FrancophonIA/ELRC3.0 huggingface dataset:
English: After influenza vaccination, 73 of 119 abatacept-treated patients without protective antibody levels at baseline were able to mount an adequate immune response of at least a 4-fold increase in antibody titers to trivalent influenza vaccine.
Slovenian: Po cepljenju proti gripi je bil zadosten imunski odziv, to je vsaj 4-kratno povečanje titrov protiteles proti trivalentnemu cepivu proti gripi, dosežen pri 73 od 119 bolnikov, ki so se zdravili z abataceptom in so bili v izhodišču brez titra zaščitnih protiteles.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala
English: Higher ACR 20 responses in study PsA-II were seen with abatacept 125 mg subcutaneous vs. placebo irrespective of concomitant non-biological DMARD treatment.
Slovenian: V študiji PsA-II so večje odzive ACR 20 opazili pri uporabi abatacepta v odmerku 125 mg subkutano v primerjavi s placebom ne glede na sočasno nebiološko zdravljenje z DMARD.
English: DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.
Slovenian: NE odstranjujte pokrovčka igle z injekcijskega peresnika medtem, ko se segreva na sobno temperaturo.
English: Do not use ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila ORENCIA če ste alergični na abatacept ali katero koli sestavino tega zdravila (navedeno v poglavju 6); če imate hudo ali nenadzorovano okužbo, zdravila ORENCIA ne smete začeti uporabljati.
English: Embryo-foetal development studies were conducted with abatacept in mice, rats, and rabbits at doses up to 20 to 30 times a human 10 mg/kg dose and no undesirable effects were observed in the offspring.
Slovenian: Študije vplivov na razvoj zarodka/plodu so bile izvedene na miših, podganah in kuncih, z odmerki, ki so bili 20- do 30krat večji od odmerka 10 mg/kg pri človeku.
English: Immunogenicity in adults treated with intravenous abatacept
Slovenian: Imunogenost pri odraslih, ki so se z abataceptom zdravili intravensko
English: Methotrexate, NSAIDs, corticosteroids, and TNF-inhibitors were not found to influence abatacept clearance.
Slovenian: Metotreksat, nesteroidna protivnetna zdravila, kortikosteroidi in zaviralci TNF niso vplivali na očistek abatacepta.
English: 1 mL Fill line
Slovenian: 1 ml oznaka polnjenja
English: Greater improvements were seen with abatacept than with placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Slovenian: Pri drugih merilih aktivnosti revmatoidnega artritisa, ki niso vključena v kriterije odziva ACR, npr. jutranja okorelost, so pri uporabi abatacepta opazili večje izboljšanje kot pri placebu.
English: There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebocontrolled period.
Slovenian: Med 24-tedenskim, s placebom nadzorovanim obdobjem, v nobeni skupini zdravljenja ni bilo neželenih učinkov, ki bi se pojavili pri ≥ 2%.
English: Month 6 Month 12 76%‡
Slovenian: 3. mesec 64%†† 6. mesec 75%† 12. mesec 76%‡
English: Cotton ball or gauze
Slovenian: Kosem vate ali gaza
English: It is normal to see an air bubble, and there is no reason to remove it. All contents of the syringe should be injected.
Slovenian: Prisotnost zračnega mehurčka je običajna in ga ni treba odstranjevati.
English: Proceed to Step 1
Slovenian: Nadaljujte s 1. korakom.
English: Uncommon Increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis
Slovenian: občasni večja nagnjenost k modricam, suha koža, alopecija, srbenje, koprivnica, psoriaza, akne, rdečina, čezmerno znojenje
English: Do not touch the injection site again before giving the injection.
Slovenian: Ne dotikajte se več mesta injiciranja pred injiciranjem zdravila.
English: The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the subcutaneous placebo group (intravenous abatacept), respectively.
Slovenian: V skupini, ki je abatacept prejemala subkutano, je celokupna pojavnost reakcij na mestu injiciranja znašala 2,6% (19/736), v skupini, ki je subkutano prejemala placebo (abatacept intravensko) pa 2,5% (18/721).
English: Of the 133 (70%) patients with no prior TNF-inhibitor therapy, 101 (76%) achieved at least an ACR Pedi 30 response; of the 57 patients who had received prior TNF-inhibitor therapy, 22 (39%) achieved at least an ACR Pedi 30 response.
Slovenian: ACR Pedi 30 dosežen pri 101 bolniku (76 %).Od 57 bolnikov, ki so se predhodno zdravili z zaviralci TNF, je bil odziv vsaj ACR Pedi 30 dosežen pri 22 bolnikih (39 %).
English: * p < 0.05, abatacept vs. placebo.
Slovenian: * p < 0,05, abatacept v primerjavi s placebom.
English: The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Slovenian: Injekcijska brizga iz stekla tipa 1 ima z bromobutilom obložen zamašek in fiksno iglo iz nerjavečega jekla, ki je pokrita z neupogljivim varovalom.
English: SDAI Clinical Remissionb Estimate of Difference (95% CI) vs. MTX
Slovenian: SDAI klinična remisijab Ocenjena razlika (95 % IZ) v primerjavi z MTX
English: They had active disease, with a mean active joint count of 11.8, mean number of joints with loss of motion of 10.3, and a mean elevated C-reactive protein (CRP) level of 1.24 mg/dL at baseline.
Slovenian: V izhodišču so imeli aktivno bolezen s srednjo vrednostjo števila aktivno prizadetih sklepov 11,8, srednjo vrednostjo števila sklepov z omejeno gibljivostjo 10,3 in zvišano vrednost Creaktivnega proteina (CRP) (srednja vrednost 1,24 mg/dl).
English: The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:
Slovenian: Vsi v nadaljevanju navedeni neželeni učinki so bili opaženi pri uporabi zdravila ORENCIA v kliničnih preskušanjih pri odraslih:
English: The proportion of patients who discontinued treatment due to ARs was 3.0% for abatacept-treated patients and 2.0% for placebo-treated patients.
Slovenian: Zaradi neželenih učinkov zdravila je bilo zdravljenje prekinjeno pri 3,0% bolnikov, ki so prejemali abatacept in 2,0% bolnikov, ki so prejemali placebo.
English: If a patient misses an injection of ORENCIA and is within three days of the planned date, he/she should be instructed to take the missed dose immediately and remain on the original weekly schedule.
Slovenian: Če si je bolnik pozabil injicirati zdravilo ORENCIA in od predvidenega dneva ni minilo več kot tri dni, si mora pozabljeni odmerek injicirati takoj, nato pa naj nadaljuje z uporabo zdravila po prvotni tedenski shemi.
English: Patients should be screened for latent tuberculosis prior to initiating ORENCIA.
Slovenian: Pred uvedbo zdravljenja z zdravilom ORENCIA je pri bolnikih treba opraviti presejalni test za latentno tuberkulozo.
English: Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 50 mg abatacepta v 0,4 ml.
English: Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in studies II, III, IV, V, and VI and the modified HAQ-DI in study I. The results from studies II, III, and VI are shown in Table 7.
Slovenian: Izboljšanje fizične funkcije je bilo v študijah II, III, IV, V in VI ovrednoteno z indeksom nezmožnosti na osnovi vprašalnika za oceno zdravstvenega stanja (HAQ-DI - Health Assessment Questionnaire Disability Index), v študiji I pa z modificiranim indeksom HAQ-DI.
English: Release skin pinch.
Slovenian: Sprostite kožno gubo.
English: In study II, among patients with clinically meaningful improvement at month 12, 88% retained the response at month 18, and 85% retained the response at month 24.
Slovenian: V študiji II se je po 18 mesecih odziv ohranil pri 88% bolnikov s klinično pomembnim izboljšanjem po 12 mesecih in po 24 mesecih pri 85% bolnikov s klinično pomembnim izboljšanjem po 12 mesecih.
