FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Maltese: Tadalafil (10 u 20 mg) ma żiedx iż-żieda fil-ħin ta' fsada ikkawżata minn acetyl salicylic acid.
English: There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
Maltese: L-informazzjoni klinika dwar is-sigurta' ta' CIALIS f'pazjenti b'insuffiċjenza epatika gravi (Child-Pugh Klassi C) hija limitata.
English: Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
Maltese: Kisja b'rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar (E172), iron oxide aħmar (172), talc.
English: In haemodialysis patients, Cmax was 41 % higher than that observed in healthy subjects.
Maltese: Fil-pazjenti fuq l-emodjaliżi, Cmax kien 41% ogħla minn dak osservat f'individwi b'saħħithom.
English: Tadalafil at doses of 2.5, 5, and 10 mg taken once a day was initially evaluated in 3 clinical studies involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Maltese: Tadalafil f'dożi ta' 2.5, 5, u 10 mg meħuda darba kuljum kien għall-ewwel evalwat f'3 studji kliniċi li fihom ħadu sehem 853 pazjent,ta' etajiet (marġni ta' 21-82 sena) u razez differenti, b'disfunzjoni erettili li kellhom gradi ta' severità (ħafif, moderat, gravi) u etjoloġiji varji.
English: You may take a CIALIS tablet at least 30 minutes before sexual activity.
Maltese: Tista' tieħu pillola ta' CIALIS mill-inqas 30 minuta qabel l-attivita' sesswali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/237/001
Maltese: FIS-SUQ EU/1/02/237/001
English: Respiratory, thoracic and mediastinal disorders Nasal congestion
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08.
Maltese: Mediċini uroloġiċi, Mediċini użati għad-disfunzjoni erettili, Kodiċi ATC:
English: PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta'PDE5, bħal CIALIS,iżidu l-effetti ipotensivi ta' din il-mediċina.
English: When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum.
Maltese: Meta l-istimolu sesswali jikkawża ħruġ lokali ta'nitric oxide, linibizzjoni ta' PDE5 permezz ta' tadalafil tipproduċi livelli ogħla ta' cGMP fil-corpus cavernosum.
English: Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Maltese: tadalafil m'huwiex rakkomandat f'pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.4 u 5.2).
English: - urinary symptoms associated with a common condition called benign prostatic hyperplasia.
Maltese: - sintomi urinarju assoċjati ma' kundizzjoni komuni li tissejjaħ iperplażja beninna tal-prostata.
English: CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Maltese: CIALIS 10 mg u 20 mg huwa intenzjonat għall-użu qabel attività sesswali prevista u mhux irrakkomandat għall-użu kontinwu ta' kuljum.
English: CIALIS was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia.
Maltese: CIALIS ġie studjat f'4 studji kliniċi li damu 12-il ġimgħa u li fihom ħadu sehem 'il fuq minn 1500 pazjent b'sinjali u sintomi ta' iperplażja beninna tal-prostata.
English: The study included a 48-week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily.
Maltese: L-istudju kien jinkludi perijodu double-blind ta' 84 ġimgħa fejn il-pazjenti, b'mod arbitrarju, ngħataw kuljum tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, jew plaċebo.
English: Each coated tablet contains 170 mg lactose (as monohydrate).
Maltese: Kull pillola miksija fiha 170 mg lactose (bħala monohydrate).
English: Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.
Maltese: Indutturi oħrajn ta' CYP3A4 bħall-phenobarbital, phenytoin u carbamazepine, jistgħu wkoll inaqqsu il konċentrazzjonijiet ta' tadalafil fil-plażma.
English: CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Maltese: CIALIS għandu s-sustanza attiva tadalafil li jagħmel parti minn grupp ta' mediċini msejħa inibituri tal phosphodiesterase tip 5.
English: Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.
Maltese: Tadalafil wera titjib statistikament sinifikanti fil funzjoni erettili u fl-abilita' li jkun hemm kopulazzjoni sesswali b'suċċess sa 36 siegħa wara li tittieħed id-doża, kif ukoll fl-abilita' tal-pazjenti li jkollhom u jżommu erezzjoni għal kopulazzjoni b'suċċess meta mqabbel ma' plaċebo wara 16 minuta mit-teħid tad-doża.
English: In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Maltese: Fi studju li dam 12-il ġimgħa u li ġie magħmul f'186 pazjent (142 tadalafil, 44 plaċebo) b'disfunzjoni erettili kawża ta' trawma tan-nerv li jgħaddi minn ġos-sinsla, tadalafil b'mod sinifikanti tejjeb ilfunzjoni erettili li wassal għal medja f'kull pazjent ta' proporzjon ta' tentattivi ta' suċċess f'dawk ikkurati b'tadalfil 10 mg jew 20 mg (doża flessibbli, meta jkun hemm il-bżonn) ta' 48% meta mqabbel ma' 17% bi plaċebo.
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Maltese: L-esponiment għal tadalafil (AUC) f'individwi b'insuffiċjenza ħafifa u moderata tal-fwied (ChildPugh Klassi A u B) huwa komparabbli ma' l-espożizzjoni f'individwi b'saħħithom meta tingħata doża ta' 10 mg.
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).
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: INFORMATION IN BRAILLE cialis 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cialis 10 mg
English: CIALIS 20 mg film-coated tablets
Maltese: CIALIS 20 mg pilloli tadalafil
English: Aluminium/PVC blisters in cartons of 28 film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC f‘kartuniet ta' 28 pillola miksijin b'rita.
English: Decreased or sudden hearing loss
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: - leukaemia (cancer of the blood cells).
Maltese: Mediċini tal-pressjoni (inkluż calcium channel blockers)
English: Each tablet contains 5 mg of tadalafil.
Maltese: Kull pillola fiha 5 mg tadalafil.
English: Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Maltese: Effikaċja klinika u sigurtà Tadalafil li ngħata lill-individwi b'saħħithom, meta mqabbel ma' plaċebo, ma pproduċa l-ebda differenza sinifikanti fil-pressjoni sistolika u dijastolika meħuda meta l-individwu kien mimdud fuq dahru (medja massima ta' tnaqqis ta' 1.6/0.8 mm Hg, rispettivament), fil-pressjoni sistolika u dijastolika meħuda meta l-individwu kien bilwieqfa (medja massima ta' tnaqqis ta' 0.2/4.6 mm Hg, rispettivament), u l-ebda tibdil sinifikanti fir-rata tat-taħbit tal-qalb.
English: CIALIS contains lactose.
Maltese: CIALIS fih l-lactose.
English: INFORMATION IN BRAILLE cialis 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE cialis 5 mg
English: Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients.
Maltese: Dożi singli sa 500 mg ngħataw lill-individwi b'saħħithom, u dożi multipli sa 100 mg kuljum ingħataw lill-pazjenti.
English: General disorders and administration site conditions Chest pain1, Peripheral oedema, Fatigue
Maltese: Uġigħ fis-sider1, Edima periferali, Għeja
English: There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (ChildPugh Class C).
Maltese: L-informazzjoni klinika dwar is-sigurta' ta' CIALIS f'pazjenti b'insuffiċjenza gravi tal fwied (Child-Pugh Klassi C); hija limitata.
English: - The other ingredients are: Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Maltese: Qalba tal-pillola: lactose monohydrate (ara l-aħħar parti ta' sezzjoni 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
English: For once-a-day evaluation of tadalafil at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Maltese: Għall-evalwazzjoni ta' dożaġġ ta' darba kuljum b'tadalafil f'dożi ta' 2.5, 5, u 10 mg għall-ewwel kienu saru 3 studji kliniċi li fihom ħadu sehem 853 pazjent,ta' etajiet (marġni ta' 21-82 sena) u razez differenti, b'disfunzjoni erettili li kellhom gradi ta' severità (ħafif, moderat, gravi) u etjoloġiji varji.
English: Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61 % of the dose) and to a lesser extent in the urine (approximately 36 % of the dose).
Maltese: Tadalafil jitneħħa prinċipalment bħala metaboli mhux attivi, l-aktar fl-ippurgar (madwar 61% taddoża) u b'ammont inqas fl-awrina (madwar 36% tad-doża).
English: Aluminium/PVC blisters in cartons of 14, 28 or 84 film-coated tablets.
Maltese: Folji ta' l-aluminju/PVC f‘kartuniet ta' 14, 28 jew 84 pillola miksijin b'rita.
English: Cardiac disorders1
Maltese: Attakk ta' puplesija1
English: Less than 0.0005 % of the administered dose appeared in the semen of healthy subjects.
Maltese: Inqas minn 0.0005% tad-doża mogħtija dehret fis-semen ta' individwi b'saħħithom.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Maltese: Meta tadalafil 10 mg ingħata ma' theophylline (inibitur mhux selettiv tal-phosphodiesterase) fi studju ta' farmakoloġija klinika, ma kienx hemm interazzjoni farmakokinetika.
English: In patients who are taking alpha1 blockers, concomitant administration of CIALIS may lead to symptomatic hypotension in some patients (see section 4.5).
Maltese: F'pazjenti li qed jieħdu alpha1 blockers, l-amministrazzjoni konkomitanti ta' CIALIS jista' jwassal għal pressjoni baxxa sintomatika f'xi pazjenti (ara sezzjoni 4.5).
English: CIALIS 5 mg is used to treat adult men with: - erectile dysfunction.
Maltese: CIALIS 5 mg jintuża għall-kura fl-irġiel adult b': - disfunzjoni erettili.
English: However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is coadministered with 5-ARIs.
Maltese: Madankollu peress li ma sarx studju formali ta' interazzjoni bejn mediċina u oħra li jevalwa l-effetti ta' tadalafil u l-inibituri ta' 5-alpha reductase (5-ARIs), wieħed għandu joqgħod attent meta tadalafil jingħata flimkien ma' 5-ARIs.
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Maltese: Leffett ta' l-alkoħol fuq il-funzjoni konjitiva ma żdiedx bit-tadalafil (10 mg).
English: Absolute bioavailability of tadalafil following oral dosing has not been determined.
Maltese: Il-biodisponibilita' assoluta ta' tadalafil wara doża orali ma ġietx determinata.
English: Haematuria
Maltese: Viżjoni
English: The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects.
Maltese: It-tneħħija medja orali ta' tadalafil hija 2.5 l/siegħa u l-half-life medja hija ta' 17.5 sigħat f'individwi b'saħħithom.
English: This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5.
Maltese: Din issejba hija konsistenti ma' l-affinita' baxxa ta' tadalafil għal PDE6 meta mqabbel ma' PDE5.
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of CIALIS 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily.
Maltese: Saru tliet studji fl-irġiel biex ikun stmat l-effett potenzjali fuq l-ispermatoġenesi ta' CIALIS 10 mg (studju wieħed ta' 6 xhur) u 20 mg (studju wieħed ta' 6 xhur u studju wieħed ta' 9 xhur) mogħtija kuljum.
English: For oral once-a-day use.
Maltese: Għall-użu orali darba kuljum.
English: CIALIS 10 mg film-coated tablets
Maltese: CIALIS 10 mg pilloli tadalafil
English: Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Maltese: Tadalafil huwa > 10,000 darba aktar potenti għal PDE5 milli għal
English: Abdominal pain, Vomiting, Nausea, Gastro-oesophageal reflux
Maltese: Rimettar, Dardir, Mard ta' rifluss gastro-esofagali
English: For patients with severe renal impairment 10 mg is the maximum recommended dose.
Maltese: Għall-pazjenti b'indeboliment renali sever 10 mg hija d-doża massima rakkomandata.
English: In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67 % on CIALIS 5 mg, 50 % on CIALIS 2.5 mg as compared to 31 and 37 % with placebo.
Maltese: effikaċja fuq popolazzjonijiet ġenerali,il-proporzjon ta' tentattivi ta' kopulazzjoni b'suċċess għal kull pazjent kienu medja ta' 57 u 67% għal dawk fuq CIALIS 5 mg, 50% għal dawk fuq CIALIS
English: Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections 4.
Maltese: Dożaġġ ta' darba kuljum ta' 2.5 jew 5 mg tadalafil għall-kura kemm tad-disfunzjoni erettili u kemm tal-iperplażja beninna tal-prostata m'huwiex rakkomandat f'pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.4 u 5.2).
English: Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).
Maltese: Żewġ studji kliniċi sussegwenti jissuġġerixxu li dan l-effett mhuwiex probabbli fil-bnedmin, għalkemm ġie nnutat tnaqqis fil-konċentrazzjoni ta' sperma f'xi rġiel (ara sezzjonijiet 5.1 u 5.3).
English: The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.
Maltese: Il-manteniment tal-effett kien evalwat f'estensjoni open label ta' wieħed mill-istudji li wera li t-titjib fit-total tal-punteġġ internazzjonali għas-sintomi tal-prostata li deher fit-12-il ġimgħa kien mantnut sa sena addizzjonali ta' kura b'CIALIS 5 mg.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Each tablet contains 20 mg of tadalafil.
Maltese: Kull pillola fiha 20 mg ta' tadalafil.
English: Light yellow and almond shaped tablets, marked "C 10" on one side.
Maltese: Pilloli sofor ċari u għandhom forma ta' lewża, immarkati "C 10" fuq naħa waħda.
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebocontrolled clinical trials (comprising a total of 8022 patients on CIALIS and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Maltese: It-tabella hawn taħt tniżżel ir-reazzjonijiet avversi osservati minn rapurtaġġ spontanju u minn studji kliniċi kkontrollati bil-plaċebo (b'total ta' 8022 pazjent fuq CIALIS u 4422 pazjent fuq plaċebo) għallkura tad-disfunjoni eretilli kemm meta CIALIS jittieħed meta jkun hemm il-bżonn u kemm f'dożaġġ ta' darba kuljum u għall-iperplażja beninna tal-prostata f'dożaġġ ta' darba kuljum.
English: In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives.
Maltese: Fi studju ieħor ta' farmakoloġija klinika, kien studjat tadalafil (20 mg) flimkien ma' sa 4 klassijiet ta' mediċini li jintużaw kontra lpressjoni għolja.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with CIALIS 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Maltese: It-titjib fil-kamp tal-funzjoni erettili tal-indiċi internazzjonali tal-funzjoni erettili u t-total tal-punteġġ internazzjonali għas-sintomi tal prostata f'dan l-istudju kienu ta' 6.5 u -6.1 b'CIALIS 5 mg meta mqabbel ma' 1.8 u -3.8 bi plaċebo,
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Maltese: Fi klieb li ngħataw tadalafil kuljum għal 6 sa 12-il xahar f'dożi ta' 25 mg/kg/jum (li jirriżulta f'esponiment mill-inqas 3 darbiet akbar [skala 3.7 - 18.6] milli jidher fil-bnedmin li ngħataw doża waħda ta' 20 mg) u aktar, kien hemm rigressjoni tal-epitelju tubulari seminiferu li rriżulta fi tnaqqis tal-ispermatoġenesi f'xi klieb.
English: - multiple myeloma (cancer of the bone marrow).
Maltese: - majeloma multipla (kanċer tal-mudullun). - lewkimja (kanċer taċ-ċelloli tad-demm).
English: Package leaflet: Information for the user
Maltese: Kontenut tal-pakket u informazzjoni oħra
English: Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
Maltese: Tadalfil 10 u 20 mg huwa intenzjonat għall-użu qabel attività sesswali prevista u mhux irrakkomandat għall-użu kontinwu ta' kuljum.
English: What CIALIS looks like and contents of the pack CIALIS 5 mg is a light yellow film-coated tablet in the shape of an almond and has "C 5" marked on one side.
Maltese: Kif jidher CIALIS u l-kontenut tal-pakkett CIALIS 5 mg hija pillola safra ċara miksija b'rita f'forma ta' lewża, u mmarkata b'"C 5" fuq naħa waħda.
English: Each tablet contains 2.5 mg of tadalafil.
Maltese: Kull pillola fiha 2.5 mg ta' tadalafil.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intoleranza għall-galactose, ta' nuqqas ta' Lapp lactase jew ta' malassorbiment ta'glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali. 4.5
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 għallMediċini: http://www.ema.europa.eu/
English: What CIALIS looks like and contents of the pack CIALIS 10 mg is a light yellow film-coated tablet in the shape of an almond and has "C 10" marked on one side.
Maltese: Kif jidher CIALIS u l-kontenut tal-pakkett CIALIS 10 mg hija pillola safra ċara miksija b'rita, f'forma ta' lewża u huma mmarkata b'"C 10" fuq naħa waħda.
English: Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Maltese: Ritonavir, inibitur ta' lenżima protease (200 mg darbtejn kuljum), li huwa inibitur ta' CYP3A4, CYP2C9, CYP2C19,
English: CIALIS is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Maltese: CIALIS huwa kontraindikat f'pazjenti li tilfu d-dawl f'għajn waħda minħabba newropatija ottika iskemika anterjuri li m'hijiex arteritika (NAION), indipendetement mill-fatt jekk dan l-episodju kienx marbut jew le ma' użu preċedenti ta' inibitur ta' PDE5 (ara sezzjoni 4.4).
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Maltese: Tadalafil huwa > 10,000 darba aktar potenti għal PDE5 milli għal PDE3, li hija enżima li tinsab fil-qalb u fil-vini u l-arterji.
English: NAME OF THE MEDICINAL PRODUCT CIALIS 2.5 mg tablets tadalafil
Maltese: CIALIS 2.5 mg pilloli tadalafil
English: A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88 %, relative to the AUC values for tadalafil alone (10 mg).
Maltese: Rifampicin, induttur ta' CYP3A4, naqqas l-AUC ta' tadalafil bi 88%, relattivament għall-valuri tal
English: Antidiabetic medicinal products Specific interaction studies with antidiabetic medicinal products were not conducted.
Maltese: Ma sarux studji ta' interazzjonijiet speċifiċi ma' mediċini antidijabetiċi.
English: CIALIS 20 mg film-coated tablets Each tablet contains 20 mg tadalafil.
Maltese: CIALIS 20 mg pilloli miksijin b'rita Kull pillola fiha 20 mg tadalafil.
English: CIALIS 5 mg film-coated tablets Tadalafil
Maltese: CIALIS 5 mg pilloli tadalafil
English: CIALIS does not treat prostate cancer.
Maltese: CIALIS u trattamenti oħra għal disfunzjoni erettili
English: The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Maltese: It-teħid flimkien ta' inibituri ta' PDE5, inkluż tadalafil, ma' stimulaturi ta' guanylate cyclase, bħal riociguat, huwa kontraindikat għax hemm il-possibbiltà li dan iwassal għal ipotensjoni sintomatika
English: In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Maltese: F'tnejn minn dawn l-istudji ġew osservati tnaqqis fl-għadd u fil-konċentrazzjoni ta' sperma relatati ma' kura b'tadalafil ta' relevanza klinika improbabbli.
English: This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Maltese: PDE3 hija enżima li hija involuta fil-kontrattilita' kardijaka.