FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative risk reduction (99% CI)
Slovenian: Zmanjšanje relativnega tveganja (99-% IZ)
English: Taking other medicines may affect how Uptravi works.
Slovenian: Jemanje drugih zdravil lahko vpliva na način delovanja zdravila Uptravi.
English: Except for the active metabolite, none of the circulating metabolites in human plasma exceed 3% of the total drug-related material.
Slovenian: Razen aktivnega presnovka ne preseže noben od presnovkov, ki krožijo v plazmi pri človeku, 3 % celotne snovi, povezane z zdravilom.
English: 7.5% of patients on selexipag discontinued treatment due to these adverse reactions.
Slovenian: 7,5 % bolnikov na seleksipagu se je zaradi neželenih učinkov prenehalo zdraviti.
English: Uptravi is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension, also called PAH.
Slovenian: Zdravilo Uptravi se jemlje vsako jutro in vsak večer za zdravljenje pljučne arterijske hipertenzije, imenovane tudi PAH.
English: The beneficial effect of selexipag was primarily attributable to a reduction in hospitalisation for PAH and a reduction in other disease-progression events (Table 1).
Slovenian: Koristni učinek seleksipaga primarno pripisujejo zmanjšanju hospitalizacije zaradi PAH in zmanjšanju drugih dogodkov napredovanja bolezni (preglednica 1).
English: The numerical increase in deaths up to end of treatment + 7 days but not up to study closure was further investigated by mathematical modelling, showing that the imbalance in deaths is consistent with the assumption of a neutral effect on PAH mortality and reduction of non-fatal events.
Slovenian: Numerično povečanje smrti do konca zdravljenja + 7 dni, vendar ne do konca zaprtja študije, je bilo nadalje preučeno z matematičnim modeliranjem, in kaže, da je nesorazmernost smrti konsistentna z domnevo o nevtralnem učinku na smrtnost zaradi PAH in zmanjšanje ne-smrtnih primerov.
English: Transporter inhibitors (lopinavir/ritonavir)
Slovenian: Zaviralci prenašalca (lopinavir/ritonavir)
English: Isolated cases of overdose up to 3,200 micrograms were reported.
Slovenian: Poročali so o posamičnih primerih prevelikega odmerjanja z do 3.200 mikrogrami.
English: Selexipag (N=574)
Slovenian: Seleksipag (N = 574)
English: Selexipag and the active metabolite are not genotoxic on the basis of the overall evidence of conducted genotoxicity studies.
Slovenian: Seleksipag in njegov aktivni presnovek nista genotoksična na podlagi vseh dokazov izvedenih študij genotoksičnosti.
English: Time to PAH-related death or hospitalisation for PAH was assessed as a secondary endpoint.
Slovenian: Čas do smrti, povezane s PAH, ali hospitalizacije zaradi PAH so ocenili kot sekundarni opazovani dogodek.
English: PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
Slovenian: PAH pomeni visok krvni tlak znotraj krvnih žil, ki prenašajo kri iz srca v pljuča (pljučnih arterij).
English: Animal studies indicated an increased risk of intussusception, but the clinical relevance of these findings is unknown (see section 5.3).
Slovenian: Študije na živalih kažejo povečano tveganje invaginacije, vendar klinični pomen teh izsledkov ni znan (glejte poglavje 5.3).
English: Take the tablets with meals as you might tolerate your medicine better.
Slovenian: Tablete jemljite z obroki, saj boste morda zdravilo bolje prenašali.
English: This makes it easier for the heart to pump blood through the pulmonary arteries.
Slovenian: S tem srcu olajšajo črpanje krvi skozi pljučne arterije.
English: Remember to record the number of tablets you take every day in your titration diary.
Slovenian: Ne pozabite zapisati števila tablet, ki jih vsak dan vzamete, v svoj dnevnik titriranja.
English: Others may reach a maintenance dose somewhere inbetween.
Slovenian: Pri ostalih je vzdrževalni odmerek nekje vmes.
English: This process is called titration.
Slovenian: Ta postopek se imenuje titriranje.
English: The volume of distribution of selexipag at steady state is 11.7 L.
Slovenian: Volumen porazdelitve seleksipaga v stanju dinamičnega ravnovesja je 11,7 l.
English: Every patient with PAH is different.
Slovenian: Bolniki s PAH se med seboj razlikujejo.
English: Death up to EOT + 7 daysd n (%)
Slovenian: Smrt do EOT + 7 dnid n (%)
English: • Diary to facilitate Uptravi use and serve as a reminder for the patients (e.g., to contact her/his doctor), and a place to record intake of tablets;
Slovenian: • dnevnik, ki olajša uporabo zdravila Uptravi in služi bolnikom kot opomnik (tj. za vzpostavitev stika z bolnikovim zdravnikom) in kot prostor za beleženje jemanja tablet;
English: The missed dose should not be taken if the next scheduled dose is within approximately 6 hours.
Slovenian: Bolnik izpuščenega odmerka ne sme vzeti, če je naslednji odmerek predviden v roku približno 6 ur.
English: Uptravi 200 microgram
Slovenian: Uptravi 200 mikrogramov
English: Additional histopathological findings of selexipag were observed only at exposures sufficiently in excess of the maximum human exposure, indicating little relevance to humans.
Slovenian: Dodatne histopatološke izsledke seleksipaga so opazili le pri izpostavljenostih, ki so veliko večje od največje izpostavljenosti pri ljudeh, kar kaže na majhen pomen za ljudi.
English: Coagulation factors
Slovenian: Koagulacijski faktorji
English: They are usually transient or manageable with symptomatic treatment (see section 4.8).
Slovenian: Običajno so prehodni in obvladljivi s simptomatskim zdravljenjem (glejte poglavje 4.8).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Uptravi in one or more subsets of the paediatric population for treatment of pulmonary hypertension, (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Uptravi za eno ali več podskupin pediatrične populacije za zdravljenje pljučne hipertenzije, (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What Uptravi is and what it is used for What you need to know before you take Uptravi How to take Uptravi
Slovenian: Kaj je zdravilo Uptravi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Uptravi Kako jemati zdravilo Uptravi
English: There are no data from the use of selexipag in pregnant women.
Slovenian: Podatkov o uporabi seleksipaga pri nosečnicah ni.
English: The film-coated tablets are to be taken orally in the morning and in the evening.
Slovenian: Filmsko obložene tablete se jemljejo peroralno zjutraj in zvečer.
English: Selectivity against EP2, EP4, and DP1 is important because these receptors mediate immune depressive effects.
Slovenian: Selektivnost proti EP2, EP4 in DP1 je pomembna, ker ti receptorji posredujejo pri imunskih depresivnih učinkih.
English: The active metabolite is a weak substrate of the breast cancer resistance protein (BCRP).
Slovenian: Aktivni presnovek je šibek substrat proteina odpornosti pri raku dojke (BCRP-breast cancer resistance protein).
English: Administration of selexipag in the paediatric population is not recommended.
Slovenian: Dajanje seleksipaga pediatrični populaciji se ne priporoča.
English: This may cause people to feel tired, dizzy, short of breath, or experience other symptoms.
Slovenian: Zaradi tega se bolniki lahko počutijo utrujene, omotične, zasople ali imajo druge simptome.
English: The MAH shall ensure that in each Member State where Uptravi is marketed, all healthcare professionals who are expected to prescribe and/or dispense Uptravi are provided with a Prescriber Kit containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Uptravi trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo Uptravi predpisovali in/ali izdajali, prejeli komplet izobraževalnih gradiv za zdravnike, ki zdravilo predpisujejo, ki vsebuje naslednje:
English: CI = confidence interval; EOT = end of treatment; HR = hazard ratio; i.v.
Slovenian: IZ = interval zaupanja; EOT (end of treatment) = konec zdravljenja; RT = razmerje tveganja; i.v.
English: Other medicines and Uptravi
Slovenian: Druga zdravila in zdravilo Uptravi
English: Write down your doctor or nurse's instructions:
Slovenian: Zabeležite si navodila zdravnika ali medicinske sestre:
English: This is called titration.
Slovenian: To se imenuje titriranje.
English: It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen.
Slovenian: Deluje na krvne žile na podoben način kot naravna snov prostaciklin, tako da jih sprosti in razširi.
English: All events were confirmed by an independent adjudication committee, blinded to treatment allocation.
Slovenian: Vse dogodke je potrdil neodvisni presojevalni odbor, ki ni poznal oblike zdravljenja bolnika.
English: • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Slovenian: • Prirojena ali pridobljena okvara zaklopke s klinično pomembno disfunkcijo miokarda, nepovezana s pljučno hipertenzijo.
English: The Controlled Access System is aimed to facilitate the identification of prescribers, to approach them with the appropriate information on the safe and effective use of Uptravi, and to provide them with risk minimisation tools, especially regarding the potential risk of medication error.
Slovenian: Sistem nadzorovanega dostopa olajša identifikacijo zdravnikov, ki zdravilo predpisujejo in omogoča, da se seznanijo z ustreznimi informacijami o varni in učinkoviti uporabi zdravila Uptravi in ukrepi za zmanjševanje tveganj, zlasti glede možnih napak pri uporabi zdravila.
English: • The identification and maintenance of a list of all Uptravi prescribers;
Slovenian: • identifikacija in vzdrževanje seznama vseh zdravnikov, ki zdravilo Uptravi predpisujejo;
English: However, if the decision to withdraw Uptravi is taken, it should be done gradually while an alternative therapy is introduced.
Slovenian: Pri odločitvi za prenehanje uporabe zdravila Uptravi mora to potekati postopoma, ob uvajanju alternativnega zdravljenja.
English: When you move to your maintenance dose.............14
Slovenian: Ko preidete na vzdrževalni odmerek ..........14
English: Doctor's office telephone and e-mail:
Slovenian: Telefon ali e-pošta zdravnikove ordinacije:
English: * See section Description of selected adverse reactions.
Slovenian: * Glejte opis izbranih neželenih učinkov.
English: You will start at the 200 microgram dose in the morning and in the evening and after discussing with your doctor or nurse step up to the next dose.
Slovenian: Začeli boste z 200-mikrogramskim odmerkom zjutraj in zvečer, po pogovoru z zdravnikom ali medicinsko sestro pa boste odmerek povečali za en korak.
English: TITRATION GUIDE - TITRATION PACK Page 1
Slovenian: NAVODILA ZA TITRIRANJE - TITRACIJSKO PAKIRANJE 1. stran
English: Hospitalisation due to PAH b n (%)
Slovenian: Hospitalizacija zaradi PAH b n (%)
English: In the 2-year carcinogenicity studies, selexipag caused an increased incidence of thyroid adenomas in mice and Leydig cell adenomas in rats.
Slovenian: V 2-letnih študijah kancerogenosti je seleksipag povzroči večjo incidenco adenomov ščitnice pri miših in adenomov Leydigovih celic pri podganah.
English: The majority of these reactions are of mild to moderate intensity.
Slovenian: Intenzivnost teh reakcij je večinoma blaga do zmerna.
English: This is called the maintenance dose.
Slovenian: To se imenuje vzdrževalni odmerek.
English: Therefore, safety margins for potential IP receptor-mediated effects on reproduction are accordingly lower than for non-IP-related effects (see section 5.3).
Slovenian: Zato so varnostne meje za možne učinke na sposobnost razmnoževanja, pri katerih posreduje receptor IP, manjše kot za učinke, ki niso povezani z IP (glejte poglavje 5.3).
English: Pulmonary veno-occlusive disease
Slovenian: Pljučna vensko-okluzivna bolezen
English: This is most probably due to a first-pass effect of selexipag, as plasma concentrations of the active metabolite are similar after the same oral and intravenous dose administration.
Slovenian: Najverjetneje je to posledica presnove prvega prehoda seleksipaga, saj so koncentracije aktivnega presnovka v plazmi po enakem peroralnem in intravenskem odmerku podobne.
English: There are 2 phases of treatment with Uptravi:
Slovenian: Zdravljenje z zdravilom Uptravi poteka v 2 fazah:
English: Contents of the pack and other information What Uptravi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Uptravi
English: • The distribution of kits to all identified prescribers to minimise the risks of medication error in particular;
Slovenian: • razdeljevanje kompletov izobraževalnih gradiv vsem identificiranim zdravnikom, ki zdravilo predpisujejo, zlasti zaradi zmanjšanja tveganja napak pri uporabi zdravila;
English: • Severe arrhythmias.
Slovenian: • Hude aritmije.
English: There was no significant treatment effect from baseline to Week 26.
Slovenian: Značilnih učinkov zdravljenja od izhodišča do 26. tedna ni bilo.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC27
Slovenian: Farmakoterapevtska skupina: antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC27
English: Individualised maintenance dose
Slovenian: Individualizirani vzdrževalni odmerek
English: However, if a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level.
Slovenian: Če bolnik doseže odmerek, ki ga ne prenaša več, je treba odmerek zmanjšati na prejšnjo raven.
English: Tell your doctor if you are taking other medications as your doctor may recommend that you take Uptravi only once daily.
Slovenian: Zdravniku povejte, če jemljete kakšna druga zdravila, saj lahko zdravnik priporoči, da jemljete zdravilo Uptravi samo enkrat na dan.
English: When you move to your maintenance dose
Slovenian: Ko preidete na vzdrževalni odmerek
English: Selexipag and its active metabolite are highly bound to plasma proteins (approximately 99% in total and to the same extent to albumin and alpha1-acid glycoprotein).
Slovenian: Seleksipag in njegov aktivni presnovek se v visoki meri vežeta na beljakovine v plazmi (skupaj približno 99 %, v enaki meri na albumin in na kisli alfa-1-glikoprotein.
English: Selexipag did not influence the pharmacodynamic effect of warfarin on the international normalised ratio.
Slovenian: Seleksipag ni vplival na farmakodinamični učinek varfarina na mednarodno normalizirano razmerje.
English: There is limited experience with Uptravi in patients older than 75 years.
Slovenian: Izkušnje z zdravilom Uptravi pri bolnikih, starejših od 75 let, so omejene.
English: Selexipag and the active metabolite are high-affinity IP receptor agonists with a high selectivity for the IP receptor versus other prostanoid receptors (EP1-EP4, DP, FP, and TP).
Slovenian: Seleksipag in aktivni presnovek imata veliko afiniteto za agoniste receptorja IP z veliko selektivnostjo za receptorje IP v primerjavi z drugimi receptorji prostanoidov (EP1-EP4, DP, FP in TP).
English: Selexipag and its active metabolite do not inhibit or induce cytochrome P450 enzymes and transport proteins at clinically relevant concentrations.
Slovenian: Seleksipag in njegov aktivni presnovek ne zavirata ali inducirata encimov citokroma P450 in transportnih beljakovin v klinično pomembnih koncentracijah.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Slovenian: Zdravljenje mora uvesti in nadzirati le zdravnik z izkušnjami pri zdravljenju PAH.
English: How should you step up your dose?
Slovenian: Kako povečevati odmerek?
English: Your maintenance dose is the dose you should continue to take on a regular basis.
Slovenian: Vaš vzdrževalni odmerek je odmerek, ki ga boste jemali redno.
English: It could take several weeks to find the dose that is right for you.
Slovenian: trajalo več tednov, da boste našli odmerek, ki vam ustreza.
English: Death up to study closure d n (%)
Slovenian: Smrt do zaprtja študije d n (%)
English: • The Summary of Product Characteristics for Uptravi;
Slovenian: • povzetek glavnih značilnosti zdravila Uptravi;
English: No adjustment to the dose regimen is needed in elderly people (see section 5.2).
Slovenian: Pri starejših ljudeh režima odmerjanja ni treba prilagajati (glejte poglavje 5.2).
English: Uncommon (≥ 1/1,000 to < 1/100)
Slovenian: (≥ 1/1.000 do < 1/100)
English: If, at any time, after taking the same dose for a long time, you experience side effects that you cannot tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced.
Slovenian: Če kadar koli po daljšem jemanju enakega odmerka doživite neželene učinke, ki jih ne morete prenašati, ali neželene učinke, ki vplivajo na vaše običajne vsakodnevne dejavnosti, se posvetujte z zdravnikom, saj bo morda treba odmerek zmanjšati.
English: Prior to the launch of Uptravi in each Member State, the MAH must agree on the content and format of the Controlled Access System with the National Competent Authority.
Slovenian: Pred prihodom zdravila Uptravi na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki sistema nadzorovanega dostopa.
English: Increased bone ossification and related changes in the bone marrow in dog studies are considered to be due to the activation of EP4 receptors in dogs.
Slovenian: Velja, da je večja osifikacija kosti in povezane spremembe kostnega mozga pri študijah na psih posledica aktivacije receptorjev EP4 pri psih.
English: If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them.
Slovenian: Če te neželene učinke težko prenašate, se z zdravnikom posvetujte, kako se lahko obvladajo ali zdravijo.
English: Once your doctor has found the dose that is right for you, this will be the dose you take on a regular basis.
Slovenian: Ko zdravnik ugotovi, kateri odmerek je za vas primeren, boste ta odmerek jemali redno.
English: Selexipag and its active metabolite are substrates of OATP1B1 and OATP1B3.
Slovenian: Seleksipag in njegov aktivni presnovek sta substrata OATP1B1 in OATP1B3.
English: After multiple-dose administration, steady state conditions of selexipag and the active metabolite were reached within 3 days.
Slovenian: Po dajanju večkratnih odmerkov je bilo stanje dinamičnega ravnovesja seleksipaga in aktivnega presnovka doseženo v 3 dneh.
English: If you forget to take Uptravi
Slovenian: Če ste pozabili vzeti zdravilo Uptravi
English: The overall median double-blind treatment duration was 63.7 weeks for the placebo group and 70.7 weeks for the selexipag group.
Slovenian: Celokupno mediano trajanje dvojno slepega zdravljenja je bilo 63,7 tednov za skupino s placebom in 70,7 tednov za skupino s seleksipagom.
English: At the beginning of treatment and at each up-titration step it is recommended to take the first dose in the evening.
Slovenian: Na začetku zdravljenja in ob vsakem koraku večanja odmerka se priporoča jemanje prvega odmerka zvečer.
English: In the first several weeks, you will work with your doctor to find the dose of Uptravi that is right for you.
Slovenian: Prvih nekaj tednov boste sodelovali z zdravnikom, ki bo določil primeren odmerek zdravila Uptravi za vas.
English: There were no mean changes in triiodothyronine or thyroxine in either group.
Slovenian: V skupini s trijodotironinom ali tiroksinom ni bilo povprečnih sprememb.
English: Given the 37-fold higher potency of the active metabolite, this effect is not clinically relevant.
Slovenian: Glede na 37-krat večjo jakost aktivnega presnovka ta učinek ni klinično relevanten.
English: The diagram below shows stepping down to a lower dose.
Slovenian: Spodnji diagram prikazuje korak zmanjševanja odmerka.
English: The healthcare professional A4 laminated titration guide is intended to reduce the risk of medication error due to the titration phase at treatment initiation with Uptravi and it should contain the following key elements:
Slovenian: Laminirano navodilo za titriranje zdravila velikosti A4 za zdravstvene delavce se uporablja za zmanjševanje napak pri uporabi zdravila zaradi faze titriranja ob začetku zdravljenja z zdravilom Uptravi in mora vsebovati naslednje ključne elemente:
English: If you have been prescribed both 200 and 800 microgram tablets, use pages 30 to 37 (steps 5-8).
Slovenian: 800-mikrogramske tablete, uporabite strani 30 do 37 (koraki 5-8).
English: In the repeated-dose toxicity studies in rodents, strong blood pressure decrease as a result of exaggerated pharmacology induced transient clinical signs and reduced food consumption and body-weight gain.
Slovenian: Študije toksičnosti pri ponavljajočih odmerkih pri glodalcih so pokazale močno zmanjšanje krvnega tlaka kot posledica pretiranih farmakološko izzvanih prehodnih kliničnih znakov in zmanjšanega vnosa hrane ter pridobivanja telesne mase.
English: Mechanistically, the effect is considered to be induced by life-long vasodilation and subsequent changes in ocular haemodynamics.
Slovenian: Mehanično velja, da učinek izzove vazodilatacija, ki traja vse življenje, in posledične spremembe okularne hemodinamike.
English: Uptravi has vasodilatory properties that may result in lowering of blood pressure.
Slovenian: Zdravilo Uptravi ima vazodilatorne lastnosti, ki lahko povzročijo znižanje krvnega tlaka.
English: Selexipag prevents cardiac and pulmonary remodelling in a rat model of PAH and causes proportional decreases in pulmonary and peripheral pressures, indicating that peripheral vasodilation reflects pulmonary pharmacodynamic efficacy.
Slovenian: Seleksipag v podganjem modelu PAH preprečuje srčno in pljučno remodeliranje in povzroča sorazmerno zmanjšanje pljučnih in perifernih tlakov, kar kaže, da periferna vazodilatacija odraža pljučni farmakodinamični učinek.
English: Do not stop taking Uptravi unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Uptravi, razen če vam to naroči vaš zdravnik.
English: The highest dose that you can tolerate during titration will become your maintenance dose.
Slovenian: Največji odmerek, ki ga lahko med titracijo prenašate, bo postal vaš vzdrževalni odmerek.
English: A no-observed-adverse-effect level was not established.
Slovenian: Ravni brez vidnega neželenega učinka niso določili.
English: Treatment should be initiated in the evening.
Slovenian: Z zdravljenjem začnite zvečer.
English: It is unknown whether selexipag or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se seleksipag ali njegovi presnovki izločajo v materino mleko.
English: Since a strong inhibitor of CYP3A4 did not affect the pharmacokinetics of the active metabolite, indicating that the CYP3A4 pathway is not important in the elimination of the active metabolite, no effect of inducers of CYP3A4 on the pharmacokinetics of the active metabolite is expected.
Slovenian: Ker močni zaviralec CYP3A4 ni vplival na farmakokinetiko aktivnega presnovka, kar kaže, da pot CYP3A4 ni pomembna za izločanje aktivnega presnovka, se učinkov induktorjev CYP3A4 na farmakokinetiko aktivnega presnovka ne pričakuje.
English: In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them.
Slovenian: Pri bolnikih s PAH se te arterije zožijo, zato mora srce več delati, da skoznje načrpa kri.
English: • Decompensated cardiac failure if not under close medical supervision.
Slovenian: • Dekompenzirana srčna odpoved, ki ni pod skrbnim zdravniškim nadzorom.
English: A potential pharmacokinetic interaction with strong inhibitors of UGT1A3 and UGT2B7 cannot be excluded.
Slovenian: Možnega farmakokinetičnega medsebojnega delovanja z močnimi zaviralci UGT1A3 in UGT2B7 ni možno izključiti.