natgillin/translations-raw huggingface dataset:
Uncommon (affects less than 1 in 100 patients) In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Trevaclyn. • swelling of the face, lips, tongue, and/ or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away) • fainting • shortness of breath • loss of control over urine and stool • cold sweats • shivering • chills • increased blood pressure • swelling of the lips • burning sensation • whole body rash • joint pain • swelling of the legs • rapid heart rate.
Občasni (pojavijo se pri manj kot 1 od 100 bolnikov) Kot del alergijske reakcije na zdravilo Trevaclyn so poročali še o enem ali večih od naslednjih simptomov: • oteklost obraza, ustnic, jezika in/ ali žrela, ki lahko povzroči težave z dihanjem in požiranjem (angioedem, ki lahko zahteva takojšnje zdravljenje) • omedlevica • težko dihanje • izguba nadzora nad zadrževanjem urina in blata • hladno znojenje • drgetanje • mrzlica • zvišan krvni tlak • otekanje ustnic • pekoč občutek • izpuščaj po celem telesu • bolečine v sklepih • otekanje nog • hitro bitje srca.
HOW TO STORE TREVACLYN
SHRANJEVANJE ZDRAVILA TREVACLYN
Do not use Trevaclyn after the expiry date (EXP) which is stated on the carton and the blister.
Zdravila Trevaclyn ne smete uporabljati po datumu izteka roka uporabnosti (Uporabno do:), ki je naveden na škatli in pretisnem omotu.
What Trevaclyn contains • The active substances are nicotinic acid and laropiprant.
Kaj vsebuje zdravilo Trevaclyn • Zdravilni učinkovini sta nikotinska kislina in laropiprant.
What Trevaclyn looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Izgled zdravila Trevaclyn in vsebina pakiranja Tablete s prirejenim sproščanjem so v obliki kapsul, bele do kremaste barve in imajo na eni strani vtisnjeno oznako "552".
Aluminium/ Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Aluminijsko/ aluminijski pretisni omot s prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
What is TRISENOX?
Kaj je zdravilo TRISENOX?
TRISENOX is a concentrate for solution for infusion containing the active substance arsenic trioxide (1 mg/ ml).
Zdravilo TRISENOX je koncentrat za raztopino za infundiranje, ki vsebuje zdravilno učinkovino arzenov trioksid (1 mg/ ml).
What is TRISENOX used for?
Za kaj se zdravilo TRISENOX uporablja?
TRISENOX is used to treat adult patients with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells).
Zdravilo TRISENOX se uporablja za zdravljenje odraslih bolnikov z akutno promielocitno levkemijo (APL), redko obliko levkemije (raka belih krvnih celic).
APL is caused by a genetic ‘ translocation’ (when there is a swap of genes between two chromosomes).
APL povzroča genetska „ translokacija “ (zamenjava genov med dvema kromosomoma).
The translocation affects the way the white blood cells grow, and they lack the ability to use retinoic acid (vitamin A).
Translokacija prizadane rast belih krvnih telesc, ki jim primanjkuje sposobnost izrabljanja retinojske kisline (vitamin A).
Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Bolnike z APL se navadno zdravi z retinoidi (snovmi, pridobljenimi iz vitamina A).
TRISENOX is used when patients have not responded to treatment with retinoids and anticancer medicines, or when their disease has come back after this type of treatment.
TRISENOX se uporablja, kadar se bolniki niso odzvali na zdravljenje z retinoidi ali z zdravili proti raku ali kadar se je bolezen vrnila po taki vrsti zdravljenja.
How is TRISENOX used?
Kako se zdravilo TRISENOX uporablja?
TRISENOX treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Zdravljenje z zdravilom TRISENOX mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutno levkemijo.
TRISENOX is given daily until there are signs that the treatment is working (the bone marrow does not contain any leukaemia cells).
Zdravilo TRISENOX se daje dnevno, dokler ni znakov, da zdravljenje deluje (ko kostni mozeg ne vsebuje več levkemičnih celic).
If this does not happen by day 50, dosing should be stopped.
Če se to ne zgodi do 50. dneva, je treba prenehati z odmerjanjem.
The first treatment is then consolidated, three to four weeks later, by giving TRISENOX once daily for five days, followed by a two-day break, repeated for five weeks.
Prvo zdravljenje je nato konsolidirano tri do štiri tedne kasneje tako, da se zdravilo TRISENOX daje pet dni zaporedoma enkrat dnevno, temu sledi dvodnevni premor, ponavljamo pet tednov.
TRISENOX is given as an infusion (drip into a vein) over one to two hours, but this may be increased to four hours if there are infusion reactions.
Ta čas pa se lahko podaljša na štiri ure, če se pojavijo reakcije na infundiranje.
The dose is 0.15 mg per kilogram body weight for all types of patients (children, adults and elderly patients).
Odmerek znaša 0, 15 mg na kilogram telesne mase za vse bolnike (otroke, odrasle in starejše bolnike).
How does TRISENOX work?
Kako zdravilo TRISENOX deluje?
The active substance in TRISENOX, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Zdravilna učinkovina v zdravilu TRISENOX, arzenov trioksid, je kemikalija, ki se v zdravilih uporablja že mnogo let, vključno pri zdravljenju levkemije.
It is thought to prevent the DNA production necessary for leukaemia cell growth.
Predvideva se, da preprečuje proizvodnjo DNA, potrebno za rast levkemičnih celic.
How has TRISENOX been studied?
Kako je bilo zdravilo TRISENOX raziskano?
TRISENOX has been examined in two studies involving 52 patients with APL who had been previously treated with anthracyline (a type of anticancer medicine) and a retinoid.
Zdravilo TRISENOX je bilo raziskano v dveh študijah, v katerih je sodelovalo 52 bolnikov z APL, ki so bili predhodno zdravljeni z antracilinom (vrsta zdravila proti raku) in retinoidom.
The first study 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zdravilo TRISENOX ni bilo v nobeni od študij primerjano 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
TRISENOX was not compared with any other medicine in either study.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged z drugim zdravilom.
The main measure of effectiveness was the proportion of patients who had complete remission, with no leukaemia cells in the bone marrow and recovery of the levels of platelets and white blood cells in the blood.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so imeli popolno remisijo bolezni, brez levkemičnih celic v kostnem mozgu in obnovitev krvnih ploščic in belih krvnih celic v krvi.
What benefit has TRISENOX shown during the studies?
Kakšne koristi je zdravilo TRISENOX izkazalo med raziskavami?
Looking at the results of the two studies together, 45 (87%) of the 52 patients had complete remission.
Pri pregledu rezultatov obeh študij skupaj je imelo popolno remisijo 45 (87%) od 52 bolnikov.
What is the risk associated with TRISENOX?
Kakšna tveganja so povezana z zdravilom TRISENOX?
The most commonly reported side effects with TRISENOX (seen in between 1 and 10 patients in 100) are neutropenia (low levels of white blood cells), thrombocytopenia (low levels of platelets), hyperglycaemia (raised blood sugar levels), hypokalaemia (low blood potassium levels), paraesthesia (pins and needles), pleuritic pain (chest pain), dyspnoea (breathlessness), bone pain, arthralgia (joint pain), pyrexia (fever), fatigue (tiredness), prolonged QT interval on an electrocardiogram (irregular heart beat), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Najpogostejši neželeni učinki pri zdravilu TRISENOX (opaženi pri od 1 do 10 bolnikih od 100) so nevtropenija (nizke ravni belih krvnih celic), trombocitopenija (nizke ravni krvnih ploščic), hiperglikemija (povečane ravni sladkorja v krvi), hipokalemija (nizke ravni kalija v krvi), parestezija (zbadanje), plevritične bolečine (bolečine v prsnem košu), dispneja (zasoplost), bolečine v kosteh, artralgija (bolečine v sklepih), pireksija (povišana telesna temperature), utrujenost, podaljšan interval QT na elektrokardiogramu (nereden srčni utrip) ter povečane ravni alanin aminotrasferaze in aspartat aminotransferaze (jetrna encima).
For the full list of all side effects reported with TRISENOX, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TRISENOX, glejte Navodilo za uporabo.
TRISENOX should not be used in people who may be hypersensitive (allergic) to arsenic trioxide or any of the other ingredients.
Zdravila TRISENOX ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) arzenov trioksid ali katerokoli drugo sestavino zdravila.
Because arsenic trioxide can affect the heart, patients receiving TRISENOX should be closely monitored, and should have electrocardiograms before and during treatment.
Arzenov trioksid lahko vpliva na srce, zato je treba bolnike, ki prejemajo TRISENOX natančno spremljati ter opraviti elektrokardiogram pred in med zdravljenjem.
Why has TRISENOX been approved?
Zakaj je bilo zdravilo TRISENOX odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that TRISENOX’ s benefits are greater than its risks for induction of remission and consolidation in adult patients with relapsed/ refractory APL, characterised by the presence of the t(15; 17) translocation and/ or the presence of the Pro-Myelocytic Leukaemia/ Retinoic-Acid-Receptor-alpha (PML/ RAR-alpha) gene, when previous treatment has included a retinoid and chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila TRISENOX za indukcijo remisije in konsolidacijo pri odraslih bolnikih z akutno promielocitno levkemijo (APL) pri relapsu ali v refraktarnem obdobju, za katero je značilna prisotnost translokacije t( 15; 17) in/ ali prisotnost gena za receptor za promielocitno levkemijo/ retinojsko kislino alfa (PML/ RAR- alfa) in pri katerih je predhodno zdravljenje vključevalo retinoid in kemoterapijo, večje od z njim povezanih tveganj.
The Committee recommended that TRISENOX be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom TRISENOX.
TRISENOX has been authorised under “ Exceptional Circumstances”.
Zdravilo TRISENOX je bilo odobreno „ v izjemnih okoliščinah “.
This means that because the disease is rare, it has not been possible to obtain complete information about TRISENOX.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu TRISENOX.
What information is still awaited for TRISENOX?
Katere informacije o zdravilu TRISENOX še pričakujemo?
The company that makes TRISENOX will complete its studies into the use of TRISENOX in patients with liver cancer and its use with retinoids and chemotherapy in APL.
Podjetje, ki izdeluje zdravilo TRISENOX, bo dokončalo svoje študije o uporabi zdravila TRISENOX pri bolnikih z rakom na jetrih in o njegovi uporabi z retinoidi in kempoterapijo pri APL.
Other information about TRISENOX:
Druge informacije o zdravilu TRISENOX:
The European Commission granted a marketing authorisation valid throughout the European Union, for TRISENOX on 5 March 2002.
Evropska komisija je dovoljenje za promet z zdravilom TRISENOX, veljavno po celotni Evropski uniji, podelila dne 5. marca 2002.
The marketing authorisation was renewed on 5 March 2007.
Dovoljenje je bilo podaljšano 5. marca 2007.
The marketing authorisation holder is Cephalon Europe.
Imetnik dovoljenja za promet z zdravilom je družba Cephalon Europe.
The full EPAR for TRISENOX is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo TRISENOX je na voljo tukaj.
1mg/ ml
ampul po 10 ml (1mg/ ml).
Intravenous use
Intravenska uporaba Ampula
TRISENOX 1 mg/ ml, concentrate for solution for infusion
TRISENOX 1 mg/ ml, koncentrat za raztopino za infundiranje
One ml of TRISENOX contains 1 mg of Arsenic trioxide
En ml zdravila TRISENOX vsebuje 1 mg arzenovega trioksida.
Concentrate for solution for infusion Sterile, clear, colourless, aqueous solution.
Sterilna, bistra, brezbarvna vodna raztopina.
TRISENOX is indicated for induction of remission and consolidation in adult patients with relapsed/ refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15; 17) translocation and/ or the presence of the Pro-Myelocytic Leukaemia/ Retinoic-Acid-Receptor- alpha (PML/ RAR-alpha) gene.
Zdravilo TRISENOX je indicirano za indukcijo remisije in konsolidacije pri odraslih bolnikih z akutno promielocitno levkemijo (APL – » acute promyelocytic leukaemia «) v relapsu ali refraktarni fazi, za katero je značilna prisotnost translokacije t( 15; 17) in/ ali prisotnost gena za receptor za promielocitno levkemijo/ retinojsko kislino alfa (PML/ RAR- alfa).
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.
The same dose is recommended for children, adults, and elderly.
Isti odmerek se priporoča za otroke, odrasle in starejše bolnike.
TRISENOX must be administered intravenously at a fixed dose of 0.15 mg/ kg/ day given daily until the bone marrow remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence of leukaemic cells).
Program indukcijskega zdravljenja z zdravilom TRISENOX mora biti uporabljen intravensko v stalnem odmerku 0, 15 mg/ kg/ dan, dokler ni dosežena remisija kostnega mozga (prisotnih manj kot 5% blastov v celičnem kostnem mozgu in brez sledi levkemičnih celic).
Consolidation schedule:
Program konsolidacije:
Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy.
Konsolidacijsko zdravljenje se mora začeti 3– 4 tedne po koncu indukcijskega zdravljenja.
TRISENOX is to be administered intravenously at a dose of 0.15 mg/ kg/ day for 25 doses given 5 days per week, followed by 2 days interruption, repeated for 5 weeks.
25 odmerkov morate dajati 5 tednov po 5 dni na teden z 2 dnevno prekinitvijo.
The experience in children is limited.
Pediatrična uporaba: izkušnje z otroci so omejene.
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.
Od sedem bolnikov, starih pod 18 let (od 5 do 16 let), ki so bili zdravljeni z zdravilom TRISENOX pri priporočenem odmerku 0, 15 mg/ kg/ dan, se je pet bolnikov na zdravljenje odzvalo v celoti.
Safety and effectiveness in paediatric patients under 5 years of age have not been studied.
Varnost in učinkovitost pri bolnikih, mlajših od pet let, ni raziskana.
Patients with hepatic and/ or renal impairment:
Bolniki z jetrno in/ ali ledvično okvaro:
Since limited data are available across all hepatic impairment groups and across all renal impairment groups, caution is advised in the use of TRISENOX in patients with hepatic and/ or renal impairment.
Ker so na voljo omejeni podatki za vse skupine bolnikov z jetrno okvaro in za vse skupine bolnikov z ledvično okvaro, se pri uporabi zdravila TRISENOX priporoča previdnost pri bolnikih z jetrno in/ ali ledvično okvaro.
Method of administration 2 TRISENOX must be administered intravenously over 1-2 hours.
2 Način uporabe
Leukocyte Activation Syndrome (APL Differentiation Syndrome):
Sindrom aktivacije levkocitov (sindrom diferenciacije APL):
Twenty-five percent of patients with APL treated with TRISENOX 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.
Pri 25% bolnikov z APL, ki so jih zdravili z zdravilom TRISENOX, so se pojavili simptomi, podobni sindromu, imenovanemu retinojska kislina – akutna promielocitna levkemija (RA- APL) ali sindrom diferenciacije APL, za katerega so značilni povišana telesna temperatura, dispneja, pridobivanje telesne mase, pljučni infiltrati in plevralni ali perikardialni izlivi, z levkocitozo ali brez nje.
The management of the syndrome has not been fully studied, but high-dose steroids have been used at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms.
Videti je, da so s tem ublažili bolezenske znake in simptome.
At the first signs that could suggest the syndrome (unexplained fever, dyspnoea and/ or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), 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.
Ob prvih znakih, ki bi kazali na ta sindrom (nepojasnjena povišana telesna temperatura, dispneja in/ ali pridobivanje telesne mase, nenormalni avskultatorni izvidi ali radiografske anomalije prsnega koša), morate takoj začeti dajati visoke odmerke steroidov (deksametazon 10 mg intravensko dvakrat na dan) in z njimi nadaljevati vsaj 3 dni ali dlje, dokler bolezenski znaki ne izginejo, ne glede na število levkocitov.
Electrocardiogram (ECG) Abnormalities:
Anomalije elektrokardiograma (EKG):
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
Arzenov trioksid lahko povzroči podaljšanje intervala Q- T in popoln atrioventrikularni blok.
QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal.
Podaljšanje intervala Q- T lahko povzroči smrtno nevarno ventrikularno aritmijo vrste torsade de pointes.
Previous treatment with anthracyclines may increase the risk of QT prolongation.
Predhodno zdravljenje z antraciklini lahko poveča nevarnost podaljšanja intervala Q- T.
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 drugs 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 hypokalemia or hypomagnesaemia.
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.
In clinical trials, 40% of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec.
V kliničnih preskušanjih je pri 40% bolnikov, ki so jih zdravili z zdravilom TRISENOX, prišlo do vsaj enega podaljšanja popravljenega intervala Q- T (Q- Tc), ki je trajal več kot 500 ms.
Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Podaljšanje intervala Q- Tc se je pojavilo v 1 do 5 tednih po infundiranju zdravila TRISENOX in se je do konca 8. tedna po infundiranju zdravila TRISENOX vrnilo na osnovno vrednost.
ECG and Electrolyte Monitoring Recommendations:
Priporočila za nadzor EKG in elektrolitov:
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; 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 zdravilom TRISENOX morate opraviti 12- kanalni EKG in preglede ravni serumskih elektrolitov (kalija, kalcija in magnezija) ter
3 and the QTc reassessed with serial ECGs prior to considering using TRISENOX.
Odpraviti je treba tudi obstoječe anomalije elektrolitov in, če je mogoče, prenehati dajati zdravila, za katera je znano, da podaljšajo interval Q- T.
During therapy with TRISENOX, potassium concentrations must be kept above 4 mEq/ l and magnesium concentrations must be kept above 1.8 mg/ dl.
Med zdravljenjem z zdravilom TRISENOX morate vzdrževati koncentracijo kalija nad 4 mEq/ l in koncentracijo magnezija nad 1, 8 mg/ dl.
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 TRISENOX therapy must be considered.
Ob tem morate oceniti razmerje korist/ tveganje nadaljevanja zdravljenja z zdravilom TRISENOX.
If syncope, rapid or irregular heartbeat develops, the patient must be hospitalised and monitored continuously, serum electrolytes must be assessed, TRISENOX therapy must be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
Če se pojavi sinkopa, pospešen ali nepravilen srčni utrip, morate bolnika sprejeti v bolnišnico in ga nenehno nadzorovati, pregledati morate ravni elektrolitov v serumu, začasno morate prekiniti zdravljenje z zdravilom TRISENOX, dokler se trajanje intervala Q- Tc ne vrne pod 460 ms, se anomalije ravni elektrolitov ne popravijo in sinkopa in nepravilen srčni utrip ne prenehata.
There are no data on the effect of TRISENOX on the QTc interval during the infusion.
Podatkov o učinku zdravila TRISENOX na interval Q- Tc med infundiranjem ni.
Dose Modification:
Spreminjanje odmerka:
Treatment with TRISENOX must be interrupted, adjusted, or discontinued before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria, Version 2 is observed and judged to be possibly related to TRISENOX treatment.
Zdravljenje z zdravilom TRISENOX morate pred načrtovanim koncem terapije prekiniti, prilagoditi ali prenehati v katerem koli trenutku, ko opazite toksičnost 3. stopnje po 2. različici splošnih meril toksičnosti Narodnega instituta za rak in ocenite, da je morda povezana z zdravljenjem z zdravilom TRISENOX.
In such cases, treatment must resume at 50% of the preceding daily dose.
V takih primerih zdravljenje lahko nadaljujete s 50% prejšnjega dnevnega odmerka.
If the toxic event does not recur within 3 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose.
Če v treh dneh po ponovnem začetku zdravljenja s polovičnim odmerkom ne pride do toksičnosti, lahko dnevni odmerek zvišate spet na 100% začetnega odmerka.