Tyrez 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Tyrez 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 10 mg bisoprololfumarata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Alkaloid - int d.o.o., Ljubljana, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Tyrez 10 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-136028630-01] Urbroj: 381-12-01/70-16-02

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-136028630
  • Datum autorizacije:
  • 29-10-2016
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku:

Informacije za bolesnika

TYREZ 2,5 mg filmom obložene tablete

TYREZ 5 mg filmom obložene tablete

TYREZ 10 mg filmom obložene tablete

bisoprololfumarat

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

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

i svaku moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Tyrez

i za što se koristi?

Što morate znati prije nego počnete uzimati Tyrez?

Kako uzimati Tyrez?

Moguće nuspojave

Kako čuvati Tyrez?

Sadržaj pakiranja i druge informacije

1.

Što je Tyrez

i za što se koristi?

Djelatna tvar lijeka Tyrez je bisoprolol. Bisoprolol pripada skupini lijekova koji se nazivaju beta-

blokatori. Ova skupina lijekova djeluje tako da utječe na odgovor tijela na neke živčane impulse,

naročito u srcu. Kao rezultat, bisoprolol usporava otkucaje srca te djeluje tako da srce može

učinkovitije pumpati krv po tijelu. Pri tome, srce može raditi bolje, uz manje zahtjeve za krvi i

kisikom. Do zatajenja srca dolazi kada je srčani mišić oslabljen i nije u mogućnosti pumpati dovoljno

krvi za potrebe tijela.

Tyrez 2,5 mg filmom obložene se koriste kod:

stabilnog, kroničnog (dugotrajnog) srčanog zatajenja, u kombinaciji s drugim lijekovima (ACE

inhibitorima, diureticima ili srčanim glikozidima).

Tyrez 5 mg filmom obložene tablete i Tyrez 10 mg filmom obložene tablete se koriste kod:

hipertenzije (povišenog krvnog tlaka);

koronarne bolesti srca odnosno angine pektoris (bolovi u prsima uzrokovani suženjem arterija

koje vode krv u srce);

stabilnog, kroničnog (dugotrajnog) srčanog zatajenja, u kombinaciji s drugim lijekovima (ACE

inhibitorima, diureticima ili srčanim glikozidima).

2.

Što morate znati prije nego počnete uzimati Tyrez?

Nemojte uzimati Tyrez:

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

ako imate tešku astmu;

ako imate teške probleme s cirkulacijom u Vašim udovima (kao što je Raynaudov sindrom),

stanje koje može uzrokovati da Vaši prsti ruku i nogu trnu ili postanu blijedi ili poplave;

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ako imate neliječeni feokromocitom (rijedak tumor nadbubrežne žlijezde);

metabolička acidoza (stanje kod kojeg je previše kiseline u krvi).

Isto tako, nemojte uzimati Tyrez ako imate neki od sljedećih problema sa srcem

akutno srčano zatajenje;

pogoršanje srčanog zatajenja koje zahtjeva injekciju lijeka u venu, što pojačava sposobnost

kontrakcije srca;

kardiogeni šok koji je ozbiljno akutno stanje srca koji uzrokuje nizak krvni tlak i zatajenje

cirkulacije;

određena srčana stanja pri kojima dolazi do vrlo usporenog pulsa ili nepravilnog ritma srca (AV

blok drugog ili trećeg stupnja, sindrom bolesnog sinusnog čvora, tzv. „

sick sinus sindrom

“,

sinus-atrijski blok);

nizak krvni tlak koji uzrokuje probleme;

usporeni puls koji uzrokuje probleme.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Tyrez ako se neko od sljedećih stanja

odnosi na Vas; liječnik će možda odrediti dodatne mjere (npr. uvesti dodatno liječenje ili češće

kontrole):

šećerna bolest;

strogo gladovanje;

određena stanja kao što su poremećaji srčanog ritma ili teški bolovi u prsima pri mirovanju

(Prizmentalova angina);

problemi s bubrezima ili jetrom;

blaži problemi s cirkulacijom u rukama i nogama;

kronična bolest pluća ili manje teška astma;

imate ili ste imali psorijazu ili ako uži član Vaše obitelji boluje od psorijaze (kožna bolest s

pojavom uzdignutih, crvenih, ljuskavih žarišta);

tumor nadbubrežne žlijezde (feokromocitom) zbog kojeg uzimate druge lijekove;

poremećaj rada štitnjače.

Dodatno, recite Vašem liječniku:

ako ste planirani za desenzibilizacijsko liječenje (npr. za sprječavanje alergijskog rinitisa) jer

Tyrez može pojačati vjerojatnost pojave alergijske reakcije ili njenu težinu;

ako trebate biti podvrgnuti anesteziji (npr. radi operacije) jer Tyrez može imati utjecaja na

reakciju Vašeg tijela u ovoj situaciji.

Odmah obavijestite svog liječnika ako bolujete od kronične bolesti pluća ili manje teške astme, a

nakon uzimanja lijeka Tyrez osjetite poteškoće poput otežanog disanja, kašlja, dahtanja nakon fizičke

aktivnosti, itd.

Djeca i adolescenti

Ne preporučuje se primjena Tyreza u djece i adolescenata.

Drugi lijekovi i Tyrez:

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

druge lijekove.

Nemojte uzimati sljedeće lijekove uz Tyrez bez posebne preporuke svojeg liječnika:

određeni lijekovi za liječenje visokog krvnog tlaka, angine pektoris ili nepravilnih otkucaja srca

(antagonisti kalcija kao što su verapamil ili diltiazem);

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određeni lijekovi za liječenje nepravilnog ritma rada srca (antiaritmika klase I kao što su kinidin,

dizopiramid, lidokain, fenitoin, flekainid, propafenon);

određeni lijekovi koji se koriste za snižavanje krvnog tlaka kao što su metildopa, klonidin,

moksonidin i rilmenidin.

Međutim,

nemojte prestati uzimati ove lijekove

bez prethodnog savjetovanja s Vašim liječnikom.

Provjerite s Vašim liječnikom prije uzimanja sljedećih lijekova uz Tyrez; Vaš liječnik će možda trebati

češće provjeravati Vaše stanje:

određeni lijekovi koji se primjenjuju za liječenje visokog krvnog tlaka i angine pectoris

(antagonisti kalcija dihidropiridinskog tipa kao što su felodipin i amlodipin);

određeni lijekovi koji se primjenjuju za liječenje nepravilnih ili abnormalnih otkucaja srca

(antiaritmici klase III kao što je amiodaron);

beta-blokatori za vanjsku primjenu (kao što su timolol kapi za oči kod liječenja glaukoma)

određeni lijekovi za liječenje npr. Alzheimerove bolesti ili glaukoma (parasimpatomimetici kao

što su takrin ili karbakol) ili lijekovi za liječenje akutnih problema sa srcem (simpatomimetici kao

što su izoprenalin i dobutamin);

antidijabetici uključujući inzulin;

anestetici (tijekom operativnih zahvata);

digitalis, lijek za liječenje zatajenja srca;

lijekovi poznati kao nesteroidni protuupalni lijekovi koji se koriste za liječenje artritisa, boli ili

upala (npr. ibuprofen ili diklofenak);

bilo koji lijekovi koji mogu sniziti krvni tlak kao željeni ili neželjeni učinak kao što su

antihipertenzivi, lijekovi za liječenje depresije (triciklički antidepresivi kao što su imipramin ili

amitriptilin), određeni lijekovi za liječenje epilepsije ili tijekom anestezije (barbiturati kao što je

fenobarbital) ili određeni lijekovi za liječenje mentalnih bolesti karakteriziranih gubitkom kontakta

sa stvarnošću (fenotiazini kao što je levomepromazin)

meflokin (lijek koji se primjenjuje za profilaksu ili liječenje malarije);

lijekovi za liječenje depresije koji se nazivaju inhibitori monoaminooksidaze (osim MAO-B

inhibitora) kao što je moklobemid.

Trudnoća i dojenje

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

za savjet prije nego što dobijete ovaj lijek.

Postoji rizik da bi Tyrez mogao naškoditi Vašem djetetu. Vaš će liječnik odlučiti smijete li uzimati

Tyrez tijekom trudnoće.

Nije poznato prelazi li bisoprolol u majčino mlijeko. Stoga se dojenje tijekom liječenja Tyrezom ne

preporučuje.

Upravljanje vozilima i strojevima

Ovisno o tome kako podnosite lijek, Vaša sposobnost upravljanja vozilima i strojevima može biti

narušena. Molimo, budite naročito oprezni na početku liječenja, kod povećavanja doze ili promjena u

liječenju, kao i u kombinaciji s alkoholom.

3.

Kako uzimati Tyrez?

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

liječnikom ili ljekarnikom ako niste sigurni.

Liječenje lijekom Tyrez zahtijeva redovito praćenje Vašeg stanja od strane liječnika. Ovo je naročito

potrebno na početku terapije, tijekom povećanja doze i kada prestajete s liječenjem.

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Tablete uzimajte jednom dnevno ujutro prije, za vrijeme ili nakon doručka, s malo vode.

Tablete Tyrez imaju urez na jednoj strani i mogu se razdijeliti na jednake doze.

Liječenje lijekom Tyrez obično je dugotrajno.

Kronično zatajenje srca

Liječenje bisoprololom započinje se s niskom dozom koja se postupno povećava. O povećanju doze

odlučuje liječnik, i to se obično radi na sljedeći način:

1,25 mg jedanput dnevno tijekom 7 dana;

2,5 mg jedanput dnevno tijekom slijedećih 7 dana;

3,75 mg jedanput dnevno tijekom slijedećih 7 dana;

5 mg jedanput dnevno tijekom slijedeća 4 tjedna;

7,5 mg jedanput dnevno tijekom slijedeća 4 tjedna;

10 mg jedanput dnevno kao terapija održavanja.

Najveća preporučena doza je 10 mg jedanput dnevno.

Ovisno o tome kako podnosite lijek, Vaš liječnik može odlučiti produljiti vrijeme između povećanja

doza.

Ako se Vaše stanje pogorša, ili više ne podnosite lijek, dozu će možda trebati ponovo smanjiti ili

liječenje prekinuti. U nekih bolesnika može biti dovoljna doza održavanja manja od 10 mg

bisoprolola.

Vaš liječnik će Vam objasniti kako trebate postupiti.

Ako je potreban prekid liječenja, Vaš liječnik će Vam obično savjetovati postepeno smanjenje doze jer

se, u suprotnom, Vaše zdravstveno stanje može pogoršati.

Povišeni krvni tlak i angina pektoris

Liječenje je potrebno započeti niskim dozama koje se potom lagano povećavaju. U svim slučajevima

doziranje je potrebno individualno prilagođavati, naročito prema pulsu i uspješnosti terapije.

Kod obje navedene indikacije uobičajena doza je 5 mg bisoprolola jednom na dan.

Ako je potrebno, dozu se može povećati na 10 mg bisoprolola jednom na dan.

Maksimalna preporučena doza je 20 mg bisoprolola jednom na dan.

Bolesnici s oštećenjem funkcije bubrega ili jetre

U bolesnika s poremećajima rada jetre ili bubrega, blage do umjerene jakosti, u pravilu nije

potrebno prilagođavanje doze. U bolesnika s terminalnim bubrežnim zatajenjem (klirens kreatinina

< 20 ml/min) i U bolesnika s teškim poremećajima rada jetre, dnevna doza bisoprolola ne smije biti

veća od 10 mg.

Starije osobe

Nije potrebno prilagođavanje doze.

Primjena u djece i adolescenata:

Ne preporučuje se primjena Tyreza u djece i adolescenata.

Ako uzmete više Tyreza

nego što ste trebali

Ako ste uzeli više Tyrez

tableta nego što ste trebali odmah obavijestite svog liječnika. Vaš liječnik će

odlučiti koje je mjere potrebno poduzeti. Uvijek sa sobom imajte originalnu kutiju lijeka, bez obzira

ima li u njoj još tableta. Znakovi predoziranja mogu uključivati usporene otkucaje srca, značajan pad

krvnog tlaka, teške probleme s disanjem, osjećaj vrtoglavice ili drhtanje (radi smanjenja šećera u krvi).

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Ako ste zaboravili uzeti Tyrez

Ako ste zaboravili uzeti lijek uzmite svoju uobičajenu dozu sljedeće jutro. Nemojte uzeti dvostruku

dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Tyrez

Nikada nemojte prestati s uzimanjem Tyreza bez savjetovanja sa svojim liječnikom. U suprotnom,

Vaše zdravstveno stanje bi se moglo ozbiljno pogoršati. Liječenje se ne smije naglo prekidati naročito

u bolesnika s

anginom pektoris.

Ako je prekid liječenja potreban, liječnik će Vas uputiti kako

postepeno smanjivati dozu.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili

ljekarniku.

4.

Moguće nuspojave

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

Najozbiljnije nuspojave odnose se na funkciju srca:

• usporavanje rada srca (vrlo česta nuspojava; može se javiti u više od 1 na 10 osoba)

• pogoršanje zatajenja srca (česta nuspojava; može se javiti u manje od 1 na 10 osoba)

• polagani ili nepravilan rad srca (manje česta nuspojava; može se javiti u manje od 1 na 100 osoba).

Ako osjećate omaglicu i slabost, ili imate probleme s disanjem, molimo obratite se Vašem liječniku

što je prije moguće.

U nastavku su navedene ostale nuspojave koje se mogu pojaviti tijekom liječenja bisoprololom.

Nuspojave su razvrstane prema učestalosti pojavljivanja.

