FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
Slovenian: Bolniki s hudo okvaro ledvic morajo tudi po hemodializi še naprej jemati zmanjšani odmerek (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: XELJANZ is used together with methotrexate to treat adult patients with active psoriatic arthritis.
Slovenian: Zdravilo XELJANZ se uporablja skupaj z metotreksatom za zdravljenje odraslih bolnikov z aktivnim psoriatičnim artritisom.
English: Do not take a double dose to make up for a forgotten 11 mg prolonged-release tablet.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo 11 mg tableto s podaljšanim sproščanjem.
English: In subjects with end-stage renal disease (ESRD), contribution of dialysis to the total clearance of tofacitinib was relatively small.
Slovenian: Pri preskušancih s končno ledvično odpovedjo je bil prispevek dialize k celokupnemu očistku tofacitiniba relativno majhen.
English: 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).
Slovenian: 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).
English: Events of gastrointestinal perforation have been reported in clinical trials although the role of JAK inhibition in these events is not known.
Slovenian: V kliničnih preskušanjih so poročali o primerih perforacije prebavil, čeprav vloga zaviranja JAK v teh primerih ni znana.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
English: Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo XELJANZ nima vpliva ali ima omejen vpliv na sposobnost vožnje in upravljanja strojev.
English: Some medicines should not be taken with XELJANZ.
Slovenian: Nekaterih zdravil ne smete jemati skupaj z zdravilom XELJANZ.
English: Tofacitinib should not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Tofacitiniba se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: 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)
Slovenian: FD&C Blue #2/indigotin (E132) (samo jakost 10 mg) FD&C Blue #1/briljantno modro FCF (E133) (samo jakost 10 mg)
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • who have resided or travelled in areas of endemic TB.
Slovenian: • ki so bivali na območjih z endemično TB ali so tja potovali.
English: If you take more XELJANZ than you should If you take more tablets than you should, immediately tell your doctor or pharmacist.
Slovenian: Če ste vzeli večji odmerek zdravila XELJANZ, kot bi smeli Če ste vzeli več tablet, kot bi smeli, nemudoma obvestite zdravnika ali farmacevta.
English: • unexplained changes in bowel habits
Slovenian: • nepojasnjene spremembe pri izločanju blata.
English: 60 film-coated tablets 180 film-coated tablets
Slovenian: 60 filmsko obloženih tablet 180 filmsko obloženih tablet
English: The impact of tofacitinib on chronic viral hepatitis reactivation is unknown.
Slovenian: Vpliv tofacitiniba na reaktivacijo kroničnega virusnega hepatitisa ni znan.
English: • Patients with an ALC less than 1,000 cells/mm
Slovenian: • bolnikih z ALC, manjšim od 1.000 celic/mm
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Slovenian: * p < 0,0001; **p < 0,001; †p < 0,05 za tofacitinib v primerjavi s placebom.
English: • blood in the stool
Slovenian: • kri v blatu,
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Population DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTX-naïve a
Slovenian: DMARD-IR DMARD-IR MTX-IR MTX-IR antagonist TNF-IR
English: 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.
Slovenian: 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.
English: At month 12 in OCTAVE Open, 52% (25/48) and 45% (37/83) of these patients achieved remission, respectively.
Slovenian: Po 12 mesecih v preskušanju OCTAVE Open je remisijo doseglo 52 % (25/48) oziroma 45 % (37/83) teh bolnikov.
English: 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).
Slovenian: 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).
English: Tofacitinib is a potent, selective inhibitor of the JAK family.
Slovenian: Tofacitinib je močan selektivni zaviralec encimov iz družine JAK.
English: Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Slovenian: 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.
English: If you are not sure regarding any of the information provided above, please contact your doctor.
Slovenian: Če ste glede katerekoli navedene informacije negotovi, se posvetujte z zdravnikom.
English: 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.
Slovenian: 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).
English: Month 6: ACR50
Slovenian: 6. mesec: ACR50
English: Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
Slovenian: Potrjeno ALC, manjše od 750 celic/mm 3, je bilo povezano z zvečano incidenco resnih okužb (glejte poglavje 4.4).
English: 56 film-coated tablets 112 film-coated tablets 182 film-coated tablets
Slovenian: 56 filmsko obloženih tablet 112 filmsko obloženih tablet 182 filmsko obloženih tablet
English: In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
Slovenian: V preskušanju OPAL BROADEN niso dovolili predhodnega zdravljenja z antagonistom TNF.
English: 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.
Slovenian: 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.
English: If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Slovenian: Če zdravljenje s tofacitinibom prekinemo, lahko razmislimo o ponovni uvedbi zdravljenja z njim.
English: Changes from baseline in HAQ-DI in studies ORAL Standard, ORAL Step and ORAL Sync are shown in Table 11.
Slovenian: Spremembe HAQ-DI od izhodišča v preskušanjih ORAL Standard, ORAL Step in ORAL Sync so prikazane v preglednici 11.
English: Each pack contains 28 or 91 prolonged-release tablets.
Slovenian: Eno pakiranje vsebuje 28 ali 91 tablet s podaljšanim sproščanjem.
English: Tofacitinib is given orally with or without food.
Slovenian: Tofacitinib dajemo peroralno s hrano ali brez nje.
English: Taking XELJANZ with these medicines may increase your risk of side effects including infection.
Slovenian: Jemanje zdravila XELJANZ skupaj s temi zdravili lahko poveča tveganje za pojav neželenih učinkov, vključno z okužbo.
English: In contrast to the observed decrease after short-term dosing, CD16/56+ natural killer cell counts showed a median increase of 73% from baseline.
Slovenian: Za razliko od zmanjšanja po kratkotrajnem odmerjanju se je mediano število naravnih celic ubijalk CD16/56+ zvečalo za 73 % glede na izhodiščno vrednost.
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Slovenian: Splošno statistično značilnost so dosegli pri p ≤ 0,05 po vnaprej določenem postopku testiranja s postopno regresijo.
English: It is not known whether tofacitinib is secreted in human milk.
Slovenian: Ni znano, ali se tofacitinib izloča v materino mleko.
English: Lipid monitoring
Slovenian: Spremljanje lipidov
English: 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.
Slovenian: 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.
English: Particular consideration should be given to patients with longstanding RA who have previously received two or more biological DMARDs.
Slovenian: Razmisliti je treba o profilaktičnem cepljenju proti pasovcu, zlasti pri bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških DMARD.
English: Improvement in fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at month 3 in all studies.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem stanj, za katera je tofacitinib indiciran.
English: Month 6: mT SS ACR70
Slovenian: 6. mesec: mTSS ACR70
English: 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.
Slovenian: 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.
English: If you forget to take XELJANZ
Slovenian: Če ste pozabili vzeti zdravilo XELJANZ
English: 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).
Slovenian: 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).
English: Drug hypersensitivity* Angioedema* Urticaria*
Slovenian: Bolezni imunskega sistema preobčutljivost na zdravilo*, angioedem*, urtikarija*
English: Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended.
Slovenian: Sočasna uporaba močnih induktorjev CYP3A4 in tofacitiniba ni priporočljiva.
English: In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
Slovenian: V vseh preskušanjih zdravljenja s tofacitinibom je bila celokupna stopnja incidence okužb 60,3 dogodka na 100 bolnikov-let (vključevala je 49,4 % bolnikov; skupno 572 bolnikov).
English: 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).
Slovenian: Pri bolnikih, zdravljenih s tofacitinibom, ki so Japonci ali Korejci, bolnikih z dolgotrajnim RA, ki so predhodno prejemali dva ali več bioloških DMARD, ali bolnikih z ALC, manjšim od 1.000 celic/mm in bolnikih, ki se zdravijo z odmerkom 10 mg dvakrat na dan, je tveganje za herpes zoster lahko zvečano (glejte poglavje 4.4).
English: Patients with latent TB, who test positive, should be treated with standard antimycobacterial therapy before administering tofacitinib.
Slovenian: Bolnike z latentno TB, pri katerih je test pozitiven, je treba pred začetkom uporabe tofacitiniba zdraviti s standardnimi zdravili za zdravljenje mikobakterijskih okužb.
English: Table 6: Adverse drug reactions
Slovenian: Preglednica 6: Neželeni učinki zdravila
English: Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development (see section 5.3).
Slovenian: Ugotovili so, da je tofacitinib teratogen pri podganah in kuncih ter da vpliva na kotitev in peri-/postnatalni razvoj (glejte poglavje 5.3).
English: Enrolled patients had failed at least 1 conventional therapy, including corticosteroids, immunomodulators, and/or a TNF inhibitor.
Slovenian: V preskušanja so vključili bolnike, pri katerih je bilo predhodno neučinkovito vsaj 1 običajno zdravljenje, ki je vključevalo kortikosteroide, imunomodulatorje in/ali antagonist TNF.
English: Other medicines and XELJANZ
Slovenian: Druga zdravila in zdravilo XELJANZ
English: All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
Slovenian: Vsi bolniki so morali sočasno prejemati 1 csDMARD; 71,6% bolnikov je sočasno prejemalo MTX, 15,7 % bolnikov je sočasno prejemalo sulfasalazin in 8,6 % bolnikov je sočasno prejemalo leflunomid.
English: The enzymatic activity of CYP enzymes is reduced in RA patients due to chronic inflammation.
Slovenian: Pri bolnikih z RA je encimska aktivnost encimov CYP zmanjšana zaradi kroničnega vnetja.
English: Pink, oval tablet of approximate average dimension of 10.8 mm × 5.5 mm × 4.4 mm (length by width by thickness) with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
Slovenian: Rožnata, ovalna tableta s približnimi povprečnimi merami 10,8 mm × 5,5 mm × 4,4 mm (dolžina krat širina krat debelina), z izvrtano luknjico na enem koncu oboda tablete in natisnjeno oznako ''JKI 11'' na eni strani tablete.
English: Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins (IL-2, -4, -6, -7, -9, -15, -21) and type I and type II interferons, which will result in modulation of the immune and inflammatory response.
Slovenian: Tofacitinib z zaviranjem kinaz JAK1 in JAK3 oslabi signaliziranje interlevkinov (IL-2, -4, -6,7, -9, -15, -21) ter interferonov tipa I in II, kar povzroči spremembo imunskega in vnetnega odziva.
English: All patients were required to have 1 concomitant csDMARD; 83.9% of patients received concomitant MTX, 9.5% of patients received concomitant sulfasalazine, and 5.7% of patients received concomitant leflunomide.
Slovenian: Vsi bolniki so morali sočasno prejemati 1 csDMARD; 83,9 % bolnikov je sočasno prejemalo MTX, 9,5 % bolnikov je sočasno prejemalo sulfasalazin in 5,7 % bolnikov je sočasno prejemalo leflunomid.
English: Treatment with tofacitinib was associated with an increased incidence of lymphopenia compared to placebo.
Slovenian: Zdravljenje s tofacitinibom je bilo povezano z zvečano incidenco limfopenije v primerjavi s placebom.
English: Tablet core sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
Slovenian: Jedro tablete sorbitol (E420) hidroksietilceluloza kopovidon magnezijev stearat
English: Efficacy may be regained by 8 weeks of 10 mg twice daily therapy (see section 5.1).
Slovenian: Učinkovitost lahko ponovno dosežemo z 8-tedenskim zdravljenjem z odmerkom 10 mg dvakrat na dan (glejte poglavje 5.1).
English: Results from population PK analysis in patients with active PsA or moderate to severe UC were consistent with those in patients with RA.
Slovenian: Rezultati populacijske analize farmakokinetike pri bolnikih z aktivnim PsA ali zmernim do hudim UK so bili skladni z rezultati pri bolnikih z RA.
English: Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Slovenian: Odmerek tofacitiniba 10 mg dvakrat na dan je kontraindiciran pri bolnikih z enim ali več od naslednjih stanj:
English: Concomitant stable doses of oral aminosalicylates and corticosteroids (prednisone or equivalent daily dose up to 25 mg) were permitted with taper of corticosteroids to discontinuation mandated within 15 weeks of entering the maintenance study.
Slovenian: Sočasno jemanje stabilnih odmerkov peroralnih aminosalicilatov in kortikosteroidov (dnevni odmerek prednizona ali druge enakovredne učinkovine do 25 mg) so dovolili s postopnim zmanjševanjem odmerka kortikosteroidov do prekinitve zdravljenja, do katere je moralo priti v 15 tednih od vključitve v preskušanje vzdrževalnega zdravljenja.
English: Tofacitinib 11 mg prolonged-release tablets must be taken whole in order to ensure the entire dose is delivered correctly.
Slovenian: Tofacitinib 11 mg tablete s podaljšanim sproščanjem je treba vzeti cele, da zagotovimo pravilen vnos celotnega odmerka.
English: Nominal p<0.0001 for active treatment versus placebo at month 3.
Slovenian: nominalna vrednost p < 0,0001 za aktivno zdravljenje v primerjavi s placebom po 3. mesecih.
English: Each pack contains 56, 112, or 182 film-coated tablets.
Slovenian: Eno pakiranje vsebuje 56, 112 ali 182 filmsko obloženih tablet.
English: Women of childbearing potential should be advised to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
Slovenian: Ženskam v rodni dobi je treba svetovati, da morajo med zdravljenjem s tofacitinibom in vsaj še 4 tedne po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
English: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely.
Slovenian: Tofacitinib se presnavlja preko CYP3A4, zato je medsebojno delovanje z zdravili, ki zavirajo ali inducirajo CYP3A4, verjetno.
English: - The 11 mg prolonged-release tablets are provided in blisters containing 7 prolonged-release tablets.
Slovenian: - 11 mg tablete s podaljšanim sproščanjem so na voljo v pretisnih omotih, ki vsebujejo 7 tablet s podaljšanim sproščanjem.
English: The recommended dose is one 11 mg prolonged-release tablet administered once daily.
Slovenian: Priporočeni odmerek je ena 11 mg tableta s podaljšanim sproščanjem enkrat na dan.
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Slovenian: V nadzorovanih kliničnih preskušanjih pri bolnikih z RA, ki so jim uvedli 10 mg tofacitiniba dvakrat na dan ali placebo, je bilo število bolnikov, ki so se odzvali na cepivo proti gripi, v obeh skupinah podobno: tofacitinib (57 %) in placebo (62 %).
English: Following long-term treatment (median duration of tofacitinib treatment of approximately 5 years), CD4+ and CD8+ counts showed median reductions of 28% and 27%, respectively, from baseline.
Slovenian: Po dolgotrajnem zdravljenju (mediano trajanje zdravljenja s tofacitinibom približno 5 let) se je mediano število celic CD4+ zmanjšalo za 28 %, število celic CD8+ pa za 27 % glede na izhodiščno vrednost.