FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.
Croatian: Ako bolujete od benigne hiperplazije prostate i erektilne disfunkcije, doza je također jedna tableta od 5 mg jedanput na dan.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects.
Croatian: U bolesnika sa šećernom bolešću je izloženost tadalafilu (AUC) bila otprilike 19% manja nego u zdravih ispitanika.
English: In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined.
Croatian: U kliničkim farmakološkim ispitivanjima proučavao se potencijal tadalafila da pojača hipotenzivne učinke antihipertenziva.
English: There are limited data from the use of tadalafil in pregnant women.
Croatian: Podaci o primjeni tadalafila u trudnica su malobrojni.
English: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Croatian: Papendorpseweg 83, 3528 BJ Utrecht Nizozemska
English: Grapefruit juice may affect how well CIALIS will work and should be taken with caution.
Croatian: Sok od grejpa može utjecati na djelotvornost lijeka CIALIS i zato ga se mora konzumirati uz oprez.
English: Nederland Eli Lilly Nederland B.V.
Croatian: Eli Lilly Nederland B.V.
English: In clinical trials with tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Croatian: U kliničkim ispitivanjima u kojima se tadalafil u dozi od 5 mg primjenjivao jedanput na dan za liječenje benigne hiperplazije prostate, omaglica i proljev prijavljivani su češće u bolesnika u dobi iznad 75 godina.
English: Transporters
Croatian: Prijenosnici
English: Use with CYP3A4 inhibitors
Croatian: Primjena s inhibitorima CYP3A4
English: Riociguat
Croatian: Riocigvat
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: Nositelj odobrenja: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %.
Croatian: Ketokonazol (400 mg na dan) je učetverostručio izloženost (AUC) tadalafilu (20 mg) i povećao Cmax za 22%.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU
English: CIALIS is not indicated for use by women.
Croatian: CIALIS nije indiciran za primjenu u žena.
English: These include: migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Croatian: - migrena, oticanje lica, teške alergijske reakcije koje izazivaju oticanje lica ili grla, ozbiljni kožni osipi, neki poremećaji koji utječu na dotok krvi u oči, nepravilni otkucaji srca, angina i iznenadna srčana smrt.
English: CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Croatian: CIALIS tablete od 10 mg i 20 mg namijenjene su za uporabu prije planirane seksualne aktivnosti i ne preporučuju se za trajnu svakodnevnu primjenu.
English: OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija,
English: For the treatment of erectile dysfunction using on-demand CIALIS the recommended dose of CIALIS is 10 mg taken prior to anticipated sexual activity and with or without food.
Croatian: Kada se uzima po potrebi za liječenje erektilne disfunkcije, preporučena doza lijeka CIALIS je 10 mg, a uzima se prije očekivane seksualne aktivnosti, s hranom ili bez nje.
English: Some additional rare side effects have been reported in men taking CIALIS that were not seen in clinical trials.
Croatian: U muškaraca koji su uzimali CIALIS prijavljene su neke dodatne rijetke nuspojave koje nisu primijećene u kliničkim ispitivanjima.
English: There is no relevant use of CIALIS in the paediatric population with regard to the treatment of erectile dysfunction.
Croatian: U pedijatrijskoj populaciji nema relevantne primjene lijeka CIALIS povezane s liječenjem erektilne disfunkcije.
English: Cytochrome P450 metabolised medicinal products Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Croatian: Ne očekuje se da bi tadalafil mogao izazvati klinički značajnu inhibiciju ili indukciju klirensa lijekova koje metaboliziraju izoforme CYP450.
English: Once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Croatian: Primjena tadalafila jedanput na dan ne preporučuje se u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dijelove 4.4 i 5.2).
English: - urinary symptoms associated with a common condition called benign prostatic hyperplasia.
Croatian: - simptome u mokraćnom sustavu povezane s čestom bolešću koja se naziva benignom hiperplazijom prostate.
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.
Croatian: Međutim, budući da nije provedeno formalno ispitivanje interakcija kojim bi se procijenio učinak tadalafila na inhibitore 5-alfa reduktaze, tadalafil se s tom skupinom lijekova mora primjenjivati uz oprez.
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Croatian: U kliničkim farmakološkim ispitivanjima s primjenom jedne doze tadalafila (5 do 20 mg) izloženost tadalafilu (AUC) se otprilike udvostručila u ispitanika s blagim (klirens kreatinina 51 do 80 ml/min) ili umjerenim (klirens kreatinina 31 do 50 ml/min) oštećenjem bubrežne funkcije i u ispitanika u terminalnoj fazi bubrežne bolesti na dijalizi.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Croatian: Tadalafil djeluje > 10 000 puta jače na PDE5 nego na PDE3, enzim koji se nalazi u srcu i krvnim žilama.
English: Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS.
Croatian: Ovisno o Vašem odgovoru na CIALIS, liječnik može prilagoditi dozu na 2,5 mg.
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Croatian: U kliničkim se ispitivanjima pokazalo da riocigvat pojačava hipotenzivne učinke inhibitora PDE5.
English: The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - patients with myocardial infarction within the last 90 days, - patients with unstable angina or angina occurring during sexual intercourse, - patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, - patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, - patients with a stroke within the last 6 months.
Croatian: Sljedeće skupine bolesnika s kardiovaskularnom bolešću nisu bile uključene u klinička ispitivanja pa je primjena tadalafila u tim skupinama kontraindicirana: - bolesnici koji su u prethodnih 90 dana pretrpjeli infarkt miokarda, - bolesnici s nestabilnom anginom ili anginom koja se javlja tijekom spolnog odnosa, - bolesnici u kojih je u posljednjih 6 mjeseci došlo do zatajivanja srca 2. ili višeg stupnja prema
English: Musculoskeletal, connective tissue and bone disorders Back pain,
Croatian: Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju bol u leđima,
English: Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections 4.
Croatian: Primjena tadalafila jedanput na dan u dozama od 2,5 ili 5 mg, kako za liječenje erektilne disfunkcije tako i za liječenje benigne hiperplazije prostate, ne preporučuje se u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dijelove 4.4 i 5.2).
English: Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Croatian: Ispitivanja in vitro pokazala su da je tadalafil selektivan inhibitor PDE5.
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.
Croatian: Ispitivanje je obuhvaćalo 48-tjedno razdoblje dvostruko slijepog liječenja u kojem su bolesnici randomizirani za svakodnevno primanje tadalafila u dozi od 0,3 mg/kg, tadalafila u dozi od 0,6 mg/kg ili placeba.
English: In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Croatian: U 12-tjednom ispitivanju u kojemu je sudjelovalo 186 bolesnika (142 su primala tadalafil, a 44 placebo) s erektilnom disfunkcijom kao posljedicom ozljede leđne moždine tadalafil je značajno poboljšao erektilnu funkciju pa je srednji udio po ispitaniku uspješnih pokušaja spolnog odnosa u bolesnika liječenih tadalafilom u dozi od 10 ili 20 mg (fleksibilna doza, uzimanje po potrebi) bio 48%, dok je kod primjene placeba ta vrijednost bila 17%.
English: CIALIS should not be used during breast feeding.
Croatian: CIALIS se ne smije primjenjivati tijekom dojenja.
English: Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.
Croatian: Pokazalo se da tadalafil, u usporedbi s placebom, dovodi do statistički značajnog poboljšanja erektilne funkcije i bolesnicima omogućuje uspješan spolni odnos do 36 sati nakon uzimanja doze lijeka te postizanje i održavanje erekcije potrebne za uspješan spolni odnos već 16 minuta nakon uzimanja lijeka.
English: In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67 % on CIALIS 5 mg, 50 % on CIALIS 2.5 mg as compared to 31 and 37 % with placebo.
Croatian: U dvama primarnim ispitivanjima djelotvornosti u općoj populaciji srednji udio uspješnih pokušaja spolnog odnosa po ispitaniku bio je 57% odnosno 67% kod primjene lijeka CIALIS u dozi od 5 mg i 50% kod primjene lijeka CIALIS u dozi od 2,5 mg, u usporedbi s 31% i 37% kod primjene placeba.
English: 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.
Croatian: Istodobna primjena doksazosina (4 mg 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.
English: Τηλ: +30 210 629 4600
Croatian: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Τηλ: +30 210 629 4600
English: Diarrhoea has been reported more frequently in men over 65 years of age taking CIALIS.
Croatian: Proljev je češće prijavljivan u muškaraca u dobi iznad 65 godina koji su uzimali CIALIS.
English: For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day.
Croatian: odraslih muškaraca koji se liječe i zbog benigne hiperplazije prostate i zbog erektilne disfunkcije preporučena doza također iznosi 5 mg, a uzima se svakodnevno otprilike u isto doba dana.
English: Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Croatian: Savjetuje se oprez kod propisivanja lijeka CIALIS bolesnicima koji uzimaju jake inhibitore CYP3A4 (ritonavir, sakvinavir, ketokonazol, itrakonazol i eritromicin) jer je kod kombinacije navedenih lijekova primijećena povećana izloženost tadalafilu (AUC) (vidjeti dio 4.5).
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.
Croatian: Zdravim su ispitanicima primijenjene pojedinačne doze do 500 mg, a bolesnicima s erektilnom disfunkcijom višestruke dnevne doze do 100 mg.
English: There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.
Croatian: Nema podataka o primjeni tadalafila u dozama većim od 10 mg u bolesnika s oštećenjem jetre.
English: - ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
Croatian: non-arteritic anterior ischaemic optic neuropathy), stanja koje se opisuje kao “očni udar”.
English: Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Croatian: 700 puta snažnije djeluje na PDE5 nego na PDE6, enzim koji se nalazi u mrežnici i odgovoran je za fototransdukciju.
English: PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine.
Croatian: Pokazalo se da inhibitori PDE5, kao što je CIALIS, pojačavaju učinak toga lijeka na sniženje krvnog tlaka.
English: Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited.
Croatian: Postoje malobrojni podaci o bolesnicima u dobi iznad 65 godina koji su u kliničkim ispitivanjima primali tadalafil ili za liječenje erektilne disfunkcije ili za liječenje benigne hiperplazije prostate.
English: - a serious liver problem.
Croatian: - ozbiljne tegobe s jetrom. - teške tegobe s bubrezima.
English: Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Croatian: Inhibitor proteaze ritonavir (200 mg dvaput na dan), koji inhibira CYP3A4, CYP2C9, CYP2C19 i CYP2D6, udvostručio je izloženost (AUC) tadalafilu (20 mg), ali nije utjecao na Cmax.
English: Men with diabetes Dose adjustments are not required in diabetic patients.
Croatian: Muškarci sa šećernom bolešću Nije potrebno prilagođavati dozu u bolesnika sa šećernom bolešću.
English: CIALIS and other treatments for erectile dysfunction The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Croatian: Nisu ispitane sigurnost i djelotvornost istodobne primjene lijeka CIALIS s drugim inhibitorima PDE5 ili drugim lijekovima za erektilnu disfunkciju.
English: CIALIS tablets are for oral use in men only.
Croatian: CIALIS tablete namijenjene su isključivo za primjenu u muškaraca i uzimaju se kroz usta.
English: For patients with severe renal impairment 10 mg is the maximum recommended dose.
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije maksimalna preporučena doza je 10 mg.
English: Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to CIALIS.
Croatian: Provedena su tri klinička ispitivanja s 1054 bolesnika u kućnom okruženju kako bi se utvrdilo razdoblje odgovora na CIALIS.
English: This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.
Croatian: Taj metabolit ima najmanje 13 000 puta slabije djelovanje na
English: PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
Croatian: PDE5 je enzim koji se nalazi u glatkom mišićju šupljikavog tijela, krvnožilnom i visceralnom glatkom mišićju, mišićima kostura, trombocitima, bubrezima, plućima i malom mozgu.
English: Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors.
Croatian: Većina bolesnika koja je sudjelovala u tim ispitivanjima prethodno je imala pozitivan odgovor na liječenje inhibitorima PDE5 po potrebi.
English: Aluminium/PVC blisters in cartons of 28 film-coated tablets.
Croatian: Aluminijski/PVC blisteri u kutijama s 28 filmom obloženih tableta.
English: In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with CIALIS 5mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.
Croatian: U jednom ispitivanju u kojem je kao aktivni usporedni lijek primijenjen tamsulozin u dozi od 0,4 mg poboljšanje ukupnog rezultata na Međunarodnoj ljestvici simptoma prostatizma iznosilo je -6,3 kod primjene lijeka CIALIS od 5 mg, -5,7 kod primjene tamsulozina i -4,2 kod primjene placeba.
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 CIALIS 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Croatian: Poboljšanja erektilne funkcije prema međunarodnom indeksu erektilne funkcije odnosno poboljšanja ukupnog rezultata na Međunarodnoj ljestvici simptoma prostatizma u tom su ispitivanju iznosila 6,5 odnosno -6,1 nakon primjene lijeka CIALIS u dozi od 5 mg u usporedbi s vrijednostima od 1,8 odnosno -3,8 nakon primjene placeba.
English: Tadalafil has no effect in the absence of sexual stimulation.
Croatian: Tadalafil nema učinka ako izostane seksualna stimulacija.
English: The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena inhibitora PDE5, uključujući tadalafil, sa stimulatorima gvanilat ciklaze kao što je riocigvat, jer može dovesti do simptomatske hipotenzije (vidjeti dio 4.5).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION CIALIS 10 mg film-coated tablets Each tablet contains 10 mg tadalafil.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV CIALIS 10 mg filmom obložene tablete Jedna tableta sadrži 10 mg tadalafila.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V.
English: Myocardial infarction, Unstable angina pectoris2, Ventricular arrhythmia2
Croatian: tahikardija, palpitacije infarkt miokarda, nestabilna angina pektoris2, ventrikularna aritmija2
English: In a subsequent study, 217 patients who were treatmentnaïve to PDE5 inhibitors were randomized to CIALIS 5 mg once a day vs. placebo.
Croatian: U sljedećem je ispitivanju 217 bolesnika koji prethodno nisu bili liječeni inhibitorima PDE5 randomizirano da primaju ili CIALIS u dozi od 5 mg jedanput na dan ili placebo.
English: CIALIS 20 mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.
Croatian: CIALIS 20 mg dostupan je u blister pakiranjima koja sadrže 2, 4, 8, 10 ili 12 tableta.
English: The side effect dizziness has been reported more frequently in men over 75 years of age taking CIALIS.
Croatian: Nuspojava omaglica je češće prijavljivana u muškaraca u dobi iznad 75 godina koji su uzimali CIALIS.
English: The mean per-subject proportion of successful sexual intercourse attempts was 71.9% with CIALIS 5 mg compared to 48.3% with placebo.
Croatian: Prosječan udio uspješnih pokušaja spolnog odnosa po ispitaniku iznosio je 71,9% kod primjene lijeka CIALIS u dozi od 5 mg u usporedbi sa 48,3% nakon primjene placeba.
English: Cytochrome P450 inducers
Croatian: Induktori citokroma P450
English: In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.
Croatian: Za djelotvornost tadalafila u liječenju erektilne disfunkcije potrebna je seksualna stimulacija.
English: Method of administration CIALIS is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Croatian: CIALIS je dostupan u obliku filmom obloženih tableta od 2,5, 5, 10 i 20 mg za peroralnu primjenu.
English: Protein binding is not affected by impaired renal function.
Croatian: Oštećenje bubrežne funkcije ne utječe na vezivanje za proteine.
English: The improvement in the total international prostate symptom score with CIALIS 5mg 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.
Croatian: Međunarodnoj ljestvici simptoma prostatizma (IPSS) nakon primjene lijeka CIALIS u dozi od 5 mg u četiri navedena ispitivanja iznosilo je -4,8, -5,6, -6,1 odnosno -6,3 u usporedbi s rezultatima -2,2, -3,6, -3,8
English: Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking CIALIS (86 %, 83 %, and 72 % for mild, moderate, and severe, respectively, as compared to 45 %, 42 %, and 19 % with placebo).
Croatian: CIALIS prijavili su bolesnici s erektilnom disfunkcijom svih stupnjeva težine (86% onih s blagom, 83% onih s umjerenom i 72% onih s teškom disfunkcijom, u usporedbi s 45%, 42% odnosno 19% kod primjene placeba).
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Croatian: OBLIK I SADRŽAJ 28 filmom obloženih tableta
English: In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.
Croatian: Općenito se preporučuje doza od 10 mg koja se uzima prije očekivane seksualne aktivnosti, s hranom ili bez nje.
English: For the treatment of erectile dysfunction
Croatian: Za liječenje erektilne disfunkcije
English: It is not known if CIALIS is effective in patients who have had: - pelvic surgery.
Croatian: Nije poznato je li CIALIS djelotvoran u bolesnika: - koji su bili podvrgnuti kirurškom zahvatu u zdjelici
English: ELI LILLY ČR, s.r.o.
Croatian: Česká republika ELI LILLY ČR, s.r.o.
English: PHARMACEUTICAL FORM AND CONTENTS 4 film-coated tablets
Croatian: OBLIK I SADRŽAJ 4 filmom obložene tablete
English: Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Croatian: Stoga je kontraindicirana primjena lijeka CIALIS u bolesnika koji uzimaju bilo koji oblik organskih nitrata (vidjeti dio 4.3).
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Croatian: Tadalafil se pretežno metabolizira posredstvom izoenzima (CYP) 3A4 citokroma P450.
English: You should not take CIALIS more than once a day.
Croatian: Ne smijete uzimati CIALIS češće nego jednom na dan.
English: CIALIS 10 mg film-coated tablets Aluminium/PVC blisters in cartons of 4 film-coated tablets.
Croatian: CIALIS 10 mg filmom obložene tablete Aluminijski/PVC blisteri u kutijama sa 4 filmom obloženih tableta.
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.
Croatian: U pasa koji su tijekom 6 do 12 mjeseci svakodnevno primali tadalafil u dozama od 25 mg/kg na dan (što je rezultiralo najmanje trostruko većom izloženošću [raspon 3,7-18,6 puta] od one u ljudi kod primjene jedne doze od 20 mg) i većima,