FrancophonIA/ELRC3.0 huggingface dataset:
English: The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively.
Slovenian: Koncentraciji glavnih presnovkov v plazmi, M4 oziroma M16, sta približno 23% oziroma 29% koncentracije izhodne spojine.
English: There are no data from the use of avanafil in pregnant women.
Slovenian: Podatkov o uporabi avanafila pri nosečnicah ni.
English: This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
Slovenian: (Ta se lahko pojavi pri moških z boleznimi, kot so bolezen srpastih celic, multiplim mielomom ali levkemijo);
English: 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).
Slovenian: Avanafil ni vplival na farmakokinetiko amlodipina, je pa amlodipin povečal največjo oziroma skupno izpostavljenost avanafilu za 28% oziroma 60% (glejte poglavje 4.4).
English: Protein binding is independent of total active substance concentrations, age, renal and hepatic function.
Slovenian: Vezava je neodvisna od celokupnih koncentracij zdravilne učinkovine, starosti ter delovanja ledvic in jeter.
English: • an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells
Slovenian: • nenormalni rezultati krvnih testov bilirubina, snovi, ki nastaja ob nenormalni razgradnji rdečih krvničk
English: Spedra contains the active substance avanafil.
Slovenian: Zdravilo Spedra vsebuje zdravilno učinkovino avanafil.
English: Effects of avanafil on other medicinal products
Slovenian: Učinki avanafila na druga zdravila
English: In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid.
Slovenian: Pri ljudeh naj zaviralci PDE5 niti sami niti v kombinaciji z acetilsalicilno kislino ne bi vplivali na čas krvavitev.
English: At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m basis), decreased fetal body weight occurred with no signs of teratogenicity.
Slovenian: Pri maternalno toksičnem odmerku 1.000 mg/kg/dan (približno 49-krat večjem odmerku od MRHD na podlagi mg/m2), so zabeležili manjšo telesno maso plodov brez znakov teratogenosti.
English: Concomitant use of other treatments for erectile dysfunction The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Slovenian: Sočasna uporaba drugih zdravljenj erektilne disfunkcije Varnost in učinkovitost zdravila Spedra v kombinaciji z drugimi zaviralci PDE5 ali drugimi zdravili za zdravljenje erektilne disfunkcije nista bili preučeni.
English: It is eliminated predominantly by hepatic metabolism (mainly CYP3A4).
Slovenian: Izloča se predvsem s presnovo v jetrih (večinoma s CYP3A4).
English: PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine.
Slovenian: Pokazalo se je, da PDE5 zaviralci povečajo hipotenziven učinek teh zdravil.
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.
Slovenian: V vseh ključnih preskušanjih avanafila je bil odstotek poskusov, ki so se končali z uspešnim spolnim odnosom, pri vseh odmerkih avanafila znatno višji kot pri placebu v vseh preučevanih časovnih intervalih po odmerjanju.
English: • pain or discomfort in the lower abdomen
Slovenian: • bolečina ali neugodje v spodnjem delu trebuha
English: Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra').
Slovenian: Zdravila Spedra tudi ne smete vzeti, če jemljete zdravila za zdravljenje okužbe z virusom HIV ali aidsom, kot so ritonavir, indinavir, sakvinavir, nelfinavir ali atazanavir, ali če jemljete zdravila proti glivičnim okužbam, npr. ketokonazol, itrakonazol ali vorikonazol, ali določene antibiotike proti bakterijskim okužbam, npr. klaritromicin ali telitromicin (glejte začetek poglavja 2 pod naslovom “Ne jemljite zdravila Spedra”).
English: 12x1 tablets
Slovenian: 12x1 tableta
English: 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).
Slovenian: Splošni neželeni dogodki in neželeni učinki so bili pogostejši pri posameznikih z indeksom telesne mase (ITM) < 25 (posameznikih z normalnim ITM).
English: Penis disorder Spontaneous penile erection
Slovenian: Motnje reprodukcije in dojk motnje penisa spontana erekcija penisa genitalni pruritus
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Slovenian: Bolniki s hudo okvaro ledvic (očistek kreatinina < 30 ml/min).
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.
Slovenian: V študiji s pletizmografijo penisa (RigiScan) je 200-mg odmerek avanafila pri nekaterih moških že 20 minut po odmerjanju povzročil erekcijo, ki je zadostovala za penetracijo (60-odstotna otrdelost glede na RigiScan), poleg tega pa je bil celokupni odziv moških na avanafil v 20-40-minutnem časovnem intervalu v primerjavi s placebom statistično pomemben.
English: 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.
Slovenian: Možnega vpliva induktorjev CYP, zlasti induktorjev izoencima CYP3A4 (npr. bosentana, karbamazepina, efavirenza, fenobarbitala in rifampicina) na farmakokinetiko in učinkovitost avanafila niso preučevali.
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.
Slovenian: Statistično pomembno spremembo največjega znižanja diastoličnega krvnega tlaka leže glede na izhodišče so opazili samo pri uporabi enalaprila in avanafila, vrednosti pa so se vrnile na izhodiščne 4 ure po odmerku avanafila.
English: • In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg.
Slovenian: • pri bolnikih, katerih zdravstveno stanje je pri zdravljenju z zaviralci receptorjev alfa stabilno, je zdravljenje z avanafilom treba začeti z najmanjšim odmerkom 50 mg;
English: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Slovenian: Bolniki z obstrukcijo iztočnega trakta levega prekata, na primer aortno stenozo in idiopatsko hipertrofično subaortno stenozo, so lahko občutljivi za delovanje vazodilatatorjev, tudi za zaviralce PDE5.
English: • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
Slovenian: • če jemljete zdravila proti glivičnim okužbam, npr. ketokonazol, itrakonazol ali vorikonazol, ali določene antibiotike proti bakterijskim okužbam, npr. klaritromicin ali telitromicin;
English: 8x1 tablets
Slovenian: 8x1 tableta
English: • increased blood pressure
Slovenian: • povišan krvni tlak
English: If you take too much Spedra, you should tell your doctor straight away.
Slovenian: Če ste vzeli prevelik odmerek zdravila Spedra, se nemudoma posvetujte s svojim zdravnikom.
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.
Slovenian: Če jemljete zdravila, kot so eritromicin, amprenavir, aprepitant, diltiazem, flukonazol, fosamprenavir ali verapamil (t. i. srednje močni zaviralci CYP3A4), je priporočeni odmerek zdravila Spedra ena tableta 100 mg, pri čemer mora med posameznimi odmerjanji preteči najmanj dva dni.
English: Avanafil was evaluated in 4 randomized, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration in the general population with ED, in patients with Type 1 or Type 2 diabetes and ED, and in patients with ED following bilateral nerve-sparing radical prostatectomy.
Slovenian: Avanafil so preučevali v 4 randomiziranih, dvojno slepih, s placebom nadzorovanih študijah z vzporednima skupinama, ki so trajale do 3 mesece in so vključevale splošno populacijo moških z ED, pri bolnikih s sladkorno boleznijo tipa 1 ali 2 in ED ter bolnikih z ED, ki je bila posledica radikalne prostatektomije z ohranjanjem živcev.
English: Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.
Slovenian: Pri bolnikih, ki pri zdravljenju z zaviralci receptorjev alfa kažejo znake hemodinamične nestabilnosti, obstaja večje tveganje za simptomatsko hipotenzijo pri sočasni uporabi avanafila;
English: Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see sections 4.3 and 5.2).
Slovenian: Zdravilo Spedra je kontraindicirano pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) (glejte poglavji 4.3 in 5.2).
English: Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.3 and 5.2).
Slovenian: Zdravilo Spedra je kontraindicirano pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) (glejte poglavji 4.3 in 5.2).
English: In a rat fertility and early embryonic development trial, a decrease in fertility and sperm motility, altered estrous cycles, and an increased percentage of abnormal sperm occurred at 1000 mg/kg/day, a dose which also caused parental toxicity in the treated males and females.
Slovenian: V študiji plodnosti in zgodnjega embrionalnega razvoja pri podganah so opazili zmanjšano plodnost in gibljivost semenčic, motnje estrusa in višji odstotek nenormalnih semenčic pri odmerku 1.000 mg/kg/dan, ki je pri poskusnih samcih in samicah povzročil tudi parentalno toksičnost.
English: Use in men with diabetes Dose adjustments are not required in diabetic patients.
Slovenian: Uporaba pri moških s sladkorno boleznijo Pri moških s sladkorno boleznijo odmerka ni treba prilagajati.
English: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Slovenian: Predklinične študije so pokazale aditiven učinek na znižanje sistemskega krvnega tlaka pri uporabi zaviralcev PDE5 v kombinaciji z riociguatom.
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni sečil; zdravila za zdravljenje erektilne disfunkcije.
English: It is important to note that Spedra only works if you are sexually stimulated.
Slovenian: Pomembno je opozoriti, da zdravilo Spedra učinkuje le, če ste spolno vzburjeni.
English: 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.
Slovenian: Bolniki so na začetku jemali avanafil v odmerku 100 mg, nato pa so lahko glede na svoj odziv na zdravljenje kadarkoli med preskušanjem zahtevali povečanje odmerka na 200 mg ali zmanjšanje na 50 mg.
English: Results showed a mean maximum decrease in supine blood pressure of 2/3 mmHg compared to placebo with enalapril and 1/-1 mmHg with amlodipine when avanafil was co-administered.
Slovenian: Rezultati so pokazali, da je bilo v primerjavi s placebom povprečno največje znižanje krvnega tlaka leže ob sočasni uporabi avanafila 2/3 mmHg pri enalaprilu in 1/-1 mmHg pri amlodipinu.
English: There are no data available for subjects with severe renal insufficiency or end-stage renal disease on haemodialysis.
Slovenian: Podatki o bolnikih s hudo ledvično insuficienco ali končno ledvično odpovedjo, ki so na hemodializi, niso na voljo.
English: No cases were reported during clinical trials of avanafil (see section 4.4).
Slovenian: Med kliničnimi študijami uporabe avanafila o tovrstnih primerih niso poročali (glejte poglavje 4.4).
English: The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Slovenian: Sočasna uporaba zaviralcev fosfodiesteraze tipa 5 (PDE5), z vključno avanafilom, in spodbujevalcev gvanilat-ciklaze kot je riociguat, je kontraindicirana, saj lahko potencialno vodi v epizode simptomatske hipotenzije (glejte poglavje 4.5).
English: Avanafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Slovenian: Avanafil se izloča predvsem z jetrnima mikrosomskima izoencimoma CYP3A4 (glavna pot) in CYP2C9 (manj pomembna pot).
English: • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate.
Slovenian: • če jemljete „nitrate“ proti bolečinam v prsih (angini pektoris), kot je amil-nitrit ali gliceriltrinitrat.
English: Spedra can increase the effects of these medicines and severely lower your blood pressure
Slovenian: Zdravilo Spedra lahko poveča učinke teh zdravil in močno zniža vaš krvni tlak;
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).
Slovenian: Če se ga zaužije ob zelo mastnem obroku, se stopnja absorpcije zmanjša, pri čemer je povprečna zakasnitev Tmax 1,25 ure, povprečno znižanje Cmax pa 39 % (200 mg).
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.
Slovenian: Presnovek M4 je podobno selektiven za fosfodiesterazo kot avanafil, njegova moč zaviranja PDE5 in vitro pa je bila 18% moči avanafila.
English: In clinical studies, riociguat has shown to augment the hypotensive effects of PDE5 inhibitors.
Slovenian: V kliničnih študijah se je pokazalo, da riociguat poveča hipotenziven učinek zaviralcev PDE5.
English: 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).
Slovenian: Pri bolnikih, ki sočasno prejemajo zdravljenje s srednje močnimi zaviralci CYP3A4 (vključno z eritromicinom, amprenavirjem, aprepitantom, diltiazemom, flukonazolom, fosamprenavirjem in verapamilom), največji priporočeni odmerek avanafila ne sme presegati 100 mg, pri čemer mora med posameznimi odmerjanji preteči najmanj 48 ur (glejte poglavje 4.5).
English: Patients with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of vasodilators including avanafil (see section 4.4).
Slovenian: Bolniki z obstrukcijo iztočnega trakta levega prekata (npr. aortno stenozo ali idiopatsko hipertrofično subaortno stenozo) in bolniki s hudo okvaro avtonomnega uravnavanja krvnega tlaka so lahko še posebej občutljivi za delovanje vazodilatatorjev, tudi za avanafil (glejte poglavje 4.4).
English: 4x1 tablets 8x1 tablets 12x1 tablets 2x1 tablets
Slovenian: 4x1 tableta 8x1 tableta 12x1 tableta 2x1 tableta
English: The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known.
Slovenian: Vpliv avanafila na prenos drugih zdravil, pri katerem sodeluje P-glikoprotein, ni znan.
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).
Slovenian: Bolniki, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodno izpostavljenostjo PDE5 (glejte poglavje 4.4).
English: This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.
Slovenian: To je motnja, pri kateri penis ne otrdi ali ne ostane dovolj otrdel, da bi bil primeren za spolni odnos.
English: If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Slovenian: Če zdravilo Spedra vzamete s hrano, je začetek delovanja lahko zamaknjen v primerjavi z jemanjem zdravila na tešče (glejte poglavje 5.2).
English: Concomitant use of riociguat with PDE5 inhibitors, including avanafil, is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba riociguata z zaviralci PDE5, z vključno avanafilom, je kontraindicirana (glejte poglavje 4.3).
English: Spedra works by helping the blood vessels in your penis to relax.
Slovenian: Zdravilo Spedra pomaga sprostiti krvne žile v penisu.
English: 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.
Slovenian: Ponavljajoče peoralno odmerjanje avanafila 100 mg peroralno v obdobju 26 tednov na zdravih prostovoljcih in odraslih moških z blago erektilno disfunkcijo ni bilo povezano z neugodnimi učinki na koncentracijo in število spermijev, njihovo gibljivost ali obliko.
English: How to take Spedra
Slovenian: Kako jemati zdravilo Spedra
English: 2x1 tablets 4x1 tablets 8x1 tablets 12x1 tablets
Slovenian: 2x1 tableta 4x1 tableta 8x1 tableta 12x1 tableta
English: • If you have a physical condition that affects the shape of your penis (such as angulation,
Slovenian: • če imate telesno hibo, ki vpliva na obliko vašega penisa (na primer ukrivljenost, Peyroniejeva bolezen ali kavernozna fibroza);
English: Consequently, co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated (see sections 4.2, 4.3 and 4.4).
Slovenian: Zato je sočasna uporaba avanafila z močnimi zaviralci CYP3A4 kontraindicirana (glejte poglavja 4.2, 4.3 in 4.4).
English: • feeling weak or tired all the time
Slovenian: • občutja nenehne šibkosti in utrujenosti
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Slovenian: Pred farmakološkim zdravljenjem je treba pregledati anamnezo bolnika in opraviti klinični pregled za potrditev erektilne disfunkcije in ugotovitev možnih vzrokov zanjo.
English: 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).
Slovenian: Med 2-letnim zdravljenjem miši in podgan z odmerki do 600 ali 1.000 mg/kg/dan niso opazili z zdravljenjem povezanih sprememb na testisih, prav tako pa jih niso opazili pri psih, ki so 9 mesecev prejemali avanafil pri izpostavljenosti, ki je bila 110-krat večja od izpostavljenosti človeka pri največjem priporočenem odmerku za človeka (MRHD).
English: Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure.
Slovenian: Zdravilo Spedra lahko poveča učinke teh zdravil in močno zniža vaš krvni tlak.
English: There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration.
Slovenian: Podatkov o varnosti uporabe avanafila pri bolnikih z motnjami strjevanja krvi ali aktivno razjedo želodca ni na voljo.
English: 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).
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah so pri mladičih stalno opažali zmanjšanje telesne mase pri odmerkih 300 mg/kg/dan in več (približno 15-krat večjem odmerku od MRHD na podlagi mg/m2) in kasnejše spolno dozorevanje pri odmerkih 600 mg/kg/dan (približno 29-krat večjem odmerku od MRHD na podlagi mg/m2).
English: • If you have a serious cardiac problem
Slovenian: • če imate resne težave s srcem;
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension.
Slovenian: Sočasno uživanje alkohola in avanafila lahko poveča tveganje za simptomatsko hipotenzijo.
English: The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects (see section 4.5).
Slovenian: Sočasna uporaba zaviralcev receptorjev alfa in avanafila lahko pri nekaterih bolnikih povzroči simptomatsko hipotenzijo zaradi aditivnih vazodilatatornih učinkov (glejte poglavje 4.5).
English: The concomitant use of potent CYP3A4 inhibitors (e.g. ketoconazole and ritonavir) is associated with increased plasma exposure of avanafil (see section 4.5).
Slovenian: Sočasna uporaba močnih zaviralcev CYP3A4 (npr. ketokonazola in ritonavirja) lahko povzroči večjo izpostavljenost avanafilu v plazmi (glejte poglavje 4.5).
English: One episode of “syncope” was observed in placebo and one episode on 100 mg of avanafil in phase III clinical trials.
Slovenian: V kliničnih preskušanjih III. faze so zabeležili eno epizodo „izgube zavesti“ pri jemanju placeba in eno epizodo pri jemanju 100 mg avanafila.
English: In total, 7/24 subjects experienced values or decreases from baseline that were of potential clinical significance following avanafil dosing (see section 4.4).
Slovenian: Pri skupno 7 od 24 posameznikov so po uporabi avanafila zabeležili vrednosti ali znižanja glede na izhodišče, ki bi lahko bila klinično pomembna (glejte poglavje 4.4).
English: Concomitant use of alpha-blockers
Slovenian: Sočasna uporaba zaviralcev receptorjev alfa
English: Limited data are available in elder patients aged 70 years or above.
Slovenian: Za starejše bolnike, ki so stari 70 let in več, so podatki omejeni.
English: Breast-feeding There are no data on the use of avanafil during breast-feeding.
Slovenian: Dojenje Podatkov o uporabi avanafila med dojenjem ni.
English: • fast heart beat
Slovenian: • hiter srčni utrip
English: Amlodipine (5 mg daily) increased avanafil 200 mg single-dose Cmax and AUC by approximately 28% and 60%, respectively.
Slovenian: Amlodipin (5 mg na dan) je povečal Cmax in AUC po enkratnem odmerku 200 mg avanafila za približno 28% oziroma 60%.
English: 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.
Slovenian: Pri brejih kuncih niso opazili teratogenosti, embriotoksičnosti ali fetotoksičnosti pri odmerkih do 240 mg/kg/dan (približno 23-krat večjem odmerku od MRHD na podlagi mg/m2).