FrancophonIA/ELRC3.0 huggingface dataset:
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of AMGEVITA, and in accordance with local recommendations.
Slovenian: Če se ugotovi latentna tuberkuloza, se mora pred uvedbo zdravila AMGEVITA začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
English: AMGEVITA is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Slovenian: d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
English: The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Slovenian: Pri bolnikih nad 65 let, ki so prejemali adalimumab, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
Slovenian: V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [P = 0,014]).
English: During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Slovenian: Med študijo je večina preiskovancev sočasno uporabljala metotreksat, manj pa jih je navedlo uporabo kortikosteroidov ali NSAID.
English: The active ingredient in AMGEVITA, adalimumab, is a human monoclonal antibody.
Slovenian: Učinkovina v zdravilu AMGEVITA, adalimumab, je humano monoklonsko protitelo.
English: This includes any possible side effects not listed in this leaflet (see section 4).
Slovenian: Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
English: D. Prepare and clean your injection site.
Slovenian: D. Pripravite in očistite mesto injiciranja.
English: Treatment with AMGEVITA should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom AMGEVITA se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Name and address of the manufacturers of the biological active substance Amgen Inc
Slovenian: Ime in naslov izdelovalcev biološke učinkovine Amgen Inc
English: If you use more AMGEVITA than you should
Slovenian: Če ste uporabili večji odmerek zdravila AMGEVITA, kot bi smeli
English: Certain vaccines may cause infections and should not be given while receiving AMGEVITA.
Slovenian: • Določena cepiva lahko povzročijo okužbe, zato se jih med zdravljenjem z zdravilom AMGEVITA ne sme uporabljati.
English: As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting AMGEVITA.
Slovenian: • Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom AMGEVITA preiskal glede znakov in simptomov tuberkuloze.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Slovenian: Poročali so tudi o melanomu in karcinomu Merkelovih celic pri bolnikih, zdravljenih z TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
English: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Slovenian: Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (see figure 3, P < 0.0001 from log rank test).
Slovenian: Adalimumab je značilno podaljšal čas do neuspeha zdravljenja v primerjavi s placebom (glejte sliko 3, p < 0,0001 iz testa log-rank).
English: No dose recommendations can be made.
Slovenian: Priporočila glede odmerjanja niso možna.
English: The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Slovenian: Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko mediani čas do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the new born.
Slovenian: Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Slovenian: Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali druge oportunistične okužbe, in sepso, in so lahko v redkih primerih smrtno nevarne.
English: ● Do not try to warm the syringe by using a heat source such as hot water or microwave.
Slovenian: ● Ne poskušajte ogrevati brizge z virom toplote, kot na primer z vročo vodo ali v mikrovalovni pečici.
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Slovenian: 12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Slovenian: Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
English: When done, release your thumb, and gently lift the syringe off of your skin.
Slovenian: I. Ko ste opravili, odmaknite palec in brizgo previdno dvignite od kože.
English: In patients who develop HBV reactivation, AMGEVITA should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila AMGEVITA prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: If active tuberculosis is diagnosed, AMGEVITA therapy must not be initiated (see section 4.3).
Slovenian: Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom AMGEVITA ne sme začeti (glejte poglavje 4.3).
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), paediatric ACR 50 response, and paediatric ACR 70 response.
Slovenian: Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Pediatric ACR 50 in Pediatric ACR 70.
English: Figure 2: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Slovenian: Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
English: Patients were permitted to be either disease-modifying, antirheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Slovenian: Bolniki lahko pred tem še niso prejemali imunomodulirajočih antirevmatičnih zdravil ali pa so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
English: Percent change in total fingernail NAPSI (%)
Slovenian: Odstotek spremembe v celem indeksu NAPSI
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabo natančno preberite navodilo, ker vsebuje pomembne podatke!
English: - On rare occasions, treatment with AMGEVITA could result in lupus-like syndrome.
Slovenian: • V redkih primerih zdravljenje z zdravilom AMGEVITA lahko povzroči lupusu podoben sindrom.
English: • AMGEVITA should only be used during a pregnancy if needed.
Slovenian: • Zdravilo AMGEVITA se med nosečnostjo lahko uporablja samo, če je potrebno.
English: vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Slovenian: Učinki povezani z vidom niso bili v korist adalimumabu v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.
Slovenian: Tarča adalimumaba je beljakovina ki se imenuje tumorje nekrotizirajoči faktor (TNFα), ki je vključen v imunski (obrambni) sistem in je prisoten v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
English: Very common Injection site reaction (including injection site erythema) Common
Slovenian: zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranje)
English: Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines.
Slovenian: Bolniki, ki prejemajo zdravilo AMGEVITA, lahko sočasno dobijo cepiva, razen živih cepiv.
English: Should treatment be interrupted, AMGEVITA may be re-introduced as appropriate.
Slovenian: Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom AMGEVITA znova uvesti, kakor je primerno.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rak, ki prizadene limfatični sistem) in levkemijo (rak, ki prizadene kri in kostni mozeg).
English: By attaching to TNFα, AMGEVITA decreases the process of inflammation in these diseases.
Slovenian: Z vezavo na TNFα zdravilo AMGEVITA zmanjša vnetni proces pri teh boleznih.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana uporaba.
English: - Do not inject into areas where the skin is tender, bruised, red, or hard.
Slovenian: - Ne injicirajte v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
English: What you need to know before you use AMGEVITA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo AMGEVITA
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Slovenian: Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Slovenian: Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
English: Excipients with known effects
Slovenian: Pomožne snovi z znanim učinkom
English: • angioedema (localised swelling of the skin);
Slovenian: • angioedem (lokalizirano otekanje kože);
English: Thus additional caution should be exercised in considering AMGEVITA treatment of these patients (see section 4.8).
Slovenian: Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom AMGEVITA pri teh bolnikih (glejte poglavje 4.8).
English: - The pre-filled pen has been dropped on a hard surface.
Slovenian: - vam je napolnjeni injekcijski peresnik padel na trdo površino.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju z zdravilom AMGEVITA pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom AMGEVITA ne sme nadaljevati (glejte poglavje 4.8).
English: Adverse Reaction unspecified (including cysts and polyps)*
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)*
English: Patients who had been randomised to placebo in Period A were assigned to receive placebo in Period B.
Slovenian: Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdovju B prejemali placebo.
English: Therefore, the combination of AMGEVITA and anakinra is not recommended (see section 4.5).
Slovenian: Zato kombinacija zdravila AMGEVITA in anakinre ni priporočljiva (glejte poglavje 4.5).
English: ● Belly, except for a 2 inch (5 centimetres) area around your belly button
Slovenian: ● Stegno ● Trebuh, razen 5 centimetrov v okolici popka
English: Patients participating in all phase 2 and phase 3 psoriasis studies were eligible to enrol into an openlabel extension trial, where adalimumab was given for at least an additional 108 weeks.
Slovenian: Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili lahko vključeni v odprto podaljšano preskušanje, v katerem so adalimumab prejemali vsaj še dodatnih 108 tednov.
English: What AMGEVITA is and what it is used for What you need to know before you use AMGEVITA How to use AMGEVITA
Slovenian: Kaj je zdravilo AMGEVITA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo AMGEVITA Kako uporabljati zdravilo AMGEVITA Možni neželeni učinki
English: What AMGEVITA is and what it is used for
Slovenian: Kaj je zdravilo AMGEVITA in za kaj ga uporabljamo
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Slovenian: PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 µg/ml (95 % IZ 0,4-47,6 in 1,9-10,5).
English: • Merkel cell carcinoma (a type of skin cancer);
Slovenian: • karcinom Merkelovih celic (tip kožnega raka);
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila AMGEVITA nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: If you accidentally inject AMGEVITA more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more.
Slovenian: Če pomotoma injicirate zdravilo AMGEVITA pogosteje, kot vam je naročil zdravnik ali farmacevt, se posvetujte z njim ali s farmacevtom in mu povejte, da ste uporabili večji odmerek.
English: Patients treated with AMGEVITA should be given the Patient Reminder Card.
Slovenian: Bolniki, ki se zdravijo z zdravilom AMGEVITA, morajo dobiti posebno opozorilno kartico za bolnika.
English: If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Slovenian: Če se vam med zdravljenjem ali po njem pojavijo nove spremembe na koži, ali če se vam spremeni videz obstoječih sprememb, morate to povedati zdravniku.
English: In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 17 and 18).
Slovenian: V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA.
Slovenian: V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila AMGEVITA.
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more.
Slovenian: Adalimumab so raziskali pri 9506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
English: Maintenance of clinical remission and response (percent of patients)
Slovenian: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
English: Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Slovenian: • Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
English: • Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Slovenian: • otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
English: D. Prepare and clean your injection site(s).
Slovenian: D. Pripravite in očistite mesto injiciranj(a).
English: Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Slovenian: Z upoštevanjem teh ugotovitev je adalimumab priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Slovenian: Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS < 1,3).
English: Single use only.
Slovenian: Za enkratno uporabo.
English: Patients should be tested for HBV infection before initiating treatment with AMGEVITA.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom AMGEVITA testirati na okužbo s HBV.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
Slovenian: Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see figure 2).
Slovenian: V obeh študijah je bil dokazan zgodnji in vzdrževan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
English: P value1
Slovenian: P vrednost1
English: ~10s
Slovenian: ~10 sek
English: Before you use an AMGEVITA pre-filled syringe, read this important information:
Slovenian: Pred uporabo napolnjene injekcijske brizge zdravila AMGEVITA preberite te pomembne informacije:
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient-years during an adalimumab trial in paediatric patients with Crohn's disease.
Slovenian: Poleg tega niso opazili nobenega malignoma tudi pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikov-let med študijami z adalimumabom pri pediatričnih bolnikih s Crohnovo boleznijo.
English: 14 weeks a Paediatric ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Slovenian: 14 tednov a Odzivi »Pediatric ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015 c p = 0,031
English: AMGEVITA may have a minor influence on your ability to drive, cycle or use machines.
Slovenian: Zdravilo AMGEVITA ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja s stroji.
English: Put the original package with any unused syringes back in the refrigerator.
Slovenian: Originalno pakiranje z neuporabljenimi brizgami dajte nazaj v hladilnik.
English: Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation.
Slovenian: Bolnike, pri katerih se med zdravljenjem z zdravilom AMGEVITA pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Slovenian: Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o manj hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
English: Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Slovenian: Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQI - Dermatology Life Quality Index).