FrancophonIA/ELRC3.0 huggingface dataset:
English: Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrallyacting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Maltese: Ġabra tal-klassijiet li ġejjin ta' mediċini li jaġixxu kontra l-pressjoni għolja; dijuretiċi, beta-blokers, inibituri ta' ACE, antagonisti ta' angiotensin II, prodotti mediċinali kontra l-pressjoni għolja (vażodilataturi u li jaħdmu fuq is-sistema ċentrali), adrenergic neurone blockers, imblokkaturi tal-kanal tal-kalċju u imblokkaturi alpha-adrenoceptor, ma wrew ebda differenza fil-profil ta' effetti f'pazjenti li ħadu sildenafil mqabblin ma' kura bil-plaċebo.
English: Vizarsin 25 mg film-coated tablets Each film-coated tablet contains 1.9 mg lactose (as monohydrate).
Maltese: Vizarsin 25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 1.9 mg lactose (bħala monohydrate).
English: Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Maltese: Studji bi plejtlets umani jindikaw li sildenafil isahhaħ l-effett kontra l-aggregazzjoni ta' sodium nitroprusside in vitro.
English: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
Maltese: Inibituri ta' CYP3A4 aktar b'sahhithom bħal ketoconazole u itraconazole jkunu mistennija li jkollhom effetti akbar.
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta' difetti fil-vista relatati mal-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju (ara sezzjoni 4.8).
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Maltese: Is-sigurtà ta' sildenafil ma ġietx studjata f dawn is-sottogruppi ta' pazjenti li ġejjin, u għalhekk l-użu tiegħu huwa kontraindikat: indeboliment sever tal-fwied, pressjoni baxxa (pressjoni tad-demm <90/50 mmHg), passat reċenti ta' puplesija jew attakk tal-qalb u mard magħruf ereditarju ta' degenerazzjoni tar-retina bħal retinitis pigmentosa (minoranza ta' dawn il-pazjenti għandhom mard genetiku ta' phosphodiesterases retinali).
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Maltese: Prova ta' stress waqt l-eżerċizzju, double-blind, ikkontrollata bi plaċebo, evalwat 144 pazjent b'disfunzjoni erettili u anġina stabbli kronika li regolarment irċivew prodotti mediċinali kontra lanġina (ħlief nitrates).
English: Vizarsin will only help you to get an erection if you are sexually stimulated.
Maltese: Vizarsin jgħinek biss biex ikollok erezzjoni jekk inti tkun stimulat sesswalment.
English: In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.)
Maltese: F'voluntiera rġiel b'saħħithom, sildenafil fi stat fiss (80 mg t.i.d.) irriżulta f'żieda ta' 49.
English: These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
Maltese: Dan it-tnaqqis fil-pressjoni tad-demm huwa konsistenti mal-effetti ta' vażodilatazzjoni ta' sildenafil, probabilment minħabba żieda fil-livelli ta' cGMP fil-muskoli melliesa vaskulari.
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE03.
Maltese: Kodiċi ATC: G04BE03.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problem ereditarji rari ta' intolleranza ta' fruttozju m'għandhomx jieħdu din il-mediċina.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji għal intolleranza ta' galactose, iddefiċjenza ta' Lapp lactose jew bi problemi fl-assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Maltese: Wara doża orali ta' sildenafil l-AUC u Cmax jizdiedu fi proporzjon mad-doża fuq il-medda rakkomandata tad-doża (25-100 mg).
English: Drinking alcohol can temporarily impair your ability to get an erection.
Maltese: Ix-xorb alkoħoliku jista' temporanjament ifixkel l-abilità li jkollok erezzjoni.
English: In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo.
Maltese: Fi studji b'doża fissa, il-proporzjon ta' pazjenti li rrappurtaw li l-kura tejbet l-erezzjonijiet tagħhom kienu 62 % (25 mg), 74 % (50 mg), u 82 % (100 mg) mqabbla ma' 25 % tal-plaċebo.
English: for 1 tablet per blister:
Maltese: 1 fiha pillola miksija:
English: 1 orodispersible tablet 2 x 1 orodispersible tablet 4 x 1 orodispersible tablet 8 x 1 orodispersible tablet 12 x 1 orodispersible tablet
Maltese: 1 pillola miksija b'rita 4 x 1 pilloli miksija b'rita 8 x 1 pilloli miksija b'rita 12 x 1 pillola miksija b'rita
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Maltese: F'voluntiera b'indeboliment ħafif għal moderat tal-kliewi (tneħħija ta' kreatinina = 30-80 ml/min), il-farmakokinetiċi ta' sildenafil ma tbiddlux wara doża orali waħda ta' 50 mg.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively.
Maltese: Barra minn dan, il-valuri tal-AUC u Cmax tal-metabolit N-desmethyl żdiedu b'mod sinifikanti b' 200 % u 79 % rispettivament.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Maltese: Meta doża waħda ta' 100 mg sildenafil ġiet amministrata ma' erythromycin, inibitur ta' CYP3A4 moderat, fi stat stabbli (500 mg darbtejn kuljum għal 5 ijiem), kien hemm żieda ta' 182 % fl-espożizzjoni sistemika (AUC) ta' sildenafil.
English: Rare (may affect up to 1 in 1000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Maltese: Rari (jistgħu jaffettwaw sa 1 persuna minn kull 1,000): ħass ħażin, puplesija, attakk tal-qalb, taħbit irregolari tal-qalb, fluss tad-demm temporanjament imnaqqas għal partijiet tal-moħħ, sensazzjoni ta' ssikkar tal-gerżuma, telf ta' sensazzjoni fil-ħalq, fsada fuq wara tal-għajnejn, tara doppju, tnaqqis filpreċiżjoni viżiva, sensazzjoni mhux normali fl-għajnejn, nefħa tal-għajn jew tal-kappell tal-għajn, telf ta' kulur tal-abjad tal-għajnejn, fsada fil-pene, preżenza ta' demm fis-semen, imnieħer xott, nefħa fuq ġewwa tal-imnieħer, tħossok irritabbli u telf f'daqqa tas-smigħ.
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Maltese: F'voluntiera b'ċirrożi ħafifa għal moderata tal-fwied (Child-Pugh A u B) it-tneħħija ta' sildenafil tnaqqas, u rriżulta f żidiet fl-AUC (84 %) u Cmax (47 %) mqabbel ma' voluntiera tal-istess età li ma kellhomx ħsara fil-fwied.
English: jçJ
Maltese: Kft.
English: KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80
Maltese: KERN PHARMA, S.L. Tel: + 34 93 700 25 25
English: BLISTER for trilingual packaging
Maltese: FOLJA għal ippakjar trilingwali
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Maltese: Kien hemm differenzi ħfief u għaddiena fid-diskriminazzjoni tal-kulur (blu/aħdar) f'xi pazjenti li użaw il-Farnsworth-Munsell 100-Hue Test, siegħa wara li ħadu doża ta' 100 mg, u ebda effett ma deher sagħtejn wara d-doża.
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Maltese: L-għoti wkoll tal-inibitur ta' HIV protease saquinavir, inibitur ta' CYP3A4, fi stat stabbli (1200 mg tlett darbiet kuljum) ma' sildenafil (100 mg doża waħda) irrizulta f żieda ta' 140 % fis-Cmax ta' sildenafil u żieda ta' 210 % fl-AUC ta' sildenafil.
English: In volunteers with severe renal impairment (creatinine clearance <30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Maltese: F'voluntiera b'indeboliment sever tal-kliewi (tneħħija ta' kreatinina < 30ml/min), it-tneħħija ta' sildenafil naqset, u wasslet għal żidiet medji ta'l-AUC u Cmax ta' 100% u 88% rispettivament meta mqabbla ma' voluntiera tal-istess età li ma kellhomx ħsara fil-kliewi.
English: I!
Maltese: I! I
English: Vizarsin 100 mg orodispersible tablets Sildenafil
Maltese: Vizarsin 100 mg pilloli miksija b'rita Sildenafil
English: Effects of sildenafil on other medicinal products
Maltese: Effetti ta' sildenafil fuq prodotti mediċinali oħra
English: Vizarsin 100 mg film-coated tablets: White, oblong tablets, marked “100” on one side.
Maltese: Pilloli bojod, oblong, immarkati “100” fuq naħa waħda.
English: Penile haemorrhage, Priapism
Maltese: Pressjoni għolja, pressjoni baxxa
English: 1 orodispersible tablet 2 x 1 orodispersible tablet 4 x 1 orodispersible tablet 8 x 1 orodispersible tablet 12 x 1 orodispersible tablet 24 x 1 orodispersible tablet
Maltese: Pillola 1 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 12 x 1 pillola li jinallu fil-ħalq 24 x 1 pillola li jinallu fil-ħalq
English: Each orodispersible tablet contains 50 mg sildenafil.
Maltese: Kull pillola li tinħall fil-ħalq fiha fiha 50 mg sildenafil.
English: BEND AND TEAR PEEL
Maltese: OĦRA, JEKK MEĦTIEĠA
English: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 25 mg sildenafil.
English: Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma,
Maltese: Aċċident ċerebrovaskulari, Attakk iskemiku temporanju, Attakk ta' puplesija,* Attakki ripetuti ta' puplesija,* Sinkope
English: Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect, Diplopia,
Maltese: * Emorraġija retinali, Retinopatija arterjosklerotika, Disturb retinali, Glawkoma, Difett fil-kamp viżiv, Diplopja, Preċiżjoni viżiva mnaqqsa, Mijopija, Astenopja, Frak f'wiċċ il-likwidu vitruż, Disturb fil-ħabba tal-għajn,
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati minn fost il-pazjenti li użaw sildenafil flistudji klinici kienu uġigħ ta' ras, fwawar, dispepsja, sadd fl-imnifsejn, sturdament, dardir, fwawar sħan, disturb viziv, ċjanopsija u vista mċajpra.
English: Each film-coated tablet contains sildenafil citrate equivalent to 100 mg sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 100 mg sildenafil.
English: Vizarsin 50 mg film-coated tablets: White, oblong tablets, marked “50” on one side.
Maltese: Pilloli bojod, oblong, immarkati “50” fuq naħa waħda.
English: España KERN PHARMA, S.L.
Maltese: KRKA Pharma Dublin, Ltd.
English: The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
Maltese: Il-bidla korrispondenti fil-pressjoni dijastolika f'pożizzjoni minduda kienet 5.5 mmHg.
English: Asthenopia, Vitreous floaters,
Maltese: Emorraġija fil-pene, Prijapiżmu,
English: The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Maltese: Il-mekkaniżmu fiżjoloġiku responsabbli biex il-pene jibbies jinvolvi it-tnixxija ta' nitric oxide (NO) fil-corpus cavernosum waqt stimulazzjoni sesswali.
English: Vizarsin orodispersible tablets are available in boxes of 1 orodispersible tablet in blisters and also in boxes of 2 x 1, 4 x 1, 8 x 1, 12 x 1 or 24 x 1 orodispersible tablet in a perforated unit dose blisters.
Maltese: Pilloli li jinħallu fil-ħalq ta' Vizarsin huma disponibbli f'kaxxi ta' pillola 1 li tinħall fil-ħalq f'folji u wkoll f'kaxxi ta' 2 x 1, 4 x 1, 8 x 1, 12 x 1 jew 24 x 1 pillola li tinħall fil-ħalq f' folji perforati ta' doża unika.
English: Renal impairment:
Maltese: Riociguat:
English: 1 film-coated tablet: EU/1/09/551/009
Maltese: EU/1/09/551/009
English: Vizarsin 25 mg orodispersible tablets Sildenafil
Maltese: Vizarsin 25 mg pilloli miksija b'rita Sildenafil
English: Vizarsin 50 mg orodispersible tablets Sildenafil
Maltese: Vizarsin 50 mg pilloli miksija b'rita Sildenafil
English: Non-arteritic anterior ischaemic optic neuropathy (NAION)
Maltese: Newropatija anterjuri iskimika, mhux tal-arterja tal-għajn (NAION),
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 ml/min) a 25 mg dose should be considered.
Maltese: Peress li t-tneħħija ta' sildenafil titnaqqas f'pazjenti b'indeboliment sever tal-kliewi (tneħħija ta' kreatinina <30 ml/min) doża ta' 25 mg għandha tiġi kkunsidrata.
English: - If you have a deformity of your penis or Peyronie's Disease.
Maltese: - Jekk għandek deformità fil-pene tiegħek, jew il-marda ta' Peyronie.
English: In order for Vizarsin to be effective, sexual stimulation is required.
Maltese: Biex Vizarsin ikun effettiv, ikun hemm bżonn ta' stimulazzjoni sesswali.
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Maltese: Il-mekkaniżmu maħsub għal din il-bidla fid-diskriminazzjoni tal-kulur jinvolvi l-inibizzjoni ta' PDE6, li huwa involut fil-phototransduction cascade tar-retina.
English: Each film-coated tablet contains sildenafil citrate equivalent to 50 mg sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 50 mg sildenafil.
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment.
Maltese: Il-medja tal-AUC u Cmax tal-metabolit N-desmethyl żdiedu b'sa 126 % u b'sa 73 % rispettivament, meta mqabbla ma'
English: 'I'
Maltese: i'cI
English: Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years.
Maltese: Reazzjonijiet avversi minn sorvelljanza ta' wara t-tqegħid fis-suq ġiet miġbura fuq medda ta' >10 snin.
English: Doses above 100 mg do not increase the efficacy.
Maltese: Dozi ta' aktar minn 100 mg ma jżidux l-effikaċja.
English: The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Maltese: Wara li jittieħed jew mill-ħalq jew minn ġol-vina, sildenafil jiġi eliminat bħala metaboliti prinċipalment mal-ippurgar (madwar 80 % tad-doża orali) u f'proporzjon inqas fl-urina (madwar 13 % tad-doża orali).
English: Eyelid oedema, Scleral discoloration
Maltese: Fwawar, Fwawar talmenopawsa
English: Vizarsin 25 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Maltese: Visarsin pilloli ta' 25 mg miksija b'rita huma disponibbli f'kaxxi ta' pillola 1 miksija b'rita f'folji u wkoll f'kaxxi ta' 4 x 1, 8 x 1 jew 12 x 1 pillola miksija b'rita f'folji perforati ta' doża unika.
English: 1 film-coated tablet: EU/1/09/551/005
Maltese: EU/1/09/551/005
English: Transient ischaemic attack, Seizure Seizure recurrence Syncope
Maltese: Aktar tagħrif dwar provi kliniċi
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Maltese: Komuni (jistgħu jaffettwaw sa persuna minn kull 10): dardir, ħmura fil-wiċċ, fwawar tal-menopawsa (sintomi jinkludu sensazzjoni f'daqqa ta' sħana fil-parti ta' fuq tal-ġisem), ħmura fil-wiċċ, indiġestjoni, vista mżewwqa b'xi kulur, vista mċajpra, disturb viżiv, imnifsejn miżduda u sturdament.
English: Each orodispersible tablet contains 25 mg sildenafil.
Maltese: Kull pillola li tinħall fil-ħalq fiha 25 mg sildenafil.
English: Vizarsin 50 mg, 100 mg orodispersible tablets 3 years
Maltese: Vizarsin 50 mg, 100 mg pilloli li jinħallu fil-ħalq 3 snin
English: Vizarsin 25 mg film-coated tablets Sildenafil
Maltese: Vizarsin 25 mg pilloli li jinħallu fil-ħalq Sildenafil
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people)
Maltese: - Erezzjonijiet prolongati u kultant bl-uġieħ - dawn iseħħu b'mod rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: Iris disorder, Mydriasis, Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia Eye irritation, Abnormal sensation in eye,
Maltese: Dożi sa 200 mg ma rriżultawx f'żieda fl-effikaċja, imma l-inċidenza ta' reazzjonijiet avversi (uġigħ ta' ras, ħmura, sturdament, dispepsja, konġestjoni nażali, vista mibdula) kienet ogħla.
English: Lacrimation disorders***, Eye pain, Photophobia, Photopsia, Ocular hyperaemia, Visual brightness, Conjunctivitis
Maltese: Uġigħ fl-għajnejn, Fotofobija, Fotopsja,
English: U1I I
Maltese: j&yJ
English: Vizarsin 100 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Maltese: Visarsin pilloli ta' 100 mg miksija b'rita huma disponibbli f'kaxxi ta' pillola 1 miksija b'rita f'folji u wkoll f'kaxxi ta' 4 x 1, 8 x 1 jew 12 x 1 pillola miksija b'rita f'folji perforati ta' doża unika.
English: Each orodispersible tablet contains 100 mg sildenafil.
Maltese: Kull pillola li tinħall fil-ħalq fiha fiha 100 mg sildenafil.
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'sahhithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li irrizulta f'madwar 90% konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u l-metabolit attiv N-desmethly meta mqabbel ma' dawk li nstabu f'voluntiera żgħażagħ b'sahhithom (18-45 sena).
English: Vertigo, Tinnitus
Maltese: Vizarsin fih lattosju
English: Vizarsin 50 mg film-coated tablets are available in boxes of 1 film-coated tablet in blisters and also in boxes of 4 x 1, 8 x 1 or 12 x 1 film-coated tablet in a perforated unit dose blisters.
Maltese: Visarsin pilloli ta' 50 mg miksija b'rita huma disponibbli f'kaxxi ta' pillola 1 miksija b'rita f'folji u wkoll f'kaxxi ta' 4 x 1, 8 x 1 jew 12 x 1 pillola miksija b'rita f'folji perforati ta' doża unika.
English: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Maltese: Skont l-effikaċja u tollerabilità, id-doża tista' tiżdied f'inkrementi għal 50 mg sa 100 mg skont il-ħtieġa.
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Maltese: - Jekk inti għandek ċertu mard rari ereditarju tal-għajnejn (bħal retinitis pigmentosa).
English: With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Maltese: Bl-eċċessjoni ta' ritonavir li mhux rakkomandat li sildenafil jingħata miegħu (ara sezzjoni 4.4) doża tal-bidu ta' 25 mg għandha tiġi kunsidrata f pazjenti li fl-istess hin ikunu fuq trattament ta' inibituri ta' CYP3A4
English: Visual acuity reduced,
Maltese: Effetti sekondarji possibbli 5.
English: 1 film-coated tablet: EU/1/09/551/001
Maltese: EU/1/09/551/001
English: Agents for the treatment of erectile dysfunction, including sildenafil, 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: Sustanzi għal kura ta' problema tal-erezzjoni fosthom sildenafil, għandhom jintużaw b'kawtela f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrosi fil-korpus kavernożum jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas-sickle cell, majeloma multipla jew lewkimja).
English: The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Maltese: It-tnaqqis korrispondenti fil-pressjoni dijastolika tad-demm f pożizzjoni minduda kienet 7 mmHg.
English: Renal insufficiency:
Maltese: Indeboliment tal-kliewi:
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ml, compared to approximately 5 ng/ml when sildenafil was administered alone.
Maltese: F'24 siegħa, il-livelli ta' sildenafil fil-plażma kienu għadhom bejn wieħed u ieħor 200 ng/ml, imqabblin ma' bejn wieħed u ieħor 5 ng/ml meta sildenafil ingħata waħdu.
English: Vizarsin 100 mg film-coated tablets Sildenafil
Maltese: Vizarsin 100 mg pilloli li jinħallu fil-ħalq Sildenafil
English: When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Maltese: Meta sildenafil u doxazocine ngħataw fl-istess ħin lil pazjenti stabilizzati fuq kura ta' doxazocin kien hemm rapporti mhux spissi ta' pazjenti li kellhom pressjoni baxxa posturali sintomatika.
English: The recommended starting dose is 50 mg.
Maltese: Id-doża tal-bidu rrakkomandata hija 50 mg.