FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pull back on the plunger to the 10 ml mark on the syringe.
Maltese: • Iġbed il-planġer lura sal-marka ta' 10 ml fuq is-siringa.
English: Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS' and ‘75' on one side.
Maltese: Pillola miksija b'rita, konvessa miż-żewġ naħat, tonda, roża (b'dijametru ta' madwar 10.3 mm), imnaqqxa b'‘GS FFS' u ‘75' fuq naħa waħda.
English: These include:
Maltese: • IMPORTANTI:
English: In conclusion, taking into account the exposure margins based on AUC, a risk of eltrombopag-related cataracts in paediatric patients cannot be excluded.
Maltese: Bħala konklużjoni, meta jitqiesu l-marġnijiet ta' esponiment ibbażati fuq l-AUC, ma jistax jiġi eskluż riskju ta' katarretti relatati ma' eltrombopag f'pazjenti pedjatriċi.
English: This was measured by delayed phototoxic index.
Maltese: Dan tkejjel permezz ta' indiċi fototossiċi mdewwma.
English: Headache, dizziness
Maltese: Stat konfużjonali, aġitazzjoni
English: Data presented as geometric mean (95% CI).
Maltese: Dejta ppreżentata bħala medja ġeometrika (95% CI).
English: Common Irritability, pain, malaise, injection site reaction, non-cardiac chest pain, oedema, oedema peripheral
Maltese: Irritabilità, uġigħ, telqa, reazzjoni fis-sit tal-injezzjoni, uġigħ fissider mhux kardijaku, edema, edema periferali
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.
Maltese: • Revolade jista' jintuża wkoll għall-kura ta' għadd baxx tal-plejtlits (tromboċitopenija) f'adulti b'infezzjonijiet tal-virus tal-epatite Ċ (HCV), jekk kellhom problemi bl-effetti sekondarji meta kienu qed jirċievu trattament b'interferon.
English: 30 single-use oral dosing syringes
Maltese: 30 siringa għal dożaġġ orali li tintuża darba
English: Patients were randomised 2:1 and received Revolade (n=63) or placebo (n=29) for up to 13 weeks in the randomised period of the study.
Maltese: Il-pazjenti kienu randomizzati 2: 1 u ngħataw Revolade (n=63) jew plaċebo (n=29) għal sa 13-il ġimgħa fil-perjodu randomizzat talistudju.
English: • decreased levels of calcium
Maltese: • tnaqqis fil-livelli tal-kalċju
English: Nausea, diarrhoea
Maltese: Nawsja, dijarea
English: • problems with balance, speech and nerve function, shaking
Maltese: • problemi bil-bilanċ, bit-taħdit u bil-funzjoni tan-nervituri, tregħid
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali u forom oħra ta' interazzjoni
English: Arthralgia, pain in extremity, muscle spasms
Maltese: Artralġja, uġigħ fl-estremitajiet, spażmi fil-muskoli
English: In both HCV studies, a significantly greater proportion of patients treated with eltrombopag (n=201, 21%) achieved SVR compared to those treated with placebo (n=65, 13%) (see Table 7).
Maltese: Fiż-żewġ studji ta' HCV, kien hemm proporzjon ferm akbar ta' pazjenti li rċevew kura b'eltrombopag (n=201, 21%) li kisbu SVR meta mqabbla ma' dawk li rċevew kura bi plaċebo (n=65, 13%) (ara Tabella 7).
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).
Maltese: Iperostosi endosteali kienet osservata fi studju ta' tossiċità ta' 28 ġimgħa fil-firien bid-doża mhux ittollerata tajjeb ta' 60 mg/kg/kuljum (6 darbiet jew 4 darbiet aktar mill-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi 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).
English: Combination with direct-acting antiviral agents
Maltese: Kombinazzjoni ma' aġenti antivirali b'azzjoni diretta
English: Common Blood alkaline phosphatase increased Uncommon Blood albumin increased, protein total increased, blood albumin decreased, pH urine increased
Maltese: Żieda fl-albumina fid-demm, żieda fit-total ta' proteina, tnaqqis fl-albumina fid-demm, żieda fil-pH tal-awrina
English: In eltrombopag clinical studies in ITP thromboembolic events were observed at low and normal platelet counts.
Maltese: Fi studji kliniċi b'eltrombopag f'ITP kienu osservati avvenimenti tromboemboliċi f'għadd baxx u normali tal-plejtlits.
English: The tablets should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Maltese: Is-sospensjoni għandha tittieħed mill-inqas sagħtejn qabel jew erba' sigħat wara xi prodotti bħal antaċidi, prodotti magħmula mill-ħalib (jew prodotti oħra tal-ikel li fihom il-calcium), jew supplimenti ta' minerali li għandhom katjoni polivalenti (eż. ħadid, kalċju, manjeżju, aluminju, selenju u żingu) (ara sezzjonijiet 4.5 u 5.2).
English: 30 sachets of powder
Maltese: 30 qartas bit-trab
English: Loss of response to eltrombopag
Maltese: Telf ta' rispons għal eltrombopag
English: The most common adverse reactions occurring in at least 10% of patients included headache, anaemia, decreased appetite, cough, nausea, diarrhoea, hyperbilirubinaemia, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and oedema.
Maltese: L-aktar reazzjonijiet avversi komuni li kien hemm f'mill-inqas10% tal-pazjenti kienu jinkludu uġigħ ta' ras, anemija, tnaqqis fl-aptit, sogħla, dardir, dijarrea, iperbilirubinemija, allopeċja, ħakk, uġigħ fil-muskoli, deni, għeja, mard li jixbah lillinfluwenza, astenja, dehxiet u edima.
English: In the 3 controlled clinical ITP studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 8% and 8% of the eltrombopag and placebo groups, respectively (see section 4.4).
Maltese: Fit-3 studji kliniċi kkontrollati ta' ITP, tnaqqis għal żmien qasir fl-għadd tal-plejtlits għal livelli aktar baxxi mill-linja bażi ġew osservati meta twaqqfet il-kura fi 8% u 8% tal-gruppi ta' eltrombopag u ta' plaċebo, rispettivament (ara sezzjoni 4.4).
English: Component of a multipack, can't be sold separately.
Maltese: Jagħmel parti minn pakkett multiplu, ma jistgħux jinbiegħu separatament.
English: Hepatic decompensation (use with interferon)
Maltese: Dikumpensazzjoni epatika (użu ma' interferon)
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc.
Maltese: Eltrombopag jikkela ma' katjoni polivalenti bħal ħadid, kalċju, manjeżju, aluminju, selenju u żingu.
English: Immune (primary) thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: If platelet counts drop to <30,000/µl, haemoglobin drops to < 9 g/dl or absolute neutrophil count (ANC) <0.5 x 10
Maltese: Jekk l-għadd tal-plejtlits jinżel għal <30,000/µl taqtira ta' emoglobina għal < 9 g/dl jew l-għadd assolut ta' newtrofili (ANC) <0.5 x 10
English: Paediatric population (aged 1 to 17 years) The safety and efficacy of eltrombopag in paediatric patients have been investigated in two studies.
Maltese: Popolazzjoni pedjatrika (età minn sena sa 17-il sena) Is-sigurtà u l-effikaċja ta' eltrombopag f'pazjenti pedjatriċi kienu investigati f'żewġ studji.
English: Revolade 75 mg film-coated tablets eltrombopag
Maltese: Revolade 75 mg pilloli miksija b'rita eltrombopag
English: White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1' and ‘12.5' on one side.
Maltese: Pillola miksija b'rita, konvessa miż-żewġ naħat, tonda, bajda (b'dijametru ta' madwar 7.9 mm), imnaqqxa b'‘GS MZ1' u ‘12.5' fuq naħa waħda.
English: There are limited data on the use of Revolade in patients aged 65 years and older.
Maltese: Hemm dejta limitata dwar l-użu ta' Revolade f'pazjenti li għandhom 65 sena jew aktar.
English: The proportion of eltrombopag-treated patients with any bleeding (Grades 1-4) and clinically significant bleeding (Grades 2-4) was reduced from baseline by approximately 50% from Day 15 to the end of treatment throughout the 6-month treatment period.
Maltese: Il-proporzjon ta' pazjenti kkurati b'eltrombopag b'xi fsada (Gradi 1-4) u fsada sinifikanti b'mod kliniku (Gradi 2-4) tnaqqas mill-linja bażi b'madwar 50% mill-Jum 15 sa tmiem ilkura matul il-perjodu kollu ta' 6 xhur ta' kura.
English: In clinical studies with eltrombopag, a dose reduction of statins by 50% was recommended.
Maltese: Fi studji kliniċi b'eltrombopag, kien irrakkomandat tnaqqis ta' 50% fid-doża tal-istatins.
English: The median time on study to a cytogenetic abnormality was 2.9 months.
Maltese: Iż-żmien medjan tal-istudju għal anormalità ċitoġenetika kien ta' 2.9 xhur.
English: Ninety-two patients were randomised by three age cohort strata (2:1) to eltrombopag (n=63) or placebo (n=29).
Maltese: Tnejn u disgħin pazjent intgħażlu b'mod randomised skont tliet strati ta' koorti ta' età (2:1) għal eltrombopag (n=63) jew plaċebo (n=29).
English: • foamy, frothy or bubbly-looking urine (signs of protein in urine)
Maltese: • awrina bir-ragħwa jew bil-bżieżaq (sinjali ta' proteina fl-awrina)
English: • black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people)
Maltese: • ippurgar iswed qisu qatran (movimenti tal-imsaren mingħajr kulur huma effett sekondarju mhux komuni li jista' jaffettwa sa persuna 1 minn kull 100)
English: In a placebo-controlled study (n=288, Safety population), following 2 weeks' treatment in preparation for invasive procedures, 6 of 143 (4%) adult patients with chronic liver disease receiving eltrombopag experienced 7 TEEs of the portal venous system and 2 of 145 (1%) patients in the placebo group experienced 3 TEEs.
Maltese: Fi studju kkontrollat bi plaċebo (n=288, Popolazzjoni ta' sigurtà), wara ġimagħtejn ta' kura bi preparazzjoni għal proċeduri invażivi, 6 mill 143 (4%) pazjent adult b'mard kroniku tal-fwied li kienu qed jirċievu eltrombopag kellhom 7 TEEs fis-sistema tal-vini portali u 2 pazjenti minn 145 (1%) fil-grupp ta' plaċebo kellhom 3 TEEs.
English: Common Hyperglycaemia, abnormal loss of weight
Maltese: Ipergliċemija, telf abnormali fil-piż
English: • joint pain (arthralgia)
Maltese: • uġigħ fil-ġogi (artralġja)
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)].
Maltese: II b'eltrombopag b'doża ta' 150 mg/kuljum (b'modifiki etniċi jew relatati mal-età kif indikat) (ELT116826), l-inċidenza ta' anormalitajiet ċitoġenetiċi ġodda kienet osservata fi 22.6% tal-pazjenti adulti [7/31 (fejn 3 minnhom kellhom tibdil fil-kromożoma 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
Maltese: Rimettar, axxite, uġigħ addominali, uġigħ fin-naħa ta' fuq taladdome, dispepsja, ħalq xott, stitikezza, nefħa addominali, uġigħ fis-snien, stomatite, mard tar-rifluss gastroesofagali, murliti, skumdità addominali, variċi esofagali
English: Renal tubular toxicity was observed in studies of up to 14 days duration in mice and rats at exposures that were generally associated with morbidity and mortality.
Maltese: Tossiċità tubulari tal-kliewi kienet osservata fi studji li damu għaddejjin sa 14-il jum fil-ġrieden u lfirien f'esponimenti li kienu ġeneralment assoċjati ma' morbidità u mortalità.
English: Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).
Maltese: Revolade hu indikat f'pazjenti adulti b'infezzjoni kronika tal-virus tal-epatite Ċ (HCV) għall-kura ta' tromboċitopenja, meta l-grad tat-tromboċitopenja huwa l-fattur ewlieni li jwaqqaf il-bidu jew li jillimita l-kapaċità li tinżamm terapija ottimali bbażata fuq interferon (ara sezzjonijiet 4.4 u 5.1).
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).
Maltese: Eltrombopag ma kkawżax kanċer fil-ġrieden b'dożi sa 75 mg/kg/kuljum jew fil-firien b'dożi sa 40 mg/kg/kuljum (esponimenti sa 4 darbiet jew darbtejn aktar mill-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi 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).
English: Haematological response was defined as meeting one or more of the following criteria: 1) platelet count increases to 20,000/µl above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks; 2) haemoglobin increase by >1.5g/dl, or a reduction in ≥4 units of red blood cell (RBC) transfusions for 8 consecutive weeks; 3) absolute neutrophil count (ANC) increase of 100% or an ANC increase >0.5 x 10
Maltese: Ir-rispons ematoloġiku kien iddefinit bħala li ntlaħaq wieħed, jew aktar, mill-kriterji li ġejjin: 1) żieda fl-għadd ta' plejtlits għal 20,000/µl 'il fuq mil-linja bażi jew għadd stabbli ta' plejtlits b'indipendenza trasfużjonali għal mill-inqas 8 ġimgħat; 2) żieda fl-emoglobina b'> 1.5 g/dl, jew tnaqqis fit-trasfużjoni b'≥4 unitajiet ta' ċelloli ħomor tad-demm (RBC) għal 8 ġimgħat wara xulxin; 3) żieda ta' 100% fl-għadd assolut ta' newtrofili (ANC) jew żieda fl-ANC ta' > 0.5 x 10
English: Revolade 25 mg powder for oral suspension
Maltese: Revolade 25 mg trab għal suspensjoni orali
English: • liver problems
Maltese: • tnaqqis fil-livell ta' emaglobina
English: In the clinical studies of eltrombopag, overall no clinically significant differences in safety of eltrombopag were observed between patients aged at least 65 years and younger patients.
Maltese: Fl-istudji kliniċi ta' eltrombopag, globalment ma kinux innutati differenzi sinifikanti b'mod kliniku fis-sigurtà ta' eltrombopag bejn pazjenti li kellhom mill-anqas 65 sena u pazjenti iżgħar.
English: Patients with diagnosis of Fanconi anaemia, infection not responding to appropriate therapy, PNH clone size in neutrophils of ≥50%, where excluded from participation.
Maltese: Pazjenti b'dijanjożi ta' anemija Fanconi, infezzjoni li ma tirrispondix għal terapija xierqa, bid-daqs tal-klonu PNH fin-newtrofili ta' ≥50%, kienu esklużi milli jieħdu sehem.
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 Ear and labyrinth disorders Common Ear pain, vertigo Cardiac disorders
Maltese: Opaċitajiet tal-lenti, astigmatiżmu, katarretta fil-kortiċi, żieda filproduzzjoni tad-dmugħ, emorraġija mir-retina, epiteljopatija talpigment tar-retina, riżultati ta' testijiet tal-akutezza tal-vista mhux normali, blefarite u keratokonjunktivite sicca
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.
Maltese: Il-pilloli miksija b'rita Revolade 12.5 mg huma tondi, konvessi fuq iż-żewġ naħat, bojod, u mnaqqxin b'‘GS MZ1' u ‘12.5' fuq naħa waħda.
English: 25 mg powder for oral suspension
Maltese: 25 mg trab għal suspensjoni orali
English: Uncommon side effects that may show up in laboratory tests:
Maltese: Effetti sekondarji mhux komuni li jistgħu jidhru fit-testijiet tal-laboratorju:
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo).
Maltese: Trombożi fil-vina portali kienet l-aktar TEE komuni fiż-żewġ gruppi ta' kura (2% f'pazjenti li rċevew kura b'eltrombopag kontra <1% għall-plaċebo).
English: • sleep disorders, abnormal drowsiness, depression, anxiety
Maltese: • disturbi fl-irqad, ħedla anormali, dipressjoni, ansjetà
English: Other secondary findings of the studies included the following: significantly fewer patients treated with eltrombopag prematurely discontinued antiviral therapy compared to placebo (45% vs. 60%, p=<0.0001).
Maltese: Sejbiet sekondarji oħra tal-istudji kienu jinkludu dan li ġej: ferm inqas pazjenti li rċevew kura b'eltrombopag waqqfu t-terapija antivirali b'mod prematur meta mqabbla ma' plaċebo (45% kontra 60%, p=<0.
English: When treatment is considered appropriate, caution is required when administering eltrombopag to patients with hepatic impairment (see sections 4.2 and 4.8).
Maltese: Jekk ikun hemm anormalitajiet ċitoġenetiċi ġodda, wieħed għandu jqis jekk jixraqx li tieqaf tieħu eltrombopag (ara sezzjonijiet 4.4 u 4.8).
English: Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Revolade.
Maltese: Xi persuni ikollhom fsada fis-sistema diġestiva wara li jiefqu jieħdu peginterferon, ribavirin, u Revolade.
English: Tubular toxicity was also observed in a 2-year oral carcinogenicity study in mice at doses of 25, 75 and 150 mg/kg/day.
Maltese: It-tossiċità tubulari kienet osservata wkoll fi studju dwar ir-riskju ta' kanċer b'għoti mill-ħalq li dam sejjer sentejn fi ġrieden b'dożi ta' 25, 75 u 150 mg/kg/kuljum.
English: Across the 3 placebo-controlled studies in adults with chronic ITP, 1 patient in the placebo group and 1 patient in the eltrombopag group experienced a Grade 4 liver test abnormality.
Maltese: Fit-3 studji kkontrollati bi plaċebo f'adulti b'ITP kronika, pazjent wieħed fil-grupp tal-plaċebo u pazjent wieħed fil-grupp ta' eltrombopag esperjenzaw anormalità fit-test tal-fwied ta' Grad 4.
English: • minerals such as iron, calcium, magnesium, aluminium, selenium and zinc which may be found in vitamin and mineral supplements (see also ‘When to take it' in section 3)
Maltese: • minerali bħal ma huma ħadid, kalċju, manjeżju, aluminju, selenju u żingu li jistgħu jinstabu f'supplimenti tal-vitamini u l-minerali (ara wkoll ‘Meta għandek tieħdu' fis-sezzjoni 3)
English: Eltrombopag is highly coloured and so has the potential to interfere with some laboratory tests.
Maltese: Eltrombopag huwa kkulurit ħafna u għalhekk għandu l-potenzjal li jinterferixxi ma' xi testijiet tallaboratorju.
English: • The medicine is a dark brown liquid.
Maltese: • Il-mediċina hija likwidu kannella skur.
English: Revolade 50 mg film-coated tablets EU/1/10/612/004
Maltese: Revolade 50 mg pilloli miksija b'rita EU/1/10/612/004
English: What Revolade looks like and contents of the pack Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a reddish-brown to yellow powder.
Maltese: Revolade 25 mg trab għal suspensjoni orali huwa disponibbli f'kits li fihom 30 qartas; kull qartas fih trab kannella fl-aħmar sa isfar.
English: Preparation and administration of the powder for oral suspension:
Maltese: Preparazzjoni u għoti tat-trab għal suspensjoni orali:
English: Immune (primary) thrombocytopenia (ITP) studies
Maltese: Studji fuq tromboċitopenja immuni (primarja)
English: • toothache
Maltese: • ħżiża
English: Serum discolouration and interference with total bilirubin and creatinine testing have been reported in patients taking Revolade.
Maltese: Ġew irrappurtati tibdil fil-kulur tas-serum u interferenza mal-ittestjar tal-bilirubin u lkreatinina totali f'pazjenti li ħadu Revolade.
English: †, hyperbilirubinaemia,
Maltese: ♦, rimettar, uġigħ fl-addome*,
English: Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times or 8 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 7 times the human clinical exposure in HCV patients at 100 mg/day, based on Cmax).
Maltese: Eltrombopag ma kienx mutaġeniku jew klastoġeniku f'analiżi ta' mutazzjoni fil-batterji jew f'żewġ analiżi in vivo fil-firien (mikronukleju u sinteżi tad-DNA mhux skedata, 10 darbiet jew 8 darbiet aktar mill-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u 7 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq is-Cmax).
English: Platelet counts >75,000/µl should be avoided.
Maltese: Għadd tal-plejtlits >75,000/μl għandu jiġi evitat.
English: Eltrombopag did not affect female fertility, early embryonic development or embryofoetal development in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure in adult or adolescent (12-17 years old) ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Maltese: Eltrombopag m'affettwax il-fertilità fin-nisa, l-iżvilupp bikri tal-embriju jew l-iżvulupp tal-embriju u tal-fetu fil-firien b'dożi sa 20 mg/kg/kuljum (darbtejn aktar mill-esponiment kliniku uman filbnedmin f'pazjenti adulti jew adolexxenti (età ta' 12-17-il sena) 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: ♦, vomiting, abdominal pain*, mouth haemorrhage, flatulence * Very common in paediatric ITP
Maltese: Deni*, uġigħ fis-sider, astenja *Komui ħafna f'ITP pedjatrika
English: Furthermore, a clinical pharmacology study in 36 subjects showed no evidence that photosensitivity was increased following administration of eltrombopag 75 mg.
Maltese: Barra minn hekk, studju farmakoloġiku kliniku ta' f'36 individwu ma wera lebda evidenza li l-fotosensittività żdiedet wara l-għoti ta' eltrombopag 75 mg.
English: Medicinal products that inhibit or induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations, whereas medicinal products that inhibit or induce multiple enzymes have the potential to increase (e.g. fluvoxamine) or decrease (e.g. rifampicin) eltrombopag concentrations.
Maltese: Prodotti mediċinali li jinibixxu jew li jinduċu enzima unika mhumiex probabbli li jaffettwaw b'mod sinifikanti l-konċentrazzjonijiet ta' eltrombopag fil-plasma, filwaqt li prodotti mediċinali li jinibixxu jew li jinduċu enzimi multipli għandhom il-potenzjal li jżidu (eż. fluvoxamine) jew inaqqsu (eż. rifampicin) il-konċentrazzjonijiet ta' eltrombopag.
English: During the randomised period of the study, patients were randomised by three age cohort strata (2:1) to eltrombopag (n=45) or placebo (n=22).
Maltese: Matul il-perjodu randomised talistudju, il-pazjenti kienu randomised skont tliet strati ta' koorti ta' età (2:1) għal eltrombopag (n=45) jew plaċebo (n=22).
English: • If you spill any powder or liquid, clean it up with a damp cloth (see step 14 of the instructions).
Maltese: • Jekk ixxerred xi trab jew likwidu, naddfu b'ċarruta niedja (ara pass 14 tal-istruzzjonijiet).
English: • 25 mg dose - 1 sachet
Maltese: • Doża ta' 25 mg- qartas wieħed
English: • vomiting
Maltese: • emigranja
English: • sunburn
Maltese: • nawsja
English: Common Petechiae, rash, pruritus, urticaria, skin lesion, rash macular Not known Skin discolouration, skin hyperpigmentation
Maltese: Petechiae, raxx, ħakk, urtikarja, feriti fil-ġilda, raxx makulari
English: Revolade 25 mg film-coated tablets EU/1/10/612/001
Maltese: Revolade 25 mg pilloli miksija b'rita EU/1/10/612/001
English: Following discontinuation of therapy, patients should be monitored for any signs or symptoms of gastrointestinal bleeding.
Maltese: Wara t-twaqqif tatterapija, il-pazjenti għandhom jiġu mmonitorjati għal xi sinjali jew sintomi ta' fsada gastrointestinali.
English: Avoid direct contact with the medicine.
Maltese: Evita kuntatt dirett mal-mediċina.