natgillin/translations-raw huggingface dataset:
In all situations described below, the benefit/risk balance of golimumab therapy should be very carefully considered.
V vseh spodaj opisanih primerih je treba zelo skrbno pretehtati razmerje med koristjo in tveganjem zdravljenja z golimumabom.
Week 14 33% 55%*
14. teden 33 % 55 %*
• That treatment with Simponi may increase the risks of serious infection, opportunistic infections, tuberculosis, hepatitis B reactivation and breakthrough infection after administration of live vaccines in infants exposed to golimumab in utero; and when to seek attention from a
• Da lahko zdravljenje z zdravilom Simponi zveča tveganje za resne okužbe, oportunistične okužbe, tuberkulozo, reaktivacijo hepatitisa B in prebijajočo (breakthrough) okužbo po prejemu živega cepiva pri dojenčkih, ki so bili in utero izpostavljeni golimumabu; in kdaj poiskati zdravniško pomoč.
• Contact details of the prescriber.
• Kontaktne podatke zdravnika, ki je predpisal zdravilo.
Continue to hold until the second ‘click' (see figure 8)
Napolnjeni injekcijski peresnik držite še naprej, dokler ne zaslišite drugega ‘klika' (glejte sliko 8)
At week 16, 87% of children were ACR Ped 30 responders, and 79%, 66%, and 36% of children were ACR Ped 50, ACR Ped 70, and ACR Ped 90 responders, respectively.
V 16. tednu je imelo 87 % otrok odziv ACR Ped 30, 79 % otrok odziv ACR Ped 50, 66 % otrok odziv ACR Ped 70 in 36 % otrok odziv ACR Ped 90.
Golimumab has not been studied in patients with CHF.
Golimumaba niso proučevali pri bolnikih s CHF.
• Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
• motnje imunskega sistema, ki lahko prizadenejo pljuča, kožo in bezgavke (najpogosteje se pojavijo v obliki sarkoidoze),
Do not press the plunger while inserting the needle.
Ne pritiskajte bata, medtem ko zabadate iglo.
• Tell your doctor if you think you might be at risk of contracting HBV
• Zdravnika obvestite, če menite, da obstaja tveganje, da se okužite s HBV.
• Increase in blood sugar levels
• zvišanje koncentracije krvnega sladkorja,
If an anaphylactic reaction or other serious allergic reactions occur, administration of golimumab should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba golimumab nemudoma ukiniti in uvesti ustrezno drugo terapijo.
Children with polyarticular course JIA (rheumatoid factor positive or negative polyarthritis, extended oligoarthritis, juvenile psoriatic arthritis or systemic JIA with no current systemic symptoms) were included in the study.
V študijo so bili vključeni otroci s poliartikularnim potekom JIA (poliartritis s pozitivnim ali negativnim revmatoidnim faktorjem, razširjen oligoartritis, juvenilni psoriatični artritis ali sistemski JIA brez trenutnih sistemskih simptomov).
In a single and swift motion, insert the needle through the skin as far as it will go (see figure 6).
Z enim hitrim gibom jo vbodite v kožo, tako globoko, kot gre (glejte sliko 6).
Paediatric population Simponi 100 mg is not recommended in children aged less than 18.
Pediatrična populacija Uporaba zdravila Simponi 100 mg ni priporočljiva za otroke, mlajše od 18 let.
• Slowly take your thumb off the plunger head to allow the empty pre-filled syringe to move up until the entire needle is covered by the needle guard, as shown by the figure 9:
• Počasi snemite palec z glave bata, da se bo prazna napolnjena injekcijska brizga pomaknila navzgor, dokler ne bo vsa igla prekrita s ščitnikom igle, kakor je prikazano na sliki 9:
Before starting treatment with golimumab, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Pred začetkom zdravljenja z golimumabom je treba pri vseh bolnikih oceniti, ali imajo morda aktivno oziroma neaktivno ("latentno") tuberkulozo.
At week 104, X-ray data were available for 114 patients, and 77% showed no progression from baseline.
V 104. tednu pa so bili rentgenski podatki na voljo za 114 bolnikov in 77 % jih ni kazalo nikakršnega napredovanja bolezni v primerjavi z začetnimi vrednostmi.
d MRI sacroiliac joint score n reflects randomised and treated patients
MRI v sakroiliakalnih sklepih n odraža randomizirane in zdravljene bolnike
In a limited number of RA patients treated with subcutaneous golimumab over a 6-month period, concomitant use of MTX reduced the apparent clearance of golimumab by approximately 36%.
Pri omejenem številu bolnikov z RA, ki so bili zdravljeni z golimumabom subkutano več kot 6 mesecev, je sočasna uporaba MTX zmanjšala navidezni očistek golimumaba za približno 36 %.
Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse events, including infection.
Pri prehodu z enega biološkega zdravila na drugega je potrebna previdnost, bolnike pa je treba še naprej spremljati, ker se zaradi prekrivanja biološke učinkovitosti lahko še poveča tveganje za neželene učinke, vključno z okužbami.
The educational programme consists of a Patient Reminder Card to be held by the patient.
Izobraževalni program obsega opozorilno kartico za bolnika, ki jo ima bolnik pri sebi.
If needed, cover injection site with a bandage.
Če je treba, mesto injiciranja pokrijete z obližem.
Placebo-controlled efficacy data were collected and analysed through week 16.
S placebom nadzorovane podatke o učinkovitosti so zbirali in analizirali za obdobje do 16 tednov.
• Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with Simponi treatment.
• Pri bolnikih s hudo trdovratno astmo, kronično obstruktivno pljučno boleznijo (KOPB) in bolnikih, ki veliko kadijo, se lahko pri zdravljenju z zdravilom Simponi poveča tveganje za nastanek raka.
In GO-FORWARD and GO-AFTER, clinically meaningful and statistically significant responses in Disease Activity Scale (DAS)28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001).
V študijah GO-FORWARD in GO-AFTER so opazili klinično pomembne in statistično značilne odzive na lestvici aktivnosti bolezni (Disease Activity Scale - DAS 28) ob vsaki predhodno določeni časovni točki, v 14. tednu in v 24. tednu (p ≤ 0,001).
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Približno v polovici primerov je šlo za limfome, drugi primeri pa so zadevali več različnih malignomov, med drugim tudi redke malignome, običajno povezane z imunosupresijo.
Simponi is for subcutaneous use.
Zdravilo Simponi je namenjeno za subkutano uporabo.
Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
To pomeni, da je potrebna previdnost pri uporabi katerega koli antagonista TNF pri bolnikih s KOPB in pri tistih, ki imajo povečano tveganje za nastanek malignoma, ker veliko kadijo.
1.2 During and after Simponi treatment:
1.2 Med in po zdravljenju z zdravilom Simponi:
• Continue to hold the pre-filled pen down firmly against your skin until you hear a second ‘click'.
• Napolnjeni injekcijski peresnik še naprej držite čvrsto pritisnjen ob kožo, dokler ne boste zaslišali drugega ‘klika'.
• Continue to push the pre-filled pen firmly against your skin and press the raised part of the button with your fingers or thumb.
• Še naprej čvrsto pritiskajte napolnjeni injekcijski peresnik ob kožo in s prsti ali palcem pritisnite na dvignjen del gumba.
Almost all of these patients had also received medicines known as azathioprine or 6-mercaptopurine.
Skoraj vsi ti bolniki so prejemali tudi zdravilo azatioprin ali 6-merkaptopurin.
Patients who did not achieve clinical response at week 6 in the PURSUIT-Induction studies were dosed Simponi 100 mg every 4 weeks in the PURSUIT-Maintenance study.
Bolniki, ki v študijah PURSUIT-Induction v 6. tednu niso dosegli kliničnega odziva, so v študiji PURSUIT-Maintenance prejemali 100 mg zdravila Simponi vsake 4 tedne.
Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:
Nemudoma obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkov zdravila Simponi:
If any changes in the appearance of the skin or growths on the skin occur during or after therapy, tell your doctor.
Če med zdravljenjem ali po njem opazite kakršne koli spremembe videza kože ali izrastke na koži, o tem obvestite zdravnika.
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children.
Poliartikularni juvenilni idiopatski artritis je vnetna bolezen, ki povzroča bolečine v sklepih in otekanje sklepov pri otrocih.
• Severely decreased number of white blood cells
• močno zmanjšano število belih krvnih celic,
• Before starting breast-feeding, your last treatment with Simponi must be at least 6 months ago.
• preden lahko začnete dojiti, mora od zdravljenja z zdravilom Simponi miniti vsaj 6 mesecev.
Your doctor will determine if you should continue Simponi treatment.
Zdravnik bo presodil, ali naj nadaljujete zdravljenje z zdravilom Simponi.
The majority of the injection site reactions were mild and moderate and the most frequent manifestation was injection site erythema.
Večinoma so bile reakcije na mestu injiciranja blage do zmerne, najpogostejši znak te reakcije pa je bil eritem na mestu injiciranja.
Patients with each sub-type of psoriatic arthritis were enrolled, including polyarticular arthritis with no rheumatoid nodules (43%), asymmetric peripheral arthritis (30%), distal interphalangeal (DIP) joint arthritis (15%), spondylitis with peripheral arthritis (11%), and arthritis mutilans (1%).
V študijo so bili vključeni bolniki z vsemi podvrstami psoriatičnega artritisa, vključno s poliartikularnim artritisom brez revmatoidnih vozličev (43 %), asimetričnim perifernim artritisom (30 %), distalnim artritisom interfalangealnih sklepov (DIP) (15 %), spondilitisom s perifernim artritisom (11 %) in artritisom mutilans (1 %).
Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Pokazalo se je, da zdravilo Simponi zmanjša hitrost napredovanja okvare perifernih sklepov, kar so merili z rentgenskim slikanjem pri bolnikih s poliartikularnimi simetričnimi podtipi bolezni (glejte poglavje 5.1), in izboljša telesno funkcijo.
• Hair loss
• izguba las,
The pre-filled pen is a manual injection pen that allows you to set a specific, prescribed dose.
Napolnjeni injekcijski peresnik je peresnik za ročno injiciranje, ki omogoča, da nastavite svoj specifični predpisani odmerek zdravila.
Placebo-controlled efficacy data were collected and analysed through week 24.
S placebom nadzorovani podatki o učinkovitosti zdravila so bili zbrani in analizirani za čas do 24. tedna.
If you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Če se nanje ne boste dovolj dobro odzvali, pa vam bodo lahko predpisali zdravilo Simponi, ki ga boste jemali v kombinaciji z drugim zdravilom, imenovanim metotreksat:
• If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.
• če zamujate več kot 2 tedna, injicirajte pozabljeni odmerek takoj, ko se spomnite, in se posvetujte z zdravnikom ali farmacevtom, kdaj morate vzeti naslednji odmerek.
• Increase in blood cholesterol levels
• zvišanje koncentracije holesterola v krvi,
Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Od 146 bolnikov, ki so bili naključno razvrščeni v skupino za prejemanje zdravila Simponi v odmerku 50 mg, so bili rentgenski podatki za 52. teden na voljo pri 126 bolnikih, od katerih jih 77 % ni kazalo nikakršnega napredovanja bolezni v primerjavi z začetnimi vrednostmi.
This appearance is not unusual for solutions containing protein.
Pri raztopinah, ki vsebujejo beljakovine, tak videz ni neobičajen.
Approximately 93% of patients who were receiving Simponi at the beginning of the open-label extension (week 16) remained on treatment through the end of the study (week 52).
Približno 93 % bolnikov, ki so prejemali zdravilo Simponi na začetku obdobja odprtega zdravljenja v podaljšanju študije (16. teden), je nadaljevalo zdravljenje do konca študije (52. teden).
Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of 0-10 cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
Bolniki, vključeni v to študijo, so imeli aktivno bolezen (opredeljeno z BASDAI ≥ 4 in oceno vseh bolečin v hrbtu na vizualni analogni skali (VAS) ≥ 4, vsako na lestvici od 0 do 10 cm) kljub trenutnemu ali predhodnemu zdravljenju z NSAID ter se predhodno niso zdravili z nobenim biološkim zdravilom, vključno z zdravili proti TNF.
If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away.
Če ste uporabili večji odmerek zdravila Simponi, kot bi smeli Če ste uporabili ali dobili preveč zdravila Simponi (bodisi z enkratnim injiciranjem prevelike količine zdravila ali zaradi prepogoste uporabe zdravila), se takoj posvetujte z zdravnikom ali farmacevtom.
Responses observed in the Simponi treated groups were similar in patients receiving and not receiving concomitant MTX.
Odzivi, ki so jih opazili v skupini bolnikov, zdravljenih z zdravilom Simponi, so bili podobni kot pri bolnikih, ki so sočasno prejemali MTX oziroma ga niso prejemali.
Consistent efficacy was seen in patients regardless of use of DMARDs (MTX, sulfasalazine and/or hydroxychloroquine), HLA-B27 antigen status or baseline CRP levels as assessed by ASAS 20 responses at week 14.
Pri bolnikih so ugotovili stalno učinkovitost ne glede na uporabo terapije DMARD (MTX, sulfasalazin in/ali hidroksiklorokvin), izvid antigena HLA-B27 ali vrednosti CRP na začetku študije, ki so jih določili na podlagi odziva ASAS 20 v 14. tednu.
Please read this Instructions for Use before using the Simponi pre-filled pen and each time you get a new pre-filled pen.
Prosimo, da ta navodila za uporabo preberete pred začetkom uporabe napolnjenega injekcijskega peresnika zdravila Simponi, ter vsakokrat, kot dobite nov napolnjen injekcijski peresnik, saj so lahko na voljo nove informacije.
Effect of weight on pharmacokinetics
Učinek telesne mase na farmakokinetiko
The diagram below (see figure 1) shows what the pre-filled syringe looks like.
Spodnji diagram (glejte sliko 1) prikazuje, kako izgleda napolnjena injekcijska brizga.
Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
O nadaljevanju zdravljenja je treba premisliti pri bolnikih, pri katerih v tem obdobju ni opaznih terapevtskih koristi.
CHAQ: Child Health Assessment Questionaire ESR (mm/h): erythrocyte sedimentation rate (millimetres per hour)
ESR (erythrocyte sedimentation rate) (mm/h): hitrost sedimentacije eritrocitov (milimetri na uro)
Do not share the pre-filled pen with anyone.
Ne delite si napolnjenega injekcijskega peresnika z nikomer.
Due to the higher sensitivity and the improved drug tolerance, a higher incidence of antibodies to golimumab was expected to be detected with the drug-tolerant EIA method compared to the EIA method.
Zaradi višje občutljivosti in izboljšane tolerance za zdravilo je bilo pri metodi EIA, ki je tolerantna za zdravilo, pričakovati detekcijo večjega obsega protiteles proti golimumabu, v primerjavi z metodo EIA.
In a fertility and general reproductive function study in mouse, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, the number of pregnant mice was reduced.
V študiji plodnosti in splošne sposobnosti razmnoževanja pri miših je bilo ob uporabi analognega protitelesa, ki selektivno zavira funkcionalno aktivnost mišjega TNFα, število brejih miši zmanjšano.
Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis Simponi 50 mg given once a month, on the same date each month.
Psoriatični artritis, ankilozirajoči spondilitis ali neradiografski aksialni spondiloartritis Zdravilo Simponi 50 mg dajemo enkrat na mesec, vsak mesec na isti datum.
Among the children who tested positive for antibodies to golimumab, 39% (25/65) had neutralising antibodies.
Med otroki, ki so bili pozitivni na protitelesa proti golimumabu, jih je imelo 39 % (25/65) nevtralizirajoča protitelesa.
Gently, press the plunger until it stops.
Nežno pritisnite bat, dokler se ne ustavi.
Change from baseline n reflects randomised patients * p = 0.015
Začetna vrednost Sprememba glede na začetno vrednost n odraža randomizirane bolnike * p = 0,015
Check the expiration date (‘EXP') printed or written on the back panel of the carton.
Preverite datum izteka roka uporabnosti ("EXP"), ki je natisnjen ali napisan na zadnji strani škatle.
Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy).
Aktivnost UK so ocenili z oceno Mayo na 4 tedne (izginotje odziva so potrdili endoskopsko).
It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion.
Ni znano, ali se golimumab izloča v materino mleko pri človeku in ali se po zaužitju absorbira v sistemski krvni obtok.
Approximately 63% of patients who were receiving Simponi at the beginning of the study extension (week 56), remained on treatment through the end of the study (last golimumab administration at week 212).
Približno 63 % bolnikov, ki je prejemalo zdravilo Simponi na začetku podaljšanja študije (56. teden), je nadaljevalo zdravljenje do konca študije (zadnji odmerek golimumaba v 212. tednu).
While you are waiting you can get the rest of your equipment ready, including an alcohol swab, a cotton ball or gauze and a sharps container.
Med čakanjem si lahko pripravite vse ostale potrebščine, vključno z alkoholnim zložencem, kosmom vate ali zložencem iz gaze ter posodo za odlaganje ostrih odpadkov.
The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age.
Varnost golimumaba so preučevali v študiji faze III pri 173 bolnikih s pJIA, starih od 2 do 17 let.
Malignancies other than lymphoma
Drugi malignomi razen limfoma
• Pain and ulcers in the mouth
• bolečine in razjede v ustih,
However, you and your doctor may decide that you may inject Simponi to yourself or to your child.
Vendar se lahko skupaj z zdravnikom odločite, da boste zdravilo Simponi sebi ali svojemu otroku injicirali sami.
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
• lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah),
Insert needle and hold in place
Zabodite iglo in držite pri miru
Do not inject if the perforations on the carton are broken.
Ne injicirajte, če je perforacija na škatli poškodovana/pretrgana.
A generally greater effect of Simponi 50 mg + MTX versus MTX alone was demonstrated in the indicated population compared with the overall population.
Na splošno se je pokazal večji učinek zdravila Simponi 50 mg z MTX v primerjavi s samim MTX pri navedeni populaciji v primerjavi s celotno populacijo.
• Do not warm the pre-filled pen in any other way (for example, do not warm it in a microwave or in hot water).
• Napolnjenega injekcijskega peresnika ne smete segrevati na noben drug način (na primer v mikrovalovni pečici ali v vroči vodi).
defined as a decrease from baseline in the Mayo score by ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or a rectal bleeding subscore of 0 or 1.
Opredeljeno kot zmanjšanje ocene Mayo za ≥ 30 % in ≥ 3 točke v primerjavi z izhodiščem ob hkratnem zmanjšanju ocene rektalne krvavitve za ≥ 1 ali ob hkratni oceni rektalne krvavitve 0 ali
The majority of lymphomas occurred in study GO-AFTER, which enrolled patients previously exposed to anti-TNF agents who had longer disease duration and more refractory disease (see section 4.4).
Večina limfomov se je pojavila v študiji GO-AFTER, v katero so bili vključeni bolniki, ki so bili že prej izpostavljeni zdravilom proti TNF in pri katerih je bilo trajanje bolezni daljše in je bila le-ta bolj odporna na zdravljenje (glejte poglavje 4.4).
Simponi contains sorbitol (E420).
Zdravilo Simponi vsebuje sorbitol (E420).
• Inflammation of blood vessels in internal organs
• vnetje krvnih žil v notranjih organih,
Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).
0,05 ml zdravila vsebuje 2,05 mg sorbitola (E420).
Dose Lines
Črte z odmerki
• serious infections (including TB, bacterial infections including serious blood infections and pneumonia, severe fungal infections and other opportunistic infections) (common).
• resne okužbe (vključno s TB, bakterijskimi okužbami, vključno z resnimi okužbami krvi in pljučnico, hudimi glivnimi okužbami in drugimi oportunističnimi okužbami) (pogosto).
• the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
• zdravljenje zmernega do hudega, aktivnega revmatoidnega artritisa pri odraslih, če je bil odziv na zdravljenje z antirevmatiki, ki vplivajo na potek bolezni (disease-modifying anti-rheumatic drug - DMARD), vključno z MTX, nezadosten;
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor).
Vsem bolnikom je treba svetovati, naj nemudoma poiščejo zdravniško pomoč, če se pri njih pojavijo znaki in simptomi, ki kažejo na pojav krvne diskrazije (npr. dolgotrajno zvišana telesna temperatura, podplutbe, krvavitve in bledica).
Table 1: Simponi dose in millilitres (mL) by height and weight of patients with pJIA Total Body Weight (kg)
Preglednica 1: Odmerek zdravila Simponi v mililitrih (ml) glede na telesno višino in telesno maso bolnikov s pJIA Celotna telesna masa (kg)
• blood disease (common).
• bolezni krvi (pogosto).
Week 24 5% 20%*
24. teden 5 % 20 %*
If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.
Če menite, da je prišlo do napake pri injiciranju, ali ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself.
Če si želite sami injicirati zdravilo Simponi, vas mora zdravstveni delavec poučiti, kako si pravilno pripravite in date injekcijo.
• You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
• V napolnjeni injekcijski brizgi boste morda opazili zračni mehurček ali kapljico tekočine na koncu igle.
Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).
Čeprav sočasna uporaba MTX vodi do večjih najnižjih koncentracij golimumaba v stanju dinamičnega ravnovesja pri bolnikih z RA, PsA ali AS, podatki, ki so na voljo, ne kažejo potrebe po prilagoditvi odmerka, bodisi pri golimumabu ali pri MTX (glejte poglavje 5.2).
The efficacy of Simponi was evaluated in two randomised, double-blind, placebo-controlled clinical studies in adult patients.
Učinkovitost zdravila Simponi so ocenili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah pri odraslih bolnikih.