FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore decided that Farydak's benefits are greater than its risks in this group and recommended that it be approved for use in the EU.
Maltese: Is-CHMP għaldaqstant iddeċieda li l-benefiċċji ta' Farydak huma akbar mir-riskji tiegħu f'dan il-grupp u rrakkomanda li jiġi approvat għall-użu fl-UE.
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex France
Maltese: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex Franza
English: Do not take Spedra:
Maltese: Tiħux Spedra:
English: The M16 metabolite was inactive against PDE5.
Maltese: Il-metabolit M16 kien inattiv kontra PDE5.
English: Angina pectoris Tachycardia
Maltese: Anġina pectoris Takikardja
English: ATC code: G04BE10.
Maltese: G04BE10.
English: • The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).
Maltese: • Is-sustanzi l-oħra huma mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate u ferric oxide yellow (E172).
English: Psychomotor hyperactivity
Maltese: Iperattività psikomotorili
English: Visual problems
Maltese: Problemi fil-vista
English: • The active substance is avanafil.
Maltese: • Is-sustanza attiva hija avanafil.
English: Adverse reaction (MedDRA Preferred Term) System Organ Class Common
Maltese: Reazzjoni avversa (Terminu Ppreferut MedDRA) Klassifika tas-Sistemi u tal-Organi
English: Spedra with drink and alcohol
Maltese: Spedra ma' xorb u alkoħol
English: • phenobarbital or primidone - for epilepsy
Maltese: • phenobarbital jew primidone - għall-epilessija
English: Potential for pharmacodynamic interactions with avanafil Nitrates
Maltese: Potenzjal ta' interazzjonijiet farmakodinamiċi b'avanafil Nitrati
English: inhibitors') including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
Maltese: inklużi amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, u verapamil
English: Avanafil is approximately 99% bound to plasma proteins.
Maltese: Avanafil jeħel madwar 99% mal-proteini tal-plażma.
English: At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
Maltese: F'konċentrazzjonijiet klinikament rilevanti avanafil mhuwiex inibitur ta OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 u BSEP.
English: Spedra contains the active substance avanafil.
Maltese: Spedra fih is-sustanza attiva avanafil.
English: L-1611 Luxembourg,
Maltese: L-1161, Il-Lussemburgu
English: Patients with severe hepatic impairment (Child-Pugh C).
Maltese: Pazjenti b'indeboliment fil-fwied sever (Child-Pugh C).
English: Further, the metabolites of avanafil (M4, M16 and M27), also demonstrated a minimal inhibition of CYPs 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Maltese: Barra minn hekk, il-metaboliti ta' avanafil (M4, M16 u M27), urew ukoll inibizzjoni minima ta' CYPs 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4.
English: In the rabbit study, maternal toxicity was observed at 240 mg/kg/day.
Maltese: tossiċità materna kienet osservata b'doża ta' 240 mg/kg/jum.
English: • premature ejaculation
Maltese: • eġakulazzjoni prematura
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 Ġunju 2013
English: The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Maltese: It-tabella ta' hawn taħt telenka r-reazzjonijiet avversi osservati fi provi kliniċi kkontrollati bi plaċebo skont il-konvenzjoni tal-frekwenza MedDRA: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Therefore, M4 accounts for approximately 4% of total pharmacologic activity.
Maltese: Għalhekk, M4 jirrappreżenta madwar 4% tal-attività farmakoloġika totali.
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.
Maltese: Il-metabolit M4 juri profil ta' selettività għal phosphodiesterase simili għal dak ta' avanafil u qawwa inibitorja in vitro għal PDE5 ta' 18% dik ta' avanafil.
English: 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).
Maltese: L-effett tiegħu huwa aktar qawwi fuq PDE5 milli fuq phosphodiesterases magħrufa oħra (> 100 darba aktar għal PDE6; > 1,000 darba aktar għal PDE4, PDE8 u PDE10; > 5,000 darba aktar għal PDE2 u PDE7; > 10,000 darba aktar għal PDE1, PDE3, PDE9, u PDE11).
English: Menarini Benelux NV/SA
Maltese: Luxembourg/Luxemburg Menarini Benelux NV/SA
English: The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program.
Maltese: Il-profil tas-sigurtà ta' Spedra huwa bbażat fuq 2,566 individwu esposti għal avanafil matul il-programm ta' żvilupp kliniku.
English: • spontaneous erection without sexual stimulation
Maltese: • erezzjoni spontanja mingħajr stimulazzjoni sesswali
English: Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section 4.5).
Maltese: Pazjenti li qed jużaw xi forma ta' nitrat organiku jew donaturi ta' ossidu nitriku (bħal amyl nitrite) (ara sezzjoni 4.5).
English: 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
Maltese: EU/1/13/841/008 4 pilloli EU/1/13/841/009 8 pilloli EU/1/13/841/010 12-il pillola EU/1/13/841/011 2 pilloli
English: The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively.
Maltese: Il-konċentrazzjonijiet fil-plasma tal-metaboliti prinċipali fiċ-ċirkolazzjoni, M4 u M16, huma ta' madwar 23% u 29% dak tal-kompost prinċipali, rispettivament.
English: Other medicines and Spedra
Maltese: Mediċini oħra u Spedra
English: • If you have any bleeding disorder or active peptic ulceration.
Maltese: • Jekk għandek disturb ta' fsada jew ulċerazzjoni peptika attiva.
English: In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
Maltese: Studji in vitro bi plejtlits umani jindikaw li weħidhom l-inibituri ta' PDE5 ma għandhom l-ebda effett fuq l-aggregazzjoni tal-plejtlits, iżda f'dożi supraterapewtiċi jżidu l-effett antiaggregatorju tad-donatur tal-ossidu nitriku sodium nitroprusside.
English: • antibiotics for infections such as erythromycin
Maltese: • antibijotiċi għall-infezzjonijiet bħal erythromycin
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).
Maltese: Avanafil ma kellu l-ebda effett fuq il-farmakokinetika ta' amlodipine, imma amlodipine żied lespożizzjoni totali u massima ta' avanafil bi 28% u 60%, rispettivament (ara sezzjoni 4.4).
English: Amlodipine (5 mg daily) increased avanafil 200 mg single-dose Cmax and AUC by approximately 28% and 60%, respectively.
Maltese: Amlodipine (5 mg kuljum) żied is-Cmax u l-AUC ta' avanafil b'doża waħda ta' 200 mg b'madwar 28% u 60%, rispettivament.
English: • other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4
Maltese: • mediċini oħra li jistgħu jnaqqsu t-tkissir ta' Spedra fil-ġisem (‘inibituri moderati ta' CYP3A4')
English: • medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,
Maltese: • mediċini għal taħbit irregolari tal-qalb (“arritmija”) bħal quinidine, procainamide, amiodarone jew sotalol
English: The use of avanafil is contraindicated in:
Maltese: L-użu ta' avanafil huwa kontraindikat:
English: Avanafil has a terminal half-life of approximately 6-17 hours.
Maltese: Avanafil għandu half-life terminali ta' madwar 6-17-il siegħa.
English: 8x1 tablets
Maltese: 8 pilloli x1
English: Avanafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Maltese: Avanafil jitneħħa primarjament mill-isoenzimi mikrosomali epatiċi CYP3A4 (rotta ewlenija) u CYP2C9 (rotta minuri).
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Jagħmel parti minn grupp ta' mediċini msejħa inibituri ta' phosphodiesterase tat-tip 5 (PDE5).
English: INFORMATION IN BRAILLE Spedra 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Spedra 50 mg
English: 4x1 tablets 8x1 tablets 12x1 tablets 2x1 tablets
Maltese: 4 pilloli x1 8 pilloli x1 12-il pillola x1 2 pilloli x1
English: INFORMATION IN BRAILLE Spedra 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Spedra 200 mg
English: In phase III clinical trials no events of “hypotension” but occasional episodes of “dizziness” were observed (see section 4.8).
Maltese: III ma ġie osservat l-ebda avveniment ta' “ipotensjoni” iżda kienu osservati episodji okkażjonali ta' “sturdament” (ara sezzjoni 4.8).
English: 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
Maltese: 2 pilloli EU/1/13/841/005 4 pilloli EU/1/13/841/006 8 pilloli EU/1/13/841/007 12-il pillola
English: This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots).
Maltese: Din il-mediċina tintuża biex titratta ipertensjoni fl-arterji talpulmuni (i.e., pressjoni tad-demm għolja fil-pulmuni) u ipertensjoni tromboembolika kronika tal-pulmuni (i.e., pressjoni tad-demm għolja fil-pulmuni minħabba tagħqid tad-demm).
English: Avanafil is rapidly absorbed.
Maltese: Avanafil jiġi assorbit malajr.
English: Avanafil is a substrate of and predominantly metabolised by CYP3A4.
Maltese: Avanafil huwa substrat ta' u jiġi metabolizzat prinċipalment minn CYP3A4.
English: ElderlyOlder patients (65 years or over) had comparable exposure to that seen in younger patients (18-45 years).
Maltese: Pazjenti akbar fl-età (aktar minn 65 sena) kellhom espożizzjoni komparabbli ma' dik li dehret f'pazjenti iżgħar (18-45 sena).
English: Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see sections 4.3 and 5.2).
Maltese: Spedra huwa kontraindikat f'pazjenti b'indeboliment fil-fwied sever (Child Pugh klassi C) (ara sezzjonijiet 4.3 u 5.2).
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).
Maltese: L-avvenimenti avversi ġenerali u rreazzjonijiet avversi għall-individwi li kienu qed jirċievu kura b'avanafil kienu aktar frekwenti f'individwi b'Indiċi tal-Massa tal-Ġisem (Body Mass Index (BMI)) < 25 (individwi b'BMI normali).
English: 12x1 tablets
Maltese: 12-il pillola x1
English: Since the in vitro data identified potential avanafil interactions with CYPs 2C19, 2C8/9, 2D6 and 3A4, further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Maltese: Peress li d-dejta in vitro identifikat interazzjonijiet potenzjali ta' avanafil ma' CYPs 2C19, 2C8/9, 2D6 u 3A4, studji kliniċi ulterjuri li użaw omeprazole, rosiglitazone u desipramine ma wrew l-ebda interazzjoni klinikament rilevanti ma' CYPs 2C19, 2C8/9 u 2D6.
English: INFORMATION IN BRAILLE Spedra 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Spedra 100 mg
English: The potential induction of CYP1A2, CYP2B6 and CYP3A4 by avanafil evaluated in primary human hepatocytes in vitro did not reveal any potential interaction at clinically relevant concentrations.
Maltese: L-induzzjoni potenzjali ta' CYP1A2, CYP2B6 u CYP3A4 permezz ta' avanafil evalwata f'epatoċiti primarji tal-bniedem in vitro ma wriet l-ebda interazzjoni potenzjali f'konċentrazzjonijiet klinikament rilevanti.
English: EU/1/13/841/002 8 tablets
Maltese: EU/1/13/841/002 8 pilloli
English: 2x1 tablets 4x1 tablets 8x1 tablets 12x1 tablets
Maltese: 2 pilloli x1 4 pilloli x1 8 pilloli x1 12-il pillola x1
English: EU/1/13/841/003 12 tablets
Maltese: EU/1/13/841/003 12-il pillola
English: In in vitro studies in human liver microsomes, avanafil showed a negligible potential for drug-drug interactions with CYP1A1/2, 2A6, 2B6 and 2E1.
Maltese: Fi studji in vitro fuq mikrosomi tal-fwied tal-bniedem, avanafil wera potenzjal negliġibbli għal interazzjoni bejn il-mediċini ma' CYP1A1/2, 2A6, 2B6 u 2E1.
English: • If you have a serious cardiac problem
Maltese: • Jekk għandek problema kardijaka serja
English: Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5.
Maltese: Avanafil huwa inibitur riversibbli, selettiv ħafna u qawwi ta' phosphodiesterase tat-tip 5 speċifiku għal cyclic guanosine monophosphate (cGMP).
English: PHARMACEUTICAL FORM AND CONTENTS 4x1 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 4 pilloli x1
English: • an abnormal blood test result for a prostate test called ‘PSA'
Maltese: • riżultat anormali tat-test tad-demm għal test tal-prostata msejjaħ "PSA"
English: • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate.
Maltese: • Jekk qed tieħu mediċini “nitrati” għal uġigħ fis-sider (anġina), bħal amyl nitrite jew glyceryl trinitrate.
English: One episode of “syncope” was observed in placebo and one episode on 100 mg of avanafil in phase III clinical trials.
Maltese: III kien osservat episodju wieħed ta' “sinkope” bi plaċebo u episodju wieħed b'100 mg ta' avanafil.
English: 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.
Maltese: Fil-popolazzjoni ġenerali b'ED, il-perċentwali medju ta' tentattivi li rriżultaw f'kopulazzjoni b'suċċess kien ta' madwar 47%, 58%, u 59% għall-gruppi li ħadu avanafil 50 mg, 100 mg, u 200 mg, rispettivament, meta mqabbla ma' madwar 28% għall-plaċebo.
English: 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).
Maltese: L-għoti ta' avanafil flimkien ma' inibituri qawwija ta' CYP3A4 b'mod konkomitanti (inklużi ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir u telithromycin) huwa kontraindikat (ara sezzjonijiet 4.3, 4.4 u 4.5).
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.
Maltese: Fi studju ta' plethysmography (RigiScan) tal-pene, avanafil 200 mg ipproduċa erezzjonijiet meqjusa suffiċjenti għall-penetrazzjoni (riġidità ta' 60% permezz ta' RigiScan) f'xi rġiel minn 20 minuta wara l-għoti tad-doża u r-rispons ġenerali ta' dawn l-individwi għal avanafil kien statistikament sinifikanti, meta mqabbel ma' plaċebo, fl-intervall ta' ħin ta' 20-40 minuta.
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.
Maltese: Jekk qed tieħu mediċina bħal erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir jew verapamil (‘inibituri moderati ta' CYP3A4') id-doża rakkomandata ta' Spedra hija pillola waħda ta' 100 mg, b'intervall ta' mill-anqas jumejn bejn id-dożi.
English: Concomitant use of alpha-blockers
Maltese: Użu konkomitanti ta' alpha blockers
English: A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Maltese: Kien hemm total ta' 1774 pazjent li rċevew avanafil, li ttieħed kif meħtieġ f'dożi ta' 50 mg (studju wieħed), 100 mg, u 200 mg (erba' studji), rispettivament.
English: A clinical study was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medicinal products (amlodipine and enalapril).
Maltese: Sar studju kliniku biex jevalwa l-effett ta' avanafil fuq iż-żieda fl-effetti ta' tbaxxija tal-pressjoni taddemm ta' prodotti mediċinali magħżula kontra l-ipertensjoni (amlodipine u enalapril).
English: Concomitant use of riociguat with PDE5 inhibitors, including avanafil, is contraindicated (see section 4.3).
Maltese: L-użu flimkien ta' riociguat u inibituri ta' PDE5, inkluż avanafil, huwa kontraindikat (ara sezzjoni 4.3).
English: Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.3 and 5.2).
Maltese: Spedra huwa kontraindikat f'pazjenti b'indeboliment fil-kliewi sever (tneħħija tal-krejatinina < 30 mL/min) (ara sezzjonijiet 4.3 u 5.2).
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.
Maltese: Avanafil kien evalwat f' 4 provi paralleli ta' gruppi, b'mod każwali, double-blind, ikkontrollati bi plaċebo, li damu għaddejjin 3 xhur fil-popolazzjoni ġenerali b'ED, f'pazjenti bid-dijabete tat-Tip 1 jew tat-Tip 2 u ED, u f'pazjenti b'ED wara prostatektomija radikali fejn in-nervituri bilaterali ġew salvati.
English: • frequent urination
Maltese: • awrina frekwenti
English: Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state.
Maltese: Il-konċentrazzjonijiet massimi osservati fil-plażma jintlaħqu fi żmien 0.5 sa 0.75 siegħa wara doża orali fl-istat sajjem.
English: It is eliminated predominantly by hepatic metabolism (mainly CYP3A4).
Maltese: Jiġi eliminat prinċipalment b'metaboliżmu fil-fwied (prinċipalment CYP3A4).
English: Medicinal products reducing systemic blood pressure As a vasodilator, avanafil may reduce systemic blood pressure.
Maltese: Prodotti mediċinali li jnaqqsu l-pressjoni sistemika tad-demm Bħala vażodilatatur, avanafil jista' jnaqqas il-pressjoni sistemika tad-demm.
English: In subjects with mild (creatinine clearance ≥ 50 - < 80 mL/min) and moderate (creatinine clearance ≥ 30 - < 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered.
Maltese: F'individwi b'indeboliment fil-kliewi ħafif (tneħħija tal-krejatinina ≥ 50 - < 80 mL/min) u moderat (tneħħija tal-krejatinina ≥ 30 - < 50 mL/min), il-farmakokinetika ta' doża unika ta' avanafil ta' 200 mg ma mbidlitx.
English: However, data on subjects older than 70 years are limited.
Maltese: Madankollu, dejta dwar individwi 'l fuq minn 70 sena hija limitata.
English: Chest pain Influenza like illness Oedema peripheral
Maltese: Uġigħ fis-sider Mard bħal tal-influwenza Edema periferali
English: 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.
Maltese: F'irġiel b'ED wara prostatektomija radikali fejn in-nervituri bilaterali ġew salvati, il-perċentwali medju ta' tentattivi li rriżultaw f'kopulazzjoni b'suċċess kien ta' madwar 23% u 26% għall-gruppi li ħadu avanafil ta' 100 mg u 200 mg, rispettivament, meta mqabbla ma' madwar 9% għall-plaċebo.
English: Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected.
Maltese: Għalkemm l-interazzjonijiet speċifiċi ta' avanafil ma' rivaroxaban u apixaban (it-tnejn substrati ta' CYP3A4) ma ġewx studjati, mhux mistenni li jkun hemm interazzjoni.
English: Consequently, co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated (see sections 4.2, 4.3 and 4.4).
Maltese: Konsegwentement, l-għoti ta' avanafil flimkien ma' inibituri qawwija ta' CYP3A4 huwa kontraindikat (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: • blurred vision.
Maltese: • vista mċajpra.
English: Cardiovascular status
Maltese: Status kardjovaskulari
English: Avanafil is > 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction.
Maltese: Avanafil huwa > 100 darba aktar qawwi għal PDE5 milli għal PDE6, li jinstab fir-retina u huwa responsabbli mill-fototransduzzjoni.
English: Avanafil is extensively metabolised in humans.
Maltese: Avanafil jiġi metabolizzat b'mod estensiv fil-bniedem.
English: 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.
Maltese: Ketoconazole (400 mg kuljum), inibitur selettiv u qawwi ħafna ta' CYP3A4, b'doża waħda ta' 50 mg żied is-Cmax u l-espożizzjoni (AUC) ta' avanafil ekwivalenti għal 3 darbiet u 14-il darba rispettivament u tawwal il-half-life ta' avanafil għal madwar 9 sigħat.
English: Flank pain Myalgia Muscle spasms
Maltese: Konġestjoni fissinus Dispneja malistrapazz
English: The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known.
Maltese: Il-potenzjal ta' avanafil li jinterferixxi mat-trasport ta' prodotti mediċinali oħra medjati b'Pgp mhux magħruf.
English: - 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.
Maltese: - F'pazjenti li kellhom infart mijokardijaku, puplesija, jew arritmija ta' periklu għall-ħajja flaħħar 6 xhur; - F'pazjenti b'ipotensjoni (pressjoni baxxa) waqt il-mistrieħ (pressjoni tad-demm < 90/50 mmHg) jew b'ipertensjoni (pressjoni għolja) (pressjoni tad-demm > 170/100 mmHg); - F'pazjenti b'anġina mhuxstabbli, anġina waqt attività sesswali, jew insuffiċjenza konġestiva tal-qalb kategorizzata bħala ta' Klassi
English: 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.
Maltese: Erythromycin (500 mg darbtejn kuljum), inibitur moderat ta' CYP3A4, żied is-Cmax u l-AUC ta' avanafil b'doża waħda ta' 200 mg ugwali għal madwar darbtejn u 3 darbiet, rispettivament, u tawwal il-half-life ta' avanafil għal madwar 8 sigħat.
English: Protein binding is independent of total active substance concentrations, age, renal and hepatic function.
Maltese: It-twaħħil mal-proteini huwa indipendenti millkonċentrazzjonijiet totali tas-sustanza attiva, l-età, il-funzjoni tal-kliewi u l-fwied.