FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available for the use of fluvastatin in patients with the very rare condition of homozygous familial hypercholesterolaemia.
Slovenian: Glede uporabe fluvastatina pri bolnikih s homozigotno familiarno hiperholesterolemijo, ki je zelo redka bolezen, ni na voljo nobenih podatkov.
English: They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Slovenian: Uporabljajo jih bolniki, pri katerih dieta in telesna vadba ne zadoščata za uravnavanje ravni maščob v krvi.
English: How to store Lescol/Lescol XL Further information
Slovenian: Shranjevanje zdravila Lescol/Lescol XL Dodatne informacije
English: Isolated cases of myopathy have been reported post-marketing for concomitant administration of fluvastatin with ciclosporin and fluvastatin with colchicines.
Slovenian: Po prihodu zdravila na trg so poročali o posameznih primerih miopatije pri bolnikih, ki so sočasno jemali fluvastatin s ciklosporinom ali fluvastatin s kolhicinom.
English: ‘Treatment of adults with 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.'
Slovenian: „Zdravljenje odraslih bolnikov s primarno hiperholesterolemijo ali mešano dislipidemijo kot dodatek k dieti, če je odziv na dieto ali druge nefarmakološke ukrepe (npr. telesna vadba, znižanje telesne mase) nezadosten.“
English: Lescol and associated names (see Annex I) 20 mg capsules, hard
Slovenian: Lescol in povezana imena (glejte Dodatek I) 20 mg kapsule, trde
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
Slovenian: Kadar je treba sočasno s fluvastatinom uporabiti fibrat ali niacin, je treba skrbno pretehtati koristi in tveganja sočasnega zdravljenja (za uporabo s fibrati ali z niacinom glejte poglavje 4.5).
English: Table 1 Adverse reactions
Slovenian: Preglednica 1 Neželeni učinki
English: Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.'
Slovenian: Zdravilo Lescol/Lescol XL je bilo raziskano le pri otrocih s heterozigotno družinsko hiperholesterolemijo, starih 9 let ali več.“
English: Immune system disorders Very rare:
Slovenian: Bolezni imunskega sistema zelo redki:
English: There is no experience with the use of Lescol in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
Slovenian: O uporabi zdravila Lescol v kombinaciji z nikotinsko kislino, s holestiraminom ali s fibrati pri otrocih in mladostnikih ni nobenih izkušenj.
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).
Slovenian: Po rezultatih analize 24-tedenskih podatkov so odmerki po 20 mg, 40 mg ali 80 mg na dan sorazmerno z višino odmerka znižali koncentracije skupnega holesterola, LDL holesterola, apolipoproteina B in trigliceridov ter zvišali koncentracijo HDL holesterola (glejte preglednico 2).
English: 90429 Nürnberg, Germany
Slovenian: 90429 Nürnberg Nemčija
English: - The dose range for adults is 20 to 80 mg per day and depends on the extent of cholesterol lowering which needs to be achieved.
Slovenian: Koliko zdravila Lescol/Lescol XL je treba jemati - Obseg odmerkov za odrasle je od 20 do 80 mg na dan, pri čemer je višina odmerka odvisna od tega, koliko je treba znižati raven holesterola.
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.
Slovenian: CHMP se je strinjal z naslednjim besedilom: „Otroci in mladostniki s heterozigotno družinsko hiperholesterolemijo Pri otrocih in mladostnikih s heterozigotno družinsko hiperholesterolemijo, starih 9 let ali več, mora biti bolnik na standardni dieti za zniževanje ravni holesterola pred uvedbo zdravljenja z zdravilom Lescol/Lescol XL in med zdravljenjem.
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.
Slovenian: V drugi študiji (pri dečkih in deklicah v pubertetnem oziroma predpubertetnem obdobju) so odmerki zdravila Lescol 20 do 80 mg na dan znižali koncentracijo skupnega holesterola v plazmi za 22% in koncentracijo LDL holesterola v plazmi za 28%.
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 (Lescol 80 mg XL tablet) to achieve an LDL-C goal of < 130 mg/dl (3.4 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 (tablete zdravila Lescol XL 80 mg enkrat na dan), da bi dosegli ciljno koncentracijo LDL holesterola < 130 mg/dl (3,4 mmol/l).
English: - if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol/Lescol XL
Slovenian: Ne jemljite zdravila Lescol/Lescol XL - če ste alergični (preobčutljivi) na fluvastatin ali katerokoli sestavino zdravila Lescol/Lescol XL,
English: If muscular symptoms like pain, weakness or cramps occur in patients receiving fluvastatin, their CK levels should be measured.
Slovenian: Če se pri bolnikih, ki prejemajo fluvastatin, pojavijo mišični simptomi, na primer bolečina, oslabelosti ali mišični krči, je treba določiti vrednost kreatin-kinaze.
English: • Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
Slovenian: • Sekundarno preprečevanje poglavitnih srčnih dogodkov pri odraslih bolnikih s koronarno srčno boleznijo po perkutanih koronarnih intervencijskih posegih (glejte poglavje 5.1).
English: Lescol/Lescol XL has not been investigated and is not intended for the use in children below 9 years.
Slovenian: Zdravilo Lescol/Lescol XL in otroci/mladostniki Zdravila Lescol/Lescol XL niso proučevali pri otrocih, mlajših od 9 let, in ni namenjeno takim otrokom.
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
Slovenian: Lescol in povezana imena (glejte Dodatek I) 20 mg kapsule, trde Lescol in povezana imena (glejte Dodatek I) 40 mg kapsule, trde Lescol XL in povezana imena (glejte Dodatek I) 80 mg tablete s podaljšanim sproščanjem
English: Fluvastatin "Novartis" 20 mg-Kapseln
Slovenian: Fluvastatin "Novartis" 20 mgKapseln
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.
Slovenian: V predlog imetnika dovoljenja za promet z zdravilom sta vključeni izjava, da so bili v obdobju trženja zdravila prijavljeni posamezni primeri miopatij pri sočasni uporabi fluvastatina in ciklosporina, in izjava glede sočasnega dajanja fluvastatina in kolhicinov, o čemer se strinja tudi CHMP.
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 je mogoče zvišati na 80 mg na dan, kar bolnik vzame enkrat na dan (kot eno tableto Lescol XL) kadarkoli preko dneva ali pa po eno 40miligramsko kapsulo dvakrat na dan (eno kapsulo zjutraj in eno zvečer).
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.
Slovenian: Največji dnevni odmerek je 80 mg v obliki zdravila Lescol kapsule 40 mg dvakrat dnevno ali zdravila Lescol 80 mg tablete enkrat dnevno.
English: Lescol XL and associated names (see Annex I) 80 mg prolonged-release tablets
Slovenian: Lescol XL in povezana imena (glejte Dodatek I) 80 mg tablete s podaljšanim sproščanjem
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.
Slovenian: V prvi študiji (pri dečkih v predpubertetnem obdobju) so odmerki zdravila Lescol 20 do 80 mg na dan znižali koncentracijo skupnega holesterola v plazmi za 21 % in koncentracijo LDL holesterola v plazmi za 27 %.
English: Marked elevations of CK levels to more than 5x ULN developed in a very small number of patients (0.3 to 1.0%).
Slovenian: Pri zelo majhnem številu bolnikov (0,3 do 1,0 %) je prišlo do izrazitega zvišanja vrednost kreatin-kinaze na več kot 5kratno ZMN.
English: Common: affects 1 to 10 users in 100
Slovenian: Pogosti: pojavijo se pri 1 do 10 od 100 uporabnikov.
English: Treatment of adults with 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.
Slovenian: Zdravljenje odraslih s primarno hiperholesterolemijo ali z mešano dislipidemijo kot dodatek dieti, kadar odziv na dieto in druge vrste nefarmakološkega zdravljenja (na primer na telesno vadbo in zmanjšanje telesne mase) ni zadosten.
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.
Slovenian: • Zdravljenje primarne hiperholesterolemije ali mešane dislipidemije kot dodatek k dieti, če je odziv na dieto ali druge nefarmakološke ukrepe (npr. telesna vadba, znižanje telesne mase) nezadosten.
English: • Renal impairment.
Slovenian: • ledvična okvara,
English: Vascular disorders Very rare:
Slovenian: Žilne bolezni zelo redki:
English: SANDOZ S.p.A Address: Largo Umberto Boccioni 1
Slovenian: SANDOZ S.p.A Largo Umberto Boccioni 1 I-21040 Origgio / VA Italija
English: Lescol MR 80 mg - Filmtabletten
Slovenian: Lescol MR 80 mg - Filmtabletten80 mg filmsko obložena tableta peroralna uporaba
English: Rare: affects 1 to 10 users in 10,000
Slovenian: Redki: pojavijo se pri 1 do 10 od 10.000 uporabnikov.
English: • Secondary prevention of major cardiac events in adults with coronary heart disease (CHD)
Slovenian: • Sekundarno preprečevanje poglavitnih srčnih dogodkov pri odraslih bolnikih s koronarno srčno boleznijo (CHD) po perkutanih koronarnih intervencijskih posegih (PCI)
English: If you are pregnant, consult your doctor or pharmacist before taking Lescol/Lescol XL.
Slovenian: Če ste noseči, se pred začetkom uporabe zdravila Lescol/Lescol XL posvetujte z zdravnikom ali s farmacevtom.
English: If you forget to take Lescol/Lescol XL
Slovenian: Če ste pozabili vzeti zdravilo Lescol/Lescol XL
English: BATCH NUMBER [To be completed Nationally]
Slovenian: ŠTEVILKA SERIJE [Izpolni država članica]
English: BEFORE YOU TAKE LESCOL/LESCOL XL Follow all instructions given to you by your doctor carefully.
Slovenian: Pri jemanju zdravila Lescol/Lescol XL natančno upoštevajte zdravnikova navodila.
English: Read all of this leaflet carefully before you start using this medicine.
Slovenian: Pred začetkom jemanja natančno preberite navodilo!
English: If you become pregnant while taking this medicine, stop taking Lescol/Lescol XL and see your doctor.
Slovenian: Če zanosite v času jemanja zdravila Lescol/Lescol XL, prenehajte jemati zdravilo in obiščite zdravnika.
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
Slovenian: Lescol in povezana imena (glejte Dodatek I) 20 mg kapsule, trde Lescol in povezana imena (glejte Dodatek I) 40 mg kapsule, trde Lescol XL in povezana imena (glejte Dodatek I) 80 mg tablete s podaljšanim sproščanjem [Glejte Dodatek I - Izpolni država članica] fluvastatin
English: Novartis Pharma B.V. P.O.
Slovenian: Nizozemska Novartis Pharma B.V.
English: Kasou 21, 1086 Nicosia, Cyprus
Slovenian: Demetriades & Papaellinas Ltd. Kasou 21, 1086 Nicosia Ciper
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).
Slovenian: Srednja vrednost dosežene koncentracije LDL holesterola je bila 159 mg/dl, kar ustreza 4,1 mmol/l (v obsegu od 90 do 295 mg/dl, kar ustreza od 2,3 do 7,6 mmol/l).
English: Each Lescol 40 mg capsule contains 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid.
Slovenian: Ena kapsula Lescol 40 mg vsebuje 42,12 mg natrijevega fluvastatinata, kar ustreza 40 mg proste kisline fluvastatina.
English: No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with propranaolol, digoxin, losartan or amlodipine.
Slovenian: Pri sočasni uporabi fluvastatina s propranololom, digoksinom, losartanom ali amlodipinom ne prihaja do klinično pomembnih farmakokinetičnih interakcij.
English: Each Lescol XL 80 mg tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Slovenian: Ena tableta Lescol XL 80 mg tablet vsebuje 84,24 mg natrijevega fluvastatinata, kar ustreza 80 mg proste kisline fluvastatina.
English: The open-label design and the lack of a placebo control group did not allow a solid conclusion to be drafted regarding the efficacy and safety in this population due to some methodological limitations.
Slovenian: Glede učinkovitosti in varnosti v tej populaciji bolnikov ni bilo mogoče oblikovati trdnih zaključkov zaradi določenih metodoloških omejitev - nerandomizirane zasnove študije in odsotnosti kontrolne skupine s placebom.
English: One capsule of Lescol contains 21.06 mg fluvastatin sodium equivalent to 20 mg fluvastatin free acid or 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid.
Slovenian: Ena kapsula zdravila Lescol vsebuje 21,06 mg natrijevega fluvastatinata, kar ustreza 20 mg proste kisline fluvastatina, oziroma 42,12 mg natrijevega fluvastatinata, kar ustreza 40 mg proste kisline fluvastatina.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex 1 - To be completed nationally]
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
English: The majority of patients in both studies (83% in the first study and 89% in the second study) were titrated to the maximum daily dose of 80 mg. At study endpoint, 26 to 30% of patients in both studies achieved a targeted LDL-C goal of < 130 mg/dl (3.4 mmol/l).
Slovenian: V obeh študijah so pri večini bolnikov (pri 83 % v prvi študiji in pri 89 % v drugi) titrirali odmerek do najvišjega dnevnega odmerka 80 mg.
English: Each Lescol 20 mg capsule contains 21.06 mg fluvastatin sodium equivalent to 20 mg fluvastatin free acid.
Slovenian: Ena kapsula Lescol 20 mg vsebuje 21,06 mg natrijevega fluvastatinata, kar ustreza 20 mg proste kisline fluvastatina.
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).
Slovenian: Povprečna koncentracija LDL holesterola ob izhodišču je bila 225 mg/dl, kar ustreza 5,8 mmol/l (v obsegu 148-343 mg/dl, kar ustreza 3,8-8,9 mmol/l).
English: HOW TO TAKE LESCOL/LESCOL XL
Slovenian: KAKO JEMATI ZDRAVILO LESCOL/LESCOL XL
English: Lescol and Lescol XL can be taken with or without meals.
Slovenian: Tako zdravilo Lescol kot Lescol XL lahko jemljete skupaj z obrokom hrane ali brez njega.
English: Very rare:
Slovenian: glavobol zelo redki:
English: 140 00 Praha 4 - Nusle, Czech Republic
Slovenian: 13000 Prague 3 Češka
English: 80 mg Film-coated tablet
Slovenian: 80 mg filmsko obložena tableta peroralna uporaba
English: Colchicines
Slovenian: Kolhicini
English: One prolonged-release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Slovenian: Ena tableta s podaljšanim sproščanjem zdravila Lescol XL vsebuje 84,24 mg natrijevega fluvastatinata, kar ustreza 80 mg proste kisline fluvastatina.
English: Starting and maintenance doses should be individualized according to the baseline LDL-C levels and the treatment goal to be accomplished.
Slovenian: Začetne in vzdrževalne odmerke je treba prilagoditi posameznemu bolniku glede na njegove izhodiščne koncentracije LDL holesterola in zastavljeni cilj zdravljenja.
English: MARKETING AUTHORISATION HOLDER [See Annex 1 - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - Izpolni država članica]
English: However, since an increased risk of myopathy has been observed in patients receiving other HMG-CoA reductase inhibitors together with fibrates or niacin, these combinations should be used with caution.
Slovenian: Vendar je treba te kombinacije uporabljati previdno zaradi dokazanega večjega tveganja miopatij pri bolnikih, ki so prejemali druge zaviralce HMG-CoA-reduktaze sočasno s fibrati ali niacinom.
English: Dyslipidaemia
Slovenian: nespečnost
English: Caution should be exercised when Lescol/Lescol XL is administered to patients with a history of liver disease or heavy alcohol ingestion.
Slovenian: Pri uporabi zdravila Lescol/Lescol XL pri bolnikih z anamnezo jetrne bolezni in pri bolnikih, ki zaužijejo večje količine alkohola, je potrebna previdnost.
English: Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finland
Slovenian: Novartis Finland Oy Metsänneidonkuja 10 FI-02130 Espoo Finska
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).
Slovenian: Povprečna koncentracija LDL holesterola ob izhodišču je bila 226 mg/dl, kar ustreza 5,8 mmol/l (v obsegu 137-354 mg/dl, kar ustreza 3,6-9,2 mmol/l).
English: The recommendation that Lescol capsules can be taken regardless of meals is largely consistent across the EU Member States.
Slovenian: Časovna razporeditev jemanja zdravila in obrokov Skoraj vse države članice EU so zagovarjale priporočilo, da se kapsule Lescol jemljejo ne glede na obroke.
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).
Slovenian: Zdravilo Lescol XL, ki so ga bolniki jemali v obliki enega 80miligramskega odmerka enkrat na dan, je pomembno znižalo koncentracije skupnega holesterola, LDL holesterola, trigliceridov in apolipoproteina B (glejte preglednico 2).
English: Uncommon: affects 1 to 10 users in 1,000
Slovenian: Občasni: pojavijo se pri 1 do 10 od 1.000 uporabnikov.
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.
Slovenian: Sočasna uporaba fluvastatina s cimetidinom, ranitidinom ali omeprazolom povzroči povečanje biološke uporabnosti fluvastatina, ki pa nima nikakršnega kliničnega pomena.
English: 6.1 List of excipients [To be completed Nationally]
Slovenian: 6.1 Seznam pomožnih snovi [Izpolni država članica]
English: To maintain the benefits of your treatment, do not stop taking Lescol/ Lescol XL unless your doctor tells you to. You must continue to take Lescol/Lescol XL as directed to keep the levels of your ‘bad' cholesterol down.
Slovenian: Zdravilo Lescol/Lescol XL morate jemati še naprej tako, kot vam naroči zdravnik, da bo raven vašega‘slabega' holesterola ostala nizka.
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).
Slovenian: Povprečna dosežena koncentracija LDL holesterola je bila 161 mg/dl, kar ustreza 4,2 mmol/l (v obsegu od 74 do 336 mg/dl, kar ustreza od 1,9 do 8,7 mmol/l).
English: This leaflet was last approved in [To be completed nationally]
Slovenian: Navodilo je bilo odobreno [Izpolni država članica]
English: 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.
Slovenian: Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Otroci in mladostniki, ki so stari 9 let ali več in imajo heterozigotno familiarno hiperholesterolemijo, morajo začeti s standardno dieto za zniževanje koncentracije holesterola pred začetkom zdravljenja z zdravilom Lescol/Lescol XL in z njo nadaljevati tudi med zdravljenjem.
English: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Slovenian: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finska
English: 20 mg Capsules, hard
Slovenian: 20 mg kapsule, trde
English: Use reliable contraception for the whole time that you are taking Lescol / Lescol XL.
Slovenian: Ves čas zdravljenja z zdravilom Lescol/Lescol XL uporabljajte zanesljivo kontracepcijsko metodo.
English: Myalgia, muscle weakness, myopathy
Slovenian: mialgija, mišična oslabelost, miopatija zelo redki:
English: 80 mg prolonged-release tablets Member State
Slovenian: 80 mg tablete s podaljšanim sproščanjem država članica zdravilo
English: Whilst on treatment
Slovenian: Med zdravljenjem:
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800
Slovenian: Medialaan, 40 bus 1 1800 Vilvoorde Belgija
English: Av. Diagonal, 507
Slovenian: Novartis Farmacéutica S.A. Av. Diagonal, 507
English: 40 mg Capsules, hard
Slovenian: 40 mg kapsule, trde
English: Czech Republic Novartis, s.r.o.
Slovenian: Novartis, s.r.o.
English: Starting and maintenance dose of fluvastatin should be as low as possible when combined with ciclosporin.
Slovenian: Pri sočasni uporabi s ciklosporinom je treba uporabiti karseda nizek začetni in vzdrževalni odmerek fluvastatina.
English: 40 mg capsules Member State
Slovenian: 40 mg kapsule država članica zdravilo
English: The recommended starting dose is one 20 mg Lescol capsule.
Slovenian: Priporočeni začetni odmerek je ena kapsula zdravila Lescol 20 mg. Odmerek je treba prilagajati v presledkih po 6 tednov.
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
Slovenian: V študiji lipoproteinov in koronarne ateroskleroze (Lipoprotein and Coronary Atherosclerosis StudyLCAS) so ocenjevali učinek fluvastatina na koronarno aterosklerozo s kvantitativno koronarno angiografijo pri bolnikih in bolnicah (starih od 35 do 75 let) s koronarno boleznijo srca in z izhodiščno koncentracijo LDL holesterola od 3,0 do 4,9 mmol/l (115 do 190 mg/dl).
English: Excipients: [To be completed nationally]
Slovenian: Pomožne snovi: [Izpolni država članica]
English: When to take Lescol/ Lescol XL
Slovenian: Kdaj je treba jemati zdravilo Lescol/Lescol XL
English: Myotoxicity, including muscle pain and weakness and rhabdomyolysis, has been reported in isolated cases with concomitant administration of colchicines.
Slovenian: Pri sočasni uporabi kolhicinov so poročali o posameznih primerih toksičnega delovanja na mišice, vključno z bolečinami v mišicah, šibkostjo mišic in rabdomiolizo.
English: Novartis Pharma B.V. Raapopseweg 1 ,6824 DP Arnhem,
Slovenian: 6824 DP Arnhem
English: Impaired liver function
Slovenian: Bolniki z okvarjenim delovanjem ledvic
English: Biochemical abnormalities of liver function have been associated with HMG-CoA reductase inhibitors and other lipid-lowering agents.
Slovenian: Zaviralce reduktaze HMG-CoA in druge hipolipemike povezujejo z odstopanjem od normalnih vrednosti biokemičnih parametrov delovanja jeter.