FrancophonIA/ELRC3.0 huggingface dataset:
English: The cytochrome P450 enzymes CYP3A4, CYP2C8, CYP2C9, and CYP2C19 are involved in the metabolism of macitentan and formation of its metabolites (see section 5.2).
Slovenian: V presnovi macitentana in nastajanju njegovih presnovkov sodelujejo encimi citokroma P450, CYP3A4, CYP2C8, CYP2C9 in CYP2C19 (glejte poglavje 5.2).
English: In the presence of strong CYP3A4 inducers reduced efficacy of macitentan could occur.
Slovenian: V prisotnosti močnega induktorja CYP3A4, kot je rifampicin, je treba upoštevati zmanjšano učinkovitost macitentana.
English: Macitentan induced minimal to slight mucosal hyperplasia and inflammatory infiltration in the submucosa of the nasal cavity in the mouse carcinogenicity study at all doses.
Slovenian: Macitentan je pri vseh odmerkih v študijah kancerogenosti pri miših induciral minimalno do blago hiperplazijo sluznice in vnetno infiltracijo v podsluznico nosne votline.
English: No nasal cavity findings were noted in the 3-month mouse toxicity study or in rat and dog studies.
Slovenian: V 3-mesečni študiji toksičnosti pri miših ali v študijah pri podganah in psih niso prišli do izsledkov v nosni votlini.
English: Based on PK data, no dose adjustment is required in patients with renal impairment.
Slovenian: Ledvična okvara Na podlagi FK podatkov prilagoditev odmerka pri bolnikih z ledvično okvaro ni potrebna.
English: You need to use a reliable form of birth control (contraception) while you are taking Opsumit.
Slovenian: Med jemanjem tega zdravila morate uporabljati učinkovit način preprečevanja nosečnosti (kontracepcijo).
English: Evaluation of 6MWD by functional class resulted in a placebo-corrected mean increase from baseline to Month 6 in FC III/IV patients of 37 meters (97.5% CI: 5 to 69) and in FC I/II of 12 meters (97.5% CI: −8 to 33).
Slovenian: Ocena 6MWD glede na funkcionalni razred je pokazala za placebo popravljeno povprečno zvišanje od izhodišča do 6. meseca za 37 metrov (97,5 % IZ: 5 do 69) pri bolnikih iz FR III/IV in za 12 metrov (97,5 % IZ: -8 do 33) pri bolnikih iz FR I/II.
English: In a long-term doubleblind study in patients with PAH, hypotension was reported for 7.0% and 4.4% of patients on macitentan 10 mg and placebo, respectively.
Slovenian: V dolgoročni, dvojno slepi študiji pri bolnikih s PAH so o hipotenziji poročali pri 7,0 % bolnikih, ki so prejemali macitentan 10 mg, in pri 4,4 % bolnikih, ki so prejemali placebo.
English: • The need for regular blood tests because Opsumit causes a decrease in haemoglobin;
Slovenian: • da je treba redno izvajati krvne preiskave, saj zdravilo Opsumit povzroča znižanje ravni hemoglobina; • da je treba redno spremljati delovanje jeter, saj je lahko zdravilo Opsumit hepatotoksično.
English: Treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity-mortality endpoint up to EOT when compared to placebo [Figure 1 and Table 1].
Slovenian: Zdravljenje z macitentanom 10 mg je povzročilo 45 % zmanjšanje tveganja (razmerje tveganja [HR, hazard ratio] 0,55; 97,5-odstotni IZ 0,39 do 0,76; logrank vrednost p < 0,0001) za sestavljeni opazovani dogodek obolevnost-smrtnost do konca zdravljenja v primerjavi s placebom [Slika 1 in
English: Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.6).
Slovenian: Zdravljenje z zdravilom Opsumit se sme pri ženskah v rodni dobi uvesti samo, če je bila odsotnost nosečnosti potrjena, če je bilo ženski ustrezno svetovano glede uporabe kontracepcije in če uporablja učinkovito kontracepcijo (glejte poglavji 4.3 in 4.6).
English: Macitentan inhibits the breast cancer resistance protein (BCRP) at clinically relevant intestinal concentrations.
Slovenian: Macitentan v klinično koncentracijah v črevesju pomembnih zavira protein odpornosti na raka dojke (BCRP, breast cancer resistance protein).
English: In a double-blind study in patients with idiopathic pulmonary fibrosis, the incidence of peripheral oedema AEs in the macitentan and placebo treatment groups was 11.8% and 6.8%, respectively.
Slovenian: V dvojno slepi študiji pri bolnikih z idiopatsko pljučno fibrozo je bila incidenca neželenega učinka perifernega edema 11,8 % v skupini, zdravljeni z macitentanom, in 6,8 % v skupini, ki je dobivala placebo.
English: If you notice any of these signs, tell your doctor.
Slovenian: • bledico Če opazite katerega od teh znakov, obvestite zdravnika.
English: • Bronchitis (inflammation of the airways)
Slovenian: • bronhitis (vnetje dihalnih pot)
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a mean decrease in haemoglobin versus placebo of 1 g/dL.
Slovenian: V dvojno slepi študiji pri bolnikih s PAH je bila uporaba macitentana 10 mg povezana s povprečnim zmanjšanjem koncentracije hemoglobina v primerjavi s placebom 1 g/dl.
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean platelet count of 17 × 109/L, versus a mean decrease of 11 × 109/L in placebo-treated patients.
Slovenian: V dvojno slepi študiji pri bolnikih s PAH je bil macitentan 10 mg povezan z zmanjšanjem povprečnega števila trombocitov za 17 × 109/l v primerjavi z 11 × 109/l pri bolnikih, ki so dobivali placebo.
English: There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment.
Slovenian: Kliničnih izkušenj z uporabo macitentana pri bolnikih s PAH s hudo ledvično okvaro ni.
English: Consequently, if signs of pulmonary oedema occur when macitentan is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.
Slovenian: Posledično je treba pomisliti na možnost pljučne vensko-okluzivne bolezni, če se pojavijo znaki pljučnega edema pri bolnikih s PAH, ki dobivajo macitentan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/893/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON for BLISTERS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA za PRETISNE OMOTE
English: Strong CYP3A4 inducers: Concomitant treatment with rifampicin 600 mg daily, a potent inducer of CYP3A4, reduced the steady-state exposure to macitentan by 79% but did not affect the exposure to the active metabolite.
Slovenian: Močni induktorji CYP3A4: Sočasno zdravljenje z rifampicinom 600 mg na dan, močnim induktorjem CYP3A4, je zmanjšala izpostavljenost macitentanu v stanju dinamičnega ravnovesja za
English: Hypersensitivity reactions (e.g., angioedema, pruritus, rash)1
Slovenian: (npr. angioedem, pruritus,
English: The risk of PAH related death or hospitalisation for PAH up to EOT was reduced by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001) in patients receiving macitentan 10 mg (50 events) compared to placebo (84 events).
Slovenian: Tveganje smrti zaradi PAH ali hospitalizacije zaradi PAH do konca zdravljenja se je pri bolnikih, ki so prejemali macitentan 10 mg (50 dogodkov) v primerjavi s placebom (84 dogodkov), zmanjšalo za 50 % (HR 0,50; 97,5 % IZ: 0,34 do 0,75; logrank vrednost p < 0,0001).
English: Signs that your liver may not be working properly include: nausea (urge to vomit) vomiting fever (high temperature) pain in your stomach (abdomen) jaundice (yellowing of your skin or the whites of your eyes) dark-coloured urine itching of your skin lethargy or fatigue (unusual tiredness or exhaustion) flu-like syndrome (joint and muscle pain with fever)
Slovenian: temno obarvan urin srbenje kože letargijo ali utrujenost (neobičajno utrujenost ali izčrpanost) gripi podoben sindrom (bolečine sklepov in mišic z zvišano telesno temperaturo)
English: The pharmacodynamic effect of warfarin on International Normalised Ratio (INR) was not affected by macitentan.
Slovenian: Macitentan ni vplival na farmakodinamični učinek varfarina na mednarodno normalizirano razmerje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/893/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/893/003
English: No testicular findings were noted in mice after treatment up to 2 years.
Slovenian: Pri miših po dajanju macitentana, ki je trajalo do 2 leti, niso opazili sprememb na testisih.
English: • Urinary tract infection (bladder infection)
Slovenian: • okužba sečil (okužba mehurja)
English: 3 Oedema/fluid retention has been associated with the use of ERAs including macitentan.
Slovenian: 3 Z uporabo ERA, vključno z macitentanom povezujejo edem/zastajanje tekočine.
English: Use in women of childbearing potential/Contraception in males and females Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised (see sections 4.3 and 4.4).
Slovenian: Zdravljenje z zdravilom Opsumit se sme pri ženskah v rodni dobi uvesti samo, če je bila odsotnost nosečnosti potrjena, če je bilo ženski ustrezno svetovano glede uporabe kontracepcije in če uporablja učinkovito kontracepcijo (glejte poglavji 4.3 in 4.4).
English: The pharmacokinetics of macitentan in PAH patients were not influenced by the severity of the disease.
Slovenian: Resnost bolezni pri bolnikih s PAH ni vplivala na farmakokinetiko macitentana.
English: • Patient reminder cards.
Slovenian: • opozorilno kartico za bolnike.
English: Slightly increased pre- and post-implantation loss, decreased mean number of pups, and decreased testis and epididymis weights, were observed at exposures 7-fold the human exposure.
Slovenian: Pri izpostavljenosti, ki je bila 7-krat večja kot izpostavljenost pri ljudeh, so opazili rahlo povečanje pred- in poimplantacijske izgube zarodkov, zmanjšano povprečno število mladičev in zmanjšano maso mod in epididimisa.
English: In a placebo-controlled trial in patients with PAH, the efficacy and safety of macitentan in combination with sildenafil were demonstrated.
Slovenian: Učinkovitost in varnost macitentana v kombinaciji s sildenafilom pri bolnikih s PAH so dokazali v s placebom kontroliranem preskušanju.
English: See package leaflet for further information
Slovenian: Glejte navodilo za uporabo za več informacij.
English: • feeling sick (nausea)
Slovenian: • siljenje na bruhanje (navzeo) • bruhanje
English: • flu-like syndrome (joint and muscle pain with fever)
Slovenian: • neobičajno utrujenost ali izčrpanost (letargijo ali utrujenost) • gripi podoben sindrom (bolečine sklepov in mišic z zvišano telesno temperaturo)
English: Talk to your doctor or pharmacist before taking Opsumit.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Opsumit se posvetujte z zdravnikom ali farmacevtom.
English: Swallow the whole tablet, with a glass of water, do not chew or break the tablet.
Slovenian: Priporočeni odmerek zdravila Opsumit je ena 10 mg tableta enkrat na dan. Tableto zaužijte celo s kozarcem vode in je ne žvečite ali lomite.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI NA TRAKU
English: Do not use Opsumit after the expiry date which is stated on the carton, bottle and blister after “EXP”.
Slovenian: Zdravila Opsumit ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli,
English: However, undesirable effects may occur (e.g., headache, hypotension) that may influence the ability to drive and use machines (see section
Slovenian: hipotenzija), ki lahko vplivajo na sposobnost vožnje in upravljanja strojev (glejte poglavje 4.8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg macitentana.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg tablets macitentan
Slovenian: IME ZDRAVILA Opsumit 10 mg tablete macitentan
English: • carbamazepine (used to treat depression and epilepsy),
Slovenian: • fenitoin (zdravilo, ki se uporablja za zdravljenje epileptičnih napadov), • karbamazepin (zdravilo, ki se uporablja za zdravljenje depresije in epilepsije),
English: • Influenza (flu)
Slovenian: • faringitis (vnetje žrela) • influenca (gripa)
English: At clinically relevant concentrations, macitentan and its active metabolite do not interact with proteins involved in hepatic bile salt transport, i.e., the bile salt export pump (BSEP) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Slovenian: Macitentan in njegov aktivni presnovek v klinično koncentracijah ne delujejo medsebojno z beljakovinami, ki sodelujejo pri jetrnem prenosu žolčne soli, tj. z eksportno črpalko žolčne soli
English: Symptomatic endpoints
Slovenian: Simptomatski opazovani dogodki
English: Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”.
Slovenian: Zdravilo Opsumit vsebuje zdravilno učinkovino macitentan, ki sodi v razred zdravil, imenovanih
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Opsumit in vsebina pakiranja
English: What you need to know before you take Opsumit
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Opsumit Ne jemljite zdravila Opsumit:
English: Opsumit contains soya bean lecithin.
Slovenian: Tablete zdravila Opsumit vsebujejo sojin lecitin.
English: Testicular tubular atrophy, and minimal effects on reproductive variables and sperm morphology were recorded at exposures 3.8-fold the human exposure.
Slovenian: Pri izpostavljenosti, ki je bila 3,8-krat večja kot izpostavljenost pri ljudeh, so opazili testikularno tubularno atrofijo in minimalni učinek na spremenljivke reprodukcije in morfologijo sperme.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets
Slovenian: IME ZDRAVILA Opsumit 10 mg filmsko obložene tablete
English: Thrombocytopenia7
Slovenian: pogosti trombocitopenija7
English: The pharmacokinetics of macitentan and its active metabolite were not affected by warfarin.
Slovenian: Varfarin ni vplival na farmakokinetiko macitentana in njegovega aktivnega presnovka.
English: In a longterm double-blind study in patients with PAH, the incidence of oedema AEs in the macitentan 10 mg and placebo treatment groups was 21.9% and 20.5%, respectively.
Slovenian: dvojno slepi študiji z bolniki s PAH je bila incidenca neželenega učinka edema 21,9 % v skupini, ki je prejemala macitentan 10 mg, in 20,5 % v skupini, ki je prejemala placebo.
English: ©2013 Actelion Pharmaceuticals Ltd
Slovenian: Če imate dodatna vprašanja o zdravljenju, se posvetujte z zdravnikom ali farmacevtom.©2013 Actelion Pharmaceuticals Ltd
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti kongestija nosu1
English: • St. John's Wort (an herbal preparation used to treat depression),
Slovenian: • šentjanževko (zeliščni pripravek, ki se uporablja za zdravljenje depresije),
English: • If it is possible you could become pregnant, use a reliable form of birth control (contraception)
Slovenian: • Če lahko zanosite, morate med zdravljenjem z zdravilom Opsumit uporabljati učinkovit način preprečevanja nosečnosti (kontracepcijo).
English: Do not breastfeed while you are taking Opsumit.
Slovenian: Med uporabo zdravila Opsumit ne smete dojiti.
English: NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets macitentan
Slovenian: IME ZDRAVILA Opsumit 10 mg filmsko obložene tablete macitentan
English: • dark-coloured urine
Slovenian: • temno obarvan urin • srbenje kože
English: Sildenafil: At steady-state, the exposure to sildenafil 20 mg three times a day was increased by 15% during concomitant administration of macitentan 10 mg once daily.
Slovenian: Sildenafil: V stanju dinamičnega ravnovesja se je izpostavljenost sildenafilu 20 mg trikrat na dan zvečala za 15 % med sočasno uporabo macitentana 10 mg enkrat na dan. Sildenafil, ki je substrat CYP3A4, ni vplival na farmakokinetiko macitentana, medtem ko se je izpostavljenost aktivnemu presnovku macitentana zmanjšala za 15 %.
