FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Ocene pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.
Slovenian: Manj kot 0,0005% danega odmerka se je pojavilo v spermi zdravih oseb.
English: Stevens-Johnson Syndrome, Exfoliative dermatitis
Slovenian: Stevens-Johnsonov sindrom, eksofoliativni dermatitis
English: More than half (53.3%) of the patients in the study were receiving concomitant bosentan therapy.
Slovenian: Več kot polovica (53,3%) bolnikov v študiji je sočasno prejemala zdravljenje s bosentanom.
English: If you have taken or are planning to take Talmanco, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Slovenian: Če ste vzeli ali nameravate vzeti zdravilo Talmanco, se izogibajte prekomernemu pitju (več kot 5 enot alkohola), saj lahko to vpliva na tveganje za omotico pri vstajanju.
English: At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Slovenian: Pri terapevtskih koncentracijah je 94% tadalafila v plazmi vezanega na beljakovine.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately:
Slovenian: Če se pojavi kateri koli od naslednjih neželenih učinkov, prenehajte jemati zdravilo in nemudoma poiščite zdravniško pomoč:
English: The overall frequency of discontinuation due to adverse events was low (tadalafil 11%, placebo 16%).
Slovenian: Skupna pogostnost prenehanja zaradi neželenih učinkov je bila nizka (tadalafil 11%, placebo 16%).
English: Patients should be informed not to take tadalafil with these medicinal products.
Slovenian: Bolnike je potrebno obvestiti, naj tadalafila ne jemljejo skupaj s temi zdravili.
English: Significant improvement (p < 0.01) in the 6MWD was demonstrated at week 12 when the patients were asked to delay taking study medicinal product in order to reflect trough active substance concentration.
Slovenian: Signifikantno izboljšanje (p < 0.01) pri 6MWD je bilo vidno v 12. tednu, ko je bilo bolnikom naročeno, naj počakajo z jemanjem naslednjega odmerka preučevanega zdravila, da bi se ugotovile najnižje koncentracije učinkovine.
English: If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Slovenian: Če dobite takšno erekcijo, ki traja neprestano več kot 4 ure, nemudoma obvestite zdravnika.
English: Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk.
Slovenian: Med jemanjem tablet ne dojite, saj ni znano, ali zdravilo prehaja v mleko.
English: Priapism and anatomical deformation of the penis
Slovenian: Priapizem in anatomska deformacija penisa
English: Tadalafil has negligible influence on the ability to drive or use machines.
Slovenian: Tadalafil ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja s stroji.
English: The majority of patients had a World Health Organization (WHO) Functional Class III (65.2%) or II (32.1%).
Slovenian: Večina bolnikov je bila v funkcijskem razredu III (65,2%) ali II (32,1%) po razvrstitvi Svetovne zdravstvene organizacije (SZO).
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%).
Slovenian: Srednja starost bolnikov je bila 54 let (od 14 do 90 let), večina je bila kavkaške rase (80,5%) in ženskega spola (78,3%).
English: Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Slovenian: Če ste noseči, tega zdravila ne uporabljajte, razen če je to nujno potrebno in ste se o tem pogovorili z zdravnikom.
English: If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
Slovenian: Če imate blage ali zmerne težave z delovanjem jeter ali ledvic vam bo zdravnik morda svetoval, da vzamete le eno 20 mg tableto na dan.
English: Therefore, the combination of tadalafil and doxazosin is not recommended.
Slovenian: Kombinacija tadalafila in doksazosina zato ni priporočljiva.
English: The safety and efficacy of tadalafil in the paediatric population has not yet been established.
Slovenian: Varnost in učinkovitost tadalafila pri pediatrični populaciji še nista bila dokazani.
English: If you forget to take Talmanco
Slovenian: Če ste pozabili vzeti zdravilo Talmanco
English: Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil.
Slovenian: Večina, a ne vsi moški, pri katerih so poročali o hitrem bitju srca, neenakomernem bitju srca, srčnem infarktu, možganski kapi in nenadni srčni smrti, so imeli težave s srcem že pred jemanjem tadalafila.
English: The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
Slovenian: Srčno-žilni sistem Naslednje skupine bolnikov s srčno-žilnimi boleznimi niso bile vključene v klinične študije PAH:
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).
Slovenian: Tadalafil se izloča predvsem v obliki neaktivnih presnovkov, večinoma z blatom (približno 61% odmerka), v manjšem obsegu pa z urinom (približno 36% odmerka).
English: Some medicines may be affected by Talmanco or they may affect how well Talmanco will work.
Slovenian: Zdravilo Talmanco lahko vpliva na nekatera zdravila ali pa lahko zdravila vplivajo na delovanje zdravila Talmanco.
English: See leaflet for further information.
Slovenian: Za nadaljnje informacije glejte navodilo za uporabo!
English: Uncommon (may affect up to 1 in 100 people) priapism, a prolonged and possibly painful erection after taking this medicine.
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - priapizem, podaljšana in morda boleča erekcija po jemanju tega zdravila.
English: As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking tadalafil and consult a physician immediately (see section 4.3).
Slovenian: Ker je to morda pomembno za vse bolnike, ki so izpostavljeni tadalafilu, je treba bolnika opozoriti, da naj v primeru nenadne okvare vida preneha jemati tadalafil in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4.3).
English: The rate and extent of absorption of tadalafil are not influenced by food, thus tadalafil may be taken with or without food.
Slovenian: Ker hrana ne vpliva na stopnjo in obseg absorpcije tadalafila, se lahko tadalafil vzame s hrano ali brez nje.
English: Other medicines and Talmanco
Slovenian: Druga zdravila in zdravilo Talmanco
English: The European Medicines Agency has deferred the obligation to submit the results of studies with tadalafil in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s tadalafilom za eno ali več podskupin pediatrične populacije za zdravljenje pljučne arterijske hipertenzije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects.
Slovenian: Pri bolnikih v programu hemodialize je bila Cmax 41% višja kot opažana pri zdravih osebah.
English: Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Slovenian: Učinkovitost pri bolnikih s pljučno arterijsko hipertenzijo (PAH) Randomizirana, dvojno slepa, s placebom kontrolirana študija je bila opravljena pri 405 bolnikih s pljučno arterijsko hipertenzijo.
English: 28 film-coated tablets 28 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 56 filmsko obloženih tablet 56 x 1 filmsko obložena tableta
English: Allowed background therapy included bosentan (stable maintenance dose up to 125 mg twice daily) and chronic anticoagulation, digoxin, diuretics and oxygen.
Slovenian: Dovoljena osnovna terapija je vključevala bosentan (stabilen vzdrževalni odmerek do 125 mg dvakrat na dan), kronično antikoagulantno zdravljenje, digoksin, diuretike in kisik.
English: What you need to know before you take Talmanco
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Talmanco
English: Elderly Dose adjustments are not required in elderly patients.
Slovenian: Starostniki Odmerka pri starejših bolnikih ni potrebno prilagajati.
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of doxazosin -see above) is, in general, minor and not likely to be clinically relevant.
Slovenian: Pri bolnikih, ki sočasno prejemajo antihipertenzivna zdravila, lahko tadalafila 20 mg povzroči znižanje krvnega tlaka, ki je (z izjemo doksazocina - glejte zgoraj) v splošnem majhno in ni verjetno, da bi bilo klinično pomembno.
English: The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.
Slovenian: Skupni rezultati o varnosti so bili v tej študiji na splošno skladni z znanim varnostnim profilom tadalafila in z neželenimi učinki, pričakovanimi v pediatrični populaciji z DMD, ki prejema kortikosteroide.
English: If you stop taking Talmanco Do not stop taking your tablets, unless advised otherwise by your doctor.
Slovenian: Če ste prenehali jemati zdravilo Talmanco Zdravila ne prenehajte jemati, razen , če vam tega ne naroči zdravnik.
English: Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical studies was similar, patients should be aware of how they react to tadalafil, before driving or operating machinery.
Slovenian: Kljub temu, da so bile pogostnosti poročanja o omotici v skupinah prejemanja placeba in tadalafila v kliničnih študijah podobne, naj se bolniki pred vožnjo ali upravljanjem strojev zavedajo, kako se odzovejo na tadalafil.
English: INFORMATION IN BRAILLE Talmanco 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Talmanco 20 mg
English: If you experience sudden decrease or loss of vision, contact your doctor immediately.
Slovenian: Če doživite nenadno poslabšanje ali izgubo vida, o tem nemudoma obvestite zdravnika.
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs.
Slovenian: Spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5), ki delujejo tako, da pomagajo pri sproščanju (širjenju) krvnih žil okoli pljuč, kar izboljša pretok krvi v pljuča.
English: Talmanco is a treatment for pulmonary arterial hypertension in adults.
Slovenian: Zdravilo Talmanco je indicirano za zdravljenje pljučne arterijske hipertenzije pri odraslih.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects after a 10 mg dose.
Slovenian: Izpostavljenost tadalafilu (AUC) je bila pri bolnikih s sladkorno boleznijo približno 19% nižja kot vrednost AUC za zdrave osebe po dajanju odmerka 10 mg.
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.
Slovenian: Pri bolnikih s pljučno hipertenzijo, ki se sočasno niso zdravili z bosentanom, je bila povprečna izpostavljenost tadalafilu v stanju dinamičnega ravnovesja po prejetju odmerka 40 mg za 26% višja v primerjavi z zdravimi prostovoljci.
English: What Talmanco is and what it is used for Talmanco contains the active substance tadalafil.
Slovenian: Kaj je zdravilo Talmanco in za kaj ga uporabljamo Zdravilo Talmanco vsebuje učinkovino tadalafil.
English: PDE5 inhibitors, such as Talmanco, have been shown to increase the hypotensive effects of this medicine.
Slovenian: Zaviralci PDE5, kot je zdravilo Talmanco, dokazano povečujejo hipotenzivne učinke tega zdravila.
English: Use with CYP3A4 inducers or inhibitors
Slovenian: Uporaba z induktorji ali zaviralci CYP3A4
English: Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 237,9 mg laktoze (234,5 mg v obliki brezvodne laktoze in 3,4 mg v obliki monohidrata).
English: P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Slovenian: Substrat P-glikoproteina (npr. digoksin) Tadalafil (40 mg enkrat na dan) ni imel klinično pomembnega učinka na farmakokinetiko digoksina.
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.
Slovenian: Pri psih, ki so tadalafil prejemali na dan 6 do 12 mesecev v odmerkih 25 mg/kg/dan (kar pomeni vsaj 3-krat večjo izpostavljenost [razpon 3,7-18,6], kot je bila opažena pri ljudeh pri enkratnem odmerku 20 mg) in več, je prišlo do regresije epitela semenskih cevk, kar je pri nekaterih psih povzročilo zmanjšanje spermatogeneze.
English: Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical studies, and use in these patients is not recommended.
Slovenian: Bolniki z znano dedno degenerativno okvaro očesne mrežnice, vključno z retinitis pigmentosa, niso bili vključeni v klinične študije, zato uporaba pri teh bolnikih ni priporočljiva.
English: Tadalafil should not be used during breast-feeding.
Slovenian: Tadalafila se ne uporabljajte med dojenjem.
English: Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Slovenian: Tadalafil je močan in selektiven zaviralec fosfodiesteraze tipa 5 (PDE5); encima, ki je odgovoren za razgradnjo cikličnega gvanozinmonofosfata (cGMP).
English: Check carefully how you react to the medicines before driving or using any machinery.
Slovenian: Pred vožnjo ali upravljanjem s stroji skrbno preverite kako reagirate na zdravila.
English: These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of tadalafil.
Slovenian: Pogostnost teh učinkov je označena ali kot pogostnost »neznana«, saj se pogostnosti pri bolnikih s PAH ne more oceniti na osnovi podatkov, ki so na voljo, ali kot pogostnost na osnovi podatkov kliničnih študij iz ključne, s placebom kontrolirane študije tadalafila.
English: Talmanco with alcohol
Slovenian: Zdravilo Talmanco skupaj z alkoholom
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.
Slovenian: Randomizirano, dvojno slepo, s placebom nadzorovano paralelno študijo tadalafila s tremi skupinami preiskovancev so opravili s 331 fanti, starimi od 7 do 14 let, ki so imeli DMD in so prejemali sočasno zdravljenje s kortikosteroidi.
English: Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure.
Slovenian: Tadalafil ima sistemsko vazodilatorno delovanje, kar lahko povzroči prehodna znižanja krvnega tlak.
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).
Slovenian: Pogostnost kliničnega poslabšanje do 16. tedna je bila nižja pri bolnikih, ki so dobivali 40 mg tadalafila (5%; 4 od 79 bolnikov) kot pri bolnikih, ki so prejemali placebo (16%; 13 od 82 bolnikov).
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.
Slovenian: Zdrave starejše osebe (65 let ali več) so imele nižji peroralni očistek tadalafila, kar je po odmerku 10 mg povzročilo 25% višjo izpostavljenost (AUC) v primerjavi z zdravimi osebami, starimi od 19 do 45 let.
English: The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin.
Slovenian: Filmska obloga vsebuje: laktozo monohidrat (glejte poglavje 2 'Zdravilo Talmanco vsebuje laktozo'), hipromelozo (E464), titanov dioksid (E171) in triacetin.
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.
Slovenian: Tadalafil je > 10.000-krat močnejši za PDE5 kot za PDE1, PDE2 in PDE4, encime, ki se nahajajo v srcu, možganih, krvnih žilah, jetrih in drugih organih.
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.
Slovenian: bolniki s klinično pomembno okvaro aortne in mitralne zaklopke, bolniki s konstrikcijo perikarda, bolniki z restriktivno ali kongestivno kardiomiopatijo, bolniki z znatno poslabšanim delovanjem levega ventrikla, bolniki z življenjsko ogrožujočimi aritmijami, bolniki s simptomatsko boleznijo koronarne arterije, bolniki z neuravnano hipertenzijo.
English: Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Slovenian: Če se ob uporabi tadalafila pojavijo znaki pljučnega edema, je potrebno pomisliti na možnost povezanosti s PVOD.
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%).
Slovenian: Delež bolnikov z izboljšanjem v funkcijskem razredu po razvrstitvi po SZO do 16. tedna je bil pri skupinah, ki so jemale tadalafil in placebo, podoben (23% in 21%).
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)
Slovenian: Povejte zdravniku ali farmacevtu, če že jemljete: bosentan (drugo zdravljenje pljučne arterijske hipertenzije), nitrate (za zdravljenje bolečine v prsnem košu) antagoniste adrenergičnih receptorjev alfa za zdravljenje visokega krvnega tlak ali težav s prostato, riociguat, rifampicin (za zdravljenje bakterijskih okužbe), ketokonazol (za zdravljenje glivičnih okužbe), ritonavir (za zdravljenje okužbe z virusom HIV), tablete za erektilno disfunkcijo (zaviralce PDE5).
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Slovenian: Učinkovitost je bila dokazana pri idiopatski pljučni arterijski hipertenziji (IPAH) in PAH, povezani s sistemsko boleznijo veziva.
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.
Slovenian: Zaradi malo kliničnih izkušenj pri bolnikih z blago do zmerno cirozo jeter (razred A in B po ChildPughu) po dajanju enkratnega odmerka 10 mg se lahko premisli o začetnem odmerku 20 mg enkrat na dan.
English: Rare (may affect up to 1 in 1,000 people) sudden loss of vision.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - nenadna izguba vida.
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.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali in ki so se pojavili pri ≥ 10% bolnikov, ki so se zdravili s 40 mg tadalafila na dan, so bili glavobol, navzea, bolečina v hrbtu, dispepsija, zardevanje, mialgija, nazofaringitis in bolečina v udih.
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.
Slovenian: Tadalafil (20 mg) ni povečal srednjega znižanja krvnega tlaka, ki ga je povzročil alkohol (0,7 g/kg ali približno 180 ml 40% alkohola [vodke] pri 80-kg moškem), pri nekaterih osebah pa so opazili posturalno omotico in ortostatsko hipotenzijo.
English: These effects are unlikely to lead to a lack of fertility.
Slovenian: Mala verjetno je, da ti učinki povzročili zmanjšanje plodnosti.
English: This medicine does not require any special storage conditions.
Slovenian: Za shranjevaje zdravila niso potrebna posebna navodila.
English: Sudden cardiac death2, 5, Tachycardia2, 5
Slovenian: Srčne bolezni palpitacije nenadna srčna smrt2,5, tahikardija2,5
English: EXPIRY DATE EXP:
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP:
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.
Slovenian: Študija je vključevala 48-tedensko dvojno slepo obdobje, v katerem so bili bolniki randomizirani v skupine, ki so vsakodnevno prejemale tadalafil v odmerku 0,3 mg/kg, tadalafil v odmerku 0,6 mg/kg ali placebo.
English: Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171)
Slovenian: Filmska obloga laktoza monohidrat hipromeloza (2910/15 mPa s) (E464) titanov dioksid (E171) triacetin
English: The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
Slovenian: Povprečna razdalja, dosežena na 6-minutnem testu hoje (6MWD - 6-minute walk distance), ob začetku študije, je bila 343,6 metrov.
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.
Slovenian: V ključni, s placebom kontrolirani študiji tadalafila za zdravljenje PAH je tadalafil v odmerkih od 2,5 mg do 40 mg enkrat na dan dobivalo skupno 323 bolnikov, 82 bolnikov je dobivalo placebo.
English: The active substance is tadalafil.
Slovenian: Učinkovina je tadalafil.
English: If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you.
Slovenian: Če ste vzeli večji odmerek zdravila Talmanco, kot bi smeli Če vi ali kdor koli drug zaužije več tablet, kot bi morali, to takoj povejte zdravniku ali pojdite v bolnišnico.
English: PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
Slovenian: PVC/PE/PVdC-alu pretisni omoti v škatlah s po 28 ali 56 filmsko obloženimi tabletami.