FrancophonIA/ELRC3.0 huggingface dataset:
English: Cimzia-treated patients reported significant improvements in tiredness (fatigue) as reported by the BASDAI-fatigue item and in health-related quality of life as measured by the ankylosing spondylitis QoL (ASQoL) and the SF-36 Physical and Mental Component Summaries and all domain scores as compared to placebo.
Slovenian: Bolniki, ki so se zdravili z zdravilom Cimzia, so poročali o značilnih izboljšanjih glede utrujenosti, ocenjeno z BASDAI indeksom-parameter utrujenost, in značilnih izboljšanjih kakovosti življenja v povezavi z zdravjem, ocenjeno z indeksom QoL za ankilozirajoči spondilitis (ASQoL) in na podlagi ocene telesne in duševne komponente SF-36.
English: NA = not available *p≤0.05, Cimzia vs placebo **p<0.001, Cimzia vs placebo
Slovenian: NA = ni na voljo *p≤ 0,05, zdravilo Cimzia v primerjavi s placebom **p<0,001, zdravilo Cimzia v primerjavi s placebom
English: Uncommo cardiomyopathies (including heart failure), ischaemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations
Slovenian: Ušesne bolezni, vključno z motnjami labirinta občasni tinitus, vertigo občasni kardiomiopatije (vključno s srčnim popuščanjem), ishemična obolenja koronarnih arterij, aritmije (vključno z atrijsko fibrilacijo), palpitacije
English: - Do not touch the area again before injecting.
Slovenian: - Pred injiciranjem se tega predela ne dotikajte več.
English: 982 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Slovenian: 982 400 mg (0,2,4 tedni) z MTX 200 mg ali 400 mg vsak drugi teden z MTX
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cimzia 200 mg injection certolizumab pegol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Cimzia 200 mg injekcija certolizumab pegol s.c.
English: All patients received Cimzia in both the dose-blind and openlabel follow-up periods.
Slovenian: Vsi bolniki so v za odmerek slepem obdobju in v obdobju odprtega zdravljenja prejemali zdravilo Cimzia.
English: N/A (a) Cimzia administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Cimzia administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (c) In subjects with at least 3% psoriasis BSA at Baseline
Slovenian: N/A (a) Odmerjanje zdravila Cimzia vsaka 2 tedna po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden (b) Odmerjanje zdravila Cimzia vsake 4 tedne po prejemanju polnilnega odmerka 400 mg na začetku zdravljenja, drugi in četrti teden (c) Bolniki, ki so imeli v izhodišču najmanj 3 % telesne površine prizadete s psoriazo
English: - You can change this speed using the “scroll wheel” on the side of your ava.
Slovenian: • Prikazana je trenutna hitrost injiciranja (hitrost pretok zdravila) - To hitrost lahko spreminjate z uporabo˝koleščka˝ob strani naprave ava.
English: Statistically significantly greater ACR 20 and ACR 50 responses were achieved from Week 1 and Week 2, respectively, in both clinical trials compared to placebo.
Slovenian: V primerjavi s placebom so bili v obeh kliničnih študijah doseženi statistično pomembnejši odzivi ACR 20 in ACR 50 po 1 oziroma 2 tednih.
English: 619 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Slovenian: 619 400 mg (0,2,4 tedni) z MTX 200 mg ali 400 mg vsak drugi teden z MTX
English: • If you feel unsure about the injection process, contact your doctor or pharmacist.
Slovenian: • Če ste negotovi glede postopka injiciranja, se posvetujte z zdravnikom ali farmacevtom.
English: - If the seal(s) is missing or broken - do not use and contact your pharmacist.
Slovenian: • Če manjka pečat ali če je zlomljen - ne uporabljajte in se posvetujte s farmacevtom.
English: Keep this Patient Reminder Card with you.
Slovenian: Opozorilno kartico za bolnika hranite pri sebi.
English: One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Slovenian: Ena napolnjena injekcijska brizga (steklo vrste I) z bromobutilnim gumijastim zamaškom in zaporko, ki vsebuje 200 mg certolizumab pegola.
English: Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Cimzia, so v redkih primerih poročali o nevroloških obolenjih, vključno z obolenji s konvulzijami, nevritisom in periferno nevropatijo.
English: * Cimzia vs placebo: p< 0.0001.
Slovenian: * Zdravilo Cimzia v primerjavi s placebom: p < 0,0001.
English: PGA clear or almost clear b) a) Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Week 0, 2, 4. b) PGA 5 category scale.
Slovenian: Ocena PGA brez ali skoraj čisto brez b) a) Zdravilo Cimzia 200 mg, uporabljeno vsaka 2 tedna po polnilnem odmerku 400 mg na začetku zdravljenja, v 2., 4. tednu.
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment.
Slovenian: Pri bolnikih, pri katerih v prvih 12 tednih zdravljenja ni terapevtskega učinka, je treba odločitev o nadaljevanju zdravljenja ponovno skrbno pretehtati.
English: Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Slovenian: Certolizumab pegol je fragment Fab' rekombinantnega, humaniziranega protitelesa proti tumorje nekrotizirajočem faktorju alfa (TNF-α).
English: - One or two pre-filled syringe(s), depending on your prescribed dose - One or two alcohol wipe(s)
Slovenian: ◦ eno ali dve napolnjeni injekcijski brizgi, odvisno od predpisanega odmerka ◦ en ali dva alkoholna zloženca
English: • Remove the needle cap from the needle by pulling off in a straight line.
Slovenian: • Z igle odstranite pokrovček tako, da ga potegnete naravnost.
English: Serious infections, including sepsis and tuberculosis (including miliary, disseminated and extrapulmonary disease), and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Cimzia, so poročali o pojavu resnih okužb, tuberkuloze (vključno z miliarno, diseminirano in ekstrapulmonalno obliko) in oportunističnih okužb (na primer histoplazmoza, nokardije, kandidiaza), ki so bile v nekaterih primerih smrtne.
English: Cimzia 400 mg + MTX every 4 weeks N=69
Slovenian: Cimzia 400 mg + MTX vsake 4 tedne n = 69
English: • heart problems including weakened heart muscle, heart failure, heart attack, chest discomfort or chest pressure, abnormal heart rhythm including irregular heart beats
Slovenian: tiščanje ali pritisk v prsih, motnje srčnega ritma, vključno z nepravilnim srčnim utripom
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).
Slovenian: Po prejemanju zdravila Cimzia se lahko pojavi omotičnost (vključno z vertigom, motnjami vida in utrujenostjo) (glejte poglavje 4.8).
English: If the seal(s) is missing or broken - do not use and contact your pharmacist.
Slovenian: - Če manjka pečat ali če je zlomljen - ne uporabljajte in se posvetujte s farmacevtom.
English: Physical function response and health-related outcomes In RA-I and RA-II, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) from Week 1 through to the end of the studies compared to placebo.
Slovenian: Odziv v obliki fizične funkcije in z zdravstvenim stanjem povezani izidi V študijah RA-I in RA-II je bilo v primerjavi s placebom od 1. tedna do konca študij opaziti pomembno izboljšanje fizične funkcije, ki so jo pri bolnikih, ki so dobivali zdravila Cimzia, ovrednotili z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (Health Assessment Questionnaire - Disability Index (HAQ-DI)), ter utrujenosti po lestvici FAS.
English: However, do not inject in an area where the skin is reddened, bruised, or hard.
Slovenian: Vendar pa si zdravila ne injicirajte v predel kože, ki je pordel, podplut ali otrdel.
English: Patients had ≥ 9 swollen and tender joints each and had active RA for at least 6 months prior to baseline.
Slovenian: V najmanj 9 primerih so bolniki imeli otečene in boleče sklepe ter aktivni revmatoidni artritis vsaj 6 mesecev pred začetkom zdravljenja.
