Volqer 200 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Volqer 200 mg tablete s produljenim oslobađanjem
  • Doziranje:
  • 200 mg
  • Farmaceutski oblik:
  • tableta s produljenim oslobađanjem
  • Sastav:
  • Urbroj: jedna tableta s produljenim oslobađanjem sadrži 200 mg kvetiapina (u obliku kvetiapinfumarata)
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Salutas Pharma GmbH, Barleben, Njemačka; Pharmathen International S.A., Rodopi, Grčka; Pharmathen S.A., Pallini Attikis, Atena

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Volqer 200 mg tablete s produljenim oslobađanjem
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-866394670-01]; 30 tableta u blisteru, u kutiji [HR-H-866394670-02]; 50 tableta u blisteru, u kutiji [HR-H-866394670-03]; 56 tableta u blisteru, u kutiji [HR-H-866394670-04]; 60 tableta u blisteru, u kutiji [HR-H-866394670-05]; 100 tableta u blisteru, u kutiji [HR-H-866394670-06]; 60 tableta u bočici, u kutiji [HR-H-866394670-07]; 120 tableta u bočici, u kutiji [HR-H-866394670-08] Urbroj: 381-12-01/70-15-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-866394670
  • Datum autorizacije:
  • 30-10-2015
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Volqer 50 mg tablete s produljenim oslobaĎanjem

Volqer 200 mg tablete s produljenim oslobaĎanjem

Volqer 300 mg tablete s produljenim oslobaĎanjem

Volqer 400 mg tablete s produljenim oslobaĎanjem

kvetiapin

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati lijek jer sadrži Vama važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

1. Što je Volqer i za što se koristi

2. Što morate znati prije nego počnete uzimati Volqer

3. Kako uzimati Volqer

4. Moguće nuspojave

5. Kako čuvati Volqer

6. Sadržaj pakiranja i druge informacije

1.

Što je Volqer i za što se koristi

Volqer sadrži djelatnu tvar kvetiapin. Ona pripada skupini lijekova koju nazivamo antipsihotici.

Volqer se može koristiti za liječenje različitih bolesti, kao što su:

bipolarna depresija i velike depresivne epizode u velikom depresivnom poremećaju: stanje u

kojem stalno možete osjećati tugu ili se možete osjećati potišteno, imati osjećaj krivnje,

nedostatak energije, gubitak apetita ili nesanicu.

manija: stanje u kojem se možete osjećati uzbuđeno, ushićeno, uznemireno, entuzijastično ili

hiperaktivno; ili možete imati poremećaj prosuđivanja što uključuje agresivno ili razorno

ponašanje.

shizofrenija: stanje u kojem možete čuti ili osjećati nešto što ne postoji, vjerovati u nešto što nije

istinito ili osjećati neobičnu sumnjičavost, tjeskobu, smetenost, krivnju, napetost ili potištenost.

Kada se Volqer

koristi za liječenje velikih depresivnih epizoda u velikom depresivnom poremećaju,

on se uzima kao dodatna terapija uz drugi lijek za liječenje ove bolesti.

Liječnik može nastaviti s propisivanjem Volqera čak i kada se osjećate bolje.

2.

Što morate znati prije nego počnete uzimati Volqer

Nemojte uzimati Volqer

ako ste alergični na kvetiapin ili bilo koji drugi sastojak ovog lijeka (navedeno u dijelu 6)

ako uzimate bilo koji od sljedećih lijekova:

neke lijekove za liječenje HIV infekcija

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lijekove iz skupine azola (za liječenje gljivičnih infekcija)

eritromicin ili klaritromicin (lijekovi za liječenje bakterijskih infekcija)

nefazodon (lijek za liječenje depresije).

Ako se bilo što od gore navedenog odnosi na Vas, nemojte uzimati Volqer. Ako niste sigurni, prije

uzimanja Volqera posavjetujte se sa svojim liječnikom ili ljekarnikom.

Upozorenja i mjere opreza

Prije uzimanja Volqera, obavijestite svog liječnika ako:

Vi, ili netko iz Vaše obitelji, ima ili je imao bilo kakve poteškoće sa srcem, na primjer

poremećaje srčanog ritma, slabljenje srčanog mišića ili upalu srca, ili ako uzimate bilo koje

lijekove koji mogu utjecati na rad Vašeg srca.

imate nizak krvni tlak.

ste imali moždani udar, osobito ako ste starije životne dobi.

imate poteškoće s jetrom.

ste ikada imali napadaj (konvulzije).

imate šećernu bolest ili rizik da od nje obolite. Ako je tako, liječnik Vam može provjeravati

razinu šećera u krvi za vrijeme uzimanja Volqera.

