FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent administration of TNF-antagonists and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Slovenian: V kliničnih študijah je bila sočasna uporaba antagonistov TNF in abatacepta v primerjavi z uporabo samih antagonistov TNF povezana s povečanim tveganjem za okužbe, vključno z resnimi okužbami, brez dodatne klinične koristi.
English: If you stop using Simponi If you are considering stopping Simponi, talk to your doctor or pharmacist first.
Slovenian: Če razmišljate, da bi prenehali uporabljati zdravilo Simponi, se najprej posvetujte z zdravnikom ali farmacevtom.
English: Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Slovenian: Če se pri bolniku pojavita nova resna okužba ali sepsa, je treba uporabo golimumaba prekiniti in uvesti ustrezno protimikrobno ali protiglivno terapijo, dokler okužba ni obvladana.
English: GO-FORWARD evaluated 444 patients who had active RA despite a stable dose of at least 15 mg/week of MTX and who had not been previously treated with an anti-TNF agent.
Slovenian: V študiji GO-FORWARD so ovrednotili 444 bolnikov, ki so imeli aktivni revmatoidni artritis kljub prejemanju stalnega odmerka MTX najmanj 15 mg/teden in pred tem niso bili zdravljeni z zaviralcem TNF.
English: For additional assistance refer to the Package Leaflet for your local representative contact information.
Slovenian: Za dodatno pomoč se obrnite na lokalno predstavništvo; kontaktne podatke najdete v navodilu za uporabo.
English: Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m2 body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month.
Slovenian: Poliartikularni juvenilni idiopatski artritis pri otrocih s telesne maso manj kot 40 kg Priporočeni odmerek zdravila Simponi za otroke s telesno maso manj kot 40 kg s poliartikularnim juvenilnim idiopatskim artritisom je 30 mg/m2 telesne površine do največjega enkratnega odmerka
English: Uncommon: Arrhythmia, ischemic coronary artery disorders Rare: Congestive heart failure (new onset or worsening)
Slovenian: Občasni: aritmija, ishemična bolezen koronarnih arterij Redki: kongestivno srčno popuščanje (novonastalo ali poslabšanje obstoječega)
English: At week 16, 34% of children had inactive disease defined as having the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalised lymphadenopathy attributable to JIA; no active uveitis; normal ESR (< 20 mm/hour) or CRP (< 1.0 mg/dL); physician global assessment of disease activity (≤ 5 mm on the VAS); duration of morning stiffness < 15 minutes.
Slovenian: V 16. tednu je imelo 34 % otrok neaktivno bolezen, kar je pomenilo, da je zanje veljalo vse od naštetega v nadaljevanju: odsotnost sklepov z aktivnim artritisom; odsotnost zvišane telesne temperature, izpuščajev, serozitisa, splenomegalije, hepatomegalije ali generalizirane limfadenopatije, povezane z JIA; brez aktivnega uveitisa; normalne vrednosti ESR (< 20 mm/uro) ali CRP (< 1,0 mg/dl); splošna ocena aktivnosti bolezni s strani zdravnika (≤ 5 mm glede na VAS); trajanje jutranje okorelosti < 15 minut.
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports that the dosing regimen of golimumab 50 mg every 4 weeks in children with pJIA of at least 40 kg achieves similar exposures to those shown to be efficacious in adults.
Slovenian: Modeliranje in simulacija populacijske farmakokinetike/farmakodinamike pri otrocih s pJIA sta potrdila zvezo med serumsko izpostavljenostjo golimumabu in klinično učinkovitostjo ter dokazujeta, da pri otrocih s pJIA, ki so težki najmanj 40 kg, režim odmerjanja 50 mg golimumaba vsake 4 tedne dosega podobne izpostavljenosti tistim, ki so se pokazale kot učinkovite pri odraslih.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab.
Slovenian: Bolnike je treba pred, med in po zdravljenju z golimumabom natančno spremljati glede okužb, vključno s tuberkulozo.
English: It is important that the right strength is used to administer the correct dose as indicated in the posology (see section 4.2).
Slovenian: Za aplikacijo pravilnega odmerka je pomembno, da uporabite pravo jakost, kot je navedeno v poglavju o odmerjanju (glejte poglavje 4.2).
English: Among 146 patients randomised to Simponi 50 mg, 70 were still on this treatment at week 104.
Slovenian: Od 146 bolnikov, ki so bili naključno razvrščeni v skupino za prejemanje zdravila Simponi v odmerku 50 mg, jih je bilo v 104. tednu 70 še vedno na tem zdravljenju.
English: Concurrent administration with other biological therapeutics There is insufficient information regarding the concomitant use of golimumab with other biological therapeutics used to treat the same conditions as golimumab.
Slovenian: Na voljo ni zadostnih podatkov o sočasni uporabi golimumaba z drugimi biološkimi zdravili, ki se uporabljajo za zdravljenje enakih bolezni, kot jih zdravimo z golimumabom.
English: Table 2 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Slovenian: Preglednica 2 Ključni rezultati glede učinkovitosti iz nadzorovanih delov študij GO-FORWARD, GO-AFTER in GO-BEFORE
English: • Infection of the joints or the tissue around them
Slovenian: • okužba sklepov ali okoliških tkiv,
English: • if the dose is more than 2 weeks late, the patient should inject the forgotten dose and a new schedule should be established from the date of this injection.
Slovenian: • če je bolnik zamudil z odmerkom več kot 2 tedna, si mora injicirati pozabljeni odmerek in od datuma te injekcije naprej uvesti nov režim odmerjanja.
English: Check the number of pre-filled syringes Check the pre-filled syringes to make sure
Slovenian: Preverite število napolnjenih injekcijskih brizg Preverite napolnjene injekcijske brizge, da se prepričate,
English: Golimumab should be used with caution in subjects with impaired hepatic function (see section 4.2).
Slovenian: Golimumab je treba uporabljati previdno pri bolnikih, ki imajo okvarjeno delovanje jeter (glejte poglavje 4.2).
English: Improvements in key measures of disease activity were observed at the first assessment (week 4) after the initial Simponi administration and were maintained through week 24.
Slovenian: Izboljšanje bistvenih meril aktivnosti bolezni so opazili že ob prvi oceni (v 4. tednu) po prvi uporabi zdravila Simponi in se je ohranjalo v času do 24. tedna.
English: In an exploratory clinical trial evaluating the use of golimumab in patients with severe persistent asthma, more malignancies were reported in patients treated with golimumab compared with control patients (see section 4.8).
Slovenian: V eksploratornem kliničnem preskušanju za oceno uporabe golimumaba pri bolnikih s hudo trdovratno astmo so pri bolnikih, zdravljenih z golimumabom, poročali o večjem številu malignomov kot pri tistih iz kontrolne skupine (glejte poglavje 4.8).
English: • For patients weighing at least 40 kg, the recommended dose is 50 mg given once a month, on the same date each month.
Slovenian: • Za bolnike, ki tehtajo vsaj 40 kg, je priporočeni odmerek 50 mg enkrat na mesec, vsak mesec na isti datum.
English: Percentage of patients Maintenance of response (Patients in clinical response through week 54) Sustained remission (Patients in clinical remission at both week 30 and week 54)
Slovenian: Trajna remisija (bolniki v klinični remisiji tako v 30. tednu kot v 54. tednu)
English: These changes were observed at the first assessment (week 4) after the initial Simponi administration and were generally maintained through week 24.
Slovenian: Te spremembe so opazili ob prvi oceni stanja (v 4. tednu) po prvem prejemu zdravila Simponi in so se običajno ohranjale do 24. tedna.
English: • Inflamed eye (conjunctivitis)
Slovenian: • vnetje očesne veznice (konjunktivitis),
English: Choose different sites for these injections and give the injections one right after the other.
Slovenian: Izberite različna mesta za injiciranje in si injicirajte injekcije eno za drugo.
English: • Talk to your doctor or pharmacist if the yellow indicator is not visible in the window or if you suspect that you may not have received a complete dose.
Slovenian: • Če v okencu ni viden rumeni kazalnik ali če sumite, da morda niste prejeli celotnega odmerka,
English: GO-BEFORE evaluated 637 patients with active RA who were MTX-naïve and had not previously been treated with an anti-TNF agent.
Slovenian: V študiji GO-BEFORE so ovrednotili 637 bolnikov z aktivnim revmatoidnim artritisom, ki še niso prejemali MTX in pred tem niso bili zdravljeni z zdravilom proti TNF.
English: Dizziness may however occur following administration of Simponi (see section 4.8).
Slovenian: Med uporabo zdravila Simponi se lahko vseeno pojavi omotica (glejte poglavje 4.8).
English: Following a single SC dose in healthy subjects, approximately dose-proportional pharmacokinetics were also observed over a dose range of 50 mg to 400 mg.
Slovenian: Po enkratnem subkutanem odmerku so pri zdravih preiskovancih v razponu odmerkov od 50 mg do 400 mg opažali približno odmerku sorazmerno farmakokinetiko.
English: Treatment with concomitant immunomodulators (azathioprine, 6-mercaptopurine and MTX) resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without immunomodulators (1% (4/308) versus 3% (22/638), respectively).
Slovenian: Sočasno zdravljenje z imunomodulatorji (azatioprinom, 6-merkaptopurinom in MTX) je vodilo do manjšega odstotka bolnikov s protitelesi proti golimumabu v primerjavi z bolniki, ki so prejemali golimumab brez imunomodulatorjev (1 % (4/308) v primerjavi s 3 % (22/638)).
English: Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Slovenian: Če ste pred kratkim prejeli ali boste prejeli povzročitelje okužb v terapevtske namene (kot je uporaba BCG za zdravljenje raka), se posvetujte z zdravnikom.
English: • Talk to your doctor before you take the fourth dose.
Slovenian: • Pred četrtim odmerkom se posvetujte z zdravnikom.
English: • 1 Cotton ball or gauze pad
Slovenian: • 1 kosem vate ali zloženec gaze
English: Call your doctor or pharmacist for a new pre-filled pen.
Slovenian: Obrnite se na zdravnika ali farmacevta, da boste dobili nov napolnjen injekcijski peresnik.
English: 16% 31% p = 0.002 49% 62% Week 52 NA NA NA
Slovenian: 16 % 31 % p = 0,002 49 % 62 %
English: Excipients: sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: sorbitol (E420), histidin, histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.
English: During the placebo-controlled portion of the study, the incidence (95% CI) of all malignancies per 100 subject-years of follow-up was 3.19 (1.38, 6.28) in the golimumab group.
Slovenian: Med s placebom kontroliranim delom te študije je bila incidenca (95 % IZ) vseh malignomov na 100 preiskovanec-let spremljanja v skupini, ki je prejemala golimumab, 3,19 (1,38, 6,28).
English: Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Slovenian: Uporaba zdravila Simponi v kombinaciji z MTX je pokazala zmanjšanje hitrosti napredovanja okvare sklepov, kar so merili z rentgenskim slikanjem, in izboljšanje delovanja sklepov.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after golimumab treatment.
Slovenian: Vse bolnike je treba opozoriti, naj poiščejo zdravniško pomoč, če se med ali po zdravljenju z golimumabom pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. dolgotrajen kašelj, hujšanje/izguba telesne mase, nekoliko zvišana telesna temperatura).
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible.
Slovenian: Če je mogoče, se je pri teh bolnikih treba o diagnozi in empiričnem protiglivnem zdravljenju posvetovati z zdravnikom, ki ima izkušnje z zdravljenjem bolnikov z invazivnimi glivnimi okužbami.
English: • Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
Slovenian: • reakcije na mestu injiciranja (vključno s pordelostjo, zatrdlino, bolečino, podplutbo, srbenjem,
English: • Combined low platelet, red, and white blood cell count
Slovenian: • majhno skupno število trombocitov, rdečih in belih krvnih celic,
English: • Check the security seal around the cap of the pre-filled pen.
Slovenian: • Preverite varnostni pečat okoli pokrovčka napolnjenega injekcijskega peresnika.
English: How much Simponi is given Polyarticular juvenile idiopathic arthritis in children 2 years of age and older:
Slovenian: Koliko zdravila Simponi uporabimo Poliartikularni juvenilni idiopatski artritis pri otrocih, starih 2 leti ali več:
English: Treatment with concomitant MTX resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without MTX (approximately 3% [41/1235] versus 8% [64/827], respectively).
Slovenian: Sočasno zdravljenje z MTX je vodilo do manjšega odstotka bolnikov s protitelesi proti golimumabu v primerjavi z bolniki, ki so prejemali golimumab brez MTX (približno 3 % [41/1235] v primerjavi z 8 % [64/827]).
English: Table 4 Key efficacy outcomes from the controlled portions of GO-FORWARD, GO-AFTER and GO-BEFORE.
Slovenian: Preglednica 4 Ključni rezultati glede učinkovitosti iz nadzorovanih delov študij GO-FORWARD, GO-AFTER in GO-BEFORE
English: • Manually press the plunger to inject, like a syringe
Slovenian: • ročno pritisniti bat za injiciranje, tako kot pri injekcijski brizgi.
English: Patients treated with Simponi should be given the Patient Reminder Card which is included in the pack.
Slovenian: Bolniki, ki se zdravijo z zdravilom Simponi, morajo dobiti opozorilno kartico za bolnika, ki je priložena v pakiranju.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (pri temperaturi med 2 °C in 8 °C).
English: If you have ulcerative colitis you will first be given other medicines.
Slovenian: Če imate ulcerozni kolitis, boste najprej prejeli druga zdravila.
English: GO-BEFORE Active RA, MTX Naïve
Slovenian: GO-BEFORE aktiven RA, predhodno še nezdravljen z MTX
English: The proportion of patients who eliminated corticosteroids by week 54 was greater in the 50 mg group (41%, 32/78) and 100 mg group (33%, 27/82) compared with the placebo group (22%, 19/87).
Slovenian: Delež bolnikov, ki do 54. tedna niso več uporabljali kortikosteroidov, je bil večji v skupini s 50 mg (41 %, 32/78) in v skupini s 100 mg (33 %, 27/82) kot v skupini, ki je prejemala placebo (22 %, 19/87).
English: The active substance is golimumab.
Slovenian: Učinkovina je golimumab.
English: In these studies, Simponi demonstrated clinically meaningful and statistically significant improvement in HAQ DI from baseline versus control at week 24.
Slovenian: V teh študijah so z zdravilom Simponi dosegli klinično pomembno in statistično značilno izboljšanje rezultata HAQ DI glede na začetek študije v primerjavi s kontrolno skupino v 24. tednu.
English: * p ≤ 0.001 for all comparisons n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Slovenian: * p ≤ 0,001 za vse primerjave n odraža število randomiziranih bolnikov; dejansko število bolnikov, ki jih je bilo mogoče oceniti za vsak končni rezultat, pa se lahko razlikuje med časovnimi točkami
English: In UC patients treated with 50 mg or 100 mg golimumab subcutaneously every 4 weeks, concomitant use of immunomodulators did not have a substantial effect on steady-state trough levels of golimumab.
Slovenian: Pri bolnikih z UK, ki so prejemali 50 mg ali 100 mg golimumaba subkutano vsake 4 tedne, sočasna uporaba imunomodulatorjev ni bistveno vplivala na najnižjo koncentracijo golimumaba v stanju dinamičnega ravnovesja.
English: Excipient with known effect Each pre-filled pen contains 18.45 mg sorbitol (E420) per 45 mg dose.
Slovenian: Pomožna snov z znanim učinkom: En napolnjen injekcijski peresnik vsebuje 18,45 mg sorbitola (E420) na 45 mg odmerek.
English: Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Slovenian: Simptomi alergijske reakcije lahko vključujejo otekanje obraza, ustnic, ust ali žrela, kar lahko povzroči težave pri požiranju ali dihanju, kožni izpuščaj, koprivnico, otekanje dlani, stopal ali gležnjev.
English: • On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers.
Slovenian: • V redkih primerih so pri bolnikih, ki so jemali druge zaviralce TNF, opazili določeno in hudo vrsto limfoma, imenovanega jetrnovranični T-celični limfom.
English: Table 8 Improvements from baseline in ACR Ped components at week 16 Median percent improvement Simponi 30 mg/m b = 173
Slovenian: Preglednica 8 Izboljšanje komponent ACR Ped glede na izhodiščno vrednost v 16. tednu Mediani odstotek izboljšanja Simponi 30 mg/m b = 173
English: The primary endpoint was the percentage of patients achieving Ankylosing Spondylitis Assessment Study Group (ASAS) 20 response at week 14.
Slovenian: Primarni končni rezultat je bil odstotek bolnikov, ki so dosegli odziv ASAS 20 na lestvici študijske skupine za oceno ankilozirajočega spondilitisa (Ankylosing Spondylitis Assessment Study Group - ASAS) v 14. tednu.
English: Sorbitol intolerance
Slovenian: Neprenašanje sorbitola
English: Statistically significant responses in BASDAI 50, 70 and 90 (p ≤ 0.017) were also seen at weeks 14 and 24.
Slovenian: V 14. in 24. tednu so opazili tudi statistično značilne odzive glede BASDAI 50, 70 in 90 (p ≤ 0,017).
English: • Do not rub your skin.
Slovenian: • Kože ne smete drgniti.
English: • There have been cases of cancers, including unusual types, in children and teenage patients taking TNF-blocking agents, which sometimes resulted in death.
Slovenian: • Pri otrocih in najstnikih, ki so prejemali zaviralce TNF, so se pojavili primeri raka, vključno z neobičajnimi vrstami raka, ki so se v nekaterih primerih končali s smrtnim izidom.
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1.
Slovenian: Neželeni učinki, ki so jih opazili v kliničnih študijah in pri uporabi golimumaba v obdobju trženja po vsem svetu, so navedeni v Preglednici 1.
English: • Look at the liquid through the viewing window of the pre-filled syringe and make sure that it is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow.
Slovenian: • Poglejte skozi opazovalno okence v napolnjeni injekcijski brizgi in se prepričajte, da je tekočina v njej bistra do rahlo opalescentna (tj. da ima biserni sij) ter brezbarvna do svetlo rumena.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly, hard or has scars or stretch marks.
Slovenian: • Zdravila si ne injicirajte v predele, kjer je koža občutljiva, podpluta, pordela, luskasta ali zatrdela oziroma, kjer so vidne brazgotine ali strije.
English: At week 52, 15% of patients in the Simponi 50 mg + MTX group achieved a major clinical response compared with 7% of patients in the placebo + MTX group (p = 0.018).
Slovenian: V 52. tednu je v skupini, ki je prejemala zdravilo Simponi 50 mg z MTX, 15 % bolnikov doseglo velik klinični odziv, v primerjavi s samo 7 % bolnikov iz skupine, ki je prejemala placebo z MTX (p = 0,018).
English: * p < 0.05 for all comparisons; n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint
Slovenian: * p < 0,05 za vse primerjave n odraža število randomiziranih bolnikov; dejansko število bolnikov, ki jih je bilo mogoče oceniti za vsak končni rezultat, pa se lahko razlikuje med časovnimi točkami
English: • Wait 30 minutes to allow the product to reach room temperature
Slovenian: • Počakajte 30 minut, da zdravilo doseže sobno temperaturo.
English: A part of the pre-filled syringe, the needle cover, contains latex.
Slovenian: Del napolnjene injekcijske brizge, ščitnik igle, vsebuje lateks.
English: At week 48, 53% and 55% of children in the Simponi + MTX group and placebo + MTX group, respectively, were ACR Ped 30 responders, and 40% and 28% of children in the Simponi + MTX group and placebo + MTX group, respectively, achieved inactive disease.
Slovenian: V 48. tednu je 53 % otrok iz skupine, ki je prejemala zdravilo Simponi in MTX, in 55 % otrok iz skupine, ki je prejemala placebo in MTX, doseglo odziv ACR Ped 30; 40 % otrok iz skupine, ki je prejemala zdravilo Simponi in MTX, in 28 % otrok iz skupine, ki je prejemala placebo in MTX, je doseglo neaktivno bolezen.
English: A subcutaneous injection of 50 mg golimumab to healthy subjects produced a mean  standard deviation maximum serum concentration (Cmax) of 3.1  1.4 g/mL.
Slovenian: S subkutanim injiciranjem 50 mg golimumaba zdravim preiskovancem so dosegli srednjo vrednost ± standardno deviacijo največje serumske koncentracije zdravila (Cmax) 3,1 ± 1,4 g/ml.
English: It is important that the correct dose is administered as indicated in the posology (see section 4.2).
Slovenian: Pomembno je, da uporabite pravo jakost, kot je navedeno v poglavju o odmerjanju (glejte poglavje 4.2).
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-AHEAD) in 197 adult patients with severe active nr-Axial SpA (defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS).
Slovenian: Varnost in učinkovitost zdravila Simponi so ocenili v multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani študiji (GO-AHEAD) pri 197 odraslih bolnikih s hudim aktivnim nr-aksialnim SpA (opredeljenih kot tisti bolniki, ki so izpolnjevali razvrstitvena merila ASAS za aksialni spondiloartritis, vendar niso izpolnjevali modificiranih newyorških meril za AS).
English: • Do not touch the needle guard activation clips (as indicated by asterisks * in figure 1) to prevent prematurely covering the needle with the needle guard.
Slovenian: • Ne dotikajte se aktivacijskih nastavkov za ščitnik igle (ki sta označena z zvezdico * na sliki 1),
English: Care should be taken to ensure that patients are not underdosed or overdosed.
Slovenian: Poskrbeti je treba, da bolniki ne dobijo premajhnega ali prevelikega odmerka.