FrancophonIA/ELRC3.0 huggingface dataset:
English: Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active.
Slovenian: Osateronijev acetat se pretvori v glavni 15β-hidroksiliran metabolit, ki je prav tako farmakološko aktiven.
English: 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.
Slovenian: Pri psih se po peroralnem dajanju s hrano osateronijev acetat hitro absorbira (Tmax okoli 2 uri) in je v glavnem v jetrih izpostavljen učinku prvega prehoda.
English: BPH is a development and enlargement of the prostate due to the male hormone testosterone.
Slovenian: BHP je razvoj in povečanje prostate zaradi moškega hormona testosterona.
English: Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Slovenian: Odmerite 0,25 - 0,5 mg osateronijevega acetata na kilogram telesne teže enkrat na dan 7 dni na naslednji način:
English: The onset of clinical response to treatment is usually seen within 2 weeks.
Slovenian: Nastop kliničnega odgovora na zdravljenje opazite v 2 tednih.
English: After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Slovenian: Po odmerku 0,25 mg/kg/dan je srednja največja koncentracija (Cmax) v plazmi okoli 60 µg/l.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Serija {številka}
English: Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity.
Slovenian: Osateronijev acetat je steroid, ki je kemijsko podoben progesteronu in ima zato močno progestagensko in močno protiandrogeno delovanje.
English: All these adverse reactions are reversible without any specific treatment.
Slovenian: Vsi neželeni učinki izginejo brez specifičnega zdravljenja.
English: EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003 EU/2/06/068/004
Slovenian: EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003
English: Behavioural changes such as modification of dog's activity or more social behaviour are common.
Slovenian: Pogoste so spremembe vedenja, na primer spremenjena dejavnost psa ali bolj družabno vedenje.
English: Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare).
Slovenian: Zelo pogosto se pojavi prehodna sprememba apetita, bodisi povečanega (zelo pogosto) ali zmanjšanega (zelo redko).
English: Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Slovenian: Osateron je steroidni antiandrogen, ki inhibira učinke presežne proizvodnje moškega hormona (testosterona).
English: Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity.
Slovenian: Tudi glavni metabolit osateronijevega acetata (15β-hidroksiliran osateronijev acetat) ima protiandrogeno delovanje.
English: Number of tablet per day
Slovenian: Število tablet na dan Trajanje zdravljenja
English: 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.
Slovenian: Odločitev o ponovnem zdravljenju v tem ali kasnejšem trenutku mora temeljiti na veterinarskem pregledu upoštevajoč tveganje in koristi izdelka.
English: Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.
Slovenian: Farmakoterapevtska skupina: zdravila, ki se uporabljajo pri benigni hipertrofiji prostate.
English: In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Slovenian: Pri psih z BHP povezano s prostatitisom lahko zdravilo uporabljamo sočasno s protimikrobnimi zdravili.
English: 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.
Slovenian: Odločitev o ponovnem zdravljenju v tem ali kasnejšem trenutku mora temeljiti na veterinarskem pregledu upoštevajoč tveganje in koristi zdravila.
English: The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Slovenian: Tudi odgovor na test stimulacije adrenokortikotropnega hormona (ACTH) je lahko zmanjšan še nekaj tednov po zaužitju osaterona.
English: Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011
Slovenian: Datum podaljšanja dovoljenja za promet: 19/12/2011
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare).
Slovenian: Najpogosteje opaženi neželeni učinki so blaga in prehodna sprememba apetita, bodisi povečanega (zelo pogosto) ali zmanjšanega (zelo redko).
English: The onset of clinical response to treatment is usually seen within 2 weeks and persists for at least 5 months after treatment.
Slovenian: Prvi klinični odgovor na zdravljenje se pojavi v 2 tednih in traja vsaj 5 mesecev po zdravljenju.
English: Use with caution in dogs with a history of liver disease.
Slovenian: Pri psih s podatki o bolezni jeter uporabljajte previdno.
English: 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.
Slovenian: Enkraten peroralno zaužiti odmerek 40 mg osateronijevega acetata pri moških je v posameznih primerih povzročil znižanje koncentracije FSH, LH in testosterona, ki se je vrnila v običajno po 16
English: Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Slovenian: Pogoste so prehodne spremembe vedenja, na primer povečana ali zmanjšana dejavnost ali bolj družabno vedenje.
English: To be supplied only on veterinary prescription
Slovenian: Izdaja zdravila je le na veterinarski recept
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
Slovenian: 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: A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease of sexual hormones, reversible after 16 days.
Slovenian: Enkraten peroralno zaužiti odmerek 40 mg osateronijevega acetata pri moških je v posameznih primerih povzročil znižanje koncentracije spolnih hormonov, ki se je vrnila v običajno po 16 dneh.
English: ul.
Slovenian: A.
English: Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients:
Slovenian: Vsaka tablete vsebuje 1,875 mg, 3,75 mg, 7,5 mg ali 15 mg osateronijevega acetata
English: In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Če kdo nenamerno zaužije zdravilo, mora takoj poiskati zdravniško pomoč in zdravniku pokazati navodila za uporabo ali oznako na ovojnini.
English: The enlargement of mammary glands occurs less commonly and can be associated with lactaction in very rare cases.
Slovenian: Povečanje mlečnih žlez se pojavlja le občasno in jo v zelo redkih primerih lahko spremlja laktacija.
English: 15 mg tablet
Slovenian: 15 mg tablete
English: Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly.
Slovenian: Drugi neželeni učinki kot so prehodno bruhanje in/ali driska, povečana žeja, otrplost ali povečane mlečne žleze se pojavljajo redko.
English: 1.875 mg tablet
Slovenian: 1,875 mg tablete
English: Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly.
Slovenian: Drugi neželeni učinki, kot so prehodno bruhanje in/ali driska, poliurija/polidipsija ali letargija se pojavljajo redko.
English: - 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).
Slovenian: - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: 6.5 Nature and composition of immediate packaging Carton box containing one aluminium/aluminium blister with 7 tablets.
Slovenian: Zloženka, ki vsebuje pretisni omot (aluminij/aluminij) s 7 tabletami.
English: YPOZANE tablets to be administered
Slovenian: Tablete YPOZANE, ki jih je treba uporabiti
English: Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases.
Slovenian: Hiperplazija mlečnih žlez se pojavlja le občasno in jo v zelo redkih primerih lahko spremlja laktacija.
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)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
English: Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Slovenian: Ženske v plodni dobi naj se torej pri dajanju zdravila izogibajo stiku z njim, oziroma nosijo rokavice za enkratno uporabo.
English: Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Slovenian: Ženske v plodni dobi naj se torej pri dajanju zdravila izogibajo stiku z njim oziroma nosijo rokavice za enkratno uporabo.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
English: Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism.
Slovenian: Pojavi se lahko prehodno znižanje koncentracije kortizola v plazmi, ki se lahko nadaljuje še nekaj tednov po zaužitju zdravila Psi pod stresom (npr. po operaciji) ali tisti s hipoadrenokorticizmom morajo biti pod ustreznim nadzorom.
English: INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs.
Slovenian: INDIKACIJA(E) Zdravljenje benigne hipertrofije prostate pri psih samcih.
English: 3.75 mg tablet
Slovenian: 3,75 mg tablete
English: D. STATEMENT OF THE MRLs Not applicable
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
English: 7.5 mg tablet
Slovenian: 7,5 mg tablete
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Slovenian: IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA ODGOVOREN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 1.875 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 1,875 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 15 mg
English: Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Slovenian: Zdravljenje benigne hipertrofije prostate (BHP) pri psih samcih.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 1.875 mg osaterone acetate.
Slovenian: NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 1,875 mg osateronijevega acetata.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Virbac S.A.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Virbac S.A.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 7.5 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 7,5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 3.75 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 3,75 mg
English: Name and address of the manufacturer responsible for batch release Virbac S.A.
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije Virbac S.A.
English: VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrance
Slovenian: VIRBAC S.A.1ère avenue 2065 m - LID06516 Carros Francija
English: 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.
Slovenian: Pri psih s podatki o bolezni jeter uporabljajte previdno, saj pri teh psih varnost uporabe zdravila še ni raziskana.
English: 3 to 7.5 kg
Slovenian: 3 do 7,5 kg
English: 7.5 to 15 kg
Slovenian: 7,5 do 15 kg
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Samo za živali - oskrba le na podlagi veterinarskega recepta.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
English: 15 to 30 kg
Slovenian: 15 do 30 kg
English: 30 to 60 kg
Slovenian: 30 do 60 kg
English: Treatment of benign prostatic hypertrophy in male dogs.
