FrancophonIA/ELRC3.0 huggingface dataset:
English: • Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
Slovenian: • Osebje, ki rokuje z zdravilom, mora med pripravo in aplikacijo zdravila nositi zaščitna oblačila, vključno z masko, zaščitnimi očali in rokavicami.
English: Musculoskeletal and connective tissue disorders Muscle weakness
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mišična oslabelost
English: Therefore, close monitoring for neurological reactions is strongly recommended, and nelarabine must be discontinued at the first sign of neurological reactions of NCI CTCAE Grade 2 or greater.
Slovenian: Bolnike je zato potrebno skrbno nadzirati glede pojava nevroloških učinkov in zdravljenje z nelarabinom prekiniti ob pojavu prvega znaka nevroloških toksičnih učinkov stopnje 2 ali večje po NCI CTCAE.
English: Stopping treatment with Atriance Your doctor will decide when to stop the treatment.
Slovenian: Prekinitev zdravljenja z zdravilom Atriance Odločitev o času prekinitve zdravljenja bo sprejel vaš zdravnik.
English: • Muscle weakness (possibly associated with peripheral neuropathy - see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.
Slovenian: • Mišična oslabelost (ki je lahko povezana s periferno nevropatijo - glejte zgoraj), bolečine v sklepih, bolečine v hrbtu, bolečine v rokah in nogah, vključno z mravljinčenjem in odrevenelostjo.
English: Clear glass (Type I) vial with a bromobutyl rubber stopper, and an aluminium seal with a red snap-off cap.
Slovenian: Prozorna steklena viala (steklo tipa I), zaprta z zamaškom iz bromobutilne gume in aluminijastim pečatom z rdečo zaskočno zaporko.
English: In 28 adult patients, 24 hours after nelarabine infusion on day 1, mean urinary excretion of nelarabine and ara-G was 5.3 % and 23.2 % of the administered dose, respectively.
Slovenian: Pri 28 odraslih bolnikih se je v 24 urah po prejemu infuzije nelarabina na 1. dan z urinom v povprečju izločilo 5,3 % nelarabina in 23,2 % ara-G glede na prejeti odmerek.
English: There is no known antidote for nelarabine overdose.
Slovenian: Za preveliko odmerjanje nelarabina antidot ni znan.
English: Atriance 5 mg/ml solution for infusion nelarabine
Slovenian: Atriance 5 mg/ml raztopina za infundiranje nelarabin
English: Infection and infestations
Slovenian: Infekcijske in parazitske bolezni
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Slovenian: • Ob naključnem stiku zdravila s kožo ali z očmi, morate površino, ki je bila v stiku, takoj sprati z velikimi količinami vode.
English: The appropriate dose of nelarabine must be transferred into polyvinylchloride (PVC) or ethyl vinyl acetate (EVA) infusion bags or glass containers and administered intravenously as a two-hour infusion in adult patients and as a one-hour infusion in paediatric patients.
Slovenian: Ustrezen odmerek nelarabina morate prenesti v polivinilkloridno (PVC) ali etilvinilacetatno (EVA) infuzijsko vrečko ali steklen vsebnik in uporabljati intravensko, pri odraslih v obliki dvourne infuzije, pri pediatričnih bolnikih pa v obliki enourne infuzije.
English: You (or your child, if he/she is being treated) must not receive Atriance
Slovenian: Zdravila Atriance ne smete prejeti/vaš otrok (če se on/ona zdravi) ne sme prejeti
English: Atriance 5 mg/ml solution for infusion
Slovenian: Atriance 5 mg/ml raztopina za infundiranje
English: - All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Slovenian: - Vse pripomočke, ki jih potrebujete pri aplikaciji zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za odstranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
English: • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Slovenian: • Vse pripomočke, ki jih potrebujete pri aplikaciji zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za odstranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
English: Infections and infestations Infection (including but not limited to; sepsis, bacteraemia, pneumonia, fungal infection)
Slovenian: Infekcijske in parazitske bolezni okužba (med drugimi tudi sepsa, bakteriemija, pljučnica in glivične okužbe)
English: If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.
Slovenian: Če zanosite med zdravljenjem z zdravilom Atriance, o tem nemudoma obvestite svojega zdravnika.
English: Consideration to appropriate birth control is recommended to be discussed with your doctor.
Slovenian: O primerni metodi kontracepcije se posvetujte s svojim zdravnikom.
English: Nelarabine showed in vitro cytotoxicity to monocytes and macrophages.
Slovenian: In vitro je nelarabin deloval citotoksično za monocite in makrofage.
English: 38.0 µM.h (39 %), respectively.
Slovenian: 45,0 µM (40 %), AUCinf pa 38,0 µM.h (39 %).
English: Atriance contains sodium
Slovenian: Zdravilo Atriance vsebuje natrij
English: Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Slovenian: Začetni simptomi vključujejo siljenje na bruhanje in bruhanje, zasoplost, neenakomeren srčni utrip, motnost urina, letargijo in/ali težave s sklepi.
English: Signs of an infection include: fever serious deterioration of your general condition local symptoms such as sore throat, sore mouth or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection) Tell your doctor immediately if you get any of these.
Slovenian: Znaki okužbe vključujejo: zvišano telesno temperaturo, resno poslabšanje splošnega zdravstvenega stanja, lokalizirane simptome, npr. vnetje žrela, vnetje ustne sluznice ali težave s sečili (na primer pekoč občutek med uriniranjem, ki je lahko znak okužbe sečil).
English: Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: • if you (or your child, if he/she is being treated) have any kidney or liver problems.
Slovenian: • če imate/ima vaš otrok (če se on/ona zdravi) kakršnekoli težave z ledvicami ali jetri.
English: These may affect more than 1 in 10 people treated with Atriance.
Slovenian: Pojavijo se lahko pri več kot 1 od 10 bolnikov, ki se zdravijo z zdravilom Atriance.
English: • if you (or your child, if he/she is being treated) have any blood problems (for example anaemia).
Slovenian: • če imate težave s krvjo (ali jih ima vaš otrok, ki se zdravi) (na primer anemijo).
English: Instructions for handling and disposal of Atriance
Slovenian: NAVODILA ZA SHRANJEVANJE IN ODSTRANJEVANJE ZDRAVILA ATRIANCE
English: (%CV) VSS values were 115 l/m
Slovenian: Pri odraslih bolnikih je bila srednja vrednost (% KV) VSS nelarabina 115 l/m
English: low potassium levels may cause a feeling of weakness low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.
Slovenian: nizke koncentracije krvnega sladkorja, ki lahko povzročijo siljenje na bruhanje, znojenje, oslabelost, vrtoglavico, zmedenost in halucinacije.
English: Each vial contains 50 ml.
Slovenian: 1 viala vsebuje 50 ml.
English: Neurotoxicity is the dose-limiting toxicity of nelarabine.
Slovenian: Nevrotoksičnost je toksični učinek nelarabina, ki omejuje velikost odmerka.
English: Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Slovenian: Nelarabin je indiciran za zdravljenje bolnikov z akutno limfoblastno levkemijo celic T (T-ALL) in limfoblastnim limfomom celic T (T-LBL), pri katerih se bolezen na predhodno zdravljenje z vsaj dvema režimoma kemoterapije ni odzvala ali pa se je ponovila.
English: Nelarabine and ara-G are not substantially bound to human plasma proteins (less than 25 %) in vitro, and binding is independent of nelarabine or ara-G concentrations up to 600 µM.
Slovenian: In vitro se nelarabin in ara-G ne vežeta pomembneje na humane plazemske proteine (manj kot 25 %).
English: NEUROLOGICAL ADVERSE REACTIONS
Slovenian: NEVROLOŠKI NEŽELENI UČINKI
English: Children and adolescents (aged 21 years and younger) The recommended dose is 650 mg/m of body surface area per day.
Slovenian: Otroci in mladostniki (stari 21 let in mlajši) Priporočeni odmerek je 650 mg/m telesne površine na dan.
English: Respiratory, thoracic and mediastinal disorders Pleural effusion
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora plevralni izliv
English: Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation are potentially at increased risk for neurological adverse events (see section 4.2 - dose modification) and therefore concomitant intrathecal therapy and/or craniospinal irradiation is not recommended.
Slovenian: Pri bolnikih, ki so se predhodno zdravili z intratekalno kemoterapijo ali se z njo zdravijo sočasno, in bolnikih, ki so se predhodno zdravili s kraniospinalnim obsevanjem, je tveganje za pojav nevroloških neželenih učinkov večje (glejte poglavje 4.2 - Prilagoditev odmerka).
English: Mean (%CV) intracellular araGTP Cmax and AUC values were 95.6 µM (139 %) and 2214 µM.h (263 %) at this dose.
Slovenian: Pri tem odmerku je bila srednja znotrajcelična vrednost Cmax (% KV) ara-GTP 95,6 µM (139 %), srednja vrednost AUC pa 2.214 µM.h (263 %).
English: The effect of race on nelarabine and ara-G pharmacokinetics has not been specifically studied.
Slovenian: Vpliva rase na farmakokinetiko nelarabina ali ara-G niso posebej proučevali.
English: The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine.
Slovenian: Glavni način presnove nelarabina je O-demetilacija z adenozin-deaminazo, pri čemer nastane ara-G, ki se nato hidrolizira do gvanina.
English: • Changes in the sense of feeling in hands or feet, muscle weakness appearing as difficulty getting up from a chair, or difficulty walking (peripheral neuropathy); reduced sensitivity to light touch, or pain; abnormal sensations such as burning and, prickling, a sensation of something crawling on the skin.
Slovenian: • Spremembe čuta za tip v rokah ali nogah ali obojem, mišična oslabelost, ki se kaže s težavami pri vstajanju s stola ali težavami pri hoji (periferna nevropatija), zmanjšana občutljivost za rahel dotik ali bolečina, nenavadni občutki, npr. žarenja, zbadanja ali gomazenja v koži.
English: Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Slovenian: Srednja plazemska vrednost Cmax ara-G je bila 115 µM (16 %), srednja plazemska vrednost AUCinf ara-G pa 571 µM.h (30 %).
English: - Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Slovenian: - Ob naključnem stiku zdravila s kožo ali z očmi, morate površino, ki je bila v stiku, takoj sprati z velikimi količinami vode.
English: Storage of Atriance solution for infusion
Slovenian: Shranjevanje Atriance raztopine za infundiranje
English: Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
Slovenian: Nevrotoksičnost je toksični učinek nelarabina, ki omejuje velikost odmerka (glejte poglavje 4.4).
English: Blood and lymphatic system disorders Febrile neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema febrilna nevtropenija nevtropenija levkopenija trombocitopenija anemija
English: Mean plasma ara-G Cmax and AUCinf values were 60.1 µM (17 %) and 212 µM.h (18 %), respectively.
Slovenian: Srednja plazemska vrednost Cmax ara-G je bila 60.1 µM (17 %), srednja plazemska vrednost AUCinf ara-G pa 212 µM.h (18 %).
English: Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
Slovenian: 1 ml Atriance raztopine za infundiranje vsebuje 5 mg nelarabina.
English: Paediatric patients After infusion of 400 or 650 mg/m nelarabine over one hour in 6 paediatric patients, mean (%CV) plasma nelarabine Cmax and AUCinf values, adjusted to a 650 mg/m dose, were 45.0 µM (40 %) and
Slovenian: Pediatrični bolniki Po enourni infuziji nelarabina v odmerku 400 ali 650 mg/m so bile pri 6 pediatričnih bolnikih srednje plazemske vrednosti Cmax in AUCinf nelarabina, prilagojene na odmerek 650 mg/m2, naslednje: Cmax
English: In a pharmacokinetic/pharmacodynamic cross study analysis, race had no apparent effect on nelarabine, ara-G, or intracellular ara-GTP pharmacokinetics.
Slovenian: Analiza presečne farmakokinetične/farmakodinamične študije ne kaže, da bi rasa očitneje vplivala na farmakokinetiko nelarabina, ara-G ali znotrajceličnega ara-GTP.
English: • Weight loss and loss of appetite (anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.
Slovenian: • Izgubljanje telesne mase, izguba apetita (neješčnost), bolečine v želodcu, bolečine v ustni votlini in razjede ali vnetje ustne sluznice.
English: The MAH shall provide yearly updates on any new information concerning the efficacy and safety of the product in patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo letno posredoval podatke o katerih koli novih informacijah, ki zadevajo učinkovitost in varnost zdravila pri bolnikih z akutno limfoblastno levkemijo celic T (T-ALL) in limfoblastnim limfomom celic T (T-LBL), pri katerih se bolezen na predhodno zdravljenje z vsaj dvema režimoma kemoterapije ni odzvala ali pa se je ponovila.
English: (32 %) and 32.1 l/m
Slovenian: (32 %), pri pediatričnih bolnikih pa 32,1 l/m
English: Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Slovenian: V povezavi z zdravljenjem z nelarabinom so poročali o levkopeniji, trombocitopeniji, anemiji in nevtropeniji (vključno s febrilno nevtropenijo).
English: This can even be life threatening.
Slovenian: Okužbe so lahko tudi smrtne.
English: Vascular disorders Hypotension
Slovenian: Žilne bolezni hipotenzija
English: Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Slovenian: Uporabo nelarabina mora nadzirati zdravnik, ki ima izkušnje z uporabo citotoksičnih zdravil.
English: Each vial contains 250 mg of nelarabine.
