natgillin/translations-raw huggingface dataset:
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).
Na novo diagnosticirani bolniki z APL, pri katerih tveganje ni veliko Arzenov trioksid so raziskovali pri 77 na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem v nadzorovani, randomizirani, neinferiorni klinični študiji 3. faze, v kateri so primerjali učinkovitost in varnost arzenovega trioksida v kombinaciji z vse-trans-retinojsko kislino (ATRA) z učinkovitostjo in varnostjo ATRA + kemoterapije (npr. idarubicin in mitoksantron) (študija APL0406).
Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
Arzenov trioksid je treba uporabiti intravensko v odmerku 0,15 mg/kg/dan vsak dan, dokler ni dosežena popolna remisija.
Hyperglycaemia
Hiperlevkocitoza
Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Arzenov trioksid je treba uporabiti intravensko v odmerku 0,15 mg/kg/dan, 5 dni na teden.
In the case of the reappearance of symptoms arsenic trioxide should be reduced to the previous dosage.
Če znova pride do simptomov, zmanjšajte odmerek arzenovega trioksida na prejšnji odmerek.
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.
Med resne neželene učinke, ki so jih pripisali arzenovemu trioksidu, so spadali sindrom diferenciacije APL (3), levkocitoza (3), podaljšan interval Q-T (4, 1 z aritmijo torsade de pointes), atrijska fibrilacija/atrijska undulacija (1), hiperglikemija (2) in razni resni neželeni učinki, povezani s hemoragijo, okužbami, bolečinami, drisko in navzeo.
- difficulty in breathing - coughing - chest pain - fever
- bolečine v prsih - vročina
There are no studies in pregnant women using arsenic trioxide.
Študij o uporabi arzenovega trioksida pri nosečnicah ni.
The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen.
Učinkovina zdravila Arzenov trioksidAccord, arzenov trioksid, je humani kancerogen.
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.
Sindrom aktivacije levkocitov (sindrom diferenciacije APL) Pri 27 % bolnikov z APL v relapsu ali refraktarni fazi, ki so jih zdravili z arzenovim trioksidom, so se pojavili simptomi, podobni sindromu, imenovanemu retinojska kislina - akutna promielocitna levkemija (RA-APL) ali sindrom diferenciacije APL, za katerega so značilni zvišana telesna temperatura, dispneja, pridobivanje telesne mase, pljučni infiltrati in plevralni ali perikardialni izlivi, z levkocitozo ali brez nje.
Pulmonary alveolar haemorrhage
plevralni izliv plevritične bolečine pljučna alveolarna hemoragija pnevmonitis
Each course of consolidation was initiated at hematological recovery from the previous course defined as absolute neutrophil count >1.5×109/L and platelets >100×109/L.
določenem kot absolutno število nevtrofilcev > 1,5×109/l in trombocitov > 100×109/l.
Arsenic trioxide Accord must be diluted before administration.
Zdravilo Arzenov trioksid Accord morate pred uporabo razredčiti.
APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
APL = akutna promielocitna levkemija; ATRA = vse-trans-retinojska kislina APL v relapsu ali refraktarni fazi
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.
Po pridobitvi dovoljenja za promet z zdravilom so pri uporabi arzenovega trioksida za zdravljenje drugih malignosti kot APL poročali o sindromu diferenciacije, kot je sindrom retinojske kisline.
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).
Zdravila, za katera je znano, da povzročajo hepatotoksične učinke Med zdravljenjem z arzenovim trioksidom lahko pride do hepatotoksičnih učinkov, zato se priporoča previdnost, če arzenov trioksid odmerjate sočasno z drugimi zdravili, za katera je znano, da povzročajo hepatotoksične učinke (glejte poglavji 4.4 in 4.8).
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).
Sindrom diferenciacije Med zdravljenjem z arzenovim trioksidom je 14 od 52 bolnikov v študijah akutne promielocitne levkemije v relapsu imelo enega ali več znakov sindroma diferenciacije APL, za katerega so značilni zvišana telesna temperatura, dispneja, pridobivanje telesne mase, pljučni infiltrati in plevralni ali perikardialni izlivi, z levkocitozo ali brez nje (glejte poglavje 4.4).
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.
Pri sočasni uporabi arzenovega trioksida in drugih zdravil, za katere je znano, da povzročajo podaljšanje intervala Q-T/QTc, kot so makrolidni antibiotiki, antipsihotik tioridazin ali zdravila, za katera je znano, da povzročajo hipokaliemijo ali hipomagneziemijo, svetujemo previdnost.
In a phase 3, multicenter, noninferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
V multicentričnem, neinferiornem preskušanju 3. faze, v kateri so primerjali vse-transretinojsko kislino (ATRA) v kombinaciji s kemoterapijo in ATRA v kombinaciji z arzenovim trioksidom pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem (študija APL0406; glejte tudi poglavje 5.1), so bili pri bolnikih, ki so bili zdravljeni z arzenovim trioksidom, ugotovljeni resni neželeni učinki, vključno s hepatotoksičnostjo, trombocitopenijo,
Do not use Arsenic trioxide Accord
Ne uporabljajte zdravila Arzenov trioksid Accord
Arsenic trioxide Accord is a concentrate for solution for infusion.
Zdravilo Arzenov trioksid Accord je koncentrat za raztopino za infundiranje.
You must talk to your doctor or nurse before using Arsenic trioxide Accord, if - you have impaired kidney function.
Pred začetkom uporabe zdravila Arzenov trioksid Accord se morate posvetovati z zdravnikom ali medicinsko sestro, če: imate okvarjeno delovanje ledvic, imate kakršne koli težave z jetri.
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.
Nevarnost aritmije torsade de pointes je povezana s stopnjo podaljšanja intervala Q-T, sočasne uporabe zdravil za podaljšanje intervala Q-T, pojavljanjem aritmije torsade de pointes v preteklosti, že obstoječim podaljšanjem intervala Q-T, kongestivno srčno odpovedjo, uporabo diuretikov, ki ne varčujejo s kalijem ali drugimi stanji, ki lahko povzročijo hipokaliemijo ali hipomagneziemijo.
Arsenic trioxide Accord must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Zdravila Arzenov trioksid Accord ne smete mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili.
Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/µl) during induction, 4 of whom had values above 100,000/µl.
27 bolnikov je med indukcijo imelo levkocitozo (WBC ≥ 10 x 103/µl).
are 32 hours and 70 hours, respectively.
ur in presnovka DMAV 70 ur.
How to store Arsenic trioxide Accord Contents of the pack and other information
5 Shranjevanje zdravila Arzenov trioksid Accord Vsebina pakiranja in dodatne informacije
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.
Zdravljenje z arzenovim trioksidom morate pred načrtovanim koncem terapije prekiniti v katerem koli trenutku, ko opazite hepatotoksičnost 3. stopnje ali več po merilih pogostih toksičnosti Nacionalnega inštituta za rakava obolenja.
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
Na novo diagnosticirana akutna promielocitna levkemija (APL) z nizkim do srednjim tveganjem
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
lahko trajanje infundiranja podaljšate na največ 4 ure.
Since no data are available across all renal impairment groups, caution is advised in the use of arsenic trioxide in patients with renal impairment.
Ker ni na voljo podatkov za nobeno skupino bolnikov z ledvično okvaro, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z ledvično okvaro.
Leukocytosis occurred in 50% of patients with relapsed/refractory APL, as determined by haematology assessments.
Levkocitoza se je pojavila pri 50 % bolnikov z APL v relapsu ali refraktarni fazi.
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 zdravnik bo opravil naslednje previdnostne ukrepe: - pred prvim odmerkom zdravila Arzenov trioksid Accord bo opravil teste, da preveri raven kalija,
QT/QTc prolongation is expected during treatment with arsenic trioxide, and Torsade de pointes and complete heart block have been reported.
Med zdravljenjem z arzenovim trioksidom lahko pričakujete podaljšanje intervala Q-T/Q-Tc, poročali pa so tudi o aritmiji Torsade de pointes in popolnem srčnem bloku.
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).
Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je pri 35 od 74 (47 %) prišlo do levkocitoze med indukcijskim zdravljenjem (glejte poglavje 4.8).
Other medicines and Arsenic trioxide Accord
Druga zdravila in zdravilo Arzenov trioksid Accord
- fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
- palpitacija (občutek močnega bitja srca, ki ga lahko čutite v prsnem košu)
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.
Bolniki s pomembnimi aritmijami, anomalijami EKG (kongenitalni sindrom podaljšanega intervala Q-T, v preteklosti ali sedanjosti prisotna pomembna prekatna ali atrijska tahiaritmija, klinično pomembna mirujoča bradikardija (< 50 utripov na minuto), QTc > 450 msec pri pregledu EKG,
Arsenic trioxide Accord must not be mixed with, or infused through the same tube with other medicines.
Zdravila Arzenov trioksid Accord ne smete mešati z drugimi zdravili ali infundirati po isti cevki z drugimi zdravili.
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.
Rok uporabnosti po redčenju: kemijska in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur pri temperaturi 25 °C in 48 ur pri temperaturah 2 °C - 8 °C.
- If you have further questions, please ask your doctor or your pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The total clearance of AsIII over the single dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 L/h and the renal clearance is 9 L/h.
Skupni očistek AsIII v razponu enkratnega odmerka 7-32 mg (aplicirano kot 0,15 mg/kg) je
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.
Bolniki v skupini ATRA + arzenov trioksid so prejemali peroralno dnevni odmerek ATRA 45 mg/m2 in i.v.
Patients in the first study received a median dose of 0.16 mg/kg/day of arsenic trioxide (range 0.06
Bolniki v prvi študiji so prejemali mediano odmerka 0,16 mg/kg arzenovega trioksida na dan (v obsegu od 0,06 do 0,20 mg/kg/dan), bolniki v multicentrični študiji pa fiksni odmerek 0,15 mg/kg/dan.
What Arsenic trioxide Accord looks like and contents of the pack
Izgled zdravila Arzenov trioksid Accord in vsebina pakiranja
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.
Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je pri 63,2 % prišlo do hepatotoksičnih učinkov stopnje 3 ali 4 med indukcijskim ali konsolidacijskim zdravljenjem z arzenovim trioksidom v kombinaciji z ATRA.
One ml contains 1 mg of arsenic trioxide.
En ml vsebuje 1 mg arzenovega trioksida.
The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated.
Multicentrična študija je vključevala 5 pediatričnih bolnikov (starih < 18 let).
Thereafter, in the absence of worsening of the previous toxicity, arsenic trioxide might be resumed at full dosage.
Če ne pride do poslabšanja predhodne toksičnosti, lahko nadaljujete zdravljenje s polnim odmerkom arzenovega trioksida.
Arsenic trioxide Accord contains sodium
Zdravilo Arzenov trioksid Accord vsebuje natrij
- If you get any side effects, talk to your doctor or pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
One ml of concentrate for solution for infusion contains 1 mg of arsenic trioxide.
En ml koncentrata za raztopino za infundiranje vsebuje 1 mg arzenovega trioksida.
One vial of 10 ml contains 10 mg of arsenic trioxide.
Ena viala (10 ml) vsebuje 10 mg arzenovega trioksida.
*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
*V študiji CALGB C9710 so poročali o 2 primerih zvečane GGT stopnje≥ 3 med 200 bolniki, ki so prejeli konsolidirane cikle arzenovega trioksida (cikel 1 in cikel 2) v primerjavi z nobenim v kontrolnem kraku.
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.
V ključnih študijah relapsa je bila umrljivost zaradi hemoragije, povezane z diseminirano intravaskularno koagulacijo (DIC - »disseminated intravascular coagulation«), zelo pogosta
Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population.
V tej skupini z APL v relapsu ali refraktarni fazi so bili resni neželeni učinki pogosti (1-10 %) in pričakovani.
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).
Ker ni na voljo podatkov za nobeno skupino bolnikov z jetrno okvaro in lahko med zdravljenjem z arzenovim trioksidom pride do hepatotoksičnih učinkov, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z jetrno okvaro (glejte poglavji 4.4 in 4.8).
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.
Pred začetkom zdravljenja z arzenovim trioksidom morate opraviti 12-kanalni EKG in preglede ravni serumskih elektrolitov (kalija, kalcija in magnezija) ter kreatinina.
Cytogenetics after arsenic trioxide therapy
Citogenetika po zdravljenju z arzenovim trioksidom
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.
Ni ugotovljene povezave med osnovno vrednostjo števila belih krvnih celic (WBC - white blood cell) in razvojem hiperlevkocitoze ali med osnovno in najvišjo vrednostjo WBC. Hiperlevkocitoze niso nikoli zdravili z dodatno kemoterapijo in ob nadaljevanju zdravljenja z arzenovim trioksidom ni bila ozdravljena.
Fertility studies have not been conducted with arsenic trioxide.
Z arzenovim trioksidom niso opravili študij plodnosti.
There is limited clinical data on the use of arsenic trioxide in the elderly population.
O uporabi arzenovega trioksida pri starejših bolnikih je na voljo malo kliničnih podatkov.
Use of Arsenic trioxide Accord
Uporaba zdravila Arzenov trioksid Accord
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
- okužba pljuč (pljučnica), okužba krvi - vnetje pljuč, ki povzroči bolečine v prsih in zasoplost; srčno popuščanje
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Arzenov trioksid Accord 1 mg/ml koncentrat za raztopino za infundiranje
The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24
Pentavalentni presnovki, MMAV in DMAV, se v plazmi pokažejo počasi (približno 10-24 ur po prvem dajanju arzenovega trioksida), vendar se zaradi daljšega razpolovnega časa bolj nalagajo po več odmerkih kot AsIII.
Thereafter, in absence of worsening of the previous toxicity, arsenic trioxide should be resumed at full dosage.
Če se prejšnja toksičnost ne poslabša, nadaljujte zdravljenje s polnim odmerkom arzenovega trioksida.
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.
Za preprečitev nastanka sindroma diferenciacije APL med indukcijskim zdravljenjem, lahko odmerite prednizon (0,5 mg/kg telesne mase na dan med indukcijskim zdravljenjem) od 1. dne odmerjanja arzenovega trioksida do konca indukcijskega zdravljenja pri bolnikih z APL. Priporočamo, da med zdravljenjem s steroidi ne začnete kemoterapije, kajti nimamo izkušenj s skupno uporabo steroidov in kemoterapije med zdravljenjem sindroma aktivacije levkocitov, do katerega pride zaradi arzenovega trioksida.
If you are able to become pregnant, you must use effective birth control during treatment with Arsenic trioxide Accord.
Če lahko zanosite, morate med zdravljenjem z zdravilom Arzenov trioksid Accord uporabljati zanesljivo kontracepcijsko sredstvo.
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.
Med konsolidacijo so ATRA dajali v enakem odmerku v času 2 tednov, ki sta jima sledila 2 tedna brez prejetega odmerka, pri čemer je bilo skupaj izvedenih 7 ciklov.
Pleural effusion
Okvarjeno delovanje ledvic
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).
Ker ni na voljo podatkov za nobeno skupino bolnikov z jetrno okvaro in lahko med zdravljenjem z arzenovim trioksidom pride do hepatotoksičnih učinkov, se pri uporabi arzenovega trioksida priporoča previdnost pri bolnikih z jetrno okvaro (glejte poglavje 4.4 o hepatotoksičnosti in poglavje 4.8).
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
- omotica, mišične bolečine, odrevenelost ali mravljinčenje - izpuščaji ali srbečica - zvišana raven sladkorja v krvi, edem (oteklina zaradi prevelike količine tekočine) - zasoplost, hiter srčni utrip, nenormalen EKG - znižana koncentracija kalija ali magnezija v krvi, neobičajni rezultati testov delovanja jeter,
Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Arzenov trioksid Accord 1 mg/ml koncentrat za raztopino za infundiranje arzenov trioksid
Pleuritic pain
OVOJNINAH VIALA
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
Pogostnosti neželenih učinkov arzenovega trioksida v kliničnih preskušanjih pri 52 bolnikih z
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.
mitoksantron v odmerku 10 mg/m2 ob dneh 1 do 5 in znova ATRA v odmerku 45 mg/m2 dnevno 15 dni ter na koncu en odmerek idarubicina 12 mg/m2 in ATRA v odmerku 45 mg/m2 dnevno
APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
APL v relapsu ali refraktarni fazi so v preglednici 2 opredeljene kot: (zelo pogosti ≥ 1/10), (pogosti
During therapy with arsenic trioxide, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Med zdravljenjem z arzenovim trioksidom morate vzdrževati koncentracijo kalija nad 4 mEq/l in koncentracijo magnezija nad 1,8 mg/dl. Bolnike, ki dosežejo absolutno vrednost intervala Q-T > 500 ms, morate ponovno pregledati in nemudoma ukrepati, da bi popravili morebitne spremljajoče dejavnike tveganja.
Men should also use effective contraception during treatment with Arsenic trioxide Accord.
Med zdravljenjem z zdravilom Arzenov trioksid Accord morajo tudi moški uporabljati učinkovito kontracepcijo.