Acipan 20 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Acipan 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:
  • Lek Pharmaceuticals d.d., Ljubljana, Slovenija; Salutas Pharma GmbH, Barleben, Njemačka; Lek S.A., Varšava, Poljska; Lek Phar

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-654438627-01]; 56 tableta u blisteru, u kutiji [HR-H-654438627-02] Urbroj: 381-12-01/70-14-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-654438627
  • Datum autorizacije:
  • 28-10-2014
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Acipan 20 mg želučanootporne tablete

pantoprazol

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

podatke.

Sačuvajte ovu uputu. Moţda ćete je trebati ponovo pročitati.

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

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

su njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

1. Što je Acipan 20 mg i za što se koristi?

2. Što morate znati prije nego počnete uzimati Acipan 20 mg?

3. Kako uzimati Acipan 20 mg?

4. Moguće nuspojave

5. Kako čuvati Acipan 20 mg?

6. Sadrţaj pakiranja i druge informacije

1. Što je Acipan 20 mg i za što se koristi?

Acipan 20 mg je selektivni ''inhibitor protonske pumpe'', lijek koji smanjuje količinu kiseline koja se

stvara u Vašem ţelucu. Koristi se za liječenje bolesti ţeluca i crijeva uzrokovanih kiselinom.

Acipan 20 mg se koristi za:

Kod odraslih i djece starije od 12 godina:

liječenje simptoma (kao što su ţgaravica, vraćanje kiselog sadrţaja iz ţeluca u usta, bol pri

gutanju)

povezanih

gastroezofagealnom

refluksnom

bolesti

uzrokovanom

vraćanjem

kiselog sadrţaja iz ţeluca u jednjak.

dugotrajno liječenje refluksnog ezofagitisa (upala jednjaka popraćena vraćanjem kiselog

sadrţaja iz ţeluca u usta) i sprječavanje povratka bolesti

Kod odraslih:

prevenciju ulkusa ţeluca i dvanaesnika uzrokovanih nesteroidnim antireumaticima (NSAR,

npr. ibuprofen) kod rizičnih bolesnika kojima je potrebno kontinuirano liječenje s NSAR

2. Što morate znati prije nego počnete uzimati Acipan 20 mg?

Nemojte uzimati tablete Acipan 20 mg:

ako ste alergični na djelatnu tvar (pantoprazol) ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.)

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

Upozorenje i mjere opreza

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Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Acipan 20 mg tablete:

ako imate teške jetrene tegobe. Recite liječniku ako ste ikad u prošlosti patili od jetrenih

tegoba. U tom ćete slučaju češće provjeravati jetrene enzime, osobito ako Acipan 20 mg

koristite kroz duţi vremenski period. U slučaju porasta jetrenih enzima liječenje se mora

prekinuti.

ako kontinuirano trebate koristiti lijekove iz skupine NSAR i preporučen Vam je pantoprazol,

zbog

nesteroidnih

antireumatika

imate

povećani

rizik

razvoja

ţelučanih

crijevnih

komplikacija. Povećani rizik treba procijeniti temeljem individualnih čimbenika rizika, poput

dobi (imate 65 ili više godina), anamneze ulkusa ţeluca ili dvanaesnika ili krvarenja iz

probavnog trakta.

ako ste na dugotrajnoj terapiji Acipanom 20 mg, a imate smanjene zalihe vitamina B12 ili

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

lučenja ţelučane kiseline, moţe smanjiti apsorpciju vitamina B12.

ako istodobno uzimate lijek koji sadrţi atazanavir (za liječenje HIV infekcija). Upitajte

liječnika za savjet

ako ste ikad imali koţnu reakciju nakon terapije s lijekom sličnim tabletama Acipan 20 mg

koji smanjuje ţelučanu kiselinu

morate napraviti određenu krvnu pretragu (kromogranin A).

Odmah se javite liječniku ako primijetite neke od navedenih simptoma:

nenamjerni gubitak teţine

povraćanje koje se ponavlja

teškoće s gutanjem

povraćanje krvi

blijedi ste i osjećate slabost (anemija)

primijetili ste krv u stolici

teţak i/ili dugotrajan proljev, jer je Acipan 20 mg povezan s blagim porastom učestalosti

infektivnih proljeva.

Liječnik će Vas moţda uputiti na dodatne pretrage da bi se isključila zloćudna bolest, jer pantoprazol

moţe ublaţiti simptome raka i odgoditi njegovo otkrivanje. Ako se simptomi nastavljaju unatoč

terapiji, moţda 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 Acipan 20 mg, osobito tijekom vremenskog perioda

duljeg od godinu dana, moţe blago povećati rizik od prijeloma kuka, zapešća ili kraljeţnice.

Obavijestite svog liječnika ako bolujete od osteoporoze ili ako uzimate kortikosteroide (koji mogu

povećati rizik od osteoporoze).

