natgillin/translations-raw huggingface dataset:
Sudden cardiac death2, 5, Tachycardia2, 5
iznenadna srčana smrt2, 5, tahikardija2, 5
Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Tadalafil nije utjecao na izloženost (AUC i Cmax) bosentanu ili njegovim metabolitima.
Effects were seen in dogs that might indicate impairment of fertility.
U pasa su primijećeni učinci koji bi mogli ukazivati na poremećaj plodnosti.
Do not breastfeed while taking these tablets as it is not known if the medicine passes into human breast milk.
Nemojte dojiti dok uzimate ove tablete jer nije poznato izlučuje li se lijek u majčino mlijeko.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Ukoliko se prijapizam ne liječi odmah, može doći do oštećenja tkiva penisa i trajnog gubitka potencije.
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.
Većina muškaraca, ali ne i svi oni u kojih su prijavljeni ubrzano kucanje srca, nepravilno kucanje srca, srčani udar, moždani udar i iznenadna srčana smrt imala je poznate srčane tegobe prije uzimanja tadalafila.
If you stop taking ADCIRCA Do not stop taking your tablets, unless advised otherwise by your doctor.
Nemojte prestati uzimati tablete, osim ako Vam liječnik nije savjetovao drugačije.
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.
Ako imate blage ili umjerene tegobe s jetrom ili bubrezima, liječnik će Vam možda savjetovati da uzmete samo jednu tabletu od 20 mg na dan.
This effect of age is not clinically significant and does not warrant a dose adjustment.
Ovaj utjecaj dobi nije klinički značajan i ne zahtijeva prilagodbu doze.
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 ADCIRCA and consult a physician immediately (see section 4.3).
Budući da bi to moglo biti značajno za sve bolesnike izložene tadalafilu, bolesnicima treba savjetovati da u slučaju iznenadnog poremećaja vida prestanu uzimati lijek ADCIRCA i odmah se obrate liječniku (vidjeti dio 4.3).
If you experience sudden decrease or loss of vision, contact your doctor immediately.
Ako osjetite iznenadno smanjenje ili gubitak vida, odmah se javite svom liječniku.
When dogs were treated there was reduced sperm development in the testes.
Kada je ovaj lijek davan psima, utvrđeno je smanjeno stvaranje sperme u testisima.
Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.
Iako nije poznato je li taj događaj izravno povezan s tadalafilom, ako primijetite slabljenje ili iznenadan gubitak sluha, odmah se javite svom liječniku.
The major circulating metabolite is the methylcatechol glucuronide.
Glavni metabolit u cirkuliraciji je metilkatehol-glukuronid.
The rate and extent of absorption of tadalafil are not influenced by food, thus ADCIRCA may be taken with or without food.
Hrana ne utječe na brzinu i opseg apsorpcije tadalafila, tako da se ADCIRCA može uzimati s hranom ili bez nje.
If you are taking any form of nitrate or are unsure tell your doctor.
Ako uzimate bilo koji oblik nitrata, ili niste sigurni, obavijestite svog liječnika.
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.
Međutim, post hoc analize pokazale su da se promjene od početnih vrijednosti parametara kardiopulmonalne hemodinamike u skupini liječenoj tadalafilom u dozi od 40 mg nisu značajno razlikovale u odnosu na placebo.
PDE5 inhibitors are also used for the treatment of erectile dysfunction in men.
Inhibitori PDE5 se koriste i za liječenje erektilne disfunkcije u muškaraca.
If you take more ADCIRCA than you should 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.
Ako ste Vi ili netko drugi uzeli više tableta nego što ste trebali, odmah obavijestite svog liječnika ili se javite u bolnicu i sa sobom ponesite lijek ili pakiranje lijeka.
Acetylsalicylic acid
Acetilsalicilatna kiselina
5 How to store ADCIRCA Contents of the pack and other information
Kako čuvati lijek ADCIRCA Sadržaj pakiranja i druge informacije
Therefore, caution is recommended in case of co-administration.
Stoga se u slučaju istodobne primjene preporučuje oprez.
ADCIRCA is a treatment for pulmonary arterial hypertension in adults.
ADCIRCA je lijek za liječenje plućne arterijske hipertenzije u odraslih.
Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0 %) and related to collagen vascular disease (23.5 %).
Etiologija plućne arterijske hipertenzije (PAH) pretežno je bila idiopatska (61,0%) ili povezana s kolagenozom krvnih žila (23,5%).
Eli Lilly Holdings Limited pārstāvniecība Latvijā
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā
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 %).
Prosječna dob svih bolesnika bila je 54 godine (raspon od 14 do 90 godina), a većina je bolesnika bila bijele rase (80,5%) i ženskog spola (78,3%).
Although other risk factors were present in some cases (such as age, diabetes, hypertension, previous hearing loss history and associated connective tissue diseases) patients should be advised to seek prompt medical attention in the event of sudden decrease or loss of hearing.
Iako su u nekim slučajevima bili prisutni i drugi faktori rizika (kao što su dob, šećerna bolest, hipertenzija, prethodan gubitak sluha u anamnezi i s njime povezani poremećaji vezivnog tkiva), bolesnicima treba savjetovati da odmah zatraže medicinsku pomoć u slučaju iznenadnog slabljenja ili gubitka sluha.
Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 4 hours after dosing.
Tadalafil se lako apsorbira nakon peroralne primjene, a prosječna maksimalna opažena koncentracija u plazmi (Cmax) se postiže 4 sata (medijan) nakon doziranja.
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).
rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
INFORMATION IN BRAILLE ADCIRCA 20 mg
16. PODACI NA BRAILLEOVOM PISMU ADCIRCA 20 mg
This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Ova selektivnost za PDE5 u odnosu na PDE3 važna je stoga što je PDE3 enzim uključen u kontraktilnost srca.
Major classes of antihypertensive medicinal products were studied either as monotherapy or as part of combination therapy.
Ispitivane su glavne skupine antihipertenzivnih lijekova, bilo u monoterapiji ili u sklopu kombinirane terapije.
Some side effects have been rarely reported: - Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat.
- djelomično, privremeno ili trajno smanjenje ili gubitak vida na jednom ili oba oka i ozbiljna alergijska reakcija koja uzrokuje oticanje lica ili grla.
Immune system disorders Hypersensitivity reactions5
Poremećaji imunološkog sustava reakcije preosjetljivosti5
- have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).
- ako ste ikada doživjeli gubitak vida - stanje koje se opisuje kao "očni udar" (nearterijska prednja ishemijska optička neuropatija (NAION, engl. non-arteritic anterior ischaemic optic neuropathy))
These effects are unlikely to lead to a lack of fertility.
Nije vjerojatno da bi ti učinci mogli dovesti do smanjene plodnosti.
Long-term treatment
Dugotrajno liječenje
Terbutaline
Terbutalin
Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil is not recommended in patients with severe renal impairment.
Zbog povećane izloženosti tadalafilu (AUC), ograničenog kliničkog iskustva i nemogućnosti da se na klirens utječe dijalizom, ne preporučuje se primjena tadalafila u bolesnika s teškim oštećenjem bubrega.
Pharmacokinetic studies have included subjects and patients from different ethnic groups, and no differences in the typical exposure to tadalafil have been identified.
U farmakokinetička su ispitivanja uključeni ispitanici i bolesnici iz različitih etničkih skupina i nisu utvrđene razlike u uobičajenoj izloženosti tadalafilu.
Patients were randomised to one of five treatment groups (tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg, or placebo).
Bolesnici su randomizirani u jednu od pet terapijskih skupina (tadalafil u dozi od 2,5 mg, 10 mg, 20 mg ili 40 mg, odnosno placebo).
Haemodialysis contributes negligibly to tadalafil elimination.
Hemodijaliza zanemarivo malo pridonosi eliminaciji tadalafila.
- rifampicin (to treat bacterial infections) - ketoconazole tablets (to treat fungal infections) - ritonavir (for HIV treatment) - tablets for erectile dysfunction (PDE5 inhibitors).
- rifampicin (za liječenje bakterijskih infekcija) - tablete ketokonazola (za liječenje gljivičnih infekcija) - ritonavir (za liječenje HIV infekcije)
Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.
6.5 Vrsta i sadržaj spremnika Aluminij/PVC/PE/PCTFE blisteri u kutijama sa 28 i 56 filmom obloženih tableta.
The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability.
Doza se može povećati na 40 mg jedanput na dan ovisno o djelotvornosti i podnošljivosti lijeka u pojedinog bolesnika.
ADCIRCA should not be used during breast feeding.
ADCIRCA se ne smije primjenjivati tijekom dojenja.
Allowed background therapy included bosentan (stable maintenance dose up to 125 mg twice daily) and chronic anticoagulation, digoxin, diuretics and oxygen.
Dopuštena osnovna terapija obuhvaćala je bosentan (stabilna doza održavanja do 125 mg dvaput na dan) te kroničnu primjenu antikoagulansa, digoksina, diuretika i kisika.
The majority of patients had a World Health Organization (WHO) Functional Class III (65.2 %) or II (32.1 %).
Većina je bolesnika imala bolest funkcionalnog stupnja III (65,2%) ili II (32,1%) prema klasifikaciji Svjetske zdravstvene organizacije (SZO).
Oral contraceptive pill
Oralni kontraceptivi
Priapism and anatomical deformation of the penis
Prijapizam i anatomska deformacija penisa
Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
Dostupni farmakodinamički/toksikološki podaci iz istraživanja na životinjama pokazuju da se tadalafil izlučuje u mlijeku.
In patients taking multiple antihypertensive medicinal products whose hypertension was not well controlled, greater reductions in blood pressure were observed compared to patients whose blood pressure was well controlled, where the reduction was minimal and similar to that in healthy subjects.
U bolesnika koji su uzimali više antihipertenziva, a hipertenzija im nije bila dobro kontrolirana, opaženo je veće sniženje krvnog tlaka nego u bolesnika s dobro kontroliranim krvnim tlakom, u kojih je sniženje bilo minimalno i podjednako onom u zdravih ispitanika.
Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Doziranje Preporučena doza je 40 mg (2 x 20 mg) jedanput na dan, s hranom ili bez nje.
Sudden decrease or loss of hearing has also been reported.
Prijavljeno je i iznenadno smanjenje ili gubitak sluha.
The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
6-minute walk distance, 6MWD) na početku ispitivanja bila je 343,6 metara.
The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.
Nisu ispitivane sigurnost i djelotvornost kombinacija tadalafila i drugih antagonista receptora endotelina-1.
- priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon).
- prijapizam, dugotrajna te moguće i bolna erekcija nakon uzimanja lijeka ADCIRCA (manje često).
The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Ukupna je učestalost prekida liječenja zbog nuspojava bila niska (ADCIRCA 11%, placebo 16%).
PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.
PDE5 je prevladavajuća fosfodiesteraza u plućnom krvožilju.
Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
nestabilna angina pektoris, ventrikularna aritmija, infarkt miokarda2
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Plućni vazodilatatori mogu značajno pogoršati kardiovaskularni status bolesnika s okluzivnom bolešću plućnih vena (OBPV).
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.
U bolesnika s plućnom hipertenzijom koji istodobno nisu primali bosentan prosječna izloženost tadalafilu u stanju dinamičke ravnoteže nakon doze od 40 mg bila je 26% veća nego u zdravih dobrovoljaca.
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).
Bolesnici su imali najmanje 12 godina i dijagnozu PAH-a koji je mogao biti idiopatski, povezan s kolagenskom bolešću, povezan s uporabom anoreksika, povezan s infekcijom virusom humane imunodeficijencije (HIV), povezan s defektom atrijskog septuma ili povezan s kirurškim popravkom, koji je postojao najmanje godinu dana, prirođenog sustavno-plućnog spoja (npr. defekta ventrikulskog septuma, otvorenog arterijskog kanala).
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.
Provedena su tri ispitivanja u muškaraca kako bi se procijenio potencijalni utjecaj svakodnevne primjene tadalafila u dozi od 10 mg (jedno 6-mjesečno ispitivanje) i 20 mg (jedno 6-mjesečno i jedno 9-mjesečno ispitivanje) na spermatogenezu.
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.
Bolesnici s poznatim nasljednim degenerativnim poremećajima mrežnice, uključujući retinitis pigmentosa, nisu bili uključeni u klinička ispitivanja te se primjena ovog lijeka u tih bolesnika ne preporučuje.
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).
Tadalafil treba primjenjivati uz oprez u bolesnika s anatomskim deformacijama penisa (poput angulacije, kavernozne fibroze ili Peyronijeve bolesti) i u bolesnika koji pate od nekih stanja koja mogu biti predispozicija za prijapizam (poput anemije srpastih stanica, multiplog mijeloma ili leukemije).
The active substance is tadalafil.
Djelatna tvar je tadalafil.
Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Mehanizam djelovanja Tadalafil je snažan i selektivan inhibitor fosfodiesteraze tipa 5 (PDE5), enzima odgovornog za razgradnju cikličkog gvanozin monofosfata (cGMP).
Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok valjanosti“ ili oznake „EXP“.
The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
Jedini farmakodinamički učinak bilo je malo (3,5 otkucaja u minuti) ubrzanje srčanog ritma.
357 patients from the placebo-controlled study entered a long-term extension study.
357 bolesnika iz placebom kontroliranog ispitivanja uključeno je u dugoročno produljenje ispitivanja.
There are limited data from the use of tadalafil in pregnant women.
Podaci o primjeni tadalafila u trudnica su ograničeni.
The time of dosing (morning versus evening after a single 10 mg administration) had no clinically relevant effects on the rate and extent of absorption.
Vrijeme doziranja (jedna doze od 10 mg ujutro ili navečer) nije imalo klinički značajnih učinaka na brzinu i opseg apsorpcije.
Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.
Farmakoterapijska skupina: Pripravci koji djeluju na mokraćni sustav, lijekovi koji se primjenjuju kod erektilne disfunkcije, ATK oznaka: G04BE08.
The usual dose is two 20 mg tablets taken once a day.
Uobičajena doza je dvije tablete od 20 mg jedanput na dan.
Doses studied were 20 mg and 40 mg once daily.
Ispitivane su doze od 20 mg i 40 mg jedanput na dan.
In addition, no changes in tadalafil concentrations were seen after co-administration with alcohol.
Nadalje, nakon istodobne primjene s alkoholom nisu opažene promjene u koncentracijama tadalafila.
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).
Tadalafil se pretežno izlučuje u obliku neaktivnih metabolita, uglavnom fecesom (približno 61% doze) te u manjoj mjeri mokraćom
Lilly France SAS Tél: +33-(0) 1 55 49 34 34
Lilly France S.A.S Tél: +33-(0)1 55 49 34 34
MARKETING AUTHORISATION NUMBER(S) EU/1/08/476/005-006
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/476/005-006
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na trudnoću, razvoj embrija i fetusa, okot i postnatalni razvoj
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 ADCIRCA, before driving or operating machinery.
Iako je u kliničkim ispitivanjima učestalost prijavljivanja omaglice bila podjednaka u skupinama koje su primale placebo odnosno tadalafil, bolesnici moraju biti svjesni kako reagiraju na lijek ADCIRCA prije nego upravljaju vozilom ili rukuju strojevima.
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.
Osim toga, tadalafil oko 700 puta snažnije djeluje na PDE5 nego na PDE6, enzim koji se nalazi u mrežnici i odgovoran je za fototransdukciju.
Syncope, Migraine5
sinkopa, migrena5
Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure.
Tadalafil ima sistemske vazodilatacijske učinke koji mogu rezultirati prolaznim sniženjem krvnog tlaka.
Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered.
Pojave li se kod primjene tadalafila znakovi plućnog edema, treba uzeti u obzir mogućnost pridruženog OBPV-a.
Contents of the pack and other information
Sadržaj pakiranja i druge informacije Što ADCIRCA sadrži
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 October 2008
Datum prvog odobrenja: 1. listopada 2008.
Cardiac disorders
Kardiovaskularni poremećaji
Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.
U rasponu doza od 2,5 do 20 mg izloženost tadalafilu (AUC) u zdravih ispitanika raste proporcionalno dozi.
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).
Poboljšanja kod primjene tadalafila u dozi od 40 mg u odnosu na placebo uočena su i u američkim i britanskim rezultatima upitnika EuroQol (EQ-5D), koji obuhvaća komponente mobilnosti, brige o sebi, uobičajenih aktivnosti, boli/nelagode, tjeskobe/depresije, te na vizualno analognoj skali (VAS).
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.
Pripada skupini lijekova koji se zovu inhibitori fosfodiesteraze tipa 5 (PDE5), a djeluju tako što pomažu opustiti krvne žile u plućima te se time poboljšava dotok krvi u pluća.
In the pregnant rat the AUC for calculated free active substance at this dose was approximately 18 times the human AUC at a 20 mg dose.
U skotnih je štakorica pri toj dozi AUC izračunate slobodne djelatne tvari bio približno 18 puta veći od AUC-a u ljudi pri dozi od 20 mg.
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.
U bolesnika koji se istodobno liječe antihipertenzivima, tadalafil u dozi od 20 mg može izazvati sniženje krvnog tlaka, koje je (s izuzetkom doksazosina - vidjeti prethodni odlomak) u pravilu malo i nije vjerojatno da će biti klinički značajno.
The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance (6MWD).
Primarna mjera ishoda za djelotvornost bila je promjena od početne udaljenosti prijeđene za 6 minuta hodanja (6MWD) u 16. tjednu.
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.
Zdravi stariji ispitanici (65 godina i stariji) imali su manji klirens tadalafila nakon peroralne primjene doze od 10 mg, što je rezultiralo 25% većom izloženošću (AUC) u odnosu na zdrave ispitanike u dobi od 19 do 45 godina.
ADCIRCA contains lactose monohydrate.
ADCIRCA sadrži laktozu hidrat.
In patients with mild to moderate renal impairment a starting dose of 20 mg once per day is recommended.
U bolesnika s blagim do umjerenim oštećenjem bubrega preporučuje se početna doza od 20 mg jedanput na dan.
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).
Incidencija kliničkog pogoršanja do 16. tjedna bila je manja u bolesnika liječenih tadalafilom u dozi od 40 mg (5%; 4 od 79 bolesnika) nego u bolesnika koji su primali placebo (16%; 13 od 82 bolesnika).
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.
Kod primjene tadalafila u dozama od 20 mg i 40 mg jedanput na dan koncentracije u plazmi u stanju dinamičke ravnoteže postižu se u roku od 5 dana, a izloženost je oko 1,5 puta veća nego nakon primjene jedne doze.
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.
placebom kontrolirano ispitivanje tadalafila s tri paralelne skupine provedeno je u 331 dječaka s DMD-om u dobi od 7 do 14 godina koji su istodobno primali terapiju kortikosteroidima.