FrancophonIA/ELRC3.0 huggingface dataset:
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists (see section 4.4).
Croatian: Romiplostim se ne smije primjenjivati u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh zbroj ≥ 7) osim u slučaju kada je očekivana korist veća od identificiranog rizika nastanka tromboze vene porte u bolesnika s trombocitopenijom povezanom s insuficijencijom jetre liječenih agonistima trombopoetina (TPO) (vidjeti dio 4.4).
English: Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Croatian: Povećanje količine retikulina u koštanoj srži može nastati zbog stimulacije TPO receptora, što dovodi do povećanja broja megakariocita u koštanoj srži te mogućeg naknadnog otpuštanja citokina.
English: Left over Nplate in vial must NEVER be re-used for another injection.
Croatian: Preostali Nplate u bočici NE SMIJE se ponovno uporabiti za drugu injekciju.
English: Studies in animals have shown that romiplostim crossed the placenta and increased foetal platelet counts.
Croatian: Ispitivanja na životinjama su pokazala da ramiplostim prolazi kroz placentu te uzrokuje povišenje broja trombocita u fetusa.
English: Nplate's active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Croatian: Nplate je romiplostim, protein koji se koristi za liječenje sniženog broja trombocita u bolesnika s imunološkom (idiopatskom) trombocitopeničnom purpurom (skraćeno ITP).
English: No adverse effects were seen in rats given a single dose of 1,000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, respectively).
Croatian: Nisu primijećeni nikakvi štetni učinci na štakore kojima je dana jedna doza od 1000 µg/kg ili na majmune nakon opetovane primjene romiplostima u dozi 500 µg/kg (što je 100 ili 50 puta veća doza od maksimalne kliničke doze od 10 µg/kg).
English: > 150 for two consecutive weeks
Croatian: > 150 tijekom dva uzastopna tjedna Smanjiti tjednu dozu za 1 µg/kg
English: Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim.
Croatian: Bolesnike se mora pomno pratiti zbog mogućeg smanjenja broja trombocita i primijeniti terapijske mjere kako bi se izbjeglo krvarenje u slučaju prekida terapije romiplostimom.
English: * see section 4.4 ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema *** Additional adverse reactions observed in paediatric studies
Croatian: * vidjeti dio 4.4 ** Reakcije preosjetljivosti uključujući slučajeve osipa, urtikarije i angioedema *** Dodatne nuspojave primijećene u ispitivanjima u pedijatrijskih bolesnika
English: 4 alcohol swabs.
Croatian: 4 vatice natopljene alkoholom.
English: Eye disorder
Croatian: Poremećaji oka
English: Do not over tighten.
Croatian: Nemojte ga previše zategnuti.
English: Water for injections should be injected into the vial.
Croatian: Voda za injekcije ubrizgava se u bočicu.
English: Initial reconstitution of romiplostim with designated volumes of sterile water for injections results in a concentration of 500 mcg/mL in all vial sizes.
Croatian: Inicijalnom rekonstitucijom romiplostima s naznačenim volumenima sterilne vode za injekcije dobiva se koncentracija od 500 µg/ml u svim veličinama bočica.
English: • Do not pull the plunger out of the back of the syringe.
Croatian: • Nemojte izvući klip iz štrcaljke.
English: Platelet counts should be assessed monthly thereafter.
Croatian: Nakon toga se broj trombocita mora kontrolirati jednom mjesečno.
English: In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
Croatian: U placebo skupini, zadovoljavajući porast broja trombocita zabilježen je kod 0% do 7% bolesnika tijekom šestomjesečnog liječenja.
English: • pain in your hands and feet;
Croatian: • bol u šakama i stopalima;
English: Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim.
Croatian: Vjerojatno je da će se trombocitopenija ponovno pojaviti nakon prekida terapije romiplostimom.
English: In study S5, 22 subjects were randomised in a 3:1 ratio to receive romiplostim (n = 17) or placebo (n = 5).
Croatian: U ispitivanju S5, 22 bolesnika bila su randomizirana u omjeru 3:1 za primanje romiplostima (n = 17) ili placeba (n = 5).
English: • Do not touch the top of vial adapter.
Croatian: • Nemojte dodirivati vrh nastavka za bočicu.
English: This medicine may be removed from the refrigerator for a period of 30 days at room temperature (up to 25ºC) when stored in the original carton.
Croatian: Ovaj lijek se može izvaditi iz hladnjaka i čuvati na sobnoj temperaturi (do 25ºC) tijekom 30 dana, ako se čuva u originalnom pakiranju.
English: Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications.
Croatian: Predoziranje može uzrokovati veliko povećanje broja trombocita povezano s trombotičkim/tromboembolijskim komplikacijama.
English: The individual patient dose = 75 kg x 1 mcg/kg = 75 mcg
Croatian: Individualna doza za tog bolesnika = 75 kg x 1 µg/kg = 75 µg
English: After reconstitution: 24 hours when stored at 25°C or in a refrigerator (2ºC - 8ºC) if kept in the original vial and protected from light.
Croatian: Nakon rekonstitucije: 24 sata pri temperaturi od 25°C ili u hladnjaku (2°C - 8°C) ako se čuva u originalnoj bočici i zaštićeno od svjetlosti.
English: Water must flow slowly onto powder.
Croatian: Vodu morate polako dodavati u prašak.
English: Carton containing 1 or 4 vials of either 125 micrograms (beige cap), 250 micrograms (red cap) or 500 micrograms of romiplostim (blue cap).
Croatian: Kutija sadrži 1 ili 4 bočice sa 125 mikrograma romiplostima (bež kapica), 250 mikrograma romiplostima (crvena kapica) ili 500 mikrograma romiplostima (plava kapica).
English: Rescue therapies allowed in the study were IVIG, platelet transfusions, anti-D immunoglobulin, and corticosteroids.
Croatian: Hitne terapije dopuštene u ovom ispitivanju bile su intravenski imunoglobulin (i.v. Ig), transfuzije trombocita, anti-D imunoglobulin te kortikosteroidi.
English: • Select your injection site.
Croatian: • Odaberite mjesto za injekciju.
English: Note: From a microbiological point of view, the product must be used immediately after reconstitution.
Croatian: Napomena: S mikrobiološkog stajališta, lijek se mora primijeniti odmah nakon rekonstitucije.
English: It is unknown whether romiplostim/metabolites are excreted in human milk.
Croatian: Nema podataka o izlučivanju romiplostima/njegovih metabolita u majčino mlijeko.
English: Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Croatian: Liječenje romiplostimom se mora prekinuti ako nakon četiri tjedna liječenja romiplostimom u maksimalnoj tjednoj dozi od 10 µg/kg broj trombocita ne naraste do razine dovoljne da bi se spriječilo klinički značajno krvarenje.
English: Photosensitivity reaction Acne
Croatian: Fotosenzitivna reakcija Akne
English: Individual patient dose (mcg) = weight (kg) x dose in mcg/kg
Croatian: Individualna doza za bolesnika (µg) = težina (kg) x doza u µg/kg
English: Nplate is a white powder for solution for injection supplied in a single-dose glass vial.
Croatian: Nplate je bijeli prašak za otopinu za injekciju dostupan u jednodoznoj staklenoj bočici.
English: Doses were adjusted to maintain (50 to 200 x 10
Croatian: Doze su bile prilagođene da održavaju broj trombocita od 50 do 200 x 109/l.
English: Pharmacokinetics of romiplostim in patients with renal and hepatic impairment has not been investigated.
Croatian: Farmakokinetika romiplostima u bolesnika s oštećenjem funkcije bubrega i jetre nije ispitivana.
English: In the Phase 3 paediatric study, the mean (SD) number of composite bleeding episodes (see section 5.1) was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm.
Croatian: U ispitivanju faze 3 u pedijatrijskih bolesnika, srednja vrijednost (SD) broja kompozitnih događaja krvarenja (vidjeti dio 5.1) bila je 1,9 (4,2) za skupinu na romiplostimu i 4,0 (6,9) za skupinu na placebu.
English: Correct
Croatian: Ispravno
English: • Do not re-use items.
Croatian: • Nemojte ponovno koristiti dijelove pribora.
English: • injection site reactions;
Croatian: • reakcije na mjestu primjene injekcije;
English: • bone marrow disorder, including increased bone marrow fibres (reticulin);
Croatian: • poremećaj koštane srži, uključujući povećanje vlakana (retikulina) u koštanoj srži;
English: The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Croatian: Ponovna pojava trombocitopenije vjerojatna je nakon prekida liječenja (vidjeti dio 4.4).
English: In adult clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
Croatian: Tijekom kliničkih ispitivanja u odraslih, liječenje romiplostimom prekinuto je u 4 od 271 bolesnika zbog odlaganja retikulina u koštanoj srži.
English: Upper abdominal pain***
Croatian: Bol u gornjem dijelu abdomena***
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: može se javiti u više od 1 na 10 osoba
English: A total of 31 subjects (47.7%) used concurrent ITP therapy during the study including 23 subjects (35.4%) who used rescue medication and 5 subjects (7.7%) who used concurrent ITP medication at baseline.
Croatian: Ukupno je 31 bolesnik (47,7%) istodobno primjenjivao terapiju za ITP tijekom ispitivanja, uključujući 23 bolesnika (35,4%) koji su primijenili hitnu terapiju i 5 bolesnika (7,7%) koji su istodobno primjenjivali lijekove za ITP na početku ispitivanja.
English: Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML (see section 4.4).
Croatian: Od primjećenih slučajeva MDS bolesti koja je napredovala u AML, bolesnici s RAEB-1 početnom klasifikacijom MDS-a imali su veću vjerojatnost progresije bolesti u AML (vidjeti dio 4.4).
English: Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration - a syringe with graduations of 0.01 mL should be used.
Croatian: Nplatea povučen iz bočice za supkutanu primjenu - mora se koristiti štrcaljka graduirana po 0,01 ml.
English: In clinical trials, romiplostim treatment was discontinued in 4 of the 271 patients because of bone marrow reticulin deposition.
Croatian: Tijekom kliničkih ispitivanja liječenje romiplostimom prekinuto je u 4 od 271 bolesnika zbog odlaganja retikulina u koštanoj srži.
English: Romiplostim has no amino acid sequence homology to endogenous TPO.
Croatian: Romiplostim nema slijed aminokiselina sličan endogenom trombopoetinu.
English: The platelet counts of ITP patients who received 6 weekly doses of 1 or 3 mcg/kg of romiplostim were within the range of 50 to 450 x 10
Croatian: Broj trombocita u bolesnika s ITP-om koji su primili 6 tjednih doza od 1 do 3 µg/kg romiplostima bio je u rasponu od 50 do 450x109/l u većine bolesnika.
English: Exfoliative rash Hair growth abnormal Prurigo
Croatian: Eksfolijativni osip Poremećen rast dlaka Prurigo
English: Reduction in permitted concurrent ITP medical therapies
Croatian: Smanjenje doze dopuštenih drugih lijekova za ITP
English: If individual patient dose is < 23 mcg
Croatian: Ako je individualna doza za bolesnika < 23 µg
English: Future dose adjustments are based on changes in platelet counts only and made in 1 mcg/kg increments (see table below).
Croatian: Sljedeće prilagodbe doze temelje se samo na promjenama broja trombocita, pa se doza povećava za po 1 µg/kg (vidjeti tablicu u nastavku).
English: In 1-month rat and monkey toxicology studies, a mild decrease in red blood cell count, haematocrit and haemoglobin was observed.
Croatian: U jednomjesečnim toksikološkim ispitivanjima na štakorima i majmunima uočeno je blago smanjenje broja crvenih krvnih stanica, te vrijednosti hematokrita i hemoglobina.
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 109/L.
Croatian: Svi klinički značajni (≥ stupanj 3) događaji krvarenja dogodili su se kad je broj trombocita bio < 30 x 109/l.
English: • tingling or numbness of the hands or feet (paraesthesia);
Croatian: • trnci ili obamrlost šaka ili stopala (parestezije);
English: Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0147).
Croatian: Liječenje romiplostimom rezultiralo je statistički značajno većom incidencijom odgovora trombocita u usporedbi s placebom (p = 0,0147).
English: In the subset of subjects with ITP > 12 months of duration, 29 subjects (46.0%) used concurrent ITP therapy during the study including 21 subjects (33.3%) who used rescue medication and 5 subjects (7.9%) who used concurrent ITP medication at baseline.
Croatian: U podskupini bolesnika s ITP-om u trajanju od > 12 mjeseci, 29 bolesnika (46,0%) je istodobno primjenjivalo terapiju za ITP tijekom ispitivanja, uključujući 21 bolesnika (33,3%) koji je primijenio hitnu terapiju i 5 bolesnika (7,9%) koji su istodobno primjenjivali lijekove za ITP na početku ispitivanja.
English: The primary endpoint was the incidence of durable response, defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10
Croatian: Primarna mjera ishoda bila je incidencija dugotrajnog odgovora, definirana kao postizanje broja trombocita ≥ 50 x 109/l kod najmanje 6 tjednih mjerenja od 18. do 25. tjedna liječenja.
English: • generally feeling unwell (malaise); chest pain; irritability; swelling of the face (face oedema); feeling hot; increased body temperature; feeling jittery;
Croatian: • opće loše osjećanje (malaksalost); bol u prsnom košu; razdražljivost; oticanje lica (facijalni edem); osjećaj vrućine; povišena tjelesna temperatura; osjećaj treme;
English: Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).
Croatian: Broj trombocita se mora pratiti tijekom smanjenja doze ili ukidanja drugih lijekova za ITP, kako bi se izbjeglo da njihov broj padne ispod preporučenog raspona (vidjeti dio 4.2).
English: *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
Croatian: *Pri izračunavanju doze romiplostima na početku liječenja uvijek se mora koristiti trenutnu tjelesnu težinu bolesnika.
English: Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271).
Croatian: Analizom svih odraslih bolesnika s ITP-om koji su dobivali romiplostim u 4 kontrolirana i 5 nekontroliranih kliničkih ispitivanja utvrđena je ukupna incidencija svih nuspojava od 91,5% (248/271) za ispitanike liječene romiplostimom.
English: Clinical trials in adult ITP patients examined antibodies to romiplostim.
Croatian: Klinička ispitivanja u odraslih bolesnika s ITP-om s ispitivanim protutijelima na romiplostim.
English: Hydrochloric acid (for pH adjustment) Polysorbate 20
Croatian: L-histidin kloridna kiselina (za podešavanje pH) polisorbat 20
English: The once weekly dose of romiplostim should be increased by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 10
Croatian: Daljnja tjedna doza romiplostima mora se povećavati za po 1 µg/kg, sve dok se kod bolesnika ne postigne broj trombocita ≥ 50 x 109/l.
English: (95% CI) (35%, 67%) (0%, 16%) (18%, 47%) (0%, 16%) (30%, 52%) (0%, 8%) p-value a Durable platelet response was defined as weekly platelet count ≥ 50 x 109/L for 6 or more times for study weeks 18-25 in the absence of rescue therapies any time during the treatment period.
Croatian: Broj (%) bolesnika s dugotrajnim odgovorom trombocita na stabilnoj dozi e (95% CI) (35%, 67%) (0%, 16%) (18%, 47%) (0%, 16%) (30%, 52%) (0%, 8%) p-vrijednost a Dugotrajan odgovor trombocita definiran je tjednim brojem trombocita ≥ 50 x 109/l mjeren 6 ili više puta od 18. do 25. tjedna ispitivanja, i to ako nije bila potrebna hitna (engl. rescue) terapija za vrijeme liječenja.
English: The mean (SD) number of composite bleeding episodes was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.5 (0, 4.5) in the placebo arm.
Croatian: Srednja vrijednost (SD) broja kompozitnih događaja krvarenja bila je 1,9 (4,2) za skupinu na romiplostimu i 4,0 (6,9) za skupinu na placebu s medijanom (Q1, Q3) broja događaja krvarenja od 0,0 (0, 2) za skupinu na romiplostimu i 0,5 (0, 4,5) u skupini na placebu.
English: Additionally, in the phase 3 pivotal studies, romiplostim did not affect the red blood cell and white blood cells lineages relative to placebo treated subjects.
Croatian: Uz to, u trećoj fazi pivotalnog kliničkog ispitivanja nije primijećena razlika u učinku romiplostima na eritrocitnu i leukocitnu lozu u odnosu na placebo.
English: The resulting concentration is 500 mcg/mL.
Croatian: Dobivena koncentracija je 500 µg/ml.
English: 75 kg patient is initiated at 1 mcg/kg of romiplostim.
Croatian: Kod bolesnika s težinom 75 kg se započinje s 1 µg/kg romiplostima.
English: Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.
Croatian: Unutar svake skupine učestalosti i klasifikacije organskih sustava prema MedDRA-i, nuspojave su navedene u padajućem nizu prema incidenciji.
English: Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Croatian: Težina* u kg x doza u µg/kg = Individualna doza za tog bolesnika u µg
English: Overall, a significant greater proportion of subjects in the romiplostim arm achieved the primary endpoint compared with subjects in the placebo arm (p = 0.0018).
Croatian: Ukupno, značajno veći udio bolesnika u skupini na romiplostimu postigao je primarnu mjeru ishoda u usporedbi s bolesnicima u skupini na placebu (p = 0,0018).
English: The resulting concentration is 125 mcg/mL.
Croatian: Dobivena koncentracija je 125 µg/ml.
English: Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođać Amgen Europe B.V.
English: The median (Q1, Q3) of most frequent dose received by subjects during the treatment period was 5.0 mcg/kg (1.0 mcg/kg, 10.0 mcg/kg).
Croatian: Medijan (Q1, Q3) najčešće primijenjene doze u bolesnika tijekom trajanja liječenja bio je 5,0 µg/kg (1,0 µg/kg, 10,0 µg/kg).
English: A total of 22 subjects (52%) had durable platelet response in the romiplostim arm compared with 2 subjects (10%) in the placebo arm: ≥ 1 to < 6 years 38% versus 25%; ≥ 6 to < 12 years 56% versus 11%; ≥ 12 to < 18 years 56% versus 0.
Croatian: Ukupno je 22 bolesnika (52%) imalo dugotrajan odgovor trombocita u skupini na romiplostimu u usporedbi s 2 bolesnika (10%) u skupini na placebu: ≥ 1 i < 6 godina 38% naspram 25%; ≥ 6 i < 12 godina 56% naspram 11%; ≥ 12 i < 18 godina 56% naspram 0%.
English: Myocardial infarction Heart rate increased
Croatian: Infarkt miokarda Ubrzana frekvencija srca
English: Of the 22 subjects, 2 subjects had pre-existing binding non-neutralising romiplostim antibodies at baseline.
Croatian: Od 22 bolesnika, 2 bolesnika imala su na početku ispitivanja prethodno postojeća ne-neutralizirajuća protutijela koja se vežu na romiplostim.
English: A total of 17 subjects (53.1%) had durable platelet response in the romiplostim arm compared with 1 subject (6.3%) in the placebo arm: ≥ 1 to < 6 years 28.6% versus 25%; ≥ 6 to < 12 years 63.6% versus 0%; ≥ 12 to < 18 years 57.1% versus 0%.
Croatian: Ukupno je 17 bolesnika (53,1%) imalo dugotrajan odgovor trombocita u skupini na romiplostimu u usporedbi s 1 bolesnikom (6,3%) u skupini na placebu: ≥ 1 i < 6 godina 28,6% naspram 25%; ≥ 6 i < 12 godina 63,6% naspram 0%; ≥ 12 i < 18 godina 57,1% naspram 0%.
English: Study S3 (131) was an open-label randomised 52 week trial in adult subjects who received romiplostim or medical standard of care (SOC) treatment.
Croatian: Studija S3 (131) bilo je otvoreno, randomizirano ispitivanje u trajanju od 52 tjedna u odraslih bolesnika koji su primali romiplostim ili standardnu medicinsku skrb.
English: Therefore if your doctor suspects that you have been given more Nplate than you should, it is recommended that you are monitored for any signs or symptoms of side effects and that you are given appropriate treatment immediately.
Croatian: Stoga, ako liječnik sumnja da Vam je dano više lijeka Nplate nego što treba, preporučuje se pomno praćenje Vašeg stanja zbog bilo kakvih znakova ili simptoma nuspojava, i kako biste odmah dobili odgovarajuće liječenje.
English: In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 10
Croatian: U tim slučajevima, ako je klinički opravdano, povišena gornja vrijednost trombocita može biti prihvatljiva ovisno o medicinskoj procjeni i to kod sniženja doze (200 x 109/l) i kod prekida liječenja (400 x 109/l).
English: Across all subjects, the median (Q1, Q3) number of months with platelet response was 30.0 months (13.0 months, 43.0 months) and the median (Q1, Q3) time on study was 35.0 months (23.0 months, 47.0 months).
Croatian: Za sve bolesnike, medijan (Q1, Q3) broja mjeseci s odgovorom trombocita bio je 30,0 mjeseci (13,0 mjeseci, 43,0 mjeseci), a medijan (Q1, Q3) vremena u ispitivanju bio je 35,0 mjeseci (23,0 mjeseci, 47,0 mjeseci).
English: • Keeping the vial on a table, and keeping the vial adapter in the plastic packaging, line up spike on the vial adapter to the centre of the stopper on the vial.
Croatian: • Držeći bočicu na stolu, dok je nastavak za bočicu u plastičnom pakiranju, postavite šiljak nastavka za bočicu iznad središta čepa na bočici.
English: All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 109/L.
Croatian: Svi događaji krvarenja ≥ stupnja 2 dogodili su se kad je broj trombocita bio < 50 x 109/l.
English: Total vial content of romiplostim
Croatian: Ukupni sadržaj romiplostima u bočici
English: Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML compared to lower risk MDS.
Croatian: Od zamijećenih slučajeva progresije MDS bolesti u AML, bolesnici s RAEB-1 početnom klasifikacijom MDS-a su imali veću vjerojatnost progresije bolesti u AML u usporedbi s MDS nižeg rizika.
English: Add this volume of preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection to the reconstituted vial
Croatian: Dodati ovaj volumen sterilne otopine natrijeva klorida za injekcije od 9 mg/ml (0,9%) bez konzervansa u rekonstituiranu bočicu
English: Oedema peripheral Influenza like illness Pain
Croatian: Periferni edem Bolest nalik influenci Bol
English: Neuropathy peripheral Transverse sinus thrombosis
Croatian: Periferna neuropatija Tromboza transverzalnog sinusa
English: In both adult placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/or azathioprine).
Croatian: U oba placebo kontrolirana, dvostruko slijepa ispitivanja bio je dopušten nastavak liječenja lijekovima za ITP koje su odrasli bolesnici prethodno primali u konstantnom rasporedu doziranja (kortikosteroidi, danazol i/ili azatioprin).