English: * p < 0.05 vs placebo, p values not assessed for ACR 50 and ACR 70. a 37% of patients were previously treated with TNF inhibitor.
Slovenian: * p < 0,05 v primerjavi s placebom, p vrednosti za odziva ACR 50 in ACR 70 niso bile ovrednotene.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'.
Slovenian: Zdravilo ORENCIA vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
English: Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride 4.
Slovenian: Pomožne snovi: maltoza, natrijev dihidrogenfosfat monohidrat in natrijev klorid.
English: Remove one pre-filled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.
Slovenian: Iz hladilnika vzemite eno napolnjeno injekcijsko brizgo in počakajte 30 minut, da se segreje na sobno temperature.
English: Allergic reactions have been reported uncommonly with abatacept administration in clinical trials, where patients were not required to be pretreated to prevent allergic reactions (see section 4.8).
Slovenian: V kliničnih preskušanjih, kjer predhodno zdravljenje za preprečitev alergijskih reakcij ni bilo potrebno, so po aplikaciji abatacepta občasno poročali o pojavu alergijskih reakcij (glejte poglavje 4.8).
English: If a patient misses an injection of abatacept and is within three days of the planned date, he/she should be instructed to take the missed dose immediately and remain on the original weekly schedule.
Slovenian: Če si je bolnik pozabil injicirati abatacept in od predvidenega dneva ni minilo več kot tri dni, si mora pozabljeni odmerek injicirati takoj, nato pa naj nadaljuje z uporabo zdravila po prvotni tedenski shemi.
English: Consistent with the results observed earlier in RA patients, population pharmacokinetic analyses for abatacept in PsA patients revealed that there was a trend toward higher clearance (L/h) of abatacept with increasing body weight.
Slovenian: V skladu s predhodno opaženimi rezultati pri bolnikih z RA, analize populacijske farmakokinetike abatacepta pri bolnikih s PsA kažejo, da obstaja tendenca k večjemu očistku (l/uro) abatacepta z naraščanjem telesne mase.
English: Drug Level
Slovenian: Nivo zdravila
English: ORENCIA contains sodium
Slovenian: Zdravilo ORENCIA vsebuje natrij
English: Studies I, II, III, IV, V, VI, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 646, and 351 adult patients, respectively.
Slovenian: V študijo I je bilo vključenih 339, v študijo II 638, v študijo III 389, v študijo IV 1.441, v študijo V 431, v študijo VI 509, v študijo SC-II 646 in v študijo SC-III 351 odraslih bolnikov.
English: ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.
Slovenian: Zdravilo ORENCIA je, samo ali v kombinaciji z metotreksatom (MTX), indicirano za zdravljenje aktivnega psoriaznega artritisa (PsA) pri odraslih bolnikih z nezadostnim odzivom na predhodno zdravljenje z DMARD, vključno z MTX, pri katerih dodatno sistemsko zdravljenje psoriaznih kožnih sprememb ni potrebno.
English: Do not use the pre-filled syringe if it is dropped after the needle cover is removed.
Slovenian: NE uporabljajte napolnjene injekcijske brizge, če vam po odstranitvi pokrovčka igle pade iz rok.
English: Contact your doctor, nurse, or pharmacist for further instructions.
Slovenian: Za nadaljnja navodila se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: In a pre- and postnatal development study with abatacept in rats, no undesirable effects were observed in pups of dams given abatacept at doses up to 45 mg/kg, representing 3-fold a human 10 mg/kg exposure based on AUC.
Slovenian: V študijah vplivov abatacepta na prenatalni in postnatalni razvoj pri mladičih podgan, ki so prejemale abatacept v odmerkih do 45 mg/kg, kar je na osnovi AUC 3-krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/kg, niso opazili neželenih učinkov.
