FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no effect of a single dose of avanafil on amlodipine plasma levels.
Croatian: Jednokratna doza avanafila nije imala učinka na razine amlodipina u plazmi.
English: Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure.
Croatian: Iako specifične interakcije nisu bile ispitivane, drugi inhibitori CYP3A4, uključujući sok od grejpa, vjerojatno bi povećali izloženost avanafilu.
English: Alpha-blockers
Croatian: Alfa blokatori
English: Further, the metabolites of avanafil (M4, M16 and M27), also demonstrated a minimal inhibition of CYPs 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Croatian: Nadalje, metaboliti avanafila (M4, M16 i M27), također su pokazali minimalnu inhibiciju CYP 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4.
English: If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Croatian: Ako se Spedra uzima s hranom, početak djelovanja može biti odgođen u usporedbi početkom djelovanja natašte (vidjeti dio 5.2).
English: Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP.
Croatian: Na temelju in vitro podataka, avanafil bi, u klinički značajnim koncentracijama, mogao biti inhibitor BCRP-a.
English: In both cohorts, one subject experienced a decrease in blood pressure without symptoms of hypotension, which resolved within 1 hour of onset.
Croatian: U obje skupine, jedan je ispitanik imao sniženje krvnog tlaka bez simptoma hipotenzije, što se povuklo unutar 1 sata od nastupa.
English: PHARMACEUTICAL FORM AND CONTENTS 4x1 tablets
Croatian: OBLIK I SADRŽAJ 4x1 tableta
English: • an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells
Croatian: • poremećeni nalaz pretrage krvi za bilirubin, kemijske tvari koja se stvara normalnom razgradnjom crvenih krvnih stanica
English: The European Medicines Agency has waived the obligation to submit the results of studies with Spedra in all subsets of the paediatric population in erectile dysfunction (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Spedra u svim podskupinama pedijatrijske populacije u indikaciji erektilne disfunkcije (vidjeti dio 4.2 za podatke o pedijatrijskoj primjeni).
English: The maximum concentration and exposure was similar to that observed after subjects with normal hepatic function received an efficacious avanafil 100 mg dose.
Croatian: Maksimalna koncentracija i izloženost bile su slične onima opaženim nakon što su ispitanici s normalnom funkcijom jetre primili djelotvornu dozu avanafila od 100 mg.
English: Dose adjustments are not required in elder patients.
Croatian: U starijih bolesnika nisu potrebne prilagodbe doze.
English: There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration.
Croatian: Nema informacija o sigurnosti primjene avanafila u bolesnika s poremećajima krvarenja ili aktivnom peptičkom ulceracijom.
English: Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.
Croatian: Za bolesnike koji pokažu hemodinamičku nestabilnost na terapiji samo alfa blokatorima, imaju povećan rizik od simptomatske hipotenzije uz istodobnu primjenu avanafila.
English: Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure.
Croatian: Pokazalo se da Spedra povećava učinke tih lijekova i jako snizuje krvni tlak.
English: Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine.
Croatian: Ne očekuje se da će bubrežna dijaliza ubrzati klirens jer je avanafil visoko vezan na proteine plazme i ne eliminira se mokraćom.
English: In all trials, statistically significant improvement in all primary efficacy measures were observed for all three doses of avanafil compared to placebo.
Croatian: U svim ispitivanjima opaženo je statistički značajno poboljšanje svih primarnih mjera djelotvornosti za sve tri doze avanafila u usporedbi s placebom.
English: • In those patients already taking an optimised dose of Spedra, alpha-blocker therapy should be initiated at the lowest dose.
Croatian: • U onih bolesnika koji već uzimaju optimiziranu dozu Spedre, terapiju alfa blokatorima treba započeti najnižom dozom.
English: The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known.
Croatian: Nije poznato postoji li mogućnost da avanafil interferira s transportom drugih lijekova posredovanih P-gp.
English: Effects of other substances on avanafil
Croatian: Učinci drugih lijekova na avanafil
English: In such circumstances, nitrates should still only be administered under close medical supervision with appropriate haemodynamic monitoring (see section 4.3).
Croatian: U takvim okolnostima nitrate ipak valja primijeniti, ali samo pod pomnim medicinskim nadzorom uz odgovarajuće hemodinamičko praćenje (vidjeti dio 4.3).
English: • If you have any bleeding disorder or active peptic ulceration.
Croatian: • ako imate bilo kakav poremećaj krvarenja ili aktivne čireve želuca.
English: • other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4
Croatian: • druge lijekove koji mogu smanjiti razgradnju lijeka Spedra u tijelu (”umjerene inhibitore
English: • In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg.
Croatian: • U onih bolesnika koji su stabilni na terapiji alfa blokatorima, primjenu avanafila treba započeti najnižom dozom od 50 mg.
English: This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots).
Croatian: Taj lijek se koristi za liječenje plućne arterijske hipertenzije (tj. visokog krvnog tlaka u plućima) i kronične tromboembolijske plućne hipertenzije (tj. visokog krvnog tlaka u plućima zbog krvnih ugrušaka).
English: Haemodynamic interactions with doxazosin and tamsulosin were studied in healthy subjects in a twoperiod crossover-design trial.
Croatian: Hemodinamičke interakcije s doksazosinom i tamsulozinom ispitane su u zdravih ispitanika u ukriženom ispitivanju koje je obuhvaćalo dva razdoblja.
English: A clinical study was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medicinal products (amlodipine and enalapril).
Croatian: Provedeno je kliničko ispitivanje kako bi se procijenio učinak avanafila na pojačavanje djelovanja odabranih antihipertenzivnih lijekova (amlodipina i enalaprila) na sniženje krvnog tlaka.
English: • so called “alpha-blockers” - for prostate problems or for lowering your high blood pressure
Croatian: • takozvane ”alfa blokatore“ - za probleme s prostatom ili za snižavanje povišenog krvnog tlaka
English: The potential induction of CYP1A2, CYP2B6 and CYP3A4 by avanafil evaluated in primary human hepatocytes in vitro did not reveal any potential interaction at clinically relevant concentrations.
Croatian: Potencijalna indukcija CYP1A2, CYP2B6 i CYP3A4 avanafilom, procijenjena u primarnim ljudskim hepatocitima in vitro, nije otkrila nikakvu mogućnost interakcije pri klinički značajnim koncentracijama.
English: In order for Spedra to be effective, sexual stimulation is required.
Croatian: Da bi Spedra bila djelotvorna, potrebna je seksualna stimulacija.
English: The M4 metabolite shows a phosphodiesterase selectivity profile similar to that of avanafil and an in vitro inhibitory potency for PDE5 18% of that of avanafil.
Croatian: Metabolit M4 pokazuje profil selektivnosti za fosfodiesteraze sličan onome avanafila, a in vitro pokazuje snagu inhibicije za PDE5 od 18% one za avanafil.
English: Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.
Croatian: Bolesnici s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A ili B) trebaju započeti liječenje s najnižom djelotvornom dozom, i prilagođavati dozu na temelju podnošljivosti.
English: It is important to note that Spedra only works if you are sexually stimulated.
Croatian: Važno je napomenuti da Spedra djeluje samo ako ste seksualno stimulirani.
English: Talk to your doctor or pharmacist before taking Spedra:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Spedra:
English: It may be risky for you to have sexual intercourse
Croatian: • ako imate tegobe sa srcem; za Vas bi moglo biti rizično imati spolni odnos
English: In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
Croatian: In vitro ispitivanja s ljudskim trombocitima pokazuju da inhibitori PDE5 nemaju učinak na agregaciju trombocita sami za sebe, ali u supraterapijskim dozama pojačavaju antiagregacijski učinak donora dušikova oksida natrijeva nitroprusida.
English: Avanafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 4.5), and as such potentiates the hypotensive effect of nitrates (see section 4.3).
Croatian: Avanafil ima vazodilatacijska svojstva što rezultira blagim i prolaznim sniženjima krvnog tlaka (vidjeti dio 4.5), i kao takav pojačava hipotenzivni učinak nitrata (vidjeti dio 4.3).
