natgillin/translations-raw huggingface dataset:
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).
Ispitivanje otvorene 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).
Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
Jedna napunjena štrcaljka sadrži 87,5 mg abatacepta u 0,7 ml.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Periodička izvješća o neškodljivosti (PSUR-evi) Zahtjevi za podnošenje PSUR-evaza ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107c stavkom 7.
Abatacept was also evaluated in an open-label study in rheumatoid arthritis patients administered the seasonal influenza trivalent virus vaccine.
Abatacept je ocijenjen i u otvorenom ispitivanju u bolesnika s reumatoidnim artritisom koji su primili trovalentno virusno cjepivo protiv sezonske gripe.
87.5 mg/0.7 mL Pre-filled Syringe
87,5 mg/0,7 mL Napunjena štrcaljka
ORENCIA 125 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 125 mg of abatacept in one mL.
ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 125 mg abatacepta u jednom ml.
In placebo-controlled clinical trials, malignancies were reported in 1.2% (31/2,653) of abatacepttreated patients and in 0.9% (14/1,485) of placebo-treated patients.
U placebom kontroliranim kliničkim ispitivanjima zloćudne su bolesti prijavljene u 1,2% (31/2653) bolesnika liječenih abataceptom te u 0,9% (14/1485) bolesnika koji su primali placebo.
Package leaflet: Information for the patient ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe abatacept
Uputa o lijeku: Informacije za bolesnika ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki abatacept
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 intravenous every 28 days.
U ispitivanju PsA-I, 170 bolesnika primalo je intravenski placebo ili abatacept 1., 15. i 29. dana te svakih 28 dana nakon toga na dvostruko slijep način tijekom 24 tjedna, nakon čega je uslijedila otvorena primjena abatacepta u dozi od 10 mg/kg intravenski svakih 28 dana.
ORENCIA SC should be administered weekly at a dose of 125 mg by subcutaneous injection regardless of weight (see section 5.1).
ORENCIA za supkutanu primjenu primjenjuje se supkutanom injekcijom u dozi od 125 mg jedanput na tjedan, neovisno o tjelesnoj težini (vidjeti dio 5.1).
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.
U ispitivanju VI je tijekom 29 dana opaženo statistički značajno poboljšanje odgovora ACR20 u bolesnika koji su primali abatacept i metotreksat u odnosu na bolesnike koji su primali placebo, i to je poboljšanje ostalo značajno tijekom cjelokupnog trajanja ispitivanja.
Do not use prolonged or vigorous agitation.
Nemojte je dugotrajno i žustro mućkati.
One mL pre-filled syringe (type 1 glass) with flange extenders or one mL pre-filled syringe with an automatic needle safety guard and flange extenders (orange plunger).
Napunjena štrcaljka volumena 1 ml (staklo tipa 1) s proširenim rubnikom ili napunjena štrcaljka volumena 1 ml s automatskim sigurnosnim štitnikom za iglu i proširenim rubnikom (narančasti klip).
A randomised, double-blind study was conducted to assess the safety and efficacy of abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (study V).
Provedeno je randomizirano, dvostruko slijepo ispitivanje sigurnosti i djelotvornosti abatacepta ili infliksimaba naspram placeba u bolesnika koji nisu dovoljno dobro odgovorili na metotreksat (ispitivanje V).
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.
Učestalost lokalnih reakcija na mjestu injekcije iznosila je 3,8% (12/318) u skupini liječenoj abataceptom za supkutanu primjenu i 9,1% (30/328) u skupini liječenoj adalimumabom za supkutanu primjenu nakon 12 mjeseci (p=0,006), a 4,1% (13/318) odnosno 10,4% (34/328) nakon 24 mjeseca.
Study SC-II investigated the relative efficacy and safety of abatacept and adalimumab, both given subcutaneously without an intravenous loading dose and with background MTX, in patients with moderate to severely active RA and an inadequate response to previous MTX therapy.
U ispitivanju SC-II ispitivale su se relativna djelotvornost i sigurnost abatacepta i adalimumaba u bolesnika s umjerenim do teškim oblikom aktivnog RA koji nisu dovoljno dobro odgovorili na prethodnu terapiju MTX-om; oba su se lijeka primjenjivala supkutano bez intravenske udarne doze, uz osnovnu terapiju MTX-om.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 87.5 mg injection abatacept
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 87,5 mg injekcija abatacept s.c.
Patients in the sub-study (n=117) of the open-label extension of study SC-I received 125 mg of subcutaneous abatacept administered weekly via the pre-filled syringe for at least 4 months, and were then switched to receive 125 mg SC abatacept administered weekly via the pre-filled pen for 12 weeks.
Bolesnici koji su sudjelovali u podispitivanju (n=117) otvorenog produžetka ispitivanja SC-I primali su abatacept za supkutanu primjenu u dozi od 125 mg jedanput na tjedan napunjenom štrcaljkom tijekom najmanje 4 mjeseca.
Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in studies II, III, IV, V, and VI and the modified HAQ-DI in study I. The results from studies II, III, and VI are shown in Table 7.
Poboljšanje fizičke funkcije se u ispitivanjima II, III, IV, V i VI mjerilo indeksom nesposobnosti Upitnika za procjenu zdravlja (engl.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or pJIA.
Liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju reumatoidnog artritisa odnosno poliartikularnog juvenilnog idiopatskog artritisa.
Age and gender (when corrected for body weight) did not affect clearance.
Dob i spol (korigirani za tjelesnu težinu) nisu utjecali na klirens.
ORENCIA Patient Alert Card
ORENCIA kartica s upozorenjima za bolesnika
The rate of seropositivity while patients were receiving abatacept therapy was 0.5% (1/189) during Period A; 13.0% (7/54) during Period B; and 12.8% (19/148) during Period C. For patients in Period B who were randomised to placebo (therefore withdrawn from therapy for up to 6 months) the rate of seropositivity was 40.7% (22/54).
Udio seropozitivnosti za vrijeme liječenja abataceptom iznosio je 0,5% (1/189) tijekom Razdoblja A, 13,0% (7/54) tijekom Razdoblja B te 12,8% (19/148) tijekom Razdoblja C.
Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 4.
Abatacept i metotreksat su nakon 12 mjeseci liječenja smanjili brzinu napredovanja strukturnog oštećenja u usporedbi s primjenom placeba i metotreksata, kako je prikazano u Tablici
Packs of 4 pre-filled syringes with needle guard.
Pakiranja od 4 napunjene štrcaljke sa štitnikom za iglu.
Needle Cover (cap)
Poklopac igle (zatvarač)
In study PsA-II, the proportion of radiographic non-progressors (≤ 0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with abatacept 125 mg subcutaneous (42.7%) than placebo (32.7%) (10.0 [1.0, 19.1] estimate of difference [95% CI]).
U ispitivanju PsA-II, udio bolesnika bez radiografske progresije (promjena ≤ 0 u odnosu na početak ispitivanja) prema ukupnom Sharpovom/van der Heijdeovom rezultatu (SHS) prilagođenom za PsA na rendgenskim snimkama u 24. tjednu bio je veći u skupini liječenoj abataceptom u supkutanoj dozi od 125 mg (42,7%) nego u onoj koja je primala placebo (32,7%) (10,0 [1,0; 19,1] procjena razlike [95% CI]).
Immunogenicity in adults treated with intravenous abatacept
Imunogenost u odraslih bolesnika liječenih abataceptom primijenjenim intravenski
No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
U nizu in vitro ispitivanja nije opaženo mutageno ni klastogeno djelovanje abatacepta.
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Tijekom kombiniranog liječenja abataceptom i metotreksatom pokazana je redukcija progresije oštećenja zglobova i poboljšanje fizičke funkcije.
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.
ORENCIA se primjenjuje za liječenje reumatoidnog artritisa i psorijatičnog artritisa u odraslih osoba te poliartikularnog juvenilnog idiopatskog artritisa u djece u dobi od 6 ili više godina.
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.
ORENCIA se primjenjuje za liječenje reumatoidnog artritisa i psorijatičnog artritisa u odraslih osoba te poliartikularnog juvenilnog idiopatskog artritisa u djece u dobi od 2 ili više godina.
Age and gender (when corrected for body weight) did not affect apparent clearance.
Dob i spol (korigirani za tjelesnu težinu) nisu utjecali na prividni klirens.
It should be clear and colourless to pale yellow.
Mora biti bistra i bezbojna do blijedožuta.
ACR Pedi 30 responders at the end of Period A were randomised into Period B, the double-blind, withdrawal phase, to receive either abatacept or placebo for 6 months or until JIA flare.
A randomizirani su u Razdoblje B, dvostruko slijepu fazu ustezanja, tako da su primali ili abatacept ili placebo tijekom 6 mjeseci ili do razbuktavanja JIA-a.
*Note: the figure shows the 50 mg pre-filled syringe Proceed to Step 3
*Napomena: na slici je prikazana napunjena štrcaljka od 50 mg
ORENCIA SC should be administered weekly at a dose of 125 mg abatacept by subcutaneous injection regardless of weight (see section 5.1).
ORENCIA za supkutanu primjenu primjenjuje se supkutanom injekcijom u dozi od 125 mg abatacepta jedanput na tjedan, neovisno o tjelesnoj težini (vidjeti dio 5.1).
Improve your physical function and your ability to do normal daily activities.
ublažavanje znakova i simptoma bolesti usporavanje oštećenja kostiju i zglobova poboljšanje fizičke funkcije i sposobnosti obavljanja uobičajenih svakodnevnih aktivnosti.
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.
ORENCIA je u kombinaciji s metotreksatom indicirana za liječenje umjerenog do teškog oblika aktivnog poliartikularnog juvenilnog idiopatskog artritisa (pJIA) u pedijatrijskih bolesnika u dobi od 6 godina i starijih koji nisu dovoljno dobro odgovorili na prethodno liječenje DMARD-ima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AS INTERMEDIATE PACK (WITHOUT BLUE BOX) 1.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KAO MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA) 1. NAZIV LIJEKA
Injection reactions
Reakcije na injekciju
ORENCIA 87.5 mg solution for injection in pre-filled syringe with light blue plunger pack of 4 pre-filled syringes with needle guard.
ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki pakiranje od 4 napunjene štrcaljke sa štitnikom za iglu
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.
ORENCIA je u kombinaciji s metotreksatom indicirana za liječenje umjerenog do teškog oblika aktivnog poliartikularnog juvenilnog idiopatskog artritisa (pJIA) u pedijatrijskih bolesnika u dobi od 2 godine i starijih koji nisu dovoljno dobro odgovorili na prethodno liječenje DMARD-ima.
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.
Primarna mjera ishoda pokazala je neinferiornost (unaprijed određena granična vrijednost od 12%) odgovora ACR 20 nakon 12 mjeseci liječenja, sa 64,8% (206/318) bolesnika u skupini liječenoj abataceptom za supkutanu primjenu te 63,4% (208/328) bolesnika u skupini liječenoj adalimumabom za supkutanu primjenu; razlika između liječenja iznosila je 1,8% [95%-tni interval pouzdanosti (CI): 5,6; 9,2], a odgovori su bili usporedivi tijekom cijelog 24-mjesečnog razdoblja.
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.
U ispitivanje su uključena djeca i adolescenti s umjerenim do teškim oblikom aktivnog pJIA-a u dobi od 6 do 17 godina, koji nisu podnosili ili nisu dovoljno dobro odgovorili na barem jedan DMARD, koji je mogao biti i biološki lijek.
0.4 mL Fill line
0,4 ml Linija punjenja
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.
Srednja vrijednost (raspon) najnižih koncentracija abatacepta 113. dana iznosila je 46,2 μg/ml (13,4 - 96,2 μg/ml) u pedijatrijskih bolesnika s pJIA-om tjelesne težine od 10 do < 25 kg, 48,0 μg/ml (22,4 - 122,1 μg/ml) u onih tjelesne težine od 25 do < 50 kg i 38,5 μg/ml (9,3 - 73,2 μg/ml)u bolesnika tjelesne težine ≥ 50 kg.
The respective values for ACR 20 at 24 months were 59.7% (190/318) for the abatacept SC group and 60.1% (197/328) for the adalimumab SC group.
Odgovor ACR 20 je u 24. mjesecu postiglo 59,7% (190/318) bolesnika u skupini koja je primala abatacept za supkutanu primjenu te 60,1% (197/328) bolesnika u skupini koja je primala adalimumab za supkutanu primjenu.
If needed, you may cover the injection site with an adhesive plaster.
Ako je potrebno, možete ga prekriti flasterom.
Hold the pre-filled syringe by the body with the needle cover pointing down as shown.
Uhvatite napunjenu štrcaljku za tijelo, tako da je poklopac igle usmjeren prema dolje.
Proceed to Step 4
Prijeđite na 4. korak
Needle cover
Poklopac igle
DON'T recap the needle.
NEMOJTE vraćati poklopac na iglu.
Study SC-III: Induction of remission in methotrexate-naive RA patients
Ispitivanje SC-III: Indukcija remisije u bolesnika s RA koji prethodno nisu bili liječeni metotreksatom
Air Bubble
Mjehurić zraka
Do not store any unused portion of the infusion solution for reuse.
Neiskorišteni dio otopine ne smije se čuvati za ponovnu primjenu.
a DAS28-defined remission (DAS28-CRP <2.6) b SDAI criterion (SDAI ≤ 3.3)
a Remisija definirana prema indeksu DAS28 (DAS28-CRP < 2,6) b Prema pojednostavljenom indeksu aktivnosti bolesti (engl. simplified disease activity index, SDAI) (SDAI ≤ 3,3)
23% NA NA NA
23% ND ND ND
† 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 < 0,05, abatacept i MTX naspram MTX i placebo a Fiksna doza od približno 10 mg/kg (vidjeti dio 4.2).
Consistent with the results observed earlier in RA patients, population pharmacokinetic analyses for abatacept in PsA patients revealed that there was a trend toward higher clearance (L/h) of abatacept with increasing body weight.
U skladu s rezultatima već opaženima u bolesnika s RA, populacijske farmakokinetičke analize abatacepta u bolesnika s PsA otkrile su trend povećanja klirensa abatacepta (l/h) s povećanjem tjelesne težine.
The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Staklena štrcaljka (staklo tipa 1) ima obložen brombutilni čep i pričvršćenu iglu od nehrđajućeg čelika i tvrdi štitnik za iglu.
Psoriatic arthritis Adults
Psorijatični artritis Odrasli
50 mg 25 kg to less than 50kg 87.5mg 50 kg or more
50 mg od 25 kg do manje od 50 kg
In study VI, improvement was observed at 12 months in abatacept plus methotrexate group as compared with the methotrexate plus placebo group in both PCS and MCS, and was maintained through 2 years.
U ispitivanju VI je nakon 12 mjeseci zabilježeno poboljšanje i PCS-a i MCS-a u skupini liječenoj abataceptom i metotreksatom u usporedbi sa skupinom koja je primala metotreksat i placebo, koje se održalo tijekom 2 godine.
Proceed to Step 3
Prijeđite na 3. korak
Do not use ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati lijek ORENCIA: ako ste alergični na abatacept ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). ako imate tešku ili nekontroliranu infekciju, nemojte započinjati liječenje lijekom ORENCIA.
Proceed to Step 6
Prijeđite na 6. korak
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen (ClickJect)
4. FARMACEUTSKI OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici (ClickJect) 4 napunjene brizgalice ClickJect
At baseline 79% of 219 patients enrolled and treated in the study were taking methotrexate (mean dose at study entry, 12.3 mg/m2/week) and 21% of patients received abatacept monotherapy.
Na početku ispitivanja je 79% od 219 bolesnika uključenih i liječenih u sklopu ispitivanja uzimalo metotreksat (srednja vrijednost doze pri uključivanju u ispitivanje iznosila je 12,3 mg/m2 na tjedan), a
EU/1/07/389/011 4 pre-filled pens
EU/1/07/389/011 4 napunjene brizgalice
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.
