FrancophonIA/ELRC3.0 huggingface dataset:
English: - Therapies for pulmonary hypertension (e.g. bosentan, iloprost) - Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy) - Blood thinning medicines (for example warfarin) although these did not result in any side effect.
Maltese: John's Wort (prodott erbali mediċinali), rifampicin (użat għal trattament ta' infezzjinijiet batteriċi), carbamazepine, phenytoin u phenobarbital (użat, fost oħrajn, għal trattament ta' epilessija) - Mediċini li jimpedixxu d-demm milli jagħqad (per eżempju warfarin) għalkemm meta mogħtija flimkien ma rriżulta fl-ebda effett sekondarju
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 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: Nervous system disorders Very common headache
Maltese: Disturbi fis-sistema nervuża
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: Sildenafil had no effect on saquinavir pharmacokinetics.
Maltese: Effetti ta' sildenafil fuq prodotti mediċinali oħra
English: Not known sudden hearing loss
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.
Maltese: Dan it-tnaqqis addizzjonali fil-pressjoni tad-demm kien ta' daqs simili għal dak li deher meta sindenafil ġie amministrat waħdu lil volunteera f'saħħithom.
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 moderat ta' CYP3A4 fi stat fiss (500 mg darbtejn kuljum għal 5 jiem), kien hemm żieda ta' 182 % fis-systemic exposure (AUC) ta' sildenafil.
English: Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87% of 183 patients on study treatment were receiving sildenafil 80 mg TID.
Maltese: Dożi sa 80 mg tlett darbiet kuljum (4 darbiet id-doża rakkomandata ta' 20 mg tlett darbiet kuljum) ġew amministrati u wara 3 snin, 87% minn 183 pazjent kienu qed jirċievu sildenafil 80 mg TID bħala trattament ta' waqt l-istudju.
English: The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues.
Maltese: Il-medja tal-volum ta' distribuzzjoni fiss (Vss) għal sildenafil huwa 105 l, li jindika distribuzzjoni fit- tessuti.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Din il-mediċina ma għandhiex tingħata lil pazjenti li għandhom problemi ereditarji ta' intolleranza għall-galactose, defiċjenza fil-Lapp lactase jew li għandhom problemi fl-assorbiment ta' glucose-galactose.
English: Due to the nitrate component it has the potential to have serious interaction with sildenafil (see section 4.3).
Maltese: Minħabba il-komponent ta' nitrate, hemm potenzjal ta' interazzjoni serja ma' sildenafil (ara sezzjoni 4.3).
English: Differences in 6MWD were observed between patients with primary PAH and PAH associated with connective tissue disease.
Maltese: Differenzi fis-6MWD ġew osservati bejn pazjenti b'PAH primarja u b'PAH assoċjata ma' mard tat- tessut konnettiv.
English: Long-term survival data in naive population
Maltese: Data ta'sopravvivenza fuq tul ta'żmien twil fil-popolazzjoni naive
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: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension.
Maltese: Trattament ta' pazjenti pedjatriċi ta' età ta' bejn sena u 17-il sena bi pressjoni għolja arterjali talpulmun.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Maltese: L-ogħla konċentrazzjonijiet ta' plażma osservati jintlaħqu fi żmien 30 għal 120 minuta (medjan 60 minuta) ta' doża orali fi stat sajjem.
English: Each tablet contains 20 mg of sildenafil (as citrate).
Maltese: Kull pillola fiha 20 mg ta' sildenafil (bħala citrate).
English: Adverse reactions which occurred in >1% of sildenafil-treated patients and were more frequent (>1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to ≤1/100) and not known (cannot be estimated from the available data).
Maltese: Tabella b'lista ta' reazzjonijiet avversi Reazzjonijiet avversi li ġraw f' > 1 % tal-pazjenti ttrattati b'sildenafil u li kienu iktar frekwenti (> 1 % differenza) b'sildenafil fl-istudju pivitali jew fis-sett ta' tagħrif ikkombinat ta' sildenafil, fiżżewġ studji kkontrollati bi plaċebo fuq pressjoni għolja arterjali tal-pulmun, f'dożi ta' 20, 40 jew 80 mg TID huma mniżżla fit-tabella hawn taħt f'sezzjonijiet ta' frekwenza (komuni ħafna (≥1/10), komuni(≥1/100 sa < 1/10), mhux komuni (≥1/1000 sa < 1/100) u mhux magħrufa (ma tistax tiġi stmata mit- tagħrif disponibbli).
English: Use of sildenafil with bosentan
Maltese: L-użu ta' sildenafil ma' bosentan
English: Driving and using machines
Maltese: Azzjoni vażodilatatorja
English: Breast-feeding
Maltese: Studjiinvivo
English: Of the total 229 subjects who received sildenafil, there were 55, 74, and 100 subjects in the low, medium and high dose groups, respectively.
Maltese: Mit-total ta' 229 suġġett li rċivew sildenafil, kien hemm 55, 74, u 100 suġġett fil-gruppi tad-doża baxxa, medja u għolja, rispettivament.
English: Subjects (38% male and 62% female) had a body weight ≥8 kg, and had primary pulmonary hypertension (PPH) [33%], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37%, surgical repair 30%].
Maltese: % rġiel u 62 % nisa) kellhom piż tal-ġisem ta' 8 kg, u kellhom pressjoni pulmonari primarja (PPH) [33%], jew PAH sekondarja għal mard tal-qalb mit-twelid [shunts sistemiċi-pulmonari 37 %, tiwija tal-kirurġija 30 %].
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: Cmax after a single 20 mg sildenafil dose administered PO was estimated at 49, 104 and 165 ng/ml for 70, 20 and 10 kg patients, respectively.
Maltese: Wara amministrazzjoni mill-ħalq ta' doża waħda ta' 20 mg sildenafil, Cmax kien ikkalkulat f'konċentrazzjoni ta' 49, 104 u 165ng ml għal pazjenti bil-piż ta' 70, 20 u 10 kg, rispettivament.
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 malplaċebo, 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: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on 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: Film coat:
Maltese: Kodiċi ATC:
English: A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone.
Maltese: Aġġustament ta' tnaqqis fid-doża għal 20mg darba kuljum hija rakkomandata f'każijiet ta' amministrazzjoni flimkien ma' inibituri ta' CYP3A4 aktar b'saħħithom bħal clarithromycin, telithromycin u nefazodone.
English: Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomized, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Maltese: Effikaċja u sigurtà f'pazjenti adulti b'PAH (meta użat flimkien ma' bosentan) Studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind u kkontrollat bil-plaċebo, twettaq f'103 pazjenti li kienu klinikament stabbli b'PAH (WHO FC II and III) li kienu fuq terapija b'bosentan għal minimu ta' tliet xhur.
English: A total of 234 subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.
Maltese: Total ta' 234 suġġett ta' età ta' bejn sena u 17-il sena kienu trattati fi studju b'mod każwali, doubleblind, multi-ċentriku, ikkontrollat fl-istess ħin bi grupp li ngħata l-plaċebo, u dożi varji.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain
Maltese: Laboratori Fundacio Dau C/ C, 12-14
English: In a study of healthy volunteers 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: Cmax after a single 10 mg sildenafil dose administered PO was estimated at 24, 53 and 85 ng/ml for 70, 20 and 10 kg patients, respectively.
Maltese: Wara amministrazzjoni mill-ħalq ta' doża waħda ta' 10 mg sildenafil, Cmax kien ikkalkulat f'konċentrazzjoni ta' 24, 53 u 85ng/ml għal pazjenti bil-piż ta' 70, 20 u 10 kg, rispettivament.
English: Metabolism and nutrition disorders Common fluid retention
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: The following serious adverse events were considered to be treatment related, enterocolitis, convulsion, hypersensitivity, stridor, hypoxia, neurosensory deafness and ventricular arrhythmia.
Maltese: Kien ikkunsidrat li l-avvenimenti avversi serji li ġejjin kienu relatati mat-trattament, enterokolite, konvulżjoni, ipersensittività, stridor, nuqqas ta' ossiġenu fit-tessuti, truxija newrosensorja u arritmija ventrikulari.
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: Konsistenti ma' l-effetti magħrufa tiegħu fuq il-pathway nitric oxide / cGMP ( ara sezzjoni 5.1), sildenafil intwera li jsaħħaħ l-effetti ipotensivi tan-nitrati, u għalhekk il-ko-amministrazzjoni tiegħu ma' donaturi ta' nitric oxide jew nitrati f'xi forma oħra hija kontra-indikata ( ara sezzjoni 4.3).
English: Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day).
Maltese: Il-pazjenti ntgħażlu b'mod każwali għal plaċebo jew għal sildenafil (20 mg tliet darbiet kuljum) bl-għoti flimkien ma' bosentan (62.5-125 mg darbtejn kuljum).
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 lużu ta' supplimenti ta' arginine, nitrates, alpha-blockers u inibituri b'saħħithom ta' CYP450 3A4.
English: Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Maltese: Dożi orali singoli ta' sildenafil sa 100 mg f'voluntiera b'saħħithom ma pproduċew l-ebda effett klinikament relevanti fuq l-ECG.
English: When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group.
Maltese: Meta kienu analizzati mill-Klassi Funzjonali tal-WHO, żieda fis-6MWD, statistikament sinifikattiva, kienet osservata fil-grupp tad-doża ta' 20mg.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu
English: A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions.
Maltese: Studju b'mod każwali, double-blind, ikkontrollat bi plaċebo twettaq fuq 278 pazjent bi pressjoni għolja tal-pulmun primarja, PAH assoċjata ma' mard tat-tessut konnettiv, u PAH wara kirurġija ta' feriti konġenitali tal-qalb.
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 fid- demm).
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: 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: Laboratori Fundació DAU C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain or
Maltese: Laboratori Fundació DAU C/ C, 12-14
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: Granpidam 20 mg film-coated tablets Sildenafil
Maltese: Granpidam 20 mg pilloli miksijin b'rita Sildenafil
English: The population pharmacokinetic analysis in pulmonary arterial hypertension patients 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: 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: PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta'PDE5, bħal sildenafil, iżidu l-effetti ipotensivi ta' din ilmediċina.
English: Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1).
Maltese: Amministrazzjoni ta' sildenafil mill-ħalq flimkien ma' epoprostenol mill-vina ġie valutat (ara sezzjoni 4.8 u 5.1).
English: Combined dose groups (n=77)
Maltese: Doża baxxa (n=24) Doża medja (n=26) Doża għolja (n=27) Gruppi li qed jirċievu dożi kkombinati (n=77)
English: 23 subjects experienced clinical worsening events in the placebo group (17.6%) compared with 8 subjects in the sildenafil group (6.0%).
Maltese: Tlieta u għoxrin suġġett fil-grupp tal-plaċebo (17.6%) esperjenzaw avvenimenti kliniċi li marru għall-agħar meta mqabbla mat-tmien suġġetti fil grupp ta' sildenafil (6.0%).
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: Il-frekwenza totali ta' waqfien f'pazjenti trattati b'sildenafil/epoprostenol minħabba effetti avversi kienet ta' 5.2 % meta mqabbla ma' 10.
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Maltese: Fi studji kliniċi, ġie muri li riociguat jżid leffetti ipotensivi tal-inibituri ta' PDE5.
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: 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: Ear and labyrinth disorders Common vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Komuni
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta' newropatija anterjuri iskimika, mhux arteritika tal-għajnejn, kundizzjoni rari, ġew irrapportati b'mod spontanju fi studju osservazzjonali b'konnessjoni ma' kura b'sildenafil u inibituri oħrajn ta' PDE5 (ara sezzjoni 4.8).
English: Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Maltese: Mill-erbgħa u disgħin suġġett li rrapurtaw avveniment avvers serju, 14/55 (25.5%) suġġett kienu fil-grupp tad-doża baxxa, 35/74 (47.3%) kienu fil-grupp tad-doża medja, u 45/100 (45%) kienu fil-grupp tad-doża għolja.
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 fleffikaċja 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: In case of clinical deterioration in spite of Granpidam treatment, alternative therapies should be considered.
Maltese: F'każ ta'deterjorament kliniku minkejja trattament bi Granpidam, għandhom jiġu kkunsidrati terapiji alternattivi.
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: Granpidam 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: Granpidam jintuża fl-adulti, tfal u adoloxxenti ta' età ta' bejn sena u 17-il sena għat-trattament ta' pressjoni għolja fil-kanali tad-demm fil-pulmun (pressjoni arterjali pulmonari għolja).
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: Studies in vitro have shown that sildenafil is selective for PDE5.
Maltese: Studji in vitro wrew li sildenafil huwa selettiv għal PDE5.