English: Steady state of abatacept was achieved by day 85 following the weekly body-weight-tiered subcutaneous abatacept dosing.
Slovenian: Pri tedenskem subkutanem odmerjanju abatacepta na osnovi telesne mase je bilo stanje dinamičnega ravnovesja abatacepta doseženo do 85. dneva.
English: Proceed to Step 4
Slovenian: Nadaljujte s 4. korakom.
English: - Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
Slovenian: - Ko se prašek popolnoma raztopi, s pomočjo injekcijske igle iz viale odstranite vso morebiti prisotno peno.
English: ORENCIA 125 mg solution for injection in pre-filled syringe with orange plunger packs of 1, or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of packs of 1, 3, or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Slovenian: ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z oranžnim batom -pakiranje s po 1 ali 4 napolnjenimi injekcijskimi brizgami in skupno pakiranje, ki vsebuje 12 napolnjenih injekcijskih brizg (3 pakiranja po 4).
English: Pack of 1 vial and 1 silicone-free syringe (polyethylene), and multipacks containing 2, or 3 vials and 2, or 3 silicone-free syringes (2 or 3 packs of 1).
Slovenian: Pakiranje z 1 vialo in 1 injekcijsko brizgo brez silikona (polietilen), in skupno pakiranje, ki vsebuje 2 viali in 2 injekcijski brizgi brez silikona ali 3 viale in 3 injekcijske brizge brez silikona (2 ali 3 pakiranja po 1).
English: Check the pre-filled syringe for damage.
Slovenian: Napolnjeno injekcijsko brizgo preglejte glede morebitnih poškodb.
English: Having an infection could put you at risk of serious side effects from ORENCIA.
Slovenian: V primeru okužbe se lahko pojavijo resni neželeni učinki zdravila ORENCIA.
English: Care of injection site:
Slovenian: Nega mesta injiciranja:
English: Needle Cover (cap)
Slovenian: Pokrovček igle (zaporka)
English: The reduction from baseline in mean DAS28 score at day 365 (-3.06) was maintained through day 729 (-3.34) in those patients who continued with abatacept.
Slovenian: Pri bolnikih, ki so nadaljevali zdravljenje z abataceptom, se je zmanjšanje vrednosti povprečne ocene DAS28 od izhodišča do 365. dneva (-3,06) ohranilo do 729. dneva (-3,34).
English: The total content of the pre-filled syringe should be administered as a subcutaneous injection only.
Slovenian: Injicirati je treba celotno vsebino napolnjene injekcijske brizge.
English: Infections were the most commonly reported adverse events in patients with pJIA.
Slovenian: Pri bolnikih s pJIA so bile okužbe najpogostejši sporočeni neželeni učinki.
English: From a 100 mL infusion bag or bottle, withdraw a volume of 0.9% sodium chloride injection equal to the volume of the reconstituted ORENCIA vials.
Slovenian: Iz 100-ml infuzijske vreče ali steklenice odstranite volumen 0,9% raztopine natrijevega klorida (9 mg/ml) za injiciranje, ki je enak volumnu vial po rekonstituciji.
English: The safety of administering live vaccines to infants exposed to abatacept in utero is unknown.
Slovenian: Pri dojenčkih, ki so bili in utero izpostavljeni abataceptu, varnost cepljenja z živimi cepivi ni znana.
English: Uncommon Amenorrhea, menorrhagia
Slovenian: Motnje reprodukcije in dojk občasni amenoreja, menoragija
English: 0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Slovenian: 0,7 ml napolnjena injekcijska brizga (steklo tipa 1) s samodejnim varovalom za iglo in z razširjenim delom za lažji prijem (svetlo moder bat).
English: After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature by waiting 30 minutes, before injecting ORENCIA.
Slovenian: Po vzetju napolnjenega injekcijskega peresnika iz hladilnika, je treba počakati 30 minut, da se zdravilo ORENCIA segreje na sobno temperaturo in ga šele nato injicirati.
English: Studies I, II, III, IV, V, VI, SC-I, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 1371, 646, and 351 adult patients, respectively.
Slovenian: V študijo I je bilo vključenih 339, v študijo II 638, v študijo III 389, v študijo IV 1.441, v študijo V 431, v študijo VI 509, v študijo SC-I 1.371, v študijo SC-II 646 in v študijo SC-III 351 odraslih bolnikov.
English: Do not use the vial if a vacuum is not present.
Slovenian: Če v viali ni vakuuma, viale ne uporabljajte.
English: ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate
Slovenian: Zdravilo ORENCIA se pri zdravljenju psoriaznega artritisa lahko uporablja samo ali v kombinaciji z metotreksatom2.
English: In study PsA-II, the proportion of radiographic non-progressors (≤ 0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with abatacept 125 mg subcutaneous (42.7%) than placebo (32.7%) (10.0 [1.0, 19.1] estimate of difference [95% CI]).
Slovenian: V študiji PsA-II je bil delež bolnikov brez radiografsko evidentnega napredovanja (spremembe od izhodišča ≤ 0) glede na skupno PsA-modificirano oceno SHS na rentgenogramih v 24. tednu večji pri uporabi abatacepta v odmerku 125 mg subkutano (42,7%) kot pri uporabi placeba (32,7%) (10,0 [1,0; 19,1], ocenjena razlika [95% interval zaupanja]).
English: Proceed to Step 3
Slovenian: Nadaljujte s 3. korakom.
English: Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
Slovenian: Ko se prašek popolnoma raztopi, s pomočjo injekcijske igle iz viale odstranite vso morebiti prisotno peno.
English: Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Slovenian: Pred infundiranjem morate ORENCIA raztopino pregledati glede prisotnosti delcev ali spremembe barve.
English: Response Rate
Slovenian: Obseg odziva
English: Proceed to Step 6
Slovenian: Nadaljujte s 6. korakom.
English: During the open-label periods of studies I, II, III, and VI the improvement in physical function has been maintained through 7 years, 5 years, 5 years, and 2 years, respectively.
Slovenian: Izboljšanje fizične funkcije med odprtim obdobjem študije I se je ohranilo 7 let, med odprtim obdobjem študije II 5 let, med odprtim obdobjem študije III 5 let in med odprtim obdobjem študije VI 2 leti.
English: One mL pre-filled syringe (type 1 glass) with flange extenders or one mL pre-filled syringe with an automatic needle safety guard and flange extenders (orange plunger).
Slovenian: 1 ml napolnjena injekcijska brizga (steklo tipa 1) z razširjenim delom za lažji prijem ali 1-ml napolnjena injekcijska brizga s samodejnim varovalom za iglo in z razširjenim delom za lažji prijem (oranžen bat).
English: One hundred and eighty-seven of 3,877 (4.8%) patients developed anti-abatacept antibodies while on treatment.
Slovenian: Med zdravljenjem so se protitelesa proti abataceptu pojavila pri 187 od 3.877 bolnikov (4,8%).
English: ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you do not respond well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'.
Slovenian: Zdravilo ORENCIA uporabljamo za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa, če odziv na zdravljenje z drugimi imunomodulirajočimi zdravili ali zdravljenje z zdravili iz skupine zaviralcev tumorje nekrotizirajočega faktorja (TNF) ni bil zadosten.
English: if you have a severe or uncontrolled infection, do not start treatment with ORENCIA.
Slovenian: - Če imate hudo okužbo, zdravila ORENCIA ne smete uporabljati.
English: In pre-clinical embryo-fetal development studies no undesirable effects were observed at doses up to 29-fold a human 10 mg/kg dose based on AUC.
Slovenian: Pri predkliničnih študijah vplivov na razvoj zarodka/plodu pri odmerkih, ki so bili na osnovi AUC do 29-krat večji od odmerka 10 mg/kg pri človeku, niso opazili neželenih učinkov.
English: There have been reports of non-melanoma skin cancers in patients receiving ORENCIA (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom ORENCIA, so poročali o pojavu nemelanomskih oblik kožnega raka (glejte poglavje 4.8).
English: The use of ORENCIA is not expected to affect the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi zdravilo ORENCIA vplivalo na sposobnost vožnje in upravljanja s stroji.
English: ** p < 0.01, abatacept vs. placebo.
Slovenian: ** p < 0,01, abatacept v primerjavi s placebom.
English: 87.5 mg/0.7 mL Pre-filled Syringe
Slovenian: 87,5 mg/0,7 ml napolnjena injekcijska brizga
English: EU/1/07/389/004 1 pre-filled syringe EU/1/07/389/005 4 pre-filled syringes
Slovenian: EU/1/07/389/004 1 napolnjena injekcijska brizga EU/1/07/389/005 4 napolnjene injekcijske brizge
English: DO NOT remove the orange needle cover until you are ready to inject.
Slovenian: NE odstranjujte oranžnega pokrovčka igle, dokler niste pripravljeni na injiciranje.
English: if you are a woman who could become pregnant, you must use reliable contraception (birth control) while using ORENCIA and up to 14 weeks after the last dose.
Slovenian: Ženske v rodni dobi morajo med uporabo zdravila ORENCIA in še do 14 tednov po uporabi zadnjega odmerka uporabljati učinkovito obliko kontracepcije (preprečevanja nosečnosti).
English: Skin Pinch
Slovenian: Kožna guba
English: ORENCIA Patient Alert Card
Slovenian: ORENCIA - Opozorilna kartica za bolnika
English: In study PsA-II, the proportion of patients with at least ≥ 0.35 decrease from baseline in HAQ-DI was 31.0% with abatacept vs. 23.7% with placebo (7.2 [-1.1, 15.6], estimate of difference [95% CI]).
Slovenian: V študiji PsA-II je delež bolnikov z zmanjšanjem ocene HAQ-DI za najmanj ≥ 0,35 od izhodišča pri uporabi abatacepta znašal 31,0% v primerjavi s 23,7% pri uporabi placeba (7,2 [-1,1; 15,6], ocenjena razlika [95% interval zaupanja]).
English: The syringe should not be shaken.
Slovenian: Injekcijske brizge se ne sme stresati.
English: Improvement in HAQ-DI scores was maintained or improved for up to 1 year with continuing abatacept treatment in both PsA-I and PsA-II studies.
Slovenian: V obeh študijah, študiji PsA-I in študiji PsA-II, se je pri nadaljevanju zdravljenja z abataceptom izboljšanje ocene HAQ-DI ohranilo ali še izboljševalo do 1 leta.
English: ORENCIA is available in packs of 1 vial and 1 silicone-free syringe, and in multipacks containing 2, or 3 vials and 2, or 3 silicone-free syringes (2 or 3 packs of 1).
Slovenian: Zdravilo ORENCIA je na voljo v pakiranjih z 1 vialo in 1 injekcijsko brizgo brez silikona in v skupnih pakiranjih z 2 vialama in 2 injekcijskima brizgama brez silikona ali 3 vialami in 3 injekcijskimi brizgami brez silikona (2 ali 3 pakiranja po 1).
English: 0.4 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (white plunger).
Slovenian: 0,4 ml napolnjena injekcijska brizga (steklo tipa 1) s samodejnim varovalom za iglo in z razširjenim delom za lažji prijem (bel bat).
English: It should be clear and colourless to pale yellow.
Slovenian: Tekočina mora biti bistra in brezbarvna do bledo rumena.
English: Abatacept has been studied in patients with pJIA in two clinical trials (pJIA SC study and pJIA IV study).
Slovenian: Uporabo abatacepta pri bolnikih s pJIA so raziskovali v dveh kliničnih preskušanjih (študija subkutane uporabe pri pJIA in študija intravenske uporabe pri pJIA).