FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Slovenian: • bolnicah z znano preobčutljivostjo za anastrozol ali katerokoli pomožno snov v zdravilu (pomožne snovi so navedene v poglavju 6.1).
English: • Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing.
Slovenian: • alergijske (preobčutljivostne) reakcije z otekanjem žrela, ki lahko povzroči težave s požiranjem ali dihanjem.
English: The secondary objectives were to evaluate the proportion of patients with reductions from baseline in the calculated volume of gynaecomastia of both breasts combined of at least 50% between day 1 and after 6 months of study treatment, and patient tolerability and safety.
Slovenian: Sekundarni cilji so bili ocena deleža bolnikov z zmanjšanjem izračunanega volumna obeh dojk skupaj za vsaj 50 % v primerjavi z izhodiščem od 1. dne in po 6 mesecih študije, prenašanje zdravila in varnost.
English: The small change in the rate of absorption is not expected to result in a clinically significant effect on steady-state plasma concentrations during once daily dosing of Arimidex tablets.
Slovenian: Ni pričakovati, da bi majhna sprememba hitrosti absorpcije klinično pomembno vplivala na plazemsko koncentracijo v stanju dinamičnega ravnovesja med uporabo tablet zdravila Arimidex enkrat na dan.
English: • Raised or high levels of a fatty substance known as cholesterol in your blood.
Slovenian: • zvišanje koncentracije maščobe, imenovane holesterol, v krvi.
English: • Pregnant or breast-feeding women.
Slovenian: • nosečnicah in doječih ženskah.
English: For the primary endpoints, Study 1033IL/0030 showed that Arimidex had a statistically significant advantage over tamoxifen for time to tumour progression (Hazard ratio (HR) 1.42, 95% Confidence Interval (CI) [1.11, 1.82], Median time to progression 11.1 and 5.6 months for Arimidex and tamoxifen respectively, p=0.006); objective tumour response rates were similar for Arimidex and tamoxifen.
Slovenian: Kar zadeva primarne opazovane dogodke, je študija 1033IL/0030 pokazala, da je imelo zdravilo Arimidex statistično značilno prednost pred tamoksifenom za čas do napredovanja tumorja (razmerje ogroženosti (HR) 1,42, 95% interval zaupanja (IZ) [1,11, 1,82], mediana časa do napredovanja 11,1 in 5,6 mesecev za Arimidex in tamoksifen, (p = 0,006); objektivni delež odziva tumorja je bil pri zdravilu Arimidex in tamoksifenu podoben.
English: In both studies there were no significant differences between treatment arms with respect to any of the efficacy parameters.
Slovenian: V nobeni študiji ni bilo značilnih razlik med terapevtskima krakoma, kar zadeva katerikoli parameter učinkovitosti.
English: Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Slovenian: Cimetidin, ki je šibek in nespecifičen zaviralec encimov CYP, ni vplival na koncentracijo anastrozola v plazmi.
English: The primary endpoints for both trials were time to tumour progression, objective tumour response rate, and safety.
Slovenian: V obeh preskušanjih so bili primarni opazovani dogodki čas do napredovanja tumorja, objektivni delež odziva tumorja in varnost.
English: - It does not matter if you take Arimidex before, with or after food.
Slovenian: - Ni pomembno, ali zdravilo Arimidex vzamete pred jedjo, med jedjo ali po jedi.
English: Do not take Arimidex if any of the above apply to you.
Slovenian: Ne vzemite zdravila Arimidex, če kaj od naštetega velja za vas.
English: p-value Time to distant recurrenced
Slovenian: vrednost p Čas do oddaljene ponovitved
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis than in matched controls (Study 1033IL/0014).
Slovenian: Navidezni očistek (CL/F) anastrozola je bil po peroralni uporabi približno 30 % manjši pri prostovoljcih s stabilno cirozo jeter kot pri ujemajočih se kontrolnih osebah (študija 1033IL/0014).
English: No statistically significant difference from placebo was observed for the growth related parameters of predicted adult height, height, height SDS (standard deviation score), and height velocity.
Slovenian: V primerjavi s placebom niso ugotovili statistično pomembne razlike v rastnih parametrih predvidene odrasle višine, višine, standardnih odklonov višine (vrednosti po standardnih odklonih) in hitrosti rasti.
English: Myocardial infarct
Slovenian: Miokardni infarkt
English: In animal studies, anastrozole demonstrated low acute toxicity.
Slovenian: V študijah na živalih je bila akutna toksičnost anastrozola majhna.
English: Effects on your bones
Slovenian: Učinki na kosti
English: Like all medicines, Arimidex can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Arimidex neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: A total of 1,021 patients were randomised to receive 1 mg of Arimidex once daily or 20 mg of tamoxifen once daily.
Slovenian: Skupaj 1.021 bolnic so randomizirali na zdravljenje z 1 mg zdravila Arimidex enkrat na dan ali 20 mg tamoksifena enkrat na dan.
English: The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.
Slovenian: Najpogosteje opisani neželeni učinki so bili glavobol, valovi vročine, navzea, izpuščaj, artralgija, togost sklepov, artritis in astenija.
English: • Inflammation of the small blood vessels causing red or purple colouring of the skin.
Slovenian: • vnetje drobnih žil, ki povzroči rdeče ali škrlatno obarvanje kože.
English: anastrozole
Slovenian: anastrozol
English: Fractures of the spine, hip, or wrist/Colles Wrist/Colles fractures
Slovenian: Zlomi hrbtenice, kolka ali zapestja/Collesovi zlomi Zlomi zapestja/Collesovi zlomi Zlomi hrbtenice
English: Each film-coated tablet contains 1 mg of anastrozole.
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg anastrozola.
English: Patients in the low risk group received Arimidex alone (N=42), those in the moderate group were randomised to Arimidex plus risedronate 35 mg once a week (N=77) or Arimidex plus placebo (N=77) and those in the high risk group received Arimidex plus risedronate 35 mg once a week (N=38).
Slovenian: Bolnice v skupini z majhnim tveganjem so dobile samo zdravilo Arimidex (n = 42), bolnice v skupini z zmernim tveganjem so randomizirali na zdravilo Arimidex in risedronat 35 mg enkrat na teden (n = 77) ali na zdravilo Arimidex in placebo (n = 77), bolnice v skupini z velikim tveganjem pa so dobile zdravilo Arimidex in risedronat 35 mg enkrat na teden (n = 38).
English: - 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.
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: A two-year mouse oncogenicity study resulted in the induction of benign ovarian tumours and a disturbance in the incidence of lymphoreticular neoplasms (fewer histiocytic sarcomas in females and more deaths as a result of lymphomas).
Slovenian: Dveletna študija onkogenosti na miših je povzročila indukcijo benignih tumorjev jajčnika in motnje v incidenci limforetikularnih novotvorb (manj histiocitnih sarkomov pri ženskah in več smrti zaradi limfomov).
English: Table 2 ATAC study pre-specified adverse events Adverse events
Slovenian: Preglednica 2 Vnaprej opredeljeni neželeni učinki v študiji ATAC Neželeni učinki
English: Arimidex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Slovenian: Zdravila Arimidex ni priporočljivo uporabljati pri otrocih in mladostnikih, ker njegova varnost in učinkovitost v tej skupini bolnikov nista ugotovljeni (glejte poglavje 5.1).
English: Clinical trials have been conducted with various dosages of Arimidex, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
Slovenian: Klinična preskušanja so bila opravljena z različnimi odmerjanji zdravila Arimidex do 60 mg v enkratnem odmerku, uporabljenem pri zdravih moških prostovoljcih, in do 10 mg na dan pri ženskah po menopavzi z napredovalim rakom dojke; preiskovane osebe so ta odmerjanja dobro prenesle.
English: The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.
Slovenian: Spodnja preglednica prikazuje pogostnost vnaprej opredeljenih neželenih učinkov v študiji ATAC po mediano 68-mesečnem spremljanju (ne glede na vzročnost), zabeleženih pri osebah, ki so prejemale raziskovano zdravilo in do 14 dni po prenehanju njegove uporabe.
English: Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer.
Slovenian: Zmanjšanje koncentracije estradiola v obtoku ima pri ženskah z rakom dojke dokazano ugoden vpliv.
English: There were no clinically significant interactions with bisphosphonates (see section 5.1).
Slovenian: Klinično pomembnih medsebojnih delovanj z difosfonati ni bilo (glejte poglavje 5.1).
English: • Changes in blood tests that show how well your liver is working.
Slovenian: • spremembe izvidov preiskav krvi, ki kažejo delovanje jeter
English: A single dose of Arimidex that results in life-threatening symptoms has not been established.
Slovenian: Posamičen odmerek zdravila Arimidex, ki bi povzročil življensko nevarne simptome, ni ugotovljen.
English: In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.
Slovenian: V študiji akutne peroralne toksičnosti na psih je bil mediani smrtni odmerek večji od 45 mg/kg/dan.
English: Unless specified, the frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer given adjuvant treatment for five years (the Arimidex, Tamoxifen, Alone or in Combination [ATAC] study).
Slovenian: Če ni navedeno drugače, so bile kategorije pogostnosti izračunane na podlagi števila neželenih učinkov, zabeleženih v veliki študiji III. faze, ki je zajela 9.366 žensk po menopavzi, ki so imele operabilnega raka dojke in so pet let prejemale adjuvantno zdravljene (študija ATAC [Arimidex, Tamoxifen, Alone or in Combination]).
English: Gynaecomastia studies
Slovenian: Študije ginekomastije
English: In animal studies adverse effects were only seen at high doses.
Slovenian: V študijah na živalih so neželene učinke opažali le pri velikih odmerkih.
English: Arimidex is not indicated for use in children and adolescents.
Slovenian: Zdravilo Arimidex ni indicirano za uporabo pri otrocih in mladostnikih.
English: If you forget to take Arimidex
Slovenian: Če ste pozabili vzeti zdravilo Arimidex
English: The Arimidex safety profile in these 3 studies was consistent with the known safety profile established in postmenopausal women with hormone receptor-positive early breast cancer.
Slovenian: Varnostne značilnosti zdravila Arimidex v teh 3 študijah so se skladale z znanimi varnostnimi značilnostmi, ugotovljenimi pri ženskah po menopavzi, ki so imele zgodnjega raka dojke s pozitivnimi hormonskimi receptorji.
English: Arimidex is indicated for the:
Slovenian: Zdravilo Arimidex je indicirano za:
English: - The active substance is anastrozole.
Slovenian: - Zdravilna učinkovina je anastrozol.
English: What Arimidex looks like and contents of the pack
Slovenian: Izgled zdravila Arimidex in vsebina pakiranja
English: These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant to the treatment of patients with anastrozole.
Slovenian: Te spremembe veljajo za učinke zavrtja aromataze, ki so specifični za miši, in ne veljajo za klinično pomembne pri zdravljenju bolnikov z anastrozolom.
English: Before treatment with Arimidex check with your doctor or pharmacist - if you still have menstrual periods and have not yet gone through the menopause.
Slovenian: Bodite posebno pozorni pri uporabi zdravila Arimidex Pred zdravljenjem z zdravilom Arimidex se posvetujte z zdravnikom ali s farmacevtom - če še imate menstruacije in še niste imeli menopavze.
English: • Trigger finger (a condition in which your finger or thumb catches in a bent position).
Slovenian: • sprožilni prst (motnja, pri kateri se kateri od prstov na roki zaskoči v upognjenem položaju)
English: Do not take Arimidex - if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Arimidex (see section 6: Further information).
Slovenian: Ne jemljite zdravila Arimidex - če ste alergični (preobčutljivi) na anastrozol ali katerokoli sestavino zdravila Arimidex (glejte poglavje
English: Vomiting may be induced if the patient is alert.
Slovenian: Če je bolnik priseben, se lahko izzove bruhanje.
English: Genetic toxicology studies with anastrozole show that it is not a mutagen or a clastogen.
Slovenian: Študije genotoksičnosti anastrozola kažejo, da ni mutagen ali klastogen.
English: Arimidex does not possess any progestogenic, androgenic, or estrogenic activity.
Slovenian: Zdravilo Arimidex ne deluje progestagensko, androgensko ali estrogensko.
English: Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation.
Slovenian: Presnova anastrozola poteka z N-dealkilacijo, hidroksilacijo in glukuronidacijo.
English: Very common Arthralgia/joint stiffness Arthritis
Slovenian: Zelo pogosti artralgija/togost sklepov artritis osteoporoza
English: - if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Taking other medicines').
Slovenian: - če jemljete kakšno zdravilo, ki vsebuje tamoksifen, ali zdravila, ki vsebujejo estrogene (glejte poglavje
English: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom
Slovenian: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, Velika Britanija
English: Myocardial ischaemia
Slovenian: Ishemija miokarda
English: Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Slovenian: Zdravila Arimidex se ne sme uporabljati pri dečkih s pomanjkanjem rastnega hormona poleg zdravljenja z rastnim hormonom.
English: Table 1 Adverse reactions by System Organ Class and frequency Adverse reactions by SOC and frequency Metabolism and nutrition disorders Common
Slovenian: Preglednica 1 Neželeni učinki po organskih sistemih in pogostnosti Neželeni učinki po organskih sistemih in pogostnosti Presnovne in prehranske motnje
English: Trial 0046 was an international, multi-centre, open-label exploratory trial of Arimidex in 28 girls (aged 2 to ≤ 10 years) with McCune-Albright Syndrome (MAS).
Slovenian: Preskušanje 0046 je bilo mednarodno, multicentrično, odprto eksplorativno preskušanje zdravila Arimidex pri 28 deklicah (starih od 2 do ≤ 10 let) z McCune-Albrightovim sindromom (MAS).
English: The observed fracture rate for Arimidex is similar to the range reported in age-matched postmenopausal populations.
Slovenian: Z zdravilom Arimidex opaženi delež zlomov je podoben razponu, opisanemu za starostno usklajene populacije po menopavzi.
English: Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).
Slovenian: Preživetje brez oddaljene bolezni je opredeljeno kot prvi pojav oddaljene ponovitve ali smrti (zaradi kateregakoli vzroka).
English: Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Slovenian: Anastrozol zmanjša koncentracijo estradiola, zato se zdravila Arimidex ne sme uporabljati pri deklicah s pomanjkanjem rastnega hormona poleg zdravljenja z rastnim hormonom.
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the Arimidex arm compared to placebo.
Slovenian: Število zdravljenih otrok je bilo sicer premajhno za zanesljive sklepe o varnosti, vendar so v kraku z zdravilom Arimidex v primerjavi s placebom opazili večji delež zlomov in trend k manjši mineralni gostoti kosti.
English: Mood disturbances
Slovenian: Motnje razpoloženja
English: No no-effect levels were established for anastrozole in the toxicity studies, but those effects that were observed at the low doses (1 mg/kg/day) and mid doses (dog 3 mg/kg/day; rat 5 mg/kg/day) were related to either the pharmacological or enzyme inducing properties of anastrozole and were unaccompanied by significant toxic or degenerative changes.
Slovenian: Toda učinki, opaženi z majhnimi odmerki (1 mg/kg/dan) in srednjimi odmerki (3 mg/kg/dan pri psih, 5 mg/kg/dan pri podganah) so bili povezani bodisi s farmakološkimi učinki anastrozola ali učinki anastrozola na indukcijo encimov in jih niso spremljale pomembne toksične ali degenerativne spremembe.
English: Arimidex is used to treat breast cancer in women who have gone through the menopause.
Slovenian: Zdravilo Arimidex se uporablja za zdravljenje raka dojke pri ženskah, ki so že imele menopavzo.
English: Arimidex is contraindicated during pregnancy (see section 4.3).
Slovenian: Zdravilo Arimidex je med nosečnostjo kontraindicirano (glejte poglavje 4.3).
English: [See Annex I - To be completed nationally] This leaflet was last approved in {MM/YYYY}.
Slovenian: [Glejte Dodatek I - izpolni država članica] Navodilo je bilo odobreno {MM/LLLL}.
English: The survival of litters born to rats given anastrozole at 0.02 mg/kg/day and above (from Day 17 of pregnancy to Day 22 post-partum) was compromised.
Slovenian: Preživetje legel, skotenih podganam, ki so dobivale odmerke anastrozola 0,02 mg/kg/dan in več (od 17. dne brejosti do 22. postpartalnega dneva), je bilo slabše.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2 to 9 years) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Slovenian: Odprta, neprimerjalna, multicentrična študija je ocenila 14 bolnikov moškega spola (starih od 2 do 9 let) z družinsko, na moške omejeno prezgodnjo puberteto (znano tudi kot testotoksikoza), zdravljenih s kombinacijo zdravila Arimidex in bikalutamida.
English: No statistically significant change in the rate of increase in bone age on treatment compared to the rate during baseline was observed.
Slovenian: Opazili niso nobene statistično značilne spremembe v hitrosti povečanja kostne starosti med zdravljenjem v primerjavi z izhodiščno hitrostjo.
English: However, plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
Slovenian: Toda koncentracija anastrozola v plazmi je bila pri prostovoljcih s cirozo jeter znotraj območja koncentracij, zabeleženih pri normalnih preiskovancih v drugih preskušanjih.
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was not altered in volunteers with severe renal impairment (GFR <30ml/min) in Study 1033IL/0018, consistent with the fact that anastrozole is eliminated primarily by metabolism.
Slovenian: Navidezni očistek (CL/F) anastrozola po peroralni uporabi pri prostovoljcih s hudo okvaro ledvic (hitrost glomerularne filtracije < 30 ml/min) v študiji 1033IL/0018 ni bil drugačen; to se sklada z dejstvom, da se anastrozol odstrani predvsem s presnovo.
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Slovenian: V študiji plodnosti so nedavno odstavljenim podganjim samcem 10 tednov peroralno dajali 50 ali 400 mg/l anastrozola v pitni vodi.
English: In the phase III/IV study (Study of Anastrozole with the Bisphosphonate Risedronate [SABRE]), 234 postmenopausal women with hormone receptor-positive early breast cancer scheduled for treatment with Arimidex 1 mg/day were stratified to low, moderate and high risk groups according to their existing risk of fragility fracture.
Slovenian: faze SABRE (Study of Anastrozole with the Bisphosphonate Risedronate) so 234 žensk po menopavzi z zgodnjim rakom dojke in pozitivnimi hormonskimi receptorji, ki so bile predvidene za zdravljenje z zdravilom Arimidex 1 mg/dan, razporedili v skupine z majhnim, zmernim in velikim tveganjem glede na njihovo obstoječe tveganje za zlom zaradi krhkosti.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Arimidex.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Arimidex.
English: How to store Arimidex Further information
Slovenian: Shranjevanje zdravila Arimidex Dodatne informacije
English: The use of specific treatments, e.g., bisphosphonates, may stop further bone mineral loss caused by Arimidex in postmenopausal women and could be considered (see section 4.8).
Slovenian: Uporaba specifičnih zdravil, npr. difosfonatov, lahko prepreči nadaljnje zmanjševanje mineralne gostote kosti, ki jo pri ženskah po menopavzi povzroči zdravilo Arimidex, zato pride v poštev (glejte poglavje 4.8).
English: Exposure to anastrozole is not increased in subjects with severe renal impairment (GRF<30ml/min, see section 5.2); in patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2).
Slovenian: Izpostavljenost anastrozolu se pri osebah s hudo okvaro ledvic ne poveča (GRF<30ml/min, glejte poglavje 5.2); pri bolnicah s hudo okvaro ledvic je treba zdravilo Arimidex uporabljati previdno (glejte poglavje 4.2).
English: • Bone loss (osteoporosis).
Slovenian: • redčenje kosti (osteoporoza)
English: There are no data from the use of Arimidex in pregnant women.
Slovenian: Podatkov o uporabi zdravila Arimidex pri nosečnicah ni.
English: • Rare inflammation of your skin that may include red patches or blisters.
Slovenian: • redko vnetje kože, ki lahko obsega rdeče lise ali mehurje
English: Arimidex is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Slovenian: Zdravila Arimidex zaradi nezadostnih podatkov o varnosti in učinkovitosti ni priporočljivo uporabljati pri otrocih in mladostnikih (glejte poglavji 4.4 in 5.1).
English: Advanced breast cancer
Slovenian: Napredovali rak dojke
English: Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.
Slovenian: Čas do oddaljene ponovitve je opredeljen kot prvi pojav oddaljene ponovitve ali smrti zaradi raka dojke.
English: Arimidex is not likely to affect your ability to drive or use any tools or machines.
Slovenian: Ni verjetno, da bi zdravilo Arimidex vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
English: Trial 0001 was an open-label, multiple-dose pharmacokinetic study of Arimidex 1 mg/day in 36 pubertal boys with gynaecomastia of less than 12 months duration.
Slovenian: Preskušanje 0001 je bilo odprta študija farmakokinetike več odmerkov 1 mg zdravila Arimidex na dan pri 36 pubertetnih dečkih z ginekomastijo, ki je trajala manj kot 12 mesecev.