FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not remove the needle cover while allowing the pre-filled syringe to reach room temperature.
Slovenian: Ne odstranjujte pokrovčka igle, medtem, ko čakate, da se napolnjena injekcijska brizga segreje na sobno temperaturo
English: Table 9:
Slovenian: Preglednica 9:
English: Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with pJIA following repeated treatment with intravenous ORENCIA.
Slovenian: Protitelesa proti celotni molekuli abatacepta ali proti CTLA-4 delu abatacepta so pri bolnikih s pJIA po ponavljajočih se intravenskih odmerkih zdravila ORENCIA vrednotili z ELISA testi.
English: A study of open-label intravenous abatacept on a background of nonbiologic DMARDs was conducted in patients with active RA who had an inadequate response to previous (washout for at least 2 months; n=449) or current (no washout period; n=597) TNF-inhibitor therapy (study VII).
Slovenian: Odprta študija intravenskega zdravljenja z abataceptom po osnovnem zdravljenju z nebiološkim imunomodulirajočim protirevmatičnim zdravilom (DMARD) je bila izvedena pri bolnikih z aktivnim RA brez zadostnega odziva po predhodnem (čas izpiranja vsaj 2 meseca; n=449) ali trenutnem (brez obdobja izpiranja; n=597) zdravljenju z zaviralcem TNF (študija VII).
English: You can press a cotton ball or gauze over the injection site.
Slovenian: Na mesto injiciranja lahko pritisnite s kosmom vate ali gazo.
English: Some vaccines should not be given while you are receiving ORENCIA.
Slovenian: Med zdravljenjem z zdravilom ORENCIA nekaterih cepiv ne smete prejeti.
English: No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Slovenian: Pri uporabi abatacepta v kombinaciji s sulfasalazinom, hidroksiklorokinonom ali leflunomidom niso odkrili pomembnejših težav z varnostjo.
English: In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebotreated patients were 1.2% and 0.9%, respectively (see section 4.8).
Slovenian: V s placebom nadzorovanih kliničnih preskušanjih je bila pogostnost novotvorb pri uporabi abatacepta 1,2%, pri uporabi placeba pa 0,9% (glejte poglavje 4.8).
English: After pneumococcal vaccination, 62 of 112 abatacept-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine.
Slovenian: Po cepljenju proti pnevmokokom je bil zadosten imunski odziv, to je vsaj 2-kratno povečanje titrov protiteles proti pnevmokoknemu polisaharidnemu cepivu, dosežen pri 62 od 112 bolnikov, ki so se zdravili z abataceptom.
English: A. Dispose of the used syringe in a Sharps container.
Slovenian: A. Uporabljeno injekcijsko brizgo zavrzite v posodo za odstranjevanje ostrih predmetov.
English: Abatacept in pJIA patients has also been studied with the subcutaneous formulation in children and adolescents with moderate to severe active pJIA, ages 2 to 17 years with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents.
Slovenian: Pri bolnikih s pJIA so raziskovali tudi subkutano uporabo abatacepta, in sicer pri otrocih in mladostnikih z zmerno do hudo aktivnim pJIA, starih od 2 do 17 let, z nezadostnim odzivom ali intoleranco za vsaj enega od imunomodulirajočih protirevmatičnih zdravil, kar je lahko vključevalo tudi biološka zdravila.
English: A study of open-label abatacept on a background of nonbiologic DMARDs was conducted in patients with active RA who had an inadequate response to previous (washout for at least 2 months; n=449) or current (no washout period; n=597) TNF-inhibitor therapy (study VII).
Slovenian: Odprta študija zdravljenja z abataceptom po osnovnem zdravljenju z nebiološkim imunomodulirajočim protirevmatičnim zdravilom (DMARD) je bila izvedena pri bolnikih z aktivnim RA brez zadostnega odziva po predhodnem (čas izpiranja vsaj 2 meseca; n=449) ali trenutnem (brez obdobja izpiranja; n=597) zdravljenju z zaviralcem TNF (študija VII).
English: 50 mg/0.4 mL Pre-filled Syringe
Slovenian: 50 mg/0,4 ml napolnjena injekcijska brizga
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 5.
Slovenian: Zmanjšanje obsega napredovanja strukturnih poškodb z abataceptom/metotreksatom v primerjavi s placebom/metotreksatom po 12 mesecih zdravljenja je prikazano v preglednici 5.
English: Dose Vials
Slovenian: Odmerek Viale
English: DO NOT RECAP the Pre-filled Syringe, as this may damage the needle.
Slovenian: Pokrovčka igle NE NAMEŠČAJTE NAZAJ na napolnjeno injekcijsko brizgo, saj lahko pri tem poškodujete iglo.
English: Sharps containers are special puncture-resistant disposal bins that can be bought at many retail outlets.
Slovenian: Posode za odstranjevanje ostrih predmetov so posebne posode, ki jih ostri predmeti ne morejo preluknjati.
English: ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger pack of 4 pre-filled syringes with needle guard.
Slovenian: ORENCIA 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi z belim batom pakiranje s 4 napolnjenimi injekcijskimi brizgami z varovalom za iglo.
English: Patients who had not achieved at least a 20% improvement from baseline in their swollen and tender joint counts by Week 16 escaped to open-label abatacept 125 mg subcutaneous weekly.
Slovenian: Bolniki, pri katerih se število oteklih ali občutljivih sklepov od izhodišča do 16. tedna ni izboljšalo za vsaj 20 %, so prešli na odprto zdravljenje z abataceptom v odmerku 125 mg subkutano tedensko.
English: ORENCIA powder for concentrate for solution for infusion is used in children and adolescents aged 6 to 17 years when a previous disease-modifying medicine has not worked well enough or is not suitable for them.
Slovenian: Zdravilo ORENCIA prašek za koncentrat za raztopino za infundiranje uporabljamo pri otrocih in mladostnikih, starih od 6 do 17 let, če odziv na predhodno zdravljenje z imunomodulirajočim zdravilom ni bil zadosten ali pa zdravljenje z njim ni bilo primerno.
English: - Do not use the vial if the vacuum is not present.
Slovenian: - Če v viali ni vakuuma, viale ne uporabljajte.
English: ACR 50 Month 3 Month 6 Month 12
Slovenian: ACR 50 3. mesec 6. mesec 12. mesec
English: Do not rub the injection site.
Slovenian: NE drgnite mesta injiciranja.
English: Patients entering the two PsA studies had mild to moderate psoriasis with median PASI scores of 8.6 in PsA-I and 4.5 in PsA-II.
Slovenian: Mediana ocena PASI je v študiji PsA-I znašala 8,6, v študiji PsA-II pa 4,5.
English: Each vial contains 250 mg of abatacept.
Slovenian: Ena viala vsebuje 250 mg abatacepta.
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
Slovenian: ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 87,5 mg abatacepta v 0,7 ml.
English: What you need to know before you are given ORENCIA 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo ORENCIA 3.
English: In placebo-controlled clinical trials, in comparison with patients treated with TNFinhibitors and placebo, patients who received combination TNF-inhibitors with abatacept experienced an increase in overall infections and serious infections (see section 4.5).
Slovenian: V s placebom nadzorovanih kliničnih preskušanjih je bilo število vseh okužb in hudih okužb večje pri bolnikih, ki so prejemali zaviralce TNF v kombinaciji z abataceptom kot pri bolnikih, ki so prejemali zaviralce TNF in placebo (glejte poglavje 4.5).
English: Abatacept therapy did not lead to increased formation of autoantibodies, i.e., antinuclear and antidsDNA antibodies, compared with placebo.
Slovenian: Pri zdravljenju z abataceptom tvorba avtoprotiteles, npr. protijedrna in anti-dsDNA protitelesa, ni bila večja kot pri placebu.
English: PREPARE YOUR CLICKJECT PEN
Slovenian: Samolepilni obliž klik
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 metotreksatom.
English: Under aseptic conditions, reconstitute each vial with 10 mL of water for injections, using the silicone-free disposable syringe provided with each vial (see section 6.2) and an 18-21 gauge needle.
Slovenian: Pri tem uporabite injekcijsko brizgo za enkratno uporabo, ki ne vsebuje silikona in je priložena vsaki viali (glejte poglavje 6.2) in injekcijsko iglo velikosti 18-21.
English: EU/1/07/389/007 1 pre-filled syringe with needle guard EU/1/07/389/008 4 pre-filled syringes with needle guard EU/1/07/389/010 3 pre-filled syringes with needle guard
Slovenian: EU/1/07/389/007 1 napolnjena injekcijska brizga z varovalom za iglo EU/1/07/389/008 4 napolnjene injekcijske brizge z varovalom za iglo EU/1/07/389/010 3 napolnjene injekcijske brizge z varovalom za iglo
English: No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
Slovenian: Pri uporabi skupaj z drugimi imunomodulirajočimi protirevmatičnimi zdravili (DMARDs - diseasemodifying anti-rheumatic drugs), kortikosteroidi, salicilati, nesteroidnimi protivnetnimi zdravili (NSAIDs - nonsteroidal anti-inflammatory drugs) ali analgetiki odmerka ni treba prilagoditi.
English: The use of ORENCIA is not expected to affect the ability to drive, cycle or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi zdravilo ORENCIA vplivalo na sposobnost vožnje, kolesarjenja in upravljanja strojev.
English: ORENCIA can be received with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac.
Slovenian: Zdravilo ORENCIA se lahko prejema skupaj z drugimi zdravili, ki jih pogosto uporabljamo za zdravljenje revmatoidnega artritisa, npr. kortikosteroidi ali zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili, kot sta ibuprofen in diklofenak.
English: Children and adolescents with polyarticular juvenile idiopathic arthritis
Slovenian: Otroci in mladostniki s poliartikularnim juvenilnim idiopatskim artritisom
English: Do not shake.
Slovenian: Ne tresite.
English: Study SC-III: Induction of remission in methotrexate-naive RA patients
Slovenian: Študija SC-III: Indukcija remisije pri bolnikih z RA, ki se še niso zdravili z metotreksatom
English: Proportion (%) of polyarticular JIA patients with ACR responses or inactive disease
Slovenian: Delež (%) bolnikov s poliartikularnim JIA z ACR odzivom ali neaktivno boleznijo konec obdobja A (113. dan)
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 4.
Slovenian: Zmanjšanje obsega napredovanja strukturnih poškodb z abataceptom/metotreksatom v primerjavi s placebom/metotreksatom po 12 mesecih zdravljenja je prikazano v preglednici 4.
English: The frequency of local injection site reactions was 3.8% (12/318) and 9.1% (30/328) at 12 months (p=0.006) and 4.1% (13/318) and 10.4% (34/328) at 24 months for abatacept SC and adalimumab SC, respectively.
Slovenian: Pogostnost reakcij na mestu injiciranja v 12 mesecih je pri uporabi abatacepta s.c. bila 3,8 % (12/318), pri uporabi adalimumaba s.c. pa 9,1 % (30/328) (p=0,006), v 24 mesecih pa je pri uporabi abatacepta s.c. bila 4,1 % (13/318), pri uporabi adalimumaba s.c. pa 10,4 % (34/328).
English: Gently clean injection site with an alcohol swab and let your skin dry.
Slovenian: Mesto injiciranja nežno očistite z alkoholnim zložencem in počakajte, da se koža posuši.
English: ORENCIA can be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac.
Slovenian: Zdravilo ORENCIA se lahko uporablja skupaj z drugimi zdravili, ki jih pogosto uporabljamo za zdravljenje revmatoidnega artritisa, npr. kortikosteroidi ali zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili, kot sta ibuprofen in diklofenak.
English: Don't use the syringe if it is dropped without the needle cover in place.
Slovenian: Brizge ne smete uporabiti, če vam je padla iz rok brez nameščenega pokrovčka igle.
English: DO NOT RECAP the pre-filled syringe at any time, as this may damage, bend, or break the needle.
Slovenian: Pokrovčka igle nikoli NE NAMEŠČAJTE NAZAJ na napolnjeno injekcijsko brizgo, saj lahko pri tem poškodujete, zvijete ali zlomite iglo.
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children 2 years of age and older.
Slovenian: Zdravilo ORENCIA uporabljamo za zdravljenje revmatoidnega artritisa in psoriaznega artritisa pri odraslih, ter poliartikularnega juvenilnega idiopatskega artritisa pri otrocih, starih 2 leti in starejših.
English: Discontinuation due to an acute infusion-related reaction occurred in 0.3% of patients receiving abatacept and in 0.1% of placebo-treated patients.
Slovenian: Zaradi akutnih neželenih učinkov, povezanih z infundiranjem, je bilo zdravljenje prekinjeno pri 0,3% bolnikov, ki so prejemali abatacept in 0,1% bolnikov, ki so prejemali placebo.
English: The primary endpoint showed noninferiority (predefined margin of 12%) of ACR 20 response after 12 months of treatment, 64.8% (206/318) for the abatacept SC group and 63.4% (208/328) for the adalimumab SC group; treatment difference was 1.8% [95% confidence interval (CI): -5.6, 9.2], with comparable responses throughout the 24-month period.
Slovenian: Primarni cilj je pokazal neinferiornost (vnaprej določena meja 12 %) odziva ACR 20 po 12 mesecih zdravljenja, ki je bil v skupini z abataceptom s.c. dosežen pri 64,8 % (206/318) bolnikov, v skupini z adalimumabom s.c. pa pri 63,4 % (208/328); razlika zdravljenja je bila 1,8 % [95 % interval zaupanja (IZ): 5,6; 9,2], odzivi v celotnem 24-mesečnem obdobju pa so bili primerljivi.
English: One patient was diagnosed with multiple sclerosis while in the extension period of the pJIA IV study.
Slovenian: Pri enem bolniku je bila v podaljšanem obdobju študije i.v.
English: 50 mg/0.4 mL: white Plunger
Slovenian: 50 mg/0,4 ml: bel bat
English: Proceed to Step 5
Slovenian: Nadaljujte s 5. korakom.
English: Higher ACR 20 responses were observed with abatacept vs placebo regardless of prior TNF-inhibitor treatment in both studies.
Slovenian: V obeh študijah so bili večji odzivi ACR 20 opaženi pri uporabi abatacepta v primerjavi s placebom ne glede na predhodno zdravljenje z zaviralcem TNF.
English: A randomised and double-blinded study evaluated abatacept SC in combination with methotrexate (abatacept + MTX), abatacept SC monotherapy, or methotrexate monotherapy (MTX group) in induction of remission following 12 months of treatment, and maintenance of drug-free remission after complete drug withdrawal in MTX-naive adult patients with highly active early rheumatoid arthritis with poor prognostic factors.
Slovenian: V randomizirani, dvojno slepi študiji so vrednotili subkutano (s.c.) uporabo abatacepta v kombinaciji z metotreksatom (abatacept + MTX), subkutano uporabo abatacepta v monoterapiji ali uporabo metotreksata v monoterapiji (skupina z MTX) pri indukciji remisije po 12-mesečnem zdravljenju in ohranitev remisije v času brez uporabe zdravila po popolni odtegnitvi zdravila pri odraslih bolnikih z močno aktivnim zgodnjim revmatoidnim artritisom s slabimi prognostičnimi dejavniki, ki se predhodno še niso zdravili z MTX.
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children 6 years of age and older.
Slovenian: Zdravilo ORENCIA uporabljamo za zdravljenje revmatoidnega artritisa in psoriaznega artritisa pri odraslih, ter poliartikularnega juvenilnega idiopatskega artritisa pri otrocih, starih 6 let in starejših.
English: Population pharmacokinetic analyses revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
Slovenian: Analize populacijske farmakokinetike kažejo tendenco povečevanja očistka abatacepta s povečevanjem telesne mase.
English: Before you start - some Do's and Don'ts Do
Slovenian: Preden začnete - nekaj stvari na katere morate biti še posebej pozorni Vedno morate
English: Wait
Slovenian: Počakajte
English: The other ingredients are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections (see section 2 "ORENCIA contains sodium").
Slovenian: Druge sestavine zdravila so saharoza, poloksamer 188, natrijev dihidrogenfosfat monohidrat, brezvodni natrijev hidrogenfosfat in voda za injekcije (glejte poglavje 2 "Zdravilo ORENCIA vsebuje natrij").
English: Injection Reactions in adult patients treated with subcutaneous abatacept
Slovenian: Reakcije na injiciranje pri odraslih bolnikih, ki so se z abataceptom zdravili subkutano
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate anhydrous Water for injections
Slovenian: natrijev dihidrogenfosfat monohidrat brezvodni natrijev hidrogenfosfat voda za injekcije
English: Concomitant medication, such as methotrexate, corticosteroids, and NSAIDs, did not influence abatacept apparent clearance.
Slovenian: Sočasna uporaba zdravil, kot so metotreksat, kortikosteroidi in nesteroidna protivnetna zdravila, ni vplivala na navidezni očistek abatacepta.
English: In study SC-III, similar immunogenicity rates were seen in patients on treatment for the abatacept+MTX, and abatacept monotherapy groups (2.9% (3/103) and 5.0% (5/101), respectively) during the double-blind 12 month period.
Slovenian: V študiji SC-III so med dvojno slepim 12-mesečnim obdobjem zdravljenja pri bolnikih, ki so se zdravili z abataceptom+MTX, in bolnikih, ki so se zdravili z abataceptom v monoterapiji, poročali o podobnih deležih imunogenosti (2,9 % (3/103) in 5,0 % (5/101)).
English: No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/kg at monthly intervals in rheumatoid arthritis patients.
Slovenian: Pri kontinuiranem ponavljajočem se zdravljenju z odmerkom 10 mg/kg v mesečnih intervalih pri bolnikih z revmatoidnim artritisom ni prihajalo do sistemskega kopičenja abatacepta.
English: Serious infections, including sepsis and pneumonia, have been reported with abatacept (see section 4.8).
Slovenian: Pri uporabi abatacepta so poročali o pojavu resnih okužb, vključno s sepso in pljučnico (glejte poglavje 4.8).
English: Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 87,5 mg abatacepta v 0,7 ml.
English: Wipe the injection site with an alcohol swab and let your skin dry.
Slovenian: Mesto injiciranja obrišite z alkoholnim zložencem in počakajte, da se koža posuši.
English: *** p < 0.001, abatacept vs. placebo.
Slovenian: *** p < 0,001, abatacept v primerjavi s placebom.
English: ORENCIA SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight (see section 5.1).
Slovenian: Zdravilo ORENCIA za subkutano uporabo je treba uporabljati tedensko v odmerku 125 mg abatacepta v obliki subkutane injekcije, ne glede na telesno maso (glejte poglavje 5.1).
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe with light blue plunger pack of 4 pre-filled syringes with needle guard.
Slovenian: ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi s svetlomodrim batom pakiranje s 4 napolnjenimi injekcijskimi brizgami z varovalom za iglo.
English: Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections.
Slovenian: Številne resne okužbe so se pojavile pri bolnikih, ki so se sočasno zdravili z zdravili za zaviranje imunske odzivnosti.
English: ORENCIA SC should be administered weekly at a dose of 125 mg by subcutaneous injection regardless of weight (see section 5.1).
Slovenian: Zdravilo ORENCIA za subkutano uporabo je treba uporabljati tedensko v odmerku 125 mg v obliki subkutane injekcije, ne glede na telesno maso (glejte poglavje 5.1).
English: Psoriatic arthritis
Slovenian: Psoriazni artritis
English: Fatigue, asthenia Uncommon Influenza like illness, weight increased
Slovenian: občasni gripi podobna bolezen, povečanje telesne mase
English: Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening.
Slovenian: Po prvem infundiranju zdravila se lahko pojavi anafilaksija ali anafilaktoidne reakcije, ki so lahko smrtno nevarne.
English: A. Remove the needle cover (cap) only when you are ready to administer the injection.
Slovenian: A. Pokrovček igle (zaporko) odstranite šele, ko ste pripravljeni na injiciranje zdravila.
English: ORENCIA 125 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 125 mg of abatacept in one mL.
Slovenian: ORENCIA 125 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 125 mg abatacepta v enem ml.
English: In the smaller study PsA-I, the ACR 20 responses with abatacept 10 mg/kg intravenous vs placebo in patients who were TNF inhibitor-naive were 55.6% vs 20.0%, respectively, and in patients who were TNF inhibitorexperienced were 30.8% vs 16.7%, respectively.
Slovenian: V manjši študiji PsA-I je odziv ACR 20 pri uporabi abatacepta v odmerku 10 mg/kg intravensko pri bolnikih, ki se predhodno niso zdravili z zaviralcem TNF, znašal 55,6%, pri uporabi placeba pa 20,0%.
English: Lower respiratory tract infection (including bronchitis), urinary tract infection, herpes infections (including herpes simplex, oral herpes, and herpes zoster), pneumonia, influenza Uncommon Tooth infection, onychomycosis, sepsis, muskuloskeletal infections, skin abscess, pyelonephritis, rhinitis, ear infection
Slovenian: pogosti okužba spodnjih dihal (vključno z bronhitisom), okužba sečil, okužbe z virusom herpes (vključno s herpesom simpleksom, herpesom ustne votline in žrela ter herpesom zostrom), pljučnica, gripa občasni okužba zoba, onihomikoza, sepsa, mišičnoskeletne okužbe, absces na koži, pielonefritis, rinitis, okužba ušesa redki tuberkuloza, bakteriemija, okužbe v prebavilih, vnetna bolezen v medenični votlini
English: Administration: when reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Slovenian: Aplikacija: če sta rekonstitucija in redčenje izvedena v aseptičnih pogojih, se ORENCIA raztopino za infundiranje lahko uporabi takoj ali v 24 urah, če se jo shrani pri temperaturi od 2°C do 8°C, vendar pa jo je iz mikrobioloških razlogov bolje uporabiti takoj.
English: INJECT YOUR DOSE
Slovenian: INJICIRANJE ODMERKA
English: DAS28-Remission a Odds Ratio (95% CI) vs. MTX P value
Slovenian: DAS28-remisijaa Razmerje obetov (95 % IZ) v primerjavi z MTX P vrednost
English: Abatacept SC+ MTX n = 119
Slovenian: Abatacept s.c.+ MTX n = 119
English: The adjusted mean changes (standard error; SE) from baseline in DAS28-CRP were2.35 (SE 0.08) [95% CI: -2.51, -2.19] and -2.33 (SE 0.08) [95% CI: -2.50, -2.17] in the SC abatacept group and the adalimumab group, respectively, at 24 months, with similar changes over time.
Slovenian: Prilagojena srednja razlika (standardna napaka; SN) DAS28-CRP od izhodišča do 24. meseca je v skupini z abataceptom s.c. znašala -2,35 (SN 0,08) [95 % IZ: -2,51;2,19], v skupini z adalimumabom s.c. pa -2,33 (SN 0,08) [95 % IZ: -2,50; -2,17], spremembe tekom časa pa so bile podobne.