FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Primjena nelarabina mora se obustaviti na prvi znak neurološkoga događaja koji se prema kriterijima Nacionalnoga instituta za rak (NCI CTCAE; od engl.
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).
Croatian: U kliničkim ispitivanjima, odrasli ispitanici i ispitanici dječje dobi su s obzirom na stupanj oštećenja bubrežne funkcije kategorizirani u tri skupine, kako slijedi: ispitanici čija je bubrežna funkcija uredna, uz Clcr veći od 80 ml/min (n = 56), ispitanici s blago poremećenom bubrežnom funkcijom, uz Clcr od 50 do 80 ml/min (n = 12), te ispitanici s umjereno poremećenom bubrežnom funkcijom, uz Clcr manji od 50 ml/min (n = 2).
English: Mean plasma ara-G Cmax and AUCinf values were 60.1 µM (17 %) and 212 µM.h (18 %), respectively.
Croatian: Prosječna vrijednost Cmax ara-G u plazmi iznosila je 60,1 µM (17%), a vrijednost AUCinf 212 µM.h (18%).
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.
Croatian: Nositelj odobrenja će podnositi godišnje izvještaje o bilo kojoj novoj informaciji vezanoj uz djelotvornost i sigurnost ovog lijeka u bolesnika s akutnom limfoblastičnom leukemijom T-stanica (T-ALL) i limfoblastičnim limfomom T-stanica (T-LBL), u kojih je terapijski odgovor izostao ili je bolest recidivirala nakon primjene barem dva različita kemoterapijska protokola.
English: 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
Croatian: Odrasle osobe i adolescenti (u dobi od 16 i više godina) Preporučena doza nelarabina za odrasle i adolescente u dobi od 16 godina i starije iznosi 1500 mg/m primijenjena 1., 3. i 5. dan putem dvosatne intravenske infuzije te se ponavlja svakih 21 dan.
English: - Pregnant staff should be excluded from working with this medicinal product.
Croatian: • Trudnice ne bi smjele rukovati ovim lijekom.
English: In addition, some nelarabine is hydrolysed to form methylguanine, which is O-demethylated to form guanine.
Croatian: Uz to se dio nelarabina hidrolizira stvarajući metilgvanin, koji se O-demetilira u gvanin.
English: How to store Atriance
Croatian: Kako primjenjivati Atriance
English: Intracellular Cmax for ara-GTP appeared within 3 to 25 hours on day 1.
Croatian: Prvoga dana terapijskoga ciklusa, intracelularna Cmax ara-GTP-a postignuta je nakon 3 do 25 sati.
English: Mean (%CV) intracellular araGTP Cmax and AUC values were 95.6 µM (139 %) and 2214 µM.h (263 %) at this dose.
Croatian: Pri spomenutoj dozi, prosječna (%CV) vrijednost intracelularne Cmax ara-GTP-a iznosila je 95,6 µM (139%), a vrijednost AUC 2214 µM.h (263%).
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.
Croatian: Nelarabin je indiciran za liječenje oboljelih od akutne limfoblastične leukemije T-stanica (T-ALL) i limfoblastičnoga limfoma T-stanica (T-LBL), u kojih je terapijski odgovor izostao ili je bolest recidivirala nakon primjene barem dva različita kemoterapijska protokola.
English: (36 %) in paediatric patients] on day 1.
Croatian: (36%) u pedijatrijskih bolesnika].
English: • a type of lymphoma, called T-cell lymphoblastic lymphoma.
Croatian: • vrste limfoma nazvanoga limfoblastičnim limfomom T-stanica.
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).
Croatian: Cancer and Leukaemia Group B) i Jugozapadna skupina onkologa (Southwest Oncology Group, SWOG), sigurnosti primjene i djelotvornost nelarabina vrednovane su na uzorku od 39 odraslih osoba oboljelih od akutne limfoblastične leukemije T-stanica (T-ALL), odnosno limfoblastičnoga limfoma T-stanica (T-LBL).
English: There have been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.
Croatian: Postoje i izvješća o događajima povezanim s demijelinizacijom te izvješća o pojavi perifernih neuropatija uzlaznoga tipa, koje svojom kliničkom slikom podsjećaju na Guillain-Barréov sindrom.
English: Rhabdomyolysis and increased blood creatine phosphokinase have been identified during postapproval use of nelarabine.
Croatian: Rabdomioliza i povišenje vrijednosti kreatin fosfokinaze u krvi zabilježene su tijekom primjene nelarabina nakon dobivanja odobrenja za stavljanje lijeka u promet.
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.
Croatian: • Promjene osjeta u šakama ili stopalima, slabost mišića očitovana otežanim ustajanjem sa stolca ili otežanim hodom (periferna neuropatija); smanjena osjetljivost na blagi dodir ili bol;
English: Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Croatian: Atriance je stabilan do 8 sati pri temperaturi do 30°C.
English: Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Croatian: Navedene indikacije, zbog malog broja oboljelih od ovih rijetkih bolesti, podupiru malobrojni podaci.
English: Each ml of Atriance solution for infusion contains 5 mg of nelarabine.
Croatian: Jedan ml Atriance otopine za infuziju sadrži 5 mg nelarabina.
English: MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
Croatian: MR nalaz tih dvaju bolesnika pokazao je demijelinizaciju vratnog dijela kralježnične moždine.
English: • Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).
Croatian: • Porast razine kreatinina u krvi (kao znak bubrežnih tegoba, što može rezultirati rjeđim mokrenjem).
English: Nelarabine showed in vitro cytotoxicity to monocytes and macrophages.
Croatian: U in vitro uvjetima nelarabin se pokazao citotoksičnim za monocite i makrofage.
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
Croatian: Nakon jednosatne infuzije 400, odnosno 650 mg/m nelarabina u 6 pedijatrijskih bolesnika, prosječna (%CV) Cmax nelarabina u plazmi, iznosila je 45,0 µM (40%), a vrijednost AUCinf, prilagođena s obzirom na dozu od 650 mg/m
English: At a dose of 2200 mg/m given on days 1, 3 and
Croatian: Pri primjeni dnevne doze od 2200 mg/m
English: Thirteen (42 %) of the 31 patients treated with one prior induction regimen achieved a complete response overall.
Croatian: Ukupno gledano, potpuni odgovor postignut je u 13 (42%) od 31-og bolesnika ranije liječenih jednim indukcijskim protokolom.
English: Data from NCI studies/compassionate use programme and phase I studies
Croatian: National Cancer Institute)/podaci prikupljeni tijekom programa milosrdnog davanja lijeka i iz ispitivanja faze I
English: It is provided in clear glass vials with a rubber stopper and sealed with an aluminium cap.
Croatian: Dostupna je u bočicama od prozirnoga stakla s gumenim čepom, dodatno učvršćenim aluminijskim prstenom sa zatvaračem.
English: Age has no effect on the pharmacokinetics of nelarabine or ara-G.
Croatian: Dob nema utjecaja na farmakokinetiku nelarabina, odnosno ara-G.
English: There have been reports of sometimes fatal opportunistic infections in patients receiving nelarabine therapy.
Croatian: U bolesnika liječenih nelarabinom prijavljeni su i slučajevi ponekad smrtonosnih oportunističkih infekcija.
English: (32 %) and 32.1 l/m
Croatian: (32%), a ona u pedijatrijskih bolesnika 32,1 l/m
English: The mean apparent clearance (Cl/F) of ara-G was about 7 % lower in patients with mild renal impairment than in patients with normal renal function (see section 4.2).
Croatian: U bolesnika čija je bubrežna funkcija bila blago poremećena, prosječni detektibilni klirens (Cl/F) ara-G bio je oko 7% niži negoli u bolesnika čija je bubrežna funkcija bila uredna (vidjeti dio 4.2).
English: Hepatobiliary disorders Hyperbilirubinaemia
Croatian: Poremećaji jetre i žući Hiperbilirubinemija
English: Complete blood counts including platelets must be monitored regularly (see sections 4.4 and 4.8).
Croatian: Mora se redovito kontrolirati kompletna krvna slika, uključujući i trombocite (vidjeti dijelove 4.4 i
English: Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid.
Croatian: Gvanin se N-deaminira stvarajući ksantin, koji se potom oksidira u mokraćnu kiselinu.
English: • if you (or your child, if he/she is being treated) have any kidney or liver problems.
Croatian: • ako Vi (odnosno Vaše dijete, ako se ono liječi) imate problema s bubrezima ili jetrom.
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.
Croatian: U bolesnika liječenih nelarabinom u kojih postoji rizik od razvoja sindroma lize tumora, preporučuje se provoditi intravensku hidraciju sukladno standardnoj medicinskoj praksi, kako bi se na taj način riješila hiperuricemija.
English: In vitro, T-cells are more sensitive than B-cells to the cytotoxic effects of nelarabine.
Croatian: T-limfociti pokazuju veću osjetljivost na citotoksično djelovanje nelarabina nego B-limfociti.
English: The type of leukaemia relates to the type of white blood cell mainly involved.
Croatian: Vrsta leukemije određuje se na temelju najbrojnije podvrste bijelih krvnih stanica zahvaćene bolešću.
English: Respiratory, thoracic and mediastinal disorders Pleural effusion
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Pleuralni izljev
English: - All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Croatian: - Sve predmete korištene prilikom primjene ovoga lijeka ili čišćenja, uključujući i zaštitne rukavice, valja odložiti u vreće u koje se prikuplja visokorizični otpad, te njihov sadržaj spaliti pri visokim temperaturama.
English: Vascular disorders Hypotension
Croatian: Krvožilni poremećaji Hipotenzija
English: Each ml of solution contains 1.725 mg (75 micromols) of sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedan ml otopine sadrži 1,725 mg (75 mikromola) natrija.
English: What Atriance looks like and contents of the pack Atriance solution for infusion is a clear, colourless solution.
Croatian: Atriance otopina za infuziju je bistra, bezbojna otopina.
English: Nelarabine however, is known to be genotoxic to mammalian cells (see section 5.3).
Croatian: Karcinogenost nelarabina nije ispitivana, no poznato je da je nelarabin genotoksičan za stanice sisavaca (vidjeti dio 5.3).
English: This treatment may vary, depending on the results of regular blood tests.
Croatian: Ovakav protokol liječenja uobičajeno je ponavljati svaka tri tjedna, što se može mijenjati ovisno o rezultatima kontrolnih krvnih pretraga.
English: Maternal body weight gain and foetal body weights were reduced in rabbits given a dose approximately 2-fold the adult human dose.
Croatian: Prirast tjelesne težine skotne ženke i težina okota zečeva, tretiranih dozom dvostruko višom od one koja se inače primjenjuje u ljudi, bili su smanjeni.
English: Patients with renal impairment must be closely monitored for toxicities when treated with nelarabine.
Croatian: Bolesnike čija je bubrežna funkcija oštećena mora se pomno nadzirati za vrijeme trajanja liječenja nelarabinom, kako bi se pravodobno uočilo njegovo toksično djelovanje.
English: Leukopenia, thrombocytopenia, anaemia, and neutropenia, (including febrile neutropenia) have been associated with nelarabine therapy.
Croatian: Za vrijeme trajanja liječenja nelarabinom mogu se razviti leukopenija, trombocitopenija, anemija i neutropenija (uključujući i febrilnu neutropeniju).
English: Each ml contains 5 mg of nelarabine.
Croatian: Jedan ml sadrži 5 mg nelarabina.
English: These may affect more than 1 in 10 people treated with Atriance.
Croatian: One se mogu javiti u više od 1 na 10 osoba liječenih lijekom Atriance.
English: Twenty-eight of the 39 adults had relapsed or were refractory to at least two prior induction regimens and aged between 16 to 65 years of age (mean 34 years).
Croatian: U dvadeset osam od spomenutih 39 bolesnika, bolest je nakon barem dva indukcijska terapijska protokola recidivirala ili je bila refraktorna na liječenje, a bili su u dobi od 16 do
English: • your/your child's (if he/she is being treated) body surface area (which will be calculated by your doctor based on your height and weight).
Croatian: • veličini površine Vašega tijela (veličini površine tijela Vašega djeteta, ako se ono liječi)
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid, sodium hydroxide (see section 2 “Atriance contains sodium”).
Croatian: • Drugi sastojci su natrijev klorid, voda za injekcije, kloridna kiselina, natrijev hidroksid
English: Renal and urinary disorders Blood creatinine increased
Croatian: Poremećaji bubrega i mokraćnog sustava Povišenje kreatinina u krvi
English: Transaminases increased
Croatian: Povišenje vrijednosti transaminaza
English: 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
Croatian: Preporučena doza nelarabina u djece i adolescenata (u dobi od 21 godinu i mlađih) iznosi 650 mg/m a primjenjuje se intravenski kroz 5 uzastopnih dana putem jednosatne infuzije.
English: NEUROLOGICAL ADVERSE REACTIONS
Croatian: NEUROLOŠKE NUSPOJAVE
English: Nelarabine has not been studied in patients with hepatic impairment.
Croatian: Nelarabin nije ispitivan u osoba u kojih postoji oštećenje bubrežne funkcije.
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
Croatian: Ovi rezultati dobiveni su u skupini bolesnika oboljelih od refraktorne leukemije, odnosno refraktornoga limfoma, liječenih nelarabinom u dozi od 1500 mg/m
English: Each vial contains 250 mg of nelarabine.
Croatian: Jedna bočica sadrži 250 mg nelarabina.
English: There have also been reports of reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré Syndrome.
Croatian: Bilo je također izvješća o nuspojavama povezanim s demijelinizacijom, te pojavom perifernih neuropatija uzlaznoga tipa, čija klinička slika nalikuje Guillain-Barréovu sindromu (vidjeti dio 4.8).
English: 6 x 50 ml vials
Croatian: 6 bočica x 50 ml
English: Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts.
Croatian: U imunokompromitiranih bolesnika, cjepljenje „živim“ cjepivima može izazvati infekciju te se stoga ne preporučuje.
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.
Croatian: U okviru kliničkih ispitivanja, u bolesnika dobi 16 do 21 godine primjenjivane su doze od 650 mg/m i
English: Severe nervous system side effects have been reported with the use of Atriance.
Croatian: Za vrijeme liječenja lijekom Atriance prijavljene su teške nuspojave živčanog sustava.
English: 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.
Croatian: U zečeva prosječno 24% doze (iskazane u mg/m tretiranih dozom po prilici dvostruko većom od one koja se primjenjuje u ljudi, zamijećen je rascjep nepca, a u onih tretiranih dozom koja je iznosila oko 79% doze kojom se liječe odrasli bolesnici, uočen je nedostatak palaca.
English: These may affect up to 1 in 1,000 people treated with Atriance
Croatian: One se mogu javiti u do 1 na 1000 osoba liječenih lijekom Atriance:
English: Neurotoxicity is the dose-limiting toxicity of nelarabine.
Croatian: Neurotoksičnost nelarabina ovisna je o njegovoj dozi.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Tumour lysis syndrome (see also data from compassionate use programme and nonpivotal studies)
Croatian: Sindrom lize tumora (vidjeti i podatke prikupljene tijekom programa milosrdne primjene lijeka i podatke ispitivanja koja se ne ubrajaju u ključna)
English: These may affect up to 1 in 10 people treated with Atriance:
Croatian: One se mogu javiti u do 1 na 10 osoba liječenih lijekom Atriance:
English: Sodium warning
Croatian: Upozorenje na sadržaj natrija
English: Intracellular ara-GTP concentrations in leukaemic blasts were quantifiable for a prolonged period after nelarabine administration.
Croatian: Nakon primjene nelarabina, intracelularne koncentracije ara-GTP-a u leukemičnim blastima još su dulje vrijeme bile mjerljive.
English: • Serious disease that destroys skeletal muscle characterized by the presence of myoglobin (a breakdown product of muscle cells) in the urine (Rhabdomyolysis), increase in blood creatine phosphokinase.
Croatian: • Ozbiljna bolest koja razara skeletne mišiće, a karakterizirana je prisustvom mioglobina
English: Gender has no effect on nelarabine or ara-G plasma pharmacokinetics.
Croatian: Spol nema nikakvog utjecaja na farmakokinetiku nelarabina, odnosno ara-G.
English: Hypokalaemia
Croatian: Hipomagnezijemija
English: 1 x 50 ml vial
Croatian: 1 bočica x 50 ml
English: Plasma ara-G Cmax values generally occurred at the end of the nelarabine infusion and were generally higher than nelarabine Cmax values, suggesting rapid and extensive conversion of nelarabine to ara-G. After infusion of 1,500 mg/m nelarabine over two hours in adult patients, mean (%CV) plasma nelarabine Cmax and AUCinf values were 13.9 µM (81 %) and 13.5 µM.h (56 %) respectively.
Croatian: Nakon dvosatne infuzije nelarabina u dozi od 1500 mg/m2, njegova prosječna (%CV) Cmax u odraslih je bolesnika iznosila 13,9 µM (81%), a vrijednost AUCinf 13,5 µM.h (56%).
