FrancophonIA/ELRC3.0 huggingface dataset:
English: The remaining 5 patients discontinued treatment, three due to relapse at the month 3 extension visit.
Maltese: Il-5 pazjenti li jifdal waqfu mit-trattament, tlieta minħabba rikaduta fit-3 xahar waqt il-viżta ta' estensjoni.
English: This decrease of exposure was attenuated when a single 25 mg dose of eltrombopag powder for oral suspension was administered 2 hours before a high-calcium meal (mean AUC0-∞ was decreased by 20% and mean Cmax by 14%).
Maltese: Dan it-tnaqqis fl-esponiment ġie mnaqqas meta doża waħda ta' 25 mg ta' trab ta' eltrombopag għal suspensjoni orali ngħatat sagħtejn qabel ikla b'ħafna kalċju (l-AUC0-∞ medja tnaqqset b'20% u s-Cmax medja b'14%).
English: At baseline, more than 70% of ITP patients in each treatment group reported any bleeding (WHO Grades 1-4) and more than 20% reported clinically significant bleeding (WHO Grades 2-4), respectively.
Maltese: Fil-linja bażi, aktar minn 70% tal-pazjenti b'ITP f'kull grupp ta' kura rrappurtaw xi fsada (Gradi 1-4 tal-WHO) u aktar minn 20% irrappurtaw fsada sinifikanti b'mod kliniku (Gradi 2-4 tal-WHO), rispettivament.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Maltese: Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 12.5 mg ta' eltrombopag.
English: Five of the 6 patients treated with eltrombopag experienced the thrombotic complication at a platelet count >200,000/µl and within 30 days of the last dose of eltrombopag.
Maltese: Ħamsa mis-6 pazjenti kkurati b'eltrombopag kellhom il-kumplikazzjoni trombotika b'għadd ta' plejtlits ta' >200,000/µl u fi żmien 30 jum mill-aħħar doża ta' eltrombopag.
English: Revolade 50 mg film-coated tablets eltrombopag
Maltese: Revolade 50 mg pilloli miksija b'rita eltrombopag
English: Eltrombopag treatment delayed and reduced the number of peginterferon dose reductions.
Maltese: Effetti ta' eltombopag fuq prodotti mediċinali oħra Impedituri ta' HMG CoA reductase
English: In comparison, at Week 12, 55% of placebo patients reported any bleeding.
Maltese: B'paragun, f'Ġimgħa 12, 55% tal-pazjenti fuq plaċebo irrappurtaw xi fsada.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Maltese: Kull qartas fih eltrombopag olamine ekwivalenti għal 25 mg eltrombopag
English: Once the platelet count is ≤ 100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg. * For patients taking 25 mg eltrombopag once every other day, increase dose to 25 mg once daily.
Maltese: Ladarba l-għadd tal-plejtlits jkun ≤100,000/µl, erġa' ibda t-terapija f'doża ta' kuljum imnaqqsa b'25 mg*.
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon therapy (n=1,439), progression of pre-existing baseline cataract(s) or incident cataracts was reported in 8% of the eltrombopag group and 5% of the placebo group.
Maltese: Katarretti kienu osservati fi studji ta' tossiċità ta' eltrombopag f'annimali gerriema (ara sezzjoni 5.3). Fi studji kkontrollati f'pazjenti tromboċitopeniċi b'HCV li kienu qed jirċievu terapija b'interferon (n=1439), il-progressjoni ta' katarretta(i) pre-eżistenti fil-linja bażi jew katarretti b'inċident kienet irrapportata fi 8% tal-grupp ta' eltrombopag u f'5% tal-grupp tal-plaċebo.
English: On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose adjustments should be avoided (see Table 2).
Maltese: Kif tinbeda t-terapija antivirali l-għadd tal-plejtlits jista' jaqa', għalhekk għandhom jiġu evitati aġġustamenti immedjati għad-doża ta' eltrombopag (ara t-Tabella 2).
English: • increased pH of urine
Maltese: • żieda fil-pH tal-awrina
English: Administration of a single 50 mg dose of eltrombopag in tablet form with a standard high-calorie, high-fat breakfast that included dairy products reduced plasma eltrombopag mean AUC0-∞ by 59% and mean Cmax by 65%.
Maltese: L-għoti ta' doża waħda ta' 50 mg ta' eltrombopag f'forma ta' pillola ma' kolazzjon standard b'ħafna kaloriji u b'ħafna xaħam li kienet tinkludi prodotti tal-ħalib naqqas l-AUC0-∞ medja fil-plażma ta' eltrombopag b'59% u s-Cmax medja b'65%.
English: Liver enzymes measured between Days 2 and 18 after ingestion peaked at a 1.6-fold ULN in AST, a 3.9-fold ULN in ALT, and a 2.4-fold ULN in total bilirubin, The platelet counts were 672,000/µl on Day 18 after ingestion and the maximum platelet count was 929,000/µl.
Maltese: L-enzimi tal-fwied li tkejlu bejn il-Jiem 2 u 18 wara li nbelgħu il-pilloli laħqu l-ogħla punt bl-AST 1.6 drabi aktar mill-ULN, l-ALT 3.9 drabi aktar millULN, u l-bilirubin totali 2.4 drabi aktar mill-ULN.
English: • feeling sick (nausea), diarrhoea
Maltese: • tħossok imdardar/imdardra (nawsja), dijarea
English: The clinical significance of these QTc prolongation events is unknown.
Maltese: Is-sinifikat kliniku ta' dawn l-avvenimenti ta' titwil tal-QTc mhuwiex magħruf.
English: • muscle pain, muscle weakness
Maltese: • uġigħ fil-muskoli, dgħufija fil-muskoli
English: Revolade 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Maltese: Revolade 50 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 50 mg ta' eltrombopag.
English: Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-) values as compared to male patients.
Maltese: Pazjenti pedjatriċi nisa b'ITP kellhom valuri tal-AUC(0-)ta' eltrombopag filplażma madwar 25% ogħla meta mqabbla ma' pazjenti rġiel.
English: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag
Maltese: Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 75 mg eltrombopag
English: Common Rash, alopecia, hyperhidrosis, pruritus generalised, petechiae Uncommon Urticaria, dermatosis, cold sweat, erythema, melanosis,
Maltese: Raxx, alopeċja, iperidrożi, ħakk mifrux, petekje
English: Common Paraesthesia, hypoaesthesia, somnolence, migraine Uncommon Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache
Maltese: Tregħid, disturb fil-bilanċ, disestesija, emiparesi, emigranja blawra, newropatija periferali, newropatija periferali tassensazzjoni, disturb fit-taħdit, newropatija tossika, uġigħ ta' ras vaskulari
English: Revolade 25 mg film-coated tablets eltrombopag
Maltese: Revolade 25 mg pilloli miksija b'rita eltrombopag
English: EU/1/10/612/006 84 film-coated tablets (3 packs of 28)
Maltese: EU/1/10/612/004 (14-il pillola miksija b'rita) EU/1/10/612/005 (28 pillola miksija b'rita) EU/1/10/612/006 84 pillola miksija b'rita (3 pakketti ta' 28)
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)
Maltese: • qtugħ ta' nifs f'daqqa waħda, speċjalment meta jseħħ flimkien ma' uġigħ qawwi fis-sider u/jew teħid tan-nifs mgħaġġel, li jistgħu jkunu sinjali ta' embolu tad-demm fil-pulmun (ara
English: Eltrombopag should be taken at least two hours before or four hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations to avoid significant reduction in eltrombopag absorption due to chelation (see sections 4.2 and 5.2).
Maltese: Eltrombopag għandu jittieħed mill-inqas sagħtejn qabel jew erba' sigħat wara kwalunkwe prodotti bħal antaċidi, prodotti tal-ħalib jew supplimenti ta' minerali li fihom katjoni polivalenti biex jiġi evitat tnaqqis sinifikanti flassorbiment ta' eltrombopag minħabba kelazzjoni (ara sezzjonijiet 4.2 u 5.2).
English: Common Anxiety, depression
Maltese: Disturb fl-irqad, depressjoni
English: Eltrombopag can be administered in addition to other ITP medicinal products.
Maltese: Eltrombopag jista' jingħata flimkien ma' prodotti mediċinali oħra għal ITP.
English: For more information, see ‘When to take it' in section 3.
Maltese: Għal aktar informazzjoni, ara ‘Meta għandek tieħdu' fis-sezzjoni 3.
English: EU/1/10/612/009 84 film-coated tablets (3 packs of 28)
Maltese: EU/1/10/612/007 (14-il pillola miksija b'rita) EU/1/10/612/008 (28 pillola miksija b'rita) EU/1/10/612/009 84 pillola miksija b'rita (3 pakketti ta' 28)
English: 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Maltese: 50 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 50 mg eltrombopag.
English: • medicines such as methotrexate and topotecan, to treat cancer Talk to your doctor if you take any of these.
Maltese: • mediċini bħal methotrexate u topotecan, għall-kura tal-kanċer Kellem lit-tabib tiegħek jekk inti tieħu xi waħda minn dawn.
English: EXPIRY DATE
Maltese: Dejta miġbura
English: Chronic hepatitis C (HCV) associated thrombocytopenia
Maltese: Tromboċitopenja assoċjata ma' epatite Ċ (HCV) kronika
English: For patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Maltese: Għal pazjenti li huma dixxendenti tal-Asja (bħal Ċiniżi, Ġappuniżi, Tajwaniżi, Koreani, jew Tajlandiżi), eltrombopag għandu jinbeda bid-doża mnaqqsa ta' 25 mg darba kuljum (ara sezzjoni 5.2).
English: Revolade 12.5 mg film-coated tablets
Maltese: U KWANTITATTIVA Revolade 12.5 mg pilloli miksija b'rita
English: Routine ophthalmologic monitoring of patients is recommended.
Maltese: Monitoraġġ oftalmoloġiku ta' rutina tal-pazjenti huwa rrakkomandat.
English: The longest platelet transfusion-free period for responders was 287 days (median).
Maltese: L-itwal perjodu liberu minn trasfużjoni ta' plejtlits għal dawk li rrispondew għat-terapija kien ta' 287 jum (medja).
English: Renal effects were not observed in rats after 28 weeks or in dogs after 52 weeks at exposures 4 and 2 times the human clinical exposure in adult ITP patients and 3 and 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Maltese: Effetti fuq il-kliewi ma kinux osservati fil-firien wara 28 ġimgħa jew fil-klieb wara 52 ġimgħa f'esponimenti 4 darbiet u darbtejn ogħla mill-esponiment kliniku uman f'pazjenti adulti b'ITP u 3 darbiet u darbtejn ogħla mill-esponiment kliniku uman f'pazjenti pedjatriċi b'ITP f'75 mg/kuljum u darbtejn u ekwivalenti għall-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC.
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.
Maltese: Eltrombopag għandu jitwaqqaf jekk it-terapija antivirali titwaqqaf għal dikumpensazzjoni epatika.
English: • increased levels of some proteins
Maltese: • żieda fil-livelli ta' xi proteini
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see section 4.4).
Maltese: Id-dehra mill-ġdid ta' tromboċitopenija hija possibbli mal-waqfien tal-kura (ara sezzjoni 4.4).
English: Effects of eltrombopag on other medicinal products
Maltese: Effetti ta' eltombopag fuq prodotti mediċinali oħra
English: • decreased appetite
Maltese: • nuqqas ta' aptit
English: Revolade 75 mg film-coated tablets Tablet core
Maltese: Revolade 75 mg pilloli miksija b'rita Qalba tal-pillola
English: Revolade 25 mg film-coated tablets are round, biconvex, white, debossed with ‘GS NX3' and ‘25' on one side.
Maltese: Il-pilloli miksijin b'rita Revolade 25 mg huma tondi, konvessi fuq iż-żewġ naħat, bojod, u mnaqqxin b'‘GS NX3' u ‘25' fuq naħa waħda.
English: CARTON OF 75 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' 75 mg - 14, 28, 84 (3 PAKKETTI ta' 28) PILLOLA
English: However, cataracts were not observed in juvenile rats given tolerated doses at 5 times the human clinical exposure in paediatric ITP patients, based on AUC.
Maltese: Madankollu, ma kienux osservati katarretti f'firien frieħ li ngħataw dożi ttollerati 5 darbiet lesponiment kliniku fil-bniedem f'pazjenti pedjatriċi b'ITP, ibbażat fuq l-AUC.
English: Based on estimates from the population pharmacokinetic analysis, Asian ITP patients had approximately 49% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients who were predominantly Caucasian (see section 4.2).
Maltese: Fuq bażi ta' stimi millanaliżi ta' farmakokinetika tal-popolazzjoni, pazjenti Asjatiċib'ITP kellhom valuri ta' AUC(0-) ta' eltrombopag fil-pażma madwar 49% ogħla meta mqabbla ma' pazjenti mhux mill-Asja li kienu lbiċċa l-kbira Kawkasi (ara sezzjoni 4.2).
English: The pharmacokinetics of eltrombopag have been studied after administration of eltrombopag to adult patients with renal impairment.
Maltese: II, fuq grupp wieħed fost pazjenti b'SAA li kienu reżistenti għat-terapija, urew riżultati konsistenti.
English: Patients with bleeding (WHO Grades 1-4) at any time during 6 months, n (%)
Maltese: Pazjenti bi fsada (Gradi 1-4 tal-WHO) fi kwalunkwe żmien waqt is-6 xhur, n (%)
English: • anxiety
Maltese: • ansjetà
English: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag
Maltese: Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 50 mg eltrombopag
English: Pooled data
Maltese: U KWANTITATTIVA
English: 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Maltese: 25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 25 mg eltrombopag.
English: Based on model estimate, female HCV patient had approximately 41% higher plasma eltrombopag AUC(0-) as compared to male patients.
Maltese: Fuq il-bażi ta' stimi minn mudell, il-pazjenti nisa b'HCV kellhom AUC(0-) ta' eltrombopag fil-plasma madwar 41% ogħla meta mqabbla ma' pazjenti rġiel.
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.
Maltese: B'esponimenti 4 darbiet minn dak kliniku uman f'pazjenti b'ITP f'75 mg/kuljum u darbtejn ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC, il-kataretti kienu osservati fil-ġrieden wara 13-il ġimgħa u filfirien wara 39 ġimgħa ta' għoti ta' dożi.
English: Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day.
Maltese: Adulti - is-soltu d-doża tal-bidu għall-epatite Ċ hija pillola waħda ta' 25 mg ta' Revolade kuljum.
English: TPO-R agonists are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation and platelet production.
Maltese: Agonisti TPO-R huma fatturi ta' tkabbir li jwasslu għall-espansjoni taċ-ċellula proġenitura trombopoetika, divrenzjar, u għall-produzzjoni ta' plejtlits.
English: If your doctor considers that the benefits of taking Revolade outweigh the risks, you will be closely monitored during treatment.
Maltese: Jekk it-tabib tiegħek jikkunsidra li l-benefiċċji li tieħu Revolade huma akbar mir-riskji, inti se tiġi mmonitorjat mill-qrib waqt ittrattament.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: Neoplażmi beninni. malinni u dawk mhux speċifikati (inkluż ċesti u polipi)
English: The longest RBC transfusion-free period for responders was 266 days (median).
Maltese: L-itwal perjodu liberu minn trasfużjoni ta' RBC għal dawk li rrispondew għat-terapija kien ta' 266 jum (medja).
English: • Throw away the used oral dosing syringe.
Maltese: • Armi s-siringa tad-dożaġġ orali użata.
English: Older people (65 years and above)
Maltese: Anzjani (65 sena u aktar)
English: Revolade 25 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Maltese: Revolade 25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 25 mg ta' eltrombopag.
English: Adults - the usual starting dose for SAA is two 25 mg sachets of Revolade a day.
Maltese: Adulti - is-soltu d-doża tal-bidu għal SAA hija żewġ qratas ta' 25 mg ta' Revolade kuljum.
English: Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Maltese: Revolade hu indikat għal pazjenti adulti li għandhom anemija aplastika gravi (SAA) li ntirtet li jew kienu reżistenti għal terapija immunosuppressiva mogħtija qabel jew inkella ingħataw trattament qawwi minn qabel u mhumiex tajbin għal trapjant ematopoetiku taċ-ċellula staminali (ara sezzjoni 5.1).
English: Platelet count
Maltese: Tibdil okulari
English: They are supplied in aluminum blisters in a carton containing 14 or 28 film-coated tablets and multipacks containg 84 (3 packs of 28) film-coated tablets).
Maltese: Huma jiġu fornuti f'folji tal-aluminju f'kartuna li fiha 14 jew 28 pillola miksijin b'rita u pakketti b'ħafna li fihom 84 (3 pakketti ta' 28) pillola miksijin b'rita.
English: Six patients had cytogenetic abnormality at Month 3 of eltrombopag therapy and one patient had cytogenetic abnormality at Month 6.
Maltese: Sitt pazjenti kellhom anormalità ċitoġenetika fit-3 Xahar ta' terapija b'eltrombopag u pazjent wieħed kellu anormalità ċitoġenetika fis-6 Xahar.
English: Over 50% of responders who were transfusion-dependent at baseline, had >80% reduction in both platelet and RBC transfusion requirements compared to baseline.
Maltese: Aktar minn 50% ta' dawk li rrispondew li kienu jiddependu minn trasfużjoni fil-linja bażi, kellhom >80% tnaqqis fil-bżonn ta' trasfużjoni ta' plejtlits u ta' trasfużjoni ta' RBC imqabbel mal-linja bażi.
English: • inflammation (swelling) and infection of the tonsils infection of the lungs, sinuses, tonsils, nose and throat
Maltese: • infjammazzjoni (nefħa) u infezzjoni tal-infezzjoni tat-tunsilli tal-pulmuni, is-sinuses, it tunsilli, l-imnieħer u l-griżmejn
English: • difficulty in sleeping (insomnia)
Maltese: • diffikultà biex torqod (insomnja)
English: Each sachet contains a powder for reconstitution that delivers 32 mg eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.
Maltese: Kull qartas fih trab għar-rikostituzzjoni li jagħti 32 mg eltrombopag olamine, ekwivalenti għal 25 mg ta' aċidu ħieles ta' eltrombopag.
English: EU/1/10/612/003 84 film-coated tablets (3 packs of 28)
Maltese: EU/1/10/612/001 (14-il pillola miksija b'rita) EU/1/10/612/002 (28 pillola miksija b'rita) EU/1/10/612/003 84 pillola miksija b'rita (3 pakketti ta' 28)
English: Grouped term with preferred terms acute kidney injury and renal failure
Maltese: Terminu miġbur flimkien ma' termini ppreferuti oligurja, insuffiċjenza tal-kliewi u indeboliment tal-kliewi
English: Common Chromaturia
Maltese: Kromaturja
English: Revolade 25 mg film-coated tablets
Maltese: Revolade 25 mg pilloli miksija b'rita
English: • ear pain
Maltese: • embolu tad-demm
English: Cap
Maltese: Komuni
English: p-valuea a Logistic regression model adjusted for randomisation stratification variables
Maltese: Valur-p a a Mudell ta' rigressjoni loġistika aġġustat għal varjabbli ta' stratifikazzjoni u randomisation
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.
Maltese: L-istimi tas-Cmax u tal-AUC(0-) ta' eltrombopag fil-plasma għal pazjenti b'HCV li ħadu sehem fl-istudji tal-fażi
English: CARTON OF 50 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' 50 mg - 14, 28, 84 (3 PAKKETTI ta' 28) PILLOLA
English: CARTON OF 25 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' 25 mg - 14, 28, 84 (3 PAKKETTI ta' 28) PILLOLA
English: There is a theoretical concern that TPO-R agonists may stimulate the progression of existing haematological malignancies such as MDS.
Maltese: Hemm tħassib teoretiku li l-agonisti ta' TPO-R jistgħu jistimulaw il-progressjoni ta' tumuri malinni ematoloġiċi eżistenti bħal MDS.
English: g.h/ml a, g/ml Cmax
Maltese: N AUC(0-) a, g.siegħa/ml
English: Increased bone marrow reticulin
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONI RIGWARD ILPROVVISTA
English: Clean the mixing equipment.
Maltese: Mhux applikabbli.
English: Get medical help immediately if you develop signs and symptoms of a blood clot, such as:
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' TEE.
English: Eltrombopag is a substrate for BCRP, but is not a substrate for P-glycoprotein or OATP1B1.
Maltese: Eltrombopag huwa substrat għal BCRP, iżda mhuwiex substrat għall-glikoproteina-P jew għal OATP1B1.
English: In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringeport capability is provided.
Maltese: Għandha tiġi eżerċitata kawtela f'dawn il-pazjenti (ara sezzjoni 4.4).
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.
Maltese: Eltrombopag m'għandux jintuża f'pazjenti b'ITP b'indeboliment tal-fwied (punteġġ Child-Pugh ≥5) sakemm il-benefiċċju mistenni ma jkunx akbar mir-riskju identifikat ta' trombożi tal-vina portali.
English: Adults - the usual starting dose for hepatitis C is one 25 mg sachet of Revolade a day.
Maltese: Adulti - is-soltu d-doża tal-bidu għall-epatite Ċ hija qartas wieħed ta' 25 mg ta' Revolade kuljum.
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
Maltese: • problemi fis-sistema diġestiva inkluż: tħossok imdardar (rimettar), bdil fl-aptit (żieda jew tnaqqis), skumdità/uġigħ fl-istonku, stonku minfuħ, bass, tibdil fil-kulur tal-ippurgar
English: • bone pain
Maltese: • uġigħ fil-widnejn
English: Median platelet counts at baseline were 16,000/l for both treatment groups and in the eltrombopag group were maintained above 50,000/µl at all on-therapy visits starting at Day 15; in contrast, median platelet counts in the placebo group remained <30,000/µl throughout the study.
Maltese: L-għadd medjan ta' plejtlits fil-linja bażi kien ta' 16,000/l għaż-żewġ gruppi ta' kura u fil-grupp ta' eltrombopag kien miżmum ogħla minn 50,000/µl f'kull vista waqt it-terapija mill-Jum 15; b'kuntrast ma' dan, l-għadd medjan tal-plejtlits fil-grupp tal-plaċebo baqa' <30,000/µl matul l-istudju kollu.
English: • if you have another blood condition, such as myelodysplastic syndrome (MDS).
Maltese: • jekk għandek kundizzjoni oħra tad-demm, bħas-sindromu majelodisplastiku (MDS).
English: Revolade 50 mg film-coated tablets
Maltese: Revolade 50 mg pilloli miksija b'rita
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.
Maltese: Filfażi ta' kura pre- antivirali, il-pazjenti rċevew eltrombopag b'tikketta miftuħa biex l-għadd talplejtlits jiżdied għal ≥90,000/µl għal ENABLE 1 u ≥100,000/µl għal ENABLE 2.
English: • interruption in blood supply to spleen (splenic infarction)
Maltese: • tnaqqas fl-għadd ta' plejtlits (tromboċitopenja)
English: For patients of Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Maltese: F'każ ta' pazjenti b'dixxendenza Asjatika, eltrombopag għandu jibda jingħata b'doża mnaqqsa ta' 25 mg kuljum (ara sezzjoni 5.2).
English: Patients were diagnosed with ITP for at least 6 months and were refractory or relapsed to at least one prior ITP therapy with a platelet count <30,000/µl (n=67).
Maltese: Il-pazjenti nstabilhom li kellhom ITP għal mill-inqas 6 xhur u ma rrispondewx jew irkadew wara mill-inqas terapija waħda ta' ITP minn qabel b'għadd ta' plejtlits ta' <30,000/μl (n=67).