FrancophonIA/ELRC3.0 huggingface dataset:
English: • prolonged coagulation (clotting) test times
Slovenian: • podaljšan čas pri testu koagulacije (strjevanja krvi)
English: If your doctor has allowed you to self-inject and you forget to give yourself an injection, you should inject yourself as soon as you remember and contact your doctor for information.
Slovenian: Če vam je zdravnik dovolil, da si zdravilo injicirate sami in ste si ga pozabili injicirati, si naslednji odmerek vbrizgajte takoj, ko je to mogoče, in se posvetujte z zdravnikom.
English: One ml pre-filled pen (AutoClicks) containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Slovenian: En ml napolnjenega injekcijskega peresnika (AutoClicks) vsebuje napolnjeno injekcijsko brizgo (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko, ki vsebuje 200 mg certolizumab pegola.
English: In addition, uncommon cases of non-melanoma skin cancer have been observed in patients taking Cimzia.
Slovenian: Poleg tega so pri bolnikih, ki so jemali zdravilo Cimzia, občasno poročali o primerih nemelanomskega raka kože.
English: Comprehensive instructions for the preparation and administration of Cimzia in a dose-dispenser cartridge are given in the package leaflet and in the user manual provided with the electromechanical injection device ava.
Slovenian: Obsežna navodila za pripravo in uporabo zdravila Cimzia v obliki z odmernim vložkom so podana v navodilu za uporabo in priročniku za uporabo, ki je priložen k elektromehanski injekcijski napravi ava.
English: Injecting the solution subcutaneously which contains air bubbles is harmless.
Slovenian: Subkutano injiciranje raztopine, ki vsebuje mehurčke je neškodljivo.
English: Antibody formation was associated with lowered drug plasma concentration and in some patients, reduced efficacy.
Slovenian: Nastanek protiteles je bil povezan z znižano koncentracijo zdravila v plazmi, pri nekaterih bolnikih pa je imel za posledico zmanjšano učinkovitost.
English: If this occurs, you should stop using Cimzia.
Slovenian: Če se to zgodi, morate zdravljenje z zdravilom Cimzia nemudoma prekiniti.
English: The total content (1 ml) of the dose-dispenser cartridge should be administered using the electromechanical injection device ava for a subcutaneous injection only.
Slovenian: Celotno vsebino (1 ml) odmernega vložka je treba aplicirati z uporabo elektromehanske injekcijske naprave ava le v obliki subkutane injekcije.
English: Cimzia, which you will take in combination with methotrexate, is used to:
Slovenian: Zdravilo Cimzia v kombinaciji z metotreksatom se uporablja za:
English: Specific clinical trials have not been performed to assess the effect of hepatic impairment on the pharmacokinetics of certolizumab pegol.
Slovenian: Specifične klinične študije za oceno učinka motenj v delovanju jeter na farmakokinetiko certolizumab pegola niso bile izvedene.
English: Do not touch this area again before injection.
Slovenian: - Tega predela se ne dotikajte več, dokler si ne boste dali injekcije.
English: Patients who develop a new infection while undergoing treatment with Cimzia should be monitored closely.
Slovenian: Pozorno je treba spremljati bolnike, pri katerih se v času zdravljenja z zdravilom Cimzia razvije nova okužba.
English: - It is uncommon, but symptoms of a disease called lupus (for example persistent rash, fever, joint pain and tiredness) may occur.
Slovenian: - V redkih primerih se lahko razvijejo simptomi bolezni, ki se imenuje lupus (npr. dalj časa trajajoč izpuščaj, zvišana telesna temperatura, bolečina v sklepih in utrujenost).
English: If you are given too much Cimzia
Slovenian: Če ste prejeli večji odmerek zdravila Cimzia
English: • gastrointestinal cancer, melanoma
Slovenian: • rak prebavil, melanom
English: N/A: Not Applicable *Wald p-values for Cimzia 200 mg vs. placebo and Cimzia 400 mg vs. placebo comparisons are estimated from a logistic regression model with factors for treatment
Slovenian: *Waldove p-vrednosti za zdravilo Cimzia 200 mg v primerjavi s placebom in za zdravilo Cimzia 400 mg v primerjavi s placebom so ocenjene z logistično regresijo s faktorji za zdravljenje
English: For rheumatoid arthritis and psoriatic arthritis, MTX should be continued during treatment with Cimzia where appropriate.
Slovenian: Po potrebi bolnik z revmatoidnim artritisom in psoriatičnim artritisom med zdravljenjem z zdravilom Cimzia še naprej prejema MTX.
English: Use of anti-tuberculosis therapy should also be considered before the initiation of Cimzia in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis.
Slovenian: Pri bolnikih z latentno ali aktivno tuberkulozo v osebni anamnezi, pri katerih ni mogoče potrditi ustreznega režima zdravljenja, in pri bolnikih, kjer so dejavniki tveganja za tuberkulozo kljub negativnim rezultatom testiranja za latentno tuberkulozo precejšnji, je treba pred uvedbo zdravljenja z zdravilom Cimzia razmisliti tudi o možnosti zdravljenja tuberkuloze.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 6.8%.
Slovenian: Celotni delež bolnikov, ki so bili pozitivni za protitelesa z vztrajnim zmanjšanjem plazemske koncentracije učinkovine, je bil ocenjen na 6,8 %.
English: - You may cover the injection site with a small adhesive bandage, if necessary.
Slovenian: - Če je potrebno lahko mesto injiciranja pokrijete z majhnim samolepilnim obližem.
English: Of the 135 patients randomised to Cimzia 400 mg every 4 weeks, 89, 62 and 41 patients had an ACR 20/50/70 response, respectively.
Slovenian: Od 135 bolnikov, ki so randomizirano prejemali 400 mg zdravila Cimzia 4 tedne, je 89 bolnikov imelo odziv ACR 20, 62 odziv ACR 50 in 41 odziv ACR 70.
English: Sodium acetate Sodium chloride Water for injections
Slovenian: 6.1 Seznam pomožnih snovi natrijev acetat natrijev klorid voda za injekcije
English: • skin disorders such as new onset or worsening of psoriasis, inflammation of the skin (such as eczema), sweat gland disorders, ulcers, photosensitivity, acne, hair loss, discoloration, nail separation, dry skin and injuries
Slovenian: • kožna obolenja, kot so pojav ali poslabšanje luskavice, vnetje kože (kot je ekcem), motnje žlez znojnic, razjede, fotosenzitivnost, akne, izguba las, razbarvanost, odstopanje nohtov, suha koža in poškodbe
English: • enlarged spleen
Slovenian: • povečana vranica
English: There was no effect of gender on the pharmacokinetics of certolizumab pegol.
Slovenian: Učinka spola na farmakokinetiko certolizumab pegola niso opazili.
English: Table11: Clinical response in studies CIMPASI-1 and CIMPASI-2 at Week 16 and Week 48 Week 16
Slovenian: Preglednica 11: Klinični odziv v študijah CIMPASI-1 in CIMPASI-2 v 16. tednu in 48. tednu 16. teden
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zaviralci TNF, vključno s certolizumab pegolom, so poročali o melanomu in karcinomu Merklovih celic (glejte poglavje 4.8).
English: Excipients: sodium acetate, sodium chloride and water for injections.
Slovenian: SEZNAM POMOŽNIIH SNOVI Pomožne snovi so: natrijev acetat, natrijev klorid in voda za injekcije.
English: The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Slovenian: Najpogostejše vrste neželenih učinkov so bile infekcijske in parazitske bolezni, ki so se pojavile pri 14,4 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 8,0 % bolnikov, ki so prejemali placebo, splošne težave in spremembe na mestu aplikacije, ki so se pojavile pri 8,8 % bolnikov, ki so dobivali zdravilo Cimzia, in 7,4 % bolnikov, ki so prejemali placebo, ter bolezni kože in podkožja, ki so se pojavile pri 7,0 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 2,4 % bolnikov, ki so prejemali placebo.
English: Operations or dental procedures - Talk to your doctor if you are going to have any operations or dental procedures.
Slovenian: Operativni in zobozdravstveni posegi Če ste naročeni na operativni ali zobozdravstveni poseg, o tem obvestite svojega zdravnika.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8) as instructed by your physician.
Slovenian: • Sledi vzdrževalni odmerek 200 mg vsak drugi teden (po 6 tednih) ali 400 mg vsake 4 tedne (po 8
English: Excluding non-melanoma of the skin, 121 malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4,049 patients were treated, representing 9,277 patient-years.
Slovenian: Če ne upštevamo nemelanomskega raka kože, so v okviru kliničnih študij za zdravilo Cimzia za revmatoidni artritis, v katerem je sodelovalo 4.049 bolnikov, opazili 121 malignih obolenj, vključno s 5 primeri limfoma, kar predstavlja 9,277 bolnikovih let.
English: Uncommo menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
Slovenian: občasni motnje menstrualnega cikla in materničnih krvavitev (vključno z amenorejo), obolenja dojk
English: • skin sloughing, blistering, hair texture disorder
Slovenian: • luščenje kože, vročinski izpuščaji, motnje v strukturi las
English: Common pyrexia, pain (any site), asthaenia, pruritus (any site), injection site reactions
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti pireksija, bolečina (na različnih mestih), astenija, pruritus (na različnih mestih), reakcije na mestu injiciranja
English: Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis subpopulations)
Slovenian: Aksialni spondiloartritis (podskupine z neradiografskim aksialnim spondiloartritisom in ankilozirajočim spondilitisom)
English: Physical function response and health-related outcomes In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
Slovenian: Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V kliničnem preskušanju PsA001 so v primerjavi s placebom bolniki, ki so se zdravili z zdravilom Cimzia, poročali o značilnih izboljšanjih telesnih funkcij, ocenjeno z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (HAQ-DI - Health Assessment Questionnaire - Disability Index), značilnih izboljšanjih bolečine, ocenjeno sPAAP, in značilnih izboljšanjih glede utrujenosti, določeno z lestvico za ocenjevanje utrujenosti (FAS - Fatigue Assessment Scale).
English: (a) Cimzia all dosing regimen = data from Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 plus Cimzia 400 mg administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Results are from the randomized set (c) Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
Slovenian: (a) Cimzia vsi režimi odmerjanja = rezultati pri odmerjanju zdravila Cimzia 200 mg vsaka 2 tedna po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden ter rezultati pri odmerjanju zdravila Cimzia 400 mg vsake 4 tedne po prejemanju polnilnega odmerka na začetku zdravljenja, drugi in četrti teden (b) Rezultati iz naključnega vzorca (c) Waldove p-vrednosti so citirane za primerjavo zdravljenj.
English: In the placebo+MTX group, 49.7% of patients experienced no radiographic progression (change in mTSS ≤0.5) at Week 52 compared to 70.3% in the Cimzia+MTX group (p<0.001).
Slovenian: V skupini, ki je v 52. tednu prejemala placebo in MTX je bilo 49,7 % bolnikov brez radiografske progresije (spremembe v mTSS ≤ 0,5), v skupini, ki je prejemala zdravilo Cimzia in MTX, je bilo 70,3 % bolnikov brez radiografske progresije.
English: Specific clinical trials have not been performed to assess the effect of renal impairment on the pharmacokinetics of certolizumab pegol or its PEG fraction.
Slovenian: Za oceno učinka motenj v delovanju ledvic na farmakokinetiko certolizumab pegola ali njegove frakcije PEG niso bile izvedene specifične klinične študije.
English: Paediatric malignancy
Slovenian: Maligna obolenja pri pediatrični populaciji
English: Uncommo electrolyte imbalance, dyslipidaemia, appetite disorders, weight change
Slovenian: Bolezni endokrinega sistema redki motnje v delovanju ščitnice občasni neravnovesje elektrolitov, dislipidemija, motnje apetita, sprememba telesne mase
English: • symptoms of blood disorders such as persistent fever, bruising, bleeding, paleness
Slovenian: • simptomi krvnih bolezni, kot so dalj časa trajajoča zvišana telesna temperatura, modrice,
English: Medication information chip 5.
Slovenian: b) Lestvica kategorije PGA 5.
English: • Push the plunger to inject solution.
Slovenian: • S potiskanjem bata vbrizgajte raztopino.
English: • Look at the expiry date on the medication and pack.
Slovenian: • Preverite rok uporabnosti na zdravilu in na pakiranju.
English: Please read the instructions at the end of this leaflet on how to inject Cimzia and in the user manual provided with the injection device ava.
Slovenian: Preberite navodila glede injiciranja zdravila Cimzia, ki so na koncu navodila za uporabo in v priročniku, ki je priložen k injekcijski napravi ava.
English: After Use • Do not re-use the cartridge
Slovenian: Po uporabi • Vložka ne uporabite ponovno.
English: Cimzia is used to treat moderate to severe plaque psoriasis.
Slovenian: Zdravilo Cimzia se uporablja za zdravljenje zmerne do hude psoriaze v plakih.
English: • Allow the pre-filled syringe to reach room temperature.
Slovenian: • Pred injiciranjem naj se napolnjena injekcijska brizga segreje na sobno temperaturo.
English: (pancytopaenia, anaemia, low platelet count, low white blood cell count)
Slovenian: krvavitve, bledica (pancitopenija, anemija, majhno število trombocitov, majhno število belih krvnih celic)
English: The total content (1 ml) of the pre-filled pen should be administered as a subcutaneous injection only.
Slovenian: Vsebino celega (1 ml) napolnjenega injekcijskega peresnika je treba aplicirati le v obliki subkutane injekcije.
English: Responders (achieved ACR 20) at week 16 were randomised at week 18 to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks, or placebo in combination with MTX for an additional 16 weeks (total trial length: 34 weeks).
Slovenian: Bolniki, ki so se odzvali na zdravljenje (dosegli ACR 20) v 16. tednu, so od 18. tedna naprej nadaljnih 16 tednov naključno prejemali 200 mg zdravila Cimzia vsaka 2 tedna, 400 mg zdravila Cimzia vsake 4 tedne ali placebo v kombinaciji z MTX (celoten čas preskušanja: 34 tednov).
English: The efficacy and safety of Cimzia were assessed in one multicenter, randomized, double-blind, placebo-controlled trial (AS001) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months as defined by the Assessment of Spondyloarthritis International Society (ASAS) Classification Criteria for axial spondyloarthritis.
Slovenian: Učinkovitost in varnost zdravila Cimzia so ocenili v multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanim preskušanjem (AS001) pri 325 bolnikih, starih ≥ 18 let, s pojavom aktivnega aksialnega spondiloartritisa v zadnjih 3 mesecih, ki je bil določen po kriterijih ocene v spondiloartritičnem mednarodnem združenju (ASAS - Assessment of Spondyloarthritis International Society) za aksialni spondiloartritis.
English: 879 400 mg (0,2,4 weeks) with MTX 200 mg every 2 weeks with MTX
Slovenian: 879 400 mg (0,2,4 tedni) z MTX 200 mg vsak drugi teden z MTX
English: Cimzia 200 mg + MTXPlacebo + MTX Mean Difference mTSS
Slovenian: Cimzia 200 mg + MTXPlacebo + MTX Srednja razlika mTSS
English: Physical function response and health-related outcomes In the AS001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the BASFI and in pain as assessed by the Total and Nocturnal Back Pain NRS scales as compared to placebo.
