FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
Slovak: V klinických skúšaniach sa tofacitinib nehodnotil u pacientov so vstupnými hodnotami klírens kreatinínu (odhadnuté podľa Cockroft
English: Dose Adjustment
Slovak: Úprava dávkovania
English: Nominal p≤0.05;
Slovak: * Nominálne p ≤
English: N Month 3
Slovak: N 3. mesiac
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.
Slovak: 25 mg), pričom dávka kortikosteroidov sa postupne znižovala až sa povinne vysadili do 15 týždňov od vstupu do štúdie s udržiavacou liečbou.
English: Gastritis Dyspepsia
Slovak: Nauzea Gastritída
English: 1.3% of patients and for ALC between 500 and 750 cells/mm3 in 8.4% of patients for the 5 mg twice daily and 10 mg twice daily doses combined.
Slovak: % pacientov a v ALC medzi 500 a 750 buniek/mm3 u 8,4
English: • The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Slovak: Pokyny pre zdravotníckych pracovníkov majú obsahovať nasledujúce kľúčové prvky: o Relevantné informácie o obavách o bezpečnosť, ktorými sa zaoberajú opatrenia na minimalizáciu rizík (aRMM) (napr. závažnosť, vážnosť, frekvencia, čas do nástupu ochorenia, reverzibilita NÚ, ak sa vyskytnú) o Detaily o populácii, ktorá je vo zvýšenom riziku obavy o bezpečnosť, ktorou sa zaoberajú opatrenia na minimalizáciu rizík (aRMM) (t.j. kontraindikácie, rizikové faktory, zvýšené riziko interakcií s určitým liečivom)
English: The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Slovak: tofacitinibu sa odhaduje na približne 27 %.
English: ALC greater than or equal to 750
Slovak: Odporúčanie ALC vyšší alebo rovný 750 Dávkovanie sa musí zachovať.
English: Maintenance of clinical responsed
Slovak: Pretrvávanie klinickej odpoveded
English: With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Slovak: Bez predchádzajúceho zlyhania TNF inhibítorab
English: In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis.
Slovak: Ak sa XELJANZ užíval pri reumatoidnej artritíde samotný, pozorovalo sa vo všeobecnosti menej vedľajších účinkov.
English: - if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
Slovak: - ak máte vysoké riziko vzniku rakoviny kože, lekár vám môže počas užívania XELJANZU odporučiť pravidelné kontroly kože - ak ste mali divertikulitídu (určitý typ zápalu hrubého čreva) alebo žalúdočné vredy či vredy v čreve (pozri časť 4)
English: In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
Slovak: V predklinických štúdiách boli pozorované účinky tofacitinibu na imunitný a hematopoetický systém,
English: ORAL Standard: MTX Inadequate Responders
Slovak: ORAL Standard: Pacienti s nedostatočnou odpoveďou na MTX
English: Prior TNFi failure Prior corticosteroid failure
Slovak: Predchádzajúce zlyhanie TNFi
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.
Slovak: 59 pre placebo, N = 65 pre tofacitinib 5 mg dvakrát denne, N =
English: AUC Cmax
Slovak: Cmax
English: Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Slovak: Každá 5 mg filmom obalená tableta obsahuje tofacitinib citrát zodpovedajúci 5 mg tofacitinibu.
English: b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Slovak: Nedostatočná odpoveď na aspoň 1 TNFi v dôsledku nedostatočnej účinnosti a/alebo intolerancie.
English: Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Slovak: Každá 10 mg filmom obalená tableta obsahuje tofacitinib citrát zodpovedajúci 10 mg tofacitinibu.
English: In the controlled portion of the RA Phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
Slovak: V kontrolovanej časti RA štúdie fázy 3 s monoterapiou (0 - 3 mesiace) (štúdia I, pozri časť 5.1) zvýšenia ALT vyššie ako 3 x ULN boli pozorované u 1,65 % pacientov dostávajúcich placebo, u 0,41
English: a Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Slovak: Dávkovanie tofacitinibu sa musí znížiť na 5 mg dvakrát denne u pacientov užívajúcich 10 mg dvakrát denne.
English: Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
Slovak: Pacienti s nedostatočnou odpoveďou na klasický syntetický DMARD a (neliečení TNFi)
English: HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
Slovak: HDPE fľaše so silikagélovým vysúšadlom a uzávermi zabezpečenými pred deťmi obsahujúce
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
Slovak: NÁZOV LIEKU XELJANZ 10 mg tablety tofacitinib
English: Placebo Tofacitinib 5 mg Twice Daily
Slovak: Placebo Tofacitinib 5 mg dvakrát denne
English: Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Slovak: Induction 2) pri liečbe tofacitinibom 10 mg dvakrát denne, u ktorých ale došlo k zlyhaniu liečby potom, ako sa dávka znížila na tofacitinib 5 mg dvakrát denne alebo po prerušení liečby v skúšaní OCTAVE
English: Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Slovak: Nízka hladina hemoglobínu (časť 4.4)
English: Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Slovak: Tofacitinib sa neskúmal a nesmie sa používať v kombinácii s biologickými liekmi ako sú napr. antagonisty TNF, antagonisty interleukínu (IL)-1R, antagonisty IL-6R, monoklonálne protilátky anti
English: • The patient information pack should contain: o Patient information leaflet o The patient alert card
Slovak: Písomná informácia pre používateľa o Bezpečnostná karta pacienta
English: Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Slovak: - ak máte problémy s pečeňou - ak máte alebo ste mali hepatitídu typu B alebo hepatitídu typu C (vírusy postihujúce pečeň).
English: Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
Slovak: 1 bod alebo subskóre krvácania z konečníka 0 alebo 1.
English: Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND
Slovak: Tabuľka 13: Zmena v HAQ-DI oproti východiskovému stavu v štúdiách OPAL BROADEN a OPAL BEYOND u pacientov s PsA Priemerná zmena metódou najmenších štvorcov v HAQ-DI oproti východiskovému stavu
English: Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
Slovak: Infekcia atypickými mykobaktériami
English: Placebo Tofacitinib 10 mg Twice Daily
Slovak: Placebo Tofacitinib 10 mg dvakrát denne
English: Tofacitinib 10 mg Twice Daily Monotherapy N=243
Slovak: Tofacitinib 10 mg dvakrát denne ako monoterapia N = 242
English: Improvement of endoscopic appearance of the mucosa
Slovak: Zlepšenie vzhľadu sliznice pri endoskopiic
English: Table 8: Proportion (%) of Patients with an ACR Response ORAL Solo: DMARD Inadequate Responders
Slovak: ORAL Solo: Pacienti s nedostatočnou odpoveďou na DMARD
English: a SD = Standard Deviation b Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval) c Month 6 and month 12 data are mean change from baseline d Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Slovak: Rozdiel medzi priemermi najmenších štvorcov tofacitinibu mínus placebo (95 % CI = interval spoľahlivosti 95 %)
English: TNFi Inadequate Respondersb
Slovak: Pacienti s nedostatočnou odpoveďou na TNFib
English: in studies OPAL BROADEN and OPAL BEYOND was 53% and 50%, respectively in patients receiving tofacitinib 5 mg twice daily, 31% and 28%, respectively in patients receiving placebo, and 53% in patients receiving adalimumab 40 mg subcutaneously once every 2 weeks (OPAL BROADEN only).
Slovak: 0,35) v 3. mesiaci v štúdiách OPAL BROADEN bol 53 % a OPAL BEYOND 50 % u pacientov dostávajúcich tofacitinib 5 mg dvakrát denne, 31
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
Slovak: NÁZOV LIEKU XELJANZ 5 mg tablety tofacitinib
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
Slovak: ŠKATUĽA NA 10 MG BLISTROVÉ BALENIE
English: • skin blisters
Slovak: STRIPOCH BLISTRE
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.
Slovak: herpes zoster, tuberkulózy (TBC) a iných oportúnnych infekcií, malignít, gastrointestinálnych perforácií, intersticiálnej choroby pľúc a laboratórnych abnormalít.
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.
Slovak: V kontrolovanej časti RA štúdie fázy 3 so základnou liečbou DMARD (0 - 3 mesiace) (štúdia II - V, pozri časť 5.1) zvýšenia ALT vyššie ako 3 x ULN boli pozorované u 0,9 % pacientov dostavajúcich placebo, u 1,24
English: Tofacitinib 5 mg Twice Daily + MTX
Slovak: Tofacitinib 5 mg dvakrát denne + MTX
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
Slovak: EU/1/17/1178/007 56 filmom obalených tabliet EU/1/17/1178/008 112 filmom obalených tabliet EU/1/17/1178/009 182 filmom obalených tabliet
English: Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
Slovak: Tofacitinib 10 mg dvakrát denne + MTX priemerný rozdiel v porovnaní s placebomb
English: a. ≤3 weekly doses (MTX-naïve).
Slovak: ≤ 3-týždňové dávky (bez predchádzajúcej liečby MTX).
English: Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
Slovak: Tabuľka 14: Klinické štúdie fázy 3 pre dávky tofacitinibu 5 a 10 mg dvakrát denne u pacientov s ulceróznou kolitídou OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
Slovak: EU/1/17/1178/003 56 filmom obalených tabliet EU/1/17/1178/004 182 filmom obalených tabliet EU/1/17/1178/014 112 filmom obalených tabliet
English: Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI)
Slovak: Tofacitinib 10 mg dvakrát denne priemerný rozdiel v porovnaní s MTXd
English: Tofacitinib 5 mg Twice Daily + DMARD(s)
Slovak: Tofacitinib 5 mg dvakrát denne + DMARD
English: Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
Slovak: Tofacitinib 5 mg dvakrát denne priemerný rozdiel v porovnaní s MTXd
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
Slovak: LIEKOVÁ FORMA A OBSAH 56 filmom obalených tabliet 112 filmom obalených tabliet 182 filmom obalených tabliet
English: BID=twice daily.
Slovak: 5 mg dvakrát denne.
English: Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer.
Slovak: ale bez obmedzenia, rakoviny pľúc, rakoviny prsníka, melanómu, rakoviny prostaty a rakoviny pankreasu.
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.
Slovak: V kontrolovaných klinických štúdiách RA sa potvrdené poklesy ANC pod 1 000 buniek/mm3 vyskytli u 0,08
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).
Slovak: V kontrolovaných klinických štúdiách fázy 3 so základnou liečbou DMARD bol podiel infekcií počas 0 - 3 mesiacov v skupine tofacitinibu 5 mg dvakrát denne v kombinácii s DMARD (celkom 973 pacientov) a 10 mg dvakrát denne v kombinácii s DMARD (celkom 969 pacientov)
English: MTX N=168 Mean (SD)
Slovak: 168 Priemer (SD)a
English: Impairment
Slovak: Svrbenie
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).
Slovak: 0,05) oproti východiskovým hodnotám v porovnaní s placebom v 3. mesiaci (pozri tabuľku 13).
English: TNFi Inadequate Responders b
Slovak: SD = smerodajná odchýlka b
English: XELJANZ is a medicine that contains the active substance tofacitinib.
Slovak: Čo je XELJANZ a na čo sa používa XELJANZ je liek, ktorý obsahuje liečivo tofacitinib.
English: Interstitial lung disease
Slovak: • malígne nádorové ochorenie
English: NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
Slovak: XELJANZ 5 mg filmom obalené tablety XELJANZ 10 mg filmom obalené tablety
English: 180 film-coated tablets
Slovak: 60 alebo 180 filmom obalených tabliet.
English: Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Slovak: (%) účastníkov dosahujúcich remisiu podľa DAS28-4(FW) <
English: d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE
Slovak: Pacientom, ktorí dosiahli klinickú odpoveď v 1 zo štúdie s indukčnou liečbou (OCTAVE Induction 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
Slovak: EU/1/17/1178/005 60 filmom obalených tabliet EU/1/17/1178/006 180 filmom obalených tabliet
English: c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Slovak: c Celkovo dosiahnutá štatistická významnosť pri p ≤
English: d. Clinical response was defined as a decrease from baseline in Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the subscore for rectal bleeding of ≥ 1 point or absolute subscore for rectal bleeding of 0 or 1.
Slovak: Pretrvávanie klinickej odpovede bolo definované ako pokles východiskového Mayo skóre o ≥ 3 body a ≥
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING
Slovak: PRE VNÚTORNÝ OBAL FĽAŠE PRE 10 MG
English: In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission,
Slovak: Oproti placebu dosiahol vyšší podiel pacientov v oboch podskupinách, či už s predchádzajúcim zlyhaním inhibítora TNF, alebo bez predchádzajúceho zlyhania inhibítora TNF, liečených buď tofacitinibom 5 mg dvakrát denne, alebo tofacitinibom 10 mg dvakrát denne nasledujúce cieľové ukazovatele v 52. týždni skúšania OCTAVE Sustain: remisia, zlepšenie vzhľadu sliznice pri endoskopii alebo pretrvávanie remisie bez kortikosteroidov, tak v 24. týždni, ako aj v 52. týždni, z pacientov, ktorí boli pri vstupe do skúšania v remisii (Tabuľka 18).