English: It is eliminated predominantly by hepatic metabolism (mainly CYP3A4).
Croatian: Eliminira se uglavnom metabolizmom putem jetre (uglavnom CYP3A4).
English: In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Croatian: U dugotrajnom kliničkom ispitivanju, postotak bolesnika s nuspojavama smanjio se s duljim trajanjem izloženosti.
English: Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
Croatian: Bolesnici s blagim do umjerenim oštećenjem bubrega (klirens kreatinina ≥ 30 ml/min, ali < 80 ml/min), koji su bili uključeni u ispitivanja faze 3, pokazali su smanjenu djelotvornost u usporedbi s onima s normalnom funkcijom bubrega.
English: The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain.
Croatian: Najčešće nuspojave prijavljene u kliničkim ispitivanjima bile su glavobolja, crvenilo uz osjećaj vrućine, kongestija nosa i sinusa te bol u leđima.
English: These differences were maintained with long term treatment (as per studies in the general ED population, in diabetics with EDand in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial).
Croatian: Te su se razlike održale uz dugotrajno liječenje (u ispitivanjima u općoj populaciji s ED, u bolesnika s dijabetesom i ED, u muškaraca s ED nakon bilateralne radikalne prostatektomije s očuvanjem neurovaskularnog snopa te u otvorenom produžetku ispitivanja).
English: Studies have shown that medicinal products that inhibit CYP3A4 can increase avanafil exposure (see section 4.2).
Croatian: Ispitivanja su pokazala da lijekovi koji inhibiraju CYP3A4 mogu povećati izloženost avanafilu (vidjeti dio 4.2).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane opadajućim redoslijedom prema ozbiljnosti.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza „EXP“ ili „Rok valjanosti“.
English: The safety and efficacy of combinations of avanafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied (see section 4.4).
Croatian: Sigurnost i djelotvornost kombinacija avanafila i drugih inhibitora PDE5 ili drugih liječenja erektilne disfunkcije nisu ispitane (vidjeti dio 4.4).
English: In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate.
Croatian: Osobito je važno da obavijestite liječnika i ne uzimate Spedru ako uzimate „nitratne“ lijekove za bolove u prsima (angina), kao što su amil nitrit ili gliceril trinitrat.
English: Also some other medicines can affect the way Spedra works.
Croatian: Osim toga, neki drugi lijekovi mogu utjecati na djelovanje lijeka Spedra.
English: • an abnormal blood test result for a prostate test called ‘PSA'
Croatian: • poremećen nalaz krvi za prostatu dobiven pretragom koja se zove ”PSA“
English: • feeling out of breath when you exert yourself
Croatian: • osjećaj nedostatka zraka kada se naprežete
English: Patients should be advised that concurrent use of avanafil and alcohol may increase the likelihood of hypotension, dizziness, or syncope.
Croatian: Bolesnike valja savjetovati da istodobno uzimanje avanafila i alkohola može povećati vjerojatnost hipotenzije, omaglice ili sinkope.
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension.
Croatian: Konzumacija alkohola u kombinaciji s avanafilom može povećati mogućnost simptomatske hipotenzije.
English: The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively.
Croatian: Koncentracije glavnih cirkulirajućih metabolita M4 i M16 u plazmi iznose približno 23% odnosno 29% koncentracije glavnog spoja.
English: The fourth study investigated the onset of action of avanafil at two doses (100 and 200 mg) in terms of per-subject proportion of sexual attempts resulting in satisfactory completion of sexual intercourse.
Croatian: U četvrtom se ispitivanju procjenjivao početak djelovanja avanafila u dvije doze (100 i 200 mg) s obzirom na udio pokušaja koji su rezultirali zadovoljavajućim spolnim odnosom po svakom ispitaniku.
English: You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse.
Croatian: Spedru biste trebali uzeti otprilike 15 do 30 minuta prije spolnog odnosa.
English: Spedra works by helping the blood vessels in your penis to relax.
Croatian: Spedra djeluje tako da pomaže opuštanje krvnih žila u penisu.
English: A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Croatian: Ukupno 1774 bolesnika primilo je avanafil, prema potrebi, u dozama od 50 mg (u jednom ispitivanju), 100 mg i 200 mg (obje doze u četiri ispitivanja).
English: Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5.
Croatian: Avanafil je visoko selektivan i potentan reverzibilni inhibitor fosfodiesteraze tipa 5 specifične za ciklički gvanozin monofosfat (cGMP).
English: Since the in vitro data identified potential avanafil interactions with CYPs 2C19, 2C8/9, 2D6 and 3A4, further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Croatian: Budući da su podaci in vitro pokazali mogućnost interakcija avanafila sa CYP 2C19, 2C8/9, 2D6 i 3A4, daljnja klinička ispitivanja s omeprazolom, roziglitazonom i desipraminom nisu otkrila klinički značajne interakcije sa CYP 2C19, 2C8/9 i 2D6.
English: Studies in vitro have shown that avanafil is highly selective for PDE5.
Croatian: Ispitivanja in vitro pokazala su da je avanafil visoko selektivan za PDE5.
English: If you have any further questions on the use of Spedra, ask your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja o primjeni lijeka Spedra, pitajte svoga liječnika ili ljekarnika.
English: When avanafil is taken with a high fat meal, the rate of absorption is reduced with a mean delay in Tmax of 1.25 hours and a mean reduction in Cmax of 39% (200 mg).
Croatian: Kada se avanafil uzme uz punomasni obrok, brzina apsorpcije se smanjuje s prosječnom odgodom Tmax od 1,25 sati i prosječnim smanjenjem vrijednosti Cmax od 39% (200 mg).
English: Across all of the pivotal trials of avanafil, the percentage of successful intercourse attempts was significantly higher for all doses of avanafil compared to placebo for attempts at all post-dosing time intervals examined.
Croatian: U svim ključnim ispitivanjima avanafila, postotak uspješnih pokušaja spolnih odnosa bio je značajno viši za sve doze avanafila u usporedbi s placebom, za pokušaje u svim ispitivanim vremenskim intervalima poslije uzimanja doze.
English: Use in patients using other medicinal products
Croatian: Primjena u bolesnika koji uzimaju druge lijekove
English: If any of the above apply to you talk to your doctor or pharmacist before taking Spedra.
Croatian: Ako se nešto od gore navedenog odnosi na Vas, obratite se liječniku ili ljekarniku prije nego što uzmete Spedru.
English: In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration.
Croatian: Rezultati in vitro pokazali su skromnu mogućnost da avanafil djeluje kao supstrat P-gp i inhibitor P-gp s digoksinom kao supstratom pri koncentracijama nižim od izračunate intestinalne koncentracije.
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: Bolesnici s gubitkom vida na jednom oku zbog nearterijske anteriorne ishemijske optičke neuropatije (NAION), bez obzira je li ta epizoda bila povezana s prethodnom izloženošću inhibitoru PDE5 ili nije (vidjeti dio 4.4).
English: You should take Spedra about 30 minutes before you have sexual intercourse.
Croatian: Spedru biste trebali uzeti otprilike 30 minuta prije spolnog odnosa.
English: • penile disorder
Croatian: • poremećaj penisa
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Croatian: U ispitivanoj populaciji nije bilo dokaza o povoljnom kliničkom učinku ove kombinacije.
English: After oral administration, avanafil is excreted as metabolites predominantly in the faeces (approximately 63% of administered oral dose) and to a lesser extent in the urine (approximately 21% of the administered oral dose).
Croatian: Nakon peroralne primjene, avanafil se izlučuje u obliku metabolita uglavnom u stolici (približno 63% primijenjene peroralne doze) a u manjoj mjeri u mokraći (približno 21% primijenjene peroralne doze).
English: In the rabbit study, maternal toxicity was observed at 240 mg/kg/day.
Croatian: U ispitivanju na kunićima, toksičnost u majki opažena je pri dozi od 240 mg/kg/dan.
English: • If you have a serious liver or kidney problem
Croatian: • ako imate ozbiljan problem s jetrom ili bubrezima
English: If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors') the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.
Croatian: Ako uzimate lijek kao što je eritromicin, amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir ili verapamil (‘umjereni inhibitori CYP3A4'), preporučena doza Spedre je tableta od 100 mg, s razmakom između doza od najmanje 2 dana.
English: The patient should be advised that in case of sudden visual effects, he should stop taking Spedra and consult a physician immediately (see section 4.3).
Croatian: Bolesniku treba savjetovati da u slučaju iznenadnih učinaka na vid prekine uzimanje Spedre i odmah zatraži mišljenje liječnika (vidjeti dio
English: If you are not sure, talk to your doctor or pharmacist before taking Spedra.
Croatian: Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što uzmete lijek Spedra.
English: In subjects with mild (creatinine clearance ≥ 50 - < 80 mL/min) and moderate (creatinine clearance ≥ 30 - < 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered.
Croatian: U bolesnika s blagim (klirens kreatinina ≥ 50 - < 80 ml/min) i umjerenim (klirens kreatinina ≥ 30< 50 ml/min) oštećenjem bubrega, farmakokinetike jednokratne doze avanafila od 200 mg nisu se promijenile.
English: These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors.
Croatian: Ti događaji, koji mogu biti popraćeni tinitusom i omaglicom, prijavljeni su u vremenskoj povezanosti s unosom inhibitora PDE5.
English: • weight gain
Croatian: • porast težine
English: Avanafil has not been evaluated in patients with erectile dysfunction due to spinal cord injury or other neurological disorders and in subjects with severe renal or hepatic impairment.
Croatian: Avanafil nije procjenjivan u bolesnika s erektilnom disfunkcijom zbog ozljede leđne moždine ili drugih neuroloških poremećaja te u ispitanika s teškim oštećenjem bubrega ili jetre.
English: • serious chest pain
Croatian: • ozbiljna bol u prsima
English: • The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).
Croatian: • Ostali sastojci su manitol, fumaratna kiselina, hidroksipropilceluloza, hidroksipropilceluloza nisko supstituirana, kalcijev karbonat, magnezijev stearat i željezov oksid, žuti (E172).
English: In the fourth study patients were encouraged to attempt sexual intercourse approximately 15 minutes post-dosing, to assess the onset of the erectogenic effect of avanafil, taken on an as needed basis, at 100 and 200 mg dose.
Croatian: U četvrtom ispitivanju se bolesnike poticalo da pokušaju spolni odnos oko 15 minuta nakon uzimanja doze, kako bi se procijenio početak erektogenog učinka avanafila uzetog prema potrebi, u dozi od 100 i 200 mg.
English: There was a statistically significant difference in maximum decrease from baseline in supine diastolic blood pressure with enalapril and avanafil only, which returned to baseline 4 hours after the dose of avanafil.
Croatian: Postojala je statistički značajna razlika u maksimalnom smanjenju od početnih vrijednosti u dijastoličkom krvnom tlaku u ležećem položaju na leđima samo uz enalapril i avanafil, a one su se vratile na početne vrijednosti 4 sata nakon doze avanafila.
English: • heartbeat changes seen on a heart tracing (ECG)
Croatian: • promjene srčanih otkucaja vidljive na elektrokardiogramu (EKG-u)
English: In a penile plethysmography (RigiScan) study, avanafil 200 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 20 minutes after dosing and overall response of these subjects to avanafil was statistically significant, compared to placebo, in the 20-40 minute time interval.
Croatian: U ispitivanju u kojemu se provodila pletizmografija penisa (RigiScan), avanafil u dozi od 200 mg izazvao je u nekih muškaraca erekcije koje su se smatrale dovoljnima za penetraciju (60% ukrućenosti prema RigiScanu) već 20 minuta nakon doziranja i sveukupni odgovor tih ispitanika na avanafil bio je statistički značajan u usporedbi s placebom u vremenskom intervalu od 20-40 minuta.