Česte nuspojave

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

nizak krvni tlak;

osjećaj hladnoće ili gubitak osjeta u rukama ili nogama;

umor*, opća slabost

, malaksalost(u bolesnika s hipertenzijom i koronarnom bolešću srca)*,

omaglica*, glavobolja*;

probavne tegobe kao što su mučnina, povraćanje, proljev, zatvor.

Manje česte nuspojave

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

poremećaji spavanja;

depresija;

pad krvnog tlaka (omaglica) nakon ustajanja u bolesnika sa zatajenjem srca;

problemi s disanjem u bolesnika s astmom ili kroničnom opstruktivnom bolesti pluća;

mišićna slabost i grčevi.

Rijetke nuspojave

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

odstupanje od normalnih vrijednosti krvnih testova jetrene funkcije ili razine masnoća u krvi;

smanjena količina suza;

oslabljen sluh;

curenje iz nosa (alergijski rinitis);

upala jetre koja može uzrokovati žutilo kože ili bjeloočnica;

reakcije slične alergiji kao što su svrbež, crvenilo, osip;

smetnje potencije;

iznenadan prolazan gubitak svijesti:

noćne more, halucinacije.

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Vrlo rijetke nuspojave

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

iritacija i crvenilo oka (konjunktivitis);

gubitak kose;

pojava ili pogoršanje ljuskavog osipa kože (psorijaze); osip sličan psorijazi.

U bolesnika s hipertenzijom i anginom pektoris ove su nuspojave zabilježene kao manje česte.

*Ove nuspojave događaju se posebno na početku liječenja. U pravilu su blage i obično nestaju za 1-2

tjedna.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Tyrez?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

odnosi se na zadnji dan navedenog mjeseca.

Tyrez 2,5 mg filmom obložene tablete

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

Tyrez 5 mg i 10 mg filmom obložene tablete

Čuvati u originalnom pakiranju, radi zaštite od vlage.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Tyrez sadrži?

Djelatna tvar je bisoprololfumarat.

Tyrez 2,5 mg filmom obložene tablete

Jedna filmom obložena tableta sadrži 2,5 mg bisoprololfumarata.

-

Drugi sastojci su:

Jezgra:

silicificirana mikrokristalična celuloza;

krospovidon; gliceroldibehenat.

Film-ovojnica

: Opadry white Y-1-7000 (hipromeloza; titanijev dioksid (E171); makrogol 400)

Tyrez 5 mg filmom obložene tablete

Jedna filmom obložena tableta sadrži 5 mg bisoprololfumarata.

-

Drugi sastojci su:

Jezgra:

silicificirana mikrokristalična celuloza

;

krospovidon; gliceroldibehenat.

Film-ovojnica

: Opadry yellow 02 B 32859 (hipromeloza; titanijev dioksid (E171); makrogol 400;

žuti željezov oksid (E172))

Tyrez 10 mg filmom obložene tablete

Jedna filmom obložena tableta sadrži 10 mg bisoprololfumarata.

-

Drugi sastojci su:

Jezgra:

silicificirana mikrokristalična celuloza

;

krospovidon; gliceroldibehenat.

Film-ovojnica

: Opadry yellow 02 F 32202 (hipromeloza; titanijev dioksid (E171); makrogol 400; žuti

željezov oksid (E172)).

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Kako Tyrez izgleda i sadržaj pakiranja?

Tyrez 2,5 mg filmom obložene tablete su bijele, okrugle, bikonveksne filmom obložene tablete

promjera približno 7 mm, s urezom na jednoj strani. Tableta se može razdijeliti na jednake doze.

30 (3x10) filmom obloženih tableta u PVC/PVdC/Al blisteru, u kutiji.

Tyrez 5 mg filmom obložene tablete su žute, okrugle, bikonveksne filmom obložene tablete

promjera približno 7 mm, s urezom na jednoj strani. Tableta se može razdijeliti na jednake doze.

30 (3x10) filmom obloženih tableta u PVC/PVdC/Al blisteru, u kutiji.

Tyrez 10 mg filmom obložene tablete

su smećkasto-žute, okrugle, bikonveksne filmom obložene

tablete promjera približno 7 mm, s urezom na jednoj strani. Tableta se može razdijeliti na jednake

doze.

30 (3x10) filmom obloženih tableta u PVC/PVdC/Al blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

Alkaloid d.o.o.

Ulica grada Vukovara 226 F

10 000 Zagreb

Tel: +385 1 63 11 920

Fax: +385 1 63 11 922

e-mail: alkaloid@alkaloid.hr

Proizvođač:

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana – Črnuče, Slovenija

Način i mjesto izdavanja lijeka:

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u listopadu 2016.

H A L M E D

29-10-2016

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

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

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