Vam je poznato da ste u prošlosti imali sniženi broj bijelih krvnih stanica (što je moglo ili nije

moralo biti uzrokovano uzimanjem drugih lijekova).

ste starije životne dobi i imate demenciju (poremećaj funkcije mozga). U tom slučaju ne biste

trebali uzimati Volqer jer skupina lijekova kojoj pripada Volqer može povećati rizik od

moždanog udara, ili u nekim slučajevima rizik od smrtnog ishoda, u osoba starije životne dobi s

demencijom.

Vi, ili netko iz Vaše obitelji u povijesti bolesti ima podatak o pojavi krvnih ugrušaka, jer su

lijekovi poput ovog povezani sa stvaranjem krvnih ugrušaka.

ako imate ili ste imali stanje kada ste prestali disati na kraće periode tijekom Vašeg normalnog

noćnog sna (tzv. „apneja u snu“) i uzimate lijekove koji usporavaju normalnu aktivnost mozga

(„depresori“).

ako imate ili ste imali stanje kada ne možete u potpunosti isprazniti svoj mjehur (zadržavanje

urina), imate uvećanu prostatu, začepljenje crijeva ili povišen očni tlak. Ova stanja su ponekad

uzrokovana lijekovima (tzv. „antikolinergicima“) koji utječu na način funkcioniranja živčanih

stanica kako bi se liječila određena medicinska stanja.

ako imate ili ste imali problema s alkoholom ili zlouporabom droga.

Odmah obavijestite svog liječnika ako nakon uzimanja Volqera primijetite bilo što od

navedenog:

kombinaciju vrućice, jake ukočenosti mišića, znojenja ili smanjenja stupnja svijesti (poremećaj

pod nazivom „neuroleptički maligni sindrom”). Možda će biti potrebno hitno medicinsko

liječenje.

nekontrolirane pokrete, uglavnom lica ili jezika.

omaglicu ili jaki osjećaj pospanosti. To može povećati rizik od ozljeda zbog nezgode (pad) u

starijih bolesnika.

napadaje (konvulzije).

dugotrajnu i bolnu erekciju (prijapizam).

Navedena stanja mogu biti uzrokovana ovom skupinom lijekova.

Što prije obavijestite svog liječnika ako imate:

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vrućicu, simptome nalik gripi, grlobolju ili bilo koju drugu infekciju jer to može biti posljedica

vrlo niskog broja bijelih krvnih stanica, zbog čega ćete možda morati prestati uzimati Volqer i/ili

primiti liječenje.

zatvor praćen bolovima u trbuhu koji ne prolaze, ili zatvor koji ne odgovara na liječenje jer to

može dovesti do ozbiljnije blokade crijeva.

Misli o samoubojstvu i pogoršanje Vaše depresije

Ako ste depresivni, ponekad Vam se mogu pojaviti misli o samoozljeđivanju ili samoubojstvu. Do

toga češće može doći na početku liječenja, jer ovoj skupini lijekova treba određeno vrijeme da počnu

djelovati, obično oko dva tjedna, ali ponekad i dulje.

Ove misli mogu biti češće i pri naglom prestanku uzimanja lijeka. Također, mogu biti češće i kod

mlađih odraslih osoba. Informacije iz kliničkih ispitivanja pokazuju da se povećani rizik od pojave

misli o samoubojstvu i/ili suicidalnog ponašanja javlja u mlađih odraslih osoba u dobi ispod 25

godina, koje boluju od depresije.

Ako Vam se u bilo koje vrijeme pojave misli o samoozljeđivanju ili samoubojstvu, odmah se javite

svom liječniku ili otiđite u najbližu bolnicu. Možda će Vam biti od pomoći ako kažete rođaku ili

bliskom prijatelju da ste depresivni te ih zamolite da pročitaju ovu uputu. Također, možete ih zamoliti

da Vam kažu ako misle da se Vaša depresija pogoršava, ili ako su zabrinuti zbog promjena u Vašem

ponašanju.

Porast tjelesne težine

Porast tjelesne težine je opažen u bolesnika koji uzimaju Volqer. I Vi i Vaš liječnik trebate redovito

nadzirati Vašu tjelesnu težinu.

Djeca i adolescenti

Volqer se ne smije primjenjivati kod djece i adolescenata mlađih od 18 godina.

