natgillin/translations-raw huggingface dataset:
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.
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.
You (or your child, if he/she is being treated) must not receive Atriance
Zdravila Atriance ne smete prejeti/vaš otrok (če se on/ona zdravi) ne sme prejeti
Atriance 5 mg/ml solution for infusion
Atriance 5 mg/ml raztopina za infundiranje
- All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
- 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.
• All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• 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.
Infections and infestations Infection (including but not limited to; sepsis, bacteraemia, pneumonia, fungal infection)
Infekcijske in parazitske bolezni okužba (med drugimi tudi sepsa, bakteriemija, pljučnica in glivične okužbe)
If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.
Če zanosite med zdravljenjem z zdravilom Atriance, o tem nemudoma obvestite svojega zdravnika.
Consideration to appropriate birth control is recommended to be discussed with your doctor.
O primerni metodi kontracepcije se posvetujte s svojim zdravnikom.
Nelarabine showed in vitro cytotoxicity to monocytes and macrophages.
In vitro je nelarabin deloval citotoksično za monocite in makrofage.
38.0 µM.h (39 %), respectively.
45,0 µM (40 %), AUCinf pa 38,0 µM.h (39 %).
Atriance contains sodium
Zdravilo Atriance vsebuje natrij
Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Začetni simptomi vključujejo siljenje na bruhanje in bruhanje, zasoplost, neenakomeren srčni utrip, motnost urina, letargijo in/ali težave s sklepi.
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.
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).
Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
• if you (or your child, if he/she is being treated) have any kidney or liver problems.
• če imate/ima vaš otrok (če se on/ona zdravi) kakršnekoli težave z ledvicami ali jetri.
These may affect more than 1 in 10 people treated with Atriance.
Pojavijo se lahko pri več kot 1 od 10 bolnikov, ki se zdravijo z zdravilom Atriance.
• if you (or your child, if he/she is being treated) have any blood problems (for example anaemia).
• če imate težave s krvjo (ali jih ima vaš otrok, ki se zdravi) (na primer anemijo).
Instructions for handling and disposal of Atriance
NAVODILA ZA SHRANJEVANJE IN ODSTRANJEVANJE ZDRAVILA ATRIANCE
(%CV) VSS values were 115 l/m
Pri odraslih bolnikih je bila srednja vrednost (% KV) VSS nelarabina 115 l/m
low potassium levels may cause a feeling of weakness low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.
nizke koncentracije krvnega sladkorja, ki lahko povzročijo siljenje na bruhanje, znojenje, oslabelost, vrtoglavico, zmedenost in halucinacije.
Each vial contains 50 ml.
1 viala vsebuje 50 ml.
Neurotoxicity is the dose-limiting toxicity of nelarabine.
Nevrotoksičnost je toksični učinek nelarabina, ki omejuje velikost odmerka.
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.
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.
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.
In vitro se nelarabin in ara-G ne vežeta pomembneje na humane plazemske proteine (manj kot 25 %).
NEUROLOGICAL ADVERSE REACTIONS
NEVROLOŠKI NEŽELENI UČINKI
Children and adolescents (aged 21 years and younger) The recommended dose is 650 mg/m of body surface area per day.
Otroci in mladostniki (stari 21 let in mlajši) Priporočeni odmerek je 650 mg/m telesne površine na dan.
Respiratory, thoracic and mediastinal disorders Pleural effusion
Bolezni dihal, prsnega koša in mediastinalnega prostora plevralni izliv
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.
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).
Mean (%CV) intracellular araGTP Cmax and AUC values were 95.6 µM (139 %) and 2214 µM.h (263 %) at this dose.
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 %).
The effect of race on nelarabine and ara-G pharmacokinetics has not been specifically studied.
Vpliva rase na farmakokinetiko nelarabina ali ara-G niso posebej proučevali.
The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine.
Glavni način presnove nelarabina je O-demetilacija z adenozin-deaminazo, pri čemer nastane ara-G, ki se nato hidrolizira do gvanina.
• 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.
• 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.
