Voriconazole Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • vorikonazol
  • Područje terapije:
  • aspergiloza
  • Terapijske indikacije:
  • Vorikonazol je širokog spektra, triazola antifungalna agent i indicirana je u odraslih i djece u dobi od dvije godine i iznad kako slijedi:.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002669
  • Datum autorizacije:
  • 16-05-2013
  • EMEA koda:
  • EMEA/H/C/002669
  • Zadnje ažuriranje:
  • 05-03-2018

Izvješće o ocjeni javnog

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

EMA/831772/2015

EMEA/H/C/002669

EPAR, sažetak za javnost

Voriconazole Accord

vorikonazol

Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Voriconazole

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

Voriconazole Accord.

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

obratite se svom liječniku ili ljekarniku.

Što je Voriconazole Accord i za što se koristi?

Voriconazole Accord je antifungalni lijek koji sadrži djelatnu tvar vorikonazol. Primjenjuje se za

liječenje odraslih i djece starije od dvije godine s:

invazivnom aspergilozom (vrstom gljivične infekcije uzrokovane gljivicom Aspergillus);

kandidemijom (vrstom gljivične infekcije uzrokovane gljivicom Candida) u bolesnika koji nemaju

neutropeniju (bolesnika s normalnim brojem bijelih krvnih stanica);

teškim invazivnim infekcijama uzrokovanima gljivicom Candida u slučaju kada je gljivica

rezistentna na flukonazol (drugi antifungalni lijek);

teškim gljivičnim infekcijama uzrokovanima vrstama iz rodova Scedosporium ili Fusarium (dvije

različite vrste gljivica).

Kada se primjenjuje za liječenje gljivičnih infekcija, Voriconazole Accord je uglavnom namijenjen

bolesnicima s gljivičnim infekcijama koje se pogoršavaju, a mogu biti opasne po život.

Voriconazole Accord se također primjenjuje za prevenciju gljivičnih infekcija u primatelja

hematopoetske transplantacije (krvnih) matičnih stanica (transplantacije vrste matičnih stanica koje se

mogu razviti u krvne stanice) s visokim rizikom od infekcije.

Voriconazole Accord

EMA/831772/2015

Stranica 2/3

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

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

potražite u dokumentu s pitanjima i odgovorima ovdje.

Kako se Voriconazole Accord koristi?

Lijek Voriconazole Accord dostupan je u obliku tableta (50 ili 200 mg). Uzima se dvaput na dan. Doza

lijeka Voriconazole Accord ovisi o tjelesnoj težini bolesnika. Bolesnici moraju primiti početnu veću dozu

(udarnu dozu) prvoga dana liječenja. Udarna se doza daje radi brzog postizanja učinkovitih razina

koncentracije u krvi. Nakon udarne doze daje se doza održavanja koja se može prilagoditi sukladno

tome kako bolesnik podnosi lijek. Doza se može povećati ili smanjiti ovisno o tome kako bolesnik

podnosi lijek.

Tablete se uzimaju najmanje jedan sat prije ili poslije obroka. Za dodatne informacije vidjeti uputu o

lijeku. Ovaj se lijek izdaje samo na liječnički recept.

Kako djeluje Voriconazole Accord?

Djelatna tvar u lijeku Voriconazole Accord, vorikonazol, antifungalni je lijek koji se ubraja u skupinu

„triazola”. Djeluje tako da sprečava stvaranje ergosterola koji je važan sastavni dio stanične stijenke

gljivica. Bez ergosterola, gljivica umire ili je onemogućeno njezino širenje. Popis gljivica protiv kojih je

Voriconazole Accord aktivan dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).

Kako je Voriconazole Accord ispitivan?

Budući da je lijek Voriconazole Accord generički lijek, ispitivanja na bolesnicima bila su ograničena na

ispitivanja za utvrđivanje bioekvivalentnosti s referentnim lijekom Vfend. Dva su lijeka bioekvivalentna

kada u tijelu proizvode iste razine djelatne tvari.

