FrancophonIA/ELRC3.0 huggingface dataset:
English: • two pre-filled syringes of solution, and
Croatian: • dvije otopinom napunjene štrcaljke i
English: Each pre-filled syringe contains 200 mg of certolizumab pegol in one ml.
Croatian: Jedna napunjena brizgalica sadrži 200 mg certolizumabpegola u jednom ml.
English: Activated partial thromboplastin time (aPTT) assay Interference with certain coagulation assays has been detected in patients treated with Cimzia.
Croatian: U bolesnika koji se liječe Cimzijom uočena je interferencija s određenim testovima koagulacije.
English: Cimziaa 200 mg every 2 weeks N=159
Croatian: Cimzia 200 mg svaka dva tjedna N=95
English: Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
Croatian: Tijekom primjene TNF-antagonista rijetko su zabilježeni slučajevi pancitopenije, uključujući aplastičnu anemiju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes with needle guard and 2 alcohol wipes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija (za pakiranja od 2 napunjene štrcaljke sa štitnikom za iglu i 2 alkoholne vatice)
English: - One or two pre-filled syringe(s), depending on your prescribed dose - One or two alcohol wipe(s)
Croatian: jednu ili dvije napunjene štrcaljke, ovisno o propisanoj dozi jednu ili dvije alkoholne vatice
English: • “Remove and save needle cap” is shown.
Croatian: • Prikazuje se poruka „Skinite i spremite zatvarač igle“.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 200 mg certolizumabpegola u jednom ml.
English: • The starting dose for adults with psoriatic arthritis is 400 mg given at weeks 0, 2 and 4.
Croatian: • Početna doza za odrasle s psorijatičnim artritisom je 400 mg, a primjenjuje se u 0., 2., i 4. tjednu.
English: The efficacy and safety of Cimzia have been assessed in 2 randomised, placebo-controlled, doubleblind clinical trials in patients ≥ 18 years of age with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria, RA-I (RAPID 1) and RA-II (RAPID 2).
Croatian: Djelotvornost i sigurnost Cimzije ocjenjivana je u 2 randomizirana, placebom kontrolirana, dvostruko slijepa klinička istraživanja RA-I (RAPID 1) i RA-II (RAPID 2), koja su uključila bolesnike u dobi
English: Ankylosing spondylitis Non-radiographic axial spondyloarthritits
Croatian: Neradiografski aksijalni spondiloartritis
English: Solution for injection in a pre-filled pen (AutoClicks) 2 single-use AutoClicks pre-filled pens 2 alcohol wipes.
Croatian: Otopina za injekciju u napunjenoj brizgalici (AutoClicks) 2 napunjene brizgalice za jednokratnu uporabu (AutoClicks) 2 alkoholne vatice
English: Cimzia 200 mg Q2W a) N=165
Croatian: Cimzia 200 mg svaka dva tjedna a) N=165
English: • Do not shake the medication.
Croatian: • Nemojte protresati uložak.
English: In C-EARLY, Cimzia+MTX-treated patients reported significant improvements at Week 52 compared to placebo+MTX in pain as assessed by the Patient Assessment of Arthritis Pain (PAAP) - 48,5 vs44,0 (least square mean) (p<0.05).
Croatian: U C-EARLY ispitivanju, u bolesnika liječenih Cimzijom+MTX zabilježeno je značajno smanjenje boli u 52. tjednu koja je ocijenjena bolesnikovom ocjenom boli uzrokovane artritisom (PAAP, engl.
English: Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinal pain ≥ 4 on a 0 to 10 Numerical Rating Scale (NRS) and increased CRP or current evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).
Croatian: Bath Ankylosing Spondylitis Disease Activity Index) ≥ 4, spinalna bol ≥ 4 na numeričkoj ljestvici ocjenjivanja (NRS, engl.
