FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4).
Slovenian: Med najresnejše neželene učinke zdravila, o katerih so poročali pri golimumabu, sodijo resne okužbe (vključno s sepso, pljučnico, TB, invazivnimi glivnimi in oportunističnimi okužbami), motnje demielinizacije, reaktivacija okužbe s HBV, kongestivno srčno popuščanje, avtoimunski procesi (lupusu podoben sindrom), hematološke reakcije, resna sistemska preobčutljivost (vključno z anafilaktično reakcijo), vaskulitis, limfom in levkemija (glejte poglavje 4.4).
English: Choose injection site
Slovenian: Izberite mesto za injiciranje
English: How to use Simponi
Slovenian: Kako uporabljati zdravilo Simponi
English: If active tuberculosis is diagnosed, golimumab therapy must not be initiated (see section 4.3).
Slovenian: V primeru diagnoze aktivne tuberkuloze se zdravljenja z golimumabom ne sme uvesti (glejte poglavje 4.3).
English: In controlled and uncontrolled portions of the trials with a median follow-up of approximately 4 years, the incidence per 100 subject-years of infections was 81.1 events; 95% CI: 79.5, 82.8 for golimumab treated patients.
Slovenian: V kontroliranih in nekontroliranih delih preskušanj z medianim trajanjem spremljanja bolnikov približno 4 leta je bila incidenca okužb na 100 preiskovanec-let 81,1 dogodka; 95 % IZ: 79,5, 82,8 za bolnike, zdravljene z golimumabom.
English: At week 6, Simponi significantly improved quality of life as measured by change from baseline in a disease specific measure, IBDQ (inflammatory bowel disease questionnaire).
Slovenian: V 6. tednu je zdravilo Simponi v primerjavi z izhodiščem značilno izboljšalo kakovost življenja, merjeno s spremembo za bolezen specifične mere, vprašalnika IBDQ.
English: • Pull the cap off and throw it away after your injection.
Slovenian: • Snemite pokrovček in ga po injiciranju zavrzite.
English: Do not return this medicine to refrigerator if it has reached room temperature.
Slovenian: Če je zdravilo doseglo sobno temperaturo, ga ne vračajte v hladilnik.
English: In an exploratory clinical study, patients with severe persistent asthma received a golimumab loading dose (150% of the assigned treatment dose) subcutaneously at week 0 followed by golimumab 200 mg, golimumab 100 mg or golimumab 50 mg every 4 weeks subcutaneously through week 52.
Slovenian: Prijavljeni primeri v kliničnih študijah pri bolnikih z astmo V eksploratorni klinični študiji so bolniki s hudo persistentno astmo subkutano prejeli uvajalni odmerek golimumaba (150 % določenega terapevtskega odmerka) v tednu 0, potem pa so subkutano prejemali 200 mg golimumaba, 100 mg golimumaba ali 50 mg golimumaba na vsake 4 tedne, do 52. tedna.
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: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2.
Slovenian: Neželeni učinki, ki so jih opazili v kliničnih študijah in pri uporabi golimumaba v obdobju trženja po vsem svetu, so navedeni v preglednici 2.
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.
Slovenian: V študiji GO-FORWARD so pokazali klinično pomembno in statistično značilno izboljšanje z zdravjem povezane kakovosti življenja, merjene z oceno vprašalnika SF-36 (dela, povezanega s telesnim zdravjem) pri bolnikih, zdravljenih z zdravilom Simponi, v primerjavi s placebom v 24. tednu.
English: Treatment with 50 mg or 100 mg golimumab subcutaneous every 4 weeks during maintenance resulted in a mean steady-state trough serum concentration of approximately 0.9 ± 0.5 g/mL and 1.8 ± 1.1 g/mL, respectively.
Slovenian: Zdravljenje s 50 mg ali 100 mg golimumaba subkutano vsake 4 tedne med vzdrževalnim zdravljenjem je povzročilo povprečno najnižjo serumsko koncentracijo v stanju dinamičnega ravnovesja 0,9 ± 0,5 g/ml (odmerek 50 mg) in 1,8 ± 1,1 g/ml (odmerek 100 mg).
English: If you are being treated with Simponi, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last Simponi injection.
Slovenian: Med zdravljenjem z zdravilom Simponi ne smete zanositi, zato morate med zdravljenjem in vsaj še 6 mesecev po zadnji injekciji zdravila Simponi uporabljati zanesljivo kontracepcijsko zaščito.
English: Tell your doctor straight away if symptoms of TB appear during or after your treatment.
Slovenian: Nemudoma obvestite zdravnika, če se vam med zdravljenjem ali po njem pojavijo simptomi TB.
English: In the controlled and uncontrolled periods of pivotal trials through 1 year of follow-up, 3.5% of golimumab-treated patients and 2.3% of control patients were newly ANA-positive (at titres of 1:160 or greater).
Slovenian: V kontroliranih in nekontroliranih obdobjih ključnih preskušanj je bil v času enoletnega spremljanja bolnikov izvid na protitelesa ANA na novo pozitiven pri 3,5 % bolnikov, zdravljenih z golimumabom, in pri 2,3 % bolnikov iz kontrolne skupine (s titri 1:160 ali več).
English: • Feeling weak
Slovenian: • občutek šibkosti,
English: Available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses).
Slovenian: Razpoložljivi podatki kažejo, da je klinični odziv ponavadi dosežen v 12 do 14 tednih zdravljenja (po 4 odmerkih).
English: Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Slovenian: Zaradi narave neželenih učinkov, ki so jih opazili pri tej kombinirani terapiji, lahko pride do podobne toksičnosti tudi pri uporabi kombinacije anakinre in drugih zaviralcev TNF, zato kombiniranje golimumaba in anakinre ni priporočljivo.
English: Table 3 Improvements from baseline in ACR Ped components at week 16 Median percent improvement Simponi 30 mg/m b = 173
Slovenian: Preglednica 3 Izboljšanje komponent ACR Ped glede na izhodiščno vrednost v 16. tednu Mediani odstotek izboljšanja Simponi 30 mg/m b = 173
English: • Menstrual disorders
Slovenian: • menstrualne motnje.
English: • Look through the viewing window to make sure that the liquid in the pre-filled pen is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow.
Slovenian: • Poglejte skozi opazovalno okence in se prepričajte, da je tekočina v napolnjenem injekcijskem peresniku bistra do rahlo opalescentna (tj. da ima biserni sij) ter brezbarvna do svetlo rumena.
English: Ulcerative colitis (UC)
Slovenian: Ulcerozni kolitis (UK)
English: Simponi treatment resulted in significant improvements in physical function as assessed by changes from baseline in BASFI at weeks 14 and 24.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Simponi, se signifikantno izboljšanje telesne funkcije glede na BASFI kažejo v času 14. in 24. tedna.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Slovenian: Uporaba povzročiteljev okužb, kot so žive oslabljene bakterije (npr. instilacija BCG v mehur za zdravljenje raka), v druge terapevtske namene bi lahko povzročila klinične okužbe, vključno z razsejanimi okužbami, zato se priporoča, da se jih ne daje sočasno z golimumabom.
English: It is recommended that the conduct of these tests should be recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravnike, ki predpisujejo zdravilo, opozarjamo na tveganje za lažno negativne izvide tuberkulinskega kožnega testa zlasti pri bolnikih, ki so hudo bolni ali imajo oslabljen imunski sistem.
English: Non-radiographic axial spondyloarthritis
Slovenian: Neradiografski aksialni spondiloartrítis
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 8).
Slovenian: V 16. tednu se je pri vseh komponentah ACR Ped pokazalo klinično pomembno izboljšanje glede na izhodiščno vrednost (glejte preglednico 8).
English: Similar ACR 20 responses at week 14 were observed in patients with polyarticular arthritis with no rheumatoid nodules and asymmetric peripheral arthritis PsA subtypes.
Slovenian: Podobne odzive ACR 20 v 14. tednu so opazili pri bolnikih s podvrstami psoriatičnega artritisa, t.j.
English: Injection site selection for caregivers (see figure 4)
Slovenian: Izbira mesta za injiciranje za negovalce (glejte sliko 4)
English: Of these 70 patients, 64, 46 and 31 patients had an ACR 20/50/70 response, respectively.
Slovenian: Od teh 70 bolnikov jih je imelo 64 odziv ACR 20, 46 odziv ACR 50 in 31 odziv ACR 70.
English: SPARCC score as measured by MRI showed statistically significant reductions in SI joint inflammation at week 16 in patients treated with Simponi 50 mg compared to placebo (Table 6).
Slovenian: Rezultat SPARCC, merjen z MRI, je v 16. tednu pokazal statistično značilno zmanjšanje vnetja SI sklepov pri bolnikih, zdravljenih z zdravilom Simponi 50 mg, v primerjavi z bolniki, ki so prejemali placebo (preglednica 6).
English: 125 to < 135
Slovenian: 125 do < 135
English: Patients were randomly assigned to placebo, Simponi 50 mg and Simponi 100 mg and were allowed to continue concomitant DMARD therapy (MTX, SSZ and/or HCQ).
Slovenian: Te bolnike so naključno razporedili v skupine za prejemanje placeba, zdravila Simponi 50 mg ali zdravila Simponi 100 mg in so jim dovolili nadaljevati s sočasno terapijo DMARD (MTX, sulfasalazin in/ali hidroksiklorokvin).
English: The medicine should be injected within 5 minutes after the needle cover has been removed.
Slovenian: Zdravilo si injicirajte v roku 5 minut po odstranitvi pokrovčka igle.
English: What Simponi contains The active substance is golimumab.
Slovenian: Kaj vsebuje zdravilo Simponi Učinkovina je golimumab.
English: Each pre-filled pen can deliver 0.1 mL to 0.45 mL (corresponding to 10 mg to 45 mg golimumab) in increments of 0.05 mL.
Slovenian: Vsak napolnjen injekcijski peresnik lahko sprosti od 0,1 ml do 0,45 ml (kar ustreza od 10 mg do 45 mg golimumaba) v korakih po 0,05 ml.
English: • Inflammation of the blood vessels in your skin which results in rash
Slovenian: • vnetje krvnih žil v koži, ki se kaže kot izpuščaj.
English: • Lift the pre-filled pen from the injection site.
Slovenian: • Napolnjeni injekcijski peresnik dvignite z mesta injiciranja.
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after your last Simponi injection during pregnancy.
Slovenian: Vaš dojenček v obdobju 6 mesecev po vašem zadnjem odmerku zdravila Simponi, ki ste ga prejeli med nosečnostjo, ne sme prejeti "živega cepiva", kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
English: In the controlled period of UC trials of golimumab induction, serious infections were observed in 0.8% of golimumab-treated patients compared with 1.5% of control-treated patients.
Slovenian: V kontroliranem obdobju preskušanj indukcije z golimumabom pri bolnikih z UK so se resne okužbe pojavile pri 0,8 % bolnikov, zdravljenih z golimumabom, v primerjavi z 1,5 % bolnikov iz kontrolnih skupin.
English: Ask your doctor or pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom ali farmacevtom.
English: Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6).
Slovenian: Živa cepiva/povzročitelji okužb v terapevtske namene Živih cepiv se ne sme dajati sočasno z golimumabom (glejte poglavji 4.4 in 4.6).
English: During the Simponi Phase IIb and Phase III clinical trials in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), the incidence of lymphoma in golimumab-treated patients was higher than expected in the general population.
Slovenian: V kliničnih preskušanjih faze IIb in faze III z zdravilom Simponi pri bolnikih z revmatoidnim artritisom (RA), psoriatičnim artritisom (PsA) in ankilozirajočim spondilitisom (AS) je bila incidenca limfoma pri bolnikih, zdravljenih z golimumabom, večja od pričakovane incidence za splošno populacijo.
English: Wait 30 minutes to allow pre-filled syringe to reach room temperature
Slovenian: Počakajte 30 minut, da lahko napolnjena injekcijska brizga doseže sobno temperaturo
English: In controlled and uncontrolled portions of the studies with a median follow-up of approximately 4 years, the incidence per 100 subject-years of upper respiratory tract infections was 34.9 events; 95% CI: 33.8, 36.0 for golimumab treated patients.
Slovenian: V kontroliranih in nekontroliranih delih študij z medianim trajanjem spremljanja bolnikov približno 4 leta je bila incidenca okužb zgornjih dihal na 100 preiskovanec-let 34,9 dogodka; 95 % IZ: 33,8, 36,0 za bolnike, zdravljene z golimumabom.
English: Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Slovenian: Zdravilo Simponi, samo ali v kombinaciji z MTX, je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, pri katerih je bil odziv na prejšnje zdravljenje z DMARD nezadosten.
English: Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses).
Slovenian: Razpoložljivi podatki kažejo, da je klinični odziv ponavadi dosežen v 12 do 14 tednih zdravljenja (po 3 do 4 odmerkih).
English: Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2.
Slovenian: Začetni odmerek zdravila Simponi je 200 mg, ki mu sledi 100 mg v 2. tednu.
English: Check injection site
Slovenian: Preverite mesto injiciranja
English: • Hold the body of the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the area of skin that you previously cleaned.
Slovenian: Palec postavite na vrh glave bata, z drugo roko pa nežno stisnite kožo v gubo na predelu, ki ste ga pred tem očistili.
English: Common: Hypertension Uncommon: Thrombosis (such as deep venous and aortic), flushing Rare: Raynaud's phenomenon
Slovenian: Pogosti: hipertenzija Občasni: tromboza (npr. globoka venska tromboza in aortna tromboza), vročinski oblivi Redki: Raynaudov fenomen
English: • Do not remove the needle cover from the pre-filled syringe until instructed to do so.
Slovenian: • Pokrovčka igle ne snemajte z napolnjene injekcijske brizge, dokler ni to izrecno zahtevano v navodilu.
English: Injecting the medicine
Slovenian: Injiciranje zdravila
English: The 154 children who achieved an ACR Ped 30 response at week 16 entered Part 2 of the study, the randomised withdrawal phase, and received Simponi 30 mg/m2 (maximum 50 mg) + MTX or placebo + MTX every 4 weeks.
Slovenian: 154 otrok, ki je v 16. tednu doseglo odziv ACR Ped 30, so vključili v drugi del študije, in sicer v randomizirano fazo odtegnitve zdravila, v kateri so vsake 4 tedne prejeli 30 mg/m2 (največ 50 mg) zdravila Simponi in MTX ali placebo in MTX.
English: In the controlled period of pivotal trials, upper respiratory tract infection was the most common adverse reaction reported in 12.6% of golimumab-treated patients (incidence per 100 subject-years: 60.8; 95% CI: 55.0, 67.1) compared with 11.0% of control patients (incidence per 100 subject-years: 54.5; 95% CI: 46.1, 64.0).
Slovenian: V kontroliranem obdobju ključnih preskušanj je bil najpogostejši neželeni učinek okužba zgornjih dihal, ki se je pojavil pri 12,6 % bolnikov, zdravljenih z golimumabom (incidenca na 100 preiskovanec-let: 60,8; 95 % IZ: 55,0, 67,1) v primerjavi z 11,0 % bolnikov iz kontrolne skupine (incidenca na 100 preiskovanec-let: 54,5; 95 % IZ: 46,1, 64,0).
English: Choosing and preparing the injection site (see figure 2)
Slovenian: Izbira in priprava mesta za injiciranje (glejte sliko 2)
English: In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients.
Slovenian: V kontroliranem obdobju ključnih preskušanj pri bolnikih z RA, PsA, AS, nr-aksialnim SpA in UK je bil najpogostejši neželeni učinek zdravila okužba zgornjih dihal, ki se je pojavila pri 12,6 % bolnikov, zdravljenih z golimumabom, v primerjavi z 11,0 % bolnikov iz kontrolne skupine.
English: AFTER
Slovenian: POTEM
English: IMPORTANT: Do not lift the pre-filled pen from the skin during the injection.
Slovenian: POMEMBNO: Med injiciranjem napolnjenega injekcijskega peresnika ne dvigajte s kože.
English: If you have active psoriatic arthritis you will first be given other medicines.
Slovenian: Če imate aktiven psoriatični artritis, boste najprej prejeli druga zdravila.
English: The majority of children did not experience a flare between week 16 and week 48 (59% in the Simponi + MTX and 53% in the placebo + MTX groups, respectively; p = 0.41).
Slovenian: Pri večini otrok med 16. in 48. tednom ni prišlo do ponovnega zagona bolezni (59 % v skupini, ki je prejemala zdravilo Simponi in MTX ter 53 % v skupini, ki je prejemala placebo in MTX; p = 0,41).
English: At week 16, all ACR Ped components demonstrated clinically relevant improvement from baseline (see Table 3).
Slovenian: V 16. tednu se je pri vseh komponentah ACR Ped pokazalo klinično pomembno izboljšanje glede na izhodiščno vrednost (glejte preglednico 3).
English: • Eye allergy
Slovenian: • očesna alergija,
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including golimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Slovenian: Pri bolnikih, ki so prejemali antagonist TNF, vključno z golimumabom, in so kronični prenašalci tega virusa (t.j.
English: There was no specific clustering of any type of malignancy.
Slovenian: Pri tem niso opazili, da bi se določena vrsta malignoma pojavljala bolj pogosto.
English: Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton.
Slovenian: Zdravilo Simponi se lahko shranjuje pri temperaturah do največ 25 °C za enkratno obdobje do 30 dni, vendar ne dlje od prvotnega datuma izteka roka uporabnosti, natisnjenega na škatli.
English: At week 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Simponi-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Simponi, so v 24. tednu opazili izboljšanje parametrov periferne aktivnosti psoriatičnega artritisa (npr. števila oteklih sklepov, števila bolečih oziroma občutljivih sklepov, daktilitisa in entezitisa).
English: In this study, the incidence (95% CI) per 100 subject-years of follow-up in golimumab-treated subjects was 0.40 (0.01, 2.20) for lymphoma, 0.79 (0.10, 2.86) for non-melanoma skin cancers, and 1.99 (0.64, 4.63) for other malignancies.
Slovenian: V tej študiji je bila incidenca (95 % IZ) limfoma na 100 preiskovanec-let spremljanja v skupini, ki je prejemala golimumab, 0,40 (0,01, 2,20), medtem ko je za nemelanomske vrste kožnega raka znašala 0,79 (0,10, 2,86) in 1,99 (0,64, 4,63) za druge malignome.
English: Inject Simponi
Slovenian: Injicirajte zdravilo Simponi
English: Lymphoma
Slovenian: Limfom
English: 2% 9% p = 0.009 16% 24% Week 52 NA NA NA
Slovenian: 2 % 9 % p = 0,009 16 % 24 %
English: Common: Dizziness, headache, paraesthesia Uncommon: Balance disorders Rare: Demyelinating disorders (central and peripheral), dysguesia
Slovenian: Pogosti: omotica, glavobol, parestezija Občasni: motnje ravnotežja Redki: motnje demielinizacije (centralne in periferne), disgevzija
English: Pain as assessed by the Total Back Pain and Nocturnal Back Pain VAS, and disease activity as measured by ASDAS-C also showed statistically significant improvement from baseline to week 16 in patients treated with Simponi 50 mg compared to placebo (p < 0.0001).
Slovenian: Tudi bolečine, ocenjene z VAS za vse bolečine v hrbtu in za nočne bolečine v hrbtu, ter aktivnost bolezni, merjena z ASDAS-C, so se pri bolnikih, zdravljenih z zdravilom Simponi 50 mg, v primerjavi z bolniki, ki so prejemali placebo, od izhodišča do 16. tedna statistično značilno izboljšale (p < 0,0001).
English: Heart failure
Slovenian: Srčne bolezni
English: There have been reports of tuberculosis in patients receiving golimumab.
Slovenian: Pri bolnikih, ki so prejemali golimumab, so poročali o pojavu tuberkuloze.
English: • You can press a cotton ball or gauze over the injection site for 10 seconds.
Slovenian: • Zdaj pritisnite kosem vate ali gazo na mesto injiciranja za 10 sekund.
English: Simponi is supplied in a single use pre-filled pen called SmartJect or as a single use pre-filled syringe.
Slovenian: Zdravilo Simponi je na voljo v obliki napolnjenih injekcijskih peresnikov za enkratno uporabo, imenovanih SmartJect, ali v obliki napolnjenih injekcijskih brizg za enkratno uporabo.
English: Cases of active tuberculosis have occurred in patients treated with golimumab during and after treatment for latent tuberculosis.
Slovenian: Pri bolnikih, zdravljenih z golimumabom med ali po zdravljenju latentne tuberkuloze, so se pojavili primeri aktivne tuberkuloze.
English: Symptoms of nervous system disease can include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Slovenian: Simptomi bolezni živčevja lahko vključujejo spremembe vida, šibkost rok ali nog, odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: In the controlled period of pivotal trials, infections were observed in 23.0% of golimumab-treated patients (incidence per 100 subject-years: 132.0; 95% CI: 123.3, 141.1) compared with 20.2% of control patients (incidence per 100 subject-years: 122.3; 95% CI: 109.5, 136.2).
Slovenian: V kontroliranem obdobju ključnih preskušanj so opazili okužbe pri 23,0 % bolnikov, zdravljenih z golimumabom (incidenca na 100 preiskovanec-let: 132,0; 95 % IZ: 123,3, 141,1), v primerjavi z 20,2 % bolnikov iz kontrolne skupine (incidenca na 100 preiskovanec-let: 122,3; 95 % IZ: 109,5, 136,2).
English: • Upper respiratory tract infections, sore throat or hoarseness, runny nose
Slovenian: • okužbe zgornjih dihal, vnetje grla ali hripavost, izcedek iz nosu
English: • Hold the pre-filled syringe by its body with the covered needle pointing downward.
Slovenian: • Napolnjeno injekcijsko brizgo držite za trup, pri čemer naj bo igla, pokrita s pokrovčkom,
English: • Slow down the damage to your bones and joints.
Slovenian: • za upočasnitev napredovanja okvare kosti in sklepov,
English: Polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg For children with body weight of at least 40 kg, a 50 mg pre-filled pen or pre-filled syringe is available.
Slovenian: Poliartikularni juvenilni idiopatski artritis pri otrocih s telesno maso vsaj 40 kg Za otroke s telesno maso vsaj 40 kg sta na voljo 50 mg napolnjeni injekcijski peresnik ali napolnjena injekcijska brizga.
English: Patients receiving placebo + MTX were switched to Simponi 50 mg + MTX after week 24.
Slovenian: Bolniki, ki so prejemali placebo in MTX, so po 24. tednu prešli na zdravljenje z zdravilom Simponi 50 mg in MTX.