Koje su koristi i rizici lijeka Voriconazole Accord?

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

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

Zašto je Voriconazole Accord odobren?

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

EU-a, potvrđeno da Voriconazole Accord posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom

Vfend. Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Vfend. Odbor je

preporučio izdavanje odobrenja za primjenu lijeka Voriconazole Accord u EU-u.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Voriconazole Accord?

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

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

nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici

i bolesnici trebaju pridržavati.

Voriconazole Accord

EMA/831772/2015

Stranica 3/3

Ostale informacije o lijeku Voriconazole Accord

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

snazi u Europskoj uniji od 16. svibnja 2013.

Cjeloviti EPAR za Voriconazole Accord nalazi se na internetskim stranicama Agencije:

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

o terapiji lijekom Voriconazole Accord pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite

svom liječniku ili ljekarniku.

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

Ovaj sažetak je posljednji put ažuriran u prosincu 2015.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za korisnika

Voriconazole Accord 50 mg filmom obložene tablete

Voriconazole Accord 200 mg filmom obložene tablete

vorikonazol

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 je Voriconazole Accord i za što se koristi

Što morate znati prije nego počnete uzimati Voriconazole Accord

Kako uzimati Voriconazole Accord

Moguće nuspojave

Kako čuvati Voriconazole Accord

Sadržaj pakiranja i druge informacije

1.

Što je Voriconazole Accord i za što se koristi

Voriconazole Accord sadrži djelatnu tvar vorikonazol. Voriconazole Accord je antimikotik. Djeluje

tako da uništava ili zaustavlja rast gljivica koje uzrokuju infekcije.

Koristi se za liječenje bolesnika (odraslih i djece starije od 2 godine) koji imaju:

invazivnu aspergilozu (vrstu gljivične infekcije uzrokovanu vrstama iz roda

Aspergillus

kandidemiju (drugu vrstu gljivične infekcije uzrokovanu vrstama iz roda

Candida

) u bolesnika

bez neutropenije (bolesnika bez abnormalno sniženog broja bijelih krvih stanica),

teške invazivne infekcije uzrokovane vrstama iz roda

Candida

kada je gljivica otporna na

flukonazol (drugi antifungalni lijek),

teške gljivične infekcije uzrokovane vrstama iz rodova

Scedosporium

Fusarium

(dva različita

tipa gljivica).

Voriconazole Accord je namijenjen bolesnicima s gljivičnim infekcijama koje se pogoršavaju, a mogu

biti opasne po život.

Prevencija gljivičnih infekcija u visokorizičnih primatelja transplantacije koštane srži.

Ovaj se lijek smije uzimati samo pod nadzorom liječnika.

2.

Što morate znati prije nego počnete uzimati Voriconazole Accord

Nemojte uzimati Voriconazole Accord

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

Vrlo je važno da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke

druge lijekove, uključujući i one koje ste nabavili bez recepta ili biljne lijekove.

Lijekovi navedeni u sljedećem popisu ne smiju se uzimati za vrijeme liječenja lijekom Voriconazole

Accord:

terfenadin (koristi se za liječenje alergija)

astemizol (koristi se za liječenje alergija)

cisaprid (koristi se za ublažavanje želučanih tegoba)

pimozid (koristi se za liječenje duševnih bolesti)

kinidin (koristi se za liječenje nepravilnih otkucaja srca)

rifampicin (koristi se za liječenje tuberkuloze)

efavirenz (koristi se za liječenje HIV-a) u dozi od 400 mg i više jednom na dan

karbamazepin (koristi se za liječenje epileptičkih napadaja)

fenobarbital (koristi se kod teške nesanice i epileptičkih napadaja)

ergot alkaloidi (npr. ergotamin, dihidroergotamin; koriste se za liječenje migrene)

sirolimus (koristi se u bolesnika s presatkom organa)

ritonavir (koristi se za liječenje HIV-a) u dozama od 400 mg i više dva puta na dan

gospina trava (biljni pripravak)

Upozorenja i mjere opreza

Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Voriconazole Accord:

ako ste imali alergijsku reakciju na druge azole.

ako sada bolujete ili ste ikada imali bolest jetre. Ako imate bolest jetre, liječnik će Vam možda

propisati nižu dozu lijeka Voriconazole Accord. Za vrijeme liječenja lijekom Voriconazole

Accord liječnik također mora pratiti funkciju Vaše jetre putem krvnih pretraga.

ako se zna da imate kardiomiopatiju, nepravilane otkucaje srca, usporene otkucaje srca ili

nepravilnost u elektrokardiogramu (EKG) koja se naziva „sindrom produljenog QTc-intervala“.

Tijekom liječenja morate izbjegavati sunčevu svjetlost i izlaganje suncu. Važno je da pokrijete

područja kože izložena suncu i koristite sredstvo za zaštitu od sunca s visokim zaštitnim faktorom

(SPF) jer može doći do pojačane osjetljivosti kože na sunčeve UV zrake. Ove mjere opreza vrijede

također i za djecu.

Za vrijeme liječenja lijekom Voriconazole Accord:

odmah recite svom liječniku ako dobijete

opekline od sunca

teški osip ili mjehuriće po koži

bolove u kostima

Ako dobijete poremećaje kože opisane u prethodnom tekstu, Vaš liječnik Vas može uputiti

dermatologu, koji nakon konzultacija može odlučiti da je važno da redovito dolazite na kontrole.

Postoji mala šansa od razvoja karcinoma kože uz dugoročnu primjenu lijeka Voriconazole Accord.

Vaš liječnik Vam mora pratiti funkciju Vaše jetre i bubrega putem krvnih pretraga.

Djeca i adolescenti

Voriconazole Accord se ne smije davati djeci mlađoj od 2 godine.

Drugi lijekovi i Voriconazole Accord

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

druge lijekove, uključujući i one koje ste nabavili bez recepta.

Kada se primjenjuju istodobno s lijekom Voriconazole Accord, neki lijekovi mogu utjecati na

djelovanje lijeka Voriconazole Accord, ali i Voriconazole Accord može utjecati na djelovanje drugih

lijekova.

Obavijestite svog liječnika ako uzimate sljedeći lijek, jer treba izbjegavati istodobno liječenje lijekom

Voriconazole Accord ako je to moguće:

ritonavir (koristi se za liječenje HIV-a) u dozi od 100 mg dva puta na dan.

Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova jer treba izbjegavati istodobno

liječenje lijekom Voriconazole Accord, a možda će biti potrebno i prilagoditi dozu vorikonazola:

rifabutin (koristi se za liječenje tuberkuloze). Ako već primate rifabutin, morat će se kontrolirati

krvna slika i pratiti moguća pojava nuspojave na rifabutin.

fenitoin (koristi se za liječenje epilepsije). Ako već primate fenitoin, za vrijeme liječenja

lijekom Voriconazole Accord morat će se pratiti koncentracija fenitoina u krvi i možda

prilagoditi doza lijeka.

Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova, jer će možda trebati prilagoditi

dozu lijeka ili provjeravati imaju li oni i/ili Voriconazole Accord i dalje željeni učinak:

varfarin i ostale antikoagulanse (npr. fenprokumon, acenokumarol; primjenjuju se za

usporavanje zgrušavanja krvi)

ciklosporin (koristi se u bolesnika s presatkom organa)

takrolimus (koristi se u bolesnika s presatkom organa)

sulfonilureje (tj. tolbutamid, glipizid, i gliburid) (koriste se za liječenje šećerne bolesti)

statine (npr. atorvastatin, simvastatin) (koriste se za snižavanje razine kolesterola)

benzodiazepine (npr. midazolam, triazolam) (koriste se kod teške nesanice i stresa)

omeprazol (koristi se za liječenje vrijeda)