English: C.
Slovenian: HRa
English: Nasopharyngitis
Slovenian: Kaplan-Meierju
English: Hypotension2
Slovenian: Žilne bolezni pogosti hipotenzija2
English: Macitentan and its active metabolite are not inhibitors of hepatic or renal uptake transporters at clinically relevant concentrations, including the organic anion transporting polypeptides (OATP1B1 and OATP1B3).
Slovenian: Macitentan in njegov aktivni presnovek v klinično pomembnih koncentracijah nista zaviralca jetrnih ali ledvičnih privzemnih prenašalcev, vključno z organskimi anionskimi prenašalskimi polipeptidi
English: Outcome endpoints
Slovenian: Izidi opazovanega dogodka
English: Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
Slovenian: Macitentan so dajali zdravim osebam v enkratnem odmerku do 600 mg. Od neželenih učinkov so opazili glavobol, navzeo in bruhanje.
English: Bronchitis
Slovenian: Hemoglobin
English: In a double-blind study in patients with PAH, macitentan 10 mg was associated with a decrease in mean leucocyte count from baseline of 0.7 × 109/L versus no change in placebo-treated patients.
Slovenian: V dvojno slepi študiji pri bolnikih s PAH je bil macitentan 10 mg povezan z zmanjšanjem povprečnega števila levkocitov glede na izhodišče za 0,7 × 10
English: • rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),
Slovenian: Če jemljete katerega koli od spodaj navedenih zdravil, se posvetujte z zdravnikom ali farmacevtom: • rifampicin, klaritromicin, telitromicin (antibiotiki, ki se uporabljajo za zdravljenje okužb),
English: Film coating
Slovenian: ZA SPROŠČANJE SERIJ
English: • if you are breastfeeding.
Slovenian: • če dojite.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema občasni preobčutljivostne reakcije
English: Hepatobiliary disorders
Slovenian: Hemodinamski opazovani dogodki
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti anemija, zmanjšana raven hemoglobina5
English: • Thrombocytopenia (decreased blood platelet counts)
Slovenian: • trombocitopenija (zmanjšane ravni trombocitov)
English: Poly(vinyl-alcohol) (E1203)
Slovenian: Filmska obloga poli(vinilalkohol) (E1203) titanov dioksid (E171) smukec (E553b) sojin lecitin (E322) ksantanski gumi (E415)
English: • Asthma
Slovenian: • astma
English: The application for Dexamethasone Alapis has therefore been made in accordance with Article 10a of Directive 2001/83/EC, as amended.
Slovenian: Vloga za zdravilo Dexamethasone Alapis je bila zato predložena v skladu s členom 10(a) Direktive 2001/83/ES, kakor je bila spremenjena.
English: This corresponds to over 180 literature reports (Randomized Clinical Trials (RCTs); Reviews, Monographs (Martindale etc.).
Slovenian: To ustreza več kot 180 poročilom iz literature (randomizirana klinična preskušanja, pregledi, monografije (Martindale itd.)).
English: Overall summary of the scientific evaluation of Dexamethasone Alapis
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Dexamethasone Alapis
English: It is used principally as an anti-inflammatory or immunosuppressant agent.
Slovenian: Uporablja se predvsem kot protivnetno ali imunosupresivno zdravilo.
English: Elixirs are sweetened hydro-alcoholic oral solutions that are specially formulated for oral use in infants and children (Strickley, 2004).
Slovenian: Eliksirji so sladkane vodno-alkoholne peroralne raztopine, ki so namenjene posebej za peroralno uporabo pri dojenčkih in otrocih (Strickley, 2004).
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE
English: • Prevention of nausea and vomiting and treatment of cancer with oncolytics that have a serious emetic effect.
Slovenian: • preprečevanje slabosti in bruhanja ter zdravljenje raka z onkolitičnimi zdravili z močnim emetičnim učinkom.
English: It also showed that dexamethasone had a broad therapeutic index.
Slovenian: Pokazala je tudi, da ima deksametazon širok terapevtski indeks.
English: • Treatment of non-endocrine corticosteroid responsive conditions
Slovenian: • zdravljenje neendokrinih bolezni, ki se odzivajo na zdravljenje s kortikosteroidi
English: The Summary of Product Characteristics achieved during the Coordination group procedure was considered to address adequately the safety concerns of this medicinal product.
Slovenian: Povzetek glavnih značilnosti zdravila, ki je bil pripravljen v postopku usklajevalne skupine, je ustrezno obravnaval varnostne zadržke za to zdravilo.
English: This active substance is considered to have a ‘well-established use' within the European Community for at least 10 years, with recognised efficacy and an acceptable level of safety in the use in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction.
Slovenian: Za zdravilno učinkovino velja, da ima v Evropski skupnosti „dobro uveljavljeno uporabo“ že vsaj 10 let s priznano učinkovitostjo in sprejemljivo ravnjo varnosti pri uporabi pri nekaterih boleznih endokrinega in neendokrinega sistema, v nekaterih primerih cerebralnega edema in za diagnostično testiranje adrenokortikalne hiperfunkcije.
English: Dexamethasone has a biological half life of 36 - 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required.
Slovenian: Deksametazon ima biološko razpolovno dobo 36-54 ur, zato je primeren za zdravljenje stanj, pri katerih je zahtevano stalno glukokortikoidno delovanje.
English: The mechanism of action is mediated via activation of glucorticoid receptors that leads to increased or decreased transcription of a number of genes involved in the inflammatory process, particularly the repression of cytokine gene transcription and the direct interaction between the glucocorticoid receptor and other transcription factors activated in chronic inflammation.
Slovenian: Mehanizem delovanja izhaja iz aktiviranja glukokortikoidnih receptorjev, ki privede do povečane ali zmanjšane transkripcije številnih genov, ki sodelujejo v vnetnem procesu, zlasti do zmanjšane transkripcije gena citokina ter neposrednega medsebojnega delovanja glukokortikoidnega receptorja in drugih faktorjev transkripcije, ki se aktivirajo pri kroničnem vnetju.
English: Therefore, from a pharmaceutical perspective, elixirs are a type of oral solutions and are expected to behave in vivo as such.
Slovenian: S farmacevtskega vidika so eliksirji torej vrsta peroralnih raztopin in naj bi tako učinkovali tudi in vivo.
English: From the literature submitted during the decentralised procedure, it was shown that dexamethasone has been widely used in clinical practice for a number of indications for more than 40 years.
Slovenian: Iz literature, predložene med decentraliziranim postopkom, je razvidno, da se deksametazon v klinični praksi pri številnih indikacijah množično uporablja že več kot 40 let.
English: The strength and quality of evidence gathered from the above information was considered adequate for a medicinal product with a well established and broad therapeutic index as dexamethasone.
Slovenian: Pomen in kakovost dokazov, zbranih iz zgoraj navedenih informacij, sta veljala za ustrezna za zdravilo z dobro uveljavljenim in širokim terapevtskim indeksom, kot je deksametazon.
English: The Applicant specifically focussed its response on the concerns raised about bridging data.
Slovenian: Predlagatelj je v svojem odgovoru obravnaval predvsem vprašanja glede premostitvenih podatkov.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Slovenian: Ta je ocenil dokumentacijo in razpoložljive podatke, vključno z vprašanji, ki jih je izpostavila ugovarjajoča zadevna država članica.
English: At Day 60 of the CMD(h) procedure, since no agreement could be reached, the procedure was referred to the CHMP.
Slovenian: Ker sporazum ni bil dosežen, j e bil na 60. dan postopka CMD(h) postopek napoten na CHMP.