English: Uncommo anxiety and mood disorders (including associated symptoms)
Croatian: Poremećaji metabolizma i prehrane rijetko hemosideroza manje često anksioznost i poremećaji raspoloženja (uključujući pripadajuće simptome)
English: Cimzia 200 mg Q2W a) N=95
Croatian: Cimzia 200 mg svaka dva tjedna a) N=95
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/008
English: Tell your doctor AS SOON AS POSSIBLE if you notice any of the following side effects:
Croatian: Ako primijetite neku od sljedećih nuspojava, ČIM PRIJE o tome obavijestite svog liječnika:
English: Physical function response and health-related outcomes In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
Croatian: U PsA001 kliničkom istraživanju u usporedbi s placebom u skupini bolesnika liječenih Cimzijom zabilježena su značajna poboljšanja fizikalne funkcije ocijenjeno Upitnikom za procjenu zdravljaindeks nesposobnosti (HAQ-DI, engl.
English: Do not use Cimzia after the expiry date which is stated on the pack and syringe after EXP.
Croatian: Nemojte primijeniti Cimziju nakon isteka roka valjanosti navedenog na pakiranju i štrcaljki iza kratice EXP.
English: • symptoms of blood disorders such as persistent fever, bruising, bleeding, paleness
Croatian: • simptomi poremećaja krvi kao što su dugotrajna vrućica, modrice, krvarenje, bljedilo (pancitopenija, anemija, smanjeni broj krvnih pločica, smanjeni broj bijelih krvnih stanica).
English: Cimzia 200 mg Q2W a) N=91
Croatian: Cimzia 200 mg svaka dva tjedna a) N=91
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 mg certolizumab pegol in one ml.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica sadrži 200 mg certolizumabpegola u jednom ml.
English: Needle cap
Croatian: Učestalost Nuspojave
English: • Allow the medication to reach room temperature.
Croatian: • Prije injiciranja pričekajte da se uložak ugrije na sobnu temperaturu.
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in pre-filled pen
Croatian: NAZIV LIJEKA Cimzia 200 mg otopina za injekciju u napunjenoj brizgalici
English: Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Croatian: Otopina za injekciju u ulošku za dozator 2 uloška za dozator za jednokratnu uporabu 2 alkoholne vatice
English: It is important that you tell your baby's doctors and other health care professionals about your Cimzia use before the baby receives any vaccine (for more information see section on vaccinations).
Croatian: Vaše dijete primi bilo koje cjepivo (za više informacija vidjeti dio o cijepljenju).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose-dispenser cartridge contains 200 mg certolizumab pegol in one ml.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan uložak za dozator sadrži 200 mg certolizumabpegola u jednom ml.
English: Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Cimzia.
Croatian: Nakon primjene Cimzije može se javiti omaglica (uključujući osjećaj da se soba okreće, zamagljen vid i umor).
English: p value was estimated from an ANCOVA model on the ranks with treatment, region, time since RA diagnosis at Baseline (≤4 months vs >4 months) as factors and Baseline rank as a covariate.
Croatian: **Cimzia+MTX naspram placebo+MTX p<0,001. p vrijednost je procijenjena na osnovu ANCOVA modela s vrijednostima za liječenje, regiju i vrijeme od postavljanja dijagnoze RA na početku (≤4 mjeseca naspram >4 mjeseca) kao faktorima te početnom vrijednošću kao kovarijancom.
English: • Look at the expiry date on the pack and dose tray.
Croatian: • Provjerite rok valjanosti na pakiranju i doznom spremniku.
English: If you received Cimzia during your pregnancy, your baby may have a higher risk for getting an infection.
Croatian: Vaše dijete može imati povišeni rizik od dobivanja infekcije.
English: Medication body
Croatian: NAČIN PRIMJENE LIJEKA
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u ulošku za dozator 2 uloška za dozator za jednokratnu uporabu 2 alkoholne vatice
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack of 10 (5 packs of 2 pre-filled syringes and 2 alcohol wipes) (with bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Višestruko pakiranje od 10 (5 pakiranja od 2 napunjene štrcaljke i 2 alkoholne vatice) (s plavim okvirom)
English: Discontinuation of Cimzia therapy should be considered in patients with confirmed significant haematological abnormalities.
Croatian: U bolesnika u kojih su potvrđene značajne hematološke abnormalnosti treba razmisliti o prekidu terapije Cimzijom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 10 (5 packs of 2 pre-filled pens and 2 alcohol wipes) (with bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija višestrukog pakiranja od 10 (5 pakiranja od 2 napunjene brizgalice i 2 alkoholne vatice) (s plavim okvirom)
English: This will help to reduce discomfort when injecting.
