FrancophonIA/ELRC3.0 huggingface dataset:
English: • rifampicin, rifabutin (antibiotics);
Maltese: • rifampicin, rifabutin (antibijotiċi);
English: The full EPAR for Epclusa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Epclusa was well tolerated with a favourable safety profile.
Maltese: Epclusa kien ittollerat tajjeb bi profil tas-sigurtà favorevoli.
English: Epclusa is available as tablets which contain 400 mg sofosbuvir and 100 mg velpatasvir.
Maltese: Epclusa jiġi bħala pilloli li fihom 400 mg sofosbuvir u 100 mg velpatasvir.
English: Sofosbuvir blocks the action of an enzyme called ‘NS5B RNA-dependent RNA polymerase', while velpatasvir targets a protein called ‘NS5A'.
Maltese: Sofosbuvir timblokka l-azzjoni ta' enzima msejħa ‘polimerażi RNA dipendenti fuq NS5B-RNA', filwaqt li velpatasvir tpoġġi fil-mira tagħha proteina msejħa ‘NS5A'.
English: • St John's wort (a herbal preparation used for depression and anxiety).
Maltese: • St John's wort (preparazzjoni erbali li tintuża għad-dipressjoni u l-ansjetà).
English: This is a summary of the European public assessment report (EPAR) for Epclusa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Epclusa.
English: Other information about Epclusa
Maltese: Informazzjoni oħra dwar Epclusa:
English: Sofosbuvir has been authorised as Sovaldi since January 2014.
Maltese: Sofosbuvir ilu awtorizzat bħala Sovaldi minn Jannar 2014.
English: This compared with 84% of patients who were treated with Epclusa alone.
Maltese: Dan tqabbel mal-84 % tal-pazjenti li ġew ikkurati b'Epclusa biss.
English: What are the risks associated with Epclusa?
Maltese: X'inhuma r-riskji assoċjati ma' Epclusa?
English: Looking at the results of the studies together, 98% of patients (1,015 out of 1,035) taking Epclusa for 12 weeks tested negative for the virus 12 weeks after the end of treatment.
Maltese: Meta wieħed jara r-riżultati tal-istudji flimkien, 98 % tal-pazjenti (1,015 minn 1,035) li ħadu Epclusa għal 12-il ġimgħa ittestjaw negattivi għall-virus 12-il ġimgħa wara ttmiem tal-kura.
English: The active substances in Epclusa, sofosbuvir and velpatasvir, block two proteins essential for the hepatitis C virus to multiply.
Maltese: Is-sustanzi attivi f'Epclusa, sofosbuvir u velpatasvir, jimblokkaw żewġ proteini essenzjali sabiex jimmultiplika l-virus tal-epatite Ċ.
English: Epclusa contains the active substances sofosbuvir and velpatasvir.
Maltese: Epclusa fih is-sustanzi attivi sofosbuvir u velpatasvir.
English: Why is Epclusa approved?
Maltese: Għaliex ġie approvat Epclusa?
English: Epclusa is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Maltese: Epclusa huwa mediċina antivirali użata biex tikkura adulti b'epatite Ċ kronika (fit-tul), marda infettiva li taffettwa l-fwied, ikkawżata mill-virus tal-epatite Ċ .
English: Results showed that patients treated for 12 weeks with Epclusa in combination with ribavirin obtained the best results, with around 94% of patients (82 out of 87) testing negative for the virus 12 weeks after the end of treatment.
Maltese: Ir-riżultati wrew li l-pazjenti kkurati għal 12-il ġimgħa b'Epclusa flimkien ma' ribavirin kisbu l-aħjar riżultati, b'madwar 94 % tal-pazjenti (82 minn 87) li ttestjaw negattivi għall-virus 12-il xahar wara t-tmiem tal-kura.
English: Epclusa has been investigated in three main studies involving a total of 1,446 patients infected with hepatitis C (genotypes 1 to 6) whose liver was still able to work adequately but some of whom had compensated liver cirrhosis.
Maltese: Epclusa ġie investigat fi tliet studji ewlenin li jinvolvu t-total ta' 1,446 pazjent infettat bl-epatite Ċ (ġenotip 1 sa 6) li l-fwied tagħhom kien għadu kapaċi jaħdem b'mod xieraq, iżda xi wħud minnhom kellhom ċirrożi tal-fwied ikkumpensat.
English: An additional study was carried out in 267 hepatitis C patients whose liver was not working properly (Child-Pugh class B cirrhosis).
Maltese: Twettaq studju addizzjonali f'267 pazjent bl-epatite Ċ li l-fwied tagħhom ma kienx qed jaħdem sew (ċirrożi Child-Pugh ta' klassi B).
English: Hepatitis C virus occurs in several varieties (genotypes) and Epclusa can be used to treat hepatitis C caused by all genotypes of the virus.
Maltese: Il-virus tal-epatite Ċ iseħħ f'varjetajiet differenti (ġenotipi) u Epclusa jista' jintuża biex jikkura l-epatite Ċ kkawżata mill-ġenotipi kollha tal-virus.
English: Clearance was also very high in patients whose liver is not working properly (Child-Pugh class B cirrhosis), when treated with Epclusa in combination with ribavirin.
Maltese: L-ikklerjar tal-virus ġie nnutat fil-ġenotipi kollha inkluż il-ġenotip 3. L-ikklerjar kien ukoll għoli ħafna fil-pazjenti li l-fwied tagħhom mhux qed jaħdem sew (ċirrożi ChildPugh ta' klassi B), meta ġew ikkurati b'Epclusa flimkien ma' ribavirin.
English: The addition of ribavirin to Epclusa may also be considered for patients who have compensated liver cirrhosis (scarring of the liver but the liver is still able to work adequately) and are infected with genotype 3 hepatitis C virus, a variety which is more difficult to treat.
Maltese: Iż-żieda ta' ribavirin ma' Epclusa tista' wkoll titqies għal pazjenti b'ċirrożi tal-fwied kumpensat (ċikatriċi fil-fwied iżda l-fwied ikun għadu kapaċi jaħdem b'mod xieraq) u li huma infettati bil-virus tal-epatite Ċ tal-ġenotip 3, varjetà li hija iżjed diffiċli biex tiġi kkurata.
English: For the full list of side effects or restrictions with Epclusa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha jew restrizzjonijiet irrapportati b'Epclusa, ara l-fuljett ta' tagħrif.
English: By blocking these proteins, Epclusa stops the hepatitis C virus from multiplying and infecting new cells.
Maltese: Billi jimblokka dawn il-proteini, Epclusa jwaqqaf il-virus tal-epatite Ċ milli jimmultiplika u jinfetta ċelluli ġodda.
English: How does Epclusa work?
Maltese: Kif jintuża Epclusa?
English: 112 capsules
Maltese: 112-il kapsula
English: Mylan S.A.S 117 Allee des parcs 69800 Saint Priest France
Maltese: Mylan S.A.S 117 Allee des parcs 69800 Saint Priest Franza
English: • Severe hepatic impairment,
Maltese: • Indeboliment epatiku gravi,
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Maltese: Il-medja assoluta ta' bijodisponibilità orali hija 41% (medda 25-63%).
English: In-vitro studies
Maltese: Studji in vitro
English: Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Maltese: Infezzjonijiet u infestazzjonijiet Komuni cellulite, influwenza, bronkite, sinusite, rinite, gastroenterite
English: Film coat: hypromellose (6mPas), titanium dioxide (E171) and triacetin.
Maltese: Kisja b'rita: hypromellose (6mPas), titanium dioxide (E171) u triacetin.
English: Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Mysildecard fiha s-sustanza attiva sildenafil li tifforma parti minn grupp ta' mediċinali msejħa inibituri ta' phosphodiesterase type 5 (PDE 5).
English: - The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
Maltese: Qalba tal-pillola: microcrystalline cellulose (PH 102), calcium hydrogen phosphate (anhydrous), croscarmellose sodium u magnesium stearate.
English: The tablets are provided in blisters in packs containing 90, 300 and (90 x 1) tablets.
Maltese: Il-pilloli huma pprovduti f'folji f'pakketti li fihom 90, 300 u (90 × 1) pillola.
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: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Maltese: L-effetti tat-trattament ikkoreġut bi plaċebo f'PVR kien ta' -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) u -320 dyne.sec/cm5 (p<0.
English: Sildenafil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Maltese: Sildenafil huwa kontra-indikat f'pazjenti b'indeboliment renali ta' natura gravi (Child-Pugh klassi C) (ara sezzjoni 4.3).
English: Sildenafil and its major circulating N-desmethyl metabolite are approximately 96% bound to plasma proteins.
Maltese: Sildenafil u l-metabolit maġġur tiegħu fiċ-ċirkolazzjoni, N-desmethyl, huma bejn wieħed u ieħor 96% marbutin mal-proteini tal-plażma.
English: The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2%, 12.9%, 23.3%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%, 5.9%, 14.4%).
Maltese: Il-perċentwali ta' tnaqqis fit-12-il ġimgħa għal sildenafil 20 mg, 40 mg u 80 mg TID f'PVR (11.2%, 12.9%, 23.3%) kien proporzjonalment ikbar mit-tnaqqis fir-reżistenza sistemika vaskolari (SVR) (7.2%, 5.9%, 14.4%).
English: • Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
Maltese: • Pressjoni baxxa ħafna u severa fil-bidu (pressjoni ta' < 90/50 mmHg).
English: Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mmHg (p = 0.01) and -5.1 mmHg (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Maltese: L-effetti tat-trattament ikkoreġut bi plaċebo f'mPAP kien ta'2.7 mmHg (p=0.04), -3.0 mm Hg (p = 0.01) u -5.1 mm Hg (p < 0.0001) għal sildenafil 20 mg, 40 mg u 80 mg TID rispettivament.
English: Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Maltese: II ta' WHO (107/277, 39%) jew III (160/277, 58%) b'mixja ta' 6 minuti ta' 378 metri u 326 metri rispettivament bħala l-linja bażi; inqas pazjenti kienu ta' Klassi I (1/277, 0.4%) jew IV (9/277, 3%) fil-linja bażi.
English: In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively were observed.
Maltese: F'dawn il-popolazzjonijiet ta' l-istudju, ġie osservat tnaqqis addizzjonali medju fil-pressjoni supine systolic u l-pressjoni diastolic ta' 7/7 mmHg, 9/5 mmHg u 8/4 mmHg, rispettivament, u tnaqqis addizzjonali medju fil-pressjoni tad-demm bil-wieqfa ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg rispettivament.
English: In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients > 20 kg; no patients ≤ 20 kg received the low dose), medium (10 mg in patients ≥ 8-20 kg; 20 mg in patients ≥ 20-45 kg; 40 mg in patients > 45 kg) or high dose (20 mg in patients ≥ 8-20 kg; 40 mg in patients ≥ 20-45 kg; 80 mg in patients > 45 kg) regimens of sildenafil and 60 were treated with placebo.
Maltese: Fi studju kliniku kkontrollat bil-plaċebo ta' sildenafil f'pazjenti ta' età ta' bejn sena u 17-il sena bi pressjoni għolja arterjali tal-pulmun, total ta' 174 pazjent kienu ttrattati tlett darbiet kuljum b'doża baxxa (10 mg f'pazjenti ta' > 20 kg; l-ebda pazjent ta' ≤ 20 kg ma ġie mogħti d-doża baxxa), jew b'doża medja (10 mg f'pazjenti ta' ≥ 8-20 kg; 20 mg f'pazjenti ta' ≥ 20-45 kg; 40 mg f'pazjenti ta' > 45 kg) jew b'doża għolja (20 mg f'pazjenti ta' ≥ 8-20 kg; 40 mg f'pazjenti ta' ≥ 20-45 kg; 80 mg f'pazjenti ta' > 45 kg) ta' sildenafil filwaqt li 60 pazjent kienu ttrattati bil-plaċebo.
English: Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg).
Maltese: Sildenafil ma kellu l-ebda effett klinikament sinifikanti fuq il-livelli tal-plażma ta' kontraċettivi orali (ethinyloestradiol 30 mg u levonorgestrel 150 mg).
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) stabilised on doxazosin therapy.
Maltese: Fi tlett studji speċifiċi fuq interazzjonijiet bejn droga u droga, l-alpha blocker doxazosin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg, jew 100 mg) ġew amministrati fl-istess waqt, lil pazjenti bi iperplażja beninn tal-prostata (BPH) stabbilizzati b'kura b'doxazosin.
English: The most common adverse reactions that occurred (with a frequency ≥ 1%) in sildenafil patients (combined doses) and with a frequency > 1% over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Maltese: L-aktar reazzjonijiet avversi komuni li seħħew (bi frekwenza ta' ≥ 1%) f'pazjenti li kienu qed jieħdu sildenafil (dożi kkombinati) u bi frekwenza > 1% meta mqabbla ma' pazjenti li kienu qed jieħdu plaċebo kienu deni, infezzjoni fil-parti ta' fuq tal-passaġġ respiratorju (kull waħda 11.5%), rimettar (10.9%), żieda fl-erezzjonijiet (inkluż erezzjonijiet spontanji tal-pene f'pazjenti rġiel) (9.0%), dardir, bronkite (kull waħda 4.6%), farinġite (4.0%), imħat (3.4%), u pnewmonja, rinite (kull waħda 2.9%).
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and a 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 tal-plażma ta' sildenafil meta ko-amministrat ma' sildenafil (50 mg) fuq voluntiera b'saħħithom.
English: The proportion of subjects receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (47.7%) and the placebo treatment group (41.7%).
Maltese: Il-proporzjon tas-suġġetti li qed jirċievu prodotti mediċinali sabiex jgħinu fil-linja bażi (antikoagulanti, digoxin, calcium channel blockers, dijuretiċi u/jew ossiġnu) kien simili għal grupp trattati b'sildenafil flimkien ma' mediċini oħra (47.7%) u l-grupp tat-trattament bil-plaċebo (41.7%).
English: 90 film-coated tablets 300 film-coated tablets 90 x 1 film-coated tablets
Maltese: 90 pillola miksija b'rita 300 pillola miksija b'rita 90 × 1 pillola miksija b'rita
English: • if you are taking riociguat.
Maltese: - qed/a tieħu riociguat.
English: The estimated difference between the medium sildenafil dose and placebo was 11.33% (95% CI: 1.72 to 20.94) (see Table 2).
Maltese: Id-differenza kkalkulata bejn id-doża medja ta' sildenafil u l-plaċebo kienet ta' 11.33% (95% CI: 1.72-20.94) (ara Tabella 2).
English: The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79%) and PAH associated with connective tissue disease (55/267, 21%).
Maltese: Il-pazjenti b'PAH inkludew dawk bi pressjoni għolja primarja pulmonari u arterjali (212/267, 79%) u PAH assoċjata ma' mard tat-tessut konnettiv (55/267, 21%).
English: The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
Maltese: L-espożizzjoni għal sildenafil f'pazjenti fuq substrati ta' CYP3A4 u substrati ta' CYP3A4 flimkien ma' beta-blockers kienet ta' 43% u 66% ogħla, rispettivament, meta mqabbla ma' pazjenti li ma kienux qegħdin jirċievu dawn il-klassijiet tal-mediċini.
English: What Mysildecard contains - The active substance is sildenafil.
Maltese: X'fih Mysildecard - Is-sustanza attiva hi sildenafil.
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 beta-blockers.
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: 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' 10.7% f'pazjenti ttrattati bi plaċebo/epoprostenol.
English: The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2.9%, 3.0% and 8.5% respectively, compared to 2.9% with placebo.
Maltese: Il-frekwenza totali tat-twaqqif ta' sildenafil f'pazjenti trattati b'dożi ta' 20 mg, 40 mg, jew 80 mg TID kienet 2.9%, 3.0% u 8.5% rispettivament, meta mqabbla ma' 2.9% tal-plaċebo.
English: PVC-Al blisters unit dose perforated blister pack containing 90 x 1 film-coated tablets.
Maltese: Pakkett bil-folji perforati tal-PVC Al li jkun fih 90 × 1 pillola miksija b'rita.
English: Co-administration of oral contraceptives (ethinyloestradiol 30 μg and levonorgestrel 150 μg) did not affect the pharmacokinetics of sildenafil.
Maltese: L-għoti fl-istess ħin ta' kontraċettivi orali (ethinyloestradiol 30 mg u levonorgestrel 150 mg) m'affettwax il-farmakokinetiċi ta' sildenafil.
English: In this trial, 63 of 234 (27%) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Maltese: F'din il-prova, tlieta u sittin minn 234 (27%) pazjent kellhom < 7 snin (doża baxxa ta' sildenafil = 2; doża medja = 17; doża għolja = 28; plaċebo = 16) u 171 minn 234 (73%) pazjent kellhom 7 snin jew aktar (doża baxxa ta' sildenafil = 40; doża medja = 38; u doża għolja = 49; plaċebo = 44).
English: Among these 37 deaths, the number (%) of deaths was 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively.
Maltese: Dost dawn is-37 mewta, in-numru (%) ta' mwiet kien 5/55 (9.1%), 10/74 (13.5%), u 22/100 (22%) fil-gruppi ta' doża baxxa, medja, u għolja ta' sildenafil, rispettivament.
English: • Recent history of stroke or myocardial infarction,
Maltese: • Storja riċenti ta' puplesija jew infart mijokardijaku,
English: Most patients were WHO Functional Class II (68/267, 26%) or III (175/267, 66%); fewer patients were Class I (3/267, 1%) or IV (16/267, 6%) at baseline; for a few patients (5/267, 2%), the WHO Functional Class was unknown.
Maltese: Ħafna mill-pazjenti kienu ta' Klassi Funzjonali II (68/267, 26%) jew III (175/267, 66%) ta' WHO; inqas pazjenti kienu ta' Klassi I (3/267, 1%) jew IV (16/267, 6%) fil-linja bażi; għal xi ftit pazjenti (5/267, 2%), il-Klassi Funzjonali tal-WHO ma kienitx magħrufa.
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 ta' 92%, 81% u 74%, rispettivament.
English: For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Maltese: Għall-pazjenti b'linja bażi fid-distanza koperta bil-mixi ta' ≥325 metri, it-trattament effettiv kien ta' 38.4 metri favur is-sildenafil; għall-pazjenti b'linja bażi fid-distanza koperta bil-mixi ta' < 325 metri, it-trattament effettiv kien ta' 2.3 metri favur il-plaċebo.
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: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Maltese: Sildenafil (50 mg) ma saħħaħx l-effetti ipotensivi ta' l-alkoħol f'voluntiera b'saħħithom b'medja ta' l-ogħla livelli ta' alkoħol fid-demm ta' 80 mg/dl.
English: A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steadystate sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studju ta' pazjenti adulti b'PAH li kienu qed jirċievu terapija b'bosentan fl-isfond (62.5 mg - 125 mg darbtejn kuljum) indikat żieda fl-AUC ta' bosentan (20% (95% CI: 9.8 - 30.8) meta mogħti flimkien ma' sildenafil fl-istat fiss (20 mg tliet darbiet kuljum) ta' qawwa iżgħar milli minn dik li dehret f'voluntiera b'saħħithom meta ngħatalhom flimkien ma' 80 mg ta' sildenafil tliet darbiet kuljum (ara sezzjonijiet 4.4 u 5.1).
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: 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: 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: Is-suġġetti (38% 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: 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.