FrancophonIA/ELRC3.0 huggingface dataset:
English: LIPITOR and associated names (see Annex I) 10 mg film-coated tablets LIPITOR and associated names (see Annex I) 20 mg film-coated tablets LIPITOR and associated names (see Annex I) 40 mg film-coated tablets LIPITOR and associated names (see Annex I) 80 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: LIPITOR in povezana imena (glejte Dodatek 1) 10 mg filmsko obložene tablete LIPITOR in povezana imena (glejte Dodatek 1) 20 mg filmsko obložene tablete LIPITOR in povezana imena (glejte Dodatek 1) 40 mg filmsko obložene tablete LIPITOR in povezana imena (glejte Dodatek 1) 80 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica]
English: 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).
Slovenian: 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).
English: In cases where co-administration of these medicinal products with atorvastatin cannot be avoided lower starting and maximum doses of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended (see Table 1).
Slovenian: V primerih, ko se sočasni uporabi teh zdravil z atorvastatinom ne moremo izogniti, je potrebno razmisliti o znižanju začetnih in najvišjih odmerkov atorvastatina, priporočeno pa je tudi ustrezno klinično spremljanje bolnika (glejte Preglednico 1).
English: Very rare: anaphylaxis.
Slovenian: Zelo redko: odpoved jeter
English: Co-administered medicinal product and dosing regimen
Slovenian: Sočasno uporabljeno zdravilo in režim odmerjanja
English: 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).
Slovenian: 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).
English: • hearing loss
Slovenian: • izguba sluha,
English: The usual starting dose is 10 mg once a day.
Slovenian: Običajni začetni odmerek je 10 mg zdravila {(Lastniško) ime} enkrat na dan.
English: Liver effects
Slovenian: Učinki na jetra
English: Clarithromycin 500 mg BID, 9 days
Slovenian: Klaritromicin 500 mg dvakrat na dan, 9 dni
English: Rare: angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Slovenian: Občasno: urtikarija, kožni izpuščaj, pruritus, alopecija Redko: angionevrotični edem, bulozni izpuščaji (vključno z multiformnim eritemom, StevensJohnsonovim sindromom in toksično epidermalno nekrolizo)
English: 100 vs. 154 389 vs. 483
Slovenian: 389 v primerjavi s 483
English: 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 (Child-Pugh B).
Slovenian: 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).
English: 4.7 Effects on ability to drive and use machines {PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo {(Lastniško) ime} ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: If CK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
Slovenian: Če je vrednost CK izhodiščno zelo velika (> 5-kratna ZNM), zdravljenja ne začnemo.
English: • cholestasis (yellowing of the skin and whites of the eyes) • tendon injury
Slovenian: • zastoj žolča (rumeno obarvanje kože in očesne beločnice),
English: At atorvastatin doses exceeding 20 mg, clinical monitoring of these patients is recommended.
Slovenian: Pri odmerkih atorvastatina, ki so večji kot 20 mg, je priporočeno klinično spremljanje teh bolnikov.
English: Do not use {PRODUCT NAME} after the expiry date which is stated on the container and outer packaging after {EXP}.
Slovenian: Zdravila {(Lastniško) ime} ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: Co-administration of potent CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided if possible.
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A4 (n. pr. ciklosporina, telitromicina, klaritromicina, delavirdina, stiripentola, ketokonazola, vorikonazola, itrakonazola, posakonazola in zaviralcev proteaze HIV, vključno z ritonavirjem, lopinavirjem, atazanavirjem, indinavirjem, darunavirjem itd.) se je treba, če je le mogoče, izogibati.
English: • dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch,
Slovenian: • vrtoglavica, otrplost ali mravljinčenje v prstih na rokah in nogah, zmanjšana občutljivost na dotik ali bolečino, spremembe okušanja, izguba spomina,
English: Nelfinavir 1250 mg BID, 14 days
Slovenian: Nelfinavir 1250 mg dvakrat na dan, 14 dni
English: The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis.
Slovenian: Uporaba fibratov brez drugih zdravil je občasno povezana z neželenimi učinki na mišice, vključno z rabdomiolizo.
English: • Sexual difficulties
Slovenian: • spolna nezmožnost,
English: The effect of intensive lipid lowering on cardiovascular endpoints (e. g. need for revascularisation, non fatal myocardial infarction, coronary death) was not investigated in this study.
Slovenian: V študiji niso raziskovali učinka intenzivnega nižanja lipidov na srčnožilne opazovane dogodke (tj. potrebo po revaskularizaciji, miokardni infarkt brez smrtnega izida, koronarno smrt).
English: HOW TO TAKE {PRODUCT NAME}
Slovenian: KAKO JEMATI ZDRAVILO {(LASTNIŠKO) IME}
English: * Phenazone, 600 mg SD ↑ 3% No specific recommendation
Slovenian: * Fenazon, 600 mg enkratni odmerek
English: If these levels are found to be significantly elevated (> 5 times ULN), treatment should be stopped.
Slovenian: Če je vrednost CK pomembno zvišana (> 5-kratna ZNM), je treba zdravljenje prekiniti.
English: In rats, plasma concentrations of atorvastatin are similar to those in milk.
Slovenian: Koncentracija atorvastatina v mleku podgan je bila približno enaka kot v plazmi.
English: Both amiodarone and verapamil are known to inhibit CYP3A4 activity and co-administration with atorvastatin may result in increased exposure to atorvastatin.
Slovenian: Znano je, da tako amiodaron kot verapamil zavirata delovanje CYP3A4, in tako bi njuna sočasna uporaba z atorvastatinom utegila privesti do povečane izpostavljenosti atorvastatinu.
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo odobreno {MM/LLLL} [Izpolni država članica]
English: {PRODUCT NAME} is contraindicated in patients with active liver disease (see section 4.3).
Slovenian: Zdravilo {(Lastniško) ime} je kontraindicirano pri bolnikih z aktivno boleznijo jeter (glejte poglavje
English: At atorvastatin doses exceeding 40 mg, clinical monitoring of these patients is recommended.
Slovenian: Pri odmerkih atorvastatina, ki so večji kot 40 mg, je priporočeno klinično spremljanje teh bolnikov.
English: Other possible side effects with {PRODUCT NAME}:
Slovenian: Ostali možni neželeni učinki pri jemanju zdravila {(Lastniško) ime}:
English: 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.
Slovenian: 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.
English: If concomitant administration cannot be avoided, the lowest dose of atorvastatin to achieve the therapeutic objective should be used and the patients should be appropriately monitored (see section
Slovenian: Če se sočasni uporabi ne moremo izogniti, moramo uporabiti najnižji odmerek atorvastatina, ki še doseže terapevtski učinek, takšne bolnike pa je potrebno ustrezno spremljati (glejte poglavje 4.4).
English: Homozygous familial hypercholesterolaemia
Slovenian: Homozigotna familiarna hiperholesterolemija
English: Tipranavir 500 mg BID/ Ritonavir 200 mg BID, 8 days (days 14 to 21)
Slovenian: Tipranavir 500 mg dvakrat na dan / ritonavir 200 mg dvakrat na dan, 8 dni (od dneva 14 do
English: Atorvastatin was administered at doses up to 80 mg/day.
Slovenian: Uporabljali so odmerke atorvastatina do 80 mg na dan.
English: All cause mortality was 15.6% (7/45) for atorvastatin versus 10.4% (5/48) in the subgroup of patients with prior hemorrhagic stroke.
Slovenian: V podskupini bolnikov s predhodno hemoragično možgansko kapjo je bila umrljivost zaradi vseh vzrokov z atorvastatinom 15,6 % (7/45) v primerjavi z 10,4 % (5/48).
English: • fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
Slovenian: • utrujenost, slabo počutje, bolečina v prsih, otekanje, zlasti gležnjev (edem), zvišana telesna temperatura,
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država članica]
English: Fenofibrate 160 mg OD, 7 days
Slovenian: Fenofibrat 160 mg enkrat na dan, 7 dni
English: Atorvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.
Slovenian: Pri bolnikih, ki se zdravijo z atorvastatinom, vendar pa ne jemljejo antikoagulantov, niso opazili krvavitev ali sprememb protrombinskega časa.
English: Rifampin 600 mg OD, 7 days (co-administered)
Slovenian: Rifampin 600 mg enkrat na dan , 7 dni (sočasna uporaba)
English: Low-density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Slovenian: Razgradijo se predvsem prek receptorja z veliko afiniteto za LDL (receptor LDL).
English: Amlodipine 10 mg, single dose 80 mg, SD ↑ 18% No specific recommendation.
Slovenian: Amlodipin 10 mg, enkratni odmerek
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior hemorrhagic stroke (7/45 for atorvastatin versus 2/48 for placebo; HR 4.06; 95% CI, 0.84-19.57), and the risk of ischemic stroke was similar between groups (3/45 for atorvastatin versus 2/48 for placebo; HR 1.64; 95% CI, 0.27-9.82).
Slovenian: • Tveganje za hemoragično možgansko kap je bilo večje pri bolnikih, ki so imeli pred vstopom v študijo hemoragično možgansko kap (7/45 za atorvastatin in 2/48 za placebo, razmerje tveganja 4,06, 95 % IZ, 0,94-19,57), tveganje za ishemično možgansko kap pa je bilo med skupinama podobno (3/45 za atorvastatin in 2/48 za placebo, razmerje tveganja 1,64, 95 % IZ, 0,27-9,82).
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior lacunar infarct (20/708 for atorvastatin versus 4/701 for placebo; HR 4.99; 95% CI, 1.71-14.61), but the risk of ischemic stroke was also decreased in these patients (79/708 for atorvastatin versus 102/701 for placebo; HR 0.76; 95% CI, 0.57-1.02).
Slovenian: • Tveganje za hemoragično možgansko kap je bilo večje pri bolnikih, ki so imeli pred vstopom v študijo lakunaren infarkt (20/708 za atorvastatin in z 4/701 za placebo, razmerje tveganja 4,99, 95 % IZ, 1,71-14,61), vendar je bilo pri teh bolnikih hkrati manjše tveganje za ishemično možgansko kap (79/708 za atorvastatin in 102/701 za placebo, razmerje tveganja 0,76, 95 % IZ, 0,57-1,02).
English: Immune system disorders Common: allergic reactions.
Slovenian: Bolezni imunskega sistema Pogosto: alergijske reakcije Zelo redko: anafilaksija
English: [See Annex I - To be completed nationally]
Slovenian: [glejte Dodatek I - Izpolni država članica]
English: ↑ 5.9 fold
Slovenian: 5,9-krat ↑
English: In vitro, inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin.
Slovenian: Orto- in parahidroksilirani presnovki in vitro zavirajo HMG CoA reduktazo enako kot atorvastatin.
English: Erythromycin 500 mg QID, 7 days
Slovenian: Eritromicin 500 mg štirikrat na dan, 7 dni
English: Musculoskeletal and connective tissue disorders Common: myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosto: mialgija, artralgija, bolečina v okončini, mišični krči, oteklost sklepov, bolečine v hrbtu Občasno: bolečina v vratu, utrujenost mišic
English: Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Slovenian: Atorvastatin zniža koncentracijo holesterola v plazmi in lipoproteinov v serumu tako, da zavre HMG CoA reduktazo, s čimer zavre biosintezo holesterola v jetrih.
English: Cimetidine 300 mg QID, 2 weeks
Slovenian: Cimetidin 300 mg štirikrat na dan, 2 tedna
English: Colestipol
Slovenian: Holestipol
English: The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with atenolol (HR 0.83 (0.59-1.17), p=0.287).
Slovenian: Atorvastatin je pomembno zmanjšal pojavnost primarnega opazovanega dogodka (koronarna srčna bolezen s smrtnim izidom in miokardni infarkt brez smrtnega izida) pri bolnikih, ki so se zdravili z amlodipinom (razmerje tveganja 0,47 (0,32-0,69), p=0,00008), ne pa tudi pri tistih, ki so se zdravili z atenololom (razmerje tveganja 0,83 (0,59-1,17), p=0,287).
English: Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Slovenian: Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija Pri večini bolnikov se stanje uredi z 10 mg zdravila {(Lastniško) ime} enkrat na dan. Terapevtski odziv je opazen že v 2 tednih, največji odziv pa se ponavadi pokaže v 4 tednih.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally]
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi [Izpolni država članica] 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.
English: Table 2: Effect of atorvastatin on the pharmacokinetics of co-administered medicinal products
Slovenian: Preglednica 2: Učinek atorvastatina na farmakokinetiko sočasno uporabljenih zdravil Sočasno uporabljeno zdravilo
English: Paediatric use should only be carried out by specialists.
Slovenian: Otroke mora zdraviti specialist.
English: Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, verapamil and fluconazole) may increase plasma concentrations of atorvastatin (see Table 1).. An increased risk of myopathy has been observed with the use of erythromycin in combination with statins.
Slovenian: Zmerno močni zaviralci CYP3A4 (n. pr. eritromicin, diltiazem, verapamil in flukonazol) lahko povečajo plazemske koncentracije atorvastatina (glejte Preglednico 1).
English: • joint pain, muscle pain and back pain
Slovenian: • bolečine v sklepih, bolečine v mišicah in v hrbtu,
English: All cause mortality was 10.9% (77/708) for atorvastatin versus 9.1% (64/701) for placebo in the subgroup of patients with prior lacunar infarct.
Slovenian: V podskupini bolnikov s predhodnim lakunarnim infarktom je bila umrljivost zaradi vseh vzrokov z atorvastatinom 10,9 % (77/708) in s placebom 9,1 % (64/701).
English: − The active substance is atorvastatin.
Slovenian: Kaj vsebuje zdravilo {(Lastniško) ime} - Zdravilna učinkovina je atorvastatin.
English: 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}
Slovenian: DRUGI PODATKI {Za pretisni omot po 7 tablet - okrajšave/kratice dni v tednu so lahko natisnjene na foliji za vsako tableto t.j.
English: − Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
Slovenian: zdravila, ki uravnavajo vaš srčni ritem, npr. digoksin, verapamil, amiodaron - zdravila, ki se uporabljajo proti virusu HIV npr. ritonavir, lopinavir, atazanavir, indinavir, darunavir,
English: Please ask your doctor if you think that the effect of {PRODUCT NAME} is too strong or too weak.
Slovenian: Če menite, da je učinek zdravila {(Lastniško) ime} premočan ali prešibak, se posvetujte z zdravnikom.
English: Respiratory, thoracic and mediastinal disorders: Common: pharyngolaryngeal pain, epistaxis.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosto: faringo-laringealna bolečina, epistaksa
English: Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin Atorvastatin
Slovenian: Preglednica 1: medsebojno delovanje sočasno uporabljenih zdravil na farmakokinetiko atorvastatina
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: SEZNAM POMOŽNIH SNOVI [Izpolni država članica]
English: NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [glejte Dodatek I - Izpolni država članica] {Ime}
English: The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Slovenian: Pred začetkom zdravljenja z zdravilom {(Lastniško) ime} je treba bolniku predpisati standardno dieto za znižanje holesterola, ki jo mora nadaljevati tudi med zdravljenjem z zdravilom {(Lastniško) ime}.
English: Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change).
Slovenian: Podatki podani v % spremembe predstavljajo % spremembe glede na uporabo samega atorvastatina (t.j.
English: − Atorvastatin must be discontinued if clinically significant elevation of CK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
Slovenian: - Če se pojavi klinično pomembno zvišanje CK (> 10-kratna ZNM), če je diagnosticirana rabdomioliza, ali če obstaja sum nanjo, je treba uporabo atorvastatina prekiniti.
English: ↑ 1.7 fold^ No specific recommendation
Slovenian: 1,7-krat ↑^ Ni posebnega priporočila.
English: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for {PRODUCT NAME}.
Slovenian: Naslednja tabela prikazuje profil neželenih učinkov zdravila {(Lastniško) ime} na podlagi podatkov iz kliničnih raziskav in obsežnih pomarketinških izkušenj.
English: Effect of atorvastatin on co-administered medicinal products
Slovenian: Učinek atorvastatina na sočasno uporabljena zdravila
English: & Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change)
Slovenian: & Podatki podani v % spremembe predstavljajo % spremembe glede na uporabo samega atorvastatina (t.j.
English: Gemfibrozil 600 mg BID, 7 days
Slovenian: Gemfibrozil 600 mg dvakrat na dan, 7 dni
English: Therefore, a lower maximum dose of atorvastatin should be considered and appropriate clinical monitoring of the patient is recommended when concomitantly used with moderate CYP3A4 inhibitors.
Slovenian: Zato je, kadar atorvastatin uporabljamo skupaj z zmerno močnimi zaviralci CYP3A4, potrebno razmisliti o nižjem najvišjem odmerku atorvastatina, priporoča pa se tudi ustrezno klinično spremljanje bolnika.
English: Infections and infestations: Common: nasopharyngitis.
Slovenian: Infekcijske in parazitske bolezni Pogosto: nazofaringitis
English: Atorvastatin is eliminated primarily in bile following hepatic and/or extrahepatic metabolism.
Slovenian: Atorvastatin se po presnovi v jetrih in/ali zunaj jeter izloči predvsem z žolčem.
English: Darunavir 300 mg BID/ Ritonavir 100 mg BID, 9 days
Slovenian: Darunavir 300 mg dvakrat na dan / ritonavir 100 mg dvakrat na dan, 9 dni
English: • visual disturbance
Slovenian: • zamegljen vid,
English: Metabolism and nutrition disorders Common: hyperglycaemia.
Slovenian: Presnovne in prehranske motnje Pogosto: hiperglikemija
English: {PRODUCT NAME} is for oral administration.
Slovenian: Zdravilo {(Lastniško) ime} je uporablja peroralno.
English: Atorvastatin is contraindicated during breastfeeding (see section
Slovenian: Atorvastatin je kontraindiciran med dojenjem (glejte poglavje 4.3).
English: In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina).
Slovenian: V raziskavi MIRACL so pri 3.086 bolnikih (atorvastatin n = 1.538; placebo n = 1.548) z akutnim koronarnim sindromom (miokardni infarkt brez zobca Q in nestabilna angina pektoris) ovrednotili zdravljenje z atorvastatinom 80 mg. Z zdravljenjem so pričeli med akutno fazo po sprejemu v bolnišnico in je trajalo 16 tednov.
English: The dose may be increased to 80 mg daily, according to the response and tolerability.
Slovenian: Priporočeni začetni odmerek pri tej populaciji je 10 mg atorvastatina na dan. Odmerek je mogoče glede na odziv in prenašanje zvečati do 80 mg na dan.
English: 10 mg OD for 28 days
Slovenian: 10 mg enkrat na dan, 28 dni
English: Very rare side effects (affects less than 1 user in 10,000) include:
Slovenian: Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10.000 bolnikov) so:
English: Fosamprenavir 1400 mg BID, 14 days
Slovenian: Fosamprenavir 1400 mgdvakrat na dan, 14 dni
English: 40 mg OD for 22 days
Slovenian: 40 mg enkrat na dan, 22 dni
English: No. of Events (Atorvastatin vs Placebo)
Slovenian: dogodek relativno zmanjšanje tveganja št. dogodkov (atorvastatin v primerjavi s placebom)
English: ↑ 2.5 fold
Slovenian: 2,5-krat ↑
English: HOSPITAL PACK LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI škatla bolnišnično pakiranje
English: − The other ingredients of {PRODUCT NAME} are: [To be completed nationally]
Slovenian: - Pomožne snovi so: [Izpolni država članica]
English: 80 mg OD for 8 days
Slovenian: 80 mg enkrat na dan, 8 dni
English: − Renal impairment
Slovenian: Ledvično okvara
English: Atorvastatin 80 mg reduced the risk of the primary endpoint of fatal or non-fatal stroke by 15% (HR 0.85; 95% CI, 0.72-1.00; p=0.05 or 0.84; 95% CI, 0.71-0.99; p=0.03 after adjustment for baseline factors) compared to placebo.
Slovenian: 0,72-1,00; p = 0,05 ali 0,84; 95 % IZ, 0,71-0,99; p = 0,03 po prilagoditvi za izhodiščne dejavnike).
English: Study results were obtained with the 80 mg dose strength.
Slovenian: Rezultate študije so dobili z odmerkom 80 mg, zato jih ni mogoče ekstrapolirati na nižje odmerke.
English: Uncommon: dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia.
Slovenian: Občasno: omotica, parestezija, hipestezija, dizgevzija, amnezija Redko: periferna nevropatija