FrancophonIA/ELRC3.0 huggingface dataset:
English: These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of ADCIRCA.
Croatian: "nepoznato", jer se učestalost u bolesnika s PAH-om ne može procijeniti iz dostupnih podataka, ili im je dodijeljena kategorija učestalosti na temelju podataka iz pivotalnog, placebom kontroliranog ispitivanja lijeka ADCIRCA.
English: Also included in the table are some adverse reactions which have been reported in clinical studies and/or post marketing with tadalafil in the treatment of male erectile dysfunction.
Croatian: U tablicu su uključene i neke nuspojave koje su prijavljene u kliničkim ispitivanjima i/ili nakon stavljanja u promet tadalafila za liječenje muške erektilne disfunkcije.
English: The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort)
Croatian: Sljedeće nuspojave prijavljene su vrlo često u bolesnika koji uzimaju lijek ADCIRCA (mogu se javiti u više od 1 na 10 osoba): glavobolja, crvenilo praćeno osjećajem vrućine, kongestija sinusa i nosa (začepljenost nosa), mučnina, probavne smetnje (uključujući bolove ili nelagodu u trbuhu), bolovi u mišićima, bol u leđima i bol u udovima (uključujući i nelagodu u udovima).
English: CYP2C9 substrates (e.g.R-warfarin)
Croatian: Supstrati izoenzima CYP2C9 (npr. R-varfarin)
English: Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Croatian: Rezultati su uglavnom bili dosljedni u podskupinama prema dobi, spolu, etiologiji PAH-a te funkcionalnom stupnju prema SZO-u i 6MWD-u na početku ispitivanja.
English: Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients with erectile dysfunction.
Croatian: Zdravim su ispitanicima primijenjene pojedinačne doze do 500 mg, a bolesnicima s erektilnom disfunkcijom višestruke dnevne doze do 100 mg.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Croatian: 4.2 Doziranje i način primjene Liječenje mora započeti i nadzirati isključivo liječnik s iskustvom u liječenju PAH-a.
English: Seizures5, Transient amnesia5
Croatian: napadaji5, prolazna amnezija5
English: The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Croatian: Nisu ispitivane sigurnost i djelotvornost istovremene primjene tadalafila s drugim inhibitorima PDE5 ili drugim lijekovima za erekcijsku disfunkciju.
English: In patients who are taking alpha1 blockers concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
Croatian: U bolesnika koji uzimaju blokatore alfa1-receptora istodobna primjena tadalafila može u nekim slučajevima dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
English: Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Croatian: (NAION, engl. non-arteritic anterior ischaemic optic neuropathy), bez obzira na to je li ta epizoda povezana s prethodnim izlaganjem inhibitorima PDE5 (vidjeti dio 4.4).
English: In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Croatian: U dva od tih ispitivanja opaženo je smanjenje broja i koncentracije spermatozoida povezano s liječenjem tadalafilom, ali nije vjerojatno da bi ono bilo klinički značajno.
English: Palpitations2, 5
Croatian: Srčani poremećaji palpitacije2, 5
English: The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
Croatian: Najčešće prijavljene nuspojave, koje su se javile u ≥ 10% bolesnika u skupini koja je primala tadalafil u dozi od 40 mg, bile su glavobolja, mučnina, bol u leđima, dispepsija, crvenilo praćeno osjećajem užarenosti ili vrućine, mialgija, nazofaringitis i bol u udovima.
English: Dizziness has been reported.
Croatian: Prijavljena je omaglica.
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with ADCIRCA.
Croatian: U sljedećoj su tablici navedene nuspojave prijavljene tijekom placebom kontroliranog kliničkog ispitivanja u bolesnika s PAH-om liječenih lijekom ADCIRCA.
English: Additionally, improvements compared to placebo were observed with tadalafil 40 mg in the physical functioning, role-physical, bodily pain, general health, vitality and social functioning domains of the SF-36.
Croatian: Osim toga, u odnosu na placebo su kod primjene tadalafila u dozi od 40 mg uočena poboljšanja u sljedećim domenama upitnika SF-36: fizičkom funkcioniranju, ograničenju zbog fizičkih tegoba, tjelesnim bolovima, općem zdravlju, vitalnosti i socijalnom funkcioniranju.
English: They are in the shape of almonds and have "4467" marked on one side.
Croatian: "4467" na jednoj strani.
English: Cytochrome P450 Inducers
Croatian: Induktori citokroma P450
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration.
Croatian: Antagonisti receptora endotelina-1 (npr. bosentan) Bosentan (125 mg dvaput na dan), supstrat CYP2C9 i CYP3A4 i umjeren induktor CYP3A4, CYP2C9, a možda i CYP2C19, je nakon istodobne primjene višestrukih doza smanjio sistemsku izloženost tadalafilu (40 mg jedanput na dan) za 42%, a Cmax za 27%.
English: In the pivotal placebo-controlled study of ADCIRCA for the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
Croatian: U pivotalnom placebom kontroliranom ispitivanju lijeka ADCIRCA u liječenju PAH-a ukupno su 323 bolesnika liječena lijekom ADCIRCA u dozama od 2,5 mg do 40 mg jedanput na dan, dok su
English: How to take ADCIRCA
Croatian: Kako uzimati lijek ADCIRCA
English: (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Croatian: (4) Klinički izraz koji nije iz MedDRA terminologije, a obuhvaća izvješća o neuobičajenom/prekomjernom menstrualnom krvarenju kao što su menoragija, metroragija,
English: If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Croatian: Ako se propisuje tadalafil, liječnik koji ga propisuje mora pomno procijeniti koristi i rizike liječenja za svakog pojedinog bolesnika.
English: Anti-hypertensives (including Calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Croatian: Istodobna primjena doksazosina (4 i 8 mg na dan) i tadalafila (dnevna doza od 5 mg i 20 mg u jednoj dozi) značajno pojačava učinak ovog alfa-blokatora na sniženje krvnog tlaka.
English: 3 years.
Croatian: 6.3 Rok valjanosti 3 godine.
English: Ritonavir (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) single dose exposure (AUC) 2-fold with no change in Cmax.
Croatian: Ritonavir (200 mg dvaput na dan), inhibitor CYP3A4, CYP2C9, CYP2C19 i CYP2D6, je dvostruko povećao izloženost tadalafilu (AUC) nakon primjene jedne doze (20 mg), bez promjena Cmax.
English: Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Croatian: Ispitivanja in vitro su pokazala da je tadalafil selektivan inhibitor PDE5.
English: PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
Croatian: PDE5 je enzim koji se nalazi u glatkom mišičju šupljikavog tijela, glatkom mišičju krvnih žila i unutarnjih organa, mišićima kostura, trombocitima, bubrezima, plućima i malom mozgu.
English: Only tadalafil 40 mg achieved the protocol defined level of significance with a placeboadjusted median increase in 6MWD of 26 metres (p=0.0004; 95 % CI: 9.5, 44.0; Pre-specified Hodges-Lehman method) (mean 33 metres, 95 % CI: 15.2, 50.3).
Croatian: 26 metara (p = 0,0004; 95% CI: 9,5; 44,0; prethodno definirana Hodges-Lehmanova metoda) (srednja vrijednost 33 metra, 95% CI: 15,2; 50,3).
English: CYP1A2 substrates (e.g. theophylline)
Croatian: Supstrati izoenzima CYP1A2 (npr. teofilin)
English: Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Croatian: Tadalafil također djeluje > 10 000 puta jače na PDE5
English: Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.
Croatian: S obzirom da ne postoje klinički podaci o primjeni tadalafila u bolesnika s okluzivnom bolešću vena, ne preporučuje se primjena tadalafila u takvih bolesnika.
English: Film-coated tablet core lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
Croatian: Jezgra filmom obložene tablete laktoza hidrat umrežena karmelozanatrij hidroksipropilceluloza mikrokristalična celuloza natrijev laurilsulfat magnezijev stearat
English: The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23 % vs. 21 %).
Croatian: Udio bolesnika kojima se do 16. tjedna poboljšao funkcionalni stupanj prema SZO-u bio je podjednak u skupini koja je primala tadalafil u dozi od 40 mg i skupini koja je primala placebo (23% u odnosu na 21%).
English: > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Croatian: Tadalafil djeluje > 10 000 puta jače na PDE5 nego na PDE3, enzim koji se nalazi u srcu i krvnim žilama.
English: Dyspepsia (including abdominal pain/discomfort3)
Croatian: (uključujući i bol/nelagodu u abdomenu3)
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %.
Croatian: Ritonavir (500 mg ili 600 mg dvaput na dan) je povećao izloženost tadalafilu (AUC) nakon primjene jedne doze za 32%, a smanjio Cmax za 30%.
English: No improvements were observed in the role emotional and mental health domains of the SF36.
Croatian: Nisu zabilježena poboljšanja u domenama upitnika SF-36: ograničenje zbog emocionalnih tegoba i psihičko zdravlje.
English: (3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort.
Croatian: (3) Obuhvaća MedDRA termine: nelagoda u abdomenu, bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i nelagoda u želucu.
English: How to store ADCIRCA
Croatian: Kako čuvati lijek ADCIRCA
English: - Patients with clinically significant aortic and mitral valve disease - Patients with pericardial constriction - Patients with restrictive or congestive cardiomyopathy - Patients with significant left ventricular dysfunction - Patients with life-threatening arrhythmias - Patients with symptomatic coronary artery disease - Patients with uncontrolled hypertension.
Croatian: - bolesnici sa značajnom disfunkcijom lijeve klijetke - bolesnici sa životno ugrožavajućim aritmijama - bolesnici sa simptomatskom bolešću koronarnih arterija
English: Suomi/Finland
Croatian: Belgique/België/Belgien
English: (6) Headache was the most commonly reported adverse reaction.
Croatian: (6) Najčešće prijavljena nuspojava bila je glavobolja.
English: - In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Croatian: U kliničkim se ispitivanjima pokazalo da tadalafil pojačava hipotenzivne učinke nitrata.
English: ADCIRCA has negligible influence on the ability to drive or use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima ADCIRCA zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Croatian: Stoga je kontraindicirana primjena tadalafila u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.3).
English: In patients with severe renal impairment the use of tadalafil is not recommended (see sections 4.4 and 5.2).
Croatian: U bolesnika s teškim oštećenjem bubrega primjena tadalafila se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).
Croatian: Stoga je kontraindicirana primjena tadalafila u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.5).
English: P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Croatian: Tadalafil (40 mg jedanput na dan) nije imao klinički značajnog učinka na farmakokinetiku digoksina.
English: ADCIRCA is supplied as a 20 mg tablet.
Croatian: ADCIRCA je dostupna u obliku tablete od 20 mg.
English: Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88 % and Cmax by 46 %, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Croatian: Induktor izoenzima CYP3A4 rifampicin (600 mg na dan) smanjio je AUC tadalafila za 88%, a Cmax za 46% u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila (10 mg).
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil is not recommended (see sections 4.4 and 5.2).
Croatian: Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga primjena tadalafila ne preporučuje (vidjeti dijelove 4.4 i 5.2).
English: OTHER Mon, Tue, Wed, Thu, Fri, Sat, Sun.
Croatian: Pon, Uto, Sri, Čet, Pet, Sub, Ned
English: Chest pain2 (1) Events not reported in registration studies and cannot be estimated from the available data.
Croatian: (1) Događaji koji nisu prijavljeni u ispitivanjima u svrhu registracije lijeka i učestalost im se ne može se procijeniti iz dostupnih podataka.
English: riociguat.
Croatian: - riocigvat
English: Common (may affect up to 1 in 10 people) - blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.
Croatian: - zamagljen vid, nizak krvni tlak, krvarenje iz nosa, povraćanje, pojačano ili neuobičajeno krvarenje iz maternice, oticanje lica, refluks kiseline, migrena, nepravilno kucanje srca i nesvjestica.
English: Urticaria5, Hyperhydrosis (sweating)5
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija5, hiperhidroza (znojenje)5
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Croatian: Dokazana je djelotvornost u idiopatskoj plućnoj arterijskoj hipertenziji (IPAH) kao i u plućnoj arterijskoj hipertenziji povezanoj s kolagenozom krvnih žila.
English: The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
Croatian: U klinička ispitivanja PAH-a nisu bile uključene sljedeće skupine bolesnika s bolestima srca i krvnih žila:
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Croatian: rezultata u 48. tjednu izračunata metodom najmanjih kvadrata iznosila je -51,0 metar (m) u skupini koja je primala placebo, u usporedbi s -64,7 m u skupini liječenoj tadalafilom u dozi od 0,3 mg/kg (p = 0,307) odnosno -59,1 m u skupini liječenoj tadalafilom u dozi od 0,6 mg/kg (p = 0,538).
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Croatian: Nakon primjene doze od 10 mg, izloženost tadalafilu (AUC) u ispitanika s blagim i umjerenim oštećenjem jetre (Child-Pugh stadij A i B) usporediva je s izloženošću u zdravih ispitanika.
English: - any heart problems other than your pulmonary hypertension - problems with your blood pressure - any hereditary eye disease - an abnormality of red blood cells (sickle cell anaemia) - cancer of the bone marrow (multiple myeloma) - cancer of the blood cells (leukaemia) - any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours - a serious liver problem - a serious kidney problem.
Croatian: - rak koštane srži (multipli mijelom) - rak krvnih stanica (leukemiju) - neku deformaciju penisa ili neželjenu ili dugotrajnu erekciju koja ne prolazi dulje od 4 sata - ozbiljne tegobe s jetrom - ozbiljne tegobe s bubrezima.
English: The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction.
Croatian: Nuspojave su uključene u tablicu na temelju podataka prikupljenih nakon stavljanja lijeka u promet, odnosno u kliničkim ispitivanjima primjene tadalafila u liječenju erektilne disfunkcije.
English: Additionally, 6 minute walk distance and WHO functional class status appeared to be stable in those treated with tadalafil for 1 year.
Croatian: Osim toga, u bolesnika liječenih tadalafilom godinu dana 6-minutna hodna pruga i funkcionalni status prema SZO-u bili su stabilni.
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).
Croatian: Djelotvornost tadalafila u bolesnika koji se već liječe bosentanom nije u potpunosti dokazana (vidjeti dijelove 4.5 i 5.1).
English: PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine.
Croatian: Pokazalo se da inhibitori PDE5, kao što je ADCIRCA, pojačavaju učinak toga lijeka na sniženje krvnog tlaka.
English: Warnings and precautions Talk to your doctor before taking ADCIRCA.
Croatian: Obratite se svom liječniku prije nego uzmete lijek ADCIRCA.
English: ADCIRCA 20 mg film-coated tablets Tadalafil
Croatian: ADCIRCA 20 mg filmom obložene tablete tadalafil
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and, therefore, dosing of tadalafil is not recommended.
Croatian: Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga primjena tadalafila ne preporučuje.
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22 %.
Croatian: Ketokonazol (u dozi od 400 mg na dan) je povećao izloženost (AUC) tadalafilu nakon jedne doze od 20 mg četverostruko, a Cmax za 22%.
English: Angioedema
Croatian: angioedem
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects after a 10 mg dose.
Croatian: U bolesnika sa šećernom bolešću je izloženost tadalafilu (AUC) nakon doze od 10 mg bila oko 19%
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.4 and 5.1).
Croatian: Djelotvornost tadalafila u bolesnika koji se već liječe bosentanom nije u potpunosti dokazana (vidjeti dijelove 4.4 i 5.1).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: ADCIRCA contains lactose If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako znate da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: No dose adjustment is warranted.
Croatian: Nije potrebno prilagođavati dozu.
English: Patients with severe hepatic cirrhosis (Child-Pugh Class C) have not been studied and therefore dosing of tadalafil in these patients is not recommended.
Croatian: Bolesnici s teškom cirozom jetre (Child-Pugh stadij C) nisu ispitivani te se stoga u tih bolesnika primjena tadalafila ne preporučuje.
English: Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Croatian: Dok ste trudni ili dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: Changes in the Borg dyspnoea score were small and non-significant with both placebo and tadalafil 40 mg.
Croatian: Promjene rezultata na ljestvici zaduhe po Borgu bile su i kod primjene placeba i kod primjene tadalafila u dozi od 40 mg male te nisu bile značajne.
English: ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Croatian: funkcionalnog stupnja II i III prema klasifikaciji SZO-a, u cilju poboljšanja tjelesne sposobnosti (vidjeti dio 5.1).
English: Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Croatian: Liječnici moraju pažljivo razmotriti hoće li ti vazodilatacijski učinci nepovoljno djelovati na bolesnike s određenim komorbiditetima, kao što su teška opstrukcija istisnog dijela lijeve klijetke,
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Croatian: Nije bilo farmakokinetičkih interakcija kada se tadalafil 10 mg primjenjivao s teofilinom (neselektivnim inhibitorom fosfodiesteraze).
English: Eli Lilly Holdings Limited Eesti filiaal Tel: +372 6 817 280
Croatian: Eesti filiaal Tel: +372 6 817 280
English: The clinical relevance of this finding is uncertain.
Croatian: Nije sigurno je li ovaj nalaz od kliničkog značaja.
English: NAME OF THE MEDICINAL PRODUCT ADCIRCA 20 mg tablets tadalafil
Croatian: NAZIV LIJEKA ADCIRCA 20 mg tablete tadalafil
English: Method of administration ADCIRCA is for oral use.
Croatian: ADCIRCA je namijenjena za peroralnu primjenu.
English: In healthy female and male subjects following single and multiple-doses of tadalafil, no clinically relevant differences in exposure were observed.
Croatian: Nisu zabilježene klinički značajne razlike u izloženosti između zdravih ženskih i muških ispitanika nakon primjene jedne i višekratnih doza tadalafila.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80 kg male), but in some subjects, postural dizziness and orthostatic hypotension were observed.
Croatian: (20 mg) nije povećao prosječno sniženje krvnog tlaka izazvano alkoholom (0,7 g/kg ili približno
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Croatian: (uključujući kongestiju nosa, kongestiju sinusa i rinitis)