FrancophonIA/ELRC3.0 huggingface dataset:
English: Impaired renal and/or hepatic function
Croatian: Oštećenje funkcije bubrega i/ili jetre
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with SOLYMBIC.
Croatian: Obavijestite liječnika ako istodobno uz lijek SOLYMBIC uzimate azatioprin ili 6-merkaptopurin.
English: SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn's disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Croatian: SOLYMBIC je namijenjen liječenju reumatoidnog artritisa, artritisa povezanog s entezitisom u djece od 6 do 17 godina, ankilozantnog spondilitisa (AS), aksijalnog spondiloartritisa bez radiološkog dokaza AS-a, psorijatičnog artritisa, psorijaze, gnojnog hidradenitisa (Hidradenitis suppurativa), pedijatrijske psorijaze (bolesnici tjelesne težine ili od 23 do 28 kg ili od 47 kg i više), Crohnove bolesti u odraslih i djece, ulceroznog kolitisa i nezaraznog uveitisa koji zahvaća stražnji dio oka.
English: Paediatric Crohn's disease patients < 40 kg:
Croatian: Crohnova bolest u djece tjelesne težine < 40 kg:
English: Administration of SOLYMBIC is not recommended during pregnancy.
Croatian: Zbog toga se primjena lijeka SOLYMBIC u trudnica ne preporučuje.
English: SOLYMBIC is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Croatian: SOLYMBIC je indiciran za liječenje neinfektivnog intermedijarnog, posteriornog i panuveitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na kortikosteroide, kojima je potrebna poštedna primjena kortikosteroida ili u kojih liječenje kortikosteroidima nije prikladno.
English: After induction treatment, the recommended dose is 20 mg every other week via subcutaneous injection.
Croatian: Nakon indukcije, preporučena doza je 20 mg svaki drugi tjedan supkutanom injekcijom.
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 6).
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 6).
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001
Croatian: Sve p-vrijednosti odnose se na sparene usporedbe udjela uz adalimumab naspram placeba * p < 0,001
English: E. Pull the needle cap straight out and away from your body when you are ready to inject.
Croatian: Povucite zatvarač igle ravno i dalje od Vašeg tijela kada ste spremni za injiciranje.
English: SOLYMBIC is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Croatian: SOLYMBIC je indiciran za liječenje aktivnog i progresivnog psorijatičnog artritisa u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti nije postignut zadovoljavajući odgovor.
English: The results for the 40 mg every other week dose are summarised in table 4.
Croatian: Rezultati zabilježeni u skupini koja je dobivala 40 mg svaka dva tjedna prikazani su u Tablici 4.
English: After two further weeks, continue with a dose of 40 mg every week.
Croatian: Nakon sljedeća dva tjedna liječenje se nastavlja dozom od 40 mg svaki tjedan.
English: Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Croatian: Ledena acetatna kiselina, saharoza, polisorbat 80, natrijev hidroksid i voda za injekciju.
English: Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Croatian: Bath Ankylosing Spondylitis Disease Activity Index)
English: Rare side effects (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count.
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): • niska razina leukocita, eritrocita i trombocita.
English: A. Remove one SOLYMBIC pre-filled pen from the package.
Croatian: Izvadite jednu SOLYMBIC napunjenu brizgalicu iz pakiranja.
English: EU/1/16/1163/002 1 pack EU/1/16/1163/003 2 pack EU/1/16/1163/004 4 pack EU/1/16/1163/005 6 pack
Croatian: EU/1/16/1163/002 1 pakiranje EU/1/16/1163/003 2 pakiranja EU/1/16/1163/004 4 pakiranja EU/1/16/1163/005 6 pakiranja
English: The combination of SOLYMBIC and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirana terapija lijekom SOLYMBIC i abataceptom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: Table 14 Paediatric plaque psoriasis efficacy results at 16 weeks
Croatian: Tablica 14 Rezultati djelotvornosti u pedijatrijskih bolesnika s plak psorijazom u 16. tjednu
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 SOLYMBIC.
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 SOLYMBIC pregledavati u svrhu otkrivanja nemelanomskog karcinoma kože.
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with SOLYMBIC.
Croatian: Bolesnike se mora upozoriti da se obrate liječniku ako se za vrijeme ili nakon liječenja lijekom SOLYMBIC pojave znakovi/simptomi koji upućuju na tuberkuloznu infekciju (npr. perzistirajući kašalj, progresivno propadanje/gubljenje težine, blago povišena tjelesna temperatura, bezvoljnost).
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with SOLYMBIC.
Croatian: Preporučuje se da bolesnik tijekom liječenja lijekom SOLYMBIC svakodnevno koristi topikalnu antiseptičku tekućinu za ispiranje lezija uzrokovanih gnojnim hidradenitisom.
English: SOLYMBIC single use SureClick pre-filled pen For subcutaneous use
Croatian: SOLYMBIC SureClick napunjena brizgalica za jednokratnu primjenu
English: EU/1/16/1163/006 1 pack EU/1/16/1163/007 2 pack EU/1/16/1163/008 4 pack EU/1/16/1163/009 6 pack
Croatian: EU/1/16/1163/006 1 pakiranje EU/1/16/1163/007 2 pakiranja EU/1/16/1163/008 4 pakiranja EU/1/16/1163/009 6 pakiranja
English: SOLYMBIC 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) SOLYMBIC mora davati oprezno.
English: In the open-label extension of RA study V, the mean change from baseline at year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Croatian: U otvorenom produžetku ispitivanja RA V, srednja vrijednost promjene ukupnog zbroja bodova prema modificiranoj Sharpovoj ljestvici od početka ispitivanja do 10. godine iznosila je 10,8 u bolesnika izvorno randomiziranih za monoterapiju metotreksatom, 9,2 u bolesnika izvorno randomiziranih za monoterapiju adalimumabom te 3,9 u bolesnika izvorno randomiziranih za liječenje kombinacijom adalimumaba i metotreksata.
English: Table 9 Efficacy response in placebo-controlled axial SpA study
Croatian: Tablica 9 Djelotvornost u placebom kontroliranom ispitivanju kod aksijalnog spondiloartritisa
English: • Contact details of the prescriber
Croatian: • Kontakt podaci liječnika koji propisuje lijek.
English: The combination of SOLYMBIC and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirana terapija lijekom SOLYMBIC i anakinrom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: 6 pre-filled syringes.
Croatian: 6 napunjenih štrcaljki.
English: SOLYMBIC is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Croatian: SOLYMBIC je indiciran za liječenje umjerenog do teškog oblika aktivnog ulceroznog kolitisa u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno liječenje, uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), ili koji ne podnose ili kod kojih postoje medicinske kontraindikacije za takve terapije.
English: Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Croatian: Djeci koja su u maternici bila izložena adalimumabu ne preporučuje se davati živa cjepiva najmanje 5 mjeseci otkad je majka u trudnoći primila zadnju injekciju adalimumaba.
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se unaprijedila sljedivost bioloških lijekova, zaštićeno ime i broj serije primijenjenog lijeka treba jasno navesti u bolesničkom kartonu.
English: Patients on SOLYMBIC may receive concurrent vaccinations, except for live vaccines.
Croatian: Bolesnici koji primaju lijek SOLYMBIC mogu istodobno primiti cjepiva, ali ne živa cjepiva.
English: In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Croatian: U slučaju monoterapije, u nekih bolesnika u kojih je došlo do slabljenja odgovora na liječenje možda će biti korisno povećati dozu adalimumaba na 40 mg svaki tjedan.
English: Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Croatian: Bolesnici su bili randomizirani i primali su ili 24 mg/m tjelesne površine adalimumaba do maksimalne doze od 40 mg ili placebo svaki drugi tjedan tijekom 12 tjedana.
English: SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Croatian: SOLYMBIC je indiciran za liječenje umjerenog do teškog oblika aktivnog gnojnog hidradenitisa (acne inversa) u odraslih bolesnika u kojih nije postignut zadovoljavajući odgovor na konvencionalno sistemsko liječenje gnojnog hidradenitisa.
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Croatian: U kontroliranim ispitivanjima adalimumaba (početne doze od 80 mg u nultom tjednu, nakon kojih slijede doze od 40 mg svaki drugi tjedan, počevši od 1. tjedna) u bolesnika s uveitisom u trajanju do 80 tjedana, uz medijan izloženosti od 166,5 dana u bolesnika liječenih adalimumabom te 105,0 dana u bolesnika iz kontrolne skupine, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 2,4% bolesnika liječenih adalimumabom i 2,4% bolesnika iz kontrolne skupine.
English: SOLYMBIC is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Croatian: SOLYMBIC je indiciran za liječenje umjerenog do teškog oblika aktivne Crohnove bolesti u pedijatrijskih bolesnika (u dobi od 6 godina i starijih) u kojih nije postignut zadovoljavajući odgovor na konvencionalnu terapiju, uključujući primarnu nutritivnu terapiju, liječenje kortikosteroidom i imunomodulatorom ili u onih koji ne podnose ili u kojih su takve vrste terapija kontraindicirane.
