natgillin/translations-raw huggingface dataset:
Complete remission (CR) was defined as the absence of visible leukaemic cells in the bone marrow and peripheral recovery of platelets and white blood cells.
Popolna remisija (CR - »complete remission«) je bila opredeljena kot odsotnost vidnih levkemičnih celic v kostnem mozgu ter periferna obnovitev krvnih ploščic in belih krvnih celic.
Substances that are substrates for these P450 enzymes are not expected to interact with TRISENOX.
Za učinkovine, ki so substrati encimov P450, se ne pričakuje, da bodo medsebojno delovale z zdravilom TRISENOX.
Electrocardiograms must be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Elektrokardiogram morate opraviti dvakrat tedensko, pri klinično nestabilnih bolnikih med indukcijskim in konsolidacijskim zdravljenjem pa tudi pogosteje.
No clear trend toward an increase in systemic exposure to AsIII, AsV, MMAV or DMAV was observed with decreasing level of hepatic function as assessed by dose-normalized (per mg dose) AUC.
Jasne težnje po zvečanju sistemske izpostavljenosti AsIII, AsV, MMAV ali DMAV ni bilo opaziti z zmanjšanjem ravni delovanja jeter pri oceni AUC z normaliziranim odmerkom (na mg odmerka).
For ECG, electrolytes abnormalities and hepatotoxicity see section 4.4.
Za anomalije EKG in elektrolitov ter hepatotoksičnost glejte poglavje 4.4.
QT interval prolongation
Podaljšanje intervala Q-T
ATRA + TRISENOX (n = 77)
TRISENOX (n = 77)
In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
In vitro encimske študije človeških jetrnih mikrosomov so razkrile, da arzenov trioksid ne vpliva zaviralno na substrate večjih encimov citokroma P450 kot so 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6,
TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
Zdravilo TRISENOX je indicirano za indukcijo remisije in konsolidacijo pri odraslih bolnikih z:
TRISENOX is for single use only and any unused portions of each ampoule or of each vial must be discarded properly.
Zdravilo TRISENOX je namenjeno samo za enkratno uporabo in vso neuporabljeno zdravilo iz vsake ampule ali vsake viale morate ustrezno zavreči.
- If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation), your heart will be monitored continuously.
- Če obstaja tveganje določene vrste nenavadnega bitja srca (npr. aritmija torsade de pointes ali podaljšanja Q-Tc), bo vaše srce pod neprestanim nadzorom.
What TRISENOX is and what it is used for What you need to know before you are given TRISENOX How TRISENOX is given
Kaj je zdravilo TRISENOX in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo TRISENOX Kako se daje zdravilo TRISENOX
Consolidation schedule
Program konsolidacije
If complete remission has not occurred by day 60, dosing must be discontinued.
Če do popolne remisije ne pride do 60. dne, je treba z odmerjanjem prekiniti.
No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted.
Uradne ocene farmakokinetičnih interakcij med zdravilom TRISENOX in drugimi zdravili niso izvedli.
If your doctor or nurse gives you more TRISENOX than he/she should You may experience convulsions, muscle weakness and confusion.
Če sta vam zdravnik ali medicinska sestra dala večji odmerek zdravila TRISENOX, kot bi smela Morda boste čutili krče, mišično slabotnost in zmedenost.
See section 2 “TRISENOX contains sodium”.
Glejte poglavje 2, ‘Zdravilo TRISENOX vsebuje natrij'.
*In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the 200 patients who received TRISENOX consolidation cycles (cycle 1 and cycle 2) versus none in the control arm.
*V študiji CALGB C9710 so poročali o 2 primerih zvečane GGT stopnje≥ 3 med 200 bolniki, ki so prejeli konsolidirane cikle zdravila TRISENOX (cikel 1 in cikel 2) v primerjavi z nobenim v kontrolnem kraku.
If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Če ste noseči ali med zdravljenjem z zdravilom TRISENOX zanosite, se morate posvetovati z zdravnikom.
The effect of these medicines on your heartbeat can be made worse by TRISENOX.
Učinek teh zdravil na vaš srčni ritem se lahko z uporabo zdravila TRISENOX še okrepi.
What TRISENOX is and what it is used for
Kaj je zdravilo TRISENOX in za kaj ga uporabljamo
- Your doctor may monitor your health during and after treatment, since arsenic trioxide, the active substance in TRISENOX, may cause other cancers.
- Zdravnik bo tako med zdravljenjem kot po njem morda nadzoroval vaše zdravje, saj lahko arzenov trioksid, učinkovina v zdravilu TRISENOX, povzroči druge oblike raka.
Now press your thumb on the coloured point and break the ampoule by holding firmly the body of the ampoule with the other hand.
Sedaj na obarvano točko pritisnite s palcem in vrat ampule odlomite, medtem ko jo z drugo roko čvrsto držite za telo.
- You should have an electrical recording of the heart (electrocardiogram ECG) performed before your first dose.
- Pred prvim odmerkom morate opraviti tudi električni posnetek srca (EKG - elektrokardiogram).
Children and adolescents TRISENOX is not recommended in children and adolescents below 18 years of age.
Zdravilo TRISENOX ni primerno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
32 days
32 dni
Your doctor will decide exactly how long you must continue on therapy with TRISENOX.
Zdravnik bo določil, kako dolgo morate prejemati zdravilo TRISENOX.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX27.
Hepatotoxicity (grade 3-4)
Hepatotoksičnost (3.-4. stopnje)
Patients who experience a recurrence of toxicity must be removed from treatment.
Pri bolnikih, pri katerih ponovno nastopi toksičnost, morate zdravljenje prekiniti.
TRISENOX must be administered intravenously over 1-2 hours.
Zdravilo TRISENOX morate dajati intravensko 1-2 uri.
In these studies, leucocytosis was not treated with chemotherapeutic medicinal products.
Levkocitoze v teh študijah niso zdravili s kemoterapevtiki.
TRISENOX was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
Zdravilo TRISENOX so dajali intravensko v trajanju 1-2 uri, dokler kostni mozeg ni bil brez levkemičnih celic, vendar največ 60 dni.
The most commonly reported reactions were hyperglycaemia, hypokalaemia, neutropenia, and increased alanine amino transferase (ALT).
Najpogostejši učinki so bili hipoglikemija, hipokaliemija, nevtropenija in zvečana raven alanin-aminotransferaze (ALT).
TRISENOX may cause harm to the foetus when used by pregnant women.
TRISENOX lahko škoduje plodu, če ga jemljejo nosečnice.
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.
Če to zdravilo uporabljajo nosečnice ali če bolnice med jemanjem zdravila zanosijo, jih morate obvestiti o morebitnem tveganju za plod.
If complete remission has not occurred by day 50, dosing must be discontinued.
Če do popolne remisije ne pride do 50. dne, morate odmerjanje prekiniti.
After recovery, treatment should be resumed at 50 % of the preceding daily dose.
Po okrevanju je treba zdravljenje nadaljevati s 50 % prejšnjega dnevnega odmerka.
The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Anorganska liofilizirana oblika arzenovega trioksida dodana raztopini takoj oblikuje produkt hidrolize arzenasto kislino (AsIII).
For instructions on preparation of the medicinal product before administration, see section 6.6.
Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.
Thereafter, penicillamine at a daily dose ≤ 1 g per day may be given.
Nato lahko uporabite penicilamin v odmerkih po ≤ 1 gram na dan.
As soon as signs and symptoms have subsided, treatment with TRISENOX can be resumed at 50 % of the previous dose during the first 7 days.
Takoj ko izginejo znaki in simptomi, lahko nadaljujete zdravljenje z zdravilom TRISENOX s 50 % prejšnjega odmerka v prvih 7 dneh.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Conventional Cytogenetics [t(15;17)] Absent
Navadna citogenetika [t(15;17)]
Any unused product, any items that come into contact with the product and waste material must be disposed of in accordance with local requirements.
Neuporabljeno zdravilo, vse predmete, ki pridejo v stik z zdravilom, in odpadni material zavrzite v skladu z lokalnimi predpisi.
TRISENOX must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and the special monitoring procedures described in section 4.4 must be followed.
Zdravilo TRISENOX morate uporabljati pod nadzorom zdravnikov, izkušenih v zdravljenju akutnih levkemij in treba je upoštevati posebne nadzorne postopke, opisane v poglavju 4.4.
Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
Od 7 bolnikov, mlajših od 18 let (razpon od 5 do 16 let), ki so prejemali zdravilo TRISENOX v priporočenem odmerku 0,15 mg/kg/dan, so pri 5 dosegli popoln odziv (glejte poglavje 4.2).
The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
Metilirani presnovki AsIII (MMAV, DMAV) se pretežno izločijo s sečem.
Wernicke encephalopathy after arsenic trioxide treatment was reported in patients with vitamin B1 deficiency.
O Wernickejevi encefalopatiji so po zdravljenju z arzenovim trioksidom poročali pri bolnikih s pomanjkanjem vitamina B1.
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.
V prvem ciklu zdravljenja boste prejemali zdravilo največ 60 dni ali dokler zdravnik ne določi, da se je vaše stanje izboljšalo.
This is probably due to the confounding of adverse events by the uncontrolled disease process early on in the treatment course and the myriad concomitant medicinal products required to control symptoms and morbidity.
Razlog za to je najbrž neločevanje neželenih učinkov od bolezenskega procesa v začetku zdravljenja in velikega števila zdravil, potrebnih za nadzor bolezenskih simptomov in obolevnosti.
If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
Če se to zgodi, morate nemudoma prekiniti zdravljenje z zdravilom TRISENOX in zdravnik vas bo zdravil zaradi prevelikega odmerka arzena.
The mechanism of action of TRISENOX is not completely understood.
Načina delovanja zdravila TRISENOX ne razumemo povsem.
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.
V prvem ciklu zdravljenja boste prejemali zdravilo največ 50 dni ali dokler zdravnik ne določi, da se je vaše stanje izboljšalo.
Arsenic trioxide can cause QT interval prolongation (see section 4.4).
Arzenov trioksid lahko povzroči podaljšanje intervala Q-T (glejte poglavje 4.4).
Concentrate for solution for infusion 10 ampoules
koncentrat za raztopino za infundiranje 10 ampul
• some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
nekatere vrste antiaritmikov (zdravila, ki se uporabljajo za popravek nepravilnega srčnega utripa, npr. kinidin, amiodaron, sotalol, dofetilid)
TRISENOX must be diluted with a solution containing glucose or a solution containing sodium chloride.
Zdravilo TRISENOX se mora razredčiti z raztopino, ki vsebuje glukozo, ali raztopino, ki vsebuje natrijev klorid.
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 TRISENOX.
V nadaljevalnem zdravljenju po konsolidaciji so 7 bolnikom iz enocentrične študije in 18 bolnikom iz multicentrične študije odredili nadaljnje zdravljenje z zdravilom TRISENOX.
No formal carcinogenicity studies of arsenic trioxide have been performed.
Uradnih študij kancerogenosti arzenovega trioksida niso opravili.
However, toxic effects resolved with temporary discontinuation of either TRISENOX, ATRA or both (see section 4.4).
Toda toksični učinki so izginili s prekinitvijo uporabe zdravila TRISENOX, ATRA ali obeh (glejte poglavje 4.4).
The duration of treatment with penicillamine must be evaluated taking into account the urinary arsenic laboratory values.
Trajanje zdravljenja s penicilaminom je treba določiti glede na laboratorijske vrednosti arzena v seču.
The experience in patients with severe renal impairment is insufficient to determine if dose adjustment is required.
Izkušnje pri bolnikih s hudo ledvično okvaro ne zadoščajo za ugotovitev, ali je potrebno prilagoditi odmerek.
The use of TRISENOX in patients on dialysis has not been studied.
Uporabe zdravila TRISENOX pri bolnikih na dializi niso preučili.
Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom ali farmacevtom preden vzamete katerokoli zdravilo.
The arsenic in TRISENOX passes into breast milk.
Arzen v zdravilu TRISENOX prehaja v materino mleko.
The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Pediatrična populacija Varnost in učinkovitost zdravila TRISENOX pri otrocih, mlajših od 17 let, nista bili dokazani.
If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with TRISENOX can be resumed at 0.11 mg/kg body weight per day for a second week.
Če se podaljšanje intervala Q-Tc ne ponovi v 7 dneh po vnovičnem začetku zdravljenja z zmanjšanim odmerkom, lahko nadaljujete zdravljenje z zdravilom TRISENOX z odmerkom 0,11 mg/kg telesne mase na dan še en teden.
After administration at 0.15 mg/kg on a daily (n=6) or twice-weekly (n=3) regimen, an approximate 2-fold accumulation of AsIII was observed as compared to a single infusion.
Po uporabi 0,15 mg/kg v dnevnem (n = 6) ali dvakrat-tedenskem (n = 3) režimu odmerjanja so opazili približno 2-kratno akumulacijo AsIII v primerjavi z enkratnim infundiranjem.
In the total single dose range of 7 to 32 mg (administered as 0.15 mg/kg), systemic exposure (AUC) appears to be linear.
V skupnem razponu enkratnega odmerka od 7 do 32 mg (aplicirano kot 0,15 mg/kg), kaže, da je sistemska izpostavljenost (AUC) linearna.
18-Month
18 mes
- Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with TRISENOX.
- Testiranje krvi (kalij, kalcij, magnezij in delovanje jeter) je treba med zdravljenjem z zdravilom TRISENOX ponoviti.
TRISENOX dose, mg/kg/day (median, range) Complete remission Time to bone marrow remission (median)
odmerek zdravila TRISENOX, mg/kg/dan (mediana, obseg) popolna remisija čas do remisije kostnega mozga (mediana)
The Kaplan-Meier median CR duration for the single institution study is 14 months and has not been reached for the multicentre study.
Mediana trajanja CR po metodi Kaplan-Meier v enocentrični študiji je 14 mesecev.
AsIII is the pharmacologically active species of arsenic trioxide.
AsIII je farmakološko aktivna komponenta arzenovega trioksida.
Patients in the first study received a median dose of 0.16 mg/kg/day of TRISENOX (range 0.06 to 0.20 mg/kg/day) and patients in the multicentre study received a fixed dose of 0.15 mg/kg/day.
Bolniki v prvi študiji so prejemali mediano odmerka 0,16 mg/kg zdravila TRISENOX 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.
Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland
Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Irska
Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli.
In particular tell your doctor - if you are taking any of various types of medicines which could cause a change in the rhythm of your heartbeat.
- če jemljete zdravila različnih vrst, ki bi lahko spremenila ritem srčnega utripa.
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).
Očistek AsIII v plazmi ni bil spremenjen pri bolnikih z blago okvaro delovanja ledvic (očistek kreatinina 50-80 ml/min) ali zmerno okvaro delovanja ledvic (očistek kreatinina 30-49 ml/min).
It is given as a drip (infusion) into a vein over 1-2 hours, but the infusion may last longer if side effects like flushing and dizziness occur.
Daje se v obliki kapalne infuzije v krvno žilo, pri čemer bo infuzija trajala 1-2 uri, lahko traja tudi dlje, če se pojavijo neželeni učinki, kot so vročinski oblivi ali omotica.
Arsenic trioxide has been shown to be embryotoxic and teratogenic in animal studies (see section 5.3).
Študije na živalih so dokazale, da je arzenov trioksid embriotoksičen in teratogen (glejte poglavje 5.3).
Dilution: Carefully insert the needle of a syringe into the vial and withdraw the required volume.
Redčenje: V vialo previdno vstavite iglo injekcijske brizge in odvzemite potrebno količino.
Previous treatment with anthracyclines may increase the risk of QT prolongation.
Predhodno zdravljenje z antraciklini lahko zveča nevarnost podaljšanja intervala Q-T.
Multicentre trial N=40
Multicentrična raziskava N = 40
Electrocardiogram (ECG) abnormalities
Anomalije elektrokardiograma (EKG)
After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15-30 °C and 72 hours at refrigerated (2-8 °C) temperatures.
Po redčenju v intravenskih raztopinah je zdravilo TRISENOX kemijsko in fizikalno stabilno 24 ur pri temperaturi med 15-30 °C in 72 ur pri nižjih temperaturah (2-8 °C).
Clearance is not dependent on the weight of the subject or the dose administered over the dose range studied.
Očistek ni odvisen od telesne mase osebe ali odmerka, danega v preučevanem razponu odmerka.
In case of reappearance of hepatotoxicity, TRISENOX must be permanently discontinued.
Če znova pride do hepatotoksičnosti, je treba trajno prenehati zdravljenje z zdravilom TRISENOX.
However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Vendar arzenov trioksid in druge anorganske arzenove spojine veljajo za snovi, ki so humani karcinogeni.
Psychiatric disorders Confusional state
Psihiatrične motnje stanje zmedenosti
TRISENOX is for single use only.
Zdravilo TRISENOX je samo za enkratno uporabo.
In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %.
Pri na novo diagnosticiranih bolnikih z APL z nizkim do srednjim tveganjem so opazili podaljšanje intervala Q-Tc pri 15,6 %.
As soon as bilirubin and/or SGOT and/or alkaline phosphatase are decreased to below 4 times the normal upper level, treatment with TRISENOX should be resumed at 50 % of the previous dose during the first 7 days.
Takoj ko se vrednosti bilirubina in/ali serumske aspartat-aminotransferaze (SGOT) in/ali alkalne fosfataze znižajo pod vrednost 4-kratnika zgornje meje normale, je treba zdravljenje z zdravilom TRISENOX nadaljevati s 50 % prejšnjega odmerka v prvih 7 dneh.
Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RAR conversion to normal are shown in table 5 below.
Citogenetska potrditev pretvorbe v normalen genotip in odkrivanje pretvorbe PML/RARα v običajno obliko z metodo polimerazne verižne reakcije z reverzno transkriptazo (RT-PCR - »reverse transcriptase - polymerase chain reaction«) je prikazana v tabeli 5 spodaj.
Total arsenic accumulates mainly in the liver, kidney, and heart and, to a lesser extent, in the lung, hair, and nails.
Skupno se arzen nalaga pretežno v jetrih, ledvicah in v srcu, v manjšem obsegu pa v pljučih,
Each pack contains 10 ampoules.
Eno pakiranje vsebuje 10 ampul.
What you need to know before you are given TRISENOX
Kaj morate vedeti, preden boste dobili zdravilo TRISENOX
Additional information about QT prolonging medicinal agents, is provided in section 4.4.
Dodatne informacije o učinkovinah, ki podaljšujejo interval Q-T, so v poglavju 4.4.
TRISENOX is used in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL), and in adult patients, whose disease has not responded to other therapies.
Zdravilo TRISENOX se uporablja pri odraslih bolnikih z na novo diagnosticirano akutno promielocitno levkemijo (APL) z nizkim do srednjim tveganjem in pri odraslih bolnikih, pri katerih druge oblike zdravljenja niso pomagale.
She went onto consolidation without further evidence of QT prolongation.
Konsolidacijsko zdravljenje je začela brez nadaljnjih znakov podaljšanja intervala Q-T.
For patients who cannot take oral medicinal product, dimercaprol administered at a dose of 3 mg/kg intramuscularly every 4 hours until any immediately life-threatening toxicity has subsided may be considered.
Pri pacientih, ki zdravil ne morejo jemati peroralno, se lahko uporabi dimerkaprol v odmerku 3 mg/kg intramuskularno vsake 4 ure do upada življenjsko nevarne toksičnosti.
2-Year event-free survival (EFS)
2-letno preživetje brez dogodka (EFS)
Single centre pilot trial N with CR = 11
Enocentrična pilotna študija N s CR = 11
59 days
59 dni
If symptoms suggestive of serious acute arsenic toxicity (e.g. convulsions, muscle weakness and confusion) appear, TRISENOX must be immediately discontinued and chelating therapy with penicillamine at a daily dose ≤ 1 g per day may be considered.
Če se pojavijo simptomi, značilni za resno akutno zastrupitev z arzenom (npr. krči, mišična slabotnost in zmedenost), morate zdravljenje z zdravilom TRISENOX nemudoma prekiniti in pretehtati kelacijsko zdravljenje z dnevnim odmerkom penicilamina (≤ 1 gram na dan).
If your disease responds to TRISENOX, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
Če se bolezen odzove na zdravilo TRISENOX, boste opravili drugi cikel zdravljenja, v katerem boste prejeli 25 odmerkov, ki jih boste dobivali 5 dni v tednu (ki jim sledi 2-dnevna prekinitev) 5 tednov.
Patients with risk factors of QTc prolongation or risk factors of torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Bolnikom, ki imajo visoke dejavnike tveganja za podaljšanje intervala Q-Tc ali za aritmijo torsade de pointes, morate nenehno nadzorovati srčno funkcijo (EKG).
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
Arzenov trioksid lahko povzroči podaljšanje intervala Q-T in popoln atrioventrikularni blok.
There are no data on the effect of arsenic trioxide on the QTc interval during the infusion.
Podatkov o učinku arzenovega trioksida na interval Q-Tc med infundiranjem ni.
Not evaluable RT-PCR for PML/ RAR
RT-PCR za PML/ RARα negativna pozitivna ni mogoče vrednotiti
Opening the ampoule: Hold the ampoule of TRISENOX with the coloured point upwards and in front of you.
Odpiranje ampule: Ampulo z zdravilom TRISENOX držite pred seboj z obarvano točko navzgor.
The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Učinkovina zdravila TRISENOX, arzenov trioksid, je humani kancerogen.