Brufen Effect 400 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Brufen Effect 400 mg filmom obložene tablete
  • Doziranje:
  • 400 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 400 mg ibuprofena
  • Tip recepta:
  • bez recepta, u ljekarni
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Famar S.A., Anthoussa, Attiki, Grčka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Brufen Effect 400 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 10 tableta u blisteru, u kutiji [HR-H-334193871-01]; 20 tableta u blisteru, u kutiji [HR-H-334193871-02] Urbroj: 381-12-01/14-16-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-334193871
  • Datum autorizacije:
  • 05-02-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

UPUTA O LIJEKU: Informacija za korisnika

Brufen Effect 400 mg filmom obložene tablete

ibuprofen

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

podatke.

Uvijek uzmite ovaj lijek točno onako kako je propisano u ovoj uputi ili kako Vam je rekao Vaš

liječnik ili ljekarnik.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se svom ljekarniku.

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

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

Ako ste odrasli bolesnik, obavezno se obratite liječniku ako se ne osjećate bolje ili ako se

osjećate lošije nakon 3 dana u slučaju vrućice i nakon 5 dana u slučaju boli.

Za adolescente se obavezno obratite liječniku ako se ne osjeća bolje ili ako se osjeća lošije

nakon 3 dana.

Što se nalazi u ovoj uputi:

Što su Brufen Effect tablete i za što se koriste?

Što morate znati prije nego počnete uzimati Brufen Effect tablete?

Kako uzimati Brufen Effect tablete?

Moguće nuspojave

Kako čuvati Brufen Effect tablete?

Sadržaj pakiranja i druge informacije

1. Što su Brufen Effect tablete i za što se koriste?

Brufen Effect tablete sadrže djelatnu tvar ibuprofen koji pripada skupini lijekova koji se nazivaju

nesteroidni protuupalni lijekovi ili NSAR lijekovi.

Brufen Effect 400 mg tablete namijenjene su za odrasle i adolescente starije od 12 godina (tjelesne

težine veće od 40 kg).

Koriste se za kratkotrajno simptomatsko liječenje:

blage do umjerene boli poput glavobolje (uključujući migrenu), neuralgije, zubobolje, boli u

leĎima, mišićima i zglobovima i menstrualne boli

snižavanje povišene tjelesne temperature te ublažavanje bolova i tegoba uslijed obične

prehlade i gripe.

Ako ste odrasli bolesnik, obavezno se obratite liječniku ako se simptomi ne povuku ili se pogoršaju,

ili ako je Brufen Effect tablete potrebno primjenjivati dulje od 3 dana u slučaju vrućice i dulje od 5

dana u slučaju boli.

Za adolescente se mora posavjetovati s liječnikom ukoliko se simptomi pogoršaju, ili ako je Brufen

Effect tablete potrebno primjenjivati dulje od 3 dana.

2. Što morate znati prije nego počnete uzimati Brufen Effect tablete?

Nemojte uzimati Brufen Effect tablete

ako ste alergični na ibuprofen ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)

bolovali

reakcija

preosjetljivosti

(astma,

rinitis,

angioedem

urtikarija)

acetilsalicilatnu kiselinu ili druge protuupalne lijekove

H A L M E D

28 - 03 - 2017

O D O B R E N O

ako ste ranije imali krvarenja ili puknuća u probavnom sustavu povezana s primjenom lijekova iz

skupine nesteroidnih protuupalnih lijekova

ako imate čir na želucu/dvanaesniku ili krvarenje u probavnom sustavu ili ste imali ponavljajući

čir na želucu/dvanaesniku ili krvarenje u probavnom sustavu (dvije ili više dokazanih epizoda

čireva ili krvarenja)

ako imate teško srčano zatajenje

ako imate teško zatajenje jetre

ako imate teško zatajenje bubrega

ako imate povećanu sklonost krvarenju ili aktivno krvarenje (uključujući krvarenje u mozgu)

ako ste u posljednjem tromjesečju trudnoće

ako ste mlaĎi od 12 godina (ispod 40 kg tjelesne težine).

ako imate tešku dehidraciju (izraženi gubitak vode iz tijela uzrokovanu povraćanjem, proljevom

ili nedostatnim unosom tekućine).

Ako niste sigurni odnosi li se nešto od navedenog na Vas, upitajte svog liječnika ili ljekarnika.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Brufen Effect tablete:

ako ste trudni ili dojite

ako ste starije životne dobi jer je veća mogućnost pojave nuspojava (osobito krvarenja, čireva ili

puknuća u probavnom sustavu koja mogu imati smrtni ishod) i rizik od oštećenja bubrega.

ako ste imali oboljenja probavnog sustava budući je moguće pogoršanje bolesti. Krvarenja, čirevi

i puknuća u probavnom sustavu mogući su bilo kada tijekom liječenja, mogu imati i smrtni ishod

i mogu se javiti s ili bez upozoravajućih simptoma i bez obzira na prijašnju povijest bolest. U

ovom slučaju, ili ako Vam je nužna terapija acetilsalicilatnom kiselinom u niskoj dozi ili drugim

lijekovima

koji

mogu

povećati

rizik

nuspojava

probavnom

sustavu

(npr.

oralni

kortikosteroidi, antikoagulansi (npr. varfarin), selektivni inhibitori ponovne pohrane serotonina

ili antitrombotici) možda će biti potrebna kombinirana terapija s tzv. zaštitnim lijekovima.

ako tijekom primjene Brufen Effect tableta, posebno na početku liječenja, osjetite bilo kakav

neuobičajeni simptom u trbuhu, obratite se liječniku. Ako tijekom primjene Brufen Effect tableta

doĎe do krvarenja ili čireva u probavnom sustavu, odmah prekinite uzimanje lijeka i obratite se

liječniku.

ako ste imali ili bolujete od kroničnih upalnih bolesti crijeva (ulcerozni kolitis, Crohnova bolest)

ako imate ili ste imali poremećaje dišnog sustava (astma, kronični rinitis, alergijske reakcije).

Brufen Effect tablete mogu povećati rizik od bronhospazma (stezanje dušnica), urtikarije ili

angioedema.

ako se tijekom liječenja Brufen Effect tabletama pojave kožni osip ili druge reakcije na koži,

odmah prestanite uzimati Brufen Effect tablete i obratite se svom liječniku. To mogu biti znakovi

ozbiljnih kožnih reakcija koje se u većini slučajeva javljaju na početku liječenja.

ako imate vodene kozice (lat. varicella)

ranije

imali

imate

peludnu

groznicu,

nazalne

polipe

kroničnu

opstruktivnu

respiratornu

bolest,

postoji

povećan

rizik

alergijske

reakcije

ibuprofen,

čak

anafilaktičkog šoka. Na prvi znak alergijske reakcije prekinite uzimanje lijeka i obratite se

liječniku.

ako imate ili ste imali povišeni krvni tlak ili zatajenje srca, jer je moguć nastanak edema (otoka)

ako imate oštećenu funkciju bubrega jetre ili srca s obzirom da primjena lijekova, kao što su

Brufen Effect tablete, može uzrokovati pogoršanje funkcije bubrega. Taj je rizik povećan i ako

H A L M E D

28 - 03 - 2017

O D O B R E N O

uzimate

razne

lijekove

protiv bolova

ili neke lijekove

snižavanje

visokog

tlaka.

Doza

ibuprofena bi trebala biti najniža moguća, a potrebno je i često kontroliranje funkcije bubrega.

Nakon prekida liječenja, obično slijedi oporavak funkcije bubrega.

ako imate dehidraciju (gubitak vode iz tijela uzrokovan povraćanjem, proljevom ili nedostatnim

unosom tekućine) jer postoji rizik od oštećenja funkcije bubrega, osobito u djece, adolescenata i

starijih osoba

ako ste skloni krvarenju i/ili uzimate lijekove koji utječu na zgrušavanje krvi. Brufen Effect

tablete mogu produljiti vrijeme krvarenja.

ako bolujete od sistemskog eritematoznog lupusa i drugih bolesti vezivnog tkiva. Istodobna

primjena Brufen Effect tableta može povećati rizik od pojave aseptičkog meningitisa.

ako imate nasljednu bolest nepodnošenja nekih šećera

Kao i drugi protuupalni lijekovi iz iste skupine, i Brufen Effect tablete mogu sakriti simptome

infekcije.

Tijekom produljene primjene analgetika može se pojaviti glavobolja koja se ne smije liječit povišenim

dozama lijeka.

Srčani ili moždani udar

Protuupalni lijekovi/lijekovi protiv bolova poput ibuprofena mogu biti povezani s blago povećanim

rizikom od srčanog udara ili moždanog udara, naročito kada se upotrebljavaju u visokim dozama.

