FrancophonIA/ELRC3.0 huggingface dataset:
English: Atriance contains nelarabine which belongs to a group of medicines known as antineoplastic agents, used in chemotherapy to kill some types of cancer cells.
Slovenian: Zdravilo Atriance vsebuje nelarabin, ki spada v skupino zdravil, ki jih imenujemo antineoplastična zdravila in jih uporabljamo v kemoterapiji za uničenje nekaterih vrst rakavih celic.
English: Accumulation of ara-GTP in leukaemic blasts allows for preferential incorporation of ara-GTP into deoxyribonucleic acid (DNA) leading to inhibition of DNA synthesis.
Slovenian: Kopičenje ara-GTP v levkemičnih blastnih celicah omogoča želeno vgraditev ara-GTP v deoksiribonukleinsko kislino (DNA), kar vodi v zavrtje sinteze DNA.
English: (214 %) in adult and paediatric patients, respectively, on day 1 (n = 65 adults, n = 21 paediatric patients).
Slovenian: (214 %) (n = 65 odrasli bolniki, n = 21 otroci).
English: For patients at risk of hyperuricaemia, the use of allopurinol should be considered.
Slovenian: Pri bolnikih s tveganjem za pojav hiperurikemije je treba razmisliti o uporabi alopurinola.
English: Remember to tell your doctor if you start to take any other medicines while you are on Atriance.
Slovenian: Obvestite svojega zdravnika, če med zdravljenjem z zdravilom Atriance začnete jemati katerokoli drugo zdravilo.
English: Do not try and become pregnant/father a child until your doctor advises you it is safe to do so.
Slovenian: Zanosite oziroma oče lahko postanete šele, ko zdravnik presodi, da je to varno.
English: Patients must be cautioned that somnolence can affect performance of skilled tasks, such as driving.
Slovenian: Bolnika je treba opozoriti, da lahko somnolenca zmanjša sposobnost za opravljanje opravil, ki zahtevajo zbranost, npr. vožnja vozil.
English: Nelarabine and ara-G are rapidly eliminated from plasma with a half-life of approximately 30 minutes and 3 hours, respectively.
Slovenian: Nelarabin in ara-G se hitro izločita iz plazme, pri čemer je razpolovni čas nelarabina približno 30 minut, razpolovni čas ara-G pa približno 3 ure.
English: Family planning should be discussed with patients as appropriate.
Slovenian: Če je primerno, se je z bolnikom treba pogovoriti o načrtovanju družine.
English: In addition to the adverse reactions seen in the pivotal clinical studies, there are also data from 875 patients from NCI studies/compassionate use programme (694 patients) and Phase I (181 patients) studies of nelarabine.
Slovenian: Razen podatkov o neželenih učinkih iz ključnih kliničnih študij nelarabina, so na razpolago tudi podatki o 875 bolnikih, ki so bili vključeni v študije Nacionalnega onkološkega inštituta/program sočutne uporabe (694 bolnikov) in študije I. faze (181 bolnikov).
English: • Increases in blood levels of liver enzymes.
Slovenian: • Zvišanje koncentracije jetrnih encimov v krvi.
English: The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m2) and children (650 mg/m2) is based on data from 103 adults and 84 paediatric patients respectively.
Slovenian: Varnostni profil iz ključnih kliničnih študij s priporočenimi odmerki nelarabina za odrasle (1.500 mg/m2) in otroke (650 mg/m2) temelji na podatkih, pridobljenih pri 103 odraslih in 84 pediatričnih bolnikih.
English: 6 x 50 ml vials 250 mg/50 ml 1 x 50 ml vial 250 mg/50 ml
Slovenian: 6 vial x 50 ml 250 mg/50 ml 1 viala x 50 ml 250 mg/50 ml
English: There was a single additional report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult population.
Slovenian: Dodatno se poročali še o enem primeru odraslega bolnika s progresivno multifokalno levkoencefalopatijo, ki je bila potrjena z biopsijo.
English: Your doctor will take appropriate precautions to minimise the risk of this.
Slovenian: Zdravnik bo z ustreznimi ukrepi tveganje za pojav tega neželenega učinka zmanjšal na najmanjšo možno mero.
English: This medicinal product contains 1.725 mg/ml (75 micromols/ml) of sodium.
Slovenian: To zdravilo vsebuje 1,725 mg/ml (75 mikromolov/ml) natrija.
English: Concomitant administration of nelarabine in combination with adenosine deaminase inhibitors such as pentostatin is not recommended.
Slovenian: Sočasne uporabe nelarabina in zaviralcev adenozin-deaminaze, kot je pentostatin, ne priporočamo.
English: Limited clinical pharmacology data are available for patients below the age of 4 years (see section 5.2).
Slovenian: Za bolnike, mlajše od 4 let, so na voljo le omejeni klinični farmakološki podatki (glejte poglavje 5.2).
English: • Muscle pain.
Slovenian: • Bolečine v mišicah.
English: • High body temperature (fever); tiredness; feeling weak/loss of strength.
Slovenian: • Zvišana telesna temperatura (vročina), utrujenost in občutek oslabelosti/izgube moči.
English: (paediatrics).
Slovenian: (otroci).
English: It is likely that nelarabine overdose would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression and potentially death.
Slovenian: Posledica prevelikega odmerjanja nelarabina bo verjetno huda nevrotoksičnost (možno s paralizo in komo), mielosupresija in možna smrt.
English: Amnesia
Slovenian: amnezija
English: What Atriance is and what it is used for What you need to know before you are given Atriance How Atriance is given
Slovenian: Kaj je zdravilo Atriance in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Atriance Kako boste prejemali zdravilo Atriance Možni neželeni učinki
English: VIAL LABEL
Slovenian: NALEPKA ZA VIALO
English: If this does occur, it is most likely to occur at the first dose.
Slovenian: Največja verjetnost za pojav teh simptomov je pri prejemu prvega odmerka.
English: For ara-G, mean VSS/F values were 44.8 l/m
Slovenian: Srednje vrednost VSS/F ara-G je bila pri odraslih 44,8 l/m
English: The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Slovenian: Upoštevati morate običajne postopke za pravilno ravnanje s protitumorskimi zdravili in njihovo ustrezno odstranjevanje, in sicer:
English: • Problems with memory, feeling disoriented; blurred vision; altered or loss of sense of taste (dysgeusia).
Slovenian: • Težave s spominom, občutek dezorientiranosti, zamegljen vid, sprememba ali izguba čuta za okušanje (paragevzija).
English: • The release of tumour cell contents (tumour lysis syndrome), which may put extra stress on your body.
Slovenian: • Sproščanje vsebine tumorskih celic (sindrom tumorske lize), ki lahko telo še dodatno obremeni.
English: Insufficient numbers of patients aged 65 years of age and older have been treated with nelarabine to determine whether they respond differently than younger patients (see sections 4.4 and 5.2).
Slovenian: Zaradi nezadostnega števila bolnikov, starih 65 let in starejših, ki so se zdravili z nelarabinom, morebitnega drugačnega odziva pri starostnikih glede na mlajše bolnike ni bilo mogoče ugotoviti (glejte poglavji 4.4 in 5.2).
English: The effect of nelarabine on fertility in humans is unknown.
Slovenian: Vpliv nelarabina na plodnost pri človeku ni znan.
English: Patients receiving nelarabine are recommended to receive intravenous hydration according to standard medical practice for the management of hyperuricaemia in patients at risk of tumour lysis syndrome.
Slovenian: Pri bolnikih, ki prejemajo nelarabin, priporočamo intravensko dovajanje tekočine v skladu z običajno zdravniško prakso preprečevanja hiperurikemije pri bolnikih s tveganjem za pojav sindroma tumorske lize.
English: Adults and children in clinical studies were categorized into the three groups according to renal impairment: normal with Clcr greater than 80 ml/min (n = 56), mild with Clcr equalling 50 to 80 ml/min (n = 12), and moderate with Clcr less than 50 ml/min (n = 2).
Slovenian: V kliničnih študijah so bili odrasli in otroci razvrščeni v tri skupine glede na okvaro ledvic: z normalnim delovanjem ledvic (Clcr večji od 80 ml/min (n = 56)), z blago ledvično okvaro (Clcr enak 50 do 80 ml/min (n = 12)) in z zmerno ledvično okvaro (Clcr manjši od 50 ml/min (n = 2)).
English: There are no or limited amount of data from the use of nelarabine in pregnant women.
Slovenian: Podatkov o uporabi nelarabina pri nosečnicah ni oziroma jih je malo.
English: It is usually dripped into your arm over a period of about 1 hour.
Slovenian: Infuzija običajno teče po kapljicah v roko približno 1 uro.
English: Concomitant administration may reduce the efficacy of nelarabine and/or change the adverse event profile of either active substance.
Slovenian: Pri sočasni uporabi se lahko zmanjša učinkovitost nelarabina ali spremeni profil neželenih učinkov katerekoli od zdravilnih učinkovin ali oboje.
English: In vitro, T-cells are more sensitive than B-cells to the cytotoxic effects of nelarabine.
Slovenian: In vitro so celice T bolj dovzetne za citotoksične učinke nelarabina kot celice B.
English: Clinical studies of nelarabine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Slovenian: V klinične študije z nelarabinom ni bilo vključeno zadostno število bolnikov, starih 65 let in starejših, zato morebitnega drugačnega odziva pri starostnikih glede na mlajše bolnike ni bilo mogoče ugotoviti.
English: • Build up of fluid around the lungs leading to chest pain and difficulty in breathing (pleural effusion); wheezing
Slovenian: • Nabiranje tekočine okrog pljuč, kar povzroči bolečino v prsih in težave pri dihanju (plevralni izliv), piskanje.
English: Oedema peripheral
Slovenian: periferni edem
English: Other medicines and Atriance
Slovenian: Druga zdravila in zdravilo Atriance
English: These reactions have included altered mental states including severe somnolence, confusion and coma, central nervous system effects including convulsions, ataxia and status epilepticus, and peripheral neuropathy including hypoesthesia ranging from numbness and paresthesias to motor weakness and paralysis.
Slovenian: Ti učinki so vključevali spremembe duševnega stanja, vključno s hudo somnolenco, zmedenostjo in komo, učinke na centralni živčni sistem, vključno s konvulzijami, ataksijo in epileptičnim statusom, ter periferno nevropatijo, vključno s hipestezijo v razponu od odrevenelosti in parestezije do motorične oslabelosti in paralize.
English: In this case, its cells are called lymphoblasts.
Slovenian: V tem primeru so to limfoblasti.
English: You/your child (if he/she is being treated) will have an infusion (a drip) once a day for 5 days.
Slovenian: Kapljično infuzijo boste prejemali/bo vaš otrok (če se on/ona zdravi) prejemal 5 dni enkrat na dan.
English: If you have any questions about your illness, talk to your doctor.
Slovenian: Če imate kakršnokoli vprašanje o bolezni, se posvetujte s svojim zdravnikom.
English: Limited clinical pharmacology data are available for patients below the age of 4 years.
Slovenian: Za bolnike, mlajše od 4 let, so na voljo le omejeni klinični farmakološki podatki.
English: Survival at one year was 29 % [95 % CI: 12 %-45 %].
Slovenian: Enoletno preživetje je bilo 29-odstotno [95 % interval zaupanja: 12 %-45 %].
English: It is provided in clear glass vials with a rubber stopper and sealed with an aluminium cap.
Slovenian: Na voljo je v prozornih steklenih vialah, ki so zaprte z gumijastim zamaškom in zapečatene z aluminijasto zaporko.
English: WARNING: Cytotoxic agent, special handling instructions (see package leaflet).
Slovenian: OPOZORILO: Citotoksično zdravilo, posebni varnostni ukrepi za ravnanje z zdravilom (glejte Navodilo za uporabo).
English: Atriance is not recommended for pregnant women.
Slovenian: Uporaba zdravila Atriance pri nosečnicah ni priporočljiva.
English: Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by adenosine deaminase (ADA) to ara-G and then phosphorylated intracellularly by deoxyguanosine kinase and deoxycytidine kinase to its 5'-monophosphate metabolite.
