natgillin/translations-raw huggingface dataset:
Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines. 
XELJANZ ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Patients in the Phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline. 
Disease Activity Score, DAS28-4[ESR]) od 6,1 do 6,7.
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3. 
Preporuča se ne započinjati doziranje u bolesnika čiji je apsolutni broj neutrofila (ABN) manji od 1000 stanica/mm3.
Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open. 
Induction 1 ili OCTAVE Induction 2) postigli uz 10 mg tofacitiniba dva puta dnevno, ali su imali neuspješno liječenje nakon što je doza bila snižena na 5 mg tofacitiniba dva puta dnevno ili nakon prekida liječenja u ispitivanju OCTAVE Sustain (odnosno nakon što su bili randomizirani za primanje placeba).
ACR20 mTSS DAS284(ESR)<2.6 Month 3: 
6. mjesec: ACR20 mTSS DAS284(ESR) < 2
Month 6 ORAL Standard: MTX Inadequate Responders Tofacitinib 5 mg twice daily + MTX 
6. mjesec ORAL Standard: Bolesnici s neodgovarajućim odgovorom na MTX Tofacitinib 5 mg dva puta dnevno + MTX
In ORAL Standard and ORAL Scan, mean improvements in both scales were maintained to 12 months in tofacitinib-treated patients. 
U ispitivanjima ORAL Standard i ORAL Scan, srednja vrijednost poboljšanja na obje ljestvice održana su do 12 mjeseci u bolesnika liječenih tofacitinibom.
At baseline, 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively. 
Prije početka terapije 80,7% odnosno 49,2% bolesnika imalo je entezitis i daktilitis.
Hepatic steatosis 
Steatoza jetre
Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND 
PsA-a OPAL BROADEN i OPAL BEYOND
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 sections 4.4 and 4.5) as follows: 
Ukupnu dnevnu dozu tofacitiniba treba sniziti za pola u bolesnika koji primaju snažne inhibitore citokroma P450 (CYP) 3A4 (npr. ketokonazol) i u bolesnika koji istodobno primaju jedan ili više lijekova čija primjena rezultira umjerenom inhibicijom CYP3A4, kao i potentnom inhibicijom
Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known. 
Slučajevi gastrointestinalne perforacije prijavljeni su u kliničkim ispitivanjima, iako uloga JAK
• Patients undergoing major surgery 
• Maligna bolest • Bolesnici koji se podvrgavaju velikom operativnom zahvatu.
Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability. 
b Neadekvatan odgovor na najmanje jedan inhibitor TNF-a (TNFi) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
N ORAL Step: TNF Inhibitor Inadequate Responders Tofacitinib 5 mg twice daily + MTX 
N % ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitor Tofacitinib 5 mg dva puta dnevno + MTX
• who have resided or travelled in areas of endemic mycoses, 
• s anamnezom ozbiljne ili oportunističke infekcije, • koji su boravili ili putovali u područja s endemskom mikozom,
• For patients, who have previously taken biologic medicines to treat ulcerative colitis (such as those that block the activity of tumour necrosis factor in the body) and these medicines did not work, the doctor may decide to continue giving 10 mg twice a day. 
(poput onih koji sprječavaju aktivnost čimbenika nekroze tumora u tijelu), a ti im lijekovi nisu djelovali, liječnik može odlučiti da trebaju nastaviti s primjenom 10 mg dva puta dnevno.
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib. 
Ozbiljne i ponekad smrtonosne infekcije zbog bakterijskih, mikobakterijskih, invazivnih gljivičnih,
Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial 
Atipična mikobakterijska infekcija Infekcija citomegalovirus om
Maintenance of clinical responsed 
Održavanje kliničkog odgovorad
In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis. 
Općenito, kod reumatoidnog artritisa, manje je nuspojava zabilježeno uz primjenu lijeka XELJANZ samog.
Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily 
3. mjesec ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD Tofacitinib 5 mg dva puta dnevno
Laboratory tests 
Laboratorijski testovi Limfociti
• Physician educational material 
• Edukacijski materijali za liječnika trebaju sadržavati:
In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm occurred in 
U kontroliranim kliničkim ispitivanjima RA-a potvrđeno je smanjenje ALC-a ispod 500 stanica/mm3 u
Normalization of endoscopic appearance of the mucosac 
Normalizacija endoskopskog izgleda sluznicec
Table 4: Dose Adjustment for Hepatic Impairment Hepatic 
Tablica 4: Prilagodba doze kod oštećenja jetre Oštećenje jetre Klasifikacija
Table 17: Proportion of Patients Meeting Efficacy Endpoints at Week 52 (OCTAVE Sustain) Central Endoscopy Read 
Tablica 17: Udio bolesnika koji su ostvarili ishode djelotvornosti u 52. tjednu (ispitivanje OCTAVE Sustain)
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ. 
Ako dobijete rak dok se liječite lijekom XELJANZ, liječnik će razmotriti je li potrebno prekinuti uzimanje lijeka XELJANZ. - ako ste u velikom riziku od razvoja raka kože, liječnik Vam može preporučiti redovite kožne pretrage dok uzimate XELJANZ.
In studies of 6-, 12-, or 24-month duration, the rates of serious infections in the 5 mg twice daily and 10 mg twice daily tofacitinib plus DMARD groups were 3.6 and 3.4 patients with events per 100 patient-years, respectively, compared to 1.7 patients with events per 100 patient-years in the placebo plus DMARD group. 
U ispitivanjima u trajanju od 6, 12 ili 24 mjeseca, zabilježene su ozbiljne infekcije u stopi od 3,6 bolesnika na 100 bolesnik-godina u skupinama koje su primale 5 mg dva puta dnevno, naspram 3,4 bolesnika na 100 bolesnik-godina u skupinama koje su primale 10 mg tofacitiniba dva puta dnevno i DMARD, odnosno 1,7 bolesnika na 100 bolesnik-godina u skupini koja je primala placebo i DMARD.
Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders 
Poremećaji dišnog sustava, prsišta i sredoprsja
Tofacitinib had no effects on male fertility, sperm motility or sperm concentration. 
Tofacitinib nije imao učinaka na mušku plodnost,
Table 1: Low Absolute Lymphocyte Count Low Absolute Lymphocyte Count (ALC) (see section 4.4) 
Tablica 1:_ Nizak apsolutni broj limfocita Nizak apsolutni broj limfocita (ALC) (vidjeti dio 4.4) Laboratorijska vrijednost (broj stanica/mm3)
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 1 ili OCTAVE Induction 2) nakon 8 tjedana uzimanja 10 mg tofacitiniba dva puta dnevno bilo je dozvoljeno uključiti se u otvoreni nastavak ispitivanja (OCTAVE Open).
In the randomised 52-week Phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group. 
U randomiziranom 52-tjednom ispitivanju terapije održavanja faze 3 udio bolesnika s infekcijama bio je 35,9% (71 bolesnik) u skupini koja je primala 5 mg tofacitiniba dva puta dnevno i 39,8% (78 bolesnika) u skupini koja je primala 10 mg tofacitiniba dva puta dnevno, u odnosu na 24,2% (48 bolesnika) u skupini koja je primala placebo.
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA TABLETE OD 5 MG
b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability. 
b Neodgovarajući odgovor na najmanje 1 TNFi zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
Impact of Other Medicinal Products on PK of Tofacitinib 
Utjecaj drugih lijekova na farmakokinetiku tofacitiniba
XELJANZ may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis. 
Kada se koristi za liječenje reumatoidnog artritisa, XELJANZ se može koristiti u kombinaciji s metotreksatom ili ponekad sam.
Meningitis cryptococcal Mycobacterium avium complex infection 
Tuberkuloza središnjeg živčanog sustava Kriptokokni meningitis Infekcija kompleksom Mycobacteriu m avium
N Month 3 
N 3. mjesec
Talk to your doctor or pharmacist before taking XELJANZ: - if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired - if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system) - if you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back. 
- ako mislite da biste mogli imati infekciju ili imate simptome infekcije poput vrućice, znojenja, zimice, bolova u mišićima, kašlja, nedostatka zraka, nove pojave ili promjena u iskašljaju sluzi, gubitka tjelesne težine, tople, crvene ili bolne kože ili rana na Vašem tijelu, poteškoće ili boli prilikom gutanja, proljeva ili boli u trbuhu, žarenja prilikom mokrenja ili češćeg mokrenja od uobičajenog, osjećate se vrlo umorno - ako imate bilo koje stanje koje povećava Vašu šansu za infekciju (npr., šećernu bolest,
Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 8 by TNF Inhibitor Therapy Subgroups (OCTAVE Induction Study 1 and OCTAVE Induction Study 2, Central Endoscopy Read) OCTAVE Induction Study 1 
Udio bolesnika koji su ostvarili primarne i ključne sekundarne ishode djelotvornosti u 8. tjednu u podskupinama liječenim inhibitorom TNF-a (ispitivanja uvodnog liječenja OCTAVE Induction 1 i OCTAVE Induction 2, centralno očitani endoskopski nalazi)
Table 10: Radiographic Changes at Months 6 and 12 ORAL Scan: MTX Inadequate Responders 
Tablica 10: Radiološke promjene u 6. i 12. mjesecu ORAL Scan: Bolesnici s neodgovarajućim odgovorom na MTX Placebo + MTX N=139 Srednja vrijednost (SD)a
Significant reductions in DAS28-4(ESR) from baseline (mean improvement) of 1.8-2.0 and 1.9-2.2 were observed in patients treated with 5 mg and 10 mg twice daily doses, respectively, compared to placebo-treated patients (0.7-1.1) at month 3. 
U 3. mjesecu je zabilježeno značajno smanjenje vrijednosti DAS28(ESR) od 1,8-2,0 u bolesnika liječenih s 5 mg dva puta dnevno i 1,9-2,2 za 10 mg dva puta dnevno u odnosu na početnu vrijednost, za razliku od bolesnika koji su primali placebo (0,7-1,1).
Time of mandatory placebo rescue to tofacitinib 5 or 10 mg twice daily 
Vrijeme obaveznog prebacivanj a s placeba na tofacitinib 5 mg ili 10 mg dva puta dnevno
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations). 
Najčešće prijavljene nuspojave tijekom prva 3 mjeseca u kontroliranim kliničkim ispitivanjima bile su glavobolja, infekcije gornjeg respiratornog trakta, nazofaringitis, proljev, mučnina i hipertenzija
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). 
U kontroliranim kliničkim ispitivanjima faze 3, stope infekcija kroz 0-3 mjeseci u skupinama koje su primale tofacitinib u monoterapiji bile su 16,2% (100 bolesnika) uz dozu od 5 mg dvaput dnevno (ukupno 616 bolesnika), odnosno 17,9% (115 bolesnika) uz dozu od 10 mg dvaput dnevno (ukupno 642 bolesnika) u usporedbi s 18,9% (23 bolesnika) u skupini koja je primala placebo (ukupno 122 bolesnika).
The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%. 
u AUC-u tofacitiniba približno 27%.
System Organ Class 
Klasifikacij a organskih sustava
Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ. 
Limfomi i drugi oblici raka (poput raka pluća, dojke, kože (melanoma), prostate i gušterače)
How to store XELJANZ 
Moguće nuspojave Kako čuvati XELJANZ
This medicine is provided to you and supervised by a specialised doctor who knows how to treat your condition. 
Kako uzimati XELJANZ Liječnik specijalist koji zna kako liječiti Vaše stanje će Vam propisivati ovaj lijek i pratiti Vaše liječenje.
Possible side effects 
Moguće ozbiljne nuspojave
Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post marketing reports. 
U bolesnika koji su uzimali tofacitinib u kliničkim ispitivanjima i postmarketinškim izvješćima zabilježena je plućna embolija (PE).
• The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these 
o Detalje o tome kako miminizirati sigurnosna pitanja adresirana u dodatnim mjerama minimizacije rizika kroz odgovarajuće praćenje i upravljanje (tj. što uraditi, što ne uraditi i tko će najvjerojatnije biti pogođen sukladno različitom tijeku događanja, npr. kada treba ograničiti ili prekinuti propisivanje/ingestiju, kako uzimati lijek, kako povisiti/sniziti dozu prema laboratorijskim parametrima, znakovima i simptomima)
NA ORAL Scan: MTX Inadequate Responders 
ORAL Scan: Bolesnici s neodgovarajućim odgovorom na MTX
The most common serious infections included pneumonia, herpes zoster, urinary tract infection, cellulitis, gastroenteritis and diverticulitis. 
herpes zoster, infekciju urinarnog trakta, celulitis, gastroenteritis i divertikulitis.
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3. 
Ne preporučuje se započeti liječenje tofacitinibom u bolesnika čiji je ABN manji od 1000 stanica/mm3.
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. 
Remisija je bila definirana kao klinička remisija (ukupni Mayo rezultat ≤ 2 bez pojedinačnog podrezultata > 1) i podrezultat rektalnog krvarenja koji iznosi 0.
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. 
f. N = 59 za placebo, N = 65 za 5 mg tofacitiniba dva puta dnevno, N = 55 za 10 mg tofacitiniba dva puta dnevno.
QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70% 
N=broj analiziranih ispitanika, ACR20/50/70= ACR odgovor ≥ 20, 50, 70% poboljšanja, NP=nije primjenjivo,
Tofacitinib 5 mg Twice Daily + DMARD(s) 
Tofacitinib 5 mg dva puta dnevno + DMARD(ovi)
OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain 
Ispitivanje uvodnog liječenja OCTAVE Induction 2
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI ZA TABLETE OD 10 MG
a SD = Standard Deviation b Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval) c Month 6 and month 12 data are mean change from baseline d Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval) 
6. mjesec 12. mjesec a SD = standardna devijacija b Razlika tofacitinib minus placebo dobivena metodom najmanjih kvadrata (95% CI = 95%-tni interval pouzdanosti)
TNFi Inadequate Responders b 
TNFi Bolesnici s neadekvatnim odgovoromb
Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1. 
Mayo rezultata u ispitivanju uvodnog liječenja (OCTAVE Induction 1, OCTAVE Induction 2) za ≥ 3 boda i ≥ 30% uz popratno smanjenje podrezultata rektalnog krvarenja za ≥ 1 bod ili podrezultat rektalnog krvarenja 0 ili 1.
XELJANZ is a medicine that contains the active substance tofacitinib. 
Što je XELJANZ i za što se koristi XELJANZ je lijek koji sadrži djelatnu tvar tofacitinib.
Tofacitinib 10 mg Twice Daily Placebo 
Tofacitinib 10 mg dva puta dnevno Placebo
ACR20 Month 3 Month 6 Month 12 
ACR20 3. mjesec 6. mjesec 12. mjesec
ACR70 Month 3 
ACR70 3. mjesec 6. mjesec
In the subgroup of patients with prior TNF inhibitor failure, the observed treatment difference from placebo was numerically greater for tofacitinib 10 mg twice daily than tofacitinib 5 mg twice daily by 9.7 to 16.7 percentage points across the primary and key secondary endpoints. 
Razlika u liječenju u odnosu na placebo, opažena u podskupini bolesnika s prethodno neuspješnim liječenjem inhibitorom TNF-a, bila je brojčano veća za 10 mg tofacitiniba primijenjenog dva puta dnevno od one za 5 mg tofacitiniba primijenjenog dva puta dnevno za 9,7 do
≥1/10,000 to 
Rijetko ≥ 1/10 000 i
Patients receiving tofacitinib 5 mg twice daily demonstrated a greater improvement in arthritis pain (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05). 
U ispitivanjima OPAL BROADEN i OPAL BEYOND, u bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno uočeno je veće poboljšanje u odnosu na početne vrijednosti s obzirom na bol uzrokovanu artritisom (izmjereno vizualno-analognom ljestvicom od 0 do 100) u 2. tjednu (prva procjena nakon početka terapije) te do 3. mjeseca, nego u bolesnika koji su primali placebo (nominalni p ≤ 0,05).
A controlled study was conducted in patients with RA on background MTX immunised with a live attenuated virus vaccine (Zostavax®) 2 to 3 weeks before initiating a 12-week treatment with tofacitinib 5 mg twice daily or placebo. 
Kontrolirano ispitivanje provedeno je u bolesnika s RA uz osnovno liječenje MTX-om, cijepljenih živim atenuiranim virusnim cjepivom (Zostavax®) 2 do 3 tjedna prije početka 12-tjednog liječenja s
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC 
Tablica 14: Klinička ispitivanja faze 3 tofacitiniba u dozi od 5 mg i 10 mg dva puta dnevno u bolesnika s ulceroznim kolitisom Ispitivanje uvodnog liječenja OCTAVE
Time to Treatment Failure in Maintenance Study OCTAVE Sustain (Kaplan-Meier Curves) 
Slika 2. Vrijeme do neuspjeha liječenja u ispitivanju terapije održavanja OCTAVE Sustain
Maintenance (OCTAVE Sustain) 
OCTAVE Sustain.
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in physical functioning compared to placebo at month 3 (studies ORAL Solo, ORAL Sync, ORAL Standard, and ORAL Step) and month 6 (studies ORAL Sync and ORAL Standard). 
U bolesnika koji su primali tofacitinib u dozi od 5 mg ili 10 mg dva puta dnevno, poboljšanje fizičkih funkcija u 3. mjesecu u odnosu na početne vrijednosti bilo je značajno veće u usporedbi s onim u bolesnika koji su primali placebo (ispitivanja ORAL Solo, ORAL Sync, ORAL Standard i ORAL Step) i u 6. mjesecu (ispitivanja ORAL Sync i ORAL
ACR50 Month 3 Month 6 
ACR50 3. mjesec 6. mjesec
croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide 
Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2.), umrežena karmelozanatrij, magnezijev stearat, hipromeloza 6cP (E464), titanijev dioksid (E171),
ORAL Strategy: MTX Inadequate Responders 
ORAL Strategy: Bolesnici s neodgovarajućim odgovorom na MTX
Over the course of ORAL Strategy, responses with tofacitinib 5 mg twice daily + MTX were numerically similar compared to adalimumab 40 mg + MTX and both were numerically higher than tofacitinib 5 mg twice daily. 
MTX bili su brojčano slični odgovorima na primjenu adalimumaba u dozi od 40 mg + MTX i u oba navedena slučaja brojčano veći od odgovora na primjenu tofacitiniba u dozi od 5 mg dva puta dnevno.
1.3% of patients and for ALC between 500 and 750 cells/mm3 in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined. 
0,3% bolesnika, odnosno ALC između 500 i 750 stanica/mm3 u 1,9% bolesnika, sveukupno za bolesnike liječene s 5 mg dva puta dnevno i 10 mg dva puta dnevno.
The percentages of tofacitinib-treated patients achieving ACR20, ACR50 and ACR70 responses in studies ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start, and ORAL Strategy are shown in Table 8. 
Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start i ORAL Strategy ispitivanjima prikazani su u Tablici 8.
AUC Cmax 
Cmax
After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission. 
8 tjedana uzimanja 10 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Open, 53% (154/293)
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. 
Bolesnici liječeni tofacitinibom 5 mg ili 10 mg dva puta dnevno pokazali su značajno veće poboljšanje fizičkih funkcija u usporedbi s onima koji su primali placebo već u 2. tjednu u ispitivanjima ORAL Solo i ORAL Sync.
Don't take XELJANZ 10 mg twice daily if you have any of the following conditions: - Are taking combined hormonal contraceptives or hormone replacement therapy - Have heart failure (when the heart does not work as well as it should) - Have had blood clots in the veins - Have cancer - Will have or have recently had major surgery 
Uzimate kombinirane hormonske kontraceptive ili hormonsku nadomjesnu terapiju Imate zatajenje srca (kada srce ne radi kako treba)
Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a 
Tofacitinib 10 mg dva puta dnevno N=368 Srednja vrijednost (SD)a
Tofacitinib 10 mg Twice Daily N=476 
Tofacitinib 10 mg dva puta dnevno N = 476