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Lokalizacija

  • Na raspolaganju u:
  • ECO-CLIN TABS -88 (913131)
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 113574E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

SIGURNOSNO -TEHNIČKI LIST

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ODJELJAK 1. IDENTIFIKACIJA TVARI/SMJESE I PODACI O TVRTKI/PODUZEĆU

1.1 Identifikacijska oznaka proizvoda

Ime proizvoda

Eco-Clin Tabs -88

Oznaka proizvoda

113574E

Uporaba tvari/pripravka

Sredstvo za strojno pranje posuđa

Vrsta tvari

Smjesa

Samo za profesionalne korisnike.

Informacije o razrijeđenom

proizvodu

Nema informacija za razrijeđenje

1.2 Relevantne identificirane uporabe tvari ili smjese i uporabe koje se ne preporučuju

Identificirane uporabe

Sredstvo za pranje i ispiranje u perilicama posuđa/automatski

postupak

Preporučena ograničenja u

svezi s uporabom

Ograničeno za industrijsku i profesionalnu uporabu.

1.3 Podaci o dobavljaču koji isporučuje sigurnosno-tehnički list

Proizvođač

Ecolab d.o.o.

Zavrtnica 17

10 000, Zagreb Hrvatska 01 632 1600 (radno vrijeme 8-16 h)

dijana.kovacic@ecolab.com

1.4 Broj telefona službe za izvanredna stanja

Broj telefona službe za

izvanredna stanja

+38518000010

+32-(0)3-575-5555 Trans-europski

Broj telefona za medicinske

informacije:

01-23-48-342 (Medicinske Info)

Datum sakupljanja/revizije

04.09.2017

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari ili smjese

Razvrstavanje (prema uredbi (EZ) br. 1272/2008 (CLP))

Ozljeda oka, klasa 1

H318

Kronična toksičnost u vodenom okolišu, Klasa 3

H412

2.2 Elementi označivanja

Označivanje naljepnicom (prema uredbi (EZ) br. 1272/2008 (CLP))

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Piktogrami opasnosti

Oznaka opasnosti

Opasnost

Oznake upozorenja

H318

Uzrokuje teške ozljede oka.

H412

Štetno za vodeni okoliš s dugotrajnim

učincima.

Oznake obavijesti

Sprječavanje:

P273

Izbjegavati ispuštanje u okoliš.

P280

Nosite zaštitu za oči / zaštitu za lice.

Postupanje:

P305 + P351 + P338

U SLUČAJU DODIRA S OČIMA: oprezno

ispirati vodom nekoliko minuta. Ukloniti

kontaktne leće ukoliko ih nosite i ako se one

lako uklanjaju. Nastaviti ispiranje.

P310

Odmah nazvati CENTAR ZA KONTROLU

OTROVANJA/liječnika.

Opasne tvari koje se moraju navesti na naljepnici:

Natrij-perkarbonat

dinatrijev disilikat

Dodatno označavanje:

Izvanredno označivanje

naljepnicom posebnih

preparata

Sadrži: amylase, α-, subtilisin, Može prouzročiti alergijsku reakciju.

2.3 Ostale opasnosti

Nisu poznati.

ODJELJAK 3. SASTAV/INFORMACIJE O SASTOJCIMA

3.2 Smjese

Opasni sastojci

Kemijski naziv

CAS-br.

EZ-br.

Br. REACH

Razvrstavanjeprema uredbi (EZ) br.

1272/2008 (CLP)

Koncentracija:

natrijkarbonat(soda)

497-19-8

207-838-8

01-2119485498-19

Nadražaj očiju Klasa 2; H319

>= 25 - < 30

Natrij-perkarbonat

15630-89-4

239-707-6

01-2119457268-30

Oksidirajuće krutine Klasa 3; H272

Akutna toksičnost Klasa 4; H302

Ozljeda oka klasa 1; H318

>= 10 - < 20

dinatrijev disilikat

13870-28-5

Akutna toksičnost Klasa 4; H332

Ozljeda oka klasa 1; H318

>= 3 - < 5

alkiletoksi-propoksilati

120313-48-6

Nadraž. koža Klasa 2; H315

Ozljeda oka klasa 1; H318

Ak.toks.vod.okol. klasa 1; H400

Kronična toksičnost u vodenom okolišu

Klasa 3; H412

>= 1 - < 2.5

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HEDP.Na2

29329-71-3

Akutna toksičnost Klasa 4; H302

>= 1 - < 2.5

amylase, α-

9000-90-2

232-565-6

Osjetljivost dišnog sustava klasa 1;

H334

>= 0.5 - < 1

Zinc sulphate

7446-19-7

Akutna toksičnost Klasa 4; H302

Ozljeda oka klasa 1; H318

Ak.toks.vod.okol. klasa 1; H400

Kronična toksičnost u vodenom okolišu

klasa 1; H410

>= 0.5 - < 1

subtilisin

9014-01-1

232-752-2

01-2119480434-38

Nadraž. koža Klasa 2; H315

Ozljeda oka klasa 1; H318

Osjetljivost dišnog sustava klasa 1;

H334

Specifična toksičnost za ciljne

organe/sustavna toksičnost -

jednokratna izloženost Klasa 3; H335

>= 0.1 - < 0.25

Tvari s ograničenjem izlaganja na radnom mjestu :

glicerin

56-81-5

200-289-5

>= 0.1 - < 0.25

Za puni tekst H-izjava navedenih u ovom odjeljku pogledajte odjeljak 16.

ODJELJAK 4. MJERE PRVE POMOĆI

4.1 Opis mjera prve pomoći

U slučaju dodira s očima

Odmah početi ispirati s puno vode, također ispod očnih kapaka, u

trajanju od najmanje 15 minuta. Ukloniti kontaktne leće ako ih

nosite i ako se one lako uklanjaju. Nastaviti ispiranje. Odmah

pozovite liječnika.

U slučaju dodira s kožom

Isprati s mnogo vode.

U slučaju gutanja

Isprati usta. Ako se pojave simptomi, potražiti liječničku pomoć.

U slučaju inhalacije

Premjestiti na svjež zrak. Liječiti simptomatski. Ako se pojave

simptomi, potražiti liječničku pomoć.

4.2 Najvažniji simptomi i učinci, akutni i odgođeni

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

4.3 Navod o slučaju potrebe za hitnom liječničkom pomoći i posebnom obradom

Liječenje

Liječiti simptomatski.

ODJELJAK 5. MJERE GAŠENJA POŽARA

5.1 Sredstva za gašenje

Prikladna sredstva za

gašenje

Upotrijebiti mjere suzbijanja požara koje odgovaraju lokalnim

okolnostima i okolnom ambijentu.

Neprikladna sredstva za

gašenje požara

Nisu poznati.

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5.2 Posebne opasnosti koje proizlaze iz tvari ili smjese

Posebne opasnosti tijekom

suzbijanja požara

Nije zapaljivo niti lako zapaljivo.

Opasni proizvodi izgaranja

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljikovi oksidi

Dušikovi oksidi (NOx)

sumporni oksidi

Fosforovi oksidi

5.3 Savjeti za gasitelje požara

Posebna zaštitna oprema za

vatrogasce

: Koristiti osobnu zaštitnu opremu.

Dodatni podaci

: S požarnim ostacima i vodom koja se koristila za gašenje požara

mora se rukovati u skladu s lokalnim uredbama. U slučaju požara

i/ili eksplozije, ne udisati dimove.

ODJELJAK 6. MJERE KOD SLUČAJNOG ISPUŠTANJA

6.1 Osobne mjere opreza, zaštitna oprema i postupci za izvanredna stanja

Savjet za osoblje koje ne

intervenira u hitnim

slučajevima

Osigurati odgovarajuću ventilaciju. Držati ljude podalje i nasuprot

vjetru u odnosu na prolivenu tekućinu/pukotinu iz koje curi.

Izbjegavati udisanje, gutanje i dodir s kožom te očima. Ukoliko se

radnici susreću s količinama većim od graničnih vrijednosti

izloženosti, moraju koristiti odgovarajuće provjerene respiratore.

Osigurajte da čišcenje obavlja samo stručno osoblje. Pogledati

mjere zaštite navedene u odsjecima 7 i 8.

Savjet za osoblje koje

intervenira u hitnim

slučajevima

Ako je specijalizirana odjeća potrebna za rješavanje izlijevanja,

treba obratiti pažnju na bilo kakve informacije u Odjeljku 8 o

prikladnim i neprikladnim materijalima.

6.2 Mjere zaštite okoliša

Mjere zaštite okoliša

Ne dozvolite dodir s tlom, površinskim ili podzemnim vodama.

6.3 Metode i materijal za sprečavanje širenja i čišćenje

Metodama čišćenja

Pomesti i odložiti u odgovarajuće spremnike za odlaganje.

6.4 Uputa za druge odjeljke

Vidjeti Odjeljak 1 za konakt za hitne informacije.

Za osobnu zaštitu pogledati odsjek 8.

Vidjeti Odjeljak 13 za dodatne informacije o zbrinjavanju otpada.

ODJELJAK 7. RUKOVANJE I SKLADIŠTENJE

7.1 Mjere opreza za sigurno rukovanje

Savjeti za sigurno rukovanje

Spriječiti dodir s očima, kožom ili odjećom. Ne udisati prašinu/

dim/ plin/ maglu/ pare/ aerosol. Rabiti samo uz odgovarajuću

ventilaciju. Nakon uporabe temeljito oprati ruke

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

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sigurnosnom praksom. Skinuti i oprati kontaminiranu odjeću prije

ponovnog korištenja. Nakon rukovanja temeljito oprati lice, ruke i

izloženu kožu. Osigurati odgovarajući prostor za brzo namakanje

ili ispiranje očiju i tijela u slučaju kontakta ili prskanja opasnim

kemikalijama

7.2 Uvijeti sigurnog skladištenja, uzimajući u obzir moguće inkompatibilnosti

Uvjeti skladišnih prostora i

spremnika

Čuvati izvan dohvata djece. Čuvati u dobro zatvorenom

spremniku. Čuvati na suhom, hladnom mjestu. Pohranjujte u

primjerenim obilježenim spremnicima.

Čuvati izvan dohvata djece. Čuvati u dobro zatvorenom

spremniku. Pohranjujte u primjerenim obilježenim spremnicima.

Temperatura skladištenja

0 °C do 30 °C

7.3 Posebna krajnja uporaba ili uporabe

Posebna uporaba

Sredstvo za pranje i ispiranje u perilicama posuđa/automatski

postupak

ODJELJAK 8. NADZOR NAD IZLOŽENOŠĆU/OSOBNA ZAŠTITA

8.1 Nadzorni parametri

Ograničenja kod profesionalnog izlaganja

Sastojci

CAS-br.

Vrsta vrijednosti

(Oblik izloženosti)

Nadzorni parametri

Temelj

subtilisin

9014-01-1

0.00004 mg/m3

HR OEL

Dodatni podaci

Senzibilizacija

ŠTETNO

glicerin

56-81-5

10 mg/m3

HR OEL

DNEL

natrijkarbonat(soda)

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 10 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Akutni lokalni učinci

Vrijednost: 10 mg/m3

8.2 Nadzor nad izloženošću

Odgovarajući inženjerski mehanizmi

Tehničke mjere

Djelotvoran odvodno ventilacijski sustav. Održavati vrijednosti

koncentracija u zraku unutar normi za granične vrijednosti

izloženosti na radu.

Individualne mjere zaštite

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

sigurnosnom praksom. Skinuti i oprati kontaminiranu odjeću prije

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ponovnog korištenja. Nakon rukovanja temeljito oprati lice, ruke i

izloženu kožu. Osigurati odgovarajući prostor za brzo namakanje

ili ispiranje očiju i tijela u slučaju kontakta ili prskanja opasnim

kemikalijama

Zaštita očiju/lica (EN 166)

Zaštitne naočale

Stitnik za lice

Zaštita ruku (EN 374)

Nije potrebna posebna zaštitna oprema.

Zaštita kože i tijela (EN

14605)

Nije potrebna posebna zaštitna oprema.

Zaštita organa za disanje

(EN 143, 14387)

Kad se respiratorni rizici ne mogu izbjeći ili nisu dovoljno

ograničeni tehničkim sredstvima kolektivne zaštite ili mjerama,

metodama ili procedurama organizacije rada, razmotriti upotrebu

certificirane opreme za zaštitu respiratornog trakta, ispunjavanje

uvjeta EU (89/656 / EEZ, 89/686 / EEZ) , ili ekvivalenta, s tipom

filtra:

Nadzor nad zaštitom okoliša

Opći savjeti

: Osigurajte okolicu mjesta pohrane.

ODJELJAK 9. FIZIKALNA I KEMIJSKA SVOJSTVA

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Agregatno stanje

: tableta

Boja

: bjelo sa obojanim dijelovima

Miris

: limun

10.3 - 11.3, 1 %

Plamište

Nije primjenjivo, Ne potpomaže izgaranje.

Prag osjetljivosti mirisa

Ne može se primijeniti i /ili odrediti iz mješavine

Točka topljenja/Točka

topljenja

Ne može se primijeniti i /ili odrediti iz mješavine

Početna točka vrenja i

raspon vrenja

Ne može se primijeniti i /ili odrediti iz mješavine

Hlapivost

Ne može se primijeniti i /ili odrediti iz mješavine

Zapaljivost (kruta tvar, plin)

Ne može se primijeniti i /ili odrediti iz mješavine

Gornja granica

eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Donja granica eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Tlak pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća

1.5 - 1.54

Topljivost u vodi

topivo

Topivost u drugim

Ne može se primijeniti i /ili odrediti iz mješavine

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sredstvima za otapanje

Koeficijent raspodjele n-

oktanol/voda

Ne može se primijeniti i /ili odrediti iz mješavine

Temperatura

samozapaljenja

Ne može se primijeniti i /ili odrediti iz mješavine

Termička razgradnja

Ne može se primijeniti i /ili odrediti iz mješavine

Viskoznost, kinematička

Ne može se primijeniti i /ili odrediti iz mješavine

Eksplozivna svojstva

Ne može se primijeniti i /ili odrediti iz mješavine

Oksidirajuća svojstva

9.2 Ostale informacije

Ne može se primijeniti i /ili odrediti iz mješavine

ODJELJAK 10. STABILNOST I REAKTIVNOST

10.1 Reaktivnost

Nisu poznate opasne reakcije u uvjetima uobičajene uporabe.

10.2 Kemijska stabilnost

Stabilno u normalnim uvjetima.

10.3 Mogućnost opasnih reakcija

Nisu poznate opasne reakcije u uvjetima uobičajene uporabe.

10.4 Uvjeti koje treba izbjegavati

Nisu poznati.

10.5 Inkompatibilni materijali

Kiseline

10.6 Opasni proizvodi raspadanja

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljikovi oksidi

Dušikovi oksidi (NOx)

sumporni oksidi

Fosforovi oksidi

ODJELJAK 11. TOKSIKOLOŠKE INFORMACIJE

11.1 Informacije o toksikološkim učincima

Informacije o vjerojatnim

načinima izlaganja

Dodir s očima, Dodir s kožom

Proizvod

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Akutna oralna toksičnost

: Procjena akutne toksičnosti : > 2,000 mg/kg

Akutna toksičnost pri

udisanju

: 4 h Procjena akutne toksičnosti : > 5 mg/l

Akutna kožna toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Nadraživanje i nagrizanje

kože

: Nema raspoloživih podataka o ovom proizvodu.

Ozbiljno oštećenje

oka/nadraživanje oka

: Nema raspoloživih podataka o ovom proizvodu.

Senzibilizacija kože ili dišnih

puteva

: Nema raspoloživih podataka o ovom proizvodu.

Karcinogenost

: Nema raspoloživih podataka o ovom proizvodu.

Učinci na razmnožavanje

: Nema raspoloživih podataka o ovom proizvodu.

Mutagenost zametnih stanica

: Nema raspoloživih podataka o ovom proizvodu.

Teratogenost

: Nema raspoloživih podataka o ovom proizvodu.

Specifična toksičnost za

ciljne organe/sustavna

toksičnost (jednokratna

izloženost)

: Nema raspoloživih podataka o ovom proizvodu.

Specifična toksičnost za

ciljne organe/sustavna

toksičnost (opetovana

izloženost)

: Nema raspoloživih podataka o ovom proizvodu.

Aspiracijska toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Sastojci

Akutna oralna toksičnost

: natrijkarbonat(soda)

LD50 Štakor: 2,800 mg/kg

Natrij-perkarbonat

LD50 Štakor: 1,034 mg/kg

dinatrijev disilikat

LD50 Štakor: 2,000 mg/kg

HEDP.Na2

LD50 Štakor: 1,166 mg/kg

amylase, α-

LD50 Štakor: 5,000 mg/kg

Zinc sulphate

LD50 Štakor: 1,710 mg/kg

subtilisin

LD50 Štakor: 1,800 mg/kg

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glicerin

LD50 Štakor: 18,300 mg/kg

Sastojci

Akutna toksičnost pri

udisanju

: dinatrijev disilikat

4 h LC50 Štakor: 3.51 mg/l

amylase, α-

4 h LC50 Štakor: 4.96 mg/l

Sastojci

Akutna kožna toksičnost

: HEDP.Na2

LD50 Zec: 7,940 mg/kg

glicerin

LD50 Zec: 23,000 mg/kg

Potencijalno djelovanje na zdravlje

Oči

Uzrokuje teške ozljede oka.

Koža

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Gutanje

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Inhalacija

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Kronično izlaganje

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Iskustvo s izlaganjem ljudi

Dodir s očima

Crvenilo, Bol, Nagrizanje

Dodir s kožom

Nisu poznati ili očekivani nikakvi simptomi.

Gutanje

Nisu poznati ili očekivani nikakvi simptomi.

Inhalacija

Nisu poznati ili očekivani nikakvi simptomi.

ODJELJAK 12. EKOLOŠKE INFORMACIJE

12.1 Toksičnost

Utjecaj na okoliš

Štetno za vodeni okoliš s dugotrajnim učincima.

Proizvod

Otrovnost za ribe

: Nema raspoloživih podataka

Toksično za daphnia i ostale

vodene beskičmenjake.

: Nema raspoloživih podataka

Otrovnost za alge

: Nema raspoloživih podataka

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Sastojci

Otrovnost za ribe

: natrijkarbonat(soda)

96 h LC50 Lepomis macrochirus (Plavoškrga sunčanica): 300

mg/l

alkiletoksi-propoksilati

96 h LC50 Brachydanio rerio (riba zebra): 0.55 mg/l

HEDP.Na2

96 h LC50 Ribe: 1,925 mg/l

Zinc sulphate

96 h LC50: 1.359 mg/l

glicerin

96 h LC50 Ribe: 855 mg/l

Sastojci

Toksično za daphnia i ostale

vodene beskičmenjake.

: natrijkarbonat(soda)

48 h EC50 Ceriodaphnia (vodenbuha): 213.5 mg/l

Natrij-perkarbonat

48 h EC50 Daphnia (Dafnija- planktonski račić): 4.9 mg/l

dinatrijev disilikat

48 h EC50: 491 mg/l

alkiletoksi-propoksilati

48 h EC50: 55 mg/l

HEDP.Na2

48 h EC50: 3,200 mg/l

subtilisin

48 h EC50: 1.4 mg/l

Sastojci

Otrovnost za alge

: alkiletoksi-propoksilati

72 h EC50: 0.5 mg/l

HEDP.Na2

14 d NOEC: 13 mg/l

amylase, α-

72 h EC50: 112 mg/l

12.2 Postojanost i razgradivost

Proizvod

Nema raspoloživih podataka

Sastojci

Biorazgradljivost

natrijkarbonat(soda)

Rezultat: Nije primjenjivo - anorganski

Natrij-perkarbonat

SIGURNOSNO -TEHNIČKI LIST

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Rezultat: Nije primjenjivo - anorganski

dinatrijev disilikat

Rezultat: Nije primjenjivo - anorganski

alkiletoksi-propoksilati

Rezultat: Biološki vrlo razgradljivo.

HEDP.Na2

Rezultat: Slabo biorazgradljivo

amylase, α-

Rezultat: Biološki vrlo razgradljivo.

Zinc sulphate

Rezultat: Nije primjenjivo - anorganski

subtilisin

Rezultat: Biološki vrlo razgradljivo.

glicerin

Rezultat: Biološki vrlo razgradljivo.

12.3 Bioakumulacijski potencijal

Nema raspoloživih podataka

12.4 Pokretljivost u tlu

Nema raspoloživih podataka

12.5 Rezultati ocjenjivanja svojstava PBT i vPvB

Proizvod

Ocjena

Ova tvar/smjesa ne sadrži komponente koje se smatraju

postojanim, bioakumulirajućima i toksičnima (PBT), ili jako

postojanim i jako bioakumulirajućima (VPvB) na razinama od

0.1% ili više.

12.6 Ostali štetni učinci

Nema raspoloživih podataka

ODJELJAK 13. ZBRINJAVANJE

Odlažite u skladu s europskim direktivama o otpadu i opasnom otpadu.Kodove otpada bi trebao

odrediti korisnik, po mogućnosti u dogovoru s nadležnim organima za zbrinjavanje otpada.

13.1 Metode obrade otpada

Proizvod

: Proizvod ne smije ući u odvodne kanale, izvore vode ili tlo. Uvijek

kada je moguće se preferira recikliranje od odlaganja ili

spaljivanja. Ukoliko se ne može sprovesti recikliranje, odlagati u

skladu s lokalnim uredbama. Otpad odlažite na ovlaštena

odlagališta namijenjena toj svrsi.

Kontaminirana ambalaža

: Odlagati kao neupotrijebljen proizvod. Prazne spremnike treba

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dostaviti ovlaštenoj osobi za postupanje s otpadom na recikliranje

ili odlaganje. Prazni spremnici se ne smiju ponovno upotrebljavati.

Odložite u skladu s mjesnim, državnim i federalnim propisima.

Smjernice za izbor koda za

otpad

: Anorganski otpad koji sadrži opasne tvari. Ako se ovaj proizvod

koristi u bilo kojem daljnjem postupku, konačni korisnik mora

redefinirati i dodijeliti najprikladniji kôd kataloga otpada.

Odgovornost generatora otpada je da odredi toksičnost i fizikalna

svojstva materijala koji se generira kako bi se odredile

odgovarajuće metode identifikacije i odlaganja otpada sukladno

važećim europskim (EU Directive 2008/98 / EC) i lokalnim

propisima.

ODJELJAK 14. INFORMACIJE O PRIJEVOZU

Pošiljatelj je odgovoran osigurati da pakiranje, etiketiranje i obilježavanje je u skladu sa odabranim

načinom prijevoza.

Kopneni prijevoz (ADR/ADN/RID)

14.1 UN broj

Bezopasna roba

14.2 Pravilno otpremno ime

prema UN-u

Bezopasna roba

14.3 Razred(i) opasnosti pri

prijevozu

Bezopasna roba

14.4 Skupina pakiranja

Bezopasna roba

14.5 Opasnosti za okoliš

Bezopasna roba

14.6 Posebne mjere opreza

za korisnike

Bezopasna roba

Zračni prijevoz (IATA)

14.1 UN broj

Bezopasna roba

14.2 Pravilno otpremno ime

prema UN-u

Bezopasna roba

14.3 Razred(i) opasnosti pri

prijevozu

Bezopasna roba

14.4 Skupina pakiranja

Bezopasna roba

14.5 Opasnosti za okoliš

Bezopasna roba

14.6 Posebne mjere opreza

za korisnike

Bezopasna roba

Morski prijevoz (IMDG/IMO)

14.1 UN broj

Bezopasna roba

14.2 Pravilno otpremno ime

prema UN-u

Bezopasna roba

14.3 Razred(i) opasnosti pri

prijevozu

Bezopasna roba

14.4 Skupina pakiranja

Bezopasna roba

14.5 Opasnosti za okoliš

Bezopasna roba

14.6 Posebne mjere opreza

za korisnike

Bezopasna roba

14.7 Prijevoz u razlivenom

stanju u skladu s Prilogom II.

Konvenciji MARPOL i

Kodeksom IBC

Bezopasna roba

SIGURNOSNO -TEHNIČKI LIST

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ODJELJAK 15. INFORMACIJE O PROPISIMA

15.1 Propisi u području sigurnosti, zdravlja i okoliša/posebno zakonodavstvo za tvar ili smjesu

sukladno Uredbi o

deterdžentima EZ 648/2004

30% i više: Fosfati

15% ili više, ali manje od 30%: Sredstva za izbjeljivanje bazirana

na kisiku

manje od 5%: Neionski tenzidi, Polikarboksilati

Drugi sastojci: Enzimi, Parfemi

Alergeni:

Limonen

Nacionalni propisi

Obratiti pažnju na Direktivu 94/33/EZ o zaštiti mladih ljudi na poslu.

Druge uredbe

Zakon o kemikalijama, Pravilnik 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,

Pravilnik o popisu aktivnih tvari u biocidnim pripravcima, Pravilnik

o popisu postojećih aktivnih tvari dopuštenih u biocidnim

pripravcima, Pravilnik o popisu postojećih aktivnih tvari koje nisu

dopuštene u biocidnim pripravcima, 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.

15.2 Procjena kemijske sigurnosti

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

ODJELJAK 16. OSTALE INFORMACIJE

Postupak se koristio za razvrstavanje prema

prema uredbi (EZ) br. 1272/2008 (CLP)

Razvrstavanje

Opravdanje

Ozljeda oka 1, H318

Način izračuna

Kronična toksičnost u vodenom okolišu 3, H412

Način izračuna

Cjelovit tekst H-izjava

H272

Može pojačati požar; oksidans.

H302

Štetno ako se proguta.

H315

Nadražuje kožu.

H318

Uzrokuje teške ozljede oka.

H319

Uzrokuje jako nadraživanje oka.

H332

Štetno ako se udiše.

H334

Ako se udiše može izazvati simptome alergije ili astme ili poteškoće s

disanjem.

H335

Može nadražiti dišni sustav.

H400

Vrlo otrovno za vodeni okoliš.

H410

Vrlo otrovno za vodeni okoliš, s dugotrajnim učincima.

H412

Štetno za vodeni okoliš s dugotrajnim učincima.

Cjelovit tekst ostalih skraćenica

SIGURNOSNO -TEHNIČKI LIST

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ADN - Europskog sporazuma o međunarodnom prijevozu opasnih tvari unutarnjim plovnim

putovima; ADR - Europski sporazum o međunarodnom cestovnom prijevozu opasnih tvari; AICS -

Australijski popis kemijskih tvari; ASTM - Američko društvo za ispitivanje materijala; bw - Tjelesna

masa; CLP - Klasifikacija uredbe o označavanju ambalaže; Uredba (EC) br. 1272/2008; CMR -

Kancerogen,

mutagen

reproduktivni

otrov;

Standard

Njemačkog

instituta

standardizaciju; DSL - Popis domaćih tvari (Kanada); ECHA - Europska agencija za kemikalije;

EC-Number - Broj Europske zajednice; ECx - Koncentracija povezana s x% odgovorom; ELx -

Stopa učitavanja povezana s x% odgovorom; EmS - Hitni raspored; ENCS - Postojeće i nove

kemijske tvari (Japan); ErCx - Koncentracija povezana s x% stopom rasta odgovora; GHS -

Globalno usklađen sustav; GLP - Dobra laboratorijska praksa; IARC - Međunarodna agencija za

istraživanje raka; IATA - Međunarodna udruga za zračni prijevoz; IBC - Međunarodni kodeks za

gradnju i opremanje brodova koji prevoze opasne kemikalije u rasutom stanju; IC50 - Pola

maksimalne koncentracije inhibitora; ICAO - Međunarodna organizacija za civilno zrakoplovstvo;

IECSC - Popis postojećih kemijskih tvari u Kini; IMDG - Međunarodni pomorski pravilnik za

prijevoz opasnih tvari; IMO - Međunarodna pomorska organizacija; ISHL - Zakon o industrijskoj

sigurnosti i zdravlju (Japan); ISO - Međunarodna organizacija za standardizaciju; KECI - Popis

postojećih kemikalija Koreje; LC50 - Smrtonosna koncentracija za 50% testirane populacije; LD50

Smrtonosna

doza

testirane

populacije

(Srednja

smrtonosna

doza);

MARPOL

Međunarodna konvencija o sprječavanju onečišćenja s brodova; n.o.s.

- Koji nije definiran

drugačije;

NO(A)EC

Nije

promatrana

(negativan)

koncentracija

učinka;

NO(A)EL

Nije

promatrano (negativan) razina učinka; NOELR - Nije primjetan učinak stope učitavanja; NZIoC -

Popis kemikalija Novog Zelanda; OECD - Organizacija za ekonomsku suradnju i razvoj; OPPTS -

Ured kemijske sigurnosti i sprječavanja onečišćenja; PBT - Postojana, bioakumulativna i otrovna

tvar; PICCS - Popis kemikalija i kemijskih tvari Filipina; (Q)SAR - (Kvantitativno) Struktura

aktivnosti odnosa; REACH - Uredba (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o

registriranju, ocjenjivanju, odobravanju i ograničavanju kemikalija; RID - Propisi o međunarodnom

prijevozu opasnih tvari željeznicom; SADT - Samoubrzanje temperature raspadanja; SDS -

Sigurnosni podatkovni list; TCSI - Popis kemijskih tvari Tajvana; TRGS - Tehnička pravila za

opasne tvari; TSCA - Zakon o kontroli otrovnih tvari (SAD); UN - Ujedinjene nacije; vPvB - Vrlo

postojani i vrlo bioakumulacijski

Pripremio

Poslovi vezani za zakonske propise

Brojevi navedeni u sigurnosnim listama (MSDS) dani su u obliku: 1,000 ,000 = 1 miljun and 1,000

= 1 tisuća. 0.1 = 1 destinka i 0.001 = 1 tisucinka.

PREPRAVLJENI PODACI: Znatne promjene zdravstvenih podataka za ovu reviziju su obilježene

na lijevoj margini MSDS-a.

Podaci u ovom sigurnosno-tehničkom listu odgovaraju našim saznanjima, informacijama i

uvjerenjima na dan izdavanja istog. Informacije sadržane u njemu, dane su samo kao smjernice

za sigurno rukovanje, upotrebu, postupanje, skladištenje, prijevoz i odlaganje otpada i nisu

garancija ili specifikacija kvalitete. Podaci se odnose isključivo na navedenu tvar/smjesu i nisu

nužno važeći za istu tu tvar/smjesu ukoliko se ista koristi sa bilo kojim drugim tvarima ili u bilo

kojem drugom postupku koji nije specificiran u tekstu.

  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.



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13-11-2018

FDA Publishes Design Recommendations for Residue Studies in Honey

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FDA - U.S. Food and Drug Administration

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

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Europe - EFSA - European Food Safety Authority Publications

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)

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11-10-2018

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

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10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

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Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

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29-8-2018

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

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28-8-2018

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23-8-2018

Third external evaluation of EFSA – progress made, recommendations for improvement

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7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

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6-8-2018

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30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

27-7-2018

Pending EC decision:  Xerava, eravacycline, Opinion date: 26-Jul-2018

Pending EC decision: Xerava, eravacycline, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

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

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

15-2-2018

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

Danish Medicines Agency

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

3-10-2014

Consultation procedure about medicinal products and safety measure requirements not completed yet

Consultation procedure about medicinal products and safety measure requirements not completed yet

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for...

Danish Medicines Agency

29-7-2014

Good laboratory practice in non-clinical trials

Good laboratory practice in non-clinical trials

Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.

Danish Medicines Agency

25-2-2014

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.

Danish Medicines Agency

5-1-2012

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

Danish Medicines Agency

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Medicines Agency

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

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

9-10-2018

#ICYMI - FDA issues recommendations to help prevent surgical fires and      related patient injury. Click the link to read the recommendations:  https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

FDA - U.S. Food and Drug Administration

1-10-2018

IONSYS (Incline Therapeutics Europe Ltd)

IONSYS (Incline Therapeutics Europe Ltd)

IONSYS (Active substance: fentanyl) - Centralised - Withdrawal - Commission Decision (2018)6412 of Mon, 01 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

21-8-2018

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months!  https://go.usa.gov/xUskq 
#OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCare pic.twitter.com/VRDkVPvMTR

FDA - U.S. Food and Drug Administration

15-8-2018

Scientific guideline:  Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open

The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005

Europe - EMA - European Medicines Agency

6-8-2018

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

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

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

Europe - EMA - European Medicines Agency

1-8-2018

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Pfizer Europe MA EEIG)

Tygacil (Active substance: Tigecycline) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5218 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/644/T/104

Europe -DG Health and Food Safety

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

Europe - EMA - European Medicines Agency

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

9-7-2018

Scientific guideline:  Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.

Europe - EMA - European Medicines Agency

29-6-2018

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts  http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

FDA - U.S. Food and Drug Administration

29-5-2018

FDA issues recommendations to help prevent surgical fires and related patient injury-  https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA - U.S. Food and Drug Administration