FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement from baseline compared to placebo in the SF-36v2 physical functioning domain, the SF-36v2 physical component summary score, and FACIT-F scores at month 3 in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Slovenian: Pri bolnikih, ki so prejemali 5 mg tofacitiniba dvakrat na dan, so v preskušanjih OPAL BROADEN in OPAL BEYOND po 3 mesecih opazili večje izboljšanje telesne funkcije po SF36v2, rezultatov povzetka telesne komponente SF-36v2 in ocen FACIT-F od izhodišča v primerjavi s placebom (nominalna vrednost p ≤ 0,05).
English: Vaccine studies
Slovenian: Preskušanja s cepivi
English: ACR20 Month 3 Month 6 Month 12
Slovenian: ACR20 3. mesec 6. mesec 12. mesec
English: Film coat cellulose acetate hydroxypropyl cellulose (E463) hypromellose (E464) titamium dioxide (E171) triacetin (E1518) red iron oxide (E172)
Slovenian: Filmska obloga celulozni acetat hidroksipropilceluloza (E463) hipromeloza (E464) titanov dioksid (E171) triacetin (E1518) rdeči železov oksid (E172)
English: Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure
Slovenian: izboljšanje endoskopskega videza sluznice predhodno neučinkovito zdravljenje z zaviralcem TNF
English: Placebo Placebo
Slovenian: Kontrolna skupina placebo placebo placebo placebo placebo
English: No dose adjustment is required when used in combination with MTX.
Slovenian: Pri uporabi v kombinaciji z MTX prilagajanje odmerka ni potrebno.
English: Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Slovenian: Pri bolnikih, ki so prejemali 5 mg tofacitiniba dvakrat na dan, so po 3 mesecih opazili večje izboljšanje (p ≤ 0,05) telesne funkcije od izhodišča v primerjavi s placebom (glejte preglednico 13).
English: Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Slovenian: Med oportunističnimi okužbami so pri zdravljenju s tofacitinibom poročali o TB in drugih mikobakterijskih okužbah, okužbi s kriptokokom, histoplazmozi, kandidozi požiralnika, multidermatomalnem herpes zostru, citomegalovirusu, okužbah z virusom BK in listeriozi.
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, laktoza monohidrat (glejte poglavje 2), premreženi natrijev karmelozat, magnezijev stearat, hipromeloza (E464), titanov dioksid (E171), makrogol, triacetin (E1518), FD&C Blue #2/indigotin (E132) in FD&C Blue #1/briljantno modro FCF (E133).
English: Confirmed increases in liver enzymes greater than 3 times the upper limit of normal (3x ULN) were uncommonly observed in RA patients.
Slovenian: Pri bolnikih z RA so občasno opazili potrjena zvečanja vrednosti jetrnih encimov, večja od 3-kratne zgornje meje normalne vrednosti (3 x ZMN).
English: • The patient information pack should contain: o Patient information leaflet o The patient alert card
Slovenian: • Paket izobraževalnih gradiv za bolnika mora vsebovati: o navodilo za uporabo; o opozorilno kartico za bolnika.
English: Potential for tofacitinib to influence the PK of other medicinal products
Slovenian: Možnost vpliva tofacitiniba na farmakokinetiko drugih zdravil
English: Steady state concentrations are achieved in 24-48 hours with negligible accumulation after twice daily administration.
Slovenian: Po odmerjanju dvakrat na dan zdravilo doseže koncentracije v stanju dinamičnega ravnovesja v 24-48 urah z zanemarljivim kopičenjem.
English: Tofacitinib 10 mg twice daily + DMARD(s) ORAL Sync: DMARD inadequate responders
Slovenian: tofacitinib 10 mg dvakrat na dan + DMARD**** ORAL Sync: bolniki z nezadostnim odzivom na DMARD
English: At baseline, 79.9% and 56.2% of patients had enthesitis and dactylitis, respectively.
Slovenian: Ob izhodišču je 79,9 % bolnikov imelo entezitis, 56,2 % bolnikov pa daktilitis.
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section 4.3).
Slovenian: Uporaba tofacitiniba med nosečnostjo je iz previdnosti kontraindicirana (glejte poglavje 4.3).
English: Tofacitinib with and without MTX in comparison to ADA with MTX
Slovenian: monoterapija, kontrolna učinkovina (MTX), rentgen tofacitinib z MTX ali brez njega v primerjavi z ADA z MTX
English: Study II (O RAL Sync)
Slovenian: Preskušanje II (ORAL Sync)
English: Patients who completed 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) but did not achieve clinical response or patients who completed or withdrew early due to treatment failure in the maintenance study (OCTAVE Sustain) were eligible for OCTAVE Open.
Slovenian: Za vključitev v preskušanje OCTAVE Open so bili primerni bolniki, ki so dokončali eno od preskušanj indukcijskega zdravljenja (OCTAVE Induction 1 ali OCTAVE Induction 2), vendar niso dosegli kliničnega odziva, in bolniki, ki so dokončali preskušanje vzdrževalnega zdravljenja (OCTAVE Sustain) ali so iz njega predčasno izstopili zaradi neučinkovitosti zdravljenja.
English: Subjects with mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had 3%, and 65% higher AUC, respectively, compared to subjects with normal hepatic function.
Slovenian: V primerjavi s preskušanci z normalnim delovanjem jeter je bila vrednost AUC pri preskušancih z blago (Child-Pugh A) in zmerno okvaro jeter (Child-Pugh B) večja za 3 % oziroma 65 %.
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Slovenian: Sočasna uporaba tofacitiniba pri zdravih prostovoljkah ni vplivala na farmakokinetiko peroralnih kontraceptivov, levonorgestrela in etinilestradiola.
English: Retreatment in UC
Slovenian: Ponovno zdravljenje pri UK
English: Table 17: Proportion of patients meeting efficacy endpoints at week 52 (OCTAVE sustain) Central endoscopy read
Slovenian: Preglednica 17: Delež bolnikov, pri katerih so po 52 tednih potrdili opazovane dogodke učinkovitosti (OCTAVE Sustain) Centraliziran pregled endoskopskih posnetkov
English: 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Slovenian: Ob izhodišču je 80,7 % bolnikov imelo entezitis, 49,2 % bolnikov pa daktilitis.
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Slovenian: Pri bolnikih, ki so prejemali tofacitinib, so poročali o resnih in včasih smrtnih okužbah z bakterijskimi, mikobakterijskimi, invazivnimi glivičnimi, virusnimi in drugimi oportunističnimi patogeni.
English: Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with tofacitinib.
Slovenian: Pred začetkom zdravljenja s tofacitinibom je treba opraviti presejanje za virusni hepatitis skladno s kliničnimi smernicami.
English: There is a higher rate of infections in patients aged 65 years and older.
Slovenian: Pri bolnikih, starih 65 let in več, so okužbe pogostejše.
English: If you stop taking XELJANZ You should not stop taking XELJANZ without discussing this with your doctor.
Slovenian: Če ste prenehali jemati zdravilo XELJANZ Zdravila XELJANZ ne smete prenehati jemati, ne da bi se prej posvetovali z zdravnikom.
English: Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during administration of tofacitinib.
Slovenian: Pred uporabo tofacitiniba in med njo je treba bolnike pregledati ter testirati glede latentne ali aktivne okužbe skladno z veljavnimi smernicami.
English: -0.35c,*
Slovenian: 3. mesec c,*
English: In the 6-month and 24-month, controlled clinical studies, the rate of serious infections in the 5 mg twice daily tofacitinib monotherapy group was 1.7 patients with events per 100 patient-years.
Slovenian: V 6- in 24-mesečnem nadzorovanem kliničnem preskušanju je bila stopnja resnih okužb v skupini, ki je prejemala monoterapijo s 5 mg tofacitiniba dvakrat na dan, 1,7 bolnika z dogodki na 100 bolnikov let.
English: Dyslipidaemia Hyperlipidaemia Dehydration
Slovenian: Presnovne in prehranske motnje dislipidemija, hiperlipidemija, dehidracija
English: XELJANZ 11 mg prolonged-release tablets have been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.
Slovenian: Dokazali so, da zdravilo XELJANZ 11 mg tablete s podaljšanim sproščanjem samostojno ali v kombinaciji z metotreksatom zmanjša bolečine in otekanje sklepov ter izboljša sposobnost izvajanja vsakodnevnih dejavnosti.
English: Tofacitinib treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Slovenian: Če se pri bolniku pojavi resna okužba, je treba zdravljenje s tofacitinibom prekiniti, dokler okužba ni pod nadzorom.
English: Do not take XELJANZ - if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6) - if you have a severe infection such as bloodstream infection or active tuberculosis
Slovenian: Ne jemljite zdravila XELJANZ - če ste alergični na tofacitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: MTX N=168 Mean (SD)
Slovenian: n = 168 povprečje (SD)
English: You should not switch between the XELJANZ 5 mg film-coated tablet and the XELJANZ 11 mg prolonged-release tablet unless instructed by your doctor.
Slovenian: Zdravila XELJANZ 5 mg filmsko obložene tablete in zdravila XELJANZ 11 mg tablete s podaljšanim sproščanjem ne smete zamenjati, razen če vam je tako naročil zdravnik.
English: Impact of other medicinal products on PK of tofacitinib
Slovenian: Vpliv drugih zdravil na farmakokinetiko tofacitiniba
English: Potential for other medicinal products to influence the pharmacokinetics (PK) of tofacitinib
Slovenian: Možnost vpliva drugih zdravil na farmakokinetiko tofacitiniba
English: The risks and benefits of tofacitinib treatment should be considered prior to initiating therapy in patients with current or a history of malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing tofacitinib in patients who develop a malignancy.
Slovenian: Pred uvedbo zdravljenja je treba pri bolnikih z maligno boleznijo ali malignimi boleznimi v anamnezi, z izjemo uspešno zdravljenega nemelanomskega kožnega raka (NMSC - Non-Melanoma Skin Cancer), ali pri razmisleku o nadaljevanju zdravljenja s tofacitinibom pri bolnikih, pri katerih se pojavi malignost, pretehtati tveganja in koristi zdravljenja s tofacitinibom.
English: Tofacitinib is not mutagenic or genotoxic based on the results of a series of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Slovenian: Na podlagi rezultatov vrste testov genskih mutacij in kromosomskih aberacij in vitro ter in vivo tofacitinib ni mutagen ali genotoksičen.
English: Improvement of endoscopic appearance of the mucosa was defined as endoscopy subscore of 0 or 1.
Slovenian: Izboljšanje endoskopskega videza sluznice so opredelili kot endoskopska podocena 0 ali
English: In ORAL Standard and ORAL Scan, mean FACIT-F improvements were maintained to 12 months in tofacitinib-treated patients.
Slovenian: V preskušanjih ORAL Standard in ORAL Scan so se povprečna izboljšanja FACIT-F pri bolnikih, ki so prejemali tofacitinib, ohranila do 12 mesecev.
English: In OPAL BROADEN, Minimal Disease Activity (MDA) response was achieved by 26.2%, 25.5% and 6.7% of tofacitinib 5 mg BID, adalimumab and placebo treated patients, respectively (tofacitinib 5 mg BID treatment difference from placebo 19.5% [95% CI: 9.9, 29.1]) at month 3.
Slovenian: V preskušanju OPAL BROADEN je odziv, opredeljen kot minimalna aktivnost bolezni (MDAMinimal Disease Activity), po 3 mesecih doseglo 26,2 % bolnikov, zdravljenih s 5 mg tofacitiniba dvakrat na dan, 25,5 % bolnikov, zdravljenih z adalimumabom, in 6,7 % bolnikov, zdravljenih s placebom (razlika med zdravljenjem s 5 mg tofacitiniba dvakrat na dan in placebom je bila 19,5 % [95 % IZ: 9,9; 29,1]).
English: Statistically significant ACR20 response rates were observed with tofacitinib 5 mg BID in both studies as early as week 2 (first post-baseline assessment) in comparison to placebo.
Slovenian: Statistično značilne stopnje odziva ACR20 v primerjavi s placebom so pri zdravljenju s 5 mg tofacitiniba dvakrat na dan v obeh preskušanjih opazili že 2. teden (ob prvem ocenjevanju po izhodiščnem).
English: It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Slovenian: Odmerjanja ni priporočljivo uvesti pri bolnikih z absolutnim številom nevtrofilcev (ANC - Absolute Neutrophil Count), manjšim od 1.000 celic/mm
English: In ORAL Standard and ORAL Scan, mean improvements in both scales were maintained to 12 months in tofacitinib-treated patients.
Slovenian: V preskušanjih ORAL Standard in ORAL Scan so se povprečna izboljšanja na obeh lestvicah pri bolnikih, ki so prejemali tofacitinib, ohranila do 12 mesecev.
English: How to take XELJANZ
Slovenian: Kako jemati zdravilo XELJANZ
English: • Tofacitinib monotherapy
Slovenian: • monoterapija s tofacitinibom
English: Time of mandatory placebo rescue to tofacitinib 5 mg or 10 mg twice daily
Slovenian: Čas obveznega rešilnega prehoda s placeba na tofacitinib 5 mg ali 10 mg dvakrat na dan
English: It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm
Slovenian: Odmerjanja ni priporočljivo uvesti pri bolnikih z absolutnim številom limfocitov (ALC - Absolute Lymphocyte Count), manjšim od 750 celic/mm
English: mTSSc Baseline Month 6 Month 12
Slovenian: mTSSc izhodišče 6. mesec 12. mesec
English: You can start the Xeljanz 11 mg prolonged-release tablets once daily the day following the last dose of XELJANZ 5 mg film-coated tablets.
Slovenian: Zdravilo XELJANZ 11 mg tablete s podaljšanim sproščanjem lahko začnete jemati naslednji dan po zadnjem odmerku zdravila XELJANZ 5 mg filmsko obloženih tablet.
English: In the randomised 52-week phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group.
Slovenian: V randomiziranem 52-tedenskem preskušanju vzdrževalnega zdravljenja 3. faze je bil delež bolnikov z okužbami 35,9 % (71 bolnikov) v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan, in 39,8 % (78 bolnikov) v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan, v primerjavi s 24,2 % (48 bolnikov) v skupini, ki je prejemala placebo.
English: XELJANZ is not recommended for use with medicines that depress the immune system, including so-called targeted biologic (antibody) therapies, such as those that inhibit tumour necrosis factor, interleukin-17, interleukin-12/interleukin-23, anti-integrins, and strong chemical immunosuppressants including azathioprine, mercaptopurine, ciclosporine, and tacrolimus.
Slovenian: Zdravila XELJANZ ni priporočljivo uporabljati skupaj z zdravili, ki zavirajo imunski sistem, vključno s tako imenovanimi tarčnimi biološkimi (protitelesi) zdravljenji, kot so tista za zaviranje tumorje nekrotizirajočega faktorja, interlevkini-17 in interevkini-12/interlevkini-23, antagonisti integrinov in močnimi kemičnimi imunosupresivi, vključno z azatioprinom, merkaptopurinom, ciklosporinom in takrolimusom.
English: Table 18: Proportion of patients meeting primary and key secondary efficacy endpoints at week 52 by TNF inhibitor therapy subgroup (OCTAVE sustain, central endoscopy read)
Slovenian: Preglednica 18: Delež bolnikov, pri katerih so po 52 tednih potrdili primarni in ključna sekundarna opazovana dogodka učinkovitosti, po posameznih podskupinah, ločenih glede na zdravljenje z zaviralcem TNF (OCTAVE Sustain, centraliziran pregled endoskopskih posnetkov)
English: Table 1: Low absolute lymphocyte count Low absolute lymphocyte count (ALC) (see section 4.4)
Slovenian: Preglednica 1: Majhno absolutno število limfocitov Majhno absolutno število limfocitov (ALC) (glejte poglavje 4.4) Laboratorijska vrednost (celic/mm
English: Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
Slovenian: Če se pri bolniku pojavi resna okužba, oportunistična okužba ali sepsa, je treba zdravljenje prekiniti.
English: In studies of 6-, 12-, or 24-month duration, the rates of serious infections in the 5 mg twice daily and 10 mg twice daily tofacitinib plus DMARD groups were 3.6 and 3.4 patients with events per 100 patient-years, respectively, compared to 1.7 patients with events per 100 patient-years in the placebo plus DMARD group.
Slovenian: V 6-, 12- ali 24-mesečnih preskušanjih je bila stopnja resnih okužb 3,6 bolnika z dogodki na 100 bolnikov-let v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan in DMARD, in 3,4 bolnika z dogodki na 100 bolnikov-let v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan in DMARD, v primerjavi z 1,7 bolnika z dogodki na 100 bolnikov-let v skupini, ki je prejemala placebo in DMARD.
English: Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open).
Slovenian: Odprto podaljšano preskušanje (OCTAVE Open) Bolniki, ki v enem od preskušanj indukcijskega zdravljenja (OCTAVE Induction 1 ali OCTAVE Induction 2) po 8 tednih zdravljenja z 10 mg tofacitiniba dvakrat na dan niso dosegli kliničnega odziva, so lahko sodelovali v odprtem podaljšanem preskušanju (OCTAVE Open).
English: With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Slovenian: brez predhodnega neučinkovitega zdravljenja z zaviralcem TNF izboljšanje endoskopskega videza sluznice predhodno neučinkovito zdravljenje z zaviralcem TNF 11/89
English: A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalisation of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
Slovenian: Tako v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan, kot v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan, so po 52 tednih pri pomembno večjem deležu bolnikov kot v skupini s placebom potrdili naslednje opazovane dogodke: remisijo, izboljšanje endoskopskega videza sluznice, normalizacijo endoskopskega videza sluznice, ohranitev kliničnega odziva, remisijo pri bolnikih, ki so bili ob izhodišču v remisiji, in ohranjeno remisijo brez jemanja kortikosteroidov po 24 in 52 tednih pri bolnikih, ki so bili ob izhodišču v remisiji, kot je prikazano v preglednici 17.
English: 6 months 2 years
Slovenian: 6 mesecev 1 leto
English: Certain types of vaccines should not be given when taking XELJANZ.
Slovenian: Med zdravljenjem z zdravilom XELJANZ bolniki ne smejo prejeti nekaterih vrst cepiv.
English: The most common serious infections reported with tofacitinib were pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis.
Slovenian: Najpogostejše resne okužbe, o katerih so poročali pri zdravljenju s tofacitinibom, so vključevale pljučnico, celulitis, herpes zoster, okužbe sečil, divertikulitis in apendicitis.
English: Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol (including increased LDL), weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, joint sprain, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): tuberkuloza, okužba ledvic, okužba kože, herpes simpleks ali razjede zaradi herpesa (ustni herpes), zmanjšanje števila belih krvnih celic, zvečanje vrednosti jetrnih encimov v krvi (znak težav z jetri), zvečanje vrednosti kreatinina v krvi (možen znak težav z ledvicami), zvečan holesterol (vključno z zvečanjem holesterola LDL), zvečanje telesne mase, dehidracija, nateg mišic, bolečine v mišicah in sklepih, vnetje tetiv, otekanje sklepov, zvin sklepa, nenormalni občutki, težave s spanjem, zamašenost sinusov, kratka sapa ali težave z dihanjem, rdečina na koži, srbenje, zamaščena jetra, boleče vnetje majhnih žepkov na sluznici črevesja (divertikulitis), virusne okužbe, virusne okužbe, ki prizadenejo črevesje, nekatere vrste kožnega raka (nemelanomski kožni rak).
English: For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted until ALC is greater than 750.
Slovenian: Pri vztrajnem (2 zaporedni vrednosti v tem razponu pri rutinskem testiranju) zmanjšanju v tem razponu je treba odmerjanje zmanjšati ali prekiniti, dokler ni ALC večje od 750.
English: Dose adjustment No dose adjustment is required when used in combination with MTX.
Slovenian: Prilagajanje odmerka Pri uporabi v kombinaciji z MTX prilagajanje odmerka ni potrebno.
English: Your doctor may reduce the dose if you have liver or kidney problems or if you are prescribed certain other medicines.
Slovenian: Če imate težave z jetri ali ledvicami ali če so vam predpisali nekatera druga zdravila, vam bo zdravnik morda zmanjšal odmerek.
English: In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patient-years, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
Slovenian: V skupini, ki je prejemala monoterapijo z 10 mg tofacitiniba dvakrat na dan, je bila stopnja 1,6 bolnika z dogodki na 100 bolnikov-let, v skupini, ki je prejemala placebo, je bila stopnja 0 dogodkov na 100 bolnikov-let, v skupini, ki je prejemala MTX, pa je bila stopnja 1,9 bolnika z dogodki na 100 bolnikov-let.
English: In the controlled RA clinical studies, confirmed decreases in ANC below 1,000 cells/mm3 occurred in 0.08% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Slovenian: V nadzorovanih kliničnih preskušanjih pri bolnikih z RA so zmanjšanje ANC pod 1.000 celic/mm potrdili pri skupno 0,08 % bolnikov v skupinah, ki sta prejemali odmerke 5 mg dvakrat na dan in 10 mg dvakrat na dan.
English: XELJANZ 10 mg film-coated tablets XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Slovenian: XELJANZ 10 mg filmsko obložene tablete XELJANZ 10 mg filmsko obložene tablete so modre in okrogle.
English: The recommended dose is 5 mg administered twice daily.
Slovenian: Priporočeni odmerek je 5 mg dvakrat na dan.