natgillin/translations-raw huggingface dataset:
Given that cimetidine is currently known to be a weak, unspecific cytochrome P450 inhibitor, it was considered more relevant to include reference to existing data on warfarin.
Glede na to, da je cimetidin trenutno znan kot šibek, nespecifičen zaviralec citokroma P450, se je štelo, da je pomembneje vključiti sklic na obstoječe podatke o varfarinu.
The drug product specification complies with all relevant guidelines and standards.
Specifikacija za zdravilo je v skladu z vsemi zadevnimi smernicami in standardi.
Harmonised versions of the labelling and of the package leaflet were adopted.
Sprejete so bile usklajene različice za označevanje in navodilo za uporabo.
Section 4.7 Effects on ability to drive and use machines There were no significant differences between the SPC of different countries for this section.
Poglavje 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji V tem poglavju ni bilo bistvenih razlik med povzetki glavnih značilnosti zdravila različnih držav.
The CHMP requested for this statement to be deleted as it is contradictory with the inclusion of hypercholesterolaemia as a common adverse event in section 4.8.
CHMP je zahteval, da se ta izjava izbriše, saj nasprotuje vključitvi hiperholesterolemije kot pogostega neželenega učinka v poglavje 4.8.
The final adopted wording on use in renal and hepatic impairment is as follows:
Končno potrjeno besedilo glede uporabe pri okvari ledvic in jeter je:
The MAH also proposed to include a summary of the paediatric studies on gynaecomastia and McCune-Albright syndrome, which had already been approved in a number of countries.
Imetnik dovoljenja za promet z zdravilom je predlagal tudi vključitev povzetka pediatričnih študij o ginekomastiji in McCune-Albrightovem sindromu, kar je bilo v več državah že odobreno.
In a small number of countries the indication includes reference to the reduction in incidence of contra lateral breast cancer, based on a secondary endpoint of the previously mentioned ATAC study.
V nekaterih državah so indikacije vključevale tudi sklicevanje na zmanjšano pogostnost pojavljanja kontralateralnega raka dojke, in sicer na podlagi sekundarnega cilja zgoraj omenjene študije ATAC.
However, CHMP considered that this could be misinterpreted as implying an effect in hormone receptor negative patients, when in fact it merely reflects the inclusion criteria of clinical studies.
Vendar je CHMP menil, da se lahko to napačno razlaga, kot da učinkuje na bolnice, negativne na hormonske receptorje, pri čemer dejansko le odraža vključitvena merila za klinične študije.
The inclusion of the term ‘invasive' is supported by data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) study in which 9366 patients were evaluated from 381 centres worldwide (3125 randomised to anastrozole 1 mg alone, 3116 randomised to tamoxifen 20 mg alone and 3125 randomised to anastrozole plus tamoxifen).
Vključitev izraza „invazivni“ podpirajo tudi podatki iz študije ATAC (Zdravljenje z zdraviloma Arimidex in Tamoxifen, samostojno ali v kombinaciji), v kateri so ocenjevali 9 366 bolnic iz 381 centrov iz celega sveta (3 125 randomizirano razvrščenih na monoterapijo z 1 mg anastrozola, 3 116 randomizirano razvrščenih na monoterapijo z 20 mg tamoksifena in 3 125 randomizirano razvrščenih na anastrozol skupaj s tamoksifenom).
This product contains lactose.
Zdravilo vsebuje laktozo.
Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Cimetidin, šibek in nespecifičen zaviralec encimov CYP, ni vplival na plazemske koncentracije anastrozola.
A reference to reduction in incidence of contra lateral breast cancer would not add to the patient population and should therefore be included only in section 5.1 of the SPC.
Sklicevanje na manjšo pojavnost kontralateralnega raka dojke ne bi razširilo populacije bolnikov in se zato vključi le v poglavje 5.1 povzetka glavnih značilnosti zdravila.
Information on severe renal impairment and moderate or severe hepatic impairment was also moved to section 4.4, as based on the latest studies a significant increase in exposure is not expected with renal impairment, and only a modest increase in exposure was observed in patients with hepatic impairment.
Podatki o hudih okvarah ledvic in zmerni ali hudi okvari jeter so bili prav tako prestavljeni v poglavje 4.4, saj so zadnje študije pokazale, da pri okvari ledvic ni pričakovati pomembnega povečanja izpostavljenosti, pri bolnikih z okvaro jeter pa je bilo opaženo le majhno povečanje izpostavljenosti.
Section 4.4 Special warnings and precautions for use
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi
Section 4.1 Therapeutic indications
Poglavje 4.1 Terapevtske indikacije
Section 5.3 Preclinical safety data
Poglavje 5.3 Predklinični podatki o varnosti
The proposed indication is supported by a phase III trial (Austrian Breast and Colorectal Cancer Study Group [ABCSG] 8) conducted in postmenopausal women with hormone receptor positive early breast cancer.
Predlagano indikacijo podpira preskušanje faze III ABSCG (Avstrijska študijska skupina 8 za raka dojke ter raka debelega črevesa in danke), ki so jo izvedli pri ženskah po menopavzi z zgodnjim rakom dojke, pozitivnim na hormonske receptorje.
Summary of Product Characteristics
Povzetek glavnih značilnosti zdravila
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
The CHMP noted the MAH's proposal for section 4.4 and agreed with the majority of the content.
CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom za poglavje 4.4 in se strinjal z večino vsebine.
Therefore, the CHMP concluded that the lack of data in moderate to severe hepatic impairment should be highlighted, but that considering the fact that the product is a potentially life-saving treatment, a warning rather than a contraindication was appropriate.
CHMP je tako sklenil, da je treba izpostaviti nezadostnost podatkov pri zmernih do hudih okvarah jeter, vendar pa je ob upoštevanju dejstva, da lahko zdravljenje s tem zdravilom morda reši življenje, opozorilo primernejše kot kontraindikacija.
The active substance specification complies with all relevant guidelines and standards.
Specifikacija za zdravilno učinkovino je v skladu z vsemi zadevnimi smernicami in standardi.
Section 4.3 Contraindications
Poglavje 4. 3 Kontraindikacije
The CHMP noted that the MAH did not suggest its inclusion as part of the harmonised indication, and agreed to this.
CHMP je izpostavil, da imetnik dovoljenja za promet z zdravilom ni predlagal vključitve tega dela v usklajene indikacije in se s tem strinjal.
The drug product specification has been harmonised and includes the following tests: description, average weight, identity, dissolution, content, uniformity of content, water content, degradation products, identification of titanium dioxide and microbial quality.
Specifikacija za zdravilo je bila usklajena in vključuje naslednje preskuse: opis, povprečna masa, opredelitev, raztapljanje, vsebnost, enotnost vsebine, vsebnost vode, razgradni produkti, identifikacija titanovega dioksida in mikrobna kakovost.
The CHMP noted the proposal from the MAH and asked for a revision of the wording on the pharmacokinetics on the paediatric population, to clarify the exact characteristics of the population studied and its potential impact on the results obtained.
CHMP je preučil predlog imetnika dovoljenja za promet z zdravilom in zaprosil za revizijo besedila v zvezi s farmakokinetiko pri pediatrični populaciji, da bi se pojasnile natančne značilnosti preučevane populacije in njihov vpliv na pridobljene rezultate.
There are no data to support the use of Arimidex with LHRH analogues.
Podatkov v podporo uporabi zdravila Arimidex z analogi LHRH ni.
The effects of Arimidex on fertility in humans have not been studied.
Učinki zdravila Arimidex na plodnost pri ljudeh niso bili preučeni.
In order to harmonise the SPCs for Arimidex, the following therapeutic indications were agreed upon:
Za uskladitev povzetka glavnih značilnosti zdravila Arimidex so bile potrjene naslednje terapevtske indikacije:
Therefore the proposed warning on renal impairment was revised, at the request of the CHMP, to reflect that exposure to anastrozole is not increased in patients with severe renal impairment, but still in these patients administration should be performed with caution.
Predlagano opozorilo glede okvare ledvic je bilo zato na zahtevo CHMP spremenjeno tako, da odraža dejstvo, da se izpostavljenost anastrozolu pri bolnikih s hudo okvaro ledvic ne poveča, vendar je pri teh bolnikih vseeno potrebna previdnost pri uporabi.
Efficacy has not been demonstrated in estrogen receptor-negative patients unless they had a previous positive clinical response to tamoxifen.
Učinkovitost pri bolnicah, negativnih na estrogenske receptorje, ni bila dokazana, razen v primerih predhodnega pozitivnega kliničnega odziva na tamoksifen.
A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products.
Pregled podatkovne baze kliničnih preskušanj varnosti zdravila ni odkril dokazov o klinično pomembnih interakcijah pri bolnikih, ki so jih zdravili z zdravilom Arimidex in so hkrati jemali druga pogosto predpisana zdravila.
Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter.
Pri ženskah z osteoporozo ali tveganjem za osteoporozo je treba na začetku zdravljenja in nato v rednih presledkih s testiranjem preveriti mineralno gostoto kosti.
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 ali mladostnikih, ker pri tej skupini bolnikov varnost in učinkovitost zdravila nista bili dokazani (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 se izvajala z različnimi odmerki zdravila Arimidex, pri čemer je posamičen odmerek, ki ga je prejel odrasel zdrav moški prostovoljec, znašal do 60 mg, pri ženskah po menopavzi z napredovalim rakom dojke pa do 10 mg; te odmerke so dobro prenašali.
Arimidex (anastrozole) is a highly selective non-steroidal aromatase inhibitor.
Zdravilo Arimidex (anastrozol) je visoko selektiven in nesteroiden zaviralec aromataze.
In section 4.8, the MAH proposed to align the System Organ Class terms with the MedDRA dictionary, including the frequency groupings, harmonising several adverse reaction frequencies that varied between Member States, and updating the frequency of events such as Stevens-Johnson syndrome and angioedema from ‘not known' to ‘very rare', based on data from the ATAC study 5year analysis.
Imetnik dovoljenja za promet z zdravilom je za poglavje 4.8 predlagal uskladitev izrazov organskih sistemov v skladu s slovarjem MedDRA, vključno z opredelitvijo pogostnosti, uskladitvijo pogostnosti več neželenih učinkov, ki so se med posameznimi državami članicami razlikovale, ter posodobitvijo pogostnosti pojavljanja dogodkov, kot sta na primer Stevens-Johnsonov sindrom in angioedem, iz „neznano“ v „zelo redko“, na podlagi podatkov iz petletne analize študije ATAC.
The active substance specification has been harmonised and includes the following tests: description, identification, clarity of solution, sulphated ash, water content, strength, related substances, residual solvent, heavy metals, specific surface area and microscopy.
Specifikacija za zdravilno učinkovino je bila usklajena in vključuje naslednje preskuse: opis, opredelitev, bistrost raztopine, sulfatni pepel, vsebnost vode, jakost, sorodne snovi, ostanek vehikla, težke kovine, specifična površina in mikroskopija.
In addition, the Committee considered that the contraindication would be more appropriate for breastfeeding women rather than lactating women.
Odbor je prav tako menil, da je kontraindikacija primernejša pri ženskah, ki dojijo, kot pri ženskah v obdobju laktacije.
The majority of the European countries had identical wording included in this section.
V večini evropskih držav je bilo besedilo v tem poglavju enako.
The CHMP considered also that a summary of the safety profile needed to be included in the beginning of the section in accordance to the SPC guideline.
CHMP je prav tako menil, da je treba v skladu s smernico o povzetkih glavnih značilnosti zdravila na začetek poglavja vključiti tudi povzetek varnostnega profila.
As mentioned above, the wording of this paragraph may need to be revised in the future as a consequence of an ongoing procedure under Art. 45 of Regulation 1901/2006 as amended specifically to assess this set of paediatric data.
Kot je bilo navedeno, bo morda potreben popravek tega poglavja zaradi trenutno potekajočega postopka za ocenjevanje tega sklopa pediatričnih podatkov, ki poteka v skladu s členom 45 Uredbe 1901/2006, kakor je bila spremenjena.
In most countries the SPCs contained only a contraindication for the use of anastrazole in pregnancy and lactation with no additional information.
V povzetkih glavnih značilnosti zdravila večine držav članic je bila navedena le kontraindikacija za uporabo anastrozola v času nosečnosti in dojenja, brez dodatnih informacij.
