natgillin/translations-raw huggingface dataset:
The use of riociguat in other forms of PAH not studied is not recommended (see section 5.1).
Ne preporučuje se primjena riocigvata u drugim oblicima PAH-a koji nisu ispitani (vidjeti dio 5.1).
Non-clinical data show undesirable effects on growing bone (see section 5.3).
Neklinički podaci pokazuju neželjene učinke na rast kostiju (vidjeti dio 5.3).
Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Riocigvat se ne smije primjenjivati u bolesnika sa sistoličkim krvnim tlakom nižim od 95 mmHg (vidjeti dio 4.3).
In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
U kroničnoj tromboembolijskoj plućnoj hipertenziji, izbor liječenja je plućna endarterektomija jer je to potencijalno kurativna opcija.
Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator.
Riocigvat je vrsta lijeka koji se zove stimulator gvanilatciklaze (sGC).
An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
Otvoreni produžetak ispitivanja (CHEST-2) uključio je 237 bolesnika koji su završili ispitivanje CHEST-1.
In juvenile rats, the changes consisted of thickening of trabecular bone and of hyperostosis and remodeling of metaphyseal and diaphyseal bone, whereas in adolescent rats an overall increase of bone mass was observed.
U mladunčadi štakora, promjene su se sastojale od zadebljanja trabekularne kosti i hiperostoze te remodeliranja metafiza i dijafiza kostiju, dok je u adolescentnih štakora opaženo općenito povećanje koštane mase.
Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Liječnik će pratiti Vaše zdravstveno stanje te će razmotriti primjenu smanjene početne doze lijeka Adempas.
Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease.
Ako prestanete uzimati Adempas Nemojte prestati uzimati ovaj lijek a da prethodno o tome niste razgovarali sa svojim liječnikom, zato što ovaj lijek sprječava napredovanje bolesti.
Plasma protein binding in humans is high at approximately 95%, with serum albumin and alpha 1-acidic glycoprotein being the main binding components.
Vezanje za proteine plazme u ljudi je visoko i iznosi približno 95%, s time da su serumski albumin i alfa 1-kiseli glikoprotein glavne komponente za koje se veže.
- Patients with systolic blood pressure < 95 mm Hg at treatment initiation.
- Bolesnici sa sistoličkim krvnim tlakom < 95 mmHg na početku liječenja.
Effects of other substances on riociguat
Učinci drugih lijekova na riocigvat
There is a direct relationship between riociguat plasma concentration and haemodynamic parameters such as systemic and pulmonary vascular resistance, systolic blood pressure and cardiac output.
Postoji izravan odnos između koncentracije riocigvata u plazmi i hemodinamičkih parametara kao što su sistemski i plućni vaskularni otpor, sistolički krvni tlak i srčani minutni volumen.
Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Učinci opaženi u ispitivanjima toksičnosti ponovljenih doza bili su uglavnom posljedica pretjeranog farmakodinamičkog djelovanja riocigvata (hemodinamički učinci i relaksirajući učinci na glatke mišiće).
An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
Otvoreni produžetak ispitivanja (PATENT-2) uključio je 396 bolesnika koji su dovršili ispitivanje PATENT-1 do datuma završetka ispitivanja.
Therefore, drug-drug interactions by inhibition of CYP1A1 could result in increased riociguat exposure, especially in smokers (see section 5.2).
Stoga bi interakcije između lijekova putem inhibicije CYP1A1 mogle dovesti do povećane izloženosti riocigvatu, osobito u pušača (vidjeti dio 5.2).
If you are stopping tadalafil, you must wait at least 48 hours before you take Adempas.
- Ako prestajete s tadalafilom, morate pričekati najmanje 48 sati prije nego uzmete Adempas.
Your dose may need to be adjusted.
Možda će Vam trebati prilagoditi dozu.
CYP1A1 catalyses the formation of riociguat's main metabolite in liver and lungs and is known to be inducible by polycyclic aromatic hydrocarbons, which, for example, are present in cigarette smoke.
CYP1A1 katalizira stvaranje glavnog metabolita riocigvata u jetri i plućima, a poznato je da ga induciraju policiklički aromatski ugljikovodici, koji su prisutni, na primjer, u duhanskom dimu.
Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath.
Budući da srce mora raditi jače nego uobičajeno, ljudi s povišenim tlakom u plućima osjećaju umor, omaglicu i nedostatak zraka.
Most of the adverse reactions are caused by relaxation of smooth muscle cells in vasculature or the gastrointestinal tract.
Većina nuspojava uzrokovana je opuštanjem stanica glatkih mišića u krvnim žilama ili gastrointestinalnom traktu.
Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels.
Adempas se može koristiti za liječenje odraslih bolesnika s određenim oblicima plućne hipertenzije, stanja u kojem su plućne krvne žile postale sužene, što otežava srcu pumpanje krvi kroz njih i vodi do povišenog krvnog tlaka u žilama.
• acute bleeding from the lungs (pulmonary haemorrhage) may result in coughing up blood, cases with fatal outcomes were observed (uncommon side effect, may affect up to 1 in 100 people).
• akutno krvarenje iz pluća (plućna hemoragija) može rezultirati iskašljavanjem krvi, zabilježeni su slučajevi sa smrtnim ishodom (manje česta nuspojava, može se javiti u do 1 na 100 osoba).
Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.
Približno 9-44% primijenjene doze pronađeno je kao nepromijenjeni riocigvat u stolici.
iron oxide red (E 172)
željezov oksid, crveni (E 172)
The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Sigurnost lijeka Adempas procijenjena je u ispitivanjima faze III u 681 bolesnika s KTEPH-om i PAH-om koji su primili najmanje jednu dozu riocigvata (vidjeti dio 5.1).
These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Ovi su nalazi bili sukladni poboljšanjima dodatnih hemodinamičkih parametara (vidjeti tablicu 5).
Your dose may be adjusted.
Možda će Vam prilagoditi dozu.
-11 to 31
-11 do 31
For the transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and for tadalafil 3 days.
Za prelazak s inhibitora PDE-5 na riocigvat, medijan vremena bez liječenja za sildenafil bio je 1 dan, a za tadalafil 3 dana.
Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Bolesnici s ALT > 3 x GGN i bilirubinom > 2 x GGN nisu bili ispitani (vidjeti dio 4.4).
Breast-feeding should be discontinued during treatment with this medicinal product.
Dojenje se mora prekinuti za vrijeme liječenja ovim lijekom.
In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
U starijih bolesnika (u dobi od 65 godina i starijih) postoji povećan rizik od hipotenzije pa je stoga potreban poseban oprez tijekom individualne titracije doze (vidjeti dio 5.2).
Should signs of pulmonary oedema occur, the possibility of associated PVOD should be considered and treatment with riociguat should be discontinued.
Ako nastanu znakovi plućnog edema, potrebno je razmotriti mogućnost povezanosti s PVOB-om i prekinuti liječenje riocigvatom.
There is no clinical experience with riociguat in patients with elevated liver aminotransferases (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (> 2 x ULN) prior to initiation of treatment; riociguat is not recommended in these patients.
Nema kliničkog iskustva s riocigvatom u bolesnika s povišenim vrijednostima jetrenih aminotransferaza (> 3 x gornje granice normale (GGN)) ili povećanim direktnim bilirubinom (> 2 x GGN) prije početka liječenja; riocigvat se ne preporučuje u ovih bolesnika.
With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Kod viših su doza u nekim slučajevima bili opaženi i više nego aditivni učinci na sistemski krvni tlak.
Improvements in 6MWD persisted at 2 years in PATENT-2.
Poboljšanje 6MWD-a nastavilo se tijekom 2 godine u ispitivanju PATENT-2.
IIP) (see section 5.1)
(PH-IIP) (vidjeti dio 5.1).
If you are older than 65 years, you have an increased risk of developing low blood pressure.
Ako ste stariji od 65 godina, imate povišen rizik od pojave niskog tlaka.
Riociguat restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP.
Riocigvat obnavlja put NO-sGC-cGMP i dovodi do povećanog stvaranja cGMP.
Improvements in 6MWD persisted at 2 years in CHEST-2.
Poboljšanje 6MWD-a nastavilo se tijekom 2 godine u ispitivanju CHEST-2.
Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO).
Riocigvat je stimulator topljive gvanilat-ciklaze (sGC), enzima u kardiopulmonalnom sustavu i receptora za dušikov oksid (NO).
Moderate passage across the placental barrier was observed.
Opažen je umjereni prolazak riocigvata kroz placentalnu barijeru.
Table 1: Adverse reactions reported with Adempas in the phase III studies MedDRA
Tablica 1: Nuspojave zabilježene uz Adempas u ispitivanjima faze III
Adempas is only prescribed for certain forms of PAH, i.e. idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease.
Adempas se propisuje samo za određene oblike PAH-a, odnosno za idiopatski PAH (uzrok PAH-a je nepoznat), nasljedni PAH i PAH uzrokovan bolešću vezivnog tkiva.
In the long term extension part of this study (non controlled) the concomitant use of sildenafil and riociguat resulted in a high rate of discontinuation, predominately due to hypotension.
U dugoročnom nastavku ovog ispitivanja (nekontroliranom) istodobna primjena sildenafila i riocigvata dovela je do visoke stope prekida liječenja, pretežno zbog hipotenzije.
29 to 79
29 do 79
Adempas has moderate influence on the ability to drive and use machines.
Adempas umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
Cobicistat, ritonavir, atazanavir and darunavir are additionally classified as CYP3A inhibitors.
Kobicistat, ritonavir, atazanavir i darunavir dodatno se klasificiraju kao CYP3A inhibitori.
If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine because it might harm your baby.
Ako dojite ili planirate dojiti, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek, zato što može naškoditi djetetu.
Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.
Vaš će liječnik odlučiti zajedno s Vama hoćete li prestati dojiti ili prekinuti liječenje lijekom Adempas.
Lack of pharmacokinetic interactions between riociguat and the CYP2C9 substrate warfarin was demonstrated in vivo.
Nedostatak farmakokinetičkih interakcija između riocigvata i supstrata CYP2C9 varfarina dokazan je in vivo.
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Plućni vazodilatatori mogu značajno pogoršati kardiovaskularno stanje bolesnika s plućnom venookluzivnom bolešću (PVOB).
Strong CYP1A1 inhibitors should be used with caution (see section 4.4).
Jaki inhibitori CYP1A1 moraju se primjenjivati s oprezom (vidjeti dio 4.4).
It sensitises sGC to endogenous NO by stabilising the NO-sGC binding.
Senzibilizira sGC na endogeni NO tako što stabilizira vezu NO-sGC.
Approximately 4-19% of the administered dose was excreted as unchanged riociguat via the kidneys.
Približno 4-19% primijenjene doze bilo je izlučeno kao nepromijenjeni riocigvat putem bubrega.
Dizziness has been reported and may affect the ability to drive and use machines (see section 4.8).
Zabilježena je omaglica koja može utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
Bolesnici s bilo kakvim kliničkim pogoršanjem smrt hospitalizacije zbog PH smanjenje 6MWD zbog PH uporno pogoršavanje funkcionalnog razreda zbog PH početak novog liječenja PH
These findings were in accordance with improvements in additional haemodynamic parameters.
Ovi su nalazi bili sukladni poboljšanjima u dodatnim hemodinamskim parametrima.
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%).
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%).
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.
• 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).
Total riociguat (parent compound and metabolites) is excreted via both renal (33-45%) and biliary/faecal routes (48-59%).
Ukupni riocigvat (ishodišni spoj i metaboliti) izlučuje se putem bubrega (33-45%) i žuči/stolicom (48-59%).
14 to 62
14 do 62
Inoperable patient population
Populacija inoperabilnih bolesnika
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.
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.
PVR= pulmonary vascular resistance
PVR=plućna vaskularna rezistencija (od engl. pulmonary vascular resistance)
RESPITE was a 24-week, uncontrolled study to investigate switching from PDE5 inhibitors to riociguat, in 61 adult PAH patients on stable PDE5 inhibitors.
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.
Riociguat should be avoided in patients with a history of serious haemoptysis or who have previously undergone bronchial arterial embolisation.
Riocigvat je potrebno izbjegavati u bolesnika s ozbiljnom hemoptizom u anamnezi ili onih u kojih je prethodno napravljena embolizacija bronhalnih arterija.
In pulmonary hypertension patients there is increased likelihood for respiratory tract bleeding, particularly among patients receiving anticoagulation therapy.
U bolesnika s plućnom hipertenzijom povećana je vjerojatnost krvarenja u dišnom sustavu, osobito u bolesnika koji primaju antikoagulantnu terapiju.
In a reproduction toxicity study in rats, decreased testes weights were seen, but there were no effects on fertility (see section 5.3).
U ispitivanju reproduktivne toksičnosti na štakorima opažena je smanjena težina testisa, ali nije bilo učinaka na plodnost (vidjeti dio 5.3).
Highly active antiretroviral therapy (HAART)
Visokoaktivna antiretrovirusna terapija (engl. highly active antiretroviral therapy, HAART)
Women of childbearing potential must use effective contraception during treatment with Adempas.
Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Adempas.
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)
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.
You should be aware of the side effects of this medicine before driving or using machines (see section 4).
Trebate se upoznati s nuspojavama ovog lijeka prije upravljanja vozilima i rada sa strojevima (pogledajte dio 4).
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.
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.
Antacids should be taken at least 2 hours before, or 1 hour after riociguat.
Primijenite antacide u razmaku od najmanje 2 sata prije ili 1 sata nakon riocigvata.
What Adempas contains
Što Adempas sadrži
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.
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%.
Intake with food reduced riociguat AUC slightly, Cmax was reduced by 35%.
Uzimanje riocigvata s hranom blago smanjuje njegov AUC, a Cmax je bio smanjen za 35%.
Paediatric population No studies have been conducted to investigate the pharmacokinetics of riociguat in paediatric patients.
Pedijatrijska populacija Nisu provedena ispitivanja farmakokinetike riocigvata u pedijatrijskoj populaciji.
If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
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.
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.
Patients with any clinical worsening Death
Događaji koji pokazuju kliničko pogoršanje
There is no experience in the use of Adempas in other types of PAH.
Nema iskustva s primjenom lijeka Adempas kod drugih tipova PAH-a.
The recommended starting dose is 1 mg three times daily for 2 weeks.
Preporučena početna doza je 1 mg tri puta na dan tijekom 2 tjedna.
Placebo-adjusted difference (dyn·s·cm-5)
Placebom prilagođena razlika (dyn·s·cm-5)
Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Veličine pakiranja: 42, 84, 90 ili 294 filmom obloženih tableta
More patients taking riociguat died (11% vs. 4%) and had serious adverse events (37% vs. 23%) during the main phase.
Tijekom osnovne faze više bolesnika koji su dobivali riocigvat je umrlo (11% nasuprot 4%) i imalo ozbiljne nuspojave (37% nasuprot 23%).
It is recommended to monitor for signs and symptoms of hypotension after any transition (see sections 4.3, 4.5 and 5.1).
Preporučuje se praćenje znakova i simptoma hipotenzije nakon bilo kojeg prijelaza (vidjeti dijelove 4.3, 4.5 i 5.1).
Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of NO and insufficient stimulation of the NO-sGC-cGMP pathway.
Plućna hipertenzija povezana je s poremećajem funkcije endotela, oštećenom sintezom NO i nedostatnom stimulacijom puta NO-sGC-cGMP.
42 film-coated tablets 84 film-coated tablets 90 film-coated tablets 294 film-coated tablets
42 filmom obložene tablete 84 filmom obložen4 tablete 90 filmom obloženih tableta 294 filmom obložene tablete
Women of childbearing potential / Contraception
Žene u reproduktivnoj dobi / kontracepcija
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.
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.
Haemoptysis, Epistaxis, Nasal congestion
Hemoptiza, Epistaksa, Kongestija nosa
Serious haemoptysis occurred in 1% (5/490) patients taking riociguat compared to 0/214 patients taking placebo, including one event with fatal outcome.
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.
Serious bleeding occurred in 2.4% (12/490) of patients taking riociguat compared to 0/214 of placebo patients.
Ozbiljno krvarenje nastupilo je u 2,4% (12/490) bolesnika koji su uzimali riocigvat u usporedbi s 0/214 bolesnika koji su primali placebo.
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).
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).
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).
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).