iroprem

Glavne informacije

  • Zaščiteno ime:
  • iroprem 50 mg/ml raztopina za injiciranje ali infundiranje
  • Farmacevtska oblika:
  • raztopina za injiciranje/infundiranje
  • Sestava:
  • železo 50 mg / 1 ml
  • Pot uporabe:
  • Intravenska uporaba
  • Enote v paketu:
  • škatla z 1 vialo z 10 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:
  • iroprem 50 mg/ml raztopina za injiciranje ali 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:
  • 10123-404/2016-4
  • Datum dovoljenje:
  • 28-02-2017
  • EAN koda:
  • 3837000054699
  • Zadnja posodobitev:
  • 26-05-2018

Podatki za bolnike

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Navodilo za uporabo

Iroprem

50 mg/ml raztopina za injiciranje ali 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.

Pred

začetkom jemanja 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.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom. Posvetujte se tudi, če opazite

katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Iroprem in za kaj ga uporabljamo

Kaj morate vedeti, preden boste prejeli zdravilo Iroprem

Kako se daje zdravilo Iroprem

Možni neželeni učinki

Shranjevanje zdravila Iroprem

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Iroprem in za kaj ga uporabljamo

Zdravilo Iroprem je pripravek proti slabokrvnosti, zdravilo, ki se uporablja za zdravljenje anemije.

Vsebuje železo, vezano na ogljikov hidrat. Železo je bistven element, ki omogoča, da hemoglobin v

rdečih krvničkah in mioglobin v mišičnem tkivu prenaša kisik. Poleg tega je železo vključeno v

številne druge funkcije v človeškem telesu, potrebne za vzdrževanje življenja.

Zdravilo Iroprem se uporablja za zdravljenje bolnikov s pomanjkanjem železa, kadar so peroralni

pripravki železa neučinkoviti ali jih ni mogoče uporabiti. Cilj zdravljenja je dopolniti telesne zaloge

železa in ozdraviti slabokrvnost, t.j. pomanjkanje rdečih krvničk zaradi pomanjkanja železa.

Pred uporabo zdravila vam bo zdravnik naredil preiskavo krvi, da bo lahko določil odmerek zdravila

Iroprem, ki ga potrebujete.

2.

Kaj morate vedeti, preden boste prejeli zdravilo Iroprem

Zdravila Iroprem ne smete prejeti

če ste alergični na zdravilo učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju

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

vsebujejo železo,

če imate anemijo, ki je

ne

povzroča pomanjkanje železa,

če ste preobremenjeni z železom (imate v telesu preveč železa) ali imate motnje izrabe železa.

Opozorila in previdnostni ukrepi

Preden boste prejeli zdravilo Iroprem se posvetujte z zdravnikom ali medicinsko sestro:

če ste v preteklosti že imeli alergijske reakcije,

če imate sistemski eritematozni lupus,

če imate revmatoidni artritis,

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če imate hudo astmo, ekcem ali drugo atopično alergijo,

če imate okužbo,

če imate bolezen jeter.

Zdravila Iroprem ni dovoljeno dajati otrokom, mlajšim od 14 let.

Nepravilno dajanje zdravila Iroprem lahko povzroči uhajanje zdravila na mestu vboda, kar lahko

povzroči iritacijo kože in potencialno dolgotrajno rjavkasto obarvanje na mestu vboda. Če se to zgodi,

je dajanje treba takoj ustaviti.

Kako se daje zdravilo Iroprem

Zdravnik ali medicinska sestra vam bosta dala zdravilo Iroprem nerazredčeno z injekcijo, med dializo

ali razredčeno z infuzijo; zdravilo Iroprem vam bodo dali v okolju, kjer je mogoče ustrezno in hitro

zdraviti imunoalergijske dogodke.

Po vsakem injiciranju vas bo zdravnik ali medicinska sestra opazovala vsaj še 30 minut

Druga zdravila in zdravilo Iroprem

Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati

katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.

Če se zdravilo Iroprem daje skupaj s peroralnimi pripravki železa, bodo ti peroralni pripravki mogoče

manj učinkoviti.

Nosečnost

Na voljo so omejeni podatki o uporabi zdravila Iroprem pri nosečnicah. Če ste noseči, menite, da bi

lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom. Če med zdravljenjem zanosite,

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

Dojenje

Če dojite, se posvetujte z zdravnikom preden vam dajo zdravilo Iroprem. Ni verjetno, da bi zdravilo

Iroprem predstavljalo nevarnost za dojenega otroka.

