FrancophonIA/ELRC3.0 huggingface dataset:
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Croatian: Nakon supkutane primjene 40 mg adalimumaba svaki drugi tjedan u odraslih bolesnika s aksijalnim spondiloartritisom bez radiološkog dokaza AS-a, srednja vrijednost (± SD) najniže koncentracije u stanju dinamičke ravnoteže u 68. tjednu iznosila je 8,0 ± 4,6 µg/ml.
English: There is no relevant use of Hefiya in children aged less than 2 years in this indication.
Croatian: Nema relevantne primjene lijeka Hefiya u djece mlađe od 2 godine u ovoj indikaciji.
English: Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Croatian: Adalimumab može u nositelja virusa reaktivirati HBV infekciju.
English: You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).
Croatian: Možete koristiti i donji dio trbuha, ali ne područje 5
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI
English: Hefiya should be used with caution in patients with mild heart failure (NYHA class I/II).
Croatian: . Zato se bolesnicima s blagim zatajenjem srca (NYHA razred I/II) Hefiya mora davati oprezno.
English: Axial spondyloarthritis without radiographic evidence of AS
Croatian: Aksijalni spondiloartritis bez radiografskog dokaza AS-a
English: ≥30% reduction in skin painb
Croatian: smanjenje kožne boli za
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Croatian: Ispitivanjem PsA I u trajanju od 24 tjedna obuhvaćeno je 313 odraslih bolesnika koji nisu ostvarili odgovarajući odgovor na prethodno liječenje nesteroidnim protuupalnim lijekovima.
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Croatian: Liječenje obično nije trebalo prekidati zbog reakcija na mjestu primjene.
English: ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
Croatian: ACR odgovori bolesnika u ispitivanju PsA I bili su slični neovisno o tome jesu li istodobno dobivali metotreksat ili nisu.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta Često
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika u dobi od 4 do 17 godina s poliartikularnim juvenilnim idiopatskim artritisom i u bolesnika u dobi od 6 do 17 godina s artritisom povezanim s entezitisom, povišenje ALT-a ≥ 3 x GGN zabilježeno je u 6,1% bolesnika liječenih adalimumabom i 1,3% bolesnika iz kontrolne skupine.
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Croatian: Zloćudne bolesti nisu primijećene u 60 pedijatrijskih bolesnika s izloženošću od 58,4 bolesnik-godina u ispitivanju adalimumaba provedenom u pedijatrijskih bolesnika s uveitisom.
English: Injection site reaction (including injection site erythema)
Croatian: Vrlo često Reakcije na mjestu primjene (uključujući eritem na mjestu primjene)
English: Figure F: remove the cap
Croatian: Slika F: uklonite zatvarač
English: If you do not respond well enough to these medicines, you will be given Hefiya to reduce the signs and symptoms of your Crohn's disease.
Croatian: Ako na njih ne odgovorite dovoljno dobro, dobit ćete lijek Hefiya kako bi se smanjili simptomi i znakovi Vaše bolesti.
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Croatian: Bolesnici su primili adalimumab u početnoj dozi od 80 mg, a potom po 40 mg svaki drugi tjedan (počevši tjedan dana nakon početne doze) ili placebo tijekom 16 tjedana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF UNIT PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: • There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Croatian: • U bolesnika koji boluju od specifične plućne bolesti koja se naziva kronična opstruktivna plućna bolest (KOPB) i primali su neke druge TNFα blokatore, zabilježeni su i drugačiji oblici raka, osim limfoma.
English: Cartons contain 1 and 2 pre-filled pens of Hefiya.
Croatian: Kutije sadrže 1 ili 2 napunjene štrcaljke lijeka Hefiya.
English: A total of 76.5 % (218 / 285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 % [123 / 178] and 88.8 % [95 / 107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Croatian: Ukupno je 76,5% (218/285) bolesnika kojima je liječenje ponovno uvedeno imalo PGA odgovor “bez bolesti” ili “minimalno” nakon 16 tjedana liječenja, bez obzira jesu li doživjeli relaps u razdoblju kada je liječenje bilo ukinuto
English: Hefiya is administered by injection under the skin (by subcutaneous injection).
Croatian: Hefiya se primjenjuje injekcijom pod kožu (supkutanom injekcijom).
English: EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
Croatian: EU/1/18/1287/006 6 napunjenih brizgalica (3 pakiranja po 2)
English: Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Croatian: Među njima je njih 64 (79,0%), 56 (69,1%), odnosno 43 (53,1%) imalo odgovor ACR 20, ACR 50 odnosno ACR 70.
English: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Croatian: U oba su se klinička ispitivanja upitnikom NEI VFQ-25 određivali ishodi s obzirom na funkcioniranje povezano s vidom koje su prijavljivali bolesnici.
English: • Do not freeze your pen.
Croatian: • Ne zamrzavati brizgalicu.
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg / m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Croatian: Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje tijekom kojeg su bolesnici primali 24 mg/m2 tjelesne površine adalimumaba do maksimalne doze od 40 mg svaki drugi tjedan supkutano tijekom najviše 192 dodatna tjedna.
English: • reproductive tract infections;
Croatian: • infekcije reproduktivnih organa,
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Croatian: • angioedem (lokalizirano oticanje kože), • lihenoidne kožne reakcije (crvenkasto-ljubičasti kožni osip koji svrbi).
English: 10 A-6250 Kundl Austria
Croatian: Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Austrija
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari adipatna kiselina citratna kiselina hidrat natrijev klorid manitol polisorbat 80 kloridna kiselina (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: Hefiya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Croatian: Hefiya je indiciran za liječenje kroničnog neinfektivnog anteriornog uveitisa u djece u dobi od 2 godine i starije u koje nije postignut zadovoljavajući odgovor na konvencionalno liječenje, koji ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno.
English: The recommended Hefiya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (table 3).
Croatian: Preporučena doza lijeka Hefiya za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (tablica 3).
English: • sensation disorders such as tingling, prickling or numbness;
Croatian: • poremećaj osjeta kao što su trnci, bockanje ili utrnulost,
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at Weeks 0 and 2.
Croatian: U ispitivanju CD II, 325 bolesnika koji su izgubili odgovor ili nisu podnosili terapiju infliksimabom randomizirani su u dvije skupine: jedna je primila 160 mg adalimumaba u nultom tjednu i 80 mg adalimumaba dva tjedna kasnije, a druga skupina je primila placebo u nultom tjednu i 2. tjednu.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Croatian: Kod primjene adalimumaba također su prijavljene infekcije sa smrtnim ishodom i po život opasne infekcije (uključujući sepsu, oportunističke infekcije i tuberkulozu), reaktivacija HBV-a i razne zloćudne bolesti (uključujući leukemiju, limfom i hepatosplenični T-stanični limfom).
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Croatian: dvostruko-slijepom ispitivanju s paralelnim skupinama koje je uključivalo 171 dijete (u dobi od 4-17 godina) s poliartikularnim JIA.
English: Hefiya 40 mg solution for injection in pre-filled syringe Hefiya 40 mg solution for injection in pre-filled pen
Croatian: Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki Hefiya 40 mg otopina za injekciju u napunjenoj brizgalici
English: You should record the date when your prefilled syringe is first removed from the refrigerator, and the date after which it should be discarded.
Croatian: Trebate zabilježiti datum kada ste napunjenu štrcaljku prvi put izvadili iz hladnjaka i datum nakon kojeg je trebate baciti.
English: Induction dose
Croatian: Indukcijska doza
English: • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Croatian: • aksijalnog spondiloartritisa bez radiografskog dokaza ankilozantnog spondilitisa
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Croatian: Druge oportunističke infekcije U bolesnika koji primaju adalimumab zabilježene su oportunističke infekcije, uključujući invazivne gljivične infekcije.
English: After 12 weeks of therapy, patients who had received adalimumab in period A were re-randomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Croatian: A primali adalimumab ponovno su randomizirani u razdoblju B u jednu od 3 terapijske skupine (adalimumab u dozi od 40 mg svaki tjedan, adalimumab u dozi od 40 mg svaki drugi tjedan ili placebo od 12. do 35. tjedna).
English: Hefiya is only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Croatian: Hefiya je dostupan samo kao napunjena štrcaljka od 40 mg i napunjena brizgalica od 40 mg.
