Kvetiapin Accord

Glavne informacije

  • Zaščiteno ime:
  • Kvetiapin Accord 200 mg tablete s podaljšanim sproščanjem
  • Farmacevtska oblika:
  • tableta s podaljšanim sproščanjem
  • Sestava:
  • kvetiapin 200 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 100 tabletami (10 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

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  • Na voljo v:
  • Kvetiapin Accord 200 mg tablete s podaljšanim sproščanjem
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • kvetiapin

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Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1011-138/2012-8
  • Datum dovoljenje:
  • 26-10-2017
  • EAN koda:
  • 3837000127232
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP-IB/016-09.02.2017

Navodilo za uporabo

Kvetiapin Accord 50 mg tablete s podaljšanim sproščanjem

Kvetiapin Accord 200 mg tablete s podaljšanim sproščanjem

Kvetiapin Accord 300 mg tablete s podaljšanim sproščanjem

Kvetiapin Accord 400 mg tablete s podaljšanim sproščanjem

kvetiapin

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo,

čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte

poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Kako jemati zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Možni neželeni učinki

Shranjevanje zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem in za kaj ga uporabljamo

Zdravilo Kvetiapin Accord

tablete s podaljšanim sproščanjem vsebuje učinkovino, imenovano kvetiapin.

Zdravilo spada v skupino zdravil, ki jih imenujemo antipsihotiki. Zdravilo Kvetiapin Accord tablete s

podaljšanim sproščanjem se uporablja za zdravljenje številnih bolezni, kot so:

• Shizofrenija: slišite ali zaznavate lahko stvari, ki jih ni, verjamete v stvari, ki niso resnične ali ste

neobičajno sumničavi, zaskrbljeni, zmedeni, se čutite krive, ste napeti ali potrti (depresivni).

• Manija: počutite se lahko zelo vznemirjeno, vzhičeno, razburjeno, vzneseno ali hiperaktivno ali imate

slabo presojo, vključno z agresivnim ali motečim vedenjem.

• Bipolarna depresija ali velike epizode depresije pri veliki depresivni motnji: počutite se žalostno ali pa se

počutite potrto (depresivno), krivo, nimate energije, apetita ali ne morete spati.

Ko jemljete zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem za zdravljenje velikih depresivnih

epizod pri veliki depresivni motnji, se jemlje poleg drugega zdravila, s katerim se zdravi ta bolezen.

Vaš zdravnik vam lahko zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem predpisuje tudi po

izboljšanju vašega počutja.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Ne jemljite zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem

če ste alergični na kvetiapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);

če jemljete katero od naštetih zdravil:

nekatera zdravila za zdravljenje okužbe s HIV

azolni antimikotiki (za zdravljenje glivičnih okužb)

eritromicin ali klaritromicin (za zdravljenje okužb)

nefazodon (zdravilo proti depresiji).

Ne jemljite zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, če kaj od zgoraj naštetega velja za

vas. Pred uporabo zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem se posvetujte z zdravnikom ali

farmacevtom.

Opozorila in previdnostni ukrepi

JAZMP-IB/016-09.02.2017

Pred začetkom jemanja zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, se posvetujte z

zdravnikom, farmacevtom ali medicinsko sestro, če:

imate ali ste imeli vi ali kdo v družini težave s srcem, na primer motnje srčnega ritma, oslabelost

srčne mišice ali vnetje srčne mišice, ali pa jemljete zdravila, ki lahko vplivajo na srčni utrip.

imate nizek krvni tlak.

ste imeli možgansko kap, zlasti če ste starejši.

imate težave z jetri.

če ste kadarkoli imeli napad krčev (epileptični napad).

imate sladkorno bolezen ali obstaja tveganje, da se pri vas razvije. Če jo imate, bo zdravnik mogoče

preverjal raven sladkorja v krvi, med zdravljenjem z zdravilom Kvetiapin Accord tablete s

podaljšanim sproščanjem.

veste, da ste v preteklosti imeli nizko raven belih krvnih celic v krvi (kar so lahko ali pa tudi ne

povzročila druga zdravila).

če ste starejša oseba z demenco (poslabšanim delovanjem možganov). Če ste, ne smete jemati

zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, saj lahko skupina zdravil, v katero

sodi tudi Kvetiapin Accord tablete s podaljšanim sproščanjem, poveča tveganje za možgansko kap

ali v nekaterih primerih tveganje za smrt pri starejših osebah z demenco.

ste imeli vi ali kdo v družini kdaj krvne strdke, ker zdravila, kot je to, povezujejo z nastajanjem

krvnih strdkov.

imate ali ste imeli bolezensko stanje, ko med nočnim spanjem za kratek čas nehate dihati (stanje,

imenovano ”spalna apneja”) in jemljete zdravila, ki upočasnjujejo možgansko aktivnost (zaviralce

osrednjega živčnega sistema).

imate ali ste imeli bolezensko stanje nezmožnosti popolne izpraznitve mehurja (zastajanje urina),

imate povečano prostato, zaporo črevesja ali povišan očesni tlak. Ta stanja se včasih pojavijo zaradi

jemanja zdravil (imenovanih ”antiholinergiki”), ki vplivajo na delovanje živčnih celic in se

uporabljajo za zdravljenje nekaterih bolezenskih stanj.

ste v preteklosti zlorabljali alkohol ali drog.

Takoj povejte svojemu zdravniku, če se po tem, ko ste vzeli zdravilo Kvetiapin Accord tablete s

podaljšanim sproščanjem, pojavi kaj od naštetega:

kombinacija povišane telesne temperature, hude togosti mišic, znojenja ali manjše ravni zavedanja

(motnja, imenovana »nevroleptični maligni sindrom«). Morda boste potrebovali takojšnjo

medicinsko pomoč.

nekontrolirani gibi, večinoma mišic obraza ali jezika.

omotičnost ali občutek hude zaspanosti. To lahko pri starejših bolnikih poveča tveganje poškodbe

zaradi nezgode (padca).

napad krčev (epileptični napad).

dolgotrajna in boleča erekcija (priapizem).

Ta stanja lahko povzroči ta vrsta zdravil.

Čimprej povejte svojemu zdravniku, če imate:

povišano telesno temperaturo, gripi podobne simptome, vneto grlo ali katerokoli drugo okužbo, saj

so te lahko posledica zelo nizkega števila belih krvnih celic in lahko zahtevajo ukinitev jemanja

zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem in/ali ustrezno zdravljenje.

zaprtje, skupaj s trajnimi bolečinami v trebuhu ali zaprtje, ki se ni odzvalo na zdravljenje, saj lahko

to vodi v resnejšo zaporo črevesja.

Misli na samomor in poslabšanje depresije

Če ste depresivni, se vam občasno lahko pojavijo misli na samopoškodovanje ali samomor. Po prvi uvedbi

zdravljenja z antidepresivi lahko te misli postanejo še pogostejše, saj ta zdravila začnejo delovati šele čez nekaj

časa, običajno čez dva tedna, včasih pa tudi kasneje. Takšne misli se lahko pogosteje pojavljajo tudi, če zdravilo

nenadoma nehate jemati. Pojav takšnih misli je verjetnejši, če ste mlajša odrasla oseba. Podatki iz kliničnih

preskušanj kažejo, da obstaja pri mlajših odraslih (mlajših od 25 let) z depresijo večje tveganje za pojav

samomorilnega vedenja in/ali samomorilnih misli.

Če začnete kadarkoli razmišljati o samopoškodovanju ali samomoru, se nemudoma posvetujte s svojim

zdravnikom ali poiščite pomoč v najbližji bolnišnici. Mogoče vam bo v pomoč, če za težave z depresijo poveste

JAZMP-IB/016-09.02.2017

sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo. Prosite ga lahko tudi, da naj vas opozori,

če meni, da se je depresija poslabšala ali ga skrbijo spremembe v vašem vedenju.

Povečanje telesne mase

Pri bolnikih, ki so jemali zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem, so opazili povečanje

telesne mase. Vi in vaš zdravnik morata redno preverjati vašo telesno maso.

Otroci in mladostniki

Otroci in mladostniki, mlajši od 18 let, zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem ne smejo

jemati.

Druga zdravila in zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo

zdravilo.

Ne jemljite zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, če jemljete katero od naštetih zdravil:

nekatera zdravila za zdravljenje okužbe s HIV.

azolne antimikotike (za zdravljenje glivičnih okužb).

eritromicin ali klaritromicin (za zdravljenje okužb).

nefazodon (zdravilo proti depresiji).

Povejte svojemu zdravniku, če uporabljate katero od naslednjih zdravil:

zdravila za zdravljenje epilepsije (kot sta fenitoin ali karbamazepin).

zdravila za zdravljenje zvišanega krvnega tlaka.

barbiturate (za zdravljenje nespečnosti).

tioridazin ali litij (drugi izmed antipsihotikov).

zdravila, ki vplivajo na vaš srčni utrip, na primer zdravila, ki lahko povzročijo neravnovesje elektrolitov

(nizke ravni kalija ali magnezija), kot so diuretiki (zdravila za odvajanje vode) ali nekateri antibiotiki

(zdravila za zdravljenje okužb).

zdravila, ki povzročajo zaprtje.

zdravila

(imenovana

“antiholinergiki”),

vplivajo

delovanje

živčnih

celic

uporabljajo

zdravljenje nekaterih bolezenskih stanj.

Preden prenehate jemati katerokoli od zdravil, ki jih jemljete, se najprej posvetujte s svojim zdravnikom.

Zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem skupaj s hrano, pijačo in alkoholom

Hrana lahko vpliva na delovanje zdravila Kvetiapin Accord, tablete s podaljšanim sproščanjem, zato

tablete zaužijte vsaj eno uro pred obrokom ali pred spanjem.

Bodite pozorni na to, koliko alkohola popijete. Skupen učinek zdravila Kvetiapin Accord tablete s

podaljšanim sproščanjem in alkohola lahko povzroči zaspanost.

Med zdravljenjem z zdravilom Kvetiapin Accord tablete s podaljšanim sproščanjem ne pijte grenivkinega

soka. Grenivkin sok lahko vpliva na delovanje zdravila.

Nosečnost, dojenje in plodnost

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali

farmacevtom, predem vzamete to zdravilo. Zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem ne

smete jemati med nosečnostjo, razen če ste se o tem pogovorili s svojim zdravnikom. Zdravila Kvetiapin

Accord tablete s podaljšanim sproščanjem ne smete jemati, če dojite.

Pri novorojenčkih mater, ki so v zadnjem trimesečju (zadnje tri mesece nosečnosti) jemale zdravilo Kvetiapin

Accord tablete s podaljšanim sproščanjem, se lahko pojavijo naslednji simptomi, ki lahko predstavljajo

odtegnitev: tresenje, mišična togost in/ali šibkost, zaspanost, nemir, težave z dihanjem in težave s hranjenjem.

Če pri otroku opazite kateregakoli od teh simptomov, se boste morali morda posvetovati z zdravnikom.

Vpliv na sposobnost upravljanja vozil in strojev

Po jemanju tega zdravila se lahko počutite zaspani. Ne vozite in ne upravljajte z orodji ali stroji, dokler ne

poznate vpliva teh tablet na vas.

Zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem vsebuje laktozo

JAZMP-IB/016-09.02.2017

Zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem vsebuje laktozo, ki je vrsta sladkorja. Če vam je

zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim

zdravnikom.

Vpliv na rezultate testov zdravil v urinu

Uporaba zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem lahko pri testiranju na prisotnost zdravil

v urinu povzroči lažno pozitivne rezultate za metadon in nekatera druga zdravila proti depresiji, imenovana

triciklični antidepresivi, ko se uporablja določen način testiranja, kljub temu, da morda ne jemljete metadona ali

tricikličnih antidepresivov.

Če pride do tega, se lahko opravi bolj specifične preiskave.

3.

Kako jemati zdravilo Kvetiapin Accord

tablete s podaljšanim sproščanjem

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste negotovi, se posvetujte

z zdravnikom ali s farmacevtom.

Začetni odmerek vam bo predpisal vaš zdravnik. Vzdrževalni odmerek (dnevni odmerek) bo odvisen od bolezni

in vaših potreb, vendar je običajno med 150 mg in 800 mg.

Tablete boste jemali enkrat na dan.

Tablet ne delite, žvečite ali drobite.

Tablete zaužijte cele z nekaj vode.

Ne jemljite tablet sočasno s hrano (vzemite jih vsaj eno uro pred obrokom ali pred spanjem, kot

vam bo povedal zdravnik).

