FrancophonIA/ELRC3.0 huggingface dataset:
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo) (see section 4.4).
Slovenian: Najbolj pogost trombembolični dogodek v obeh zdravljenih skupinah (2 % pri bolnikih, ki so prejemali eltrombopag in <1 % pri bolnikih, ki so prejemali placebo) je bila tromboza portalne vene (glejte poglavje 4.4).
English: Common Hypokalaemia, decreased appetite, blood uric acid increased Uncommon Anorexia, gout, hypocalcaemia
Slovenian: Presnovne in prehranske motnje pogosti hipokaliemija, zmanjšanje apetita, zvišana vrednost sečne kisline v krvi občasni anoreksija, protin, hipokalciemija
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is one 50 mg tablet of Revolade a day.
Slovenian: Odrasli in otroci (stari od 6 do 17 let) - običajni začetni odmerek za bolnike z ITP je ena 50 mg tableta zdravila Revolade na dan.
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg*.
Slovenian: Ko se število trombocitov zmanjša na ≤100.000/µl, ponovno uvedite zdravljenje v dnevnem odmerku, zmanjšanem za 25 mg*.
English: constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles
Slovenian: napihnjen trebuh, motnje okušanja, vnetje v trebuhu, hemoroidi, vnetje črevesja
English: In controlled studies in thrombocytopenic patients with HCV (n=1439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs.
Slovenian: V kontroliranih študijah pri trombocitopeničnih bolnikih s HCV (n = 1439), so se trombembolični dogodki pojavili pri 38 od 955 (4 %) bolnikih, ki so prejemali eltrombopag in pri 6 od 484 (1 %) bolnikih, ki so prejemali placebo.
English: • increased haemaglobin level
Slovenian: • zvišano število mielocitov
English: Haematologic malignancies
Slovenian: Hematološki malignomi
English: A total of 14 patients entered the extension phase of the trial.
Slovenian: V obdobju podaljšanja študije je nadaljevalo z zdravljenjem 14 bolnikov.
English: Common Blood creatine phosphokinase increased
Slovenian: Preiskave pogosti zvišana vrednost kreatin kinaze v krvi
English: What Revolade looks like and contents of the pack Revolade 12.5 mg film-coated tablets are round, biconvex, white, debossed with ‘GS MZ1' and ‘12.5' on one side.
Slovenian: Revolade 12,5 mg filmsko obložene tablete so okrogle, obojestransko izbočene, bele filmsko obložene tablete z oznakama ‘GS MZ1' in '12.5' na eni strani.
English: • stomach pain and tenderness
Slovenian: • bolečine in povečana občutljivost trebuha
English: 12.5 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Slovenian: 12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 12,5 mg eltrombopaga v obliki eltrombopagijevega olamina.
English: 30 single-use oral dosing syringes
Slovenian: 30 brizg za peroralno odmerjanje za enkratno uporabo
English: The following side effects have been reported to be associated with treatment with Revolade in adult patients with ITP:
Slovenian: V povezavi z uporabo zdravila Revolade so pri odraslih bolnikih z ITP poročali o naslednjih neželenih učinkih:
English: There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels ≤35 g/l or model for end stage liver disease (MELD) score ≥10, when treated with eltrombopag in combination with interferon-based therapy.
Slovenian: Pri sočasnem zdravljenju z interferonom in eltrombopagom pri trombocitopeničnih bolnikih s HCV in z napredovalo kronično boleznijo jeter, ki je definirana z nizko vrednostjo albuminov ≤35 g/l ali oceno po prognostičnem modelu napredovale jetrne bolezni (MELD - model for end stage liver disease) ≥10, obstaja večje tveganje za neželene učinke, vključno z možno jetrno dekompenzacijo s smrtnim izidom in trombemboličnimi dogodki.
English: Common Deep vein thrombosis, haematoma, hot flush Uncommon Embolism, thrombophlebitis superficial, flushing
Slovenian: Žilne bolezni pogosti globoka venska tromboza, haematom, vročinski obliv občasni embolija, površinski tromboflebitis, oblivi z rdečico
English: • feeling sick (nausea)
Slovenian: • občutek vrtenja (vrtoglavica)
English: Don't breast-feed while you are taking Revolade.