oralne kontraceptive (ako uzimate Voriconazole Accord istodobno s oralnim kontraceptivima,

možete imati nuspojave poput mučnine i poremećaja menstruacije)

vinka alkaloide (npr. vinkristin i vinblastin) (koriste se za liječenje raka)

indinavir i druge inhibitore HIV proteaze (koriste se za liječenje HIV-a)

nenukleozidne inhibitore reverzne transkriptaze (npr. efavirenz, delavirdin, nevirapin) (koriste

se za liječenje HIV-a) (neke doze efavizina se NE SMIJU uzimati istovremeno s lijekom

Voriconazole Accord)

metadon (koristi se za liječenje ovisnosti o heroinu)

alfentanil, fentanil i ostale opijate kratkog djelovanja, kao što je sufentanil (lijekovi protiv

bolova koji se koriste kod kirurških zahvata)

oksikodon i ostale opijate dugog djelovanja, kao što je hidrokodon (koriste se za ublažavanje

umjerene do jake boli)

nesteroidne protuupalne lijekove (npr. ibuprofen, diklofenak) (koriste se za liječenje boli i

upale)

flukonazol (koristi se za liječenje gljivičnih infekcija)

everolimus (koristi se za liječenje uznapredovalog raka bubrega i u bolesnika s presatkom

organa)

Trudnoća i dojenje

Voriconazole Accord se ne smije uzimati tijekom trudnoće osim ako Vaš liječnik nije tako odlučio.

Žene reproduktivne dobi trebaju koristiti učinkovitu kontracepciju. Odmah se javite svom liječniku

ako zatrudnite za vrijeme uzimanja lijeka Voriconazole Accord.

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Voriconazole Accord može uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost. Ako to

osjećate, nemojte voziti niti rukovati alatima ili strojevima. Javite se svom liječniku ako imate te

nuspojave.

Voriconazole Accord sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja lijeka

Voriconazole Accord.

3.

Kako uzimati Voriconazole Accord

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite s liječnikom ili

ljekarnikom ako niste sigurni.

Liječnik će odrediti dozu lijeka ovisno o Vašoj tjelesnoj težini i vrsti infekcije koju imate.

Preporučena doza za odrasle (uključujući starije bolesnike) je kako slijedi:

Tablete

Bolesnici tjelesne težine

40 kg i više

Bolesnici tjelesne težine

manje od 40 kg

Doza tijekom prva 24

sata

(udarna doza)

400 mg svakih 12 sati

tijekom prva 24 sata

200 mg svakih 12 sati

tijekom prva 24 sata

Doza nakon prva 24 sata

(doza održavanja)

200 mg dvaput na dan

100 mg dvaput na dan

Ovisno o Vašem odgovoru na liječenje, liječnik može povećati dnevnu dozu na 300 mg dva puta na

dan.

Liječnik će možda odlučiti smanjiti dozu ako imate blagu do umjerenu cirozu jetre.

Primjena u djece i adolescenata

Preporučena doza za djecu i adolescente je kako slijedi:

Tablete

Djeca u dobi od 2 do nepunih

12 godina i adolescenti od 12

do 14 godina koji imaju

manje od 50 kg

Adolescenti od 12 do 14

godina koji imaju 50 kg i

više; i svi adolescenti

stariji od 14 godina

Doza tijekom prva 24

sata

(udarna doza)

Liječenje će započeti

infuzijom

400 mg svakih 12 sati

tijekom prva 24 sata

Doza nakon prva 24 sata

(doza održavanja)

9 mg/kg dvaput na dan

(najviša doza je 350 mg

dvaput na dan)

200 mg dvaput na dan

Ovisno o Vašem odgovoru na liječenje, liječnik može povećati ili smanjiti dnevnu dozu.

Tablete se smiju davati samo ako ih dijete može progutati.

Tablete uzimajte najmanje jedan sat prije ili jedan sat nakon jela. Progutajte cijelu tabletu s malo vode.

