Zoprax 20 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Zoprax 20 mg želučanootporne tablete
  • Doziranje:
  • 20 mg
  • Farmaceutski oblik:
  • želučanootporna tableta
  • Sastav:
  • Urbroj: jedna želučanootporna tableta sadrži 20 mg pantoprazola u obliku pantoprazolnatrij seskvihidrata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Zoprax 20 mg želučanootporne tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-817038719-01]; 56 tableta u blisteru, u kutiji [HR-H-817038719-02] Urbroj: 381-12-01/70-15-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-817038719
  • Datum autorizacije:
  • 28-11-2015
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Zoprax 20 mg želučanootporne tablete

pantoprazol

Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati 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 štetiti, čak i

ako imaju simptome jednake Vašima.

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.

Što se nalazi u ovoj uputi:

Što je Zoprax i za što se koristi?

Što morate znati prije nego počnete uzimati Zoprax?

Kako uzimati Zoprax?

Moguće nuspojave

Kako čuvati Zoprax?

Sadržaj pakiranja i druge informacije

1.

Što je Zoprax i za što se koristi?

Zoprax je selektivni „inhibitor protonske pumpe“, lijek koji smanjuje količinu kiseline koja

se stvara u želucu. Koristi se za liječenje bolesti želuca i crijeva uzrokovanih kiselinom.

Zoprax se koristi u odraslih i djece starije od 12 godina za:

liječenje simptoma (kao što su žgaravica, vraćanje kiselog sadržaja iz želuca u usta,

bol pri gutanju)

povezanih s gastroezofagealnom refluksnom bolesti uzrokovanom

vraćanjem kiselog sadržaja iz želuca u jednjak (cijev koja povezuje grlo i želudac),

dugotrajno liječenje refluksnog ezofagitisa (upale jednjaka popraćene vraćanjem

kiselog sadržaja iz želuca u usta) i sprječavanje povratka bolesti.

Zoprax se koristi u odraslih za:

sprječavanje vrijedova (čira) na želucu i dvanaesniku uzrokovanih nesteroidnim

protuupalnim lijekovima (NSAIL, lijekovi poput ibuprofena) u rizičnih bolesnika

kojima je potrebno kontinuirano liječenje takvim lijekovima kroz dulje razdoblje.

2.

Što morate znati prije nego počnete uzimati Zoprax?

Nemojte uzimati Zoprax:

ako ste alergični na djelatnu tvar ili bilo koji drugi sastojak ovog lijeka (naveden u

dijelu 6.)

ako ste alergični na druge lijekove iz skupine inhibitora protonske pumpe.

H A L M E D

28 - 11 - 2015

O D O B R E N O

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Zoprax:

ako imate teške probleme s jetrom. Recite liječniku ako ste ikad u prošlosti patili od

jetrenih tegoba. U tom će Vam slučaju liječnik češće provjeravati jetrene enzime u

krvi, osobito ako Zoprax koristite kroz duži vremenski period. U slučaju porasta

jetrenih enzima liječenje se mora prekinuti.

ako kontinuirano koristite lijekove iz skupine NSAIL (nesteroidni protuupalni

lijekovi) i preporučen Vam je Zoprax jer zbog NSAIL imate povećani rizik razvoja

želučanih

crijevnih

komplikacija.

Povećani

rizik

treba

procijeniti

temeljem

čimbenika rizika svakog pojedinca, poput dobi (imate 65 ili više godina) ili u

povijesti bolesti imate zabilježen vrijed (čir) na želucu ili dvanaesniku ili krvarenje

iz probavnog trakta.

ako ste na dugotrajnoj terapiji Zopraxom, a imate smanjene zalihe vitamina B12 ili

čimbenike rizika za smanjenje količine vitamina B12. Pantoprazol, kao i drugi

blokatori lučenja želučane kiseline, može smanjiti apsorpciju vitamina B12.

ako istodobno uzimate lijek koji sadrži atazanavir (koristi se za liječenje HIV

infekcija). Obratite se svom liječniku za savjet.

ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim Zopraxu koji

smanjuje želučanu kiselinu.

Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite

svojeg

liječnika

što

prije

moguće,

ćete

možda

morati

prekinuti

liječenje

Zopraxom. Sjetite se spomenuti i bilo koje druge štetne učinke poput boli u zglobovima

Odmah se javite liječniku ako primijetite neki od navedenih simptoma:

nenamjerni gubitak tjelesne težine,

povraćanje koje se ponavlja,

teškoće s gutanjem,

povraćanje krvi,

blijeda koža ili sluznice i slabost (anemija),

krv u stolici,

težak

i/ili

dugotrajan

proljev,

pantoprazol

povezan

blagim

porastom

učestalosti zaraznih proljeva.

Liječnik će Vas možda uputiti na dodatne pretrage kojima bi se isključilo postojanje

zloćudne

bolesti

liječenje

pantoprazolom

može

ublažiti

simptome

odgoditi

postavljanje dijagnoze. Ako se simptomi nastave unatoč terapiji, možda će biti potrebno

razmotriti daljnje pretrage.

Kod dugotrajnog liječenja, naročito ako traje dulje od godine dana, liječnik će Vas

vjerojatno redovito kontrolirati. Ako primijetite nove ili neuobičajene simptome, morate

obavijestiti liječnika.

Uzimanje inhibitora protonske pumpe kao što je Zoprax, osobito tijekom vremenskog

perioda duljeg od godinu dana, može blago povećati rizik od prijeloma kuka, zapešća ili

kralježnice.

Obavijestite

svog

liječnika

bolujete

osteoporoze

uzimate

kortikosteroide (koji mogu povećati rizik od osteoporoze).

H A L M E D

28 - 11 - 2015

O D O B R E N O

Drugi lijekovi i Zoprax

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

bilo koje druge lijekove.

Zoprax može imati utjecaj na učinkovitost drugih lijekova, stoga obavijestite liječnika ako

uzimate:

lijekove kao što su ketokonazol, itrakonazol i posakonazol (koriste se za liječenje

gljivičnih infekcija) ili erlotinib (koristi se za liječenje određenih oblika raka),

atazanavir (koristi se u liječenju infekcije HIV-om),

varfarin ili fenprokumon (koriste se za prorjeđivanje krvi i sprječavanje ugrušaka).

Možda ćete trebati daljnje pretrage.

metotreksat (koristi se za liječenje reumatoidnog artritisa, psorijaze i raka). Ako

uzimate metotreksat liječnik može privremeno prekinuti Vaše liječenje Zoprax

tabletama.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se

svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Nema

odgovarajućih

podataka

upotrebi

pantoprazola

trudnoći.

Zabilježeno

izlučivanje u majčino mlijeko.

Ovaj lijek smijete uzimati samo ako liječnik procjeni da je korist za Vas veća

potencijalnog rizika za plod/dijete.

Upravljanje vozilima i strojevima

Ukoliko

primijete

nuspojave

poput

omaglice

poremećaja

vida,

tijekom

liječenja

Zopraxom, ne smijete upravljati vozilima niti raditi sa strojevima.

3.

Kako uzimati Zoprax?

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

Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.

Tabletu trebate progutati cijelu s vodom, jedan sat prije obroka. Nemojte žvakati ili lomiti

tabletu.

Ako liječnik nije drugačije odredio uobičajene doze su:

Odrasli i djeca starija od 12 godina:

Liječenje simptoma (kao što su žgaravica, vraćanje kiselog sadržaja iz želuca u usta, bol

pri gutanju) povezanih s gastroezofagealnom refluksnom bolesti

Preporučena doza je jedna tableta

Zoprax 20 mg

dnevno.

Poboljšanje simptoma obično se postiže tijekom 2 do 4 tjedna, a najviše za još sljedeća 4

tjedna. Liječnik će odlučiti koliko dugo trebate uzimati terapiju.

Kada se simptomi povuku, njihovo ponovno pojavljivanje može se kontrolirati uzimanjem

jedne Zoprax 20 mg tablete na dan, po potrebi.

H A L M E D

28 - 11 - 2015

O D O B R E N O

Dugotrajno liječenje refluksnog ezofagitisa (vraćanje kiselog sadržaja iz želuca u usta) i

sprječavanje povratka bolesti

Preporučena doza je jedna tableta Zoprax 20 mg dnevno.

Ako se bolest vrati, liječnik može udvostručiti dozu. Za takve slučajeve postoje i Zoprax

40 mg tablete, jedna tableta dnevno. Nakon izlječenja doza se ponovno može smanjiti na

jednu tabletu od 20 mg na dan.

Odrasli:

Sprječavanje vrijeda (čira) na želucu i dvanaesniku (dio tankog crijeva) u bolesnika koji

trebaju kontinuirano liječenje nesteroidnim antireumaticima (NSAIL)

Preporučena doza je jedna tableta

Zoprax 20

mg dnevno.

Bolesnici s oštećenjem funkcije jetre

Ako patite od teških

jetrenih tegoba, ne smijete uzeti više od jedne tablete od 20 mg na

dan.

Primjena u djece i adolescenata

Primjena ovog lijeka ne preporučuje se u djece mlađe od 12 godina

.

Ako uzmete više Zopraxa nego što ste trebali

Obavijestite svog liječnika ili ljekarnika. Simptomi predoziranja nisu poznati.

Ako ste zaboravili uzeti Zoprax

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Sljedeću dozu

uzmite u uobičajeno vrijeme.

Ako prestanete uzimati Zoprax

Nemojte prestati uzimati ove tablete bez da ste se prvo posavjetovali sa svojim liječnikom

ili ljekarnikom.

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.

Ako primijetite bilo koju od sljedećih nuspojava, prestanite uzimati ovaj lijek i

odmah obavijestite svog liječnika ili se javite u najbližu zdravstvenu ustanovu:

Ozbiljne alergijske reakcije

(rijetke, mogu se javiti u manje od 1 na 1000 osoba):

oticanje jezika i/ili grla, teškoće pri gutanju, koprivnjača (urtikarija), teškoće pri

disanju, alergijsko oticanje lica (Quinckeov edem/angioedem), jaka omaglica s vrlo

brzim lupanjem srca i jakim znojenjem.

Ozbiljna kožna stanja

(nepoznato: učestalost se ne može procijeniti iz dostupnih

podataka):

H A L M E D

28 - 11 - 2015

O D O B R E N O

stvaranje mjehura na koži i ubrzano pogoršanje općeg stanja,

oštećenja sluznica

koja mogu biti praćena blagim krvarenjima (erozije) očiju, nosa, usta/usana ili

genitalija (Stevens-Johnsonov sindrom, Lyellov sindrom, multiformni eritem) i

osjetljivost na svjetlost.

Ostala ozbiljna stanja (

nepoznato: učestalost se ne može procijeniti iz dostupnih

podataka):

žutilo kože ili bjeloočnica (žutica, teško oštećenje stanica jetre) ili vrućica, osip,

zbog upale mogu biti povećani bubrezi ponekad praćeni bolnim mokrenjem i boli u

donjem dijelu leđa (ozbiljna upala bubrega).

Ostale nuspojave:

Manje često

(mogu se javiti u manje od 1 na 100 osoba):

glavobolja, omaglica, proljev, mučnina, povraćanje, nadutost i vjetrovi, zatvor,

suha usta, bol i neugoda u trbuhu, osip na koži, izbijanje kožnih promjena

koje se

očituju svrbežom i crvenilom (egzantem), svrbež, osjećaj slabosti, iscrpljenost i

opće loše osjećanje, poremećaji spavanja, prijelom kuka, zapešća ili kralježnice.

Rijetko

(mogu se javiti u manje od 1 na 1000 osoba): poremećaj ili potpuni

nestanak osjeta okusa, smetnje vida kao što je zamagljen vid, koprivnjača, bol u

zglobovima,

mišićima,

promjene

tjelesnoj

težini,

povišena

tjelesna

temperatura, nakupljanje tekućine u stopalima i nogama, obično oko gležnjeva

(periferni edem), alergijske reakcije, depresija, povećanje dojki u muškaraca.

Vrlo rijetko

(mogu se javiti u manje od 1 na 10 000 osoba):

dezorijentiranost.

Nepoznato

(učestalost se ne može procijeniti iz dostupnih podataka): halucinacije

(vidite, čujete ili osjećate stvari koje ne postoje), smetenost (pogotovo u bolesnika

koji su imali te simptome), osjećaj trnjenja, bockanja, mravinjanja, žarenja ili

utrnulosti u nekom dijelu tijela (parestezije), grč u mišićima, smanjene razine

natrija u krvi (može uzrokovati slabost i grčenje mišićima ili nenormalan srčani

ritam),

osip,

moguće

praćen

boli

zglobovima,

smanjene

razine

kalcija.Ako

uzimate Zoprax dulje od tri mjeseca, može doći do smanjenja razine magnezija u

krvi. Niske razine magnezija mogu se očitovati kao umor, nevoljno stezanje mišića,

dezorijentiranost, konvulzije, omaglica, ubrzan rad srca. Ako primijetite bilo koji

od ovih simptoma, odmah obavijestite svog liječnika.

Niske razine magnezija mogu također dovesti do smanjenja razine kalija ili kalcija

u krvi. Vaš liječnik može odlučiti da je potrebno provoditi redovite krvne pretrage

kako bi se nadzirala razina magnezija u krvi.

Nuspojave koje se otkrivaju krvnim pretragama:

Manje često

(mogu se javiti u manje od 1 na 100 osoba):

povišenje jetrenih enzima

Rijetko

(mogu se javiti u manje od 1 na 1000 osoba):

povišenje bilirubina, povišenje razina masnoća u krvi (kolesterola i triglicerida),

naglo smanjenje broja granulocita - vrste bijelih krvnih stanica praćeno visokom

vrućicom (agranulocitoza).

H A L M E D

28 - 11 - 2015

O D O B R E N O

Vrlo rijetko

(mogu se javiti u manje od 1 na 10 000 osoba):

smanjenje

broja

krvnih

pločica,

što

može

izazvati

neuobičajena

krvarenja

stvaranja modrica; smanjenje broja bijelih krvnih stanica što može dovesti do

učestalih infekcija, istodobno abnormalno smanjenje broja crvenih (eritrocita) i

bijelih (leukocita) krvnih stanica, te krvnih pločica (trombocita).

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 Zoprax?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30°C.

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

oznake EXP.

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 Zoprax sadrži?

Djelatna tvar je pantoprazol.

Jedna tableta sadrži 20 mg pantoprazola u obliku pantoprazolnatrij seskvihidrata.

Pomoćne tvari su: natrijev hidrogenfosfat, bezvodni; manitol; celuloza, mikrokristalična;

karmelozanatrij,

umrežena;

magnezijev

stearat;

hipromeloza;

trietilcitrat;

natrijev

škroboglikolat,

vrst

metakrilna

kiselina/etilakrilat

kopolimer

1:1,

raspršina;

željezov oksid, žuti (E172); voda, pročišćena.

Kako Zoprax izgleda i sadržaj pakiranja?

Žuta, ovalna, bikonveksna, glatka, želučanootporna tableta dimenzija 8 mm x 5,5 mm.

Dostupan

pakiranjima

(4x7)

želučanootpornih

tableta

(8x7)

želučanootpornih tableta u blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

JADRAN-GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka

H A L M E D

28 - 11 - 2015

O D O B R E N O

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u studenom 2015.

H A L M E D

28 - 11 - 2015

O D O B R E N O

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Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

6-8-2018

Otezla (Celgene Europe B.V.)

Otezla (Celgene Europe B.V.)

Otezla (Active substance: apremilast) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5391 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3746/T/20

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration