Artas 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Artas 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: 1 filmom obložena tableta sadrži 10 mg atorvastatina u obliku atorvastatinkalcija
  • 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:
  • Artas 10 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-309700209-01]; 56 tableta u blisteru, u kutiji [HR-H-309700209-02] Urbroj: 381-12-01/30-16-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-309700209
  • Datum autorizacije:
  • 23-03-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Artas 10 mg filmom obložene tablete

Artas 20 mg filmom obložene tablete

Artas 40 mg filmom obložene tablete

atorvastatin

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

važne podatke.

- Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

- Ako imate dodatnih pitanja, obratite se Vašem 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 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:

Što je Artas i za što se koristi?

Što morate znati prije nego počnete uzimati Artas?

Kako uzimati Artas?

Moguće nuspojave

Kako čuvati Artas?

Sadržaj pakiranja i druge informacije

1. Što je Artas i za što se koristi?

Artas pripada skupini lijekova pod nazivom statini, a to su lijekovi za regulaciju masnoća

(lipida) u krvi.

Artas se koristi za snižavanje lipida (kolesterola i triglicerida) u krvi u slučajevima kada

prehrana sa smanjenim unosom masnoća i promjena načina života nisu dale očekivani

rezultat. Ukoliko ste osoba s povećanim rizikom od srčanih oboljenja, Artas se takoĎer može

koristiti u svrhu snižavanja toga rizika, čak i u slučaju da su Vam razine kolesterola u

granicama normale.

Tijekom liječenja morate se i dalje pridržavati standardne dijete za snižavanje kolesterola.

2. Što morate znati prije nego počnete uzimati Artas?

Nemojte uzimati Artas:

ako ste alergični na atorvastatin, bilo koje slične lijekove za snižavanje lipida u krvi ili

neki drugi sastojak ovog lijeka (naveden u dijelu 6.),

ukoliko imate ili ste ikada imali neko oboljenje jetre,

ukoliko ste imali neobjašnjiva odstupanja od normale u testovima jetrenih funkcija,

ukoliko

žena

koja

može

zatrudnjeti,

primjenjujete

pouzdane

metode

sprječavanja trudnoće (kontracepcijske mjere),

ukoliko ste trudni ili pokušavate zatrudnjeti,

ukoliko dojite.

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Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Artas.

Iz sljedećih razloga Artas možda neće biti odgovarajući lijek za Vas:

ukoliko ste pretrpjeli moždani udar s krvarenjem u mozgu, ili u mozgu imate male,

tekućinom ispunjene prostore zaostale od prethodnih moždanih udara,

ukoliko imate probleme s bubrezima,

ukoliko bolujete od smanjene aktivnosti štitne žlijezde (hipotireoze),

ukoliko ste imali ili imate neobjašnjive i ponavljajuće bolove u mišićima, odnosno ako ste

Vi ili netko od Vaših bliskih srodnika do sada imali problema s mišićima,

ukoliko ste ranije uzimali neki drugi lijek za snižavanje lipida u krvi (drugi lijekovi iz

skupine ˝statina˝ ili ˝fibrata˝) te pritom imali probleme s mišićima,

ukoliko redovito konzumirate veće količine alkohola,

ukoliko ste do sada imali probleme s jetrom,

stariji ste bolesnik (stariji od 70 godina).

Prije uzimanja lijeka Artas posavjetujte se s Vašim liječnikom ili ljekarnikom:

- ukoliko bolujete od teških problema s disanjem (teškog respiratornog zatajenja).

Ako se bilo što od gore navedenoga odnosi na Vas, Vaš će liječnik morati napraviti krvnu

pretragu prije, a možda i tijekom Vaše terapije lijekom Artas kako bi predvidio Vaš rizik od

mogućih mišićnih nuspojava. Poznato je da se rizik od mogućih mišićnih nuspojava, npr.

rabdomiolize, povećava prilikom istodobnog uzimanja odreĎenih lijekova (pogledajte dio 2

''Drugi lijekovi i Artas''.)

TakoĎer obavijestite Vašeg liječnika ili ljekarnika ako imate konstantnu mišićnu slabost.

Možda će biti potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.

Tijekom primjene ovog lijeka Vaš liječnik će Vas pomno nadzirati ako imate šećernu bolest

ili ste pod rizikom od razvoja šećerne bolesti. Postoji veća vjerojatnost za rizik od razvoja

šećerne bolesti ako imate visoke razine šećera i masnoća u krvi, prekomjernu tjelesnu težinu i

visoki krvni tlak.

