FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Sodium dihydrogen phosphate monohydrate Sodium chloride
Croatian: 6.1 Popis pomoćnih tvari maltoza natrijev dihidrogenfosfat, hidrat natrijev klorid
English: DO NOT use if past the expiry date.
Croatian: Nemojte je upotrijebiti ako je istekao rok valjanosti.
English: Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride 4.
Croatian: Pomoćne tvari: maltoza, natrijev dihidrogenfosfat hidrat i natrijev klorid 4. FARMACEUTSKI OBLIK I SADRŽAJ
English: 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.
Croatian: 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.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 87.5 mg abatacept in 0.7 mL.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 87,5 mg abatacepta u 0,7 ml.
English: Gently clean injection site
Croatian: Nježno očistite mjesto injekcije
English: Don't inject if the liquid is cloudy or discoloured, or has visible particles.
Croatian: Nemojte injicirati ako je tekućina mutna, ako je promijenila boju ili sadrži vidljive čestice.
English: Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, water for injections.
Croatian: Pomoćne tvari: saharoza, poloksamer 188, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat bezvodni, voda za injekcije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION ORENCIA 250 mg powder for concentrate for solution for infusion abatacept
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 250 mg prašak za koncentrat za otopinu za infuziju abatacept
English: 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.
Croatian: 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
English: Dose Vials
Croatian: Ubodite iglu
English: Package leaflet: Information for the patient ORENCIA 125 mg solution for injection in pre-filled pen abatacept
Croatian: Uputa o lijeku: Informacije za bolesnika ORENCIA 125 mg otopina za injekciju u napunjenoj brizgalici abatacept
English: 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.
Croatian: Međutim, omaglica je prijavljena kao česta, a smanjena oštrina vida kao manje česta nuspojava u bolesnika liječenih lijekom ORENCIA.
English: 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.
Croatian: 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.
English: DO NOT remove the orange needle cover until you are ready to inject.
Croatian: NEMOJTE skidati narančasti poklopac igle dok ne budete spremni za injiciranje.
English: 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.
Croatian: 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.
English: B. Keep a record of your injection
Croatian: Vodite bilješke o injekcijama
English: if you have cancer, your doctor will decide if you can still be given ORENCIA.
Croatian: 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.
English: 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
Croatian: 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
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje često trombocitopenija, leukopenija
English: 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
Croatian: 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
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACK (INCLUDING BLUE BOX) 1.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (UKLJUČUJUĆI PLAVI OKVIR) 1. NAZIV LIJEKA
English: If needed, you may cover the injection site with a small adhesive plaster.
Croatian: Ako je potrebno, možete zalijepiti mali flaster preko mjesta injekcije.
English: 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.
Croatian: 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).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 125 mg injection abatacept
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 125 mg injekcija abatacept s.c.
English: Period
Croatian: Kraj
English: Excipients: sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injections.
Croatian: Pomoćne tvari: saharoza, poloksamer 188, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat bezvodni, i voda za injekcije.
English: EU/1/07/389/013 4 pre-filled syringes with needle guard
Croatian: EU/1/07/389/013 4 napunjene štrcaljke sa štitnikom za iglu
English: 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).
Croatian: 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.
English: ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
Croatian: ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki sa štitnikom za iglu Abatacept
English: EU/1/07/389/014 4 pre-filled syringes with needle guard
Croatian: EU/1/07/389/014 4 napunjene štrcaljke sa štitnikom za iglu
English: Weekly Dose of ORENCIA Body Weight of Patient
Croatian: Tjedna doza lijeka ORENCIA
English: Month 6 Month 12 76%‡
Croatian: 3. mjesec 6. mjesec 12. mjesec
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 50 mg injection abatacept
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ORENCIA 50 mg injekcija abatacept s.c.
English: Abatacept SC+ MTX n = 119
Croatian: Abatacept za supkutanu primjenu + MTX n = 119
English: EU/1/07/389/009 12 pre-filled syringes with needle guard (3 packs of 4)
Croatian: EU/1/07/389/009 12 napunjenih štrcaljki sa štitnikom za iglu (3 pakiranja s 4 štrcaljke)
English: Rheumatoid arthritis Adults
Croatian: Reumatoidni artritis Odrasli
English: ORENCIA 50 mg solution for injection in pre-filled syringe The active substance is abatacept.
Croatian: ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar je abatacept.
English: responses, and 40% ACR 70 responses.
Croatian: 58% odgovor ACR50, a 44% odgovor ACR70.
English: DO NOT use the Pen if it is dropped after the cap is removed.
Croatian: NEMOJTE upotrijebiti brizgalicu ako Vam padne nakon što skinete zatvarač.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Intravenous use
Croatian: Intravenska formulacija
English: Do not use this medicine if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite neprozirne ili kakve druge strane čestice u otopini za infuziju, ili ako je promijenila boju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD 1.
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA PAKIRANJE OD 4 NAPUNJENE ŠTRCALJKE SA ŠTITNIKOM ZA IGLU 1. NAZIV LIJEKA
English: Uncommon Basal cell carcinoma, skin papilloma Rare
Croatian: manje često karcinom bazalnih stanica, kožni papilom rijetko limfom, zloćudna novotvorina pluća, karcinom skvamoznih stanica
English: 3 pre-filled syringes with needle guard
Croatian: 3 napunjene štrcaljke sa štitnikom za iglu
English: In study PsA-II, the ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who were TNF inhibitor-naive were 44.0% vs 22.2%, respectively (21.9 [8.3, 35.6], estimate of difference [95% CI]), and in patients who were TNF inhibitor-experienced were 36.4% vs 22.3%, respectively (14.0 [3.3, 24.8], estimate of difference [95% CI]).
Croatian: U ispitivanju PsA-II, među bolesnicima koji prethodno nisu bili liječeni TNF-inhibitorima odgovor ACR 20 postiglo je 44,0% bolesnika liječenih abataceptom u supkutanoj dozi od 125 mg i 22,2% onih koji su primali placebo (21,9 [8,3; 35,6], procjena razlike [95% CI]), dok je među bolesnicima prethodno liječenima TNF-inhibitorima isto zabilježeno u 36,4% odnosno 22,3% bolesnika (14,0 [3,3; 24,8], procjena razlike [95% CI]).
English: Consistent with the intravenous data, population pharmacokinetic analyses for subcutaneous abatacept in RA patients revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
Croatian: Sukladno podacima o intravenskoj primjeni, analize populacijske farmakokinetike za abatacept primijenjen supkutano otkrile su trend povećanja klirensa abatacepta s povećanjem tjelesne težine.
English: Patients switching from abatacept intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Croatian: U bolesnika koji prelaze s intravenskog liječenja abataceptom na supkutanu primjenu, prvu supkutanu dozu treba primijeniti umjesto sljedeće predviđene intravenske doze.
English: Check the Pen for damage.
Croatian: Provjerite je li brizgalica oštećena.
English: A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
Croatian: U placebom kontroliranim kliničkim ispitivanjima abatacept su primala ukupno 404 bolesnika u dobi od 65 ili više godina, uključujući i 67 bolesnika u dobi od 75 ili više godina.
English: Patients switching from ORENCIA intravenous therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled intravenous dose.
Croatian: U bolesnika koji prelaze s intravenskog liječenja lijekom ORENCIA na supkutanu primjenu, prvu supkutanu dozu treba primijeniti umjesto sljedeće predviđene intravenske doze.
English: ORENCIA 125 mg solution for injection in pre-filled syringe The active substance is abatacept.
Croatian: ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki Djelatna tvar je abatacept.
English: Each pre-filled syringe contains 125 mg of abatacept in one mL.
Croatian: Jedna napunjena brizgalica sadrži 125 mg abatacepta u jednom ml.
English: ORENCIA 50 mg solution for injection in pre-filled syringe
Croatian: ORENCIA 50 mg otopina za injekciju u napunjenoj štrcaljki
English: ORENCIA 125 mg solution for injection in pre-filled syringe
Croatian: ORENCIA 125 mg otopina za injekciju u napunjenoj štrcaljki
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 250 mg abatacept.
Croatian: 2. NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 250 mg abatacepta.
English: Don't pull back on the plunger at any time.
Croatian: NEMOJTE vraćati zatvarač na brizgalicu.
English: 1 silicone-free syringe
Croatian: 1 nesilikonska štrcaljka
English: In study I, ACR responses were assessed at 7 years in 43 patients with 72% ACR 20 responses, 58% ACR 50 responses, and 44% ACR 70 responses.
Croatian: U ispitivanju I, ACR odgovori su ocijenjeni nakon 7 godina u 43 bolesnika, pri čemu je njih 72% postiglo odgovor ACR20, 58% odgovor ACR50, a 44% odgovor ACR70.
English: Adhesive plaster
Croatian: Svjetloplavi klip
English: In study PsA-I, the proportion of patients with ≥ 0.30 decrease from baseline in HAQ-DI score was 45.0% with intravenous abatacept vs 19.0% with placebo (26.1 [6.8, 45.5], estimate of difference [95% CI]) at Week 24.
Croatian: PsA-I, udio bolesnika koji su postigli smanjenje početnog HAQ-DI indeksa za ≥ 0,30 bodova u 24. tjednu iznosio je 45,0% uz intravenski primijenjen abatacept i 19,0% uz placebo (26,1 [6,8; 45,5], procjena razlike [95% CI]).
English: DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard.
Croatian: Nemojte injicirati lijek u područje na kojem je koža osjetljiva, gdje su prisutne modrice, crvenilo, ljuskice ili otvrdnuća.
English: Immunogenicity in adults treated with subcutaneous abatacept
Croatian: Imunogenost u odraslih bolesnika liječenih abataceptom primijenjenim supkutano
English: Step 3: Check the Dose on the Pre-filled Syringe Hold the syringe at eye level.
Croatian: Provjerite tekućinu u napunjenoj štrcaljki Podignite štrcaljku do razine očiju.
English: 1 pre-filled syringe with needle guard
Croatian: 1 napunjene štrcaljke sa štitnikom za iglu
English: Common (may affect up to 1 in 10 people): infections of lungs, urinary infections, painful skin blisters (herpes), flu headache, dizziness high blood pressure cough abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting rash fatigue, weakness abnormal liver function tests
Croatian: Često (mogu se javiti u do 1 na 10 osoba): infekcije pluća, infekcije mokraćnih putova, bolni mjehurići na koži (herpes), gripa glavobolja, omaglica visok krvni tlak kašalj bolovi u trbuhu, proljev, mučnina, želučane tegobe, vrijedovi u ustima, povraćanje osip umor, slabost odstupanja u rezultatima testova jetrene funkcije
English: In study VI, ACR responses were assessed at 2 years in 232 patients with 85% ACR 20 responses, 74% ACR 50 responses, and 54% ACR 70 responses.
Croatian: ispitivanju VI, ACR odgovori su ocijenjeni nakon 2 godine u 232 bolesnika, pri čemu je njih 85% postiglo odgovor ACR20, 74% odgovor ACR50, a 54% odgovor ACR70.
English: Alcohol swab
Croatian: vata natopljena alkoholom flaster
English: 4 pre-filled syringes with needle guard
Croatian: 4 napunjene štrcaljke sa štitnikom za iglu
English: Do not inject into an area where the skin is tender, bruised, red, scaly, or hard.
Croatian: NEMOJTE injicirati lijek u područje na kojem je koža osjetljiva, gdje su prisutne modrice, crvenilo, ljuskanje ili otvrdnuća.
English: In study III the efficacy and safety of abatacept were assessed in patients with an inadequate response to a TNF-inhibitor, with the TNF-inhibitor discontinued prior to randomisation; other DMARDs were permitted.
Croatian: U ispitivanju III ispitivala se djelotvornost i sigurnost abatacepta u bolesnika koji nisu dovoljno dobro odgovorili na liječenje TNF-inhibitorom.
English: INJECT YOUR DOSE
Croatian: 3. INJICIRAJTE DOZU
English: Day 15 Month 3 64%††
Croatian: 3. mjesec 40%‡ 6. mjesec 53%† 12. mjesec 57%†
English: Common (may affect up to 1 in 10 people): infections of lungs, urinary infections, painful skin blisters (herpes), flu headache, dizziness high blood pressure cough abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting rash fatigue, weakness, injection site reactions abnormal liver function tests.
Croatian: Često (mogu se javiti u do 1 na 10 osoba): infekcije pluća, infekcije mokraćnih putova, bolni mjehurići na koži (herpes), gripa glavobolja, omaglica visok krvni tlak kašalj bolovi u trbuhu, proljev, mučnina, želučane tegobe, vrijedovi u ustima, povraćanje osip umor, slabost, reakcije na mjestu injekcije odstupanja u rezultatima testova jetrene funkcije
English: Remove the flip-top from the vial and wipe the top with an alcohol swab.
Croatian: Skinite poklopac s bočice i obrišite čep vatom natopljenom alkoholom.
English: A. Remove the needle cover (cap) only when you are ready to administer the injection.
Croatian: Skinite poklopac (zatvarač) s igle tek kad ste spremni primijeniti injekciju.
English: A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received intravenous abatacept in placebo-controlled clinical trials.
Croatian: U placebom kontroliranim kliničkim ispitivanjima abatacept su intravenski primala ukupno 404 bolesnika u dobi od 65 ili više godina, uključujući i 67 bolesnika u dobi od 75 ili više godina.
English: SDAI Clinical Remissionb Estimate of Difference (95% CI) vs. MTX
Croatian: Procijenjena razlika (95% CI) u odnosu na MTX
English: DO NOT remove the needle cover until you are ready to inject.
Croatian: NEMOJTE skidati poklopac igle dok ne budete spremni injicirati lijek.
English: ORENCIA powder for concentrate for solution for infusion is available for paediatric patients 6 years of age and older for the treatment of pJIA (see Summary of Product Characteristics for ORENCIA powder for concentrate for solution for infusion).
Croatian: Za liječenje pJIA-a u pedijatrijskih bolesnika u dobi od 6 ili više godina dostupan je ORENCIA prašak za koncentrat za otopinu za infuziju (vidjeti Sažetak opisa svojstava lijeka za ORENCIA prašak za koncentrat za otopinu za infuziju).
English: 5 How to store ORENCIA
Croatian: 3. Kako primjenjivati lijek ORENCIA