natgillin/translations-raw huggingface dataset:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Patients should be informed not to take tadalafil with these medicinal products.
Bolesnicima treba napomenuti da ne uzimaju tadalafil s tim lijekovima.
What Talmanco is and what it is used for 2.
Što je Talmanco i za što se koristi 2.
At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Pri terapijskim koncentracijama se 94% tadalafila u plazmi vezuje za proteine.
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).
Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 January 2017
Datum prvog odobrenja: 09 siječanj 2017
Some medicines may be affected by Talmanco or they may affect how well Talmanco will work.
Talmanco može utjecati na neke lijekove ili oni mogu utjecati na djelovanje lijeka Talmanco.
Talmanco is a treatment for pulmonary arterial hypertension in adults.
Talmanco je lijek za liječenje plućne arterijske hipertenzije u odraslih.
What you need to know before you take Talmanco 3.
Što morate znati prije nego počnete uzimati Talmanco 3.
Talmanco with alcohol
Talmanco s alkoholom
BATCH NUMBER Lot:
4. BROJ SERIJE Lot:
if you have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION) if you have had a heart attack in the last 3 months if you have low blood pressure if you are taking riociguat.
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)) ako ste u posljednja 3 mjeseca imali srčani udar ako imate nizak krvni tlak ako uzimate riocigvat.
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.
Značajno poboljšanje (p <0,01) 6MWD-a dokazano je u 12. tjednu, kada su bolesnici zamoljeni da odgode uzimanje ispitivanog lijeka kako bi test odražavao najniže koncentracije djelatne tvari.
If you forget to take Talmanco
Ako ste zaboravili uzeti Talmanco
Vomiting, Gastroesophageal reflux
povraćanje, gastroezofagealni refluks
More than half (53.3%) of the patients in the study were receiving concomitant bosentan therapy.
Više od polovice (53,3%) bolesnika u ispitivanju istodobno je primalo bosentan.
swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
oticanje kapaka, bol u oku, crvene oči, srčani udar i moždani udar.
Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.
Manje od 0,0005% primijenjene doze ustanovljeno je u spermi zdravih ispitanika.
Elderly Dose adjustments are not required in elderly patients.
Nije potrebno prilagođavati dozu u starijih bolesnika.
If you experience any of the following side effects stop using the medicine and seek medical help immediately:
Ako primijetite neku od sljedećih nuspojava, prestanite uzimati lijek i odmah zatražite liječničku pomoć:
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 ubrzani srčani otkucaji, nepravilni otkucaji srca, srčani udar, moždani udar i iznenadna srčana smrt imala je poznate srčane tegobe prije uzimanja tadalafila.
The safety and efficacy of tadalafil in the paediatric population has not yet been established.
Sigurnost i djelotvornost tadalafila u pedijatrijskoj populaciji još nisu ustanovljene.
Do not breast-feed 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.
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Liječenje mora započeti i nadzirati isključivo liječnik s iskustvom u liječenju PAH-a.
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).
Budući da bi to moglo biti značajno za sve bolesnike izložene tadalafilu, bolesnicima treba savjetovati da u slučaju iznenadnog poremećaja vida prestanu uzimati lijek tadalafil i odmah se obrate liječniku (vidjeti dio 4.3).
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%).
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).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja tadalafila u jednoj ili više podskupina pedijatrijske populacije u liječenju plućne arterijske hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Three hundred and fifty seven (357) patients who completed the pivotal study entered a long-term extension study.
Tri stotine i pedeset sedam (357) bolesnika koji su završili pivotalno ispitivanje uključeno je u dugoročni produžetak ispitivanja.
28 film-coated tablets 28 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets
28 filmom obloženih tableta 28 x 1 filmom obložena tableta 56 filmom obloženih tableta 56 x 1 filmom obložena tableta
Tadalafil should not be used during breast-feeding.
Tadalafil se ne smije primjenjivati tijekom dojenja.
Uncommon (may affect up to 1 in 100 people) priapism, a prolonged and possibly painful erection after taking this medicine.
Manje često (mogu se javiti u do 1 na 100 osoba) prijapizam, dugotrajna te moguće i bolna erekcija nakon uzimanja ovoga lijeka.
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 (približno 36% doze).
Rare (may affect up to 1 in 1,000 people) sudden loss of vision.
Rijetko (mogu se javiti u do 1 na 1000 osoba) iznenadan gubitak vida
What you need to know before you take Talmanco
Što morate znati prije nego počnete uzimati Talmanco
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%).
These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data):
Ti događaji nisu zabilježeni u kliničkim ispitivanjima za plućnu arterijsku hipertenziju te im je stoga učestalost nepoznata (učestalost se ne može procijeniti iz dostupnih podataka):
What Talmanco contains
Što Talmanco sadrži
In haemodialysis patients, Cmax was 41% higher than that observed in healthy subjects.
U bolesnika na hemodijalizi je Cmax bio 41% veći nego u zdravih ispitanika.
INFORMATION IN BRAILLE Talmanco 20 mg
16. PODACI NA BRAILLEOVOM PISMU Talmanco 20 mg
Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Djelotvornost u bolesnika s plućnom arterijskom hipertenzijom (PAH) Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 405 bolesnika s plućnom arterijskom hipertenzijom.
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 uzmete više lijeka Talmanco nego što ste trebali 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.
Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Tadalafil je snažan i selektivan inhibitor fosfodiesteraze tipa 5 (PDE5), enzima odgovornog za razgradnju cikličkog gvanozin monofosfata (cGMP).
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).
Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Tadalafil također djeluje > 10 000 puta jače na PDE5 nego na PDE7 do PDE10.
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)
Obavijestite svog liječnika ili ljekarnika ako već uzimate: bosentan (drugi lijek za liječenje plućne arterijske hipertenzije) nitrate (za ublažavanje boli u prsnom košu) alfa-blokatore koji se koriste za liječenje visokog krvnog tlaka ili tegoba s prostatom riocigvat rifampicin (za liječenje bakterijskih infekcija) tablete ketokonazola (za liječenje gljivičnih infekcija) ritonavir (za liječenje HIV infekcije) tablete za erekcijsku disfunkciju (inhibitore PDE5).
Each film-coated tablet contains 237.9 mg lactose (234.5 mg as anhydrous and 3.4 mg as monohydrate).
Jedna filmom obložena tableta sadrži 237,9 mg laktoze (234,5 mg bezvodne i 3,4 mg u obliku hidrata).
PVC/PE/PVdC-Alu blisters in carton containing 28 and 56 film-coated tablets.
PVC/PE/PVdC-Al blisteri u kutijama koje sadrže 28 i 56 filmom obloženih tableta.
Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.
a vremenom se smanjuje čak i ako se liječenje nastavi.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake “Rok valjanosti” ili oznake “EXP”.
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).
Talmanco je indiciran u odraslih bolesnika za liječenje plućne arterijske hipertenzije (PAH) funkcionalnog stupnja II i III prema klasifikaciji SZO-a, u cilju poboljšanja tjelesne sposobnosti (vidjeti dio 5.1).
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.
P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Supstrati P-glikoproteina (npr. digoksin) Tadalafil (40 mg jedanput na dan) nije imao klinički značajnog učinka na farmakokinetiku digoksina.
EXPIRY DATE EXP:
3. ROK VALJANOSTI EXP:
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.
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 tadalafil prije nego upravljaju vozilom ili rukuju strojevima.
The filmcoating contains lactose monohydrate (see section 2 ‘Talmanco contains lactose'), hypromellose (E464), titanium dioxide (E171) and triacetin.
Film ovojnica sadrži laktozu hidrat (pogledajte dio 2 „Talmanco sadrži laktozu”), hipermelozu (E464), titanijev dioksid (E171) i triacetin.
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.
Ovaj lijek dostupan je u blister pakiranjima koja sadrže 28 ili 56 tableta i perforiranim jediničnu dozu blister pakiranjima koja sadrže 28 x 1 ili 56 x 1 tabletu.
The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies.
Djelotvornost i sigurnost istodobne primjene tadalafila i prostaciklina ili njegovih analoga nije ispitana u kontroliranim kliničkim ispitivanjima.
The overall frequency of discontinuation due to adverse events was low (tadalafil 11%, placebo 16%).
Ukupna je učestalost prekida liječenja zbog nuspojava bila niska (tadalafil 11%, placebo 16%).
6 Headache was the most commonly reported adverse reaction.
6 Najčešće prijavljena nuspojava bila je glavobolja.
Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Bolesnici koji su izgubili vid na jednom oku zbog nearterijske prednje ishemijske optičke neuropatije (NAION, engl. non-arteritic anterior ischaemic optic neuropathy), bez obzira na to je li ta epizoda povezana s prethodnim izlaganjem inhibitorima PDE5 (vidjeti dio 4.4).
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.
bolesnici s klinički značajnom bolešću aortnog i mitralnog zaliska bolesnici s konstrikcijom perikarda bolesnici s restriktivnom ili kongestivnom kardiomiopatijom bolesnici sa značajnom disfunkcijom lijeve klijetke bolesnici sa životno ugrožavajućim aritmijama bolesnici sa simptomatskom bolešću koronarnih arterija bolesnici s nekontroliranom hipertenzijom.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis (including nasal congestion, sinus congestion and rhinitis)
Poremećaji dišnog sustava, prsišta i sredoprsja nazofaringitis (uključujući kongestiju nosa, kongestiju sinusa i rinitis)
Reproductive system and breast disorders Increased uterine bleeding4
Poremećaji reproduktivnog sustava i dojki pojačano krvarenje iz maternice4
Hypromellose (2910/15 mPa·s) (E464) Titanium dioxide (E171)
Film ovojnica: laktoza hidrat hipromeloza (2910/15 mPa·s) (E464) titanijev dioksid (E171) triacetin
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.
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.
Tadalafil (20 mg) nije povećao prosječno sniženje krvnog tlaka izazvano alkoholom (0,7 g/kg ili približno 180 ml 40%-tnog alkohola [votka] u muškarca tjelesne težine 80 kg), no u nekih su ispitanika zabilježene posturalna omaglica i ortostatska hipotenzija.
Azole Antifungals (e.g. ketoconazole)
Azolni antimikotici (npr. ketokonazol)
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.
Antihipertenzivi (uključujući i blokatore kalcijevih kanala) Istodobna primjena doksazosina (4 i 8 mg na dan) i tadalafila (dnevna doza od 5 mg i 20 mg u jednoj dozi) značajno pojačava učinak ovog alfa-blokatora na sniženje krvnog tlaka.
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
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek ako imate: bilo kakvih srčanih tegoba osim plućne hipertenzije tegoba s krvnim tlakom neku nasljednu bolest oka poremećaj crvenih krvnih stanica (anemiju srpastih stanica) rak koštane srži (multipli mijelom) rak krvnih stanica (leukemiju) neku deformaciju penisa ili neželjenu ili dugotrajnu erekciju koja ne prolazi dulje od 4 sata ozbiljne tegobe s jetrom ozbiljne tegobe s bubrezima.
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.
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.
U pivotalnom placebom kontroliranom ispitivanju tadalafila u liječenju PAH-a ukupno su 323 bolesnika liječena tadalafilom u dozama od 2,5 mg do 40 mg jedanput na dan, dok su 82 bolesnika primala placebo.
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.
Najčešće prijavljene nuspojave, koje su se javile u ≥ 10% bolesnika u skupini koja je primala tadalafil u dozi od 40 mg, bile su glavobolja, mučnina, bol u leđima, dispepsija, crvenilo praćeno osjećajem užarenosti ili vrućine, mialgija, nazofaringitis i bol u udovima.
Prostacyclin and its analogues
Prostaciklin i njegovi analozi
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.
Neke su nuspojave prijavljene rijetko (mogu se javiti u do 1 na 1000 osoba): djelomično, privremeno ili trajno smanjenje ili gubitak vida na jednom ili oba oka i ozbiljna alergijska reakcija koja uzrokuje oticanje lica ili grla.
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.
Tadalafil (10 mg i 20 mg) nije imao klinički značajan učinak na izloženost (AUC) S-varfarinu ni R-varfarinu (supstrat CYP2C9), niti je utjecao na varfarinom izazvane promjene protrombinskog vremena.
Talmanco tablets contain lactose.
Tablete Talmanco sadrže laktozu.
A white, film-coated, round, biconvex, bevelled edge tablet (approximately 10.7 mm diameter) debossed with ‘M' on one side of the tablet and ‘TA20' on the other side.
Bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom (promjera približno 10,7 mm) s utisnutom oznakom „M” na jednoj strani tablete i „TA20” na drugoj strani tablete.
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).
Samo je uz primjenu tadalafila u dozi od 40 mg postignuta protokolom definirana razina značajnosti, pri čemu je medijan povećanja 6MWD-a korigiran za placebo iznosio 26 metara (p = 0,0004; 95% CI: 9,5; 44,0; prethodno definirana Hodges-Lehmanova metoda) (srednja vrijednost 33 metra, 95% CI: 15,2; 50,3).
Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Klinički izraz koji nije iz MedDRA terminologije, a obuhvaća izvješća o neuobičajenom/prekomjernom menstrualnom krvarenju kao što su menoragija, metroragija, menometroragija ili vaginalno krvarenje.
Nervous system disorders Headache
Poremećaji živčanog sustava glavobolja6
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
2. KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg tadalafila.
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.
Ostali sastojci u jezgri tablete su povidon, natrijev laurilsulfat, poloksamer 188, bezvodna laktoza (pogledajte dio 2 „Talmanco sadrži laktozu”), mikrokristalična celuloza (PH 101), umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat.
The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with tadalafil.
U sljedećoj su tablici navedene nuspojave prijavljene tijekom placebom kontroliranog kliničkog ispitivanja u bolesnika s PAH-om liječenih tadalafilom.
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).
Medijan povećanja 6MWD-a korigiran za placebo iznosio je 17 metara (p = 0,09; 95% CI: -7,1; 43,0; prethodno definirana Hodges-Lehmanova metoda) ( srednja vrijednost 23 metra, 95% CI: -2,4; 47,8) u onih bolesnika koji su primali tadalafil u dozi od 40 mg kao dodatak istodobno primijenjenom bosentanu (n = 39), a 39 metara (p < 0,01, 95% CI: 13,0; 66,0; prethodno definirana HodgesLehmanova metoda) (prosječno 44 metara, 95% CI: 19,7; 69,0) u onih bolesnika koji su primali samo tadalafil u dozi od 40 mg (n = 37).
Gastrointestinal disorders Nausea, Dyspepsia (including abdominal pain/discomfort3)
Poremećaji probavnog sustava mučnina, dispepsija (uključujući i bol/nelagodu u abdomenu3)
Salomone Pharma Ltd Tel: +356 21 22 01 74
V.J. Salomone Pharma Ltd Tel: +356 21 22 01 74