FrancophonIA/ELRC3.0 huggingface dataset:
English: Central nervous system haemorrhages and cerebrovascular accidents (CVA) have been monitored in the last PSURs.
Maltese: Emorraġiji fis-sistema nervuża ċentrali u aċċidenti ċerebrovaskulari (CVA, cerebrovascular accidents) ġew immonitorjati fl-aħħar PSURs.
English: - Ritonavir or indinavir, medicines for HIV.
Maltese: - Ritonavir jew indinavir, mediċini għall-HIV.
English: Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Maltese: Vardenafil huwa inibitur qawwi u selettiv ta' phosphodiesetrase tip 5 (PDE5) li hu speċifiku għal cGMP u li hu l-aktar PDE komuni fil-korpus kavernożum uman.
English: In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
Maltese: Studji in vitro urew li vardenafil għandu effett aktar qawwi fuq PDE5 milli fuq phosphodiesterases oħrajn (>15-il darba meta mqabbel ma' PDE6, >130 darba meta mqabbel ma' PDE1, >300 darba meta mqabbel ma' PDE11, u >1000 darba meta mqabbel ma' PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 u PDE10).
English: The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose.
Maltese: Ir-riżultati ta' vardenafil urew żjieda f'QTc (Fridericia) ta' 8 msec (90% CI: 6-9) u ta' 10 msec (90% CI: 8-11) b'dożi ta' 10 mg u 80 mg meta mqabbla mal-plaċebo u żjieda fil-QTci ta' 4 msec (90% CI: 3-6) u ta' 6 msec (90% CI: 4-7) b'dożi ta' 10 mg u 80 mg meta mqabbla mal-plaċebo, wara siegħa li ngħatat id-doża.
English: Syncope Seizure
Maltese: Sinkope Aċċessjoni
English: The level of cGMP is regulated by the rate of synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing phosphodiesterases (PDEs).
Maltese: Il-livell ta' cGMP huwa regolat mir-rata ta' sintesi permezz ta' guanylate cyclase kif ukoll mir-rata ta' degradazzjoni permezz ta' cGMP hydrolysing phosphodiesterases (PDEs).
English: 1 x 1 orodispersible tablet 2 x 1 orodispersible tablets 4 x 1 orodispersible tablets 8 x 1 orodispersible tablets
Maltese: 1 x 1 pillola li tinħall fil-ħalq 2 x 1 pilloli li jinħallu fil-ħalq 4 x 1 pilloli li jinħallu fil-ħalq 8 x 1 pilloli li jinħallu fil-ħalq
English: Dyspepsia Gastro-oesopha geal reflux disease
Maltese: Marda ta' rifluss gastro-esofagali Gastrite
English: The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidaemia (22%), depression (5%), radical prostatectomy (9%).
Maltese: Il-gruppi ta' pazjenti li ġejjin kienu rappreżentati: anzjani (22%), pazjenti bi pressjoni għolja (35%), pazjenti li għandhom dijabete mellitus (29%), mard iskemiku tal-qalb u mard kardjovaskulari ieħor (7%), mard kroniku tal-pulmun (5%), iperlipidimja (22%), depressjoni (5%), tneħħija radikali talprostata (9%).
English: (HIV) infections.
Maltese: Infezzjonijiet u infestazzjonijiet
English: - Ketoconazole or itraconazole, anti-fungal medicines.
Maltese: - Ketoconazole jew itraconazole, mediċini kontra l-moffa.
English: Increase in gamma-glutamyl transferase
Maltese: Żjieda f'gammaglutamyltransferase
English: Concomitant use of riociguat with PDE5 inhibitors, including vardenafil, is contraindicated (see section 4.3).
Maltese: L-użu ta' riociguat flimkien ma' inibituri ta' PDE5, inkluż vardenafil, huwa kontraindikat (ara sezzjoni 4.3).
English: With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
Maltese: Bi stimulazzjoni sesswali jista' jkollok erezzjoni minn 25 minuta sa 4 jew 5 sigħat wara li tieħu l-pillola Levitra.
English: Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack and cerebral haemorrhage), have been reported in temporal association with vardenafil.
Maltese: Avvenimenti kardjovaskulari serji li jinkludu mewt għal għarrieda, takikardija, infart mijokardijaku, taki-arritmija ventrikulari, anġina pektoris, u disturbi ċerebrovaskulari (inkluż attakk iskemiku temporanju u emorraġija ċerebrali), kienu rrappurtati f'assoċjazzjoni temporali ma' vardenafil.
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku
English: The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean maximum blood alcohol level of 73 mg/dl) or single doses of antacid (magnesium hydroxide/aluminium hydroxide).
Maltese: ranitidine (150 mg darbtejn kuljum), digoxin, warfarin, glibenclamide, alkoħol (medja tal-livell massimu ta' alkoħol fid-demm ta' 73 mg/dl), jew doża waħda ta' antaċidi (magnesium hydroxide/aluminium hydroxide).
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Bayer SA-NV Tél/Tel:
English: It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum.
Maltese: Dan jattiva l-enzima guanylate cyclase u jirriżulta f'żjieda fil-livell ta' cyclic guanosine monophosphate (cGMP) fil-korpus kavernożum.
English: A single dose, double blind, crossover, randomised trial in 59 healthy males compared the effects on the QT interval of vardenafil (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo.
Maltese: Fi prova randomised, double-blind, crossover, b'doża waħda f'59 raġel b'saħħtu, ġie mqabbel l-effett ta' vardenafil (10 mg u 80 mg), sildenafil (50 mg u 400 mg) u plaċebo fuq l-intervall QT. Ġie inkluż moxifloxacin (400 mg) bħala kontroll attiv intern.
English: Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and below.
Maltese: L-AUC u Cmax ta' vardenafil f'pazjenti anzjani (65 sena jew aktar) li jieħdu vardenafil pilloli li jinħallu fil-ħalq żdiedu b'31 sa 39% u b'16 sa 21%, rispettivament, meta mqabbla ma' pazjenti b'età ta' 45 sena u anqas.
English: Reproductive system and breast disorders
Maltese: Disturbi fissistema riproduttiva u fis sider
English: Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT prolongation, concomitant administration of antiarrhythmic medicinal products in Class 1A (e.g. quinidine, procainamide), or Class III (e.g. amiodarone, sotalol).
Maltese: Prodotti mediċinali li jistgħu jtawwlu linterval QTc, inkluż vardenafil, aħjar jiġu evitati f'pazjenti b'fatturi ta' riskju relevanti, per eżempju, ipokalimja, żjieda konġenitali tal-QT, l-għoti flimkien ta' prodotti mediċinali kontra l-arritmija fi Klassi 1A (eż. quinidine, procainamide), jew fi Klassi
English: Levitra 5 mg film-coated tablets Levitra10 mg film-coated tablets Levitra 20 mg film-coated tablets
Maltese: Levitra 5 mg pilloli miksija b'rita Levitra 10 mg pilloli miksija b'rita Levitra 20 mg pilloli miksija b'rita
English: The maximum recommended dose is 20 mg.
Maltese: Id-doża massima rrakkomandata hija ta' 20 mg.
English: The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.
Maltese: Ilħila li tinżamm erezzjoni (SEP3) f'din il-popolazzjoni vasta b'ED kienet ta' 53% (5 mg), 63% (10 mg) u 65% (20 mg) meta mqabbla ma' 29% li kienu fuq plaċebo.
English: The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets ranged between 4 - 6 hours.
Maltese: Il-half-life terminali medja ta' vardenafil f'pazjenti li rċevew Levitra 10 mg pilloli li jinħallu fil-ħalq varjat minn 4-6 sigħat.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara “EXP”.
English: Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy:
Maltese: Ibbażat fuq riżultati ta' studji ta' interazzjoni li saru b'vardenafil f'pazjenti b'iperplażja beninna talprostata (BPH) li huma stabbli fuq kura ta' tamsulosin, terazosin jew alfuzosin:
English: The pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child-Pugh C) has not been studied (see section 4.3).
Maltese: Il-farmakokinetika ta' vardenafil ma ġietx studjata f'pazjenti b'indeboliment sever fil-funzjoni tal-fwied (Child-Pugh C) (ara sezzjoni 4.3).
English: Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Maltese: Minħabba l-komponent ta' nitrate għandu l-potenzjal ta' effetti ta' interazzjoni serji ma' vardenafil.
English: In the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% (patients with history of dyslipidemia) and 60% (patients with history of hypertension) of all reported attempts with vardenafil 10 mg orodispersible tablets were successful in terms of maintenance of erection.
Maltese: Fis-subgruppi definiti minn qabel 57% (pazjenti anzjani), 56% (pazjenti b'passat ta' dijabete mellitus), 59% (pazjenti b'passat ta' dislipidemija) u 60% (pazjenti b'passat ta' pressjoni għolja) ta' kull tentattiv irrappurtat b'vardenafil 10 mg pilloli li jinħallu fil-ħalq kellhom suċċess f'termini ta' żamma ta' erezzjoni.
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Bayer SA-NV
English: Concomitant use of CYP3A4 inhibitors
Maltese: L-użu flimkien ta' inibituri ta' CYP3A4
English: In volunteers with mild to moderate renal impairment (creatinine clearance 30 - 80 ml/min), the pharmacokinetics of vardenafil were similar to that of a normal renal function control group.
Maltese: F'voluntiera b'indeboliment renali ħafif għal moderat (tneħħija tal-krejatinina 30 - 80 ml/min), ilfarmakokinetika ta' vardenafil kienet simili għal dik tal-grupp ta' kontroll b'funzjoni renali normali.
English: Gastrointestinal and abdominal pain
Maltese: Uġigħ gastro intestinali u addominali
English: Levitra is not indicated for individuals below 18 years of age.
Maltese: Levitra mhux indikati għall-persuni b'età inqas minn 18-il sena.
English: And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone.
Maltese: U doża waħda mill-ħalq ta' 10 mg vardenafil mogħtija flimkien ma' 400 mg gatifloxacin, sustanza attiva b'effett QT komparabbli, uriet effett QTc addizzjonali ta' 4 msec meta mqabbel mal-effett ta' kull waħda minn dawn is-sustanzi attivi individwalment.
English: SIA Bayer Tel: +371 67 845 563
Maltese: Tel: +371 67 845 563
English: Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil (see section 4.8).
Maltese: Analiżi ta' data ta' osservazzjoni tissuġġerixxi riskju akbar ta' NAION akuta f'irġiel b'disfunzjoni erettili wara esponiment għal inibituri ta' PDE5 bħal vardenafil, tadalafil u sildenafil (ara sezzjoni 4.8).
English: Sorbitol This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.
Maltese: Sorbitol Din il-mediċina fiha 7.96 mg sorbitol f'kull pillola li tinħall fil-ħalq ta' 10 mg.
English: In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
Maltese: Studji in-vitro bi plejtlits umani jindikaw li vardenafil waħdu ma jwaqqafx l-aggregazzjoni tagħhom, iżda livelli għoljin ta' vardenafil (livell ogħla mid-doża terapewtika) iqawwu l-effett kontra laggregazzjoni ta' sodium nitroprusside, li huwa donatur ta' nitric oxide.
English: Other medicines and Levitra
Maltese: Mediċini oħra u Levitra
English: The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets.
Maltese: Il-ħin medjan biex tintlaħaq Cmax varja minn 45 sa 90 minuta u kien simili għal jew ftit aktar tard (bi 8 sa 45 minuta) meta mqabbel mal-pilloli miksija b'rita.
English: The recommended dose is 10 mg.
Maltese: Id-doża rakkomandata hija 10 mg.
English: Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, with some contribution from CYP3A5 and CYP2C isoforms.
Maltese: Vardenafil fil-biċċa l-kbira huwa mmetabolizzat mill-enzimi tal-fwied li jużaw ċitokromju P450 (CYP) isoform 3A4, bi ftit kontribuzzjoni mill-isoformi CYP3A5 u CYP2C.
English: Bayer d. o. o. Tel: +386 (0)1 58 14 400
Maltese: Tel: +386 (0)1 58 14 400
English: Increase in transaminases
Maltese: Żjieda fit transaminases
English: Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%.
Maltese: Il-metabolit (M1) għandu profil ta' selettività għal phosphodiesetrase li jixbaħ ħafna dak ta' vardenafil u qawwa in vitro għal phosphodiesetrase tip 5 ta' madwar 28% meta mqabbel ma' vardenafil, li jissarraf f'madwar 7% talkontribut għall-effikaċja'.
English: Cimetidine (400 mg twice daily), a non-specific cytochrome P450 inhibitor, had no effect on vardenafil AUC and Cmax when co-administered with vardenafil (20 mg) to healthy volunteers.
Maltese: Cimetidine (400 mg darbtejn kuljum), inibitur mhux speċifiku ta' ċitokromju P450, ma kellu l-ebda effett fuq l-AUC u s-Cmax ta' vardenafil, meta ingħata flimkien ma' vardenafil (20 mg) lill-voluntiera b'saħħithom.
English: The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
Maltese: L-interazzjoni hija konsegwenza ta' l-impediment tal-metaboliżmu ta' vardenafil fil-fwied minn ritanovir, impeditur ta' CYP3A4 qawwi ħafna, li jimpedixxi wkoll CYP2C9.
English: Vardenafil in film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms.
