FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who experience a decrease in response on tofacitinib 5 mg twice daily maintenance therapy may benefit from an increase to tofacitinib 10 mg administered twice daily.
Slovenian: Pri bolnikih, pri katerih se odziv na vzdrževalno zdravljenje s 5 mg tofacitiniba dvakrat na dan zmanjša, je lahko koristno povečanje odmerka na 10 mg dvakrat na dan.
English: In the randomised 8-week Phase 2/3 induction studies, the proportions of patients with infections were 21.1% (198 patients) in the tofacitinib 10 mg twice daily group compared to 15.2% (43 patients) in the placebo group.
Slovenian: faze je bil delež bolnikov z okužbami 21,1 % (198 bolnikov) v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan, v primerjavi s 15,2 % (43 bolnikov) v skupini, ki je prejemala placebo.
English: In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with tofacitinib 10 mg twice daily achieved remission and improvement of endoscopic appearance of the mucosa at week 8 as compared to placebo.
Slovenian: Tako v podskupini bolnikov s predhodnim neučinkovitim zdravljenjem z zaviralcem TNF kot v podskupini brez njega so remisijo in izboljšanje endoskopskega videza sluznice po 8 tednih opazili pri večjem deležu bolnikov, ki so jih zdravili z 10 mg tofacitiniba dvakrat na dan, v primerjavi s placebom.
English: Hibernomas (malignancy of brown adipose tissue) were observed in female rats at exposures greater than or equal to 83 or 41 times the clinical exposure level at 5 mg or 10 mg twice daily.
Slovenian: Pri samicah podgan so pri izpostavljenostih, ki so bile enake ali večje od 83-kratne oziroma 41-kratne klinične izpostavljenosti pri odmerku 5 mg oziroma 10 mg dvakrat na dan, opazili hibernome (maligno bolezen rjavega maščobnega tkiva).
English: Both TNF inhibitor naïve and TNF inhibitor inadequate responder tofacitinib 5 mg BID -treated patients had significantly higher ACR20 response rates compared to placebo at month 3.
Slovenian: Tako bolniki, ki se predhodno niso zdravili z antagonistom TNF, kot bolniki, ki se nanj niso zadostno odzvali, so po 3 mesecih zdravljenja s 5 mg tofacitiniba dvakrat na dan imeli pomembno večjo stopnjo odziva ACR20 v primerjavi z bolniki, ki so prejemali placebo.
English: Treatment should be symptomatic and supportive.
Slovenian: Specifičnega antidota za preveliko odmerjanje tofacitiniba ni. Zdravljenje mora biti simptomatsko in podporno.
English: EU/1/17/1178/012 28 prolonged-release tablets EU/1/17/1178/013 91 prolonged-release tablets
Slovenian: EU/1/17/1178/012 28 tablet s podaljšanim sproščanjem EU/1/17/1178/013 91 tablet s podaljšanim sproščanjem
English: Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Slovenian: Primarni opazovani dogodek: remisijo so opredelili kot klinična remisija (ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
English: EU/1/17/1178/010 30 prolonged-release tablets EU/1/17/1178/011 90 prolonged-release tablets
Slovenian: EU/1/17/1178/010 30 tablet s podaljšanim sproščanjem EU/1/17/1178/011 90 tablet s podaljšanim sproščanjem
English: For patients (total 3,117) on background DMARDs, the rates were 41.0 and 50.3 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Slovenian: Pri bolnikih, ki so prejemali osnovno zdravljenje z DMARD (skupno 3.117), je bila pri odmerku 5 mg dvakrat na dan incidenca 41,0 bolnika z dogodki na 100 bolnikov-let, pri odmerku 10 mg dvakrat na dan pa 50,3 bolnika z dogodki na 100 bolnikov-let.
English: Do not swallow the dessicant.
Slovenian: Ne zaužijte sušilnega sredstva.
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Slovenian: V kliničnih preskušanjih pri bolnikih z RA je bila pri kombinaciji tofacitiniba z MTX incidenca neželenih učinkov večja kot pri monoterapiji s tofacitinibom.
English: Evidence of humoral and cell-mediated responses to VZV was observed in both tofacitinib and placebo-treated patients at 6 weeks.
Slovenian: V 6. tednu so pri bolnikih, ki so prejemali tofacitinib, in tistih, ki so prejemali placebo, opazili znake humoralnega in celičnega odziva na VZV.
English: Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Slovenian: Nezadosten odziv na najmanj 1 antagonist TNF (TNFi) zaradi nezadostne učinkovitosti in/ali intolerance.
