Pregabalin Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Antiepileptici
  • Područje terapije:
  • Epilepsija
  • Terapijske indikacije:
  • Epilepsija.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/004024
  • Datum autorizacije:
  • 28-08-2015
  • EMEA koda:
  • EMEA/H/C/004024
  • Zadnje ažuriranje:
  • 03-03-2018

Izvješće o ocjeni javnog

EMA/344103/2017

EMEA/H/C/004024

EPAR, sažetak za javnost

Pregabalin Accord

pregabalin

Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Pregabalin Accord. Objašnjava

kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu

primjenu. Svrha sažetka nije davati praktične savjete o primjeni lijeka Pregabalin Accord.

Praktične informacije o primjeni lijeka Pregabalin Accord bolesnici trebaju pročitati u uputi o lijeku,

odnosno trebaju se obratiti svojem liječniku ili ljekarniku.

Što je Pregabalin Accord i za što se koristi?

Pregabalin Accord je lijek koji se koristi za liječenje odraslih osoba sa sljedećim bolestima:

neuropatskom boli (boli uslijed oštećenja živca), uključujući perifernu neuropatsku bol, poput boli

koju iskuse bolesnici oboljeli od dijabetesa ili herpes zosterom (pasac), i središnjom neuropatskom

boli, poput boli koju osjete bolesnici koji imaju ozljedu kralježnične moždine;

epilepsijom, kada se koristi kao dodatna terapija uz druge terapije za liječenje epilepsije u

bolesnika koji imaju parcijalne napadaje (epileptične napadaje koji izbijaju u jednom specifičnom

djelu mozga);

generaliziranim anksioznim poremećajem (kroničnom anksioznosti ili nervozom vezanom uz

svakodnevnicu).

Pregabalin Accord sadrži djelatnu tvar pregabalin.

Pregabalin Accord je „generički lijek”. To znači da Pregabalin Accord sadrži istu djelatnu tvar i djeluje

na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Lyrica. Više

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

Pregabalin Accord

EMA/344103/2017

Stranica 2/3

Kako se Pregabalin Accord koristi?

Lijek Pregabalin Accord dostupan je u kapsulama (25, 50, 75, 100, 150, 200, 225 i 300 mg), a izdaje

se samo na liječnički recept. Preporučena početna doza je 150 mg na dan, podijeljeno u dvije ili tri

doze. Nakon tjedan dana doza se može povećati na 300 mg na dan. Doze se mogu povećavati sve dok

se ne dosegne najdjelotvornija doza. Maksimalna doza je 600 mg na dan. Da bi se terapija lijekom

Pregabalin Accord prekinula dozu treba postupno smanjivati, tijekom najmanje jednog tjedna. Bolesnici

koji imaju probleme s bubrezima možda će trebati uzimati manju dozu lijeka.

Kako djeluje Pregabalin Accord?

Djelatna tvar lijeka Pregabalin Accord, pregabalin, slična je po strukturi neurotransmiteru tijela, gama-

aminobutiričnoj kiselini (GABA), no ima vrlo različito biološko djelovanje. Neurotransmiteri su

kemikalije koje omogućuju međusobnu komunikaciju živčanih stanica. Nije u potpunosti poznat način

na koji pregabalin djeluje, no smatra se da utječe na način na koji kalcij ulazi u živčane stanice. Time

se smanjuje aktivnost pojedinih živčanih stanica u mozgu i kralježničnoj moždini, čime se smanjuje

otpuštanje drugih neurotransmitera koji su uključeni u epilepsiju i anksioznost.

Kako je Pregabalin Accord ispitivan?

Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni

lijek Lyrica te ih ne treba ponavljati za lijek Pregabalin Accord.

Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Pregabalin Accord. Tvrtka je provela i

ispitivanja koja su pokazala da je lijek „bioekvivalentan” referentnom lijeku. Dva su lijeka

bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari, pa se stoga očekuje da imaju

jednak učinak.

Koje su koristi i rizici lijeka Pregabalin Accord?

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

njegove koristi i rizici isti kao i oni referentnog lijeka.

Zašto je lijek Pregabalin Accord odobren?

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

EU-a, potvrđeno da Pregabalin Accord posjeduje usporedivu razinu kvalitete i da je bioekvivalentan

lijeku Lyrica. Stoga je stav CHMP-a da korist nadmašuje identificirani rizik, kao i za lijek Lyrica. Odbor

je preporučio davanje odobrenja za stavljanje lijeka Pregabalin Accord u promet u EU-u.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Pregabalin Accord?

Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i

učinkovite primjene lijeka Pregabalin Accord nalaze se u sažetku opisa svojstava lijeka i u uputi o

lijeku.

Ostale informacije o lijeku Pregabalin Accord

Europska komisija izdala je odobrenje za stavljanje lijeka Pregabalin Accord u promet koje vrijedi na

prostoru Europske unije od 28. kolovoza 2015.

Pregabalin Accord

EMA/344103/2017

Stranica 3/3

Cjeloviti EPAR za lijek Pregabalin Accord nalazi se na internetskim stranicama

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

. Više

informacija o liječenju lijekom Pregabalin Accord pročitajte u uputi o lijeku (također dio EPAR-a),

odnosno obratite se svojem liječniku ili ljekarniku.

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

Ovaj je sažetak posljednji put ažuriran u 06. 2017.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za korisnika

Pregabalin Accord 25 mg tvrde kapsule

Pregabalin Accord 50 mg tvrde kapsule

Pregabalin Accord 75 mg tvrde kapsule

Pregabalin Accord 100 mg tvrde kapsule

Pregabalin Accord 150 mg tvrde kapsule

Pregabalin Accord 200 mg tvrde kapsule

Pregabalin Accord 225 mg tvrde kapsule

Pregabalin Accord 300 mg tvrde kapsule

pregabalin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.

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

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Pregabalin Accord i za što se koristi

Što morate znati prije nego počnete uzimati Pregabalin Accord

Kako uzimati Pregabalin Accord

Moguće nuspojave

Kako čuvati Pregabalin Accord

Sadržaj pakiranja i druge informacije

1.

Što je Pregabalin Accord i za što se koristi

Pregabalin Accord pripada skupini lijekova koji se koriste za liječenje epilepsije, neuropatske boli i

generaliziranog anksioznog poremećaja (GAP) u odraslih osoba.

Periferna i centralna neuropatska bol

Ovaj se lijek se koristi za liječenje dugotrajne boli uzrokovane oštećenjem živaca. Perifernu

neuropatsku bol mogu uzrokovati različite bolesti, primjerice šećerna bolest ili herpes zoster. Osjet

bola može se opisati kao vrućina, žarenje, pulsirajuća bol, sijevajuća bol, probadanje, oštra bol, grčevi,

stalna tupa bol, trnci, utrnulost, bockanje. Periferna i centralna neuropatska bol mogu biti povezane i s

promjenama raspoloženja, poremećajem spavanja te umorom (iscrpljenošću), a mogu utjecati na

tjelesno i socijalno funkcioniranje i ukupnu kvalitetu života.

Epilepsija

Ovaj se lijek koristi za liječenje nekih oblika epilepsije (parcijalnih napadaja sa ili bez sekundarne

generalizacije) u odraslih osoba. Liječnik će Vam propisati Pregabalin Accord za liječenje epilepsije

kada lijekovi koje ste do sada uzimali bolest ne drže pod kontrolom. Pregabalin Accord morate

uzimati kao dodatak postojećim lijekovima. Pregabalin Accord nije namijenjen za samostalnu

primjenu, nego se uvijek mora uzimati u kombinaciji s drugim antiepileptičkim lijekovima.

Generalizirani anksiozni poremećaj

Ovaj se lijek koristi za liječenje generaliziranog anksioznog poremećaja (GAP). Simptomi GAP-a su

dugotrajna prekomjerna tjeskoba i zabrinutost koje je teško kontrolirati. GAP može uzrokovati i nemir

ili osjećaj napetosti ili bezizlaznosti, brzo iscrpljivanje (umaranje), poteškoće s koncentracijom ili

prisjećanjem, razdražljivost, napetost mišića ili poremećaj spavanja. To se razlikuje od stresa i

napetosti u svakodnevnom životu.

2.

Što morate znati prije nego počnete uzimati Pregabalin Accord

Nemojte uzimati Pregabalin Accord:

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

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Pregabalin Accord.

Neki bolesnici koji su uzimali ovaj lijek prijavili su simptome koji ukazuju na alergijsku

reakciju. Ti simptomi uključuju oticanje lica, usana, jezika i grla, kao i prošireni osip kože. Ako

se pojavi neka od tih reakcija, morate se odmah javiti svom liječniku.

