Temozolomide Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Antineoplastična sredstva
  • Područje terapije:
  • glioblastom
  • Terapijske indikacije:
  • Za liječenje odraslih bolesnika s novodijagnosticiranim višestrukim glioblastomom istodobno s radioterapijom (RT) i kasnije kao terapija monoterapijom.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/001125
  • Datum autorizacije:
  • 15-03-2010
  • EMEA koda:
  • EMEA/H/C/001125
  • Zadnje ažuriranje:
  • 04-03-2018

Izvješće o ocjeni javnog

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

EMA/329022/2015

EMEA/H/C/001125

EPAR, sažetak za javnost

Temozolomide Accord

temozolomid

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

Accord. Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio

svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima

za primjenu lijeka Temozolomide Accord.

Što je Temozolomide Accord?

Temozolomide Accord je lijek protiv raka koji sadrži djelatnu tvar temozolomid. Dostupan je u

kapsulama (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).

Temozolomide Accord je „generički lijek”. Drugim riječima, Temozolomide Accord je sličan

„referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Temodal. Više informacija o

generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje

Za što se Temozolomide Accord koristi?

Temozolomide Accord koristi se za liječenje malignih glioma (tumora mozga) u sljedećim grupama

bolesnika:

u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom (agresivnim tipom

malignog glioma). Temozolomide Accord se prvo koristi istodobno s radioterapijom, a zatim kao

monoterapija;

u odraslih bolesnika i djece od navršene tri godine starosti s malignim gliomom, kao što je

multiformni glioblastom ili anaplastični astrocitom, koji je recidivirao ili napreduje nakon

standardne terapije. Temozolomide Accord se koristi kao monoterapija u ovih bolesnika.

Ovaj se lijek izdaje samo na liječnički recept

Ranije poznat pod imenom Temozolomide Hospira

Temozolomide Accord0F

EMA/329022/2015

Stranica 2/2

Kako se Temozolomide Accord koristi?

Liječenje lijekom Temozolomide Accord smiju propisivati samo liječnici s iskustvom u onkološkom

liječenju tumora mozga.

Doza Temozolomide Accord ovisi o tjelesnoj površini bolesnika (izračunava se pomoću visine i tjelesne

težine bolesnika) u rasponu od 75 do 200 mg po metru kvadratnom, jednom na dan. Doza i broj doza

ovise o tipu tumora koji se liječi, o činjenici je li bolesnik ranije primio terapiju, da li se Temozolomide

Accord koristi kao monoterapija ili u kombinaciji s drugim liječenjem te kako bolesnik odgovara na

liječenje. Temozolomide Accord treba uzimati bez hrane. Bolesnici će možda također trebati uzeti

lijekove da bi spriječili povraćanje prije uzimanja lijeka Temozolomide Accord.

Potpune informacije pročitajte u sažetku opisa svojstava proizvoda (također dio EPAR-a).

Kako djeluje Temozolomide Accord?

Djelatna tvar lijeka Temozolomide Accord, temozolomid, ubraja se u grupu citostatika pod nazivom

alkilirajući pripravci. U tijelu se temozolomid pretvara u drugi spoj naziva MTIC. MTIC se vezuje na

DNK u stanicama dok se one umnožavaju, što zaustavlja diobu stanica. To rezultira nemogućnošću

diobe stanica i usporavanjem rasta tumora.

Kako je Temozolomide Accord ispitivan?

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

utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Temodal. Dva lijeka su

bioekvivalentna kada u tijelu proizvode iste razine djelatne tvari.

Koje su koristi i rizici lijeka Temozolomide Accord?

Budući da je Temozolomide Accord generički lijek i bioekvivalent referentnom lijeku, smatra se da su

njegove koristi i rizici isti kao i oni referentnog lijeka.

Zašto je Temozolomide Accord odobren?

CHMP je zaključio kako je, u skladu s preduvjetima EU-a, potvrđeno kako Temozolomide Accord

posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Temodal. Stoga je stav CHMP-a kako

koristi nadmašuju utvrđene rizike, kao i kod lijeka Temodal. Odbor je preporučio izdavanje odobrenja

za stavljanje u promet lijeka Temozolomide Accord.

Ostale informacije o lijeku Temozolomide Accord

Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Temozolomide Hospira na

snazi u Europskoj uniji od 15. ožujka 2010. Naziv lijeka izmijenjen je u Temozolomide Accord

27. svibnja 2015.

Cjeloviti EPAR za lijek Temozolomide Accord nalazi se na internetskim stranicama

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

informacija o terapiji lijekom Temozolomide Accord pročitajte u uputi o lijeku (također dio EPAR-a), ili

se obratite svom liječniku ili ljekarniku.

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

Ovaj sažetak je posljednji put ažuriran u 05.2015.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacija za korisnika

Temozolomid Accord 5 mg tvrde kapsule

Temozolomid Accord 20 mg tvrde kapsule

Temozolomid Accord 100 mg tvrde kapsule

Temozolomid Accord 140 mg tvrde kapsule

Temozolomid Accord 180 mg tvrde kapsule

Temozolomid Accord 250 mg tvrde kapsule

temozolomid

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, 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 Temozolomid Accord i za što se koristi

Što morate znati prije nego počnete uzimati Temozolomid Accord

Kako uzimati Temozolomid Accord

Moguće nuspojave

Kako čuvati Temozolomid Accord

Sadržaj pakiranja i druge informacije

1.

Što je Temozolomid Accord i za što se koristi

Temozolomid Accord je lijek protiv raka.

Temozolomid Accord kapsule se koriste za liječenje specifičnih vrsta tumora mozga:

odraslih bolesnika s novodijagnosticiranim specifičnim oblikom tumora mozga (multiformnim

glioblastomom).

Temozolomid se prvo primjenjuje u kombinaciji s radioterapijom (faza istodobnog liječenja), a

zatim samostalno (faza monoterapije).

djece u dobi od 3 godine i starije te u odraslih bolesnika sa

specifičnim oblikom tumora mozga

(npr. multiformni glioblastom ili anaplastični astrocitom) kada se tumor ponovno pojavio ili se širi

nakon standardne terapije.

2.

Što morate znati prije nego počnete uzimati Temozolomid Accord

Nemojte uzimati Temozolomid Accord

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

ako ste imali alergijsku reakciju na drugi lijek protiv raka koji se zove dakarbazin. Znakovi

alergijske reakcje uključuju osjećaj svrbeži, nedostatak zraka ili piskanje pri disanju, oticanje

lica, usana, jezika ili grla.

ako imate smanjen broj krvnih stanica, kao što su bijele krvne stanice i krvne pločice. Te su

krvne stanice važne za borbu protiv infekcije te za pravilno zgrušavanje krvi. Liječnik će

provjeriti Vašu krvnu sliku kako bi ustanovio imate li dovoljan broj tih stanica prije početka

liječenja.

Upozorenja i mjere opreza

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

jer Vas se

mora pažljivo nadgledati zbog mogućeg razvoja teškog oblika infekcije koja se naziva upala

pluća uzrokovana s

Pneumocystis jirovecii

(PCP). Ako ste novodijagnosticirani bolesnik

(multiformni glioblastom), mogli biste primati temozolomid tijekom 42 dana u kombinaciji s

radioterapijom. U tom slučaju, liječnik će Vam također propisati lijek koji pomaže u

sprečavanju ove vrste upale pluća (PCP).

ako ste ikada imali ili trenutno možda imate infekciju hepatitisom B. Ovo je zato što

Temozolamid Accord može uzrokovati ponovnu aktivaciju hepatitisa B, što u nekim

slučajevima može imati smrtni ishod. Liječnik će detaljno pregledati bolesnike prije početka

liječenja kako bi se utvrdilo postoje li znakovi ove infekcije.

ako imate anemiju, smanjen broj krvnih stanica (poput bijelih krvnih stanica i tombocita) ili

probleme sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom

liječenja. Liječnik će možda smanjiti dozu, prekinuti liječenje ili će Vam biti potrebna druga

terapija. Liječnik će odlučiti je li potrebna bilo kakva promjena u Vašem liječenju. U nekim će

slučajevima možda biti neophodno prekinuti liječenje temozolomidom. Redovito će se provoditi

krvne pretrage radi praćenja Vašeg stanja. Ako dobijete vrućicu ili simptome infekcije, odmah

se obratite Vašem liječniku.

