FrancophonIA/ELRC3.0 huggingface dataset:
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤20 kg or 20 mg three times a day for children and adolescents >20 kg, taken with or without food.
Maltese: Fit-tfal u adoloxxenti ta' età ta' bejn sena u 17-il sena, id-doża rakkomandata hija 10 mg tlett darbiet kuljum fit-tfal u adoloxxenti ta' ≤ 20 kg jew 20 mg tlett darbiet kuljum fit-tfal u adoloxxenti ta' > 20 kg, ma' l-ikel jew mhux ma' l-ikel.
English: In a placebo-controlled study of sildenafil as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
Maltese: Fi studju pivitali kkontrollat bi plaċebo fuq sildenafil bħala appendiċi għal epoprostenol mogħti ġolvini għal pressjoni għolja arterjali tal-pulmun, total ta' 134 pazjent ġew trattati b'sildenafil (f'titrazzjoni fissa minn 20 mg għal 40 mg u mbagħad 80 mg, tlett darbiet kuljum, skont kif ikun ittollerat) u epoprostenol, u 131 pazjent ġew trattati bi plaċebo u epoprostenol.
English: 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: III tal-WHO fil-linja bażi kienet 94 %, 90 %, u 81 %, rispettivament.
English: For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3.
Maltese: Kumbinazzjoni ma' l-aktar inibituri potenti ta' CYP3A4
English: Granpidam is for oral use only.
Maltese: Granpidam huwa għal użu orali biss.
English: PVC/Alu blisters of 300 tablets.
Maltese: Folji tal-PVC/Alu ta' 300 pillola Daqs tal-pakkett huwa ta' kartuna li fiha 300 pillola.
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni saru biss fl-adulti.
English: For subjects with primary PAH (67 subjects), mean changes from baseline were 26.39 m (95% CI: 10.70 to 42.08) and 11.84 m (95% CI: -8.83 to 32.52) for the sildenafil and placebo groups, respectively.
Maltese: sa 42.08) u 11.84 m (95% CI: -8.83 sa 32.52) għall-gruppi ta' sildenafil u tal-plaċebo, rispettivament.
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
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: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development.
Maltese: Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq issistema riproduttiva u fuq l-iżvilupp.
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), ilpressjoni medja tad-demm sistolika u dijastolika waqt is-serħan naqsu b'7 % u 6 % rispettivament mqabbla mal-linja bażi.
English: CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is assumed.
Maltese: Inibituri ta' CYP3A4 bħal clarithromycin, telithromycin u nefazodone huma mistennija li jkollhom effett medju, bejn dak ta' ritonavir u inibituri ta' CYP3A4 bħal Saquinavir jew erythromycin, hija assunta żieda fl-espożizzjoni ta' seba' darbiet iktar.
English: In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27%-60%) higher compared to the lower doses.
Maltese: F'pazjenti bi pressjoni arterjali pulmonari għolja, il-bijodisponibbiltà orali ta' sildenafil wara 80 mg tlett darbiet kuljum kienet bejn wieħed u ieħor ta' 43 % (90 % CI: 27 % - 60 %) ogħla meta mqabbla ma' dik fuq dożi baxxi.
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 l-pożizzjoni.
English: - take medicines for erectile dysfunction.
Maltese: - qed tieħu mediċini għal problema tal-erezzjoni tal-pene.
English: A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥7 years old and developmentally able to perform the test. Children <7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Maltese: Total ta' 106 minn 234 (45 %) suġġett kienu kkunsidrati għal CPET, li jinkludu dawk it-tfal ta' ≥ 7 snin u li żviluppaw biżżejjed biex jagħmlu dan it-test.
English: After oral doses of 20 mg three times a day, the mean maximum total plasma concentration of sildenafil at steady state is approximately 113 ng/ml.
Maltese: Wara dożi orali ta' 20 mg tlett darbiet kuljum, il-medja fil-konċentrazzjonijiet massimi totali fil-plażma ta' sildenafil fi stat fiss hija bejn wieħed u ieħor 113 ng/ml.
English: Of the 278 patients randomised, 277 patients received at least 1 dose of study drug.
Maltese: Minn 278 pazjent fuq bażi każwali, 277 pazjent irċievew ta' l-inqas doża waħda tal-mediċina li qed tiġi studjata.
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Maltese: F'voluntiera b'indeboliment ħafif għal moderat tal-kliewi (tneħħija tal-kreatinina = 30-80 ml/min), ilfarmakokinetiċi ta' sildenafil ma tbiddlux wara li rċievew doża orali waħda ta' 50 mg.
English: A total of 207 patients were treated with sildenafil in the pivotal study, and their long term survival status was assessed for a minimum of 3 years.
Maltese: Total ta' 207 pazjent kienu trattati b'sildenafil fl-istudju pivitali, u s-stat ta' sopravvivenza fit-tul tagħhom kien assessjat mill-inqas għal 3 snin.
English: Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study.
Maltese: Minn 277 suġġett li ġew trattati fl-istudju pivitali, 259 daħlu f'estensjoni ta' l-istudju għal perijodu ta' żmien twil.
English: Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
Maltese: Sildenafil, għalhekk, iżid cGMP fiċ-ċelloli lixxi tal-muskoli vaskulari pulmonari li jsaħħaħ l-effett rilassanti.
English: Treatment with sildenafil significantly delayed the time to clinical worsening of PAH compared to placebo (p = 0.0074).
Maltese: Trattament b'sildenafil dewwem sinifikament iż-żmien biex is-sitwazzjoni klinika ta' PAH meta mqabbla mal-plaċebo (p = 0.0074) tmur għall-agħar.
English: Middlesex
Maltese: Treddigħ
English: How to store Granpidam
Maltese: Kif gћandek tieћu Granpidam
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: sildenafil 20 mg orali tliet darbiet kuljum meta miżjud ma' doża stabbli ta' bosentan (62.5 mg125 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: During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part of the survival follow-up.
Maltese: Waqt li kien għaddej l-istudju, kien hemm total ta' 42 mewta rrapurtata, kemm jekk waqt ittrattament kif ukoll irrappurtar bħala parti mill-monitoraġġ ta' wara t-trattament.
English: However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI: -65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Maltese: Madankollu, għal individwi b'PAH assoċjata ma' mard tattessut konnettiv (36 individwu) il-bidliet medji mil-linja bażi kienu -18.32 m (95% CI: -65.66 sa 29.02) u 17.50 m għall-gruppi ta' sildenafil u tal-plaċebo, rispettivament.
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Maltese: Instabu differenzi ħfief u temporanji ta' diskriminazzjoni tal-kulur ( blu / aħdar ) f'xi pazjenti li wżaw il-Farnsworth-Munsell 100 Hue Test, siegħa wara li ħadu doża ta' 100 mg, u ebda effett ma deher sagħtejn wara d-doża.
English: Cardiovascular risk factors
Maltese: Disturbi gastro-intestinali
English: After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Maltese: Wara dożi kroniċi ta' 80 mg tlett darbiet kuljum lil pazjenti bi pressjoni għolja arterjali tal-pulmun, dehru inqas effetti fit-tnaqqis tal-pressjoni tad-demm (tnaqqis fil-pressjoni kemm dik sistolika kif ukoll dik dijastolika ta' 2 mmHg).
English: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Maltese: Komuni uġigħ ta' ras emikranja, rogħda, parasiteżija, sensazzjoni ta' ħruq, ipoesteżja emorroġija retinali tnaqqis fil-vista, vista mċajpra, fotofobija, kromatopsja, sijanopsja, irritazzjoni fl-għajnejn, iperimija flgħajnejn tnaqqis fl-akutezza tal-vista, diplopja, sensazzjoni anormali fl-għajn
English: A total of 134 patients were treated with sildenafil in the initial study, and their long term survival status was assessed for a minimum of 3 years.
Maltese: Total ta' 134 pazjent kienu trattati b'sildenafil fl-istudju tal-bidu, u listat ta' sopravvivenza fit-tul tagħhom kien assessjat mill-inqas għal 3 snin.
English: The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Maltese: Wara amministrazzjoni orali jew fil-vina, sildenafil jitneħħa bħala metaboli b'mod predominanti flippurgar (bejn wieħed u ieħor 80 % tad-doża orali amministrata) u f'proporzjon anqas fl-awrina (bejn wieħed u ieħor 13 % tad-doża orali amministrata).
English: Pack size of 90 tablets in a carton.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 90 pillola
English: Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) compared to those on placebo.
Maltese: Il-pazjenti li kienu qegħdin jieħdu kwalunkwe doża ta' sildenafil laħqu tnaqqis ta' sinifikat statistiku fil-pressjoni arterjali tal-pulmun medja (mPAP) u reżistenza vaskulari fil-pulmun (PVR) meta mqabbla ma' dawk fuq plaċebo.
English: Most of these adverse reactions were considered mild to moderate in severity.
Maltese: Ħames imwiet addizzjonali ġew irrapurtati sussegwentement.
English: Granpidam can cause dizziness and can affect vision.
Maltese: Granpidam jista' jikkawża sturdament u effetti fuq il-vista.
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Maltese: Fi studju speċifiku fuq l-interazzjonijiet, fejn sildenafil (100 mg) ingħata ma' amoldipine f'pazjenti bi pressjoni għolja, kien hemm tnaqqis addizzjonali fil-pressjoni supine systolic tad-demm ta' 8 mmHg.
English: After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
Maltese: Wara dożi kroniċi ta' 80 mg tlett darbiet kuljum lil pazjenti bi pressjoni għolja sistemika il-bidla medja mil-linja bażi fil-pressjoni sistolika u dijastolika naqset b'9.4 mmHg u 9.1 mmHg rispettivament.
English: Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements.
Maltese: Il-punti tat-tmiem sekondarji kienu jinkludu monitoraġġ tal-parametri emodinamiċi, evalwazzjoni tas-sintomi, klassi funzjonali tal-WHO, bidla fit- trattament sekondarju, u miżuri sabiex titkejjel il-kwalità tal-ħajja.
English: The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Maltese: Kien ikkunsidrat li l-avvenimenti avversi serji li ġejjin kienu relatati mat-trattament u kienu rrapurtati b'mod mhux komuni (jistgħu jaffettwaw sa 1 minn 100 pazjent), reazzjoni allerġika (bħal raxx filġilda, nefħa fil-wiċċ, fix-xofftejn jew fl-ilsien, tħarħir, diffikultà biex tieħu n-nifs jew biex tibla'), konvulżjoni, taħbit tal-qalb mhux regolari, nuqqas ta' smigħ, qtugħ ta' nifs, infjammazzjoni fit-tratt ta' diġestjoni, tħarħir minħabba distrub fil-fluss tal-arja.
English: Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4% and 15% for the low, medium and high dose groups respectively.
Maltese: Titjibfl-indiċi tal-qalb ġie osservat fit-tlett gruppi li qed jirċievu sildenafil meta mqabbla ma dawk li qed jirċievu l-plaċebo, 10 %, 4 % u 15 % għall-gruppi li qed jirċievu doża baxxa, medja u għolja rispettivament.
English: Granpidam can cause a serious increase in the effects of these medicines.
Maltese: Granpidam jista' jżied b'mod serju l-effetti ta' dawn il-mediċini.
English: The adverse reactions profile seen in this paediatric study was generally consistent with that in adults (see table above).
Maltese: Il-profil tar-reazzjonijiet avversi f'dan l-istudju pedjatriku kien ġeneralment konsistenti ma dak fladulti (ara t-tabella hawn fuq).
English: Children and adolescents
Maltese: Użufl-adulti
English: At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision) was increased.
Maltese: Dożi singli ta' 200 mg iriżultaw f'żieda fl-inċidenza ta' reazzjonijiet avversi ( uġigħ ta' ras, ħmura, sturdament, dispepsja, konġestjoni nażali, u vista mibdula).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg ta' sildenafil (bħala citrate).
English: Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual subjects ranged from 3 to 3129 days.
Maltese: Fl-istudji li damu żmien qasir u dawk li damu żmien twil, it-tul totali tattrattament mill-bidu tal-istudju double-blind għal suġġetti individwali varja minn 3 sa 3,129 jum.
English: The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance (6MWD).
Maltese: Il-punt ta' tmiem primarju ta' l-effikaċja kien il-bidla mil-linja bażi fil-ġimgħa 12, fil-mixja ta' 6 minuti (6MWD).
English: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients (see section 4.4).
Maltese: Is-sigurta' u l-effikaċja ta' sildenafil meta amministrat ma' inibituri ta' PDE5 ma ġietx studjata f'pazjenti bi pressjoni arterjali għolja tal-pulmun (ara sezzjoni 4.4).
English: The major circulating metabolite results from N-demethylation of sildenafil.
Maltese: Il-metabolu ċirkulatorju ewlieni jirriżulta minn N-demethylation ta' sildenafil.
English: Galactose intolerance
Maltese: Differenza kkalkulata
English: Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Maltese: Bażata fuq dawn ir-riżultati farmakokinetiċi il-koamministrazzjoni ta' sildenafil ma' ritonavir hija kontra-indikata f'pazjenti bi pressjoni arterjali għolja fil-pulmun (ara sezzjoni 4.3).
English: Pharmacokinetics in special patient groups
Maltese: Farmakokinetiċi fi gruppi speċjali ta' pazjenti
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Maltese: desmethyl, żdiedu b'mod sinifikanti b'154 % u 87 % rispettivament f'suġġetti b'ċirrożi meta mqabbla ma' pazjenti b'funzjoni renali normali.
English: Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Maltese: L-effikaċja klinika, imkejla b'mixja ta' 6 minuti tista' tkun inqas f'pazjenti anzjani.
English: In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Maltese: F'pazjenti bi pressjoni għolja arterjali fil-pulmun, jista' jkun hemm potenzjal għal żieda fir-riskju ta' emorraġija meta sildenafil jinbeda f'pazjenti li diġà qed jużaw antagonista għall-vitamina K, b'mod partikolari f'pazjenti bi pressjoni għolja arterjali fil-pulmun sekondarja għall-mard tat-tessut konnettiv.
English: Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of sildenafil given three times a day, or placebo.
Maltese: Is-suġġetti kienu mqassmin f'wieħed mit-tlett gruppi trattati b'sildenafil, ta' doża baxxa (10 mg), doża medja (10-40 mg) jew doża għolja (20-80 mg) ta' sildenafil li jingħata tlett darbiet kuljum, jew plaċebo.
English: INSTRUCTIONS ON USE
Maltese: Avvenamenti viżwali
English: North Harrow
Maltese: U L-UŻU
English: Priapism
Maltese: Riociguat
English: In 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 b'saħħithom, ma kienx hemm evidenza ta' xi effett ta' azithromycin (500 mg kuljum għal 3 jiem) fuq ir-rata ta' l-eliminazzjoni fissa ta' l-AUC, Cmax u tmax, jew il-half life ta' wara ta' sildenafil jew il- metabolu prinċipali tiegħu fiċ-ċirkolazzjoni.
English: Excipient(s) with known effect
Maltese: Eċċipjent(i) bl-effett magħruf
English: Patients on sildenafil achieved a statistically significant reduction in mean Pulmonary Arterial Pressure (mPAP) compared to those on placebo.
Maltese: Pazjenti fuq sildenafil laħqu tnaqqis fil-medja ta' pressjoni arterjali pulmonari (mPAP) ta' sinjifikat statistiku meta mqabbla ma' plaċebo.
English: Renal and urinary disorders Uncommon haematuria
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni
English: A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo.
Maltese: Żieda fis-6MWD, li kienet statistikament sinifikanti, ġiet osservata fit-3 gruppi ta' dożi ta' sildenafil meta mqabbla ma' dawk fuq plaċebo.
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Maltese: Doża waħda ta' mediċina kontra l-aċidu fl-istonku (magnesium hydroxide/ aluminium hydroxide) ma effettwatx il-bijodisponiblità ta' sildenafil
English: In vivo studies
Maltese: TA' EĊĊIPJENTI
English: Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Maltese: Effetti sekondarji rrapportati b'mod mhux komuni (jistgħu jaffetwaw sa 1 minn kull 100 pazjent) inkludew, tnaqqis fl-akutezza fil-vista, vista' doppja, sensazzjoni mhux normali ta' l-għajn, fsada millpene, preżenza ta' demm fis-semen u/jew fl-awrina u tkabbir tas-sider fl-irġiel.
English: Estimated difference
Maltese: Tqala u treddigħ
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tarriskji).
English: A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
Maltese: Sar studju b'mod każwali, double-blind, ikkontrollat bi plaċebo fuq 267 pazjent b'PAH li kienu stabbilizzati fuq epoprostenol mogħti ġol-vini.
English: In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomized to placebo.
Maltese: Fl-istudju ewlieni ikkontrollat bi plaċebo ta' kif jaħdem sildenafil fuq pressjoni għolja arterjali talpulmun, total ta' 207 pazjent ġew trattati b'mod każwali b'dożi ta' 20 mg, 40 mg, jew 80 mg TID ta' sildenafil u 70 pazjent ingħataw il-plaċebo b'mod każwali.
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.
English: ul.
Maltese: FEJN
English: Suddenly stopping your treatment with Granpidam may lead to your symptoms getting worse.
Maltese: Jekk twaqqaf it-trattament tiegħek bi Granpidam f'daqqa, dan jista' jirriżulta f'aggravar tas-sintomi.