Liječenje ovim lijekom povezuje se s pojavom omaglice i pospanosti, što može povećati broj

slučajnih ozljeda (padova) u starijih bolesnika. Stoga, morate biti oprezni dok se ne naviknete

na sve moguće učinke lijeka.

Ovaj lijek može uzrokovati zamagljen vid, gubitak vida ili druge promjene vida, od kojih su

mnoge privremene. Morate odmah obavijestiti svog liječnika ako primijetite bilo kakve

promjene vida.

Nekim bolesnicima sa šećernom bolešću koji dobiju na težini dok uzimaju pregabalin će možda

trebati promijeniti terapiju lijekovima protiv šećerne bolesti.

Neke nuspojave, poput pospanosti, mogu se javljati češće jer bolesnici s ozljedom leđne

moždine možda uzimaju druge lijekove za liječenje, primjerice, boli ili grčeva, koji imaju slične

nuspojave kao pregabalin. Ove nuspojave mogu biti teže kada se ti lijekovi uzimaju zajedno.

U nekih je bolesnika pri uzimanju ovog lijeka prijavljeno zatajenje srca; radilo se uglavnom o

starijim bolesnicima s postojećim bolestima srca i krvožilja.

Prije uzimanja ovog lijeka

morate obavijestiti svog liječnika ako ste bolovali od neke bolesti srca.

U nekih je bolesnika pri uzimanju ovog lijeka prijavljeno zatajenje bubrega. Ako tijekom

uzimanja ovog lijeka primijetite da manje mokrite, morate o tome obavijestiti svog liječnika jer

se prekidom primjene lijeka to može poboljšati.

Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je Pregabalin Accord

razmišljali su o samoozljeđivanju ili samoubojstvu. Ako Vas u bilo kojem trenutku obuzmu

takve misli, odmah se javite svom liječniku.

Kada se Pregabalin Accord uzima s drugim lijekovima koji mogu uzrokovati zatvor (kao što su

neke vrste lijekova protiv bolova), moguće je da se pojave probavne tegobe (primjerice zatvor,

blokada ili paraliza crijeva). Obavijestite svog liječnika ako imate zatvor, pogotovo ako ste

skloni toj tegobi.

Prije uzimanja ovog lijeka morate obavijestiti svog liječnika a

ko ste imali problema s

alkoholizmo

m, zlouporabom lijekova ili ovisnošću. Ne uzimajte više lijeka nego što Vam je

propisano.

Za vrijeme uzimanja ili nedugo nakon prestanka uzimanja ovog lijeka prijavljene su konvulzije.

Ako doživite konvulzije, odmah se javite liječniku.

Prijavljeno je smanjenje moždane funkcije (encefalopatija) u nekih bolesnika koji su uzimali

ovaj lijek, a bolovali su i od drugih bolesti. Obavijestite svog liječnika ako ste bolovali od neke

ozbiljne bolesti, uključujući bolesti jetre ili bubrega.

Djeca i adolescenti

Sigurnost i djelotvornost u djece i adolescenata (mlađih od 18 godina) nisu ustanovljene te stoga

pregabalin ne treba koristiti u ovoj dobnoj skupini.

Drugi lijekovi i Pregabalin Accord

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

druge lijekove.

Pregabalin Accord i neki drugi lijekovi mogu djelovati jedni na druge (interakcija). Kada se uzima s

nekim drugim lijekovima, Pregabalin Accord može pojačati nuspojave tih lijekova, uključujući

zatajenje disanja i komu. Omaglica, pospanost i smanjenje koncentracije mogu se pojačati ako se

Pregabalin Accord uzima zajedno s lijekovima koji sadrže:

Oksikodon - (koristi se protiv bolova)

Lorazepam - (koristi se za liječenje tjeskobe)

Alkohol

Ovaj se lijek može uzimati s oralnim kontraceptivima.

Pregabalin Accord s hranom, pićem i alkoholom

Ovaj se lijek može uzimati s hranom ili bez nje.

Preporučuje se da ne pijete alkohol dok uzimate ovaj lijek.

