FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with 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: Mysildecard 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: Mysildecard 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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu.
English: Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni epistassi, sogħla, konġestjoni fl-imnieħer
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: 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: 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, fiż-żewġ 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 tittieħed stima mit-tagħrif disponibbli).
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: 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: Each tablet contains 20 mg of sildenafil (as the citrate).
Maltese: Kull pillola fiha 20 mg ta' sildenafil (bħala citrate).
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 tal-pulmun.
English: Anhydrous calcium hydrogen phosphate
Maltese: Microcrystalline cellulose (PH 102) Anhydrous calcium hydrogen phosphate Croscarmellose sodium
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' 20 mg.
English: The most common serious adverse events that occurred with a frequency ≥ 1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Maltese: L-aktar avvenimenti avversi serji komuni li seħħew bi frekwenza ta' ≥ 1% f'pazjenti li qed jirċievu sildenafil (dożi kkombinati) kienu pnewmonja (7.4%), insuffiċjenza kardijaka, pressjoni għolja fil-pulmun (5.2% f'kull wieħed), infezzjoni fil-parti ta' fuq tas-sistema respiratorja (3.1% f'kull wieħed), insuffiċjenza ventrikulari fin-naħa tal-lemin, gastroenterite (2.6%
English: A total of 234 subjects aged 1 to 17 years were treated in a randomised, 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, double-blind, multi-ċentriku, ikkontrollat fl-istess ħin bi grupp li ngħata l-plaċebo, u dożi varji.
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 20 mg darba kuljum hija rakkomandata f'każijiet ta' amministrazzjoni flimkien ma' inibituri ta' CYP3A4 aktar b'saħħithom bħal clarithromycin, telithromycin u nefazodone.
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: Marketing Authorisation Holder: Mylan S.A.S
Maltese: FIS-SUQ Mylan S.A.S
English: INFORMATION IN BRAILLE Mysildecard 20 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Mysildecard 20 mg pilloli miksija b'rita
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: Mysildecard can cause dizziness and can affect vision.
Maltese: Mysildecard jista' jikkawża sturdament u effetti fuq il-vista.
English: Veno-occlusive disease
Maltese: Disturbi gastro-intestinali
English: Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomised, 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: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 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 200% u 79% rispettivament f'pazjenti b'indeboliment gravi meta mqabbla ma' suġġetti b'funzjoni renali normali.
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: • Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
Maltese: • Alpha-blockers (per eżempju doxazosin) għat-trattament ta' pressjoni għolja jew problemi fil-prostata, għaliex dawn iż-żewġ mediċini flimkien jistaw jirriżultaw fi tnaqqis tal-pressjoni (e.ż. sturdament, tħossok li se jtik ħass hażin).
English: Efficacy in adult patients with pulmonary arterial hypertension (PAH) 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: Effikaċja f'pazjenti adulti bi pressjoni għolja arterjali pulmonari (PAH) 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).PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
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: 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 tax-xellug < 45% jew bi frazzjoni ta' tnaqqis fil-ventrikola tax-xellug < 0.2 ma ġewx studjati.
English: Patients were randomised 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: 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; fil-pazjenti 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: 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 fl-adulti (ara t-tabella hawn fuq).
English: Other medicines and Mysildecard
Maltese: Mediċini oħra u Mysildecard
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: 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: Mysildecard 20 mg film-coated tablets sildenafil
Maltese: Mysildecard 20 mg pilloli miksijin b'rita sildenafil
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: Common migraine, tremor, paraesthesia, burning sensation, hypoaesthesia
Maltese: Komuni emikranja, rogħda, parasiteżija, sensazzjoni ta' ħruq, ipoesteżja
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 case of clinical deterioration in spite of Mysildecard treatment, alternative therapies should be considered.
Maltese: F'każ ta'deterjorament kliniku minkejja trattament b'Mysildecard, għandhom jiġu kkunsidrati terapiji alternattivi.
English: Mysildecard with food and drink You should not drink grapefruit juice while you are being treated with Mysildecard.
Maltese: Mysildecard ma' ikel u xorb Tixrobx meraq tal-grejpfrut waqt li qed tiġi trattat b'Mysildecard.
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: 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 ġol-vini 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: 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: 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), il-farmakokinetiċi ta' sildenafil ma tbiddlux wara li rċievew doża orali waħda ta' 50 mg.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 20 mg ta' sildenafil (bħala citrate).
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: When sildenafil and doxazosin were administered simultaneously to patients stabilised 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: 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-ko-amministrazzjoni ta' sildenafil ma' ritonavir hija kontra-indikata f'pazjenti bi pressjoni arterjali għolja fil-pulmun (ara sezzjoni 4.3).
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: 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: 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: A white, round, biconvex film-coated tablet (approximately 6.5 mm diameter), debossed with M on one side of the tablet and SL over 20 on the other side.
Maltese: Pillola miksija b'rita, bajda, tonda, bikonvessa (b'dijametru ta' madwar 6.5 mm), imnaqqxa b'M fuq naħa waħda tal-pillola u SL fuq 20 fuq in-naħa l-oħra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1134/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1134/001
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 fl-ippurgar (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: 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 tat-tessut 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: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Mylan Hungary Kft.
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Mylan Hungary Kft.
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 fil-ġilda, 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: NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets sildenafil
Maltese: TAL-PRODOTT MEDIĊINALI Mysildecard 20 mg pilloli miksija b'rita sildenafil
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: Titjib fl-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: Mysildecard can cause a serious increase in the effects of these medicines.
Maltese: Mysildecard jista' jżied b'mod serju l-effetti ta' dawn il-mediċini.
English: Before you take Mysildecard)
Maltese: Qabel ma tieħu Mysildecard)