English: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Slovenian: Remisijo so opredelili kot klinična remisija (ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of
Slovenian: Remisijo so opredelili kot klinična remisija (celokupna ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
English: Background treatment
Slovenian: peroralna uporaba
English: Placebo Tofacitinib 5 mg twice daily
Slovenian: placebo tofacitinib 5 mg dvakrat na dan
English: Tofacitinib exposure is increased when coadministered with potent inhibitors of CYP3A4 (e.g., ketoconazole) or when administration of one or more concomitant medicinal products results in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) (see section 4.2).
Slovenian: Pri sočasni uporabi močnih zaviralcev CYP3A4 (npr. ketokonazola) ali kadar sočasna uporaba enega ali več zdravil (npr. flukonazola) povzroči tako zmerno zaviranje CYP3A4 kot tudi močno zaviranje CYP2C19, se izpostavljenost tofacitinibu zveča (glejte poglavje 4.2).
English: XELJANZ 10 mg tablets tofacitinib
Slovenian: XELJANZ 10 mg tablete tofacitinib
English: XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
Slovenian: XELJANZ 10 mg filmsko obložene tablete - Učinkovina je tofacitinib.
English: Tofacitinib 10 mg twice daily N=476
Slovenian: tofacitinib 10 mg dvakrat na dan n = 476
English: XELJANZ 11 mg prolonged-release tablets
Slovenian: XELJANZ 11 mg tablete s podaljšanim sproščanjem
English: - Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Slovenian: - Ena 11 mg tableta s podaljšanim sproščanjem vsebuje 11 mg tofacitiniba (v obliki tofacitinibijevega citrata).
English: XELJANZ 5 mg tablets tofacitinib
Slovenian: XELJANZ 5 mg tablete tofacitinib
English: Each prolonged-release tablet contains tofacitinib citrate, equivalent to 11 mg tofacitinib.
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje tofacitinibijev citrat v količini, ki ustreza 11 mg tofacitiniba.
English: ANC greater than 1,000 Dose should be maintained.
Slovenian: ANC večje od 1.000
English: - XELJANZ 11 mg prolonged-release tablet is pink and oval in appearance.
Slovenian: - Zdravilo XELJANZ 11 mg tablete s podaljšanim sproščanjem so rožnate in ovalne.
English: Patients were to be in clinical response at baseline of the maintenance study OCTAVE Sustain.
Slovenian: Ob izhodišču preskušanja vzdrževalnega zdravljenja OCTAVE Sustain je moral biti pri bolnikih prisoten klinični odziv.
English: Tofacitinib 5 mg twice daily N=198
Slovenian: tofacitinib 5 mg dvakrat na dan n = 198
English: For recommended modifications based on lymphocyte counts, see section 4.2.
Slovenian: Za priporočene prilagoditve glede na število limfocitov glejte poglavje 4.2.
English: Lymphomas have been observed in patients treated with tofacitinib.
Slovenian: Pri bolnikih, zdravljenih s tofacitinibom, so opazili limfome.
English: Tofacitinib dose should be reduced to 5 mg (as film-coated tablet) once daily in patients receiving 11 mg (as prolonged-release tablet) once daily (see section 4.2).
Slovenian: Pri bolnikih, ki prejemajo 11 mg tofacitiniba (v obliki tablete s podaljšanim sproščanjem) enkrat na dan, je treba odmerek tofacitiniba zmanjšati na 5 mg (v obliki filmsko obložene tablete) enkrat na dan (glejte poglavje 4.2).
English: Tofacitinib 5 mg twice daily + DMARD(s)
Slovenian: tofacitinib 5 mg dvakrat na dan + DMARD****
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tofacitinib.
Slovenian: Med zdravljenjem s tofacitinibom in po njem je treba bolnike skrbno spremljati glede pojava znakov in simptomov okužb.
English: XELJANZ has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.
Slovenian: Dokazali so, da zdravilo XELJANZ samostojno ali v kombinaciji z metotreksatom zmanjša bolečine in otekanje sklepov ter izboljša sposobnost izvajanja vsakodnevnih dejavnosti.
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Slovenian: Ena filmsko obložena tableta vsebuje tofacitinibijev citrat v količini, ki ustreza 5 mg tofacitiniba.
