FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AS INTERMEDIATE PACK (WITHOUT BLUE BOX) 1.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KAO MEĐUPAKIRANJE (BEZ PLAVOG OKVIRA) 1. NAZIV LIJEKA
English: Injection reactions
Croatian: Reakcije na injekciju
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe with light blue plunger pack of 4 pre-filled syringes with needle guard.
Croatian: ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki pakiranje od 4 napunjene štrcaljke sa štitnikom za iglu
English: 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.
Croatian: 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.
English: The primary endpoint showed noninferiority (predefined margin of 12%) of ACR 20 response after 12 months of treatment, 64.8% (206/318) for the abatacept SC group and 63.4% (208/328) for the adalimumab SC group; treatment difference was 1.8% [95% confidence interval (CI): -5.6, 9.2], with comparable responses throughout the 24-month period.
Croatian: 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.
English: 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.
Croatian: 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.
English: 0.4 mL Fill line
Croatian: 0,4 ml Linija punjenja
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: If needed, you may cover the injection site with an adhesive plaster.
Croatian: Ako je potrebno, možete ga prekriti flasterom.
English: Hold the pre-filled syringe by the body with the needle cover pointing down as shown.
Croatian: Uhvatite napunjenu štrcaljku za tijelo, tako da je poklopac igle usmjeren prema dolje.
English: Proceed to Step 4
Croatian: Prijeđite na 4. korak
English: Needle cover
Croatian: Poklopac igle
English: DON'T recap the needle.
Croatian: NEMOJTE vraćati poklopac na iglu.
English: Study SC-III: Induction of remission in methotrexate-naive RA patients
Croatian: Ispitivanje SC-III: Indukcija remisije u bolesnika s RA koji prethodno nisu bili liječeni metotreksatom
English: Air Bubble
Croatian: Mjehurić zraka
English: Do not store any unused portion of the infusion solution for reuse.
Croatian: Neiskorišteni dio otopine ne smije se čuvati za ponovnu primjenu.
English: a DAS28-defined remission (DAS28-CRP <2.6) b SDAI criterion (SDAI ≤ 3.3)
Croatian: 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)
English: 23% NA NA NA
Croatian: 23% ND ND ND
English: † p < 0.05, abatacept plus MTX vs MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
Croatian: *** 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).
English: 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.
Croatian: 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.
English: The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Croatian: Staklena štrcaljka (staklo tipa 1) ima obložen brombutilni čep i pričvršćenu iglu od nehrđajućeg čelika i tvrdi štitnik za iglu.
English: Psoriatic arthritis Adults
Croatian: Psorijatični artritis Odrasli
English: 50 mg 25 kg to less than 50kg 87.5mg 50 kg or more
Croatian: 50 mg od 25 kg do manje od 50 kg
English: 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.
Croatian: 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.
English: Proceed to Step 3
Croatian: Prijeđite na 3. korak
English: Do not use ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).
Croatian: 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.
English: Proceed to Step 6
Croatian: Prijeđite na 6. korak
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen (ClickJect)
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj brizgalici (ClickJect) 4 napunjene brizgalice ClickJect
English: 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.
Croatian: 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
English: EU/1/07/389/011 4 pre-filled pens
Croatian: EU/1/07/389/011 4 napunjene brizgalice
English: 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.
Croatian: 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.
English: Serious adverse reactions were reported in 3.5% (11/318) and 6.1% (20/328) of the respective group.
Croatian: Ozbiljne nuspojave prijavljene su u 3,5% (11/318) bolesnika liječenih abataceptom i 6,1% (20/328) bolesnika liječenih adalimumabom.
English: What you need to know before you use ORENCIA 3.
Croatian: Što morate znati prije nego počnete primjenjivati lijek ORENCIA
English: 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).
Croatian: Provedeno je randomizirano, dvostruko slijepo ispitivanje sigurnosti i djelotvornosti intravenski infliksimaba naspram placeba u bolesnika koji nisu dovoljno dobro odgovorili na metotreksat (ispitivanje V).
English: - From a 100 mL infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/mL (0.9%)
Croatian: - - 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.
English: How to use ORENCIA
Croatian: Kako primjenjivati lijek ORENCIA
English: Patients entering the two PsA studies had mild to moderate psoriasis with median PASI scores of 8.6 in PsA-I and 4.5 in PsA-II.
Croatian: PsA imali su blagu do umjerenu psorijazu i medijan PASI indeksa od 8,6 bodova u ispitivanju
English: Package leaflet: Information for the patient ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Croatian: Uputa o lijeku: Informacije za bolesnika ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju abatacept
English: Proceed to Step 2
Croatian: Prijeđite na 2. korak
English: 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.
Croatian: 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.
English: Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.
Croatian: Stoga se ne preporučuje primjena ORENCIA otopine za injekciju u napunjenoj brizgalici u ovoj populaciji bolesnika.
English: 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.
Croatian: 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.
English: Don't remove the needle cover until you are ready to inject ORENCIA.
Croatian: Nemojte skidati poklopac igle dok niste spremni injicirati lijek ORENCIA.
English: 15% NA NA NA
Croatian: 15% ND ND ND
English: DO NOT replace the cap on the used Pen.
Croatian: NEMOJTE vraćati zatvarač na upotrijebljenu brizgalicu.
English: In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebotreated patients were 1.2% and 0.9%, respectively (see section 4.8).
Croatian: 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).
English: DAS28-Remission a Odds Ratio (95% CI) vs. MTX P value
Croatian: Omjer izgleda (95% CI) u odnosu na MTX P-vrijednost
English: Proceed to Step 1
Croatian: Prijeđite na 1. korak
English: Uncommon Increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva često osip (uključujući dermatitis) manje često povećana sklonost nastanku modrica, suha koža, alopecija, pruritus, urtikarija, psorijaza, akne, eritem, hiperhidroza
English: 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.
Croatian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACK OF 1 VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJE OD 1 BOČICE
English: EU/1/07/389/004 1 pre-filled syringe EU/1/07/389/005 4 pre-filled syringes
Croatian: EU/1/07/389/004 1 napunjena štrcaljka EU/1/07/389/005 4 napunjene štrcaljke
English: 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.
Croatian: 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 8.
English: ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger pack of 4 pre-filled syringes with needle guard.
Croatian: ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki pakiranje od 4 napunjene štrcaljke sa štitnikom za iglu
English: Study V patients were randomised to receive this same fixed dose of abatacept or 3 mg/kg infliximab or placebo for 6 months.
Croatian: V bolesnici su randomizirani tako da su tijekom 6 mjeseci primali abatacept u istoj toj fiksnoj dozi, infliksimab u dozi od 3 mg/kg ili placebo.
English: Fatigue, asthenia Uncommon Influenza like illness, weight increased
Croatian: manje često bolest nalik influenci, povećanje tjelesne težine
English: Dose of ORENCIAa Body Weight of Patient
Croatian: Tjelesna težina bolesnika
English: There have been reports of non-melanoma skin cancers in patients receiving ORENCIA (see section 4.8).
Croatian: U bolesnika koji su primali lijek ORENCIA prijavljeni su nemelanomski oblici raka kože (vidjeti dio 4.8).
English: Packs of 1, 3 or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Croatian: Pakiranja od 1, 3 ili 4 napunjene štrcaljke sa štitnikom za iglu i višestruko pakiranje koje sadrži 12 napunjenih štrcaljki sa štitnikom za iglu (3 pakiranja po 4).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj.zanemarive količine natrija.
English: 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).
Croatian: Ne smijete primiti 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.
English: Two serious infections (varicella and sepsis) were reported during the initial 4 months of treatment with abatacept.
Croatian: U prva 4 mjeseca liječenja abataceptom prijavljene su dvije ozbiljne infekcije (varičela i sepsa).
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe
Croatian: ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki
English: Remove Needle Cover
Croatian: Skinite zatvarač igle
English: Structural and inflammatory MRI assessment in study SC-III Mean Treatment Difference between Abatacept SC+MTX vs. MTX at 12 Months (95% CI)* MRI Erosion Score
Croatian: Srednja vrijednost razlike između liječenja abataceptom za supkutanu primjenu + MTX-om i samo MTX-om nakon 12 mjeseci liječenja (95% CI)*
English: EU/1/07/389/012 12 pre-filled pens (3 packs of 4)
Croatian: EU/1/07/389/012 12 napunjenih brizgalica (3 pakiranja s 4 štrcaljke)
English: - You should be screened for certain infections prior to treatment with ORENCIA.
Croatian: - Prije liječenja lijekom ORENCIA trebate se testirati na određene infekcije.
English: 0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Croatian: Napunjena štrcaljka volumena 0,7 ml (staklo tipa 1) s automatskim sigurnosnim štitnikom za iglu i proširenim rubnikom (svjetloplavi klip).
English: ACR 50 Month 3 Month 6 Month 12
Croatian: 15. dan 3. mjesec 6. mjesec 12. mjesec
English: EU/1/07/389/006 12 pre-filled syringes (3 packs of 4)
Croatian: EU/1/07/389/006 12 napunjenih štrcaljki (3 pakiranja s 4 štrcaljke)
English: 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.
Croatian: Najčešće prijavljena zloćudna bolest u placebom kontroliranim kliničkim ispitivanjima bio je nemelanomski rak kože, čija je stopa incidencije iznosila 0,6 (0,3; 1,0) na 100 bolesnik-godina u bolesnika liječenih abataceptom, 0,4 (0,1; 0,9) na 100 bolesnik-godina u bolesnika koji su primali placebo te 0,5 (0,4; 0,6) na 100 bolesnik-godina u kumulativnom razdoblju.
English: EU/1/07/389/001 1 vial and 1 silicone-free syringe
Croatian: EU/1/07/389/001 1 bočica i 1 nesilikonska štrcaljka
English: Have your additional injection supplies ready before you inject.
Croatian: Prije injiciranja pripremite dodatni pribor.
English: Viewing window
Croatian: Prozor za provjeru
English: Higher ACR 20 responses in study PsA-II were seen with abatacept 125 mg subcutaneous vs. placebo irrespective of concomitant nonbiological DMARD treatment.
Croatian: U ispitivanju PsA-II, više stope odgovora ACR 20 uz abatacept u supkutanoj dozi od 125 mg nego uz placebo opažene su neovisno o istodobnom liječenju nebiološkim DMARD-ima.
English: Pack of 1 vial and 1 silicone-free syringe (polyethylene), and multipacks containing 2, or 3 vials and 2, or 3 silicone-free syringes (2 or 3 packs of 1).
Croatian: Pakiranje od 1 bočice i 1 nesilikonske štrcaljke (polietilen) i višestruka pakiranja koja sadrže 2, odnosno 3 bočice i 2, odnosno 3 nesilikonske štrcaljke (2 ili 3 pakiranja po 1).
English: In study PsA-I, the proportions of patients achieving PASI 50 response was 28.6% with abatacept vs. 14.3% with placebo (14.3 [-15.3, 43.9], estimate of difference [95% CI]), and the proportion of patients who achieved PASI 75 response was 14.3% with abatacept vs. 4.8% with placebo (9.5 [-13.0, 32.0], estimate of difference [95% CI]).
Croatian: PsA-I, udio bolesnika koji su postigli odgovor PASI 50 iznosio je 28,6% uz abatacept i 14,3% uz placebo (14,3 [-15,3; 43,9], procjena razlike [95% CI]), dok je udio bolesnika koji su postigli odgovor PASI 75 iznosio 14,3% uz abatacept odnosno 4,8% uz placebo (9,5 [-13,0; 32,0], procjena razlike [95% CI]).
English: In study SC-III, structural joint damage was assessed by MRI.
Croatian: U ispitivanju SC-III, strukturno oštećenje zglobova ocjenjivalo se oslikavanjem magnetskom rezonancijom (engl. magnetic resonance imagining, MRI).
English: It should be clear to pale yellow.
Croatian: Mora biti bistra do blijedožuta.
English: Fatigue, asthenia, local injection site reactions, systemic injection reactions* Uncommon Influenza like illness, weight increased
Croatian: Opći poremećaji i reakcije na mjestu primjene često umor, astenija manje često bolest nalik influenci, povećanje tjelesne težine
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe The active substance is abatacept.
Croatian: ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar je abatacept.
English: Packs of 1 or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).
Croatian: Pakiranja od 1 ili 4 napunjene štrcaljke i višestruko pakiranje koje sadrži 12 napunjenih štrcaljki (3 pakiranja po 4).
English: ORENCIA powder for concentrate for solution for infusion and ORENCIA solution for injection in pre-filled syringe are approved in the paediatric patients with pJIA.
Croatian: Za pedijatrijske bolesnike s pJIA-om odobreni su ORENCIA prašak za koncentrat za otopinu za infuziju i ORENCIA otopina za injekciju u napunjenoj štrcaljki.
English: Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA.
Croatian: Stoga prije započinjanja terapije lijekom ORENCIA treba obaviti testiranje na virusni hepatitis sukladno objavljenim smjernicama.
English: 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.
Croatian: Nakon 6 mjeseci je incidencija infekcija kao nuspojave u skupini liječenoj abataceptom iznosila 48,1% (75), u skupini liječenoj infliksimabom 52,1% (86), a u skupini koja je primala placebo 51,8% (57).
English: After reconstitution the solution should be clear and colourless to pale yellow.
Croatian: Pripremljena otopina mora biti bistra i bezbojna do blijedožuta.
English: Study VI
Croatian: Ispitivanje VI
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 mg abatacept in 0.4 mL.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 50 mg abatacepta u 0,4 ml.
English: Headache, dizziness Uncommon Migraine, paraesthesia
Croatian: Poremećaji živčanog sustava često glavobolja, omaglica manje često migrena, parestezije
English: Pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).
Croatian: Pakiranje od 4 napunjene brizgalice i višestruko pakiranje koje sadrži 12 napunjenih brizgalica (3 pakiranja po 4).
English: The 125 mg/mL pre-filled syringe is shown below.
Croatian: U nastavku je prikazana napunjena štrcaljka od 125 mg/ml.
English: What ORENCIA looks like and contents of the pack ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution provided in a pre-filled pen called ClickJect.
Croatian: ORENCIA otopina za injekciju (injekcija) je bistra, bezbojna do blijedožuta otopina koja dolazi u napunjenoj brizgalici naziva ClickJect.
English: In study III, ACR responses were assessed at 5 years in 91 patients with 74% ACR 20 responses, 51% ACR 50 responses, and 23% ACR 70 responses.
Croatian: U ispitivanju III, ACR odgovori su ocijenjeni nakon 5 godina u 91 bolesnika, pri čemu je njih 74% postiglo odgovor ACR20, 51% odgovor ACR50, a 23% odgovor ACR70.
English: In study PsA-II, the proportion of patients with at least ≥ 0.35 decrease from baseline in HAQ-DI was 31.0% with abatacept vs. 23.7% with placebo (7.2 [-1.1, 15.6], estimate of difference [95% CI]).
Croatian: U ispitivanju PsA-II, udio bolesnika koji su postigli smanjenje početnog HAQ-DI indeksa za najmanje ≥ 0,35 bodova iznosio je 31,0% uz abatacept i 23,7% uz placebo (7,2 [-1,1; 15,6], procjena razlike [95% CI]).
English: Subcutaneous
Croatian: Supkutano