Slovenian: Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V primerjavi s placebom so bolniki pri AS001 kliničnem preskušanju, ki so se zdravili z zdravilom Cimzia, poročali o značilnih izboljšanjih telesnih funkcij, ocenjeno z BASFI, in značilnih izboljšanjih bolečine, ocenjeno s številčno lestvico (NRS) za celostno in nočno bolečino v križu.
English: • blood disorders
Slovenian: • obolenja krvi
English: Administration of Cimzia should be discontinued if a patient develops a new serious infection until the infection is controlled.
Slovenian: Če se pri bolniku pojavi nova resna okužba, moramo uporabo zdravila Cimzia prekiniti, dokler okužba ni pod nadzorom.
English: Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.
Slovenian: Rentgenske preiskave so pokazale, da zdravilo Cimzia v kombinaciji z MTX upočasni napredovanje poškodb sklepov in izboljša fizično funkcijo.
English: • Let go of the needle cap so that ava can push out the used medication.
Slovenian: • Spustite pokrovček igle, da bo naprava ava lahko izrinila ven uporabljen vložek.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 11.5%.
Slovenian: Celotni delež bolnikov, ki so bili pozitivni za protitelesa z vztrajnim zmanjšanjem plazemske koncentracije učinkovine, je bil ocenjen na 11,5 %.
English: • oral disorders including pain on swallowing
Slovenian: • obolenja ustne votline, vključno z bolečinami pri požiranju
English: *p<0.01, Cimzia vs placebo **p<0.001, Cimzia vs placebo ***p<0.001(nominal), Cimzia vs placebo
Slovenian: *p<0,01, zdravilo Cimzia v primerjavi s placebom **p<0,001, zdravilo Cimzia v primerjavi s placebom ***p<0,001(nominalno), zdravilo Cimzia v primerjavi s placebom Rezultati so iz naključnega niza.
English: Rare pericarditis, atrioventricular block Common hypertension Uncommo haemorrhage or bleeding (any site), hypercoagulation (including thrombophlebitis, pulmonary embolism), syncope, oedema (including peripheral, facial), ecchymoses (including haematoma, petechiae)
Slovenian: Srčne bolezni redke perikarditis, atrioventrikularni blok pogosti hipertenzija občasni krvavitev (na različnih mestih), hiperkoagulacija (vključno s tromboflebitisom in pljučno embolijo), sinkopa, edem (vključno s perifernim in facialnim edemom), ehimoze (vključno s hematomom in petehijami)
English: Antibody formation was associated with lowered drug plasma concentration.
Slovenian: Nastanek protiteles je bil povezan z znižano koncentracijo učinkovine v plazmi.
English: (On/Off button) for 1 second, or until the screen lights up and you hear sound - “Hello” is displayed for 2 seconds - this means ava is switched on.
Slovenian: - ˝Hello˝ se izpiše za 2 sekundi - to pomeni, da je naprava ava prižgana.
English: The efficacy and safety of Cimzia were assessed in a multicentre, randomised, double-blind, placebo controlled clinical trial (PsA001) in 409 patients ≥ 18 years of age with adult-onset active psoriatic arthritis for at least 6 months as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Slovenian: Učinkovitost in varnost zdravila Cimzia so ocenili v multicentričnem, randomiziranem, dvojno slepem, s placebom nadzorovanem kliničnem preskušanju (PsA001) pri 409 bolnikih, starih ≥ 18 let, s pojavom aktivnega psoriatičnega artritisa v zadnjih 6 mesecih, ki je bil določen po kriterijih ocene za psoriatični artritis (CASPAR).
English: If severe reactions occur, administration of Cimzia should be discontinued immediately and appropriate therapy instituted.
Slovenian: Če se te reakcije pojavijo, je treba zdravljenje z zdravilom Cimzia prekiniti in začeti z ustrezno terapijo.
English: In an integrated analysis of CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every other week, the maintenance response rates at Week 48 were 98.0% and 87.5%, respectively.
Slovenian: V integrirani analizi študije CIMPASI-1 in CIMPASI-2, so bile med bolniki, ki so imeli v 16. tednu odziv PASI 75, in so prejemali zdravilo Cimzia 400 mg vsaka 2 tedna ali zdravilo Cimzia 200 mg vsaki drugi teden, stopnje vzdrževanja odziva v 48. tednu 98,0 % oz. 87,5 %.
English: Patients had active disease as defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 NRS.
Slovenian: Bolniki so imeli aktivno bolezen po indeksu BASDAI ≥ 4 in bolečino v križu ≥ 4, ocenjeno s številčno lestvico (NRS) z vrednostmi od 0 do 10.
English: Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
Slovenian: Rezultati populacijske farmakokinetične analize niso pokazali vpliva sočasne uporabe metotreksata, kortikosteroidov, nesteroidnih protivnetnih zdravil (NSAID) in analgetikov na farmakokinetiko certolizumab pegola.
English: • lupus (immune/connective tissue disease) symptoms (joint pain, skin rashes, photosensitivity and fever)
Slovenian: • edem (otekanje obraza ali nog) • simptomi lupusa (imunska bolezen/ bolezen veznega tkiva) (bolečine v sklepih, kožni izpuščaj,
English: Suitable sites for injection would include the thigh or abdomen.
Slovenian: Med ustrezna mesta za injiciranje sodita stegno in trebuh.
English: • “Remove and save needle cap” is shown.
Slovenian: • Prikaže se ˝Remove and save needle cap˝ - Pokrovček igle odstranite samo takrat, ko ste pripravljeni na injiciranje.
English: Of the 138 patients randomised to Cimzia 200 mg every 2 weeks, 92, 68 and 48 had an ACR 20/50/70 response, at Week 48 respectively.
Slovenian: Od 138 bolnikov, ki je randomizirano prejemalo 200 mg zdravila Cimzia vsaka 2 tedna, jih je v 48. tednu 92 imelo odziv ACR 20, 68 odziv ACR 50 in 48 odziv ACR 70.
English: In both clinical trials, Cimzia-treated patients reported significantly greater improvements in the SF-36 Physical and Mental Component Summaries and all domain scores.
Slovenian: V obeh kliničnih študijah so pri bolnikih, ki so prejemali zdravilo Cimzia, na osnovi uporabe vprašalnika o splošnem zdravstvenem stanju SF-36 poročali o pomembnem izboljšanju rezultatov v vseh domenah.
English: Rare cholelithiasis Common rash Uncommo alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail and nail bed disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov redki holelitiaza pogosti izpuščaj občasni alopecija, nov pojav ali poslabšanje psoriaze (vključno s palmoplantarno pustulozno psoriazo) in z njo povezani simptomi, dermatitis in ekcem, motnje žlez znojnic, razjede kože, fotosenzitivna reakcija, akne, razbarvanost kože, suha koža, motnje nohtov in nohtne posteljice
English: **Cimzia+MTX vs placebo+MTX: p<0.001 p value was estimated from a logistic regression model with factors for treatment, region, and time since RA diagnosis at Baseline (≤4 months vs >4 months)
Slovenian: * Primarni cilj preskušanja C-EARLY (do 52. tedna) Popolna analiza, imputacija manjkajočih podatkov za bolnike **Cimzia+MTX v primerjavi s placebo + MTX: p<0.001 p vrednost je bila ocenjena z logistično regresijskim modelom s faktorji za zdravljenje, področje in čas od diagnoze RA v izhodiščni vrednosti (≤ 4 mesecev v primerjavi z > 4 mesecev)