Aripiprazole Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Psycholeptics
  • Područje terapije:
  • Bipolarni poremećaj
  • Terapijske indikacije:
  • Aripiprazolni sporazum je indiciran za liječenje shizofrenije kod odraslih i adolescenata starijih od 15 godina. ; Арипипразол Ugovora naznačeno za liječenje od umjerenih do teških maničnih epizoda kada je bipolarni poremećaj poremećaj i za prevenciju novog manic epizoda kod odraslih, koji su doživjeli pretežno manične epizode, a čiji je manične epizode odgovorio na арипипразол u liječenju. ; Aripiprazol Accord je indiciran za liječenje do 12 tjedana umjerenih do teških maničnih epizoda u bipolarnom I poremećaju u adolescenata u dobi od 13 godina i više.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/004021
  • Datum autorizacije:
  • 16-11-2015
  • EMEA koda:
  • EMEA/H/C/004021
  • Zadnje ažuriranje:
  • 26-02-2018

Izvješće o ocjeni javnog

© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/634874/2015

EMEA/H/C/004021

EPAR, sažetak za javnost

Aripiprazole Accord

aripiprazol

Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aripiprazole 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 Aripiprazole Accord.

Praktične informacije o korištenju lijeka Aripiprazole Accord pročitajte u uputi o lijeku ili se obratite

svojem liječniku ili ljekarniku.

Što je Aripiprazole Accord i za što se koristi?

Aripiprazole Accord koristi se u bolesnika sa sljedećim mentalnim bolestima:

shizofrenijom, mentalnom bolesti koja se očituje nizom simptoma, uključujući neorganiziranim

razmišljanjem i govorom, halucinacijama (bolesnici čuju ili vide nešto čega nema), sumnjama i

iluzijama (pogrešna vjerovanja). Aripiprazole Accord koristi se u bolesnika u dobi od 15 godina ili

starijih;

kod bipolarnog poremećaja tipa I, mentalne bolesti u slučaju koje bolesnici imaju manične epizode

(razdoblja abnormalno visokog raspoloženja), koje se izmjenjuju s razdobljima normalnog

raspoloženja. Ovi bolesnici mogu imati i epizode depresije. Aripiprazole Accord koristi se u odraslih

osoba za liječenje umjerenih do ozbiljnih maničnih epizoda i za sprječavanje novih maničnih

epizoda u odraslih osoba koje su odgovorile na lijek u prošlosti. Aripiprazole Accord se također

koristi u razdoblju do 12 tjedana za liječenje umjerenih do ozbiljnih maničnih epizoda u bolesnika u

dobi od 13 godina i starijih.

Aripiprazole Accord sadrži djelatnu tvar aripiprazol i predstavlja „generički lijek”. To znači da je

Aripiprazole Accord sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom

Abilify. Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje

Aripiprazole Accord

EMA/634874/2015

Stranica 2/3

Kako se koristi Aripiprazole Accord?

Lijek Aripiprazole Accord dostupan je u tabletama (5, 10, 15 i 30 mg), a izdaje se samo na liječnički

recept.

U slučaju shizofrenije preporučena početna doza iznosi 10 ili 15 mg peroralno na dan za odrasle osobe,

nakon čega slijedi doza „održavanja” od 15 mg jednom na dan. U bolesnika u dobi između 15 i 17

godina, početna doza iznosi 2 mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u

tekućem obliku) i postupno se povećava do preporučene doze od 10 mg jednom na dan.

Za liječenje maničnih epizoda u slučaju bipolarnog poremećaja, preporučena početna doza u odraslih

osoba iznosi 15 mg peroralno jednom na dan, bilo samostalno ili u kombinaciji s drugim lijekovima.

Kako bi se spriječile manične epizode u odraslih osoba, treba nastaviti terapiju istom dozom.

Za potrebe liječenja maničnih epizoda u bolesnika u dobi između 13 i 17 godina, početna doza iznosi 2

mg na dan (primjenom lijeka koji sadrži aripiprazol dostupnog u tekućem obliku) i postupno se

povećava do preporučene doze od 10 mg jednom na dan. Terapija ne smije trajati dulje od 12 tjedana.

