ECO-CLIN URINAL TABLETS

Glavna informacija

  • Trgovački naziv:
  • ECO-CLIN URINAL TABLETS
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj

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Lokalizacija

  • Na raspolaganju u:
  • ECO-CLIN URINAL TABLETS
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 113462E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br.

1907/2006

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

1.1 Identifikacija proizvoda

Ime proizvoda

Eco-clin urinal tablets

Oznaka proizvoda

113462E

Uporaba tvari/pripravka

Sredstvo za čišćenje sanitarija

Vrsta tvari

Smjesa

Samo za profesionalne korisnike.

Informacije o razrijeđenom

proizvodu

Nema informacija za razrijeđenje

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

Identificirane uporabe

Sredsrvo za čišćenje sanitarija. Ručno čišćenje

Preporučena ograničenja u

svezi s uporabom

Ograničeno za industrijsku i profesionalnu uporabu.

1.3 Podaci o dobavljaču sigurnosno-tehničkog lista

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

Telefonski broj Centra za

informacije o trovanju

01-23-48-342

Datum sakupljanja/revizije

09.07.2015

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari i smjese

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

Nadraž. koža, Klasa 2

H315

Ozljeda oka, Klasa 1

H318

Kronična vodena toksičnost, Klasa 3

H412

Razvrstavanje (prema direktivi (EZ) (67/548/EEZ), 1999/45/EZ)

Xn; ŠTETNO

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R52/53

Za cjelokupan sadržaj R upozorenja spomenutih u ovom odsjeku, pogledati odsjek 16.

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

2.2 Elementi označivanja prema Direktivi 1999/45/EZ ili Uredbi (EZ) br. 1272/2008 (CLP)

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

Piktogrami opasnosti

Oznaka opasnosti

Opasnost

Oznake upozorenja

H315

Nadražuje kožu.

H318

Uzrokuje teške ozljede oka.

H412

Štetno za vodeni okoliš s dugotrajnim

učincima.

Oznake obavijesti

Sprječavanje:

P273

Izbjegavati ispuštanje u okoliš.

P280

Nosite zaštitne rukavice/ 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:

ABS-Na

2.3 Ostale opasnosti

Ne miješati sa izbjeljivačima i ostalim kloriranim proizvodima - nastati će plinoviti klor.

ODJELJAK 3. SASTAV/INFORMACIJE O SASTOJCIMA

3.2 Smjese

Opasni sastojci

Kemijski naziv

CAS-br.

EZ-br.

Br. REACH

Razvrstavanje

(prema direktivi

(EZ)

(67/548/EEZ))

Razvrstavanje

(prema uredbi (EZ) br.

1272/2008 (CLP))

Koncentracija:

natrijkarbonat(soda)

497-19-8

207-838-8

01-2119485498-19

Xi; R36

Nadražaj očiju Klasa 2; H319

>= 30 - < 50

ABS-Na

68411-30-3

Xn-Xi; R22-

Akutna toksičnost Klasa 4;

>= 25 - < 30

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270-115-0

01-2119489428-22

R38-R41-

R52/53

H302

Nadraž. koža Klasa 2; H315

Ozljeda oka Klasa 1; H318

Kronična vodena toksičnost

Klasa 3; H412

alkiletersulfati

68891-38-3

500-234-8

01-2119488639-16

Xi; R38-R41

Nadraž. koža Klasa 2; H315

Ozljeda oka Klasa 1; H318

>= 3 - < 5

limunska kiselina

77-92-9

201-069-1

Xi; R36

Korozivno za metale Klasa 1;

H290

Nadražaj očiju Klasa 2; H319

>= 3 - < 5

otapala / aditivi

94266-48-5

304-455-9

Xn; R65

Xi; R36

N; R51/53

Nadražaj očiju Klasa 2; H319

Opasnost od udisanja Klasa

1; H304

Kronična vodena toksičnost

Klasa 1; H410

>= 1 - < 2.5

Za cjelokupan sadržaj R upozorenja spomenutih u ovom odsjeku, pogledati odsjek 16.

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

Odmah ispirati s mnogo vode u trajanju od barem 15 minuta. Ako

je moguće, upotrijebiti blag sapun. Ako se nadraženost razvije i ne

prestane, potražiti liječničku pomoć.

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 Hitna liječnička pomoć i posebna obrada

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.

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Neprikladna sredstva za

gašenje požara

Nisu poznati.

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 u slučaju opasnosti

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 kožom i očima Spriječiti dodir s očima, kožom ili

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odjećom. Ne udisati prašinu/dim/plin/maglu/pare/aerosol. Rabiti

samo uz odgovarajuću ventilaciju. Nakon uporabe temeljito oprati

ruke Ne miješati sa izbjeljivačima i ostalim kloriranim proizvodima

- nastati će plinoviti klor.

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

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. Pohranjujte u primjerenim obilježenim spremnicima.

Temperatura skladištenja

-5 °C do 40 °C

7.3 Posebna krajnja uporaba ili uporabe

Posebna uporaba

Sredsrvo za čišćenje sanitarija. Ručno čišćenje

ODJELJAK 8. NADZOR NAD IZLOŽENOŠĆU/OSOBNA ZAŠTITA

8.1 Nadzorni parametri

Ograničenja kod profesionalnog izlaganja

Ne sadrži tvari za koje su propisane granične vrijednosti profesionalne izloženosti.

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

ABS-Na

Konačna upotreba: Radnici

Načini izloženosti: Kožno

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 85 mg/cm2

Konačna upotreba: Radnici

Načini izloženosti: Kožno

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 85 mg/cm2

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 6 mg/m3

Konačna upotreba: Radnici

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Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 6 mg/m3

PNEC

ABS-Na

Slatka voda

Vrijednost: 0.268 mg/l

Morska voda

Vrijednost: 0.0268 mg/l

Isprekidano korištenje/otpuštanje

Vrijednost: 0.0167 mg/l

Talog u slatkoj vodi

Vrijednost: 8.1 mg/kg

Talog u moru

Vrijednost: 8.1 mg/kg

Postrojenje za obradu fekalija

Vrijednost: 3.43 mg/l

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

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)

Nosite sljedeću osobnu zaštitnu opremu:

Nitrilna guma

Butilna guma

Nepropusne rukavice

U slučaju bilo kakvih znakova razgradnje rukavica ili kemijskog

prodiranja kroz rukavice treba ih ukloniti i zamijeniti novim.

Zaštita kože i tijela (EN

14605)

Nije potrebna posebna zaštitna oprema.

Zaštita organa za disanje

(EN 143, 14387)

Nije potrebna ako su koncentracije ispod GVI vrijednosti Koristiti

certificiranuzaštitnu opremu za disanje koja prati EU zahtjeve

(89/656/EEZ, 89/686/EEZ) ili slično kada se respiratorni rizici ne

mogu izbjeći ili ograničiti tehničkim mjerama kolektivne zaštite ili

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mjerama, metodama i postupcima organizacije rada.

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

: krut

Boja

: svijetlo zelen

Miris

: blag

10.0 - 11.0, 1 %

Plamište

Nije primjenjivo

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

1.4 - 1.8

Topljivost u vodi

topivo

Topivost u drugim

sredstvima za otapanje

Ne može se primijeniti i /ili odrediti iz mješavine

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

Tvar ili mješavina nije klasificirana kao oksidirajuća.

9.2 Ostali podaci

Ne može se primijeniti i /ili odrediti iz mješavine

ODJELJAK 10. STABILNOST I REAKTIVNOST

10.1 Reaktivnost

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Nisu poznate opasne reakcije u uvjetima uobičajene uporabe.

10.2 Kemijska stabilnost

Stabilno u normalnim uvjetima.

10.3 Mogućnost opasnih reakcija

Ne miješati sa izbjeljivačima i ostalim kloriranim proizvodima - nastati će plinoviti klor.

10.4 Uvjeti koje treba izbjegavati

Nisu poznati.

10.5 Inkompatibilni materijali

Nisu poznati.

10.6 Opasni proizvodi raspada

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

Toksičnost

Akutna oralna toksičnost

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

Akutna toksičnost pri

udisanju

: Nema raspoloživih podataka o ovom proizvodu.

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.

Kancerogenost

: Nema raspoloživih podataka o ovom proizvodu.

Učinci na razmnožavanje

: Nema raspoloživih podataka o ovom proizvodu.

Mutagenost zametnih stanica

: Nema raspoloživih podataka o ovom proizvodu.

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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

ABS-Na

LD50 Štakor: 1,080 mg/kg

alkiletersulfati

LD50 Štakor: 3,350 mg/kg

limunska kiselina

LD50 Štakor: 11,700 mg/kg

otapala / aditivi

LD50 Štakor: 3,200 mg/kg

Sastojci

Akutna kožna toksičnost

: alkiletersulfati

LD50 Zec: 8,000 mg/kg

otapala / aditivi

LD50 Zec: > 5,000 mg/kg

Potencijalno djelovanje na zdravlje

Oči

Uzrokuje teške ozljede oka.

Koža

Uzrokuje iritaciju kože.

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

Crvenilo, Nadraživanje

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Gutanje

Nisu poznati ili očekivani nikakvi simptomi.

Inhalacija

Nisu poznati ili očekivani nikakvi simptomi.

ODJELJAK 12. EKOLOŠKE INFORMACIJE

12.1 Ekotoksičnost

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

Sastojci

Otrovnost za ribe

: natrijkarbonat(soda)

96 h LC50 Lepomis macrochirus (Plavoškrga sunčanica): 300

mg/l

ABS-Na

96 h LC50 Lepomis macrochirus (Plavoškrga sunčanica): 1.67

mg/l

alkiletersulfati

96 h LC50 Ribe: 7.1 mg/l

limunska kiselina

96 h LC50 Ribe: > 100 mg/l

Sastojci

Toksično za daphnia i ostale

vodene beskičmenjake.

: natrijkarbonat(soda)

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

ABS-Na

48 h LC50 Daphnia magna (Vodenbuha): 2.4 mg/l

Sastojci

Otrovnost za alge

: ABS-Na

96 h EC50 Pseudokirchneriella subcapitata (zelena alga): 29 mg/l

12.2 Postojanost i razgradivost

Proizvod

Biorazgradljivost

: Tenzidi u proizvodu su biorazgradljivi prema zahtjevima iz

regulativa o sredstvima za pranje 648/2004/EC.

Sastojci

Biorazgradljivost

natrijkarbonat(soda)

Rezultat: Nije primjenjivo

ABS-Na

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br. 1907/2006

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Rezultat: Biološki vrlo razgradljivo.

alkiletersulfati

Rezultat: Biološki vrlo razgradljivo.

limunska kiselina

Rezultat: Biološki vrlo razgradljivo.

otapala / aditivi

Rezultat: Nije primjenjivo

12.3 Bioakumulacijski potencijal

Nema raspoloživih podataka

12.4 Pokretljivost u tlu

Nema raspoloživih podataka

12.5 Rezultati procjene PBT i vPvB svojstava

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 postupanja s otpadom

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

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.

Europski katalog otpada

: 200129* - sredstva za pranje koja sadrže opasne tvari

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)

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br. 1907/2006

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14.1 UN broj

Bezopasna roba

14.2 Točan naziv pošiljke

UN-a

Bezopasna roba

14.3 Klasa(e) opasnosti

prijevoza

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 Točan naziv pošiljke

UN-a

Bezopasna roba

14.3 Klasa(e) opasnosti

prijevoza

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 Točan naziv pošiljke

UN-a

Bezopasna roba

14.3 Klasa(e) opasnosti

prijevoza

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 rasutom

stanju prema aneksu II

konvencije MARPOL 73/78 i

IBC kodu

Bezopasna roba

ODJELJAK 15. INFORMACIJE O PROPISIMA

15.1 Propisi u području sigurnosti, zdravlja i okoliša/posebni propisi za tvar ili smjesu

sukladno Uredbi o

deterdžentima EZ 648/2004

30% i više: Anionski tenzidi

Nacionalni propisi

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

Druge uredbe

Zakon o kemikalijama, Pravilnik o razvrstavanju, označavanju,

obilježavanju i pakiranju opasnih kemikalija-rađen prema CLP-u,

Zakon o biocidnim pripravcima , 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

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br. 1907/2006

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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 sigurnosti kemikalija

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

ODJELJAK 16. OSTALE INFORMACIJE

Cjelovit tekst R-fraza

Štetno ako se proguta

Nadražuje oči

Nadražuje kožu.

Opasnost od teških ozljeda očiju

R51/53

Otrovno za organizme koji žive u vodi, može dugotrajno štetno djelovati

u vodi

R52/53

Štetno za organizme koji žive u vodi, može dugotrajno štetno djelovati u

vodi

Štetno: može izazvati oštećenja pluća ako se proguta

Cjelovit tekst H-izjava

H290

Može nagrizati metale.

H302

Štetno ako se proguta.

H304

Može biti smrtonosno ako se proguta i uđe u dišni sustav.

H315

Nadražuje kožu.

H318

Uzrokuje teške ozljede oka.

H319

Uzrokuje jako nadraživanje oka.

H410

Vrlo otrovno za vodeni okoliš, s dugotrajnim učincima.

H412

Štetno za vodeni okoliš s dugotrajnim učincima.

Cjelovit tekst ostalih skraćenica

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.

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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

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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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

23-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

22-8-2018

Germany Niubian tablets

Germany Niubian tablets

Germany Niubian tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

15-8-2018

G Female Oral Tablets

G Female Oral Tablets

G Female Oral Tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

10-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

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

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

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

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

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

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

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

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

16-7-2018

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Active substance: Fluoxetine) - Centralised - Renewal - Commission Decision (2018)4770 of Mon, 16 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/R-18

Europe -DG Health and Food Safety