natgillin/translations-raw huggingface dataset:
WHAT ARIMIDEX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ARIMIDEX IN ZA KAJ GA UPORABLJAMO
Daily doses of Arimidex up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard adrenocorticotrophic hormone (ACTH) challenge testing.
Dnevni odmerki zdravila Arimidex do 10 mg ne vplivajo na izločanje kortizola ali aldosterona, merjeno pred ali po standardnem provokacijskem testiranju z adrenokortikotropnim hormonom (ACTH).
Do not take Arimidex if you are already taking any of the following medicines: - Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines that contain tamoxifen.
Ne jemljite zdravila Arimidex, če že jemljete katero od naslednjih zdravil: - Določena zdravila za zdravljenje raka dojke (selektivni modulatorji estrogenskih receptorjev), npr.
However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving or operating machinery while such symptoms persist.
Vendar sta bili med uporabo zdravila Arimidex opisani astenija in zaspanost, zato je pri vožnji in upravljanju strojev potrebna previdnost, dokler trajajo takšni simptomi.
The effects of Arimidex on fertility in humans have not been studied.
Vplivi zdravila Arimidex na plodnost pri človeku niso raziskani.
- The usual dose is one tablet once a day.
- Običajen odmerek je ena tableta enkrat na dan. - Tableto po možnosti vzemite vsak dan ob istem času.
The reduction was transient as all mating and fertility parameters were similar to control group values following a 9 week treatment-free recovery period.
Zmanjšanje je bilo prehodno, ker so bile po 9 tednih brez uporabe zdravila vrednosti vseh parametrov parjenja in plodnosti podobne kot v kontrolni skupini.
Number of events (frequency) Arimidex (N=1,297)
Število dogodkov (pogostnost) Arimidex (n = 1.297)
0.70 to 1.00
0,70 do 1,00
Cutaneous vasculitis (including some reports of Henoch-Schönlein purpura)**
Redki multiformni eritem anafilaktoidna reakcija kožni vaskulitis (vključno z nekaterimi primeri Henoch-Schönleinove purpure)**
Arimidex has no or negligible influence on the ability to drive and use machines.
Zdravilo Arimidex nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The combination of Arimidex and tamoxifen did not demonstrate any efficacy benefits in comparison with tamoxifen in all patients as well as in the hormone receptor-positive population.
Kombinacija zdravila Arimidex in tamoksifena ni pokazala koristi glede učinkovitosti v primerjavi s tamoksifenom ne pri vseh bolnicah ne v populaciji s pozitivnimi hormonskimi receptorji.
Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing.
Anastrozol se pri ženskah po menopavzi izdatno presnovi in manj kot 10 % odmerka se nespremenjenega izloči v urinu v 72 urah po uporabi.
Dialysis may be helpful because Arimidex is not highly protein bound.
Dializa morda lahko koristi, ker zdravilo Arimidex ni v veliki meri vezano na beljakovine.
In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Pri ženskah po menopavzi nastaja estradiol predvsem s pretvorbo androstendiona v estron, ki poteka s kompleksom encima aromataze v perifernih tkivih.
There were no adverse effects on behaviour or reproductive performance of the first generation offspring attributable to maternal treatment with anastrozole.
V prvi generaciji potomstva ni bilo neželenih učinkov na vedenje ali reproduktivno sposobnost, ki bi jih bilo mogoče pripisati materinemu prejemanju anastrozola.
Study 1033IL/0027 showed that Arimidex and tamoxifen had similar objective tumour response rates and time to tumour progression.
Študija 1033IL/0027 je pokazala, da sta zdravilo Arimidex in tamoksifen dosegla podoben delež objektivnega odziva tumorja in časa do napredovanja tumorja.
However, some people may occasionally feel weak or sleepy while taking Arimidex.
A nekaterim osebam se med jemanjem zdravila Arimidex občasno lahko pojavi šibkost ali zaspanost.
If you stop taking Arimidex Do not stop taking your tablets unless your doctor tells you to.
Če ste prenehali jemati zdravilo Arimidex Ne nehajte jemati teh tablet, če vam tega ne naroči zdravnik.
• Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
• bolnicah z znano preobčutljivostjo za anastrozol ali katerokoli pomožno snov v zdravilu (pomožne snovi so navedene v poglavju 6.1).
• Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing.
• alergijske (preobčutljivostne) reakcije z otekanjem žrela, ki lahko povzroči težave s požiranjem ali dihanjem.
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.
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.
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.
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.
• Raised or high levels of a fatty substance known as cholesterol in your blood.
• zvišanje koncentracije maščobe, imenovane holesterol, v krvi.
• Pregnant or breast-feeding women.
• nosečnicah in doječih ženskah.
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.
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.
In both studies there were no significant differences between treatment arms with respect to any of the efficacy parameters.
V nobeni študiji ni bilo značilnih razlik med terapevtskima krakoma, kar zadeva katerikoli parameter učinkovitosti.
Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Cimetidin, ki je šibek in nespecifičen zaviralec encimov CYP, ni vplival na koncentracijo anastrozola v plazmi.
The primary endpoints for both trials were time to tumour progression, objective tumour response rate, and safety.
V obeh preskušanjih so bili primarni opazovani dogodki čas do napredovanja tumorja, objektivni delež odziva tumorja in varnost.
- It does not matter if you take Arimidex before, with or after food.
- Ni pomembno, ali zdravilo Arimidex vzamete pred jedjo, med jedjo ali po jedi.
Do not take Arimidex if any of the above apply to you.
Ne vzemite zdravila Arimidex, če kaj od naštetega velja za vas.
p-value Time to distant recurrenced
vrednost p Čas do oddaljene ponovitved
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).
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).
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.
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.
Myocardial infarct
Miokardni infarkt
In animal studies, anastrozole demonstrated low acute toxicity.
V študijah na živalih je bila akutna toksičnost anastrozola majhna.
Effects on your bones
Učinki na kosti
Like all medicines, Arimidex can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Arimidex neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
A total of 1,021 patients were randomised to receive 1 mg of Arimidex once daily or 20 mg of tamoxifen once daily.
Skupaj 1.021 bolnic so randomizirali na zdravljenje z 1 mg zdravila Arimidex enkrat na dan ali 20 mg tamoksifena enkrat na dan.
The most frequently reported adverse reactions were headache, hot flushes, nausea, rash, arthralgia, joint stiffness, arthritis, and asthenia.
Najpogosteje opisani neželeni učinki so bili glavobol, valovi vročine, navzea, izpuščaj, artralgija, togost sklepov, artritis in astenija.
• Inflammation of the small blood vessels causing red or purple colouring of the skin.
• vnetje drobnih žil, ki povzroči rdeče ali škrlatno obarvanje kože.
Fractures of the spine, hip, or wrist/Colles Wrist/Colles fractures
Zlomi hrbtenice, kolka ali zapestja/Collesovi zlomi Zlomi zapestja/Collesovi zlomi Zlomi hrbtenice
Each film-coated tablet contains 1 mg of anastrozole.
Ena filmsko obložena tableta vsebuje 1 mg anastrozola.
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).
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).
- 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 omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
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).
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).
Table 2 ATAC study pre-specified adverse events Adverse events
Preglednica 2 Vnaprej opredeljeni neželeni učinki v študiji ATAC Neželeni učinki
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).
Zdravila Arimidex ni priporočljivo uporabljati pri otrocih in mladostnikih, ker njegova varnost in učinkovitost v tej skupini bolnikov nista ugotovljeni (glejte poglavje 5.1).
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.
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.
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.
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.
Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer.
Zmanjšanje koncentracije estradiola v obtoku ima pri ženskah z rakom dojke dokazano ugoden vpliv.
There were no clinically significant interactions with bisphosphonates (see section 5.1).
Klinično pomembnih medsebojnih delovanj z difosfonati ni bilo (glejte poglavje 5.1).
• Changes in blood tests that show how well your liver is working.
• spremembe izvidov preiskav krvi, ki kažejo delovanje jeter
A single dose of Arimidex that results in life-threatening symptoms has not been established.
Posamičen odmerek zdravila Arimidex, ki bi povzročil življensko nevarne simptome, ni ugotovljen.
In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.
V študiji akutne peroralne toksičnosti na psih je bil mediani smrtni odmerek večji od 45 mg/kg/dan.
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).
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]).
Gynaecomastia studies
Študije ginekomastije
In animal studies adverse effects were only seen at high doses.
V študijah na živalih so neželene učinke opažali le pri velikih odmerkih.
Arimidex is not indicated for use in children and adolescents.
Zdravilo Arimidex ni indicirano za uporabo pri otrocih in mladostnikih.
If you forget to take Arimidex
Če ste pozabili vzeti zdravilo Arimidex
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.
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.
Arimidex is indicated for the:
Zdravilo Arimidex je indicirano za:
- The active substance is anastrozole.
- Zdravilna učinkovina je anastrozol.
What Arimidex looks like and contents of the pack
Izgled zdravila Arimidex in vsebina pakiranja
These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant to the treatment of patients with anastrozole.
Te spremembe veljajo za učinke zavrtja aromataze, ki so specifični za miši, in ne veljajo za klinično pomembne pri zdravljenju bolnikov z anastrozolom.
Before treatment with Arimidex check with your doctor or pharmacist - if you still have menstrual periods and have not yet gone through the menopause.
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.
• Trigger finger (a condition in which your finger or thumb catches in a bent position).
• sprožilni prst (motnja, pri kateri se kateri od prstov na roki zaskoči v upognjenem položaju)
Do not take Arimidex - if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Arimidex (see section 6: Further information).
Ne jemljite zdravila Arimidex - če ste alergični (preobčutljivi) na anastrozol ali katerokoli sestavino zdravila Arimidex (glejte poglavje
Vomiting may be induced if the patient is alert.
Če je bolnik priseben, se lahko izzove bruhanje.
Genetic toxicology studies with anastrozole show that it is not a mutagen or a clastogen.
Študije genotoksičnosti anastrozola kažejo, da ni mutagen ali klastogen.
Arimidex does not possess any progestogenic, androgenic, or estrogenic activity.
Zdravilo Arimidex ne deluje progestagensko, androgensko ali estrogensko.
Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation.
Presnova anastrozola poteka z N-dealkilacijo, hidroksilacijo in glukuronidacijo.
Very common Arthralgia/joint stiffness Arthritis
Zelo pogosti artralgija/togost sklepov artritis osteoporoza
- if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Taking other medicines').
- če jemljete kakšno zdravilo, ki vsebuje tamoksifen, ali zdravila, ki vsebujejo estrogene (glejte poglavje
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Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Zdravila Arimidex se ne sme uporabljati pri dečkih s pomanjkanjem rastnega hormona poleg zdravljenja z rastnim hormonom.
Table 1 Adverse reactions by System Organ Class and frequency Adverse reactions by SOC and frequency Metabolism and nutrition disorders Common
Preglednica 1 Neželeni učinki po organskih sistemih in pogostnosti Neželeni učinki po organskih sistemih in pogostnosti Presnovne in prehranske motnje
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).
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).
The observed fracture rate for Arimidex is similar to the range reported in age-matched postmenopausal populations.
Z zdravilom Arimidex opaženi delež zlomov je podoben razponu, opisanemu za starostno usklajene populacije po menopavzi.
Distant disease-free survival is defined as the first occurrence of distant recurrence or death (for any reason).
Preživetje brez oddaljene bolezni je opredeljeno kot prvi pojav oddaljene ponovitve ali smrti (zaradi kateregakoli vzroka).
Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Anastrozol zmanjša koncentracijo estradiola, zato se zdravila Arimidex ne sme uporabljati pri deklicah s pomanjkanjem rastnega hormona poleg zdravljenja z rastnim hormonom.
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.
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.
Mood disturbances
Motnje razpoloženja
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.
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.
Arimidex is used to treat breast cancer in women who have gone through the menopause.
Zdravilo Arimidex se uporablja za zdravljenje raka dojke pri ženskah, ki so že imele menopavzo.
Arimidex is contraindicated during pregnancy (see section 4.3).
Zdravilo Arimidex je med nosečnostjo kontraindicirano (glejte poglavje 4.3).
[See Annex I - To be completed nationally] This leaflet was last approved in {MM/YYYY}.
[Glejte Dodatek I - izpolni država članica] Navodilo je bilo odobreno {MM/LLLL}.
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.
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.
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.
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.
No statistically significant change in the rate of increase in bone age on treatment compared to the rate during baseline was observed.
Opazili niso nobene statistično značilne spremembe v hitrosti povečanja kostne starosti med zdravljenjem v primerjavi z izhodiščno hitrostjo.
However, plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
Toda koncentracija anastrozola v plazmi je bila pri prostovoljcih s cirozo jeter znotraj območja koncentracij, zabeleženih pri normalnih preiskovancih v drugih preskušanjih.
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.
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.
In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
V študiji plodnosti so nedavno odstavljenim podganjim samcem 10 tednov peroralno dajali 50 ali 400 mg/l anastrozola v pitni vodi.
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.
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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Arimidex.
Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Arimidex.
How to store Arimidex Further information
Shranjevanje zdravila Arimidex Dodatne informacije