Trudnoća i dojenje

Ovaj se lijek ne smije uzimati tijekom trudnoće ili dojenja, osim ako Vam liječnik nije rekao

drugačije. Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju. Ako ste trudni ili dojite,

mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za

savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Ovaj lijek može izazvati omaglicu, pospanost i smanjenu koncentraciju. Ne biste trebali voziti,

rukovati složenim strojevima ni poduzimati druge potencijalno opasne aktivnosti dok ne utvrdite

utječe li ovaj lijek na Vašu sposobnost da to činite.

3.

Kako uzimati Pregabalin Accord

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

ili ljekarnikom ako niste sigurni.

Vaš će liječnik odrediti koja doza je prikladna za Vas.

Ovaj je lijek namijenjen samo za primjenu kroz usta.

Periferna i centralna neuropatska bol, epilepsija ili generalizirani anksiozni poremećaj:

Uzmite onoliko kapsula koliko Vam je odredio liječnik.

Doza, koja je prilagođena Vama i Vašoj bolesti, u pravilu će iznositi između 150 mg i 600 mg

svakoga dana.

Liječnik će Vam reći da uzmete ovaj lijek dva puta ili tri puta na dan. Ako ovaj lijek uzimate

dva puta na dan, uzmite jednu dozu ujutro te jednu navečer, svakoga dana otprilike u isto

vrijeme. Ako ovaj lijek uzimate tri puta na dan, uzmite jednu dozu ujutro, jednu dozu

poslijepodne te jednu navečer, svakoga dana otprilike u isto vrijeme.

Ako Vam se čini da je djelovanje ovog lijeka prejako ili preslabo, porazgovarajte sa svojim liječnikom

ili ljekarnikom.

Ako ste bolesnik u starijoj dobi (iznad 65 godina), ovaj lijek trebate uzimati normalno, osim ako

imate problema s bubrezima.

Ako imate problema s bubrezima, liječnik Vam može propisati drugačiji raspored doziranja i/ili dozu.

Kapsule progutajte cijele s vodom.

Nastavite uzimati ovaj lijek dok Vam liječnik ne kaže da prestanete.

Ako uzmete više lijeka Pregabalin Accord nego što ste trebali

Odmah nazovite svog liječnika ili otiđite u hitnu službu najbliže bolnice. Uzmite sa sobom kutiju ili

bocu ovog lijeka. Kao posljedica uzimanja previše ovog lijeka možete biti pospani, zbunjeni,

uznemireni ili nemirni. Prijavljeni su također i napadaji.

Ako ste zaboravili uzeti lijek Pregabalin Accord

Važno je da ovaj lijek uzimate redovito, svakoga dana u isto vrijeme. Ako ste zaboravili uzeti dozu,

uzmite je čim se sjetite, osim ako nije vrijeme za sljedeću dozu. U tom slučaju samo nastavite sa

sljedećom dozom kao i obično. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu

dozu.

Ako prestanete uzimati lijek Pregabalin Accord

Nemojte prestati uzimati ovaj lijek ako Vam to ne kaže liječnik. Ako se liječenje prekida, to treba

učiniti postupno tijekom najmanje tjedan dana.

Morate znati da nakon prekida dugotrajnog i kratkotrajnog liječenja lijekom Pregabalin Accord mogu

nastupiti određene nuspojave. One uključuju poteškoće sa spavanjem, glavobolju, mučninu, osjećaj

tjeskobe, proljev, simptome nalik gripi, konvulzije, nervozu, depresiju, bol, znojenje i omaglicu. Ti

simptomi mogu biti češći ili ozbiljniji ako ste ovaj lijek uzimali dulje vrijeme.

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

4.

Moguće nuspojave

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

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

Omaglica, omamljenost, glavobolja.

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

pojačan tek

ushićenje, smetenost, dezorijentiranost, smanjenje seksualne želje, razdražljivost

poremećaj pažnje, nespretnost, poremećaj pamćenja, gubitak pamćenja, nevoljno drhtanje

(tremor), poteškoće pri govoru, osjećaj trnaca, utrnulost, sedacija, letargija, nesanica, umor,

neuobičajeno osjećanje

zamagljen vid, dvoslike

vrtoglavica, poteškoće s ravnotežom, pad

suha usta, zatvor, povraćanje, vjetrovi, proljev, mučnina, otečen trbuh

poteškoće s erekcijom

oticanje tijela, uključujući udove

osjećaj pijanosti, neuobičajen način hodanja

porast tjelesne težine

grčevi u mišićima, bol u zglobovima, bol u leđima, bol u udovima

grlobolja.