Slovenian: 1 viala vsebuje 250 mg nelarabina.
English: Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Slovenian: Po odprtju viale je zdravilo Atriance stabilno do 8 ur pri temperaturi do 30 °C.
English: Nelarabine at a dose of 1500 mg/m2/day was administered intravenously over two hours on days 1, 3 and 5 of a 21 day cycle.
Slovenian: Bolniki so prejemali nelarabin v odmerku 1.500 mg/m2/dan v obliki dvourne intravenske infuzije na 1., 3. in 5. dan 21-dnevnega cikla.
English: It may harm a baby if conceived before, during or soon after treatment.
Slovenian: Če ženska zanosi pred, med ali kmalu po zdravljenju, lahko zdravilo škoduje plodu.
English: The most frequently occurring adverse events were fatigue; gastrointestinal disorders; haematological disorders; respiratory disorders; nervous system disorders (somnolence, peripheral neurological disorders [sensory and motor], dizziness, hypoaesthesia, paraesthesia, headache); and pyrexia.
Slovenian: Najpogostejši neželeni učinki so bili utrujenost, bolezni prebavil, bolezni krvi, bolezni dihal, bolezni živčevja (somnolenca, periferne nevrološke okvare [senzorične in motorične], omotičnost, hipestezija, parestezija, glavobol) in zvišana telesna temperatura.
English: MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Slovenian: Pri magnetnoresonančnem slikanju (MRS) so pri teh 2 bolnikih ugotovili spremembe, ki so bile v skladu s procesom demielinizacije v vratnem delu hrbtenjače.
English: No studies have been conducted in animals to assess the effects of nelarabine on fertility.
Slovenian: Študij o vplivu nelarabina na plodnost pri živalih niso izvedli.
English: These may affect up to 1 in 10 people treated with Atriance:
Slovenian: Pojavijo se lahko pri do 1 od 10 bolnikov, ki se zdravijo z zdravilom Atriance:
English: Full recovery from these reactions has not always occurred with cessation of nelarabine.
Slovenian: Po prekinitvi zdravljenja z nelarabinom bolniki, pri katerih so se pojavili ti neželeni učinki, niso vedno povsem okrevali.
English: In clinical studies, the 650 mg/m and 1,500 mg/m dose have both been used in patients in the age range 16 to 21 years.
Slovenian: V kliničnih študijah so pri bolnikih, starih od 16 do 21 let, uporabljali oba odmerka, 650 mg/m in
English: These findings were demonstrated in patients with refractory leukaemia or lymphoma given a dose of 1,500 mg/m nelarabine (adults) or a 650 mg/m
Slovenian: Ti podatki so bili pridobljeni pri bolnikih z neodzivno levkemijo ali limfomom, ki so prejemali nelarabin v odmerku 1.500 mg/m
English: Atriance can make people feel drowsy or sleepy, both during and for some days after treatment.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Atriance lahko med zdravljenjem in še nekaj dni po zdravljenju povzroči občutek zaspanosti ali utrujenosti.
English: In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Slovenian: Razen tega se nekaj nelarabina hidrolizira tudi do metilgvanina, ki nato z O-demetilacijo preide v gvanin.
English: Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Slovenian: Spol ne vpliva na farmakokinetiko nelarabina ali ara-G.
English: Each ml of solution contains 1.725 mg (75 micromols) of sodium.
Slovenian: Pomožna snov z znanim učinkom 1 ml raztopine vsebuje 1,725 mg (75 mikromolov) natrija.
English: (104 %) and 125 l/h/m
Slovenian: (104 %), pri pediatričnih bolnikih pa 125 l/h/m
English: • Feeling drowsy and sleepy; headache; dizziness.
Slovenian: • Občutek zaspanosti in utrujenosti, glavobol, omotica.
English: Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Slovenian: Redno je treba spremljati celotno krvno sliko, vključno s številom trombocitov (glejte poglavji 4.4 in
English: - Pregnant staff should be excluded from working with this medicinal product.
Slovenian: - Nosečnice ne smejo rokovati z zdravilom.
English: No accumulation of nelarabine or ara-G was observed in plasma after nelarabine administration on either a daily or a day 1, 3, 5 schedule.
Slovenian: Pri uporabi nelarabina na dnevni osnovi ali po shemi na 1., 3. in 5. dan niso opazili kopičenja nelarabina ali ara-G v plazmi.
English: Four (44 %) of the nine refractory patients experienced a complete response to nelarabine.
Slovenian: Popolni odziv na nelarabin je bil dosežen pri štirih (44 %) od teh devetih neodzivnih bolnikov.
English: Each ml contains 5 mg of nelarabine.
Slovenian: 1 ml vsebuje 5 mg nelarabina.
English: 1 x 50 ml vial
Slovenian: 1 viala x 50 ml
English: These may affect up to 1 in 1,000 people treated with Atriance
Slovenian: Pojavijo se lahko pri do 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Atriance:
English: Decreased renal function, which is more common in the elderly, may reduce ara-G clearance (see section 4.2).
Slovenian: Starost ne vpliva na farmakokinetiko nelarabina ali ara-G. Zaradi zmanjšanega delovanje ledvic, ki je pri starostnikih pogostejše, se lahko zmanjša očistek ara-G (glejte poglavje 4.2).
English: Stable for up to 8 hours at up to 30ºC once the vial is opened.
Slovenian: Po odprtju viale je zdravilo stabilno do 8 ur pri temperaturi do 30 °C.
English: Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid.
Slovenian: Gvanin z N-deaminacijo preide v ksantin, ki se nato nadalje oksidira do sečne kisline.
English: Breast-feeding should be discontinued during treatment with Atriance.
Slovenian: V času zdravljenja z zdravilom Atriance je treba z dojenjem prekiniti.
English: Your doctor also needs to know the following before you are given this medicine:
Slovenian: Preden boste prejeli/bo vaš otrok prejel to zdravilo, morate zdravnika tudi obvestiti:
English: Metabolism and nutrition disorders Hypoglycaemia
Slovenian: Presnovne in prehranske motnje hipoglikemija
English: 6 x 50 ml vials
Slovenian: 6 vial x 50 ml
English: A doctor or nurse will give you the dose of Atriance as an infusion (a drip).
Slovenian: Odmerek zdravila Atriance vam bo v obliki kapljične infuzije dal zdravnik ali medicinska sestra.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused histopathological changes to the central nervous system (white matter vacuolation and degenerative changes in cerebrum, cerebellum and spinal cord) of monkeys after daily treatment with nelarabine for 23 days, at exposures below the human therapeutic exposure.
Slovenian: Možen pomen za klinično uporabo je naslednji: pri vsakodnevnem zdravljenju z nelarabinom, ki je trajalo 23 dni, je nelarabin pri izpostavljenosti, ki je bila manjša od terapevtske izpostavljenosti človeka, pri opicah povzročil histopatološke spremembe v centralnem živčnem sistemu (vakuolizacija bele substance ter degenerativne spremembe v velikih možganih, malih možganih in hrbtnem mozgu).
English: Sodium warning
Slovenian: Opozorilo o vsebnosti natrija
English: Very common: 15 (15%) Common: 3 (4%)
Slovenian: Pogosti: 5 (6 %)
English: • a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
Slovenian: • obliko levkemije, ki se imenuje akutna limfoblastna levkemija celic T. Pri levkemiji je prisotno nenormalno veliko število belih krvnih celic.
English: Paediatric clinical study in relapsed or refractory T-ALL and T-LBL In an open-label, multicenter study carried out by Childrens Oncology Group, nelarabine was administered intravenously over 1 hour for 5 days to 151 patients ≤ 21 years of age, 149 of whom had relapsed or refractory T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Slovenian: Klinična študija pri pediatričnih bolnikih s ponovitvijo bolezni ali neodzivno akutno limfoblastno levkemijo celic T (T-ALL) ali limfoblastnim limfomom celic T (T-LBL) V odprti multicentrični študiji, ki jo je izvedla raziskovalna skupina “Childrens Oncology Group” (COG), je nelarabin v obliki enourne intravenske infuzije 5 dni prejemalo 151 bolnikov, starih ≤ 21 let.
English: What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Slovenian: Atriance raztopina za infundiranje je bistra, brezbarvna raztopina.
English: • Increased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.
Slovenian: • Zvišanje koncentracije bilirubina v krvi, kar lahko povzroči rumeno obarvanje kože in letargijo (globokemu spanju podobno stanje).
English: • the results of blood tests carried out before treatment Adults and adolescents (aged 16 years and older) The usual dose is 1,500 mg/m of body surface area per day.
Slovenian: Odrasli in mladostniki (stari 16 let in starejši) Običajni odmerek je 1.500 mg/m telesne površine na dan.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Tumour lysis syndrome (see also data from compassionate use programme and nonpivotal studies)
Slovenian: sindrom tumorske lize (glejte tudi podatke iz programa sočutne uporabe (compassionate use programme) in neključnih študij)
English: Gait abnormal
Slovenian: nenormalna drža