FrancophonIA/ELRC3.0 huggingface dataset:
English: For the reversal of neutropenia and maintenance of normal neutrophil counts in patients with HIV infection, filgrastim is administered subcutaneously.
Slovenian: Za zaustavitev napredovanja nevtropenije in vzdrževanje normalnega števila nevtrofilcev pri bolnikih z okužbo s HIV, se filgrastim daje subkutano.
English: A subset of approximately 12% of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Slovenian: V podskupini približno 12% bolnikov, ki so imeli na začetku normalen citogenetski izvid, so pozneje med rednimi ponovnimi pregledi ugotovili nepravilnosti, vključno z monosomijo 7.
English: Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended.
Slovenian: Prezgodnja prekinitev zdravljenja s filgrastimom, preden število nevtrofilcev pade na pričakovano najnižjo raven, ni priporočljiva.
English: What Accofil looks like and contents of the pack
Slovenian: Izgled zdravila Accofil in vsebina pakiranja
English: An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja z večjo pogostnostjo pojavljanja izgube zarodkov pri kuncih pri velikih mnogokratnikih klinične izpostavljenosti in ob prisotnosti toksičnosti za samice (glejte poglavje 5.3).
English: Once the neutrophil nadir has been passed, the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Slovenian: Ko obdobje najnižjega števila nevtrofilcev mine, je treba dnevni odmerek filgrastima prilagoditi glede na odziv nevtrofilcev kot sledi:
English: Accofil is a clear colourless solution for injection or infusion in a pre-filled syringe marked with 1/40 printed markings from 0.1 mL to 1 mL on the syringe barrel, with an injection needle.
Slovenian: Zdravilo Accofil je bistra, brezbarvna raztopina za injiciranje ali infundiranje v napolnjeni injekcijski brizgi z merilno lestvico z 1/40 natisnjenimi oznakami od 0,1 ml do 1 ml na telesu brizge in z injekcijsko iglo.
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Slovenian: Poročali so o reakcijah GvHD in o smrtnih primerih pri bolnikih, ki so G-CSF prejemali po alogenski presaditvi kostnega mozga (glejte poglavji 4.4 in 5.1).
English: Continuous infusion with Accofil over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable half-lives.
Slovenian: Po neprekinjenem infundiranju zdravila Accofil , ki je pri bolnikih, ki okrevajo po avtologni presaditvi kostnega mozga, trajalo do 28 dni, ni bilo nobenih dokazov kopičenja zdravila v telesu in primerljivih razpolovnih eliminacijskih časov.
English: In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands and soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Slovenian: Pri bolnikih, pri katerih poteka presaditev matičnih celic ali kostnega mozga, se lahko pojavi bolezen presadka proti gostitelju (GvHD - Graft versus host disease); to je reakcija celic dajalca proti bolniku, ki prejme presadek; znaki in simptomi vključujejo izpuščaj na dlaneh in podplatih ter razjede in vnetja v ustih, na črevesju, jetrih, koži ali očeh, pljučih, nožnici in sklepih.
English: The blister packs are for individual syringes with prefixed needle safety guard.
Slovenian: Pretisni omoti so za posamezne brizge s predhodno nameščeno varnostno zaščito za iglo.
English: Oropharyngeal paina,e
Slovenian: kožni vaskulitis a
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factors, ATC code: L03AA02 Accofil is a biosimilar medicinal product.
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA02
English: You will normally receive your first dose of Accofil at least 24 hours after your chemotherapy and at least 24 hours after receiving your bone marrow transplant.
Slovenian: Običajno boste prejeli prvi odmerek Accofil vsaj 24 ur po kemoterapiji in vsaj 24 ur po presaditvi kostnega mozga.
English: PBPC mobilisation should be considered only in donors who meet normal clinical and laboratory eligibility criteria for stem cell donation.
Slovenian: Izplavljanje matičnih celic v periferno kri je primerno le pri dajalcih, ki izpolnjujejo običajna klinična in laboratorijska merila za darovanje matičnih celic.
English: The amount of Accofil you need will depend on the condition you are taking Accofil for and on your bodyweight.
Slovenian: Količina zdravila Accofil, ki jo boste potrebovali, je odvisna od bolezni, zaradi katere zdravilo Accofil uporabljate, in od vaše telesne mase.
English: The efficacy of the treatment was clear for this age group, which included most patients with congenital neutropenia.
Slovenian: Za to starostno skupino, ki je vključevala večino bolnikov s prirojeno nevtropenijo, je bila učinkovitost zdravljenja jasna.
English: Special precautions in recipients of allogeneic PBPC mobilised with filgrastim
Slovenian: Posebni ukrepi za prejemnike alogenskih PBPC, izplavljenih s filgrastimom
English: In normal donors, a 10 micrograms/kg/day dose administered subcutaneously for 4 - 5 consecutive days allows a collection of ≥ 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Slovenian: Pri večini zdravih dajalcev podkožno uporabljeni odmerek filgrastima 10 mikrogramov/kg/dan 4 do 5 zaporednih dni omogoča pridobitev ≥ 4 x 106 celic CD34+/kg telesne mase prejemnika po dveh levkaferezah.
English: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 109/L.
Slovenian: Filgrastim je treba dajati vsak dan s subkutano injekcijo, dokler število nevtrofilcev ne preseže vrednosti 1,5 x 109/L in ga je na tej ravni mogoče vzdrževati.
English: Mobilisation of PBPC does not provide a direct clinical benefit to normal donors and should only be considered for the purposes of allogeneic stem cell transplantation.
Slovenian: Izplavljanje matičnih celic v periferno kri zdravim dajalcem ne prinaša neposrednih kliničnih koristi, zato je namenjeno le alogenski presaditvi matičnih celic.
English: Use of filgrastim in adults with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in ANCs in peripheral blood and a reduction of infection and related events.
Slovenian: Uporaba filgrastima pri odraslih s hudo kronično nevtropenijo (huda prirojena, ciklična in idiopatska nevtropenija) povzroči dolgotrajno povečanje ANC v periferni krvi in zmanjša pogostnost okužb in z njimi povezanih zapletov.
English: Very commonly seen in normal stem cells donors is increase in white blood cells (leukocytosis) and decrease of platelets which reduces the ability of blood to clot (thrombocytopenia), these will be monitored by your doctor.
Slovenian: Pri zdravih dajalcih matičnih celic so zelo pogosto opazili povečanje števila belih krvnih celic (levkocitoza), zmanjšanje števila trombocitov, kar zmanjša sposobnost krvi za strjevanje (trombocitopenija), zato bo to spremljal zdravnik.
English: Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous or intravenous administration.
Slovenian: Kaže, da sledi očistek filgrastima farmakokinetiki prvega reda tako pri subkutani ali pri intravenski uporabi.
English: The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex) which may cause an allergic reaction.
Slovenian: Pokrovček igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijsko reakcijo.
English: It is unknown whether filgrastim or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se filgrastim ali njegovi presnovki izločajo v materino mleko.
English: In patients with SCN For congenital, idiopathic or cyclic neutropenia, filgrastim should be given by subcutaneous injection.
Slovenian: Za prirojeno, idiopatsko ali ciklično nevtropenijo se filgrastim daje s subkutano injekcijo.
English: Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Slovenian: Zdravilo Accofil je indicirano za skrajšanje trajanja nevtropenije in v primeru nastanka febrilne nevtropenije pri bolnikih, ki prejemajo citotoksično kemoterapijo za maligne tvorbe (z izjemo kronične mieloične levkemije in mielodisplastičnih sindromov), ter za skrajšanje trajanja nevtropenije pri bolnikih, ki se zdravijo z mieloablativno terapijo, ki ji sledi presaditev kostnega mozga, pri katerih obstaja povečano tveganje za dlje trajajočo hudo nevtropenijo.
English: Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Slovenian: Po koncu zdravljenja s filgrastimom se število nevtrofilcev v obtoku v 1 do 2 dneh zmanjša za 50%, na normalno raven pa se povrne v 1 do 7 dneh.
English: Infections and malignancies causing myelosuppression Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
Slovenian: Nevtropenija je lahko posledica infiltracije kostnega mozga z oportunističnimi okužbami, npr. kompleksom Mycobacterium avium ali malignimi obolenji, kot je limfom.
English: Physicians should exercise caution when considering the use of filgrastim in patients with sickle cell trait or sickle cell disease and only after careful evaluation of the potential risks and benefits.
Slovenian: Pri odločitvi za uporabo filgrastima pri bolnikih s srpastocelično dispozicijo ali srpastocelično anemijo morajo biti zdravniki previdni; za takšno zdravljenje naj se odločijo le po skrbni presoji možnih tveganj in koristi.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Slovenian: • spremenjen način telesnega reguliranja tekočin v telesu, ki lahko povzroči zabuhlost (motnje volumna tekočine)
English: Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x 109/L.
Slovenian: Z dajanjem filgrastima je treba prenehati ali njegov odmerek zmanjšati, če se število levkocitov poveča na > 70 x 109/L.
English: Each pack contains one, three, five, seven or ten pre-filled syringes, with or without a needle safety guard, and alcohol swab(s).
Slovenian: Eno pakiranje vsebuje eno, tri, pet, sedem ali deset napolnjenih injekcijskih brizg, z varnostno zaščito za iglo ali brez nje, in alkoholno(-imi) krpico(-ami).
English: The packs without blister are for syringes without needle safety guard.
Slovenian: Pakiranja brez pretisnega omota so za injekcijske brizge brez varnostne zaščite za iglo.
English: In view of the possible risk of microbial contamination, Accofil pre-filled syringes are for single use only.
Slovenian: Zaradi morebitnega tveganja za mikrobiološko kontaminacijo so napolnjene brizge zdravila Accofil namenjene samo za enkratno uporabo.
English: Individuals receiving filgrastim who report left upper abdominal and/ or shoulder tip pain should be evaluated for an enlarged spleen or splenic rupture.
Slovenian: Pri posameznikih, ki prejemajo filgrastim in navajajo bolečino v levem zgornjem delu trebuha in/ali na vrhu rame, je treba preveriti, ali je prišlo do povečanja ali raztrganja vranice.
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Slovenian: V splošnem niso ugotovili razlik v varnosti in učinkovitosti med osebami, starejšimi od 65 let, v primerjavi z mlajšimi odraslimi osebami (> 18 let), ki so prejemali citotoksično kemoterapijo.
English: Your doctor may test your blood at regular intervals to see how well the Accofil treatment is working.
Slovenian: Zdravnik bo redno izvajal krvne preiskave, da ugotovi, kako dobro deluje zdravljenje z zdravilom Accofil.
English: The most serious adverse reactions that may occur during Filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia and ARDS), capillary leak syndrome, severe splenomegaly/splenic rupture, transformation to myelodysplastic syndrome or leukaemia in SCN patients, GvHD in patients receiving allogeneic bone marrow transfer or peripheral blood cell progenitor cell transplant and sickle cell crisis in patients with sickle cell disease.
Slovenian: Najresnejši neželeni učinki, ki se lahko pojavijo med zdravljenjem s filgrastimom, vključujejo: anafilaktično reakcijo, hude neželene učinke na pljučih (vključno z intersticijsko pljučnico in sindromom dihalne stiske pri odraslem), sindrom povečane prepustnosti kapilar, hudo splenomegalijo/raztrganje vranice, preobrazbo v mielodisplastični sindrom ali levkemijo pri bolnikih s hudo kronično nevtropenijo, bolezen presadka proti gostitelju (GvHD - Graft versus Host Disease) pri bolnikih po alogenski presaditvi kostnega mozga ali presaditvi krvotvornih matičnih celic iz periferne krvi in srpastocelično krizo pri bolnikih s srpastocelično anemijo.
English: • Notice unusual bleeding or bruising that may be (these may be symptoms of a decrease in blood platelets (thrombocytopenia), with a reduced ability of your blood to clot.
Slovenian: • nenavadne krvavitve ali podplutbe (to so lahko simptomi zmanjšanja trombocitov v krvi (trombocitopenija) z zmanjšano sposobnostjo strjevanja krvi;
English: In those clinical trials, undesirable effects reported with equal frequency in cancer patients treated with filgrastim/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and pain.
Slovenian: V teh kliničnih preskušanjih so bili neželeni učinki, o katerih so z enako pogostnostjo poročali pri rakavih bolnikih, zdravljenih s filgrastimom/kemoterapijo in placebom/kemoterapijo, navzea in bruhanje, alopecija, driska, utrujenost, anoreksija, mukozitis, glavobol, kašelj, kožni izpuščaj, bolečine v prsnem košu, splošna oslabelost, vneto žrelo, zaprtost in bolečina.
English: Filgrastim is a protein produced in bacteria called Escherichia coli by recombinant DNA technology.
Slovenian: Filgrastim je beljakovina, pridobljena s pomočjo rekombinantne DNA tehnologije v bakteriji, imenovani Escherichia coli.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima pri odraslih in otrocih, ki prejemajo citotoksično kemoterapijo, podobni, kar nakazuje, da od starosti odvisnih razlik v farmakokinetiki filgrastima ni.
English: Based on reported data for another filgrastim product similar to Accofil, comparable findings plus increased fetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Slovenian: Na podlagi podatkov, o katerih so poročali pri drugem zdravilu s filgrastimom, podobnim zdravilu Accofil, so zabeležili primerljive izsledke ter več malformacij ploda pri odmerku 100 µg/kg/dan, tj. pri odmerku, toksičnem za samice, ki je ustrezal sistemski izpostavljenosti, ki je približno 50- do 90krat večja izpostavljenosti, ki so jo zabeležili pri bolnikih, ki so prejemali klinični odmerek 5 µg/kg/dan.
English: Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the prescribing information of the specific chemotherapy agents used).
Slovenian: Posebna previdnost je potrebna pri zdravljenju bolnikov, ki prejemajo velike odmerke kemoterapije, ker ni bilo dokazano, da bi se glede tumorja izboljšal izid zdravljenja in povečevanje odmerka kemoterapevtikov ima lahko za posledico povečanje škodljivih učinkov, vključno z učinki na srce, pljuča, živčevje in kožo (glejte informacije za predpisovanje posameznih kemoterapevtikov, ki so bili uporabljeni).
English: In the post-marketing setting, isolated cases of sickle cell crises have been reported in patients with sickle cell disease (see section 4.4).
Slovenian: V obdobju trženja so poročali o srpastocelični anemiji s posameznimi primeri srpastoceličnih kriz (glejte poglavje 4.4).
English: Accofil and severe chronic neutropenia (low number of a type of white blood cells)
Slovenian: Zdravilo Accofil in huda kronična nevtropenija (nizko število vrste belih krvnih celic)
English: Sweets syndrome (acute febrile neutrophili c dermatosis) Cutaneous
Slovenian: Sweetov sindrom (akutna febrilna nevtrofiln a dermatoz a)
English: The mechanism of vasculitis in patients receiving Filgrastim is unknown.
Slovenian: Mehanizem vaskulitisa pri bolnikih, ki prejemajo filgrastim, ni znan.
English: f. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Slovenian: f. Ko ste raztopino vbrizgali, iglo izvlecite, medtem pa še vedno pritiskajte na bat, nato pa kožo izpustite.
English: Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion diluted in glucose 50 mg/ml (5%) solution over 30 minutes.
Slovenian: Filgrastim se lahko daje dnevno v obliki subkutane injekcije ali v obliki 30 minutne intravenske infuzije raztopljene v raztopini glukoze 50 mg/ml (5%).
English: If you use more Accofil than you should, contact your doctor or pharmacist as soon as possible.
Slovenian: Če ste uporabili več zdravila Accofil, kot bi smeli Če ste uporabili več zdravila Accofil, kot bi smeli, se čimprej posvetujte z zdravnikom ali s farmacevtom.
English: The recommended dose of filgrastim is 0.5 MU/kg/day (5 micrograms/kg/day).
Slovenian: Priporočeni odmerek filgrastima je 0,5 M e./kg/dan (5 mikrogramov/kg/dan).
English: The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS).
Slovenian: Začetek pojavljanja pljučnih znakov, kot so na primer kašelj, zvišana telesna temperatura in dispneja ob hkratnih radioloških znakih pljučnih infiltratov in ob slabšanju delovanja pljuč, lahko pomeni začetek sindroma dihalne stiske pri odraslem (ARDS- Adult Respiratory Distress Syndrome).
English: Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Slovenian: Filgrastim se lahko daje v obliki neprekinjene subkutane infuzije ali subkutane injekcije.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,5 ml
English: In patients treated with myeloablative therapy followed by bone marrow transplantation The recommended starting dose of filgrastim is 1.0 MU/kg/day (10 micrograms/kg/day).
Slovenian: Bolniki, zdravljeni z mieloablativno terapijo, ki ji sledi presaditev kostnega mozga Priporočeni začetni odmerek filgrastima je 1,0 M e./kg/dan (10 mikrogramov/kg/dan).
English: INFORMATION IN BRAILLE Accofil 30 MU/0.5 ml
Slovenian: PODATKI V BRAILLOVI PISAVI Accofil 30 M e./0,5 ml
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 60 milijonov enot (M e.) (kar ustreza 600 mikrogramom [μg]) filgrastima.
English: PHARMACEUTICAL FORM Solution for injection or infusion Clear, colourless solution
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje ali infundiranje bistra, brezbarvna raztopina
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/L.
Slovenian: Za vzdrževanje ANC na ravni > 2,0 x 109/L bo morda potrebna dolgotrajna uporaba zdravila.
English: Accofil and peripheral blood stem cell transplantation (stem cells collected from the blood to use in bone marrow transplantation)
Slovenian: Zdravilo Accofil in presaditev matičnih celic iz periferne krvi (matične celice, zbrane v krvi, ki se uporabljajo za presaditev kostnega mozga)
English: Type I glass pre-filled syringe with a permanently attached stainless steel needle in the tip and 1/40 printed markings for graduations from 0.1 mL to 1 mL on the barrel.
Slovenian: Napolnjena injekcijska brizga iz stekla tipa I z neločljivo pritrjeno nerjavečo jekleno iglo na konici in merilno lestvico z 1/40 natisnjenimi oznakami od 0,1 ml do 1 ml na telesu brizge.
English: Accofil and neutropenia (low number of a type of white blood cells) associated with chemotherapy
Slovenian: Accofil in nevtropenija (nizko število vrste belih krvnih celic), povezana s kemoterapijo
English: Adverse events with higher incidence in Filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy
Slovenian: eNeželeni učinki z višjo pojavnostjo pri bolnikih, zdravljenih s filgrastimom, v primerjavi z bolniki, zdravljenimi s placebom, in povezani z osnovno maligno boleznijo ali citotoksično kemoterapijo
English: • if you experience a cough, fever and difficulty breathing (dyspnoea) as this can be a sign of Acute Respiratory Distress Syndrome (ARDS).
Slovenian: • če se pojavi kašelj, povišana telesna temperatura ali težave z dihanjem (dispneja), je to lahko znak sindroma akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome).
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Slovenian: Mesto vboda spreminjajte pri vsakem injiciranju in se tako izognite bolečini na eni strani.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima pri odraslih in otrocih, ki prejemajo citotoksično kemoterapijo, podobni.
English: EXP:
Slovenian: Accofil):
English: Special precautions in patients with acute myeloid leukaemia (AML)
Slovenian: Posebni previdnostni ukrepi pri bolnikih z akutno mieloično levkemijo (AML) Rast malignih celic
English: - The other ingredients are acetic acid, sodium hydroxide, sorbitol (E420), polysorbate 80 and water for injections.
Slovenian: - Druge sestavine zdravila so koncentrirana ocetna kislina, natrijev hidroksid, sorbitol (E420), polisorbat 80 in voda za injekcije.