English: Name and address of the manufacturer of the biological active substance Amgen Inc
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: System Organ Class Frequency Adverse Reaction Infections and infestations*
Croatian: Infekcije i infestacije*
English: N = 248 N=248
Croatian: N = 248
English: Allergies (including seasonal allergy) Uncommon Sarcoidosis Vasculitis
Croatian: često preosjetljivost, alergije (uključujući sezonske alergije) manje često sarkoidoza vaskulitis rijetko anafilaksija
English: SOLYMBIC is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Croatian: SOLYMBIC je indiciran za liječenje teškog oblika aksijalnog spondiloartritisa bez radiološkog dokaza AS-a kod odraslih, ali s objektivnim znakovima upale u obliku povišenog C-reaktivnog proteina (CRP) i/ili nalaza magnetne rezonance (MRI), u kojih nije postignut zadovoljavajući odgovor na nesteroidne protuupalne lijekove (NSAIL) ili koji ih ne podnose.
English: SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Croatian: SOLYMBIC je namijenjen liječenju ankilozantnog spondilitisa i aksijalnog spondiloartritisa bez radiološkog dokaza AS-a u odraslih.
English: Adults with hidradenitis suppurativa
Croatian: Odrasli s gnojim hidradenitisom (Hidradenitis suppurativa)
English: Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Croatian: Adalimumab se veže za specifični protein (faktor tumorske nekroze ili TNFα) čije su razine povišene pri upalnim bolestima kao što su reumatoidni artritis, artritis povezan s entezitisom, ankilozantni spondilitis, aksijalni spondiloartritis bez radiološkog dokaza AS-a, psorijatični artritis, psorijaza, gnojni hidradenitis (Hidradenitis suppurativa), Crohnova bolest, ulcerozni kolitis i nezarazni uveitis koji zahvaća stražnji dio oka.
English: How to store SOLYMBIC
Croatian: Kako primjenjivati lijek SOLYMBIC
English: There is no relevant use of adalimumab in children aged below 12 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 12 godina u ovoj indikaciji.
English: System Organ Class Frequency Adverse Reaction Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije često otežano cijeljenje
English: The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for hidradenitis suppurativa.
Croatian: Sigurnost i djelotvornost adalimumaba u liječenju gnojnog hidradenitisa u djece u dobi od 12 do 17 godina nisu još ustanovljene.
English: Your doctor should test you for HBV. SOLYMBIC can cause reactivation of HBV in people who carry this virus.
Croatian: SOLYMBIC može u nositelja virusa uzrokovati reaktivaciju HBV-a.
English: ● Do not remove the needle cap from the syringe until you are ready to inject.
Croatian: Nemojte uklanjati zatvarač igle sa štrcaljke sve dok niste spremni injicirati.
English: Administration of live vaccines to infants exposed to SOLYMBIC in utero is not recommended for 5 months following the mother's last SOLYMBIC injection during pregnancy.
Croatian: Djeci koja su u maternici bila izložena lijeku SOLYMBIC ne preporučuje se davati živa cjepiva najmanje 5 mjeseci otkad je majka u trudnoći primila zadnju injekciju lijeka SOLYMBIC.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with SOLYMBIC.
Croatian: Bolesnike se stoga mora pomno pratiti prije, za vrijeme i nakon završetka liječenja lijekom SOLYMBIC zbog moguće pojave infekcija, uključujući tuberkulozu.
English: SC
Croatian: SN
English: *P < 0.05, ***P < 0.001, adalimumab versus placebo a
Croatian: * P < 0,05, ***P < 0,001, adalimumab naspram placebo a Među svim randomiziranim bolesnicima b
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe EU/1/16/1163/001 - 1 pack
Croatian: SOLYMBIC 20 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1163/001 - 1 pakiranje
English: There is little experience from re-administration after more than 8 weeks since the previous dose.
Croatian: Postoji malo podataka o ponovnoj primjeni lijeka SOLYMBIC kad je prekid terapije trajao duže od 8 tjedana.
English: Enthesitis-related arthritis is an inflammatory disease of the joints.
Croatian: Artritis povezan s entezitisom je upalna bolest zglobova.
English: A patient who requires surgery while on SOLYMBIC should be closely monitored for infections, and appropriate actions should be taken.
Croatian: Bolesnike kojima je za vrijeme liječenja lijekom SOLYMBIC potreban operativni zahvat potrebno je pomno pratiti zbog moguće pojave infekcija i poduzeti odgovarajuće mjere.
English: Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
Croatian: manje često limfom**, novotvorine na solidnim organima (uključujući rak dojke, novotvorine na plućima i štitnjači), melanom**
English: The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex) (see section 4.4).
Croatian: Pokrov igle napunjene štrcaljke napravljen je od suhe prirodne gume (derivat lateksa) (vidjeti dio 4.4).
English: 2-sided P value from log rank test. c NE = not estimable.
Croatian: b Dvostrana P-vrijednost iz log rang testa.
English: Adalimumab b n = 113
Croatian: Adalimum abb n = 113
English: Treatment with SOLYMBIC may result in the formation of autoimmune antibodies.
Croatian: Za vrijeme primjene lijeka SOLYMBIC mogu se razviti autoimuna protutijela.
English: SOLYMBIC is used to treat rheumatoid arthritis in adults.
Croatian: SOLYMBIC je namijenjen liječenju reumatoidnog artritisa u odraslih.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 13).
Croatian: Modified Nail Psoriasis Severity Index, mNAPSI), liječnikovu opću procjenu psorijaze noktiju na rukama (engl.
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe EU/1/16/1163/002 - 1 pack
Croatian: SOLYMBIC 40 mg otopina za injekciju u napunjenoj štrcaljki EU/1/16/1163/002 - 1 pakiranje
English: Packs size of one pre-filled syringe.
Croatian: Pakiranje od jedne napunjene štrcaljke.
English: There is no relevant use of adalimumab in children aged less than 6 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 6 godina u ovoj indikaciji.
English: ● The needle cover of the SOLYMBIC pre-filled syringe is made from dry natural rubber, which contains latex.
Croatian: Pokrov igle SOLYMBIC napunjene brizgalice napravljen je od suhe prirodne gume koja sadrži lateks.
English: Inspect the SOLYMBIC pre-filled syringe.
Croatian: Pregledajte SOLYMBIC napunjenu štrcaljku.
English: A 40 mg pen, and a 20 mg and 40 mg pre-filled syringes are available for patients to administer a full 20 mg or 40 mg dose.
Croatian: Za bolesnike kojima se primijenjuju pune doze od 20 mg ili 40 mg dostupna je brizgalica od 40 mg, i napunjene štrcaljke od 20 mg i 40 mg.
English: A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Croatian: Pojedinačna napunjena štrcaljka lijeka SOLYMBIC može se čuvati na temperaturi najviše do 25°C u razdoblju do 14 dana.
English: Paediatric plaque psoriasis
Croatian: Pedijatrijska doza za psorijazu
English: SOLYMBIC is used to treat hidradenitis suppurativa in adults.
Croatian: SOLYMBIC se koristi za liječenje gnojnog hidradenitisa u odraslih.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphataemia, Dehydration
Croatian: Poremećaji metabolizma i prehrane vrlo često povišena razina lipida često hipokalijemija, povišene razine mokraćne kiseline, abnormalna razina natrija u krvi, hipokalcijemija, hiperglikemija, hipofosfatemija, dehidracija
English: There is no relevant use of adalimumab in children aged less than 4 years in this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 4 godine u ovoj indikaciji.
English: It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy.
Croatian: Ako je moguće, preporučuje se da djeca obave sva cijepljenja prema važećim smjernicama prije započinjanja terapije lijekom SOLYMBIC.
English: Packs sizes of one, two, four and six pre-filled pens.
Croatian: Pakiranja od jedne, dvije, četriri ili šest napunjenih brizgalica.
English: SOLYMBIC 40 mg solution for injection in pre-filled pen 0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I glass).
Croatian: SOLYMBIC 40 mg otopina za injekciju u napunjenoj brizgalici 0,8 ml otopine za injekciju u napunjenoj brizgalici za upotrebu bolesnika koja sadrži napunjenu štrcaljku (staklo tipa I).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), Benign neoplasm
Croatian: često rak kože, isključujući melanom (uključujući bazocelularni karcinom i karcinom skvamoznih stanica),
English: SOLYMBIC 40 mg solution for injection in pre-filled pen EU/1/16/1163/006 - 1 pack
Croatian: SOLYMBIC 40 mg otopina za injekciju u napunjenoj brizgalici EU/1/16/1163/006 - 1 pakiranje
English: SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection.
Croatian: SOLYMBIC 40 mg otopina za injekciju u napunjenoj brizgalici (SureClick) Otopina za injekciju.
English: The recommended SOLYMBIC induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80 mg at week 2.
Croatian: Preporučena indukcijska doza lijeka SOLYMBIC u odraslih bolesnika s umjerenim do teškim ulceroznim kolitisom je 160 mg u nultom tjednu (lijek se može dati kao četiri injekcije u jednom danu ili kao dvije injekcije na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu.
English: On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
Croatian: U rijetkim je slučajevima u nekih bolesnika koji su uzimali adalimumab uočen specifičan i težak oblik limfoma.