Ako dobijete osip na koţi, posebice na područjima izloţenima suncu obavijestite svojeg liječnika što

je prije moguće, jer ćete moţda morati prekinuti liječenje tabletama Acipan 20 mg. Sjetite se

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

Drugi lijekovi i Acipan 20 mg

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

koje druge lijekove.

Acipan 20 mg moţe utjecati 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), jer Acipan 20 mg moţe

spriječiti pravilno djelovanje tih i drugih lijekova

varfarin ili fenprokumon, koji se koriste za prorjeđivanje krvi i sprječavanje ugrušaka.

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Moţda ćete trebati daljnje pretrage.

atazanavir (koristi se za liječenje HIV infekcija)

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

metotreksat doktor moţe privremeno prekinuti Vaše liječenje tabletama Acipan 20 mg.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Nema odgovarajućih podataka o upotrebi pantoprazola u trudnoći. Zabiljeţeno je izlučivanje u

majčino mlijeko. Ako ste trudni, mislite da ste trudni ili dojite, ovaj lijek uzimajte samo ako liječnik

procijeni da je korist za Vas veća od potencijalnog rizika za plod/dijete.

Upravljanje vozilima i strojevima

Ukoliko primijetite nuspojave poput omaglice ili poremećaja vida, ne smijete upravljati vozilima niti

raditi sa strojevima.

Acipan 20 mg tablete sadrže boju Ponceau 4R

Boja moţe uzrokovati alergijske reakcije.

3. Kako uzimati Acipan 20 mg?

Uvijek uzimajte Acipan 20 mg tablete točno onako kako Vam je rekao Vaš liječnik ili ljekarnik.

Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.

Kako i kada uzimati Acipan 20 mg?

Tablete uzimajte jedan sat prije obroka. Progutajte ih cijele, bez ţvakanja ili lomljenja, s malo

tekućine.

Ako liječnik nije drugačije odredio uobičajene doze su:

Odrasli i djeca starija od 12 godina:

Liječenje simptoma (kao što su ţgaravica, vraćanje kiselog sadrţaja iz ţeluca u usta, bol pri gutanju)

povezanih s gastroezofagealnom refluksnom bolesti

Uobičajena doza je jedna tableta na dan. Olakšanje simptoma s ovom dozom najčešće nastupa za dva

do četiri tjedna, a najviše za još sljedeća četiri tjedna. Liječnik će odlučiti koliko dugo trebate uzimati

terapiju. Nakon toga se povrat simptoma moţe suzbijati uzimanjem jedne tablete na dan, po potrebi.

Dugotrajno liječenje refluksnog ezofagitisa i spriječavanje povrata refluksnog ezofagitisa

Uobičajena doza je jedna tableta na dan. Ako se bolest vrati, liječnik moţe udvostručiti dozu. Za

takve slučajeve postoje i Acipan 40 mg tablete, jedna tableta dnevno. Nakon izlječenja doza se

ponovno moţe smanjiti na jednu tabletu od 20 mg na dan.

Odrasli

Prevencija ulkusa ţeluca i dvanaesnika u bolesnika koji trebaju kontinuiranu terapiju sa NSAR

Uobičajena doza je jedna tableta na dan.

Posebne grupe bolesnika:

Ako patite od teških jetrenih tegoba, ne smijete uzeti više od jedne tablete od 20 mg na dan.

Djeca mlađa od 12 godina. Primjena ovih tableta u djece mlađe od 12 godina se ne

preporučuje.

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Ako uzmete više tableta Acipan 20 mg nego što ste trebali:

Obavijestite liječnika ili ljekarnika. Simptomi predoziranja nisu poznati.

Ako ste zaboravili uzeti Acipan 20 mg tablete:

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

uobičajeno vrijeme.

Ako prestanete uzimati Acipan 20 mg tablete:

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

ljekarnikom.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4. Moguće nuspojave

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

Učestalost mogućih nuspojava označava se sljedećim kategorijama:

Vrlo često: javljaju se kod više od 1 na 10 osoba

Često: javljaju se kod više od 1 na 100 osoba

Manje često: javljaju se kod više od 1 na 1000 osoba

Rijetko: javljaju se kod manje od 1 na 1000 osoba

Vrlo rijetko: javljaju se kod manje od 1 na 10 000 osoba

Nepoznato: ne moţe se procijeniti iz dostupnih podataka

Ako

primijetite

bilo

koju

od

sljedećih

nuspojava,

prestanite

uzimati

tablete

i

odmah

obavijestite svog liječnika ili se javite u najbližu zdravstvenu ustanovu:

ozbiljne alergijske reakcije (rijetke učestalosti): 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

(nepoznate

učestalosti):

stvaranje

mjehura

koţi

ubrzano

pogoršanje općeg stanja, erozije (uključujući blaga krvarenja) očiju, nosa, usta/usana ili

genitalija (Stevens-Johnsonov sindrom, Lyellov sindrom, multiformni eritem) te osjetljivost

na svjetlost.

ostala ozbiljna stanja (nepoznate učestalosti): ţutilo koţe ili bjeloočnica (ţutica, teško

oštećenje

stanica

jetre)

vrućica,

osip,

povećani

bubrezi

ponekad

praćeni

bolnim

mokrenjem i boli u donjem dijelu leđa (ozbiljna upala bubrega).

Ostale nuspojave:

Često (javljaju se kod više od 1 na 100 osoba): dobroćudni polipi u ţelucu.

Manje često (javljaju se kod više od 1 na 1000 osoba): glavobolja, omaglica, proljev,

mučnina, povraćanje, nadutost i vjetrovi, zatvor, suhoća usta, bol i neugoda u trbuhu, osip na

koţi, egzantem, izbijanje koţnih promjena, svrbeţ, osjećaj slabosti, iscrpljenost i opće loše

osjećanje, poremećaji spavanja.

Uzimanje inhibitora protonske pumpe kao što je Acipan 20 mg, osobito tijekom vremenskog

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

kraljeţnice.

Obavijestite

svog

liječnika

bolujete

osteoporoze

uzimate

kortikosteroide (koji mogu povećati rizik od osteoporoze).

Rijetko (javljaju se kod manje od 1 na 1000 osoba): poremećaj ili potpuni nestanak osjeta

okusa, poremećaji vida kao što je zamućen vid, koprivnjača, bol u zglobovima, bol u

mišićima, promjene u tjelesnoj teţini, povišena tjelesna temperatura, visoka vrućica, oticanje

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

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Vrlo rijetko (javljaju se kod manje od 1 na 10 000 osoba): dezorijentiranost.

Nepoznato (učestalost se ne moţe procijeniti iz dostupnih podataka): halucinacije, smetenost

(osobito u bolesnika koji su već imali te simptome), trnci (parestezije), grč u mišićima,

smanjene razine natrija u krvi, osip, moguće praćen boli u zglobovima.

Ako uzimate Acipan 20 mg dulje od tri mjeseca, moţe doći do smanjenja razine magnezija u

krvi.

Niske

razine

magnezija

mogu

očitovati

umor,

nevoljno

stezanje

mišića,

dezorijentiranost, konvulzije, omaglica, povećan broj otkucaja 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 moţe odlučiti da je potrebno

provoditi redovite krvne pretrage kako bi se nadzirala razina magnezija u krvi.

Nuspojave koje se otkrivaju krvnim pretragama:

Manje često (javljaju se kod više od 1 na 1000 osoba): povišenje jetrenih enzima

Rijetko (javljaju se kod manje od 1 na 1000 osoba): povišenje bilirubina, povišenje razina

masnoća u krvi, naglo smanjenje broja granulocita - vrste bijelih krvnih stanica (povezano s

visokom vrućicom).

Vrlo rijetko (javljaju se kod manje od 1 od 10 000 osoba): smanjenje broja krvnih pločica,

što moţe izazvati neuobičajena krvarenja i stvaranje modrica; smanjenje broja bijelih krvnih

stanica što moţe dovesti do učestalih infekcija, istovremeno abnormalno smanjenje broja

crvenih (eritrocita) i bijelih (leukocita) krvnih stanica, te krvnih pločica (trombocita).

Prijavljivanje nuspojava

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

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

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

5. Kako čuvati Acipan 20 mg?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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

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

6. Sadržaj pakiranja i druge informacije

Što Acipan 20 mg sadrži?

Djelatna tvar Acipan 20 mg tableta je pantoprazol.

1 ţelučanootporna tableta sadrţava 20 mg pantoprazola u obliku pantoprazolnatrij seskvihidrata.

Pomoćne tvari:

Jezgra: kalcijev stearat; celuloza, mikrokristalična; krospovidon; hidroksipropilceluloza, vrsta EXF;

natrijev karbonat, bezvodni; silicijev dioksid, koloidni, bezvodni.

Ovojnica: hipromeloza; ţeljezov oksid, ţuti (E172); makrogol 400; metakrilna kiselina /etilakrilat

kopolimer (1:1); polisorbat 80; aluminijev lak, Ponceau 4R (E124); aluminijev lak, kinolon ţuti

(E104); natrijev laurilsulfat; titanijev dioksid (E171); trietilcitrat.

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Kako Acipan 20 mg izgleda i sadržaj pakiranja?

Ţuta, ovalna, ţelučanootporna tableta.

28 (4x7) tableta u blisteru (Al/OPA/Al/PVC), u kutiji

28 (2x14) tableta u blisteru (Al/OPA/Al/PVC), u kutiji

56 (8x7) tableta u blisteru (Al/OPA/Al/PVC), u kutiji

56 (4x14) tableta u blisteru (Al/OPA/Al/PVC), u kutiji

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

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

Proizvođač

Lek farmacevtska druţba d.d., Verovškova 57, Ljubljana, Slovenija

Lek farmacevtska druţba d.d., Trimlini 2D, Lendava, Slovenija

Lek S.A., Domaniewska str. 50 C, 02-672 Varšava, Poljska

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

Sandoz S.R.L., Livezeni Street 7A, Targu Mures, Rumunjska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u prosincu 2017.

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Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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