natgillin/translations-raw huggingface dataset:
Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Izloženost adalimumabu u adolescentnih bolesnika s gnojnim hidradenitisom predviđena je uz pomoć farmakokinetičkog modeliranja i simulacije na temelju farmakokinetike u ostalim indikacijama u drugih pedijatrijskih bolesnika (psorijaza u djece, juvenilni idiopatski artritis, Crohnova bolest u djece i artritis povezan s entezitisom).
The recommended dose of Humira is an initial dose of 20 mg, followed by 20 mg one week later.
Preporučeno doziranje lijeka Humira je početna doza od 20 mg, a zatim 20 mg nakon tjedan dana.
Packs of:
Pakiranja:
After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Nakon sljedeća dva tjedna liječenje se nastavlja dozom od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan, kako je propisao Vaš liječnik.
In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.
Održavanje kliničke remisije ispitivalo se u ispitivanju CD III (CHARM), u kojem su 854 bolesnika otvoreno primila 80 mg lijeka Humira u nultom tjednu i 40 mg dva tjedna kasnije.
Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Bolesnici su bili pogodni za ispitivanje ako je ranije konvencionalno liječenje Crohnove bolesti bilo neuspješno (uključujući kortikosteroid i/ili imunomodulator).
Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age.
Humira je namijenjena liječenju poliartikularnog juvenilnog idiopatskog artritisa u bolesnika u dobi od 2 godine i starijih.
• double vision
• dvoslike
• Ankylosing spondylitis
• ankilozantnog spondilitisa
Of the 424 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 60 subjects were regarded ineligible (e.g. due to deviations or due to complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
60 ispitanika nije zadovoljavalo kriterije (npr. zbog odstupanja ili zbog komplikacija koje su se razvile kao posljedica dijabetičke retinopatije, zbog operacije katarakte ili vitrektomije) i stoga nisu bili uključeni u primarnu analizu djelotvornosti.
Point the white arrow toward the injection site (thigh or abdomen).
Okrenite bijelu strelicu prema mjestu ubrizgavanja (bedro ili trbuh).
Significant improvements at Week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Dermatology Life Quality Index, DLQI) u usporedbi s placebom (ispitivanja I i II) i u usporedbi s MTX-om (ispitivanje II).
Do not touch the area again before injecting.
Prije ubrizgavanja NE dodirujte više to područje.
In Study nr-axSpA I, Humira 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with Humira and 6.5 for those on placebo) who have had an inadequate response to or intolerance to  1 NSAIDs, or a contraindication for NSAIDs.
Ispitivanje nr-axSpA I bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem se tijekom 12 tjedana ispitivalo djelovanje lijeka Humira u dozi od 40 mg svaka dva tjedna u 185 bolesnika s aktivnim nr-axSpA (srednja početna vrijednost aktivnost bolesti [BASDAI] bila je 6,4 u skupini bolesnika koji su primali lijek Humira i 6,5 u skupini koja je primala placebo) koji nisu imali zadovoljavajući odgovor na ≥ 1 NSAIL ili ga nisu podnosili, ili su imali kontraindikaciju za primjenu NSAIL-ova.
• reactivation of hepatitis B
• reaktivacija hepatitisa B
In adult patients with psoriasis, anti-adalimumab antibodies were identified in 77/920 subjects (8.4%) treated with adalimumab monotherapy.
U odraslih bolesnika sa psorijazom protutijela na adalimumab nađena su u 77/920 ispitanika (8,4%) liječenih adalimumabom kao monoterapijom.
At 10 years, 79 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
U 79 od 207 bolesnika koji su prvotno bili liječeni lijekom Humira 40 mg svaki drugi tjedan učinjena je radiološka kontrola nakon 10 godina.
blood lactate dehydrogenase increased
povišena razina laktat dehidrogenaze u krvi
• immune disorders that could affect the lungs, skin and lymph nodes ( most commonly presenting as sarcoidosis);
• imunološki poremećaji koji mogu zahvatiti pluća, kožu i limfne čvorove (najčešće kao sarkoidoza),
• eye infections
• infekcije oka
• Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
• Tuberkuloza se može razviti tijekom terapije čak i ako je Vaše dijete primilo liječenje za prevenciju tuberkuloze.
Do not use Humira
Nemojte primjenjivati lijek Humira
In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
U bolesnika koji nisu istodobno primali metotreksat incidencija protutijela na adalimumab bila je 16/185 (8,6%) u usporedbi s 1/19 (5,3%) bolesnika koji su primali adalimumab uz metotreksat.
Humira may have a minor influence on the ability to drive, cycle or use machines.
Humira može imati manji utjecaj na sposobnost upravljanja vozilima, biciklom i strojevima.
Pull the Grey Cap 1 straight off.
Ravno povucite sivu kapicu (1).
Patients remained on stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and or prednisone ( 0.2 mg /kg/day or 10 mg/day maximum).
Bolesnici su i dalje uzimali stabilne doze nesteroidnih protuupalnih lijekova (NSAIL-ova) i/ili prednizona (≤0,2 mg/kg/dan ili najviše 10 mg/dan).
Do not use the pre-filled syringe if expiry (EXP) date has passed.
Nemojte upotrijebiti napunjenu štrcaljku nakon isteka roka valjanosti (Rok valjanosti, EXP).
• melanoma;
• melanom,
What the Humira pre-filled syringe looks like and contents of the pack
Kako napunjena štrcaljka lijeka Humira izgleda i sadržaj pakiranja
It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy so they can decide when your baby should receive any vaccine.
Važno je da liječnika svoga djeteta i druge zdravstvene radnike obavijestite o tome da ste u trudnoći uzimali lijek Humira kako bi oni mogli odlučiti kada Vaše dijete treba primiti cjepivo.
Ulcerative colitis is an inflammatory disease of the large intestine.
Ulcerozni kolitis je upalna bolest debelog crijeva.
Humira 40 mg weekly N = 70
Humira 40 mg svaki tjedan N = 70
Table 21: Efficacy Results at 12 Weeks, HS Studies I and II HS Study I
Tablica 21: Rezultati djelotvornosti u 12. tjednu, ispitivanja HS I i II Ispitivanje HS
In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
U bolesnika koji nisu istodobno uzimali metotreksat incidencija protutijela na adalimumab bila je 13,5% (24/178 ispitanika), u usporedbi sa 7% (14/198 ispitanika) u bolesnika koji su primali adalimumab uz metotreksat.
P Value
P vrijednost1
Humira may have a small effect on your child's ability to drive, cycle or use machines.
Humira može malo utjecati na djetetovu sposobnost upravljanja vozilima, biciklom i strojevima.
• vasculitis (inflammation of blood vessels)
• vaskulitis (upala krvnih žila)
Humira is used to treat psoriatic arthritis in adults.
Humira je namijenjena liječenju psorijatičnog artritisa u odraslih.
• increased uric acid in the blood
• povećana razina mokraćne kiseline u krvi
The mean (±SD) serum adalimumab trough concentrations achieved at Week 4 were 15.7 ± 6.6 g/ml for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 g/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).
• Enthesitis-related arthritis
• artritisa povezanog s entezitisom
In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
U otvorenom razdoblju ispitivanja, odgovor PASI 75 i PGA rezultat 'bez bolesti' ili 'minimalno'
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• Tuberkuloza se može razviti tijekom terapije čak i ako ste primili liječenje za prevenciju tuberkuloze.
• Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• Vaše dijete treba razmotriti korištenje odgovarajuće kontracepcije kako bi spriječilo trudnoću te bi je trebalo nastaviti koristiti najmanje 5 mjeseci nakon zadnje doze lijeka Humira.
Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection),
infekcije kože i mekog tkiva (uključujući paronihiju, celulitis, impetigo, nekrotizirajući fasciitis i herpes zoster), infekcije uha, infekcije usne šupljine (uključujući herpes simpleks, herpes usne šupljine i infekcije zuba),
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
• Trebate razmotriti korištenje odgovarajuće kontracepcije kako biste spriječili trudnoću te biste je trebali nastaviti koristiti najmanje 5 mjeseci nakon zadnje doze lijeka Humira.
Wipe the injection site in a circular motion with the alcohol pad.
Mjesto na kojem ćete ubrizgati injekciju kružnim pokretima prebrišite jastučićem natopljenim alkoholom.
Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Bolesnici su primili lijek Humira 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.
Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Djelovanje lijeka Humira u dozi od 40 mg svaka dva tjedna ispitivano je u bolesnika s umjereno teškim do teškim aktivnim psorijatičnim artritisom u dva placebom kontrolirana ispitivanja, ispitivanja
Humira 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.
Humira je indicirana 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.
Humira 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 and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Humira je indicirana 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 i liječenje kortikosteroidom i/ili imunomodulatorom, ili u onih koji ne podnose takve vrste terapija ili su im one kontraindicirane.