Maltese: Vardenafil f' pilloli miksija b'rita huwa metabolizzat fil-parti l-kbira ġol-fwied permezz ta' l-isoforma 3A4 taċ-ċitokromju P450 (CYP) b'xi kontribuzzjoni mill-isoformi CYP3A5 u CYP2C.
English: Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
Maltese: Ġie muri li doża waħda mill-ħalq ta' 10 mg u 80 mg vardenafil itawwlu l-interval QTc b'medja ta' 8 msec u 10 msec, rispettivament.
English: - Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
Maltese: Alfa-blockers, tip ta' mediċina li tintuża biex tikkura pressjoni għolja jew tkabbir tal-prostata (bħal iperplasija beninna tal-prostata).
English: Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole (oral use) should be avoided (see sections 4.3 and 4.4).
Maltese: L-użu ta' vardenafil flimkien ma' inibituri qawwija ta' CYP3A4 bħal itraconazole u ketoconazole (għall-użu orali) għandu jiġi evitat (ara sezzjoni 4.3 u 4.4).
English: Both vardenafil and sildenafil showed an increase of Fridericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone.
Maltese: Kemm vardenafil kif ukoll sildenafil urew żieda fl-effett Fredericia QTc ta' 4 msec (vardenafil) u 5 msec (sildenafil) meta mqabbla ma' kull waħda mill-mediċini mogħtija waħidha.
English: The distribution of patients in the predefined subgroups was covering elderly patients (51%), patients with history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%).
Maltese: Id-distribuzzjoni tal-pazjenti fis-sottogruppi definiti minn qabel kienet tkopri pazjenti anzjani (51%), pazjenti b'passat ta' dijabete mellitus (29%), dislipidemija (39%) u pressjoni għolja (40%).
English: Myocardial infarction Ventricular tachy-arrhythmias Angina pectoris
Maltese: Infart mijokardijaku Taki-arritmija ventrikulari
English: EU/1/03/248/009 2 tablets EU/1/03/248/010 4 tablets EU/1/03/248/011 8 tablets EU/1/03/248/012 12 tablets EU/1/03/248/023 20 tablets
Maltese: EU/1/03/248/009 2 pilloli EU/1/03/248/010 4 pilloli EU/1/03/248/011 8 pilloli EU/1/03/248/012 12-il pillola EU/1/03/248/023 20 pillola
English: An additional analysis, including data from clinical trials, post marketing experience and literature showed that some occurred with a close temporal association (the two first weeks) after the intake of vardenafil.
Maltese: Analiżi addizzjonali, inkluża data minn provi kliniċi, esperjenza ta' wara t-tqegħid fis-suq u mil-letteratura wriet li xi wħud seħħew b'assoċjazzjoni temporali mill-qrib (fl-ewwel ġimagħtejn) wara t-teħid ta' vardenafil.
English: At a dose of 20 mg Levitra film-coated tablets, elderly (≥ 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years old).
Maltese: B'doża ta' 20 mg Levitra pilloli miksija b'rita, pazjenti anzjani (età ta' ≥65 sena) kellhom frekwenzi ogħla ta' uġigħ ta' ras (16.2% kontra 11.8%) u sturdament (3.7% kontra 0,7%) minn pazjenti iżgħar (età ta' <65 sena).
English: Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax.
Maltese: Meta vardenafil (5 mg) ingħata flimkien ma' erythromycin (500 mg tliet darbiet kuljum), inibitur ta' CYP3A4, l-AUC ta' vardenafil żdiedet b'4 darbiet, waqt li Cmax żdiedet bi 3 darbiet.
English: EU/1/03/248/005 2 tablets EU/1/03/248/006 4 tablets EU/1/03/248/007 8 tablets EU/1/03/248/008 12 tablets EU/1/03/248/022 20 tablets
Maltese: EU/1/03/248/005 2 pilloli EU/1/03/248/006 4 pilloli EU/1/03/248/007 8 pilloli EU/1/03/248/008 12-il pillola EU/1/03/248/022 20 pillola
English: Pharmacokinetics in special patient groups
Maltese: Farmakokinetika fi gruppi speċjali ta' pazjenti
English: Effects on the QT interval were measured one hour post-dose (average tmax for vardenafil).
Maltese: Effetti fuq l-intervall QT ġew imkejla siegħa wara li ngħatat id-doża (tmax medja ta' vardenafil).
English: - If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
Maltese: - Jekk għandek 'l fuq minn 75 sena u qed tieħu ketoconazole jew itraconazole, mediċini kontra l moffa.
English: (cannot be estimated from the available data)
Maltese: (ara s-sezzjoni Mediċini oħra u Levitra).
English: These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.
Maltese: Dawn l-effetti huma konsistenti ma' l-effetti vażodilatatorji ta' l-inibituri ta' PDE5 u probabbilment dan iseħħ minħabba ż-żjieda fil-livelli ta' cGMP fiċ-ċelloli vaskulari tal-muskoli lixxi.
English: Hypromellose Titanium dioxide (E171) Ferric oxide yellow (E172) Ferric oxide red (E172)
Maltese: Ferric oxide aħmar (E172)
English: - Alcoholic drink can make erection difficulties worse.
Maltese: - Xorb alkoħoliku jista' jżid id-diffikultajiet fl-erezzjoni.
English: EU/1/03/248/001-004, 021 EU/1/03/248/005-008, 022 EU/1/03/248/009-012, 023
Maltese: EU/1/03/248/005-008, 022
English: In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing.
Maltese: Fi studju plestismografu (RigiScan) tal-pene, vardenafil 20 mg wassal għal erezzjonijiet meqjusa bħala suffiċjenti għall-penetrazzjoni (riġidita' ta' 60% b'RigiScan).
English: In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3).
Maltese: F'irġiel akbar minn 75 sena, l-użu ta' vardenafil flimkien ma' itraconazole jew ketoconazole huwa kontra-indikat (ara sezzjoni 4.3).
English: The mean maximum decreases in supine systolic blood pressure following 20 mg and 40 mg vardenafil were - 6.9 mmHg under 20 mg and - 4.3 mmHg under 40 mg of vardenafil, when compared to placebo.
Maltese: Meta mqabbel mal-plaċebo, il-pressjoni sistolika ta' meta wieħed ikun mimdud naqset b'medja massima ta' -6.9 mmHg meta ngħatat 20 mg u -4.3 mmHg meta ngħatat 40 mg ta' vardenafil.
English: The relative bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil (20 mg).
Maltese: Ilbiodisponibiltà relattiva ta' glibenclamide (3. 5 mg) ma nbidlitx meta ngħata flimkien ma' vardenafil (20 mg).
English: Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥65 years old) (see sections 4.2 and 4.8).
Maltese: It-tollerabilità tad-doża massima ta' Levitra 20 mg pilloli miksija b'rita tista' tkun aktar baxxa f'pazjenti anzjani (età ≥65 sena) (ara sezzjonijiet 4.2 u 4.8).
English: EU/1/03/248/001 2 tablets EU/1/03/248/002 4 tablets EU/1/03/248/003 8 tablets EU/1/03/248/004 12 tablets EU/1/03/248/021 20 tablets
Maltese: EU/1/03/248/001 2 pilloli EU/1/03/248/002 4 pilloli EU/1/03/248/003 8 pilloli EU/1/03/248/004 12-il pillola EU/1/03/248/021 20 pillola
English: A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration compared to 44% of all attempts in the placebo group.
Maltese: Persentaġġ ta' 71% tat-tentattivi sesswali kollha rrappurtati fil-provi kliniċi kellhom penetrazzjoni b'suċċess meta mqabbel ma' 44% tat-tentattivi kollha fil-grupp tal-plaċebo.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Maltese: Għalkemm ma twettqux studji speċifiċi ta' interazzjoni għall-mediċini kollha, analiżi farmakokinetika tal-popolazzjoni ma wriet l-ebda effett fuq il-farmakokinetika ta' vardenafil meta ngħata flimkien ma' dawn il-mediċini: acetylsalicylic acid, inibituri ACE, beta-blokers, inibituri ħfief ta' CYP3A4, dijuretiċi, u prodotti mediċinali għall-kura tad-dijabete (sulfonylureas u metformin).
English: 1 x 1 orodispersible tablet in alu/alu perforated unit dose blister, 2 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters, 8 x 1 orodispersible tablets in alu/alu perforated unit dose blisters.
Maltese: 1 x 1 pillola li tinħall fil-ħalq f'folja pperforata magħmula minn alu/alu b'doża waħda, 2 x 1 pilloli li jinħallu fil-ħalq f'folji pperforati magħmula minn alu/alu b'doża waħda, 4 x 1 pilloli li jinħallu fil-ħalq f'folji pperforati magħmula minn alu/alu b'doża waħda, 8 x 1 pilloli li jinħallu fil-ħalq f'folji pperforati magħmula minn alu/alu b'doża waħda.
English: - If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite.
Maltese: - Nitrates, mediċini għall-anġina, jew donaturi ta' nitric oxide bħal amyl nitrite.