Med zdravljenjem z zdravilom Kvetiapin Accord tablete s podaljšanim sproščanjem ne pijte

grenivkinega soka, saj lahko vpliva na način delovanja zdravila.

Z jemanjem zdravila ne smete prenehati, tudi če se počutite dobro, razen če vam tako naroči vaš

zdravnik.

Težave z jetri

Če imate težave z jetri, bo zdravnik morda spremenil vaš odmerek.

Starejši ljudje

Če ste starejša oseba, vam lahko zdravnik spremeni odmerek.

Uporaba pri otrocih in mladostnikih

Otroci in mladostniki mlajši od 18 let ne smejo jemati zdravila Kvetiapin Accord tablete s podaljšanim

sproščanjem.

Če ste vzeli večji odmerek zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, kot bi smeli

Če ste vzeli večji odmerek zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem, kot ga je predpisal

zdravnik, se lahko počutite zaspano, omotično in občutite nenormalno bitje srca. Takoj se obrnite na svojega

zdravnika ali najbližjo bolnišnico. Zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem vzemite s

seboj.

Če ste pozabili vzeti zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite. Če je že skoraj čas, da vzamete naslednji

odmerek, počakajte do takrat. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.

Če ste prenehali jemati zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Pri nenadnem prenehanju jemanja zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem se lahko

pojavijo nespečnost (insomnija), občutek slabosti (navzea) ali pa lahko dobite glavobol, drisko, bruhate,

postanete omotični ali razdražljivi. Zdravnik vam bo svetoval, da pred opustitvijo zdravila odmerek zmanjšujete

postopoma.

Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko

sestro.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

JAZMP-IB/016-09.02.2017

Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):

omotica (lahko povzroči padce), glavobol, suha usta,

občutek zaspanosti (med nadaljevanjem jemanja zdravila Kvetiapin Accord tablete s podaljšanim

sproščanjem bo morda izginil) (lahko povzroči padce),

odtegnitveni simptomi (simptomi, ki se lahko pojavijo, ko prenehate jemati kvetiapin) vključujejo

nespečnost (insomnijo), občutek slabosti (navzeo), glavobol, drisko, bruhanje, omotičnost in

razdražljivost. Priporočljivo je postopno prenehanje zdravljenja, ki naj traja najmanj en ali dva tedna.

pridobivanje na telesni masi,

nenormalni mišični gibi, vključno s težavami pri začenjanju mišičnih gibov, tresenjem, občutkom nemira

ali togostjo mišic brez bolečin.

spremembe v količini določenih maščob (trigliceridov in skupnega holesterola).

Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):

hitro bitje srca,

občutek razbijanja, hitrega bitja ali preskakovanja bitja srca (ali izpuščenih utripov srca),

zaprtost, težave z želodcem (slaba prebava),

občutek šibkosti,

otekanje rok ali nog,

nizek krvni tlak ob vstajanju. Zaradi tega se lahko počutite omotične ali omedlite (kar lahko povzroči

padce).

zvišana raven sladkorja v krvi,

zamegljen vid,

nenavadne sanje in nočne more,

občutek lakote (večji kot običajno)

občutek razdražljivosti,

motnje govora in jezika,

misli na samomor in poslabšanje depresije,

kratka sapa,

bruhanje (predvsem pri starejših),

zvišana telesna temperatura,

spremembe v količini ščitničnih hormonov v krvi,

znižana količina nekaterih vrst krvnih celic,

povečana količina jetrnih encimov, izmerjenih v krvi,

povečana količina hormona prolaktina v krvi. Povečanje količine hormona prolaktina v krvi

lahko v redkih primerih povzroči naslednje: moškim in ženskam otekajo prsi in nepričakovano

začne nastajati mleko,

ženske nimajo menstruacije ali jo imajo neredno.

Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):

krči ali epileptični napadi,

alergijske reakcije, ki lahko vključujejo izbočene otekline (izpuščaje), otekanje kože in predela okoli ust,

neprijeten občutek v nogah (imenovan tudi sindrom nemirnih nog),

težave s požiranjem,

nekontrolirani gibi, večinoma mišic obraza ali jezika,

motnje na področju spolnosti,

sladkorna bolezen,

sprememba električne aktivnosti srca, kar je razvidno iz elektrokardiograma (podaljšanje intervala QT),

počasnejši srčni utrip od običajnega, ki se lahko pojavi na začetku zdravljenja in ki je lahko povezan z

nizkim krvnim tlakom in omedlevico,

oteženo uriniranje,

omedlevica (lahko povzroči padce),

zamašen nos,

znižana količina rdečih krvnih celic,

znižana količina natrija v krvi,

poslabšanje obstoječe sladkorne bolezni.

Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):

kombinacija povišane telesne temperature (vročina), znojenja, togih mišic, občutka hude zaspanosti ali

omedlevice (motnja, ki se imenuje “nevroleptični maligni sindrom”),

porumenelost kože in oči (zlatenica),

JAZMP-IB/016-09.02.2017

vnetje jeter (hepatitis),

dolgotrajna in boleča erekcija (priapizem),

otekanje prsi in nepričakovano proizvajanje mleka (galaktoreja),

menstrualne motnje,

krvni strdki v žilah, zlasti v nogah (simptomi, ki vključujejo oteklost, bolečino in pordelost nog), ki lahko

potujejo po krvnih žilah v pljuča, kjer povzročijo bolečino v prsnem košu in težave z dihanjem. Če

opazite kateregakoli od the simptomov, takoj poiščite zdravniško pomoč.

hoja, govorjenje in uživanje hrane med spanjem ter izvajanje drugih dejavnosti, medtem ko spite,

znižana telesna temperatura (hipotermija),

vnetje trebušne slinavke,

bolezen (ki se imenuje "presnovni sindrom"), pri kateri se sočasno pojavijo 3 ali več od naslednjih

motenj: povečanje maščobe okrog trebuha, znižanje vrednosti "dobrega holesterola" (HDL-C), zvišanje

vrednosti maščob v krvi, imenovanih trigliceridi, visok krvni tlak in povišan krvni sladkor,

kombinacija povišane telesne temperature (vročina), gripi podobnih simptomov, vnetega grla ali

katerekoli druge okužbe, ki povzroči znižanje količine belih krvnih celic, stanje, ki se imenuje

agranulocitoza,

zapora črevesja,

zvišana količina kreatin fosfokinaze (snov v mišicah) v krvi.

Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):

hud izpuščaj, mehurji ali rdeče lise na koži,

huda alergijska reakcija (imenovana anafilaksija), ki lahko povzroči težave z dihanjem ali šok,

hitro otekanje kože, običajno okoli oči, ustnic in grla (angioedem),

resne kožne reakcije z mehurjastimi izpuščaji na koži, ustih, očeh in genitalijah (Stevens-Johnsonov

sindrom),

neustrezno izločanje hormona, ki nadzira volumen urina,

razgradnja mišičnega tkiva in bolečine v mišicah (rabdomioliza).

Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)

kožni izpuščaj z nepravilnimi rdečimi pikami (multiformni eritem),

resna, nenadna alergijska reakcija s simptomi, kot so povišana telesna temperatura in mehurji na koži ter

lupljenje kože (toksična epidermalna nekroliza),

pri novorojenčkih mater, ki so med nosečnostjo jemale zdravilo Kvetiapin Accord tablete s podaljšanim

sproščanjem, se lahko pojavijo odtegnitveni simptomi

Skupina zdravil, v katero sodi zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem, lahko povzroči

težave s srčnim ritmom, ki so lahko resne, v hudih primerih pa tudi smrtne.

Nekateri neželeni učinki so vidni šele s preiskavo krvi. Ti vključujejo spremembe količine nekaterih maščob

(trigliceridi in skupni holesterol) ali sladkorja v krvi, spremembe vrednosti ščitničnih hormonov v krvi, zvišane

vrednosti jetrnih encimov, zmanjšanje števila nekaterih vrst krvnih celic, zmanjšanje števila rdečih krvnih celic

(eritrocitov), zvišanje vrednosti kreatin fosfokinaze v krvi (snov v mišicah), zmanjšanje količine natrija v krvi

in povečanje količine hormona prolaktina v krvi. Povečanje količine hormona prolaktina lahko v redkih

primerih povzroči naslednje:

moškim in ženskam otekajo prsi in nepričakovano začne nastajati mleko.

ženske nimajo menstruacije ali jo imajo neredno.

Vaš zdravnik vas bo lahko občasno napotil, da opravite preiskavo krvi.

Neželeni učinki pri otrocih in mladostnikih:

Enaki neželeni učinki, ki se lahko pojavijo pri odraslih, se lahko pojavijo tudi pri otrocih in mladostnikih.

Naslednje neželene učinke so pogosteje opazili pri otrocih in mladostnikih kot pri odraslih ali jih pri odraslih

sploh niso opazili:

Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):

povečanje količine hormona, imenovanega prolaktin, v krvi. Povečanje količine hormona, imenovanega

prolaktin, lahko v redkih primerih povzroči:

JAZMP-IB/016-09.02.2017

fantom in deklicam otekajo prsi in nepričakovano začne nastajati mleko.

deklice nimajo menstruacije ali jo imajo neredno.

zvečan apetit,

bruhanje,

nenormalni mišični gibi, vključno s težavami pri začenjanju mišičnih gibov, tresenjem, občutkom nemira

ali togostjo mišic brez bolečin,

povišan krvni tlak.

Pogosti neželeni učinki (pojavijo se pri manj kot 1 od 10 bolnikov):

občutek šibkosti, omedlevica (lahko povzroči padce),

zamašen nos,

občutek razdraženosti.

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.

Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko

poročate tudi neposredno na

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Sektor za farmakovigilanco

Nacionalni center za farmakovigilanco

Slovenčeva ulica 22

SI-1000 Ljubljana

Tel: +386 (0)8 2000 500

Faks: +386 (0)8 2000 510

e-pošta: h-farmakovigilanca@jazmp.si

spletna stran: www.jazmp.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.

5.

Shranjevanje zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki, škatli ali

pretisnem omotu poleg oznake "EXP". Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja zdravila, ki

ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

Za shranjevanje tega zdravila niso potrebna posebna navodila.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem

Zdravilna učinkovina je kvetiapin. Ena tableta zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem

vsebuje 50 mg, 200 mg, 300 mg ali 400 mg kvetiapina (v obliki kvetiapinijevega fumarata).

Druge sestavine zdravila (pomožne snovi) so:

Jedro tablete: laktoza monohidrat, hipromeloza, natrijev klorid, povidon K 30, smukec in magnezijev stearat.

50 mg tableta vsebuje tudi silicizirano mikrokristalno celulozo (mikrokristalna celuloza in koloidni brezvodni

silicijev dioksid).

Obloga tablete: titanov dioksid (E171), makrogol 400 (E1521). 50 mg tableta vsebuje tudi polivinilalkohol

(E1203), smukec (E553b) in rdeči železov oksid (E172). 50 mg, 200 mg in 300 mg tablete vsebujejo tudi

rumeni železov oksid (E172). 200 mg, 300 mg in 400 mg tablete vsebujejo tudi hipromelozo 6 cP (E464).

Izgled zdravila Kvetiapin Accord tablete s podaljšanim sproščanjem in vsebina pakiranja

Zdravilo Kvetiapin Accord 50 mg tablete s podaljšanim sproščanjem so

okrogle, obojestransko izbočene,

filmsko obložene tablete breskove barve z vtisnjenim napisom "Q50" na eni strani in brez vtisnjene oznake na

drugi strani.

Zdravilo Kvetiapin Accord 200 mg tablete s podaljšanim sproščanjem so

rumene, okrogle, obojestransko

izbočene, filmsko obložene tablete z vtisnjenim napisom "I2" na eni strani in brez vtisnjene oznake na drugi

strani. Premer 200 mg tablete je približno 9,6 mm.

JAZMP-IB/016-09.02.2017

Zdravilo Kvetiapin Accord 300 mg tablete s podaljšanim sproščanjem so bledorumene, okrogle, obojestransko

izbočene, filmsko obložene tablete z vtisnjenim napisom "Q300" na eni strani in brez vtisnjene oznake na drugi

strani. Premer 300 mg tablete je približno 11,2 mm.

Zdravilo Kvetiapin Accord 400 mg tablete s podaljšanim sproščanjem so bele, okrogle, obojestransko izbočene,

filmsko obložene tablete z vtisnjenim napisom "I4" na eni strani in brez vtisnjene oznake na drugi strani. Premer

400 mg tablete je približno 12,8 mm.

Pretisni omot iz PVC/PVdC/aluminija:

Za zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem 200 mg, 300 mg in 400 mg so registrirane

velikosti pakiranja 10, 30, 50, 60 in 100 tablet na škatlo.

