FrancophonIA/ELRC3.0 huggingface dataset:
English: e Stable dose defined as dose maintained within ± 1 mcg/kg during the last 8 weeks of treatment.
Croatian: e Stabilna doza definirana je kao doza održavana unutar ± 1 µg/kg tijekom posljednjih 8 tjedana liječenja.
English: Multiple dose romiplostim toxicology studies were conducted in rats for 4 weeks and in monkeys for up to 6 months.
Croatian: Toksikološka ispitivanja primjene višestrukih doza romiplostima na štakorima trajale su 4 tjedna, a na majmunima do 6 mjeseci.
English: • Take the Nplate self injection kit out of the refrigerator.
Croatian: • Izvadite pribor za samoubrizgavanje lijeka Nplate iz hladnjaka.
English: • Do not touch vial stopper after cleaning it.
Croatian: • Nemojte dodirivati čep bočice nakon što ga očistite.
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies.
Croatian: Sigurnost i djelotvornost romiplostima ispitivana je u dva placebom kontrolirana, dvostruko slijepa ispitivanja.
English: If you are also taking medicines which prevent blood clots (anticoagulants or antiplatelet therapy) there is a greater risk of bleeding.
Croatian: Ako uzimate i lijekove koji sprječavaju nastanak krvnih ugrušaka (antikoagulanse ili antitrombocitne lijekove), postoji veći rizik od krvarenja.
English: • protein in the urine.
Croatian: • bjelančevine u urinu.
English: • depression; abnormal dreams;
Croatian: • depresija; abnormalni snovi;
English: The mild form of these bone marrow changes is called “increased reticulin” and has been observed in Nplate clinical trials.
Croatian: Blaži oblik tih promjena koštane srži zove se povećanje retikulina i primijećen je u kliničkim ispitivanjima lijeka Nplate.
English: • As self-administration of Nplate is not allowed for paediatric patients, the HAT pack is intended for use with adult patients and not with paediatric patients.
Croatian: • Kako samoprimjena lijeka Nplate nije dopuštena za pedijatrijske bolesnike, pakiranje za obuku za primjenu lijeka kod kuće namijenjeno je za primjenu lijeka kod odraslih bolesnika, a ne pedijatrijskih bolesnika.
English: • Physicians who express an interest in initiating self-administration for specific patients are provided with a HAT pack for those patients.
Croatian: • Liječnici koji izraze interes za započinjanje samoprimjene kod određenih bolesnika dobivaju pakiranje za obuku za primjenu lijeka kod kuće za te bolesnike.
English: Nplate is not recommended for use in children aged under 1 year.
Croatian: Nplate se ne preporučuje za uporabu u djece mlađe od 1 godine.
English: • trouble sleeping (insomnia);
Croatian: • tegobe sa spavanjem (nesanica);
English: If reconstituted product is not used immediately, the syringe should not be removed from the vial adapter to maintain microbiological integrity.
Croatian: Ako se rekonstituiran lijek ne primijeni odmah, štrcaljka se ne smije odvojiti od nastavka za bočicu, kako bi se očuvao mikrobiološki integritet.
English: In these studies, myelofibrosis was not observed in animals after a 4-week post-treatment recovery period, indicating reversibility.
Croatian: U tim ispitivanjima mijelofibroza nije uočena u životinja 4 tjedna nakon završetka liječenja, što upućuje na to da je ta pojava reverzibilna.
English: • Do a final check to ensure the correct amount of liquid for your dose is in the syringe and all air bubbles have been removed.
Croatian: • Napravite konačnu provjeru kako biste osigurali da u štrcaljki bude ispravna količina otopine za Vašu dozu i da svi mjehurići zraka budu uklonjeni.
English: If you have any questions about storage, contact your healthcare professional for further instructions.
Croatian: Ako imate dodatnih pitanja o čuvanju lijeka, obratite se svom zdravstvenom radniku za dodatne upute.
English: Your doctor may decide to take a bone marrow biopsy if they decide it is necessary to ensure that you have ITP, and not another condition such as Myelodysplastic Syndrome (MDS).
Croatian: Vaš liječnik može odlučiti da je potrebno učiniti biopsiju koštane srži u slučaju da smatra da je potrebno dokazati da imate ITP, a ne neko od drugih stanja kao što je mijelodisplastični sindrom (MDS).
English: The safety and efficacy of romiplostim 250/500 mcg powder and solvent for solution for injection, also used for self-administration in eligible adult patients, have not been established in patients aged under 18 years.
Croatian: Sigurnost i djelotvornost romiplostima 250/500 µg praška i otapala za otopinu za injekciju, također korištene za samoprimjenu kod odraslih bolesnika koji ispunjavaju uvjete, u bolesnika mlađih od 18 godina nisu još ustanovljene.
English: Possible side effects in children with ITP
Croatian: Moguće nuspojave kod djece s ITP-om
English: If someone else is giving you the injection, they can also use the outer area of the upper arms
Croatian: Ako Vam netko drugi daje injekciju, mogu je dati i u vanjsku stranu nadlaktice.
English: In paediatric studies, the incidence of binding antibodies to romiplostim at any time was 7.8% (22/282).
Croatian: U ispitivanjima u pedijatrijskih bolesnika, incidencija protutijela koja se vežu na romiplostim u bilo kojem trenutku bila je 7,8% (22/282).
English: As a result for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa.
Croatian: Kao rezultat primijenjenih doza, bolesnici s velikim brojem trombocita imat će nižu serumsku koncentraciju i vice versa.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKOM OKU PC
English: Alterations in red (decrease) and white (increase) blood cell parameters have been observed in non-clinical toxicology studies (rat and monkey) as well as in ITP patients.
Croatian: Promjene u vrijednostima crvenih (smanjenje) i bijelih (povećanje) krvnih stanica uočeni su u nekliničkim toksikološkim ispitivanjima na životinjama (štakor i majmun), kao i u bolesnika s ITP-om.
English: • In paediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight.
Croatian: • U pedijatrijskih bolesnika, sljedeće prilagodbe doze temelje se na promjenama broja trombocita i promjenama tjelesne težine.
English: Of the 157 subjects randomised to the romiplostim group, three subjects did not receive romiplostim.
Croatian: Od 157 ispitanika koji su randomizirani u skupinu na romiplostimu, tri ispitanika nisu primila romiplostim.
English: Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Croatian: Romiplostim je proizveden tehnologijom rekombinantne DNA u bakteriji Escherichia coli (E. coli).
English: Study S1 (212) evaluated patients who were non-splenectomised and had an inadequate response or were intolerant to prior therapies.
Croatian: Ispitivanje S1 (212) pratilo je nesplenektomirane bolesnike, koji su imali neodgovarajući terapijski odgovor ili nisu dobro podnosili prethodne terapije.
English: Contents of the pack and other information Instructions for preparing and giving an injection of Nplate
Croatian: Sadržaj pakiranja i druge informacije Upute za pripremu i davanje injekcije lijeka Nplate
English: • Step 3b: Holding the syringe with one hand, bend the tip of the white plastic cover downward with your other hand.
Croatian: • Korak 3b: Držeći štrcaljku jednom rukom, drugom rukom savijte bijeli plastični poklopac prema dolje.
English: • weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
Croatian: • mršavljenje; debljanje; nepodnošenje alkohola; gubitak apetita (anoreksija ili smanjen apetit); dehidracija;
English: Volume of sterile water for injection
Croatian: Volumen sterilne vode za injekciju
English: Similar to adults with ITP, romiplostim pharmacokinetics are highly variable in paediatric subjects with ITP and are not reliable and predictive.
Croatian: Slično odraslim bolesnicima s ITP-om, farmakokinetička svojstva romiplostima su visokovarijabilna u pedijatrijskih bolesnika s ITP-om te nisu pouzdana ni predvidljiva.
English: Bleeding events
Croatian: Događaji krvarenja
English: Water should flow slowly onto powder.
Croatian: Voda treba polako teći na prašak.
English: Both subjects tested negative for neutralising antibodies to romiplostim at 4 months after the end of dosing.
Croatian: Oba ispitanika su bila negativna za neutralizirajuća protutijela na romiplostim 4 mjeseca nakon prekida terapije.
English: Keep the Nplate self injection kit refrigerated at 2ºC to 8ºC.
Croatian: Čuvajte pribor za samoubrizgavanje lijeka Nplate u hladnjaku na temperaturi od 2ºC do 8ºC.
English: • With one hand, gently pinch the cleaned area of skin and hold it firmly.
Croatian: • Jednom rukom nježno uhvatite nabor očišćene kože i čvrsto ga držite.
English: Hypoaesthesia Hypogeusia
Croatian: Hipoestezija Hipogeuzija
English: The incidence of pre-existing antibodies to romiplostim and TPO was 8.0% and 5.4%, respectively.
Croatian: Incidencija od prije postojećih protutijela na romiplostim i TPO je bila 8,0%, odnosno 5,4%.
English: Of the 271 patients who received romiplostim in ITP clinical trials, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over.
Croatian: Od 271 bolesnika koji su primili romiplostim u kliničkim ispitivanjima ITP-a, njih 55 (20%) je imalo 65 godina ili više, a među njima je bilo 27 (10%) u dobi od 75 godina ili starijih.
English: The mean duration of exposure to romiplostim in this study population was 50 weeks.
Croatian: Prosječno trajanje izloženosti romiplostimu u ispitivanoj populaciji bolesnika bilo je 50 tjedana.
English: B. Maintain pressure on plunger.
Croatian: Zadržite pritisak na klip.
English: Patients received single subcutaneous weekly injections for 24 weeks.
Croatian: Bolesnici su dobivali jednu injekciju tjedno supkutano tijekom 24 tjedna.
English: The injection device and Nplate vial must NEVER be reused.
Croatian: Pribor za davanje injekcije i bočica lijeka Nplate NIKAD se ne smiju ponovno uporabiti.
English: • Inject the prescribed dose subcutaneously as directed by your doctor, nurse or pharmacist.
Croatian: • Ubrizgajte propisanu dozu potkožno, kako su Vas uputili liječnik, medicinska sestra ili ljekarnik.
English: The volume of distribution of romiplostim following intravenous administration of romiplostim decreased nonlinearly from 122, 78.8, to 48.2 mL/kg for intravenous doses of 0.3, 1.0 and 10 mcg/kg, respectively in healthy subjects.
Croatian: Volumen distribucije romiplostima nakon intravenske primjene smanjuje se nelinearno sa 122, 78,8 na 48,2 ml/kg za intravenske doze od 0,3, 1,0 i 10 µg/kg u zdravih ljudi.
English: Dilution Guidelines:
Croatian: Smjernice o razrjeđivanju:
English: Common: may affect up to 1 in 10 people (may show up in blood or urine tests)
Croatian: Često: može se javiti u do 1 na 10 osoba (mogu se pojaviti kod pretraga krvi ili mokraće)
English: In embryo-foetal development studies in mice and rats, reductions in maternal body weight were found only in mice.
Croatian: U embrio-fetalnim razvojnim ispitivanjima kod miševa i štakora, samo u skotnih mišica došlo je do smanjenja tjelesne težine.
English: A total of 2.2% (4/184) adult patients developed binding, non-neutralising antibody against TPO.
Croatian: Ukupno je 2,2% (4/184) odraslih bolesnika razvilo ne-neutralizirajuća protutijela koja se vežu na TPO.
English: • Do not delay injecting Nplate.
Croatian: • Nemojte odgađati ubrizgavanje lijeka Nplate.
English: Note: To prevent contamination of the product, do not touch the vial adapter spike or Luer lock.
Croatian: Napomena: Da bi se spriječila kontaminacija lijeka, nemojte dodirivati vršak nastavka za bočicu i priključak tipa Luer lock.
English: • Make sure the top of the plunger head lines up with the syringe marking that matches your prescribed dose.
Croatian: • Pazite da vrh klipa bude poravnat s oznakom na štrcaljki tako da odgovara dozi koja Vam je propisana.
English: • a rare disorder characterised by periods of burning pain, redness and warmth in the feet and hands (erythromelalgia).
Croatian: • rijetki poremećaj karakteriziran razdobljima goruće boli, crvenila i vrućine u stopalima i šakama (eritromelalgija).
English: Twenty-one non-splenectomised and 18 splenectomised patients received on-study ITP medical treatments (primarily corticosteroids) at the start of study.
Croatian: Dvadeset jedan nesplenektomiran i 18 splenektomiranih bolesnika nastavilo je uzimati prethodne lijekove za ITP (uglavnom kortikosteroide) od početka ispitivanja.
English: Of the 66 subjects enrolled in the study, 63 subjects had ITP > 12 months of duration.
Croatian: Od 66 bolesnika uključenih u ispitivanje, 63 bolesnika je imalo ITP u trajanju od > 12 mjeseci.
English: It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
Croatian: Preporučuje se, ako je prekinuta terapija romiplostimom, da se liječenje ITP-a nastavi prema trenutačnim terapijskim smjernicama.
English: Romiplostim had no observed effect on the fertility of rats.
Croatian: Nije uočen učinak romiplostima na plodnost štakora.
English: It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju osim ako Vam liječnik, medicinska sestra ili ljekarnik nisu pokazali kako to učiniti.
English: The Nplate self injection kit must be kept in the original package until use in order to protect the Nplate vial from light.
Croatian: Pribor za samoubrizgavanje lijeka Nplate mora se čuvati do uporabe u originalnom pakiranju radi zaštite bočice lijeka Nplate od svjetlosti.
English: Romiplostim should be used with caution in these populations.
Croatian: Romiplostim se mora primjenjivati s oprezom u tim populacijama bolesnika.
English: The diagnosis of ITP in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Croatian: Dijagnoza ITP-a se mora potvrditi u odrasloj i starijoj životnoj dobi isključujući ostale kliničke entitete koji se prezentiraju s trombocitopenijom, posebno se mora isključiti dijagnoza MDS-a.
English: Romiplostim is known to cross the placental barrier in rats and may be transmitted from the mother to the developing foetus and stimulate foetal platelet production.
Croatian: Za romiplostim se zna da prolazi kroz placentnu barijeru u štakora te se može prenijeti s majke na fetus u razvoju i stimulirati stvaranje trombocita u fetusa.
English: This study evaluated non-splenectomised patients with ITP and platelet counts < 50 x 10
Croatian: Ova je studija ocjenjivala nesplenektomirane bolesnike s ITP-om i brojem trombocita < 50 x 109/l.
English: Results from pivotal placebo-controlled studies
Croatian: Rezultati pivotalnih placebo kontroliranih ispitivanja
English: Elimination half-life of romiplostim in ITP patients ranged from 1 to 34 days (median, 3.5 days).
Croatian: Poluvrijeme eliminacije romiplostima u ITP bolesnika je između jednog i 34 dana (medijan 3,5 dana).
English: • or cancer of white blood cells (multiple myeloma);
Croatian: • ili rak bijelih krvnih stanica (multipli mijelom);
English: Localised infection Nasopharyngitis
Croatian: Lokalizirana infekcija Nazofaringitis
English: A total of 3.2% (9/282) subjects had binding antibodies to TPO at any time during romiplostim treatment.
Croatian: Ukupno je 3,2% (9/282) bolesnika imalo protutijela koja se vežu na TPO u bilo kojem trenutku tijekom liječenja romiplostimom.
English: Results of studies compared to standard of care (SOC) in non-splenectomised patients
Croatian: Rezultati studija u usporedbi sa standardnom skrbi u nesplenektomiranih bolesnika
English: • Do not inject into areas with scars or stretch marks.
Croatian: • Nemojte ubrizgavati u područje s ožiljcima ili strijama.
English: No other diluents have been tested.
Croatian: Nisu ispitane druge otopine za razrjeđivanje.
English: Patients eligible for self-administration of Nplate should be trained in these procedures.
Croatian: Bolesnici koji ispunjavaju uvjete za samoprimjenu lijeka Nplate trebaju biti educirani u tim postupcima.
English: Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Croatian: Lijekovi koji su korišteni u liječenju ITP-a u kombinaciji s romiplostimom u kliničkim ispitivanjima uključuju kortikosteroide, danazol, i/ili azatioprin, intravenski imunoglobulin (i.v. Ig) i anti-D imunoglobulin.
English: All subjects were negative for neutralising activity to TPO.
Croatian: Svi bolesnici bili su negativni na neutralizirajuće djelovanje na TPO.
English: How to use Nplate
Croatian: Kako čuvati Nplate
English: • painful swollen joints caused by uric acid (food breakdown product) (gout);
Croatian: • bolni oteknuti zglobovi uzrokovani nakupljanjem mokraćne kiseline (nastaje razgradnjom hrane) (giht);
English: In an ongoing paediatric clinical trial, of the subjects with an evaluable on-study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin in cohort 1 and 2 out of 4 subjects (50.0%) developed increased reticulin in cohort 2.
Croatian: U kliničkom ispitivanju u pedijatrijskih bolesnika koje je u tijeku, od bolesnika sa procjenjivom biopsijom koštane srži tijekom ispitivanja, u 5 od 27 bolesnika (18,5%) razvio se povećan retikulin u kohorti 1, a u 2 od 4 bolesnika (50,0%) razvio se povećan retikulin u kohorti 2.
English: The composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period.
Croatian: Kompozitni događaj krvarenja definiran je kao klinički značajan događaj krvarenja ili uporaba hitne (engl. rescue) terapije za sprečavanje klinički značajnog događaja krvarenja od 2. do 25. tjedna liječenja.
English: In mice there was evidence of increased post-implantation loss.
Croatian: U miševa postoji dokaz o povećanom gubitku fetusa.
English: Pharmacotherapeutic group: Antihaemorrhagics, other systemic haemostatics, ATC code: B02BX04
Croatian: Farmakoterapijska skupina: antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX04
English: Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy.
Croatian: Sumnja na povećanje retikulina može se postaviti na osnovi morfoloških promjena perifernih krvnih stanica, a može se potvrditi biopsijom koštane srži.
English: Nplate is a sterile but unpreserved medicinal product and is intended for single use only.
Croatian: Nplate je sterilan, ali nekonzerviran lijek namijenjen za jednokratnu uporabu.
English: Nplate works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets.
Croatian: Nplate potiče koštanu srž (dio kosti koji stvara krvne stanice) na stvaranje više trombocita.
English: While 5.8% and 3.9% of the subjects were positive for developing binding antibodies to romiplostim and TPO respectively, only 2 subjects (0.4%) were positive for neutralising antibodies to romiplostim but these antibodies did not cross react with endogenous TPO.
Croatian: Dok je 5,8% ispitanika bilo pozitivno na razvijanje protutijela koja se vežu na romiplostim i 3,9% na TPO, samo su 2 ispitanika (0,4%) bila pozitivna na neutralizirajuća protutijela na romiplostim, ali ta protutijela nisu pokazivala križnu reakciju s endogenim TPO.
English: Romiplostim must not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Croatian: Romiplostim se ne smije koristiti za liječenje trombocitopenije zbog MDS-a ili bilo kojeg uzroka trombocitopenije osim ITP-a izvan kliničkih ispitivanja.
English: Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package.
Croatian: Potrebna su: 2 pakiranja vatica natopljenih alkoholom, 1 bočica i 1 pakiranje s nastavkom za bočicu.
English: In the paediatric studies, 282 paediatric ITP subjects were treated with romiplostim in 2 controlled and 3 uncontrolled clinical trials.
Croatian: U ispitivanjima u pedijatrijskih bolesnika, 282 pedijatrijska bolesnika s ITP-om liječena su romiplostimom u 2 kontrolirana i 3 nekontrolirana klinička ispitivanja.
English: Among the 154 subjects who received romiplostim, the total median exposure to romiplostim was 52.0 weeks and ranged from 2 to 53 weeks.
Croatian: Od 154 ispitanika koji su primili romiplostim, ukupni medijan izloženosti romiplostimu bio je 52,0 tjedana, u rasponu od 2 do 53 tjedna.
English: Always cover the needle with the pink safety cover before disposal.
Croatian: Uvijek prekrijte iglu ružičastim zaštitnim mehanizmom prije nego što je bacite.
English: The vial contents may be swirled gently and inverted during dissolution.
Croatian: Sadržaj bočice može se lagano vrtjeti i preokretati tijekom otapanja.
English: Hypersensitivity** Angioedema
Croatian: Preosjetljivost** Angioedem
English: There are no or limited amount of data from the use of romiplostim in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni romiplostima u trudnica ograničeni.
English: Romiplostim pharmacokinetics appear not affected by age, weight and gender to a clinically significant extent.
Croatian: Na farmakokinetiku romiplostima, čini se, ne utječu klinički značajno dob, tjelesna težina i spol.
English: Possible side effects in adults with ITP
Croatian: Moguće nuspojave kod odraslih s ITP-om
English: Slowly push the plunger up to force the air bubbles out of the syringe.
Croatian: Polako potiskujte klip prema gore kako biste istisnuli mjehuriće zraka iz štrcaljke.
English: Your doctor will take regular blood samples to measure how your platelets are responding and may adjust your dose as necessary.
Croatian: Liječnik će redovito uzimati uzorke krvi kako bi odredio broj trombocita te može prilagoditi Vašu dozu ako je potrebno.
English: • Withdraw the full amount of liquid into the syringe.
Croatian: • Uvucite cijelu količinu tekućine u štrcaljku.
English: • Do not inject into areas where the skin is tender, bruised and hard.
Croatian: • Nemojte davati injekciju u područjima gdje je koža nježna, otvdnula ili su prisutne modrice.
English: Platelet counts should be monitored in patients receiving Nplate (see sections 4.2, 4.4 and 4.9).
Croatian: Treba pratiti broj trombocita u bolesnika koji primaju Nplate (vidi dio 4.2, 4.4 i 4.9).
English: You can press a cotton ball or gauze over the injection site for 10 seconds.
Croatian: Možete ga pritisnuti komadićem vate ili gaze na 10 sekundi.
English: Paediatric subjects who had completed a prior romiplostim study (including study S4) were allowed to enroll in study S6 (340), an open-label extension study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic paediatric subjects with ITP.
Croatian: Pedijatrijskim bolesnicima koji su završili prethodno ispitivanje romiplostima (uključujući ispitivanje S4) dozvoljeno je uključivanje u ispitivanje S6 (340), otvoreni nastavak ispitivanja sigurnosti i djelotvornosti dugotrajne primjene romiplostima u trombocitopeničnih pedijatrijskih bolesnika s ITPom.
English: Nplate has moderate influence on the ability to drive and use machines.
Croatian: Nplate može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Study S4 (279) was a phase 3 study with 24 weeks of romiplostim treatment and study S5 (195) was a phase 1/2 study with 12 weeks of romiplostim treatment (up to 16 weeks for eligible responders who enter a 4-week pharmacokinetic assessment period).
Croatian: Ispitivanje S4 (279) bilo je ispitivanje faze 3 u trajanju od 24 tjedna liječenja romiplostimom, a ispitivanje S5 (195) bilo je ispitivanje faze 1/2 u trajanju od 12 tjedana liječenja romiplostimom (do 16 tjedana za bolesnike koji ispunjavaju uvjete s odgovorom na terapiju uključene u farmakokinetičku procjenu u trajanju od 4 tjedna).