English: *p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Slovenian: *p < 0,05 **p < 0,001 ***p < 0,0001 v primerjavi s placebom (v primerjavi z MTX pri ORAL Start) **** eno ali več DMARD ǂp < 0,05 - tofacitinib 5 mg + MTX v primerjavi s tofacitinibom 5 mg pri ORAL Strategy (normalne p-vrednosti brez korekcije za večkratne primerjave) n = število analiziranih preskušancev, ACR20/50/70 = izboljšanje za ≥ 20 %, 50 %, 70 % po merilih ACR, NA = ni na voljo, MTX = metotreksat.
English: • fever and chills
Slovenian: • vročino ali mrzlico,
English: In the long-term safety all exposure population, the overall rates of serious infections were 2.4 and 3.0 patients with events per 100 patient-years for 5 mg and 10 mg twice daily tofacitinib groups, respectively.
Slovenian: Pri vsej izpostavljeni populaciji, pri kateri so preučevali dolgoročno varnost, je bila celokupna stopnja resnih okužb v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan, 2,4 bolnika z dogodki na 100 bolnikov-let, v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan, pa 3,0 bolnika z dogodki na 100 bolnikov-let.
English: XELJANZ 5 mg film-coated tablet - The active substance is tofacitinib.
Slovenian: XELJANZ 5 mg filmsko obložene tablete - Učinkovina je tofacitinib.
English: Placebo N=112
Slovenian: Opazovani dogodek placebo n = 112
English: Cough
Slovenian: huda
English: Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Slovenian: Ena filmsko obložena tableta vsebuje tofacitinibijev citrat v količini, ki ustreza 10 mg tofacitiniba.
English: In the MTX group, 70% of patients experienced no radiographic progression at month 6 compared to 83% and 90% of patients treated with tofacitinib 5 mg or 10 mg twice daily respectively, both significant versus MTX.
Slovenian: V skupini, ki je prejemala MTX, v 6. mesecu pri 70 % bolnikov bolezen ni radiografsko napredovala v primerjavi s 83 % bolnikov v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan, in 90 % bolnikov v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan (oba rezultata sta statistično pomembna v primerjavi s skupino, ki je prejemala MTX).
English: Tofacitinib 10 mg twice daily N=197
Slovenian: tofacitinib 10 mg dvakrat na dan n = 197
English: XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
Slovenian: XELJANZ 5 mg filmsko obložene tablete XELJANZ 10 mg filmsko obložene tablete
English: N ORAL Step: TNF inhibitor inadequate responders Tofacitinib 5 mg twice daily + MTX
Slovenian: Časovna točka ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF tofacitinib 5 mg dvakrat na dan + MTX
English: In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in the total and all 4 domain scores of the IBDQ at week 24 and week 52.
Slovenian: V preskušanju vzdrževalnega zdravljenja (OCTAVE Sustain) se je izboljšanje celokupne ocene in ocen v vseh 4 domenah vprašalnika IBDQ po 24 in 52 tednih bolje ohranilo pri uporabi 5 mg tofacitiniba dvakrat na dan ali 10 mg tofacitiniba dvakrat na dan v primerjavi s placebom.
English: In the controlled portion of the RA phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V nadzorovanem delu preskušanja 3. faze z osnovnim zdravljenjem z DMARD pri bolnikih z RA (0-3 meseci) (Preskušanje II-V, glejte poglavje 5.1), so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 0,9 % bolnikov, ki so prejemali placebo, 1,24 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 1,14 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: Switching between tofacitinib 11 mg prolonged-release tablets and tofacitinib 5mg film-coated tablets
Slovenian: Prehod s tofacitiniba 11 mg tablete s podaljšanim sproščanjem na tofacitinib 5 mg filmsko obložene tablete
English: Tofacitinib 5 mg film-coated tablets
Slovenian: Tofacitinib 5 mg filmsko obložene tablete
English: XELJANZ 11 mg prolonged-release tablets tofacitinib
Slovenian: XELJANZ 11 mg tablete s podaljšanim sproščanjem tofacitinib
English: In this study, AST elevations greater than 3x ULN were observed in 3.3%, 1.6% and 1.5% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V tem preskušanju so zvečanja vrednosti AST, večja od 3-kratne vrednosti ZMN, opazili pri 3,3 % bolnikov, ki so prejemali MTX, 1,6 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 1,5 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: Tofacitinib 10 mg twice daily N=429
Slovenian: tofacitinib 10 mg dvakrat na dan n = 429
English: In these studies, AST elevations greater than 3x ULN were observed in 0.72%, 0.5% and 0.31% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V teh preskušanjih so zvečanja vrednosti AST, večja od 3-kratne vrednosti ZMN, opazili pri 0,72 % bolnikov, ki so prejemali placebo, 0,5 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 0,31 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: ORAL Strategy: MTX inadequate responders
Slovenian: ORAL Strategy: bolniki z nezadostnim odzivom na MTX
English: Tofacitinib 10 mg film-coated tablets
Slovenian: Tofacitinib 10 mg filmsko obložene tablete
English: * p<0.0001; † p<0.001; ‡ p<0.05.
Slovenian: * p < 0,0001; † p < 0,001; ‡ p < 0,05. n = število bolnikov v analizirani skupini.
English: In the RA phase 3 monotherapy study (0-24 months) (study VI, see section 5.1), ALT elevations greater than 3x ULN were observed in 7.1%, 3.0%, and 3.0% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V preskušanju 3. faze z monoterapijo pri bolnikih z RA (0-24 mesecev) (Preskušanje VI, glejte poglavje 5.1) so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 7,1 % bolnikov, ki so prejemali MTX, 3,0 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 3,0 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: NA ORAL Step: TNF Inhibitor inadequate responders
Slovenian: NA ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
English: Tofacitinib 10 mg twice daily + DMARD(s) N=315
Slovenian: tofacitinib 10 mg dvakrat na dan + DMARD**** n = 315
English: • rheumatoid arthritis
Slovenian: • revmatoidni artritis,
English: NMSCs have been reported in patients treated with tofacitinib.
Slovenian: Pri bolnikih, zdravljenih s tofacitinibom, so opazili primere NMSC.
English: Tofacitinib 5 mg twice daily + MTX
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX
English: Remissiona With prior TNF inhibitor failure
Slovenian: remisija predhodno neučinkovito zdravljenje z zaviralcem TNF
English: BLISTER FOR 5 MG TABLETS
Slovenian: PRETISNI OMOT ZA 5 MG TABLETE
English: Do not crush, split, or chew.
Slovenian: Tablet ne zdrobite, razpolovite ali žvečite.
English: ORAL Scan: MTX inadequate responders
Slovenian: NA ORAL Scan: bolniki z nezadostnim odzivom na MTX
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Preskušanje VI (ORAL
English: Tofacitinib 5 mg twice daily + MTX N=376
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX n = 376
English: In controlled phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients).
Slovenian: V nadzorovanih kliničnih preskušanjih 3. faze, v katerih so bolniki prejemali osnovno zdravljenje z DMARD, je bila stopnja okužb v 0-3 mesecih 21,3 % (207 bolnikov) v skupini, ki je prejemala 5 mg tofacitiniba in DMARD dvakrat na dan (skupno 973 bolnikov), in 21,8 % (211 bolnikov) v skupini, ki je prejemala 10 mg tofacitiniba in DMARD dvakrat na dan (skupno 969 bolnikov), v primerjavi z 18,4 % (103 bolniki) v skupini, ki je prejemala placebo in DMARD (skupno 559 bolnikov).
English: Month 3 Month 6 Month 12
Slovenian: 3. mesec 6. mesec 12. mesec
English: Tofacitinib was not carcinogenic in mice at exposures up to 38 or 19 times the clinical exposure level at 5 mg or 10 mg twice daily.
Slovenian: Pri miših pri izpostavljenostih, ki so do 38-krat oziroma 19-krat presegale raven klinične izpostavljenosti pri odmerku 5 mg oziroma 10 mg dvakrat na dan, tofacitinib ni bil kancerogen.
English: Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post-marketing reports.
Slovenian: Pri bolnikih, ki so tofacitinib prejemali v kliničnih preskušanjih in v obdobju trženja zdravila, so opazili primere pljučne embolije (PE).
English: Tofacitinib 5 mg twice daily N=384
Slovenian: Čas tofacitinib 5 mg dvakrat na dan n = 384
English: BLISTER FOR 10 MG TABLETS
Slovenian: PRETISNI OMOT ZA 10 MG TABLETE
English: In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg film-coated tablets twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Slovenian: V nadzorovanih kliničnih preskušanjih 3. faze je bila stopnja okužb v 0-3 mesecih 16,2 % (100 bolnikov) v skupini, ki je prejemala monoterapijo s 5 mg filmsko obloženimi tabletami tofacitiniba dvakrat na dan (skupno 616 bolnikov), in 17,9 % (115 bolnikov) v skupini, ki je prejemala monoterapijo z 10 mg tofacitiniba dvakrat na dan (skupno 642 bolnikov), v primerjavi z 18,9 % (23 bolnikov) v skupini, ki je prejemala placebo (skupno 122 bolnikov).
English: Each prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Slovenian: Ena tableta s podaljšanim sproščanjem vsebuje 11 mg tofacitiniba (v obliki tofacitinibijevega citrata).
English: • Heart failure
Slovenian: • srčno popuščanje,
English: A significantly greater proportion of patients treated with tofacitinib 10 mg twice daily achieved remission, improvement of endoscopic appearance of the mucosa, and clinical response at week 8 compared to placebo in both studies, as shown in Table 15.
Slovenian: V obeh preskušanjih so remisijo, izboljšanje endoskopskega videza sluznice in klinični odziv po 8 tednih opazili pri pomembno večjem deležu bolnikov, ki so jih zdravili z 10 mg tofacitiniba dvakrat na dan, v primerjavi s placebom, kot je prikazano v preglednici 15.
English: Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Slovenian: c podatki v 6. in 12. mesecu so povprečna sprememba glede na izhodišče d razlika med povprečji najmanjših kvadratov tofacitiniba minus MTX (95 % IZ = 95-odstotni interval zaupanja)
English: Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see section 4.5) as follows:
Slovenian: Pri bolnikih, ki prejemajo močne zaviralce citokroma P450 (CYP) 3A4 (npr. ketokonazol), in pri bolnikih, ki sočasno prejemajo 1 ali več zdravil, ki zmerno zavirajo CYP3A4 in hkrati močno zavirajo CYP2C19 (npr. flukonazol) (glejte poglavje 4.5), je treba skupni dnevni odmerek tofacitiniba zmanjšati za polovico, kot sledi:
English: Tofacitinib 5 mg twice daily N=344 Mean (SD)a
Slovenian: tofacitinib 5 mg dvakrat na dan n = 344 povprečje (SD)
English: EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
Slovenian: EU/1/17/1178/007 56 filmsko obloženih tablet EU/1/17/1178/008 112 filmsko obloženih tablet EU/1/17/1178/009 182 filmsko obloženih tablet
English: Tofacitinib 10 mg twice daily
Slovenian: TOFACITINIB 10 mg dvakrat na dan
English: ΔLEIf Month 3 Month 6 Month 12
Slovenian: ΔDSS 3. mesec 6. mesec 12. mesec
English: Tofacitinib 10mg twice daily N=368 Mean (SD)a
Slovenian: tofacitinib 10 mg dvakrat na dan n = 368 povprečje (SD)
English: In this study, AST elevations greater than 3x ULN were observed in 1.65%, 0.41% and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V tem preskušanju so zvečanja vrednosti AST, večja od 3-kratne vrednosti ZMN, opazili pri 1,65 % bolnikov, ki so prejemali placebo, 0,41 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 0 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
Slovenian: EU/1/17/1178/003 56 filmsko obloženih tablet EU/1/17/1178/004 182 filmsko obloženih tablet EU/1/17/1178/014 112 filmsko obloženih tablet
English: EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Slovenian: EU/1/17/1178/005 60 filmsko obloženih tablet EU/1/17/1178/006 180 filmsko obloženih tablet
English: Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Slovenian: Navodilo za uporabo XELJANZ 5 mg filmsko obložene tablete XELJANZ 10 mg filmsko obložene tablete tofacitinib
English: Tofacitinib 5 mg twice daily + MTX N=277 Mean (SD)a
Slovenian: tofacitinib 5 mg dvakrat na dan + MTX n = 277 povprečje (SD)
English: In the maintenance study (OCTAVE Sustain), tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily demonstrated greater maintenance of improvement compared to placebo in PCS and MCS scores, and in all 8 domains of the SF-36 at week 24 and week 52.
Slovenian: V preskušanju vzdrževalnega zdravljenja (OCTAVE Sustain) se je izboljšanje rezultatov PCS in MCS ter v vseh 8 domenah vprašalnika SF-36 po 24 in 52 tednih bolje ohranilo pri uporabi 5 mg tofacitiniba dvakrat na dan ali 10 mg tofacitiniba dvakrat na dan v primerjavi s placebom.
English: In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Slovenian: V nadzorovanih kliničnih preskušanjih 3. faze je bila stopnja okužb v 0-3 mesecih 16,2 % (100 bolnikov) v skupini, ki je prejemala monoterapijo s 5 mg tofacitiniba dvakrat na dan (skupno 616 bolnikov), in 17,9 % (115 bolnikov) v skupini, ki je prejemala monoterapijo z 10 mg tofacitiniba dvakrat na dan (skupno 642 bolnikov), v primerjavi z 18,9 % (23 bolnikov) v skupini, ki je prejemala placebo (skupno 122 bolnikov).