FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving golimumab should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.
Slovenian: Bolnike, ki prejemajo golimumab, vključno z bolniki z negativnimi testi za latentno tuberkulozo, z bolniki, ki se zdravijo za latentno tuberkulozo, ali z bolniki, ki so bili predhodno zdravljeni za okužbo s tuberkulozo, je treba skrbno spremljati glede znakov in simptomov aktivne tuberkuloze.
English: Date _______________
Slovenian: Datum _______________
English: Improvement in C-reactive protein (CRP) levels were observed relative to placebo groups and treatment with Simponi resulted in significant reductions from baseline in serum levels of IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 and vascular endothelial growth factor (VEGF) compared to control treatment.
Slovenian: Zdravljenje z zdravilom Simponi je v primerjavi s kontrolno skupino povzročilo tudi pomembno zmanjšanje serumske koncentracije IL-6, ICAM-1, matriksne metaloproteinaze (MMP)-3 in žilnega endotelijskega rastnega faktorja (VEGF) glede na izhodišče.
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-RAISE) in 356 adult patients with active ankylosing spondylitis (defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and a VAS for total back pain of ≥ 4, on a scale of 0 to 10 cm).
Slovenian: Varnost in učinkovitost zdravila Simponi so ovrednotili v multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji (GO-RAISE) pri 356 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom (opredeljenim z Bathovim indeksom aktivnosti ankilozirajočega spondilitisa (BASDAI) ≥ 4 in VAS za skupno jakost bolečin v hrbtu ≥ 4 na lestvici od 0 do 10 cm).
English: Common: Pruritus, rash, alopecia, dermatitis Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous) Musculoskeletal and connective tissue disorders
Slovenian: Pogosti: pruritus, izpuščaj, alopecija, dermatitis Občasni: bulozne kožne reakcije, psoriaza (novonastala ali poslabšanje že obstoječe psoriaze, palmarno/plantarna in pustulozna), urtikarija Redki: lihenoidne reakcije, luščenje kože, vaskulitis (kožni) Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: • Inject the dose promptly after removing the needle cover.
Slovenian: • Odmerek si injicirajte takoj po snetju pokrovčka igle.
English: • Tell your doctor if you are a carrier or if you have or have had HBV before you are given
Slovenian: • Preden dobite zdravilo Simponi, zdravnika obvestite, če ste prenašalec HBV oziroma če imate ali ste imeli HBV.
English: The safety and efficacy of Simponi was evaluated in a randomised, double-blind, placebo-controlled, withdrawal study (GO-KIDS) in 173 children (2 to 17 years of age) with active pJIA with at least 5 active joints and an inadequate response to MTX.
Slovenian: Varnost in učinkovitost zdravila Simponi so ocenili v randomizirani, dvojno slepi, s placebom nadzorovani študiji odtegnitve zdravila (GO-KIDS) pri 173 otrocih (starih od 2 do 17 let) z aktivnim pJIA z vsaj 5 aktivno prizadetimi sklepi in nezadostnim odzivom na MTX.
English: Table 6 Key efficacy outcomes from GO-REVEAL
Slovenian: Preglednica 6 Ključni rezultati glede učinkovitosti iz študije GO-REVEAL
English: Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator).
Slovenian: Na škatlo napišite novi datum izteka roka uporabnosti, ki vključuje dan/mesec/leto (do 30 dni od dne, ko se zdravilo vzame iz hladilnika).
English: If you have active rheumatoid arthritis you will first be given other medicines.
Slovenian: Če imate aktiven revmatoidni artritis, boste najprej prejeli druga zdravila.
English: In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Slovenian: V kontroliranih obdobjih ključnih preskušanj in v času približno 4-letnega spremljanja bolnikov je bila incidenca nelimfomskih malignomov (z izjemo nemelanomskega kožnega raka) pri skupini, ki je prejemala golimumab, podobna kot pri kontrolnih skupinah.
English: • Pull the needle cover straight off and throw it away after your injection.
Slovenian: • Pokrovček igle potegnite naravnost z igle in ga po injiciranju zavrzite.
English: Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen or the pre-filled syringe are given in the package leaflet.
Slovenian: Obsežna navodila za pripravo in dajanje zdravila Simponi v napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi so podana v navodilu za uporabo.
English: Write the new expiry date on the back panel of the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator).
Slovenian: Na zadnjo stran škatle napišite novi datum izteka roka uporabnosti, ki vključuje dan/mesec/leto (do 30 dni od dne, ko se zdravilo vzame iz hladilnika).
English: In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in 1.2% of golimumab-treated patients and 1.2% of control-treated patients.
Slovenian: V kontroliranem obdobju preskušanj pri bolnikih z RA, PsA, AS in nr-aksialnim SpA so opazili resne okužbe pri 1,2 % bolnikov, zdravljenih z golimumabom, in pri 1,2 % bolnikov, zdravljenih s primerjalnim zdravilom.
English: In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
Slovenian: V kontroliranih preskušanjih faze IIb in/ali faze III pri bolnikih z RA, PsA, AS, nr-aksialnim SpA, hudo persistentno astmo in preskušanjih faze II/III pri bolnikih z UK se pri nobenem bolniku, zdravljenem z golimumabom, niso pojavile anafilaktične reakcije.
English: Choosing and preparing the injection site (see figure 3)
Slovenian: Izbira in priprava mesta za injiciranje (glejte sliko 3)
English: In GO-BEFORE, the co-primary endpoints were the percentage of patients achieving ACR 50 response at week 24 and the change from baseline in the van der Heijde-modified Sharp (vdH-S) score at week 52.
Slovenian: V študiji GO-BEFORE je bil primarni opazovani dogodek sestavljen iz odstotka bolnikov, ki so dosegli odziv ACR 50 v 24. tednu, in spremembe rezultata na po Sharpu modificirani lestvici van der Heijde (vdH-S) v 52. tednu glede na izhodiščne vrednosti.
English: • Bone fractures
Slovenian: • zlomi kosti,
English: • Superficial fungal infections
Slovenian: • površinske glivične okužbe,
English: Check the liquid in the pre-filled syringe
Slovenian: Preverite tekočino v napolnjeni injekcijski brizgi
English: • if the dose is less than 2 weeks late, the patient should inject the forgotten dose and stay on the original schedule.
Slovenian: • če je bolnik zamudil z odmerkom manj kot 2 tedna, si mora injicirati pozabljeni odmerek in ohraniti prvotni režim odmerjanja.
English: For patients weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available.
Slovenian: Za bolnike, ki tehtajo manj kot 40 kg, je na voljo napolnjen injekcijski peresnik 45 mg/0.45 ml.
English: Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Slovenian: Simptomi lahko vključujejo spremembe vida, šibkost rok ali nog ali odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritis and irritation)
Slovenian: Občasni: motnje vida (npr. zamegljen vid in zmanjšana ostrina vida), konjunktivitis, očesne alergije (na primer pruritus in draženje)
English: • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
Slovenian: • aksialnega spondiloartritisa, vključno z ankilozirajočim spondilitisom in neradiografskim aksialnim spondiloartritisom,
English: Solution for injection in pre-filled pen (injection), VarioJect
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcija), VarioJect
English: • Ulcerative colitis
Slovenian: • ulceroznega kolitisa.
English: If you have not been trained, please contact your doctor, nurse or pharmacist to schedule a training session.
Slovenian: Če vam tega še niso pokazali, se obrnite na zdravnika, medicinsko sestro ali farmacevta, da se boste dogovorili za to usposabljanje.
English: Preparing for use of the pre-filled syringe Choosing and preparing the injection site Injecting the medicine After the injection
Slovenian: Priprava za uporabo napolnjenega injekcijskega peresnika Izbira in priprava mesta za injiciranje Injiciranje zdravila
English: • Sensation of heart beating irregularly
Slovenian: • občutek nepravilnega srčnega utripa,
English: o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of 2 pre-filled syringes) given once a month, on the same date each month.
Slovenian: o Če tehtate več kot 100 kg, vam bo zdravnik morda povečal odmerek na 100 mg (vsebina 2 napolnjenih injekcijskih peresnikov) enkrat na mesec, vsak mesec na isti datum.
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Slovenian: Pri bolnikih z revmatoidnim artritisom in dolgotrajno, močno aktivno vnetno boleznijo, je osnovno tveganje za limfom in levkemijo povečano, kar dodatno zaplete oceno tveganja.
English: • There may be a small amount of blood or liquid at the injection site.
Slovenian: • Na mestu injiciranja boste morda opazili majhno količino krvi ali tekočine.
English: Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma* Blood and lymphatic system disorders
Slovenian: Občasni: novotvorbe (npr. kožni rak, ploščatocelični karcinom in melanocitni nevus) Redki: limfom, levkemija, melanom, karcinom Merklovih celic Neznana pogostnost: hepatosplenični T-celični limfom* Bolezni krvi in limfatičnega sistema Pogosti: levkopenija (vključno z nevtropenijo), anemija Občasni: trombocitopenija, pancitopenija Redki: aplastična anemija, agranulocitoza
English: After removing the pre-filled pen or the pre-filled syringe from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi.
Slovenian: Ko bolnik vzame napolnjen injekcijski peresnik ali napolnjeno injekcijsko brizgo iz hladilnika, mora počakati 30 minut, preden si injicira zdravilo Simponi, da bosta peresnik oziroma brizga dosegla sobno temperaturo.
English: The efficacy of Simponi through week 6 was assessed in this study.
Slovenian: V tej študiji so ocenili učinkovitost zdravila Simponi do 6. tedna.
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Slovenian: Pri otrocih in mladostnikih, ki se zdravijo z zaviralci TNF, ni mogoče izključiti tveganja za nastanek malignomov.
English: Simponi 50 mg given once a month, on the same date each month.
Slovenian: Zdravilo Simponi 50 mg dajemo enkrat na mesec, vsak mesec na isti datum.
English: • Do not pull back on the plunger at any time.
Slovenian: • Bata ne smete nikoli vleči nazaj.
English: Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter (see section 5.1).
Slovenian: Bolniki z ustreznim odzivom morajo v 6. tednu ter nato vsake 4 tedne prejeti odmerek 50 mg. Za bolnike z nezadostnim odzivom je morda bolj koristno, da nadaljujejo s prejemanjem odmerka 100 mg v 6. tednu in nato vsake 4 tedne (glejte poglavje 5.1).
English: If you do not respond well enough to these medicines, you may be given Simponi to:
Slovenian: Če se nanje ne boste dovolj dobro odzvali, pa vam bodo lahko predpisali zdravilo Simponi:
English: Ankylosing spondylitis and non-radiographic axial spondyloarthritis Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine.
Slovenian: Ankilozirajoči spondilitis in neradiografski aksialni spondiloartritis Ankilozirajoči spondilitis in neradiografski aksialni spondiloartritis sta vnetni bolezni hrbtenice.
English: In GO-AFTER, the primary endpoint was the percentage of patients achieving an ACR 20 response at week 14.
Slovenian: V študiji GO-AFTER je bil primarni opazovani dogodek odstotek bolnikov, ki so dosegli odziv ACR 20 v 14. tednu.
English: For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8).
Slovenian: Za vse zgoraj navedene indikacije pri bolnikih z RA, PsA, AS ali nr-aksialnim SpA s telesno maso več kot 100 kg, ki niso dosegli zadovoljivega kliničnega odziva na zdravljenje po 3 do 4 odmerkih, je potrebno premisliti, ali bi bilo umestno povečanje odmerka golimumaba na 100 mg enkrat na mesec.
English: Table 4 Key efficacy outcomes from GO-REVEAL
Slovenian: Preglednica 4 Ključni rezultati glede učinkovitosti iz študije GO-REVEAL
English: Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Slovenian: Zdravilo Simponi je v kombinaciji z metotreksatom (MTX) indicirano za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih, starih 2 leti ali več, ki se na predhodno zdravljenje z MTX niso odzvali zadostno.
English: • Low red blood cell counts
Slovenian: • majhno število rdečih krvnih celic,
English: Please contact your doctor or pharmacist for assistance.
Slovenian: Za pomoč se obrnite na zdravnika ali farmacevta.
English: What Simponi contains
Slovenian: Kaj vsebuje zdravilo Simponi
English: Subject/parent global assessment of overall well-being (VAS 0-10 cm) Number of active joints Number of joints with limited range of motion Physical function by CHAQ ESR (mm/h)
Slovenian: Splošna ocena počutja s strani bolnika ali staršev (VAS 0-10 cm) Število aktivno prizadetih sklepov Število sklepov z omejenim obsegom gibljivosti
English: Remove the cap (figure 4)
Slovenian: Snemite pokrovček (slika 4)
English: Result _______________
Slovenian: Rezultat _______________
English: Figure 10
Slovenian: Slika 10
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se pred uporabo zdravila Simponi posvetujte z zdravnikom ali farmacevtom.
English: Key results for the Simponi 50 mg dose at week 52 are presented in Table 5.
Slovenian: Ključni rezultati za uporabo zdravila Simponi v odmerku 50 mg v 52. tednu so predstavljeni v preglednici 5.
English: For the posology of the 50 mg dosing regimen, see section 4.2 of the Simponi 50 mg pre-filled pen or pre-filled syringe SmPC.
Slovenian: Za odmerjanje 50 mg odmerka glejte poglavje 4.2 v SmPC-ju za zdravilo Simponi 50 mg napolnjeni injekcijski peresnik ali napolnjena injekcijska brizga.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z drugimi zaviralci TNF, so v času trženja poročali o redkih primerih hepatospleničnega T-celičnega limfoma (HSTCL) (glejte poglavje 4.8).
English: CARTON FOR 1 PRE-FILLED SYRINGE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA ZA 1 NAPOLNJENO INJEKCIJSKO BRIZGO KOT VMESNA OVOJNINA/DEL VEČKRATNEGA PAKIRANJA (BREZ MODREGA OKENCA)
English: • If you cannot see the expiration date through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the expiration date to the viewing window.
Slovenian: • Če rok uporabnosti zdravila ni viden v okencu, držite napolnjeno injekcijsko brizgo za trup in obračajte pokrovček igle, da se bo položaj okenca poravnal z natisnjenim rokom uporabnosti zdravila.
English: Do not remove before instructed.
Slovenian: Pokrovček* Ne odstranite ga prej, kot je navedeno v navodilih.
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
Slovenian: Pri bolnikih, pri katerih ni nobenih znakov koristnega učinka zdravljenja niti po prejemu 3 do 4 dodatnih 100 mg odmerkov, pa je treba premisliti, ali je nadaljevanje zdravljenja sploh smiselno.
English: The incidence of serious infections per 100 subject-years of follow-up in the controlled period of RA, PsA, AS, and nr-Axial SpA trials was 7.3; 95% CI: 4.6, 11.1 for the golimumab 100 mg group, 2.9; 95% CI: 1.2, 6.0 for the golimumab 50 mg group and 3.6; 95% CI: 1.5, 7.0 for the placebo group.
Slovenian: Incidenca resnih okužb na 100 preiskovanec-let spremljanja je bila v kontroliranem obdobju preskušanj pri bolnikih z RA, PsA, AS in nr-aksialnim SpA 7,3; 95 % IZ: 4,6, 11,1 za skupino, ki je prejemala golimumab v odmerku 100 mg, 2,9; 95 % IZ: 1,2, 6,0 za skupino, ki je prejemala golimumab v odmerku 50 mg, in 3,6; 95 % IZ: 1,5, 7,0 za skupino, ki je prejemala placebo.
English: Inject within 5 minutes of removing the cap.
Slovenian: Injicirajte v 5 minutah po tem, ko ste odstranili pokrovček.
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-REVEAL) in 405 adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite non-steroidal anti-inflammatory (NSAID) or DMARD therapy.
Slovenian: Varnost in učinkovitost zdravila Simponi so ovrednotili v multicentrični, randomizirani, dvojno slepi in s placebom nadzorovani študiji (GO-REVEAL) pri 405 odraslih bolnikih z aktivnim PsA (z ≥ 3 oteklimi sklepi in ≥ 3 bolečimi sklepi) kljub prejemanju nesteroidnih antirevmatikov (NSAID) ali terapije DMARD.
English: • The recommended dose is 50 mg given once a month, on the same date each month.
Slovenian: • Priporočeni odmerek je 50 mg enkrat na mesec, vsak mesec na isti datum.
English: This medicine contains 18.45 mg sorbitol (E420) in each pre-filled pen.
Slovenian: To zdravilo vsebuje 18,45 mg sorbitola (E420) v enem napolnjenem injekcijskem peresniku.
English: • Scaly, peeling skin
Slovenian: • luskasta koža, luščenje kože,
English: A part of the pre-filled pen, the needle cover, contains latex.
Slovenian: Del napolnjenega injekcijskega peresnika, ščitnik igle, vsebuje lateks.
English: Patients were randomised to receive Simponi 50 mg, Simponi 100 mg or placebo administered subcutaneously every 4 weeks.
Slovenian: Bolnike so randomizirali tako, da so prejemali 50 mg zdravila Simponi, 100 mg zdravila Simponi ali placebo subkutano vsake 4 tedne.
English: When 50 mg golimumab was administered subcutaneously to patients with RA, PsA or AS every 4 weeks, serum concentrations reached steady state by week 12.
Slovenian: Ko so bolnikom z RA, PsA ali AS subkutano injicirali 50 mg golimumaba na vsake 4 tedne, so njegove serumske koncentracije dosegle stanje dinamičnega ravnovesja do 12. tedna.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen For paediatric patients below 40 kg golimumab
Slovenian: Simponi 45 mg/0,45 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Za pediatrične bolnike z manj kot 40 kg golimumab
English: Do not use Simponi if the solution is discoloured, cloudy or you can see foreign particles in it.
Slovenian: Zdravila Simponi ne smete uporabiti, če je raztopina obarvana, motna ali če so v njej vidni tuji delci.
English: 135 to < 145
Slovenian: 135 do < 145
English: In the controlled and uncontrolled periods of the pivotal trials with a median follow-up of up to 3 years, a greater incidence of demyelination was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg (see section 4.4).
Slovenian: V kontroliranih in nekontroliranih obdobjih ključnih preskušanj z medianim trajanjem spremljanja bolnikov do 3 let so opazili večjo incidenco demielinizirajočih bolezni pri bolnikih, ki so prejemali golimumab v odmerku 100 mg, kot pri bolnikih, ki so prejemali golimumab v odmerku 50 mg (glejte poglavje 4.4).
English: Key results for the 50 mg dose are shown in Table 5 and described below.
Slovenian: Bistveni rezultati za 50 mg odmerek so prikazani v Preglednici 5 in opisani v nadaljevanju.
English: The primary endpoint was the proportion of patients achieving ASAS 20 response at week 16.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov, ki so v 16. tednu dosegli odziv ASAS 20.
English: The efficacy of Simponi through week 54 was assessed in this study.
Slovenian: V tej študiji so ocenili učinkovitost zdravila Simponi do 54. tedna.
English: 165 to < 175
Slovenian: 165 do < 175
English: In the controlled and uncontrolled periods of the pivotal UC trials with a median follow-up of approximately 2 years, the proportion of patients with ALT elevations ≥ 5 x ULN was 0.8% 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 spremljanjem bolnikov približno 2 leti je bil delež bolnikov z zvišanji ALT na ≥ 5 x ZMN 0,8 % pri bolnikih, ki so med vzdrževalnim delom študije UK prejemali golimumab.
English: Among patients remaining in the study and treated with Simponi, improvements in physical function and health-related quality of life were similar from week 24 through week 256.
Slovenian: Med bolniki, ki so ostali v študiji in so bili zdravljeni z zdravilom Simponi, so podobno izboljšanje telesne funkcije in z zdravjem povezane kakovosti življenja opažali od 24. do 256. tedna.
English: • Do not touch this area again before giving the injection.
Slovenian: • Preden si date injekcijo, se tega mesta ne smete več dotakniti.
English: After removing the pre-filled pen from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi.
Slovenian: Ko bolnik vzame napolnjen injekcijski peresnik iz hladilnika, mora počakati 30 minut, preden si injicira zdravilo Simponi, da peresnik doseže sobno temperaturo.
English: Liquid will squirt out.
Slovenian: Takočina bo brizgnila ven.
English: Among 159 subjects randomised to Simponi 50 mg + MTX, 96 were still on this treatment at week 104.
Slovenian: Med 159 preiskovanci, ki so bili naključno razvrščeni v skupino, ki je prejemala zdravilo Simponi 50 mg z MTX, jih je bilo v 104. tednu 96 še vedno na tem zdravljenju.
English: 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
Slovenian: V študiji pJIA so otroci, ki so prejeli 30 mg/m2 (največ 50 mg) golimumaba subkutano vsake 4 tedne, dosegli mediane najnižje koncentracije golimumaba v stanju dinamičnega ravnovesja, ki so bile podobne v vseh starostnih skupinah in so bile prav tako podobne ali rahlo zvišane v primerjavi s koncentracijami pri odraslih bolnikih z RA, ki so prejeli 50 mg golimumaba vsake 4 tedne.
English: Patients entered an open label long-term extension at week 52.
Slovenian: V 52. tednu pa so bolnike vključili v podaljšek odprte dolgoročne študije.