Slovenian: Med zdravljenjem z zdravilom Revolade ne smete dojiti.
English: Serum alanine aminotransferase (ALT), aspartate aminotrasferase (AST) and bilirubin should be measured prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose.
Slovenian: Pred uvedbo zdravljenja z eltrombopagom je treba določiti serumske vrednosti alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) in bilirubina.
English: At 4 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human exposure in HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 13 weeks and in rats after 39 weeks of dosing.
Slovenian: Pri izpostavljenosti, ki je na osnovi vrednosti AUC ustrezala ≥4-kratni izpostavljenosti človeka pri klinični uporabi pri bolnikih z ITP pri odmerkih 75 mg/dan in 2-kratni izpostavljenosti človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan, se je katarakta pri miših pojavila po 13 tednih zdravljenja, pri podganah pa po 39 tednih zdravljenja.
English: Revolade 75 mg film-coated tablets EU/1/10/612/007
Slovenian: Revolade 75 mg filmsko obložene tablete EU/1/10/612/007
English: >100,000/µl to ≤150,000/µl
Slovenian: >100.000/µl do 150.000/µl
English: The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment (see section 4.4).
Slovenian: Po prekinitvi zdravljenja se trombocitopenija lahko ponovi (glejte poglavje 4.4).
English: Dose adjustments are based upon the platelet count response.
Slovenian: Prilagoditev odmerka je odvisna glede na odziv števila trombocitov.
English: • interruption of blood supply to part of the heart
Slovenian: • zapora katere od arterij, ki s krvjo oskrbujejo posamezne dele srca
English: White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3' and ‘25' on one side.
Slovenian: Bele, okrogle, obojestransko izbočene filmsko obložene tablete s premerom približno 10,3 mm in oznakama ‘GS NX3' in ‘25' na eni strani.
English: Revolade 12.5 mg film-coated tablets eltrombopag
Slovenian: Revolade 12,5 mg filmsko obložene tablete eltrombopag
English: For TPO-R agonists there is a concern that they may stimulate the progression of existing haematopoietic malignancies such as MDS.
Slovenian: Agonisti trombopoetinskih receptorjev lahko stimulirajo progresijo že prisotne neoplazme hematopoetskega tkiva, kot je mielodisplastični sindrom.
English: Vascular disorders
Slovenian: Število trombocitov
English: Anaemia
Slovenian: Hepatoksičnost
English: Syringe tip
Slovenian: Okvara ledvic
English: • sore throat, runny nose, nasal congestion and sneezing
Slovenian: • vneto grlo oziroma žrelo, izcedek iz nosu, kongestija in kihanje
English: Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS' and ‘75' on one side.
Slovenian: Rožnate, okrogle, obojestransko izbočene filmsko obložene tablete s premerom približno 10,3 mm in oznakama ‘GS FFS' in '75' na eni strani.
English: If you are of Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) you may need to start at a lower dose of 25 mg.
Slovenian: Če ste azijskega porekla (Kitajci, Japonci, Tajvanci, Tajci ali Korejci), bo vaš začetni odmerek lahko manjši, to je 25 mg.
English: Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see section 4.4).
Slovenian: Pri bolnikih z ITP, ki imajo okvaro jeter (ocena po Child-Pugh-u ≥5), se eltrombopag ne sme uporabljati, razen če pričakovana korist zdravljenja prevlada nad znanim tveganjem za pojav tromboze portalne vene (glejte poglavje 4.4).
English: • Put the tip of the syringe all the way into the water
Slovenian: • Vrh brizge povsem potopite v vodo.
English: If you stop taking Revolade, your blood platelet count is likely to become low again within several days.
Slovenian: Krvne preiskave za določitev števila trombocitov Če prenehate jemati zdravilo Revolade, se lahko število trombocitov v nekaj dneh ponovno zmanjša (trombocitopenija).
