FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 3 - Partially open syringe and needle packaging Partially peel open the syringe package from the end closest to the white plunger rod.
Croatian: Korak 3 - Djelomično otvorite pakiranje sa štrcaljkom i iglom
English: The blinded period was followed by an open − label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Croatian: Nakon slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatnih 28 tjedana.
English: • Check the solution in the vial is clear, colourless and has no particles.
Croatian: • Provjerite je li otopina u bočici bistra, bezbojna te da ne sadrži čestice.
English: Adolescents with hidradenitis suppurativa (from 12 to 17 years of age, weighing at least 30 kg)
Croatian: Adolescenti s gnojnim hidradenitisom (u dobi od 12 do 17 godina, tjelesne težine najmanje 30 kg)
English: Table 7: Distribution of patients by age and adalimumab dose received during the OL LI phase
Croatian: Tablica 7: Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Follow the below steps carefully each time you inject Hulio pre-filled syringe:
Croatian: Pažljivo slijedite korake u nastavku pri svakom ubrizgavanju napunjene štrcaljke lijeka Hulio:
English: SPARCCh MRI Sacroiliac Jointsd,i
Croatian: SPARCCh MR sakroilijakalnih zglobovad, i
English: • abdominal (belly) pain;
Croatian: • bol u abdomenu (trbuhu),
English: • irregular heart beat;
Croatian: • nepravilni otkucaji srca,
English: • DO NOT hold the syringe by the plunger rod.
Croatian: • NEMOJTE držati štrcaljku za klip štrcaljke.
English: Gently flip the pink needle cover over the needle and snap into place.
Croatian: Pažljivo podignite ružičasti pokrov preko igle da sjedne na mjesto.
English: • Check the expiry date printed on the pen.
Croatian: • Provjerite rok valjanosti otisnut na bočici.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Croatian: ***, ** Statistički značajno kod p<0,001, odnosno p<0,01, za sve usporedbe adalimumaba s placebom..
English: • cancer of the lymph system (lymphoma);
Croatian: • rak koji zahvaća limfni sustav (limfom),
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Croatian: Natrij Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi od 0,8 ml, tj. zanemarive količine natrija.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg injection adalimumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Hulio 40 mg injekcija adalimumab s.c.
English: A patient who requires surgery while on Hulio should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom Hulio potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: It is important that you tell the baby's doctors and other health care professionals about Hulio use during your child's pregnancy so they can decide when your child's baby should receive any vaccine.
Croatian: Važno je da liječnika svoje kćeri i druge zdravstvene radnike obavijestite o tome da je Vaša kćer tijekom trudnoće primijenjivala lijek Hulio kako bi oni mogli odlučiti kada dijete Vaše kčeri treba primiti cjepivo.
English: adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Croatian: Radiološki nalazi u bolesnika liječenih kombinacijom adalimumaba i metotreksata pokazali su znatno sporiju progresiju strukturnih oštećenja zglobova nego u bolesnika liječenih samo metotreksatom tijekom 6 i 12 mjeseci (vidjeti Tablicu 9).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m² (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s artritisom povezanim s entezitisom u dobi od 6 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene u 24. tjednu) bila je 8,8 ± 6,6 µg/ml za adalimumab bez istodobne primjene metotreksata i 11,8 ± 4,3 µg/ml uz istodobnu primjenu metotreksata.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Croatian: Treatment Satisfaction Questionnaire - medication [TSQM]; ispitivanja HS-I i HS-II) i fizičko zdravlje, koje se određivalo na temelju rezultata za cjelokupnu fizičku komponentu upitnika SF-36 (ispitivanje HS-I).
English: It is important that you tell your baby's doctors and other health care professionals about your Hulio use during your pregnancy so they can decide when your baby should receive any vaccine.
Croatian: Važno je da liječnika svoga djeteta i druge zdravstvene radnike obavijestite o tome da ste u trudnoći uzimali lijek Hulio kako bi oni mogli odlučiti kada Vaše dijete treba primiti cjepivo.
English: Table 23: Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Croatian: Tablica 24: Održavanje kliničke remisije i kliničkog odgovora (postotak bolesnika) Placebo
English: If these medicines do not work well enough, you will be given Hulio.
Croatian: Ako ti lijekovi nisu djelotvorni, bit će Vam propisan lijek Hulio.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your child's doctor immediately.
Croatian: Jave li se tijekom ili nakon liječenja simptomi tuberkuloze (uporan kašalj, gubitak tjelesne težine, bezvoljnost, blaga vrućica) ili neke druge infekcije, javite odmah liječniku svog djeteta.
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa Week 56
Croatian: Bolesnici u remisiji bez primjene steroida ≥ 90 danaa 56. tjedan
English: The recommended dose of Hulio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: U odraslih bolesnika s reumatoidnim artritisom preporučena doza lijeka Hulio iznosi 40 mg adalimumaba, a daje se kao jednokratna doza svaka dva tjedna supkutanom injekcijom.
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 μg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 μg/ml (71.2% CV) with concomitant methotrexate.
Croatian: U bolesnika s poliartikularnim JIA u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i starijih i tjelesne težine manje od 15 kg, nakon primjene 24 mg/m² adalimumaba srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže bila je 6,0 ± 6,1 µg/ml (101% CV) za adalimumab bez istodobne primjene metotreksata i 7,9 ± 5,6 µg/ml (71,2% CV) uz istodobnu primjenu metotreksata.
English: If these medicines do not work well enough, you will be given Hulio to treat your rheumatoid arthritis.
Croatian: Ako ti lijekovi nisu dovoljno djelotvorni, za liječenje reumatoidnog artritisa bit će Vam propisan lijek Hulio.
English: Table 9: Radiographic Mean Changes Over 12 Months in RA Study III
Croatian: Tablica 9: Srednje vrijednosti promjena radioloških nalaza tijekom 12 mjeseci u ispitivanju RA III
English: Vision related effects were not numerically in favour of adalimumab for colour vision in Study UVI and for colour vision, peripheral vision and near vision in Study UV II.
Croatian: Učinci povezani s vidom koji nisu brojčano išli u prilog adalimumabu bili su učinci na vid u boji u ispitivanju UV I, odnosno učinci na vid u boji, periferni vid i vid na blizinu u ispitivanju UV II.
English: Their doctor may recommend temporarily stopping Hulio.
Croatian: Liječnik će možda preporučiti privremeni prestanak uzimanja lijeka Hulio.
English: The usual dose for adults with these conditions is 40 mg adalimumab given every two weeks as a single dose.
Croatian: Uobičajena je doza u odraslih osoba oboljelih od gore navedenih stanja 40 mg adalimumaba koji se primjenjuje kao pojedinačna doza svaki drugi tjedan.
English: Week 104 56.0% 49.3%
Croatian: 104. tjedan 56,0% 49,3% 69,4% 0,002
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Croatian: Radiološki nalazi u bolesnika liječenih kombinacijom adalimumaba i metotreksata pokazali su znatno sporiju progresiju strukturnih oštećenja zglobova nego u bolesnika liječenih samo metotreksatom tijekom 6 i 12 mjeseci (vidjeti Tablicu 11).
English: Hulio is also available as a vial for paediatric use or a pre-filled pen.
Croatian: Hulio je dostupan i u obliku bočice za pedijatrijsku uporabu ili napunjene brizgalice.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p< 0.001) in the adalimumab group (at week 48).
Croatian: Bolesnici koji su primali placebo imali su promjenu mTSS-a u odnosu na početnu vrijednost (srednja vrijednost ± standardno odstupanje) od 0,8 ± 2,5 (24. tjedan), a bolesnici liječeni adalimumabom 0,0 ± 1,9 (p<0,001) (48. tjedan).
English: The recommended dose of Hulio for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Croatian: Preporučena doza lijeka Hulio za bolesnike s artritisom povezanim s entezitisom u dobi od 6 i više godina određuje se na temelju tjelesne težine (Tablica 2).
English: Study nr-axSpA I
Croatian: Ispitivanje nr axSpA I
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in single-use pre-filled syringe with an automatic needle guard.
Croatian: Hulio 40 mg otopina za injekciju u napunjenoj štrcaljki za jednokratnu primjenu s automatskom zaštitom za iglu.
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Croatian: U ispitivanju CD I, 299 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su u jednu od 4 terapijske skupine: placebo u nultom tjednu i nakon 2 tjedna, adalimumab 160 mg u nultom tjednu i 80 mg nakon 2 tjedna, adalimumab 80 mg u nultom tjednu i 40 mg nakon 2 tjedna, adalimumab 40 mg u nultom tjednu i 20 mg nakon 2 tjedna.
English: Step 8 - Pull plunger to draw dose + 0.1 ml Keep the plunger rod pressed down and turn the connected syringe and vial upside down.
Croatian: Korak 8 - Povucite klip za uvlačenje doze + 0,1 ml
English: Follow the steps below carefully each time you inject Hulio pre-filled pen:
Croatian: Pažljivo slijedite korake u nastavku pri svakom ubrizgavanju napunjene brizgalice lijeka Hulio:
English: Table 11: Radiographic Mean Changes Over 12 Months in RA Study III
Croatian: Tablica 11: Srednje vrijednosti promjena radioloških nalaza tijekom 12 mjeseci u ispitivanju RA III
English: Week 52 27.2% 25.9%
Croatian: 52. tjedan 27,2% 25,9% 45,5% < 0,001 < 0,001
English: How to store Hulio
Croatian: Kako čuvati lijek Hulio
English: Hulio Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Croatian: Tablica 2: Doza lijeka Hulio za bolesnike s artritisom povezanim s entezitisom
English: • neck or back pain;
Croatian: • bol u vratu ili leđima,
English: Hulio is also available as a vial for paediatric use or a pre-filled syringe.
