FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the heterogeneity in the presentation of the clinical trial data for dyslipidaemia across the various Member States, a concise approach including data on Lescol IR from the pooled placebo-controlled studies and data from the Lescol XL development program has been proposed.
Maltese: Minħabba l-eteroġeneità fil-preżentazzjoni tad-dejta tal-prova klinika għal dislipidemija mad-diversi Stati Membri kollha, ġie propost approċċ konċiż inkluż id-dejta dwar Lescol IR mill-istudji ikkontrollati bi plaċebo miġbura flimkien u d-dejta mill-programm ta' żvilupp ta' Lescol XL.
English: Section 5.2 - Pharmacokinetic properties The CHMP agreed with the wording proposed by the MAH.
Maltese: Sezzjoni 5.2 - Tagħrif farmakokinetiku Is-CHMP qabel mal-kliem propost mill-MAH:
English: The plasma clearance (CL/f) for fluvastatin in man is calculated to be 1.8 ± 0.8 l/min.
Maltese: Huwa kkalkulat li t-tneħħija tal-plażma (CL/f) fil-fluvastatin f'raġel hi ta' 1.8 ± 0.8 l/min.
English: Novartis Pharma GmbH, Brunner Strasse 59
Maltese: L-Awstrija Novartis Pharma GmbH Brunner Strasse 59
English: The statement that isolated cases of myopathy have been reported post-marketing for concomitant administration of fluvastatin with ciclosporin and the statement related to concomitant administration of fluvastatin and colchicines has been included in the MAH's proposal and agreed by the CHMP.
Maltese: Id-dikjarazzjoni li każijiet iżolati ta' mijopatija ġew irrapportati wara t-tqegħid fis-suq għal amministrazzjoni fl-istess ħin ta' fluvastatin ma' ciclosporin u d-dikjarazzjoni relatata malamministrazzjoni fl-istess ħin ta' fluvastatin u colchicines ġew inklużi fil-proposta tal-MAH u sar qbil fuqhom mis-CHMP.
English: Lescol MR 80 mg - Filmtabletten
Maltese: Lescol MR 80 mg - Filmtabletten80 mg Pillola miksija b'rita
English: In the first study (in prepubertal boys), Lescol 20 to 80 mg daily doses decreased plasma levels of total-C and LDL-C by 21% and 27%, respectively.
Maltese: Fl-ewwel studju (fost subien li ma laħqux l-età tal-pubertà), dożi ta' bejn 20 u 80 mg Lescol kuljum naqqsu l-livelli tal-plażma fit-total-C u fl-LDL-C b'21% u b'27%, rispettivament.
English: Considering the possibility of teratogenicity with statins as a class, the benefit risk for the use in pregnancy has been considered as negative for statins including fluvastatin and the contraindication in pregnancy justified.
Maltese: Meta wieħed jikkunsidra l-possibilità ta' teratoġeniċità bl-istatins bħala klassi, ilbenefiċċju/riskju tal-użu ta' statins inkluż fluvastatin fit-tqala kien meqjus bħala negattiv u lkontraindikazzjoni fit-tqala iġġustifikata.
English: Concomitant administration of fluvastatin with the potent cytochrome P450 (CYP) 3A4 inhibitors itraconazole and erythromycin has minimal effects on the bioavailability of fluvastatin.
Maltese: L-għoti flimkien tal-fluvastatin mal-inibituri taċ-ċitokromu qawwi P450 (CYP) 3A4 itrakonazol u eritromiċin ftit li xejn għandu effett fuq il-bijodisponibbiltà tal-fluvastatin.
English: Blood and lymphatic system disorders Very rare:
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari ħafna:
English: The mean achieved LDL-C was 161 mg/dl equivalent to 4.2 mmol/l (range: 74-336 mg/dl equivalent 1.9-8.7 mmol/l).
Maltese: Il-medja milħuqa tal-LDL-C kienet ta' 161 mg/dl ekwivalenti għal 4.2 mmol/l (firxa: 74-336 mg/dl ekwivalenti għal 1.9-8.7 mmol/l).
English: The secondary prevention indication in patients after PCI is based on the Lescol Intervention Prevention Study (LIPS).
Maltese: L-indikazzjoni ta' prevenzjoni sekondarja f'pazjenti wara l-PCI hija bbażata fuq l-Istudju dwar ilPrevenzjoni b'Intervent ta' Lescol (LIPS).
English: LIPS (study LES-EUR-01) was conducted to determine if fluvastatin therapy reduced the long-term risk of MACE (i.e. cardiac death, non-fatal myocardial infarction (MI) and coronary revascularisation) in CHD patients after a successful PCI.
Maltese: Sar LIPS (studju LES-EUR-01) biex jiġi stabbilit jekk itterapija fluvastatin naqqsitx ir-riskju ta' MACE (jiġifieri mewt kardijaka, infart mijokardijaku mhux fatali (MI) u rivaskularizzazzjoni koronarja) għal terminu twil f'pazjenti b'CHI wara PCI b'suċċess.
English: Novartis Pharma B.V. P.O.
Maltese: Novartis Pharma B.V. P.O. Box 241
English: The mean baseline LDL-C was 226 mg/dl equivalent to 5.8 mmol/l (range: 137-354 mg/dl equivalent to 3.6-9.2 mmol/l).
Maltese: Il-linja bażi medja tal-LDL-C kienet ta' 226 mg/dl ekwivalenti għal 5.8 mmol/l (firxa: 137-354 mg/dl ekwivalenti għal 3.6-9.2 mmol/l).
English: Hypersensitivity reactions such as rash, urticaria
Maltese: Reazzjonijiet ta' sensittività eċċessiva bħal raxx, urtikarja
English: • Memory loss
Maltese: • Telf ta' memorja
English: Concomitant administration of fluvastatin with bezafibrate, gemfibrozil, ciprofibrate or niacin (nicotinic acid) has no clinically relevant effect on the bioavailability of fluvastatin or the other lipid-lowering agent.
Maltese: L-għoti flimkien tal-fluvastatin mal-bezafibrat, il-ġemfibrozil, iċ-ċiprofibrat jew in-nijaċin (l-aċidu nikotiniku) ma għandu l-ebda effett relevanti klinikament fuq il-bijodisponibbiltà tal-fluvastatin jew fuq l-aġent l-ieħor li jbaxxi l-lipidi.
English: • Secondary prevention of major cardiac events in adults with coronary heart disease (CHD)
Maltese: • Prevenzjoni sekondarja tal-avvenimenti kardijaċi maġġuri f'adulti b'mard koronarju tal qalb (CHD) wara interventi koronarji minn ġol-ġilda (PCI)
English: • in patients with active liver disease, or unexplained, persistent elevations in serum transaminases (see sections 4.2, 4.4 and 4.8).
Maltese: • f'pazjenti b'mard attiv tal-fwied, jew b'livelli għoljin b'mod persistenti, jew bla raġuni, tat transaminasi fis-serum (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Lescol IR (Lescol immediate release) 20 mg and 40 mg capsules were first registered in 1993.
Maltese: Lescol IR (Lescol li jerħu l-mediċina malajr) 20 mg u 40 mg ġew reġistrati għall-ewwel darba fl-1993.
English: • Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
Maltese: • Il-prevenzjoni sekondarja tal-avvenimenti kardijaċi kbar f'adulti b'mard tal-qalb koronarju wara interventi koronarji minn ġol-ġilda (ara sezzjoni 5.1).
English: An analysis from the pooled clinical trial databases of Lescol IR or Lescol XL registration studies provided by the MAH showed that the likelihood of achieving LDL reductions of ≥25% was modest with a 20 mg daily dosage of fluvastatin.
Maltese: Analiżi middatabases tal-provi kliniċi miġbura flimkien tal-istudji ta' reġistrazzjoni ta' Lescol IR jew Lescol XL mill-MAH, uriet li l-probabilità li jinkiseb tnaqqis LDL ta' ≥25% b'doża ta' fluvastatin ta' 20 mg kuljum kienet modesta.
English: Given as a single daily dose of 80 mg, Lescol XL significantly reduced total-C, LDL-C, triglycerides (TG) and Apo B (see Table 2).
Maltese: Meta Lescol XL ingħata bħala doża waħda ta' 80 mg kuljum, dan naqqas b'mod sinifikanti t-total-C, l-LDL-C, ittrigliċeridi (TG) u l-Apo B (ara Tabella 2).
English: Administration of fluvastatin to healthy volunteers pre-treated with rifampicin (rifampin) resulted in a reduction of the bioavailability of fluvastatin by about 50%.
Maltese: Meta l-fluvastatin ingħata lil voluntiera b'saħħithom ikkurati minn qabel bir-rifampiċin (ir-rifampin), dan wassal għal tnaqqis fil-bijodisponibbiltà tal-fluvastatin b'madwar 50%.
English: No clinical data is available for Lescol in patients with homozygous familial hypercholesterolaemia (HoFH) and is stated in this section.
Maltese: M'hemm l-ebda dejta klinika disponibbli għal Lescol f'pazjenti b'iperkolesterolemija omoziga familjali(HoFH) u dan huwa ddikjarat f'din is-sezzjoni.
English: The major components circulating in the blood are fluvastatin and the pharmacologically inactive N-desisopropyl-propionic acid metabolite.
Maltese: Il-komponenti ewlenin li jiċċirkolaw fiddemm huma l-fluvastatin u l-metabolit tal-aċidu N-desisopropil-propjoniku mhux attiv farmakoloġikament.
English: Largo Boccioni, 1, 21040 Origgio (VA), Italy
Maltese: Largo Boccioni, 1 21040
English: If a patient becomes pregnant while taking Lescol/Lescol XL, therapy should be discontinued.
Maltese: Jekk pazjenta toħroġ tqila waqt li qed tieħu Lescol/Lescol XL, għandha titwaqqaf it-terapija.
English: In the LIPS study which was the basis for this indication, the 80 mg daily dose of fluvastatin (i.e., Lescol IR 40 mg BID) was used as starting dose.
Maltese: Fl-istudju LIPS li kien il-bażi għal din lindikazzjoni, id-doża ta' 80 mg kuljum ta' fluvastatin (jiġifieri Lescol IR 40 mg BID) intużat bħala ddoża inizjali.
English: Both Lescol capsules(40 mg fluvastatin) and Lescol XL tablets (80 mg fluvastatin) had no effect on the bioavailability of ciclosporin when co-administered.
Maltese: Kemm il-kapsuli Lescol (40 mg fluvastatin) kif ukoll il-pilloli Lescol XL (80 mg fluvastatin) ma kellhom l-ebda effett fuq il-bijodisponibbiltà ta' ċiklosporina meta meħuda flimkien.
English: • Primary hypercholesterolaemia and mixed dyslipidaemia The CHMP agreed with the MAH that additional statements on the exclusion of certain lipoprotein disorders (e.g homozygous variants of familial hypercholesterolaemia and other Fredrickson types with predominant hypertriglyceridemia, or secondary forms of hypercholesterolaemia) are not required in the indication section.
Maltese: Is-CHMP qabel mal-MAH li mhumiex meħtieġa dikjarazzjonijiet dwar l-esklużjoni ta' ċerti disturbi ta' liporoteina (eż. varjanti omozigoti tal-iperkolesterolemija familjali u tipi ta' Fredrickson oħrajn b'ipertrigliċeridimja predominanti, jew b'forom sekondarji ta' iperkolesterolemija) fis-sezzjoni talindikazzjoni.
English: Lescol 20 mg, 40 mg are hard gelatine capsules and Lescol 80 mg is a modified release film coated tablet.
Maltese: Lescol 20 mg, 40 mg huma kapsuli tal-ġelatina iebsin u Lescol 80 mg huma pilloli b'rita li jerħu l-mediċina b'mod modifikat.
English: Each Lescol XL 80 mg tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Maltese: 24 mg fluvastatin sodiku ekwivalenti għal 80 mg fluvastatin aċidu liberu.
English: Impaired kidney function
Maltese: Indeboliment fil-funzjoni tal-kliewi
English: Histamine H2-receptor antagonists and proton pump inhibitors Concomitant administration of fluvastatin with cimetidine, ranitidine or omeprazole results in an increase in the bioavailability of fluvastatin, which, however, is of no clinical relevance.
Maltese: Antagonisti tar-riċettur-H2 tal-istamina u inibituri tal-pompa tal-proton L-għoti flimkien tal-fluvastatin maċ-ċimetidina, mar-ranitidin jew mal-omeprazol iwassal għal żieda fil-bijodisponibbiltà tal-fluvastatin, li, madanakollu, m'għandhiex relevanza klinika.
English: NAME OF THE MEDICINAL PRODUCT Lescol and associated names (see Annex I) 20 mg capsules, hard Lescol and associated names (see Annex I) 40 mg capsules, hard Lescol XL and associated names (see Annex I) 80 mg prolonged-release tablets Fluvastatin
Maltese: Lescol u ismijiet assoċjati miegħu (ara Anness I) 20 mg kapsuli, iebsa Lescol u ismijiet assoċjati miegħu (ara Anness I) 40 mg kapsuli, iebsa Lescol XL u ismijiet assoċjati miegħu (ara Anness 1) 80 mg pilloli li jerħu l-mediċina bil-mod [Ara Anness I - Biex timtela mill-pajjiż partikolari] Fluvastatin
English: Based on the recommendation given by the CHMP, the following wording proposed was agreed: ‘Renal Impairment
Maltese: Skont ir-rakkomandazzjoni mogħtija mis-CHMP, sar qbil fuq l-għażla tal-kliem segwenti: ‘Indeboliment renali
English: Active substance: fluvastatin (as fluvastatin sodium)
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI [Biex timtela mill-pajjiż partikolari]
English: Very rare: affects less than 1 user in 10,000
Maltese: Rari ħafna: jaffetwaw inqas minn pazjent wieħed f'kull 10,000
English: The recommended starting dose is one 20 mg Lescol capsule.
Maltese: Id-doża inizjali rrakkomandata hija kapsula waħda ta' Lescol 20 mg.
English: The use of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents has not been investigated.
Maltese: L-użu ta' fluvastatin flimkien ma' aċidu nikotiniku, cholestyramine, jew fibrati fit-tfal u ladolexxenti ma ġiex investigat.
English: The first study enrolled 29 pre-pubertal boys, 9-12 years of age, who had an LDL-C level > 90th percentile for age and one parent with primary hypercholesterolaemia and either a family history of premature ischaemic heart disease or tendon xanthomas.
Maltese: L-ewwel studju kien jinvolvi 29 tifel fl-età ta' qabel il-pubertà, ta' bejn 9 snin u 12-il sena, li kellhom il-livell tal-LDL-C fid- 90 percentile għall-età u ġenitur wieħed b'iperkolesterolemija primarja kif ukoll bi storja fil-familja ta' iskemija mijokardijaka prematura jew ta' tendon xanthomas.
English: The data on LDL-C lowering at different time points based on the pooled efficacy analysis from the Lescol XL registration program supports the following recommendation:
Maltese: Id-dejta fuq it-tnaqqis tal-LDL-C f'punti ta' ħin differenti ibbażata fuq l-analiżi miġbura flimkien dwar l-effikaċja mill-programm ta' reġistrazzjoni ta' Lescol XL, tappoġġja r-rakkomandazzjoni segwenti:
English: The following wording proposed by the MAH was considered to be acceptable for the CHMP: ‘Lescol is efficacious in monotherapy.
Maltese: Il-kliem segwenti propost mill-MAH kien meqjus bħala aċċettabbli mis-CHMP. ‘Lescol huwa effikaċi f'monoterapija.
English: The CHMP agreed with the following wording proposed by the MAH: ‘In patients with coronary heart disease after percutaneous coronary interventions the appropriate daily dose is 80 mg.'
Maltese: Is-CHMP qabel mal-kliem segwenti proposti mill-MAH: ‘F'pazjenti b'mard tal-qalb koronarju wara l-interventi koronarji minn ġol-ġilda, id-doża adegwata ta' kuljum hi ta' 80 mg.'
English: − Lescol/Lescol XL is a medicine used to treat raised levels of fats in the blood in adults, in particular total cholesterol and so called “bad” or LDL cholesterol, which is associated with an increased risk of heart disease and stroke.
Maltese: − Lescol/Lescol XL hija mediċina li tintuża sabiex tikkura livelli għolja ta' xaħam fid-demm fl-adulti, b'mod partikolari l-kolesterol totali u dak imsejjaħ “ħażin” jew kolesterol LDL, li huwa assoċjat ma riskju ogħla ta' mard tal-qalb u puplesija
English: Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.
Maltese: Lescol/Lescol XL ġie biss investigat fi tfal ta' 9 snin jew iktar b'iperkolesterolemija familjari eterozigote.
English: Each Lescol 20 mg capsule contains 21.06 mg fluvastatin sodium equivalent to 20 mg fluvastatin free acid.
Maltese: Sustanza attiva: fluvastatin (bħala fluvastatin sodiku) Kull kapsula Lescol fiha 21.06 mg fluvastatin sodiku ekwivalenti għal 20 mg fluvastatin aċidu liberu jew
English: After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Lescol/Lescol XL.
Maltese: Wara li tieħu r- reżin, eż. il-kolestiramina (użata primarjament sabiex titratta kolesterol għoli) stenna mill-inqas 4 sigħat qabel ma tieħu Lescol/Lescol XL.
English: The undesirable effects currently listed are consistently represented in the SPCs of the EU Member States, except for anaphylactic reaction, which was recently included.
Maltese: L-effetti mhux mixtieqa elenkati attwalment huma rrappreżentati b'mod konsistenti fl-SPCs tal-Istati Membri tal-UE, barra r-reazzjoni anafilattika, li ġiet inkluża reċentement.
English: In patients with unexplained diffuse myalgias, muscle tenderness or muscle weakness, and/or marked elevation of creatine kinase (CK) values, myopathy, myositis or rhabdomyolysis have to be considered.
Maltese: F'pazjenti li bla raġuni jkollhom mijalġa mifruxa, sensibbiltà muskolari jew indebboliment muskolari, u/jew żieda f'daqqa fil-valuri tal-kreatina kinasi (CK), għandhom jitqiesu lmijopatija, il-mijositi jew ir-rabdomijoliżi.
English: In healthy volunteers, the use of fluvastatin and warfarin (single dose) did not adversely influence warfarin plasma levels and prothrombin times compared to warfarin alone.
Maltese: F'voluntiera b'saħħithom, l-użu tal-fluvastatin u l-warfarina (doża waħda) ma influwenzax b'mod mhux mixtieq il-livelli tal-plażma fil-warfarina u ż-żmien tal-protrombina meta mqabbel malwarfarina waħedha.
English: Concomitant treatment with other lipid modifying drugs The MAH submitted published data to support the efficacy and safety of Lescol/Lescol XL in combination with nicotinic acid, cholestyramine, or fibrates.
Maltese: Trattament konkomitanti ma' drogi oħra li jimmodifikaw il-lipidi Il-MAH issottometta dejta ppubblikata biex isostni l-effikaċja u s-sigurtà ta' Lescol/Lescol XL flimkien ma' aċidu nikotiniku, cholestyramine, jew fibrati.
English: Myotoxicity, including muscle pain and weakness and rhabdomyolysis, has been reported in isolated cases with concomitant administration of colchicines.
Maltese: L-mijotossiċità, inkluż uġigħ u indebboliment muskolari u r-rabdomijolożi, ġiet irrapurtata f'każijiet iżolati meta ngħata flimkien mal-kolkiċini.
English: Lescol Exel 80 mg prolonged-release tablet
Maltese: Lescol Exel 80 mg prolongedrelease tablet
English: 6.1 List of excipients [To be completed Nationally]
Maltese: [Biex timtela mill-pajjiż partikolari] 6.2 Inkompatibilitajiet
English: The CHMP agreed with the following wording: ‘Children and adolescents with heterozygous familial hypercholesterolaemia ‘Prior to initiating treatment with Lescol/Lescol XL in children and adolescents aged 9 years and older with heterozygous familial hypercholesterolaemia, the patient should be placed on a standard cholesterollowering diet, and continued during treatment.
Maltese: Is-CHMP qabel mal-kliem segwenti: ‘Tfal u adolexxenti b'iperkolesterolemija eteroziga familjali ‘Qabel ma jinbeda t-trattament b'Lescol/Lescol XL fi tfal u adolexxenti li għandhom 9 snin jew iktar b'iperkolesterolemija eteroziga familjali, il-pazjent għandu jitpoġġa fuq dieta standard li tbaxxi l-kolesterol, u din għandha titkompla waqt it-trattament.
English: Lescol and associated names (see Annex I) 40 mg capsules, hard
Maltese: Lescol u ismijiet assoċjati miegħu (ara Anness I) 40 mg kapsuli, iebsa
English: However it is still not possible to draw appropriate conclusions regarding the positive benefitrisk of doses >40mg in severe renal impairment, since a direct dose-level comparison between Lescol 40 vs 80mg/day was not possible, and the study population of patients with severe renal impairment was limited.
Maltese: Madankollu għadu mhux possibbli li joħorġu konklużjonijiet xierqa rigward ilbenefiċċju-riskju pożittiv tad-dożi >40 mg f'indeboliment renali sever, billi t-tqabbil dirett tal-livell tad-doża bejn Lescol 40 vs 80 mg/jum ma kienx possibbli, u l-popolazzjoni ta' studju ta' pazjenti b'indeboliment renali sever kienet limitata.
English: Warfarin and other coumarin derivatives
Maltese: Il-warfarina u derivattivi oħrajn tal-kumarina
English: A statement that Lescol/Lescol XL is contraindicated in patients with active liver disease, or unexplained, persistent elevations in serum transaminases is included in this section 4.2 as well as in sections 4.3, 4.4 and
Maltese: Id-dikjarazzjoni li Lescol/Lescol XL huwa kontraindikat f'pazjenti b'mard attiv fil-fwied, jew elevazzjonijiet persisitenti, mhux spjegati tat-transaminases fis-serum hija inkluża f'din is-sezzjoni 4.2 kif ukoll f'sezzjonijiet 4.3, 4.4 u 5
English: In the vast majority of EU Member States Lescol/Lescol XL is contraindicated in breastfeeding women and statement to this effect has been included by the MAH.
Maltese: Fil-maġġoranza vasta tal-Istati Membri tal-UE, Lescol/Lescol XL huwa kontraindikat f'nisa li jreddgħu u ġiet inkluża dikjarazzjoni f'dan ir-rigward mill-MAH.
English: More than 98% of the circulating drug is bound to plasma proteins, and this binding is not affected either by the concentration of fluvastatin, or by warfarin, salicylic acid or glyburide.
Maltese: Aktar minn 98% tal-mediċina li tiċċirkola teħel mal-proteini tal-plażma, u dan it-twaħħil mhuwiex affettwat la mill-konċentrazzjoni tal-fluvastatin, la mill-warfarina, la mill-aċidu saliċiliku u lanqas mill-gliburida.
English: Since HMG-CoA reductase inhibitors decrease the synthesis of cholesterol and possibly of other biologically active substances derived from cholesterol, they may cause foetal harm when administered to pregnant women.
Maltese: Minħabba li l-inibituri ta' HMG-CoA reductase inaqqsu s-sinteżi tal-kolesterol u possibbilment ta' sustanzi oħrajn bijoloġikament attivi li ġejjin mill-kolesterol, dawn jistgħu jagħmlu ħsara lill-fetu meta jingħataw lil nisa tqal.
English: Quantitative coronary angiograms were evaluated at baseline and after 2.5 years of treatment and were evaluable in 340 out of 429 patients.
Maltese: Kienu evalwati anġjogrammi koronarji kwantitattivi kemm fil-linja bażi kif ukoll wara sentejn u ħames xhur ta' kura u setgħu jiġu evalwati fi 340 pazjent minn 429.
English: Lescol® Capsule, hard 40mg
Maltese: Lescol® Capsule, hard 40 mg 40 mg Kapsula, iebsa
English: Lescol/Lescol XL is cleared by the liver, with less than 6% of the administered dose excreted into the urine.
Maltese: Lescol/Lescol XL huwa mneħħi mill-fwied, b'inqas minn 6% tad-doża amministrata titneħħa permezz tal-awrina.
English: For dose information in children and adolescents over 9 years, see section 3.
Maltese: Għal informazzjoni dwar dożi għat-tfal u l-adoloxxenti li għandhom aktar minn 9 snin, ara sezzjoni 3.
English: Digaril 40 mg caps
Maltese: Digaril 40 mg
English: Novartis Pharma B.V. Raapopseweg 1 ,6824 DP Arnhem,
Maltese: Novartis Pharma B.V. Raapopseweg 1
English: Lescol® Capsule, hard 20mg
Maltese: Lescol® Capsule, hard 20 mg 20 mg Kapsula, iebsa
English: Liver function tests and serum CK levels should be monitored.
Maltese: Għandu jkun hemm monitoraġġ tat-testijiet tal-funzjoni tal-kliewi u tal-livelli tas-serum fis-CK.
English: CLINICAL PARTICULARS
Maltese: Prodott Mediċinali
English: Lescol®XL Prolonged-release tablet 80mg 80 mg Prolonged release tablet
Maltese: Lescol®XL Prolonged-release tablet 80 mg
English: • 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: • It-trattament tal-iperkolesterolemija primarja jew dislipidemija mħallta, bħala żieda mad-dieta, meta r-rispons għad-dieta u trattamenti mhux farmakoloġiċi oħrajn (eż. eżerċizzju, tnaqqis fil-piż) ma jkunx adegwat.
English: Lactation
Maltese: Dislipidemija
English: - Colchicines (used to treat gout).
Maltese: - Kolkiċini (użati biex jikkuraw il-gotta).
English: For patients receiving oral sulfonylureas (glibenclamide (glyburide), tolbutamide) for the treatment of noninsulin-dependent (type 2) diabetes mellitus (NIDDM), addition of fluvastatin does not lead to clinically significant changes in glycaemic control.
Maltese: Għal pazjenti li qed jingħataw is-sulfonilurej mill-ħalq (il-glibenklamida [il-gliburida], it-tolbutamida) għall-kura tad-dijabete mellitus (tat-tip 2) mhux dipendenti fuq l-insulina (NIDDM), iż-żieda talfluvastatin ma twassalx għal tibdiliet sinifikanti klinikament fejn jidħol il-kontroll tal-gliċemija.
English: In the Lipoprotein and Coronary Atherosclerosis Study (LCAS), the effect of fluvastatin on coronary atherosclerosis was assessed by quantitative coronary angiography in male and female patients (35 to
Maltese: Waqt il-Lipoprotein and Coronary Atherosclerosis Study (LCAS), kien evalwat l-effett tal-fluvastatin fuq l-aterosklerożi koronarja permezz ta' anġjografija koronarja kwantitattiva f'pazjenti rġiel u nisa (ta' bejn 35 u 75 sena) b'mard tal-arterja koronarja u bil-livelli tal-LDL-C fil-linja bażi ta' bejn 3.0 u 4.9 mmol/l (bejn 115 u 190 mg/dl).
English: The maximum daily dose administered is 80 mg either as Lescol capsules 40 mg twice daily or as one Lescol 80 mg tablet once daily.
Maltese: Id-doża massima amministrata ta' kuljum hi ta' 80 mg jew bħala kapsuli Lescol tal-40 mg darbtejn kuljum jew bħala pillola waħda Lescol tat-80 mg darba kuljum.
English: Children and adolescents
Maltese: Aġenti kardjovaskulari