LEGOFER

Glavne informacije

  • Zaščiteno ime:
  • LEGOFER 40 mg/15 ml peroralna raztopina
  • Farmacevtska oblika:
  • peroralna raztopina
  • Sestava:
  • železo(III) 40 mg / 15 ml
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s stekleničko s 150 ml raztopine in plastičnim pokrovčkom z odmernikom
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • LEGOFER 40 mg/15 ml peroralna raztopina
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • železov(III) proteinsukcinilat

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-428/12
  • Datum dovoljenje:
  • 28-02-2012
  • EAN koda:
  • 3837000013498
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

JAZMP-IB/012-02.06.2016

Navodilo za uporabo

LEGOFER

40 mg/15 ml peroralna raztopina

železo (III)

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.

Kaj vsebuje navodilo

Kaj je zdravilo LEGOFER in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo LEGOFER

Kako jemati zdravilo LEGOFER

Možni neželeni učinki

Shranjevanje zdravila LEGOFER

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo LEGOFER in za kaj ga uporabljamo

Zdravilo LEGOFER vsebuje zdravilno učinkovino

železov (III) proteinsukcinilat

. Ta spada v

skupino zdravil za zdravljenje slabokrvnosti (anemije).

To zdravilo se uporablja za

zdravljenje in preprečevanje

slabokrvnosti

, ki je posledica

pomanjkanja železa:

pri zvečani porabi železa

(pri nedonošenčkih, novorojenčkih z majhno telesno maso ob

rojstvu, v obdobju nagle rasti, med puberteto, med nosečnostjo in dojenjem);

-

pri motnjah prehajanja snovi iz prebavil v kri

(npr. pri vnetju prebavil,

malabsorpcijskem sindromu, po kirurški odstranitvi dela ali vsega želodca);

-

pri zvečani izgubi zaradi krvavitev

(npr. pri

prepogosti menstruaciji, menstruaciji z

veliko izgubo krvi, pri nerednih krvavitvah iz maternice (tudi zaradi novotvorb imenovanih

miomi), pri krvavitvi iz prebavil (zaradi razjede sluznice požiralnika, želodca, dvanajstnika

ali debelega črevesa, zaradi prisotnosti številnih polipov v črevesu ali zaradi hemoroidov)

in pri pojavu krvi v urinu).

JAZMP-IB/012-02.06.2016

2.

Kaj morate vedeti, preden boste vzeli zdravilo LEGOFER

Ne jemljite zdravila LEGOFER:

-

če ste alergični na železov (III) proteinsukcinilat ali katero koli sestavino tega zdravila

(navedeno v poglavju 6),

-

če imate motnjo za katero je značilno kopičenje železa v telesu (hemosiderozo,

hemokromatozo),

če imate slabokrvnost, ki ni posledica pomanjkanja železa (aplastično anemijo, hemolitično

anemijo, sideroakrestično anemijo, anemijo zaradi zastrupitve s svincem),

če imate kronično vnetje trebušne slinavke,

če imate hudo jetrno odpoved (jetrno cirozo).

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila LEGOFER se posvetujte z zdravnikom ali farmacevtom.

Bodite posebno pozorni pri jemanju zdravila LEGOFER:

Zdravilo vsebuje mlečne beljakovine. Če ne prenašate mlečnih beljakovin, se posvetujte z

zdravnikom.

Zdravljenje s tem zdravilom naj ne traja dlje kot 6 mesecev, razen če vam je zdravnik

predpisal drugače (npr. pri močnih in dolgo trajajočih menstruacijskih krvavitvah ali med

nosečnostjo).

Med zdravljenjem bo zdravnik z ustreznimi preiskavami krvi redno spremljal

koncentracijo železa v krvi ter krvno sliko.

To zdravilo lahko moti laboratorijske preiskave za odkrivanje skritih krvavitev iz prebavil.

Pred preiskavo opozorite zdravstveno osebje, da jemljete zdravilo LEGOFER.

Otroci in mladostniki

Zdravilo LEGOFER se lahko uporablja pri otrocih in mladostnikih.

Druga zdravila in zdravilo LEGOFER

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

jemati katero koli drugo zdravilo, tudi če sta ga dobili brez recepta.

Če potrebujete sočasno zdravljenje z zdravilom LEGOFER in drugim zdravilom (ki je našteto

spodaj), naj bo med odmerkom tega drugega zdravila in odmerkom zdravila LEGOFER

dvourni

časovni razmik

. Ta zdravila so:

bisfosfonati (zdravila za zdravljenje bolezni kosti),

metildopa (zdravilo za zniževanje povišanega krvnega tlaka),

penicilamin (zdravilo za zdravljenje revmatoidnega artritisa),

tiroksin (zdravilo za zdravljenje bolezni ščitnice),

zdravila za zdravljenje okužb (iz skupine tetraciklinov, kinolonov),

zdravila za zdravljenje Parkinsonove bolezni (levodopa, karbidopa, entakapon).

Prav tako se posvetujte z zdravnikom, če poleg zdravila LEGOFER že uporabljate katero od

naslednjih zdravil:

antacide (zdravila za zmanjšanje kislosti želodčne vsebine),

kloramfenikol (antibiotik),

dimerkaprol (zdravilo za zdravljenje zastrupitve s težkimi kovinami),

pripravke, ki vsebujejo cink,

JAZMP-IB/012-02.06.2016

pripravke, ki vsebujejo več kot 200 mg askorbinske kisline (vitamina C).

Zdravilo LEGOFER

skupaj s hrano in pijačo

To zdravilo jemljite na tešče. Nekatere snovi, ki so prisotne v zelenjavi, mleku, kavi in čaju, vplivajo

na prehajanje železa iz prebavil v kri, zato vzemite zdravilo LEGOFER vsaj

dve uri po zaužitju

omenjene hrane oziroma pijač.

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.

Zdravilo LEGOFER je namenjeno zdravljenju in preprečevanju pojava slabokrvnosti zaradi

pomanjkanja železa v obdobjih nosečnosti in dojenja.

Vpliv na sposobnost upravljanja vozil in strojev

Zdravilo LEGOFER nima vpliva na sposobnost vožnje in upravljanja strojev.

Zdravilo LEGOFER vsebuje konzervans natrijev metilparahidroksibenzoat (E219) in

konzervans natrijev propilparahidroksibenzoat (E217)

. Lahko povzročita alergijske reakcije

(lahko zapoznele).

Zdravilo LEGOFER vsebuje sorbitol (E420).

Če vam je zdravnik povedal, da ne prenašate

nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.

Zdravilo LEGOFER vsebuje natrij.

To zdravilo vsebuje 1,9 mmol (43,83 mg) natrija na 15 ml

peroralne raztopine. To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.

3.

Kako jemati zdravilo LEGOFER

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

se posvetujte z zdravnikom ali farmacevtom.

Uporaba pri odraslih

Priporočeni dnevni odmerek je od

15 do 30 ml

peroralne raztopine. Dnevni odmerek razdelite na

2 dela.

Uporaba pri otrocih in mladostnikih

Priporočeni dnevni odmerek je

1,5 ml

peroralne raztopine

na kg telesne mase

. Dnevni odmerek

razdelite na 2 dela.

Način uporabe

Predpisani odmerek zdravila

nalijte v odmernik

in ga

popijte na tešče

. Po uporabi stekleničko

takoj dobro zaprite.

Če ste vzeli večji odmerek zdravila LEGOFER, kot bi smeli

Če ste vzeli večji odmerek zdravila kot bi smeli, se takoj posvetujte z zdravnikom ali

farmacevtom.

Zaužitje večje količine tega zdravila lahko povzroči bolečine v zgornjem delu trebuha, slabost,

JAZMP-IB/012-02.06.2016

zaspanost, bledico, pomodrelost kože in sluznic zaradi pomanjkanja kisika (cianozo), šok in

nezavest. Če ste vi ali drugi bolnik pri zavesti, poskušajte izzvati bruhanje in takoj poiščite

zdravniško pomoč.

Če ste pozabili vzeti zdravilo LEGOFER

Če ste pozabili vzeti posamezni odmerek zdravila, vzemite naslednjega kot običajno. Ne vzemite

dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste prenehali jemati zdravilo LEGOFER

Ne prekinjajte zdravljenja z zdravilom LEGOFER in ne spreminjajte odmerkov, razen če vam je

tako svetoval zdravnik, saj se vaša bolezen lahko ponovi.

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.

Neželeni učinki, ki se lahko pojavijo med zdravljenjem z zdravilom LEGOFER, so našteti spodaj.

Njihove pogostnosti pojavljanja iz razpoložljivih podatkov ni možno oceniti.

Neželeni učinki na prebavila:

driska,

zaprtje,

slabost,

bruhanje,

bolečine v zgornjem delu trebuha,

temno obarvano blato.

Poročanje o neželenih učinkih

Če opazite katerega koli izmed neželenih učinkov, 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

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.

JAZMP-IB/012-02.06.2016

5.

Shranjevanje zdravila LEGOFER

Zdravilo shranjujte nedosegljivo otrokom!

Pred odprtjem steklenice:

Za shranjevanje zdravila niso potrebna posebna navodila.

Po odprtju steklenice:

Peroralna raztopina zdravila LEGOFER je po odprtju steklenice pri temperaturi do 25

C in

zaščitena pred svetlobo obstojna 30 dni.

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

steklenici poleg oznake »EXP«. Rok uporabnosti zdravila 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 LEGOFER

Zdravilna učinkovina je železov (III) proteinsukcinilat.

15 ml peroralne raztopine zdravila LEGOFER vsebuje 800 mg železovega (III)

proteinsukcinilata, kar ustreza 40 mg trivalentnega železa (Fe

1 ml peroralne raztopine zdravila LEGOFER vsebuje 53,3 mg železovega (III)

proteinsukcinilata, kar ustreza 2,7 mg trivalentnega železa (Fe

Druge sestavine zdravila so 70 % tekoči (nekristalizirajoči) sorbitol (E420), propilenglikol

(E1520), konzervans E219 (natrijev metilparahidroksibenzoat ), konzervans E217 (natrijev

propilparahidroksibenzoat), natrijev saharinat, natrijev hidroksid (E524), prečiščena voda

in aroma višnje.

Izgled zdravila LEGOFER in vsebina pakiranja

Zdravilo LEGOFER je rdeče-rjava bistra raztopina z vonjem črne višnje.

Zdravilo je na voljo v škatli, ki vsebuje temnorjavo steklenico s 150 ml peroralne raztopine in

plastični pokrovček z odmernikom. V škatli je priloženo navodilo za uporabo zdravila.

Način in režim predpisovanja in izdaje zdravila LEGOFER

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

ALKALOID-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče

JAZMP-IB/012-02.06.2016

R Slovenija

Tel.: 01 - 300 42 90

Faks: 01 - 300 42 91

E-pošta: info@alkaloid.si

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

dovoljenja za promet z zdravilom.

Navodilo je bilo nazadnje revidirano dne 02.06.2016

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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

25-9-2018

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

FDA Announces FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA

The U.S. Food and Drug Administration announced in the Federal Register today the fiscal year 2019 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III).

FDA - U.S. Food and Drug Administration

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

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

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

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

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

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

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

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

27-7-2018

Scientific guideline:  Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

Scientific guideline: Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version, draft: consultation open

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

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

27-6-2018

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Active substance: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII) - Transfer of orphan designation - Commission Decision (2018)4099 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/17/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Active substance: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)3382 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/18

Europe -DG Health and Food Safety

8-3-2018

Human coagulation factor VIII

Human coagulation factor VIII

Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Corrigendum - Commission Decision (2017)7630 of Thu, 08 Mar 2018

Europe -DG Health and Food Safety