Croatian: To traje 30-45 minuta, a pomoći će ublažiti nelagodu pri injiciranju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 6 (3 packs of 2 dose-dispenser cartridges and 2 alcohol wipes) (with bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Višestruko pakiranje od 6 (3 pakiranja od 2 napunjene štrcaljke i 2 alkoholne vatice) (s plavim okvirom)
English: Cimzia 400 mg Q2W N=167
Croatian: Cimzia 400 mg svaka dva tjedna N=167
English: What Cimzia looks like and contents of the pack Cimzia is provided as a solution for injection in a ready to use pre-filled syringe.
Croatian: Cimzia dolazi u obliku otopine za injekciju u ulošku za dozator spremnom za uporabu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/006
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Multipack of 6 (3 packs of 2 pre-filled pens and 2 alcohol wipes) (with bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija višestrukog pakiranja od 6 (3 pakiranja od 2 napunjene brizgalice i 2 alkoholne vatice) (s plavim okvirom)
English: Do not use Cimzia after the expiry date which is stated on the pack and pre-filled pen after EXP.
Croatian: Nemojte primijeniti Cimziju nakon isteka roka valjanosti navedenog na pakiranju i napunjenoj brizgalici iza kratice EXP.
English: NAME OF THE MEDICINAL PRODUCT Cimzia 200 mg solution for injection in dose-dispenser cartridge
Croatian: NAZIV LIJEKA Cimzia 200 mg otopina za injekciju u ulošku za dozator
English: Cimzia 200 mg solution for injection in pre-filled syringe certolizumab pegol
Croatian: Cimzia 200 mg otopina za injekciju u napunjenoj brizgalici certolizumabpegol
English: Uncommo vasculitides, lupus erythematosus, drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive
Croatian: Poremećaji krvi i limfnog sustava rijetko pancitopenija, splenomegalija, eritrocitoza, abnormalnosti morfologije bijelih krvnih stanica manje često vaskulitisi, lupus eritematozus, preosjetljivost na lijek (uključujući anafilaktički šok), alergijske reakcije, pozitivna auto-protutijela
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 2 single-use pre-filled syringes 2 alcohol wipes
Croatian: OBLIK I SADRŽAJ Otopina za injekciju u napunjenoj štrcaljki 2 napunjene štrcaljke za jednokratnu uporabu 2 alkoholne vatice
English: Renal and hepatic impairment
Croatian: Bath Ankylosing Spondylitis Disease
English: The dosedispenser cartridge is to be used with the electromechanical injection device ava.
Croatian: Uložak za dozator namijenjen je za uporabu „ava” elektromehaničkim uređajem za injekciju koji se isporučuje zasebno.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One dose-dispenser cartridge contains 200 mg certolizumab pegol in one ml.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan uložak za dozator sadrži 200 mg certolizumabpegola u jednom ml.
English: Sustained remission* (DAS28(ESR) <2.6 at both Week 40 and Week 52) Sustained low disease activity (DAS28(ESR) ≤3.2 at both Week 40 and Week 52) *Primary endpoint of C-EARLY trial (to Week 52) Full analysis set, non-responder imputation for missing values.
Croatian: Održana niska aktivnost bolesti (DAS28(ESR) ≤3,2 u 40. i 52. tjednu)
English: Water for injections
Croatian: Priprema za injiciranje
English: • The starting dose for adults with axial spondyloarthritis is 400 mg given at weeks 0, 2 and 4.
Croatian: • Početna doza za odrasle s aksijalnim spondiloartritisom je 400 mg, a primjenjuje se u 0., 2., i 4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 dose-dispenser cartridges and 2 alcohol wipes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija (za pakiranja od 2 uloška za dozator i 2 alkoholne vatice)
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 6 (for 2 pre-filled pens and 2 alcohol wipes) (without blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU Unutarnja kutija unutar višestrukog pakiranja od 6 (za 2 napunjene štrcaljke i 2 alkoholne vatice) (bez plavog okvira)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/007
English: Cartridge/Injection port
Croatian: Utor za uložak/injekciju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/002
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled pens and 2 alcohol wipes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija (za pakiranja od 2 napunjene brizgalice i 2 alkoholne vatice)
English: Do not use Cimzia after the expiry date which is stated on the pack and dose tray after EXP.
