rijetko, krvarenje može postati jako ili završiti smrću. Mjere sigurnosti koje se

poduzimaju kako bi se ovo sprječilo uključuju pretrage krvi i pažljiv nadzor zdravstvenih radnika koji

brinu o Vama.

Ako nastupi jaka alergijska reakcija ili koprivnjača, odmah o tome obavijestite svog liječnika,

bolničkog ljekarnika ili medicinsku sestru.

Drugi događaji koji mogu nastupiti u bolesnika koji zahtijevaju ovu vrstu terapije uključuju one koji

su povezani sa stanjima koja se liječe, kao što su brz ili nepravilan rad srca, niski krvni tlak, šok ili

zastoj rada srca.

Prijavljivanje nuspojava

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

sestru. Ovo 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 čuvati Eptifibatid Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti koji je naveden na kutiji i bočici iza

oznake Rok valjanosti i EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati u hladnjaku (2 C–8

Bočicu čuvati u originalnom pakiranju radi zaštite od svjetlosti. Zaštita otopine Eptifibatid Accorda od

svjetlosti nije potrebna tijekom primjene.

Prije primjene, sadržaj bočice treba pregledati.

Eptifibatid Accord se ne smije upotrijebiti ako primijetite čestice ili promjenu boje otopine.

Nakon otvaranja, neupotrijebljeni lijek treba odbaciti.

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

ljekarnika kako baciti lijekove koje više ne koristite.

6.

Sadržaj pakiranja i druge informacije

Što Eptifibatid Accord sadrži

Djelatna tvar je eptifibatid.

Eptifibatid Accord 2mg/ml

: jedan ml otopine za injekciju sadrži 2 mg eptifibatida. Jedna

bočica sa 10 ml otopine za injekciju sadržava 20 mg eptifibatida.

Drugi sastojci su citratna kiselina hidrat, natrijev hidroksid i voda za injekcije.

Kako Eptifibatid Accord izgleda i sadržaj pakiranja

Eptifibatid Accord 2 mg/ml otopina za injekciju: bočica s 10 ml, kutija s jednom bočicom.

Eptifibatid Accord 2 mg/ml:

bistra bezbojna otopina u staklenoj bočici od 10 ml, zatvorenoj s

gumenim čepom (butil guma) i aluminijskim „flip-off“ zaštitnim poklopcem.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja za stavljanje lijeka u promet:

Accord Healthcare Limited

Sage House

319, Pinner Road, North Harrow

Middlesex HA1 4HF

Ujedinjeno Kraljvstvo

Proizvođač:

Accord Healthcare Limited

Sage House

319, Pinner Road, Harrow

Middlesex HA1 4HF

Ujedinjeno Kraljvstvo

Wessling Hungary Kft

Fòti ùt 56, Budapest 1047,

Mađarska

Ova uputa je zadnji puta revidirana u

<{MM/GGGG}>.

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

lijekove:

http://www.ema.europa.eu

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

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

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety