Venofer

Glavne informacije

  • Zaščiteno ime:
  • Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje
  • Farmacevtska oblika:
  • raztopina za injiciranje/infundiranje
  • Sestava:
  • železo 20 mg / 1 ml
  • Pot uporabe:
  • Intravenska uporaba
  • Enote v paketu:
  • škatla s 5 ampulami s 5 ml raztopine
  • Tip zastaranja:
  • ZZ - Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v javnih zdravstvenih zavodih ter pri pravn
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • Zdravila z železom za parenteralno uporabo

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1101-3/2014-12
  • Datum dovoljenje:
  • 12-06-2015
  • EAN koda:
  • 3837000072969
  • Zadnja posodobitev:
  • 26-05-2018

Podatki za bolnike

JAZMP-II/010-20.5.2016

NAVODILO ZA UPORABO

Venofer

20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje

ŽELEZO

Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo hitreje na voljo nove

informacije o njegovi varnosti. Tudi sami lahko k temu prispevate tako, da poročate o

katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti pri vas. Glejte na koncu

poglavja 4, kako poročati o neželenih učinkih.

Kaj vsebuje navodilo

1. Kaj je zdravilo Venofer in za kaj ga uporabljamo

2. Kaj morate vedeti, preden boste prejeli zdravilo Venofer

3. Kako se zdravilo Venofer daje

4. Možni neželeni učinki

5. Shranjevanje zdravila Venofer

6. Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo Venofer in za kaj ga uporabljamo

V zdravilu Venofer je železo, ki je vezano v večjedrni kompleks s saharozo. Kompleks je

dovolj velik, da se ne izloči skozi ledvice. V normalnih (fizioloških) pogojih je obstojen in

ne sprošča železovih ionov.

Zdravilo Venofer se uporablja za zdravljenje pomanjkanja železa:

pri klinični potrebi, ko je treba hitro napolniti zaloge železa v telesu,

pri bolnikih, ki slabo prenašajo zdravljenje s peroralnimi pripravki železa (to so

pripravki, ki se jih zaužije), ali ki odklanjajo zdravljenje,

kjer peroralni pripravki železa niso učinkoviti (npr. pri aktivni kronični vnetni

črevesni bolezni).

2. Kaj morate vedeti, preden boste prejeli zdravilo Venofer

Ne smete prejeti zdravila Venofer:

Pred začetkom uporabe zdravila, natančno preberite navodilo, ker vsebuje za vas

pomembne podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko

celo škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem

navodilu. Glejte poglavje 4.

JAZMP-II/010-20.5.2016

če ste alergični na zdravilno učinkovino ali katero koli sestavino tega zdravila

(navedeno v poglavju 6),

če ste imeli hudo alergijsko (preobčutljivostno) reakcijo na druga zdravila za

injiciranje, ki vsebujejo železo,

če imate zmanjšano koncentracijo rdečih krvnih celic in/ali koncentracijo

hemoglobina v krvi (anemijo), ki ni posledica pomanjkanja železa,

v primeru prevelike količine železa v telesu ali motenega vgrajevanja železa.

Opozorila in previdnostni ukrepi

Zdravnik vam bo predpisal zdravilo Venofer šele potem, ko bo preučil vaše izvide

laboratorijskh preiskav krvi.

Po parenteralnem dajanju pripravkov železa (to so pripravki, ki se dajejo v obliki

raztopine v žilo, kot je npr. injekcija ali infuzija) se lahko pojavijo alergijske ali

anafilaktoidne reakcije, ki so lahko usodne. Preden boste prejeli zdravilo Venofer, je

pomembno, da se posvetujete z zdravnikom ali medicinsko sestro:

če ste v preteklosti že imeli alergijske reakcije,

če imate sistemski eritematozni lupus,

če imate revmatoidni artritis,

če imate hudo astmo, ekcem ali drugo atopično alergijo.

Svojega zdravnika prav tako opozorite, če imate:

motnjo v delovanju jeter,

akutno ali kronično okužbo, ker lahko parenteralno dano železo poslabša bakterijsko

ali virusno okužbo.

Druga zdravila in zdravilo Venofer

Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati

katero koli drugo zdravilo.

Injekcije oziroma infuzije zdravila Venofer ne smete prejeti sočasno s pripravki železa, ki

jih lahko zaužijete (peroralnimi pripravki železa), saj se zmanjša prehajanje zaužitega

železa iz črevesja v kri. Jemanje peroralnih železovih pripravkov vam bo zdravnik

predpisal vsaj 5 dni po zadnji prejeti injekciji železa.

Nosečnost, dojenje in plodnost

Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z

zdravnikom, preden prejmete to zdravilo.

Zdravilo Venofer ni bilo preskušeno pri nosečnicah. Če med zdravljenjem zanosite, se

morate za nasvet obrniti na svojega zdravnika. Zdravnik bo presodil, ali zdravilo smete

prejeti.

Podatki iz omejenega števila preučevanih nosečnosti pri ljudeh niso pokazali neželenih

učinkov železovega saharata na nosečnost ali na zdravje zarodka/novorojenca.

Vendar pa je potrebna ocena tveganja v primerjavi s koristjo.

Če dojite, se posvetujte z zdravnikom, preden vam dajo zdravilo Venofer.

Vpliv na sposobnost upravljanja vozil in strojev

JAZMP-II/010-20.5.2016

Verjetnost, da bi zdravilo Venofer vplivalo na sposobnost upravljanja vozil in strojev, je

zelo majhna.

3. Kako se zdravilo Venofer daje

Načini dajanja zdravila Venofer

Zdravnik ali medicinska sestra vam bosta dala zdravilo Venofer intravensko (v veno) s

kapalno infuzijo, počasno intravensko injekcijo ali neposredno v venski kateter

dializnega aparata. Zdravilo Venofer vam bodo dali v okolju, kjer je mogoče ustrezno in

hitro zdraviti imunoalergijske reakcije. Po vsakem injiciranju vas bosta zdravnik ali

medicinska sestra opazovala še 30 minut.

Zdravilo Venofer ni primerno za injiciranje v mišico (intramuskularno uporabo).

Odmerjanje zdravila Venofer

Odmerek zdravila Venofer bo zdravnik prilagodil vsakemu posameznemu bolniku, glede

na celotno pomanjkanje železa v telesu, ki ga bo izračunal po določenem obrazcu. Če

skupni potrebni odmerek presega največji dovoljeni enkratni odmerek, ga je treba

razdeliti. Podrobne informacije o načinu dajanja in odmerjanju zdravila Venofer boste

našli v poglavju »Naslednje informacije so namenjene samo zdravstvenemu osebju«.

Uporaba pri odraslih in starejših

Običajni odmerek je 5–10 ml zdravila Venofer (100–200 mg železa) enkrat do trikrat na

teden, odvisno od izvidov laboratorijskih preiskav krvi. Največji dnevni odmerek, ki ga

bolnik lahko še prenese:

v obliki injekcije: 10 ml zdravila Venofer (200 mg železa), ki se injicira najmanj 10

minut.

v obliki infuzije: 7 mg železa na kilogram telesne mase, ki se ga daje enkrat na teden,

vendar odmerek ne presega 500 mg železa.

Uporaba pri otrocih

O otrocih, ki so sodelovali v raziskavi, je le malo podatkov. Če obstaja klinična potreba,

je priporočljivi odmerek največ 0,15 ml zdravila Venofer (3 mg železa) na kilogram

telesne mase, enkrat do trikrat na teden, odvisno od izvidov laboratorijskih preiskav krvi.

Če ste prejeli večji odmerek zdravila Venofer, kot bi smeli

Ker vam bo zdravilo Venofer dalo zdravstveno osebje, je verjetnost, da bi prejeli prevelik

odmerek tega zdravila, majhna. Če vas skrbi, da ste prejeli prevelik odmerek zdravila

Venofer, se takoj posvetujte z zdravnikom ali zdravstvenim osebjem. Preveliko

odmerjanje pripravkov železa lahko povzroči nenadno preobremenitev z železom, kar se

lahko odraža kot kopičenje železa v tkivih in organih (hemosideroza).

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali

farmacevtom.

4. Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh

bolnikih.

JAZMP-II/010-20.5.2016

Najpogostejši neželeni učinki zdravila Venofer v kliničnih poskusih so bili: prehodna

sprememba okusa, nizek krvni tlak, vročina in tresenje, reakcije na mestu injiciranja in

slabost, ki so se pojavili pri 0,5 do 1,5 % bolnikov. Blage anafilaktoidne reakcije so bile

redke.

Na splošno so anafilaktoidne reakcije potencialno najhujši neželeni učinki (glejte

poglavje »Bodite posebno pozorni pri uporabi zdravila Venofer«).

Poročali so o naslednjih neželenih učinkih:

Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):

prehodne spremembe okusa (zlasti kovinski okus)

Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):

glavobol, vrtoglavica

nizek krvni tlak (hipotenzija) in kolaps, povečan srčni utrip (tahikardija), hitro in močno

utripanje srca (palpitacije)

krči bronhijev (bronhospazem), oteženo dihanje (dispneja)

slabost, bruhanje, bolečine v želodcu, driska

srbečica (pruritus), koprivnica, kožni izpuščaj, prišč (eksantem), rdečina (eritem)

mišični krči, bolečine v mišicah

vročina, tresenje, rdečica, bolečine v prsih ter tesnoba; motnje na mestu injiciranja,

kot so vnetje ven (površinski flebitis), pekoč občutek in oteklina

Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):

mravljinčenje (parestezija)

anafilaktoidne reakcije (ki redko zajemajo bolečine v sklepih), otekanje okončin

(periferni edem), utrujenost, nemoč (astenija), slabo počutje

Izkušnje po prihodu zdravila na tržišče

Poleg naštetih neželenih učinkov, so tudi spontana poročanja o naslednjih neželenih

pojavih.

Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):

zmanjšana stopnja zavesti, občutek vrtoglavice, zmedenost; oteklina kože ali sluznic

(angioedem) ter otekanje sklepov

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko

sestro. Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni

v tem navodilu. O neželenih učinkih lahko poročate tudi neposredno na nacionalni center

za poročanje: Univerzitetni klinični center Ljubljana, Interna klinika, Center za

zastrupitve, Zaloška cesta 2, SI-1000 Ljubljana, faks: + 386 (0)1 434 76 46, e-pošta:

farmakovigilanca@kclj.si. S tem, ko poročate o neželenih učinkih, lahko prispevate k

zagotoviti več informacij o varnosti tega zdravila.

5. Shranjevanje zdravila Venofer

Zdravilo shranjujte nedosegljivo otrokom!

JAZMP-II/010-20.5.2016

Shranjujte v originalni ovojnini.

Shranjujte pri temperaturi do 25

Ne zamrzujte.

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na

škatli poleg oznake »EXP:«. Rok uporabnosti se izteče na zadnji dan navedenega

meseca.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu

odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki

ukrepi pomagajo varovati okolje.

6. Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Venofer

Zdravilna učinkovina je železo.

1 ml raztopine za injiciranje/koncentrata za raztopino za infundiranje vsebuje 20 mg

železa v obliki železovega (III) oksid saharata.

5 ml raztopine za injiciranje/koncentrata za raztopino za infundiranje (1 ampula)

vsebuje 100 mg železa v obliki železovega (III) oksid saharata.

Druge sestavine zdravila (pomožne snovi) so: natrijev hidroksid (za uravnavanje pH),

voda za injekcije.

Izgled zdravila Venofer in vsebina pakiranja

Raztopina za injiciranje/koncentrat za raztopino za infundiranje je temno rjava,

neprozorna vodna raztopina, katere pH je 10,5-11,0 in osmolarnost 1250 mOsmol/l.

Zdravilo je na voljo v škatli s 5 ampulami po 5 ml raztopine za injiciranje/koncentrata za

raztopino za infundiranje.

Način in režim izdaje zdravila Venofer

ZZ - Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v

javnih zdravstvenih zavodih ter pri pravnih in fizičnih osebah, ki opravljajo zdravstveno

dejavnost.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Lek farmacevtska družba d.d., Verovškova 57, 1526 Ljubljana, Slovenija

Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika

dovoljenja za promet z zdravilom.

Navodilo je bilo nazadnje revidirano 20.5.2016.

Naslednje informacije so namenjene samo zdravstvenemu osebju:

Med injiciranjem zdravila Venofer in po njem bolnike pazljivo spremljajte za znake in

simptome preobčutljivostnih reakcij.

JAZMP-II/010-20.5.2016

Zdravilo Venofer se lahko uporablja le, če je takoj na voljo osebje, ki je usposobljeno za

prepoznavanje anafilaktičnih reakcij in zna ustrezno ukrepati v okolju, kjer je

zagotovljena vsa oprema za oživljanje. Zaradi morebitnega pojava neželenih učinkov je

treba bolnika opazovati vsaj 30 minut po injiciranju zdravila Venofer.

Zdravilo Venofer dajemo le intravensko s kapalno infuzijo, počasno intravensko injekcijo

ali neposredno v venski kateter dializnega aparata. Zdravilo Venofer ni primerno za

intramuskularno uporabo in za vensko infuzijo celotnega odmerka (TDI), kjer bolnik

prejme celotno potrebno količino železa, ki pomeni celotno pomanjkanje železa pri

bolniku.

Pri prehitrem injiciranju zdravila Venofer se lahko pojavi hipotenzija.

Pri injiciranju zdravila Venofer pazimo, da se ne izlije v okolico vene, ker lahko povzroči

nekrozo tkiva in rjavo obarvanost kože na mestu injiciranja. Če se zaradi nepazljivosti

zdravilo Venofer izlije v okolico vene, lahko pomaga naslednje: lokalno na mesto

injiciranja nanesemo heparin gel ali mazilo, da kar najbolj pospešimo izločanje železa in

preprečimo njegovo širitev. Gel oziroma mazilo nanašamo previdno, brez masiranja.

Zdravilo Venofer lahko mešate le z 0,9 % m/V raztopino NaCl. Uporabiti ne smete

nobenih drugih intravenskih raztopin za redčenje in zdravil, ker lahko nastane usedlina

in/ali medsebojno učinkovanje. Kompatibilnost z drugimi vsebniki razen iz stekla,

polietilena in PVC ni znana.

Pred uporabo je treba ampule vizualno pregledati zaradi usedlin in poškodb. Uporabljati

se smejo le ampule, ki ne vsebujejo usedlin in v katerih je homogena raztopina.

Uporabnost zdravila Venofer po odprtju ampule:

Z mikrobiološkega stališča je treba zdravilo porabiti takoj.

Uporabnost zdravila Venofer po redčenju z 0,9 % m/V raztopino natrijevega

klorida:

Kemijska in fizikalna obstojnost v času uporabe je bila dokazana v obdobju 12 ur pri

sobni temperaturi. Z mikrobiološkega stališča je treba zdravilo porabiti takoj. Če ga ne

porabite takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja pred

uporabo, odgovoren uporabnik. Navadno niso daljši od 3 ur pri sobni temperaturi, razen

če je redčenje potekalo v nadzorovanih in validiranih aseptičnih pogojih.

Infuzija: Priporočamo, da zdravilo Venofer dajete predvsem kot kapalno infuzijo (da se

zmanjša nevarnost hipotenzivnih epizod in injiciranja ob veno). 1 ml zdravila Venofer (20

mg železa) razredčite v največ 20 ml 0,9 % raztopine natrijevega klorida m/V [5 ml (100

mg železa) v največ 100 ml 0,9 % NaCl m/V itd. do največ 25 ml (500 mg železa) v

največ 500 ml 0,9 % NaCl m/V]. Redčenje opravite neposredno pred infuzijo, raztopino

pa dajajte kot sledi: 100 mg železa vsaj 15 minut; 200 mg železa vsaj 30 minut; 300 mg

železa vsaj 1 ½ ure; 400 mg železa vsaj 2 ½ ure in 500 mg železa vsaj 3 ½ ure. Za

dajanje največjega enkratnega dovoljenega odmerka 7 mg železa/kg telesne mase je

treba upoštevati čas infuzije najmanj 3 ½ ure ne glede na celotni odmerek.

Intravenska injekcija: Zdravilo Venofer lahko dajemo tudi nerazredčeno s počasno

intravensko injekcijo z (običajno) priporočeno hitrostjo 1 ml zdravila Venofer (20 mg

železa) na minuto [5 ml zdravila Venofer (100 mg železa) najmanj 5 minut]. Naenkrat

lahko vbrizgamo največ 10 ml zdravila Venofer (200 mg železa) v intravenski injekciji.

JAZMP-II/010-20.5.2016

Injekcija v dializni aparat: Zdravilo Venofer lahko dajemo neposredno v venski kateter

dializnega aparata na enak način kot intravensko injekcijo.

Odmerjanje zdravila Venofer

Izračun odmerkov:

Zdravilo Venofer odmerjamo individualno glede na celotno pomanjkanje železa v telesu,

ki ga izračunamo po naslednjem obrazcu:

celotna količina železa, ki naj jo bolnik prejme [mg] = telesna masa [kg] x (želena

koncentracija Hb – določena koncentracija Hb) [g/l] x 0,24* + količina železa za

zapolnitev zalog [mg]

Do 35 kg telesne mase: želena koncentracija Hb = 130 g/l oziroma količina železa za

zapolnitev zalog = 15 mg/kg telesne mase

Nad 35 kg telesne mase: želena koncentracija Hb = 150 g/l oziroma količina železa za

zapolnitev zalog = 500 mg

* Dejavnik 0,24 = 0,0034 x 0,07 x 1000 (količina železa v hemoglobinu

0,34 % /

volumen krvi

7 % telesne mase / dejavnik 1000 = preračunanje g v mg)

Celotna količina zdravila Venofer, ki naj jo bolnik prejme (v ml) = celotna količina železa,

bolnik

prejme

[mg]

20 mg/ml

(1 ampula zdravila Venofer je enakovredna 5 ml)

Telesna

masa [kg]

Skupno število ampul zdravila Venofer, ki naj jih bolnik prejme

Hb 60 g/l

Hb 75 g/l

Hb 90 g/l

Hb 105 g/l

12,5

11,5

13,5

11,5

10,5

13,5

11,5

16,5

14,5

17,5

12,5

18,5

22,5

19,5

16,5

13,5

23,5

20,5

24,5

21,5

14,5

JAZMP-II/010-20.5.2016

Če skupni potrebni odmerek presega največji dovoljeni enkratni odmerek, ga je treba

razdeliti. Če se po 1 do 2 tednih zdravljenja hematološki parametri ne izboljšajo, je treba

ponovno preveriti prvotno diagnozo.

Izračun količine železa, ki naj jo bolnik prejme po krvavitvi in po avtotransfuziji:

Potrebni odmerek zdravila Venofer, ki nadomesti pomanjkanje železa, izračunamo po

spodnjih obrazcih:

če je znana količina izgubljene krvi: po intravenskem dajanju 200 mg železa (= 10

ml zdravila Venofer) se koncentracija hemoglobina zveča enako, kot če bi bolniku

dali 1 enoto krvi (= 400 ml s koncentracijo hemoglobina 150 g/l).

Količina železa [mg], ki naj jo bolnik prejme = število enot izgubljene krvi x 200, ali

Količina zdravila Venofer (ml), ki naj jo bolnik prejme = število enot izgubljene krvi x

če je količina Hb manjša: uporabimo prejšnji obrazec, le da ne upoštevamo

nadomestitve zalog železa v telesu.

Količina železa [mg], ki naj jo bolnik prejme = telesna masa [kg] x 0,24 x (želena

koncentracija hemoglobina – določena koncentracija hemoglobina) [g/l]

Na primer: telesna masa 60 kg, pomanjkanje hemoglobina = 10 g/l

količina

železa, ki jo moramo nadomestiti

150 mg

7,5 ml zdravila Venofer.

Običajno odmerjanje:

Odrasli in starejši ljudje:

5–10 ml zdravila Venofer (100–200 mg železa) enkrat do trikrat na teden, odvisno od

koncentracije hemoglobina.

Otroci:

O otrocih, ki so sodelovali v raziskavi, je le malo podatkov. Če obstaja klinična

potreba, priporočamo, da ne prekoračite 0,15 ml zdravila Venofer (3 mg železa) na

kilogram telesne mase enkrat do trikrat na teden, odvisno od koncentracije

hemoglobina.

Največji enkratni odmerek, ki ga bolnik še lahko prenese:

Odrasli in starejši ljudje:

V obliki injekcije: 10 ml zdravila Venofer (200 mg železa), ki ga injiciramo najmanj 10

minut.

V obliki infuzije: Kadar je to zahtevalo klinično stanje, smo dajali odmerke do 500 mg.

Največji enkratni odmerek, ki ga bolnik še lahko prenese, je 7 mg železa na kilogram

telesne mase, ki ga dajemo enkrat na teden, vendar največ do 500 mg železa. Kar

zadeva čas odmerjanja in hitrost redčenja, glejte poglavje Načini dajanja zdravila

Venofer.

Večja pogostnost neželenih učinkov (zlasti hipotenzije), ki so lahko tudi hujši, je

povezana z večjimi odmerki. Zato je treba strogo upoštevati čase infuzije, prikazane

v poglavju Načini dajanja zdravila Venofer, četudi bolnik ne prejema največjega

dovoljenega enkratnega odmerka.

JAZMP-II/010-20.5.2016

Pri prevelikem odmerjanju je treba izvesti vse simptomatske ukrepe in po potrebi

uporabiti sredstvo, s katerim železo tvori kelate.

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

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the "Winning on Reducing Food Waste" initiative.

FDA - U.S. Food and Drug Administration

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

8-10-2018

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

2-10-2018

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

"The environment has a real impact on the risk of cancer, although it remains difficult to assess": three questions for Professor Gérard Lasfargues, Managing Director General of the Science for Expertise Division

Despite medical advances, cancer remains the leading cause of death in France.  While active smoking, alcohol consumption and an unbalanced diet continue to be the main causes of cancer mortality, the environment has a real impact on the risk of cancer, although it remains difficult to assess.

France - Agence Nationale du Médicament Vétérinaire

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.

France - Agence Nationale du Médicament Vétérinaire

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as 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

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

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

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

14-8-2018

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

The flashlights are missing an encapsulation on the circuit board component which could allow the flashlight to ignite in an explosive environment, posing a burn hazard and risk of personal injury to the user or bystander.

Health Canada

6-7-2018

Revocation of S-classification status for certain
medicinal products: lists

Revocation of S-classification status for certain medicinal products: lists

The Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status of medicinal products that have also been used outside the hospital  environment as well as for products which are now not considered to be limited to hospital use.

IMA - Icelandic Medicines Agency

30-5-2018

Climate change and health

Climate change and health

Climate change is a reality on which there is broad consensus in the scientific community. Because of the inertia of the climate system, changes to the climate related to human activities will continue for many years, regardless of any measures taken today. Combating climate change, which is part of a more global environmental change, is therefore essential to limit its magnitude.

France - Agence Nationale du Médicament Vétérinaire

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency