Zulbex 10 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Zulbex 10 mg želučanootporne tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • želučanootporna tableta
  • Sastav:
  • Urbroj: svaka želučanootporna tableta sadrži 10 mg rabeprazolnatrija, što odgovara 9,42 mg rabeprazola
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 7 tableta u blisteru, u kutiji [HR-H-002213264-01]; 10 tableta u blisteru, u kutiji [HR-H-002213264-02]; 14 tableta u blisteru, u kutiji [HR-H-002213264-03]; 15 tableta u blisteru, u kutiji [HR-H-002213264-04]; 28 tableta u blisteru, u kutiji [HR-H-002213264-05]; 30 tableta u blisteru, u kutiji [HR-H-002213264-06]; 56 tableta u blisteru, u kutiji [HR-H-002213264-07]; 60 tableta u blisteru, u kutiji [HR-H-002213264-08]; 90 tableta u blisteru, u kutiji [HR-H-002213264-09]; 98 tableta u blisteru, u kutiji [HR-H-002213264-10]; 100 tableta u blisteru, u kutiji [HR-H-002213264-11] Urbroj: 381-12-01/30-17-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-002213264
  • Datum autorizacije:
  • 27-09-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Zulbex 10 mg želučanootporne tablete

Zulbex 20 mg želučanootporne tablete

rabeprazolnatrij

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

podatke.

Sačuvajte ovu uputu. Moţda 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. 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:

Što je Zulbex i za što se koristi?

Što morate znati prije nego počnete uzimati Zulbex?

Kako uzimati Zulbex?

Moguće nuspojave

Kako čuvati Zulbex?

Sadrţaj pakiranja i druge informacije

1.

Što je Zulbex i za što se koristi?

Zulbex tablete sadrţe djelatnu tvar rabeprazol. Pripada skupini lijekova poznatih pod nazivom

inhibitori protonske pumpe. Djeluju tako što smanjuju količinu kiseline koja se proizvodi u ţelucu.

Zulbex tablete se koriste za liječenje:

gastroezofagealne refluksne bolesti (GERB) koja moţe biti povezana sa ţgaravicom. U

gastroezofagealnoj refluksnoj bolesti se kiselina i hrana iz ţeluca vraćaju u jednjak.

čireva u ţelucu ili gornjem dijelu crijeva. Ako su ti čirevi zaraţeni bakterijom koja se zove

Helicobacter pylori (H. Pylori), dobit ćete i terapiju antibioticima. Uzimanje ovog lijeka i antibiotika

zajedno dovodi do prestanka infekcije i zacijeljivanja čira. TakoĎer, spriječava ponovnu pojavu

infekcije i čira.

Zollinger-Ellisonovog sindroma, stanja u kojem ţeludac proizvodi previše kiseline.

2.

Što morate znati prije nego počnete uzimati Zulbex?

Nemojte uzimati Zulbex

ako ste alergični na rabeprazolnatrij ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),

ako ste trudni ili mislite da ste trudni,

ako dojite (vidjeti dio Trudnoća i dojenje).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Zulbex:

ako ste alergični na druge inhibitore protonske pumpe ili ostale lijekove iz iste skupine lijekova

koja se zove ''supstituirani benzimidazoli''

ako imate tumor ţeluca

ako ste u prošlosti imali bolesti jetre

ako uzimate atazanavir (lijek kojim se liječi HIV)

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ako imate smanjene tjelesne zalihe ili faktore rizika za smanjenje vitamina B

te primate

rabeprazol kao dugotrajnu terapiju. Kao i sve tvari koje smanjuju kiselinu, rabeprazol moţe

dovesti do smanjene apsorpcije vitamina B

ako ste ikad imali koţnu reakciju nakon terapije s lijekom sličnim Zulbexu koji smanjuje

ţelučanu kiselinu

ako morate napraviti odreĎenu krvnu pretragu (kromogranin A)

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

prije moguće jer ćete moţda morati prekinuti liječenje Zulbexom. Sjetite se spomenuti i bilo koje

druge štetne učinke poput boli u zglobovima.

Ako dobijete teški (vodeni ili krvavi) proljev sa simptomima kao što su vrućica, bol u trbuhu ili

osjetljivost na dodir, prestanite uzimati ovaj lijek i odmah posjetite liječnika.

Uzimanje inhibitora protonske pumpe kao što je Zulbex, osobito tijekom vremenskog perioda duljeg

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

Vašeg liječnika ako bolujete od osteoporoze ili ako uzimate kortikosteroide (koji mogu povećati rizik

od osteoporoze).

U nekih bolesnika zamijećeni su problemi s jetrom i krvi, ali se njihovo stanje najčešće poboljša nakon

prestanka primjene ovog lijeka.

Djeca i adolescenti

Ovaj lijek nije namijenjen za primjenu u djece.

Drugi lijekovi i Zulbex

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

druge lijekove.

Obavijestite Vašeg liječnika ili ljekarnika:

ako uzimate ketokonazol (lijek za liječenje Cushingovog sindroma). Zulbex moţe smanjiti

količinu ove vrste lijeka u Vašoj krvi. Liječnik će Vam moţda trebati prilagoditi dozu.

ako uzimate itrakonazol (lijek za liječenje gljivičnih infekcija). Zulbex moţe smanjiti količinu

ove vrste lijeka u Vašoj krvi. Liječnik će Vam moţda trebati prilagoditi dozu.

ako uzimate atazanavir (lijek kojim se liječi HIV). Zulbex moţe smanjiti količinu ove vrste

lijeka u Vašoj krvi te se ne smiju uzimati zajedno.

ako uzimate metotreksat (lijek za kemoterapiju koji se koristi u visokim dozama za liječenje

raka) – ako uzimate visoke doze metotreksata, Vaš liječnik moţe privremeno prekinuti liječenje

Zulbexom.

Ako niste sigurni odnosi li se nešto od navedenog na Vas, obratite se Vašem liječniku ili ljekarniku

prije uzimanja ovog lijeka.

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 koristiti Zulbex ako ste trudni ili mislite da ste trudni.

Nemojte koristiti Zulbex ako dojite ili namjeravate dojiti.

Upravljanje vozilima i strojevima

Moţda ćete tijekom uzimanja ovog lijeka osjetiti pospanost. Ako se to dogodi, nemojte upravljati

vozilima ili raditi s alatima ili strojevima.

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3.

Kako uzimati Zulbex?

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

liječnikom ili ljekarnikom ako niste sigurni.

Tablete Zulbex se moraju progutati cijele s čašom vode.

Ne smiju se pregristi ili ţvakati.

Vaš liječnik će odrediti koliko tableta ćete uzimati i koliko dugo. To ovisi o Vašem stanju.

Ako uzimate lijek duţe vrijeme, Vaš liječnik će Vas redovito nadzirati.

Odrasli i starije osobe

Čir na želucu

Uobičajena doza ovog lijeka je jedna tableta od 20 mg jednom na dan kroz 6 tjedana. Tabletu uzmite ujutro

prije jela. Vaš liječnik moţe produljiti primjenu ovog lijeka na sljedećih 6 tjedana ako se Vaše stanje ne

poboljša.

Čir na dvanaesniku (početku tankog crijeva)

Uobičajena doza ovog lijeka je jedna tableta od 20 mg jednom na dan kroz 4 tjedna. Tabletu uzmite ujutro

prije jela. Vaš liječnik moţe produljiti primjenu ovog lijeka na sljedeća 4 tjedna ako se Vaše stanje ne

poboljša.

Gastroezofagealna refluksna bolest (GERB)

Erozivna ili ulcerativna GERB (vrlo teški simptomi)

Uobičajena doza ovog lijeka je jedna tableta od 20 mg jednom na dan kroz 4 do 8 tjedana. Tabletu uzmite

ujutro prije jela.

Održavanje GERB (dugotrajno liječenje simptoma)

Uobičajena doza ovog lijeka je jedna tableta od 10 mg ili 20 mg jednom na dan. Liječnik će odrediti koliko

dugo trebate uzimati ovaj lijek. Tabletu uzmite ujutro prije jela. Vaţno je redovno posjećivati liječnika koji

će nadzirati Vaše simptome i prilagoditi primjenu lijeka.

