FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analysis of pulmonary arterial hypertension clinical trial data indicated a reduction in sildenafil clearance and/or an increase of oral bioavailability when co-administered with CYP3A4 substrates and the combination of CYP3A4 substrates and beta-blockers.
Maltese: Analiżi tal-farmakokinetiċi tal-popolazzjoni minn tagħrif ta' prova klinika fuq il-pressjoni għolja arterjali fil-pulmun indikat tnaqqis fit-tneħħija ta' sildenafil u/jew żieda fil-biodisponibilità orali meta jiġu ko-amministrati ma' substrat ta' CYP3A4 u meta jiġu kkumbinati substrati ta' CYP3A4 u betablockers.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96 %, 91 % and 82 %, respectively.
Maltese: F'din il-popolazzjoni, estimi Kaplan-Meier ta' 1, 2 u 3 snin ta' sopravvivenza kienu 96 %, 91 % u 82 %, rispettivament.
English: Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Maltese: Pazjenti bi frazzjoni ta' ejection tal-ventrikola taxxellug <45 % jew bi frazzjoni ta' tnaqqis fil-ventrikola tax-xellug <0.2 ma ġewx studjati.
English: Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63 % decrease of sildenafil AUC.
Maltese: L-għoti fl-istess ħin ta' bosentan (induttur moderat ta' CYP3A4, CYP2C9 u possibbilment ta' CYP2C19) 125 mg darbtejn kuljum ma' sildenafil 80 mg tlett darbiet kuljum (fi stat fiss) mogħtija flimkien għal 6 ijiem f'voluntiera b'saħħithom irriżulta fi tnaqqis ta' 63 % fl-AUC ta' sildenafil.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92 %, 81 % and 74 %, respectively.
Maltese: F'din il-popolazzjoni, estimi Kaplan-Meier ta' 1, 2 u 3 snin ta' sopravvivenza kienu 92 %, 81 % u 74 %, rispettivament.
English: PVC/Aluminium blisters of 90 tablets.
Maltese: Folji tal-PVC/Aluminju ta' 90 pillola Daqs tal-pakkett huwa ta' kartuna li fiha 90 pillola.
English: Write the date of expiry of the constituted oral suspension on the bottle label (the date of expiry of the constituted oral suspension is 30 days from the date of constitution).
Maltese: Ikteb id-data ta' skadenza tas-suspensjoni orali rikostitwita fuq it-tikketta tal-flixkun (id-data ta' skadenza tas-suspensjoni oral mħallta hija ta' 30 ġurnata mid-data ta' rikostituzzjoni).
English: Combined dose groups (n=77)
Maltese: Gruppi li qed jirċievu dożi kkombinati (n=77)
English: Revatio is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Maltese: Revatio jintuża fl-adulti, tfal u adoloxxenti ta' età ta' bejn sena u 17-il sena għat-trattament ta' pressjoni arterjali pulmonari għolja (pressjoni għolja fil-kanali tad-demm fil-pulmun).
English: Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted in the study, and neither was arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors.
Maltese: L-użu ta' prostacyclin, analogi ta' prostacyclin u antagonisti tar-riċettur ta' endothelin ma kienx permess waqt l-istudju, kif ukoll l-użu ta' supplimenti ta' arginine, nitrates, alpha-blockers u inibituri b'saħħithom ta' CYP450 3A4.
English: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Maltese: L-użu ta' prostacyclin, prostacyclin analogues u endothelin receptor antagonists ma kienx permess bħala terapija miżjuda, u lanqas suppliment ta' arginine.
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni saru biss f'adulti.
English: Do not take Revatio:
Maltese: Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Chemical and physical compatibility has been demonstrated with the following diluents:
Maltese: Kompatibilità kimika u fiżika ġiet murija mid-dilwenti li ġejjin:
English: The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
Maltese: Is-suspensjoni orali għandha titħawwad sew għal mhux inqas minn 10 seconds qabel tintuża.
English: PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta'PDE5, bħal Revatio, iżidu l-effetti ipotensivi ta' din il-mediċina.
English: Mean pulmonary systolic blood pressure decreased by 9 %.
Maltese: Il-pressjoni medja tad-demm sistolika tal-pulmun naqset b'9 %.
English: Similarly 191 of 229 subjects (83 %) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Maltese: Bl-istess mod, 191 minn 229 suġġett (83%) li kienu rċevew sildenafil baqgħu fl-istess jew tejbu il-Klassi Funzjonali tal-WHO tagħhom fl-evalwazzjoni tal-ewwel sena.
English: Most subjects were WHO Functional Class I (75/234, 32 %) or II (120/234, 51 %) at baseline; fewer patients were Class III (35/234, 15 %) or IV (1/234, 0.4 %); for a few patients (3/234, 1.3 %), the WHO Functional Class was unknown.
Maltese: III (35/234, 15 %) jew IV (1/234, 0.4 %); għal xi ftit pazjenti (3/234, 1.3 %), il-Klassi Funzjonali tal-WHO ma kienitx magħrufa.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini : http://www.ema.europa.eu.
English: The consequences of the subsequent lower exposure to the active Ndesmethyl metabolite observed after repeated IV administration of Revatio have not been documented.
Maltese: Il-konsekwenzi ta' livell inqas ta' esposizzjoni tal-metabolit attiv Ndesmethyl osservat wara amministrazzjoni repetuta ta' Revatio fil-vina ma ġewx dokumentati.
English: Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Maltese: Revatio soluzzjoni għall-injezzjoni hija formulazzjoni ta' Revatio alternattiva għal dawk il-pazjenti li temporanjament ma jistgħux jieħdu il-pilloli ta' Revatio.
English: Co-administration of oral contraceptives (ethinyloestradiol 30 g and levonorgestrel 150 g) did not affect the pharmacokinetics of sildenafil.
Maltese: L-għoti fl-istess ħin ta' kontraċettivi orali (ethinyloestradiol 30 g u levonorgestrel 150 g) m'affettwax il-farmakokinetiċi ta' sildenafil.
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72 % those of sildenafil after 20 mg three times a day oral dosing (translating into a 36 % contribution to sildenafil's pharmacological effects).
Maltese: F'pazjenti bi pressjoni arterjali pulmonari għolja, il-konċenetrazzjonijiet fil-plażma tal-metabolu N-desmethyl huma bejn wieħed u ieħor 72 % ta' dawk ta' sildenafil wara 20 mg tlett darbiet kuljum (li ssarraf f'kontribuzzjoni ta' 36 % għall-effetti farmakoloġiċi ta' sildenafil).
English: - Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
Maltese: • Informazzjoni dwar il-Programm ta' Monitoraġġ ta' Farmakoviġilanza relatat mar-riskju potenzjali ta' pressjoni baxxa klinikament relevanti, u problemi relatati magħha, li ser jkun mniedi bl-użu tad-DCF.
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Maltese: Disturbi fl-għajnejn Komuni emorroġija retinali, , tnaqqis fil-vista, vista mċajpra, fotofobija, kromatopsja, sijanopsja, irritazzjoni fl-għajnejn, iperimija fl-għajnejn
English: Mean baseline peak volume of oxygen consumed (VO2) values were comparable across the sildenafil treatment groups (17.37 to 18.03 ml/kg/min), and slightly higher for the placebo treatment group (20.02 ml/kg/min).
Maltese: Il-valuri ta' l-ogħla volum tal-ossiġenu ikkunsmat mil-linja bażi medja (VO2) kienu komparabbli mal-gruppi trattati b'sildenafil (17.37-18.03/kg mL/min), u ftit aktar għoljin fil-grupp trattat bil-plaċebo (20.
English: Do not use this medicine after the expiry date which is stated on the bottle after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-pakkett wara ‘EXP'.
English: The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Maltese: It-teħid flimkien ta' inibituri ta' PDE5, inkluż sildenafil, ma' stimulaturi ta' guanylate cyclase, bħal riociguat, huwa kontraindikat għax hemm il-possibbiltà li dan iwassal għal ipotensjoni sintomatika (ara sezzjoni 4.5).
English: A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1).
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' dejta b'sildenafil minn pazjenti adulti b'PAH fi provi kliniċi li kienu jinkludu studju ta' 12-il ġimgħa biex tiġi evalwata l-effikaċja u s-sigurtà ta' sildenafil 20 mg orali tliet darbiet kuljum meta miżjud ma' doża stabbli ta' bosentan (62.5 mg - 125 mg darbtejn kuljum), indikat tnaqqis fl-esponiment għal sildenafil meta mogħti flimkien ma' bosentan, bħal dak osservat f'voluntiera b'saħħithom (ara sezzjonijiet 4.4 u 5.1).
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 gravi tal-kliewi (tneħħija tal-kreatinina <30 ml/min), il-tneħħija ta' sildenafil naqas, b'riżultat ta' żidiet medji fil-valuri ta' AUC u Cmax ta' 100 % u 88 % rispettivament meta mqabbla ma' voluntiera ta' l-istess età mingħajr indeboliment renali.
English: Each ml of solution contains 0.8 mg of sildenafil (as citrate).
Maltese: Kull ml tas-soluzzjoni fiha 0.8 mg ta' sildenafil (bħala citrate).
English: Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension (PAH) who were already receiving and stable on oral Revatio 20 mg three times per day.
Maltese: A1481262 kien studju open-label ta' ċentru uniku, b'doża waħda, sabiex tkun valutata s-sigurta', tolerabilita' u farmakokinetika ta' doża waħdanija fil-vina ta' sildenaful (10 mg), mogħtija mill-vina f'forma ta' injezzjoni ‘bolus' lill-pazjenti bi Pressjoni Arterjali Għolja fil-Pulmun (PAH) li qed jirċievu diġa, u huma stabbli fuq Revatio 20 mg tlett darbiet kuljum.
English: The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2 % compared to 10.7 % in the placebo/epoprostenol treated patients.
Maltese: Ilfrekwenza totali ta' waqfien f'pazjenti trattati b'sildenafil/epoprostenol minħabba effetti avversi kienet ta' 5.2 % meta mqabbla ma' 10.
English: Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Maltese: Effetti sekondarki rrappurtati fi studju kliniku b'Revatio fil-vina kienu simili għal dawk irrappurtati fi studji kliniċi bil-pilloli Revatio.
English: Once reconstituted one bottle contains 1.12 g of sildenafil (as citrate) with a final volume of 112 ml.
Maltese: Ladarba rikostitwit flixkun wieħed fih 1.12 g ta' sildenafil (bħala citrate) b'volum finali ta' 112 ml.
English: In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Maltese: F'każ ta'deterjorament kliniku minkejja trattament b'Revatio, għandhom jiġu kkunsidrati terapiji alternattivi.
English: Revatio powder for oral suspension is for oral use only.
Maltese: Revatio trab għal suspensjoni orali huwa għal użu orali biss.
English: The mean changes from baseline in sitting blood pressure were greatest at 1 hour, -9.1 mmHg (SD ± 12.5) and -3.0 (SD ± 4.9) mmHg for systolic and diastolic pressure respectively.
Maltese: Ilbdil medju mill-linja bażi ta' pressjoni tad-demm bilqiegħda kienet l-akbar wara siegħa, -9.1 mmHg (SD ± 12.5) u -3.0 (SD ± 4.9) mmHg għall-pressjoni sistolika u dijastolika rispettivament.
English: A greater percentage of patients on each of the sildenafil doses (i.e. 28 %, 36 % and 42 % of subjects who received sildenafil 20 mg, 40 mg and 80 mg TID doses, respectively) showed an improvement by at least one WHO functional class at week 12 compared to placebo (7 %).
Maltese: Perċentwali akbar ta' pazjenti fuq kull doża ta' sildenafil (i.e. 28 %, 36 % u 42 % tas-suġġetti li rċevew dożi ta' 20 mg, 40 mg u 80 mg TID ta' sildenafil, rispettivament) wrew titjib ta' mill-inqas klassi funzjonali tal-WHIO waħda fit-12-il ġimgħa meta mqabbel mal-plaċebo (7%).
English: The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 % CI: 2 % to 32 %) and 27 % (95 % CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Maltese: Il-gruppi li qed jirċievu doża medja u għolja ta' sildenafil wrew tnaqqis fil-PVRI meta mqabbla mal-plaċebo, ta' 18% (95 % CI: 2 % sa 32 %) u 27 % (95 % CI: 14 % sa 39 %), rispettivament; filwaqt li l-grupp li qed jirċievi doża baxxa ma wera l-ebda differenza sinifikanti meta mqabbel mal-plaċebo (differenza ta' 2 %).
English: The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18 % (95 %CI: 2 % to 32 %) and 27 % (95 %CI: 14 % to 39 %), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2 %).
Maltese: Il-gruppi li qed jirċievu doża medja u għolja ta' sildenafil wrew tnaqqis fil-PVRI meta mqabbla mal-plaċebo, ta' 18% (95 % CI: 2 % sa 32 %) u 27% (95 % CI: 14 % sa 39 %), rispettivament; filwaqt li l-grupp li qed jirċievi doża baxxa ma wera l-ebda differenza sinifikanti meta mqabbel mal-plaċebo (differenza ta' 2 %).
English: Reconstitution instructions:
Maltese: Istruzzjonijiet ta' rikostituzzjoni:
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Maltese: Barra minn hekk il-valuri ta' AUC u Cmax għall-metabolu N-desmethyl, żdiedu b'mod sinifikanti b' 200 % u 79 % rispettivament f'pazjenti b'indeboliment gravi meta mqabbla ma' suġġetti b'funzjoni renali normali.
English: The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95 %CI: -8.9, 1.9) and -7.3 mmHg (95 %CI: -12.4, -2.1), respectively; whilst the low dose group showed little difference from placebo (difference of 1.6 mmHg).
Maltese: Il-gruppi li qed jirċievu doża medja u għolja ta' sildenafil wrew bidliet fil-mPAP mil-linja bażi meta mqabbla mal-plaċebo, ta' -3.5 mmHg (95 % CI: -8.9, 1.9) u -7.3 mmHg (95 % CI: -12.4, -2.1), rispettivament; filwaqt li l-grupp li qed jirċievi doża baxxa wera ftit differenza meta mqabbel mal-plaċebo (differenza ta' 1.6 mmHg).
English: When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29 % however, the extent of absorption was not significantly affected (AUC decreased by 11 %).
Maltese: Meta sildenafil jittieħed ma' l-ikel, ir-rata ta' assorbiment titnaqqas b'dewmien medju fit-tmax ta' 60 minuta u tnaqqis medju fis-Cmax ta' 29 %, madankollu l-ammont ta' assorbiment ma ġiex affetwat b'mod sinifikanti (AUC mnaqqas bi 11 %).
English: For patients with a baseline 6MWD < 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Maltese: Għal pazjenti b'linja bażi ta' 6MWD < 325 m, titjib fl-effikaċja ġie osservat b'dożi aktar għoljin (titjib irranġat bil-plaċebo kien ta' 58 metru, 65 metru u 87 metru għal dożi ta' 20 mg, 40 mg u 80 mg TID, rispettivament).
English: Remove the cap (figure 6).
Maltese: Neħħi l-għatu (stampa 6).
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85 %) and Cmax (47 %) compared to age-matched volunteers with no hepatic impairment.
Maltese: F'voluntiera b'ċirożi ħafifa għal moderata tal-fwied ( Child-Pugh A u B) il-tneħħija ta sildenafil tnaqqas, u rriżulta f'żidiet fl-AUC (84 %) u Cmax (47 %) mqabbel ma' voluntiera ta' l-istess età li ma kellhomx ħsara fil-fwied.
English: The population pharmacokinetic analysis in pulmonary arterial hypertension patients receiving oral sildenafil suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Maltese: Analiżi tal-farmakokinetiċi tal-popolazzjoni f'pazjenti bi pressjoni għolja arterjali tal-pulmun issuġġerixxiet li l-ko-amministrazzjoni ta' beta blockers f'kumbinazzjoni ma' substrati ta' CYP3A4 tista' tirriżulta f'żieda addiżjonali fl-espożizzjoni ta' sildenafil meta mqabbla ma' amministrazzjoni ta' substrati ta' CYP3A4 waħidhom.
English: Add a total of 90 ml of water (3 x 30 ml) strictly following the package leaflet, ensuring the bottle is shaken vigorously after adding 60 ml and the remaining 30 ml.
Maltese: Żid total ta' 90 ml ta' ilma (3 x 30ml) li ssegwi b'mod strett il-fuljett ta' tagħrif, waqt li tiżgura li lflixkun jitħawwad b'mod vigoruż wara li zzid 60ml u t-30ml l-oħra.
English: Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Maltese: Sildenafil ma kellu l-ebda effett sinifikanti fuq l-espożizzjoni għal atorvastatin (żieda fl-AUC ta' 11 %), li jissuġġerixxi li sildenafil ma fihx effett klinikament relevanti fuq CYP3A4.
English: In a study of healthy volunteers oral sildenafil at steady state (80 mg three times a day) resulted in a 50 % increase in bosentan AUC (125 mg twice daily).
Maltese: Fi studju fuq voluntiera f'saħħithom sildenafil b'ammont stabbli (80 mg tlett darbiet kuljum) irriżulta f'żieda ta' 50 % fl-AUC ta' bosentan (125 mg darbtejn kuljum).
English: Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94 %, 93 % and 85 % in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94 % and 93 % for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Maltese: L-istimi tas-sopravivenza Kaplan-Meier fit-tielet sena fil-pazjenti bil-piż ta' > 20 kg fil-linja bażi kienu 94%, 93% u 85% fil-gruppi li qed jirċievu doża baxxa, medja u għolja, rispettivament; filpazjenti bil-piż ta' ≤ 20 kg fil-linja bażi, l-istimi ta' sopravvivenza tas-suġġetti fil-gruppi li qed jirċievu doża medja u għolja kienu 94% u 93% rispettivament (ara sezzjonijiet 4.4 u 4.8).
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99 %, 91 %, and 84 % respectively, and for patients of WHO functional class III at baseline was 94 %, 90 %, and 81 %, respectively.
Maltese: II tal-WHO fil-linja bażi fis-snin 1, 2 u 3 kienet ta' 99 %, 91 %, u 84 % rispettivament u għall pazjenti tal-Klassi Funzjonali
English: Batch
Maltese: FLIXKUN
English: Visual events
Maltese: Avvenamenti viżwali
English: One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
Maltese: Flixkun tal-ħġieġ ambra wieħed ta' 125ml (b'għatu tal-polyethylene bil-kamini biex jingħalaq) fih 32.27g ta' trab għal suspensjoni orali.
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: Ko-amministrazzjoni ta' l-inibitur ta' HIV protease ritonavir, li huwa inibitur potenti ħafna tal-P450, fi stat fiss (500 mg darbtejn kuljum) ma' sildenafil (100 mg doża waħda) irriżultat f'żieda ta' 300 % (4 darbiet) fis-Cmax ta' sildenafil u żieda ta' 1000 % (11-il darba) fl-AUC tal-plażma ta' sildenafil.
English: (p = 0.056)
Maltese: G04B E03
English: VIAL LABEL
Maltese: Azzjoni vażodilatatorja
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 doxazosin ġew amministrati flimkien lil pazjenti stabilizzati fuq doxazosin, kien hemm rapporti mhux frekwenti ta' pazjenti li esperjenzaw sintomi ta' pressjoni baxxa minħabba lpożizzjoni.
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 ta' l-effetti imodinamiċi ta' doża waħda orali ta' 100 mg sildenafil f'14-il pazjent b'mard sever ta' l-arterji tal-qalb (CAD) ( > 70 % stenożi f'ta mill-anqas arterja waħda tal-qalb), il-pressjoni medja tad-demm sistolika u dijastolika waqt is-serħan naqsu b' 7 % u 6 % rispettivament mqabbla mal-linja bażi.
English: SLOWLY push down the plunger of the oral dosing syringe.
Maltese: Imbotta l-planġer lura ġos-siringa.
English: Each 20 ml vial contains 12.5 ml (10 mg sildenafil, as citrate).
Maltese: Kull kunjett ta' 20 ml fih 12.5 ml ts' soluzzjoni (10 mg ta' sildenafil bħala citrate).
English: See section 6.6 for instructions of use.
Maltese: Ara sezzjoni 6.6 għall-istruzzjonijiet dwar l-użu.
English: This is based on Pharmacokinetic data only (see section 5.2.
Maltese: Din hija bbażata biss fuq dejta Farmakokinetika boss (ara sezzjoni 5.2 Tagħġrif Farmakokinetiku).
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with oral sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Maltese: Ko-amministrazzjoni ta' l-inibitur ta' HIV protease saquinavir, inibitur ta' CYP3A4, fi stat fiss (1200 mg tlett darbiet kuljum) ma' sildenafil (100 mg doża waħda) irriżultat f'żieda ta' 140 % fis-Cmax ta' sildenafil u żieda ta' 210 % fl-AUC ta' sildenafil.
English: You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).
Maltese: Dejjem għandek iżżid total ta' 90 ml (3 x 30 ml) ta' ilma irrispettivament mid-doża li qed tieħu (stampa 3).
English: No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable.
Maltese: Ma hemm l-ebda dejta klinika dwar amministrazzjoni ta' sildenafil IV f'pazjenti li huma klinikament jew emodinamikament instabbli.