FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Croatian: Iz ovog su ispitivanja bili isključeni bolesnici sa značajnim aritmijama, odstupanjima u EKG-u (kongenitalnim sindromom produljenog QT intervala, anamnezom ili prisutnošću značajnih ventrikularnih ili atrijskih tahiaritmija, klinički značajnom bradikardijom u mirovanju (< 50 otkucaja srca u minuti), QTc > 450 ms na probirnom EKG-u, blokom desne grane i prednjim lijevim hemiblokom, bifascikularnim blokom) ili neuropatijom.
English: If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte primiti lijek Arsenov trioksid Accord ako ste alergični na arsenov trioksid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Time to bone marrow remission (median)
Croatian: Vrijeme do potpune remisije (medijan)
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperglikemija
English: - Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in Arsenic trioxide Accord, may cause other cancers.
Croatian: - Liječnik će možda nadzirati Vaše zdravlje tijekom i nakon liječenja, jer arsenov trioksid,
English: If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Accord.
Croatian: Ako možete zatrudnjeti, morate koristiti učinkovitu metodu kontrole začeća tijekom liječenja lijekom
English: Arsenic trioxide has been investigated in 77 newly diagnosed patients with low to intermediate risk APL, in a controlled, randomized, non-inferiority Phase 3 clinical study comparing the efficacy and safety of arsenic trioxide combined with all-trans-retinoic acid (ATRA) with those of ATRA+chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Croatian: Bolesnici s novodijagnosticiranim APL-om koji nije visokog rizika Arsenov trioksid ispitan je u 77 novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika u kontroliranom, randomiziranom, kliničkom ispitivanju neinferiornosti faze 3 koje je uspoređivalo djelotvornost i sigurnost liječenja arsenovim trioksidom u kombinaciji sa sve-trans-retinoatnom kiselinom (ATRA) u odnosu na kombinirano liječenje ATRA+kemoterapija (npr. idarubicin i mitoksantron) (Ispitivanje APL0406).
English: Any unused product, any items that come into contact with the product, and waste material must be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek, bilo koji predmet koji dolazi u dodir s lijekom i otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both (see section 4.4).
Croatian: Međutim, toksični su se učinci povukli pri privremenom prekidu liječenja bilo arsenovim trioksidom, lijekom ATRA ili obama lijekovima (vidjeti dio 4.4).
English: APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
Croatian: APL = akutna promijelocitna leukemija; ATRA = sve-trans-retinoatna kiselina APL u fazi relapsa/refraktoran na liječenje
English: Thereafter, in absence of worsening of the previous toxicity, arsenic trioxide should be resumed at full dosage.
Croatian: Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, potrebno je nastaviti liječenje arsenovim trioksidom u punoj dozi.
English: Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Croatian: Rok valjanosti nakon razrjeđivanja: Kemijska i fizikalna stabilnost u primjeni dokazane su tijekom 24 sata na temperaturi od 25°C i tijekom 48 sati na temperaturi od 2°C do 8°C.
English: Patients in the first study received a median dose of 0.16 mg/kg/day of arsenic trioxide (range 0.06
Croatian: Bolesnici u prvom ispitivanju primili su medijan doze arsenovog trioksida od 0,16 mg/kg/dan (raspon od 0,06 do 0,20 mg/kg/dan) a bolesnici u multicentričnom ispitivanju primili su fiksnu dozu od
English: Cytogenetics after arsenic trioxide therapy
Croatian: Citogenetika nakon terapije arsenovim trioksidom
English: Arsenic trioxide Accord must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Croatian: Lijek Arsenov trioksid Accord ne smije se miješati ili davati istodobno s drugim lijekovima kroz istu intravensku liniju.
English: Patients in the ATRA+chemotherapy treatment group also received maintenance treatment for up to 2 years, consisting of oral 6-mercaptopurine at 50 mg/m2 daily, intramuscular methotrexate at 15 mg/m2 weekly, and ATRA at 45 mg/m2 daily for 15 days every 3 months.
Croatian: Bolesnici u skupini liječenoj kombinacijom ATRA+kemoterapija također su primali liječenje održavanja tijekom 2 godine koje se sastojalo od peroralno primijenjenog 6-merkaptopurina u dozi od 50 mg/m2 dnevno, metotreksata u dozi od 15 mg/m2 tjedno primijenjenog intramuskularno i ATRA-e u dozi od 45 mg/m2 dnevno tijekom 15 dana svaka 3 mjeseca.
English: In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
Croatian: U jednog novodijagnosticiranog bolesnika indukcijsko je liječenje bilo prekinuto zbog jako produljenog QTc intervala i poremećaja elektrolita 3. dana indukcijskog liječenja.
English: The arsenic in Arsenic trioxide Accord passes into breast milk.
Croatian: Arsen u lijeku Arsenov trioksid Accord izlučuje se u majčino mlijeko.
English: There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleukocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Croatian: Nije se činilo da postoji veza između početnih vrijednosti leukocita i razvoja leukocitoza niti se pojavila korelacija između početnih i vršnih vrijednosti leukocita.
English: Patients in the ATRA+chemotherapy treatment group received iv idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then iv mitoxantrone at 10 mg/m2 on days 1 to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
Croatian: Tijekom konsolidacije bolesnici su primali idarubicin u dozi od 5 mg/m2 tijekom 1.- 4. dana i ATRA-u u dozi od 45 mg/m2 dnevno tijekom 15 dana, potom u venu mitoksantron u dozi od 10 mg/m2 tijekom 1.5. dana i ATRA-u ponovno u dozi od 45 mg/m2 dnevno tijekom 15 dana i konačno jednu dozu idarubicina od 12 mg/m2 i ATRA-e od 45 mg/m2 dnevno tijekom 15 dana.
English: Arsenic trioxide has been investigated in 52 APL patients, previously treated with an anthracycline and a retinoid regimen, in two open-label, single-arm, non-comparative studies.
Croatian: Arsenov trioksid ispitivan je u 52 bolesnika s APL-om, koji su prethodno bili liječeni antraciklinom i retinoidima u dva otvorena, neusporedna ispitivanja s pojedinačnim skupinama.
English: Herpes zoster
Croatian: Herpes zoster sepsa pneumonija
English: Treatment with arsenic trioxide must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Croatian: Liječenje arsenovim trioksidom mora se prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti hepatotoksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak.
English: If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, arsenic trioxide therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Croatian: U slučaju sinkope, brzih ili nepravilnih srčanih otkucaj,a bolesnika se mora hospitalizirati i neprekidno nadzirati, te odrediti razinu elektrolita u serumu, a liječenje arsenovim trioksidom privremeno prekinuti sve dok se QTc interval ne vrati na vrijednost ispod 460 ms,
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava parestezija
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA.
Croatian: Među novodijagnosticiranim bolesnicima s APL-om niskog do srednjeg rizika, njih 63,2% razvilo je hepatotoksične učinke 3. ili 4. stupnja tijekom indukcijskog ili konsolidacijskog liječenja arsenovim trioksidom u kombinaciji s ATRA-om.
English: No clinical or non-clinical fertility studies have been conducted with arsenic trioxide.
Croatian: Plodnost Nisu provedena klinička ili neklinička ispitivanja utjecaja arsenovog trioksida na plodnost.
English: Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Croatian: Arsenov trioksid mora se primjenjivati intravenski pri dozi od 0,15 mg/kg/dan, svaki dan, sve dok se ne postigne potpuna remisija.
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
Croatian: Novodijagnosticirana akutna promijelocitna leukemija (APL) niskog do srednjeg rizika
English: All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Sve parenteralne otopine treba prije primjene vizualno pregledati na prisutnost čestica i promjenu boje.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: POTREBNO JE PRIDRŽAVATI SE STROGIH ZAHTJEVA ASEPTIČKE TEHNIKE TIJEKOM
English: • some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
Croatian: • neke vrste lijekova za liječenje bakterijskih infekcija (primjerice, eritromicin i sparfloksacin) • neke lijekove za liječenje alergija poput peludne groznice, zvani antihistaminici (primjerice terfenadin i astemizol)
English: At last follow-up, 6 of 12 patients in the single institution study were alive with a median follow-up time of 28 months (range 25 to 29).
Croatian: bolesnika u monocentričnom ispitivanju s medijanom vremena kontrole od 28 mjeseci (raspon 25 do
English: Arsenic trioxide Accord is a concentrate for solution for infusion.
Croatian: - Lijek Arsenov trioksid Accord koncentrat je za otopinu za infuziju.
English: Package leaflet: Information for the user Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Croatian: Uputa o lijeku: Informacije za korisnika Arsenov trioksid Accord 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: Other medicines and Arsenic trioxide Accord
Croatian: Drugi lijekovi i Arsenov trioksid Accord
English: One vial of 10 ml contains 10 mg of arsenic trioxide.
Croatian: Jedna bočica od 10 ml sadrži 10 mg arsenovog trioksida.
English: Arsenic is excreted in human milk.
Croatian: Dojenje Arsen se izlučuje u majčino mlijeko.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV
Croatian: Procijenjena srednja vrijednost terminalnog poluvremena eliminacije metabolita MMAV i DMAV su 32 sata odnosno 70 sati.
English: - difficulty in breathing
Croatian: - poteškoće u disanju - vrućica
English: One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadrži 1 mg arsenovog trioksida.
English: One ml contains 1 mg of arsenic trioxide.
Croatian: Jedan ml sadrži 1 mg arsenovog trioksida.
English: Leukocyte activation syndrome (APL differentiation syndrome) 27 % of patients with APL, in the relapsed/refractory setting, treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis.
Croatian: Sindrom aktivacije leukocita (sindrom diferencijacije APL-a) U 27% bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje i koji su liječeni arsenovim trioksidom pojavili su se simptomi slični sindromu zvanom sindrom retinoatne kiseline u akutnoj promijelocitnoj leukemiji (RA-APL) ili sindrom diferencijacije APL-a, koji karakteriziraju vrućica,
English: In newly diagnosed and relapsed/refractory APL patients who develop sustained leukocytosis after initiation of therapy, hydroxyurea should be administered.
Croatian: a koji su razvili trajnu leukocitozu nakon započinjanja terapije potrebno je primijeniti hidroksiureju.
English: Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to Arsenic trioxide treatment.
Croatian: Liječenje arsenovim trioksidom mora se privremeno prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti toksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak te procijeni da su toksični učinci možda povezani s liječenjem arsenovim trioksidom.
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Croatian: Arsenov trioksid Accord 1 mg/ml koncentrat za otopinu za infuziju
English: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with Arsenic trioxide, caution is advised in the use of Arsenic trioxide in patients with hepatic impairment (see section 4.4 and 4.8).
Croatian: S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja arsenovim trioksidom, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem jetre (vidjeti dio 4.4 i 4.8).
English: In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25).
Croatian: U monocentričnom ispitivanju preživjelo je 27 od 40 bolesnika s medijanom vremena kontrole od
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Croatian: Tijekom liječenja arsenovim trioksidom mogu se pojaviti hepatotoksični učinci; potreban je oprez kada se arsenov trioksid primjenjuje istodobno s drugim lijekovima za koje je poznato da imaju hepatotoksične učinke (vidjeti dijelove 4.4 i 4.8).
English: hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Croatian: Pentavalentni metaboliti MMAV i DMAV, sporo se pojavljuju u plazmi (približno 10-24 sata nakon prve primjene arsenovog trioksida), ali zbog njihova duljeg poluvremena, akumuliraju se više nakon višestrukog doziranja nego AsIII.
English: Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.
Croatian: Leukocitoza se pojavila u 50% bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje,
English: Not known (frequency cannot be estimated from the available data): - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion
Croatian: - crvenilo kože, natečeno lice, zamućeni vid Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - infekcija pluća, infekcija u krvi - upala pluća koja uzrokuje bol u prsima i nedostatak zraka, zatajenje srca
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during arsenic trioxide clinical trials in 52 patients with refractory/relapsed
Croatian: preporučenim izrazima, prema klasi organskih sustava i učestalosti primijećenoj tijekom liječenja arsenovim trioksidom u kliničkim ispitivanjima na 52 bolesnika s APL-om u refraktornoj fazi/relapsu.
English: Since no data are available across all renal impairment groups, caution is advised in the use of Arsenic trioxide in patients with renal impairment.
Croatian: S obzirom da ni za jednu skupinu s oštećenjem bubrega nema dostupnih podataka, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem bubrega.
English: The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen.
Croatian: Djelatna tvar lijeka Arsenov trioksid Accord, arsenov trioksid, kancerogen je za ljude.
English: There are no studies in pregnant women using arsenic trioxide.
Croatian: Ispitivanja na trudnicama koje su uzimale arsenov trioksid nisu provedena.
English: Treatment with arsenic trioxide must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to arsenic trioxide treatment (see section 4.2).
Croatian: Odgoda i prilagodba doze Liječenje arsenovim trioksidom mora se privremeno prekinuti prije planiranog kraja terapije u bilo kojem trenutku ako se primijeti toksičnost 3. stupnja ili veća prema Zajedničkim kriterijima toksičnosti američkog Nacionalnog instituta za rak te procijeni da su toksični učinci možda povezani s liječenjem arsenovim trioksidom (vidjeti dio 4.2).
English: 3/µl
Croatian: 9/l.
English: Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR.
Croatian: Bolesnici u skupini liječenoj kombinacijom ATRA+ arsenov trioksid primali su kroz usta ATRA u dozi 45 mg/m2 dnevno, a u venu arsenov trioksid u dozi 0,15 mg/kg dnevno do potpune remisije.
English: In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion.
Croatian: U kliničkim ispitivanjima bolesti u fazi relapsa/refraktorne na liječenje, 40% bolesnika liječenih arsenovim trioksidom iskusilo je najmanje jedan korigirani produžetak QT (QTc) intervala veći od 500 ms.
English: If your disease responds to Arsenic trioxide Accord, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
Croatian: Arsenov trioksid Accord, započet ćete drugi ciklus liječenja od 25 doza koje se daju 5 dana u tjednu
English: Arsenic trioxide Accord contains sodium
Croatian: Lijek Arsenov trioksid Accord sadrži natrij
English: Use of Arsenic trioxide Accord
Croatian: Uporaba lijeka Arsenov trioksid Accord
English: If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, arsenic trioxide must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 gm per day may be considered.
Croatian: konvulzije, slabosti u mišićima i konfuzija), mora se odmah prekinuti primjenu arsenovog trioksida i razmotriti primjenu kelirajućih agensa s penicilaminom pri dnevnoj dozi od ≤ 1 mg na dan.
English: • Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Croatian: a koja je karakterizirana prisutnošću translokacije t(15;17) i/ili prisutnošću gena za alfa receptor za promijelocitnu leukemiju/retinoatnu kiselinu (PML/RAR-alfa).
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Croatian: Arsenov trioksid Accord 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
English: Very common (may affect more than 1 in 10 people): - fatigue (weariness), pain, fever, headache - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Croatian: - umor (klonulost), bol, vrućica, glavobolja - mučnina, povraćanje, proljev - omaglica, bolovi u mišićima, obamrlost ili trnci - osip ili svrbež, povećana razina šećera u krvi, oticanje (oteklina zbog viška tekućine) - nedostatak zraka, ubrzani srčani otkucaji, poremećeni EKG nalaz srca
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Croatian: Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekova koji produljuju QT interval, anamnezom torsade de pointes, postojećim prethodnim produljenjem QT
English: How to store Arsenic trioxide Accord
Croatian: Kako primjenjivati Arsenov trioksid Accord
English: Ventricular tachycardia
Croatian: Srčani poremećaji tahikardija
English: Arsenic trioxide Accord must be diluted with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection immediately after withdrawal from the vial.
Croatian: 50 mg/ml (5%) ili otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju odmah nakon izvlačenja lijeka iz bočice.
English: Electrocardiogram QT prolonged
Croatian: produljenje QT intervala elektrokardiograma
English: Patients with hepatic impairment Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with arsenic trioxide caution is advised in the use of arsenic trioxide in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8).
Croatian: S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja arsenovim trioksidom, potreban je oprez kod primjene arsenovog trioksida u bolesnika s oštećenjem jetre (vidjeti dio 4.4 o hepatotoksičnosti i dio 4.8).
English: Because of the potential for serious adverse reactions in breastfeeding infants from arsenic trioxide, breast-feeding must be discontinued prior to and throughout administration.
Croatian: Prije i tijekom primjene arsenovog trioksida mora se prekinuti dojenje zbog mogućnosti nastanka ozbiljnih nuspojava u dojenčadi.
English: If you experience discomfort or if you feel unwell after a Arsenic trioxide Accord injection, you should wait until the symptoms go away before driving or using machines.
Croatian: Ako osjetite nelagodu ili Vam se ne osjećate dobro nakon injekcije lijeka Arsenov trioksid Accord,