KLERCIDE-CR BIOCIDE X UNIT DOSE CONCENTRATE

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  • KLERCIDE-CR BIOCIDE X UNIT DOSE CONCENTRATE (ES)
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  • KLERCIDE-CR BIOCIDE X UNIT DOSE CONCENTRATE (ES)
    Hrvatska
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  • hrvatski

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Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 115976E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

Klercide-CR Biocide X Unit Dose Concentrate

SIGURNOSNO- TEHNIČKI LIST

Ime proizvoda

Klercide-CR Biocide X Unit Dose Concentrate

Odgovara Regulativi (EC) br. 1907/2006 (REACH), Annex II (453/2010) - Europa

:

1.1 Identifikator proizvoda

1.3 Podaci o dobavljaču koji isporučuje sigurnosno tehnički list

1.2 Odgovarajuće identificirane namjene tvari ili smjese i namjene koje se ne preporučuju

Identificirane uporabe

ODJELJAK 1: Identifikacija tvari/smjese i podaci o tvrtki/poduzeću

Kod proizvoda

:

Ne preporučive uporabe

1.4 Telefon zа hitne slučajeve

Služba za izvanredna stanja

Sredstvo za dezinfekciju površina. Manualni proces

Nisu poznati.

Ecolab d.o.o.

Zavrtnica 17

10 000 Zagreb

tel: +385 1 6321 600

fax: +385 1 6321 633

email:iva.nola@ecolab.com

:

Proizvođač/ Distributer/

Uvoznik

:

Broj telefona

Tel.: 112

115976E

Uporaba proizvoda

:

Sredstvo za dezinfekciju površina

Samo za profesionalnu uporabu

Medicinske informacije

:

Broj telefona

+385 (0)1 2348 342

Izdanje

: 1

Razvrstavanje

Xn; R22

C; R34

N; R50/53

:

:

Opasnosti za ljudsko

zdravlje

Štetno ako se proguta. Izaziva opekotine. U dodiru s kožom može izazvati

preosjetljivost.

:

Opasnosti za okoliš

Vrlo otrovno za organizme koji žive u vodi, može dugotrajno štetno djelovati u vodi.

Vidjeti odjeljak 11 za detaljnije informacije o utjecajima na zdravlje i mogućim simptomima.

ODJELJAK 2: Identifikacija opasnosti

2.1 Razvrstavanje tvari ili smjese

Definicija proizvoda

:

Smjesa

Vidjeti Odjeljak 16 za cijeli tekst R, H i EUH oznaka.

Razvrstavanje prema Uredbi 1999/45/EZ [DPD]

Proizvod je klasificiran kao opasno sredstvo prema odredbi 1999/45/EC i njenim dopunama.

2.2 Elemenati označavanja prema direktivi 1999/45/EZ ili uredbi (EZ-a) br. 1272/2008 (CLP)

Simbol ili simboli za

opasnost

:

Datum izdanja/Datum revizije

:

1/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 2: Identifikacija opasnosti

:

Druge opasnosti koje ne

rezultiraju u klasifikaciji

Nisu poznati.

Oznake obavijesti

S2- Čuvati izvan dohvata djece.

S13- Čuvati odvojeno od hrane, pića i stočne hrane.

S23- Ne udisati plin, pare ili aerosol.

S26- Ako dođe u dodir s očima odmah isprati s puno vode i zatražiti savjet liječnika.

S36/37- Nositi odgovarajuću zaštitnu odjeću i rukavice.

S45- U slučaju nesreće ili zdravstvenih tegoba hitno zatražiti savjet liječnika (ako je

moguće pokazati naljepnicu).

S60- Ostaci tvari i ambalaža moraju se odložiti kao opasan otpad.

S61- Izbjegavati ispuštanje u okoliš. Pridržavati se posebnih uputa - sigurnosni list.

R 22 Štetno ako se proguta

R 34 Izaziva opekotine

R 43 U dodiru s kožom može izazvati preosjetljivost

R50/53 Vrlo otrovno za organizme koji žive u vodi, može dugotrajno štetno djelovati

u vodi

Oznake upozorenja

Sadrži

:

:

:

Nagrizajuće, Opasno za okoliš

Benzalkonij klorid

poliheksametilen biguanid hidroklorid

Indikacija opasnosti

:

2.3 Druge opasnosti

Nadzor nad izloženošću, ako je dostupno navedeno je u odjeljku 8.

Ne postoje dodatni sastojci koji su, u okviru sadašnjeg znanja dobavljača i u primjenljivim koncentracijama, klasificirani

opasnim po zdravlje ili okoliš i stoga zahtijevaju podnošenje izvještaja u ovom odjeljku.

ODJELJAK 3: Sastav/informacije o sastojcima

[1] Supstance koje su klasificirane kao opasne za zdravlje ili okolinu

[2] Supstance koje imaju zadanu granicu izlaganja na radnom mjestu

[3] Tvar ispunjava kriterije za PBT prema Propisu (EZ) Br 1207/2006, Aneks XIII

[4] Tvar ispunjava kriterije za vPvB prema Propisu (EZ) Br 1207/2006, Aneks XIII

[5] Tvar ekvivalentne pozornosti

Br. po REACH-u EC/

CAS/Indeks

67/548/EEC

Naziv proizvoda/

sastojka

%

Tip

Pravilo (EC) Br.

1272/2008 [CLP]

Razvrstavanje

Vidjeti odjeljak 16 za

cijeli tekst R-oznaka

gore deklariranih

Vidjeti Odjeljak 16 za

cijeli tekst H-oznaka

gore deklariranih

Benzalkonij klorid

EC: 270-325-2

CAS: 68424-85-1

25 -

<35

Xn; R22

C; R34

N; R50

Acute Tox. 4, H302

Skin Corr. 1B, H314

Aquatic Acute 1, H400

poliheksametilen

biguanid hidroklorid

CAS: 91403-50-8

10 -

<20

Xi; R36/38

N; R51/53

Skin Irrit. 2, H315

Eye Irrit. 2, H319

Skin Sens. 1, H317

Aquatic Chronic 2, H411

Mješavine

3.2

Datum izdanja/Datum revizije

:

2/13

21 siječnja 2014

HZTA

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Nema.

Klercide-CR Biocide X Unit Dose Concentrate

Smjesta tražiti liječničku pomoć. Isprati usta vodom. Ukloniti umjetno zubalo ako

postoji. Premjestiti unesrećenog na svježi zrak, umiriti ga i postaviti u položaj koji

olakšava disanje. Ne izazivati povraćanje osim ako to nije naloženo od strane

medicinskog osoblja. Ukoliko dođe do povraćanja, glavu treba držati spuštenom

tako da izbljuvak ne uđe u pluća. Liječnik mora smjesta tretirati kemijske opekline.

Osobi bez svijesti nikad ništa ne davati na usta. Ukoliko je osoba bez svijesti,

postaviti je u bočni položaj i smjesta osigurati liječničku pomoć. Održavati slobodan

protok zraka. Popustiti usku odjeću poput okovratnika, kravate, pojasa ili remena.

Kontakt s kožom

Smjesta tražiti liječničku pomoć. Odmah isprati oči s velikom količinom vode, te

povremeno podići gornje i donje kapke. Provjeriti postojanje leća te iste ukloniti.

Nastaviti ispirati najmanje 10 minuta. Liječnik mora smjesta tretirati kemijske

opekline.

Isprati kontaminiranu kožu s puno vode. Skinuti kontaminiranu odjeću i cipele.

Oprati kontaminiranu odjeću prije ponovne upotrebe. Nastaviti ispirati najmanje 10

minuta. Liječnik mora smjesta tretirati kemijske opekline. U slučaju ikakvih žalbi ili

simptoma, izbjegavati daljnje izlaganje. Temeljito očistiti cipele prije ponovne

upotrebe. Smjesta tražiti liječničku pomoć.

4.1 Opis mjera prve pomoći

Smjesta tražiti liječničku pomoć. Premjestiti unesrećenog na svježi zrak, umiriti ga i

postaviti u položaj koji olakšava disanje. Ukoliko se sumnja da su zagušljiva

isparenja i dalje prisutna, spasilac treba nositi odgovarajuću filtarsku polumasku s

filtrima za čestice ili samostalni dišni aparat. Ukoliko nema disanja, ukoliko je

disanje neregularno ili ukoliko dođe do zastoja u disanju, medicinsko osoblje treba

obezbijediti umjetno disanje ili kisik. Oživljavanje usta na usta može biti opasno po

pružaoca pomoći. Ukoliko je osoba bez svijesti, postaviti je u bočni položaj i

smjesta osigurati liječničku pomoć. Održavati slobodan protok zraka. Popustiti

usku odjeću poput okovratnika, kravate, pojasa ili remena.

Gutanje

Udisanje

Kontakt očima

:

:

:

:

Zaštita pružaoca prve

pomoći

:

ODJELJAK 4: Mjere prve pomoći

4.2 Najvažniji simptomi i efekti, i akutni i odloženi

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Mogu se ispuštati plinovi ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Štetno ako se proguta. Može izazvati opekline usta, grla i želuca.

:

Gutanje

Kontakt s kožom

:

Nagriza kožu. Izaziva opekotine. U dodiru s kožom može izazvati preosjetljivost.

nagriza oči Izaziva opekotine.

:

Kontakt očima

Znaci/simptomi pretjeranog izlaganja

Kontakt s kožom

Udisanje

Štetni simptomi mogu uključivati slijedeće:

nadražaj dišnog sustava

kašljanje

Štetni simptomi mogu uključivati slijedeće:

bol ili nagrizanje

crvenilo

može se dogoditi stvaranje mjehura

:

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti aktivnost za koju

osoba nije prošla odgovarajuću obuku. Ukoliko se sumnja da su zagušljiva

isparenja i dalje prisutna, spasilac treba nositi odgovarajuću filtarsku polumasku s

filtrima za čestice ili samostalni dišni aparat. Oživljavanje usta na usta može biti

opasno po pružaoca pomoći. Temeljito vodom oprati kontaminiranu odjeću prije

skidanja, ili nositi rukavice.

Datum izdanja/Datum revizije

:

3/13

21 siječnja 2014

HZTA

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Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 4: Mjere prve pomoći

Obavijesti liječniku

Tretirati po simptomima. Kontaktirati liječnika specijalistu za otrove odmah ukoliko

je osoba progutala ili udisala velike količine.

:

Dodatna upozorenja

Gutanje

Štetni simptomi mogu uključivati slijedeće:

bolovi u želucu

:

4.3 Indikacija potrebe za liječničkom pomoći bez odgode i specijalnim liječenjem

Nema specifičnog liječenja.

:

U slučaju požara odmah izolirati mjesto događaja uklanjanjem svih osoba koje se

nalaze u blizini. Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti

aktivnost za koju osoba nije prošla odgovarajuću obuku. Ovaj materijal je vrlo

toksičan za vodene organizme. Voda koja se koristi za gašenje vatre,

kontaminirana ovim materijalom mora biti lokalizirana i spriječeno njeno istjecanje u

bilo koji vodotok, kanalizaciju ili odvod.

Opasni samozapaljivi

proizvodi

Opasnosti od tvari ili

smjese

Nema specifičnih podataka.

U slučaju požara ili ako grijano, dogoditi će se porast tlaka i posuda može prsnuti.

Vatrogasci moraju nositi prikladnu zaštitnu opremu.

Posebna oprema za

zaštitu vatrogasaca

U slučaju požara, koristiti vodeni sprej (maglu), pjenu, suhe kemijske tvari ili CO

5.1 Sredstva za gašenje požara

:

:

:

Nisu poznati.

Odgovarajuća sredstva za

gašenje

:

Neodgovarajuća sredstva

za gašenje

:

ODJELJAK 5: Mjere za suzbijanje požara

5.2 Specijalne opasnosti koje proističu od tvari ili smjese

5.3 Savjet za vatrogasce

Specijalna mjere

predostrožnosti za

vatrogasce

:

6.2 Mjere zaštite okoliša

Izbjegavati rasipanje prosutog materijala i otjecanje ili kontakt sa tlom, vodotocima,

odvodima i kanalizacijom. Obavijestiti odgovarajuće vlasti ukoliko je proizvod

prouzročio zagađenje okoliša (kanalizacije, vodotokova, tla ili zraka). Materijal koji

zagađuje vodu. Može biti škodljivo za okoliš ukoliko je oslobođeno u velikim

količinama.

6.3 Metode i materijali za zadržavanje i čišćenje

ODJELJAK 6: Mjere kod slučajnog ispuštanja

6.1 Osobne mjere predostrožnosti, zaštitna oprema i postupci u slučaju hitnih slučajeva

Za ne-interventno osoblje

:

Za interventno osoblje

:

Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti aktivnost za koju

osoba nije prošla odgovarajuću obuku. Evakuirati susjedne prostore. Spriječiti

ulazak nepotrebnog i nezaštićenog osoblja. Ne dodirivati niti prolaziti kroz proliveni

materijal. Ne udisati pare ili maglu. Osigurati odgovarajuću ventilaciju. Nosite

prikladnu zaštitnu filtarsku polumasku s fitrima za čestice kad je ventilacija

neadekvatna. Staviti prikladnu osobnu zaštitnu opremu.

Ako je specijalizirana odjeća potrebna za rješavanje izlijevanja, treba obratiti pažnju

na bilo kakve informacije u Odjeljku 8 o prikladnim i neprikladnim materijalima.

Vidjeti također Odjeljak 8 za dodatne informacije o higijenskim mjerama.

:

Datum izdanja/Datum revizije

:

4/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 6: Mjere kod slučajnog ispuštanja

Spriječiti prilaz kanalizaciji, vodotocima, podrumima ili zatvorenim prostorima.

Zadržati negorivim i pokupiti izliveno, adsorbirajućim materijalom na pr. pijeskom,

zemljom, vermikulitom, diatomejskom zemljom i smjestiti u kontejner za odlaganje u

skladu s zahtjevima zaštite okoliša i zakonima o odlaganju otpada (vidjeti odjeljak

13).

Veliko izlijevanje

:

Razrijediti s puno vode. Adsorbirati s inertnim materijalom i smjestiti u odgovarajući

kontejner za odlaganje otpada.

Malo izlijevanje

:

6.4 Upućivanje na druge

odjeljke

Vidjeti Odjeljak 1 za konakt za hitne informacije.

Vidjeti Odjeljak 8 za informacije o prikladnoj osobnoj zaštitnoj opremi.

Vidjeti Odjeljak 13 za dodatne informacije o obradi otpada.

:

Skladištiti na temperaturi između: 0 do 25°C (32 do 77°F). Skladištiti u skladu sa

lokalnim uredbama. Skladištiti u originalnom spremniku zaštićeno od izravnog

sunčevog svjetla, u suhom, hladnom i dobro ventiliranom prostoru, daleko od

nekompatiblinih materijala (vidjeti odjeljak 10), te hrane i pića. Držati spremnik

čvrsto zatvoren i zapečaćen dok nije spreman za uporabu. Posude koje su

otvorene moraju biti pažljivo nanovo zabrtvljene i držane uspravno radi sprječavanja

odlijevanja. Ne skladištiti u neobilježenim kontejnerima. Koristiti odgovarajuću

ambalažu kako bi se spriječilo zagađivanje okoliša.

ODJELJAK 7: Rukovanje i skladištenje

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Popis identificiranih uporaba u Odjeljku 1 bi se trebao

proučiti za bilo koje dostupno korištenje specifičnih informacija u Scenariju(ima) izloženosti.

7.1 Mjere predostrožnosti za sigurno rukovanje

Sigurnosne mjere

:

Savjet o općoj

profesionalnoj higijeni

:

7.2 Uvjeti za sigurno

skladištenje, uključujući

bilo koje nekompatibilnosti

7.3 Specifični krajnji korisnik(ci)

Staviti odgovarajuću osobnu zaštitnu opremu (vidjeti odjeljak 8). Osobe koje imaju

probleme sa osjetljivom kožom ne bi trebale raditi niti u jednom procesu gdje se

upotrebljava ovaj proizvod. Ne smije dospjeti u oči ili na kožu. Ne udisati pare ili

maglu. Ne gutati. Izbjegavati ispuštanje u okoliš. Pridržavati se posebnih uputa -

sigurnosni list. Ukoliko tijekom normalne uporabe materijal prestavlja opasnost po

disanje, koristiti samo uz odgovarajuću ventilaciju ili nositi odgovarajući respirator.

Čuvati u u originalnom kontejneru ili odobrenom alternativnom napravljenom od

kompatibilnog materijala, držanog čvrsto zatvorenim kad nije u upotrebi. Prazni

spremnici sadrže ostatke proizvoda i mogu biti opasni. Ne koristiti ponovno

kontejner.

Jedenje, pijenje i pušenje trebaju biti zabranjeni u prostorima gdje se rukuje s ovim

materijalom, skladišti i procesira. Radnici trebaju oprati ruke i lice prije jedenja,

pijenja i pušenja. Ukloniti kontaminiranu odjeću i zaštitnu opremu prije ulaženja u

prostore gdje se jede. Vidjeti također Odjeljak 8 za dodatne informacije o

higijenskim mjerama.

:

Preporuke

:

Specifične otopine za

industrijski sektor

:

Nije primjenjivo dok scenarij izloženosti za tvari ne bude dostupan.

Nije primjenjivo dok scenarij izloženosti za tvari ne bude dostupan.

Datum izdanja/Datum revizije

:

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:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

Zaštita ruku

(HRN EN 374)

Filtarska polumaska nije potrebna pod normalnim i namijenjenim uvjetima uporabe

proizvoda.

1 - 4 sati : butil-guma , nitril-guma .

Zaštitne naočale. Zaštita za lice u obliku vizira.

Zaštita оčiju/lica

(HRN EN 166)

Zaštita dišnih puteva

(HRN EN 143, 14387)

:

:

:

Zaštita kože

Osobna zaštitna oprema za tijelo treba biti odabrana na osnovu posla koji se

obavlja i rizika uključenih i treba biti odobrena od strane specijaliste prije obrade

ovog proizvoda.

:

Kontrole izlaganja zaštite

okoliša

:

Emisije iz ventilacije ili opreme radnog procesa trebaju biti prekontrolirane radi

osiguranja da udovoljavaju zahtjevima zakonskih propisa o ekološkoj zaštiti. U

nekim slučajevima, čistači plina, filteri ili inženjerske preinake procesne opreme biti

će neophodne za redukciju emisija na prihvatljive nivoe.

Odgovarajuće inženjerske

kontrole

:

Ukoliko se pri rukovanju stvaraju plinovi, para ili magla, upotrijebiti procesne

zatvorene prostore, lokalnu ventilaciju ispušnih plinova ili druge mehaničke

upravljačke uređaje radi očuvanja izlaganja radnika kontaminantima u zraku ispod

preporučenih ili zakonskih limita.

Temeljito oprati ruke, podlaktice i lice nakon rukovanja kemijskim proizvodima, prije

jela, pušenja ili korištenja toaleta te po svršetku radnog vremena. Odgovarajuće

tehnike trebaju biti korištene pri uklanjanju potencijalno kontaminirane odjeće.

Zagađena radna odjeća ne smije se iznositi izvan radnog prostora. Oprati

kontaminiranu odjeću prije ponovne upotrebe. Osigurati da su mjesta za ispiranje

očiju i tuševi blizu radnih mjesta.

8.2 Tehničke mjere za smanjenje izloženosti

Higijenske mjere

:

DNEL nije primjenjivo za smjese.

PNEC

PNEC nije primjenjivo za smjese.

ODJELJAK 8: Nadzor nad izloženošću/osobna zaštita

8.1 Kontrolni parametri

DNEL

Individualne mjere zaštite

Zaštita tijela

(HRN EN 14605)

:

Druga zaštita kože

(HRN EN 13832)

Termičke opasnosti

:

Odgovarajuća obuća i sve dodatne mjere zaštite kože trebaju biti odabrani na

temelju zadatka koji se obavlja kao i rizika koji su uključeni i trebaju biti odobreni od

strane stručnjaka prije rukovanja s ovim proizvodom.

Nema.

Naziv proizvoda/sastojka

Granične vrijednosti izloženosti

Limit profesionalnog izlaganja

Nije poznata vrijednost granice izlaganja.

ODJELJAK 9: Fizikalna i kemijska svojstva

Agregatno stanje

Tekućina.

Slab miris.

Miris

Bezbojno.

Boja

Prag mirisa:

:

:

:

:

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Izgled

Ne može se primijeniti i /ili odrediti iz mješavine.

Datum izdanja/Datum revizije

:

6/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 9: Fizikalna i kemijska svojstva

Talište

Vrelište

Tlak pare

Relativna gustoča

Gustoća pare

Topljivost(i)

0.99 do 1.03

Lako topivo u slijedećim materijalima: hladnoj vodi.

pH

Brzina isparavanja

Temperatura samozapaljena

Plamište

> 100°C

4 do 6 [Konc. (% t/t): 100%]

Viskozitet

Kinematički (sobna temperatura): 0 cm

Oktanol/voda koeficijent

raspodjele

Eksplozivnost

:

:

:

:

:

:

:

:

:

:

:

:

:

Ne postoji.

Oksidativnost

:

9.2 Ostale informacije

Vrijeme izgaranja

Brzina izgaranja

:

:

Temperatura dekompozicije

:

Nema dodatnih informacija.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Nema.

Gornje/donje granice

zapaljivosti ili eksplozivnosti

:

Ne može se primijeniti i /ili odrediti iz mješavine.

Zapaljivost (krutina, plin)

:

Ne može se primijeniti i /ili odrediti iz mješavine.

10.6 Opasni proizvodi

raspadanja

10.4 Uvjeti koje treba

izbjegavati

Nema specifičnih podataka.

Pod normalnim uvjetima skladištenja i uporabe, opasni proizvodi raspadanja ne bi

smjeli biti proizvedeni.

Proizvod je stabilan.

10.2 Kemijska stabilnost

:

:

:

10.3 Mogućnost opasnih

reakcija

:

Pod normalnim uvjetima skladištenja i uporabe, opasne reakcije se neće dogoditi.

ODJELJAK 10: Stabilnost i reaktivnost

10.1 Reaktivnost

:

Na raspolaganju nema specifičnih test podataka vezanih za reaktivnost za ovaj

proizvod ili njegove sastojke.

10.5 Nekompatibilni

materijali

:

Nema specifičnih podataka.

Datum izdanja/Datum revizije

:

7/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Mogu se ispuštati plinovi ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Štetno ako se proguta. Može izazvati opekline usta, grla i želuca.

:

Gutanje

Kontakt s kožom

:

Nagriza kožu. Izaziva opekotine. U dodiru s kožom može izazvati preosjetljivost.

nagriza oči Izaziva opekotine.

:

Kontakt očima

akutno trovanje

Benzalkonij klorid

LD50 Kožni

Kunić

3340 mg/kg

LD50 Oralno

Štakor

344 mg/kg

Naziv proizvoda/sastojka

Rezultat

Vrste

Doza

Izlaganje

Karcinogenost

Mutagenost

Teratogenost

Reproduktivna toksičnost

Simptomi u svezi s fizičkim, kemijskim i toksikološkim karakteristikama

Kontakt s kožom

Gutanje

Udisanje

Nema specifičnih podataka.

Štetni simptomi mogu uključivati slijedeće:

bolovi u želucu

Štetni simptomi mogu uključivati slijedeće:

bol ili nagrizanje

crvenilo

može se dogoditi stvaranje mjehura

:

:

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

Iritacija/korozija

Benzalkonij klorid

Koža - jako nadražujuće

Kunić

25 milligrams

Naziv proizvoda/sastojka

Rezultat

Rezultat

Izlaganje

Promatranje

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Preosjetljivost

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Vrste

ODJELJAK 11: Toksikološke informacije

11.1 Informacije o toksikološkim učincima

Put

ATE vrijednost

Efekti sa i bez odgode te također kronični efekti od kratkotrajnog i dugotrajnog izlaganja

Kratkotrajno izlaganje

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Informacije o vjerojatnim

putevima izlaganja

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Potencijalni neposredni

učinci

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Datum izdanja/Datum revizije

:

8/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 11: Toksikološke informacije

Potencijalne kronične zdravstvene posljedice

Jednom senzitiziran, može se dogoditi jaka alergijska reakcija pri naknadnim

izlaganjima vrlo niskim nivoima.

Opća

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Karcinogenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Mutagenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Teratogenost

:

Razvojni efekti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Efekti fertilnosti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Dugotrajno izlaganje

Potencijalni odgođeni

učinci

:

Potencijalni neposredni

učinci

:

Potencijalni odgođeni

učinci

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Ostale informacije

:

Značajne posljedice ili kritične opasnosti nisu poznate.

ODJELJAK 12: Ekološke informacije

12.3 Bioakumulativni potencijal

12.6 Drugi štetni efekti

Značajne posljedice ili kritične opasnosti nisu poznate.

12.1 Otrovnost

Benzalkonij klorid

Akutni LC50 0.515 mg/l

Riba

96 sati

Naziv proizvoda/sastojka

Vrste

Rezultat

Izlaganje

12.2 Postojanost i razgradivost

Zaključak/Sažetak

:

Ekološka evaluacija proizvoda bazira se na podacima o sirovinama i sličnim

substancama. Sve organske substance sadržane u proizvodu dostižu >60% BOD/

COD ili CO2 otpuštanje, ili >70% DOC redukciju u testovima lakše razgradljivosti -

granične vrijednosti za "readily" razgradljivost (prema OECD metodi 301)

PBT

:

Nema.

vPvB

:

Nema.

12.4 Pokretljivost kroz tlo

12.5 Rezultati OBT i vPvB procjene

:

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Tlo/voda koeficijent

raspodjele (K

OC

)

:

Nema podataka za proizvod.

Pokretljivost

:

Nema podataka za proizvod.

Zaključak/Sažetak

:

Nema podataka za proizvod.

Datum izdanja/Datum revizije

:

9/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

Katalog Europskog otpada (EWC)

Opasni otpad

:

Stvaranje otpada treba izbjegavati ili umanjiti gdje god je to moguće. Prazni

kontejneri ili cijevi mogu zadržati nešto ostatka proizvoda. Ostaci tvari i spremnici

moraju biti odloženi na siguran način. Značajne količine otpadnog ostatka

proizvoda ne bi trebale biti odložene putem kanalizacije, nego procesirane u

odgovarajućem pogonu za obradu otpadne vode. Ukloniti suvišak i ne-reciklirajuće

proizvode preko ovlaštene osobe za odlaganje otpada. Odlaganje ovog proizvoda,

otopine i bilo kojeg nus proizvoda mora uvijek biti u skladu sa zahtjevima zaštite

okoliša i zakonima o odlaganju otpada i bilo kojim regionalnim zahtjevima lokalne

uprave. Izbjegavati rasipanje prosutog materijala i otjecanje ili kontakt sa tlom,

vodotocima, odvodima i kanalizacijom.

:

Metode odlaganja

ODJELJAK 13: Zbrinjavanje

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Popis identificiranih uporaba u Odjeljku 1 bi se trebao

proučiti za bilo koje dostupno korištenje specifičnih informacija u Scenariju(ima) izloženosti.

13.1 Metode prerade otpada

Proizvod

Pakiranje

Kod otpada

Oznaka otpada

Metode odlaganja

:

Specijalne mjere

predostrožnosti

:

20 01 29*

deterdženti koji sadrže opasne tvari

Stvaranje otpada treba izbjegavati ili umanjiti gdje god je to moguće. Ambalažni

otpad treba biti recikliran.

Ostaci tvari i spremnici moraju biti odloženi na siguran način. Treba paziti pri

rukovanju praznim spremnicima koji nisu bili očišćeni ili isprani. Prazni kontejneri ili

cijevi mogu zadržati nešto ostatka proizvoda. Izbjegavati rasipanje prosutog

materijala i otjecanje ili kontakt sa tlom, vodotocima, odvodima i kanalizacijom.

NAGRIZAJUĆA

TEKUĆINA

(Benzalkonij klorid,

poliheksametilen

biguanid hidroklorid)

CORROSIVE LIQUID,

N.O.S. (Benzalkonium

chloride,

Polyhexamethylene

biguanide

hydrochloride). Marine

pollutant

Corrosive liquid, n.o.s.

(Benzalkonium

chloride,

Polyhexamethylene

biguanide

hydrochloride)

UN1760

NAGRIZAJUĆA

TEKUĆINA

(Benzalkonij klorid,

poliheksametilen

biguanid hidroklorid)

UN1760

UN1760

UN1760

ODJELJAK 14: Informacije o prijevozu

ADR/RID

IMDG

IATA

14.1 UN broj

14.2 UN ispravni

otpremni naziv

14.3 Klasa(e)

opasnosti pri

transportu

14.4 Ambalažna

skupina

ADN/ADNR

14.5 Opasnosti za

okoliš

Yes.

Datum izdanja/Datum revizije

:

10/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 14: Informacije o prijevozu

14.6 Specijalna

mjere

predostrožnosti

za korisnika

14.7 Transport u

nezapakiranom stanju

prema Aneks II MARPOL

73/78 i IBC Kodu

:

Nema.

Ne postoji.

Ne postoji.

None.

None.

Nacionalna regulativa

Ostala EU pravila

Nema.

Aneks XVII – Restrikcija

na proizvodnju,

stavljanje na tržište i

uporabu određenih

opasnih tvari, smjesa i

artikala

:

Hrvatska

ODJELJAK 15: Informacije o propisima

15.1 Pravila/zakonski propisi o sigurnosti, zdravlju i zaštiti okoliša, specifični za tvar ili smjesu

EU Pravilo (EC) Br 1907/2006 (REACH)

Aneks XIV – Lista tvari podvrgnutih odobrenju

15.2 Procjena sigurnosti

kemikalije

Ovaj proizvod sadrži supstance za koje su Procjene sigurnosti kemikalija još uvijek

neophodne.

Supstance vrlo visoke zabrinutosti

:

Ni jedna komponenta nije izlistana.

≥ 30% kationski tenzidi

Deklaracija o sastojcima prema regulativi o deterdžentima 648/2004/EC:

Zakon o kemikalijama, Pravilnik o razvrstavanju, označavanju, obilježavanju i pakiranju opasnih kemikalija-rađen

prema DSD i DPD direktivama, Pravilnik o razvrstavanju, označavanju, obilježavanju i pakiranju opasnih kemikalija-

rađen prema CLP-u Zakon o biocidnim pripravcima , Pravilniku o dokumentaciji za ocjenu aktivne tvari u biocidnim

pripravcima, dokumentaciji za ocjenu biocidnih pripravaka, postupcima ocjenjivanja biocidnih pripravaka i njihove

uporabe te o vrstama biocidnih pripravaka s njihovim opisima i jedinstvenim načelima za ocjenjivanje biocidnih

pripravaka, Pravilniku o popisu aktivnih tvari u biocidnim pripravcima, Pravilniku o popisu postojećih aktivnih tvari

dopuštenih u biocidnim pripravcima, Pravilniku o popisu postojećih aktivnih tvari koje nisu dopuštene u biocidnim

pripravcima, Pravilniku o ispunjavanja Sigurnosno-tehničkog lista , Pravilnik o graničnim vrijednostima izloženosti

opasnim tvarima pri radu i o biološkim graničnim vrijednostima, Zakon o zaštiti na radu, Zakon o prijevozu opasnih

tvari, Pravilnik o deterdžentima.

Datum izdanja/Datum revizije

:

11/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

21 siječnja 2014

Datum tiskanja

:

Naznačuje informacije koje su se promijenile od prethodne izdane verzije.

ODJELJAK 16: Ostale informacije

Kratice i akronimi

:

ADN = European Provisions concerning the International Carriage of Dangerous

Goods by Inland Waterway

ADR = Europski sporazum u vezi s internacionalnim prijevozom opasne robe cestom

ATE- Procijenjene vrijednosti akutne toksičnosti.

BKF = Biokoncentracijski faktor

CLP- Uredba o razvrstavanju, označavanju i pakiranju kemijskih tvari i mješavina

(regulativa (EU) br. 1272/2008

DNEL - Izvedena razina izloženosti bez učinka

DPD = Direktiva o opasnim pripravcima [1999/45/EZ]

EC = Europska Komisija

EUH izjava - CLP Ddopunske oznake upozorenja

IATA = Internacionalno udruženje zračnog transporta

IBC = Kontejner srednjeg obujma

IMDG = Internacionalne pomorski opasne tvari

LogPow = logaritam koeficijenta razdjeljenja između oktanola i vode

MARPOL 73/78 = Internacionalna konvencija za prevenciju zagađivanja od brodova,

1973 modificirano protokolom iz 1978. ("Marpol" = zagađenje mora)

OEL = Profesionalna granica izloženosti

PBT = Postojan, bioakumulativni i toksični

PNEC - Predviđena koncentracija bez učinka

REACH = Registracija, Evaluacija, Autorizacija i Restrikcija Kemijskih Regulativa

[Uredba (EZ) Br. 1907/2006]

RID = Uredba u vezi internacionalnog prijevoza opasnih tvari željezničkim putem

REACH #- Broj REACH registracije

vPvB = Vrlo otporno i vrlo bioakumulativno

Cijeli tekst skraćenih R

oznaka

:

R 22 Štetno ako se proguta

R 34 Izaziva opekotine

R 36/38 Nadražuje oči i kožu

R 43 U dodiru s kožom može izazvati preosjetljivost

R 50 Vrlo otrovno za organizme koji žive u vodi

R50/53 Vrlo otrovno za organizme koji žive u vodi, može dugotrajno štetno djelovati

u vodi

R 51/53 Otrovno za organizme koji žive u vodi, može dugotrajno štetno djelovati u

vodi

:

Cijeli tekst klasifikacija

[DSD/DPD]

Cijeli tekst skraćenih H

iskaza

:

Cijeli tekst klasifikacija

[CLP/GHS]

:

H302

Štetno ako se proguta.

H314

Uzrokuje teške opekline kože i ozljede oka.

H315

Nadražuje kožu.

H317

Može izazvati alergijsku reakciju na koži.

H319

Uzrokuje jako nadraživanje oka.

H400

Vrlo otrovno za vodeni okoliš.

H411

Otrovno za vodeni okoliš s dugotrajnim učincima.

H412

Štetno za vodeni okoliš s dugotrajnim učincima.

Acute Tox. 4, H302

akutno trovanje: ORALNO - Kategorija 4

Aquatic Acute 1, H400

VODENA TOKSIČNOST (AKUTNO) - Kategorija 1

Aquatic Chronic 2, H411

VODENA TOKSIČNOST (KRONIČNO) - Kategorija 2

Aquatic Chronic 3, H412

VODENA TOKSIČNOST (KRONIČNO) - Kategorija 3

Eye Irrit. 2, H319

ozbiljne ozljede očiju/NADRAŽUJE OČI - Kategorija 2

Skin Corr. 1B, H314

nagrizanje kože/nadražaj - Kategorija 1B

Skin Irrit. 2, H315

nagrizanje kože/nadražaj - Kategorija 2

Skin Sens. 1, H317

kožna osjetljivost - Kategorija 1

C - Nagrizajuće

Xn - Štetno

Xi - Nadražajuće

N - Opasno za okoliš

Datum izdanja/Datum revizije

:

12/13

21 siječnja 2014

HZTA

:

Nema.

Klercide-CR Biocide X Unit Dose Concentrate

ODJELJAK 16: Ostale informacije

Datum izdanja/ Datum

revizije

Izdanje

Informacije navedene u ovom dokumentu smatraju se vjerodostojnima s obzirom na pravila korištena u

proizvodnji sredstava u zemlji porijekla.

Napomena

Datum prethodnog izdanja

:

:

:

21 siječnja 2014

Nema prethodnih validacija

Datum izdanja/Datum revizije

:

13/13

21 siječnja 2014

HZTA

:

Nema.

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Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

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

23-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

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

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

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

7-8-2018

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

3-8-2018

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical ...

FDA - U.S. Food and Drug Administration

2-8-2018

Orphan designation:  Lenalidomide,  for the: Treatment of diffuse large B-cell lymphoma

Orphan designation: Lenalidomide, for the: Treatment of diffuse large B-cell lymphoma

On 13 May 2011, orphan designation (EU/3/11/868) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of diffuse large B-cell lymphoma.

Europe - EMA - European Medicines Agency

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

23-7-2018

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

FDA - U.S. Food and Drug Administration

21-7-2018

GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels "

GiftTree Issues Allergy Alert on Undeclared Pecans, Walnuts, Almonds, Peanuts in " Sherman Candy Caramels "

GiftTree, a gift basket company based in Vancouver, WA, is voluntarily recalling 94,000 units of “Sherman Candy Caramels” sold online in the several Gift Baskets because they may contain undeclared pecans, walnuts, almonds and/or peanuts. People who have an allergy or severe sensitivity to these nuts run the risk of serious or life-threatening reaction if they consume this product.

FDA - U.S. Food and Drug Administration

19-7-2018

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery Issues Allergy Alert on Undeclared Soy in Seattle Sourdough Pub Buns and Franz Premium Pub Buns

Portland French Bakery of Portland, OR is recalling 26,635 units of Seattle Sourdough Pub Bun 6pk and 8,022 units of Franz Premium Pub Buns 12pk, because it may contain undeclared SOY. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

13-7-2018

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

AZ Firm Issues Voluntary Product Recall Due to Undeclared Peanuts in Superfood Salad

Papa John’s Salads and Produce of Tolleson, AZ is voluntarily recalling 148 units of the Superfood Salads due to misbranding and undeclared peanuts. The product contains peanuts which are not declared on the product label as packages of peanuts were mistakenly included in the kits instead of cashews.

FDA - U.S. Food and Drug Administration

3-7-2018

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns

United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

21-10-2018

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.

FDA - U.S. Food and Drug Administration

21-10-2018

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most trea

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most trea

Also, while most of FDA’s women’s health initiatives are product specific, the #FDA plays an outsize role when it comes to mammography, which produces low-dose x-ray picture of the breast – an important tool to detect breast cancer in its early, most treatable stages. pic.twitter.com/aoYjsSEPrC

FDA - U.S. Food and Drug Administration

18-10-2018

Sutent (Pfizer Europe MA EEIG)

Sutent (Pfizer Europe MA EEIG)

Sutent (Active substance: sunitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6922 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/687/T/72

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

17-9-2018

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid use disorder. #FDA

FDA - U.S. Food and Drug Administration

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

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

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

7-8-2018

Research: Software as a Medical Device and Cyber Security for Medical Devices

Research: Software as a Medical Device and Cyber Security for Medical Devices

Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance

Therapeutic Goods Administration - Australia

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

27-7-2018

Withdrawn application:  Sutent, sunitinib, Post-authorisation

Withdrawn application: Sutent, sunitinib, Post-authorisation

Europe - EMA - European Medicines Agency

16-7-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9  pic.twitter.com/kT7EqyTPxr

FDA - U.S. Food and Drug Administration

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments: https://go.usa.gov/xQ7Jb  pic.twitter.com/hQxiKdMZBK

FDA - U.S. Food and Drug Administration

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency