FrancophonIA/ELRC3.0 huggingface dataset:
English: In a male fertility study in rats, testicular morphology was affected at 0.5 mg/kg and above, and sperm motility, sperm head count, and plasma testosterone levels were diminished at 5 mg/kg which caused a reduction in male fertility.
Maltese: Fi studju ta' fertilità tar-raġel fil-firien, il-morfoloġija tat-testikoli kienet affettwata f'doża ta' 0.5 mg/kg u aktar, u l-motilità tal-isperma, l-għadd ta' sperma, u l-livelli ta' testosteron fil-plażma kienu mnaqqsa f'doża ta' 5 mg/kg li kkawżat tnaqqis fil-fertilità tar-raġel.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis, candidiasis or PJP/PCP and viral infections including reactivation of hepatitis B virus, have been described in patients taking Afinitor.
Maltese: Infezzjonijiet lokalizzati u sistemiċi, inkluż pulmonite, u infezzjonijiet oħrajn bil-batteriji, infezzjonijiet invażivi bil-fungu bħal asperġillożi, kandidjasi jew PJP/PCP u infezzjonijiet bil-viruses, inklużi attivazzjoni mill-ġdid tal-virus tal-epatite B, kienu deskritti f'pazjenti li kienu qed jieħdu Afinitor.
English: Six main metabolites of everolimus have been detected in human blood, including three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus.
Maltese: Sitt metaboliti ewlenin ta' everolimus kienu osservati fid-demm tal-bniedem, inklużi tliet metaboliti monoidroksilati, żewġ prodotti idrolitiċi ċirku miftuħ u konjugat phosphatidylcholine ta' everolimus.
English: Afinitor 5 mg tablets everolimus
Maltese: Afinitor 5 mg pilloli everolimus
English: The most common adverse reactions (incidence ≥1/10) from the pooled safety data were (in decreasing order): stomatitis, rash, fatigue, diarrhoea, infections, nausea, decreased appetite, anaemia, dysgeusia, pneumonitis, oedema peripheral, hyperglycaemia, asthenia, pruritus, weight decreased, hypercholesterolaemia, epistaxis, cough and headache.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥1/10) mid-dejta miġbura dwar is-sigurtà kienu (f'ordni li tibda bl-aktar komuni): stomatite, raxx, għeja, dijarrea, infezzjonijiet, dardir, nuqqas ta' aptit, anemija, disġewżja, pulmonite, edema periferali, ipergliċemija, astenija, ħakk tal-ġilda, tnaqqis fil-piż, ħakk, astenja, edima periferali, iperkolesterolemija, epistassi, sogħla u uġigħ ta' ras.
English: In total, 416 patients were randomised 2:1 to receive Afinitor (n=277) or placebo (n=139).
Maltese: B'kollox, 416-il pazjent inzertaw ingħażlu 2:1 biex jingħataw Afinitor (n=277) jew plaċebo (n=139).
English: Co-administration of everolimus and depot octreotide increased octreotide Cmin with a geometric mean ratio (everolimus/placebo) of 1.47.
Maltese: L-għoti flimkien ta' everolimus u depot octreotide żied is- Cmin ta' octreotid bi proporzjon medja ġeometrika (everolimus/plaċebo) ta' 1.47%.
English: The overall safety profile in this study was consistent with that established for everolimus in the oncology and tuberous sclerosis complex (TSC) settings, with the exception of a slightly increased frequency of oral candidiasis which was reported in 2.2% (n=2/92) of patients.
Maltese: Il-profil ta' sigurtà sħiħ f'dan l-istudju kien konsistenti ma' dak stabbilit għal everolimus f'ambjent ta' onkoloġija u tal-kumpless tuberuż tal-isklerożi (TSC - tuberous sclerosis complex), ħlief għal żieda żgħira filfrekwenza ta' kandidijasi orali li kienet irrappurtati fi 2.2% (n=2/92) tal-pazjenti.
English: EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Maltese: EU/1/09/538/009 30 pillola EU/1/09/538/010 90 pillola
English: Grade 2 Consider interruption of therapy until symptoms improve to Grade 1.
Maltese: Grad 2 Ikkunsidra t-twaqqif tat-terapija sa ma jitjiebu s-sintomi għal  Grad 1.
English: • Menstruation disorders such as absence of periods (amenorrhoea)
Maltese: • Disturbi fil-menstrwazzjoni bħal nuqqas ta' pirjid (amenorrea)
English: Posology For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
Maltese: Pożoloġija Għal skeda ta' dożi differenti, Afinitor huwa disponibbli bħala pilloli ta' 2.5 mg, 5 mg u 10 mg.
English: The major target organs were male and female reproductive systems (testicular tubular degeneration, reduced sperm content in epididymides and uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats and mice; pancreas (degranulation and vacuolation of exocrine cells in monkeys and minipigs, respectively, and degeneration of islet cells in monkeys), and eyes (lenticular anterior suture line opacities) in rats only.
Maltese: L-organi fil-mira ewlenija kienu s-sistemi riproduttivi tal-irġiel u tan-nisa (deġenerazzjoni tubulari tat-testikoli, tnaqqis fl-ammont tal-isperma fl-epididymis u atrofija tal-utru) f'diversi speċi; il-pulmuni (żieda fil-makrofaġi tal-alveoli) fil-ġrieden u l-firien; il-frixa (degranulazzjoni u vakulazzjoni ta' ċelluli tal-exocrine f'xadini u ħnieżer ta' razza żgħira), rispettivament, u deġenerazzjoni ta' ċelluli islets f'xadini), u l-għajnejn (opaċitajiet tal-lenti fil-linja ta' sutura anterjuri) fil-firien biss.
English: If symptoms are moderate (Grade 2) or severe (Grade 3) the use of corticosteroids may be indicated until clinical symptoms resolve.
Maltese: Jekk is-sintomi jkunu moderati (Grad2 ) jew gravi (Grad 3) l-użu ta' kortikosterojdi jista' jkun indikat sakemm jirrisolvu s-sintomi kliniċi.
English: Elevations of serum creatinine, usually mild, and proteinuria have been reported (see section 4.8).
Maltese: Żidiet, ġeneralment ħfief, fil-livelli tal-krejatinina fis-serum, u tal-proteinuria kienu rrappurtati (ara sezzjoni 4.8).
English: Uncommon Flushing, deep vein thrombosis Respiratory, thoracic and mediastinal disorders Very common Pneumonitis c, epistaxis, cough
Maltese: Mhux komuni Fawra, trombożi tal-vini mhux superfiċjali Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna Pulmonite c, epistassi, sogħla
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment.
Maltese: Nisa f'età li jista' jkollhom it-tfal/Kontraċezzjoni fl-irgiel u n-nisa Nisa li jistgħu joħorġu tqal għandhom jużaw metodu mill-aktar effettiv ta' kontraċezzjoni (eż. orali, injezzjoni, metodu ppjantat ta' kontroll tat-twelid ormonali li ma fihx estroġenu, kontraċettivi li fihom il-proġesteronu, isterektomija, irbit tat-tubi, astinenza totali, metodi ta' barriera, apparat fl-utru [IUD], u/jew sterilizzazzjoni tal-mara/tar-raġel) waqt li jkunu qed jingħataw everolimus, u sa 8 ġimgħat wara li tintemm il-kura.
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Afinitor (see section 4.8).
Maltese: Stomatite, inkluż ulċeri fil-ħalq u mukożite orali, hi l-aktar reazzjoni avversa komuni rrappurtata f'pazjenti kkurati b'Afinitor (ara sezzjoni 4.8).
English: Stomatitis is the most commonly reported adverse reaction in patients treated with Afinitor (see sections 4.4 and 4.8).
Maltese: Stomatite hi l-aktar reazzjoni avversa komuni rrappurtata f'pazjenti kkurati b'Afinitor (ara sezzjonijiet 4.4 u 4.8).
English: An interaction study in healthy subjects demonstrated that co-administration of an oral dose of midazolam, a sensitive CYP3A substrate probe, with everolimus resulted in a 25% increase in midazolam Cmax and a 30% increase in midazolam AUC(0-inf).
Maltese: Studju ta' interazzjoni f'suġġetti b'saħħithom wera li l-għoti ta' doża ta' midazolam mill-ħalq, sonda ta' substrat ta' CYP3A, sensittiv, ma' everolimus wassal għal żieda ta' 25% ta' midazolam fis-Cmax u għal żieda ta' 30% fl-AUC(0-inf) ta' midazolam.
English: Log-rank p value = <0.001
Maltese: Il-valur p log-rank = <0.
English: Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or 90 tablets.
Maltese: Afinitor 5 mg u Afinitor 10 mg huma disponibbli f'pakketti ta' folji li fihom 10, 30 jew 90 pillola.
English: Common Haemorrhage b, hypertension
Maltese: Emorraġija b, pressjoni għolja
English: Includes (very common) stomatitis, (common) aphthous stomatitis, mouth and tongue ulceration and (uncommon) glossodynia, glossitis e
Maltese: Tinkludi (komuni ħafna) stomatite, (komuni) u stomatite bl-afta, ulċeri fil-ħalq u fl-ilsien u (mhux komuni) glossodinea, glossite e
English: EU/1/09/538/008 10 tablets EU/1/09/538/004 30 tablets EU/1/09/538/006 90 tablets
Maltese: EU/1/09/538/008 10 pilloli EU/1/09/538/004 30 pillola EU/1/09/538/006 90 pillola
English: Afinitor 10 mg tablets Packs containing 10, 30 or 90 tablets.
Maltese: Afinitor 10 mg pilloli Pakketti fihom 10, 30 jew 90 pillola.
English: EU/1/09/538/007 10 tablets EU/1/09/538/001 30 tablets EU/1/09/538/003 90 tablets
Maltese: EU/1/09/538/007 10 pilloli EU/1/09/538/001 30 pillola EU/1/09/538/003 90 pillola
English: Hazard Ratio = 0.35
Maltese: HR=0.43
English: If patients require co-administration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg daily or 2.5 mg daily may be considered.
Maltese: Jekk il-pazjenti jeħtieġu li jingħataw ukoll impeditur moderat ta' CYP3A4 jew ta' PgP, tista' tikkunsidra li tnaqqas id-doża għal 5 mg kuljum jew għal 2,5 mg kuljum.
English: Afinitor 5 mg tablets Packs containing 10, 30 or 90 tablets.
Maltese: Afinitor 5 mg pilloli Pakketti fihom 10, 30 jew 90 pillola.
English: The efficacy results for the primary endpoint were obtained from the final PFS analysis (see Table 6 and Figure 4).
Maltese: Ir-riżultati tal-effikaċja għall-endpoint primarju nkisbu minn analiżi finali tal-PFS (ara Tabella 6 u Figura 4).
English: The median duration of exemestane treatment was longer in the everolimus + exemestane group at 29.5 weeks (1.0-199.1) compared to 14.1 weeks (1.0-156.0) in the placebo + exemestane group.
Maltese: 5 ġimgħat (1.0-199.1) imqabbel mal-14.1 ġimgħat (1.0-156.0) fil-grupp mogħti plaċebo + exemestane.
English: Figure 4 RADIANT-4 - Kaplan-Meier progression-free survival curves (independent radiological review)
Maltese: Kaplan-Meier tas-sopravivenza medja tal progressjoni ħielsa (valutazzjoni radjoloġika indipendenti)
English: Very common Weight decreased * See also subsection “Description of selected adverse reactions”
Maltese: Komuni ħafna Tnaqqis fil-piż * Ara wkoll s-sottosezzjoni “Deskrizzjoni tar-reazzjonijiet mhux mixtieqa magħżula”
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Maltese: Is- Cmax huwa fi proporzjon mad-doża bejn id-dożi ta' 5 u 10 mg. tmax jseħħ minn siegħa sa sagħtejn wara li tingħata d-doża.
English: The effect is likely to be due to inhibition of intestinal CYP3A4 by everolimus.
Maltese: Huwa probabbli li l-effett iseħħ minħabba l-impediment ta' CYP3A4 fl-imsaren minn everolimus.
English: Based on analysis of population pharmacokinetics, CL/F is on average 20% higher in black transplant patients.
Maltese: Fuq bażi ta' analiżi farmakokinetika tal-popolazzjoni, CL/F hija ta' madwar 20% ogħla f'pazjenti suwed bi trapjant.
English: Mean oral clearance (CL/F) of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Maltese: Il-medja tat-tneħħija orali (CL/F) ta' everolimus wara doża ta' 10 mg kuljum f'pazjenti b'tumuri solidi avanzati kienet ta' 24.5 l/siegħa.
English: Grade 3 (<1, ≥0.5x10
Maltese: Grad 3 (<1, ≥0.
English: • Breathlessness (dyspnoea)
Maltese: • Tinfaġar (epistassi)
English: Common Thrombocytopenia, neutropenia, leukopenia, lymphopenia Uncommon Pancytopenia
Maltese: Tromboċitopenija, newtropenija, lewkopenija, limfopenija Mhux komuni Panċitopenija Rari
English: If toxicity recurs at Grade 3, consider discontinuation.
Maltese: Jekk jerġa' jkun hemm tossiċità fi Grad 3, ikkunsidra li tieqaf.
English: Following disease progression or after study unblinding, 172 of the 203 patients (84.7%) initially randomised to placebo crossed over to open-label Afinitor.
Maltese: Wara progressjoni tal-marda jew wara li nkixef x'kienu qed jirċievu l-pazjenti fl-istudju, 172 mill203 pazjenti (84.7%) inizjalment randomised għal plaċebo qalbu għal Afinitor open-label.
English: Results of the secondary endpoint OS were not consistent with the primary endpoint PFS, with a trend observed favouring the everolimus alone arm.
Maltese: Ir-riżultati tal-endpoint sekondarju tal-OS ma kinux konsistenti mal-endpoint primarju tal-PRFS, b'tendenza osservata li tiffavorixxi l-grupp mogħti everolimus waħdu.
English: Prior chemotherapy Primary tumour origin
Maltese: Oriġini tat-tumur primarju
English: Afinitor 5 mg tablets Each tablet contains 5 mg everolimus.
Maltese: Afinitor 5 mg pilloli Kull pillola fiha 5 mg everolimus.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Very common Decreased appetite, hyperglycaemia, hypercholesterolaemia Common Hypertriglyceridaemia, hypophosphataemia, diabetes mellitus, hyperlipidaemia,
Maltese: Ipertrigliċeridemija, ipofosfatemija, dijabete mellitus, iperlipidemija, ipokalemija, deidrazzjoni, ipokalċemija Disturbi psikjatriċi Komuni
English: • Dry mouth
Maltese: • Uġigħ ta' żaqq
English: Secondary endpoints included overall survival (OS), objective response rate, clinical benefit rate, safety, change in quality of life (QoL) and time to ECOG PS (Eastern Cooperative Oncology Group performance status) deterioration.
Maltese: Endpoints sekondarji kienu jinkludu sopravivenza totali (OS), rata oġġettiva ta' rispons, rata ta' benefiċċju kliniku, sigurtà, tibdil fil-kwalità tal-ħajja (QoL) u kemm idumu biex jaqilbu għall-agħar ta' ECOG PS (L-istat ta' wirja tal-Grupp dwar l-Onkoloġija Kooperattiva tal-Lvant).
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by RECIST (Response Evaluation Criteria in Solid Tumors), based on the investigator's assessment (local radiology).
Maltese: L-endpoint primarju għall-istudju kien is-sopravivenza ħielsa minn progressjoni (PFS) evalwata b'RECIST (Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi), imsejjes fuq l-evalwazzjoni tal-investigatur (radjoloġija lokali).
English: Common Dry skin, nail disorders, mild alopecia, acne, erythema, onychoclasis, palmar-plantar erythrodysaesthesia syndrome, skin exfoliation, skin lesion
Maltese: Ġilda xotta, disturbi fid-dwiefer, alopeċja ħafifa, akne, eritema, onikoklasi, Sindromu tal-eritrodisasteżija palmari-plantari, ġilda titqaxxar, feriti fil-ġilda
English: Common Proteinuria*, blood creatinine increased, renal failure* Uncommon Increased daytime urination, acute renal failure* Reproductive system and breast disorders Common Menstruation irregular e
Maltese: Proteinuria*, żieda fil-kreatinina fid-demm, insuffiċjenza tal-kliewi* Mhux komuni Żieda fl-ammont ta' awrina li tgħaddi mal-ġurnata, insuffiċjenza akuta tal-kliewi* Disturbi fis-sistema riproduttiva u fis-sider
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with serious cases of hepatitis B reactivation, including fatal outcome.
Maltese: Fl-istudji kliniċi u skont rapporti spontanji wara t-tqegħid fis-suq, everolimus ġie assoċjat ma' każi serji ta' attivazzjoni mill-ġdid tal-epatite B, inkluż b'riżultat fatali.
English: Administration of everolimus for up to 2 years did not indicate any oncogenic potential in mice and rats up to the highest doses, corresponding respectively to 3.9 and 0.2 times the estimated clinical exposure.
Maltese: L-għoti ta' everolimus sa sentejn ma indikax potenzjal onkoġeniku fil-ġrieden u l-firien sal-ogħla dożi, li jikkorrispondi rispettivament għal 3.9 u 0.2 drabi l-esponiment kliniku stmat.
English: Uncommon Congestive cardiac failure Vascular disorders
Maltese: Mhux komuni Insuffiċjenza konġestiva tal-qalb Disturbi vaskulari
English: S6K1is thought to phosphorylate the activation function domain 1 of the oestrogen receptor, which is responsible for ligand-independent receptor activation.
Maltese: Hu maħsub li S6K1 jiffosforizza l-attivazzjoni tal-funzjoni tad-dominju 1 tar-riċettur ta' estroġenu, li hu responsabbli mill-attivazzjoni tar-riċettur dipendenti fuq il-ligand.
English: Afinitor is an anticancer medicine containing the active substance everolimus.
Maltese: Afinitor huwa mediċina kontra l-kanċer li fih is-sustanza attiva everolimus.
English: Number of Patients still at Risk
Maltese: Numru ta' pazjenti li baqgħu f'riskju
English: Median progression-free survival (months) (95% CI) Investigator radiological review 7.8
Maltese: Sopravivenza medja tal-progressjoni ħielsa (xhur) (95% CI) Analiżi radjoloġika mill-investigatur
English: BOLERO-6 (Study CRAD001Y2201), a three-arm, randomised, open-label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with oestrogen receptor-positive, HER2/neu negative, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole.
Maltese: II dwar everolimus fost tliet gruppi, randomizzat, open-label mogħti flimkien ma' exemestane kontra everolimus waħdu kontra capecitabine għattrattament ta' nisa wara l-menopawża bl-estroġenu tar-riċettur pożittiv, b'HER2/neu kanċer tas-sider negattiv, avvanzat lokalment, b'rikorrenza, jew metastatiku wara b'rikorrenza jew progressjoni qabel letrozole jew anastrozole.
English: The primary objective of the study was to estimate the HR of PFS for everolimus + exemestane versus everolimus alone.
Maltese: L-objettiv primarju tal-istudju kien li jevalwa l-HR ta' PFS għal everolimus + exemestane kontra everolimus waħdu.
English: For adverse reactions of Grade 1, dose adjustment is usually not required.
Maltese: Għal reazzjonijiet avversi ta' Grad 1, normalment mhux meħtieġ aġġustament tad-doża.
English: Concomitant treatment with potent CYP3A4 inhibitors result in dramatically increased plasma concentrations of everolimus (see section 4.5).
Maltese: Meta l-kura tingħata flimkien ma' impedituri potenti ta' CYP3A4 din twassal għal żieda kbira fil-konċentrazzjonijiet tal-plażma (ara sezzjoni 4.5).
English: • Dry skin, skin exfoliation, skin lesions
Maltese: • Ġilda xotta, qxur fil-ġilda, feriti fil-ġilda
English: The median duration of blinded study treatment was 141 days (range 19-451 days) for patients receiving everolimus and 60 days (range 21-295 days) for those receiving placebo.
Maltese: Id-dewmien medjan tal-kura waqt l-istudju blinded kien ta' 141 jum (medda ta' 19-451 jum) għal pazjenti mogħtija everolimus u ta' 60 jum (medda ta' 21-295 jum) għal dawk mogħtija plaċebo
English: Contains lactose.
Maltese: Ma ġietx studjata.
English: Non-infectious pneumonitis (including interstitial lung disease) has been frequently reported in patients taking Afinitor (see section 4.8).
Maltese: Il-pulmonite mhux infettiva (inkluż mard tal-interstizju tal-pulmun) ġiet irrapurtata b'mod frekwenti f'pazjenti li qed jieħdu Afinitor (ara sezzjoni 4.8).
English: If co-administration of a moderate CYP3A4 and/or PgP inhibitor or inducer cannot be avoided, dose adjustments of Afinitor can be taken into consideration based on predicted AUC (see section 4.5).
Maltese: Jekk ma jistax jiġi evitat li CYP3A4 moderat u/jew l-impeditur jew l-induttur PgP jingħataw flimkien, wieħed jista' jikkunsidra li jaġġusta d-doża ta' Afinitor skont l-AUC mbassra (ara sezzjoni 4.5).
English: The safety, tolerability and pharmacokinetics of everolimus were evaluated in two single oral dose studies of Afinitor tablets in 8 and 34 subjects with impaired hepatic function relative to subjects with normal hepatic function.
Maltese: Is-sigurtà, it-tollerabbilità u l-farmakokinetika ta' everolimus ġew stmati f'żewġ studji b'doża waħda ta' pilloli Afinitor mill-ħalq fi 8 u 34 individwu b'indeboliment tal-funzjoni tal-fwied meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: Following documented radiological progression, patients could be unblinded by the investigator.
Maltese: Wara li saret dokumentazzjoni b'mod radjoloġiku tal-progressjoni, l-investigatur seta' ma jħallix aktar il-pazjenti blinded.
English: Randomisation was stratified by documented sensitivity to prior hormonal therapy and by the presence of visceral metastasis.
Maltese: Ir-randomizzazzjoni kienet stratifikata skont is-sensittività ddokumentata għal terapija ormonali mogħtija qabel u skont il-preżenza ta' metastasi vixxerali.
English: • Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in your lungs become blocked)
Maltese: • Qtugħ ta' nifs għal għarrieda, uġigħ f'sidrek jew tisgħol u taqta' bili bid-demm (sinjali potenzjali ta' emboliżmu pulmonari, kundizzjoni li sseħħ meta waħda jew aktar mill-arterji tal-pulmun tiegħek tkun imblukkata)
English: Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus.
Maltese: Afinitor 2.5 mg pilloli Kull pillola fiha 2.5 mg everolimus.
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
Maltese: Waqt studji kliniċi u rapporti spontanji (mhux mitluba) li daħlu wara t-tqegħid tal-prodott fis-suq, everolimus kien assoċjat ma' episodji ta' insuffiċjenza tal-kliewi (inkluż b'riżultat fatali) u ta' proteinuria.
English: • Loss of appetite
Maltese: • Nuqqas ta' aptit
English: • Disturbed taste (dysgeusia)
Maltese: • Diffikultà biex tibla' (disfaġja)
English: In a randomised, double-blind, multi-centre trial in patients with functional carcinoid tumours, Afinitor plus depot octreotide was compared to placebo plus depot octreotide.
Maltese: Waqt prova randomizzata, double-blind, multiċentrika fost pazjent b'tumuri karċinojdi funzjonali, Afinitor flimkien ma' depot octreotide tqabbel ma' plaċebo flimkien ma' depot octreotide.
English: Agents whose plasma concentration may be altered by everolimus Based on in vitro results, the systemic concentrations obtained after oral daily doses of 10 mg make inhibition of PgP, CYP3A4 and CYP2D6 unlikely.
Maltese: Aġenti li l-konċentrazzjoni tagħhom tal-plażma tista' titbiddel b'everolimus Skont riżultati in vitro, il-konċentrazzjonijiet sistemiċi miksuba wara li ngħatat doża orali ta' 10 mg kuljum ma jgħinux biex ikun hemm impediment ta' PgP, CYP3A4 u CYP2D6.
English: If Afinitor is taken with orally administered CYP3A4 substrates with a narrow therapeutic index (e.g. pimozide, terfenadine, astemizole, cisapride, quinidine or ergot alkaloid derivatives), the patient should be monitored for undesirable effects described in the product information of the orally administered CYP3A4 substrate (see section 4.5).
Maltese: Jekk Afinitor jittieħed flimkien ma' substrati ta' CYP3A4 li jittieħdu mill-ħalq b'indiċi terapewtiku dejjaq (eż. pimozide, terfenadine, astemizole, cisapride, quinidine jew derivati ta' ergot alkaloids), il-pazjent għandu jiġi mmonitorjat għal effetti mhux mixtieqa deskritti fl-informazzjoni dwar il-prodott rigward is-substrat ta' CYP3A4 mogħti mill-ħalq (ara sezzjoni 4.5).
English: If you forget to take Afinitor
Maltese: Żminijiet ta' ċensura