FrancophonIA/ELRC3.0 huggingface dataset:
English: • Check the expiration date (as indicated as “EXP”) on the pre-filled pen.
Slovenian: • Preverite rok uporabnosti zdravila (označeno z “EXP”) na napolnjenem injekcijskem peresniku.
English: How much Simponi is given Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Slovenian: Koliko zdravila Simponi uporabimo Revmatoidni artritis, psoriatični artritis in aksialni spondiloartritis, vključno z ankilozirajočim spondilitisom ter neradiografskim aksialnim spondiloartritisom:
English: PRE-FILLED PEN FOR PAEDIATRIC USE LABEL
Slovenian: NALEPKA ZA NAPOLNJENI INJEKCIJSKI PERESNIK ZA PEDIATRIČNO UPORABO
English: • To ensure proper injection, allow the pre-filled syringe to sit at room temperature outside the box for 30 minutes, out of the reach of children.
Slovenian: • Da si boste zdravilo zagotovo pravilno injicirali, morate napolnjeni injekcijski peresnik pustiti zunaj škatle na sobni temperaturi 30 minut, pri čemer mora biti nedosegljiv otrokom.
English: Simponi has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Simponi ima majhen vpliv na sposobnost vožnje in upravljanja strojev.
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 3.
Slovenian: Ključni rezultati za uporabo zdravila Simponi v odmerku 50 mg v 52. tednu so predstavljeni v Preglednici 3.
English: With concomitant use of MTX, treatment with 50 mg golimumab subcutaneously every 4 weeks resulted in a mean ( standard deviation) steady-state trough serum concentration of approximately 0.6  0.4 g/mL in RA patients with active RA despite MTX therapy, and approximately 0.5  0.4 g/mL in patients with active PsA and approximately 0.8  0.4 g/mL in patients with AS. Steady-state trough mean serum golimumab concentrations in patients with nr-Axial SpA were similar to those observed in patients with AS following subcutaneous administration of 50 mg golimumab every 4 weeks.
Slovenian: Pri sočasni uporabi MTX je zdravljenje s 50 mg golimumaba subkutano na vsake 4 tedne vodilo do srednje vrednosti (± standardna deviacija) najnižje serumske koncentracije v stanju dinamičnega ravnovesja približno 0,6 ± 0,4 g/ml pri bolnikih z RA z aktivnim RA kljub zdravljenju z MTX, približno 0,5 ± 0,4 g/ml pri bolnikih z aktivnim PsA in približno 0,8 ± 0,4 g/ml pri bolnikih z AS.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Simponi.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se pred uporabo zdravila Simponi posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Figure 9
Slovenian: Slika 9
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Slovenian: • Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, neradiografskega aksialnega spondiloartritisa ali ulceroznega kolitisa.
English: The first ‘click' means that the needle has been inserted and the injection has started.
Slovenian: • Slišali boste glasen ‘klik' - ne prestrašite se. Prvi ‘klik' pomeni, da je igla vstavljena in da se je injiciranje pričelo.
English: • Failure of the bone marrow to produce blood cells
Slovenian: • nezmožnost nastajanja krvnih celic v kostnem mozgu,
English: More Simponi-treated patients demonstrated sustained mucosal healing (patients with mucosal healing at both week 30 and week 54) in the 50 mg group (42%, nominal p < 0.05) and 100 mg group (42%, p < 0.005) compared with patients in the placebo group (27%).
Slovenian: Trajno zacelitev sluznice (zaceljena sluznica v 30. in 54. tednu) je doseglo več bolnikov, ki so prejemali zdravilo Simponi, tako prejemnikov odmerka 50 mg (42 %, nominalna vrednost p < 0,05) kot prejemnikov odmerka 100 mg (42 %, vrednost p < 0,005), v primerjavi z bolniki, ki so prejemali placebo (27 %).
English: Instructions for Use Simponi 45 mg/0.45 mL solution for injection in pre-filled pen, VarioJect For paediatric use
Slovenian: Navodila za uporabo Simponi 45 mg/0,45 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku VarioJect Za pediatrično uporabo
English: This trend was not observed in the PsA population.
Slovenian: Takšne tendence niso opazili v skupini bolnikov s PsA.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Slovenian: Zdravljenje morajo uvesti in nadzorovati usposobljeni zdravniki, ki imajo izkušnje s področja diagnostike in zdravljenja revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, neradiografskega aksialnega spondiloartritisa ali ulceroznega kolitisa.
English: How much Simponi is given
Slovenian: Koliko zdravila Simponi uporabimo
English: Keep Simponi pre-filled pen and all medicines out of the sight and reach of children.
Slovenian: Napolnjeni injekcijski peresnik zdravila Simponi ter vsa druga zdravila shranjujte nedosegljiva otrokom!
English: The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose.
Slovenian: Tveganje za določene neželene učinke je večje pri odmerku 100 mg v primerjavi z odmerkom 50 mg. Neželeni učinki se lahko pojavijo do več mesecev po zadnji injekciji.
English: There is no relevant use of Simponi in patients aged less than 2 years for the indication of pJIA.
Slovenian: Ustreznih indikacij za uporabo zdravila pri bolnikih s pJIA, mlajših od 2 let, ni.
English: Common: Asthma and related symptoms (such as wheezing and bronchial hyperactivity) Uncommon: Interstitial lung disease Gastrointestinal disorders
Slovenian: Pogosti: astma in sorodni simptomi (npr. piskanje v pljučih in hiperaktivnost bronhijev) Občasni: intersticijska pljučna bolezen
English: Simponi is available in packs containing 1 pre-filled pen.
Slovenian: Zdravilo Simponi je na voljo v pakiranju, ki vsebuje 1 napolnjen injekcijski peresnik.
English: Symptoms of leukaemia can include fever, feeling tired, frequent infections, easy bruising, and night sweats.
Slovenian: Simptomi levkemije lahko vključujejo zvišano telesno temperaturo, občutek utrujenosti, pogoste okužbe, nagnjenost k modricam in nočna potenja.
English: Patients treated with Simponi experienced significantly more improvements in health-related quality of life as assessed by ASQoL, EQ-5D, and physical and mental components of SF-36, and experienced significantly more improvements in productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI questionnaire than patients receiving placebo.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Simponi, je bilo značilno več izboljšanj z zdravjem povezane kakovosti življenja, ocenjene z ASQoL, EQ-5D ter telesno in duševno komponento SF-36, kot pri bolnikih, ki so prejemali placebo.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Slovenian: Zdravljenje morajo uvesti in nadzorovati usposobljeni zdravniki, ki imajo izkušnje s področja diagnostike in zdravljenja revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, neradiografskega aksialnega spondiloartritisa ali ulceroznega kolitisa.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis:
Slovenian: Revmatoidni artritis, psoriatični artritis in aksialni spondiloartritis, vključno z ankilozirajočim spondilitisom ter neradiografskim aksialnim spondiloartritisom:
English: 155 to < 165
Slovenian: 155 do < 165
English: Tap the pre-filled pen gently with your finger near the viewing window.
Slovenian: S prstom nežno potrkajte na napolnjeni injekcijski peresnik v bližini okenca.
English: • If you are less than 2 weeks late, inject the forgotten dose as soon as you remember and stay on your original schedule.
Slovenian: • če zamujate manj kot 2 tedna, injicirajte pozabljeni odmerek takoj, ko se spomnite, in nadaljujte s prvotnim režimom odmerjanja zdravila.
English: Pre-specified subgroup analyses of the primary endpoint by baseline CRP (≥ 1 mg/dL vs < 1 mg/dL) demonstrated higher flare rates in placebo + MTX vs Simponi + MTX treated subjects among subjects with baseline CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068).
Slovenian: Analize primarnega opazovanega dogodka pri vnaprej določeni podskupini glede na izhodiščni CRP (≥ 1 mg/dl v primerjavi z < 1 mg/dl) so med osebami z izhodiščnim CRP ≥ 1 mg/dl pokazale višjo stopnjo ponovnega zagona bolezni pri tistih, zdravljenih s placebom in MTX (87 %), v primerjavi s tistimi, zdravljenimi z zdravilom Simponi in MTX (40 %) (p = 0,0068).
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zaviralci TNF, vključno z golimumabom, so poročali o melanomu in karcinomu Merklovih celic (glejte poglavje 4.8).
English: Symptoms of heart failure include shortness of breath or swelling of your feet.
Slovenian: Simptomi srčnega popuščanja vključujejo kratko sapo ali otekanje stopal.
English: Preparing for use of the pre-filled syringe
Slovenian: Priprava za uporabo napolnjene injekcijske brizge
English: Simponi induction only.
Slovenian: Samo indukcija z zdravilom Simponi.
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of golimumab therapy.
Slovenian: Pri bolnikih, ki so imeli že pred zdravljenjem demielinizirajočo bolezen oziroma se jim je ta pojavila pred kratkim, je treba pred uvedbo zdravljenja z golimumabom skrbno pretehtati koristi in tveganja zdravljenja z zaviralci TNF.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: In the controlled period of RA and AS pivotal trials, ALT elevations ≥ 5 x ULN were uncommon and seen in more golimumab-treated patients (0.4% to 0.9%) than control patients (0.0%).
Slovenian: V kontroliranem obdobju ključnih preskušanj pri bolnikih z RA in AS so bila zvišanja vrednosti ALT ≥ 5 x ZMN občasna in so jih opažali več pri bolnikih, zdravljenih z golimumabom (0,4 % do 0,9 %), kot pri tistih iz kontrolne skupine (0,0 %).
English: HCP.
Slovenian: CHF.
English: Some of these infections have been fatal.
Slovenian: Nekatere od njih so bile smrtne.
English: Symptoms of heart failure can include shortness of breath or swelling of your feet.
Slovenian: Simptomi srčnega popuščanja lahko vključujejo kratko sapo ali otekanje stopal.
English: Defined as a Mayo score ≤ 2 points, with no individual subscore > 1
Slovenian: Opredeljeno kot ocena Mayo ≤ 2 točki in nobena posamezna ocena > 1 Opredeljeno kot 0 ali 1 na endoskopskem delu ocene Mayo.
English: • The medicine should be injected within 5 minutes after the cap has been removed.
Slovenian: • Zdravilo si injicirajte v roku 5 minut po odstranitvi pokrovčka.
English: • Do not hold by the plunger head, plunger, needle guard wings, or needle cover.
Slovenian: • Napolnjene injekcijske brizge ne smete držati za glavo bata, sam bat, krila ščitnika igle ali pokrovček igle.
English: Keep pushing the pre-filled pen against the skin.
Slovenian: Napolnjeni injekcijski peresnik še naprej pritiskajte na kožo.
English: Hold firmly.
Slovenian: Ne zamrzujte.
English: Simponi is registered in 50 mg and 100 mg strengths for subcutaneous administration.
Slovenian: Zdravilo Simponi ima dovoljenje za promet v jakostih 50 mg in 100 mg za subkutano uporabo.
English: Preparing injection site
Slovenian: Priprava mesta za injiciranje
English: • Feeling sick (nausea)
Slovenian: • občutek slabosti (siljenje na bruhanje),
English: Tap air bubbles to top Hold the pre-filled pen upright with the blue cap pointing up.
Slovenian: Zračne mehurčke spravite na vrh Napolnjen injekcijski peresnik držite pokonci, tako da modri pokrovček gleda navzgor.
English: By study design, patients in the long-term extension may have switched between the 50 mg and 100 mg Simponi doses at the discretion of the study physician.
Slovenian: V skladu z načrtom študije so bolniki v dolgotrajnem podaljšanju lahko po presoji zdravnika zamenjali med 50-mg in 100-mg odmerkom zdravila Simponi.
English: In GO-FORWARD, the (co-)primary endpoints were the percentage of patients achieving an ACR 20 response at week 14 and the improvement from baseline in Health Assessment Questionnaire (HAQ) at week 24.
Slovenian: V študiji GO-FORWARD je bil primarni opazovani dogodek sestavljen iz odstotka bolnikov, ki so dosegli odziv ACR 20 v 14. tednu in izboljšanje rezultatov vprašalnika za oceno zdravstvenega stanja (Health Assessment Questionnaire - HAQ) v 24. tednu glede na začetek študije.
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Slovenian: • Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje revmatoidnega artritisa, poliartikularnega juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, neradiografskega aksialnega spondiloartritisa ali ulceroznega kolitisa.
English: Cases of leukaemia have been reported in patients treated with golimumab.
Slovenian: Pri bolnikih, zdravljenih z golimumabom, so poročali o primerih levkemije.
English: CARTON FOR 1 PRE-FILLED PEN AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA 1 NAPOLNJEN INJEKCIJSKI PERESNIK KOT VMESNA OVOJNINA/DEL VEČKRATNEGA PAKIRANJA (BREZ MODREGA OKENCA)
English: Symptoms of lymphoma can include swelling of the lymph nodes, weight loss, or fever.
Slovenian: Simptomi limfoma lahko vključujejo otekanje bezgavk, izgubo telesne mase ali zvišano telesno temperaturo.
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 2).
Slovenian: V 52. tednu je bil pri celotni populaciji odstotek bolnikov, ki so dosegli odziv ACR, v skupini, ki je prejemala zdravilo Simponi 50 mg in MTX, na splošno višji, vendar ne značilno drugačen kot v skupini, ki je prejemala samo MTX (glejte Preglednico 2).
English: Each pre-filled syringe contains 41 mg sorbitol per 100 mg dose.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 41 mg sorbitola na 100 mg odmerek.
English: Do not touch this area again before giving the injection.
Slovenian: Preden si date injekcijo, se tega mesta ne smete več dotakniti.
English: Symptoms can include yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever, feeling sick, being sick, and feeling very tired.
Slovenian: Simptomi lahko vključujejo porumenelost kože in oči, temno rjavo obarvan urin, bolečine na desni strani trebuha, zvišano telesno temperaturo, občutek slabosti, slabost in občutek hude utrujenosti.
English: 1 mL contains 100 mg golimumab.
Slovenian: 1 ml vsebuje 100 mg golimumaba.
English: At week 52 in the overall population, the percentage of patients in the Simponi 50 mg + MTX group who achieved an ACR response was generally higher but not significantly different when compared with MTX alone (see Table 4).
Slovenian: V 52. tednu je bil pri celotni populaciji odstotek bolnikov, ki so dosegli odziv ACR, v skupini, ki je prejemala zdravilo Simponi 50 mg in MTX, na splošno višji, vendar ne značilno drugačen kot v skupini, ki je prejemala samo MTX (glejte preglednico 4).
English: Symptoms can include fever, headache, weight loss, night sweats, rash, and nerve problems such as numbness and tingling.
Slovenian: Simptomi lahko vključujejo zvišano telesno temperaturo, glavobol, izgubo telesne mase, nočna potenja, izpuščaj in težave z živci, kot sta odrevenelost in mravljinčenje.
English: Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Slovenian: Simptomi okužbe vključujejo zvišano telesno temperaturo, kašelj, kratko sapo, gripi podobne simptome, drisko, rane, težave z zobmi ali pekoč občutek pri odvajanju urina.
English: Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen are included in the pack.
Slovenian: Obsežna navodila za pripravo in dajanje zdravila Simponi v napolnjenem injekcijskem peresniku so priložena v pakiranju.
English: Patients treated with golimumab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and 4.6).
Slovenian: Cepljenja/povzročitelji okužb v terapevtske namene Bolniki, zdravljeni z golimumabom, so lahko sočasno cepljeni, vendar ne z živimi cepivi (glejte poglavji 4.5 in 4.6).
English: If this happens, talk to your doctor or pharmacist.
Slovenian: Če se to zgodi, se posvetujte z zdravnikom ali s farmacevtom.
English: Set prescribed dose
Slovenian: Nastavite predpisani odmerek
English: Remove cap Keep holding the pre-filled pen upright, then twist and pull the cap to remove.
Slovenian: Napolnjen injekcijski peresnik še naprej držite pokonci, nato zasučite in potegnite pokrovček, da ga boste odstranili.
English: Patients with body weight greater than or equal to 80 kg Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter (see section 5.1).
Slovenian: Začetni odmerek zdravila Simponi je 200 mg, ki mu sledi 100 mg v 2. tednu, nato 100 mg vsake 4 tedne (glejte poglavje 5.1).
English: Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).
Slovenian: Povzročiteljev okužb v terapevtske namene se ne sme dajati sočasno z golimumabom (glejte poglavje 4.4).
English: • Do not use the pre-filled pen if the seal is broken.
Slovenian: • Napolnjenega injekcijskega peresnika ne smete uporabljati, če je pečat počen.
English: 1 pre-filled syringe) given once a month, on the same date each month.
Slovenian: 1 napolnjene injekcijske brizge) enkrat na mesec, vsak mesec na isti datum.
English: • Read the Simponi package leaflet carefully before you start using this medicine.
Slovenian: • Pred začetkom uporabe zdravila natančno preberite priloženo navodilo za uporabo.
English: A drug-tolerant EIA method was used in the pJIA study for the detection of antibodies to golimumab.
Slovenian: Za detekcijo protiteles proti golimumabu so v študiji pJIA uporabili za zdravilo tolerantno metodo EIA.
English: Psoriasis Area and Severity Index
Slovenian: Indeks površine psoriaze in jakosti bolezni (PASI)
English: In the controlled and uncontrolled period of pivotal trials with a median follow-up of up to 3 years, malignancies besides melanoma, non-melanoma skin cancer and lymphoma were diagnosed in 5 placebo-treated, 21 golimumab 50 mg-treated and 34 golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.48 (0.36, 0.62) for combined golimumab and 0.87 (0.28, 2.04) for placebo (see section 4.4).
Slovenian: V kontroliranih in nekontroliranih obdobjih ključnih preskušanj z medianim trajanjem spremljanja bolnikov do 3 let so diagnozo drugih malignomov poleg melanoma, nemelanomskega kožnega raka in limfoma postavili pri 5 preiskovancih, ki so prejemali placebo, 21 preiskovancih, zdravljenih s 50 mg golimumaba, in 34 preiskovancih, zdravljenih s 100 mg golimumaba z naslednjima incidencama (95 % IZ) na 100 preiskovanec-let spremljanja: 0,48 (0,36, 0,62) skupno za golimumab in 0,87 (0,28, 2,04) za placebo (glejte poglavje 4.4).
English: Test _______________
Slovenian: Preiskava _______________
English: Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 20,5 mg sorbitola na 50 mg odmerek.
English: In controlled and uncontrolled periods of the UC pivotal trials with a median follow-up of approximately 2 years, the proportion of patients with mild ALT elevations was 24.7% in patients receiving golimumab during the maintenance portion of the UC study.
Slovenian: V kontroliranih in nekontroliranih obdobjih ključnih preskušanj pri bolnikih z UK z medianim trajanjem spremljanja bolnikov približno 2 leti je bil delež bolnikov z blagimi zvišanji ALT med vzdrževalnim delom študije UK med prejemniki golimumaba 24,7 %.
English: In the controlled and uncontrolled periods of the RA and PsA pivotal trials, with a median follow-up of approximately 5 years, the incidence of mild ALT elevations was similar in golimumab-treated and control patients in RA and PsA studies.
Slovenian: V kontroliranih in nekontroliranih obdobjih ključnih preskušanj pri bolnikih z RA in PsA z medianim trajanjem spremljanja bolnikov približno 5 let je bila incidenca blagega zvišanja vrednosti ALT pri bolnikih, zdravljenih z golimumabom, podobna kot pri tistih iz kontrolne skupine v študijah RA in PsA.
English: 145 to < 155
Slovenian: 145 do < 155
English: IMPORTANT: Do not press on the orange needle guard before the injection.
Slovenian: POMEMBNO: Pred injiciranjem ne pritisnite na oranžen ščitnik igle, saj se bo sicer zaklenil in ne boste prejeli odmerka.
English: • Low white blood cell counts
Slovenian: • majhno število belih krvnih celic,
English: Simponi Patient Reminder Card
Slovenian: Opozorilna kartica za bolnika za zdravilo Simponi
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased Uncommon: Cholelithiasis, hepatic disorders Skin and subcutaneous tissue disorders
Slovenian: Pogosti: zvišana vrednost alanin-aminotransferaze, zvišana vrednost aspartat-aminotransferaze Občasni: holelitiaza, jetrne bolezni
English: Do not inject if the liquid is the wrong colour, cloudy or has large particles.
Slovenian: Ne injicirajte zdravila, če tekočina ni prave barve, je motna ali vsebuje velike delce.
English: In each of the RA studies by study design, patients in the long-term extension may have switched between the 50 mg and 100 mg Simponi doses at the discretion of the study physician.
Slovenian: V skladu z načrtom vsake izmed študij revmatoidnega artritisa so bolniki v dolgotrajnem podaljšanju po presoji zdravnika lahko zamenjali med 50-mg in 100-mg odmerkom zdravila Simponi.
English: Do not use the pre-filled syringe if the liquid is the wrong colour, cloudy, or contains larger particles.
Slovenian: Napolnjene injekcijske brizge ne smete uporabiti, če je tekočina napačne barve, motna ali vsebuje večje delce.
English: Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun. sarcoidosis (rare).
Slovenian: Simptomi lahko vključujejo bolečine v sklepih ali izpuščaj na licih ali rokah, ki je občutljiv na sonce.