FrancophonIA/ELRC3.0 huggingface dataset:
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily).
Maltese: Huwa rakkomandat tnaqqis fid-doża meta axitinib jiġi amministrat lil pazjenti b'indeboliment epatiku moderat (Child-Pugh klassi B) (eż. id-doża talbidu għandha titnaqqas minn 5 mg darbtejn kuljum għal 2 mg darbtejn kuljum).
English: CI = Confidence interval, HR = Hazard ratio (axitinib/sorafenib); ITT: Intent-to-treat; NE: not estimable; NS:
Maltese: f (1.43-3.99) CI = Intervall ta' Kunfidenza, HR = Proporzjon ta' periklu (axitinib/sorafenib);
English: Inlyta 7 mg: each tablet contains 7 mg axitinib
Maltese: Inlyta 7 mg: kull pillola fiha 7 mg axitinib
English: Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Maltese: Emorraġija Fi studji kliniċi b'axitinib, ġew irrapportati avvenimenti emorraġiċi (ara sezzjoni 4.8).
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, 34% of patients treated with axitinib were ≥ 65 years of age.
Maltese: Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, 34% tal-pazjenti ttrattati b'axitinib kellhom ≥ 65 sena.
English: In a clinical dose-finding study, concurrent elevations of ALT (12 times the ULN) and bilirubin (2.3 times the ULN), considered to be drug-related hepatotoxicity, were observed in 1 patient who received axitinib at a starting dose of 20 mg twice daily (4 times the recommended starting dose).
Maltese: Fi studju kliniku ta' sejbien tad-doża, żidiet simultanji fl-ALT (12-il darba aktar mill-ULN) u filbilirubin (2.3 darbiet aktar mill-ULN), meqjusa li kienu epatotossiċità relatata mal-mediċina, ġew osservati f'pazjent wieħed li rċieva axitinib b'doża tal-bidu ta' 20 mg darbtejn kuljum (4 darbiet aktar mid-doża tal-bidu rakkomandata).
English: • If you have thyroid gland problems.
Maltese: • Jekk għandek problemi fil-glandola tat-tirojde.
English: The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat l-obbligu li jiġu sottomessi r-riżultati tal-istudji b'axitinib fis-subsetti kollha tal-popolazzjoni pedjatrika għat-trattament ta' karċinoma tal-kliewi u talpelvis renali (esklużi nefroblastoma, nefroblastomatożi, sarkoma taċ-ċelloli ċari, nefroma mesoblastika, karċinoma medullari renali u tumur rabdojde tal-kliewi) (ara sezzjoni 4.2 għal tagħrif dwar l-użu pedjatriku).
English: Venous embolic and thrombotic events
Maltese: Avvenimenti emboliċi u trombotiċi fil-vini
English: Grade 4 arterial embolic and thrombotic events were reported in 1.3% of patients.
Maltese: Avvenimenti emboliċi u trombotiċi arterjali ta' Grad 4 ġew irrappurtati f'1.3% tal-pazjenti.
English: Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Maltese: Inlyta 5 mg jiġi fi fliexken ta' 60 pillola u pakketti b'folji ta' 14il pillola.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions were reported in 4.7% of patients receiving axitinib, including myocardial infarction (1.4%), transient ischemic attack (0.8%) and cerebrovascular accident (0.6%).
Maltese: Avvenimenti emboliċi u trombotiċi arterjali (ara sezzjoni 4.4) Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, reazzjonijiet avversi trombotiċi u emboliċi fl-arterji kienu rrappurtati f'4.7% tal-pazjenti li rċivew axitinib, inkluż infart mijokardijaku (1.4%), attakk iskemiku temporanju (0.8%) u inċident ċerebrovaskulari (0.6%).
English: Inlyta is a medicine containing the active substance axitinib.
Maltese: Inlyta hija mediċina li fiha s-sustanza attiva axitinib.
English: • If you have liver problems.
Maltese: • Jekk tbati minn problemi ta' fsada.
English: Other medicines and Inlyta
Maltese: Mediċini oħra u Inlyta
English: The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin (see section 4.8).
Maltese: L-aktar reazzjonijiet avversi relatati mal-fwied irrapportati b'mod komuni kienu jinkludu żidiet fl-alanine aminotransferase (ALT), aspartate aminotransferase (AST), u bilirubin tad-demm (ara sezzjoni 4.8).
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza ta' galattożju, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glukożju-galattożju ma għandhomx jieħdu dan il-prodott mediċinali.
English: During routine laboratory assessments, in patients who had TSH < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Maltese: Matul valutazzjonijiet ta' rutina fil-laboratorju, f'pazjenti li kellhom TSH < 5 μU/mL qabel it-trattament, żidiet ta' TSH għal ≥10 μU/mL seħħew fi 32.2% tal-pazjenti li rċivew axitinib.
English: In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function.
Maltese: Fi studji kliniċi b'axitinib, l-espożizzjoni sistemika għal axitinib kienet bejn wieħed u ieħor darbtejn ogħla f'individwi b'indeboliment epatiku moderat (Child-Pugh klassi B) meta mqabbla ma' individwi b'funzjoni epatika normali.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.9% of patients receiving axitinib, including pulmonary embolism (2.2%), retinal vein occlusion/thrombosis (0.6%) and deep vein thrombosis (0.6%).
Maltese: Avvenimenti emboliċi u trombotiċi fil-vini (ara sezzjoni 4.4) Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, reazzjonijiet emboliċi u trombotiċi avversi fil-vini ġew irrapportati f'3.9% tal-pazjenti li rċivew axitinib, inklużi emboliżmu pulmonari (2.2%), sadd/trombożi tal-vina retinali (0.6%) u trombożi tal-vini fondi (0.6%).
English: c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
Maltese: Valur-p unilaterali minn test tal-log-rank tat-trattament stratifikat skont l-istat tal-prestazzjoni ECOG u terapija preċedenti.
English: In clinical studies with axitinib, venous embolic and thrombotic events (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis) were reported (see section 4.8).
Maltese: Fl-istudji kliniċi b'axitinib, ġew irrapportati avvenimenti emboliċi u trombotiċi fil-vini (inklużi emboliżmu pulmonari, trombożi tal-vini fondi, u sadd/trombożi tal-vina retinali) (ara sezzjoni 4.8).
English: k Gastrointestinal perforation and fistula includes the following preferred terms: abdominal abscess, anal abscess, anal fistula, fistula, gastrointestinal anastomotic leak, gastrointestinal perforation, large intestine perforation, oesophagobronchial fistula and peritonitis.
Maltese: Perforazzjoni gastrointestinali u fistula jinkludu t-termini ppreferuti li ġejjin: axxess addominali, axxess anali, fistula anali, fistula, tnixxija anastomotika gastrointestinali, perforazzjoni gastrointestinali, perforazzjoni talmusrana l-kbira, fistula esofagobronkjali u peritonite.
English: Table 1 presents adverse reactions reported in a pooled dataset of 672 patients who received axitinib in clinical studies for the treatment of patients with RCC (see section 5.1).
Maltese: It-Tabella 1 tippreżenta r-reazzjonijiet avversi rrapportati f'sett miġbur ta' dejta ta' 672 pazjent li rċivew axitinib fi studji kliniċi għat-trattament ta' pazjenti b'RCC (ara sezzjoni 5.1).
English: Inlyta 1 mg: each tablet contains 1 mg axitinib
Maltese: Inlyta 1 mg: kull pillola fiha 1 mg axitinib
English: Inlyta may increase the risk of developing heart failure events.
Maltese: Inlyta jista' jżid ir-riskju ta' żvilupp ta' avvenimenti ta' insuffiċjenza tal-qalb.
English: Do not take this medicine with grapefruit or grapefruit juice, as it may increase the chance of side effects.
Maltese: Tiħux din il-mediċina mal-grejprut jew mal-meraq tal-grejpfrut, peress li jistgħu jżidu l-probabilità ta' effetti sekondarji.
English: Population pharmacokinetic analyses in patients with advanced cancer (including advanced RCC) and healthy volunteers indicate that there are no clinically relevant effects of age, gender, body weight, race, renal function, UGT1A1 genotype, or CYP2C19 genotype.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'kanċer avvanzat (inkluż RCC avvanzat) u voluntiera b'saħħithom indikaw li m'hemmx effetti klinikament relevanti tal-età, is-sess tal-persuna, il-piż, ir-razza, il-funzjoni renali, il-ġenotip UGT1A1, jew il-ġenotip CYP2C19.
English: A significant increase in polyploidy was observed in vitro at concentrations > 0.22 µg/mL, and an elevation in micronucleated polychromatic erythrocytes was observed in vivo with No Observed Effect Level (NOEL) 69-fold the expected human exposure.
Maltese: In vitro, ġiet osservata żieda sinifikanti fil-poliplojdi f'konċentrazzjonijiet > 0.22 µg/mL, u in vivo, ġiet osservata żieda fl-eritroċiti polikromatiċi mikronukleati bil-Livell tal-Ebda Effett Avvers
English: Grade > 3 haemorrhagic adverse reactions were reported in 3.1% of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower gastrointestinal haemorrhage and haemoptysis).
Maltese: Reazzjonijiet avversi emorraġiċi ta' Grad ≥ 3 ġew irrapportati f'3.1% tal-pazjenti li rċivew axitinib (inklużi emorraġija ċerebrali, emorraġija gastrika, emorraġija mill-parti t'isfel tas-sistema gastrointestinali u emoptisi).
English: In monotherapy studies with axitinib (N = 672) for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported in 1.8% patients receiving axitinib.
Maltese: Fi studji ta' monoterapija b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, avvenimenti ta' insuffiċjenza tal-qalb (inkluż insuffiċjenza tal-qalb, insuffiċjenza konġestiva tal-qalb, insuffiċjenza kardjopulmonari, disfunzjoni tal-ventrikolu tax-xellug, tnaqqis fil-frazzjoni tat-tfigħ 'il barra, u insuffiċjenza tal-ventrikolu tal-lemin) ġew irrapportati f'1.8% ta' pazjenti li rċivew axitinib.
English: Grade 3 arterial embolic and thrombotic events were reported in 1.2% of patients.
Maltese: Avvenimenti emboliċi u trombotiċi arterjali ta' Grad 3 ġew irrappurtati f'1.2% tal-pazjenti.
English: Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Maltese: Inlyta hu indikat għat-trattament ta' pazjenti adulti b'karċinoma avvanzata taċ-ċellola renali (RCC) wara li jkun falla trattament preċedenti b'sunitinib jew ċitokina.
English: • Shortness of breath, cough, hoarseness
Maltese: • Qtugħ ta' nifs, sogħla, ħanqa
English: Very common Headache Dysgeusia
Maltese: Komuni ħafna Dispneja Sogħla
English: Grade 3 venous embolic and thrombotic events were reported in 0.9% of patients.
Maltese: Avvenimenti emboliċi u trombotiċi fil-vini ta' Grad 3 ġew irrappurtati f'0.9% tal-pazjenti.
English: • Bleeding.
Maltese: • Fsada.
English: EU/1/12/777/011 56 tablets
Maltese: EU/1/12/777/010 28 pillola EU/1/12/777/011 56 pillola
English: Median PFS a,b in months (95% CI)
Maltese: PFS medjan a,b f'xhur
English: Vascular disorders Very common Hypertensiong Haemorrhagec,d,h
Maltese: Komuni ħafna Pressjoni għolja Emorraġija ċ,d,h
English: Gastrointestinal perforation and fistulac,k
Maltese: Glossodinja Perforazzjoni gastro-intestinali u fistula ċ,k
English: Each film-coated tablet contains 58.8 mg of lactose monohydrate.
Maltese: Inlyta 5 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 58.8 mg lactose monohydrate.
English: Glossodynia
Maltese: Nawsja
English: In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
Maltese: Studji in vitro indikaw li axitinib għandu potenzjal li jinibixxi CYP1A2.
English: Grade 3/4 cardiac failure events were reported in 1.0% patients and fatal cardiac failure events were reported in 0.3% patients receiving axitinib.
Maltese: Avvenimenti ta' insuffiċjenza tal-qalb ta' Grad 3/4 ġew irrapportati f'1.0% ta' pazjenti u avvenimenti ta' insuffiċjenza fatali tal-qalb ġew irrapportati f'0.3% ta' pazjenti li rċivew axitinib.
English: • Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests)
Maltese: • Bidliet fil-livelli ta' sustanzi kimiċi/enzimi differenti fid-demm (dawn jistgħu jidhru fit-testijiet tad-demm tiegħek)
English: Uncommon Neutropaenia Leukopaenia
Maltese: Komuni ħafna Dijarea Rimettar
English: • Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Maltese: • Emboli fil-vini u l-arterji tiegħek (tipi ta' vini tad-demm), inklużi puplesija, attakk talqalb, emboliżmu jew trombożi.
English: Major toxicity findings in mice and dogs following repeated dosing for up to 9 months were the gastrointestinal, haematopoietic, reproductive, skeletal and dental systems, with No Observed Adverse Effect Levels (NOAEL) approximately equivalent to or below expected human exposure at the recommended clinical starting dose (based on AUC levels).
Maltese: Sejbiet importanti tal-effett tossiku fil-ġrieden u l-klieb wara dożaġġ ripetut sa 9 xhur kienu s-sistema gastro-intestinali, ematopojetika, riproduttiva, skeletali u dentali, bil-Livelli ta' Ebda Effett Avvers Osservat (NOAEL) li kienu bejn wieħed u ieħor ekwivalenti għal jew inqas mill-espożizzjoni umana fid-doża klinika tal-bidu rakkomandata (fuq il-bażi tal-livelli ta' AUC).
English: Each blister pack contains 28 tablets or 56 tablets.
Maltese: Kull pakkett b'folji fih 28 pillola jew 56 pillola.
English: Inlyta 3 mg: each tablet contains 3 mg axitinib
Maltese: Inlyta 3 mg: kull pillola fiha 3 mg axitinib
English: A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm. g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
Maltese: Il-proporzjon ta' riskju huwa użat għall-ORR. Proprozjon ta' riskju ta' > 1 indika probabbiltà akbar ta' rispons fil-grupp li ħa axitinib; proporzjon ta' riskju ta' < 1 indika probabbiltà akbar ta' rispons fil-grupp li ħa sorafenib.
English: Oropharyngeal pain
Maltese: Aġġustamenti fid-doża
English: Grade 4 venous embolic and thrombotic events were reported in 1.2% of patients.
Maltese: Avvenimenti emboliċi u trombotiċi fil-vini ta' Grad 4 ġew irrappurtati f'1.2% tal-pazjenti.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.4% of patients receiving axitinib.
Maltese: Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, poliċitemija ġiet irrapportata f'1.4% tal-pazjenti li rċivew axitinib.
English: Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1% of patients receiving axitinib.
Maltese: Reazzjonijiet emboliċi u trombotiċi avversi fil-vini tal-Grad 3/4 ġew irrapportati f'3.1% tal-pazjenti li rċivew axitinib.
English: Fatal arterial embolic and thrombotic events were reported in 0.3% patients receiving axitinib.
Maltese: Avvenimenti emboliċi u trombotiċi arterjali fatali ġew irrappurtati f'0.3% tal-pazjenti li kienu qed jirċievu axitinib.
English: Inlyta 5 mg: each tablet contains 5 mg axitinib
Maltese: Inlyta 5 mg: kull pillola fiha 5 mg axitinib
English: Grade 3/4 arterial embolic and thrombotic adverse reactions were reported in 3.3% of patients receiving axitinib.
Maltese: Reazzjonijiet emboliċi u trombotiċi avversi fl-arterji tal-Grad 3/4 ġew irrapportati f'3.3% tal-pazjenti li rċivew axitinib.
English: Inlyta 7 mg film-coated tablets EU/1/12/777/010
Maltese: Inlyta 7 mg pilloli miksijin b'rita EU/1/12/777/010
English: Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Maltese: Emboliżmu pulmonari fatali ġie rrapportat f'pazjent wieħed (0.3%) li rċieva axitinib.
English: Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other.
Maltese: Inlyta 7 mg pilloli miksijin b'rita huma ħomor, b'forma ta' djamant u fuqhom hemm imnaqqax “Pfizer” fuq naħa u “7 XNB” fuq in-naħa l-oħra.
English: Polycythaemia (see Elevation of haemoglobin or haematocrit in section 4.4)
Maltese: Poliċitemija (ara Żieda fil-livelli ta' emoglobina jew ta' ematokrit f'sezzjoni 4.4)
English: The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Eastern Cooperative Oncology Group (ECOG) performance status, geographic region, and prior treatment.
Maltese: Il-karatteristiċi demografiċi u tal-mard fil-linja bażi kienu simili bejn il-gruppi li ħadu axitinib u dawk li ħadu sorafenib fir-rigward tal-età, is-sess tal-persuna, ir-razza, l-istatus ta' prestazzjoni tal-Eastern Cooperative Oncology Group (ECOG), ir-reġjun ġeografiku, u t-trattament minn qabel.
English: • Use a reliable method of contraception while you are taking Inlyta and up to 1 week after the last dose of this medicine, to prevent pregnancy.
Maltese: • Uża metodu ta' kontraċezzjoni affidabbli waqt li tieħu Inlyta u sa ġimgħa wara l-aħħar doża ta' din il-mediċina, sabiex tevita t-tqala.
English: Inlyta 5 mg film-coated tablets EU/1/12/777/004
Maltese: Inlyta 5 mg pilloli miksijin b'rita EU/1/12/777/004
English: The magnitude of median PFS effect was different in the subgroups by prior therapy.
Maltese: Id-daqs tal-effett tal-PFS medjan kien differenti fis-sottogruppi li ħadu terapija preċedenti.
English: Inlyta contains lactose (milk sugar)
Maltese: Inlyta fih il-lactose (zokkor tal-ħalib)
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients.
Maltese: Fi studju kliniku kkontrollat b'axitinib għat-trattament ta' pazjenti b'RCC, l-ipotirojdiżmu ġie rrapportat fi 20.9% tal-pazjenti u l-ipertirojdiżmu ġie rrapportat f'1.1% tal-pazjenti.
English: Fatal venous embolic and thrombotic events were reported 0.1% patients receiving axitinib.
Maltese: Avvenimenti emboliċi u trombotiċi fil-vini fatali ġew irrappurtati f'0.1% tal-pazjenti li kienu qed jirċievu axitinib.
English: i
Maltese: JIS
English: Elderly, gender, and race
Maltese: Anzjani, sess tal-persuna, u razza
English: Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Maltese: Inlyta 7 mg jiġi fi fliexken ta' 60 pillola u pakketti b'folji ta' 14- il pillola.
English: How to take Inlyta
Maltese: Tiħux Inlyta:
English: EU/1/12/777/008 56 tablets
Maltese: EU/1/12/777/007 28 pillola EU/1/12/777/008 56 pillola
English: Uncommon Posterior reversible encephalopathy syndromee
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli (PRES)
English: Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Maltese: Inlyta 5 mg pilloli miksijin b'rita Pillola triangulari ħamra miksija b'rita b'“Pfizer” imnaqqxa fuq naħa u “5
English: The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.4: cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of haemoglobin or haematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, PRES, proteinuria, and elevation of liver enzymes.
Maltese: avvenimenti tromboemboliċi arterjali, avvenimenti tromboemboliċi fil-vini, żieda fil-livelli ta' emoglobina jew ematokrit, emorraġija, perforazzjoni gastrointestinali u formazzjoni ta' fistuli, kumplikazzjonijiet fil-fejqan tal-feriti, PRES, proteinurja, u żieda fl-enzimi tal-fwied.
English: Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Maltese: Figura 3. Il-kurva Kaplan-Meier ta' sopravivenza ħielsa minn progressjoni skont valutazzjoni indipendenti għas-sottogrupp li ħa cytokine qabel
English: In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8.
Maltese: Studji in vitro indikaw ukoll li axitinib għandu l-potenzjal li jinibixxi CYP2C8.
English: In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Maltese: Studji in vitro f'epatoċiti umani indikaw ukoll li axitinib ma jinduċix CYP1A1, CYP1A2, jew CYP3A4/5.
English: Grade 4 haemorrhagic adverse reactions were reported in 1% of patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
Maltese: Reazzjonijiet avversi emorraġiċi ta' Grad 4 ġew irrappurtati f'1% tal-pazjenti u emorraġija fatali ġiet irrappurtata f'0.4% tal-pazjenti li kienu qed jirċievu axitinib.
English: Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy (see section 4.4).
Maltese: Il-kontroll ta' ċerti reazzjonijiet avversi jista' jkun jeħtieġ waqfien temporanju jew permanenti tat-terapija b'axitinib (ara sezzjoni 4.4).
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, arterial embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, avvenimenti emboliċi u trombotiċi arterjali ġew irrappurtati fi 2.8% tal-pazjenti li kienu qed jirċievu axitinib.
English: The decision to resume axitinib therapy after surgery should be based on clinical judgment of adequate wound healing.
Maltese: Id-deċiżjoni li titkompla t-terapija b'axitinib wara l-kirurġija għandha tkun ibbażata fuq ġudizzju klinika ta' fejqan adegwat tal-feriti.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, haemorrhagic events were reported in 25.7% of patients receiving axitinib.
Maltese: Fi studji kliniċi miġbura b'axitinib (N = 672) għat-trattament ta' pazjenti b'RCC, avvenimenti emorraġiċi ġew irrappurtati f'25.7% tal-pazjenti li kienu qed jirċievu axitinib.
English: The safety and efficacy of axitinib were evaluated in a randomised, open-label, multicenter Phase 3 study.
Maltese: Is-sigurtà u l-effikaċja ta' axitinib ġew evalwati fi studju ta' fażi 3 multiċentri, open-label, fejn lindividwi intgħażlu b'mod każwali.
English: How to store Inlyta
Maltese: X'fih Inlyta
English: Inlyta 1 mg film-coated tablets EU/1/12/777/001
Maltese: Inlyta 1 mg pilloli miksijin b'rita EU/1/12/777/001
English: In a controlled clinical study with axitinib (N = 359) for the treatment of patients with RCC, cardiac failure events were reported in 1.7 % patients receiving axitinib, including cardiac failure (0.6%), cardiopulmonary failure (0.6%), left ventricular dysfunction (0.3%), and right ventricular failure
Maltese: Avvenimenti ta' insuffiċjenza tal-qalb (ara sezzjoni 4.4) Fi studju kliniku kkontrollat b'axitinib (N = 359) għat-trattament ta' pazjenti b'RCC, avvenimenti ta' insuffiċjenza tal-qalb ġew irrapportati f'1.7% tal-pazjenti li rċivew axitinib, inkluż insuffiċjenza talqalb (0.6%), insuffiċjenza kardjopulmonari (0.6%), disfunzjoni tal-ventrikolu tax-xellug (0.3%), u insuffiċjenza tal-ventrikolu tal-lemin (0.3%).