English: Respiratory, thoracic and mediastinal disorders*
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja*
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Croatian: Ako ta doza ne djeluje dovoljno dobro, Vaš liječnik može povećati doziranje na 40 mg svaki tjedan ili 80 mg svaki drugi tjedan.
English: ASASa 20 week 2 week 12 week 24
Croatian: ASASa 20 2. tjedan 12. tjedan 24. tjedan ASAS 50
English: • do not shake the syringe.
Croatian: • ne protresate brizgalicu.
English: NA
Croatian: Ako
English: Choosing your injection site:
Croatian: Odabir mjesta primjene injekcije:
English: Patients induced with 160 / 80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 9 % respectively, p = 0.019).
Croatian: Bolesnici koji su primili indukciju adalimumabom u dozi od 160/80 mg u osmom su tjednu postigli kliničku remisiju u značajno većem postotku u odnosu na placebo i u ispitivanju UC-I (18%,
English: adalimumab 40 mg weekly N = 70
Croatian: adalimumab 40 mg svaki tjedan N = 70
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 x GGN zabilježena su u 1,8% bolesnika liječenih adalimumabom i 1,8% bolesnika iz kontrolne skupine.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hefiya.
Croatian: Višestruka pakiranja sadrže 6 (3 pakiranja po 2) napunjenih brizgalica lijeka Hefiya.
English: Subcutaneous use.
Croatian: Supkutana primjena.
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Croatian: Djeca i adolescenti u dobi od 6 do 17 godina, tjelesne težine 40 kg ili više
English: The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks.
Croatian: Srednje vrijednosti najniže koncentracije održale su se u bolesnika koji su nastavili primati adalimumab svaki drugi tjedan kroz 52 tjedna.
English: • rheumatoid arthritis,
Croatian: • reumatoidnog artritisa
English: • low blood measurements for phosphate;
Croatian: • niska razina fosfata u krvi,
English: • Sharps disposal container
Croatian: • Spremnik za odlaganje oštrih predmeta
English: Patients who had been randomised to placebo in period A were assigned to receive adalimumab 40 mg every week in period B.
Croatian: A bili randomizirani za primanje placeba je u razdoblju B dodijeljeno liječenje adalimumabom u dozi od 40 mg svaki tjedan.
English: Doses of 20 or 40 mg of adalimumab were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Croatian: Adalimumab u dozi od 20 ili 40 mg primjenjivala se ili svaki drugi tjedan naizmjenično s placebom ili svaki tjedan tijekom 26 tjedana;
English: The recommended dose of Hefiya for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Croatian: aksijalnog spondiloartritisa bez radiografskog dokaza ankilozantnog spondilitisa te u bolesnika sa psorijatičnim artritisom iznosi 40 mg adalimumaba, a primjenjuje se kao pojedinačna doza svaka dva tjedna.
English: No dose-limiting toxicity was observed during clinical trials.
Croatian: U kliničkim ispitivanjima nisu primijećene toksične reakcije koje bi ograničavale dozu.
English: (injection) Clear to slightly opalescent, colourless to slightly yellowish solution.
Croatian: Otopina za injekciju. (injekcija) Bistra do blago opalescentna, bezbojna do blago žućkasta otopina.
English: Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Croatian: 115 45 (39,1) NPc Napomena: neuspjeh liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega (ispitivanje UV II) smatrao se događajem.
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Croatian: Limfomi su se javljali u stopi (interval pouzdanosti 95%) od 0,7 (0,2; 2,7) na 1000 bolesnik- godina u bolesnika liječenih adalimumabom, odnosno u stopi od 0,6 (0,1; 4,5) na 1000 bolesnik- godina u kontrolnoj skupini.
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 radiografskog dokaza ankilozantnog spondilitisa upalne su bolesti kralježnice.
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Hefiya.
Croatian: Sve bolesnike, a posebno one koji u anamnezi imaju dugotrajno korištenje imunosupresivne terapije ili bolesnike s psorijazom i PUVA liječenjem u anamnezi, potrebno je prije i za vrijeme liječenja lijekom
English: • inflammations.
Croatian: • upale.
