FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Maltese: L-effetti mhux mixtieqa (Tabella 1) jinsabu mqiegħda f'ordni skont il-frekwenza, bl-aktar frekwenti jitniżżlu l-ewwel, u qed tintuża l-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100, < 1/10); mhux komuni (≥ 1/1,000, < 1/100); rari (≥ 1/10,000, < 1/1,000); rari ħafna (< 1/10,000), inkluż rapporti iżolati.
English: Fluvastatin "Novartis" 40 mg-Kapseln
Maltese: Fluvastatin "Novartis" 40 mgKapseln
English: Fluconazole
Maltese: Il-flukonazol
English: - Phenytoin (a medicine used to treat epilepsy).
Maltese: - Fenitojin (mediċina użata biex tikkura l-epilessija).
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800
Maltese: Medialaan, 40 bus 1 1800
English: • Hypothyroidism.
Maltese: • Ipotirojdiżmu.
English: Lescol/Lescol XL reduces total-C, LDL-C, Apo B, and triglycerides, and increases HDL-C in patients with hypercholesterolaemia and mixed dyslipidaemia.
Maltese: Lescol/Lescol XL inaqqas it-total-C, l-LDL-C, l-Apo B, u t-trigliċeridi, u jżid l-HDL-C f'pazjenti b'iperkolesterolemija u b'dislipidemija mħallta.
English: 140 00 Praha 4 - Nusle, Czech Republic
Maltese: Na Pankráci 1724/129 140 00 Praha 4 - Nusle Ir-Repubblika Ċeka
English: There are multiple, alternative cytochrome P450 (CYP450) pathways for fluvastatin biotransformation and thus fluvastatin metabolism is relatively insensitive to CYP450 inhibition.
Maltese: Ir-rotot tal-bijotrasformazzjoni tal-fluvastatin huma bosta u jinvolvu ċitokromi P450 (CYP450) alternattiv u għaldaqstant il-metaboliżmu tal-fluvastatin huwa relattivament insensittiv għall-inibizzjoni ta' CYP450.
English: - Glibenclamide (a medicine used to treat diabetes).
Maltese: - Glibenklamida (mediċina użata biex tikkura d-dijabete).
English: The hydroxylated metabolites have pharmacological activity but do not circulate systemically.
Maltese: Il-metaboliti idrossillati huma attivi farmakoloġikament imma ma jiċċirkolawx b'mod sistemiku.
English: Immune system disorders Very rare:
Maltese: Disturbi fis-sistema immuni Rari ħafna:
English: Fluvastatin inhibited only the metabolism of compounds that are metabolised by CYP2C9.
Maltese: Il-fluvastatin inibixxa biss il-metaboliżmu tas-sustanzi li jiġu mmetabolizzati b'CYP2C9.
English: In glibenclamide-treated NIDDM patients (n=32), administration of fluvastatin (40 mg twice daily for 14 days) increased the mean Cmax, AUC, and t½ of glibenclamide by approximately 50%, 69%, and 121%, respectively.
Maltese: F'pazjenti bl-NIDDM ikkurati bil-glibenklamida (n=32), l-għoti tal-fluvastatin (40 mg darbtejn kuljum għal 14-il ġurnata) żied il-medja tas-Cmax, tal-AUC, u tat-t½ tal-glibenklamida b'madwar 50%, 69% u 121%, rispettivament.
English: • Alcohol abuse.
Maltese: • Abbuż mill-alkoħol.
English: Box 241
Maltese: FI-02130
English: Oral antidiabetic agents
Maltese: Aġenti orali antidijabetiċi
English: - Fibrates (e.g. gemfibrozil), nicotinic acid or bile acid sequestrants (medicines used to lower bad cholesterol levels).
Maltese: - Fibrati (eż. il-ġemfibrożil), aċidu nikotiniku jew sekwestranti tal-aċidu tal-bili (mediċini wżati sabiex ibaxxu l-livelli tal-kolesterol ħażin).
English: Doctor Zamenhof nº 36 28027 Madrid, Spain
Maltese: Laboratorios Andrómaco, S.A. Doctor Zamenhof nº 36 28027 Madrid
English: Fluvastatin "Novartis" 20 mg-Kapseln
Maltese: Fluvastatin "Novartis" 20 mgKapseln
English: Fluvastatin has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia (for details see section 5.1).
Maltese: Il-fluvastatin ġie investigat biss fi tfal ta' 9 snin u akbar b'iperkolesterolemija familjari eterozigote (ara d-dettalji f'sezzjoni 5.1).
English: Children and adolescents with heterozygous familial hypercholesterolaemia No pharmacokinetic data in children are available.
Maltese: Tfal u adoloxxenti b'iperkolesterolemija familjari eterozigote M'hemmx informazzjoni farmakokinetika fit-tfal.
English: Table 2 Median percent change in lipid parameters from baseline to week 24 Placebo-controlled studies (Lescol) and active-controlled trials (Lescol XL) Total-C TG LDL-C Apo B HDL-C
Maltese: Tabella 2 Bidla fil-medja perċentwali tal-parametri tal-lipidi mil-linja bażi sal-24 ġimgħa Studji kkontrollati bi plaċebo (Lescol) u provi kkontrollati b'mod attiv (Lescol XL)
English: • Sexual dysfunction
Maltese: • Disfunzjoni sesswali
English: - Fluconazole (a medicine used to treat fungal infections).
Maltese: - Flukonazol (mediċina użata biex tikkura l-infezzjonijiet tal-fungu).
English: Other possible side effects - Sleep disturbances, including insomnia and nightmares - Memory loss - Sexual difficulties - Depression - Breathing problems including persistent cough and/or shortness of breath or fever
Maltese: Effetti sekondarji oħrajn possibbli - Disturbi fl-irqad, inkluza insomnja u ħolm ikraħ - Telf ta' memorja - Diffikultajiet sesswali - Dipressjoni - Problemi fit-teħid tan-nifs inkluża sogħla persistenti u/jew nuqqas ta' nifs jew deni
English: ‘The conventional studies, including safety pharmacology, genotoxicity, repeated dose toxicity, carcinogenicity and toxicity on reproduction studies did not indicate other risks for the patient than those expected due to the pharmacological mechanism of action.
Maltese: ‘L-istudji konvenzjonali, inkluż i-farmakoloġija tas-sigurtà, il-ġenetossiċità, it-tossiċità b'doża ripetuta, il-karċinoġeniċità u t-tossiċità fuq studji ta' riproduzzjoni ma indikawx riskji oħrajn għall-pazjent apparti dawk mistennija minħabba l-mekkaniżmu ta' azzjoni farmakoloġika.
English: Lescol/Lescol XL and children/adolescents
Maltese: Lescol/Lescol XL u t-tfal/l-adoloxxenti
English: 1 Data for Lescol from 12 placebo-controlled trials Data for Lescol XL 80 mg tablet from three 24-week controlled trials
Maltese: 1 Informazzjoni dwar Lescol minn 12-il prova kkontrollati bi plaċebo 2 Informazzjoni dwar il-pilloli Lescol XL ta' 80 mg minn tliet provi kkontrollati ta' 24 ġimgħa
English: In a 24-week analysis, daily doses of 20 mg, 40 mg and 80 mg produced dose-related reductions in total-C, LDL-C, Apo B and in triglycerides and increases in HDL-C (see Table 2).
Maltese: F'analiżi ta' 24 ġimgħa, dożi ta' 20 mg, 40 mg u 80 mg kuljum pproduċew tnaqqis fit-total-C, fl-LDL-C, fl-Apo B u fit-trigliċeridi u żieda fl-HDL-C (ara Tabella 2) skont iddoża.
English: Despite the potential that therefore exists for competitive interaction between fluvastatin and compounds that are CYP2C9 substrates, such as diclofenac, phenytoin, tolbutamide and warfarin, clinical data indicate that this interaction is unlikely.
Maltese: Minkejja madanakollu l-eżistenza potenzjali ta' interazzjoni kompetittiva bejn il-fluvastatin u s-sustanzi li huma substrati ta' CYP2C9, bħalma huma d-diklofenak, il-fenitojin, it-tolbutamida u l-warfarina, dati kliniċi juru li din l-interazzjoni ma tantx tidher possibbli.
English: However appropriate wording for the paediatric population were included in the sections agreed during the EU Worksharing procedure; sections 4.2, 4.4, 4.8, 5.1 and 5.2.
Maltese: Madankollu ġie inkluż kliem xieraq għallpopolazzjoni pedjatrika fis-sezzjonijiet li sar qbil fuqhom waqt il-proċedura tal-UE għall-Iskambju ta' Xogħol; sezzjonijiet 4.2, 4.4, 4.8, 5.1 u 5
English: After four weeks of therapy, the median decrease in LDL-C was 38% and at week 24 (endpoint) the median LDL-C decrease was 35%.
Maltese: Wara erba' ġimgħat ta' terapija, it-tnaqqis medju fl-LDL-C kien ta' 38% u fl-24 ġimgħa (endpoint) it-tnaqqis medju fl-LDL-C kien ta' 35%.
English: 90429 Nürnberg, Germany
Maltese: 90429 Nürnberg
English: Phenytoin
Maltese: Il-fenitojin
English: Based on the lack of interaction of fluvastatin with other CYP3A4 substrates, fluvastatin is not expected to interact with grapefruit juice.
Maltese: Skont in-nuqqas ta' interazzjoni ta' fluvastatin ma' sustrati oħra CPY3A4, fluvastatin mhux mistenni li jinteraġixxi mal-meraq tal-grejpfrut.
English: Lescol is efficacious in monotherapy.
Maltese: Lescol huwa effikaċji f'monoterapija.
English: For the secondary CHD prevention indication in patients after transcatheter therapy/PCI, a dose of 80 mg was generally proposed as adequate.
Maltese: Għall-indikazzjoni għall-prevenzjoni ta' CHD sekondarja f'pazjenti wara t-terapija transkatiter/PCI, doża ta' 80 mg kienet ġeneralment proposta bħala adegwata.
English: Following oral administration of 40 mg Lescol, the terminal disposition half-life for fluvastatin is 2.3 ± 0.9 hours.
Maltese: Wara li ngħataw 40 mg Lescol mill-ħalq, il-halflife tad-diżpożizzjoni terminali tal-fluvastatin kienet ta' 2.3 ± 0.9 sigħat.
English: • Primary hypercholesterolaemia and mixed dyslipidaemia Starting dose recommendation
Maltese: • Iperkolesterolemija primarja u dislipidemija mħallta
English: The CHMP agreed that the proposed starting dose of 40 mg in patients requiring LDL-C reductions of ≥25% is justified by the clinical data provided.
Maltese: Is-CHMP qabel li d-doża inizjali proposta ta' 40 mg f'pazjenti li jeħtieġu tnaqqis LDL-C ta' ≥25% hija iġġustifikata bid-dejta klinika pprovduta.
English: Children and adolescents with heterozygous familial hypercholesterolaemia The safety profile of fluvastatin in children and adolescents with heterozygous familial hypercholesterolaemia assessed in 114 patients aged 9 to17 years treated in two open-label non-comparative clinical trials was similar to the one observed in adults.
Maltese: Tfal u adoloxxenti b'iperkolesterolemija familjari eterozigote Il-profil ta' sigurtà tal-fluvastatin fit-tfal u l-adoloxxenti b'iperkolesterolemija familjari eterozigote evalwat f'114-il pazjent ta' bejn 9 snin u 17-il sena kkurati f'żewġ provi kliniċi open-label mhux komparattivi kien jixbah lil dak osservat fl-adulti.
English: Fluvastatin treatment slowed the progression of coronary atherosclerosis lesions by 0.072 mm (95% confidence intervals for treatment difference from −0.1222 to −0.022 mm) over 2.5 years as measured by change in minimum lumen diameter (fluvastatin −0.028 mm vs. placebo −0.100 mm).
Maltese: Il-kura bil-fluvastatin naqqset il-progressjoni tal-feriti tal-aterosklerożi koronarja b'0.072 mm (b'intervalli ta' kunfidenza ta' 95% fejn tidħol id-differenza fil-kura minn -0.1222 għal -0.
English: • Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4)
Maltese: • Kazijiet eċċezzjonli ta' mard interstizzjali tal-pulmun, speċjalment ma' terapija fit-tul (ara sezzjoni 4.4)
English: The second study enrolled 85 male and female patients, 10 to 16 years of age, who had an LDL-C > 190 mg/dl (equivalent to 4.9 mmol/l) or LDL-C > 160 mg/dl (equivalent to 4.1 mmol/l) and one or more risk factors for coronary heart disease, or LDL-C > 160 mg/dl (equivalent to 4.1 mmol/l) and a proven LDLreceptor defect.
Maltese: It-tieni studju kien jinvolvi 85 pazjent raġel u mara, ta' bejn 10 snin u 16-il sena, li kellhom l-LDL-C > 190 mg/dl (ekwivalenti għal 4.9 mmol/l) jew l-LDL-C > 160 mg/dl (ekwivalenti għal 4.1 mmol/l) kif ukoll fattur wieħed jew aktar ta' riskju ta' mard koronarju tal-qalb, jew li kellhom LDL-C > 160 mg/dl (ekwivalenti għal 4.1 mmol/l) u diffett ippruvat fir-riċettur tal-LDL.
English: The absolute bioavailability assessed from systemic blood concentrations is 24%.
Maltese: Il-bijodisponibbiltà assoluta mkejla minn konċentrazzjonijiet sistemiċi tad-demm hi ta' 24%.
English: Myopathy has rarely been reported with fluvastatin.
Maltese: Mijopatija kient irrappurtata b'mod rari bil-fluvastatin.
English: Lescol, a fully synthetic cholesterol-lowering agent, is a competitive inhibitor of HMG-CoA reductase, which is responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.
Maltese: Lescol, sustanza sintetika għal kollox li tbaxxi l-kolesterol, huwa inibitur reductase kompetittiv ta' HMG-CoA, li huwa responsabbli għal konverżjoni ta' HMG-CoA għal mevalonate, prekursur talisteroli, inkluż il-kolesterol.
English: Uncommon: affects 1 to 10 users in 1,000
Maltese: Mhux komuni: jaffetwaw bejn 1 sa 10 pazjenti minn f'1,000
English: Lescol/Lescol XL contains the active fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood.
Maltese: Lescol/Lescol XL fihom is-sustanza attiva fluvastatin sodium li tagħmel parti minn grupp ta' mediċini magħrufa bħala statini, li huma mediċini li jbaxxu l-lipidi: huma jnaqqsu ix-xaħam (lipidi) mid-demm tiegħek.
English: The risk of myopathy has been reported to be increased in patients receiving immunosuppressive agents (including ciclosporin), fibrates, nicotinic acid or erythromycin together with other HMG-CoA reductase inhibitors.
Maltese: Kien irrappurtat li żdied ir-riskju ta' mijopatija f'pazjenti mogħtija aġenti immunosuppressivi (fosthom iċ-ċiklosporina), il-fibrati, l-aċidu nikotiniku jew l-eritromiċin flimkien ma' inibituri oħrajn ta' HMG-CoA reductase.
English: Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.'
Maltese: Lescol/Lescol XL ġie investigat biss fi tfal ta' 9 snin u akbar b'kolesterolemija eteroziga familjali.'
English: This result was independent of baseline total cholesterol levels.
Maltese: Ir-riżultat kien indipendenti mil-livelli ta' kolesterol totali tal-linja bażi.
English: Rare: affects 1 to 10 users in 10,000
Maltese: Rari: jaffetwaw bejn 1 sa 10 pazjenti f'kull 10, 000
English: A summary of the clinical trial data from the Lipoprotein and Coronary Atherosclerosis Study (LCAS) has been proposed by the MAH, including a statement that the significance of angiographic findings was not known.
Maltese: Ġie propost sommarju tad-dejta tal-prova klinika mill-Istudju tal-Lipoproteina u Aterosklerożi Koronarja (LCAS) mill-MAH, inkluż dikjarazzjoni li s-sinifikat tas-sejbiet anġjografiċi ma kienx magħruf.
English: The recommended dosing range is 20 to 80 mg/day.
Maltese: Il-medda ta' dożi rrakkomandati hija bejn 20 u 80 mg/kuljum.
English: 8 , Quinta de Beloura 2710-444, Sintra, Portugal
Maltese: Rua do Centro Empresarial, Edif. 8 Quinta de Beloura 2710-444
English: The CHMP was of the opinion that the data submitted by the MAH intended to support the indication “Lescol/Lescol XL is indicated to slow the progression of coronary atherosclerosis in adults with primary hypercholesterolaemia and coronary heart disease” was not clinically meaningful and therefore a positive benefit/risk could not be established.
Maltese: Is-CHMP kien tal-opinjoni li d-dejta sottomessa mill-MAH bl-intenzjoni li ssostni l-indikazzjoni “Lescol/Lescol XL hu indikat biex inaqqas il-progressjoni ta' aterosklerożi koronarja f'adulti b'iperkolesterolemija primarja u b'mard tal-qalb koronarju” ma kinitx klinikament sinifikanti u għalhekk ma setax jiġi stabbilit benefiċċju/riskju pożittiv.
English: Fluvastatin, a fully synthetic cholesterol-lowering agent, is a competitive inhibitor of HMG-CoA reductase, which is responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol.
Maltese: Il-fluvastatin, aġent għal kollox sintetiku li jbaxxi l-kolesterol, huwa inibitur kompetittiv ta' HMCCoA reductase, li huwa responsabbli mill-bidla ta' HMG-CoA f'mevalonat, prekursur tal-isteroli, inkluż tal-kolesterol.
English: Based on clinical observations, liver function tests are already recommended (see section 4.4).
Maltese: Fuq bażi ta' osservazzjonijiet kliniċi, testijiet tal-funzjoni talfwied diġà ġew irrakkomandati (ara sezzjoni 4.4).
English: Fluvastatin is absorbed rapidly and completely (98%) after oral administration of a solution to fasted volunteers.
Maltese: Il-fluvastatin jiġi assorbit malajr u għal kollox (98%) wara li jingħata bħala soluzzjoni mill-ħalq lil voluntiera sajmin.
English: In 12 placebo-controlled studies in patients with Type IIa or IIb hyperlipoproteinaemia, Lescol alone was administered to 1,621 patients in daily dose regimens of 20 mg, 40 mg and 80 mg (40 mg twice daily) for at least 6 weeks duration.
Maltese: Fi 12-il studju kkontrollati bi plaċebo b'pazjenti b'iperlipoproteinemija tat-Tip IIa jew IIb, Lescol waħdu ngħata lil 1,621 pazjent f'dożi fissi ta' 20 mg, 40 mg u 80 mg (40 mg darbtejn kuljum) kuljum għal mill-anqas 6 ġimgħat.
English: The CHMP agreed with the following wording proposed by the MAH for this indication: ‘Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).'
Maltese: Is-CHMP qabel mal-kliem segwenti proposti mill-MAH għal din l-indikazzjoni: ‘Prevenzjoni sekondarja tal-avvenimenti kardijaċi maġġuri f'adulti b'mard koronarju tal-qalb wara interventi koronarji minn ġol-ġilda (ara sezzjoni 5.1).'
English: All patients were started on Lescol capsules 20 mg daily with dose adjustments every 6 weeks to 40 mg daily then 80 mg daily (40 mg twice daily) to achieve an LDL-C goal of 96.7 to 123.7 mg/dl (2.5 mmol/l to 3.2 mmol/l).
Maltese: Il-pazjenti kollha ngħataw kapsuli Lescol ta' 20 mg kuljum b'aġġustament taddoża kull 6 ġimgħat sa 40 mg kuljum u wara sa 80 mg kuljum (40 mg darbtejn kuljum) sabiex jilħqu lgħan ta' LDL-C ta' bejn 96.7 u 123.7 mg/dl (bejn 2.5 mmol/l u 3.2 mmol/l).
English: The mean baseline LDL-C was 225 mg/dl equivalent to 5,8 mmol/l (range: 148-343 mg/dl equivalent to 3.8-8.9 mmol/l).
Maltese: Il-linja bażi medja tal-LDL-C kienet ta' 225 mg/dl ekwivalenti għal 5.8 mmol/l (firxa: 148-343 mg/dl ekwivalenti għal 3.8-8.9 mmol/l).
English: Lescol/Lescol XL is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases (see sections 4.3, 4.4 and 5.2).
Maltese: Lescol/Lescol XL huwa kontraindikat f'pazjenti b'mard attiv tal-fwied, jew b'livelli għoljin b'mod persistenti, jew bla raġuni, tat-transaminasi fis-serum (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: In the Lescol Intervention Prevention Study (LIPS), the effect of fluvastatin on major adverse cardiac events (MACE; i.e. cardiac death, non-fatal myocardial infarction and coronary revascularisation) was assessed in patients with coronary heart disease who had first successful percutaneous coronary intervention.
Maltese: Waqt il-Lescol Intervention Prevention Study (LIPS), kien evalwat l-effett tal-fluvastatin fuq episodji kardijaċi ewlenin mhux mixtieqa (MACE, jiġifieri mewta kardijaka, infart mijokardijaku mhux fatali u rivaskularizzazzjoni koronarja) f'pazjenti b'mard koronarju tal-qalb li l-ewwel kellhom intervent koronarju perkutanju li rnexxa.
English: Each Lescol 40 mg capsule contains 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid.
Maltese: Kull kapsula ta' 40 mg Lescol fiha 42.12 mg fluvastatin sodiku ekwivalenti għal 40 mg fluvastatin aċidu liberu.
English: In this randomised, double-blind, controlled clinical study, 429 patients were treated with either fluvastatin 40 mg/day or placebo.
Maltese: F'dan l-istudju kliniku randomizzat, double-blind u kkontrollat, 429 pazjent kienu kkurati jew b'40 mg fluvastatin kuljum jew bi plaċebo.
English: • Previous history of muscular toxicity with a statin or fibrate.
Maltese: • Storja minn qabel ta' tossiċità muskolari minħabba statin jew fibrat.
English: Following administration of 3H-fluvastatin to healthy volunteers, excretion of radioactivity is about 6% in the urine and 93% in the faeces, and fluvastatin accounts for less than 2% of the total radioactivity excreted.
Maltese: Wara li l-fluvastatin-3H ingħata lil voluntiera b'saħħithom, it-tneħħija tar-radjuattività kienet ta' madwar 6% fl-urina u ta' 93% fl-ippurgar, filwaqt li anqas minn 2% tar-radjuattività totali mneħħija kienet minħabba l-fluvastatin.
English: A variety of changes were identified in toxicity studies that are common to HMG-CoA reductase inhibitors.
Maltese: Varjetà ta' tibdiliet kienet identifikata fi studji dwar effetti tossiċi li huma komuni għal impedituri ta' HMG-CoA reductase.
English: The CHMP agreed with the following wording for a flexible initial dosing of 40-80mg: ‘The recommended dosing range is 20 to 80 mg/day.
Maltese: Is-CHMP qabel mal-kliem segwenti għal doża inizjali flessibbli ta' 40-80 mg: ‘Il-firxa tad-doża rrakkomandata hija ta' 20 sa 80 mg/jum.
English: The Product Information (PI) has also been updated according to the CHMP PhVWP Report on HMG CoA reductase inhibitors to include the following adverse events that have been reported with some statins: sleep disturbances, including insomnia and nightmares, memory loss, sexual dysfunction, depression, exceptional cases of interstitial lung disease,
Maltese: Il-Fuljett ta' Tagħrif (PI) ġie aġġornat ukoll skont ir-Rapport tal-PhVWP tas-CHMP dwar l-inibituri reductase ta' HMG CoA biex jinkludi l-episodji avversi segwenti li kienu rrapportati b'xi statins: disturbi fl-irqad, inkluż insomnja u ħmar il-lejl, telf ta' memorja, disfunzjoni sesswali, depressjoni, każijiet eċċezzjonali ta' mard interstizjali tal-pulmun, b'mod speċjali b'terapija fit-tul.
English: The study included male and female patients (18 to 80 years old) and with baseline total-C levels ranging from 3.5 to 7.0 mmol/l (135 to 270 mg/dl).
Maltese: L-istudju kien jinkludi pazjenti rġiel u nisa (ta' bejn 18 u 80 sena) u bil-livelli tat-total-C fil-linja bażi ta' bejn 3.5 u 7.0 mmol/l (bejn 135 u 270 mg/dl).
English: Dyslipidaemia
Maltese: IPPREŻENTATI
English: I-21040 Origgio / VA Italy
Maltese: Origgio / VA L-Italja
English: Based on the Cox regression analysis the risk ratio for MACE was estimated at 0.78, equivalent to a statistically significant 22% reduction in the risk of MACE for patients treated in the Lescol group compared to the placebo group.
Maltese: Skont l-analiżi tarrigressjoni Cox, il-proporzjon ta' riskju għal MACE kien stmat għal 0.78, ekwivalenti għal tnaqqis sinifikanti għall-istatistika ta' 22% fir-riskju ta' MACE għal pazjenti ikkurati fil-grupp tal-Lescol meta mqabbla mal-grupp tal-plaċebo.
English: The mean achieved LDL-C was 159 mg/dl equivalent to 4.1 mmol/l (range: 90-295 mg/dl equivalent to 2.3-7.6 mmol/l).
Maltese: Il-medja milħuqa tal-LDL-C kienet ta' 159 mg/dl ekwivalenti għal 4.1 mmol/l (firxa: 90-295 mg/dl ekwivalenti għal 2.3-7.6 mmol/l).
English: From an efficacy perspective the 80 mg dose provided reliable LDL-C lowering of at least 30% vs baseline at 24 weeks.
Maltese: Minn perspettiva ta' effikaċja, id-doża ta' 80 mg ipprovdiet tnaqqis LDL-C affidabbli ta' almenu 30% vs il-linja bażi ta' 24 ġimgħa.
English: Therefore, Lescol/Lescol XL is contraindicated during pregnancy (see section 4.3).
Maltese: Għaldaqstant, Lescol/Lescol XL m'għandux jingħata waqt it-tqala (ara ssezzjoni 4.3).
English: Czech Republic Novartis, s.r.o.
Maltese: Novartis, s.r.o.
English: Significant increases in HDL-C were also observed.
Maltese: Kienu osservati wkoll żidiet sinifikanti fl-HDL-C.
English: The MAH Novartis completed the EU Work Sharing Project on paediatric wording on 24 July 2007.
Maltese: Il-MAH Novartis lesta l-Proġett għall-Iskambju ta' Xogħol tal-UE dwar it-test pedjatriku fl-24 ta' Lulju 2007.
English: Thrombocytopenia
Maltese: Iċ-ċiklosporina
English: 20 mg and 40 mg capsules Member State
Maltese: Kapsuli ta' 20 mg u 40 mg Stat Membru
English: Administration of fluvastatin to healthy volunteers pre-treated with fluconazole (CYP 2C9 inhibitor) resulted in an increase in the exposure and peak concentration of fluvastatin by about 84% and 44%.
Maltese: Meta l-fluvastatin ingħata lil voluntiera b'saħħithom li kienu kkurati minn qabel bil-flukonazol (inibitur ta' CYP 2C9) wassal biex ikun hemm żieda fl-espożizzjoni u fil-konċentrazzjoni tal-quċċata tal-fluvastatin b'madwar 84% u 44%.
English: In the second study (in pubertal or postpubertal girls and boys), Lescol 20 to 80 mg daily doses decreased plasma levels of total-C and LDL-C by 22% and 28%, respectively.
Maltese: Fit-tieni studju (fost subien u bniet li laħqu l-età tal-pubertà jew qabżuha), dożi ta' bejn 20 u 80 mg Lescol kuljum naqqsu l-livelli tal-plażma fit-total-C u fl-LDL-C b'22% u b'28%, rispettivament.