natgillin/translations-raw huggingface dataset:
The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.
Najpogostejši okužbi, zaradi katerih so prekinili zdravljenje, sta bili herpes zoster in pljučnica.
Take your next 11 mg prolonged-release tablet at the usual time and continue as before.
Naslednjo 11 mg tableto s podaljšanim sproščanjem vzemite ob običajnem času in nadaljujte z jemanjem kot običajno.
• who have resided or travelled in areas of endemic mycoses,
• ki so bivali na območjih z endemičnimi mikozami ali so tja potovali,
The clinical significance of this is unknown, however, similar results were obtained in a separate vaccine study with influenza and pneumococcal polysaccharide vaccines in patients receiving long-term tofacitinib 10 mg twice daily.
Klinični pomen tega ni znan, vendar so podobne rezultate dobili tudi v drugem preskušanju s cepivi, v katerem so uporabili cepivo proti gripi in polisaharidno cepivo proti pnevmokokom pri bolnikih, ki so dolgotrajno prejemali 10 mg tofacitiniba dvakrat na dan.
Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
Resne okužbe so lahko pogostejše pri ljudeh, ki jemljejo tudi kortikosteroide (npr. prednizon).
What you need to know before you take XELJANZ
Kaj morate vedeti, preden boste vzeli zdravilo XELJANZ
All metabolites have been observed in animal species and are predicted to have less than 10-fold potency than tofacitinib for JAK1/3 inhibition.
Vse presnovke so opazili pri živalskih vrstah in predvidevajo, da imajo manj kot 10-kratno jakost zaviranja kinaz JAK1/3 kot tofacitinib.
In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
V nekliničnih preskušanjih so opazili učinke na imunski in hematopoetski sistem, ki so jih pripisali farmakološkim značilnostim (zaviranje encimov JAK) tofacitiniba.
Changes in CRP observed with tofacitinib treatment do not reverse fully within 2 weeks after discontinuation, indicating a longer duration of pharmacodynamic activity compared to the half-life.
Spremembe vrednosti CRP, ki so jih opazili pri zdravljenju s tofacitinibom, se v 2 tednih po prekinitvi zdravljenja niso v celoti povrnile na izhodiščne vrednosti, kar kaže na daljše trajanje farmakodinamične aktivnosti v primerjavi z razpolovnim časom.
The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Tofacitinib se presnavlja predvsem preko encima CYP3A4, z manjšim prispevkom encima CYP2C19.
In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
Tofacitiniba v kliničnih preskušanjih niso ocenjevali pri bolnikih z očistkom kreatinina (ocenjenim po CockcroftGaultovi enačbi), manjšim od 40 ml/min (glejte poglavje 4.2).
Antituberculosis therapy should also be considered prior to administration of tofacitinib in patients who test negative for TB but who have a past history of latent or active TB and where an adequate course of treatment cannot be confirmed; or those who test negative but who have risk factors for TB infection.
Pred uporabo tofacitiniba je treba pretehtati tudi možnost zdravljenja TB pri bolnikih z negativnim testom na TB, ki imajo latentno ali aktivno TB v anamnezi in pri katerih ni mogoče potrditi ustreznega poteka zdravljenja; ali pri katerih je bil test negativen, vendar imajo dejavnike tveganja za okužbo s TB.
The use of tofacitinib in combination with phosphodiesterase 4 inhibitors has not been studied in tofacitinib clinical studies.
Uporabe tofacitiniba v kombinaciji z zaviralci fosfodiesteraze tipa 4 v kliničnih preskušanjih tofacitiniba niso preučevali.
In the RA long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical studies (see section 4.4).
V populaciji z RA, pri kateri so preučevali dolgoročno varnost, sta vzorec in incidenca potrjenega zmanjšanja ANC ostala skladna z opažanji v nadzorovanih kliničnih preskušanjih (glejte poglavje 4.4).
An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Opazili so približno linearno povezavo med telesno maso in volumnom porazdelitve, kar je pri bolnikih z manjšo telesno maso povzročilo večjo največjo (Cmax) in nižjo najnižjo (Cmin) koncentracijo.
Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Statistično značilnost znotraj družine ACR (ACR50 in ACR70) so dosegli pri p ≤ 0,05 po vnaprej določenem postopku testiranja s postopno regresijo.
Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of gastrointestinal perforation.
Bolnike, pri katerih se na novo pojavijo trebušni znaki in simptomi, je treba takoj pregledati za zgodnje odkrivanje perforacije prebavil.
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
- če imate veliko tveganje za pojav kožnega raka, vam bo zdravnik morda svetoval, naj vam med jemanjem zdravila XELJANZ opravljajo redne preglede kože.
Pharmacokinetics in patients
Farmakokinetika pri bolnikih
Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose.
Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 59,44 mg laktoze.
The efficacy and safety of tofacitinib were assessed in 6 randomised, double-blind, controlled multicentre studies in patients greater than 18 years of age with active RA diagnosed according to American College of Rheumatology (ACR) criteria.
Učinkovitost in varnost tofacitiniba so ocenili v 6 randomiziranih, dvojno slepih, nadzorovanih, multicentričnih preskušanjih pri bolnikih, starejših od 18 let, z aktivnim RA, diagnosticiranim po merilih Ameriške akademije za revmatologijo (ACR - American College of Rheumatology).
The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases in systemic exposure.
Za farmakokinetični profil tofacitiniba so značilni hitra absorpcija (največje koncentracije v plazmi doseže v 0,5-1 uri), hitro izločanje (razpolovni čas je približno 3 ure) in odmerku sorazmerna zvečanja sistemske izpostavljenosti.
For some patients, such as those who have failed prior tumour necrosis factor (TNF) antagonist therapy, consideration should be given to continuation of the 10 mg twice daily dose for maintenance in order to maintain therapeutic benefit (see section 5.1).
Pri nekaterih bolnikih, kot so tisti, pri katerih je bilo predhodno zdravljenje z antagonistom tumorje nekrotizirajočega faktorja (TNF) neučinkovito, je treba razmisliti o nadaljnji uporabi odmerka 10 mg dvakrat na dan za vzdrževalno zdravljenje, da bi ohranili korist zdravljenja (glejte poglavje 5.1).
The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Razpoložljivi podatki so pokazali tudi, da med belopoltimi, temnopoltimi in azijskimi bolniki ni večjih razlik v vrednosti AUC tofacitiniba.
If taken with XELJANZ, they could alter the level of XELJANZ in your body, and the dose of XELJANZ may require adjustment.
Če jih jemljete skupaj z zdravilom XELJANZ, lahko spremenijo raven zdravila XELJANZ v telesu, zato bo odmerek zdravila XELJANZ morda treba prilagoditi.
Time to treatment failure in maintenance study OCTAVE sustain (Kaplan-Meier Curves)
Čas do prenehanja učinkovitosti zdravljenja v preskušanju vzdrževalnega zdravljenja OCTAVE Sustain (Kaplan-Meierjeve krivulje)
Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Pri bolnikih z zvečanim tveganjem za kožnega raka je priporočljivo redno pregledovanje kože (glejte preglednico 6 v poglavju 4.8).
Try to take your tablet (one 11 mg prolonged-release tablet) at the same time each day, e.g., morning or evening.
Tableto (eno 11 mg tableto s podaljšanim sproščanjem) poskusite vzeti vsak dan ob isti uri, tj. zjutraj ali zvečer.
Abbreviations: TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis.
Okrajšave: TNFi = zaviralec tumorje nekrotizirajočega faktorja (Tumour Necrosis Factor inhibitor); UK = ulcerozni kolitis.
Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
Do predrtja v želodcu ali črevesju najpogosteje pride pri ljudeh, ki jemljejo tudi nesteroidna protivnetna zdravila ali kortikosteroide (npr. prednizon).
Signs of allergic reactions (unknown) include
Znaki alergijskih reakcij (neznana pogostnost) vključujejo:
The primary endpoint in OCTAVE Sustain was the proportion of patients in remission at week 52.
Primarni opazovani dogodek v preskušanju OCTAVE Sustain je bil delež bolnikov, ki so bili po 52 tednih v remisiji.
Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to > 1 biological DMARD.
V preskušanju PsA-II (OPAL BEYOND) so ocenili 394 bolnikov, ki so prekinili zdravljenje z antagonistom TNF zaradi nezadostne učinkovitosti ali intolerance; 36,0 % se jih je predhodno nezadostno odzvalo na > 1 biološko DMARD.
Asian RA patients are known to be at higher risk of interstitial lung disease, thus caution should be exercised in treating these patients.
Tveganje za intersticijsko pljučno bolezen je večje pri bolnikih azijske rase z RA, zato je pri zdravljenju teh bolnikov potrebna previdnost.
Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
Bolniki s hudo okvaro ledvic morajo tudi po hemodializi še naprej jemati zmanjšani odmerek (glejte poglavje 5.2).
The main objective of the programme is to increase awareness about the risks of the product, specifically in regards to serious infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities.
Glavni cilj programa je povečanje ozaveščenosti glede tveganj zdravila, še zlasti v povezavi z resnimi okužbami, herpes zostrom, tuberkulozo (TB) in drugimi oportunističnimi okužbami, malignimi boleznimi, perforacijami prebavil, intersticijsko pljučno boleznijo in nenormalnimi vrednostmi laboratorijskih preiskav.
The frequency of serious infection among tofacitinib-treated patients 65 years of age and older was higher than those under the age of 65 (4.8 per 100 patient-years versus 2.4 per 100 patient-years, respectively).
Pogostnost resnih okužb med bolniki, starimi 65 let in več, ki so prejemali tofacitinib, je bila večja kot med bolniki, mlajšimi od 65 let (4,8 na 100 bolnikov-let v primerjavi z 2,4 na 100 bolnikov-let).
XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Zdravilo XELJANZ se uporablja skupaj z metotreksatom za zdravljenje odraslih bolnikov z aktivnim psoriatičnim artritisom.
Do not take a double dose to make up for a forgotten 11 mg prolonged-release tablet.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo 11 mg tableto s podaljšanim sproščanjem.
In subjects with end-stage renal disease (ESRD), contribution of dialysis to the total clearance of tofacitinib was relatively small.
Pri preskušancih s končno ledvično odpovedjo je bil prispevek dialize k celokupnemu očistku tofacitiniba relativno majhen.
Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to > 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD).
V preskušanju PsA-I (OPAL BROADEN) so ocenili 422 bolnikov, ki so se predhodno nezadostno odzvali (zaradi nezadostne učinkovitosti ali intolerance) na csDMARD (MTX pri 92,7 % bolnikov); 32,7 % bolnikov iz tega preskušanja se je predhodno nezadostno odzvalo na > 1 csDMARD ali 1 csDMARD in tarčno sintetično DMARD (tsDMARD).
Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
V kliničnih preskušanjih so poročali o primerih perforacije prebavil, čeprav vloga zaviranja JAK v teh primerih ni znana.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo XELJANZ nima vpliva ali ima omejen vpliv na sposobnost vožnje in upravljanja strojev.
Some medicines should not be taken with XELJANZ.
Nekaterih zdravil ne smete jemati skupaj z zdravilom XELJANZ.
Tofacitinib should not be used in patients with severe hepatic impairment (see section 4.3).
Tofacitiniba se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) (10 mg strength only) FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133) (10 mg strength only)
FD&C Blue #2/indigotin (E132) (samo jakost 10 mg) FD&C Blue #1/briljantno modro FCF (E133) (samo jakost 10 mg)
In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C.
Tofacitiniba v kliničnih preskušanjih niso ocenjevali pri preskušancih s hudo (Child-Pugh C) okvaro jeter (glejte poglavji 4.2 in 4.4) ali bolnikih, pri katerih je bil presejalni test za hepatitis B ali C pozitiven.
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).
Tofacitinib ni niti zaviralec niti induktor CYP (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4), prav tako pa ni zaviralec UGT (UGT1A1, UGT1A4, UGT1A6, UGT1A9 in UGT2B7).
• who have resided or travelled in areas of endemic TB.
• ki so bivali na območjih z endemično TB ali so tja potovali.
If you take more XELJANZ than you should If you take more tablets than you should, immediately tell your doctor or pharmacist.
Če ste vzeli večji odmerek zdravila XELJANZ, kot bi smeli Če ste vzeli več tablet, kot bi smeli, nemudoma obvestite zdravnika ali farmacevta.
• unexplained changes in bowel habits
• nepojasnjene spremembe pri izločanju blata.
60 film-coated tablets 180 film-coated tablets
60 filmsko obloženih tablet 180 filmsko obloženih tablet
The impact of tofacitinib on chronic viral hepatitis reactivation is unknown.
Vpliv tofacitiniba na reaktivacijo kroničnega virusnega hepatitisa ni znan.
• Patients with an ALC less than 1,000 cells/mm
• bolnikih z ALC, manjšim od 1.000 celic/mm
* p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
* p < 0,0001; **p < 0,001; †p < 0,05 za tofacitinib v primerjavi s placebom.
• blood in the stool
• kri v blatu,
In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Tofacitinib je in vitro substrat za MDR1, ne pa tudi za beljakovino odpornosti pri raku dojke (BCRPBreast Cancer Resistance Protein), OATP1B1/1B3 ali OCT1/2.
Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Zdravljenje s tofacitinibom je bilo povezano z zvečanjem vrednosti lipidnih parametrov, kot so celokupni holesterol, lipoproteini nizke gostote (holesterol LDL) in lipoproteini visoke gostote (holesterol HDL).
Population DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTX-naïve a
DMARD-IR DMARD-IR MTX-IR MTX-IR antagonist TNF-IR
In patients with RA, treatment up to 6 months with tofacitinib was associated with dose-dependent reductions of circulating CD16/56+ natural killer (NK) cells, with estimated maximum reductions occurring at approximately 8-10 weeks after initiation of therapy.
Pri bolnikih z RA je bilo zdravljenje s tofacitinibom, ki je trajalo do 6 mesecev, povezano z od odmerka odvisnim zmanjšanjem števila naravnih celic ubijalk CD16/56+ v krvnem obtoku, pri čemer je do največjega zmanjšanja prišlo približno 8-10 tednov po začetku zdravljenja.
At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Po 12 mesecih v preskušanju OCTAVE Open je remisijo doseglo 52 % (25/48) oziroma 45 % (37/83) teh bolnikov.
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).
Neželeni učinki, o katerih so v prvih 3 mesecih v nadzorovanih kliničnih preskušanjih najpogosteje poročali, so bili glavobol, okužbe zgornjih dihal, nazofaringitis, diareja, navzea in hipertenzija (glejte preglednico 6, Neželeni učinki zdravila na podlagi trajanj vseh študij).
Tofacitinib is a potent, selective inhibitor of the JAK family.
Tofacitinib je močan selektivni zaviralec encimov iz družine JAK.
Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Poleg tega je treba pri oceni tveganja za PE za posameznega bolnika upoštevati še druge dejavnike, kot so starejša starostna skupina, debelost, kajenje in imobilizacija.
If you are not sure regarding any of the information provided above, please contact your doctor.
Če ste glede katerekoli navedene informacije negotovi, se posvetujte z zdravnikom.
Improvement in sleep was assessed using the Sleep Problems Index I and II summary scales of the Medical Outcomes Study Sleep (MOS-Sleep) measure at month 3 in all studies.
Izboljšanje spanja so v vseh preskušanjih ocenili v 3. mesecu z uporabo zbirnih lestvic indeksa težav s spanjem I in II študije zdravstvenih izidov (MOS-Sleep - Medical Outcomes Study Sleep).
Month 6: ACR50
6. mesec: ACR50
Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Potrjeno ALC, manjše od 750 celic/mm 3, je bilo povezano z zvečano incidenco resnih okužb (glejte poglavje 4.4).
56 film-coated tablets 112 film-coated tablets 182 film-coated tablets
56 filmsko obloženih tablet 112 filmsko obloženih tablet 182 filmsko obloženih tablet
In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
V preskušanju OPAL BROADEN niso dovolili predhodnega zdravljenja z antagonistom TNF.
Patients who completed 8 weeks in 1 of the induction studies and achieved clinical response were re-randomised into OCTAVE Sustain; 179 out of 593 (30.2%) patients were in remission at baseline of OCTAVE Sustain.
Bolnike, ki so dokončali 1 od 8-tedenskih preskušanj indukcijskega zdravljenja in dosegli klinični odziv, so ponovno randomizirali v preskušanje OCTAVE Sustain; 179 od 593 (30,2 %) bolnikov je bilo ob izhodišču preskušanja OCTAVE Sustain v remisiji.
If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Če zdravljenje s tofacitinibom prekinemo, lahko razmislimo o ponovni uvedbi zdravljenja z njim.
Changes from baseline in HAQ-DI in studies ORAL Standard, ORAL Step and ORAL Sync are shown in Table 11.
Spremembe HAQ-DI od izhodišča v preskušanjih ORAL Standard, ORAL Step in ORAL Sync so prikazane v preglednici 11.
Each pack contains 28 or 91 prolonged-release tablets.
Eno pakiranje vsebuje 28 ali 91 tablet s podaljšanim sproščanjem.
Tofacitinib is given orally with or without food.
Tofacitinib dajemo peroralno s hrano ali brez nje.
Taking XELJANZ with these medicines may increase your risk of side effects including infection.
Jemanje zdravila XELJANZ skupaj s temi zdravili lahko poveča tveganje za pojav neželenih učinkov, vključno z okužbo.
In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
Za razliko od zmanjšanja po kratkotrajnem odmerjanju se je mediano število naravnih celic ubijalk CD16/56+ zvečalo za 73 % glede na izhodiščno vrednost.
Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Splošno statistično značilnost so dosegli pri p ≤ 0,05 po vnaprej določenem postopku testiranja s postopno regresijo.
It is not known whether tofacitinib is secreted in human milk.
Ni znano, ali se tofacitinib izloča v materino mleko.
Lipid monitoring
Spremljanje lipidov
The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with tofacitinib monotherapy treatment groups.
Stopnje incidence in vrste resnih okužb v kliničnih preskušanjih pri bolnikih z UK so bile na splošno podobne tistim, o katerih so poročali v kliničnih preskušanjih pri bolnikih z RA v skupinah, ki so prejemale monoterapijo s tofacitinibom.
Particular consideration should be given to patients with longstanding RA who have previously received two or more biological DMARDs.
Razmisliti je treba o profilaktičnem cepljenju proti pasovcu, zlasti pri bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških DMARD.
Improvement in fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at month 3 in all studies.
Izboljšanje utrujenosti so v vseh preskušanjih ocenili v 3. mesecu s funkcijsko oceno zdravljenja kronične bolezni (FACIT-F - Functional Assessment of Chronic Illness Therapy-Fatigue).
For pneumococcal polysaccharide vaccine the number of responders was as follows: 32% in patients receiving both tofacitinib and MTX; 62% for tofacitinib monotherapy; 62% for MTX monotherapy; and 77% for placebo.
Pri polisaharidnem cepivu proti pnevmokokom je bilo število odzivnih bolnikov naslednje: 32 % pri bolnikih, ki so prejemali tofacitinib in MTX, 62 % pri bolnikih, ki so prejemali samo tofacitinib, 62 % pri bolnikih, ki so prejemali samo MTX, in 77 % pri bolnikih, ki so prejemali placebo.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Zdravljenje mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem stanj, za katera je tofacitinib indiciran.
Month 6: mT SS ACR70
6. mesec: mTSS ACR70
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.
Odstotki bolnikov zdravljenih s tofacitinibom, ki so dosegli odziv ACR20, ACR50 in ACR70 v preskušanjih ORAL Solo, ORAL Sync, ORAL Standard, ORAL Scan, ORAL Step, ORAL Start in Oral Strategy, so prikazani v preglednici 8.
If you forget to take XELJANZ
Če ste pozabili vzeti zdravilo XELJANZ
Subjects with mild (creatinine clearance 50-80 mL/min), moderate (creatinine clearance 30-49 mL/min), and severe (creatinine clearance < 30 mL/min) renal impairment had 37%, 43% and 123% higher AUC, respectively, compared to subjects with normal renal function (see section 4.2).
Pri preskušancih z blago (očistek kreatinina 50-80 ml/min), zmerno (očistek kreatinina 30-49 ml/min) in hudo okvaro ledvic (očistek kreatinina < 30 ml/min) je bila vrednost AUC za 37 %, 43 % in 123 % večja kot pri preskušancih z normalnim delovanjem ledvic (glejte poglavje 4.2).
Drug hypersensitivity* Angioedema* Urticaria*
Bolezni imunskega sistema preobčutljivost na zdravilo*, angioedem*, urtikarija*