FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean baseline BSA was 25% and ranged from 10% to 96%.
Slovenian: Povprečni BSA ob izhodišču je bil 25 % in je bil v razponu od 10 % do 96 %.
English: This is so that the doctor can determine if Cimzia is working for you or if another treatment needs to be considered.
Slovenian: Namen tega je, da zdravnik ugotovi, ali zdravilo Cimzia pri vas učinkuje ali pa je treba razmisliti o drugem zdravljenju.
English: Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
Slovenian: p-vrednosti po Waldu so navedene za primerjavo zdravil ob uporabi logistične regresije s faktorji za zdravljenje in regijo.
English: The maximum duration of the study was 216 weeks.
Slovenian: Najdaljše trajanje študije je bilo 216 tednov.
English: This number decreases with increasing doses of concomitant MTX treatment.
Slovenian: To število se zmanjšuje s povečanjem odmerkov sočasno apliciranega MTX.
English: • sepsis (serious infection which can result in organ failure, shock or death)
Slovenian: • sepsa (huda okužba, ki ima lahko za posledico odpoved organov, šok ali smrt)
English: This injection should not be mixed in the same syringe with any other medicine.
Slovenian: Tega zdravila ne smete mešati v isti injekcijski brizgi z drugimi zdravili.
English: Interference with thrombin time (TT) and prothrombin time (PT) assays have not been observed.
Slovenian: Interference s testi določanja trombinskega časa (TT) in protrombinskega časa (PT) niso opazili.
English: - Once the needle cap has been removed, you must give the injection within 5 minutes.
Slovenian: - Ko je pokrovček igle odstranjen, morate injicirati v roku 5 minut.
English: See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.
Slovenian: Glejte tudi poglavje 6.4 glede roka uporabnosti za shranjevanje pri sobni temperaturi do 25 °C.
English: • Place the orange skin sensor against the injection site where you are going to inject.
Slovenian: • Namestite oranžni senzor kože na mesto injiciranja, kjer nameravate injicirati.
English: If the viewing window turns orange and you hear a second click this means the injection has been completed.
Slovenian: Če se okence obarva oranžno in slišite drugi ˝klik˝, to pomeni, da je bilo injiciranje končano.
English: • Merkel cell carcinoma (a type of skin cancer)*
Slovenian: • karcinom Merklovih celic (vrsta kožnega raka)*
English: - 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.
Slovenian: - Izberete lahko ˝najpočasneje˝, ˝počasi˝, ˝hitro˝ali ˝najhitreje˝ - s tem je nadzorovana hitrost injiciranja zdravila in izberete jo (prilagodite), kakor vam najbolj ustreza.
English: If you take Cimzia, your risk of getting lymphoma or other cancers may increase.
Slovenian: Če jemljete zdravilo Cimzia, se lahko tveganje za nastanek limfoma ali drugih vrst raka poveča.
English: 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.
Slovenian: 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.
English: Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex.
Slovenian: Stik z naravnim lateksom lahko pri osebah, občutljivih na lateks, povzroči resne alergijske reakcije.
English: - If you have a nervous system disorder, such as multiple sclerosis, your doctor will decide whether you should use Cimzia.
Slovenian: - Če imate bolezni živčevja, kot je multipla skleroza, se bo vaš zdravnik odločil, ali lahko uporabljate zdravilo Cimzia.
English: • Release the skin with the first hand.
Slovenian: • S prvo roko sprostite kožo.
English: As clearance decreases with decreasing body weight, females may generally obtain somewhat higher systemic exposure of certolizumab pegol.
Slovenian: Ker se pri manjši telesni teži zmanjša tudi očistek, je lahko pri ženskah na splošno sistemska izpostavljenost certolizumab pegolu do določene mere večja.
English: • fungal infections (occur when the ability to fight off infection is lessened)
Slovenian: • glivične okužbe (pojavijo se, kadar je sposobnost organizma za obrambo pred okužbami zmanjšana)
English: Cimzia will be given to you by your doctor or nurse, in hospital or clinic.
Slovenian: Zdravilo Cimzia vam bo dal vaš zdravnik ali medicinska sestra v bolnišnici ali ambulanti.
English: • muscle problems including increased muscle enzymes
Slovenian: • mišična obolenja, vključno s povečanimi vrednostmi mišičnih encimov
English: PASI75 and PGA at Week 16 were key secondary endpoints.
Slovenian: PASI 75 in PGA v 16. tednu sta bila ključna sekundarna opazovana dogodka.
English: The results of clinical trials RA-I and RA-II are shown in Table 3.
Slovenian: Rezultati kliničnih študij RA-I in RA-II so prikazani v preglednici 3.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 01 oktober 2009 Datum zadnjega podaljšanja: 16 maj 2014
English: Patients had ≥ 3 swollen and tender joints and increased acute phase reactants.
Slovenian: Bolniki so imeli ≥ 3 otekle in boleče sklepe ter zvišane reaktante akutne faze.
English: • increased iron levels in the body
Slovenian: • zvišana vrednost železa v telesu
English: Table 4: C-EARLY trial: percent of patients in sustained remission and sustained low disease activity at Week 52
Slovenian: Preglednica 4 Preskušanje C-EARLY: Delež bolnikov s trajnejšo remisijo in trajnejšo manjšo aktivnostjo bolezni v 52. tednu
English: Table 2 Clinical trial description Study number
Slovenian: Preglednica 2 Opis klinične študije Številka študije
English: 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).
Slovenian: 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)
English: • tuberculosis infection
Slovenian: • okužba s tuberkulozo
English: 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.
Slovenian: 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.
English: Cimzia is used to reduce skin inflammation and other signs and symptoms of your disease.
Slovenian: Zdravilo Cimzia se uporablja za zmanjšanje kožnega vnetja ter drugih znakov in simptomov bolezni.
English: About 22% (54/248) of the patients who were anti-certolizumab pegol antibody positive at any time, had antibodies that were classified as neutralizing.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: ASAS 40 Week 12
Slovenian: ASAS 40 12. teden
English: Hold the pre-filled pen straight (at a 90° degree angle) against the skin, that previously has been cleaned (the “injection site”).
Slovenian: Držite napolnjeni injekcijski peresnik h koži (pod kotom 90 stopinj), ki je bila predhodno očiščena (mesto injiciranja).
English: Missing data were imputed using multiple imputation based on the MCMC method.
Slovenian: Manjkajoči podatki so bili vstavljeni z multiplo imputacijo na podlagi metode MCMC.
English: - Press the
Slovenian: - Pritisnite
English: When assessed using the previous ELISA method, the presence of antibodies to certolizumab pegol resulted in an approximately three-fold increase in clearance.
Slovenian: Pri ocenjevanju s prej omenjeno metodo ELISA prisotnost protiteles proti certolizumab pegolu vodi do približno trikratnega povečanja očistka.
English: 47% had received prior phototherapy or chemophototherapy, and 30% had received prior biologic therapy for the treatment of psoriasis.
Slovenian: 47 % jih je predhodno prejemalo fototerapijo ali kemofototerapijo in 30 % je predhodno prejemalo biološka zdravila za zdravljenje psoriaze.
English: • formation of stones in the gall bladder
Slovenian: • nastanek kamnov v žolčniku
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage.
Slovenian: Ovrednotenje obravnavanja znakov in simptomov ter zaviranja strukturnih poškodb.
English: Subject who escaped or withdrew (based on not achieving PASI 50 response) were treated as non-responders at Week 48.
Slovenian: 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.
English: • Do not use the medication if it has been dropped after taking it out of the pack.
Slovenian: • Zdravila ne uporabljajte, če vam je padlo, potem ko ste ga vzeli iz pakiranja.
English: Caution should be exercised when treating the elderly patients, and particular attention paid with respect to occurrence of infections.
Slovenian: Pri zdravljenju starejših bolnikov je potrebna posebna pozornost, zlasti glede pojava okužb.
English: The injection begins when a first “click” is heard and the orange band at the bottom of the pre-filled pen disappears.
Slovenian: Injiciranje se začne, ko zaslišite prvi ˝klik˝ in oranžni trak na dnu napolnjenega injekcijskega peresnika izgine.
English: 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.
Slovenian: Če imate KOPB ali ste hud kadilec, se posvetujte z zdravnikom o tem, če je zdravljenje z zaviralcem TNF za vas primerno.
English: • general physical health deterioration.
Slovenian: • poslabšanje splošnega zdravstvenega stanja
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Slovenian: Drugi primeri vključujejo množico različnih malignih obolenj in redka maligna obolenja, ki jih običajno povezujejo z imunosupresijo.
English: • Remove the Cimzia pack from the refrigerator.
Slovenian: • Vzemite pakiranje zdravila Cimzia iz hladilnika.
English: Table 9: ASDAS-MI and ASAS 40 responses in AS0006 (percent of patients)
Slovenian: Preglednica 9 Odzivi ASDAS-MI in ASAS 40 v AS0006 (odstotek bolnikov) Parametri
English: Table 3 ACR response in clinical trials RA-I and RA-II Study RA-I Methotrexate combination (24 and 52 weeks)
Slovenian: Preglednica 3 Odziv ACR v kliničnih študijah RA-I in RA-II Študija RA-I Kombinacija z metotreksatom (24. in 52. teden)
English: Then, talk to your doctor and inject the following doses as instructed.
Slovenian: Nato se z zdravnikom posvetujte in si po navodilih injicirajte naslednje odmerke.
English: Check the medicine in the body of the syringe.
Slovenian: Preverite zdravilo v telesu injekcijske brizge.
English: • When the injection is complete, a message is shown on ava's screen saying "Injection complete.
Slovenian: • Ko je injiciranje zaključeno, se na ava zaslonu prikaže sporočilo ˝Injection complete.
English: Because the elimination of certolizumab pegol may take up to 5 months, monitoring should be continued throughout this period (see section 4.3).
Slovenian: Ker se certolizumab pegol iz telesa lahko izloča do 5 mesecev, je potrebno bolnika ves ta čas pozorno spremljati (glejte poglavje 4.3).
English: If you experience these symptoms, contact your doctor.
Slovenian: Če se ti simptomi pojavijo, se posvetujte s svojim zdravnikom.
English: The typical Cavg that produces half the maximum probability of ACR 20 response (EC50) was 17 µg/ml (95% CI: 10-23 µg/ml).
Slovenian: 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).
English: 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.
Slovenian: Ustrezni podatki o zdravljenju bolnikov, ki so prenašalci HBV, s protivirusnim zdravljenjem v kombinaciji z zaviralci TNF za preprečevanje reaktivacije HBV niso na voljo.
English: This difference in exposure is primarily due to patients on placebo being more likely to withdraw early.
Slovenian: Razlika v dolžini izpostavljenosti je predvsem posledica večje verjetnosti, da bolniki, ki so prejemali placebo, predčasno zaključijo zdravljenje.
English: The efficacy and safety of Cimzia were evaluated versus etanercept in the CIMPACT study.
Slovenian: Varnost in učinkovitost zdravila Cimzia so ocenili v primerjavi z etanerceptom v študiji CIMPACT.
English: • changes in cholesterol and fat levels in the blood
Slovenian: • spremembe vrednosti holesterola in maščob v krvi
English: • You will be instructed by your doctor or healthcare giver how to inject the medicine.
Slovenian: • Zdravnik ali medicinsko osebje vam bo dalo navodila, kako injicirati zdravilo.
English: 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.
Slovenian: 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.
English: Medicines that bind to TNFα are also called TNF blockers.
