natgillin/translations-raw huggingface dataset:
Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Bolniki so med preskušanjem lahko sočasno prejemali stabilne odmerke metotreksata, nizke odmerke kortikosteroidov (v odmerkih, enakovrednih ≤ 10 mg prednizona) in/ali nesteroidna protivnetna zdravila (NSAID).
Listed in Table 2 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
V preglednici 2 so neželeni učinki, opaženi v kliničnih preskušanjih in med spremljanjem zdravila po prihodu na trg, navedeni glede na organski sistem in pogostnosti, pri čemer so uporabljene naslednje kategorije: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
C. Check the liquid in the syringe Hold the syringe by its body, with the covered needle pointing down.
C. Preverite tekočino v napolnjeni injekcijski brizgi Injekcijsko brizgo primite za telo tako, da je pokrita igla usmerjena navzdol.
One mL pre-filled syringe (Type 1 glass) in a pre-filled pen.
1 ml napolnjena injekcijska brizga (steklo tipa 1) v napolnjenem injekcijskem peresniku.
The safety and efficacy of ORENCIA solution for injection in pre-filled pen for subcutaneous administration in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila ORENCIA raztopina za injiciranje v napolnjenem injekcijskem peresniku za subkutano uporabo pri otrocih, mlajših od 18 let, nista bili dokazani.
Antibodies directed against the whole abatacept molecule or to the CTLA-4 portion of abatacept were assessed by an ECL assay in patients with pJIA following repeated treatment with subcutaneous abatacept.
Protitelesa proti celotni molekuli abatacepta ali CTLA-4 delu abatacepta so ovrednotili z ECL testi pri bolnikih s pJIA po ponavljajočem se subkutanem zdravljenju z abataceptom.
Patients in the sub-study (n=117) of the open-label extension of study SC-I received 125 mg of subcutaneous abatacept administered weekly via the pre-filled syringe for at least 4 months, and were then switched to receive 125 mg SC abatacept administered weekly via the pre-filled pen for 12 weeks.
Bolniki v podštudiji (n=117) odprtega podaljška študije SC-I so najmanj 4 mesece enkrat na teden prejemali 125 mg abatacepta subkutano v napolnjeni injekcijski brizgi, nato pa so za 12 tednov prešli na uporabo 125 mg abatacepta s.c. enkrat na teden v napolnjenem injekcijskem peresniku.
In the placebo-controlled clinical trials with abatacept, infections at least possibly related to treatment were reported in 22.7% of abatacept-treated patients and 20.5% of placebo-treated patients.
V s placebom nadzorovanih kliničnih preskušanjih, izvedenih z abataceptom, so o okužbah, ki bi lahko bile povezane z zdravljenjem, poročali pri 22,7% bolnikov, ki so prejemali abatacept, in 20,5% bolnikov, ki so prejemali placebo.
Study II, III, IV, and VI patients were randomised to receive a fixed dose approximating 10 mg/kg of abatacept or placebo for 12 (studies II, IV, and VI) or 6 months (study III).
V študijah II, III, IV in VI so bili bolniki randomizirani tako, da so 12 mesecev (študije II, IV in VI) ali 6 mesecev (študija III) prejemali fiksni odmerek približno 10 mg/kg abatacepta ali placeba.
The safety and efficacy of abatacept in the ongoing SC study were consistent with the results seen with abatacept in the IV study (see section 5.1 of the ORENCIA solution for injection in pre-filled syringe SmPC for complete study description and results).
Varnost in učinkovitost abatacepta v študiji subkutane uporabe, ki še poteka, je konsistentna z rezultati študije intravenske uporabe abatacepta (za popoln opis študije in rezultate glejte poglavje 5.1 povzetka glavnih značilnosti zdravila ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi).
Record the date, time and site where you injected.
Zabeležite datum, čas in mesto injiciranja.
Examine the ClickJect Pre-filled Pen:
Preverite ClickJect napolnjen injekcijski peresnik:
The dose of abatacept was 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1,000 mg for patients weighing greater than 100 kg.
