Caspofungin Accord

Glavna informacija

  • Trgovački naziv:
  • Caspofungin Accord
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Caspofungin Accord
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Antimikotika za sustavnu uporabu
  • Područje terapije:
  • aspergiloza

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/004134
  • Datum autorizacije:
  • 11-02-2016
  • EMEA koda:
  • EMEA/H/C/004134
  • Zadnje ažuriranje:
  • 26-02-2018

Izvješće o ocjeni javnog

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/858611/2015

EMEA/H/C/004134

EPAR, sažetak za javnost

Caspofungin Accord

kaspofungin

Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Caspofungin

Accord. Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u te

uvjete za njegovu primjenu. Svrha sažetka nije davati praktične savjete o korištenju lijeka Caspofungin

Accord.

Praktične informacije o korištenju lijeka Caspofungin Accord pročitajte u uputi o lijeku, odnosno

obratite se svojem liječniku ili ljekarniku.

Što je Caspofungin Accord i za što se koristi?

Caspofungin Accord je antifungalni lijek koji se koristi za liječenje odraslih, adolescenata i djece s:

invazivnom kandidijazom (vrstom gljivične infekcije koju uzrokuje gljivica Candida);

invazivnom aspergilozom (drugom vrstom gljivične infekcije koju uzrokuje gljivica Aspergillus) u

slučaju izostanka odgovora na liječenje ili u slučaju kada bolesnik ne podnosi amfotericin B ili

itrakonazol (druge antifungalne lijekove);

sumnjom na gljivične infekcije (uzrokovane gljivicama kao što su Candida ili Aspergillus) u slučaju

kada je bolesnik febrilan (ima groznicu) i ima neutropeniju (nisku razinu bijelih krvnih stanica).

Caspofungin Accord je prašak od kojeg se priprema otopina za intravensku infuziju (drip). Sadrži

djelatnu tvar kaspofungin.

Caspofungin Accord je „generički lijek”. To znači da je Caspofungin Accord sličan „referentnom lijeku”

koji je već odobren u Europskoj uniji (EU) pod nazivom Cancidas. Više informacija o generičkim

lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje

Caspofungin Accord

EMA/858611/2015

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Kako se Caspofungin Accord koristi?

Caspofungin Accord se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u

liječenju invazivnih gljivičnih infekcija. Od lijeka Caspofungin Accord mora se napraviti koncentrirana

otopina koju je potrebno razrijediti prije uporabe uz pomoć sredstva koje ne sadrži glukozu.

Lijek se daje jedanput dnevno putem polagane infuzije u trajanju od oko jedan sat. U odraslih,

liječenje počinje početnom dozom od 70 mg, a nastavlja se dnevnom dozom od 50 mg ili 70 mg ako

bolesnik ima više od 80 kg. Odraslim bolesnicima koji imaju umjerenih problema s jetrom daje se

manja doza.

U bolesnika u dobi od 12 mjeseci do 17 godina, doza ovisi o tjelesnoj površini bolesnika (koja se

izračunava na osnovi visine i težine bolesnika). U djece mlađe od 12 mjeseci, Caspofungin Accord treba

koristiti s oprezom jer lijek nije u dovoljnoj mjeri ispitan za tu dobnu skupinu.

Liječenje se nastavlja nakon izlječenja infekcije u trajanju od najviše dva tjedna.

Kako djeluje Caspofungin Accord?

Djelatna tvar u lijeku Caspofungin Accord, kaspofungin, pripada skupini antifungalnih lijekova poznatih

pod nazivom „ehinokandini”. Djeluje tako da ometa stvaranje sastavnice stanice gljivice koja se naziva

„polisaharid glukan”, i potrebna je za opstanak i rast gljivice. Stanice gljivice liječene lijekom

Caspofungin Accord imaju nepotpuno razvijene ili oštećene stanične stjenke što ih čini krhkima,

onemogućava njihov rast i uzrokuje njihovo umiranje. Popis gljivica protiv kojih je Caspofungin Accord

aktivan dostupan je u sažetku opisa svojstava lijeka (također dio EPAR-a).

Kako je Caspofungin Accord ispitivan?

Tvrtka je pružila podatke o kaspofunginu iz objavljene literature. Nisu bila potrebna dodatna ispitivanja

jer je Caspofungin Accord generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i Cancidas.

Koje su koristi i rizici lijeka Caspofungin Accord?

Budući da je Caspofungin Accord generički lijek, smatra se da su njegove koristi i rizici isti kao i oni

referentnog lijeka.

Zašto je Caspofungin Accord odobren?

Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima

EU-a, potvrđeno da je Caspofungin Accord usporediv s lijekom Cancidas. Stoga je stav CHMP-a da

koristi nadmašuju utvrđene rizike, kao i kod lijeka Cancidas. Odbor je preporučio izdavanje odobrenja

za primjenu lijeka Caspofungin Accord u EU-u.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Caspofungin Accord?

Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Caspofungin

Accord. Na temelju tog plana u sažetak opisa svojstava lijeka i uputu o lijeku za Caspofungin Accord

uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni

djelatnici i bolesnici trebaju pridržavati.

Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom

Caspofungin Accord

EMA/858611/2015

Stranica 3/3

Ostale informacije o lijeku Caspofungin Accord

Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Caspofungin Accord nalaze se na

internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public

assessment reports. Više informacija o terapiji lijekom Caspofungin Accord pročitajte u uputi o lijeku

(također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.

Cjelovito izvješće EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za korisnika

Caspofungin Accord 50 mg prašak za koncentrat za otopinu za infuziju

Caspofungin Accord 70 mg prašak za koncentrat za otopinu za infuziju

kaspofungin

Pažljivo pročitajte cijelu uputu prije nego Vi ili Vaše dijete počnete primati ovaj lijek jer sadrži

Vama važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru 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 Caspofungin Accord i za što se koristi

Što morate znati prije nego počnete primati Caspofungin Accord

Kako primjenjivati Caspofungin Accord

Moguće nuspojave

Kako čuvati Caspofungin Accord

Sadržaj pakiranja i druge informacije

1.

Što je Caspofungin Accord i za što se koristi

Što je Caspofungin Accord

Caspofungin Accord sadrži lijek koji se zove kaspofungin. On pripada skupini lijekova koji se zovu

antimikotici.

Za što se Caspofungin Accord koristi

Caspofungin Accord se koristi za liječenje sljedećih infekcija u djece, adolescenata i odraslih:

ozbiljne gljivične infekcije u tkivima ili organima (nazvane „invazivna kandidijaza“). Tu

infekciju uzrokuje gljivica (kvasac) pod nazivom Candida.

Osobe koje bi mogle dobiti ovu vrstu infekcije uključuju osobe koje su nedavno operirane ili

osobe čiji je imunološki sustav oslabljen. Vrućica i zimica koje ne reagiraju na antibiotike su

najčešći znakovi ovog tipa infekcije.

gljivične infekcije nosa, nosnih sinusa ili pluća (nazvane „invazivna aspergiloza“) ukoliko drugi

antimikotici nisu pomogli ili su uzrokovali pojavu nuspojava. Ovu infekciju uzrokuje plijesan

pod nazivom Aspergilus.

Osobe koje bi mogle dobiti ovu vrstu infekcije uključuju osobe koje primaju kemoterapiju,

osobe koje su imale transplantaciju ili osobe čiji je imunološki sustav oslabljen.

stanja u kojima postoji sumnja na gljivičnu infekciju, ako imate vrućicu i smanjeni broj bijelih

krvnih stanica, koja nisu poboljšana nakon terapije antibioticima. Osobe u kojih postoji rizik od

gljivične infekcije uključuju osobe koje su nedavno operirane i osobe čiji je imunološki sustav

oslabljen.

Kako Caspofungin Accord djeluje

Caspofungin Accord djeluje na gljivice čineći njihovu staničnu stijenku krhkom i sprečavajući njihov

rast. Na taj način zaustavlja širenje infekcije i daje prirodnoj obrani tijela priliku da se riješi infekcije.

2.

Što morate znati prije nego počnete primati Caspofungin Accord

Nemojte primjenjivati Caspofungin Accord

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

Ako niste sigurni, obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite ovaj

lijek.

Upozorenja i mjere opreza

Obratite se svom liječniku, medicinskoj sestri ili ljekarniku prije nego primite Caspofungin Accord :

ako ste alergični na bilo koji drugi lijek

ako ste ikada imali tegobe s jetrom - možda ćete trebati drugačiju dozu ovog lijeka

ako već primate ciklosporin (koristi se za sprečavanje odbacivanja presađenog organa ili kako bi

se potisnuo Vaš imunološki sustav). Vaš će liječnik možda morati napraviti dodatne krvne

pretrage za vrijeme liječenja.

ako ste ikada imali druge zdravstvene tegobe.

Ako se nešto od gore navedenog odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku,

medicinskoj sestri ili ljekarniku prije nego primite Caspofungin Accord .

Caspofungin Accord također može uzrokovati ozbiljne kožne nuspojave kao što su Stevens-Johnsonov

sindrom (SJS) i toksična epidermalna nekroliza (TEN).

Drugi lijekovi i Caspofungin Accord

Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste

mogli uzeti bilo koje druge lijekove. Ovo uključuje i lijekove koje ste nabavili bez recepta, uključujući

i biljne lijekove. Caspofungin Accord može utjecati na djelovanje drugih lijekova. Također, drugi

lijekovi mogu utjecati na djelovanje lijeka Caspofungin Accord .

Obavijestite svog liječnika, medicinsku sestru ili ljekarnika ako uzimate neki od navedenih lijekova:

ciklosporin ili takrolimus (koriste se za sprečavanje odbacivanja presađenog organa ili za

suzbijanje Vašeg imunološkog sustava). Vaš će liječnik možda morati napraviti dodatne krvne

pretrage za vrijeme Vašeg liječenja

neki lijekovi za liječenje HIV infekcije kao što su efavirenz ili nevirapin

fenitoin ili karbamazepin (koriste se za liječenje epileptičkih napadaja)

deksametazon (steroidni lijek)

rifampicin (antibiotik).

Ako se nešto od gore navedenog odnosi na Vas (ili ako niste sigurni) obratite se svom liječniku,

medicinskoj sestri ili ljekarniku prije nego primite Caspofungin Accord .

Trudnoća i dojenje

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.

Caspofungin Accord nije ispitan u trudnica. Smije se primijeniti u trudnoći samo ako moguća

korist opravdava mogući rizik za dijete.

Žene koje primaju Caspofungin Accord ne smiju dojiti.

Upravljanje vozilima i strojevima

Nema podataka koji ukazuju na to da Caspofungin Accord utječe na sposobnost upravljanja vozilima

ili rada sa strojevima.

3.

Kako primjenjivati Caspofungin Accord

Caspofungin Accord će Vam uvijek pripremiti i primijeniti zdravstveni radnik.Caspofungin Accord

će Vam biti primijenjen:

jedanput na dan

sporom injekcijom u venu (intravenska infuzija)

tijekom približno sat vremena.

Liječnik će odrediti trajanje liječenja i koliko ćete lijeka Caspofungin Accord primiti svakog dana.

Liječnik će pratiti koliko dobro lijek djeluje na Vas. Ako je Vaša tjelesna težina veća od 80 kg, doza

će se morati prilagoditi.

Djeca i adolescenti

Doza lijeka za djecu i adolescente može se razlikovati od doze za odrasle.

Akoprimite više lijeka Caspofungin Accord nego što ste trebali

Liječnik će odlučiti koliko lijeka Caspofungin Accord trebate primiti i koliko dugo svaki dan. Ako ste

zabrinuti da ste možda primili previše lijeka Caspofungin Accord , odmah obavijestite svog liječnika

ili medicinsku sestru.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, medicinskoj

sestri 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 ili medicinsku sestru ukoliko primijetite neku od sljedećih

nuspojava - možda ćete trebati hitnu medicinsku pomoć:

osip, svrbež, osjećaj topline, oticanje lica, usana ili grla uz otežano disanje – možda imate

histaminsku reakciju na lijek.

otežano disanje uz piskanje pri disanju ili osip koji se pogoršava - možda imate alergijsku

reakciju na ovaj lijek.

kašalj, ozbiljne poteškoće pri disanju – ako ste odrasla osoba i imate invazivnu aspergilozu,

možda Vam se javljaju ozbiljne poteškoće s disanjem koje mogu uzrokovati zatajenje disanja.

osip, guljenje kože, ranice na sluznici, koprivnjača, velika područja kože koja se guli.

Kao i sa svakim lijekom koji se izdaje na recept, neke nuspojave mogu biti ozbiljne. Pitajte svog

liječnika za dodatne informacije.

Ostale nuspojave zabilježene u odraslih osoba uključuju

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

Smanjena razina hemoglobina (smanjena količina tvari koja prenosi kisik u krvi), smanjeni broj

bijelih krvnih stanica

Smanjena količina albumina (vrsta bjelančevina) u krvi, smanjena razina kalija ili niske razine

kalija u krvi

Glavobolja

Upala vene

Nedostatak zraka

Proljev, mučnina ili povraćanje

Promjene nekih laboratorijskih krvnih testova (uključujući povišene vrijednosti nekih jetrenih

proba)

Svrbež, osip, crvenilo kože ili znojenje više nego uobičajeno

Bolovi u zglobovima

Zimica, vrućica

Svrbež na mjestu injekcije.

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

Promjene nekih laboratorijskih krvnih testova (uključujući i bolest zgrušavanja krvi, trombocita,

crvenih krvnih stanica ili bijelih krvnih stanica)

Gubitak teka, povećana količina vode u organizmu, disbalans soli u organizmu, povišeni šećer u

krvi, niske razine kalcija u krvi, povišene razine kalcija u krvi, niske razine magnezija u krvi,

povišene razine kiseline u krvi

Dezorijentiranost, osjećaj nervoze, nesanica

Osjećaj omaglice, smanjeni osjet (osobito na koži), tresavica, osjećaj pospanosti, promjene

osjeta okusa, trnci ili obamrlost

Zamagljen vid, pojačano suzenje, otečeni kapci, žutilo bjeloočnica

Osjećaj ubrzanih ili nepravilnih otkucaja srca, ubrzani otkucaji srca, nepravilni otkucaji srca,

poremećen srčani ritam, zatajenje srca

Crvenilo uz osjećaj vrućine, navale vrućine, visok krvni tlak, nizak krvni tlak, crvenilo duž

krvne žile koja je jako osjetljiva na dodir

Stezanje mišića oko dišnih puteva koje dovodi do piskanja pri disanju ili kašljanja, ubrzano

disanje, nedostatak zraka koji bolesnika budi iz sna, nedostatak kisika u krvi, neuobičajeni

zvukovi pri disanju, zvukovi pucketanja u plućima, piskanje pri disanju, začepljenost nosa,

kašalj, bol u grlu

Bolovi u trbuhu, bolovi u gornjem dijelu trbuha, nadutost, zatvor, otežano gutanje, suha usta,

probavne tegobe, vjetrovi, nelagoda u trbuhu, oticanje zbog nakupljanja tekućine oko trbuha

Smanjen protok žuči, povećana jetra, žuta boja kože i/ili bjeloočnica, kemijski uzrokovano

oštećenje jetre, poremećaj jetre

Promjene tkiva kože, generalizirani svrbež, koprivnjača, osip raznolikog izgleda, promjene

kože, crvene mrlje na rukama i nogama koje često svrbe, a ponekad se javljaju i na licu i ostatku

tijela

Bolovi u leđima, bolovi u rukama i nogama, bolovi u kostima, bolovi u mišićima, slabost mišića

Gubitak funkcije bubrega, iznenadni gubitak funkcije bubrega

Bol na mjestu katetera, znakovi na mjestu injekcije (crvenilo, tvrdi otok, bol, oticanje,

nadraženost, osip, koprivnjača, curenje tekućine iz katetera u tkivo), upala vene na mjestu

injekcije

Povišene vrijednosti krvnog tlaka i promjene nekih laboratorijskih krvnih testova (uključujući

bubrežne elektrolite i testove zgrušavanja), povišene razine lijekova koje uzimate koji slabe

imunološki sustav

Nelagoda u prsima, bol u prsima, osjećaj promjene tjelesne temperature, opće loše osjećanje,

bolovi, oticanje lica, oticanje zglobova, ruku ili nogu, oticanje, osjetljivost, osjećaj umora.