Pretisni omot iz PVC/PVdC/aluminija ali OPA/aluminija/PVC – aluminija:

Za zdravilo Kvetiapin Accord tablete s podaljšanim sproščanjem 50 mg so registrirane velikosti pakiranja 6, 10,

20, 28, 30, 50, 60, 90 in 100 tablet na škatlo.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila Kvetiapin Accord

tablete s podaljšanim sproščanjem

Rp – Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Accord Healthcare Limited,

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF,

Velika Britanija

Izdelovalci

Accord Healthcare Limited,

Sage House, 319, Pinner Road, North Harrow,

Middlesex, HA1 4HF,

Velika Britanija

Pharmacare Premium Ltd.,

HHF 003, Hal Far Industrial Estate, Birzebbugia,

BBG 3000,

Malta

GAP S.A.,

46, Agissilaou str.

Agios Dimitrios, Athens

Post Code:17341

Grčija

Kvetiapin Accord 50 mg tablete s podaljšanim sproščanjem:

ARROW GENERIQUES- LYON,

26 avenue Tony Garnier, LYON, 69007,

Francija

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Ime države članice

Ime zdravila

Avstrija

Quetiapine Accord 50mg/200 mg/300mg/400mg Retardtabletten

Bolgarija

Quetiapine Accord 50mg/200mg/300mg/400mg таблетки с удължено освобождаване

Ciper

Quetiapine Accord 50mg/200mg/300mg/400mg δισκία παρατεταμένης αποδέσμευσης

Češka republika

Quetiapine Accord 50mg/200mg/300mg/400mg tablety s prodlouženým uvolňováním

JAZMP-IB/016-09.02.2017

Nemčija

Quetiapin Accord 50mg/200mg/300mg/400mg Retardtabletten

Danska

Quetiapin Accord 50mg/200mg/300mg/400mg Depottabletter

Estonija

Quetiapine Accord

Grčija

Matepil 50 mg/200mg/ 300mg/ 400mg δισκία παρατεταμένης αποδέσμευσης

Španija

Quetiapine Accord 50mg/200mg/300mg/400mg comprimidos de liberación prolongada

Finska

Quetiapine Accord 50mg/200mg/300mg/400mg depottabletit

Francija

QUETIAPINE ARROW LP 50 mg, comprimés à libération prolongée

Madžarska

Quetiapine Accord 50mg/200mg/300mg/400mg retard tabletta

Irska

Notiabolfen XL 50mg/200 mg/ 300 mg/ 400 mg prolonged-release Tablet

Italija

Quetiapina Accord Healthcare 50 mg/200mg/ 300mg/ 400mg compresse a rilascio

prolungato

Latvija

Quetiapine Accord 50mg/200mg/300mg/400mg

ilgstošās darbības apvalkotās tabletes

Litva

Quetiapine Accord 50mg/200mg/300mg/400mg pailginto atpalaidavimo tabletės

Malta

Atrolak XL 50mg/200 mg/ 300 mg/ 400 mg prolonged-release Tablet

Nizozemska

Quetiapine Accord 50mg/200mg/300mg/400mg tabletten met verlengde afgifte

Norveška

Quetiapine Accord

Poljska

Atrolak

Portugalska

Quetiapina Accord 50mg/200mg/300mg/400mg comprimidos de libertação prolongada

Romunija

Quetiapină Accord 50mg/200 mg/300 mg/400 mg comprimate cu eliberare prelungită

Švedska

Quetiapine Accord 50mg/200mg/300mg/400mg depottabletter

Slovenija

Kvetiapin Accord 50mg, 200mg, 300mg, 400mg tablete s podaljšanim sproščanjem

Slovaška

Quetiapine Accord 50mg/200mg/300mg/400mg Filmom obalené tablety s predĺženým

uvoľňovaním

Velika Britanija

Atrolak XL 50mg/200 mg/ 300 mg/ 400 mg prolonged-release Tablet

Navodilo je bilo nazadnje revidirano dne 09.02.2017.

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Health Canada

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

18-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

15-5-2018

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Accord Healthcare Limited)

Pramipexole Accord (Active substance: pramipexole) - Centralised - Yearly update - Commission Decision (2018)2995 of Tue, 15 May 2018

Europe -DG Health and Food Safety