FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a single subcutaneous administration of golimumab to healthy subjects or patients with RA, the median time to reach maximum serum concentrations (Tmax) ranged from 2 to 6 days.
Slovenian: Po enkratnem subkutanem injiciranju golimumaba zdravim preiskovancem ali bolnikom z revmatoidnim artritisom je bila mediana vrednost časa do dosega največje serumske koncentracije zdravila (tmax) od 2 do 6 dni.
English: At week 52, patients entered an open label long-term extension.
Slovenian: V 52. tednu pa so ti bolniki vstopili v odprto, dolgoročno podaljšanje študije.
English: In patients weighing less than 80 kg, a greater proportion of patients who received 50 mg maintenance therapy showed sustained clinical remission compared with those who received placebo.
Slovenian: Med bolniki, lažjimi od 80 kg, je imel trajno klinično remisijo večji delež tistih bolnikov, ki so prejemali vzdrževalno zdravljenje s 50 mg, kot bolnikov, ki so prejemali placebo.
English: Structural damage in both hands and feet was assessed radiographically by the change from baseline in the vdH-S score, modified for PsA by addition of hand distal interphalangeal (DIP) joints.
Slovenian: Strukturne okvare v obojem - v dlaneh in stopalih - so ocenjevali z rentgenskim slikanjem na podlagi sprememb v oceni vdH-S, prilagojeni za PsA z dodatkom distalnih interfalangealnih sklepov roke, v primerjavi z začetnimi vrednostmi.
English: • If multiple injections are required for a single administration, the injections should be administered at different sites on the body.
Slovenian: • Če si morate zdravilo injicirati večkrat, je treba posamezne injekcije uporabiti na različnih mestih na telesu.
English: • Check the expiration date (as indicated by “EXP”) on the label by looking through the viewing window located within the body of the pre-filled syringe.
Slovenian: • Preverite rok uporabnosti zdravila (označeno z “EXP”) na nalepki, tako da pogledate skozi opazovalno okence, ki se nahaja na trupu napolnjene injekcijske brizge.
English: • Narrowing of the blood vessels in the heart
Slovenian: • zoženje krvnih žil v srcu,
English: • Do not use this medicine if you notice that the liquid is not a clear to light yellow colour, cloudy, or contains foreign particles.
Slovenian: • Ne uporabljajte tega zdravila, če opazite, da tekočina ni bistra do svetlo rumena, če je motna ali vsebuje tuje delce.
English: There is limited safety experience of golimumab treatment in patients who have undergone surgical procedures, including arthroplasty.
Slovenian: Izkušnje glede varnosti zdravljenja z golimumabom pri bolnikih, ki so imeli kirurški poseg, vključno z artroplastiko, so omejene.
English: Golimumab exhibited approximately dose-proportional pharmacokinetics in patients with RA over the dose range of 0.1 to 10.0 mg/kg following a single intravenous dose.
Slovenian: Pri bolnikih z RA se je pri golimumabu pokazala približno odmerku sorazmerna farmakokinetika v razponu od 0,1 do 10,0 mg/kg po enkratnem intravenskem odmerku zdravila.
English: Eighty-two percent (18/22) of antibody-positive patients had neutralising antibodies in vitro.
Slovenian: Dvainosemdeset odstotkov (18/22) bolnikov s pozitivnim izvidom na protitelesa je imelo in vitro nevtralizirajoča protitelesa.
English: There was a trend toward higher apparent clearance of golimumab with increasing weight (see section 4.2).
Slovenian: Pokazala se je tendenca k naraščanju navideznega očistka golimumaba pri naraščajoči telesni masi bolnika (glejte poglavje 4.2).
English: • Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
Slovenian: • rakava obolenja, vključno z rakom kože in nerakavimi raščami ali bulami, vključno s kožnimi znamenji,
English: For placebo subjects, the incidence (95% CI) per 100 subject-years of follow-up of these malignancies was 0.00 (0.00, 2.94).
Slovenian: Pri preiskovancih, ki so prejemali placebo, pa je bila incidenca (95 % IZ) na 100 preiskovanec-let spremljanja teh malignomov 0,00 (0,00, 2,94).
English: The incidence of lymphoma in golimumab-treated patients during the pivotal trials was higher than expected in the general population.
Slovenian: Incidenca limfoma je bila v ključnih preskušanjih pri bolnikih zdravljenih z golimumabom večja od pričakovane za splošno populacijo.
English: • Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever
Slovenian: • bolezni želodca in črevesja, ki vključujejo vnetje želodčne sluznice in debelega črevesa, kar lahko povzroči zvišano telesno temperaturo,
English: The efficacy of Simponi was demonstrated in three multi-centre, randomised, double-blind, placebo-controlled studies in over 1500 patients ≥ 18 years of age with moderately to severely active RA diagnosed according to American College of Rheumatology (ACR) criteria for at least 3 months prior to screening.
Slovenian: Učinkovitost zdravila Simponi so dokazali v treh multicentričnih, randomiziranih, dvojno slepih in s placebom nadzorovanim študijah pri 1.500 bolnikih, starih ≥ 18 let, ki so jim postavili diagnozo zmerno do močno aktivnega revmatoidnega artritisa po kriterijih Ameriškega združenja za revmatologijo (American College of Rheumatology - ACR) najmanj 3 mesece pred presejalnim pregledom.
English: At week 52, patients entered an open label long-term extension in which patients receiving placebo + MTX who had at least 1 tender or swollen joint were switched to Simponi 50 mg + MTX.
Slovenian: V 52. tednu so bolnike vključili v odprto, dolgoročno podaljšanje študije, v katerem so pri bolnikih, ki so prejemali placebo in MTX in so imeli najmanj en boleč ali otekel sklep, prešli na prejemanje zdravila Simponi 50 mg in MTX.
English: In children 2 years of age and older, Simponi is used for the treatment of polyarticular juvenile idiopathic arthritis.
Slovenian: Pri otrocih, starih 2 leti ali več, se zdravilo Simponi uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa.
English: Golimumab crosses the placenta.
Slovenian: Golimumab prehaja skozi placento.
English: • At the start, your doctor or nurse may inject Simponi.
Slovenian: • Sprva vam bo zdravilo Simponi lahko injiciral zdravnik ali medicinska sestra.
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see figure 8).
Slovenian: • Z batom potisnjenim noter do konca še naprej ohranite pritisk na glavo bata in ob tem iztaknite iglo iz kože ter spustite kožno gubo (glejte sliko 8).
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports the dosing regimen of golimumab 30 mg/m2 every 4 weeks in children with pJIA.
Slovenian: Modeliranje in simulacija populacijske farmakokinetike/farmakodinamike pri otrocih s pJIA sta potrdila zvezo med serumsko izpostavljenostjo golimumabu in klinično učinkovitostjo ter pri otrocih s pJIA podpirata režim odmerjanja 30 mg/m2 golimumaba vsake 4 tedne.
English: If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.
Slovenian: Če boste odstranili napolnjeni injekcijski peresnik, mogoče ne boste prejeli celotnega odmerka zdravila.
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 polyarticular juvenile idiopathic arthritis.
Slovenian: • Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo, vključno s katerim koli drugim zdravilom za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa.
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Slovenian: V eksploratornem kliničnem preskušanju za oceno uporabe drugega zaviralca TNF, infliksimaba, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB) so poročali o večjem številu malignomov, večinoma v predelu pljuč ter glave in vratu, pri bolnikih, ki so bili zdravljeni z infliksimabom, v primerjavi s tistimi iz kontrolne skupine.
English: Pregnancy and breast-feeding Talk to your doctor before using Simponi if:
Slovenian: Nosečnost in dojenje Pred uporabo zdravila Simponi se posvetujte z zdravnikom:
English: Simponi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Simponi je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se nezadostno odzvali na običajno zdravljenje, vključno s kortikosteroidi in 6-merkaptopurinom (6-MP) ali azatioprinom (AZA), in tistih, ki takšnega zdravljenja ne prenesejo ali imajo zanj medicinske kontraindikacije.
English: The needle cover on the pre-filled pen or the pre-filled syringe is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Slovenian: Ščitnik igle na napolnjenem injekcijskem peresniku ali napolnjeni injekcijski brizgi je izdelan iz suhe naravne gume, ki vsebuje lateks, in lahko povzroča alergijske reakcije pri posameznikih, ki so občutljivi za lateks.
English: • This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton.
Slovenian: • To zdravilo se lahko shranjuje tudi izven hladilnika 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: • You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
Slovenian: • Na mesto injiciranja lahko pritisnete kosem vate ali gazo in jo držite 10 sekund.
English: Patients should be instructed to inject the full amount of Simponi according to the comprehensive instructions for use provided in the package leaflet.
Slovenian: Bolnikom je treba naročiti, naj si injicirajo celotno količino zdravila Simponi v skladu z obsežnimi navodili za uporabo, ki so na voljo v navodilu za uporabo.
English: Of patients that continued in the study extension and had evaluable samples through week 228, antibodies to golimumab were detected in 4% (23/604) of golimumab treated patients.
Slovenian: Med bolniki, ki so bili vključeni v podaljšanje študije in so imeli do 228. tedna vzorce, primerne za analizo, so protitelesa proti golimumabu ugotovili pri 4 % (23/604) bolnikov, zdravljenih z golimumabom.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Slovenian: Pri otrocih, mladostnikih in mlajših odraslih (do 22 leta starosti), ki so se zdravili z zaviralci TNF (začetek zdravljenja je bil pri starosti ≤ 18 let), so v času trženja zdravila poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
English: In vitro, TNF-induced secretion of interleukin (IL)-6, IL-8 and granulocyte-macrophage colony stimulating factor (GM-CSF) by human endothelial cells was also inhibited by golimumab.
Slovenian: In vitro pa golimumab zavira tudi s TNF sproženo sekrecijo interlevkina (IL)-6, IL-8 in spodbujevalnega faktorja za granulocitno-makrofagne kolonije (GM-CSF) iz človeških endotelijskih celic.
English: • On rare occasions, people treated with TNF blockers have developed lupus.
Slovenian: • V redkih primerih se je pri osebah, zdravljenih z zaviralci TNF, pojavil lupus.
English: • Balance disorders
Slovenian: • motnje ravnotežja,
English: After disease flare, children received Simponi 30 mg/m2 (maximum 50 mg) + MTX.
Slovenian: Po ponovnem zagonu bolezni so otroci prejeli 30 mg/m2 (največ 50 mg) zdravila Simponi in MTX.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of golimumab.
Slovenian: Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in negativen test na latentno tuberkulozo, je treba pred uvedbo zdravljenja z golimumabom premisliti o uvedbi protituberkulozne terapije.
English: Patients with body weight greater than 100 kg
Slovenian: Bolniki s telesno maso več kot 100 kg
English: In the dose confirming portion of the study, 761 patients were randomised to receive either 400 mg Simponi SC at week 0 and 200 mg at week 2, 200 mg Simponi SC at week 0 and 100 mg at week 2, or placebo SC at weeks 0 and 2.
Slovenian: V delu študije, namenjenemu potrditvi odmerka, so 761 bolnikov randomizirali na eno od treh shem: 400 mg zdravila Simponi subkutano v tednu 0 in 200 mg v 2. tednu, 200 mg zdravila Simponi subkutano v tednu 0 in 100 mg v 2. tednu ali placebo subkutano v tednih 0 in 2.
English: If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Slovenian: Če ste negotovi, se obrnite na zdravnika ali farmacevta, da boste dobili nov napolnjen injekcijski peresnik.
English: Table 5 Key efficacy outcomes from GO-RAISE.
Slovenian: Preglednica 5 Ključni rezultati glede učinkovitosti iz študije GO-RAISE
English: A patient had to be in remission at both weeks 30 and 54 (without demonstrating a loss of response at any time point through week 54) to achieve durable remission.
Slovenian: Da je bolnik dosegel trajno remisijo, je moral biti v remisiji tako v 30. tednu kot v 54. tednu (in brez izginotja odziva kadar koli do 54. tedna).
English: • Inject all of the medicine by pushing in the plunger until the plunger head is completely between the needle guard wings (see figure 7).
Slovenian: • Vbrizgajte vso količino zdravila s pritiskom bata noter, da boste glavo bata potisnili vse do predela med krilci ščitnika igle (glejte sliko 7).
English: Care should be taken to provide the right strength to ensure that patients are not underdosed or overdosed.
Slovenian: Previdnost je potrebna pri izbiri prave jakosti, da bolniki ne dobijo premajhnega ali prevelikega odmerka.
English: The new expiry date must be written on the carton (up to 30 days from the date removed from the refrigerator).
Slovenian: Novi datum izteka roka uporabnosti je treba napisati na škatlo (do 30 dni od dne, ko se zdravilo vzame iz hladilnika).
English: • If you cannot see the liquid through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the liquid to the viewing window (see figure 2).
Slovenian: • Če skozi okence ne morete videti tekočine, držite napolnjeno injekcijsko brizgo za trup in obračajte pokrovček igle, da se bo položaj okenca poravnal s tekočino (glejte sliko 2).
English: Gently, press the plunger up with your thumb until it stops.
Slovenian: S palcem nežno pritisnite bat navzgor, dokler se ne ustavi.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions (see section 4.4).
Slovenian: Prisotnost protiteles proti golimumabu lahko poveča možnost za reakcijo na mestu vboda (glejte poglavje 4.4).
English: Use a cotton ball or gauze
Slovenian: Uporabite kosem vate ali gazo
English: Dose selections: 0.1 mL
Slovenian: Nastavitve odmerka: 0,1 ml
English: In the Phase III studies in RA, PsA, AS, and UC, no overall differences in adverse events (AEs), serious adverse events (SAEs), and serious infections in patients age 65 or older who received golimumab were observed compared with younger patients.
Slovenian: V študijah faze III pri bolnikih z RA, PsA, AS in UK na splošno niso opazili nobenih razlik v neželenih učinkih (NU), resnih neželenih učinkih (RNU) in resnih okužbah pri bolnikih, starih 65 let ali več, ki so prejemali golimumab, v primerjavi z mlajšimi bolniki.
English: Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive Rare: Serious systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (systemic), sarcoidosis
Slovenian: Pogosti: alergijske reakcije (bronhospazem, preobčutljivost, urtikarija), pozitiven izvid na avtoprotitelesa Redki: resne sistemske preobčutljivostne reakcije (vključno z anafilaktično reakcijo), vaskulitis (sistemski), sarkoidoza
English: • The cap should not be removed until you are ready to inject the medicine.
Slovenian: • Pokrovčka ne smete sneti, dokler niste pripravljeni za injiciranje zdravila.
English: If you forget to use Simponi If you forget to use Simponi on your planned date, inject the forgotten dose as soon as you remember.
Slovenian: Če ste pozabili uporabiti zdravilo Simponi na predvideni datum, si pozabljeni odmerek injicirajte takoj, ko se spomnite.
English: Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity.
Slovenian: V klinični študiji so bolniki prejeli enkratne intravenske odmerke do 10 mg/kg in ni prišlo do toksičnosti, ki bi omejevala odmerek.
English: Responders, % of patients ACR 20
Slovenian: Bolniki, ki so se odzvali na zdravljenje, % bolnikov ACR 20
English: The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections.
Slovenian: Druge sestavine zdravila so sorbitol (E420), histidin, histidinijev klorid monohidrat, polisorbat 80 in voda za injekcije.
English: Your doctor will decide if you should receive Simponi.
Slovenian: Zdravnik bo presodil, ali lahko prejmete zdravilo Simponi.
English: Distribution Following a single IV administration, the mean volume of distribution was 115  19 mL/kg.
Slovenian: Po enkratnem intravenskem odmerku zdravila je bila vrednost njegovega srednjega porazdelitvenega volumna 115 ± 19 ml/kg.
English: The number of patients with no new erosions or a change from baseline in total vdH-S Score ≤ 0 was significantly higher in the Simponi treatment group than in the control group (p = 0.003).
Slovenian: Število bolnikov brez novih erozij ali s spremembo glede na začetne vrednosti skupnega rezultata vdH-S ≤ 0 je bilo statistično značilno večje pri skupini bolnikov, zdravljenih z zdravilom Simponi, kot pa v kontrolni skupini (p = 0,003).
English: A patient who requires surgery while on golimumab should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnike, ki potrebujejo kirurški poseg med zdravljenjem z golimumabom, je treba skrbno spremljati glede morebitnih okužb ter sprejeti ustrezne ukrepe.
English: Can be stored at room temperature (up to 25°C) for a single period up to 30 days, but not exceeding the original expiry date.
Slovenian: Lahko se shranjuje pri sobni temperaturi (do 25 °C) za enkratno obdobje do 30 dni, vendar ne dlje od prvotnega datuma izteka roka uporabnosti.
English: • Place the needle at approximately a 45-degree angle to the pinched skin.
Slovenian: • Iglo postavite na stisnjeno kožno gubo pod kotom približno 45 stopinj.
English: Among the 54% of patients (247/456) who were receiving concomitant corticosteroids at the start of PURSUIT-Maintenance, the proportion of patients who maintained clinical response through week 54 and were not receiving concomitant corticosteroids at week 54 was greater in the 50 mg group (38%, 30/78) and 100 mg group (30%, 25/82) compared with the placebo group (21%, 18/87).
Slovenian: Med 54 % bolnikov (247/456), ki so na začetku študije PURSUIT-Maintenance sočasno prejemali kortikosteroide, je bil delež bolnikov, ki se jim je klinični odziv ohranil do 54. tedna in v tem tednu niso sočasno prejemali kortikosteroidov, večji v skupini s 50 mg (38 %, 30/78) in skupini s 100 mg (30 %, 25/82) kot v skupini, ki je prejemala placebo (21 %, 18/87).
English: The dose you delivered can be confirmed by viewing the dose selection notch.
Slovenian: Sproščeni odmerek lahko preverite tako, da pogledate zarezo za izbiro odmerka.
English: • If a caregiver is giving you the injection, they can also use the outer area of the upper arms.
Slovenian: • Če vam injekcijo da negovalec, lahko za injiciranje uporabi tudi zunanji del nadlakta.
English: The solution is clear to slightly opalescent, colourless to light yellow.
Slovenian: Raztopina je bistra do rahlo opalescentna in brezbarvna do svetlo rumena.
English: For all of the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses).
Slovenian: Za vse zgoraj navedene indikacije podatki, ki so na voljo, kažejo, da je klinični odziv običajno dosežen v 12 do 14 tednih zdravljenja (po 3 do 4 odmerkih).
English: Since golimumab exhibited approximately dose proportional PK following a subcutaneous administration, the absolute bioavailability of a golimumab 50 mg or 200 mg dose is expected to be similar.
Slovenian: Ker je imel golimumab po subkutani uporabi približno odmerku sorazmerno farmakokinetiko, je pričakovati podobno absolutno biološko uporabnost tudi po 50 mg ali 200 mg odmerku.
English: Do not inject into skin that is tender, bruised, red, scaly, hard or has scars.
Slovenian: Ne injicirajte v kožo, ki je občutljiva, podpluta, pordela, luskasta, zatrdela ali brazgotinasta.
English: Patients who developed anti-golimumab antibodies generally had low trough steady-state serum concentrations of golimumab (see section 5.1).
Slovenian: Bolniki, pri katerih so se pojavila protitelesa proti golimumabu, so imeli običajno nizke najnižje vrednosti serumskih koncentracij golimumaba v stanju dinamičnega ravnovesja (glejte poglavje 5.1).
English: 175 to < 180
Slovenian: 175 do < 180
English: n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint.
Slovenian: 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: Following induction doses of 200 mg and 100 mg golimumab at week 0 and 2, respectively, and maintenance doses of 50 mg or 100 mg golimumab subcutaneously every 4 weeks thereafter to patients with UC, serum golimumab concentrations reached steady state approximately 14 weeks after the start of therapy.
Slovenian: Po uvedbi indukcijskega odmerka 200 mg golimumaba v tednu 0 oziroma 100 mg golimumaba v 2. tednu ter poznejšo uporabo vzdrževalnih odmerkov 50 mg ali 100 mg golimumaba subkutano na 4 tedne pri bolnikih z UK je koncentracija golimumaba v serumu dosegla stanje dinamičnega ravnovesja približno 14 tednov po začetku zdravljenja.
English: In GO-BEFORE the primary analysis in patients with moderate to severe rheumatoid arthritis (combined Simponi 50 and 100 mg + MTX groups vs MTX alone for ACR50) was not statistically significant at week 24 (p = 0.053).
Slovenian: V študiji GO-BEFORE primarne analize pri bolnikih z zmernim do hudim revmatoidnim artritisom (skupno za skupini, ki sta prejemali zdravilo Simponi 50 mg in 100 mg z MTX, v primerjavi s skupino, ki je prejemala samo MTX za ACR50) v 24. tednu niso bile statistično značilne (p = 0,053).
English: In the controlled portions of clinical trials of all the TNF-blocking agents including golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients.
Slovenian: V nadzorovanem delu kliničnih preskušanj z vsemi zaviralci TNF, vključno z golimumabom, so opazili več primerov limfoma pri bolnikih, ki so se zdravili z zaviralci TNF, kot pri tistih iz kontrolne skupine.