Drugi lijekovi i Volqer

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli

ili biste mogli uzeti bilo koje

druge lijekove.

Ne uzimajte Volqer ako uzimate bilo koji od sljedećih lijekova:

neke lijekove za liječenje HIV infekcija.

lijekove iz skupine azola (za liječenje gljivičnih infekcija).

eritromicin ili klaritromicin (lijekovi za liječenje infekcija).

nefazodon (lijek za liječenje depresije).

Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova:

lijekove za epilepsiju (kao što su fenitoin ili karbamazepin).

lijekove za liječenje povišenog krvnog tlaka.

barbiturate (lijekovi za liječenje poremećaja spavanja).

tioridazin ili litij (također antipsihotici).

lijekove koji utječu na rad srca, na primjer, lijekove koji mogu uzrokovati neravnotežu elektrolita

(niske razine kalija ili magnezija) kao što su diuretici (lijekovi za izmokravanje) ili određeni

antibiotici (lijekovi za liječenje infekcija).

lijekove koji mogu uzrokovati zatvor.

lijekove (tzv. „antikolinergike“) koji utječu na način funkcioniranja živčanih stanica kako bi se

liječila određena medicinska stanja.

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Prije nego što prestanete uzimati bilo koji od lijekova koje inače uzimate, porazgovarajte sa svojim

liječnikom.

Volqer s hranom, pićem i alkoholom

hrana može utjecati na Volqer i zbog toga morate uzeti svoje tablete najmanje jedan sat prije

obroka ili prije spavanja.

budite oprezni s količinom alkohola koju uzimate. Razlog je što Vas kombinirani utjecaj Volqera

i alkohola može učiniti pospanima.

nemojte piti sok od grejpa za vrijeme uzimanja Volqera. Sok od grejpa može utjecati na

djelovanje lijeka.

Trudnoća, dojenje i plodnost

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Ne smijete uzimati Volqer za vrijeme trudnoće, ukoliko to prethodno nije raspravljeno s Vašim

liječnikom. Volqer se ne smije uzimati ako dojite.

Sljedeći simptomi, koji mogu biti znakovi ustezanja (prekida primjene lijeka), mogu se javiti kod

novorođenčadi majki koje su uzimale Volqer u zadnjem tromjesečju (zadnja tri mjeseca) trudnoće:

tresavica, ukočenost i/ili slabost mišića, pospanost, uznemirenost, poteškoće s disanjem i otežano

hranjenje. Ako Vaše dijete razvije bilo koji od tih simptoma, morate se javiti liječniku.

Upravljanje vozilima i strojevima

Vaše tablete Vas mogu učiniti pospanima. Ne vozite i ne rukujte alatima ili strojevima sve dok ne

utvrdite kako ove tablete djeluju na Vas.

Učinak na probirne testove na lijekove u urinu

Ukoliko ste podvrgnuti probirnim testovima na lijekove u urinu, uzimanje Volqera može uzrokovati

pozitivne rezultate na metadon ili određene lijekove protiv depresije koji se zovu triciklički

antidepresivi kada se koriste određene metode testiranja, iako Vi možda ne uzimate metadon ili

tricikličke antidepresive. Ako se to dogodi, može se koristiti specifičniji test.

Volqer sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite određene šećere, posavjetujte se s njim prije uzimanja

ovog lijeka.

3.

Kako uzimati Volqer

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

liječnikom ili ljekarnikom ako niste sigurni.

O početnoj dozi lijeka odlučit će Vaš liječnik. Doza održavanja (dnevna doza) će ovisiti o Vašoj

bolesti i potrebama, no obično će se kretati između 150 i 800 mg.

svoje tablete ćete uzimati jednom dnevno.

tablete ne smijete lomiti, žvakati ili drobiti.

tablete progutajte cijele, s nešto vode.

svoje tablete uzmite bez hrane (najmanje jedan sat prije obroka ili prije spavanja, liječnik će Vam

reći kada).

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tijekom liječenja Volqerom nemojte piti sok od grejpa, jer može utjecati na djelovanje lijeka u

organizmu.

čak i ako se osjećate bolje, nemojte prestati uzimati tablete sve dok Vam to ne preporuči liječnik.

Bolesnici s jetrenim tegobama

Ako imate jetrenih tegoba, liječnik Vam može promijeniti dozu.

Stariji bolesnici

Ako ste u starijoj životnoj dobi, liječnik Vam može dati nižu dozu.

Primjena u djece i adolescenata (mlađih od 18 godina)

Volqer se ne smije primjenjivati kod djece i adolescenata mlađih od 18 godina.

Ako uzmete više Volqera nego što ste trebali

Ako uzmete više Volqera nego što Vam je propisao liječnik, mogli biste osjetiti pospanost, omaglicu i

nepravilan rad srca. Odmah zatražite savjet liječnika ili najbliže bolnice. Ponesite Volqer tablete sa

sobom.

Ako ste zaboravili uzeti Volqer

Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite. Ako je uskoro vrijeme za sljedeću dozu,

pričekajte do tada. Ne uzimajte dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Volqer

Ako naglo prestanete uzimati Volqer, mogli biste osjetiti nesanicu, ili mučninu, ili biste mogli imati

glavobolju, proljev, povraćanje, omaglicu ili biti razdražljivi.

Liječnik Vam može savjetovati da postupno smanjujete dozu lijeka, prije potpunog prestanka

uzimanja.

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

4.

Moguće nuspojave

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

Vrlo često (mogu se javiti kod više od 1 na 10 osoba):

omaglica (može dovesti do padova), glavobolja ili suha usta.

osjećaj pospanosti koji nastavkom uzimanja Volqera i tokom vremena može nestati (može dovesti

do padova).

simptomi ustezanja (simptomi koji se javljaju kod prekida uzimanja Volqera) uključuju

nemogućnost spavanja (nesanica), mučninu, glavobolju, proljev, povraćanje, omaglicu i

razdražljivost. Savjetuje se postupan prekid liječenja tijekom najmanje 1 do 2 tjedna.

dobivanje na težini.

abnormalni pokreti mišića. Oni uključuju otežano pokretanje mišića, tresavicu, osjećaj nemira ili

ukočenost mišića bez bolova.

promjene u količini određenih masnoća (triglicerida i ukupnog kolesterola).

Često (mogu se javiti kod 1 na 10 osoba):

ubrzani otkucaji srca.

osjećaj da Vaše srce lupa, vrlo brzo radi ili preskače otkucaje.

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zatvor ili želučane tegobe (poremećaj probave).

osjećaj slabosti.

oticanje ruku ili nogu.

nizak krvni tlak prilikom ustajanja. Zbog toga možete imati osjećaj omaglice ili nesvjesticu (može

dovesti do padova).

porast razine šećera u krvi.

zamućen vid.

abnormalni snovi i noćne more.

pojačani osjećaj gladi.

osjećaj razdraženosti.

poremećaj u govoru i jeziku.

razmišljanje o samoubojstvu i pogoršanje Vaše depresije.

kratak dah (zaduha).

povraćanje (uglavnom kod starijih osoba).

vrućica.

promjene u količini hormona štitnjače u krvi.

smanjenja broja određenih vrsta krvnih stanica.

povećanja količine jetrenih enzima u krvi.

povećanja količine hormona prolaktina u krvi. Povećane količine hormona prolaktina mogu u

rijetkim slučajevima uzrokovati sljedeće:

oticanje dojki i neočekivano izlučivanje mlijeka iz dojki u muškaraca i žena.

izostanak mjesečnica ili neredovite mjesečnice u žena.

Manje često (mogu se javiti kod 1 na 100 osoba):

napadaji.

alergijske reakcije koje mogu uključivati pojavu uzdignuća (oteklina) na koži, oticanje kože i

oticanje područja oko usta.

neugodan osjećaj u nogama (poznat i kao sindrom nemirnih nogu).

poteškoće s gutanjem.

nekontrolirani pokreti, osobito lica ili jezika.

spolna disfunkcija.

šećerna bolest.

promjena električne aktivnosti srca vidljiva na EKG-u (produljenje QT intervala)

sporiji otkucaji srca

što se može javiti na početku liječenja i može biti povezano s niskim krvnim

tlakom i nesvjesticom.

otežano mokrenje.

nesvjestica (može dovesti do padova).

začepljen nos.

smanjenje količine crvenih krvnih stanica.

smanjenje količine natrija u krvi.

pogoršanje postojeće šećerne bolesti.

Rijetko (mogu se javiti kod 1 na 1000 osoba):

kombinacija visoke tjelesne temperature (vrućica), znojenja, ukočenosti mišića, osjećaja izrazite

omamljenosti ili nesvjestice (poremećaj koji se zove „neuroleptički maligni sindrom“).

žutilo kože i očiju (žutica).

upala jetre (hepatitis).

dugotrajna i bolna erekcija (prijapizam).

oticanje dojki i neočekivano stvaranje mlijeka (galaktoreja).

menstrualni poremećaj.

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

mogu putovati krvnim žilama do pluća uzrokujući bol u prsištu i otežano disanje. Ako primijetite

bilo koji od navedenih simptoma odmah potražite liječničku pomoć.

hodanje, govor, uzimanje hrane ili druge aktivnosti za vrijeme trajanja sna.

sniženje tjelesne temperature (hipotermija).

upala gušterače.

stanje koje se naziva „metaboličkim sindromom“, kod kojega možete imati kombinaciju 3 ili više

od sljedećih faktora: povećanje masnog tkiva oko trbuha, smanjenje razine „dobrog“ (HDL)

kolesterola, povišenje razine jedne vrste masnoća u krvi (triglicerida), visok krvni tlak i povišenje

razine šećera u krvi.

kombinacija vrućice, simptoma nalik gripi, grlobolje ili bilo koja druga infekcija praćena vrlo

niskim brojem bijelih krvnih stanica - to stanje se naziva agranulocitoza.

blokada crijeva.

povećana razina kreatin fosfokinaze u krvi (tvari iz mišića).

Vrlo rijetko (mogu se javiti kod 1 na 10 000 osoba):

težak osip, mjehuri ili crvene mrlje na koži.

teška alergijska reakcija (nazvana anafilaksija), koja može uzrokovati otežano disanje ili izazvati

šok.

brzo oticanje kože, obično oko očiju, usana i u području ždrijela (angioedem).

ozbiljno stanje stvaranja mjehura na koži, ustima, očima i spolnim organima (Stevens-Johnsonov

sindrom).

neodgovarajuće izlučivanje hormona koji kontrolira volumen mokraće.

razgradnja mišićnih vlakana i bol u mišićima (rabdomioliza).

Nepoznato (učestalost se ne može procijeniti na osnovi dostupnih podataka):

osip kože s nepravilnim crvenim mrljama (multiformni eritem).

ozbiljna, iznenadna alergijska reakcija sa simptomima kao što su vrućica, mjehuri na koži i

ljuštenje kože (toksična epidermalna nekroliza).

simptomi ustezanja (prekida primjene lijeka) mogu nastupiti u novorođenčadi čije su majke

uzimale kvetiapin tijekom trudnoće

Lijekovi iz skupine kojoj pripada i Volqer mogu uzrokovati poremećaje srčanoga ritma, koji mogu

biti ozbiljni, a u teškim slučajevima i smrtonosni.

Pojedine nuspojave se mogu uočiti samo ako se učine krvne pretrage. To uključuje promjene razine

određenih masnoća (triglicerida i ukupnog kolesterola) ili šećera u krvi, promjene razine hormona

štitnjače u Vašoj krvi, povišene jetrene enzime, smanjenje broja određenih vrsta krvnih stanica,

smanjenje broja crvenih krvnih stanica, povišenje kreatin fosfokinaze (nalazi se u mišićima) u krvi,

smanjenje količine natrija u krvi i porast razine hormona prolaktina u krvi. U rijetkim slučajevima

porast hormona prolaktina može dovesti do sljedećeg:

oticanje dojki kod muškaraca i žena, te neočekivano stvaranje mlijeka.

izostanak mjesečnice ili neredovite mjesečnice kod žena.

Zbog toga Vaš liječnik može zatražiti da povremeno obavite pretrage krvi.

Nuspojave u djece i adolescenata

Iste nuspojave koje se mogu pojaviti u odraslih mogu se također pojaviti u djece i adolescenata.

Sljedeće nuspojave su uočene češće u djece i adolescenata, ili nisu bile uočene kod odraslih:

H A L M E D

13 - 03 - 2017

O D O B R E N O

Vrlo često (mogu se javiti kod više od 1 na 10 osoba):

porast razine hormona prolaktina u krvi. To u rijetkim slučajevima može dovesti do sljedećeg:

otok dojki kod dječaka i djevojčica, te neočekivano stvaranje mlijeka.

izostanak mjesečnice ili neredovite mjesečnice kod djevojčica.

povećani apetit.

povraćanje.

poremećaj mišićnih pokreta. To uključuje otežano započinjanje mišićnih pokreta, drhtanje, osjećaj

nemira ili bezbolnu ukočenost mišića.

porast krvnog tlaka.

Često (mogu se javiti kod 1 na 10 osoba):

osjećaj slabosti, nesvjestica (može dovesti do padova).

začepljen nos.

osjećaj razdražljivosti.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Volqer

Lijek čuvajte izvan pogleda i dohvata djece.