Slovenian: Zdravljenje benigne hipertrofije prostate pri psih samcih.
English: A transient reduction in plasma cortisol occurs in most treated animals.
Slovenian: Pri večini zdravljenih živali pride zaradi reverzibilnega antiglukokortikoidnega učinka osaterona do prehodnega zmanjšanja plazemskega kortizola.
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 7.5 mg osaterone acetate
Slovenian: NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 7,5 mg osateronijevega acetata
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 1,875 mg tablete za pse
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 15 mg tablete za pse
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 3.75 mg osaterone acetate
Slovenian: NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 3,75 mg osateronijevega acetata
English: STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 15 mg osaterone acetate
Slovenian: NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 15 mg osateronijevega acetata.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 7,5 mg tablete za pse
English: 1ère avenue - 2065 m - LID 06516 Carros France
Slovenian: VIRBAC S.A. 1ère avenue - 2065 m - LID 06516 Carros Francija
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 1.875 mg
Slovenian: PRETISNI OMOT S 7 TABLETAMI S - 1,875 mg
English: Treatment duration
Slovenian: ZDRAVILA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 3.75 mg
Slovenian: PRETISNI OMOT S 7 TABLETAMI S - 3,75 mg
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 3.75 mg tablets for dogs Osaterone acetate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 3,75 mg tablete za pse
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/068/001
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 15 mg
Slovenian: PRETISNI OMOT S 7 TABLETAMI S - 15 mg
English: Lactose monohydrate
Slovenian: Laktoza monohidrat Škrob, predgelirani Kalcijev karmelozat Koruzni škrob Smukec
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/004
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/068/004
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/068/002
English: Carmellose calcium
Slovenian: 4.11 Karenca
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/068/003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/068/003
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER - 7.5 mg
Slovenian: PRETISNI OMOT S 7 TABLETAMI S - 7,5 mg
English: Divergent positions are presented in Appendix III.
Slovenian: Različna stališča so predstavljena v Prilogi III.
English: Particular attention was dedicated to the issue of hepatotoxicity.
Slovenian: Posebno pozornost so namenili vprašanju hepatotoksičnosti.
English: It was also considered that no restrictive use could be adequately substantiated.
Slovenian: Prav tako je menil, da ni mogoče zadostno utemeljiti nobene omejene uporabe.
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.
Slovenian: Ti primeri izhajajo iz starih publikacij (od 1980 do 1986), medtem ko se pričakuje, da je v več kot 25 letih prišlo do sprememb v obravnavi bolnikov.
English: In parallel, on 1 July 2011, France triggered a referral under Article 31of Directive 2001/83/EC, as amended.
Slovenian: Vzporedno je Francija 1. julija 2011 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES, kot je bila spremenjena.
English: Positive rechallenge was noted in some cases.
Slovenian: V nekaterih primerih so opazili pozitivno provokacijo.
English: In Europe, oral formulations of ketoconazole are currently approved in 20 Member States as well as in Iceland and Norway.
Slovenian: V Evropi so peroralne formulacije ketokonazola trenutno odobrene v 20 državah članicah ter na Islandiji in Norveškem.
English: Several potential mechanisms for this toxicity have been identified but uncertainties still remain.
Slovenian: Ugotovili so več potencialnih mehanizmov za to toksičnost, vendar so še vedno prisotne nejasnosti.
English: This was followed by the registration of topical pharmaceutical forms such as cream /ointment/shampoo.
Slovenian: Temu je sledila registracija topičnih farmacevtskih oblik, kot so krema/mazilo/zdravilni šampon.
English: The level of risk appears to be higher than that observed with other antifungal agents.
Slovenian: Stopnja tveganja je videti večja kot pri drugih antimikotikih.
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.
Slovenian: Skladno s členom 116 Direktive 2001/83/ES je CHMP priporočil začasni umik dovoljenj za promet z vsemi zdravili iz Priloge I. Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom so navedeni v Prilogi III.
English: However, the experts unanimously agreed that these cases were anecdotal and that there was no scientific evidence available to support this claim.
Slovenian: Vendar so se strokovnjaki soglasno strinjali, da so ti primeri anekdotični in da ni nobenih znanstvenih dokazov, ki bi podprli to trditev.
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.
Slovenian: Priporočila za odmerjanje pri odraslih so večinoma usklajena v vseh državah članicah, tj. 200 mg na dan, kar se lahko poveča na 400 mg, če ne pride do zadostnega odziva.
English: Ketoconazole 20mg/ml oral suspension and ketoconazole 100mg tablet formulations are no longer authorised in any EEA Member State.
Slovenian: Ketokonazol 20 mg/ml peroralna suspenzija in ketokonazol 100 mg tableta nista več odobreni v nobeni državi članici EGP.
English: Overall summary of the scientific evaluation of ketoconazole-containing products for oral use (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za peroralno uporabo, ki vsebujejo ketokonazol (glejte Prilogo I)
English: Ketoconazole was first registered as tablets and oral suspension in December 1980.
Slovenian: Ketokonazol je bil prvič registriran decembra 1980 v obliki tablet in peroralne suspenzije.
English: Finally, the SAG recognised that ketoconazole could potentially be used as a last treatment option in some very rare cases.
Slovenian: Na koncu je skupina potrdila, da bi lahko ketokonazol uporabljali kot zadnjo možnost zdravljenja pri nekaterih zelo redkih primerih.
English: In the literature, incidence of acute injuries is variable and ranged from 1/2000 patients exposed to 12%.
Slovenian: V literaturi je incidenca akutnih poškodb različna, saj je bil njen razpon od 1/2000 izpostavljenih bolnikov do 12 %.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ketoconazole-containing products for oral use;
Slovenian: • odbor je obravnaval napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila za peroralno uporabo, ki vsebujejo ketokonazol;
English: The marketing authorisation holder extensively discussed the mechanism of hepatotoxicity, widely supported with literature data from 1986 to 2007.
Slovenian: Imetnik dovoljenja za promet z zdravilom je izčrpno preučil mehanizem hepatotoksičnosti, kar je obširno podprl s podatki iz literature, objavljene med letoma 1986 in 2007.
English: In general, the clinical studies submitted to support the efficacy of oral ketoconazole were limited and not conducted in line with the current guidelines.
Slovenian: Na splošno so bile klinične študije, predložene kot podpora za učinkovitost peroralnega ketokonazola, omejene in niso bile izvedene v skladu s trenutnimi smernicami.
English: Within the EU, the indications approved for ketoconazole-containing products vary amongst Members States.
Slovenian: V EU se indikacije, odobrene za zdravila, ki vsebujejo ketokonazol, med državami članicami lahko razlikujejo.
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.
Slovenian: Odbor CHMP je zaprosila, naj poda svoje mnenje o tem, ali naj se dovoljenja za promet z zdravili za peroralno uporabo, ki vsebujejo ketokonazol, in povezanimi imeni, ohranijo, spremenijo, začasno umaknejo ali ukinejo.
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.
Slovenian: O sedmih smrtnih/smrtno nevarnih primerih so poročali po letu 2006, tj. po posodobitvi CCDS, ki je vsebovala obsežne revizije glede hepatotoksičnosti.
English: Topical forms have not been considered in the present review.
Slovenian: Topične oblike niso vključene v pričujoči pregled.
English: In 2011, a review performed by the French National Competent Authority concluded that spontaneous reports and literature data indicate that oral ketoconazole is associated with a high level of liver toxicity.
Slovenian: Leta 2011 je pregled, ki ga je opravil francoski nacionalni pristojni organ, pokazal, da spontana poročila in podatki iz literature kažejo, da je peroralni ketokonazol povezan s visoko stopnjo jetrne toksičnosti.
English: In addition, a literature review retrieved more than 100 publications related to hepatotoxicity of ketoconazole.
Slovenian: Poleg tega je pregled literature odkril več kot 100 publikacij, povezanih s hepatotoksičnostjo ketokonazola.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je umaknil dovoljenja za promet z zdravilom v več državah članicah zaradi poslovnih razlogov, zato je v prostoru EGP na voljo samo še formulacija 200-miligramske tablete.
English: This issue has not been mitigated because ketoconazole has not been used as an active comparator for newer drugs since 2001.
Slovenian: Težave niso zmanjšali, saj ketokonazol ni uporabljan kot primerjalna zdravilna učinkovina pri novejših zdravilih od leta 2001.