English: The pre-filled syringe contains 200 mg of certolizumab pegol.
Slovenian: Napolnjena injekcijska brizga vsebuje 200 mg certolizumab pegola.
English: In the overall population, the percentage of ASAS20 responders was clinically relevant and significantly higher for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit from Week 1 through Week 24 (p≤0.001 at each visit).
Slovenian: V celotni populaciji je bil delež odzivov ASAS20 klinično pomemben in značilno višji pri vsakem obisku od 1. tedna do 24. tedna (p ≤ 0,001 pri vsakem obisku) v skupini, ki je prejemala zdravilo Cimzia 200 mg vsaka 2 tedna in v skupini, ki je prejemala zdravilo Cimzia 400 mg vsake 4 tedne, v primerjavi s skupino, ki je prejemala placebo.
English: Etanercept 50 mg BiW N=170
Slovenian: Etanercept 50 mg dvakrat na teden n = 170
English: • gastrointestinal obstructions (blockages of the digestive system).
Slovenian: • obstrukcija prebavne poti (zapora prebavnega sistema)
English: Patients received loading doses of Cimzia 400 mg at weeks 0, 2, and 4 followed by Cimzia 200 mg every 2 weeks during the initial open label period.
Slovenian: Bolniki so prejemali polnilni odmerek zdravila Cimzia 400 mg na začetku zdravljenja, 2. in 4. teden, ki mu je sledilo 200 mg zdravila Cimzia vsaka 2 tedna med začetnim odprtim obdobjem.
English: Sustained remission* (DAS28(ESR) <2.6 at both Week 40 and Week 52) Sustained low disease activity (DAS28(ESR) ≤3.2 at both Week 40 and Week 52) *Primary endpoint of C-EARLY trial (to Week 52) Full analysis set, non-responder imputation for missing values.
Slovenian: Trajnejša manjša aktivnost bolezni (DAS28(ESR) ≤ 3,2 po 40 tednih in 52 tednih) * 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)
English: The 24-week double-blind, placebo-controlled treatment period of the study was followed by a 24week dose-blind treatment period, and a 156-week open-label treatment period.
Slovenian: 24-tedenskemu dvojno slepemu, s placebom nadzorovanem obdobju zdravljenja je sledilo 24-tedensko za odmerek slepo obdobje in 156-tedensko obdobje odprtega zdravljenja.
English: What Cimzia is and for what it is used for What you need to know before you use Cimzia How to use Cimzia
Slovenian: Kaj je zdravilo Cimzia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cimzia Kako uporabljati zdravilo Cimzia Možni neželeni učinki
English: • nausea
Slovenian: • krči
English: • bleeding or bruising
Slovenian: • krvavitve ali nastajanje modric
English: MTX should be continued during treatment with Cimzia where appropriate.
Slovenian: Po potrebi bolnik med zdravljenjem z zdravilom Cimzia še naprej prejema MTX.
English: Over the course of the entire study (up to 4 years of exposure), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 17.3% (8.7% had transient formation and an additional 8.7% had persistent formation of antibodies to Cimzia).
Slovenian: Tekom študije (do 4 let izpostavljenosti) je bil celotni delež bolnikov, pri katerih so odkrili protitelesa proti zdravilu Cimzia vsaj v enem primeru, 17,3 % (8,7 % je imelo prehoden nastanek protiteles in dodatnih 8,7 % je imelo vztrajno nastajanje protiteles proti zdravilu Cimzia).
English: Patients were randomized to receive placebo, or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4), or Cimzia 400 mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 12.
Slovenian: Bolniki so bili randomizirani za prejemanje placeba ali zdravila Cimzia 200 mg vsaka 2 tedna (po polnilnem odmerku zdravila Cimzia 400 mg na začetku zdravljenja, v drugem in četrtem tednu), ali zdravila Cimzia 400 mg vsaka 2 tedna do 16 tednov, ali etanercepta 50 mg dvakrat na teden do 12 tednov.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9.1%.
Slovenian: Skupni odstotek bolnikov, ki so bili pozitivni na protitelesa in se jim je trajno zmanjševala koncentracija učinkovine v plazmi, je bil ocenjen na 9,1 %.
English: • nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation,
Slovenian: • obolenja živcev v okončinah, vključno s simptomi omrtvičenosti, mravljinčenja, pekočim občutkom, omotičnostjo, tremorjem
English: Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 (see Table 5).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Cimzia, je bil po 24. oziroma 52. tednu obseg napredovanja bistveno manjši kot pri bolnikih, ki so dobivali placebo (glejte preglednico 5).
English: After the starting dose, the recommended maintenance dose of Cimzia for adult patients with axial spondyloarthritis is 200 mg every 2 weeks or 400 mg every 4 weeks.
Slovenian: Po začetnem odmerku je priporočeni vzdrževalni odmerek zdravila Cimzia pri odraslih bolnikih z aksialnim spondiloartritisom 200 mg vsaka 2 tedna ali 400 mg vsake 4 tedne.
English: The following instructions explain how to inject Cimzia.
Slovenian: Navodila, ki so pred vami, opisujejo postopek injiciranja zdravila Cimzia.
English: Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving Cimzia.
Slovenian: Pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo Cimzia, so prav tako poročali o poslabšanjih kongestivnega srčnega popuščanja.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least 1 occasion was 9.6% in RA placebo-controlled trials.
Slovenian: V s placebom nadzorovanih preskušanjih pri revmatoidnem artritisu je bil skupen odstotek bolnikov, pri katerih so bila vsaj ob eni priložnosti prisotna protitelesa, 9,6 %.
English: • Allow the AutoClicks pre filled pen(s) to reach room temperature.
Slovenian: • Pred injiciranjem naj se napolnjeni injekcijski peresnik AutoClicks segreje na sobno temperaturo.
English: • flu-like symptoms, chills, altered temperature perception, night sweats, flushing
Slovenian: • otekli limfni vozli • gripi podobni simptomi, mrzlica, spremembe v zaznavi temperature, nočno potenje, vročinski valovi
English: At week 12 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Cimzia-treated patients (nominal p-value p<0.01).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Cimzia (nominalna p-vrednost p<0,01), so v 12. tednu in 24. tednu opazili izboljšanje v parametrih periferne aktivnosti pri psoriatičnem artritisu (npr. število oteklih sklepov, število bolečih/občutljivih sklepov, daktilitis in entezitis).
English: (difference between etanercept and Cimzia 200 mg every 2 weeks was 8.0%, 95% CI -2.9, 18.9, based on a pre-specified non-inferiority margin of 10%).
Slovenian: § Zdravilo Cimzia 200 mg vsaka 2 tedna v primerjavi z etanerceptom 50 mg dvakrat na teden se je izkazalo za neinferiorno (razlika med etanerceptom in zdravilom Cimzia 200 mg vsaka 2 tedna je bila 8,0 %, 95 % IZ -2,9,, 18,9, na podlagi predhodno opredeljene meje neinferiornosti 10 %).
English: Medication level indicator 3.
Slovenian: 1. končni pokrovček 2. indikator nivoja zdravila 3. brizga
English: At Week 52, patients treated with Cimzia showed a clinical meaningful improvement in the MASES compared to placebo (LS mean change from baseline -2.4; -0.2 respectively).
Slovenian: V 52. tednu so bolniki, zdravljeni z zdravilom Cimzia, pokazali klinično pomembno izboljšanje MASES v primerjavi s skupino, ki je prejemala placebo (sprememba povprečne razlike od začetne vrednosti je znašala -2,4 pri bolnikih, zdravljenih z zdravilom Cimzia in -0,2 pri bolnikih, ki so prejemali placebo).
English: The incidence rate of new cases of infections in placebo-controlled clinical trials in rheumatoid arthritis was 1.03 per patient-year for all Cimzia-treated patients and 0.92 per patient-year for placebotreated patients.
Slovenian: V s placebom nadzorovanih kliničnih študijah pri revmatoidnem artritisu je bila pri bolnikih, ki so prejemali zdravilo Cimzia, pogostnost novih okužb 1,03 na bolnikovo leto, pri bolnikih, ki so prejemali placebo, pa 0,92 na bolnikovo leto.
English: The efficacy and safety of Cimzia was assessed in DMARD-naïve adult patients with active RA in a randomized, placebo-controlled, double-blind clinical trial (C-EARLY).
Slovenian: Učinkovitost in varnost zdravila Cimzia so ocenili v randomiziranem, s placebom nadzorovanem, dvojno slepem kliničnem preskušanju (C-EARLY) pri odraslih bolnikih z aktivnim RA, ki se predhodno niso zdravili z antirevmatiki DMARD.
English: Allergic reactions - If you experience ALLERGIC REACTIONS such as chest tightness, wheezing, dizziness,
Slovenian: Alergijske reakcije - Če imate ALERGIJSKE REAKCIJE, kot so tiščanje v prsih, piskanje, omotičnost, otekanje ali izpuščaj, uporabo zdravila Cimzia prekinite in TAKOJ obvestite svojega zdravnika.
English: Cimzia is provided as a solution for injection in a ready to use pre-filled pen (AutoClicks).
Slovenian: Zdravilo Cimzia je raztopina za injiciranje v napolnjenem injekcijskem peresniku (AutoClicks) za takojšnjo uporabo.
English: Your doctor should test you for HBV before starting Cimzia.
Slovenian: Pred zdravljenjem z zdravilom Cimzia vas mora zdravnik testirati na okužbo s HBV.
English: • coughing
Slovenian: • kašelj
English: Response Placebo + MTX N=199
Slovenian: Placebo + MTX n = 199
English: In the CIMPACT study, among PASI 75 responders at Week 16 who received Cimzia 400 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (98.0%, 80.0%, and 36.0%, respectively).
Slovenian: V študiji CIMPACT je bil med odzivnimi osebami PASI 75 v 16. tednu, ki so prejemale zdravilo Cimzia 400 mg vsaka 2 tedna in so bile ponovno randomizirane za zdravilo Cimzia 400 mg vsaka 2 tedna, zdravilo 200 mg vsaka 2 tedna ali placebo, večji odstotek odzivnih oseb PASI 75 v 48. tednu v skupinah z zdravilom Cimzia v primerjavi s placebom (98,0 %; 80,0 % oz. 36,0 %).
English: Cimzia 200 mg + MTX N=393 Mean (SD)
Slovenian: Cimzia 200 mg + MTX n = 393 Srednja vrednost (SD)
English: Haematological reactions
Slovenian: Hematološki pojavi
English: Cimzia contains the active substance certolizumab pegol, a human antibody fragment.
Slovenian: Zdravilo Cimzia vsebuje učinkovino certolizumab pegol, ki je del humaniziranega protitelesa.
English: If you feel unsure about the injection process, please contact your doctor or pharmacist.
Slovenian: Če ste negotovi glede postopka injiciranja, se posvetujte z zdravnikom ali farmacevtom.
English: How Cimzia is given
Slovenian: Kako se daje zdravilo Cimzia
English: Rare nephropathy (including nephritis)
Slovenian: Bolezni sečil redki nefropatija (vključno z nefritisom)
English: §§ Cimzia 400 mg every 2 weeks versus etanercept 50 mg twice weekly demonstrated superiority
Slovenian: §§ Zdravilo Cimzia 400 mg vsaka 2 tedna v primerjavi z etanerceptom 50 mg dvakrat na teden se je izkazalo za superiorno (p < 0.05).
English: Over the course of the entire study (up to 192 weeks), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.6% (4.8% had transient formation and an additional 4.8% had persistent formation of antibodies to Cimzia).
Slovenian: Tekom študije (do 192 tednov) je bil celotni delež bolnikov, pri katerih so odkrili protitelesa proti zdravilu Cimzia vsaj v enem primeru, 9,6 % (4,8 % je imelo prehodno nastajanje protiteles in dodatnih 4,8 % je imelo vztrajno nastajanje protiteles proti zdravilu Cimzia).
English: Cimziaa 200 mg every 2 weeks N= 159
Slovenian: Cimziaa 200 mg vsaka 2 tedna N= 159
English: Among PASI75 responders at Week 16 who received Cimzia 200 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 4 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (88.6%, 79.5%, and 45.5%, respectively).
Slovenian: Tudi med odzivnimi osebami PASI 75 v 16. tednu, ki so prejemale zdravilo Cimzia 200 mg vsaka 2 tedna in so bile ponovno randomizirane za zdravilo Cimzia 400 mg vsake 4 tedne, zdravilo Cimzia 200 mg vsaka 2 tedna ali placebo, je bil večji odstotek odzivnih oseb PASI 75 v 48. tednu v skupini z zdravilom Cimzia v primerjavi s placebom (88,6 %; 79,5 % oz. 45,5 %).
English: • thyroid disorders (goitre, tiredness, weight loss)
Slovenian: • motnje v delovanju ščitnice (golša, utrujenost, hujšanje)
English: The 24-week double-blind placebo controlled treatment period of the study was followed by a 24week dose-blind treatment period and an 168-week open-label treatment period.
Slovenian: 24-tedenskemu dvojno slepemu, s placebom nadzorovanem obdobju zdravljenja je sledilo 24-tedensko za odmerek slepo obdobje in 168-tedensko obdobje odprtega zdravljenja.
English: Non-radiographic AxSpA
Slovenian: Neradiografski aksialni spondiloartritis (nr-axSpA)
English: Cimzia 200 mg + MTX N = 528 Mean (SD)
Slovenian: Cimzia 200 mg + MTX n = 528 Srednja vrednost (SD)
English: Rare suicide attempt, delirium, mental impairment Common headaches (including migraine), sensory abnormalities Uncommo peripheral neuropathies, dizziness, tremor
Slovenian: Psihiatrične motnje redki suicidalnost, delirij, duševne motnje pogosti glavobol (vključno z migreno), motnje zaznavanja
English: In the pivotal studies, for subjects who were ANA negative at baseline, 16.7% of those treated with Cimzia developed positive ANA titers, compared with 12.0% of subjects in the placebo group.
Slovenian: V pivotnih študijah so bila ob koncu zdravljenja pri bolnikih, ki so bili pred zdravljenjem negativni, prisotna antinuklearna protitelesa, in sicer pri 16,7 % bolnikov, ki so prejemali zdravilo Cimzia, in pri 12 % tistih, ki so prejemali placebo.
English: Cimzia-treated patients reported significant improvements in axial spondyloarthritis-related productivity at work and within household, as reported by the Work Productivity Survey as compared to placebo.
Slovenian: V primerjavi s placebom so bolniki z aksialnim spondiloartritisom, ki so se zdravili z zdravilom Cimzia, v študiji o produktivnosti pri delu poročali o značilnih izboljšanjih produktivnosti pri delu in v gospodinjstvu.
English: Injecting the solution subcutaneously with air bubbles is harmless.
Slovenian: Subkutano injiciranje raztopine z mehurčki ni škodljivo.
English: Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet.
Slovenian: Obsežna navodila za pripravo in uporabo zdravila Cimzia v obliki napolnjene injekcijske brizge so podana v navodilu za uporabo.
English: Biological tests for tuberculosis screening should be considered before starting Cimzia treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.
Slovenian: Če obstaja možnost latentne tuberkulozne okužbe kljub cepljenju proti tuberkulozi, je treba pred začetkom zdravljenja z zdravilom Cimzia razmisliti o bioloških testih za presejanje na prisotnost tuberkuloze.