Amaryl 3 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Amaryl 3 mg tablete
  • Doziranje:
  • 3 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 3 mg glimepirida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • sanofi-aventis S.p.A., Scoppito (L'Aquila), Italija; Sanofi Winthrop Industrie, Tours, Francuska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Amaryl 3 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Urbroj: 381-12-01/70-15-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-851734879
  • Datum autorizacije:
  • 29-01-2015
  • Zadnje ažuriranje:
  • 04-06-2018

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

Uputa o lijeku: Informacija za korisnika

AMARYL 2 mg tablete

AMARYL 3 mg tablete

glimepirid

Pročitajte pažljivo cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se svom 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 Amaryl i za što se koristi

Što morate znati prije nego počnete uzimati Amaryl

Kako uzimati Amaryl

Moguće nuspojave

Kako čuvati Amaryl

6. Sadržaj pakiranja i druge informacije

1.

Što je Amaryl i za što se koristi

Amaryl je lijek djelotvoran za snižavanje razine šećera u krvi koji se uzima na usta. Pripada skupini

lijekova za snižavanje razine šećera u krvi koja se zove derivati sulfonilureje. Amaryl djeluje

povećanjem količine inzulina koja se otpušta iz gušterače. Inzulin tada snižava razinu šećera u krvi.

Za što se Amaryl koristi:

Amaryl se koristi za liječenje određenog tipa šećerne bolesti (šećerna bolest tipa 2) kad se razina

šećera u krvi ne može nadzirati pravilnom prehranom, tjelovježbom i smanjenjem tjelesne težine.

2. Što morate znati prije nego počnete uzimati Amaryl

Nemojte uzimati Amaryl:

ako ste alergični (preosjetljivi) na glimepirid ili druge derivate sulfonilureje (lijekovi koji se

koriste za snižavanje šećera u krvi kao što je glibenklamid) ili sulfonamide (lijekovi za bakterijske

infekcije kao što je sulfametoksazol) ili na neki drugi sastojak ovog lijeka (navedeni u dijelu 6.)

ako imate šećernu bolest ovisnu o inzulinu (šećerna bolest tipa 1)

ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti pri kojoj razina kiseline poraste u

organizmu i možete imati neke od sljedećih znakova: umor, osjećaj mučnine, učestalo mokrenje i

ukočenost mišića)

ako ste u dijabetičkoj komi

ako imate tešku bolest bubrega

ako imate tešku bolest jetre.

Ako se bilo što od gore navedenog odnosi na Vas, nemojte uzimati ovaj lijek. U slučaju bilo kakvih

nejasnoća prije uzimanja Amaryla razgovarajte sa svojim liječnikom ili ljekarnikom.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Amaryl:

ako se oporavljate od ozljede, operacije, infekcije s vrućicom ili od drugih oblika stresa,

obavijestite svog liječnika jer može biti potrebna privremena promjena liječenja

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ako imate težak poremećaj jetre ili bubrega.

Ako niste sigurni odnosi li se bilo što od gore navedenog na Vas, razgovarajte sa svojim liječnikom ili

ljekarnikom prije uzimanja Amaryla.

Snižavanje razine hemoglobina i raspadanje crvenih krvnih stanica (hemolitička anemija) mogu se

javiti u bolesnika kojima nedostaje enzim glukoza-6-fosfat dehidrogenaza.

Dostupni podaci o primjeni Amaryla u ljudi mlađih od 18 godina su ograničeni.

Zbog toga se primjena u tih bolesnika ne preporučuje.

Važne informacije o hipoglikemiji (niska razina šećera u krvi)

Kad uzimate Amaryl, možete dobiti hipoglikemiju (niska razina šećera u krvi). Za dodatne informacije

o hipoglikemiji, njenim znacima i simptomima, pogledajte dalje u tekstu.

Sljedeći čimbenici mogu povećati rizik od nastanka hipoglikemije:

pothranjenost, neredovito uzimanje, preskakanje ili odgađanje obroka ili razdoblje gladovanja

promjene u prehrani

uzimanje više Amaryla nego što je potrebno

smanjena funkcija bubrega

teška bolest jetre

određeni poremećaji uzrokovani hormonima (poremećaji štitnjače, hipofize ili kore nadbubrežne

žlijezde)

uzimanje alkohola (posebice kad se preskaču obroci)

uzimanje nekih drugih lijekova (pogledajte ispod u Drugi lijekovi i Amaryl)

povećanje tjelesne aktivnosti, nedovoljan unos hrane ili uzimanje hrane koja sadrži manje

ugljikohidrata od uobičajenog.

Znaci hipoglikemije uključuju:

grčeve od gladi, glavobolju, mučninu, povraćanje, tromost, pospanost, poremećaj spavanja, nemir,

agresiju, narušenu koncentraciju, smanjenu budnost i brzinu reagiranja, depresiju, smetenost,

poremećaje govora i vida, nerazgovjetan govor, drhtavicu, djelomičnu paralizu, poremećaje osjeta,

omaglicu, bespomoćnost

mogu se javiti i sljedeći znaci: znojenje, vlažna koža, tjeskoba, ubrzani srčani otkucaji, visoki

krvni tlak, osjećaji lupanja srca, iznenadna jaka bol u prsima koja se može širiti u susjedna

područja (angina pektoris i srčane aritmije).

Ako razina šećera u krvi nastavlja padati, možete patiti od jake smetenosti (delirij), razviti konvulzije,

izgubiti samokontrolu, disanje može biti plitko i srčani otkucaji usporeni, možete izgubiti svijest.

Klinička slika teškog smanjenja razine šećera u krvi može nalikovati moždanom udaru.

Liječenje hipoglikemije

U većini slučajeva znaci snižene razine šećera u krvi vrlo brzo nestaju kad se uzmu neki oblici šećera,

npr. kocke šećera, slatki sok, zaslađeni čaj.

Zbog toga uvijek sa sobom nosite neki oblik šećera (npr. kocke šećera).

Zapamtite da umjetni zaslađivači nisu učinkoviti. Ako uzimanje šećera ne pomaže ili se simptomi

vrate, obavijestite svojeg liječnika ili otiđite u bolnicu.

Laboratorijske pretrage

Redovito je potrebno kontrolirati razinu šećera u krvi ili mokraći. Vaš liječnik, također, može napraviti

krvne pretrage zbog kontrole broja krvnih stanica i funkcije jetre.

Djeca i adolescenti

Ne preporučuje se uporaba Amaryla u djece mlađe od 18 godina.

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Drugi lijekovi i Amaryl

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

druge lijekove.

Ako uzimate druge lijekove koji mogu oslabiti ili pojačati učinak Amaryla na razinu šećera u krvi, Vaš

će liječnik možda željeti promijeniti Vašu dozu Amaryla.

Sljedeći lijekovi mogu pojačati učinak Amaryla na snižavanje šećera u krvi. To može dovesti do rizika

od hipoglikemije (niska razina šećera u krvi):

ostali lijekovi za liječenje šećerne bolesti (kao što su inzulin ili metformin)

lijekovi za liječenje boli i upale (fenilbutazon, azopropazon, oksifenbutazon, lijekovi slični

aspirinu)

lijekovi za liječenje infekcija mokraćnog sustava (kao što su neki sulfonamidi dugog djelovanja)

lijekovi za liječenje bakterijskih i gljivičnih infekcija (tetraciklini, kloramfenikol, flukonazol,

mikonazol, kinoloni, klaritromicin)

lijekovi za sprječavanje zgrušavanja krvi (derivati kumarina kao što je varfarin)

lijekovi koji pomažu izgradnju mišića (anabolici)

lijekovi koji se koriste kao nadomjesna hormonska terapija za muškarce

lijekovi za liječenje depresije (fluoksetin, MAO-inhibitori)

lijekovi koji snižavaju visoku razinu kolesterola (fibrati)

lijekovi koji snižavaju visoki krvni tlak (ACE inhibitori)

lijekovi koji se zovu antiaritmici, a koriste se za kontrolu nenormalnog srčanog ritma

(dizopiramid)

lijekovi za liječenje gihta (alopurinol, probenecid, sulfinpirazon)

lijekovi za liječenje karcinoma (ciklofosfamid, ifosfamid, trofosfamid)

lijekovi koji se koriste za smanjenje tjelesne težine (fenfluramin)

lijekovi koji poboljšavaju cirkulaciju kad se daju intravenskom infuzijom u visokoj dozi

(pentoksifilin)

lijekovi za liječenje nazalnih alergija kao što je peludna groznica (tritokvalin)

lijekovi koji se zovu simpatolitici za liječenje visokog krvnog tlaka, zatajivanja srca ili simptoma

prostate.

Sljedeći lijekovi mogu umanjiti učinak Amaryla na snižavanje šećera u krvi. To može dovesti do

rizika od hiperglikemije (visoka razina šećera u krvi):

lijekovi koji sadrže ženske spolne hormone (estrogeni, progesteroni)

lijekovi koji pomažu stvaranje mokraće (tiazidni diuretici)

lijekovi koji se koriste za poticanje rada štitnjače (kao što je levotiroksin)

lijekovi za liječenje alergija i upala (glukokortikoidi)

lijekovi za liječenje teških psihičkih poremećaja (klorpromazin i ostali derivati fenotiazina)

lijekovi koji se koriste za poticanje srčanih otkucaja, liječenje astme ili začepljenosti nosa, kašlja i

prehlade, smanjenje tjelesne težine ili u hitnim stanjima opasnim po život (adrenalin i

simpatomimetici)

lijekovi za liječenje visoke razine kolesterola (nikotinska kiselina)

lijekovi za liječenje konstipacije pri dugotrajnoj primjeni (laksativi)

lijekovi za liječenje epileptičkih napadaja (fenitoin)

lijekovi za liječenje nervoze i problema sa spavanjem (barbiturati)

lijekovi za liječenje povišenog očnog tlaka (azetazolamid)

lijekovi za liječenje visokog krvnog tlaka ili snižavanje razine šećera u krvi (diazoksid)

lijekovi za liječenje infekcija, tuberkuloze (rifampicin)

lijekovi za liječenje izrazito niske razine šećera u krvi (glukagon).

Sljedeći lijekovi mogu pojačati ili umanjiti učinak Amaryla na snižavanje šećera u krvi:

lijekovi za liječenje želučanog vrijeda (zvani H2 antagonisti)

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lijekovi za liječenje visokog krvnog tlaka ili srčanog zatajivanja kao što su beta-blokatori,

klonidin, gvanetidin i rezerpin. Ti lijekovi, također, mogu prikriti znakove hipoglikemije, pa je pri

njihovoj primjeni potrebna posebna pažnja.

Amaryl može ili pojačati ili umanjiti učinak sljedećih lijekova:

lijekovi koji sprječavaju zgrušavanje krvi (derivati kumarina kao što je varfarin)

Kolesevelam, lijek koji se koristi za smanjenje kolesterola, ima učinak na apsorpciju Amaryla. Da

biste izbjegli taj učinak, trebali bi Vam savjetovati da uzimate Amaryl najmanje 4 sata prije

kolesevelama.

Amaryl s hranom, pićem i alkoholom

Uzimanje alkohola može, na nepredvidljiv način, pojačati ili umanjiti djelovanje Amaryla na

snižavanje razine šećera u krvi.

Trudnoća i dojenje

Trudnoća

Amaryl se ne smije uzimati tijekom trudnoće. Obavijestite svojeg liječnika ako ste trudni, mislite da

ste trudni ili planirate zatrudnjeti.

Dojenje

Amaryl može prijeći u majčino mlijeko. Amaryl se ne smije uzimati tijekom dojenja.

Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Upravljanje vozilima i strojevima

Ako Vam je razina šećera u krvi snižena (hipoglikemija) ili povišena (hiperglikemija) ili su Vam se,

kao rezultat takvih stanja, razvili problemi s vidom, Vaša sposobnost koncentracije i reakcije može biti

oslabljena. Imajte na umu da možete ugroziti sebe ili druge (npr. pri vožnji automobila ili upravljanju

strojevima). Pitajte svojeg liječnika možete li upravljati vozilom:

ako imate česte epizode hipoglikemije,

ako imate manje ili uopće nemate upozoravajuće znakove hipoglikemije.

Amaryl sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, obavijestite svojeg liječnika prije uzimanja

ovog lijeka.

3. Kako uzimati Amaryl

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

Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.

Uzimanje lijeka

Ovaj lijek uzmite kroz usta, neposredno prije ili za vrijeme prvog glavnog obroka u danu (obično

doručak). Ako ne doručkujete uzmite lijek prema rasporedu koji Vam je propisao liječnik. Kad

uzimate Amaryl, važno je ne preskočiti niti jedan obrok.

Progutajte tabletu s najmanje pola čaše vode. Tabletu nemojte drobiti ili žvakati.

Koliko lijeka uzeti

Doza Amaryla ovisi o Vašim potrebama, stanju i rezultatima testiranja šećera u krvi i mokraći, a dozu

određuje Vaš liječnik. Nemojte uzeti više tableta nego što Vam je liječnik propisao.

Uobičajena početna doza iznosi jednu tabletu Amaryla od 1 mg (što iznosi pola tablete od 2 mg)

jednom dnevno.

Po potrebi, liječnik može povećati dozu nakon svakih 1-2 tjedna liječenja.

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Najveća preporučena doza iznosi 6 mg Amaryla dnevno.

Može se uvesti kombinirano liječenje glimepiridom i metforminom ili glimepiridom i inzulinom.

U tom slučaju liječnik će posebno za Vas odrediti potrebnu dozu glimepirida, metformina ili

inzulina.

Obavijestite Vašeg liječnika ako Vam se mijenja težina ili životne navike ili ako ste u stresnoj

situaciji jer to može zahtijevati promjenu doze Amaryla.

Ako osjećate da je učinak lijeka preslab ili prejak, nemojte sami mijenjati dozu nego se obratite

svome liječnika.

Ako uzmete više Amaryla nego što ste trebali

Ako ste uzeli previše Amaryla ili dodatnu dozu, postoji opasnost od hipoglikemije (za znake

hipoglikemije pogledajte dio 2.). Zbog toga morate odmah uzeti dovoljnu količinu šećera (npr. kocku

šećera, slatki sok, zaslađeni čaj) te odmah obavijestiti liječnika. Pri liječenju hipoglikemije u djece do

koje je došlo zbog nehotičnog unosa lijeka, količina danog šećera mora biti pažljivo kontrolirana da bi

se izbjegla mogućnost nastanka opasne hiperglikemije. Osobama u nesvjesnom stanju ne smiju se

davati hrana ili piće.

Budući da stanje hipoglikemije može trajati neko vrijeme, vrlo je važno pažljivo pratiti bolesnika sve

dok više ne bude opasnosti. Također, kao mjera opreza može biti nužan i prijem u bolnicu. Pokažite

liječniku pakiranje ili preostale tablete kako bi znao što je uzeto.

Teški slučajevi hipoglikemije, praćeni gubitkom svijesti i teškim neurološkim zatajivanjem hitni su

medicinski slučajevi i zahtijevaju hitno medicinsko liječenje i prijem u bolnicu. Trebalo bi osigurati da

uvijek postoji osoba koja zna da u slučaju hitnosti treba pozvati liječnika.

Ako ste zaboravili uzeti Amaryl

Ako ste zaboravili uzeti dozu nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu.

Ako prestanete uzimati Amaryl

Ako prekinete ili potpuno prestanete liječenje morate biti svjesni da željeni učinak na snižavanje

razine šećera u krvi nije postignut ili da će se bolest ponovno pogoršati. Nastavite uzimati Amaryl dok

Vam liječnik ne kaže da prestanete.

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

4. Moguće nuspojave

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

Odmah obavijestite svojeg liječnika ako osjetite neki od sljedećih simptoma:

alergijske reakcije (uključujući upalu krvnih žila, često s kožnim osipom) koje se mogu razviti u

ozbiljne reakcije s poteškoćama pri disanju, padom krvnog tlaka, te, ponekad, napredovati do šoka

abnormalna funkcija jetre, uključujući žutilo kože i očiju (žutica), probleme s protokom žuči

(kolestaza), upala jetre (hepatitis) ili zatajenje jetre

alergija (preosjetljivost) kože kao što je svrbež, osip, koprivnjača i povećana osjetljivost na sunce.

Neke blage alergijske reakcije mogu se razviti u ozbiljne reakcije.

teška hipoglikemija uključujući gubitak svijesti, epileptičke napadaje ili komu.

Neki su bolesnici tijekom uzimanja Amaryla osjetili sljedeće nuspojave:

Rijetke nuspojave

(pojavljuju se u manje od 1 na 1000 bolesnika)

Niža razina šećera u krvi od normalne (hipoglikemija) (pogledajte dio 2.)

Sniženje broja krvnih stanica:

trombocita (veći rizik od krvarenja ili stvaranja modrica)

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leukocita (veća sklonost infekcijama)

eritrocita (blijeda boja kože, slabost, nedostatak zraka).

Ovi se problemi obično poprave nakon prestanka uzimanja Amaryla.

Vrlo rijetke nuspojave

(pojavljuju se u manje od 1 na 10 000 bolesnika)

Alergijske reakcije (uključujući upalu krvnih žila, često s kožnim osipom) koje se mogu razviti u

ozbiljne reakcije s poteškoćama pri disanju, padom krvnog tlaka, te, ponekad, napredovati do

šoka. Ako osjetite bilo koji od ovih simptoma,

odmah o tome obavijestite svojeg liječnika.

abnormalna funkcija jetre uključujući žutilo kože i očiju (žutica), narušen protok žuči (kolestaza),

upala jetre (hepatitis) ili zatajenje jetre. Ako osjetite bilo koji od ovih simptoma,

odmah o tome

obavijestite svojeg liječnika.

Osjećaj mučnine ili mučnina, proljev, osjećaj punoće ili nadutosti i bol u trbuhu.

Smanjenje razine natrija u krvi (dokazuje se krvnom pretragom).

Ostale nuspojave

Alergija (preosjetljivost) kože može se javiti u obliku svrbeža, osipa, koprivnjače i povećane

osjetljivosti na sunce. Neke blage alergijske reakcije mogu se razviti u ozbiljne reakcije s

problemima gutanja ili disanja, oticanjem usnica, grla i jezika. Stoga u slučaju jedne od ovih

nuspojava

odmah obavijestite svog liječnika.

Alergijske reakcije sa sulfonilurejama, sulfonamidima ili srodnim lijekovima mogu nastati.

Problemi s vidom mogu se javiti na početku liječenja Amarylom. Do toga dolazi zbog promjene

razine šećera u krvi i trebalo bi se brzo poboljšati.

Povećani jetreni enzimi.

Teško neuobičajeno krvarenje ili modrice ispod kože.

Prijavljivanje nuspojava

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

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

izravno putem:

Agencije za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju

Roberta Frangeša Mihanovića 9

10 000 Zagreb

Republika Hrvatska

faks: + 385 (0)1 4884 119

mrežne stranice: www.halmed.hr

e-mail: nuspojave@halmed.hr.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Amaryl

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza ''Rok

valjanosti''. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Ne čuvati na temperaturi iznad 30°C.

Čuvati u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove kvarenja.

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.

H A L M E D

29 - 01 - 2015

O D O B R E N O

6. Sadržaj pakiranja i druge informacije

Što Amaryl sadrži

Djelatna tvar je glimepirid.

Jedna tableta sadrži 2 mg ili 3 mg glimepirida ovisno o jačini navedenoj na blisteru i kutiji.

Drugi sastojci su: laktoza hidrat, natrijev škroboglikolat vrste A, magnezijev stearat,

mikrokristalična celuloza, povidon 25000.

Osim toga, tablete sadrže bojila:

2 mg tablete sadrže žuti željezov oksid (E172) i

indigo-carmine aluminium lake

(E132),

3 mg tablete sadrže žuti željezov oksid (E172)

Kako Amaryl izgleda i sadržaj pakiranja

Tableta Amaryla je duguljasta i ima razdjelnu crtu s obje strane. Tableta se može razdijeliti na jednake

doze. Boje su različite:

2 mg tablete su zelene

3 mg tablete su blijedo žute

Tablete su pakirane u blister pakiranjima s 30 i 90 tableta. Na tržištu se ne moraju nalaziti sve veličine

pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

sanofi-aventis Croatia d.o.o.

Heinzelova 70

10000 Zagreb

Proizvođač

Sanofi-Aventis S.p.A.

Strada Statale 17, Km 22

67019 Scoppito (L'Aquila)

Italija

Sanofi Winthrop Industrie

30-36 avenue Gustave Eiffel

37100 Tours

Francuska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u siječnju 2015.

H A L M E D

29 - 01 - 2015

O D O B R E N O

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

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

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

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

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

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

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

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

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

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

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

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

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

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

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

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

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

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

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

22-11-2018

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

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

Published on: Wed, 21 Nov 2018 Following a request from the 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency