natgillin/translations-raw huggingface dataset:
For dose information in children and adolescents over 9 years, see section 3.
Za podatke o odmerjanju pri otrocih in mladostnikih, ki so starejši od 9 let, glejte poglavje
Skeletal muscle
Skeletne mišice
Swallow whole with a glass of water.
Zaužiti jih je treba cele s kozarcem vode.
Following administration of 3H-fluvastatin to healthy volunteers, excretion of radioactivity is about 6% in the urine and 93% in the faeces, and fluvastatin accounts for less than 2% of the total radioactivity excreted.
Po vnosu 3H-fluvastatina zdravim prostovoljcem se okrog 6 % radioaktivnosti izloči v urinu in okrog 93 % v blatu, fluvastatin pa predstavlja manj kot 2 % celotne izločene radioaktivnosti.
No data are available about the physical, intellectual and sexual maturation for prolonged treatment period.
Za daljša obdobja zdravljenja ni na voljo nobenih podatkov o telesnem, umskem in spolnem dozorevanju.
In this randomised, double-blind, controlled clinical study, 429 patients were treated with either fluvastatin 40 mg/day or placebo.
V tej randomizirani, dvojno slepi, kontrolirani klinični študiji je 429 bolnikov prejemalo bodisi fluvastatin 40 mg/dan ali placebo.
Pharmacotherapeutic group: HMG-CoA reductase inhibitors, ATC code: C10A A04
Farmakoterapevtska skupina: zaviralci reduktaze HMG-CoA, oznaka ATC: C10AA04
Section 4.7 - Effects on ability to drive and use machines A statement that no studies on the effects on the ability to drive and use machines have been performed has been included.
Poglavje 4.7 - Vpliv na sposobnost vožnje in upravljanja s stroji Vključena je bila izjava, da študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
Plasma concentrations of fluvastatin do not vary as a function of either age or gender in the general population.
Koncentracija fluvastatina v plazmi se pri splošni populaciji ne spreminja niti s starostjo niti s spolom.
If you are taking Lescol XL tablets you can take your dose at any time of the day.
Če jemljete tablete Lescol XL, lahko vzamete odmerek kadarkoli preko dneva.
The MAH Novartis completed the EU Work Sharing Project on paediatric wording on 24 July 2007.
Imetnik dovoljenja za promet z zdravilom, družba Novartis, je 24. julija 2007 zaključila projekt „EU Work Sharing Project“ o besedilih za pediatrično rabo.
- if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
- če imate trenutno težave z jetri ali nepojasnjeno trajno zvišane ravni določenih jetrnih encimov
• Primary hypercholesterolaemia and mixed dyslipidaemia Starting dose recommendation
• Primarna hiperholesterolemija in mešana dislipidemija Priporočeni začetni odmerek
The following adverse events have been reported with some statins:
Pri uporabi nekaterih statinov so poročali o naslednjih neželenih dogodkih:
- If you have any further questions, ask your doctor or pharmacist.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
The particular reference to heart transplant conditions and ciclosporin seems sufficiently covered by the general statement for immunosuppressive drugs.
Posebna izpostavitev stanja po presaditvi srca in ciklosporinov v splošni izjavi glede imunosupresivnih zdravil se zdi zadostna.
In this study there were no changes in glucose, insulin, and C-peptide levels.
V tej študiji ni prišlo do sprememb koncentracij glukoze, insulina in C-peptida.
6.6 Special precautions for disposal <and other handling> No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
Paraesthesia, dysaesthesia, hypoaesthesia also known to be associated with the underlying hyperlipidaemic disorders
parestezije, dizestezija, hipestezija, za katero je tudi znano, da je povezana z osnovnimi hiperlipidemičnimi boleznimi
Metamorphosis GR-144 51 Athens, Greece
GR-144 51 Athens Grčija
Other possible side effects - Sleep disturbances, including insomnia and nightmares - Memory loss - Sexual difficulties - Depression - Breathing problems including persistent cough and/or shortness of breath or fever
Drugi možni neželeni učinki: - motnje spanja, med drugim nespečnost in nočne more - izguba spomina - težave v spolnosti - depresija - težave pri dihanju, med drugim trdovraten kašelj in/ali zadihanost ali zvišana telesna temperatura
Since no new data was submitted during this harmonisation referral, the CHMP confirmed that a paediatric indication could not be granted during this Article 30 harmonisation referral.
Ker med tem napotitvenem postopku zaradi usklajevanja novi podatki niso bili predloženi, je CHMP potrdil, da pediatrične indikacije ni mogoče odobriti v tem napotitvenem postopku zaradi usklajevanja v skladu s členom 30.
This result was independent of baseline total cholesterol levels.
Ta rezultat je bil neodvisen od izhodiščne ravni skupnega holesterola.
Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne France
Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne Francija
If you are taking Lescol twice per day, take one capsule in the morning and one in the evening or at bedtime.
Če jemljete zdravilo Lescol dvakrat na dan, vzemite eno kapsulo zjutraj in eno zvečer ali pred spanjem.
− in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
− pri odraslih bolnikih, ki imajo zvišano raven tako holesterola kot trigliceridov (ki so še ena vrsta lipidov v krvi).
The dosage recommendations in elderly patients are consistent across the Member States in stating that no dose adjustments are required.
Priporočila o odmerjanju pri starostnikih so skladna v državah članicah, saj določajo, da prilagajanje odmerka ni potrebno.
There is no obvious reason therefore, to contraindicate doses>40mg in severe renal impairment, but it would be more appropriate to initiate these high doses with caution.
Zato ni jasnih razlogov za kontraindikacijo odmerkov > 40 mg pri bolnikih s hudo okvarjenim delovanjem ledvic, vendar bi bilo primernejše uvajati te visoke odmerke s previdnostjo.
Active substance: fluvastatin (as fluvastatin sodium)
Zdravilna učinkovina: fluvastatin (v obliki natrijevega fluvastatinata)
Lescol IR (Lescol immediate release) 20 mg and 40 mg capsules were first registered in 1993.
Zdravilo Lescol IR (Lescol s takojšnjim sproščanjem) 20 mg in 40 mg kapsule so prvič registrirali leta 1993.
During the procedure, the MAH was requested to summarise this section, describing the results of the preclinical studies in brief and qualitative statements, according to the Guideline on the Summary of Product Characteristics.
Med postopkom je bil imetnik dovoljenja za promet z zdravilom naprošen, da pripravi povzetek tega poglavja, v katerem bodo na kratko opisani rezultati predkliničnih študij in izjave o kakovosti v skladu s Smernicami o povzetku glavnih značilnosti zdravila.
Furthermore, no paediatric indication was granted through the EU Paediatric Worksharing project and no new clinical data were submitted for this Art 30 procedure.
Poleg tega v okviru projekta „EU Paediatric Worksharing project“ niso bile odobrene pediatrične indikacije in po tem postopku v skladu s členom 30 niso bili predloženi novi klinični podatki.
However, patients on concomitant therapy with glibenclamide (glyburide) and fluvastatin should continue to be monitored appropriately when their fluvastatin dose is increased to 80 mg per day.
Kljub temu pa je treba bolnike, ki sočasno jemljejo glibenklamid (gliburid) in fluvastatin, še naprej ustrezno spremljati pri zvišanju odmerka fluvastatina na 80 mg na dan.
Bulgaria, Estonia, Hungary, Slovenia
Bolgarija, Estonija, Madžarska, Slovenija
Considering the possibility of teratogenicity with statins as a class, the benefit risk for the use in pregnancy has been considered as negative for statins including fluvastatin and the contraindication in pregnancy justified.
Ker obstaja možnost teratogenosti statinov kot skupine, se razmerje med koristmi in tveganji statinov, vključno s fluvastatinom, pri uporabi v nosečnosti šteje za negativnega, kontraindikacija v nosečnosti pa za upravičeno.
More than 98% of the circulating drug is bound to plasma proteins, and this binding is not affected either by the concentration of fluvastatin, or by warfarin, salicylic acid or glyburide.
Več kot 98 % zdravila v krvi je vezanega na plazemske beljakovine, na to vezavo pa ne vplivajo niti koncentracija fluvastatina niti varfarin, salicilna kislina ali gliburid.
This is also in line with all other statins posology recommendations.
To je tudi v skladu z drugimi priporočili o odmerjanju statinov.
Do not take a double dose to make up for the one that you missed.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Fluvastatin exerts its main effect in the liver and is mainly a racemate of the two erythro enantiomers of which one exerts the pharmacological activity.
Fluvastatin učinkuje predvsem v jetrih in je v glavnem racemat dveh eritroenantiomer, od katerih je ena farmakološko aktivna.
• in patients with known hypersensitivity to fluvastatin or any of the excipients.
• pri bolnikih z znano preobčutljivostjo za fluvastatin ali katerokoli pomožno snov;
Further toxicity seen in animals was either not relevant for human use or occurred at exposure levels sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Dodatne ugotovitve toksičnosti pri živalih bodisi niso bile pomembne za uporabo pri človeku bodisi so se pojavile pri izpostavljenosti, ki je zadostno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
The CHMP also agreed with the MAH's proposal not to include a recommendation to assess causes of secondary hypercholesterolaemia in the indications section.
CHMP se je strinjal tudi s predlogom imetnika dovoljenja za promet z zdravilom, da se v poglavje o indikacijah ne vključi priporočilo o ocenjevanju vzrokov sekundarne hiperholesterolemije.
Since fluvastatin is eliminated primarily via the biliary route and is subject to significant presystemic metabolism, the potential exists for drug accumulation in patients with hepatic insufficiency (see sections 4.3 and 4.4).
Ker se fluvastatin odstranjuje iz telesa primarno po žolčni poti in je izpostavljen precejšnjemu predsistemskemu metabolizmu, pri bolnikih z insuficienco jeter obstaja možnost kopičenja zdravila (glejte poglavji 4.3 in 4.4).
The undesirable effects currently listed are consistently represented in the SPCs of the EU Member States, except for anaphylactic reaction, which was recently included.
Trenutni seznam neželenih učinkov je dosledno prikazan v povzetkih glavnih značilnosti zdravila v državah članicah EU, razen za anafilaktično reakcijo, ki je bila dodana nedavno.
Lescol was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Zdravilo Lescol je bilo vključeno na seznam zdravil za usklajevanje povzetkov glavnih značilnosti zdravila, ki ga je pripravila Koordinacijska skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
The CHMP agreed that the proposed starting dose of 40 mg in patients requiring LDL-C reductions of ≥25% is justified by the clinical data provided.
CHMP se je strinjal, da je priporočeni začetni odmerek 40 mg pri bolnikih, ki potrebujejo ≥ 25odstotno znižanje ravni LDL-C, utemeljen na podlagi predloženih kliničnih podatkov.
Despite the potential that therefore exists for competitive interaction between fluvastatin and compounds that are CYP2C9 substrates, such as diclofenac, phenytoin, tolbutamide and warfarin, clinical data indicate that this interaction is unlikely.
Kljub možnosti, ki potemtakem obstaja za kompetitivno medsebojno delovanje fluvastatina in spojin, ki so substrati CYP2C9, na primer diklofenak, fenitoin, tolbutamid in varfarin, klinični podatki kažejo, da je to medsebojno delovanje malo verjetno.
The plasma clearance (CL/f) for fluvastatin in man is calculated to be 1.8 ± 0.8 l/min.
Izračunan plazemski očistek (CL/f) za fluvastatin pri človeku znaša 1,8 ± 0,8 l/min.
The inhibition of cholesterol biosynthesis reduces the cholesterol in hepatic cells, which stimulates the synthesis of LDL receptors and thereby increases the uptake of LDL particles.
Zaviranje biosinteze holesterola zmanjšuje holesterol v jetrnih celicah, kar spodbuja sintezo receptorjev LDL in s tem povečuje privzem delcev LDL.
Other skin reactions (e.g. eczema, dermatitis, bullous exanthema), face oedema, angioedema Musculoskeletal and connective tissue disorders Rare:
druge kožne reakcije (na primer ekcem, dermatitis, bulozni eksantem), edem obraza, angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva redki:
2100 Kopenhagen Ø, Denmark
2100 Kopenhagen Ø Danska
Itraconazole and erythromycin
Itrakonazol in eritromicin
Marketing Authorisation Holder and Manufacturer For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec Za vse morebitne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom: [Glejte Dodatek I - Izpolni država članica]
Children and adolescents with heterozygous familial hypercholesterolaemia No pharmacokinetic data in children are available.
Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Ni podatkov o farmakokinetičnih lastnostih pri otrocih.
Based on the recommendation given by the CHMP, the following wording proposed was agreed: ‘Renal Impairment
Na podlagi priporočil CHMP je bilo sprejeto naslednje predlagano besedilo: „Okvarjeno delovanje ledvic
The major components circulating in the blood are fluvastatin and the pharmacologically inactive N-desisopropyl-propionic acid metabolite.
Poglavitni spojini, ki krožita po krvi, sta fluvastatin in farmakološko neaktivni presnovek N-desizopropil-propionska kislina.
Following the procedure the MAH submitted the approved paediatric wording to all EU member states.
Imetnik dovoljenja za promet z zdravilom je po tem postopku predložil odobreno besedilo za pediatrično rabo vsem državam članicam EU.
Dose adjustments should be made at intervals of 4 weeks or more.'
Odmerek je zato treba prilagajati v presledkih po 4 tedne ali več.“
- For children (aged 9 years and older) the usual starting dose is 20 mg per day.
- Običajni začetni odmerek za otroke (stare 9 let ali starejše) je 20 mg na dan.
Despite the theoretical considerations concerning the role of cholesterol in embryo development, animal studies did not suggest an embryotoxic and teratogenic potential of fluvastatin.'
Kljub teoretični razpravi o vlogi holesterola pri razvoju zarodka, študije živali niso nakazale embriotoksičnega ali teratogenega potenciala fluvastatina.“
Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR,
Frimley Business Park Frimley, Camberley Surrey GU16 7SR Velika Britanija
Demark, Finland, Iceland, Norway, Sweden
Danska, Finska, Islandija, Norveška, Švedska
Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
Novartis Farmacéutica S.A. Gran Via de les Corts Catalanas, N° 764, 08013 Barcelona Španija
Lescol/ Lescol XL will not cure your condition but it does help control it.
Zdravilo Lescol/Lescol XL ne bo ozdravilo vaše bolezni, pomaga pa jo urejati.
Novartis Norge AS, Postboks 237 Økern, 0510 Oslo, Norway
Novartis Norge AS Postboks 237 Økern 0510 Oslo Norveška
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.
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.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba.
Women of childbearing potential have to use effective contraception.
Ženske v rodni dobi morajo uporabljati učinkovita sredstva za preprečevanje nosečnosti.
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.
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.
Section 5.2 - Pharmacokinetic properties The CHMP agreed with the wording proposed by the MAH.
Poglavje 5.2 - Farmakokinetične lastnosti CHMP se je strinjal z besedilom, ki ga je predlagal imetnik dovoljenja za promet z zdravilom:
For the secondary CHD prevention indication in patients after transcatheter therapy/PCI, a dose of 80 mg was generally proposed as adequate.
Za indikacijo sekundarnega preprečevanja CHD pri bolnikih po transkatetrski terapiji/PCI se je odmerek 80 mg na splošno štel za zadostnega.
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.
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.
Fluvastatin has only been investigated in children of 9 years and older with heterozygous familial hypercholesterolaemia (for details see section 5.1).
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).
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.
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.
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.
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.
Patients should therefore be advised to promptly report unexplained muscle pain, muscle tenderness or muscle weakness, particularly if accompanied by malaise or fever.
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.
After intake of a resin, e.g. cholestyramine (primarily used to treat high cholesterol) wait at least 4 hours before taking Lescol/Lescol XL.
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.
If you experience any of these, tell your doctor straight away.
Če se pri vas pojavi kateri od zgoraj navedenih učinkov, takoj sporočite zdravniku.
- 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.
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Therefore, Lescol/Lescol XL is contraindicated during pregnancy (see section 4.3).
Zato je zdravilo Lescol/Lescol XL med nosečnostjo kontraindicirano (glejte poglavje 4.3).
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.
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.
Your doctor will tell you exactly how many capsules or tablets of Lescol/Lescol XL to take.
Vaš zdravnik vam bo natančno povedal, koliko kapsul oziroma tablet zdravila Lescol/Lescol XL morate jemati.
The incidence of MACE was 21.4% on fluvastatin and 26.7% on placebo.
Pojavnost MACE je bila 21,4 % v skupini bolnikov, ki so prejemali fluvastatin, in 26,7 % v skupini bolnikov, ki so prejemali placebo.
Fluvastatin is mainly metabolised in the liver.
Fluvastatin se presnavlja predvsem v jetrih.
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.
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.
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.
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.
Myositis and rhabdomyolysis have been reported very rarely.
O miozitisu in rabdomiolizi so poročali zelo redko.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
• Previous history of muscular toxicity with a statin or fibrate.
• anamneza prejšnje toksičnosti za mišice katerega izmed statinov ali fibratov,
Although these increases in fluvastatin levels were not clinically significant, this combination should be used with caution.
Čeprav to zvišanje koncentracije fluvastatina ni bilo klinično pomembno, je pri uporabi te kombinacije zdravil potrebna previdnost.
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.
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.