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

odnosi se na zadnji dan navedenog mjeseca.

HDPE bočice: nakon prvog otvaranja upotrijebiti prije isteka roka valjanosti označenog na bočici iza

oznake „EXP“.

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Volqer sadrži

Djelatna tvar je kvetiapin. Svaka Volqer tableta s produljenim oslobađanjem sadrži 50 mg,

200 mg, 300 mg ili 400 mg kvetiapina (u obliku kvetiapinfumarata).

Drugi sastojci su:

Jezgra tablete:

metakrilatna kiselina/etilakrilat kopolimer (1:1) vrste A, bezvodna laktoza,

magnezijev stearat, kristalična maltoza, talk.

Ovojnica tablete:

metakrilatna kiselina/etilakrilat kopolimer (1:1) vrste A, trietilcitrat.

H A L M E D

13 - 03 - 2017

O D O B R E N O

Kako Volqer izgleda i sadržaj pakiranja

Volqer 50 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, okrugla bikonveksna

tableta, promjera 7,1 mm i debljine 3,2 mm, s utisnutim “50” na jednoj strani.

Volqer 200 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, duguljasta

bikonveksna tableta, dužine 15,2 mm, širine 7,7 mm i debljine 4,8 mm, s utisnutim “200” na

jednoj strani.

Volqer 300 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, duguljasta

bikonveksna tableta, dužine 18,2 mm, širine 8,2 mm i debljine 5,4 mm, s utisnutim “300” na

jednoj strani.

Volqer 400 mg tablete s produljenim oslobađanjem: bijela do skoro bijela, ovalna bikonveksna

tableta, dužine 20,7 mm, širine 10,2 mm i debljine 6,3 mm, s utisnutim “400” na jednoj strani.

Volqer tablete s produljenim oslobađanjem su dostupne u PVC/PCTFE-Al blisterima pakiranim

u kutiju.

Volqer tablete s produljenim oslobađanjem također su dostupne i u bijeloj, neprozirnoj, HDPE

bočici sa polipropilenskim navojnim sigurnosnim zatvaračem za djecu i indukcijski zavarenom

zaštitnom folijom.

Veličine pakiranja za blistere su: 10, 30, 50, 56, 60 i 100 tableta.

Veličina pakiranja za bočice su: 60 i 120 tableta.

Veličina pakiranja od 120 tableta ograničena je za bolničku primjenu.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska

ProizvoĎač

Pharmathen International S.A, Sapes Industrial Park Block 5, Rodopi, 69300, Grčka

Pharmathen S.A, Dervenakion str. 6, Pallini, 15351 Attiki, Grčka

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Njemačka

Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Država članica

Naziv lijeka

Danska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter

Austrija

Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg –

Retardtabletten

Belgija

Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg tabletten met

verlengde afgifte

Bugarska

Kvelux XR 50 mg/150 mg/200 mg/300 mg/400 mg prolonged release

tablet

Njemačka

Quetiapin HEXAL® 50/150/200/300/400 Retardtabletten

Grčka

Quetiapine /Sandoz

Finska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletti

Francuska

Quetiapin Sandoz LP 50 mg/150 mg/200 mg/300 mg/400 mg, comprimé

à libération prolongée

Mađarska

Quetiapine Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg retard tabletta

H A L M E D

13 - 03 - 2017

O D O B R E N O

Irska

Quetex XR 50 mg/200 mg/300 mg/400 mg Prolonged-release tablets

Island

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg forðatöflur

Italija

Quetiapina Sandoz BV

Luksemburg

Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg comprimés à

libération prolongée

Nizozemska

Quetiapine Sandoz SR 50 mg/150 mg/200 mg/300 mg/400 mg, tabletten

met verlengde afgifte

Poljska

Kvelux SR

Portugal

Quetiapina Sandoz

Rumunjska

Netiapin 50 mg/150 mg/200 mg/300 mg/400 mg comprimate cu eliberare

prelungită

Švedska

Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter

Slovenija

Kvelux SR 50 mg/150 mg/200 mg/300 mg/400 mg tablete s podaljšanim

sproščanjem

Slovačka

Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg

Velika Britanija

Psyquet XL 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release

tablets

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u ožujku 2017.

H A L M E D

13 - 03 - 2017

O D O B R E N O

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

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

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

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

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

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under 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

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

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

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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 dimethomorph

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

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

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron 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, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

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

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

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

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

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

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

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

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency