natgillin/translations-raw huggingface dataset:
Very common (may affect more than 1 in 10 people): infections of the upper airway (including infections of the nose, throat and sinuses).
Vrlo često (mogu se javiti u više od 1 na 10 osoba): infekcije gornjih dišnih putova (uključujući infekcije nosa, grla i sinusa).
It is unknown whether abatacept is excreted in human milk.
Nije poznato izlučuje li se abatacept u majčino mlijeko u ljudi.
Write down the date, time, and specific part of your body where you injected yourself.
Zapišite datum, vrijeme i područje tijela u koje ste primijenili injekciju.
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.
Nakon 12 mjeseci je incidencija infekcija kao nuspojave u skupini liječenoj abataceptom iznosila 59,6% (93), a u skupini liječenoj infliksimabom 68,5% (113), dok je incidencija infekcija kao ozbiljne nuspojave u skupini liječenoj abataceptom bila 1,9% (3), a u skupini liječenoj infliksimabom 8,5% (14).
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.
Prosječne vrijednosti (raspon) Cmin i Cmax u stanju dinamičke ravnoteže zabilježene nakon 85 dana liječenja bile su 32,5 µg/ml (6,6 do 113,8 µg/ml), odnosno 48,1 µg/ml (9,8 to 132,4 µg/ml).
Do not remove the needle cover while allowing the pre-filled syringe to reach room temperature.
Nemojte skidati poklopac igle dok čekate da se napunjena štrcaljka ugrije na sobnu temperaturu.
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].
Prilagođena srednja geometrijska vrijednost najniže koncentracije abatacepta u stanju dinamičke ravnoteže (Cminss) iznosila je 25,3 µg/ml za supkutanu formulaciju u napunjenoj brizgalici te 27,8 µg/ml za supkutanu formulaciju u napunjenoj štrcaljki, uz omjer od 0,91 [90% CI: 0,83; 1,00].
After 24 months, adverse reactions were reported in 41.5% (132/318) and 50% (164/328) of abatacept and adalimumab-treated patients.
Nakon 24 mjeseca nuspojave su prijavljene u 41,5% (132/318) bolesnika liječenih abataceptom i 50% (164/328) bolesnika liječenih adalimumabom.
Abatacept has been studied in patients with active psoriatic arthritis in two placebo-controlled clinical trials (341 patients with abatacept, 253 patients with placebo) (see Section 5.1).
Abatacept se ispitivao u bolesnika s aktivnim psorijatičnim artritisom u dvama placebom kontroliranim kliničkim ispitivanjima (341 bolesnik primao je abatacept, a 253 placebo) (vidjeti dio 5.1).
Remove the syringe and needle after 10 mL of water for injections have been injected into the vial.
Izvadite štrcaljku i iglu nakon što ste 10 ml vode za injekcije ubrizgali u bočicu.
ORENCIA should be administered weekly at a dose of 125 mg by subcutaneous (SC) injection without the need for an intravenous (IV) loading dose.
ORENCIA se primjenjuje supkutanom (s.c.) injekcijom u dozi od 125 mg jedanput na tjedan, bez potrebe za udarnom intravenskom (i.v.) dozom.
Twenty-two of 48 evaluable patients showed significant neutralizing activity.
Značajno neutralizirajuća aktivnost utvrđena je u 22 od 48 bolesnika dostupnih za evaluaciju.
During the 24-month cumulative period of the pJIA SC study (4-month short term period plus 20-month extension period), a higher frequency of infections was reported in the 2 to 5 year age cohort (87.0%) compared to that reported in the 6 to 17 year age cohort (68.2%).
Tijekom 24-mjesečnog kumulativnog razdoblja ispitivanja pJIA SC studije (4-mjesečno kratkoročno razdoblje plus 20-mjesečno razdoblje nastavka), veća učestalost infekcija prijavljena je u kohorti od 2 do 5 godina starosti (87,0%) u usporedbi s onim prijavljenim u kohorti u dobi od 6 do 17 godina starosti (68,2%).
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.
ORENCIA je, sama ili u kombinaciji s metotreksatom (MTX), indicirana za liječenje aktivnog psorijatičnog artritisa (PsA) u odraslih bolesnika u kojih odgovor na prethodnu terapiju DMARD-ima, uključujući MTX, nije bio dovoljno dobar i kojima nije potrebna dodatna sistemska terapija za psorijatične kožne lezije.
In addition, inflammation of the thyroid and pancreas was frequently seen in both juvenile and adult rats exposed to abatacept.
Osim toga, i u mladih i u odraslih štakora izloženih abataceptu često su zabilježene upala štitnjače i gušterače.
Release skin pinch.
Otpustite nabor kože.
The proportion of patients who discontinued treatment due to ARs was 3.0% for abatacept-treated patients and 2.0% for placebo-treated patients.
Udio bolesnika koji su prekinuli liječenje zbog nuspojava iznosio je 3,0% među bolesnicima liječenima abataceptom te 2,0% među bolesnicima koji su primali placebo.
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.
Stopa incidencije (95% CI) ozbiljnih infekcija u dvostruko slijepim ispitivanjima iznosila je 3,0 (2,3; 3,8) na 100 bolesnik-godina u bolesnika liječenih abataceptom te 2,3 (1,5; 3,3) na 100 bolesnik-godina u bolesnika koji su primali placebo.
− If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Ako dobijete simptome koji upućuju na infekcije, kao što su vrućica, uporan kašalj, gubitak tjelesne težine ili bezvoljnost, odmah potražite liječničku pomoć.
Uncommon Palpitations, tachycardia, bradycardia
Srčani poremećaji manje često palpitacije, tahikardija, bradikardija
12% 14%*** 2% NAd
12% 14%*** 2% NDd
To minimise foam formation in solutions of ORENCIA the vial should be rotated with gentle swirling until the contents are completely dissolved.
Kako biste smanjili pjenjenje otopine lijeka ORENCIA, bočicu treba nježno okretati dok se sadržaj potpuno ne otopi.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe
4. FARMACEUTSKI OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki
Needle Cover (ORANGE Cap)
Pokrov igle (NARANČASTI zatvarač)
- Do not store any unused portion of the infusion solution for reuse.
- Neiskorišteni dio otopine za infuziju ne smije se čuvati za ponovnu primjenu.
In PsA-I, patients were randomised to receive intravenous placebo or abatacept 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), or two doses of 30 mg/kg followed by 10 mg/kg (30/10 mg/kg), on day 1, 15, 29, and then every 28 days thereafter.
PsA-I, bolesnici su bili randomizirani za intravensko primanje placeba ili abatacepta u dozi od 3 mg/kg (3/3 mg/kg), abatacepta u dozi od 10 mg/kg (10/10 mg/kg) ili dviju doza abatacepta od 30 mg/kg, a zatim doze od 10 mg/kg (30/10 mg/kg) 1., 15. i 29. dana te svakih 28 dana nakon toga.
No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/kg at monthly intervals in rheumatoid arthritis patients.
U bolesnika s reumatoidnim artritisom nije došlo do sustavne akumulacije abatacepta nakon kontinuiranog ponovljenog liječenja dozom od 10 mg/kg u mjesečnim intervalima.
Immediately after reconstitution, the concentrate must be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Odmah nakon rekonstitucije, koncentrat se mora dodatno razrijediti do volumena od 100 ml otopinom natrijevog klorida za injekciju od 9 mg/ml (0,9%).
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.
U bolesnika s pJIA-om abatacept se također ispitivao u supkutanoj formulaciji u djece i adolescenata s umjerenim do teškim oblikom aktivnog pJIA-a u dobi od 2 do 17 godina koji na najmanje jedan DMARD nisu dovoljno dobro odgovorili ili ga nisu podnosili, a koji je mogao biti i biološki lijek.
Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial.
Polako dodajte pripremljenu otopinu lijeka ORENCIA iz svake bočice u infuzijsku vrećicu ili bocu, koristeći istu nesilikonsku štrcaljku za jednokratnu uporabu priloženu uz svaku bočicu.
87.5 mg/0.7 mL light blue plunger
87,5 mg/0,7 mL svjetloplavi klip
Patients were randomised to receive placebo or abatacept 3 mg/kg, 10 mg/kg, or two doses of 30 mg/kg followed by 10 mg/kg, without escape for 24 weeks, followed by open label abatacept 10 mg/kg monthly intravenous every month.
Bolesnici su bili randomizirani za primanje placeba, abatacepta u dozi od 3 mg/kg, abatacepta u dozi od 10 mg/kg ili dviju doza abatacepta od 30 mg/kg, praćenih s 10 mg/kg tijekom 24 tjedna, bez mogućnosti prijevremenog prelaska s placeba na abatacept (engl. escape), nakon čega je uslijedila otvorena primjena abatacepta u dozi od 10 mg/kg intravenski svaki mjesec.