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

gubitak teka, gubitak tjelesne težine, niska razina šećera u krvi, visoka razina šećera u krvi

promijenjena slika o sebi, nemir, depresija, uznemirenost, promjene raspoloženja, poteškoće u

pronalaženju riječi, halucinacije, neuobičajeni snovi, napadaj panike, apatija, agresija, povišeno

raspoloženje, slabljenje mentalnih sposobnosti, poteškoće pri razmišljanju, povećanje seksualne

želje, tegobe sa spolnom funkcijom uključujući nemogućnost postizanja orgazma, odgođena

ejakulacija

promjene vida, neuobičajeni pokreti očiju, promjene vida uključujući gubitak perifernog vida

(kao da gledate kroz cijev), bljeskovi svjetla, trzajni pokreti, smanjeni refleksi, pojačana

aktivnost, omaglica pri ustajanju, osjetljivost kože, gubitak osjeta okusa, osjećaj pečenja,

nevoljni pokreti pri kretanju, smanjena svijest, gubitak svijesti, nesvjestica, pojačana osjetljivost

na buku, loše osjećanje

suhe oči, oticanje očiju, bol u oku, slabost očiju, suzne oči, nadraženost očiju

poremećaji srčanog ritma, ubrzani puls, nizak krvni tlak, visok krvni tlak, promjene otkucaja

srca, zatajenje srca

navale crvenila, navale vrućine

otežano disanje, suhoća nosne sluznice, začepljen nos

pojačano stvaranje sline, žgaravica, utrnulost oko usta

znojenje, osip, zimica, vrućica

trzanje mišića, oticanje zglobova, ukočenost mišića, bol uključujući bol u mišićima, bol u vratu

bol u dojkama

otežano ili bolno mokrenje, inkontinencija

slabost, žeđ, stezanje u prsištu

promjene u rezultatima pretraga krvi i jetre (povišene vrijednosti kreatin fosfokinaze u krvi,

povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze,

smanjen broj krvnih pločica, smanjen broj neutrofila, povećanje kreatinina u krvi, snižene

vrijednosti kalija u krvi)

preosjetljivost, oticanje lica, svrbež, koprivnjača, curenje iz nosa, krvarenje iz nosa, kašalj

hrkanje

bolne mjesečnice

hladnoća šaka i stopala.

Rijetke (m

ogu se javiti u do 1 na 1000 osoba):

neuobičajen osjet mirisa, nemogućnost fokusiranja slike, promijenjena percepcija dubine,

osjećaj svjetline pri gledanju, gubitak vida

proširene zjenice, ukrižene oči

hladan znoj, stezanje u grlu, oticanje jezika

upala gušterače

otežano gutanje

usporeni ili umanjeni pokreti tijela

poteškoće pri pravilnom pisanju

nakupljanje tekućine u trbuhu

tekućina u plućima

konvulzije

promjene na elektrokardiogramu (EKG-u) koje odgovaraju poremećajima srčanog ritma

oštećenje mišića

iscjedak iz dojke, neuobičajen rast dojki, rast dojki u muškaraca

prekid menstrualnog ciklusa

zatajenje bubrega, smanjen volumen mokraće, zadržavanje mokraće

smanjen broj bijelih krvnih stanica

neprilagođeno ponašanje

alergijske reakcije (koje mogu obuhvaćati otežano disanje, upalu očiju (keratitis) i ozbiljne

kožne reakcije koje obilježavaju osip, mjehurići, ljuštenje kože i bol)

žutica (žutilo kože i bjeloočnica)

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

zatajenje jetre

hepatitis (upala jetre)

Primijetite li oticanje lica ili jezika, ili se na koži pojavi crvenilo, mjehurići ili ljuštenje, morate

odmah potražiti savjet liječnika.

Neke nuspojave, poput pospanosti, mogu se javljati češće jer bolesnici s ozljedom leđne moždine

možda uzimaju druge lijekove za liječenje, primjerice, boli ili grčeva, koji imaju slične nuspojave kao

pregabalin. Ove nuspojave mogu biti ozbiljnije kada se ti lijekovi uzimaju zajedno.

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi.

