natgillin/translations-raw huggingface dataset:
Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.3 and 5.2). 
Spedra je kontraindicirana u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.3 i 5.2).
Seasonal allergy 
Poremećaji imunološkog sustava sezonska alergija
Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see sections 4.3 and 5.2). 
Spedra je kontraindicirana u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) (vidjeti dijelove 4.3 i 5.2).
In a rat pre- and post-natal development study, pups exhibited persistent decreases in body weight at 300 mg/kg/day and higher (approximately 15 times the MRHD on a mg/m basis) and delayed sexual development at 600 mg/kg/day (approximately 29 times the MRHD on a mg/m basis). 
U ispitivanju prenatalnog i postnatalnog razvoja, mladunci su pokazali perzistentna smanjenja u tjelesnoj težini pri dozi od 300 mg/kg/dan i višoj (otprilike 15 puta većoj dozi od MRHD na bazi mg/m2) i odgođen spolni razvoj pri dozi od 600 mg/kg/dan (približno 29 puta većoj dozi od MRHD na bazi mg/m
4x1 tablets 8x1 tablets 12x1 tablets 2x1 tablets 
4x1 tableta 8x1 tableta 12x1 tableta 2x1 tableta
No effects on fertility or sperm parameters were noted at doses up to 300 mg/kg/day (in male rats 9 times human exposure based on unbound AUC at a dose of 200 mg). 
Nisu uočeni učinci na plodnost ili parametre sperme pri dozama do 300 mg/kg/dan (u mužjaka štakora izloženost 9 puta veća od izloženosti u ljudi na temelju vrijednosti AUC-a nevezanog avanafila u dozi od 200 mg).
Uncommon (may affect up to 1 in 100 people) 
Manje česte (mogu se pojaviti u do 1 na 100 osoba)
In clinical studies, riociguat has shown to augment the hypotensive effects of PDE5 inhibitors. 
U kliničkim se ispitivanjima pokazalo da riocigvat pojačava hipotenzivni učinak inhibitora PDE5.
Breast-feeding There are no data on the use of avanafil during breast-feeding. 
Dojenje Nema podataka o primjeni avanafila tijekom dojenja.
In pregnant rabbits, no teratogenicity, embryotoxicity or fetotoxicity was observed at doses up to 240 mg/kg/day (approximately 23 times the MRHD on a mg/m basis. 
U trudnih kunića, teratogenost, embriotoksičnost ili fetotoksičnost nisu opaženi pri dozama do 240 mg/kg/dan (približno 23 puta veća doza od MRHD na bazi mg/m 2).
Concomitant use of riociguat with PDE5 inhibitors, including avanafil, is contraindicated (see section 4.3). 
Istodobna primjena riocigvata s inhibitorima PDE5, uključujući avanafil, je kontraindicirana (vidjeti dio 4.3).
No cases were reported during clinical trials of avanafil. 
Tijekom kliničkih ispitivanja avanafila nije bilo prijavljenih slučajeva.
One episode of “syncope” was observed in placebo and one episode on 100 mg of avanafil in phase III clinical trials. 
U kliničkim ispitivanjima faze III, opažena je jedna epizoda ”sinkope” uz placebo i jedna uz avanafil u dozi od 100 mg.
There were no treatment-related testicular findings in mice or rats treated with doses up to 600 or 1000 mg/kg/day for 2 years, and no testicular findings in dogs treated with avanafil for 9 months at exposures 110 times human exposure at the Maximum Recommended Human Dose (MRHD). 
U miševa ili štakora liječenih dozama do 600 ili 1000 mg/kg/dan tijekom 2 godine nije bilo nalaza testisa povezanih s liječenjem, nije ih bilo ni u pasa liječenih avanafilom 9 mjeseci pri izloženostima 110 puta većim od ljudske izloženosti prema maksimalnoj preporučenoj dozi u ljudi (engl.
Penis disorder Spontaneous penile erection 
Poremećaji reproduktivnog sustava i dojki poremećaj penisa spontana erekcija penisa genitalni pruritus
The potential effect of CYP inducers, especially inducers of CYP3A4 (e.g. bosentan, carbamazepine, efavirenz, phenobarbital and rifampicin) on the pharmacokinetics and efficacy of avanafil has not been evaluated. 
Nije procijenjen potencijalni učinak CYP induktora, osobito induktora CYP3A4 (npr. bosentan, karbamazepin, efavirenz, fenobarbital i rifampicin) na farmakokinetiku i djelotvornost avanafila.
Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section 4.5). 
Bolesnici koji primjenjuju bilo koji oblik organskog nitrata ili lijekovi koji su donori dušikova oksida (poput amil-nitrita) (vidjeti dio 4.5).
2x1 tablets 4x1 tablets 8x1 tablets 12x1 tablets 
2x1 tableta 4x1 tableta 8x1 tableta 12x1 tableta
In patients receiving concomitant treatment with moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil should not exceed 100 mg, with an interval of at least 48 hours between doses (see section 4.5). 
U bolesnika koji se istodobno liječe umjerenim inhibitorima CYP3A4 (uključujući eritromicin, amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir i verapamil), najviša preporučena doza avanafila ne smije prelaziti 100 mg, s razmakom između doza od najmanje 48 sati (vidjeti dio 4.5).
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. 
Da bi se dijagnosticirala erektilna disfunkcija i odredili mogući podležeći uzroci, prije razmatranja farmakološkog liječenja potrebno je uzeti anamnezu i provesti tjelesni pregled.
• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function 
• poremećeni nalaz pretrage krvi za kreatinin, kemijske tvari koja se izlučuje u mokraći i koja je mjera funkcije bubrega
Consequently, co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated (see sections 4.2, 4.3 and 4.4). 
Posljedično tome, kontraindicirana je istodobna primjena avanafila s potentnim inhibitorima CYP3A4 (vidjeti dijelove 4.2, 4.3 i 4.4).
Patients with severe renal impairment (creatinine clearance < 30 mL/min). 
Bolesnici s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min).
amiodarone or sotalol 
nelfinavir ili atazanavir
Hypotension has been reported post marketing with other PDE5 inhibitors, and dizziness, a symptom commonly caused by lowered blood pressure, has been reported in clinical trials with avanafil (see section 4.5). 
Hipotenzija je prijavljena nakon stavljanja lijeka u promet uz druge inhibitore PDE5, a u kliničkim ispitivanjima avanafila prijavljena je omaglica, simptom obično uzrokovan sniženjem krvnog tlaka (vidjeti dio 4.5).
Avanafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). 
U bolesnika s anatomskom deformacijom penisa (kao što su angulacija kavernozna fibroza ili Peyronieova bolest) ili u bolesnika sa stanjima zbog kojih postoji veća mogućnost pojave prijapizma (kao što su anemija srpastih stanica, multipli mijelom ili leukemija) avanafil treba primjenjivati s oprezom.
Amlodipine (5 mg daily) increased avanafil 200 mg single-dose Cmax and AUC by approximately 28% and 60%, respectively. 
Amlodipin (5 mg dnevno) je povećao Cmax doze avanafila od 200 mg približno za 28%, a AUC-a za 60%.
There are no data available for subjects with severe renal insufficiency or end-stage renal disease on haemodialysis. 
Nema dostupnih podataka za ispitanike s teškom insuficijencijom bubrega ili bubrežnom bolešću u završnoj fazi na hemodijalizi.
Effects of avanafil on other medicinal products 
Učinci avanafila na druge lijekove
• riociguat 
• riocigvat
In the general population with ED, the mean percentage of attempts resulting in successful intercourse was approximately 47%, 58%, and 59% for the 50 mg, 100 mg, and 200 mg avanafil groups, respectively, as compared with approximately 28% for placebo. 
U općoj populaciji sa ED, srednja vrijednost postotka pokušaja koji su rezultirali uspješnim spolnim odnosom bila je približno 47%, 58% odnosno 59% za dozu 50 mg, 100 mg odnosno 200 mg u skupinama koje su primale avanafil u usporedbi s približno 28% za placebo.
• pain or discomfort in the lower abdomen 
• bol ili nelagoda u donjem dijelu trbuha
Some men taking medicines like Spedra have had problems with their sight and hearing - see “Serious side effects” in section 4 for more details. 
Neki muškarci koji uzimaju lijekove poput Spedre imali su probleme s vidom i sluhom - za više pojedinosti vidjeti „Ozbiljne nuspojave“ u dijelu 4. Nije poznato jesu li ti problemi izravno povezani sa Spedrom, drugim bolestima koje možda imate ili s kombinacijom čimbenika.
Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated. 
Stoga je primjena avanafila kontraindicirana u bolesnika koji uzimaju bilo koji oblik organskog nitrata ili donora dušikova oksida (poput amil-nitrita).
Haematuria, haematospermia and penile haemorrhage has been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors. 
Hematurija, hematospermija i hemoragija penisa prijavljene su u malom broju slučajeva nakon stavljanja lijeka u promet i u kliničkim ispitivanjima s drugim inhibitorima PDE5.
In the Time to onset study, avanafil demonstrated statistically significant improvement in the primary efficacy variable (average per subject proportion of successful responses by time after dose administration, to the Sexual Encounter Profile 3 - SEP3) as compared with placebo, resulting in successful intercourse in 24.71% of the attempts for the 100 mg dose and 28.18% for the 200 mg dose at approximately 15 minutes after dosing compared to 13.78% for placebo. 
U ispitivanju koje je procjenjivalo vrijeme do početka djelovanja, avanafil je pokazao statistički značajno poboljšanje što se tiče primarne varijable djelotvornosti (prosječni udio uspješnih odgovora po ispitaniku prema vremenu nakon primjene doze, prema upitniku Sexual Encounter Profile 3SEP3) u usporedbi s placebom, što je rezultiralo uspješnim spolnim odnosom otprilike 15 minuta nakon doziranja u 24,71% pokušaja uz dozu od 100 mg i 28,18% uz dozu od 200 mg u usporedbi s 13,78% na placebu.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking avanafil. 
Kada se uzima avanafil, postupni povišenje doze alfa blokatora može biti povezano s daljnjim snižavanjem krvnog tlaka.
Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction. 
Farmakoterapijska skupina: Lijekovi koji djeluju na mokraćni sustav, pripravci koji se primjenjuju kod erekcijske disfunkcije.
In patients receiving stable doxazosin treatment, the placebo-subtracted mean maximum decreases in standing and supine systolic blood pressure following avanafil dosing were 2.5 mmHg and 6.0 mmHg, respectively. 
U bolesnika koji su primali stabilno liječenje doksazosinom, za placebo oduzeta srednja vrijednost maksimalnih smanjenja sistoličkog krvnog tlaka u stojećem i ležećem položaju na leđima, nakon doziranja avanafila bilo je 2,5 mmHg odnosno 6,0 mmHg.
Influenza Nasopharyngitis 
Infekcije i infestacije gripa nazofaringitis
Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. 
Očekuje se da će drugi umjereni inhibitori CYP3A4 (npr. amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir i verapamil) imati slične učinke.
The concomitant use of potent CYP3A4 inhibitors (e.g. ketoconazole and ritonavir) is associated with increased plasma exposure of avanafil (see section 4.5). 
Istodobna primjena potentnih inhibitora CYP3A4 (npr. ketokonazol i ritonavir) povezana je s povećanom izloženošću avanafilu u plazmi (vidjeti dio 4.5).
The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology. 
Ponavljana primjena avanafila od 100 mg kroz usta kod zdravih dobrovoljaca i odraslih muškaraca s blagom erektilnom disfunkcijom tijekom 26 tjedana nije bila povezana s neželjenim učincima na koncentraciju, broj, pokretljivost ili morfologiju spermija.
• feeling sleepy or very tired 
• osjećaj pospanosti ili velikog umora
In a clinical trial performed in healthy volunteers and adult males with mild erectile dysfunction, the daily administration of avanafil 100 mg oral doses over a period of 26 weeks was not associated with any untoward effects on sperm concentration, count, motility, or morphology . 
U kliničkom ispitivanju na zdravim dobrovoljcima i odraslim muškarcima s blagom erektilnom disfunkcijom, dnevna primjena peroralne doze avanafila od 100 mg u periodu od 26 tjedana nije bila povezana s neželjenim učincima na koncentraciju, broj, pokretljivost ili morfologiju spermija.
In pregnant rats, no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed at doses up to 300 mg/kg/day (approximately 15 times the MRHD on a mg/m basis in a 60 kg subject). 
U trudnih štakorica, nisu opaženi dokazi za teratogenost, embriotoksičnost ili fetotoksičnost pri dozama do 300 mg/kg/dan (približno 15 puta veća doza od MRHD na bazi mg/m u ispitanika od 60 kg).
EU/1/13/841/008 4 tablets EU/1/13/841/009 8 tablets EU/1/13/841/010 12 tablets EU/1/13/841/011 2 tablets 
EU/1/13/841/008 4 tablete EU/1/13/841/009 8 tableta EU/1/13/841/010 12 tableta EU/1/13/841/011 2 tablete
EU/1/13/841/004 2 tablets EU/1/13/841/005 4 tablets EU/1/13/841/006 8 tablets EU/1/13/841/007 12 tablets 
EU/1/13/841/004 2 tablete EU/1/13/841/005 4 tablete EU/1/13/841/006 8 tableta EU/1/13/841/007 12 tableta
• If you have a physical condition that affects the shape of your penis (such as angulation, 
• ako imate tjelesno stanje koje utječe na oblik penisa (kao što su angulacija, Peyroniejeva bolest ili kavernozna fibroza)
Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors. 
Prijapizam je prijavljen u malom broju slučajeva nakon stavljanja lijeka u promet i u kliničkim ispitivanjima s drugim inhibitorima PDE5.
• swelling in the feet or ankles 
• oticanje stopala ili gležnjeva
EU/1/13/841/003 12 tablets 
EU/1/13/841/003 12 tableta
CYP3A4 substrate 
Supstrati CYP3A4
Medicinal products reducing systemic blood pressure As a vasodilator, avanafil may reduce systemic blood pressure. 
Kao vazolidatator, avanafil može sniziti sistemski krvni tlak.
• fast heart beat 
• ubrzani srčani otkucaji
EU/1/13/841/002 8 tablets 
EU/1/13/841/002 8 tableta
In men with either Type 1 or Type 2 diabetes mellitus, the mean percentage of attempts resulting in successful intercourse was approximately 34% and 40% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 21% for the placebo group. 
U muškaraca s dijabetes melitusom tipa 1 ili tipa 2, srednja vrijednost postotka pokušaja koja je rezultirala uspješnim spolnim odnosom bila je približno 34% odnosno 40% za skupinu koja je primala 100 mg odnosno 200 mg avanafila, u usporedbi s približno 21% za placebo skupinu.
inhibitors') including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil. 
CYP3A4“) uključujući amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir i verapamil
Ketoconazole (400 mg daily), a selective and highly potent inhibitor of CYP3A4, increased avanafil 50 mg single-dose Cmax and exposure (AUC) equal to 3-fold and 14-fold respectively and prolonged the half-life of avanafil to approximately 9 hours. 
Ketokonazol (400 mg dnevno), selektivni i visoko potentni inhibitor CYP3A4, povećao je Cmax jednokratne doze avanafila od 50 mg i izloženost (AUC) jednaku 3 puta odnosno 14 puta i produljio poluvijek avanafila na približno 9 sati.
Ritonavir (600 mg twice daily), a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9, increased avanafil 50 mg single-dose Cmax and AUC equal to approximately 2-fold and 13-fold, and prolonged the half-life of avanafil to approximately 9 hours. 
Ritonavir (600 mg dvaput dnevno), visoko potentni inhibitor CYP3A4 koji također inhibira CYP2C9, povećao je Cmax i AUC jednokratne doze avanafila od 50 mg približno 2 puta odnosno 13 puta i produljio poluvijek avanafila na približno 9 sati.
How to store Spedra 
Kako čuvati lijek Spedra
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, 
• lijekove za nepravilni srčani ritam („aritmija“) kao što su kinidin, prokainamid, amiodaron ili sotalol
Co-administration of avanafil with potent inhibitors of CYP3A4, such as ketoconazole or ritonavir is contraindicated (see sections 4.2, 4.3 and 4.5). 
Kontraindicirana je istodobna primjena avanafila s potentnim inhibitorima CYP3A4, kao što su ketokonazol ili ritonavir (vidjeti dijelove 4.2, 4.3 i 4.5).
INFORMATION IN BRAILLE Spedra 200 mg 
16. PODACI NA BRAILLEOVOM PISMU Spedra 200 mg
• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir 
• ako uzimate lijekove protiv HIV-a ili AIDS-a kao što su ritonavir, indinavir, sakinavir, nelfinavir ili atazanavir
In men with ED following bilateral nerve-sparing radical prostatectomy, the mean percentage of attempts resulting in successful intercourse was approximately 23% and 26% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 9% for placebo. 
U muškaraca sa ED nakon bilateralne radikalne prostatektomije s očuvanjem neurovaskularnog snopa, srednja vrijednost postotka pokušaja koja je rezultirala uspješnim spolnim odnosom bila je približno 23% odnosno 26% za skupinu koja je primala 100 mg odnosno 200 mg avanafila, u usporedbi s približno 9% za placebo skupinu.
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg 
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L1611 Luxembourg, Luksemburg
INFORMATION IN BRAILLE Spedra 50 mg 
16. PODACI NA BRAILLEOVOM PISMU Spedra 50 mg
PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. 
Pokazalo se da inhibitori PDE5 pojačavaju učinak tog lijeka na sniženje krvnog tlaka.
The exposure 4 hours post-dose was lower in subjects with moderate hepatic impairment (Child-Pugh B) compared to subject with normal hepatic function after 200 mg of avanafil. 
Nakon avanafila u dozi od 200 mg izloženost 4 sata poslije doze bila je niža u ispitanika s umjerenim oštećenjem jetre (Child-Pugh B) u usporedbi s ispitanikom s normalnom funkcijom jetre.
There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers. 
U zdravih dobrovoljaca nije bilo učinka na pokretljivost ili strukturu sperme nakon jednokratne doze avanafila od 200 mg uzete kroz usta.
INFORMATION IN BRAILLE Spedra 100 mg 
16. PODACI NA BRAILLEOVOM PISMU Spedra 100 mg
Premature ejaculation Inappropriate affect 
Psihijatrijski poremećaji nesanica preuranjena ejakulacija neprikladni afekt
How to take Spedra 
Kako uzimati lijek Spedra
Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased 
Pretrage povišen jetreni enzim poremećaj u elektrokardiogramu povećana brzina srčanih otkucaja povišen krvni tlak prisutna krv u urinu šum na srcu povišen antigen specifičan za prostatu povećana tjelesna težina povišen bilirubin u krvi povišen kreatinin u krvi povišena tjelesna temperatura
Cytochrome P450 Inhibition 
Inhibicija citokroma P450
Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see sections 4.2, 4.4 and 4.5). 
Bolesnici liječeni potentnim inhibitorima CYP3A4 (uključujući ketokonazol, ritonavir, atazanavir, klaritromicin, indinavir, itrakonazol, nefazodon, nelfinavir, sakvinavir i telitromicin) (vidjeti dijelove 4.2, 4.4 i 4.5).
Description of selected adverse reactions observed with other PDE5 inhibitors Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors. 
Nearterijska anteriorna ishemijska optička neuropatija (NAION) i iznenadni gubitak sluha prijavljeni su u malom broju slučajeva nakon stavljanja lijeka u promet i u kliničkim ispitivanjima s drugim inhibitorima PDE5.
Chest pain Influenza like illness Oedema peripheral 
Opći poremećaji i reakcije na mjestu primjene umor astenija bol u prsima bolest nalik gripi periferni edem
• itching in the genital area 
• svrbež u području spolovila
• feeling weak or tired all the time 
• stalno prisutan osjećaj slabosti ili umora
Erythromycin (500 mg twice daily), a moderate CYP3A4 inhibitor, increased avanafil 200 mg singledose Cmax and AUC equal to approximately 2-fold and 3-fold, respectively, and prolonged the half-life of avanafil to approximately 8 hours. 
Eritromicin (500 mg dvaput dnevno), umjereni inhibitor CYP3A4, povećao je Cmax i AUC jednokratne doze avanafila od 200 mg približno 2 puta odnosno 3 puta i produljio poluvijek avanafila na približno 8 sati.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg 
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra. 
U bolesnika s već postojećom kardiovaskularnom bolešću, prije propisivanja Spedre liječnici trebaju uzeti u obzir mogući rizik koji spolna aktivnost predstavlja za srce.
• dry mouth 
• začepljen nos
Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see sections 4.3, 4.4 and 4.5). 
Kontraindicirana je istodobna primjena avanafila s potentnim inhibitora CYP3A4 (uključujući ketokonazol, ritonavir, atazanavir, klaritromicin, indinavir, itrakonazol, nefazodon, nelfinavir, sakvinavir i telitromicin) (vidjeti dijelove 4.3, 4.4 i 4.5).
• Patients should be stable on alpha-blocker therapy prior to initiating Spedra. 
• Prije nego što započnu uzimati Spedru, bolesnici moraju biti stabilni na terapiji alfa blokatorima.
No cases were reported during clinical trials of avanafil (see section 4.4). 
Tijekom kliničkih ispitivanja avanafila nije bilo prijavljenih slučajeva (vidjeti dio
There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers. 
Nakon jednokratnih peroralnih doza avanafila od 200 mg nije bilo učinka na pokretljivost ili morfologiju spermija u zdravih dobrovoljaca.
Each tablet contains 50 mg of avanafil. 
Svaka tableta sadrži 50 mg avanafila.
PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets. 
PVC/PCTFE/aluminijski perforirani blisteri s jediničnim dozama u kutijama od 4x1, 8x1 i 12x1 tableta.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of avanafil. 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 50 mg avanafila.
PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 2x1, 4x1, 8x1 and 12x1 tablets. 
PVC/PCTFE/aluminijski perforirani blisteri s jediničnim dozama u kutijama od 2x1, 4x1, 8x1 i 12x1 tableta.
Each tablet contains 200 mg of avanafil. 
Svaka tableta sadrži 200 mg avanafila.
Other strong inhibitors of CYP3A4 (e.g. itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin) would be expected to have similar effects. 
Slični učinci očekuju se i za druge snažne inhibitore CYP3A4 (npr. itrakonazol, vorikonazol, klaritromicin, nefazodon, sakvinavir, nelfinavir, indinavir, atazanavir i telitromicin).