Vpliv na sposobnost upravljanja vozil in strojev

Ni verjetno, da bi zdravilo Iroprem zmanjšalo sposobnost upravljanja vozil in strojev.

Pomembne informacije o nekaterih sestavinah zdravila Iroprem

To zdravilo vsebuje 0,24 mmola (ali 5,5 mg) natrija na mililiter nerazredčene raztopine. To morajo

upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.

3.

Kako se daje zdravilo Iroprem

Za dajanje zdravila Iroprem ima zdravnik na voljo tri možne načine: nerazredčeno z injekcijo, med

dializo ali razredčeno z infuzijo.

Z injekcijo lahko prejmete do 20 ml zdravila Iroprem, kar ustreza 1.000 mg železa, enkrat tedensko

neposredno v veno.

Če ste na dializi, lahko prejmete zdravilo Iroprem med postopkom hemodialize preko dializnega

aparata.

V infuziji lahko prejmete do 20 ml zdravila Iroprem, kar ustreza 1.000 mg železa, enkrat na teden

neposredno v veno. Ker je zdravilo Iroprem za infuzijo razredčeno z raztopino natrijevega klorida,

ima lahko volumen do 250 ml in je na pogled rjava raztopina.

Če ste prejeli večji odmerek zdravila Iroprem, kot bi smeli

Za določitev primernega odmerka in izbire načina, pogostnosti in trajanja vašega zdravljenja bo

odgovoren vaš zdravnik.

Preveliko odmerjanje lahko povzroči kopičenje železa v telesnih zalogah. Zdravnik bo pri vas spremljal

parametre železa, kakršna sta serumski feritin in transferin, da bi preprečil kopičenje železa.

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4.

Možni neželeni učinki

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

Resni neželeni učinki

Takoj obvestite zdravnika, če doživite katerega od naslednjih znakov ali simptomov, ki lahko

pomenijo resno alergijsko reakcijo: izpuščaj (npr. koprivnico), srbenje, težave z dihanjem, piskanje

in/ali otekanje ustnic, jezika, grla ali telesa.

Pri nekaterih bolnikih te alergijske reakcije (pojavijo se lahko pri največ 1 od 1.000 bolnikov) lahko

postanejo hude ali življenjsko nevarne (znane kot anafilaktoidne reakcije) in so lahko povezane s

težavami srca in obtočil ter izgubo zavesti.

Zdravnik morebitne neželene učinke pozna in vas bo med aplikacijo zdravila Iroprem in po njej

nadzoroval.

Drugi neželeni učinki, o katerih morate obvestiti zdravnika, če postanejo resni:

Pogosti neželeni učinki

(pojavijo se lahko pri največ 1 od 10 bolnikov): glavobol, omotica, vročinski

oblivi (zardevanje), visok krvni tlak, slabost in reakcije na mestu injiciranja/infundiranja (glejte tudi

poglavje 2).

Občasni neželeni učinki

(pojavijo se lahko pri največ 1 od 100 bolnikov): občutek odrevenelosti,

mravljinčenja ali zbadanja na koži, motnje okušanja, hiter srčni utrip, nizek krvni tlak, težave z

dihanjem, bruhanje, prebavne težave, želodčne bolečine, zaprtje, driska, srbenje, koprivnica, pordelost

kože, izpuščaj, bolečine v mišicah, sklepih in/ali hrbtu, bolečina v rokah ali nogah, mišični krči,

povišana telesna temperatura, utrujenost, bolečine v prsih, otekanje dlani in/ali stopal ter mrzlica.

Redki neželeni učinki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov): vnetje vene, splošno slabo

počutje, izguba zavesti, tesnoba, omedlevica, omotičnost, sopenje, vetrovi (flatulenca), hitro otekanje

obraza, ust, jezika ali grla, zaradi česar je lahko dihanje oteženo, bledica, otekanje obraza, simptomi,

podobni gripi, npr. vročina, glavobol in/ali slabo počutje (influenci podobna bolezen).

Lahko se začasno spremenijo nekateri parametri krvi, kar je mogoče odkriti z laboratorijskimi

preiskavami.

Pogosta je naslednja sprememba parametrov krvi so pogoste: znižanje fosforja v krvi.

Naslednje spremembe parametrov krvi so občasne: zvišanje vrednosti nekaterih jetrnih encimov, na

primer alanin-aminotrasferaze, aspartat-aminotransferaze, gama-glutamiltransferaze in alkalne

fosfataze, in zvišanje vrednosti encima, ki se imenuje laktat-dehidrogenaza.

Za dodatne informacije se obrnite na svojega zdravnika.

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, 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 neposredno na

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke

Sektor za farmakovigilanco

Nacionalni center za farmakovigilanco

Slovenčeva ulica 22

SI-1000 Ljubljana

Tel: +386 (0)8 2000 500

Faks: +386 (0)8 2000 510

e-pošta: h-farmakovigilanca@jazmp.si

spletna stran: www.jazmp.si

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S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotoviti več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila Iroprem

Zdravilo Iroprem shranjujte nedosegljivo otrokom!

Zdravila Iroprem ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.

Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo. Shranjujte pri temperaturi do

C. Ne zamrzujte.

Ko je viala zdravila Iroprem odprta, jo je treba uporabiti takoj. Po razredčenju z raztopino natrijevega

klorida je treba razredčeno raztopino uporabiti takoj.

Zdravilo Iroprem bo navadno shranil za vas vaš zdravnik ali bolnišnica.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Iroprem

Zdravilna učinkovina je železo (v obliki ferikarboksimaltoze, ki je ogljikohidratna spojina železa).

Koncentracija železa v zdravilu je 50 mg na mililiter. Pomožne snovi so natrijev hidroksid (za

uravnavo pH), klorovodikova kislina (za uravnavo pH) in voda za injekcije.

Izgled zdravila Iroprem in vsebina pakiranja

Iroprem je temnorjava, netransparentna raztopina za injiciranje ali infundiranje.

Iroprem je dobavljen v steklenih vialah, ki vsebujejo

2 ml raztopine, kar ustreza 100 mg železa. Na voljo v velikostih pakiranj po 1, 2 in 5 vial.

10 ml raztopine, kar ustreza 500 mg železa. Na voljo v velikostih pakiranj po 1, 2 in 5 vial.

20 ml raztopine, kar ustreza 1000 mg železa. Na voljo v velikosti pakiranja po 1 vialo.

Na trgu morda ni vseh navedenih pakiranj.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Vifor France

100-101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

Francija

Tel. +33 (0)1 41 06 58 90

Fax +33 (0)1 41 06 58 99

Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:

Avstrija, Bolgarija, Hrvaška, Ciper, Češka republika, Danska, Estonija, Finska, Francija, Grčija,

Hrvaška, Irska, Islandija, Italija, Latvija, Litva, Madžarska, Malta, Nemčija, Nizozemska, Norveška,

Poljska, Portugalska, Romunija, Slovaška republika, Španija, Švedska, Velika Britanija: Ferinject

Belgija, Luksemburg: Injectafer

Slovenija: Iroprem

Način in režim izdajanja zdravila

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.

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Navodilo je bilo odobreno 29.03.2017.

Če potrebujete kakršne koli informacije o tem zdravilu, se obrnite na lokalnega predstavnika imetnika

dovoljenja za promet z zdravilom.

Lek farmacevtska družba d. d.,

Verovškova 57, 1526 Ljubljana,

Slovenija

Naslednje informacije so namenjene samo zdravstvenemu osebju:

Med vsakim injiciranjem zdravila Iroprem in po njem bolnike pazljivo spremljajte za znake in

simptome preobčutljivostnih reakcij. Zdravilo Iroprem 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 vsakem dajanju zdravila Iroprem.

Določanje potrebe po železu

Individualno potrebo po železu za zapolnitev z železom z uporabo zdravila Iroprem določimo na

podlagi bolnikove telesne mase in ravni hemoglobina (Hb) (glejte Tabelo 1):

Tabela 1:

Določanje potrebe po železu

Hb

Bolnikova telesna teža

g/dl

mmol/l

pod 35 kg

35 kg do < 70 kg

70 kg in več

< 10

< 6,2

500 mg

1.500 mg

2.000 mg

10 do < 14

6,2 do < 8,7

500 mg

1.000 mg

1.500 mg

≥ 14

≥ 8,7

500 mg

500 mg

500 mg

Pomanjkanje železa je treba potrditi z laboratorijskimi testi.

Izračun in dajanje največjega individualnega odmerka (odmerkov) železa

Na podlagi potrebe po železu, določene zgoraj, se ustrezni odmerek (odmerki) zdravila Iroprem

uporabi(jo) z upoštevanjem sledečega:

Enkratni odmerek zdravila Iroprem ne sme preseči:

15 mg železa/kg telesne teže (za intravensko injiciranje) ali 20 mg železa/kg telesne teže (za

intravensko infundiranje)

1.000 mg železa (20 ml zdravila Iroprem)

Največji priporočeni kumulativni odmerek je 1.000 mg železa (20 ml zdravila Iroprem) na teden.

Pri bolnikih s kronično ledvično boleznijo, ki so odvisni od hemodialize, se ne sme prekoračiti

največji dnevni injekcijski odmerek 200 mg železa.

Pri otrocih uporabe zdravila Iroprem niso raziskovali, zato pri otrocih, mlajših od 14 let, uporaba

zdravila Iroprem ni priporočljiva.

Način uporabe

Zdravilo Iroprem smemo dajati samo po intravenski poti: z injekcijo, infuzijo, ali

med hemodializo, ko dajemo nerazredčeno zdravilo neposredno v venski krak dializatorja. Zdravila

Iroprem ni dovoljeno uporabljati po subkutani ali intramuskularni poti.

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Pri dajanju zdravila moramo biti previdni, da se izognemo paravenskemu izlivu zdravila Iroprem.

Paravenski izliv zdravila Iroprem na mestu injiciranja lahko povzroči draženje kože in potencialno

dolgotrajno rjavo obarvanje kože na mestu injiciranja. V primeru paravenskega izliva moramo dajanje

zdravila Iroprem nemudoma prekiniti.

Intravenska injekcija

Zdravilo Iroprem lahko apliciramo v obliki intravenske injekcije z nerazredčeno raztopino. Največji

posamični odmerek je 15 mg železa/kg telesne teže, vendar ne sme preseči 1.000 mg železa. Čas

aplikacije je prikazan v Tabeli 2:

Tabela 2:

Čas aplikacije za intravensko injiciranje zdravila Iroprem

Potrebna količina

zdravila Iroprem

Enakovredni odmerek železa

Čas aplikacije/najkrajši čas

dajanja zdravila

4 ml

200 mg

Najkrajši čas ni določen

> 4

10 ml

> 200

500 mg

100 mg železa/min

> 10

20 ml

> 500

1.000 mg

15 minut

Intravenska infuzija

Zdravilo Iroprem se lahko uporablja za intravensko infundiranje, v tem primeru mora biti razredčeno.

Največji posamični odmerek je 20 mg železa/kg telesne teže, vendar ne sme preseči 1.000 mg železa.

V primeru infuzije smemo zdravilo Iroprem razredčiti le s sterilno 0,9-odstotno (m/v) raztopino

natrijevega klorida, kot je prikazano v Tabela 3. Opozorilo: razredčitve do koncentracij, nižjih od 2 mg

železa/ml, zaradi stabilnosti niso dovoljene (kar ne vključuje količine raztopine železove

karboksimaltoze).

Tabela 3:

Razredčenje zdravila Iroprem za intravensko infundiranje

Potrebna količina

zdravila Iroprem

Enakovredni odmerek

železa

Največja količina

sterilne 0,9 % m/v

raztopine natrijevega

klorida

Najkrajši čas

dajanja zdravila

4 ml

200 mg

50 ml

> 4

10 ml

> 200

500 mg

100 ml

6 minut

> 10

20 ml

> 500

1.000 mg

250 ml

15 minut

Ukrepi spremljanja

Ponovno oceno mora opraviti zdravnik na podlagi znakov posameznega bolnika. Raven hemoglobina

(Hb) se lahko ponovno oceni šele po 4 tednih od zadnje uporabe zdravila Iroprem, da se zagotovi

dovolj časa za eritropoezo in izrabo železa. Če ima bolnik še vedno potrebe po zapolnitvi z železom, je

treba te potrebe znova izračunati s pomočjo zgornje tabele 1.

Inkompatibilnosti

Absorpcija peroralnega železa se zmanjša ob sočasnemu jemanju s parenteralnimi železovimi

pripravki. Zato peroralnega zdravljenja z železom, če je potrebno, ni dovoljeno začeti prej kot vsaj 5

dni po zadnji injekciji zdravila Iroprem.

Preveliko odmerjanje

Uporaba zdravila Iroprem v količinah, večjih od količine, potrebne za popravek primanjkljaja železa v

času uporabe, lahko povzroči kopičenje železa v telesnih zalogah, kar lahko sčasoma povzroči

hemosiderozo. Spremljanje parametrov železa, na primer serumskega feritina in saturacije transferina,

lahko pomaga prepoznati kopičenje železa. Če je prišlo do nakopičenja železa, zdravite v skladu s

standardno medicinsko prakso, npr. razmislite o uporabi kelatorja železa.

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

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

&quot;The environment has a real impact on the risk of cancer, although it remains difficult to assess&quot;: 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