Prijavljivanje nuspojava

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

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

nacionalnog sustava za prijavu nuspojava navedenog u

Dodatku V . Prijavljivanjem nuspojava možete

pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Pregabalin Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili boci. Rok

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

Nakon prvog otvaranja, HDPE bocu treba iskoristiti u roku od 30 dana (za bocu s 30 kapsula) i 100

dana (za bocu s 200 kapsula).

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

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

6.

Sadržaj pakiranja i druge informacije

Što Pregabalin Accord sadrži

Djelatna tvar je pregabalin. Jedna tvrda kapsula sadrži 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,

200 mg, 225 mg, 300 mg pregabalina.

Drugi sastojci su: prethodno geliran škrob, talk (E553b), želatina, titanijev dioksid (E171), natrijev

laurilsulfat, crna tinta, (koja sadrži šelak, propilenglikol, crni željezov oksid (E172) i kalijev

hidroksid).

Kapsule od 75 mg, 100 mg, 200 mg, 225 mg i 300 mg također sadrže crveni željezov oksid (E172).

Kako Pregabalin Accord izgleda i sadržaj pakiranja

25 mg kapsule

Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim

tijelom, veličine „4“ s otisnutom oznakom „PG“ na kapici i „25“ na tijelu.

Jedna je kapsula duga otprilike 14,4 mm.

50 mg kapsule

Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim

tijelom, veličine „3“ s otisnutom oznakom „PG“ na kapici i „50“ na tijelu.

Jedna je kapsula duga otprilike 15,8 mm.

75 mg kapsule

Tvrde želatinske kapsule s crvenom neprozirnom kapicom i bijelim

neprozirnim tijelom, veličine „4“ s otisnutom oznakom „PG“ na kapici i „75“

na tijelu. Jedna je kapsula duga otprilike 14,4 mm.

100 mg kapsule

Tvrde želatinske kapsule s crvenom neprozirnom kapicom i crvenim

neprozirnim tijelom, veličine „3“ s otisnutom oznakom „PG“ na kapici i „100“

na tijelu. Jedna je kapsula duga otprilike 15,8 mm.

150 mg kapsule

Tvrde želatinske kapsule s bijelom neprozirnom kapicom i bijelim neprozirnim

tijelom, veličine „2“ s otisnutom oznakom „PG“ na kapici i „150“ na tijelu.

Jedna je kapsula duga otprilike 17,8 mm.

200 mg kapsule

Tvrde želatinske kapsule s narančastom neprozirnom kapicom i narančastim

neprozirnim tijelom, veličine „1“ s otisnutom oznakom „PG“ na kapici i „200“

na tijelu. Jedna je kapsula duga otprilike 19,3 mm.

225 mg kapsule

Tvrde želatinske kapsule s narančastom neprozirnom kapicom i bijelim

neprozirnim tijelom, veličine „1“ s otisnutom oznakom „PG“ na kapici i „225“

na tijelu. Jedna je kapsula duga otprilike 19,3 mm.

300 mg kapsule

Tvrde želatinske kapsule s crvenom neprozirnom kapicom i bijelim

neprozirnim tijelom, veličine „0“ s otisnutom oznakom „PG“ na kapici i „300“

na tijelu. Jedna je kapsula duga otprilike 21,4 mm.

Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su u

PVC/aluminijskim blisterima u veličinama pakiranja od 14, 21, 56, 60, 84, 90, 100 ili 112 tvrdih

kapsula. Osim Pregabalin Accord tvrde kapsule od 75mg su također dostupne su u PVC / aluminijskim

blisterima u veličinama pakiranja od 70 tvrdih kapsula.

Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su kao 100 x 1 tvrda

kapsula u PVC/aluminijskim perforiranim blisterima djeljivim na jedinične doze.

Pregabalin Accord tvrde kapsule od 25/50/75/100/150/200/225/300 mg dostupne su također u HDPE

boci koja sadrži 30 ili 200 tvrdih kapsula.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow,

Middlesex, HA1 4HF

Ujedinjeno Kraljevstvo

Proizvođač

Accord Healthcare Limited

Sage house, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF,

Ujedinjeno Kraljevstvo

Wessling Hungary Kft

Fòti ùt 56., Budimpešta 1047,

Mađarska

Ova uputa je zadnji puta revidirana u

Drugi izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

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

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

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

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

1-8-2018

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Pfizer Europe MA EEIG)

Lyrica (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5223 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/546/T/95

Europe -DG Health and Food Safety

1-8-2018

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Pfizer Limited)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5234 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/T/24

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