FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a lack of confirmatory evidence regarding the maintenance of efficacy and the long-term safety, which has not been provided by the open-label extension study phase, due to its methodological limitations.
Maltese: Hemm nuqqas ta' evidenza konfermatorja rigward iż-żamma tal-effikaċja u s-sigurtà fit-tul, li ma ġietx ipprovduta minn fażi ta' studju ta' estensjoni open-label, minħabba l-limitazzjonijiet metodoloġiċi tiegħu.
English: The CHMP agreed that the risk of physical dependence and associated withdrawal reaction can be mitigated and adequately managed by the strengthened tapering advice proposed.
Maltese: Is-CHMP qabel li r-riskju ta' dipendenza fiżika u ta' reazzjoni ta' rtirar assoċjata jista' jitnaqqas u jiġi ġestit b'mod adegwat bil-parir imsaħħa ta' tnaqqis propost.
English: The results of the pivotal phase III clinical study are considered robust and consistent with respect to primary and secondary efficacy parameters (addressing severity and impact of the disease and quality of life) as well as with respect to responder rates and various subgroup analyses.
Maltese: III huma kkunsidrati robusti u konsistenti fir-rigward ta' parametri ta' effikaċja primarji u sekondarji (jindirizzaw is-severità u l-impatt tal-marda u l-kwalità ta' ħajja) kif ukoll fir-rigward ta' rati ta' dawk li rrispondew u analiżijiet varji tas-sottogruppi.
English: • The Committee reviewed all available data in support of the safety and efficacy of Oxynal and Targin and associated names in “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy”.
Maltese: • Il-Kumitat irreveda kull dejta disponibbli f'appoġġ għas-sigurtà u effikaċja ta' Oxynal u Targin u ismijiet assoċati f'“kura sintomatika tat-tieni linja għal pazjenti b'sindromu ta' riġlejn irrekwieti idjopatiku sever sa sever ħafna wara falliment ta' terapija dopaminerġika”.
English: Compared to other opioids, a lower potential for psychological dependence and abuse is further expected with OXN PR, as it is a prolonged release formulation whereas it is currently accepted knowledge that the risk of psychological dependence increases with faster drug release.
Maltese: Meta mqabbel ma' opjojdi oħrajn, huwa mistenni wkoll potenzjal iżgħar għal dipendenza psikoloġika u abbuż b'OXN PR, minħabba li huwa formulazzjoni għal rilaxx fit-tul filwaqt li huwa għarfien attwalment aċċettat li r-riskju ta' dipendenza psikoloġika jiżdied b'rilaxx aktar mgħaġġel tal-mediċina.
English: Furthermore, the risk of parenteral or intranasal misuse of OXN PR by individuals dependent on opioid agonists is expected to be low as marked withdrawal symptoms are expected due to the opioid receptor antagonist characteristics of naloxone.
Maltese: Barra minn hekk, ir-riskju ta' użu ħażin parenterali jew intranażali ta' OXN PR minn individwi dipendenti fuq agonisti tal-opjojdi huwa mistenni li jkun baxx minħabba sintomi notevoli ta' rtirar huma mistennijha minħabba l-karatteristiċi ta' antagonist ta' riċetturi tal-opjojdi ta' naloxone.
English: In order to demonstrate the efficacy and safety of OXN PR in the symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy, the application dossier was based on a pivotal phase III clinical study (No OXN 3502) and open label extension study phase (No OXN 3502S).
Maltese: III (Nru OXN 3502) u fażi ta' estensjoni ta' studju open label (Nru OXN 3502S).
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, migraine, lethargy (lack of energy), psychomotor hyperactivity (restlessness with increased activity), dizziness, somnolence (sleepiness), hypertension (high blood pressure), abdominal pain (stomach ache), dyspepsia (heartburn), mouth ulcers, dry mouth, hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), dermatitis (skin inflammation), night sweats, pruritus (itching), rash, dry skin, pain in the extremities (arms and legs), symptoms of the menopause, asthenia (weakness), chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests and increased weight.
Maltese: Minkejja dan, l-effetti sekondarji li ġejjin jidhru f'bejn pazjent 1 u 10 minn kull 1,000: irritabilità, nervi, ma jkollkx kwiet, insomnja, ħolm anormali, ansjetà, migranji, letarġija, attività psikomotriċi żejda (żieda fl-attivita fiżika), sturdament, sonnolenza, ipertensjoni, (pressjoni għolja), uġigħ ta' żaqq, dispepsija, ulċeri fil-ħalq, ħalq xott, iperbilirubinaemia (livelli għolja fid-demm ta' bilirubin, prodott li jfarrak iċ-ċelloli ħomor, li jista' jikkawża s-sfurija talġilda u l-għajnejn), dermatite (infjammazzjoni tal-ġilda), għaraq matul il-lejl, prurite (ħakk), raxx, ġilda xotta, uġigħ fit-truf (idejn u saqajn), sintomi tal-menopawsa, astenja (dgħjufija), uġigħ fis-sider, glikosurja (zokkor fl-awrina), proteinuria (proteina fl-awrina), testijiet ta' funzjoni anormali tal-fwied u żieda fil-piż.
English: This summary was last updated in 05-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 05-2010.
English: The active substance in Circadin, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Maltese: Is-sustanza attiva f'Circadin, melatonin, hu ormon naturali, li normalment jiġi prodott minn glandola fil-moħħ magħrufa bħala l-pineal gland.
English: This document is a summary of the European Public Assessment Report (EPAR) for Circadin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Circadin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Circadin to Rad Neurim Pharmaceuticals EEC Limited on 29 June 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Circadin lil Rad Neurim Pharmaceuticals EEC Limited fid-29 ta' Ġunju 2007.
English: Circadin is a medicine that contains the active substance melatonin.
Maltese: Circadin hu mediċina li fiha s-sustanza attiva melatonin.
English: Circadin has been compared with placebo (a dummy treatment) in three main studies involving a total of 681 patients aged over 55 years with primary insomnia.
Maltese: Circadin tqabbel ma' plaċebo (trattament finta) fi tliet studji ewlenin li fihom ħadu sehem total ta' 681 pazjent ta' iktar minn 55 sena b'insomnja primarja.
English: It is available as white prolongedrelease tablets (2 mg).
Maltese: Hija disponibbli bħala pilloli bojod li jerħu lmediċina bil-mod (2 mg).
English: When the results of all three studies were looked at together, 32% of the patients taking Circadin (86 out of 265) reported a significant improvement in symptoms after three weeks, compared with 19% of those taking placebo (51 out of 272).
Maltese: Meta ngħatat ħarsa lejn ir-riżultati ta' dawn it-tliet studji flimkien, 32% tal-pazjent li kienu qed jieħdu Circadin (86 minn 265) irrappurtaw titjib sinjifikanti fis-sintomi wara tliet ġimgħat, meta mqabbla ma' 19% ta' dawk li kienu qed jieħdu l-plaċebo (51 minn 272).
English: What is the risk associated with Circadin?
Maltese: X'riskji huma assoċjati ma' Circadin?
English: Why has Circadin been approved?
Maltese: Għaliex ġie approvat Circadin?
English: For the full list of all side effects reported with Circadin, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati ma' Circadin, ara l-Fuljett ta' Tagħrif.
English: The patients assessed the severity of their symptoms using a standard questionnaire.
Maltese: Il-pazjenti ivvalutaw is-severità tas-sintomi tagħhom bl-użu ta' kwestjonarju standard.
English: The additional study showed that Circadin was more effective than placebo for at least 13 weeks.
Maltese: L-istudju addizzjoni wera li Circadin kien iktar effettiv mill-plaċebo għal mill-inqas 13-il ġimgħa.
English: ‘Primary' means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
Maltese: 'Primarja' tfisser li l-insomnja ma jkollhiex kawża ta' idetifikazzjoni, fosthom la kawża medika, la mentali u wisq anqas ambjentali.
English: What is Circadin?
Maltese: X'inhu Circadin?
English: This dose can be continued for up to 13 weeks.
Maltese: Id-doża tista' titkompla sa 13-il ġimgħa.
English: Circadin was more effective than placebo at improving quality of sleep and the patients' ability to function normally on the following day.
Maltese: Circadin kien iktar effettiv mill-plaċebo fit-titjib fil-kwalità tal-irqad u l-ħila tal-pazjent li jiffunzjona b'mod normali.
English: Older people may produce less melatonin, leading to the development of insomnia.
Maltese: L-anzjani ġielijipproduċu inqas melatonin, u dan iwassal għall-insomnja.
English: How has Circadin been studied?
Maltese: Kif ġie studjat Circadin?
English: The main measure of effectiveness was the number of patients who reported a significant improvement in their quality of sleep and ability to function normally on the following day, after three weeks of treatment.
Maltese: Il-mezz ewlieni tal-effikaċja kien in-numru ta' pazjenti li rrappurtaw titjib sinjifikanti fil-kwalità tal-irqad u l-abilità li jirritornaw għall-funzjoni normali l-għada, wara tliet ġimgħat ta' kura.
English: Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Maltese: Il-livelli fid demm normalment jiżdiedu wara li jidlam u jilħqu l-ogħla livelli fl-eqqel tal-lejl.
English: Side effects with Circadin are not common.
Maltese: L-effetti sekondarji b'Circadin m'humiex komuni.
English: Because Circadin tablets release melatonin slowly over a few hours, they mimic the natural production of melatonin in the body.
Maltese: Minħabba li l-pilloli ta' Circadin jerħu melatonin bil-mod fuq perjodu ta' ftit sigħat, dawn ikunu qed jimitaw il-produzzjoni naturali tal-melatonin filġisem.
English: Other information about Circadin:
Maltese: Tagħrif ieħor dwar Circadin:
English: Circadin can cause drowsiness, so it should be used with caution if this could pose a risk to safety, including in people who need to drive or use machines.
Maltese: Circadin jista' jwassal għal sturdament, għaldaqstant għandu jittieħed b'kawtela jekk dan ipoġġi f'riskju s-sigurtà tal-pazjent, fosthom f'persuni li jkollhom bżonn isuqu jew jużaw magni.
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Maltese: Il-medja assoluta ta' biodisponibilità orali hija 41% (medda 25-63%).
English: България Актавис ЕАД
Maltese: България Актавис ЕАД Teл:
English: Date of latest renewal: 4 September 2014
Maltese: Data tal-aħħar tiġdid: 4 ta' Settembru 2014
English: BLB 016 Bulebel Industrial Estate Zejtun ZTN 3000
Maltese: BLB 016 Bulebel Industrial Estate Żejtun ZTN 3000
English: System Organ Class
Maltese: Klassi talOrganu
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Maltese: Ilmetabolit N-desmethyl jiġi metabolizzat iżjed, b'half life terminali ta' bejn wieħed u ieħor 4 h.
English: Stevens-Johnson Syndrome (SJS),*
Maltese: Sindromu ta‘ Stevens-Johnson (SJS),* Nekrolisi tossika tal-ġilda (TEN)*
English: Contains lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fih il-lactose monohydrate.
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Maltese: Nicorandil huwa ibridu ta' attivatur tal-kanali tal-potassju u tan-nitrati.
English: In vitro studies
Maltese: Studji in vitro
English: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður Iceland
Maltese: Reykjavíkurvegi 76-78 IS-220 Hafnarfjörður L-Iżlanda
English: Uncommon (³ 1/1000 and
Maltese: Mhux komuni (≥ 1/1000 and
English: Common (³ 1/100 and
Maltese: Komuni (≥ 1/100 and <1/10)
English: See 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku.
English: Reykjavíkurvegi 78 IS-220 Hafnarfjörður Iceland
Maltese: Reykjavíkurvegi 78 IS-220 Hafnarfjörður L-Iżlanda
English: resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
Maltese: 8% fl-AUC ta' bosentan u żieda ta' 42% fis-Cmax bosentan (125 mg b.i.d.).
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50>150 µM).
Maltese: Sildenafil huwa inibitur dgħajjef ta' iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 taċ-ċitokromju P450 (1C50>150 µM).
English: Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Maltese: Filprovi kollha, il-proporzjon ta' pazjenti li rappurtaw titjib bi sildenafil kienu kif ġej: disfunzjoni psikoġenika tal-erezzjoni (84%), disfunzjoni mħallta tal-erezzjoni (77%), disfunzjoni organika talerezzjoni (68%), anzjani (67%), diabetes mellitus (59%), mard iskemiku tal-qalb (69%), pressjoni għolja (68%), TURP (61%), prostatektomija radikali (43%), tidrib fil-kolonna vertebrali (83%), depressjoni (75%).
English: At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Maltese: Bl-ogħla dożi rakkomandati, hemm selettività ta' 80-darba fuq PDE1, u aktar minn 700-darba fuq PDE2, 3, 4, 7, 8, 9, 10 u 11.
English: Specifar ABEE Τηλ: +30 2105401500
Maltese: Τηλ: +30 2105401500
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DEJTA TINQARA MILL-BNIEDEM PC:
English: - The active substance is sildenafil.
Maltese: - Is-sustanza attiva hija sildenafil.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 December 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta‘ l-ewwel awtorizzazzjoni: 10 Diċembru 2009
English: In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, 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-popolazjonijiet tal-istudji, kien osservat tnaqqis addizzjonali medju tal-pressjoni meta kienu mimdudin ta' 7/7 mmHg, 9/5 mmHg u 8/4 mmHg rispettivament u tnaqqis addizzjonali medju ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg.
English: Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Maltese: Sildenafil huwa inibitur potenti u selettiv ta' cGMP specific fosfodiesterażi tat-tip 5 speċifika għascGMP (PDE5) fil-corpus cavernosum, fejn PDE5 huwa responsabbli għad-degradazzjoni ta' cGMP. Sildenafil għandu sit periferali ta' azzjoni fuq erezzjonijiet.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Maltese: Informazzjoni mhux klinika ma wriet ebda riskju speċjali għan-nies bażata fuq studji konvenzjonali ta' sigurtà farmakoloġika, tossisità ta' doża ripetuta, ġenotossiċità, potenzjal karċinoġeniku, u ħsara fissistema riproduttiva u żvilupp.
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Maltese: Hemm selettività ta' 10-darbiet aktar fuq PDE6 li huwa involut fir-rotta tal-fototransduzzjoni fir-retina.
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Maltese: Fi tliet studji speċifiċi għal interazzjoni bejn żewġ prodotti mediċinali, alpha blocker doxazosin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg u 100 mg) ġew amministrati fl-istess ħin lil pazjenti bi tkabbir benin tal-prostata (BPH), stabilizzati fuq kura ta' doxazosin.
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-metabolit għandu profil selettiv ta' fosfodiesterażi simili għal sildenafil u potenza in vitro għal PDE5 bejn wieħed u ieħor 50% ta' dik tal-mediċina mhux mibdula.
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Maltese: Is-sigurta' ta' Sildenafil Actavis hija bbażata fuq 9,570 pazjenti f'74 studji kliniċi double-blind kkontrollati bi plaċebo.
English: The maximum recommended dose is 100 mg.
Maltese: Id-doża massima rakkomandata hija 100 mg.
English: This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
Maltese: Dan jista' jseħħ l-aktar sa 4 sigħat wara li tittieħed iddoża ta' sildenafil (ara sezzjonijiet 4.2 u 4.4).
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Maltese: Fi provi kliniċi sildenafil ġie amministrat lil aktar minn-8000 pazjent ta' età 19-87 sena.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Maltese: Għalkemm ma sarux studji speċifiċi ta' interazzjoni għal prodotti mediċinali kollha, analiżi farmakokinetiċi tal-popolazzjoni ma juru l-ebda effett ta' trattament konkomitanti fuq ilfarmakokinetiċi ta' sildenafil meta miġbura fi gruppi bħala inibituri ta' CYP2C9 (bħal tolbutamide, warfarin, phenytoin), inibituri ta' CYP2D6 (bħal selective serotonin reuptake inhibitors, antidipressanti triċikliċi), thiazide u dijuretiċi relatati, dijuretiċi loop u potassium-sparing, inibituri talenżima li tikkonverti l-anġotensina, channel blockers tal-kalċju, antagonisti beta-adrenoreceptor jew indutturi tal-metaboliżmu CYP450 ( bħal rifampicin, barbiturati).
English: Sildenafil Actavis contains lactose
Maltese: Sildenafil Actavis fih lactose
English: System Organ
Maltese: Organu
English: In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Maltese: F'voluntiera b'saħħithom li ħadu sildenafil (100 mg doża waħda), anqas minn 0.0002% (medja 188 ng) tad-doża amministrata kienet preżenti fl-isperma 90 minuta wara d-doża.
English: Sildenafil Actavis contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Sildenafil Actavis fiha is-sustanza attiva sildenafil li tagħmel ma' grupp ta' mediċinali msejjħa inibituri tal-fosfodiesterażi tip 5(PDE5).
English: Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
Maltese: Sildenafil (50 mg) ma saħħaħx iż-żieda fil-ħin tal-fsada kaġunat mill-acetyl salicylic acid (150 mg).
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)).
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi ta' importanza medika, li seħħew fl-istudji kliniċi b'inċidenza iktar minn bil-plaċebo, huma mniżżla skond il-klassi tal-organi u l-frekwenzi (komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000)).
English: Sildenafil is an oral therapy for erectile dysfunction.
Maltese: Sildenafil huwa terapija orali għal problema tal-erezzjoni tal-pene.
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Maltese: Cimetidine (800 mg), inibitur ta' ċitokromju P450 u inibitur ta' CYP3A4 mhux speċifiku, wassal għal żieda ta' 56% fil-konċentrazzjonijiet tal-plażma ta' sildenafil meta koamministrat ma' sildenafil (50 mg) f' voluntiera b'saħħithom.
English: Rare (³ 1/10000 and
Maltese: Rari (≥ 1/10000 and <1/1000)
English: The mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively, compared to age-matched volunteers with no renal impairment.
Maltese: Il-medja tal-AUC u Cmax tal-metabolit N-desmethyl żdiedu b'126% u 73% rispettivament, mqabbel ma' voluntiera tal-istess età li ma kellhomx ħsara fil-kliewi.
English: No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Maltese: Ma kienx hemm interazzjonijiet sinifikanti meta sildenafil (50 mg) kien ko-amministrat ma' tolbutamide (250 mg) jew warfarin (40 mg), li t-tnejn li huma jiġu metabolizzati minn CYP2C9.
English: Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Maltese: Studji bi plejtlets umani jindikaw li sildenafil isaħħaħ l-effett kontra l-aggregazzjoni ta' sodium nitroprusside in vitro.
English: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Maltese: Sildenafil (50 mg) ma saħħaħx l-effetti ipotensivi tal-alkoħol f'voluntiera b'saħħithom b'medja talogħla livelli ta' alkoħol fid-demm ta' 80 mg/dl.
English: Sildenafil Actavis 25 mg film-coated tablets EU/1/09/595/001
Maltese: Sildenafil Actaivs 25 mg pilloli miksija b'rita EU/1/09/595/001
English: Sildenafil Actavis 100 mg film-coated tablets EU/1/09/595/011
Maltese: Sildenafil Actavis 100 mg pilloli miksija b'rita EU/1/09/595/011
English: Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Maltese: Sildenafil huwa mnaddaf primarjament mill-iżo-enżimi mikrożomali CYP3A4 (rotta ewlenija) u CYP2C9 (rotta minuri) tal-fwied.
English: Sildenafil Actavis 50 mg film-coated tablets EU/1/09/595/006
Maltese: Sildenafil Actavis 50 mg pilloli miksija b'rita EU/1/09/595/006
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 il-website tal-Aġenzija Ewropea dwar ilmediċini: http://www.ema.europa.eu/.
English: The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Maltese: 3%), b'mard iskemiku tal-qalb (5.8%), iperlipidimja (19.8%), ħsara fis-sinsla tad-dahar (0.6%), dipressjoni (5.2%), b'resezzjoni transuretrali tal-prostata (3.7%), prostatektomija radikali (3.3%).
English: Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).
Maltese: L-użu flimkien ta' riociguat ma' inibituri ta' PDE5, inkluż sildenafil, huwa kontraindikat (ara sezzjoni 4.3).