Nuspojave u djece i adolescenata

Vrlo često (mogu se javiti u više od 1 na 10 osoba):

Vrućica

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

Glavobolja

Ubrzani otkucaji srca

Crvenilo uz osjećaj vrućine, nizak krvni tlak

Promjene nekih laboratorijskih krvnih testova (povišene vrijednosti nekih jetrenih proba)

Svrbež, osip

Bol na mjestu katetera

Zimica

Promjene nekih krvnih laboratorijskih testova

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 Caspofungin Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici . Rok

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati u hladnjaku (2

C – 8

Pripremljeni Caspofungin Accord mora se odmah primijeniti jer ne sadrži sastojke koji bi zaustavili

rast bakterija. Samo osposobljeni zdravstveni radnik,, koji je pročitao cijele upute, smije pripremiti

lijek (vidjeti niže “Upute za rekonstituciju i razrjeđivanje lijeka Caspofungin Accord ”).

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 Caspofungin Accord sadrži

Djelatna tvar je kaspofungin. Jedna bočica lijeka Caspofungin Accord sadrži 50 ili 70 mg

kaspofungina (u obliku kaspofunginacetata).

Drugi sastojci su saharoza, manitol, sukcinatna kiselina i natrijev hidroksid (vidjeti dio 2. Što

morate znati prije nego počnete primati Caspofungin Accord ).

Kako Caspofungin Accord izgleda i sadržaj pakiranja

Caspofungin Accord prašak za koncentrat za otopinu za infuziju je bijeli do bjelkasti prašak.

Jedno pakiranje sadrži jednu bočicu s praškom.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

Ujedinjeno Kraljevstvo

Proizvođač

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF

Ujedinjeno Kraljevstvo

Xellia Pharmaceuticals ApS

Dalslandsgade 11, København S,

2300, Danska

Ova uputa je zadnji puta revidirana u

Drugi izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

lijekove: http://www.ema.europa.eu.

Sljedeće informacije namijenjene su samo liječnicima i zdravstvenim djelatnicima:

Upute kako rekonstituirati i razrijediti Caspofungin Accord:

Rekonstitucija lijeka Caspofungin Accord

NE KORISTITE OTAPALA KOJA SADRŽE GLUKOZU jer CASPOFUNGIN ACCORD nije

stabilan u otopinama koje sadrže glukozu. NEMOJTE MIJEŠATI NI DAVATI Caspofungin Accord

U INFUZIJI ISTODOBNO S DRUGIM LIJEKOVIMA jer nema podataka o kompatibilnosti lijeka

Caspofungin Accord s ostalim intravenskim pripravcima, aditivima ili lijekovima. Vizualno provjerite

infuzijsku otopinu da ne sadrži vidljive čestice ili da nije promijenila boju.

UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (Caspofungin Accord 50 mg)

Korak 1. Rekonstitucija uobičajenih bočica

Kako biste rekonstituirali prašak, zagrijte bočicu na sobnu temperaturu i u aseptičkim uvjetima dodajte

10,5 ml vode za injekciju. Koncentracija rekonstituirane otopine u bočici iznosit će 5,2 mg/ml.

Bijeli do bjelkasti kompaktni liofilizirani prašak potpuno će se otopiti. Lagano miješajte sve dok ne

dobijete bistru otopinu. Rekonstituiranu otopinu morate vizualno provjeriti da ne sadrži vidljive

čestice ili da nije promijenila boju. Rekonstituirana otopina može se čuvati do 24 sata pri temperaturi

od 25°C ili nižoj.

Korak 2. Dodavanje rekonstituiranog lijeka Caspofungin Accord u infuzijsku otopinu za

bolesnika

Otapala koja se moraju koristiti za pripremu konačne otopine za infuziju su: otopina natrijevog klorida

za injekcije od 9 mg/ml ili Ringerova otopina s laktatom. Otopina za infuziju priprema se dodavanjem

odgovarajuće količine rekonstituiranog koncentrata (kako je prikazano u donjoj tablici) u aseptičkim

uvjetima u infuzijsku vrećicu ili bocu od 250 ml. Može se koristiti i infuzija manjeg volumena od

100 ml, kad za to postoje medicinski razlozi, za primjenu dnevne doze od 50 mg ili 35 mg. Nemojte

koristiti otopinu koja je mutna ili sadrži talog.

PRIPREMA OTOPINE ZA INFUZIJU ZA ODRASLE (Caspofungin Accord 50 mg)

DOZA*

Volumen

rekonstituiranog

lijeka Caspofungin

Accord koji se dodaje

u vrećicu ili bocu za

intravensku infuziju

Standardna

priprema

(rekonstituirani

Caspofungin Accord

dodan u 250 ml

otopine) završna

koncentracija

Smanjeni volumen

infuzije

(rekonstituirani

Caspofungin Accord

dodan u 100 ml

otopine)

završna koncentracija

50 mg

10 ml

0,20 mg/ml

50 mg pri smanjenom

volumenu

10 ml

0,47 mg/ml

35 mg pri umjerenom

oštećenju funkcije jetre

(iz jedne bočice od 50 mg)

7 ml

0,14 mg/ml

35 mg pri umjerenom

oštećenju funkcije jetre

(iz jedne bočice od 50 mg)

pri smanjenom volumenu

7 ml

0,34 mg/ml

* Sve bočice moraju se rekonstituirati pomoću volumena od 10,5 ml.

UPUTE ZA UPORABU U ODRASLIH BOLESNIKA (Caspofungin Accord 70 mg)

Korak 1. Rekonstitucija uobičajenih bočica

Kako biste rekonstituirali prašak, zagrijte bočicu na sobnu temperaturu i u aseptičkim uvjetima dodajte

10,5 ml vode za injekciju. Koncentracija rekonstituirane otopine u bočici iznosit će 7,2 mg/ml.

Bijeli do bjelkasti kompaktni liofilizirani prašak potpuno će se otopiti. Lagano miješajte sve dok ne

dobijete bistru otopinu. Rekonstituiranu otopinu morate vizualno provjeriti da ne sadrži vidljive

čestice ili da nije promijenila boju. Rekonstituirana otopina može se čuvati do 24 sata pri temperaturi

od 25°C ili nižoj.

Korak 2. Dodavanje rekonstituiranog lijeka Caspofungin Accord u infuzijsku otopinu za

bolesnika

Otapala koja se moraju koristiti za pripremu konačne otopine za infuziju su: otopina natrijevog klorida

za injekcije od 9 mg/ml ili Ringerova otopina s laktatom. Otopina za infuziju priprema se dodavanjem

odgovarajuće količine rekonstituiranog koncentrata (kako je prikazano u donjoj tablici) u aseptičkim

uvjetima u infuzijsku vrećicu ili bocu od 250 ml. Može se koristiti i infuzija manjeg volumena od

100 ml, kad za to postoje medicinski razlozi, za primjenu dnevne doze od 50 mg ili 35 mg. Nemojte

koristiti otopinu koja je mutna ili sadrži talog.

PRIPREMA OTOPINE ZA INFUZIJU ZA ODRASLE

DOZA*

Volumen

rekonstituiranog

lijeka

Caspofungin

Accord koji se

dodaje u vrećicu

ili bocu za

intravensku

infuziju

Standardna

priprema

(rekonstituirani

Caspofungin Accord

dodan u 250 ml

otopine) završna

koncentracija

Smanjeni volumen

infuzije (rekonstituirani

Caspofungin Accord

dodan u 100 ml otopine)

završna koncentracija

70 mg

10 ml

0,28 mg/ml

Ne preporučuje se

70 mg

(iz dvije bočice od

50 mg)**

14 ml

0,28 mg/ml

Ne preporučuje se

35 mg pri umjerenom

oštećenju funkcije jetre

(iz jedne bočice od

70 mg)

5 ml

0,14 mg/ml

0,34 mg/ml

* Sve bočice moraju se rekonstituirati pomoću volumena od 10,5 ml.

**Ako bočica od 70 mg

nije

raspolaganju,

doza

70 mg može se pripremiti iz dvije bočice od

50 mg

UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (Caspofungin Accord 50 mg)

Izračun površine tijela (PT) za doziranje u pedijatrijskih bolesnika

Prije pripreme infuzije, izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule:

(Mostellerova

formula)

3600

(kg)

Težina

(cm)

Visina

Priprema doze od 70 mg/m

2

u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od

50 mg)

Odredite stvarnu udarnu dozu koja se mora primijeniti u pedijatrijskog bolesnika pomoću

površine tijela bolesnika (izračunate prema gornjoj formuli) i sljedeće jednadžbe:

PT (m

) × 70 mg/m

= udarna doza

Maksimalna udarna doza 1. dana ne smije biti viša od 70 mg bez obzira na veličinu izračunate

doze za bolesnika.

