FrancophonIA/ELRC3.0 huggingface dataset:
English: − If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint.
Slovenian: - Če pride do težav z nepričakovanim ali nenavadnim krvavenjem ali podplutbami, lahko to kaže na težave z jetri.
English: If co-administration cannot be avoided, simultaneous coadministration of atorvastatin with rifampin is recommended, with clinical monitoring.
Slovenian: Če se sočasni uporabi ne da izogniti, je pri sočasni uporabi atorvastatina z rifampinom priporočeno klinično spremljanje.
English: Ciclosporin 5.2 mg/kg/day, stable dose
Slovenian: Ciklosporin 5,2 mg/kg/dan, stalni odmerek
English: Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors, ATC code: C10AA05
Slovenian: Farmakoterapevtska skupina: zdravila, ki spreminjajo raven lipidov, zaviralci HMG CoA reduktaze, oznaka ATC: C10AA05
English: [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel)> <{fax}> <{e-mail}>
English: Large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites).
Slovenian: Velike količine grenivkinega soka (več kot 1,2 l v 5 dneh) so povečale AUC atorvastatina 2,5-krat in AUC aktivnosti (atorvastatina in presnovkov).
English: Developmental safety data in this population have not been evaluated.
Slovenian: Podatkov o varnosti za otrokov razvoj ni.
English: Appropriate clinical monitoring of these patients is recommended.
Slovenian: Priporočljivo je ustrezno klinično spremljanje teh bolnikov.
English: Animal studies have shown toxicity to reproduction (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3)
English: Atorvastatin was negative for mutagenic and clastogenic potential in a battery of 4 in vitro tests and 1 in vivo assay.
Slovenian: Atorvastatin ni pokazal mutagenega ali klastogenega potenciala v naboru 4 testov in vitro in 1 preskusu in vivo.
English: Check with your doctor or pharmacist before taking {PRODUCT NAME} − if you have severe respiratory failure.
Slovenian: Preden vzamete zdravilo {(Lastniško) ime} , se posvetujte z zdravnikom ali s farmacevtom - če imate hude težave z dihanjem
English: However, atorvastatin does not appear to undergo significant enterohepatic recirculation.
Slovenian: Kot kaže, atorvastatin nima pomembne enterohepatične recirkulacije.
English: Patients were treated with either atorvastatin 10 mg daily (n=1,428) or placebo (n=1,410) for a median follow-up of 3.9 years.
Slovenian: Bolnike so zdravili bodisi z atorvastatinom 10 mg na dan (n = 1.428), bodisi s placebom (n = 1.410); povprečno spremljanje je trajalo 3,9 leta.
English: Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants.
Slovenian: Ko smo dokumentirali stabilen protrombinski čas, lahko protrombinski čas spremljamo v časovnih presledkih, ki so tudi sicer priporočeni za bolnike, zdravljene s kumarinskimi antikoagulanti.
English: Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Slovenian: Za doseganje ravni holesterola LDL, kakršne priporočajo trenutne smernice, bodo morda potrebni višji odmerki.
English: 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).
Slovenian: 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.
English: Antacid suspension of magnesium and aluminium hydroxides, 30 mL QID, 2 weeks
Slovenian: Antacidna suspenzija magnezijevih in aluminijevih hidroksidov, 30 ml štirikrat na dan, 2 tedna
English: In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk (see section 5.3).
Slovenian: Pri podganah je bila koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi podobna kot v mleku (glejte poglavje 4.3).
English: OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally]
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Izpolni država članica]
English: Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever).
Slovenian: Med značilnostmi, ki se lahko pojavijo, so dispneja, neproduktivni kašelj in poslabšanje splošnega zdravstvenega stanja (utrujenost, zmanjšanje telesne mase in zvišana telesna temperatura).
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: Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve.
Slovenian: Bolnike z zvišanimi vrednostmi transaminaz je treba nadzorovati, dokler nenormalnost(i) ne izgine(jo).
English: * Co-administration of multiple doses of atorvastatin and phenazone showed little or no detectable effect in the clearance of phenazone.
Slovenian: * Sočasna uporaba večkratnih odmerkov atorvastatina in fenazona je na očistek fenazona vplivala malo ali nič.
English: Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality.
Slovenian: Znižanje celotnega holesterola, holesterola LDL in apolipoproteina B dokazano zmanjša tveganje za srčnožilne zaplete in umrljivost zaradi bolezni srca in ožilja.
English: Should an increase in transaminases of greater than 3 times the upper limit of normal (ULN) persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
Slovenian: Če zvišanje transaminaz, ki presega 3-kratno zgornjo normalno mejo (ZNM), traja, je odmerek zdravila {(Lastniško) ime} priporočljivo zmanjšati ali zdravilo ukiniti (glejte poglavje 4.8).
English: Specific treatment is not available for {PRODUCT NAME} overdose.
Slovenian: Specifičnega zdravljenja za prevelik odmerek zdravila {(Lastniško) ime} ni.
English: Dose (mg)
Slovenian: Zdravilo/odmerek (mg)
English: SLOC1B1 polymorphism: Hepatic uptake of all HMG-CoA reductase inhibitors including atorvastatin, involves the OATP1B1 transporter.
Slovenian: Polimorfizem SLOC1B1: Jetrni privzem vseh zaviralcev reduktaze HMG-CoA, vključno z atorvastatinom, vključuje prenašalec OATP1B1.
English: In patients with SLCO1B1 polymorphism there is a risk of increased exposure of atorvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4).
Slovenian: Pri bolnikih s polimorfizmom SLOCIB1 obstaja tveganje za povečano izpostavljenost atorvastatinu, ki lahko vodi do povečanega tveganja za rabdomiolizo (glejte poglavje 4.4).
English: The effect of inhibition of hepatic uptake transporters on atorvastatin concentrations in hepatocytes is unknown.
Slovenian: Učinek zaviranja prenašalca jetrnega privzema na koncentracije atorvastatina v hepatocitih ni znan.
English: The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Taking other medicines”).
Slovenian: Tveganje za neželene učinke, povezane z mišicami (npr. rabdomiolizo), se poveča, če sočasno jemljete nekatera druga zdravila (glejte poglavje 2 "Uporaba drugih zdravil").
English: The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, erythromycin, niacin and ezetimibe.
Slovenian: Tveganje za miopatijo lahko poveča tudi sočasna uporaba gemfibrozila in drugih derivatov fibrinske kisline, eritromicina, niacina in ezetimiba.
English: Liver function tests should be performed and serum CK levels should be monitored.
Slovenian: Narediti je treba laboratorijske preiskave jetrne funkcije in nadzorovati raven CK v serumu.
English: When patients are receiving medicinal products that increase the plasma concentration of atorvastatin, a lower maximum dose of atorvastatin is recommended.
Slovenian: Če bolniki dobivajo zdravila, ki povečujejo koncentracijo atorvastatina v plazmi, je priporočljivo uporabiti manjši največji odmerek atorvastatina.
English: No controlled clinical trials with atorvastatin have been conducted in pregnant women.
Slovenian: Opravljenja ni bila nobena nadzorovana klinična študija nosečnic.
English: The following adverse events have been reported with some statins:
Slovenian: Pri uporabi nekaterih statinov so poročali o naslednjih neželenih učinkih:
English: Although only very rare cases of clinically significant anticoagulant interactions have been reported, prothrombin time should be determined before starting atorvastatin in patients taking coumarin anticoagulants and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs.
Slovenian: Čeprav je bilo v le izjemno redkih primerih opaženo klinično pomembno antikoagulantno medsebojno delovanje, je potrebno pred začetkom uporabe atorvastatina bolnikom, ki jemljejo kumarinske antikoagulante, izmeriti protrombinski čas, nato pa to dovolj pogosto ponoviti še v začetnih fazah zdravljenja, da se prepričamo, da ni prišlo do pomembne spremembe protrombinskega časa.
English: The risk might also be increased at concomitant administration of atorvastatin with other medicinal products that have a potential to induce myopathy, such as fibric acid derivates and ezetimibe (see section 4.4).
Slovenian: Tveganje lahko poveča tudi sočasna uporaba atorvastatina z drugimi zdravili, ki imajo potencial za povzročanje miopatije, denimo derivatov fibrinske kisline in ezetimiba (glejte poglavje 4.4).
English: There was significant treatment interaction by antihypertensive baseline therapy.
Slovenian: Opazili so pomembno interakcijo z zdravljenjem glede na izhodiščno antihipertenzivno terapijo.
English: If possible, alternative (non-interacting) therapies should be considered instead of these medicinal products.
Slovenian: Če je mogoče, je treba namesto o zdravljenju s temi zdravili razmisliti o drugih terapijah, pri katerih ni medsebojnih delovanj.
English: It is not known whether atorvastatin or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se atorvastatin ali njegovi presnovki izločajo pri ljudeh v materino mleko.
English: • Breathing problems including persistent cough and/or shortness of breath or fever
Slovenian: • težave z dihanjem, vključno z nenehnim kašljanjem in/ali zasoplost ali zvišana telesna temperatura.
English: Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Slovenian: Ker se atorvastatin v veliki meri veže na beljakovine v plazmi, ni pričakovati, da bi hemodializa pomembno zvečala njegov očistek.
English: Elevated serum creatine kinase (CK) 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 kinaze (CK), ki je presegalo 3-kratno ZNM, se je pojavilo pri 2,5% bolnikov, ki so jemali zdravilo {(Lastniško) ime}, kar je podobno kot v kliničnih raziskavah z drugimi zaviralci HMG CoA reduktaze.
English: Do not use any tools or machines if your ability to use them is affected by this medicine.
Slovenian: Vendar pa ne vozite avtomobila ali upravljajte orodij ali strojev, če to zdravilo vpliva na vašo sposobnost za te dejavnosti.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Slovenian: Tako ta povzetek glavnih značilnosti zdravila, označevanja in navodilo za uporabo morda ne odražajo trenutnega besedila.
English: Common: headache.
Slovenian: Pogosto: glavobol
English: Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z jetrno okvaro je treba zdravilo {(Lastniško) ime} uporabljati previdno (glejte poglavji 4.4 in 5.2).
English: • having nightmares, insomnia
Slovenian: • nočne more, nespečnost,
English: Rare: myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
Slovenian: Redko: miopatija, miozitis, rabdomioliza, tendinopatija, občasno z zapletom pretrganje tetive
English: There was no evidence of a difference in the treatment effect by patient's gender, age, or baseline LDL-C level.
Slovenian: Ni bilo dokazov, da bi se učinek zdravljenja razlikoval glede na spol bolnikov, njihovo starost ali izhodiščno koncentracijo holesterola LDL.
English: If CK 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 CK izhodiščno zelo velika (> 5-kratna ZNM), je treba CK za potrditev izvida ponovno izmeriti čez 5 do 7 dni.
English: Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137).
Slovenian: Bolnike so zdravili z antihipertenzivno terapijo (program na podlagi amlodipina ali atenolola) ter bodisi z 10 mg atorvastatina na dan (n = 5.168), bodisi s placebom (n = 5.137).
English: The mean LDL-C was 73 mg/dL (1.9 mmol/L) during treatment with atorvastatin and 129 mg/dL (3.3 mmol/L) during treatment with placebo.
Slovenian: Povprečni holesterol LDL je bil 1,9 mmol/l (73 mg/dl) med zdravljenjem z atorvastatinom in 3,3 mmol/l (129 mg/dl) med zdravljenjem s placebom.
English: Atorvastatin iiss effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid-lowering medicinal products.
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: Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with {PRODUCT NAME}.
Slovenian: Pred začetkom zdravljenja vam bo zdravnik predpisal prehrano z nizko vsebnostjo holesterola, ki se je morate držati tudi med zdravljenjem z zdravilom {(Lastniško) ime}.
English: Total mortality and cardiovascular mortality were not significantly reduced (185 vs. 212 events, p=0.17 and 74 vs. 82 events, p=0.51).
Slovenian: Celotna umrljivost in srčnožilna umrljivost se nista pomembno zmanjšali (185 dogodkov v primerjavi z 212, p=0,17, in 74 dogodkov v primerjavi z 82, p=0,51).
English: Atorvastatin was not found to be carcinogenic in rats, but high doses in mice (resulting in 6-11 fold the AUC0-24h reached in humans at the highest recommended dose) showed hepatocellular adenomas in males and hepatocellular carcinomas in females.
Slovenian: Atorvastatin za podgane ni bil karcinogen, vendar pa se je pri visokih odmerkih pri miših (na podlagi AUC(0-24) od 6- do 11-krat višja kot pri najvišjem odmerku za človeka) nastal hepatocelularni adenom pri samcih in hepatocelularni karcinom pri samicah.
English: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8).
Slovenian: Med uporabo nekaterih statinov so bili opisani izjemni primeri intersticijske bolezni pljuč, zlasti med dolgotrajnim zdravljenjem (glejte poglavje 4.8).
English: − This medicine has been prescribed for you.
Slovenian: - To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
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: Zdravilo {(Lastniško) ime} se uporablja za znižanje zvišane ravni holesterola in trigliceridov v krvi, kadar prehrana z malo maščob in spremembe življenjskega stila niso dovolj učinkovite.
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 effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomized, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
Slovenian: Učinek atorvastatina na koronarno srčno bolezen s smrtnim izidom in brez njega so ocenili v randomizirani, dvojno slepi, s placebom kontrolirani študiji ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm).
English: Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin (see Table 1 and specific information below).
Slovenian: Ugotovili so, da močni zaviralci CYP3A4 povzročajo znatno povečane koncentracije atorvastatina (glejte Preglednico 1 in specifične informacije o tem spodaj).
English: Patients were 60% male, 21-92 years of age (average age 63 years), and had an average baseline LDL of 133 mg/dL (3.4 mmol/L).
Slovenian: Med bolniki je bilo 60 % moških; starost skupine je bila od 21 do 92 let (povprečje: 63 let) in povprečni izhodiščni LDL je bil 3,4 mmol/l (133 mg/dl).
English: Atorvastatin is metabolized by cytochrome P450 3A4 to ortho- and parahydroxylated derivatives and various beta-oxidation products.
Slovenian: Atorvastatin se s citokromom P450 3A4 presnavlja v orto- in parahidroksilirane derivate in različne betaoksidacijske produkte.
English: The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.
Slovenian: Odmerek je treba določiti posamezno glede na izhodiščno koncentracijo holesterola LDL, cilj zdravljenja in bolnikov odziv.
English: Due to the dual interaction mechanism of rifampin, (cytochrome P450 3A induction and inhibition of hepatocyte uptake transporter OATP1B1), simultaneous co-administration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.
Slovenian: Zaradi dvojnega mehanizma delovanja rifampina (indukcija citokroma P450 3A in zaviranje privzema premašalca OATP1B1 v hepatocitih) se priporoča sočasna uporaba atorvastatina z rifampinom, saj je, kadar so dajali atorvastatin z zamikom po zaužitju rifampina, prišlo do znatnega zmanjšanja plazemskih koncentracij atorvastatina.
English: Triglycerides and cholesterol in the liver are incorporated into very lowdensity 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: Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
Slovenian: Zvišanje nad 10-kratno ZNM se je pojavilo pri 0,4 % bolnikov, zdravljenih z zdravilom {(Lastniško) ime} (glejte poglavje 4.4).
English: Psychiatric disorders Uncommon: nightmare, insomnia.
Slovenian: Psihiatrične motnje Občasno:nočne more, nespečnost
English: In animal studies atorvastatin had no effect on male or female fertility (see section 5.3).
Slovenian: Študije na živalih so pokazale, da atorvastatin ni vplival na moško ali žensko plodnost (glejte poglavje
English: The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, 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).
Slovenian: Učinek atorvastatina na srčnožilne 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 srčnožilne bolezni ter s koncentracijo holesterola LDL ≤ 4,14 mmol/l (160 mg/dl) in trigliceridov ≤ 6,78 mmol/l (600 mg/dl).
English: • blood test results that show your liver function can become abnormal
Slovenian: • rezultati krvnih preiskav, ki kažejo na nenormalno delovanje vaših jeter.
English: 6.6 Special precautions for disposal No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Slovenian: Atorvastatin je selektivni, kompetitivni zaviralec HMG CoA reduktaze, encima, ki omejuje hitrost pretvorbe 3-hidroksi-3-metil-glutaril-koencima A v mevalonat, ki je predhodnik sterolov, vključno s holesterolom.
English: Concomitant administration of medicinal products that are inhibitors of CYP3A4 or transport proteins may lead to increased plasma concentrations of atorvastatin and an increased risk of myopathy.
Slovenian: Sočasna uporaba zdravil, ki so zaviralci CYP3A4 ali prenašalcev, lahko privede do povečanih plazemskih koncentracij atorvastatina in povečanega tveganja za miopatijo.
English: Ezetimibe
Slovenian: Ezetimib
English: In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
Slovenian: Analiza podatkovne baze s placebom kontroliranih kliničnih preskušanj atorvastatina pri 16066 bolnikih (8755 zdravljenih z zdravilom {(Lastniško) ime} in 7311 s placebom), zdravljenih povprečno 53 tednov, je pokazala, da je zaradi neželenih učinkov zdravljenje prekinilo 5,2 % bolnikov, ki so jemali atorvastatin, in 4,0 % bolnikov, ki so jemali placebo.
English: Treatment with {PRODUCT NAME} should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant (see section 4.3.)
Slovenian: Zdravljenje z zdravilom {(Lastniško) ime} je potrebno v času nosečnosti ali dokler ni potrjeno, da ženska ni noseča (glejte poglavje 4.3) začasno prekiniti.
English: Plasma concentrations of atorvastatin and its active metabolites were lower (by approx. 25%) when colestipol was co-administered with {PRODUCT NAME}.
Slovenian: Plazemske koncentracije atorvastatina in njegovih aktivnih presnovkov so bile nižje (za približno 25 %), kadar so sočasno z zdravilom {(Lastniško) ime} uporabljali holestipol.
English: Saquinavir 400 mg BID/ Ritonavir (300 mg BID from days 5-7, increased to 400 mg BID on day 8), days 5-18, 30 min after atorvastatin dosing
Slovenian: Sakvinavir 400 mg dvakrat na dan / ritonavir (300 mg dvakrat na dan od dneva 5-7, povečati do 400 mg dvakrat na dan na dan 8), od dneva 5-18, 30 min po odmerku atorvastatina
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 zdravilo {(Lastniško) ime}.
English: − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
Slovenian: Med zdravljenjem - Bolnikom je treba naročiti, naj zdravnika takoj obvestijo o bolečinah v mišicah, krčih ali šibkosti mišic, zlasti če te simptome spremlja splošno slabo počutje ali zvišana telesna temperatura.