natgillin/translations-raw huggingface dataset:
Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or red blood cell counts.
Zdravnik lahko vaše zdravljenje začasno ali trajno prekine, če rezultati krvnih preiskav pokažejo majhno število belih ali rdečih krvnih celic.
Table 8: Proportion (%) of patients with an ACR response ORAL Solo: DMARD inadequate responders
Preglednica 8: Delež (%) bolnikov z odzivom ACR ORAL Solo: bolniki z nezadostnim odzivom na DMARD
Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Bolnike je treba obravnavati skladno s kliničnimi smernicami za zdravljenje hiperlipidemije.
Signs of serious infections (common) include
Znaki resnih okužb (pogosti) vključujejo:
Your doctor should test your cholesterol levels 8 weeks after you start receiving XELJANZ.
Zdravnik mora preveriti vaše ravni holesterola 8 tednov po začetku jemanja zdravila XELJANZ.
This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body.
To je prazna ovojnica tablete s podaljšanim sproščanjem, ki ostane po absorpciji zdravila v telesu.
Health-related and quality of life outcomes
Izidi, povezani z zdravjem in kakovostjo življenja
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
Ne jemljite zdravila XELJANZ 10 mg dvakrat na dan, če imate kateregakoli od naslednjih stanj: - jemljete kombinirane hormonske kontraceptive ali nadomestno hormonsko terapijo, - imate srčno popuščanje (ko srce ne deluje tako dobro, kot bi moralo), - imate krvne strdke v venah, - imate raka, - boste imeli ali ste pred kratkim imeli večji operativni poseg.
In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Pri bolnikih z RA se peroralni očistek tofacitiniba ne spreminja s časom, kar kaže na to, da zdravljenje s tofacitinibom ne normalizira aktivnosti encimov CYP.
Patients treated with tofacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Pri bolnikih, ki se zdravijo s tofacitinibom, je treba dejavnike tveganja (npr. hipertenzijo, hiperlipidemijo) obravnavati kot del standardne oskrbe.
• with a history of a serious or an opportunistic infection,
• z resnimi ali oportunističnimi okužbami v anamnezi,
Of the 4,271 patients who enrolled in RA studies I-VI (see section 5.1), a total of 608 RA patients were 65 years of age and older, including 85 patients 75 years and older.
Od 4.271 bolnikov, ki so bili vključeni v Preskušanja I-VI pri bolnikih z RA (glejte poglavje 5.1), je bilo skupno 608 bolnikov z RA starih 65 let in več, vključno s 85 bolniki, starimi 75 let in več.
You can take XELJANZ with or without food.
Zdravilo XELJANZ lahko jemljete s hrano ali brez nje.
ALC less than 500
ALC manjše od 500
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
V primeru prevelikega odmerjanja je bolnika priporočljivo spremljati glede znakov in simptomov neželenih učinkov.
Tofacitinib has no or negligible influence on the ability to drive and use machines.
Tofacitinib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
In human cells, tofacitinib preferentially inhibits signalling by heterodimeric cytokine receptors that associate with JAK3 and/or JAK1 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
V človeških celicah tofacitinib prednostno zavira prenašanje signalov prek heterodimernih citokinskih receptorjev, povezanih z JAK3 in/ali JAK1 z večjo funkcionalno selektivnostjo kot za citokinske receptorje, ki signale prenašajo prek parov z JAK2.
• who have underlying conditions that may predispose them to infection.
• z osnovnimi stanji, ki lahko zvečajo dovzetnost za okužbe.
There are limited data in patients aged 75 years and older.
Podatki pri bolnikih, starih 75 let in več, so omejeni.
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes (see section 4.8).
Ker je incidenca okužb v populacijah starejših in diabetikov na splošno večja, je pri zdravljenju starejših bolnikov in bolnikov z diabetesom potrebna previdnost (glejte poglavje 4.8).
The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Varnost in učinkovitost tofacitiniba pri otrocih, starih od 0 do manj kot 18 let, nista bili dokazani.
Examination of age, sex, race, baseline disease activity and PsA subtype did not identify differences in response to tofacitinib.
Pri pregledu starosti, spola, rase, aktivnosti bolezni ob izhodišču in podtipa PsA niso odkrili razlik v odzivu na tofacitinib.
(see section 4.2).
3 (glejte poglavje 4.2),
Population PK analysis in RA patients indicated that systemic exposure (AUC) of tofacitinib in the extremes of body weight (40 kg, 140 kg) were similar (within 5%) to that of a 70 kg patient.
Analiza populacijske farmakokinetike pri bolnikih z RA je pokazala, da je sistemska izpostavljenost (AUC) tofacitinibu pri bolnikih z ekstremno telesno maso (40 kg, 140 kg) podobna (znotraj 5 %) kot pri bolniku s telesno maso 70 kg.
Once daily Do not swallow the desiccant.
enkrat na dan Ne zaužijte sušilnega sredstva.
Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Zdravnik vam bo morda opravil tudi druge preiskave, na primer za preverjanje ravni holesterola v krvi ali spremljanje delovanja jeter.
Following initiation, routine monitoring of liver tests and prompt investigation of the causes of any observed liver enzyme elevations are recommended to identify potential cases of drug-induced liver injury.
Po uvedbi zdravljenja sta priporočljiva rutinsko spremljanje jetrnih testov in takojšnja raziskava vzrokov kakršnegakoli opaženega zvečanja vrednosti jetrnih encimov z namenom odkrivanja morebitnih primerov z zdravilom povzročene poškodbe jeter.
The decision to use live vaccines prior to tofacitinib treatment should take into account the pre-existing immunosuppression in a given patient.
Pri odločitvi o uporabi živih cepiv pred zdravljenjem s tofacitinibom je treba upoštevati predhodno imunosupresijo pri posameznem bolniku.
Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2.
Kriteriji za prekinitev zdravljenja in spremljanje limfopenije so opisani v poglavju 4.2.
Tofacitinib had no effects on male fertility, sperm motility or sperm concentration.
Tofacitinib ni imel učinka na plodnost pri samcih, gibljivost spermijev ali koncentracijo sperme.
Improvements from baseline in SF-36v2 and FACIT-F were maintained through month 6 (OPAL BROADEN and OPAL BEYOND) and month 12 (OPAL BROADEN).
Izboljšanja ocen SF-36v2 in FACIT-F glede na izhodišče so se ohranila do 6. meseca (OPAL BROADEN in OPAL BEYOND) oziroma 12. meseca (OPAL BROADEN).
Note: Reference group is administration of tofacitinib alone.
Opomba: referenčna skupina je skupina, ki je prejemala samo tofacitinib.
Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): tuberkuloza, ki zajame možgane in hrbtenjačo, meningitis.
The tablets are provided in blisters containing 14 tablets.
Tablete so na voljo v pretisnih omotih, ki vsebujejo 14 tablet.
Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Bolniki, ki so jih randomizirali v skupino z adalimumabom (skupina z aktivno kontrolo), so 12 mesecev prejemali 40 mg subkutano vsaka 2 tedna.
Ratio relative to reference
Razmerje glede na referenčno skupino
Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Zvečanja vrednosti lipidnih parametrov (celokupni holesterol, holesterol LDL, holesterol HDL, trigliceridi) so prvič ocenili 1 mesec po začetku zdravljenja s tofacitinibom v nadzorovanih dvojno slepih kliničnih preskušanjih RA.
Patients with RA, particularly those with highly active disease may be at a higher risk (up to several-fold) than the general population for the development of lymphoma.
Pri bolnikih z RA, zlasti tistih z zelo aktivno boleznijo, je lahko tveganje za razvoj limfoma večje (tudi do nekajkrat) kot pri splošni populaciji.
Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis).
Pojavijo se lahko tudi druge resne okužbe, o katerih v kliničnih preskušanjih niso poročali (npr. kokcidioidomikoza).
Each prolonged-release tablet contains 152.23 mg of sorbitol.
Ena tableta s podaljšanim sproščanjem vsebuje 152,23 mg sorbitola.
The European Medicines Agency has deferred the obligation to submit results of studies with tofacitinib in one or more subsets of the paediatric population in juvenile idiopathic arthritis and in ulcerative colitis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s tofacitinibom za eno ali več podskupin pediatrične populacije z juvenilnim idiopatskim artritisom in z ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
ANC less than 500
ANC manjše od 500
The most common serious adverse reactions were serious infections (see section 4.4).
Najpogostejši resni neželeni učinki so bile resne okužbe (glejte poglavje 4.4).
Lab Value (g/dL)
Laboratorijska vrednost (g/dl)
Analysis of erosion and JSN scores were consistent with overall results.
Analizi ocen erozije sklepov in JSN sta bili skladni s celokupnimi rezultati.
Caution is also recommended in patients with a history of chronic lung disease as they may be more prone to infections.
Previdnost je priporočljiva tudi pri bolnikih s kroničnimi pljučnimi boleznimi v anamnezi, saj so lahko dovzetnejši za okužbe.
Other findings at doses exceeding human exposures included effects on the hepatic and gastrointestinal systems.
Druge ugotovitve pri odmerkih, ki presegajo izpostavljenost pri človeku, so vključevale učinke na jetrni in prebavni sistem.
XELJANZ may increase your risk of certain cancers.
Zdravilo XELJANZ lahko zveča tveganje za pojav nekaterih vrst raka.
Key features Monotherapy Various csDMARDs
Ključne lastnosti monoterapija različna csDMARD
Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Pomožna snov z znanim učinkom Ena filmsko obložena tableta vsebuje 118,88 mg laktoze.
Some patients have presented with disseminated rather than localised disease.
Pri nekaterih bolnikih bolezen ni bila lokalizirana, ampak razširjena.
The efficacy results based on the endoscopic readings at the study sites were consistent with the results based on the central endoscopy readings.
Rezultati učinkovitosti, ki so temeljili na pregledu endoskopskih posnetkov na mestu kliničnega preskušanja, so bili skladni z rezultati, ki so temeljili na centraliziranem pregledu endoskopskih posnetkov.
The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Najpogosteje poročane okužbe so bile okužbe zgornjih dihal (3,7 %) in nazofaringitis (3,2 %).
Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy.
Vrednosti lipidnih parametrov je treba oceniti 8 tednov po uvedbi zdravljenja s tofacitinibom.
Other side effects which have been observed with XELJANZ are listed below.
Drugi neželeni učinki, ki so jih opazili pri jemanju zdravila XELJANZ, so navedeni spodaj.
Each pack contains 56, 112, or 182 tablets and each bottle contains 60 or 180 tablets.
Eno pakiranje vsebuje 56, 112 ali 182 tablet, ena plastenka pa vsebuje 60 ali 180 tablet.
No evidence of stereo conversion in human samples was detected.
Pri človeških vzorcih niso odkrili dokazov o stereo-konverziji.
Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Tofacitinib je samostojno ali v kombinaciji z MTX pokazal izboljšanje telesne funkcije, izmerjeno z indeksom HAQ-DI.
Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila XELJANZ na trg v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
Tofacitinib was administered as monotherapy (i.e., without concomitant use of biologics and immunosuppressants) for UC.
Tofacitinib so dajali kot monoterapijo (tj. brez sočasne uporabe bioloških zdravil in imunosupresivov) za zdravljenje UK.
Before you start XELJANZ, you should be up to date with all recommended vaccinations.
Pred začetkom zdravljenja z zdravilom XELJANZ morate opraviti vsa priporočena cepljenja.
TNF=tumour necrosis factor; N=number of patients in the analysis set.
TNF = tumorje nekrotizirajoči faktor, n = število bolnikov v analizirani skupini.
In those patients experiencing liver enzyme elevation, modification of treatment regimen, such as reduction in the dose of concomitant DMARD, interruption of tofacitinib, or reduction in tofacitinib dose, resulted in decrease or normalisation of liver enzymes.
Pri tistih bolnikih z zvečanimi vrednostmi jetrnih encimov je prilagoditev režima zdravljenja, kot je zmanjšanje odmerka sočasno uporabljenega DMARD, prekinitev zdravljenja s tofacitinibom ali zmanjšanje odmerka tofacitiniba, povzročila zmanjšanje vrednosti jetrnih encimov ali povrnitev na normalne vrednosti.
For patients who have difficulties swallowing, tofacitinib tablets may be crushed and taken with water.
Bolnikom, ki imajo težave s požiranjem, se lahko tablete tofacitiniba zdrobi in jih vzamejo z vodo.
Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Indukcijsko zdravljenje s tofacitinibom je treba prekiniti pri vsakem bolniku, pri katerem po 16 tednih ne opazimo nobene koristi zdravljenja.
Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
Bolniki z revmatoidnim artritisom, ki jemljejo kortikosteroide, so lahko dovzetnejši za okužbe.
If needed, your doctor may interrupt your XELJANZ treatment to reduce the risk of infection (white blood cell counts) or anaemia (red blood cell counts).
Če bo treba, lahko zdravnik zdravljenje z zdravilom XELJANZ za nekaj časa prekine, da zmanjša tveganje za okužbo (število belih krvnih celic) ali anemijo (število rdečih krvnih celic).
• fluconazole, ketoconazole, used to treat fungal infections
• flukonazol in ketokonazol, ki se uporabljata za zdravljenje glivičnih okužb.
CD19+ B cell counts showed no further increases after long-term tofacitinib treatment.
Število celic B CD19+ se po dolgotrajnem zdravljenju s tofacitinibom ni dodatno zvečalo.
Cases of opportunistic infections have been reported (see section 4.4).
Poročali so o primerih oportunističnih okužb (glejte poglavje 4.4).
• 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.
• Pri bolnikih, ki so predhodno jemali biološka zdravila za zdravljenje ulceroznega kolitisa (kot so tista, ki zavirajo delovanje tumorje nekrotizirajočega faktorja v telesu) in ta niso bila učinkovita, se zdravnik lahko odloči za nadaljevanje zdravljenja z odmerkom 10 mg dvakrat na dan.
Treatment with tofacitinib resulted in significant improvements in some signs and symptoms of PsA, as assessed by the ACR20 response criteria compared to placebo at month 3.
Zdravljenje s tofacitinibom je povzročilo bistveno izboljšanje nekaterih znakov in simptomov PsA, ocenjeno po merilih za odziv ACR20, v primerjavi s placebom po 3 mesecih.
Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Tofacitinib se dobro absorbira, peroralna biološka uporabnost pa je 74 %.
In patients who have responded to treatment with tofacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Pri bolnikih, ki se odzovejo na zdravljenje s tofacitinibom, lahko zmanjšamo odmerek kortikosteroidov in/ali prekinemo zdravljenje z njimi v skladu s standardno oskrbo.
In the entire treatment experience with tofacitinib, the most commonly reported infection was nasopharyngitis, occurring in 18.2% of patients (211 patients).
V vseh preskušanjih zdravljenja s tofacitinibom je bila okužba, o kateri so najpogosteje poročali, nazofaringitis, ki se je pojavil pri 18,2 % bolnikov (211 bolnikov).
Health-related quality of life was assessed by SF-36v2, fatigue was assessed by the FACIT-F.
Z zdravjem povezano kakovost življenja so ocenili z vprašalnikom SF-36v2, utrujenost pa s funkcijsko oceno FACIT-F.
If you are a woman of childbearing age, you should use effective birth control during treatment with XELJANZ and for at least 4 weeks after the last dose.
Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom XELJANZ in še vsaj 4 tedne po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).
Sočasna uporaba tofacitiniba in močnih induktorjev CYP (npr. rifampicina) lahko povzroči izgubo ali zmanjšanje kliničnega odziva (glejte sliko 1).
A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Bolniku, pri katerem se med zdravljenjem s tofacitinibom pojavi nova okužba, je treba nemudoma opraviti celovito diagnostično obravnavo, primerno za imunoinkompetentnega bolnika, uvesti ustrezno protimikrobno zdravljenje in bolnika skrbno spremljati.
Child Pugh A No dose adjustment required.
Child-Pugh A Prilagajanje odmerka ni potrebno.
The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje v prvih 3 mesecih dvojno slepih, s placebom ali MTX nadzorovanih preskušanj, je bil 3,8 % pri bolnikih, ki so prejemali tofacitinib.
Caution should be exercised when considering initiation of tofacitinib treatment in patients with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST), particularly when initiated in combination with potentially hepatotoxic medicinal products such as MTX.
Pri razmisleku o uvedbi zdravljenja s tofacitinibom pri bolnikih z zvečanimi vrednostmi alanin-aminotransferaze (ALT) ali aspartat-aminotransferaze (AST) je potrebna previdnost, zlasti ob uvedbi v kombinaciji s potencialno hepatotoksičnimi zdravili, kot je MTX.
Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): okužba krvi (sepsa), razsejana tuberkuloza, ki zajame kosti in druge organe, ter druge neobičajne okužbe, okužbe sklepov.
Your doctor should perform blood tests before you start taking XELJANZ, and after 4 to 8 weeks of treatment and then every 3 months, to determine if you have a low white blood cell (neutrophil or lymphocyte) count, or a low red blood cell count (anaemia).
Zdravnik vam mora pred začetkom jemanja zdravila XELJANZ in po 4 do 8 tednih zdravljenja ter nato vsake 3 mesece opraviti krvne preiskave, da preveri, če imate zmanjšano število belih krvnih celic (nevtrofilcev ali limfocitov) ali rdečih krvnih celic (anemijo).
Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Farmakoterapevtski skupini: zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti; oznaka ATC: L04AA29.
Asian patients
Bolniki azijske rase
What XELJANZ is and what it is used for
Kaj je zdravilo XELJANZ in za kaj ga uporabljamo
• Patients with long standing RA who have previously received two or more biological disease modifying antirheumatic drugs (DMARDs).
• bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških imunomodulirajočih antirevmatičnih zdravil (DMARD),
They must not be crushed, split or chewed.
Ne smemo jih zdrobiti, razpoloviti ali žvečiti.
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:
Imetnik dovoljenja za promet z zdravilom mora v vsaki državi članici, kjer je zdravilo XELJANZ na trgu, vsem zdravstvenim delavcem in bolnikom/skrbnikom, ki bodo predvidoma predpisovali oziroma uporabljali zdravilo XELJANZ, zagotoviti dostop do naslednjih izobraževalnih gradiv:
Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Zdravljenje s tofacitinibom so prekinili, bolnik pa je po zdravljenju s standardnimi odmerki protivirusnih zdravil okreval.
Overall infections
Splošne okužbe
Ulcerative colitis is an inflammatory disease of the large bowel.
Ulcerozni kolitis je vnetna bolezen debelega črevesa.
After treatment with tofacitinib in RA patients, rapid decreases in serum C-reactive protein (CRP) were observed and maintained throughout dosing.
Po zdravljenju s tofacitinibom so pri bolnikih z RA opazili hitra zmanjšanja vrednosti C-reaktivnega proteina (CRP) v serumu, ki so se ohranila ves čas odmerjanja.
DAS28-4(ESR) response
Odziv DAS28-4(ESR)
Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the PK of tofacitinib.
Ni verjetno, da bi sami zaviralci CYP2C19 ali P-glikoprotein pomembno spremenili farmakokinetiko tofacitiniba.
The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Ocenjujejo, da je variabilnost vrednosti AUC tofacitiniba med preskušanci (odstotek koeficienta variance) približno 27 %.
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).
Ni dokazov o povezavi med resnimi ali oportunističnimi okužbami ali herpes zostrom in številom celic podskupin limfocitov (za spremljanje absolutnega števila limfocitov glejte poglavje 4.2).
Tofacitinib was secreted in milk of lactating rats at concentrations approximately 2-fold those in serum from 1 to 8 hours postdose.
Tofacitinib se je izločal v mleko pri doječih podganah pri koncentracijah, ki so bile približno 2-krat večje od koncentracij v serumu 1 do 8 ur po odmerjanju.
Patients in the phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Pri bolnikih v preskušanjih 3. faze je bila povprečna ocena aktivnosti bolezni (DAS28-4[ESR]) ob izhodišču 6,1-6,7.
• Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
• predhodna venska trombembolija - globoka venska tromboza ali pljučna embolija,
- The active substance is tofacitinib.
- Učinkovina je tofacitinib.