Simptomatski GERB (umjereni do teški simptomi)

Uobičajena doza ovog lijeka je jedna tableta od 10 mg jednom na dan kroz 4 tjedna. Tabletu uzmite ujutro

prije jela. Ako se nakon 4 tjedna primjene lijeka simptomi vrate, moţda će Vam liječnik savjetovati da

uzimate jednu tabletu od 10 mg na dan prema potrebi.

Zollinger-Ellisonov sindrom

Uobičajena početna doza ovog lijeka su 3 tablete od 20 mg jednom na dan. Ovisno o Vašoj reakciji na

terapiju, Vaš će liječnik moţda prilagoditi dozu. Ako ste na dugotrajnoj terapiji ovim lijekom, vaţno je

redovno posjećivati liječnika koji će nadzirati Vaše simptome i primjenu lijeka.

Za čireve izazvane infekcijom bakterijom H. pylori i spriječavanje njihovog povratka

Uobičajena doza ovog lijeka je 20 mg dvaput dnevno tijekom 7 dana (u kombinaciji s dva antibiotika:

500 mg klaritromicina i 1 g amoksicilina).

Informacije o drugim lijekovima koje uzimate za liječenje infekcije bakterijom H. pylori potraţite u

zasebnim uputama o lijeku za svaki od lijekova.

Bolesnici s oštećenom funkcijom jetre

Bolesnike s oštećenom funkcijom jetre liječnik će s povećanom paţnjom nadzirati na početku

primjene ovog lijeka i tijekom nastavka primjene.

Ako uzmete više Zulbexa nego što ste trebali

Ako uzmete više tableta nego što ste trebali, odmah se javite Vašem liječniku ili u najbliţu bolnicu.

Ponesite sa sobom pakiranje lijeka kako bi liječnik znao što se uzeli.

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Ako ste zaboravili uzeti Zulbex

Ako ste zaboravili uzeti dozu lijeka, uzmite ju čim se sjetite. No, ako je blizu vrijeme za sljedeću dozu,

preskočite zaboravljenu dozu i nastavite uzimati lijek po uobičajenom rasporedu.

Ako zaboravite uzeti ovaj lijek više od 5 dana, javite se Vašem liječniku prije nego što uzmete

sljedeću tabletu.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Zulbex

Olakšanje simptoma će se pojaviti prije nego što je čir u potpunosti izliječen. Zato je vaţno da ne

prekidate uzimanje ovog lijeka sve dok Vam Vaš liječnik tako ne kaţe.

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 uglavnom blage i poboljšaju se bez potrebe za prestankom uzimanja lijeka.

Prestanite uzimati ovaj lijek i odmah posjetite liječnika ako primijetite bilo koju od sljedećih

nuspojava – možda ćete trebati hitno medicinsko liječenje:

alergijske reakcije – znakovi mogu uključivati: iznenadno oticanje lica, teškoće pri disanju,

niski krvni tlak koji moţe izazvati nesvjesticu ili kolaps

česte infekcije, kao što su grlobolja, visoka tjelesna temperatura (vrućica), čirevi u ustima ili

grlu

lakše nastajanje modrica ili krvarenje

Ove nuspojave su rijetke (mogu se javiti u manje od 1 na 1000 osoba).

teški mjehuri na koţi, bolnost, čirevi u ustima i grlu

Ove nuspojave su vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba).

Ostale moguće nuspojave:

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

infekcije

nesanica (poremećaj spavanja)

glavobolja, omaglica

kašalj, upaljeno grlo (faringitis), curenje iz nosa (rinitis)

proljev, povraćanje, mučnina, bolovi u trbuhu, zatvor (konstipacija), napuhnutost (vjetrovi),

dobroćudni polipi u ţelucu

bolovi, bol u leĎima

slabost, bolest sa simptomima sličnim gripi

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

nervoza, omamljenost

upala donjih dišnih puteva (bronhitis)

upala sinusa (sinusitis)

probavne smetnje, suhoća usta, podrigivanje

koţni osip, crvenilo koţe

bol u mišićima, zglobovima ili nogama

infekcija mokraćnog mjehura (infekcija mokraćnog sustava)

