FrancophonIA/ELRC3.0 huggingface dataset:
English: Mylan Denmark ApS Tlf: +45 28 11 69 32
Maltese: Mylan Denmark ApS Tlf: +45 28 11 69 32 (Sverige)
English: Salomone Pharma Ltd Tel: +356 21 22 01 74
Maltese: V.J. Salomone Pharma Ltd Tel: +356 21 22 01 74
English: Varnavas Hadjipanayis Ltd Τηλ: +357 222 077 23
Maltese: Varnavas Hadjipanayis LtdΤηλ: +357 222
English: Sodium laurilsulfate
Maltese: Sodium laurilsulfate Poloxamer 188
English: The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin.
Maltese: Il-kisja tar-rita fiha lactose monohydrate (ara sezzjoni 2 ‘Talmanco fih lactose'), hypromellose (E464), titanium dioxide (E171) u triacetin.
English: Talmanco with alcohol
Maltese: Talmanco mal-alkoħol
English: The other ingredients in the tablet core are povidone, sodium laurilsulfate, poloxamer 188, anhydrous lactose (see section 2 ‘Talmanco contains lactose'), microcrystalline cellulose (PH 101), croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.
Maltese: Is-sustanzi l-oħra fil-qalba tal-pillola huma povidone, sodium laurilsulfate, poloxamer 188, anhydrous lactose (ara sezzjoni 2 ‘Talmanco fih il-lactose'), microcrystalline cellulose (PH 101), croscarmellose sodium, colloidal anhydrous silica u magnesium stearate.
English: Mylan Healthcare SIA Tel: +371 676 055 80
Maltese: Latvija Mylan Healthcare SIATel: +371 676 055 80
English: Patients were randomised to one of five treatment groups (tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg, or placebo).
Maltese: B'mod arbitrarju l-pazjenti ġew mqassma f'ħames gruppi differenti ta' kura (tadalafil 2.5 mg, 10 mg,20 mg, 40 mg jew plaċebo).
English: Frequency estimate: 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: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1000), Rari
English: 28 film-coated tablets 28 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets
Maltese: 28 pillola miksijin b'rita 28 x 1 pillola miksija b'rita 56 pillola miksijin b'rita 56 x 1 pillola miksija b'rita
English: Seizures Transient amnesia5
Maltese: Konvulżjonijiet5, Amnesija temporanja5
English: Microcrsytalline cellulose (PH 101) Croscarmellose sodium
Maltese: Anhydrous lactose Microcrystalline cellulose (PH 101) Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
English: nosebleed.
Maltese: puplesija.
English: Immune system disorders Hypersensitivity reactions5
Maltese: Disturbi fis-sistema immuni Reazzjonijiet ta' sensittività eċċessiva
English: Palpitations2, 5
Maltese: Effetti sekondarji possibbli 5.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intoleranza għall-galactose, ta' nuqqas ta' Lapp lactase jew ta' malassorbiment ta'glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Maltese: Antagonisti tar-riċettur endothelin-1 (eż. bosentan) Bosentan (125 mg darbtejn kuljum), sustrat ta' CYP2C9 u CYP3A4 u stimulatur moderat ta' CYP3A4, CYP2C9 u wisq probabbli ta' CYP2C19, naqqas l-espożizzjoni sistemika ta' tadalafil (40 mg darba kuljum) b'42% u s-Cmax b'27% wara t-teħid flimkien ta' dożi multipli.
English: PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 x 1 and 56 x 1 film-coated tablets.
Maltese: Folji perforati ta' l-unita` tal-PVC/PVdC-Alu f'kartuna li jkun fihom 28 x 1 u 56 x 1 pillola miksija b'rita.
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mm Hg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p < 0.05).
Maltese: 6L/min) u naqqas il-pressjoni fl-arterja pulmonarja (-4.3mm Hg) u rresiżtenza vaskulari pulmonarja (-209dyn.
English: Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0%) and related to collagen vascular disease (23.5%).
Maltese: 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: Film-coating:
Maltese: Stima tal-frekwenza:
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, uġigħ/skumdità, fatturi ta' ansjetà/dipressjoni u fl-iskala viżiva analog (VAS).
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 tal- pressjoni tad-demm ikkawżata millalkoħol (0.7 g/kg jew madwar 180 ml ta' 40% alkoħol [vodka] f'raġel ta' 80 kg) iżda f'xi individwi, kienu osservati sturdament dovut għat-tibdil fil-pożizzjoni tal-persuna u ipotensjoni ortostatika..
English: Talmanco 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: Talmanco 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: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22%.
Maltese: Ketoconazole (400 mg kuljum) żied l-espożizzjoni (AUC) ta' doża waħda ta'tadalafil (20 mg) b'erba darbiet u Cmax bi 22%.
English: How to store Talmanco 6.
Maltese: Kif taħżen Talmanco 6.
English: Rare (may affect up to 1 in 1,000 people) sudden loss of vision.
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna) telf f'daqqa tal-vista.
English: The majority of patients had a World Health Organization (WHO) Functional Class III (65.2%) or II (32.1%).
Maltese: III (65.2%) jew II (32.1%) ta' Funzjonament skont l-Organizzazzjoni Dinija tas-Saħħa (WHO).
English: Other medicines and Talmanco
Maltese: Mediċini oħra u Talmanco
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: Tadalafil 40 mg biss laħaq il-livell ta' sinifikanza kif definit fil-protokoll b'żieda medjana fis-6MWD ta' 26 metru aġġustat għall-plaċebo (p = 0.0004; 95% CI: 9.5, 44.0; Metodu Hodges-Lehman kif speċifikat minn qabel) (medja ta' 33 metres, 95% CI: 15.2, 50.3). It-titjib fid-distanza ta' mixi deher wara 8 ġimgħat ta' kura.
English: Poloxamer 188
Maltese: G04BE08.
English: Talmanco is a treatment for pulmonary arterial hypertension in adults.
Maltese: Talmanco huwa trattament għall-pressjoni għolja fl-arterji pulmonari fl-adulti.
English: In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Maltese: - Fi studji kliniċi, tadalafil intwera li jkabbar l-effetti ipotensivi tan-nitrati.
English: Priapism5, Penile haemorrhage, Haematospermia
Maltese: Prijapiżmu5, Emorraġija filpene,
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: 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: 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 (20 mg) b'32% u naqqas is-Cmax b'30%.
English: Adverse reaction data are limited in patients over 75 years of age.
Maltese: Huwa limitat it-tagħrif dwar reazzjonijiet avversi f'pazjenti 'l fuq minn 75 sena.
English: Talmanco is supplied as a 20 mg tablet.
Maltese: Talmanco jiġi bħala pillola ta' 20 mg.
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 mg-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: Reproductive system and breast disorders Increased uterine bleeding4
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Żieda fil-fsada uterina4
English: Talmanco 20 mg film-coated tablets tadalafil
Maltese: Talmanco 20 mg pilloli miksijin b'rita tadalafil
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 talprotrombin kkawżat mill-warfarin.
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: Fl-istat fiss, tadalafil (40 mg darba kuljum) żied l-espożizzjoni (AUC) ta' ethinylestradiol b'26% u sCmax b'70% meta mqabbel ma meta l-kontraċettiv orali ttieħed mal-plaċebo.
English: PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-PVC/PE/PVdC-Alu f'kartuna li fihom 28 u 56 pillola miksija b'rita.
English: This medicine is available in blister packs containing 28 or 56 tablets and in perforated unit dose blister packs containing 28 x 1 or 56 x 1 tablets.
Maltese: Din il-mediċina hi disponibbli f'pakketti bil-folji li jkun fihom 28 jew 56 pillola u f'pakketti ta' folji ta 'doża waħda perforati li jkun fihom 28 x 1 jew 56 x 1 pillola.
English: PDE5 inhibitors, such as Talmanco, have been shown to increase the hypotensive effects of this medicine.
Maltese: Ġie muri li inibituri ta' PDE5, bħal Talmanco, iżidu l-effetti ipotensivi ta' din ilmediċina.
English: Anhydrous lactose
Maltese: Talmanco fih il-lactose
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 (ara sezzjoni 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 Talmanco is and what it is used for Talmanco contains the active substance tadalafil.
Maltese: Talmanco fih is-sustanza attiva tadalafil.
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: Anti-ipertensivi (li jinkludu sustanzi li jimblukkjaw il-passaġġi tal-Kalċju) It-teħid flimkien ta' doxazosin (4 u 8 mg kuljum) u tadalafil (doża ta' 5 mg kuljum u doża waħda ta' 20 mg) iżid b'mod sinifikanti l-effett tat-tnaqqis fil-pressjoni tad-demm ta' dan l-imblokkatur tarreċetturi alpha.
English: hives.
Maltese: Sess
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 talmediċini li jintużaw kontra l-pressjoni għolja kien eżaminat.
English: Talmanco tablets contain lactose.
Maltese: Il-pilloli Talmanco fihom il-lactose.
English: Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Maltese: Acetylsalicylic acid Tadalafil (10 mg 20 mg) ma kabbarx iż-żieda fil-ħin ta' fsada kkawżat minn acetyl salicylic acid.
English: In the pivotal placebo-controlled study of tadalafil for the treatment of PAH, a total of 323 patients were treated with tadalafil 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' tadalafil fil-kura ta' PAH, total ta' 323 pazjent kienu kkurati b'tadalafil b'dożi li varjaw minn 2.5 mg sa 40 mg kuljum u 82 pazjent kienu kkurati bilplaċebo.
English: Patients were at least 12 years of age and had a diagnosis of PAH that was idiopathic, related to collagen disease, related to anorexigen use, related to human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of at least 1 year in duration of a congenital systemic-to-pulmonary shunt (for example, ventricular septal defect, patent ductus arteriosus).
Maltese: Is-suġġetti kellhom mill-inqas 12-il sena u kellhom dijanjosi ta' PAH li kienet idjopatika u relatata ma' mard tal-kollaġini, relatata mal-użu anoreksiġenu, relatata malinfezzjoni tal-virus ta' immunodefiċjenza umana (HIV), assoċjata ma' difett atriju-settali jew assoċjata ma' intervent kirurġiku ta' tiswija li ilu li sar għall-inqas sena ta' ‘shunt' sistemiku għal pulmonarju konġenitali, (per eżempju difett settali ventrikulari, patent ductus arteriosus).
English: Haematuria
Maltese: Ematospermja
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets tadalafil
Maltese: Talmanco 20 mg pilloli miksija b'rita tadalafil
English: Vomiting, Gastroesophageal reflux
Maltese: Disturbi gastro-intestinali
English: Tell your doctor or pharmacist if you are already taking: bosentan (another treatment for pulmonary arterial hypertension) nitrates (for chest pain) alpha blockers used to treat high blood pressure or prostate problems riociguat rifampicin (to treat bacterial infections) ketoconazole tablets (to treat fungal infections) ritonavir (for HIV treatment) tablets for erectile dysfunction (PDE5 inhibitors)
Maltese: Għid lit-tabib jew lill-ispiżjar tiegħek jekk diġà qed tieħu: bosentan (kura oħra għall-pressjoni għolja fl-arterji pulmonari) nitrati (għall-uġigħ fis-sider) imblokkatur tar-riċetturi alfa li jintużaw għall-pressjoni għolja jew għall-problemi fil-prostata riociguat rifampicin (għall-kura ta' infezzjonijiet tal-batteri) pilloli ta' ketoconazole (għall-kura ta' infezzjonjiet tal-fungi) ritonavir (għall-kura tal-HIV) pilloli għad-disfunzjoni erettili (inibituri ta' PDE5)
English: The mean age of all patients was 54 years (range 14 to 90 years) with the majority of patients being Caucasian (80.5%) and female (78.3%).
Maltese: 5%) u nisa (78.3%).
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: 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: What Talmanco looks like and contents of the pack This medicine is a white, film-coated, round, biconvex, bevelled edge tablet marked with ‘M' on one side of the tablet and ‘TA20' on the other side.
Maltese: Din il-mediċina hi pillola miksija b'rita, bajda, tonda, bikonvessa, bit-tarf iċċanfrat, immarkata b'‘M' fuq naħa waħda tal-pillola u ‘TA20' fuq in-naħa l-oħra.
English: Magnesium stearate
Maltese: Kif gћandek tieћu Talmanco
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: .0; Metodu Hodges-Lehman kif speċifikat minn qabel) (medja ta' 44 metres, 95% CI: 19.7, 69.0) f'dawk il-pazjenti li rċevew tadalafil 40 mg biss (n = 37).
English: Patients with clinically significant aortic and mitral valve disease Patients with pericardial constriction Patients with restrictive or congestive cardiomyopathy Patients with significant left ventricular dysfunction Patients with life-threatening arrhythmias Patients with symptomatic coronary artery disease Patients with uncontrolled hypertension.
Maltese: Pazjenti b'mard tal-valvola aortika u mitrali klinikament sinifikanti Pazjenti b'restrizzjoni perikardjali Pazjenti b'kardjomijopatija restrittiva jew konġestiva Pazjenti b'disfunzjoni sinifikanti fil-ventriklu tax-xellug Pazjenti b'arritmi li jistgħu jikkawża l-mewt Pazjenti b'mard tal-arterji koronarji bis-sintomi Pazjenti b'ipertensjoni li mhijiex ikkontrollata.
English: 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: Urticaria5, Hyperhydrosis (sweating)
Maltese: Urtikarja5, Iperidrosi (ħafna għaraq)
English: Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3)
Maltese: Dardir, Dispepsja (li tinkludi uġigħ/dwejjaq addominali3)
English: Cardiovascular
Maltese: Palpitazzjonijiet
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' plaċebo.
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: A risk to the breast-fed child cannot be excluded.
Maltese: Ir-riskju għat-tarbija li qed titredda' mhux eskluż.
English: How to take Talmanco 4.
Maltese: Kif għandek tieħu Talmanco 4.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg tadalafil.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 20 mg tadalafil
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: 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 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: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets
Maltese: Talmanco 20 mg pilloli miksijin b'rita
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with tadalafil.
Maltese: It-tabella hawn taħt turi r-reazzjonijiet avversi rrapportati waqt l-istudju kliniku kkontrollat bil-plaċebo f'pazjenti b'PAH ikkurati b'tadalafil.
English: Talk to your doctor or pharmacist before taking this medicine if you have: any heart problems other than your pulmonary hypertension problems with your blood pressure any hereditary eye disease an abnormality of red blood cells (sickle cell anaemia) cancer of the bone marrow (multiple myeloma) cancer of the blood cells (leukaemia) any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours a serious liver problem a serious kidney problem
Maltese: xi problemi tal-qalb oħra minbarra l-pressjoni għolja fl-arterji pulmonari problemi bil-pressjoni xi mard tal-għajnejn ereditarju anormalità taċ-ċelloli ħomor tad-demm (anemija b'ċelloli forma ta' minġel) kanser tal-mudullun tal-għadam (mijeloma multipla) kanser taċ-ċelloli tad-demm (lewkimja) xi deformazzjoni fil-pene, jew erezzjonijiet mhux mixtieqa jew persistenti li jdumu aktar minn 4 sigħat problema serja fil-fwied problema serja fil-kliewi
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 filplażma ġew milħuqa fi żmien 5 ijiem u l-esponiment hija ta' madwar 1.5 darbiet ta' dik wara doża waħda.
English: Uncommon (may affect up to 1 in 100 people) priapism, a prolonged and possibly painful erection after taking this medicine.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) prijapiżmu, erezzjoni fit-tul u possibilment bl-uġigħ wara li tieħu din il-mediċina.
English: Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Maltese: Newropatija ottika iskemika anterjuri li m'hijiex arteritika (NAION)
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 talesponiment ta' tadalafil fl-istat fiss wara 40 mg kien 26% ogħla meta mqabbel ma' dawk ta' volontiera b'saħħithom.
English: Pharmaceutical Form Route of Administration
Maltese: Għamla Farmaċewtika