natgillin/translations-raw huggingface dataset:
The safety profile for psoriatic arthritis patients treated with Cimzia was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Varnostni profil pri bolnikih s psoriatičnim artritisom, ki so bili zdravljeni z zdravilom Cimzia, je bil skladen z varnostnim profilom pri revmatoidnem artritisu in s prejšnjimi izkušnjami z zdravilom Cimzia.
Malignancies and lymphoproliferative disorders
Maligna in limfoproliferativna obolenja
Cimzia selectively neutralises TNFα (IC90 of 4 ng/ml for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralise lymphotoxin α (TNFβ).
Zdravilo Cimzia selektivno nevtralizira TNF-α (IC90 za zaviranje humanega TNF-α v in vitro testu citotoksičnosti na mišjih fibrosarkomskih celicah L929 je 4 ng/ml), vendar pa ne nevtralizira limfotoksina α (TNF).
Week 12 Week 24 ASAS 5/6(c,d)
12. teden 24. teden ASAS 5/6(c,d)
Read the instructions below carefully - this explains how to inject Cimzia by means of a dosedispenser cartridge.
Natančno preberite navodila spodaj - razloženo je, kako injicirati zdravilo Cimzia, ki ima odmerni vložek.
Patients with an inadequate response at Week 16 (PASI 50 non-responders) were eligible to receive Cimzia 400 mg every 2 weeks until Week 48 in an open label manner.
Bolniki z neustreznim odgovorom v 16. tednu (osebe, neodzivne pri PASI 50), so bili primerni za prejemanje zdravila Cimzia 400 mg vsaka 2 tedna do 48. tedna na odprti način.
If your doctor determines that methotrexate is inappropriate, Cimzia can be given alone.
Če se zdravnik odloči, da metotreksat ni primeren, se lahko zdravilo Cimzia jemlje samostojno.
It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulation.
Pri humanih monocitih ali limfocitih iz periferne krvi in vitro ne inducira apoptoze ali degranulacije nevtrofilcev.
mTSS: modified Total Sharp Score *Sustained remission at Week 52 is defined as DAS28[ESR] <2.6 at both Week 40 and Week 52.
Primarni cilj: delež oseb v trajnejši remisiji * po 52 tednih mTSS: modificirani celotni seštevek po Sharpu * Trajnejša remisija po 52 tednih je določena kot DAS28[ESR] < 2,6 po 40 tednih in po 52 tednih.
Patients treated with concomitant immunosuppressants (MTX) had a lower rate of antibody development than patients not taking immunosuppressants at baseline.
Bolniki, ki so se sočasno zdravili tudi z imunosupresivi (MTX), so imeli manjšo hitrost nastanka protiteles kot bolniki, ki se na začetku niso zdravili z imunosupresivi.
You might get an infection more easily while you are being treated with Cimzia, including serious, or in rare cases, life-threatening infections.
V času zdravljenja z zdravilom Cimzia se boste morda hitreje okužili; možne so tudi resne okužbe, ki lahko v redkih primerih ogrozijo vaše življenje.
ACR 20 p-value*
ACR 20 p-vrednost*
Do not heat the pre-filled syringe - let it warm on its own.
- Napolnjene brizge ne segrevajte - naj se segreje sama.
Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis
Revmatoidni artritis, psoriatični artritis, aksialni spondiloartritis, psoriaza v plakih
• When ready, remove the needle cap by pulling it firmly downwards.
• Ko ste pripravljeni, odstranite pokrovček igle tako, da ga močno povlečete navzdol.
Week 12 Week 24 BASDAI 50(c,d)
12. teden 24. teden BASDAI 50(c,d)
After suitable training, your doctor may allow you to inject Cimzia yourself.
Po ustreznem treningu injiciranja, vam bo zdravnik morda dovolil, da si zdravilo Cimzia injicirate sami.
ACR20 Week 12 Week 24 ACR50 Week 12 Week 24
ACR20 12. teden 24. teden ACR50 12. teden 24. teden
At Week 52, a statistically significant greater proportion of patients treated with Cimzia achieved ASDAS-MI response compared to patients treated with placebo.
