natgillin/translations-raw huggingface dataset:
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).
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).
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).
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).
• Bone loss (osteoporosis).
• redčenje kosti (osteoporoza)
There are no data from the use of Arimidex in pregnant women.
Podatkov o uporabi zdravila Arimidex pri nosečnicah ni.
• Rare inflammation of your skin that may include red patches or blisters.
• redko vnetje kože, ki lahko obsega rdeče lise ali mehurje
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).
Zdravila Arimidex zaradi nezadostnih podatkov o varnosti in učinkovitosti ni priporočljivo uporabljati pri otrocih in mladostnikih (glejte poglavji 4.4 in 5.1).
Advanced breast cancer
Napredovali rak dojke
Time to distant recurrence is defined as the first occurrence of distant recurrence or death due to breast cancer.
Čas do oddaljene ponovitve je opredeljen kot prvi pojav oddaljene ponovitve ali smrti zaradi raka dojke.
Arimidex is not likely to affect your ability to drive or use any tools or machines.
Ni verjetno, da bi zdravilo Arimidex vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
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.
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.
The 12-month main analysis has shown that patients already at moderate to high risk of fragility fracture showed no decrease in their bone mass density (assessed by lumbar spine bone mineral density using DEXA scanning) when managed by using Arimidex 1 mg/day in combination with risedronate 35 mg once a week.
Glavna analiza po 12 mesecih je pokazala, da se bolnicam z zmernim do velikim tveganjem za zlome zaradi krhkosti gostota kosti (ocenjena z mineralno gostoto kosti v ledveni hrbtenici s slikanjem DEXA) ni zmanjšala, če so bile zdravljenje z zdravilom Arimidex 1 mg/dan v kombinaciji z risedronatom 35 mg enkrat na teden.
No statistically significant change in the frequency of vaginal bleeding days on treatment was observed.
Med zdravljenjem niso opazili statistično značilne razlike v pogostnosti dni nožnične krvavitve.
• Inflammation of the liver (hepatitis).
• vnetje jeter (hepatitis)
Second-line therapy in postmenopausal women with advanced breast cancer Arimidex was studied in two controlled clinical trials (Study 0004 and Study 0005) in postmenopausal women with advanced breast cancer who had disease progression following tamoxifen therapy for either advanced or early breast cancer.
Zdravljenje druge linije pri ženskah z napredovalim rakom dojke Zdravilo Arimidex so raziskali v dveh kontroliranih kliničnih preskušanjih (študija 0004 in študija 0005) pri ženskah po menopavzi z napredovalim rakom dojke, ki jim je bolezen po zdravljenju s tamoksifenom (bodisi zaradi napredovalega ali zgodnjega raka dojke) napredovala.
The primary efficacy parameter was the analysis of lumbar spine bone mass density using DEXA scanning.
Primarni parameter učinkovitosti je bila analiza gostote kosti v ledveni hrbtenici s slikanjem DEXA.
AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom
AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA Velika Britanija
Keep taking Arimidex for as long as your doctor tells you to.
Zdravilo Arimidex jemljite toliko časa, kot vam naroči zdravnik.
* Events of Carpal Tunnel Syndrome have been reported in patients receiving Arimidex treatment in clinical trials in greater numbers than those receiving treatment with tamoxifen.
* Med osebami, ki so v kliničnih preskušanjih prejemale zdravilo Arimidex, so bili primeri sindroma karpalnega kanala opisani v večjem številu kot med osebami, zdravljenimi s tamoksifenom.
In a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (see below), Arimidex was shown to be statistically superior to tamoxifen in disease-free survival.
Velika študija III. faze 9.366 žensk po menopavzi, ki so imele operabilnega raka dojke in so bile zdravljene pet let (glejte spodaj), je pokazala, da je bilo zdravilo Arimidex glede preživetja brez bolezni statistično boljše od tamoksifena.
Somnolence Carpal Tunnel Syndrome*
Pogosti zaspanost sindrom karpalnega kanala*
Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day.
Peroralna uporaba anastrozola pri podganjih samicah je povzročila veliko incidenco neplodnosti pri odmerku 1 mg/kg/dan in večje predimplantacijske izgube pri 0,02 mg/kg/dan.
Disease-free survival includes all recurrence events and is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death (for any reason).
Preživetje brez bolezni vključuje vse ponovitvene dogodke in je opredeljeno kot prvi pojav lokoregionalne ponovitve, novega raka dojke na nasprotni dojki, oddaljene ponovitve ali smrti (zaradi kateregakoli vzroka).
If you are not sure, talk to your doctor or pharmacist before taking Arimidex.
Če ste negotovi, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete zdravilo Arimidex.
A two-year rat oncogenicity study resulted in an increase in incidence of hepatic neoplasms and uterine stromal polyps in females and thyroid adenomas in males at the high dose (25 mg/kg/day) only.
Dveletna študija onkogenosti na podganah je povzročila povečanje incidence jetrnih novotvorb in materničnih stromalnih polipov pri samicah ter ščitničnih adenomov pri samcih le pri velikih odmerkih (25 mg/kg/dan).
Very common Hot flushes Very common Nausea
Zelo pogosti valovi vročine
In acute toxicity studies in rodents, the median lethal dose of anastrozole was greater than 100 mg/kg/day by the oral route and greater than 50 mg/kg/day by the intraperitoneal route.
V študijah akutne toksičnosti na glodalcih je bil mediani smrtni odmerek anastrozola po peroralni uporabi več kot 100 mg/kg/dan in po intraperitonealni uporabi več kot 50 mg/kg/dan.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction for the indicated population.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka za indicirano populacijo.
[See Annex I - To be completed nationally]
[Glejte Dodatek I - izpolni država članica]
Increases in gamma-GT and bilirubin Hepatitis Very common Rash Common
Občasni zvišanje gama-GT in bilirubina hepatitis
Anastrozole pharmacokinetics are independent of age in postmenopausal women.
Farmakokinetika anastrozola pri ženskah po menopavzi ni odvisna od starosti.
A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11 to 16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Randomizirana dvojno slepa multicentrična študija je ocenila 52 pubertetnih dečkov (starih od 11 do vključno 16 let), ki so od 12 do 36 mesecev prejemali 1 mg zdravila Arimidex na dan ali placebo v kombinaciji z rastnim hormonom.
• Inflammation of the joints (arthritis).
• vnetje sklepov (artritis)
These findings were mirrored in the secondary efficacy variable of change from baseline in total hip BMD at 12 months.
Ti izsledki so se odrazili na sekundarni spremenljivki učinkovitosti, spremembi celotne mineralne gostote kosti v kolku po 12 mesecih v primerjavi z izhodiščem.
Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
Zdravilo Arimidex ni raziskano pri bolnicah z rakom dojke in zmerno ali hudo okvaro jeter.
Time to recurrence is defined as the first occurrence of loco-regional recurrence, contralateral new breast cancer, distant recurrence or death due to breast cancer.
Čas do ponovitve je opredeljen kot prvi pojav lokoregionalne ponovitve, novega raka dojke na nasprotni dojki, oddaljene ponovitve ali smrti zaradi raka dojke.
In animal studies toxicity was only seen at high doses.
V študijah na živalih so toksične učinke opažali samo pri velikih odmerkih.
If this happens to you, ask your doctor or pharmacist for advice.
Če se vam to zgodi, za nasvet prosite zdravnika ali farmacevta.
If this applies to you, ask your doctor or pharmacist for advice.
Če to velja za vas, za nasvet prosite zdravnika ali farmacevta.
0.31 to 0.88
0,31 do 0,88
As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8).
Zdravilo Arimidex zmanjša koncentracijo estrogena v obtoku, zato lahko zmanjša mineralno gostoto kosti in tako poveča tveganje zlomov (glejte poglavje 4.8).
Oral administration of anastrozole to pregnant rats and rabbits caused no teratogenic effects at doses up to 1.0 and 0.2 mg/kg/day respectively.
Peroralno dajanje anastrozola brejim podganam in kunkam ni povzročilo teratogenih učinkov v odmerkih do 1,0 mg/kg/dan (podgane) oz. do 0,2 mg/kg/dan (kunke).
0.63 to 1.46
0,63 do 1,46
Arimidex should not be used in premenopausal women.
Zdravila Arimidex se ne sme uporabljati pri ženskah pred menopavzo.
0.19 to 1.13
0,19 do 1,13
There is no evidence of time or dose-dependency of anastrozole pharmacokinetic parameters.
Ni znakov, da bi bili farmakokinetični parametri anastrozola odvisni od časa ali odmerka.
Coronary artery disorder
Bolezen koronarnih arterij
Number of events (frequency) Intention-to-treat population Hormone receptor-positive tumour status
Število dogodkov (pogostnost) Populacija z-namenomzdravljenja
There were no clinically significant changes in Tanner staging, mean ovarian volume, or mean uterine volume.
Ugotovili niso nobenih klinično pomembnih razlik v razvrstitvi po Tannerju, povprečnem volumnu jajčnikov in povprečnem volumnu maternice.
0.49 to 0.92
0,49 do 0,92
Tamoxifen (N=1,282)
Tamoksifen (n = 1.282)
0.85 to 1.12
0,85 do 1,12
Arimidex lowers the amount of the hormone called estrogen that is in your body.
Zdravilo Arimidex zmanjša količino hormona estrogena v telesu.
Arimidex has not been investigated in breast cancer patients with severe renal impairment.
Zdravilo Arimidex ni raziskano pri bolnicah z rakom dojke in hudo okvaro ledvic.
Tamoxifen (N=3,116)
Tamoksifen (n = 3.116)
Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).
Sočasni uporabi tamoksifena in zdravil, ki vsebujejo estrogene z zdravilom Arimidex se je potrebno izogibati, saj lahko zmanjša njegovo farmakološko delovanje (glejte poglavji 4.5 in 5.1).
0.35 to 0.79
0,35 do 0,79
Trial 0006 was a randomised, double-blind, multi-centre study of 82 pubertal boys (aged 11-18 years inclusive) with gynaecomastia of greater than 12 months duration treated with Arimidex 1 mg/day or placebo daily for up to 6 months.
Preskušanje 0006 je bilo randomizirana dvojno slepa multicentrična študija 82 pubertetnih dečkov (starih od 11 do vključno 18 let) z več kot 12 mesecev trajajočo ginekomastijo, ki so do 6 mesecev dobivali 1 mg zdravila Arimidex na dan ali placebo vsak dan.
Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.4 and 5.1).
Sočasni uporabi tamoksifena in zdravil, ki vsebujejo estrogene z zdravilom Arimidex se je potrebno izogibati, saj lahko zmanjša njegovo farmakološko delovanje (glejte poglavji 4.4 in 5.1).
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Adjuvantno zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi, ki so 2 do 3 leta dobivale adjuvantni tamoksifen.
Exposure to anastrozole can be increased in subjects with hepatic impairment (see section 5.2); administration of Arimidex in patients with moderate and severe hepatic impairment should be performed with caution (see section 4.2).
Izpostavljenost anastrozolu je lahko pri osebah z okvaro jeter večja (glejte poglavje 5.2); pri bolnicah z zmerno in hudo okvaro jeter je treba zdravilo Arimidex uporabljati previdno (glejte poglavje 4.2).
In postmenopausal women, Arimidex at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay.
Pri ženskah po menopavzi je uporaba dnevnega odmerka 1 mg zdravila Arimidex po meritvi z zelo občutljivim preskusom zavrla nastajanje estradiola za več kot
0.80 to 1.07
0,80 do 1,07
- The other ingredients are: lactose monohydrate, povidone, sodium starch glycollate, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.
- Pomožne snovi so: laktoza monohidrat, povidon, natrijev karboksimetilškrob, magnezijev stearat,
Tamoxifen (N=2,598)
Tamoksifen (n = 2.598)
• Pain or stiffness in your joints.
• bolečine v sklepih ali togost sklepov
0.64 to 0.87
0,64 do 0,87
Arimidex is contraindicated during breast-feeding (see section 4.3).
Zdravilo Arimidex je med obdobjem dojenja kontraindicirano (glejte poglavje 4.3).
Plasma anastrozole concentrations observed during longterm efficacy trials in patients with renal impairment were within the range of plasma anastrozole concentrations seen in patients without renal impairment.
Koncentracija anastrozola v plazmi, zabeležena med dolgotrajnimi preskušanji učinkovitosti pri bolnikih z okvaro ledvic je bila v območju koncentracij anastrozola v plazmi, zabeleženih pri bolnikih brez okvare ledvic.
Plasma anastrozole concentrations observed during long-term efficacy trials in patients with hepatic impairment were within the range of plasma anastrozole concentrations seen in patients without hepatic impairment.
Koncentracija anastrozola v plazmi, zabeležena med dolgotrajnimi preskušanji učinkovitosti pri bolnikih z okvaro jeter je bila v območju koncentracij anastrozola v plazmi, zabeleženih pri bolnikih brez okvare jeter.
HOW TO TAKE ARIMIDEX
KAKO JEMATI ZDRAVILO ARIMIDEX
In addition, a decrease in BMD which was not statistically significant was seen in the low risk group treated with Arimidex 1 mg/day alone.
Poleg tega je bilo v skupini z majhnim tveganjem, ki je dobivala samo zdravilo Arimidex 1 mg/dan, opazno zmanjšanje mineralne gostote kosti, ki pa ni bilo statistično značilno.
Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.
Klinične študije z antipirinom in varfarinom so pokazale, da anastrozol v odmerku 1 mg ni bistveno zavrl presnove antipirina ali R- in S-varfarina.
0.70 to 0.90
0,70 do 0,90
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2 and 4.4).
Pri bolnikih s hudo okvaro ledvic je treba zdravilo Arimidex uporabljati previdno (glejte poglavji 4.2 in 4.4).
Tamoxifen (N=3,094)
Tamoksifen (n = 3.094)
Pharmacotherapeutic group: Enzyme inhibitors, ATC code: L02B G03
Oznaka ATC: L02BG03
Very rare side effects (affect less than 1 person in 10,000 people)
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10.000 bolnikov)
Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients
Adjuvantno zdravljenje zgodnjega invazivnega raka dojke pri bolnicah pozitivnimi hormonskimi receptorji
What Arimidex contains
Kaj vsebuje zdravilo Arimidex
A total of 764 patients were randomised to receive either a single daily dose of 1 mg or 10 mg of Arimidex or megestrol acetate 40 mg four times a day.
Skupaj 764 bolnic so randomizirali bodisi na enkratni dnevni odmerek 1 mg ali 10 mg zdravila Arimidex ali na 40 mg megestrolacetata štirikrat na dan. Primarni spremenljivki učinkovitosti sta bili čas do napredovanja in objektivni delež odziva.
For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.
Priporočeno trajanje adjuvantnega endokrinega zdravljenja žensk po menopavzi z zgodnjim invazivnim rakom dojke in pozitivnimi hormonskimi receptorji je 5 let.
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.4 and 5.2).
Pri bolnicah s hudo okvaro ledvic je treba zdravilo Arimidex uporabljati previdno (glejte poglavji 4.4 in 5.2).
p-value Time to recurrencec
vrednost p Čas do ponovitvec
Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Pri bolnikih z zmerno do hudo okvaro jeter je priporočljiva previdnost (glejte poglavje 4.4).
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET [Izpolni država članica]
Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients being treated with adjuvant tamoxifen
Adjuvantno zdravljenje zgodnjega invazivnega raka dojke pri bolnicah s pozitivnimi hormonskimi receptorji, zdravljenih z adjuvantnim tamoksifenom
0.78 to 0.97
0,78 do 0,97
Fatigue/asthenia
Utrujenost/astenija
This study provides evidence that the use of bisphosphonates could be considered in the management of possible bone mineral loss in postmenopausal women with early breast cancer scheduled to be treated with Arimidex.
Ta študija dokazuje, da pride pri ženskah po menopavzi, ki imajo zaradi zgodnjega raka dojke predvideno zdravljenje z zdravilom Arimidex, v poštev uporaba difosfonatov za obvladanje morebitnega zmanjšanja mineralne gostote kosti.
NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets
IME ZDRAVILA Arimidex in z njim povezana imena (glejte Dodatek I) 1 mg filmsko obložene tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 1 mg anastrozola.
0.83 to 1.14
0,83 do 1,14
This is because these medicines may stop Arimidex from working properly.
Ta zdravila namreč lahko preprečijo pravilno delovanje zdravila
A greater magnitude of benefit was observed for disease free survival in favour of Arimidex versus tamoxifen for the prospectively defined hormone receptor-positive population.
V prospektivno opredeljeni populaciji s pozitivnimi hormonskimi receptorji so z zdravilom Arimidex ugotovili večjo korist glede preživetja brez bolezni kot s tamoksifenom.
Diarrhoea Vomiting
Žilne bolezni
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - izpolni država članica]
0.83 to 1.06
0,83 do 1,06
Fracture rates of 22 per 1,000 patient-years and 15 per 1,000 patient-years were observed for the Arimidex and tamoxifen groups, respectively, after a median follow-up of 68 months.
Po mediano 68-mesečnem spremljanju je bil delež zlomov v skupini z zdravilom Arimidex 22 na 1.000 bolnic-let in v skupini s tamoksifenom 15 na 1.000 bolnic-let.
0.39 to 0.89
0,39 do 0,89
Batch release sites
Mesta sproščanja serij
Arimidex works by cutting down the amount of the hormone called estrogen that your body makes.
Zdravilo Arimidex deluje tako, da zmanjša nastajanje hormona estrogena v telesu.
Vaginal dryness Vaginal bleeding ***
Pogosti suhost nožnice krvavitev iz nožnice ***
0.74 to 0.99
0,74 do 0,99
Very common side effects (affect more than 1 in 10 people)
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov)
Uncommon side effects (affect 1 to 10 people in 1,000)
Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1.000 bolnikov)
Time to any recurrence Hazard ratio 2-sided 95% CI
Čas do oddaljene ponovitve Razmerje ogroženosti 2-stranski 95 % IZ
0.73 to 0.94
0,73 do 0,94
• Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
• Zdravljenje napredovalega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
No significant difference in the number of patients who had a 50% or greater reduction in total breast volume after 6 months of treatment was observed between the Arimidex 1 mg treated group and the placebo group.
Med skupino, zdravljeno z 1 mg zdravila Arimidex, in skupino, ki je dobivala placebo, niso ugotovili značilne razlike v številu bolnikov, ki se jim je po 6 mesecih zdravljenja volumen dojk zmanjšal za 50 % ali več.
First-line therapy in postmenopausal women with advanced breast cancer Two double-blind, controlled clinical studies of similar design (Study 1033IL/0030 and Study 1033IL/0027) were conducted to assess the efficacy of Arimidex compared with tamoxifen as first-line therapy for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women.
Zdravljenje prve linije pri ženskah z napredovalim rakom dojke Za oceno učinkovitosti zdravila Arimidex v primerjavi s tamoksifenom kot zdravljenjem prve linije pri ženskah po menopavzi, ki so imele raka dojke s pozitivnimi hormonskimi receptorji ali lokalno napredovalega ali metastatskega raka dojke z neznanim stanjem hormonskih receptorjev, sta bili opravljeni dve dvojno slepi, kontrolirani klinični študiji s podobnim načrtom (študija 1033IL/0030 in študija 1033IL/0027).
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women.
• Adjuvantno zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
The enzymes mediating metabolism of anastrozole have not been identified.
Encimi, s katerimi se presnovi anastrozol, niso ugotovljeni.
• Thinning of your hair (hair loss).
• razredčenje las (izpadanje las)
Hazard ratio 2-sided 95% CI
Razmerje ogroženosti 2-stranski 95 % IZ
No dose change is recommended in patients with mild or moderate renal impairment.
Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba spremeniti.
The primary endpoint was change from baseline in lumbar spine bone mass density at 12 months.
Primarni opazovani dogodek je bila sprememba gostote kosti v ledveni hrbtenici po 12 mesecih v primerjavi z izhodiščem.
Rare side effects (affect 1 to 10 people in 10,000)
Redki neželeni učinki (pojavijo se pri 1 do 10 od 10.000 bolnikov)
• Diarrhoea.
• zaspanost
Very common Asthenia
Zelo pogosti glavobol
New contralateral breast cancer Odds ratio
Nov kontralateralni rak dojke Razmerje obetov 2-stranski 95 % IZ
Overall survival Hazard ratio 2-sided 95% CI
Celotno preživetje Razmerje ogroženosti 2-stranski 95 % IZ
Trigger finger
Občasni sprožilni prst
0.30 to 0.76
0,30 do 0,76
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - izpolni država članica]
• Hives or nettle rash.
• koprivke ali koprivnica
Hot flushes
Valovi vročine
HOW TO STORE ARIMIDEX
SHRANJEVANJE ZDRAVILA ARIMIDEX
There are no data on the use of Arimidex during lactation.
O uporabi zdravila Arimidex med obdobjem dojenja ni podatkov.