Ferrum Lek

Glavne informacije

  • Zaščiteno ime:
  • Ferrum Lek 50 mg/5 ml sirup
  • Farmacevtska oblika:
  • Sirup
  • Sestava:
  • železo 50 mg / 5 ml
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s stekleničko s 100 ml sirupa
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Ferrum Lek 50 mg/5 ml sirup
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • kompleksi železovega(III) oksida in polimaltoze

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:
  • 5363-I-769/09
  • Datum dovoljenje:
  • 01-07-2009
  • EAN koda:
  • 3837000004649
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP-IB/004,IB/008-13.02.2014

Navodilo za uporabo

Ferrum Lek 100 mg žvečljive tablete

Ferrum Lek 50 mg/5 ml sirup

ŽELEZO (III)

Kaj vsebuje navodilo

1. Kaj je zdravilo Ferrum Lek in za kaj ga uporabljamo

2. Kaj morate vedeti, preden boste vzeli zdravilo Ferrum Lek

3. Kako jemati zdravilo Ferrum Lek

4. Možni neželeni učinki

5. Shranjevanje zdravila Ferrum Lek

6. Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Ferrum Lek in za kaj ga uporabljamo

Železo se v telesu nahaja v rdečih krvničkah, mišicah in encimih. Pomanjkanje železa lahko

povzroči kronično utrujenost, nezbranost, razdražljivost, živčnost, glavobol, neješčnost,

občutljivost za stres in okužbe, bledost, razpoke v kotičkih ust (ragade), suho kožo ter lomljive

lase in nohte.

V žvečljivih tabletah in sirupu zdravila Ferrum Lek je železo v kompleksu železovega(III)

hidroksida v ogljikohidratnem polimeru (polimaltozi). To preprečuje, da bi železo povzročilo

kakršnokoli škodo v prebavilih. Varuje tudi pred medsebojnim delovanjem železa in hrane.

Struktura kompleksa železovega(lll) hidroksida s polimaltozo je podobna kot pri naravni

shranjevalni beljakovini za železo (feritin). Zaradi te podobnosti železo prehaja v kri po naravnih

mehanizmih.

Zdravilo Ferrum Lek se uporablja za:

zdravljenje prikritega pomanjkanja železa,

zdravljenje slabokrvnosti (anemije), ki je posledica pomanjkanja železa (izraženo

pomanjkanje železa),

preprečevanje pojava pomanjkanja železa med nosečnostjo.

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 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-IB/004,IB/008-13.02.2014

2.

Kaj morate vedeti, preden boste vzeli zdravilo Ferrum Lek

Ne jemljite zdravila Ferrum Lek

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

(navedeno v poglavju 6),

če imate preveliko količino železa v telesu (npr. pri hemokromatozi, hemosiderozi),

če imate motnje pri izrabljanju železa (npr. pri slabokrvnosti zaradi zastrupitve s svincem,

sideroakrestični anemiji, talasemiji),

če imate slabokrvnost, ki ni posledica pomanjkanja železa (npr. hemolitično anemijo).

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Ferrum Lek se posvetujte z zdravnikom ali farmacevtom.

Če ste slabokrvni zaradi okužbe ali rakave bolezni se pred začetkom jemanja tega zdravila

posvetujte z zdravnikom.

Če bo zdravilo Ferrum Lek jemal otrok, mlajši od 12 let, je zanj primeren manjši odmerek tega

zdravila; namesto tablet je zanj primerna uporaba sirupa (glejte tudi 3. poglavje »Kako jemati

zdravilo Ferrum Lek«).

Med zdravljenjem s tem zdravilom in drugimi železovimi pripravki se vam lahko blato temno

obarva, vendar to nima kliničnega pomena.

Druga zdravila in zdravilo Ferrum Lek

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

jemati, katero koli drugo zdravilo.

Doslej niso opazili medsebojnega delovanja z drugimi zdravili. Železo v zdravilu Ferrum Lek je

vezano v kompleks, kar zelo zmanjša verjetnost za medsebojno delovanje s sestavinami hrane

(oksalati (v zelenjavi)), pijačo (npr. tanini v čaju) in zdravili (zdravili za zdravljenje okužb iz

skupine tetraciklinov, antacidi). Prav tako ne vpliva na preskus za odkritje prikritih krvavitev (ki je

selektiven za hemoglobin), zato zdravljenja z železom ni treba ustaviti. Zdravilo prav tako ne

obarva zobne sklenine.

Sočasni uporabi tega zdravila z drugimi oblikami zdravila, ki vsebujejo železo (injekcije in

tablete), se je potrebno izogibati, zato obvestite zdravnika, če jemljete zdravilo Ferrum Lek in

druga zdravila ali pripravke, ki vsebujejo železo.

Nosečnost in dojenje

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

zdravnikom ali farmacevtom, preden vzamete to zdravilo.

V raziskavah o vplivu na sposobnosti razmnoževanja pri živalih niso ugotovili nevarnosti za plod.

Na podlagi teh raziskav dokazov o nevarnosti uporabe v prvem tromesečju ni, škodljiv vpliv na

plod pa je malo verjeten. Tudi v kontroliranih raziskavah, v katere so bile vključene ženske po

prvem trimesečju nosečnosti, ni bilo opaziti neželenih učinkov na matere in/ali plod.

Železo se izloča v materino mleko in veže v beljakovino, ki je prisotna v mleku. Iz železovega

kompleksa se v mleko izloči le majhna neznana količina železa. Možnost pojava neželenih

učinkov pri dojenih otrocih je majhna.

JAZMP-IB/004,IB/008-13.02.2014

Jemanje zdravila Ferrum Lek je med nosečnostjo in dojenjem dovoljeno samo po posvetu z

zdravnikom.

Vpliv na sposobnost upravljanja vozil in strojev

Zdravilo Ferrum Lek nima vpliva na sposobnost vožnje in upravljanja s stroji.

Zdravilo Ferrum Lek vsebuje aspartam

Zdravilo Ferrum Lek žvečljive tablete vsebujejo aspartam (E951), ki je izvor fenilalanina, in sicer

1,5 mg na tableto. Zdravilo lahko škoduje ljudem s fenilketonurijo.

Zdravilo Ferrum Lek vsebuje saharozo in sorbitol

5 ml sirupa zdravila Ferrum Lek vsebuje 1 g saharoze in 1,4 g sorbitola. Če vam je zdravnik

povedal, da ne prenašate nekaterih sladkorjev (imate intoleranco), se pred uporabo tega

zdravila posvetujte z zdravnikom.

Zdravilo Ferrum Lek vsebuje etanol

Sirup zdravila Ferrum Lek vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg

na odmerek (do 16 mg na 5 ml).

Zdravilo Ferrum Lek vsebuje metilparahidroksibenzoat in propilparahidroksibenzoat

Sirup zdravila Ferrum Lek vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat

(E216), ki lahko povzročita alergijske reakcije (te so lahko zapoznele).

3.

Kako jemati zdravilo Ferrum Lek

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika. Če ste negotovi, se

posvetujte z zdravnikom ali farmacevtom. Odmerjanje in trajanje zdravljenja sta odvisna od tega,

kolikšno je pomanjkanje železa. Odmerki so predstavljeni tudi v preglednici.

Način uporabe

Zdravilo Ferrum Lek vzemite med jedjo ali takoj po jedi. Dnevni odmerek lahko razdelite

na več manjših odmerkov ali pa vzamete ves dnevni odmerek naenkrat.

Zdravilo Ferrum Lek žvečljive tablete prežvečite ali pogoltnite cele.

Zdravilo Ferrum Lek sirup lahko zmešate s sadnimi in zelenjavnimi sokovi oziroma ga

lahko dodate v hrano za dojenčke. Rahlo obarvanje hrane ali pijače ne vpliva na okus ali

na učinkovitost zdravila.

Za natančno odmerjanje sirupa uporabljajte priloženo merilno žličko. Priložena merilna

žlička ima oznaki za odmerjanje 2,5 ml in 5 ml. Volumen polne merilne žličke je 6 ml.

Zdravljenje izraženega pomanjkanja železa

Zdravljenje traja od 3 do 5 mesecev. Zdravnik vam lahko zdravljenje predpiše tudi za daljši čas,

kar je odvisno od vaših izvidov laboratorijskih preiskav krvi.

Odmerjanje žvečljivih tablet ali sirupa zdravila Ferrum Lek pri:

dojenčkih do 1. leta starosti: začetni odmerek je 2,5 ml sirupa. Zdravnik bo odmerek

postopoma povečal na 5 ml sirupa na dan.

otrocih, stari 1 do 12 let: 5 do 10 ml sirupa na dan.

otrocih, starih več kot 12 let, odraslih in doječih materah: običajen dnevni odmerek je

1 do 3 žvečljive tablete ali 10 do 30 ml sirupa.

JAZMP-IB/004,IB/008-13.02.2014

nosečnicah: 2 do 3 žvečljive tablete ali 20 do 30 ml sirupa na dan. Nato je treba najmanj

do konca nosečnosti jemati 1 žvečljivo tableto ali 10 ml sirupa na dan.

Zdravljenje prikritega pomanjkanja železa

Zdravljenje traja približno 1 do 2 meseca.

Odmerjanje žvečljivih tablet ali sirupa zdravila Ferrum Lek pri:

dojenčkih do 1. leta starosti ni možno, ker je odmerek zdravila premajhen za dajanje.

otrocih, starih 1 do 12 let: 2,5 do 5 ml sirupa na dan.

otrocih, starih več kot 12 let, odraslih in doječih materah: 1 žvečljiva tableta ali 5 do

10 ml sirupa na dan.

nosečnicah: 1 žvečljiva tableta ali 5 do 10 ml sirupa na dan.

Preprečevanje pomanjkanja železa pri nosečnicah

1 žvečljiva tableta ali 5 do 10 ml sirupa zdravila Ferrum Lek na dan.

Preglednica prikazuje dnevno odmerjanje zdravila Ferrum Lek za preprečevanje in zdravljenje

pomanjkanja železa.

farmacevtska

oblika

izraženo

pomanjkanje

železa

prikrito

pomanjkanje

železa

preprečevanje

pomanjkanja

železa

dojenčki

(do 1. leta)

sirup

2,5–5 ml

otroci

(1–12 let)

sirup

5–10 ml

2,5–5 ml

otroci

(> 12 let),

odrasli in

doječe matere

žvečljive

tablete

sirup

1–3 tablete

10–30 ml

1 tableta

5–10 ml

nosečnice

žvečljive

tablete

sirup

2–3 tablete

20–30 ml

1 tableta

10 ml

1 tableta

5–10 ml

(--)Odmerek zdravila je tako majhen, da zdravljenje s tabletami ali sirupom ni možno.

Če ste vzeli večji odmerek zdravila Ferrum Lek, kot bi smeli

Če ste po nesreči vzeli večji odmerek zdravila, kot bi smeli, se posvetujte z zdravnikom.

Do sedaj niso poročali o primerih zastrupitve ali prekomernega odmerjanja z zdravilom Ferrum

Lek.

Če ste pozabili vzeti zdravilo Ferrum Lek,

vzemite naslednji odmerek takoj, ko se boste spomnili, nato pa ga jemljite kot običajno. Ne

vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

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

JAZMP-IB/004,IB/008-13.02.2014

4.

Možni neželeni učinki

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

Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):

trebušne bolečine, zaprtje, driska, siljenje na bruhanje (navzea), želodčne bolečine,

prebavne težave ali nelagodje zlasti v zgornjem delu trebuha (dispepsija), bruhanje

koprivnica, izpuščaj, srbenje

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. 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 zagotovitvi več informacij o varnosti tega zdravila.

5.

Shranjevanje zdravila Ferrum Lek

Zdravilo shranjujte nedosegljivo otrokom!

Žvečljive tablete: Shranjujte pri temperaturi do 25

Sirup: Shranjujte pri temperaturi do 25

C. Rok uporabnosti po prvem odprtju je 2 meseca.

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 Ferrum Lek

Zdravilna učinkovina je železo v obliki kompleksa železovega(III) hidroksida s polimaltozo

(dekstriferon).

1 žvečljiva tableta vsebuje 100 mg železa (Fe

), kar ustreza 312,5 mg do 357,14 mg

kompleksa železovega(III) hidroksida s polimaltozo (dekstriferona).

1 ml sirupa vsebuje 10 mg železa (Fe

), kar ustreza 31,25 mg do 35,71 mg kompleksa

železovega(III) hidroksida s polimaltozo (dekstriferona).

5 ml sirupa vsebuje 50 mg železa (Fe

), kar ustreza 156,25 mg do 178,55 mg kompleksa

železovega(III) hidroksida s polimaltozo (dekstriferona).

Druge sestavine zdravila (pomožne snovi) so:

v zdravilu Ferrum Lek 100 mg žvečljive tablete: dekstrat, makrogol 6000, aspartam (E951),

smukec (E553b) in esenca čokolade.

v zdravilu Ferrum Lek 50 mg/5 ml sirup: sorbitol (E420), saharoza, 96 odstotni etanol,

esenca kremna, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216),

natrijev hidroksid (E524) in prečiščena voda.

JAZMP-IB/004,IB/008-13.02.2014

Izgled zdravila Ferrum Lek in vsebina pakiranja

Zdravilo Ferrum Lek 100 mg žvečljive tablete so na voljo v škatli s 3 dvojnimi trakovi ali 3

pretisnimi omoti po 10 žvečljivih tablet s 100 mg železa v obliki kompleksa železovega(III)

hidroksida s polimaltozo (dekstriferona). Tablete so rjavo-bele barve, melirane, okrogle, ravne

ter s posnetimi robovi.

Zdravilo Ferrum Lek 50 mg/5 ml sirup je na voljo v škatli s stekleničko s 100 ml sirupa in

priloženo merilno žličko. Priložena merilna žlička ima oznaki za odmerjanje 2,5 ml in 5 ml.

Sirup je rjava in bistra raztopina.

Način izdaje zdravila Ferrum Lek

Rp - Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

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

Izdelovalec

Lek farmacevtska družba d. d., Verovškova 57, 1526 Ljubljana, Slovenija po licenci Vifor

(International) Inc., St.Gallen, Švica

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

za promet z zdravilom.

Navodilo je bilo nazadnje revidirano

13.02.2014

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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