FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents.
Croatian: Prijavljene su bubrežne abnormalnosti u rasponu od povišenog serumskog kreatinina do zatajenja bubrega i smrti kod bolesnika liječenih intravenskim azacitidinom u kombinaciji s drugim kemoterapijskim lijekovima.
English: At baseline 60.7% were classified as AML not otherwise specified, 32.4% AML with myelodysplasia-related changes, 4.1% therapy-related myeloid neoplasms and 2.9% AML with recurrent genetic abnormalities according to the WHO classification.
Croatian: Na početku je njih 60,7 % bilo kategorizirano kao AML koja nije dodatno klasificirana, 32,4 % kao AML s promjena povezanim s mijelodisplazijoma, 4,1 % kao mijeloidne novotvorine povezane s terapijom te 2,9 % kao AML s recidivirajućim genetskim abnormalnostima prema klasifikaciji SZO-a.
English: Shake the suspension vigorously before administration.
Croatian: Prije primjene snažno protresite suspenziju.
English: Cardiac disorders pericardial effusion pericarditis
Croatian: Srčani poremećaji perikardijalni izljev perikarditis
English: Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs); interactions related to these metabolizing enzymes in vivo are therefore considered unlikely.
Croatian: Na temelju podataka in vitro, čini se da metabolizam azacitidina nije posredovan izoenzimima citokroma P450 (CYP), UDP-glukuronil transferazama (UGT), sulfotransferazama (SULT) i glutation transferazama (GST); stoga se smatra da interakcije povezane s tim metabolizirajućim enzimima in vivo nisu vjerojatne.
English: • Fluid around the lungs (pleural effusion).
Croatian: • tekućina oko pluća (pleuralni izljev)
English: If unexplained reductions in serum bicarbonate levels to less than 20 mmol/l occur, the dose should be reduced by 50 % on the next cycle.
Croatian: Ako dođe do neobjašnjenog smanjenja razine bikarbonata u serumu ispod 20 mmol/L, u sljedećem ciklusu dozu treba smanjiti za 50 %.
English: • Bleeding gums, bleeding in the stomach or gut, bleeding from around your back passage due to piles (haemorrhoidal haemorrhage), bleeding in your eye, bleeding under your skin, or into your skin (haematoma).
Croatian: • krvarenje desni, krvarenje u želucu ili crijevima, krvarenje iz izlaznog dijela debelog crijeva zbog hemoroida (hemoroidalno krvarenje), krvarenje u oku, krvarenje ispod kože ili u kožu
English: The needle of the syringe containing the 4 mL of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
Croatian: Iglu štrcaljke s 4 mL vode za injekcije treba ubosti kroz gumeni čep na vrhu bočice azacitidina te ubrizgati vodu za injekcije u bočicu.
English: • chronic myelomonocytic leukaemia (CMML).
Croatian: • kronične mijelomonocitne leukemije (KMML)
English: Haematological improvement (major or minor) as determined by the IRC was achieved in 49 % of patients receiving azacitidine compared with 29 % of patients treated with combined CCR (p < 0.0001).
Croatian: Hematološko poboljšanje (veće ili manje) koje je ustanovio IRC postignuto je kod 49 % bolesnika koji su primali azacitidin u odnosu na 29 % bolesnika koji su liječeni kombinirano CCR-om (p < 0,0001).
English: • Difficulty breathing, swelling of the lips, itching or rash.
Croatian: • Otežano disanje, oticanje usana, svrbež ili osip.
English: These may be symptoms of having low levels of platelets in your blood.
Croatian: To mogu biti simptomi niskog broja krvnih pločica u krvi.
English: • Reduced white blood cell count.
Croatian: • smanjen broj bijelih krvnih stanica.
English: Metabolism and nutrition disorders anorexia, decreased appetite, hypokalemia dehydration tumour lysis syndrome
Croatian: Poremećaji metabolizma i prehrane anoreksija, smanjeni apetit, hipokalemija dehidracija sindrom lize tumora
English: The suspension should be allowed up to 30 minutes prior to administration to reach room temperature (20 °C - 25 °C).
Croatian: Prije primjene suspenziju treba ostaviti stajati do 30 minuta, tako da dosegne sobnu temperaturu (20 °C do 25 °C).
English: When Vidaza is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25 °C for 45 minutes and at 2 °C to 8 °C for 8 hours.
Croatian: Kada se Vidaza rekonstituira vodom za injekcije koja nije bila rashlađena, kemijska i fizikalna stabilnost rekonstituiranog lijeka u primjeni dokazana je pri 25 °C tijekom 45 minuta i pri 2 °C do 8 °C tijekom 8 sati.
English: Vidaza therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated.
Croatian: U bolesnika koji razviju nekrotizirajući fasciitis, terapiju Vidazom treba prekinuti i brzo započeti odgovarajuće liječenje.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p < 0.0001).
Croatian: Stopa dvogodišnjeg preživljenja kod bolesnika liječenih azacitidinom je bila 50,8 % naspram 26,2 % kod bolesnika liječenih CCR-om (p < 0,0001).
English: Vidaza was administered at a subcutaneous dose of 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle) for a median of 9 cycles (range = 1-39) and a mean of 10.2 cycles.
Croatian: Vidaza se primjenjivala supkutano u dozi od 75 mg/m2 dnevno tijekom 7 dana, zatim je slijedilo razdoblje odmora od 21 dana (28-dnevni ciklus liječenja) za medijan od 9 ciklusa (raspon = 1-39) i prosjek od 10,2 ciklusa.
English: No formal studies have been conducted in patients with hepatic impairment (see section 4.4).
Croatian: Nisu provedena službena ispitivanja kod bolesnika s oštećenjem jetre (vidjeti dio 4.4).
English: Cardiac and pulmonary disease
Croatian: Srčane i plućne bolesti
English: Complete blood counts should be performed as needed to monitor response and toxicity, but at least prior to each treatment cycle.
Croatian: Kompletnu krvnu sliku treba napraviti kad je potrebno da bi se pratio odgovor i toksičnost, ali najmanje prije svakog ciklusa liječenja.
English: Infections may be managed with the use of antiinfectives plus growth factor support (e.g. G-CSF) for neutropenia.
Croatian: Infekcije se mogu suzbiti primjenom antimikrobnih lijekova i stimulirajućeg čimbenika rasta (npr. G-CSF) kod neutropenije.
English: Overall response rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]) as determined by the IRC was 27.8% in the Vidaza group and 25.1% in the combined CCR group (p = 0.5384).
Croatian: Stopa ukupnog odgovora (potpuna remisija [CR] + potpuna remisija s nepotpunim oporavkom krvne slike [CRi]) kako je utvrdio IRC bila je 27,8 % u skupini liječenoj Vidazom i 25,1 % kombiniranoj skupini liječenoj CCR-om (p = 0,5384).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than 8 hours at 2 °C to 8 °C when reconstituted using water for injections that has not been refrigerated or not longer than 22 hours when reconstituted using refrigerated (2 °C to 8 °C) water for injections.
Croatian: Ako se ne upotrijebi odmah, za vrijeme i uvjete čuvanja prije uporabe odgovoran je korisnik, te vrijeme čuvanja ne smije biti dulje od 8 sati pri 2 °C do 8 °C kada se za rekonstituciju upotrebljava voda za injekcije koja nije bila rashlađena ili ne dulje od 22 sata kada se za rekonstituciju upotrebljava rashlađena voda za injekcije (2 °C do 8 °C).
English: Infections and infestations pneumonia* (including bacterial, viral and fungal), nasopharyngitis sepsis* (including bacterial, viral and fungal), neutropenic sepsis*, respiratory tract infection (includes upper and bronchitis), urinary tract infection, cellulitis, diverticulitis, oral fungal infection, sinusitis, pharyngitis, rhinitis, herpes simplex, skin infection necrotising fasciitis *
Croatian: Infekcije i infestacije pneumonija* (uključujući bakterijsku, virusnu i gljivičnu), nazofaringitis sepsa* (uključujući bakterijsku, virusnu i gljivičnu), neutropenična sepsa*, infekcija dišnih puteva (uključuje gornje dišne puteve i bronhitis), infekcija mokraćnih puteva, celulitis, divertikulitis, oralna gljivična infekcija, sinusitis, faringitis, rinitis, herpes simplex, kožna infekcija nekrotiziraju ći fasciitis*
English: Men should be advised not to father a child while receiving treatment and must use effective contraception during and up to 3 months after treatment.
Croatian: Muškarce treba upozoriti da ne bi smjeli začeti dijete tijekom liječenja te da za vrijeme liječenja i do 3 mjeseca nakon njega moraju primjenjivati učinkovitu kontracepciju.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: • Painless swelling in the finger tips (clubbing).