Dozu treba prilagoditi u bolesnika koji uzimaju druge lijekove koji mogu utjecati na način razgradnje

lijeka Aripiprazole Accord u tijelu. Dodatne informacije pročitajte u sažetku opisa svojstava lijeka

(također dio EPAR-a).

Kako djeluje Aripiprazole Accord?

Aripiprazol, djelatna tvar u lijeku Aripiprazole Accord, je antipsihotik. Točan mehanizam njegova

djelovanja nije poznat, no on se veže na nekoliko različitih receptora na površini živčanih stanica u

mozgu. To prekida signale koje između moždanih stanica prenose „neurotransmiteri”, kemikalije koje

omogućavaju međusobnu komunikaciju živčanih stanica. Smatra se da aripiprazol djeluje uglavnom

kao „parcijalni agonist” za receptore neurotransmitera dopamina i 5-hidroksitriptamina (također zvani

serotonin). To znači da aripiprazol djeluje kao dopamin i 5-hidroksitriptamin aktivirajući te receptore,

ali manje snažno od neurotransmitera. S obzirom na to da su dopamin i 5-hidroksitriptamin uključeni u

shizofreniju i bipolaran poremećaj, aripiprazol pomaže u normalizaciji moždane aktivnosti smanjujući

psihotičke ili manične simptome i sprečavajući njihov povratak.

Kako je Aripiprazole Accord ispitivan?

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

ispitivanja za utvrđivanje je li lijek bioekvivalentan referentnom lijeku Abilify. Dva su lijeka

bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.

Koje su koristi i rizici lijeka Aripiprazole Accord?

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

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

Zašto je lijek Aripiprazole Accord odobren?

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

EU-a potvrđeno kako Aripiprazole Accord posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom

Abilify. Stoga je stav CHMP-a da, kao i u pogledu lijeka Abilify, koristi nadmašuju utvrđene rizike.

Odbor je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Aripiprazole Accord u EU-u.

Aripiprazole Accord

EMA/634874/2015

Stranica 3/3

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Aripiprazole Accord?

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

Accord. Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Aripiprazole

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

djelatnici i bolesnici trebaju pridržavati.

Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom

Nadalje, proizvođač lijeka Aripiprazole Accord dostavit će edukacijske materijale za bolesnike ili njihove

pružatelje skrbi i liječnike kako bi se pojasnila sigurna primjena lijeka u bolesnika u dobi između 13 i

17 godina.

Ostale informacije o lijeku Aripiprazole Accord

Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Aripiprazole Accord nalaze se na

internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public

assessment reports. Više informacija o terapiji lijekom Aripiprazole Accord pročitajte u uputi o lijeku

(također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.

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

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za korisnika

Aripiprazol Accord 5 mg tablete

Aripiprazol Accord 10 mg tablete

Aripiprazol Accord 15 mg tablete

Aripiprazol Accord 30 mg tablete

aripiprazol

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 svom liječniku ili ljekarniku.

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 ili ljekarnika. To uključuje

i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Aripiprazol Accord i za što se koristi

Što morate znati prije nego počnete uzimati Aripiprazol Accord

Kako uzimati Aripiprazol Accord

Moguće nuspojave

Kako čuvati Aripiprazol Accord

Sadržaj pakiranja i druge informacije

1.

Što je Aripiprazol Accord i za što se koristi

Aripiprazol Accord sadrži djelatnu tvar aripiprazol i pripada skupini lijekova koji se zovu

antipsihotici. Koristi se za liječenje odraslih i adolescenata u dobi od 15 ili više godina koji boluju od

bolesti karakterizirane simptomima kao što su da bolesnik čuje vidi ili osjeća stvari kojih nema,

sumnjičavost, pogrešno vjerovanje, nepovezan govor i ponašanje te emocionalna tupost. Osobe s

ovom bolešću također mogu osjećati depresiju, krivnju, tjeskobu ili napetost.