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.
Croatian: Podaci o sigurnosti primjene lijeka, potekli iz ključnih kliničkih ispitivanja, temeljeni su na podacima prikupljenim na uzorku od 103 odrasle osobe liječene preporučenom dozom nelarabina od 1500 mg/m i uzorku od 84 pedijatrijska bolesnika liječena preporučenom dozom nelarabina od
English: Paraesthesia
Croatian: Parestezije
English: 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.
Croatian: No, u majmuna koji su kroz 30 uzastopnih dana primali nelarabin u dozama i do 32% doze koja se inače primjenjuje u ljudi, nisu zamijećene nikakve nepoželjne promjene u testisima, odnosno jajnicima pokusnih životinja.
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).
Croatian: U otvorenom multicentričnom ispitivanju, koje je provela Skupina za pedijatrijsku onkologiju (u izvorniku: Childrens Oncology Group), nelarabin je primjenjivan kroz 5 uzastopnih dana putem jednosatne intravenske infuzije u skupini od 151 bolesnika u dobi
English: Each vial contains 50 ml of solution.
Croatian: Svaka bočica sadrži 50 ml otopine.
English: Stable for up to 8 hours at up to 30ºC once the vial is opened.
Croatian: Nakon otvaranja bočice otopina je stabilna do 8 sati na temperaturi do 30ºC.
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.
Croatian: Niti nakon svakodnevne primjene nelarabina, niti nakon njegove primjene 1., 3. i 5. dana terapijskoga ciklusa, nije zamijećeno nakupljanje nelarabina, odnosno ara-G u plazmi.
English: Severe neurological reactions have been reported with the use of nelarabine.
Croatian: Pri primjeni nelarabina primijećene su teške neurološke nuspojave.
English: Combined Phase 1 pharmacokinetic data at nelarabine doses of 104 to 2,900 mg/m indicate that mean
Croatian: Prema podacima iz ispitivanja faze I, pri primjeni nelarabina u dozi od 104 do 2900 mg/m ara-G se široko raspodjeljuju po organizmu.
English: You (or your child, if he/she is being treated) must not receive Atriance
Croatian: Nemojte primati Atriance (odnosno Vaše dijete, ako se liječi)
English: Talk to your doctor for advice on how to minimize the risk of bleeding.
Croatian: O načinu na koji rizik od krvarenja možete svesti na najmanju moguću mjeru, porazgovarajte s Vašim liječnikom.
English: Rare: N/A
Croatian: Rijetko: nije dostupno
English: Breast-feeding must be discontinued while you are taking Atriance.
Croatian: Dok primate Atriance, dojenje se mora prekinuti.
English: (%CV) VSS values were 115 l/m
Croatian: Konkretno, kada je riječ o nelarabinu, prosječna (%CV) VSS vrijednost zabilježena u odraslih bolesnika iznosila je 115 l/m
English: Renal clearance averaged 9.0 l/h/m
Croatian: U 21 odraslog bolesnika prosječni bubrežni klirens nelarabina iznosio je 9,0 l/h/m
English: The prescribing physician should consider which regimen is appropriate when treating patients in this age range.
Croatian: Pri liječenju bolesnika ove životne dobi, odluku o tome u kojoj će dozi lijek biti primijenjen donosi nadležni liječnik koji je lijek propisao.
English: Eye disorders Blurred vision
Croatian: Poremećaji oka Zamućenje vida
English: Delaying subsequent dosing is an option for other toxicities, including haematological toxicity.
Croatian: Postoje li pokazatelji toksičnog djelovanja na druge organske sustave, uključujući krvotvorni, primjena sljedećih doza može se odgoditi.
English: Wheezing
Croatian: Omaglica
English: Novartis Pharma B.V. Tel: +31 88 04 52 555
Croatian: Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To valja imati na umu kod bolesnika u čijoj je prehrani nužno ograničiti unos natrija.
English: If you get any of the side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Hypoesthesia
Croatian: Hipokalijemija
English: Tumour size ≤ 2 cm >2 cm
Croatian: Veličina tumora 2 cm >2 cm
English: Unopened vial 2 years
Croatian: Neotvorena bočica 2 godine
English: Date of latest renewal: 23rd February 2017
Croatian: Datum posljednje obnove odobrenja: 23. veljača 2017