FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire Disability Index; N=total number of patients in the statistical analysis; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor.
Slovenian: Okrajšave: DMARD = imunomodulirajoče antirevmatično zdravilo; HAQ-DI = indeks oviranosti po vprašalniku za oceno zdravstvenega stanja (Health Assessment Questionnaire Disability Index); n = skupno število bolnikov v statistični analizi; SC q2w = subkutano enkrat na 2 tedna; TNF = tumorje nekrotizirajoči faktor.
English: Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Slovenian: Sočasna uporaba ketokonazola in flukonazola je zvečala vrednost Cmax tofacitiniba, medtem ko so takrolimus, ciklosporin in rifampicin zmanjšali vrednost Cmax tofacitiniba.
English: • The website repository shall contain: o The educational material in digital format o The patient alert card in digital format
Slovenian: • Spletni repozitorij mora vsebovati: o izobraževalno gradivo v elektronski obliki; o opozorilno kartico za bolnika v elektronski obliki.
English: Table 9: Number (%) of subjects achieving DAS28-4(ESR) < 2.6 remission at months 3 and 6
Slovenian: Preglednica 9: Število (%) preskušancev, ki so dosegli remisijo DAS28-4(ESR) < 2,6 v 3. in 6. mesecu
English: The efficacy and safety of tofacitinib for the treatment of adult patients with moderately to severely active UC (Mayo score 6 to 12 with endoscopy subscore ≥ 2 and rectal bleeding subscore ≥ 1) were assessed in 3 multicentre, double-blind, randomised, placebo-controlled studies: 2 identical induction studies (OCTAVE Induction 1 and OCTAVE Induction 2) followed by 1 maintenance study (OCTAVE Sustain).
Slovenian: Učinkovitost in varnost tofacitiniba pri zdravljenju odraslih bolnikov z zmerno do močno aktivnim UK (ocena Mayo od 6 do 12 z endoskopsko podoceno ≥ 2 in podoceno rektalnih krvavitev ≥ 1) so ocenili v 3 multicentričnih, dvojno slepih, randomiziranih in s placebom nadzorovanih preskušanjih: 2 identičnih preskušanjih indukcijskega zdravljenja (OCTAVE Induction 1 in OCTAVE Induction 2), ki jima je sledilo 1 preskušanje vzdrževalnega zdravljenja (OCTAVE Sustain).
English: 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.
Slovenian: Po dodatnih 8 tednih zdravljenja z 10 mg tofacitiniba dvakrat na dan v preskušanju OCTAVE Open je 53 % (154/293) bolnikov doseglo klinični odziv, 14 % (42/293) bolnikov pa remisijo.
English: Gastrointestinal obstruction with a non-deformable prolonged-release formulation
Slovenian: Obstrukcija prebavil pri jemanju zdravil z nedeformabilno formulacijo s podaljšanim sproščanjem
English: Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation in some patients (see section 4.8 liver enzyme tests).
Slovenian: Zdravljenje s tofacitinibom je bilo pri nekaterih bolnikih povezano z zvečano incidenco zvečanja vrednosti jetrnih encimov (glejte Testi jetrnih encimov v poglavju 4.8).
English: In a human radiolabelled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
Slovenian: V študiji radioaktivno označenega zdravila pri človeku je več kot 65 % celokupne radioaktivnosti v obtoku prispevala nespremenjena učinkovina, preostalih 35 % pa 8 presnovkov, pri čemer je vsak od posameznih presnovkov prispeval manj kot 8 % celokupne radioaktivnosti.
English: If drug-induced liver injury is suspected, the administration of tofacitinib should be interrupted until this diagnosis has been excluded.
Slovenian: Ob sumu na z zdravilom povzročeno poškodbo jeter je treba dajanje tofacitiniba prekiniti, dokler ta diagnoza ni izključena.
English: In study OPAL BROADEN, the progression of structural joint damage was assessed radiographically utilising the van der Heijde modified Total Sharp Score (mTSS) and the proportion of patients with radiographic progression (mTSS increase from baseline greater than 0.5) was assessed at month 12.
Slovenian: V preskušanju OPAL BROADEN so napredovanje strukturnih poškodb sklepov ocenili radiografsko z van der Heijdejevo prirejeno Sharpovo lestvico (mTSS), po 12 mesecih pa so ocenili delež bolnikov, pri katerih je bolezen radiografsko napredovala (zvišanje mTSS za več kot 0,5 od izhodišča).
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism (see also section 4.3).
Slovenian: Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z velikim tveganjem za pljučno embolijo (glejte tudi poglavje 4.3).
English: RA and PsA patients have an increased risk for cardiovascular disorders.
Slovenian: Bolniki z RA in PsA imajo zvečano tveganje za nastanek srčno-žilnih bolezni.
English: Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Slovenian: V preskušanjih, ki so trajala do dve leti, so trajnost učinka ocenili s stopnjami odziva ACR20, ACR50 in ACR70.
English: There have been reports of patients treated with XELJANZ who have developed blood clots.
Slovenian: Pri bolnikih, ki so prejemali zdravilo XELJANZ, so poročali o krvnih strdkih.
English: • If maintaining XELJANZ 5 mg twice a day did not work for you, your doctor may decide to increase the dose to 10 mg twice a day.
Slovenian: • Če zdravljenje s 5 mg zdravila XELJANZ dvakrat na dan pri vas ne bo učinkovito, lahko zdravnik poveča odmerek na 10 mg na dan.
English: Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Slovenian: Tofacitinib se je izločal v mleko doječih podgan (glejte poglavje 5.3).
English: Prior to initiating tofacitinib, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Slovenian: Pred začetkom zdravljenja s tofacitinibom je priporočljivo pri vseh bolnikih opraviti vsa cepljenja skladno z veljavnimi smernicami za cepljenje.
English: It is recommended that live vaccines not be given concurrently with tofacitinib.
Slovenian: Živih cepiv ni priporočljivo dajati sočasno s tofacitinibom.
English: Induction efficacy data (OCTAVE Induction 1 and OCTAVE Induction 2) The primary endpoint of OCTAVE Induction 1 and OCTAVE Induction 2 was the proportion of patients in remission at week 8, and the key secondary endpoint was the proportion of patients with improvement of endoscopic appearance of the mucosa at week 8.
Slovenian: Podatki o učinkovitosti indukcijskega zdravljenja (OCTAVE Induction 1 in OCTAVE Induction 2) Primarni opazovani dogodek v preskušanjih OCTAVE Induction 1 in OCTAVE Induction 2 je bil delež bolnikov v remisiji po 8 tednih, ključni sekundarni opazovani dogodek pa je bil delež bolnikov, pri katerih so po 8 tednih opazili izboljšanje endoskopskega videza sluznice.
English: In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.
Slovenian: V preskušanjih indukcijskega in vzdrževalnega zdravljenja so bili najpogostejši resni neželeni učinki v skupinah, ki so jih zdravili s tofacitinibom in placebom, iz skupine bolezni prebavil in okužb, najpogostejši resni neželeni učinek pa je bil poslabšanje UK.
English: Study VII (O RAL Strategy)
Slovenian: Preskušanje VII (ORAL Strategy)
English: 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).
Slovenian: Pogostnosti neželenih učinkov so opredeljene na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: 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.
Slovenian: Med preskušanjem ORAL Strategy so bili odzivi na tofacitinib 5 mg dvakrat na dan + MTX številčno podobni kot pri adalimumabu 40 mg + MTX, oboji pa so bili številčno večji kot pri tofacitinibu 5 mg dvakrat na dan.
English: The effect of tofacitinib on the development and course of malignancies is not known.
Slovenian: Učinek zdravljenja s tofacitinibom na razvoj in potek malignih bolezni ni znan.
English: For both studies, the primary endpoints were ACR20 response rate and change from baseline in HAQ-DI at month 3.
Slovenian: V obeh preskušanjih sta bila primarna opazovana dogodka stopnja odziva ACR20 in sprememba HAQ-DI od izhodišča do 3. meseca.
English: Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
Slovenian: Pri bolnikih, ki so tofacitinib prejemali v kliničnih preskušanjih za RA in v obdobju trženja zdravila, so poročali o primerih intersticijske pljučne bolezni (nekateri od njih s smrtnim izidom), čeprav vloga zaviranja Janusovih kinaz (JAK) pri teh primerih ni znana.
English: In ORAL Start, tofacitinib monotherapy resulted in significantly greater inhibition of the progression of structural damage compared to MTX at months 6 and 12 as shown in Table 10, which was also maintained at month 24.
Slovenian: V preskušanju ORAL Start je monoterapija s tofacitinibom v 6. in 12. mesecu pomembno bolj zavirala napredovanje strukturnih poškodb v primerjavi z MTX, kot je prikazano v preglednici 10, učinek pa je bil ohranjen še v 24. mesecu.
English: 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.
Slovenian: Delež bolnikov v obeh skupinah, zdravljenih s tofacitinibom, pri katerih zdravljenje ni bilo več učinkovito, je bil manjši v primerjavi s placebom na vseh časovnih točkah že od 8. tedna, prve časovne točke, na kateri so ocenili neučinkovitost zdravljenja, kot prikazuje slika 2.
English: In enzymatic assays, tofacitinib inhibits JAK1, JAK2, JAK3, and to a lesser extent TyK2.
Slovenian: Pri encimskih testih tofacitinib zavira JAK1, JAK2 in JAK3 ter v manjši meri TyK2.
English: ANC should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Slovenian: ANC je treba preveriti ob izhodišču, po 4-8 tednih in nato vsake 3 mesece.
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
Slovenian: • Zdravnik se lahko odloči za prekinitev zdravljenja z zdravilom XELJANZ, če zdravilo po 16 tednih pri vas ne bo učinkovito.
English: Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
English: Following a single dose of 10 mg, mean AUC in subjects with ESRD based on concentrations measured on a non-dialysis day was approximately 40% (90% confidence intervals: 1.5-95%) higher compared to subjects with normal renal function.
Slovenian: Pri preskušancih s končno ledvično odpovedjo je bila povprečna vrednost AUC na podlagi koncentracij, izmerjenih na dan brez dialize, po enem 10 mg odmerku približno za 40 % (90 % intervali zaupanja: 1,5-95 %) večja kot pri preskušancih z normalnim delovanjem ledvic.
English: Upon withdrawal of tofacitinib treatment, lipid levels returned to baseline.
Slovenian: Po prekinitvi zdravljenja s tofacitinibom so se vrednosti lipidov vrnile na izhodiščno vrednost.
English: RA patients have an increased risk for cardiovascular disorders.
Slovenian: Bolniki z RA imajo zvečano tveganje za nastanek srčno-žilnih bolezni.
English: Lymphocytes should be monitored at baseline and every 3 months thereafter.
Slovenian: Število limfocitov je treba preveriti ob izhodišču in nato vsake 3 mesece.
English: Common ≥1/100 to <1/10
Slovenian: Organski sistem Pogosti ≥ 1/100 do < 1/10
English: Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52.
Slovenian: Ohranjena remisija brez jemanja kortikosteroidov je pomenila, da je bil bolnik v remisiji in ni jemal kortikosteroidov vsaj 4 tedne pred obiskom po 24 tednih in obiskom po 52 tednih.
English: Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
Slovenian: Zdravljenje s tofacitinibom je povezano z znižanji ravni hemoglobina.
English: In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
Slovenian: V preskušanjih ORAL Scan in ORAL Start so zaviranje napredovanja strukturnih poškodb sklepov ocenili radiografsko v 6. in 12. mesecu in ga izrazili kot povprečno spremembo ocene po prirejeni Sharpovi lestvici (mTSS - modified Total Sharp Score) in njenih komponentah, ocene erozije sklepov in ocene zožitve sklepne špranje (JSN - Joint Space Narrowing) glede na izhodišče.
English: Rheumatoid arthritis and psoriatic arthritis
Slovenian: Revmatoidni artritis in psoriatični artritis
English: 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).
Slovenian: Učinkovitost in varnost tofacitiniba so ocenili v 2 randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih 3. faze pri odraslih bolnikih z aktivnim PsA (≥ 3 otekli in ≥ 3 občutljivi sklepi).
English: Tofacitinib distributes equally between red blood cells and plasma.
Slovenian: Tofacitinib se enakomerno porazdeli med eritrocite in plazmo.
English: XELJANZ is not recommended for use in children or adolescents under 18 years of age.
Slovenian: Uporaba zdravila XELJANZ pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
English: Table 5: Dose adjustment for renal impairment Renal impairment category
Slovenian: Preglednica 5: Prilagajanje odmerka pri okvari ledvic Kategorija okvare ledvic
English: Tofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs.
Slovenian: Tofacitinib je v kombinaciji z metotreksatom (MTX - Methotrexate) indiciran za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa (RA) pri odraslih bolnikih, ki so se nezadostno odzvali ali imajo intoleranco na enega ali več imunomodulirajočih antirevmatičnih zdravil.
English: • Patients treated with 10 mg twice daily.
Slovenian: • bolnikih, ki se zdravijo z odmerkom 10 mg dvakrat na dan.
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other medicinal products utilising a non-deformable prolonged-release formulation.
Slovenian: V redkih primerih so pri bolnikih z znanimi strikturami v povezavi z zaužitjem drugih zdravil z nedeformabilno formulacijo s podaljšanim sproščanjem poročali o obstruktivnih simptomih.
English: The pharmacologic activity of tofacitinib is attributed to the parent molecule.
Slovenian: Farmakološko aktivnost tofacitiniba pripisujejo nespremenjeni molekuli.
English: In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
Slovenian: V populacijah z RA, pri katerih so preučevali dolgoročno varnost, so bila zvečanja vrednosti lipidnih parametrov skladna z zvečanji, ki so jih opazili v nadzorovanih kliničnih preskušanjih.
English: The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih, ki so v preskušanjih indukcijskega zdravljenja prejemali 10 mg tofacitiniba dvakrat na dan, so bili glavobol, nazofaringitis, navzea in artralgija.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism.
Slovenian: Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z velikim tveganjem za pljučno embolijo.
English: 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.
Slovenian: Tveganje za NMSC je lahko večje pri bolnikih, ki se zdravijo z 10 mg tofacitiniba dvakrat na dan, kot pri bolnikih, ki se zdravijo s 5 mg dvakrat na dan.
English: HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets.
Slovenian: Plastenke iz HDPE s silikagelom kot sušilnim sredstvom in za otroke varno polipropilensko zaporko, ki vsebujejo 60 ali 180 filmsko obloženih tablet.
English: The extent of decrease in MTX exposure does not warrant modifications to the individualised dosing of MTX.
Slovenian: Spremembe individualnega odmerjanja MTX zaradi zmanjšanja izpostavljenosti MTX niso potrebne.
English: • hives (itching or skin rash)
Slovenian: • koprivnico (srbenje ali kožni izpuščaj).
English: OCTAVE induction study 2
Slovenian: Preskušanje OCTAVE Induction 2
English: Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development.
Slovenian: Dokazali so, da je tofacitinib teratogen pri podganah in kuncih in pri podganah vpliva na plodnost samic (zmanjšana stopnja brejosti; zmanjšanje števila rumenih telesc, mest implantacije in za preživetje sposobnih plodov; ter zvečanje števila zgodnjih resorpcij), kotitev in peri-/postnatalni razvoj.
English: What XELJANZ looks like and contents of the pack
Slovenian: Izgled zdravila XELJANZ in vsebina pakiranja
English: Coadministration of tofacitinib 11 mg prolonged-release tablet with a high-fat meal resulted in no changes in AUC while Cmax was increased by 27%.
Slovenian: Pri sočasni uporabi tofacitiniba 11 mg tablet s podaljšanim sproščanjem z obrokom z veliko vsebnostjo maščob se vrednost AUC ni spremenila, vrednost Cmax pa se je zvečala za 27 %.
English: Rare ≥1/10,000 to
Slovenian: Redki ≥ 1/10.000 do
English: When given at a dose of 5 mg twice daily, tofacitinib plus MTX exhibited similar effects on mean progression of structural damage (not statistically significant).
Slovenian: Dajanje tofacitiniba v odmerku 5 mg dvakrat na dan sočasno z MTX je imelo podobne učinke na povprečno napredovanje strukturnih poškodb (razlike niso bile statistično pomembne).
English: XELJANZ is used to treat a condition called psoriatic arthritis.
Slovenian: Zdravilo XELJANZ se uporablja za zdravljenje bolezni, ki jo imenujemo psoriatični artritis.
English: White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other.
Slovenian: Bela, okrogla tableta premera 7,9 mm, z vtisnjeno oznako “Pfizer” na eni in “JKI 5” na drugi strani.
English: Study III (O RAL Standard)
Slovenian: Preskušanje III (ORAL Standard)
English: Normalisation of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
Slovenian: Normalizacijo endoskopskega videza sluznice so opredelili kot endoskopska podocena Mayo 0.
English: Consultation with a healthcare professional with expertise in the treatment of TB is recommended to aid in the decision about whether initiating antituberculosis therapy is appropriate for an individual patient.
Slovenian: Pri odločanju o ustreznosti uvedbe zdravljenja TB pri posameznem bolniku se je priporočljivo posvetovati z zdravnikom specialistom za zdravljenje TB.
English: • The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Slovenian: • Priporočeni odmerek je 10 mg dvakrat na dan 8 tednov in zatem 5 mg dvakrat na dan.
English: XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.
Slovenian: Zdravilo XELJANZ se lahko uporablja tudi samostojno v primerih, če bolnik zdravljenja z metotreksatom ne prenaša ali zdravljenje z metotreksatom ni priporočljivo.
English: Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other.
Slovenian: Modra, okrogla tableta premera 9,5 mm, z vtisnjeno oznako “Pfizer” na eni in “JKI 10” na drugi strani.
English: For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance.
Slovenian: Bolniki, ki po 8 tednih ne dosežejo ustrezne koristi zdravljenja, lahko indukcijski odmerek 10 mg dvakrat na dan prejemajo še dodatnih 8 tednov (skupno torej 16 tednov), čemur sledi 5 mg dvakrat na dan za vzdrževalno zdravljenje.
English: Uncommon ≥1/1,000 to
Slovenian: Občasni ≥ 1/1.000 do
English: If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.
Slovenian: Če jemljete zdravilo XELJANZ in dojite, morate dojenje prekiniti, dokler se ne posvetujete z zdravnikom o prekinitvi zdravljenja z zdravilom XELJANZ.
English: 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.
Slovenian: Pri 6-mesečnem odmerjanju tofacitiniba pri bolnikih z RA so bile spremembe ravni skupnih protiteles IgG, IgM in IgA v serumu majhne, neodvisne od odmerka in podobne spremembam, ki so jih opazili pri placebu, kar kaže na odsotnost sistemskega zaviranja humoralnega odziva.
English: What XELJANZ is and what it is used for What you need to know before you take XELJANZ How to take XELJANZ
Slovenian: Kaj je zdravilo XELJANZ in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo XELJANZ Kako jemati zdravilo XELJANZ Možni neželeni učinki
English: Liver enzyme tests
Slovenian: Testi jetrnih encimov
English: XELJANZ can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection - if you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis.
Slovenian: Zdravilo XELJANZ lahko zmanjša sposobnost telesa za odzivanje na okužbe in poslabša obstoječe okužbe ali zveča verjetnost za pojav nove okužbe.
English: The risks and benefits of treatment should be considered prior to initiating tofacitinib in patients:
Slovenian: Pred začetkom zdravljenja s tofacitinibom je treba pretehtati tveganja in koristi zdravljenja pri bolnikih:
English: XELJANZ is for oral use.
Slovenian: Zdravilo XELJANZ je za peroralno uporabo.
English: N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Slovenian: n = 59 za placebo, n = 65 za 5 mg odmerek tofacitiniba dvakrat na dan, n = 55 za 10 mg odmerek tofacitiniba dvakrat na dan.