natgillin/translations-raw huggingface dataset:
What Revatio contains - The active substance is sildenafil (as sildenafil citrate).
Djelatna tvar je sildenafil (u obliku sildenafilcitrata).
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96 %, 91 % and 82 %, respectively.
U ovoj je populaciji jednogodišnje preživljenje procijenjeno Kaplan-Meierovom metodom iznosilo 96%, dvogodišnje 91%, a trogodišnje 82%.
Each pack also contains a polypropylene measuring cup (graduated to indicate 30 ml), polypropylene oral dosing syringe (3 ml) with HDPE plunger and a LDPE press-in bottle adaptor.
Svako pakiranje sadrži i polipropilensku odmjernu čašicu (kalibriranu na 30 ml), polipropilensku štrcaljku za usta (3 ml) s klipom od polietilena visoke gustoće (HDPE) i nastavak koji se utisne u bocu od polipropilena niske gustoće (LDPE).
In clinical trials side effects reported commonly (may affect up to 1 in 10 people) by patients with pulmonary arterial hypertension were facial flushing and nausea.
Nuspojave koje su u kliničkim ispitivanjima često prijavili (mogu se javiti u do 1 na 10 osoba) bolesnici s plućnom arterijskom hipertenzijom bile su navale crvenila i mučnina.
Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension (PAH) who were already receiving and stable on oral Revatio 20 mg three times per day.
Ispitivanje A1481262 je bilo otvoreno kliničko ispitivanje jednokratne doze lijeka, u jednom centru, kako bi se ocijenila sigurnost, podnošljivost i farmakokinetika jedne intravenske doze sildenafila (10 mg) primijenjenog u obliku bolusne injekcije u bolesnika s plućnom arterijskom hipertenzijom (PAH) koji su već primali i bili stabilni na peroralnoj terapiji lijekom Revatio u dozi od 20 mg tri puta na dan.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA MALOM UNUTARNJEM PAKIRANJU
Replace the cap on the bottle, leaving the bottle adaptor in place.
Vratite zatvarač na bocu, a nastavak za bocu ostavite na mjestu.
No interactions were observed between sildenafil (100 mg single oral dose) and acenocoumarol.
Nisu zabilježene interakcije između sildenafila (jedna peroralna doza od 100 mg) i acenokumarola.
The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Cmax N-dezmetil metabolita iznosio je 30,8 ng/ml, a AUC(0-8) 147 ng.h/ml.
Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with PAH who were already receiving and stable on oral Revatio 20 mg TID.
Ispitivanje A1481262 je bilo otvoreno kliničko ispitivanje jednokratne doze lijeka, u jednom centru, kako bi se ocijenila sigurnost, podnošljivost i farmakokinetika jedne intravenske doze sildenafila (10 mg) primijenjenog u obliku bolusne injekcije u bolesnika s PAH-om koji su već primali i bili stabilni na peroralnoj terapiji lijekom Revatio u dozi od 20 mg TID.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section 4.4).
Istodobna primjena sildenafila u bolesnika koji uzimaju alfa-blokatore može u osjetljivih osoba dovesti do simptomatske hipotenzije (vidjeti dio 4.4).
figure 2
slika 2
In healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of oral sildenafil or its principal circulating metabolite.
Za preporuke o doziranju vidjeti dio 4.2. U zdravih muških dobrovoljaca nije bilo dokaza o utjecaju azitromicina (500 mg na dan tijekom 3 dana) na AUC, Cmax, Tmax, konstantu brzine eliminacije niti kasniji poluvijek sildenafila ili njegovog glavnog metabolita u cirkulaciji nakon peroralne primjene.
Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Nakon pripreme, oralna suspenzija se mora primjenjivati isključivo pomoću štrcaljke za usta priložene u svakom pakiranju lijeka.
Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of Revatio given three times a day, or placebo.
Ispitanici su razvrstani u jednu od tri skupine koje su primale sildenafil: nisku (10 mg), srednju (10-40 mg) ili visoku dozu (20-80 mg) lijeka Revatio tri puta na dan, ili u skupinu koja je primala placebo.
No significant interactions were shown when oral sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Nisu opažene značajne interakcije kada je sildenafil (50 mg) primijenjen peroralno istodobno s tolbutamidom (250 mg) ili varfarinom (40 mg), koji se oba metaboliziraju pomoću CYP2C9.
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 4).
Vratite zatvarač na bocu i snažno je tresite najmanje 30 sekundi. (slika 4)
The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.
Sljedeće ozbiljne nuspojave prijavljene su često (mogu se javiti u do 1 na 10 osoba): upala pluća, srčano zatajenje, zatajenje desnog srca, šok povezan sa srcem, visoki krvni tlak u plućima, bol u prsnom košu, nesvjestica, infekcija dišnih puteva, bronhitis, virusne infekcije u trbuhu i crijevima, infekcije mokraćnih puteva i zubni karijes.
Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
Bolesnici su randomizirani u jednu od četiri terapijske skupine da primaju placebo, sildenafil u dozi od 20 mg, sildenafil u dozi od 40 mg ili sildenafil u dozi od 80 mg tri puta na dan.
A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steady-state sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Analiza podataka o populacijskoj farmakokinetici sildenafila iz ispitivanja u odraslih bolesnika s PAH-om kod kojih se kao osnovni lijek primjenjivao bosentan (62,5 mg - 125 mg dva puta na dan) pokazala je povećanje 20% (95% CI: 9,8 - 30,8) AUC bosentana kod istodobne primjene sildenafila u stanju dinamičke ravnoteže (20 mg tri puta na dan) u odnosu na ono zapaženo u zdravih dobrovoljaca kada se istodobno primjenjivao s 80 mg sildenafila tri puta na dan (vidjeti dijelove 4.4 i 5.1).
The most common adverse reactions that occurred (with a frequency ≥ 1 %) in Revatio patients (combined doses) and with a frequency > 1 % over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Najčešće nuspojave su (sa učestalošću ≥ 1%) u bolesnika liječenih lijekom Revatio (u kombiniranom liječenju) i sa učestalošću > 1% u odnosu na bolesnike na placebu bile su povišena temperatura, infekcija gornjih dišnih puteva (svaki 11,5%), povraćanje (10,9%), pojačana erekcija (uključujući spontanu erekciju spolovila u muških bolesnika) (9%), mučnina, bronhitis (svaki 4,6%), faringitis (4,0%), curenje iz nosa (3,4%) i pneumonija, rinitis (svaki 2,9%).
Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 2).
Vratite zatvarač na bocu i snažno je tresite najmanje 30 sekundi. (slika 2)
The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil (20 mg three times a day) and placebo (13.62 m (95% CI: -3.89 to 31.12) and 14.08 m (95% CI: -1.78 to 29.95), respectively).
Rezultati pokazuju da nema značajne razlike u srednjoj vrijednosti promjene u 6MWD-u u odnosu na početne vrijednosti između sildenafila (20 mg tri puta na dan) i placeba (13,62 m (95% CI: -3,89 do 31,12) i 14,08 m (95% CI: -1,78 do 29,95)).
Instructions to reconstitute the oral suspension It is recommended that your pharmacist reconstitutes (makes up) the oral suspension before giving it to you.
Preporučuje se da Vaš ljekarnik pripremi (pomiješa) oralnu suspenziju prije nego što Vam izda lijek.
At single oral doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Kod primjene pojedinačnih peroralnih doza od 200 mg povećala se incidencija nuspojava (glavobolja, navale crvenila, omaglica, dispepsija, kongestija nosa i promjene vida).
Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g).
Sildenafil nije imao klinički značajan utjecaj na koncentracije oralnih kontraceptiva u plazmi (etinilestradiol 30 µg i levonorgestrel 150 µg).
In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Općenito, bilo kakva prilagodba doze smije se primijeniti samo nakon pažljive procjene koristi i rizika.
Revatio 20 mg film-coated tablets
Revatio 20 mg filmom obložene tablete
The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due todisrupted airflow.
Za sljedeće ozbiljne nuspojave se smatra da su povezane s liječenjem i prijavljene su manje često (mogu se javiti u do 1 na 100 osoba): alergijska reakcija (kao što je kožni osip, oticanje lica, usana i jezika, zviždanje pri disanju, poteškoće s disanjem ili gutanjem), konvulzije, nepravilan rad srca, oštećenje sluha, nedostatak zraka, upala probavnog trakta, zviždanje zbog poremećenog protoka zraka.
Revatio 0.8 mg/ml solution for injection Sildenafil
Revatio 0,8 mg/ml otopina za injekciju sildenafil
A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
Analiza podataka o populacijskoj farmakokinetici sildenafila u odraslih bolesnika s PAH-om iz kliničkih ispitivanja, uključujući 12-tjedno ispitivanje za procjenu djelotvornosti i sigurnosti peroralnog sildenafila 20 mg tri puta dnevno koji se dodaje stabilnoj dozi bosentana (62,5 mg - 125 mg dvaput dnevno) pokazala je da se izloženost sildenafilu smanjila kod istodobne primjene bosentana, slično onome što je primijećeno u zdravih dobrovoljaca (vidjeti dijelove 4.4 i 5.1).
When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction (see section 4.4).
Kad propisuju sildenafil, liječnici moraju pažljivo razmotriti hoće li blagi do umjereni vazodilatacijski učinci sildenafila štetno utjecati na bolesnike s određenim podležećim stanjima, kao što su hipotenzija, gubitak tekućine, teška opstrukcija istisnog dijela lijeve klijetke ili autonomna disfunkcija (vidjeti dio 4.4).
In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92 %, 81 % and 74 %, respectively.
U ovoj je populaciji jednogodišnje preživljenje procijenjeno Kaplan-Meierovom metodom iznosilo 92%, dvogodišnje 81%, a trogodišnje 74%.
The known adverse events headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients.
Učestalost poznatih nuspojava: glavobolje, crvenila praćenog osjećajem užarenosti ili vrućine, boli u ekstremitetima i edema bila je veća u bolesnika liječenih sildenafilom/epoprostenolom u usporedbi s bolesnicima koji su primali placebo/epoprostenol.
Efficacy of oral sildenafil in adult patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions.
Djelotvornost u odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 278 bolesnika s primarnom plućnom hipertenzijom, PAH-om povezanim s bolešću vezivnog tkiva i PAH-om koji je nastao nakon kirurškog popravka prirođenih srčanih lezija.
In a study of healthy volunteers sildenafil at steady state (80 mg three times a day) resulted in a 50 % increase in bosentan AUC (125 mg twice daily).
U ispitivanju provedenom sa zdravim dobrovoljcima sildenafil je u stanju dinamičke ravnoteže (80 mg tri puta na dan) povećao AUC bosentana (125 mg dva puta na dan) za 50%.
For instructions on constitution of the medicinal product before administration, see section 6.6.
Za upute o pripremi lijeka prije primjene vidjeti dio 6.6.
BOTTLE
BOCA
Shake the closed bottle of constituted oral suspension vigorously for a minimum of 10 seconds before use.
Prije uporabe, zatvorenu bocu pripremljene oralne suspenzije snažno tresite najmanje 10 sekundi.
- The other ingredients are: Powder for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring
Drugi sastojci su: prašak za oralnu suspenziju: sorbitol, bezvodna citratna kiselina, sukraloza, natrijev citrat, ksantanska guma, titanijev dioksid (E171), natrijev benzoat (E211), bezvodni koloidni silicijev dioksid.
Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10 %, 4 % and 15 % for the low, medium and high dose groups respectively.
Poboljšanje srčanog indeksa opaženo je u sve tri skupine liječene sildenafilom u odnosu na placebo: 10% u skupini koja je primala nisku dozu, 4% u skupini koja je primala srednju dozu i 15% u skupini koja je primala visoku dozu sildenafila.
Film coat: hypromellose, titanium dioxide (E171), lactose monohydrate, glycerol triacetate
Film ovojnica: hipromeloza, titanijev dioksid (E171), laktoza hidrat, glicerol triacetat.
Hypromellose Titanium dioxide (E171) Lactose monohydrate Glycerol triacetate
Film ovojnica: hipromeloza titanijev dioksid (E171) laktoza hidrat glicerol triacetat
figure 9
slika 9
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of oral sildenafil.
Sok od grejpa je slab inhibitor CYP3A4 u stijenci crijeva i može izazvati malo povećanje plazmatskih koncentracija peroralno primijenjenog sildenafila.
CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
Činilo se da induktori CYP3A4 značajno utječu na farmakokinetiku sildenafila u bolesnika s plućnom arterijskom hipertenzijom, što je potvrđeno u in vivo ispitivanju interakcije s induktorom CYP3A4 bosentanom.
In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
U ta dva placebom kontrolirana ispitivanja štetni događaji su općenito bili blagi do umjereni u težini.
Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomized, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 103 klinički stabilna bolesnika s PAH-om (WHO FC II i III) liječenih bosentanom najmanje tri mjeseca.
• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
lijekove koji sadrže nitrate ili donore dušikovog oksida poput amil nitrata.
Common gastritis, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
Poremećaji probavnog sustava vrlo često proljev, dispepsija često gastritis, gastroezofagealna refluksna bolest, hemoroidi, distenzija abdomena, suha usta
For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg (1 ml of reconstituted suspension) three times a day and for patients > 20 kg is 20 mg (2 ml of reconstituted suspension) three times a day.
Za pedijatrijske bolesnike u dobi od 1 do 17 godina preporučena doza u bolesnika tjelesne težine ≤ 20 kg iznosi 10 mg (1 ml rekonstituirane suspenzije) tri puta na dan, a u bolesnika tjelesne težine > 20 kg ona iznosi 20 mg (2 ml rekonstituirane suspenzije) tri puta na dan.
Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the pharmacokinetics of sildenafil.
Istodobna primjena oralnih kontraceptiva (etinilestradiol 30 µg i levonorgestrel 150 µg) nije utjecala na farmakokinetiku sildenafila.
Note: Expires 30 days after reconstitution.
Napomena: Datum isteka roka valjanosti je 30 dana od dana pripreme.
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment.
U dobrovoljaca s blagom do umjerenom cirozom jetre (Child-Pugh stadij A i B) klirens sildenafila je bio smanjen, što je rezultiralo povećanjem AUC (85%) i Cmax (47%) u usporedbi s dobrovoljcima bez oštećenja jetre podudarnima s obzirom na dob.
CYP3A4 inducers seemed to have a substantial impact on the oral pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
Činilo se da induktori CYP3A4 značajno utječu na farmakokinetiku peroralno primijenjenog sildenafila u bolesnika s plućnom arterijskom hipertenzijom, što je potvrđeno u in vivo ispitivanju interakcije s induktorom CYP3A4 bosentanom.
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63 % decrease of sildenafil AUC.
Istodobna primjena bosentana (umjerenog induktora CYP3A4, CYP2C9, a možda i CYP2C19) u dozi od 125 mg dva puta na dan sa sildenafilom u dozi od 80 mg tri puta na dan (u stanju dinamičke ravnoteže) tijekom 6 dana u zdravih dobrovoljaca rezultirala je smanjenjem AUC sildenafila od 63%.
A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95 % CI: -5.7, -2.1) (p = 0.00003).
Opažena je srednja, placebo korigirana vrijednost učinka liječenja od -3,9 mmHg u korist sildenafila (95% CI: -5,7; -2,1) (p = 0,00003).
The mean absolute oral bioavailability is 41 % (range 25-63 %).
Prosječna apsolutna bioraspoloživost nakon peroralne primjene je 41% (raspon 25-63%).
Discard any remaining oral suspension 30 days after constitution.
Baciti preostalu oralnu suspenziju 30 dana nakon pripreme.
Do not use this medicine after the expiry date which is stated on the bottle after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci iza "Rok valjanosti".
Sildenafil (100 mg single oral dose) did not affect the steady state pharmacokinetics of the HIV protease inhibitor saquinavir, which is a CYP3A4 substrate/inhibitor.
Sildenafil (jedna peroralna doza od 100 mg) nije utjecao na farmakokinetiku inhibitora HIV proteaze sakvinavira, koji je supstrat/inhibitor CYP3A4, u stanju dinamičke ravnoteže.
Revatio 20 mg film-coated tablets Sildenafil
Revatio 20 mg filmom obložene tablete sildenafil
Replace the cap on the bottle.
Vratite zatvarač na bocu.
Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Revatio je (u peroralnim oblicima) indiciran za liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom funkcionalnog stupnja II i III prema klasifikaciji Svjetske zdravstvene organizacije (SZO), a u cilju poboljšanja tjelesne sposobnosti.
Revatio 0.8 mg/ml solution for injection
Revatio 0,8 mg/ml otopina za injekciju
The mean absolute oral bioavailability for sildenafil is 41 % (range 25-63 %).
Srednja vrijednost apsolutne bioraspoloživosti sildenafila nakon peroralne primjene je 41% (raspon 25-63%).
What you need to know before you are given Revatio
Što morate znati prije nego počnete primati Revatio
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Sildenafil (50 mg) nije pojačao hipotenzivne učinke alkohola u zdravih dobrovoljaca sa srednjom vrijednošću najviše razine alkohola u krvi od 80 mg/dl.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment.
U dobrovoljaca s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) klirens sildenafila je bio smanjen, što je rezultiralo srednjom vrijednošću povećanja AUC od 100%, a Cmax od 88% u usporedbi s dobrovoljcima bez oštećenja bubrega podudarnima s obzirom na dob.
The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Analiza populacijske farmakokinetike u bolesnika s plućnom arterijskom hipertenzijom upućuje na to da istodobna primjena beta-blokatora u kombinaciji sa supstratima CYP3A4 može rezultirati dodatnim povećanjem izloženosti sildenafilu u usporedbi s primjenom samo supstrata CYP3A4.
Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) funkcionalnog stupnja II i III prema klasifikaciji Svjetske zdravstvene organizacije (SZO), u cilju poboljšanja tjelesne sposobnosti.
Refer to the patient leaflet for more detailed instructions for use.
Za detaljnije upute za uporabu, pročitajte uputu o lijeku.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
U tri specifična ispitivanja interakcija, lijekovi alfa-blokator doksazosin (4 mg i 8 mg) i sildenafil (25 mg, 50 mg ili 100 mg) su istodobno primijenjeni bolesnicima s benignom hiperplazijom prostate (BHP), stabiliziranima na terapiji doksazosinom.