FrancophonIA/ELRC3.0 huggingface dataset:
English: In a developmental toxicity study conducted in mice following administration of the same analogous antibody, and in cynomolgus monkeys using golimumab, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Slovenian: V študiji vpliva na razvoj na miših z uporabo istega analognega protitelesa oziroma v študiji na opicah Cynomolgus z uporabo golimumaba ni bilo nobenih znakov toksičnosti zdravila za samice, embriotoksičnosti ali teratogenosti.
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed.
Slovenian: V kliničnem preskušanju z drugim antagonistom TNF so opazili poslabšanje CHF in povečano umrljivost zaradi CHF.
English: • Push the open end of the pre-filled pen firmly against the skin at a 90-degree angle until the Safety Sleeve slides fully into the Clear Cover (Figure 6).
Slovenian: • Odprti konec napolnjenega injekcijskega peresnika močno pritisnite na kožo pod kotom 90 stopinj, dokler varnostni ovoj popolnoma ne zdrsne v prozorni ovoj (slika 6).
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in na škatli poleg oznake "EXP".
English: Specific studies of golimumab have not been conducted in patients with renal or hepatic impairment.
Slovenian: Specifičnih študij golimumaba pri bolnikih z okvaro ledvic ali jeter niso izvedli.
English: The induction study (PURSUIT-Induction) evaluated patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) who had an inadequate response to or failed to tolerate conventional therapies, or were corticosteroid dependent.
Slovenian: V indukcijski študiji (PURSUIT-Induction) so ocenili bolnike z zmerno do zelo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; endoskopska delna ocena ≥ 2), ki so se nezadostno odzvali na konvencionalne načine zdravljenja, jih niso prenašali ali so bili odvisni od kortikosteroidov.
English: The potential role of TNF-blocking therapy in the development of malignancies is not known.
Slovenian: Morebitna vloga zdravljenja z zaviralci TNF pri nastanku malignih bolezni ni znana.
English: In GO-BEFORE the change from baseline in the vdH-S score, a composite score of structural damage that radiographically measures the number and size of joint erosions and the degree of joint space narrowing in hands/wrists and feet, was used to assess the degree of structural damage.
Slovenian: V študiji GO-BEFORE so uporabili spremembo od začetne vrednosti rezultata vdH-S, ki je sestavljeni rezultat za strukturne okvare in na podlagi katerega radiografsko merimo število in velikost erozij v sklepih ter stopnjo zoženja sklepne špranje v rokah/zapestjih in stopalih za oceno stopnje strukturnih okvar.
English: • You can also use the lower stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
Slovenian: • Za injiciranje lahko uporabite tudi spodnji del trebuha (abdomna) pod popkom, razen približno 5 cm širokega dela tik pod popkom.
English: • Asthma, shortness of breath, wheezing
Slovenian: • astma, kratka sapa, piskanje v pljučih,
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
Slovenian: Zdravniku morate povedati, če sočasno z zdravilom Simponi jemljete azatioprin ali 6-merkaptopurin.
English: Other information
Slovenian: DRUGI PODATKI
English: The diagram below (see figure 1) shows what the “SmartJect” pre-filled pen looks like.
Slovenian: Spodnji diagram (glejte sliko 1) prikazuje, kako izgleda napolnjeni injekcijski peresnik “SmartJect”.
English: Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection.
Slovenian: Pri odločanju glede uporabe golimumaba pri bolnikih s kronično okužbo ali ponavljajočimi se okužbami v anamnezi je potrebna previdnost.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Slovenian: Ob pojavu zvišane telesne temperature, ki ne mine, hitrim nastankom podplutb ali krvavitev ali zelo bledega videza, nemudoma pokličite zdravnika.
English: • A statement that the brand name and batch number should be recorded.
Slovenian: • Navedbo glede potrebnega beleženja imena ter številke serije zdravila.
English: • Check the expiration date printed or written on the carton.
Slovenian: • Preverite rok uporabnosti, ki je natisnjen ali napisan na škatli.
English: Analyses were performed on both the All Treated (AT, N = 197) and Objective Signs of Inflammation (OSI, N = 158, defined by elevated CRP and/or evidence of sacroiliitis on MRI at baseline) populations.
Slovenian: Analize so bile narejene za obe populaciji: populacijo vseh zdravljenih (All Treated - AT, N = 197) in populacijo z objektivnimi znaki vnetja (Objective Signs of Inflammation - OSI, N = 158, opredeljeni z zvišanjem CRP in/ali dokazi sakroiliitisa na MRI v izhodišču).
English: Following a single subcutaneous injection of 100 mg, the absorption of golimumab was similar in the upper arm, abdomen, and thigh, with a mean absolute bioavailability of 51%.
Slovenian: Po enkratni subkutani injekciji 100 mg zdravila je bila absorpcija golimumaba podobna ne glede na to, ali je bilo zdravilo injicirano v nadlaht, trebuh ali stegno, srednja vrednost absolutne biološke uporabnosti pa je bila 51 %.
English: Through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general population.
Slovenian: V približno 4 letih spremljanja je bila incidenca nelimfomskih malignih bolezni (z izjemo nemelanomskega kožnega raka) podobna kot v splošni populaciji.
English: • Please make sure you also have a list of all other medicines that you are using with you at any visit to a health care professional.
Slovenian: • Prosimo, da ob vsakem obisku pri zdravniku s seboj prinesete tudi seznam vseh drugih zdravil, ki jih jemljete.
English: If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
Slovenian: Če se na ta zdravila ne boste dovolj dobro odzvali, boste dobili za zdravljenje vaše bolezni zdravilo Simponi.
English: • swelling of small blood vessels (vasculitis) (rare).
Slovenian: • otekanje malih krvnih žil (vaskulitis) (redko).
English: Psoriatic arthritis (PsA)
Slovenian: Psoriatični artritis (PsA)
English: Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in health-related quality of life as measured by the physical and mental component summary scores of the SF-36.
Slovenian: Zdravljenje z zdravilom Simponi je vodilo do bistvenega izboljšanja telesne funkcije, ki so jo ocenili z vprašalnikom HAQ DI, pa tudi do bistvenega izboljšanja z zdravjem povezane kakovosti življenja, ki so jo izmerili z rezultati za telesno in duševno komponento vprašalnika SF-36.
English: Simponi should be given concomitantly with MTX.
Slovenian: Zdravilo Simponi uporabljamo skupaj z MTX.
English: Check security seal
Slovenian: Preverite varnostni pečat
English: It is used in children 2 years of age and older for the treatment of polyarticular juvenile idiopathic arthritis.
Slovenian: Uporablja se pri otrocih, starih 2 leti ali več, za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa.
English: The needle cover contains latex rubber.
Slovenian: Ščitnik igle vsebuje lateksno gumo.
English: The needle cover should not be removed until you are ready to inject the medicine.
Slovenian: Pokrovčka igle ne smete sneti, dokler niste pripravljeni za injiciranje zdravila.
English: • Bronchitis
Slovenian: • bronhitis,
English: It may harm them,
Slovenian: mravljinčenjem in draženjem),
English: What is in this leaflet What Simponi is and what it is used for What you need to know before you use Simponi How to use Simponi Possible side effects How to store Simponi Contents of the pack and other information
Slovenian: Kaj je zdravilo Simponi in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Simponi Kako uporabljati zdravilo Simponi Možni neželeni učinki
English: Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Slovenian: Resne okužbe, ki so jih opazili pri bolnikih, zdravljenih z golimumabom, so vključevale tuberkulozo, bakterijske okužbe, vključno s sepso in pljučnico, invazivne glivne in ostale oportunistične okužbe.
English: Press button to inject (see figure 7)
Slovenian: Pritisnite na gumb za injiciranje (glejte sliko 7)
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Simponi.
Slovenian: Ta opozorilna kartica vsebuje pomembne podatke o varnosti, ki jih morate upoštevati pred in med zdravljenjem z zdravilom Simponi.
English: Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure (see section 4.3).
Slovenian: Bolnike je treba skrbno spremljati in pri tistih, ki se jim na novo pojavijo znaki srčnega popuščanja oziroma se ti poslabšajo, golimumab ukiniti (glejte poglavje 4.3).
English: Remove the needle cover (see figure 5)
Slovenian: Snemite pokrovček igle (slika 5)
English: • You can also use the stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
Slovenian: • Za injiciranje lahko uporabite tudi predel trebuha (abdomna) pod popkom, razen približno 5 cm širokega dela tik pod popkom.
English: No cases were reported in the controlled and uncontrolled periods of the nr-Axial SpA study (up to 1 year).
Slovenian: V kontroliranih in nekontroliranih obdobjih študije (do 1 leta) pri bolnikih z nr-aksialnim SpA niso poročali o nobenih primerih.
English: Common: Bone fractures
Slovenian: Pogosti: zlomi kosti
English: There may be a small amount of blood or liquid at the injection site.
Slovenian: Na mestu injiciranja bo morda majhna količina krvi ali tekočine.
English: Tell your doctor straight away if you get new or worsening symptoms of heart failure.
Slovenian: Nemudoma obvestite zdravnika, če se vam pojavijo ali poslabšajo simptomi srčnega popuščanja.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Slovenian: Dovoljeni so bili sočasni ustaljeni odmerki peroralnih aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev.
English: Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p < 0.05).
Slovenian: Statistično značilen odziv na zdravljenje, merjen z DAS28, so opazili tudi v 14. in 24. tednu (p < 0,05).
English: The pre-filled pen is now ready to use.
Slovenian: Napolnjen injekcijski peresnik je zdaj pripravljen za uporabo.
English: Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.
Slovenian: Uporaba zaviralcev TNF, vključno z golimumabom, je bila povezana s primeri novonastalih kliničnih simptomov in/ali rentgenskih znakov demielinizirajočih bolezni osrednjega živčevja, vključno z multiplo sklerozo ali s poslabšanjem teh znakov in simptomov in perifernimi motnjami demielinizacije.
English: Push and hold the pre-filled pen tip against the skin so the orange needle guard pushes up until it stops.
Slovenian: Konico napolnjenega injekcijskega peresnika pritisnite na kožo in jo držite, da oranžen ščitnik igle zdrsne navzgor, dokler se ne ustavi.
English: Concomitant stable doses of oral aminosalicylates, and/or immunomodulatory agents were permitted.
Slovenian: Dovoljeni so bili sočasni ustaljeni odmerki peroralnih aminosalicilatov in/ali imunomodulatorjev.
English: The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells.
Slovenian: Vezava humanega TNF na golimumab nevtralizira ekspresijo adhezijskih molekul E-selektina, žilne celične adhezijske molekule (VCAM)-1 in medcelične adhezijske molekule (ICAM)-1 na celični površini človeških endotelijskih celic, ki jo sproži TNF-α.
English: Ankylosing spondylitis
Slovenian: Ankilozirajoči spondilitis
English: • Chronic inflammatory condition of the lungs
Slovenian: • kronično vnetje pljuč,
English: • blood cancer (leukaemia) (rare).
Slovenian: • rak krvi (levkemija) (redko).
English: • When you are ready to inject, twist the cap slightly to break the security seal.
Slovenian: • Ko ste pripravljeni za injiciranje zdravila, malo obrnite pokrovček, da bo počil varnostni pečat.
English: Invasive fungal infections
Slovenian: Invazivne glivne okužbe
English: • Some of these reactions occurred after the first administration of Simponi.
Slovenian: • Nekatere od teh reakcij so se pojavile po prvi uporabi zdravila Simponi.
English: The needle cover on the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Slovenian: Ščitnik igle na napolnjenem injekcijskem peresniku je izdelan iz suhe naravne gume, ki vsebuje lateks, in lahko povzroča alergijske reakcije pri posameznikih, ki so občutljivi za lateks.
English: Non-radiographic axial spondyloarthritis (nr-Axial SpA) Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Neradiografski aksialni spondiloartritis (nr-aksialni SpA) Zdravilo Simponi je indicirano za zdravljenje odraslih s hudim aktivnim neradiografskim aksialnim spondiloartritisom z objektivnimi znaki vnetja, na katera kažeta zvišana vrednost C-reaktivnega proteina (CRP) in/ali magnetnoresonančno slikanje (MRI), ki se na nesteroidna protivnetna zdravila (NSAID) niso ustrezno odzvali ali jih ne prenašajo.
English: *CHOKING HAZARD!
Slovenian: *NEVARNOST ZADUŠITVE!
English: Tell your doctor straight away if you already have or get any symptoms of infection, during or after your treatment with Simponi.
Slovenian: Nemudoma obvestite zdravnika, če že imate simptome okužbe oziroma se vam ti pojavijo med ali po zdravljenju z zdravilom Simponi.
English: Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha' (TNF-α).
Slovenian: Zdravilo Simponi deluje tako, da zavira delovanje beljakovine, imenovane tumorje nekrotizirajoči faktor alfa (TNF-α).
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy.
Slovenian: Pri bolnikih, ki so bivali v krajih ali potovali v kraje, kjer so invazivne glivne okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, endemske, je treba pred uvedbo zdravljenja z golimumabom skrbno pretehtati koristi in tveganja zdravljenja s tem zdravilom.
English: Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:
Slovenian: Poliartikularni juvenilni idiopatski artritis pri otrocih, starih 2 leti ali več:
English: Sixty-eight percent (21/31) of antibody-positive patients had neutralising antibodies in vitro.
Slovenian: Oseminšestdeset odstotkov (21/31) bolnikov s pozitivnim izvidom na protitelesa je imelo nevtralizirajoča protitelesa in vitro.
English: In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness.
Slovenian: Pri bolnikih s tveganjem, ki so zdravljeni z golimumabom, je treba v primeru pojava resne sistemske bolezni posumiti na invazivno glivno okužbo.
English: Patients should be instructed to inject the prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack.
Slovenian: Bolnikom je treba naročiti, naj si injicirajo predpisano količino zdravila Simponi v skladu z obsežnimi navodili za uporabo, ki so priložena v pakiranju.
English: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Golimumab je treba pri bolnikih z blagim srčnim popuščanjem (razreda I ali II po klasifikaciji NYHA) previdno uporabljati.
English: Before you start using Simponi:
Slovenian: Preden začnete uporabljati zdravilo Simponi:
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with golimumab and is positive for antibodies against double-stranded DNA, treatment with golimumab should be discontinued (see section 4.8).
Slovenian: Če se po zdravljenju z golimumabom pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in ima bolnik pozitiven izvid za protitelesa proti dvojni vijačnici DNA, je treba zdravljenje z golimumabom ukiniti (glejte poglavje 4.8).
English: Keep out of reach of children.
Slovenian: Shranjujte nedosegljivo otrokom!
English: Patients with RA, PsA or AS who did not receive concomitant MTX had approximately 30% lower steady-state trough concentrations of golimumab than those who received golimumab with MTX.
Slovenian: Bolniki z RA, PsA ali AS, ki sočasno niso prejemali MTX, so imeli približno 30 % manjše najnižje koncentracije golimumaba v stanju dinamičnega ravnovesja od tistih, ki so prejemali golimumab skupaj z MTX.
English: In GO-FORWARD and GO-AFTER, statistically significant improvements were observed in fatigue as measured by functional assessment of chronic illness therapy-fatigue scale (FACIT-F).
Slovenian: V študijah GO-FORWARD in GO-AFTER so opazili statistično značilno izboljšanje utrujenosti, kar so merili s funkcionalno oceno na lestvici utrujenosti pri zdravljenju kronične bolezni (FACIT-F).
English: If you have not been trained, or have any questions, please contact your doctor, nurse or pharmacist.
Slovenian: Če niste opravili usposabljanja ali če imate kakršna koli vprašanja, prosimo, kontaktirajte zdravnika, medicinsko sestro ali farmacevta.
English: Hold pressure on your skin with a cotton ball or gauze pad until any bleeding stops.
Slovenian: S kosmom vate ali zložencem gaze pritisnite na kožo, dokler ne ustavite krvavitve.
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 prejeli druga zdravila.
English: • Leukaemia
Slovenian: • levkemija,
English: Do not rub your skin.
Slovenian: Kože ne smete drgniti.
English: Because immunogenicity analyses are product- and assay-specific, comparison of antibody rates with those from other products is not appropriate.
Slovenian: Ker so analize imunogenosti specifične za zdravilo in izbrano preiskavo, primerjava pogostnosti nastanka protiteles s pogostnostmi pri drugih zdravilih ni smiselna.
English: However, you and your doctor may decide that you may inject Simponi yourself.
Slovenian: Vendar se lahko skupaj z zdravnikom odločite, da si boste zdravilo Simponi injicirali sami.
English: • Remove air bubbles
Slovenian: • odstraniti mehurčke zraka,
English: Objective signs of inflammation population (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
Slovenian: Populacija z objektivnimi znaki vnetja (OSI) Placebo Simponi 50 mg Placebo Simponi 50 mg
English: Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi.
Slovenian: Nemudoma obvestite zdravnika, če se vam po zdravljenju z zdravilom Simponi pojavijo simptomi alergijske reakcije.
English: Thin Hidden Needle
Slovenian: Tanka skrita igla
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use before the baby receives any vaccine (for more information see section on vaccination).
Slovenian: Pomembno je, da preden vaš dojenček prejme katero koli cepivo, otrokovim zdravnikom in drugim zdravstvenim delavcem poveste za vašo uporabo zdravila Simponi (za več informacij glejte poglavje o cepljenju).
English: In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
Slovenian: V študiji pJIA faze III so do 48. tedna z metodo EIA, ki je tolerantna za zdravilo, zaznali protitelesa proti golimumabu pri 40 % (69/172) otrok, zdravljenih z golimumabom, pri čemer je bil pri večini titer manjši od 1:1.000.
English: Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis.
Slovenian: Nemudoma obvestite zdravnika, če so vam kadar koli postavili diagnozo demielinizirajoče bolezni, kot je multipla skleroza, oziroma če se vam pojavijo njeni simptomi.
English: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n reflects number of patients with baseline and week 16 MRI data SPARCC (Spondyloarthritis Research Consortium of Canada) ** p < 0.0001 for Simponi vs placebo comparisons * p < 0.05 for Simponi vs placebo comparisons
Slovenian: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n pomeni število bolnikov s podatki MRI v izhodišču in 16. tednu SPARCC (Spondyloarthritis Research Consortium of Canada - Kanadski konzorcij za raziskovanje spondilartritisa) ** p < 0,0001 za primerjave zdravila Simponi s placebom * p < 0,05 za primerjave zdravila Simponi s placebom
English: If possible, your child should be up to date with all vaccinations before using Simponi.
Slovenian: Če je mogoče, naj otrok pred uporabo zdravila Simponi opravi vsa potrebna cepljenja.
English: Simponi should not be used if the solution is discoloured, cloudy or containing visible foreign particles.
Slovenian: Zdravila Simponi se ne sme uporabiti, če je raztopina obarvana, motna ali vsebuje vidne tuje delce.
English: Patients treated with Simponi should be given the Patient Reminder Card.
Slovenian: Bolniki, ki se zdravijo z zdravilom Simponi, morajo dobiti opozorilno kartico za bolnika.
English: Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Slovenian: Zdravilo Simponi je indicirano za zdravljenje hudega, aktivnega ankilozirajočega spondilitisa pri odraslih, ki so se nezadovoljivo odzvali na običajno terapijo.
English: Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation.
Slovenian: Bolnike, pri katerih se med zdravljenjem z golimumabom pojavi nova okužba, je treba natančno spremljati in pri njih opraviti vse diagnostične preiskave.
English: When you are treated with Simponi, you might get infections more easily.
Slovenian: V času zdravljenja z zdravilom Simponi boste morda hitreje zboleli za okužbami.
English: In the controlled periods of pivotal trials, 5.4% of golimumab-treated patients had injection site reactions compared with 2.0% in control patients.
Slovenian: V kontroliranih obdobjih ključnih preskušanj je imelo 5,4 % bolnikov, zdravljenih z golimumabom, reakcije na mestu injiciranja, v primerjavi z 2,0 % bolnikov iz kontrolne skupine.