Croatian: Hulio je dostupan i u obliku bočice za pedijatrijsku uporabu ili napunjene štrcaljke.
English: Hulio is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Croatian: Hulio je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u odraslih bolesnika u kojih unatoč prethodnom potpunom i odgovarajućem tijeku liječenja kortikosteroidima i/ili imunosupresivima nije postignut odgovor ili kod bolesnika koji ih ne podnose ili im je takva terapija kontraindicirana.
English: Your doctor may prescribe another strength of Hulio if you need a different dose.
Croatian: Ako Vam je potrebna drugačija doza, liječnik Vam može propisati drugu jačinu lijeka Hulio.
English: Standard Dose 40/20 mg eow N = 93
Croatian: Standardna doza 40/20 mg svaki drugi tjedan N=93
English: If these medicines do not work well enough, you will be given Hulio to reduce the signs and symptoms of your disease.
Croatian: Ako ti lijekovi ne budu dovoljno djelotvorni bit će Vam propisan lijek Hulio u svrhu smanjenja znakova i simptoma bolesti.
English: • inflammation of blood vessels;
Croatian: • upala krvnih žila,
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Croatian: Pedijatrijski odgovor ACR 30 (n/N)
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/ml (47.7% CV) with concomitant methotrexate.
Croatian: Nakon primjene 24 mg/m² (do maksimalno 40 mg) supkutano svaki drugi tjedan u bolesnika s poliartikularnim juvenilnim idiopatskim artritisom (JIA) u dobi od 4 do 17 godina, srednja vrijednost najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže (vrijednosti mjerene od 20. do 48. tjedna) bila je 5,6 ± 5,6 µg/ml (102% CV) za adalimumab bez istodobne primjene metotreksata i 10,9 ± 5,2 µg/ml (47,7% CV) uz istodobnu primjenu metotreksata.
English: If you do not respond well enough to these medicines, you will be given Hulio to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ako na njih ne odgovorite dovoljno dobro bit će Vam propisan lijek Hulio kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: 1 sterile vial adapter 2 alcohol pads
Croatian: 1 sterilni nastavak za bočicu 2 jastučića natopljena alkoholom
English: It is recommended that your child uses an antiseptic wash daily on the affected areas.
Croatian: Preporučuje se da dijete svakodnevno ispire zahvaćena područja antiseptičkom tekućinom.
English: Table 10: Radiographic Mean Changes at week 52 in RA Study V
Croatian: Tablica 10: Srednje vrijednosti promjena radioloških nalaza nakon 52 tjedna u ispitivanju RA V
English: p-value
Croatian: P vrijednostb
English: Table 22: Induction of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 22: Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hulio.
Croatian: Za vrijeme liječenja lijekom Hulio može se nastaviti s davanjem glukokortikoida, salicilata, nesteroidnih protuupalnih lijekova ili analgetika.
English: Injection syringe
Croatian: Štrcaljka za injekciju
English: Low Dose 20/10 mg eow N = 95
Croatian: Niska doza 20/10 mg svaki drugi tjedan N=95
English: Hulio 40 mg injection adalimumab Subcutaneous use SC
Croatian: Hulio 40 mg injekcija adalimumab Supkutana primjena s.c.
English: Patients in steroid-free remission for >=90 daysa
Croatian: Bolesnici u remisiji bez primjene steroida ≥ 90 danaa
English: Table 11: Distribution of patients by age and adalimumab dose received during the OL LI
Croatian: Tablica 11: Raspored bolesnika prema dobi i dozi adalimumaba primljenoj u otvorenoj uvodnoj fazi ispitivanja
English: Table 7: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Croatian: Tablica 7: ACR odgovori u ispitivanjima kontroliranim placebom (postotak bolesnika) Odgovor
English: - The other ingredients are monosodium glutumate, sorbitol, methionine, polysorbate 80,
Croatian: - Drugi sastojci su natrijev glutamat, sorbitol, metionin, polisorbat 80, kloridna kiselina i voda za injekcije.
English: In adolescent patients with inadequate response to Hulio 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Croatian: U adolescentnih bolesnika u kojih nije postignut zadovoljavajući odgovor na lijek Hulio u dozi od 40 mg svaki drugi tjedan može se razmotriti povećanje doziranja na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg/0.8 ml injection adalimumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Hulio 40 mg/0,8 ml injekcija adalimumab s.c.
