natgillin/translations-raw huggingface dataset:
Based on these data avanafil is not anticipated to have a significant effect on other medicinal products metabolised by these enzymes. 
Na temelju tih podataka, ne očekuje se da će avanafil imati značajan učinak na druge lijekove metabolizirane tim enzimima.
Its pharmacokinetics are dose-proportional over the recommended dose range. 
Njegova farmakokinetika proporcionalna je dozi u čitavom preporučenom doznom rasponu.
Patients should be advised to stop taking PDE5 inhibitors, including avanafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing. 
Bolesnike treba savjetovati da prekinu uzimati inhibitore PDE5, uključujući avanafil, i da odmah potraže medicinsku pomoć u slučaju iznenadnog smanjenja ili gubitka sluha.
Its effect is more potent on PDE5 than on other known phosphodiesterases (> 100-fold for PDE6; > 1,000-fold for PDE4, PDE8 and PDE10; > 5,000-fold for PDE2 and PDE7; > 10,000-fold for PDE1, PDE3, PDE9, and PDE11). 
Njegov učinak je potentniji na PDE5 nego na druge poznate fosfodiesteraze (>100 puta veći za PDE6; > 1000 puta veći za PDE4, PDE8 i PDE10; > 5000 puta veći za PDE2 i PDE7; > 10 000 puta veći za PDE1, PDE3, PDE9 i PDE11).
Antihypertensives other than alpha-blockers 
Antihipertenzivi osim alfa blokatora
Based upon measurements of avanafil in semen of healthy volunteers 45-90 minutes after dosing, less than 0.0002% of the administered dose may appear in the semen of patients. 
Na temelju mjerenja avanafila u spermi zdravih dobrovoljaca 45-90 minuta nakon doziranja, manje od 0,0002% primijenjene doze može se pojaviti u spermi bolesnika.
Adverse reactions were similar to those seen at lower doses but incidence rates and severities were increased. 
Nuspojave su bile slične onima viđenim pri nižim dozama ali su stope incidencije i težina nuspojava bile povećane.
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy [NAION]) 
• ako imate gubitak vida na jednom oku zbog nedovoljnog priljeva krvi u oko (nearterijska ishemična optička neuropatija [NAION])
Tell your doctor or pharmacist if you are taking any of the following medicines: • so called “alpha-blockers” - for prostate problems or for lowering your high blood pressure 
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova: • takozvane ”alfa blokatore“ - za probleme s prostatom ili za snižavanje povišenog krvnog tlaka
Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: 
Prekinite s uzimanjem Spedre i odmah se obratite liječniku ako opazite neku od sljedećih ozbiljnih nuspojava - može Vam biti potrebno hitno medicinsko liječenje:
The recommended dose is a 100 mg tablet, as needed. 
Preporučena doza je tableta od 100 mg, prema potrebi.
Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra. 
Sok od grejpa može povećati izloženost lijeku i treba ga izbjegavati unutar 24 sata prije nego što uzmete Spedru.
Avanafil is extensively metabolised in humans. 
Avanafil se opsežno metabolizira u čovjeka.
Concomitant use of alcohol 
Istodobno uzimanje alkohola
Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance. 
Bolesnike imaju erekcije koje traju 4 sata ili dulje (prijapizam) je potrebno upozoriti da odmah potraže medicinsku pomoć.
Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state. 
Maksimalne opažene koncentracije plazme dosegnute su unutar 0,5 do 0,75 sati od peroralnog doziranja natašte.
• raised liver enzymes 
• povišeni jetreni enzimi
Sexual stimulation is required for a response to treatment. 
Za odgovor na liječenje potrebna je seksualna stimulacija.
Patients with severe hepatic impairment (Child-Pugh C). 
Bolesnici s teškim oštećenjem jetre (Child-Pugh C).
It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. 
Pripada skupini lijekova koji se zovu inhibitori fosfodiesteraze tipa 5 (PDE5).
The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil. 
Ne preporučuje se istodobna primjena avanafila i CYP induktora jer to može smanjiti djelotvornost avanafila.
