natgillin/translations-raw huggingface dataset:
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), treatment with arsenic trioxide must be temporarily discontinued and high-dose steroids (dexamethasone 10 mg intravenously twice a day) must be immediately initiated, irrespective of the leukocyte count and continued for at least 3 days or longer until signs and symptoms have abated.
Na prve znakove koji bi mogli ukazivati na sindrom (neobjašnjiva vrućica, dispneja i/ili porast tjelesne težine, abnormalni nalazi auskultacije prsnog koša ili radiografske abnormalnosti), mora se privremeno prekinuti liječenje arsenovim trioksidom i mora se odmah započeti s visokim dozama steroida (deksametazon 10 mg intravenski dvaput na dan) neovisno o broju leukocita, i nastaviti s liječenjem najmanje 3 dana ili dulje sve dok se simptomi i znakovi ne povuku.
Arsenic trioxide Accord is not recommended in children and adolescents below 18 years of age.
Arsenov trioksidNe preporučuje se primjenjivati lijek Arsenov trioksid Accord u djece i adolescenata mlađih od 18 godina.
What Arsenic trioxide Accord is and what it is used for What you need to know before you use Arsenic trioxide Accord How to use Arsenic trioxide Accord Possible side effects
Što je Arsenov trioksid Accord i za što se koristi Što morate znati prije nego što primite Arsenov trioksid Accord Kako primjenjivati Arsenov trioksid Accord
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution, free from particles having a pH range of 7.7 - 8.3.
Sterilna, bistra, bezbojna, vodena otopina, bez vidljivih čestica, s pH u rasponu od 7,7 do 8,3.
In case of reappearance of hepatotoxicity, arsenic trioxide must be permanently discontinued.
U slučaju ponovne pojave hepatotoksičnosti liječenje arsenovim trioksidom mora se trajno prekinuti.
As soon as signs and symptoms have subsided, treatment with arsenic trioxide can be resumed at 50 % of the previous dose during the first 7 days.
Čim se znakovi i simptomi povuku, liječenje arsenovim trioksidom može se nastaviti pri 50% prethodne doze tijekom prvih 7 dana.
Arsenic trioxide Accord may cause harm to the foetus when used by pregnant women.
Lijek Arsenov trioksid Accord može naškoditi plodu ako ga koriste trudne žene.
If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking this product, the patient must be informed of the potential harm to the foetus.
Ako se ovaj lijek koristi tijekom trudnoće ili ako bolesnica zatrudni dok je na terapiji arsenovim trioksidom, mora se obavijestiti bolesnicu o mogućim štetnim učincima lijeka na plod.
Because Arsenic trioxide Accord can harm nursing infants, do not breast-feed while on Arsenic trioxide Accord.
S obzirom da lijek Arsenov trioksid Accord može naškoditi dojenčetu, nemojte dojiti dijete dok se liječite lijekom Arsenov trioksid Accord.
After recovery, treatment should be resumed at 50 % of the preceding daily dose.
Nakon oporavka, potrebno je nastaviti s liječenjem pri 50% prethodne dnevne doze.
In the presence of coagulopathy, the oral administration of the chelating agent dimercaptosuccinic acid succimer (DCI) 10 mg/kg or 350 mg/m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Ako je prisutna koagulopatija, preporučuje se peroralna primjena kelirajućeg agensa sukcimera dimerkaptosukcinilne kiseline (DCI) 10 mg/kg ili 350 mg/m2 svakih 8 sati tijekom 5 dana i potom svakih 12 sati tijekom 2 tjedna.
For QTc greater than 500 msec, corrective measures must be completed and the QTc reassessed with serial ECGs and, if available, a specialist advice could be sought prior to considering using arsenic trioxide.
Za QTc intervale veće od 500 ms moraju se dovršiti korektivne mjere te ponovno ispitati QTc serijskim EKG-ovima te se, ako je dostupan, može potražiti savjet specijalista prije razmatranja liječenja arsenovim trioksidom.
How to store Arsenic trioxide Accord Contents of the pack and other information
Kako čuvati Arsenov trioksid Accord Sadržaj pakiranja i druge informacije
- The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections.
- Drugi sastojci su natrijev hidroksid, kloridna kiselina, koncentrirana (za podešavanje pH) i voda za injekcije.
Biotransformation The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Metabolizam arsenovog trioksida uključuje oksidaciju arsenične kiseline (AsIII), aktivnog oblika arsenovog trioksida u arsenovu kiselinu (AsV), kao i oksidativnu metilaciju u monometilarsoničnu kiselinu (MMAV) i dimetilarseničnu kiselinu (DMAV) putem metiltransferaza, prvenstveno u jetri.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2- 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme čuvanja u primjeni i uvjeti prije primjene odgovornost su korisnika te uobičajeno ne bi smjeli biti dulji od 24 sata pri temperaturi od 2°C do 8°C, osim kada se razrjeđivanje provodi u kontroliranim i validiranim aseptičkim uvjetima.
Prior to initiating therapy with arsenic trioxide, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Prije početka liječenja arsenovim trioksidom mora se snimiti 12-kanalni EKG i odrediti elektrolite u serumu (kalij, kalcij i magnezij) te kreatinin; postojeće abnormalnosti u elektrolitima moraju se korigirati i, ako je moguće, prekinuti primjenu lijekova za koje se zna da produljuju QT interval.
Patients with risk factors of QTc prolongation or risk factors of Torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Bolesnike koji su pod rizikom od produljenja QTc intervala ili od torsade de pointes mora se nadzirati neprekidnim praćenjem kardiološkog statusa (EKG).
In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of arsenic trioxide application to the end of induction therapy in APL patients.
Radi sprječavanja razvoja sindroma diferencijacije APL-a tijekom indukcijskog liječenja, može se primjenjivati prednizon (0,5 mg/kg tjelesne težine na dan tijekom indukcijskog liječenja) od 1. dana primjene arsenovog trioksida do kraja indukcijske terapije u bolesnika s APL-om.
Patients with newly diagnosed acute promyelocytic leukaemia Your doctor will give you Arsenic trioxide Accord once every day as an infusion.
Bolesnici s novodijagnosticiranom akutnom promijelocitnom leukemijom Liječnik će Vam dati lijek Arsenov trioksid Accord svakog dana jedanput dnevno kao infuziju.
There is limited clinical data on the use of arsenic trioxide in the elderly population.
Dostupni su ograničeni podaci o primjeni arsenovog trioksida u starije populacije.
44% of relapsed/refractory APL patients experienced symptoms that could be associated with neuropathy; most were mild to moderate and were reversible upon cessation of treatment with arsenic trioxide.
44 % bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje imalo je simptome koji su se mogli povezati s neuropatijom; većina ih je bila blaga do umjerena te su postali reverzibilni nakon prekida liječenja arsenovim trioksidom.
One patient treated under a compassionate use program died from cerebral infarct due to leukocytosis, following treatment with chemotherapeutic medicinal products to lower WBC count.
Jedan bolesnik liječen u programu milosrdnog davanja lijeka umro je od moždanog infarkta zbog leukocitoze nakon liječenja kemoterapeuticima za snižavanje razine leukocita.
Alanine amino transferase increased
Pretrage porast alanin aminotransferaze
If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Ako ne nastupi produljenje QTc intervala unutar 7 dana od ponovnog početka liječenja pri smanjenoj dozi, liječenje arsenovim trioksidom može se nastaviti u dozi od 0,11 mg/kg tjelesne težine na dan tijekom drugog tjedna.
As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with arsenic trioxide should be resumed at 50 % of the previous dose during the first 7 days.
Čim se vrijednosti bilirubina i/ili SGOT-a i/ili alkalne fosfataze smanje ispod 4-struke vrijednosti gornje granice normale, liječenje arsenovim trioksidom potrebno je nastaviti s 50% prethodne doze tijekom prvih 7 dana.
The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Anorganski, liofilizirani oblik arsenovog trioksida odmah stvara hidrolitički produkt arsenične kiseline (AsIII) kad se stavi u otopinu.
Additional information about QT prolonging medicinal agents is provided in Section 4.4.
Dodatne informacije o lijekovima koji produljuju QT interval nalaze se u dijelu 4.4.
Type I transparent colorless glass vial sealed with a silicon-oil free, elastomer type, grey rubber stopper made of bromobutyl and aluminium seal with a plastic flip off cap containing 10 ml of concentrate.
I zatvorena čepom od elastomerne, sive, bromobutilne gume bez silikonskog ulja s aluminijskim prstenom i plastičnom flip-off kapicom, koja sadrži 10 ml koncentrata.
Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the recommended clinical dose (mg/m2).
Ograničena ispitivanja reproduktivne toksičnosti arsenovog trioksida na životinjama ukazuju na embriotoksičnost i teratogenost (oštećenja neuralne cijevi, anoftalmiju i mikroftalmiju) pri primjeni 110 puta većih doza od preporučene kliničke doze (mg/m2).
18-Month survival
18-mjesečni
During consolidation, ATRA was given at the same dose for periods of 2 weeks on and 2 weeks off for a total of 7 courses, and arsenic trioxide was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Tijekom konsolidacije, ATRA se davala u istoj dozi tijekom razdoblja od 2 tjedna nakon čega su slijedila 2 tjedna pauze, u ukupno 7 ciklusa, a arsenov trioksid davao se u istoj dozi 5 dana u tjednu tijekom 4 tjedna, nakon čega su slijedila 4 tjedna pauze, u ukupno 4 ciklusa.
Patients who reach an absolute QT interval value > 500 msec must be reassessed and immediate action must be taken to correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending arsenic trioxide therapy must be considered.
Bolesnici koji postignu apsolutnu vrijednost QT intervala > 500 ms moraju se ponovno podvrgnuti pregledu te je potrebno hitno djelovati kako bi se korigirali istodobni čimbenici rizika, ako postoje, te je potrebno razmotriti omjer rizika/dobrobiti nastavka liječenja naspram prekida terapijom arsenovim trioksidom.
In the case of the reappearance of symptoms arsenic trioxide should be reduced to the previous dosage.
U slučaju ponovne pojave simptoma potrebno je sniziti arsenov trioksid na prethodnu dozu.
The mechanism of action of arsenic trioxide is not completely understood.
Mehanizam djelovanja arsenovog trioksida nije potpuno razjašnjen.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili ljekarnika ukoliko uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
Caution is advised when arsenic trioxide is coadministered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalemia or hypomagnesaemia.
Preporučuje se oprez kad se arsenov trioksid primjenjuje istodobno s drugim lijekovima za koje se zna da uzrokuju produljenje QT/QTc intervala poput makrolidnih antibiotika, antipsihotika tioridazina ili lijekovima za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju.
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Produljenje QT intervala može uzrokovati ventrikularnu aritmiju tipa torsade de pointes, koja može biti smrtonosna.
Arsenic trioxide Accord must be given under the supervision of a physician experienced in the treatment of acute leukaemias.
Lijek Arsenov trioksid Accord mora se dati pod nadzorom liječnika koji je iskusan u liječenju akutnih leukemija.
Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Uključeni su bili bolesnici s novodijagnosticiranim APL-om koji je bio potvrđen prisutnošću translokacije t(15; 17) ili PML-RAR alfa metodom RT-PCR ili mikro raspršenom nuklearnom distribucijom PML-a u leukemijskim stanicama.
In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with arsenic trioxide.
U kontrolnom praćenju nakon konsolidacije, 7 je bolesnika u monocentričnom i 18 u multicentričnom ispitivanju primilo nastavak terapije održavanja arsenovim trioksidom.
Arsenic trioxide must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
Arsenov trioksid mora se primjenjivati intravenski pri fiksnoj dozi od 0,15 mg/kg/dan, svaki dan, sve dok se ne postigne potpuna remisija (manje od 5% blasta prisutnih u stanicama koštane srži bez dokaza leukemičnih stanica).
If you have any further question on the use of this medicine, ask your doctor or pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
Hyperleukocytosis was never treated with additional chemotherapy and resolved on continuation of arsenic trioxide.
Hiperleukocitoza nikad nije bila liječena dodatnom kemoterapijom te se povukla pri nastavku liječenja arsenovim trioksidom.
Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 mL/min) or moderate renal impairment (creatinine clearance of 30-49 mL/min).
Oštećenje bubrega Plazmatski klirens AsIII nije bio izmijenjen u bolesnika s blagim oštećenjem bubrega (klirens kreatinina od 50 do 80 ml/min) ili umjerenim oštećenjem bubrega (klirens kreatinina od 30 do 49 ml/min).
Women of childbearing potential and men must use effective contraception during treatment with arsenic trioxide.
Žene reproduktivne dobi i muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja arsenovim trioksidom.
In post authorisation experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with arsenic trioxide.
Prema iskustvu nakon stavljanja lijeka u promet, sindrom diferencijacije, poput sindroma retinoatne kiseline, bio je zabilježen i kada su arsenovim trioksidom liječene druge maligne bolesti osim APL-a.
Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Muškarci također moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Arsenov trioksid
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
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.
Arsenic trioxide has no or negligible influence on the ability to drive and use machines.
Arsenov trioksid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RARα conversion to normal are shown in table 5 below.
Citogenetska potvrda konverzije u normalni genotip i detekcija konverzije PML/RARα u normalnu reakcijom obrnute transkriptaze - lančane polimeraze (RT-PCR), prikazane su u tablici 5 u nastavku.
During arsenic trioxide treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis (see section 4.4).
Tijekom liječenja arsenovim trioksidom, 14 od 52 bolesnika s APL-om u fazi relapsa imali su jedan ili više simptoma sindroma diferencijacije APL-a, koji karakteriziraju vrućica, dispneja, porast tjelesne težine, plućni infiltrati i pleuralni ili perikardijalni izljevi, s leukocitozom ili bez nje (vidjeti dio 4.4).
Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing arsenic trioxide.
Tri bolesnika iz monocentričnog ispitivanja i 15 bolesnika iz multicentričnog ispitivanja podvrgnuli su se transplantaciji matičnih stanica nakon dovršetka liječenja arsenovim trioksidom.
Baseline white blood cell (WBC) counts did not correlate with development of leukocytosis on study, and WBC counts during consolidation therapy were not as high as during induction.
Početne vrijednosti leukocita nisu korelirale s razvojem leukocitoze u ispitivanju, a broj leukocita tijekom konsolidacijske terapije nije bio tako visok kao tijekom indukcije.
Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10%), which is consistent with the early mortality reported in the literature.
U pivotalnim je ispitivanjima bolesti u fazi relapsa vrlo često bio prijavljivan (> 10%) mortalitet zbog krvarenja povezanog s diseminiranom intravaskularnom koagulacijom (DIK), što je u skladu s preuranjenim mortalitetom opisanim u literaturi.
The influence of arsenic trioxide on the efficacy of other antileukaemic medicinal products is unknown.
Drugi lijekovi protiv leukemije Utjecaj arsenovog trioksida na djelotvornost drugih lijekova protiv leukemije nije poznat.
If this happens, treatment with Arsenic trioxide Accord must be stopped immediately and your doctor will treat the arsenic overdose.
Arsenov trioksid Accord mora se odmah prekinuti, a Vaš će liječnik liječiti predoziranje arsenom.
Twenty relapsed/refractory APL patients (50 %) experienced leukocytosis; however, in all these patients, the WBC count was declining or had normalized by the time of bone marrow remission and cytotoxic chemotherapy or leukopheresis was not required.
Dvadeset bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje (50%), imalo je leukocitozu; međutim, kod svih tih bolesnika broj leukocita bio je u padu ili se normalizirao do vremena remisije koštane srži pa citotoksična terapija ili leukofereza nije bila potrebna.
Arsenic trioxide Accord is expected to have no or negligible influence on your ability to drive and use machines.
Za lijek Arsenov trioksid Accord očekuje se da ne utječe ili da zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Jedan je bolesnik (koji je primao više lijekova istodobno, uključujući i amfotericin B) imao asimptomatsku torsade de pointes tijekom indukcijske terapije arsenovim trioksidom za relaps APL-a.
Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Lijek Arsenov trioksid Accord mora se razrijediti otopinom koja sadrži glukozu ili natrijev klorid.
Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, liječenje arsenovim trioksidom može se nastaviti u punoj dozi.
Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leukocytosis (3), prolonged QT interval (4, 1 with torsade de pointes), atrial fibrillation/atrial flutter (1), hyperglycaemia (2) and a variety of serious adverse reactions related to haemorrhage, infections, pain, diarrhoea, nausea.
Te ozbiljne nuspojave pripisane arsenovom trioksidu uključivale su sindrom diferencijacije APL-a (3), leukocitozu (3), produljeni QT interval (4, 1 s torsade de pointes), fibrilaciju atrija/undulaciju atrija (1), hiperglikemiju (2) i razne ozbiljne nuspojave povezane s krvarenjem, infekcijama, boli, proljevom, mučninom.
In your first treatment cycle, you may be treated every day up to 60 days at most or until your doctor determines that your disease is better.
Vašem prvom ciklusu liječenja možda ćete dobivati lijek Arsenov trioksid Accord svaki dan, do najviše 60 dana ili dok liječnik ne utvrdi da Vam je bolje.
Arsenic trioxide Accord must then be diluted immediately 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.
Lijek Arsenov trioksid Accord mora se odmah razrijediti pomoću 100 do 250 ml otopine glukoze za injekciju 50 mg/ml (5 %) ili otopine natrijevog klorida 9 mg/ml (0,9 %) za injekciju.
Arsenic trioxide Accord must not be mixed with, or infused through the same tube with other medicines.
Lijek Arsenov trioksid Accord ne smije se miješati ili davati infuzijom kroz istu cjevčicu s drugim lijekovima.
- difficulty in breathing - coughing - chest pain - fever
- otežano disanje - kašalj - bolovi u prsima
Cytotoxic: handle with caution.
Citotoksično: rukovati s oprezom
- If you have further questions, please ask your doctor or your pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
In your first treatment cycle, you may be treated every day up to 50 days at most or until your doctor determines that your disease is better.
Vašem prvom ciklusu liječenja možda ćete dobivati Arsenov trioksid Accord svaki dan, do najviše 50 dana ili dok liječnik ne utvrdi da Vam je bolje.
In newly diagnosed patients with low to intermediate risk APL leukocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika razvila se leukocitoza tijekom indukcijske terapije u 35 od 74 (47%)