natgillin/translations-raw huggingface dataset:
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
EU/1/07/389/007 1 napunjene štrcaljke sa štitnikom za iglu EU/1/07/389/008 4 napunjene štrcaljke sa štitnikom za iglu EU/1/07/389/010 3 napunjene štrcaljke sa štitnikom za iglu
Concomitant medication, such as methotrexate, corticosteroids, and NSAIDs, did not influence abatacept apparent clearance.
Istodobno primijenjeni lijekovi, kao što su metotreksat, kortikosteroidi i NSAIL-i, nisu utjecali na prividni klirens abatacepta.
Study I patients were randomised to receive abatacept 2 or 10 mg/kg or placebo for 12 months.
I bolesnici su randomizirani da tijekom 12 mjeseci primaju abatacept u dozi od 2 ili 10 mg/kg, odnosno placebo.
- Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
- - Nakon potpunog otapanja praška, bočicu treba odzračiti iglom kako bi se odstranila eventualna pjena.
Sharps containers are special puncture-resistant disposal bins that can be bought at many retail outlets.
To je posebna posuda koja se ne može probušiti i može se kupiti u mnogim trgovinama.
Non-responder in Period A
Nisu odgovorili u Razdoblju
In placebo-controlled clinical trials with abatacept, adverse reactions (ARs) were reported in 49.4% of abatacept-treated patients and 45.8% of placebo-treated patients.
U placebom kontroliranim kliničkim ispitivanjima abatacepta nuspojave su prijavljene u 49,4% bolesnika liječenih abataceptom i 45,8% bolesnika koji su primali placebo.
Don't use the syringe if it is dropped without the needle cover in place.
Nemojte upotrijebiti štrcaljku ako je pala bez poklopca igle.
Boolean Clinical Remission Estimate of Difference (95% CI) vs. MTX
Klinička remisija prema načelima Booleove algebre Procijenjena razlika (95% CI) u odnosu na MTX
C. Check the liquid in the syringe Hold the syringe by its body, with the covered needle pointing down.
Provjerite tekućinu u štrcaljki Držite štrcaljku za tijelo štrcaljke, prekrivenom iglom okrenutom prema dolje.
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.
Propusti li bolesnik injekciju abatacepta, a od planirane primjene nije prošlo više od 3 dana, treba mu/joj savjetovati da odmah primijeni propuštenu dozu te se dalje pridržava originalnog tjednog rasporeda doziranja.
During the 12-week pre-filled pen period of the substudy, there were no deaths or related SAEs.
Tijekom 12-tjednog razdoblja podispitivanja u kojem se lijek primjenjivao napunjenom brizgalicom nije zabilježen nijedan smrtni slučaj niti ozbiljne nuspojave povezane s lijekom.
Complete ALL steps for full-dose delivery:
Da biste primijenili cijelu dozu, prođite kroz SVE navedene korake:
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.
ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 87,5 mg abatacepta u 0,7 ml.
The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 1).
PsA-I i PsA-II te je bio u skladu sa sigurnosnim profilom kod reumatoidnog artritisa (Tablica 1).
Not assessed a day 169 Last Observation Carried Forward (LOCF) for patients treated in Period C b As observed
Nisu ocijenjeni a Za bolesnike liječene u Razdoblju C dalje su se prenosili rezultati zabilježeni 169. dana b Prema opaženome
During Period B, the time to disease flare for the patients randomised to placebo was significantly shorter than for those randomised to abatacept (primary endpoint, p=0.0002; log-rank test).
Tijekom Razdoblja B, vrijeme do razbuktavanja bolesti u bolesnika randomiziranih za placebo bilo je značajno kraće nego u bolesnika randomiziranih za abatacept (primarna mjera ishoda, p = 0,0002; log-rang test).
ORENCIA contains sodium
ORENCIA sadrži natrij
AFTER THE INJECTION
SAMO kad injekciju daje
Similarly, the frequencies of serious infection and malignancy among subcutaneous abatacept-treated patients over age 65 were higher than among those under age 65.
Slično tomu, učestalost ozbiljnih infekcija i zloćudnih bolesti kod supkutane primjene abatacepta bila je veća u bolesnika starijih od 65 godina, nego u onih mlađih od 65 godina.
Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations (see section 4.5).
Lijekovi koji djeluju na imunološki sustav, uključujući abatacept, mogu umanjiti učinkovitost nekih cijepljenja (vidjeti dio 4.5).
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 5).
+ MTX zabilježena je manja progresija strukturnog oštećenja nego u skupini koja je primala samo MTX, što pokazuje srednja vrijednost razlike između liječenja abataceptom + MTX-om i liječenja samo MTX-om (Tablica 5).
Table 7:
Tablica 7:
The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 2).
PsA-I i PsA-II te je bio u skladu sa sigurnosnim profilom kod reumatoidnog artritisa (Tablica 2).
It's normal to see a drop of fluid leaving the needle.
Normalno je da iz igle izađe kapljica tekućine.
Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present.
Nakon potpunog otapanja praška, bočicu treba odzračiti iglom kako bi se odstranila eventualna pjena.
Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations (see sections 4.4 and
Lijekovi koji djeluju na imunološki sustav, uključujući abatacept, mogu umanjiti učinkovitost nekih cijepljenja (vidjeti dijelove 4.4 i 4.6).
Clinical responses were maintained or continued to improve up to one year in studies PsA-I and PsA-II.
Klinički odgovori održali su se ili su se nastavili poboljšavati do godinu dana u ispitivanjima
Preparation of infusion: immediately after reconstitution, dilute the concentrate to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Priprema infuzije: odmah nakon pripreme, razrijedite koncentrat do volumena od 100 ml otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).
Gently clean injection site with an alcohol swab and let your skin dry.
Nježno očistite mjesto injekcije vatom natopljenom alkoholom i pričekajte da se koža osuši.
Steady state of abatacept was achieved by day 85 following the weekly body-weight-tiered subcutaneous abatacept dosing.
Koncentracije abatacepta postigle su stanje dinamičke ravnoteže do 85. dana uz tjednu primjenu supkutanih doza abatacepta određenih na temelju tjelesne težine.
The primary outcome, incidence of AEs, SAEs, and discontinuations due to AEs during 6 months of treatment, was similar between those who were previous and current TNF-inhibitor users at enrollment, as was the frequency of serious infections.
Primarna mjera ishoda: incidencija nuspojava, ozbiljnih nuspojava i prekida liječenja zbog nuspojava tijekom 6 mjeseci, bila je podjednaka u bolesnika koji su TNF-inhibitorima liječeni ranije i onih koji su uzimali TNF-inhibitore neposredno prije uključivanja u ispitivanje.Isto je vrijedilo i za učestalost ozbiljnih infekcija.
Check the pre-filled syringe for damage.
Provjerite je li napunjena štrcaljka oštećena.
Do not use the pre-filled syringe if it is dropped after the needle cover is removed.
Nemojte upotrijebiti napunjenu štrcaljku ako Vam padne nakon što skinete poklopac igle.
† p < 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p < 0.001, abatacept plus MTX vs. MTX plus placebo †† p < 0.05, abatacept plus MTX vs. MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
*** p < 0,001, abatacept naspram placeba. † p < 0,01, abatacept i MTX naspram MTX i placebo ‡ p < 0,001, abatacept i MTX naspram MTX i placebo †† p < 0,05, abatacept i MTX naspram MTX i placebo a Fiksna doza od približno 10 mg/kg (vidjeti dio 4.2).
There have been reports of tuberculosis in patients receiving ORENCIA (see section 4.8).
U bolesnika koji su primali lijek ORENCIA prijavljeni su slučajevi tuberkuloze (vidjeti dio 4.8).
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.
Stopa incidencije zloćudnih bolesti iznosila je 1,3 (0,9; 1,9) na 100 bolesnik-godina u bolesnika liječenih abataceptom te 1,1 (0,6; 1,9) na 100 bolesnik-godina u bolesnika koji su primali placebo.
In study SC-III, abatacept subcutaneous was evaluated in combination with methotrexate (MTX), or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early, rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g., anti-citrullinated protein antibodies [ACPA+], as measured by antiCCP2 assay, and/or RF+, baseline joint erosions).
U ispitivanju SC-III ocjenjivao se abatacept za supkutanu primjenu u kombinaciji s metotreksatom (MTX) ili u monoterapiji u usporedbi s monoterapijom MTX-om s obzirom na indukciju remisije nakon 12 mjeseci liječenja te moguće održavanje remisije bez liječenja nakon potpunog prekida terapije u odraslih bolesnika s izrazito aktivnim ranim oblikom reumatoidnog artritisa (srednja vrijednost indeksa DAS28-CRP: 5,4; srednja vrijednost trajanja simptoma: manje od 6,7 mjeseci) koji prethodno nisu bili liječeni MTX-om i koji su imali loše prognostičke faktore za brzo progredirajuću bolest (npr. antitijela na citrulinirane proteine [engl. anti-citrullinated protein antibodies, ACPA+], koja su se određivala anti-CCP2 testom, i/ili pozitivan nalaz RF-a, erozije zglobova na početku ispitivanja).
Unless they had discontinued due to safety reasons, all patients who completed, or had a flare during Period B or were non-responders in Period A were offered entry into Period C, the open-label extension, which assessed long-term safety and efficacy.
Ako nisu prekinuli liječenje zbog sigurnosnih razloga, svim bolesnicima koji su završili Razdoblje B ili im se tijekom tog razdoblja bolest razbuktala te onima koji nisu odgovorili na liječenje u Razdoblju
 Supplies checklist: alcohol swabs, cotton ball or gauze, adhesive plaster, Sharps container.
 Popis dodatnog pribora: vata natopljena alkoholom, pamučna vata ili gaza, flaster,
Higher ACR 20 responses were observed with abatacept vs placebo regardless of prior TNF-inhibitor treatment in both studies.
U oba su ispitivanja opažene više stope odgovora ACR 20 uz abatacept nego uz placebo neovisno o prethodnom liječenju TNF-inhibitorima.
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).
ORENCIA je dostupna u pakiranjima od 1 bočice i 1 nesilikonske štrcaljke i u višestrukim pakiranjima koja sadrže 2, odnosno 3 bočice i 2, odnosno 3 nesilikonske štrcaljke (2 ili 3 pakiranja po 1).
Wipe the injection site with an alcohol swab and let your skin dry.
Obrišite mjesto injekcije vatom natopljenom alkoholom i pričekajte da se koža osuši.
Concomitant MTX, NSAIDs, corticosteroids, and TNF-inhibitors did not influence abatacept apparent clearance.
Istodobno primijenjeni MTX, NSAIL-i, kortikosteroidi i TNF-inhibitori ne utječu na prividan klirens abatacepta.
125 mg/mL Pre-filled Syringe
125 mg/mL Napunjena štrcaljka
Care of injection site:
Njega mjesta injekcije:
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.
Propusti li bolesnik injekciju lijeka ORENCIA, a od planirane primjene nije prošlo više od 3 dana, treba mu/joj savjetovati da odmah primijeni propuštenu dozu te se dalje pridržava originalnog tjednog rasporeda doziranja.
During the initial double blind 6 months period (short term period), the overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710)for the subcutaneous and intravenous groups, respectively.
Tijekom početnog dvostruko slijepog 6-mjesečnog razdoblja (kratkotrajno razdoblje) ukupna učestalost imunogenosti na abatacept iznosila je 1,1% (8/725) u skupini u kojoj je primijenjen supkutano te 2,3% (16/710) u skupini u kojoj je primijenjen intravenski.
B. Prepare your injection site Wipe your injection site with an alcohol swab in a circular motion.
Pripremite mjesto injekcije Kružnim pokretom obrišite mjesto injekcije vatom natopljenom alkoholom.
The other ingredients are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections (see section 2 "ORENCIA contains sodium").
Drugi sastojci su: saharoza, poloksamer 188, natrijev dihidrogenfosfat hidrat, bezvodni natrijev hidrogenfosfat i voda za injekcije (vidjeti dio 2. "ORENCIA sadrži natrij").
† p < 0.01, abatacept plus MTX vs. MTX plus placebo ‡ p < 0.001, abatacept plus MTX vs. MTX plus placebo †† p < 0.05, abatacept plus MTX vs. MTX plus placebo § 95% CI: −4.2, 4.8 (based on prespecified margin for non-inferiority of −7.5%) §§ITT data is presented in table a Fixed dose approximating 10 mg/kg (see section 4.2).
*** p < 0,001, abatacept naspram placeba. † p < 0,01, abatacept i MTX naspram MTX i placebo ‡ p < 0,001, abatacept i MTX naspram MTX i placebo †† p < 0,05, abatacept i MTX naspram MTX i placebo § 95% CI: −4,2; 4,8 (na temelju prethodno određene granice za neinferiornost od −7,5%) §§U tablici su prikazani podaci za populaciju svih uključenih bolesnika (engl. intend-to-treat, ITT) a Fiksna doza od približno 10 mg/kg (vidjeti dio 4.2).
During the extension period of the pJIA studies (20 months in the pJIA SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Tijekom razdoblja nastavka ispitivanja primjene kod pJIA-a (20 mjeseci u ispitivanju pJIA SC i 5 godina u ispitivanju pJIA IV) sigurnosni profil u bolesnika s pJIA-om u dobi od 6 do 17 godina starosti bio je usporediv s onim u odraslih bolesnika.
It may also be helpful to write down any questions or concerns about the injection so you can ask your doctor, nurse or pharmacist.
Ako imate nekih pitanja ili Vas nešto brine u vezi s injekcijom, pomoći će ako to zapišete, tako da možete pitati svog liječnika, medicinsku sestru ili ljekarnika.
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.
U randomiziranom i dvostruko slijepom ispitivanju ocjenjivali su se abatacept za supkutanu primjenu u kombinaciji s metotreksatom (abatacept + MTX), monoterapija abataceptom za supkutanu primjenu i monoterapija metotreksatom (skupina liječena samo MTX-om) s obzirom na indukciju remisije nakon 12 mjeseci liječenja te održavanje remisije bez liječenja nakon potpunog prekida terapije u odraslih bolesnika s izrazito aktivnim ranim oblikom reumatoidnog artritisa koji prethodno nisu bili liječeni MTX-om i koji su imali loše prognostičke faktore.
0.4 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (white plunger).
0,4 ml u napunjenoj štrcalji (staklo tipa I) sa s automatskim sigurnosnim štitnikom za iglu i proširenim rubnikom (bijeli klip).
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).
Ispitivanje otvorene intravenske primjene abatacepta uz osnovnu terapiju nebiološkim DMARD-ima provedeno je u bolesnika s aktivnim reumatoidnim artritisom koji nisu dovoljno dobro odgovorili na prethodnu (faza ispiranja u trajanju od najmanje 2 mjeseca, n=449) ili trenutnu (bez faze ispiranja, n=597) terapiju TNF-inhibitorima (ispitivanje VII).
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.
U ispitivanju SC-I cilj je bio dokazati neinferiornost u pogledu djelotvornosti te usporedivu sigurnost abatacepta primijenjenog supkutano u odnosu na intravensku primjenu u ispitanika s umjerenim do teškim oblikom aktivnog reumatoidnog artritisa koji nisu dovoljno dobro odgovorili na MTX.
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).
Bolesnici su imali aktivnu bolest te su na početku ispitivanja imali prosječno 16 aktivnih zglobova, 16 zglobova u kojima je pokretljivost bila izgubljena, povišene razine C-reaktivnog proteina (CRP) (prosječna vrijednost 3,2 mg/dl) i povišenu brzinu sedimentacije eritrocita (prosječna vrijednost 32 mm/h).
Do not use if the expiry date has passed.
NEMOJTE je upotrijebiti ako je istekao rok valjanosti.
ORENCIA (abatacept)
Supkutana (potkožna) primjena
Similar inhibition was observed in both treatment groups up to 24 months (mTSS (mean ± standard deviation [SD] = 0.89 ± 4.13 vs 1.13 ±8.66), erosion score (0.41 ± 2.57 vs 0.41 ±5.04), and JSN score (0.48 ±2.18 vs 0.72 ±3.81)) for the abatacept (n=257) and adalimumab (n=260) groups, respectively.
U obje je skupine, onoj koja je primala abatacept (n=257) i onoj koja je primala adalimumab (n=260), primijećena slična inhibicija tijekom 24 mjeseca (mTSS (srednja vrijednost ± standardno odstupanje = 0,89 ± 4,13 naspram 1,13 ± 8,66), ocjena erozije (0,41 ± 2,57 naspram 0,41 ±5,04) i ocjena JSN-a (0,48 ±2,18 naspram 0,72 ±3,81)).
0.7 mL Fill line
0,7 ml Linija punjenja
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1, 3 AND 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJA OD 1, 3, I 4 NAPUNJENE ŠTRCALJKE SA ŠTITNIKOM ZA IGLU
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.
U ispitivanju SC-III su tijekom dvostruko slijepog 12-mjesečnog razdoblja primijećene slične stope imunogenosti u bolesnika koji su primali abatacept + MTX i onih koji su se liječili monoterapijom abataceptom (2,9% [3/103] naspram 5,0% [5/101]).
During the extension period of the pJIA studies (20 months in the pJIA ongoing SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Tijekom razdoblja nastavka ispitivanja primjene kod pJIA (20 mjeseci u ispitivanju pJIA SC, koje je još u tijeku, i 5 godina u ispitivanju pJIA IV) sigurnosni profil u bolesnika s pJIA-om u dobi od 6 do 17 godina bio je usporediv s onim u odraslih bolesnika.
MRI Synovitis Score
MRI rezultat za sinovitis
Abdominal pain, diarrhoea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting Uncommon Gastritis
Poremećaji probavnog sustava često bol u abdomenu, proljev, mučnina, dispepsija, ulceracije u ustima, aftozni stomatitis, povraćanje manje često gastritis
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.
PsA-I, među bolesnicima koji prethodno nisu bili liječeni TNF-inhibitorima odgovor ACR 20 postiglo je 55,6% bolesnika liječenih abataceptom u intravenskoj dozi od 10 mg/kg i 20,0% onih koji su primali placebo, dok je među bolesnicima prethodno liječenima TNF-inhibitorima isto zabilježeno u 30,8% odnosno 16,7% bolesnika.
One hundred and two (67%) of the subjects had received at least 1,080 days (~ 36 months) of abatacept therapy in Period C. All patients had at least 4 months of prior, open-label abatacept treatment in Period A.
U Razdoblju C su 102 (67%) ispitanika imala najmanje 1080 dana (~ 36 mjeseci) liječenja abataceptom.
Therefore, ORENCIA solution for injection in pre-filled syringe is not recommended for use in this patient population.
Stoga se ne preporučuje primjena ORENCIA otopine za injekciju u napunjenoj štrcaljki u ovoj populaciji bolesnika.
Abatacepta +DMARDsb n = 256
Abatacepta +DMARD-i b n = 256
Methotrexate, NSAIDs, corticosteroids, and TNF-inhibitors were not found to influence abatacept clearance.
Utvrđeno je da metotreksat, NSAIL-i, kortikosteroidi i TNF-inhibitori ne utječu na klirens abatacepta.
In study VI, the efficacy and safety of abatacept were assessed in methotrexate-naive, Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide 2 (Anti-CCP2)-positive patients with early, erosive rheumatoid arthritis (≤ 2 years disease duration) who were randomised to receive abatacept plus methotrexate or methotrexate plus placebo.
U ispitivanju VI ispitivale su se djelotvornost i sigurnost abatacepta u bolesnika s ranim, erozivnim reumatoidnim artritisom (trajanje bolesti ≤ 2 godine) koji prethodno nisu primali metotreksat, a imali su pozitivan nalaz reumatoidnog faktora (RF) i/ili antitijela na ciklički citrulinirani peptid 2 (anti-CCP2).
The Type 1 glass syringe has a coated stopper and fixed stainless steel needle covered with a rigid needle shield.
Staklena štrcaljka (staklo tipa 1) ima obložen čep i pričvršćenu iglu od nehrđajućeg čelika prekrivenu tvrdim štitnikom za iglu.
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.
Bolesnici kojima se početni broj bolnih i otečenih zglobova nije poboljšao za najmanje 20% do 16. tjedna prešli su na otvoreno liječenje abataceptom u supkutanoj dozi od 125 mg tjedno.
- After reconstitution the solution should be clear and colourless to pale yellow.
- Rekonstituirana otopina mora biti bistra i bezbojna do blijedožuta.
Proceed to Step 5
Prijeđite na 5. korak
Patients should be screened for latent tuberculosis prior to initiating ORENCIA.
Prije uvođenja lijeka ORENCIA bolesnike treba testirati na latentnu tuberkulozu.
Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
Jedna napunjena štrcaljka sadrži 50 mg abatacepta u 0,4 ml.
Each vial contains 250 mg of abatacept.
Jedna bočica sadrži 250 mg abatacepta.
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]).
U ispitivanju PsA-II, udio bolesnika koji su postigli odgovor PASI 50 iznosio je 26,7% uz abatacept i 19,6% uz placebo (7,3 [-2,2; 16,7], procjena razlike [95% CI]), dok je udio bolesnika koji su postigli odgovor PASI 75 iznosio 16,4% uz abatacept odnosno 10,1% uz placebo (6,4 [-1,3; 14,1], procjena razlike [95% CI]).