FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Slovenian: Smernica CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) nakazuje, da je delež zdravljenih živali v čredi lahko na voljo iz informacij v dokumentaciji, kot so podatki terenskih preskušanj ali podatki iz znanstvene literature.
English: PECsoil = 40 x 1 x 140 x 1.8 x 170 x 0.38 x 1000 =
Slovenian: PKOtla = 40 x 1 x 140 x 1,8 x 170 x 0,38 x 1000 =
English: The value of the resulting PECsoil determines whether or not a Phase II environmental risk assessment is required.
Slovenian: Vrednost izračunane PKOtla določa, ali je potrebna II.
English: 3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. and Blanco A. (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
Slovenian: 3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. in Blanco A. (2007) Evaluation of Mass and
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Slovenian: Smernica CVMP o presoji vplivov zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL8 in GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) podaja privzete vrednosti za delež živali v zdravljeni čredi, ki ga uporabimo pri izračunu PKOtla.
English: 1500 x 10000 x 0.05 x 35 x 0.5 Dairy cow PECsoil = 40 x 1 x 425 x 1 x 170 x 0.38 x 1000=
Slovenian: 1500 x 10000 x 0,05 x 35 x 0,5 Krava molznica PKOtla = 40 x 1 x 425 x 1 x 170 x 0,38 x 1000 =
English: 1500 x 10000 x 0.05 x 18 x 0.5 Cattle (> 2 years) PECsoil = 40 x 1 x 450 x 1 x 170 x 0.38 x 1000=
Slovenian: 1500 x 10000 x 0,05 x 18 x 0,5 Govedo (> 2 let) PKOtla = 40 x 1 x 450 x 1 x 170 x 0,38 x 1000 =
English: 1500 x 10000 x 0.05 x 10 x 1 Cattle (0 - 1 year) PECsoil = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
Slovenian: 1500 x 10000 x 0,05 x 10 x 1 Govedo (0-1 leta) PKOtla = 40 x 1 x 200 x 1 x 170 x 0,38 x 1000 =
English: As this is below the Phase II trigger value of 100 µg/kg no Phase II environmental risk assessment is required.
Slovenian: fazo, ki znaša 100 µg/kg, II.
English: Marixino should be given once a day at the same time every day.
Slovenian: Zdravilo Marixino se daje enkrat dnevno, vsak dan ob istem času.
English: To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Slovenian: Da se preprečijo neželeni učinki, se odmerek zdravila Marixino v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg; drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
English: What measures are being taken to ensure the safe and effective use of Marixino?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Marixino?
English: The name of the medicine was changed to Marixino on 9 August 2013.
Slovenian: Ime zdravila je bilo Dne 9 avgusta 2013 spremenjeno v Marixino.
English: The full EPAR for Marixino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Marixino je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 1 Previously known as Maruxa.
Slovenian: Prej znano kot Maruxa.
English: Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Slovenian: Marixino je zdravilo, ki se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo, tj. vrsto demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
English: Marixino memantine
Slovenian: Marixino memantin
English: Marixino is a ‘generic medicine'.
Slovenian: Marixino je „generično zdravilo“.
English: This is a summary of the European public assessment report (EPAR) for Marixino.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Marixino.
English: The Committee recommended that Marixino be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Marixino odobri za uporabo v EU.
English: What are the benefits and risks of Marixino?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Marixino?
English: This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
English: ‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Slovenian: „Biološko enakovredni“ pomeni, da naj bi zdravili dosegali enake ravni zdravilne učinkovine v telesu.
English: Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Slovenian: Zdravilo Marixino je na voljo v obliki 10- in 20-miligramskih tablet in se izdaja le na recept.
English: The company provided data on the medicine's solubility, composition and absorption in the body.
Slovenian: Družba je predstavila podatke o topnosti in sestavi zdravila ter njegovi absorpciji v telesu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Marixino, veljavno po vsej Evropski uniji, odobrila dne 29. aprila 2013.
English: Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Marixino generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.
Slovenian: Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Marixino.
English: It is not intended to provide practical advice on how to use Marixino.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Other information about Marixino
Slovenian: Druge informacije o zdravilu Marixino
English: It contains the active substance memantine hydrochloride.
Slovenian: Vsebuje zdravilno učinkovino memantinijev klorid.
English: What is Marixino and what is it used for?
Slovenian: Kaj je zdravilo Marixino in za kaj se uporablja?
English: No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa.
Slovenian: Potrebne niso bile nobene dodatne študije na bolnikih, saj je bilo dokazano, da ima zdravilo Marixino primerljivo raven kakovosti, in se šteje, da je biološko enakovredno referenčnemu zdravilu Ebixa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Marixino primerljivo raven kakovosti kot zdravilo Ebixa ter da mu je biološko enakovredno.
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Slovenian: Spremenjen način tega, kako glutamat prenaša signale v možganih, je povezan z izgubo spomina, kakršno je opaziti pri Alzheimerjevi bolezni.
English: For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Marixino preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Marixino approved?
Slovenian: Zakaj je bilo zdravilo Marixino odobreno?
English: For practical information about using Marixino, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Marixino naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Marixino so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The active substance in Marixino, memantine, is an antidementia medicine.
Slovenian: Zdravilna učinkovina zdravila Marixino, memantin, je zdravilo za zdravljenje demence.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing
Slovenian: oceniti v treh mesecih od začetka zdravljenja, od takrat naprej pa je treba redno ocenjevati koristi zdravljenja z zdravilom Marixino.
English: How does Marixino work?
Slovenian: Kako zdravilo Marixino deluje?
English: How has Marixino been studied?
Slovenian: Kako je bilo zdravilo Marixino raziskano?
English: How is Marixino used?
Slovenian: Kako se zdravilo Marixino uporablja?
English: The company requested a re-examination of the opinion.
Slovenian: Predlagatelj je zahteval ponovno presojo mnenja.
English: How does the medicine work?
Slovenian: Kako zdravilo deluje?
English: What was the medicine expected to be used for?
Slovenian: Za kaj naj bi se zdravilo uporabljalo?
English: At the time of the initial review, the CHMP had a number of concerns.
Slovenian: Odbor CHMP je že ob prvotnem pregledu imel številne pomisleke.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Slovenian: Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 14. septembra 2017 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
English: Secondly, at that time, there appeared to be an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care.
Slovenian: Drugič, takrat se je pri bolnikih, ki so jemali zdravilo, pojavilo večje tveganje za okužbo, ki ni ocenjeno kot sprejemljivo pri občutljivih bolnikih, ki bodo prejemali paliativno oskrbo.
English: Firstly, the study did not show clear improvements in either lean body mass or quality of life.
Slovenian: Prvič, študija ni pokazala jasnega izboljšanja puste telesne mase in kakovosti življenja.
English: The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.
Slovenian: Družba je obvestila odbor CHMP, da bo še naprej zagotavljala zdravila za vse bolnike, ki so trenutno vključeni v klinična preskušanja ali programe sočutne uporabe.
English: It was to be available as a concentrate to be made up into a solution for infusion.
Slovenian: Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje.
English: However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine's benefits and manufacturing controls.
Slovenian: Vendar ni na voljo dovolj podatkov o varnosti zdravila, da bi lahko ustrezno ocenili njegova skupna tveganja, zato je odbor še vedno imel pomisleke o njegovih koristih in kontrolah pri njegovi proizvodnji.
English: During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine.
Slovenian: Med ponovnim pregledom so odboru zagotovili, da noben neželeni učinek, o katerem so občasno poročali, ni bil neposredno povezan s tem zdravilom.
English: Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Slovenian: Ne nazadnje niso bile opravljene ustrezne kontrole proizvodnega postopka, ki bi zagotovile, da bo zdravilo imelo enako kakovost kot zdravilo, ki se je uporabilo v kliničnih preskušanjih.
English: The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life.
Slovenian: Družba je predstavila rezultate glavne študije pri 333 bolnikih o učinkih zdravila na pusto telesno maso (telesno maso brez maščob) in kakovost življenja.
English: Such symptoms include cachexia, a form of muscle wasting with significant weight loss.
Slovenian: Ti simptomi vključujejo kaheksijo, tj. obliko izgube mišic z znatno izgubo telesne mase.
English: The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine).
Slovenian: Zdravilo naj bi se uporabljajo za zdravljenje izčrpavajočih simptomov napredovalega kolorektalnega raka (raka debelega črevesa).
English: The medicine was compared with placebo (a dummy treatment).
Slovenian: Zdravilo so primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: Zato je še vedno vztrajal pri svojem mnenju, da koristi zdravila ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z njim zavrne.
English: By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Slovenian: Zdravilo zavira delovanje humanega interlevkina-1 alfa, zato naj bi upočasnilo rast raka ter lajšalo simptome pri bolnikih.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 18. maja 2017 priporočil zavrnitev vloge za pridobitev dovoljenja za promet s humanim monoklonskim protitelesom IgG1, specifičnim za humani interlevkin-1 alfa XBiotech, namenjenim zdravljenju izčrpavajočih simptomov napredovalega raka debelega črevesa.
English: The company that applied for authorisation is XBiotech Germany GmbH.
Slovenian: Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba XBiotech Germany GmbH.
English: growth and spread of cancer cells.
Slovenian: dejavnostih v telesu, vključno s pospeševanjem rasti in širjenjem rakavih celic.
English: What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
Slovenian: Kaj je zdravilo humano monoklonsko protitelo IgG1, specifično za humani interlevkin1 alfa XBiotech?
English: This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
Slovenian: To je zdravilo, ki vsebuje zdravilno učinkovino humano monoklonsko protitelo IgG1, specifično za humani interlevkin-1 alfa.
English: The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the
Slovenian: Zdravilna učinkovina je beljakovina, ki se veže na drugo beljakovino, imenovano humani interlevkin-1 alfa, in zavira njeno delovanje.
English: Tablets can be given either directly into the mouth or with food.
Slovenian: Tablete lahko daste neposredno v gobec ali s hrano.
English: There was no clinical effect.
Slovenian: Kliničnega učinka ni bilo.
English: Over 80% of male dogs above 5 years of age are affected.
Slovenian: Prizadene več kot 80% psov samcev nad 5 letom starosti.
English: No adverse effects on semen quality have been observed.
Slovenian: Škodljivi vplivi na kakovost semena niso bili opaženi.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik tega dovoljenja za promet mora obvestiti Evropsko komisijo o načrtih za trženje zdravila, ki ga dovoljuje ta odločitev.
English: REGARD TO SAFE AND EFFECTIVE USE
Slovenian: VARNE IN UČINKOVITE UPORABE
English: This binding is reversible and not affected by other substances known to specifically bind to albumin.
Slovenian: Vezava je reverzibilna in nanjo ne vplivajo druge snovi, za katere je znano, da se specifično vežejo na albumin.
English: 1 tablet
Slovenian: 1 tablete
English: If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Slovenian: Če je klinični odgovor na zdravljenje znatno krajši od pričakovanega, je treba ponovno oceniti postavljeno diagnozo.
English: Dog's weight
Slovenian: Teža psa
English: The maximum dose should not be exceeded.
Slovenian: Največjega odmerka ne smete preseči.
English: ATC vet code : QG04C X
Slovenian: oznaka ATC vet: QG04C X
English: This veterinary medicinal product does not require any special storage conditions.
Slovenian: To zdravilo ne potrebuje nobenih posebnih pogojev za shranjevanje.
English: This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
Slovenian: To lahko privede do več nespecifičnih kliničnih znakov, kot so bolečina v trebuhu, težave pri iztrebljanju in uriniranju, kri v urinu in motnje gibanja.
English: Elimination is slow with a mean half-life (T½) of about 80 hours.
Slovenian: Izločanje je počasno s srednjim razpolovnim časom (T½) okoli 80 ur.
English: It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate.
Slovenian: Kompetitivno preprečuje vezavo androgenov na njihove prostatične receptorje in blokira prenos testosterona v prostato.
English: *No data are available for dogs less than 3 kg bodyweight
Slovenian: *Za pse lažje od 3 kilogramov ni podatkov.
English: In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Slovenian: V kliničnih preizkusih zdravljenje s tem zdravilom ni bilo prekinjeno, vsi psi pa so okrevali brez posebne terapije.
English: Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l.
Slovenian: Petnajst dni po zadnjem odmerku je srednja plazemska koncentracija okoli 6,5 µg/l.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Natančne informacije o tem izdelku veterinarske medicine so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: Dogs (male)
Slovenian: Psi (samci)
English: Osaterone acetate
Slovenian: Osateronijev acetat
English: 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.
Slovenian: Študija prevelikega odmerjanja (do 1,25 mg/kg telesne teže za 10 dni s ponovitvijo čez en mesec) ni pokazala neželenih učinkov razen znižanja koncentracije plazemskega kortizola.
English: Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine.
Slovenian: Osateron se izloči v 14 dneh v glavnem skozi blato preko izločanja žolča (60%) in v manjši meri (25%) preko urina.
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
Slovenian: DODATEK II A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE D. NAVEDBA NAJVIŠJIH DOVOLJENIH ZAOSTANKOV ZDRAVILA (MRL)
English: Wash hands after administration.
Slovenian: Po dajanju zdravila si umijte roke.
English: Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
Slovenian: Tablete Okrogla, bela, bikonveksna tablete velikosti 5,5 mm, 7 mm, 9 mm in 12 mm.
English: REGARDING SUPPLY OR USE
Slovenian: OSKRBE IN UPORABE
English: Do not use after the expiry date stated on the blister after “EXP”
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za "EXP"
English: PHARMACEUTICAL FORM Tablet.
Slovenian: FARMACEVTSKA OBLIKA Tablete.
English: 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.
Slovenian: Prehodni stranski učinki v spremembi dlake, kot so izguba ali sprememba dlake so bili po uporabi Ypozane opaženi le zelo redko.
English: Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur.
Slovenian: Veterinar naj naredi ponovno oceno 5 mesecev po zdravljenju ali prej, če se klinični znaki ponovijo.
English: Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin.
Slovenian: Osateronijev acetat in njegov metabolit sta vezana na plazemske proteine (prvi okoli 90% in slednji okoli 80%) v glavnem na albumin.
English: PACKAGE SIZE 7 tablets.
Slovenian: VELIKOST PAKIRANJA 7 tablet.
English: Benign prostatic hypertrophy (BPH) is a natural consequence of ageing.
Slovenian: Benigna hipertrofija prostate (BHP) je naravna posledica staranja.
English: 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.
Slovenian: Po ponovljenem odmerjanju osateronijevega acetata z 0,25 mg/kg/dan za 7 dni je akumulacijski faktor okoli 3-4 brez spremembe v hitrosti absorpcije ali izločanja.
English: The clinical response persists for at least 5 months after treatment.
Slovenian: Klinični odgovor traja vsaj 5 mesecev po zdravljenju.
English: Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms.
Slovenian: Osateronijev acetat inhibira učinke presežka moškega hormona (testosterona) preko več mehanizmov.