English: At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Croatian: U četvrtom tjednu bolesnici su randomizirani u skupine koje su primale 40 mg adalimumaba svaki drugi tjedan, 40 mg adalimumaba svaki tjedan ili placebo kroz ukupno razdoblje ispitivanja od 56 tjedana.
English: You should record the date when your prefilled pen is first removed from the refrigerator, and the date after which it should be discarded.
Croatian: Trebate zabilježiti datum kada ste napunjenu brizgalicu prvi put izvadili iz hladnjaka i datum nakon kojeg je trebate baciti.
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 nakon čega 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: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg / ml (without concomitant methotrexate) and 8 to 9 µg / ml (with concomitant methotrexate), respectively.
Croatian: Nakon supkutane primjene adalimumaba u dozi od 40 mg svaka dva tjedna u odraslih bolesnika s reumatoidnim artritisom srednje vrijednosti najniže koncentracije lijeka u stanju dinamičke ravnoteže bile su približno 5 μg /ml (bez istodobne primjene metotreksata), odnosno 8 do 9 μg/ml (uz metotreksat).
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Croatian: U kontroliranim ispitivanjima faze III u kojima se adalimumab primjenjivao u bolesnika s reumatoidnim artritisom i psorijatičnim artritisom, s kontrolnim razdobljem koje je trajalo u rasponu od 4 do 104 tjedna, povišenje razine ALT-a ≥3 x GGN (gornja granica normalnog raspona) zabilježeno je u 3,7% bolesnika liječenih adalimumabom i 1,6% bolesnika iz kontrolne skupine.
English: The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Croatian: Nakon dvostruko slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg adalimumaba supkutano kroz dodatna 144 tjedna.
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab / methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Croatian: U ispitivanju RA V, poboljšanje indeksa onesposobljenosti HAQ i fizičke komponente SF 36 nakon 52 tjedna bilo je veće u bolesnika liječenih kombinacijom adalimumaba i metotreksata (p
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, 160 mg adalimumaba u nultom tjednu i 80 mg nakon 2 tjedna, 80 mg adalimumaba u nultom tjednu i 40 mg nakon 2 tjedna, 40 mg adalimumaba u nultom tjednu i 20 mg nakon 2 tjedna.
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Hefiya.
Croatian: Prije ubrizgavanja lijeka Hefiya morate pročitati, razumjeti i pridržavati se ovih Uputa za uporabu.
English: Hefiya dose for patients with enthesitis-related arthritis Patient weight
Croatian: Tablica 2. Doza lijeka Hefiya za bolesnike s artritisom povezanim s entezitisom
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Croatian: U 79 od 207 bolesnika koji su uzimali adalimumab 40 mg svaki drugi tjedan učinjena je radiografska kontrola nakon 10 godina.
English: Pancreatitis, dysphagia, face oedema
Croatian: Manje često Pankreatitis, disfagija, edem lica
English: Traceability
Croatian: OZNAČIVANJE
English: Preparing the syringe
Croatian: Priprema štrcaljke
English: clinical remission clinical response * p-value for standard dose versus low dose comparison.
Croatian: * p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: Hefiya is used to treat ulcerative colitis in adults.
Croatian: Hefiya je namijenjen liječenju ulceroznog kolitisa u odraslih.
English: Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Croatian: Zatim sljedeću dozu ubrizgajte onog dana kada je to prvotno bilo predviđeno, kao da propusta nije bilo.
English: low dose 20 / 10 mg eow N = 95
Croatian: niska doza 20/10 mg svaki drugi tjedan N = 95
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab.
Croatian: U rijetkim je slučajevima u bolesnika koji su uzimali adalimumab uočen specifičan i težak oblik limfoma.
English: Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Croatian: Tablica 3. Doza lijeka Hefiya za pedijatrijske bolesnike s plak psorijazom
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Croatian: U bolesnika liječenih adalimumabom prijavljeni su štetni događaji u hematološkom sustavu, uključujući medicinski značajne citopenije (npr. trombocitopenija, leukopenija).
English: • double vision;
Croatian: • dvoslike,
English: STATEMENT OF ACTIVE SUBSTANCE
Croatian: NAVOĐENJE DJELATNE TVARI