Slovenian: Zdravila, ki se vežejo na TNF-α, imenujemo tudi zaviralce TNF.
English: • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Slovenian: • zdravljenju hudega, aktivnega in progresivnega RA pri odraslih, ki se predhodno niso zdravili z MTX ali drugimi DMARDs.
English: • some blood parameters increased (blood alkaline phosphatase increased)
Slovenian: • zvišanje nekaterih krvnih parametrov (zvišanje alkalne fosfataze v krvi)
English: The improvement in BASMI linear score achieved at Week 24 was maintained through Week 204 for patients who remained in the study.
Slovenian: Izboljšanje BASMI linearnih rezultatov je bilo doseženo v 24. tednu in je trajalo do 204. tedna pri bolnikih, ki so ostali v študiji.
English: The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52.
Slovenian: Primarna spremenljivka učinkovitosti je bila ocena aktivnosti bolezni ankilozirajočega spondilitisa, ki je pokazala pomemben napredek (ASDAS-MI) v 52. tednu.
English: Available data in adults with plaque psoriasis suggest that a clinical response is usually achieved within 16 weeks of treatment.
Slovenian: Razpoložljivi podatki pri odraslih s psoriazo v plakih kažejo, da je klinični odziv običajno dosežen v 16 tednih zdravljenja.
English: 1: Orange band 2: Viewing window 3: Black handle 4: Clear cap
Slovenian: 1: oranžni trak 2: okence 3: črni ročaj 4: prozorni pokrovček
English: Check the red medication level indicator is at the bottom of the cartridge - this shows you have had all of your injection.
Slovenian: Preverite, da je rdeči indikator na dnu vložka - to pomeni, da ste prejeli celotno injekcijo.
English: • changes in blood levels of different salts
Slovenian: • spremembe vrednosti različnih soli v krvi
English: 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).
Slovenian: 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).
English: • severe rash, hives or other signs of allergic reaction (urticaria)
Slovenian: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije (urtikarija)
English: The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %.
Slovenian: Ocenili so, da je odstotek materinega odmerka certolizumab pegola, ki doseže dojenčka v 24-urnem obdobju, od 0,04 % do 0,30 %.
English: • The medication is to be used with the electromechanical injection device called “ava” which is provided separately.
Slovenian: • To zdravilo je treba uporabljati z elektromehansko injekcijsko napravo, imenovano ˝ava˝, ki je na voljo ločeno.
English: Certolizumab pegol does not bind to the human neonatal Fc receptor (FcRn).
Slovenian: Certolizumab pegol se ne veže na humani neonatalni receptor Fc (FcRn).
English: Patients must have been intolerant to or had an inadequate response to at least one NSAID.
Slovenian: Bolniki prav tako niso prenašali ali so imeli neustrezen odziv na vsaj en NSAID.
English: Nevertheless, a potential risk of hypersensitivity reactions cannot be completely excluded in latex-sensitive individuals.
Slovenian: Kljub temu morebitnega tveganja za preobčutljivostne reakcije pri osebah, ki so občutljive na lateks, ni mogoče popolnoma izključiti.
English: Moderate to severe heart failure (NYHA classes III/IV) (see section 4.4).
Slovenian: Zmerno do hudo srčno popuščanje (razred NYHA III/IV) (glejte poglavje 4.4).
English: At Week 4 and Week 8, all infant concentrations were BLQ.
Slovenian: Po 4 in 8 tednih so bile koncentracije pri vseh dojenčkih pod mejo kvantifikacije.
English: The mean PASI score at baseline was 20 and ranged from 12 to 69.
Slovenian: Povprečni rezultat PASI ob izhodišču je bil 20 in je bil v razponu od 12 do 69.
English: • after 12 weeks if you have rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis, or
Slovenian: • po 12 tednih, če imate revmatoidni artritis, aksialni spondiloartritis ali psoriatični artritis ali
English: • headaches (including migraines)
Slovenian: • glavoboli (vključno z migrenami)
English: Utilization and dose adjustment of standard of care medication (SC) (e.g., NSAIDs, DMARDs, corticosteroids, analgesics) were permitted at any time.
Slovenian: Uporaba in prilagoditev odmerka zdravil za standardno oskrbo (npr. zdravila NSAID, DMARD, kortikosteroidi, analgetiki) je bila dovoljena kadarkoli.
English: Week 52 p-values were < 0.001 for both mTSS and erosion score and ≤ 0.01 for JSN score.
Slovenian: 52. teden p-vrednosti so bile < 0,001 za mTSS in oceno erozije ter ≤ 0,01 za oceno JSN.
English: 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.
Slovenian: 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.
English: • solid organ cancers
Slovenian: • rak čvrstih organov
English: A total of 199 subjects (61.2% of randomized subjects) completed the study through Week 204.
Slovenian: 199 preiskovancev (61,2 % od naključno izbranih preiskovancev) je zaključilo študijo v 204. tednu.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: These response rates were based on a logistic regression model where missing data were imputed using multiple imputation (MCMC method).
Slovenian: Te stopnje odziva so temeljile na modelu logistične regresije, kjer so bili manjkajoči podatki vstavljeni z multiplo imputacijo (metoda MCMC).
English: It is important to tell your doctor if you have had or have a serious heart condition.
Slovenian: Pomembno je, da zdravniku poveste, če imate ali ste imeli resno srčno obolenje.
English: Micro-USB Port
Slovenian: 7. mikro-USB vhod
English: The conduct of these tests should be recorded on your Patient Reminder Card.
Slovenian: Priporočljivo je, da se izvedba teh testov zabeleži tudi na bolnikovi opozorilni kartici.
English: The baseline PGA score ranged from moderate (70%) to severe (30%).
Slovenian: Rezultat PGA ob izhodišču je bil v razponu od zmernega (70 %) do hudega (30 %).
English: Data from a human closed-circuit placental transfer model ex vivo suggest low or negligible transfer to the foetal compartment.
Slovenian: Podatki iz ex vivo humanega zaprtega modela prenosa skozi placento kažejo na majhen ali zanemarljiv prenos v plodovni prostor.
English: 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'.
Slovenian: 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˝.
English: • trouble breathing, swallowing (multiple causes for these symptoms)
Slovenian: • težave z dihanjem, požiranjem (za te simptome so vzroki lahko različni)
English: Study RA-II Methotrexate combination (24 weeks)
Slovenian: Študija RA-II Kombinacija z metotreksatom (24. teden)
English: The pre-filled syringe with needle guard should only be used by healthcare professionals.
Slovenian: Napolnjeno brizgo z varovalom za iglo lahko uporablja samo zdravstveno osebje.
English: Only the highest titers were associated with reduced certolizumab pegol plasma levels, however, no impact on efficacy was observed.
Slovenian: Samo najvišji titri so bili povezani z znižanimi koncentracijami certolizumab pegola v plazmi, vendar ni bilo opaženega vpliva na učinkovitost.
English: • Guillain-Barré syndrome*
Slovenian: • Guillain-Barréjev sindrom*
English: There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4).
Slovenian: Za povečano tveganje okužb ob daljši izpostavitvi ni dokazov (glejte poglavje 4.4).
English: Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of 148 weeks overall.
Slovenian: Od teh jih je 427 zaključilo 2-letno odprto sledilno študijo in bilo celotno izpostavljeno zdravilu Cimzia 148 tednov.
English: If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued (see section 4.3).
Slovenian: 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).
English: During the 14-week follow-up, no treatment effects of certolizumab pegol were seen on semen quality parameters compared to placebo.
Slovenian: Med 14-dnevnim spremljanjem ni bilo opaziti učinkov zdravljenja z certolizumab pegolom na parametre kakovosti sperme v primerjavi s placebom.