V 52. tednu je statistično pomemben večji delež bolnikov, zdravljenih z zdravilom Cimzia, dosegel odziv ASDAS-MI v primerjavi z bolniki, ki so prejemali placebo.
In study-to-study comparison, the pharmacokinetics of certolizumab pegol appeared similar to those observed previously in healthy subjects.
Primerjava študij je pokazala, da je bila farmakokinetika certolizumab pegola podobna, kot so jo predhodno opazili pri zdravih prostovoljcih.
Patients receiving Cimzia and concomitant methotrexate had a lower humoral response compared with patients receiving Cimzia alone.
Bolniki, ki so bili sočasno zdravljeni z zdravilom Cimzia in metotreksatom, so imeli manjši humoralni odziv kot bolniki, ki so bili zdravljeni samo z zdravilom Cimzia.
Week 12 Week 24 ASAS40(c,d)
12. teden 24. teden ASAS40(c,d)
Effects on sperm motility measures and a trend of reduced sperm count in male rodents have been observed with no apparent effect on fertility (see section 5.3).
Pri samcih glodalcev so opazili učinke na rezultate meritev gibljivosti spermijev in tendenco zmanjševanja števila spermijev, vendar brez opaznega vpliva na plodnost (glejte poglavje 5.3).
In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups (0.07 per patient-year; all doses), compared with placebo (0.02 per patient-year).
V s placebom nadzorovanih kliničnih študijah je bilo več primerov resnih okužb v skupini, ki je dobivala zdravilo Cimzia (0,07 na bolnikovo leto; vsi odmerki) kot pa v skupini, ki je prejemala placebo (0,02 na bolnikovo leto).
Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankilozirajoči spondilitis (AS) (znan tudi kot radiografski aksialni spondiloartritis) Odrasli s hudim aktivnim ankilozirajočim spondilitisom, ki ne prenašajo nesteroidnih protivnetnih zdravil (NSAID), ali pa so imeli neustrezen odziv na NSAID.
Cimzia has not been studied specifically in a lupus population (see section 4.8).
Pri bolnikih z lupusom zdravila Cimzia niso posebej raziskovali (glejte poglavje 4.8).
• Do not remove the needle cap until ava instructs you to do so.
• Ne snemite pokrovčka, dokler vam naprava ava ne da navodila.
• If something is not clear - please ask your doctor or pharmacist.
• Če vam karkoli ni razumljivo - vprašajte zdravnika ali farmacevta.
Primary endpoint: ACR 20 at Week 24.
Primarni cilj: ACR 20 po 24 tednih
Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Cimzia se lahko uporablja kot monoterapija, kadar bolnik ne prenaša metotreksata ali kadar nadaljevanje zdravljenja z metotreksatom ni primerno.
Treatment success of “clear” (0) or “almost clear”(1) consisted of no signs of psoriasis or normal to pink coloration of lesions, no thickening of the plaque, and none to minimal focal scaling.
Uspeh zdravljenja "brez" (0) ali "skoraj brez" (1) je predstavljala odsotnost znakov psoriaze ali normalne do rožnato obarvane lezije, odsotnost odebeljenosti plaka in odsotnostali minimalno fokalno luščenje.
Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
Zdravilo Cimzia se lahko uporablja kot monoterapija, kadar bolnik ne prenaša MTX ali kadar nadaljevanje zdravljenja z MTX ni primerno.
- Do not twist the dose-dispenser cartridge - it is a special shape so that it fits correctly.
- Odmernega vložka ne vrtite - oblikovan je tako, da se pravilno prilega.
• anxiety and mood disorders such as depression, appetite disorders, weight change
• tesnoba in motnje razpoloženja, kot so depresija, motnje teka, spremembe telesne mase
Cimzia is contraindicated in moderate or severe heart failure (see section 4.3).
Zdravilo Cimzia je kontraindicirano pri bolnikih z zmernim ali hudim srčnim popuščanjem (glejte poglavje 4.3).
Do not heat the medication - let it warm up on its own Do not remove the cap until you are ready to inject.