Djeca i adolescenti

Artas se smije primjenjivati kod djece u dobi od 10 godina i starije samo ako je to odredio

liječnik s iskustvom liječenja poremećaja masnoća (lipida) kod djece.

Lijek se ne smije primjenjivati kod djece mlaĎe od 10 godina jer su podaci o primjeni u toj

dobnoj skupini ograničeni. Nije utvrĎena sigurnost primjene lijeka na razvoj djece.

Drugi lijekovi i Artas

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

bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.

Postoje odreĎeni lijekovi koji mogu promijeniti učinak lijeka Artas ili se njihov učinak može

promijeniti uzimanjem lijeka Artas. Ovakva vrsta meĎudjelovanja (interakcije) može dovesti

do smanjenog učinka jednog ili obaju lijekova. U suprotnom slučaju, može doći i do

povećanja rizika ili težine nuspojava, uključujući i ozbiljno stanje razgradnje mišića pod

nazivom rabdomioliza, opisano u dijelu 4:

lijekovi koji mijenjaju rad Vašeg imunološkog sustava, npr. ciklosporin;

odreĎeni lijekovi za liječenje infekcija, poput antibiotika ili lijekova protiv gljivičnih

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infekcija,

npr.

eritromicin,

klaritromicin,

telitromicin,

ketokonazol,

vorikonazol,

flukonazol, posakonazol, itrakonazol, rifampicin, fusidatna kiselina;

drugi lijekovi za regulaciju razine masnoća (lipida) u krvi, npr. gemfibrozil, drugi fibrati,

kolestipol;

lijekovi koji se koriste za liječenje angine pektoris ili povišenog krvnog tlaka, poput nekih

blokatora kalcijevih kanala, npr. amlodipin, diltiazem;

lijekovi za regulaciju srčanog ritma, npr. digoksin, verapamil, amiodaron;

lijekovi koji se koriste u liječenju infekcije HIV-om, npr. ritonavir, lopinavir, atazanavir,

indinavir,

darunavir,

sakvinavir,

fosamprenavir,

kombinacija

tipranavir/ritonavir,

delavirdin, efavirenz itd.;

odreĎeni lijekovi koji se koriste za liječenje hepatitisa C, npr. telaprevir.

drugi lijekovi za koje je poznato da stupaju u interakciju s lijekom Artas, uključujući:

ezetimib - lijek koji se koristi za snižavanje kolesterola

varfarin - lijek koji sprječava stvaranje krvnih ugrušaka,

oralne kontraceptive – lijekovi za sprječavanje začeća,

stiripentol - lijek protiv epileptičnih napadaja,

cimetidin - lijek koji se koristi u liječenju žgaravice i čira na želucu,

fenazon - lijek protiv bolova,

kolhicin - lijek koji se koristi za liječenje gihta,

lijekove za smanjivanje želučane kiseline odnosno lijekovi protiv probavnih tegoba

koje sadrže aluminij ili magnezij,

boceprevir - lijek koji se koristi za liječenje bolesti jetre kao što je hepatitis C

lijekovi koji se mogu dobiti bez recepta poput pripravaka s gospinom travom.

Artas s hranom, pićem i alkoholom

Pogledajte dio 3 za uputu o uzimanju lijeka Artas. Molimo obratite pozornost na sljedeće:

Sok od grejpa

Nemojte uzimati više od jedne do dvije male čaše soka od grejpa dnevno, budući da veće

količine soka mogu izmijeniti učinak Artas filmom obloženih tableta.

Alkohol

Izbjegavajte uzimanje alkohola u većim količinama tijekom liječenja lijekom Artas. Za

detalje pogledajte dio 2 ''Upozorenja i mjere opreza''.

Trudnoća, dojenje i plodnost

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.

Ne smijete uzimati Artas ukoliko ste trudni ili pokušavate zatrudnjeti.

Ne smijete uzimati Artas ukoliko ste žena u dobi u kojoj možete zatrudnjeti, a ne

primjenjujete pouzdane kontracepcijske mjere.

Ne smijete uzimati Artas ukoliko dojite.

Sigurnost primjene lijeka Artas tijekom trudnoće i dojenja za sada nije dokazana.

