FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/637/001 (10 mg, 30 pilloli miksija b'rita) EU/1/10/637/002 (10 mg, 60 pilloli miksija b'rita) EU/1/10/637/004 (10 mg, 100 pilloli miksija b'rita)
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 15 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Leflunomide medac 15 mg pilloli miksija b'rita
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (tista' taffettwa sa 1 minn kull 1,000 persuna)
English: Gastrointestinal disorders
Maltese: Mhux magħruf ipertensjoni pulmonari Disturbi gastro-intestinali
English: A more than 3-fold increase was seen in another 5 patients.
Maltese: Kien hemm żieda ta' aktar minn 3 darbiet f' 5 pazjenti oħra.
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 10 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Leflunomide medac 10 mg pilloli miksija b'rita
English: • Keep this leaflet.
Maltese: • Nisa li qed ireddgħu.
English: • if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Maltese: • jekk tiżviluppa raxx fil-ġilda jew ulċeri f'ħalqek, billi dawn jistgħu jindikaw reazzjonijiet severi u xi kultant fatali (e.ż. is-sindrome ta' Stevens-Johnson, in-nekrosi tossika u esfoljattiva tal-ġilda, eritema multiforme, Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi [DRESS]), ara sezzjoni 2.
English: • abdominal pain,
Maltese: • disturbi fit-tegħim,
English: Cases of peripheral neuropathy have been reported in patients receiving Leflunomide medac.
Maltese: Ġew irrappurtati każijiet ta' newropatija periferika f'pazjenti li rċevew Leflunomide medac.
English: Leflunomide medac is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Maltese: Leflunomide medac mhux irrakkomandat għall-użu f'pazjenti taħt it-18-il sena għax l-effikaċja u s-sigurtà fl-artrite rewmatika fiż-żgħażagħ (JRA) mhumiex stabbiliti (ara sezzjoni 5.1 u 5.2).
English: Leflunomide is indicated for the treatment of adult patients with:
Maltese: Leflunomide huwa indikat għall-kura ta' pazjenti adulti li jbatu minn:
English: Leflunomide medac 15 mg film-coated tablets are white to almost white and round with a diameter of about 7 mm. One side of the tablet is debossed with “15”.
Maltese: Pillola miksija b'rita, bajda jew kważi bajda, tonda, b'dijametru ta' madwar 7 mm; naħa waħda tal-pillola hemm intaljat fuqha l-kodiċi “15”.
English: Human pharmacology Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Maltese: Leflunomide ma kienx antiġeniku fi provi fuq l-annimali.
English: Pregnancy
Maltese: ipojuriċimja
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Maltese: It-teħid flimkien ta' mediċini tal-klassi tad-DMARD li huma tossiċi għall-fwied u għad-demm (e.g. methotrexate) mhux irrakkomandat.
English: Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Maltese: Dan jista' ma jiżgurax kontraċezzjoni ta' min jorbot fuqha, bilkontraċettivi orali, waqt il-proċedura tat-tneħħija bil-colestyramine u trab ta' charcoal mediċinali attivat .
English: Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin.
Maltese: Kull pillola miksija b'rita fiha 152 mg ta' lactose (bħala monohydrate) u 0.
English: Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).
Maltese: Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa sentejn wara it-trattament (ara “perijodu ta' stennija” hawn isfel), jew sa 11-il jum wara it-trattament (ara “ż-żmien imqassar biex jitneħħa leflunomide”, hawn isfel).
English: • an increase in the levels of fat in the blood (cholesterol and triglycerides),
Maltese: • żieda fil-livelli tax-xaħam fid-demm (il-kolesterol u t-trigliċeridi),
English: • tiredness (asthenia),
Maltese: • għeja (astenja),
English: Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Maltese: Qabel ma tinbeda l-kura, il-pazjenti kollha għandhom jiġu evalwati għal tuberkulosi attiva jew inattiva (“rieqda”), skont ir-rakkomandazzjonijiet lokali.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi rari u ereditarji t'intolleranza għall-galaktosju, id-defiċjenza ta' l-enżima lactase tat-tip Lapp, jew il-malassorbiment tal-glukusju-galaktosju, m'għandhomx jieħdu dan il-prodott mediċinali.
English: Date of first authorisation: 4 March 2003 Date of latest renewal: 4 March 2008
Maltese: Data tal-aħħar tiġdid: 4 ta' Marzu 2008
English: Photosensitivity reaction
Maltese: fotosensittività
English: Vivanza contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
Maltese: Vivanza fih vardenafil, membru ta' klassi ta' mediċini msejħa inibituri ta' phosphodiesterase tip 5.
English: Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421) sorbitol (E420), crospovidone and silica colloidal hydrated.
Maltese: Magnesium stearate, aspartame (E951), benna tal-pepermint, mannitol (E421) sorbitol (E420), crospovidone u colloidal silica anidru.
English: Vivanza will only work when you are sexually stimulated.
Maltese: Vivanza jaħdem biss meta int tkun sesswalment stimulat.
English: PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets.
Maltese: Il-pilloli huma pprovduti f'pakketti tal-folja b'folji 2, 4, 8, 12 jew 20 pillola.
English: Take special care with Vivanza
Maltese: Mediċini oħra u Vivanza
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Maltese: Ir-reazzjonijiet avversi huma mniżżla 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) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Concomitant use of CYP3A4 inhibitors
Maltese: Użu flimkien ta' inibituri ta' CYP3A4
English: • When vardenafil 5 mg (film-coated tablets) was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension.
Maltese: • Meta vardenafil 5 mg (pilloli miksija b'rita) ingħata flimkien ma' terazosin 5 jew 10 mg, wieħed minn 21 pazjent kellu pressjoni baxxa sintomatika bil-wieqfa.
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: - Taħbit mgħaġġel tal-qalb jew tħoss qalbek ser toħroġ minn sidrek - Qtugħ ta' nifs - Imnieħer miżdud - Rifluss tal-aċidu, gastrite, uġigħ ta' żaqq, dijarea, rimettar, tħossok ma tiflaħx (tqalligħ), ħalq xott - Livelli miżjuda tal-enzimi tal-fwied fid-demm tiegħek - Raxx, ħmura tal-ġilda - Uġigħ fid-dahar jew fil-muskoli, żjieda ta' enzima tal-muskoli fid-demm (creatine phosphokinase), egħbusija tal-muskoli - Erezzjonijiet imtawwla - Tħossok ma tiflaħx
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 lintervall 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: See section 2 “Vivanza 10 mg orodispersible tablets contain Aspartame and Sorbitol”.
Maltese: Ara sezzjoni 2 “Vivanza 10 mg pilloli li jinħallu fil-ħalq fihom Aspartame u Sorbitol”.
English: Vivanza 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: Vivanza 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: Priapism Penile Haemorrhage Haematosper mia
Maltese: Kif gћandek tieћu Vivanza
English: EU/1/03/249/009 2 tablets EU/1/03/249/010 4 tablets EU/1/03/249/011 8 tablets EU/1/03/249/012 12 tablets EU/1/03/249/015 20 tablets
Maltese: EU/1/03/249/009 2 pilloli EU/1/03/249/010 4 pilloli EU/1/03/249/011 8 pilloli EU/1/03/249/012 12-il pillola EU/1/03/249/015 20
English: EU/1/03/249/005 2 tablets EU/1/03/249/006 4 tablets EU/1/03/249/007 8 tablets EU/1/03/249/008 12 tablets EU/1/03/249/014 20 tablets
Maltese: EU/1/03/249/005 2 pilloli EU/1/03/249/006 4 pilloli EU/1/03/249/007 8 pilloli EU/1/03/249/008 12-il pillola EU/1/03/249/014 20 pillola
English: Aspartame (E951) Peppermint flavour Magnesium stearate Crospovidone Mannitol (E421) Silica colloidal hydrated Sorbitol (E420)
Maltese: Crospovidone Mannitol (E421) Silica colloidal anidru Sorbitol (E420)
English: Take a Vivanza tablet about 25 to 60 minutes before sexual activity.
Maltese: Ħu pillola Vivanza madwar 25 sa 60 minuta qabel attività sesswali.
English: Jenapharm GmbH & Co. KG Tel: +49 (0)3641 64 8888
Maltese: KG Tel: +49 (0)3641 64 8888
English: Sorbitol This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.
Maltese: Sorbitol Din il-mediċina fiha sorbitol 7.96 mg f'kull pillola li tinħall fil-ħalq ta' 10 mg.
English: EU/1/03/249/001 2 tablets EU/1/03/249/002 4 tablets EU/1/03/249/003 8 tablets EU/1/03/249/004 12 tablets EU/1/03/249/013 20 tablets
Maltese: EU/1/03/249/001 2 pilloli EU/1/03/249/002 4 pilloli EU/1/03/249/003 8 pilloli EU/1/03/249/004 12-il pillola EU/1/03/249/013 20 pillola
English: Vascular disorders
Maltese: anterjuri Difetti filvista
English: Vivanza 10 mg orodispersible tablets are not bioequivalent to Vivanza 10 mg film-coated tablets (see section 5.1).
Maltese: Vivanza 10 mg pilloli li jinħallu fil-ħalq mhux bijoekwivalenti għal Vivanza 10 mg pilloli miksija b'rita (ara sezzjoni 5.1).
English: Tel: + 385-(0)1-6599 900
Maltese: Bayer d.o.o. Tel: + 385-(0)1-6599 900
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 mal-effett ta' kull 400 mg gatifloxacin, sustanza attiva b'effett QT komparabbli, uriet effett QTc addizzjonali ta' 4 msec meta mqabbel ma' waħda minn dawn is-sustanzi attivi ndividwalment.
English: Tinnitus Vertigo
Maltese: Vertigo
English: Tolerability of the maximum dose of Vivanza 20 mg film-coated tablets may be lower in elderly patients (≥65 years old) (see sections 4.2 and 4.8).
Maltese: It-tollerabilità tad-doża massima ta' 20 mg tista' tkun aktar baxxa f'pazjenti anzjani (età ≥65 sena) (ara sezzjonijiet 4.2 u 4.8).
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: Hypromellose Titanium dioxide (E171) Ferric oxide yellow (E172) Ferric oxide red (E172)
Maltese: Titanium dioxide (E171)
English: m. b. H. Tel: +43-(0)1-711 46 0
Maltese: Bayer Austria Ges. m. b. H. Tel: +43-(0)1-711 46 0
English: - If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite.
Maltese: - Jekk qed tieħu mediċini li fihom nitrates, bħal glycerol trinitrate għall-anġina, jew donaturi ta' nitric oxide, bħal amyl nitrite.
English: At a dose of 20 mg Vivanza 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 Vivanza 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: At a dose of 20 mg Vivanza 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 Vivanza 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: 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 Fridericia QTc ta' 4 msec (vardenafil) u 5 msec (sildenafil) meta mqabbla ma' kull waħda mill-mediċini mogħtija waħidha.
English: With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vivanza.
Maltese: Bi stimulazzjoni sesswali jista' jkollok erezzjoni minn 25 minuta sa 4 jew 5 sigħat wara li tieħu l-pillola Vivanza.
English: The mean terminal half-life of vardenafil in patients receiving Vivanza 10 mg orodispersible tablets ranged between 4 - 6 hours.
Maltese: Il-half-life terminali medja ta' vardenafil f'pazjenti li rċevew Vivanza 10 mg pilloli li jinħallu fil-ħalq varjat minn 4-6 sigħat.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 20 film-coated tablets
Maltese: 8 pilloli miksija b'rita 12-il pilloli miksija b'rita 20 pillola miksija b'rita
English: PDE5 inhibitors, such as Vivanza have been shown to increase the hypotensive effects of this medicine.
Maltese: PDE5, bħal Vivanza intwerew li jżidu l-effetti ta' tnaqqis tal-pressjoni ta' din il-mediċina.
English: Diarrhoea
Maltese: Pillola
English: Vivanza is not indicated for individuals below 18 years of age.
Maltese: Vivanza mhux indikati għall-persuni b'età inqas minn 18-il sena.
English: Vivanza 10 mg film-coated tablets Vivanza 20 mg film-coated tablets
Maltese: Vivanza 5 mg pilloli miksija b'rita Vivanza 10 mg pilloli miksija b'rita Vivanza 20 mg pilloli miksija b'rita
English: Vivanza 10 mg orodispersible tablets vardenafil
Maltese: Vivanza 10 mg pilloli miksija b'rita vardenafil
English: Vardenafil in Vivanza 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 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: - 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
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: 30 sa 120 minuta (medjan 60 minuta) wara li tingħata d-doża mill-ħalq.
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: Vivanza 5 mg film-coated tablets Orange round tablets marked with 'v' on one side and “5” on the other side.
Maltese: Vivanza 5 mg pilloli miksija b'rita huma oranġjo immarkata b'‘v' fuq naħa waħda u (5) fuq in-naħa loħra.
English: - Aspartame: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.
Maltese: Aspartame Din il-mediċina fiha 1.80 mg ta' aspartame f'kull pillola li tinħall fil-ħalq ta' 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: 3A4 taċ-ċitokromju P450 (CYP) b'xi kontribuzzjoni mill-isoformi CYP3A5 u CYP2C.
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: Bijotrasformazzjoni Vardenafil f'Vivanza 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: Erythema Rash
Maltese: TAGĦRIF
English: Each tablet contains 20 mg vardenafil (as hydrochloride).
Maltese: Kull pillola fiha 20 mg vardenafil (bħala hydrochloride).
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: L-għola doża rrakkomandata f'pazjenti b'indeboliment tal-fwied moderat (Child-Pugh B) hija ta' 10 mg (ara sezzjonijiet 4.3 u 5.2).
English: • When vardenafil (film-coated tablets) was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg.
Maltese: • Meta vardenafil (pilloli miksija b'rita) ingħata f'dożi ta' 5, 10 jew 20 mg f'pazjenti li huma diġa' stabbli fuq terapija b'tamsulosin, ma kien hemm l-ebda tnaqqis sintomatiku fil-pressjoni tad-demm, għalkemm 3/21 pazjent kkurat b'tamsulosin kellhom pressjoni tad-demm sistolika temporanja bil-wieqfa ta' anqas minn 85 mmHg
English: Myocardial infarction Ventricular tachy-arrhythmi as
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI
English: Vivanza 20 mg film-coated tablets vardenafil
Maltese: Vivanza 20 mg pilloli miksija b'rita vardenafil
English: Vivanza 10 mg film-coated tablets Orange round tablets marked with 'v' on one side and “10” on the other side.
Maltese: Vivanza 10 mg pilloli miksija b'rita huma oranġjo immarkata b'‘v' fuq naħa waħda u (10) fuq in-naħa l-oħra.
English: The combination should be avoided (see section 4.5).
Maltese: (ara sezzjoni 4.5).
English: Vivanza 5 mg film-coated tablets vardenafil
Maltese: Vivanza 5 mg pilloli miksija b'rita vardenafil
English: Dyspepsia Gastro-oesophage al reflux disease Gastritis
Maltese: Uġigħ gastro intestinali u addominali Dijarea
English: Nasal congestion
Maltese: Disturbi filvista
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 20 mg pilloli miksija b'rita qawwa l-effett li jbaxxi l-pressjoni ta' nitroglicerine (0.4 mg) mogħti taħt l-ilsien wara siegħa u 4 sigħat mill-għoti ta' vardenafil f'pazjenti b'saħħithom ta' mezz' età.
English: Vivanza 10 mg orodispersible tablets are not indicated as a starting dose in patients with mild hepatic impairment (Child-Pugh A).
Maltese: Vivanza 10 mg pilloli li jinħallu fil-ħalq mhux indikati bħala doża tal-bidu f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh A).
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: 4 x 1 orodispersible tablets
Maltese: 4 pilloli miksija b'rita
English: Vivanza 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: Vivanza huwa kontra-indikat f'pazjenti li għandhom telf tal-vista f'għajn waħda minħabba newropatija ottika anterjuri iskemika mhux arteritika (NAION), kemm jekk dan l-episodju kien konness ma' espożizzjoni minn qabel għal inibitur ta' phosphodiesterase 5 (PDE5) kif ukoll jekk le (ara sezzjoni 4.4).
English: The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Maltese: Il-pilloli huma pprovduti f'pakketti b'folji li fihom 2, 4, 8, 12 jew 20 pillola.
English: Based on tolerability and efficacy, the dose may be increased to Vivanza 10 mg and 20 mg film-coated tablets, or Vivanza 10 mg orodispersible tablets.
Maltese: Skont kemm tkun ittollerata u effettiva, id-doża tista' tiġi miżjuda għal Vivanza 10 mg u 20 mg pilloli miksija b'rita, jew Vivanza 10 mg pilloli li jinħallu fil-ħalq.
English: If Vivanza 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 Vivanza 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: 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 Vivanza 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: Myocardial infarction Ventricular tachy-arrhythm ias
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali 3 snin
English: Crospovidone Magnesium stearate Microcrystalline cellulose Silica, colloidal anhydrous
Maltese: Microcrystalline cellulose.
English: 4 x 1 orodispersible tablets in alu/alu perforated unit dose blisters.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 4 x 1 pilloli li jinħallu fil-ħalq
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Vivanza 10 mg orodispersible tablets are taken as needed approximately 25 to 60 minutes before sexual activity.
Maltese: Vivanza 10 mg pilloli li jinħallu fil-ħalq jittieħdu skont il-bżonn madwar 25 sa 60 minuta qabel l-att sesswali.
English: Vivanza 20 mg film-coated tablets Orange round tablets marked with 'v' on one side and “20” on the other side.
Maltese: Pilloli tondi, oranġjo immarkata b''v' fuq naħa waħda u “20” fuq in-naħa l-oħra.