FrancophonIA/ELRC3.0 huggingface dataset:
English: When a single 100 mg dose of oral 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: 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 għat-test ta' CPET, li jinkludu dawk it-tfal ta' ≥ 7 snin u li żviluppaw biżżejjed biex jagħmlu dan it-test.
English: Common gastritis, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
Maltese: Komuni gastrite, marda tal-gastrooesophageal reflux, murliti, nefħa fl-istonku, ħalq xott
English: Vascular disorders Very common flushing
Maltese: Disturbi vaskulari Komuni ħafna fwawar
English: Blood and lymphatic system disorders Common anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni anemija
English: Common migraine, tremor, paraesthesia, burning sensation, hypoaesthesia
Maltese: Komuni emikranja, , rogħda, parasiteżija, sensazzjoni ta' ħruq, ipoesteżja
English: For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with connective tissue disease.
Maltese: Għal pazjenti bi PAH primarja, l-effett tat-trattament kien ta' 31.1 metri meta mqabbel ma' 7.7 metri għal pazjenti b'PAH assoċjat ma' mard tat-tessut konnettiv.
English: Revatio 0.8 mg/ml solution for injection
Maltese: Revatio 0.8mg/ml soluzzjoni għall-injezzjoni
English: Before you take Revatio).
Maltese: Qabel ma tieħu Revatio).
English: The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ser jaqbel dwar id-dettalji ta' sistema ta' distribuzzjoni kontrollata għall-kunjett ta' 20 ml ta' Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni mal-Awtoritajiet Nazzjonali Kompetenti, u għandu jimplimenta dan il-programm nazzjonali sabiex jassigura li qabel ma jinkiteb mit-tobba, dawn il-professjonisti ta-saħħa li qed jaħsbu biex jiktbu jew jgħatu Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni, huma pprovduti b'dawn id-dokumenti li-ġejjin:
English: • Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
Maltese: • Mediċini li fihom erythromycin, clarithromycin, telithromycin (dawn huma antibijotiċi li jintużaw għat-trattament ta' ċertu infezzjonijiet batterjali), saquinavir (għal HIV) jew nefazodone (għal dipressjoni mentali), għax jista' jkun li d-doża tiegħek ikollha bżonn xi aġġustament.
English: Each 20 ml vial contains 10 mg sildenafil (as citrate).
Maltese: 20 ml fih 20mg sildenafil (bħala citrate).
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of oral suspension) three times a day for children and adolescents weighing over 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 (1 ml ta' suspensjoni orali) tlett darbiet kuljum fit-tfal u adoloxxenti li jiżnu 20 kg jew anqas, jew 20 mg (2 ml ta' suspensjoni orali jew pillola waħda) tlett darbiet kuljum fit-tfal u adoloxxenti ta' > 20 kg, ma' likel jew mhux ma' l-ikel.
English: Efficacy of oral sildenafil 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: Revatio solution for injection is for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Maltese: II u III tal-WHO, li kienu preskritti Revatio għall-użu orali, imma li temporanjament ma jistgħux jieħdu terapija orali, għalkemm stabbli klinikament u emodinamikament.
English: Efficacy of intravenous sildenafil in adult patients with pulmonary arterial hypertension (PAH) A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Maltese: Doża ta' 10 mg dose ta' Revatio soluzzjoni għall-injezzjoni, hija prevvista li tesponi sildenafil u lmetabolit tiegħu b'effetti farmakoloġiki għall-livelli kumparabbli għall-doża mill-ħalq ta' 20mg.
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: Paediatric population
Maltese: Popolazzjoni Pedjatrika
English: What Revatio looks like and contents of the pack Each pack of Revatio solution for injection contains one 20 ml clear glass vial, which is closed with a chlorobutyl rubber stopper and an aluminium seal.
Maltese: Id-dehra ta' Revatio u l-kontenuti tal-pakkett Kull pakkett ta' Revatio soluzzjoni għall-injezzjoni fih kunjett ta' 20 ml, tal-ħġieġ ċar, magħluq b'tapp tal-gomma chlorobutyl u siġill ta' l-aluminjum.
English: Grape flavour:
Maltese: Kodiċi ATC:
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: Glucose Water for injections
Maltese: Glukosju Ilma għall-injezzjonijiet
English: Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle.
Maltese: Kejjel 30 ml ta' ilma billi timla t-tazza tal-kejl (inkluża fil-kartuna) sal-linja mmarkata mbagħad ferra ġol-flixkun.
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 Revatio 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' Revatio li jingħata tlett darbiet kuljum, jew plaċebo.
English: IMMEDIATE PACKAGING/BLISTER
Maltese: PAKKETT EWLIENI/FOLJA
English: The recommended dose of 10 mg requires a volume of 12.5 ml, to be administered as an intravenous bolus injection.
Maltese: Id-doża rakkomandata ta' 10 mg għandha bżonn volum ta' 12.5 ml, sabiex tkun amministrata fil-vina kollha f'daqqa.
English: Each pack also contains a polypropylene measuring cup (graduated to indicate 30 ml), polypropylene oral dosing syringe (3 ml) with HDPE plunger and a LDPE press-in bottle adaptor.
Maltese: Kull pakkett fih ukoll tazza tal-kejl tal-polypropylene (bil-marki tal-kejl li jindikaw 30 ml), siringa talpolypropylene tad-dożaġġ għall-użu orali (3 ml) bil-planġer tal-HDPE u adapter press-in għall-flixkun tal-LDPE.
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: Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at oral 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 ( 1/1000 to ≤ 1/100) and not known (cannot be estimated from the available data).
Maltese: Reazzjonijiet avversi li ġraw f' > 1 % tal-pazjenti ttrattati b'Revatio u li kienu iktar frekwenti (> 1 % differenza) b'Revatio fl-istudju pivitali jew fis-sett ta' tagħrif ikkombinat ta' Revatio, 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 tiġi stmata mittagħrif disponibbli).
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 fittrattament sekondarju, u miżuri sabiex titkejjel il-kwalità tal-ħajja.
English: The most commonly reported adverse reactions that occurred (greater or equal to 10 %)
Maltese: L-aktar reazzjonijiet avversi komuni li seħħew (bi frekwenza ta' ≥ 1%)
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
Maltese: Doża waħda ta' mediċina kontra l-aċidu fl-istonku (magnesium hydroxide/ aluminium hydroxide) ma effettwatx il-bijodisponiblità ta' sildenafil
English: Each ml of reconstituted suspension contains 10 mg of sildenafil (as citrate).
Maltese: Kull ml ta' suspensjoni rikostitwit fih 10 mg ta' sildenafil (bħala citrate).
English: There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Maltese: Kien hemm reazzjoni avversa waħda f'suġġett li kellu kardijmijopatija iskemika severa, li esperjenza fibrillazzjoni u mewt 6 ijiem wara listudju tal-prodott.
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: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza u interventi dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Maltese: Fatturi ta' riskju kardjovaskulari
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 of low blood pressure (e.g. dizziness, light headedness).
Maltese: • Alpha-blockers (per eżempju doxazosin) għat-trattament ta' pressjoni għolja jew problemi filprostata, għaliex dawn iż-żewġ mediċini flimkien jistaw jirriżultaw fi tnaqqis tal-pressjoni (e.ż. sturdament, tħossok li se jtik ħass hażin).
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: Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with PAH who were already receiving and stable on oral Revatio 20 mg TID.
Maltese: L-istudju A1481262 kien studju f'ċentru wieħed, b'doża waħda, u open-label, sabiex jevalwa issigurta', tolleranza u farmakokinetika ta' doża waħdanija ta' sildenafil (10mg) fil-vina, amministrata kollha f'daqqa f'pazjenti li jbatu minn PAH, li kienu jirċievu Revatio 20mg TID mill-ħalq u kienu stabbli fuqu.
English: Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).
Maltese: Erezzjonijiet prolongati u kultant bl-uġigħ kienu rrapurtati fl-irġiel wara li ħadu sildenafil (frekwenza mhux magħrufa).
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051),
Maltese: L-effetti tat-trattament ikkoreġut bi plaċebo f'PVR kien ta' -178 dyne.sec/cm
English: In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with oral Revatio (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 Revatio bħala appendiċi għal epoprostenol mogħti ġol-vini għal pressjoni għolja arterjali tal-pulmun, total ta' 134 pazjent ġew trattati b'Revatio (f'titrazzjoni fissa minn 20 mg għal 40 mg u mbagħad 80 mg, tlett darbiet kuljum, kif ittollerat) u epoprostenol, u 131 pazjent ġew trattati bi plaċebo u epoprostenol.
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 is-sistema riproduttiva u fuq l-iżvilupp.
English: Effects of other medicinal products on intravenous sildenafil Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors should be less than observed after oral sildenafil administration.
Maltese: Effetti ta' prodotti mediċinali oħra fuq sildenafil fil-vina Predizzjonijiet bbażati fuq mudell farmakokinetiku juru li l-effetti ta' bejn mediċina u oħra ma' inibituri CYP3A4 għandhom ikunu inqas minn dawk osservati f'użu ta' sildenafil mill-ħalq.
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: For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤ 20 kg is 10 mg (1 ml of reconstituted suspension) three times a day and for patients > 20 kg is 20 mg (2 ml of reconstituted suspension) three times a day.
Maltese: Użu fil-popolazzjoni pedjatrika (Età ta' bejn sena u 17-il sena) Id-doża rakkomandata f'pazjenti li jiżnu < 20 kg hija ta' 10 mg (1 ml ta' suspensjoni orali rikostitwita ) tlett darbiet kuljum u f'pazjenti li jiżnu > 20 kg id-doża rakkomandata hija ta' 20 mg (2 ml ta' suspensjoni orali rikostitwita) tlett darbiet kuljum.
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: 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: 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 oral 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 mill-ħalq jew il-metabolu prinċipali tiegħu fiċ-ċirkolazzjoni.
English: A total of 207 patients were treated with Revatio 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'Revatio fl-istudju pivitali, u s-stat ta' sopravvivenza fit-tul tagħhom kien assessjat mill-inqas għal 3 snin.
English: Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 4).
Maltese: Erġa' poġġi l-għatu u ħawwad il-flixkun sew għal mhux anqas minn 30 sekonda (stampa 4).
English: Replace the cap and shake the bottle vigorously for a minimum of 30 seconds (figure 2).
Maltese: Erġa' poġġi l-għatu u ħawwad il-flixkun sew għal mhux anqas minn 30 sekonda (stampa 2).
English: Revatio 20 mg film-coated tablets
Maltese: Revatio 20 mg pilloli miksija b'rita
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 todisrupted 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: The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ser jaqbel dwar l-Informazzjoni għallProfessjonisti tas-Saħħa, u il-professjonisti tas-saħħa li ser jkunu infurmati, mal-awtorità nazzjonali kompetenti ta' kull Stat Membru qabel it-tnedija tal-kunjett ta' 20 ml ta' Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni f'dak il-pajjiż.
English: Each pack contains one 20 ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Maltese: Kull pakkett fih kunjett wieħed ta' 20 ml, ċar u tal-ħġieġ tat-tip I, b'tapp ta' gomma chlorobutyl u siġill ta' l-aluminjum.
English: figure 2
Maltese: (stampa 2)
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: 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 tat-trattament mill-bidu tal-istudju double-blind għal suġġetti individwali varja minn 3 sa 3,129 jum.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Din il-mediċina ma għandhiex tingħata lil pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose.
English: Skin and subcutaneous tissue disorders Common alopecia, erythema, night sweats
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni epistassi, sogħla, konġestjoni fl-imnieħer
English: - Information for healthcare professionals
Maltese: • Informazzjoni għall-Professjonisti tas-saħħa
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio than those receiving placebo leading to the premature termination of this study.
Maltese: Fi studju kliniku, rapporti ta' avvenimenti ta' kriżijiet vaso-okklusivi fejn kien meħtieġ dħul fl-isptar kienu aktar komuni f'pazjenti li qed jirċievu Revatio meta mqabbla ma' dawk li qed jirċievu l-plaċebo.
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'saħħithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li jirriżulta f'bejn wieħed u ieħor 90 % tal-konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u lmetabolu attiv N-desmethly mqabbel ma' dawk li nstabu f'voluntiera żagħżagħ b'saħħithom (18-45 sena).
English: In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
Maltese: Fiż-żewġ studji ikkontrollati bi plaċebo effetti negattivi kienu ġeneralment ta' serjetà ħafifa għal moderata.