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in pre-filled pen
Croatian: Hulio 40 mg otopina za injekciju u napunjenoj štrcaljki Hulio 40 mg otopina za injekciju u napunjenoj brizgalici
English: 1 box of Hulio vial for paediatric use
Croatian: • 1 kutija bočice lijeka Hulio za pedijatrijsku primjenu
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/ml.
Croatian: U odraslih bolesnika s uveitisom, udarna doza adalimumaba od 80 mg u nultom tjednu i zatim slijedi 40 mg svaki drugi tjedan, počevši od 1. tjedna, dovela je do srednje vrijednosti koncentracija u stanju dinamičke ravnoteže od približno 8 - 10 µg/ml.
English: Hulio Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Croatian: Tablica 3: Doza lijeka Hulio za pedijatrijske bolesnike s plak psorijazom
English: It is important to tell your doctor if your child has had or have a serious heart condition (see “Warnings and precautions”).
Croatian: Ako je Vaše dijete bolovalo, ili boluje, od ozbiljne srčane bolesti, važno je da to kažete liječniku (pogledajte dio „Upozorenja i mjere opreza”).
English: Step 13 - Squeeze injection site
Croatian: Korak 13 - Stisnite mjesto ubrizgavanja
English: In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s plak psorijazom, s kontrolnim razdobljem koje je trajalo u rasponu od 12 do 24 tjedna, povišenja razine ALT-a ≥ 3 × GGN zabilježena su u 1,8% bolesnika liječenih adalimumabom i 1,8% bolesnika iz kontrolne skupine.
English: Table 12: Radiographic Mean Changes at week 52 in RA Study V
Croatian: Tablica 12: Srednje vrijednosti promjena radioloških nalaza nakon 52 tjedna u ispitivanju RA V
English: Step 4 - Uncap pen
Croatian: Korak 4 - Uklonite kapicu brizgalice
English: Rhabdomyolysis, systemic lupus erythematosus
Croatian: manje često rabdomioliza, sistemski lupus eritematosus rijetko sindrom sličan lupusu1)
English: Children or adolescents from 6 to 17 years weighing less than 40 kg:
Croatian: Djeca ili adolescenti u dobi od 6 do 17 godina, tjelesne težine manje od 40 kg:
English: The recommended dose of Hulio is an initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Croatian: Preporučeno doziranje lijeka Hulio je početna doza od 80 mg (dvije injekcije od 40 mg u jednom danu), a zatim 40 mg svaki drugi tjedan, počevši tjedan dana kasnije.
English: Children and adolescents with chronic non-infectious uveitis Children and adolescents from 2 to 17 years of age weighing less than 30 kg: The usual dose of Hulio is 20 mg every other week with methotrexate.
Croatian: Djeca i adolescenti s kroničnim nezaraznim uveitisom Djeca i adolescenti u dobi od 2 do 17 godina, tjelesne težine manje od 30 kg: Uobičajena doza lijeka Hulio je 20 mg svaki drugi tjedan s metotreksatom.
English: Liver failure1)
Croatian: nepoznato zatajenje jetre1)
English: If these medicines do not work well enough, you will be given Hulio to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Croatian: Ako ti lijekovi ne budu dovoljno djelotvorni, za liječenje poliartikularnog juvenilnog idiopatskog artritisa ili artritisa povezanog s entezitisom bit će Vam propisan lijek Hulio.
English: Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Croatian: Nakon 24 tjedna u bolesnika liječenih adalimumabom je u odnosu na bolesnike liječene placebom zabilježeno statistički značajno poboljšanje fizičke funkcije, koja se ocjenjivala uz pomoć upitnika HAQ i kratke zdravstvene ankete SF-36.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ BRIZGALICI
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Croatian: Primjenom udarne doze od 160 mg adalimumaba u nultom tjednu i zatim 80 mg u 2. tjednu postižu se najniže serumske koncentracije adalimumaba od približno 12 µg/ml tijekom razdoblja indukcije.
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Croatian: Među bolesnicima liječenima adalimumabom značajno poboljšanje znakova upale, određeno razinom C-reaktivnog proteina visoke osjetljivosti (hs-CRP) i MR oslikavanjem i sakroilijakalnih zglobova i kralježnice, održalo se do 156. odnosno 104. tjedna.
English: Table 23: Induction of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 23: Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Croatian: Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza AS-a Ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza AS-a upalne su bolesti kralježnice.
English: Your child's doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual recommended dose.
Croatian: Liječnik Vašeg djeteta možda će propisati i početnu dozu od 40 mg, koja se može primijeniti tjedan dana prije početka primjene uobičajene preporučene doze.