FrancophonIA/ELRC3.0 huggingface dataset:
English: Despite the theoretical considerations concerning the role of cholesterol in embryo development, animal studies did not suggest an embryotoxic and teratogenic potential of fluvastatin.'
Slovenian: Kljub teoretični razpravi o vlogi holesterola pri razvoju zarodka, študije živali niso nakazale embriotoksičnega ali teratogenega potenciala fluvastatina.“
English: Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR,
Slovenian: Frimley Business Park Frimley, Camberley Surrey GU16 7SR Velika Britanija
English: Demark, Finland, Iceland, Norway, Sweden
Slovenian: Danska, Finska, Islandija, Norveška, Švedska
English: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Slovenian: Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013 Barcelona Španija
English: Lescol/ Lescol XL will not cure your condition but it does help control it.
Slovenian: Zdravilo Lescol/Lescol XL ne bo ozdravilo vaše bolezni, pomaga pa jo urejati.
English: Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway
Slovenian: Novartis Norge AS Postboks 237 Økern 0510 Oslo Norveška
English: Based on the Cox regression analysis the risk ratio for MACE was estimated at 0.78, equivalent to a statistically significant 22% reduction in the risk of MACE for patients treated in the Lescol group compared to the placebo group.
Slovenian: Na podlagi Coxove regresijske analize so ocenili razmerje tveganja za dogodke MACE 0,78, kar je ustrezalo statistično precejšnjemu 22-odstotnemu znižanju tveganja za dogodke MACE pri bolnikih, ki so prejemali zdravilo Lescol, v primerjavi z bolniki, ki so prejemali placebo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
English: Women of childbearing potential have to use effective contraception.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovita sredstva za preprečevanje nosečnosti.
English: After oral administration of Lescol XL, and in comparison with the capsules, the absorption rate of fluvastatin is almost 60% slower while the mean residence time of fluvastatin is increased by approximately 4 hours.
Slovenian: Po peroralni uporabi zdravila Lescol XL je v primerjavi s kapsulami hitrost absorpcije fluvastatina skoraj 60 % počasnejša, medtem ko se povprečni čas zadrževanja fluvastatina v prebavilih podaljša za približno 4 ure.
English: Section 5.2 - Pharmacokinetic properties The CHMP agreed with the wording proposed by the MAH.
Slovenian: Poglavje 5.2 - Farmakokinetične lastnosti CHMP se je strinjal z besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
English: For the secondary CHD prevention indication in patients after transcatheter therapy/PCI, a dose of 80 mg was generally proposed as adequate.
Slovenian: Za indikacijo sekundarnega preprečevanja CHD pri bolnikih po transkatetrski terapiji/PCI se je odmerek 80 mg na splošno štel za zadostnega.
English: The MAH's proposal to include response to diet and other measures (e.g. exercise, weight reduction) was also considered to be acceptable as it is in line with other statin product information texts.
Slovenian: Odbor je tudi predlog imetnika dovoljenja za promet z zdravilom o vključitvi odziva na dieto in druge ukrepe (npr. telesno vadbo, znižanje telesne mase) štel za sprejemljivega, saj je skladen z drugimi besedili informacij o statinih.
English: Fluvastatin has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia (for details see section 5.1).
Slovenian: Uporaba fluvastatina je bila raziskana samo pri otrocih, ki so bili stari vsaj 9 let in so imeli heterozigotno familiarno hiperholesterolemijo (za podrobnosti glejte poglavje 5.1).
English: The CHMP was of the opinion that the data submitted by the MAH intended to support the indication “Lescol/Lescol XL is indicated to slow the progression of coronary atherosclerosis in adults with primary hypercholesterolaemia and coronary heart disease” was not clinically meaningful and therefore a positive benefit/risk could not be established.
Slovenian: CHMP je menil, da podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom v podporo indikaciji „Zdravilo Lescol/Lescol XL je indicirano za upočasnitev napredovanja koronarne ateroskleroze pri odraslih bolnikih s primarno hiperholesterolemijo in koronarno srčno boleznijo“, niso klinično pomembni, zato razmerje med koristmi in tveganji ni bilo pozitivno.
English: A summary of the clinical trial data from the Lipoprotein and Coronary Atherosclerosis Study (LCAS) has been proposed by the MAH, including a statement that the significance of angiographic findings was not known.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil povzetek podatkov kliničnega preskušanja „Lipoprotein and Coronary Atherosclerosis Study“ (LCAS), vključno z izjavo, da pomen angiografskih odkritij ni znan.
English: Patients should therefore be advised to promptly report unexplained muscle pain, muscle tenderness or muscle weakness, particularly if accompanied by malaise or fever.
Slovenian: Zato je treba bolnikom svetovati, da takoj sporočijo, če se pojavijo nepojasnjene bolečine v mišicah, občutljivost ali oslabelost mišic, zlasti če navedeno spremlja še splošno slabo počutje ali zvišana telesna temperatura.
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.
Slovenian: Po zaužitju smole, na primer holestiramina (ki jo uporabljamo predvsem za zniževanje previsoke ravni holesterola), počakajte vsaj 4 ure, preden vzamete zdravilo Lescol/Lescol XL.
English: If you experience any of these, tell your doctor straight away.
Slovenian: Če se pri vas pojavi kateri od zgoraj navedenih učinkov, takoj sporočite zdravniku.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Therefore, Lescol/Lescol XL is contraindicated during pregnancy (see section 4.3).
Slovenian: Zato je zdravilo Lescol/Lescol XL med nosečnostjo kontraindicirano (glejte poglavje 4.3).
English: There is consistency across all EU Member States in contraindicating Lescol/Lescol XL for patients with known hypersensitivity to fluvastatin or any of the excipients and in patients with active liver disease, or unexplained, persistent elevations in serum transaminases.
Slovenian: Obstaja doslednost v vseh državah članicah EU glede kontraindikacije zdravila Lescol/Lescol XL pri bolnikih z znano preobčutljivostjo za fluvastatin ali katero koli pomožno snov in pri bolnikih z aktivno jetrno boleznijo ali perzistentnim zvišanjem serumskih transaminaz brez dokazanega vzroka.
English: Your doctor will tell you exactly how many capsules or tablets of Lescol/Lescol XL to take.
Slovenian: Vaš zdravnik vam bo natančno povedal, koliko kapsul oziroma tablet zdravila Lescol/Lescol XL morate jemati.
English: The incidence of MACE was 21.4% on fluvastatin and 26.7% on placebo.
Slovenian: Pojavnost MACE je bila 21,4 % v skupini bolnikov, ki so prejemali fluvastatin, in 26,7 % v skupini bolnikov, ki so prejemali placebo.
English: Fluvastatin is mainly metabolised in the liver.
Slovenian: Fluvastatin se presnavlja predvsem v jetrih.
English: As with other lipid-lowering agents, it is recommended that liver function tests be performed before the initiation of treatment and at 12 weeks following initiation of treatment or elevation in dose and periodically thereafter in all patients.
Slovenian: Kot pri drugih zdravilih, ki zmanjšujejo koncentracijo lipidov v krvi, je pri vseh bolnikih priporočljivo opraviti teste jetrne funkcije pred začetkom zdravljenja, 12 tednov po začetku zdravljenja ali po zvišanju odmerka in občasno tudi kasneje.
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.
Slovenian: Ker zaviralci reduktaze HMG-CoA zmanjšujejo sintezo holesterola in morda tudi sintezo drugih biološko aktivnih snovi, ki izhajajo iz holesterola, bi lahko škodovali plodu, če bi jih jemale nosečnice.
English: Myositis and rhabdomyolysis have been reported very rarely.
Slovenian: O miozitisu in rabdomiolizi so poročali zelo redko.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: • Previous history of muscular toxicity with a statin or fibrate.
Slovenian: • anamneza prejšnje toksičnosti za mišice katerega izmed statinov ali fibratov,
English: Although these increases in fluvastatin levels were not clinically significant, this combination should be used with caution.
Slovenian: Čeprav to zvišanje koncentracije fluvastatina ni bilo klinično pomembno, je pri uporabi te kombinacije zdravil potrebna previdnost.
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.
Slovenian: Zaradi heterogenosti pri predstavitvi podatkov kliničnega preskušanja o dislipidemiji iz raznih držav članic je bil predlagan jedrnat pristop z vključitvijo podatkov o zdravilu Lescol IR iz združenih študij, kontroliranih s placebom, in podatkov iz programa razvoja zdravila Lescol XL.
English: Should the symptoms resolve and CK levels return to normal, then re-introduction of fluvastatin or another statin may be considered at the lowest dose and under close monitoring.
Slovenian: Če simptomi izzvenijo in se vrednost kreatin-kinaze vrne na normalno vrednost, presodite o ponovni uvedbi fluvastatina ali drugega statina v najnižjem odmerku in ob natančnem spremljanju.
English: • Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4)
Slovenian: • izjemoma primeri intersticijske pljučne bolezni, zlasti pri dolgotrajni uporabi statinov (glejte poglavje 4.4)
English: The ability of the trials to detect any effect of treatment in this area was however low.
Slovenian: Vendar pa sta imeli preskušanji le majhno moč za odkrivanje vpliva na omenjeni področji.
English: 70 patients were pubertal or postpubertal (n=69 evaluated for efficacy).
Slovenian: 70 bolnikov je bilo v pubertetnem oziroma v predpubertetnem obdobju (za presojo učinkovitosti zdravila so ocenili podatke 69 bolnikov).
English: A summary of the clinical trial data from the Lescol Intervention Prevention Study (LIPS) that is currently implemented in the largest number of Member States appeared most concise and was therefore proposed by the MAH.
Slovenian: Povzetek podatkov kliničnega preskušanja „Lescol Intervention Prevention Study“ (LIPS), ki trenutno velja v večini držav članic, se zdi najbolj zgoščen, zato ga je imetnik dovoljenja za promet z zdravilom predlagal.
English: − Your doctor can also prescribe Lescol/ Lescol XL to prevent further serious cardiac events (e.g. heart attack) in patients after they already went through a heart catheterisation, with an intervention in the heart vessel.
Slovenian: - Zdravnik lahko predpiše zdravilo Lescol/Lescol XL tudi za preprečevanje nadaljnjih resnih dogodkov povezanih s srcem (na primer srčnega infarkta) pri bolnikih po srčni kateterizaciji s posegom na kateri od srčnih žil.
English: Regarding section 5.3 Preclinical safety data, the MAH's proposal was amended and considered to be acceptable by the CHMP.
Slovenian: V zvezi s poglavjem 5.3 Predklinični podatki o varnosti je CHMP spremenil predlog imetnika dovoljenja za promet z zdravilom in ga nato štel za sprejemljivega.
English: ‘The maximum lipid-lowering effect with a given dose is achieved within 4 weeks.
Slovenian: „Največji učinek zniževanja ravni lipida pri danem odmerku dosežemo v 4 tednih.
English: Nevertheless, the available data suggest that no serious safety concern is present for Lescol as compared to placebo, for all renal function categories.
Slovenian: Vendar pa razpoložljivi podatki kažejo, da za zdravilo Lescol v primerjavi s placebom ni resnih zadržkov glede varnosti ne glede na kategorijo ledvične funkcije.
English: Rhabdomyolysis, myositis, lupus erythematosus-like reactions
Slovenian: rabdomioliza, miozitis, reakcije podobne lupusu eritematozusu
English: There are multiple, alternative cytochrome P450 (CYP450) pathways for fluvastatin biotransformation and thus fluvastatin metabolism is relatively insensitive to CYP450 inhibition.
Slovenian: Fluvastatin se s citokromom P450 (CYP 450) biotransformira na več različnih načinov, zato je metabolizem fluvastatina razmeroma neobčutljiv na zaviranje CYP 450.
English: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Malta, Norway, Netherlands, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom
Slovenian: Avstrija, Belgija, Ciper, Češka, Danska, Finska, Francija, Grčija, Islandija, Irska, Italija, Malta, Norveška, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Španija, Švedska, Velika Britanija
English: • in patients with active liver disease, or unexplained, persistent elevations in serum transaminases (see sections 4.2, 4.4 and 4.8).
Slovenian: • pri bolnikih z aktivno boleznijo jeter ali z nepojasnjenim trajnim zvišanjem vrednosti aminotransferaz v serumu (glejte poglavja 4.2, 4.4 in 4.8);
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvi pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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.
Slovenian: − Lescol/Lescol XL je zdravilo, ki ga pri odraslih uporabljamo za uravnavanje zvišane ravni maščob v krvi, zlasti ravni skupnega holesterola in tako imenovanega "slabega" oziroma LDL holesterola, ki je povezan s povečanim tveganjem za bolezni srca in možgansko kap.
English: No clinical data is available for Lescol in patients with homozygous familial hypercholesterolaemia (HoFH) and is stated in this section.
Slovenian: Kliničnih podatkov o zdravilu Lescol pri bolnikih s homozigotno družinsko hiperholesterolemijo (HoHF) ni, kar je tudi navedeno v tem poglavju.
English: Although at present there is no clinical evidence that fluvastatin efficacy in lowering lipid levels is altered, for patients undertaking long-term rifampicin therapy (e.g. treatment of tuberculosis), appropriate adjustment of fluvastatin dosage may be warranted to ensure a satisfactory reduction in lipid levels.
Slovenian: Čeprav zaenkrat ni kliničnih dokazov, da se vpliv fluvastatina na zniževanje koncentracij lipidov spremeni, bo lahko pri bolnikih, ki se dolgotrajno zdravijo z rifampicinom (na primer zaradi tuberkuloze), potrebna ustrezna prilagoditev odmerka fluvastatina, da bi lahko zagotovili zadostno zmanjšanje vrednosti lipidov.
English: Lescol/Lescol XL contains the active fluvastatin sodium which belongs to a group of medicines known as statins, which are lipid-lowering medicines: they lower the fat (lipids) in your blood.
Slovenian: Zdravilo Lescol/Lescol XL vsebuje aktivni natrijev fluvastatinat, ki sodi v skupino zdravil z imenom statini in so zdravila za zniževanje maščob: znižujejo raven maščob (lipidov) v krvi.
English: Given the minimal involvement of this enzyme in the metabolism of fluvastatin, it is expected that other CYP3A4 inhibitors (e.g. ketoconazole, ciclosporin) are unlikely to affect the bioavailability of fluvastatin.
Slovenian: Ker je ta encim minimalno vpleten v metabolizem fluvastatina, je malo verjetno pričakovati, da bodo drugi zaviralci CYP 3A4 (npr. ketokonazol, ciklosporin) vplivali na biološko uporabnost fluvastatina.
English: Studies in renal transplant patients indicate that the bioavailability of fluvastatin (up to 40 mg/day) is not elevated to a clinically significant extent in patients on stable regimens of ciclosporin.
Slovenian: Študije pri bolnikih po presaditvi ledvic kažejo, da se biološka uporabnost fluvastatina (v odmerkih do 40 mg/dan) ne poveča v klinično pomembni meri pri bolnikih, ki že ustaljeno prejemajo katero od shem s ciklosporinom.
English: The following wording proposed by the MAH was considered to be acceptable for the CHMP: ‘Lescol is efficacious in monotherapy.
Slovenian: CHMP je za sprejemljivo štel naslednje besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom: „Zdravilo Lescol je učinkovito pri monoterapiji.
English: In such situations, the risk of treatment should be considered in relation to the possible benefit and clinical monitoring is recommended.
Slovenian: V takih razmerah je treba pretehtati tveganje zdravljenja glede na možno korist.
English: Based on clinical observations, liver function tests are already recommended (see section 4.4).
Slovenian: Določanje testov jetrne funkcije je priporočeno že na osnovi kliničnih opažanj (glejte poglavje 4.4).
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.
Slovenian: Pri bolnikih z nepojasnjenimi difuznimi mialgijami, občutljivostjo ali oslabelostjo mišic in/ali izrazitim zvišanjem vrednosti kreatin-kinaze (CK) je treba pomisliti na možnost miopatije, miozitisa ali rabdomiolize.
English: The benefit and the risk of concurrent treatment should be carefully weighed and these combinations should only be used with caution (see section 4.4).
Slovenian: Koristi in tveganja sočasnega zdravljenja je treba skrbno pretehtati, pri uporabi te kombinacije zdravil pa je potrebna previdnost (glejte poglavje 4.4).
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.
Slovenian: • Primarna hiperholesterolemija in mešana dislipidemija CHMP se je strinjal z imetnikom dovoljenja za promet z zdravilom, da v poglavju o indikacijah niso potrebne dodatne izjave o izključevanju določenih lipoproteinskih bolezni (npr. homozigotnih različic družinske hiperholesterolemije in drugih Fredricksonovih tipov s prevladujočo hipertrigliceridemijo ali sekundarnih oblik hiperholesterolemije).
English: Liver function tests and serum CK levels should be monitored.
Slovenian: Spremljati je treba teste jetrne funkcije in vrednost kreatin-kinaze v serumu.
English: Like all medicines, Lescol/Lescol XL can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Lescol/Lescol XL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Presenting features can include dyspnoea, non productive cough and deterioration in general health (fatigue, weight loss and fever).
Slovenian: Znaki lahko vključujejo dispnejo, neproduktiven kašelj in poslabšanje splošnega stanja (utrujenost, zmanjšanje telesne mase in zvišano telesno temperaturo).
English: The results from another study in which Lescol XL tablets (80 mg fluvastatin) was administered to renal transplant patients who were on stable ciclosporin regimen showed that fluvastatin exposure (AUC) and maximum concentration (Cmax) were increased 2-fold compared to historical data in healthy subjects.
Slovenian: Rezultati druge študije, v kateri so dajali tablete Lescol XL (80 mg fluvastatina) po presaditvi ledvic bolnikom, ki so že ustaljeno prejemali katero od shem s ciklosporinom, so pokazali, da sta se pri teh bolnikih izpostavljenost fluvastatinu (AUC) in najvišja koncentracija fluvastatina (Cmax) zvišali za dvakrat v primerjavi z znanimi podatki pri zdravih ljudeh.
English: Since the available data suggest that there is no serious safety concern for Lescol as compared to placebo, for all renal function categories, the CHMP agreed that doses of >40mg in severe renal impairment would not be contraindicated, but that it would be necessary to initiate these high doses with caution.
Slovenian: Ker razpoložljivi podatki kažejo, da v nobeni kategoriji ledvične funkcije ni resnih varnostnih zadržkov za uporabo zdravila Lescol v primerjavi s placebom, CHMP meni, da se odmerki > 40 mg pri bolnikih s hudo okvarjenim delovanjem ledvic ne kontraindicirajo, ampak je potrebna previdnost pri uvajanju tako velikih odmerkov.
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.
Slovenian: Pri zdravih prostovoljcih uporaba fluvastatina in varfarina (v enkratnem odmerku) v primerjavi z uporabo samo varfarina ni neugodno vplivala na koncentracijo varfarina v plazmi in na protrombinski čas.
English: Fluvastatin exerts its main effect in the liver, which is also the main organ for its metabolism.
Slovenian: Fluvastatin deluje predvsem v jetrih, ki so tudi glavni organ njegove presnove.
English: − in adult patients with high blood levels of cholesterol
Slovenian: − pri odraslih bolnikih, ki imajo zvišano raven holesterola,
English: Lescol/Lescol XL is cleared by the liver, with less than 6% of the administered dose excreted into the urine.
Slovenian: Zdravilo Lescol/Lescol XL očistijo jetra, pri čemer se manj kot 6 % uporabljenega odmerka izloči v urinu.
English: The risk of myopathy has been reported to be increased in patients receiving immunosuppressive agents (including ciclosporin), fibrates, nicotinic acid or erythromycin together with other HMG-CoA reductase inhibitors.
Slovenian: Poročali so, da je tveganje za nastanek miopatije večje pri bolnikih, ki so prejemali imunosupresivna zdravila (vključno s ciklosporinom), fibrate, nikotinsko kislino ali eritromicin sočasno z drugimi zaviralci reduktaze HMG-CoA.
English: Lescol/Lescol XL can be taken on its own or with other cholesterol-lowering medicines prescribed by your doctor.
Slovenian: Zdravilo Lescol/Lescol XL lahko jemljete samostojno ali skupaj z drugimi zdravili za zniževanje ravni holesterola, ki vam jih predpiše vaš zdravnik.
English: Myopathy has rarely been reported with fluvastatin.
Slovenian: Pri uporabi fluvastatina so redko poročali o miopatiji.
English: • In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis.
Slovenian: • pri starejših bolnikih (starih > 70 let) je treba glede na prisotnost drugih dejavnikov, ki povečujejo nagnjenost k rabdomiolizi, pretehtati v kolikšni meri je potrebno določanje vrednosti kreatin-kinaze.
English: Therefore it was the recommendation of the CHMP that the starting dose of 40mg uptitrated to 80mg/day, taking into account patient response would be more appropriate from an efficacy and safety perspective.
Slovenian: Zato je CHMP priporočil, da bi bilo z vidika učinkovitosti in varnosti primerneje, da se začetni odmerek 40 mg povečuje do 80 mg/dan ob upoštevanju bolnikovega odziva.
English: ITALFARMACO S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Slovenian: Viale Fulvio Testi, 330 20126 Milano Italija