FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS 100 mg Dose 28 day pack: 56 capsules (4 blister cards of 7 x 20 mg capsules and 7 x 80 mg capsules) for the 100 mg daily dose for a 28 day supply.
Slovenian: 28-dnevno pakiranje: 56 kapsul (4 pretisne zgibanke s: 7 x 20 mg kapsulami in 7 x 80 mg kapsulami) za odmerek 100 mg na dan, zaloga za 28 dni.
English: Tel: +372 60 15 540 Ελλάδα, Κύπρος, Malta
Slovenian: Tel: +372 60 15 540
English: PHARMACEUTICAL FORM AND CONTENTS 140 mg Dose 28 day pack: 112 capsules (4 blister cards of 21 x 20 mg capsules and 7 x 80 mg capsules) for the 140 mg daily dose for a 28 day supply.
Slovenian: 28-dnevno pakiranje: 112 kapsul (4 pretisne zgibanke z: 21 x 20 mg kapsulami in 7 x 80 mg kapsulami) za odmerek 140 mg na dan, zaloga za 28 dni.
English: • Swollen lymph glands
Slovenian: • otekle bezgavke
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 140 mg dose (WITHOUT BLUE BOX)
Slovenian: PRETISNA ZGIBANKA 28-DNEVNO PAKIRANJE, odmerek 140 mg (BREZ BLUE-BOXA)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena trda kapsula vsebuje kabozantinib (S)-malat v količini, ki ustreza 20 mg kabozantiniba.
English: Eye disorders vision blurred cataract, conjunctivitis
Slovenian: Očesne bolezni zamegljen vid katarakta, konjunktivitis
English: 20 mg and 80 mg
Slovenian: trda kapsula 20 mg in 80 mg 100 mg odmerek
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD OF 28 DAY PACK, 100 mg dose (WITHOUT BLUE BOX)
Slovenian: PRETISNA ZGIBANKA 28-DNEVNO PAKIRANJE, odmerek 100 mg (BREZ BLUE-BOXA)
English: 140 mg/day dose
Slovenian: 140 mg/dan, zaloga za 28 dni)
English: • Joint pain, muscle spasms
Slovenian: • bolečine v sklepih, mišični spazmi
English: Name and address of the manufacturer responsible for batch release
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Shellac
Slovenian: Hampshire
English: Wound complications have been observed with cabozantinib.
Slovenian: Pri uporabi kabozantiniba so opazili zaplete z ranami.
English: Haemorrhage
Slovenian: MedDRA
English: • Facial pain
Slovenian: • možganska kap
English: - sudden loss of vision (frequency rare).
Slovenian: - nenadna izguba vida (pogostnost redka).
English: - have low blood pressure or uncontrolled high blood pressure.
Slovenian: - imate nizek krvni tlak ali nekontroliran visok krvni tlak.
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to Tadalafil Lilly, 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 Tadalafil Lilly, s spolno aktivnostjo ali s kombinacijo naštetih ali drugih dejavnikov.
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 (pogostnost neznana).
English: Antidiabetic medicinal products Specific interaction studies with antidiabetic medicinal products were not conducted.
Slovenian: Specifične študije medsebojnega delovanja z antidiabetičnimi zdravili niso bile opravljene.
English: de la Industria 30, Alcobendas, 28108 Madrid, Spain
Slovenian: de la Industria 30, Alcobendas, 28108 Madrid, Španija
English: However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg 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: The patients should be informed not to take Tadalafil Lilly in such combinations.
Slovenian: Bolnika je treba opozoriti naj ne jemlje zdravila Tadalafil Lilly v takšnih kombinacijah.
English: Do not take Tadalafil Lilly if you are already taking nitrates.
Slovenian: Ne vzemite zdravila Tadalafil Lilly, če že jemljete nitrate.
English: Take Tadalafil Lilly with water every day at approximately the same time, either with or without food.
Slovenian: Zdravilo Tadalafil Lilly vzemite z vodo vsak dan ob približno istem času, s hrano ali brez nje.
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 amil nitrit.
English: Children and adolescents Tadalafil Lilly is not intended for use by children and adolescents under the age of 18.
Slovenian: Zdravilo Tadalafil Lilly ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.
Slovenian: Zdravilo Tadalafil Lilly je lahko učinkovito še do 36 ur po zaužitju tablete.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects.
Slovenian: Izpostavitev tadalafilu (AUC) je bila pri bolnikih s sladkorno boleznijo približno 19 % nižja kot vrednost AUC za zdrave osebe.
English: - priapism, a prolonged and possibly painful erection after taking Tadalafil Lilly (frequency rare).
Slovenian: - priapizem, podaljšana in morda boleča erekcija po jemanju zdravila Tadalafil Lilly (pogostnost redka).
English: Start with the pill from the blister pack that corresponds with the day you start taking Tadalafil Lilly.
Slovenian: Začnite s tableto iz pretisnega omota, ki ustreza dnevu, ko začnete jemati zdravilo Tadalafil Lilly.
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 jemati tadalafil in poiščejo takojšnjo zdravniško pomoč.
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 Tadalafil Lilly 5 mg.
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 Tadalafil Lilly 5 mg.
English: If you have taken or are planning to take Tadalafil Lilly, 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 Tadalafil Lilly, se izogibajte čezmernemu pitju (raven alkohola v krvi 0,08 % ali več), ker lahko to poveča tveganje za omotico ob vstajanju.
English: You may take a Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Slovenian: Tableto zdravila Tadalafil Lilly lahko zaužijete najmanj 30 minut pred spolno aktivnostjo.
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 rezltati o varnosti so bili v tej študiji na splošno skladni z znanim varnostnim profilom tadalafila in z neželenimi učinki, pričakovanimi v pediatrični populaciji z DMD, ki prejema kortikosteroide.
English: Once a day dosing of Tadalafil Lilly 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: Tadalafil Lilly was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia.
Slovenian: Zdravilo Tadalafil Lilly je bilo proučevano v 4 kliničnih študijah, ki so trajale 12 tednov in so vključevale prek 1500 bolnikov z znaki in simptomi benigne hiperplazije prostate.
English: With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.
Slovenian: Glede na te študije medsebojnega delovanja, pri katerih je bil uporabljan samo odmerek 10 mg tadalafila, klinično pomembnih medsebojnih delovanj pri višjih odmerkih ni mogoče popolnoma izključiti.
English: Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with Tadalafil Lilly for benign prostatic hyperplasia.
Slovenian: Ker imata benigna hiperplazija prostate in rak prostate lahko enake simptome, vas bo vaš zdravnik pred začetkom zdravljenja vaše benigne hiperplazije prostate z zdravilom Tadalafil Lilly pregledal za rak prostate.
English: Some men taking Tadalafil Lilly in clinical studies have reported dizziness.
Slovenian: Nekateri moški, ki so zdravilo Tadalafil Lilly jemali v kliničnih študijah, so poročali o omotici.
English: Tadalafil Lilly and other treatments for erectile dysfunction The safety and efficacy of combinations of Tadalafil Lilly and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Slovenian: Zdravilo Tadalafil Lilly in druga zdravljenja erektilne disfunkcije Varnosti in učinkovitosti kombinacij zdravila Tadalafil Lilly in drugih zaviralcev PDE5 ali drugih zdravljenj za erektilno disfunkcijo niso preučevali.
English: If you experience sudden decrease or loss of vision, stop taking Tadalafil Lilly and contact your doctor immediately.
Slovenian: Če doživite nenadno poslabšanje ali izgubo vida, prenehajte jemati zdravilo Tadalafil Lilly in se takoj obrnite na svojega zdravnika.
English: As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil Lilly 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 Tadalafil Lilly in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4.3).
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 Tadalafil Lilly, 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 Tadalafil Lilly.
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
English: Following sexual stimulation Tadalafil Lilly works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis.
Slovenian: Po spolni stimulaciji zdravilo Tadalafil Lilly deluje tako, da pomaga pri sproščanju krvnih žil v vašem penisu in s tem omogoča dotok krvi v penis.
English: What Tadalafil Lilly is and what it is used for What you need to know before you take Tadalafil Lilly How to take Tadalafil Lilly
Slovenian: Kaj je zdravilo Tadalafil Lilly in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tadalafil Lilly Kako jemati zdravilo Tadalafil Lilly
English: Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Slovenian: Mehanizem delovanja Tadalafil je selektivni reverzibilni zaviralec ciklični gvanozin-monofosfat (cGMP)-specifične fosfodiesteraze tipa 5 (PDE5).
English: Tadalafil Lilly has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.
Slovenian: Za zdravilo Tadalafil Lilly je dokazano, da te simptome sečil izboljša že v 1-2 tednih po začetku zdravljenja.
English: Tadalafil Lilly, 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).
Slovenian: Zdravilo Tadalafil Lilly je potrebno previdno uporabljati pri bolnikih z anatomsko deformacijo penisa (kot so ukrivljenost, kavernozna fibroza ali Peyroniejeva bolezen), ali pri bolnikih s stanji, ki bi lahko povečala dovzetnost za priapizem (kot so srpastocelična anemija, multipli mielom ali levkemija).
English: Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking Tadalafil Lilly (86 %, 83 %, and 72 % for mild, moderate, and severe, respectively, as compared to 45 %, 42 %, and 19 % with placebo).
Slovenian: Nadalje so bolniki z erektilnimi disfunkcijami v vseh kategorijah resnosti poročali o izboljšanih erekcijah v času jemanja zdravila Tadalafil Lilly (86 %, 83 % oziroma 72 % za blago, zmerno oziroma hudo v primerjavi s 45 %, 42 % oziroma 19 % pri placebu).
English: PDE5 inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effects of this medicine.
Slovenian: Zaviralci PDE5, kot je Tadalafil Lilly, dokazano povečujejo hipotenzivne učinke tega zdravila.
English: It is not known if Tadalafil Lilly is effective in patients who have had: - pelvic surgery.
Slovenian: Ni znano, če je zdravilo Tadalafil Lilly učinkovito pri bolnikih, ki so imeli: - operacijo v medenici.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. marec 2017
English: However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is coadministered with 5-ARIs.
Slovenian: Ker pa uradna študija medsebojnega delovanja zdravil, ki bi ocenila učinke tadalafila in zaviralcev 5-alfa reduktaze (5-ARI), ni bila opravljena, je potrebna previdnost ob sočasni uporabi tadalafila s 5-ARI.
English: Tadalafil Lilly does not treat prostate cancer.
Slovenian: Zdravilo Tadalafil Lilly ne zdravi raka prostate.
English: The majority of headaches reported with Tadalafil Lilly once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.
Slovenian: Večino glavobolov, o katerih poročajo bolniki, ki jemljejo zdravilo Tadalafil Lilly v odmerku enkrat na dan, bolniki občutijo v prvih 10 do 30 dneh po začetku zdravljenja.
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Slovenian: Pri psih, ki so tadalafil prejemali dnevno 6 do 12 mesecev v odmerkih 25 mg/kg/dan (kar pomeni vsaj 3-krat večjo izpostavitev [razpon 3,718,6], kot je bila opažena pri ljudeh pri enkratnem odmerku 20 mg) in več, je prišlo do regresije epitela semenskih cevk, kar je pri nekaterih psih povzročilo zmanjšanje spermatogeneze.
English: Tadalafil Lilly will not help you if you do not have erectile dysfunction.
Slovenian: Zdravilo Tadalafil Lilly vam ne bo pomagalo, če nimate erektilne disfunkcije.
English: The improvement in the total international prostate symptom score with Tadalafil Lilly 5 mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2, -3.6, -3.8 and -4.2 with placebo.
Slovenian: Izboljšanje skupnega rezultata na mednarodni lestvici prostatičnih simptomov z zdravilom Tadalafil Lilly 5 mg v štirih študijah je znašalo -4,8, -5,6, -6,1 in -6,3 v primerjavi z -2,2, -3,6, -3,8 in -4,2 s placebom.
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
English: Tadalafil Lilly has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Slovenian: Za zdravilo Tadalafil Lilly so dokazali, da bistveno izboljša zmožnost doseganja trdega, pokončnega penisa, ki je potreben za spolno aktivnost.
English: Tadalafil Lilly, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Slovenian: Zdravila Tadalafil Lilly ne smemo uporabljati pri moških s srčnim obolenjem, katerim je spolna aktivnost odsvetovana.
English: In patients who anticipate a frequent use of Tadalafil Lilly (i.e., at least twice weekly) a once daily regimen with the lowest doses of Tadalafil Lilly might be considered suitable, based on patient choice and the physician's judgement.
Slovenian: Pri bolnikih, ki pričakujejo pogosto uporabo zdravila Tadalafil Lilly (npr. vsaj dvakrat tedensko) je morda primerno odmerjanje najnižjih odmerkov zdravila Tadalafil Lilly enkrat na dan, glede na izbiro bolnika in presojo zdravnika.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
English: (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Slovenian: (LS) 6MWD v 48. tednu je v skupini s placebom znašala -51,0 metra (m), v primerjavi z -64,7 m v skupini s tadalafilom 0,3 mg/kg (p = 0,307) in -59,1 m v skupini s tadalafilom 0,6 mg/kg (p = 0,538).
English: Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Lilly and contact your doctor immediately.
Slovenian: Čeprav ni znano, ali je ta dogodek neposredno povezan s tadalafilom, morate v primeru poslabšanja ali nenadne izgube sluha prenehati z jemanjem zdravila Tadalafil Lilly in se takoj obrniti na zdravnika.
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Slovenian: Preučevali so poglavitne razrede antihipertenzivnih zdravil, vključno z zaviralci kalcijevih kanalčkov (amlodipin), zaviralci angiotenzin konvertaze (enalapril), zaviralci adrenergičnih receptorjev beta (metoprolol), tiazidnimi diuretiki (bendrofluazid) in zaviralci receptorjev angiotenzina II (različni tipi in odmerki, posamezno ali v kombinaciji s tiazidi, zaviralci kalcijevih kanalčkov, zaviralci adrenergičnih receptorjev beta in/ali zaviralci adrenergičnih receptorjev alfa).
English: (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Slovenian: (očistek kreatinina 31 do 50 ml/min) okvaro ledvic ter pri osebah s končno odpovedjo ledvic na dializi približno podvojila.
English: The rate and extent of absorption of tadalafil are not influenced by food, thus Tadalafil Lilly may be taken with or without food.
Slovenian: Ker hrana ne vpliva na stopnjo in obseg absorpcije tadalafila, se lahko zdravilo Tadalafil Lilly vzame s hrano ali brez nje.
English: If you take more Tadalafil Lilly than you should Contact your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila Tadalafil Lilly, kot bi smeli Posvetujte se s svojim zdravnikom.
English: The study included a 48-week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily.
Slovenian: 48-tedensko dvojno slepo obdobje, v katerem so bili bolniki randomizirani v skupine, ki so vsakodnevno prejemale tadalafil 0,3 mg/kg, tadalafil 0,6 mg/kg ali placebo.
English: Tadalafil Lilly has been shown to increase the effects of these medicines.
Slovenian: Za zdravilo Tadalafil Lilly je bilo namreč ugotovljeno, da učinke teh zdravil poveča.
English: It is not known if Tadalafil Lilly is effective in patients who have undergone pelvic surgery or radical nonnerve-sparing prostatectomy.
Slovenian: Ni znano, ali je zdravilo Tadalafil Lilly učinkovito pri bolnikih po operacijah v medenici ali po radikalni prostatektomiji brez ohranjanja živcev.
English: • You should not take Tadalafil Lilly more than once a day.
Slovenian: • Zdravila Tadalafil Lilly ne smete vzeti več kot enkrat na dan.
English: Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of Tadalafil Lilly is not recommended in patients with severe renal impairment.
Slovenian: Zaradi povečane izpostavljenosti (AUC) tadalafilu, pomanjkanja kliničnih izkušenj in ne vplivanja dialize na klirens, odmerjanje zdravila Tadalafil Lilly enkrat na dan ni priporočljivo za bolnike s hudo okvaro ledvic.
English: 5 How to store Tadalafil Lilly Contents of the pack and other information
Slovenian: Shranjevanje zdravila Tadalafil Lilly Vsebina pakiranja in dodatne informacije
English: 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily.
Slovenian: mesečna študija) in 20 mg (ena 6-mesečna in ena 9-mesečna študija), ki so ga dajali dnevno, na spermatogenezo.
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebocontrolled clinical trials (comprising a total of 8022 patients on Tadalafil Lilly and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Slovenian: Spodnja tabela navaja neželene učinke, ki so jih opažali v spontanih poročanjih in v kliničnih preskušanjih, nadzorovanih s placebom (v katera je bilo skupno vključenih 8022 bolnikov, ki so prejemali zdravilo Tadalafil Lilly, in 4422 bolnikov, ki so prejemali placebo) za zdravljenje erektilne disfunkcije po potrebi in enkrat na dan ter za zdravljenje benigne hiperplazije prostate enkrat na dan.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with Tadalafil Lilly 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Slovenian: Izboljšanje na področju erektilne funkcije po mednarodnem indeksu erektilne funkcije in skupni rezultat na mednarodni lestvici prostatičnih simptomov sta v tej študiji znašala 6,5 in -6,1 z zdravilom Tadalafil Lilly 5 mg v primerjavi z 1,8 in3,8 s placebom.
English: The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly.
Slovenian: O neželenem učinku omotici so pogosteje poročali pri moških nad 75. letom starosti, ki so jemali zdravilo Tadalafil Lilly.
English: Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section 4.3).
Slovenian: Pred uvedbo zdravljenja benigne hiperplazije prostate s tadalafilom je treba bolnike pregledati in izključiti prisotnost karcinoma prostate ter natančno oceniti njihove srčnožilne bolezni (glejte poglavje