Upravljanje vozilima i strojevima

Artas ima zanemariv utjecaj na Vašu sposobnost upravljanja vozilima i strojevima. MeĎutim,

ukoliko osjetite da ovaj lijek utječe na Vašu sposobnost upravljanja vozilima i strojevima,

nemojte voziti odnosno nemojte koristiti alate ili strojeve.

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3. Kako uzimati Artas?

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Prije nego što započnete s liječenjem, Vaš će Vam liječnik odrediti dijetu za snižavanje

kolesterola, s kojom morate nastaviti i tijekom uzimanja lijeka Artas.

Primjena u odraslih osoba

Uobičajena početna doza lijeka Artas je 10 mg jednom na dan za odrasle osobe.

Ukoliko je potrebno, liječnik može povisivati dozu sve dok se ne postigne željeni terapijski

učinak. Liječnik će dozu prilagoĎavati u razmacima od 4 tjedna ili dulje.

Maksimalna doza lijeka Artas je 80 mg jednom na dan za odrasle osobe.

Primjena u djece i adolescenata

Uobičajena početna doza lijeka Artas iznosi 10 mg jednom na dan za djecu u dobi od 10

godina i stariju.

Maksimalna doza ovog lijeka za djecu je 20 mg jednom na dan.

Ovaj lijek nije namijenjen za liječenje bolesnika mlaĎih od 10 godina.

Način primjene

Artas filmom obložene tablete potrebno je progutati cijele, s malo tekućine.

Lijek se može uzimati u bilo koje doba dana, neovisno o obroku. Ipak, preporuča se da Artas

filmom obložene tablete uzimate svakog dana u isto vrijeme.

Trajanje liječenja lijekom Artas određuje Vaš liječnik.

Obratite se Vašem liječniku ukoliko imate dojam da je učinak lijeka Artas prejak ili preslab.

Ako uzmete više Artasa nego što ste trebali

Ako slučajno uzmete previše Artas filmom obloženih tableta (više od Vaše uobičajene dnevne

doze), odmah za savjet kontaktirajte Vašeg liječnika ili najbližu bolnicu.

Ako ste zaboravili uzeti Artas

Ako ste zaboravili uzeti jednu dozu, sljedeću dozu uzmite prema uobičajenom rasporedu.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Artas

Ako imate dodatnih pitanja o uporabi ovoga lijeka, ili ako želite prekinuti liječenje, obratite se

Vašem liječniku ili ljekarniku.

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 može uzrokovati nuspojave iako se one neće pojaviti kod

svakoga.

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Ukoliko dođe do pojave bilo koje od niže navedenih ozbiljnih nuspojava, prestanite s

uzimanjem tableta i odmah obavijestite Vašeg liječnika ili se uputite u najbližu hitnu

službu.

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

ozbiljna alergijska reakcija s oticanjem lica, jezika i grla koja može prouzročiti teške

dišne tegobe (tzv. angioedem).

ozbiljna bolest s jakim ljuštenjem i oticanjem kože, stvaranjem plikova na koži,

ustima, očima i spolnim organima, uz povišenu tjelesnu temperaturu.

kožni osip s ružičasto-crvenim mrljama, posebice na dlanovima i tabanima, uz

moguću pojavu plikova.

mišićna slabost, osjetljivost ili bol; posebice ukoliko pritom osjećate i slabost ili imate

visoku temperaturu, moguće je da je došlo do neuobičajenog oštećenja mišića.

Neuobičajeno oštećenje mišića ne mora uvijek proći, čak i ako ste prestali s

uzimanjem atorvastatina te može biti opasno po život i dovesti do problema s

bubrezima.

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

ukoliko se pojavi neočekivano ili neuobičajeno krvarenje ili se pojave modrice, to

može ukazivati na ozbiljno oštećenje jetre. U tom se slučaju što je prije moguće

posavjetujte s liječnikom.

ozbiljne alergijske reakcije - simptomi mogu uključivati naglu pojavu piskutavog

disanja praćenog bolovima ili osjećajem stezanja u prsištu, oticanje očnih kapaka, lica,

usana, usta, jezika ili grla, otežano disanje, kolaps (anafilaksija).

Druge moguće nuspojave lijeka Artas:

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

upala nosnih putova, grlobolja, krvarenje iz nosa,

alergijske reakcije,

porast vrijednosti šećera u krvi (ukoliko imate dijabetes, nastavite pozorno pratiti

razinu šećera u Vašoj krvi),

porast vrijednosti enzima kreatin kinaze u krvi,

glavobolja,

mučnina, zatvor, vjetrovi, probavne tegobe, proljev,

bolovi u zglobovima i mišićima, bolovi u leĎima, bol u ekstremitetima, grčevi u

mišićima, oticanje zglobova,

promjene jetrenih funkcija (na što ukazuju pretrage krvne slike).

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

gubitak apetita (anoreksija), porast tjelesne težine,

pad vrijednosti šećera u krvi (ukoliko imate dijabetes, nastavite pozorno pratiti razinu

šećera u Vašoj krvi),

noćne more, nesanica,

omaglica, obamrlost ili trnci u prstima ruku i nogu, smanjen osjet boli ili dodira,

promjene osjeta okusa, gubitak pamćenja,

zamućen vid,

zvonjenje u ušima i/ili glavi,

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povraćanje, podrigivanje, bol u gornjem i donjem dijelu trbuha, upala gušterače

povezana s bolovima u želucu (pankreatitis),

upala jetre (hepatitis),

osip, kožni osip i svrbež, koprivnjača, ispadanje kose,

bolovi u vratu, zamor mišića,

umor, osjećaj malaksalosti, slabost, bolovi u prsištu, oticanje, posebice gležnjeva

(edemi), povišena tjelesna temperatura,

prisutnost bijelih krvnih stanica (leukociti) u urinu.

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

smetnje vida,

neočekivana krvarenja ili pojava modrica, što ukazuje na smanjen broj krvnih pločica

(trombocita) u krvi,

žutilo kože i bjeloočnica (kolestaza),

oštećenje mišića, upala mišića, ozljede tetiva,

periferna neuropatija (oštećenje perifernih živaca).

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

gubitak sluha.

povećanje dojki u muškaraca (ginekomastija).

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

mišićna slabost koja je konstantna.

Dodatne nuspojave u djece

Na temelju dostupnih podataka, očekuje se da će učestalost, vrsta i težina nuspojava u djece i

adolescenata biti ista kao i kod odraslih.

Moguće nuspojave zabilježene pri uporabi nekih statina (lijekova iste vrste):

seksualne tegobe,

depresija,

tegobe s disanjem, uključujući stalni kašalj i/ili zaduhu, ili povišena tjelesna

temperatura

šećerna bolest. Razvoj šećerne bolesti je vjerojatniji ako imate visoke razine šećera i

masnoća u krvi, prekomjernu tjelesnu težinu ili visok krvni tlak. Liječnik će Vas

nadzirati dok uzimate ovaj lijek.

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 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 Artas?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Lijek ne zahtijeva posebne uvjeta čuvanja.

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

oznake EXP.

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

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

okoliša.

6. Sadržaj pakiranja i druge informacije

Što Artas sadrži?

Jedna Artas filmom obložena tableta sadrži 10 mg, 20 mg odnosno 40 mg atorvastatina u

obliku atorvastatinkalcija.

Drugi sastojci (pomoćne tvari) su: mikrokristalična celuloza, bezvodni natrijev karbonat,

maltoza, umrežena karmeloza natrij, magnezijev stearat, hipermeloza, hidroksipropilceluloza,

trietilcitrat, polisorbat 80, titanijev dioksid (171).

Kako Artas izgleda i sadržaj pakiranja?

Artas 10 mg filmom obložene tablete

Filmom obložena bijela tableta, eliptičnog oblika, bikonveksna, glatka, dimenzija 9.7 mm x

5.2 mm.

28 filmom obloženih tableta u blister (Al/Al) pakiranju.

56 filmom obloženih tableta u blister (Al/Al) pakiranju.

Artas 20 mg filmom obložene tablete

Filmom obložena bijela tableta, eliptičnog oblika, bikonveksna, glatka, dimenzija 12.5 mm x

6.6 mm.

28 filmom obloženih tableta u blister (Al/Al) pakiranju.

56 filmom obloženih tableta u blister (Al/Al) pakiranju.

Artas 40 mg filmom obložene tablete

Filmom obložena bijela tableta, eliptičnog oblika, bikonveksna, glatka, dimenzija 15.6 mm x

8.3 mm.

28 filmom obloženih tableta u blister (Al/Al) pakiranju.

56 filmom obloženih tableta u blister (Al/Al) pakiranju.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

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

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u lipnju 2017.

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18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety