FrancophonIA/ELRC3.0 huggingface dataset:
English: In a post-marketing single-arm study in postmenopausal women with advanced breast cancer (N=92), topical treatment with dexamethasone 0.5 mg/5 ml alcohol-free oral solution was administered as a mouthwash (4 times daily for the initial 8 weeks of treatment) to patients at the time of initiating treatment with Afinitor (10 mg/day) plus exemestane (25 mg/day) to reduce the incidence and severity of stomatitis.
Maltese: Skont studju magħmul wara t-tqegħid tal-prodott fis-suq fost grupp wieħed ta' nisa li kellhom kanċer fis-sider avvanzat wara l-menopawża (N=92), ingħata trattament topiku b'dexamethasone 0.5 mg/5ml soluzzjoni orali mingħajr alkoħol mogħtija bħala likwidu għat-tlaħliħ tal-ħalq (4 darbiet kuljum għall-ewwel 8 ġimgħat ta' trattament) lil pazjenti mat-tnedija tat-trattament b'Afinitor (10 mg/jum) flimkien ma' exemestane (25 mg/jum) sabiex tonqos l-inċidenza u l-gravità ta' stomatite.
English: After documented radiological progression, patients could be unblinded by the investigator: those randomised to placebo were then able to receive open-label everolimus 10 mg/day.
Maltese: Wara progressjoni dokumentata b'mod radjoloġiku, il-pazjenti setgħu jiġu unblinded mill-investigatur: dawk li nzertaw ingħażlu biex jingħataw il-plaċebo setgħu mbagħad jingħataw everolimus open-label 10 mg kuljum.
English: However, the corresponding oestradiol levels at steady state (4 weeks) were not different between the two treatment arms.
Maltese: Madanakollu, il-livelli oestradjoli korrispondenti fi stat stabbli (4 ġimgħat) ma kienux differenti bejn iż-żewġ gruppi ta' kura.
English: Grade 2 Temporary dose interruption until recovery to Grade 1.
Maltese: Grad 2 Waqqaf temporanjament id-doża sakemm dak li jkun ma jirkuprax għal  Grad 1.
English: The median duration of blinded study treatment was 37.8 weeks (range 1.1-129.9 weeks) for patients receiving everolimus and 16.1 weeks (range 0.4-147.0 weeks) for those receiving placebo.
Maltese: Id-dewmien medjan tal-kura waqt l-istudju blinded kien ta' 37.8 ġimgħat (medda ta' 1.1-129.9 ġimgħat) għal pazjenti mogħtija everolimus u ta' 16.1 ġimgħat (medda ta' 0.4-147.0 ġimgħat) għal dawk mogħtija plaċebo.
English: Median overall survival (months) (95% CI) Median overall survival
Maltese: Sopravivenza globali medjana (xhur) (95% CI) Sopravivenza globali medjana
English: Plus exemestane b
Maltese: Flimkien ma' exemestane b
English: Poor risk a
Maltese: Riskju mhux tajjeb a
English: • Tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, possibly due to a type of anaemia called pure red cell aplasia)
Maltese: • Għeja, qtugħ ta' nifs, sturdament, ġilda pallida (sinjali ta' livell baxx ta' ċelluli ħomor tad-demm, possibbilment minħabba tip ta' anemija msejħa aplasija pura taċ-ċelluli l-ħomor)
English: Hyperglycaemia has been reported (see section 4.8).
Maltese: Huwa rrakkomandat li jkun hemm osservazzjoni tal-funzjoni tal-kliewi (ara sezzjoni 4.4).
English: Median progression-free survival (months) (95% CI)
Maltese: Sopravivenza medja tal-progressjoni ħielsa (xhur) (95% CI)
English: Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Maltese: Kull pillola ta' Afinitor 10 mg fiha 10 mg everolimus.
English: • Menstruation disorders such as irregular periods
Maltese: • Disturbi fil-menstrwazzjoni bħal pirjids irregolari
English: Sensitivity to prior hormonal therapy was defined as either (1) documented clinical benefit (complete response [CR], partial response [PR], stable disease ≥24 weeks) from at least one prior hormonal therapy in the advanced setting or (2) at least 24 months of adjuvant hormonal therapy prior to recurrence.
Maltese: Is-sensittività għal terapija ormonali mgħoddija kienet definita jew bħala (1) benefiċċju kliniku ddokumentat (rispons sħiħ [CR], rispons parzjali [PR], marda stabbli ≥24 ġimgħa) minn mill-inqas terapija ormonali mgħoddija waħda f'qagħda avvanzata jew (2) mill-inqas 24 xahar ta' terapija ormonali adjuvanti qabel ir-rikorrenza.
English: • High level of lipids (fats) in the blood (hypercholesterolaemia)
Maltese: • Livelli għoljin ta' lipidi (xaħmijiet) fid-demm (iperkolesterolemija)
English: In total, 410 patients were randomised 1:1 to receive either Afinitor 10 mg/day (n=207) or placebo (n=203).
Maltese: B'kollox, 410 pazjenti kienu randomizzati 1:1 biex jieħdu jew 10 mg/kuljum Afinitor (n=207) jew plaċebo (n=203).
English: The potential for everolimus to cause infertility in male and female patients is unknown, however amenorrhoea (secondary amenorrhoea and other menstrual irregularities) and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients.
Maltese: Il-potenzjalità għal everolilmus li jikkawża infertilità f'pazjenti rġiel u nisa mhix magħrufa, madanakollu kien osservat żbilanċ fl-amenorrea (amenorrea sekondarja u irregolaritajiet oħra tal-menstrwazzjoni) u fl-ormon luteinizzanti assoċjat (LH)/ormon li jistimula l-follikulu f'pazjenti nisa.
English: • Severely decreased urine output (sign of kidney failure)
Maltese: • Tnaqqis gravi li tgħaddi awrina (sinjal ta' insuffiċjenza tal-kliewi)
English: • Loss of sense of taste (ageusia)
Maltese: • Titlef is-sens tat-togħma (agweżja)
English: Table 5 RADIANT-3 - efficacy results
Maltese: Figura 3 RADIANT-3 - Kurvi
English: Acute respiratory distress syndrome Gastrointestinal disorders Very common Stomatitis d, diarrhoea, nausea
Maltese: Sindromu ta' disturb respiratorju akut Disturbi gastrointestinali Komuni ħafna Stomatite d, dijarea, dardir
English: Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Maltese: Kull pillola ta' Afinitor 2.5 mg fiha 2.5 mg everolimus.
English: Limited evidence of PFS benefit was reported in the subgroup of patients with ileum as primary tumour origin (see section 5.1).
Maltese: L-evidenza rrapurtata kienet waħda limitata fuq il-benefiċċju tal-PFS fis-sottogrupp tal-pazjenti bl-ilju bħala l-oriġini ta' tumur primarju (ara sezzjoni 5.1).
English: Frequency based upon number of women from 10 to 55 years of age in the pooled data
Maltese: Frekwenza bbażata fuq numru ta' nisa minn 10 snin sa 55 sena fid-dejta miġbura
English: The median duration of open-label treatment was 47.7 weeks among all patients; 67.1 weeks in the 53 patients randomised to everolimus who switched to open-label everolimus and 44.1 weeks in the 172 patients randomised to placebo who switched to open-label everolimus.
Maltese: 7 ġimgħat fost il-pazjenti kollha; 67.1 ġimgħa fit-53 pazjent randomised għal everolimus li qalbu għal everolimus open-label u 44.1 ġimgħa fil-172 pazjent randomised għal plaċebo li qalbu għal everolimus open-label.
English: The number of patients with an adverse reaction leading to discontinuation of the medicinal product was higher in patients ≥65 years of age (20% vs. 13%).
Maltese: L-għadd ta' pazjenti b'reazzjoni avversa li twassal għal twaqqif tal-prodott mediċinali kien ogħla f'pazjenti ta' ≥65 sena (20% vs. 13%).
English: Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Maltese: Afinitor 2.5 mg huwa disponibbli f'pakketti ta' folji li fihom 30 jew 90 pillola.
English: RECORD-1 (study CRAD001C2240), a phase III, international, multicentre, randomised, double-blind study comparing everolimus 10 mg/day and placebo, both in conjunction with best supportive care, was conducted in patients with metastatic renal cell carcinoma whose disease had progressed on or after treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (sunitinib, sorafenib, or both sunitinib and sorafenib).
Maltese: III, li jqabbel everolimus 10 mg kuljum ma' plaċebo, it-tnejn li huma flimkien mal-aħjar kura ta' appoġġ, sar f'pazjenti b'kanċer metastatika taċ-ċelluli tal-kliewi li l-marda tagħhom kienet infirxet waqt jew wara l-kura b'terapija b'VEGFR-TKI (impeditur tyrosine kinase tar-riċettur tal-fattur ta' tkabbir vaskulari tal-endotelju) (sunitinib, sorafenib, jew kemm sunitinib kif ukoll sorafenib).
English: Psychiatric disorders Common Insomnia Nervous system disorders Very common Dysgeusia, headache Uncommon Ageusia Eye disorders
Maltese: Disturbi fis-sistema nervuża Komuni ħafna Diżgweżja, uġigħ ta' ras Mhux komuni Agweżja
English: Hormone receptor-positive advanced breast cancer BOLERO-2 (study CRAD001Y2301), a randomised, double-blind, multicentre phase III study of Afinitor + exemestane versus placebo + exemestane, was conducted in postmenopausal women with oestrogen receptor-positive, HER2/neu negative advanced breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.
Maltese: III ta' Afinitor + exemestane imqabbla ma' plaċebo + exemestane, sar fost nisa wara l-menopawża b'riċettur tal-estroġenu pożittiv, HER2/neu kanċer tas-sider avvanzat negattiv b'rikorrenza jew progressjoni wara terapija b'letrozole jew anastrozole.
English: The use of live vaccines should be avoided during treatment with Afinitor (see section 4.4).
Maltese: L-użu ta' tilqim ħaj għandu jiġi evitat waqt kura b'Afinitor (ara sezzjoni 4.4).
English: In the first study, the average AUC of everolimus in 8 subjects with moderate hepatic impairment (Child-Pugh B) was twice that found in 8 subjects with normal hepatic function.
Maltese: Fl-ewwel studju, l-AUC medja ta' everolimus fi 8 individwi b'indeboliment moderat tal-funzjoni tal-fwied (Child-Pugh B) kienet id-doppju ta' dik osservata fi 8 individwi b'funzjoni normali tal-fwied.
English: For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP/PCP may be considered.
Maltese: Għal pazjenti li jeħtieġu l-użu ta' kortikosterojdi għall-kura ta' pulmonite mhux infettiva, tista' tiġi kkunsidrata profilassi għal PJP/PCP.
English: The study did not meet the primary efficacy endpoint (progression-free-survival [PFS]) and the overall survival (OS) interim analysis numerically favoured the placebo plus depot octreotide arm.
Maltese: L-istudju ma laħaqx l-endpoint ta' effikaċja (sopravivenza mingħajr progressjoni [PFS]) u s-sopravivenza totali [OS] analiżi interim iffavorixxiet numerikament il-grupp mogħti l-plaċebo flimkien ma' depot octreotide.
English: Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1).
Maltese: Tumuri newroendokriniċi ta' oriġini gastrointestinali jew pulmonari Afinitor huwa indikat għall-kura ta' tumuri newroendokriniċi mhux operabbli jew metastatiċi ta' oriġini gastrointestinali jew pulmonari b'differenzi sew (Grad 1 jew Grad 2) f'adulti b'marda progressiva (ara sezzjonijiet 4.4 u 5.1).
English: Grapefruit juice or other food affecting CYP3A4/PgP
Maltese: Meraq ta' tronġ jew ikel ieħor li jaffettwa s-CYP3A4/PgP
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic reaction, also known as hypersensitivity)
Maltese: • Raxx, ħakk, morliti, diffikultà biex tieħu n-nifs jew tibla', sturdament (sinjali ta' reazzjoni allerġika serja, magħufa wkoll bħala ipersensittività)
English: If patients require co-administration of a potent CYP3A4 inducer, an Afinitor dose increase from 10 mg daily up to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer.
Maltese: Jekk il-pazjenti jeħtieġu li jingħatw ukoll induttur qawwi ta' CYP3A4, wieħed għandu jikkunsidra li jżid id-doża ta' Afinitor minn 10 mg kuljum għal 20 mg kuljum b'żieda ta' 5 mg kull darba jew inqas applikabbli fir-4 u t-8 ġurnata wara li jinbeda l-induttur.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (see section 4.4).
Maltese: Il-pazjenti li qed jieħdu fl-istess ħin terapija b'inibitur ta' ACE (e.g. ramipril) jistgħu jkunu f'riskju akbar ta' anġjoedima (ara sezzjoni 4.4).
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by Response Evaluation Criteria in Solid Tumors (RECIST), based on independent radiology assessment.
Maltese: L-endpoint primarju tal-istudju kien is-sopravivenza ħielsa minn progressjoni (PFS) evalwata millKriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST), ibbażat fuq valutazzjoni radjoloġika indipendenti.
English: There was a significant correlation between AUC0-τ and pre-dose trough concentration at steady-state.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl u mill-umdità.
English: Steady-state pharmacokinetics
Maltese: Farmakokinetika fl-istat fiss
English: The most common adverse reactions leading to discontinuation were pneumonitis (including interstitial lung disease), stomatitis, fatigue and dyspnoea.
Maltese: L-aktar reazzjoni avversa li twassal għal twaqqif kienu l-pulmonite (inkluż mard tal-interstizju tal-pulmun), l-istomatite, l-għeja u d-dispnea.
English: The result of the final PFS analysis with 154 PFS events observed based on local investigator assessment showed an estimated HR of 0.74 (90% CI: 0.57, 0.97) in favour of the everolimus + exemestane arm relative to everolimus arm.
Maltese: HR stmat ta' 0.74 (90% CI: 0.57, 0.97) favur il-grupp mogħti everolimus + exemestane imqabbel mal-grupp mogħti everolimus.
English: • Heartburn (dyspepsia)
Maltese: • Ħruq fl-istonku (dispepsja)
English: • Swelling of arms, hands, feet, ankles or other part of the body (signs of oedema)
Maltese: • Nefħa fid-dirgħajn, fl-idejn, riġlejn, għekiesi jew partijiet oħra tal-ġisem (sinjali ta' edema)
English: Common Eyelid oedema Uncommon Conjunctivitis Cardiac disorders
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Anemija Komuni
English: • Skin rash
Maltese: Studji oħrajn
English: Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Maltese: Kull pillola ta' Afinitor 5 mg fiha 5 mg everolimus.
English: Tumour grading Liver tumour burden
Maltese: Jekk tinsa tieħu Afinitor
English: • Severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure)
Maltese: • Tnaqqis gravi fl-ammont ta' awrina mgħoddija, riġlejn minfuħin, tħossok imħawwad, uġigħ f'dahrek (sinjali ta' insuffiċjenza f'daqqa waħda fil-kliewi)
English: Prognostic factors in neuroendocrine tumours of gastrointestinal or lung origin In patients with non-functional gastrointestinal or lung neuroendocrine tumours and good prognostic baseline factors, e.g. ileum as primary tumour origin and normal chromogranin A values or without bone involvement, an individual benefit-risk assessment should be performed prior to the start of Afinitor therapy.
Maltese: F'pazjenti b'tumuri gastrointestinali jew newroendokrini pulmonari mhux funzjonali u b'fatturi pronjostiċi tajbin fil-linja bażi, eż. ilju bħala l-oriġini ta' tumur primarju u valuri A kromogranini normali bis-sehem, jew mingħajr is-sehem, tal-għadam, għandha ssirilhom evalwazzjoni individwali tar-riskji u l-benefiċji qabel it-tnedija tat-terapija b'Afinitor.
English: Approximately 20% of the everolimus concentration in whole blood is confined to plasma in cancer patients given everolimus 10 mg/day.
Maltese: Madwar 20% tal-konċentrazzjoni ta' everolimus fid-demm sħiħ jinsab fil-plażma ta' pazjenti bil-kanċer li ngħataw 10 mg everolimus kuljum.
English: Figure 2 BOLERO-6 Kaplan-Meier progression-free survival curves (investigator radiological review)
Maltese: Kaplan-Meier ta' sopravivenza ħielsa minn progressjoni (analiżi radjoloġika investigattiva)
English: Known and theoretical interactions with selected inhibitors and inducers of CYP3A4 and PgP are listed in Table 2 below.
Maltese: F'Tabella 2 hawn taħt hemm lista ta' interazzjonijiet magħrufa u teoretiċi ma' impedituri u indutturi magħżula ta' CYP3A4 u PgP.
English: Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Maltese: Everolimus mhuwiex irrakkomandat waqt it-tqala u f'nisa li jistgħu joħorġu tqal li mhumiex qed jużaw kontraċezzjoni.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors Patients taking concomitant ACE inhibitor (e.g. ramipril) therapy may be at increased risk for angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment) (see section 4.5).
Maltese: Il-pazjenti li qed jieħdu fl-istess ħin terapija b'inibitur ta' ACE (e.g. ramipril) jistgħu jkunu f'riskju akbar ta' anġjoedima (eż. nefħa tal-passaġġi tal-arja jew tal-ilsien, b'indeboliment respiratorju jew le) (ara sezzjoni 4.5).
English: Renal function should be monitored particularly where patients have additional risk factors that may further impair renal function.
Maltese: Għandu jkun hemm osservazzjoni tal-funzjoni tal-kliewi, b'mod partikulari f'dawk il-pazjenti li għandhom fatturi ta' riskju addizzjonali li jistgħu jxekklu aktar il-funzjoni tal-kliewi.
English: Advanced neuroendocrine tumours of gastrointestinal or lung origin RADIANT-4 (study CRAD001T2302), a randomised, double-blind, multicentre, phase III study of Afinitor plus best supportive care (BSC) versus placebo plus BSC was conducted in patients with advanced, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin without a history of and no active symptoms related to carcinoid syndrome.
Maltese: Tumuri newroendokrinali avvanzati ta' oriġini gastrointestinali jew pulmunari RADIANT-4 (studju CRAD001T2302), sar studju randomizzat, double-blind, multiċentriku, tal-fażi
English: • Fever, skin rash, joint pain and inflammation, as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)
Maltese: • Deni, raxx fil-ġilda, uġigħ u infjammazzjoni fil-ġogi, kif ukoll għeja, nuqqas ta' aptit, dardir, suffejra (il-ġilda tisfar), uġigħ fuq il-lemin tan-naħa ta' fuq taż-żaqq, ippurgar lewn it-tafal, awrina skura (jistgħu jkunu sinjali ta' riattivazzjoni tal-epatite B)
English: Potent and moderate CYP3A4 inducers Rifampicin
Maltese: Indutturi qawwija u moderati ta' CYP3A4
English: After administration of everolimus in patients with advanced solid tumours, steady-state AUC0-τ was dose-proportional over the range of 5 to 10 mg daily dose.
Maltese: Wara l-għoti ta' everolimus f'pazjenti b'tumuri solidi avanzati, l- AUC0-τ fl-istat fiss kienet fi proporzjon mad-doża fuq il-medda ta' doża bejn 5 u 10 mg kuljum.
English: The safety profile is based on pooled data from 2,879 patients treated with Afinitor in eleven clinical studies, consisting of five randomised, double-blind, placebo controlled phase III studies and six open-label phase I and phase II studies, related to the approved indications.
Maltese: Il-profil ta' sigurtà jissejjes fuq dejta miġbura minn 2,879 pazjenti ttrattati b'Afinitor waqt ħdax-il studju kliniku, li kienu jikkonsistu f'ħames studji bil-plaċebo f'fażi
English: Log-rank p value = <0.0001
Maltese: Mhux ilju: HR=0.34
English: • Mouth ulcers
Maltese: NUMRU TAL-LOT
English: Decreased exposure expected.
Maltese: Mistenni tnaqqis fl-espożizzjoni.
English: Take the carton and this leaflet, so that the doctor knows what has been taken.
Maltese: Mhux komuni Uġigħ fis-sider mhux kardijaku, nuqqas ta' fejqan ta' feriti Investigazzjonijiet
English: Baseline CgA
Maltese: Reazzjoni Avversa
English: However, oral doses of everolimus in female rats at ≥0.1 mg/kg (approximately 4% of the AUC0-24h in patients receiving the 10 mg daily dose) resulted in increases in pre-implantation loss.
Maltese: Madankollu, dożi orali ta' everolimus f'firien femminili ta' ≥0.1 mg/kg (madwar 4% tal-AUC0-24siegħa f'pazjenti li jirċievu d-doża ta' 10 mg kuljum) wasslu għal żidiet fit-telf tal-fetu qabel l-impjantazzjoni.
English: Invented name Strength Pharmaceutical form Route of administration Immediate packaging
Maltese: Isem inventat Qawwa
English: Ref.: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
Maltese: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
English: Catherine Moraiti (Greece)
Maltese: Catherine Moraiti (Il-Greċja)
English: Lescol contains the active substance fluvastatin.
Maltese: Lescol fih is-sustanza attiva fluvastatina.
English: London, 15 March 2010 Doc.
Maltese: Londra, 15 ta' Marzu 2010
English: Lescol is also available in the EU under other trade names: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon and Vaditon Prolib.
Maltese: Lescol huwa disponibbli fl-UE b'ismijiet kummerċjali oħrajn: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon u Vaditon Prolib.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: Artikolu 30 tad-Direttiva 2001/83/KE kif emendat, referenza fuq il-bażi ta' deċiżjonijiet diverġenti adottati minn Stati Membri
English: What is Lescol?
Maltese: X'inhu Lescol?
English: HMG-CoA reductase is responsible for the production of cholesterol.
Maltese: L-HMG-CoA reduttażi hija responsabbli mill-produzzjoni talkolesterol.
English: Company responses provided on: 29 May 2009, 16 October 2009 Opinion date:
Maltese: It-tweġibiet tal-kumpanija ngħataw: 29 ta' Mejju 2009, 16 ta' Ottubru 2009 Data tal-opinjoni:
English: Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg fluvastatin
Maltese: Mistoqsijiet u tweġibiet dwar ir-riferiment għal Lescol u l-ismijiet assoċjati Kapsuli li fihom 20 mg jew 40 mg fluvastatina Pilloli b'rilaxx imtawwal li fihom 80 mg fluvastatin
English: The review was carried out under an ‘Article 30' referral1.
Maltese: Din ir-reviżjoni saret skont riferiment għall-‘Artikolu 30'1.
English: The Committee concluded that initial dosing ranging from 20 to 80 mg/day is appropriate.
Maltese: Il-Kumitat ikkonkluda li d-dożi inizjali ta' bejn 20 sa 80 mg/kuljum huma xierqa.
English: Lescol is authorised in the EU via national procedures.
Maltese: Lescol huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Lescol has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Il-Grupp ta' Koordinazzjoni għal Proċeduri Reċiproċi u Deċentralizzati - Umani (CMD(h)) identifika l-ħtieġa li Lescol jiġi armonizzat.
English: The CHMP agreed on two harmonised indications (the diseases for which the medicine may be used): “Dyslipidaemia Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Maltese: Is-CHMP qabel fuq żewġ indikazzjonijiet armonizzati (il-mard li għalih tista' tintuża din il-mediċina): “Dislipidemja Kura tal-iperkolesterolemija primarja jew tad-dislipidemja mħallta, bħala kura miżjuda mad-dieta, meta r-rispons għad-dieta u għall-kuri mhux farmakoloġiċi (eż. eżerċizzju, tnaqqis fil-piż) ma jkunx adegwat.
English: Why was Lescol reviewed?
Maltese: Għaliex ġie rivedut Lescol?
English: Patients with mixed dyslipidaemia have high blood levels of ‘bad' LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good' HDL cholesterol.
Maltese: Pazjenti li jsofru mid-dislipidemja mħallta jkollhom livelli għoljin ta' kolesterol LDL ‘ħażin' u tat-triġliċeridi (tip ta' xaħam), u livelli baxxi ta' kolesterol HDL ‘tajjeb' fiddemm.
English: Lescol is used to treat dyslipidaemia (abnormal levels of fat in the blood), particularly ‘primary hypercholesterolaemia' and ‘mixed dyslipidaemia'.
Maltese: Lescol jintuża fil-kura tad-dislipidemja (livelli anormali ta' xaħam fid-demm), b'mod partikolari ‘liperkolesterolemija primarja' u ‘d-dislipidemja mħallta'.