Section 4.9 Overdose
Poglavje 4.9 Preveliko odmerjanje
Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
Po potrebi je treba začeti in pozorno spremljati zdravljenje ali preprečevanje osteoporoze.
The CHMP noted the proposal from the MAH to contraindicate use in pregnancy and lactation but considered that reference should be made to the lack of data in humans and a reference to reproductive toxicity in animals should be included.
CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom, da kontraindicira uporabo v nosečnosti in času dojenja ter menil, da je treba omeniti pomanjkanje podatkov pri ljudeh in vključiti navedbo o reproduktivni toksičnosti pri živalih.
Dialysis may be helpful because Arimidex is not highly protein bound.
Pomaga lahko tudi dializa, saj se zdravilo Arimidex ne veže v veliki meri na beljakovine.
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 posebnih zdravil, na primer bisfosfonatov, lahko zaustavi nadaljnjo izgubo mineralne gostote kosti, ki jo povzroča zdravilo Arimidex pri ženskah po menopavzi, in je treba razmisliti o njihovi uporabi (glejte poglavje 4.8).
Aromatase inhibitors have demonstrated efficacy in estrogen receptor positive patients, and has shown to have little efficacy in hormone receptor negative patients as could be anticipated by the mechanism of action.
Zaviralci aromataze so pokazali učinkovitost pri bolnicah, pozitivnih na estrogenske receptorje, in majhno učinkovitost pri bolnicah, negativnih na hormonske receptorje, kar je glede na mehanizem delovanja pričakovano.
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 odmerek 1 mg anastrozola ni pomembno zavrl presnavljanja antipirina ter R- in S-varfarina, kar kaže, da sočasna uporaba zdravila Arimidex z drugimi zdravili verjetno ne bo povzročila klinično pomembnega medsebojnega delovanja zdravil zaradi encimov CYP.
Section 5.2 Pharmacokinetic properties
Poglavje 5.2 Farmakokinetične lastnosti
In its initial proposal the MAH suggested the following wording: Treatment of advanced breast cancer in postmenopausal women.
V prvotnem predlogu je imetnik dovoljenja za promet z zdravilom predlagal naslednje besedilo: Zdravljenje žensk po menopavzi z napredovalim rakom dojke.
The Quality Modules of Arimidex Tablet Marketing Authorisation Application have been harmonised and updated from Notice to Applicant (NTA) format to Common Technical Document (CTD) format.
Moduli kakovosti za tablete zdravila Arimidex v vlogi za dovoljenje za promet so bili usklajeni in posodobljeni iz oblike navodil predlagateljem v obliko skupnega tehničnega dokumenta.
Since anastrozole reduces estradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Ker anastrozol znižuje raven estradiola, se zdravilo Arimidex ne sme uporabljati pri dekletih s pomanjkanjem rastnega hormona, ki se zdravijo z rastnim hormonom.
Patients who switched to Arimidex after 2 years of adjuvant treatment with tamoxifen had a significant improvement in disease free survival compared to patients who remained on tamoxifen.
Pri bolnikih, ki so po dveh letih dodatne terapije s tamoksifenom prešli na zdravljenje z zdravilom Arimidex, se je pokazalo pomembno izboljšanje preživetja brez bolezni v primerjavi z bolniki, ki so se še naprej zdravili s tamoksifenom.
In study 1033IL/0014, the apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis, although plasma anastrozole concentrations in the volunteers with hepatic cirrhosis were within the range of concentrations seen in normal subjects in other trials.
V študiji 1033IL/0014 je bil navidezni očitek (CL/F) anastrozola po peroralni uporabi pri prostovoljcih s stabilno cirozo jeter približno 30 %, čeprav so bile koncentracije anastrozola v plazmi pri prostovoljcih s cirozo jeter v mejah koncentracij, opaženih pri zdravih preiskovancih v drugih študijah.
The CHMP noted the wording suggested by the MAH for this section and proposed a few revisions.
CHMP je preučil predlagano besedilo imetnika dovoljenja za promet z zdravilom za to poglavje in predlagal nekaj popravkov.
There are no data from the use of Arimidex in pregnant women.
Podatkov o uporabi zdravila Arimidex pri nosečih ženskah ni.
Bone density decrease and Henoch-Schönlein purpura were added to section 4.8 as adverse events.
V poglavje 4.8 sta bila kot neželena učinka dodana zmanjšanje gostote kosti in Henoch-Schönleinova purpura.
Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer.
Zniževanje koncentracije estradiola, ki kroži v krvi, se je pri ženskah z rakom dojke izkazalo kot koristno.
The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status.
Menopavzo je treba pri vseh bolnicah, pri katerih obstaja dvom glede menopavze, določiti biokemično (luteinizirajoči hormon (LH), folikle stimulirajoči hormon (FSH) in/ali raven estradiola).
The CHMP adopted the following wording for this section:
CHMP je za to poglavje sprejel naslednje besedilo:
A single dose of Arimidex that results in life-threatening symptoms has not been established.
Posamični odmerek zdravila Arimidex, ki bi povzročil življenjsko nevarne simptome, ni bil ugotovljen.
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 pa so pri uporabi zdravila Arimidex poročali o asteniji in zaspanosti, zato je pri vožnji in upravljanju s stroji potrebna previdnost, če takšni simptomi ne izzvenijo.
There is limited clinical experience of accidental overdose.
Kliničnih izkušenj z naključnim prevelikim odmerjanjem je malo.
In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
V ključnem kliničnem preskušanju učinkovitost in varnost nista bili dokazani (glejte poglavje 5.1).
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
• Obseg napotitve je bil uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo.
Arimidex is contraindicated during pregnancy (see section 4.3).
Zdravilo Arimidex je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
Labelling and Package Leaflet
Označevanje in navodilo za uporabo
The wording for this section of the SPC was similar in most countries.
Besedilo tega poglavja povzetka glavnih značilnosti zdravila je bilo v večini držav podobno.
The CHMP noted the MAH's proposal for section 4.2.
CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom glede poglavja 4.2.
Revised warnings were suggested regarding renal and hepatic impairment.
Predlagana so bila pregledana opozorila v zvezi z okvaro ledvic in jeter.
The CHMP adopted the MAH's proposal with only minor amendments.
CHMP je sprejel predlog imetnika dovoljenja za promet z zdravilom le z majhnimi dopolnili.
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 ne poveča pri bolnikih s hudo okvaro ledvic (GRF<30 ml/min, glejte poglavje 5.2); pri uporabi zdravila Arimidex pri bolnikih s hudo okvaro ledvic je potrebna previdnost (glejte poglavje 4.2).
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).
Ker zdravilo Arimidex znižuje raven estrogena, ki kroži v krvi, lahko povzroči znižanje mineralne gostote kosti in lahko poveča tveganje za zlome (glejte poglavje 4.8).
Administration of Arimidex in patients with hepatic impairment should be performed with caution.
Uporaba zdravila Arimidex pri bolnikih z okvaro jeter je potrebna previdnost.
Vomiting may be induced if the patient is alert.
Če je bolnik buden, se lahko sproži bruhanje.
Section 4.2 Posology and method of administration
Poglavje 4.2 Odmerjanje in način uporabe
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
• Dodatno zdravljenje žensk po menopavzi z zgodnjim invazivnim rakom dojke, pozitivnim na hormonske receptorje, ki so dve do tri leta prejemale dodatni 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 se lahko poveča pri bolnikih z okvaro jeter (glejte poglavje 5.2); pri uporabi zdravila Arimidex pri bolnikih z zmerno in hudo okvaro jeter je potrebna previdnost (glejte poglavje 4.2).
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.4 and 5.2).
Pri bolnikih s hudo okvaro ledvic je pri dajanju zdravila Arimidex potrebna previdnost (glejte poglavji 4.4 in 5. 2).
Arimidex has no or negligible influence on the ability to drive and use machines.
Zdravilo Arimidex ne vpliva na sposobnost vožnje in upravljanja s stroji oz. je njegov vpliv zanemarljiv.
The CHMP agreed with the following wording proposed by the MAH:
CHMP se je strinjal z naslednjim predlaganim besedilom imetnika dovoljenja za promet z zdravilom:
Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
Zdravilo Arimidex ni bilo preučeno pri bolnikih z rakom dojke z zmerno ali hudo okvaro jeter.