FrancophonIA/ELRC3.0 huggingface dataset:
English: These findings were in accordance with improvements in additional haemodynamic parameters.
Croatian: Ovi su nalazi bili sukladni poboljšanjima u dodatnim hemodinamskim parametrima.
English: In the longterm extension, more patients who switched from the placebo group to riociguat (21%) died than those who continued in the riociguat group (3%).
Croatian: U dugoročnom produžetku ispitivanja, umrlo je više bolesnika koji su prešli iz skupine s placebom na riocigvat (21%) nego onih koji su nastavili primati riocigvat (3%).
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Croatian: Ukupni riocigvat (ishodišni spoj i metaboliti) izlučuje se putem bubrega (33-45%) i žuči/stolicom (48-59%).
English: 14 to 62
Croatian: 14 do 62
English: Inoperable patient population
Croatian: Populacija inoperabilnih bolesnika
English: The most commonly reported adverse reactions, occurring in ≥10% of patients under Adempas treatment (up to 2.5 mg three times daily), were headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
Croatian: Najčešće zabilježene nuspojave, koje nastaju u ≥ 10% bolesnika liječenih lijekom Adempas (u dozi do 2,5 mg tri puta na dan), bile su glavobolja, omaglica, dispepsija, periferni edemi, mučnina, proljev i povraćanje.
English: PVR= pulmonary vascular resistance
Croatian: PVR=plućna vaskularna rezistencija (od engl. pulmonary vascular resistance)
English: RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to riociguat, in 61 adult PAH patients on stable PDE5 inhibitors.
Croatian: RESPITE je bilo nekontrolirano ispitivanje u trajanju od 24 tjedna, kojim se ispitivao prelazak s inhibitora PDE-5 na riocigvat, u 61 odraslog bolesnika s PAH-om na stabilnoj terapiji inhibitorima PDE-5.
English: Riociguat should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolisation.
Croatian: Riocigvat je potrebno izbjegavati u bolesnika s ozbiljnom hemoptizom u anamnezi ili onih u kojih je prethodno napravljena embolizacija bronhalnih arterija.
English: In pulmonary hypertension patients there is increased likelihood for respiratory tract bleeding, particularly among patients receiving anticoagulation therapy.
Croatian: U bolesnika s plućnom hipertenzijom povećana je vjerojatnost krvarenja u dišnom sustavu, osobito u bolesnika koji primaju antikoagulantnu terapiju.
English: In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see section 5.3).
Croatian: U ispitivanju reproduktivne toksičnosti na štakorima opažena je smanjena težina testisa, ali nije bilo učinaka na plodnost (vidjeti dio 5.3).
English: Highly active antiretroviral therapy (HAART)
Croatian: Visokoaktivna antiretrovirusna terapija (engl. highly active antiretroviral therapy, HAART)
English: Women of childbearing potential must use effective contraception during treatment with Adempas.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Adempas.
English: Common: may affect up to 1 in 10 people - inflammation of the stomach (gastritis) - inflammation in the digestive system (gastroenteritis) - reduction of red blood cells (anaemia) seen as pale skin, weakness or breathlessness - awareness of an irregular, hard, or rapid heartbeat (palpitation) - low blood pressure (hypotension) - nose bleed (epistaxis) - difficulty breathing through your nose (nasal congestion) - pain in the stomach, intestine or abdomen (gastrointestinal and abdominal pain) - heartburn (gastro-oesophageal reflux disease) - difficulty in swallowing (dysphagia) - constipation - bloating (abdominal distension)
Croatian: Često: mogu se javiti u do 1 na 10 osoba - upala želuca (gastritis) - upala u području probavnog sustava (gastroenteritis) - smanjenje broja crvenih krvnih stanica (anemija) koje se očituje blijedom kožom, slabošću ili nedostatkom zraka - svjesni osjećaj nepravilnih, jakih ili brzih otkucaja srca (palpitacija) - nizak krvni tlak (hipotenzija) - krvarenje iz nosa (epistaksa) - otežano disanje kroz nos (začepljen nos) - bol u želucu, crijevima ili trbuhu (gastrointestinalna ili abdominalna bol) - žgaravica (gastroezofagealna refluksna bolest) - otežano gutanje (disfagija) - zatvor - nadutost.
English: You should be aware of the side effects of this medicine before driving or using machines (see section 4).
Croatian: Trebate se upoznati s nuspojavama ovog lijeka prije upravljanja vozilima i rada sa strojevima (pogledajte dio 4).
English: The risk of serious and fatal respiratory tract bleeding may be further increased under treatment with riociguat, especially in the presence of risk factors, such as recent episodes of serious haemoptysis including those managed by bronchial arterial embolisation.
Croatian: Liječenje riocigvatom može dodatno pojačati rizik od ozbiljnog i smrtonosnog krvarenja u dišnom sustavu, osobito ako su prisutni čimbenici rizika, kao što su nedavne epizode ozbiljne hemoptize uključujući one liječene embolizacijom bronhalnih arterija.
English: Antacids should be taken at least 2 hours before, or 1 hour after riociguat.
Croatian: Primijenite antacide u razmaku od najmanje 2 sata prije ili 1 sata nakon riocigvata.
English: What Adempas contains
Croatian: Što Adempas sadrži
English: In nonsmoking individuals with mild (creatinine clearance 80-50 mL/min), moderate (creatinine clearance <50-30 mL/min) or severe (creatinine clearance <30 mL/min) renal impairment, riociguat plasma concentrations (AUC) were increased by 53%, 139% or 54%, respectively.
Croatian: U nepušača s blagim (klirens kreatinina 80-50 ml/min), umjerenim (klirens kreatinina < 50-30 ml/min) ili teškim (klirens kreatinina < 30 ml/min) oštećenjem funkcije bubrega, koncentracije riocigvata u plazmi (AUC) bile su povećane za 53%, 139% odnosno 54%.
English: Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Croatian: Uzimanje riocigvata s hranom blago smanjuje njegov AUC, a Cmax je bio smanjen za 35%.
English: Paediatric population No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja farmakokinetike riocigvata u pedijatrijskoj populaciji.
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early due to an increased risk of mortality and serious adverse events in patients treated with riociguat and a lack of efficacy.
Croatian: Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze II (RISE-IIP) u kojem su se ocjenjivale djelotvornost i sigurnost riocigvata u bolesnika sa simptomatskom plućnom hipertenzijom povezanom s idiopatskim intersticijskim pneumonijama (PH-IIP) prekinuto je ranije zbog povećanog rizika od smrtnosti i ozbiljnih štetnih događaja u bolesnika liječenih riocigvatom i izostanka djelotvornosti.
English: Patients with any clinical worsening Death
Croatian: Događaji koji pokazuju kliničko pogoršanje
English: There is no experience in the use of Adempas in other types of PAH.
Croatian: Nema iskustva s primjenom lijeka Adempas kod drugih tipova PAH-a.
English: The recommended starting dose is 1 mg three times daily for 2 weeks.
Croatian: Preporučena početna doza je 1 mg tri puta na dan tijekom 2 tjedna.
English: Placebo-adjusted difference (dyn·s·cm-5)
Croatian: Placebom prilagođena razlika (dyn·s·cm-5)
English: Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Croatian: Veličine pakiranja: 42, 84, 90 ili 294 filmom obloženih tableta
English: More patients taking riociguat died (11% vs. 4%) and had serious adverse events (37% vs. 23%) during the main phase.
Croatian: Tijekom osnovne faze više bolesnika koji su dobivali riocigvat je umrlo (11% nasuprot 4%) i imalo ozbiljne nuspojave (37% nasuprot 23%).
English: It is recommended to monitor for signs and symptoms of hypotension after any transition (see sections 4.3, 4.5 and 5.1).
Croatian: Preporučuje se praćenje znakova i simptoma hipotenzije nakon bilo kojeg prijelaza (vidjeti dijelove 4.3, 4.5 i 5.1).
English: Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of the NO-sGC-cGMP pathway.
Croatian: Plućna hipertenzija povezana je s poremećajem funkcije endotela, oštećenom sintezom NO i nedostatnom stimulacijom puta NO-sGC-cGMP.
English: 42 film-coated tablets 84 film-coated tablets 90 film-coated tablets 294 film-coated tablets
Croatian: 42 filmom obložene tablete 84 filmom obložen4 tablete 90 filmom obloženih tableta 294 filmom obložene tablete
English: Women of childbearing potential / Contraception
Croatian: Žene u reproduktivnoj dobi / kontracepcija
English: In a fertility study in rats, decreased testes weights occurred at systemic exposure of about 7-fold of human exposure, whereas no effects on male and female fertility were seen.
Croatian: U ispitivanjima plodnosti na štakorima, smanjena težina testisa nastala je kod sistemske izloženosti koja je bila oko 7 puta veća od izloženosti u ljudi, dok učinci na plodnost u mužjaka i ženki nisu bili opaženi.
English: Haemoptysis, Epistaxis, Nasal congestion
Croatian: Hemoptiza, Epistaksa, Kongestija nosa
English: Serious haemoptysis occurred in 1% (5/490) patients taking riociguat compared to 0/214 patients taking placebo, including one event with fatal outcome.
Croatian: Ozbiljna hemoptiza nastupila je u 1% (5/490) bolesnika koji su uzimali riocigvat u usporedbi s 0/214 bolesnika koji su primali placebo, uključujući jedan događaj sa smrtnim ishodom.
English: Serious bleeding occurred in 2.4% (12/490) of patients taking riociguat compared to 0/214 of placebo patients.
Croatian: Ozbiljno krvarenje nastupilo je u 2,4% (12/490) bolesnika koji su uzimali riocigvat u usporedbi s 0/214 bolesnika koji su primali placebo.
English: Talk to your doctor or pharmacist before taking Adempas if: you have recently experienced serious bleeding from the lung, or if you have undergone treatment to stop coughing up blood (bronchial arterial embolisation).
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Adempas ako: - ste nedavno imali ozbiljno krvarenje iz pluća ili ste bili podvrgnuti liječenju da se zaustavi iskašljavanje krvi (embolizacija bronhijalnih arterija).
English: For patients who are unable to swallow whole tablets, Adempas tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally (see section 5.2).
Croatian: Za bolesnike koji ne mogu progutati cijele tablete, tablete lijeka Adempas mogu se zdrobiti i pomiješati s vodom ili mekom hranom kao što je kaša od jabuke neposredno prije peroralne primjene (vidjeti dio 5.2).
English: Adempas is a film-coated tablet:
Croatian: Adempas je filmom obložena tableta:
English: Therefore, caution should be exercised when administering riociguat in these patients.
Croatian: Stoga je potreban oprez kad se riocigvat primjenjuje u ovih bolesnika.
English: Serious haemorrhagic events also included 2 patients with vaginal haemorrhage, 2 with catheter site haemorrhage, and 1 each with subdural haematoma, haematemesis, and intra-abdominal haemorrhage.
Croatian: Ozbiljni hemoragijski događaji također su uključivali 2 bolesnice s vaginalnom hemoragijom, 2 bolesnika s krvarenjem na mjestu katetera i po jednog s subduralnim hematomom, hematemezom i intraabdominalnim krvarenjem.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bayer (Logo)
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer (Logo)
English: - The active substance is riociguat.
Croatian: - Djelatna tvar je riocigvat.
English: If at any time during the up-titration phase systolic blood pressure decreases below 95 mmHg and the patient shows signs or symptoms of hypotension the current dose should be decreased by 0.5 mg three times daily.
Croatian: Ako se u bilo kojem trenutku tijekom faze postupnog povećavanja doze sistolički krvni tlak snizi na manje od 95 mmHg i bolesnik pokazuje znakove ili simptome hipotenzije, trenutnu dozu se mora sniziti za 0,5 mg tri puta na dan.
English: Studies in animals have shown reproductive toxicity and placental transfer (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost i prijenos preko posteljice (vidjeti dio 5.3).
English: Riociguat and its main metabolite are not inhibitors or inducers of major CYP isoforms (including CYP 3A4) or transporters (e.g. P-gp/BCRP) in vitro at therapeutic plasma concentrations.
Croatian: Riocigvat i njegov glavni metabolit nisu inhibitori niti induktori glavnih izooblika CYP-a (uključujući CYP3A4) ili transportere (npr. P-gp/BCRP) in vitro pri terapijskim koncentracijama u plazmi.
English: Patients were either treatment-naïve (50%) or pre-treated with ERA (43%) or a prostacyclin analogue (inhaled (iloprost), oral (beraprost) or subcutaneous (treprostinil); 7%) and had been diagnosed with idiopathic or heritable PAH (63.4%), PAH associated with connective tissue disease (25.1%) and congenital heart disease (7.9%).
Croatian: Bolesnici nisu prethodno primali nikakvo liječenje (50%) ili su prethodno bili liječeni ERA-om (43%) ili analogom prostaciklina (inhalacijski (iloprost), peroralno (beraprost) ili supkutano (treprostinil); 7%) i bio im je dijagnosticiran idiopatski ili nasljedni PAH (63,4%), PAH povezan s bolešću vezivnog tkiva (25,1%) i kongenitalna srčana bolest (7,9%).
English: In case of respiratory tract bleeding, the prescriber should regularly assess the benefitrisk of treatment continuation.
Croatian: U slučaju krvarenja u dišnom sustavu, liječnik koji propisuje lijek mora redovito procjenjivati omjer koristi i rizika od nastavka liječenja.
English: Bosentan, reported to be a moderate inducer of CYP3A4, led to a decrease of riociguat steady-state plasma concentrations in PAH patients by 27% (see sections 4.1 and 5.1).
Croatian: Bosentan, zabilježen kao umjereni induktor CYP3A4, doveo je do sniženja koncentracije riocigvata u plazmi u stanju dinamičke ravnoteže u bolesnika s PAH-om za 27% (vidjeti dijelove 4.1 i 5.1).
English: Therefore, administration of riociguat to such patients is not recommended.
Croatian: Stoga se ne preporučuje primjena riocigvata u takvih bolesnika.
English: Corresponding values for the main metabolite were higher in subjects with renal impairment compared to healthy subjects.
Croatian: Odgovarajuće vrijednosti glavnog metabolita bile su veće u ispitanika s oštećenjem funkcije bubrega nego u zdravih ispitanika.
English: Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Croatian: Nemojte uzimati Adempas: - ako uzimate određene lijekove koji se zovu PDE-5 inhibitori (npr. sildenafil, tadalafil,
English: If systolic blood pressure falls below 95 mmHg, the dose should be maintained provided the patient does not show any signs or symptoms of hypotension.
Croatian: Ako se sistolički krvni tlak snizi na manje od 95 mmHg, dozu se mora održati na istoj razini pod uvjetom da bolesnik ne pokazuje nikakve znakove ili simptome hipotenzije.
English: Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
Croatian: Adempas je indiciran za liječenje odraslih bolesnika funkcionalnog razreda II do III prema Svjetskoj zdravstvenoj organizaciji (SZO) s
English: If you are transitioning between sildenafil or tadalafil and Adempas If you are stopping sildenafil, you must wait at least 24 hours before you take Adempas.
Croatian: Ako prelazite između sildenafila ili tadalafila i lijeka Adempas - Ako prestajete sa sildenafilom, morate pričekati najmanje 24 sata prije nego uzmete Adempas.
English: If you are stopping Adempas to change to another medicine called a PDE5 inihibitor (e.g. sildenafil or tadalafil) you must wait at least 24 hours from your last dose of Adempas before you take the PDE5 inhibitor.
Croatian: Ako prestajete s lijekom Adempas kako bi se prebacili na drugi lijek koji se naziva inhibitor PDE-5 (npr. sildenafil ili tadalafil), morate pričekati najmanje 24 sata od zadnje doze lijeka Adempas prije nego uzmete inhibitor PDE-5.
English: Further exploratory subgroup analysis revealed a treatment effect of 26 m, (95% CI: 5 m to 46 m) in patients pre-treated with ERAs (n=167) and a treatment effect of 101 m (95% CI: 27 m to 176 m) in patients pre-treated with prostacyclin analogues (n=27).
Croatian: Daljnja eksplorativna analiza podskupina otkrila je učinak liječenja od 26 m, (95% CI: 5 m do 46 m) u bolesnika prethodno liječenih ERA-ovima (n=167) i učinak liječenja od 101 m (95% CI: 27 m do 176 m) u bolesnika prethodno liječenih analozima prostaciklina (n=27).
English: Before prescribing riociguat, physicians should carefully consider whether patients with certain underlying conditions, could be adversely affected by vasodilatory effects (e.g. patients on antihypertensive therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction).
Croatian: Prije propisivanja riocigvata, liječnici moraju pažljivo razmotriti mogu li vazodilatacijski učinci štetno utjecati na bolesnike s određenim osnovnim bolestima (npr. bolesnike na antihipertenzivnoj terapiji ili s hipotenzijom u mirovanju, hipovolemijom, teškom opstrukcijom izgonskog dijela lijeve klijetke ili poremećajem funkcije autonomnog živčanog sustava).
English: Your doctor will increase the dose every 2 weeks to a maximum of 2.5 mg 3 times a day (maximum daily dose of 7.5 mg) unless you experience any side effects or very low blood pressure.
Croatian: Liječnik će Vam povećavati dozu svaka 2 tjedna do najviše 2,5 mg 3 puta na dan (najviša dnevna doza od 7,5 mg) osim ako osjetite neke nuspojave ili Vam krvni tlak bude jako nizak.
English: In growing, juvenile and adolescent rats, effects on bone formation were seen.
Croatian: U mladunčadi i adolescentnih štakora koji još rastu opaženi su učinci na stvaranje kosti.
English: Pulmonary haemorrhage*
Croatian: Plućno krvarenje*
English: you feel short of breath during treatment with this medicine, this can be caused by a build-up of fluid in the lungs.
Croatian: - osjetite nedostatak zraka tijekom liječenja lijekom Adempas, to može biti prouzročeno nakupljenom tekućinom u plućima.
English: Concomitant administration of 400 mg once daily ketoconazole led to a 150% (range up to 370%) increase in riociguat mean AUC and a 46% increase in mean Cmax.
Croatian: Istodobna primjena 400 mg ketokonazola jedanput na dan dovela je do 150%-tnog povećanja (raspon do 370%) srednje vrijednosti AUC-a riocigvata i 46%-tnog povećanja srednje vrijednosti Cmax.
English: • In patients on stable doses of Adempas, the initiation of strong multi pathway CYP and P-gp/BCRP inhibitors is not recommended as no dosage recommendation can be given due to limited data.
Croatian: • U bolesnika na stabilnim dozama lijeka Adempas, započinjanje terapije jakim inhibitorima više puteva CYP-a i P-gp-a/BCRP-a se ne preporučuje, s obzirom na to da ne postoje preporuke doziranja zbog ograničenih podataka.
English: Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.
Croatian: Dozu se mora povećavati za 0,5 mg tri puta na dan svaka dva tjedna do najviše 2,5 mg tri puta na dan, ako je sistolički krvni tlak ≥ 95 mmHg i bolesnik nema znakove ili simptome hipotenzije.
English: In some PAH patients, an adequate response on the 6-minute walk distance (6MWD) may be reached at a dose of 1.5 mg three times a day (see section 5.1).
Croatian: U nekih bolesnika s PAH-om može se postići zadovoljavajući odgovor na liječenje procijenjen testom 6-minutnog hoda (6MWD) pri dozi od 1,5 mg tri puta na dan (vidjeti dio 5.1).
English: 25 to 67 [<0.0001]
Croatian: 25 do 67 [< 0,0001]
English: For patients prone to hypotension, as a precautionary measure, switches between fed and fasted Adempas intake are not recommended because of increased peak plasma levels of riociguat in the fasting compared to the fed state (see section 5.2).
Croatian: Za bolesnike sklone hipotenziji, kao mjera predostrožnosti, ne preporučuju se izmjene između uzimanja lijeka Adempas s hranom pa natašte zbog povišenih vršnih razina u plazmi riocigvata uzetog natašte u usporedbi s onima nakon uzimanja hrane (vidjeti dio 5.2).
English: Inter-ethnic differences Pharmacokinetic data reveal no relevant inter-ethnic differences.
Croatian: Međuetničke razlike Farmakokinetički podaci nisu pokazali važne međuetničke razlike.
English: Medicinal products strongly inhibiting P-gp/BCRP such as the immuno-suppressive cyclosporine A, should be used with caution (see sections 4.4 and 5.2).
Croatian: Lijekovi koji jako inhibiraju P-gp/BCRP, poput imunosupresiva ciklosporina A, moraju se primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
English: Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.
Croatian: Adempas, kao monoterapija ili u kombinaciji s antagonistima endotelinskih receptora, indiciran je za liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) funkcionalnog razreda II do III prema SZO-u za poboljšanje tolerancije napora.
English: (in 2 mg and 2.5 mg tablets only)
Croatian: (samo u tabletama od 2 mg i 2,5 mg)
English: Different weight categories Pharmacokinetic data reveal no relevant differences due to weight in the exposure to riociguat.
Croatian: Različite kategorije tjelesne težine Farmakokinetički podaci nisu pokazali važne razlike zbog tjelesne težine u izloženosti riocigvatu.
English: In rats, an increased rate of cardiac malformation was observed as well as a reduced gestation rate due to early resorption at maternal systemic exposure of about 7-fold of human exposure (2.5 mg three times daily).
Croatian: U štakora je bila opažena povećana stopa srčanih malformacija, kao i smanjena stopa gestacije zbog rane resorpcije kod sistemske izloženosti majke koja je bila oko 7 puta veća od izloženosti u ljudi (2,5 mg tri puta na dan).
English: Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding.
Croatian: Zbog mogućih ozbiljnih nuspojava u dojenčadi, Adempas se ne smije primjenjivati tijekom dojenja.
English: The recommended starting dose is a 1-mg tablet taken 3 times a day for 2 weeks.
Croatian: Preporučena početna doza je 1 tableta od 1 mg koja se uzima 3 puta na dan tijekom 2 tjedna.