FrancophonIA/ELRC3.0 huggingface dataset:
English: In support of the application, the applicant/MAH performed three single dose studies under fasting conditions with the 18, 36 and 54 mg tablets and one single dose study under fed conditions with the 54 mg tablet.
Croatian: U prilog zahtjevu, podnositelj zahtjeva/MAH proveo je tri ispitivanja jednostruke doze u uvjetima natašte s tabletama od 18, 36 i 54 mg i jedno ispitivanje jednostruke doze u uvjetima uz hranu s tabletom od 54 mg.
English: The results showed that by identifying true biphasic profiles for the early absorption phase, bioequivalence for both the AUC and Cmax during the initial phase between both investigational products is proven.
Croatian: Rezultati su pokazali da je utvrđivanjem stvarnih bifazičnih profila za ranu fazu apsorpcije dokazana bioekvivalencija oba lijeka u ispitivanju i za PIK i za Cmax tijekom početne faze.
English: In a post-hoc analysis, the applicant/MAH further provided results for partial metrics (AUC and Cmax) for the immediate release phase and the extended release phase within 0-2 hours and 2-24 hours.
Croatian: U post-hoc analizi podnositelj zahtjeva/MAH nadalje je dao rezultate parcijalnih mjerenja (PIK i Cmax) za fazu s neposrednim oslobađanjem i fazu s produljenim oslobađanjem unutar 0-2 sata i 2-24 sata.
English: The applicant/MAH requests extrapolation of the results from the fed study with 54 mg tablet to the lower strengths.
Croatian: Podnositelj zahtjeva/MAH zahtijeva ekstrapolaciju rezultata ispitivanja uz hranu s tabletom od 54 mg na manje jačine.
English: The study evaluated the subjects which showed the characteristic biphasic profile of methylphenidate osmotic release formulation during the initial phase for both test and reference (n=8), and excluded subjects showing a continuous profile for at least one of the treatments.
Croatian: U ispitivanju su procijenjeni ispitanici koji su pokazali karakteristični bifazični profil formulacije metilfenidata s osmotskim oslobađanjem tijekom početne faze za ispitivani i referentni lijek (n=8), a isključeni su ispitanici koji su pokazali kontinuirani profil za jedno od liječenja.
English: These considerations are in principle valid for studies in fed state and in fasting state.
Croatian: Ta su promatranja u načelu važeća za ispitivanja u stanju sitosti i natašte.
English: Methylphenidate Sandoz which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Croatian: Methylphenidate Sandoz koji sadrži djelatnu tvar metilfenidat hidroklorid je filmom obložena tableta s osmotski kontroliranim produljenim oslobađanjem s jezgrom od dva sloja.
English: • all strengths shows comparable dissolution profiles in various media in the pH range 1 to 6.8,
Croatian: • sve jačine pokazuju profile otapanja u različitim medijima u rasponu pH od 1 do 6,8 u FeSSIF-u i FeSSGF-u koji se mogu uspoređivati
English: Bioequivalence has been demonstrated for the prolonged release phase (2-24h) for AUC and Cmax under fed and fasting condition.
Croatian: Dokazana je bioekvivalencija za fazu produljenog oslobađanja (2-24 h) za PIK i Cmax u uvjetima uz hranu i natašte.
English: The results showed that bioequivalence was demonstrated for the studies under fasted conditions between Methylphenidate Sandoz (18mg, 36mg, 54mg) and the reference product for the immediate and prolonged release phase.
Croatian: Rezultati su pokazali da je u ispitivanjima u uvjetima natašte dokazana bioekvivalencija lijeka Methylphenidate Sandoz (18 mg, 36 mg, 54 mg) i referentnog lijeka za fazu neposrednog i produljenog oslobađanja.
English: The studies under fed and fasting conditions demonstrated bioequivalence between test and reference product using the entire dose interval (AUC(0-24h) and Cmax(0-24h)).
Croatian: Ispitivanja u uvjetima uz hranu i natašte pokazala su bioekvivalenciju između ispitivanog i referentnog lijeka koristeći cijeli interval doze (PIK(0-24h) i Cmax(0-24h)).
English: Consequently, the dissolved drug from the immediaterelease portion of the dosage form only reaches the intestine with delay.
Croatian: Zato otopljeni lijek iz dijela za neposredno oslobađanje dospijeva u tanko crijevo uz odgodu.
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Sandoz 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Croatian: Zahtjev za davanje odobrenja za stavljanje gotovog lijeka u promet u postupku međusobnog priznavanja koji se može upotrijebiti više puta za lijek Methylphenidate Sandoz u obliku tableta od 18 mg, 36 mg i 54 mg generički je zahtjev u skladu sa Člankom 10.1 Direktive 2001/83/EZ.
English: The first pharmacokinetic studies were performed by the applicant/MAH in 2009-2010 and submitted in the first DCP starting in January 2011.
Croatian: Marketing Authorisation Holder) u 2009.-2010. i s početkom u siječnju 2011. podnio je prvi decentralizirani postupak (DCP).
English: • The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Sandoz 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
Croatian: • Povjerenstvo je pregledalo sve podatke koje je predao podnositelj zahtjeva kako bi potkrijepio bioekvivalenciju između tableta lijeka Methylphenidate Sandoz s produljenim oslobađanjem od 18 mg, 36 mg, 54 mg i referentnog lijeka.
English: The fed study failed to fulfil the standard acceptance criteria for bioequivalence for the immediate-release phase (AUC (0-2h) and Cmax(0-2h)).
Croatian: Ispitivanja uz hranjenje nisu zadovoljila standardne zahtjeve za prihvaćanje po pitanju bioekvivalencije u fazi neposrednog oslobađanja (PIK(0-2h) i Cmax(0-2h)).
English: The product is a biphasic modified release formulation, with an immediate release (IR) phase and a prolonged-release (PR) phase.
Croatian: Lijek je u obliku bifazne formulacije s prilagođenim oslobađanjem s fazom neposrednog oslobađanja (NO) i fazom produljenog oslobađanja (PO).
English: The additional in vitro dissolution profiles of test and reference product without the immediate release coating demonstrate that a lag time is seen for the prolonged release part and that the active substance in the immediate layer is released fast and independent from the prolonged release part. All in vivo and in vitro results indicate that the prolonged release phase (osmotic controlled) is unaffected by food intake.
Croatian: Dodatni profili otapanja in vitro ispitivanog i referentnog lijeka bez sloja za neposredno oslobađanje pokazuju da postoji vrijeme odgode kod dijela za produljeno oslobađanje i da se djelatna tvar iz sloja za neposredno oslobađanje oslobađa brzo i neovisno od dijela za produljeno oslobađanje.
English: In consequence, the sustained process of absorption of the immediate release fraction appears to overlap with the absorption of the prolonged release fraction of the biphasic formulation.
Croatian: Stoga se čini kako se odgođeni postupak apsorpcije frakcije za neposredno oslobađanje preklapa s apsorpcijom frakcije za produljeno oslobađanje bifazične formulacije.
English: The current repeat use procedure started in April 2012, two months after the EMA Question & Answer Position Paper (EMA/618604/2008 Rev. 4) concerning biphasic formulations was published.
Croatian: Važeći postupak za ponovljenu uporabu započeo je u travnju 2012., dva mjeseca nakon objave Članka s pitanjima i odgovorima zasnovanog na stavovima Europske agencije za lijekove (EMA, eng.
English: The studies demonstrated bioequivalence between test and reference product according to the guideline requirements for a modified release dosage form (Guideline on the investigation of bioequivalence, 2010 CPMP/EWP/QWP/1401/98 Rev. 1 and Note for Guidance on Modified Release Oral and Transdermal Dosage Forms, 1999 EMA/CPMP/EWP/280/96 Corr*) in force at time of study conduct (2009 - 2010).
Croatian: 1 i Napomena za smjernice o prilagođenom oslobađanju oralnih i transdermalnih oblika za doziranje (Note for Guidance on Modified Release Oral and Transdermal Dosage Forms), 1999. EMA/CPMP/EWP/280/96 Corr*) koje su bile na snazi tijekom provođenja ispitivanja (2009.-2010.).
English: • For the first phase, the assessment of equivalence should be based on the truncated AUC from t=0 until the cut-off time describing the immediate release dose fraction, and on Cmax during the first phase.
Croatian: • Za prvu fazu, procjena ekvivalencije mora se temeljiti na skraćenom PIK-u od t=0 do vremenske točke granične vrijednosti opisujući frakciju neposrednog oslobađanja i na temelju
English: The dissolution is rapid for the outer coating and similar between the test and reference product in various media in the pH range 1 to 6.8 as well as in FeSSIF (Fed state simulated intestinal fluid) and FeSSGF (Fed state simulated gastric fluid).
Croatian: Otapanje vanjskog sloja brzo je i slično ispitivanom lijeku u različitim sredstvima u rasponu pH vrijednosti od 1 do 6,8 kao i u tekućini koja oponaša crijevni sadržaj nakon obroka (FeSSIF, eng.
English: Furthermore, the extrapolation of the fed study conducted with the highest strength 54mg to the lower strengths was not considered acceptable.
Croatian: Nadalje, nije prihvatljiva ekstrapolacija ispitivanja uz hranu s najvećom jačinom lijeka od 54 mg na manje jačine lijeka.
English: A clear cut-off between the immediate and extended release fraction as required by the Q&A position paper is not feasible under these conditions.
Croatian: U tim uvjetima nije moguće napraviti jasnu podjelu između frakcija za neposredno i produljeno oslobađanje kako se traži u članku s pitanjima i odgovorima zasnovanom na stavovima.
English: Methylphenidate Sandoz (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Croatian: Attention Deficit/Hyperactivity Disorder) kod djece u dobi od 6 do 18 godina jednom dnevno ujutro i može se uzimati uz obrok ili bez obroka.
English: Concentration maximal (0-2h) (Cmax(0-2h)), Area Under the Curve(0-2h) (AUC(0-2h)), Cmax(2-24h), AUC (2-24h)) had not been shown between the applied and the reference product.
Croatian: Tijekom postupka za međusobno priznavanje (MRP, eng. mutual recognition procedure) za ponovljenu uporabu Njemačka i Nizozemska navele su da nisu prikazani podaci parcijalnih mjerenja bioekvivalencije u uvjetima uz hranu (tj. maksimalna koncentracija (0-2h) (Cmax(0-2h)), površina ispod krivulje(0-2h) (PIK(0-2h)), Cmax(2-24h), PIK (2-24h)) za primijenjeni i referentni lijek.
English: The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Croatian: Odustajanje od ispitivanja u uvjetima uz hranu za jačine od 18 mg i 36 mg Bioekvivalencija u uvjetima uz hranu ispitivala se samo za jačinu od 54 mg.
English: Whereas
Croatian: S obzirom na sljedeće činjenice
English: A referral was thus triggered at the CMD(h).
Croatian: Stoga je predmet upućen Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMD(h), eng.
English: • At the request of the European Medicines Agency
Croatian: • na zahtjev Europske agencije za lijekove
English: Information on the effect of alcohol is in section 3.
Croatian: Informacije o učinku alkohola nalaze se u dijelu 3.
English: It may harm them,
Croatian: Među njih se ubrajaju:
English: Swallow the tablet whole with some water.
Croatian: Tabletu progutajte cijelu s malo vode.
English: CIALIS with drink and alcohol
Croatian: CIALIS s pićem i alkoholom
English: Therefore this combination is not recommended (see section 4.4).
Croatian: Stoga se ova kombinacija ne preporučuje (vidjeti dio 4.4).
English: Do not take CIALIS if you are already taking nitrates.
Croatian: Nemojte uzimati CIALIS ako već uzimate nitrate.
English: Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet.
Croatian: Uzmite dozu čim se sjetite, ali nemojte uzeti dvostruku dozu da biste nadoknadili zaboravljenu dozu.
English: Talk to your doctor for further information.
Croatian: Obratite se svome liječniku za dodatne informacije.
English: Date of last renewal: 12 November 2012
Croatian: Datum posljednje obnove odobrenja: 12. studenog 2012.
English: • Risk Management Plan (RMP)
Croatian: PRIMJENU LIJEKA  Plan upravljanja rizikom (RMP)
English: Most of these men had known heart problems before taking this medicine.
Croatian: Većina tih muškaraca imala je tegobe sa srcem i prije uzimanja ovog lijeka.
English: See also section 5.1.
Croatian: Vidjeti i dio 5.1.
English: In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study.
Croatian: Nadalje, nije bilo dokaza djelotvornosti ni u jednoj od sekundarnih analiza provedenih u ovom ispitivanju.
English: This effect lasts at least twelve hours and may be symptomatic, including syncope.
Croatian: Ovaj učinak traje najmanje 12 sati, a može izazvati simptome, uključujući sinkopu.
English: - have serious heart disease or recently had a heart attack within the last 90 days.
Croatian: - ako imate ozbiljnu srčanu bolest ili ste pretrpjeli srčani udar u posljednjih 90 dana.
English: Across all clinical studies, reports of changes in colour vision were rare (< 0.1 %).
Croatian: U svim su kliničkim ispitivanjima izvješća o promjenama u raspoznavanju boja bila rijetka (< 0,1%).
English: • Always take CIALIS exactly as your doctor has told you.
Croatian: • Uvijek uzmite CIALIS točno onako kako Vam je rekao liječnik.
English: Take CIALIS with water every day at approximately the same time, either with or without food.
Croatian: Uzmite CIALIS s vodom svaki dan otprilike u isto doba, s hranom ili bez nje.
English: In cases of overdose, standard supportive measures should be adopted as required.
Croatian: U slučaju predoziranja treba po potrebi primijeniti standardne potporne mjere.
English: Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Croatian: Rijetko je prijavljeno djelomično, privremeno ili trajno smanjenje ili gubitak vida na jednom ili oba oka.
English: An updated RMP shall be submitted every three years.
Croatian: Ažurirani RMP podnosi se svake tri godine.
English: Adverse events were similar to those seen at lower doses.
Croatian: Nuspojave su bile slične onima opaženima pri manjim dozama.
English: The tablets can be taken with or without food.
Croatian: Tablete možete uzimati s hranom ili bez nje.
English: What CIALIS is and what it is used for
Croatian: Što je CIALIS i za što se koristi
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.
Croatian: Međutim, nije moguće sa sigurnošću odrediti jesu li ti događaji izravno povezani s navedenim faktorima rizika, lijekom CIALIS, seksualnom aktivnošću ili kombinacijom ovih ili drugih faktora.
English: Consequently the incidence of the adverse reactions listed in section 4.8 might be increased.
Croatian: Kao posljedica toga mogla bi se povećati incidencija nuspojava navedenih u dijelu 4.8.
English: Children and adolescents CIALIS is not intended for use by children and adolescents under the age of 18.
Croatian: CIALIS nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins.
Croatian: Pri terapijskim koncentracijama se 94% tadalafila u plazmi vezuje za proteine.
English: The patients should be informed not to take CIALIS in such combinations.
Croatian: Bolesnike treba upozoriti da ne smiju uzimati CIALIS u takvim kombinacijama.
English: Treatments should be initiated at minimal dosage and progressively adjusted.
Croatian: Liječenje treba započeti najmanjom dozom i postupno je povećavati.
English: This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”).
Croatian: To je skupina lijekova ("nitrati") koja se koristi za liječenje angine pektoris ("bol u prsnom košu").
English: The result of this is improved erectile function.
Croatian: Rezultat toga je poboljšana erektilna funkcija.
English: The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.
Croatian: Prosječan volumen distribucije iznosi približno 63 l, što ukazuje na to da se tadalafil raspodjeljuje u tkiva.
English: This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
Croatian: To je stanje kada muškarac ne može postići ili održati dostatno ukrućen penis za uspješnu seksualnu aktivnost.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i reproduktivne toksičnosti.
English: Start with the pill from the blister pack that corresponds with the day you start taking CIALIS.
Croatian: Počnite s tabletom iz blistera koja odgovara danu kad počinjete uzimati CIALIS.
English: Ethinylestradiol and terbutaline
Croatian: Etinilestradiol i terbutalin
English: Most patients reported erectile dysfunction of at least 1 year in duration.
Croatian: Većina je bolesnika prijavila erektilnu disfunkciju u trajanju od najmanje godine dana.
English: CIALIS may still be effective up to 36 hours after taking the tablet.
Croatian: CIALIS može djelovati do 36 sati nakon uzimanja tablete.
English: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Croatian: Bolesnike koji imaju erekcije u trajanju od 4 sata ili dulje treba uputiti da odmah potraže liječničku pomoć.
English: The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.
Croatian: Vrijeme doziranja (ujutro naspram navečer) nije imalo klinički značajnih učinaka na brzinu i opseg apsorpcije.
English: - other medicines to treat high blood pressure.
Croatian: - druge lijekove za liječenje visokog krvnog tlaka.
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Croatian: Nije bilo dokaza povoljnog kliničkog učinka ove kombinacije u ispitivanoj populaciji.
English: A reduction in sperm was seen in some men.
Croatian: Smanjena količina sperme primijećena je i u nekih muškaraca.
English: These effects are normally mild to moderate in nature.
Croatian: Ovi učinci su obično blage do umjerene naravi.
English: Less than 0.0005 % of the administered dose appeared in the semen of healthy subjects.
Croatian: Manje od 0,0005% primijenjene doze ustanovljeno je u spermi zdravih ispitanika.
English: <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Croatian: U ispitivanjima interakcija provedenima na malom broju zdravih dobrovoljaca ovi učinci nisu zabilježeni kod primjene alfuzosina ili tamsulozina.
English: Alcohol was administered in a manner to maximise the rate of alcohol absorption (overnight fast with no food until 2 hours after alcohol).
Croatian: Alkohol je primijenjen na način da se maksimizira brzina apsorpcije alkohola (post tijekom noći bez unosa hrane 2 sata nakon primjene alkohola).
English: - sudden loss of vision (frequency rare).
Croatian: - iznenadan gubitak vida (rijetka učestalost).
English: Other medicines and CIALIS Tell your doctor if you are taking, have recently taken or might take any other medicines
Croatian: Drugi lijekovi i CIALIS Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet lijeka:
English: It may be taken at least 30 minutes prior to sexual activity.
Croatian: Lijek se može uzeti barem 30 minuta prije seksualne aktivnosti.
English: What Cialis looks like and contents of the pack
Croatian: Kako CIALIS izgleda i sadržaj pakiranja
English: The combination of tadalafil and doxazosin is not recommended.
Croatian: Ne preporučuje se istodobna primjena tadalafila i doksazosina.
English: Other side effects have been reported:
Croatian: Prijavljene su i druge nuspojave:
English: You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Croatian: Vi i Vaša partnerica morate se upustiti u predigru, baš kao što biste učinili da ne uzimate lijek za erektilnu disfunkciju.
English: CIALIS does not treat prostate cancer.
Croatian: CIALIS ne liječi rak prostate.
English: Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
Croatian: Doziranje lijeka CIALIS jednom na dan može biti korisno u muškaraca koji očekuju da će spolni odnos imati dva ili više puta na tjedan.
English: The improvements in total international prostate symptom score occurred as early as 1 week.
Croatian: Poboljšanja ukupnog rezultata na Međunarodnoj ljestvici simptoma prostatizma nastupila su već nakon 1 tjedna.
English: Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
Croatian: Imajte na umu da seksualna aktivnost nosi mogući rizik u bolesnika sa srčanom bolešću jer dodatno opterećuje srce.
English: Decreased or sudden hearing loss
Croatian: Slabljenje ili iznenadan gubitak sluha
English: Myalgia, Pain in extremity
Croatian: mialgija, bol u ekstremitetima
English: Most of these ECG abnormalities were not associated with adverse reactions.
Croatian: Većina tih nepravilnosti EKG-a nije bila povezana s nuspojavama.
English: A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen.
Croatian: Provedeno je jedno ispitivanje u pedijatrijskih bolesnika s Duchenneovom mišićnom distrofijom (DMD) u kojem nisu primijećeni dokazi djelotvornosti.
English: This difference in exposure does not warrant a dose adjustment.
Croatian: Ova razlika u izloženosti ne zahtijeva prilagođavanje doze.
English: As a precautionary measure, it is preferable to avoid the use of CIALIS during pregnancy.
Croatian: Kao mjeru opreza poželjno je izbjegavati primjenu lijeka CIALIS u trudnoći.
English: What you need to know before you take CIALIS
Croatian: Što morate znati prije nego počnete uzimati CIALIS
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).
Croatian: Dva klinička ispitivanja koja su uslijedila nakon toga uputila su na činjenicu da navedeni učinak nije vjerojatan u ljudi, iako je u nekih muškaraca primijećeno smanjenje koncentracije sperme (vidjeti dijelove 5.1 i 5.3).
English: Elderly men
Croatian: Stariji muškarci
English: - have low blood pressure or uncontrolled high blood pressure.
Croatian: - ako imate nizak krvni tlak ili nekontroliran visok krvni tlak.
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).
Croatian: Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na trudnoću, razvoj embrija i fetusa, okot i postnatalni razvoj (vidjeti dio 5.3).