Ako Vi ili Vaše dijete uzimate Voriconazole Accord za prevenciju gljivičnih infekcija, liječnik

Vam može prestati davati Voriconazole Accord ako Vi ili Vaše dijete razvijete nuspojave povezane

s liječenjem.

Ako uzmete više lijeka Voriconazole Accord nego što ste trebali

Ako uzmete više tableta nego Vam je propisano (ili ako netko drugi uzme Vaše tablete), morate

odmah zatražiti savjet liječnika ili otići u hitnu službu najbliže bolnice. Ponesite sa sobom kutiju lijeka

Voriconazole Accord. Možete osjetiti neuobičajeno nepodnošenje svjetlosti kao posljedicu uzimanja

prevelike količine lijeka Voriconazole Accord.

Ako ste zaboravili uzeti Voriconazole Accord

Važno je da Voriconazole Accord tablete uzimate redovito, svakog dana u isto vrijeme. Ako

zaboravite uzeti jednu dozu, uzmite sljedeću dozu u predviđeno vrijeme. Nemojte uzeti dvostruku

dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Voriconazole Accord

Pokazalo se da se djelotvornost Vašeg lijeka može znatno povećati ako sve doze uzimate redovito i u

predviđeno vrijeme. Stoga je, ako Vam liječnik nije rekao da prekinete liječenje, važno da

Voriconazole Accord uzimate na pravilan način, kako je prethodno opisano.

Nastavite uzimati Voriconazole Accord sve dok Vam liječnik ne kaže da prestanete. Nemojte prerano

prestati s liječenjem jer infekcija možda neće biti izliječena. Bolesnicima s oslabljenim imunološkim

sustavom ili onima s teškim infekcijama možda će biti potrebno dulje liječenje kako bi se spriječio

povratak infekcije.

Kada liječnik odredi prekid liječenja lijekom Voriconazole Accord, ne biste trebali imati nikakvih

nuspojava.

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

medicinskoj sestri

.

4.

Moguće nuspojave

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

Pojave li se nuspojave, one će u većini slučajeva biti blage i prolazne. Međutim, neke od njih mogu

biti ozbiljne te zahtijevati liječničku pomoć.

Ozbiljne nuspojave - prestanite uzimati Voriconazole Accord i odmah se javite liječniku

osip

žutica; promjene jetrenih funkcija u krvnim pretragama

pankreatitis (upala gušterače).

Druge nuspojave

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

oštećenje vida (promjene vida koje uključuju zamagljeni vid, izmjene doživljaja boja,

neuobičajeno nepodnošenje vizualnog doživljaja svjetlosti, sljepoću za boje, poremećaje oka,

aureole oko izvora svjetlosti, noćnu sljepoću, ljuljajuću sliku, iskrenje pred očima, vizualnu

auru, smanjenu oštrinu vida, vizualnu svjetlinu, gubitak dijela uobičajenog vidnog polja, točke

pred očima)

vrućica

osip

mučnina, povraćanje, proljev

glavobolja

oticanje udova

bolovi u trbuhu

otežano disanje

povišeni jetreni enzimi

Česte: mogu se javiti u do 1 na 10 osoba

upala sinusa, upala desni, zimica, slabost

smanjen (uključujući i značajno smanjen) broj nekih vrsta crvenih (katkad povezano s

imunitetom) i/ili bijelih krvnih stanica (katkad popraćeno temperaturom), niski broj stanica koje

se nazivaju trombociti i koje pomažu u zgrušavanju krvi

nizak šećer u krvi, nizak kalij u krvi, nizak natrij u krvi

tjeskoba, depresija, smetenost, uznemirenost, nemogućnost spavanja, halucinacije

napadaji, nevoljno drhtanje ili nekontrolirani pokreti mišića, trnci ili neuobičajen osjet na koži,

povećana napetost mišića, pospanost, omaglica

krvarenje u oku

problemi sa srčanim ritmom uključujući vrlo brze otkucaje srca, vrlo spore otkucaje srca,

nesvjestica, nizak krvni tlak, upala vene (može biti povezana sa stvaranjem krvnog ugruška)

akutno otežano disanje, bol u prsima, oticanje lica (usne šupljine, usana i oko očiju),

nakupljanje tekućine u plućima

zatvor, probavne tegobe, upala usana

žutica, upala jetre i oštećenje jetre

kožni osipi koji mogu dovesti do jakog stvaranja mjehurića i ljuštenja kože karakterizirani

ravnim, crvenim područjem kože koje je prekriveno malim izraslinama koje se spajaju, crvenilo

kože

svrbež

gubitak kose

bol u leđima

zatajenje bubrega, krv u mokraći, promjene u testovima funkcije bubrega

Manje česte: mogu se javiti u do 1 na 100 osoba

simptomi nalik gripi, nadraženost i upala probavnog trakta, upala probavnog sustava koja

uzrokuje proljev povezan s antibioticima, upala limfnih žila

upala tankog tkiva kojim je obložena unutarnja stijenka trbuha i koja prekriva trbušne organe

povećani limfni čvorovi (ponekad bolni), zatajenje koštane srži, povećani broj eozinofila

smanjena funkcija nadbubrežne žlijezde, smanjena aktivnost štitnjače

poremećaj moždane funkcije, simptomi slični Parkinsonovoj bolesti, ozljeda živca s

posljedičnom utrnulošću, boli, trncima ili žarenjem u šakama ili stopalima

smetnje ravnoteže ili koordinacije

oticanje mozga

dvoslike, ozbiljna stanja oka uključujući: bol i upala oka i vjeđa, neuobičajeni očni pokreti,

oštećenje očnog živca s posljedičnim oštećenjem vida, oticanje vidnog diska

smanjen osjet dodira

poremećen osjet okusa

poteškoće sa sluhom, zvonjenje u ušima, vrtoglavica

upala određenih unutarnjih organa – gušterače i dvanaesnika, oticanje i upala jezika

povećanje jetre, zatajenje jetre, bolest žučnog mjehura, žučni kamenci

upala zglobova,upala vena ispod kože (što može biti povezano sa stvaranjem krvnog ugruška)

upala bubrega, bjelančevine u mokraći, oštećenje bubrega

vrlo brzi otkucaji srca ili preskočeni otkucaji srca, katkad s nasumičnim električnim impulsima

poremećaj elektrokardiograma (EKG-a)

povišen kolesterol u krvi, povišena ureja u krvi

alergijske kožne reakcije (ponekad teške), uključujući kožna stanja opasna po život koja

uzrokuju bolne mjehure i rane na koži i sluznici, posebice u ustima, upalu kože, koprivnjaču,

opekline od sunca ili tešku kožnu reakciju uslijed izlaganja svjetlosti ili suncu, crvenilo i

nadraženost kože, crvenu ili ljubičastu promjenu boje kože koja može biti prouzročena niskim

brojem trombocita, ekcem

reakcija na mjestu infuzije

alergijska reakcija ili pretjerani imunološki odgovor

Rijetke: mogu se javiti u do 1 na 1000 osoba

prekomjerna aktivnost štitnjače

propadanje moždane funkcije koja je ozbiljna komplikacija jetrene bolesti

gubitak većine vlakana vidnog živca i zamagljenje rožnice, nevoljni pokreti oka

povećana osjetljivost na svjetlost popraćena mjehurićima

poremećaj u kojem imunosni sustav tijela napada dio perifernog živčanog sustava

problemi s ritmom ili provođenjem otkucaja srca (ponekad opasni po život)

alergijska reakcija opasna po život

poremećaji u zgrušavanju krvi

alergijska reakcija kože (katkad ozbiljna), uključujući brzo oticanje (edem) kože, potkožnog

tkiva, sluznice i podsluznice, svrab ili bolna područja zadebljale, crvene kože sa srebrnastim