Ovaj se lijek koristi za liječenje odraslih osoba te adolescenata u dobi od 13 godina i starijih koji

boluju od stanja čiji su simptomi “povišeno” raspoloženje, pretjerana količina energije, potreba za

manjom količinom sna nego obično, vrlo brz govor i ubrzan tijek misli te ponekad teška razdražljivost.

Također sprječava povratak takvog stanja u odraslih bolesnika koji su prethodno imali odgovor na

terapiju ovim lijekom.

2.

Što morate znati prije nego počnete uzimati Aripiprazol Accord

Nemojte uzimati Aripiprazol Accord

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

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego što uzmete Aripiprazol Accord.

Tijekom liječenja aripiprazolom zabilježene su samoubilačke misli i ponašanje. Odmah obavijestite

svog liječnika ako razmišljate o tome da si naudite.

Prije liječenja lijekom Aripiprazol Accord, obavijestite svog liječnika ako bolujete od

povišenog šećera u krvi (karakteriziranog simptomima poput pretjerane žeđi, obilnog mokrenja,

povećanog apetita i osjećaja slabosti) ili šećerne bolesti u obiteljskoj povijesti bolesti

napadaja budući da će Vas liječnik možda željeti pažljivije nadzirati

nevoljnih, nepravilnih mišićnih pokreta, osobito na licu

srčanih i krvožilnih bolesti, srčanih ili krvožilnih bolesti u obitelji, moždanog udara ili „mini“

moždanog udara, abnormalnog krvnog tlaka

krvnih ugrušaka ili krvnih ugrušaka u obiteljskoj povijesti bolesti, jer su antipsihotici povezani s

razvojem krvnih ugrušaka

prethodnog iskustva pretjeranog kockanja

ako ste u prošlosti imali problema s prekomjernim kockanjem

Ako primijetite povećanje tjelesne težine, pojavu neuobičajenih pokreta, izrazitu pospanost koja Vas

ometa u obavljanju normalnih svakodnevnih aktivnosti, poteškoće s gutanjem ili alergijske simptome,

molimo obavijestite o tome svog liječnika.

Ako ste starija osoba i bolujete od demencije (gubitka pamćenja i drugih mentalnih sposobnosti), Vi ili

Vaš skrbnik/član obitelji morate obavijestiti liječnika ako ste preboljeli moždani udar ili „mali“

moždani udar.

Odmah obavijestite svog liječnika ako imate misli o samoozljeđivanju ili osjećate da biste si mogli

nauditi. Samoubilačke misli i ponašanja prijavljena su tijekom liječenja aripiprazolom.

Odmah obavijestite svog liječnika ako bolujete od ukočenosti ili nesavitljivost mišića s visokom

vrućicom, znojenjem, promijenjenim mentalnim statusom ili jako ubrzanim ili nepravilnim otkucajima

srca.

Obavijestite liječnika ako Vi ili Vaša obitelj/njegovatelj(ica) primijetite da razvijate snažnu potrebu ili

žudnju za ponašanjem na za Vas neobičan način, te se ne možete oduprijeti nagonu, porivu ili

iskušenju da vršite određene aktivnosti koje bi mogle naškoditi Vama ili drugima. Oni se nazivaju

poremećajima kontrole nagona te mogu uključivati ponašanja kao što je ovisničko kockanje,

prekomjerno jedenje ili trošenje, abnormalno izražen seksualni poriv ili učestalo razmišljanje s

povećanom količinom seksualnih misli ili osjećaja.

Liječnik će možda morati prilagoditi ili ukinuti Vašu dozu.

Djeca i adolescenti

Nemojte primjenjivati ovaj lijek u djece i adolescenata mlađih od 13 godina. Nije poznato je li siguran

i djelotvoran u tih bolesnika.

Drugi lijekovi i Aripiprazol Accord

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

druge lijekove, uključujući lijekove koje ste nabavili bez recepta.

Lijekovi za snižavanje krvnog tlaka: Aripiprazol Accord može pojačati učinak lijekova koji se koriste

za snižavanje krvnog tlaka. Obavezno obavijestite svog liječnika ako uzimate lijek za kontrolu krvnog

tlaka.

Uzimanje lijeka Aripiprazol Accord s nekim lijekovima može značiti da će Vam liječnik morati

promijeniti dozu lijeka Aripiprazol Accord ili tih drugih lijekova. Osobito je važno da kažete liječniku

ako uzimate sljedeće:

lijekove za regulaciju srčanog ritma (kao što su kinidin, amiodaron i flekainid)

antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su

fluoksetin, paroksetin, venlafaksin, gospina trava)

lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol)

određene lijekove za liječenje HIV-infekcije (kao što su efavirenz, nevirapin, inhibitori

proteaze, npr. indinavir, ritonavir)

antikonvulzive koji se primjenjuju za liječenje epilepsije (kao što su karbamazepin, fenitoin,

fenobarbital)

određene antibiotike koji se primjenjuju za liječenje tuberkuloze (rifabutin, rifampicin).

Ti lijekovi mogu povećati rizik od nuspojava ili smanjiti učinak lijeka Aripiprazol Accord; ako

dobijete neki neobični simptom dok uzimate ove lijekove zajedno s lijekom Aripiprazol Accord,

trebate se obratiti liječniku.

Lijekovi koji povisuju razinu serotonina obično se primjenjuju u stanjima koja uključuju depresiju,

generalizirani anksiozni poremećaj, opsesivno-kompulzivni poremećaj (OKP) i socijalnu fobiju, kao i

migrenu i bol:

triptani, tramadol i triptofan koji se primjenjuju u stanjima koja uključuju depresiju,

generalizirani anksiozni poremećaj, opsesivno kompulzivni poremećaj (OKP) i socijalnu fobiju,

kao i migrenu i bol

inhibitori ponovne pohrane serotonina (SSRI) (kao što su paroksetin i fluoksetin) koji se

primjenjuju kod depresije, opsesivno-kompulzivnog poremećaja, panike i tjeskobe

drugi antidepresivi (kao što su venlafaksin i triptofan) koji se primjenjuju kod velike depresije

triciklički antidepresivi (kao što su klomipramin i amitriptilin) koji se primjenjuju kod

depresivne bolesti

gospina trava (

Hypericum perforatum

) koja se primjenjuje kao biljni lijek kod blage depresije

lijekovi protiv bolova (kao što su tramadol i petidin) koji se primjenjuju za ublažavanje boli

triptani (kao što su sumatriptan i zolmitriptan) koji se primjenjuju za liječenje migrene.

Ovi lijekovi mogu povećati rizik od nuspojava; ako dobijete ikakve neobične simptome dok uzimate

neki od ovih lijekova zajedno s lijekom Aripiprazol Accord, trebate se obratiti liječniku.

Aripiprazol Accord s hranom, pićem i alkoholom

Ovaj lijek se može uzimati neovisno o obrocima.

Alkohol treba izbjegavati.

Trudnoća, dojenje i plodnost

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

liječniku za savjet prije nego uzmete ovaj lijek.

Sljedeći simptomi se mogu javiti u novorođenčadi majki koje su uzimale ovaj lijek u posljednjem

tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost mišića, pospanost,

uznemirenost, tegobe s disanjem i poteškoće s hranjenjem. Ako se kod Vaše bebe razvije bilo koji od

ovih simptoma, možda ćete trebati obavijestiti svog liječnika.

Ako uzimate Aripiprazol Accord, Vaš će liječnik razgovarati s Vama o tome trebate li dojiti uzimajući

u obzir korist liječenja za Vas i korist dojenja za dijete. Ne smijete istodobno dojiti i primati lijek.

Razgovarajte sa svojim liječnikom o najboljem načinu na koji hraniti svoje dijete ako uzimate ovaj

lijek.

Upravljanje vozilima i strojevima

Tijekom liječenja ovim lijekom mogu se javiti omaglica i problemi s vidom (pogledajte dio 4.). To je

potrebno uzeti u obzir u slučajevima u kojima je potrebna puna pozornost, npr., prilikom upravljanja

vozilom ili rukovanja strojevima.

Aripiprazol Accord sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, obavijestite svog liječnika prije nego što

počnete uzimati ovaj lijek.

3.

Kako uzimati Aripiprazol Accord

Uvijek uzmite ovaj lijek točno onako kako Vam rekli Vaš liječnik ili ljekarnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Preporučena doza za odrasle je 15 mg jedanput dnevno.

Međutim, liječnik Vam može propisati

nižu ili višu dozu, koja smije iznositi maksimalno 30 mg jedanput dnevno.

Primjena u djece i adolescenata

Kako bi se omogućio početak liječenja pri niskoj dozi, možete koristiti drugu formulaciju (oralnu

otopinu - tekućinu) koja je prikladnija od lijeka Aripiprazol Accord.

Doza se može postupno povećavati do

preporučene doze za adolescente od 10 mg jedanput

dnevno

. Međutim, liječnik Vam može propisati nižu ili višu dozu, koja smije iznositi maksimalno

30 mg jedanput dnevno.

Ako imate dojam da je učinak ovog lijeka prejak ili preslab, obratite se svom liječniku ili ljekarniku.

Pokušajte uzimati Aripiprazol Accord svaki dan u isto vrijeme.

Nije važno uzimate li ih s hranom

ili ne. Tabletu uvijek pijte s vodom i progutajte je cijelu.

Čak i ako se osjećate bolje,

nemojte mijenjati dozu niti prekidati svakodnevno uzimanje ovog lijeka

bez prethodnog savjetovanja s liječnikom.

Ako uzmete više lijeka Aripiprazol Accord nego što ste trebali

Ako shvatite da ste uzeli više lijeka Aripiprazol Accord nego što Vam je preporučio liječnik (ili ako je

neka druga osoba uzela dio Vašeg lijeka Aripiprazol Accord), odmah o tome obavijestite svog

liječnika. Ako ne možete stupiti u kontakt sa svojim liječnikom, pođite u najbližu bolnicu i ponesite

pakiranje sa sobom.

Bolesnici koji su uzeli previše aripiprazola imali su sljedeće simptome:

ubrzane otkucaje srca, uznemirenost/agresivnost, otežan govor,

neobične kretnje (osobito lica ili jezika) i sniženu razinu svijesti.

Drugi simptomi mogu uključivati:

akutnu smetenost, napadaje (epilepsiju), komu, kombinaciju vrućice, ubrzanog disanja,

znojenja,

ukočenosti mišića i omamljenosti ili pospanosti, usporeno disanje, gušenje, visok ili nizak krvni

tlak, abnormalni srčani ritam.

Odmah se javite liječniku ili u bolnicu ako osjetite bilo koji od gore opisanih simptoma.

Ako ste zaboravili uzeti Aripiprazol Accord

Ako ste propustili uzeti dozu, uzmite je čim se sjetite, ali nemojte uzeti dvije doze u jednom danu.

Ako prestanete uzimati Aripiprazol Accord

Nemojte prekinuti liječenje samo zato što se osjećate bolje. Važno je da nastavite uzimati Aripiprazol

Accord onoliko dugo koliko Vam je to rekao liječnik.

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

4.

Moguće nuspojave

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

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

šećerna bolest,

poteškoće sa spavanjem,

osjećaj tjeskobe,

osjećaj uznemirenosti i nemogućnost mirovanja, poteškoće s mirnim sjedenjem,

nekontrolirano trzanje mišića, trzajni ili savijajući pokreti, nemirne noge,

drhtanje,

glavobolja,

umor,

pospanost,

ošamućenost,

tresenje i zamagljen vid,

rjeđe ili otežano pražnjenje crijeva,

loša probava,

mučnina,

veća količina sline u ustima no obično,

povraćanje,

osjećaj umora.

Manje česte nuspojave (mogu se javiti od 1 na 100 osoba):

povišene razine hormona prolaktina u krvi,

previše šećera u krvi,

depresija,

promijenjen ili pojačan seksualni nagon,

nekontrolirani pokreti usta, jezika i udova (tardivna diskinezija),

poremećaj mišića koji uzrokuje pokrete uvijanja (distonija),

dvoslike,

ubrzani otkucaji srca,

pad krvnog tlaka pri ustajanju koji uzrokuje omaglicu, ošamućenost ili nesvjesticu,

štucavica.

Sljedeće nuspojave prijavljene su nakon stavljanja aripiprazola u promet, ali njihova učestalost nije

poznata:

nizak broj bijelih krvnih stanica,

nizak broj krvnih pločica,

alergijska reakcija (npr. oticanje usta, jezika, lica i grla, svrbež, koprivnjača),

početak ili pogoršanje šećerne bolesti, ketoacidoza (ketoni u krvi i mokraći) ili koma,

povišen šećer u krvi,

nedovoljna razina natrija u krvi,

gubitak apetita (anoreksija),

smanjenje tjelesne težine,

povećanje tjelesne težine,

misli o samoubojstvu, pokušaj samoubojstva i samoubojstvo;

agresivnost,

uznemirenost,

nervoza,

kombinacija vrućice, ukočenosti mišića, ubrzanog disanja, znojenja, smanjene svijesti i

iznenadnih promjena krvnog tlaka i brzine otkucaja srca, nesvjestica (neuroleptički maligni

sindrom)

napadaji,

serotoninski sindrom (reakcija koje može dovesti do osjećaja velike sreće, omamljenosti,

nespretnosti, nemira, osjećaja pijanstva, vrućice, znojenja ili ukočenih mišića),

poremećaj govora,

iznenadna neobjašnjiva smrt,

za život opasni nepravilni otkucaji srca,

srčani udar,

usporeni otkucaji srca,

krvni ugrušci u venama osobito nogu (simptomi uključuju oticanje, bol i crvenilo noge), koji

mogu putovati kroz krvne žile do pluća i tamo prouzročiti bol u prsištu i otežano disanje (ako

primijetite neki od navedenih simptoma, odmah potražite liječničku pomoć);

visoki krvni tlak,

nesvjestica,

slučajno udisanje hrane uz rizik od razvoja pneumonije (upale pluća),

grč mišića oko govornog aparata,

upala gušterače,

otežano gutanje,

proljev,

nelagoda u trbuhu,

nelagoda u želucu,

zatajenje jetre,

upala jetre,

žuta boja kože i bjeloočnica,

abnormalne vrijednosti jetrenih pretraga,

kožni osip,

osjetljivost na svjetlost,

ćelavost,

pojačano znojenje;

abnormalna razgradnja mišića koja može dovesti do bubrežnih tegoba,

bol u mišićima,

ukočenost,

nemogućnost kontroliranja mokrenja (inkontinencija),

poteškoće pri mokrenju,

simptomi ustezanja u novorođenčadi u slučaju izloženosti tijekom trudnoće,

produžena i/ili bolna erekcija,

poteškoće s kontroliranjem osnovne tjelesne temperature ili pregrijavanje,

bol u prsištu,

oticanje šaka, gležnjeva ili stopala,

krvne pretrage: fluktuacija šećera u krvi, povišeni glikirani hemoglobin,

nemogućnost odupiranja nagonu, porivu ili iskušenju za vršenje radnji koje bi mogle naškoditi

Vama ili drugima, što može uključivati:

snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili

obitelj,

promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili

druge, na primjer, povećani seksualni poriv,

pretjerano kupovanje ili trošenje koje se ne može kontrolirati,

prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno

jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za

utaženje gladi),

sklonost da se odluta.

Obavijestite liječnika ako primijetite neko od ovih ponašanja, tako da možete raspraviti o

načinima njihova zbrinjavanja ili smanjivanja simptoma.

U starijih bolesnika s demencijom prijavljeno je više smrtnih slučajeva za vrijeme liječenja

aripiprazolom. Osim toga, prijavljeni su slučajevi moždanog udara ili „malog“ moždanog udara.

Dodatne nuspojave u djece i adolescenata

Adolescenti u dobi od 13 ili više godina imali su nuspojave slične učestalosti i vrste kao i odrasli

bolesnici, osim što su pospanost, nekontrolirano trzanje mišića ili trzajni pokreti, nemir i umor bili vrlo

česti (mogu se javiti u više od 1 na 10 osoba), dok su bol u gornjem dijelu trbuha, suha usta, ubrzani

otkucaji srca, povećanje tjelesne težine, pojačan apetit, trzanje mišića, nekontrolirani pokreti udova i

osjećaj omaglice, osobito pri ustajanju iz ležećeg ili sjedećeg položaja, bili česti (mogu se javiti u do 1

na 10 osoba).

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. 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 Aripiprazol Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru ili naljepnici i

kutiji iza oznake „Rok valjanosti“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

HDPE bocu treba iskoristiti u roku od 30 dana nakon prvog otvaranja. (za bocu s 30 tableta)

HDPE bocu treba iskoristiti u roku od 100 dana nakon prvog otvaranja. (za bocu sa 100 tableta)

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 Aripiprazol Accord tablete sadrže

Djelatna tvar je aripiprazol.

Aripiprazol Accord 5 mg tablete: Jedna tableta sadrži 5

mg aripiprazola.

Aripiprazol Accord 10 mg tablete: Jedna tableta sadrži 10

mg aripiprazola.

Aripiprazol Accord 15 mg tablete: Jedna tableta sadrži 15

mg aripiprazola.

Aripiprazol Accord 30 mg tablete: Jedna tableta sadrži 30

mg aripiprazola.

Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, kukuruzni škrob,

hidroksipropilceluloza, magnezijev stearat i boja

Indigo carmine aliminium lake

(E132) (za 5

mg) ili crveni željezov oksid (E172) (za 10 mg i 30 mg) ili žuti željezov oksid (E172) (za 15

mg).

Kako Aripiprazol Accord tablete izgledaju i sadržaj pakiranja

Aripiprazol Accord 5 mg tablete su plave, bikonveksne neobložene tablete modificiranog pravokutnog

oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A5“ na jednoj strani i bez oznake

na drugoj strani.

Aripiprazol Accord 10 mg tablete su ružičaste, bikonveksne neobložene tablete modificiranog

pravokutnog oblika duge oko 8,1 mm i široke oko 4,6 mm s utisnutom oznakom „A10“ na jednoj

strani i bez oznake na drugoj strani.

Aripiprazol Accord 15 mg tablete su žute, okrugle, bikonveksne neobložene tablete ukošene na

rubovima, promjera oko 7,14 mm s utisnutom oznakom „A15“ na jednoj strani i bez oznake na drugoj

strani.

Aripiprazol Accord 30 mg tablete su ružičaste, okrugle, bikonveksne neobložene tablete ukošene na

rubovima, promjera oko 9,1 mm s utisnutom oznakom „A30“ na jednoj strani i bez oznake na drugoj

strani.

Aripiprazol Accord 5/10/15/30 mg tablete dostupne su u peforiranim blisterima (aluminij/aluminij)

djeljivim na jedinične doze u veličinama pakiranja od 14x1, 28x1, 49x1, 56x1 ili 98x1 tableta.

Aripiprazol Accord 5/10/15 mg tablete također su dostupne u HDPE boci s PPCRC čepom koja sadrži

30 ili 100 tableta.

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

Wessling Hungary Kft

Fòti ùt 56., Budimpešta 1047,

Mađarska

Ova uputa je zadnji puta revidirana u

Drugi izvori informacija

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

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

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

29-8-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Europe Ltd)

ABILIFY MAINTENA (Otsuka Pharmaceutical Europe Ltd)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Renewal - Commission Decision (2018)5780 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2755/R/25

Europe -DG Health and Food Safety

28-8-2018

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5681 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/471/T/131

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