English: Tofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see section 5.1).
Slovak: u dospelých pacientov, ktorí nedostatočne odpovedajú na predchádzajúcu liečbu choroby modifikujúcim antireumatickým liekom (DMARD, disease-modifying antirheumatic drug), alebo ktorí ju netolerujú (pozri časť 5.1).
English: Tofacitinib Twice Daily + MTX
Slovak: Tofacitinib dvakrát denne + MTX
English: Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
Slovak: XELJANZ 5 mg filmom obalené tablety XELJANZ 10 mg filmom obalené tablety tofacitinib
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
Slovak: Tabuľka 15: Podiel pacientov, ktorí dosiahli ukazovatele účinnosti v 8. týždni (štúdie OCTAVE
English: 1 year
Slovak: 2 roky
English: What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
Slovak: XELJANZ 5 mg filmom obalená tableta je biela a okrúhla.
English: • The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening of the patient o Vaccination course to be completed before treatment o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
Slovak: Potreba pozhovárať sa s pacientmi o rizikách spojených s užívaním XELJANZU, najmä s ohľadom na infekcie, herpes zoster, tuberkulózu (TBC) a iné oportúnne infekcie, malignity, gastrointestinálne perforácie, intersticiálnu chorobu pľúc a laboratórne abnormality o Potreba sledovať akékoľvek prejavy a príznaky a laboratórne abnormality kvôli včasnej identifikácii vyššie uvedených rizík.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Slovak: EU/1/17/1178/001 60 filmom obalených tabliet EU/1/17/1178/002 180 filmom obalených tabliet
English: Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
Slovak: U pacientov dostávajúcich tofacitinib 5 alebo 10 mg dvakrát denne sa v skúšaniach ORAL Sync, ORAL Standard a ORAL
English: What XELJANZ contains
Slovak: Obsah balenia a ďalšie informácie Čo XELJANZ obsahuje
English: Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
Slovak: dostávali 40 mg subkutánne každé 2 týždne počas 12 mesiacov.
English: It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Slovak: Neodporúča sa začať liečbu tofacitinibom u pacientov s ANC nižším ako
English: Rheumatoid arthritis • The recommended dose is 5 mg twice a day.
Slovak: Odporúčaná dávka je 5 mg dvakrát denne.
English: Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily.
Slovak: Dávkovanie sa musí znížiť na 5 mg dvakrát denne, keď je pri normálnej funkcii pečene indikované dávkovanie
English: Dose should be reduced to 5 mg once daily when the indicated dose in the presence of normal renal function is 5 mg twice daily.
Slovak: Dávkovanie sa musí znížiť na 5 mg jedenkrát denne, keď je pri normálnej funkcii obličiek indikované dávkovanie
English: Hepatic impairment
Slovak: Stearát horečnatý
English: Tofacitinib 10 mg Twice Daily Monotherapy N=394
Slovak: Tofacitinib 10 mg dvakrát denne ako monoterapia N =
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
Slovak: ŠKATUĽA NA 5 MG BLISTROVÉ BALENIE
English: Tofacitinib 5 mg Twice Daily Monotherapy N=370
Slovak: Tofacitinib 5 mg dvakrát denne ako monoterapia N =
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Slovak: Každá tableta obsahuje 10 mg tofacitinibu (ako tofacitinib citrát).
English: Both TNF inhibitor naïve and TNF inhibitor inadequate responder tofacitinib 5 mg BID -treated patients had significantly higher ACR20 response rates compared to placebo at month 3.
Slovak: liečení tofacitinibom 5 mg dvakrát denne mali významne vyššie miery odpovede ACR20 v porovnaní s placebom v 3. mesiaci.
English: Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI)
Slovak: Tofacitinib 5 mg dvakrát denne + MTX priemerný rozdiel v porovnaní s placebomb
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Slovak: 0,001; *** Nominálne p <
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 5 MG BOTTLE IMMEDIATE PACKAGING
Slovak: PRE VNÚTORNÝ OBAL FĽAŠE PRE 5 MG
English: Signs and symptoms
Slovak: Klinické a subjektívne príznaky
English: Tofacitinib 5 mg Twice Daily N=198
Slovak: 101 pre tofacitinib 5 mg dvakrát denne, N =
English: X-Ray
Slovak: MTX-IR
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Slovak: Každá tableta obsahuje 5 mg tofacitinibu (ako tofacitinib citrát).