natgillin/translations-raw huggingface dataset:
For the above indications, available data suggest that clinical response is usually achieved within 12 weeks of treatment. 
Za zgoraj omenjene indikacije kažejo razpoložljivi podatki, da klinični odziv običajno dosežemo v 12 tednih po uvedbi zdravljenja.
ASDAS-MI Week 52 
ASDAS-MI 52. teden
Therefore, reproductive toxicology studies have been performed with a homologous reagent recognising rat TNF. 
Zato so reproduktivne toksikološke študije izvedli s homolognim reagentom, ki prepozna podganji TNF.
For details on therapeutic effects, see section 5.1. 
Za podrobnosti glede terapevtskih učinkov glejte poglavje 5.1.
A total of 264 subjects (64.5%) completed the study through Week 216. 
264 preiskovancev (64,5 %) je zaključilo študijo v 216. tednu.
ASDAS-MI response was defined as an ASDAS reduction (improvement) ≥ 2.0 relative to baseline or as reaching the lowest possible score. 
Odziv ASDAS-MI je bil opredeljen kot zmanjšanje ASDAS (izboljšanje) ≥ 2,0 glede na izhodiščno vrednost ali kot doseganje najnižje možne ocene.
The most frequent serious infections included pneumonia, tuberculosis infections. 
Med najpogostejšimi resnimi okužbami so bile pljučnica, tuberkuloza.
• vertigo (dizziness) 
• vertigo (vrtoglavica)
The results at week 34 are shown in Table 7. 
Rezultati 34. tedna so prikazani v Preglednici 7.
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. 
Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni in je običajno smrtna.
Patient numbers 
Številka bolnika
However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy. 
Vendar so klinične izkušnje, ki so na voljo, preveč omejene, da bi z razumno gotovostjo lahko zaključili, da povečanega tveganja, povezanega z uporabo zdravila Cimzia med nosečnostjo, ni.
Patients who were ‘primary' non-responders on any prior biologic therapy (defined as no response within the first 12 weeks of treatment) were excluded from the phase III studies (CIMPASI-1, CIMPASI-2 and CIMPACT). 
Bolniki, ki so bili 'primarno' neodzivni za vsako predhodno biološko zdravljenje (opredeljeno kot brez odziva v prvih 12 tednih zdravljenja), so bili iz študij faze III (CIMPASI-1, CIMPASI-2 in CIMPACT) izključeni.
RA-II (24 weeks) 
RA-II (24 tednov)
Mean baseline BSA was 25% and ranged from 10% to 96%. 
Povprečni BSA ob izhodišču je bil 25 % in je bil v razponu od 10 % do 96 %.
This is so that the doctor can determine if Cimzia is working for you or if another treatment needs to be considered. 
Namen tega je, da zdravnik ugotovi, ali zdravilo Cimzia pri vas učinkuje ali pa je treba razmisliti o drugem zdravljenju.
Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region. 
p-vrednosti po Waldu so navedene za primerjavo zdravil ob uporabi logistične regresije s faktorji za zdravljenje in regijo.
The maximum duration of the study was 216 weeks. 
Najdaljše trajanje študije je bilo 216 tednov.
This number decreases with increasing doses of concomitant MTX treatment. 
To število se zmanjšuje s povečanjem odmerkov sočasno apliciranega MTX.
• sepsis (serious infection which can result in organ failure, shock or death) 
• sepsa (huda okužba, ki ima lahko za posledico odpoved organov, šok ali smrt)
This injection should not be mixed in the same syringe with any other medicine. 
Tega zdravila ne smete mešati v isti injekcijski brizgi z drugimi zdravili.
Interference with thrombin time (TT) and prothrombin time (PT) assays have not been observed. 
Interference s testi določanja trombinskega časa (TT) in protrombinskega časa (PT) niso opazili.
- Once the needle cap has been removed, you must give the injection within 5 minutes. 
- Ko je pokrovček igle odstranjen, morate injicirati v roku 5 minut.
See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C. 
Glejte tudi poglavje 6.4 glede roka uporabnosti za shranjevanje pri sobni temperaturi do 25 °C.
• Place the orange skin sensor against the injection site where you are going to inject. 
• Namestite oranžni senzor kože na mesto injiciranja, kjer nameravate injicirati.
If the viewing window turns orange and you hear a second click this means the injection has been completed. 
Če se okence obarva oranžno in slišite drugi ˝klik˝, to pomeni, da je bilo injiciranje končano.
• Merkel cell carcinoma (a type of skin cancer)* 
• karcinom Merklovih celic (vrsta kožnega raka)*
- You can choose “slowest”, “slow”, “fast” or “fastest” - this controls how fast the medicine will be injected and should be selected (and adjusted) as per your personal comfort preference. 
- Izberete lahko ˝najpočasneje˝, ˝počasi˝, ˝hitro˝ali ˝najhitreje˝ - s tem je nadzorovana hitrost injiciranja zdravila in izberete jo (prilagodite), kakor vam najbolj ustreza.
If you take Cimzia, your risk of getting lymphoma or other cancers may increase. 
Če jemljete zdravilo Cimzia, se lahko tveganje za nastanek limfoma ali drugih vrst raka poveča.
Data from more than 500 prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, does not indicate a malformative effect of Cimzia. 
Podatki iz več kot 500 prospektivno zbranih nosečnosti, pri katerih so bile ženske izpostavljene zdravilu Cimzia, z znanim izidom nosečnosti, vključno z več kot 400 nosečnostmi, pri katerih so bile ženske izpostavljene v prvem trimesečju, ne kažejo na malformacijski učinek zdravila Cimzia.
Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex. 
Stik z naravnim lateksom lahko pri osebah, občutljivih na lateks, povzroči resne alergijske reakcije.
- If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia. 
- Če imate bolezni živčevja, kot je multipla skleroza, se bo vaš zdravnik odločil, ali lahko uporabljate zdravilo Cimzia.
• Release the skin with the first hand. 
• S prvo roko sprostite kožo.
As clearance decreases with decreasing body weight, females may generally obtain somewhat higher systemic exposure of certolizumab pegol. 
Ker se pri manjši telesni teži zmanjša tudi očistek, je lahko pri ženskah na splošno sistemska izpostavljenost certolizumab pegolu do določene mere večja.
• fungal infections (occur when the ability to fight off infection is lessened) 
• glivične okužbe (pojavijo se, kadar je sposobnost organizma za obrambo pred okužbami zmanjšana)
Cimzia will be given to you by your doctor or nurse, in hospital or clinic. 
Zdravilo Cimzia vam bo dal vaš zdravnik ali medicinska sestra v bolnišnici ali ambulanti.
• muscle problems including increased muscle enzymes 
• mišična obolenja, vključno s povečanimi vrednostmi mišičnih encimov
PASI75 and PGA at Week 16 were key secondary endpoints. 
PASI 75 in PGA v 16. tednu sta bila ključna sekundarna opazovana dogodka.
The results of clinical trials RA-I and RA-II are shown in Table 3. 
Rezultati kliničnih študij RA-I in RA-II so prikazani v preglednici 3.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 2009 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 01 oktober 2009 Datum zadnjega podaljšanja: 16 maj 2014
Patients had ≥ 3 swollen and tender joints and increased acute phase reactants. 
Bolniki so imeli ≥ 3 otekle in boleče sklepe ter zvišane reaktante akutne faze.
• increased iron levels in the body 
• zvišana vrednost železa v telesu
Table 4: C-EARLY trial: percent of patients in sustained remission and sustained low disease activity at Week 52 
Preglednica 4 Preskušanje C-EARLY: Delež bolnikov s trajnejšo remisijo in trajnejšo manjšo aktivnostjo bolezni v 52. tednu
Table 2 Clinical trial description Study number 
Preglednica 2 Opis klinične študije Številka študije
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
• tuberculosis infection 
• okužba s tuberkulozo
The difference from placebo tended to be greater in nr-axSpA than in the AS subpopulation which may be due to less chronic structural damage in nr-axSpA patients. 
