FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil Mylan is a treatment for adult men with erectile dysfunction.
Maltese: Tadalafil Mylan huwa trattament għall-irġiel adulti b'disfunzjoni erettili.
English: Tadalafil Mylan 5 mg is available in blister packs containing 14, 28, 30, 56, 84 and 98 tablets.
Maltese: Tadalafil Mylan 5 mg hu disponibbli f'pakketti tal-folji li jkun fihom 14, 28, 30, 56, 84 u 98 pillola.
English: Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking tadalafil (86%, 83% and 72% for mild, moderate, and severe, respectively, as compared to 45%, 42% and 19% with placebo).
Maltese: Barra minn hekk, pazjenti b'disfunzjoni erettili fil-kategoriji kollha ta' severita' kellhom erezzjonijiet imtejbin meta ħadu tadalafil (86%, 83%, u 72% għal disfunzjoni ħafifa, moderata, u gravi, rispettivament, meta mqabbel ma' 45%, 42%, u 19% li ħadu l-plaċebo).
English: Tadalafil and other treatments for erectile dysfunction
Maltese: Tadalafil u trattamenti oħra għal disfunzjoni erettili
English: - if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
Maltese: - jekk inti qed tieħu xi forma ta' nitrate organiku jew donaturi ta' nitric oxide bħal amyl nitrite.
English: Transient amnesia
Maltese: Aċċessjonijiet Amnesija temporanja
English: Date of first authorisation: 21 November 2014 Date of latest renewal: 31 July 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 Novembru 2014
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksijin b'rita 28 pillola miksijin b'rita 30 pillola miksijin b'rita 56 pillola miksijin b'rita 84 pillola miksijin b'rita 98 pillola miksijin b'rita
English: Pack sizes of 2, 4, 8,12 and 24 tablets
Maltese: Daqsijiet tal-pakkett ta' 2, 4, 8, 12 u 24 pillola.
English: What Tadalafil Mylan contains - The active substance is tadalafil.
Maltese: X'fih Tadalafil Mylan - Is-sustanza attiva hi tadalafil.
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Maltese: Tadalafil huwa prinċipalment metabolizzat permezz ta' l-iżoforma ċitokromju P450 (CYP) 3A4.
English: Hepatic insufficiency
Maltese: Indeboliment Epatiku
English: The improvement in the total international prostate symptom score with tadalafil 5 mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 and -4.2 with placebo.
Maltese: It-titjib fil-total tal-punteġġ internazzjonali għas-sintomi tal-prostata b'tadalafil 5 mg fl-erba' studji kienu -4.8, -5.6 u -6.3 meta mqabbel ma' -2.2, -3.6, -3.8 u -4.2 bi plaċebo.
English: Alcohol concentrations (mean maximum blood concentration 0.08%) were not affected by co-administration with tadalafil (10 mg or 20 mg).
Maltese: Konċentrazzjonijiet ta' l-alkoħol (medja massima tal-konċentrazzjoni fid-demm 0.08%) ma kinux affettwati mit-teħid ta' tadalafil magħhom (10 mg jew 20 mg).
English: Tadalafil at doses of 2 to 100 mg has been evaluated in 16 clinical studies involving 3250 patients, including patients with erectile dysfunction of various severities (mild, moderate, severe), etiologies, ages (range 21-86 years), and ethnicities.
Maltese: Tadalafil f'dożi ta' 2 sa 100 mg kien evalwat f'16-il studju kliniku li involva aktar minn 3250 pazjent, inklużi pazjenti b'disfunzjoni erettili ta' gradi varji (ħafif, moderat, gravi), etjoloġiji varji, etajiet varji (skala 21-86 sena), u etniċitajiet varji.
English: - rifampicin, erythromycin, clarithromycin or itraconazole.
Maltese: - rifampicin, erythromycin , clarithromycin jew itraconazole - trattamenti oħra għad-disfunzjoni erettili.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40% alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed.
Maltese: Tadalafil (20 mg) ma żiedx il-medja tat-tnaqqis ta' pressjoni tad-demm prodotta mill-alkoħol (0.7 g/kg jew madwar 180 ml ta' 40% alkoħol [vodka] f'irġiel ta' 80 kg) iżda f'xiindividwi, kienu osservati sturdament dovut għat-tibdil fil-pożizzjoni tal-persuna u pressjoni baxxa ortostatika.
English: A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Maltese: Inibitur selettiv ta' CYP3A4, ketoconazole (200 mg kuljum), żied l-esponiment għal tadalafil (10-mg) (AUC) b'darbtejn u Cmax bi 15%, relattivament għall-AUC u għal valuri ta' Cmax għal tadalafil biss.
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, u CYP2D6, żied l-esponiment għal tadalafil (20-mg) (AUC) b'darbtejn bl-ebda tibdil f'Cmax.
English: Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 and 24 tablets.
Maltese: Tadalafil Mylan 20 mg hu disponibbli f'pakketti tal-folji li jkun fihom 2, 4, 8, 12 u 24 pillola.
English: How to store Tadalafil Mylan
Maltese: Tiħux Tadalafil Mylan
English: In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on tadalafil 5 mg, 50% on tadalafil 2.5 mg as compared to 31 and 37% with placebo.
Maltese: Fiż-żewġ studji primarji ta' effikaċja fuq popolazzjonijiet ġenerali,il-proporzjon ta' tentattivi ta' kopulazzjoni b'suċċess għal kull pazjent kienu medja ta' 57 u 67% għal dawk fuq tadalafil 5 mg, 50% għal dawk fuq tadalafil 2.5 mg meta mqabbla ma' 31 u 37% li ħadu plaċebo.
English: Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets.
Maltese: Tadalafil Mylan 2.5 mg hu disponibbli f'pakketti tal-folji li jkun fihom 28 u 56 pillola.
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-AUC għal tadalafil waħdu (10 mg).
English: Frequency convention: 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Frekwenza: 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), Rari ħafna ( <1 /10,000) u mhux magħruf (ma tistax tittieħed stima middata disponibbli)
English: The mean persubject proportion of successful sexual intercourse attempts was 71.9% with tadalafil 5 mg compared to 48.3% with placebo.
Maltese: Il-proporzjon ta' tentattivi ta' kopulazzjoni sesswali b'suċċess għal kull pazjent kien medja ta' 71.9% għall-pazjenti b'tadalafil 5 mg meta mqabbel ma' 48.3% għall-pazjenti fuq plaċebo.
English: The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Maltese: Il-volum medju tad-distribuzzjoni huwa madwar 63l , li jindika li tadalafil jiġi distribwit fit-tessuti.
English: The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil patients compared to 52% for patients on placebo.
Maltese: Il-proporzjon ta' tentattivi ta' kopulazzjoni sesswali b'suċċess għal kull pazjent kien medja ta' 68% għall-pazjenti fuq tadalafil meta mqabbel ma' 52% għall-pazjenti fuq plaċebo.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, ta' defiċjenza ta' lactase totali jew ta' malassorbiment ta'glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: It may be taken at least 30 minutes prior to sexual activity.
Maltese: Tista' tieħu tadalafil mill-inqas 30 minuta qabel l-attivita' sesswali.
English: In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo.
Maltese: Fl-istudju f'pazjenti li kellhom disfunzjoni erettili sekondarja għad-dijabete, il-proporzjon ta' tentattivi ta' suċċess għal kull pazjent kienu medja ta' 41 u 46% għal dawk fuq tadalafil 5 mg u 2.5 mg rispettivament, meta mqabbel ma' 28% li ħadu plaċebo.
English: Priapism, Penile haemorrhage, Haematospermia
Maltese: Prijapiżmu, Emorraġija tal-pene, Ematospermija
English: Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
Maltese: Kisja b'rita: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
English: The randomised, double-blind, placebo-controlled, parallel, 3-arm study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid therapy.
Maltese: L-istudju ta' tadalafil, bi 3 fergħat, parallel, magħmul b'mod arbitrarju, double-blind u kkontrollat bi plaċebo sar f'331 tifel b'etajiet minn 7-14-il sena b'DMD li fl-istess ħin kienu qed jirċievu t-terapija bil-kortikosterojdi.
English: Tadalafil Mylan 20 mg tablets tadalafil
Maltese: Tadalafil Mylan 20mg pilloli tadalafil
English: Excipient with known effect: Each film-coated tablet contains 118.96 mg of lactose.
Maltese: Kull pillola miksija b'rita fiha 118.96 mg ta' lactose.
English: Tadalafil may still be effective up to 36 hours after taking the tablet.
Maltese: Tadalafil jista' jibqa' effettiv sa 36 siegħa wara li tieħu l-pillola.
English: Κύπρος (Cyprus)
Maltese: България (Bulgaria)
English: Tadalafil Mylan 10 mg is available in blister packs containing 4, 12 and 24 tablets.
Maltese: Tadalafil Mylan 10 mg hu disponibbli f'pakketti tal-folji li jkun fihom 4, 12 u 24 pillola.
English: At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Maltese: F'konċentrazzjonijiet terapewtiċi, 94% ta' tadalafil fil-plażma jkun marbut mal-proteini.
English: Cytochrome P450 metabolised medicinal products
Maltese: Prodotti mediċinali metabolizzati b'Cytochrome P450
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 is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Maltese: Tadalafil huwa wkoll >1 0,000 darba aktar potenti għal PDE5 milli għal PDE7 permezz ta' PDE10.
English: Excipient with known effect: Each film-coated tablet contains 29.74 mg of lactose.
Maltese: Kull pillola miksija b'rita fiha 29.74 mg lactose.
English: Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated.
Maltese: Pazjenti li ma jkunux kapaċi jittolleraw id-doża ta' tadalafil 5 mg għall-kura tal-iperplażja beninna talprostata għandhom jikkunsidraw terapija alternattiva peress li l-effikaċja ta' tadalafil 2.5 mg ma ġietx murija fl-iperplażja beninna tal-prostata.
English: Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Maltese: Wieħed għandu joqgħod attent meta jikteb riċetta għal tadalafil lill-pazjenti li qed jużaw inibituri qawwijin ta' CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, u erythromycin) għaliex kien osservat esponiment akbar għal tadalafil (AUC) meta l-prodotti mediċinali jingħataw flimkien (Ara sezzjoni 4.5).
English: Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Maltese: Tadalafil (10 mg 20 mg) ma kellu l-ebda effett klinikament sinifikanti fuq l-espożizzjoni (AUC) għal S-warfarin jew R-warfarin (substrat ta' CYP2C9 ), u tadalafil lanqas ma affettwa tibdil fil-ħin talprotrombin indott mill-warfarin.
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: This will be given as a 2.5 mg tablet.
Maltese: Din tingħata bħala pillola ta' 2.5 mg.
English: Tadalafil Mylan 10 mg tablets tadalafil
Maltese: Tadalafil Mylan 10mg pilloli tadalafil
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Maltese: Leffett ta' l-alkoħol fuq ilfunzjoni konjitiva ma żdiedx bit-tadalafil (10 mg).
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Maltese: L-informazzjoni klinika dwar is-sigurta' ta' tadalafil f'pazjenti b'insuffiċjenza epatika gravi (Child-Pugh Klassi C) hija limitata.
English: Tadalafil Mylan 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Maltese: Tadalafil Mylan 10 mg u 20 mg huwa intenzjonat għall-użu qabel attività sesswali prevista u mhux irrakkomandat għall-użu kontinwu ta' kuljum.
English: Excipient with known effect: Each film-coated tablet contains 59.48 mg of lactose.
Maltese: Kull pillola miksija b'rita fiha 59.48 mg ta' lactose.
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 (Child-Pugh Klassi A u B) huwa komparabbli ma' l-espożizzjoni f'individwi b'saħħithom meta tingħata doża ta' 10 mg.
English: Seizures
Maltese: Viżjoni
English: PVC/PE/PVdC-Alu blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-Alu PVC/PE/PVdC.
English: Tadalafil Mylan 5 mg tablets tadalafil
Maltese: Tadalafil Mylan 5mg pilloli tadalafil
English: You may take tadalafil at least 30 minutes before sexual activity.
Maltese: Tista' tittieħed għall-inqas 30 minuta qabel l-attivita' sesswali.
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Maltese: Fl-istudji tal-farmakoloġija klinika fejn intużat doża waħda ta' tadalafil (5 sa 20 mg), l-esponiment għal tadalafil (AUC) kien madwar id-doppju f'individwi b'indeboliment ħafif fil-kliewi (tneħħija talkrejatinina 51 sa 80 ml/min) jew moderat (tneħħija tal-krejatinina 31 sa 50 ml/min) u f'individwi fuq id-dijaliżi bi stat terminali tal-funzjoni tal-kliewi.
English: Tadalafil Mylan 2.5 mg tablets tadalafil
Maltese: Tadalafil Mylan 2.5 mg pilloli tadalafil
English: Talk to your doctor for further information.
Maltese: Tkellem mat-tabib tiegħek għal aktar informazzjoni.
English: Anti-hypertensives (including calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Maltese: It-teħid flimkien ta' doxazin (4 u 8 mg kuljum) u tadalafil (doża ta' 5 mg kuljum u doża waħda ta' 20 mg) iżid b'mod sinifikanti l-effett ta' tnaqqis fil-pressjoni tad-demm ta' dan l-imblokkatur tarreċetturi alpha.
English: Tadalafil Mylan contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Tadalafil Mylan fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Syncope,
Maltese: (li tinkludi avvenimenti emorraġiċi), Sinkope,
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, 44pl aċebo) 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: EU/1/14/961/002 EU/1/14/961/003 EU/1/14/961/004 EU/1/14/961/005 EU/1/14/961/006
Maltese: EU/1/14/961/002 EU/1/14/961/003 EU/1/14/961/004
English: Aspirin 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: EU/1/14/961/001 EU/1/14/961/010 EU/1/14/961/011
Maltese: EU/1/14/961/001 EU/1/14/961/010
English: Tadalafil Mylan contains lactose.
Maltese: Tadalafil Mylan fih l-lactose.
English: It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing prostatectomy.
Maltese: Mhux magħruf jekk tadalafil huwiex effettiv f'pazjenti li għaddew minn kirurġija fil-pelvis jew prostatettomija radikali fejn in-nervituri ma' ġewx salvati.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4 enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Maltese: Tadalafil huwa >1 0,000 darba aktar potenti għal PDE5 milli għalPDE1, PDE2 u PDE4, li huma enżimi li jinsabu fil-qalb, fil-moħħ, fil-vini u l-arterji, fil-fwied u f'organi oħra.
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: 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: Film-coat:
Maltese: Tel:
English: Tadalafil Mylan contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Maltese: Tadalafil Mylan għandu s-sustanza attiva tadalafil li jagħmel parti minn grupp ta' mediċini msejħa inibituri talphosphodiesterase tip 5.
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendroflumethiazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Maltese: Klassijiet ewlenin ta' prodotti mediċinali li jintużaw kontra l-pressjoni għolja kienu studjati, inklużi l-calcium channel blockers (amlodipine), inibituri ta' lenżimi li jbiddlu l-angiotensin (ACE) (enalapril), dawk li jimblukkaw ir-riċetturi beta-adrenerġiċi (metoprolol), id-djuretiċi ta't-tip thiazide (bendrofluazide), u dawk li jimblukkaw ir-riċetturi ta' langiotensin II (tipi u dożi varji, waħedhom jew flimkien ma' thiazides, dawk li jimblukkaw il-passaġġi tal-kalċjum, blokkaturi-beta, u/jew blokkaturi-alpha).
English: Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Maltese: Dożaġġ ta' darba kuljum ta' tadalafil m'huwiex rakkomandat f'pazjenti b'indeboliment renali sever (ara sezzjoni 4.4 u 5.2).
English: The adverse reactions reported were transient, and generally mild or moderate.
Maltese: Irreazzjonijiet avversi li ġew irrapportati kienu temporanji u ħafna drabi ħfief jew moderati.
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: 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 (ara sezzjoni 4.5).
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' 48 ġimgħa fejn il-pazjenti, b'mod arbitrarju, ngħataw kuljum tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, jew plaċebo.
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled clinical trials (comprising a total of 8022 patients on tadalafil 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 tadalafil u 4422 pazjent fuq plaċebo) għallkura tad-disfunjoni eretilli kemm meta tadalafil 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: Hypersensitivity reactions Angioedema
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Each tablet contains 20 mg tadalafil.
Maltese: Kull pillola fiha 20 mg tadalafil.
English: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Maltese: Każijiet kardjovaskulari serji, fosthom infart mijokardijaku, mewt kardijaku għal għarrieda, angina pectoris instabbli, arritmija ventrikulari, puplesija, attakki iskemiċi transitorji, uġigħ fis-sider, palpitazzjonijiet u takikardija, ġew irrapportati jew wara t-tqegħid fis-suq u/jew fi provi kliniċi.
English: Nervous system disorders Headache
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras
English: Tadalafil Mylan contains sodium
Maltese: Tadalafil Mylan fih is-sodium
English: Tadalafil Mylan 10 mg film-coated tablets Tadalafil Mylan 20 mg film-coated tablets
Maltese: Tadalafil Mylan 10 mg pilloli miksijin b'rita Tadalafil Mylan 20 mg pilloli miksijin b'rita