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
(poliartikularnim juvenilnim idiopatskim artritisom i artritisom povezanim s entezitisom), kao i oni s aksijalnim spondiloartritisom (ankilozantnim spondilitisom i aksijalnim spondiloartritisom bez radiološkog dokaza AS-a), psorijatičnim artritisom, Crohnovom bolešću, ulceroznim kolitisom, psorijazom, gnojnim hidradenitisom i uveitisom.
Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week.
Dva tjedna kasnije (29. dan) liječenje se nastavlja dozom od 40 mg svaki tjedan ili
Patients remained on stable doses of NSAIDs and or prednisone ( 0.2 mg /kg/day or 10 mg/day maximum).
Bolesnici su i dalje uzimali stabilne doze NSAIL-ova i/ili prednizona (≤0,2 mg/kg/dan ili najviše 10 mg/dan).
Humira is administered by injection under the skin (by subcutaneous injection).
Humira se primjenjuje injekcijom pod kožu (supkutanom injekcijom).
Note: P# = Placebo (Number of Events/Number at Risk); A# = HUMIRA (Number of Events/Number at Risk).
Napomena: P# = Placebo (broj događaja/broj bolesnika pod rizikom); A# = HUMIRA (broj događaja/broj bolesnika pod rizikom).
Table 11: Efficacy Results at 12 Weeks, HS Studies I and II
Tablica 11: Rezultati djelotvornosti u 12. tjednu, ispitivanja HS I i II Ispitivanje HS
• benign tumours
• benigni tumori
Table 17: Efficacy Results at 12 Weeks, HS Studies I and II
Tablica 17: Rezultati djelotvornosti u 12. tjednu, ispitivanja HS I i II Ispitivanje HS
In controlled Phase 3 trials of Humira 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 Humira-treated patients and 1.3% of control-treated patients.
U kontroliranim ispitivanjima faze III u kojima se Humira primjenjivala 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 razine ALT-a ≥ 3 x GGN zabilježeno je u 6,1%
If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Ako se za vrijeme terapije ili nakon nje na koži javi nova tvorba ili ako se postojeća tvorba promijeni, javite se svom liječniku.
Needle Cover
Pokrov igle
Humira 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).
Humira je, u kombinaciji s metotreksatom, indicirana 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, DMARD) nije postignut zadovoljavajući odgovor.
The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional 144 weeks.
Nakon dvostruko slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg lijeka Humira supkutano kroz dodatna 144 tjedna.
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.
U četvrtom tjednu bolesnici su randomizirani u skupine koje su primale 40 mg lijeka Humira svaki drugi tjedan, 40 mg lijeka Humira svaki tjedan ili placebo kroz ukupno razdoblje ispitivanja od 56 tjedana.
After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
Nakon odgovarajuće poduke o tehnici injiciranja, bolesnici mogu sami sebi davati injekcije lijeka
Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis.
Tuberkuloza se može razviti tijekom liječenja čak i ako je Vaše dijete primilo preventivnu terapiju za tuberkulozu.
Do not inject in an area where the skin is reddened, bruised, or hard.
Ne ubrizgavajte u dio gdje je koža crvena, postoji modrica ili je tvrda.
• While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand.
• Dok još držite štrcaljku uspravno za dio s označenim volumenima, uklonite nastavak bočice i bočicu tako što ćete odviti nastavak drugom rukom.
Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 1).
Oba su ispitivanja pokazala rani i održan učinak lijeka Humira na stopu neuspjeha liječenja u odnosu na placebo (vidjeti Sliku 1).
• Push plunger to inject solution - it can take from 2 to 5 seconds to empty the syringe
• Potisnite klipni štapić kako biste ubrizgali otopinu lijeka - pražnjenje štrcaljke može potrajati 2
In patients not given concomitant methotrexate, the incidence was 13.6% (3/22), compared to 8.3% (2/24) when adalimumab was used as add-on to methotrexate.
U bolesnika koji nisu istodobno primali metotreksat incidencija je bila 13,6% (3/22), u usporedbi s 8,3% (2/24) u bolesnika koji su primali adalimumab uz metotreksat.
The recommended dose of Humira is an initial dose of 40 mg, followed by 40 mg one week later.
Preporučeno doziranje lijeka Humira je početna doza od 40 mg, a zatim 40 mg nakon tjedan dana.
Humira is administered by subcutaneous injection.
Humira se primjenjuje supkutanom injekcijom.
• liquid is cloudy, discoloured, or has flakes or particles in it
• ako je otopina mutna, obojena, sadrži pahuljice ili čestice
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Odrasli s reumatoidnim artritisom, psorijatičnim artritisom, ankilozantnim spondilitisom ili aksijalnim spondiloartritisom bez radiološkog dokaza AS-a
Table 22:
Tablica 22
• Keep this container out of the sight and reach of children
• Ovaj spremnik čuvajte izvan pogleda i dohvata djece.
• injection site reactions (including pain, swelling, redness or itching)
• reakcije na mjestu ubrizgavanja (uključujući bol, oticanje, crvenilo ili svrbež),
Low Dose 20/10 mg eow N = 95
Niska doza 20/10 mg svaki drugi tjedan N = 95
• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
• Ne pokušavajte si samostalno dati injekciju dok niste sigurni da razumijete kako je pripremiti i ubrizgati.
At 8 years, 81 of 207 patients originally treated with 40 mg Humira every other week were evaluated radiographically.
U 81 od 207 bolesnika koji su prvotno bili liječeni lijekom Humira 40 mg svaki drugi tjedan učinjena je radiološka kontrola nakon 8 godina.
Patients received Humira 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Bolesnici su primali lijek Humira u dozi od 0,8 mg/kg svaki drugi tjedan (do najviše 40 mg), 0,4 mg/kg svaki drugi tjedan (do najviše 20 mg) ili metotreksat u dozi od 0,1 - 0,4 mg/kg jednom tjedno (do najviše 25 mg).
N/A N/A *** p < 0.001 for all comparisons between Humira and placebo * p < 0.05 for all comparisons between Humira and placebo N/A not applicable
*** p < 0,001 za sve usporedbe lijeka Humira s placebom * p < 0,05 za sve usporedbe lijeka Humira s placebom N/P nije primjenjivo
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• kožni vaskulitis (upala krvnih žila u koži)
The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Preporučena doza lijeka Humira za bolesnike s plak psorijazom u dobi od 4 do 17 godina određuje se na temelju tjelesne težine (Tablica 3).
Usually, Humira is used with methotrexate.
Humira se obično primjenjuje u kombinaciji s metotreksatom.
The recommended dose of Humira for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 1).
Preporučena doza lijeka Humira za bolesnike s Crohnovom bolešću u dobi od 6 do 17 godina određuje se na temelju tjelesne težine (Tablica 1).
In controlled trials of Humira (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of Humira-treated patients and 0.6% of control-treated patients.
U kontroliranim ispitivanjima lijeka Humira (početne doze od 160 mg u nultom tjednu i 80 mg u 2. tjednu, a zatim 40 mg svaki tjedan, počevši od 4. tjedna) u bolesnika s gnojnim hidradenitisom, uz kontrolno razdoblje u trajanju od 12 do 16 tjedana, povišenja razine ALT-a ≥ 3 x GGN zabilježena su u 0,3% bolesnika liječenih lijekom Humira i 0,6% bolesnika iz kontrolne skupine.
Each pack contains 1, 2 or 6 pre-filled syringes for patient use with 1, 2 or 6 alcohol pads, respectively.
Jedno pakiranje sadrži 1, 2 ili 6 napunjenih štrcaljki za uporabu od strane bolesnika s 1, 2 odnosno
• signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination
• znakove infekcije kao što su vrućica, mučnina, rane, problemi sa zubima, pečenje pri mokrenju
The blinded period was followed by an open − label period during which patients received Humira 40 mg every other week subcutaneously for up to an additional 28 weeks.
Nakon slijepog dijela ispitivanja slijedio je otvoreni dio ispitivanja u kojem su bolesnici svaki drugi tjedan dobivali 40 mg lijeka Humira supkutano kroz dodatnih 28 tjedana.
Table 8 ACR Responses in RA Study V (percent of patients)
Tablica 8 ACR odgovori u ispitivanju RA V (postotak bolesnika)
Placebo/ MTX n=200
Placebo/ MTXc n=200
Humira 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 Humira group (at Week 48).
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 lijekom Humira 0,0 ± 1,9 (p<0,001) (48. tjedan).
Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Humira je indicirana za liječenje teške kronične plak psorijaze u djece i adolescenata u dobi od 4 godine i starijih u kojih nije postignut zadovoljavajući odgovor ili koji nisu prikladni kandidati za topikalnu terapiju i fototerapije.
The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Limfomi su se javljali uz stopu (interval pouzdanosti od 95%) od 0,7 (0,2; 2,7) na 1000 bolesnik-godina u bolesnika liječenih lijekom Humira, odnosno stopu od 0,6 (0,1; 4,5) na 1000 bolesnik-godina u kontrolnoj skupini.