natgillin/translations-raw huggingface dataset:
In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Breast Cancer Resistance Protein, BCRP), OATP1B1/1B3 ili OCT1/2, te nije inhibitor MDR1, OATP1B1/1B3, OCT2, OAT1/3 ili MRP pri klinički relevantnim koncentracijama.
XELJANZ 5 mg film-coated tablet contains approximately 59 mg lactose in each tablet and XELJANZ 10 mg film-coated tablet contains approximately 119 mg lactose in each tablet.
XELJANZ 5 mg filmom obložene tablete sadrže približno 59 mg laktoze u jednoj tableti, a XELJANZ 10 mg filmom obložene tablete sadrže približno 119 mg laktoze u jednoj tableti.
Population DMARD-IR DMARDIR
Populacija DMARDIR
Placebo Placebo Placebo Placebo Placebo MTX
Kontrola Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA
Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
niti induktor CYP enzima (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4) i nije inhibitor UGT enzima (UGT1A1, UGT1A4, UGT1A6, UGT1A9 i UGT2B7).
Tofacitinib was secreted in milk of lactating rats at concentrations approximately 2-fold those in serum from 1 to 8 hours postdose.
Tofacitib se izlučivao u mlijeko liječenih ženki štakora u koncentracijama približno dva puta većima od onih u serumu od 1 do 8 sati nakon doze.
• Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
• bolesnika u kojih je apsolutni broj limfocita manji od 1000 stanica/mm3 (vidjeti dio 4.2)
Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
Bolesnici liječeni tofacitinibom, koji su Japanci ili Korejci, bolesnici s dugotrajnim RA koji su prethodno primili dva ili više bioloških DMARD-ova, bolesnici u kojih je apsolutni broj limfocita manji od 1000 stanica/mm3 ili bolesnici liječeni s 10 mg dva puta dnevno mogu biti u većem riziku od herpes zostera (vidjeti dio 4.4).
Combined use of Tofacitinib with Ciclosporine should be avoided
Kombiniranu primjenu tofacitiniba s ciklosporinom treba izbjegavati
Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
e Postignuta statistička značajnost unutar ACR-ovih kategorija (ACR50 i ACR70) pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
g. N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
N = 101 za placebo, N = 101 za 5 mg tofacitiniba dva puta dnevno, N = 87 za 10 mg tofacitiniba dva puta dnevno.
Haemoglobin should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Hemoglobin treba nadzirati na početku liječenja, nakon 4 do 8 tjedana liječenja te nakon toga svaka 3
If live zoster vaccine is administered; it should only be administered to patients with a known history of chickenpox or those that are seropositive for varicella zoster virus (VZV).
Ako se primjenjuje živo cjepivo protiv herpes zostera, treba ga primijeniti samo u bolesnika s poznatom anamnezom preboljenih vodenih kozica ili u onih koji su seropozitivni na virus varicelle zoster (VZV).
Changes in total serum IgG, IgM, and IgA levels over 6-month tofacitinib dosing in patients with RA were small, not dose-dependent and similar to those seen on placebo, indicating a lack of systemic humoral suppression.
Promjene u ukupnim serumskim razinama IgG, IgM i IgA tijekom 6-mjesečnog doziranja tofacitiniba u bolesnika s RA bile su male, nisu bile ovisne o dozi i bile su slične onima nađenim uz placebo,
No Dose Adjustment
Nema prilagodbe doze
The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Djelotvornost i sigurnost primjene tofacitiniba procijenjeni su u 2 randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze 3 provedena u odraslih bolesnika s aktivnim PsA-om (≥ 3
≥1/1,000 to
≥ 1/1000 i
Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Tofacitinib u tom smislu nije ispitivan i treba izbjegavati njegovu upotrebu u kombinaciji s biološkim lijekovima poput antagonista TNF, antagonista interleukina (IL)-1R, antagonista IL-6R, monoklonskih protutijela anti-CD20, antagonista IL-17, antagonista IL-12/IL-23, anti-integrina, selektivnih modulatora kostimulacije i potentnih imunosupresiva poput azatioprina, 6-merkaptopurina,
Gastritis Dyspepsia
Gastritis Dispepsija
In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
U ispitivanju OPAL BROADEN nije bilo dozvoljeno prethodno liječenje inhibitorom
mTSS=modified Total Sharp Score, ACR20(70)=American College of Rheumatology ≥20% (≥70%) improvement,
mTSS=skor na modificiranoj Sharpovoj bodovnoj skali, ACR20(70)= ACR odgovor ≥ 20% (≥ 70%)
Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Trajnost učinka procijenjena pomoću stopa odgovora prema kriterijima ACR 20, 50 i 70 u ispitivanjima koja su trajala do dvije godine.
Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Pneumonija uzrokovana Pneumocystis jirovecii Pneumokokna pneumonija Bakterijska pneumonija Encefalitis
The overall incidence rate of infections with tofacitinib in the long-term safety all exposure population (total 4,867 patients) was 46.1 patients with events per 100 patient-years (43.8 and 47.2 patients with events for 5 mg and 10 mg twice daily, respectively).
Ukupna stopa incidencije infekcija uz tofacitinib u ispitivanju dugoročne sigurnosti za cjelokupnu izloženost populacije (ukupno 4867 bolesnika) bila je 46,1 bolesnik s događajem na 100 bolesnikgodina (43,8 odnosno 47,2 bolesnika s događajem za 5 mg i 10 mg dva puta dnevno).
The MAH shall ensure that in each Member State where XELJANZ is marketed, all healthcare professionals and patients/carers who are expected to prescribe or use XELJANZ have access to/are provided with the following educational package:
• Nositelj odobrenja mora osigurati da su svim zdravstvenim radnicima i bolesnicima/skrbnicima od kojih se očekuje propisivanje ili primjena lijeka XELJANZ u svim zemljama članicama u kojima je XELJANZ stavljen u promet, dostupni sljedeći paket edukacijskih materijala:edukacijski materijali za liječnike
There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Nije bilo dokaza odnosa između ozbiljnih ili oportunističkih infekcija ili herpesa zostera i broja limfocita u podskupinama (vidjeti dio
In all studies, patients treated with either 5 or 10 mg twice daily tofacitinib had statistically significant ACR20, ACR50 and ACR70 response rates at month 3 and month 6 versus placebo (or versus MTX in ORAL Start) treated patients.
U svim ispitivanjima bolesnici liječeni bilo s 5 mg ili 10 mg tofacitiniba dnevno imali su statistički značajne ACR20, ACR50 i ACR70 stope odgovora u 3. i 6. mjesecu u odnosu na bolesnike koji su primali placebo (ili u odnosu na MTX u ispitivanju Oral Start).
Month 3 Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
3. mjesec 6. mjesec (ispitanici koji su primali placebo i imali <20% poboljšanja u broju otečenih i bolnih zglobova prebačeni su na tofacitinib u 3.
Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
Istodobna primjena ketokonazola (snažni inhibitor CYP3A4), flukonazola (umjereni CYP3A4 i snažni inhibitor CYP2C19), takrolimusa (blagi inhibitor CYP3A4) i ciklosporina (umjereni inhibitor CYP3A4) povećala je AUC tofacitiniba, dok je rifampicin (snažni CYP induktor) smanjio AUC tofacitiniba.
Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Tobacitinib se izlučivao u mlijeko liječenih ženki štakora (vidjeti dio 5.3).
* p<0.0001; † p<0.001; ‡ p<0.05.
Klinički odgovord * p < 0,0001; † p < 0,001; ‡ p < 0,05.
NMSCs have been reported in patients treated with tofacitinib.
NMSC su prijavljeni u bolesnika liječenih tofacitinibom.
The proportion of patients in both tofacitinib groups who had treatment failure was lower compared to placebo at each time point as early as week 8, the first time point where treatment failure was assessed, as shown in Figure 2.
Udio bolesnika s neuspješnim liječenjem u obje skupine liječene tofacitinibom bio je manji u usporedbi s placebom u svakoj vremenskoj točki već od 8. tjedna, a to je bila prva vremenska točka u kojoj je liječenje procijenjeno kao neuspješno, kako je prikazano na slici 2.
• The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening of the patient o Vaccination course to be completed before treatment o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
o Liste testova koje treba provesti tijekom inicijalnog probira bolesnika o Shemu cijepljenja koja mora biti dovršena prije početka liječenja o Odgovarajuće komorbiditete uz koje se savjetuje oprez kod primjene lijeka XELJANZ i stanja u kojima se XELJANZ ne smije primijeniti o Listu konkomitantnih lijekova koji nisu kompatibilni s liječenjem lijekom XELJANZ o Potrebu rasprave s bolesnikom o rizicima povezanim s primjenom lijeka XELJANZ, osobito u pogledu infekcija, herpes zostera, tuberkuloze (TBC) i drugih oportunističkih infekcija, maligniteta, gastrointestinalne perforacije, intersticijske bolesti pluća i poremećaja u vrijednostima laboratorijskih testova o Potrebu praćenja bilo kakvih znakova i simptoma te poremećaja vrijednosti laboratorijskih testova za ranu identifikaciju gore navedenih rizika.
- The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Drugi sastojci su mikrokristalična celuloza, laktoza hidrat (pogledajte dio 2.), umrežena karmelozanatrij, magnezijev stearat, hipromeloza 6cP (E464), titanijev dioksid (E171), makrogol 3350, triacetin (E1518), bojila FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) i FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
Izloženost tofacitinibu je smanjena uz istodobnu primjenu sa snažnim CYP induktorima (npr.
Combined use of Tofacitinib with Tacrolimus should be avoided
Kombiniranu primjenu tofacitiniba s takrolimusom treba izbjegavati
The risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily.
Rizik od NMSC-a može biti veći u bolesnika liječenih s 10 mg tofacitiniba dva puta dnevno nego u bolesnika liječenih s 5 mg dva puta dnevno.
As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section
Kao mjera opreza, primjena tofacitiniba tijekom trudnoće je kontraindicirana (vidjeti dio 4.3).
• Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
• Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. • Aktivna tuberkuloza (TBC), ozbiljne infekcije poput sepse ili oportunističkih infekcija (vidjeti dio 4.4).
Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
Povišene vrijednosti transaminaza Abnormalne vrijednosti testova jetrene funkcije Povišena vrijednost gamaglutamil transferaze Povišena vrijednost kreatinina u krvi
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
4.2 Doziranje i način primjene Liječenje treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju stanja za koja je tofacitinib indiciran.
Table 5: Dose Adjustment for Renal Impairment Renal
Tablica 5: Prilagodba doze kod oštećenja bubrega Oštećenje bubrega
XELJANZ 10 mg film-coated tablet is blue and round in appearance.
XELJANZ 10 mg filmom obložena tableta je plave boje i okruglog izgleda.
OCTAVE Induction Study 2 Central Endoscopy Read
Ispitivanje uvodnog liječenja OCTAVE Induction 2 Centralno očitani endoskopski nalazi
c. Normalization of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
c. Normalizacija endoskopskog izgleda sluznice bila je definirana kao Mayo endoskopski podrezultat koji iznosi 0.
ORAL Step: TNF Inhibitor Inadequate Responders N=118
N=188 ORAL Step: Bolesnici s neodgovarajućim odgovorom na TNF inhibitore N=118
NA ORAL Sync: DMARD Inadequate Responders
ORAL Sync: Bolesnici s neodgovarajućim odgovorom na DMARD
In patients treated with tofacitinib, the incidence of herpes zoster appears to be increased in:
Čini se da je u bolesnika liječenih tofacitinibom rizik od herpesa zostera veći u:
In post-marketing experience, cases of drug hypersensitivity associated with tofacitinib administration have been reported.
U razdoblju nakon stavljanja lijeka u promet prijavljeni su slučajevi preosjetljivosti na lijek povezani s primjenom tofacitiniba.
Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Tuberkuloza Divertikulitis Pijelonefritis Celulitis Herpes simplex Virusni gastroenteritis Virusna infekcija
c. Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
modified Total Sharp Score); postotak ispitanika koji su postigli ACR20 ili ACR70 odgovore; srednja promjena u odnosu na početne vrijednosti u HAQ-DI; postotak ispitanika koji postižu DAS28-4(ESR) < 2,6 (remisija).
c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
c Globalno postignuta statistička značajnost pri p ≤ 0,05 po unaprijed određenom step-down postupku testiranja.
After 8 weeks on tofacitinib 10 mg twice daily in OCTAVE Open, remission was achieved in 35% (20/58) patients who received tofacitinib 5 mg twice daily in OCTAVE Sustain and 40% (40/99) patients with dose interruption in OCTAVE Sustain.
Nakon što su 8 tjedana primali 10 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Open, remisiju je postiglo 35 % (20/58) bolesnika koji su primali 5 mg tofacitiniba dva puta dnevno u ispitivanju OCTAVE Sustain i 40 % (40/99) bolesnika čija je doza lijeka bila ukinuta u ispitivanju
Local Endoscopy Read
Lokalno očitani endoskopski nalazi
*Spontaneous reporting data
*Podaci iz spontanog prijavljivanja Opis odabranih nuspojava
Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
kriptokokna infekcija, histoplazmoza, ezofaringealna kandidijaza, multidermatomski herpes zoster, citomegalovirus, infekcija BK virusom i listerioza bile su prijavljene uz tofacitinib.
The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
Ulcerozni kolitis Najčešće nuspojave prijavljene u bolesnika koji su primali 10 mg tofacitiniba dva puta dnevno u ispitivanjima uvodnog liječenja bile su glavobolja, nazofaringitis, mučnina i artralgija.
c. 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).
Poboljšanje endoskopskog izgleda sluznice bilo je definirano kao Mayo endoskopski podrezultat 0 (normalna ili neaktivna bolest) ili 1 (eritem, smanjen vaskularni uzorak).
Note: Reference group is administration of tofacitinib alone.
*CI = interval pouzdanosti Napomena: Referentna skupina je primjena samo tofacitiniba.
INFORMATION IN BRAILLE XELJANZ 10 mg
16. PODACI NA BRAILLEOVOM PISMU XELJANZ 10 mg
• The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals o Prescriber checklist o Patient alert card o A reference to the website with the educational material and patient alert card
o Sažetak opisa svojstava lijeka o Vodič za zdravstvene radnike o Kontrolnu listu za propisivača o Karticu s upozorenjima za bolesnika o Referencu na internetsku stranicu s edukacijskim materijalima i karticom s upozorenjima za bolesnika
What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
Kako XELJANZ izgleda i sadržaj pakiranja XELJANZ 5 mg filmom obložena tableta je bijele boje i okruglog izgleda.
For recommended modifications based on haemoglobin level, see section 4.2.
Za preporučene izmjene na temelju razine hemoglobina vidjeti dio 4.2.
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 or 10 mg twice daily respectively, both significant versus MTX.
U skupini koja je primala MTX, u 70% bolesnika radiološki nalaz nije pokazao progresiju u 6. mjesecu u usporedbi s 83% odnosno 90% bolesnika liječenih s 5 mg ili 10 mg tofacitiniba dva puta dnevno, oboje signifikantno naspram MTX.
Lymphoma was observed in 3 of 8 adult monkeys at 6 or 3 times the clinical tofacitinib exposure level (unbound AUC in humans at a dose of 5 mg or 10 mg twice daily), and 0 of 14 juvenile monkeys at 5 or 2.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Limfom je nađen kod 3 od 8 odraslih majmuna pri razini izloženosti tofacitinibu 6 ili 3 puta većoj od kliničkih (AUC za nevezani lijek u ljudi uz dozu od 5 mg ili 10 mg dvaput dnevno) te kod 0 od 14 mladih majmuna uz razinu izloženosti 5 ili 2,5 puta veću od razine izloženosti uz dozu od 5 mg ili
Remission among patients in remission at baselinea,f
Remisija među bolesnicima u remisiji prije početka terapijea,f
Prior TNFi failure Prior corticosteroid failure
TNF-a Prethodno neuspješno liječenje kortikosteroidima
As early as week 2, the earliest scheduled study visit, and at each visit thereafter, significant differences were observed between tofacitinib 10 mg twice daily and placebo in the change from baseline in rectal bleeding and stool frequency, and partial Mayo score.
Već u 2. tjednu, kada je bio zakazan najraniji posjet u sklopu ispitivanja, i pri svakom kasnijem posjetu bile su opažene značajne razlike između primjene 10 mg tofacitiniba dva puta dnevno i placeba u promjeni od početne vrijednosti za rektalno krvarenje i učestalosti stolice te parcijalnom
If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Ponovno liječenje ulceroznog kolitisa Ako dođe do privremenog prekida terapije, može se razmotriti ponovno liječenje tofacitinibom.
The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
PsA-om i UC-om te su prikazane prema klasifikaciji organskih sustava i kategorijama učestalosti koje su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patientyears, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
U skupini koja je primala tofacitinib u monoterapiji u dozi od 10 mg dva puta dnevno stopa je bila 1,6 bolesnika s događajem na 100 bolesnik-godina, za placebo je stopa bila 0 događaja na 100 bolesnik-godina, a za skupinu koja je primala MTX stopa je bila 1,9 bolesnika s događajem na 100 bolesnik-godina.
Liver enzyme tests
Testovi jetrenih enzima
For recommended modifications based on ANC, see section 4.2.
Za preporučene izmjene na temelju ABN vidjeti dio 4.2.
Table 12: Proportion (%) of PsA Patients Who Achieved Clinical Response and Mean Change from Baseline in OPAL BROADEN and OPAL BEYOND Studies Conventional Synthetic DMARD Inadequate Responders a
Tablica 12: Udio (%) bolesnika s PsA-om koji su postigli klinički odgovor i srednju vrijednost promjene u odnosu na početnu vrijednost u ispitivanjima OPAL BROADEN i OPAL BEYOND
INFORMATION IN BRAILLE XELJANZ 5 mg
16. PODACI NA BRAILLEOVOM PISMU XELJANZ 5 mg
Keep this medicine out of the sight and reach of children.
Kako čuvati XELJANZ Lijek čuvajte izvan pogleda i dohvata djece.
Inadequate response to at least one conventional synthetic DMARD (csDMARD) due to lack of efficacy and/or intolerability.
a Neadekvatan odgovor na najmanje jedan konvencionalni sintetski DMARD (csDMARD) zbog izostanka djelotvornosti i/ili zbog nepodnošenja.
Dose Adjustment
Prilagodba doze
• hives (itching or skin rash)
• koprivnjača (svrbež ili osip na koži)
If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Ako se vodene kozice ne mogu sa sigurnošću potvrditi iz povijesti bolesti, preporučuje se napraviti test na protutijela protiv VZV.
Treatment Group
Liječena skupina
PASI75g Month 3
PASI75g 3. mjesec 6. mjesec 12. mjesec
Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Održana remisija bez kortikosteroida u 24. i 52. tjednu među bolesnicima u remisiji prije početka terapijed