natgillin/translations-raw huggingface dataset:
Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers. 
Možnost vpliva tofacitiniba na farmakokinetiko drugih zdravil Sočasna uporaba tofacitiniba pri zdravih prostovoljkah ni imela vpliva na farmakokinetiko peroralnih kontraceptivov, levonorgestrela in etinilestradiola.
Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib. 
Ena 10 mg filmsko obložena tableta vsebuje tofacitinibijev citrat v količini, ki ustreza 10 mg tofacitiniba.
d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE 
Odprto podaljšano preskušanje (OCTAVE Open) Bolniki, ki v enem od preskušanj indukcijskega zdravljenja (OCTAVE Induction 1 ali OCTAVE
CYP3A & CYP2C19 Inhibitor Fluconazole 
AUC Cmax zaviralec CYP3A4 ketokonazol zaviralec CYP3A in CYP2C19 flukonazol induktor CYP rifampicin metotreksat takrolimus ciklosporin
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13). 
Pri bolnikih, ki so prejemali 5 mg tofacitiniba dvakrat na dan, so po 3 mesecih opazili večje izboljšanje (p ≤ 0,05) telesne funkcije od izhodišča v primerjavi s placebom (glejte preglednico 13).
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. 
Pri samicah podgan so pri izpostavljenostih, ki so bile enake ali večje od 83-kratne oziroma 41-kratne ravni klinične izpostavljenosti pri odmerku 5 mg oziroma 10 mg dvakrat na dan, opazili hibernome (maligno bolezen rjavega maščobnega tkiva).
Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of tofacitinib. 
Pred uporabo tofacitiniba in med njo, skladno z veljavnimi smernicami, je treba bolnike pregledati ter testirati glede latentne ali aktivne okužbe.
NA ORAL Step: TNF Inhibitor Inadequate Responders 
NA ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
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). 
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).
Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob 
a tofacitinib 10 mg dvakrat na dan + MTX povprečna razlika glede na placebob
Placebo + MTX N=132 
Opazovani dogodek Čas placebo + MTX n = 132
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib 
IME ZDRAVILA XELJANZ 10 mg tablete tofacitinib
ACR20 Month 3 Month 6 
ACR20 3. mesec 6. mesec
Tofacitinib 10 mg Twice Daily N=476 
tofacitinib 10 mg dvakrat na dan n = 476
Tofacitinib 5 mg Twice Daily N=198 
tofacitinib 5 mg dvakrat na dan n = 198
Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased 
Preiskave zvečanje vrednosti kreatin-fosfokinaze v krvi zvečanje vrednosti jetrnih encimov, zvečanje vrednosti transaminaz, nenormalni izvidi testov jetrne funkcije, zvečanje vrednosti gamaglutamiltransferaze, zvečanje vrednosti kreatinina v krvi, zvečanje vrednosti holesterola v krvi, zvečanje vrednosti lipoproteinov nizke gostote, zvečanje telesne mase
Table 5: Dose Adjustment for Renal Impairment Renal 
Preglednica 5: Prilagajanje odmerka pri okvari ledvic Okvara ledvic Očistek kreatinina Prilagajanje odmerka blaga
Tofacitinib 5 mg Twice Daily + DMARD(s) 
tofacitinib 5 mg dvakrat na dan + DMARD****
ACR50 Month 3 Month 6 
ACR50 3. mesec 6. mesec
TNFi Inadequate Respondersb 
bolniki z nezadostnim odzivom na antagonist TNFb
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib 
IME ZDRAVILA XELJANZ 5 mg tablete tofacitinib
• Malignancy 
• malignost,
As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section 
Uporaba tofacitiniba med nosečnostjo je iz previdnosti kontraindicirana (glejte poglavje 4.3).
For patients (total 1,750) on monotherapy, the rates were 48.9 and 41.9 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively. 
1.750), je bila pri odmerku 5 mg dvakrat na dan incidenca 48,9 bolnika z dogodki na 100 bolnikov-let, pri odmerku 10 mg dvakrat na dan pa 41,9 bolnika z dogodki na 100 bolnikov-let.
Tofacitinib 10 mg Twice Daily N=197 
tofacitinib 10 mg dvakrat na dan n = 197
NA ORAL Scan: MTX Inadequate Responders 
ORAL Scan: bolniki z nezadostnim odzivom na MTX
ACR70 Month 3 Month 6 
ACR70 3. mesec 6. mesec
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. 
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.
Co-primary efficacy endpointsc 
Sočasni primarni opazovani dogodki učinkovitosti c
Tofacitinib 10 mg Twice Daily N=429 
tofacitinib 10 mg dvakrat na dan n = 429
4 weeks prior to the visit at both week 24 and week 52. f. N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily. 
n = 59 za placebo, n = 65 za 5 mg odmerek tofacitiniba dvakrat na dan, n = 55 za 10 mg odmerek tofacitiniba dvakrat na dan.
Do not take XELJANZ: - if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6) - if you have a severe infection such as bloodstream infection or active tuberculosis - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding 
Ne jemljite zdravila XELJANZ: - če ste alergični na tofacitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
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. 
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.
ORAL Strategy: MTX Inadequate Responders 
ORAL Strategy: bolniki z nezadostnim odzivom na MTX
inhibitors, effects on pregnancy and foetus, use in breastfeeding, effect on vaccination efficacy and the use of live/attenuated vaccines. 
uporabljeno v kombinaciji z MTX; povečana izpostavljenost zdravilu XELJANZ pri sočasni uporabi z zaviralci CYP3A4 in CYP2C19; učinki na nosečnost in plod; uporaba med dojenjem; vpliv na učinkovitost cepljenja in uporaba živih/oslabljenih cepiv; o kontaktne podatke predpisovalca.
With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failure b 
remisija a predhodno neučinkovito zdravljenje z zaviralcem TNF brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb izboljšanje endoskopskega videza sluznice c predhodno neučinkovito zdravljenje z zaviralcem TNF brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb
PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 56 filmsko obloženih tablet 112 filmsko obloženih tablet 182 filmsko obloženih tablet
Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a 
tofacitinib 10 mg dvakrat na dan n = 368 povprečje (SD)
Tofacitinib 10 mg Twice Daily + DMARD(s) N=315 
tofacitinib 10 mg dvakrat na dan + DMARD**** n = 315
Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post marketing reports. 
Pri bolnikih, ki so tofacitinib prejemali v kliničnih preskušanjih in v obdobju trženja zdravila, so opazili primere pljučne embolije (PE).
Tel : + 35621 344610 
Vivian Corporation Ltd. Tel: + 35621 344610
Tofacitinib 5 mg Twice Daily + MTX N=376 
tofacitinib 5 mg dvakrat na dan + MTX n = 376
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT ZA 10 MG TABLETE
Tofacitinib 5 mg Twice Daily N=384 
Čas tofacitinib 5 mg dvakrat na dan n = 384
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNI OMOT ZA 5 MG TABLETE
Tofacitinib 5 mg Twice Daily + MTX 
tofacitinib 5 mg dvakrat na dan + MTX
MARKETING AUTHORISATION NUMBER(S) 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 
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
Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo 
tofacitinib 10 mg dvakrat na dan placebo tofacitinib 10 mg dvakrat na dan placebo tofacitinib 5 mg dvakrat na dan tofacitinib 10 mg dvakrat na dan placebo
Treatment Group 
Prekinitev zdravljenja
MARKETING AUTHORISATION NUMBER(S) 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 
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
Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a 
tofacitinib 10 mg dvakrat na dan + MTX n = 290 povprečje (SD)
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies. 
V vseh 5 preskušanjih je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje utrujenosti glede na izhodišče pomembno večje v primerjavi s placebom.
Tofacitinib 10 mg Twice Daily + MTX N=309 
tofacitinib 10 mg dvakrat na dan + MTX n = 309
Tofacitinib 5 mg Twice Daily Monotherapy N=241 
Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 241
ORAL Step: TNF Inhibitor Inadequate Responders N=118 
ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
In the controlled portion of the RA Phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT 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. 
V nadzorovanem delu preskušanja 3. faze z monoterapijo pri bolnikih z RA (0-3 meseci) (Preskušanje I, glejte poglavje 5.1) so zvečanja vrednosti ALT, 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.
NA ORAL Standard: MTX Inadequate Responders 
NA ORAL Standard: bolniki z nezadostnim odzivom na MTX
Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a 
a tofacitinib 5 mg dvakrat na dan n = 344 povprečje (SD)
GENERAL CLASSIFICATION FOR SUPPLY 
Prilagajanje odmerka blaga
Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI) 
a tofacitinib 5 mg dvakrat na dan + MTX povprečna razlika glede na placebob
Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open). 
Induction 2) po 8 tednih zdravljenja z 10 mg tofacitiniba dvakrat na dan niso dosegli kliničnega odziva, so lahko sodelovali v odprtem podaljšanem preskušanju (OCTAVE Open).
Patients receiving either 5 or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step. 
V preskušanjih ORAL Solo, ORAL Scan in ORAL Step je bilo izboljšanje glede na izhodišče v 3. mesecu v primerjavi s placebom pomembno večje pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, v vseh 8 domenah, kot tudi pri rezultatih povzetka telesne komponente (Physical Component Summary) in povzetka duševne komponente (Mental Component Summary).
Normalization of endoscopic appearance of the mucosac 
remisija a izboljšanje endoskopskega videza sluzniceb normalizacija endoskopskega videza sluznice c klinični odzivd
Tofacitinib 5 mg Twice Daily Monotherapy N=370 
Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 370
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a 
a tofacitinib 5 mg dvakrat na dan + MTX n = 277 povprečje (SD)
Tofacitinib 10 mg Twice Daily + MTX N=134 
tofacitinib 10 mg dvakrat na dan + MTX n = 134
Tofacitinib 5 mg Twice Daily + MTX N=316 
tofacitinib 5 mg dvakrat na dan + MTX n = 316
Tel: +49 (0)30 550055-51000 
Pfizer Pharma GmbH Tel: +49 (0)30 550055-51000
Tofacitinib 5 mg Twice Daily + MTX N=133 
tofacitinib 5 mg dvakrat na dan + MTX n = 133
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana 
Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
ORAL Standard: MTX Inadequate Responders 
ORAL Standard: bolniki z nezadostnim odzivom na MTX
Pfizer Luxembourg SARL filialas Lietuvoje 
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Tofacitinib 5 mg Twice Daily + DMARD(s) N=312 
tofacitinib 5 mg dvakrat na dan + DMARD**** n = 312
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC 
Preglednica 14: Klinična preskušanja 3. faze uporabe tofacitiniba v odmerkih 5 in 10 mg dvakrat na dan pri bolnikih z UK OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Reduce Tofacitinib Dosea Reduce Tofacitinib Dosea May Decrease Efficacy 
Zmanjšajte odmerek tofacitiniba a.
With prior TNF inhibitor failure Without prior TNF inhibitor failureb 
brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb
Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI) 
a tofacitinib 5 mg dvakrat na dan povprečna razlika glede na MTXd
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets 
EU/1/17/1178/005 60 filmsko obloženih tablet EU/1/17/1178/006 180 filmsko obloženih tablet
Tofacitinib 10 mg Twice Daily Monotherapy N=394 
Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 394
Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispneja, kongestija sinusov
Tofacitinib 10 mg Twice Daily Monotherapy N=243 
Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 243
Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync. 
V preskušanjih ORAL Solo in ORAL Sync so pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, opazili pomembno izboljšanje telesne funkcije v primerjavi s placebom že po 2 tednih.
In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission, 
Tako v podskupini bolnikov s predhodnim neučinkovitim zdravljenjem z zaviralcem TNF kot v podskupini brez njega so po 52 tednih preskušanja OCTAVE Sustain pri pomembno večjem deležu bolnikov, ki so se zdravili s 5 mg tofacitiniba dvakrat na dan ali 10 mg tofacitiniba dvakrat na dan, kot v skupini s placebom potrdili naslednje opazovane dogodke: remisijo, izboljšanje endoskopskega videza sluznice ali ohranjeno remisijo brez jemanja kortikosteroidov po 24 in 52 tednih pri bolnikih, ki so bili ob izhodišču v remisiji (preglednica 18).
e. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 
Ohranjena remisija brez jemanja kortikosteroidov je pomenila, da je bil bolnik v remisiji in ni jemal kortikosteroidov vsaj 4 tedne pred obiskom po 24 tednih in obiskom po 52 tednih.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets 
EU/1/17/1178/001 60 filmsko obloženih tablet EU/1/17/1178/002 180 filmsko obloženih tablet
Pfizer Luxembourg SARL 
Luxembourg/Luxemburg Pfizer S.A.
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS 
NALEPKA ZA STIČNO OVOJNINO - PLASTENKO ZA 10 MG TABLETE
In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm occurred in 
V populaciji z RA, pri kateri so preučevali dolgoročno varnost, so zmanjšanje ALC pod 500 celic/mm3 potrdili pri skupno 1,3 % bolnikov, zmanjšanje ALC med 500 in 750 celic/mm3 pa pri skupno 8,4 %
Improvement of endoscopic appearance of the mucosa 
Pregled endoskopskih posnetkov na mestu kliničnega preskušanja
a. Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern). 
Ključni sekundarni opazovani dogodek: izboljšanje endoskopskega videza sluznice so opredelili kot endoskopska podocena Mayo 0 (normalen videz ali neaktivna bolezen) ali 1 (eritem, zmanjšan žilni vzorec).
Remissiona With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb OCTAVE Induction Study 2 
remisija a predhodno neučinkovito zdravljenje z zaviralcem TNF 10/89 brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb izboljšanje endoskopskega videza sluznice c predhodno neučinkovito zdravljenje z zaviralcem TNF 11/89
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS 
NALEPKA ZA STIČNO OVOJNINO - PLASTENKO ZA 5 MG TABLETE
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets 
XELJANZ 5 mg filmsko obložene tablete XELJANZ 10 mg filmsko obložene tablete
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg tofacitiniba (v obliki tofacitinibijevega citrata).
a. Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Included TNF Inhibitor naïve patients. 
Remisijo so opredelili kot klinična remisija (ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 5 mg tofacitiniba (v obliki tofacitinibijevega citrata).
Placebo Tofacitinib 5 mg Twice Daily 
placebo tofacitinib 5 mg dvakrat na dan n 3. mesec c,*
a. ≤3 weekly doses (MTX-naïve). 
≤ 3-tedenski odmerki (bolniki, ki še niso prejemali MTX).
Placebo + DMARD(s) N=158 
Opazovani dogodek Čas placebo + DMARD**** n = 158
It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3. 
Pri bolnikih s potrjenim številom limfocitov, manjšim od 750 celic/mm3, uvedba ali nadaljevanje zdravljenja s tofacitinibom nista priporočljivi.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months. 
bolnikov za skupini, ki sta prejemali odmerke 5 mg dvakrat na dan in 10 mg dvakrat na dan.
Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems - if you have or had hepatitis B or hepatitis C (viruses that affect the liver). 
- če imate ali ste imeli hepatitis B ali hepatitis C (virusa, ki prizadeneta jetra).
Baseline Month 6 
6. mesec placebo
Tofacitinib 10 mg Twice Daily + MTX 
3. mesec tofacitinib 10 mg dvakrat na dan + MTX
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan. 
V preskušanjih ORAL Sync, ORAL Standard in ORAL Scan je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje na obeh lestvicah glede na izhodišče pomembno večje v primerjavi s placebom.
Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral 
Bolezni jeter, žolčnika in žolčevodov jetrna steatoza
• Once only. 
• Samo enkrat.
Is this OK? 
Je to vredu?
Note: This may take up to 5 minutes. 
Opomba: To lahko traja do 5 minut.
Date of first authorization: 13 November 2002 Date of latest renewal: 20 September 2007 
Datum prve odobritve: 13. november 2002 Datum zadnjega podaljšanja: 20. september 2007
Some patients required hospitalization. 
Pri nekaterih bolnikih je bila potrebna hospitalizacija.
Before you start: 
Preden začnete:
You will need a replacement syringe. 
Potrebovali boste nadomestno brizgo.
What should I do if I have any doubts about my medicine? 
Kaj naj storim, če imam pomisleke glede svojega zdravila?
See also the section about Pregnancy below. 
Glejte tudi spodnje poglavje o nosečnosti.
The relevance of this response for humans is currently unknown. 
Pomen takšnega odziva za ljudi trenutno ni znan.
There is also a risk you may lose some of the medicine. 
Prav tako obstaja tveganje, da boste nekaj zdravila izgubili.
It may take more effort to snap off than you might expect. 
Morda ga bo težje odlomiti, kot ste mislili.
- Your doctor should also monitor your adenoma (benign tumour). 
Zdravnik mora prav tako spremljati vaš adenom (benigni tumor).
How many times can I safely insert the needle into the vial stopper? 
Kolikokrat lahko iglo varno zabodem v zamašek viale?
As part of your treatment you may be given other medicines. 
Kot del zdravljenja morda prejemate še druga zdravila.
The maximum dose should not exceed 30 mg/day. 
Največji odmerek ne sme preseči 30 mg/dan.
Things you need 
Kaj potrebujete
Adverse reactions are listed according to the following categories: Very common: 1/10 
Neželeni učinki so našteti po naslednjih skupinah: Zelo pogosti:  1/10
The apparent volume of distribution of pegvisomant is relatively small (7-12 L). 
Navidezni volumen porazdelitve pegvisomanta je razmeroma majhen (7-12 l).
Contact your doctor immediately if you develop any of these symptoms. 
Nemudoma obvestite zdravnika, če se vam pojavi katerikoli od teh simptomov.
This can cause discomfort and increases risk of skin damage and infection. 
To lahko povzroči neugodje in poveča tveganje za poškodbe kože in okužbe.