Nemojte prekoračiti preporučenu dozu ili trajanje liječenja.

Obratite se svom liječniku ili ljekarniku prije nego uzmete Brufen Effect tablete ako:

imate srčanih problema, uključujući zatajenje srca, anginu (bol u prsištu), ili ako ste imali srčani

udar, ugradnju premosnice, bolest perifernih arterija (slabu cirkulaciju u stopalima zbog uskih ili

začepljenih arterija) ili bilo koju vrstu moždanog udara (uključujući "mini moždani udar" ili

prolazni ishemijski napadaj).

imate visoki krvni tlak, dijabetes, visoki kolesterol, povijest srčane bolesti ili moždanog udara u

obitelji, ili ako ste pušač.

Djeca i adolescenti

Brufen Effect tablete nisu prikladne za djecu mlaĎu od 12 godina (tjelesne težine ispod 40 kg). Za

doziranje u djece postoje prikladniji oblici (tekući). Postoji povećan rizik od oštećenja bubrega u

dehidrirane djece i adolescenata.

Drugi lijekovi i Brufen Effect tablete

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

druge lijekove.

Brufen Effect tablete mogu utjecati na druge lijekove ili na njega mogu utjecati drugi lijekovi.

Primjerice:

drugi protuupalni lijekovi za ublažavanje bolova, uključujući i selektivne inhibitore

ciklooksigenaze 2 (COX-2)

srčani glikozidi (digoksin)

kortikosteroidi (za liječenje upala)

lijekovi koji su antikoagulansi (tj. razrjeĎuju krv/sprječavaju zgrušavanje krvi

primjerice,aspirin/acetilsalicilatna kiselina, varfarin, tiklopidin)

antitrombotici (klopidogrel i tiklopidin)

selektivni inhibitori ponovne pohrane serotonina

litij

H A L M E D

28 - 03 - 2017

O D O B R E N O

lijekovi koji snižavaju visok krvni tlak (ACE-inhibitori poput kaptoprila, beta-blokatori poput

atenolola, antagonisti receptora angiotenzina-II kao što je losartan)

duretici (lijekove za izmokravanje)

metotreksat

ciklosporin i takrolimus (imunosupresivni lijekovi koji se koriste nakon presaĎivanja organa, ili

za liječenje autoimunih bolesti)

zidovudin (antivirusni lijek)

antibiotici koji se nazivaju kinoloni

lijekovi koji inhibiraju enzim CYP2C9, npr. vorikonazol ili flukonazol (lijekovi za liječenje

gljivičnih infekcija)

lijekovi iz skupine sulfoniluree (za liječenje šećerne bolesti)

kolestiramin (za liječenje visokih razina kolesterola)

antibiotici koji se nazivaju am inoglikozidi

biljni preparati koji sadržavaju Gingko bilobu

mifepriston

alkohol

fenitoin (za liječenje epilepsije)

probenecid i sulfinpirazon

Liječenje Brufen Effect tabletama moglo bi takoĎer utjecati na neke druge lijekove ili bi oni mogli

utjecati na Brufen Effect tablete. Uvijek provjerite s Vašim liječnikom ili ljekarnikom prije upotrebe

lijeka Brufen Effect tablete zajedno s drugim lijekovima.

Brufen Effect tablete s hranom, pićem i alkoholom

Brufen Effect tablete se mogu uzimati tijekom ili nakon obroka.

Tijekom istodobne primjene alkohola, mogu se povećati nuspojave NSAR lijekova, posebice one

povezane s probavnim ili središnjim živčanim sustavom. TakoĎer, u većoj mjeri u kombinaciji s

alkoholom ibuprofen može utjecati na Vaše vrijeme reagiranja tj. budnost.

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.

Tijekom prvih šest mjeseci trudnoće ibuprofen se ne smije primijeniti osim u neophodnim situacijama

po savjetu liječnika. Ibuprofen se ne smije koristiti u posljednjem tromjesečju trudnoće.

Ne preporuča se primjena ibuprofena tijekom dojenja.

Uporaba ibuprofena može smanjiti plodnost žena i ne preporuča se kod žena koje pokušavaju začeti.

Upravljanje vozilima i strojevima

Ibuprofen može utjecati na Vaše vrijeme reagiranja. Može izazvati omaglicu, umor, pospanost i

smetnje vida. Potreban je oprez kod upravljanja vozilima, strojevima ili obavljanja poslova koji

zahtijevaju budnost. Ovo vrijedi u većoj mjeri kada se ibuprofen koristi u kombinaciji s alkoholom.

Brufen Effect tablete sadrže laktozu.

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

3. Kako uzimati Brufen Effect tablete?

Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik

ili ljekarnik. Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.

H A L M E D

28 - 03 - 2017

O D O B R E N O

Ovaj je lijek namijenjen samo za kratkotrajnu primjenu. Morate uzimati najnižu moguću dozu kroz

najkraće moguće vrijeme potrebno za uklanjanje simptoma.

Lijek je primjeren za odrasle i adolescente starije od 12 godina (tjelesne težine veće od 40 kg).

Doziranje

Odrasli i adolescenti stariji od 12 godina (tjelesne težine ≥40 kg): 1 tableta (400 mg) u pojedinačnoj

dozi, do tri puta na dan s razmakom izmeĎu doza od 4 do 6 sati.

Maksimalna pojedinačna doza za odrasle i adolescente ne smije biti veća od 400 mg ibuprofena. Više

od 400 mg odjednom ne daje bolji analgetski učinak.

Ne smije proći manje od 4 sata izmeĎu pojedinačnih doza.

Za odrasle i adolescente, ukupna dnevna doza od 1200 mg ne smije se premašiti u bilo kojem 24-

satnom periodu.

Ako ste odrasli bolesnik, obavezno se obratite liječniku ako se simptomi ne povuku ili se pogoršaju,

ili ako je Brufen Effect tablete potrebno primjenjivati dulje od 3 dana u slučaju vrućice i dulje od 5

dana u slučaju boli.

Za adolescente se mora posavjetovati s liječnikom ukoliko se simptomi pogoršaju, ili ako je Brufen

Effect tablete potrebno primjenjivati dulje od 3 dana.

Djeca: Brufen Effect u obliku tableta od 400 mg nije prikladan za djecu mlaĎu od 12 godina (tjelesne

težine manje od 40 kg).

Za doziranje u djece postoje prikladniji oblici (tekući).

Stariji: Nije potrebna posebna prilagodba doze, no potreban je oprez zbog mogućih nuspojava.

Potrebno je potražiti savjet liječnika.

Oštećenje funkcije bubrega i jetre: Nije potrebno smanjenje doze ako imate blago do umjereno

oštećenje bubrežne ili jetrene funkcije. U slučaju teškog zatajenja bubrega ili jetre, ne smijete uzimati

ovaj lijek. Potrebno je potražiti savjet liječnika.

Način primjene

Za primjenu kroz usta.

Brufen Effect tablete treba uzeti s dosta tekućine tijekom ili nakon obroka. Tablete se trebaju

progutati cijele te se ne smiju žvakati, lomiti, drobiti ili sisati kako bi se izbjegao neugodan osjećaj u

ustima i iritacija grla.

Kako bi se postigao brži početak djelovanja, doza se može uzeti na prazan želudac. Ako imate

osjetljiviji želudac preporuča se uzimanje Brufen Effect tableta s hranom.

Ako uzmete više Brufen Effect tableta nego što ste trebali

netko

drugi

nehotice

uzeli

znatno

veće

doze

lijeka

nego

što

preporučeno

(predoziranje), odmah obavijestite svojeg liječnika ili se obratite najbližoj bolničkoj hitnoj službi.

Ukoliko je došlo do predoziranja značajnim količinama Brufen Effect tableta, simptomi se obično

javljaju unutar 4 do 6 sati, a najčešći su mučnina, povraćanje, bolovi u trbuhu, otupljenost (letargija) i

omamljenost.

Ako ste zaboravili uzeti Brufen Effect tablete

Ako zaboravite uzeti lijek, u slučaju da je i dalje prisutna vrućica ili bol uzmite sljedeću dozu lijeka.

Vremenski razmak izmeĎu doza ne smije biti manji od 4 sata. Nemojte uzeti dvostruku dozu kako

biste nadoknadili zaboravljenu dozu.

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28 - 03 - 2017

O D O B R E N O

U slučaju bilo kakvih nejasnoća ili 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.

U slučaju pojave sljedećih nuspojava, odmah prestanite s uzimanjem lijeka i obavijestite Vašeg

liječnika:

- kožni osip, ozljede sluznica ili drugi znakovi preosjetljivosti kože

- oticanje lica, jezika, grla, poteškoće s disanjem (angioedem, anafilaktički šok)

- pojava ili pogoršanje znakova infekcije (npr. nekroza mekih tkiva i veziva), posebno uz vodene

kozice

- jaka glavobolja, povišena tjelesna temperatura, ukočenost vrata i preosjetljivost na svjetlost

- krvava stolica

- izrazito tamno obojena stolica (kao katran)

- povraćanje svježe krvi ili tamnih komadića koji izgledaju kao zrna kave.

Sljedeće nuspojave se mogu pojaviti pri primjeni ovog lijeka:

Česte (mogu se pojaviti izmeĎu 1 i 10 na 100 bolesnika)

omaglica, glavobolja

loša probava, proljev, mučnina, povraćanje, bolovi u trbuhu, nadutost, zatvor, krv u stolici,

povraćanje krvi, krvarenje u probavnom sustavu

osip

umor.

Manje česte (mogu se pojaviti izmeĎu 1 i 10 na 1000 bolesnika)

curenje iz nosa (rinits)

preosjetljivost

nesanica, tjeskoba

neobični osjeti na koži kao što su utrnulost, trnci, bockanje, žarenje ili mravinjanje (parestezija),

jaka pospanost

smetnje vida

smetnje sluha, zujanje u ušima, vrtoglavica (vertigo)

astma, stezanje dušnica (bronzospazam), dispneja

gastritis, čir na dvanaesniku/želucu, vrijed (ulceracije) u ustima, puknuća u probavnom sustavu

upala jetre (hepatitis), žutica, poremećaj funkcije jetre

urtikarija, svrbež, purpura, angioedem, fotosenzitivnost.

Rijetke (mogu se pojaviti u manje od 1 na 1000 bolesnika)

aseptički meningitis

poremećaji krvi i limfnog sustava (leukopenija, trombocitopenija, aplastična anemija,

neutropenija, agranulocitoza i hemolitička anemija)

anafilaktična reakcija

depresija, stanje zbunjenosti, halucinacije

optički neuritis

toksična optička neuropatija

ozljeda jetre

edem.

Vrlo rijetke (mogu se pojaviti u manje od 1 na 10000 bolesnika)

zatajenje srca, infarkt miokarda

povišeni krvni tlak

H A L M E D

28 - 03 - 2017

O D O B R E N O

upala gušterače

zatajenje jetre

teške

reakcije

preosjetljivosti

(simptomi

mogu

biti:

oticanje

lica,

jezika

grla,

dispneja,

tahikardija, hipotenzija do razine životno ugrožavajućeg šoka)

teške kožne reakcije (npr. multiformni eritem, bulozne reakcije uključujući Stevens-Johnsonov

sindrom i toksičnu epidermalnu nekrolizu)

različiti oblici toksičnosti za bubrege, uključujući tubulointersticijski nefritis, nefrotski sindrom i

zatajenje bubrega.

Nepoznate (učestalost se ne može procijeniti na temelju dostupnih podataka):

kolitis i Crohnova bolest.

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 Brufen Effect tablete?

Lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25ºC.

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

Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

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 Brufen Effect tablete sadrže?

Djelatna tvar je ibuprofen.

Jedna Brufen Effect 400 mg filmom obložena tableta sadrži 400 mg ibuprofena.

Drugi sastojci (pomoćne tvari) su: mikrokristalična celuloza, umrežena, karmelozanatrij, laktoza

hidrat, silicijev dioksid koloidni bezvodni, natrijev laurilsulfat, magnezijev stearat, hipromeloza, talk i

titanijev dioksid (E171).

Kako Brufen Effect tablete izgledaju i sadržaj pakiranja?

Bijele, ovalne tablete.

Kutija s 10 filmom obloženih tableta u blisteru (1x10).

Kutija s 20 filmom obloženih tableta u blisteru (2x10).

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

Mylan Hrvatska d.o.o.

Koranska 2

10000 Zagreb

H A L M E D

28 - 03 - 2017

O D O B R E N O

Proizvođač:

Famar S.A.

7 Anthoussa Av.

153 44 Anthoussa Attiki

Grčka

Način i mjesto izdavanja lijeka

Lijek se izdaje bez recepta, u ljekarni.

Ova uputa je zadnji put revidirana u studenom 2016.

H A L M E D

28 - 03 - 2017

O D O B R E N O

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

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

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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