natgillin/translations-raw huggingface dataset:
Meningitis cryptococcal Mycobacterium avium complex infection
Mycobacterium avium
How to Take XELJANZ
Ako užívať XELJANZ
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.
Predtým, ako začnete užívať XELJANZ, obráťte sa na svojho lekára alebo lekárnika: - ak si myslíte, že máte infekciu alebo máte príznaky infekcie, ako napríklad horúčka, potenie, zimnica, bolesti svalov, kašeľ, dýchavičnosť, nový hlien alebo zmena hlienu, úbytok telesnej hmotnosti, teplá alebo červená alebo bolestivá koža alebo rany na tele, ťažkosti alebo bolesť pri prehĺtaní, hnačka alebo bolesť žalúdka, pálenie pri močení alebo častejšie močenie, pocit veľkej únavy
The HAQ-DI responder rate (response defined as having decrease from baseline of ≥ 0.35) at month 3
Podiel pacientov s odpoveďou podľa HAQ-DI (odpoveď definovaná ako pokles oproti východiskovej hodnote o ≥
Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Pretrvávajúca remisia bez kortikosteroidov aj v 24. týždni, aj v 52. týždni u pacientov, ktorí boli v remisii pri vstupe do skúšaniad
NA ORAL Scan: MTX Inadequate Responders
ORAL Scan: Pacienti s nedostatočnou odpoveďou na MTX
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).
V kontrolovaných klinických štúdiách fázy 3 bol podiel infekcií počas 0 - 3 mesiacov v monoterapeutických skupinách tofacitinibu 5 mg dvakrát denne (celkom 616 pacientov) a 10 mg dvakrát denne (celkom 642 pacientov) 16,2 % (100 pacientov), resp. 17,9
ORAL Strategy: MTX Inadequate Responders
ORAL Strategy: Pacienti s nedostatočnou odpoveďou na MTX
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Odporúča sa nezačať s dávkovaním u pacientov s absolútnym počtom neutrofilov (ANC) nižším ako
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).
V klinických skúšaniach sa tofacitinib nehodnotil u pacientov so vstupnými hodnotami klírens kreatinínu (odhadnuté podľa Cockroft
Dose Adjustment
Úprava dávkovania
Nominal p≤0.05;
* Nominálne p ≤
N Month 3
N 3. mesiac
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.
25 mg), pričom dávka kortikosteroidov sa postupne znižovala až sa povinne vysadili do 15 týždňov od vstupu do štúdie s udržiavacou liečbou.
Gastritis Dyspepsia
Nauzea Gastritída
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.
% pacientov a v ALC medzi 500 a 750 buniek/mm3 u 8,4
• 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
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)
The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
tofacitinibu sa odhaduje na približne 27 %.
ALC greater than or equal to 750
Odporúčanie ALC vyšší alebo rovný 750 Dávkovanie sa musí zachovať.
Maintenance of clinical responsed
Pretrvávanie klinickej odpoveded
With prior TNF inhibitor failure Without prior TNF inhibitor failureb
Bez predchádzajúceho zlyhania TNF inhibítorab
In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis.
Ak sa XELJANZ užíval pri reumatoidnej artritíde samotný, pozorovalo sa vo všeobecnosti menej vedľajších účinkov.
- if you are at high risk of developing skin cancer, your doctor may recommend that you have regular skin examinations while taking XELJANZ.
- 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)
In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
V predklinických štúdiách boli pozorované účinky tofacitinibu na imunitný a hematopoetický systém,
ORAL Standard: MTX Inadequate Responders
ORAL Standard: Pacienti s nedostatočnou odpoveďou na MTX
Prior TNFi failure Prior corticosteroid failure
Predchádzajúce zlyhanie TNFi
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.
59 pre placebo, N = 65 pre tofacitinib 5 mg dvakrát denne, N =
Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Každá 5 mg filmom obalená tableta obsahuje tofacitinib citrát zodpovedajúci 5 mg tofacitinibu.
b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Nedostatočná odpoveď na aspoň 1 TNFi v dôsledku nedostatočnej účinnosti a/alebo intolerancie.
Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Každá 10 mg filmom obalená tableta obsahuje tofacitinib citrát zodpovedajúci 10 mg tofacitinibu.
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.
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
a Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Dávkovanie tofacitinibu sa musí znížiť na 5 mg dvakrát denne u pacientov užívajúcich 10 mg dvakrát denne.
Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
Pacienti s nedostatočnou odpoveďou na klasický syntetický DMARD a (neliečení TNFi)
HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
HDPE fľaše so silikagélovým vysúšadlom a uzávermi zabezpečenými pred deťmi obsahujúce
NAME OF THE MEDICINAL PRODUCT XELJANZ 10 mg tablets tofacitinib
NÁZOV LIEKU XELJANZ 10 mg tablety tofacitinib
Placebo Tofacitinib 5 mg Twice Daily
Placebo Tofacitinib 5 mg dvakrát denne
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.
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
Table 3: Low Haemoglobin Value Low Haemoglobin Value (Section 4.4)
Nízka hladina hemoglobínu (časť 4.4)
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.
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
• The patient information pack should contain: o Patient information leaflet o The patient alert card
Písomná informácia pre používateľa o Bezpečnostná karta pacienta
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).
- ak máte problémy s pečeňou - ak máte alebo ste mali hepatitídu typu B alebo hepatitídu typu C (vírusy postihujúce pečeň).
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.
1 bod alebo subskóre krvácania z konečníka 0 alebo 1.
Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND
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
Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
Infekcia atypickými mykobaktériami
Placebo Tofacitinib 10 mg Twice Daily
Placebo Tofacitinib 10 mg dvakrát denne
Tofacitinib 10 mg Twice Daily Monotherapy N=243
Tofacitinib 10 mg dvakrát denne ako monoterapia N = 242
Improvement of endoscopic appearance of the mucosa
Zlepšenie vzhľadu sliznice pri endoskopiic
Table 8: Proportion (%) of Patients with an ACR Response ORAL Solo: DMARD Inadequate Responders
ORAL Solo: Pacienti s nedostatočnou odpoveďou na DMARD
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)
Rozdiel medzi priemermi najmenších štvorcov tofacitinibu mínus placebo (95 % CI = interval spoľahlivosti 95 %)
TNFi Inadequate Respondersb
Pacienti s nedostatočnou odpoveďou na TNFib
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).
0,35) v 3. mesiaci v štúdiách OPAL BROADEN bol 53 % a OPAL BEYOND 50 % u pacientov dostávajúcich tofacitinib 5 mg dvakrát denne, 31
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg tablets tofacitinib
NÁZOV LIEKU XELJANZ 5 mg tablety tofacitinib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
ŠKATUĽA NA 10 MG BLISTROVÉ BALENIE
• skin blisters
STRIPOCH BLISTRE
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.
herpes zoster, tuberkulózy (TBC) a iných oportúnnych infekcií, malignít, gastrointestinálnych perforácií, intersticiálnej choroby pľúc a laboratórnych abnormalít.
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.
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
Tofacitinib 5 mg Twice Daily + MTX
Tofacitinib 5 mg dvakrát denne + MTX
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
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
Tofacitinib 10 mg Twice Daily + MTX Mean Difference from Placebob
Tofacitinib 10 mg dvakrát denne + MTX priemerný rozdiel v porovnaní s placebomb
a. ≤3 weekly doses (MTX-naïve).
≤ 3-týždňové dávky (bez predchádzajúcej liečby MTX).
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
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
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
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
Tofacitinib 10 mg Twice Daily Mean Difference from MTXd (CI)
Tofacitinib 10 mg dvakrát denne priemerný rozdiel v porovnaní s MTXd
Tofacitinib 5 mg Twice Daily + DMARD(s)
Tofacitinib 5 mg dvakrát denne + DMARD
Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
Tofacitinib 5 mg dvakrát denne priemerný rozdiel v porovnaní s MTXd
PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
LIEKOVÁ FORMA A OBSAH 56 filmom obalených tabliet 112 filmom obalených tabliet 182 filmom obalených tabliet
BID=twice daily.
5 mg dvakrát denne.
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.
ale bez obmedzenia, rakoviny pľúc, rakoviny prsníka, melanómu, rakoviny prostaty a rakoviny pankreasu.
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.
V kontrolovaných klinických štúdiách RA sa potvrdené poklesy ANC pod 1 000 buniek/mm3 vyskytli u 0,08
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).
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)
MTX N=168 Mean (SD)
168 Priemer (SD)a
Impairment
Svrbenie
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
0,05) oproti východiskovým hodnotám v porovnaní s placebom v 3. mesiaci (pozri tabuľku 13).
TNFi Inadequate Responders b
SD = smerodajná odchýlka b
XELJANZ is a medicine that contains the active substance tofacitinib.
Čo je XELJANZ a na čo sa používa XELJANZ je liek, ktorý obsahuje liečivo tofacitinib.
Interstitial lung disease
• malígne nádorové ochorenie
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
XELJANZ 5 mg filmom obalené tablety XELJANZ 10 mg filmom obalené tablety
180 film-coated tablets
60 alebo 180 filmom obalených tabliet.
Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
(%) účastníkov dosahujúcich remisiu podľa DAS28-4(FW) <
d. Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE
Pacientom, ktorí dosiahli klinickú odpoveď v 1 zo štúdie s indukčnou liečbou (OCTAVE Induction 1
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
EU/1/17/1178/005 60 filmom obalených tabliet EU/1/17/1178/006 180 filmom obalených tabliet
c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
c Celkovo dosiahnutá štatistická významnosť pri p ≤
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.
Pretrvávanie klinickej odpovede bolo definované ako pokles východiskového Mayo skóre o ≥ 3 body a ≥
PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING
PRE VNÚTORNÝ OBAL FĽAŠE PRE 10 MG
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,
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).
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).
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).
Tofacitinib Twice Daily + MTX
Tofacitinib dvakrát denne + MTX
Package leaflet: Information for the patient XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets tofacitinib
XELJANZ 5 mg filmom obalené tablety XELJANZ 10 mg filmom obalené tablety tofacitinib
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
Tabuľka 15: Podiel pacientov, ktorí dosiahli ukazovatele účinnosti v 8. týždni (štúdie OCTAVE
1 year
2 roky
What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
XELJANZ 5 mg filmom obalená tableta je biela a okrúhla.
• 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.
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.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
EU/1/17/1178/001 60 filmom obalených tabliet EU/1/17/1178/002 180 filmom obalených tabliet
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.
U pacientov dostávajúcich tofacitinib 5 alebo 10 mg dvakrát denne sa v skúšaniach ORAL Sync, ORAL Standard a ORAL
What XELJANZ contains
Obsah balenia a ďalšie informácie Čo XELJANZ obsahuje
Patients randomised to adalimumab (active-control arm) received 40 mg subcutaneously every 2 weeks for 12 months.
dostávali 40 mg subkutánne každé 2 týždne počas 12 mesiacov.
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Neodporúča sa začať liečbu tofacitinibom u pacientov s ANC nižším ako
Rheumatoid arthritis • The recommended dose is 5 mg twice a day.
Odporúčaná dávka je 5 mg dvakrát denne.
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.
Dávkovanie sa musí znížiť na 5 mg dvakrát denne, keď je pri normálnej funkcii pečene indikované dávkovanie
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.
Dávkovanie sa musí znížiť na 5 mg jedenkrát denne, keď je pri normálnej funkcii obličiek indikované dávkovanie
Hepatic impairment
Stearát horečnatý
Tofacitinib 10 mg Twice Daily Monotherapy N=394
Tofacitinib 10 mg dvakrát denne ako monoterapia N =
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
ŠKATUĽA NA 5 MG BLISTROVÉ BALENIE
Tofacitinib 5 mg Twice Daily Monotherapy N=370
Tofacitinib 5 mg dvakrát denne ako monoterapia N =
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Každá tableta obsahuje 10 mg tofacitinibu (ako tofacitinib citrát).
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.
liečení tofacitinibom 5 mg dvakrát denne mali významne vyššie miery odpovede ACR20 v porovnaní s placebom v 3. mesiaci.