FrancophonIA/ELRC3.0 huggingface dataset:
English: Methylthioninium chloride Proveblue is an in vitro inhibitor of P-gp.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue je in vitro zaviralec P-gp.
English: You should not be given this medicine after the expiry date which is printed on the carton and the ampoule labels after EXP.
Slovenian: Tega zdravila ne smete uporabiti po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in nalepkah na ampulah poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: How to store Methylthioninium chloride Proveblue
Slovenian: Kako uporabljati zdravilo Metiltioninijev klorid Proveblue
English: No evidence of carcinogenic activity was observed in female rats.
Slovenian: Pri samicah podgan ni bilo opaziti dokazov kancerogene aktivnosti.
English: Methylthioninium chloride is a potent inhibitor of the transporters OCT2, MATE1 and MATE2-K.
Slovenian: Metiltioninijev klorid je močan zaviralec prenašalcev OCT2, MATE1 in MATE2-K. Klinične posledice zaviranja niso znane.
English: Musculoskeletal and connective tissue disorder
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v udu zelo pogosti
English: PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, France
Slovenian: Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, Francija
English: Provepharm SAS 22 rue Marc Donadille, 13013 Marseille, France
Slovenian: PROVEPHARM SAS 22 rue Marc Donadille, 13013 Marseille, Francija
English: The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.
Slovenian: Priporočeni odmerek je 0,3 do 0,5 mg/kg telesne mase, tj. 0,06 do 0,1 ml/kg telesne mase, čas trajanja injiciranja pa 5 minut.
English: The usual dose is 1 to 2 mg per kg body weight, i.e. 0.2-0.4 ml per kg body weight, given over a period of 5 minutes.
Slovenian: Običajni odmerek je 1 do 2 mg na kg telesne mase, tj. 0,2-0,4 ml na kg telesne mase, čas trajanja injiciranja pa 5 minut.
English: Its use in parathyroid surgery (not indicated) has induced adverse CNS effects when administered concomitantly with serotonergic medicinal products (see section 4.5).
Slovenian: Njegova sočasna uporaba s serotogeničnimi zdravili pri operaciji obščitnične žleze (za kar zdravilo ni indicirano) je povzročila neželene učinke na osrednjem živčevju (glejte poglavje 4.5).
English: After intravenous administration Methylthioninium chloride Proveblue is rapidly taken up by the tissues.
Slovenian: Po intravenski aplikaciji tkiva hitro absorbirajo zdravilo Metiltioninijev klorid Proveblue.
English: Methylthioninium chloride Proveblue has been observed to stain tissues selectively.
Slovenian: Opaženo je bilo, da zdravilo Metiltioninijev klorid Proveblue selektivno obarva tkiva.
English: Methylthioninium chloride Proveblue is hypotonic and may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue je hipotonično in se ga lahko razredči v 50 ml glukoze 50 mg/ml (5 %) raztopina za injiciranje, da se izognemo lokalni bolečini, zlasti pri pediatrični populaciji.
English: Each box contains a tray with 5 ampoules of 2 ml.
Slovenian: Ena škatla vsebuje podstavek s 5 ampulami po 2 ml.
English: Each box contains a tray with 5 ampoules of 10 ml.
Slovenian: Ena škatla vsebuje podstavek s 5 ampulami po 10 ml.
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Slovenian: Ena 10 ml ampula vsebuje 50 mg metiltioninijevega klorida.
English: Methylthioninium chloride Proveblue is for administration by a healthcare professional.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue sme dati samo zdravstveni delavec.
English: Each 2 ml ampoule contains 10 mg methylthioninium chloride.
Slovenian: Ena 2 ml ampula vsebuje 10 mg metiltioninijevega klorida.
English: Each ml of solution contains 5 mg methylthioninium chloride.
Slovenian: En ml raztopine vsebuje 5 mg metiltioninijevega klorida.
English: Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Slovenian: Zdravilo Metiltioninijev klorid Proveblue se lahko razredči v 50 ml raztopine glukoze 50 mg/ml (5 %) za injiciranje, da se izognemo lokalni bolečini, zlasti pri pediatrični populaciji.
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Slovenian: Metiltioninijev klorid Proveblue 5 mg/ml raztopina za injiciranje
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaktične reakcije neznana
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection Methylthioninium chloride
Slovenian: Metiltioninijev klorid Proveblue 5 mg/ml raztopina za injiciranje metiltioninijev klorid
English: Methylthioninium chloride Proveblue 5 mg/ml injection methylthioninium chloride
Slovenian: Metiltioninijev klorid Proveblue 5 mg/ml injekcija metiltioninijev klorid
English: Local tissue necrosis at the injection site Not known Injection site pain
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečine v prsih pogosti nekroza lokalnega tkiva na mestu aplikacije neznana bolečina na mestu injiciranja pogosti
English: Intravenous use only
Slovenian: Samo za intravensko uporabo.
English: Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.
Slovenian: Ena škatla vsebuje podstavek s 5 ampulami po 10 ml. Ena škatla vsebuje podstavek s 5 ali 20 ampulami po 2 ml. Na trgu morda ni vseh navedenih pakiranj.
English: Dyspnoea
Slovenian: AMPULA
English: Monitoring tests You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.
Slovenian: Med zdravljenjem z zdravilom Metiltioninijev klorid Proveblue in po njem boste opravili kontrolne teste.
English: The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes.
Slovenian: Odrasli, otroci, starejši od 3 mesecev, in starejše osebe Običajni odmerek je 1 do 2 mg na kilogram telesne mase, tj. 0,2 do 0,4 ml na kilogram telesne mase, čas trajanja injiciranja pa 5 minut.
English: Gastrointestinal disorders
Slovenian: Testi za spremljanje
English: Serotonin Syndrome with concomitant use of serotonergic drugs (see section 4.4 and section 4.5).
Slovenian: Bolezni živčevja omotica zelo pogosti glavobol pogosti tesnoba pogosti tremor neznano zvišana telesna temperatura neznano afazija neznano parestezija zelo pogosti disgevzija zelo pogosti serotoninski sindrom pri sočasni uporabi serotonergičnih zdravil (glejte poglavje 4.4 in poglavje 4.5)
English: It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia.
Slovenian: Pri bolnikih z methemoglobinemijo, povzročeno z dapsonom, se priporoča, da se ne preseže kumulativnega odmerka celotnega zdravljenja 4 mg/kg.
English: The responses were submitted on 25 November 2003.
Slovenian: Odgovori so bili predloženi 25. novembra 2003.
English: B-1070 Bruxelles Belgium
Slovenian: B-1070 Bruxelles Belgija
English: I-20090 Assago (MI) Italy
Slovenian: I-20090 Assago (MI) Italija
English: Conclusions and recommendations
Slovenian: Sklepi in priporočila
English: E-08014 Barcelona Spain
Slovenian: E-08014 Barcelona Španija
English: 2.1 Residue depletion studies
Slovenian: 2.1 Raziskave izginevanja ostankov
English: 29 av Tony Garnier F-69007 Lyon France
Slovenian: 29 av Tony Garnier F-69007 Lyon Francija
English: For the 4th study, the statistical method could not be used due to large variation in the data set.
Slovenian: Za četrto raziskavo statistične metode ni bilo moč uporabiti zaradi velike variacije podatkov.
English: AMSTELVEEN The Netherlands
Slovenian: AMSTELVEEN Nizozemska
English: For 3 studies the data allowed the use of the statistical approach.
Slovenian: Prve tri raziskave so omogočile uporabo statističnega pristopa.
English: Muscle: 50 µg/kg Fat: 250 µg/kg Liver: 1500 µg/kg Kidney: 300 µg/kg Milk: 20 µg/kg
Slovenian: Mišica: 50 µg/kg Maščoba: 250 µg/kg Jetra: 1500 µg/kg Ledvice: 300 µg/kg Mleko: 20 µg/kg
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 28 July 2003.
Slovenian: Vprašanja, ki so se nanašala na obdobja karence, so bila predložena imetnikom dovoljenj za promet 28. julija 2003.
English: Box 327
Slovenian: P.O. Box 327
English: All studies were conducted according to GLP-guidelines and using the formulation as marketed in all relevant Member States and Norway in the correct dosage.
Slovenian: Vse raziskave so bile izvedene skladno s smernicami GLP in so vključevale farmacevtske oblike, ki se tržijo v vseh zadevnih državah članicah in na Norveškem v ustreznih odmerkih.
English: UK-Essex CM19 5TG United Kingdom
Slovenian: UK-Essex CM19 5TG Velika Britanija
English: Residue concentrations in this study showed a large variation.
Slovenian: Koncentracije zaostankov v tej študiji so bile zelo spremenljive.
English: The withdrawal period was calculated using either the statistical approach or the alternative approach, as appropriate according to the CVMP note for guidance approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Slovenian: Karenca je bila izračunana ali s statističnim ali z alternativnim pristopom skladno z opombo CVMP za usmerjen pristop k usklajevanju karenčnih obdobij (EMEA/CVMP/036/95).
English: Eprinomectin was included in Annex I of Council Regulation 2377/90 and the following maximum residue limits were established for bovine species:
Slovenian: Eprinomektin je bil vključen v Dodatek I Uredbe Sveta 2377/90, kjer so bile določene naslednje najvišje mejne vrednosti zaostankov v govedu:
English: The withdrawal periods set for edible tissues by the different Member States diverge significantly, from 0 to 21 days.
Slovenian: Karenca za užitna tkiva se med državami članicami znatno razlikuje, in sicer od 0 do 21 dni.
English: However, this is not considered as causing difficulties to establish an appropriate withdrawal period.
Slovenian: Vendar to ne ovira določanja ustreznih obdobij karence.
English: The withdrawal period for milk of zero days as established in all the relevant Member States and Norway is unaffected.
Slovenian: To ne vpliva na karenco za mleko 0 dni, ki je uveljavljena v vseh državah članicah in na Norveškem.
English: Based on the results of the four different residue depletion studies conducted in adult cattle as well in calves, the longest calculated withdrawal period in meat and offal is 15 days (by statistical approach) or 14 days plus a safety margin (by alternative approach).
Slovenian: Na podlagi rezultatov štirih različnih raziskav izginevanja zaostankov, ki so bile izvedene pri odraslem govedu in teletih, je najdaljša izračunana karenca za meso in drobovino 15 dni (s statističnim pristopom) oz. 14 dni z varnostnim odmikom (z alternativnim pristopom).
English: Eprinex pour-on products contain eprinomectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle including lactating cows.
Slovenian: Eprinex kožni polivi (pour on) vsebujejo eprinomektin, ki je polsintetična spojina iz skupine avermektinov in so namenjeni zdravljenju notranjih in zunanjih parazitoz pri govedu in kravah v obdobju laktacije.
English: Tissue residue concentrations exceeded the MRL after 1 day (in fat and muscle) and after 7 days (in liver, fat and muscle) but were below the MRL at 14 days post treatment.
Slovenian: Koncentracije zaostankov v tkivih so presegle vrednosti MRL po 1 dnevu (v maščobi in mišici) in po 7 dneh (v jetrih, maščobi in mišici), vendar so padle pod MRL po 14. dnevu od zdravljenja.
English: The product has been authorised in the European Union (all Member States except Greece) and in Norway as a pour on solution for topical use.
Slovenian: Izdelek je bil v Evropski uniji (v vseh državah članicah, razen v Grčiji) in na
English: Strength Pharmaceutical form Route of administration Animal species
Slovenian: Farmacevtska oblika Način dajanja zdravila Vrsta živali
English: Therefore, the CVMP recommended that all marketing authorisations pour-on solutions containing eprinomectin for topical use in bovine species known as Eprinex or variations of that name as referred to in Annex I a withdrawal period for meat and offal of 15 days is set.
Slovenian: Zato CVMP priporoča, da se za vsa dovoljenja za promet kožnih polivov, ki vsebujejo eprinomektin za topikalno uporabo pri vrstah goveda, imenovanih Eprinex oz. variacijami imen, ki so navedene v Dodatku I, določi Karenca za meso in drobovino 15 dni.
English: Solution for external use Topical
Slovenian: Raztopina za zunanjo uporabo
English: Tissue residue concentrations were highest after 3 days and declined afterwards and did not exceeded the MRL at any time point.
Slovenian: Koncentracije zaostankov v tkivih so bile najvišje po 3 dneh, nato pa so padale in nikoli niso presegle vrednosti MRL.
English: In all studies, only perirenal fat was sampled and the residue concentration in dose site fat was not investigated.
Slovenian: V vseh raziskavah so bili odvzeti vzorci maščobe le perirenalno, maščoba na mestu nanosa odmerka pa ni bila preiskana za ostanke.
English: Two untreated control animals were slaughtered two days before treatment.
Slovenian: Dve nezdravljeni kontrolni živali sta bili zaklani dva dni pred zdravljenjem.
English: This approach yields 7 days plus a safety margin for the 1st study, 10 days plus a safety margin for the 2nd study, and 0.5 days plus a safety margin for the 3rd.
Slovenian: Ta pristop da karenco 7 dni z varnostnim odmikom za prvo raziskavo, 10 dni z varnostnim odmikom za drugo raziskavo in 0,5 dneva z varnostnim odmikom za četrto raziskavo.
English: Residues were below the MRL values at all points measured.
Slovenian: Zaostanki so bili pod vrednostmi MRL na vseh merjenih točkah.
English: Member State
Slovenian: DRŽAVAH ČLANICAH
English: 2.2 Calculation of withdrawal periods
Slovenian: 2.2 Izračun obdobij karence
English: All four studies were considered relevant to be used in the establishment for the determination of the withdrawal period.
Slovenian: Za vse štiri študije je bilo ugotovljeno, da so primerne za določevanje karence.
English: One untreated control animal was slaughtered just before treatment and another one after 14 days.
Slovenian: Ena nezdravljena kontrolna žival je bila zaklana tik pred izvedbo zdravljenja, druga pa po 14 dneh.
English: Tissue samples were taken from the muscle, perirenal fat, liver, kidney and dose-site muscle.
Slovenian: Vzorci tkiv so bili odvzeti iz mišice, perirenalne maščobe, jeter, ledvic in mišice na mestu nanosa.
English: For the referral procedure one radiolabelled and three non-radiolabelled residue depletion studies in cattle were submitted.
Slovenian: V posvetovalnem postopku so bile predložene raziskave izločanja zaostankov pri govedu, in sicer ena z radioaktivnimi označevalci in tri z neradioaktivnimi označevalci.
English: Two untreated control animals were slaughtered the day before treatment and 2 others 23 days after treatment.
Slovenian: Dve nezdravljeni kontrolni živali sta bili zaklani en dan pred zdravljenjem, dve drugi kontrolni živali pa 23 dni po zdravljenju.
English: Residue concentrations were below the MRL values at all points measured.
Slovenian: Koncentracije zaostankov so bile pod vrednostmi MRL na vseh merjenih točkah.
English: The CVMP had previously assessed eprinomectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Slovenian: CVMP je predhodno, skladno z Uredbo Sveta 2377/90, že ovrednotila eprinomektin glede določitve najvišjih mejnih vrednosti zaostankov zdravil (maximum residue limits, MRL).
English: The CVMP during its meeting of 23 July 2003 decided to start a referral procedure under Article 34 of Council Directive 2001/82/EC for the Eprinex pour-on products containing eprinomectin.
Slovenian: CVMP se je na sestanku 23. julija 2003 odločila, da začne posvetovalni postopek po 34. členu
English: However animals were only slaughtered at withdrawal times of 10 days or more, therefore, it could not be excluded that the MRL was not exceeded at earlier time points.
Slovenian: Ker so bile živali zaklane 10 ali več dni po preteku karenčnga obdobja, ni možno izključiti, da vrednosti MRL niso bile presežene v neki časovni točki pred zakolom.
English: Animals were slaughtered on day 10, 17, 24, 34, 44 and 55 after treatment, 5 animals per time point.
Slovenian: Zakol je bil opravljen 10., 17., 24., 34., 44. in 55. dan po zdravljenju, vsakič po pet živali.
English: However, animals were only slaughtered at withdrawal times of 7 days or more, therefore, it could not be excluded that the MRL was not exceeded at earlier time points.
Slovenian: Ker so bile živali zaklane 7 ali več dni po preteku karenčnega obdobja, ni možno izključiti, da vrednosti MRL niso bile presežene v neki časovni točki pred zakolom.
English: United Kingdom Merial Ltd Sandringham House Harlow Business Park Harlow
Slovenian: Velika Britanija Merial Ltd Sandringham House Harlow Business Park Harlow
English: The withdrawal period for milk was consistently set as 0 days.
Slovenian: Karenca za mleko je povsod 0 dni.
English: The Netherlands Merial BV Bovenkerkerweg 6-8
Slovenian: Merial BV Bovenkerkerweg 6-8 1185 XE
English: Merial GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany
Slovenian: D-85399 Hallbergmoos
English: The withdrawal period calculated was 15 days for 2 of the studies and 3 days for the 3rd one, based on depletion from liver.
Slovenian: Karenca je bila izračunana na podlagi izločanja zazaostankov iz jeter, in sicer za prvi dve raziskavi 15 dni, za tretjo raziskavo pa 3 dni.
English: Animals were slaughtered at 0.5, 1, 3, 5 and 7 days after treatment, 5 animals per time point.
Slovenian: Zakol je bil opravljen 0.5., 1., 3., 5. in 7. dan po zdravljenju, vsakič po pet živali.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, NAČINOV DAJANJA,
English: In the radiolabelled study 14 steers and heifers, aged 8-10 months were administered topically [5-3]Hradiolabelled eprinomectin at a single dose of 0.5 mg/kg bw.
Slovenian: V raziskavi z radioaktivnimi označevalci je bil [5-3]H-radioaktivno označen eprinomektin topikalno nanešen pri 14 kastratih in telicah, starih 8-10 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
English: Overall, a withdrawal period of 15 days is considered appropriate to ensure depletion of residues below the MRLs.
Slovenian: Končni sklep je, da je karenca 15 dni primerna za zmanjšanje koncentracij zazaostankov pod vrednosti
English: On 18 June 2003 Germany requested the CVMP to give an opinion under Article 34 of Council Directive 2001/82/EC concerning the divergent decisions taken by the competent national authorities regarding the withdrawal periods for meat and offal when granting the marketing authorisations for Eprinex pour on products.
Slovenian: Veterinary Medicinal Products - Odbor ) za mnenje glede različnih odločitev pristojnih nacionalnih organov o obdobju karence za meso in drobovino v postopkih podeljevanja dovoljenj za promet za kožne polive Eprinex.
English: The CVMP established a toxicological ADI of 5 µg/kg bw (300 µg/person) for eprinomectin, based on the NOEL of 1.0 mg/kg bw/day for mydriasis and focal neuronal degeneration of the nervous system observed in the 53-week toxicity study in beagle dogs and applying a safety factor of 200.
Slovenian: NOEL 1,0 mg/kg telesne mase za midriazo in degeneracijo nevronskih žarišč v živčevju (določene v
English: Marker residue concentrations were determined using validated HPLC-fluorescence method with a limit of detection of 1 µg/kg and limit of quantification of 2 µg/kg.
Slovenian: Koncentracije ostankov označevalca so bile določene z validirano HPLC-fluorescenčno metodo, ki je imela mejo zaznavnosti 1 µg/kg in mejo določljivosti 2 µg/kg.
English: In the third non-radiolabelled study 12 male non-ruminating calves, aged 11 to 13 weeks, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
Slovenian: V tretji raziskavi z neradioaktivnimi označevalci je bil eprinomektin topikalno nanešen pri 12 sesnih teletih, starih od 11 do 13 tednov, v enkratnem odmerku 0,5 mg/kg telesne mase.
English: Animals were slaughtered at 7, 14, 21 and 28 days after treatment, 3 animals per time point.
Slovenian: Zakol je bil opravljen 7., 14., 21. in 28. dan po zdravljenju, vsakič po tri živali.
English: The alternative approach yields a withdrawal period of 14 days plus a safety margin, based on depletion from liver, fat and muscle for the 4th study.
Slovenian: Z alternativnim pristopom je bilo na podlagi izločanja zazaostankov iz jeter, maščobe in mišice v četrti raziskavi izračunano karenco 14 dni z varnostnim odmikom.
English: Plasma and residue levels were higher in non-ruminant calves than in adult cattle and it took longer to reach a maximum level; tissue residue concentrations were highest after 7 days.
Slovenian: Pri sesnih teletih je trajalo dlje, da so koncentracije dosegle najvišjo raven, saj so bile koncentracije zaostankov v tkivih najvišje po 7 dneh.
English: Residue concentrations in dose-site muscle showed a large variation, the highest concentration was found in a 28-day sample, the latest time point in the study and residue concentrations were higher than in muscle (by a factor of about 3-4).
Slovenian: Najvišja koncentracija je bila ugotovljena v vzorcu 28. dne (zadnji časovni točki v raziskavi)
English: Cattle and dairy cows
Slovenian: Govedo in molzne krave
English: P.O.
Slovenian: MRL.
English: In a non-radiolabelled study 17 male castrate and 17 female beef cattle, aged 17 to 20 months, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
Slovenian: 17 pitankah, starih od 17 do 20 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
English: Lactating and non-lactating cattle
Slovenian: Govedo v laktaciji in govedo izven laktacije
English: Cattle including lactating cows
Slovenian: Pitano govedo, molzne krave vključno s kravami v laktaciji
English: In a second non-radiolabelled study 14 male castrate and 13 female cattle, aged 12-19 months, were administered topically eprinomectin at a single dose of 0.5 mg/kg bw.
Slovenian: kastratih in 13 telicah, starih 12-19 mesecev, v enkratnem odmerku 0,5 mg/kg telesne mase.
English: Animals were slaughtered on day 1, 3, 7 and 14 after treatment, 3 animals per time point.
Slovenian: 1., 3., 7. in 14. dan po izvedenem zdravljenju, vsakič s po tremi živalmi.
English: Beef and dairy cattle including lactating dairy cattle
Slovenian: Pitano in molzno govedo vključujoč molzno govedo v času laktacije
English: Date of first authorisation: 20 July 2015
Slovenian: Datum prve odobritve: 20. julij 2015
English: CI=Confidence Interval
Slovenian: CI=interval zaupanja
English: Overall survival*
Slovenian: Celokupno preživetje*
English: Each pack contains 1 vial.
Slovenian: Ena škatla vsebuje eno vialo.
English: Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
English: 1-year Overall Survival (%)e
Slovenian: 1-letno celokupno preživetje (%)e
English: You may experience a reduction in the number of:
Slovenian: Lahko boste imeli zmanjšanje števila
English: Progression Free Survival, months
Slovenian: Preživetje brez napredovanja bolezni, meseci
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Slovenian: Končna analiza OS, ki so jo izvedli po mediani sledenja 8,6 let, ni pokazala nobene pomembne razlike v OS med obema skupinama zdravljenja.
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Slovenian: Preglednica 14: Povzetek izidov bolezni v preskušanjih faze III (APEX) in II faza III