FrancophonIA/ELRC3.0 huggingface dataset:
English: This study also involved 23 children aged 8 to 11 years weighing at least 25 kg, and showed that after 48 weeks of treatment with Genvoya the viral load was reduced to less than 50 copies/ml in all patients.
Slovenian: V tej študiji je sodelovalo tudi 23 otrok, starih od 8 do 11 let, s telesno maso najmanj 25 kg, pri čemer se je pri vseh bolnikih po 48 tednih zdravljenja z zdravilom Genvoya virusna obremenitev zmanjšala na manj kot 50 kopij/ml.
English: The fourth, tenofovir alafenamide, is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Slovenian: Četrta, alafenamidtenofovirat, je učinkovita pri nižjih odmerkih od uveljavljenega zdravila dizoproksiltenofovirat in ponuja možnost zmanjšanja neželenih učinkov.
English: The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.
Slovenian: Njihova virusna obremenitev je bila po 24 tednih zmanjšana na manj kot 50 kopij/ml pri 90 % (45 od 50) bolnikov.
English: Genvoya does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo ne zdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Slovenian: Ti zavirajo delovanje reverzne transkriptaze, tj. virusnega encima, ki omogoča, da se HIV-1 razmnožuje v celicah, ki jih je okužil.
English: By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.
Slovenian: Zdravilo Genvoya z zaviranjem reverzne transkriptaze zniža količino virusa HIV-1 v krvi in jo zadržuje na nizki ravni.
English: It is not intended to provide practical advice on how to use Genvoya.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Genvoya approved?
Slovenian: Zakaj je bilo zdravilo Genvoya odobreno?
English: For the full list of all side effects reported with Genvoya, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Genvoya, glejte navodilo za uporabo.
English: For practical information about using Genvoya, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Genvoya naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Three of the active substances, elvitegravir, cobicistat and emtricitabine have already been shown to be effective.
Slovenian: Tri od teh zdravilnih učinkovin, elvitegravir, kobicistat in emtricitabin, so se že izkazali za učinkovite.
English: After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.
Slovenian: Preiskave so po 48 tednih pokazale virusno obremenitev manj kot 50 kopij/ml pri 97 % (932 od 959) bolnikov, ki so prešli na uporabo zdravila Genvoya, in 93 % (444 od 477) bolnikov, ki so nadaljevali jemanje svojih običajnih zdravil.
English: In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously.
Slovenian: V drugi študiji so zdravilo Genvoya dali mladostnikom, starim 12 do 18 let, okuženim z virusom HIV-1, ki niso bili predhodno zdravljeni.
English: Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Slovenian: Alafenamidtenofovirat je „predzdravilo“ tenofovirja, kar pomeni, da se v zdravilno učinkovino tenofovir pretvori v telesu.
English: Genvoya can also be used in children aged over 6 years who cannot tolerate other HIV-1 treatments because of side effects.
Slovenian: Zdravilo Genvoya se lahko uporablja tudi pri otrocih, starejših od šest let, ki zaradi neželenih učinkov ne morejo prenašati drugih zdravil za zdravljenje okužb z virusom HIV-1.
English: Cobicistat increases the level of elvitegravir by slowing its breakdown.
Slovenian: Kobicistat poviša raven elvitegravirja v krvi, tako da upočasni njegov razkroj.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Genvoya je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
English: Elvitegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Slovenian: Elvitegravir je vrsta protivirusnega sredstva, imenovanega „zaviralec integraze“.
English: Tenofovir alafenamide had a milder effect on the kidney than tenofovir disoproxil.
Slovenian: Alafenamidtenofovirat je imel blažji učinek na ledvice kot dizoproksiltenofovirat.
English: In studies, the effectiveness of Genvoya was high and comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Slovenian: V študijah je bila učinkovitost zdravila Genvoya visoka in primerljiva z zdravilom, ki vsebuje elvitegravir, kobicistat, emtricitabin in dizoproksiltenofovirat.
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Slovenian: Tenofovir in emtricitabin sta sorodni protivirusni učinkovini, ki spadata med zaviralce reverzne transkriptaze.
English: In both studies, Genvoya was compared with another antiviral medicine which contained the active ingredients elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Slovenian: V obeh študijah so zdravilo Genvoya primerjali z drugim protivirusnim zdravilom, ki je vsebovalo zdravilne učinkovine elvitegravir, kobicistat, emtricitabin in dizoproksiltenofovirat.
English: How does Genvoya work?
Slovenian: Kako zdravilo Genvoya deluje?
English: How is Genvoya used?
Slovenian: Kako se zdravilo Genvoya uporablja?
English: Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Slovenian: Zdravilo Genvoya vsebuje zdravilne učinkovine elvitegravir, kobicistat, emtricitabin in alafenamidtenofovirat.
English: Long-term safety data in children and adolescents are not available.
Slovenian: Dolgoročnih podatkov o varnosti pri otrocih in mladostnikih ni na voljo.
English: The remaining 10 countries do not currently have wording to this effect.
Slovenian: V preostalih 10 državah v zvezi s tem trenutno ni besedila.
English: Stability
Slovenian: Stabilnost
English: In all other EU-countries, approval has been granted through national procedures.
Slovenian: V vseh drugih državah EU je bilo zdravilo odobreno z nacionalnimi postopki.
English: In all cases the results were within the approved specifications.
Slovenian: V vseh primerih so bili rezultati v mejah odobrenih specifikacij.
English: Arimidex was first approved on 1995 in the UK and via a MRP procedure in Austria, Germany, Italy, Portugal and Spain.
Slovenian: Zdravilo Arimidex je bilo prvič odobreno leta 1995 v Združenem kraljestvu in s postopkom z medsebojnim priznavanjem v Avstriji, Nemčiji, Italiji, na Portugalskem in v Španiji.
English: Section 4.8 Undesirable effects
Slovenian: Poglavje 4.8 Neželeni učinki
English: The list of manufacturers in the harmonised version of the dossier has been updated and the sites no longer in use have not been included.
Slovenian: Seznam proizvajalcev v usklajeni različici dokumentacije je bil posodobljen in lokacije, ki se ne uporabljajo več, niso bile vključene.
English: Identical wording for this indication exists in 19 out of the 29 countries where Arimidex is approved.
Slovenian: Enako besedilo za to indikacijo je v 19 od 29 držav, v katerih je zdravilo Arimidex odobreno.
English: Treatment should be based on a benefit-risk evaluation for the individual patient.
Slovenian: Zdravljenje mora temeljiti na oceni razmerja med tveganji in koristmi za vsakega posameznega bolnika.
English: Overall summary of the scientific evaluation of Arimidex
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Arimidex
English: Estrone is subsequently converted to estradiol.
Slovenian: Estron se naknadno pretvori v estradiol.
English: Specifications
Slovenian: Specifikacije
English: Section 4.6 Fertility, pregnancy and lactation
Slovenian: Poglavje 4.6 Plodnost, nosečnost in dojenje
English: General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Slovenian: Indicirana je splošna podporna oskrba, vključno s pogostim spremljanjem življenjskih znakov in skrbnim opazovanjem bolnika.
English: The effect of potent CYP inhibitors is unknown.
Slovenian: Učinek močnih zaviralcev CYP je neznan.
English: Clinical aspects
Slovenian: Klinični vidiki
English: The Committee considered that most of the contraindications proposed were not appropriate as such, given that they reflected the lack of relevant data rather than absolute contraindications.
Slovenian: Odbor je menil, da večina predlaganih kontraindikacij ni ustreznih, saj so odražale predvsem pomanjkanje ustreznih podatkov in ne absolutne kontraindikacije.
English: Arimidex tablets are very stable under the conditions recommended in the product information, i.e. “store under 30°C”
Slovenian: Tablete zdravila Arimidex so zelo stabilne pod pogoji, ki so priporočeni v informacijah o zdravilu, na primer „shranjujte pri temperaturi pod 30 °C“.
English: There is no specific antidote to overdose and treatment must be symptomatic.
Slovenian: Za preveliko odmerjanje ni posebnega antidota, zdravljenje pa mora biti simptomatsko.
English: • Patients with known hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.
Slovenian: • bolnikih z znano preobčutljivostjo za anastrozol ali katero koli pomožno snov, ki so navedene v poglavju 6.1.
English: The wording for this section did not significantly differ between countries.
Slovenian: Besedilo v tem poglavju se med posameznimi državami ni bistveno razlikovalo.
English: One of the main inclusion criteria for this study was histologically proven operable invasive breast cancer.
Slovenian: Eno od glavnih meril za vključitev v to študijo je bil histološko dokazan operabilen invazivni rak dojke.
English: Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro.
Slovenian: Anastrozol in vitro zavira encime CYP 1A2, 2C8/9 in 3A4.
English: A subheading on fertility was also introduced.
Slovenian: Vključeno je bilo tudi podpoglavje o plodnosti.
English: • Pregnant or breast-feeding women.
Slovenian: • nosečih ali doječih ženskah;
English: The MAH presented a proposal for section 4.3 which was based on the currently existing contraindications in the different countries.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil predlog za poglavje 4.3, ki je bil zasnovan na trenutno obstoječih kontraindikacijah v različnih državah.
English: The majority of the Member States currently have the same wording or wording within the same meaning with respect of this indication.
Slovenian: V zvezi s to indikacijo ima trenutno večina držav članic enako besedilo oziroma besedilo z enakim pomenom.
English: In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken.
Slovenian: V primeru prevelikega odmerjanja je treba upoštevati tudi možnost, da je bilo uporabljenih več zdravil.
English: The wording on posology did not differ significantly across Member States, but recommendations on use in renal and hepatic impairment were not harmonised.
Slovenian: Besedilo o odmerjanju se med državami članicami ni bistveno razlikovalo, vendar priporočila o uporabi pri okvari ledvic in jeter niso bila usklajena.
English: Other changes were introduced in the description of the clinical trials supporting the indication to clarify and streamline the information for the prescriber.
Slovenian: V opis kliničnih preskušanj so bile dodane druge spremembe, ki podpirajo to indikacijo, za pojasnitev in poenostavitev informacij za predpisovalce.
English: ‘Premenopausal women' and ‘patients with concomitant tamoxifen therapy' were deleted from this section and information moved to section 4.4.
Slovenian: „Ženske pred menopavzo“ in „bolniki s sočasno terapijo s tamoksifenom“ so bili iz tega poglavja izbrisani, informacije pa prestavljene v poglavje 4.4.
English: This was accepted but 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 data.
Slovenian: To je bilo sprejeto, vendar bo morda potreben popravek zaradi trenutno potekajočega postopka za ocenjevanje teh podatkov, ki poteka v skladu s členom 45 Uredbe 1901/2006, kakor je bila spremenjena.
English: Quality aspects
Slovenian: Vidiki kakovosti
English: Arimidex is contraindicated in:
Slovenian: Zdravilo Arimidex je kontraindicirano pri:
English: The Committee considered that available study results and current scientific knowledge allow for more detailed and informative wording on the potential for cytochrome P450 interactions.
Slovenian: Odbor je menil, da razpoložljivi rezultati študij in trenutno znanstveno znanje omogočajo natančnejše in bolj informativno besedilo o možnih interakcijah zaradi citokroma P450.
English: The active substance is stable under the conditions specified in the dossier.
Slovenian: Zdravilna učinkovina je v pogojih, opredeljenih v dokumentaciji, stabilna.
English: Hypersensitivity to lactose
Slovenian: Preobčutljivost za laktozo
English: Effect on bone mineral density
Slovenian: Vpliv na mineralno gostoto kosti
English: The indications were essentially the same but worded differently in the various countries.
Slovenian: Indikacije v različnih državah so bile v bistvu enake, vendar so imele drugačno besedilo.
English: In animal studies, anastrozole demonstrated low acute toxicity.
Slovenian: V študijah pri živalih se je pokazala nizka akutna toksičnost anastrozola.
English: Stability data from production scale batches of the active substance and drug product which was already approved in some member states was presented.
Slovenian: Predstavljeni so bili podatki o stabilnosti iz proizvodnih serij zdravilne učinkovine in zdravila, ki je bilo v nekaterih državah članicah že odobreno.
English: There were no clinically significant interactions with bisphosphonates (see section 5.1).
Slovenian: Prav tako ni bilo klinično pomembnih interakcij z bisfosfonati (glejte poglavje 5.1).
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product,the European Commission notified the CHMP/European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC as amended, in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Slovenian: Zaradi različnih nacionalnih odločitev držav članic o odobritvi dovoljenj za promet z navedenim zdravilom (in povezanimi imeni) je Evropska komisija obvestila CHMP/Evropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi se razrešile razlike med nacionalno odobrenimi povzetki glavnih značilnosti zdravila in s tem uskladili različni povzetki glavnih značilnosti zdravila v EU.
English: In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Slovenian: Pri ženskah po menopavzi se estradiol proizvaja predvsem s pretvorbo androstenediona v estron z encimskim kompleksom aromataze v perifernih tkivih.
English: 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.
Slovenian: 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.
English: The drug product specification complies with all relevant guidelines and standards.
Slovenian: Specifikacija za zdravilo je v skladu z vsemi zadevnimi smernicami in standardi.
English: Harmonised versions of the labelling and of the package leaflet were adopted.
Slovenian: Sprejete so bile usklajene različice za označevanje in navodilo za uporabo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: CHMP je zahteval, da se ta izjava izbriše, saj nasprotuje vključitvi hiperholesterolemije kot pogostega neželenega učinka v poglavje 4.8.
English: The final adopted wording on use in renal and hepatic impairment is as follows:
Slovenian: Končno potrjeno besedilo glede uporabe pri okvari ledvic in jeter je:
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: This product contains lactose.
Slovenian: Zdravilo vsebuje laktozo.
English: Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Slovenian: Cimetidin, šibek in nespecifičen zaviralec encimov CYP, ni vplival na plazemske koncentracije anastrozola.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Section 4.4 Special warnings and precautions for use
Slovenian: Poglavje 4.4 Posebna opozorila in previdnostni ukrepi
English: Section 4.1 Therapeutic indications
Slovenian: Poglavje 4.1 Terapevtske indikacije
English: Section 5.3 Preclinical safety data
Slovenian: Poglavje 5.3 Predklinični podatki o varnosti
English: 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.
Slovenian: 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.
English: Summary of Product Characteristics
Slovenian: Povzetek glavnih značilnosti zdravila
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
English: The CHMP noted the MAH's proposal for section 4.4 and agreed with the majority of the content.
Slovenian: CHMP je upošteval predlog imetnika dovoljenja za promet z zdravilom za poglavje 4.4 in se strinjal z večino vsebine.
English: 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.
Slovenian: 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.
English: The active substance specification complies with all relevant guidelines and standards.
Slovenian: Specifikacija za zdravilno učinkovino je v skladu z vsemi zadevnimi smernicami in standardi.
English: Section 4.3 Contraindications
Slovenian: Poglavje 4. 3 Kontraindikacije
English: The CHMP noted that the MAH did not suggest its inclusion as part of the harmonised indication, and agreed to this.
Slovenian: CHMP je izpostavil, da imetnik dovoljenja za promet z zdravilom ni predlagal vključitve tega dela v usklajene indikacije in se s tem strinjal.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.