FrancophonIA/ELRC3.0 huggingface dataset:
English: EPAR summary for the public ellaOne ulipristal acetate
Slovenian: Povzetek EPAR za javnost ellaOne ulipristalacetat
English: What benefit has ellaOne shown during the studies?
Slovenian: Kakšne koristi je zdravilo ellaOne izkazalo med študijami?
English: For more information about treatment with ellaOne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom ellaOne preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: An additional study compared ellaOne with levonorgestrel (another medicine used in emergency contraception).
Slovenian: V dodatni študiji so zdravilo ellaOne primerjali z levonorgestrelom (drugim zdravilom, uporabljenim kot nujna kontracepcija).
English: This number was then compared with the number of women who would have been expected to become pregnant if they had not taken a contraceptive.
Slovenian: To število so primerjali s številom žensk, ki bi verjetno zanosile, če ne bi vzele kontracepcijskega sredstva.
English: If a woman's menstrual period is late or in case of symptoms of pregnancy, pregnancy should be excluded before ellaOne is taken.
Slovenian: Če menstruacija kasni ali če so opazni simptomi nosečnosti, je treba možnost nosečnosti izključiti, preden se vzame zdravilo ellaOne.
English: The most common side effects with ellaOne are headache, nausea (feeling sick), abdominal pain (stomach ache) and dysmenorrhea (period pains).
Slovenian: Najpogostejši neželeni učinki zdravila ellaOne so glavobol, navzeja (slabost), bolečine v trebuhu in dismenoreja (menstrualne bolečine).
English: A risk management plan has been developed to ensure that ellaOne is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila ellaOne je bil pripravljen načrt obvladovanja tveganj.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ellaOne.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What is the risk associated with ellaOne?
Slovenian: Kakšna tveganja so povezana z zdravilom ellaOne?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure.
Slovenian: V eni glavni študiji je zdravilo ellaOne prejelo 1 533 žensk (povprečne starosti 24 let), ki so potrebovale nujno kontracepcijo od dva do pet dni po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: The medicine can be obtained without a prescription.
Slovenian: Izdaja zdravila je le na recept.
English: For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb.
Slovenian: Da ženska zanosi, mora imeti ovulacijo (sprostitev jajčec), ki ji sledi oploditev jajčeca (združitev s spermijem) in njegova vgnezditev v maternico.
English: EllaOne is a medicine that contains the active substance ulipristal acetate.
Slovenian: EllaOne je zdravilo, ki vsebuje zdravilno učinkovino ulipristalacetat.
English: Through its actions on the progesterone receptors, ellaOne prevents pregnancies mainly by preventing or delaying ovulation.
Slovenian: Z delovanjem na receptorje progesterona zdravilo ellaOne prepreči nosečnost tako, da prepreči ali odloži ovulacijo.
English: The sex hormone progesterone plays a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg.
Slovenian: Spolni hormon progesteron sodeluje pri časovnem uravnavanju ovulacije in pripravi maternice na sprejem oplojenega jajčeca.
English: The active substance in ellaOne, ulipristal acetate, acts as a progesterone receptor modulator.
Slovenian: Zdravilna učinkovina zdravila ellaOne, ulipristalacetat, deluje kot modulator progesteronskih receptorjev.
English: The additional study, which included women who took the medicine within two days of unprotected sex or contraceptive failure, supported the effectiveness of ellaOne.
Slovenian: Dodatna študija, v kateri so ženske vzele zdravilo v dveh dneh po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji, je potrdila učinkovitost zdravila ellaOne.
English: Why has ellaOne been approved?
Slovenian: Zakaj je bilo zdravilo ellaOne odobreno?
English: EllaOne is taken as one tablet by mouth as soon as possible, but no later than 120 hours, after unprotected sex or contraceptive failure.
Slovenian: Zdravilo ellaOne v obliki ene tablete je treba zaužiti peroralno čim prej, vendar najkasneje 120 ur po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.
Slovenian: V tej študiji je bilo zdravilo ellaOne pri preprečevanju nosečnosti enako učinkovito kot levonorgestrel.
English: EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).
Slovenian: Zdravilo ellaOne je nujno kontracepcijsko sredstvo za ženske, ki ga je treba vzeti najkasneje 120 ur (pet dni) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji (na primer, če med spolnim odnosom kondom poči).
English: EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.
Slovenian: Zdravilo ellaOne je bilo pri zmanjšanju števila nenačrtovanih nosečnosti enako učinkovito kot nujno kontracepcijsko sredstvo.
English: This study included women who took the medicine within two days of unprotected sex or contraceptive failure.
Slovenian: V tej študiji so sodelovale ženske, ki so zdravilo vzele najkasneje dva dni po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
English: What is ellaOne used for?
Slovenian: Za kaj se zdravilo ellaOne uporablja?
English: How does ellaOne work?
Slovenian: Kako zdravilo ellaOne deluje?
English: How has ellaOne been studied?
Slovenian: Kako je bilo zdravilo ellaOne raziskano?
English: What is ellaOne?
Slovenian: Kaj je zdravilo ellaOne?
English: How is ellaOne used?
Slovenian: Kako se zdravilo ellaOne uporablja?
English: # at risk months months
Slovenian: # ob tveganju mesecev mesecev
English: The potential risk for humans is unknown.
Slovenian: Možno tveganje za ljudi ni znano.
English: This “treatment cycle” will be repeated every 4 weeks.
Slovenian: Ta „cikel zdravljenja“ se ponovi vsake 4 tedne.
English: (% of recommended starting dose)
Slovenian: (% priporočenega začetnega odmerka)
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: After reconstitution:
Slovenian: Po rekonstituciji:
English: Your doctor will check your progress and may change your dose if necessary.
Slovenian: Vaš zdravnik bo preveril napredek in lahko po potrebi spremeni odmerek.
English: • Loss of appetite.
Slovenian: • izguba apetita
English: Response was assessed by the investigator or by the Independent Review Committee (IRC).
Slovenian: Odziv je ocenil raziskovalec ali neodvisni odbor za pregled (Independent Review Committee - IRC).
English: The primary endpoint of the study was overall survival.
Slovenian: Primarni cilj študije je bilo celokupno preživetje.
English: Unopened powder vial: 4 years
Slovenian: Neodprta viala s praškom: 4 leta
English: From a microbiological point of view, the reconstituted product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba rekonstituirano zdravilo uporabiti takoj.
English: Patients with secondary MDS were excluded from the study.
Slovenian: Bolniki s sekundarno MDS so bili izključeni iz študije.
English: Treatment should be continued as long as the patient continues to benefit or until disease progression.
Slovenian: Zdravljenje je treba nadaljevati tako dolgo, dokler bolniku koristi ali dokler bolezen ne napreduje.
English: Other side effects include:
Slovenian: Med druge neželene učinke spadajo:
English: HRQoL data could be analysed for a subset of the full trial population.
Slovenian: Podatke HRQoL je mogoče analizirati po podskupinah celotne populacije preskušanja.
English: Tell your doctor straight away if you notice any of the following side effects:
Slovenian: Takoj obvestite svojega zdravnika, če opazite kateregakoli od naslednjih neželenih učinkov:
English: This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Slovenian: Na tak način se preveri, ali imate dovolj krvnih celic in ali vaša jetra in ledvice pravilno delujejo.
English: Total volume of reconstituted suspension required
Slovenian: Celotni volumen potrebne rekonstituirane suspenzije
English: The differences between the IRC and investigator assessments of response were a consequence of the International Working Group (IWG) criteria requiring improvement in peripheral blood counts and maintenance of these improvements for a minimum of 56 days.
Slovenian: Razlike med ocenami odziva IRC in raziskovalca so bile posledica kriterijev Mednarodne delovne skupine (IWGInternational Working Group), ki so zahtevali izboljšanje vrednosti periferne krvi in vzdrževanje teh izboljšanj vsaj 56 dni.
English: Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary.
Slovenian: Na podlagi rezultatov študij na živalih in mehanizma delovanja se azacitidina ne sme uporabljati med nosečnostjo, še zlasti ne v prvem trimesečju, razen če je to nujno.
English: Laboratory tests
Slovenian: Laboratorijski testi
English: Proportion Surviving
Slovenian: Sorazmerno preživetje
English: The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Vidaza pri otrocih, starih 0 do 17 let, še nista bili dokazani.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: Non-proliferating cells are relatively insensitive to azacitidine.
Slovenian: Neproliferativne celice so relativno neobčutljive na azacitidin.
English: Calculation of an individual dose The total dose, according to the body surface area (BSA) can be calculated as follows:
Slovenian: Izračun individualnega odmerka Celotni odmerek glede na površino telesa (BSA - body surface area) se izračuna tako:
English: Following dose modifications, the cycle duration should return to 28 days.
Slovenian: Po spremembi odmerka mora biti dolžina cikla ponovno 28 dni.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in na škatli.
English: Children and adolescents Vidaza is not recommended for use in children and adolescents below the age of 18.
Slovenian: Otroci in mladostniki Uporaba zdravila Vidaza ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
English: Your doctor will decide your dose of this medicine, depending on your general condition, height and weight.
Slovenian: Zdravnik bo določil odmerek tega zdravila glede na vaše splošno počutje, vašo višino in telesno maso.
English: When more than 1 vial is needed all the above steps for preparation of the suspension should be repeated.
Slovenian: Kadar je potrebna več kot 1 viala, ponovite vse zgornje korake za pripravo suspenzije.
English: However, exposure was within the same general range of exposures observed for subjects with normal renal function.
Slovenian: Vendar pa je bila izpostavljenost znotraj istega splošnega razpona izpostavljenosti, ki so jih opažali pri osebah z normalno ledvično funkcijo.
English: These patients should be monitored closely and appropriate precautions taken.
Slovenian: Te bolnike je treba skrbno spremljati in pri njih uvesti ustrezne previdnostne ukrepe.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: • if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na azacitidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: It is not known if this medicine passes into human milk.
Slovenian: Ni znano, ali to zdravilo prehaja v materino mleko.
English: The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
Slovenian: Naslednja preglednica je prikazana samo kot primer izračuna za pripravo individualnih odmerkov azacitidina na podlagi povprečne vrednosti BSA, ki je 1,8 m2.
English: They are also responsible for preparing and disposing of any unused Vidaza correctly.
Slovenian: Odgovoren je tudi za pravilno pripravo in odstranitev neuporabljenega zdravila Vidaza.
English: No specific dose adjustments are recommended for the elderly.
Slovenian: Ni priporočil o posebnih prilagajanjih odmerka za starejše ljudi.
English: Date of latest renewal: 13 November 2013
Slovenian: Datum prve odobritve: 17. december 2008 Datum zadnjega podaljšanja: 13. november 2013
English: Haematologic and cytogenetic responses were assessed by the investigator and by the IRC with similar results.
Slovenian: Hematološke in citogenetske odzive so ocenjevali raziskovalec in IRC s podobnimi rezultati.
English: Necrotising fasciitis
Slovenian: Nekrotizantni fasciitis
English: Bleeding may occur with patients receiving azacitidine.
Slovenian: Krvavitev se lahko pojavi pri bolnikih, ki prejemajo azacitidin.
English: You should not use Vidaza during pregnancy as it may be harmful to the baby.
Slovenian: Med nosečnostjo ne uporabljajte zdravila Vidaza, ker lahko škodi otroku.
English: Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Slovenian: Pogovorite se z zdravnikom, če želite pred začetkom zdravljenja shraniti svojo spermo.
English: Therefore, caution is recommended when driving or operating machines.
Slovenian: Zato se pri vožnji ali upravljanju strojev priporoča previdnost.
English: It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the medicinal product after reconstitution.
Slovenian: Upoštevati morate, da so filtri nameščeni v nekaterih adapterjih, konicah in zaprtih sistemih; zato se taki sistemi ne smejo uporabljati za dajanje zdravila po rekonstituciji.
English: 2 vials
Slovenian: 2 viali
English: • Vidaza is given every day for one week, followed by a rest period of 3 weeks.
Slovenian: • Zdravilo Vidaza boste en teden prejemali vsak dan, nato sledi tritedensko obdobje mirovanja.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below (see “Reconstitution Procedure”).
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v nadaljevanju (glejte „Postopek rekonstitucije“).
English: Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Slovenian: Ker je pri starejših bolnikih večja verjetnost zmanjšane ledvične funkcije, je morda koristno spremljati delovanje ledvic.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Azacitidine has minor or moderate influence on the ability to drive and use machines.
Slovenian: Azacitidin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Adverse reactions are presented in the table below according to the highest frequency observed in any of the main clinical studies.
Slovenian: Neželeni učinki so predstavljeni v spodnji preglednici v skladu z največjo pogostnostjo, ki so jo opazili v kateri koli od glavnih kliničnih študij.
English: • High or low blood pressure (hypertension or hypotension).
Slovenian: • visok ali nizek krvni tlak (hipertenzija ali hipotenzija)
English: The potential carcinogenicity of azacitidine was evaluated in mice and rats.
Slovenian: Potencialno karcinogenost azacitidina so ocenili pri miših in podganah.
English: • Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
Slovenian: • sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka in včasih celo brez zdravljenja.
English: Myelosuppression may lead to neutropenia and an increased risk of infection.
Slovenian: Mielosupresija lahko povzroči nevtropenijo in poveča tveganje za okužbe.
English: Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
Slovenian: Neželeni učinki, ki so morda ali verjetno povezani z zdravljenjem z zdravilom Vidaza, so se pojavili pri 97 % bolnikov.
English: On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years, ≥ 65 years and ≥ 75 years).
Slovenian: V analizah starostnih podskupin so v vseh skupinah opazili podaljšanje mediane celokupnega preživetja (< 65 let, ≥ 65 let in ≥ 75 let).
English: This may be due to an allergic (hypersensitivity) reaction.
Slovenian: Vzrok je lahko alergijska (preobčutljivostna) reakcija.
English: These cutaneous reactions have to be distinguished from soft tissue infections, sometimes occurring at injection site.
Slovenian: Te kožne reakcije je treba razlikovati od okužb mehkih tkiv, ki se včasih pojavijo na mestu injiciranja.
English: The product should be discarded if it contains large particles or agglomerates.
Slovenian: Zdravilo zavrzite, če vsebuje večje delce ali aglomerate.
English: While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with Vidaza.
Slovenian: Čeprav so v analizi nekatere omejitve, podatki, ki so na voljo, kažejo, da pri bolnikih med zdravljenjem z zdravilom Vidaza ne pride do pomembnega poslabšanja kakovosti življenja.
English: The requirements for submission of periodic safety update reports for this medicinal are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
English: Details on storage of the reconstituted product are provided below.
Slovenian: Podrobnosti o shranjevanju rekonstituiranega zdravila so navedene spodaj.
English: The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Slovenian: Rezultati, predstavljeni v nadaljevanju, predstavljajo populacijo, namenjeno za zdravljenje, ki so jo proučili v študiji AZA-AML-001 (glejte poglavje 4.1 za odobreno indikacijo).
English: Doses greater than 4 mL should be injected into two separate sites.
Slovenian: Odmerke, večje kot 4 ml, injicirajte na dve različni mesti.
English: Procedures for proper handling and disposal of anticancer medicinal products should be applied.
Slovenian: Upoštevati je treba postopke za pravilno ravnanje z zdravili proti raku in njihovo odstranjevanje.
English: It is therefore advised to exercise caution when prescribing azacitidine to these patients.
Slovenian: Zato se pri predpisovanju azacitidina tem bolnikom priporoča previdnost.
English: Cardiopulmonary assessment before and during the treatment should be considered.
Slovenian: Razmisliti je treba o kardiopulmonarni oceni pred zdravljenjem in med njim.
English: Prognostic Scoring System (IPSS),
Slovenian: Mednarodnem prognostičnem sistemu ocenjevanja (IPSS - International Prognostic Scoring
English: Pack size: 1 vial
Slovenian: Pakiranje: 1 viala.
English: Following intravenous administration, the mean volume of distribution was 76 ± 26 L, and systemic clearance was 147 ± 47 L/h.
Slovenian: Po intravenskem dajanju je bil povprečni porazdelitveni volumen 76 ± 26 l in sistemski očistek 147 ± 47 l/h.
English: • Red or purple spots under your skin.
Slovenian: • rdeče ali vijolične lise pod kožo
English: Do not use Vidaza
Slovenian: Ne uporabljajte zdravila Vidaza
English: What you need to know before you use Vidaza
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Vidaza
English: In the event of overdose, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika spremljati z ustreznimi pregledi krvne slike in mu po potrebi nuditi podporno zdravljenje.
English: Health- Related Quality of Life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Slovenian: Z zdravjem povezano kakovost življenja (HRQoL - Health-Related Quality of Life) so ocenjevali z osnovnim vprašalnikom o kakovosti življenja Evropske organizacije za raziskovanje in zdravljenje raka (EORTC QLQ-C30 - European Organization for Research and Treatment of Cancer Core
English: It is recommended that patients be treated for a minimum of 6 cycles.
Slovenian: Priporočeno je, da se bolnike zdravi vsaj 6 ciklov.
English: You will usually receive at least 6 treatment cycles.
Slovenian: Običajno je ciklov zdravljenja vsaj 6.
English: • The recommended dose is 75 mg per m2 body surface area.
Slovenian: • Priporočeni odmerek je 75 mg/m2 površine telesa.
English: For immediate use
Slovenian: Za takojšnjo uporabo