FrancophonIA/ELRC3.0 huggingface dataset:
English: Please see section Maintenance dose below for more information.
Slovak: Ďalšie informácie pozri v časti Udržiavacia dávka.
English: Page 13
Slovak: Strana 13
English: The mean treatment duration was 76.4 weeks (median 70.7 weeks) for patients receiving selexipag versus 71.2 weeks (median 63.7 weeks) for patients on placebo.
Slovak: v skupine pacientov užívajúcich selexipag a 71,2 týždňa (medián 63,7 týždňa) v placebovej skupine.
English: A 1.4- to 1.7-fold increase in exposure (maximum plasma concentration and area under the plasma concentration-time curve) to selexipag and its active metabolite was observed in subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Slovak: U subjektov s ťažkou poruchou funkcie obličiek (eGFR < 30 ml/min/1,73 m2) bol pozorovaný 1,4- až 1,7-násobný nárast expozície (maximálna koncentrácia v plazme a plocha pod časovou krivkou koncentrácie) selexipagu a jeho aktívnemu metabolitu.
English: The primary study endpoint was the time to first occurrence of a morbidity or mortality event up to end of treatment, defined as a composite of death (all causes); or hospitalisation for PAH; or progression of PAH resulting in need for lung transplantation or balloon atrial septostomy; or initiation of parenteral prostanoid therapy or chronic oxygen therapy; or other disease-progression events (patients in WHO FC II or III at baseline) confirmed by a decrease in 6-minute walk distance (6MWD) from baseline (≥ 15%) and worsening of WHO FC or (patients in WHO FC III or IV at baseline) confirmed by a decrease in 6MWD from baseline (≥ 15%) and need for additional
Slovak: PAH, alebo progresia PAH s potrebou transplantácie pľúc alebo balónkovej atriálnej septostómie, alebo nasadenie parenterálnej prostanoidnej liečby alebo dlhodobej oxygenoterapie, alebo progresia ochorenia pre iné príčiny (pacienti v II. alebo III. funkčnej triede podľa WHO na začiatku) potvrdená poklesom v 6-minútovom teste chôdzou v porovnaní so vstupnou hodnotou (≥
English: Page 11
Slovak: Strana 11
English: Hypromellose, propylene glycol, titanium dioxide (E171), carnauba wax and iron oxides (see below).
Slovak: v obale tablety: hypromelóza, propylénglykol, oxid titaničitý (E171), karnaubský vosk a oxidy železité (pozri nižšie).
English: • Cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
Slovak: Mozgovocievne príhody (napr. prechodný ischemický záchvat, mozgová porážka) za posledné
English: Page 7
Slovak: Strana 7
English: Page 3
Slovak: Strana 3
English: Page 27
Slovak: Strana 27
English: Page 32
Slovak: Strana 32
English: Page 14
Slovak: Strana 14
English: Diarrhoea* Vomiting * Nausea*
Slovak: Bolesť kĺbov* Bolesť končatín*
English: Hospitalisation for PAH was observed in 86 (15.0%) patients on selexipag and 123 (21.1%) patients on placebo.
Slovak: %) pacientov na selexipagu a u 123 (21,1
English: In a thorough QT study in healthy subjects, repeated doses of 800 and 1,600 micrograms of selexipag twice daily did not show an effect on cardiac repolarisation (QTc interval) or conduction (PR and QRS intervals) and had a mild accelerating effect on heart rate (the placebo-corrected, baseline-adjusted increase in heart rate reached 6-7 bpm at 1.5 to 3 h after dosing with 800 micrograms selexipag and 9-10 bpm at the same timepoints after 1,600 micrograms selexipag).
Slovak: (intervaly PR a QRS) a mali mierny akceleračný účinok na pulzovú frekvenciu (zvýšenie pulzovej frekvencie, korigované placebom, porovnávané so vstupnými hodnotami, bolo 6 - 7 úderov/min po 1,5 až 3 h od podania dávky 800 mikrogramov selexipagu a 9 - 10 úderov/min v rovnakých časových bodoch po 1 600 mikrogramoch selexipagu).
English: Hospitalisation due to PAH b n (%)
Slovak: PAHb n (%)
English: Treatment with selexipag resulted in a placebo-corrected median effect on 6MWD measured at trough (i.e., approximately 12 h post-dose) of 12 m at Week 26 (99% CI: 1, 24 m;
Slovak: j. približne 12 h po podaní dávky) 12 m v 26. týždni (99 % CI: 1,24 m; jednostranná p hodnota =
English: Page 4
Slovak: Strana 4
English: Page 6
Slovak: Strana 6
English: Only two subjects with severe (Child-Pugh class C) hepatic impairment were dosed with selexipag.
Slovak: Selexipag bol podávaný len dvom subjektom s ťažkou poruchou funkcie pečene (trieda C podľa Childa-Pugha).
English: Nasopharyngitis (of non-infectious origin)
Slovak: (neinfekčného pôvodu)
English: Titration Guide
Slovak: Príručka titrácie
English: The first intake of Uptravi should be in the evening.
Slovak: Prvá tableta Uptravi sa má užiť večer.
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Slovak: Ak teraz užívate alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi.
English: Flushing*
Slovak: Sčervenanie*
English: Anaemia Haemoglobin decreased
Slovak: Anémia Pokles hemoglobínu
English: Read the package leaflet and titration guide before use.
Slovak: Pred použitím si prečítajte písomnú informáciu pre používateľa a príručku titrácie.
English: If it is within 6 hours of when you would normally take your next dose, you should skip the missed dose and continue to take your medicine at the usual time.
Slovak: Pokiaľ však do užitia ďalšej dávky zostáva menej ako 6 hodín, vynechanú dávku preskočte a pokračujte v užívaní lieku vo zvyčajnom čase.
English: Actelion Pharmaceuticals Ltd.
Slovak: Janssen-Cilag Ltd.
English: During dose titration some adverse reactions, reflecting the mode of action of Uptravi (such as headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing), may occur.
Slovak: Počas titrácie dávky sa môžu vyskytnúť niektoré nežiaduce reakcie vyplývajúce z mechanizmu účinku Uptravi (napr. bolesť hlavy, hnačka, nevoľnosť a vracanie, bolesť čeľuste, bolesť svalov, bolesť končatín, bolesť kĺbov a sčervenanie).
English: Based on modelling and simulation data from a study in subjects with hepatic impairment, the exposure to selexipag at steady state in subjects with moderate hepatic impairment (Child-Pugh class B) after a once-daily regimen is predicted to be approximately 2-fold higher than that in healthy subjects during a twice-daily regimen.
Slovak: Na základe modelovaných a simulovaných údajov zo štúdie na subjektoch s poruchou funkcie pečene sa predpokladá, že expozícia selexipagu v rovnovážnom stave u subjektov so stredne ťažkou poruchou funkcie pečene (trieda
English: The percentages of patients with an event at Month 36 were 28.9% and 41.3% in the selexipag and placebo groups, respectively, with an absolute risk reduction of 12.4%.
Slovak: % v placebo skupine s absolútnou redukciou rizika 12,4
English: Page 22
Slovak: Strana 22
English: Pulmonary haemodynamics
Slovak: Pľúcna hemodynamika
English: No accumulation in plasma, either of parent compound or active metabolite, occurred after multiple-dose administration.
Slovak: Po podaní viacerých dávok nedošlo k akumulácii materskej zlúčeniny ani jej aktívneho metabolitu v plazme.
English: Talk to your PAH doctor or nurse if you are taking any of the following medicines: - Gemfibrozil (medicine used to lower the level of fats [lipids] in the blood) - Clopidogrel (medicine used to inhibit blood clots in coronary artery disease) - Deferasirox (medicine used to remove iron from the blood stream) - Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis) - Carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work) - Phenytoin (medicine used to treat epilepsy) - Valproic acid (medicine used to treat epilepsy) - Probenecid (medicine used to treat gout) - Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections)
Slovak: Oznámte svojmu pľúcnemu lekárovi alebo zdravotnej sestre, ak užívate niektoré z nasledujúcich liekov: - gemfibrozil (liek používaný na zníženie hladiny tukov (lipidov) v krvi), - klopidogrel (liek používaný na zabránenie tvorby krvných zrazenín pri ischemickej chorobe srdca (stav kedy krv nemôže prúdiť do srdca kvôli upchatiu ciev)),
English: Check with your doctor if you are not sure or have any questions.
Slovak: Ak si nie ste niečím istý alebo ak máte nejaké otázky, overte si to u svojho lekára.
English: Uptravi 200 microgram Uptravi 400 microgram Uptravi 600 microgram Uptravi 800 microgram Uptravi 1,000 microgram Uptravi 1,200 microgram Uptravi 1,400 microgram Uptravi 1,600 microgram
Slovak: Uptravi 1 000 mikrogramov Uptravi 1 200 mikrogramov Uptravi 1 400 mikrogramov Uptravi 1 600 mikrogramov
English: Prostacyclin-like associated adverse reactions
Slovak: Nežiaduce reakcie prostacyklínového typu
English: - The active substance is selexipag.
Slovak: násobne väčšou účinnosťou ako selexipag.
English: The total number of deaths of all causes up to study closure was 100 (17.4%) for the selexipag group and 105 (18.0%) for the placebo group (HR 0.97, 99% CI: 0.68, 1.39).
Slovak: %) v skupine na placebe (HR 0,97, 99 % CI: 0,68, 1, 39).
English: The exposure to selexipag and its active metabolite is increased in subjects with moderate hepatic impairment (Child-Pugh class B; see section 5.2).
Slovak: Expozícia selexipagu a jeho aktívnemu metabolitu sa zvyšuje u pacientov so stredne ťažkou poruchou funkcie pečene (trieda
English: This allows you to take one tablet in the morning and one in the evening, instead of multiple tablets each time.
Slovak: Vďaka tomu budete namiesto niekoľkých tabliet užívať jednu tabletu ráno a jednu večer.
English: doctor or nurse regularly during titration.
Slovak: Počas titrácie pravidelne informujte svojho pľúcneho lekára alebo zdravotnú sestru.
English: Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets Cartons of 60 film-coated tablets.
Slovak: Uptravi 400 mikrogramov, 600 mikrogramov, 800 mikrogramov, 1 000 mikrogramov, 1 200 mikrogramov, 1 400 mikrogramov a 1 600 mikrogramov filmom obalené tablety
English: There is no experience with Uptravi in patients undergoing dialysis (see section 5.2), therefore Uptravi should not be used in these patients.
Slovak: 5.2), preto sa Uptravi nemá u týchto pacientov používať.
English: Uptravi 800 microgram film-coated tablets: Round, green, film-coated tablets with “8” marked on one side.
Slovak: Uptravi 800 mikrogramov filmom obalené tablety: okrúhle zelené filmom obalené tablety s označením „8“ na jednej strane.
English: Selexipag and the active metabolite are not genotoxic on the basis of the overall evidence of conducted genotoxicity studies.
Slovak: Z celkových výsledkov uskutočnených štúdií genotoxicity vyplýva, že selexipag a jeho aktívny metabolit nie sú genotoxické.
English: Increase in heart rate
Slovak: - zvýšená srdcová frekvencia.
English: Uptravi 800 microgram film-coated tablets Each film-coated tablet contains 800 micrograms of selexipag.
Slovak: Uptravi 800 mikrogramov filmom obalené tablety obsahuje 800 mikrogramov selexipagu.
English: iron oxide red (E172), iron oxide black (E172), carnauba wax.
Slovak: červený oxid železitý (E172), karnaubský vosk.
English: Uptravi 200 microgram film-coated tablets Uptravi 400 microgram film-coated tablets Uptravi 600 microgram film-coated tablets Uptravi 800 microgram film-coated tablets Uptravi 1,000 microgram film-coated tablets Uptravi 1,200 microgram film-coated tablets Uptravi 1,400 microgram film-coated tablets Uptravi 1,600 microgram film-coated tablets selexipag
Slovak: Uptravi 200 mikrogramov filmom obalené tablety Uptravi 400 mikrogramov filmom obalené tablety Uptravi 600 mikrogramov filmom obalené tablety Uptravi 800 mikrogramov filmom obalené tablety Uptravi 1 000 mikrogramov filmom obalené tablety Uptravi 1 200 mikrogramov filmom obalené tablety Uptravi 1 400 mikrogramov filmom obalené tablety Uptravi 1 600 mikrogramov filmom obalené tablety selexipag
English: Patients titrating selexipag to an individually tolerated dose (200 micrograms twice daily increments up to 800 micrograms twice daily; N = 33) achieved a statistically significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI]: −44.7%, −12.2%; p = 0.0045) and an increase in cardiac index (mean treatment effect) of 0.48 L/min/m2 (95% CI: 0.13, 0.83) compared to placebo (N = 10).
Slovak: 0,0045) a zvýšenie kardiálneho indexu (priemerný účinok liečby) 0,48 l/min/m2 (95 % CI: 0,13; 0,83) v porovnaní s placebom (N =
English: Uptravi 200 microgram film-coated tablets Uptravi 400 microgram film-coated tablets Uptravi 600 microgram film-coated tablets Uptravi 800 microgram film-coated tablets Uptravi 1,000 microgram film-coated tablets Uptravi 1,200 microgram film-coated tablets Uptravi 1,400 microgram film-coated tablets Uptravi 1,600 microgram film-coated tablets
Slovak: Uptravi 200 mikrogramov filmom obalené tablety Uptravi 400 mikrogramov filmom obalené tablety Uptravi 600 mikrogramov filmom obalené tablety Uptravi 800 mikrogramov filmom obalené tablety Uptravi 1 000 mikrogramov filmom obalené tablety Uptravi 1 200 mikrogramov filmom obalené tablety Uptravi 1 400 mikrogramov filmom obalené tablety Uptravi 1 600 mikrogramov filmom obalené tablety
English: Uptravi 1,000 microgram film-coated tablets: Round, orange, film-coated tablets with “10” marked on one side.
Slovak: Uptravi 1 000 mikrogramov filmom obalené tablety: okrúhle oranžové filmom obalené tablety s označením „10“ na jednej strane.
English: Dosing frequency of Uptravi should be reverted to twice daily when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.2).
Slovak: Po ukončení súbežného podávania stredne silných inhibítorov CYP2C8 sa má dávkovanie Uptravi obnoviť na dvakrát denne (pozri časť 4.2).
English: Posology
Slovak: PRÍRUČKA
English: TITRATION GUIDE - TITRATION PACK Page 1
Slovak: TITRÁCIE - TITRAČNÉ BALENIE
English: Revert to twice daily dosing frequency of Uptravi when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.5).
Slovak: Po ukončení súbežného podávania stredne silných inhibítorov CYP2C8 obnovte dávkovanie Uptravi na dvakrát denne (pozri časť 4.5).
English: Uptravi 400 microgram film-coated tablets: Round, red, film-coated tablets with “4” marked on one side.
Slovak: Uptravi 400 mikrogramov filmom obalené tablety: okrúhle červené filmom obalené tablety s označením „4“ na jednej strane.
English: If the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram light-yellow tablets you take by one in the morning and by one in the evening.
Slovak: lekár môže upraviť dávku znížením počtu 200-mikrogramových svetložltých tabliet, ktoré užívate, o jednu ráno a o jednu večer.
English: Common side effects (may affect up to 1 in 10 people) - Anaemia (low red blood cell levels) - Hyperthyroidism (overactive thyroid gland) - Decreased appetite - Weight loss - Hypotension (low blood pressure) - Stomach pain - Pain - Changes in some blood test results including those measuring blood cell counts or your thyroid function - Rashes, including hives, may cause a burning or stinging sensation and skin redness
Slovak: Časté vedľajšie účinky (môžu postihnúť menej ako 1 z 10 osôb) - málokrvnosť (znížený počet červených krviniek), - hypertyreóza (zvýšená činnosť štítnej žľazy), - znížená chuť do jedla,
English: Uptravi 1,600 microgram film-coated tablets contain iron oxide black, iron oxide red and iron oxide yellow (E172).
Slovak: Uptravi 1 600 mikrogramov filmom obalené tablety obsahuje čierny oxid železitý, červený oxid železitý a žltý oxid železitý (E172).
English: Each film-coated tablet contains 200 micrograms of selexipag
Slovak: Každá filmom obalená tableta obsahuje 200 mikrogramov selexipagu.
English: Uptravi 1,600 microgram film-coated tablets: Round, brown, film-coated tablets with “16” marked on one side.
Slovak: Uptravi 1 600 mikrogramov filmom obalené tablety: okrúhle hnedé filmom obalené tablety s označením „16“ na jednej strane.
English: Uptravi 200 microgram film-coated tablets Each film-coated tablet contains 200 micrograms of selexipag.
Slovak: Uptravi 200 mikrogramov filmom obalené tablety obsahuje 200 mikrogramov selexipagu.
English: Round, light-violet, film-coated tablets with “6” debossed on one side.
Slovak: Okrúhle svetlofialové filmom obalené tablety s označením „6” na jednej strane.
English: Uptravi 200 microgram film-coated tablets contain iron oxide yellow (E172).
Slovak: Uptravi 200 mikrogramov filmom obalené tablety obsahuje žltý oxid železitý (E172).
English: Uptravi 800 microgram film-coated tablets contain iron oxide yellow and iron oxide black (E172).
Slovak: Uptravi 800 mikrogramov filmom obalené tablety obsahuje žltý oxid železitý a čierny oxid železitý (E172).
English: Uptravi 400 microgram film-coated tablets Each film-coated tablet contains 400 micrograms of selexipag.
Slovak: Uptravi 400 mikrogramov filmom obalené tablety obsahuje 400 mikrogramov selexipagu.
English: Uptravi 1,400 microgram film-coated tablets contain iron oxide yellow (E172).
Slovak: Uptravi 1 400 mikrogramov filmom obalené tablety obsahuje žltý oxid železitý (E172).
English: This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site:
Slovak: Táto písomná informácia bola naposledy aktualizovaná v
English: Uptravi 400 microgram film-coated tablets contain iron oxide red (E172).
Slovak: Uptravi 400 mikrogramov filmom obalené tablety obsahuje červený oxid železitý (E172).
English: Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein bound.
Slovak: Pre vysoký stupeň väzbovosti selexipagu a jeho aktívneho metabolitu na bielkoviny nie je pravdepodobné, že by dialýza bola účinná.
English: Uptravi 200 microgram film-coated tablets selexipag
Slovak: Uptravi 200 mikrogramov filmom obalené tablety selexipag
English: Uptravi 200 microgram film-coated tablets: Round, light-yellow, film-coated tablets with “2” marked on one side.
Slovak: Uptravi 200 mikrogramov filmom obalené tablety: okrúhle svetložlté filmom obalené tablety s označením „2“ na jednej strane.
English: Uptravi 1,200 microgram film-coated tablets Each film-coated tablet contains 1,200 micrograms of selexipag.
Slovak: Uptravi 1 200 mikrogramov filmom obalené tablety obsahuje 1 200 mikrogramov selexipagu.
English: Patients were randomised to either placebo (N = 582) or selexipag (N = 574) twice daily.
Slovak: (N = 582) alebo na selexipagu (N =
English: Uptravi 1,200 microgram film-coated tablets contain iron oxide black and iron oxide red (E172).
Slovak: Uptravi 1 200 mikrogramov filmom obalené tablety obsahuje čierny oxid železitý a červený oxid železitý (E172).
English: Uptravi 800 microgram film-coated tablet
Slovak: Uptravi 800 mikrogramov filmom obalené tablety
English: Uptravi 1,000 microgram film-coated tablets contain iron oxide red and iron oxide yellow (E172).
Slovak: Uptravi 1 000 mikrogramov filmom obalené tablety obsahuje červený oxid železitý a žltý oxid železitý (E172).
English: No evidence for acute rebound has been observed.
Slovak: Neboli zaznamenané žiadne akútne symptómy z vysadenia liečby.
English: Uptravi 600 microgram film-coated tablets Each film-coated tablet contains 600 micrograms of selexipag.
Slovak: Uptravi 600 mikrogramov filmom obalené tablety obsahuje 600 mikrogramov selexipagu.
English: Uptravi 1,400 microgram film-coated tablets Each film-coated tablet contains 1,400 micrograms of selexipag.
Slovak: Uptravi 1 400 mikrogramov filmom obalené tablety obsahuje 1 400 mikrogramov selexipagu.
English: Uptravi 600 microgram film-coated tablets: Round, light-violet, film-coated tablets with “6” marked on one side.
Slovak: Uptravi 600 mikrogramov filmom obalené tablety: okrúhle svetlofialové filmom obalené tablety s označením „6“ na jednej strane.
English: Uptravi 600 microgram film-coated tablets contain iron oxide red and iron oxide black (E172).
Slovak: Uptravi 600 mikrogramov filmom obalené tablety obsahuje červený oxid železitý a čierny oxid železitý (E172).
English: Uptravi 800 microgram film-coated tablets.
Slovak: Uptravi 800 mikrogramov filmom obalené tablety:
English: At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of a specific therapy for PAH, either an ERA (15%) or a PDE-5 inhibitor (32%) or both an ERA and a PDE-5 inhibitor (33%).
Slovak: %), alebo oboma ERA aj inhibítorom PDE-5 (33
English: Uptravi 1,200 microgram film-coated tablets: Round, dark-violet, film-coated tablets with “12” marked on one side.
Slovak: Uptravi 1 200 mikrogramov filmom obalené tablety: okrúhle tmavofialové filmom obalené tablety s označením „12“ na jednej strane.
English: • Patient Leaflet.
Slovak: %) pacientov na placebe.
English: Uptravi 1,400 microgram film-coated tablets: Round, dark-yellow, film-coated tablets with “14” marked on one side.
Slovak: Uptravi 1 400 mikrogramov filmom obalené tablety: okrúhle tmavožlté filmom obalené tablety s označením „14“ na jednej strane.
English: Uptravi 1,200 microgram film-coated tablet
Slovak: Uptravi 1 200 mikrogramov filmom obalené tablety
English: The number of deaths due to PAH up to study closure was 70 (12.2%) for the selexipag group and 83 (14.3%) for the placebo group.
Slovak: %) v skupine na selexipagu a 83 (14,3
English: Uptravi 1,600 microgram film-coated tablets Each film-coated tablet contains 1,600 micrograms of selexipag.
Slovak: Uptravi 1 600 mikrogramov filmom obalené tablety obsahuje 1 600 mikrogramov selexipagu.
English: Uptravi 400 microgram film-coated tablet
Slovak: Uptravi 400 mikrogramov filmom obalené tablety
English: Uptravi 1,400 microgram film-coated tablet
Slovak: Uptravi 1 400 mikrogramov filmom obalené tablety
English: Uptravi 1,000 microgram film-coated tablet
Slovak: Uptravi 1 000 mikrogramov filmom obalené tablety
English: Maintenance
Slovak: Dojčenie
English: Uptravi 600 microgram film-coated tablets
Slovak: Uptravi 600 mikrogramov filmom obalené tablety
English: Titration
Slovak: Vyrážka
English: Hypromellose, propylene glycol, titanium dioxide (E171),
Slovak: oxid titaničitý (E171),
English: Uptravi 1,600 microgram film-coated tablet
Slovak: Uptravi 1 600 mikrogramov filmom obalené tablety
English: Talk to your PAH doctor or nurse before taking Uptravi if you - are taking medicines for high blood pressure - have low blood pressure associated with symptoms such as dizziness - have recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting - have problems with your thyroid gland - have severe problems with your kidneys or are undergoing dialysis - have or have had severe problems with your liver not working properly
Slovak: ak ste v poslednom čase stratili významné množstvo krvi alebo tekutín napr. v dôsledku ťažkej hnačky alebo vracania. ak máte problémy so štítnou žľazou.
English: Uptravi 200 microgram film-coated tablets
Slovak: Uptravi 200 mikrogramov filmom obalené tablety
English: Uptravi 400 microgram film-coated tablets.
Slovak: Uptravi 400 mikrogramov filmom obalené tablety:
English: Uptravi 1,000 microgram film-coated tablets Each film-coated tablet contains 1,000 micrograms of selexipag.
Slovak: Uptravi 1 000 mikrogramov filmom obalené tablety obsahuje 1 000 mikrogramov selexipagu.
English: The number of patients who experienced, as a first event, death due to PAH or hospitalisation for PAH up to end of treatment was 102 (17.8%) in the selexipag group and 137 (23.5%) in the placebo group.
Slovak: PAH do ukončenia liečby, bol 102 (17,8
English: Uptravi 1,200 microgram film-coated tablets.
Slovak: Uptravi 1 200 mikrogramov filmom obalené tablety:
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), carnauba wax.
Slovak: oxid titaničitý (E171), čierny oxid železitý (E172), červený oxid železitý (E172),
English: In the presence of 400/100 mg lopinavir/ritonavir twice daily, a strong CYP3A4 inhibitor, exposure to selexipag increased approximately 2-fold, whereas the exposure to the active metabolite of selexipag did not change.
Slovak: Za prítomnosti 400/100 mg lopinaviru/ritonaviru dvakrát denne, ktorý je silným inhibítorom CYP3A4,