natgillin/translations-raw huggingface dataset:
Children and adolescents with moderate to severe active pJIA, ages 6 to 17 years with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents, were enrolled.
V študijo so bili vključeni otroci in mladostniki z zmernim do hudim aktivnim pJIA, stari od 6 do 17 let, z nezadostnim odzivom ali intoleranco na zdravljenje vsaj z enim od imunomodulirajočih protirevmatičnih zdravil, ki so lahko vključevala tudi biološka zdravila.
The adjusted geometric mean of abatacept at steady state trough concentration (Cminss) was 25.3 mcg/mL for the subcutaneous pre-filled pen and 27.8 mcg/mL for the subcutaneous pre-filled syringe with a ratio of 0.91 [90% CI: 0.83, 1.00].
Pri subkutani uporabi napolnjenega injekcijskega peresnika je prilagojena geometrijska srednja najmanjša koncentracija abatacepta v stanju dinamičnega ravnovesja (Cminss) znašala 25,3 µg/ml, pri subkutani uporabi napolnjene injekcijske brizge pa 27,8 µg/ml z razmerjem 0,91 [90 % interval zaupanja: 0,83; 1,00].
Study SC-I compared the immunogenicity to abatacept following subcutaneous or intravenous administration as assessed by ELISA assay.
V študiji SC-I so z ELISA testom primerjali imunogenost abatacepta po subkutani ali intravenski uporabi.
Common (may affect up to 1 in 10 people): upper airway infection (including infections of nose, sinus and throat) fever
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): okužbe zgornjih dihal (vključno z okužbami nosu, sinusov in žrela), zvišana telesna temperatura.
Gently clean injection site
Mesto injiciranja nežno očistite
Total Sharp score Erosion score JSN score a Based on non-parametric analysis.
Ocena zožitve sklepne špranje a Na osnovi neparametrične analize.
No increase of tuberculosis was observed in the pivotal placebo-controlled studies; however, all ORENCIA patients were screened for tuberculosis.
V ključnih s placebom nadzorovanih kliničnih študijah niso opazili večje pojavnosti tuberkuloze.
Psoriatic arthritis Adults
Psoriazni artritis Odrasli
ORENCIA is usually used in combination with methotrexate, although ORENCIA may also be used alone in case of intolerance to methotrexate or 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 bolnik metotreksata ne prenaša ali zdravljenje z njim za bolnika ni primerno
Do not fan or blow on the clean area.
Na očiščeno mesto ne smete pihati.
Two serious infections (varicella and sepsis) were reported during the initial 4 months of treatment with abatacept.
Med uvodnimi 4 meseci zdravljenja z abataceptom so poročali o dveh resnih okužbah (norice in sepsa).
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Dokazano je bilo, da kombinirano zdravljenje z abataceptom in metotreksatom zmanjša napredovanje poškodb sklepov in izboljša fizično funkcijo.
They had active disease, with baseline mean active joint count of 16 and a mean number of joints with loss of motion of 16; and elevated C-reactive protein (CRP) levels (mean, 3.2 mg/dl) and ESRs (mean, 32 mm/h).
V izhodišču so imeli aktivno bolezen s srednjo vrednostjo aktivnega števila sklepov 16, srednjo vrednostjo števila sklepov z omejeno gibljivostjo 16, zvišano vrednost C reaktivnega proteina (CRP) (srednja vrednost 3,2 mg/dl) in zvišano vrednost sedimentacije eritrocitov (srednja vrednost 32 mm/uro).
The most frequently reported organ cancer in the placebo-controlled clinical trials was lung cancer 0.17 (0.05, 0.43) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients, and 0.12 (0.08, 0.17) per 100 patient-years in the cumulative period.
V s placebom nadzorovanih kliničnih preskušanjih je bila najpogostejša oblika raka na organih rak pljuč; 0,17 (0,05; 0,43) na 100 bolnik-let pri bolnikih, ki so prejemali abatacept, 0 pri bolnikih, ki so prejemali placebo, in 0,12 (0,08; 0,17) na 100 bolnik-let v kumulativnem obdobju.
Month 12 57%‡
3. mesec 40%‡ 6. mesec 53%‡ 12. mesec 57%‡
The 125 mg/mL pre-filled syringe is shown below.
V nadaljevanju je predstavljena napolnjena injekcijska brizga 125 mg/ml.
In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary gland tumours (in females) occurred.
V študijah kancerogenega potenciala so pri miših opazili večjo pojavnost limfomov in tumorjev mlečne žleze (pri samicah).
EU/1/07/389/006 12 pre-filled syringes (3 packs of 4)
EU/1/07/389/006 12 napolnjenih injekcijskih brizg (3 pakiranja po 4)
In study PsA-II, the proportion of patients who achieved PASI 50 response was 26.7% with abatacept vs. 19.6% with placebo (7.3 [-2.2, 16.7], estimate of difference [95% CI]), and the proportion of patients who achieved PASI 75 response was 16.4% with abatacept vs. 10.1% with placebo (6.4 [-1.3, 14.1], estimate of difference [95% CI]).
V študiji PsA-II je delež bolnikov z doseženim odzivom PASI 50 pri uporabi abatacepta znašal 26,7% v primerjavi z 19,6% pri uporabi placeba (7,3 [-2,2; 16,7], ocenjena razlika [95% interval zaupanja]), delež bolnikov z doseženim odzivom PASI 75 pa je pri uporabi abatacepta znašal 16,4% v primerjavi z 10,1% pri uporabi placeba (6,4 [-1,3; 14,1], ocenjena razlika [95% interval zaupanja]).
Rash (including dermatitis)
Bolezni kože in podkožja pogosti izpuščaj (vključno z dermatitisom)
In the cumulative period 7,044 patients treated with abatacept during 21,011 patient-years (of which over 1,000 were treated with abatacept for over 5 years), the incidence rate of malignancy was 1.2 (1.1, 1.4) per 100 patient-years, and the annualised incidence rates remained stable.
V kumulativnem obdobju se je 7.044 bolnikov z abataceptom zdravilo 21.011 bolnik-let (od katerih se jih je več kot 1.000 z abataceptom zdravilo več kot 5 let).
A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
V s placebom nadzorovanih kliničnih preskušanjih je abatacept prejemalo skupaj 404 bolnikov, starih 65 let in starejših, vključno s 67 bolniki, starimi 75 let in starejšimi.
Abatacept has been studied in patients with pJIA in 2 clinical trials (ongoing pJIA SC study and pJIA IV study).
Uporabo abatacepta pri bolnikih s pJIA so raziskovali v 2 kliničnih preskušanjih (študija subkutane uporabe pri pJIA, ki še poteka, in študija intravenske uporabe pri pJIA).
ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNFblockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.
Zdravila ORENCIA se ne sme uporabljati skupaj z biološkimi zdravili za zdravljenje revmatoidnega artritisa, vključno z zaviralci TNF, kot so adalimumab, etanercept in infliksimab.
Press a cotton ball over the injection site and hold for 10 seconds.
Na mesto injiciranja za 10 sekund pritisnite s kosmom vate.
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 6 years of age and older who have had an inadequate response to previous DMARD therapy.
Zdravilo ORENCIA je v kombinaciji z metotreksatom indicirano za zdravljenje zmernega do hudega aktivnega poliartikularnega juvenilnega idiopatskega artritisa (pJIA) pri pediatričnih bolnikih, starih 6 let in starejših, z nezadostnim odzivom na predhodno zdravljenje z DMARD.
Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.
Pomožne snovi: saharoza, poloksamer 188, natrijev dihidrogenfosfat monohidrat, brezvodni natrijev hidrogenfosfat, voda za injekcije.
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy.
Zdravilo ORENCIA je v kombinaciji z metotreksatom indicirano za zdravljenje zmernega do hudega aktivnega poliartikularnega juvenilnega idiopatskega artritisa (pJIA) pri pediatričnih bolnikih, starih 2 leti in starejših, z nezadostnim odzivom na predhodno zdravljenje z DMARD.
During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 4%, respectively, and were consistent with the types of reactions reported in adults.
Pogostnost akutnih, z infundiranjem povezanih reakcij, je bila med obdobjem A študije 4%, med obdobjem B 2% in med obdobjem C 4%.
ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.
Za zdravljenje močno aktivnega in napredujočega revmatoidnega artritisa se lahko zdravilo ORENCIA skupaj z metotreksatom uporablja tudi brez predhodnega zdravljenja z metotreksatom.
The frequencies of serious infection and malignancy relative to placebo among intravenous abatacept-treated patients over age 65 were higher than among those under age 65.
V primerjavi s placebom je bila pri intravenskem zdravljenju z abataceptom pogostnost hudih okužb in novotvorb pri bolnikih, starejših od 65 let, večja kot pri bolnikih, mlajših od 65 let.
In study VI, statistically significant improvement in the ACR 20 response in abatacept plus methotrexate-treated patients versus methotrexate plus placebo-treated patients was observed at 29 days, and was maintained through the duration of the study.
V študiji VI so 29. dan opazili statistično pomembno izboljšanje odziva ACR 20 pri bolnikih, ki so se zdravili z abataceptom v kombinaciji z metotreksatom v primerjavi z bolniki, ki so prejemali metotreksat in placebo.
ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose.
Subkutano (s.c.) zdravljenje z zdravilom ORENCIA se lahko uvede z intravenskim (i.v.)
Overall, there was no apparent correlation of antibody development to clinical response or adverse events.
Med razvojem protiteles in kliničnim odzivom, neželenimi učinki ali farmakokinetiko ni bilo očitne povezave.
Proceed to Step 2
Nadaljujte z 2. korakom.
Common adverse reactions: pyrexia Uncommon adverse reactions: haematuria, otitis (media and externa).
Pogosti neželeni učinki: zvišana telesna temperatura Občasni neželeni učinki: hematurija, vnetje ušesa (srednjega in zunanjega).
Uncommon Basal cell carcinoma, skin papilloma Rare
občasni karcinom bazalnih celic, papilom kože redki limfom, pljučni rak, karcinom ploščatih celic
The mean (range) trough concentration of abatacept at day 113 was 46.2 mcg/mL (13.4 to 96.2 mcg/mL), 48.0 mcg/mL (22.4 to 122.1 mcg/mL), and 38.5 mcg/mL (9.3 to 73.2 mcg/mL) in paediatric pJIA patients weighing 10 to <25 kg, 25 to <50 kg, and ≥50 kg, respectively.
Na 113. dan je srednja (razpon) najmanjša koncentracija abatacepta pri pediatričnih bolnikih s pJIA s telesno maso od 10 do < 25 kg znašala 46,2 μg/ml (13,4 do 96,2 μg/ml), pri pediatričnih bolnikih s pJIA s telesno maso od 25 do < 50 kg 48,0 μg/ml (22,4 do 122,1 μg/ml), pri pediatričnih bolnikih s pJIA s telesno maso > 50 kg pa 38,5 μg/ml (9,3 do 73,2 μg/ml).
The recommended dose of ORENCIA for patients 6 to 17 years of age with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient's body weight at each administration.
Priporočeni odmerek zdravila ORENCIA pri bolnikih, starih od 6 do 17 let, s poliartikularnim juvenilnim idiopatskim artritisom in telesno maso, manjšo od 75 kg, je 10 mg/kg.
- You should be screened for certain infections prior to treatment with ORENCIA.
- Pred začetkom zdravljenja z zdravilom ORENCIA je treba izvesti preiskave na nekatere okužbe.
You should not be given ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).
Zdravila ORENCIA ne smete prejeti: 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.
If a single IV infusion is given to initiate treatment (IV loading dose before SC administration), the first 125 mg abatacept SC should be administered within a day of the IV infusion, followed by the weekly 125 mg abatacept SC injections (for the posology of the intravenous loading dose, please refer to section 4.2 of ORENCIA 250 mg powder for concentrate for solution for infusion).
odmerek, nato pa sledijo subkutane injekcije abatacepta v odmerku 125 mg enkrat na teden (za odmerjanje intravenskega polnilnega odmerka glejte poglavje 4.2 povzetka glavnih značilnosti zdravila ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje).
Serious adverse reactions were reported in 3.5% (11/318) and 6.1% (20/328) of the respective group.
O resnih neželenih učinkih so poročali pri 3,5 % (11/318) bolnikov, ki so se zdravili z abataceptom, in 6,1 % (20/328) bolnikov, ki so se zdravili z adalimumabom.
You can discard the cap in your household waste after the injection.
Po injiciranju lahko pokrovček zavržete med gospodinjske odpadke.
A significantly higher proportion of patients achieved an ACR 20 response after treatment with abatacept 10 mg/kg intravenous in PsA-I or 125 mg subcutaneous in PsA-II compared to placebo at Week 24 in the overall study populations.
V celotni študijski populaciji je bil v 24. tednu delež bolnikov z odzivom ACR 20 pomembno večji pri zdravljenju z abataceptom v odmerku 10 mg/kg intravensko v študiji PsA-I ali 125 mg subkutano v študiji PsA-II v primerjavi s placebom.
In study PsA-I, the proportion of patients with ≥ 0.30 decrease from baseline in HAQ-DI score was 45.0% with intravenous abatacept vs 19.0% with placebo (26.1 [6.8, 45.5], estimate of difference [95% CI]) at Week 24.
V študiji PsA-I je v 24. tednu delež bolnikov z zmanjšanjem ocene HAQ-DI za ≥ 0,30 od izhodišča pri uporabi abatacepta intravensko znašal 45,0% v primerjavi z 19,0% pri uporabi placeba (26,1 [6,8; 45,5], ocenjena razlika [95% interval zaupanja]).
The incidence rates (95% CI) for serious infections was 3.0 (2.3, 3.8) per 100 patient-years for abatacept-treated patients and 2.3 (1.5, 3.3) per 100 patient-years for placebo-treated patients in the double-blind studies.
Pri bolnikih, ki so v dvojno slepih študijah prejemali abatacept, je stopnja pojavnosti (95% interval zaupanja) resnih okužb znašala 3,0 (2,3; 3,8) na 100 bolnik-let, pri bolnikih, ki so prejemali placebo, pa 2,3 (1,5; 3,3) na 100 bolnik-let.
Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA.
Protirevmatična zdravljenja so bila povezana z reaktivacijo hepatitisa B. Pred uvedbo zdravljenja z zdravilom ORENCIA je treba izvesti presejalne teste za virusni hepatitis v skladu z objavljenimi smernicami.
Postmarketing reports of systemic injection reactions (e.g. pruritus, throat tightness, dyspnea) have been received following the use of subcutaneous ORENCIA.
Po prihodu zdravila na trg so po uporabi zdravila ORENCIA v obliki subkutane injekcije poročali o sistemskih reakcijah na injiciranje (npr. srbenje, stiskanje v grlu, dispneja).
At 12 months, the incidence of AE of infections were 59.6% (93), 68.5% (113), and the incidence of serious AE of infections were 1.9% (3) and 8.5% (14) for abatacept and infliximab groups, respectively.
Po 12-ih mesecih je bila pojavnost okužb kot neželenega učinka v skupini z abataceptom 59,6% (93) in v skupini z infliksimabom 68,5% (113).
ORENCIA is used to: slow down the damage to your joints improve your physical function
Zdravilo ORENCIA uporabljamo za: upočasnitev napredovanja poškodb sklepov, izboljšanje telesne zmogljivosti,
Headache, dizziness Uncommon Migraine, paraesthesia
Bolezni živčevja pogosti glavobol, omotica občasni migrena, parestezija
Viewing Window
Prozorna konica
The most common hematologic malignancy was lymphoma 0.04 (0, 0.24) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients, and 0.06 (0.03, 0.1) per 100 patient-years in the cumulative period.
Najpogostejša hematološka oblika raka je bil limfom; 0,04 (0; 0,24) na 100 bolnik-let pri bolnikih, ki so prejemali abatacept, 0 pri bolnikih, ki so prejemali placebo, in 0,06 (0,03; 0,1) na 100 bolnik-let v kumulativnem obdobju.
Adhesive plaster
Samolepilni obliž
The most frequently reported malignancy in the placebo-controlled clinical trials was non-melanoma skin cancer; 0.6 (0.3, 1.0) per 100 patient-years for abatacept-treated patients and 0.4 (0.1, 0.9) per 100 patient-years for placebo-treated patients and 0.5 (0.4, 0.6) per 100 patient-years in the cumulative period.
V s placebom nadzorovanih kliničnih preskušanjih je bila najpogostejša novotvorba nemelanomski kožni rak; 0,6 (0,3; 1,0) na 100 bolnik-let pri bolnikih, ki so prejemali abatacept, 0,4 (0,1; 0,9) na 100 bolnik-let pri bolnikih, ki so prejemali placebo, in 0,5 (0,4; 0,6) na 100 bolnik-let v kumulativnem obdobju.
Overall, 6.9% (15/218) of subjects (cohorts combined) had a positive immunogenicity response relative to baseline during the cumulative period, including the 4-month short-term treatment period, 20-month extension treatment period and the 6-month post abatacept follow-up period.
V primerjavi z izhodiščem je bil pozitiven imunogenski odziv v kumulativnem obdobju, vključno s 4-mesečnim kratkoročnim obdobjem zdravljenja, 20-mesečnim podaljšanim obdobjem zdravljenja in 6-mesečnim obdobjem spremljanja po uporabi abatacepta prisoten pri 6,9 % vseh oseb (15/218) (kombinirane kohorte).
Most randomised Period B patients entered Period C (58/60 Period B abatacept recipients; 59/62 Period B placebo recipients), as did 36 of the 47 Period A non-responders (n=153 total patients).
Večina bolnikov, ki je bila randomizirana v obdobju B, je bila vključena v obdobje C študije (58/60 bolnikov, ki so v obdobju B prejemali abatacept; 59/62 bolnikov, ki so v obdobju B prejemali placebo).
Each pre-filled syringe contains 125 mg of abatacept in one mL.
Ena napolnjena injekcijska brizga vsebuje 125 mg abatacepta v enem ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AS INTERMEDIATE PACK (WITHOUT BLUE BOX) 1.
ŠKATLA ZA VMESNO PAKIRANJE (NE VKLJUČUJE MODREGA OKENCA) 1.
In study PsA-I, 170 patients received placebo or abatacept intravenously on day 1, 15, 29, and then every 28 days thereafter in a double blind manner for 24 weeks, followed by open-label abatacept 10 mg/kg intravenously every 28 days.
V študiji PsA-I je 170 bolnikov prejemalo placebo ali abatacept intravensko , in sicer na 1., 15. in 29. dan, nato pa 24 tednov na vsakih 28 dni na dvojno slep način.
The incidence rates for malignancies was 1.3 (0.9, 1.9) per 100 patient-years for abatacept-treated patients and 1.1 (0.6, 1.9) per 100 patient-years for placebo-treated patients.
ki so prejemali abatacept, je stopnja pojavnosti novotvorb znašala 1,3 (0,9; 1,9) na 100 bolnik-let, pri bolnikih, ki so prejemali placebo, pa 1,1 (0,6; 1,9) na 100 bolnik-let.
The percent of patients achieving ACR 20, 50, or 70 responses at the recommended abatacept dose in studies PsA-I (10 mg/kg intravenous) and PsA-II (125 mg subcutaneous) are presented in Table 8 below.
Odstotek bolnikov z doseženimi odzivi ACR 20, 50 ali 70 pri uporabi priporočenega odmerka abatacepta v študiji PsA-I (10 mg/kg intravensko) in študiji PsA-II (125 mg subkutano) je prikazan v preglednici 8 v nadaljevanju.
Needle guard
Varovalo za iglo
Don't remove the needle cover until you are ready to inject ORENCIA.
Pokrovčka igle ne smete odstraniti, dokler niste pripravljeni na injiciranje zdravila ORENCIA.
Most recent:
Zadnje zdravljenje:
Please refer to the ORENCIA powder for concentrate for solution for infusion 250 mg and ORENCIA solution for injection in prefilled syringe 125 mg, 87.5 mg and 50 mg SmPCs.
Glejte povzetke glavnih značilnosti zdravila ORENCIA 250 mg prašek za koncentrat za raztopino za infundiranje ter ORENCIA 125 mg, 87,5 mg in 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi.
The frequencies of serious infection and malignancy relative to placebo among abatacept-treated patients over age 65 were higher than among those under age 65.
V primerjavi s placebom je bila pri zdravljenju z abataceptom pogostnost hudih okužb in novotvorb pri bolnikih, starejših od 65 let, večja kot pri bolnikih, mlajših od 65 let.
The percent of patients achieving ACR 20, 50, or 70 responses at the recommended abatacept dose in studies PsA-I (10 mg/kg intravenous) and PsA-II (125 mg subcutaneous) are presented in Table 7 below.
Odstotek bolnikov z doseženimi odzivi ACR 20, 50 ali 70 pri uporabi priporočenega odmerka abatacepta v študiji PsA-I (10 mg/kg intravensko) in študiji PsA-II (125 mg subkutano) je prikazan v preglednici 7 v nadaljevanju.
The mean (range) for cmin and cmax at steady state observed after 85 days of treatment was 32.5 mcg/mL (6.6 to 113.8 mcg/mL) and 48.1 mcg/mL (9.8 to 132.4 mcg/mL), respectively.
Po 85 dneh zdravljenja je srednja vrednost (razpon) cmin v stanju dinamičnega ravnovesja znašala 32,5 μg/ml (6,6-113,8 μg/ml), srednja vrednost (razpon) cmax v stanju dinamičnega ravnovesja pa 48,1 μg/ml (9,8-132,4 μg/ml).
Write down the date, time, and specific part of your body where you injected yourself.
B. Vodite evidenco o injiciranju zdravila Zapišite si datum, čas in predel telesa, kamor ste si vbrizgali zdravilo.
Table 1: Weekly dose of ORENCIA Body weight of patient
Preglednica 1: Tedenski odmerek zdravila ORENCIA Telesna masa bolnika Odmerek 10 kg do manj kot 25 kg
Flange extender
Razširjeno držalo za prsta
At 6 months, the incidence of AE of infections were 48.1% (75), 52.1% (86), and 51.8% (57) and the incidence of serious AE of infections were 1.3% (2), 4.2% (7), and 2.7% (3) for abatacept, infliximab and placebo groups, respectively.
Po 6 mesecih je bila pojavnost okužb kot neželenega učinka v skupini z abataceptom 48,1% (75), v skupini z infliksimabom 52,1% (86) in v skupini s placebom 51,8% (57).
DO NOT remove the needle cover until you are ready to inject.
NE odstranjujte pokrovčka igle, dokler niste pripravljeni na injiciranje.
ORENCIA 87.5 mg solution for injection in pre-filled syringe
ORENCIA 87,5 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
The effects of ORENCIA in pregnancy are not known, so you should not be given ORENCIA if you are pregnant unless your doctor specifically recommends it.
Zdravila ORENCIA med nosečnostjo ne smete prejeti, razen če vam je tako izrecno svetoval zdravnik.
Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections.
Pomožne snovi: saharoza, poloksamer 188, natrijev dihidrogenfosfat monohidrat, brezvodni natrijev hidrogenfosfat in voda za injekcije.
The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), study VI (methotrexate-naive patients), and study SC-I (subcutaneous abatacept) are shown in Table 2.
Odstotek odzivov ACR 20, 50 in 70 pri bolnikih, ki so prejemali abatacept v študiji II (bolniki z nezadostnim odzivom na metotreksat), študiji III (bolniki z nezadostnim odzivom na zaviralec TNF), študiji VI (bolniki, ki se predhodno še niso zdravili z metotreksatom) in študiji SC-I (subkutana uporaba abatacepta) je prikazan v preglednici 2.
Similarly, the frequencies of serious infection and malignancy among subcutaneous abatacept-treated patients over age 65 were higher than among those under age 65.
Podobno je bila tudi pri subkutani uporabi abatacepta pogostnost hudih okužb in novotvorb večja pri bolnikih, starejših od 65 let, kot pri bolnikih, mlajših od 65 let.
EU/1/07/389/012 12 pre-filled pens (3 packs of 4)
EU/1/07/389/012 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
EU/1/07/389/014 4 pre-filled syringes with needle guard
EU/1/07/389/014 4 napolnjene injekcijske brizge z varovalom za iglo