FrancophonIA/ELRC3.0 huggingface dataset:
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Maltese: Fi tliet studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, alpha-blocker doxazocin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg u 100 mg) ġew amministrati fl-istess ħin lil pazjenti bi tkabbir benin tal-prostata (BPH), stabilizzati fuq kura b' doxazocin.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenia
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Maltese: Dan il-metabolit għandu profil selettiv ta' phosphodiesterase simili għal sildenafil u potenza in vitro għal PDE5 ta' madwar 50 % ta' dik tal-mediċina mhux mibdula.
English: Vizarsin 50 mg orodispersible tablets Each orodispersible tablet contains 0.75 mg aspartame (E951) and 0.0175 mg sorbitol (E420).
Maltese: Vizarsin 50 mg pilloli li jinħallu fil-ħalq Kull pillola li tinħall fil-ħalq fiha 0.75 mg aspartame (E951) u 0.0175 mg sorbitol (E420).
English: The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Maltese: Il-gruppi ta' pazjenti li ġejjin kienu rappreżentati: anzjani (19.9%), pazjenti bi pressjoni għolja (30.9%), dijabete mellitus (20.3%), mard iskemiku tal-qalb (5.8%), iperlipidemja (19.8%), korrimenti fl-ispina dorsali (0.6%), dipressjoni (5.2%), b'resezzjoni transuretrali tal-prostata (3.7%), u prostatektomija radikali (3.3%).
English: (E420)), crospovidone, calcium silicate and magnesium stearate (E572).
Maltese: crospovidone, calcium silicate u magnesium stearate (E572).
English: This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
Maltese: Dan jista' jsehh l-aktar sa 4 sigħat wara li tittieħed id-doża ta' sildenofil (ara sezzjonijiet 4.2 u 4.4).
English: 1 orodispersible tablet: EU/1/09/551/013 2 x 1 orodispersible tablet: EU/1/09/551/014 4 x 1 orodispersible tablet: EU/1/09/551/015 8 x 1 orodispersible tablet: EU/1/09/551/016 12 x 1 orodispersible tablet: EU/1/09/551/017
Maltese: EU/1/09/551/014 4 x 1 pillola li tinħall fil-ħalq EU/1/09/551/015 8 x 1 pillola li tinħall fil-ħalq EU/1/09/551/016 12 x 1 pillola li tinħall fil-ħalq EU/1/09/551/017
English: Each orodispersible tablet contains 0.375 mg aspartame (E951) and 0.00875 mg sorbitol (E420).
Maltese: Kull pillola li tinħall fil-ħalq fiha 0.375 mg aspartame (E951) u 0.00875 mg sorbitol (E420).
English: *, Myocardial infarction, Ventricular arrhythmia Atrial fibrillation, Unstable angina
Maltese: * Fibrillazzjoni atrijali, Anġina instabbli
English: In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Maltese: B'mod partikulari, sildenafil għandu selettività ta' aktar minn 4,000 darba għal PDE5 fuq PDE3, is-cAMP -specific phosphodiesterase isoform involut fil-kontroll tal-kontrattilità.
English: Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Maltese: Il-metaboliżmu ta' sildenafil isehh l-aktar permezz tal-iżoformi ta' ċitokromju P450 (CYP) 3A4 (rotta ewlenija) u 2C9 (rotta minuri).
English: Vizarsin 100 mg orodispersible tablets Each orodispersible tablet contains 1.5 mg aspartame (E951) and 0.035 mg sorbitol (E420).
Maltese: Vizarsin 100 mg pilloli li jinħallu fil-ħalq Kull pillola li tinħall fil-ħalq fiha 1.5 mg aspartame (E951) u 0.035 mg sorbitol (E420).
English: Vizarsin 25 mg film-coated tablets: White, oblong tablets, marked “25” on one side.
Maltese: Vizarsin 25 mg pilloli miksija b'rita: Pilloli bojod, oblong, immarkati “25” fuq naħa waħda.
English: Luxembourg/Luxemburg
Maltese: België/Belgique/Belgien
English: Vizarsin 25 mg orodispersible tablets Vizarsin 50 mg orodispersible tablets Vizarsin 100 mg orodispersible tablets
Maltese: Vizarsin 25 mg pilloli miksija b'rita Vizarsin 50 mg pilloli miksija b'rita Vizarsin 100 mg pilloli miksija b'rita
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Maltese: Hemm selettività ta' 10-darbiet għal PDE6 li huwa involut fil-passaġġ ta' phototransduction fir-retina.
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Maltese: Dożi waħdanin ta' antaċidu (magnesium hydroxide/aluminium hydroxide) ma effettwatx il-bijodisponiblità ta' sildenafil.
English: The dosing recommendations described in ‘Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min).
Maltese: Ir-rakkomandazzjonijiet ta' dożaggi mfissra f' “Użu fl-adulti” japplikaw għal pazjenti b'indeboliment ħafif għal moderat tal-kliewi (tneħħija ta' kreatinina = 30-80 ml/min).
English: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Maltese: Sildenafil huwa mnaddaf prinċipalment mill-iżoenzimi mikrożomali CYP3A4 (rotta ewlenija) u CYP2C9 (rotta minuri) tal-fwied.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Maltese: Għalkemm ma sarux studji speċifiċi ta' interazzjoni għal prodotti mediċinali kollha, analiżi farmakokinetiċi tal-popolazzjoni ma wrew l-ebda effett ta' medikazzjoni konkomitanti fuq il-farmakokinetiċi ta' sildenafil meta miġbura fi gruppi bħala inibituri ta' CYP2C9 (bħal tolbutamide, warfarin, phenytoin), inibituri ta' CYP2D6 (bħal selective serotonin reuptake inhibitors, antidipressanti triċikliċi), thiazide u dijuretiċi relatati, dijuretiċi loop u li jirristrinġu t-tnixxija ta' potassju, inibituri tal-enżima li tikkonverti l-angiotensin, imblokkaturi tal-kanal tal-kalċju, antagonisti beta-adrenoreceptor jew sensitizzaturi tal-metaboliżu CYP450 (bħal rifampicin, barbiturate).
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Maltese: Dan huwa konsistenti mal-effetti sinifikanti ta' ritonavir fuq varjetà wiesgħa ta' sustrati ta' P450.
English: (NAION).
Maltese: cimetidine).
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Maltese: Minħabba il-komponent ta' nitrate, hemm potenzjal ta' interazzjoni serja ma' sildenafil.
English: Headache Dizziness
Maltese: U ĊARRAT QAXXAR
English: Blister (perforated unit dose blister, PVC-foil/Alu-foil): 4 x 1, 8 x 1 or 12 x 1 film-coated tablet, in a carton.
Maltese: Folja (folja perforata ta' doża unika, fojl tal-PVC/fojl tal-Alu): 4 x 1, 8 x 1 jew 12 x 1 pillola miksija b'rita, f'kartuna.
English: PDE5 inhibitors, such as Vizarsin have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta'PDE5, bħal Vizarsin,iżidu l-effetti ipotensivi ta' din il-mediċina.
English: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Maltese: Fil-provi kollha, il-proporzjon ta' pazjenti li rrapurtaw titjib bil-sildenafil kienu kif ġejjin: problema ta' erezzjoni tal-pene psikoġeniika (84%), problemi tal-erezzjoni mħallta (77%), problema ta' erezzjoni organika (68%), anzjani (67%), dijabetiċi (59%), mard iskemiku tal-qalb (69%), pressjoni għolja (68%), TURP (61%), prostatektomija radikali (43%), korriment fl-ispina dorsali (83%), dipressjoni (75%).
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Maltese: Cimetidine (800 mg), inibitur ta' ċitokromju P450 u inibitur ta' CYP3A4 mhux speċifiku, wassal għal żieda ta' 56 % fil-konċentrazzjonijiet ta' sildenafil fil-plażma meta ngħata flimkien ma' sildenafil (50 mg) fuq voluntiera b'sahhithom.
English: In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Maltese: F'voluntiera b'saħħithom li ħadu sildenafil (100 mg doża waħda), anqas minn 0.0002 % (medja 188 ng) tad-doża amministrata kienet preżenti fl-isperma 90 minuta wara d-doża.
English: BLISTER for monolingual and bilingual packaging
Maltese: FOLJA għal ippakkjar monolingwali u bilingwali
English: CARTON for monolingual and bilingual packaging
Maltese: KARTUNA għal ippakkjar monolingwali u bilingwali
English: Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Maltese: Fil-provi kollha, il-proporzjon ta' pazjenti li rrapurtaw titjib bil-sildenafil kienu kif ġejjin: problema ta' erezzjoni tal-pene psikoġenetika (84 %), problemi tal-erezzjoni mħallta (77 %), problema ta' erezzjoni organika (68 %), anzjani (67 %), dijabetiċi (59 %), mard iskemiku tal-qalb (69 %), pressjoni għolja (68 %), TURP (61 %), prostatektomija radikali (43 %), korriment fl-ispina dorsali (83 %), dipressjoni (75 %).
English: Mean pulmonary systolic blood pressure decreased by 9%.
Maltese: Il-pressjoni medja tad-demm sistolika tal-pulmun naqset b'9%.
English: Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Maltese: Il-ko-amministrazzjoni ta' sildenafil ma' ritonavir mhix irrakkomandata (ara sezzjoni 4.5).
English: Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Maltese: Sildenafil ma kellux effett fuq il-farmakokinteċi ta' saquinavir (ara sezzjoni 4.2).
English: Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/ml (38 nM).
Maltese: Minħabba li sildenafil (u l-metabolit fiċċirkolazzjoni ewlenieni tiegħu N-desmethyl) huwa 96% marbut ma' proteini tal-plażma, dan irriżulta fl-ogħla konċentrazzjoni ta' plażma ħielsa għal sildenafil b'18 ng/ml (38nM).
English: The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues.
Maltese: Il-medja tal-volum ta' distribuzzjoni fi stat fiss (Vd) għal sildenafil huwa ta' 105 l, li jindika distribuzzjoni fit-tessut.
English: Paediatric population Vizarsin is not indicated for individuals below 18 years of age.
Maltese: Popolazzjoni pedjatrika Vizarsin mhux indikat għal individwi taħt l-età ta' 18 sena.
English: - Seizures or fits - this occurs rarely
Maltese: - Reazzjonijiet serji tal-ġilda- dawn iseħħu b'mod rari
English: In vitro studies: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4
Maltese: Sildenafil huwa inibitur dgħajjef ta' ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 (1C50 > 150 uM).
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Maltese: Nitric oxide mbagħad jattiva l-enzima guanylate cyclase, li tirriżulta f livelli miżjuda ta' cyclic guanosine monophosphate (cGMP), li tipproduċi rilassament fil-muskoli melliesa tal-corpus cavernosum u tikkawża d-dħul tad-demm.
English: Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Maltese: Sildenafil (50 mg) ma ħarrax iż-żieda fil-ħin ta' fsada kkaġunat mill-acetyl salicyclic acid (150 mg).
English: Vizarsin 50 mg film-coated tablets Each film-coated tablet contains 3.8 mg lactose (as monohydrate).
Maltese: Vizarsin 50 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 3.8 mg lactose (bħala monohydrate).
English: The major circulating metabolite results from N-demethylation of sildenafil.
Maltese: Il-metabolit ċirkulatorju ewlieni jirrizulta minn N-demethylation ta' sildenafil.
English: 1 orodispersible tablet: EU/1/09/551/023
Maltese: EU/1/09/551/023
English: Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, bloodshot eyes /red eyes, eye pain, seeing flashes of light, visual brightness, light sensitivity, watery eyes, pounding heartbeat, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy sinuses, inflammation of the lining of the nose (symptoms include runny nose, sneezing and stuffy nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), presence of blood in urine, pain in the arms or legs, nosebleed, feeling hot and feeling tired.
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100): rimettar, raxx, irritazzjoni fl-għajnejn, għajnejn ħomor, uġigħ fl-għajn, tara leħħiet ta' dawl bħal berqa, luminożità viżiva, sensittività għaddawl, għajnejn idemmgħu, taħbit qawwi tal-qalb, taħbit tal-qalb mgħaġġel, pressjoni għolja, pressjoni baxxa, uġigħ fil-muskoli, ngħas tqil, tnaqqis fis-sens tal-mess, vertigo, tisfir fil-widnejn, ħalq xott, imnifsejn imblukkati jew mimlijin, infjammazzjoni tar-rita tal-imnieħer (sintomi jinkludu tnixxija, għatis u sadda), uġigħ addominali fil-parti ta' fuq, mard tar-rifluss gastro-esofaġeali (sintomi jinkludu ħruq ta' stonku), preżenza ta' demm fl-awrina, uġigħ fid-dirgħajn u r-riġlejn, fsada fl-imnieħer, sensazzjoni ta' sħana u għeja.
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% 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' voluntiera tal-istess età li ma kellhomx ħsara fil-kliewi.
English: Deafness
Maltese: Riociguat
English: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Maltese: B'mod konsistenti mal-effetti magħrufa ta' sidenafil fuq il-passaġġ nitric oxide/cGMP (ara sezzjoni 5.1), intwera li sildenafil iħarrax l-effetti ta' nitrates li jnaqqsu l-pressjoni u għaldaqstant il-koamministrazzjoni ta' sildenafil u donaturi ta' nitric oxide jew nitrates hija kontraindikata (ara sezzjoni 4.3).
English: In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
Maltese: Fi studju tal-pene bil-plestismografu (RigiScan) f'pazjenti sajmin, il-hin medjan biex jibdew l-erezzjonijiet għal dawk li kisbu 60 % rigidità (suffiċjenti għal rapport sesswali) kien 25 minuta (medda bejn 12-37 minuta) b'sildenafil.
English: Vizarsin 100 mg film-coated tablets Each film-coated tablet contains 7.6 mg lactose (as monohydrate).
Maltese: Vizarsin 100 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 7.6 mg lactose (bħala monohydrate).
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 għat-trattament tal-ipertensjoni arterjali pulmonarja (i.e., pressjoni għolja tad-demm fil-pulmuni) u ipertensjoni pulmonarja tromboembolika kronika (i.e., pressjoni għolja tad-demm fil-pulmuni kkawżata minn ċapep fiddemm).
English: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Maltese: F'voluntiera rġiel normali b'sahhithom, ma kienx hemm evidenza ta' xi effett ta' azithromycin (500 mg kuljum għal 3 ijiem) fuq ir-rata tal-eliminazzjoni fissa tal-AUC, Cmax u tmax, jew il-half life ta' wara ta' sildenafil jew il-metabolit principali tiegħu fiċ-ċirkolazzjoni.
English: The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Maltese: L-ogħla tnaqqis medju fil-pressjoni sistolika f'pożizzjoni minduda wara 100 mg ta' doża orali ta' sildenafil kienet ta' 8.4 mmHg.
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi ta' importanza medika, li sehhew fl-istudji klinici b'inċidenza iktar milli bil-plaċebo, huma mnizzla skont il-klassi tal-organi u l-frekwenzi (komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Maltese: L-għoti wkoll tal-inibitur ta' HIV protease ritonavir, fi stat stabbli (500 mg darbtejn kuljum) ma' sildenafil (100 mg doża waħda) irriżulta f'żieda ta' 300 % (4 darbiet) fis-Cmax ta' sildenafil u żieda ta' 1,000 % (11-il darba) fl-AUC tal-plażma ta' sildenafil.
English: 1 orodispersible tablet: EU/1/09/551/018
Maltese: EU/1/09/551/018
English: Vizarsin contains aspartame (E951), a source of phenylalanine which may be harmful for people with phenylketonuria.
Maltese: Vizarsin fih aspartame (E951), sors ta' phenylalanine li jista' jkun ta' ħsara għal persuni b'fenilketonurja.
English: Myalgia, Pain in extremity
Maltese: Mijalġja, Uġigħ fl-estremitajiet
English: Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Maltese: Peress li mhux ir-reazzjonijiet avversi kollha huma rapportati lid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u inklużi fid-database tas-sigurtà, il-frekwenzi ta' dawn ir-reazzjonijiet ma jistgħux jiġu stabbiliti b'mod affidabbli.
English: Vizarsin 100 mg orodispersible tablets 1 orodispersible tablet: EU/1/09/551/023
Maltese: Vizarsin 100 mg pilloli li jinħallu fil-ħalq Pillola 1 li tinħall fil-ħalq EU/1/09/551/023
English: Each film-coated tablet contains sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg sildenafil.
Maltese: Kull pillola miksija b'rita fiha sildenafil citrate ekwivalenti għal 25 mg, 50 mg jew 100 mg sildenafil.
English: Each orodispersible tablet contains 25 mg, 50 mg or 100 mg sildenafil.
Maltese: Kull pillola li tinħall fil-ħalq fiha 25 mg, 50 mg jew 100 mg sildenafil.
English: Blister (peel open blister, Oriented Polyamide/Aluminium/PVC//PET/Aluminium): 1 orodispersible tablet, in a carton.
Maltese: Folja (folja li tqaxxarha miftuħa, Polyamide Orjentat/Aluminju/PVC//PET/Aluminju): pillola 1 li tinħall fil-ħalq, f'kartuna.
English: For 4 tablets per blister:
Maltese: 4 x 1 pillola miksija:
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Maltese: Fi studju żgħir bil-plaċebo bħala kontroll ta' pazjenti b'deġenerazzjoni makulari bikrija dokumentata relatata mal-età (n=9), sildenafil (doża waħda, 100 mg) ma wera ebda tibdil sinifikanti f'testijiet fuq il-vista li saru (kemm tkun akuta l-vista, Amsler grid, diskriminazzjoni ta' kulur ta' dwal tat-traffiku simulati, Humphrey perimeter u photostress).
English: Blister (PVC-foil/Alu-foil): 1 film-coated tablet, in a carton.
Maltese: Folja (fojl tal-PVC/fojl tal-Alu): pillola 1 miksija b'rita, f'kartuna.
English: Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Maltese: B'mod konsistenti mal-effetti magħrufa tiegħu fuq il-passaġġ ta' nitric oxide/cyclic guanosine monophosphate (cGMP) (ara sezzjoni 5.1), sildenafil intwera li jsaħħaħ l-effetti ipotensivi ta' nitrati, u l-amministrazzjoni konġunta b'donaturi ta' nitric oxide (bħal amyl nitrite) jew nitrati f'xi għamla oħra għalhekk kontraindikata.
English: Tear Peel
Maltese: Kuluri li
English: Retinal vascular occlusion
Maltese: Disturbi vaskulari
English: Sildenafil had no effect on ritonavir pharmacokinetics.
Maltese: Sildenafil ma kellux effett fuq il-farmakokinetiċi ta' ritonavir.
English: After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ml (CV 40%).
Maltese: Wara doża orali waħda ta' 100 mg, l-ogħla konċentrazzjoni medja totali ta' sildenafil fil-plażma kienet madwar 440 ng/ml (CV 40%).
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Maltese: Fi studju tal-effetti emodinamiċi ta' doża orali waħda ta' 100 mg sildenafil f'14-il pazjenti b'mard sever tal-arterji tal-qalb (CAD) (> 70 % stenożi f' ta' mill-anqas arterja waħda tal-qalb), il-pressjoni sistolika u dijastolika medja tad-demm waqt is-serħan naqset b'7 % u 6 % rispettivament meta mqabbla mal-linja bażi.
English: Vizarsin 50 mg film-coated tablets 1 film-coated tablet: EU/1/09/551/005
Maltese: Vizarsin 50 mg pilloli li jinħallu fil-ħalq Pillola 1 li tinħall fil-ħalq EU/1/09/551/018
English: You may experience an increase in side effects and their severity.
Maltese: Tista' tesperjenza zieda fl-effetti sekondarji u fis-severità tagħhom.
English: CARTON for trilingual packaging
Maltese: KARTUNA għal ippakjar trilingwali