Pri bolnikih s telesno maso, manjšo od 60 kg, je bil odmerek abatacepta 500 mg, pri bolnikih s telesno maso od 60 do 100 kg 750 mg, pri bolnikih s telesno maso, večjo od 100 kg, pa 1.000 mg.
The COPD patients treated with abatacept developed adverse reactions more frequently than those treated with placebo (51.4% vs. 47.1%, respectively).
Pri bolnikih s KOPB, ki so prejemali abatacept, so bili neželeni učinki pogostejši kot pri bolnikih, ki so prejemali placebo (51,4% v primerjavi s 47,1%).
Structural and inflammatory MRI assessment in study SC-III Mean Treatment Difference between Abatacept SC+MTX vs. MTX at 12 Months (95% CI)* MRI Erosion Score
MRI ocena strukturnih in vnetnih sprememb v študiji SC-III Povprečna razlika zdravljenja med abatacept s.c.+MTX v primerjavi z MTX v 12. mesecu (95 % IZ)*
Before you use ORENCIA, your doctor may examine you for hepatitis.
Preden boste začeli uporabljati zdravilo ORENCIA vas bo zdravnik morda pregledal na hepatitis.
What you need to know before you use ORENCIA 3.
Kaj morate vedeti, preden boste uporabili zdravilo ORENCIA 3.
B. Prepare your injection site Wipe your injection site with an alcohol swab in a circular motion.
B. Priprava mesta za injiciranje S krožnim gibom obrišite mesto injiciranja z alkoholnim zložencem.
Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in seven pooled intravenous studies (for studies II, III, IV and V see section 5.1) were more common in the abatacept-treated patients than the placebo-treated patients (5.2% for abatacept, 3.7% for placebo).
V sedmih združenih študijah intravenske uporabe (študije II, III, IV in V, glejte poglavje 5.1) so bili akutni učinki, povezani z infundiranjem (neželeni učinki, ki so se pojavili v 1 uri po začetku infundiranja), pogostejši pri bolnikih, ki so prejemali abatacept, kot pri bolnikih, ki so prejemali placebo (5,2% za abatacept, 3,7% za placebo).
What ORENCIA looks like and contents of the pack ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution.
Izgled zdravila ORENCIA in vsebina pakiranja ORENCIA raztopina za injiciranja (injekcija) je bistra, brezbarvna do bledo rumena raztopina.
Therefore, concurrent therapy with abatacept and a TNF-inhibitor is not recommended.
Sočasnega zdravljenja z abataceptom in zaviralcem TNF ne priporočamo.
Of the 219 patients with pJIA treated with subcutaneous abatacept during the first 4-month abatacept treatment, the frequency of local injection reactions was 4.6% (10/219); injection site pain and injection site erythema were the most frequently reported local injection reactions.
Od 219 bolnikov s pJIA, ki so se zdravili z abataceptom subkutano v prvih 4 mesecih zdravljenja z abataceptom, je pogostnost lokalnih reakcij na mestu injiciranja znašala 4,6% (10/219).
Rare (may affect up to 1 in 1,000 people): tuberculosis inflammation of uterus, fallopian tubes and/or ovaries gastrointestinal infection cancer of white blood cells, lung cancer
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): tuberkuloza, vnetje maternice, jajcevodov in/ali jajčnikov, okužba prebavil, rak belih krvnih celic, pljučni rak.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg of abatacept.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 250 mg abatacepta.
Clinical responses in controlled trials Percent of patients Intravenous administration
Preglednica 3: Klinični odzivi v nadzorovanih preskušanjih Odstotek bolnikov Intravenska uporaba
Co-administration of ORENCIA with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system (see section 4.5).
Pri sočasni uporabi zdravila ORENCIA in bioloških imunosupresivnih ali imunomodulirajočih zdravil se učinki abatacepta na imunski sistem lahko okrepijo (glejte poglavje 4.5).
Check that the expiry date and batch number match the ones on the carton.
Preverite, če se datum izteka roka uporabnosti zdravila in številka serije na injekcijski brizgi ujema s tistim na škatli.
Consistent with previous experience, titers and persistence of antibody responses were generally low and did not increase upon continued dosing (6.8% subjects were seropositive on 2 consecutive visits), and there was no apparent correlation of antibody development to clinical response, adverse events, or pharmacokinetics.
Titri in vztrajanje protitelesnega odziva so bili v skladu s predhodnimi izkušnjami na splošno nizki, pri nadaljevanju zdravljenja pa se niso povečevali (6,8 % oseb je bilo seropozitivnih pri dveh zaporednih obiskih).
Doctor's Phone: ____________________
Telefonska številka zdravnika:
Structural joint damage was assessed radiographically over a two-year period in studies II, VI, and SC-II.
Strukturne poškodbe sklepa so vrednotili radiološko med dveletnim obdobjem v študijah II, VI in SCII.
In the 6 to 17 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 4.7% (8/172): 2.3% (4/172) on treatment and 13.6% (6/44) after discontinuation of abatacept (≥ 28 days after the last dose).
V kohorti bolnikov, starih od 6 do 17 let, je celokupen delež seropozitivnosti v kumulativnem obdobju, vključno z obdobjem spremljanja po uporabi abatacepta, znašal 4,7 % (8/172): 2,3 % (4/172) med zdravljenjem in 13,6 % (6/44) po ukinitvi zdravljenja z abataceptom (≥ 28 dni po uporabi zadnjega odmerka).
Abatacept has been studied in patients with active psoriatic arthritis in two placebo-controlled clinical trials (341 patients with abatacept, 253 patients with placebo) (see section 5.1).
Uporabo abatacepta so raziskovali pri bolnikih z aktivnim psoriaznim artritisom v dveh s placebom nadzorovanih kliničnih preskušanjih (341 bolnikov je prejemalo abatacept, 253 bolnikov pa placebo) (glejte poglavje 5.1).
If you are given more ORENCIA than you should If this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Če ste prejeli večji odmerek zdravila ORENCIA, kot bi smeli V tem primeru bo zdravnik nadziral morebiten pojav katerega koli znaka ali simptoma neželenih učinkov in po potrebi uvedel zdravljenje teh simptomov.
No studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of abatacept.
Študije, ki bi ovrednotile vpliv okvare ledvic ali jeter na farmakokinetiko abatacepta, niso bile izvedene.
Table 10:
Preglednica 10:
Physical Function Response
Odziv v obliki fizične funkcije
ACR 20 Day 15 Month 3 Month 6 Month 12
ACR 20 15. dan 3. mesec 6. mesec 12. mesec
What ORENCIA looks like and contents of the pack ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution provided in a pre-filled pen called ClickJect.
Izgled zdravila ORENCIA in vsebina pakiranja ORENCIA raztopina za injiciranja (injekcija) je bistra, brezbarvna do bledo rumena raztopina v napolnjenem injekcijskem peresniku, imenovanem ClickJect.
Immunogenicity in patients with pJIA treated with subcutaneous abatacept
Imunogenost pri bolnikih s pJIA, ki so se zdravili z abataceptom subkutano
Remove the needle cover by holding the body of the pre-filled syringe with one hand and pulling the cover straight off with your other hand.
Odstranite pokrovček igle tako, da z eno roko primete za telo napolnjene injekcijske brizge z drugo roko pa za pokrovček igle in ga naravnost potegnite z igle.
Insert the needle Gently insert the needle into the pinched skin at a 45º angle.
Zabodite iglo Iglo nežno zabodite v kožno gubo pod kotom 45º.
ORENCIA can be used by adults over 65 with no change in dose.
Pri odraslih, starejših od 65 let, odmerka zdravila ORENCIA ni treba prilagajati.
Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infections or underlying conditions which may predispose them to infections.
Pri odločanju za uporabo zdravila ORENCIA pri bolnikih z anamnezo ponavljajočih se okužb ali drugih bolezni, ki so lahko predispozicija za okužbe, morajo biti zdravniki previdni.
The abatacept + MTX group had less progression in structural damage compared with MTX group as reflected by mean treatment difference of the abatacept + MTX group versus MTX group (Table 6).
V skupini, ki je prejemala abatacept + MTX, so strukturne poškodbe manj napredovale kot v skupini z MTX, na kar kaže povprečna razlika zdravljenja med skupino, ki je prejemala abatacept + MTX v primerjavi s skupino z MTX (preglednica 6).
ACR Pedi 30 responders at the end of Period A were randomised into Period B, the double-blind, withdrawal phase, to receive either abatacept or placebo for 6 months or until JIA flare.
Bolniki z odzivom ACR Pedi 30 na koncu obdobja A so bili randomizirani v obdobje B, dvojno slepo, odtegnitveno fazo, in so 6 mesecev ali do poslabšanja JIA prejemali abatacept ali placebo.
ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults.
Zdravilo ORENCIA uporabljamo za zdravljenje revmatoidnega artritisa in psoriaznega artritisa pri odraslih.
Upper respiratory tract infection (including tracheitis, nasopharyngitis, and sinusitis)
Infekcijske in parazitske bolezni zelo pogosti okužba zgornjih dihal (vključno s traheitisom, nazofaringitisom in sinuzitisom)
Don't throw away used syringes in your household rubbish or recycling bins.
Uporabljene injekcijske brizge ne smete odvreči med gospodinjske odpadke ali v posodo za recikliranje.
In post-marketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported.
Med spremljanjem zdravila po prihodu na trg so poročali o smrtnem primeru zaradi anafilaksije po prvem infundiranju zdravila ORENCIA.
Before you are given ORENCIA, your doctor may examine you for hepatitis.
Preden boste prejeli zdravilo ORENCIA vas bo zdravnik morda pregledal na hepatitis.
After reconstitution, each mL contains 25 mg of abatacept.
Po rekonstituciji en ml vsebuje 25 mg abatacepta.
It is important that you tell your baby's doctors and other health care professionals about your ORENCIA use during your pregnancy so they can decide when your baby should receive any vaccine.
Pomembno je, da otrokovega zdravnika in drugo zdravstveno osebje, ki skrbi za otroka, obvestite o uporabi zdravila ORENCIA med nosečnostjo, da bodo le-ti lahko presodili, kdaj lahko otrok prejme katero koli cepivo.
Check with your doctor before you are given any vaccines.
Pred vsakim cepljenjem se posvetujte s svojim zdravnikom.
Avoid any areas with scars or stretch marks.
Izogibajte se predelov z brazgotinami ali s strijami.
The presence of antibodies was not associated with adverse reactions, or with changes in efficacy or serum abatacept concentrations, in either cohort.
Prisotnost protiteles v nobeni kohorti bolnikov ni bila povezana z neželenimi učinki ali s spremembami učinkovitosti ali spremembami koncentracij abatacepta v serumu.
More than 100 kg
Več kot 100 kg
To minimise foam formation in solutions of ORENCIA the vial should be rotated with gentle swirling until the contents are completely dissolved.
Da bi bilo penjenje raztopine zdravila ORENCIA čim manjše, vialo nežno obračajte, dokler se vsebina popolnoma ne raztopi.
ORENCIA is usually used in combination with methotrexate, although ORENCIA may also be used alone if treatment with methotrexate is inappropriate.
Zdravilo ORENCIA se običajno uporablja v kombinaciji z metotreksatom, vendar pa se zdravilo ORENCIA lahko uporablja tudi samo, če zdravljenje z metotreksatom za bolnika ni primerno.
The recommended weekly dose of ORENCIA solution for injection in pre-filled syringe for patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis should be initiated without an intravenous loading dose and administered utilizing the weight range-based dosing as specified in the table below:
Priporočeni tedenski odmerek zdravila ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi pri bolnikih, starih od 2 do 17 let, s poliartikularnim juvenilnim idiopatskim artritisom je treba uvesti brez intravenskega polnilnega odmerka, odmerjanje pa temelji na telesni masi, kot je prikazano v preglednici v nadaljevanju:
There may be a small air bubble in the liquid in the syringe.
Med tekočino v injekcijski brizgi je lahko prisoten majhen zračni mehurček.
In SC-III, increased rates of immunogenicity were observed in subjects tested during 6 months of complete drug withdrawal in the abatacept+MTX and abatacept monotherapy groups (37.7% [29/77] and 44.1% [27/59], respectively) with generally low titer antibody responses.
V študiji SC-III so pri osebah, testiranih v času 6-mesečne popolne odtegnitve zdravila, opazili večji delež imunogenosti pri osebah iz skupine, ki je prejemala abatacept+MTX, in skupine, ki je prejemala abatacept v monoterapiji (37,7 % [29/77] in 44,1 % [27/59]), titri protiteles pa so bili na splošno nizki.
The Type 1 glass syringe has a coated stopper and fixed stainless steel needle covered with a rigid needle shield.
Brizga iz stekla tipa 1 ima obložen zamašek in fiksno iglo iz nerjavečega jekla, ki je pokrita z neupogljivim varovalom.
For patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis, the recommended weekly dose of ORENCIA solution for injection in pre-filled syringe is based on body weight:
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 2 do 17 let, je priporočeni tedenski odmerek zdravila ORENCIA raztopina za injiciranje v napolnjeni injekcijski brizgi odvisen od telesne mase:
AFTER THE INJECTION
PO INJICIRANJU
Needle cover Expiration date
Pokrovček igle Datum izteka roka
The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg abatacept given every week regardless of weight.
Priporočeni odmerek zdravila ORENCIA za odrasle z revmatoidnim artritisom ali s psoriaznim artritisom je 125 mg abatacepta enkrat na teden, ne glede na telesno maso.
The pJIA IV study included 190 patients in the 6 to 17 year age cohort.
V študijo intravenske uporabe pri pJIA je bilo vključenih 190 bolnikov, starih od 6 do 17 let.
If needed, you may cover the injection site with a small adhesive plaster.
Po potrebi lahko mesto injiciranja zaščitite z manjšim samolepilnim obližem.
It is recommended that patients with polyarticular juvenile idiopathic arthritis, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to starting ORENCIA therapy.
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom je pred uvedbo zdravljenja z zdravilom ORENCIA priporočljivo po možnosti opraviti vsa priporočena cepljenja v skladu s trenutno veljavnimi smernicami za cepljenje.
Activation Button (BLUE)
Gumb za injiciranje (MODER)
Patients had active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.
Bolniki so kljub predhodnemu zdravljenju z DMARD imeli aktivni PsA (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) ter eno ustrezno psoriazno kožno spremembo s premerom vsaj 2 cm.
Study I patients were randomised to receive abatacept 2 or 10 mg/kg or placebo for 12 months.
V študiji I so bili bolniki za 12 mesecev randomizirani na abatacept v odmerku 2 ali 10 mg/kg ali placebo.
A greater percentage of abatacept- than placebotreated patients with COPD developed a serious adverse reaction (5.4% vs. 0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Resni neželeni učinki so bili pri bolnikih s KOPB, ki so prejemali abatacept, pogostejši kot pri bolnikih, ki so prejemali placebo (5,4% v primerjavi z 0%), vključevali so poslabšanje KOPB (1 od 37 bolnikov [2,7%]) in bronhitis (1 od 37 bolnikov [2,7%]).
Clinical responses were maintained or continued to improve up to one year in studies PsA-I and PsA-II.
V študijah PsA-I in PsA-II so se klinični odzivi ohranili ali izboljševali do enega leta.
Do not store any unused portion of the infusion solution for reuse.
Neporabljene vsebine raztopine za infundiranje ne shranjujte za ponovno uporabo.
Slow down the damage to your bones and joints.
upočasnitev napredovanja poškodb kosti in sklepov,
In PsA-I, patients were randomised to receive intravenous placebo or abatacept 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), or two doses of 30 mg/kg followed by 10 mg/kg (30/10 mg/kg), on day 1, 15, 29, and then every 28 days thereafter.
V študiji PsA-I so bili bolniki randomizirani na intravensko prejemanje placeba ali abatacepta v odmerku 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg) ali dva odmerka po 30 mg/kg, ki mu je sledil odmerek 10 mg/kg (30/10 mg/kg) na 1., 15. in 29. dan, nato pa na vsakih 28 dni.
ORENCIA powder for concentrate for solution for infusion has not been studied in children and adolescents under 6 years of age, therefore ORENCIA powder for concentrate for infusion is not recommended for use in this patient population.
Zdravilo ORENCIA prašek za koncentrat za raztopino za infundiranje pri otrocih in mladostnikih, mlajših od 6 let, ni bilo raziskano, zato uporabe zdravila ORENCIA prašek za koncentrat za raztopino za infundiranje pri tej skupini bolnikov ne priporočamo.
The most common side effects with ORENCIA are infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below.
Kot je navedeno v nadaljevanju, so najpogostejši neželeni učinki zdravila ORENCIA okužbe zgornjih dihal (vključno z okužbami nosu in žrela), glavobol in slabost.
However, in some, RA may progress rapidly and yet other people may have RA for a limited period of time and then enter a period of remission.
Pri nekaterih bolnikih lahko RA napreduje hitro, pri nekaterih bolnikih pa se RA lahko po določenem času začasno izboljša.
Let your Pre-filled syringe warm up.
Počakajte, da se napolnjena injekcijska brizga segreje.
Improvement from baseline as measured by HAQ-DI at 24 months and over time was also similar between abatacept SC and adalimumab SC.
Izboljšanje od izhodišča, ovrednoteno z vprašalnikom HAQ-DI (Health Assessment Questionnaire Disability Index), je bilo po 24 mesecih in tekom časa pri abataceptu s.c. in adalimumabu s.c prav tako podobno.
What ORENCIA contains
Kaj vsebuje navodilo
Step 1: Preparing for an ORENCIA Injection Gather supplies for your injection on a clean, flat surface.
1. korak: Priprava na injiciranje zdravila ORENCIA Pripravite material za injiciranje na čisto in ravno površino Ovojnina vsebuje le napolnjeno injekcijsko brizgo:
In carcinogenicity studies in mice, an increase in lymphomas and mammary tumours were noted.
V študijah kancerogenega potenciala so pri miših opazili večjo pojavnost limfomov in tumorjev mlečne žleze.
In study SC-I, the goal was to demonstrate non-inferiority of the efficacy and comparability of the safety of abatacept subcutaneous relative to intravenous administration in subjects with moderate to severely active RA and experiencing inadequate response to MTX.
Cilj študije SC-I je bil dokazati neinferiorno učinkovitost in primerljivo varnost subkutane uporabe abatacepta v primerjavi z intravensko uporabo pri bolnikih z zmernim do hudo aktivnim revmatoidnim artritisom in nezadostnim odzivom na MTX.
Uncommon Conjunctivitis, dry eye, visual acuity reduced
Očesne bolezni občasni konjunktivitis, suhe oči, zmanjšana ostrina vida
Upon withdrawal of abatacept subcutaneous treatment, the increased rate of immunogenicity was consistent with that seen upon discontinuation of abatacept administered intravenously.
Povečan delež imunogenosti po prekinitvi subkutane uporabe abatacepta je bil v skladu s tistim po prekinitvi intravenske uporabe abatacepta.
STEP 3: Inject ORENCIA
KORAK: Injiciranje zdravila ORENCIA