natgillin/translations-raw huggingface dataset:
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required. 
Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina v plazmi niti na njegove učinke na lipide, zato odmerka ni treba prilagajati.
Read all of this leaflet carefully before you start taking this medicine. 
Pred uporabo natančno preberite to navodilo!
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)”. 
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)“.
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. 
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.
− This medicine has been prescribed for you. 
− To zdravilo je bilo predpisano za vas osebno in ga ne smete dajati drugim.
This medicinal product is authorised in the Member States of the EEA under the following names: 
Zdravilo je v članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: Avstrija
Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipidlowering medication. 
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.
Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis. 
Občasno: alopecija, hiperglikemija, hipoglikemija, pankreatitis.
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}. 
Tako kot pri drugih zaviralcih HMG CoA reduktaze tudi pri bolnikih, zdravljenih s {(Lastniško) ime}, poročajo o zvišanju serumskih transaminaz.
Use as directed by your doctor. 
Upoštevajte zdravnikova navodila.
Uncommon: anorexia, vomiting. 
Občasno: anoreksija, bruhanje.
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. 
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.
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin. 
Sočasno uporabo atorvastatina in zaviralcev proteaz, ki so znani zaviralci citokroma P450 3A4, je spremljalo zvišanje koncentracije atorvastatina v plazmi.
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). 
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).
Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. 
Približno 70% zaviralnega delovanja na HMG CoA reduktazo v obtoku pripisujejo aktivnim presnovkom.
• The MAH has implemented the text proposed by the CHMP in the SPC: 
• je imetnik dovoljenja za promet z zdravilom v Povzetku glavnih značilnosti zdravila vključil naslednje besedilo, ki ga predlaga CHMP:
{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. 
{(Lastniško) ime} se uporablja za znižanje zvišanega holesterola in trigliceridov, kadar prehrana z malo maščob in spremembe življenjskega stila niso dovolj učinkovite.
This interaction may be explained by an inhibition of the membrane transport protein, P-glycoprotein. 
To medsebojno delovanje je mogoče pojasniti z zavrtjem membranske transportne beljakovine, glikoproteina P. Bolnike, ki jemljejo digoksin, je treba ustrezno nadzorovati.
− Keep this leaflet. 
− Shranite navodilo.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS 
RAZLOGI ZA DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
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. 
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.
− Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol 
− druga zdravila za zniževanje ravni maščob v krvi, npr. gemfibrozil, drugi fibrati, derivati nikotinske kisline, holestipol
{PRODUCT NAME} belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. 
{(Lastniško) ime} spada v skupino zdravil, imenovano statini, ki so zdravila za uravnavanje ravni maščob v krvi.
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. 
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?
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). 
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).
Strokes (Fatal and non-fatal) 
Infarkti (s smrtnim izidom in brez)
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. 
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.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. 
Specifičnega zdravljenja za preveliko odmerjanje {(Lastniško) ime} ni.V primeru prevelikega odmerjanja, je treba bolnika zdraviti siptomatsko in uvesti podporne ukrepe, kot je potrebno.
An interaction study with cimetidine and {PRODUCT NAME} was conducted, and no interaction was seen. 
Raziskava interakcij cimetidina in {(Lastniško) ime} ni pokazala nobenega medsebojnega delovanja.
Batch/ EXP: see individual pack (label for sticker for hospital packs only) 
Serija / uporabno do: glej posamezno pakiranje (označba le za nalepko za bolnišnično pakiranje)
Coadministration of {PRODUCT NAME} with an oral antacid suspension containing magnesium and aluminium hydroxides decreased plasma concentrations of atorvastatin and its active metabolites approx. 35%; however, LDL-C reduction was not altered. 
Sočasna uporaba {(Lastniško) ime} s peroralno antacidno suspenzijo, ki je vsebovala magnezijev in aluminijev hidroksid, je zmanjšala plazemsko koncentracijo atorvastatina in njegovih aktivnih presnovkov v plazmi za približno 35%, vendar na znižanje holesterola LDL ni vplivala.
Atorvastatin also significantly reduced mean TC by 34.1% (pravastatin: -18.4%, p<0.0001), mean TG levels by 20% (pravastatin: -6.8%, p<0.0009), and mean apolipoprotein B by 39.1% (pravastatin: -22.0%, p<0.0001). 
Atorvastatin je tudi pomembno znižal povprečni celotni holesterol za 34,1% (pravastatin: -18,4%, p<0,0001), povprečno koncentracijo trigliceridov za 20% (pravastatin: -6,8%, p<0,0009) in povprečni apolipoprotein B za 39,1% (pravastatin: -22,0%, p<0,0001).
The usual starting dose is 10 mg once a day. 
