natgillin/translations-raw huggingface dataset:
Population pharmacokinetic and pharmacokinetic / pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Populacijskim farmakokinetičkim i farmakokinetičkim/farmakodinamičkim modeliranjem i simulacijom predviđena je usporediva izloženost adalimumabu i djelotvornost adalimumaba u bolesnika liječenih s 80 mg svaki drugi tjedan i u onih liječenih s 40 mg svaki tjedan (uključujući odrasle bolesnike s reumatoidnim artritisom, gnojnim hidradenitisom, ulceroznim kolitisom,
RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti-rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Ispitivanje RA I obuhvatilo je 271 bolesnika s umjereno teškim do teškim aktivnim reumatoidnim artritisom u dobi od 18 godina i starijih u kojih prethodna terapija barem jednim antireumatskim lijekom koji modificira tijek bolesti nije bila uspješna, u kojih nije bio dovoljno djelotvoran metotreksat u dozi od 12,5 do 25 mg (10 mg ako bolesnik ne podnosi metotreksat) jednom tjedno i u kojih je doza metotreksata bila konstantno 10 do 25 mg jednom tjedno.
Psoriasis Study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
U ispitivanju Psoriasis Study III (REACH) uspoređivale su se djelotvornost i sigurnost adalimumaba u odnosu na placebo u 72 bolesnika s umjerenom do teškom kroničnom plak psorijazom i psorijazom šaka i/ili stopala.
Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Nisu dostupni odgovarajući podaci o kombiniranom liječenju antivirusnom terapijom i antagonistom TNF-a u svrhu prevencije reaktivacije HBV-a u bolesnika koji su nositelji HBV-a.
• shortness of breath;
• nedostatak zraka,
SPARCCh MRI sacroiliac jointsd,i SPARCC MRI spined,j a assessment of SpondyloArthritis International Society b
SPARCCh MR sakroilijakalnih zglobovad,i SPARCC MR kralježniced,j a međunarodno društvo za ocjenu spondiloartritisa (engl.
Upon completion of the first 52 weeks, 457 patients enrolled in an openlabel extension phase in which 40 mg of adalimumab / MTX was administered every other week up to 10 years.
Po završetku prva 52 tjedna, 457 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem su se adalimumab u dozi od 40 mg/MTX primjenjivali svaka dva tjedna do 10 godina.
Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively.
Veza između izloženosti i odgovora na liječenje, odnosno između koncentracije adalimumaba i njegove djelotvornosti u pedijatrijskih bolesnika s teškom kroničnom plak psorijazom utvrđena je za odgovor PASI 75 i PGA rezultat 'bez bolesti' ili 'minimalno'.
Contact your pharmacist if the pen fails any of the above mentioned checks.
Obratite se ljekarniku ako brizgalica ne prođe navedene provjere.
The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥ 40 kg (160 / 80 mg) and 10.6 ± 6.1 µg / ml for patients < 40 kg (80 / 40 mg).
Srednje vrijednosti (±SD) najnižih koncentracija adalimumaba u serumu u 4. tjednu bile su 15,7 ± 6,6 µg/ml u bolesnika tjelesne težine ≥ 40 kg (160/80 mg) i 10,6 ± 6,1 µg/ml u bolesnika tjelesne težine < 40 kg (80/40 mg).
One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Paediatric CD Study) nastavilo je otvoreni dugotrajni produžetak ispitivanja.
• 80 mg at week 0 and 40 mg at week 2 ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
• 80 mg u nultom tjednu i 40 mg u drugom tjednu ≥ 40 kg • 80 mg u nultom tjednu i 40 mg u drugom tjednu
Polyarticular juvenile idiopathic arthritis (pJIA)
Poliartikularni juvenilni idiopatski artritis (pJIA)
If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
40 mg svaki tjedan ili 80 mg svaki drugi tjedan postigne zadovoljavajući odgovor, doziranje se potom može smanjiti na 40 mg svaki drugi tjedan.
week 8 and 52 sustained response sustained remission sustained mucosal healing clinical remission is Mayo score ≤ 2 with no subscore > 1; clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30 % plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions ** p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a of those receiving corticosteroids at baseline
klinički odgovor je postignut ako je ostvareno smanjenje Mayo rezultata u odnosu na početne vrijednosti od ≥ 3 boda i ≥ 30%, uz smanjenje podrezultata rektalnog krvarenja [engl. rectal bleeding subscore, RBS] od ≥1 ili apsolutni RBS od 0 ili 1; * p<0,05 za adalimumab naspram placeba, sparena usporedba udjela ** p<0,001 za adalimumab naspram placeba, sparena usporedba udjela a onih koji su na početku uzimali kortikosteroide
Consequently, Hefiya can be used during breastfeeding..
Stoga se Hefiya može primjenjivati tijekom dojenja.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine / 6-mercaptopurine compared with adalimumab alone.
U ispitivanjima kod Crohnove bolesti u odraslih, kod kombinacije adalimumaba i azatioprina/6-merkaptopurina primijećene su veće incidencije nuspojava povezanih sa zloćudnim bolestima i ozbiljnim infekcijama nego kod primjene samo adalimumaba.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Nakon završetka oba ispitivanja, 383 bolesnika uključeno je u otvoreni produžetak ispitivanja u kojem su dobivali 40 mg adalimumaba svaki drugi tjedan.
• Dispose of the used syringe in a sharps container (closable, puncture-resistant container).
• Zbrinite iskorištene brizgalice u spremnik za oštre predmete (spremnik koji se može zatvoriti i otporan je na bušenje).
It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Ako ste bolovali ili bolujete od ozbiljne srčane bolesti, važno je da to kažete liječniku (pogledajte dio “Upozorenja i mjere opreza“).
Lupus-like syndrome1)
Sindrom sličan lupusu1)
Full instructions for use are provided in the package leaflet.
Cjelovite upute za uporabu nalaze se u uputi o lijeku..
Patients who had been randomised to placebo in period A were assigned to receive placebo in period B.
A bili randomizirani za primanje placeba nastavili su primati placebo i u razdoblju B.
Table 14 efficacy response in placebo-controlled study nr-axSpA I
Tablica 14 Djelotvornost u placebom kontroliranom ispitivanju nr-axSpA I
Hefiya 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 corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Hefiya 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.
The combination of adalimumab and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinirana terapija adalimumabom i anakinrom se ne preporučuje (vidjeti dio 4.4 “Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
RA Study Ia**
Ispitivanje RA Ia**
Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose
Početna doza od 40 mg, a zatim 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze
Crohn's disease
Crohnova bolest
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.452.73) with RA and CD combined.
Prilagođen OR (kod kojega su uzete u obzir početne razlike) iznosio je 1,10 (95% CI: 0,45 - 2,73) za reumatoidni artritis i Crohnovu bolest zajedno.
RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
ND 4,5% 23,2% a Ispitivanje RA I nakon 24 tjedna, ispitivanje RA II nakon 26 tjedana, ispitivanje RA III
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
I uočeno je i značajno poboljšanje rezultata za cjelokupnu fizičku i mentalnu komponentu iz upitnika SF-36 u usporedbi s placebom.
Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Neuspjeh liječenja definirao se višekomponentnim ishodom koji se temeljio na upalnim korioretinalnim i/ili upalnim retinalnim vaskularnim lezijama, stupnju prema broju stanica u prednjoj očnoj komori (engl. anterior chamber [AC] cell grade), stupnju prema zamućenju staklovine (engl.
Juvenile idiopathic arthritis
Juvenilni idiopatski artritis
Study nr-axSpA I
Ispitivanje nr-axSpA I
• 160 mg at week 0 and 80 mg at week 2
• 160 mg u nultom tjednu i 80 mg u drugom tjednu
• signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
• znakove i simptome infekcije kao što su vrućica, mučnina, rane, problemi sa zubima, pečenje pri mokrenju, osjećaj slabosti ili umora ili kašalj
• gallbladder inflammation, gallbladder stones;
• upala žučnog mjehura, žučni kamenci,
Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Hefiya je, u kombinaciji s metotreksatom, indiciran za liječenje aktivnog poliartikularnog juvenilnog idiopatskog artritisa u bolesnika u dobi od 2 godine i starijih u kojih prethodnim liječenjem jednim ili više antireumatika koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drug,
b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
a p-vrijednost dobivena sparenom usporedbom monoterapije metotreksatom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa b p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i kombinirane terapije adalimumabom i metotreksatom uz primjenu Mann-Whitney U testa c p-vrijednost dobivena sparenom usporedbom monoterapije adalimumabom i monoterapije metotreksatom uz primjenu Mann-Whitney U test
5 How to store Hefiya Contents of the pack and other information Instructions for use
Sadržaj pakiranja i druge informacije Upute za uporabu
• heart attack;
• srčani udar,
* Note: Hefiya is currently only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
*Napomena: Hefiya je trenutačno dostupan samo kao napunjena štrcaljka od 40 mg i kao napunjena brizgalica od 40 mg
Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
U kliničkim ispitivanjima istodobne primjene anakinre i drugog antagonista TNF-a, etanercepta, zabilježene su ozbiljne infekcije, a pritom nije bilo dodatne kliničke koristi u odnosu na monoterapiju etanerceptom.
Table 27 paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission standard dose 40 / 20 mg eow low dose 20 / 10 mg eow p value1
Tablica 27 Ispitivanje kod Crohnove bolesti u djece Prestanak uzimanja kortikosteroida ili imunomodulatora i remisija fistula standardna doza 40/20 mg svaki drugi tjedan niska doza 20/10 mg svaki drugi tjedan p vrijednost1
Figure F: clean your injection site
Slika F: očistite mjesto primjene injekcije
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Najniže koncentracije adalimumaba u serumu u stanju dinamičke ravnoteže povećavale su se uglavnom razmjerno dozi nakon supkutane primjene 20, 40 i 80 mg svaka dva tjedna, odnosno svakog tjedna.
Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Ispitanicima kod kojih je došlo do egzacerbacije tijekom dvostruko slijepog razdoblja bilo je dopušteno primati spasonosnu terapiju adalimumabom u dozi od 40 mg svaka dva tjedna tijekom najmanje 12 tjedana.
These results suggest that some patients who have not responded by Week 4 benefit from continued maintenance therapy through Week 12.
To pokazuje da neki bolesnici koji u 4. tjednu nisu imali klinički odgovor mogu imati koristi ako se terapija nastavi do 12. tjedna.
• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• liječenje umjereno teškog do teškog oblika reumatoidnog artritisa u aktivnoj fazi u odraslih bolesnika u kojih prethodnim liječenjem antireumaticima koji modificiraju tijek bolesti, uključujući metotreksat, nije postignut zadovoljavajući odgovor.
Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Sigurnost preporučene doze adalimumaba u adolescentnoj populaciji s gnojnim hidradenitisom temelji se na sigurnosnom profilu adalimumaba u drugim indikacijama i u odraslih i u pedijatrijskih bolesnika pri sličnoj ili većoj učestalosti doziranja
ACR 20 week 52 62.6 % 54.4 % 72.8 % 0.013 < 0.001 0.043 week 104 56.0 % 49.3 % 69.4 % 0.002 < 0.001 0.140 ACR 50 week 52 45.9 % 41.2 % 61.6 % < 0.001 < 0.001 0.317 week 104 42.8 % 36.9 % 59.0 % < 0.001 < 0.001 0.162 ACR 70 week 52 27.2 % 25.9 % 45.5 % < 0.001 < 0.001 0.656 week 104 28.4 % 28.1 % 46.6 % < 0.001 < 0.001 0.864
52 tjedna 62,6% 54,4% 72,8% 0,013 104 tjedna 56,0% 49,3% 69,4% 0,002 ACR 50
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 19).
Modified Nail Psoriasis Severity Index, mNAPSI), liječnikovu opću procjenu psorijaze noktiju na rukama (engl.
The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2-< 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Sigurnost i djelotvornost primjene adalimumaba ocijenjena je u otvorenom, multicentričnom ispitivanju koje je uključivalo 32 djece (u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i više i tjelesne težine manje od 15 kg) s umjerenim do teškim aktivnim poliartikularnim JIA.
MTX n = 257 confidence interval)
MTX n=257 (95% interval pouzdanosti)
In RA study III, where adalimumab-treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
U ispitivanju RA III, u kojem je srednje trajanje reumatoidnog artritisa u bolesnika liječenih adalimumabom bilo 11 godina, strukturno oštećenje zglobova procjenjivalo se radiografski, a izraženo je promjenom ukupnog zbroja bodova prema modificiranoj Sharpovoj ljestvici (engl.
Serious adverse reactions have been reported for adalimumab.
Uz adalimumab prijavljene su ozbiljne nuspojave.
Hefiya is available as a pre-filled syringe and a pre-filled pen (SensoReady).
Hefiya može biti dostupan u obliku napunjene štrcaljke i napunjene brizgalice (SensoReady).
- If you have any further questions, please ask your doctor or pharmacist.
Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
Antibiotics may be continued during treatment with Hefiya, if necessary.
Ako je potrebno, primjena antibiotika može se nastaviti i tijekom liječenja lijekom Hefiya.
Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Manje često Aneurizma aorte, okluzije arterijskih žila, tromboflebitis
• dehydration;
• dehidracija,
Table 26 paediatric CD study PCDAI clinical remission and response standard dose 40 / 20 mg eow N = 93
PCDAI klinička remisija i odgovor standardna doza 40/20 mg svaki drugi tjedan N = 93
Completing your injection:
Završetak injekcije:
• If you are about to have surgery or dental procedures tell your doctor that you are taking Hefiya.
Kirurški ili stomatološki zahvati • Ako se spremate podvrgnuti kakvom kirurškom ili stomatološkom zahvatu, molimo da svog liječnika obavijestite o tome da primjenjujete lijek Hefiya.
Disposing of used pens:
Zbrinjavanje korištenih brizgalica:
Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Vrlo često Infekcije dišnih putova (uključujući infekcije donjih i gornjih dišnih putova, pneumoniju, sinusitis, faringitis, nazofaringitis i pneumoniju uzrokovanu virusom herpesa)
It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Pritom liječnici koji propisuju lijek trebaju imati na umu da tuberkulinski kožni test može dati lažno negativne rezultate, pogotovo u teško bolesnih ili imunokompromitiranih bolesnika.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for controltreated patients.
U dvostruko slijepim, kontroliranim dijelovima pivotalnih ispitivanja, liječenje je zbog štetnih događaja prekinuto u 5,9% bolesnika koji su dobivali adalimumab, odnosno 5,4% bolesnika iz kontrolne skupine.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Djeca, adolescenti i odrasli s poliartikularnim juvenilnim idiopatskim artritisom Djeca, adolescenti i odrasli u dobi od 2 i više godina, tjelesne težine 30 kg ili više Preporučena doza lijeka Hefiya je 40 mg svaki drugi tjedan.
• inflammation of the eye lid and eye swelling;
• upala očnog kapka i oticanje oka,
Statistically significant increases (improvement) from Baseline to week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
U obje skupine su zabilježena statistički značajna povećanja (poboljšanja) indeksa tjelesne mase i brzine rasta u 26. i 52. tjednu u odnosu na početne vrijednosti.
Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Hefiya 40 mg otopina za injekciju u napunjenoj štrcaljki za jednokratnu primjenu Hefiya se isporučuje u prozirnoj napunjenoj štrcaljki za jednokratnu primjenu (staklo tipa I), s gumenim čepom i iglom od nehrđajućeg čelika s automatskim štitnikom za iglu s hvatištem za prste, gumenim zatvaračem igle i plastičnim klipom, a koja sadrži 0,8 ml otopine.
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Prijavljeni su i rijetki slučajevi hepatospleničnog T-staničnog limfoma u bolesnika liječenih adalimumabom nakon stavljanja lijeka u promet (vidjeti dio 4.4).
The patients received 24 mg / m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Bolesnici su primali 24 mg/m2 tjelesne površine adalimumaba, do maksimalne doze od 20 mg, svaki drugi tjedan kao pojedinačnu dozu s.c. injekcijom kroz najmanje 24 tjedna.
week 4 clinical remission clinical response (CR
4. tjedan klinička remisija klinički odgovor (CR-100)
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
uzrokovane bakterijama, mikobakterijama, invazivnim gljivicama, parazitima, virusima, ili druge oportunističke infekcije poput listerioze, legioneloze i pneumocistisa.
• shortness of breath with exertion or upon lying down or swelling of the feet.
• otežano disanje, gutanje, • nedostatak zraka u naporu ili nakon lijeganja ili oticanje stopala.
Your Hefiya single-use pre-filled syringe with needle guard and add-on finger flange
Vaša jednokratna napunjena štrcaljka lijeka Hefiya sa štitnikom igle i dodatnim hvatištem za prste
40 mg adalimumab every week week 26
40 mg adalimumaba svaki tjedan
Crohn's disease is an inflammatory disease of the gut.
Crohnova bolest je upalna bolest crijeva.
• Keep the syringes in the original carton until ready to use to protect from light.
• Štrcaljke čuvati u originalnoj kutiji dok niste spremni za primjenu radi zaštite od svjetlosti.
*** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
*** p < 0,001 za sve usporedbe adalimumaba s placebom * p < 0,05 za sve usporedbe adalimumaba s placebom N/P nije primjenjivo
• pulmonary embolism (blockage in an artery of the lung);
• plućna embolija (blokada u plućnoj arteriji),
Psoriatic arthritis
Psorijatični artritis
• symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
• simptomi problema sa živcima kao što su trnci, utrnulost, dvoslike ili slabost u rukama ili nogama,
Sodium content
Sadržaj natrija
It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Važno je da liječnika obavijestite ako razvijete simptome infekcije, kao što su vrućica, rane, osjećaj umora i problemi sa zubima.
Hypertension, flushing, haematoma
Hipertenzija, navale crvenila, hematomi
Ulcerative colitis
Ulcerozni kolitis
• ulcerative colitis and
• ulceroznog kolitisa i
Ulcerative colitis is an inflammatory disease of the bowel.
Ulcerozni kolitis je upalna bolest crijeva.
System Organ Class
Organski sustav
Results from the Short Form Health Survey (SF 36) for all doses / schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Short Form Health Survey, SF 36) podupiru te nalaze za sve doze/režime davanja adalimumaba u sva četiri ispitivanja, sa statistički značajnim rezultatom za cjelokupnu fizičku komponentu (engl.