FrancophonIA/ELRC3.0 huggingface dataset:
English: YPOZANE 1.875 mg tablets for dogs YPOZANE 3.75 mg tablets for dogs YPOZANE 7.5 mg tablets for dogs YPOZANE 15 mg tablets for dogs
Croatian: YPOZANE 1,875 mg tablete za pse YPOZANE 3,75 mg tablete za pse YPOZANE 7,5 mg tablete za pse YPOZANE 15 mg tablete za pse
English: In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Croatian: 4.4 Posebna upozorenja <za svaku od ciljnih vrsta životinja > U pasa u kojih je BPH u svezi sa prostatitisom proizvod se smije davati istodobno kada i antimikrobni lijekovi.
English: SPECIAL STORAGE CONDITIONS Not applicable
Croatian: 11. POSEBNI UVJETI ČUVANJA Nije primjenljivo
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U
English: VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrance
Croatian: VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrancuska
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Peroralna primjena
English: 7.5 mg tablet
Croatian: 7,5 mg tableta
English: 3.75 mg tablet
Croatian: 3,75 mg tableta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija-15 mg
English: Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly.
Croatian: Druge nuspojave uključujući prolazno povraćanje i/ili proljev, poliuriju/polidipsiju, letargiju nisu toliko česte.
English: 1ère avenue - 2065 m - LID 06516 Carros France
Croatian: 1ère avenue - 2065 m - LID 06516 Carros Francuska
English: 3 to 7.5 kg*
Croatian: 3 do 7,5 kg*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 1.875 mg
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija-1,875 mg
English: ATC vet code : QG04C X
Croatian: Farmakoterapijska grupa: Proizvodi za primjenu kod benigne hipertrofije prostate ATCvet kod: QG04C X
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 1.875 mg
Croatian: ILI TRAKAMA BLISTER-1,875 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 3.75 mg
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija-3,75 mg
English: 7.5 to 15 kg
Croatian: 7,5 do 15 kg
English: 30 to 60 kg
Croatian: 30 do 60 kg
English: 15 to 30 kg
Croatian: 15 do 30 kg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 7.5 mg
Croatian: ILI TRAKAMA BLISTER-7,5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 7.5 mg
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija-7,5 mg
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Croatian: 12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH
English: RELEASE
Croatian: NUSPOJAVE
English: REGARD TO SAFE AND EFFECTIVE USE
Croatian: POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE PROIZVODA Nije primjenjivo
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 15 mg
Croatian: ILI TRAKAMA BLISTER-15 mg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 3.75 mg
Croatian: ILI TRAKAMA BLISTER-3,75 mg
English: D. STATEMENT OF THE MRLs Not applicable
Croatian: IZVJEŠĆE O MRL
English: Pregelatinised starch
Croatian: Pregelirani škrob
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate INDICATION(S)
Croatian: Svaka tableta sadrži: 1,875 mg, 3,75 mg, 7,5 mg ili 15 mg osateron acetata
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 15 mg tablete za pse
English: Special precautions for use in animals
Croatian: 4.5 Posebne mjere predostrožnost za primjenu Posebne mjere predostrožnost za primjenu na životinjama
English: E-08950 - Esplugues de Llobregat (Barcelona) Tel: + + 34 93 470 79 40
Croatian: ES-8950 Esplugues de Llobregat (Barcelona).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 1,875 mg tablete za pse
English: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus (P.O.Box 40261, 6302 Larnaca, Cyprus) Tel: +357 24813333
Croatian: LTD 25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA
English: WITHDRAWAL PERIOD(S)
Croatian: INDIKACIJA(E)
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: NAME OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Virbac S.A.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 7,5 mg tablete za pse
English: Luxembourg/Luxemburg VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35
Croatian: B-1300 WAVRE Tel: 32 (0) 10 47 06 35
English: MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET VIRBAC S.A.
English: PHARMACOLOGICAL PROPERTIES
Croatian: FARMAKOLOŠKASVOJSTVA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Virbac S.A.
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Virbac S.A.
English: Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases.
Croatian: Feminizacijski sindrom s hiperplazijom mliječne žlijezde povezan s laktacijom, nije tako čest.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 3,75 mg tablete za pse
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/001
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/004
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/004
English: Treatment duration
Croatian: ROK VALJANOSTI
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/002
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/002
English: Name and address of the manufacturer responsible for batch release Virbac S.A.
Croatian: ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet: Virbac S.A.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/003
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/003
English: YPOZANE tablets to be administered
Croatian: UPUTA O VMP YPOZANE
English: Systemic fungal infections.
Croatian: Sistemske gljivične infekcije.
English: Particular attention was dedicated to the issue of hepatotoxicity.
Croatian: Posebna pozornost posvećena je pitanju hepatotoksičnosti.
English: At the request of the CHMP, an Anti-Infective Scientific Advisory group (SAG) meeting was held on 3 September 2012.
Croatian: Na zahtjev CHMP-a, održan je sastanak Antiinfektivne znanstvene, savjetodavne skupine (SAG) 3. rujna 2012. godine.
English: Moreover, these cases were derived from old publications (from 1980 to 1986) while changes could be expected in the management of patients over more than 25 years.
Croatian: Štoviše, ti slučajevi izvedeni su iz starih publikacija (od 1980. do 1986. godine) dok se promjene mogu očekivati u liječenju bolesnika tijekom više od 25 godina.
English: Several potential mechanisms for this toxicity have been identified but uncertainties still remain.
Croatian: Identificirano je nekoliko potencijalnih mehanizama ove toksičnosti ali nesigurnost je i dalje prisutna.
English: Divergent positions are presented in Appendix III.
Croatian: U prilogu III prikazana su različita stajališta.
English: Ketoconazole does not penetrate well in the Central Nervous System.
Croatian: Ketokonazol ne prodire dobro u središnji živčani sustav.
English: In parallel, on 1 July 2011, France triggered a referral under Article 31of Directive 2001/83/EC, as amended.
Croatian: Usporedno s tim, 1. srpnja 2011. godine Francuska je potaknula procjenu u skladu s člankom 31 Direktive 2001/83/EZ i njenim izmjenama.
English: In Europe, oral formulations of ketoconazole are currently approved in 20 Member States as well as in Iceland and Norway.
Croatian: Europi su peroralne formulacije ketokonazola trenutno odobrene u 20 država članica kao i u na Islandu i u Norveškoj.
English: The marketing authorisation holder extensively discussed the mechanism of hepatotoxicity, widely supported with literature data from 1986 to 2007.
Croatian: Nositelji odobrenja intenzivno su raspravljali o mehanizmu hepatotoksičnosti koji je široko poduprt literaturnim podacima od 1986. do 2007. godine.
English: This was followed by the registration of topical pharmaceutical forms such as cream /ointment/shampoo.
Croatian: Nakon toga uslijedila je registracija farmaceutskih oblika poput kreme/masti/šampona.
English: The therapeutic indications included in the current version of the Company Core Data Sheet (CCDS) of the originator product are as follows:
Croatian: Terapijske indikacije uključene u trenutnu verziju Ključnih podataka tvrtke (CCDS) originatorova lijeka su sljedeće:
English: Dosing recommendations in adults are largely consistent across Member States, at 200 mg per day which can be increased to 400 mg in cases where there is no adequate response.
Croatian: Preporuke o doziranju u odraslih uvelike su dosljedne širom država članica, pri 200 mg po danu što se može povećati na 400 mg u slučajecima kada nema odgovarajućeg odgovora.
English: The level of risk appears to be higher than that observed with other antifungal agents.
Croatian: Čini se da je razina viša od one uočene s drugim antifungicima.
English: Characteristics of acute injuries mainly included cytolysis and may lead to serious outcomes including liver transplantation.
Croatian: Karakteristike akutnih ozljeda uglavnom su uključivale citolizu i mogu uzrokovati ozbiljne ishode uključujući i transplantaciju jetre.
English: Of the 1,505 cases of interest; 880 (58%) were medically validated serious of which 18 life-threatening cases did not present any confounding factors and therefore are supportive of a causal role of ketoconazole.