možete imati malen rizik od drugih promjena krvnih stanica, uključujući leukemiju.

ako imate mučninu ili povraćate što su vrlo česte nuspojave Temozolomida (vidjeti dio 4.). Ako

često povraćate prije ili za vrijeme liječenja, upitajte svog liječnika o lijekovima koji sprečavaju

povraćanje ili kontroliraju povraćanje i kada je najbolje uzimati temozolomid dok povraćanje ne

bude pod kontrolom. Ako povratite nakon uzimanja doze, nemojte uzeti sljedeću dozu istoga

dana.

ako razvijete vrućicu ili simptome infekcije, odmah se obratite svom liječniku.

ako ste stariji od 70 godina. Stariji bolesnici su skloniji infekcijama, stvaranju modrica ili

krvarenju.

ako imate problema s jetrom ili bubrezima jer će možda biti potrebno prilagoditi Vašu dozu.

Djeca i adolescenti

Ovaj lijek nije ispitivan u djece mlađe do 3 godine te im ga stoga nemojte davati. Informacije o

primjeni lijeka Temozolomid Accord u djece starije od 3 godine su ograničene.

Drugi lijekovi i Temozolomid Accord

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

druge lijekove.

Trudnoća, dojenje i plodnost

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

ljekarniku za savjet prije nego uzmete ovaj lijek. To je zbog toga što se ne smijete liječiti lijekom

Temozolomid Accord tijekom trudnoće, osim ako ga Vaš liječnik nije izričito propisao.

I bolesnice i bolesnici koji uzimaju Temozolomid Accord moraju primjenjivati učinkovite mjere

kontracepcije (vidjeti također „Plodnost muškaraca“ u daljnjem tekstu).

Ne smijete dojiti dok se liječite Temozolomidom Accord.

Plodnost muškaraca

Temozolomid Accord može uzrokovati trajnu neplodnost. Bolesnici muškog spola moraju

primjenjivati učinkovite mjere kontracepcije te ne smiju pokušavati začeti dijete do 6 mjeseci nakon

prestanka liječenja. Preporučuje se da potraže savjet o pohrani sperme prije početka liječenja.

Upitajte liječnika za savijet prije uzimanja bilo kojeg lijeka.

Upravljanje vozilima i strojevima

Temozolomid Accord može uzrokovati umor ili pospanost. U tom slučaju nemojte voziti niti rukovati

alatima ili strojevima ili voziti bicikl dok ne vidite kako ovaj lijek djeluje na Vas (vidjeti dio 4).

Temozolomid Accord sadrži laktozu

Kapsule sadrže laktozu (vrstu šećera). Ako Vam je liječnik rekao da ne podnosite neke šećere,

savjetujte se s liječnikom prije uzimanja ovog lijeka.

3.

Kako uzimati Temozolomid Accord

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

liječnikom ili ljekarnikom ako niste sigurni.

Kako se otvara vrećica

Vrećicu otvorite tako što ćete je saviti i otrgnuti duž preklopne linije s urezom u kutu vrećice.

Temozolomid smije propisati samo specijalist iskusan u liječenju tumora mozga.

Doziranje i trajanje liječ

enja

Vaš liječnik će odlučiti o ispravnoj dozi temozolomida za Vas na temelju Vaše veličine (visine i

težine) te o tome jeste li već primali kemoterapiju. Liječnik Vam može dati i neke druge lijekove koje

ćete uzimati prije i/ili nakon što uzmete lijek temozolomid radi izbjegavanja ili kontrole povraćanja.

Uzmite propisanu dozu lijeka Temozolomid Accord jedanput na dan. Dozu uzmite na prazan želudac,

primjerice, najmanje sat vremena prije nego što planirate doručkovati. Kapsulu(e) progutajte cijele, s

čašom vode. Nemojte otvarati, drobiti niti žvakati kapsule.

Ako je kapsula oštećena, izbjegavajte kontakt praška s kožom, očima ili nosom. Izbjegavajte udisanje

praha. Ako prah slučajno dospije u oči ili nos, isperite ih vodom.

Ako uzimate Temozolomid Accord u kombinaciji sa zračenjem (novodijagnosticirani bolesnici):

Za vrijeme zračenja liječnik će započeti primjenu temozolomida u dozi od 75 mg/m

, a stvarna dnevna

doza ovisti će o Vašoj visini i težini. Tu ćete dozu uzimati svakodnevno tijekom 42 dana (najdulje

49 dana) u kombinaciji sa zračenjem. Doza se može se odgoditi ili prekinuti ovisno o broju Vaših

krvnih stanica i o tome kako podnosite temozolomid.

Nakon završetka zračenja, prekinut ćete liječenje na 4 tjedna kako bi se Vaše tijelo moglo oporaviti.

Nakon toga liječenje se može odvijati do ukupno 6 terapijskih razdoblja (ciklusa), od kojih svaki traje

28 dana. Uzimat ćete novu dozu temozolomid kapsula u početnoj dozi od 150 mg/m

jedanput na dan

prvih 5 dana svakog ciklusa („dani doziranja“), nakon čega slijede 23 dana bez uzimanja lijeka

temozolomida, što čini ukupno 28 dana terapijskog ciklusa.

Nakon 28. dana započinje sljedeći ciklus u kojem ćete ponovno uzimati ovaj lijek jedanput na dan

tijekom 5 dana, nakon čega slijede 23 dana bez temozolomida. Ovisno o broju Vaših krvnih stanica i o

tome kako podnosite temozolomid u svakom terapijskom ciklusu, doza se može prilagoditi, odgoditi

ili prekinuti.

Ako uzimate Temozolomid Accord kapsule same (bez zračenja):

Ciklus liječenja lijekom Temozolomidom Accord traje 28 dana. Uzimat ćete kapsule jedanput na dan

prvih 5 dana nakon čega slijede 23 dana bez temozolomida, što čini ukupno 28 dana terapijskog

ciklusa.

Nakon 28. dana započinje sljedeći ciklus u kojem ćete ponovno uzimati ovaj lijek jedanput na dan

tijekom 5 dana, nakon čega slijede 23 dana bez temozolomida. Prije svakog novog ciklusa, napravit će

Vam krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu temozolomida.

Ako niste prethodno liječeni kemoterapijom, prva doza temozolomida bit će 200 mg/m

jedanput na

dan tijekom prvih 5 dana („dani doziranja“) nakon čega slijede 23 dana bez temozolomida. Ako ste

ranije već liječeni kemoterapijom, prva doza lijeka temozolomida bit će 150 mg/m

jedanput na dan

tijekom prvih 5 dana („dani doziranja“) nakon čega slijede 23 dana bez temozolomida.

S obzirom na rezultate krvnih pretraga, Vaš liječnik može prilagoditi dozu lijeka za sljedeći ciklus.

Prije početka svakog novog terapijskog ciklusa budite sigurni da ispravno razumijete koliko točno

kapsula koje jačine trebate uzimati svakog dana i koliko dana trebate uzimati određenu dozu.

Svi bolesnici

Temozolomid dolazi u kapsulama različitih jačina (prikazano na vanjskom označavanju u mg). Svaka

jačina kapsule ima kapicu druge boje. Ovisno o dozi temozolomida koju Vam je liječnik propisao,

možda ćete morati uzimati nekoliko kapsula u istom danu terapijskog ciklusa.

Budite sigurni da ste u potpunosti razumjeli koliko kapsula pojedine jačine morate uzeti. Zamolite

svog liječnika ili ljekarnika da Vam zapiše broj pojedine jačine (uključujući boju) koji morate

uzeti svakog dana doziranja.

Budite sigurni da točno znate koji dani su Vaši dani za uzimanje lijeka.

Budite sigurni da, svaki puta kada započinjete novi ciklus, provjerite s Vašim liječnikom dozu

lijeka. Ponekad se doza ili kombinacija kapsula koje trebate uzimati razlikuju od prethodnog

ciklusa.

Ako se zbunite ili niste sigurni kako uzimati svoju dozu nakon što donesete lijek doma, nazovite

radi ponovnog dobivanja uputa prije početka terapijskog ciklusa. Pogreške u načinu uzimanja

ovog lijeka mogu imati ozbiljne posljedice za zdravlje.

Ako uzmete više Temozolomida Accord nego što ste trebali

Ako zabunom uzmete više kapsula nego što ste trebali, odmah se javite svom liječniku, ljekarniku ili

medicinskoj sestri.

Ako ste zaboravili uzeti Temozolomid Accord

Uzmite propuštenu dozu što je prije moguće tijekom istog dana. Ako je prošao cijeli dan, provjerite s

Vašim liječnikom što da učinite. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu

dozu, osim ako Vam to nije rekao liječnik.

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.

Bolesnici koji uzimaju temozolomid u kombinaciji sa zračenjem mogu imati drugačije nuspojave od

bolesnika koji uzimaju samo temozolomid.

Odmah se obratite liječniku ako imate nešto od sljedećeg:

tešku alergijsku reakciju (osip koji može svrbiti, piskanje pri disanju ili druge tegobe s disanjem),

nekontrolirano krvarenje,

nekontrolirane napadaje,

vrućicu ili jaku glavobolju koja ne prestaje.

Liječenje temozolomidom može izazvati smanjenje broja nekih vrsta krvnih stanica. To može

uzrokovati povećanu sklonost modricama ili krvarenju, anemiju (nedostatak crvenih krvnih stanica),

vrućicu i/ili smanjenu otpornost na infekcije. Smanjenje broja krvnih stanica obično je kratkotrajno, ali

u nekim slučajevima može biti dugotrajno te dovesti do vrlo teškog oblika anemije (aplastična

anemija). Liječnik će Vam redovito kontrolirati krvnu sliku kako bi uočio eventualne promjene i

odlučiti je li potrebno specifično liječenje. U nekim slučajevima će Vaša doza temozolomida biti

smanjena ili ukinuta.

Slijedeće nuspojave mogu se pojaviti ako ste novodijagnosticirani bolesnik koji uzima Temozolomid

Accord zbog specifičnog tumora mozga (glioblastoma multiforme) u kombiniranom liječenju sa

zračenjem nakon čega slijedi uzimanje samo temozolomida. Medicinska pomoć može biti potrebna.

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

glavobolja

zatvor

mučnina i/ili povraćanje

osip

gubitak kose

gubitak teka

umor

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

odstupanja od normalnih vrijednosti testova funkcije jetre

promjene krvnih stanica

napadaji, promjena mentalnog statusa ili budnosti, pospanost, poremećaj ravnoteže, omaglica,

smetenost, zaboravljivost, poteškoće s koncentracijom, osjećaj trnaca, „mravinjanje i bockanje“,

otežan govor ili razumijevanje jezika, tresenje, moždani udar

poremećen ili zamagljen vid, dvostruke slike

gubitak sluha, buka poput zvonjave u ušima

nedostatak zraka, kašalj

rane ili ulceracije u ustima, proljev, bol u trbuhu, žgaravica, otežano gutanje, suha usta

učestalo mokrenje, poteškoće sa zadržavanjem urina ili nevoljno istjecanje urina

nadraženost ili crvenilo kože, suha koža, svrbež

mišićna slabost, bolni zglobovi, bol u mišićima

povišena razina šećera u krvi, gubitak težine

infekcije, infekcija rane, bolno grlo, gljivične infekcije usta, herpes

krvarenje, zadržavanje tekućine, oticanje nogu, krvni ugrušci

alergijska reakcija, vrućica, ozljeda zbog zračenja, oticanje lica, bol, promjena osjeta okusa

tjeskoba, depresija, promjena emocija, nemogućnost usnivanja ili dužeg spavanja.

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

povišeni jetreni enzimi (liječnik će to provjeriti)

palpitacije (neuobičajeno lupanje srca)

simptomi nalik gripi, crvene potkožne mrlje

dugi ili ponavljajući napadaji, nevoljno drhtanje ili brzi, nevoljni pokreti, djelomična oduzetost,

poremećaj koordinacije i ravnoteže, poremećaj osjeta dodira

djelomičan gubitak vida, suhe ili bolne oči

infekcija srednjeg uha, bol ili neugoda u ušima zbog buke, bol u uhu, gluhoća, osjećaj vrtenja

okoline

upala pluća, upala sinusa, bronhitis, začepljen nos, prehlada ili gripa

nadutost trbuha, poteškoće s kontroliranjem stolice, hemoroidi

bol pri mokrenju

ljuštenje kože, povećana osjetljivost kože na sunčevu svjetlost, promjena boje kože, pojačano

znojenje

oštećenje mišića, bol u leđima

niska razina kalija u krvi, povećanje tjelesne težine

herpes zoster, simptomi slični gripi

krvarenje u mozgu, visok krvni tlak, krvni ugrušak u plućima, oticanje

slabost, oticanje lica, drhtanje, poremećaj osjeta okusa, promjene na zubima

impotencija, krvarenje iz rodnice, izostanak ili obilne menstruacije, nadraženost rodnice, bol u

dojkama

promjene raspoloženja, depresija, halucinacije i gubitak pamćenja

promjena boje jezika

promjena osjeta mirisa

žeđ

Slijedeće nuspojave mogu se pojaviti ako uzimate samo temozolomid (bolesnici liječeni zbog tumora

mozga koji se ponovno pojavio ili se proširio)

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

poremećene vrijednosti krvnih pretraga, glavobolja, mučnina ili povraćanje, zatvor, gubitak teka, umor

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

pospanost

,

omaglica, trnci, proljev, bol u trbuhu, loša probava, osip, svrbež, gubitak kose, gubitak

tjelesne težine, vrućica, slabost, drhtanje, loše osjećanje, bol, promjene osjeta okusa, nedostatak zraka.

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

promjene krvnih stanica

Rijetke (mogu se javiti u do 1 na 1000 osoba):

kašalj, infekcije, uključujući infekcije uzročnicima upale pluća.

Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):

crvenilo kože, osip koji svrbi, s uzdignutim žutim ili bijelim kvržicama okruženim crvenom upaljenom

kožom, izbijanje promjena po koži, alergijske reakcije.

Ostale nuspojave:

Često su zabilježeni slučajevi povišenja jetrenih enzima. Manje često su zabilježeni slučajevi

povišenja bilirubina, poteškoća s protokom žuči (kolestaza), hepatitisa i oštećenja jetre, uključujući i

zatajenje jetre sa smrtnim ishodom.

Vrlo rijetko su primijećene nuspojave na plućima s temozolomidom. Kod bolesnika se obično javljaju

nedostatak zraka i kašalj. Primijetite li neki od tih simptoma, obavijestite svog liječnika.

Vrlo rijetko su opaženi slučajevi osipa s oticanjem kože, uključujući dlanove i tabane, ili bolno

crvenilo kože i/ili mjehurići po tijelu ili u ustima. Dogodi li se to, odmah

obavijestite svog liječnika.

U vrlo rijetkim slučajevima, bolesnici koji uzimaju temozolomid i slične lijekove mogu imati malen

rizik od drugih promjena u krvnim stanicama, uključujući leukemiju.

Manje često su prijavljene nove ili reaktivirane (ponavljajuće) infekcije citomegalovirusom te

reaktivirane infekcije virusom hepatitisa B. Manje često su prijavljeni slučajevi infekcija mozga

izazvani virusom herpesa (herpesni meningoencefalitis), uključujući slučajeve sa smrtnim ishodom.

Manje često su prijavljeni slučajevi dijabetes insipidusa. Simptomi dijabetes insipidusa uključuju

obilno mokrenje te osjećaj žeđi.

Prijavljivanje nuspojava

Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.

Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

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

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Temozolomid Accord

Ovaj lijek čuvajte izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.

Nehotično gutanje može biti smrtonosno za djecu.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Bočica

Ne čuvati na temperaturi iznad 25°C.

Čuvati u originalnoj bočici.

Bočicu čuvati čvrsto zatvorenu radi zaštite od vlage.

Vrećica

Ne čuvati na temperaturi iznad 25°C.

Čuvati u originalnom pakiranju radi zaštite od vlage.

Obavijestite svog ljekarnika ako primijetite bilo kakvu promjenu izgleda kapsula.

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 Temozolomid Accord sadrži

Djelatna tvar je temozolomid.

Temozolomid Accord 5 mg tvrde kapsule

: Svaka kapsula sadrži 5 mg temozolomida.

Temozolomid Accord 20 mg tvrde kapsule

: Svaka kapsula sadrži 20 mg temozolomida.

Temozolomid Accord 100

mg tvrde kapsule

: Svaka kapsula sadrži 100 mg temozolomida.