kožnim ljuskicama, nadraženost kože i sluznice, kožna stanja opasna po život koja uzrokuju

odvajanje velikih površina epidermisa, gornjeg sloja kože, od donjih dijelova kože

male suhe ljuskaste mrlje na koži, katkad debele sa šiljcima ili „rogovima“

Nuspojave s nepoznatom učestalošću:

pjege i pigmentirane mrlje

Druge značajne nuspojave čija učestalost nije poznata, ali moraju se odmah prijaviti Vašem liječniku:

rak kože

upala tkiva oko kosti

crvene, ljuskaste mrlje ili prstenasta oštećenja na koži koji mogu biti simptomi autoimune

bolesti zvane kožni eritemski lupus

S obzirom da je poznato da Voriconazole Accord utječe na jetru i bubrege, liječnik Vam mora pratiti

funkciju jetre i bubrega putem krvnih pretraga. Obavijestite svog liječnika ako imate bolove u trbuhu

ili ako se promijeni uobičajeni izgled stolice.

Prijavljen je rak kože u bolesnika koji su liječeni lijekom Voriconazole Accord kroz duži vremenski

period.

Opekline od sunca ili teška kožna reakcija uslijed izlaganja svjetlosti ili suncu nastale su češće u djece

Ako Vi ili Vaše dijete primijetite promjene na koži, Vaš liječnik može Vas uputiti dermatologu, koji

nakon pregleda može ustanoviti da je važno da Vi ili Vaše dijete redovito dolazite na kontrolu.

Povišeni jetreni enzimi zabilježeni su češće kod djece.

Obavijestite liječnika ako bilo koja od navedenih nuspojava potraje ili postane zabrinjavajuća.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika ili 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 čuvati Voriconazole Accord

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

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 pakiranja i druge informacije

Što Voriconazole Accord sadrži

Djelatna tvar je vorikonazol. Jedna tableta sadrži ili 50 mg vorikonazola (Voriconazole Accord

50 mg filmom obložene tablete) ili 200 mg vorikonazola (Voriconazole Accord 200 mg filmom

obložene tablete).

Drugi sastojci su: laktoza hidrat, prethodno geliran škrob, umrežena karmelozanatrij, povidon i

magnezijev stearat koji čine jezgru tablete te hipromeloza, titanijev dioksid (E171), laktoza

hidrat i triacetin koji čine film ovojnicu.

Kako Voriconazole Accord izgleda i sadržaj pakiranja

Voriconazole Accord 50 mg filmom obložene tablete su bijele do gotovo bijele, okrugle filmom

obložene tablete promjera otprilike 7,0 mm s utisnutom oznakom "V50" na jednoj i bez oznake na

suprotnoj strani.

Voriconazole Accord 200 mg filmom obložene tablete su bijele do gotovo bijele, ovalne, filmom

obložene tablete dužine otprilike 15,6 mm i širine otprilike 7,8 mm, s utisnutom oznakom "V200" na

jednoj i bez oznake na suprotnoj strani.

Voriconazole Accord 50 mg filmom obložene tablete i Voriconazole Accord 200 mg filmom obložene

tablete dostupne su u pakiranjima od 2, 10, 14, 20, 28, 30, 50, 56 i 100 tableta ili blisteri

(PVC/aluminij) s jediničnim dozama, u kutijama sa 10x1, 14x1, 28x1, 30x1, 56x1 ili 100x1 filmom

obloženom tabletom.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Accord Healthcare Limited,

Sage House, 319 Pinner road,

North Harrow,

Middlesex, HA1 4HF,

Ujedinjeno Kraljevstvo

Proizvođač

Accord Healthcare Limited,

Sage House, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF,

Ujedinjeno Kraljevstvo

Pharmacare Premium Ltd

HHF 003, Hal Far Industrial Estate,

Birzebbugia, BBG 3000, Malta

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

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

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

Vfend (Active substance: voriconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6490 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000387/T/0130

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

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