Croatian: Od tih 1 505 zanimljivih slučajeva njih 880 (58%) bili su medicinski potvrđeni ozbiljni slučajevi od kojih 18 njih opasnih po život nije predstavljalo zbunjujuće faktore i stoga su podržavali uzročnu ulogu ketokonazola.
English: In the literature, incidence of acute injuries is variable and ranged from 1/2000 patients exposed to 12%.
Croatian: U literaturi je incidencija akutnih ozljeda promjenjiva i varira od 1/2 000 izloženih bolesnika do 12%.
English: However, the experts unanimously agreed that these cases were anecdotal and that there was no scientific evidence available to support this claim.
Croatian: Međutim, stručnjaci su se jednoglasno složili da ti slučajevi nisu bili potvrđeni i da nije bio dostupan znanstveni dokaz koji bi podržao ovu tvrdnju.
English: Results from non-clinical toxicity studies indicated the liver and endocrine system as primary target organs.
Croatian: Rezultati iz nekliničkih ispitivanja toksičnosti ukazala su na jetru i endokrini sustav kao primarne ciljne organe.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ketoconazole-containing products for oral use;
Croatian: • Povjerenstvo je razmatralo postupak u skladu s člankom 31 Direktive 2001/83/EZ za lijekove za peroralnu primjenu koji sadrže ketokonazol.
English: The CHMP, having considered the data submitted by the MAH, was of the opinion that the proposed risk minimisation activities were not appropriate to reduce the risks to an acceptable level taking into account the restrictions and warnings already in place.
Croatian: CHMP, uzimajući u obzir podatke predane od strane nositelja odobrenja smatrao je da je predložene aktivnosti minimizacije rizika nisu odgovarajuće za smanjenje rizika na prihvatljivu razinu uzimajući u obzir već postojeća ograničenja i upozorenja.
English: Marketing authorisations have been withdrawn by the MAH in several Member States for commercial reasons and only the 200mg tablet formulation is still available in the EEA.
Croatian: Odobrenja za stavljanje lijeka u promet povučena su od strane nositelja odobrenja u nekoliko država članica iz komercijalnih razloga i samo je formulacija tableta od 200 mg još uvijek dostupna u EGP.
English: Uncertainties still remain about the liver toxicity mechanism of ketoconazole.
Croatian: Još uvijek ostaju nedoumice glede mehanizma jetrene toksičnosti ketokonazola.
English: Ketoconazole 20mg/ml oral suspension and ketoconazole 100mg tablet formulations are no longer authorised in any EEA Member State.
Croatian: Ketokonazol 20 mg/ml peroralna suspenzija i ketokonazol 100 mg tablete nisu više odobrene u državama članicama EGP.
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Croatian: Prilog II Znanstveni zaključci i razlozi za suspenziju odobrenja za stavljanje lijeka u promet
English: Ketoconazole was first registered as tablets and oral suspension in December 1980.
Croatian: Ketokonazol je prvi put odobren u obliku tableta i suspenzije za peroralnu primjenu u prosincu 1980. godine.
English: In children, dosing recommendations are also broadly consistent with 100 mg daily for children weighing 15-30 kg and the same dose as for adults in children weighing more than 30 kg.
Croatian: U djece su preporuke o doziranju također uvelike dosljedne sa 100 mg dnevno za djecu težine 15 do 30 kg te pri istoj dozi kao i za odrasle za djecu težu od 30 kg.
English: Of note, while ketoconazole was available since 1982, fluconazole and itraconazole became later available in the 1990's.
Croatian: Potrebno je napomenuti da je ketokonazol dostupan od 1982 godine, a flukonazol i itrakonazol postali su dostupni kasnije u devedesetima.
English: This issue has not been mitigated because ketoconazole has not been used as an active comparator for newer drugs since 2001.
Croatian: Problem nije umanjen jer se ketokonazol nije koristio kao djelatni usporedni lijek za novije lijekove od 2001. godine.
English: Benefit -risk balance
Croatian: Omjer dobrobiti i rizika
English: It was also considered that no restrictive use could be adequately substantiated.
Croatian: Također se smatralo da nije moguće na odgovarajući način potvrditi ograničenu potvrdu.
English: Efficacy studies of ketoconazole on Malassezia folliculitis, Pityriasis versicolor, Tinea Capitis and Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis, and Tinea Manuum were scarce.
Croatian: Ispitivanja djelotvornosti ketokonazola na Malassezia folliculitis, Pityriasis versicolor, Tinea Capitis i Tinea Barbae, Tinea Corporis, Tinea Cruris, Tinea Pedis te Tinea Manuum bila su nedostatna.
English: In addition, a literature review retrieved more than 100 publications related to hepatotoxicity of ketoconazole.
Croatian: Pored toga, pregledom literaturnih podataka nađeno je više od 100 publikacija povezanih s hepatotoksičnosti ketokonazola.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CHMP recommends the suspension of the Marketing Authorisations for all medicinal product(s) referred to in Annex I. The conditions for the lifting of the suspension of the Marketing Authorisation(s) are set out in Annex III.
Croatian: Stoga u skladu s člankom 116 Direktive 2001/83/EZ, CHMP preporučuje suspenziju odobrenja za stavljanje lijeka u promet za sve lijekove koji su navedeni u prilogu I.
English: Treatment duration ranges from 5 consecutive days (vaginal candidosis) to up to 6 months for systemic fungal infections such as paracoccidioidomycosis and histoplasmosis.
Croatian: Trajanje liječenja varira od 5 uzastopnih dana (vaginalna kandidoza) do 6 mjeseci za sistemske gljivične infekcije kao pto je parokokcidiomikoza i histoplazmoza.
English: The experts unanimously agreed that there was no scientific evidence to support the MAH's revised indication proposal.
Croatian: Stručnjaci su se jednoglasno složili da nema znanstvenog dokaza koji bi podržao prijedlog revidiranih indikacija od strane nositelja odobrenja.
English: Overall, although hepatotoxicity is a class effect of azoles, the quantitative and qualitative aspects of the hepatotoxicity of ketoconazole are of particular concern.
Croatian: Općenito, iako je hepatotoksičnost učinak klase azola, kvantitativni i kvalitativni aspekti hepatotoksičnosti ketokonazola su posebice važni.
English: The CHMP was requested to give its opinion on whether the marketing authorisations for medicinal products containing ketoconazole for oral use, and associated names should be maintained, varied, suspended or withdrawn.
Croatian: Od CHMP-a se tražilo da dadne svoje mišljenje o tome da li odobrenja za stavljanje lijekova u promet koji sadrže ketokonazol za peroralnu primjenu i povezana imena treba odrćati, izmijeniti, suspendirati ili povući.
English: Infections of the skin, hair, and mucosa, induced by dermatophytes and/or yeasts that cannot be treated topically because of the site or the extent of the lesion or deepinfection of the skin.
Croatian: Infekcije kože, kose i sluznice izazvane dermatofitima i/ili kvascima koje se ne mogu liječiti topikalno zbog mjesta ili stupnja lezije ili duboke infekcije kože.
English: Finally, the SAG recognised that ketoconazole could potentially be used as a last treatment option in some very rare cases.
Croatian: Naposljetku, SAG je potvrdio da bi se ketokonazol mogao koristiti kao posljednja opcija liječenja u nekim vrlo rijetkim slučajevima.
English: In view of the above, the French Agency considered in June 2011 that the benefit-risk balance of oral ketoconazole was negative, suspended the existing marketing authorisations in France and informed the healthcare professionals and the public of its conclusions.
Croatian: U svjetlu navedenog, francuska je Agencija smatrala u lipnju 2011. da je omjer dobrobiti i rizika za peroralni ketokonazol negativan, suspendirala postojeća odobrenja za stavljanje lijeka u promet u Francuskoj i obavijestila zdravstvene djelatnike i javnost o svojim zaključcima.
English: Seven fatal/life-threatening cases were reported with event dates after 2006 i.e., after the CCDS update that contained substantial hepatotoxicity-related revisions.
Croatian: Sedam po život opasnih slučajeva prijavljeno je s događajima koji su datirali nakon 2006. tj. nakon ažuriranja CCDS-a koji je sadržavao značajne revzije povezane s hepatotoksičnosti.
English: In addition, the use of ketoconazole in those cases would likely require a long term or repeated treatment which would be of concern for the SAG given the hepatotoxicity profile of the compound.
Croatian: Osim toga, upotreba ketokonazola u tim slučajevima vjerojatno će zahtijevati dugoročno ili ponovljeno liječenje koje bi moglo biti razlog za zabrinutost za SAG s obzirom na profil hepatotoksičnosti ketokonazola.
English: The potential for hepatotoxicity is a class effect of azole antifungals and has been long reported for ketoconazole in numerous nonclinical and clinical references.
Croatian: Potencijal za hepatotoksičnost je klasa učinka azolnih lijekove protiv gljivica i već je odavno prijavljena za ketokonazol u brojnim nekliničkim i kliničkim referencama.
English: Given its level of efficacy and its poor distribution in the central nervous system, the use of ketoconazole in systemic mycoses might expose patients to sub-optimal management, as translated in the therapeutic guidelines.
Croatian: S obzirom na razinu djelotvornosti i njegovu slabu distribuciju u središnjem živčanom sustavu, upotreba ketokonazola u sistemskim mikozama može izložiti pacijenta suboptimalnom liječenju kako se to tumači u terapijskim smjernicama.
English: Therefore, fungal meningitis should not be treated with oral ketoconazole.
Croatian: Stoga se gljivični meningitis ne smije liječiti peroralnim ketokonazolom.
English: In addition, the claimed indications concern superficial fungal infections which are mainly confined to skin involvement (also mucous membranes for CMC), and while the social burden/inconvenience of this type of infections is not denied, the fact that they are mostly benign is also per se to be balanced with the level of hepatotoxicity of the drug.
Croatian: Pored toga, navedene indikacije odnose se na površinske gljivične infekcije koje su uglavnom ograničene na kožu (kao i na sluznice za CMC) i dok se ne poriče društveni teret/neprikladnost ovog tipa infekcija, činjenica da su uglavnom dobroćudne također se mora sama po sebi uravnotežiti s razinom hepatotoksičnosti lijeka.
English: Based on this analysis, the point-estimate risk, in terms of the commonly-used Frequency Categories in the Summary of Product Characteristics (SmPCs), was “Common” (≥ 1/100 to < 1/10) for any Hepatic Function Test result being abnormal, and “Rare” (≥ 1/10,000 to < 1/1,000) for Hepatitis and/or Jaundice.
Croatian: Na temelju ove analize, istaknuti rizik u smislu standardnih korištenih kategorija učestalosti u Sažetku opisa svojstava lijeka (SmPCs), bio je „Često” (≥ 1/100 i < 1/10) za bilo koji nenormalni test jetrene funkcije i „Rijetko” (≥ 1/10 000 i < 1/1 000) za hepatitis i/ili žuticu.
English: The incidence of symptomatic hepatic reactions in the setting of treatment with oral ketoconazole was estimated in several epidemiology studies to be between 1/10,000 and 1/15,000 patients.
Croatian: Incidencija simptomatskih jetrenih reakcija u postavljanju liječenja peroralnim ketokonazolom procijenjena je u nekoliko epidemiološkihispitivanja na između 1/10 000 i 1/15 000 pacijenata.
English: From 1985 to 2010, around a hundred cases of hepatic disorders with oral ketoconazole were reported to the French Pharmacovigilance Regional Centres network, including hepatitis NOS, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, hepatic failure.
Croatian: Od 1985. do 2000. godine oko stotinu slučajeva jetrenih poremećaja s peroralnim ketokonazolom prijavljeni su mreži francuskih regionalnih centara za farmakovigilanciju, uključujući i druge nespecificirane jetrene slučajeve, toksični hepatitis, citolitički hepatitis, kolestatski hepatitis, zatajenje jetre.
English: The SAG was also of the opinion that the pharmacokinetics / pharmacodynamics profile of ketoconazole presents similar limitations as the other systemic antifungal treatments (i.e. limited absorption, distribution) and the drug-drug interaction profile could be even worse.
Croatian: SAG je također smatrao da farmakokinetički/farmakodinamički profil ketokonazola prikazuje slična ograničenja s obzirom na liječenje drugim sistemskim antifungicima (tj. ograničena apsorpcija, distribucija), a profil interakcija između lijekova mogao bi biti čak i gori.