Temozolomid Accord 140 mg tvrde kapsule

: Svaka kapsula sadrži 140 mg temozolomida.

Temozolomid Accord 180 mg tvrde kapsule

: Svaka kapsula sadrži 180 mg temozolomida.

Temozolomid Accord 250 mg tvrde kapsule

: Svaka kapsula sadrži 250 mg temozolomida.

Ostali sastojci su:

Sadržaj kapsule

bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat, vrste A, tartaratna

kiselina, stearatna kiselina.

Ovojnica kapsule

Temozolomid Accord 5 mg tvrde kapsule

: želatina, titanijev dioksid (E171), žuti željezov oksid

(E172), indigo karmin (E132), voda.

Temozolomid Accord 20 mg tvrde kapsule

: želatina, titanijev dioksid (E171), žuti željezov oksid

(E172), voda.

Temozolomid Accord 100 mg tvrde kapsule

: želatina, titanijev dioksid (E171), crveni željezov

oksid (E172), voda.

Temozolomid Accord 140 mg tvrde kapsule

: želatina, titanijev dioksid (E171), indigo karmin

(E132), voda.

Temozolomid Accord 180 mg tvrde kapsule

: želatina, titanijev dioksid (E171), žuti željezov oksid

(E172), crveni željezov oksid (E172), voda.

Temozolomid Accord 250 mg tvrde kapsule

: želatina, titanijev dioksid (E171), voda.

Tinta za označavanje

elak, propilenglikol, crni željezov oksid (E172), kalijev hidroksid

Kako Temozolomid Accord izgleda i sadržaj pakiranja

Temozolomid Accord 5 mg tvrde kapsule imaju bijelo tijelo, zelenu kapicu i crnom tintom otisnutu

oznaku ˝TMZ˝na kapici i ˝5˝na tijelu.

Temozolomid Accord 20 mg tvrde kapsule

imaju bijelo tijelo, žutu kapicu i crnom tintom otisnutu

oznaku ˝TMZ˝na kapici i ˝20˝na tijelu.

Temozolomid Accord 100 mg tvrde kapsule

imaju bijelo tijelo, ružičastu kapicu i crnom tintom

otisnutu oznaku ˝TMZ˝na kapici i ˝100˝na tijelu.

Temozolomid Accord 140 mg tvrde kapsule

imaju bijelo tijelo, plavu kapicu i crnom tintom otisnutu

oznaku ˝TMZ˝na kapici i ˝140˝na tijelu.

Temozolomid Accord 180 mg tvrde kapsule

imaju bijelo tijelo, narančastu kapicu i crnom tintom

otisnutu oznaku ˝TMZ˝na kapici i ˝180˝na tijelu.

Temozolomid Accord 250 mg tvrde kapsule

imaju bijelo tijelo, bijelu kapicu i crnom tintom otisnutu

oznaku ˝TMZ˝na kapici i ˝250˝na tijelu.

Tvrde kapsule dostupne su u smeđim staklenim bočicama koje sadrže 5 ili 20 kapsula.

Svaka kutija sadrži 1 bočicu.

Tvrde kapsule dostupne su u vrećici koja sadrži 1 kapsulu.

Svaka kutija sadrži 5 ili 20 vrećica.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač:

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex,

HA1 4HF,

Ujedinjeno Kraljevstvo

Ova uputa je zadnji puta revidirana u

Drugi izvori informacija

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

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

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

28-8-2018

Temodal (Merck Sharp and Dohme B.V.)

Temodal (Merck Sharp and Dohme B.V.)

Temodal (Active substance: temozolomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5705 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/229/T/83

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

Temomedac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Temomedac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Temomedac (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)5389 of Mon, 06 Aug 2018

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

1-8-2018

Temozolomide SUN (Sun Pharmaceutical Industries Europe BV)

Temozolomide SUN (Sun Pharmaceutical Industries Europe BV)

Temozolomide SUN (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)5216 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Temozolomide Teva (Teva B.V.)

Temozolomide Teva (Teva B.V.)

Temozolomide Teva (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)5214 of Wed, 01 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

10-7-2018

Temozolomide HEXAL (Hexal AG)

Temozolomide HEXAL (Hexal AG)

Temozolomide HEXAL (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4481 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)4480 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety