FrancophonIA/ELRC3.0 huggingface dataset:
English: The standard eltrombopag dose adjustment, either decrease or increase, would be 25 mg once daily.
Slovenian: Standardna prilagoditev odmerka eltrombopaga, bodisi zmanjšanje bodisi povečanje, je 25 mg enkrat na dan.
English: However blood clots can also form with normal or even low platelet counts.
Slovenian: Krvni strdki pa lahko nastajajo tudi v primeru normalnega ali celo nizkega števila trombocitov.
English: • cold sweat
Slovenian: • hladen znoj
English: Following discontinuation of therapy, patients should be monitored for any signs or symptoms of gastrointestinal bleeding.
Slovenian: Po prekinitvi zdravljenja je treba bolnike opazovati glede morebitnih znakov ali simptomov gastrointestinalne krvavitve.
English: In clinical studies with eltrombopag, a dose reduction of statins by 50% was recommended.
Slovenian: V kliničnih študijah z eltrombopagom je bilo priporočeno, da se odmerek statinov zmanjša za 50 %.
English: • Use a reliable method of contraception while you're taking Revolade, to prevent pregnancy
Slovenian: • Med zdravljenjem z zdravilom Revolade morate uporabljati zanesljivo metodo kontracepcije in tako preprečiti zanositev.
English: Eltrombopag should only be administered to such patients after careful consideration of the expected benefits in comparison with the risks.
Slovenian: Ti bolniki lahko prejemajo eltrombopag le po skrbnem premisleku o pričakovanih koristih v primerjavi s tveganji.
English: A decision must be made whether to discontinue breast-feeding or to continue/abstain from Revolade therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Pri odločanju o prekinitvi dojenja ali nadaljevanju / prenehanju z zdravljenjem z zdravilom Revolade je treba upoštevati tako korist dojenja za otroka kot korist zdravljenja za mater.
English: No specific temporal relationship between start of treatment and event of TEE were observed.
Slovenian: Niso opazili posebne vzročne povezave med začetkom zdravljenja in pojavom trombemboličnih dogodkov.
English: The efficacy and safety of eltrombopag for the treatment of thrombocytopenia in patients with HCV infection were evaluated in two randomised, double-blind, placebo-controlled studies.
Slovenian: Učinkovitost in varnost eltrombopaga za zdravljenje trombocitopenije pri bolnikih z okužbo HCV so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: To prepare and give a dose of Revolade, you need:
Slovenian: Za pripravo in odmerjanje zdravila Revolade potrebujete:
English: If you do not have routine eye-tests, your doctor should arrange regular testing.
Slovenian: Če nimate rednih očesnih pregledov, vam jih bo vaš zdravnik uredil.
English: 1 to 5 years (n=38)
Slovenian: 1 do 5 let (n = 38)
English: If you stop taking Revolade
Slovenian: Če ste prenehali jemati zdravilo Revolade
English: • increase of liver enzymes (aspartate aminotransferase (AST))
Slovenian: • zvišane vrednosti jetrnih encimov (aspartat aminotransferaze (AST))
English: Paediatric Population (aged 1 to 17 years)
Slovenian: Pediatrična populacija (v starosti od 1 leta do 17 let)
English: If you have either of these signs of liver problems:
Slovenian: Če se pojavi katerikoli od naslednjih znakov okvare jeter:
English: Across the programme, no patients had evidence of clinically relevant bone marrow abnormalities or clinical findings that would indicate bone marrow dysfunction.
Slovenian: Med programom kliničnih študij pri nobenem bolniku niso bili ugotovljeni znaki klinično pomembnih nepravilnosti kostnega mozga ali klinični znaki, ki bi kazali na nepravilno delovanje kostnega mozga.
English: Effects of eltrombopag on other medicinal products
Slovenian: Vpliv eltrombopaga na druga zdravila
English: Carton of 25 mg powder for oral suspension - without blue box - 30 sachets
Slovenian: Škatla za 25 mg prašek za peroralno suspenzijo - brez modrega okenca - 30 vrečic
English: Unchanged parent compound (eltrombopag) is not detected in urine.
Slovenian: Nespremenjene izvorne učinkovine (eltrombopaga) v urinu niso odkrili.
English: Eighty-six percent of patients were RBC transfusion dependent, and 91% were platelet transfusion dependent.
Slovenian: Šestinosemdeset odstotkov bolnikov je bilo odvisnih od transfuzij eritrocitov, 91 % pa jih je bilo odvisnih od transfuzij trombocitov.
English: More than half of all patients in each treatment group had ≥3 prior ITP therapies and 36% had a prior splenectomy.
Slovenian: Več kot polovica vseh bolnikov v vsaki od skupin zdravljenja je imela ≥3 predhodne terapije ITP, splenektomija pa je bila predhodno opravljena pri 36 % bolnikov.
English: The aim of treatment with eltrombopag should be to achieve the minimum level of platelet counts needed to initiate antiviral therapy, in adherence to clinical practice recommendations.
Slovenian: Cilj zdravljenja z eltrombopagom je doseči najmanjši nivo števila trombocitov, ki je potreben za uvedbo protivirusnega zdravljenja, v skladu s priporočili klinične prakse.
English: In the clinical studies there was one report of overdose where the patient ingested 5000 mg of eltrombopag.
Slovenian: V kliničnih študijah so poročali o enem primeru prevelikega odmerjanja pri bolniku, ki je zaužil 5.000 mg eltrombopaga.
English: • feeling cold
Slovenian: • občutek mraza
English: Revolade is not recommended for children aged under 1 year who have ITP.
Slovenian: Zdravilo Revolade ni priporočljivo za otroke, ki so stari manj kot 1 leto in imajo ITP.
English: • sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or rapid breathing, which could be signs of a blood clot in the lungs (see ‘Higher risk of blood clots' earlier in section 4)
Slovenian: • nenaden pojav zadihanosti, zlasti če ga spremlja ostra bolečina v prsnem košu in/ali hitro dihanje, ki je lahko znak krvnega strdka v pljučih (glejte začetni del poglavja 4 "Večja nevarnost krvnih strdkov")
English: Platelets are blood cells that help to reduce or prevent bleeding.
Slovenian: Trombociti so krvne celice, ki sodelujejo pri zaustavljanju krvavitev oziroma preprečujejo krvavitve.
English: Nine of these patients achieved a multi-lineage response, 4 of the 9 remain on treatment and 5 tapered off treatment with eltrombopag and maintained the response (median follow up: 20.6 months, range: 5.7 to 22.5 months).
Slovenian: Pri devetih izmed teh bolnikov je prišlo do odziva pri več linijah krvnih celic; štirje od devetih so nadaljevali z zdravljenjem, pet pa jih je s postopnim zmanjševanjem odmerka z zdravljenjem prenehalo, pri čemer se je odziv ohranil (mediana spremljanja: 20,6 meseca, v razponu od 5,7 do 22,5 meseca).
English: Eltrombopag is a substrate for BCRP, but is not a substrate for P-glycoprotein or OATP1B1.
Slovenian: Eltrombopag je substrat za BCRP, ni pa substrat za P-glikoprotein ali OATP1B1.
English: Heart monitoring
Slovenian: Spremljanje srčne funkcije
English: Eltrombopag treatment delayed and reduced the number of peginterferon dose reductions.
Slovenian: Zdravljenje z eltrombopagom je zakasnilo in znižalo število zmanjšanj odmerkov peginterferona.
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Slovenian: Glaxo Wellcome S.A., Avenida de Extremadura, 3, 09400 Aranda de Duero, Burgos, Španija Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Velika Britanija
English: Get medical help immediately if you have any of these signs of a blood clot:
Slovenian: Takoj poiščite zdravniško pomoč, če se pojavi katerikoli od naslednjih znakov krvnih strdkov:
English: Thirty-one percent of patients had been treated with prior HCV therapies, primarily pegylated interferon plus ribavirin.
Slovenian: 31 % bolnikov je bilo že predhodno zdravljenih za HCV, primarno s pegiliranim interferonom in ribavirinom.
English: The laminate material is comprised of polyester (PET) / orientated polyamide (OPA) / 9 µm aluminium foil (AL) / low density polyethylene heat seal layer (LDPE).
Slovenian: Laminatni material sestavljajo poliester (PET) / orientiran poliamid (OPA) / aluminijasta folija debeline 9 µm (AL) / toplotno zavarjena plast iz polietilena nizke gostote (LDPE).
English: p-value a
Slovenian: vrednost p a
English: In non-splenectomised patients this should include evaluation relative to splenectomy.
Slovenian: Pri bolnikih, pri katerih ni bila opravljena splenektomija, je treba izvesti tudi ovrednotenje glede na splenektomijo.
English: • Make sure not to spill the powder outside the mixing bottle.
Slovenian: • Pazite, da praška ne boste stresli mimo plastenke.
English: You will be monitored for any signs or symptoms of side effects and given appropriate treatment immediately.
Slovenian: Nadzirali vas bodo za morebiten pojav kateregakoli znaka ali simptoma neželenih učinkov in po potrebi nemudoma uvedli ustrezno zdravljenje.
English: Stop eltrombopag; for at least one week.
Slovenian: Zdravljenje z eltrombopagom prekinite za najmanj en teden.
English: • problems with balance, speech and nerve function, shaking
Slovenian: • težave z ravnotežjem, težave z govorom in delovanjem živcev, tresenje
English: If counts remain stable after 8 weeks at the reduced dose, then eltrombopag must be discontinued and blood counts monitored.
Slovenian: Če število celic ostane stabilno po 8 tednih uporabe zmanjšanega odmerka, je treba zdravljenje z eltrombopagom prekiniti in spremljati krvno sliko.
English: • medicines called statins, to lower cholesterol
Slovenian: • zdravila, imenovana statini, ki jih uporabljamo za zniževanje vrednosti holesterola.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Slovenian: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Velika Britanija
English: Eltrombopag is metabolised through multiple pathways including CYP1A2, CYP2C8, UGT1A1, and UGT1A3 (see section 5.2).
Slovenian: Presnova eltrombopaga poteka po več poteh, vključno z encimi CYP1A2, CYP2C8, UGT1A1 in UGT1A3 (glejte poglavje 5.2).
English: How to take the tablets Swallow the tablet whole, with some water.
Slovenian: Kako je treba jemati tablete Tableto pogoltnite celo skupaj z vodo.
English: • Revolade may also be used to treat adult patients with low blood counts caused by severe aplastic anaemia (SAA).
Slovenian: • Zdravilo Revolade se lahko uporablja tudi pri zdravljenju odraslih bolnikov z zmanjšanim številom krvnih celic, ki ga povzroča huda aplastična anemija.
English: You may also be checked for the occurrence of any bleeding in or around your retina (the light-sensitive layer of cells at the back of the eye).
Slovenian: Lahko vas bodo pregledali tudi zaradi možnega pojava kakršnihkoli krvavitev v mrežnici in okrog mrežnice (za svetlobo občutljiva plast celic v notranjosti očesa).
English: Revolade should not be used outside of clinical studies for the treatment of thrombocytopenia due to MDS.
Slovenian: Zdravila Revolade se izven kliničnih študij ne sme uporabljati za zdravljenje trombocitopenije, ki je posledica MDS.
English: Following reconstitution, the medicinal product should be administered immediately but may be stored for a maximum period of 30 minutes.
Slovenian: Po rekonstituciji je zdravilo treba uporabiti takoj, hraniti ga je mogoče največ 30 minut.
English: For more information, see ‘When to take it' in section 3.
Slovenian: Za več informacij glejte poglavje 3 »Kdaj vzeti zdravilo Revolade«.
English: OATP1B1 and BCRP substrates
Slovenian: Substrati za OATP1B1 in BCRP
English: Glaxo Wellcome S.A. Avenida de Extremadura 3 09400 Aranda de Duero Burgos
Slovenian: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Španija
English: Dispose of the unused mixture in your household waste; don't pour it down the drain.
Slovenian: Neporabljeno mešanico zavrzite med gospodinjske odpadke, ne zlivajte pa je v odtok.
English: Because eltrombopag is not significantly renally excreted and is highly bound to plasma proteins, haemodialysis would not be expected to be an effective method to enhance the elimination of eltrombopag.
Slovenian: Ker se eltrombopag ne izloča v pomembnem obsegu preko ledvic, njegova vezava na plazemske proteine pa je obsežna, hemodializa verjetno ni učinkovita metoda za pospešitev izločanja eltrombopaga iz telesa.
English: While you are taking Revolade, you will be under the care of a doctor with specialist experience in treating your condition.
Slovenian: V času, ko boste jemali zdravilo Revolade, bo za vas skrbel zdravnik specialist, ki ima izkušnje z zdravljenjem bolezni, kot je vaša.
English: Safety pharmacology and repeat-dose toxicity
Slovenian: Farmakološka varnost in toksičnost pri ponavljajočih odmerkih
English: During antiviral therapy, the aim of treatment should be to keep platelet counts at a level that prevents the risk of bleeding complications, normally around 50,000-75,000/µl.
Slovenian: Med protivirusnim zdravljenjem je cilj zdravljenja vzdrževanje števila trombocitov na nivoju, ki preprečuje nevarnost zapletov s krvavitvami, običajno okoli 50.000-75.000/µl.
English: In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation.
Slovenian: V kliničnih študijah, se je število trombocitov povečalo v 1 do 2 tednih po uvedbi eltrombopaga in zmanjšalo v 1 do 2 tednih po prekinitivi.
English: Revolade is not recommended during pregnancy.
Slovenian: Uporaba zdravila Revolade ni priporočljiva med nosečnostjo.
English: HCV protease inhibitors
Slovenian: Zaviralci HCV proteaze
English: If the abnormalities are confirmed, serum liver tests should be monitored until the abnormalities resolve, stabilise, or return to baseline levels.
Slovenian: Če se nepravilnosti potrdijo, je treba rezultate testov jetrne funkcije nadzirati dokler se vrednosti ne normalizirajo, stabilizirajo ali povrnejo na izhodiščne vrednosti.
English: Add the powder from the prescribed number of sachets to the bottle.
Slovenian: Prašek iz predpisanega števila vrečic stresite v plastenko.
English: • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Slovenian: • jih spremljajo klinični simptomi okvare jeter ali znaki jetrne dekompenzacije.
English: 30 sachets of powder
Slovenian: 30 vrečic s praškom
English: Most patients receiving eltrombopag in combination with peginterferon / ribavirin therapy will experience indirect hyperbilirubinaemia.
Slovenian: Pri večini bolnikov, ki prejemajo eltrombopag sočasno s peginterferonom/ribavirinom, bo prišlo do indirektne hiperbilirubinemije.
English: ENABLE 2
Slovenian: ENABLE 2b
English: Eltrombopag administration can cause abnormal liver function and severe hepatotoxicity, which might be life-threatening (see section 4.8).
Slovenian: Zdravljenje z eltrombopagom lahko povzroči nenormalno delovanje jeter in hudo hepatotoksičnost, ki je lahko življenjsko nevarna (glejte poglavje 4.8).
English: Interference with laboratory tests
Slovenian: Moteno določanje parametrov pri laboratorijskih preiskavah
English: 12 to 17 years (n=62)
Slovenian: 12 do 17 let (n = 62)
English: HCV study population (in combination with anti-viral interferon and ribavirin therapy)
Slovenian: HCV študijska populacija (v kombinaciji s protivirusnim interferonskim zdravljenjem in zdravljenjem z ribavirinom)
English: • Slowly push the plunger all the way down so the medicine goes into the child's mouth.
Slovenian: • Počasi potiskajte bat do konca, tako da bo šla celotna količina zdravila v otrokova usta.
English: • Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment.
Slovenian: • Zdravilo Revolade se lahko uporablja tudi za zdravljenje nizkega števila trombocitov (trombocitopenija) pri odraslih s hepatitisom C (okužba s hepatitis C virusom (HCV)), če so imeli v času zdravljenja z interferoni težave z neželenimi učinki.
English: Monitoring and dose adjustment
Slovenian: Nadziranje in prilagajanje odmerka
English: Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin.
Slovenian: Medsebojno delovanje pričakujemo tudi z drugimi zaviralci reduktaze HMG-CoA, vključno z atorvastatinom, fluvastatinom, lovastatinom, pravastatinom in simvastatinom.
English: If you are taking interferon-based treatments together with Revolade to treat low platelet count due to hepatitis C, some liver problems can get worse.
Slovenian: Če prejemate zdravljenje z interferonom skupaj z zdravilom Revolade za zdravljenje nizkega števila trombocitov zaradi okužbe s hepatitis C virusom, se lahko nekatere težave z jetri poslabšajo.
English: Placebo n/N (%) [95% CI]
Slovenian: placebo n/N (%) [95 % IZ]
English: Eye examinations
Slovenian: Preiskave oči
English: Food low in calcium (<50 mg calcium), including fruit, lean ham, beef and unfortified (no added calcium, magnesium or iron) fruit juice, unfortified soya milk and unfortified grain, did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content (see sections 4.2 and 4.5).
Slovenian: Hrana z majhno vsebnostjo kalcija (< 50 mg kalcija), vključno s sadjem, pusto šunko, govedino, sadnimi sokovi brez dodatkov (brez dodanega kalcija, magnezija ali železa), sojinim mlekom brez dodatkov in žitaricami brez dodatkov, ni pomembno vplivala na izpostavljenost eltrombopagu v plazmi ne glede na kalorično vrednost in vsebnost maščob (glejte poglavji 4.2 in 4.5).
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see section 4.4).
Slovenian: Bolnike s temi lastnostmi je potrebno skrbno spremljati glede znakov in simptomov jetrne dekompenazcije (glejte poglavje 4.4).
English: In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (<3-fold increase in mutation frequency).
Slovenian: Pri in vitro testu na mišjem limfomu je bil eltrombopag mejno pozitiven (<3-kratno povečanje pogostnosti mutacij).
English: In conclusion, taking into account the exposure margins based on AUC, a risk of eltrombopag-related cataracts in paediatric patients cannot be excluded.
Slovenian: Ob upoštevanju mejnih vrednosti izpostavljenosti na osnovi AUC pri pediatričnih bolnikih torej ni mogoče izključiti tveganja za razvoj katarakte zaradi eltrombopaga.
English: Effects of other medicinal products on eltrombopag
Slovenian: Vpliv drugih zdravil na eltrombopag
English: No case of TEE was identified from a clinical study in refractory SAA, however the risk of these events cannot be excluded in this patient population due to the limited number of exposed patients.
Slovenian: V klinični študiji z bolniki z neodzivno hudo aplastično anemijo ni bilo nobenega primera trombemboličnega dogodka, vendar pri tej skupini bolnikov ni mogoče izključiti tveganja za tovrstne dogodke, saj je bilo število izpostavljenih bolnikov majhno.
English: • increased levels of some proteins
Slovenian: • zvišane vrednosti nekaterih beljakovin
English: Higher risk of blood clots
Slovenian: Večja nevarnost krvnih strdkov
English: TPO-R agonists are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation and platelet production.
Slovenian: Agonisti TPO-R so rastni faktorji, ki povzročijo ekspanzijo trombocitopoetičnih matičnih celic, diferenciacijo in tvorbo trombocitov.
English: The pharmacokinetic parameters of eltrombopag in paediatric patients with ITP are shown in Table 10.
Slovenian: Farmakokinetični parametri eltrombopaga pri pediatričnih bolnikih z ITP so prikazani v preglednici 10.
English: In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates.
Slovenian: V študijah s humanimi jetrnimi mikrosomi eltrombopag (do 100 M) in vitro ni zaviral encimov citokroma CYP450 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5 in 4A9/11, zaviral pa je encima CYP2C8 in CYP2C9, kar je bilo dokazano z uporabo paklitaksela in diklofenaka kot preizkusnih substratov.
English: Ocular changes
Slovenian: Okularne spremembe
English: Minor metabolites due to glucuronidation and oxidation were also detected.
Slovenian: Odkrili so tudi manj pomembne presnovke zaradi glukuronidacije in oksidacije.
English: Do not open the foil sachets until ready for use.
Slovenian: Folijske vrečice odprite tik pred uporabo.
English: Eltrombopag is primarily metabolised through cleavage, oxidation and conjugation with glucuronic acid, glutathione, or cysteine.
Slovenian: Presnova eltrombopaga v glavnem poteka preko razcepitve, oksidacije in konjugacije z glukuronsko kislino, glutationom ali cisteinom.
English: It is not known whether eltrombopag/metabolites are excreted in human milk.
Slovenian: Ni znano, če se eltrombopag / njegovi presnovki izločajo z mlekom pri človeku.
English: Patients achieving target platelet counts and initiating antiviral therapy c
Slovenian: Bolniki, ki so dosegli ciljno število trombocitov in začeli s protivirusnim zdravljenjem c
English: HMG CoA reductase inhibitors
Slovenian: Zaviralci reduktaze HMG CoA
English: Eltrombopag inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinaemia.
Slovenian: Eltrombopag zavira UGT1A1 in OATP1B1, ki lahko vodi v indirektno hiperbilirubinemijo.
English: Revolade contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Slovenian: Zdravilo Revolade vsebuje eltrombopag, ki sodi v skupino zdravil, ki jih imenujemo agonisti trombopoetinskih receptorjev.
English: Key secondary endpoints
Slovenian: Ključni sekundarni opazovani dogodki
English: Heat-sealed foil laminate sachets.
Slovenian: Toplotno zavarjene vrečice iz laminatne folije.
English: The other ingredients are: mannitol, sucralose and xanthan gum.
Slovenian: Druge sestavine zdravila so: manitol, sukraloza in ksantanski gumi.
English: Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the study and 53% (8/15) of patients were able to reduce (n=1) or discontinue (n=7) baseline ITP therapy, mainly corticosteroids, without needing rescue therapy.
Slovenian: V študiji sta bila znižanje ali prekinitev izhodiščnega odmerjanja zdravil za ITP bolnikom dovoljena samo v fazi odprtega zdravljenja in 53 % (8/15) bolnikov je uspelo znižati (n = 1) oziroma prekiniti (n = 7) izhodiščno zdravljenje ITP, večinoma zdravljenje s kortikosteroidi, ne da bi potrebovali rešilno zdravljenje.
English: 30 sachets.
Slovenian: 30 vrečic.
English: Paediatric population (aged 1 to 17 years) The safety and efficacy of eltrombopag in paediatric patients have been investigated in two studies.
Slovenian: Pediatrična populacija (v starosti od 1 leta do 17 let) Varnost in učinkovitost eltrombopaga pri pediatričnih bolnikih so raziskovali v dveh študijah.
English: Make sure the cap is firmly pushed onto the lid, so it is closed.
Slovenian: Pazite, da boste poklopec trdno pritisnili na zaporko, tako da bo dobro zaprta.
English: In case of an overdose, consideration should be given to oral administration of a metal cation-containing preparation, such as calcium, aluminium, or magnesium preparations to chelate eltrombopag and thus limit absorption.
Slovenian: V primeru prevelikega odmerjanja je treba razmisliti o peroralni aplikaciji pripravkov s kovinskimi kationi, kot so kalcijevi, aluminijevi ali magnezijevi pripravki, ki tvorijo kelate z eltrombopagom in tako omejijo absorpcijo.
English: PETIT2 (TRA115450) was a 2-part, double-blind and open-label, randomised, placebo-controlled study.
Slovenian: Študija PETIT2 (TRA115450) je bila dvodelna, dvojno slepa in nezaslepljena, randomizirana, s placebom kontrolirana študija.