Typical estimates for distribution volume and elimination half-life were 0.12 L/kg and 11.4 days, respectively, for a child weighing 40 kg. As a result of the higher body-weight normalised clearance and volume of distribution in pJIA patients, the predicted and observed systemic exposures of abatacept were lower than that observed in adults, such that the observed mean (range) peak and trough concentrations were 204 (66 to 595) mcg/mL and 10.6 (0.15 to 44.2) mcg/mL, respectively, in patients weighing less than 40 kg, and 229 (58 to 700) mcg/mL and 13.1 (0.34 to 44.6) mcg/mL, respectively, in patients weighing 40 kg or greater.
Kao rezultat većeg klirensa normaliziranog za tjelesnu težinu i većeg volumena distribucije u bolesnika s pJIA-om, predviđene i opažene razine sistemske izloženosti abataceptu bile su niže nego u odraslih, tako da su opažene prosječne (raspon) najviše i najniže koncentracije bile 204 (66 do 595) µg/ml i 10,6 (0,15 do 44,2) µg/ml u bolesnika tjelesne težine manje od 40 kg, odnosno 229 (58 do 700) µg/ml i 13,1 (0,34 do 44,6) µg/ml u bolesnika tjelesne težine 40 kg ili više.
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.
ORENCIA se može primati s drugim lijekovima koji se uobičajeno koriste za liječenje reumatoidnog artritisa, kao što su steroidi ili lijekovi protiv bolova, uključujući nesteroidne protuupalne lijekove poput ibuprofena ili diklofenaka.
- To minimise foam formation in solutions of ORENCIA, the vial should be rotated with gentle swirling until the contents are completely dissolved.
- - Kako biste smanjili stvaranje pjene u otopini lijeka ORENCIA, bočicu treba nježno okretati dok se sadržaj potpuno ne otopi.
If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly 125 mg subcutaneous injections.
Ako na početku liječenja primite jednu dozu lijeka u venu, prvu supkutanu (potkožnu) injekciju lijeka ORENCIA trebate primiti unutar jednoga dana nakon infuzije u venu, nakon čega će se liječenje nastaviti tjednim supkutanim (potkožnim) injekcijama u dozi od 125 mg.
In the cumulative period in clinical trials in 7,044 patients treated with abatacept during 20,510 patient-years, the incidence rate of serious infections was 2.4 per 100 patient-years, and the annualised incidence rate remained stable.
U kumulativnom razdoblju u kliničkim ispitivanjima, u 7044 bolesnika liječena abataceptom tijekom 20 510 bolesnik-godina stopa incidencije ozbiljnih infekcija iznosila je 2,4 na 100 bolesnik-godina te je ostala stabilna na godišnjoj razini.
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.
ORENCIA se može primjenjivati s drugim lijekovima koji se uobičajeno koriste za liječenje reumatoidnog artritisa, kao što su steroidi ili lijekovi protiv bolova, uključujući nesteroidne protuupalne lijekove poput ibuprofena ili diklofenaka.
Of the 190 patients enrolled, 170 completed Period A, 65% (123/190) achieved an ACR Pedi 30 response, and 122 were randomised to Period B. Responses were similar in all subtypes of pJIA studied and for patients with or without methotrexate use.
Od 190 bolesnika uključenih u ispitivanje, 170 ih je završilo Razdoblje A, 65% (123/190) njih je postiglo odgovor Ped ACR30, a 122 bolesnika randomizirana su u Razdoblje B.
50 mg/0.4 mL Pre-filled Syringe
50 mg/0,4 mL Napunjena štrcaljka
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.
Bolesnici su imali aktivnu bolest te su na početku ispitivanja imali prosječno 11,8 aktivnih zglobova, 10,3 zgloba u kojima je pokretljivost bila izgubljena i povišene razine C-reaktivnog proteina (CRP) (prosječna vrijednost: 1,24 mg/dl).
Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (2,653 patients with abatacept, 1,485 with placebo).
Abatacept je ispitivan u bolesnika s aktivnim reumatoidnim artritisom u placebom kontroliranim kliničkim ispitivanjima (2653 bolesnika primala su abatacept, a 1485 placebo).
Table 9:
Tablica 9:
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.
Vidjeti sažetak opisa svojstava lijeka za ORENCIA prašak za koncentrat za otopinu za infuziju od 250 mg i ORENCIA otopinu za injekciju u napunjenoj štrcaljki od 125 mg, 87,5 mg i 50 mg.
D. Gather your additional supplies and keep them within easy reach.
Prikupite dodatni pribor i držite ga nadohvat ruke.
DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.
NEMOJTE skidati pokrov igle s brizgalice dok čekate da se ugrije na sobnu temperaturu.
Vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium).
Bočica (15 ml, staklo tipa 1) s čepom (halobutilna guma) i zaštitnom "flip-off" kapicom i prstenom (aluminij)
In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
U ispitivanju VI, u koje su uključeni samo odrasli bolesnici, nakon godinu dana liječenja je remisiju prema indeksu DAS28--CRP (rezultat < 2,6) postigao značajno veći udio bolesnika u skupini abatacept i metotreksat (41%) u usporedbi s bolesnicima u skupini metotreksat i placebo (23%).
- Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
- - Uvedite iglu u bočicu kroz sredinu gumenog čepa i usmjerite mlaz vode za injekcije na staklenu stijenku bočice.
Gather supplies for your injection on a clean, flat surface (only the ClickJect Pre-filled Pen is included in the package): Alcohol swab
Položite pribor za injekciju na čistu i ravnu površinu (u pakiranje je uključena samo napunjena brizgalica ClickJect): vatu natopljena alkoholom flaster pamučnu vatu ili gazu napunjenu brizgalicu ClickJect spremnik za odlaganje oštrih predmeta
• Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
• Prilikom svakog posjeta liječniku obavezno ponesite popis svih drugih lijekova koje uzimate.
In SC-I, the ACR 20 response rates at day 169 for subcutaneous and intravenous abatacept were respectively 78.3% (472/603 SC) and 76.0% (456/600 IV) in patients < 65 years, versus 61.1% (55/90 SC) and 74.4% (58/78 IV) for patients ≥ 65 years.
U ispitivanju SC-I udio odgovora ACR20 169. dana iznosio je 78,3% (472/603) kod supkutane primjene i 76,0% (456/600) kod intravenske primjene u bolesnika mlađih od 65 godina, u odnosu na 61,1% (55/909) kod supkutane primjene te 74,4% (58/78) kod intravenske primjene u bolesnika u dobi od ≥ 65 godina.
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).
U placebom kontroliranim kliničkim ispitivanjima je u bolesnika liječenih kombinacijom TNF-inhibitora i abatacepta zabilježen porast broja ukupnih infekcija i ozbiljnih infekcija u usporedbi s bolesnicima koji su primali TNF-inhibitore i placebo (vidjeti dio 4.5).
B. Position the syringe and inject ORENCIA Hold the syringe by its body in one hand between your thumb and index finger (Figure 5).
Držite štrcaljku za tijelo štrcaljke između palca i kažiprsta jedne ruke (Slika 5).
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.
U pretkliničkim istraživanjima embrio-fetalnog razvoja nisu zabilježene nuspojave pri dozama koje su, na temelju AUC-a, bile do 29 puta veće od doze za ljude od 10 mg/kg.
The abatacept + MTX group had less progression in structural damage compared with MTX group as reflected by mean treatment difference of the abatacept + MTX group versus MTX group (Table 6).
+ 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 6).
Let your Pre-filled syringe warm up.
Pričekajte da se napunjena štrcaljka ugrije.
• See the ORENCIA package leaflet for more information.
• Za dodatne informacije pročitajte uputu o lijeku za lijek ORENCIA.
With your other hand, gently pinch the cleaned skin.
Drugom rukom nježno uhvatite nabor očišćene kože.
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.
ORENCIA se obično primjenjuje u kombinaciji s metotreksatom, ali može se koristiti i sama ako bolesnik ne podnosi metotreksat ili ako liječenje metotreksatom nije prikladno.
Injection Reactions in adult patients treated with subcutaneous abatacept
Reakcije na injekcije u odraslih bolesnika liječenih abataceptom primijenjenim supkutano
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.
Nakon što se napunjena brizgalica izvadi iz hladnjaka, treba pričekati 30 minuta da se napunjena brizgalica zagrije na sobnu temperaturu prije injiciranja lijeka ORENCIA.
125 mg/mL orange plunger
125 mg/mL narančasti klip
One patient was diagnosed with multiple sclerosis while in the extension period of the pJIA IV study.
U jednog je bolesnika tijekom razdoblja nastavka ispitivanja pJIA IV dijagnosticirana multipla skleroza.