Ostavite ohlađenu bočicu lijeka Caspofungin Accord da postigne sobnu temperaturu.

Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17):1098 (letter)

U aseptičkim uvjetima dodajte 10,5 ml vode za injekciju

. Ovako rekonstituirana otopina može

se čuvati do 24 sata pri temperaturi 25°C ili nižoj.

Na ovaj ste način u bočici dobili završnu

koncentraciju kaspofungina od 5,2 mg/ml.

Izvucite iz bočice volumen lijeka jednak izračunatoj udarnoj dozi (Korak 1). U aseptičkim

uvjetima prenesite taj volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u vrećicu (ili

bocu) za i.v. primjenu koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog klorida za

infuziju ili Ringerovu otopinu s laktatom za infuziju. Alternativno možete dodati volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u smanjeni volumen 0,9%, 0,45% ili 0,225%

otopine natrijevog klorida za infuziju ili Ringerove otopine s laktatom za infuziju, s time da

završna koncentracija ne smije biti veća od 0,5 mg/ml. Ova se infuzijska otopina mora

primijeniti u roku od 24 sata ako se čuva pri temperaturi 25°C ili nižoj ili u roku od 48 sati ako

se čuva u hladnjaku pri temperaturi od 2°C do 8°C.

Priprema doze od 50 mg/m

2

u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od

50 mg)

Odredite stvarnu dnevnu dozu održavanja koja će se primjenjivati u pedijatrijskog bolesnika

koristeći površinu tijela bolesnika (izračunatu prema gornjoj formuli) i sljedeću jednadžbu:

PT (m

) × 50 mg/m

= dnevna doza održavanja

Dnevna doza održavanja ne smije biti veća od 70 mg bez obzira na veličinu izračunate doze za

bolesnika.

Ostavite ohlađenu bočicu lijeka Caspofungin Accord da postigne sobnu temperaturu.

U aseptičkim uvjetima dodajte 10,5 ml vode za injekciju.

Ovako rekonstituirana otopina može

se čuvati do 24 sata pri temperaturi 25°C ili nižoj.

Na ovaj ste način u bočici dobili završnu

koncentraciju kaspofungina od 5,2 mg/ml.

Izvucite iz bočice volumen lijeka jednak izračunatoj dnevnoj dozi održavanja (Korak 1). U

aseptičkim uvjetima prenesite taj volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u

vrećicu (ili bocu) za i.v. primjenu koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog

klorida za infuziju ili Ringerovu otopinu s laktatom za infuziju. Alternativno možete dodati

volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u smanjeni volumen 0,9%, 0,45% ili

0,225% otopine natrijevog klorida za infuziju ili Ringerove otopine s laktatom za infuziju, s

time da završna koncentracija ne smije biti veća od 0,5 mg/ml. Ova se infuzijska otopina mora

primijeniti u roku od 24 sata ako se čuva pri temperaturi 25°C ili nižoj ili u roku od 48 sati ako

se čuva u hladnjaku pri temperaturi od 2°C do 8°C.

Napomene za pripremu:

a. Bijeli do bjelkasti kompaktni prašak potpuno će se otopiti. Nježno miješajte sve dok otopina ne

postane potpuno bistra.

b. Vizualno provjerite rekonstituiranu otopinu kako biste utvrdili da ne sadrži vidljive čestice ili da

nije promijenila boju tijekom rekonstitucije i prije infuzije. Nemojte koristiti otopinu koja je mutna

ili sadrži talog.

c. Caspofungin Accord je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza

navedena na naljepnici bočice (50 mg).

UPUTE ZA UPORABU U PEDIJATRIJSKIH BOLESNIKA (Caspofungin Accord 70 mg)

Izračun površine tijela (PT) za doziranje u pedijatrijskih bolesnika

Prije pripreme infuzije izračunajte površinu tijela (PT) bolesnika pomoću sljedeće formule:

(Mostellerova

formula)

3600

(kg)

Težina

(cm)

Visina

Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17):1098 (letter)

Priprema doze od 70 mg/m

2

u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od

70 mg)

Odredite stvarnu udarnu dozu koja se mora primijeniti u pedijatrijskog bolesnika pomoću

površine tijela bolesnika (izračunate prema gornjoj formuli) i sljedeće jednadžbe:

PT (m

) × 70 mg/m

= udarna doza

Maksimalna udarna doza 1. dana ne smije biti viša od 70 mg bez obzira na veličinu izračunate

doze za bolesnika.

