FrancophonIA/ELRC3.0 huggingface dataset:
English: Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88 % and Cmax by 46 %, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Maltese: Rifampicin (600 mg kuljum), stimulatur ta' ta' CYP3A4, naqqas l-AUC ta' tadalafil bi 88 % u s- Cmax b'46 % relattivament għall-valuri tal- AUC u s- Cmax għal tadalafil waħdu (10 mg).
English: Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Maltese: Tadalafil (10 mg 20 mg) ma kabbarx iż-żieda fil-ħin ta' fsada kkawżat minn acetyl salicylic acid.
English: Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15 %, relative to the AUC and Cmax values for tadalafil alone.
Maltese: Ketoconazole (200 mg kuljum), żied l-espożizzjoni (AUC) ta' doża waħda ta'tadalafil (10 mg) b'darbtejn u Cmax bi 15%, relattivament għall-AUC u għal valuri ta' Cmax għal tadalafil waħdu.
English: These effects are unlikely to lead to a lack of fertility.
Maltese: Mhuwiex probabbli li dawn l-effetti jwasslu għal xi nuqqas fil fertilità.
English: The efficacy of tadalafil in patients already on bosentan therapy has not been conclusively demonstrated (see sections 4.5 and 5.1).
Maltese: L-effikaċja ta' tadalafil f'pazjenti li diġà qegħdin fuq terapija bil-bosentan ma ġietx murija b'mod konklużiv (ara sezzjonijiet 4.5 u 5.1).
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) ta' Swarfarin jew R-warfarin (sustrat ta' CYP2C9 ), u tadalafil lanqas ma affettwa tibdil fil-ħin tal protrombin kkawżat mill-warfarin.
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 with erectile dysfunction.
Maltese: Dożi singli sa 500 mg ngħataw lill-individwi f'saħħithom, u dożi multipli sa 100 mg kuljum ingħataw lill-pazjenti b'disfunzjoni erettili.
English: Population pharmacokinetics
Maltese: Farmakokinetika ta' popolazzjoni
English: Improvements compared to placebo were observed with tadalafil 40 mg in the EuroQol (EQ-5D) US and UK index scores comprising mobility, self-care, usual activities, pain/discomfort, anxiety/depression components, and in the visual analogue scale (VAS).
Maltese: Meta mqabbel ma' plaċebo, ġie osservat titjib b'tadalafil 40 mg fil-valuri tal-indiċi EuroQol (EQ-5D) tal-Istati Uniti u tar-Renju Unit, li jinkludu mobilità, kura tiegħek innifsek, attivitajiet normali,
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 > 10,000 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: Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations within the pulmonary vascular smooth muscle.
Maltese: L-ipertensjoni arterjali pulmonarja hija assoċjata mat-tnaqqis fl-ammont ta' nitric oxide iġġenerat mill-endotelju vaskulari li jwassal għal tnaqqis fil-konċentrazzjonijiet ta' cGMP fil-muskolu involontarju vaskulari tal-pulmun.
English: The incidence of clinical worsening by week 16 in patients treated with tadalafil 40 mg (5 %; 4 of 79 patients) was less than placebo (16 %; 13 of 82 patients).
Maltese: 16-il ġimgħa marru klinikament agħar kienet inqas f'dawk ikkurati b'tadalafil 40 mg (5%; 4 minn 79 pazjent) milli bil-plaċebo (16%; 13 minn 82 pazjent).
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Maltese: Leffett tal-alkoħol fuq il-funzjoni konjitiva ma żdiedx bit-tadalafil (10 mg).
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.
Maltese: Uroloġikali, mediċini użati għad-disfunzjoni erettili, Kodiċi ATC:
English: ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Maltese: ADCIRCA huwa indikat fl-adulti għall-kura ta' ipertensjoni arterjali pulmonarja (PAH - pulmonary arterial hypertension) ikklassifikata bħala klassi II u III ta' funzjonalità skont il-WHO, biex titjieb ilkapaċità ta' eżerċizzju (ara sezzjoni 5.1).
English: Use with CYP3A4 inducers or inhibitors
Maltese: L-użu ma' stimulaturi jew inibituri ta' CYP3A4
English: Prostacyclin and its analogues
Maltese: Prostacyclin u l-analogi tiegħu
English: The mean volume of distribution is approximately 77 l at steady state, indicating that tadalafil is distributed into tissues.
Maltese: Il-volum medju tad-distribuzzjoni huwa madwar 77 l fl-istat fiss, li jindika li tadalafil jiġi distribwit fit-tessuti.
English: - sudden loss of vision (rarely reported).
Maltese: - telf tal-vista f'daqqa waħda (irrappurtata b'mod rari).
English: Urticaria5, Hyperhydrosis (sweating)5
Maltese: Urtikarja5, Iperidrosi (ħafna għaraq)5
English: Dyspepsia (including abdominal pain/discomfort3)
Maltese: Dardir, Dispepsja (li tinkludi uġigħ/dwejjaq addominali3)
English: In clinical pharmacology studies, the potential for tadalafil (10 and 20 mg) to augment the hypotensive effects of antihypertensive medicinal products was examined.
Maltese: Fi studji ta' farmakoloġija klinika, il-potenzjal biex tadalafil (10 u 20 mg) iżid l-effetti ipotensivi tal mediċini li jintużaw kontra l-pressjoni għolja kien eżaminat.
English: Only tadalafil 40 mg achieved the protocol defined level of significance with a placeboadjusted median increase in 6MWD of 26 metres (p=0.0004; 95 % CI: 9.5, 44.0; Pre-specified Hodges-Lehman method) (mean 33 metres, 95 % CI: 15.2, 50.3).
Maltese: Iż-żieda medjana, aġġustata għall-plaċebo, fis-6MWD kienet ta' 17-il metru (p=0.09; 95% CI: : -7.1, 43.0;
English: (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Maltese: fsada mestrwali eċċessiva/mhux normali bħal menorraġja, metrorraġja, menometrorraġja jew emorraġija vaġinali.
English: In the pivotal placebo-controlled study of ADCIRCA for the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
Maltese: Fl-istudju priċipali kkontrollat bil-plaċebo ta' ADCIRCA fil-kura ta' PAH, total ta' 323 pazjent kienu kkurati b'ADCIRCA b'dożi li varjaw minn 2.5 mg sa 40 mg kuljum u 82 pazjent kienu kkurati bil plaċebo.
English: EXP
Maltese: talc
English: In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Maltese: F'studji ta' interazzjoni bejn il-mediċini magħmula fuq numru limitat ta' volontiera b'saħħithom, dawn l-effetti ma ġewx irrapportati b'alfuzosin u tamsulosin.
English: Gastrointestinal disorders Nausea,
Maltese: Disturbi gastro-intestinali
English: Tadalafil 20 mg 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 20 mg 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: Acute myocardial infarction within the last 90 days.
Maltese: Infart mijokardijaku akut f'dawn l-aħħar 90 ġurnata.
English: Not known1
Maltese: Mhux magħruf1
English: The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
Maltese: L-aktar reazzjonijiet avversi komuni, li seħħew f' ≥ 10 % tal-pazjenti fil-fergħa ta' kura b'tadalafil 40 mg, kienu l-uġigħ ta' ras, id-dardir, l-uġigħ tad-dahar, id-dispepsja, il-ħmura fil-wiċċ, il-majalġja, in-nasofarinġite u l-uġigħ fl-estremitajiet.
English: Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0 %) and related to collagen vascular disease (23.5 %).
Maltese: 5%) u nisa (78.3 %).Il-parti l-kbira tal-etjoloġiji tal-ipertensjoni arterjali pulmonarja kienu PAH idjopatika (61.0%) u relatata ma' mard vaskulari tal-kollaġini (23.5%).
English: Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered.
Maltese: Minħabba esperjenza klinika limitata f'pazjenti b'ċirrożi epatika ħafifa għal moderata (Child-Pugh ta' Klassi A u B), wara dożi individwali ta' 10 mg, tista' tiġi kkunsidrata doża li tibda minn 20 mg darba kuljum.
English: ADCIRCA is a treatment for pulmonary arterial hypertension in adults.
Maltese: ADCIRCA huwa trattament għall-pressjoni għolja fl-arterji pulmonari fl-adulti.
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Nasofarinġite (li tinkludi imnieħer miżdud, sinusis miżdudin u rinite).
English: The placebo-adjusted median increase in 6MWD was 17 metres (p=0.09; 95 % CI: : -7.1, 43.0; Prespecified Hodges-Lehman method) (mean 23 metres, 95 % CI; -2.4, 47.8) in those patients who received tadalafil 40 mg in addition to their concomitant bosentan (n=39), and was 39 metres (p<0.01, 95 % CI:13.0, 66.0; Pre-specified Hodges-Lehman method) (mean 44 metres, 95 % CI: 19.7, 69.0) in those patients who received tadalafil 40 mg alone (n=37).
Maltese: 8) f'dawk il-pazjenti li rċevew tadalafil 40 mg flimkien ma' bosentan li kienu diġà qed jieħdu (n=39) u kien ta' 39 metru (p<0.01, 95% CI:13.0, 66.0; Metodu
English: A risk to the breastfed child cannot be excluded.
Maltese: Ir-riskju għat-tarbija li qed titredda' mhux eskluż.
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 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' tadalafil 10 mg (studju wieħed ta' 6 xhur) u 20 mg (studju wieħed ta' 6 xhur u studju wieħed ta' 9 xhur) mogħtija kuljum.
English: LIST OF EXCIPIENTS lactose
Maltese: ADCIRCA fih il-lactose
English: In patients who are taking alpha1 blockers concomitant administration of tadalafil may lead to symptomatic hypotension in some patients (see section 4.5).
Maltese: F'pazjenti li qed jieħdu alpha1 blockers, l-amministrazzjoni konkomitanti ta' tadalafil tista' twassal għal ipotensjoni sintomatika f'xi pazjenti (ara sezzjoni 4.5).
English: Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Maltese: 700 darba aktar potenti għal PDE5 milli għal PDE6, li hija enżima li tinsab fir-retina u li hija responsabbli għall-fototransduzzjoni.
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: Patients were randomised to one of five treatment groups (tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg, or placebo).
Maltese: 10 mg,20 mg, 40 mg jew plaċebo).
English: Effects of tadalafil on other medicinal products
Maltese: Effetti ta' tadalafil fuq prodotti mediċinali oħrajn
English: Of these, 311 patients had been treated with tadalafil for at least 6 months and 293 for 1 year (median exposure 365 days; range 2 days to 415 days).
Maltese: Minn dawn, 311-il pazjent kienu ġew ikkurati b'tadalafil għal mill-inqas 6 xhur u 293 għal sena (espożizzjoni medjana ta' 365 ġurnata; marġni ta' jumejn sa 415-il ġurnata).
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: Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara ‘JIS'.
English: Musculoskeletal, connective tissue and bone disorders Myalgia,
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue
English: Common (may affect up to 1 in 10 people) - blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) - vista mċajpra, pressjoni baxxa tad-demm, faġra, rimettar, żieda fid-demm mill-utru jew li mhuwiex normali, reazzjonijiet allerġiċi (li jinkludu raxxijiet fil-ġilda), nefħa fil-wiċċ, rifluss tal-aċidu mill-istonku, emigranja, qalb li tħabbat b'mod irregolari u ħass ħażin.
English: Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.
Maltese: F'suġġetti b'saħħithom, fi skala ta' doża minn 2.5 sa 20 mg, l-esponiment (AUC) ta' tadalafil jiżdied b'mod proporzjonali għad-doża.
English: Blurred vision
Maltese: Vista mċajpra
English: The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23 % vs. 21 %).
Maltese: Il-proporzjon ta' pazjenti li kellhom titjib fil-klassi ta' funzjonament WHO sas-16-il ġimgħa kien simili fil-gruppi ta' tadalafil 40 mg u tal-plaċebo (23% kontra 21%).L-inċidenza ta' pazjenti li wara
English: What ADCIRCA contains
Maltese: Insuffiċjenza epatika
English: Tadalafil 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: Tadalafil għandu jintuza b'kawtela f'pazjenti b'diformazzjoni anatomika tal-pene (bħal angolazzjoni, fibrozi kavernożali jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jistgħu jippredisponuhom għal prijapiżmu (bħal sickle cell enemija, majeloma multipla jew lewkimja).
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: More than half (53.3 %) of the patients in the study were receiving concomitant bosentan therapy.
Maltese: Aktar minn nofs (53.3%) tas-suġġetti fl-istudju kienu qed jirċievi t-terapija bosentan fl-istess ħin.
English: Doses studied were 20 mg and 40 mg once daily.
Maltese: Id-dożi li ġew studjati kienu ta' 20 mg u ta' 40 mg darba kuljum.
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mmHg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p<0.05).
Maltese: .3mmHg) u r resiżtenza vaskulari pulmonarja (-209dyn.
English: Additionally, improvements compared to placebo were observed with tadalafil 40 mg in the physical functioning, role-physical, bodily pain, general health, vitality and social functioning domains of the SF-36.
Maltese: Barra minn hekk, meta mqabbel ma' plaċebo ġie osservat titjib b'tadalafil 40 mg fil-funzjonament fiżiku, rwol-fiżiku, uġigħ fil-ġisem, saħħa in ġenerali, vitalità u fl-isferi ta' funzjonament soċjali talSF-36.
English: This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Maltese: Din is-selettivita' għal PDE5 fuq il-PDE3 hija importanti għaliex PDE3 hija enżima li hija involuta fil-kontrattilita' kardijaka.
English: Cytochrome P450 Inhibitors
Maltese: Sustanzi li jistimulaw iċ-Ċitokromu P450
English: P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Maltese: Tadalafil (40 mg darba kuljum) ma kellu ebda effett klinikament sinifikanti fuq il-farmakokinetika ta' digoxin.
English: Changes in the Borg dyspnoea score were small and non-significant with both placebo and tadalafil 40 mg.
Maltese: Borg kienu żgħar u mhux sinifikanti kemm bil-plaċebo u kemm b'tadalafil 40 mg.
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25 % higher exposure (AUC) relative to healthy subjects aged 19 to 45 years after a 10 mg dose.
Maltese: Anzjani b'saħħithom (65 sena jew akbar) kellhom tneħħija aktar baxxa ta' tadalafil meħud oralment, li rriżulta f 25 % aktar esponiment (AUC) meta mqabbel ma' individwi b'saħħithom ta' eta' minn 19 sa 45 sena wara doża ta' 10 mg.
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Maltese: Mhijiex magħrufa biċ-ċert ir rilevanza klinika ta' din is-sejba.
English: Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Maltese: Il-konċentrazzjonijiet tal-alkoħol ma kinux affettwati meta tadalafil jingħata fl-istess ħin (10 mg jew 20 mg).
English: Eli Lilly Polska Sp. z o.o.
Maltese: Italia Eli Lilly Italia S.p.A.
English: How to take ADCIRCA
Maltese: X'fih ADCIRCA
English: ADCIRCA is supplied as a 20 mg tablet.
Maltese: ADCIRCA jiġi bħala pillola ta' 20 mg.
English: For those patients for which there are data, the survival rate at 1 year is 96.4 %.
Maltese: Għal dawk il pazjenti li dwarhom hemm infomazzjoni, ir-rata ta' sopravivenza wara sena hi ta' 96.4%.
English: A similar increase in AUC and Cmax seen with ethinylestradiol may be expected with oral administration of terbutaline, probably due to inhibition of gut sulphation by tadalafil.
Maltese: Żieda simili fl-AUC u s- Cmax kif deher f' ethinylestradiol tista' tkun mistennija bit-teħid orali ta' terbutaline, wisq probabbli minħabba l-inibizzjoni tas-sulfazzjoni fl-imsaren permezz ta' tadalafil.
English: At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26 % and Cmax by 70 % relative to oral contraceptive administered with placebo.
Maltese: Il-Pillola kontraċettiva orali Fl-istat fiss, tadalafil (40 mg darba kuljum) żied l-espożizzjoni (AUC) ta' ethinylestradiol b'26 % u s
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: L-għoti 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: There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 1000 mg/kg/day tadalafil.
Maltese: Ma kien hemm ebda evidenza ta' teratoġeniċità jew ta' effett tossiku fuq l-embriju jew il-fetu f'firien jew ġrieden li rċevew sa 1000 mg/kg/jum tadalafil.
English: In patients with pulmonary hypertension not receiving concomitant bosentan, the average tadalafil exposure at steady-state following 40 mg was 26 % higher when compared to those of healthy volunteers.
Maltese: F'pazjenti b'ipertensjoni pulmonarja li mhux qed jirċievu bosentan fl-istess ħin, il-medja tal esponiment ta' tadalafil fl-istat fiss wara 40 mg kien 26 % ogħla meta mqabbel ma' dawk ta'
English: The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
Maltese: Il-gruppi ta' pazjenti li ġejjin b'mard kardjovaskulari ma ġewx inklużi fl-istudji kliniċi ta' PAH:
English: Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Maltese: Okklużjoni vaskulari tarretina, Difett fil kamp viżiv
English: The adverse reactions reported were transient, and generally mild or moderate.
Maltese: Ir-reazzjonijiet avversi li ġew irrapportati kienu temporanji u ħafna drabi ħfief jew moderati.
English: The mean oral clearance for tadalafil is 3.4 l/h at steady state and the mean terminal half-life is 16 hours in healthy subjects.
Maltese: Eliminazzjoni It-tneħħija medja orali ta' tadalafil hija 3.4 l/siegħa fl-istat fiss u l-medja tal-half-life terminali hija ta'
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' doxazosin (4 u 8 mg kuljum) u tadalafil (doża ta' 5 mg kuljum u doża waħda ta'
English: Hepatic impairment
Maltese: Disturbi vaskulari
English: However, post hoc analyses demonstrated that changes from baseline in cardiopulmonary hemodynamic parameters for the tadalafil 40 mg treatment group were not significantly different compared to placebo.
Maltese: Madankollu, analiżi post hoc wera li t-tibdil mil-linja bażi tal-parametri emodinamiċi kardjopulmonarji għall-grupp ta' kura ta' tadalafil 40 mg ma kienux differenti b'mod sinifikanti meta mqabbla ma' dawk ta'
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32 % and decreased Cmax by 30 %.
Maltese: Ritonavir (500 mg jew 600 mg darbtejn kuljum) żied l-esponiment (AUC) ta' doża waħda ta' tadalafil
English: PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta' PDE5, bħal ADCIRCA, iżidu l-effetti ipotensivi ta' din il mediċina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
Maltese: Kull pillola miksija b'rita fiha 20 mg tadalafil.
English: Therefore, this combination is not recommended (see section 4.4).
Maltese: Għalhekk it-teħid ta' dawn it-tnejn flimkien mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Maltese: nitrat organiku huwa kontraindikat (ara sezzjoni 4.3 ).
English: During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5 fold of that after a single dose.
Maltese: Waqt id-dożaġġ ta' tadalafil 20 mg u 40 mg darba kuljum, konċentrazzjonijiet fissi fil plażma ġew milħuqa fi żmien 5 ijiem u l-esponiment hija ta' madwar 1.5 darbiet ta' dik wara doża waħda.
English: Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Maltese: Tiħux ADCIRCA meta tkun tqila, sakemm mhux assolutament neċessarju u ddiskutejtha mat-tabib tiegħek.