Ares 10 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Ares 10 mg želučanootporne tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • želučanootporna tableta
  • Sastav:
  • Urbroj: svaka želučanootporna tableta sadrži 10 mg rabeprazolnatrija
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Lek Pharmaceuticals d.d., Ljubljana, Slovenija; Lek farmacevtska družba d.d., Lendava, Slovenija; Salutas Pharma GmbH, Barlebe

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ares 10 mg želučanootporne tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 14 tableta u blisteru, u kutiji [HR-H-894184224-01]; 28 tableta u blisteru, u kutiji [HR-H-894184224-02] Urbroj: 381-12-01/70-17-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-894184224
  • Datum autorizacije:
  • 17-10-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Ares 10 mg ţelučanootporne tablete

Ares 20 mg ţelučanootporne tablete

rabeprazolnatrij

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 Ares i za što se koristi?

2. Što morate znati prije nego počnete uzimati Ares?

3. Kako uzimati Ares?

4. Moguće nuspojave

5. Kako čuvati Ares?

6. Sadrţaj pakiranja i druge informacije

1. Što je Ares i za što se koristi?

Ares tablete sadrţe djelatnu tvar rabeprazolnatrij. Rabeprazol pripada skupini lijekova koji se

nazivaju «inhibitori protonske pumpe». Ovi lijekovi smanjuju stvaranje kiseline koju proizvodi Vaš

ţeludac.

Ares se koristi za liječenje sljedećih stanja u odraslih:

čira na dvanaesniku (duodenalni ulkus)

čira na ţelucu (benigni gastrični ulkus)

ublaţavanje simptoma ţgaravice uzrokovane erozivnom ili ulcerativnom gastroezofagealnom

refluksnom bolešću (GERB) koja se još zove refluksni ezofagitis

dugotrajno liječenje gastroezofagealne refluksne bolesti (GERB) za sprječavanje njenog

ponovnog pojavljivanja

ublaţavanje simptoma umjerene do vrlo teške gastroezofagealne refluksne bolesti (simptomatska

GERB) kao što su ţgaravica ili vraćanje kiselog ţelučanog sadrţaja u jednjak

prekomjerno lučenje ţelučane kiseline (Zollinger-Ellisonov sindrom)

liječenje infekcija uzrokovanih bakterijom Helicobacter pylori (H pylori), u kombinaciji s

antibiotikom.

2. Što morate znati prije nego počnete uzimati Ares?

Nemojte uzimati Ares:

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

ako ste trudni ili ako dojite.

Nemojte uzimati Ares ako se bilo što od gore navedenog odnosi na Vas. Ako niste sigurni, obratite se

Vašem liječniku ili ljekarniku prije nego počnete uzimati Ares.

H A L M E D

17 - 10 - 2017

O D O B R E N O

Pogledajte dio „Trudnoća, dojenje i plodnosti.“

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Ares.

Prije nego što uzmete ove tablete recite Vašem liječniku ako ste alergični na druge inhibitore

protonske pumpe ili „supstituirane benzimidazole.“

Problemi s krvi i jetrom zamijećeni su u nekih bolesnika, ali obično se stanje popravljalo

kada se rabeprazol prestao primjenjivati.

Prije početka liječenja ovim lijekom treba isključiti mogućnost tumora jednjaka ili ţeluca.

Ako imate ili ste imali poteškoće s jetrom, trebate to reći Vašem liječniku. Vaš će liječnik,

moţda češće provjeravati funkciju Vaše jetre.

Uzimanje atazanavira (lijeka za liječenje HIV-a) s ovim tabletama se ne preporučuje; vidjeti

dio 2. Drugi lijekovi i Ares.

Ako ste na dugotrajnom liječenju (dulje od 1 godine) trebate redovito posjećivati Vašeg

liječnika.

Ako imate smanjene zalihe ili faktore rizika za smanjenje vitamina B12 i na dugotrajnoj ste

terapiji

rabeprazolnatrijem.

drugi

inhibitori

sekrecije

ţelučane

kiseline,

rabeprazolnatrij moţe dovesti do smanjenja apsorpcije vitamina B12.

Ako ste ikad imali koţnu reakciju nakon terapije s lijekom sličnim Ares tabletama koji

smanjuje ţelučanu kiselinu.

Ako morate napraviti odreĎenu krvnu pretragu (kromogranin A).

Ako niste sigurni da li se nešto od gore navedenog odnosi na Vas obratite se svom liječniku ili

ljekarniku prije nego počnete uzimati Ares.

Djeca

Ares se ne smije primjenjivati u djece.

Ako imate teški (vodenast ili krvavi) proljev sa simptomima kao što su vrućica, bolovi u trbuhu ili

osjetljivost trbuha, prestanite uzimati Ares i odmah se obratite Vašem liječniku.

Uzimanje inhibitora protonske pumpe kao što je Ares, 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 Ares tabletama. Sjetite se spomenuti i bilo

koje druge štetne učinke poput boli u zglobovima.

Drugi lijekovi i Ares

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

koje druge lijekove.

Prije nego što uzmete ove tablete recite Vašem liječniku ako uzimate neke od sljedećih lijekova:

ketokonazol ili itrakonazol (lijekovi za liječenje gljivičnih infekcija). Ares moţe smanjiti

količinu ove vrste lijeka u Vašoj krvi. Vaš liječnik će moţda trebati prilagoditi Vašu dozu.

atazanavir (lijek za liječenje HIV-a). Ares moţe smanjiti količinu ove vrste lijeka u Vašoj krvi i

zbog toga se ne smiju koristiti zajedno.

metotreksat (lijek za kemoterapiju koji se koristi u visokim dozama za liječenje raka). Ako

uzimate

visoke

doze

metotreksata,

Vaš liječnik

moţe

privremeno

prekinuti

liječenje

Ares

tabletama.

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17 - 10 - 2017

O D O B R E N O

Ako niste sigurni da li se nešto od gore navedenog odnosi na Vas obratite se Vašem liječniku ili

ljekarniku prije nego počnete uzimati Ares.

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.

Nemojte uzimati Ares ako ste trudni ili mislite da biste mogli biti trudni.

Nemojte uzimati Ares ako dojite ili planirate dojiti.

Pitajte Vašeg liječnika ili ljekarnika za savjet prije nego što uzmete bilo koji lijek za vrijeme trudnoće

ili dojenja.

Upravljanje vozilima i strojevima

Moţete se osjećati pospano za vrijeme liječenja rabeprazolom. Ako se to dogodi, nemojte voziti ili

raditi sa strojevima.

3. Kako uzimati Ares?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite s Vašim liječnikom

ili ljekarnikom ako niste sigurni.

Ako uzimate tablete Ares jedanput na dan, uzmite ih ujutro prije obroka.

Tablete progutajte cijele s vodom. Nemojte ih ţvakati ili drobiti.

Vaš liječnik će Vam reći koliko tableta trebate uzimati i koliko dugo. To će ovisiti o stanju Vaše

bolesti.

Ukoliko ćete ovaj lijek uzimati kroz duţi period, Vaš liječnik će Vas za vrijeme liječenja kontrolirati.

Čir dvanaesnika (duodenalni ulkus)

Uobičajena doza je 20 mg, jedanput na dan ujutro, tijekom 4 tjedna. Vaš liječnik moţe odlučiti o

produţetku liječenja za još 4 tjedna.

Čir želuca (gastrični ulkus)

Uobičajena doza je 20 mg, jedanput na dan ujutro, tijekom 6 tjedana. Vaš liječnik moţe odlučiti o

produţetku liječenja za još 6 tjedana.

Erozivna ili ulcerativna gastroezofagealna refluksna bolest (GERB)

Uobičajena doza je 20 mg, jedanput na dan, tijekom 4 – 8 tjedana.

Dugotrajno liječenje gastroezofagealne refluksne bolesti (GERB-a)

Uobičajena doza odrţavanja je 10 mg ili 20 mg, jedanput na dan. Ako ste na dugotrajnom liječenju

trebate redovito posjećivati Vašeg liječnika kako bi provjeravao doziranje tableta i simptome bolesti.

Ublažavanje simptoma umjerene do vrlo teške gastroezofagealne refluksne bolesti (GERB-a)

Uobičajena doza je 10 mg, jedanput na dan, tijekom 4 tjedna.

Ako se simptomi bolesti ne povuku unutar 4 tjedna liječenja, zatraţite savjet Vašeg liječnika. Nakon

početnih

4 tjedna liječenja,

ponovo

vrate

simptomi

bolesti,

liječnik

moţe

savjetovati da «po potrebi» uzmete jednu tabletu od 10 mg, kako bi kontrolirali simptome.

Prekomjerno lučenje želučane kiseline (Zollinger-Ellisonov sindrom)

H A L M E D

17 - 10 - 2017

O D O B R E N O

Uobičajena početna doza je 60 mg, jedanput na dan. Ovisno o tome kako reagirate na liječenje,

liječnik moţe prilagoditi dozu lijeka. Mogu se dati doze do 60 mg, dvaput na dan.

Liječnik će Vam reći koliko tableta trebate uzeti, kada ćete ih uzeti i koliko dugo ćete ih uzimati.

Liječenje infekcija uzrokovane bakterijom H. pylori, u kombinaciji s antibiotikom

Uobičajena doza je 20 mg, dvaput na dan u kombinaciji s 2 antibiotika. Preporučena je kombinacija:

Ares 20 mg + klaritromicin 500 mg + amoksicilin 1 g, uzeti zajedno dvaput na dan, tijekom 7 dana.

Bolesnici s oštećenjem funkcije bubrega ili jetre

Nije potrebno prilagoĎavati dozu. Liječnik će Vas drţati pod nadzorom na početku liječenja i za

vrijeme liječenja.

Primjena u djece

Tablete Ares nemojte davati djeci.

Ako uzmete više tableta Ares nego što ste trebali

Ako ste slučajno uzeli više tableta od propisane doze, obratite se Vašem liječniku ili se uputite na

odjel hitne pomoći najbliţe bolnice. Ponesite sa sobom ovu Uputu, kutiju i ostatak tableta kako bi

Vaš liječnik ili liječnik u bolnici znali koji ste lijek uzeli.

Ako ste zaboravili uzeti Ares

Vaţno je da svoj lijek uzimate svaki dan, jer je redovito liječenje učinkovitije. Ipak, ako ste

zaboravili uzeti jednu ili više doza, lijek uzmite čim se sjetite i nastavite ga uzimati prema

uobičajenom rasporedu. Ako ste zaboravili uzeti lijek kroz više od 5 dana, posavjetujte se s Vašim

liječnikom prije nego ponovno počnete uzimati lijek. Nemojte uzeti dvostruku dozu kako biste

nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Ares

Olakšanje simptoma obično nastupa prije nego ulkus potpuno zacijeli. Vaţno je da ne prestanete

uzimati tablete prije nego o tome obavijestite svog liječnika.

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.

Nuspojave su obično blage i prolazne i ne zahtijevaju prestanak uzimanja ovog lijeka.

Ozbiljne nuspojave

Odmah se javite svom liječniku ako primijetite neku od sljedećih ozbiljnih nuspojava (mogu biti

alergijske reakcije) jer ćete moţda trebati hitno medicinsko zbrinjavanje:

Rijetke ozbiljne nuspojave (mogu se javiti u 1 na 1000 osoba)

Alergijske reakcije – simptomi mogu uključivati: oticanje lica, usana, jezika i grla što moţe

uzrokovati teškoće u disanju, govoru ili gutanju, nagli pad krvnog tlaka, bljedilo, nesvjesticu ili

kolaps

Česte infekcije, poput upale grla ili visoke temperature (groznice), ili čireva u ustima ili grlu

Lako krvarenje ili nastajanje modrica

Vrlo rijetke ozbiljne nuspojave (mogu se javiti u 1 na 10 000 osoba)

stvaranje mjehura na koţi i/ili sluznici usana, očiju, usta, nosa ili spolovila (Stevens-Johnsonov

sindrom) ili ljuštenje koţe (toksična epidermalna nekroliza).

H A L M E D

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O D O B R E N O

Ostale moguće nuspojave

Česte nuspojave (mogu se javiti u 1 na 10 osoba) su:

glavobolja, omaglica

nemogućnost spavanja

kašalj, grlobolja, začepljenost i iscjedak iz nosa

proljev, povraćanje, mučnina, bol u trbuhu, zatvor, vjetrovi (flatulencija)

neodreĎena bol, bol u leĎima

infekcije

slabost, bolest slična gripi

dobroćudni polipi u ţelucu

Manje česte (mogu se javiti u 1 na 100 osoba) su:

nervoza,omamljenost

produktivan kašalj, bol u prsima i vrućica

osjećaj pritiska ili bola u području obraza i čela

probavne smetnje, suha usta, podrigivanje

osip, crvenilo koţe

bol u mišićima, grčevi u nogama i bol u zglobovima

infekcije mokraćnog sustava

bol u prsima, zimica, vrućica

povišene vrijednosti jetrenih enzima

prijelomi kuka, zgloba i kraljeţnice

Rijetke (mogu se javiti u 1 na 1000 osoba) su:

promjene krvne slike koje mogu dovesti do čestih infekcija, krvarenja ili pojave modrica češće

od uobičajenog ili do umora

gubitak teka (anoreksija)

smetnje vida

upala ţeluca (gastritis) što moţe uzrokovati bol u trbuhu i mučninu

upala usne šupljine

promjene okusa

poremećaj jetre (hepatitis) što moţe uzrokovati ţutu boju koţe i bjeloočnice (ţutica)

zatajenje jetre što moţe dovesti do oštećenja mozga u bolesnika koji su prije imali bolest jetre

svrbeţ i stvaranje mjehura na koţi: obično nestaje nakon prekida liječenja

znojenje

problemi s bubrezima što moţe uzrokovati povećano ili smanjeno mokrenje

povećanje tjelesne teţine

depresija

preosjetljivost, uključujući alergijske reakcije.

Nepoznata učestalost (učestalost se ne moţe procijeniti iz dostupnih podataka)

sniţena razina natrija u krvi

sniţena razina magnezija u krvi*

smetenost

povećanje grudi u muškaraca

oticanje zglobova, stopala ili prstiju.

osip, moguće praćen boli u zglobovima.

*Ako uzimate Ares dulje od tri mjeseca moguće je da se razina magnezija u Vašoj krvi snizi. Niske

razine magnezija mogu biti vidljive kao umor, nesvjesno grčenje mišića, dezorijentiranost, konvulzije,

omaglica, povećani

broj otkucaja srca. Ako osjetite bilo koji od ovih simptoma, odmah obavijestite

svog liječnika. Niska razina magnezija moţe dovesti do smanjenja razine kalija ili kalcija u krvi. Vaš

liječnik moţe odlučiti o potrebi obavljanja redovitih krvnih pretraga radi praćenja razine magnezija u

Vašoj krvi.

H A L M E D

17 - 10 - 2017

O D O B R E N O

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.

Prijavljivanjem nuspojava moţete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Ares?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25 °C, u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrebljavati nakon isteka roka valjanosti, navedenog na kutiji.

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

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 zaštiti okoliša.

6. Sadržaj pakiranja i druge informacije

Što Ares sadrži?

Djelatna tvar je rabeprazolnatrij.

Ares 10 mg

Jedna ţelučanootporna tableta sadrţi 10 mg rabeprazolnatrija.

Ares 20 mg

Jedna ţelučanootporna tableta sadrţi 20 mg rabeprazolnatrija.

Pomoćne tvari

Jezgra

tablete:

kalcijev

hidroksid,

manitol,

nisko

supstituirana

hidroksipropilceluloza,

natrijev

stearilfumarat

Ovojnica tablete: hipromeloza, talk

Želučanootporna ovojnica tablete: hipromelozaftalat, dibutilsebakat, ţuti ţeljezov oksid (E172),

crveni ţeljezov oksid (E172), titanijev dioksid (E171).

Kako Ares izgleda i sadržaj pakiranja?

Ţelučanootporna tableta.

Ares 10 mg

ruţičaste, okrugle, bikonveksne filmom obloţene tablete, promjera od 5.6- 5.8 mm, debljine 2.8- 3.8

Ares 20 mg

ţute, okrugle, bikonveksne filmom obloţene tablete, promjera 7.1- 7.3 mm, debljine 4.2- 4.8 mm

Ares 10 mg

14 ţelučanootpornih tableta u (Al/Al) blisteru sa sredstvom za sušenje

28 ţelučanootpornih tableta u (Al/Al) blisteru sa sredstvom za sušenje

Ares 20 mg

14 ţelučanootpornih tableta u (Al/Al) blisteru sa sredstvom za sušenje

28 ţelučanootpornih tableta u (Al/Al) blisteru sa sredstvom za sušenje

H A L M E D

17 - 10 - 2017

O D O B R E N O

U prometu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o., Maksimirska 120, 10000 Zagreb

ProizvoĎač

Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, Slovenija

Salutas Pharma GmbH, Otto-von-Guericke-Allee1, Barleben, Njemačka

Salutas Pharma GmbH, Dieselstrasse 5, Gerlingen, Njemačka

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

Lek d.d., Trimlini 2D, 9220 Lendava, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u listopadu 2017.

H A L M E D

17 - 10 - 2017

O D O B R E N O

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

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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

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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

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

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