natgillin/translations-raw huggingface dataset:
Decreases in lymphocytes, eosinophils and basophils as well as lymphoid depletion in organs/tissues of the immune system were observed in mice, rats and dogs.
Pri miših, podganah in psih so opazili znižanje števila limfocitov, eozinofilcev in bazofilcev ter izginjanje limfatičnih centrov v organih/tkivih imunskega sistema.
In treatment-naïve patients, for up to 52 weeks, the frequency of upper respiratory tract infections was greater for the combination treatment of methotrexate and Olumiant (26.0 %) compared to methotrexate alone (22.9 %) or Olumiant alone (22.0 %).
Pri bolnikih, ki predhodno niso bili zdravljeni, je bila v obdobju do 52 tednov pogostnost okužbe zgornjih dihalnih poti večja pri kombiniranem zdravljenju z metotreksatom in zdravilom Olumiant (26,0 %) v primerjavi s samim metotreksatom (22,9 %) ali samim zdravilom Olumiant (22,0 %).
Gastric pH modifying agents Elevating gastric pH with omeprazole had no clinically significant effect on baricitinib exposure.
Dvig pH vrednosti v želodcu z omeprazolom ni imel klinično pomembnega učinka na izpostavljenost baricitinibu.
EU/1/16/1170/009 (14 film-coated tablets) EU/1/16/1170/010 (28 film-coated tablets) EU/1/16/1170/011 (28 x 1 film-coated tablets) EU/1/16/1170/012 (35 film-coated tablets) EU/1/16/1170/013 (56 film-coated tablets) EU/1/16/1170/014 (84 film-coated tablets) EU/1/16/1170/015 (84 x 1 film-coated tablets) EU/1/16/1170/016 (98 film-coated tablets)
EU/1/16/1170/009 (14 filmsko obloženih tablet) EU/1/16/1170/010 (28 filmsko obloženih tablet) EU/1/16/1170/011 (28 x 1 filmsko obložena tableta) EU/1/16/1170/012 (35 filmsko obloženih tablet) EU/1/16/1170/013 (56 filmsko obloženih tablet) EU/1/16/1170/014 (84 filmsko obloženih tablet) EU/1/16/1170/015 (84 x 1 filmsko obložena tableta) EU/1/16/1170/016 (98 filmsko obloženih tablet)
Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in pain compared to all comparators (placebo, MTX, adalimumab), as measured on a 0-100 visual analogue scale, at 12 weeks.
Zdravljenje z zdravilom Olumiant 4 mg samim ali v kombinaciji s konvencionalnimi imunomodulirajočimi protirevmatičnimi zdravili je povzročilo bistveno izboljšanje nadzora bolečine v primerjavi z vsemi primerjalnimi zdravili (placebo, MTX, adalimumab), kot so ocenili s pomočjo vizualne analogne lestvice 0-100 v 12. tednu.
• Increased total cholesterol ≥ 5.17 mmol/L: 49.1 % vs.15.8 %, respectively
• zvišan skupni holesterol ≥ 5,17 mmol/l: 49,1 % v primerjavi s 15,8 %
In a clinical pharmacology study, baricitinib was excreted predominately as the unchanged active substance in urine (69 %) and faeces (15 %) and only 4 minor oxidative metabolites were identified (3 in urine; 1 in faeces) constituting approximately 5 % and 1 % of the dose, respectively.
(69 %) in blatu (15 %), prepoznali so le 4 manjše oksidativne presnovke (3 v urinu; 1 v blatu) kar skupno predstavlja približno 5 % in 1 % odmerka.
• Increased HDL cholesterol ≥ 1.55 mmol/L: 42.7 % vs. 13.8 %, respectively
• zvišan HDL-holesterol ≥ 1,55 mmol/l: 42,7 % v primerjavi z 13,8 %
• At week 24: 163/191 (85 %) continuing 4 mg vs. 144/189 (76 %) reduced to 2 mg (p ≤ 0.05)
• V 24. tednu: 163/191 (85 %) bolnikov, ki so nadaljevali z jemanjem odmerka 4 mg, v primerjavi s 144/189 (76 %) bolnikov, ki so jemali zmanjšan odmerek 2 mg (p ≤ 0,05).
In controlled studies, for up to 16 weeks, decreases in neutrophil counts below 1 x 109 cells/L occurred in 0.3 % of patients treated with Olumiant compared to 0 % of patients treated with placebo.
V nadzorovanih študijah je v obdobju do 16 tednov do znižanja števila nevtrofilcev pod 1 x 109 celic/l prišlo pri 0,3 % bolnikov, zdravljenih z zdravilom Olumiant v primerjavi z 0 % bolnikov, ki so prejemali placebo.
In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported.
Iz obdobja trženja so v povezavi z uporabo baricitiniba poročali o primerih preobčutljivosti na zdravilo.
Elevations were observed at 12 weeks and remained stable thereafter at a higher value than baseline including in the long-term extension study.
Zvišanja so opazili v 12. tednu in so ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
Olumiant is for oral use.
Zdravilo Olumiant je namenjeno za peroralno uporabo.
Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of shingles (herpes zoster): - painful skin rash with blisters and fever
Če opazite katerega od spodaj naštetih simptomov, morate takoj obvestiti svojega zdravnika ali poiskati zdravniško pomoč, saj lahko gre za znake pasavca (herpes zoster): - boleč kožni izpuščaj z mehurji in zvišano telesno temperaturo
Erosion Score, Mean change from baseline:
Ocena erozije, povprečna sprememba od izhodišča:
In treatment-naïve patients, through 52 weeks, the frequency of nausea was greater for the combination treatment of methotrexate and Olumiant (9.3 %) compared to methotrexate alone (6.2 %) or Olumiant alone (4.4 %).
Pri bolnikih, ki predhodno niso bili zdravljeni, je bila v obdobju 52 tednov pogostnost navzee večja pri kombiniranem zdravljenju z metotreksatom in zdravilom Olumiant (9,3 %) v primerjavi s samim metotreksatom (6,2 %) ali samim zdravilom Olumiant (4,4 %).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
You may need tests to check for tuberculosis before you are given Olumiant.
Preden boste prejeli zdravilo Olumiant, boste morda morali opraviti preiskave na tuberkulozo.
The pattern and incidence of decreases in neutrophil counts remained stable at a lower value than baseline over time including in the long-term extension study.
Vzorec in incidenca znižanja števila nevtrofilcev sta ostala v nadaljevanju stabilna, z nižjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
ALT increased ≥3 x ULNc AST increased ≥3 x ULNc
≥3 x ULNc
Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in significant improvements in all individual ACR components, including tender and swollen joint counts, patient and physician global assessments, HAQ-DI, pain assessment and CRP, compared to placebo or MTX monotherapy.
Zdravljenje z zdravilom Olumiant 4 mg samim ali v kombinaciji s konvencionalnimi imunomodulirajočimi protirevmatičnimi zdravili je v primerjavi s placebom ali monoterapijo z MTX povzročilo pomembna izboljšanja vseh posamičnih komponent ACR, vključno s številom bolečih in oteklih sklepov, globalnimi ocenami z vidika bolnika in zdravnika, HAQ-DI, oceno bolečine in CRP.
Hepatic transaminase elevations
Zvišanja jetrnih transaminaz
If you stop taking Olumiant Do not stop taking Olumiant unless your doctor tells you to stop taking it.
Ne prenehajte jemati zdravila Olumiant, če vam tega ni naročil zdravnik.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj akne
Data from clinical studies shows that the incidence rate of urticaria and face oedema is higher in the baricitinib 4 mg arm [urticarial: 0.60; face oedema: 0.89] compared to placebo arm [urticarial: 0.29; face oedema:0.29].
Podatki iz kliničnih študij kažejo, da je pojavnost urtikarije in edema obraza večja v skupini, ki je prejemala baricitinib 4 mg [urtikarija: 0,60; edem obraza: 0,89], kot v skupini, ki je prejemala placebo
Olumiant has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Olumiant nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant.
V skladu s kliničnimi smernicami je treba pred začetkom zdravljenja z zdravilom Olumiant opraviti presejalni pregled za virusni hepatitis.
MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
Venous Thromboembolism
Venska trombembolija
Light pink, 9.0 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other.
Svetlo rožnate, podolgovate tablete velikosti 9,0 x 7,5 mm, z vtisnjenim napisom »Lilly« na eni strani in »2« na drugi strani.
5 Most common concomitant cDMARDs included MTX, hydroxychloroquine, leflunomide and sulfasalazine
MTX, hidroksiklorokin, leflunomid in sulfasalazin.
Patients should not be immunised using live attenuated vaccines shortly before or during treatment with Olumiant.
Bolnikov se neposredno pred zdravljenjem z zdravilom Olumiant ali med njim ne sme imunizirati z uporabo živih oslabljenih cepiv.
In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.
V študijah klinične farmakologije sočasno dajanje baricitiniba s ketokonazolom (močnim zaviralcem CYP3A) ni povzročilo klinično pomembnega učinka na farmakokinetiko baricitiniba.
Week 24 0.47 0.33 0.26*
24. teden 0,47 0,33 0,26* 52. teden 0,81 0,55 0,34**
tacrolimus or ciclosporin - other medicines belonging to the group of Janus kinase inhibitors, such as ruxolitinib
- druga zdravila, ki spadajo v skupino zaviralcev Janus kinaze, kot je npr. ruksolitinib.
Week 52 1.02 0.80 0.40**
24. teden 0,61 0,39 0,29* 52. teden 1,02 0,80 0,40**
Olumiant 4 mg film-coated tablets are medium pink, round tablets, with “Lilly” on one side and “4” on the other.
Olumiant 4 mg filmsko obložene tablete so srednje rožnate, okrogle tablete, z vtisnjenim napisom »Lilly« na eni strani in »4« na drugi strani.
Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other.
Srednje rožnate, okrogle tablete velikosti 8,5 mm, z vtisnjenim napisom »Lilly« na eni strani in »4« na drugi strani.
• cellulose, microcrystalline
• mikrokristalna celuloza
Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo (see section 4.8).
Pri bolnikih, zdravljenih z baricitinibom, so v primerjavi s placebom poročali o zvišanju parametrov krvnih lipidov, odvisnem od odmerka zdravila (glejte poglavje 4.8).
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
Olumiant 4 mg film-coated tablets Each film-coated tablet contains 4 mg baricitinib.
Olumiant 4 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 4 mg baricitiniba.
A statistically significantly greater proportion of patients treated with Olumiant 4 mg compared to placebo or MTX achieved remission, as defined by SDAI ≤ 3.3 and CDAI ≤ 2.8, at weeks 12 and 24 (Table 4).
zdravljenih z zdravilom Olumiant 4 mg, dosegel remisijo, kot jo definira SDAI ≤ 3,3 in CDAI ≤ 2,8 (Preglednica 4).
Elevations of CPK were observed at 4 weeks and remained stable at a higher value than baseline thereafter including in the long-term extension study.
Zvišanja CPK so opazili v 4. tednu in so ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib.
Olumiant 2 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2 mg baricitiniba.
Pulmonary embolism
(pljučna embolija).
Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
vključno s skupnim holesterolom, trigliceridi, LDL-holesterolom in HDL-holesterolom.
No clinical pharmacology study has been conducted with OAT3 inhibitors with less inhibition potential.
OAT3 z manjšim potencialom za zaviranje niso opravili nobene študije klinične farmakologije.
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.
Pri bolnikih, ki so prejemali baricitinib, so poročali o dogodkih globoke venske tromboze (GVT) in pljučne embolije (PE).
Anti-TB therapy should be considered prior to initiation of Olumiant in patients with previously untreated latent TB.
Pri bolnikih s predhodno nezdravljeno latentno TB je treba pred uvedbo zdravila Olumiant razmisliti o protituberkuloznem zdravljenju.
Patients should be screened for tuberculosis (TB) before starting Olumiant therapy.
Pred začetkom zdravljenja z zdravilom Olumiant je treba pri bolnikih opraviti presejalni test za tuberkulozo (TB).
• Primary endpoint: ACR20 at week 12
• Primarni opazovani dogodek:ACR20 v 12.
Deep Vein Thrombosis
Žilne bolezni globoka venska tromboza
Baricitinib induced a mean increase in serum creatinine levels of 3.8 µmol/L after two weeks of treatment, as compared to placebo, which remained stable thereafter during up to 104 weeks of treatment.
3,8 µmol/l v primerjavi s placebom; ravni so v nadaljevanju ostale stabilne vse do 104. tedna zdravljenja.
2 Patients who had an inadequate response to MTX (+/- other cDMARDs); biologic-naïve 3 Patients who had an inadequate response or were intolerant to ≥ 1 cDMARDs; biologic- naïve 4 Patients who had an inadequate response or were intolerant to ≥ 1 bDMARDs; including at least one TNF inhibitor
4 Bolniki, ki niso imeli zadostnega odziva na vsaj eno biološko imunomodulirajoče protirevmatično zdravilo ali pa ga niso prenašali; vključno z najmanj enim zaviralcem TNF.
What you need to know before you take Olumiant
Kaj morate vedeti, preden boste vzeli zdravilo Olumiant Ne jemljite zdravila Olumiant:
The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see section 4.5).
Priporočeni odmerek pri bolnikih, ki jemljejo zaviralce prenašalca organskih anionov (OAT3) z močnim potencialom za zaviranje, kot je npr. probenecid, je 2 mg enkrat na dan (glejte poglavje 4.5).
- If you get any side effects, talk to your doctor, or pharmacist or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets
Olumiant 2 mg filmsko obložene tablete Olumiant 4 mg filmsko obložene tablete
The mean effects of intrinsic factors on PK parameters (AUC and Cmax) were generally within the inter-subject PK variability of baricitinib.
(AUC in Cmax) so bili na splošno v okviru variabilnosti farmakokinetike baricitiniba pri posameznem preiskovancu.
Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in less than 1 % of patients in clinical trials.
(ANC) < 1 x 109 celic/l, absolutnem številu limfocitov (ALC) < 0,5 x 109 celic/l in vrednosti hemoglobina < 8 g/dl.
Hypercholesterolaemiac
Presnovne in prehranske motnje hiperholesterolemijac hipertrigliceridemijac
Respiratory, thoracic, mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora pljučna embolija
Thrombocytosis >600 x 109 cells/Lc
Bolezni krvi in limfatičnega sistema trombocitoza > 600 x 109 celic/lc nevtropenija < 1 x 109 celic/lc
NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg tablets baricitinib
IME ZDRAVILA Olumiant 2 mg tablete baricitinib
Increases in alanine transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10 x upper limit of normal (ULN) were reported in less than 1 % of patients in clinical trials.
(ALT) in aspartat-aminotransferaze (AST) na ≥ 5-kratnik in ≥ 10-kratnik zgornje meje normalnih vrednosti (ULN).
• Primary endpoint: ACR20 at week 24
• Primarni opazovani dogodek: ACR20 v 24.
In studies which included both doses, infections were reported in 31.9%, 28.8% and 24.1% of patients up to 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
V študijah, ki so vključevale oba odmerka, so o okužbah v obdobju do 16 tednov poročali pri 31,9 % bolnikov v skupini s 4 mg,
Hepatic transaminases
Zvišanje jetrnih transaminaz
NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg tablets baricitinib
IME ZDRAVILA Olumiant 4 mg tablete baricitinib
Baricitinib is not an inhibitor of the transporters OAT1, OAT2, OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.
Baricitinib ni zaviralec prenašalcev OAT1, OAT2, OAT3, OCT2, OATP1B1,
On background cDMARDs5 if on stable cDMARD at study entry
Bolniki, ki so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila5, če so bili stabilni na imunomodulirajoča protirevmatična zdravila ob vstopu v študijo
Differences in efficacy between the 4 mg and the 2 mg doses were most notable in the bDMARD-IR population (RA-BEACON), in which statistically significant improvements in the ACR components of swollen joint count, tender joint count and ESR were shown for Olumiant 4 mg compared to placebo at Week 24 but not for Olumiant 2 mg compared to placebo.
Razlike v učinkovitosti med odmerkoma 4 mg in 2 mg so bile najbolj očitne v populaciji bDMARD-IR (študija RA-BEACON), v kateri so opazili statistično značilna izboljšanja komponent
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Pri bolnikih, pri katerih med redno obravnavo bolnika opazimo vrednosti ANC < 1 x 109 celic/l, ALC < 0,5 x 109 celic/l ali hemoglobin < 8 g/dl, zdravljenja ne smemo uvesti oziroma ga moramo začasno prekiniti.
It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.
Janus kinaze, ki pomagajo zmanjšati vnetje.
Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Week 52 13 % 25 %** 30 %***
12. teden 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % 24. teden 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** 52. teden 13 % 25 %** 30 %***
A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
od običajnih so v obdobju do 16 tednov poročali pri 1,5 % bolnikov v skupini s 4 mg, 0,8 % bolnikov v skupini z 2 mg in pri 0,6 % bolnikov v skupini s placebom.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see section 4.8).
(npr. herpes zoster, herpes simpleks) (glejte poglavje 4.8).
The pattern and incidence of increases in platelet counts remained stable at a higher value than baseline over time including in the long term extension study.
Vzorec in incidenca zvišanja števila krvnih ploščic sta ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Week 52 56 % 73 %*** 73 %***
12. teden 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** 24. teden 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** 52. teden 56 % 73 %*** 73 %***
What Olumiant contains - The active substance is baricitinib.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Olumiant - Učinkovina je baricitinib.
In controlled studies, for up to 16 weeks, increases in platelet counts above 600 x 109 cells/L occurred in 2.0 % of patients treated with Olumiant 4 mg and 1.1 % of patients treated with placebo.
600 x 109 celic/l prišlo pri 2,0 % bolnikov, zdravljenih z zdravilom Olumiant 4 mg, in pri 1,1 %
Inhibition of IL-6 induced STAT3 phosphorylation
Bolniki, ki so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila5
Olumiant 4 mg film-coated tablets
Olumiant 4 mg filmsko obložene tablete
Swelling of the face, Urticaria
- akne - pridobivanje telesne mase - otekanje obraza, - urtikarija,
Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Week 52 38 % 57 %*** 63 %***
12. teden 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** 24. teden 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** 52. teden 38 % 57 %*** 63 %***
Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %**
24. teden 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % 52. teden 66 % 69 % 80 %** 70 % 79 %** 81 %** Razlaga kratic: ADA = adalimumab; MTX = metotreksat; OLU = Olumiant; PBO = placebo a Podatki za placebo so bili v 52. tednu izpeljani s pomočjo linearne ekstrapolacije.
• talc
• smukec
What Olumiant looks like and contents of the pack Olumiant 2 mg film-coated tablets are light pink, oblong tablets, with “Lilly” on one side and “2” on the other.
Olumiant 2 mg filmsko obložene tablete so svetlo rožnate, podolgovate tablete, z vtisnjenim napisom »Lilly« na eni strani in »2« na drugi strani.
Haematological abnormalities
Hematološke anomalije
Olumiant 2 mg film-coated tablets
Olumiant 2 mg filmsko obložene tablete
Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Week 52 27 % 36 % 45 %***
12. teden 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** 24. teden 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** 52. teden 27 % 36 % 45 %***
Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Week 52 38 % 57 %*** 62 %***
12. teden 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** 24. teden 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** 52. teden 38 % 57 %*** 62 %***
Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Week 52 25 % 42 %*** 46 %***
12. teden 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** 24. teden 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** 52. teden 25 % 42 %*** 46 %***
HAQ-DI Minimum Clinically Important Difference (decrease in HAQ-DI score of ≥ 0.30): Week 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Week 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Week 52 53 % 65 %* 67 %**
12. teden 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** 24. teden 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** 52. teden 53 % 65 %* 67 %**
No adverse foetal effects were observed at exposures 2 times the human exposure based on AUC.
ustrezajo 2-kratni izpostavljenosti pri človeku, niso opazili neželenih učinkov na zarodek.
RA-BEGIN MTX-naïve patients
RA-BEGIN Bolniki, ki še niso bili zdravljeni z MTX
Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za baricitinib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke: V s placebom nadzorovanih preskušanjih so opazili neravnovesje v številu poročil o VTE, in sicer 0 %