FrancophonIA/ELRC3.0 huggingface dataset:
English: - If ava is accidentally removed from your skin during the injection, the injection will automatically stop and the needle will go back into ava.
Slovenian: - Če med injiciranje pomotoma umaknete napravo ava s kože, se bo injiciranje avtomatsko prekinilo in igla bo šla nazaj v napravo ava.
English: • When the syringe is empty, carefully remove the needle from the skin at the same angle at which it was inserted.
Slovenian: • Ko je brizga prazna, previdno odstranite iglo iz kože pod enakim kotom, kot ste jo vanjo potisnili.
English: • The needle will automatically move back into the empty pen.
Slovenian: • Injekcijska igla se bo avtomatično pomaknila nazaj v prazen peresnik.
English: If the indicator is not at the bottom, contact your pharmacist.
Slovenian: Če na dnu ni indikatorja, se posvetujte s farmacevtom.
English: For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate (see section 5.2), but the need for treatment of the woman should also be taken into account (see below).
Slovenian: Zaradi hitrosti izločanja zdravila je treba pri ženskah, ki načrtujejo nosečnost, razmisliti o neprekinjeni kontracepciji še 5 mesecev po zadnjem odmerku zdravila Cimzia (glejte poglavje 5.2), vendar je treba upoštevati tudi potrebo po zdravljenju ženske (glejte spodaj).
English: • Gently grasp the cleaned area of skin with one hand and hold firmly.
Slovenian: • Z eno roko nežno primite očiščeni predel kože in ga čvrsto držite.
English: • increase of red cell mass
Slovenian: • povečanje mase rdečih krvničk
English: Check the medicine through the viewing window.
Slovenian: Preverite zdravilo skozi okence.
English: Key efficacy outcomes
Slovenian: Ključni rezultati glede učinkovitosti
English: Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine concomitantly with a TNF-antagonist at or prior to diagnosis.
Slovenian: Skoraj vsi od teh bolnikov so bili sočasno zdravljeni z imunosupresivi azatioprinom in /ali 6-merkaptopurinom ter zaviralci TNF ob postavljeni diagnozi ali pred diagnozo.
English: **These events have been related to the class of TNF-antagonists.
Slovenian: **Te dogodke povezujejo s skupino zaviralcev TNF.
English: Among patients remaining in the study, improvements in all afore-mentioned key efficacy outcomes were maintained through Week 204 in the overall population as well as in the subpopulations.
Slovenian: Med bolniki, ki so ostali v študiji, je izboljšanje v vseh prej omenjenih ključnih rezultatih učinkovitosti trajalo do 204. tedna, tako pri celotni populaciji kot tudi v podpopulacijah.
English: In addition, experiments of FcRn-mediated transcytosis in cells transfected with human FcRn showed negligible transfer (see section 4.6).
Slovenian: Poleg tega so poskusi s transcitozo, ki jo uravnava FcRn, pri celicah, pri katerih so izvedli transfekcijo s humanim FcRn, pokazali zanemarljiv prenos (glejte poglavje 4.6).
English: In the clinical trials, there was an apparently higher incidence of infections among subjects ≥ 65 years of age, compared to younger subjects, although experience is limited.
Slovenian: V kliničnih študijah je bila pri bolnikih, starih ≥ 65 let, pogostost okužb v primerjavi z mlajšimi bolniki precej večja, čeprav so izkušnje omejene.
English: Active tuberculosis or other severe infections such as sepsis or opportunistic infections (see section 4.4).
Slovenian: Aktivna tuberkuloza ali druge hude okužbe, kot so sepsa ali oportunistične okužbe (glejte poglavje
English: • suicide attempt, mental impairment, delirium
Slovenian: • poskusi samomora, duševne motnje, delirij
English: In cases of overdose, it is recommended that patients are monitored closely for any adverse reactions or effect, and appropriate symptomatic treatment initiated immediately.
Slovenian: V primerih prevelikega odmerjanja je bolnike priporočljivo pozorno spremljati zaradi možnosti pojava neželenih reakcij ali učinkov ter takoj uvesti simptomatsko zdravljenje.
English: The data above reflect the percentage of patients whose test results were considered positive for antibodies to Cimzia in an ELISA, and are highly dependent on the sensitivity and specificity of the assay.
Slovenian: Zgoraj navedeni podatki kažejo odstotek bolnikov, pri katerih so bili rezultati testa ELISA na protitelesa proti zdravilu Cimzia pozitivni, in so v veliki meri odvisni od občutljivosti in specifičnosti testa.
English: This was also the case for the other parameters of peripheral activity (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis).
Slovenian: Tako je bilo tudi z ostalimi parametri periferne aktivnosti (npr. število oteklih sklepov, število bolečih/občutljivih sklepov, daktilitis in entezitis).
English: However, if any of the following steps go wrong and/or if you feel unsure about the injection process, contact your doctor or pharmacist.
Slovenian: Vendar, če gre karkoli narobe pri sledečih korakih in/ali če ste negotovi pri postopku injiciranja, se posvetujte z zdravnikom ali farmacevtom.
English: Cimzia is used in adults for the following inflammatory diseases:
Slovenian: Zdravilo Cimzia se uporablja pri odraslih za naslednje vnetne bolezni:
English: Cimzia may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Cimzia ima lahko manjši vpliv na sposobnost vožnje in upravljanja s stroji.
English: • Press the (Start/Pause button).
Slovenian: • Pritisnite (start/pavza gumb).
English: • Push plunger head all the way down until the entire dose has been given and the plunger head is between the needle guard activation clips.
Slovenian: • Glavo bata potisnite do konca, dokler ni apliciran celotni odmerek in je glava bata med aktivacijskima nastavkoma varovala za iglo.
English: If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis you will first be given other medicines.
Slovenian: Če imate ankilozirajoči spondilitis ali neradiografski aksialni spondiloartritis boste najprej dobili druga zdravila.
English: Assessments on remission (DAS28(ESR) <2.6), Low Disease Activity (DAS28(ESR) ≤3.2) status, ACR50 and ACR 70 by visit demonstrated that Cimzia+MTX treatment led to faster and greater responses than PBO+MTX treatment.
Slovenian: Ocena remisije (DAS28(ESR) < 2,6), manjše aktivnosti bolezni (DAS28(ESR) ≤ 3,2), ACR50 in ACR70 ob obisku je pokazala, da je zdravljenje z zdravilom Cimzia in MTX vodilo do hitrejšega in večjega odziva kot zdravljenje s PBO in MTX.
English: Before initiation of therapy with Cimzia, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Cimzia je treba pri vseh bolnikih oceniti prisotnost aktivne ali neaktivne (latentne) tuberkulozne okužbe.
English: Plaque psoriasis is an inflammatory disease of the skin, and can also affect your scalp and nails.
Slovenian: Psoriaza v plakih je vnetna bolezen kože, ki lahko prizadene tudi lasišče in nohte.
English: • blood clots in the veins or lungs
Slovenian: • krvni strdki v venah ali pljučih
English: Other medicines and Cimzia
Slovenian: Druga zdravila in zdravilo Cimzia
English: The ava injection device currently does not support administration of a maintenance dose of 400 mg every 2 weeks; for plaque psoriasis patients receiving this maintenance dose, the physician is adviced to use other presentations.
Slovenian: Z napravo za injiciranje ava trenutno ni možno dajati vzdrževalnega odmerka 400 mg vsaka 2 tedna; za bolnike s psoriazo v plakih, ki prejemajo ta vzdrževalni odmerek, se zdravniku svetuje, da uporabi druge oblike pakiranja.
English: It is usually injected into the thigh or tummy.
Slovenian: Običajno se injicira v stegno ali trebuh.
English: Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region) (see section 5.3).
Slovenian: Neklinične študije kažejo na nizko ali zanemarljivo stopnjo prenosa homolognega Fab fragmenta certolizumab pegola skozi placento (brez Fc regije) (glejte poglavje 5.3).
English: DoseFlex clinical trial
Slovenian: DoseFlex klinično preskušanje
English: This will help to reduce discomfort when injecting.
Slovenian: To bo zmanjšalo neprijeten občutek ob injiciranju.
English: Please follow these carefully.
Slovenian: Natančno sledite tem navodilom.
English: Non-responder imputation was used for missing data.
Slovenian: Za neodzivne osebe so bili manjkajoči podatki vstavljeni.
English: • blood and lymphatic system cancers like lymphoma and leukaemia
Slovenian: • rak krvi in limfatičnega sistema, kot sta limfom in levkemija
English: Appropriate screening tests, e.g. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba izvesti ustrezne presejalne teste, npr. tuberkulinski kožni test in rentgensko slikanje prsnega koša (v skladu z lokalnimi priporočili).
English: For patients remaining in the study, improvements in all afore-mentioned outcomes were largely maintained through Week 204.
Slovenian: Za bolnike, ki so ostali v študiji, je izboljšanje v vseh prej omenjenih rezultatih trajalo v veliki meri do 204. tedna.
English: Choosing and preparing an injection site • Choose a site on your thigh or tummy.
Slovenian: Izbira in priprava mesta za injiciranje • Izberite mesto na stegnu ali trebuhu.
English: Multiple doses of up to 800 mg subcutaneously and 20 mg/kg intravenously have been administered.
Slovenian: Bolniki so prejemali ponavljajoče se odmerke do 800 mg subkutano in 20 mg/kg intravensko.
English: Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.
Slovenian: Zato je zgodnje odkrivanje vsake okužbe, zlasti v primeru neznačilne klinične slike bolezni, za pravočasno diagnosticiranje in uvedbo zdravljenja bistvenega pomena.
English: - Use a clean dry cloth to wipe off any condensation on the outside of the cartridge.
Slovenian: - Uporabite čisto, suho krpo, da obrišete kondenz z zunanje strani vložka.
English: Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:
Slovenian: Svojega zdravnika obvestite ČIMPREJ, če ste opazili katerega od naslednjih neželenih učinkov:
English: The Fab' fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Slovenian: Fragment protitelesa Fab' vsebuje beljakovinske spojine in naj bi se s pomočjo proteolize razgradil do peptidov in aminokislin.
English: Distribution studies have demonstrated that placental and milk transfer of cTN3 PF to the foetal and neonatal circulation is negligible.
Slovenian: Študije porazdelitve so pokazale, da je prehod cTN3 PF prek placente in mleka v fetalni in neonatalni krvni obtok zanemarljiv.
English: If you received Cimzia while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Slovenian: Če ste prejeli zdravilo Cimzia med nosečnostjo, je lahko vaš dojenček izpostavljen večjemu tveganju za okužbo vse do 5 mesecev od vašega zadnjega odmerka, ki ste ga prejeli med nosečnostjo.
English: Patients also had active psoriatic skin lesions or a documented history of psoriasis and had failed 1 or more DMARDs.
Slovenian: Bolniki so imeli tudi aktivne psoriatične lezije na koži ali dokumentirano psoriazo v anamnezi in se niso odzvali na zdravljenje z 1 ali več DMARD.
English: If you have questions, please ask your doctor.
Slovenian: Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
English: The mTSS Score was modified for psoriatic arthritis by addition of hand distal interphalangeal joints.
Slovenian: Ocena mTSS je bila spremenjena za psoriatični artritis z dodatkom distalnih interfalangealnih sklepov rok.
English: C-EARLY (to 52 wee ks)
Slovenian: C-EARLY (do 52 tednov)
English: Rare gastrointestinal tumours, melanoma
Slovenian: redki gastrointestinalni tumorji, melanom
English: In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to receive a single subcutaneous dose of 400 mg of certolizumab pegol or placebo.
Slovenian: V kliničnem preskušanju, v katerem so ocenjevali učinek certolizumab pegola na parametre kakovosti sperme, je 20 zdravih moških naključno prejelo enkratni subkutani odmerek 400 mg certolizumab pegola ali placebo.
English: - Keep the needle cap - you will need it to remove the used medication from ava later.
Slovenian: - Obdržite pokrovček igle - potrebovali ga boste kasneje za odstranitev uporabljenega vložka iz naprave ava.
English: Creatine phosphokinase elevations
Slovenian: Zvišane vrednosti kreatin-fosfokinaze
English: • lung inflammation (interstitial lung disease, pneumonitis)
Slovenian: • vnetje pljuč (intersticijska pljučna bolezen, pnevmonitis)
English: * p<0.001 All percents reflect the proportion of patients who responded in the full analysis set.
Slovenian: Vsi odstotki odražajo delež bolnikov, ki so se odzvali na kompletno analizo.
English: Improvements in all afore-mentioned outcomes were maintained through Week 216.
Slovenian: Izboljšanje v vseh prej omenjenih izidih je trajalo do 216. tedna.
English: • bacterial infections in any site (a collection of pus)
Slovenian: • bakterijske okužbe na različnih mestih (nabiranje gnoja)
English: After patients receive Cimzia, careful attention should be given to interpretation of abnormal coagulation results.
Slovenian: Ko bolniki prejmejo zdravilo Cimzia, je treba posebno pozornost posvetiti interpretaciji nenormalnih vrednosti koagulacijskih testov.
English: Despite previous or concomitant prophylactic treatment for tuberculosis, cases of active tuberculosis have occurred in patients treated with TNF-antagonists including Cimzia.
Slovenian: Kljub predhodnemu ali sočasnemu profilaktičnemu zdravljenju tuberkuloze, so se pri bolnikih, ki so se zdravili z zaviralci TNF, vključno z zdravilom Cimzia, pojavili primeri aktivne tuberkuloze.
English: The infections consisted primarily of upper respiratory tract infections and viral infections (including herpes infections).
Slovenian: Okužbe so bile pretežno okužbe zgornjih dihal in virusne okužbe (vključno z okužbami s herpesom).
English: A dose of 400 mg every 2 weeks can be considered in patients with insufficient response (see section 5.1).
Slovenian: Pri bolnikih z nezadostnim odzivom se lahko razmisli o odmerku 400 mg vsaka 2 tedna (glejte poglavje 5.1).
English: Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection.
Slovenian: Po subkutani aplikaciji doseže certolizumab pegol največje plazemske koncentracije med 54 in 171 urami po injiciranju.
English: Patients had a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area (BSA) involvement of ≥ 10%, Physician Global Assessment (PGA) of ≥ 3, and were candidates for systemic therapy and/or phototherapy and/or chemophototherapy.
Slovenian: Bolniki so imeli rezultat indeksa površine in izrazitosti psoriaze (PASI-Psoriasis Area and Severity Index) ≥ 12, vpletenost telesne površine (BSA-body surface area ) ≥ 10 %, zdravnikovo splošno oceno (PGAPhysician Global Assessment) ≥ 3, in so bili kandidati za sistemsko zdravljenje in/ali fototerapijo in/ali kemofototerapijo.
English: Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months.
Slovenian: Zdravilo Cimzia so preučili pri 1112 bolnikih s psoriazo v nadzorovanih in odprtih študijah, ki so trajale do 18 mesecev.
English: What Cimzia is and what it is used for
Slovenian: Kaj je zdravilo Cimzia in za kaj ga uporabljamo
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including certolizumab pegol, who are chronic carriers of this virus (i.e., surface antigen positive).
Slovenian: Reaktivacija hepatitisa B se je pojavila pri bolnikih, ki so prejemali zaviralce TNF, vključno s certolizumab pegolom, in so kronični prenašalci virusa (t.j., pozitiven površinski antigen).
English: • slow down the damage to the cartilage and bone of the joints caused by the disease,
Slovenian: • upočasnitev poškodbe hrustanca in kosti sklepov, ki jih povzroča bolezen,
English: Some of these reactions occurred after the first administration of Cimzia.
Slovenian: Nekaj teh reakcij se je pojavilo po prvi uporabi zdravila Cimzia.
English: For these reasons, comparison of the incidence of antibodies to Cimzia with the incidence of antibodies to other TNF-antagonists is not appropriate.
Slovenian: Iz teh razlogov primerjava incidence protiteles proti zdravilu Cimzia in incidence protiteles proti drugim zaviralcem TNF ni primerna.
English: Cimzia vs. placebo: *p≤0.01, ** p<0.001 a. Major clinical response is defined as achieving ACR 70 response at every assessment over a continuous 6-month period
Slovenian: Cimzia v primerjavi s placebom: *p≤0,01, ** p<0,001 a. Klinično pomemben odziv definiramo kot doseganje odziva ACR 70 ob vsakem ocenjevanju v neprekinjenem obdobju 6 mesecev.
English: Therefore the use of certolizumab pegol in combination with anakinra or abatacept is not recommended (see section 4.5).
Slovenian: Zato uporaba certolizumab pegola v kombinaciji z anakinro ali abataceptom ni priporočljiva (glejte poglavje 4.5).
English: If you have active psoriatic arthritis you will first be given other medicines, usually methotrexate.
Slovenian: Če imate aktivni psoriatični artritis, boste najprej dobili druga zdravila, običajno metotreksat.
English: For women planning pregnancy, contraception may be considered for 5 months after the last Cimzia dose.
Slovenian: Pri ženskah, ki načrtujejo nosečnost, je treba razmisliti o uporabi kontracepcije še 5 mesecev po zadnjem odmerku zdravila Cimzia.
English: • Let go of the needle cap - this allows ava to check if the medication is usable.
Slovenian: • Spustite pokrovček igle - to omogoča napravi ava, da preveri, če je vložek uporaben.
English: • Do not shake the medication.
Slovenian: • Zdravila ne stresajte.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Cimzia.
Slovenian: Pri nekaterih bolnikih, pri katerih je bilo uspešno zdravljenje aktivne tuberkuloze, se je med zdravljenjem z zdravilom Cimzia ponovno razvila tuberkuloza.
English: In a clinical trial with another TNF-antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Slovenian: V klinični študiji z drugim zaviralcem TNF so opazili poslabšanje kongestivnega srčnega popuščanja in povečano smrtnost zaradi kongestivnega srčnega popuščanja.
English: INFORMATION IN BRAILLE Cimzia 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Cimzia 200 mg
English: Cimzia binds to a specific protein called tumour necrosis factor α (TNFα).
Slovenian: Cimzia se veže na posebno beljakovino, ki se imenuje tumorje nekrotizirajoči faktor alfa (TNF-α).
English: When Cimzia has been used to treat other diseases the following uncommon side effects have occurred:
Slovenian: Pri uporabi zdravila Cimzia za zdravljenje drugih bolezni so se občasno pojavili naslednji neželeni učinki:
English: • fistula (tract from one organ to another) (any site)
Slovenian: • fistula (povezava med organi) (kjerkoli)
English: The safety and efficacy of Cimzia in children and adolescents below age 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Cimzia pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: In male rats, reduced sperm motility and a trend of reduced sperm count were observed.
Slovenian: Pri podganjih samcih so opazili zmanjšanje gibljivosti spermijev in trend upadanja števila spermijev.
English: Some of these reactions could occur after the first administration of Cimzia.
Slovenian: Nekaj teh reakcij se lahko pojavi po prvi uporabi zdravila Cimzia.
English: PASI 75 (c) Week 12 Week 24 Week 48
Slovenian: PASI 75 (c) 12. teden 24. teden 48. teden
English: If you received Cimzia during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: Če ste prejeli zdravilo Cimzia med nosečnostjo, je vaš dojenček lahko izpostavljen večjemu tveganju za okužbo.
English: The frequency of creatine phosphokinase (CPK) elevations was generally higher in patients with axSpA as compared to the RA population.
Slovenian: Pogostnost zvišanih vrednosti kreatin-fosfokinaze (CPK) je na splošno večja pri bolnikih z axSpA v primerjavi s populacijo z revmatoidnim artritisom (RA).
English: It is recommended to wait a minimum of 5 months following the mother's last Cimzia administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or liveattenuated vaccines to the infants.
Slovenian: Pred uporabo živih ali živih atenuiranih cepiv (npr. cepiva BCG) je priporočljivo počakati vsaj 5 mesecev po materini zadnji uporabi zdravila Cimzia med nosečnostjo, razen če korist cepljenja nedvomno odtehta teoretično tveganje pri uporabi živih ali živih atenuiranih cepiv pri dojenčkih.
English: People with more severe rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Slovenian: Osebe s hujšo obliko revmatoidnega artritisa, ki imajo to bolezen že daljši čas, so lahko izpostavljene nadpovprečnemu tveganju za vrsto raka, ki prizadene limfni sistem in se imenuje limfom.
English: Treatment with Cimzia must not be initiated in patients with a clinically important active infection, including chronic or localised infections, until the infection is controlled (see section 4.3).
Slovenian: Zdravljenja z zdravilom Cimzia ne smemo začeti pri bolnikih s klinično pomembno aktivno okužbo, vključno s kroničnimi ali lokaliziranimi okužbami, dokler okužba ni pod nadzorom (glejte poglavje
English: • menstrual cycle (monthly period) disorders including lack of bleeding, or heavy or irregular bleeding
Slovenian: • motnje menstrualnega cikla (menstruacije), vključno z izostankom krvavitve, ali močnimi ali nerednimi krvavitvami
English: Response rates and p-values for PASI and PGA were estimated based on a logistic regression model where missing data were imputed using multiple imputation based on the MCMC method.
Slovenian: Stopnje odziva in vrednosti p za PASI in PGA so bile ocenjene na podlagi modela logistične regresije, kjer so bili manjkajoči podatki vstavljeni z multiplo imputacijo na podlagi metode MCMC.
English: In addition, Studies RA-I and RA-II had a mandatory withdrawal for non-responders at Week 16, the majority of whom were on placebo.
Slovenian: Poleg tega je bila v okviru študij RA-I in RA-II za bolnike, ki se na zdravljenje niso odzivali in katerih večina je prejemala placebo, obvezna prekinitev zdravljenja po 16 tednih.
English: The primary endpoint of the study was the ACR 20 responder rate at week 34.
Slovenian: Primarni cilj študije je bil odziv ACR 20 v 34. tednu.
English: In women, ASAS20 responses were not statistically significantly different from placebo until after the Week 12 time point.
Slovenian: Pri ženskah so bili odzivi ASAS20 v primerjavi s placebom statistično značilno različni po 12. tednu.
English: In CIMPASI-1 and CIMPASI-2, sixty patients were antibody positive, 27 of these patients were evaluable for neutralizing antibodies and tested positive.
Slovenian: V študiji CIMPASI-1 in CIMPASI-2 je bilo šestdeset bolnikov pozitivnih na protitelesa, med njimi je bilo pri 27 možno oceniti nevtralizirajoča protitelesa in so imeli pozitiven rezultat testa.