English: - If you get any of the side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: RAISE: 197 ITP patients were randomised 2:1, eltrombopag (n=135) to placebo (n=62), and randomisation was stratified based upon splenectomy status, use of ITP medicinal products at baseline and baseline platelet count.
Slovenian: RAISE: 197 bolnikov z ITP je bilo randomiziranih v razmerju 2:1 tako, da je eltrombopag prejemalo 135 bolnikov, placebo pa 62 bolnikov.
English: The effectiveness and safety of Revolade have not been established for the treatment of thrombocytopenia due to MDS.
Slovenian: Pri zdravljenju trombocitopenije, ki je posledica MDS, učinkovitost in varnost zdravila Revolade nista ugotovljeni.
English: When switching between the tablet and powder for oral suspension formulations, platelet counts should be monitored weekly for 2 weeks.
Slovenian: Pri prehodu z uporabe tablet na uporabo praška za peroralno suspenzijo je prva 2 tedna treba bolnikom določati število trombocitov enkrat na teden.
English: • digestive system problems, including being sick (vomiting), stomach pain, indigestion,
Slovenian: • prebavne težave, med drugim bruhanje, bolečine v trebuhu, težave po zaužitju hrane, zaprtje,
English: Common Myalgia, muscle spasm, musculoskeletal pain, bone pain, back pain Uncommon Muscular weakness Renal and urinary disorders Common Proteinuria, blood creatinine increased, thrombotic microangiopathy with renal failure Uncommon Renal failure, leukocyturia, lupus nephritis, nocturia, blood urea increased, urine protein/creatinine ratio increased
Slovenian: Bolezni sečil pogosti proteinurija, zvišana vrednost kreatinina v krvi, trombotična mikroangiopatija z odpovedjo ledvic občasni odpoved ledvic, levkociturija, lupusni nefritis, nikturija, zvišana vrednost sečnine v krvi, zvišano razmerje med proteini in kreatininom v urinu
English: Multipack containing 84 (3 packs of 28) film-coated tablets
Slovenian: Skupno pakiranje, ki vsebuje 84 filmsko obloženih tablet (3 pakiranja po 28 filmsko obloženih tablet)
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo).
Slovenian: Najbolj pogost trombembolični zaplet v obeh zdravljenih skupinah (2 % pri bolnikih, ki so prejemali eltrombopag in <1 % pri bolnikih, ki so prejemali placebo) je bila tromboza portalne vene.
English: In the phase II refractory SAA clinical study with eltrombopag at a dose of 150 mg/day (with ethnic or age related modifications as indicated) (ELT116826), the incidence of new cytogenetic abnormalities was observed in 22.6% of adult patients [7/31 (where 3 of them had changes in chromosome 7)].
Slovenian: V klinični študiji faze II pri bolnikih z neodzivno hudo aplastično anemijo z odmerjanjem eltrombopaga 150 mg/dan (z modifikacijo odmerjanja na osnovi etnične pripadnosti ali starosti v skladu z indikacijami) (študija ELT116826) so pojavljanje novih citogenetskih nepravilnosti opažali pri 22,6 % odraslih bolnikov [7/31 (pri čemer je pri 3 od teh bolnikov prišlo do sprememb na kromosomu 7)].
English: Close monitoring is required when administering to patients with hepatic impairment (see section 4.2).
Slovenian: Bolnike z okvaro jeter je treba skrbno nadzirati (glejte poglavje 4.2).
English: Thrombotic/thromboembolic events (TEEs)
Slovenian: Trombotični/trombembolični dogodki
English: Revolade 75 mg film-coated tablets
Slovenian: Revolade 75 mg filmsko obložene tablete
English: • 1 single-use oral dosing syringe (supplied in the kit)
Slovenian: • 1 brizgo za peroralno odmerjanje za enkratno uporabo (ki je v kompletu)
English: There are limited data on the use of eltrombopag in ITP patients aged 65 years and older and no clinical experience in ITP patients aged over 85 years.
Slovenian: Pri bolnikih z ITP, starih nad 85 let, ni kliničnih izkušenj z uporabo eltrombopaga.
English: If possible show them the pack, or this leaflet.
Slovenian: Zdravniku ali farmacevtu po možnosti pokažite ovojnino zdravila ali to navodilo za uporabo.
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade a day.
Slovenian: Odrasli in otroci (stari od 6 do 17 let) - običajni začetni odmerek za bolnike z ITP je dve 25 mg vrečici zdravila Revolade enkrat na dan.
English: Revolade 25 mg powder for oral suspension
Slovenian: Revolade 25 mg prašek za peroralno suspenzijo
English: People taking Revolade for either ITP or low blood platelet counts due to hepatitis C could develop signs of potentially serious side effects.
Slovenian: Simpotmi, ki potrebujejo pozornost: obiščite zdravnika Pri bolnikih, ki jemljejo zdravilo Revolade zaradi ITP ali nizkega števila trombocitov zaradi hepatitisa C, lahko pride do možnih resnih neželenih učinkov.
English: • unusually dark-coloured urine tell your doctor immediately.
Slovenian: • neobičajno temno obarvan urin,
English: Endosteal hyperostosis was observed in a 28-week toxicity study in rats at a non-tolerated dose of 60 mg/kg/day (6 times or 4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Slovenian: Pri 28-tedenski študiji toksičnosti je bila pri podganah pri odmerku 60 mg/kg/dan, ki ga živali niso prenašale (6-kratna oziroma 4-kratna izpostavljenost človeka pri klinični uporabi pri odraslih oziroma pediatričnih bolnikih z ITP pri odmerkih 75 mg/dan in 3-kratni izpostavljenosti človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan, na osnovi vrednosti AUC), opažena endostalna hiperostoza.
English: The risk-benefit balance should be considered in patients at risk of TEEs of any aetiology.
Slovenian: Pri bolnikih s tveganjem za pojav trombemboličnih dogodkov katerekoli etiologije je treba poskrbeti za ravnovesje med tveganjem in koristjo.
English: 25 mg powder for oral suspension
Slovenian: 25 mg prašek za peroralno suspenzijo
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag and 6 out of 484 patients (1%) in the placebo group experienced thromboembolic events (TEEs).
Slovenian: V kontroliranih študijah pri trombocitopeničnih bolnikih s HCV, ki so bili zdravljeni z interferonom (n = 1439), so se trombembolični dogodki pojavili pri 38 od 955 (4 %) bolnikih, ki so prejemali eltrombopag in pri 6 od 484 (1 %) bolnikih, ki so prejemali placebo.
English: 9/l and absolute reticulocyte count was 24.3 x 10
Slovenian: 9/l, absolutno število retikulocitov pa
English: bronchitis, nasopharyngitis, influenza, oral herpes Uncommon Gastroenteritis, pharyngitis
Slovenian: Infekcijske in parazitske bolezni pogosti okužba sečil, okužba zgornjih dihal, bronhitis, nazofaringitis, gripa, oralni herpes občasni gastroenteritis, faringitis
English: If you are breast-feeding or planning to breast-feed, tell your doctor.
Slovenian: Če dojite ali nameravate dojiti, o tem obvestite zdravnika.
English: Cataracts have not been observed in adult dogs after 52 weeks of dosing at 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Slovenian: Po 52 tednih zdravljenja pri odraslih psih niso poročali o pojavu katarakte pri 2-kratni izpostavljenosti človeka pri klinični uporabi pri odraslih ali pediatričnih bolnikih z ITP pri odmerkih 75 mg/dan in enaki izpostavljenosti človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan, na osnovi vrednosti AUC.
English: • Pull back the plunger until all the medicine is in the syringe.
Slovenian: • Potegnite bat, da boste v brizgo povlekli celotno količino zdravila.
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg tablet of Revolade a day.
Slovenian: Otroci (stari od 1 do 5 let) - običajni začetni odmerek za bolnike z ITP je ena 25 mg tableta zdravila Revolade na dan.
English: Platelet count should be monitored at least weekly for 2 to 3 weeks when eltrombopag is co-administered with ciclosporin.
Slovenian: Pri sočasnem odmerjanju eltrombopaga s ciklosporinom je treba 2 do 3 tedne spremljati število trombocitov najmanj enkrat na teden.
English: Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Slovenian: Eltrombopag pri miših pri odmerkih do 75 mg/kg/dan ali pri podganah pri odmerkih do 40 mg/kg/dan (do 4-kratna oziroma 2-kratna izpostavljenost človeka pri klinični uporabi pri odraslih oziroma pediatričnih bolnikih z ITP pri odmerkih 75 mg/dan in 2-kratna izpostavljenost človeka pri klinični uporabi pri bolnikih s HCV pri odmerkih 100 mg/dan, na osnovi vrednosti AUC) ni deloval kancerogeno.
English: Common Dry eye, vision blurred, eye pain, visual acuity reduced Uncommon Lenticular opacities, astigmatism, cataract cortical, lacrimation increased, retinal haemorrhage, retinal pigment epitheliopathy, visual impairment, visual acuity tests abnormal, blepharitis, keratoconjunctivitis sicca
Slovenian: Očesne bolezni pogosti suhe oči, zamegljen vid, bolečine v očeh, zmanjšana ostrina vida občasni zamotnitve leče, astigmatizem, kortikalna katarakta, močnejše solzenje, krvavitev v mrežnici, pigmentna epiteliopatija mrežnice, okvara vida, nenormalni izvidi preiskav ostrine vida, vnetje veke, suhi keratokonjunktivitis
English: Revolade 50 mg film-coated tablets
Slovenian: Revolade 50 mg filmsko obložene tablete
English: Revolade 75 mg film-coated tablets eltrombopag
Slovenian: Revolade 75 mg filmsko obložene tablete eltrombopag
English: Common Anaemia, eosinophilia, leukocytosis, thrombocytopenia, haemoglobin decreased, white blood cell count decreased Uncommon Anisocytosis, haemolytic anaemia, myelocytosis, band neutrophil count increased, myelocyte present, platelet count increased, haemoglobin increased
Slovenian: Bolezni krvi in limfatičnega sistema pogosti anemija, eozinofilija, levkocitoza, trombocitopenija, znižana vrednost hemoglobina, znižano število levkocitov občasni anizocitoza, hemolitična anemija, mielocitoza, zvišano število nezrelih nevtrofilcev, prisotnost mielocitov, zvišano število trombocitov, zvišana vrednost hemoglobina
English: • nose bleed
Slovenian: • krvaveče dlesni
English: Adults - the usual starting dose for hepatitis C is one 25 mg sachet of Revolade a day.
Slovenian: Odrasli - običajni začetni odmerek za bolnike s hepatitisom C je ena 25 mg vrečica zdravila Revolade na dan.
English: Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU' and ‘50' on one side.
Slovenian: Revolade 50 mg filmsko obložene tablete so okrogle, obojestransko izbočene, rjave filmsko obložene tablete z oznakama ‘GS UFU' in ‘50' na eni strani.
English: 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Slovenian: 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg eltrombopaga v obliki eltrombopagijevega olamina.
English: In the phase II refractory SAA clinical study with eltrombopag with a starting dose of 50 mg/day (escalated every 2 weeks to a maximum of 150 mg/day) (ELT112523), the incidence of new cytogenetic abnormalities was observed in 17.1% of adult patients [7/41 (where 4 of them had changes in chromosome 7)].
Slovenian: V klinični študiji faze II pri bolnikih z neodzivno hudo aplastično anemijo z začetnim odmerjanjem eltrombopaga 50 mg/dan (z zviševanjem odmerka vsaka 2 tedna do največ 150 mg/dan) (študija ELT112523) so pojavljanje novih citogenetskih nepravilnosti opažali pri 17,1 % odraslih bolnikov [7/41 (pri čemer je pri 4 od teh bolnikov prišlo do sprememb na kromosomu 7)].
English: Common Vomiting, ascites, abdominal pain, abdominal pain upper, dyspepsia, dry mouth, constipation, abdominal distension, toothache, stomatitis, gastrooesophagal reflux disease, haemorrhoids, abdominal discomfort, varices oesophageal Uncomon Oesophageal varices haemorrhage, gastritis, aphthous stomatitis
Slovenian: Bolezni prebavil zelo pogosti navzea, driska pogosti bruhanje, ascites, bolečine v trebuhu, bolečina v zgornjem delu trebuha, dispepsija, suha usta, zaprtje, povečan obseg trebuha, zobobol, stomatitis, gastroezofagealna refluksna bolezen, hemoroidi, neprijeten občutek v trebuhu, ezofagealne varice občasni krvavitev ezofagealnih varic, gastritis, aftozni stomatitis
English: Revolade 50 mg film-coated tablets EU/1/10/612/004
Slovenian: Revolade 50 mg filmsko obložene tablete EU/1/10/612/004
English: • Insert the tip of the syringe into the hole in the lid of the mixing bottle.
Slovenian: • Vrh brizge vstavite v odprtino v zaporki mešalne plastenke.
English: Common Pharyngitis, influenza, oral herpes, pneumonia, sinusitis, tonsillitis,
Slovenian: ♦, okužba zgornjih dihal pogosti faringitis, gripa, oralni herpes, pljučnica, sinusitis, tonzillitis, okužba dihal, gingivitis občasni okužba kože
English: • Add 20 ml of water and the contents of the prescribed number of sachets (depending on the recommended dose) to the provided mixing bottle and mix gently.
Slovenian: • V priloženo mešalno plastenko vlijte 20 ml vode in stresite vsebino predpisanega števila vrečic
English: Wash any exposed area immediately with soap and water.
Slovenian: Del telesa, ki pride v stik z zdravilom, takoj umijte z vodo in milom.
English: Platelet counts should be closely monitored and consideration given to reducing the dose or discontinuing eltrombopag treatment if the platelet count exceeds the target levels (see section 4.2).
Slovenian: Če število trombocitov preseže ciljne vrednosti, je treba razmisliti o zmanjšanju odmerka ali prekinitvi zdravljenja z eltrombopagom (glejte poglavje 4.2).
English: • digestive system problems including being sick (vomiting), change in appetite (increased or decreased), stomach pain/discomfort, swollen stomach, passing wind, change in stool colour
Slovenian: • prebavne težave, med drugim bruhanje, spremembe apetita (povečan ali zmanjšan apetit),
English: Uncommon Dry mouth, glossodynia, abdominal tenderness, faeces discoloured, food poisoning, frequent bowel movements, haematemesis, oral discomfort
Slovenian: občasni suha usta, pekoča bolečina v jeziku, občutljivost trebuha, sprememba barve blata, zastrupitev s hrano, pogosto odvajanje blata, hematemeza, neprijeten občutek v ustih
English: How to store Revolade
Slovenian: Shranjevanje zdravila Revolade
English: No dose adjustment is necessary in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati.
English: Your doctor may also carry out tests to directly check your bone marrow during treatment with Revolade.
Slovenian: Med zdravljenjem z zdravilom Revolade lahko zdravnik opravlja preiskave s katerimi bo neposredno preveril delovanje kostnega mozga.
English: Revolade 50 mg film-coated tablets eltrombopag
Slovenian: Revolade 50 mg filmsko obložene tablete eltrombopag
English: It is not known whether eltrombopag increases the risk of cytogenetic abnormalities in patients with SAA.
Slovenian: Znano je, da pri bolnikih s hudo aplastično anemijo prihaja do citogenetskih nepravilnosti, ni pa znano, ali eltrombopag pri bolnikih s hudo aplastično anemijo povečuje tveganje za citogenetske nepravilnosti.
English: Revolade 25 mg film-coated tablets
Slovenian: Revolade 25 mg filmsko obložene tablete