FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of eltrombopag and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution (see section 5.2).
Slovenian: Pri sočasni uporabi eltrombopaga in substratov za OATP1B1 (npr. metotreksat) in BCRP (npr. topotekan in metotreksat) je potrebna previdnost (glejte poglavje 5.2).
English: See also ‘Bleeding or bruising after you stop treatment' in section 4.
Slovenian: Glejte tudi poglavje 4 »Krvavitve ali modrice po prekinitvi zdravljenja«.
English: Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C infection.
Slovenian: Varnost in učinkovitost ni bila ugotovljena pri sočasni uporabi z direktno delujočimi protivirusnimi zdravili, odobrenimi za zdravljenje kroničnih okužb s hepatitisom C.
English: Eltrombopag dose (once daily)
Slovenian: Odmerek eltrombopaga (enkrat na dan)
English: The sudden blocking of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.
Slovenian: Nenadna zamašitev krvne žile s krvnim strdkom je občasen neželen učinek, ki se lahko pojavi pri največ 1 od 100 bolnikov.
English: Read the information ‘Liver problems' in section 4 of this leaflet.
Slovenian: Preberite informacije v poglavju 4 tega navodila za uporabo »Težave z jetri«.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici.
English: • pain, swelling and tenderness in one of your legs (usually the calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
Slovenian: • bolečine, otekanje in povečana občutljivost v eni nogi (običajno v goleni) s toplo kožo nad prizadetim predelom (znaki krvnega strdka v globoki veni)
English: A greater proportion of patients on eltrombopag did not require any antiviral dose reduction as compared to placebo (45% vs. 27%).
Slovenian: Večji delež bolnikov, ki so prejemali eltrombopag, ni potrebovalo zmanjšanja odmerka protivirusnega zdravila glede na placebo (45 % v primerjavi s 27 %).
English: Severe aplastic anaemia in adult patients
Slovenian: Huda aplastična anemija pri odraslih bolnikih
English: • lack of interest, mood changes
Slovenian: • nezainteresiranost, motnje razpoloženja
English: • sudden shortness of breath, especially together with sharp pain in the chest or rapid breathing
Slovenian: • nenaden pojav težkega dihanja, skupaj z ostro bolečino v prsnem košu ali hitro dihanje.
English: Eltrombopag n/N (%) [95% CI]
Slovenian: eltrombopag n/N (%) [95 % IZ]
English: Based on urinary excretion and metabolites eliminated in faeces, the oral absorption of drug-related material following administration of a single 75 mg eltrombopag solution dose was estimated to be at least 52%.
Slovenian: Na osnovi izločanja z urinom in presnovkov, ki se izločijo z blatom ocenjujejo, da je absorpcija z zdravilom povezanega materiala po peroralni uporabi enkratnega 75 mg odmerka raztopine eltrombopaga vsaj 52-odstotna.
English: During treatment with eltrombopag 59% (23/39) became platelet transfusion independent (28 days without platelet transfusion) and 27% (10/37) became RBC transfusion independent (56 days without RBC transfusion).
Slovenian: V času zdravljenja z eltrombopagom je 59 % (23/39) bolnikov doseglo neodvisnost od transfuzij trombocitov (28 dni brez transfuzij trombocitov), 27 % (10/37) bolnikov pa je doseglo neodvisnost od transfuzij eritrocitov (56 dni brez transfuzij eritrocitov).
English: Combination with direct-acting antiviral agents
Slovenian: Sočasna uporaba z direktno delujočimi protivirusnimi zdravili
English: Do not take Revolade
Slovenian: Ne jemljite zdravila Revolade
English: Caution should be exercised in these patients (see section 4.4).
Slovenian: Pri teh bolnikih je potrebna previdnost (glejte poglavje 4.4).
English: Plasma eltrombopag Cmax and AUC(0-) estimates for patients with HCV enrolled in the phase III studies are presented for each dose studied in Table 9.
Slovenian: Ocene Cmax in AUC(0-) plazemskega eltrombopaga za bolnike s HCV vključene v Fazo III študij so predstavljene za vsak odmerek v preglednici 9.
English: Patient platelet count should continue to be monitored and the standard criteria for further dose modification followed.
Slovenian: Pri teh bolnikih je treba kontinuirano nadzirati število trombocitov in upoštevati standardne kriterije za nadaljnje prilagoditve odmerka.
English: • Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Slovenian: • Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, o tem obvestite zdravnika.
English: • problems with the nose, throat and sinuses, breathing problems when sleeping
Slovenian: • težave z nosom, žrelom oziroma grlom in sinusi, težave z dihanjem med spanjem
English: There is a theoretical concern that TPO-R agonists may stimulate the progression of existing haematological malignancies such as MDS.
Slovenian: Obstajajo teoretični pomisleki, da bi lahko agonisti trombopoetinskih receptorjev (agonisti TPO-R) spodbujali napredovanje že prisotne hematološke maligne bolezni, kot je MDS.
English: Prior to initiation of eltrombopag, the peripheral blood smear should be examined closely to establish a baseline level of cellular morphologic abnormalities.
Slovenian: Pred uvedbo zdravljenja z eltrombopagom je treba skrbno pregledati vzorec razmaza periferne krvi, da se ugotovi izhodiščna stopnja celičnih morfoloških nepravilnosti.
English: 6 to 11 years (n=68)
Slovenian: 6 do 11 let (n =68)
English: Tubular toxicity was also observed in a 2-year oral carcinogenicity study in mice at doses of 25, 75 and 150 mg/kg/day.
Slovenian: O toksičnih učinkih za ledvične tubule so poročali tudi pri dveletnih študijah kancerogenosti pri miših pri peroralni uporabi odmerkov 25, 75 in 150 mg/kg/dan.
English: Preparation and administration of the powder for oral suspension:
Slovenian: Priprava in odmerjanje praška za peroralno suspenzijo:
English: In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.
Slovenian: V kliničnih študijah z agonistom TPO-R pri bolnikih z MDS so opazili primere prehodnega povečanja števila blastnih celic in opisali so primere napredovanja MDS v akutno mieloično levkemijo (AML).
English: b p-value a a Logistic regression model adjusted for randomisation stratification variables b 21 out of 63 (33%) patients treated with eltrombopag who were taking an ITP medicinal product at baseline permanently discontinued all baseline ITP medicinal products.
Slovenian: b vrednost p a a Logistični regresijski model, prilagojen za randomizacijske stratificirane spremenljivke b Pri 21 od 63 (33 %) bolnikov, ki so se zdravili z eltrombopagom, in so v izhodišču uporabljali zdravila za zdravljenje ITP, je bilo zdravljenje z vsemi izhodiščnimi zdravili za zdravljenje ITP trajno prekinjeno.
English: • some mineral and vitamin supplements including iron, calcium, magnesium, aluminium,
Slovenian: • nekaterih mineralnih in vitaminskih prehranskih dopolnil, ki vsebujejo železo, kalcij,
English: For ENABLE 1, 682 patients were randomised to the antiviral treatment phase; however 2 patients then withdrew consent prior to receiving antiviral therapy d p-value <0.05 for eltrombopag versus placebo e 64% patients participating in ENABLE 1 and ENABLE 2 were genotype 1 f Post-hoc analyses
Slovenian: Pri ENABLE 1 je bilo 1682 bolnikov randomiziranih v fazo protivirusnega zdravljenja; vendar sta 2 bolnika odstopila pred začetkom protivirusnega zdravljenja d vrednost P <0,05 za eltrombopag glede na placebo e 64 % bolnikov, ki so sodelovali v ENABLE 1 in ENABLE 2 so bili genotip 1 f naknadne analize
English: QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Slovenian: O podaljšanju intervala QTc so poročali v kliničnih študijah pri bolnikih z ITP in trombocitopeničnih bolnikih z HCV.
English: In the pre-antiviral treatment phase, patients received open-label eltrombopag to increase the platelet count to ≥90,000/µl for ENABLE 1 and ≥100,000/µl for ENABLE 2.
Slovenian: V prvi fazi brez protivirusnega zdravljenja so bolniki odprto prejemali eltrombopag za povečanje števila trombocitov do ≥90.000/µl pri ENABLE 1 in do ≥100.000/µl pri ENABLE 2.
English: Symptoms include: - black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people) - blood in your stools - vomiting blood or something that looks like coffee grounds
Slovenian: Simptomi lahko vključujejo: - črno katranasto blato (spremenjena barva blata je občasen neželen učinek in se lahko pojavi pri največ 1 od 100 bolnikov) - kri v blatu - bruhanje krvi ali vsebine, ki je podobna kavni usedlini.
English: Bleeding following discontinuation of eltrombopag
Slovenian: Krvavitve po prekinitvi zdravljenja z eltrombopagom
English: Revolade can cause blood test results that may be signs of liver damage - an increase of some liver enzymes, especially bilirubin and alanine / aspartate transaminases.
Slovenian: Zaradi zdravljenja z zdravilom Revolade lahko izvidi krvnih preiskav pokažejo okvaro jeter - lahko se zviša vrednost nekaterih jetrnih encimov v krvi, še posebno bilirubina in alanin-/aspartataminotransferaze.
English: The lowest dose of eltrombopag needed to achieve the targets should be used.
Slovenian: Potrebno je uporabiti najmanjši odmerek eltrombopaga, da se doseže cilj.
English: The safety of Revolade in paediatric patients (aged 1 to 17 years) with previously treated ITP has been demonstrated in two studies.
Slovenian: Varnost uporabe zdravila Revolade pri pediatričnih bolnikih (starih od 1 do 17 let) s predhodno zdravljeno ITP so dokazali v dveh študijah.
English: If the use of eltrombopag is deemed necessary for ITP patients with hepatic impairment the starting dose must be 25 mg once daily.
Slovenian: Če je uporaba eltrombopaga potrebna pri bolnikih z ITP, ki imajo okvaro jeter, mora biti začetni odmerek 25 mg enkrat na dan.
English: The remaining 10 patients had insufficient platelet response to prior therapies.
Slovenian: Pri preostalih 10 bolnikih pri predhodnih zdravljenjih ni prišlo do zadostnega odziva glede povečanja števila trombocitov.
English: Treatment with eltrombopag in these patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention.
Slovenian: Zdravljenje z eltrombopagom lahko začnejo samo tisti zdravniki, ki imajo izkušnje z obvladovanjem napredovale HCV in samo takrat, ko je intervencija potrebna zaradi tveganja za trombocitopenijo ali prekinitve protivirusnega zdravljenja.
English: Furthermore, a clinical pharmacology study in 36 subjects showed no evidence that photosensitivity was increased following administration of eltrombopag 75 mg.
Slovenian: Klinična farmakološka študija pri 36 osebah je pokazala, da se po uporabi eltrombopaga v odmerku 75 mg fotosenzitivnost ni povečala.
English: After initiating eltrombopag, the dose must be adjusted to achieve and maintain a platelet count ≥50,000/µl as necessary to reduce the risk for bleeding.
Slovenian: Po uvedbi zdravljenja z eltrombopagom je treba odmerek prilagoditi tako, da se doseže in vzdržuje število trombocitov ≥50.000/µl, kar je potrebno za zmanjšanje tveganja za pojav krvavitev.
English: Haematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting eltrombopag (see section 5.1).
Slovenian: Glede na hematološki odziv je treba odmerek titrirati, večinoma do 150 mg, kar lahko traja do 16 tednov od začetka zdravljenja z eltrombopagom (glejte poglavje 5.1).
English: • fast or irregular heartbeat (palpitations), shortness of breath
Slovenian: • hiter ali nepravilen srčni utrip (palpitacije), zadihanost
English: In the HCV studies the safety population consisted of all randomised patients who received double-blind study medicinal product during Part 2 of ENABLE 1 (Revolade treatment n=450, placebo treatment n=232) and ENABLE 2 (Revolade treatment n=506, placebo treatment n=253).
Slovenian: V študijah s HCV so populacijo za oceno varnosti predstavljali vsi randomizirani bolniki, ki so dvojno slepo prejemali študijsko zdravilo v 2. delu študije ENABLE 1 (zdravilo Revolade n=450, placebo n=232) in v študiji ENABLE 2 (zdravilo Revolade n=506, placebo n=253).
English: • in the 4 hours before you take Revolade
Slovenian: • 4 ure preden vzamete zdravilo Revolade,
English: Statistically fewer eltrombopag patients required rescue treatment during the randomised period compared to placebo patients (19% [12/63] vs. 24% [7/29], p=0.032).
Slovenian: V obdobju randomiziranega zdravljenja je rešilno zdravljenje potrebovalo statistično značilno manj bolnikov z eltrombopagom v primerjavi z bolniki s placebom (19 % [12/63] v primerjavi s 24 % [7/29], p = 0,032).
English: Cohort 2 (6 to 11 years)
Slovenian: skupina 2 (6 do 11 let)
English: Very common side effects that may show up in blood tests: • increased of liver enzymes (alanine aminotransferase (ALT))
Slovenian: Zelo pogosti neželeni učinki, ki se pokažejo v izvidih krvnih preiskav: • zvišane vrednosti jetrnih encimov (alanin aminotransferaze (ALT))
English: Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans.
Slovenian: Eltrombopag pri uporabi v odmerku 75 mg enkrat na dan v trajanju 7 dni pri 24 zdravih prostovoljcih moškega spola ni zaviral ali induciral presnove preizkusnih substratov za 1A2 (kofein), 2C19 (omeprazol), 2C9 (flurbiprofen) ali 3A4 (midazolam).
English: • heavy menstrual period
Slovenian: • močne menstrualne krvavitve
English: Patients are analysed according to the treatment received (total safety double-blind population, Revolade n=955 and placebo n=484).
Slovenian: Podatke bolnikov so analizirali glede na to, katero vrsto zdravljenja so prejemali (celotna populacija za oceno varnosti, zdravljena na dvojno slep način: zdravilo Revolade n=955 in placebo n=484).
English: Platelet counts should be monitored every week prior to starting antiviral therapy.
Slovenian: Število trombocitov je potrebno spremljati vsak teden pred začetkom protivirusnega zdravljenja.
English: Co-administration of a single dose of eltrombopag 200 mg with boceprevir 800 mg every 8 hours did not alter plasma boceprevir AUC(0-), but increased Cmax by 20%, and decreased Cmin by 32%.
Slovenian: Pri sočasni uporabi enkratnega 200 mg odmerka eltrombopaga z 800 mg boceprevirja vsakih 8 ur se plazemska AUC(0-) boceprevirja ni spremenila, se je pa povečala Cmax za 20 % in zmanjšala Cmin za 32 %.
English: There was substantial variability and significant overlap in exposures between patients with renal impairment and healthy volunteers.
Slovenian: Opazili so znatno variabilnost in pomembno prekrivanje pri izpostavljenosti zdravilu med bolniki z okvaro ledvic in zdravimi prostovoljci.
English: • and the 2 hours after you take Revolade you don't consume any of the following:
Slovenian: • in 2 uri po tem, ko vzamete zdravilo Revolade,
English: If you don't use the medicine within 30 minutes of mixing it, you will need to mix a new dose.
Slovenian: Če zdravila ne uporabite v 30 minutah od takrat, ko ga zmešate, si morate pripraviti nov odmerek.
English: Sustained response was seen in 50% of the initial responders during 20 out of 24 weeks in the PETIT 2 study and 15 out of 24 weeks in the PETIT Study.
Slovenian: Ohranjanje odziva so opažali pri 50 % tistih bolnikov, pri katerih je do odziva prišlo, in sicer v študiji PETIT 2 v 20 od 24 tednov in v študiji PETIT v 15 od 24 tednov.
English: The diagnosis of ITP or SAA in adults and elderly patients should be confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Slovenian: Diagnoza ITP ali hude aplastične anemije pri odraslih in starejših bolnikih mora biti potrjena z izključitvijo drugih kliničnih stanj, povezanih s trombocitopenijo, še zlasti je treba izključiti MDS.
English: • decreased number of eosinophils
Slovenian: • znižano število eozinofilcev
English: It is not known whether Revolade passes into breast-milk.
Slovenian: Ni znano, če se zdravilo Revolade izloča z materinim mlekom.
English: In vitro studies also demonstrated that eltrombopag is a breast cancer resistance protein (BCRP) substrate and inhibitor (IC50 value of 2.7 μM (1.2 μg/ml).
Slovenian: In vitro študije so tudi pokazale, da je eltrombopag substrat in zaviralec proteina odpornosti za raka dojke BCRP z inhibitorno koncentracijo IC50 2,7 μM (1,2 μg/ml).
English: Platelet count response between 50,000-400,000/l in the absence of rescue treatment was achieved by significantly more patients in the eltrombopag treated group during the 6 month treatment period, p <0.001.
Slovenian: Odziv v obliki števila trombocitov med 50.000-400.000/l brez uporabe rešilnega zdravljenja je bil dosežen pri pomembno večjem številu bolnikov, ki so med 6 mesečnim obdobjem zdravljenja prejemali eltrombopag, p <0,001.
English: Cytochrome P450 substrates
Slovenian: Substrati za citokrom P450
English: Eltrombopag was detected in the plasma of all F1 rat pups for the entire 22 hour sampling period following administration of medicinal product to the F0 dams, suggesting that rat pup exposure to eltrombopag was likely via lactation.
Slovenian: Pri podganah je bil eltrombopag prisoten v plazmi vseh F1 mladičev celotno 22-urno obdobje jemanja vzorcev po uporabi zdravila pri F0 materah, kar kaže, da je bila izpostavljenost podganjih mladičev eltrombopagu verjetno posledica dojenja.
English: The objective of treatment with eltrombopag should not be to normalise platelet counts.
Slovenian: Cilj zdravljenja z eltrombopagom ne sme biti normalizacija števila trombocitov.
English: After section 6 of this leaflet there are Instructions For Use on how to mix and administer the medicine.
Slovenian: V poglavju 6 v tem besedilu boste pod naslovom Navodila za uporabo našli navodila za pripravo (mešanje) in odmerjanje zdravila.
English: During antiviral therapy, the dose of eltrombopag should be adjusted as necessary to avoid dose reductions of peginterferon due to decreasing platelet counts that may put patients at risk of bleeding (see Table 2).
Slovenian: Med protivirusnim zdravljenjem se odmerek eltrombopaga prilagaja po potrebi, da se izognemo zmanjšanju odmerka peginterferona zaradi zmanjšanja števila trombocitov, ki lahko pri bolnikih privede do nevarnosti za krvavitve (glejte preglednico 2).
English: There was substantial variability and significant overlap in exposures between patients with hepatic impairment and healthy volunteers.
Slovenian: Opazili so znatno variabilnost in pomembno prekrivanje pri izpostavljenosti zdravilu med bolniki z okvaro jeter in zdravimi prostovoljci.
English: Immune (primary) thrombocytopenia (ITP) studies
Slovenian: Študije imunske (primarne) trombocitopenije (ITP)
English: Eltrombopag is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures.
Slovenian: Eltrombopag ni indiciran za zdravljenje trombocitopenije pri bolnikih s kronično jetrno boleznijo in v sklopu priprav na invazivne posege.
English: Keep Revolade powder for oral suspension, including the dosing kit, and all medicines out of the reach of children.
Slovenian: Revolade prašek za peroralno suspenzijo skupaj s kompletom za odmerjanje in vsa zdravila shranjujte nedosegljivo otrokom.
English: Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Slovenian: Zdravili Revolade 12,5 mg in 25 mg filmsko obložene tablete vsebujeta še polisorbat 80 (E433).
English: Administration of eltrombopag concomitantly with antacids and other products containing polyvalent cations such as dairy products and mineral supplements significantly reduces eltrombopag exposure (see section 4.2).
Slovenian: Pri uporabi eltrombopaga skupaj z antacidi in drugimi izdelki, ki vsebujejo polivalentne katione, kot so živila mlečnega izvora in mineralna prehranska dopolnila, se izpostavljenost eltrombopagu pomembno zmanjša (glejte poglavje 4.2).
English: What you need Each Revolade powder for oral suspension kit contains:
Slovenian: Kaj potrebujete En komplet za odmerjanje praška za peroralno suspenzijo zdravila Revolade vključuje:
English: • increased levels of alkaline phosphatase
Slovenian: • zvišana vrednost alkalne fosfataze
English: Platelet counts should be closely monitored.
Slovenian: Število trombocitov je treba skrbno nadzirati.
English: Revolade may take 1 to 2 weeks to work.
Slovenian: Učinek zdravila Revolade se lahko pokaže šele 1 do 2 tedna po začetku zdravljenja.
English: During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/µl for at least 4 weeks) has been achieved.
Slovenian: Med zdravljenjem z eltrombopagom je treba tedensko opravljati preiskave celotne krvne slike, vključno s številom trombocitov in razmazi periferne krvi, dokler ni doseženo stabilno število trombocitov (≥50.000/µl za najmanj 4 tedne).
English: Revolade 12.5 mg, 25 mg, 50 mg and 75 mg film-coated tablets:
Slovenian: Revolade 12,5 mg, 25 mg, 50 mg in 75 mg filmsko obložene tablete:
English: Initial dose regimen
Slovenian: Režim začetnega odmerjanja
English: Don't stop taking Revolade without talking to your doctor.
Slovenian: Zdravila Revolade ne smete nehati jemati, ne da bi se o tem prej posvetovali z zdravnikom.
English: The median time to diagnosis was 3 months from the start of eltrombopag treatment.
Slovenian: Mediani čas od začetka zdravljenja z eltrombopagom do postavitve diagnoze je bil 3 mesece.
English: Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
Slovenian: V primerjavi z zdravimi prostovoljci so imeli bolniki z blago okvaro jeter za približno 111 % (95 % CI: 45 % do 283 %) večje vrednosti AUC(0-) eltrombopaga v plazmi in bolniki z zmerno okvaro jeter pa približno 183 % (95 % CI: 90 % to 459 %).
English: The predominant route of eltrombopag excretion is via faeces (59%) with 31% of the dose found in the urine as metabolites.
Slovenian: Eltrombopag se pretežno izloča z blatom (59 %), 31 % odmerka je prisotnega v urinu v obliki presnovkov.
English: The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Slovenian: Druge sestavine zdravila so: hipromeloza, makrogol 400, magnezijev stearat, manitol (E421), mikrokristalna celuloza, povidon, natrijev karboksimetilškrob in titanov dioksid (E171).
English: Your doctor will check your platelet count for at least 4 weeks after you stop taking Revolade.
Slovenian: Zdravnik bo število trombocitov nadziral še najmanj štiri tedne po prekinitvi zdravljenja z zdravilom Revolade.
English: In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between patients aged at least 65 years and younger patients.
Slovenian: V kliničnih študijah, izvedenih z eltrombopagom, se varnost uporabe eltrombopaga pri bolnikih, starih vsaj 65 let, v celoti klinično ni pomembneje razlikovala od varnosti pri mlajših bolnikih.