Placebo +DMARDsb n = 133
Placebo +DMARD-i b n = 133
Choose your injection site in either the abdomen or front of the thigh.
Odaberite mjesto injekcije na trbuhu ili prednjem dijelu bedara.
Do not use this medicine if the liquid is cloudy or discoloured, or has large particles.
Ovaj lijek se ne smije upotrijebiti ako je tekućina mutna ili je promijenila boju, ili sadrži velike čestice.
Abatacept has been studied in patients with pJIA in 2 clinical trials (ongoing pJIA SC study and pJIA IV study).
Abatacept se ispitivao u bolesnika s pJIA-om u dvama kliničkim ispitivanjima (ispitivanje pJIA SC, koje je u tijeku, i ispitivanje pJIA IV).
Population pharmacokinetic analyses revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
Analize populacijske farmakokinetike otkrile su trend povećanja klirensa abatacepta s povećanjem tjelesne težine.
A randomised, single(investigator)-blinded, non-inferiority study was conducted to assess the safety and efficacy of weekly subcutaneous (SC) abatacept without an abatacept intravenous (IV) loading dose versus every-other-weekly subcutaneous adalimumab, both with background MTX, in patients with an inadequate response to methotrexate (study SC-II).
Randomizirano, jednostruko (za ispitivača) slijepo ispitivanje neinferiornosti provedeno je s ciljem ocjenjivanja sigurnosti i djelotvornosti abatacepta primijenjenog supkutano (s.c.) jedanput na tjedan bez intravenske (i.v.) udarne doze abatacepta naspram adalimumaba primijenjenog supkutano jedanput svaka dva tjedna u bolesnika koji nisu dovoljno dobro odgovorili na metotreksat; oba lijeka primjenjivala su se uz osnovnu terapiju MTX-om (ispitivanje SC-II).
Among the patients who entered the open-label 12 month period, 59% (125/213) of patients receiving continuous abatacept plus methotrexate treatment and 48% (92/192) of patients who initially received methotrexate and switched to combination with abatacept had no progression.
Među bolesnicima koji su ušli u otvoreno 12-mjesečno razdoblje ispitivanja, progresija nije nastupila u 59% (125/213) onih koji su kontinuirano liječeni abataceptom i metotreksatom te u 48% (92/192) bolesnika koji su najprije primali metotreksat i placebo pa su potom prebačeni na kombinaciju s abataceptom.
ORENCIA solution for injection in pre-filled pen has not been studied in children and adolescents under the age of 18 years.
ORENCIA otopina za injekciju u napunjenoj brizgalici nije ispitivana u djece i adolescenata mlađih od 18 godina.
DAS28-CRP Remissione
Remisija prema indeksu DAS28-CR
Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use.
Upotrijebljenu napunjenu brizgalicu ClickJect odložite u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
In addition, study V investigated the safety and efficacy of abatacept or infliximab relative to placebo.
V ispitivale su se sigurnost i djelotvornost abatacepta ili infliksimaba u odnosu na placebo.
Common (may affect up to 1 in 10 people): upper airway infection (including infections of nose, sinus and throat) fever
Često (mogu se javiti u do 1 na 10 osoba): infekcija gornjih dišnih putova (uključujući infekcije nosa, sinusa i grla) vrućica
PREPARE YOUR CLICKJECT PEN
Upoznajte svoju napunjenu brizgalicu ClickJect
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.
Od 133 (70%) bolesnika koji prethodno nisu bili na terapiji TNF-inhibitorima, 101 (76%) je postigao barem odgovor Ped ACR30.
ORENCIA solution for injection is injected under the skin (subcutaneous use).
ORENCIA otopina za injekciju injicira se supkutano (potkožno).
Dispose the used pre-filled syringe into sharps disposal container right away after use.
Upotrijebljenu štrcaljku odložite u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
Immunogenicity in patients with pJIA treated with subcutaneous abatacept
Imunogenost u bolesnika s pJIA-om liječenih supkutanom formulacijom abatacepta
Before you are given ORENCIA, your doctor may examine you for hepatitis.
Prije nego što primite lijek ORENCIA, liječnik će Vas možda testirati na hepatitis.
This medicinal product contains 0.014 mmol sodium (0.322 mg) per pre-filled pen, that is to say essentially ‘sodium- free'.
Ovaj lijek sadrži 0,014 (0,322 mg) mmol natrija po napunjenoj brizgalici, tj.zanemarive količine natrija.