Croatian: • bezbolno oticanje jagodica prstiju (batićasti prsti)
English: Other serious adverse reactions from these 3 studies included infections such as neutropenic sepsis (0.8%) and pneumonia (2.5%) (some with fatal outcome), thrombocytopenia (3.5%), hypersensitivity reactions (0.25%) and haemorrhagic events (e.g. cerebral haemorrhage [0.5%], gastrointestinal haemorrhage [0.8%] and intracranial haemorrhage
Croatian: Druge ozbiljne nuspojave iz ta 3 ispitivanja uključivale su infekcije kao što su neutropenijska sepsa (0,8 %) i pneumonija (2,5 %) (neke sa smrtnim ishodom), trombocitopeniju (3,5 %), reakcije preosjetljivosti (0,25 %) i hemoragijske događaje (npr. moždano krvarenje [0,5 %], gastrointestinalno krvarenje [0,8 %] i intrakranijalno krvarenje [0,5 %]).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene od težih prema manje teškima.
English: In rats, azacitidine caused no adverse reactions when given preimplantation, but it was clearly embryotoxic when given during organogenesis.
Croatian: Kod štakora, azacitidin primijenjen prije implantacije embrija nije prouzročio nuspojave ali je, primijenjen tijekom organogeneze, bio nedvojbeno embriotoksičan.
English: A patient was considered RBC or platelet transfusion dependent at baseline if the subject had one or more RBC or platelet transfusions during the 56 days (8 weeks) on or prior to randomization, respectively.
Croatian: Smatralo se da je bolesnik ovisan o transfuzijama eritrocita odnosno trombocita na početku ako je taj ispitanik primio jednu ili više transfuzija eritrocita ili trombocita tijekom 56 dana (8 tjedana) prilikom odnosno prije randomizacije.
English: Patients received the pre-selected regimen if not randomised to Vidaza.
Croatian: Bolesnici su primili unaprijed odabrani režim ako nisu bili randomizirani u skupinu koja prima Vidazu.
English: Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro.
Croatian: In vitro azacitidin inducira genske mutacije i kromosomske aberacije u staničnim sustavima bakterija i sisavaca.
English: Vidaza was administered at a SC dose of 75mg/m2/day for 7 days, followed by a rest period of 21 days (28 day treatment cycle), for a median of 6 cycles (range: 1 to 28), BSC- only patients for a median of 3 cycles (range: 1 to 20), low-dose cytarabine patients for a median of 4 cycles (range 1 to 25) and standard intensive chemotherapy patients for a median of 2 cycles (range: 1 to 3, induction cycle plus 1 or 2 consolidation cycles).
Croatian: Vidaza se primjenjivala s.c. u dozi od 75 mg/m2 na dan tijekom 7 dana, nakon čega je slijedila stanka od uzimanja lijeka od 21 dan (ciklus liječenja od 28 dana), tijekom medijana od 6 ciklusa (raspon: od 1 do 28), bolesnici koji su primali samo BSC tijekom medijana od 3 ciklusa (raspon: od 1 do 20), bolesnici koji su primali nisku dozu citarabina tijekom medijana od 4 ciklusa (raspon: od 1 do 25) i bolesnici koji su primali standardnu intenzivnu kemoterapiju tijekom medijana od 2 ciklusa (raspon: od 1 do 3, uvodni ciklus plus 1 ili 2 konsolidacijska ciklusa).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE
English: • A viral infection causing cold sores (herpes).
Croatian: • virusna infekcija koja uzrokuje herpes
English: Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs).
Croatian: Na temelju in vitro podataka, čini se da metabolizam azacitidina nije posredovan izoenzimima citokroma P450 (CYP), UDP-glukuronil transferazama (UGT), sulfotransferazama (SULT) i glutation transferazama (GST).
English: CCR consisted of BSC alone (n=45), lowdose cytarabine plus BSC (n=158), or standard intensive chemotherapy with cytarabine and anthracycline plus BSC (n=44).
Croatian: CCR se sastojao od samo BSC-a (n = 45), niske doze citarabina uz BSC (n = 158) ili standardne intenzivne kemoterapije citarabinom i antraciklinom uz BSC (n = 44).
English: These adverse reactions were managed symptomatically with anti-emetics for nausea and vomiting; anti-diarrhoeals for diarrhoea, and laxatives and/or stool softeners for constipation.
Croatian: Te su nuspojave liječene simptomatski, antiemeticima za mučninu i povraćanje; antidijaroicima za proljev i laksativima i/ili tvarima koje omekšavaju stolicu za konstipaciju.
English: The most commonly reported (≥ 10%) haematological adverse reactions associated with azacitidine treatment include anaemia, thrombocytopenia, neutropenia, febrile neutropenia and leukopenia, and were usually Grade 3 or 4.
Croatian: Najčešće prijavljene (≥ 10 %) hematološke nuspojave povezane s liječenjem azacitidinom uključuju anemiju, trombocitopeniju, neutropeniju, febrilnu neutropeniju i leukopeniju, te su obično bile 3. i 4. stupnja.
English: In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), Vidaza treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001.
Croatian: U ITT analizi 358 bolesnika (179 s azacitidinom i 179 s CCR-om) liječenje Vidazom bilo je povezano s medijanom preživljenja od 24,46 mjeseci naspram 15,02 mjeseci kod bolesnika liječenih CCR-om, razlika od 9,4 mjeseci sa stratificiranom log-rang p-vrijednošću od 0,0001.
English: You should not breast-feed when using Vidaza.
Croatian: Ne smijete dojiti za vrijeme primjene Vidaze.
English: Use an effective method of contraception during and up to 3 months after treatment with this medicine.
Croatian: Koristite učinkovitu kontracepcijsku zaštitu tijekom liječenja i do 3 mjeseca nakon liječenja ovim lijekom.
English: Skin and subcutaneous tissue disorders petechiae, pruritus (includes generalized), rash, ecchymosis purpura, alopecia, urticaria, erythema, rash macular acute febrile neutrophilic dermatosis, pyoderma gangrenosum
Croatian: Poremećaji kože i potkožnog tkiva petehije, svrbež (uključuje generalizirani), osip, ekhimoze purpura, alopecija, urtikarija, eritem, makularni osip akutna febrilna neutrofilna dermatoza, gangrenozna pioderma
English: Blood test
Croatian: Krvne pretrage
English: Foetal abnormalities during organogenesis in rats included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly) and others (microphthalmia, micrognathia, gastroschisis, oedema, and rib abnormalities).
Croatian: Fetalne abnormalnosti prouzročene u štakora tijekom organogeneze uključuju: anomalije središnjega živčanog sustava (egzencefalija/encefalokela), anomalije udova (mikromelija, ekvinovarus stopala, sindaktilija, oligodaktilija) i druge (mikrooftalmija, mikrognatija, gastroshiza, edem i abnormalnosti rebara).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vidaza 25 mg/mL powder for suspension for injection Azacitidine Subcutaneous use METHOD OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vidaza 25 mg/mL prašak za suspenziju za injekciju azacitidin Supkutana primjena NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: 2 vials
Croatian: 2 bočice
English: • A disease affecting the gut which can result in fever, vomiting and stomach pain (diverticulitis).
Croatian: • bolest koja zahvaća crijeva što može dovesti do vrućice, povraćanja i bolova u trbuhu
English: Gastrointestinal adverse reactions
Croatian: Gastrointestinalne nuspojave
English: If haematological toxicity is observed following Vidaza treatment, the next cycle of the therapy should be delayed until the platelet count and the ANC have recovered.
Croatian: Ako se nakon liječenja Vidazom opazi hematološka toksičnost, sljedeći ciklus liječenja treba odgoditi sve dok se ne oporave vrijednosti trombocita i apsolutnog broja neutrofila.
English: CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25).
Croatian: CCR se sastojao samo od BSC-a (n = 105), niske doze citarabina s BSC-om (n = 49) ili standardne indukcijske kemoterapije s BSC-om (n = 25).
English: Proportion Surviving
Croatian: Vjerojatnost preživljenja
English: Storage of the reconstituted product
Croatian: Čuvanje rekonstituiranog lijeka
English: Adult population with MDS, CMML and AML (20-30% marrow blasts)
Croatian: Odrasla populacija s MDS-om, KMML-om i AML-om (20-30 % blasta u koštanoj srži)
English: Vascular disorders hypotension*, hypertension, orthostatic hypotension, haematoma
Croatian: Krvožilni poremećaji hipotenzija*, hipertenzija, ortostatska hipotenzija, hematom
English: Recent data from a clinical trial in patients with a known history of cardiovascular or pulmonary disease showed a significantly increased incidence of cardiac events with azacitidine (see section 4.8).
Croatian: Noviji podaci iz kliničkog ispitivanja u bolesnika s kardiovaskularnom ili plućnom bolešću u povijesti bolesti pokazali su značajno povišenu incidenciju srčanih događaja uz azacitidin (vidjeti dio 4.8).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
English: ANC (x 109/l)
Croatian: Apsolutni broj neutrofila (x 109/L)
English: Bleeding may occur with patients receiving azacitidine.
Croatian: Kod bolesnika koji primaju azacitidin može se javiti krvarenje.
English: Data from a clinical trial allowing enrolment of patients with known history of cardiovascular or pulmonary disease showed a statistically significant increase in cardiac events in patients with newly diagnosed AML treated with azacitidine (see section 4.4).
Croatian: Podaci iz jednog kliničkog ispitivanja koje je dopustilo uključivanje bolesnika s kardiovaskularnom ili plućnom bolešću u povijesti bolesti pokazali su statistički značajno povećanje srčanih događaja u bolesnika s novodijagnosticiranom AML koji su bili liječeni azacitidinom (vidjeti dio 4.4).
English: Other less frequently reported serious adverse reactions in the azacitidine treatment arm included sepsis (5.1%), anaemia (4.2%), neutropenic sepsis (3.0%), urinary tract infection (3.0%), thrombocytopenia (2.5%), neutropenia (2.1%), cellulitis (2.1%), dizziness (2.1%) and dyspnoea (2.1%).
Croatian: Druge manje često zabilježene ozbiljne nuspojave u skupini liječenoj azacitidinom uključivale su sepsu (5,1 %), anemiju (4,2 %), neutropenijsku sepsu (3,0 %), infekciju mokraćnog sustava (3,0 %), trombocitopeniju (2,5 %), neutropeniju (2,1 %), celulitis (2,1 %), omaglicu (2,1 %) i dispneju (2,1 %).
English: Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA.
Croatian: Pretpostavlja se da azacitidin ispoljava protutumorsko djelovanje brojnim mehanizmima koji uključuju citotoksičnost prema abnormalnim hematopoetskim stanicama u koštanoj srži i hipometilaciju DNK-a.
English: In the ITT analysis of 488 patients (241 Vidaza and 247 CCR), Vidaza treatment was associated with a median survival of 10.4 months versus 6.5 months for those receiving CCR treatment, a difference of 3.8 months, with a stratified log-rank p-value of 0.1009 (two- sided).
Croatian: U ITT analizi 488 bolesnika (od kojih je 241 primao Vidazu, a njih 247 primalo je CCR), liječenje Vidazom bilo je povezano s medijanom preživljenja od 10,4 mjeseca naspram 6,5 mjeseci za one koji su primali liječenje CCR-om, što je razlika od 3,8 mjeseci, uz stratificiranu log-rang p-vrijednost od 0,1009 (dvostrana).
English: 1 vial - 100 mg METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: 1 bočica - 100 mg NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: What Vidaza is used for
Croatian: Za što se Vidaza koristi
English: Gastrointestinal disorders diarrhoea, vomiting, constipation, nausea, abdominal pain (includes upper and abdominal discomfort)
Croatian: Poremećaji probavnog sustava proljev, povraćanje, konstipacija, mučnina, bol u abdomenu (uključuje nelagodu u gornjem dijelu i abdominalnu nelagodu)
English: • A fever.
Croatian: • Vrućica.
English: • Pain in your throat and voicebox.
Croatian: • bol u grlu i glasnicama
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Croatian: CHMP predlaže izmjenu uvjeta odobrenja za stavljanje lijeka u promet.
English: Vidaza treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Croatian: Liječenje Vidazom smanjilo je potrebu za transfuzijom crvenih krvnih stanica i trombocita.
English: The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2 °C to 8 °C) water for injections.
Croatian: Rok valjanosti rekonstituiranog lijeka može se produljiti rekonstitucijom rashlađenom vodom za injekcije (2 °C do 8 °C).
English: Vidaza is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Croatian: Vidaza je kontraindicirana u bolesnika s uznapredovalim malignim tumorima jetre (vidjeti dijelove 4.3 i 4.4).
English: • Blood in your urine.
Croatian: • krv u mokraći
English: • Dry cough.
Croatian: • suhi kašalj
English: This may be due to low levels of white cells in your blood.
Croatian: Može nastati zbog niskih razina bijelih krvnih stanica u krvi.
English: Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i.e. blood count at recovery ≥ nadir count + (0.5 x [baseline count - nadir count]).
Croatian: Oporavak je definiran kao porast staničnih linija kod kojih je uočena hematološka toksičnost, i to najmanje za polovinu razlike najniže i početne vrijednosti, uvećanu za najnižu vrijednost (tj. krvna slika u oporavku ≥ najniža vrijednost + (0,5 x [početna vrijednost - najniža vrijednost]).
English: Use an effective method of contraception during and up to 3 months after treatment.
Croatian: Koristite učinkovitu kontracepcijsku zaštitu tijekom liječenja i do 3 mjeseca nakon liječenja.