FrancophonIA/ELRC3.0 huggingface dataset:
English: • during pregnancy and lactation (see section 4.6).
Slovenian: • med nosečnostjo in dojenjem (glejte poglavje 4.6).
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction Food interactions were restricted to grapefruit juice only.
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije z živili so bile omejene le na grenivkin sok.
English: - the Summary of Products Characteristics, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: • Personal or familial history of hereditary muscular disorders.
Slovenian: • osebna ali družinska anamneza dednih mišičnih bolezni,
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LESCOL AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LESCOL IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Section 4.4 - Special warnings and precautions for use The CHMP considered it reasonable to maintain the recommendations on liver function testing which have been implemented in clinical practice over the last decade(s), although routine monitoring of transaminases has been discouraged more recently by various experts.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi CHMP je menil, da je utemeljeno ohraniti priporočila glede preiskav jetrne funkcije, ki so bile uvedene v klinično prakso v zadnjem(-ih) desetletju(-ih), čeprav so različni strokovnjaki nedavno odsvetovali rutinsko spremljanje ravni transaminaz.
English: Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports.
Slovenian: Neželeni učinki (preglednica 1) so razvrščeni po skupinah glede na pogostnost, najpogostejši najprej, pri čemer je uporabljen naslednji dogovor: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (< 1/10.000), vključno s posameznimi primeri.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Slovenian: Če pride do prevelikega odmerjanja, je treba bolnika zdraviti simptomatsko in po potrebi uvesti podporne ukrepe.
English: Fibrates and niacin
Slovenian: Fibrati in niacin
English: The ultimate result of these mechanisms is a reduction in the plasma cholesterol concentration.
Slovenian: Končni rezultat teh mehanizmov je znižanje plazemske koncentracije holesterola.
English: The information that the study was conducted in patients after PCI was added.
Slovenian: Dodana je bila informacija, da je bila študija opravljena pri bolnikih po PCI.
English: The CHMP agreed with the wording proposed for the paediatric population in line with the wording agreed during the EU Worksharing Project.
Slovenian: CHMP se je strinjal s predlaganim besedilom za pediatrično populacijo, ki je v skladu z besedilom, dogovorjenim med projektom „EU Worksharing Project“.
English: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
Slovenian: 2 & 4, rue Lionel Terray 92500 Rueil Malmaison Cédex Francija
English: • Memory loss
Slovenian: • izguba spomina
English: A creatine kinase level should be measured before starting fluvastatin treatment in the following situations:
Slovenian: Vrednosti kreatinkinaze je treba določiti pred začetkom zdravljenja s fluvastatinom v naslednjih primerih:
English: The majority of patients with these abnormal biochemical findings were asymptomatic.
Slovenian: Večina bolnikov, pri katerih je prišlo do teh nenormalnih biokemičnih izvidov, je bila brez simptomov.
English: Your cholesterol levels need to be checked regularly to monitor your progress.
Slovenian: Zdravnik bo moral redno določati raven vašega holesterola, da bo lahko spremljal potek vaše bolezni.
English: The hydroxylated metabolites have pharmacological activity but do not circulate systemically.
Slovenian: Hidroksilirani presnovki so farmakološko aktivni, a ne krožijo sistemsko.
English: The CHMP agreed with the following wording for a flexible initial dosing of 40-80mg: ‘The recommended dosing range is 20 to 80 mg/day.
Slovenian: CHMP se je strinjal z naslednjim besedilom za fleksibilno začetno odmerjanje 40-80 mg: „Priporočeni razpon odmerkov je od 20 do 80 mg/dan.
English: Fluvastatin inhibited only the metabolism of compounds that are metabolised by CYP2C9.
Slovenian: Fluvastatin je zaviral samo metabolizem spojin, ki jih presnavlja CYP2C9.
English: Austria, Germany
Slovenian: Avstrija, Nemčija
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v državah članicah Evropskega gospodarskega prostora pridobilo dovoljenje za promet z naslednjimi imeni:
English: In very rare cases, possibly drug-related hepatitis was observed that resolved upon discontinuation of treatment.
Slovenian: V zelo redkih primerih so opažali hepatitis, ki bi lahko bil povezan z zdravilom in je po prekinitvi zdravljenja izzvenel.
English: Lescol is efficacious in monotherapy.
Slovenian: Zdravilo Lescol je učinkovito v monoterapiji.
English: Based on preclinical data, it is expected that fluvastatin is excreted into human milk.
Slovenian: Na osnovi predkliničnih podatkov je mogoče pričakovati, da se fluvastatin pri ljudeh izloča v materino mleko.
English: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italy
Slovenian: UCB PHARMA S.p.A Via Gadames, 57 20151 Milano Italija
English: U Nákladového nádraží 10, 13000 Prague 3, Czech Republic
Slovenian: U Nákladového nádraží 10 13000 Prague 3
English: However appropriate wording for the paediatric population were included in the sections agreed during the EU Worksharing procedure; sections 4.2, 4.4, 4.8, 5.1 and 5.2.
Slovenian: Vendar je bilo ustrezno besedilo za pediatrično populacijo vključeno v poglavja 4.2, 4.4, 4.8, 5.1 in 5.2, kakor je bilo dogovorjeno med projektom „EU Worksharing“.
English: In the case of pre-pubertal children, as experience is very limited in this group, the potential risks and benefits should be carefully evaluated before the initiation of treatment.
Slovenian: Glede na zelo omejen obseg izkušenj pri otrocih v predpubertetnem obdobju je treba pri njih pred začetkom zdravljenja skrbno pretehtati možna tveganja in koristi.
English: The risk ratios of cardiac death (RR 0.53) and cardiac death or nonfatal MI (RR 0.69) were also less than 1 but the study was not powered for these endpoints.
Slovenian: Razmerji tveganja za srčno smrt (RR 0,53) in srčno smrt ali MI brez smrtnega izida (RR 0,69) sta bili tudi pod 1, vendar študija ni bila dovolj močna za vrednotenje teh končnih točk.
English: Should an increase in aspartate aminotransferase or alanine aminotransferase exceed 3 times the upper limit of normal and persist, therapy should be discontinued.
Slovenian: Če se koncentracija aspartat-aminotransferaze (AST) ali alanin-aminotransferaze (ALT) zviša za več kot trikrat nad zgornjo mejo normalnih vrednosti in ostane zvišana, je treba zdravljenje prekiniti.
English: An overall recommendation to monitor liver function and CK levels seemed a reasonable approach considering that effects on liver and muscle may be generally expected in statin overdosage.
Slovenian: Skupno priporočilo za spremljanje jetrne funkcije in ravni kreatin kinaze se je zdelo kot razumen pristop glede na splošno pričakovane učinke na jetra in mišičje pri prevelikem odmerjanju statinov.
English: For dose information in children and adolescents over 9 years, see section 3.
Slovenian: Za podatke o odmerjanju pri otrocih in mladostnikih, ki so starejši od 9 let, glejte poglavje
English: Skeletal muscle
Slovenian: Skeletne mišice
English: Swallow whole with a glass of water.
Slovenian: Zaužiti jih je treba cele s kozarcem vode.
English: 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.
Slovenian: 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.
English: No data are available about the physical, intellectual and sexual maturation for prolonged treatment period.
Slovenian: Za daljša obdobja zdravljenja ni na voljo nobenih podatkov o telesnem, umskem in spolnem dozorevanju.
English: In this randomised, double-blind, controlled clinical study, 429 patients were treated with either fluvastatin 40 mg/day or placebo.
Slovenian: V tej randomizirani, dvojno slepi, kontrolirani klinični študiji je 429 bolnikov prejemalo bodisi fluvastatin 40 mg/dan ali placebo.
English: Pharmacotherapeutic group: HMG-CoA reductase inhibitors, ATC code: C10A A04
Slovenian: Farmakoterapevtska skupina: zaviralci reduktaze HMG-CoA, oznaka ATC: C10AA04
English: 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.
Slovenian: 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.
English: Plasma concentrations of fluvastatin do not vary as a function of either age or gender in the general population.
Slovenian: Koncentracija fluvastatina v plazmi se pri splošni populaciji ne spreminja niti s starostjo niti s spolom.
English: If you are taking Lescol XL tablets you can take your dose at any time of the day.
Slovenian: Če jemljete tablete Lescol XL, lahko vzamete odmerek kadarkoli preko dneva.
English: The MAH Novartis completed the EU Work Sharing Project on paediatric wording on 24 July 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom, družba Novartis, je 24. julija 2007 zaključila projekt „EU Work Sharing Project“ o besedilih za pediatrično rabo.
English: - if you currently have liver problems, or if you have unexplained, persistently high level of certain liver enzymes (transaminases).
Slovenian: - če imate trenutno težave z jetri ali nepojasnjeno trajno zvišane ravni določenih jetrnih encimov
English: • Primary hypercholesterolaemia and mixed dyslipidaemia Starting dose recommendation
Slovenian: • Primarna hiperholesterolemija in mešana dislipidemija Priporočeni začetni odmerek
English: The following adverse events have been reported with some statins:
Slovenian: Pri uporabi nekaterih statinov so poročali o naslednjih neželenih dogodkih:
English: - If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: The particular reference to heart transplant conditions and ciclosporin seems sufficiently covered by the general statement for immunosuppressive drugs.
Slovenian: Posebna izpostavitev stanja po presaditvi srca in ciklosporinov v splošni izjavi glede imunosupresivnih zdravil se zdi zadostna.
English: In this study there were no changes in glucose, insulin, and C-peptide levels.
Slovenian: V tej študiji ni prišlo do sprememb koncentracij glukoze, insulina in C-peptida.
English: 6.6 Special precautions for disposal <and other handling> No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: Paraesthesia, dysaesthesia, hypoaesthesia also known to be associated with the underlying hyperlipidaemic disorders
Slovenian: parestezije, dizestezija, hipestezija, za katero je tudi znano, da je povezana z osnovnimi hiperlipidemičnimi boleznimi
English: Metamorphosis GR-144 51 Athens, Greece
Slovenian: GR-144 51 Athens Grčija
English: 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
Slovenian: 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
English: 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.
Slovenian: 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.
English: This result was independent of baseline total cholesterol levels.
Slovenian: Ta rezultat je bil neodvisen od izhodiščne ravni skupnega holesterola.
English: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne France
Slovenian: Pierre FABRE MEDICAMENT 45, place Abel Gance 92100 Boulogne Francija
English: If you are taking Lescol twice per day, take one capsule in the morning and one in the evening or at bedtime.
Slovenian: Če jemljete zdravilo Lescol dvakrat na dan, vzemite eno kapsulo zjutraj in eno zvečer ali pred spanjem.
English: − in adult patients with high blood levels of both cholesterol and triglycerides (another sort of blood lipid)
Slovenian: − pri odraslih bolnikih, ki imajo zvišano raven tako holesterola kot trigliceridov (ki so še ena vrsta lipidov v krvi).
English: The dosage recommendations in elderly patients are consistent across the Member States in stating that no dose adjustments are required.
Slovenian: Priporočila o odmerjanju pri starostnikih so skladna v državah članicah, saj določajo, da prilagajanje odmerka ni potrebno.
English: 6800 LZ Arnhem The Netherlands
Slovenian: 6800 LZ Arnhem
English: 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.
Slovenian: 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.
English: Active substance: fluvastatin (as fluvastatin sodium)
Slovenian: Zdravilna učinkovina: fluvastatin (v obliki natrijevega fluvastatinata)
English: Lescol IR (Lescol immediate release) 20 mg and 40 mg capsules were first registered in 1993.
Slovenian: Zdravilo Lescol IR (Lescol s takojšnjim sproščanjem) 20 mg in 40 mg kapsule so prvič registrirali leta 1993.
English: 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.
Slovenian: 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.
English: Furthermore, no paediatric indication was granted through the EU Paediatric Worksharing project and no new clinical data were submitted for this Art 30 procedure.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Bulgaria, Estonia, Hungary, Slovenia
Slovenian: Bolgarija, Estonija, Madžarska, Slovenija
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: This is also in line with all other statins posology recommendations.
Slovenian: To je tudi v skladu z drugimi priporočili o odmerjanju statinov.
English: Do not take a double dose to make up for the one that you missed.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: 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.
Slovenian: Fluvastatin učinkuje predvsem v jetrih in je v glavnem racemat dveh eritroenantiomer, od katerih je ena farmakološko aktivna.
English: • in patients with known hypersensitivity to fluvastatin or any of the excipients.
Slovenian: • pri bolnikih z znano preobčutljivostjo za fluvastatin ali katerokoli pomožno snov;
English: 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.
Slovenian: 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.
English: The CHMP also agreed with the MAH's proposal not to include a recommendation to assess causes of secondary hypercholesterolaemia in the indications section.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: National Road No. 1 (12th Km)
Slovenian: National Road No. 1 (12th Km), Metamorphosis
English: The undesirable effects currently listed are consistently represented in the SPCs of the EU Member States, except for anaphylactic reaction, which was recently included.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The plasma clearance (CL/f) for fluvastatin in man is calculated to be 1.8 ± 0.8 l/min.
Slovenian: Izračunan plazemski očistek (CL/f) za fluvastatin pri človeku znaša 1,8 ± 0,8 l/min.
English: 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.
Slovenian: Zaviranje biosinteze holesterola zmanjšuje holesterol v jetrnih celicah, kar spodbuja sintezo receptorjev LDL in s tem povečuje privzem delcev LDL.
English: Other skin reactions (e.g. eczema, dermatitis, bullous exanthema), face oedema, angioedema Musculoskeletal and connective tissue disorders Rare:
Slovenian: druge kožne reakcije (na primer ekcem, dermatitis, bulozni eksantem), edem obraza, angioedem Bolezni mišično-skeletnega sistema in vezivnega tkiva redki:
English: 2100 Kopenhagen Ø, Denmark
Slovenian: 2100 Kopenhagen Ø Danska
English: Itraconazole and erythromycin
Slovenian: Itrakonazol in eritromicin
English: 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]
Slovenian: 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]
English: Children and adolescents with heterozygous familial hypercholesterolaemia No pharmacokinetic data in children are available.
Slovenian: Otroci in mladostniki s heterozigotno familiarno hiperholesterolemijo Ni podatkov o farmakokinetičnih lastnostih pri otrocih.
English: Based on the recommendation given by the CHMP, the following wording proposed was agreed: ‘Renal Impairment
Slovenian: Na podlagi priporočil CHMP je bilo sprejeto naslednje predlagano besedilo: „Okvarjeno delovanje ledvic
English: The major components circulating in the blood are fluvastatin and the pharmacologically inactive N-desisopropyl-propionic acid metabolite.
Slovenian: Poglavitni spojini, ki krožita po krvi, sta fluvastatin in farmakološko neaktivni presnovek N-desizopropil-propionska kislina.
English: Following the procedure the MAH submitted the approved paediatric wording to all EU member states.
Slovenian: Imetnik dovoljenja za promet z zdravilom je po tem postopku predložil odobreno besedilo za pediatrično rabo vsem državam članicam EU.
English: Dose adjustments should be made at intervals of 4 weeks or more.'
Slovenian: Odmerek je zato treba prilagajati v presledkih po 4 tedne ali več.“
English: - For children (aged 9 years and older) the usual starting dose is 20 mg per day.
Slovenian: - Običajni začetni odmerek za otroke (stare 9 let ali starejše) je 20 mg na dan.