FrancophonIA/ELRC3.0 huggingface dataset:
English: The result of this is an improved ability to do physical activity.
Slovenian: Posledica je izboljšanje sposobnosti za telesno dejavnost.
English: (2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Slovenian: (2) Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela predhodno prisotne srčno-žilne dejavnike tveganja.
English: This effect lasts at least twelve hours and may be symptomatic, including syncope.
Slovenian: Ta učinek traja vsaj dvanajst ur in je lahko simptomatski, vključno s sinkopo.
English: - have low blood pressure.
Slovenian: - imate nizek krvni tlak,
English: A risk to the breastfed child cannot be excluded.
Slovenian: Tveganja za otroka, ki se doji, ni mogoče izključiti.
English: - sudden loss of vision (rarely reported).
Slovenian: • nenadna izguba vida (o tej so redko poročali).
English: Currently available data are described in section 5.1.
Slovenian: ki so trenutno na voljo, so opisani v poglavju 5.1.
English: For those patients for which there are data, the survival rate at 1 year is 96.4 %.
Slovenian: Pri bolnikih, pri katerih so bili podatki na voljo, je bilo preživetje po enem letu 96,4 %.
English: Date of latest renewal: 1 October 2013
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 1. oktober 2013
English: It is not possible to determine whether these events were related directly to tadalafil.
Slovenian: Ni možno ugotoviti, ali so bili ti učinki neposredno povezani s tadalafilom.
English: Severe hypotension (<90/50 mm Hg).
Slovenian: Huda hipotenzija (< 90/50 mm Hg)
English: Patients should be informed not to take ADCIRCA with these medicinal products.
Slovenian: Bolnike je potrebno obvestiti, naj zdravila ADCIRCA ne jemljejo skupaj s temi zdravili.
English: Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose.
Slovenian: Odmerek vzemite čim prej, ko se spomnite, če je minilo manj kot 8 ur, odkar bi morali vzeti svoj odmerek.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 1 October 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 1. oktober 2008
English: Acute myocardial infarction within the last 90 days.
Slovenian: Akutni miokardni infarkt v zadnjih 90 dneh.
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: 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: 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).
Slovenian: Študije na živalih ne kažejo direktnih ali indirektnih škodljivih učinkov zvezi z nosečnostjo, embrio/fetalnega razvojem, porodom ali postnatalnim razvojem (glejte poglavje 5.3).
English: Therefore, this combination is not recommended (see section 4.4).
Slovenian: Omenjena kombinacija zato ni priporočljiva (glejte poglavje 4.4).
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, takoj kontaktirajte zdravnika.
English: A reduction in sperm was seen in some men.
Slovenian: Zmanjšanje koncentracije sperme so opazili tudi pri nekaterih moških.
English: - chest pain - do not use nitrates, but seek immediate medical assistance (frequency common).
Slovenian: • bolečina v prsih - ne uporabljajte nitratov, ampak poiščite zdravniško pomoč (pojavi se pogosto).
English: Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.
Slovenian: Glavobol se lahko pojavi na začetku zdravljenja in se sčasoma zmanjša, če bolnik nadaljuje z zdravljenjem.
English: If you forget to take ADCIRCA
Slovenian: Če ste pozabili vzeti zdravilo ADCIRCA
English: This interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Slovenian: Ta interakcija je trajala več kot 24 ur in je 48 ur po zadnjem odmerku tadalafila ni bilo več mogoče zaslediti.
English: The adverse reactions reported were transient, and generally mild or moderate.
Slovenian: Neželeni učinki, o katerih so poročali, so bili prehodni in večinoma blagi do zmerni.
English: Avda de la Industria 30 28108 Alcobendas (Madrid) Spain
Slovenian: Avda de la Industria 30 28108 Alcobendas (Madrid) Španija
English: The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Slovenian: Skupna pogostnost prenehanja zaradi neželenih učinkov je bila nizka (ADCIRCA 11 %, placebo 16 %).
English: Stevens-Johnson Syndrome, Exfoliative dermatitis
Slovenian: StevensJohnsonov sindrom, eksofoliativni dermatitis
English: Children and adolescents ADCIRCA is not indicated for use by children and adolescents under the age of 18.
Slovenian: Zdravilo ADCIRCA ni namenjeno zdravljenju otrok in mladostnikov, mlajših od 18 let.
English: There were no clinically relevant differences in Cmax compared to healthy volunteers.
Slovenian: Pri vrednostih Cmax ni prišlo so klinično pomembnih razlik v primerjavi z zdravimi prostovoljci.
English: - are taking riociguat.
Slovenian: - jemljete riociguat.
English: Adverse reactions were similar to those seen at lower doses.
Slovenian: Neželeni učinki so bili podobni tistim, opaženim pri manjših odmerkih.
English: The clinical relevance of this finding is uncertain.
Slovenian: Klinična pomembnost tega je negotova.
English: As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy.
Slovenian: Zaradi previdnosti je bolje, da se uporabi tadalafila med nosečnostjo izognemo.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Slovenian: Zdravljenje sme uvesti in nadzorovati le zdravnik, ki ima izkušnje z zdravljenjem PAH.
English: Other medicines and ADCIRCA
Slovenian: Druga zdravila in zdravilo ADCIRCA
English: Therefore, the combination of tadalafil and doxazosin is not recommended.
Slovenian: Kombinacija tadalafila in doksazosina se zato ne priporoča.
English: See Section 4.
Slovenian: Glejte poglavje 4.
English: Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).
Slovenian: Dve sledeči klinični študiji sta pokazali, da takšnega učinka pri ljudeh ni, čeprav so pri nekaterih moških opazili zmanjšanje koncentracije sperme (glejte poglavji 5.1 in 5.3).
English: Elderly patients Dose adjustments are not required in elderly patients.
Slovenian: Starejši bolniki Odmerka pri starejših bolnikih ni potrebno prilagajati.
English: They are in the shape of almonds and have "4467" marked on one side.
Slovenian: So v obliki mandlja in imajo na eni strani oznako "4467".
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: Of these, 311 patients had been treated with tadalafil for at least 6 months and 293 for 1 year (median exposure 365 days; range 2 days to 415 days).
Slovenian: Od teh se je 311 bolnikov s tadalfilom zdravilo najmanj 6 mesecev, 293 pa 1 leto (mediana izpostavljenost je bila 365 dni, razpon od 2 dni do 415 dni).
English: The improvement in walk distance was apparent from 8 weeks of treatment.
Slovenian: Izboljšanje 6MWD je bilo opazno po 8 tednih zdravljenja.
English: Icepharma hf.
Slovenian: Ísland Icepharma hf.
English: Adverse reaction data are limited in patients over 75 years of age.
Slovenian: Podatki o neželenih učinkih pri bolnikih nad 75 let so omejeni.
English: The tablets can be taken with or without food.
Slovenian: Zdravilo ADCIRCA lahko vzamete s hrano ali brez nje.
English: What ADCIRCA is and what it is used for What you need to know before you take ADCIRCA How to take ADCIRCA
Slovenian: Kaj je zdravilo ADCIRCA in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ADCIRCA Kako jemati zdravilo ADCIRCA
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 breastfeed 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: 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: - priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon).
Slovenian: • priapizem, podaljšana in morda boleča erekcija po jemanju zdravila ADCIRCA (pojavi se redko).
English: 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.
Slovenian: Čeprav so bili v določenih primerih prisotni drugi dejavniki tveganja (npr. starost, sladkorna bolezen, hipertenzija, predhodna izguba sluha v anamnezi in povezane bolezni veznega tkiva), je treba bolnikom svetovati, naj v primeru nenadnega poslabšanja ali izgube sluha poiščejo takojšnjo zdravniško pomoč.
English: In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Slovenian: V študijah interakcij, ki so jih na majhnem številu zdravih prostovoljcev opravili z alfuzocinom ali tamsulozinom, o teh učinkih niso poročali.
English: Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.
Slovenian: Pretisni omoti aluminij/PVC/PE/ PCTFE v škatlah s po 28 ali 56 filmsko obloženimi tabletami.
English: Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake 'EXP'.
English: The results suggest a lower clearance of tadalafil in patients with pulmonary hypertension compared to healthy volunteers.
Slovenian: Rezultati kažejo na nižji očistek tadalafila pri bolnikih s pljučno hipertenzijo v primerjavi z zdravimi prostovoljci.
English: ADCIRCA has been shown to increase the effects of these medicines.
Slovenian: Za zdravilo ADCIRCA je bilo namreč ugotovljeno, da učinke teh zdravil poveča.
English: Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work.
Slovenian: Zdravilo ADCIRCA lahko vpliva na nekatera zdravila ali pa lahko zdravila vplivajo na delovanje zdravila ADCIRCA.
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 ADCIRCA 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 zdravilo ADCIRCA in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4.3).
English: ADCIRCA with alcohol
Slovenian: Zdravilo ADCIRCA skupaj z alkoholom
English: ADCIRCA has negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo ADCIRCA ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja s stroji.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/476/005-006
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/476/005-006
English: 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.
Slovenian: Čas odmerjanja (zaužitje enkratnega odmerka 10 mg zjutraj v primerjavi z zvečer) ni imel klinično pomembnih učinkov na stopnjo in obseg absorpcije.
English: PDE5 inhibitors are also used for the treatment of erectile dysfunction in men.
Slovenian: Zaviralci PDE5 se uporabljajo tudi za zdravljenje erektilne disfunkcije pri moških.
English: Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor.
Slovenian: Če ste noseči, zdravila ADCIRCA ne uporabljajte, razen če je to nujno potrebno in ste se o tem pogovorili s svojim zdravnikom.
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: Treatments for erectile dysfunction
Slovenian: Zdravljenje erektilne disfunkcije
English: The mean volume of distribution is approximately 77 l at steady state, indicating that tadalafil is distributed into tissues.
Slovenian: Povprečni volumen porazdelitve v stanju dinamičnega ravnovesja je približno 77 l, kar kaže, da se tadalafil razporeja po tkivih.
English: Three hundred and fifty seven (357) patients who completed the pivotal study entered a long-term extension study.
Slovenian: Tristo sedeminpetdeset (357) bolnikov, ki so dokončali to ključno študijo, je bilo vključenih v dolgoročno podaljšano študijo.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnemm neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: You may experience any of the side effects described in section 4.
Slovenian: Lahko se pojavijo kateri koli neželeni učinki, opisani v poglavju 4.
English: 357 patients from the placebo-controlled study entered a long-term extension study.
Slovenian: 357 bolnikov iz s placebom kontrolirane študije je bilo vključenih v dolgoročno podaljšano študijo.
English: If you experience sudden decrease or loss of vision, contact your doctor immediately.
Slovenian: Če doživite nenadno poslabšanje ali izgubo vida, se takoj obrnite na zdravnika.
English: Vomiting, Gastroesophageal reflux
Slovenian: bruhanje, gastroezofagealni refluks
English: If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Slovenian: ADCIRCA, se izogibajte prekomernemu pitju (več kot 5 enot alkohola), saj lahko to vpliva na tveganje za omotico pri vstajanju.
English: Patients were randomised to one of five treatment groups (tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg, or placebo).
Slovenian: Bolnike so randomizirali v eno od petih skupin zdravljenja: (2,5 mg, 10 mg, 20 mg, 40 mg tadalafila ali placebo).
English: INFORMATION IN BRAILLE ADCIRCA 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI ADCIRCA 20 mg
English: Haemodialysis contributes negligibly to tadalafil elimination.
Slovenian: Hemodializa zanemarljivo prispeva z izločanju tadalafila.
English: Eli Lilly Holdings Limited pārstāvniecība Latvijā
Slovenian: Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā
English: Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients with erectile dysfunction.
Slovenian: Enkratne odmerke do 500 mg so dajali zdravim posameznikom, večkratne dnevne odmerke do 100 mg pa so dajali bolnikom z erektilno disfunkcijo.
English: Do NOT take a double dose to make up for the one that you have forgotten.
Slovenian: NE vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Slovenian: Tadalafil ni vplival na biološko uporabnost (AUC in Cmax) bosentana in njegovih metabolitov.
English: Major classes of antihypertensive medicinal products were studied either as monotherapy or as part of combination therapy.
Slovenian: V študijo so bili vključeni poglavitni razredi antihipertenzivnih zdravil; kot monoterapija in kot del kombinirane terapije.
English: 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.
Slovenian: Če ste vzeli večji odmerek zdravila ADCIRCA, kot bi smeli Če vi ali kdor koli drug zaužije več tablet, kot bi morali, to takoj povejte zdravniku ali pojdite v bolnišnico.
English: These effects are unlikely to lead to a lack of fertility.
Slovenian: Malo verjetno je, da bi ti učinki povzročili zmanjšanje plodnosti.
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).
Slovenian: Bolniki so bili stari vsaj 12 let in so imeli diagnozo PAH, ki je bila idiopatska, povezana z vaskularno sistemsko boleznijo vezivnega tkiva, povezana z uporabo anoreksigena, povezana z okužbo s človeškim virusom imunske pomanjkljivost (HIV), povezana z z atrijskim septalnim defektom ali pa v povezavi s kirurško popravo kongenitalnega sistemsko-pljučnega šanta, ki je bila opravljena pred ne manj kot enim letom (npr. ventrikularni septalni defekt, patent ductus arteriosus).
English: Changes in the Borg dyspnoea score were small and non-significant with both placebo and tadalafil 40 mg.
Slovenian: Spremembe v rezultatu dispneje po Borgu so bile majhne in nepomembne, tako pri placebu kot pri 40 mg tadalafila.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
Slovenian: Farmakodinamski/toksikološki podatki pri živalih, ki so na voljo, so pokazali, da se tadalafil izloča v mleko.
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 jetri ali ledvicami, vam bo zdravnik morda svetoval, da vzamete le eno 20 mg tableto na dan. Pogoltnite celi tableti z nekaj vode.
English: The safety and efficacy of ADCIRCA in the paediatric population has not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila ADCIRCA pri pediatrični populaciji še nista bili dokazani.
English: In addition, no changes in tadalafil concentrations were seen after co-administration with alcohol.
Slovenian: Prav tako niso opazili sprememb koncentracij tadalafila ob sočasnem jemanju z alkoholom.
English: ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.
Slovenian: Zdravilo ADCIRCA 20 mg je na voljo v pretisnih omotih z 28 ali 56 tabletami.
English: Orange and almond shaped film-coated tablets, marked "4467" on one side.
Slovenian: Filmsko obložene tablete oranžne barve in mandljeve oblike, z oznako “4467” na eni strani.
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.
Slovenian: Farmakoterapevtska skupina: Zdravila za bolezni sečil, Zdravila za zdravljenje erektilne disfunkcije, Oznaka ATC: G04BE08.
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 tadalafil 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: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Slovenian: nestabilna angina pektoris, ventrikularna aritmija, miokardni infarkt2
English: Effects were seen in dogs that might indicate impairment of fertility.
Slovenian: Pri psih so bili opaženi učinki, ki morda kažejo na zmanjšanje plodnosti.
English: The rate and extent of absorption of tadalafil are not influenced by food, thus ADCIRCA may be taken with or without food.
Slovenian: Ker hrana ne vpliva na stopnjo in obseg absorpcije tadalafila, se lahko zdravilo ADCIRCA vzame s hrano ali brez nje.
English: Cardiopulmonary hemodynamics was performed in 93 patients.
Slovenian: Srčno-pljučni pretok krvi je bil izmerjen pri 93 bolnikih.
English: Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Slovenian: V večini primerov so bili rezultati med različnimi podskupinami glede na starost, spol, etiologijo PAH in začetni funkcijski razred po razvrstitvi SZO ter 6MWD skladni.
English: The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
Slovenian: Edini farmakodinamični učinek je bil manjše zvišanje srčne frekvence (za 3,5 utripa na minuto).
English: Doses studied were 20 mg and 40 mg once daily.
Slovenian: Proučevali so odmerke 20 mg in 40 mg enkrat na dan.
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily.
Slovenian: Pri moških so izvedli tri študije za ugotavljanje možnega učinka tadalafila v odmerku 10 mg (ena 6mesečna študija) in 20 mg (ena 6-mesečna in ena 9-mesečna študija), ki so ga dajali na dan, na spermatogenezo.
English: 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.
Slovenian: - delna, začasna ali stalna izguba vida na eno ali obe očesi in resno alergijsko reakcijo, ki povzroči otekanje obraza ali grla.
English: Terbutaline
Slovenian: Terbutalin
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: ADCIRCA contains lactose If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo ADCIRCA vsebuje laktozo Če veste, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila obrnite na zdravnika.
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 ADCIRCA, before driving or operating machinery.
Slovenian: 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 zdravilo ADCIRCA.