FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) ≥ 3.0 x 109/l and ANC ≥ 1.5 x 109/l, and platelets ≥ 75.0 x 109/l) prior to the first treatment
Croatian: Bolesnici bez smanjenih početnih vrijednosti krvne slike (tj. bijele krvne stanice ≥ 3,0 x 109/L i ABN ≥ 1,5 x 109/L i trombociti ≥ 75,0 x 109/L) prije prvog liječenja
English: Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90° angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Croatian: Rekonstituiranu Vidazu treba injicirati supkutano (iglu uvesti pod kutom od 45-90°) koristeći se iglom od 25 G u nadlakticu, bedro ili abdomen.
English: • Raised itchy rash on the skin (urticaria).
Croatian: • izbočeni osip na koži praćen svrbežom (urtikarija)
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection
Croatian: NAZIV LIJEKA Vidaza 25 mg/mL prašak za suspenziju za injekciju
English: NAME OF THE MEDICINAL PRODUCT Vidaza 25 mg/mL powder for suspension for injection Azacitidine STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains100 mg azacitidine.
Croatian: NAZIV LIJEKA Vidaza 25 mg/mL prašak za suspenziju za injekciju azacitidin NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 100 mg azacitidina.
English: The most commonly reported (≥ 30%) adverse reactions with azacitidine treatment were gastrointestinal events, including constipation (41.9%), nausea (39.8%), and diarrhoea (36.9%), (usually Grade 1-2), general disorders and administration site conditions including pyrexia (37.7%; usually Grade 1-2) and haematological events, including febrile neutropenia (32.2%) and neutropenia (30.1%), (usually Grade 3-4).
Croatian: Najčešće zabilježene (≥ 30 %) nuspojave uz liječenje azacitidinom bile su gastrointestinalni događaji, uključujući konstipaciju (41,9 %), mučninu (39,8 %) i proljev (36,9 %), (obično 1.-2. stupnja), opće poremećaje i reakcije na mjestu primjene uključujući pireksiju (37,7 %; obično 1.-2. stupnja) i hematološke događaje, koji su uključivali febrilnu neutropeniju (32,2 %) i neutropeniju (30,1 %), (obično 3.-4. stupnja).
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
Croatian: Kod bolesnika s opsežnim metastatskim tumorima, prijavljeno je zatajenje jetre, progresivna hepatička koma i smrt tijekom liječenja azacitidinom (vidjeti dio 4.4).
English: One case of overdose with azacitidine was reported during clinical trials.
Croatian: Tijekom kliničkih ispitivanja prijavljen je jedan slučaj predoziranja azacitidinom.
English: Your doctor will decide your dose of this medicine, depending on your general condition, height and weight.
Croatian: Vašem općem stanju, visini i težini.
English: Not known (frequency cannot be estimated from the available data) Infection of the deeper layers of skin, which spreads quickly, damaging the skin and tissue, which can be life-threatening (necrotizing fasciitis).
Croatian: • infekcija dubljih slojeva kože koja se bržo širi, oštećuje kožu i tkivo što može biti opasno po život (nekrotizirajući fasciitis).
English: The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20 °C-25 °C.
Croatian: Štrcaljku napunjenu rekonstituiranom suspenzijom treba ostaviti do 30 minuta prije primjene tako da dosegne temperaturu od oko 20 °C do 25 °C.
English: Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Croatian: Azacitidin je kontraindiciran u bolesnika s uznapredovalim malignim tumorima jetre (vidjeti dio 4.3).
English: You are also more likely to get infections.
Croatian: Može biti popraćeno vrućicom. također ste podložniji pojavi infekcija.
English: In animals, adverse reactions with azacitidine use on male fertility have been documented (see section 5.3).
Croatian: Zabilježeni su štetni učinci primjene azacitidina na plodnost mužjaka kod životinja (vidjeti dio 5.3).
English: The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
Croatian: Prije davanja injekcije, iz igle se ne smije ištrcavati sadržaj da bi se izbjegle reakcije na mjestu primjene.
English: Blood and lymphatic system disorders febrile neutropenia*, neutropenia, leukopenia, thrombocytopenia, anaemia pancytopenia*, bone marrow failure
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija*, neutropenija, leukopenija, trombocitopenij a, anemija pancitopenija*, zatajenje koštane srži
English: What Vidaza is
Croatian: Što je Vidaza
English: Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Croatian: Bolesnici sa smanjenim vrijednostima početne krvne slike (tj. bijele krvne stanice < 3,0 x 109/L ili ABN < 1,5 x 109/L ili trombociti < 75,0 x 109/L) prije prvog liječenja
English: You will have blood tests before you begin treatment with Vidaza and at the start of each period of treatment (called a ‘cycle').
Croatian: Prije početka liječenja Vidazom i prije početka svakog razdoblja liječenja (zvanog „ciklus“) napravit će Vam se krvne pretrage.
English: Overall response (complete remission [CR] + partial remission [PR]) as determined by the investigator was 29 % in the azacitidine group and 12% in the combined CCR group (p = 0.0001).
Croatian: Ukupni odgovor (potpuna remisija [engl. complete remission, CR] + djelomična remisija [engl. partial remission, PR]) utvrđen od istraživača bio je 29 % u skupini liječenoj azacitidinom i 12 % u kombiniranim skupinama liječenim CCR-om (p = 0,0001).
English: Subcutaneous adverse reactions such as injection site rash/inflammation/pruritus, rash, erythema and skin lesion may require management with concomitant medicinal products, such as antihistamines, corticosteroids and non-steroidal anti-inflammatory medicinal products (NSAIDs).
Croatian: Nuspojave na potkožnome tkivu poput osipa/upale/svrbeža na mjestu primjene, osipa, eritema i lezija na koži, mogu zahtijevati istodobnu primjenu lijekova poput antihistaminika, kortikosteroida i nesteroidnih protuupalnih lijekova (engl.
English: The individual baseline parameters were comparable between the Vidaza and CCR groups.
Croatian: Početni parametri pojedinih bolesnika bili su usporedivi između skupina koje su primale Vidazu i skupina koje su primale CCR.
English: Storage of the reconstituted product For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Čuvanje rekonstituiranog lijeka Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle, see also section 4.8.
Croatian: Da bi se nadzirao odgovor i toksičnost nužno je kompletnu krvnu sliku napraviti prije početka terapije i prema potrebi, ali barem prije svakog ciklusa liječenja, vidjeti također dio 4.8.
English: Subcutaneous use.
Croatian: Supkutanaprimjena.
English: • Painful skin ulceration (pyoderma gangrenosum).
Croatian: • bolni čirevi na koži (gangrenozna pioderma)
English: Hypersensitivity
Croatian: Preosjetljivost
English: It may be given under the skin on your thigh, tummy or upper arm.
Croatian: Injekcija se može davati ispod kože bedra, trbuha ili nadlaktice.
English: In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide.
Croatian: Uz to, kod 5 se bolesnika s kroničnom mijeloičnom leukemijom (KML) liječenih azacitidinom i etoposidom razvila bubrežna tubularna acidoza, definirana kao pad serumskih bikarbonata do < 20 mmol/L u kombinaciji s lužnatim urinom i hipokalemijom (serumski kalij < 3 mmol/L).
English: Overall response (CR + PR) as determined by the IRC in AZA PH GL 2003 CL 001 was 7 % (12/179) in the azacitidine group compared with 1 % (2/179) in the combined CCR group (p = 0.0113).
Croatian: Ukupni odgovor (CR + PR) koji je utvrdio IRC u AZA PH GL 2003 CL 001 bio je 7 % (12/179) u skupini liječenoj
English: Nervous system disorders dizziness, headache intracranial haemorrhage*, syncope, somnolence, lethargy
Croatian: Poremećaji živčanog sustava omaglica, glavobolja intrakranijalno krvarenje*, sinkopa, somnolencija, letargija
English: When Vidaza is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Croatian: Kada se Vidaza rekonstituira rashlađenom vodom za injekcije (2 °C do 8 °C), kemijska i fizikalna stabilnost rekonstituiranog lijeka u primjeni dokazana je pri 2 °C do 8 °C tijekom 22 sata.
English: These may be symptoms of liver failure and can be life-threatening.
Croatian: To mogu biti simptomi zatajenja jetre i mogu biti opasni za život.
English: BSA value of 1.8 m2 Number of vials required
Croatian: Ukupna doza prema vrijednosti PT-a od 1,8 m2
English: Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin < 30 g/L.
Croatian: Prijavljena je pojava progresivne hepatičke kome i smrti tijekom liječenja azacitidinom kod bolesnika s opsežnim metastatskim tumorom, osobito kod bolesnika s početnim vrijednostima serumskog albumina < 30 g/L.
English: • Large plum-coloured, raised painful patches on the skin with fever.
Croatian: • velike, tamnoljubičaste, odignute, bolne mrlje na koži s vrućicom
English: If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered.
Croatian: Ako je smanjenje vrijednosti bijelih krvnih stanica ili apsolutnog broja neutrofila ili trombocita veće od 50 % u odnosu na vrijednosti prije početka liječenja, i bez poboljšanja u diferencijaciji stanične linije, sljedeći ciklus liječenja Vidazom treba odgoditi sve dok se vrijednosti trombocita i apsolutnog broja neutrofila ne oporave.
English: Colourless type I glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button, containing 100 mg of azacitidine.
Croatian: I sa 100 mg azacitidina, zatvorena butilnim elastomernim čepom i aluminijskim prstenom s polipropilenskim plastičnim dugmetom.
English: Very common Common
Croatian: Vrlo često
English: Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 45.0 % of these patients became RBC transfusion independent during the treatment period, compared with 11.4 % of the patients in the combined CCR groups (a statistically significant (p < 0.0001) difference of 33.6 % (95 % CI: 22.4, 44.6).
Croatian: Od bolesnika u skupini liječenoj azacitidinom koji su na početku bili ovisni o transfuziji eritrocita, tijekom liječenja ih je 45 % postalo neovisno o transfuziji eritrocita, u usporedbi s 11,4 % bolesnika u kombiniranim skupinama liječenih CCR-om, te je razlika i statistički značajna (p < 0,0001) od 33,6 % (95 % CI: 22,4, 44,6).
English: The most commonly reported adverse reactions with azacitidine treatment were haematological reactions (71.4 %) including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events (60.6 %) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
Croatian: Najčešće prijavljene nuspojave kod liječenja azacitidinom bile su hematološke reakcije (71,4 %), uključujući trombocitopeniju, neutropeniju i leukopeniju (najčešće 3.-4. stupnja), gastrointestinalne smetnje (60,6 %) uključujući mučninu, povraćanje (najčešće 1.-2. stupnja) ili reakcije na mjestu primjene (77,1 %; najčešće 1.-2. stupnja).
English: • White coating covering tongue, inner cheeks, and sometimes on the roof of your mouth, gums and tonsils (oral fungal infection).
Croatian: • bijelim naslagama obložen jezik, unutarnje strane obraza i ponekad nepce, desni i tonzile
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: • Constipation, diarrhoea, nausea, vomiting.
Croatian: • zatvor, proljev, mučnina, povraćanje
English: The syringe with needle should then be removed from the vial and the needle disposed of.
Croatian: Štrcaljku s iglom treba ukloniti iz bočice te iglu zbrinuti.
English: In all pre- specified subgroups age [(< 75 years & ≥ 75 years), gender, race, ECOG performance status (0 or 1 & 2) , baseline cytogenetic risk (intermediate & poor) , geographic region, WHO classification of AML (including AML with myelodysplasia-related changes), baseline WBC count (≤ 5 x109/L & >5 x 109/L), baseline bone marrow blasts (≤ 50% & > 50%) and prior history of MDS] there was a trend in OS benefit in favour of Vidaza.
Croatian: Trend koristi za ukupno preživljenje išao je u prilog Vidazi u svim unaprijed određenim podskupinama po dobi [(< 75 godina i ≥ 75 godina), spolu, rasi, ECOG funkcionalnom statusu (0 ili 1 i 2) , početnom citogenetskom riziku (srednji i visoki), geografskoj regiji, klasifikaciji AML-a prema SZO-u (uključujući AML s promjenama povezanim s mijelodisplazijom), početnom broju bijelih krvnih stanica (≤ 5 x 109/L i >5 x 109/L), blastima u koštanoj srži na početku (≤ 50 % i > 50 %) i prethodnom MDS-u u anamnezi].
English: Unopened vials This medicinal product does not require any special storage conditions.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja.
English: • Pneumonia.
Croatian: • upala pluća
English: gastrointestinal haemorrhage* (includes mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia
Croatian: gastrointestinaln o krvarenje* (uključuje krvarenje u ustima), krvarenje iz hemoroida, stomatitis, krvarenje iz gingiva, dispepsija
English: Reconstituted Vidaza should be injected subcutaneously into the upper arm, thigh or abdomen.
Croatian: Rekonstituiranu Vidazu treba injicirati supkutano u nadlakticu, bedro ili abdomen.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Celgene Europe B.V.
English: • Drowsiness, shaking, jaundice, abdominal bloating and easy bruising.
Croatian: • Omamljenost, tresavicu, žuticu, nadimanje u trbuhu i lako nastajanje modrica.
English: After reconstitution each mL of suspension will contain 25 mg of azacitidine (100 mg/4 mL).
Croatian: Nakon rekonstitucije svaki mL suspenzije sadrži 25 mg azacitidina (100 mg/4 mL).
English: If it comes into contact with mucous membranes, flush thoroughly with water.
Croatian: Ako dođe u dodir sa sluznicama, treba ih dobro isprati vodom.
English: Patients with hepatic impairment
Croatian: Bolesnici s oštećenjem bubrega
English: Pharmacogenomics
Croatian: Farmakogenomika
English: What Vidaza looks like and contents of the pack Vidaza is a white powder for suspension for injection and is supplied in a glass vial containing 100 mg of azacitidine.
Croatian: Vidaza je bijeli prašak za suspenziju za injekciju pohranjen u staklenoj bočici koja sadrži 100 mg azacitidina.
English: Recovery* > 21 days *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Following dose modifications, the cycle duration should return to 28 days.
Croatian: ≥ najniža vrijednost + (0,5 x [početna vrijednost - najniža vrijednost]) Nakon izmjena doze, trajanje ciklusa ponovno treba biti 28 dana.
English: Serious hypersensitivity reactions have been reported in patients receiving azacitidine.
Croatian: Kod bolesnika liječenih azacitidinom prijavljene su ozbiljne reakcije preosjetljivosti.
English: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International
Croatian: • mijelodisplastičnih sindroma (MDS) srednjeg 2 i visokog rizika prema međunarodnom prognostičkom numeričkom sustavu rangiranja (engl.
English: In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the Vidaza group and 19.2 months in the CCR group.
Croatian: U bolesnika koji su na početku bili ovisni o transfuzijama trombocita i postigli neovisnost o transfuzijama uz liječenje, medijan trajanja neovisnosti o transfuzijama trombocita bio je 10,8 mjeseci u skupini liječenoj Vidazom i 19,2 mjeseca u skupini liječenoj CCR-om.
English: In a few pre-specified subgroups, the OS HR reached statistical significance including patients with poor cytogenetic risk, patients with AML with myelodysplasia-related changes, patients < 75 years, female patients and white patients.
Croatian: Omjer hazarda ukupnog preživljenja dostigao je statističku značajnost u nekoliko unaprijed određenih podskupina uključujući bolesnike s visokim citogenetskim rizikom, bolesnike s AML-om s promjenama povezanim s mijelodisplazijom, bolesnike u dobi
English: Respiratory, thoracic and mediastinal disorders dyspnoea, epistaxis pleural effusion, dyspnoea exertional, pharyngolaryngeal pain interstitial lung disease
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, epistaksa pleuralni izljev, dispneja u naporu, faringolaringeal na bol intersticijsk a bolest pluća
English: Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Croatian: KLINIČKI PODACI 4.1 Terapijske indikacije Vidaza je indicirana za liječenje odraslih bolesnika koji nisu zadovoljavali kriterije za transplantaciju hematopoetskih matičnih stanica (THMS), koji boluju od:
English: How Vidaza works
Croatian: Kako Vidaza djeluje
English: In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the Vidaza group and was not reached in the CCR group.
Croatian: U bolesnika koji su ovisili o transfuzijama eritrocita na početku i postigli neovisnost o transfuzijama uz liječenje, medijan trajanja neovisnosti o transfuzijama eritrocita iznosio je 13,9 mjeseci u skupini koja je primala Vidazu i nije bio postignut u skupini koja je primala CCR.
English: A patient was considered RBC or platelet transfusion independent during the treatment period if the subject had no RBC or platelet transfusions during any consecutive 56 days during the reporting period, respectively.
Croatian: CCR Azacitidin eritrocita ili trombocita tijekom razdoblja liječenja ako taj ispitanik nije primio transfuziju eritrocita odnosno trombocita tijekom bilo kojih uzastopnih 56 dana tijekom razdoblja izvjšćivanja.
English: In patients who achieved CR or CRi, the median duration of remission was 10.4 months (95% CI = 7.2, 15.2) for the Vidaza subjects and 12.3 months (95% CI = 9.0, 17.0) for the CCR subjects.
Croatian: U bolesnika koji su postigli potpunu remisiju ili potpunu remisjiju s nepotpunim oporavkom krvne slike, medijan trajanja remisije iznosio je 10,4 mjeseca (95 % CI = 7,2; 15,2) u ispitanika liječenih Vidazom i 12,3 mjeseca (95 % CI = 9,0; 17,0) u ispitanika liječenih CCR-om.
English: Musculoskeletal and connective tissue disorders arthralgia, musculoskeletal pain (includes back, bone and pain in extremity)
Croatian: Poremećaji mišićno-koštano g sustava i vezivnog tkiva artralgija, mišićno-koštana bol (uključuje bol u leđima, kostima i udovima)
English: bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule and haemorrhage (at injection site), malaise, chills, catheter site hemorrhage injection site necrosis (at injection site)
Croatian: modrica, hematom, otvrdnuće, osip, svrbež, upala, diskoloracija, čvorić i krvarenje (na mjestu primjene), malaksalost, zimica, krvarenje na mjestu katetera nekroza na mjestu primjene (na mjestu primjene)
English: The survival benefits of Vidaza were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
Croatian: Dobrobit od Vidaze za vrijeme preživljenja bila je konzistentna bez obzira na vrstu liječenja primijenjenu u kontrolnoj skupini tijekom liječenja CCR-om (samo BSC-om, niske doze citarabina s BSC-om ili standardna indukcijska kemoterapija s BSC-om).
English: Bleeding
Croatian: Krvarenje
English: • Sore nose and throat.
Croatian: • bol u nosu i grlu
English: Rare side effects (may affect up to 1 in 1,000 people)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba)
English: • higher-risk myelodysplastic syndromes (MDS).
Croatian: • mijelodisplastičnih sindroma (MDS) visokog rizika
English: Deaths: AZA = 82, CCR = 113
Croatian: HR = 0,58 [95% CI: 0,43 - 0,77] Smrtnost: AZA = 82, CCR = 113
English: • Lethargy.
Croatian: • letargija
English: Of the patients in the Vidaza group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Croatian: Od bolesnika u skupini liječenoj Vidazom koji su na početku bili ovisni o transfuziji eritrocita, 38,5 % (95 % CI = 31,1; 46,2) postalo je neovisno o transfuzijama eritrocita tijekom razdoblja liječenja u usporedbi s 27,6 % (95 % CI = 20,9; 35,1) bolesnika u kombiniranim skupinama liječenima CCR-om.
English: If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
Croatian: Ako je od rekonstitucije proteklo više od 45 minuta, rekonstituiranu suspenziju treba primjereno baciti i pripremiti novu dozu.
English: • Low levels of potassium in your blood.
Croatian: • niske razine kalija u krvi
English: Serious adverse reactions such as sepsis, including neutropenic sepsis, and pneumonia were reported in patients receiving azacitidine, some with a fatal outcome.
Croatian: Kod bolesnika koji su primali azacitidin prijavljene su ozbiljne nuspojave poput sepse, uključujući neutropeničnu sepsu i pneumoniju, od kojih su neke imale smrtni ishod.
English: Of the patients in the Vidaza group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Croatian: Od bolesnika u skupini liječenoj Vidazom koji su na početku bili ovisni o transfuziji trombocita, 40,6 % (95 % CI = 30,9; 50,8) postalo je neovisno o transfuziji trombocita tijekom razdoblja liječenja u usporedbi s 29,3 % (95 % CI = 19,7, 40,4) bolesnika u kombiniranim skupinama liječenima CCR-om.
English: • Collection of fluid around the heart (pericardial effusion)..
Croatian: • Nakupljanje tekućine oko srca (perikardijalni izljev)
English: These may be symptoms of kidney failure and can be life-threatening.
Croatian: To mogu biti simptomi zatajenja bubrega i mogu biti opasni za život.
English: Vial(s) of azacitidine; vial(s) of water for injections; non-sterile surgical gloves; alcohol wipes; 5 mL injection syringe(s) with needle(s).
Croatian: Potrebno je pripremiti sljedeći pribor: bočicu (bočice) azacitidina; bočicu (bočice) vode za injekcije; nesterilne kirurške rukavice; maramice natopljene alkoholom; štrcaljku (štrcaljke) od 5 mL s iglom (iglama).
English: If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
Croatian: Ako je od pohrane u hladnjak proteklo više od 8 sati, suspenziju treba primjereno odbaciti i pripremiti novu dozu.