FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Maltese: (inkluż ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir u telithromycin) (ara sezzjonijiet 4.2, 4.4 u 4.5).
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).
Maltese: F'pazjenti li jkunu qed jirċievu kura konkomitanti b'inibituri moderati ta' CYP3A4 b'mod konkomitanti (inklużi erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, u verapamil), iddoża massima rakkomandata ta' avanafil ma għandhiex taqbeż 100 mg, b'intervall ta' mill-anqas 48 siegħa bejn id-dożi (ara sezzjoni 4.5).
English: Treatment of erectile dysfunction in adult men.
Maltese: Kura għal problema tal-erezzjoni tal-pene f'irgiel adulti.
English: 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.
Maltese: Is-selettività ta' madwar 20,000 darba aktar għal PDE5 kontra PDE3, enzima li tinstab fil-qalb u fil-vini u l-arterji, hija importanti għaliex PDE3 huwa involut fil-kontroll tal-kontrazzjonijiet tal-qalb.
English: • 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.
Maltese: • Is-sigurtà tal-użu kkombinat ta' avanafil u alpha blockers tista' tiġi affettwata minn fatturi oħra, inkluż it-tnaqqis fil-volum intravaskulari u prodotti mediċinali oħra kontra l-ipertensjoni.
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).
Maltese: L-għoti flimkien ta' inibituri ta' phosphodiesterase tat-tip 5 (PDE5 - type 5 phosphodiesterase inhibitors), inkluż avanafil, ma' stimulaturi ta' guanylate cyclase, bħal riociguat huwa kontraindikat minħabba li hemm il-possibbiltà li jwassal għal sintomi ta' pressjoni baxxa (ara sezzjoni 4.5).
English: Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence).
Maltese: Spedra huwa kura għal irġiel adulti li jbatu min problema talerezzjoni tal-pene (magħrufa wkoll bħala impotenza).
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension (see section 4.5).
Maltese: Il-konsum tal-alkoħol f'kombinazzjoni ma' avanafil jista' jżid il-potenzjal għal ipotensjoni sintomatika (ara sezzjoni 4.5).
English: Antihypertensives other than alpha-blockers
Maltese: Mediċini kontra l-ipertensjoni għajr alpha blockers
English: • If you are taking riociguat.
Maltese: • riociguat.
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Maltese: Pazjenti b'indeboliment fil-kliewi sever (tneħħija tal-krejatinina < 30 mL/min).
English: Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP.
Maltese: Ibbażat fuq dejta in vitro, f'konċentrazzjonijiet klinikament rilevanti avanafil jista 'jkun inibitur ta' BCRP.
English: 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.
Maltese: Fl-istudju dwar kemm Idum biex jaħdem, avanafil were titjib statistikament sinifikanti fil-varjabbli dwar l-effikaċja primarja (medja tal-proporzjon għal kull individwu li kellu rispons ta' suċċess mal-ħin wara li tingħata d-doża, mal-Profil tal-Laqgħa Sesswali 3 -SEP3) meta mqabbel mal-plaċebo, li wassal għal rapport sesswali ta' suċċess f'24.71% tal-attentati għad-doża ta' 100 mg u 28.18% għaddoża ta' 200 mg wara madwar 15-il minuta wara d-doża meta mqabbla ma' 13.78% għal plaċebo.
English: Other strong inhibitors of CYP3A4 (e.g. itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin) would be expected to have similar effects.
Maltese: (eż. itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, u telithromycin) huma mistennija li jkollhom effetti simili.
English: Effects of avanafil on other medicinal products
Maltese: Effetti ta' avanafil fuq prodotti mediċinali oħra
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension.
Maltese: Il-konsum tal-alkoħol f'kombinazzjoni ma' avanafil jista' jżid il-potenzjal għal ipotensjoni sintomatika.
English: CYP3A4 substrate
Maltese: Substrat ta' CYP3A4
English: Studies in vitro have shown that avanafil is highly selective for PDE5.
Maltese: Studji in vitro wrew li avanafil huwa selettiv ħafna għal PDE5.
English: 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).
Maltese: Jekk Spedra jintuża flimkienma' xi prodott mediċinali ieħor li jnaqqas il-pressjoni sistemika tad-demm, l-effetti addittivi jistgħu jwasslu għal ipotensjoni sintomatika (eż. sturdament,, sinkope jew kważi sinkope).
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).
Maltese: Meta avanafil jittieħed ma' ikla b'kontenut għoli ta' xaħam, ir-rata ta' assorbiment titnaqqas b'dewmien medju fit-Tmax ta' 1.25 siegħa u tnaqqis medju fisCmax ta' 39% (200 mg).
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets
Maltese: Spedra 50 mg pilloli
English: • penile disorder
Maltese: • disturb fil-pene
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).
