FrancophonIA/ELRC3.0 huggingface dataset:
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 obvladana.
English: How to Take XELJANZ
Slovenian: Kako jemati zdravilo XELJANZ
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: Month 6 ORAL Standard: MTX Inadequate Responders Tofacitinib 5 mg twice daily + MTX
Slovenian: 6. mesec ORAL Standard: bolniki z nezadostnim odzivom na MTX tofacitinib 5 mg dvakrat na dan + MTX
English: Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužba pljuč (pljučnica in bronhitis), pasovec (herpes zoster), okužbe nosu, žrela ali sapnika (nazofaringitis), gripa, sinuzitis, okužba sečnega mehurja (cistitis), vnetje žrela (faringitis), zvečanje vrednosti mišičnih encimov v krvi (znaki težav z mišicami), bolečine v želodcu (trebuhu) (ki so lahko posledica vnetja želodčne sluznice), bruhanje, driska, občutek siljenja na bruhanje (navzea), prebavne motnje, zvin sklepa, zmanjšanje števila rdečih krvnih celic (anemija), vročina, utrujenost, otekanje stopal in dlani, glavobol, zvišan krvni tlak (hipertenzija), kašelj, izpuščaj.
English: Table 4: Dose Adjustment for Hepatic Impairment Hepatic
Slovenian: Preglednica 4: Prilagajanje odmerka pri okvari jeter Okvara jeter Razvrstitev
English: *** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Slovenian: p < 0,0001, tofacitinib v primerjavi s placebom + MTX, **** eno ali več DMARD, n = število bolnikov, NA = ni na voljo, HAQ-DI = indeks oviranosti po vprašalniku za oceno zdravstvenega stanja
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Slovenian: Remisijo so opredelili kot klinična remisija (celokupna ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using XELJANZ o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19
Slovenian: • Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila: o opozorilo za zdravstvene delavce, ki kadarkoli zdravijo bolnika (tudi v urgentnih okoliščinah), da bolnik jemlje zdravilo XELJANZ; o da lahko zdravljenje z zdravilom XELJANZ zveča tveganje za okužbe in nemelanomskega kožnega raka; o da mora bolnik zdravstvenega delavca obvestiti, če načrtuje prejem kateregakoli cepiva ali zanositev; o znake in simptome navedenih pomislekov glede varnosti in kdaj poiskati pomoč pri zdravstvenem delavcu: okužbe; reaktivacija herpes zostra; nemelanomski kožni rak; zvečane vrednosti transaminaz in možnost z zdravilom povzročene poškodbe jeter; perforacija prebavil; intersticijska pljučna bolezen; zvečana imunosupresija pri uporabi v kombinaciji z biološkimi zdravili in imunosupresivi, vključno z učinkovinami za zmanjšanje števila limfocitov B; povečano tveganje za neželene učinke, kadar je zdravilo XELJANZ
English: Τηλ: +30 210 67 85 800
Slovenian: PFIZER ΕΛΛΑΣ A.E. Τηλ: +30 210 67 85 800
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: 70% improvement; csDMARD=conventional synthetic disease-modifying antirheumatic drug; N=number of randomised and treated patients; NA=Not applicable, as data for placebo treatment is not available beyond month 3 due to placebo advanced to tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor; PASI=Psoriasis Area and
Slovenian: Okrajšave: BSA = telesna površina (Body Surface Area); ΔLEI = sprememba Leedsovega indeksa entezitisa (LEI - Leeds Enthesitis Index) od izhodišča; ΔDSS = sprememba ocene izraženosti daktilitisa (DSSDactylitis Severity Score) od izhodišča; ACR20/50/70 = izboljšanja za ≥ 20 %, ≥ 50 %, ≥ 70 % po merilih ACR; csDMARD = običajno sintetično imunomodulirajoče antirevmatično zdravilo; n = število randomiziranih in zdravljenih bolnikov; NA = ni na voljo, ker podatki za zdravljenje s placebom od 3. meseca dalje niso na voljo, saj so bolnike s placeba prerazporedili na bodisi 5 mg tofacitiniba dvakrat na dan bodisi 10 mg tofacitiniba dvakrat na dan; SC q2w = subkutano enkrat na 2 tedna; TNF = tumorje nekrotizirajoči faktor; PASI = indeks površine in izrazitosti psoriaze (Psoriasis Area and Severity Index); PASI75 = izboljšanje PASI za ≥ 75 %.
English: Talk to your doctor or pharmacist before taking XELJANZ: - if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired - if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system) - if you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back.
Slovenian: Pred začetkom jemanja zdravila XELJANZ se posvetujte z zdravnikom ali farmacevtom: - če mislite, da imate okužbo ali imate simptome okužbe, kot so vročina, znojenje, mrzlica, bolečine v mišicah, kašelj, kratka sapa, nov ali spremenjen izmeček iz dihalnih poti, zmanjšanje telesne mase, topla, rdeča oziroma boleča koža ali razjede na telesu, težave ali bolečine pri požiranju, driska ali bolečine v želodcu, pekoč občutek pri uriniranju ali pogostejše uriniranje kot običajno, občutek hude utrujenosti.
English: N ORAL Step: TNF Inhibitor Inadequate Responders Tofacitinib 5 mg twice daily + MTX
Slovenian: ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF tofacitinib 5 mg dvakrat na dan + MTX
English: Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily
Slovenian: 3. mesec ORAL Sync: bolniki z nezadostnim odzivom na DMARD tofacitinib 5 mg dvakrat na dan
English: Tofacitinib 10 mg Twice Daily Placebo
Slovenian: TOFACITINIB 10 mg dvakrat na dan placebo
English: Tel: +44 (0)1304 616161
Slovenian: United Kingdom Pfizer Limited Tel: +44 (0)1304 616161
English: Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see sections 4.4 and 4.5) as follows:
Slovenian: Pri bolnikih, ki prejemajo močne zaviralce citokroma P450 (CYP) 3A4 (npr. ketokonazol), in pri bolnikih, ki sočasno prejemajo 1 ali več zdravil, ki zmerno zavirajo CYP3A4 in hkrati močno zavirajo CYP2C19 (npr. flukonazol) (glejte poglavji 4.4 in 4.5), je treba skupni dnevni odmerek tofacitiniba zmanjšati za polovico, kot sledi:
English: In the MTX group, 70% of patients experienced no radiographic progression at month 6 compared to 83% and 90% of patients treated with tofacitinib 5 or 10 mg twice daily respectively, both significant versus MTX.
Slovenian: V skupini, ki je prejemala MTX, v 6. mesecu pri 70 % bolnikov bolezen ni radiografsko napredovala v primerjavi s 83 % bolnikov v skupini, ki je prejemala 5 mg tofacitiniba dvakrat na dan, in 90 % bolnikov v skupini, ki je prejemala 10 mg tofacitiniba dvakrat na dan (oba rezultata sta statistično pomembna v primerjavi s skupino, ki je prejemala MTX).
English: Impact of Other Medicinal Products on PK of Tofacitinib
Slovenian: Vpliv drugih zdravil na farmakokinetiko tofacitiniba
English: Table 15: Proportion of Patients Meeting Efficacy Endpoints at Week 8 (OCTAVE Induction Study 1 and OCTAVE Induction Study 2) OCTAVE Induction Study 1 Central Endoscopy Read
Slovenian: Preglednica 15: Delež bolnikov, pri katerih so po 8 tednih potrdili opazovane dogodke učinkovitosti (preskušanje OCTAVE Induction 1 in preskušanje OCTAVE Induction 2)
English: Inadequate response to a least one TNF inhibitor (TNFi) due to lack of efficacy and/or intolerability.
Slovenian: Nezadosten odziv na najmanj 1 zaviralec TNF (TNFi) zaradi nezadostne učinkovitosti in/ali intolerance.
English: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 8 by TNF Inhibitor Therapy Subgroups (OCTAVE Induction Study 1 and OCTAVE Induction Study 2, Central Endoscopy Read) OCTAVE Induction Study 1
Slovenian: Delež bolnikov, pri katerih so po 8 tednih potrdili primarni in ključna sekundarna opazovana dogodka učinkovitosti, po posameznih podskupinah, ločenih glede na zdravljenje z zaviralcem TNF (preskušanje OCTAVE Induction 1 in preskušanje OCTAVE Induction 2, centraliziran pregled endoskopskih posnetkov)
English: Placebo N=122
Slovenian: Opazovani dogodek placebo n = 122
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: Nevtrofilci V nadzorovanih kliničnih preskušanjih pri bolnikih z RA so zmanjšanje absolutnega števila nevtrofilcev (ANC) pod 1.000 celic/mm3 potrdili pri skupno 0,08 % bolnikov za skupini, ki sta prejemali odmerke 5 mg dvakrat na dan in 10 mg dvakrat na dan.
English: In controlled Phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Slovenian: V nadzorovanih kliničnih preskušanjih 3. faze je bila stopnja okužb v 0-3 mesecih 16,2 % (100 bolnikov) v skupini, ki je prejemala monoterapijo s 5 mg tofacitiniba dvakrat na dan (skupno 616 bolnikov), in 17,9 % (115 bolnikov) v skupini, ki je prejemala monoterapijo z 10 mg tofacitiniba dvakrat na dan (skupno 642 bolnikov), v primerjavi z 18,9 % (23 bolnikov) v skupini, ki je prejemala placebo (skupno 122 bolnikov).
English: Non-melanoma skin cancer
Slovenian: nemelanomski kožni rak
English: Month 3 NA
Slovenian: Časovna točka n
English: Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Slovenian: Ena 5 mg filmsko obložena tableta vsebuje tofacitinibijev citrat v količini, ki ustreza 5 mg tofacitiniba.
English: b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Slovenian: b Nezadosten odziv na najmanj 1 antagonist TNF zaradi nezadostne učinkovitosti in/ali intolerance.
English: In the controlled RA clinical studies, confirmed decreases in ALC below 500 cells/mm3 occurred in 0.3% of patients and for ALC between 500 and 750 cells/mm3 in 1.9% 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 ALC pod 500 celic/mm3 potrdili pri skupno 0,3 % bolnikov, zmanjšanje ALC med 500 in 750 celic/mm3 pa pri skupno 1,9 %
English: Patients receiving tofacitinib 5 mg twice daily demonstrated a greater improvement in arthritis pain (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Slovenian: V preskušanjih OPAL BROADEN in OPAL BEYOND so pri bolnikih, ki so prejemali 5 mg tofacitiniba dvakrat na dan, od 2. tedna (prvega ocenjevanja po izhodiščnem) do 3. meseca opažali večje izboljšanje artritične bolečine (izmerjene po vizualni analogni lestvici 0-100) od izhodišča v primerjavi s placebom (nominalna vrednost p ≤ 0,05).
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Slovenian: Možnost vpliva tofacitiniba na farmakokinetiko drugih zdravil Sočasna uporaba tofacitiniba pri zdravih prostovoljkah ni imela vpliva na farmakokinetiko peroralnih kontraceptivov, levonorgestrela in etinilestradiola.
English: Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Slovenian: Ena 10 mg filmsko obložena tableta vsebuje tofacitinibijev citrat v količini, ki ustreza 10 mg tofacitiniba.
English: d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE
Slovenian: Odprto podaljšano preskušanje (OCTAVE Open) Bolniki, ki v enem od preskušanj indukcijskega zdravljenja (OCTAVE Induction 1 ali OCTAVE
English: CYP3A & CYP2C19 Inhibitor Fluconazole
Slovenian: AUC Cmax zaviralec CYP3A4 ketokonazol zaviralec CYP3A in CYP2C19 flukonazol induktor CYP rifampicin metotreksat takrolimus ciklosporin
English: 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: Hibernomas (malignancy of brown adipose tissue) were observed in female rats at exposures greater than or equal to 83 or 41 times the clinical exposure level at 5 mg or 10 mg twice daily.
Slovenian: Pri samicah podgan so pri izpostavljenostih, ki so bile enake ali večje od 83-kratne oziroma 41-kratne ravni klinične izpostavljenosti pri odmerku 5 mg oziroma 10 mg dvakrat na dan, opazili hibernome (maligno bolezen rjavega maščobnega tkiva).
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, skladno z veljavnimi smernicami, je treba bolnike pregledati ter testirati glede latentne ali aktivne okužbe.
English: NA ORAL Step: TNF Inhibitor Inadequate Responders
Slovenian: NA ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
English: In controlled Phase 3 clinical studies with background DMARDs, the rates of infections over 0-3 months in the 5 mg twice daily (total 973 patients) and 10 mg twice daily (total 969 patients) tofacitinib plus DMARD group were 21.3% (207 patients) and 21.8% (211 patients), respectively, compared to 18.4% (103 patients) in the placebo plus DMARD group (total 559 patients).
Slovenian: V nadzorovanih kliničnih preskušanjih 3. faze, v katerih so bolniki prejemali osnovno zdravljenje z DMARD, je bila stopnja okužb v 0-3 mesecih 21,3 % (207 bolnikov) v skupini, ki je prejemala 5 mg tofacitiniba in DMARD dvakrat na dan (skupno 973 bolnikov), in 21,8 % (211 bolnikov) v skupini, ki je prejemala 10 mg tofacitiniba in DMARD dvakrat na dan (skupno 969 bolnikov), v primerjavi z 18,4 % (103 bolniki) v skupini, ki je prejemala placebo in DMARD (skupno 559 bolnikov).
English: Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
Slovenian: a tofacitinib 10 mg dvakrat na dan + MTX povprečna razlika glede na placebob
English: Placebo + MTX N=132
Slovenian: Opazovani dogodek Čas placebo + MTX n = 132
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
Slovenian: IME ZDRAVILA XELJANZ 10 mg tablete tofacitinib
English: ACR20 Month 3 Month 6
Slovenian: ACR20 3. mesec 6. mesec
English: Tofacitinib 10 mg Twice Daily N=476
Slovenian: tofacitinib 10 mg dvakrat na dan n = 476
English: Tofacitinib 5 mg Twice Daily N=198
Slovenian: tofacitinib 5 mg dvakrat na dan n = 198
English: Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
Slovenian: Preiskave zvečanje vrednosti kreatin-fosfokinaze v krvi zvečanje vrednosti jetrnih encimov, zvečanje vrednosti transaminaz, nenormalni izvidi testov jetrne funkcije, zvečanje vrednosti gamaglutamiltransferaze, zvečanje vrednosti kreatinina v krvi, zvečanje vrednosti holesterola v krvi, zvečanje vrednosti lipoproteinov nizke gostote, zvečanje telesne mase
English: Table 5: Dose Adjustment for Renal Impairment Renal
Slovenian: Preglednica 5: Prilagajanje odmerka pri okvari ledvic Okvara ledvic Očistek kreatinina Prilagajanje odmerka blaga
English: Tofacitinib 5 mg Twice Daily + DMARD(s)
Slovenian: tofacitinib 5 mg dvakrat na dan + DMARD****
English: ACR50 Month 3 Month 6
Slovenian: ACR50 3. mesec 6. mesec
English: TNFi Inadequate Respondersb
Slovenian: bolniki z nezadostnim odzivom na antagonist TNFb
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
Slovenian: IME ZDRAVILA XELJANZ 5 mg tablete tofacitinib
English: • Malignancy
Slovenian: • malignost,
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section
Slovenian: Uporaba tofacitiniba med nosečnostjo je iz previdnosti kontraindicirana (glejte poglavje 4.3).
English: For patients (total 1,750) on monotherapy, the rates were 48.9 and 41.9 patients with events per 100 patient-years for 5 mg and 10 mg twice daily, respectively.
Slovenian: 1.750), je bila pri odmerku 5 mg dvakrat na dan incidenca 48,9 bolnika z dogodki na 100 bolnikov-let, pri odmerku 10 mg dvakrat na dan pa 41,9 bolnika z dogodki na 100 bolnikov-let.
English: Tofacitinib 10 mg Twice Daily N=197
Slovenian: tofacitinib 10 mg dvakrat na dan n = 197
English: NA ORAL Scan: MTX Inadequate Responders
Slovenian: ORAL Scan: bolniki z nezadostnim odzivom na MTX
English: ACR70 Month 3 Month 6
Slovenian: ACR70 3. mesec 6. mesec
English: In the controlled portion of the RA Phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V nadzorovanem delu preskušanja 3. faze z osnovnim zdravljenjem z DMARD pri bolnikih z RA (0-3 meseci) (Preskušanje II-V, glejte poglavje 5.1), so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 0,9 % bolnikov, ki so prejemali placebo, 1,24 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 1,14 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: Co-primary efficacy endpointsc
Slovenian: Sočasni primarni opazovani dogodki učinkovitosti c
English: Tofacitinib 10 mg Twice Daily N=429
Slovenian: tofacitinib 10 mg dvakrat na dan n = 429
English: 4 weeks prior to the visit at both week 24 and week 52. f. 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.
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 - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Slovenian: Ne jemljite zdravila XELJANZ: - če ste alergični na tofacitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: In the RA Phase 3 monotherapy study (0-24 months) (study VI, see section 5.1), ALT elevations greater than 3x ULN were observed in 7.1%, 3.0%, and 3.0% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovenian: V preskušanju 3. faze z monoterapijo pri bolnikih z RA (0-24 mesecev) (Preskušanje VI, glejte poglavje 5.1) so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 7,1 % bolnikov, ki so prejemali MTX, 3,0 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 3,0 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
English: ORAL Strategy: MTX Inadequate Responders
Slovenian: ORAL Strategy: bolniki z nezadostnim odzivom na MTX
English: inhibitors, effects on pregnancy and foetus, use in breastfeeding, effect on vaccination efficacy and the use of live/attenuated vaccines.
Slovenian: uporabljeno v kombinaciji z MTX; povečana izpostavljenost zdravilu XELJANZ pri sočasni uporabi z zaviralci CYP3A4 in CYP2C19; učinki na nosečnost in plod; uporaba med dojenjem; vpliv na učinkovitost cepljenja in uporaba živih/oslabljenih cepiv; o kontaktne podatke predpisovalca.
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 failure b
Slovenian: remisija a predhodno neučinkovito zdravljenje z zaviralcem TNF brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb izboljšanje endoskopskega videza sluznice c predhodno neučinkovito zdravljenje z zaviralcem TNF brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 56 filmsko obloženih tablet 112 filmsko obloženih tablet 182 filmsko obloženih tablet
English: Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a
Slovenian: tofacitinib 10 mg dvakrat na dan n = 368 povprečje (SD)
English: Tofacitinib 10 mg Twice Daily + DMARD(s) N=315
Slovenian: tofacitinib 10 mg dvakrat na dan + DMARD**** n = 315
English: Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post marketing reports.
Slovenian: Pri bolnikih, ki so tofacitinib prejemali v kliničnih preskušanjih in v obdobju trženja zdravila, so opazili primere pljučne embolije (PE).
English: Tel : + 35621 344610
Slovenian: Vivian Corporation Ltd. Tel: + 35621 344610