FrancophonIA/ELRC3.0 huggingface dataset:
English: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Slovenian: Zdravilo TRISENOX je treba uporabiti intravensko v odmerku 0,15 mg/kg/dan, 5 dni na teden.
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Slovenian: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when TRISENOX is co-administered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Slovenian: Zdravila, za katera je znano, da povzročajo hepatotoksične učinke Med zdravljenjem z arzenovim trioksidom lahko pride do hepatotoksičnih učinkov, zato se priporoča previdnost, če zdravilo TRISENOX odmerjate sočasno z drugimi zdravili, za katera je znano, da povzročajo hepatotoksične učinke (glejte poglavji 4.4 in 4.8).
English: Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Slovenian: Pri bolnikih v enocentrični študiji je prišlo do relapsa po 1-6 predhodnih krogih zdravljenja in pri dveh bolnikih je prišlo do relapsa po transplantaciji zarodnih celic.
English: QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Slovenian: Podaljšanje intervala Q-T lahko povzroči smrtno nevarno ventrikularno aritmijo vrste torsade de pointes.
English: 2031 GA Haarlem, The Netherlands
Slovenian: 2031 GA Haarlem, Nizozemska
English: TRISENOX 2 mg/ml concentrate for solution for infusion 6 ml concentrate in a clear, Type I borosilicate glass vial with a chlorobutyl rubber stopper (FluroTec coated plug) and an aluminium crimp cap with a plastic flip-top button.
Slovenian: TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje 6 ml koncentrata v prozorni viali iz borosilikatnega stekla tipa I s klorobutilnim gumijastim zamaškom (vložkom s prevleko FluroTec) in aluminijasto odstranljivo zaporko s plastičnim snemljivim gumbom.
English: TRISENOX is supplied in glass vials as a concentrated, clear, colourless, aqueous solution.
Slovenian: Zdravilo TRISENOX je na voljo v stekleni viali kot koncentrirana, čista, brezbarvna, vodna raztopina.
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia.
Slovenian: Nevarnost aritmije torsade de pointes je povezana s stopnjo podaljšanja intervala Q-T, sočasno uporabo zdravil za podaljšanje intervala Q-T (kot so antiaritmiki razredov Ia in III (npr. kinidin, amiodaron, sotalol, dofetilid), antipsihotikov (npr. tioridazin), antidepresivov (npr. amitriptlin), nekaterih makrolidov (npr. eritromicin), nekaterih antihistaminov (npr. terfinadin in astemizol), nekaterih kinolonskih antibiotikov (npr. sparfloksacin) in drugih zdravil, za katera je znano, da podaljšajo interval Q-T (npr. cisaprid)), pojavljanjem aritmije torsade de pointes v preteklosti, že obstoječim podaljšanjem intervala Q-T, kongestivno srčno odpovedjo, uporabo diuretikov, ki ne varčujejo s kalijem, amfotericinom B ali drugimi stanji, ki lahko povzročijo hipokaliemijo ali hipomagneziemijo.
English: There are no studies in pregnant women using TRISENOX.
Slovenian: Študij o uporabi zdravila TRISENOX pri nosečnicah ni.
English: In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with TRISENOX.
Slovenian: Med izkušnjami v obdobju trženja so pri uporabi zdravila TRISENOX za zdravljenje drugih malignosti kot APL poročali o sindromu diferenciacije, kot je sindrom retinojske kisline.
English: Intravenous use after dilution Single use only
Slovenian: intravenska uporaba po redčenju Samo za enkratno uporabo.
English: Those serious adverse reactions attributed to arsenic trioxide included APL differentiation syndrome (3), leucocytosis (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.
Slovenian: 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.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Other medicines and TRISENOX
Slovenian: Druga zdravila in zdravilo TRISENOX
English: In a phase 3, multicentre, non-inferiority 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.
Slovenian: 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,
English: The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Slovenian: Če opazite vazomotorne reakcije, lahko trajanje infundiranja podaljšate na največ 4 ure.
English: Dose delay and modification
Slovenian: Zamik in spreminjanje odmerka
English: Treatment with TRISENOX 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.
Slovenian: TRISENOX 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.
English: TRISENOX must not be mixed with, or infused through the same tube with other medicines.
Slovenian: Zdravila TRISENOX ne smete mešati z drugimi zdravili ali infundirati po isti cevki z drugimi zdravili.
English: 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.
Slovenian: Če ni porabljeno takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi med 2 in 8 °C, razen če se redčenje ni opravilo v nadzorovanih in preverjeno aseptičnih pogojih.
English: Treatment with arsenic trioxide has been associated with the development of hyperleucocytosis (≥ 10 x 103/μl) in some relapsed/refractory APL patients.
Slovenian: Hiperlevkocitoza Zdravljenje z arzenovim trioksidom je pri nekaterih bolnikih z APL v relapsu ali refraktarni fazi povezano z nastankom hiperlevkocitoze (≥ 10 x 103/μl).
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 leucocytosis.
Slovenian: 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.
English: TRISENOX 1 mg/ml concentrate for solution for infusion Type I borosilicate glass ampoule containing 10 ml of concentrate.
Slovenian: TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje Ampula iz borosilikatnega stekla tipa I, ki vsebuje 10 ml koncentrata.
English: During TRISENOX 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 leucocytosis (see section 4.4).
Slovenian: Sindrom diferenciacije Med zdravljenjem z zdravilom TRISENOX 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).
English: • any medicines that cause a decrease in magnesium or potassium in your blood (e.g. amphotericin B)
Slovenian: nekatera zdravila, ki povzročijo znižanje ravni magnezija ali kalija v krvi (npr.
English: 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 TRISENOX.
Slovenian: Vaš zdravnik bo opravil naslednje previdnostne ukrepe: - pred prvim odmerkom zdravila TRISENOX bo opravil teste, da preveriti raven kalija, magnezija,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR THE 2 MG/ML VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VIALO 2 mg/ML
English: Caution is advised when TRISENOX is co-administered with other medicinal products known to cause QT/QTc interval prolongation such as macrolide antibiotics, the antipsychotic thioridazine, or medicinal products known to cause hypokalaemia or hypomagnesaemia.
Slovenian: Pri sočasni uporabi zdravila TRISENOX 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.
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, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Slovenian: 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.
English: Single use only
Slovenian: Samo za enkratno uporabo.
English: For patients with severe, acute arsenic overdose, dialysis should be considered
Slovenian: Pri pacientih s hudim akutnim prevelikim odmerkom arzena utegne biti potrebna dializa.
English: If you have any further question on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Excipients: sodium hydroxide, hydrochloric acid, water for injections
Slovenian: Pomožne snovi: natrijev hidroksid, klorovodikova kislina, voda za injekcije.
English: Negative Positive Not evaluable
Slovenian: odsotna prisotna ni mogoče vrednotiti
English: Table 1 Recommendation for initiation of hydroxyurea WBC
Slovenian: Preglednica 1 Priporočilo za začetek zdravljenja s hidroksisečnino Število belih krvničk hidroksisečnina
English: TRISENOX must be diluted before administration.
Slovenian: Zdravilo TRISENOX morate pred uporabo razredčiti.
English: Patients who are receiving, or who have received, medicinal products known to cause hypokalaemia or hypomagnesaemia, such as diuretics or amphotericin B,
Slovenian: Pri bolnikih, ki prejemajo ali so prejemali zdravila, za katera je znano, da povzročajo hipokaliemijo ali hipomagneziemijo, kot so diuretiki ali amfotericin B, je večje tveganje nastanka aritmije torsade de pointes.
English: TRISENOX with food and drink There are no restrictions on your food or drink while you are receiving TRISENOX.
Slovenian: Zdravilo TRISENOX skupaj s hrano in pijačo Med jemanjem zdravila TRISENOX ni omejitev pri hrani in pijači.
English: 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).
Slovenian: Omejene študije reproduktivne toksičnosti arzenovega trioksida na živalih so pri dajanju odmerka, 110-krat večjega od priporočenega (mg/m2), pokazale embriotoksičnost in teratogenost (okvare nevralne cevi, anoftalmijo in mikroftalmijo).
English: Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule.
Slovenian: Ampulo potresite ali po njej potolcite, da spravite tekočino z vratu ampule v njeno telo.
English: TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Slovenian: Zdravila TRISENOX ne smete mešati ali ga istočasno dajati po isti intravenski liniji z drugimi zdravili.
English: Men should also use effective contraception during treatment with TRISENOX.
Slovenian: Med zdravljenjem z zdravilom TRISENOX morajo tudi moški uporabljati učinkovito kontracepcijo.
English: Each carton contains 10 single-use glass ampoules.
Slovenian: Ena škatla vsebuje 10 steklenih ampul za enkratno uporabo.
English: In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Slovenian: 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).
English: QT/QTc prolongation is expected during treatment with arsenic trioxide, and torsade de pointes and complete heart block have been reported.
Slovenian: 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.
English: Each carton contains 10 single-use glass vials.
Slovenian: Ena škatla vsebuje 10 steklenih vial za enkratno uporabo.
English: There is limited clinical data on the use of TRISENOX in the elderly population.
Slovenian: O uporabi zdravila TRISENOX pri starejših bolnikih je na voljo malo kliničnih podatkov.
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE 10.
English: Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles.
Slovenian: Zdravljenje skupaj traja 4 cikle, s 4 tedni zdravljenja in 4 tedni prekinitve.
English: TRISENOX contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: Zdravilo TRISENOX vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni 'brez natrija'.
English: Fertility studies have not been conducted with TRISENOX.
Slovenian: Z zdravilom TRISENOX niso opravili študij plodnosti.
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.
Slovenian: 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,
English: Thereafter, in the absence of worsening of the previous toxicity, TRISENOX might be resumed at full dosage.
Slovenian: Če ne pride do poslabšanja predhodne toksičnosti, lahko nadaljujete zdravljenje s polnim odmerkom zdravila TRISENOX.
English: 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.
Slovenian: Skupni očistek AsIII v razponu enkratnega odmerka 7-32 mg (aplicirano kot 0,15 mg/kg) je
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 TRISENOX in combination with ATRA.
Slovenian: 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 zdravilom TRISENOX v kombinaciji z ATRA.
English: TRISENOX 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.
Slovenian: APL v relapsu ali refraktarni fazi Zdravilo TRISENOX so raziskovali pri 52 bolnikih z APL, predhodno zdravljenih z antraciklinom in retinoidno terapijo, v dveh odprtih, enokračnih neprimerjalnih študijah.
English: Cases of encephalopathy were reported with treatment with arsenic trioxide.
Slovenian: Pri zdravljenju z arzenovim trioksidom so poročali o primerih encefalopatije.
English: Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Slovenian: Sistemska izpostavljenost MMAV in DMAV je bila večja pri bolnikih z okvarjenim delovanjem ledvic;
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing TRISENOX.
Slovenian: Trem bolnikom iz enocentrične študije in 15 bolnikom iz multicentrične študije so po koncu zdravljenja z zdravilom
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 TRISENOX in patients with hepatic impairment (see section 4.4 on hepatotoxicity and section 4.8).
Slovenian: Jetrna okvara 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 zdravila TRISENOX priporoča previdnost pri bolnikih z jetrno okvaro (glejte poglavje 4.4 o hepatotoksičnosti in poglavje 4.8).
English: Leucocytosis occurred in 50 % of patients with relapsed/refractory APL, as determined by haematology assessments.
Slovenian: Levkocitoza se je pojavila pri 50 % bolnikov z APL v relapsu ali refraktarni fazi.
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 - Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - okužba pljuč (pljučnica), okužba krvi - vnetje pljuč, ki povzroči bolečine v prsih in zasoplost; srčno popuščanje
English: Prior to initiating therapy with TRISENOX, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; pre-existing electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Slovenian: Pred začetkom zdravljenja z zdravilom TRISENOX morate opraviti 12-kanalni EKG in preglede ravni serumskih elektrolitov (kalija, kalcija in magnezija) ter kreatinina.
English: In one patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3.
Slovenian: Pri enem bolniku je bilo zdravljenje ustavljeno 3. dan, zaradi izrazitega podaljšanja intervala Q-Tc in anomalije elektrolitov.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Twenty-seven patients had leucocytosis (WBC  10 x 103/l) during induction, 4 of whom had values above 100,000/l.
Slovenian: 27 bolnikov je med indukcijo imelo levkocitozo (WBC ≥ 10 x 103/µl).
English: - If you have further questions, please ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
Slovenian: Ena ampula z 10 ml vsebuje 10 mg arzenovega trioksida.
English: Use of TRISENOX
Slovenian: Uporaba zdravila TRISENOX
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 (see section 4.8).
Slovenian: Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem je pri 63,2 % prišlo do hepatotoksičnih učinkov 3. ali 4. stopnje med indukcijskim ali konsolidacijskim zdravljenjem z arzenovim trioksidom v kombinaciji z ATRA (glejte poglavje 4.8).
English: TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 2 mg/ml concentrate for solution for infusion
Slovenian: TRISENOX 1 mg/ml koncentrat za raztopino za infundiranje TRISENOX 2 mg/ml koncentrat za raztopino za infundiranje
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično: ravnajte previdno
English: Marketing Authorisation Holder Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Slovenian: Teva B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: 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.
Slovenian: V ključnih študijah relapsa je bila umrljivost zaradi hemoragije, povezane z diseminirano intravaskularno koagulacijo (DIC - »disseminated intravascular coagulation«), zelo pogosta
English: Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) Induction treatment schedule
Slovenian: Na novo diagnosticirana akutna promielocitna levkemija (APL) z nizkim do srednjim tveganjem Program indukcijskega zdravljenja