natgillin/translations-raw huggingface dataset:
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ml 
MIRCERA 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 30 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 100 mikrograma/ml.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 120 mikrograma metoksi polietilenglikol-epoetina beta.
Skin and subcutaneous disorders 
Poremećaji kože i potkožnog tkiva rijetko makulo-papularni osip nepoznato
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/009
Patients currently treated with an ESA: 
Bolesnici koji se trenutno ne liječe lijekovima za stimulaciju eritropoeze (LSE):
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 200 mikrograma
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 40 mikrograma napunjena štrcaljka
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 60 mikrograma
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 100 mikrograma
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 75 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mcg/0,3 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 40 mikrograma
Cases of thrombocytopenia have been reported from post-marketing setting. 
Nakon stavljanja lijeka u promet prijavljivani su slučajevi trombocitopenije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 120 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
INFORMATION IN BRAILLE mircera 50 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 50 mcg
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 200 mikrograma metoksi polietilenglikol-epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/023
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/022
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 30 mcg/0,3 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 50 mikrograma
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 30 mikrograma metoksi polietilenglikol-epoetina beta.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 50 mcg/0,3 ml
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 250 mikrograma metoksi polietilenglikol-epoetina beta.
NAME OF THE MEDICINAL PRODUCT MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mcg/0,3 ml
NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/018
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/012
NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mcg/0,3 ml
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/024
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/013
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 60 mikrograma metoksi polietilenglikol-epoetina beta.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 150 mikrograma metoksi polietilenglikol-epoetina beta.
· Never re-use a syringe. 
• Nikada nemojte istu iglu upotrijebiti dva puta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 250 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/017
NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/021
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 200 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 40 mikrograma metoksi polietilenglikol-epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/020
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/010
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/011
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 100 mikrograma metoksi polietilenglikol-epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 150 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/019
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 100 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 40 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
Peel back the protective film from the plastic tray and remove the needle and the syringe, holding the syringe by the middle of the body without touching the release clips. 
Odlijepite zaštitnu foliju s plastične plitice te izvadite iglu i štrcaljku.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 50 mikrograma metoksi polietilenglikol-epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 60 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month. 
Ukoliko je mjesečni porast hemoglobina manji od 1,0 g/dl (0,621 mmol/l) doza se smije povećati za otprilike 25% prethodne doze.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 30 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 50 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
thrombocytopenia thrombosis 
• tromboza (začepljenje krvne žile krvnim ugruškom)
Step5. 
PRILOG I.
1/1,000 to < 1/100), not known (cannot be estimated from available data). 
< 1/100), te nepoznato (ne može se procijeniti iz dostupnih podataka).
RT-PCR for PML/ RARα 
RT-PCR za PML/ RARα
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego što primite ovaj lijek jer sadrži Vama važne podatke.
Lutomierska 50, 95-200 Pabianice, Poland 
Lutomierska 50, 95-200 Pabianice, Poljska
Conventional Cytogenetics [t(15;17)] 
standardna citogenetika [t(15;17)]
The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established. 
Sigurnost i djelotvornost arsenovog trioksida u djece u dobi do 17 godina nisu ustanovljene.
*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 
*U ispitivanju CALGB C9710, 2 slučaja stupnja ≥ 3 povećane GGT prijavljena su između 200
From a microbiological point of view, the product must be used immediately. 
S mikrobiološkog stajališta, lijek se mora primijeniti odmah.
You may experience convulsions, muscle weakness and confusion. 
Možete osjetiti konvulzije, slabost u mišićima i smetenost.
If you are not sure, show the bottle or pack to your doctor. 
Ako niste sigurni, pokažite svom liječniku bocu lijeka ili njegovo pakiranje.
Ask your doctor or pharmacist for advice before taking any medicine. 
Obratite se liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions: 
Dok se liječite lijekom Arsenov trioksid Accord, možete osjetiti neke od sljedećih reakcija:
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27 
Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX27 Mehanizam djelovanja
Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population. 
Ozbiljne nuspojave bile su česte (1-10%) i nisu bile neočekivane za populaciju u fazi relapsa/refraktornoj na liječenje.
Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing. 
Osoblje mora biti obučeno za rukovanje i razrjeđivanje arsenovog trioksida te mora nositi odgovarajuću zaštitnu odjeću.
Arsenic trioxide Accord is normally given by a doctor or a nurse. 
Lijek Arsenov trioksid Accord obično daje liječnik ili medicinska sestra.
Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord. 
Vaš će liječnik poduzeti sljedeće mjere opreza: - Provest će se testovi kako bi se provjerila količina kalija, magnezija, kalcija i kreatinina u Vašoj krvi prije prve doze lijeka Arsenov trioksid Accord.
Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha. 
Arsenov trioksid također uzrokuje oštećenje ili degradaciju fuzijskog proteina PML/RAR alfa.
Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called “differentiation syndrome”, which might be fatal: 
Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava jer one mogu biti znakovi ozbiljnog stanja zvanog „sindrom diferencijacije” koji može biti smrtonosan:
The daily dose can be escalated back to 100% of the original dose if no prolongation occurs. 
Dnevna doza može se ponovno povisiti na 100% prvobitne doze ako ne nastupi produljenje.
APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 
Učestalosti se definiraju kao: (vrlo često ≥ 1/10), (često ≥ 1/100 i < 1/10), (manje često ≥ 1/1000 i
There are no data on the effect of arsenic trioxide on the QTc interval during the infusion. 
Nema podataka o učinku arsenovog trioksida na interval QTc tijekom infuzije.
is large (>400 L) indicating significant distribution into the tissues with negligible protein binding. 
Volumen distribucije (Vd) za AsIII je velik (> 400 l) što ukazuje na značajnu raspodjelu u tkiva sa zanemarivim vezivanjem na proteine.
It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur. 
Daje se kao drip (infuzija) u venu tijekom 1-2 sata, ali infuzija može trajati dulje ako se pojave nuspojave poput navale crvenila i omaglice.
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed. 
Trajanje infuzije može se produljiti do 4 sata ako se primijete vazomotoričke reakcije.
Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/µl) during induction, 4 of whom had values above 100,000/µl. 
Dvadeset i sedam bolesnika je imalo leukocitozu (leukociti ≥ 10 x 103/µl) tijekom indukcije, a od njih su 4 imala vrijednosti iznad 100 000/µl.
Arsenic trioxide dose, mg/kg/day (median, range) Complete remission 
Doza arsenovog trioksida, mg/kg/dan (medijan, raspon) Potpuna remisija
Each pack contains 1, 5 or 10 vials. 
Pakiranje sadrži 1, 5 ili 10 bočica.
- If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously. 
Ako ste pod rizikom od određenih tipova poremećenog srčanog ritma (primjerice, torsade de pointes ili produljenje QTc intervala), Vaše će srce biti pod stalnim nadzorom.
Medicinal products that are used to lower the white blood cell count often exacerbate the toxicities associated with leukocytosis, and no standard approach has proven effective. 
Lijekovi koji se koriste za snižavanje leukocita često pojačaju toksičnosti povezane s leukocitozom, te se nijedan standardni pristup nije pokazao učinkovitim.
Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails. 
Ukupni arsen akumulira se uglavnom u jetri, bubrezima i srcu te u manjem opsegu u plućima, kosi i noktima.
Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide. 
Ne očekuje se da će tvari koje su supstrati za ove enzime P450 stupiti u interakciju s arsenovim trioksidom.
Must be diluted before use. 
Razrijediti prije uporabe.
For patients with severe, acute arsenic overdose, dialysis should be considered. 
Za bolesnike s teškim, akutnim predoziranjem arsenom potrebno je uzeti u obzir dijalizu.
If you are pregnant or you become pregnant during the treatment with Arsenic trioxide Accord, you must ask your doctor for advice. 
Ako ste trudni ili zatrudnite tijekom liječenja lijekom Arsenov trioksid Accord, obratite se svom liječniku za savjet.
Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord. 
Liječnik će točno odrediti koliko dugo morate nastaviti liječenje lijekom Arsenov trioksid Accord.
Arsenic trioxide Accord with food and drink 
Arsenov trioksid Accord s hranom i pićem
Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes. 
Bolesnici koji primaju, ili koji su primali, lijekove za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju, poput diuretika ili amfotericina B, mogu biti pod većim rizikom od torsade de pointes.
Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction: 
Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava jer one mogu biti znakovi alergijskih reakcija:
Patients with complete remission received consolidation therapy with arsenic trioxide for 25 additional doses over a 5 weeks period. 
