Olazin 10 mg raspadljive

Glavna informacija

  • Trgovački naziv:
  • Olazin 10 mg raspadljive tablete za usta
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • raspadljiva tableta za usta
  • Sastav:
  • Urbroj: 1 raspadljiva tableta za usta sadrži 10 mg olanzapina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Farmal d.d., Ludbreg, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Olazin 10 mg raspadljive tablete za usta
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-210505274-01] Urbroj: 381-12-01/14-14-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-210505274
  • Datum autorizacije:
  • 10-12-2014
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Olazin 5 mg raspadljive tablete za usta

Olazin 10 mg raspadljive tablete za usta

olanzapin

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

podatke.

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

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

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

njihovi znakovi bolesti jednaki Vašima.

- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti 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 Olazin i za što se koristi

2. Što morate znati prije nego počnete uzimati Olazin

3. Kako uzimati Olazin

4. Moguće nuspojave

5. Kako čuvati

6. Sadržaj pakiranja i druge informacije

1.

ŠTO JE OLAZIN I ZA ŠTO SE KORISTI

Olazin sadrži djelatnu tvar olanzapin. Olazin pripada skupini lijekova koji se zovu antipsihotici i

koristi se za liječenje sljedećih stanja:

shizofrenije, bolesti sa simptomima kao što su slušna, vidna ili osjetilna priviđenja stvari

koje nisu prisutne, iluzije, neuobičajena sumnjičavost i povučenost. Osobe s tom bolešću

mogu se također osjećati depresivno, tjeskobno ili napeto.

umjerenih do teških epizoda manije, stanja sa simptomima uzbuđenja ili euforije.

Pokazalo

olanzapin

sprječava

ponavljanje

simptoma

bolesnika

bipolarnim

poremećajem u kojih je epizoda manije reagirala na liječenje olanzapinom.

2.

ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI OLAZIN

Nemojte uzimati Olazin

ako ste alergični (preosjetljivi) na olanzapin ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.). Alergijska reakcija može se prepoznati kao osip, svrbež, otečeno lice, otečene

usnice ili nedostatak zraka. Ako Vam se ovo pojavi, obavijestite svog liječnika.

ako od ranije imate dijagnosticirane tegobe s očima kao što su i određene vrste glaukoma

(povišeni očni tlak)

Upozorenja i mjere opreza

Obratite

se svom liječniku ili ljekarniku prije nego uzmete Olazin.

Primjena Olazina u starijih bolesnika s demencijom (zaboravljivošću) se ne preporučuje

jer mogu nastati teške nuspojave.

H A L M E D

10 - 12 - 2014

O D O B R E N O

Lijekovi ove vrste mogu uzrokovati pojavu neuobičajenih pokreta, uglavnom lica ili

jezika. Ako Vam se ovo pojavi nakon uzimanja lijeka Olazin, obratite se svom liječniku.

Vrlo rijetko lijekovi ovog tipa uzrokuju kombinaciju vrućice, ubrzanog disanja, znojenja,

ukočenosti mišića te omamljenosti ili pospanosti. Ako do ovog dođe, odmah se obratite

svom liječniku.

Zapaženo je povećanje tjelesne težine u bolesnika koji uzimaju Olazin. Sa svojim

liječnikom redovito kontrolirajte tjelesnu težinu.

Po potrebi razmotrite da Vas liječnik

uputi nutricionistu ili zatražite pomoć oko planiranja prehrane.

U bolesnika koji uzimaju Olazin zapažena je visoka razina šećera i masnoća u krvi

(trigliceridi

kolesterol).

Prije

početka

uzimanja

lijeka

Olazin

redovito

tijekom

liječenja, potrebno je da liječnik napravi krvne pretrage kako bi provjerio razinu šećera i

određenih masnoća u krvi.

Obavijestite svog liječnika ako ste Vi ili netko drugi u Vašoj obitelji ranije imali krvne

ugruške, jer su lijekovi poput ovih povezani sa stvaranjem krvnih ugrušaka.

Ako bolujete od bilo koje od sljedećih bolesti, obavijestite svog liječnika što je prije moguće:

moždani udar ili „mali“ moždani udar (kratkotrajni simptomi moždanog udara)

Parkinsonova bolest

tegobe s prostatom

zatvor crijeva (paralitički ileus)

bolest jetre ili bubrega

poremećaji krvi

srčana bolest

šećerna bolest

napadaji

Ako bolujete od zaboravljivosti (demencije), a imali ste moždani udar ili „manji“ moždani udar,

Vi ili Vaš skrbnik/član obitelji morate o tome obavijestiti liječnika.

Ako ste starijih od 65 godina, liječnik će Vam možda kao rutinsku mjeru opreza redovito

kontrolirati krvni tlak.

Djeca i adolecenti

Olazin nije za primjenu u bolesnika mlađih od 18 godina.

Drugi lijekovi i Olazin

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

bilo koje druge lijekove.

Dok uzimate Olazin, druge lijekove uzimajte samo ako Vam liječnik kaže da to možete. Ako

uzimate Olazin u kombinaciji s antidepresivima, lijekovima za tjeskobu ili lijekovima koji Vam

pomažu zaspati (trankvilizatori), možete se osjećati omamljeno.

Posebno obavijestite svog liječnika ako uzimate:

lijekove protiv Parkinsonove bolesti

karbamazepin (antiepileptik i stabilizator raspoloženja), fluvoksamin (antidepresiv) ili

ciprofloksacin (antibiotik) – možda će biti potrebno promijeniti dozu lijeka Olazin

H A L M E D

10 - 12 - 2014

O D O B R E N O

Olazin s hranom, pićem i alkoholom

Nemojte

piti

alkohol

uzimate

Olazin

kombinaciji

alkoholom

može

izazvati

omamljenost.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se

svom liječniku za savjet prije nego uzmete ovaj lijek.

Ne smijete uzimati ovaj lijek dok dojite, jer se male količine lijeka Olazin mogu izlučiti u

majčino mlijeko.

Sljedeći

simptomi

mogu

pojaviti

novorođenčadi

majki

koje

koristile

Olazin

posljednjem tromjesečju (zadnja tri mjeseca trudnoće): drhtanje, ukočenost mišića i/ili slabost,

pospanost, uznemirenost, tegobe s disanjem te poteškoće u hranjenju. Ako se u Vašeg djeteta

razvije bilo koji od ovih simptoma, potrebno je obratiti se svom liječniku.

Upravljanje vozilima i strojevima

Kad uzimate Olazin postoji rizik da se osjećate omamljeno. Ako se ovo dogodi, nemojte

upravljati vozilima niti rukovati bilo kakvim alatima ili strojevima. Obavijestite svog liječnika.

Olazin sadrži aspartam

Olazin sadrži aspartam koji je izvor fenilalanina. Može biti štetan u osoba s fenilketonurijom.

3.

KAKO UZIMATI OLAZIN

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Liječnik će Vam reći koliko Olazin tableta morate uzeti i koliko ćete ih dugo uzimati.

Dnevna doza lijeka Olazin iznosi između 5 mg i 20 mg.

Ako Vam se simptomi vrate, posavjetujte se sa svojim liječnikom, ali nemojte prestati uzimati

Olazin dok Vam liječnik to ne kaže.

Olazin tablete morate uzimati jednom dnevno pridržavajući se savjeta svog liječnika.

Pokušajte uzimati tablete svaki dan u isto vrijeme. Nije važno uzimate li lijek s hranom ili bez

nje.

Olazin tablete lako se lome te njima treba pažljivo rukovati. Ne uzimajte tablete mokrim rukama

jer se mogu prelomiti.

Stavite tabletu u usta. Rastopit će se izravno u vašim ustima, pa ćete je moći lako progutati.

Tabletu također možete staviti u punu čašu ili šalicu vode, soka od naranče, soka od jabuke,

mlijeka ili kave, te promiješati. Ako se lijek uzima s pićem, mješavina može promijeniti boju i

postati mutna. Popijte odmah.

Ako uzmete više Olazina nego što ste trebali

Bolesnici koji su uzeli više lijeka Olazin nego što su trebali imaju sljedeće simptome: ubrzan rad

srca, uznemirenost/agresivnost, poteškoće s govorom, neuobičajene pokrete (osobito lica ili

jezika)

sniženu

razinu

svijesti.

Ostali

simptomi

mogu

biti:

akutna

smetenost,

napadaji

(epilepsija),

koma,

kombinacija

vrućice,

ubrzanog

disanja,

znojenja,

ukočenosti

mišića

H A L M E D

10 - 12 - 2014

O D O B R E N O

omamljenosti ili pospanosti, usporavanje disanja, aspiracija, visok krvni tlak ili nizak krvnog

tlaka, poremećaj srčanog ritma. Ako imate bilo koji od navedenih simptoma, odmah se obratite

svom liječniku ili bolnici. Pokažite liječniku pakiranje tableta.

Ako ste zaboravili uzeti Olazin

Uzmite tablete čim se sjetite. Ne uzimajte dvostruku dozu u jednom danu.

Ako prestanete uzimati Olazin

Nemojte prestati uzimati tablete samo zato jer se osjećate bolje. Važno je da nastavite uzimati

Olazin onoliko dugo koliko Vam je liječnik rekao.

Ako naglo prestanete s uzimanjem lijeka Olazin mogu se pojaviti simptomi poput znojenja,

nesanice, nevoljnog drhtanja, tjeskobe ili mučnine i povraćanja. Liječnik Vam može savjetovati

da postupno smanjujete dozu prije prekida liječenja.

U slučaju bilo kakvih 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 javiti kod svakoga.

Odmah obavijestite svog liječnika ako imate:

neuobičajene pokrete (česta nuspojava koja se može pojaviti u najviše 1 na 10 osoba)

uglavnom na licu ili jeziku;

krvne ugruške u venama (manje česta nuspojava koja se može pojaviti u najviše 1 na 100

osoba), posebno u nogama (simptomi uključuju oticanje, bol i crvenilo nogu), koji mogu

putovati krvnim žilama do pluća, uzrokujući bol u prsnom košu i otežano disanje. Ako

primijetite bilo koji od ovih simptoma, odmah zatražite liječnički savjet;

kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića te omamljenosti ili

pospanosti (učestalost ove nuspojave ne može se procijeniti iz dostupnih podataka).

Vrlo česte nuspojave

(mogu se pojaviti u više od 1 na 10 osoba koje uzimaju lijek) uključuju

povećanje tjelesne težine, pospanost i povišene razine prolaktina u krvi. U ranim fazama

liječenja neki bolesnici mogu osjećati omaglicu ili nesvjesticu (uz usporen rad srca), posebno pri

uspravljanju iz ležećeg ili sjedećeg položaja tijela. Ovo obično prolazi samo po sebi, ali ako ne

prođe, javite se liječniku.

Česte nuspojave (mogu se pojaviti u 1 do 10 na 100 osoba koje uzimaju lijek) uključuju

promjene razina nekih krvnih stanica, cirkulirajućih masti u krvi te, u ranim fazama liječenja,

privremena povećanja razine jetrenih enzima; povišene razine šećera u krvi i mokraći; povišene

razine mokraćne kiseline i kreatin fosfokinaze u krvi; pojačan apetit, omaglicu, nemir, nevoljno

drhtanje, neuobičajene pokrete (diskinezije); zatvor; suha usta; osip; slabost; pojačan umor;

zadržavanje vode u tijelu koje dovodi do oticanja ruku, zglobova ili stopala; vrućicu, bol u

zglobovima i seksualne poremećaje kao što su smanjen libido u muškaraca i žena ili erektilna

disfunkcija u muškaraca.

Manje česte nuspojave (mogu se pojaviti u 1 do 10 na 1000 osoba koje uzimaju lijek) uključuju

preosjetljivost (npr. oticanje u ustima i grlu, svrbež, osip); šećernu bolest ili njezino pogoršanje,

ponekad povezano s ketoacidozom (ketoni u krvi i mokraći) ili komom; napadaje, obično

H A L M E D

10 - 12 - 2014

O D O B R E N O

povezane s prethodnom pojavom napadaja (epilepsija) u povijesti bolesti; ukočenost ili grčevi

mišića (uključujući pokrete očiju); poteškoće u govoru; usporen rad srca; osjetljivost na sunčevu

svjetlost; krvarenje iz nosa; nadimanje trbuha (distenzija); gubitak pamćenja ili zaboravljivost;

nemogućnost zadržavanja mokraće (inkontinencija); nemogućnost mokrenja; ispadanje kose;

izostanak ili smanjenje mjesečnice i promjene na grudima u muškaraca i žena, kao što je

poremećaj stvaranja majčinog mlijeka ili abnormalan rast.

Rijetke nuspojave (mogu se pojaviti

1 do 10 na 10000 osoba koje uzimaju lijek) uključuju

sniženje normalne tjelesne temperature, poremećaj srčanog ritma, naglu neobjašnjivu smrt,

upalu gušterače koja uzrokuje jaku bol u trbuhu, vrućicu i mučninu; bolest jetre koja se očituje

žutilom

kože

bjeloočnica;

bolest

mišića

koja

manifestira

neobjašnjivim

bolovima;

produljenu i/ili bolnu erekciju.

Tijekom liječenja olanzapinom u starijih bolesnika s demencijom (zaboravljivošću) mogu

nastati moždani udar, upala pluća, nemogućnost zadržavanja mokraće (inkontinencija), padanje,

izraziti umor, vidne halucinacije (priviđanja), povišenje tjelesne temperature, crvenilo kože i

teškoće pri hodu. Prijavljeno je i nekoliko smrtnih slučajeva u ovoj specifičnoj grupi bolesnika.

U bolesnika koji boluju od Parkinsonove bolesti, Olazin može pogoršati simptome.

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:

Agencija za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju

Roberta Frangeša Mihanovića 9

10 000 Zagreb

Republika Hrvatska

Fax: + 385 (0)1 4884 119

Website: www.halmed.hr

E-mail: nuspojave@halmed.hr

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

KAKO ČUVATI OLAZIN

Ovaj lijek se mora čuvati u originalnom pakiranju (zaštićeno od svjetlosti).

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

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 Olazin sadrži

Djelatna tvar je olanzapin. Jedna raspadljiva tableta za usta sadrži 5 mg ili 10 mg olanzapina.

H A L M E D

10 - 12 - 2014

O D O B R E N O

Drugi sastojci (pomoćne tvari) su: manitol; aspartam; krospovidon; celuloza, mikrokristalična i

magnezijev stearat.

Kako Olazin izgleda i sadržaj pakiranja

Olazin 5 mg raspadljive tablete za usta su žute, okrugle, neobložene tablete, ravne površine i

kosih rubova, s razdjelnim urezom na jednoj strani i utisnutom oznakom „5“ na drugoj strani

tablete. Pomoću razdjelnog ureza tableta se može prelomiti na dva jednaka dijela. Pakirane su po

28 (4x7) tableta u blisteru, u kutiji.

Olazin 10 mg raspadljive tablete za usta su žute, okrugle, neobložene tablete, ravne površine i

kosih rubova, s razdjelnim urezom na jednoj strani i s utisnutom oznakom „10“ na drugoj strani

tablete. Pomoću razdjelnog ureza tableta se može prelomiti na dva jednaka dijela. Pakirane su po

28 (4x7) tableta u blisteru, u kutiji.

Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač

Farmal d.d., 42230 Ludbreg, Branitelja domovinskog rata 8, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u

Prosincu, 2014.

H A L M E D

10 - 12 - 2014

O D O B R E N O

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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

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