natgillin/translations-raw huggingface dataset:
Adempas is a film-coated tablet:
Adempas je filmom obložena tableta:
Therefore, caution should be exercised when administering riociguat in these patients.
Stoga je potreban oprez kad se riocigvat primjenjuje u ovih bolesnika.
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.
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.
NAME OF THE MARKETING AUTHORISATION HOLDER Bayer (Logo)
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer (Logo)
- The active substance is riociguat.
- Djelatna tvar je riocigvat.
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.
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.
Studies in animals have shown reproductive toxicity and placental transfer (see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost i prijenos preko posteljice (vidjeti dio 5.3).
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.
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.
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%).
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%).
In case of respiratory tract bleeding, the prescriber should regularly assess the benefitrisk of treatment continuation.
U slučaju krvarenja u dišnom sustavu, liječnik koji propisuje lijek mora redovito procjenjivati omjer koristi i rizika od nastavka liječenja.
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).
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).
Therefore, administration of riociguat to such patients is not recommended.
Stoga se ne preporučuje primjena riocigvata u takvih bolesnika.
Corresponding values for the main metabolite were higher in subjects with renal impairment compared to healthy subjects.
Odgovarajuće vrijednosti glavnog metabolita bile su veće u ispitanika s oštećenjem funkcije bubrega nego u zdravih ispitanika.
Do not take Adempas: - if you are taking certain medicines called PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
Nemojte uzimati Adempas: - ako uzimate određene lijekove koji se zovu PDE-5 inhibitori (npr. sildenafil, tadalafil,
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.
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.
Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
Adempas je indiciran za liječenje odraslih bolesnika funkcionalnog razreda II do III prema Svjetskoj zdravstvenoj organizaciji (SZO) s
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.
Ako prelazite između sildenafila ili tadalafila i lijeka Adempas - Ako prestajete sa sildenafilom, morate pričekati najmanje 24 sata prije nego uzmete Adempas.
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.
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.
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).
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).
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).
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).
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.
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.
In growing, juvenile and adolescent rats, effects on bone formation were seen.
U mladunčadi i adolescentnih štakora koji još rastu opaženi su učinci na stvaranje kosti.
Pulmonary haemorrhage*
Plućno krvarenje*
you feel short of breath during treatment with this medicine, this can be caused by a build-up of fluid in the lungs.
- osjetite nedostatak zraka tijekom liječenja lijekom Adempas, to može biti prouzročeno nakupljenom tekućinom u plućima.
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.
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.
• 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.
• 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.
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.
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.
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).
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).
25 to 67 [<0.0001]
25 do 67 [< 0,0001]
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).
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).
Inter-ethnic differences Pharmacokinetic data reveal no relevant inter-ethnic differences.
Međuetničke razlike Farmakokinetički podaci nisu pokazali važne međuetničke razlike.
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).
Lijekovi koji jako inhibiraju P-gp/BCRP, poput imunosupresiva ciklosporina A, moraju se primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
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.
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.
(in 2 mg and 2.5 mg tablets only)
(samo u tabletama od 2 mg i 2,5 mg)
Different weight categories Pharmacokinetic data reveal no relevant differences due to weight in the exposure to riociguat.
Različite kategorije tjelesne težine Farmakokinetički podaci nisu pokazali važne razlike zbog tjelesne težine u izloženosti riocigvatu.
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).
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).
Due to the potential for serious adverse reactions in breast-fed infants Adempas should not be used during breast-feeding.
Zbog mogućih ozbiljnih nuspojava u dojenčadi, Adempas se ne smije primjenjivati tijekom dojenja.
The recommended starting dose is a 1-mg tablet taken 3 times a day for 2 weeks.
Preporučena početna doza je 1 tableta od 1 mg koja se uzima 3 puta na dan tijekom 2 tjedna.
Inhibitors for the UDP-Glykosyltransferases (UGT) 1A1 and 1A9 may potentially increase the exposure of the riociguat metabolite M1, which is pharmacologically active (pharmacological activity: 1/10th to 1/3rd of riociguat).
Inhibitori UDP-glikoziltransferaza (UGT) 1A1 i 1A9 mogu potencijalno povećati izloženost metabolitu riocigvata M1, koji je farmakološki aktivan (farmakološka aktivnost: 1/10 do 1/3 riocigvata).
Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Djelotvornost je dokazana u populaciji s PAH-om koja etiološki uključuje idiopatski ili nasljedni PAH ili PAH povezan s bolešću vezivnog tkiva (vidjeti dio 5.1).
There are no data from the use of riociguat in pregnant women.
Nema podataka o primjeni riocigvata u trudnica.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - PACKS OF 42, 84, 90, 294 FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER - PAKIRANJA S 42, 84, 90, 294 FILMOM OBLOŽENIH
How to take Adempas
Kako uzimati Adempas
Keep this medicine out of the sight and reach of children.
Kako čuvati Adempas Lijek čuvajte izvan pogleda i dohvata djece.
Consider a dose reduction for patients on Adempas doses higher than or equal to 1.0 mg if the patient develops signs or symptoms of hypotension (see sections 4.4 and 4.5).
U bolesnika na dozama lijeka Adempas višim od ili jednakim 1,0 mg razmotrite snižavanje doze ako bolesnik razvije znakove ili simptome hipotenzije (vidjeti dijelove 4.4 i 4.5).
Pulmonary arterial hypertension (PAH)
Plućna arterijska hipertenzija (PAH)
In a clinical study the highest dose of Adempas (2.5 mg tablets three times daily) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 4 and 8 hours after intake.
U jednom kliničkom ispitivanju najviša doza lijeka Adempas (tablete od 2,5 mg tri puta na dan) pojačala je učinak na sniženje krvnog tlaka sublingualnog nitroglicerina (0,4 mg) uzetog 4 i 8 sati kasnije.
cellulose microcrystalline crospovidone (type B) hypromellose 5 cP magnesium stearate lactose monohydrate sodium laurilsulfate
celuloza, mikrokristalična krospovidon (tip B) hipromeloza 5 cP magnezijev stearat laktoza hidrat natrijev laurilsulfat
Table 6: Effects of riociguat in PATENT-1 on events of clinical worsening Clinical Worsening Events
Tablica 6: Učinci riocigvata u ispitivanju PATENT-1 na događaje koji pokazuju kliničko pogoršanje
Treatment-naïve patients (n=189) improved by 38 m, and pre-treated patients (n=191) by 36 m (ITT analysis, see table 4).
U bolesnika koji prethodno nisu bili liječeni (n=189) poboljšanje je iznosilo 38 m, a kod prethodno liječenih bolesnika (n=191) iznosilo je 36 m (ITT analiza, vidjeti tablicu 4).
respective laboratory parameters)
Anemija (uklj. odgovarajuće laboratorijske parametre)
29 to 83
29 do 83
The concomitant use of riociguat with other cumarin-derivatives (e.g. phenprocoumon) is also not expected to alter prothrombin time.
Ne očekuje se ni da će istodobna primjena riocigvata s drugim derivatima kumarina (npr. fenprokumonom) promijeniti protrombinsko vrijeme.
Concomitant administration of HAART combinations led to an increase in riociguat mean AUC of up to about 160% and to an approximate 20% increase in mean Cmax.
Istodobna primjena HAART kombinacija dovela je do povećanja srednje vrijednosti AUC-a riocigvata do oko 160% te približno 20%-tnog povećanja srednje vrijednosti Cmax.
-10 to 63
-10 do 63
Patients treated with riociguat showed significant improvement in Borg CR 10 dyspnoea score (mean change from baseline (SD): riociguat -0.4 (2), placebo 0.1 (2); p = 0.0022).
Bolesnici liječeni riocigvatom pokazali su značajno poboljšanje dispneje prema rezultatu na Borg CR 10 (srednja vrijednost promjene od početne vrijednosti (SD): riocigvat -0,4 (2), placebo 0,1 (2); p=0,0022).
When NO binds to sGC, the enzyme catalyses synthesis of the signalling molecule cyclic guanosine monophosphate (cGMP).
Kad se NO veže za sGC, taj enzim katalizira sintezu signalne molekule cikličkog gvanozin monofosfata (cGMP).
-10 to 61
-10 do 61
A randomised, double-blind, multi-national, placebo controlled, phase III study (PATENT-1) was conducted in 443 adult patients with PAH (riociguat individual dose titration up to 2.5 mg three times daily: n=254, placebo: n=126, riociguat “capped” dose titration (CT) up to 1.5 mg (exploratory dose arm, no statistical testing performed; n=63)).
Randomizirano, dvostruko slijepo, multinacionalno, placebom kontrolirano ispitivanje faze III (PATENT-1) bilo je provedeno u 443 odraslih bolesnika s PAH-om (titracija pojedinačne doze riocigvata do 2,5 mg tri puta na dan: n=254, placebo: n=126, riocigvat titriran do“ograničene” doze do 1,5 mg (krak koji je primao eksplorativnu dozu, bez provedenog statističkog testiranja; n=63).
In pulmonary arterial hypertension, studies with riociguat have been mainly performed in forms related to idiopathic or heritable PAH and PAH associated with connective tissue disease.
U plućnoj arterijskoj hipertenziji, ispitivanja s riocigvatom provedena su većinom u idiopatskom ili nasljednom PAH-u i PAH-u povezanom s bolešću vezivnog tkiva.
In this case, your doctor will prescribe you Adempas at the highest dose you are comfortable on. For some patients lower doses three times a day might be sufficient, the optimal dose will be selected by your doctor.
Nekim bolesnicima mogu biti dovoljne niže doze tri puta na dan, a optimalnu dozu odabrat će Vaš liječnik.
A randomised, double-blind, multi-national, placebo controlled, phase III study (CHEST-1) was conducted in 261 adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) (72%) or persistent or recurrent CTEPH after pulmonary endarterectomy (PEA; 28%).
Randomizirano, dvostruko slijepo, multinacionalno, placebom kontrolirano ispitivanje faze III (CHEST-1) bilo je provedeno u 261 odraslih bolesnika s inoperabilnom kroničnom tromboembolijskom plućnom hipertenzijom (KTEPH) (72%) ili perzistentnim ili recidivirajućim KTEPH-om nakon plućne endarterektomije (PEA; 28%).
Riociguat restores the NO-sGC-cGMP pathway resulting in a significant improvement of pulmonary vascular haemodynamics and an increase in exercise ability.
Riocigvat obnavlja put NO-sGC-cGMP, što rezultira značajnim poboljšanjem plućne vaskularne hemodinamike i poboljšanjem tolerancije fizičke aktivnosti.
Riociguat-treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0046; Stratified log-rank test) (see table 6).
U bolesnika liječenih riocigvatom kliničko pogoršanje nastupilo je značajno kasnije naspram bolesnika koji su primali placebo (p=0,0046; stratificirani log-rang test) (vidjeti tablicu 6).
The safety profile of Adempas in patients with CTEPH and PAH appeared to be similar, therefore adverse reactions identified from placebo controlled 12 and 16 weeks clinical studies are presented as pooled frequency in the table listed below (see table 1).
Čini se da Adempas ima sličan sigurnosni profil u bolesnika s KTEPH-om i PAH-om pa su stoga nuspojave utvrđene u placebom kontroliranim kliničkim ispitivanjima u trajanju od 12 i 16 tjedana prikazane objedinjenom učestalošću u niže navedenoj tablici (vidjeti tablicu 1).
Therefore use of Adempas is not recommended in these patients (see section 4.4).
Stoga se ne preporučuje primjena lijeka Adempas u ovih bolesnika (vidjeti dio 4.4).
Co-administration of the antacid aluminium hydroxide / magnesium hydroxide reduced riociguat mean AUC by 34% and mean Cmax by 56% (see section 4.2).
Istodobna primjena antacida aluminijevog hidroksida / magnezijevog hidroksida smanjila je srednju vrijednost AUC riocigvata za 34%, a srednju vrijednost Cmax za 56% (vidjeti dio 4.2).
To mitigate the risk of hypotension, consider dose reduction and monitoring for signs and symptoms of hypotension (see sections 4.2 and 4.5).
Kako bi se smanjio rizik od hipotenzije, razmotrite snižavanje doze i praćenje na znakove i simptome hipotenzije (vidjeti dijelove 4.2 i 4.5).
According to standard medical practice, expert assessment of operability should be done prior to treatment with riociguat.
Prema standardnoj medicinskoj praksi, prije liječenja riocigvatom mora se učiniti stručna procjena o mogućnosti izvođenja operativnog zahvata.
If a dose is missed, treatment should be continued with the next dose as planned.
Ako se propusti doza, liječenje se mora nastaviti sljedećom dozom prema rasporedu.
In vitro, abacavir, rilpivirine, efavirenz, ritonavir, cobicistat and elvitegravir inhibited CYP1A1 and the metabolism of riociguat in the order listed with abacavir as the strongest inhibitor.
In vitro, abakavir, rilpivirin, efavirenz, ritonavir, kobicistat i elvitegravir inhibiraju CYP1A1 i metabolizam riocigvata jačinom sukladnom navedenom redoslijedu, s abavakirom kao najjačim inhibitorom.
Very common: may affect more than 1 in 10 people - headache - dizziness - indigestion (dyspepsia) - swelling of limbs (oedema peripheral) - diarrhoea - feeling or being sick (nausea and vomiting)
Vrlo često: mogu se javiti u više od 1 na 10 osoba - glavobolja - omaglica - probavne tegobe (dispepsija) - oticanje udova (periferni edem) - proljev - mučnina ili povraćanje.
Riociguat did not potentiate the bleeding time caused by acetyl-salicylic acid or affect the platelet aggregation in humans.
Riocigvat nije pojačao učinak acetilsalicilatne kiseline na vrijeme krvarenja niti utjecao na agregaciju trombocita u ljudi.
Treatment should only be started and monitored by a doctor experienced in the treatment of CTEPH or PAH.
Liječenje mora započeti i nadzirati samo liječnik s iskustvom u liječenju KTEPH-a ili PAH-a.
Pre-treated patient population
Populacija prethodno liječenih bolesnika
Based on in vitro data riociguat and its main metabolite are substrates of the transporter proteins P-gp (P-glycoprotein) and BCRP (breast cancer resistance protein).
Na temelju in vitro podataka, riocigvat i njegov glavni metabolit supstrati su transportnih proteina P-gp (P-glikoproteina) i BCRP (proteina rezistencije karcinoma dojke).
The adverse reactions reported with Adempas are listed in the table below by MedDRA system organ class and by frequency.
Nuspojave zabilježene uz Adempas navedene su u sljedećoj tablici prema MedDRA klasifikaciji organskih sustava i učestalosti.
• coughing up blood (haemoptysis) (common side effect, may affect up to 1 in 10 people),
• iskašljavanje krvi (hemoptiza) (česta nuspojava, može se javiti u do 1 na 10 osoba)
Therefore, female patients at potential risk of pregnancy must use an effective method of contraception.
Stoga bolesnice reproduktivne dobi moraju koristiti učinkovitu kontracepciju.
The class of tyrosine kinase inhibitors was identified as potent inhibitors of CYP1A1, with erlotinib and gefitinib exhibiting the highest inhibitory potency in vitro.
Ustanovljeno je da je razred inhibitora tirozin kinaze jak inhibitor CYP1A1, među kojima su erlotinib i gefitinib pokazali najveću inhibicijsku potentnost in vitro.
There is no experience in patients with severe hepatic impairment (Child Pugh C); riociguat is contraindicated in these patients (see section 4.3).
Nema iskustva u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C); riocigvat je kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
There are no data in patients with severe hepatic impairment (classified as Child Pugh C).
Nema podataka za bolesnike s teškim oštećenjem funkcije jetre (klasificiranog kao Child-Pugh C).
Preclinical studies in animal models showed additive systemic blood pressure lowering effect when riociguat was combined with either sildenafil or vardenafil.
Pretklinička ispitivanja na životinjskim modelima pokazala su aditivni učinak riocigvata u kombinaciji sa sildenafilom ili vardenafilom na sniženje sistemskog krvnog tlaka.
It is recommended to monitor these patients for signs and symptoms of hypotension (see sections 4.2 and 4.4).
Preporučuje se praćenje tih bolesnika na znakove i simptome hipotenzije (vidjeti dijelove 4.2 i 4.4).
Crushed tablets
Zdrobljene tablete
Improvement in exercise capacity was accompanied by improvement in multiple clinically relevant secondary endpoints.
Poboljšanje kapaciteta podnošenja fizičkog napora bilo je praćeno višestrukim klinički važnim sekundarnim mjerama ishoda.
Patients with mild and moderate renal impairment were included in the pivotal studies.
Bolesnici s blagim do umjerenim oštećenjem funkcije bubrega bili su uključeni u glavna ispitivanja.
Film-coat: hydroxypropylcellulose, hypromellose 3 cP, propylene glycol (E 1520) and titanium dioxide (E 171).
Film ovojnica: hidroksipropilceluloza, hipromeloza 3cP, propilenglikol (E 1520) i titanijev dioksid (E 171)
In CTEPH, the blood vessels of the lung are blocked or narrowed with blood clots.
Kod KTEPH-a, krvne žile pluća začepljene su ili sužene krvnim ugrušcima.