Običajen začetni odmerek je 10 mg {(Lastniško) ime} enkrat na dan.
Rare: hepatitis, cholestatic jaundice. 
Redko: hepatitis, holestatski ikterus.
In this randomized, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients. 
Preiskavo z IVUZ so v tej randomiziranem, dvojno slepem, multicentričnem kontroliranem kliničnem preskušanju opravili pri 502 bolnikih, in sicer na začetku in po 18 mesecih.
For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/l (or < 115 mg/dl) and total cholesterol < 5 mmol/l (or < 190 mg/dl). 
Pri bolnikih z ugotovljeno koronarno boleznijo srca in drugih bolnikih, ki jih ogrožajo ishemični zapleti, sta cilj zdravljenja holesterol LDL < 3 mmol/l (< 1,15 mg/ml) in celotni holesterol < 5 mmol/l (< 1,90 mg/ml).
Total mortality and cardiovascular mortality were not significantly reduced (185 vs. 212 events, p=0.17 and 74 vs. 82 events, p=0.51). 
Celotna umrljivost in kardiovaskularna umrljivost se nista pomembno zmanjšali (185 dogodkov v primerjavi z 212, p=0,17, in 74 dogodkov v primerjavi z 82, p=0,51).
The most commonly expected adverse events are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain and usually ameliorate on continued treatment. 
Najpogosteje pričakovani neželeni učinki so predvsem prebavni, med drugim zaprtje, napenjanje, dispepsija in bolečine v trebuhu.
However, lipid effects were greater when {PRODUCT NAME} and colestipol were coadministered than when either medicinal product was given alone. 
Vendar pa je bil učinek na lipide večji, če sta bila {(Lastniško) ime} in holestipol uporabljena skupaj, kot če je bilo vsako zdravilo uporabljeno posebej.
In the Reversing Atherosclerosis with Aggressive Lipid- Lowering Study (REVERSAL), the effect of intensive lipid lowering with atorvastatin 80 mg and standard degree of lipid lowering with pravastatin 40 mg on coronary atherosclerosis was assessed by intravascular ultrasound (IVUS), during angiography, in patients with coronary heart disease. 
V študiji REVERSAL (Reversing Atherosclerosis with Aggressive lipid-Lowering Study) so pri bolnikih s koronarno srčno boleznijo uporabili preiskavo z intravaskularnim ultrazvokom (IVUZ) in z njo med angiografijo ocenili učinek intenzivnega nižanja lipidov z 80 mg atorvastatina in standardnega nižanja lipidov s 40 mg pravastatina na koronarno aterosklerozo.
A relative risk reduction in death of 27% (82 deaths in the placebo group compared to 61 deaths in the atorvastatin group) was observed with a borderline statistical significance (p=0.0592). 
Relativno zmanjšanje tveganja za smrt je bilo 27-odstotno (82 smrtnih primerov v skupini, ki je prejemala placebo, v primerjavi z 61 smrtnimi primeri v skupini, ki je prejemala atorvastatin) z mejno sprejemljivo statistično značilnostjo (p=0,0592).
The blisters consist of a forming film made of polyamide/aluminum foil/polyvinyl chloride and a backing made of either paper/polyester/aluminum foil/vinyl heat-seal coating or aluminum foil/vinyl heat-seal coating. 
Folijsko-folijski pretisni omoti z enoodmernimi pretisnimi razdelki iz poliamida/aluminijske folije/polivinilklorida in podloga iz papirja/poliestra/aluminijske folije/vinila za toplotno lepljenje oz. podlago iz aluminijske folije/vinila za toplotno lepljenje.
Absolute Risk 
Absolutno zmanjšanje tveganja
OTHER {for blisters of 7 tablets - the abbreviated days of the week may be printed on the foil for each tablet i.e. MON, TUE, WED, THU, FRI, SAT, SUN 
Na pritisnem omotu s 7 tabletami so lahko na foliji za vsako tableto natisnjeni skrajšano zapisani dnevi v tednu (pon, tor, sre, čet, pet, sob, ned).
A favourable trend was observed regarding the mortality rate (82 deaths in the placebo group vs. 61 deaths in the atorvastatin group, p=0.0592). 
Opažen je bil ugoden trend glede na stopnjo smrtnosti (82 smrti v skupini s placebom, 61 smrti v skupini z zdravljenjem, p=0,0592).
No. of Events (Atorvastatin vs Placebo) 
št. dogodkov (atorvastatin v primerjavi s placebom)
− Gender: Concentrations of atorvastatin and its active metabolites in women differ from those in men (Women: approx. 20% higher for Cmax and approx. 10 % lower for AUC). 
- Otroci: Farmakokinetičnih podatkov za otroke ni. - Spol: Koncentracija atorvastatina in njegovih aktivnih presnovkov je pri ženskah drugačna kot pri moških (Cmax je pri ženskah približno 20% večja, AUC pa 10% manjša) kot pri moških.
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomised, double-blind, multicentre, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤4.14 mmol/l (160 mg/dl) and TG≤6.78 mmol/l (600 mg/dl). 
Učinek atorvastatina na kardiovaskularne bolezni s smrtnim izidom in brez njega so ocenili tudi v randomiziranem, dvojno slepem, multicentričnem, s placebom kontroliranem preskušanju CARDS (Collaborative Atorvastatin Diabetes Study), ki je vključevalo bolnike z diabetesom tipa 2, stare od 40 do 75 let, brez anamneze predhodne kardiovaskularne bolezni ter s koncentracijo holesterola LDL 4,14 mmol/l (160 mg/dl) in trigliceridov ≤ 6,78 mmol/l (600 mg/dl).
There was a 36.4% mean reduction in CRP in the atorvastatin group compared to a 5.2% reduction in the pravastatin group (p<0.0001). 
V skupini z atorvastatinom se je CRP v povprečju znižal za 36,4%, vskupini s pravastatinom pa za 5,2% (p<0,0001).
Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5168) or placebo (n=5137). 
Bolniki so bili zdravljeni z antihipertenzivnim zdravljenjem (bodisi z amlodipinom ali z režimom na osnovi atenolola) in bodisi z atorvastatinom 10 mg dnevno (n=5168) ali placebom (n=5137).
− Hepatic insufficiency: Plasma concentrations of atorvastatin and its active metabolites are markedly increased (approx. 16-fold in Cmax and approx. 11-fold in AUC) in patients with chronic alcoholic liver disease (Childs-Pugh B). 
- Jetrna insuficienca: Pri bolnikih s kronično alkoholno boleznijo jeter (Child-Pugh B) je koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi občutno zvečana (Cmax je približno 16-krat, AUC pa 11-krat večja).
Higher dosages may be necessary in order to attain (LDL-)cholesterol levels according to current guidelines. 
Za doseganje ravni holesterola LDL, kakršne priporočajo trenutne smernice, bodo morda potrebni višji odmerki.
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure. 
Tako kot drugi zaviralci HMG-CoA reduktaze, lahko tudi atorvastatin v redkih primerih prizadene skeletne mišice in povzroči mialgijo, miozitis in miopatijo, ki lahko napreduje v rabdomiolizo - ta je lahko smrtno nevarna, značilni zanjo pa so izrazito zvišanje vrednosti CPK (> 10-kratna ZNM)mioglobinemija in mioglobinurija, ki lahko povzroči odpoved ledvic.
Coadministration of atorvastatin 10 mg OD and erythromycin (500 mg QID), or atorvastatin 10 mg OD and clarithromycin (500 mg BID), known inhibitors of cytochrome P450 3A4, were associated with higher plasma concentrations of atorvastatin. 
Sočasno uporabo 10 mg atorvastatina enkrat na dan in eritromicina (500 mg štirikrat na dan) oz. klaritromicina (500 mg dvakrat na dan) - oba sta znana zaviralca citokroma P450 3A4 - je spremljalo zvečanje koncentracije atorvastatina v plazmi.
Atorvastatin significantly reduced the frequency of major CV events, the frequency of fatal, non-fatal AMI and silent MI and the frequency of strokes. 
Atorvastatin je statistično značilno znižal pogostnost poglavitnih srčno-žilnih dogodkov, pogostnost akutnega miokardnega infarkta (AMI) s smrtnim izidom ali brez, tihih miokardnih infarktov ter pogostnost kapi.
Higher dosages may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines. 
Za doseganje ravni (LDL-)holesterola, ki so v skladu s trenutnimi smernicami, so morda potrebni večji odmerki.
Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA, revascularization, stroke) MI (fatal and non-fatal AMI, silent MI) 
Poglavitni srčno-žilni dogodki (AMI s smrtnim izidom ali brez, tihi MI, smrt zaradi akutne CHD, nestabilna angina, CABG, PTCA, revaskularizacija, infarkt) MI (AMI s smrtnim izidom ali brez, tihi MI)
Concomitant administration can lead to increased plasma concentrations of atorvastatin. 
Med sočasno uporabo lahko koncentracija atorvastatina v plazmi poraste.
As with all medicines, {PRODUCT NAME} can sometimes cause side effects in some individuals. 
Kot vsa zdravila lahko {(Lastniško) ime} povzroči neželene učinke pri nekaterih posameznikih.
In the atorvastatin group, LDL-C was reduced to a mean of 2.04 mmol/l ± 0.8 (78.9 mg/dl ± 30) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 28) and in the pravastatin group, LDL-C was reduced to a mean of 2.85 mmol/l ± 0.7 (110 mg/dl ± 26) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 26) (p<0.0001). 
V skupini z atorvastatinom se je holesterol LDL z izhodiščnih 3,89 mmol/l ± 0,7 (150 mg/dL ± 28) znižal na povprečno 2,04 mmol/L ± 0,8 (78,9 mg/dL ± 30), v skupini s pravastatinom pa z izhodiščnih 3,89 mmol/l ± 0,7 (150 mg/dL ± 26) na povprečno 2,85 mmol/L ± 0,7 (110 mg/dL ± 26) (p<0,0001).
The currently approved indications for atorvastatin are: as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and tryglicerides in patients with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. 
Trenutno odobrene indikacije za atorvastatin so: kot dopolnilo k dieti za znižanje zvišanih vrednosti skupnega holesterola, LDL-holesterola, apoliproteina B in trigliceridov pri bolnikih s primarno hiperholesterolemijo, vključno s družinsko hiperholesterolemijo (heterozigotna varianta) ali kombinirano (mešano) hiperlipidemijo (ki ustreza tipoma IIa in IIb v Fredericksonovi klasifikaciji), kadar odziv na dieto in druge nefarmacevtske ukrepe ni zadosten.
Skin/Appendages 
Bolezni kože in podkožja
According to results of in vitro studies the metabolic pathway of atorvastatin via glucuronidation is inhibited by Gemfibrozil. 
Rezultati raziskav in vitro kažejo, da gemfibrozil zavira presnovo atorvastatina z glukuronidacijo.
Do not drive if this medicine affects your ability to drive. 
Vpliv na sposobnost upravljanja vozil in strojev Ne vozite, če to zdravilo vpliva na vašo sposobnost za vožnjo.
The active substance of {PRODUCT NAME} is atorvastatin. 
Zdravilna učinkovina v tabletah {(Lastniško) ime} je atorvastatin.
− if you are hypersensitive (allergic) to {PRODUCT NAME} or to any similar medicines used to lower blood lipids or to any of the other ingredients of the medicine - see Section 5 for details. 
− če ste preobčutljivi za (alergični na) {(Lastniško) ime} ali kakšna podobna zdravila, ki se uporabljajo za zniževanje ravni maščob v krvi, ali na katerokoli sestavino tablet {(Lastniško)
{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. 
{(Lastniško) ime} je indiciran kot dodatek k dieti za znižanje zvišanega celotnega holesterola, holesterola LDL, apolipoproteina B in trigliceridov pri bolnikih s primarno hiperholesterolemijo, vključno s familiarno hiperholesterolemijo (heterozigotna oblika) ali kombinirano (mešano) hiperlipidemijo (kar ustreza tipoma IIa in IIb po Fredricksonovi klasifikaciji), kadar odziv na dieto in druge nefarmakološke ukrepe ni zadosten.
Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol. 
Sočasna uporaba {(Lastniško) ime} in peroralnih kontraceptivov je zvečala koncentracijo noretindrona in etilnilestradiola v plazmi.
The risk of atorvastatin-induced myopathy may be increased with the concomitant use of fibric acid derivatives. 
Sočasna uporaba fibratov lahko zveča tveganje za nastanek z atorvastatinom povezane miopatije.
If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started. 
Če je vrednost CPK izhodiščno zelo velika (> 5-kratna ZNM), zdravljenja ne začnemo.
{PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose and magnesium stearate. 
Tablete {(Lastniško) ime} vsebujejo tudi naslednje pomožne snovi: kalcijev karbonat, mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat, polisorbat 80, hidroksipropilceluloza in magnezijev stearat.
Taking other medicines 
Pot uporabe zdravila
All patients had at least 3 of the pre-defined cardiovascular risk factors: male gender, age ≥55 years, smoking, diabetes, history of CHD in a first-degree relative, TC:HDL-C >6, peripheral vascular disease, left ventricular hypertrophy, prior cerebrovascular event, specific ECG abnormality, proteinuria/albuminuria. 
Vsi bolniki so imeli vsaj 3 od naslednjih, vnaprej določenih dejavnikov kardiovaskularnega tveganja: moški spol, starost ≥ 55 let, kajenje, diabetes, anamnezo koronarne bolezni pri sorodniku v prvem kolenu, razmerje trigliceridi:HDL > 6, periferno žilno bolezen, hipertrofijo levega prekata, predhoden cerebrovaskularni dogodek, specifične nenormalnosti EKG ali proteinurijo/albuminurijo.
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 naveden v tem navodilu, obvestite svojega zdravnika ali farmacevta.