FrancophonIA/ELRC3.0 huggingface dataset:
English: Vardenafil pharmacokinetics has not been studied in patients requiring dialysis (see section 4.3).
Maltese: Il-farmakokinetika ta' vardenafil ma ġietx studjata f'pazjenti li jinħtieġu d-dijalisi (ara sezzjoni 4.3).
English: Levitra 10 mg orodispersible tablets are not for use in patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C; see section 4.3).
Maltese: Levitra 10 mg pilloli li jinħallu fil-ħalq mhux indikati għall-użu f'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh B) u sever (Child-Pugh C; ara sezzjoni 4.3).
English: How to store Levitra
Maltese: DATA TA' SKADENZA
English: However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Maltese: Madankollu, f'90% tad-drabi, fi stat sajjem, l-ogħla konċentrazzjonijiet fil-plażma jintlaħqu minn 30 sa 120 minuta (medjan 60 minuta) wara li tingħata d-doża mill-ħalq.
English: Suomi/Finland
Maltese: Suomi/Finland Bayer Oy
English: Parts of M1 are in the form of the glucuronide in systemic circulation.
Maltese: Partijiet minn M1 jinsabu bħala glucuronide fiċ-ċirkolazzjoni sistemika.
English: Vardenafil potently enhances the effect of endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5.
Maltese: Vardenafil iżid b'mod qawwi l-effett ta' nitric oxide fil-korpus kavernożum billi jimpedixxi lil PDE5.
English: The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.
Maltese: Għall-pazjenti li temmew tliet xhur ta' kura, r-rati ta' ħila biex tintlaħaq u tinżamm erezzjoni tal-pene kienu ta' 61% u 49% b'10 mg u 64% u 54% b'20 mg vardenafil, meta mqabbla ma' 36% u 23% bilplaċebo.
English: Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax (see section
Maltese: Meta vardenafil (5 mg) ingħata flimkien ma' ketoconazole (200 mg) li hu inibitur qawwi ta' CYP3A4, l-AUC ta' vardenafil żdiedet b'10 darbiet, waqt li Cmax żdiedet b'4 darbiet (ara sezzjoni 4.4).
English: Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Maltese: Kaiser-Wilhelm-Allee
English: Erythema Rash
Maltese: Eritema Raxx
English: No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or digoxin (0.375 mg) was co-administered with vardenafil (20 mg film-coated tablets).
Maltese: Ma kienx hemm interazzjonijiet sinifikanti meta vardenafil (20 mg pilloli miksija b'rita) ingħata flimkien ma' warfarin (25 mg), li jiġi metabolizzat minn CYP2C9, jew digoxin (0.375 mg).
English: PDE5 inhibitors, such as Levitra have been shown to increase the hypotensive effects of this medicine.
Maltese: Inibituri ta' PDE5, bħal Levitra intwerew li jżidu l-effetti ta' tnaqqis tal-pressjoni ta' din il-mediċina.
English: Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol.
Maltese: Levitra 10 mg pilloli li jinħallu fil-ħalq fihom Aspartame u Sorbitol.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Sorsi oħra ta' informazzjoni Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: In single dose volunteer studies, doses up to and including 80 mg vardenafil (film-coated tablets) per day were tolerated without exhibiting serious adverse reactions.
Maltese: Fi studji kliniċi b'voluntiera li ngħataw doża waħda, dożi sa u inkluż 80 mg vardenafil (pilloli miksija b'rita) kuljum kienu ttollerati mingħajr ma ħolqu reazzjonijiet avversi serji.
English: Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg.
Maltese: Skont kemm tkun ittollerata u effettiva, id-doża tista' tiġi miżjuda għal 10 mg u 20 mg.
English: The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.
Maltese: Għall-pazjenti li temmew tliet xhur ta' kura, r-rati tal-ħila biex tintlaħaq u tinżamm erezzjoni tal-pene kienu ta' 47% u 37% b'10 mg u 48% u 34% b'20 mg vardenafil, meta mqabbla ma' 22% u 10% bil-plaċebo.
English: About 63% of all reported sexual attempts with vardenafil 10 mg orodispersible tablets were successful in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts.
Maltese: Madwar 63% ta' kull tentattiv sesswali rrappurtat b'vardenafil 10 mg pilloli li jinħallu fil-ħalq kellhom suċċess f'termini ta' żamma ta' erezzjoni meta mqabbel ma' madwar 26% tat-tentattivi sesswali kollha kkontrollati bil-plaċebo.
English: Each tablet of 20 mg film-coated tablets contains 20 mg of vardenafil (as hydrochloride).
Maltese: Kull pillola ta' 20 mg pilloli miksija b'rita fiha 20 mg ta' vardenafil (bħala hydrochloride).
English: Levitra 20 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “20” on the other side.
Maltese: Pilloli tondi, oranġjo immarkati bis-salib tal-BAYER fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: may affect up to 1 in 100 users - Swelling of skin and mucous tissue including swollen face, lips or throat - Sleep disorder - Numbness and impaired perception of touch - Sleepiness - Effects on vision, redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity - Ringing in the ears, vertigo - Fast heart beat or pounding heart - Breathlessness - Stuffy nose - Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth - Raised levels of liver enzymes in your blood - Rash, reddened skin - Back or muscle pain, increase in blood of a muscle enzyme (creatine phosphokinase), muscle stiffness - Prolonged erections - Malaise
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100 li qed jużawh - Nefħa fil-ġilda u fit-tessut mukuż inkluż nefħa fil-wiċċ, xufftejn jew griżmejn - Disturb fl-irqad - Tnemnim u perċezzjoni mnaqqsa tal-mess - Ħedla ta' ngħas - Effetti fuq il-vista, ħmura fl-għajn, effetti fuq il-ħila biex tagħraf il-kuluri, uġigħ u skomdu fl għajn, sensittività għad-dawl
English: In volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment.
Maltese: F'voluntiera b'indeboliment renali sever (tneħħija tal-krejatinina <30 ml/min), l-AUC medja żdiedet b'21% u s-Cmax naqset b'34% meta mqabbla ma' voluntiera b'funzjoni renali normali.
English: - If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
Maltese: l-għajnejn (bħal retinitis pigmentosa).
English: Effect on vision
Maltese: Disturbi fil-vista
English: Amnesia Transient ischaemic attack
Maltese: Amnesija Attakk iskemiku temporanju
English: When nitric oxide is released in response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum levels of cGMP.
Maltese: Meta jinħeles nitric oxide b'reazzjoni għal stimulazzjoni sesswali, l-impediment ta' PDE5 minn vardenafil jirriżulta f'żjieda fil-livelli ta' cGMP fil-korpus kavernożum.
English: The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).
Maltese: hija ta' 10 mg (ara sezzjonijiet 4.3 u 5.2).
English: Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with vardenafil 5 mg.
Maltese: Meta vardenafil 5 mg ingħata flimkien ma' ritanovir (600 mg darbtejn kuljum), Cmax ta' vardenafil żdiedet bi 13-il darba u l-AUC0-24 ta' vardenafil żdiedet b'49 darba.
English: Levitra 5 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “5” on the other side.
Maltese: Pilloli tondi, oranġjo immarkati bis-salib tal-BAYER fuq naħa waħda u “5” fuq in-naħa l-oħra.
English: The following adverse reactions have been reported:
Maltese: Ġew irrappurtati r-reazzjonijiet avversi li ġejjin:
English: If vardenafil 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax remains unchanged and median tmax is shortened by 60 minutes compared to intake without water.
Maltese: Jekk vardenafil 10 mg pilloli li jinħallu fil-ħalq jittieħdu bl-ilma, l-AUC tonqos b'29%, Cmax ma tinbidilx u tmax medjan jonqos b'60 minuta meta mqabbla ma' teħid mingħajr ilma.
English: In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.
Maltese: Fi studju separat ta' wara t-tqegħid fuq is-suq f'44 volontiera b'saħħithom, dożi individwali ta' 10 mg varadenafil jew ta' 50 mg sildenafil ġew mogħtija flimkien ma' 400 mg gatifloxacin, mediċina b'effett QT komparabbli.
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 IA (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
English: Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18 - 45 years).
Maltese: It-tneħħija mill-fwied ta' vardenafil f'voluntiera anzjani b'saħħithom (minn 65 sena 'l fuq) kienet inqas meta mqabbla ma' voluntiera iżgħar b'saħħithom (18 - 45 sena).
English: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.
Maltese: Din il-mediċina fiha 1.80 mg ta' aspartame f'kull pillola li tinħall fil-ħalq ta' 10 mg.
English: When used in combination with a moderate CYP3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be necessary (see sections 4.2 and 4.4).
Maltese: Meta mogħti flimkien ma' inibitur moderat ta' CYP3A4, bħal erythromycin jew clarithromycin, għandu mnejn ikun hemm bżonn aġġustament fid-doża ta' vardenafil (ara sezzjoni 4.2 u sezzjoni 4.4).
English: Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 inhibitor, with vardenafil (10 mg film-coated tablets) resulted in a 16-fold increase in vardenafil AUC and a 7-fold increase in vardenafil Cmax.
Maltese: Meta vardenafil (10 mg pilloli miksija b'rita) ingħata flimkien ma' indinavir (800 mg tliet darbiet kuljum), inibitur ta' HIV protease, u inibitur qawwi ta' CYP3A4, l-AUC ta' vardenafil żdiedet b'16-il darba u Cmax ta' vardenafil żdiedet b'7 darbiet.
English: Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Maltese: Vardenafil u l-metabolit prinċipali tiegħu li jkun fiċ-ċirkolazzjoni (M1), huma marbuta b'mod qawwi mal-proteini tal-plażma (madwar 95% għal vardenafil jew M1).
English: Film-coated tablet.
Maltese: Pilloli tondi u bojod.
English: Film coat:
Maltese: Puh/Tel:
English: Each tablet contains 20 mg vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 20 mg Vardenafil (bħala hydrochloride).
English: Tел.
Maltese: Tqalligħ
English: Crospovidone Magnesium stearate Microcrystalline cellulose Silica, colloidal anhydrous
Maltese: Microcrystalline cellulose
English: At tmax, only the mean change in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI: 8-11).
Maltese: F'tmax, il-bidla medja f'QTcF għal 80 mg vardenafil biss kienet barra mill-limitu stabbilit ta' l-istudju (medja 10 msec, 90% CI:8-11).
English: Levitra 10 mg orodispersible tablets vardenafil
Maltese: Levitra 10 mg, pilloli miksija b'rita vardenafil
English: Priapism Penile Haemorrhage Haematospermia
Maltese: Reazzjoni allerġika Ansjetà
English: Nausea
Maltese: Priapiżmu
English: The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 4-5 hours.
Maltese: It-tneħħija totali ta' vardenafil mill-ġisem hija ta' 56 l/h li tirriżulta f'half-life terminali ta' madwar 4-5 sigħat.
English: Levitra 10 mg film-coated tablets Orange round tablets marked with the BAYER-cross on one side and “10” on the other side.
Maltese: Pilloli tondi, oranġjo immarkati bis-salib tal-BAYER fuq naħa waħda u “10” fuq in-naħa l-oħra.
English: - If you have stomach ulcers (also called gastric or peptic ulcers).
Maltese: (Dawn jissejħu wkoll ulceri gastriċi jew peptiċi).
English: The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni medju fi stat stabbli huwa ta' 208 lt.
English: When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg (see section 4.5).
Maltese: Meta jingħata flimkien ma' inibituri tas-CYP3A4 bħal erythromycin jew clarithromycin, id-doża ta' vardenafil m'għandhiex tkun aktar minn 5 mg (ara sezzjoni 4.5).
English: This includes conditions called angulation, Peyronie's disease and cavernosal fibrosis.
Maltese: Dan jinkludi kundizzjonijiet imsejħa angulazzjoni, il-marda ta' Peyronie u fibrożi fil-korpus kavernożum.
English: This drug 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 tikkura pressjoni għolja fl-arterja tal pulmum (jiġifieri pressjoni għolja fil-pulmun) u pressjoni tromboembolika għolja kronika filpulmun (jiġifieri pressjoni għolja fil-pulmun kkawżata minn emboli tad-demm).
English: Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours.
Maltese: Ma ġietx osservata pressjoni baxxa meta l-għoti ta' vardenafil 5 mg u terazosin kien separat b'6 sigħat.
English: On average elderly males taking vardenafil film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2).
Maltese: Irġiel anzjani li jieħdu vardenafil pilloli miksija b'rita kellhom AUC ogħla b'medja ta' 52% u Cmax ogħla b'34% meta mqabbla ma' rġiel iżgħar (ara sezzjoni 4.2).
English: Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil (as hydrochloride).
Maltese: Kull pillola ta' 5 mg pilloli miksija b'rita fiha 5 mg ta' vardenafil (bħala hydrochloride).
English: Priapism Penile Haemorrhage Haematosperm ia
Maltese: Jekk għandek ulċeri fl-istonku.
English: There are no fertility data available.
Maltese: M'hemmx disponibbli dejta dwar il-fertilità.
English: Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
Maltese: Emorraġija mill-pene, ematospermja u ematurja ġew irrappurtati fi provi kliniċi u dejta spontanja ta' wara t-tqegħid fis-suq bl-użu tal-inibituri ta' PDE5 kollha, inkluż vardenafil.
English: Tolerability of the maximum dose of Levitra 20 mg film-coated tablets may be lower in elderly patients
Maltese: It-tollerabilità tad-doża massima ta' 20 mg tista' tkun aktar baxxa f'pazjenti anzjani (età ≥65 sena)
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Maltese: Uroloġiċi, Mediċini wżati għall-kura tal-problema ta' l-erezzjoni talpene, Kodiċi ATC:
English: - If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
Maltese: - Jekk qed tieħu ritanovir jew indinavir, mediċini wżati għall-kura ta' infezzjonijiet tal-virus tal immunodefiċjenza umana (HIV).
English: Concomitant use of vardenafil with potent CYP3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the medicinal products are combined (see sections 4.5 and 4.3).
Maltese: L-użu ta' vardenafil flimkien ma' inibituri qawwija ta' CYP3A4 bħal itraconazole u ketoconazole (ilforma li tittieħed mill-ħalq) għandu jiġi evitat għax l-għoti flimkien ta' dawn il-prodotti mediċinali jirriżulta fl-livelli ta' vardenafil fil-plażma għoljin ħafna (ara sezzjonijiet 4.5 u 4.3).
English: labyrinth disorders
Maltese: Anġina pectoris
English: In patients with mild hepatic impairment (Child-Pugh A), the mean AUC and Cmax increased by 17% and 22% respectively, compared to healthy control subjects.
Maltese: F'pazjenti li kellhom indeboliment tal-fwied ħafif (Child-Pugh A), l-AUC medja għoliet b'17% u s-Cmax għoliet b' 22% meta mqabbla ma' grupp ta' kontroll ta' rġiel b'saħħithom.
English: Vardenafil 20 mg film-coated tablets potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) taken 1 and 4 hours after vardenafil administration to healthy middle aged subjects.
Maltese: Vardenafil 20mg pilloli miksija b'rita qawwa l-effett li jbaxxi l-pressjoni ta' nitroglicerine (0.4 mg) mogħti taħt lilsien wara siegħa u 4 sigħat mill-għoti ta' vardenafil f'pazjenti b'saħħithom ta' mezz' età.
English: In fixed dose studies (film-coated tablets) in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period.
Maltese: Fi studji mifruxa fuq tliet xhur li saru bl-użu ta' doża fissa (pilloli miksija b'rita) f'popolazzjoni b'firxa kbira ta' rġiel bil-problema ta' l-erezzjoni tal-pene, 68% (5 mg), 76% (10 mg) u 80% (20 mg) tal-pazjenti kellhom suċċess tal-penetrazzjoni (SEP2), meta mqabbel ma' 49% li kienu fuq plaċebo.
English: No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2).
Maltese: (AUC u Cmax) (ara sezzjoni 4.2).
English: Treatment of erectile dysfunction in adult men.
Maltese: Kura għal problema ta' l-erezzjoni tal-pene fl-irġiel adulti.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Maltese: Ma kien hemm l-ebda evidenza ta' effett kliniku favorevoli talkombinazzjoni fil-popolazzjoni studjata.
English: Medicinal products for the treatment of erectile dysfunction 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: Prodotti mediċinali għall-kura tal-problema ta' l-erezzjoni tal-pene għandhom jintuzaw b'aktar attenzjoni f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrożi fil-korpus kavernożum jew il-marda ta' Peyronie), jew f'pazjenti li jsofru minn mard li minħabba fih hemm probabilità akbar li jkollhom prijapiżmu (bħal anemija sickle cell, majeloma multipla jew lewkimja).
English: Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest increases in plasma levels of vardenafil (see section 4.4).
Maltese: Meraq tal-grejpfrut huwa inibitur ħafif tal-metaboliżmu ta' CYP3A4 fl-imsaren, u b'hekk jista' jżid bi ftit il-livelli ta' vardenafil fil-plażma (ara sezzjoni 4.4).
English: Bayer Hispania S.L.
Maltese: Bayer S.p.A.
English: Levitra 20 mg film-coated tablets vardenafil
Maltese: Levitra 20 mg pilloli miksija b'rita Vardenafil
English: Hypotension Hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Some medicines may cause problems, especially these: - Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite.
Maltese: Nitrates, mediċini għall-anġina, jew donaturi ta' nitric oxide bħal amyl nitrite.
English: In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half-life of approximately 4 hours.
Maltese: Fil-bnedmin, il-metabolit prinċipali li jiċċirkola fid-demm (M1) jifforma minn desethylation ta' vardenafil u jkompli jiġi metabolizzat, b'half-life ta' eliminazzjoni mill-plażma ta' madwar 4 sigħat.
English: Levitra 10 mg orodispersible tablets
Maltese: Levitra 10 mg pilloli miksija b'rita
English: Levitra 10 mg orodispersible tablets are not bioequivalent to Levitra 10 mg film-coated tablets (see section 5.1).
Maltese: Levitra10 mg bħala pilloli miksija b'rita (ara sezzjoni 5.2).
English: Medicinal products for the treatment of erectile dysfunction should generally not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).
Maltese: Prodotti mediċinali għall-kura tal-problema ta' l-erezzjoni tal-pene ġeneralment m'għandhomx jintużaw f'irġiel li għalihom attività sesswali mhix irrakkomandata (eżempju, pazjenti b'disturbi kardjovaskulari severi, bħal anġina instabbli, jew insuffiċjenza kardijaka severa [New York Heart Association III jew IV])
English: Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see section 4.2 and 4.5).
Maltese: Jista' jkun hemm bżonn tibdil fid-doża ta' vardenafil meta jingħata flimkien ma' inibituri moderati ta' CYP3A4 bħal ma huma erythromycin u clarithromycin (ara sezzjoni 4.5 u sezzjoni 4.2).
English: Levitra is contraindicated in 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 phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
Maltese: Difetti fil-vista u każijiet ta' newropatija ottika iskemika mhux arterika (NAION) ġew irrappurtati f'konnessjoni ma' l-użu ta' Levitra u inibituri ta' PDE5 oħra.
English: Levitra 10 mg film-coated tablets vardenafil
Maltese: Levitra 10 mg pilloli li jinħallu fil-ħalq Vardenafil
English: The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).
Maltese: Il-gruppi ta' pazjenti li ġejjin ma kienux rappreżentati tajjeb fil-provi kliniċi: anzjani (>75 sena, 2.4%), u pazjenti b'ċerti tipi ta' mard kardjovaskulari (ara sezzjoni 4.3).
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Maltese: Fi studji kliniċi, riociguat intwera li jkabbar l-effetti ta' tnaqqis tal-pressjoni ta' inibituri ta' PDE5.
English: After oral administration, vardenafil is excreted as metabolites predominantly in the faeces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose).
Maltese: Wara għoti mill-ħalq, vardenafil jitneħħa l-aktar bħala metaboliti fl-ippurgar (madwar 91-95% tad-doża li tingħata), u b'mod anqas fl-urina (madwar 2-6% tad-doża li tingħata).
English: Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 years or over following once-daily dosing of vardenafil 10 mg orodispersible tablets over ten days.
Maltese: Vardenafil ma nstabx li jakkumula fil-plażma f'pazjenti b'età ta' 45 sena jew anqas jew 65 sena jew aktar wara dożaġġ ta' darba kuljum ta' vardenafil 10 mg pilloli li jinħallu filħalq fuq medda ta' għaxart ijiem.
English: Each tablet contains 5 mg vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 5 mg vardenafil (bħala hydrochloride).
English: The clinical impact of these QT changes is unknown (see section 5.1).
Maltese: L-impatt kliniku ta' dan it-tibdil fil-QT mhux magħruf (ara sezzjoni 5.1).