natgillin/translations-raw huggingface dataset:
The maximum dose should not be exceeded. 
Najviša doza ne smije biti prekoračena.
Over 80% of male dogs above 5 years of age are affected. 
Javlja se u preko 80% muških pasa preko 5 godina starosti.
Tablets can be given either directly into the mouth or with food. 
Tablete se mogu dati ili direktno u usta ili s hranom.
*No data are available for dogs less than 3 kg bodyweight 
* Nema dostupnih podataka za pse manje od 3 kg tjelesne mase.
Wash hands after administration. 
Oprati ruke nakon aplikacije
Dogs (male) 
Psi (muški)
If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary. 
Ukoliko je klinički odgovor značajno kraći od očekivanog, potrebna je ponovna procjena postavljene dijagnoze.
This binding is reversible and not affected by other substances known to specifically bind to albumin. 
Ovo je vezanje reverzibilno i nije pod utjecajem drugih tvari za koje se zna da se specifično vežu za albumin.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. 
Nositelj odobrenja za stavljanje u promet mora obavijestiti Europsku komisiju o planovima stavljanja u promet veterinarsko medicinskog proizvoda odobrenog ovom odlukom.
Ask your veterinary surgeon how to dispose of medicines no longer required. 
Pitajte vašeg veterinara kako odlagati proizvod koji vam više nisu potrebni.
Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine. 
Osateron se eliminira u 14 dana uglavnom putem fecesa kroz bilijarnu ekskreciju (60%) i u manjoj mjeri (25%) urinom.
This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders. 
Dovodi do mnoštva ne specifičnih kliničkih znakova kao što su bol u abdomenu, poteškoće pri defekaciji ili mokrenju, pojave krvi u urinu ili motoričkih poremećaja.
The onset of clinical response to treatment is usually seen within 2 weeks. 
Početak kliničkog odgovora se obično uočava unutar 2 tjedna.
No adverse effects on semen quality have been observed. 
Nuspojave na kvalitetu sjemena nisu primijećene.
Carmellose calcium 
Kalcijev karmelozat
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. 
U kliničkim pokusima tretman veterinarsko medicinskim proizvodom nije prekidan a sve su se životinje oporavile bez ikakve posebne terapije.
After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax about 2 hours) and undergoes a first-pass effect mainly in the liver. 
Nakon peroralne aplikacije putem hrane psima, osateron acetat se brzo apsorbira (Tmax oko 2 sata) i podliježe efektu prvog prolaza uglavnom u jetrima.
In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. 
U ženki laboratorijskih životinja osateron acetat je uzrokovao ozbiljne nuspojave na reprodukcijske funkcije.
Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l. 
Petnaest dana nakon zadnje aplikacije srednja koncentracija u plazmi je oko 6,5 µg/L.
It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate. 
On kompeticijski inhibira vezanje androgena na njihove receptore u prostati i blokira transport testosterona do prostate.
Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011 
Datum posljednjeg produljenja odobrenja: 19/12/2011
Benign prostatic hypertrophy (BPH) is a natural consequence of ageing. 
Benigna hipertrofija prostate (BPH) je prirodna posljedica starenja.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju - 3 godine 6.4.
Osaterone acetate 
Osateron acetat
Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common. 
Prolazne promjene ponašanja poput povišene ili umanjene aktivnosti ili izrazitije društvenosti su česte.
An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration. 
Ispitivanjima predoziranja (do 1,25 mg / kg t.m. za 10 dana ponovljena nakon mjesec dana) nisu dokazane nuspojave sa izuzetkom sniženja koncentracije kortizola u plazmi.
Do not use after the expiry date stated on the blister after “EXP” 
Ne koristiti poslije isteka roka valjanosti naznačenog na blisteru poslije {EXP}
Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm. 
Okrugla, bijela bikonveksna tableta veličine 5,5 mm, 7 mm, 9 mm i 12 mm
The clinical response persists for at least 5 months after treatment. 
Klinički odgovor traje najmanje 5 mjeseci nakon kraja primjene.
VIRBAC Tierarzneimittel GmbH Rögen 20 
VIRBAC Tierarzneimittel GmbH West Rögen 20
After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination. 
Poslije ponovljene aplikacije osateron acetata u dozi od 0,25 mg/kg/dan tijekom 7 dana, faktor akumulacije je oko 3-4 bez promjene u stopi apsorpcije ili eliminacije.
Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin. 
Osateron acetata i njegov glavni metabolit vežu se za proteine plazme (prvi oko 90%, drugi oko 80%) uglavnom za albumin.
Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur. 
Veterinar treba napraviti ponovnu procjenu 5 mjeseci poslije zadnje primjene ili ranije, ukoliko se klinički znakovi vrate.
All these adverse reactions are reversible without any specific treatment. 
Sve ove nuspojave nestaju bez ikakvog specifičnog liječenja.
Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials. 
U pasa s bolesti jetre savjetuje se oprez jer neškodljivost kod primjene proizvoda u ovakvih pasa nije ispitana i jer je tretman nekih pasa sa oboljelom jetrom tijekom kliničkih pokusa rezultirao sa reverzibilnim povišenjem ALT i AST.
A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. 
Jednokratna peroralna doza od 40 mg osateron acetata u muškaraca bila je praćena mjestimičnim umanjenjem FSH, LH i testosterona što je vraćeno za 16 dana.
BPH is a development and enlargement of the prostate due to the male hormone testosterone. 
BPH je razvoj i povećanje prostate uzrokovana muškim hormonom testosteronom.
Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism. 
Psi pod stresom (npr. post-operacijskim) ili oni sa hipoadrenokorticizmom bi trebali biti pod odgovarajućim nadzorom.
Elimination is slow with a mean half-life (T½) of about 80 hours. 
Eliminacija je spora sa srednjim vremenom (T1/2) od oko 80 sati.
Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane. 
Prolazne nuspojave se mogu javiti u vidu promjena na krznu, gubitak dlake ili promjene na dlakama koje se javljaju jako rijetko nakon primijene Ypozana.
After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l. 
Poslije doze od 0,25 mg/kg/dan srednja maksimalna koncentracija (Cmax) u plazmi je oko 60µg/L.
Use with caution in dogs with a history of liver disease. 
Koristiti uz oprez u pasa koji u anamnezi imaju oboljenje jetre.
The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone. 
Odgovor na test stimulacije adrenokortikotropnog hormona (ACTH) mogao bi također biti suprimiran na nekoliko tjedana poslije aplikacije osaterona.
In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
- rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active. 
Pretvorba osateron acetata odvija se do njegova glavnog 15β-hydroksi metabolita koji je također farmakološki aktivan.
Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity. 
Osateron acetat je steroid kemijski srodan progesteronu, i kao takav ima jaku progestagensku i protuandrogenu aktivnost.
Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone). 
Osateron je protuandrogeni steroid koji inhibira efekte prekomjerne produkcije muškog hormona (testosterona).
OÜ ZOOVETVARU Uusaru 5 
OÜ ZOOVETVARU Pärnasalu 31
Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows: 
Aplicirati 0,25 - 0,5 mg osateron acetata po kilogramu tjelesne mase, jednom dnevno, tokom 7 dana kao što slijedi:
REGARDING SUPPLY OR USE 
POGLEDU OPSKRBE I PRIMJENE
Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity. 
Također, glavni metabolit osateron acetata (15β-hydroksilirani -osateron acetat) ima protu-androgenu aktivnost.
PACKAGE SIZE 7 tablets. 
VELIČINA PAKOVANJA 7 tableta
Number of tablet per day 
Broj tableta na dan Trajanje terapije
NL-3771 AH-Barneveld Tel: 31 (0) 342 427 100 
NL-3771 ND-Barneveld Tel: 31 (0) 342 427 100
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/ ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration. 
Može doći do prolaznog umanjenja kortizola u plazmi što može trajati nekoliko tjedana od primjene proizvoda.
Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product. 
Stoga se ženama u plodnom razdoblju savjetuje da izbjegavaju kontakt sa proizvodom ili da tijekom njegove aplikacije nose rukavice za jednokratnu primjenu.
Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms. 
Osateron acetat inhibira efekte suviška testosterona preko više mehanizama.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED : 
14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
15 mg tablet 
15 mg tableta
MANUFACTURER'S BATCH NUMBER Batch {number} 
17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR 
13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA
A transient reduction in plasma cortisol occurs in most treated animals. 
U većine tretiranih životinja zapaža se prolazna promjena kortizola u plazmi.
Treatment of benign prostatic hypertrophy (BPH) in male dogs. 
Liječenje benigne hipertrofije prostate (BPH) u muških pasa.
Marketing authorisation holder and manufacturer: 
Nositelj odobrenja za stavljanje u promet i proizvođač
1.875 mg tablet 
1,875 mg tableta
Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly. 
Druge nuspojave uključujući prolazno povraćanje i/ili proljev, poliuriju/polidipsiju, letargiju javljaju se rijetko.
Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare). 
Vrlo često dolazi do prolaznih promjena u apetitu, bilo da je riječ o povećanju apetita (jako često) ili o smanjenju apetita (jako rijetko).
Lactose monohydrate 
Lakotoza monohidrat
A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product. 
Odluka o ponovnoj primjeni u tom trenutku ili kasnije trebala bi biti donijeta na osnovu veterinarskog pregleda i procjene rizika i dobiti od proizvoda.
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription. 
U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo Samo za primjenu na životinjama
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use. 
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
VIRBAC NEDERLAND BV Postbus 313 
VIRBAC NEDERLAND BV Hermesweg 15
PHARMACEUTICAL FORM Tablet. 
OBLIK Tableta
Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients: 
Svaka tableta sadržava: 1,875 mg, 3,75 mg, 7,5 mg ili 15 mg osateron acetata Pomoćne tvari:
A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the medicine. 
Odluka o ponovnoj primjeni u tom trenutku ili kasnije trebala bi biti donijeta na osnovu veterinarskog pregleda i procjene rizika i dobiti u odnosu na proizvod.
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 
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
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials. 
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.
SPECIAL STORAGE CONDITIONS Not applicable 
11. POSEBNI UVJETI ČUVANJA Nije primjenljivo
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH 
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U
VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrance 
VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrancuska
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) 
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)
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use. 
NAČIN I PUT(EVI) PRIMJENE Peroralna primjena
7.5 mg tablet 
7,5 mg tableta
3.75 mg tablet 
3,75 mg tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg 
PODACI NA VANJSKOM PAKOVANJU Kutija-15 mg
Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly. 
Druge nuspojave uključujući prolazno povraćanje i/ili proljev, poliuriju/polidipsiju, letargiju nisu toliko česte.
1ère avenue - 2065 m - LID 06516 Carros France 
1ère avenue - 2065 m - LID 06516 Carros Francuska
3 to 7.5 kg* 
3 do 7,5 kg*
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 1.875 mg 
PODACI NA VANJSKOM PAKOVANJU Kutija-1,875 mg
ATC vet code : QG04C X 
Farmakoterapijska grupa: Proizvodi za primjenu kod benigne hipertrofije prostate ATCvet kod: QG04C X
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 1.875 mg 
ILI TRAKAMA BLISTER-1,875 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 3.75 mg 
PODACI NA VANJSKOM PAKOVANJU Kutija-3,75 mg
7.5 to 15 kg 
7,5 do 15 kg
30 to 60 kg 
30 do 60 kg
15 to 30 kg 
15 do 30 kg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 7.5 mg 
ILI TRAKAMA BLISTER-7,5 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 7.5 mg 
PODACI NA VANJSKOM PAKOVANJU Kutija-7,5 mg
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR 
12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH
RELEASE 
NUSPOJAVE
REGARD TO SAFE AND EFFECTIVE USE 
POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE PROIZVODA Nije primjenjivo
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 15 mg 
ILI TRAKAMA BLISTER-15 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 3.75 mg 
ILI TRAKAMA BLISTER-3,75 mg
D. STATEMENT OF THE MRLs Not applicable 
IZVJEŠĆE O MRL
Pregelatinised starch 
Pregelirani škrob
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) 
Svaka tableta sadrži: 1,875 mg, 3,75 mg, 7,5 mg ili 15 mg osateron acetata
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 15 mg tablete za pse
Special precautions for use in animals 
4.5 Posebne mjere predostrožnost za primjenu Posebne mjere predostrožnost za primjenu na životinjama
E-08950 - Esplugues de Llobregat (Barcelona) Tel: + + 34 93 470 79 40 
ES-8950 Esplugues de Llobregat (Barcelona).
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 1,875 mg tablete za pse
Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus (P.O.Box 40261, 6302 Larnaca, Cyprus) Tel: +357 24813333 
LTD 25-27 Dimostheni Severi, 1080 CY-1080 Nicosia - CYPRUS Τηλ: + 357 22456117
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA
WITHDRAWAL PERIOD(S) 
INDIKACIJA(E)
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION 
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
NAME OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A. 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Virbac S.A.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 7,5 mg tablete za pse
Luxembourg/Luxemburg VIRBAC BELGIUM S.A. B-3001 Leuven Tel: 32 (0) 10 47 06 35 
B-1300 WAVRE Tel: 32 (0) 10 47 06 35
MARKETING AUTHORISATION HOLDER VIRBAC S.A. 
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET VIRBAC S.A.
PHARMACOLOGICAL PROPERTIES 
FARMAKOLOŠKASVOJSTVA
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Virbac S.A. 
15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Virbac S.A.
Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases. 
Feminizacijski sindrom s hiperplazijom mliječne žlijezde povezan s laktacijom, nije tako čest.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
12. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA YPOZANE 3,75 mg tablete za pse
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 
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/001 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/001
MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/004 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/004
Treatment duration 
ROK VALJANOSTI
MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/002 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/002
Name and address of the manufacturer responsible for batch release Virbac S.A. 
ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet: Virbac S.A.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/003 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/068/003
YPOZANE tablets to be administered 
UPUTA O VMP YPOZANE
Systemic fungal infections. 
Sistemske gljivične infekcije.
Particular attention was dedicated to the issue of hepatotoxicity. 
Posebna pozornost posvećena je pitanju hepatotoksičnosti.
At the request of the CHMP, an Anti-Infective Scientific Advisory group (SAG) meeting was held on 3 September 2012. 
Na zahtjev CHMP-a, održan je sastanak Antiinfektivne znanstvene, savjetodavne skupine (SAG) 3. rujna 2012. godine.
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. 
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.
Several potential mechanisms for this toxicity have been identified but uncertainties still remain. 
Identificirano je nekoliko potencijalnih mehanizama ove toksičnosti ali nesigurnost je i dalje prisutna.
Divergent positions are presented in Appendix III. 
U prilogu III prikazana su različita stajališta.
Ketoconazole does not penetrate well in the Central Nervous System. 
Ketokonazol ne prodire dobro u središnji živčani sustav.
In parallel, on 1 July 2011, France triggered a referral under Article 31of Directive 2001/83/EC, as amended. 
Usporedno s tim, 1. srpnja 2011. godine Francuska je potaknula procjenu u skladu s člankom 31 Direktive 2001/83/EZ i njenim izmjenama.
In Europe, oral formulations of ketoconazole are currently approved in 20 Member States as well as in Iceland and Norway. 
Europi su peroralne formulacije ketokonazola trenutno odobrene u 20 država članica kao i u na Islandu i u Norveškoj.
The marketing authorisation holder extensively discussed the mechanism of hepatotoxicity, widely supported with literature data from 1986 to 2007. 
Nositelji odobrenja intenzivno su raspravljali o mehanizmu hepatotoksičnosti koji je široko poduprt literaturnim podacima od 1986. do 2007. godine.
This was followed by the registration of topical pharmaceutical forms such as cream /ointment/shampoo. 
Nakon toga uslijedila je registracija farmaceutskih oblika poput kreme/masti/šampona.
The therapeutic indications included in the current version of the Company Core Data Sheet (CCDS) of the originator product are as follows: 
Terapijske indikacije uključene u trenutnu verziju Ključnih podataka tvrtke (CCDS) originatorova lijeka su sljedeće:
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. 
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.
The level of risk appears to be higher than that observed with other antifungal agents. 
Čini se da je razina viša od one uočene s drugim antifungicima.
Characteristics of acute injuries mainly included cytolysis and may lead to serious outcomes including liver transplantation. 
Karakteristike akutnih ozljeda uglavnom su uključivale citolizu i mogu uzrokovati ozbiljne ishode uključujući i transplantaciju jetre.