Slovenian: Nelarabin je predzdravilo analoga deoksigvanozina ara-G. Nelarabin se z adenozin-deaminazo (ADA) hitro demetilira v ara-G, v celici pa se nato z deoksigvanozin-kinazo in deoksicitidin-kinazo fosforilira v 5'-monofosfatni presnovek.
English: • Staff should be trained in how to handle and transfer the medicinal product.
Slovenian: • Osebje mora biti ustrezno usposobljeno za rokovanje z zdravilom in njegovo aplikacijo.
English: At a dose of 2200 mg/m given on days 1, 3 and
Slovenian: Pri uporabi odmerka 2.200 mg/m na 1., 3. in 5. dan vsakih
English: It is usually dripped into your arm over a period of about 2 hours.
Slovenian: Infuzija običajno teče po kapljicah v roko približno 2 uri.
English: Patients with renal impairment must be closely monitored for toxicities when treated with nelarabine.
Slovenian: Bolnike z ledvično okvaro je treba med zdravljenjem z nelarabinom skrbno nadzirati glede pojava toksičnih učinkov.
English: Neoplasms benign and malignant (including cysts and polyps) Tumour lysis syndrome - 7 cases (see sections 4.2 and 4.4)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Sindrom tumorske lize - 7 primerov (glejte poglavji 4.2 in 4.4)
English: Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens and 31 whom had received one prior induction regimen, were treated with 650 mg/m2/day of nelarabine administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.
Slovenian: Štiriinosemdeset (84) bolnikov, od katerih jih je 39 predhodno bilo zdravljenih z dvema ali več indukcijskimi režimi zdravljenja, 31 pa z enim indukcijskim režimom zdravljenja, je nelarabin prejemalo v odmerku 650 mg/m2/dan v obliki enourne intravenske infuzije 5 zaporednih dni enkrat dnevno.
English: Nelarabine must be discontinued at the first sign of neurological events of National Cancer Institute Common Terminology Criteria Adverse Event (NCI CTCAE) grade 2 or greater.
Slovenian: Zdravljenje z nelarabinom je treba prekiniti ob pojavu prvega znaka nevroloških toksičnih dogodkov stopnje 2 ali večje po enotni razvrstitvi meril neželenih dogodkov Nacionalnega onkološkega inštituta (NCI CTCAE; “National Cancer Institute Common Terminology Criteria Adverse Event”).
English: Carcinogenicity testing of nelarabine has not been performed.
Slovenian: Preskušanj kancerogenega delovanja nelarabina niso izvedli.
English: • if you (or your child, if he/she is being treated) have recently been, or plan to be vaccinated with a live vaccine (for example polio, varicella, typhoid).
Slovenian: • če ste pred kratkim bili cepljeni/je vaš otrok (če se on/ona zdravi) pred kratkim bil cepljen ali boste cepljeni/bo cepljen z živim cepivom (na primer cepivo proti otroški ohromelosti, cepivo proti noricam ali cepivo proti tifusu).
English: Intracellular ara-GTP concentrations in leukaemic blasts were quantifiable for a prolonged period after nelarabine administration.
Slovenian: Znotrajcelične koncentracije ara-GTP v levkemičnih blastnih celicah so bile merljive daljši čas po aplikaciji nelarabina.
English: Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Slovenian: Podatki, ki podpirajo ti indikaciji, so zaradi majhnega števila tovrstnih bolnikov omejeni.
English: On the day 1, 3, and 5 schedule, Cmax and AUC(0-t) values on day 3 were approximately 50 % and 30 %, respectively, greater than Cmax and AUC(0-t) values on day 1.
Slovenian: Po shemi na 1., 3. in 5. dan so bile vrednosti Cmax na 3. dan za približno 50 % večje od vrednosti Cmax na 1. dan, vrednosti AUC(0-t) pa so bile na 3. dan za približno 30 % večje od vrednosti AUC(0-t) na 1. dan.
English: Of the 39 patients who had received two or more prior induction regimens, 5 (13 %) [95 % CI: 4 %27 %] achieved a complete response (bone marrow blast counts ≤ 5 %, no other evidence of disease, and full recovery of peripheral blood counts) and 9 (23 %) [95 % CI: 11 %-39 %] achieved complete responses with or without full haematological recovery.
Slovenian: Od 39 bolnikov, ki so se predhodno zdravili z dvema ali več indukcijskimi režimi zdravljenja, je bil pri 5 (13 %) [95 % interval zaupanja: 4 %-27 %] dosežen popolni odziv (delež blastov v kostnem mozgu ≤ 5 %, brez drugih znakov bolezni in izboljšanje periferne krvne slike v celoti), pri 9 (23 %) [95 % interval zaupanja: 11 %-39 %] pa popolni odziv s hematološkim izboljšanjem ali brez njega.
English: Median overall survival was 20.6 weeks [95 % CI: 10.4-36.4].
Slovenian: Srednja celotna doba preživetja je bila 20,6 tednov [95 % interval zaupanja: 10,4-36,4].
English: It is not known whether Atriance is passed on through breast milk.
Slovenian: Ni znano, če se zdravilo Atriance izloča z materinim mlekom.
English: Excipients: Sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Slovenian: Pomožne snovi: natrijev klorid, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
English: (159 %) and 89.4 l/m
Slovenian: (159 %), pri pediatričnih pa 89,4 l/m
English: The type of leukaemia relates to the type of white blood cell mainly involved.
Slovenian: Oblika levkemije je odvisna od vrste belih krvnih celic, ki je prizadeta.
English: Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Slovenian: Znano je, da je nelarabin za sesalske celice genotoksičen (glejte poglavje 5.3).
English: If a patient becomes pregnant during treatment with nelarabine, they should be informed of the possible risk to the foetus.
Slovenian: Če bolnica med zdravljenjem z nelarabinom zanosi, ji je treba pojasniti možno tveganje za plod.
English: Compared to controls, nelarabine caused increased incidences of foetal malformations, anomalies, and variations in rabbits when given at doses approximately 24 % of the adult human dose on a mg/m basis during the period of organogenesis.
Slovenian: V primerjavi s kontrolnimi učinkovinami je nelarabin pri plodovih kuncev povzročil večjo pojavnost malformacij, anomalij in variacij pri dajanju med obdobjem organogeneze v odmerkih, ki so na osnovi mg/m predstavljali približno 24 % odmerka za odrasle bolnike.
English: If you have any concerns, discuss them with your doctor.
Slovenian: Če ste kakorkoli zaskrbljeni, se posvetujte s svojim zdravnikom.
English: Complete blood counts including platelets must be monitored regularly (see sections 4.2 and 4.8).
Slovenian: Redno je treba nadzirati celotno krvno sliko, vključno s številom trombocitov (glejte poglavji 4.2 in 4.8).
English: There are insufficient data to support a dose adjustment recommendation for patients with a renal clearance of creatinine Clcr less than 50 ml/min.
Slovenian: Zaradi nezadostnih podatkov ne moremo podati priporočil za prilagoditev odmerka pri bolnikih z ledvičnim kreatininskim očistkom Clcr, manjšim od 50 ml/min.
English: Aspartate aminotransferase increased
Slovenian: zvišana aktivnost aspartataminotransferaze
English: There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Slovenian: Poročali so tudi o dogodkih, povezanih z demielinizacijo in ascendentno periferno nevropatijo, podobno kot pri Guillain-Barréjevemu sindromu.
English: The monophosphate metabolite is subsequently converted to the active 5'-triphosphate form, ara-GTP.
Slovenian: Monofosfatni presnovek nato preide v aktivno 5'-trifosfatno obliko, araGTP.
English: Nervous system disorders Seizures (including convulsions, grand mal convulsions, status epilepticus)
Slovenian: Bolezni živčevja epileptični napadi (vključno s konvulzijami, napadi grand mal in epileptičnim statusom)
English: The dose of Atriance you are given will be based on:
Slovenian: Odmerek zdravila, ki ga boste prejeli/ga bo prejel vaš otrok, je odvisen od:
English: Intracellular ara-GTP Cmax and AUC(0-t) values at the same dose level were 2- to 3- fold greater on average in adult female than in adult male patients.
Slovenian: Pri istem odmerku so bile znotrajcelične vrednosti Cmax in AUC(0-t) ara-GTP pri odraslih bolnicah v povprečju za 2- do 3-krat večje kot pri odraslih bolnikih.
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: Two paediatric patients had fatal neurological events.
Slovenian: Pri dveh otrocih je prišlo do nevrološkega dogodka s smrtnim izidom.
English: Nelarabine was mutagenic to L5178Y/TK mouse lymphoma cells with and without metabolic activation.
Slovenian: Nelarabin je na celicah mišjega limfoma L5178Y/TK deloval mutageno, in sicer s presnovno aktivacijo ali brez nje.
English: Nelarabine has been administered in clinical studies up to a dose of 75 mg/kg (approximately 2,250 mg/m2) daily for 5 days to a paediatric patient, up to a dose of 60 mg/kg (approximately 2,400 mg/m2) daily for 5 days to 5 adult patients and up to 2,900 mg/m in a further 2 adults on days 1,
Slovenian: V kliničnih študijah je en otrok prejemal nelarabin v odmerku do 75 mg/kg (približno 2.250 mg/m enkrat na dan 5 dni, 5 odraslih bolnikov v odmerku do 60 mg/kg (približno 2.400 mg/m2) enkrat na dan 5 dni, 2 odrasla bolnika pa v odmerku do 2.900 mg/m na 1., 3. in 5. dan.
English: Adult clinical study in relapsed or refractory T-ALL and T-LBL In an open-label study carried out by the Cancer and Leukaemia Group B and the Southwest Oncology Group, the safety and efficacy of nelarabine were evaluated in 39 adults with T-cell acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL).
Slovenian: Klinična študija pri odraslih s ponovitvijo bolezni ali neodzivno akutno limfoblastno levkemijo celic T (T-ALL) ali limfoblastnim limfomom celic T (T-LBL) V odprti študiji, ki sta jo izvedli raziskovalni skupini “Cancer and Leukaemia Group B” in “Southwest Oncology Group”, so varnost in učinkovitost nelarabina vrednotili pri 39 odraslih bolnikih z akutno limfoblastno levkemijo celic T (T-ALL) ali limfoblastnim limfomom celic T (T-LBL).
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that the clearance (Cl) and Vss values for nelarabine and ara-G are comparable between the two groups.
Slovenian: Kombinirani farmakokinetični podatki iz študij I. faze z odmerki nelarabina od 104 do 2.900 mg/m kažejo, da so vrednosti očistka (Cl) in Vss za nelarabin in ara-G med obema starostnima skupinama primerljive.
English: The prescribing physician should consider which regimen is appropriate when treating patients in this age range.
Slovenian: Ustrezni režim zdravljenja bolnikov v tem starostnem obdobju mora določiti lečeči zdravnik.
English: - Staff should be trained in how to handle and transfer the medicinal product.
Slovenian: - Osebje mora biti ustrezno usposobljeno za rokovanje z zdravilom in njegovo aplikacijo.
English: Further data with respect to nelarabine and ara-G pharmacokinetics in the paediatric population are provided in other subsections.
Slovenian: Drugi podatki o farmakokinetiki nelarabina in ara-G pri otrocih so navedeni v drugih podpoglavjih.
English: Psychiatric disorders Confusional state
Slovenian: Psihiatrične motnje zmedenost
English: Data from NCI studies/compassionate use programme and phase I studies
Slovenian: Podatki iz študij Nacionalnega onkološkega inštituta (National Cancer Institute)/programa sočutne uporabe (compassionate use programme) in študij I. faze
English: • Shortness of breath, difficult or laboured breathing; cough.
Slovenian: • Sopenje, težko ali naporno dihanje, kašelj.
English: The normal procedures for proper handling and disposal of cytotoxic anti-tumour medicinal products should be adopted, namely:
Slovenian: Upoštevati morate običajne postopke za pravilno ravnanje s citotoksičnimi protitumorskimi zdravili in njihovo ustrezno odstranjevanje, in sicer:
English: Symptoms may be mental (e.g. tiredness) or physical (e.g. convulsions, feelings of numbness or tingling, weakness and paralysis).
Slovenian: Simptomi so lahko psihični (npr. utrujenost) ali telesni (npr. krči, občutek odrevenelosti ali mravljinčenja, šibkost in paraliza).