FrancophonIA/ELRC3.0 huggingface dataset:
English: 75 mg a AUC(0-) and Cmax based on population PK post-hoc estimates.
Maltese: 75 mg a l-AUC(0-) u s-Cmax ibbażati fuq stimi post-hoc ta' PK ta' popolazzjoni.
English: If you are of Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) you will start on the same 25 mg dose.
Maltese: Jekk inti ta' dixxendenza Asjatika (Ċiniż, Ġappuniż, mit-Tajwan, Tajlandiż jew Korean) se tibda fuq l-istess doża ta' 25 mg.
English: Musculosketal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Increase daily dose by 25 mg to a maximum of 100 mg/day.
Maltese: Żid id-doża ta' kuljum b'25 mg għal massimu ta' 100 mg/kuljum.
English: • decreased levels of blood albumin
Maltese: • tnaqqis fil-livelli ta' albumina fid-demm
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.
Maltese: Fi studji kliniċi b'agonist TPO-R f'pazjenti b'MDS, kienu osservati każijiet ta' żjidiet temporanji flgħadd taċ-ċelluli blastiċi u kienu rrappurtati każijiet ta' progressjoni tal-marda MDS għal-lewkimja majelojde akuta (AML).
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).
Maltese: Ir-rispons ematoloġiku jeħtieġ titrazzjoni tad-doża, ġeneralment sa 150 mg, u jista' jieħu sa 16il ġimgħa wara li jinbeda eltrombopag (ara sezzjoni 5.1).
English: Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation when receiving alfa interferon therapy.
Maltese: Pazjenti b'HCV kronika b'ċirrożi jistgħu jkunu f'riskju ta' dikumpensazzjoni epatika meta jirċievu terapija b'alfa interferon.
English: However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased preand post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Maltese: Madankollu, bid-doża tossika għall-omm ta' 60 mg/kg/kuljum (6 darbiet aktar mill-esponiment kliniku uman f'pazjenti b'ITP f'75 mg/kuljum u 3 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum ibbażat fuq l-AUC) fil-firien, il-kura b'eltrombopag kienet assoċjata ma' konsegwenza ta' mewt tal-embriju (żieda ta' telf qabel u wara l-implantazzjoni), tnaqqis fil-piż tal-ġisem tal-fetu u tal-utru tqil fl-istudju ta' fertiltià fin-nisa u inċidenza baxxa ta' kustilji ċervikali u tnaqqis fil-piż tal-ġisem tal-fetu fl-istudju tal-iżvilupp tal-embriju u l-fetu.
English: Hypersensitivity to eltrombopag or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal eltrombopag jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Patients with low albumin levels (≤35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients.
Maltese: Pazjenti b'livelli baxxi ta' albumina (≤ 35 g/l) jew MELD ≥ 10 kellhom riskju ta' darbtejn aktar ta' TEEs minn dawk b'livelli ogħla ta' albumina; dawk ta' ≥60 sena kellhom riskju ta' darbtejn aktar ta' TEEs meta mqabbla ma' pazjenti iżgħar.
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade a day.
Maltese: Adulti u tfal (6 sa 17-il sena) - is-soltu d-doża tal-bidu għal ITP hija żewġ qratas ta' 25 mg ta' Revolade kuljum.
English: Syringe tip
Maltese: TA' EĊĊIPJENTI
English: Patients achieving target platelet counts and initiating antiviral therapy c
Maltese: Pazjenti li kisbu l-għadd tal-plejtlits fil-mira u li bdew terapija antivirali c
English: Increase daily dose by 25 mg to a maximum of 75 mg/day*.
Maltese: Żid id-doża ta' kuljum b'25 mg għal massimu ta' 75 mg/kuljum*.
English: • increase in enzymes due to muscle breakdown (creatine phosphokinase)
Maltese: • żieda tal-enzimi minħabba tkissir tal-muskoli (fosfokinasi tal-kreatina)
English: • Pull back the plunger until all the medicine is in the syringe.
Maltese: • Iġbed il-planġer lura sakemm il-mediċina kollha tkun fis siringa.
English: The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label study (N=43) in which 11 patients (26%) were treated for >6 months and 7 patients (21%) were treated for >1 year.
Maltese: Is-sigurtà ta' eltrombopag f'anemija aplastika gravi tkejlet waqt studju open-label fost grupp wieħed ta' pazjenti (N=43) li minnhom 11-il pazjent (26%) kienu ttrattati għal >6 xhur u 7 pazjenti (21%) kienu ttrattati għal >sena.
English: The most common adverse reactions in paediatric ITP patients 1 year and older (≥3% and greater than placebo) were upper respiratory tract infection, nasopharyngitis, cough, pyrexia, abdominal pain, oropharyngeal pain, toothache and rhinorrhoea.
Maltese: L-aktar reazzjonijiet avversi komuni f'pazjenti pedjatriċi b'ITP ta' età minn sena 'l fuq (≥3% u aktar mill-plaċebo) kienu infezzjoni fl-apparat respiratorju ta' fuq, nażofarinġite, sogħla, deni, uġigħ fl-addome, uġigħ fil-ħalq u fil-farinġi, uġigħ fis-snien u rinorrea.
English: Nasopharyngitis
Maltese: Limfopenija
English: Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU' and ‘50' on one side.
Maltese: Il-pilloli miksijin b'rita Revolade 50 mg huma tondi, konvessi fuq iż-żewġ naħat, kannella u mnaqqxin b'‘GS UFU' u ‘50' fuq naħa waħda.
English: In RAISE and TRA100773B studies, in the subgroup of ITP patients with baseline platelet count ≤15,000/μl the median platelet counts did not reach the target level (>50,000/l), although in both studies 43% of these patients treated with eltrombopag responded after 6 weeks of treatment.
Maltese: Fl-istudji RAISE u TRA100773B, fis-sottogrupp ta' pazjenti b'ITP li fil-linja bażi kellhom għadd ta' plejtlits ≤15,000/μl, l-għadd medjan tal-plejtlits ma laħaqx il-livell fil-mira (>50,000/l), għalkemm fiż-żewġ studji 43% ta' dawn il-pazjenti kkurati b'eltrombopag irrispondew wara 6 ġimgħat ta' kura.
English: • medicines called statins, to lower cholesterol
Maltese: • mediċini msejħa statins, biex ibaxxu l-kolesterol
English: • muscle spasms
Maltese: • uġigħ fis-snien
English: For patients with HCV initiate eltrombopag at a dose of 25 mg once daily (see section 4.2).
Maltese: Għal pazjenti b'HCV ibda eltrombopag f'doża ta' 25 mg darba kuljum (ara sezzjoni 4.2).
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)].
Maltese: II b'eltrombopag b'doża inizjali ta' 50 mg/kuljum (li tiżdied kull ġimagħtejn sa massimu ta' 150 mg/kuljum) (ELT112523), l-inċidenza ta' anormalitajiet ċitoġenetiċi ġodda kienet osservata f'17.1% ta' pazjenti adulti [7/41 (fejn 4 minnhom kellhom tibdil fil-kromożoma 7)].
English: Eighty-six percent of patients were RBC transfusion dependent, and 91% were platelet transfusion dependent.
Maltese: Sitta u tmenin fil-mija tal-pazjenti kienu jiddependu minn trasfużjoni RBC, u 91% kienu jiddependu mit-trasfużjoni tal-plejtlits.
English: • pain in extremities (arms, legs, hands and feet)
Maltese: • uġigħ fl-estremitajiet (dirgħajn, riġlejn, idejn u saqajn)
English: Eltrombopag administration can cause abnormal liver function and severe hepatotoxicity, which might be life-threatening (see section 4.8).
Maltese: L-għoti ta' eltrombopag jista' jikkawża funzjoni tal-fwied mhux normali u tossiċità fil-fwied gravi, li tista' tkun ta' theddida għall-ħajja (ara sezzjoni 4.8).
English: Contents of the pack and other information Instructions for use
Maltese: Kontenut tal-pakkett u informazzjoni oħra Istruzzjonijiet dwar l-użu
English: Chronic hepatitis C associated thrombocytopenia studies
Maltese: Effetti ta' prodotti mediċinali oħra fuq eltrombopag Ciclosporin
English: Administration of a single 25 mg dose of eltrombopag as powder for oral suspension with a highcalcium, moderate-fat and moderate-calorie meal reduced plasma eltrombopag mean AUC0-∞ by 75% and mean Cmax by 79%.
Maltese: L-għoti ta' doża waħda ta' 25 mg ta' eltrombopag bħala trab għal suspensjoni orali ma' ikla b'ħafna kalċju, livell moderat ta' xaħam u livell moderat ta' kaloriji naqqas l-AUC0-∞ medja fil-plażma ta' eltrombopag b'75% u s-Cmax medja b'79%.
English: The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label study (N=43) in which 11 patients (26%) were treated for >6 months and 7 patients (16%) were treated for >1 year.
Maltese: Is-sigurtà ta' eltrombopag f'anemija aplastika gravi tkejlet waqt studju open-label fost grupp wieħed ta' pazjenti (N=43) li minnhom 11-il pazjent (26%) kienu ttrattati għal >6 xhur u 7 pazjenti (16%) kienu ttrattati għal >sena.
English: Common Asthenia, oedema peripheral, malaise
Maltese: Astenja, edima periferali, telqa
English: At ≥6 times the human clinical exposure in adult ITP patients at 75 mg/day and 3 times the human clinical exposure in adult HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 6 weeks and rats after 28 weeks of dosing.
Maltese: B'esponimenti ≥6 darbiet ogħla minn dak kliniku uman f'pazjenti adulti b'ITP f'75 mg/kuljum u 3 darbiet ogħla mill-esponiment kliniku uman f'pazjenti adulti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC , il-katarretti kienu osservati fil-ġrieden wara 6 ġimgħat u filfirien wara 28 ġimgħa ta' għoti tad-dożi.
English: Medicinal products for treatment of ITP
Maltese: Prodotti mediċinali għall-kura ta' ITP
English: Interactions are also expected with other HMG-CoA reductase inhibitors, including atorvastatin, fluvastatin, lovastatin, pravastatin and simvastatin.
Maltese: Interazzjonijiet huma mistennija wkoll b'impedituri oħra ta' HMG-CoA reductase, li jinkludu atorvastatin, fluvastatin, lovastatin, pravastatin u simvastatin.
English: IMPORTANT - Use the medicine immediately after you have mixed the powder with water.
Maltese: IMPORTANTI - Uża l-mediċina immedjatament wara li tkun ħallat it-trab mal-ilma.
English: Hepatic decompensation in patients with chronic hepatitis C: Monitoring is required in patients with low albumin levels (≤35 g/l) or with MELD score ≥10 at baseline.
Maltese: Hu meħtieġ monitoraġġ f'pazjenti b'livelli baxxi ta' albumina (≤ 35 g/l) jew b'punteġġ MELD ≥10 fil-linja bażi.
English: Revolade 75 mg film-coated tablets
Maltese: Revolade 75 mg pilloli miksija b'rita
English: 30 sachets and 1 mixing bottle + 30 single-use oral syringes
Maltese: 30 qartas u flixkun biex tħallat fih wieħed u 30 siringa orali li tintuża darba
English: Cough, oropharyngeal pain, rhinorrhoea
Maltese: Sogħla, uġigħ orofarinġeali, rinorrea
English: Revolade is not recommended during pregnancy.
Maltese: Revolade mhuwiex irrakkomandat waqt it-tqala.
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.
Maltese: Revolade jista' jikkawża riżultati fit-testijiet tad-demm li jistgħu jkunu sinjali ta' ħsara fil-fwiedżieda ta' xi enzimi tal-fwied, b'mod speċjali transaminases ta' bilirubin u alanine / aspartate.
English: 12.5 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Maltese: 12.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 12.5 mg eltrombopag.
English: Co-administration of a single dose of eltrombopag 200 mg with telaprevir 750 mg every 8 hours did not alter plasma telaprevir exposure.
Maltese: L-għoti flimkien ta' doża waħda ta' eltrombopag 200 mg ma' telaprevir 750 mg kull 8 sigħat ma bidilx l-esponiment ta' telaprevir fil-plasma.
English: The following side effects have been reported to be associated with treatment with Revolade in patients with severe aplastic anaemia (SAA):
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati li kellhom rabta mal-kura b'Revolade f'pazjenti b'anemija aplastika severa (SAA):
English: • milk or milk shakes, drinks containing milk, yoghurt or cream
Maltese: • ħalib u milk shakes, xarbiet li fihom il-ħalib, jogurt jew krema
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.
Maltese: • Żid 20 ml ta' ilma u l-kontenut tan-numru preskritt ta' qratas (skont id-doża rakkomandata)
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is one 50 mg tablet of Revolade a day.
Maltese: Adulti u tfal (6 sa 17-il sena) - is-soltu d-doża tal-bidu għal ITP hija pillola waħda ta' 50 mg ta' Revolade kuljum.
English: There are no PK data on the use of eltrombopag in patients ≥75 years.
Maltese: Ma hemm l-ebda dejta farmakokinetika dwar l-użu ta' eltrombopag f'pazjenti ≥75 sena.
English: EU/1/10/612/012 84 film-coated tablets (3 packs of 28)
Maltese: EU/1/10/612/010 (14-il pillola miksija b'rita) EU/1/10/612/011 (28 pillola miksija b'rita) EU/1/10/612/012 84 pillola miksija b'rita (3 pakketti ta' 28)
English: Eltrombopag should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus (see section 4.6).
Maltese: Madankollu ma jistax jiġi eskluż riskju għall-bnedmin (ara sezzjoni 5.3).
English: Cough♦ Common Oropharyngeal pain, rhinorrhoea Uncommon Pulmonary embolism, pulmonary infarction, nasal discomfort, oropharyngeal blistering, sinus disorder, sleep apnoea syndrome
Maltese: Emboliżmu fil-pulmun, infart fil-pulmun, skonfort fl-imnieħer, infafet fil-ħalq u fil-griżmejn, disturb fis-sinus, sindrome ta' apneja fl-irqad
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).
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 (ara sezzjoni 4.4).
English: Most patients receiving eltrombopag in combination with peginterferon / ribavirin therapy will experience indirect hyperbilirubinaemia.
Maltese: Il-biċċa l-kbira tal-pazjenti li jirċievu eltrombopag flimkien ma' terapija b'peginterferon/ribavirin se jkollhom iperbilirubinemija indiretta.
English: Haematologic malignancies
Maltese: Tumuri malinni ematoloġiċi
English: selenium and zinc
Maltese: Dawn jinkludu:
English: Eligible for efficacy analysis, n Patients with platelet count 50,000/l after up to 42 days of dosing (compared to a baseline count of <30,000/l), n (%)
Maltese: Eliġibbli għal analizi ta' effikaċja, n Pazjenti b'għadd tal-plejtlits 50,000/l wara mhux anqas minn 42 jum ta' għoti ta' dożi (meta mqabbel mal-għadd fillinja bażi ta' <30,000/l), n (%)
English: In both RAISE and TRA100773B the response to eltrombopag relative to placebo was similar irrespective of ITP medicinal product use, splenectomy status and baseline platelet count (≤15,000/µl, >15,000/µl) at randomisation.
Maltese: Kemm f'RAISE kif ukoll f'TRA100773B ir-rispons għal eltrombopag meta mqabbel mal-plaċebo kien jixxiebah irrispettivament mill-użu ta' prodott mediċinali għal ITP, minn jekk il-milsa tneħħietx jew le, u mill-għadd tal-plejtlits fil-linja bażi (≤15,000/µl, >15,000/µl) meta saret ir-randomisation.
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg sachet of Revolade a day.
Maltese: Tfal (1 sa 5 snin) - is-soltu d-doża tal-bidu għal ITP hija qartas wieħed ta' 25 mg ta' Revolade kuljum.
English: Revolade 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
Maltese: Revolade 75 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 75 mg ta' eltrombopag.
English: Data are limited to 21 out of the planned 60 patients with haematological responses reported by 52% of patients at 6 months.
Maltese: Id-dejta hi limitata għal 21 mis-60 pazjent ippjanati b'rispons ematoloġiku rrappurtat minn 52% tal-pazjenti fis-6 xahar.
English: Common Hepatic neoplasm malignant
Maltese: Biex tipprepara d-doża
English: Uncommon Dry mouth, glossodynia, abdominal tenderness, faeces discoloured, food poisoning, frequent bowel movements, haematemesis, oral discomfort
Maltese: Ħalq xott, glossodinja, sensittività fl-addome, ippurgar mingħajr kulur, avvelenament mill-ikel, ippurgar frekwenti, ematemesi, skonfort orali
English: Heat-sealed foil laminate sachets.
Maltese: OĦRA, JEKK MEĦTIEĠA
English: In a human radiolabel study, eltrombopag accounted for approximately 64% of plasma radiocarbon AUC0-.
Maltese: Fi studju uman radjutikkettat, eltrombopag kien jagħmel parti minn madwar 64% tal- AUC0-.tar-radjukarbon fil-plasma.
English: Eltrombopag dose (once daily)
Maltese: Doża ta' eltrombopag (darba kuljum)
English: White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3' and ‘25' on one side.
Maltese: Pillola miksija b'rita, konvessa miż-żewġ naħat, tonda, bajda (b'dijametru ta' madwar 10.3 mm), imnaqqxa b'‘GS NX3' u ‘25' fuq naħa waħda.
English: Common Blood bilirubin increased (hyperbilirubinemia), jaundice Not known Drug-induced liver injury* * Cases of drug-induced liver injury have been reported in patients with ITP and HCV
Maltese: Ħsara fil-fwied minħabba l-mediċina* * Każijiet ta' ħsara fil-fwied minħabba l-mediċina ġew irrappurtati f'pazjenti b'ITP u HCV
English: 75 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
Maltese: 75 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha eltrombopag olamine ekwivalenti għal 75 mg eltrombopag.
English: • decreased number of platelets (thrombocytopenia)
Maltese: • żieda fil-bilirubin (sustanza li jipprodiċiha l-fwied)
English: Common Dyspnoea, oropharyngeal pain, dyspnoea exertional, productive cough
Maltese: Dispneja, uġigħ orofarinġeali, dispneja waqt sforz, sogħla produttiva
English: Transaminases increased
Maltese: Żieda tat-transaminasi
English: CARTON OF 12.5 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' 12.5 mg - 14, 28, 84 (3 PAKKETTI ta' 28) PILLOLA
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).
Maltese: Katarretti ma ġewx osservati fi klieb adulti wara 52 ġimgħa ta' għoti ta' dożi f'darbtejn aktar mill-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u ekwivalenti għall-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC).
English: At poorly tolerated doses in rats and dogs (>10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and>4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short-term studies.
Maltese: F'dożi mhux ittollerati tajjeb fil-firien u fil-klieb (>10 jew 7 drabi l-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u >4 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC), tnaqqis fl-għadd tar-retikuloċiti u iperplasja riġenerattiva tal-eritrojdi fil-mudullun tal-għadam (firien biss) kienu osservati fl-istudji fuq perjodu qasir ta' żmien.
English: The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati li kellhom rabta mal-kura b'Revolade ma' peginterferon u ribavirin f'pazjenti b'HCV:
English: Adults - the usual starting dose for SAA is one 50 mg tablet of Revolade a day.
Maltese: Adulti - is-soltu d-doża tal-bidu għal SAA hija pillola waħda ta' 50 mg ta' Revolade kuljum.
English: Common Oral mucosal blistering, oral pain, vomiting, abdominal discomfort, constipation, abdominal distension, dysphagia, faeces discoloured, swollen tongue, gastrointestinal motility disorder, flatulence
Maltese: Infafet fil-mukożi orali, uġigħ fil-ħalq, rimettar, skumdità fladdome, konstipazzjoni, distensjoni fl-addome, diżfaġja, ippurgar mingħajr kulur, ilsien minfuħ, disturb fil-motalità gastrointestinali, gass
English: The effectiveness and safety of Revolade have not been established for the treatment of thrombocytopenia due to MDS.
Maltese: L-effettività u s-sigurtà ta' Revolade ma ġewx stabbiliti għat-trattament ta' tromboċitopenija minħabba MDS.
English: The median baseline platelet count was 19,000/l prior to eltrombopag administration.
Maltese: Il-medjan tal-għadd ta' plejtlits fil-linja bażi kien 19,000/l qabel ma ngħata eltrombopag.
English: • in the 4 hours before you take Revolade
Maltese: • fl-4 sigħat qabel ma tieħu Revolade
English: Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Maltese: Għandha tiġi eżerċitata kawtela meta eltrombopag jingħata lil pazjenti b'fatturi magħrufa ta' riskju għal tromboemboliżmu li jinkludu iżda li mhumiex limitati għal fatturi ta' riskju li ntirtu (eż. Fattur V Leiden) jew li ttieħdu (eż. defiċjenza ta' ATIII, sindrome antifosfolipidu), età avvanzata, pazjenti b'perijodi twal ta' immobilizzazzjoni, tumuri malinni, kontraċettivi u terapija ta' sostituzzjoni tal-ormoni, kirurġija/trawma, obeżità u tipjip.
English: The exposure at the lowest dose was 1.2 or 0.8 times the human clinical exposure based on AUC in adult or paediatric ITP patients at 75 mg/day and 0.6 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Maltese: L-esponiment bl-aktar doża baxxa kien 1.2 jew 0.8 drabi dak kliniku uman ibbażat fuq l-AUC f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u 0.6 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq lAUC.
English: Table 1 Dose adjustments of eltrombopag in ITP patients
Maltese: Tabella 1 Aġġustamenti fid-doża ta' eltrombopag f'pazjenti b'ITP
English: Decrease the daily dose by 50 mg.
Maltese: Naqqas id-doża ta' kuljum b'50 mg.
English: Patients with bleeding (WHO Grades 2-4) at any time during 6 months, n (%)
Maltese: Pazjenti bi fsada (Gradi 2-4 tal-WHO) fi kwalunkwe żmien waqt is-6 xhur, n (%)
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).
Maltese: Matul terapija antivirali, id-doża ta' eltrombopag għandha tiġi aġġustata kif meħtieġ biex jiġi evitat tnaqqis fid-doża ta' peginterferon minħabba tnaqqis fl-għadd tal-plejtlits li jista' jpoġġi l-pazjenti f'riskju ta' fsada (ara Tabella 2).
English: EXP Use within 30 minutes of reconstitution.
Maltese: JIS Uża sa 30 minuta wara r-rikostituzzjoni.
English: The powder for oral suspension may lead to higher eltrombopag exposure than the tablet formulation (see section 5.2).
Maltese: It-trab għal suspensjoni orali jista' jwassal għal esponiment ogħla għal eltrombopag millformulazzjoni tal-pillola (ara sezzjoni 5.2).
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg tablet of Revolade a day.
Maltese: Tfal (1 sa 5 snin) - is-soltu d-doża tal-bidu għal ITP hija pillola waħda ta' 25 mg ta' Revolade kuljum.
English: Method of administration (see section 6.6)
Maltese: Metodu ta' kif għandu jingħata (ara sezzjoni 6.6)