FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Maltese: Is-sigurtà ta' sildenafil ma ġietx studjata f'dawn is-sotto gruppi ta' pazjenti li ġejjin, u għalhekk l-użu tiegħu huwa kontra-indikat: indeboliment sever tal-fwied, pressjoni baxxa (pressjoni tad-demm <90/50 mmHg), storja reċenti ta' puplesija jew attakk tal-qalb u mard magħruf ereditarju ta' deġenerazzjoni tar-retina bħal retinitis pigmentosa (minoranza ta' dawn il-pazjenti għandhom mard ġenetiku ta' fosfodiesterażi retinali).
English: NAME OF THE MEDICINAL PRODUCT Sildenafil Actavis 25 mg film-coated tablets Sildenafil Actavis 50 mg film-coated tablets Sildenafil Actavis 100 mg film-coated tablets
Maltese: Sildenafil Actavis 25 mg pilloli miksija b'rita Sildenafil Actavis 50 mg pilloli miksija b'rita Sildenafil Actavis 100 mg pilloli miksija b'rita
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-krejatinina=30-80 mL/min), ilfarmakokinetiċi ta' sildenafil ma tbiddlux wara doża orali waħda ta' 50 mg.
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 sever tal-kliewi (tneħħija tal-krejatinina <30 mL/min), il-tneħħija ta' sildenafil naqset, u wasslet għal żidiet medji ta' tal-AUC u Cmax ta' 100% u 88% rispettivament meta mqabbel ma' voluntiera tal-istess età mingħajr insuffiċjenza tal-kliewi.
English: Sildenafil Actavis 50 mg film-coated tablets
Maltese: Sildenafil Actavis 50 mg pilloli
English: Sildenafil Actavis 25 mg film-coated tablets sildenafil
Maltese: Sildenafil Actavis pilloli tal-25 mg sildenafil
English: There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
Maltese: Ma kienx hemm effett fuq il-morfoloġija jew motilità tal-isperma wara dożi orali ta' 100 mg il-waħda ta' sildenafil f'voluntiera b'saħħithom (ara sezzjoni 4.6).
English: In order for Sildenafil Actavis to be effective, sexual stimulation is required.
Maltese: Biex Sildenafil Actavis ikun effettiv, jkun hemm bżonn ta' stimulazzjoni sesswali.
English: Other medicines and Sildenafil Actavis
Maltese: Mediċini oħra u Sildenafil Actavis
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta‘ difetti fil-vista relatati ma' l-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju (ara sezzjoni 4.8).
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Maltese: − Jekk għandek ċertu mard rari mirut tal-għajnejn (bħal retinitis pigmentosa).
English: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to100 mg as necessary.
Maltese: Bażata fuq effiċjenza u tollerabilita', id-doża tista' tiżdied f' inkrementi għal 50 mg sa 100 mg skont il-ħtieġa.
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% konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u l-metabolit attiv N-desmethly mqabbel ma' dawk li nstabu f'voluntiera żagħżagħ b'saħħithom (18-45 sena).
English: Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decreased blood flow to parts of the brain, feeling of tightening of the throat, numb mouth, bleeding at the back of the eye, double vision, reduced sharpness of vision, abnormal sensation in the eye, swelling of the eye or eyelid, small particles or spots in your vision, seeing halos around lights, dilation of the pupil of the eye, discolouration of the white of the eye, penile bleeding, presence of blood in semen, dry nose, swelling of the inside of the nose, feeling irritable and sudden decrease or loss of hearing.
Maltese: Rari (jistgħu jaffettwaw sa persuna minn kull 1,000): ħass ħażin, puplesija, attakk tal-qalb, taħbit irregolari tal-qalb, tnaqqis temporanju fil-fluss tad-demm għall-partijiet tal-moħħ, sensazzjoni ta' issikkar tal-gerżuma, ħalq inemnem, emoraġija fuq wara tal-għajn, vista doppja, preċiżjoni mnaqqsa tal-vista, sensazzjoni mhux normali fil-għajn, nefħa tal-għajn jew tal-kappell tal-għajn, partiċelli żagħar jew tikek fil-vista tiegħek, jaraw ċrieki madwar id-dwal, dilazzjoni tal-ħabba tal-għajn, tibdil fil-kulur tal-abjad tal-għajn, fsada tal-pene, demm fis-semen, imnieħer xott, nefħa fin-naħa ta' ġewwa tal-imnieħer, tħossok irritabbli u tnaqqis jew telf f'daqqa tas-smigħ.
English: Penile haemorrhage, Priapism, Haematospermia, Erection increased
Maltese: Prijapiżmu,* Ematospermja, Erezzjoni miżjuda
English: *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased
Maltese: Kloropsia, Kromatopsija, Sijanopsja, Eritropsia u Xantopsja *** Disturbi fil-ħruġ tad-dmugħ:
English: - Seizures or fits - this occurs rarely
Maltese: Tnaqqis jew telf fil-vista f'daqqa - din iseħħ b'mod rari
English: Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.
Maltese: Għalhekk, l-għoti konkomitanti ta' indutturi qawwija ta' CYP3A4, bħal rifampin, huwa mistenni li jikkawża tnaqqis ikbar fil-konċentrazzjonijiet fil-plażma ta 'sildenafil.
English: OTHER
Maltese: DETENTURI
English: Sildenafil Actavis 50 mg film-coated tablets sildenafil
Maltese: Sildenafil Actavis pilloli tal-50 mg pilloli Sildenafil
English: Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg of sildenafil.
Maltese: Kull pillola fiha sildenafil ċitrat ekwivalenti għal 25, 50 or 100 mg ta' sildenafil. Eċċipjent b'effett magħruf:
English: Each tablet contains 25 mg of sildenafil (as citrate).
Maltese: Kull pillola fiha 25 mg ta' sildenafil (bħala ċitrat).
English: Sildenafil Actavis 100 mg film-coated tablets sildenafil
Maltese: Sildenafil Actavis pilloli tal-100 mg sildenafil
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Maltese: Studji in vitro wrew li sildenafil huwa selettiv għal PDE5, li huwa nvolut fil-proċess tal-erezzjoni.
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Maltese: Komuni (jistgħu jaffettwaw sa persuna minn kull 10): dardir, ħmura fil-wiċċ, fwawar tas-sħana (sintomi jinkludu sensazzjoni f'daqqa ta' sħana fin-naħa ta' fuq tal-ġisem tiegħek), indiġestjoni, vista mżewqa (b'xi kulur), vista mċajpra, disturbi fil-vista, imnifsejn miżduda u sturdament.
English: Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Maltese: Sustanzi għal kura ta' problema tal-erezzjoni fosthom sildenafil, għandhom jintużaw b'kawtela f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrosi fil-korpus kavernożum jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas-sickle cell, majeloma multipla jew lewkemija).
English: When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Maltese: Meta l-pathway NO/cGMP tiġi attivata, bħal ma jiġri bi stimulazzjoni sesswali, inibizzjoni ta' PDE5 minn sildenafil tirriżulta f'livelli aktar għoljin ta' cGMP fil-corpus cavernosum.
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Maltese: Każijiet ta' newropatija anterjuri iskemika, mhux arterika, tal-għajn, kundizzjoni rari, relatati mal-amministrazzjoni ta' sildenafil u inibituri ta' PDE5 oħrajn ġew irrapportati b'mod spontanju fi studju ta' (ara sezzjoni 4.8)..
English: The tablets are provided in blister packs containing 1, 2, 4, 8, 12 or 24 tablets.
Maltese: Il-pilloli jiġu f'folji li fihom 1, 2, 4, 8, 12 jew 24 pillola.
English: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
Maltese: Inibituri ta' CYP3A4 aktar b'saħħithom bħal ketoconazole u itraconazole jkunu mistennija li jkollhom effetti akbar.
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 ta' interazzjoni, fejn sildenafil (100 mg) kien ko-amministrat ma' amlodipine f'pazjenti bi pressjoni għolja, kien hemm aktar tnaqqis filpressjoni sistolika tad-demm f'pożizzjoni minduda ta' 8 mmHg.
English: In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Maltese: Fil-każ ta' erezzjoni li tippersisti għal aktar minn 4 sigħat, il-pazjent għandu jfittex assistenza medika immedjata.
English: ANNEX II
Maltese: IS-220
English: In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Maltese: Fi provi kliniċi kontrollati, r-rata ta' diskontinwazzjoni minħabba sildenafil kienet baxxa u simili ma' tal-plaċebo.
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Maltese: L-ossidu nitriku mbagħad jattiva l-enżima guanylate cyclase, li tirriżulta f'livelli miżjuda ta' monofosfat tal-gwanosina ċikliku(cGMP), li tipproduċi rilassament tal-muskoli lixxi fil-corpus cavernosum u tikkawża d-dħul tad-demm.
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Maltese: Dan it-tnaqqis ulterjuri fil-pressjoni taddemm kien jixbah lil dak li seħħ meta sildenafil ġie amministrat waħdu lil voluntiera b'saħħithom (ara sezzjoni 5.1).
English: Each tablet contains 100 mg of sildenafil (as citrate).
Maltese: Kull pillola fiha 100 mg ta' sildenafil (bħala ċitrat).
English: Each tablet contains 50 mg of sildenafil (as citrate).
Maltese: Kull pillola fiha 50 mg ta' sildenafil (bħala ċitrat).
English: Drinking alcohol can temporarily impair your ability to get an erection.
Maltese: Ix-xorb alkoħoliku jista' temporanjament ifixkel l-abilità tiegħek li jkollok erezzjoni.
English: This is most likely to occur within 4 hours post sildenafil dosing.
Maltese: Huwa probabbli li dan iseħħ fi żmien 4 sigħat wara li tittieħed id-doża ta' sildenafil.
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Maltese: Minħabba li t-tneħħija ta' sildenafil titnaqqas f'pazjenti b'indeboliment sever tal-kliewi (tneħħija ta' krejatinina <30 mL/min) doża ta' 25 mg għandha tiġi kkunsidrata.
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati minn fost il-pazjenti li użaw sildenafil fl-istudji kliniċi kienu uġigħ ta' ras, fwawar, dispepsja, sadda tal-imnifsejn, sturdament, dardir, fwawar tas-sħana, disturbi fil-vista, ċjanopsija u vista imċajpra.
English: Throat tightness, Nasal oedema, Nasal dryness
Maltese: Għafis fuq ilgerżuma, Edema nażali, Imnieħer xott
English: Sildenafil Actavis will only help you to get an erection if you are sexually stimulated.
Maltese: Sildenafil Actavis tgħinek biss biex ikollok erezzjoni jekk inti tkun stimulat sesswalment.
English: Concomitant use with ritonavir
Maltese: Effetti sekondarji oħrajn:
English: The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Maltese: It-tnaqqis korrispondenti fil-pressjoni dijastolika tad-demm f'pożizzjoni minduda kienet 7 mmHg.
English: Heart rate increased
Maltese: Konġestjoni nażali
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Maltese: M'hemmx informazzjoni dwar l-interazzjoni bejn sildenafil u inibituri tal-fosfodiesterażi mhux speċifiċi bħal theophylline jew dipyridamole.
English: The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil (REVATIO), or other treatments for erectile dysfunction have not been studied.
Maltese: Is-sigurtà u effikaċja ta' taħlit ta' sildenafil ma' inibituri ta' PDE5 oħra, jew kuri oħra għall-pressjoni għolja tal-arterja pulmonari (PAH) li jkollhom sildenafil (REVATIO), jew kuri oħra għal problemi talerezzjoni ma ġewx studjati.
English: Estimated difference 95% confidence interval
Maltese: 95% intervall ta' kunfidenza
English: Powder for oral suspension: Sorbitol
Maltese: Trab għal suspensjoni orali: Sorbitol
English: (p=0.0017) and -320 dyne.sec/cm
Maltese: 5 (p=0.0017) u -320 dyne.sec/cm
English: Date of first authorisation: 28 October 2005 Date of latest renewal: 23 September 2010
Maltese: Data ta' l-aħħar tiġdid: 23 ta' Settembru 2010
English: Пфайзер Люксембург САРЛ, Клон България Pfizer S.A.
Maltese: Пфайзер Люксембург САРЛ, Клон България Pfizer S.A. Тел.:
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 study A1481262 Cmax, CL and AUC (0-8) of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed respectively.
Maltese: Fl-istudju A1481262 Cmax, CL u AUC (0-8) ta' 248 ng/ml, 30.3 l/h u 330 ng h/ml, ġew osservati rispettivament.
English: Possible side effects
Maltese: Effetti Sekondarji Possibbli
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 M).
Maltese: Sildenafil huwa inibitur dgħajjef ta' ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 ( 1C50 > 150 µM).
English: - Copy of the Summary of Product Characteristics (SPC)
Maltese: • Kopja tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC)
English: Revatio 20 mg tablets Sildenafil
Maltese: Revatio 20 mg pilloli Sildenafil
English: The Cmax and AUC (0-8) of the N-desmethyl metabolite were 30.8 ng/ml and 147 ng h/ml, respectively.
Maltese: Is-Cmax u lAUC (0-8) tal-metabolit N-desmethyl kienu ta' 30.8 ng/ml u 147 ng h/ml, rispettivament.
English: figure 8
Maltese: stampa 8
English: Solution for injection 1 vial 10 mg/12.5 ml
Maltese: Soluzzjoni għall-injezzjoni 1 kunjett 10 mg/12.5 ml
English: 90 x 1 tablets in PVC/Aluminium perforated unit dose blisters.
Maltese: 90 x 1 pillola f'folji pperforati tal-PVC/Aluminju ta' doża waħda.
English: EU/1/05/318/001 EU/1/05/318/004 EU/1/05/318/005
Maltese: EU/1/05/318/001 EU/1/05/318/004
English: Infections and infestations Common cellulitis,influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Maltese: Infezzjonijiet u infestazzjonijiet Komuni cellulite, influwenza, bronkite, sinusite, rinite, gastroenterite
English: - The other ingredients are: Powder for oral suspension: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Grape flavour: maltodextrin, grape juice concentrate, gum acacia, pineapple juice concentrate, citric acid anhydrous, natural flavouring
Maltese: Trab għal suspensjoni orali: sorbitol, citric acid anhydrous, sucralose, sodium citrate, xanthan gum, titanium dioxide (E171), sodium benzoate (E211), silica, colloidal anhydrous; Togħma tal-għeneb: maltodextrin, meraq ikkonċentrat tal-għeneb, gum acacia, meraq ikkonċentrat tal-pineapple, citric acid anhydrous, togħma naturali
English: Revatio contains sorbitol
Maltese: Revatio fih sorbitol
English: figure 1
Maltese: stampa 1
English: Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Revatio fiha s-sustanza attiva sildenafil li tifforma parti minn grupp ta' mediċinali msejħa inibituri ta' phosphodiesterase type 5 (PDE 5).
English: • Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Maltese: • Mediċini li fihom nitrati, jew donaturi ta' nitric oxide bħal amyl nitrite (“poppers”).
English: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Maltese: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Franza
English: The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p<0.0001).
Maltese: Il-meded tal-fard rispettivi kienu 2.92 (p=0.0087), 4.32 (p=0.0004) u 5.75 (p<0.
English: • Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
Maltese: • Terapiji oħra għal pressjoni għolja fil-pulmun (e.ż. bosentan, iloprost)
English: - The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Maltese: Qalba tal-pillola: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
English: 5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
Maltese: soluzzjoni ta' 5% ta' glucose soluzzjoni ta' 9mg/mL 0.9% ta' sodium chloride soluzzjoni ta' Lactated Ringer's soluzzjoni ta' 5% ta' glucose/0.
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug.
Maltese: Dan il-metabolu għandu profil selettiv ta' phosphodiesterase simili għal sildenafil u potenza in vitro għal PDE5 bejn wieħed u ieħor 50 % ta' dik tal-mediċina mhux mibdula.
English: The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets.
Maltese: Il-pilloli huma pprovduti f'pakketti ta' folji li fihom 90 pillola, 90 x 1 pillola bħala folji pperforati ta' doża waħda u f'pakketti ta' folji li fihom 300 pillola.
English: figure 9
Maltese: stampa 9
English: Oral suspension Store below 30°C or in refrigerator (2°C to 8°C).
Maltese: Suspensjoni orali Aħżen f'temperatura taħt 30°C jew ġol-friġġ (2°C sa 8°C).
English: Doses up to 80 mg TID were administered and after 3 years 68 % of 133 patients on study treatment were receiving Revatio 80 mg TID.
Maltese: Dożi sa 80 mg TID ġew amministrati u wara 3 snin, 68% minn 133 pazjent kienu qed jirċievu Revatio 80 mg TID bħala trattament ta' waqt l-istudju.
English: Medium dose (n=26)
Maltese: Doża medja (n=26)
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 talplażma.
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: Revatio 10 mg/ml powder for oral suspension
Maltese: Revatio 10 mg/ml trab għal suspensjoni orali
English: Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Maltese: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, il-Belġju.
English: figure 5
Maltese: stampa 5
English: Low dose (n=24)
Maltese: Doża baxxa (n=24)
English: OUTER PACKAGING/CARTON
Maltese: PAKKETT TA' BARRA /KARTUNA
English: 90 film-coated tablets 90 x 1 film-coated tablets 300 film-coated tablets
Maltese: 90 pillola miksijin b'rita 90 x 1 pillola miksija b'rita 300 pillola miksijin b'rita
English: • Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
Maltese: • Terapiji oħra għal pressjoni għolja fil-pulmun (e.ż. bosentan, iloprost).
English: Revatio 10 mg/ml powder for oral suspension Sildenafil
Maltese: Revatio 10 mg/ml trab għal suspensjoni orali Sildenafil
English: Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Maltese: Fareva Amboise, Zone Industrielle, 29 route des Industries , 37530 Pocé-sur-Cisse, Franza.
English: Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) (see section 4.5).
Maltese: (ez. ketoconazole, itraconazole, ritonavir) (ara sezzjoni 4.5).
English: It was judged to be unrelated to the study medicinal product.
Maltese: Kien iġggudikat bħala mhux relatat mal-prodott mediċinali studjat.
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' listudju, 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 taddemm bil-wieqfa ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg rispettivament.
English: figure 7
Maltese: stampa 7
English: Repeat step 3 again.
Maltese: Erġa' irrepeti punt numru 3.
English: figure 3
Maltese: stampa 3
English: LOT
Maltese: Lott
English: Metabolism and nutrition disorders Common fluid retention
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ritenzjoni tal-likwidi
English: Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP.
Maltese: Sildenafil huwa inibitur potenti u selettiv ta' cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), l-enzima li hija responsabli għad-degradazzjoni ta' cGMP. Apparti l-preżenza ta' din l-enzima fil-corpus cavernosum tal-pene, PDE5 huwa preżenti wkoll fil-vaskolatura tal-pulmun.