natgillin/translations-raw huggingface dataset:
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.
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.
The Netherlands
The Nizozemska
- the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet.
- predmet napotitve je bilo usklajevanje povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo,
Largo Boccioni, 1, 21040 Origgio (VA), Italy
Largo Boccioni, 1 21040 Origgio (VA), Italija
SPECIAL STORAGE CONDITIONS [To be completed Nationally]
POSEBNA NAVODILA ZA SHRANJEVANJE [Izpolni država članica]
To date there has been limited experience with overdose of fluvastatin.
Izkušenj s prevelikimi odmerki fluvastatina je zelo malo.
Quantitative coronary angiograms were evaluated at baseline and after 2.5 years of treatment and were evaluable in 340 out of 429 patients.
Kvantitativne koronarne angiograme so ocenjevali v začetku študije in po dveh letih in pol zdravljenja.
However, do not take it if there is less than 4 hours before your next dose.
Vzemite en odmerek takoj, ko se spomnite, razen če morate naslednji odmerek vzeti čez manj kot 4 ure.
What Lescol/Lescol XL looks like and contents of the pack [To be completed nationally]
Izgled zdravila Lescol/Lescol XL in vsebina pakiranja [Izpolni država članica]
If CK levels are still significantly elevated (> 5x ULN) at baseline, treatment should not be started.
Če je vrednost kreatin-kinaze ob izhodišču še vedno pomembno zvišana (> 5-kratna ZMN), ni primerno začeti z zdravljenjem.
20 mg and 40 mg capsules Member State
20 mg in 40 mg kapsule država članica zdravilo
If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
V primeru suma na intersticijsko pljučno bolezen je treba zdravljenje s statini prekiniti.
Very common: affects more than 1 user in 10
Zelo pogosti: pojavijo se pri več kot 1 od 10 uporabnikov.
Hungary, Ireland, Latvia, Lithuania, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, United Kingdom
Estonija, Bolgarija, Ciper, Češka, Grčija, Madžarska, Irska, Latvija, Litva, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Velika Britanija
8 , Quinta de Beloura 2710-444, Sintra, Portugal
2710-444 Sintra
Lescol 20 mg, 40 mg are hard gelatine capsules and Lescol 80 mg is a modified release film coated tablet.
Zdravili Lescol 20 mg, 40 mg sta trdi kapsuli iz želatine, zdravilo Lescol 80 mg pa filmsko obložena tableta s spremenjenim sproščanjem.
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).'
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).“
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.
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.
The MAH's proposal was amended and considered to be acceptable by the CHMP:
CHMP je spremenil predlog imetnika dovoljenja za promet z zdravilom in ga nato štel za sprejemljivega:
Na Pankráci 1724/129
Na Pankráci 1724/129 140 00 Praha 4 - Nusle Češka
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.
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.
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
Preglednica 2 Mediane odstotne spremembe lipidnih parametrov od izhodišča do konca 24. tedna študije, kontrolirane s placebom (Lescol) in aktivno kontrolirana preskušanja (Lescol XL)
Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Pri uporabi statinov, zlasti pri dolgotrajni, so izjemoma poročali o primerih intersticijske pljučne bolezni (glejte poglavje 4.8).
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).
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).
In patients with coronary heart disease after percutaneous coronary interventions the appropriate daily dose is 80 mg.
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.
In a fed state, the substance is absorbed at a reduced rate,
V stanju sitosti se zdravilo absorbira počasneje.
Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.
Uporabo zdravila Lescol/Lescol XL so proučevali samo pri otrocih, ki so bili stari 9 let ali več in so imeli heterozigotno familiarno hiperholesterolemijo.
Specific treatment is not available for Lescol/Lescol XL overdose.
Pri uporabi prevelikih odmerkov zdravila Lescol/Lescol XL ni na voljo specifičnega zdravljenja.
Lescol 40 mg twice daily1
Lescol 40 mg dvakrat na dan1
Significant increases in HDL-C were also observed.
Opažali so tudi pomembno zvišanje koncentracije HDL holesterola.
Novartis Healthcare A/S Lyngbyvej 172, 2100 København Ø, Denmark
Lyngbyvej 172 2100 København Ø Danska
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.
Za bolnike s ciljem < 25-odstotnega znižanja ravni LDL-C se lahko uporabi začetni odmerek 20 mg v obliki ene kapsule zvečer.
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.
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.
Lescol and associated names (see Annex I) 40 mg capsules, hard
Lescol in povezana imena (glejte Dodatek I) 40 mg kapsule, trde
Based on the pharmacokinetic data, no monitoring or dosage adjustments are required when fluvastatin is concomitantly administered with these agents.
Glede na farmakokinetične podatke pri sočasni uporabi fluvastatina in navedenih zdravil ni potrebno posebno spremljanje ali prilagajanje odmerjanja.
Oral antidiabetic agents
Peroralni antidiabetiki
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.
V veliki večini držav članic EU je zdravilo Lescol/Lescol XL kontraindicirano pri doječih materah.
Doses should be individualised according to baseline LDL-C levels and the recommended goal of therapy to be accomplished.
Odmerke je treba prilagoditi posameznemu bolniku glede na izhodiščne ravni LDL-C, da dosežemo priporočeni cilj zdravljenja.
What Lescol/Lescol XL contains - The active substance is fluvastatin sodium
Kaj vsebuje zdravilo Lescol/Lescol XL - Zdravilna učinkovina je natrijev fluvastatinat.
Fluvastatin is absorbed rapidly and completely (98%) after oral administration of a solution to fasted volunteers.
Po peroralni uporabi raztopine na tešče pri prostovoljcih se je fluvastatin hitro in popolnoma (98odstotno) absorbiral.
For patients requiring LDL-C reduction to a goal of ≥25%, the recommended starting dose is 40 mg as one capsule in the evening.
Za bolnike s ciljem ≥ 25-odstotnega znižanja ravni LDL-C je priporočeni začetni odmerek 40 mg v obliki ene kapsule zvečer.
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.
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.
No data are available for the use of fluvastatin in patients with the very rare condition of homozygous familial hypercholesterolaemia.
Glede uporabe fluvastatina pri bolnikih s homozigotno familiarno hiperholesterolemijo, ki je zelo redka bolezen, ni na voljo nobenih podatkov.
They are used in patients whose conditions cannot be controlled by diet and exercise alone.
Uporabljajo jih bolniki, pri katerih dieta in telesna vadba ne zadoščata za uravnavanje ravni maščob v krvi.
How to store Lescol/Lescol XL Further information
Shranjevanje zdravila Lescol/Lescol XL Dodatne informacije
Isolated cases of myopathy have been reported post-marketing for concomitant administration of fluvastatin with ciclosporin and fluvastatin with colchicines.
Po prihodu zdravila na trg so poročali o posameznih primerih miopatije pri bolnikih, ki so sočasno jemali fluvastatin s ciklosporinom ali fluvastatin s kolhicinom.
‘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.'
„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.“
Lescol and associated names (see Annex I) 20 mg capsules, hard
Lescol in povezana imena (glejte Dodatek I) 20 mg kapsule, trde
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
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).
Table 1 Adverse reactions
Preglednica 1 Neželeni učinki
Lescol/Lescol XL has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia.'
Zdravilo Lescol/Lescol XL je bilo raziskano le pri otrocih s heterozigotno družinsko hiperholesterolemijo, starih 9 let ali več.“
Immune system disorders Very rare:
Bolezni imunskega sistema zelo redki:
There is no experience with the use of Lescol in combination with nicotinic acid, cholestyramine or fibrates in children and adolescents.
O uporabi zdravila Lescol v kombinaciji z nikotinsko kislino, s holestiraminom ali s fibrati pri otrocih in mladostnikih ni nobenih izkušenj.
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).
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).
90429 Nürnberg, Germany
90429 Nürnberg Nemčija
- 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.
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.
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.
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.
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.
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%.
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).
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).
- if you are allergic (hypersensitive) to fluvastatin or any of the other ingredients of Lescol/Lescol XL
Ne jemljite zdravila Lescol/Lescol XL - če ste alergični (preobčutljivi) na fluvastatin ali katerokoli sestavino zdravila Lescol/Lescol XL,
If muscular symptoms like pain, weakness or cramps occur in patients receiving fluvastatin, their CK levels should be measured.
Če se pri bolnikih, ki prejemajo fluvastatin, pojavijo mišični simptomi, na primer bolečina, oslabelosti ali mišični krči, je treba določiti vrednost kreatin-kinaze.
• Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1).
• Sekundarno preprečevanje poglavitnih srčnih dogodkov pri odraslih bolnikih s koronarno srčno boleznijo po perkutanih koronarnih intervencijskih posegih (glejte poglavje 5.1).
Lescol/Lescol XL has not been investigated and is not intended for the use in children below 9 years.
Zdravilo Lescol/Lescol XL in otroci/mladostniki Zdravila Lescol/Lescol XL niso proučevali pri otrocih, mlajših od 9 let, in ni namenjeno takim otrokom.
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
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
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.
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.
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).
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).
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.
Največji dnevni odmerek je 80 mg v obliki zdravila Lescol kapsule 40 mg dvakrat dnevno ali zdravila Lescol 80 mg tablete enkrat dnevno.
Lescol XL and associated names (see Annex I) 80 mg prolonged-release tablets
Lescol XL in povezana imena (glejte Dodatek I) 80 mg tablete s podaljšanim sproščanjem
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.
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 %.
Marked elevations of CK levels to more than 5x ULN developed in a very small number of patients (0.3 to 1.0%).
Pri zelo majhnem številu bolnikov (0,3 do 1,0 %) je prišlo do izrazitega zvišanja vrednost kreatin-kinaze na več kot 5kratno ZMN.
Common: affects 1 to 10 users in 100
Pogosti: pojavijo se pri 1 do 10 od 100 uporabnikov.
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.
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.
• 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.
• 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.
• Renal impairment.
• ledvična okvara,
Vascular disorders Very rare:
Žilne bolezni zelo redki:
SANDOZ S.p.A Address: Largo Umberto Boccioni 1
SANDOZ S.p.A Largo Umberto Boccioni 1 I-21040 Origgio / VA Italija
Lescol MR 80 mg - Filmtabletten
Lescol MR 80 mg - Filmtabletten80 mg filmsko obložena tableta peroralna uporaba
Rare: affects 1 to 10 users in 10,000
Redki: pojavijo se pri 1 do 10 od 10.000 uporabnikov.
• Secondary prevention of major cardiac events in adults with coronary heart disease (CHD)
• Sekundarno preprečevanje poglavitnih srčnih dogodkov pri odraslih bolnikih s koronarno srčno boleznijo (CHD) po perkutanih koronarnih intervencijskih posegih (PCI)
If you are pregnant, consult your doctor or pharmacist before taking Lescol/Lescol XL.
Če ste noseči, se pred začetkom uporabe zdravila Lescol/Lescol XL posvetujte z zdravnikom ali s farmacevtom.
If you forget to take Lescol/Lescol XL
Če ste pozabili vzeti zdravilo Lescol/Lescol XL
BATCH NUMBER [To be completed Nationally]
ŠTEVILKA SERIJE [Izpolni država članica]
BEFORE YOU TAKE LESCOL/LESCOL XL Follow all instructions given to you by your doctor carefully.
Pri jemanju zdravila Lescol/Lescol XL natančno upoštevajte zdravnikova navodila.
Read all of this leaflet carefully before you start using this medicine.
Pred začetkom jemanja natančno preberite navodilo!
If you become pregnant while taking this medicine, stop taking Lescol/Lescol XL and see your doctor.
Če zanosite v času jemanja zdravila Lescol/Lescol XL, prenehajte jemati zdravilo in obiščite zdravnika.
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
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
Novartis Pharma B.V. P.O.
Nizozemska Novartis Pharma B.V.
Kasou 21, 1086 Nicosia, Cyprus
Demetriades & Papaellinas Ltd. Kasou 21, 1086 Nicosia Ciper
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).
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).
Each Lescol 40 mg capsule contains 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid.
Ena kapsula Lescol 40 mg vsebuje 42,12 mg natrijevega fluvastatinata, kar ustreza 40 mg proste kisline fluvastatina.
No clinically significant pharmacokinetic interactions occur when fluvastatin is concomitantly administered with propranaolol, digoxin, losartan or amlodipine.
Pri sočasni uporabi fluvastatina s propranololom, digoksinom, losartanom ali amlodipinom ne prihaja do klinično pomembnih farmakokinetičnih interakcij.
Each Lescol XL 80 mg tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid.
Ena tableta Lescol XL 80 mg tablet vsebuje 84,24 mg natrijevega fluvastatinata, kar ustreza 80 mg proste kisline fluvastatina.
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.
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.
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.
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.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex 1 - To be completed nationally]
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - Izpolni država članica]
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).
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.
Each Lescol 20 mg capsule contains 21.06 mg fluvastatin sodium equivalent to 20 mg fluvastatin free acid.
Ena kapsula Lescol 20 mg vsebuje 21,06 mg natrijevega fluvastatinata, kar ustreza 20 mg proste kisline fluvastatina.