FrancophonIA/ELRC3.0 huggingface dataset:
English: A vial of powder, either 250 micrograms OR 500 micrograms x1
Slovenian: 1 x vialo praška, 250 mikrogramsko ALI 500 mikrogramsko
English: Mean no. weeks with platelet response c
Slovenian: Povprečno št. tednov z odzivom trombocitov c
English: • muscle tightness; muscular weakness; shoulder pain; muscle twitching;
Slovenian: • napetost mišic, šibkost mišic, bolečine v rami, trzanje mišic,
English: In the longer duration chronic monkey study, there was no effect on the erythroid and leukocytic lineages when romiplostim was administered for 6 months where the administration of romiplostim was decreased from thrice weekly to once weekly.
Slovenian: V dolgotrajnejši kronični študiji pri opicah so romiplostim uporabljali 6 mesecev, pri čemer so dajanje zmanjšali iz trikrat na teden na enkrat na teden; med to 6-mesečno študijo niso ugotovili vpliva na eritroidno in levkocitno vrsto.
English: Nplate is a white powder for solution for injection supplied in a 5 mL single-dose glass vial.
Slovenian: Zdravilo Nplate je bel prašek za raztopino za injiciranje v 5 ml enoodmerni stekleni viali.
English: Powder and solvent for solution for injection (powder for injection).
Slovenian: prašek in vehikel za raztopino za injiciranje (prašek za injekcijo) Prašek je bel.
English: • higher than normal platelet counts (thrombocytosis);
Slovenian: • število trombocitov, večje od normalnega (trombocitoza),
English: Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Slovenian: Romiplostim je treba previdno uporabljati pri bolnikih z znanimi dejavniki tveganja za tromboembolije, vključno (vendar ne samo) s podedovanimi (npr. faktorjem V Leiden) ali pridobljenimi dejavniki tveganja (npr. pomanjkanjem ATIII, antifosfolipidnim sindromom), višjo starostjo, dolgotrajno imobilizacijo, malignomi, uporabo kontraceptivov in hormonskega nadomestnega zdravljenja, operacijo/poškodbo, debelostjo in kajenjem.
English: Bleeding events that were grade 2 or higher were reported by 15% of patients treated with romiplostim and 34% of patients treated with placebo (Odds Ratio; [romiplostim/placebo] = 0.35; 95% CI = (0.14, 0.85)).
Slovenian: O krvavitvah stopnje 2 ali več so poročali pri 15 % bolnikov, zdravljenih z romiplostimom, in 34 % bolnikov, zdravljenih s placebom (razmerje obetov [romiplostim/placebo] = 0,35; 95 % IZ = (0,14, 0,85)).
English: WATER FOR INJECTIONS LABEL
Slovenian: NALEPKA ZA VODO ZA INJEKCIJE
English: Across the study, the overall subject incidence of platelet response (1 or more platelet count ≥ 50 x 10
Slovenian: V preskušanju je celokupna incidenca odgovora trombocitov (število trombocitov ≥ 50 x 10
English: Individual patient dose (mcg) = 10 kg x 1 mcg/kg = 10 mcg
Slovenian: Odmerek za posameznega bolnika (µg) = 10 kg x 1 µg/kg = 10 µg
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 109/L.
Slovenian: Vse klinično pomembne (≥ 3. stopnje) krvavitve so se pojavile pri številu trombocitov < 30 x 109/l.
English: For instructions on reconstitution and administration of the medicinal product, see section 6.6.
Slovenian: Za navodila o pripravi in uporabi zdravila glejte poglavje 6.6.
English: Dissolving Nplate by injecting water into vial
Slovenian: 4. korak: Raztapljanje zdravila Nplate z injiciranjem vode v vialo
English: Remove the empty pre-filled syringe from the vial adapter.
Slovenian: Odstranite prazno napolnjeno injekcijsko brizgo z nastavka za vialo.
English: The resulting concentration is 500 mcg/mL.
Slovenian: Koncentracija je tako 500 µg/ml.
English: • problems with your nervous system including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); decrease in sense of taste (hypogeusia); decreased feeling of sensitivity, especially in the skin (hypoaesthesia); alteration in the nerve functions in the arms and legs (neuropathy peripheral); blood clot in the transverse sinus (transverse sinus thrombosis);
Slovenian: • težave z živčevjem, vključno z nehotenim krčenjem mišic (klonus), moteno okušanje (dizgevzija), zmanjšano okušanje (hipogevzija), zmanjšana občutljivost, zlasti na koži (hipoestezija), spremenjeno delovanje živcev v rokah in nogah (periferna nevropatija), krvni strdek v transverzalnem sinusu (tromboza tranzverzalnega sinusa),
English: * see section 4.4 ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema
Slovenian: ** Preobčutljivostne reakcije vključno s primeri izpuščaja, urtikarije in angioedema.
English: 1 pre-filled syringe containing 0.72 mL of water for injections for reconstitution.
Slovenian: 1 napolnjeno injekcijsko brizgo, ki vsebuje 0,72 ml vode za injekcije za pripravo.
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 10
Slovenian: Vse klinično pomembne krvavitve (stopnja 3 ali več) so se zgodile pri številu trombocitov < 30 x 10
English: All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 10
Slovenian: Vse krvavitve stopnje 2 ali več so se zgodile pri številu trombocitov < 50 x 10
English: If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Slovenian: Če imate vprašanja o injiciranju zdravila, se za pomoč obrnite na vašega zdravnika, medicinsko sestro ali farmacevta.
English: • Do not delay injecting Nplate.
Slovenian: • Zdravilo Nplate injicirajte brez odlašanja.
English: The primary endpoint was the incidence of durable response, defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10
Slovenian: Trajen odziv na zdravljenje je bil definiran kot vsaj 6 doseženih vrednosti števila trombocitov ≥ 50 x 10
English: Across the entire adult ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed.
Slovenian: V celotnem kliničnem programu ITP odraslih je bilo opaziti obratno sorazmerno povezavo med krvavitvami in številom trombocitov.
English: The 125 mcg vial cap is beige, the 250 mcg vial cap is red and the 500 mcg vial cap is blue.
Slovenian: Zaporka viale s 125 µg je bež barve, zaporka viale z 250 µg je rdeče barve in zaporka viale s 500 µg je modre barve.
English: • problems with the circulation including blood clot in the vein in the liver (portal vein thrombosis); deep vein thrombosis; low blood pressure (hypotension); increased blood pressure; blocking of a blood vessel or (peripheral embolism); reduced blood flow in the hands, ankles or feet (peripheral ischaemia); swelling and clotting in a vein, which may be extremely tender when touched (phlebitis or thrombophlebitis superficial); blood clot (thrombosis);
Slovenian: • težave s krvnim obtokom, vključno s krvnim strdkom v jetrni veni (tromboza portalne vene), globoka venska tromboza, nizek krvni tlak (hipotenzija), zvišan krvni tlak, zamašitev krvne žile (periferna embolija), zmanjšan pretok krvi v dlaneh, gležnjih ali stopalih (periferna ishemija), oteklost in strjevanje v veni, lahko z izredno občutljivostjo na dotik (flebitis ali povrhnji tromboflebitis), krvni strdek (tromboza),
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.
Slovenian: V nekliničnih toksikoloških študijah (na podganah in opicah) so opažali spremembe vrednosti rdečih (znižanje) in belih (zvišanje) krvnih celic.
English: Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Slovenian: Telesna masa* v kg x odmerek v µg/kg = odmerek v µg za posameznega bolnika
English: • Immediately discard syringe with covered needle into a sharps container.
Slovenian: • Brizgo s pokrito iglo takoj zavrzite v vsebnik za ostre odpadke.
English: If the calculated individual patient dose is less than 23 mcg, dilution with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate dosing (see section 6.6).
Slovenian: Če je izračunan odmerek za posameznega bolnika manjši od 23 µg, je potrebno zdravilo razredčiti s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez konzervansov, zato da se zagotovi natančno odmerjanje (glejte poglavje 6.6).
English: All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 109/L.
Slovenian: Vse krvavitve ≥ 2. stopnje so se pojavile pri številu trombocitov < 50 x 109/l.
English: 1 pre-filled syringe containing 1.2 mL of water for injections for reconstitution.
Slovenian: 1 napolnjeno injekcijsko brizgo, ki vsebuje1,2 ml vode za injekcije za pripravo.
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.
Slovenian: Če je zdravilo shranjeno v originalni ovojnini, ga lahko vzamete iz hladilnika za obdobje 30 dni pri sobni temperaturi (do 25 °C).
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.
Slovenian: V skupini, ki je prejemala romiplostim, je skupno 22 bolnikov (52 %) doseglo trajen odziv trombocitov v primerjavi z 2 bolnikoma (10 %) v skupini, ki je prejemala placebo: ≥ 1 leto do < 6 let: 38 % bolnikov, ki so prejemali romiplostim, in 25 % bolnikov, ki so prejemali placebo; ≥ 6 let do < 12 let: 56 % bolnikov, ki so prejemali romiplostim, in 11 % bolnikov, ki so prejemali placebo; ≥ 12 let do < 18 let: 56 % bolnikov, ki so prejemali romiplostim, in 0 bolnikov, ki so prejemali placebo.
English: Nplate 500 micrograms powder and solvent for solution for injection: Pre-filled syringe (type 1 clear glass with bromobutyl rubber plunger) containing 1.2 mL of water for injections for reconstitution.
Slovenian: Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje: Napolnjena injekcijska brizga (prozorno steklo tipa 1 z batom iz bromobutilne gume) vsebuje 1,2 ml vode za injekcije za pripravo.
English: In clinical trials, treatment with romiplostim resulted in dose-dependent increases in platelet count.
Slovenian: V kliničnih preskušanjih je zdravljenje z romiplostimom povzročilo od odmerka odvisno povečanje števila trombocitov.
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 34.0 months
Slovenian: V skupini vseh bolnikov je znašala mediana (Q1, Q3) števila mesecev z odgovorom trombocitov 30,0 mesecev (13,0 mesecev, 43,0 mesecev) in mediana (Q1, Q3) časa vključenosti v preskušanje je znašala 34,0 mesecev (24,0 mesecev, 46,0 mesecev).
English: Deliverable product and volume
Slovenian: Uporabno zdravilo in količina
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%.
Slovenian: V skupini, ki je prejemala romiplostim, je skupno 17 bolnikov (53,1 %) je doseglo trajen odziv trombocitov v primerjavi z 1 bolnikom (6,3 %) v skupini, ki je prejemala placebo: ≥ 1 leto do < 6 let: 28,6 % bolnikov, ki so prejemali romiplostim, in 25 % bolnikov, ki so prejemali placebo; ≥ 6 let do < 12 let: 63,6 % bolnikov, ki so prejemali romiplostim in 0 % bolnikov, ki so prejemali placebo; ≥ 12 let do < 18 let: 57,1 % bolnikov, ki so prejemali romiplostim, in 0 % bolnikov, ki so prejemali placebo.
English: Transient platelet response was defined as weekly platelet count ≥ 50 x 10
Slovenian: Trajni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 10
English: You may have excess Nplate left over after administering your prescribed dose.
Slovenian: Morda vam bo po injiciranju predpisanega odmerka ostalo še nekaj zdravila Nplate.
English: Keep the dissolved Nplate Vial.
Slovenian: Obdržite vialo z raztopljenim zdravilom Nplate.
English: • cough;
Slovenian: • kašelj,
English: • sore throat and discomfort when swallowing (pharyngitis);
Slovenian: • boleče grlo in nelagodje ob požiranju (faringitis),
English: If the calculated individual patient dose is less than 23 mcg (see section 4.2), an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below).
Slovenian: Če je izračunan odmerek za posameznega bolnika nižji od 23 µg (glejte poglavje 4.2), je potreben dodaten korak redčenja do 125 µg/ml s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov za zagotovitev natančne količine (glejte tabelo spodaj).
English: Individual patient dose (mcg) = weight (kg) x dose in mcg/kg
Slovenian: Odmerek za posameznega bolnika (µg) = telesna masa (kg) x odmerek v µg/kg
English: Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended.
Slovenian: Zato je pred zdravljenjem z romiplostimom in med njim priporočljivo opraviti pregled razmaza periferne krvi na morfološke nepravilnosti celic in določitev celotne krvne slike.
English: If you stop using Nplate, your low blood platelet count (thrombocytopenia) is likely to reoccur.
Slovenian: Če nehate uporabljati zdravilo Nplate, se bo verjetno znova pojavilo premajhno število trombocitov (trombocitopenija).
English: If you have not been trained, please contact your healthcare professional.
Slovenian: Če vas tega še niso naučili, se posvetujte s svojim zdravnikom.
English: Water for injections should be injected into the vial.
Slovenian: V vialo morate injicirati vodo za injekcije.
English: It may harm them,
Slovenian: • vnetje očesa (konjuktivitis),
English: Each vial of Nplate 250 micrograms powder for solution for injection contains a total of 375 micrograms of romiplostim.
Slovenian: Ena viala zdravila Nplate 250 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 375 mikrogramov romiplostima.
English: 1 sterile vial adapter.
Slovenian: 1 sterilen nastavek za vialo.
English: 230 mcg
Slovenian: 230 µg
English: Ensure the correct amount of solution for the patient dose is in the administration syringe by injecting any excess solution back into the vial.
Slovenian: Poskrbite, da je v brizgi za injiciranje prava količina raztopine za bolnikov odmerek: to naredite tako, da injicirate odvečno raztopino nazaj v vialo.
English: • diarrhoea;
Slovenian: • migrena,
English: Nplate is used to treat patients aged 1 year and over who may or may not have had their spleen removed for chronic ITP and who have been previously treated with corticosteroids or immunoglobulins, where these treatments don't work.
Slovenian: Zdravilo Nplate uporabljamo za zdravljenje bolnikov (starih 1 leto in več), ki so jim ali pa jim niso zaradi kronične ITP odstranili vranico in so pred tem dobivali kortikosteroide ali imunoglobuline, ki pri njih niso učinkoviti.
English: • Do ensure that all water is injected from the syringe into the vial before dissolving.
Slovenian: • Pred raztapljanjem se prepričajte, da ste iz brizge v vialo injicirali vso vodo.
English: Keeping the vial on the bench, attach the pre-filled syringe of water for injections to vial adapter: hold the outer edge of the vial adapter with one hand and twist the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance.
Slovenian: Viala naj stoji na podlagi; v tem položaju namestite napolnjeno injekcijsko brizgo z vodo za injekcije na nastavek za vialo: z eno roko držite zunanji rob nastavka za vialo in z drugo roko zasučite konico brizge v smeri urnega kazalca v nastavek, dokler ne začutite rahlega upora.
English: Immediately discard syringe and needle into an approved Sharps Container.
Slovenian: Brizgo in iglo takoj zavrzite v ustrezen vsebnik za ostre odpadke.
English: Protein urine present
Slovenian: Bolezni sečil beljakovine v urinu
English: • Do dispose of the used needle and syringe in a puncture-resistant container.
Slovenian: • Zavrzite uporabljeno iglo in brizgo v vsebnik, odporen proti prebadanju.
English: = 250 mcg in 0.50 mL
Slovenian: = 250 µg v 0,50 ml
English: RECONSTITUTION PACK OUTER CARTON WITH BLUE BOX
Slovenian: ZUNANJA OVOJNINA KOMPLETA ZA PRIPRAVO Z MODRIM OKENCEM
English: 1 sterile 1 mL Luer lock syringe.
Slovenian: 1 sterilno 1 ml brizgo z nastavkom Luer.
English: Apply strong force while twisting to attach the safety needle onto syringe.
Slovenian: Med sukanjem močno pritisnite, da boste varnostno iglo namestili na brizgo.
English: No. (%) patients with durable platelet response a
Slovenian: Št. (%) bolnikov s trajnim odzivom trombocitov a
English: Each vial of Nplate 500 micrograms powder for solution for injection contains a total of 625 micrograms of romiplostim.
Slovenian: Ena viala zdravila Nplate 500 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 625 mikrogramov romiplostima.
English: Powder for solution for injection (powder for injection).
Slovenian: prašek za raztopino za injiciranje (prašek za injekcijo) Prašek je bel.
English: Treatment with romiplostim resulted in statistically significantly greater incidence of platelet response compared with placebo (p = 0.0008).
Slovenian: V skupini, ki je prejemala zdravljenje z romiplostimom, je bilo statistično značilno višja incidenca odziva trombocitov v primerjavi s skupino, ki je prejemala placebo (p = 0,0008).
English: It is not known if this may progress to a more severe form called “fibrosis.” Signs of bone marrow changes may show up as abnormalities in your blood tests.
Slovenian: Ni znano, ali lahko napreduje v hujšo obliko, ki jo imenujemo "fibroza".
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.
Slovenian: V preskušanju faze 3 pediatričnih bolnikov je bilo povprečje števila sestavljenih krvavitev (glejte poglavje 5.1) v skupini, ki je prejemala romiplostim, 1,9 (4,2) in v skupini, ki je prejemala placebo,
English: Each vial of Nplate 125 micrograms powder for solution for injection contains a total of 230 micrograms of romiplostim.
Slovenian: Ena viala zdravila Nplate 125 mikrogramov prašek za raztopino za injiciranje vsebuje celokupno 230 mikrogramov romiplostima.
English: Patients had a median platelet count of 19 x 10
Slovenian: Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 19 x 10
English: What Nplate contains
Slovenian: Kaj vsebuje zdravilo Nplate
English: • bone marrow failure; disorder of the bone marrow that causes scarring (myelofibrosis); enlarged spleen (splenomegaly); bleeding of the vagina (vaginal haemorrhage), bleeding in the rectum (rectal haemorrhage); bleeding mouth (mouth haemorrhage); injection site bleeding (injection site haemorrhage);
Slovenian: • odpoved kostnega mozga, bolezen kostnega mozga, ki povzroči brazgotinjenje (mielofibroza), povečana vranica (splenomegalija), krvavitev iz nožnice (vaginalna krvavitev), krvavitev iz danke (rektalna krvavitev), krvavitev v ustih, krvavitev na mestu injiciranja,
English: • itching of the skin (pruritis);
Slovenian: • srbenje kože (pruritus),
English: Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection
Slovenian: Nplate 125 mikrogramov prašek za raztopino za injiciranje Nplate 250 mikrogramov prašek za raztopino za injiciranje Nplate 500 mikrogramov prašek za raztopino za injiciranje
English: Across the entire ITP clinical programme an inverse relationship between bleeding events and platelet counts was observed.
Slovenian: V celotnem kliničnem programu ITP so opažali obratno sorazmerje med pojavom krvavitev in številom trombocitov.
English: Dose adjustment guidance based on platelet count
Slovenian: Tabela 2: Navodilo za prilagajanje odmerkov na osnovi števila trombocitov
English: Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
Slovenian: V kombinaciji z romiplostimom (glejte poglavje 5.1) je mogoče uporabo kortikosteroidov, danazola in azatioprina zmanjšati ali prekiniti.
English: • upper respiratory tract infection;
Slovenian: • okužba zgornjih dihal,
English: Patients had a median platelet count of 14 x 10
Slovenian: Ob vključitvi v študijo so imeli bolniki mediano vrednost števila trombocitov 14 x 10
English: • Lift off plastic vial adapter packaging, leaving vial adapter on vial.
Slovenian: • Dvignite plastično ovojnino z nastavka za vialo, tako da ostane nastavek za vialo na viali.
English: If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts.
Slovenian: Če se število trombocitov preveč poveča, prekinite uporabo zdravila Nplate in kontrolirajte število trombocitov.
English: After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC and for 24 hours at 2ºC - 8ºC, when protected from light and kept in the original vial.
Slovenian: Po pripravi: Če je zdravilo zaščiteno pred svetlobo in je v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 24 ur pri temperaturi 25 °C in za 24 ur pri temperaturi od 2 °C do 8 °C.
English: Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC.
Slovenian: Med 77 bolniki, ki so bili randomizirani v skupino s standardno oskrbo, dva bolnika nista prejela standardne oskrbe.
English: Patients with hepatic Impairment
Slovenian: Bolniki z okvaro jeter
English: In a randomised placebo-controlled trial in MDS subjects, treatment with romiplostim was prematurely stopped due to a numerical excess of disease progression to AML and an increase in circulating blasts greater than 10% in patients receiving romiplostim.
Slovenian: V randomiziranem, s placebom kontroliranem preskušanju pri bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim številčni presežek napredovanje bolezni v AML in povečanje števila blastnih celic v obtoku za več kot 10 %.
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Slovenian: Izdelovalec Amgen NV Arianelaan 5 1200 Brussel Belgija
English: The individual patient dose = 75 kg x 1 mcg/kg = 75 mcg
Slovenian: 75 kg x 1 µg/kg = 75 µg
English: In the subset of subjects with ITP > 12 months of duration, the mean (SD) number of composite bleeding episodes was 2.1 (4.7) for the romiplostim arm and 4.2 (7.5) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.0 (0, 4) in the placebo arm. Because the statistical testing for the incidence of rescue medication use was not significant, no statistical test was done for the number of composite bleeding episodes endpoint.
Slovenian: V podskupini bolnikov, ki so imeli ITP > 12 mesecev, je bilo povprečno (SD) število skupne pojavnosti krvavitev 2,1 (4,7) v skupini, ki je prejemala romiplostim, in 4,2 (7,5) v skupini, ki je prejemala placebo, z mediano (Q1, Q3) števila krvavitev 0,0 (0, 2) v skupini, ki je prejemala romiplostim, in 0,0 (0, 4) v skupini, ki je prejemala placebo.
English: 9/L for 4 or more times during study weeks 2-25 but without durable platelet response.
Slovenian: 9/l, ugotovljeno 6- ali večkrat od 18. do 25. tedna študije brez uporabe rešilnih zdravil kadarkoli med zdravljenjem.
English: Action Increase once weekly dose by 1 mcg/kg
Slovenian: Odmerek enkrat na teden povečajte za 1 µg/kg.
English: A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
Slovenian: Pozitivno razmerje koristi in tveganja za romiplostim je vzpostavljeno samo za zdravljenje trombocitopenije, povezane s kronično ITP.