Maltese: Wara l-għoti orali, avanafil jiġi eliminat bħala metaboliti b'mod predominanti fl-ippurgar (madwar 63% tad-doża orali li tingħata) u ftit anqas flawrina (madwar 21% tad-doża orali li tingħata).
English: 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.
Maltese: Meta stimulazzjoni sesswali tikkawża r-rilaxx lokali talossidu nitriku, l-inibizzjoni tal-PDE5 permezz ta' avanafil tipproduċi żieda fil-livelli ta' cGMP filcorpus cavernosum tal-pene.
English: No cases were reported during clinical trials of avanafil (see section 4.4).
Maltese: Ma kinux irrappurtati każijiet matul il-provi kliniċi b'avanafil (ara sezzjoni 4.4).
English: 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.
Maltese: F'irġiel bid-dijabete mellitus tat-Tip 1 jew tat-Tip 2, il-perċentwali medju ta' tentattivi li rriżultaw f'kopulazzjoni b'suċċess kien ta' madwar 34% u 40% għall-gruppi li ħadu avanafil 100 mg u 200 mg, rispettivament, meta mqabbla ma' madwar 21% għall-grupp li ħa l-plaċebo.
English: Each tablet contains 50 mg of avanafil.
Maltese: Kull pillola fiha 50 mg avanafil.
English: Subjects with mild hepatic impairment (Child-Pugh A) had comparable exposure to subjects with normal hepatic function when a single dose of 200 mg avanafil was administered.
Maltese: Individwi b'indeboliment fil-fwied ħafif (Child-Pugh A) kellhom espożizzjoni komparabbli għal individwi b'funzjoni epatika normali meta ngħatat doża unika ta' 200 mg ta' avanafil.
English: CYP3A4 Inhibitors
Maltese: Inibituri ta' CYP3A4
English: Cytochrome P450 Inducers
Maltese: Induzzjoni taċ-ċitokromu P450
English: Limited data are available in elder patients aged 70 years or above.
Maltese: Id-dejta disponibbli f'pazjenti aktar anzjani ta' 70 sena u aktar hija limitata.
English: 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).
Maltese: Fil-firien tqal, ma kien hemm l-ebda evidenza ta' teratoġeniċità, effett tossiku fuq l-embriju, jew effett tossiku fuq il-fetu b'dożi sa 300 mg/kg/jum (madwar 15-il darba l-MRHD fuq bażi ta' mg/m fuq individwu ta' 60 kg).
English: 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.
Maltese: Abbażi tal-kejl ta' avanafil fis-semen ta' voluntiera b'saħħithom 45-90 minuta wara l-għoti tad-doża, anqas minn 0.0002% tad-doża mogħtija tista' tidher fis-semen tal-pazjenti.
English: L-1611 Luxembourg
Maltese: Il-Lussemburgu
English: • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
Maltese: • Jekk qed tieħu mediċini għall-HIV jew l-AIDS bħal ritonavir, indinavir, saquinavir, nelfinavir jew atazanavir
English: Cytochrome P450 Induction
Maltese: Indutturi taċ-ċitokromu P450
English: Each tablet contains 100 mg of avanafil.
Maltese: Kull pillola fiha 100 mg avanafil.
English: 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.
Maltese: F'pazjenti li kienu qed jirċievu kura stabbli b'doxazosin, it-tnaqqis massimu medju mingħajr ir-riżultati tal-grupp tal-plaċebo fil-pressjoni sistolika tad-demm meta l-pazjent kien bilwieqfa u mimdud fuq dahru wara l-għoti ta' dożi ta' avanafil kienu ta' 2.5 mmHg u 6.0 mmHg, rispettivament.
English: • sinus congestion
Maltese: • konġestjoni fis-sinus
English: Studies have shown that medicinal products that inhibit CYP3A4 can increase avanafil exposure (see section 4.2).
Maltese: Studji wrew li prodotti mediċinali li jinibixxu CYP3A4 jistgħu jżidu l-espożizzjoni għal avanafil (ara sezzjoni 4.2).
English: Each tablet contains 200 mg of avanafil.
Maltese: Kull pillola fiha 200 mg avanafil.
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1161, Il-Lussemburgu
English: Penis disorder Spontaneous penile erection
Maltese: Erezzjoni spontanja tal-pene Ħakk ġenitali
English: 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.
Maltese: L-espożizzjoni 4 sigħat wara l-għoti tad-doża kienet aktar baxxa f'individwi b'indeboliment fil-fwied moderat (Child-Pugh B) meta mqabbla ma' individwi b'funzjoni epatika normali wara 200 mg ta' avanafil.
English: How to store Spedra
Maltese: X'fih Spedra
English: The maximum concentration and exposure was similar to that observed after subjects with normal hepatic function received an efficacious avanafil 100 mg dose.
Maltese: Il-konċentrazzjoni massima u l-espożizzjoni kienet simili għal dik osservata wara li individwi b'funzjoni epatika normali rċevew doża effikaċi ta' avanafil ta' 100 mg.
English: Pale yellow oval tablets, debossed with “50” on one side.
Maltese: Pilloli ovali sofor ċari, immarkati b'“50” fuq naħa waħda.
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets
Maltese: Spedra 200 mg pilloli
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.
Maltese: Riżultati in vitro għal avanafil urew potenzjal modest li jaġixxi bħala substrat ta' P-gp u inibitur ta' Pgp b'digoxin bħala substrat f'konċentrazzjonijiet aktar baxxi mill-konċentrazzjoni intestinali kkalkulata.
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.
Maltese: (eż. bosentan, carbamazepine, efavirenz, phenobarbital u rifampicin) fuq il-farmakokinetika u l-effikaċja ta' avanafil ma ġiex evalwat.
English: Pale yellow oval tablets, debossed with “200” on one side.
Maltese: Pilloli ovali sofor ċari, immarkati b'“200” fuq naħa waħda.
English: Package leaflet: Information for the patient Spedra 100 mg tablets avanafil
Maltese: Informazzjoni għall-pazjent Spedra 100 mg pilloli avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets
Maltese: Spedra 100 mg pilloli
English: Pale yellow oval tablets, debossed with “100” on one side.
Maltese: Pilloli ovali sofor ċari, immarkati b'“100” fuq naħa waħda.
English: Seasonal allergy
Maltese: Allerġija staġjonali
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 2x1, 4x1, 8x1 and 12x1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PCTFE/Aluminju b'sarbut toqob biex tinqata' doża waħda f'kartun ta' 2 pilloli x1, 4 pilloli x1, 8 pilloli x1 u 12-il pillola x1.
English: • carbamazepine - for epilepsy, to stabilise your mood or for certain types of pain
Maltese: • carbamazepine - għall-epilessija, biex tistabbilizza l-burdata tiegħek jew għal ċerti tipi ta' uġigħ
English: 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.
Maltese: Ritonavir (600 mg darbtejn kuljum), inibitur qawwi ħafna ta' CYP3A4, li jinibixxi wkoll lil CYP2C9, b'doża waħda żied is-Cmax u l-AUC ta' avanafil 50 mg , ugwali għal madwar darbtejn u 13-il darba, u tawwal il-half-life ta' avanafil għal madwar 9 sigħat.
English: Package leaflet: Information for the patient Spedra 200 mg tablets avanafil
Maltese: Informazzjoni għall-pazjent Spedra 200 mg pilloli avanafil
English: Pharmaprim AB Tlf: +46 8355933
Maltese: Tlf: +46 8355933
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/004-007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/841/004-007
English: • itching in the genital area
Maltese: • ħakk fil-parti ġenitali
English: 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).
Maltese: Ipotensjoni kienet irrapportata wara t-tqegħid fis-suq b'inibituri oħra ta' PDE5, u sturdament, sintomu ikkawżat b'mod komuni minn tnaqqis fil-pressjoni tad-demm, ġie rrapportat fi provi kliniċi b'avanafil (ara sezzjoni 4.5).
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).
Maltese: B'kollox, 7/24 individwu esperjenzaw valuri jew tnaqqis millinja bażi li kienu ta' importanza klinika potenzjali wara l-għoti ta' dożi ta' avanafil (ara sezzjoni 4.4).
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PCTFE/Aluminju b'sarbut toqob biex tinqata' doża waħda f'kartun ta' 4 pilloli x1, 8 pilloli x1 u 12-il pillola x1.
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets avanafil
Maltese: Spedra 50 mg pilloli avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets avanafil
Maltese: Spedra 200 mg pilloli avanafil
English: It is important to note that Spedra only works if you are sexually stimulated.
Maltese: Huwa importanti li tinnota li Spedra jaħdem biss jekk tkun stimulat sesswalment.
English: Hepatic impairment
Maltese: Influwenza Nasofarinġite
English: In clinical studies, riociguat has shown to augment the hypotensive effects of PDE 5 inhibitors.
Maltese: Fi studji kliniċi, riociguat wera li jkabbar l-effetti ipotensivi ta' inibituri ta' PDE5.
English: The small changes in avanafil Cmax are considered to be of minimal clinical significance.
Maltese: It-tibdil żgħir fis-Cmax ta' avanafil huwa meqjus li huwa ta' importanza klinika minima.
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.
Maltese: B'doża tossika għall-omm ta' 1000 mg/kg/jum (madwar 49 darba l-MRHD fuq bażi ta' mg/m 2), kien hemm tnaqqis fil-piż tal-fetu mingħajr ebda sinjali ta' teratoġeniċità.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/008-011
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/841/008-011
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.
Maltese: Fi prova dwar il-fertilità u l-iżvilupp embrijoniku bikri tal-firien, tnaqqis fil-fertilità u l-motilità talisperma, tibdil fiċ-ċikli estruwi, u żieda fil-perċentwali ta' sperma anormali seħħew f'1000 mg/kg/jum, doża li kkawżat ukoll tossiċità parentali fl-irġiel u n-nisa ttrattati.
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).
Maltese: Dawn id-differenzi nżammu b'kura fit-tul (skond l-istudji tal-popolazzjoni globali b'ED, f'pazjenti dijabetiċi li jbatu minn ED u f'irġiel b'ED wara prostatektomija bilaterali radikali li ssalva n-nervituri u fi prova estiża open-label.
English: • If certain serious eye problems run in your family (such as retinitis pigmentosa).
Maltese: • Jekk għandek ċerti problemi serji fl-għajnejn fil-familja tiegħek (bħal retinitis pigmentosa)
English: • muscle spasms
Maltese: • fġir mill-imnieħer
English: Avanafil was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days.
Maltese: Avanafil ma nstabx li jakkumula fil-plażma meta ngħata f'dożi ta' 200 mg darbtejn kuljum fuq 7 ijiem.
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).
Maltese: Pazjenti li għandhom telf tal-vista f'għajn waħda minħabba newropatija ottika iskemika anterjuri mhux arteritika (NAION), irrispettivament minn jekk dan l-episodju kienx marbut jew le ma' espożizzjoni preċedenti għal inibitur ta' PDE5 (ara sezzjoni 4.4).
English: There was no effect of a single dose of avanafil on amlodipine plasma levels.
Maltese: Ma kien hemm l-ebda effett ta' doża unika ta' avanafil fuq il-livelli ta' amlodipine fil-plażma.
English: 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).
Maltese: L-għoti ta' avanafil flimkien ma' inibituri qawwija ta' CYP3A4, bħal ketoconazole jew ritonavir huwa kontraindikat, ara sezzjonijiet 4.2, 4.3 u 4.5.
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.
Maltese: Fil-fniek tqal, ma kienet osservata l-ebda teratoġeniċità, effett tossiku fuq l-embriju jew effett tossiku fuq il-fetu b'dożi sa 240 mg/kg/jum (madwar 23 darba l-MRHD fuq bażi ta' mg/m 2.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Maltese: Jekk il-prijapiżmu ma jiġix ittrattat minnufih, jista jkun hemm ħsara fit-tessut tal-pene u impotenza permanenti.
English: • In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg.
Maltese: • F'dawk il-pazjenti li huma stabbli fuq terapiji b'alpha blocker, avanafil għandu jinbeda fl-aktar doża baxxa ta' 50 mg.
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets avanafil
Maltese: Spedra 100 mg pilloli avanafil
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).
Maltese: L-użu konkomitanti ta' imblokkaturi alpha u avanafil jista jwassal għal ipotensjoni sintomatika f'xi pazjenti minħabba żieda fl-effetti vażodilatorji (ara sezzjoni 4.5).
English: 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).
Maltese: Ma kienu nnotati l-ebda effetti fuq ilfertilità jew il-parametri tal-isperma f'dożi sa 300 mg/kg/jum (fil-firien irġiel b'espożizzjoni 9 darbiet aktar mill-espożizzjoni umana fuq l-AUC mhux marbut f'doża ta' 200 mg).
English: Electrocardiogram abnormal
Maltese: Elettrokardjogram ma anormali Żieda fir-rata talqalb
English: 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).
Maltese: Avanafil għandu jintuża b'kawtela f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrożi kavernożali jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jistgħu jippredisponuhom għall-prijapiżmu (bħal anemija tas-sickle cell, majeloma multipla jew lewkimja).
English: Back pain Muscle tightness
Maltese: FULJETT TA' TAGĦRIF
English: • stomach ache or heartburn
Maltese: • tħoss qalbek tħabbat f'sidrek (palpitazzjonijiet)
English: Concomitant use of CYP3A4 inhibitors
Maltese: Inibituri moderati oħra ta' CYP3A4
English: Concomitant use of alcohol
Maltese: Użu konkomitanti tal-alkoħol
English: Pruritus genital
Maltese: Disturbi psikjatriċi
English: 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).
Maltese: Konsegwentement, id-doża massima rakkomandata ta' avanafil hija ta' 100 mg, mhux iktar minn darba kull 48 siegħa għal pazjenti li jkunu qed jieħdu inibituri moderati ta' CYP3A4 b'mod konkomitanti, ara sezzjoni 4.2.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/001-003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/841/001-003
English: Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.
Maltese: Pazjenti li juru instabbiltà emodinamika fuq terapija b' alpha blocker biss huma f'riskju akbar ta' pressjoni baxxa sintomatika bl-użu konkomitanti ta' avanafil.