Razlike v placebo skupini so bile večje pri nr-axSpA kot pri AS podpopulaciji, kar je lahko posledica manjših kroničnih strukturnih sprememb pri nr-axSpA bolnikih.
Cimzia is used to reduce skin inflammation and other signs and symptoms of your disease. 
Zdravilo Cimzia se uporablja za zmanjšanje kožnega vnetja ter drugih znakov in simptomov bolezni.
About 22% (54/248) of the patients who were anti-certolizumab pegol antibody positive at any time, had antibodies that were classified as neutralizing. 
Okoli 22 % bolnikov (54/248), ki so bili kadar koli pozitivni na protitelesa proti certolizumab pegolu, je imelo protitelesa, ki so bila razvrščena kot nevtralizirajoča.
Patients were predominantly men (64%) and Caucasian (94%), with a mean age of 45.7 years (18 to 80 years); of these, 7.2% were ≥ 65 years of age. 
Bolniki so bili pretežno moški (64 %) in belci (94 %), s povprečno starostjo 45,7 let (18 do 80 let); med njimi je bilo 7,2 % starih ≥ 65 let.
ASAS 40 Week 12 
ASAS 40 12. teden
Hold the pre-filled pen straight (at a 90° degree angle) against the skin, that previously has been cleaned (the “injection site”). 
Držite napolnjeni injekcijski peresnik h koži (pod kotom 90 stopinj), ki je bila predhodno očiščena (mesto injiciranja).
Missing data were imputed using multiple imputation based on the MCMC method. 
Manjkajoči podatki so bili vstavljeni z multiplo imputacijo na podlagi metode MCMC.
When assessed using the previous ELISA method, the presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance. 
Pri ocenjevanju s prej omenjeno metodo ELISA prisotnost protiteles proti certolizumab pegolu vodi do približno trikratnega povečanja očistka.
47% had received prior phototherapy or chemophototherapy, and 30% had received prior biologic therapy for the treatment of psoriasis. 
47 % jih je predhodno prejemalo fototerapijo ali kemofototerapijo in 30 % je predhodno prejemalo biološka zdravila za zdravljenje psoriaze.
• formation of stones in the gall bladder 
• nastanek kamnov v žolčniku
Evaluation for treatment of signs and symptoms and inhibition of structural damage. 
Ovrednotenje obravnavanja znakov in simptomov ter zaviranja strukturnih poškodb.
Subject who escaped or withdrew (based on not achieving PASI 50 response) were treated as non-responders at Week 48. 
Osebe, ki so se prešle v izhodno skupino ali so prenehale sodelovati (zaradi nedoseganja odziva PASI 50) so bile obravnavane kot neodzivne osebe v 48. tednu.
• Do not use the medication if it has been dropped after taking it out of the pack. 
• Zdravila ne uporabljajte, če vam je padlo, potem ko ste ga vzeli iz pakiranja.
Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of infections. 
Pri zdravljenju starejših bolnikov je potrebna posebna pozornost, zlasti glede pojava okužb.
The injection begins when a first “click” is heard and the orange band at the bottom of the pre-filled pen disappears. 
Injiciranje se začne, ko zaslišite prvi ˝klik˝ in oranžni trak na dnu napolnjenega injekcijskega peresnika izgine.
If you have COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you. 
Če imate KOPB ali ste hud kadilec, se posvetujte z zdravnikom o tem, če je zdravljenje z zaviralcem TNF za vas primerno.
• general physical health deterioration. 
• poslabšanje splošnega zdravstvenega stanja
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. 
Drugi primeri vključujejo množico različnih malignih obolenj in redka maligna obolenja, ki jih običajno povezujejo z imunosupresijo.
• Remove the Cimzia pack from the refrigerator. 
• Vzemite pakiranje zdravila Cimzia iz hladilnika.
Table 9: ASDAS-MI and ASAS 40 responses in AS0006 (percent of patients) 
Preglednica 9 Odzivi ASDAS-MI in ASAS 40 v AS0006 (odstotek bolnikov) Parametri
Table 3 ACR response in clinical trials RA-I and RA-II Study RA-I Methotrexate combination (24 and 52 weeks) 
Preglednica 3 Odziv ACR v kliničnih študijah RA-I in RA-II Študija RA-I Kombinacija z metotreksatom (24. in 52. teden)
Then, talk to your doctor and inject the following doses as instructed. 
Nato se z zdravnikom posvetujte in si po navodilih injicirajte naslednje odmerke.
Check the medicine in the body of the syringe. 
Preverite zdravilo v telesu injekcijske brizge.
• When the injection is complete, a message is shown on ava's screen saying "Injection complete. 
• Ko je injiciranje zaključeno, se na ava zaslonu prikaže sporočilo ˝Injection complete.
Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period (see section 4.3). 
Ker se certolizumab pegol iz telesa lahko izloča do 5 mesecev, je potrebno bolnika ves ta čas pozorno spremljati (glejte poglavje 4.3).
If you experience these symptoms, contact your doctor. 
Če se ti simptomi pojavijo, se posvetujte s svojim zdravnikom.
The typical Cavg that produces half the maximum probability of ACR 20 response (EC50) was 17 µg/ml (95% CI: 10-23 µg/ml). 
Značilna vrednost Cavg, s katero dosežemo polovico maksimalne verjetnosti odziva ACR 20 (EC50), je bila 17 µg/ml (95 % interval zaupanja: 10-23 µg/ml).
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. 
Ustrezni podatki o zdravljenju bolnikov, ki so prenašalci HBV, s protivirusnim zdravljenjem v kombinaciji z zaviralci TNF za preprečevanje reaktivacije HBV niso na voljo.
This difference in exposure is primarily due to patients on placebo being more likely to withdraw early. 
Razlika v dolžini izpostavljenosti je predvsem posledica večje verjetnosti, da bolniki, ki so prejemali placebo, predčasno zaključijo zdravljenje.
The efficacy and safety of Cimzia were evaluated versus etanercept in the CIMPACT study. 
Varnost in učinkovitost zdravila Cimzia so ocenili v primerjavi z etanerceptom v študiji CIMPACT.
• changes in cholesterol and fat levels in the blood 
• spremembe vrednosti holesterola in maščob v krvi
• You will be instructed by your doctor or healthcare giver how to inject the medicine. 
• Zdravnik ali medicinsko osebje vam bo dalo navodila, kako injicirati zdravilo.
Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics. 
Oba odmerka zdravila Cimzia sta pokazala učinkovitost v primerjavi s placebom, ne glede na starost, spol, telesno maso, indeks telesne mase, trajanje psoriaze, predhodno zdravljenje s sistemskimi zdravili in predhodno zdravljenje z biološkimi zdravili.
Medicines that bind to TNFα are also called TNF blockers. 
Zdravila, ki se vežejo na TNF-α, imenujemo tudi zaviralce TNF.
• the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. 
• zdravljenju hudega, aktivnega in progresivnega RA pri odraslih, ki se predhodno niso zdravili z MTX ali drugimi DMARDs.
• some blood parameters increased (blood alkaline phosphatase increased) 
• zvišanje nekaterih krvnih parametrov (zvišanje alkalne fosfataze v krvi)
The improvement in BASMI linear score achieved at Week 24 was maintained through Week 204 for patients who remained in the study. 
Izboljšanje BASMI linearnih rezultatov je bilo doseženo v 24. tednu in je trajalo do 204. tedna pri bolnikih, ki so ostali v študiji.
The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52. 
Primarna spremenljivka učinkovitosti je bila ocena aktivnosti bolezni ankilozirajočega spondilitisa, ki je pokazala pomemben napredek (ASDAS-MI) v 52. tednu.
Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment. 
Razpoložljivi podatki pri odraslih s psoriazo v plakih kažejo, da je klinični odziv običajno dosežen v 16 tednih zdravljenja.
1: Orange band 2: Viewing window 3: Black handle 4: Clear cap 
1: oranžni trak 2: okence 3: črni ročaj 4: prozorni pokrovček
Check the red medication level indicator is at the bottom of the cartridge - this shows you have had all of your injection. 
Preverite, da je rdeči indikator na dnu vložka - to pomeni, da ste prejeli celotno injekcijo.
• changes in blood levels of different salts 
• spremembe vrednosti različnih soli v krvi
It is important that you tell your baby's doctors and other health care professionals about your Cimzia use before the baby receives any vaccine (for more information see section on vaccinations). 
Pomembno je, da poveste vašemu otroškemu zdravniku in drugim zdravstvenim delavcem o vaši uporabi zdravila Cimzia, preden vaš dojenček prejme cepivo (za več informacij glejte poglavje o cepljenju).
• severe rash, hives or other signs of allergic reaction (urticaria) 
• hud izpuščaj, koprivnico ali druge znake alergijske reakcije (urtikarija)
The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %. 
Ocenili so, da je odstotek materinega odmerka certolizumab pegola, ki doseže dojenčka v 24-urnem obdobju, od 0,04 % do 0,30 %.
• The medication is to be used with the electromechanical injection device called “ava” which is provided separately. 
• To zdravilo je treba uporabljati z elektromehansko injekcijsko napravo, imenovano ˝ava˝, ki je na voljo ločeno.
Certolizumab pegol does not bind to the human neonatal Fc receptor (FcRn). 
Certolizumab pegol se ne veže na humani neonatalni receptor Fc (FcRn).
Patients must have been intolerant to or had an inadequate response to at least one NSAID. 
Bolniki prav tako niso prenašali ali so imeli neustrezen odziv na vsaj en NSAID.
Nevertheless, a potential risk of hypersensitivity reactions cannot be completely excluded in latex-sensitive individuals. 
Kljub temu morebitnega tveganja za preobčutljivostne reakcije pri osebah, ki so občutljive na lateks, ni mogoče popolnoma izključiti.
Moderate to severe heart failure (NYHA classes III/IV) (see section 4.4). 
Zmerno do hudo srčno popuščanje (razred NYHA III/IV) (glejte poglavje 4.4).
At Week 4 and Week 8, all infant concentrations were BLQ. 
Po 4 in 8 tednih so bile koncentracije pri vseh dojenčkih pod mejo kvantifikacije.
The mean PASI score at baseline was 20 and ranged from 12 to 69. 
Povprečni rezultat PASI ob izhodišču je bil 20 in je bil v razponu od 12 do 69.
• after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis, or 
• po 12 tednih, če imate revmatoidni artritis, aksialni spondiloartritis ali psoriatični artritis ali
• headaches (including migraines) 
• glavoboli (vključno z migrenami)
Utilization and dose adjustment of standard of care medication (SC) (e.g., NSAIDs, DMARDs, corticosteroids, analgesics) were permitted at any time. 
Uporaba in prilagoditev odmerka zdravil za standardno oskrbo (npr. zdravila NSAID, DMARD, kortikosteroidi, analgetiki) je bila dovoljena kadarkoli.
Week 52 p-values were < 0.001 for both mTSS and erosion score and ≤ 0.01 for JSN score. 
52. teden p-vrednosti so bile < 0,001 za mTSS in oceno erozije ter ≤ 0,01 za oceno JSN.
Your physician will also give you a Patient Reminder Card, which contains important safety information of which you need to be aware before you are given Cimzia and during treatment with Cimzia. 
Od zdravnika boste dobili tudi Opozorilno kartico za bolnika, ki vsebuje pomembne informacije o varnosti, s katerimi morate biti seznanjeni pred začetkom prejemanja zdravila Cimzia ter med zdravljenjem z zdravilom Cimzia.
• solid organ cancers 
• rak čvrstih organov
A total of 199 subjects (61.2% of randomized subjects) completed the study through Week 204. 
199 preiskovancev (61,2 % od naključno izbranih preiskovancev) je zaključilo študijo v 204. tednu.
Of the 850 patients, 14% had received at least one TNF-antagonist, 13% had received an anti-IL-17, and 5% had received an anti-IL 12/ 23. 
Med 850 bolniki jih je 14 % prejemalo vsaj enega antagonista TNF, 13 % jih je prejemalo proti-IL-17 in 5 % jih je prejemalo proti-IL 12/23.
It is important that you tell your baby's doctors and other health care professionals about your Cimza use so they can decide when your baby should receive any vaccine. 
Pomembno je, da poveste vašemu otroškemu zdravniku in drugim zdravstvenim delavcem o vaši uporabi zdravila Cimzia, da se bodo lahko odločili kdaj naj vaš dojenček prejme cepivo.
These response rates were based on a logistic regression model where missing data were imputed using multiple imputation (MCMC method). 
Te stopnje odziva so temeljile na modelu logistične regresije, kjer so bili manjkajoči podatki vstavljeni z multiplo imputacijo (metoda MCMC).
It is important to tell your doctor if you have had or have a serious heart condition. 
Pomembno je, da zdravniku poveste, če imate ali ste imeli resno srčno obolenje.
Micro-USB Port 
7. mikro-USB vhod
The conduct of these tests should be recorded on your Patient Reminder Card. 
Priporočljivo je, da se izvedba teh testov zabeleži tudi na bolnikovi opozorilni kartici.
The baseline PGA score ranged from moderate (70%) to severe (30%). 
Rezultat PGA ob izhodišču je bil v razponu od zmernega (70 %) do hudega (30 %).
Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the foetal compartment. 
Podatki iz ex vivo humanega zaprtega modela prenosa skozi placento kažejo na majhen ali zanemarljiv prenos v plodovni prostor.
Cimzia contains sodium acetate and sodium chloride This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ‘sodium-free'. 
Zdravilo Cimzia vsebuje natrijev acetat in natrijev klorid To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 400 mg, kar v bistvu pomeni ˝brez natrija˝.
• trouble breathing, swallowing (multiple causes for these symptoms) 
• težave z dihanjem, požiranjem (za te simptome so vzroki lahko različni)
Study RA-II Methotrexate combination (24 weeks) 
Študija RA-II Kombinacija z metotreksatom (24. teden)
The pre-filled syringe with needle guard should only be used by healthcare professionals. 
Napolnjeno brizgo z varovalom za iglo lahko uporablja samo zdravstveno osebje.
Only the highest titers were associated with reduced certolizumab pegol plasma levels, however, no impact on efficacy was observed. 
Samo najvišji titri so bili povezani z znižanimi koncentracijami certolizumab pegola v plazmi, vendar ni bilo opaženega vpliva na učinkovitost.
• Guillain-Barré syndrome* 
• Guillain-Barréjev sindrom*
There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4). 
Za povečano tveganje okužb ob daljši izpostavitvi ni dokazov (glejte poglavje 4.4).
Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of 148 weeks overall. 
Od teh jih je 427 zaključilo 2-letno odprto sledilno študijo in bilo celotno izpostavljeno zdravilu Cimzia 148 tednov.
If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued (see section 4.3). 
Če je pred ali med zdravljenjem diagnosticirana aktivna tuberkuloza, se zdravljenja z zdravilom Cimzia ne sme vpeljati in ga je treba prekiniti (glejte poglavje 4.3).