Ostavite ohlađenu bočicu lijeka Caspofungin Accord da postigne sobnu temperaturu.

U aseptičkim uvjetima dodajte 10,5 ml vode za injekciju

. Ovako rekonstituirana otopina može

se čuvati do 24 sata na temperaturi 25°C ili nižoj.

Na ovaj ste način u bočici dobili završnu

koncentraciju kaspofungina od 7,2 mg/ml.

Izvucite iz bočice volumen lijeka jednak izračunatoj udarnoj dozi (Korak 1). U aseptičkim

uvjetima prenesite taj volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u vrećicu (ili

bocu) za i.v. primjenu koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog klorida za

infuziju ili Ringerovu otopinu s laktatom za infuziju. Alternativno možete dodati volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u smanjeni volumen 0,9%, 0,45% ili 0,225%

otopine natrijevog klorida za infuziju ili Ringerove otopine s laktatom za infuziju, s time da

završna koncentracija ne smije biti veća od 0,5 mg/ml. Ova se infuzijska otopina mora

primijeniti u roku od 24 sata ako se čuva pri temperaturi 25°C ili nižoj ili u roku od 48 sati ako

se čuva u hladnjaku pri temperaturi od 2°C do 8°C.

Priprema doze od 50 mg/m

2

u infuziji za pedijatrijske bolesnike u dobi od >3 mjeseca (iz bočice od

70 mg)

Odredite stvarnu dnevnu dozu održavanja koja će se primjenjivati u pedijatrijskog bolesnika

koristeći površinu tijela bolesnika (izračunatu prema gornjoj formuli) i sljedeću jednadžbu:

PT (m

) × 50 mg/m

= dnevna doza održavanja

Dnevna doza održavanja ne smije biti veća od 70 mg bez obzira na veličinu izračunate doze za

bolesnika.

Ostavite ohlađenu bočicu lijeka Caspofungin Accord da postigne sobnu temperaturu.

U aseptičkim uvjetima dodajte 10,5 ml vode za injekciju.

Ovako rekonstituirana otopina može

se čuvati do 24 sata na temperaturi 25°C ili nižoj.

Na ovaj ste način u bočici dobili završnu

koncentraciju kaspofungina od 7,2 mg/ml.

Izvucite iz bočice volumen lijeka jednak izračunatoj dnevnoj dozi održavanja (Korak 1). U

aseptičkim uvjetima prenesite taj volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u

vrećicu (ili bocu) za i.v. primjenu koja sadrži 250 ml 0,9%, 0,45% ili 0,225% otopine natrijevog

klorida za infuziju ili Ringerovu otopinu s laktatom za infuziju. Alternativno možete dodati

volumen (ml)

rekonstituiranog lijeka Caspofungin Accord u smanjeni volumen 0,9%, 0,45% ili

0,225% otopine natrijevog klorida za infuziju ili Ringerove otopine s laktatom za infuziju, s

time da završna koncentracija ne smije biti veća od 0,5 mg/ml. Ova se infuzijska otopina mora

primijeniti u roku od 24 sata ako se čuva pri temperaturi 25°C ili nižoj ili u roku od 48 sati ako

se čuva u hladnjaku pri temperaturi od 2°C do 8°C.

Napomene za pripremu:

a. Bijeli do bjelkasti kompaktni prašak potpuno će se otopiti. Nježno miješajte sve dok otopina ne

postane potpuno bistra.

b. Vizualno provjerite rekonstituiranu otopinu kako biste utvrdili da ne sadrži vidljive čestice i da nije

promijenila boju tijekom rekonstitucije i prije infuzije. Nemojte koristiti otopinu koja je mutna ili

sadrži talog.

c. Caspofungin Accord je pripravljen tako da se izvlačenjem 10 ml iz bočice sigurno dobije puna doza

navedena na naljepnici bočice (70 mg).

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

29-8-2018

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Active substance: Ulipristal Acetate) - Centralised - Authorisation - Commission Decision (2018)5779 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/5017

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

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

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

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

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety