natgillin/translations-raw huggingface dataset:
Related adverse reactions of CTC grade 3 and 4 occurred in 37 % of relapsed/refractory APL patients in clinical trials.
Sažetak sigurnosnog profila Povezane nuspojave CTC stupnja 3 ili 4 pojavile su se u 37% ispitanika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje u kliničkim ispitivanjima.
Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co. Louth,
Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk, Co.
Patients who are receiving, or who have received, medicinal products known to cause hypokalaemia or hypomagnesaemia, such as diuretics or amphotericin B,
Bolesnici koji primaju, ili koji su primali, lijekove za koje se zna da uzrokuju hipokalemiju ili hipomagnezijemiju, poput diuretika ili amfotericina B, mogu biti pod većim rizikom od torsade de pointes.
Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kutiji.
18-Month survival
59 dana preživljenje od 18 mjeseci
Time to CR (median)
Vrijeme do potpune remisije (medijan)
Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 ml/min) or moderate renal impairment (creatinine clearance of 30-49 ml/min).
Oštećenje bubrega Plazmatski klirens AsIII nije bio izmijenjen u bolesnika s blagim oštećenjem bubrega (klirens kreatinina od 50 do 80 ml/min) ili umjerenim oštećenjem bubrega (klirens kreatinina od 30 do
Leucocytosis occurred in 50 % of patients with relapsed/refractory APL, as determined by haematology assessments.
Leukocitoza se pojavila u 50% bolesnika s APL-om koji je bio u fazi relapsa/refraktoran na liječenje, kako je to utvrđeno hematološkim pretragama.
TRISENOX contains sodium
TRISENOX sadrži natrij
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.
QT intervala, anamnezom ili prisutnošću značajnih ventrikularnih ili atrijskih tahiaritmija, klinički značajnom bradikardijom u mirovanju (< 50 otkucaja srca u minuti), QTc > 450 ms na probirnom EKG-u, blokom desne grane i prednjim lijevim hemiblokom, bifascikularnim blokom) ili neuropatijom.
In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with TRISENOX in combination with ATRA compared to patients treated with ATRA + chemotherapy.
U novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika pojavili su se gastrointestinalna toksičnost, neutropenija 3.- 4. stupnja i trombocitopenija 3. ili 4. stupnja, međutim ti su učinci bili 2,2 puta manje česti u bolesnika liječenih TRISENOXOM u kombinaciji s ATRA-om u usporedbi s bolesnicima liječenima kombinacijom ATRA + kemoterapija (vidjeti tablicu 2).
Patients in the ATRA + chemotherapy treatment group also received maintenance treatment for up to 2 years, consisting of oral 6-mercaptopurine at 50 mg/m2 daily, intramuscular methotrexate at 15 mg/m2 weekly, and ATRA at 45 mg/m2 daily for 15 days every
Bolesnici u skupini liječenoj kombinacijom ATRA+kemoterapija također su primali liječenje održavanja tijekom 2 godine koje se sastojalo od peroralno primijenjenog 6-merkaptopurina u dozi od 50 mg/m2 dnevno, metotreksata u dozi od 15 mg/m2 tjedno primijenjenog intramuskularno i ATRA-e u dozi od 45 mg/m2 dnevno tijekom
TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the ampoule or vial.
TRISENOX se mora razrijediti pomoću 100 do 250 ml otopine glukoze za injekciju 50 mg/ml (5%) ili otopine natrijeva klorida 9 mg/ml (0,9%) za injekciju odmah nakon izvlačenja lijeka iz ampule ili bočice.
Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Bolesnici u multicentričnom ispitivanju doživjeli su relaps nakon 1 do 4 terapije prije liječenja, a 5 bolesnika doživjelo je relaps nakon transplantacije matičnim stanicama.
Hyperleucocytosis
Hiperleukocitoza
Thereafter, in absence of worsening of the previous toxicity, TRISENOX should be resumed at full dosage.
Nakon toga, u odsutnosti pogoršanja prethodne toksičnosti, potrebno je nastaviti liječenje TRISENOXOM u punoj dozi.
TRISENOX 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 TRISENOX combined with all-trans-retinoic acid (ATRA) with those of ATRA + chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Bolesnici s novodijagnosticiranim APL-om koji nije visokog rizika TRISENOX je ispitan u 77 novodijagnosticiranih bolesnika s APL-om niskog do srednjeg rizika u kontroliranom, randomiziranom, kliničkom ispitivanju neinferiornosti faze 3 koje je uspoređivalo djelotvornost i sigurnost liječenja TRISENOXOM u kombinaciji sa sve-trans-retinoatnom kiselinom (ATRA) u odnosu na kombinirano liječenje ATRA+kemoterapija (npr. idarubicin i mitoksantron) (Ispitivanje APL0406).
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).
Lijekovi za koje je poznato da imaju hepatotoksične učinke Tijekom liječenja arsenovim trioksidom mogu se pojaviti hepatotoksični učinci; potreban je oprez kada se TRISENOX istodobno primjenjuje s drugim lijekovima za koje je poznato da imaju hepatotoksične učinke (vidjeti dijelove 4.4 i 4.8).
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.
TRISENOX je ispitivan u 52 bolesnika s APL-om, koji su prethodno bili liječeni antraciklinom i retinoidima u dva otvorena, neusporedna ispitivanja s pojedinačnim skupinama.
Infections and infestations Herpes zoster
Infekcije i infestacije
Dose delay and modification
Odgoda i prilagodba doze
Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule.
Protresite ampulu ili kucnite po njoj prstima kako bi se tekućina koncentrirala u tijelu ampule.
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.
TRISENOX se primjenjuje intravenski pri dozi od 0,15 mg/kg/dan po 25 doza koje se daju 5 dana u tjednu, nakon čega slijedi 2 dana pauze, a cijeli se ciklus ponavlja tijekom 5 tjedana.
However, toxic effects resolved with temporary discontinuation of either arsenic trioxide, ATRA or both.
Međutim, toksični učinci povukli su se pri privremenom prekidu liječenja arsenovim trioksidom, lijekom ATRA ili obama lijekovima.
• some medicines to treat allergies such as hay fever, called antihistamines (e.g. terfenadine and astemizole)
• neke vrste lijekova za liječenje bakterijskih infekcija (primjerice, eritromicin i sparfloksacin) • neke lijekove za liječenje alergija poput peludne groznice, zvani antihistaminici (primjerice terfenadin i astemizol)
It must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
Ne smije se miješati ili davati istodobno s drugim lijekovima kroz istu intravensku liniju.
TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved.
TRISENOX se mora primjenjivati intravenski pri dozi od 0,15 mg/kg/dan, svaki dan, sve dok se ne postigne potpuna remisija.
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.
Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekovakoji produljuju QT interval , anamnezom torsade de pointes, postojećim prethodnim produljenjem QT intervala, kongestivnim zatajenjem srca, primjenom diuretika koji troše kalij ili druga stanja koja rezultiraju hipokalemijom ili hipomagnezijemijom.
Patients in the single centre study had relapsed following 1-6 prior therapy regimens and 2 patients had relapsed following stem cell transplantation.
Bolesnici u monocentričnom ispitivanju doživjeli su relaps nakon 1 do 6 terapija prije liječenja, a 2 su bolesnika doživjela relaps nakon transplantacije matičnim stanicama.
Cardiac disorders Tachycardia
Srčani poremećaji tahikardija
In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
U jednog novodijagnosticiranog bolesnika indukcijsko je liječenje bilo prekinuto zbog jako produljenog Qtc intervala i poremećaja elektrolita 3. dana indukcijskog liječenja.
All parenteral solutions must be inspected visually for particulate matter and discoloration prior to administration.
Sve parenteralne otopine treba prije primjene vizualno pregledati na strane čestice i promjenu boje.
There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Nije se činilo da postoji veza između početnih vrijednosti leukocita i razvoja leukocitoza niti se pojavila korelacija između početnih i vršnih vrijednosti leukocita.
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.
Među novodijagnosticiranim bolesnicima s APL-om niskog do srednjeg rizika, njih 63,2% razvilo je hepatotoksične učinke 3. ili 4. stupnja tijekom indukcijskog ili konsolidacijskog liječenja TRISENOXOM u kombinaciji s ATRA-om.
Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with TRISENOX, caution is advised in the use of TRISENOX in patients with hepatic impairment (see section 4.4 and 4.8).
S obzirom da ni za jednu skupinu s oštećenjem jetre nema dostupnih podataka, a hepatotoksični učinci se mogu pojaviti tijekom liječenja TRISENOXOM, potreban je oprez kod primjene TRISENOXA u bolesnika s oštećenjem jetre (vidjeti dio 4.4 i 4.8).
Fertility No clinical or non-clinical fertility studies have been conducted with TRISENOX.
Nisu provedena klinička ili neklinička ispitivanja utjecaja TRISENOXA na plodnost.
Unused portions of each vial must be discarded properly.
Neiskorišteni dio svake bočice mora se odložiti na ispravan način.
Musculoskeletal and connective tissue disorders Myalgia
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija
ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF TRISENOX SINCE NO PRESERVATIVE IS PRESENT.
POTREBNO JE PRIDRŽAVATI SE STROGIH ZAHTJEVA ASEPTIČKE TEHNIKE TIJEKOM RUKOVANJA TRISENOXOM S OBZIROM DA LIJEK NE SADRŽI KONZERVANS.
Arsenic is excreted in human milk.
Arsen se izlučuje u majčino mlijeko.
- If you have further questions, please ask your doctor, pharmacist or nurse.
- Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
Jedna ampula od 10 ml sadrži 10 mg arsenovog trioksida.
There are no studies in pregnant women using TRISENOX.
Ispitivanja na trudnicama koje su uzimale TRISENOX nisu provedena.
TRISENOX must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products.
TRISENOX se ne smije miješati ili davati istodobno s drugim lijekovima kroz istu intravensku liniju.
Since no data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
S obzirom da ni za jednu skupinu s oštećenjem bubrega nema dostupnih podataka, potreban je oprez kod primjene TRISENOXA u bolesnika s oštećenjem bubrega.
In one patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3.
U jednog bolesnika indukcijsko je liječenje bilo prekinuto zbog jako produljenog QTc intervala i poremećaja elektrolita 3. dana.
Hydrochloric acid (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari natrijev hidroksid kloridna kiselina (za podešavanje pH) voda za injekcije
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.
Enzimatska in vitro ispitivanja na humanim jetrenim mikrosomima otkrila su da arsenov trioksid ne posjeduje inhibitornu aktivnost spram supstrata najvažnijih enzima citokroma P450 poput 1A2, 2A6,
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) Induction treatment schedule
Novodijagnosticirana akutna promijelocitna leukemija (APL) niskog do srednjeg rizika
TRISENOX at 0.15 mg/kg daily until CR. 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 TRISENOX was given at the same dose 5 days per week, 4 weeks on and 4 weeks off, for a total of 4 courses.
Tijekom konsolidacije, ATRA se davala u istoj dozi tijekom razdoblja od 2 tjedna nakon čega su slijedila 2 tjedna pauze, u ukupno 7 ciklusa, a TRISENOX se davao u istoj dozi 5 dana u tjednu tijekom 4 tjedna, nakon čega su slijedila 4 tjedna pauze, u ukupno 4 ciklusa.
IV use after dilution
Intravenski nakon razrjeđivanja
*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.
*U ispitivanju CALGB C9710, 2 slučaja stupnja ≥ 3 povećane GGT prijavljena su između 200
Excipients: sodium hydroxide, hydrochloric acid, water for injections
POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev hidroksid, kloridna kiselina, voda za injekcije
Single centre pilot trial N with CR = 11
Monocentrično pilot ispitivanje Bolesnici s potpunom remisijom = 11
General disorders and administration site conditions Pyrexia
Opći poremećaji i reakcije na mjestu primjene pireksija
Fertility studies have not been conducted with TRISENOX.
S TRISENOXOM nisu provedena ispitivanja plodnosti.
Marketing Authorisation Holder Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Teva B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
If you have any further question on the use of this medicine, ask your doctor, pharmacist or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
TRISENOX 1 mg/ml concentrate for solution for infusion 4 years.
TRISENOX 1 mg/ml koncentrat za otopinu za infuziju 4 godine.
TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 2 mg/ml concentrate for solution for infusion
TRISENOX 1 mg/ml koncentrat za otopinu za infuziju TRISENOX 2 mg/ml koncentrat za otopinu za infuziju
Blood and lymphatic system disorders Febrile neutropenia
Poremećaji krvi i limfnog sustava febrilna neutropenija leukocitoza neutropenija pancitopenija trombocitopenija anemija leukopenija limfopenija
The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Dnevna doza može se ponovno povisiti na 100%
Each carton contains 10 single-use glass ampoules.
Jedna kutija sadrži 10 staklenih ampula za jednokratnu primjenu.
How to store TRISENOX
Kako čuvati TRISENOX
Each carton contains 10 single-use glass vials.
Jedna kutija sadrži 10 staklenih bočica za jednokratnu primjenu.
Preparation of TRISENOX
Priprema TRISENOXA
Each vial of 6 ml contains 12 mg of arsenic trioxide.
Jedna bočica od 6 ml sadrži 12 mg arsenovog trioksida.
Present
Prisutno
In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. 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.
U kliničkim ispitivanjima bolesti u fazi relapsa/refraktorne na liječenje, 40% bolesnika liječenih TRISENOXOM iskusilo je najmanje jedan korigirani produžetak QT (QTc) intervala veći od 500 ms.
Cardiac failure
Oštećenje bubrega
Use of TRISENOX
Uporaba TRISENOXA
TRISENOX 2 mg/ml concentrate for solution for infusion Each ml of concentrate contains 2 mg of arsenic trioxide.
TRISENOX 2 mg/ml koncentrat za otopinu za infuziju Jedan ml koncentrata sadrži 2 mg arsenovog trioksida.
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.
Te ozbiljne nuspojave pripisane arsenovom trioksidu uključivale su sindrom diferencijacije APL-a (3), leukocitozu (3), produljeni QT interval (4, 1 s torsade de pointes),
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.
U 27% bolesnika s APL-om koji je u fazi relapsa/refraktoran na liječenje i koji su liječeni arsenovim trioksidom pojavili su se simptomi slični sindromu zvanom sindrom retinoatne kiseline u akutnoj promijelocitnoj leukemiji (RA-APL) ili sindrom diferencijacije APL-a, koji karakteriziraju vrućica,
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
Tijekom konsolidacije bolesnici su primali idarubicin u dozi od 5 mg/m2 tijekom 1.- 4. dana i ATRA-u u dozi od 45 mg/m2 dnevno tijekom 15 dana, potom u venu mitoksantron u dozi od 10 mg/m2 tijekom 1.5. dana i ATRA-u ponovno u dozi od 45 mg/m2 dnevno tijekom 15 dana i konačno jednu dozu idarubicina od 12 mg/m2 i ATRA-e od 45 mg/m2 dnevno tijekom 15 dana.
Because of the potential for serious adverse reactions in breast-feeding infants and children from TRISENOX, breast-feeding must be discontinued prior to and throughout administration.
Prije i tijekom primjene TRISENOXA mora se prekinuti dojenje zbog mogućnosti nastanka ozbiljnih nuspojava u dojenčadi i djece.
Encephalopathy, Wernicke encephalopathy
Vrlo često konvulzija encefalopatija, Wernickeova encefalopatija
Each ml of concentrate contains 1 mg of arsenic trioxide.
Jedan ml koncentrata sadrži 1 mg arsenovog trioksida.
The infusion duration may be extended up to 4 hours if vasomotor reactions are observed.
Trajanje infuzije može se produljiti do
The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
5.2 Farmakokinetička svojstva Anorganski, liofilizirani oblik arsenovog trioksida odmah stvara hidrolitički produkt arsenične kiseline
TRISENOX 2 mg/ml concentrate for solution for infusion 3 years.
TRISENOX 2 mg/ml koncentrat za otopinu za infuziju 3 godine.
Eye disorders Vision blurred
Poremećaji oka zamućeni vid
Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during TRISENOX clinical trials in 52 patients with refractory/relapsed APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥ 1/1,000 to < 1/100), not known (cannot be estimated from available data).
Učestalosti se definiraju kao: (vrlo često ≥ 1/10), (često ≥ 1/100 i < 1/10), (manje često ≥ 1/1000 i
Negative Positive Not evaluable
Ne može se procijeniti
Cytogenetics after TRISENOX therapy Table 5
Citogenetika nakon terapije TRISENOXOM
Each ml of concentrate contains 2 mg of arsenic trioxide.
Jedan ml koncentrata sadrži 2 mg arsenovog trioksida.
- fatigue (weariness), pain, fever, headache
- otežano disanje - kašalj - bolovi u prsima
Each pack contains 10 vials.
Jedno pakiranje sadrži 10 bočica.
Pleural effusion
Mjera ishoda
Multicentre trial N with CR = 34
Multicentrično ispitivanje Bolesnici s potpunom remisijom = 34
• some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
primjerice kinidin, amiodaron, sotalol, dofetilid)
Very Common Very Common
Vrlo često umor
- 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
Vrlo često (javljaju se u više od jedne na 10 osoba): - umor (klonulost), bol, vrućica, glavobolja - mučnina, povraćanje, proljev - omaglica, bolovi u mišićima, obamrlost ili trnci - osip ili svrbež, povećana razina šećera u krvi, oticanje (oteklina zbog viška tekućine) - zadihanost, ubrzani srčani otkucaji, poremećeni EKG nalaz srca - smanjene razine kalija ili magnezija u krvi, poremećeni testovi jetrene funkcije uključujući prisutnost viška bilirubina ili gama- glutamiltransferaze u krvi
Cases of encephalopathy were reported with treatment with arsenic trioxide.
Uz liječenje arsenovim trioksidom zabilježeni su slučajevi encefalopatije.
Relapsed/refractory APL
APL u fazi relapsa/refraktoran na liječenje
Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland
Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co.
How TRISENOX is given
Kako se daje TRISENOX
The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 ml/min)
Plazmatski klirens AsIII u bolesnika s teškim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) bio je 40% niži u usporedbi s bolesnicima normalne bubrežne funkcije (vidjeti dio 4.4).
TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide
TRISENOX 1 mg/ml koncentrat za otopinu za infuziju arsenov trioksid
- reduction in blood cell counts (platelets, red and/or white blood cells), increased white blood cells - chills, increased weight - a fever due to an infection and low levels of white blood cells, herpes zoster infection - chest pain, bleeding in the lung, hypoxia (low oxygen level), collection of fluid around the heart or the lung, low blood pressure, abnormal heart rhythm - fit, joint or bone pain, inflammation of the blood vessels - increased sodium or magnesium, ketones in the blood and urine (ketoacidosis), renal function tests abnormal, kidney failure - stomach (abdominal) ache - redness of the skin, swollen face, blurred vision
- zimica, povećana tjelesna težina - vrućica zbog infekcije i niskih razina bijelih krvnih stanica, infekcija herpesom zosterom - bolovi u prsima, krvarenje u plućima, hipoksija (niska razina kisika), nakupljanje tekućine oko srca ili pluća, nizak krvni tlak, poremećeni srčani ritam