natgillin/translations-raw huggingface dataset:
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.
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.
ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger pack of 4 pre-filled syringes with needle guard.
ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki pakiranje od 4 napunjene štrcaljke sa štitnikom za iglu
Study V patients were randomised to receive this same fixed dose of abatacept or 3 mg/kg infliximab or placebo for 6 months.
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.
Fatigue, asthenia Uncommon Influenza like illness, weight increased
manje često bolest nalik influenci, povećanje tjelesne težine
Dose of ORENCIAa Body Weight of Patient
Tjelesna težina bolesnika
There have been reports of non-melanoma skin cancers in patients receiving ORENCIA (see section 4.8).
U bolesnika koji su primali lijek ORENCIA prijavljeni su nemelanomski oblici raka kože (vidjeti dio 4.8).
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).
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).
This medicinal product contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj.zanemarive količine natrija.
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).
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.
Two serious infections (varicella and sepsis) were reported during the initial 4 months of treatment with abatacept.
U prva 4 mjeseca liječenja abataceptom prijavljene su dvije ozbiljne infekcije (varičela i sepsa).
ORENCIA 87.5 mg solution for injection in pre-filled syringe
ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki
Remove Needle Cover
Skinite zatvarač igle
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
Srednja vrijednost razlike između liječenja abataceptom za supkutanu primjenu + MTX-om i samo MTX-om nakon 12 mjeseci liječenja (95% CI)*
EU/1/07/389/012 12 pre-filled pens (3 packs of 4)
EU/1/07/389/012 12 napunjenih brizgalica (3 pakiranja s 4 štrcaljke)
- You should be screened for certain infections prior to treatment with ORENCIA.
- Prije liječenja lijekom ORENCIA trebate se testirati na određene infekcije.
0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Napunjena štrcaljka volumena 0,7 ml (staklo tipa 1) s automatskim sigurnosnim štitnikom za iglu i proširenim rubnikom (svjetloplavi klip).
ACR 50 Month 3 Month 6 Month 12
15. dan 3. mjesec 6. mjesec 12. mjesec
EU/1/07/389/006 12 pre-filled syringes (3 packs of 4)
EU/1/07/389/006 12 napunjenih štrcaljki (3 pakiranja s 4 štrcaljke)
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.
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.
EU/1/07/389/001 1 vial and 1 silicone-free syringe
EU/1/07/389/001 1 bočica i 1 nesilikonska štrcaljka
Have your additional injection supplies ready before you inject.
Prije injiciranja pripremite dodatni pribor.
Viewing window
Prozor za provjeru
Higher ACR 20 responses in study PsA-II were seen with abatacept 125 mg subcutaneous vs. placebo irrespective of concomitant nonbiological DMARD treatment.
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.
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).
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).
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]).
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]).
In study SC-III, structural joint damage was assessed by MRI.
U ispitivanju SC-III, strukturno oštećenje zglobova ocjenjivalo se oslikavanjem magnetskom rezonancijom (engl. magnetic resonance imagining, MRI).
It should be clear to pale yellow.
Mora biti bistra do blijedožuta.
Fatigue, asthenia, local injection site reactions, systemic injection reactions* Uncommon Influenza like illness, weight increased
Opći poremećaji i reakcije na mjestu primjene često umor, astenija manje često bolest nalik influenci, povećanje tjelesne težine
ORENCIA 87.5 mg solution for injection in pre-filled syringe The active substance is abatacept.
ORENCIA 87,5 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar je abatacept.
Packs of 1 or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).
Pakiranja od 1 ili 4 napunjene štrcaljke i višestruko pakiranje koje sadrži 12 napunjenih štrcaljki (3 pakiranja po 4).
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.
Za pedijatrijske bolesnike s pJIA-om odobreni su ORENCIA prašak za koncentrat za otopinu za infuziju i ORENCIA otopina za injekciju u napunjenoj štrcaljki.
Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA.
Stoga prije započinjanja terapije lijekom ORENCIA treba obaviti testiranje na virusni hepatitis sukladno objavljenim smjernicama.
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.
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).
After reconstitution the solution should be clear and colourless to pale yellow.
Pripremljena otopina mora biti bistra i bezbojna do blijedožuta.
Study VI
Ispitivanje VI
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 mg abatacept in 0.4 mL.
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 50 mg abatacepta u 0,4 ml.
Headache, dizziness Uncommon Migraine, paraesthesia
Poremećaji živčanog sustava često glavobolja, omaglica manje često migrena, parestezije
Pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).
Pakiranje od 4 napunjene brizgalice i višestruko pakiranje koje sadrži 12 napunjenih brizgalica (3 pakiranja po 4).
The 125 mg/mL pre-filled syringe is shown below.
U nastavku je prikazana napunjena štrcaljka od 125 mg/ml.
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.
ORENCIA otopina za injekciju (injekcija) je bistra, bezbojna do blijedožuta otopina koja dolazi u napunjenoj brizgalici naziva ClickJect.
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.
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.
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]).
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]).
Subcutaneous
Supkutano
Acute infusion-related events that were reported in > 0.1% and ≤ 1% of patients treated with abatacept included cardiopulmonary symptoms such as hypotension, decreased blood pressure, tachycardia, bronchospasm, and dyspnea; other symptoms included myalgia, nausea, erythema, flushing, urticaria, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion related reaction, and rash.
Akutne reakcije vezane uz infuziju prijavljene u > 0,1% i ≤ 1% bolesnika liječenih abataceptom obuhvaćaju kardiopulmonalne simptome kao što su hipotenzija, snižen krvni tlak, tahikardija, bronhospazam i dispneja.
Consistent with the intravenous data, population pharmacokinetic analyses for subcutaneous abatacept in pJIA patients revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
U skladu s podacima za intravensku formulaciju, populacijske farmakokinetičke analize supkutane formulacije abatacepta u bolesnika s pJIA-om pokazale su trend povećanja klirensa abatacepta s porastom tjelesne težine.
Sodium dihydrogen phosphate monohydrate Sodium chloride
6.1 Popis pomoćnih tvari maltoza natrijev dihidrogenfosfat, hidrat natrijev klorid
DO NOT use if past the expiry date.
Nemojte je upotrijebiti ako je istekao rok valjanosti.
Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride 4.
Pomoćne tvari: maltoza, natrijev dihidrogenfosfat hidrat i natrijev klorid 4. FARMACEUTSKI OBLIK I SADRŽAJ
The most common hematologic malignancy was lymphoma 0.04 (0, 0.24) per 100 patient-years for abatacept-treated patients, 0 for placebo-treated patients, and 0.06 (0.03, 0.1) per 100 patient-years in the cumulative period.
Najčešći hematološki malignom bio je limfom, čija je stopa incidencije iznosila 0,04 (0; 0,24) na 100 bolesnik-godina u bolesnika liječenih abataceptom, 0 u bolesnika koji su primali placebo te 0,06 (0,03; 0,1) na 100 bolesnik-godina u kumulativnom razdoblju.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 87.5 mg abatacept in 0.7 mL.
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 87,5 mg abatacepta u 0,7 ml.
Gently clean injection site
Nježno očistite mjesto injekcije
Don't inject if the liquid is cloudy or discoloured, or has visible particles.
Nemojte injicirati ako je tekućina mutna, ako je promijenila boju ili sadrži vidljive čestice.
Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.
Pomoćne tvari: saharoza, poloksamer 188, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat bezvodni, voda za injekcije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju abatacept
The adjusted mean changes (standard error; SE) from baseline in DAS28-CRP were2.35 (SE 0.08) [95% CI: -2.51, -2.19] and -2.33 (SE 0.08) [95% CI: -2.50, -2.17] in the SC abatacept group and the adalimumab group, respectively, at 24 months, with similar changes over time.
U 24. tjednu je prilagođena srednja promjena (standardna greška; engl. standard error, SE) indeksa DAS28 CRP od početne vrijednosti iznosila 2,35 (SE 0,08) [95% CI: 2,51; 2,19] u skupini koja je primala abatacept za supkutanu primjenu te 2,33 (SE 0,08) [95% CI: 2,50; 2,17] u skupini koja je primala adalimumab, uz slične promjene tijekom vremena
Dose Vials
Ubodite iglu
Package leaflet: Information for the patient ORENCIA 125 mg solution for injection in pre-filled pen abatacept
Uputa o lijeku: Informacije za bolesnika ORENCIA 125 mg otopina za injekciju u napunjenoj brizgalici abatacept
However, dizziness and reduced visual acuity have been reported as common and uncommon adverse reactions respectively from patients treated with ORENCIA, therefore if a patient experiences such symptoms, driving and use of machinery should be avoided.
Međutim, omaglica je prijavljena kao česta, a smanjena oštrina vida kao manje česta nuspojava u bolesnika liječenih lijekom ORENCIA.
During period A, 74% were taking methotrexate (mean dose at study entry, 13.2 mg/m2/week) thus, 26% of patients received abatacept monotherapy in Period A. Of the 190 patients entering the study, 57 (30%) had previously been treated with TNF-inhibitor therapy.
Tijekom Razdoblja A je 74% bolesnika uzimalo metotreksat (prosječna doza pri uključivanju u ispitivanje 13,2 mg/m2 na tjedan), što znači da je njih 26% primalo monoterapiju abataceptom.
DO NOT remove the orange needle cover until you are ready to inject.
NEMOJTE skidati narančasti poklopac igle dok ne budete spremni za injiciranje.
Multipack: 2 vials and 2 silicone-free syringes (2 packs of 1) Multipack: 3 vials and 3 silicone-free syringes (3 packs of 1) 5.
Višestruko pakiranje: 2 bočice i 2 nesilikonske štrcaljke (2 pakiranja po 1) Višestruko pakiranje: 3 bočice i 3 nesilikonske štrcaljke (3 pakiranja po 1) 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
B. Keep a record of your injection
Vodite bilješke o injekcijama
if you have cancer, your doctor will decide if you can still be given ORENCIA.
ako bolujete od raka, liječnik će odlučiti možete li ipak primati lijek ORENCIA. ako ste se nedavno cijepili ili se planirate cijepiti, obavijestite o tome svog liječnika.
Uncommon (may affect up to 1 in 100 people): tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection low white blood cells count skin cancer, skin warts low blood platelet count allergic reactions depression, anxiety, sleep disturbance migraine numbness dry eye, reduced vision eye inflammation palpitation, rapid heart rate, low heart rate low blood pressure, hot flush, blood vessels inflammation, flushing difficulty in breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD) throat tightness rhinitis increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne hair loss, itching, hives painful joints pain in the extremities absence of menstruation, excessive menses flu-like illness, increased weight, infusion-related reactions
Manje često (mogu se javiti u do 1 na 100 osoba): infekcija zuba, gljivična infekcija noktiju, infekcije u mišićima, infekcije krvotoka, nakupljanje gnoja ispod kože, infekcija bubrega, infekcija uha malen broj bijelih krvnih stanica rak kože, kožne bradavice nizak broj krvnih pločica alergijske reakcije depresija, tjeskoba, poremećaj spavanja migrena utrnulost suhe oči, smanjen vid upala oka osjećaj lupanja srca, ubrzani srčani otkucaji, usporeni srčani otkucaji nizak krvni tlak, navale vrućine, upala krvnih žila, navale crvenila otežano disanje, piskanje pri disanju, nedostatak zraka, akutno pogoršanje plućne bolesti koja se zove kronična opstruktivna plućna bolest (KOPB) stezanje u grlu hunjavica povećana sklonost stvaranju modrica, suha koža, psorijaza, crvenilo kože, prekomjerno znojenje, akne gubitak kose, svrbež, koprivnjača bolni zglobovi bol u udovima izostanak menstruacije, preobilne menstruacije, bolest nalik gripi, povećanje tjelesne težine, reakcije vezane uz infuziju
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava manje često trombocitopenija, leukopenija
Uncommon (may affect up to 1 in 100 people): tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection low white blood cells count skin cancer, skin warts low blood platelet count allergic reactions depression, anxiety, sleep disturbance migraine numbness dry eye, reduced vision eye inflammation palpitation, rapid heart rate, low heart rate low blood pressure, hot flush, blood vessels inflammation, flushing difficulty in breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD) throat tightness rhinitis increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne hair loss, itching, hives painful joints pain in the extremities absence of menstruation, excessive menses flu-like illness, increased weight
Manje često (mogu se javiti u do 1 na 100 osoba): infekcija zuba, gljivična infekcija noktiju, infekcije u mišićima, infekcije krvotoka, nakupljanje gnoja ispod kože, infekcija bubrega, infekcija uha rak kože, kožne bradavice nizak broj bijelih krvnih stanica nizak broj krvnih pločica alergijske reakcije depresija, tjeskoba, poremećaj spavanja migrena utrnulost suhe oči, smanjen vid upala oka osjećaj lupanja srca, ubrzani srčani otkucaji, usporeni srčani otkucaji nizak krvni tlak, navale vrućine, upala krvnih žila, navale crvenila otežano disanje, piskanje pri disanju, nedostatak zraka, akutno pogoršanje plućne bolesti koja se zove kronična opstruktivna plućna bolest (KOPB) stezanje u grlu hunjavica povećana sklonost stvaranju modrica, suha koža, psorijaza, crvenilo kože, prekomjerno znojenje, akne gubitak kose, svrbež, koprivnjača bolni zglobovi bol u udovima izostanak menstruacije, preobilne menstruacije, bolest nalik gripi, povećanje tjelesne težine
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (INCLUDING BLUE BOX) 1.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (UKLJUČUJUĆI PLAVI OKVIR) 1. NAZIV LIJEKA
If needed, you may cover the injection site with a small adhesive plaster.
Ako je potrebno, možete zalijepiti mali flaster preko mjesta injekcije.
The mean change was, 0.41 and 0.74 from year 1 to year 2 (n=290, 130), 0.37 and 0.68 from year 2 to year 3 (n=293, 130), 0.34 and 0.43 from year 3 to year 4 (n=290, 128) and the change was 0.26 and 0.29 (n=233, 114) from year 4 to year 5 for patients originally randomised to abatacept plus MTX and placebo plus MTX respectively.
MTX, prosječna promjena od 1. do 2. godine iznosila je 0,41 (n=290), od 2. do 3. godine 0,37 (n=293), od 3. do 4. godine 0,34 (n=290), a od 4. do 5. godine 0,26 (n=233).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 125 mg injection abatacept
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 125 mg injekcija abatacept s.c.
Period
Kraj
Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections.
Pomoćne tvari: saharoza, poloksamer 188, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat bezvodni, i voda za injekcije.
EU/1/07/389/013 4 pre-filled syringes with needle guard
EU/1/07/389/013 4 napunjene štrcaljke sa štitnikom za iglu
Over the 2 year study period, 3.8 % (12/318) and 1.5 % (5/328) patients treated with abatacept SC and adalimumab SC respectively reported autoimmune disorders mild to moderate in severity (e.g., psoriasis, Raynaud's phenomenon, erythema nodosum).
Tijekom 2-godišnjeg razdoblja ispitivanja, autoimune poremećaje blage do umjerene težine (npr. psorijazu, Raynaudov fenomen, nodozni eritem) prijavilo je 3,8% (12/318) bolesnika liječenih abataceptom za supkutanu primjenu te 1,5% (5/328) bolesnika liječenih adalimumabom za supkutanu primjenu.
ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki sa štitnikom za iglu Abatacept
EU/1/07/389/014 4 pre-filled syringes with needle guard
EU/1/07/389/014 4 napunjene štrcaljke sa štitnikom za iglu
Weekly Dose of ORENCIA Body Weight of Patient
Tjedna doza lijeka ORENCIA
Month 6 Month 12 76%‡
3. mjesec 6. mjesec 12. mjesec
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 50 mg injection abatacept
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 50 mg injekcija abatacept s.c.
Abatacept SC+ MTX n = 119
Abatacept za supkutanu primjenu + MTX n = 119
EU/1/07/389/009 12 pre-filled syringes with needle guard (3 packs of 4)
EU/1/07/389/009 12 napunjenih štrcaljki sa štitnikom za iglu (3 pakiranja s 4 štrcaljke)
Rheumatoid arthritis Adults
Reumatoidni artritis Odrasli
ORENCIA 50 mg solution for injection in pre-filled syringe The active substance is abatacept.
ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar je abatacept.
responses, and 40% ACR 70 responses.
58% odgovor ACR50, a 44% odgovor ACR70.
DO NOT use the Pen if it is dropped after the cap is removed.
NEMOJTE upotrijebiti brizgalicu ako Vam padne nakon što skinete zatvarač.
In study II, ACR responses were assessed at 5 years in 270 patients with 84% ACR 20 responses, 61% ACR 50 responses, and 40% ACR 70 responses.
U ispitivanju II, ACR odgovori su ocijenjeni nakon 5 godina u 270 bolesnika, pri čemu je njih 84% postiglo odgovor ACR20, 61% odgovor ACR50, a 40% odgovor ACR70.
A significantly higher proportion of patients achieved an ACR 20 response after treatment with abatacept 10 mg/kg intravenous in PsA-I or 125 mg subcutaneous in PsA-II compared to placebo at Week 24 in the overall study populations.
U cjelokupnoj je ispitivanoj populaciji značajno veći udio bolesnika postigao odgovor ACR 20 u 24. tjednu nakon liječenja abataceptom u dozi od 10 mg/kg intravenski (PsA-I) ili 125 mg supkutano (PsA-II) nego nakon primjene placeba.
Intravenous use
Intravenska formulacija
Do not use this medicine if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.
Ovaj lijek se ne smije upotrijebiti ako primijetite neprozirne ili kakve druge strane čestice u otopini za infuziju, ili ako je promijenila boju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD 1.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJE OD 4 NAPUNJENE ŠTRCALJKE SA ŠTITNIKOM ZA IGLU 1. NAZIV LIJEKA
Uncommon Basal cell carcinoma, skin papilloma Rare
manje često karcinom bazalnih stanica, kožni papilom rijetko limfom, zloćudna novotvorina pluća, karcinom skvamoznih stanica
3 pre-filled syringes with needle guard
3 napunjene štrcaljke sa štitnikom za iglu