FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Slovenian: Prirejeno po ״Prevention of coronary heart disease in clinical practice: Recomendations of the Second Joint Task Force of European and Other Societes on Coronary Prevention״ ; Atherosclerosis 140 (1998)
English: Therefore, special caution should be exercised when atorvastatin is used in combination with such medicinal agents (see section 4.4).
Slovenian: Zato je med sočasno uporabo atorvastatina v kombinaciji s takšnimi zdravili potrebna posebna previdnost (glejte tudi poglavje 4.4).
English: Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Slovenian: Sočasna uporaba {(Lastniško) ime} in varfarina je v prvih dneh uporabe povzročila majhno skrajšanje protrombinskega časa; protrombinski čas se je normaliziral v 15 dneh uporabe {(Lastniško) ime}.
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate]
Slovenian: <[Glejte Dodatek I - Izpolni država članica]> [For referral procedures]
English: − If you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin' or ‘-fibrate' medicines)
Slovenian: − če ste v preteklosti imeli težave z mišicami pri zdravljenju z drugimi zdravili za zniževanje ravni maščob v krvi (npr. zdravili iz skupine 'statinov' ali 'fibratov')
English: In the light of the above the CHMP concludes that the indication for atorvastatin “Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors.” adequately reflects the available data.
Slovenian: Glede na zgoraj zapisano CHMP zaključuje, da indikacija „Preprečevanje srčno-žilnih dogodkov pri bolnikih, ki imajo veliko ocenjeno tveganje za prvi srčno-žilni dogodek, kot dopolnilo h korekciji drugih dejavnikov tveganja.“ zadostno odraža dostopne podatke.
English: Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Slovenian: Sočasna uporaba večkratnih odmerkov {(Lastniško) ime} in fenazona je na očistek fenazona vplivala malo ali nič.
English: − if you have a muscle disorder called myopathy (repeated or unexplained muscle aches or pains)
Slovenian: − če imate bolezen skeletnih mišic, imenovano miopatija (ponavljajoče se bolečine in krči v mišicah nepojasnjenega izvora)
English: If you experience side effects, please inform your doctor.
Slovenian: Če izkusite neželene učinke, o tem obvestite svojega zdravnika.
English: Whether to exclude the target population of the ASCOT-LLA study from the proposed indication, thus precluding the treatment of non-diabetic patients at high cardiovascular risk.
Slovenian: Ali naj se iz predlagane indikacije izključi ciljna populacija preskušanja ASCOT-LLA in s tem onemogoči zdravljenje bolnikov brez sladkorne bolezni, ki imajo veliko tveganje za srčno-žilno bolezen?
English: However, the medicinal product does not appear to undergo significant enterohepatic recirculation.
Slovenian: Kot kaže, zdravilo nima pomembne enterohepatične recirkulacije.
English: - It is proposed to add the following indication in section 4.1: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Slovenian: - Predlaga se dodatek naslednje indikacije v poglavje 4.1: Preprečevanje srčno-žilnih dogodkov pri bolnikih, ki imajo veliko ocenjeno tveganje za prvi srčno-žilni dogodek (glejte poglavje 5.1), kot dopolnilo h korekciji drugih dejavnikov tveganja.
English: Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Slovenian: Klinično pomembno zvišanje (> 3-kratna ZNM) serumskih transaminaz se je pojavilo pri 0,8% bolnikov, ki so jemali {(Lastniško) ime}.
English: Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Slovenian: Zvišanje kreatin fosfokinaze (CPK), ki je presegalo 3-kratno ZNM, se je pojavilo pri 2,5% bolnikov, ki so jemali {(Lastniško) ime}, kar je podobno kot v kliničnih raziskavah z drugimi zaviralci HMG CoA reduktaze.
English: The main concern relates to the “risk of CVD”.
Slovenian: Glavni zadržek se nanaša na „tveganje za srčno-žilne bolezni“.
English: Whether the cardioprotective effect of atorvastatin is higher when used in combination with particular antihipertensive therapy(ies) and whether this should be reflected in the SPC.
Slovenian: Ali je kardioprotektivni učinek atorvastatina večji, če se uporablja v kombinaciji s specifičnim(i) antihipertenzivnim(i) zdravljenjem(nji) in ali naj to odraža Povzetek glavnih značilnosti zdravila?
English: Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Slovenian: Celotna umrljivost in kardiovaskularna umrljivost sta bili številčno večji pri ženskah (38 v primerjavi s 30 in 17 v primerjavi z 12), vendar to ni bilo statistično pomembno.
English: The effect of inducers of cytochrome P450 3A4 (e.g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Slovenian: Vpliv induktorjev citokroma P450 3A4 (npr. rifampicina ali fenitoina) na {(Lastniško) ime} ni znan.
English: − Geriatric: Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations.
Slovenian: Posebne populacije - Starejši: Koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi je pri zdravih starejših osebah večja kot pri mladih odraslih, učinki na lipide pa so primerljivi tistim pri mlajših bolnikih.
English: In a 2-year study in mice, incidences of hepatocellular adenoma in males and hepatocellular carcinomas in females were increased at the maximum dose used, and the maximum dose used was 250-fold higher than the highest human dose on a mg/kg body-weight basis.
Slovenian: Med dveletno raziskavo na miših je ob največjem uporabljenem odmerku pri samcih porasla incidenca hepatocelularnega adenoma, pri samicah pa hepatocelularnega karcinoma; največji uporabljeni odmerek (v mg/kg telesne mase) je bil 250-krat večji od največjega odmerka pri človeku.
English: These include:
Slovenian: Ti učinki so:
English: Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Slovenian: Odmerjanje je treba določiti posamezno glede na izhodiščno koncentracijo holesterola LDL, cilj zdravljenja in bolnikov odziv.
English: Do not take {PRODUCT NAME} if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.
Slovenian: Če ste noseči, če mislite, da bi lahko bili noseči, ali če skušate zanositi, ne smete jemati zdravila {(Lastniško) ime}.
English: The absolute and relative risk reduction effect of atorvastatin was as follows:
Slovenian: Absolutni in relativni učinek zmanjšanja tveganja z atorvastatinom je bil naslednji:
English: Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Slovenian: Jetra trigliceride in holesterol vgradijo v lipoproteine zelo majhne gostote (VLDL) in jih sprostijo v plazmo, s katero pridejo v periferna tkiva.
English: The CARDS study was conducted in 2,838 patients (40-75 years of age) with normal to mildly elevated cholesterol levels, with type 2 diabetes and 1 additional CV risk factor, and without clinically evident CHD.
Slovenian: Raziskava CARDS je bila opravljena na 2838 bolnikih (starih od 40 do 75 let) z normalnimi ali rahlo zvišanimi ravnmi holesterola, sladkorno boleznijo tipa 2 in 1 dodatnim srčno-žilnim dejavnikom tveganja in brez klinično izražene koronarne srčne bolezni.
English: Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Slovenian: Tveganje za rabdomiolizo se zveča, če je atorvastatin uporabljen sočasno z določenimi zdravili, kakršna so npr.: ciklosporin, eritromicin, klaritromicin, itrakonazol, ketokonazol, nefazodon, niacin, gemfibrozil, drugi fibrati ali zaviralci HIV-proteaze (glejte poglavji 4.5 in 4.8).
English: Atorvastatin significantly reduced the frequency of coronary and CV events, strokes and revascularisation procedures in the entire study cohort, but a beneficial effect in the female subgroup could not be established, and overall mortality and CV mortality were numerically higher (not significant) in female patients.
Slovenian: Atorvastatin je statistično značilno znižal pogostnost koronarnih in srčno-žilnih dogodkov, infarktov in revaskularizacijskih posegov v celotni preiskani kohorti, vendar koristnega učinka pri ženskah niso mogli dokazati, razen tega je bila skupna smrtnost ter smrtnost zaradi srčnožilnih bolezni pri bolnicah številčno višja (statistično neznačilno).
English: Do not use any tools or machines if your ability to use them is affected by this medicine.
Slovenian: Ne upravljajte z orodji ali s stroji, če to zdravilo vpliva na vaše sposobnosti za upravljanje le-teh.
English: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Slovenian: Preprečevanje kardiovaskularnih dogodkov pri bolnikih, za katere so ocenili, da pri njih obstaja visoko tveganje za prvi kardiovaskularni dogodek (glejte poglavje 5.1), kot dodatek k obvladovanju ostalih dejavnikov tveganja.
English: Women of child-bearing age must take appropriate contraceptive measures.
Slovenian: Ženske v rodni dobi morajo uporabljati primerno kontracepcijsko zaščito.
English: In the primary prevention trials the dose was 10 mg/day.
Slovenian: V preskušanjih primarnega preprečevanja je bil odmerek 10 mg/dan.
English: All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Slovenian: Vsi bolniki so imeli najmanj enega od naslednjih dejavnikov tveganja: hipertenzija, trenutno kadilstvo, retinopatija, mikroalbuminurija ali makroalbuminurija.
English: The trial results show that for some low risk subgroups included in the studies, corresponding to large populations, treatment is probably not justified with current knowledge, and approving such an indication would result in the treatment of many patients that have no benefit from lipid lowering therapy.
Slovenian: Rezultati preskušanja kažejo, da za nekatere podskupine z majhnim tveganjem, ki ustrezajo velikim populacijam, zdravljenje na osnovi trenutnega znanja verjetno ni upravičeno.
English: Other possible side effects with {PRODUCT NAME}:
Slovenian: Ostali možni neželeni učinki pri jemanju {(Lastniško) ime}:
English: Treatment with atorvastatin 80 mg/day increased the time to occurrence of the combined primary endpoint, defined as death from any cause, nonfatal MI, resuscitated cardiac arrest, or angina pectoris with evidence of myocardial ischaemia requiring hospitalization, indicating a risk reduction by 16% (p=0.048).
Slovenian: Zdravljenje z atorvastatinom 80 mg dnevno je podaljšalo čas do nastopa sestavljenega primarnega opazovanega dogodka, ki je bil definiran kot smrt zaradi kateregakoli razloga, miokardni infarkt brez smrtnega izida, uspešno oživljanje po zastoju srca ali angina pektoris z znaki ishemije miokarda, zaradi katere je potrebna hospitalizacija, kar kaže na 16odstotno zmanjšanje tveganja (p=0,048).
English: If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Slovenian: Če je vrednost CPK izhodiščno zelo velika (> 5-kratna ZNM), je treba CPK za potrditev izvida ponovno izmeriti čez 5 do 7 dni.
English: For oral use only.
Slovenian: Za peroralno uporabo.
English: Rare: myositis, rhabdomyolysis.
Slovenian: Redko: miozitis, rabdomioliza.
English: − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Slovenian: - Če se takšni simptomi pojavijo med zdravljenjem z atorvastatinom, je treba določiti CPK.
English: A standard cholesterol lowering diet should be continued during treatment.
Slovenian: Med zdravljenjem je treba nadaljevati s standardno prehrano za zmanjševanje ravni holesterola.
English: − Renal insufficiency: Renal disease has no influence on the plasma concentrations or lipid effects of atorvastatin and its active metabolites.
Slovenian: - Ledvična insuficienca: Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina in njegovih aktivnih presnovkov v plazmi niti na njihov učinek na lipide.
English: Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
Slovenian: V kliničnih raziskavah so zaradi neželenih učinkov, ki so jih pripisali {(Lastniško) ime}, zdravljenje prekinili pri manj kot 2% bolnikov.
English: − If muscular symptoms are severe and cause daily discomfort, even if the CPK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered.
Slovenian: - Če so mišični simptomi hudi in povzročajo težave v vsakodnevnem življenju, je treba razmisliti o prekinitvi zdravljenja tudi, če je vrednost CPK ≤ 5-kratna ZNM.
English: − Angioneurotic oedema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing), Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and genitals), erythema multiforme (patchy red rash).
Slovenian: − Angionevrotični edem (oteklina obraza, jezika in sapnika, ki lahko povzroči velike težave pri dihanju), Stevens-Johnsonov sindrom (hujši mehurjasti izpuščaji po koži, ustih, očeh in genitalijah), multiformni eritem (makulopapulozen rdeč izpuščaj).
English: Nonetheless, the CHMP thought it relevant to reflect this finding and include following factual statement in the pragraph summarising the results of ASCOT-LLA under section 5.1 of the SPC.
Slovenian: Kljub temu je CHMP mnenja, da je pomembno prikazati ta rezultat in ga vključiti za navedbami dejstev v odstavku, ki povzema rezultate raziskave ASCOT-LLA v poglavju 5.1 Povzetka glavnih značilnosti zdravila.
English: If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your {PRODUCT NAME} treatment to predict your risk of muscle related side effects.
Slovenian: Če karkoli od zgoraj naštetega velja za vas, bo vaš zdravnik za oceno tveganja za pojav neželenih učinkov, povezanih z mišicami, izvedel preiskave krvi pred zdravljenjem s {(Lastniško) ime} in verjetno tudi med njim.
English: − Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, ketoconazole,
Slovenian: − nekateri antibiotiki ali zdravila proti glivicam, npr. eritromicin, klaritromicin, ketokonazol, itrakonazol; rifampicin
English: There was no evidence of a difference in the treatment effect by patient's gender, age, or baseline LDL-C level.
Slovenian: Opažene niso bile nobene razlike v učinku zdravljenja glede na spol, starost ali izhodiščno raven LDL-holesterola.
English: Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Slovenian: Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina v plazmi niti na njegove učinke na lipide, zato odmerka ni treba prilagajati.
English: Read all of this leaflet carefully before you start taking this medicine.
Slovenian: Pred uporabo natančno preberite to navodilo!
English: In the initial type II variation dossier submitted by MRP, the Applicant claimed the following indication: “Prevention of cardiovascular events in patients with multiple risk factors (e.g. type 2 diabetics with one risk factor and hypertensive patients with 3 risk factors) with normal or elevated cholesterol levels but without clinically evident coronary heart disease (CHD)”.
Slovenian: V prvotni dokumentaciji za variacijo tipa II, ki je bila predložena v postopkih medsebojnega priznavanja, je vlagatelj navedel naslednjo indikacijo: „Preprečevanje srčno-žilnih dogodkov pri bolnikih z več dejavniki tveganja (npr. bolnikih s sladkorno boleznijo tipa 2 in enim dejavnikom tveganja in bolnikih s hipertenzijo in 3 dejavniki tveganja) in normalnimi ali zvišanimi ravnmi holesterola brez klinično izražene koronarne srčne bolezni (CHD)“.
English: The maximum dose used was 63-fold higher than the highest human dose (80 mg/day) on a mg/kg body-weight basis and 8- to 16-fold higher based on AUC(0-24) values as determined by total inhibitory activity.
Slovenian: Največji uporabljeni odmerek je bil glede na mg/kg telesne mase 63-krat večji od največjega odmerka pri človeku (80 mg/kg), glede na vrednosti AUC(0-24) ugotovljene s celotnim zaviralnim delovanjem, pa 8 do 16-krat večji.
English: − This medicine has been prescribed for you.
Slovenian: − To zdravilo je bilo predpisano za vas osebno in ga ne smete dajati drugim.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Slovenian: Zdravilo je v članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija
English: Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipidlowering medication.
Slovenian: Atorvastatin učinkovito zniža holesterol LDL pri bolnikih s homozigotno familiarno hiperholesterolemijo, se pravi v populaciji, ki se ponavadi ne odzove na zdravljenje s hipolipemičnimi zdravili.
English: Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
Slovenian: Občasno: alopecija, hiperglikemija, hipoglikemija, pankreatitis.
English: As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
Slovenian: Tako kot pri drugih zaviralcih HMG CoA reduktaze tudi pri bolnikih, zdravljenih s {(Lastniško) ime}, poročajo o zvišanju serumskih transaminaz.
English: Use as directed by your doctor.
Slovenian: Upoštevajte zdravnikova navodila.
English: Uncommon: anorexia, vomiting.
Slovenian: Občasno: anoreksija, bruhanje.
English: In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
Slovenian: V analizah podskupin, razdeljenih po spolu (81 % moških, 19 % žensk), se je pokazal koristen učinek atorvastatina pri moških, ki pa ga niso mogli dokazati za ženske - morda zaradi nizke stopnje dogodkov pri ženskah.
English: Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Slovenian: Sočasno uporabo atorvastatina in zaviralcev proteaz, ki so znani zaviralci citokroma P450 3A4, je spremljalo zvišanje koncentracije atorvastatina v plazmi.
English: Interaction may occur when {PRODUCT NAME} is administered with inhibitors of cytochrome P450 3A4 (e.g. ciclosporin, macrolide antibiotics including erythromycin and clarithromycin, nefazodone, azole antifungals including itraconazole and HIV protease inhibitors).
Slovenian: Medsebojno delovanje se lahko pojavi, če {(Lastniško) ime} uporabljamo sočasno z zaviralci citokroma P450 3A4 (npr. ciklosporinom, makrolidnimi antibiotiki, vključno z eritromicinom in klaritromicinom, nefazodonom, azolnimi antimikotiki vključno z itrakonazolom in zaviralci HIV proteaze).
English: Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.
Slovenian: Približno 70% zaviralnega delovanja na HMG CoA reduktazo v obtoku pripisujejo aktivnim presnovkom.
English: • The MAH has implemented the text proposed by the CHMP in the SPC:
Slovenian: • je imetnik dovoljenja za promet z zdravilom v Povzetku glavnih značilnosti zdravila vključil naslednje besedilo, ki ga predlaga CHMP:
English: {PRODUCT NAME} is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed.
Slovenian: {(Lastniško) ime} se uporablja za znižanje zvišanega holesterola in trigliceridov, kadar prehrana z malo maščob in spremembe življenjskega stila niso dovolj učinkovite.
English: This interaction may be explained by an inhibition of the membrane transport protein, P-glycoprotein.
Slovenian: To medsebojno delovanje je mogoče pojasniti z zavrtjem membranske transportne beljakovine, glikoproteina P. Bolnike, ki jemljejo digoksin, je treba ustrezno nadzorovati.
English: − Keep this leaflet.
Slovenian: − Shranite navodilo.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: RAZLOGI ZA DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDL-C and apolipoprotein A1 in a dose response study.
Slovenian: V raziskavi odzivanja na odmerjanje je atorvastatin zmanjšal koncentracijo celotnega holesterola (za 30-46%), holesterola LDL (za 41-61%), apolipoproteina B (za 34-50%) in trigliceridov (za 14-33%) obenem pa različno močno zvišal holesterol HDL in apolipoprotein A1.
English: − Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol
Slovenian: − druga zdravila za zniževanje ravni maščob v krvi, npr. gemfibrozil, drugi fibrati, derivati nikotinske kisline, holestipol
English: {PRODUCT NAME} belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Slovenian: {(Lastniško) ime} spada v skupino zdravil, imenovano statini, ki so zdravila za uravnavanje ravni maščob v krvi.
English: How to adequately reflect in the SPC the lack of a significant effect in favour of atorvastatin for the composite primary endpoint and several secondary endpoints in the female subgroup.
Slovenian: Kako naj besedilo Povzetka glavnih značilnosti zdravila ustrezno odraža odsotnost statistično značilnega učinka atorvastatina v sestavljenem primarnem kazalcu izida in več sekundarnih kazalcih izida pri ženskah?
English: The median percent change, from baseline, in total atheroma volume (the primary study criteria) was0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
Slovenian: Mediani odstotek spremembe celotnega volumna ateroma (ki je bil v študiji primarno merilo) od izhodišča je bil v skupini z atorvastatinom - 0,4% (p=0,98) in v skupini s pravastatinom + 2,7% (p=0,001) (n=249).
English: Strokes (Fatal and non-fatal)
Slovenian: Infarkti (s smrtnim izidom in brez)
English: At the end of the MRP procedure there was a discrepancy between Member States regarding the wording of the proposed indication that adequately reflects the data of the ASCOT-LLA and CARDS studies, effectively excluding treatment in non-diabetics, and an official referral for arbitration was notified by Spain to the CHMP on 1 December 2005.
Slovenian: Na koncu postopka medsebojnega priznavanja je prišlo do razlik med državami članicami v zvezi z besedilom predlagane indikacije, ki bi ustrezno odražalo podatke iz raziskav ASCOT-LLA in CARDS, pri čemer bi učinkovito izključili zdravljenje bolnikov brez sladkorne bolezni.