PROPAFENON ALKALOID-INT

Glavne informacije

  • Zaščiteno ime:
  • PROPAFENON ALKALOID-INT 150 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • propafenon 135,54 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 40 tabletami (4 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • PROPAFENON ALKALOID-INT 150 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • propafenon

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-1323/11
  • Datum dovoljenje:
  • 22-07-2011
  • EAN koda:
  • 3837000057355
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

Navodilo za uporabo

PROPAFENON ALKALOID-INT 150 mg filmsko obložene tablete

propafenoni hydrochloridum

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 s svojim zdravnikom ali s 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 s svojim zdravnikom ali s farmacevtom.

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

Navodilo vsebuje:

1. Kaj je zdravilo PROPAFENON ALKALOID-INT in za kaj ga uporabljamo

2. Kaj morate vedeti, preden boste vzeli zdravilo PROPAFENON ALKALOID-INT

3. Kako jemati zdravilo PROPAFENON ALKALOID-INT

4. Možni neželeni učinki

5. Shranjevanje zdravila

PROPAFENON ALKALOID-INT

6. Vsebina pakiranja in dodatne informacije

1. Kaj je zdravilo PROPAFENON ALKALOID-INT in za kaj ga uporabljamo

Zdravilo

PROPAFENON

ALKALOID-INT

spada

skupino

zdravil,

imenujemo

antiaritmiki (zdravila za zdravljenje in preprečevanje motenj srčnega ritma). Upočasni bitje

srca in pomaga uravnavati srčni utrip.

Zdravilo PROPAFENON ALKALOID-INT se uporablja za zdravljenje in preprečevanje

motenj srčnega ritma.

2. Kaj morate vedeti, preden boste vzeli zdravilo PROPAFENON ALKALOID-INT

Ne jemljite zdravila PROPAFENON ALKALOID-INT:

- če ste alergični na propafenon ali katerokoli sestavino tega zdravila (navedeno v poglavju

- če imate motnjo srčnega ritma, ki se imenuje Brugada sindrom,

- če ste doživeli srčno kap od katere še niso minli trije meseci,

- če imate nenadzorovano srčno popuščanje (iztisni delež levega prekata je manj kot 35 %),

- če ste v srčnem šoku (šok pri srčni odpovedi), razen če ga je povzročila motnja srčnega

ritma,

- če je vaš utrip upočasnjen in povzroča bolezenske simptome,

- če imate motnje srčnega ritma (nepravilno delovanje sinusnega vozla, motnje atrijskega

prevajanja, AV blok II., ali večje stopnje, kračni blok ali distalni blok) brez srčnega

spodbujevalnika,

- če imate zelo nizek krvni tlak,

- če imate očitno neravnovesje elektrolitov (kot so na primer motnje presnove kalija),

- če imate hudo bolezen pljuč z zožitvijo bronhijev,

- če imate mišično bolezen, ki se imenuje miastenija gravis (redka bolezen, za katero sta

značilni šibkost mišic in hitra utrudljivost),

- če se zdravite z ritonavirjem (protivirusno zdravilo).

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila PROPAFENON ALKALOID-INT se posvetujte s svojim

zdravnikom, zaradi naslednjih pomembnih razlogov:

Vaš zdravnik bo moral opraviti klinični pregled in elektrokardiografsko preiskavo (EKG),

da lahko oceni, ali je to zdravilo primerno za vas.

Propafenon

lahko,

podobno

druga

antiaritmična

zdravila,

poslabša

motnjo

srčnega ritma, obenem pa lahko povzroči nastanek nove, zato vas bo vaš zdravnik

med zdravljenjem s propafenom klinično in elektrokardiografsko pozorno spremljal.

Če ste bolnik z astmo, vas bo zdravnik previdno spremljal.

Propafenon lahko vpliva na delovanje vašega umetnega srčnega spodbujevalnika,

zato bo vaš zdravnik med zdravljenjem s propafenonom ustrezno spremljal njegovo

delovanje in ga po potrebi reprogramiral.

Druga zdravila in zdravilo PROPAFENON ALKALOID-INT

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

morda začeli jemati katero koli drugo zdravilo.

Še posebej morate zdravniku povedati, če jemljete:

- propranolol, metoprolol ali druga zdravila iz skupine antagonistov adrenergičnih receptorjev

beta (zdravila, ki se uporabljajo za zdravljenje povišanega krvnega tlaka, motenj srčnega

ritma in/ali srčnega popuščanja),

- amiodaron ali kinidin (zdravili za zdravljenje motenj srčnega ritma),

- digoksin (zdravilo za zdravljenje srčnega popuščanja),

- varfarin ali fenprokumon (zdravili za preprečevanje tvorbe krvnih strdkov),

- teofilin (zdravilo, ki se uporablja za zdravljenje astme),

- ciklosporin (zdravilo, ki se uporablja po presaditvi organov ali za zdravljenje vnetja sklepov

ali luskavice),

triciklične

antidepresive

(npr.

dezipramin),

selektivne

zaviralce

ponovnega

privzema

serotonina kot sta na primer fluoksetin in paroksetin, venlafaksin (zdravila za zdravljenje

depresije),

- cimetidin (zdravilo za zdravljenje razjed v požiralniku, želodcu ali dvanajstniku),

- rifampicin ali eritromicin (antibiotika),

- ketokonazol (zdravilo proti glivičnim okužbam),

- fenobarbital (zdravilo za epilepsijo),

sočasno

uporabo

lokalnih

anestetikov

primer

vsaditvijo

srčnega

spodbujevalnika, kirurškim posegom ali stomatološko operacijo) se zveča nevarnost pojava

nevroloških neželenih učinkov, zato morate zdravniku/stomatologu pred posegom/operacijo

povedati, da jemljete zdravilo PROPAFENON ALKALOID-INT.

Zdravilo PROPAFENON ALKALOID-INT skupaj s hrano in pijačo

Izogibajte se pitju grenivkinega soka, če jemljete to zdravilo. Obvezno morate zdravniku

povedati, če pijete grenivkin sok.

Nosečnost in dojenje

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

svojim zdravnikom ali s farmacevtom, preden vzamete to zdravilo.

Nosečnost

Varnost

uporabe

propafenona

nosečnostjo

dokazana.

Zdravilo

PROPAFENON

ALKALOID-INT se sme med nosečnostjo uporabljati samo, kadar je njegova možna korist

večja od morebitnega tveganja za plod. Vaš zdravnik bo zdravljenje določil po temeljitem

zdravniškem pregledu.

Dojenje

Varnost

uporabe

propafenona

obdobjem

dojenja

dokazana.

Omejeni

podatki

nakazujejo,

lahko

propafenon

ljudeh

izločal

materino

mleko.

Zdravilo

PROPAFENON ALKALOID-INT se mora med obdobjem dojenja uporabljati previdno.

Vpliv na sposobnost upravljanja vozil in strojev

Dokler ne veste, kako te tablete delujejo na vas, ni priporočljivo, da vozite, upravljate s stroji

ali opravljate katerokoli delo, ki zahteva pozornost. Zamegljen vid, omotica, utrujenost in

padec arterijskega tlaka ob vstajanju ali pri nepremičnem stanju (ortostatska hipotenzija), ki se

lahko pojavijo med zdravljenjem z zdravilom PROPAFENON ALKALOID-INT, lahko

namreč vplivajo na hitrost vašega reagiranja in zmanjšajo vašo sposobnost za upravljanje

vozil ali strojev.

Zdravilo PROPAFENON ALKALOID-INT vsebuje laktozo

Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega

zdravila posvetujte s svojim zdravnikom.

3. Kako jemati zdravilo PROPAFENON ALKALOID-INT

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

se posvetujte s svojim zdravnikom ali s farmacevtom.

Zdravnik vam bo povedal kako pogosto in kakšen odmerek zdravila boste jemali in kako

dolgo bo trajalo zdravljenje. Odmerkov zdravila ne smete spreminjati ali zdravljenja

prekinjati, ne da bi se prej posvetovali z zdravnikom.

Tablete morate pogoltniti, ne da bi jih žvečili. Najbolje je, da jih vzamete po jedi in z nekaj

vode.

Odmerek zdravila PROPAFENON ALKALOID-INT je treba določiti za vsakega bolnika

posebej, in sicer na podlagi njegovega terapevtskega odziva in prenašanja. Vaš zdravnik bo

odmerek določil po temeljitem zdravniškem pregledu.

Odrasli

Priporočen začetni odmerek je 150 mg (1 tableta) na vsakih osem ur (450 mg/dan = 3

tablete/dan ).

Odmerek se lahko čez tri do štiri dni zveča na 225 mg (1,5 tablete) na vsakih osem ur

(675 mg/dan = 4,5 tablet /dan), ali če je to potrebno na 300 mg (2 tableti) na vsakih

osem ur (900 mg/dan = 6 tablet/dan).

Učinkovitost in varnost jemanja dnevnih odmerkov, večjih od 900 mg (6 tablet), nista

dokazani.

Starejši

Starejšim in bolnikom s hudo okvaro srčne mišice je treba začetni odmerek propafenona

(podobno kot drugih antiaritmičnih zdravil) zvečevati počasi.

Uporaba pri otrocih in mladostnikih (do 18 let)

Uporabi propafenona pri mlajših od 18 let se je treba izogibati, saj varnost in učinkovitost

uporabe pri njih nista popolnoma dokazani.

Bolniki z jetrno in/ali ledvično okvaro

Pri bolnikih z okvarjenim delovanjem jeter in/ali ledvic se lahko po standardnih terapevtskih

odmerkih

pojavi

kopičenje

zdravila.

Tudi

bolnikih

koncentracijo

zdravila

PROPAFENON ALKALOID-INT mogoče določati vendar ob ob spremljanju EKG-ja in

plazme.

Če menite, da je učinek zdravila premočan ali prešibak, se posvetujte z zdravnikom ali s

farmacevtom.

Če ste vzeli večji odmerek zdravila PROPAFENON ALKALOID-INT, kot bi smeli

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

farmacevtom.

Simptomi prevelikega odmerjanja so različne motnje srčnega ritma in znižanje krvnega tlaka.

Pogosto se lahko pojavijo glavobol, omotica, zamegljen vid, nenormalen občutek v koži kot

žarenje, zbadanje, ščegetanje (parestezije), hitro, ritmično tresenje mišic, udov in drugih delov

telesa (tremor), občutek siljenja na bruhanje, zaprtje in suha usta.

V hudih primerih prevelikega odmerjanja se lahko pojavijo krči (konvulzije), nenormalen

občutek v koži kot žarenje, zbadanje, ščegetanje (parestezije), motnje zavesti (bolezenska

zaspanost, koma) in zastoj dihanja.

Če ste pozabili vzeti zdravilo PROPAFENON ALKALOID-INT

Ne pozabite vzeti zdravila.

Odmerek, ki ste ga pozabili vzeti, vzemite čim se spomnite, razen če je že skoraj čas za

naslednji odmerek. Če je tako, izpustite pozabljeni odmerek. Ob času naslednjega odmerka

nadaljujte s predpisanim zdravljenjem.

Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.

Če ste prenehali jemati zdravilo PROPAFENON ALKALOID-INT

Če ste prenehali jemati zdravilo ne da bi se posvetovali s svojim zdravnikom, se vaše

zdravstveno stanje lahko poslabša. Pomembno je, da tablete jemljete, dokler vam zdravnik ne

naroči, da nehajte. Ne prenehajte jemati zdravila samo zato, ker se počutite bolje.

Nenadno prenehanje zdravljenja s propafenonom ni priporočljivo. Odmerek zdravila je treba

zmanjševati postopno.

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

farmacevtom.

4. Možni neželeni učinki

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

bolnikih.

Zelo pogosti neželeni učinki (pojavijo se lahko pri več ko 1 od 10 bolnikov):

-

omotica,

-

motnje srčnega ritma,

neprijetni občutki ob hitrem ali močnem utripanju srca (palpitacije).

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

tesnoba (anksioznost),

motnje spanja,

glavobol,

sprememba okusa,

zamegljen vid,

počasno bitje srca (sinusna bradikardija, bradikardija) in hitro utripanje srca

(tahikardija),

motnja srčnega ritma (atrijska undulacija),

oteženo dihanje (dispneja),

bolečine v trebuhu,

bruhanje,

občutek siljenja na bruhanje,

driska,

zaprtje,

suha usta,

nenormalno delovanje jeter,

bolečine v prsnem košu,

pomanjkanje ali izguba moči in energije (astenija),

utrujenost,

zvišana telesna temperatura.

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

zmanjšano število krvnih ploščic v krvi (trombocitopenija),

zmanjšan apetit,

nočne more,

nenadna kratkotrajna nezavest (sinkopa),

motena usklajenost mišičnih gibov (ataksija),

nenormalen občutek v koži kot žarenje, zbadanje, ščegetanje (parestezije),

vrtoglavica,

motnja srčnega ritma (ventrikularna tahikardija, aritmija),

nizek krvni tlak (hipotenzija),

napihnjenost trebuha,

napenjanje,

koprivnica,

srbenje,

izpuščaj,

rdečina,

nezmožnost moškega za spolno občevanje ali oploditev (erektilna disfunkcija).

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

spremenjene

vrednosti

nekaterih

krvnih

testov

(agranulocitoza,

levkopenija,

granulocitopenija),

preobčutljivost,

stanje zmedenosti,

krči (konvulzije),

motnje nehotenega gibanja (ekstrapiramidni simptomi),

nemir,

motnja srčnega ritma (ventrikularna fibrilacija),

srčno popuščanje,

zmanjšan srčni utrip,

padec krvnega tlaka ob vstajanju ali pri nepremičnem stanju (ortostatska hipotenzija),

bljuvanje,

motnje prebave,

okvara jetrnih celic,

zastoj žolča (holestaza),

vnetje jeter (hepatitis),

zlatenica,

sindrom podoben eritematoznemu lupusu (redka avtoimunska bolezen),

zmanjšanje števila semenčic.

Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s

farmacevtom. Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem

navodilu.

5. Shranjevanje zdravila PROPAFENON ALKALOID-INT

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

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

ovojnini

poleg

oznake

EXP.

Datum

izteka

roka

uporabnosti

nanaša

zadnji

navedenega meseca.

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

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

pomagajo varovati okolje.

6. Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo PROPAFENON ALKALOID-INT

Zdravilna učinkovina je propafenon.

Ena filmsko obložena tableta vsebuje 150 mg propafenonijevega klorida, kar ustreza

135,54 mg propafenona.

Druge sestavine zdravila so mikrokristalna celuloza (E460), povidon, magnezijev

stearat

(E572),

smukec

(E553b),

laktoza

monohidrat,

natrijev

karboksimetilškrob

(vrsta A) in natrijev lavrilsulfat v jedru tablete ter titanov dioksid (E171), hipromeloza

(E464) in makrogol 400 v filmski oblogi tablete.

Izgled zdravila PROPAFENON ALKALOID-INT in vsebina pakiranja

Filmsko obložena tableta je bela, okrogla, na obeh straneh izbočena z zarezo na eni strani.

Tableta se lahko deli na enaki polovici.

Škatla s 40 filmsko obloženimi tabletami, v 4 pretisnih omotih po 10 tablet.

Način izdaje zdravila PROPAFENON ALKALOID-INT

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

ALKALOID-INT d.o.o., Šlandrova ulica 4, Ljubljana-Črnuče, R Slovenija

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

predstavništvo imetnika dovoljenja za promet z zdravilom:

ALKALOID-INT d.o.o.,

Šlandrova ulica 4,

Ljubljana-Črnuče,

R Slovenija

Tel.: 01 - 300 42 90

Faks: 01 - 300 42 91

E-pošta: info@alkaloid.si

Navodilo je bilo nazadnje revidirano dne 26.02.2013.

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Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

20-9-2018

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Health Canada's sampling and evaluation program has determined that the rubber animals do not meet the Canadian safety requirements for toys. The squeakers inside the rubber animals can be easily removed; these small parts pose a choking hazard to young children.

Health Canada

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

10-9-2018

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

In some circumstances the tempered glass pane may break or shatter unexpectedly into small pieces and may pose laceration injuries to consumers.

Health Canada

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

21-8-2018

Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products

Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products

On 1 July 2018, a new executive order entered into force which gives companies the possibility of cultivating medicinal cannabis and producing cannabis bulk and cannabis primary products from Danish-grown cannabis.

Danish Medicines Agency

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

19-7-2018

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd is voluntarily recalling K9 Natural Frozen Chicken Feast 11lb bags, batch number #150517, that were imported into the Canadian market in July 2017 because they have the potential to be contaminated with Listeria monocytogenes. No other K9 Natural products are affected in Canada.

Health Canada

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

18-7-2018

Intragastric balloon systems

Intragastric balloon systems

Safety information for Intragastric Balloon Systems

Therapeutic Goods Administration - Australia

11-7-2018

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

Danish Medicines Agency

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

6-6-2018

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.

FDA - U.S. Food and Drug Administration

4-6-2018

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.

FDA - U.S. Food and Drug Administration

29-5-2018

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion Voluntary Recall Due to Possible Health Risk

Pious Lion located in Asheville, NC is voluntarily recalling two of their Kratom products: Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz and Pious Lion Pure Premium Potent White Maeng DA, Bright Uplifting Energy, 4 oz due to the presence of Salmonella . Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhe...

FDA - U.S. Food and Drug Administration

25-5-2018

Nosocomial infections can also be caused by the Bacillus cereus bacterium

Nosocomial infections can also be caused by the Bacillus cereus bacterium

While Bacillus cereus is well known as a source of food infections, researchers from INRA and ANSES, working with doctors at nine French hospitals[1] including those in the Paris Public Hospital System (AP-HP), have demonstrated for the first time that this bacterium is also responsible for inter- and intra-hospital nosocomial contamination.

France - Agence Nationale du Médicament Vétérinaire

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

23-5-2018

Golden International Corporation  Issues Public Safety Warning For Stolen Tilapia Because  of Possible Health Risk

Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk

Golden International Corporation of Renton, WA is issuing a public safety notice for 405 cartons of stolen frozen tilapia, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection wi...

FDA - U.S. Food and Drug Administration

21-5-2018

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into ...

FDA - U.S. Food and Drug Administration

8-5-2018

New Tariff for fees collected by the Icelandic
Medicines Agency

New Tariff for fees collected by the Icelandic Medicines Agency

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

IMA - Icelandic Medicines Agency

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2018)5731 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/095/18

Europe -DG Health and Food Safety

20-8-2018

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care.  https://www.facebook.com/CDC/  #OnePairTakeCarepic.twitter.com/Akf1Dz93Xx

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care. https://www.facebook.com/CDC/  #OnePairTakeCarepic.twitter.com/Akf1Dz93Xx

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care. https://www.facebook.com/CDC/  #OnePairTakeCare pic.twitter.com/Akf1Dz93Xx

FDA - U.S. Food and Drug Administration

29-6-2018

New warnings on labels of medicines containing neuromuscular blocking agents

New warnings on labels of medicines containing neuromuscular blocking agents

New requirements for neuromuscular blocking agent containing medicines come into effect on 2 July

Therapeutic Goods Administration - Australia

4-6-2018

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports-  https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

29-5-2018

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Active substance: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles) - Orphan designation - Commission Decision (2018)3393 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/017/18

Europe -DG Health and Food Safety