FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is required in patients over the age of 65 years.
Slovenian: Prilagajanje odmerka pri bolnikih, starejših od 65 let, ni potrebno.
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Slovenian: Tadalafil ni vplival na izpostavljenost (AUC in Cmax) bosentanu ali njegovim presnovkom.
English: It is not known whether bosentan is excreted into human breast milk.
Slovenian: Ni znano, ali se bosentan izloča v materino mleko.
English: This interaction is unlikely to be of clinical relevance.
Slovenian: Malo verjetno je, da bi bilo to medsebojno delovanje klinično pomembno.
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking STAYVEER.
Slovenian: Vaš zdravnik ali ginekolog vam bo svetoval glede zanesljivih kontracepcijskih metod v času jemanja zdravila STAYVEER.
English: However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects.
Slovenian: Pri posameznicah pa so bila zmanjšanja izpostavljenosti tudi do 56 % oziroma 66 %.
English: Monitoring of cholesterol levels and subsequent dosage adjustment should be considered.
Slovenian: Razmislite o spremljanju ravni holesterola in posledično prilagoditvi odmerka.
English: If you notice any of these signs tell your doctor immediately
Slovenian: Če opazite katerega od teh znakov, nemudoma obvestite svojega zdravnika.
English: It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter.
Slovenian: Priporočamo, da koncentracije hemoglobina preverite pred začetkom zdravljenja, vsak mesec v prvih štirih mesecih, zatem pa vsako četrtletje.
English: Your doctor may tell you to reduce the dose over a few days before stopping completely.
Slovenian: Vaš zdravnik vam bo morda odmerek postopoma zniževal (nekaj dni), preden popolnoma prekinete z zdravljenjem.
English: Half of the patients in each group were already being treated with intravenous epoprostenol and the dose of epoprostenol remained constant for the duration of the study.
Slovenian: Polovica bolnikov v vsaki skupini je že prejemala epoprostenol intravensko, odmerek epoprostenola je med trajanjem študije ostal nespremenjen.
English: • Abnormal liver function which may affect more than 1 in 10 people
Slovenian: • nenormalno delovanje jeter, ki se lahko pojavi pri več kot 1 od 10 bolnikov
English: Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant.
Slovenian: Spremembe parametrov za vadbeni preskus so bile v 12. tednu glede na izhodiščne vrednosti zelo spremenljive in nobena ni bila značilna.
English: Controlled clinical study experience in this indication is limited to 6 months (see section 5.1).
Slovenian: Izkušnje iz nadzorovane klinične študije so pri tej indikaciji omejene na 6 mesecev (glejte poglavje
English: Consequently, it is recommended that patients be monitored for signs of fluid retention (e.g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Slovenian: Zato priporočamo, da bolnike opazujete glede pojava znakov zadrževanja tekočine (denimo, povečanje telesne mase) in to še zlasti, če imajo sočasno hudo sistolično disfunkcijo.
English: The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%).
Slovenian: Varnostni profil v tej združeni analizi nenadzorovanih pediatričnih študij je bil podoben kot v ključnih preskušanjih pri odraslih bolnikih s PAH, z izjemo okužb, o katerih so poročali pogosteje kot pri odraslih (69,0 % v primerjavi z 41,3 %).
English: Clearance and volume of distribution decrease with increased intravenous doses and increase with time.
Slovenian: Očistek in volumen porazdelitve se zmanjšujeta z višanjem intravenskega odmerka in večata s časom.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The relative contributions of previous placebo treatment in the double-blind phase and of other medications started during the open-label extension period are unknown.
Slovenian: Relativni prispevek predhodnega zdravljenja s placebom v dvojno slepi fazi in druga zdravila, uvedena v obdobju odprtega podaljška, niso znani.
English: 1 Data derived from post-marketing experience, frequencies based on statistical modelling of placebo-controlled clinical trial data.
Slovenian: 1 Pogostnosti pri podatkih, pridobljenih iz izkušenj v obdobju trženja, temeljijo na statističnem modelu podatkov s placebom kontroliranih kliničnih preskušanj.
English: Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
Slovenian: Farmakoterapevtska skupina: drugi antihipertenzivi, oznaka ATC: C02KX01 Mehanizem delovanja
English: Therefore, if you feel dizzy or that your vision is blurred while taking STAYVEER, do not drive or operate any tools or machines.
Slovenian: Če ste v času jemanja zdravila STAYVEER omotični ali imate zamegljen vid, ne vozite in ne upravljajte nobenega orodja ali strojev.
English: No recommendation on a posology can be made (see sections 5.1 and 5.2).
Slovenian: Priporočil o odmerjanju ni mogoče dati (glejte poglavji 5.1 in 5.2).
English: • Neutropenia/leukopenia (low number of white blood cells)
Slovenian: • nevtropenija/levkopenija (nizko število belih krvničk)
English: Re-introduction must follow the guidelines detailed in section 4.2.
Slovenian: Pri ponovni uvedbi zdravljenja se ravnamo po smernicah, opisanih v poglavju 4.2.
English: STAYVEER is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Slovenian: Zdravilo STAYVEER se uporablja za zdravljenje bolnikov s PAH III. razreda za izboljšanje zmožnosti vadbe (zmožnost izvajanja fizične dejavnosti) in simptomov.
English: In the clinical programme, dose-dependent elevations in liver aminotransferases generally occurred within the first 26 weeks of treatment, usually developed gradually, and were mainly asymptomatic.
Slovenian: V kliničnem programu so se od odmerka odvisna zvišanja jetrnih aminotransferaz na splošno pojavila v prvih 26 tednih zdravljenja, običajno so se razvijale postopoma in so bile večinoma brez simptomov.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking STAYVEER, and regularly while you are taking STAYVEER.
Slovenian: Če ste ženska, ki želi zanositi, vam bo zdravnik naročil, da opravite test nosečnosti, preden začnete jemati zdravilo STAYVEER, nato pa redno v času jemanja zdravila STAYVEER.
English: In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Slovenian: Podatki in vitro so pokazali, da bosentan ni imel nobenega pravega zaviralnega učinka na testirane izoencime CYP (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
English: • Palpitations (fast or irregular heart beats)
Slovenian: • palpitacije (hitro ali nepravilno bitje srca)
English: 40.6% (26/64) remained on bosentan monotherapy during the 24 weeks of study treatment without experiencing PAH worsening.
Slovenian: 40,6 % (26/64) jih je ostalo na monoterapiji z bosentanom med 24-tedenskim študijskim zdravljenjem, ne da bi doživeli poslabšanje
English: The improvement in walk distance was apparent after 4 weeks of treatment, was clearly evident after 8 weeks of treatment and was maintained for up to 28 weeks of double-blind treatment in a subset of the patient population.
Slovenian: Podaljšanje prehojene razdalje je bilo opazno po 4 tednih zdravljenja, očitno po 8 tednih zdravljenja in je vztrajalo vseh 28 tednov dvojno slepega zdravljenja v podskupini populacije bolnikov.
English: Note: bosentan is not removed through dialysis.
Slovenian: Opomba: bosentan se z dializo ne odstrani.
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Slovenian: Dolgoročni podatki so pridobljeni na podlagi vseh 173 bolnikov, zdravljenih z bosentanom v kontrolirani fazi in/ali ki so prešli s placeba na bosentan v fazi odprtega podaljšanja študije EARLY.
English: An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Slovenian: Zvišanja dolgoročnega tveganja jetrne toksičnosti in neželenih hematoloških učinkov ni mogoče izključiti, ko se bosentan uporablja v kombinaciji z antiretrovirusnimi zdravili.
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Slovenian: • druga zdravila za zdravljenje pljučne hipertenzije: sildenafil in tadalafil,
English: The influence of CYP2C9 inhibitors on bosentan concentration has not been studied.
Slovenian: Vpliva zaviralcev CYP2C9 na koncentracijo bosentana niso preučili.
English: This difference in infection frequency may in part be due to the longer median treatment exposure in the paediatric set (median 71.8 weeks) compared with the adult set (median 17.4 weeks).
Slovenian: To razliko v pogostnosti okužb bi lahko delno pripisali daljši mediani izpostavljenosti zdravljenju pri pediatričnih preiskovancih (mediana 71,8 tednov) v primerjavi z odraslimi preiskovanci (mediana 17,4 tedne).
English: If any of these apply to you, tell your doctor.
Slovenian: Če karkoli od tega velja za vas, obvestite zdravnika.
English: ‘Class II' involves slight limitation of physical activity.
Slovenian: razred' pomeni znatno omejitev fizične aktivnosti.
English: Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period.
Slovenian: Osnovna zdravljenja za sistemsko sklerozo in razjede prstov so bila dovoljena, če so ostala nespremenjena vsaj en mesec pred začetkom zdravljenja in med dvojno slepo študijo.
English: Bosentan forms three metabolites and only one of these is pharmacologically active.
Slovenian: Pri presnovi bosentana nastanejo trije presnovki in samo eden med njimi je farmakološko aktiven.
English: If you are a man taking STAYVEER, it is possible that this medicine may lower your sperm count.
Slovenian: Če ste moški in jemljete zdravilo STAYVEER, je možno, da lahko to zdravilo zmanjša število semenčic.
English: Women of childbearing age
Slovenian: Ženske v rodni dobi
English: Tablets are to be taken orally morning and evening, with or without food.
Slovenian: Tablete je treba zaužiti zjutraj in zvečer, s hrano ali brez nje.
English: The median treatment duration was 71.8 weeks (range 0.4-258 weeks).
Slovenian: Mediano trajanje zdravljenja je bilo 71,8 tednov (razpon 0,4-258 tednov).
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Slovenian: • posledica skleroderme (imenovane tudi sistemska skleroza, bolezen nenormalne rasti vezivnega tkiva, ki podpira kožo in druge organe),
English: Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Slovenian: Vaš zdravnik in/ali ginekolog bo ugotovil, katera kontracepcija je za vas najprimernejša,
English: What STAYVEER is and what it is used for What you need to know before you take STAYVEER How to take STAYVEER
Slovenian: Kaj je zdravilo STAYVEER in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo STAYVEER Kako jemati zdravilo STAYVEER
English: Due to the marked hepatotoxicity of nevirapine, which could add to bosentan liver toxicity, this combination is not recommended.
Slovenian: Zaradi izrazite hepatotoksičnosti nevirapina, ki bi lahko dodatno povečala toksičnost za jetra, ki jo povzroči bosentan, se ta kombinacija ne priporoča.
English: Do not store above 30 °C.
Slovenian: Shranjujte pri temperaturi do 30 °C
English: No If Yes, write the names of these here:
Slovenian: Če ste odgovorili z Da, napišite, kaj uporabljate:
English: Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Slovenian: Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom STAYVEER ni dovoljena.
English: In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
Slovenian: Poleg tega moramo ravni jetrnih aminotransferaz izmeriti 2 tedna po vsakem povišanju odmerka.
English: In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.
Slovenian: Pri otrocih moškega spola dolgoročnega vpliva na plodnost po zdravljenju z bosentanom ni mogoče izključiti.
English: • inform patients of the need to avoid pregnancy and to ensure effective contraceptive measures are used.
Slovenian: • obveščanje bolnikov o potrebi preprečitve zanositve in o zagotavljanju uporabe zanesljivih načinov kontracepcije.
English: In the FUTURE 1 study, the median exposure to study treatment was 13.1 weeks (range: 8.4 to 21.1).
Slovenian: V študiji FUTURE 1 je bila mediana izpostavljenost raziskovanemu zdravljenju 13,1 tednov (razpon: 8,4 do 21,1).
English: Other antiretroviral agents: No specific recommendation can be made with regard to other available antiretroviral agents due to the lack of data.
Slovenian: Druga antiretrovirusna zdravila: Zaradi pomanjkanja podatkov ni specifičnih priporočil glede drugih antiretrovirusnih zdravil, ki so na voljo.
English: ((Inside 2))
Slovenian: ((Znotraj 2))
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min), plasma concentrations of bosentan decreased by approximately 10%.
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem ledvic (očistek kreatinina 15-30 ml/min) so se plazemske koncentracije bosentana znižale za približno 10 %.
English: At the same timepoints, 88% and 79% of patients remained free from PAH worsening (defined as all-cause death, lung transplantation, atrial septostomy or start of intravenous or subcutaneous prostanoid treatment).
Slovenian: V istih časovnih točkah ni prišlo do poslabšanja PAH pri 88 % in 79 % bolnikov (opredeljenega kot smrt zaradi vseh razlogov, presaditev pljuč, atrijska septostomija ali začetek intravenskega ali subkutanega prostanoidnega zdravljenja).
English: Limited data in patients show that the exposure to bosentan in adult PAH patients is approximately 2-fold greater than in healthy adult subjects.
Slovenian: Omejeni podatki, ki so na voljo za bolnike, kažejo, da je izpostavljenost bosentanu pri odraslih bolnikih s PAH približno 2-krat večja kot pri zdravih odraslih.
English: At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study.
Slovenian: Ob vstopu v študijo so bili bolniki zdravljeni z zdravili za PAH (najpogosteje samo z zaviralcem fosfodiesteraze tipa 5 [sildenafil] [35,9 %], samo bosentanom [10,9 %] in s kombinacijo bosentana, iloprosta in sildenafila [10,9 %] ter so nadaljevali s svojim zdravljenjem PAH med trajanjem študije.
English: The dose recommendation in children is only for PAH.
Slovenian: Priporočeni odmerek za otroke velja le za zdravljenje PAH.
English: Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.
Slovenian: Bosentan je dvojni antagonist endotelinskih receptorjev (ERA - Endothelin Receptor Antagonist) z afiniteto za endotelinske receptorje A in B (ETA in ETB).
English: 9 patients were newly initiated on PAH-specific medication during the study.
Slovenian: 9 bolnikov je na novo začelo dobivati za PAH specifično zdravilo med trajanjem študije.
English: Uncontrolled clinical studies in paediatric patients
Slovenian: Pediatrična populacija Nenadzorovane klinične študije pri pediatričnih bolnikih
English: Liver enzyme changes typically occur within the first 26 weeks of treatment but may also occur late in treatment (see section 4.8).
Slovenian: Spremembe koncentracij jetrnih encimov se običajno pojavijo v prvih 26 tednih zdravljenja, lahko pa se pojavijo tudi pozneje med zdravljenjem (glejte poglavje 4.8).
English: However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered.
Slovenian: Da preprečimo možno škodljivo poslabšanje kliničnega stanja zaradi možnega učinka ponovnega pojava bolezenskega stanja, odmerek nižamo postopoma (razpolavljanje odmerka 3 do 7 dni).
English: • pain in your stomach (abdomen)
Slovenian: • bolečine v želodcu (trebuhu)
English: These increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction.
Slovenian: Ta povišanja so delno lahko posledica kompetitivne inhibicije izločanja žolčnih soli iz hepatocitov, vendar so pri okvarjenem delovanju jeter verjetno vpleteni tudi drugi, za sedaj še ne popolnoma razjasnjeni mehanizmi.
English: STAYVEER should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Slovenian: Zdravljenje z zdravilom STAYVEER lahko uvedemo le, če je sistolični krvni tlak višji od 85 mm Hg.
English: Overall, 78% of patients remained in WHO functional class II.
Slovenian: Na splošno je 78 % bolnikov ostalo v II.
English: Massive overdose may result in pronounced hypotension requiring active cardiovascular support.
Slovenian: Zelo veliko preveliko odmerjanje lahko povzroči izrazito hipotenzijo, pri kateri so potrebni aktivni srčnožilni podporni ukrepi.
English: Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Slovenian: Zato morate, če uporabljate hormonsko kontracepcijo, uporabiti tudi pregradno metodo (npr. ženski kondom, diafragmo, kontracepcijsko spužvo ali pa mora vaš partner uporabiti tudi kondom).
English: The tablets can be taken with or without food.
Slovenian: Tablete lahko vzamete s hrano ali brez nje.
English: Moreover, if you are suffering from pulmonary hypertension disease, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Slovenian: Če imate pljučno hipertenzijo, lahko nosečnost hudo poslabša simptome vaše bolezni.
English: Bosentan specifically antagonises ET receptors and does not bind to other receptors.
Slovenian: Bosentan je specifični antagonist receptorjev ET in se na druge receptorje ne veže.
English: Re-introduction of treatment with STAYVEER should only be considered if the potential benefits of treatment with STAYVEER outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Slovenian: Ponovna uvedba zdravljenja z zdravilom STAYVEER pride v poštev le, če so potencialne koristi zdravljenja z zdravilom STAYVEER večje kot potencialno tveganje in so ravni jetrnih aminotransferaz v okviru vrednosti pred zdravljenjem.
English: Tell your doctor immediately if you become pregnant while you are taking STAYVEER, or plan to become pregnant in the near future.
Slovenian: Svojemu zdravniku takoj povejte, če v času jemanja zdravila STAYVEER zanosite ali če načrtujete zanositev v bližnji prihodnosti.
English: Steady-state conditions are reached within 3-5 days.
Slovenian: Stanje dinamičnega ravnovesja se vzpostavi v 3-5 dneh.
English: ((Inside 1))
Slovenian: ((Znotraj 1))
English: • Syncope (fainting)
Slovenian: • sinkopa (omedlevanje)
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with STAYVEER
Slovenian: • hormonski kontraceptivi ne smejo biti edini način kontracepcije med zdravljenjem z zdravilom
English: In placebo-controlled studies, bosentan-related decreases in haemoglobin concentration were not progressive, and stabilised after the first 4-12 weeks of treatment.
Slovenian: V študijah, nadziranih s placebom, z bosentanom povezana znižanja koncentracije hemoglobina niso napredovala in so se po prvih 4-12 tednih zdravljenja ustalila.
English: Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Slovenian: Ravni aminotransferaz moramo preveriti v 3 dneh po ponovni uvedbi zdravljenja, nato še enkrat po dveh tednih in kasneje v skladu z zgornjimi priporočili.
English: There was one hospitalisation related to PAH worsening in the bosentan group and three hospitalisations in the placebo group.
Slovenian: V zvezi s poslabšanjem PAH je bila hospitalizirana ena oseba iz skupine z bosentanom in tri osebe iz skupine s placebom.
English: The Kaplan-Meier estimate of overall survival at 2 years was 91.2%.
Slovenian: Po Kaplan-Meierjevem izračunu je bilo skupno preživetje po 2 letih 91,2 %.
English: The effect of bosentan on mitochondrial function is unknown.
Slovenian: Učinek bosentana na delovanje mitohondrijev ni znan.
English: Bosentan was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen and digoxin, but not epoprostenol.
Slovenian: Bosentan so dodali k tedanji terapiji bolnikov, ki je lahko vključevala kombinacijo antikoagulantov, vazodilatatorjev (denimo, zaviralcev kalcijevih kanalčkov), diuretike, kisik in digoksin, ne pa epoprostenola.
English: • Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4)
Slovenian: • izhodiščne vrednosti jetrnih aminotransferaz, tj. aspartat-aminotransferaze (AST) in/ali alanin aminotransferaze (ALT), več kot 3 × višje od zgornje meje normalnih vrednosti (ZMN; glejte poglavje 4.4)
English: Pulmonary arterial hypertension associated with HIV infection
Slovenian: Pljučna arterijska hipertenzija, povezana z okužbo s HIV
English: For all these tests please refer also to the Patient Alert Card (inside your pack of STAYVEER tablets).
Slovenian: Za te preiskave glejte tudi Opozorilno kartico za bolnika (v škatli s tabletami zdravila STAYVEER).
English: This decrease is probably due to auto-induction of metabolising liver enzymes.
Slovenian: To znižanje je verjetno posledica samoindukcije presnavljajočih encimov v jetrih.
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and
Slovenian: V skupni analizi 100 otrok s PAH iz nenadzorovanih pediatričnih študij FUTURE 1/2
English: The primary endpoint for each study was change in 6-minute walk distance at 12 weeks for the first study and 16 weeks for the second study.
Slovenian: Primarni opazovani dogodek obeh študij je bila sprememba v prehojeni razdalji v 6 minutah hoje po 12. tednu v prvi študiji in po 16. tednu v drugi študiji.
English: Animal studies showed testicular effects (see section 5.3).
Slovenian: Študije pri živalih so pokazale učinke na testise (glejte poglavje 5.3).