FrancophonIA/ELRC3.0 huggingface dataset:
English: Both studies enrolled paediatric subjects (≥ 1 year to < 18 years of age) with thrombocytopenia (defined by a mean of 2 platelet counts ≤ 30 x 109/L with neither count > 35 x 109/L in both studies) with ITP, regardless of splenectomy status.
Slovenian: V obe preskušanji so bili vključeni pediatrični bolniki (stari ≥ 1 leto do < 18 let) s trombocitopenijo (definirano kot povprečje dveh vrednosti števila trombocitov ≤ 30 x 10
English: If the calculated individual patient dose is less than 23 mcg, 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, 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 točnega volumna (glejte tabelo spodaj).
English: Sterile water for injections only should be used when reconstituting the medicinal product.
Slovenian: Za pripravo zdravila smete uporabiti le sterilno vodo za injekcije.
English: 125 mcg/mL
Slovenian: 125 µg/ml
English: • Do make sure that all air bubbles are removed before injection.
Slovenian: • Pred injiciranjem preverite, da so vsi zračni mehurčki odstranjeni.
English: In adult clinical studies of treatment with romiplostim in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to AML were reported.
Slovenian: V kliničnih preskušanjih zdravljenja odraslih bolnikov z romiplostimom pri bolnikih z MDS so opazili primere prehodnega povečanja števila blastnih celic in poročali tudi o primerih napredovanja bolezni iz MDS v AML.
English: Vial containing 125 micrograms of romiplostim.
Slovenian: Ena viala vsebuje 125 mikrogramov romiplostima.
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).
Slovenian: Celokupno je v skupini bolnikov, ki so prejemali romiplostim, značilno večji delež bolnikov dosegel primarni opazovani dogodek v primerjavi z bolniki, ki so prejemali placebo (p = 0,0018).
English: In clinical studies of treatment with romiplostim in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to AML were reported.
Slovenian: V kliničnih preskušanjih zdravljenja z romiplostimom pri bolnikih z MDS so opazili primere prehodnega povečanja števila blastnih celic in poročali tudi o primerih napredovanja bolezni iz MDS v AML.
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.
Slovenian: Rezultati študij v primerjavi s standardno oskrbo pri nesplenektomiranih bolnikih Študija S3 (131) je bila odprto randomizirano 52-tedensko preskušanje pri odraslih bolnikih, ki so prejemali zdravljenje z romiplostimom ali s standardno zdravstveno oskrbo.
English: Vaginal haemorrhage
Slovenian: ZUNANJA OVOJNINA
English: Dose calculator
Slovenian: Kalkulator odmerka
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).
Slovenian: Pri podganah, ki so dobile posamičen odmerek 1.000 µg/kg, in opicah po večkratni uporabi 500 µg/kg romiplostima (prvo je 100-kratni, drugo pa 50-kratni največji klinični odmerek 10 µg/kg) niso ugotovili neželenih učinkov.
English: Cases of thromboembolic events (TEEs), including portal vein thrombosis, have been reported in patients with chronic liver disease receiving romiplostim.
Slovenian: Pri bolnikih s kronično boleznijo jeter, ki so prejemali romiplostim, so bili opisani primeri tromboemboličnih dogodkov, vključno s trombozo portalne vene.
English: Similar reduction of the subject prevalence of rescue medication over the course of the study was seen in the subset of subjects with ITP > 12 months of duration: from 25.4% (weeks 1 to 12) to ≤ 13.1% (weeks 13 to 216), then 0% after week 216 until the end of the study.
Slovenian: Podobno zmanjševanje prevalence uporabe rešilnega zdravila v času študije je bilo opaženo v podskupini bolnikov, ki so imeli ITP > 12 mesecev: od 25,4 % (1. do 12. teden) do ≤ 13,1 % (13. do 216. teden) in nato 0 % od tedna 216 do konca preskušanja.
English: You should speak with your doctor before driving or using machines, as some side effects (e.g. temporary bouts of dizziness) may impair your ability to do so safely.
Slovenian: Nekateri neželeni učinki (npr. prehodni pojavi omotice) namreč lahko poslabšajo vašo sposobnost za varno izvajanje teh dejavnosti.
English: Turn assembled syringe-vial unit upside down, so the vial of reconstituted product is above the syringe.
Slovenian: Obrnite sestavljeno enoto brizga-viala na glavo, tako da je viala s pripravljenim zdravilom nad brizgo.
English: From a microbiological point of view, the diluted medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča je razredčeno zdravilo treba uporabiti takoj.
English: Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim.
Slovenian: Po prenehanju zdravljenja z romiplostimom je verjeten ponoven pojav trombocitopenije.
English: A significantly higher proportion of patients receiving romiplostim achieved a durable platelet response compared to patients receiving placebo in both studies.
Slovenian: V obeh študijah je trajen odziv trombocitov dosegel znatno večji delež bolnikov, ki so prejemali zdravilo Nplate, kot tistih, ki so prejemali placebo.
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.
Slovenian: Zvišanje retikulina v kostnem mozgu velja za posledico stimulacije receptorjev TPO.
English: Monitoring of these parameters should be considered in patients treated with romiplostim.
Slovenian: Bolnikom, ki dobivajo romiplostim, je priporočljivo kontrolirati te vrednosti.
English: • bruising (contusion);
Slovenian: • podplutbe (kontuzija),
English: • problems with the digestive system including: vomiting; bad breath (breath odour); difficulty swallowing (dysphagia); indigestion or heartburn (gastro-oesophageal reflux disease); blood in the stools (haematochezia); stomach discomfort; mouth ulcers or mouth blistering (stomatitis); discoloured teeth (tooth discolouration);
Slovenian: • težave s prebavili, med njimi: bruhanje, zadah iz ust, težave s požiranjem (disfagija), prebavne motnje ali zgaga (gastroezofagealna refluksna bolezen), kri v blatu (hematohezija), nelagodje v želodcu, razjede v ustih ali mehurji v ustih (stomatitis), obarvanje zob,
English: Hypoaesthesia Hypogeusia Neuropathy peripheral Transverse sinus thrombosis
Slovenian: Bolezni živčevja glavobol omotica migrena parestezije klonus dizgevzija hipoestezija hipogevzija periferna nevropatija tromboza tranzverzalnega sinusa
English: Attach plunger rod to the pre-filled syringe of water for injections by twisting the plunger rod clockwise onto the syringe plunger, until you feel a slight resistance.
Slovenian: Namestite držalo bata na napolnjeno injekcijsko brizgo z vodo za injekcije, in sicer tako, da držalo v smeri urnega kazalca privijate na bat brizge, dokler ne začutite rahlega upora.
English: Self-administration of Nplate is not allowed for paediatric patients.
Slovenian: Pediatrični bolniki si zdravila Nplate ne smejo aplicirati sami.
English: Rectal haemorrhage Breath odour Dysphagia Gastro-oesophageal reflux disease Haematochezia Mouth haemorrhage Stomach discomfort Stomatitis
Slovenian: navzea driska bolečine v trebuhu zaprtost dispepsija bruhanje rektalna krvavitev halitoza disfagija gastroezofagealna refluksna bolezen hematohezija krvavitev v ustih nelagodje v želodcu stomatitis obarvanje zob
English: • swelling in the hands and feet (oedema peripheral);
Slovenian: • oteklost rok in nog (periferni edemi),
English: In the two adult placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)).
Slovenian: V dveh placebo kontroliranih preskušanjih odraslih bolnikov je 9 bolnikov poročalo o krvavitvi, ki je bila ocenjena kot resna (5 [6,0 %] romiplostim, 4 [9,8 %] placebo; razmerje obetov [romiplostim/placebo] = 0,59; 95 % IZ = (0,15, 2,31)).
English: Nplate should be injected once per week in order to keep your platelet counts up.
Slovenian: Zdravilo Nplate je treba za vzdrževanje večjega števila trombocitov injicirati enkrat na teden.
English: In the two placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)).
Slovenian: V dveh s placebom kontroliranih študijah je pri 9 bolnikih prišlo do krvavitve, ki je bila ocenjena za resno (5 [6,0 %] romiplostim, 4 [9,8 %] placebo, razmerje obetov [romiplostim/placebo] = 0,59; 95 % IZ = (0,15, 2,31)).
English: 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 30 dni pri sobni temperaturi (do 25 °C).
English: Platelet counts above the normal range present a risk for thrombotic/thromboembolic complications.
Slovenian: Zvišano število trombocitov pomeni tveganje za trombotične/tromboembolične zaplete.
English: Dilution Guidelines:
Slovenian: Navodilo za redčenje:
English: A subject's actual body weight at initiation of therapy should be used to calculate dose.
Slovenian: Za izračun odmerka morate uporabiti bolnikovo dejansko telesno maso na začetku zdravljenja.
English: Concentration after dilution
Slovenian: Koncentracija po redčenju
English: Injection safety needle x1
Slovenian: 1 x varnostno iglo za injiciranje
English: Talk to your doctor, pharmacist or nurse before using Nplate.
Slovenian: Pred začetkom uporabe zdravila Nplate se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Prepare sterile water syringe
Slovenian: 3. korak: Priprava brizge s sterilno vodo
English: • Do make sure liquid is fully dissolved before removing syringe.
Slovenian: • Preden odstranite brizgo, se prepričajte, da je zdravilo v tekočini povsem raztopljeno.
English: • fever (pyrexia);
Slovenian: • zvišana telesna temperatura (pireksija),
English: Do make sure solution is fully dissolved before removing syringe.
Slovenian: Preden odstranite brizgo, se prepričajte, da je zdravilo v raztopini povsem raztopljeno.
English: Nplate 125 micrograms powder for solution for injection
Slovenian: Nplate 125 mikrogramov prašek za raztopino za injiciranje
English: Preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection only must be used for dilution.
Slovenian: Za redčenje uporabite le sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje brez dodanih konzervansov.
English: No statistically significant differences in the overall incidence of bleeding events were observed between Nplate and placebo treated patients.
Slovenian: Med bolniki, zdravljenimi z zdravilom Nplate, in bolniki, zdravljenimi s placebom, niso opazili statistično pomembnih razlik v celokupni incidenci krvavitev.
English: Muscle tightness Muscular weakness Shoulder pain Muscle twitching
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija mialgija spazmi mišic bolečina v okončini bolečine v hrbtu bolečine v kosteh napetost mišic šibkost mišic bolečina v rami trzanje mišic
English: EU/1/08/497/006 - 1 pack
Slovenian: EU/1/08/497/006 - 1 pakiranje
English: The subject prevalence of rescue medication use showed a trend towards a reduction over the course of the study: from 24.6% (weeks 1 to 12) to < 13.0% (weeks 13 to 216), then 0% after week 216 until the end of the study.
Slovenian: Prevalenca uporabe rešilnega zdravila je kazala trend zmanjševanja v času preskušanja; od 24,6 % (1. do 12. teden) do < 13,0 % (13. do 216. teden) in nato 0 % od tedna 216 do konca preskušanja.
English: Pulmonary embolism*
Slovenian: Bolezni imunskega sistema preobčutljivost**
English: 1 plunger rod for pre-filled syringe.
Slovenian: 1 držalo bata za napolnjeno injekcijsko brizgo.
English: • Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL.
Slovenian: • Zdravilo Nplate 500 mikrogramov prašek za raztopino za injiciranje je treba pripraviti z 1,2 ml sterilne vode za injekcije, s čimer dobimo 1 ml uporabne količine.
English: - Keep this leaflet.
Slovenian: • Previdno vrtite vialo.
English: Study S3 (131) was an open-label randomised 52 week trial in subjects who received romiplostim or medical standard of care (SOC) treatment.
Slovenian: Rezultati študij v primerjavi s standardno oskrbo pri nesplenektomiranih bolnikih Študija S3 (131) je bila odprto randomizirano 52-tedensko preskušanje pri bolnikih, ki so prejemali zdravljenje z romiplostimom ali s standardno zdravstveno oskrbo.
English: Romiplostim pharmacokinetics appear not affected by age, weight and gender to a clinically significant extent.
Slovenian: Starost, telesna masa in spol po vsem sodeč nimajo klinično pomembnega vpliva na farmakokinetiko romiplostima.
English: Prepare injection site with a new alcohol swab.
Slovenian: Z novim alkoholnim zložencem pripravite mesto za injiciranje.
English: • Attach 1 mL syringe to vial adapter of the dissolved Nplate by twisting the syringe tip clockwise onto the vial adapter until you feel a slight resistance.
Slovenian: • Namestite 1 ml brizgo na nastavek za vialo raztopljenega zdravila Nplate tako, da konico brizge v smeri urinega kazalca zasučete v nastavek za vialo, dokler ne začutite rahlega upora.
English: Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection
Slovenian: Nplate 250 mikrogramov prašek in vehikel za raztopino za injiciranje Nplate 500 mikrogramov prašek in vehikel za raztopino za injiciranje
English: An additional overfill is included in each vial to ensure that 125 micrograms of romiplostim can be delivered.
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 125 mikrogramov romiplostima.
English: 375 mcg
Slovenian: 375 µg
English: For the storage condition after dilution of the reconstituted medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja po redčenju rekonstituiranega zdravila glejte poglavje 6.3.
English: • headache;
Slovenian: • glavobol,
English: (≥ 50 x 10
Slovenian: (95 % IZ)
English: = 125 mcg in 0.25 mL 500 mcg/mL
Slovenian: = 125 µg v 0,25 ml
English: The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 30.8% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Slovenian: Prevalenca sočasne uporabe zdravil za ITP je kazala trend zmanjševanja v obdobju študije: od 30,8 % (1. do 12. teden) do < 20,0 % (13. do 240. teden) in nato 0 % od tedna 240 do konca preskušanja.
English: Vomiting
Slovenian: Trombocitoza
English: • rash;
Slovenian: • driska,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Slovenian: POSTOPEK IN POT UPORABE ZDRAVILA
English: Prepare vial for use, attach vial adapter
Slovenian: 2. korak: Priprava viale za uporabo, namestitev nastavka za vialo
English: Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Slovenian: Amgen NV Arianelaan 5 1200 Brussel Belgija
English: • indigestion (dyspepsia);
Slovenian: • šibkost (astenija),
English: • nausea;
Slovenian: • bolečine,
English: • Common: may affect up to 1 in 10 people
Slovenian: • Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: • low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia)
Slovenian: • nizko število trombocitov (trombocitopenija) in nizko število trombocitov (trombocitopenija) po prenehanju uporabe zdravila Nplate,
English: Attach safety needle to the filled administration syringe by twisting needle clockwise into syringe Luer lock tip.
Slovenian: To naredite tako, da iglo v smeri urnega kazalca zasučete na konico nastavka Luer na brizgi.
English: An additional overfill is included in each vial to ensure that 125 mcg of romiplostim can be delivered (see vial content table below).
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 125 µg romiplostima (glejte tabelo Vsebina viale spodaj).
English: • redness of the skin (flushing);
Slovenian: • pordelost kože (zardevanje),
English: = 250 mcg in 0.50 mL 500 mcg/mL
Slovenian: = 250 µg v 0,50 ml 500 µg/ml
English: An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered (see vial content table below).
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 µg romiplostima (glejte tabelo Vsebina viale spodaj).
English: • Visually confirm that the needle tip is covered.
Slovenian: • Poglejte in se prepričajte, da je konica igle pokrita.
English: • Once the seal is broken, pull the white plastic cover off. You will see grey rubber in the cap.
Slovenian: • Ko je zapečaten del prelomljen, snemite dol bel plastični pokrovček.
English: EU/1/08/497/008 - 1 pack
Slovenian: EU/1/08/497/008 - 1 pakiranje
English: • Wipe the site where Nplate is to be injected with an alcohol swab, using a circular motion.
Slovenian: • Z novim alkoholnim zložencem s krožnim gibom obrišite mesto, kamor boste injicirali zdravilo Nplate.
English: An additional overfill is included in each vial to ensure that 500 mcg of romiplostim can be delivered (see vial content table below).
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 µg romiplostima (glejte tabelo Vsebina viale spodaj).
English: - The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Slovenian: - Druge sestavine zdravila so manitol (E421), saharoza, L-histidin, klorovodikova kislina (za prilagoditev pH) in polisorbat 20.
English: In a randomised placebo-controlled trial in MDS adult subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo.
Slovenian: V randomiziranem, s placebom kontroliranem preskušanju pri odraslih bolnikih z MDS so zdravljenje z romiplostimom predčasno končali, ker so imeli bolniki, ki so prejemali romiplostim, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
English: An additional overfill is included in each vial to ensure that 500 micrograms of romiplostim can be delivered.
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 500 mikrogramov romiplostima.
English: 500 mcg/mL
Slovenian: 500 µg/ml
English: • Do dispose of any left-over Nplate in proper waste container.
Slovenian: • Zavrzite morebitni preostanek zdravila Nplate v ustrezen vsebnik za odpadke.
English: = 500 mcg in 1.00 mL 500 mcg/mL
Slovenian: = 500 µg v 1,00 ml 500 µg/ml
English: Solvent for Nplate Water for injections
Slovenian: Vehikel za zdravilo Nplate voda za injekcije
English: Vial containing 500 micrograms of romiplostim.
Slovenian: Ena viala vsebuje 500 mikrogramov romiplostima.
English: Romiplostim serum levels appear inversely related to platelet counts.
Slovenian: Koncentracija romiplostima v serumu je obratno sorazmerna številu trombocitov.
English: Withdraw all of the medicinal product solution into the administration syringe.
Slovenian: Izvlecite vso raztopino zdravila v brizgo za injiciranje.
English: The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/or discolouration are observed.
Slovenian: Pred uporabo morate raztopino pregledati in se prepričati, da ne vsebuje delcev in ni obarvana.
English: • When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Slovenian: • Ko je brizga prazna, iglo izvlecite iz kože.
English: Nplate 250 micrograms powder for solution for injection
Slovenian: Nplate 250 mikrogramov prašek za raztopino za injiciranje
English: How to store Nplate
Slovenian: Shranjevanje zdravila Nplate
English: c Number of weeks with platelet response is defined as number of weeks with platelet counts ≥ 50 x 109/L during study weeks 2-25.
Slovenian: Prehodni odziv trombocitov je bil opredeljen kot tedensko število trombocitov ≥ 50 x 109/l, ugotovljeno 4- ali večkrat od 2. do 25. tedna, a brez trajnega odziva.
English: An additional overfill is included in each vial to ensure that 250 micrograms of romiplostim can be delivered.
Slovenian: Vsaka viala vsebuje dodatno prepolnjenje, ki zagotavlja, da je mogoče iz nje dobiti 250 mikrogramov romiplostima.
English: In a randomised placebo-controlled trial in MDS subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo.
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, v primerjavi z bolniki, ki so prejemali placebo, povečanje števila primerov napredovanja bolezni iz MDS v AML in prehodna povečanja števila blastnih celic.
English: Portal vein thrombosis Increase in transaminase
Slovenian: Bolezni jeter, žolčnika in žolčevodov tromboza portalne vene zvišanje transaminaz
English: Vial containing 250 micrograms of romiplostim.
Slovenian: Ena viala vsebuje 250 mikrogramov romiplostima.
English: SC
Slovenian: c
English: Eye disorder Eye pruritus Lacrimation increased Papilloedema Visual disturbances
Slovenian: Očesne bolezni konjunktivalna krvavitev motnja akomodacije slepota očesne težave srbenje oči močnejše solzenje papiledem motnje vida
English: Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni okužba zgornjega respiratornega trakta gastroenteritis gripa lokalizirana okužba nazofaringitis
English: EU/1/08/497/005 - 1 pack EU/1/08/497/006 - 4 pack
Slovenian: EU/1/08/497/005 - 1 pakiranje EU/1/08/497/006 - 4 pakiranja
English: 1 mL Luer-lock tip syringe x1
Slovenian: 1 sterilno 1 ml brizgo z nastavkom Luer 1 sterilno varnostno iglo
English: After dilution: Chemical and physical in-use stability has been demonstrated for 4 hours at 25ºC when the diluted product was held in a disposable syringe, or 4 hours in a refrigerator (2ºC - 8ºC) when the diluted product was held in the original vial.
Slovenian: Če je redčeno zdravilo shranjeno v originalni viali, sta kemična in fizikalna stabilnost med uporabo dokazani za 4 ure v hladilniku (2 °C do 8 °C).
English: Aplastic anaemia Bone marrow failure Leucocytosis Splenomegaly Thrombocythaemia Platelet count increased
Slovenian: Bolezni krvi in limfatičnega sistema motnja kostnega mozga* trombocitopenija* anemija aplastična anemija odpoved kostnega mozga levkocitoza splenomegalija trombocitemija povečano število trombocitov nenormalno število trombocitov
English: The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 31.7% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Slovenian: Prevalenca sočasne uporabe zdravil za ITP je kazala trend zmanjševanja v času preskušanja; od 31,7 % (1. do 12. teden) do < 20,0 % (13. do 240. teden) in nato 0 % od tedna 240 do konca preskušanja.