- Napolnjenega injekcijskega peresnika ne segrevajte - naj se segreje sam. - Ne snemite pokrovčka, dokler niste pripravljeni na injiciranje.
Compared with a 70 kg person, clearance is 29% lower and 38% higher, respectively, in individual RA patients weighing 40 kg and 120 kg.
Pri bolnikih z RA, ki tehtata 40 kg oz. 120 kg, je očistek v primerjavi z bolnikom, ki tehta 70 kg, za 29 % nižji oz. 38 % višji.
Certolizumab pegol has a bioavailability (F) of approximately 80% (range 76% to 88%) following subcutaneous administration compared to intravenous administration.
Po subkutani aplikaciji je biološka uporabnost (F) certolizumab pegola v primerjavi z intravensko aplikacijo približno 80 % (območje med 76 % in 88 %).
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Pred začetkom zdravljenja z zdravilom Cimzia je treba bolnike testirati na okužbo s HBV. Za bolnike, ki so pozitivni na okužbo s HBV, je priporočljivo posvetovanje z zdravnikom, ki ima izkušnje z zdravljenjem hepatitisa B.
The two primary endpoints were the percentage of patients achieving ACR 20 response at Week 12 and change from baseline in modified Total Sharp Score (mTSS) at Week 24.
Dva primarna cilja študije sta bila odstotki bolnikov, ki so imeli odziv ACR 20 v 12. tednu, in sprememba od začetnega stanja v modificirani celotni Sharpovi oceni (mTSS) v 24. tednu.
- Wipe the injection site with an alcohol wipe, using a circular motion moving from the inside out.
- Mesto za injiciranje obrišite s priloženim alkoholnim zložencem, s krožnim gibom navzven.
ACR70 Week 12 Week 24
ACR70 12. teden 24. teden
- There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death (see further down “Children and adolescents”).
- Pri otrocih in mladostnikih, ki so jemali zaviralce TNF, so se pojavili primeri raka, vključno z neobičajnimi oblikami, ki so se včasih končali s smrtjo (glejte še spodaj »Otroci in mladostniki«).
In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
V obdobju trženja so poročali o primerih levkemije pri bolnikih, ki so se zdravili z zaviralci TNF.
In studies CIMPASI-1 and CIMPASI-2 the co-primary efficacy endpoints were the proportion of patients achieving PASI 75 and PGA “clear” or “almost clear” (with at least a 2-point reduction from baseline) at Week 16.
V študijah CIMPASI-1 in CIMPASI-2 sta bila sočasna opazovana dogodka učinkovitosti delež bolnikov, ki so v 16. tednu dosegli PASI 75 in PGA "brez" ali "skoraj brez" (z zmanjšanjem od izhodišča za vsaj 2 točki).
Cimzia should be used during pregnancy only if clearly needed.
Zdravilo Cimzia se sme uporabljati med nosečnostjo samo, če je nedvomno potrebno.
- The message “You have 1 injection left” will be shown on screen.
• Če vam je zdravnik predpisal tudi drugo injekcijo: - Sporočilo ˝ You have 1 injection left˝ se bo prikazalo na zaslonu.
Cimzia is used to treat rheumatoid arthritis.
Zdravilo Cimzia se uporablja za zdravljenje revmatoidnega artritisa.
Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.
Cimzia lahko povzroči lažno zvišane vrednosti testa aPTT pri bolnikih z motnjami koagulacije.
Cimzia is used to treat active psoriatic arthritis.
Zdravilo Cimzia se uporablja za zdravljenje aktivnega psoriatičnega artritisa.
Evaluation for treatment of signs and symptoms and inhibition of structural damage in DMARD naïve patients.
Ovrednotenje obravnavanja znakov in simptomov ter zaviranja strukturnih poškodb pri bolnikih, ki se predhodno niso zdravili z DMARD.
Co-primary endpoints: ACR 20 at Week 24 and change from baseline in mTSS at Week 52
Primarni končni cilji: ACR 20 po 24 tednih in spremembe mTSS glede na izhodiščno vrednost po 52 tednih
Among 273 patients initially randomised to Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks, 237 (86.8%) were still on this treatment at Week 48.
Med 273 bolniki, ki so na začetku randomizirano prejemali 200 mg zdravila Cimzia vsaka 2 tedna ali 400 mg zdravila Cimzia vsake 4 tedne, jih je bilo 237 (86,8 %) v 48. tednu še vedno na isti terapiji.
The incidence rate of new cases of infections in placebo-controlled clinical trials in psoriasis was 1,37 per patient-year for all Cimzia-treated patients and 1.59 per patient-year for placebo-treated patients.
Incidenca novih primerov okužb v s placebom nadzorovanih kliničnih preskušanjih psoriaze je bila 1,37 na bolnikovo leto za bolnike, zdravljene z zdravilom Cimzia, in 1,59 na bolnikovo leto za bolnike, zdravljene s placebom.
The incidence of serious infections was 0.02 per patient-year in Cimzia treated patients.
Incidenca resnih okužb je bila 0,02 na bolnikovo leto za bolnike, zdravljene z zdravilom Cimzia.
Activated partial thromboplastin time (aPTT) assay Interference with certain coagulation assays has been detected in patients treated with Cimzia.
Test za določanje aktiviranega delnega tromboplastinskega časa (aPTT) Pri bolnikih, ki so se zdravili z zdravilom Cimzia, so opazili interferenco z nekaterimi testi koagulacije.
If you forget to use Cimzia If you forget or miss an appointment to receive Cimzia, make another appointment as soon as possible.
Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Cimzia, se čimprej dogovorite za naslednjega.
If your doctor has allowed you to self-inject, you should follow up with your doctor before you continue to self-inject:
Če vam je zdravnik dovolil samoinjiciranje zdravila, se z zdravnikom pred nadaljevanjem samoinjiciranja posvetujte:
In the Phase III placebo- and active-controlled studies, the percentages of patients who were positive for antibodies to Cimzia on at least one occasion during treatment up to Week 48 were 8.3 % (22/265) and 19.2% (54/281) for the Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks respectively.
V s placebom in učinkovino nadzorovanih študijah faze III je bil odstotek bolnikov, ki so bili pozitivni za protitelesa proti zdravilu Cimzia ob vsaj eni priložnosti med zdravljenjem do 48. tedna, 8,3 % (22/265) za zdravilo Cimzia 400 mg vsaka 2 tedna in 19,2 % (54/281) za zdravilo Cimzia 200 mg vsaka 2 tedna.
The axial spondyloarthritis overall population included subpopulations with and without (non-radiographic axial spondyloarthritis [nraxSpA]) radiographic evidence for ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis).
Celotna populacija z aksialnim spondiloartritisom, vključuje podpopulaciji z ali brez (neradiografski aksialni spondiloartritis [nr-axSpA]) radiografskega dokaza za ankilozirajoči spondilitis (AS) (znan tudi kot radiografski aksialni spondiloartritis).
In a clinical study 16 women were treated with certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy.
V eni klinični študiji je 16 žensk med nosečnostjo prejemalo certolizumab pegol (200 mg vsaka 2 tedna ali 400 mg vsake 4 tedne).
There have been rare reports of other immunemediated conditions; the causal relationship to Cimzia is not known.
V redkih primerih so poročali o stanjih, ki so posredovana preko imunskega sistema, vendar njihova vzročna povezanost z zdravilom Cimzia ni znana.
The key results of the CIMPACT trial are presented in Table 12.
Ključni rezultati preskušanja CIMPACT so predstavljeni v Preglednici 12.
If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to:
Če se na ta zdravila ne odzovete dovolj dobro, boste dobili zdravilo Cimzia v kombinaciji z metotreksatom za:
Cimzia can be used during breastfeeding.
Zdravilo Cimzia se lahko uporablja med dojenjem.
Do NOT touch the needle guard activation clips (labelled as 3 in Figure 1) during removal (as shown in Figure 3) in order to prevent prematurely covering the needle with the needle guard.
Med odstranjevanjem (kot prikazuje Slika 3) se NE dotikajte aktivacijskih nastavkov za varovalo za iglo (označeno s 3 na Sliki 1), da predčasno ne zaprete igle z varovalom za iglo.
The combination of certolizumab pegol and anakinra or abatacept is not recommended (see section 4.4).
Kombinacija certolizumab pegola in anakinre ali abatacepta ni priporočljiva (glejte poglavje 4.4).
Not known Merkel cell carcinoma* Common eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia)
neznana karcinom Merklovih celic* pogosti eozinofilija, levkopenija (vključno z nevtropenijo in limfopenijo)
Cimzia treated patients also had significant improvements in ACR 50 and 70 response rates.
Bolniki, ki so se zdravili z zdravilom Cimzia , so imeli značilno izboljšanje v odzivu ACR 50 in odzivu ACR 70.
Children and adolescents Cimzia is not recommended for use in children and adolescents under the age of 18 years.
Otroci in mladostniki Uporaba zdravila Cimzia pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia and in accordance with local recommendations.
Če je diagnosticirana latentna tuberkuloza, je treba pred začetkom zdravljenja z zdravilom Cimzia v skladu z lokalnimi priporočili začeti z ustrezno profilakso proti tuberkulozi.
If you are a woman of childbearing potential, discuss with your doctor regarding use of adequate contraception while using Cimzia.
Če ste ženska v rodni dobi, se posvetujte s svojim zdravnikom o uporabi primerne oblike kontracepcije.
For both the Cimzia and placebo arms, MTX was initiated as of Week 0 (10 mg/week), titrated up to maximum tolerated dose by Week 8 (min 15 mg/week, max 25 mg/week allowed), and maintained throughout the study (average dose of MTX after Week 8 for placebo and Cimzia was 22.3 mg/week and 21.1 mg/week respectively).
Pri zdravilu Cimzia kot tudi pri placebu, se je zdravljenje z MTX začelo 0. teden (10 mg/teden), odmerek so povečevali do največjega sprejemljivega odmerka do 8. tedna (dovoljeno: najmanjši: 15 mg/teden, največji: 25 mg/teden) ter vzdrževali tekom študije (povprečni odmerek MTX po 8. tednu je bil pri placebu 22,3 mg/teden, pri zdravilu Cimzia pa 21,1 mg/teden).
- As the injection is being given, keep holding ava firmly against your skin.
- Med injiciranjem držite napravo ava tesno h koži.
Key results are presented in Table 9.
Ključni izsledki so predstavljeni v Preglednici 9.
Spinal mobility was assessed in the double-blind, placebo-controlled period by using BASMI at several time points including Baseline, Week 12 and Week 24.
Spinalna mobilnost je bila ocenjena v dvojno slepem, s placebom nadzorovanim obdobjem z uporabo BASMI v različnih časovnih točkah, in sicer na začetku zdravljenja, 12. teden in 24. teden.
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Zato je pri uporabi zaviralcev TNF pri bolnikih s KOPB ter pri bolnikih s povečanim tveganjem za nastanek malignega obolenja zaradi kajenja potrebna posebna pozornost.
Axial spondyloarthritis without radiographic evidence of AS (also known as non-radiographic axial spondyloarthritis)
Aksialni spondiloartritis brez radiografskega dokaza za AS (znan tudi kot neradiografski aksialni spondiloartritis)
• kidney and urinary problems including impairment of kidney function, blood in the urine and urinary disturbances
• obolenja sečil, vključno z okvarjenim delovanjem ledvic, krvjo v urinu in motnjami uriniranja
In the placebo group, 52% of patients experienced no radiographic progression (mTSS ≤ 0.0) at Week 52 compared to 69% in the Cimzia 200 mg treatment group.
V skupini, ki je prejemala placebo, pri 52 % bolnikov po 52 tednih ni bilo napredovanja (mTSS ≤0,0) v primerjavi z 69 % v skupini, ki je dobivala zdravilo Cimzia 200 mg.
All subjects who did not achieve a PASI 75 response at Week 16 entered an escape arm and received Cimzia 400 mg every 2 weeks.
Vse osebe, ki v 16. tednu niso dosegle odziva PASI 75, so vstopile v izhodni krak in so prejemale zdravilo Cimzia 400 mg vsaka 2 tedna.
If you do not respond well enough to these medicines, you will be given Cimzia in combination with methotrexate to treat your rheumatoid arthritis.
Če se ne odzovete dovolj dobro na ta zdravila, vam bodo za zdravljenje vašega revmatoidnega artritisa dali zdravilo Cimzia v kombinaciji z metotreksatom.
Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
V kombinaciji z metotreksatom (MTX) je zdravilo Cimzia namenjeno zdravljenju aktivnega psoriatičnega artritisa pri odraslih, pri katerih je bil odziv na imunomodulirajoča antirevmatična zdravila (DMARD) neustrezen.
• kidney problems (including nephritis)
• težave z ledvicami (vključno z nefritisom)
Do not try to touch the needle.
Ne poskušajte se dotakniti injekcijske igle.
Heart failure - If you have mild HEART FAILURE and you are being treated with Cimzia, your heart failure status must be closely monitored by your doctor.
Če imate blago SRČNO POPUŠČANJE in se zdravite z zdravilom Cimzia, mora zdravnik pozorno spremljati stanje vašega srčnega popuščanja.
Population pharmacokinetic analyses showed no effect of age (see section 5.2).
V celotni skupini bolnikov niso opazili vpliva starosti na farmakokinetiko (glejte poglavje 5.2).
Incubation of monocytes with Cimzia resulted in a dose-dependent inhibition of lipopolysaccharide (LPS)-induced TNFα and IL1β production in human monocytes.
Inkubacija monocitov s certolizumab pegolom vodi do inhibicije z lipopolisaharidi inducirane tvorbe TNF-α in IL-1β v humanih monocitih, ki je odvisna od odmerka.
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia.
Vsem bolnikom je treba svetovati, da naj med uporabo zdravila Cimzia v primeru pojava znakov in simptomov, ki kažejo na neravnovesje sestavin krvi ali na okužbo (npr. dalj časa trajajoča zvišana telesna temperatura, modrice, krvavitve, bledica), takoj poiščejo zdravniško pomoč.
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 16 weeks of treatment.
Pri bolnikih, ki v prvih 16 tednih ne kažejo znakov terapevtske koristi, je treba dobro razmisliti o nadaljevanju zdravljenja.
The potential role of TNF-antagonist therapy in the development of malignancies is not known.
Možen vpliv zdravljenja z zaviralci TNF na nastanek malignih obolenj ni znan.
In C-EARLY, Cimzia+MTX-treated patients reported significant improvements at Week 52 compared to placebo+MTX in pain as assessed by the Patient Assessment of Arthritis Pain (PAAP) - 48,5 vs44,0 (least square mean) (p<0.05).
V preskušanju C-EARLY so bolniki, ki so se zdravili z zdravilom Cimzia in MTX poročali o značilnih izboljšanjih glede bolečine v 52. tednu v primerjavi z bolniki, ki so prejemali placebo in MTX, kar je bilo ocenjeno z oceno bolečine pri bolnikih z artritisom (PAAP - Patient Assessment of Arthritis Pain), - 48,5 v primerjavi z - 44,0 (srednja vrednost najmanjših kvadratov) (p < 0,05).
Excluding non-melanoma skin cancer, 9 malignancies including 1 case of lymphoma were observed in the Cimzia psoriasis clinical trials in which a total of 1112 patients were treated, representing 1481 patient-years.
Razen nemelanomskega kožnega raka so v kliničnih preskušanjih psoriaze z zdravilom Cimzia opazili 9 malignih obolenj, vključno z 1 primerom limfoma, pri skupaj 1112 zdravljenih bolnikih, kar predstavlja 1481 bolnikovih let.
The 14-day half-life of certolizumab pegol should be taken into consideration if a surgical procedure is planned.
Pri načrtovanju operativnega posega je treba upoštevati 14-dnevno razpolovno dobo certolizumab pegola.