Mean plasma ara-G Cmax and AUCinf values were 115 µM (16 %) and 571 µM.h (30 %), respectively.
Srednja plazemska vrednost Cmax ara-G je bila 115 µM (16 %), srednja plazemska vrednost AUCinf ara-G pa 571 µM.h (30 %).
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
- Ob naključnem stiku zdravila s kožo ali z očmi, morate površino, ki je bila v stiku, takoj sprati z velikimi količinami vode.
Storage of Atriance solution for infusion
Shranjevanje Atriance raztopine za infundiranje
Neurotoxicity is the dose-limiting toxicity associated with nelarabine therapy (see section 4.4).
Nevrotoksičnost je toksični učinek nelarabina, ki omejuje velikost odmerka (glejte poglavje 4.4).
Blood and lymphatic system disorders Febrile neutropenia
Bolezni krvi in limfatičnega sistema febrilna nevtropenija nevtropenija levkopenija trombocitopenija anemija
Mean plasma ara-G Cmax and AUCinf values were 60.1 µM (17 %) and 212 µM.h (18 %), respectively.
Srednja plazemska vrednost Cmax ara-G je bila 60.1 µM (17 %), srednja plazemska vrednost AUCinf ara-G pa 212 µM.h (18 %).
Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
1 ml Atriance raztopine za infundiranje vsebuje 5 mg nelarabina.
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
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
In a pharmacokinetic/pharmacodynamic cross study analysis, race had no apparent effect on nelarabine, ara-G, or intracellular ara-GTP pharmacokinetics.
Analiza presečne farmakokinetične/farmakodinamične študije ne kaže, da bi rasa očitneje vplivala na farmakokinetiko nelarabina, ara-G ali znotrajceličnega ara-GTP.
• Weight loss and loss of appetite (anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.
• Izgubljanje telesne mase, izguba apetita (neješčnost), bolečine v želodcu, bolečine v ustni votlini in razjede ali vnetje ustne sluznice.
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.
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.
(32 %) and 32.1 l/m
(32 %), pri pediatričnih bolnikih pa 32,1 l/m
Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
V povezavi z zdravljenjem z nelarabinom so poročali o levkopeniji, trombocitopeniji, anemiji in nevtropeniji (vključno s febrilno nevtropenijo).
This can even be life threatening.
Okužbe so lahko tudi smrtne.
Vascular disorders Hypotension
Žilne bolezni hipotenzija
Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Uporabo nelarabina mora nadzirati zdravnik, ki ima izkušnje z uporabo citotoksičnih zdravil.
Each vial contains 250 mg of nelarabine.
1 viala vsebuje 250 mg nelarabina.
Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Po odprtju viale je zdravilo Atriance stabilno do 8 ur pri temperaturi do 30 °C.
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.
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.
It may harm a baby if conceived before, during or soon after treatment.
Če ženska zanosi pred, med ali kmalu po zdravljenju, lahko zdravilo škoduje plodu.
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.
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.
MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Pri magnetnoresonančnem slikanju (MRS) so pri teh 2 bolnikih ugotovili spremembe, ki so bile v skladu s procesom demielinizacije v vratnem delu hrbtenjače.
No studies have been conducted in animals to assess the effects of nelarabine on fertility.
Študij o vplivu nelarabina na plodnost pri živalih niso izvedli.
These may affect up to 1 in 10 people treated with Atriance:
Pojavijo se lahko pri do 1 od 10 bolnikov, ki se zdravijo z zdravilom Atriance:
Full recovery from these reactions has not always occurred with cessation of nelarabine.
Po prekinitvi zdravljenja z nelarabinom bolniki, pri katerih so se pojavili ti neželeni učinki, niso vedno povsem okrevali.
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.
V kliničnih študijah so pri bolnikih, starih od 16 do 21 let, uporabljali oba odmerka, 650 mg/m in
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
Ti podatki so bili pridobljeni pri bolnikih z neodzivno levkemijo ali limfomom, ki so prejemali nelarabin v odmerku 1.500 mg/m
Atriance can make people feel drowsy or sleepy, both during and for some days after treatment.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Atriance lahko med zdravljenjem in še nekaj dni po zdravljenju povzroči občutek zaspanosti ali utrujenosti.
In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Razen tega se nekaj nelarabina hidrolizira tudi do metilgvanina, ki nato z O-demetilacijo preide v gvanin.
Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Spol ne vpliva na farmakokinetiko nelarabina ali ara-G.
Each ml of solution contains 1.725 mg (75 micromols) of sodium.
Pomožna snov z znanim učinkom 1 ml raztopine vsebuje 1,725 mg (75 mikromolov) natrija.
(104 %) and 125 l/h/m
(104 %), pri pediatričnih bolnikih pa 125 l/h/m
• Feeling drowsy and sleepy; headache; dizziness.
• Občutek zaspanosti in utrujenosti, glavobol, omotica.
Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Redno je treba spremljati celotno krvno sliko, vključno s številom trombocitov (glejte poglavji 4.4 in
- Pregnant staff should be excluded from working with this medicinal product.
- Nosečnice ne smejo rokovati z zdravilom.
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.
Pri uporabi nelarabina na dnevni osnovi ali po shemi na 1., 3. in 5. dan niso opazili kopičenja nelarabina ali ara-G v plazmi.
Four (44 %) of the nine refractory patients experienced a complete response to nelarabine.
Popolni odziv na nelarabin je bil dosežen pri štirih (44 %) od teh devetih neodzivnih bolnikov.
Each ml contains 5 mg of nelarabine.
1 ml vsebuje 5 mg nelarabina.
1 x 50 ml vial
1 viala x 50 ml
These may affect up to 1 in 1,000 people treated with Atriance
Pojavijo se lahko pri do 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Atriance:
Decreased renal function, which is more common in the elderly, may reduce ara-G clearance (see section 4.2).
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).
Stable for up to 8 hours at up to 30ºC once the vial is opened.
Po odprtju viale je zdravilo stabilno do 8 ur pri temperaturi do 30 °C.
Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid.
Gvanin z N-deaminacijo preide v ksantin, ki se nato nadalje oksidira do sečne kisline.
Breast-feeding should be discontinued during treatment with Atriance.
V času zdravljenja z zdravilom Atriance je treba z dojenjem prekiniti.
Your doctor also needs to know the following before you are given this medicine:
Preden boste prejeli/bo vaš otrok prejel to zdravilo, morate zdravnika tudi obvestiti:
Metabolism and nutrition disorders Hypoglycaemia
Presnovne in prehranske motnje hipoglikemija
6 x 50 ml vials
6 vial x 50 ml
A doctor or nurse will give you the dose of Atriance as an infusion (a drip).
Odmerek zdravila Atriance vam bo v obliki kapljične infuzije dal zdravnik ali medicinska sestra.
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.
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).
Sodium warning
Opozorilo o vsebnosti natrija
Very common: 15 (15%) Common: 3 (4%)
Pogosti: 5 (6 %)
• a type of leukaemia, called T-cell acute lymphoblastic leukaemia.
• obliko levkemije, ki se imenuje akutna limfoblastna levkemija celic T. Pri levkemiji je prisotno nenormalno veliko število belih krvnih celic.
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).
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.
What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Atriance raztopina za infundiranje je bistra, brezbarvna raztopina.
• Increased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.
• Zvišanje koncentracije bilirubina v krvi, kar lahko povzroči rumeno obarvanje kože in letargijo (globokemu spanju podobno stanje).
• 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.
Odrasli in mladostniki (stari 16 let in starejši) Običajni odmerek je 1.500 mg/m telesne površine na dan.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Tumour lysis syndrome (see also data from compassionate use programme and nonpivotal studies)
sindrom tumorske lize (glejte tudi podatke iz programa sočutne uporabe (compassionate use programme) in neključnih študij)
Gait abnormal
nenormalna drža
A total of 6 patients (21 %) [95 % CI: 8 %-41 %] achieved a complete response with or without haematological recovery.
Popolni odziv s hematološkim izboljšanjem ali brez njega je bil dosežen pri skupno 6 bolnikih (21 %) [95 % interval zaupanja: 8 %-41 %].
There have also been reports of reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
Poročali so tudi o učinkih, povezanih z demielinizacijo in ascendentno periferno nevropatijo, ki je bila podobna Guillain-Barréjevemu sindromu (glejte poglavje 4.8).
Renal clearance averaged 9.0 l/h/m
Pri 21 odraslih bolnikih je bil povprečni ledvični očistek nelarabina 9,0 l/h/m
Five of the 28 patients (18 %) [95 % CI: 6 %-37 %] treated with nelarabine achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts).
Popolni odziv (delež blastov v kostnem mozgu ≤ 5 %, brez drugih znakov bolezni in izboljšanje periferne krvne slike v celoti) je bil dosežen pri petih od 28 bolnikov (18 %) [95 % interval zaupanja: 6 %-37 %], ki so se zdravili z nelarabinom.
However, no undesirable effects were seen in the testes or ovaries of monkeys given nelarabine intravenously at doses up to approximately 32 % of the adult human dose on a mg/m basis for 30 consecutive days.
Pri opicah, ki so 30 zaporednih dni prejemale nelarabin intravensko v odmerkih, ki so na osnovi mg/m predstavljali približno do 32 % odmerka za odrasle bolnike, niso opazili neželenih učinkov na moda ali jajčnike.
Children and adolescents (aged 21 years and younger) The recommended dose of nelarabine for children and adolescents (aged 21 years and younger) is 650 mg/m administered intravenously over one hour daily for 5 consecutive days, repeated every
Otroci in mladostniki (stari 21 let in mlajši) Priporočeni odmerek nelarabina za otroke in mladostnike (stare 21 let ali mlajše) je 650 mg/m2.
Rhabdomyolysis, blood creatine phosphokinase increased (see “Postmarketing data”)
bolečine v udih rabdomioliza, zvišana koncentracija kreatin fosfokinaze v krvi (glejte
(36 %) in paediatric patients] on day 1.
(36 %) pri otrocih).
How to store Atriance
Kako boste prejemali zdravilo Atriance
Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
V primeru pojava drugih toksičnih učinkov, vključno s hematološko toksičnostjo, je treba razmisliti o odložitvi dajanja naslednjega odmerka.
• Low blood levels of some substances: low calcium levels, which may cause muscle cramps, abdominal cramps or spasms low magnesium levels, which may cause muscle weakness, confusion, "jerky" movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels.
Posledice so lahko mišična oslabelost, zmedenost, sunkoviti gibi, visok krvni tlak, nepravilni srčni ritem in oslabitev refleksov pri zelo nizkih koncentracijah magnezija v krvi.
CLINICAL PARTICULARS
Citotoksično zdravilo
Cleft palate was seen in rabbits given a dose approximately 2-fold the adult human dose, absent pollices in rabbits given a dose approximately 79 % of the adult human dose while absent gall bladder, accessory lung lobes, fused or extra sternebrae and delayed ossification was seen at all doses.
Pri odmerkih, ki so bili približno 2krat večji od odmerka za odrasle bolnike, so pri kuncih opazili razcepljeno nebo, pri odmerkih, ki so predstavljali približno 79 % odmerka za odrasle bolnike, pa odsotnost prstov.
Severe neurological reactions have been reported with the use of nelarabine.
Pri uporabi nelarabina so poročali o pojavu resnih nevroloških učinkov.
• a type of lymphoma, called T-cell lymphoblastic lymphoma.
• obliko limfoma, ki se imenuje limfoblastni limfom celic T. Pri tem limfomu pride do kopičenja limfoblastov, vrste belih krvnih celic.
Adults and adolescents (aged 16 years and older) The recommended dose of nelarabine for adults and adolescents aged 16 years and older is 1,500 mg/m administered intravenously over two hours on days 1, 3 and 5 and repeated every
Priporočeni odmerek nelarabina za odrasle in mladostnike, stare 16 let ali starejše, je 1.500 mg/m Bolnik ga prejme na 1., 3. in 5. dan v obliki dvourne intravenske infuzije.
2.6 l/h/m
650 mg/m