FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are over 70 years your doctor may want to check if you have risk factors for muscular diseases.
Slovenian: Zdravilo Lescol/Lescol XL in ljudje, starejši od 70 let Če ste starejši od 70 let, bo zdravnik morda želel preveriti, ali imate dejavnike tveganja za bolezni mišic, zato boste morali morda opraviti posebne krvne preiskave.
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).'
Slovenian: CHMP se je strinjal z naslednjim besedilom za to indikacijo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom: „Sekundarno preprečevanje poglavitnih neželenih srčnih dogodkov pri odraslih bolnikih s koronarno srčno boleznijo po perkutanih koronarnih intervencijskih posegih (glejte poglavje 5.1).“
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.'
Slovenian: CHMP se je strinjal z naslednjim besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom: „Pri bolnikih s koronarno srčno boleznijo po perkutanih koronarnih intervencijskih posegih je primeren dnevni odmerek 80 mg.“
English: If muscular symptoms are severe and cause daily discomfort, even if CK levels are elevated to ≤ 5x ULN, treatment discontinuation should be considered.
Slovenian: Če so mišični simptomi hudi in povzročajo vsakodnevne težave, presodite o prekinitvi zdravljenja, tudi če je vrednost kreatin-kinaze zvišana na ≤ 5-kratno ZMN.
English: There is no current evidence to require routine monitoring of plasma total CK or other muscle enzyme levels in asymptomatic patients on statins.
Slovenian: Zaenkrat ni dokazov, da bi bilo treba pri asimptomatičnih bolnikih, ki jemljejo statine, rutinsko spremljati vrednosti celotne kreatin-kinaze ali drugih mišičnih encimov v plazmi.
English: The first marketing authorization was issued for Lescol XL (Lescol extended release) 80 mg tablets in 2000.
Slovenian: Leta 2000 je bilo izdano prvo dovoljenje za promet z zdravilom Lescol XL (Lescol s podaljšanim sproščanjem) 80 mg tablete.
English: If you take more Lescol/Lescol XL than you should If you have accidentally taken too much Lescol/Lescol XL, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Lescol/Lescol XL, kot bi smeli Če ste pomotoma vzeli prevelik odmerek zdravila Lescol/Lescol XL, to takoj sporočite svojemu zdravniku.
English: Driving and using machines There is no information on the effects of Lescol/Lescol XL on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev O vplivu zdravila Lescol/Lescol XL na sposobnost za upravljanje vozil in uporabo strojev ni podatkov.
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).
Slovenian: V študijo so bili vključeni bolniki moškega in ženskega spola (v starosti od 18 do 80 let), ki so imeli ob izhodišču skupni holesterol od 3,5 do 7,0 mm/l (135 do 270 mg/dl).
English: Taking Lescol/Lescol XL with food and drink You can take Lescol/Lescol XL with or without food.
Slovenian: Jemanje zdravila Lescol/Lescol XL s hrano in pijačo Zdravilo Lescol/Lescol XL lahko jemljete skupaj s hrano ali brez nje.
English: [To be completed Nationally]
Slovenian: [Izpolni država članica]
English: The CHMP agreed with the following wording proposed by the MAH for this indication:
Slovenian: CHMP se je strinjal z naslednjim besedilom za to indikacijo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
English: No dose adjustments are therefore necessary in these patients however, due to limited experience with doses >40mg/day in case of severe renal impairment (CrCL <0,5 mL/sec or 30 mL/min), these doses should be initiated with caution.'
Slovenian: Pri teh bolnikih zato niso potrebne prilagoditve odmerka, ker pa so izkušnje z uporabo odmerkov > 40 mg/dan pri bolnikih s hudo okvarjenim delovanjem ledvic (CrCL <0,5 mL/s ali 30 mL/min) omejene, je treba te odmerke uvajati previdno.“
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.
Slovenian: Vendar še vedno niso mogoči ustrezni zaključki glede pozitivnega razmerja med koristmi in tveganji odmerkov > 40 mg pri bolnikih s hudo okvarjenim delovanjem ledvic, saj neposredna primerjava med zdraviloma Lescol 40 in
English: The use of fluvastatin in combination with nicotinic acid, cholestyramine, or fibrates in children and adolescents has not been investigated.
Slovenian: Uporaba fluvastatina v kombinaciji z nikotinsko kislino, holestiraminom ali fibrati pri otrocih in mladostnikih ni bila raziskana.
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.
Slovenian: Pri sočasni uporabi niti kapsule Lescol (40 mg fluvastatina) niti tablete Lescol XL (80 mg fluvastatina) niso vplivale na biološko uporabnost ciklosporina.
English: Liver function tests will normally be done before you start
Slovenian: Za odkrivanje morebitnih neželenih učinkov vam bodo pregledovali teste jetrne funkcije najprej preden začnete zdravljenje z zdravilom
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.
Slovenian: V 12 s placebom kontroliranih študijah, ki so zajemale bolnike s hiperlipoproteinemijo vrste IIa ali IIb, je 1.621 bolnikov prejemalo samo zdravilo Lescol z odmerjanjem po 20 mg, 40 mg ali 80 mg na dan (40 mg dvakrat na dan) vsaj 6 tednov.
English: Difficulty in sleeping, headache, stomach discomfort, abdominal pain, nausea.
Slovenian: Pogosti: nespečnost, glavobol, želodčne težave, bolečine v trebuhu, slabost s siljenjem na bruhanje.
English: Frimley Business Park Frimley, Camberley
Slovenian: Frimley, Camberley
English: In cases where coadministration with a fibrate or niacin is necessary, the benefit and the risk of concurrent treatment should be carefully considered (for use with fibrates or niacin see section 4.5).'
Slovenian: Kadar je sočasno dajanje s fibratom ali niacinom potrebno, je treba skrbno oceniti koristi in tveganja sočasnega zdravljenja (za uporabo s fibrati ali niacinom glejte poglavje 4.5).“
English: The paediatric indication was not granted during the assessment of paediatric data through the EU worksharing procedure.
Slovenian: Med vrednotenjem pediatričnih podatkov v projektu „EU Work-sharing“ pediatrična indikacija ni bila odobrena.
English: The maximum lipid-lowering effect with a given dose is achieved within 4 weeks.
Slovenian: Zdravilo doseže največji učinek zniževanja lipidov pri danem odmerku v 4 tednih.
English: Lescol/Lescol XL reduces total-C, LDL-C, Apo B, and triglycerides, and increases HDL-C in patients with hypercholesterolaemia and mixed dyslipidaemia.
Slovenian: Zdravilo Lescol/Lescol XL znižuje koncentracije skupnega holesterola, LDL holesterola, apolipoproteina B in trigliceridov ter zvišuje koncentracijo HDL holesterola pri bolnikih s hiperholesterolemijo in mešano dislipidemijo.
English: Very rare: affects less than 1 user in 10,000
Slovenian: Zelo redki: pojavijo se pri manj kot 1 od 10.000 uporabnikov.
English: [See Annex I - To be completed Nationally]
Slovenian: [Glejte Dodatek I - Izpolni država članica]
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.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2, ki so bili zdravljeni z glibenklamidom (n=32), je uporaba fluvastatina (40 mg dvakrat na dan 14 dni) zvišala povprečne Cmax za približno 50 %, povečala AUC za približno 69 % in podaljšala t1/2 glibenklamida za približno 121 %.
English: Some rare or very rare effects could be serious: get medical help immediately.
Slovenian: Nekateri redki ali zelo redki neželeni učinki so lahko resni - takoj poiščite zdravniško pomoč: - če imate nepojasnjene bolečine v mišicah, če so mišice občutljive ali oslabele.
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.
Slovenian: Študijo LIPS (LES-EUR-01) so izvedli, da bi ugotovili, ali zdravljenje s fluvastatinom zmanjša dolgoročno tveganje dogodkov MACE (tj. srčna smrt, miokardni infarkt (MI)
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lescol and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom Lescol in z njim povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
English: 114 patients (66 boys and 48 girls) were treated with fluvastatin administered as either Lescol capsules (20 mg/day to 40 mg twice daily) or Lescol XL 80 mg prolonged-release tablets once daily using a dose-titration regimen based upon LDL-C response.
Slovenian: 114 bolnikov (66 dečkov in 48 deklic) so zdravili s fluvastatinom, ki so ga dajali v obliki kapsul zdravila Lescol (20 mg na dan do 40 mg dvakrat na dan) ali v obliki zdravila Lescol XL 80 mg tablet s podaljšanim sproščanjem enkrat na dan, z uporabo sheme za titracijo odmerka, ki je temeljila na odzivu koncentracije LDL holesterola.
English: Since an increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMGCoA reductase inhibitors together with any of these molecules, the benefit and the risk of concurrent treatment should be carefully weighed and these combinations should only be used with caution (see section
Slovenian: Ker pa so pri bolnikih, ki skupaj s katerokoli od teh učinkovin prejemajo druge zaviralce reduktaze HMG-CoA, opazili povečano tveganje za miopatijo in/ali rabdomiolizo, je treba skrbno pretehtati koristi in tveganja sočasnega zdravljenja in navedene kombinacije uporabljati samo s previdnostjo (glejte poglavje 4.4).
English: The paediatric information from the EU Worksharing Project has also been implemented with minor editorial changes.
Slovenian: Z manjšimi uredniškimi spremembami so bile vnesene tudi pediatrične informacije iz projekta „EU Worksharing Project“.
English: Dose adjustments may be made by your doctor at 6-week intervals.
Slovenian: Zdravnik vam lahko prilagaja odmerjanje vsakih 6 tednov.
English: Fluvastatin "Novartis" MR 80 mgFilmtabletten
Slovenian: Fluvastatin "Novartis" MR 80 mg - Filmtabletten
English: If any of these apply to you, tell your doctor before you take Lescol/Lescol XL.
Slovenian: Če kaj od zgoraj navedenega velja za vas, to povejte svojemu zdravniku, preden vzamete zdravilo Lescol/Lescol XL.
English: Dose adjustments should be made at intervals of 4 weeks or more.
Slovenian: Odmerjanje je treba prilagajati v 4-tedenskih ali daljših intervalih.
English: If any of these apply to you, do not take Lescol/ Lescol XL and tell your doctor.
Slovenian: Če karkoli od navedenega velja za vas, ne jemljite zdravila Lescol/Lescol XL, ampak obvestite zdravnika.
English: If you are taking Lescol, take your dose in the evening or at bedtime.
Slovenian: Če jemljete zdravilo Lescol, vzemite odmerek zvečer oziroma pred spanjem.
English: The CHMP concluded that the following indications are supported by the available data submitted by the MAH:
Slovenian: CHMP je zaključil, da razpoložljivi podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, podpirajo naslednje indikacije:
English: Hepatitis Skin and subcutaneous tissue disorders Rare:
Slovenian: Bolezni kože in podkožja redki:
English: If a patient becomes pregnant while taking Lescol/Lescol XL, therapy should be discontinued.
Slovenian: Če ženska zanosi v času zdravljenja z zdravilom Lescol/Lescol XL, je treba zdravljenje prekiniti.
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.
Slovenian: Fluvastatin, povsem sintetična učinkovina za zniževanje koncentracije holesterola, je kompetitiven zaviralec reduktaze HMG-CoA, ki je odgovorna za pretvorbo HMG-CoA v mevalonat, predstopnjo sterolov, med katere sodi tudi holesterol.
English: Baseline TG ≥ 200 mg/dl
Slovenian: izhodiščna koncentracija trigliceridov ≥ 200 mg/dl
English: Dose adjustments may be made by your doctor at 4-week or longer intervals.
Slovenian: Zdravnik vam lahko prilagaja odmerjanje vsake 4 tedne ali v daljših intervalih.
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.
Slovenian: Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Varnostne lastnosti fluvastatina pri otrocih in mladostnikih s heterozigotno familiarno hiperholesterolemijo, kot so jih ocenili pri 114 bolnikih, starih 9 do 17 let, ki so jih zdravili v dveh odprtih neprimerjalnih kliničnih preskušanjih, so bile podobne kot pri odraslih.
English: The Netherlands
Slovenian: The Nizozemska
English: - the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
Slovenian: - predmet napotitve je bilo usklajevanje povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo,
English: Largo Boccioni, 1, 21040 Origgio (VA), Italy
Slovenian: Largo Boccioni, 1 21040 Origgio (VA), Italija
English: SPECIAL STORAGE CONDITIONS [To be completed Nationally]
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE [Izpolni država članica]
English: To date there has been limited experience with overdose of fluvastatin.
Slovenian: Izkušenj s prevelikimi odmerki fluvastatina je zelo malo.
English: Quantitative coronary angiograms were evaluated at baseline and after 2.5 years of treatment and were evaluable in 340 out of 429 patients.
Slovenian: Kvantitativne koronarne angiograme so ocenjevali v začetku študije in po dveh letih in pol zdravljenja.
English: However, do not take it if there is less than 4 hours before your next dose.
Slovenian: Vzemite en odmerek takoj, ko se spomnite, razen če morate naslednji odmerek vzeti čez manj kot 4 ure.
English: What Lescol/Lescol XL looks like and contents of the pack [To be completed nationally]
Slovenian: Izgled zdravila Lescol/Lescol XL in vsebina pakiranja [Izpolni država članica]
English: If CK levels are still significantly elevated (> 5x ULN) at baseline, treatment should not be started.
Slovenian: Če je vrednost kreatin-kinaze ob izhodišču še vedno pomembno zvišana (> 5-kratna ZMN), ni primerno začeti z zdravljenjem.
English: 20 mg and 40 mg capsules Member State
Slovenian: 20 mg in 40 mg kapsule država članica zdravilo
English: If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Slovenian: V primeru suma na intersticijsko pljučno bolezen je treba zdravljenje s statini prekiniti.
English: Very common: affects more than 1 user in 10
Slovenian: Zelo pogosti: pojavijo se pri več kot 1 od 10 uporabnikov.
English: Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, United Kingdom
Slovenian: Estonija, Bolgarija, Ciper, Češka, Grčija, Madžarska, Irska, Latvija, Litva, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Velika Britanija
English: 8 , Quinta de Beloura 2710-444, Sintra, Portugal
Slovenian: 2710-444 Sintra
English: Lescol 20 mg, 40 mg are hard gelatine capsules and Lescol 80 mg is a modified release film coated tablet.
Slovenian: Zdravili Lescol 20 mg, 40 mg sta trdi kapsuli iz želatine, zdravilo Lescol 80 mg pa filmsko obložena tableta s spremenjenim sproščanjem.
English: The dose may be uptitrated to 80 mg daily, administered as a single dose (one Lescol XL tablet) at any time of the day or as one 40 mg capsule given twice daily (one in the morning and one in the evening).'
Slovenian: Odmerek se lahko povečuje do 80 mg dnevno in se vzame kot enkratni odmerek (ena tableta zdravila Lescol XL) ob kateri koli uri ali kot ena kapsula 40 mg dvakrat dnevno (ena zjutraj in ena zvečer).“
English: No dose adjustments are therefore necessary in these patients however, due to limited experience with doses >40mg/day in case of severe renal impairment (CrCL <0,5 mL/sec or 30 mL/min), these doses should be initiated with caution.
Slovenian: Prilagajanje odmerkov pri teh bolnikih ni potrebno, vendar je zaradi majhnega obsega izkušenj z odmerki > 40 mg/dan v primerih hude okvare ledvic (pri bolnikih z očistkom kreatinina < 0,5 ml/s oziroma 30 ml/min) potrebna previdnost pri uvajanju takih odmerkov.
English: The MAH's proposal was amended and considered to be acceptable by the CHMP:
Slovenian: CHMP je spremenil predlog imetnika dovoljenja za promet z zdravilom in ga nato štel za sprejemljivega:
English: Na Pankráci 1724/129
Slovenian: Na Pankráci 1724/129 140 00 Praha 4 - Nusle Češka
English: Based on the Pharmacovigilance Working Party (PhVWP) Report on the association of HMG CoA reductase inhibitors, this section has also been updated to include interstitial lung disease.
Slovenian: To poglavje je bilo tudi posodobljeno na podlagi poročila Delovne skupine za farmakovigilanco (PhVWP) o povezavi z zaviralci HMG-CoA-reduktaze z vključitvijo intersticijske pljučne bolezni.
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
Slovenian: Preglednica 2 Mediane odstotne spremembe lipidnih parametrov od izhodišča do konca 24. tedna študije, kontrolirane s placebom (Lescol) in aktivno kontrolirana preskušanja (Lescol XL)
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Slovenian: Pri uporabi statinov, zlasti pri dolgotrajni, so izjemoma poročali o primerih intersticijske pljučne bolezni (glejte poglavje 4.8).
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).
Slovenian: Vsi bolniki so začeli zdravljenje s kapsulami zdravila Lescol 20 mg enkrat na dan, nato pa so jim odmerjanje prilagajali vsakih 6 tednov na 40 mg na dan in nato na 80 mg na dan (dvakrat na dan po 40 mg), da bi dosegli ciljno koncentracijo LDL holesterola 96,7 do 123,7 mg/dl (2,5 mmol/l do 3,2 mmol/l).
English: In patients with coronary heart disease after percutaneous coronary interventions the appropriate daily dose is 80 mg.
Slovenian: Sekundarno preprečevanje koronarnih dogodkov pri bolnikih s koronarno srčno boleznijo Pri bolnikih s koronarno boleznijo srca po perkutanem koronarnem posegu je ustrezen dnevni odmerek 80 mg.
English: In a fed state, the substance is absorbed at a reduced rate,
Slovenian: V stanju sitosti se zdravilo absorbira počasneje.
English: Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.
Slovenian: Uporabo zdravila Lescol/Lescol XL so proučevali samo pri otrocih, ki so bili stari 9 let ali več in so imeli heterozigotno familiarno hiperholesterolemijo.
English: Specific treatment is not available for Lescol/Lescol XL overdose.
Slovenian: Pri uporabi prevelikih odmerkov zdravila Lescol/Lescol XL ni na voljo specifičnega zdravljenja.
English: Lescol 40 mg twice daily1
Slovenian: Lescol 40 mg dvakrat na dan1
English: Significant increases in HDL-C were also observed.
Slovenian: Opažali so tudi pomembno zvišanje koncentracije HDL holesterola.
English: Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark
Slovenian: Lyngbyvej 172 2100 København Ø Danska
English: For patients requiring LDL-C reduction to a goal of < 25% a starting dose of 20 mg may be used as one capsule in the evening.
Slovenian: Za bolnike s ciljem < 25-odstotnega znižanja ravni LDL-C se lahko uporabi začetni odmerek 20 mg v obliki ene kapsule zvečer.
English: It is recommended that prothrombin times are monitored when fluvastatin treatment is initiated, discontinued, or the dosage changes in patients receiving warfarin or other coumarin derivatives.
Slovenian: Ob uvedbi ali prekinitvi zdravljenja s fluvastatinom in ob spreminjanju odmerjanja fluvastatina je pri bolnikih, ki prejemajo varfarin ali druge kumarinske derivate, priporočeno spremljanje protrombinskega časa.
English: Doctor Zamenhof nº 36 28027 Madrid Spain
Slovenian: Laboratorios Andrómaco, S.A. Doctor Zamenhof nº 36 28027 Madrid
English: Lescol and associated names (see Annex I) 40 mg capsules, hard
Slovenian: Lescol in povezana imena (glejte Dodatek I) 40 mg kapsule, trde
English: Based on the pharmacokinetic data, no monitoring or dosage adjustments are required when fluvastatin is concomitantly administered with these agents.
Slovenian: Glede na farmakokinetične podatke pri sočasni uporabi fluvastatina in navedenih zdravil ni potrebno posebno spremljanje ali prilagajanje odmerjanja.
English: Oral antidiabetic agents
Slovenian: Peroralni antidiabetiki
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.
Slovenian: V veliki večini držav članic EU je zdravilo Lescol/Lescol XL kontraindicirano pri doječih materah.
English: Doses should be individualised according to baseline LDL-C levels and the recommended goal of therapy to be accomplished.
Slovenian: Odmerke je treba prilagoditi posameznemu bolniku glede na izhodiščne ravni LDL-C, da dosežemo priporočeni cilj zdravljenja.
English: What Lescol/Lescol XL contains - The active substance is fluvastatin sodium
Slovenian: Kaj vsebuje zdravilo Lescol/Lescol XL - Zdravilna učinkovina je natrijev fluvastatinat.
English: Fluvastatin is absorbed rapidly and completely (98%) after oral administration of a solution to fasted volunteers.
Slovenian: Po peroralni uporabi raztopine na tešče pri prostovoljcih se je fluvastatin hitro in popolnoma (98odstotno) absorbiral.
English: Fluvastatin "Novartis" 40 mg-Kapseln
Slovenian: Fluvastatin "Novartis" 40 mgKapseln
English: For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening.
Slovenian: Za bolnike s ciljem ≥ 25-odstotnega znižanja ravni LDL-C je priporočeni začetni odmerek 40 mg v obliki ene kapsule zvečer.
English: Children and adolescents with heterozygous familial hypercholesterolaemia The safety and efficacy of Lescol and Lescol XL in children and adolescent patients aged 9-16 years of age with heterozygous familial hypercholesterolaemia has been evaluated in 2 open-label, uncontrolled clinical trials of 2 years' duration.
Slovenian: Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Varnost in učinkovitost zdravil Lescol in Lescol XL pri otrocih in mladostnikih, ki so bili stari 916 let in so imeli heterozigotno familiarno hiperholesterolemijo, so ocenjevali v 2 odprtih nekontroliranih kliničnih preskušanjih, ki sta trajali po 2 leti.