Učestalost ozbiljnih infekcija i zloćudnih bolesti bila je, u odnosu na placebo, veća u bolesnika liječenih intravenski primijenjenim abataceptom starijih od 65 godina, nego u onih mlađih od 65 godina.
Serious adverse reactions were reported in 3.5% (11/318) and 6.1% (20/328) of the respective group.
Ozbiljne nuspojave prijavljene su u 3,5% (11/318) bolesnika liječenih abataceptom i 6,1% (20/328) bolesnika liječenih adalimumabom.
What you need to know before you use ORENCIA 3.
Što morate znati prije nego počnete primjenjivati lijek ORENCIA
A randomised, double-blind study was conducted to assess the safety and efficacy of intravenous abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (study V).
Provedeno je randomizirano, dvostruko slijepo ispitivanje sigurnosti i djelotvornosti intravenski infliksimaba naspram placeba u bolesnika koji nisu dovoljno dobro odgovorili na metotreksat (ispitivanje V).
- From a 100 mL infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/mL (0.9%)
- - Iz infuzijske vrećice ili boce od 100 ml izvucite volumen otopine natrijevog klorida za injekciju od 9 mg/ml (0,9%) jednak volumenu rekonstituiranih bočica.
How to use ORENCIA
Kako primjenjivati lijek ORENCIA
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.
PsA imali su blagu do umjerenu psorijazu i medijan PASI indeksa od 8,6 bodova u ispitivanju
Package leaflet: Information for the patient ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Uputa o lijeku: Informacije za bolesnika ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju abatacept
Proceed to Step 2
Prijeđite na 2. korak
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.
Učestalost ozbiljnih infekcija i zloćudnih bolesti bila je, u odnosu na placebo, veća u bolesnika liječenih abataceptom starijih od 65 godina, nego u onih mlađih od 65 godina.
Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.
Stoga se ne preporučuje primjena ORENCIA otopine za injekciju u napunjenoj brizgalici u ovoj populaciji bolesnika.
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.
Najčešće prijavljen oblik raka organa u placebom kontroliranim kliničkim ispitivanjima bio je rak pluća, čija je stopa incidencije iznosila 0,17 (0,05; 0,43) na 100 bolesnik-godina u bolesnika liječenih abataceptom, 0 u bolesnika koji su primali placebo te 0,12 (0,08; 0,17) na 100 bolesnik-godina u kumulativnom razdoblju.
Don't remove the needle cover until you are ready to inject ORENCIA.
Nemojte skidati poklopac igle dok niste spremni injicirati lijek ORENCIA.
15% NA NA NA
15% ND ND ND
DO NOT replace the cap on the used Pen.
NEMOJTE vraćati zatvarač na upotrijebljenu brizgalicu.
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).
U placebom kontroliranim kliničkim ispitivanjima učestalost zloćudnih bolesti iznosila je 1,2% u bolesnika liječenih abataceptom, a 0,9% u bolesnika koji su primali placebo (vidjeti dio 4.8).
DAS28-Remission a Odds Ratio (95% CI) vs. MTX P value
Omjer izgleda (95% CI) u odnosu na MTX P-vrijednost
Proceed to Step 1
Prijeđite na 1. korak
Uncommon Increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis
Poremećaji kože i potkožnog tkiva često osip (uključujući dermatitis) manje često povećana sklonost nastanku modrica, suha koža, alopecija, pruritus, urtikarija, psorijaza, akne, eritem, hiperhidroza
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.
Postotak bolesnika koji su postigli odgovor ACR 20, 50 ili 70 pri preporučenim dozama abatacepta u ispitivanjima PsA-I (10 mg/kg intravenski) i PsA-II (125 mg supkutano) naveden je u Tablici 7.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACK OF 1 VIAL
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJE OD 1 BOČICE
EU/1/07/389/004 1 pre-filled syringe EU/1/07/389/005 4 pre-filled syringes
EU/1/07/389/004 1 napunjena štrcaljka EU/1/07/389/005 4 napunjene štrcaljke