Avanafil had no effect on the pharmacokinetics of amlodipine, but amlodipine increased the maximum and total exposure of avanafil by 28% and 60%, respectively (see section 4.4). 
Avanafil nije imao učinka na farmakokinetiku amlodipina, ali je amlodipin povećao maksimalnu i ukupnu izloženost avanafila za 28% odnosno 60% (vidjeti dio 4.4).
This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. 
To rezultira opuštanjem glatkih mišića i dotokom krvi u tkivo penisa što stvara erekciju.
The small changes in avanafil Cmax are considered to be of minimal clinical significance. 
Smatra se da su male promjene u Cmax za avanafil od minimalnog kliničkog značaja.
Avanafil was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days. 
Nije nađeno da se avanafil akumulira u plazmi pri dozi od 200 mg dvaput dnevno tijekom 7 dana.
Avanafil is > 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction. 
Avanafil je > 100 puta potentniji za PDE5 nego za PDE6 koji se nalazi u mrežnici i odgovoran je za fototransdukciju.
This is because Spedra can affect the way some other medicines work. 
Tako je zbog toga što Spedra na neki način može utjecati djelovanje drugih lijekova.
What you need to know before you take Spedra 
Što morate znati prije nego počnete uzimati lijek Spedra
Tell your doctor or pharmacist if you are taking any of the following medicines: 
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:
Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. 
Prema individualnoj djelotvornosti i podnošljivosti, dozu se može povećati na najvišu dozu od 200 mg ili smanjiti na dozu na 50 mg.
• If you have a serious cardiac problem 
• ako imate ozbiljni srčani problem
Remember that Spedra will only help you to get an erection if you are sexually stimulated. 
Upamtite da će Vam Spedra pomoći u postizanju erekcije samo ako ste seksualno stimulirani.
Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above. 
Prekinite uzimati Spedru i obratite se odmah liječniku ako opazite neku od iznad navedenih ozbiljnih nuspojava.
The approximately 20,000-fold selectivity for PDE5 versus PDE3, and enzyme found in heart and blood vessels, is important because PDE3 is involved in control of cardiac contractility. 
Približno 20 000 puta veća selektivnost za PDE5 naspram PDE3, i enzim nađen u srcu i krvnim žilama, važni su jer je PDE3 uključen u kontrolu srčane kontraktilnosti.
If you take too much Spedra, you should tell your doctor straight away. 
Ako ste uzeli previše lijeka Spedra morate odmah obavijestiti liječnika.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013 
Datum prvog odobrenja: 21. lipanj 2013.
In addition, a subset of patients was enrolled into an open-label extension trial with 493 patients receiving avanafil for at least 6 months and 153 patients for at least 12 months. 
Osim toga, podskupina bolesnika bila je uključena u otvoreni produžetak ispitivanja s 493 bolesnika koji su primali avanafil barem 6 mjeseci i 153 bolesnika koji su avanafil primali barem 12 mjeseci.
Protein binding is independent of total active substance concentrations, age, renal and hepatic function. 
Vezanje proteina neovisno je o ukupnim koncentracijama djelatne tvari, dobi, funkciji bubrega i jetre.
In clinical trials, avanafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to achieve and maintain an erection sufficient for satisfactory sexual activity. 
U kliničkim ispitivanjima avanafil je procjenjivan zbog svog učinka na sposobnost muškaraca s erektilnom disfunkcijom da postignu i održe erekciju dovoljnu za zadovoljavajuću spolnu aktivnost.
Pregnancy Spedra is not indicated for use in women. 
Trudnoća Spedra nije indicirana za primjenu u žena.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients since there is a degree of cardiac risk associated with sexual activity (see section 4.3). 
Prije započinjanja bilo kakvog liječenja erektilne disfunkcije, liječnici moraju uzeti u obzir kardiovaskularni status svojih bolesnika jer je spolna aktivnost u određenoj mjeri povezana sa srčanim rizikom (vidjeti dio 4.3).
In phase III clinical trials no events of “hypotension” but occasional episodes of “dizziness” were observed (see section 4.8). 
U kliničkim ispitivanjima faze III, nisu opaženi događaji ”hipotenzije” nego su opažene povremene epizode ”omaglice” (vidjeti dio 4.8).
Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil. 
Nemojte uzeti Spedru zajedno s drugim liječenjima za erektilnu disfunkciju kao što su sildenafil, tadalafil ili vardenafil.
• premature ejaculation 
• preuranjena ejakulacija
Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. 
Pijenje alkohola u isto vrijeme kada ste uzeli Spedru može Vam povećati brzinu srčanih otkucaja i sniziti krvni tlak.
Date of the latest renewal: 
Datum posljednje obnove odobrenja:
Patients should be advised to avoid grapefruit juice within 24 hours prior to taking avanafil. 
Bolesnike valja savjetovati da izbjegavaju sok od grejpa 24 sata prije uzimanja avanafila.
As dizziness and altered vision were reported in clinical trials with avanafil, patients should be aware of how they react to Spedra before driving or using machines. 
Budući da su u kliničkim ispitivanjima avanafila prijavljene omaglica i promjene vida, bolesnici bi trebali biti svjesni kako reagiraju na Spedru prije upravljanja vozilima ili rada sa strojevima.
Avanafil is rapidly absorbed after oral administration, with a median Tmax of 30 to 45 minutes. 
Avanafil se nakon peroralne primjene brzo apsorbira, uz medijan Tmax od 30 do 45 minuta.
• pain in the lower back or side of lower chest 
• bol u donjem dijelu leđa ili jedna strana donjeg dijela prsiju
In a patient who has taken avanafil within 12 hours, where nitrate administration is deemed medically necessary in a lifethreatening situation, the likelihood of a significant and potentially dangerous drop in blood pressure is increased. 
U bolesnika koji je uzeo avanafil unutar 12 sati, a primjena nitrata se smatra medicinski neophodnom u situaciji opasnoj po život, povećava se vjerojatnost da će nastupiti značajan i potencijalno opasan pad krvnog tlaka.
Consequently, the maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours for patients taking concomitant moderate CYP3A4 inhibitors (see section 4.2). 
Posljedično tome, maksimalna preporučena doza avanafila je 100 mg, i ne smije se prijeći jednom u svakih 48 sati u bolesnika koji istodobno uzimaju umjerene inhibitore CYP3A4 (vidjeti dio 4.2).
The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1). 
Preporučena doza je 100 mg uzeta prema potrebi, otprilike 15 do 30 minuta prije spolne aktivnosti (vidjeti dio 5.1).
This is thought to result from the combined effects of nitrates and avanafil on the nitric oxide/cGMP pathway. 
Smatra se da je to rezultat kombiniranih učinaka nitrata i avanafila na metabolički put dušikova oksida/cGMP.
Spedra contains the active substance avanafil. 
Spedra sadrži djelatnu tvar avanafil.
The use of avanafil is contraindicated in: 
Primjena avanafila kontraindicirana je u:
• The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products. 
• Na sigurnost kombinirane primjene avanafila i alfa blokatora mogu utjecati druge varijable, uključujući gubitak intravaskularnog volumena i druge antihipertenzivne lijekove.
In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid. 
Čini se da u čovjeka inhibitori PDE5 ne utječu na vrijeme krvarenja sami ili u kombinaciji s acetilsalicilatnom kiselinom.
At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP. 
U klinički značajnim koncentracijama avanafil nije inhibitor OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 i BSEP.
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects). 
Sveukupni štetni događaji i nuspojave u ispitanika liječenih avanafilom bile su učestalije u ispitanika s indeksom tjelesne mase (BMI) <25 (ispitanici s normalnim BMI).
Patients were instructed to take 1 dose of study medicinal product approximately 30 minutes prior to initiation of sexual activity. 
Bolesnici su dobili upute da uzmu 1 dozu ispitivanog lijeka otprilike 30 minuta prije početka spolne aktivnosti.
Do not take Spedra if any of the above apply to you. 
Nemojte uzeti lijek Spedra ako se nešto od gore navedenog odnosi na Vas.
There are no data from the use of avanafil in pregnant women. 
Nema podataka o upotrebi avanafila u trudnica.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. 
Ako se prijapizam ne liječi odmah, može rezultirati oštećenjem tkiva penisa i trajnim gubitkom potencije.
Other treatments for erectile dysfunction 
Druga liječenja za erektilnu disfunkciju
Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected. 
Iako specifične interakcije avanafila s rivaroksabanom i apiksabanom (oba supstrati CYP3A4) nisu ispitane, ne očekuje se interakcija.
Paediatric population There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction. 
Pedijatrijska populacija Nema značajne primjene lijeka Spedra u pedijatrijskoj populaciji u indikaciji erekcijske disfunkcije.
- Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; - Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); - Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater. 
- bolesnika koji su unutar zadnjih 6 mjeseci pretrpjeli infarkt miokarda, moždani udar ili po život opasnu aritmiju; - bolesnika s hipotenzijom u mirovanju (krvni tlak < 90/50 mmHg) ili hipertenzijom (krvni tlak > 170/100 mmHg); - bolesnika s nestabilnom anginom, anginom koja nastupa za vrijeme spolnog odnosa ili s kongestivnim zatajenjem srca kategoriziranom prema udruzi New York Heart Association kao klasa 2 ili više.
If Spedra is used in combination with another medicinal product which reduces systemic blood pressure, the additive effects may result in symptomatic hypotension (e.g. dizziness, light-headedness, syncope or near-syncope). 
Ako se Spedra primjenjuje u kombinaciji s drugim lijekom koji snižava sistemski krvni tlak, dodatni učinci mogu imati rezultirati simptomatskom hipotenzijom (npr. omaglica, ošamućenost, sinkopa ili stanje blizu sinkope).
Rare (may affect up to 1 in 1,000 people) 
Rijetke (mogu se pojaviti u do 1 na 1000 osoba)
Patients were initially assigned to avanafil 100 mg and at any point during the trial, they could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual response to treatment. 
Bolesnici su na početku raspoređeni na avanafil od 100 mg a u nekom trenutku tijekom ispitivanja mogli su tražiti da im se doza avanafila povisi na 200 mg ili snizi na 50 mg, ovisno o svom individualnom odgovoru na liječenje.
When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. 
Kada seksualna stimulacija uzrokuje lokalno oslobađanje dušikova oksida, inhibicija PDE5 avanafilom stvara povišene razine cGMP u korpusu kavernozumu penisa.
There was no effect of a single dose of avanafil on amlodipine plasma levels. 
Jednokratna doza avanafila nije imala učinka na razine amlodipina u plazmi.
Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure. 
Iako specifične interakcije nisu bile ispitivane, drugi inhibitori CYP3A4, uključujući sok od grejpa, vjerojatno bi povećali izloženost avanafilu.
Alpha-blockers 
Alfa blokatori
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. 
Nadalje, metaboliti avanafila (M4, M16 i M27), također su pokazali minimalnu inhibiciju CYP 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4.
If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2). 
Ako se Spedra uzima s hranom, početak djelovanja može biti odgođen u usporedbi početkom djelovanja natašte (vidjeti dio 5.2).
Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP. 
Na temelju in vitro podataka, avanafil bi, u klinički značajnim koncentracijama, mogao biti inhibitor BCRP-a.
In both cohorts, one subject experienced a decrease in blood pressure without symptoms of hypotension, which resolved within 1 hour of onset. 
U obje skupine, jedan je ispitanik imao sniženje krvnog tlaka bez simptoma hipotenzije, što se povuklo unutar 1 sata od nastupa.
PHARMACEUTICAL FORM AND CONTENTS 4x1 tablets 
OBLIK I SADRŽAJ 4x1 tableta
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells 
• poremećeni nalaz pretrage krvi za bilirubin, kemijske tvari koja se stvara normalnom razgradnjom crvenih krvnih stanica
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). 
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).
The maximum concentration and exposure was similar to that observed after subjects with normal hepatic function received an efficacious avanafil 100 mg dose. 
Maksimalna koncentracija i izloženost bile su slične onima opaženim nakon što su ispitanici s normalnom funkcijom jetre primili djelotvornu dozu avanafila od 100 mg.
Dose adjustments are not required in elder patients. 
U starijih bolesnika nisu potrebne prilagodbe doze.
There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration. 
Nema informacija o sigurnosti primjene avanafila u bolesnika s poremećajima krvarenja ili aktivnom peptičkom ulceracijom.
Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil. 
Za bolesnike koji pokažu hemodinamičku nestabilnost na terapiji samo alfa blokatorima, imaju povećan rizik od simptomatske hipotenzije uz istodobnu primjenu avanafila.
Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. 
Pokazalo se da Spedra povećava učinke tih lijekova i jako snizuje krvni tlak.
Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine. 
Ne očekuje se da će bubrežna dijaliza ubrzati klirens jer je avanafil visoko vezan na proteine plazme i ne eliminira se mokraćom.
In all trials, statistically significant improvement in all primary efficacy measures were observed for all three doses of avanafil compared to placebo. 
U svim ispitivanjima opaženo je statistički značajno poboljšanje svih primarnih mjera djelotvornosti za sve tri doze avanafila u usporedbi s placebom.
• In those patients already taking an optimised dose of Spedra, alpha-blocker therapy should be initiated at the lowest dose. 
• U onih bolesnika koji već uzimaju optimiziranu dozu Spedre, terapiju alfa blokatorima treba započeti najnižom dozom.
The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known. 
Nije poznato postoji li mogućnost da avanafil interferira s transportom drugih lijekova posredovanih P-gp.
Effects of other substances on avanafil 
Učinci drugih lijekova na avanafil
In such circumstances, nitrates should still only be administered under close medical supervision with appropriate haemodynamic monitoring (see section 4.3). 
U takvim okolnostima nitrate ipak valja primijeniti, ali samo pod pomnim medicinskim nadzorom uz odgovarajuće hemodinamičko praćenje (vidjeti dio 4.3).
• If you have any bleeding disorder or active peptic ulceration. 
• ako imate bilo kakav poremećaj krvarenja ili aktivne čireve želuca.
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4 
• druge lijekove koji mogu smanjiti razgradnju lijeka Spedra u tijelu (”umjerene inhibitore
• In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg. 
• U onih bolesnika koji su stabilni na terapiji alfa blokatorima, primjenu avanafila treba započeti najnižom dozom od 50 mg.
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). 
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).
Haemodynamic interactions with doxazosin and tamsulosin were studied in healthy subjects in a twoperiod crossover-design trial. 
Hemodinamičke interakcije s doksazosinom i tamsulozinom ispitane su u zdravih ispitanika u ukriženom ispitivanju koje je obuhvaćalo dva razdoblja.
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). 
Provedeno je kliničko ispitivanje kako bi se procijenio učinak avanafila na pojačavanje djelovanja odabranih antihipertenzivnih lijekova (amlodipina i enalaprila) na sniženje krvnog tlaka.
• so called “alpha-blockers” - for prostate problems or for lowering your high blood pressure 
• takozvane ”alfa blokatore“ - za probleme s prostatom ili za snižavanje povišenog krvnog tlaka
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. 
Potencijalna indukcija CYP1A2, CYP2B6 i CYP3A4 avanafilom, procijenjena u primarnim ljudskim hepatocitima in vitro, nije otkrila nikakvu mogućnost interakcije pri klinički značajnim koncentracijama.
In order for Spedra to be effective, sexual stimulation is required. 
Da bi Spedra bila djelotvorna, potrebna je seksualna stimulacija.
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. 
Metabolit M4 pokazuje profil selektivnosti za fosfodiesteraze sličan onome avanafila, a in vitro pokazuje snagu inhibicije za PDE5 od 18% one za avanafil.