Croatian: Nemojte primijeniti Cimziju nakon isteka roka valjanosti navedenog na pakiranju i ulošku iza kratice EXP.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/001
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU Unutarnja kutija unutar višestrukog pakiranja od 10 (za 2 uloška za dozator i 2 alkoholne vatice) (bez plavog okvira)
English: Do not use this medicine after the expiry date which is stated on the pack and dose-dispenser cartridge after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i brizgalici iza oznake „Rok valjanosti“ ili kratice EXP.
English: Cimzia 400 mg Q2W N=88
Croatian: Cimzia 400 mg svaka dva tjedna N=88
English: Do not use this medicine after the expiry date which is stated on the pack and syringe after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i štrcaljki iza oznake „Rok valjanosti“ ili kratice EXP.
English: Packs of 2 pre-filled syringes and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes are available.
Croatian: Pakiranje od 2 napunjene brizgalice i 2 alkoholne vatice, višestruko pakiranje koje sadrži 6 (3 pakiranja po 2) napunjenih brizgalica i 6 (3 pakiranja po 2) alkoholnih vatica, višestruko pakiranje koje sadrži 10 (5 pakiranja po 2) napunjenih brizgalica i 10 (5 pakiranja po 2) alkoholnih vatica.
English: Cimzia 400 mg Q2W N= 87
Croatian: Cimzia 400 mg svaka dva tjedna N=87
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 pre-filled pens and 2 alcohol wipes) (without bluebox)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SREDNJEM PAKIRANJU Unutarnja kutija unutar višestrukog pakiranja od 10 (za 2 napunjene brizgalice i 2 alkoholne vatice) (bez plavog okvira)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes and 2 alcohol wipes)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija (za pakiranje od 2 napunjene štrcaljke i 2 alkoholne vatice)
English: Each dose-dispenser cartridge contains 200 mg of certolizumab pegol in one ml.
Croatian: Jedan uložak za dozator sadrži 200 mg certolizumabpegola u jednom ml.
English: Cimzia 200 mg solution for injection in dose-dispenser cartridge certolizumab pegol
Croatian: Cimzia 200 mg otopina za injekciju u ulošku za dozator certolizumabpegol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/005
English: Uncommo menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
Croatian: Poremećaji bubrega i mokraćnog sustava rijetko nefropatija (uključujući nefritis) manje često poremećaji menstruacijskog ciklusa i krvarenja iz maternice (uključujući amenoreju), poremećaji dojki
English: • two dose-dispenser cartridges of solution, and
Croatian: • dva otopinom napunjena uloška za dozator i
English: Packs of 2 dose-dispenser cartridges and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) dose-dispenser cartridges and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) dose-dispenser cartridges and 10 (5 packs of 2) alcohol wipes are available.
Croatian: Dostupno je pakiranje od 2 uloška za dozator i 2 alkoholne vatice, višestruko pakiranje koje sadrži 6 (3 pakiranja po 2) uložaka za dozator i 6 (3 pakiranja po 2) alkoholnih vatica te višestruko pakiranje koje sadrži 10 (5 pakiranja po 2) uložaka za dozator i 10 (5 pakiranja po 2) alkoholnih vatica.
English: • Look at the expiry date on the medication and pack.
Croatian: • Provjerite rok valjanosti na ulošku i pakiranju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/009
English: Do not remove the needle cap. - “Medication accepted” is shown if it is correct.
Croatian: - Ako je ispravan, prikazuje se poruka „Uložak prihvaćen“.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/544/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/544/003
English: Cimzia(a)200 mg Q2W
Croatian: Cimzia 200 mg
English: • Inject within 5 minutes of removing the cap. Do not replace the cap. •Although hidden from view the needle tip is now uncovered.
Croatian: • Iako nije izložen pogledu, vršak igle je sada otkriven.
English: You should not do both.
Croatian: Ne smijete raditi i jedno i drugo.
English: How to open the bottle
Croatian: Kako otvoriti bočicu
English: • you have ever had hepatitis B or C
Croatian: • ako ste ikad imali hepatitis B ili C
English: These effects can ease your normal daily activities and so improve your quality of life.