bol u prsima

zimica, vrućica

promjene u načinu rada jetre (vidljive u krvnim testovima)

prijelomi kuka, zapešća i kraljeţnice

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

gubitak teka (anoreksija)

depresija

preosjetljivost (alergijske reakcije)

poremećaji vida

nadraţenost ţeluca ili bol u ţelucu

upala usne šupljine (stomatitis), promjene okusa

tegobe s jetrom poput upale jetre (hepatitis) i ţutice (ţutilo koţe i bjelilo očiju), oštećenje mozga

zbog bolesti jetre (jetrena encefalopatija)

osip koji svrbi, plikovi na koţi

znojenje

tegobe s bubrezima

dobivanje na teţini

smanjenje broja bijelih krvnih stanica (vidljivo u krvnim testovima) koje moţe rezultirati

učestalim upalama

smanjenje broja krvnih pločica (trombocita) koje rezultira lakšim krvarenjam ili stvaranjem

modrica nego što je to uobičajeno

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

teške koţne reakcije: eritema multiforme (crvenilo koţe s plikovima), toksična epidermalna

nekroliza (teško oštećenje koţe po tijelu s odvajanjem gornjeg sloja koţe od niţih slojeva po

tijelu), Stevens-Johnsonov sindrom (teški plikovi, guljenje i krvarenje koţe, usta, usana i nosa)

Nepoznate učestalosti (učestalost se ne moţe procijeniti iz dostupnih podataka):

smetenost

otečenost stopala i gleţnjeva

otečenost grudi u muškaraca

niske vrijednosti natrija u krvi koje mogu uzrokovati mučninu, slabost, grčeve u mišićima ili

smetenost

osip, moguće praćen boli u zglobovima

upala crijeva (koja izaziva proljev)

Ako uzimate Zulbex dulje od tri mjeseca, moţe doći do smanjenja razine magnezija u krvi. Niske razine

magnezija mogu se očitovati kao umor, nevoljno stezanje mišića, dezorijentiranost, konvulzije,

omaglica, ubrzan rad srca. Ako primijetite bilo koji od ovih simptoma, odmah obavijestite Vašeg

liječnika. Niske razine magnezija mogu takoĎer 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.

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 Zulbex?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

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

Čuvati na temperaturi ispod 30

Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.

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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 Zulbex sadrži?

Djelatna tvar je rabeprazolnatrij.

Svaka ţelučanootporna tableta sadrţi 10 mg rabeprazolnatrija, što odgovara 9,42 mg

rabeprazola.

Svaka ţelučanootporna tableta sadrţi 20 mg rabeprazolnatrija, što odgovara 18,85 mg

rabeprazola.

Drugi sastojci su: manitol (E421); lagani magnezijev oksid (E530); hidroksipropilceluloza

(E463); djelomično supstituirana hidroksipropilceluloza (E463) i magnezijev stearat (E572) u

jezgri tablete, etilceluloza (E462); lagani magnezijev oksid (E530); hipromelozaftalat;

diacetilirani monogliceridi (E472a); talk (E553b), titanijev dioksid (E171), crveni ţeljezov

oksid (E172) (samo 10 mg), ţuti ţeljezov oksid (E172) (samo 20 mg) u film ovojnici tablete.

Kako Zulbex izgleda i sadržaj pakiranja?

Ţelučanootporne tablete od 10 mg su narančastoruţičaste boje, bikonveksne, okrugle s ukošenim

rubovima, promjera 5,5 mm.

Ţelučanootporne tablete od 20 mg su smećkastoţute boje, bikonveksne i okrugle, promjera 7 mm.

Zulbex 10 mg ţelučanootporne tablete i Zulbex 20 mg ţelučanootporne tablete su dostupne u kutijama

sa 7, 10, 14, 15, 28, 30, 56, 60, 90, 98 ili 100 ţelučanootpornih tableta u blisterima.

U prometu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

KRKA - FARMA d.o.o., Radnička cesta 48, 10 000 Zagreb

ProizvoĎač:

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u rujnu 2017.

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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