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  • Trgovački naziv:
  • ECO 2001 DISINCROSTANTE (904210)
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  • Medicinski uređaj

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    Zatražite informativni letak za javnost.

Lokalizacija

  • Na raspolaganju u:
  • ECO 2001 DISINCROSTANTE (904210)
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 115235E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

ECO 2001 DISINCROSTANTE

SIGURNOSNO- TEHNIČKI LIST

Ime proizvoda

ECO 2001 DISINCROSTANTE

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

:

1.1 Identifikator proizvoda

1.3 Detalji dobavljača sigurnosno tehničkog lista

1.2 Važne identificirane uporabe tvari ili smjese i uporabe protiv kojih se savjetuje

Identificirane uporabe

ODJELJAK 1: Identifikacija supstance/smjese i kompanije/poduzeća

Kod proizvoda

:

Ne preporučive uporabe

1.4 Telefon zа hitne slučajeve

Nacionalno savjetodavno tijelo/Centar za trovanja

Sredstvo za čišćenje u prehrambenoj industriji. CIP proces.

Nisu poznati.

Ecolab d.o.o.

Zavrtnica 17

10 000 Zagreb

tel: +385 1 6321 600

fax: +385 1 6321 633

email:iva.nola@ecolab.com

:

Proizvođač/ Distributer/

Uvoznik

:

Broj telefona

Hrvatska: 1 476 6464, 06-80-201-199

Bosna i Hercegovina: 112

115235E

Uporaba proizvoda

:

Sredstvo za čišćenje

Samo za profesionalnu uporabu

Proizvođač/ Distributer/ Uvoznik

:

Broj telefona

112 (medicinske informacije na broj +385 (0)1 2348 342)

Izdanje

: 1

Klasifikacija

C; R35

:

:

Opasnosti za ljudsko

zdravlje

Izaziva teške opekotine.

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

Klasifikacija prema Regulativi (EC) 1272/2008 [CLP/GHS]

ODJELJAK 2: Identifikacija opasnosti

2.1 Klasifikacija supstance ili mješavine

Definicija proizvoda

:

Mješavina

Vidjeti Odjeljak 16 za cijeli tekst R fraza i H iskaza gore priopćenog.

Klasifikacija prema Uredbi 1999/45/EC [DPD]

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

2.2 Elementi označavanja

Piktogrami opasnosti

:

Signalna riječ

:

Opasnost

Skin Corr. 1A, H314

Sadrži

:

Nitric acid

Datum izdanja/Datum revizije

:

1/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 2: Identifikacija opasnosti

:

Druge opasnosti koje ne

rezultiraju u klasifikaciji

Izjava opasnosti

:

Prevencija

:

Izjava opreza

Odgovor

:

P280 - Nositi zaštitne rukavice i zaštitu za oči/lice.

P303 + P361 + P353 - U SLUČAJU DODIRA S KOŽOM (ili kosom): Odmah skinuti

svu zagađenu odjeću. Isprati kožu s vodom ili tušem.

P305 + P351 + P338 - U SLUČAJU DODIRA S OČIMA: Ispirati oprezno vodom

nekoliko minuta. Odstraniti kontaktne leće, ako je moguće. Nastaviti ispirati.

P310 - Odmah nazvati CENTAR ZA KONTROLU OTROVANJA ili liječnika.

2.3 Druge opasnosti

Nije primjenljiv.

H314

Uzrokuje teške opekline kože i ozljede oka.

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

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

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

ODJELJAK 3: Sastav/informacije o sastojcima

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

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

[3] Tvar ispunjava kriterije za OBT prema Propisu (EC) Br 1907/2006, Aneks XIII

[4] Tvar ispunjava kriterije za vPvB prema Propisu (EC) Br 1907/2006, Aneks XIII

Indentifikatori

67/548/EEC

Naziv

proizvoda/sastojka

%

Tip

Pravilo (EC) Br.