Croatian: Vam olakšati obavljanje uobičajenih svakodnevnih aktivnosti i tako poboljšati kvalitetu života.
English: Table 5: Radiographic changes
Croatian: Tablica 5: Radiografske promjene
English: • The tablets can be taken with or without food.
Croatian: • Tablete možete uzimati s hranom ili bez nje.
English: • Do not take a double dose to make up for a forgotten tablet.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: The most common serious infection was pneumonia.
Croatian: Najčešća ozbiljna infekcija bila je pneumonija.
English: The clinical data are currently limited and long-term studies are ongoing.
Croatian: Klinički su podaci trenutno ograničeni, a dugoročna ispitivanja su u tijeku.
English: Table 4: Response and remission
Croatian: Tablica 4: Odgovor i remisija
English: Each calendar blister contains 7 tablets.
Croatian: Jedan kalendarski blister sadrži 7 tableta.
English: • If you miss a dose, take it as soon as you remember.
Croatian: • Ako propustite uzeti dozu, uzmite je čim se sjetite.
English: All studies included long-term extensions for up to 5 years.
Croatian: Sva su ispitivanja imala dugoročne produžetke u trajanju do 5 godina.
English: Clinical Response:
Croatian: Klinički odgovor:
English: ACR Response
Croatian: ACR odgovor
English: RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the day.
Croatian: RINVOQ se uzima peroralno, jedanput na dan, s hranom ili bez nje, a može se uzeti u bilo koje doba dana.
English: • To help you remember to take RINVOQ, take it at the same time every day.
Croatian: • Da biste se lakše sjetili uzeti RINVOQ, uzimajte ga svaki dan u isto vrijeme.
English: • who have been exposed to tuberculosis
Croatian: • koji su bili izloženi tuberkulozi
English: • you have had tuberculosis or have been in close contact with someone with tuberculosis.
Croatian: • ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s osobom koja ima tuberkulozu.
English: Opportunistic infections (excluding tuberculosis)
Croatian: Oportunističke infekcije (osim tuberkuloze)
English: • Swallow the tablet whole with water.
Croatian: • Tabletu progutajte cijelu, s vodom.
English: • if you have severe liver problems
Croatian: • ako imate teških jetrenih tegoba
English: • if you are allergic to upadacitinib or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na upadacitinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • Morning stiffness
Croatian: • Jutarnja ukočenost
English: • if you have active tuberculosis (TB)
Croatian: • ako imate aktivnu tuberkulozu (TBC)
English: • you have heart problems, high blood pressure, or high cholesterol
Croatian: • ako imate srčanih tegoba, visok krvni tlak ili visoke razine kolesterola
English: The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka RINVOQ u djece i adolescenata u dobi od 0 do manje od 18 godina nisu još ustanovljene.
English: Tablets should be swallowed whole and should not be split, crushed, or chewed.
Croatian: Tablete treba progutati cijele i ne smiju se lomiti, drobiti ni žvakati.
English: The following list of adverse reactions is based on experience from registrational clinical studies.
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz registracijskih kliničkih ispitivanja.
English: Proportion of patients with no radiographic progressiond
Croatian: Udio bolesnika bez radiografske progresijed
English: RINVOQ works by reducing the activity of an enzyme in the body called ‘Janus kinase'.
Croatian: RINVOQ djeluje tako da smanjuje aktivnost jednog enzima u tijelu koji se zove „Janus kinaza”.
English: • who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
Croatian: • koji su živjeli ili putovali u područjima gdje su tuberkuloza ili mikoza endemske bolesti ili
English: Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified.
Croatian: Nuspojave su bile usporedive s onima opaženima pri nižim dozama i nisu utvrđene nikakve specifične toksičnosti.
English: The tablets are provided in blisters or bottles.
Croatian: Tablete dolaze u blisterima ili bočicama.
English: Pregnancy RINVOQ must not be used during pregnancy.
Croatian: Trudnoća RINVOQ se ne smije primjenjivati u trudnoći.
English: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italy
Croatian: S.R. 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italija
English: It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.
Croatian: Pripada skupini lijekova koji se zovu inhibitori Janus kinaze, a pomažu smanjiti upalu.