FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions reported were transient, and generally mild or moderate.
Slovenian: Poročani neželeni učinki so bili prehodni in v splošnem blagi ali zmerni.
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to CIALIS, to sexual activity, or to a combination of these or other factors.
Slovenian: Vendar pa ni mogoče dokončno potrditi, ali so omenjeni dogodki neposredno povezani s temi dejavniki tveganja, z zdravilom CIALIS, s spolno aktivnostjo ali s kombinacijo naštetih ali drugih dejavnikov.
English: - any deformation of your penis.
Slovenian: - kakršno koli deformacijo penisa.
English: Treatments should be initiated at minimal dosage and progressively adjusted.
Slovenian: Zdravljenje je treba začeti z najmanjšim odmerkom in ga postopno prilagajati.
English: The result of this is improved erectile function.
Slovenian: Rezultat tega je izboljšana erektilna funkcija.
English: This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown.
Slovenian: Za to zmanjšano izpostavljenost se lahko pričakuje, da bo zmanjšala učinkovitost tadalafila; obseg zmanjšanja učinkovitosti ni znan.
English: The tablets can be taken with or without food.
Slovenian: Tablete lahko jemljete s hrano ali brez nje.
English: The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.
Slovenian: Čas odmerjanja (zjutraj v primerjavi z zvečer) ni imel klinično pomembnih učinkov na stopnjo in obseg absorpcije.
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: Do not take CIALIS if you are already taking nitrates.
Slovenian: Ne vzemite zdravila CIALIS, če že jemljete nitrate.
English: The combination of tadalafil and doxazosin is not recommended.
Slovenian: Kombinacija tadalafila in doksazosina se ne priporoča.
English: Tell your doctor or pharmacist if you are already taking:
Slovenian: Obvestite svojega zdravnika ali farmacevta, če že jemljete:
English: - sudden loss of vision (frequency rare).
Slovenian: - nenadna izguba vida (pojavi se redko).
English: Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Slovenian: Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela že obstoječe srčnožilne dejavnike tveganja.
English: Children and adolescents CIALIS is not intended for use by children and adolescents under the age of 18.
Slovenian: Zdravilo CIALIS ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: - other medicines to treat high blood pressure.
Slovenian: - druga zdravila za zdravljenje visokega krvnega tlaka.
English: When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
Slovenian: Kadar predložitev PSUR in posodobitev RMP sovpadata, ju je treba predložiti istočasno.
English: Adverse events were similar to those seen at lower doses.
Slovenian: Neželeni dogodki so bili podobni tistim, opaženim pri manjših odmerkih.
English: There are limited data from the use of tadalafil in pregnant women.
Slovenian: Na voljo so omejeni podatki o uporabi tadalafila v nosečnosti.
English: Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet.
Slovenian: Vzemite svoj odmerek takoj, ko se spomnite, vendar ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: The patients should be informed not to take CIALIS in such combinations.
Slovenian: Bolnika je treba opozoriti naj ne jemlje zdravila CIALIS v takšnih kombinacijah.
English: This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).
Slovenian: To je skupina zdravil ("nitrati"), ki se uporabljajo pri zdravljenju angine pektoris ("bolečine za prsnico").
English: The maximum dose frequency is once per day.
Slovenian: Največja pogostnost odmerjanja je enkrat na dan.
English: Consequently the incidence of the adverse reactions listed in section 4.8 might be increased.
Slovenian: Posledično bi lahko bila incidenca neželenih učinkov, naštetih v poglavju 4.8, povečana.
English: A reduction in sperm was seen in some men.
Slovenian: Znižanje koncentracije sperme so opazili tudi pri nekaterih moških.
English: Most of these ECG abnormalities were not associated with adverse reactions.
Slovenian: Večina teh nepravilnosti EKG-ja, ni bila v povezavi z neželenimi učinki.
English: - have low blood pressure or uncontrolled high blood pressure.
Slovenian: - imate nizek krvni tlak ali neuravnan visok krvni tlak.
English: Drinking alcohol may temporarily lower your blood pressure.
Slovenian: Pitje alkohola lahko začasno zniža vaš krvni tlak.
English: If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Slovenian: Če imate takšno erekcijo, ki traja nepretrgoma več kot 4 ure, nemudoma pokličite zdravnika.
English: CIALIS may still be effective up to 36 hours after taking the tablet.
Slovenian: Zdravilo CIALIS je lahko učinkovito še do 36 ur po zaužitju tablete.
English: The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Slovenian: Povprečni volumen porazdelitve je približno 63 l, kar kaže, da se tadalafil razporeja po tkivih.
English: Do not store above 30°C.
Slovenian: Shranjujte pri temperaturi do 30˚C.
English: Antidiabetic medicinal products Specific interaction studies with antidiabetic medicinal products were not conducted.
Slovenian: Specifičnih študij medsebojnega delovanja z antidiabetičnimi zdravili niso izvedli.
English: - have serious heart disease or recently had a heart attack within the last 90 days.
Slovenian: - imate resno srčno obolenje ali ste v zadnjih 90 dneh preboleli srčni infarkt.
English: In addition, no changes in tadalafil concentrations were seen 3 hours after co-administration with alcohol.
Slovenian: Nadalje niso opažali sprememb koncentracij tadalafila 3 ure po sočasnem dajanju z alkoholom.
English: - a serious liver problem.
Slovenian: - resne težave z jetri.
English: Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
Slovenian: Odmerjanje enkrat na dan je lahko koristno za moške, ki pričakujejo spolno aktivnost dvakrat ali večkrat na teden.
English: Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Slovenian: Redko so poročali o delnem, začasnem ali trajnem poslabšanju ali izgubi vida na enem ali obeh očesih.
English: The role of transporters (for example p-glycoprotein) in the disposition of tadalafil is not known.
Slovenian: Vloga prenašalcev (na primer p-glikoproteina) pri razpoložljivosti tadalafila ni znana.
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 glede nosečnosti, embrio/fetalnega razvoja, poroda ali postnatalnega razvoja (glejte poglavje 5.3).
English: Elderly men
Slovenian: Starejši moški
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: Do not use this medicine after the expiry date which is 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: 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 kasnejši klinični študiji sta pokazali, da je ta učinek pri ljudeh malo verjeten, čeprav so pri nekaterih moških opažali zmanjšanje koncentracije sperme (glejte poglavji 5.1 in 5.3).
English: Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).
Slovenian: Alkohol so dajali na način, da bi čimbolj povečali absorpcijo alkohola (na tešče preko noči, brez hrane do preteka 2 ur po zaužitju alkohola).
English: Although this effect is minor and was of no clinical significance in this study, it should be considered when co-administering these medicinal products.
Slovenian: Čeprav je ta učinek manjši in v tej študiji ni bil klinično pomemben, ga je potrebno ob sočasnem dajanju teh zdravil upoštevati.
English: Take CIALIS with water every day at approximately the same time, either with or without food.
Slovenian: Zdravilo CIALIS vzemite z vodo vsak dan ob približno istem času, s hrano ali brez nje.
English: Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night.
Slovenian: Simptomi vključujejo težave pri začetku uriniranja, občutek nepopolno izpraznjenega mehurja in pogostejšo potrebo po uriniranju, tudi ponoči.
English: If you have a heart problem you should tell your doctor.
Slovenian: Če imate težave s srcem, morate to povedati zdravniku.
English: These effects are normally mild to moderate in nature.
Slovenian: Ti učinki so običajno blage do zmerne narave.
English: Ethinylestradiol and terbutaline
Slovenian: Etilenestradiol in terbutalin
English: In addition, an updated RMP should be submitted
Slovenian: Poleg tega je treba posodobljen RMP predložiti:
English: However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.
Slovenian: Vam je bil predpisan odmerek ene 20 mg tablete, saj je vaš zdravnik presodil, da je priporočeni odmerek 10 mg prešibek.
English: Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25˚C.
English: (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).
Slovenian: (1) Večina bolnikov je imela že obstoječe srčnožilne dejavnike tveganja (glejte poglavje 4.4).
English: Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
Slovenian: Zavedajte se, da spolna aktivnost prinaša možno tveganje za bolnike s srčnim obolenjem, ker še dodatno obremeni vaše srce.
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 izvedli na majhnem številu prostovoljcev, o omenjenih učinkih v primeru alfuzosina in tamsulosina niso poročali.
English: - are taking riociguat.
Slovenian: - jemljejo riociguat.
English: You may experience side effects described in section 4.
Slovenian: Morda boste občutili neželene učinke, opisane v poglavju 4.
English: Deutschland Lilly Deutschland GmbH
Slovenian: Lilly Deutschland GmbH
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately: - allergic reactions including rashes (frequency uncommon).
Slovenian: Če opazite kateregakoli od naslednjih neželenih učinkov, prenehajte uporabljati to zdravilo in nemudoma poiščite zdravniško pomoč: - alergijske reakcije, vključno z izpuščaji (pojavijo se občasno).
English: Start with the pill from the blister pack that corresponds with the day you start taking CIALIS.
Slovenian: Začnite s tableto iz pretisnega omota, ki ustreza dnevu, ko začnete jemati zdravilo CIALIS.
English: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Slovenian: Bolnike z erekcijami, ki trajajo 4 ure ali več, je potrebno opozoriti, naj nemudoma poiščejo zdravniško pomoč.
English: - rifampicin, erythromycin , clarithromycin or itraconazole.
Slovenian: - rifampicin, eritromicin, klaritromicin ali itrakonazol.
English: This effect of age is not clinically significant and does not warrant a dose adjustment.
Slovenian: Ta učinek starosti ni klinično pomemben in ne zahteva prilagoditve odmerka.
English: The recommended starting dose is one 10 mg tablet before sexual activity.
Slovenian: Priporočeni začetni odmerek je ena 10 mg tableta pred spolno aktivnostjo.
English: (3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products.
Slovenian: (3) O tem poročajo pogosteje, kadar tadalafil prejemajo bolniki, ki že jemljejo antihipertenzive.
English: In a rat prenatal and postnatal development study, the no observed effect dose was 30 mg/kg/day.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah je bil odmerek brez opaženega učinka 30 mg/kg/dan.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redkimi podedovanimi težavami intolerance za galaktozo, laponsko obliko pomanjkanja laktaze ali malabsorpcijo glukoze-galaktoze ne smejo jemati tega zdravila.
English: This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
Slovenian: To naj bi bila posledica kombiniranih učinkov nitratov in tadalafila na metabolno pot dušikovega oksida/cGMP.
English: - medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
Slovenian: - zdravila, kot so tablete s ketokonazolom (za zdravljenje glivičnih okužb) in zaviralce proteaze za zdravljenje aidsa ali okužbe z virusom HIV.
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.
Slovenian: Enkratne odmerke do 500 mg so dajali zdravim posameznikom, večkratne dnevne odmerke do 100 mg pa so dajali bolnikom.
English: This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Slovenian: Ta selektivnost za PDE5 pred PDE3 je pomembna, ker je PDE3 encim, povezan s kontraktilnostjo srca.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects.
Slovenian: Izpostavljenost tadalafilu (AUC) je bila pri bolnikih s sladkorno boleznijo približno 19 % nižja kot vrednost AUC za zdrave osebe.
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-sparing prostatectomy).
Slovenian: - odstranitev celotne prostate ali dela prostate, pri kateri so bili živci prostate prerezani (radikalna prostatektomija brez ohranjanja živcev).
English: You may take a CIALIS tablet at least 30 minutes before sexual activity.
Slovenian: Tableto zdravila CIALIS lahko zaužijete najmanj 30 minut pred spolno aktivnostjo.
English: In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects.
Slovenian: Pri sodelujočih v študiji, katerih krvni tlak ni bil urejen, je bilo znižanje večje, vendar to znižanje pri večini oseb ni bilo povezano s hipotenzivnimi simptomi.
English: Drinking alcohol may affect your ability to get an erection.
Slovenian: Pitje alkohola lahko vpliva na vašo sposobnost doseganja erekcije.
English: Haemodialysis contributes negligibly to tadalafil elimination.
Slovenian: Hemodializa zanemarljivo prispeva k izločanju tadalafila.
English: Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose.
Slovenian: Farmakokinetika tadalafila pri zdravih osebah je glede na čas in odmerek linearna.
English: - leukaemia (cancer of the blood cells).
Slovenian: - levkemijo (rakavo obolenje krvnih celic).
English: - are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
Slovenian: - jemljete kakršno koli obliko organskega nitrata ali donorje dušikovega oksida, kot je amilnitrit.
English: See section 4.
Slovenian: Glejte pogalvje 4.
English: Priapism and anatomical deformation of the penis
Slovenian: Priapizem in anatomske deformacije penisa
English: Before taking the tablets, tell your doctor if you have: - sickle cell anaemia (an abnormality of red blood cells).
Slovenian: Preden vzamete tablete, povejte zdravniku, če imate: - srpastocelično anemijo (nenormalnost rdečih krvničk).
English: If you are taking any form of nitrate or are unsure tell your doctor.
Slovenian: Če jemljete kakršno koli obliko nitrata ali o tem niste prepričani, povejte svojemu zdravniku.
English: One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in patients with both conditions.
Slovenian: Ena od teh študij je ocenjevala izboljšanji erektilne disfunkcije ter znakov in simptomov benigne hiperplazije prostate pri bolnikih z obema boleznima.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: de la Industria 30, 28108 Alcobendas, Madrid, Španija V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca,
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
Slovenian: Farmakodinamični/toksikološki podatki, ki so na voljo za živali, so pokazali, da se tadalafil izloča v mleko.
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: Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and 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 in predhodna izguba sluha v anamnezi), je treba bolnikom svetovati, naj v primeru nenadnega poslabšanja ali izgube sluha prenehajo z jemanjem tadalafila in poiščejo takojšnjo zdravniško pomoč.
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 prediatrični populaciji z DMD, ki prejema kortikosteroide.
English: The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.
Slovenian: Vzdrževanje učinka je bilo ocenjeno v odprti nadaljevalni fazi ene od študij, ki je pokazala, da je bilo izboljšanje skupnega rezultata na mednarodni lestvici prostatičnih simptomov, ki je bilo ugotovljeno pri 12 tednih, ohranjeno do 1 dodatnega leta zdravljenja z zdravilom CIALIS 5 mg.
English: Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction.
Slovenian: Farmakokinetika, ugotovljena s populacijskim pristopom pri bolnikih z erektilno disfunkcijo, je podobna farmakokinetiki pri osebah brez erektilne disfunkcije.
English: The appropriateness of continued use of the daily regimen should be reassessed periodically.
Slovenian: Ustreznost dolgotrajnega dnevnega odmerjanja je treba ponovno oceniti v rednih intervalih.
English: If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Slovenian: Če ste vzeli ali nameravate vzeti zdravilo CIALIS, se izogibajte čezmernemu pitju (raven alkohola v krvi 0,08 % ali več), ker lahko to poveča tveganje za omotico ob vstajanju.
English: Talk to your doctor for further information.
Slovenian: Za več informacij se pogovorite s svojim zdravnikom.
English: The improvements in total international prostate symptom score occurred as early as 1 week.
Slovenian: Izboljšanja skupnega rezultata na mednarodni lestvici prostatičnih simptomov so se pokazala že po 1 tednu.
English: Decreased or sudden hearing loss
Slovenian: Poslabšanje sluha ali nenadna izguba sluha
English: In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.
Slovenian: V takih okoliščinah se sme dajati nitrate samo pod skrbnim zdravstvenim nadzorom z ustreznim hemodinamskim spremljanjem.
English: Patients with diabetes
Slovenian: Bolniki s sladkorno boleznijo
English: This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5.
Slovenian: Ta ugotovitev je v skladu z nizko afiniteto tadalafila za PDE6 v primerjavi s PDE5.
English: Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
Slovenian: Študije so potrdile, da tadalafil ne zavira oziroma inducira izooblik CYP450, vključno s CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 in CYP2C19.
English: - chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon).
Slovenian: - bolečina v prsnem košu - ne uporabljajte nitratov, ampak nemudoma poiščite zdravniško pomoč (pojavi se občasno).
English: Some men taking CIALIS in clinical studies have reported dizziness.
Slovenian: Nekateri moški, ki so zdravilo CIALIS jemali v kliničnih študijah, so poročali o omotici.
English: Absolute bioavailability of tadalafil following oral dosing has not been determined.
Slovenian: Absolutna biološka uporabnost tadalafila po peroralnem odmerjanju ni bila določena.
English: Therefore there is the potential of drug interactions mediated by inhibition of transporters.
Slovenian: Zato obstaja možnost medsebojnih delovanj zdravil, ki jih posreduje zaviranje prenašalcev.
English: Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below.
Slovenian: Študije medsebojnega delovanja so bile opravljene z 10 mg in/ali 20 mg tadalafila, kot je prikazano spodaj.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Slovenian: Pred uvedbo kakršnegakoli zdravljenja za erektilno disfunkcijo naj zdravniki upoštevajo srčnožilno stanje svojih bolnikov, saj obstaja srčno tveganje, povezano s spolno aktivnostjo.
English: Effects of other substances on tadalafil
Slovenian: Učinki drugih učinkovin na tadalafil
English: Other side effects have been reported:
Slovenian: Poročali so tudi o drugih neželenih učinkih:
English: - priapsim, a prolonged and possibly painful erection after taking CIALIS (frequency rare).
Slovenian: - priapizem, podaljšana in morda boleča erekcija po jemanju zdravila CIALIS (pojavi se redko).
English: Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to CIALIS, before driving or using machines.
Slovenian: Kljub temu, da so bile pogostnosti poročanja o omotici v skupinah prejemanja placeba in tadalafila v kliničnih preskušanjih podobne, naj se bolniki pred vožnjo ali uporabo strojev zavedajo, kako se odzovejo na zdravilo CIALIS.
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.