Bolesnici s potpunom remisijom primili su konsolidacijsku terapiju arsenovim trioksidom od 25 dodatnih doza u razdoblju od 5 tjedana.
Concentrate for solution for infusion 1 vial of 10 ml (10 mg/10 ml) 5 vials of 10 ml (10 mg/10 ml) 10 vials of 10 ml (10 mg/10 ml) 
Koncentrat za otopinu za infuziju 1 bočica s 10 ml (10 mg/10 ml) 5 bočica s 10 ml (10 mg/10 ml) 10 bočica s 10 ml (10 mg/10 ml)
PVC-free plastic bags should be used. 
Potrebno je upotrebljavati plastične vrećice za infuziju koje ne sadrže PVC.
For storage conditions after dilution or first opening of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon razrjeđivanja ili prvog otvaranja lijeka vidjeti u dijelu 6.3.
If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose. 
Ako se toksični događaj ne pojavi unutar 7 dana od ponovnog početka liječenja pri smanjenoj dozi, dnevna doza može se ponovno povećati na 100% početne doze.
Approximately 15% of the administered arsenic trioxide dose is excreted in the urine as unchanged AsIII. 
Približno 15% primijenjene doze arsenovog trioksida izlučuje se u mokraći kao nepromijenjeni AsIII.
- Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with Arsenic trioxide Accord. 
- Krvne pretrage (kalij, kalcij, magnezija i funkcija jetre) moraju se ponoviti tijekom liječenja lijekom Arsenov trioksid Accord.
In these studies, leukocytosis was not treated with chemotherapeutic medicinal products. 
U ovim ispitivanjima, leukocitoza se nije liječila kemoterapeuticima.
Patients who experience such reactions that are considered arsenic trioxide related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption. 
Bolesnici koji osjete takve reakcije koje se smatraju povezane s arsenovim trioksidom moraju nastaviti liječenje samo nakon rješavanja toksičnih događaja ili nakon oporavka na početno stanje abnormalnosti koje je uzrokovalo prekid liječenja.
Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2). 
Od 7 bolesnika mlađih od 18 godina (raspon od 5 do 16 godina) koji su liječeni arsenovim trioksidom pri preporučenoj dozi od 0,15 mg/kg/dan, 5 bolesnika postiglo je potpuni odgovor (vidjeti dio 4.2).
The majority of patients do not require permanent termination of arsenic trioxide therapy during treatment of the APL differentiation syndrome. 
Većina bolesnika ne zahtijeva trajan prekid liječenja arsenovim trioksidom tijekom liječenja sindroma diferencijacije APL-a.
Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: 
Arsenov trioksid indiciran je za indukciju remisije i konsolidaciju u odraslih bolesnika s:
Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given. 
Nakon toga se može davati dnevna doza penicilamina ≤ 1 mg po danu.
- fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest) 
- iznenadni porast tjelesne težine - zadržavanje vode - nesvjestica - palpitacije (snažni otkucaji srca koje možete osjetiti u prsima)
The effect of these medicines on your heartbeat can be made worse by Arsenic trioxide Accord. 
Učinak tih lijekova na Vaše otkucaje srca može se pogoršati uzimanjem lijeka Arsenov trioksid
You should report any new and exceptional symptoms and circumstances whenever you see your doctor. 
Nužno je da svaki put kada posjetite liječnika prijavite sve nove i izvanredne simptome i okolnosti.
EU/1/19/1398/001 (pack of 1 vial) EU/1/19/1398/002 (pack of 5 vials) EU/1/19/1398/003 (pack of 10 vials) 
EU/1/19/1398/002 (pakiranje od 5 bočica) EU/1/19/1398/003 (pakiranje od 10 bočica)
What Arsenic trioxide Accord is and what it is used for 
Što je Arsenov trioksid Accord i za što se koristi
It is recommended that chemotherapy not be added to treatment with steroids since there is no experience with administration of both steroids and chemotherapy during treatment of the leukocyte activation syndrome due to arsenic trioxide. 
Preporučuje se da se kemoterapija ne dodaje liječenju steroidima jer nema iskustva s primjenom i steroida i kemoterapije tijekom liječenja sindroma aktivacije leukocita izazvanog arsenovim trioksidom.