FrancophonIA/ELRC3.0 huggingface dataset:
English: Olumiant has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Olumiant nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant.
Slovenian: V skladu s kliničnimi smernicami je treba pred začetkom zdravljenja z zdravilom Olumiant opraviti presejalni pregled za virusni hepatitis.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
English: Venous Thromboembolism
Slovenian: Venska trombembolija
English: Light pink, 9.0 x 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other.
Slovenian: Svetlo rožnate, podolgovate tablete velikosti 9,0 x 7,5 mm, z vtisnjenim napisom »Lilly« na eni strani in »2« na drugi strani.
English: 5 Most common concomitant cDMARDs included MTX, hydroxychloroquine, leflunomide and sulfasalazine
Slovenian: MTX, hidroksiklorokin, leflunomid in sulfasalazin.
English: Patients should not be immunised using live attenuated vaccines shortly before or during treatment with Olumiant.
Slovenian: Bolnikov se neposredno pred zdravljenjem z zdravilom Olumiant ali med njim ne sme imunizirati z uporabo živih oslabljenih cepiv.
English: In clinical pharmacology studies, coadministration of baricitinib with ketoconazole (strong CYP3A inhibitor) resulted in no clinically meaningful effect on the PK of baricitinib.
Slovenian: V študijah klinične farmakologije sočasno dajanje baricitiniba s ketokonazolom (močnim zaviralcem CYP3A) ni povzročilo klinično pomembnega učinka na farmakokinetiko baricitiniba.
English: Week 24 0.47 0.33 0.26*
Slovenian: 24. teden 0,47 0,33 0,26* 52. teden 0,81 0,55 0,34**
English: tacrolimus or ciclosporin - other medicines belonging to the group of Janus kinase inhibitors, such as ruxolitinib
Slovenian: - druga zdravila, ki spadajo v skupino zaviralcev Janus kinaze, kot je npr. ruksolitinib.
English: Week 52 1.02 0.80 0.40**
Slovenian: 24. teden 0,61 0,39 0,29* 52. teden 1,02 0,80 0,40**
English: Olumiant 4 mg film-coated tablets are medium pink, round tablets, with “Lilly” on one side and “4” on the other.
Slovenian: Olumiant 4 mg filmsko obložene tablete so srednje rožnate, okrogle tablete, z vtisnjenim napisom »Lilly« na eni strani in »4« na drugi strani.
English: Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other.
Slovenian: Srednje rožnate, okrogle tablete velikosti 8,5 mm, z vtisnjenim napisom »Lilly« na eni strani in »4« na drugi strani.
English: • cellulose, microcrystalline
Slovenian: • mikrokristalna celuloza
English: Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z baricitinibom, so v primerjavi s placebom poročali o zvišanju parametrov krvnih lipidov, odvisnem od odmerka zdravila (glejte poglavje 4.8).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
English: Olumiant 4 mg film-coated tablets Each film-coated tablet contains 4 mg baricitinib.
Slovenian: Olumiant 4 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 4 mg baricitiniba.
English: 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).
Slovenian: zdravljenih z zdravilom Olumiant 4 mg, dosegel remisijo, kot jo definira SDAI ≤ 3,3 in CDAI ≤ 2,8 (Preglednica 4).
English: 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.
Slovenian: Zvišanja CPK so opazili v 4. tednu in so ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
English: Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib.
Slovenian: Olumiant 2 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2 mg baricitiniba.
English: Pulmonary embolism
Slovenian: (pljučna embolija).
English: Baricitinib treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol.
Slovenian: vključno s skupnim holesterolom, trigliceridi, LDL-holesterolom in HDL-holesterolom.
English: No clinical pharmacology study has been conducted with OAT3 inhibitors with less inhibition potential.
Slovenian: OAT3 z manjšim potencialom za zaviranje niso opravili nobene študije klinične farmakologije.
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib.
Slovenian: Pri bolnikih, ki so prejemali baricitinib, so poročali o dogodkih globoke venske tromboze (GVT) in pljučne embolije (PE).
English: Anti-TB therapy should be considered prior to initiation of Olumiant in patients with previously untreated latent TB.
Slovenian: Pri bolnikih s predhodno nezdravljeno latentno TB je treba pred uvedbo zdravila Olumiant razmisliti o protituberkuloznem zdravljenju.
English: Patients should be screened for tuberculosis (TB) before starting Olumiant therapy.
Slovenian: Pred začetkom zdravljenja z zdravilom Olumiant je treba pri bolnikih opraviti presejalni test za tuberkulozo (TB).
English: • Primary endpoint: ACR20 at week 12
Slovenian: • Primarni opazovani dogodek:ACR20 v 12.
English: Deep Vein Thrombosis
Slovenian: Žilne bolezni globoka venska tromboza
English: 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.
Slovenian: 3,8 µmol/l v primerjavi s placebom; ravni so v nadaljevanju ostale stabilne vse do 104. tedna zdravljenja.
English: 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
Slovenian: 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.
English: What you need to know before you take Olumiant
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Olumiant Ne jemljite zdravila Olumiant:
English: 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).
Slovenian: 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).
English: - If you get any side effects, talk to your doctor, or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets
Slovenian: Olumiant 2 mg filmsko obložene tablete Olumiant 4 mg filmsko obložene tablete
English: The mean effects of intrinsic factors on PK parameters (AUC and Cmax) were generally within the inter-subject PK variability of baricitinib.
Slovenian: (AUC in Cmax) so bili na splošno v okviru variabilnosti farmakokinetike baricitiniba pri posameznem preiskovancu.
English: 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.
Slovenian: (ANC) < 1 x 109 celic/l, absolutnem številu limfocitov (ALC) < 0,5 x 109 celic/l in vrednosti hemoglobina < 8 g/dl.
English: Hypercholesterolaemiac
Slovenian: Presnovne in prehranske motnje hiperholesterolemijac hipertrigliceridemijac
English: Respiratory, thoracic, mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pljučna embolija
English: Thrombocytosis >600 x 109 cells/Lc
Slovenian: Bolezni krvi in limfatičnega sistema trombocitoza > 600 x 109 celic/lc nevtropenija < 1 x 109 celic/lc
English: NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg tablets baricitinib
Slovenian: IME ZDRAVILA Olumiant 2 mg tablete baricitinib
English: 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.
Slovenian: (ALT) in aspartat-aminotransferaze (AST) na ≥ 5-kratnik in ≥ 10-kratnik zgornje meje normalnih vrednosti (ULN).
English: • Primary endpoint: ACR20 at week 24
Slovenian: • Primarni opazovani dogodek: ACR20 v 24.
English: 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.
Slovenian: 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,
English: Hepatic transaminases
Slovenian: Zvišanje jetrnih transaminaz
English: NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg tablets baricitinib
Slovenian: IME ZDRAVILA Olumiant 4 mg tablete baricitinib
English: Baricitinib is not an inhibitor of the transporters OAT1, OAT2, OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.
Slovenian: Baricitinib ni zaviralec prenašalcev OAT1, OAT2, OAT3, OCT2, OATP1B1,
English: On background cDMARDs5 if on stable cDMARD at study entry
Slovenian: Bolniki, ki so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila5, če so bili stabilni na imunomodulirajoča protirevmatična zdravila ob vstopu v študijo
English: 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.
Slovenian: 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
English: 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).
Slovenian: 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.
English: It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.
Slovenian: Janus kinaze, ki pomagajo zmanjšati vnetje.
English: 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 %***
Slovenian: 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 %***
English: 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.
Slovenian: 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.
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster, herpes simplex), were reported in clinical studies (see section 4.8).
Slovenian: (npr. herpes zoster, herpes simpleks) (glejte poglavje 4.8).
English: 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.
Slovenian: Vzorec in incidenca zvišanja števila krvnih ploščic sta ostala v nadaljevanju stabilna, z višjo vrednostjo od izhodiščne, vključno z dolgoročno podaljšano študijo.
English: 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 %***
Slovenian: 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 %***
English: What Olumiant contains - The active substance is baricitinib.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Olumiant - Učinkovina je baricitinib.
English: 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.
Slovenian: 600 x 109 celic/l prišlo pri 2,0 % bolnikov, zdravljenih z zdravilom Olumiant 4 mg, in pri 1,1 %
English: Inhibition of IL-6 induced STAT3 phosphorylation
Slovenian: Bolniki, ki so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila5
English: Olumiant 4 mg film-coated tablets
Slovenian: Olumiant 4 mg filmsko obložene tablete
English: Swelling of the face, Urticaria
Slovenian: - akne - pridobivanje telesne mase - otekanje obraza, - urtikarija,
English: 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 %***
Slovenian: 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 %***
English: Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %**
Slovenian: 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.
English: • talc
Slovenian: • smukec
English: 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.
Slovenian: Olumiant 2 mg filmsko obložene tablete so svetlo rožnate, podolgovate tablete, z vtisnjenim napisom »Lilly« na eni strani in »2« na drugi strani.
English: Haematological abnormalities
Slovenian: Hematološke anomalije
English: Olumiant 2 mg film-coated tablets
Slovenian: Olumiant 2 mg filmsko obložene tablete
English: 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 %***
Slovenian: 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 %***
English: 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 %***
Slovenian: 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 %***
English: 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 %***
Slovenian: 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 %***
English: 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 %**
Slovenian: 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 %**
English: No adverse foetal effects were observed at exposures 2 times the human exposure based on AUC.
Slovenian: ustrezajo 2-kratni izpostavljenosti pri človeku, niso opazili neželenih učinkov na zarodek.
English: RA-BEGIN MTX-naïve patients
Slovenian: RA-BEGIN Bolniki, ki še niso bili zdravljeni z MTX
English: Taking into account the PRAC Assessment Report on the PSUR(s) for baricitinib, the scientific conclusions of CHMP are as follows:
Slovenian: 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 %
English: Joint Space Narrowing Score, mean change from baseline:
Slovenian: Ocena zožitve sklepne špranje, povprečna sprememba od izhodišča:
English: Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Week 52 16 % 25 %* 28 %**
Slovenian: 12. teden 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % 24. teden 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* 52. teden 16 % 25 %* 28 %**
English: There was no clinically relevant effect on the PK of baricitinib in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter niso opazili klinično pomembnega učinka na farmakokinetiko baricitiniba.
English: Olumiant contains the active substance baricitinib.
Slovenian: Zdravilo Olumiant vsebuje učinkovino baricitinib.
English: Hepatic Impairment
Slovenian: Maligne bolezni
English: Physical function response and health-related outcomes Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in physical function compared to all comparators (placebo, MTX, adalimumab), as measured by HAQ-DI, at 12, 24 and 52 weeks.
Slovenian: * p ≤ 0,05; ** p ≤ 0,01; *** p ≤ 0,001 v primerjavi s placebom (v primerjavi z MTX za študijo RA-BEGIN) Odzivi, povezani s telesno zmogljivostjo in izidi, povezani z zdravjem Zdravljenje z zdravilom Olumiant 4 mg samim ali v kombinaciji s konvencionalnimi imunomodulirajočimi protirevmatičnimi zdravili je povzročilo bistveno izboljšanje telesne zmogljivosti v primerjavi z vsemi primerjalnimi zdravili (placebo, MTX, adalimumab), kot so ocenili s pomočjo vprašalnika HAQ-DI, v 12., 24. in 52. tednu.
English: Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tuberculosis - have had a herpes infection (shingles), because Olumiant may allow it to come back.
Slovenian: Obvestite svojega zdravnika, če se med zdravljenjem z zdravilom Olumiant pri vas pojavi boleč kožni izpuščaj z mehurji, saj so to lahko znaki pasavca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 4 MG FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 4 MG FILMSKO OBLOŽENE TABLETE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 2 MG FILM-COATED TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLE ZA 2 MG FILMSKO OBLOŽENE TABLETE
English: Lymphocytes
Slovenian: Trombocitoza
English: Fri.
Slovenian: Sob.
English: Very common side effects (may affect more than 1 in 10 people): - throat and nose infections - high levels of blood fat (cholesterol) shown by blood test
Slovenian: - visoke ravni krvnih maščob (holesterola), ki jih pokaže krvna preiskava Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: How to take Olumiant
Slovenian: Če ste prenehali jemati zdravilo Olumiant
English: Acne
Slovenian: Navzea
English: • Use effective contraception while taking Olumiant (and for 1 week after, if you stop treatment).
Slovenian: • Med jemanjem zdravila Olumiant uporabljajte učinkovito kontracepcijo
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 4 MG FILM-COATED TABLETS
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI ZA 4 MG FILMSKO OBLOŽENE TABLETE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 2 MG FILM-COATED TABLETS
Slovenian: PERFORIRANI ENOODMERNI PRETISNI OMOTI ZA 2 MG FILMSKO OBLOŽENE TABLETE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 4 MG FILM-COATED TABLETS
Slovenian: PERFORIRANI ENOODMERNI PRETISNI OMOTI ZA 4 MG FILMSKO OBLOŽENE TABLETE
English: Uncommon side effects (may affect up to 1 in 100 people): - low number of white bloods cells (neutrophils), shown by blood test - increase in an enzyme called creatine kinase, shown by blood test - high levels of blood fat (triglycerides), shown by blood test - acne - weight gain - swelling of the face - urticaria - blood clots in the blood vessels of the lungs - blood clot in the veins of the legs or pelvis, called a deep vein thrombosis (DVT)
Slovenian: - povečanje ravni encima, imenovanega kreatin-kinaza, ki ga pokaže krvna preiskava - visoke ravni krvnih maščob (trigliceridov), ki jih pokaže krvna preiskava
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 2 MG FILM-COATED TABLETS
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI ZA 2 MG FILMSKO OBLOŽENE TABLETE
English: ‘Idiopathic' means that the cause of the disease is unknown.
Slovenian: „Idiopatska“ pomeni, da vzrok bolezni ni znan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ofev, veljavno po vsej Evropski uniji, izdala 15. januarja 2015.
English: What measures are being taken to ensure the safe and effective use of Ofev?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ofev?
English: Ofev is available as capsules (100 and 150 mg).
Slovenian: Zdravilo Ofev je na voljo v obliki kapsul (100 in 150 mg).
English: Other information about Ofev
Slovenian: Druge informacije o zdravilu Ofev
English: The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml).
Slovenian: Povprečna FVC bolnikov pred zdravljenjem je znašala od 2600 do 2700 mililitrov (ml).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ofev's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ofev večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.