FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Tasermity?
Maltese: X'inhuma r-riskji assoċjati ma' Tasermity?
English: Tasermity is a medicine used to control hyperphosphataemia (high blood phosphate levels) in adult patients on dialysis (a blood clearance technique).
Maltese: Tasermity huwa mediċina li tintuża biex tikkontrolla iperfosfatemija (livelli għoljin ta' fosfat fid-demm) f'pazjenti adulti li jkunu qegħdin jagħmlu dijaliżi (teknika tat-tisfija tad-demm).
English: The company that makes Renagel has agreed that its scientific data can be used for Tasermity (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Renagel qablet li d-data xjentifika tagħha tista' tintuża għal Tasermity (‘kunsens infurmat').
English: Tasermity sevelamer hydrochloride
Maltese: Sommarju tal-EPAR għall-pubbliku sevelamer kloridrat
English: Similar results with Tasermity were seen in another 8-week study involving 172 haemodialysis patients, while in a third longer-term study (over 44 weeks) Tasermity led to an average fall of 0.71 mmol/l.
Maltese: Riżultati simili b'Tasermity kienu osservati fi studju ieħor ta' 8 ġimgħat li kien jinvolvi 172 pazjent li kienu fuq emodijaliżi, filwaqt li fit-tielet studju fuq żmien itwal (fuq 44 ġimgħa) Tasermity wassal għal tnaqqis medju ta' 0.71 mmol/l.
English: For the full list of all side effects and restrictions with Tasermity, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Tasermity, ara l-fuljett ta' tagħrif.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasermity on 26 February 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tasermity fis-26 ta' Frar 2015.
English: When taken with meals, the sevelamer molecules in Tasermity attach in the gut to phosphate from food, preventing it from being absorbed into the body.
Maltese: Meta jittieħed malikel, il-molekuli ta' sevelamer f'Tasermity jeħlu fl-imsaren mal-fosfat mill-ikel, li jwaqqfuh milli jiġi assorbit fil-ġisem.
English: This medicine is the same as Renagel, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Renagel, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Tasermity must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Maltese: Tasermity m'għandux jintuża minn persuni li għandhom ipofosfatemija (livelli baxxi ta' fosfat fiddemm) jew ostruzzjoni fil-musrana (imsaren miżdudin).
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Maltese: Jista' jintuża f'pazjenti li jkunu qegħdin jagħmlu emodijaliżi (permezz ta' magna li tiffiltra d-demm) jew dijaliżi peritoneali (fejn il-fluwidu jiġi ppumpjat fiż-żaqq u membrana interna tiffiltra d-demm).
English: EU Number Invented name Strength
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: 1.5 - 3.1 ml 1 vial
Maltese: Kunjett (tazza) 1.5 - 3.1 ml
English: Intravenous use
Maltese: Kontenut
English: 2 to 4 GBq per vial at calibration date
Maltese: GBq/kunjett fid-data ta' referenza soluzzjoni għallinjezzjoni
English: Vial (glass)
Maltese: Użu għal ġolvini
English: Pharmaceutical form Route of administration Packaging Content
Maltese: Għamla farmaċewtika
English: This is normal.)
Maltese: Dan huwa normali.)
English: Genotype 1/4/6
Maltese: Ġenotip 1/4/6
English: IMPORTANT:
Maltese: IMPORTANTI:
English: Albumin levels f
Maltese: Livelli ta' albumina f
English: System organ class
Maltese: Sistema tal-klassifika talorgani
English: • increased band neutrophils
Maltese: • żieda fil-band neutrophils
English: Total number of patients entering antiviral treatment phase n=956 n=485 n=450 n=232 n=506 n=253
Maltese: Għadd totali ta' pazjenti li daħlu filfażi ta' kura antivirali n=956 n=485 n=450 n=232 n=506 n=253
English: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nuremberg, Germany
Maltese: Novartis Pharma GmbH, Roonstraße 25, D-90429 Nuremberg, Il-Ġermanja
English: Double-blind placebo-controlled studies
Maltese: Studji double-blind ikkontrollati bi plaċebo
English: Table 7 Virologic response in HCV patients in ENABLE 1 and ENABLE 2
Maltese: Tabella 7 Rispons viroloġiku f'pazjenti b'HCV f'ENABLE 1 u ENABLE 2
English: Glaxo Wellcome S.A. Avenida de Extremadura 3 09400 Aranda de Duero Burgos
Maltese: Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanja
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanja Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit
English: Table 5 Efficacy results from TRA100773B
Maltese: Riżultati ta' effikaċja minn TRA100773B
English: Table 4 Secondary efficacy results from RAISE
Maltese: Tabella 4 Riżultati ta' effikaċja sekondarja minn RAISE
English: Eltrombopag is metabolised through multiple pathways including CYP1A2, CYP2C8, UGT1A1, and UGT1A3 (see section 5.2).
Maltese: Eltrombopag jiġi metabolizzat permezz ta' diversi passaġġi inkluż CYP1A2, CYP2C8, UGT1A1 u UGT1A3 (ara sezzjoni 5.2).
English: HCV RNA Genotype Genotype 2/3
Maltese: Ġenotip tal-HCV RNA Ġenotip 2/3
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Maltese: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Ir-Renju Unit
English: 12 to 17 years (n=62)
Maltese: 12 sa 17-il sena (n=62)
English: Placebo n/N (%) [95% CI]
Maltese: Plaċebo n/N (%) [CI ta' 95%]
English: Date of first authorisation: 11 March 2010 Date of latest renewal: 15 January 2015
Maltese: Data tal-aħħar tiġdid: 15 ta' Jannar 2015
English: Polyvalent cations (chelation)
Maltese: Katjoni polivalenti (kelazzjoni)
English: Progression of existing myelodysplastic syndrome (MDS)
Maltese: Progressjoni ta' sindromi mijelodisplastiċi (MDS) eżistenti
English: ENABLE 1 utilised peginterferon alfa-2a plus ribavirin for antiviral treatment and ENABLE 2 utilised peginterferon alfa-2b plus ribavirin.
Maltese: ENABLE 1 uża peginterferon alfa-2a flimkien ma' ribavirin għall-kura antivirali u ENABLE 2 uża peginterferon alfa-2b flimkien ma' ribavirin.
English: OATP1B1 and BCRP substrates
Maltese: Sustrati ta' OATP1B1 u BCRP
English: The active substance in Revolade is eltrombopag.
Maltese: Is-sustanza attiva f'Revolade hi eltrombopag.
English: Eltrombopag n/N (%) [95% CI]
Maltese: Eltrombopag n/N (%) [CI ta' 95%]
English: • flu (influenza)
Maltese: • riħ (influwenza)
English: EU/1/10/612/013 (30 sachets of powder for oral suspension)
Maltese: EU/1/10/612/013 (30 qartas ta' trab għal suspensjoni orali)
English: Revolade 75 mg film-coated tablets also contain iron oxide red (E172) and iron oxide black (E172).
Maltese: Revolade 75 mg film-coated tablets also contain iron oxide red (E172) u iron oxide black (E172).
English: 6 to 11 years (n=68)
Maltese: 6 sa 11-il sena (n=68)
English: p-value a
Maltese: Valur-p a
English: HCV protease inhibitors
Maltese: Inibituri ta' HCV protease
English: Placebo N=62
Maltese: Plaċebo N=62
English: Absorption and bioavailability
Maltese: Assorbiment u bijodisponibbiltà
English: • progressive, or
Maltese: • progressivi, jew
English: Phototoxicity
Maltese: Fototossiċità
English: Cohort 1 (12 to 17 years)
Maltese: Koorti 1 (12 sa 17-il sena)
English: Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years on study were 85,000/l, 85,000/l, 105,000/l, 64,000/l, 75,000/l, 119,000/l and 76,000/l, respectively.
Maltese: Il-medjan tal-għadd tal-plejtlits f'1, 2, 3, 4, 5, 6 u 7 snin waqt l-istudju kien 85,000/l, 85,000/l, 105,000/l, 64,000/l, 75,000/l, 119,000/l u 76,000/l, rispettivament.
English: • Administer the oral suspension immediately after preparation.
Maltese: • Agħti s-suspensjoni orali immedjatament wara l-preparazzjoni.
English: Cohort 2 (6 to 11 years)
Maltese: Koorti 2 (6 sa 11-il sena)
English: Carcinogenicity and mutagenicity
Maltese: Karċinoġeniċità u mutaġeniċità
English: Eltrombopag was an inhibitor of a number of UGT enzymes in vitro.
Maltese: Eltrombopag kien impeditur ta' numru ta' enzimi UGT in vitro.
English: 30 sachets.
Maltese: 30 qartas.
English: Cytochrome P450 substrates
Maltese: Sustrati taċ-ċitokroma P450
English: Requiring rescue therapy, n (%) p-value a
Maltese: Dawk li ħtieġu terapija ta' salvataġġ, n (%) Valur-p a
English: The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Maltese: Is-sustanzi l-oħra huma: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
English: Interference with laboratory tests
Maltese: Interferenza mat-testijiet tal-laboratorju
English: Marketing authorisation holder Novartis Europharm Limited Vista Building
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Novartis Europharm Limited Vista Building
English: The pharmacokinetics of eltrombopag have been evaluated in 168 paediatric ITP patients dosed once daily in two studies, TRA108062/PETIT and TRA115450/PETIT-2.
Maltese: Il-farmakokinetika ta' eltrombopag ġiet evalwata f'168 pazjent pedjatriku b'ITP li ngħataw doża darba kuljum f'żewġ studji, TRA108062/PETIT u TRA115450/PETIT-2.
English: Severe aplastic anaemia in adult patients
Maltese: Anemija aplastika severa f'pazjenti adulti
English: Multilineage responses were reported by 45% of patients.
Maltese: Rispons multilineali kien irrappurtat minn 45% talpazjenti.
English: ATC code: B02BX 05.
Maltese: B02BX
English: Placebo N=38
Maltese: Plaċebo N=38
English: The laminate material is comprised of polyester (PET) / orientated polyamide (OPA) / 9 µm aluminium foil (AL) / low density polyethylene heat seal layer (LDPE).
Maltese: Il-materjal illiminat hu magħmul millpolyester (PET) / polyamide orjentat (OPA) / 9 µm fojl tal-aluminju (AL) / lega ta' polyethylene b'densità baxxa ssiġillata bis-sħana (LDPE).
English: Eltrombopag is highly bound to human plasma proteins (>99.9%), predominantly to albumin.
Maltese: Eltrombopag jintrabat b'mod qawwi mal-proteini tal-plasma umani (>99.9%), il-biċċa l-kbira malalbumina.
English: Revolade 12.5 mg, 25 mg, 50 mg and 75 mg film-coated tablets:
Maltese: Revolade 12.5 mg, 25 mg, 50 mg u 75 mg pilloli miksija b'rita:
English: • increased levels of liver enzymes (aspartate aminotransferase (AST))
Maltese: • żieda fil-livelli ta' enzimi tal-fwied (aspartate aminotransferase (AST))
English: 9/l and absolute reticulocyte count was 24.3 x 10
Maltese: 9/l u l-għadd assolut tar-retikuloċiti kien ta' 24.3 x 10
English: PETIT2 (TRA115450) was a 2-part, double-blind and open-label, randomised, placebo-controlled study.
Maltese: PETIT2 (TRA115450) kien studju b'żewġ partijiet, double-blind u b'tikketta miftuħa, randomizzat, ikkontrollat bi plaċebo.
English: 50,000/µl to 150,000/µl
Maltese: 50,000/µl sa 150,000/µl
English: • increased levels of total protein
Maltese: • żieda fil-livelli ta' proteina totali
English: ≥50,000/µl to ≤100,000/µl
Maltese: ≥50,000/µl għal ≤100,000/µl
English: Thrombotic/thromboembolic complications
Maltese: Kumplikazzjonijiet trombotiċi/tromboemboliċi
English: PETIT (TRA108062) was a 3-part, staggered-cohort, open-label and double-blind, randomised, placebo-controlled study.
Maltese: PETIT (TRA108062) kien studju bi tliet partijiet, koorti mqassma, b'tikketta miftuħa u double-blind, randomizzat, ikkontrollat bi plaċebo.
English: • confusion, agitation
Maltese: • konfużjoni, aġitazzjoni
English: Patients are analysed according to the treatment received (total safety double-blind population, Revolade n=955 and placebo n=484).
Maltese: Il-pazjenti huma analizzati skont il-kura rċevuta (popolazzjoni double-blind ta' sigurtà totali, Revolade n=955 u plaċebo n=484).
English: Revolade...
Maltese: Ħu Revolade
English: HCV study population (in combination with anti-viral interferon and ribavirin therapy)
Maltese: Popolazzjoni tal-istudju ta' HCV (f'kombinazzjoni ma' terapija anti-virali b'interferon u ribavirin)
English: • stomach flu (gastroenteritis)
Maltese: • influwenza fl-istonku (gastroenterite)
English: Pharmacokinetics
Maltese: Farmakokinetika
English: Thrombotic/thromboembolic events (TEEs)
Maltese: Każijiet trombotiċi/tromboemboliċi (TEEs)
English: Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Maltese: Revolade 12.5 mg u 25 mg pilloli miksija b'rita fihom ukoll polysorbate 80 (E433).
English: • increase of liver enzymes (aspartate aminotransferase (AST))
Maltese: • żieda fl-enzimi tal-fwied (aspartate aminotransferase (AST))
English: Two phase III, randomised, double-blind, placebo-controlled studies RAISE (TRA102537) and TRA100773B and two open-label studies REPEAT (TRA108057) and EXTEND (TRA105325) evaluated the safety and efficacy of eltrombopag in adult patients with previously treated ITP.
Maltese: III, randomised, double-blind, kkontrollati mill-plaċebo, RAISE (TRA102537) u TRA100773B u żewġ studji open-label REPEAT (TRA108057) u EXTEND (TRA105325) stmaw is-sigurtà u l-effikaċja ta' eltrombopag f'pazjenti adulti b'ITP li kienet diġà kkurata qabel.
English: In vitro studies demonstrate that eltrombopag is an inhibitor of the OATP1B1 transporter and an inhibitor of the BCRP transporter and eltrombopag increased exposure of the OATP1B1 and BCRP substrate rosuvastatin in a clinical drug interaction study (see section 4.5).
Maltese: Studji in vitro juru li eltrombopag huwa impeditur tat-trasportatur OATP1B1 u impeditur tattrasportatur BCRP u eltrombopag żied l-esponiment għas-sustrat ta' OATP1B1 u BCRP, rosuvastatin, fi studju ta' interazzjoni klinika ta' mediċina (ara sezzjoni 4.5).
English: Discard suspension if not administered within 30 minutes after preparation.
Maltese: Armi s-suspensjoni jekk ma jingħatax fi żmien 30 minuta wara l-preparazzjoni.
English: Medicinal products used in the treatment of ITP in combination with eltrombopag in clinical studies included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Maltese: Prodotti mediċinali użati għall-kura ta' ITP flimkien ma' eltrombopag fi studji kliniċi kienu jinkludu kortikosterojdi, danazol, u/jew azathioprine, immunoglobulina minn ġol-vini (IVIG), u immunoglobulina anti-D.
English: At tolerated doses, no ocular opacities were observed (see above subsection ‘Safety pharmacology and repeat-dose toxicity').
Maltese: F'dożi ttollerati, ma kienet osservata l-ebda opaċità okulari (ara hawn fuq is-subsezzjoni “Farmakoloġija ta' sigurtà u tossiċità b'doża ripetuta”).
English: Statistically fewer eltrombopag patients required rescue treatment during the randomised period compared to placebo patients (19% [12/63] vs. 24% [7/29], p=0.032).
Maltese: Statistikament inqas pazjenti fuq eltrombopag kellhom bżonn trattament ta' salvataġġ matul ilperjodu randomised meta mqabbel ma' pazjenti fuq plaċebo (19% [12/63] vs. 24% [7/29], p=0.032).
English: Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin to 39 healthy adult subjects increased plasma rosuvastatin Cmax 103% (90% confidence interval [CI]: 82%, 126%) and AUC0- 55% (90% CI: 42%, 69%).
Maltese: Għoti ta' 75 mg eltrombopag darba kuljum għal 5 ijiem ma' doża waħda ta' 10 mg tas-sustrat ta' OATP1B1 u BCRP rosuvastatin lil 39 individwu adult f'saħħtu żied is-Cmax ta' rosuvastatin filplasma 103% (90% intervall ta' fiduċja [CI]: 82%, 126%) u l-AUC0- 55% (90% CI: 42%, 69%).
English: Common Palpitations
Maltese: Palpitazzjonijiet
English: Tablet coating Hypromellose (E464) Macrogol 400 (E1521) Polysorbate 80 (E433) Titanium dioxide (E171)
Maltese: Kisja tal-pillola Hypromellose (E464) Macrogol 400 (E1521) Polysorbate 80 (E433) Titanium dioxide (E171)
English: Effects of other medicinal products on eltrombopag
Maltese: Effetti ta' prodotti mediċinali oħra fuq eltrombopag
English: • depression, anxiety, sleep problems, nervousness
Maltese: • dipressjoni, ansjetà, problemi biex torqod, nervożiżmu
English: Eltrombopag was administered to 302 ITP patients in the open-label extension study EXTEND (TRA105325), 218 patients completed 1 year, 180 completed 2 years, 107 completed 3 years, 75 completed 4 years, 34 completed 5 years and 18 completed 6 years.
Maltese: Eltrombopag ingħata lil 302 pazjent b'ITP fl-istudju ta' estensjoni open label EXTEND (TRA105325), 218 pazjent temmew sena, 180 temmew sentejn, 107 temmew tliet snin, 75 temmew erba' snin, 34 temmew ħames snin u 18 temmew sitt snin ta' kura.
English: Administration of a single dose of eltrombopag 75 mg with a polyvalent cation-containing antacid (1524 mg aluminium hydroxide and 1425 mg magnesium carbonate) decreased plasma eltrombopag AUC0- by 70% (90% CI: 64%, 76%) and Cmax by 70% (90% CI: 62%, 76%).
Maltese: Għoti ta' doża waħda ta' eltrombopag 75 mg flimkien ma' antaċidu li fih katjoni polivalenti (1524 mg aluminium hydroxide u 1425 mg magnesium carbonate) naqqas l-AUC0- ta' eltrombopag fil-plażma b'70% (90% CI: 64%, 76%) u s-Cmax b'70% (90% CI: 62%, 76%).
English: Approximately 21% of an eltrombopag dose could undergo oxidative metabolism.
Maltese: Madwar 21% minn doża ta' eltrombopag jista' jsirilha metaboliżmu ossidattiv.
English: QT/QTc prolongation
Maltese: Titwil tal-QT/QTc
English: • 75 mg dose - 3 sachets
Maltese: • Doża ta' 75 mg- 3 qratas
English: Pack size of 30 sachets.
Maltese: Daqs tal-pakkett ta' 30 qartas.
English: >150,000/µl to 250,000/µl
Maltese: >150,000/µl sa 250,000/µl
English: Eltrombopag Placebo Eltrombopag Placebo Eltrombopag Placebo
Maltese: Plaċebo Eltrombop ag
English: Fatigue, pyrexia, chills
Maltese: Għeja, piressija, dehxiet
English: Total bilirubin >1.5 x ULN occurred in 14% of patients.
Maltese: Bilirubin totali >1.5 x ULN seħħ f'14% tal-pazjenti.
English: Increase of alanine aminotransferase and aspartate aminotransferase may occur simultaneously, although at a lower frequency.
Maltese: Żieda fl-alanine aminotransferase u aspartate aminotransferase tista' sseħħ simultanjament, għalkemm fi frekwenza aktar baxxa.
English: • decreased levels of potassium
Maltese: • tnaqqis fil-livelli ta' potassju
English: Overall, total bilirubin ≥1.5 x ULN was reported in 76% and 50% of the eltrombopag and placebo groups, respectively.
Maltese: B'kollox, ġiet irrappurtata bilirubin totali ta' ≥1.5 x ULN f'76% u 50% tal-gruppi ta' eltrombopag u plaċebo, rispettivament.
English: Eltrombopag does not inhibit or induce CYP enzymes based on in vitro and in vivo data (see section 4.5).
Maltese: Eltrombopag ma jimpedixxix jew jinduċi enzimi CYP skont dejta in vitro u in vivo (ara sezzjoni 4.5).
English: During treatment with eltrombopag 59% (23/39) became platelet transfusion independent (28 days without platelet transfusion) and 27% (10/37) became RBC transfusion independent (56 days without RBC transfusion).
Maltese: Matul it-trattament b'eltrombopag 59% (23/39) saru indipendenti għal trasfużjoni ta' plejtlits (28 jum mingħajr trasfużjoni ta' plejtlits) u 27% (10/37) saru indipendenti għal trasfużjoni ta' RBC (56 jum mingħajr trasfużjoni ta' RBC).
English: Of the 714 patients, 642 were with mild hepatic impairment, 67 with moderate hepatic impairment, and 2 with severe hepatic impairment.
Maltese: Mis-714-il pazjent, 642 kienu b'indeboliment epatiku ħafif, 67 b'indeboliment epatiku moderat, u 2 b'indeboliment epatiku sever.
English: Take Revolade
Maltese: Tiħux Revolade
English: Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans.
Maltese: Lgħoti ta' 75 mg eltrombopag darba kuljum għal 7 ijiem lil 24 raġel f'saħħtu ma impeddixxiex jew induċa l-metaboliżmu tas-substrati ta' stħarriġ għal 1A2 (kafeina), 2C19 (omeprazole), 2C9 (flurbiprofen), jew 3A4 (midazolam) fil-bnedmin.
English: • irritation and inflammation (swelling) of the sinuses
Maltese: • irritazzjoni u infjammazzjoni (nefħa) tas-sinuses
English: ENABLE 1 (TPL103922 n=716) and ENABLE 2 (TPL108390 n=805) were randomised, double-blind, placebo-controlled, multicentre studies to assess the efficacy and safety of Revolade in thrombocytopenic patients with HCV infection who were otherwise eligible to initiate antiviral therapy.
Maltese: ENABLE 1 (TPL103922 n=716) u ENABLE 2 (TPL108390 n=805) kienu studji randomizzat, double-blind, ikkontrollati bi plaċebo, multiċentriċi biex jivvalutaw l-effikaċja u s-sigurtà ta' Revolade f'pazjenti tromboċitopeniċi b'infezzjoni HCV li nkella kienu eliġibbli biex jibdew terapija antivirali.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Maltese: Il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa għall-mediċina hija bbażata fuq il-konvenzjoni li ġejja (CIOMS III): komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); mhux magħruf (ma jistax jiġi stmat mid-data disponibbli).
English: Absorbed eltrombopag is extensively metabolised.
Maltese: Eltrombopag assorbit huwa mmetabolizzat b'mod estensiv.
English: • 50 mg dose - 2 sachets
Maltese: • Doża ta' 50 mg- 2 qratas
English: You will need regular tests
Maltese: Inti se jkollok bżonn testijiet regolari
English: Common Blood creatine phosphokinase increased
Maltese: Żieda tal-kreatina fosfokinasi fid-demm
English: In the HCV studies the safety population consisted of all randomised patients who received double-blind study medicinal product during Part 2 of ENABLE 1 (Revolade treatment n=450, placebo treatment n=232) and ENABLE 2 (Revolade treatment n=506, placebo treatment n=253).
Maltese: Fl-istudji ta' HCV, il-popolazzjoni ta' sigurtà kienet tikkonsisti mill-pazjenti kollha randomizzati li ngħataw prodott mediċinali ta' studju double-blind waqt il-Parti 2 ta' ENABLE 1 (kura b'Revolade n=450, kura bi plaċebo n=232) u ENABLE 2 (kura b'Revolade n=506, kura bi plaċebo n=253).
English: The influence of Asian ethnicity (such as Japanese, Chinese, Taiwanese and Korean) on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 111 healthy adults (31 Asians) and 88 patients with ITP (18 Asians).
Maltese: L-influwenza ta' dixxendenza Asjatika (jiġifieri Ġappuniżi, Ċiniżi, mit-Tajwan, u Koreani) fuq ilfarmakokinetika ta' eltrombopag kienet stmata bl-użu ta' analiżi ta' farmakokinetika ta' popolazzjoni f'111-il adult f'saħħtu (31 Asjatiku) u 88 pazjent b'ITP (18-il Asjatiku).
English: • decreased vision
Maltese: • tnaqqis fil-vista
English: Paediatric Population (aged 1 to 17 years)
Maltese: Popolazzjoni pedjatrika (età minn sena sa 17-il sena)
English: A decrease in eltrombopag exposure was observed with co-administration of 200 mg and 600 mg ciclosporin (a BCRP inhibitor).
Maltese: Tnaqqis fl-espożizzjoni tal-eltrombopag deher meta ngħata flimkien ma' 200 mg u 600 mg ciclosporin (inibitur ta' BCRP).
English: Table 9 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in patients with chronic HCV
Maltese: Tabella 9 Medja ġeometrika (95% CI) tal-parametri farmakokinetiċi fi stat fiss ta' eltrombopag fil-plasma f'pazjenti b'HCV kronika
English: • increased levels of alkaline phosphatase
Maltese: • żieda fil-livelli ta' alkaline phosphatase