1272/2008 [CLP]

Klasifikacija

Vidjeti odjeljak 16 za

cijeli tekst R-fraza

gore deklariranih

Vidjeti Odjeljak 16 za

cijeli tekst H iskaza

gore priopćenog.

Nitric acid

REACH #: 01-

2119487297-23

EC: 231-714-2

CAS (Služba kemijskih

abstrakata): 7697-37-2

Indeks: 007-004-00-1

20-70

O; R8

C; R35

Ox. Liq. 3, H272

Skin Corr. 1A, H314

[1] [2]

fosforna kiselina

REACH #: 01-

2119485924-24

EC: 231-633-2

CAS (Služba kemijskih

abstrakata): 7664-38-2

Indeks: 015-011-00-6

<10

C; R34

Skin Corr. 1B, H314

[1] [2]

Mješavine

3.2

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Odmah isprati oči s velikom količinom vode, te povremeno podići gornje i donje

kapke. Provjeriti postojanje leća te iste ukloniti. Nastaviti ispirati najmanje 10

minuta. Lliječnik mora smjesta tretirati kemijske opekline.

4.1 Opis mjera prve pomoći

Kontakt očima

:

ODJELJAK 4: Mjere prve pomoći

Datum izdanja/Datum revizije

:

2/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 4: Mjere prve pomoći

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Isprati usta vodom. Ukloniti umjetno zubalo ako postoji. Ukoliko je tvar progutana i

izložena osoba je pri svijesti, dati popiti male količine vode. Prestati ukoliko izložena

osoba osjeća mučninu jer povraćanje može biti opasno. Ne izazivati povraćanje

osim ako to nije naloženo od strane medicinskog osoblja. Ukoliko dođe do

povraćanja, glavu treba držati spuštenom tako da izbljuvak ne uđe u pluća. Lliječnik

mora smjesta tretirati kemijske opekline. Osobi bez svijesti nikad ništa ne davati na

usta. Ukoliko je osoba bez svijesti, postaviti je u bočni položaj i smjesta osigurati

liječničku pomoć. Održavati slobodan protok zraka. Popustiti usku odjeću poput

okovratnika, kravate, pojasa ili remena. Premjestiti unesrećenog na svježi zrak,

umiriti ga i postaviti u položaj koji olakšava disanje.

Kontakt s kožom

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Oprati kontaminiranu kožu sapunom i vodom. Skinuti kontaminiranu odjeću i cipele.

Oprati kontaminiranu odjeću prije ponovne upotrebe. Nastaviti ispirati najmanje 10

minuta. Lliječnik mora smjesta tretirati kemijske opekline. Temeljito očistiti cipele

prije ponovne upotrebe.

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

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

disanje. Ukoliko se sumnja da su zagušljiva isparenja i dalje prisutna, spasilac treba

nositi odgovarajuću masku ili samostalni dišni aparat. Ukoliko nema disanja, ukoliko

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

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

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

osigurati liječničku pomoć. Održavati slobodan protok zraka. Popustiti usku odjeću

poput okovratnika, kravate, pojasa ili remena. U slučaju udisanja proizvoda

dekompozicije u požaru, simptomi mogu biti odloženi.

Gutanje

Udisanje

:

:

:

Zaštita pružalaca prve

pomoći

:

4.2 Najvažniji simptomi i efekti, i akutni i odloženi

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Može ispuštati plinove ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Izlaganje produktima raspadanja može prouzročiti opasnosti za zdravlje. Ozbiljni

efekti mogu biti odloženi nakon izlaganja.

Može izazvati opekline usta, grla i trbuha.

:

Gutanje

Kontakt s kožom

:

Izaziva teške opekotine.

Uzrokuje teške ozljede oka.

:

Kontakt očima

Znaci/simptomi pretjeranog izlaganja

Kontakt s kožom

Udisanje

Štetni simptomi mogu uključivati slijedeće:

nadražaj dišnog sustava

kašljanje

Štetni simptomi mogu uključivati slijedeće:

bol ili nadraživanje

crvenilo

može se dogoditi stvaranje mjehura

:

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

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

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

i dalje prisutna, spasilac treba nositi odgovarajuću masku ili samostalni dišni aparat.

Oživljavanje usta na usta može biti opasno po pružaoca pomoći. Temeljito vodom

oprati kontaminiranu odjeću prije skidanja, ili nositi rukavice.

Datum izdanja/Datum revizije

:

3/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 4: Mjere prve pomoći

Obavijesti liječniku

U slučaju udisanja proizvoda dekompozicije u požaru, simptomi mogu biti odloženi.

:

Dodatna upozorenja

Gutanje

Štetni simptomi mogu uključivati slijedeće:

bolovi u trbuhu

:

4.3 Indikacija potrebe za liječničkom pomoći bez odgode i specijalnim liječenjem

Nema specifičnog liječenja.

:

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

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

aktivnost za koju osoba nije prošla odgovarajuću obuku.

Opasni samozapaljivi

proizvodi

Opasnosti od tvari ili

smjese

Produkti raspadanja mogu uključivati sljedeće materijale:

oksidi dušika

oksidi fosfora

U požaru ili ako grijano, dogodit će se porast tlaka i kontejner može prsnuti.

Vatrogasci bi trebali nositi odgovarajuću zaštitnu opremu i samostalni aparat za

disanje koji pokriva čitavo lice i koji je pod pozitivnim tlakom.

Posebna oprema za zaštitu

vatrogasaca

5.1 Sredstva za gašenje požara

:

:

:

Nisu poznati.

Odgovarajuća sredstva za

gašenje

:

Neodgovarajuća sredstva

za gašenje

:

ODJELJAK 5: Vatrogasne mjere

5.2 Specijalne opasnosti koje proističu od tvari ili smjese

5.3 Savjet za vatrogasce

Specijalna mjere

predostrožnosti za

vatrogasce

:

6.2 Mjere zaštite okoliša

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

odvodima i kanalizacijom. Obavijestiti odgovarajuće vlasti ukoliko je proizvod

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

Zaustaviti propuštanje ako ne postoji rizik. Ukloniti spremnike s mjesta izlijevanja.

Razrijediti vodom i prebrisati ako je topivo u vodi. Alternativno, ili ako nije topivo u

vodi, absorbirati sa inertnim suhim materijalom i odložiti u odgovarajući kontejner za

odlaganje otpada.

Malo izljevanje

:

6.3 Metode i materijali za zadržavanje i čišćenje

ODJELJAK 6: Mjere za slučajna ispuštanja

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

Za ne-interventno osoblje

:

Za pružaoce hitne pomoći

:

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

osoba nije prošla odgovarajuću obuku. Spriječiti ulazak nepotrebnog i nezaštićenog

osoblja. Izbjegavati diranje i hodanje po prolivenom materijalu. Ne udisati pare ili

maglu. Osigurati odgovarajuću ventilaciju. Nosite prikladni respirator kad je

ventilacija neadekvatna. Staviti prikladnu osobnu zaštitnu opremu.

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

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

Pogledati također informacije u "Za ne-interventno osoblje".

:

Datum izdanja/Datum revizije

:

4/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 6: Mjere za slučajna ispuštanja

Zaustaviti propuštanje ako ne postoji rizik. Ukloniti spremnike s mjesta izlijevanja.

Prići izlivenom sadržaju iz smjera puhanja vjetra. Spriječiti prilaz kanalizaciji,

vodotocima, podrumima ili zatvorenim prostorima. Isprati izljevanja u postrojenje za

prečišćavanje otpadnih voda ili postupiti po slijedećem. Zadržati i pokupiti izljev

negorivim, apsorbirajućim materijalom na pr. pijeskom, zemljom, vermikulitom,

diatomejskom zemljom i smjestiti u kontejner za odlaganje u skladu s lokalnim

pravilima. Proliveni material može biti neutraliziran natrij karbonatom, natrij

bikarbonatom ili natrij hidroksidom. Kontaminirani apsorbirajući materijal može

predstavljati istu opasnost poput prolivenog proizvoda.

Veliko izljevanje

:

6.4 Upućivanje na druge

odjeljke

Vidjeti Odjeljak 1 za hitne konakt informacije.

Vidjeti Odjeljak 8 za informacije o prikladnoj osobnoj zaštitnoj opremi.

Vidjeti Odjeljak 13 za dodatne informacije o obradi otpada.

:

Skladištiti na temperaturi između: -20 do 40°C (-4 do 104°F). Skladištiti u skladu sa

lokalnim uredbama. Skladištiti u originalnom spremniku zaštićeno od izravnog

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

nekompatiblinih materijala (vidjeti odjeljak 10), te hrane i pića. Odijeliti od lužina.

Držati spremnik čvrsto zatvoren i zapečaćen dok nije spreman za uporabu. Posude

koje su otvorene moraju biti pažljivo nanovo zabrtvljene i držane uspravno radi

spriječavanja odljevanja. Ne skladištiti u neobilježenim kontejnerima. Koristiti

odgovarajuću ambalažu kako bi se spriječilo zagađivanje okoliša.

ODJELJAK 7: Rukovanje i skladištenje

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Lista identificiranih uporaba u Odjeljku 1 treba biti

konzultirana za bilo koju dostupnu uporabno specifičnu informaciju datu u Scenariju(ima) izloženosti.

7.1 Mjere predostrožnosti za sigurno rukovanje

Sigurnosne mjere

:

Savjet o općoj

profesionalnoj higijeni

:

7.2 Uvjeti za sigurno

skladištenje, uključujući bilo

koje nekompatibilnosti

7.3 Specifični krajnji korisnik(ci)

Staviti odgovarajuću osobnu zaštitnu opremu (vidjeti odjeljak 8). Ne smije dospjeti u

oči ili na kožu ili odjeću. Ne udisati pare ili maglu. Ne gutati. Ukoliko tijekom

normalne uporabe materijal prestavlja opasnost po disanje, koristiti samo uz

odgovarajuću ventilaciju ili nositi odgovarajući respirator. Čuvati u u originalnom

kontejneru ili odobrenom alternativnom napravljenom od kompatibilnog materijala,

držanog čvrsto zatvorenim kad nije u upotrebi. Držati se podalje od lužina. Prazni

spremnici sadrže ostatke proizvoda i mogu biti opasni.

Radnici trebaju oprati ruke i lice prije jedenja, pijenja i pušenja. Vidjeti također

Odjeljak 8 za dodatne informacije o higijenskim mjerama.

:

Preporuke

:

Specifične otopine za

industrijski sektor

:

Nije primjenljiv.

Nije primjenljiv.

ODJELJAK 8: Kontrole izlaganja/osobna zaštita

8.1 Kontrolni parametri

Limit profesionalnog izlaganja

Datum izdanja/Datum revizije

:

5/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 8: Kontrole izlaganja/osobna zaštita

Zaštita ruku

(EN 374)

Upotrijebiti ispravno postavljen, respirator koji pročišćava zrak ili koji koristi već

očišćeni zrak, koji je u skladu sa odobrenim standardom, ukoliko analiza rizika

ukazuje na neophodnost. Odabir respiratora se mora zasnivati na poznatim ili

očekivanim nivoima izloženosti, štetnostima tvari i granicama sigurnog djelovanja

odabranog respiratora. Ukoliko su radnici izloženi koncentracijama iznad

dozvoljenih granica izlaganja, moraju koristiti odgovarajuće, certificirane respiratore.

(P2)

Preporuča se : Rukavice - butil-guma , nitril-guma ( Vrijeme prodiranja: 1 - 4 sati ) .

Preporuča se : Sigurnosne naočale. Naočale, Zaštita za lice ili ostala sredstva za

potpunu zaštitu lica.

Zaštita оčiju/lica

(EN 166)

Zaštita dišnih puteva

(EN 143, 14387)

:

:

:

Zaštita kože

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

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

proizvoda.

:

Kontrole izlaganja zaštite

okoliša

:

Emisije iz ventilacije ili opreme radnog procesa trebaju biti prekontrolirane radi

osiguranja da udovoljavaju zahtjevima zakonskih propisa o ekološkoj zaštiti. U

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

će neophodne za redukciju emisija na prihvatljive nivoe.

Odgovarajuće inženjerske

kontrole

:

Ukoliko se pri rukovanju stvara prašina, plinovi, para ili magla, upotrebiti procesne

zatvorene prostore, lokalnu ventilaciju ispušnih plinova ili druge mehaničke

upravljačke uređaje radi očuvanja izlaganja radnika kontaminantima u zraku ispod

preporučenih ili zakonskih limita.

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

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

tehnike trebaju biti korištene pri uklanjanju potencijalno kontaminirane odjeće.

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

ispiranje očiju i tuševi blizu radnih mjesta.

8.2 Tehničke mjere za smanjenje izloženosti

Higijenske mjere

:

Nema dostupnih Izvedene razine učinka.

Predviđen učinak koncentracija

Nema dostupnih Predviđen učinak koncentracija.

Izvedene razine učinka

Individualne mjere zaštite

Zaštita tijela

(EN 14605)

:

Druga zaštita kože

Termičke opasnosti

:

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

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

strane stručnjaka prije rukovanja s ovim proizvodom.

Nije primjenljiv.

Naziv proizvoda/sastojka

Granične vrijednosti izlaganja

Nitric acid

TRGS900 AGW (Njemačka, 8/2010).

STEL: 1 ppm 15 minuta.

STEL: 2.6 mg/m³ 15 minuta.

fosforna kiselina

TRGS900 AGW (Njemačka, 8/2010).

TWA: 2 mg/m³ 8 sat(i). Oblik: inhalable fraction

PEAK: 4 mg/m³ 15 minuta. Oblik: inhalable fraction

Datum izdanja/Datum revizije

:

6/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 9: Fizikalna i kemijska svojstva

Fizikalno stanje

Točka taljenja/točka

smrzavanja

Inicijalna točka vrelišta i opseg

vrenja

Tlak pare

Relativna gustoča

Gustoća pare

Topljivost(i)

Tekućina.

1.23 do 1.25

Lako topivo u slijedećim materijalima: hladnoj vodi i topla vodi.

Bez mirisa.

Miris

pH

Bistro.

Boja

Brzina isparavanja

Temperatura samozapaljena

Temperatura zapaljenja

> 100°C

0 do 1 [Konc. (% t/t): 100%]

Prag mirisa:

Oktanol/voda koeficijent

raspodjele

Svojstva eksploziva

:

:

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Oksidirajuća svojstva

:

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Izgled

9.2 Ostale informacije

Vrijeme izgaranja

Brzina izgaranja

:

:

Temperatura dekompozicije

:

Nema dodatnih informacija.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Nije primjenljiv.

Ne može se primijeniti i /ili odrediti iz mješavine.

Viskozitet

:

Gornje/donje granice

zapaljivosti ili eksplozivnosti

:

Ne može se primijeniti i /ili odrediti iz mješavine.

Zapaljivost (krutina, plin)

:

Ne može se primijeniti i /ili odrediti iz mješavine.

10.4 Uvjeti koje treba

izbjegavati

Nema specifičnih podataka.

Proizvod je stabilan.

10.2 Kemijska stabilnost

:

:

10.5 Nekompatibilni

materijali

:

10.3 Mogućnost opasnih

reakcija

:

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

ODJELJAK 10: Stabilnost i reaktivnost

10.1 Reaktivnost

:

Na raspolaganju nema specifičnih test podataka vezanih za reaktivnost za ovaj

proizvod ili njegove sastojke.

Ekstremno reaktivan ili nekompatibilan sa sljedećim materijalima: organski materijali,

metali i lužine.

Datum izdanja/Datum revizije

:

7/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 10: Stabilnost i reaktivnost

10.6 Opasni proizvodi

raspadanja

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

smjeli biti proizvedeni.

:

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Može ispuštati plinove ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Izlaganje produktima raspadanja može prouzročiti opasnosti za zdravlje. Ozbiljni

efekti mogu biti odloženi nakon izlaganja.

Može izazvati opekline usta, grla i trbuha.

:

Gutanje

Kontakt s kožom

:

Izaziva teške opekotine.

Uzrokuje teške ozljede oka.

:

Kontakt očima

akutno trovanje

Nitric acid

LDLo Oralno

Ljudski

430 mg/kg

fosforna kiselina

LD50 Oralno

Štakor

1.25 g/kg

Naziv proizvoda/sastojka

Rezultat

Vrste

Doza

Izlaganje

Karcinogenost

Mutagenost

Teratogenost

Reproduktivna toksičnost

Simptomi u svezi s fizičkim, kemijskim i toksikološkim karakteristikama

Gutanje

Udisanje

Nema specifičnih podataka.

Štetni simptomi mogu uključivati slijedeće:

bolovi u trbuhu

:

:

Iritacija/korozija

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Sensitajzer

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

ODJELJAK 11: Toksikološke informacije

11.1 Informacije o toksikološkim učincima

Akutne procjene toksičnosti

Nema podataka za proizvod.

Toksičnost specifično određenih organa (samo jedno izlaganje)

Toksičnost specifično određenih organa (ponovljeno izlaganje)

Opasnost od aspiracije

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Informacije o vjerojatnim

putevima izlaganja

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Datum izdanja/Datum revizije

:

8/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 11: Toksikološke informacije

Potencijalne kronične zdravstvene posljedice

Značajne posljedice ili kritične opasnosti nisu poznate.

Opća

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Karcinogenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Mutagenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Teratogenost

:

Razvojni efekti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Efekti fertilnosti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Kontakt s kožom

Štetni simptomi mogu uključivati slijedeće:

bol ili nadraživanje

crvenilo

može se dogoditi stvaranje mjehura

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

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

Kratkotrajno izlaganje

Dugotrajno izlaganje

Potencijalni neposredni

učinci

:

Potencijalni odgođeni

učinci

:

Potencijalni neposredni

učinci

:

Potencijalni odgođeni

učinci

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Ostale informacije

:

Značajne posljedice ili kritične opasnosti nisu poznate.

ODJELJAK 12: Ekološke informacije

LogP

ow

BCF

Moguć

12.3 Bioakumulativni potencijal

Naziv proizvoda/sastojka

Nitric acid

-0.21

nizak

12.1 Otrovnost

12.2 Postojanost i razgradivost

Zaključak/Sažetak

:

Većinski anorganski proizvod. Podaci o biorazgradljivosti se odnose samo na

organske sastojke.

PBT

:

Nije primjenljiv.

12.4 Pokretljivost kroz tlo

12.5 Rezultati OBT i vPvB procjene

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Tlo/voda koeficijent

raspodjele (K

OC

)

:

Nema podataka za proizvod.

Pokretljivost

:

Nema podataka za proizvod.

Datum izdanja/Datum revizije

:

9/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 12: Ekološke informacije

12.6 Drugi štetni efekti

Značajne posljedice ili kritične opasnosti nisu poznate.

vPvB

:

Nije primjenljiv.

:

Katalog Europskog otpada (EWC)

Opasni otpad

:

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

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

moraju biti odloženi na siguran način. Značajne količine otpadnog ostatka proizvoda

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

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

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

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

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

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

vodotocima, odvodima i kanalizacijom.

:

Metode odlaganja

ODJELJAK 13: Okolnosti odlaganja

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Lista identificiranih uporaba u Odjeljku 1 treba biti

konzultirana za bilo koju dostupnu uporabno specifičnu informaciju datu u Scenariju(ima) izloženosti.

13.1 Metode prerade otpada

Proizvod

Pakiranje

Kod otpada

Oznaka otpada

Metode odlaganja

:

Specijalne mjere

predostrožnosti

:

20 01 29*

deterdženti koji sadrže opasne tvari

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

otpad treba biti recikliran.

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

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

obloge mogu zadržati nešto ostatka proizvoda. Izbjegavati rasipanje prosutog

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

NITRIC ACID otopina

NITRIC ACID otopina

Nitric acid otopina

UN2031

NITRIC ACID otopina

UN2031

UN2031

UN2031

ODJELJAK 14: Informacije o transportu

ADR/RID

IMDG

IATA

14.1 UN broj

14.2 UN ispravni

otpremni naziv

14.3 Klasa(e)

opasnosti pri

transportu

14.4 Ambalažna

skupina

ADN/ADNR

14.5 Opasnosti za

okoliš

Datum izdanja/Datum revizije

:

10/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 14: Informacije o transportu

14.6 Specijalna

mjere

predostrožnosti za

korisnika

14.7 Transport u

nezapakiranom stanju

prema Aneks II MARPOL

73/78 i IBC Kodu

:

Nije primjenljiv.

Niti jedan.

Niti jedan.

None.

None.

Nacionalna pravila

Ostala EU pravila

Nije primjenljiv.

Aneks XVII – Restrikcija

na proizvodnju, stavljanje

na tržište i uporabu

određenih opasnih tvari,

smjesa i artikala

:

Hrvatska

ODJELJAK 15: Regulatorne informacije

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

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

Aneks XIV – Lista tvari podvrgnutih odobrenju

15.2 Procjena sigurnosti

kemikalije

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

neophodne.

Supstance vrlo visoke zabrinutosti

:

Ni jedna komponenta nije izlistana.

***Does not contain ingredients according to the detergent regulation 648/2004/EC.***

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

Važeći lokalni propisi: Zakon o otpadu, Pravilnik o vrstama otpada , Pravilnik o postupanju s ambalažnim otpadom ,

Uredba za postupanje s opasnim otpadom.

Važeći lokalni propisi: Zakon o kemikalijama, Pravilnik o označavanju i obilježavanju otrova koji se stavljaju u promet,

Pravilnik o mjerilima za razvrstavanje otrova u skupine, Pravilnik o maksimalno dopustivim koncentracijama štetnih

tvari u atmosferi radnih prostorija i prostor MDK i o biološkim graničnim vrijednostima BGV.

Dodatni propisi: Zakon o prijevozu opasnih tvari (NN 97/93, 34/95 i 151/03)

Provedeno ocjenjivanje kemijske sigurnosti: NE

Naznačuje informacije koje su se promijenile od prethodne izdane verzije.

ODJELJAK 16: Ostale informacije

Kratice i akronimi

:

ADN/ADNR = European Provisions concerning the International Carriage of

Dangerous Goods by Inland Waterway

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

ATE- Procijenjene vrijednosti akutne toksičnosti.

BKF = Biokoncentracijski faktor

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

(regulativa (EU) br. 1272/2008

DNEL - Izvedena razina izloženosti bez učinka

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

EC = Europska Komisija

EUH izjava - CLP Ddopunske oznake upozorenja

Datum izdanja/Datum revizije

:

11/12

23 travnja 2012

HZT, klasa

:

Nema.

ECO 2001 DISINCROSTANTE

ODJELJAK 16: Ostale informacije

23 travnja 2012

Datum tiskanja

Datum izdanja/ Datum

revizije

Izdanje

Informacije navedene u ovom dokumentu smatraju se vjerodostojnima s obzirom na formulu korištenu u

proizvodnji sredstva u zemlji porijekla. Kako su promjene podataka, standarda, normi i propisa, kao i uvjeti

korištenja i rukovanja izvan naše kontrole, NE DAJE SE NIKAKVO JAMSTVO, NI IZRIČITO NITI IMPLICITNO, ZA

POTPUNOST ILI TRAJNU VALJANOST TIH INFORMACIJA."

Napomena

Datum prethodnog izdanja

:

:

:

:

23 travnja 2012

Nema prethodnih validacija

IATA = Internacionalno udruženje zračnog transporta

IBC = Kontejner srednjeg obujma

IMDG = Internacionalne pomorski opasne tvari

LogPow = logaritam koeficijenta razdjeljenja između oktanola i vode

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

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

OEL = Profesionalna granica izloženosti

PBT = Postojan, bioakumulativni i toksični

PNEC - Predviđena koncentracija bez učinka

REACH = Registracija, Evaluacija, Autorizacija i Restrikcija Kemijskih Regulativa

[Uredba (EZ) Br. 1907/2006]

RID = Uredba u vezi internacionalnog prijevoza opasnih tvari željezničkim putem

REACH #- Broj REACH registracije

vPvB = Vrlo otporno i vrlo bioakumulativno

Procedura koja se koristi za dobivanje klasifikacije prema Propisu (EC) Br 1272/2008 [CLP/GHS]

Klasifikacija

Obrazloženje

Skin Corr. 1A, H314

Na temelju test podataka

Cijeli tekst skraćenih R fraza

:

R 8 U dodiru sa zapaljivim materijalom može uzrokovati požar

R 34 Izaziva opekotine

R 35 Izaziva teške opekotine

:

Cijeli tekst klasifikacija

[DSD/DPD]

Cijeli tekst skraćenih H

iskaza

:

Cijeli tekst klasifikacija

[CLP/GHS]

:

H272

Može pojačati požar; oksidans.

H314

Uzrokuje teške opekline kože i ozljede oka.

Ox. Liq. 3, H272

OKSIDIRAJUĆE TEKUĆINE - Kategorija 3

Skin Corr. 1A, H314

nagrizanje kože/nadražaj - Kategorija 1A

Skin Corr. 1B, H314

nagrizanje kože/nadražaj - Kategorija 1B

O - Oksidirajuće

C - Nagrizajuće

Datum izdanja/Datum revizije

:

12/12

23 travnja 2012

HZT, klasa

:

Nema.

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

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

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

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

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

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

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

1-12-2011

Danish Pharmacovigilance Update, 17 November 2011

Danish Pharmacovigilance Update, 17 November 2011

In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.

Danish Medicines Agency

4-11-2011

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

5-7-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).

Danish Medicines Agency

27-5-2011

Consultation on the Reimbursement Committee's recommendation for glucosamine

Consultation on the Reimbursement Committee's recommendation for glucosamine

The Reimbursement Committee has reassessed the reimbursement status of glucosamine-containing medicines. Glucosamine-containing medicines are used for the alleviation of painful osteoarthritis. The Reimbursement Committee recommends removing general conditional reimbursement for these medicines.

Danish Medicines Agency

6-5-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B.

Danish Medicines Agency

3-6-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors) was open for consultation until 7 May 2010.

Danish Medicines Agency

9-4-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.

Danish Medicines Agency

31-3-2010

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

17-12-2009

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).

Danish Medicines Agency

2-10-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C05 (Vasoprotectives).

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C04 (Peripheral vasodilators)

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

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

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

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

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

29-5-2018

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