natgillin/translations-raw huggingface dataset:
Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at Week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Po dajanju 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
CD Study II: Infliximab Experienced Patients
Študija Crohnove bolezni II: bolniki, ki so že prejemali infliksimab
Humira may be available as a vial, a pre-filled syringe and/or a pre-filled pen.
Zdravilo Humira je lahko na voljo tudi kot viala, napolnjena injekcijska brizga in/ali napolnjen injekcijski peresnik.
Table 12 Ped ACR 30 Responses in the JIA study
Preglednica 12 Odzivi »Ped ACR« 30 v študiji pri juvenilnem idiopatskem artritisu
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Za pediatrične bolnike je priporočljivo, da pred začetkom zdravljenja z zdravilom Humira opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
Table 17: Efficacy Results at 12 Weeks, HS Studies I and II
Preglednica 17: Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
Non-serious allergic reactions associated with Humira were uncommon during clinical trials.
Humira povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale občasno.
Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 1).
V obeh študijah je bil dokazan zgodnji in vzdrževan učinek zdravila Humira na odstotek neuspeha zdravljenja proti placebu (glejte sliko 1).
• 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.
• Vaš otrok mora premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Humira.
Humira/MTX n=268
Zdravilo Humira/MTX n = 268
study V was the percent of patients who achieved an ACR 50 response at Week 52.
52. tedna dosegli odziv ACR 50.
• increased uric acid in the blood
• povečana sečna kislina v krvi
Tel.:+36 1 455 8600
MagyarországAbbVie Kft. Tel.:+36 1 455 8600
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 randomized to methotrexate monotherapy, Humira monotherapy and Humira/methotrexate combination therapy, respectively.
V odprtem podaljšanju študije revmatoidnega artritisa V je bila povprečna sprememba celotne Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z zdravilom Humira in kombinacijo zdravila Humira/metotreksat, glede na izhodišče 10,8, 9,2 oz. 3,9.
• injection site reactions (including pain, swelling, redness or itching)
• reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem)
Polyarticular juvenile idiopathic arthritis from 2 years of age
Juvenilni idiopatski artritis Poliartikularni juvenilni idiopatski artritis od 2. leta starosti
ACR 50 Week 12 Week 24
ACR 50 12. teden 24. teden np np
What Humira is and what it is used for What you need to know before your child uses Humira How to use Humira
Kaj je zdravilo Humira in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Humira Kako uporabljati zdravilo Humira
Patients received either placebo or
ki so prejemali placebo.
• musculoskeletal pain
• mišičnoskeletna bolečina
The recommended dose of Humira is an initial dose of 20 mg, followed by 20 mg one week later.
Priporočeni odmerek zdravila Humira je začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
The 1 pre-filled pen pack comes with 2 alcohol pads (1 spare).
Pakiranje z 1 napolnjenim injekcijskim peresnikom ima priložena 2 alkoholna zloženca (1 dodatni).
Serious adverse reactions have been reported for Humira.
Poročali so tudi o resnih neželenih učinkih v zvezi z zdravilom Humira.
Statistically significant increases (improvement) from Baseline to Week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
V obeh skupinah so opazili statistično pomembno povečanje (izboljšanje) indeksa telesne mase in hitrosti rasti od začetka študije do 26. in 52. tedna.
The recommended dose of Humira is an initial dose of 40 mg, followed by 40 mg one week later.
Priporočeni odmerek zdravila Humira je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
Table 16 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Rezultati učinkovitosti po 16, 26 in 52 tednih
Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis
oportunistične okužbe in tuberkuloza (vključno s kokcidioidomikozo, histoplazmozo in kompleksno okužbo z Mycobacterium avium), bakterijske okužbe,
• Do not use the pre-filled syringe if it has been dropped or crushed
• Napolnjene injekcijske brizge ne uporabite, če je padla ali se zdrobila
Humira treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at Week 24.
Ob zdravljenju z zdravilom Humira so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF 36 (Short Form Health Survey).
If you do not respond well enough to these medicines, you will be given Humira to reduce the signs and symptoms of your disease.
Če se nanje ne boste odzvali dovolj dobro, boste dobili zdravilo Humira za zmanjšanje znakov in simptomov vaše bolezni.
Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/ml (79% CV).
Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, so bile povprečne koncentracije adalimumaba v stanju dinamičnega ravnovesja približno 7,4 ± 5,8 µg/ml (79 % KV).
Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Z zdravjem povezano kakovost življenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov
• severe allergic reaction with shock
• huda alergijska reakcija s šokom
If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Če se vašemu otroku med zdravljenjem ali po njem pojavijo nove spremembe na koži, ali če se spremeni videz obstoječih sprememb, morate to povedati zdravniku.
• skin cancer
• kožni rak
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patientyears among control patients.
Med temi kožnimi raki je bil delež (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so dobivali zdravilo Humira, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
Humira 40 mg weekly N = 70
Humira 40 mg vsak teden N = 70
• If you have mild heart failure and you are being treated with Humira, your heart failure status must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in ste zdravljeni z zdravilom Humira, mora vaš zdravnik vaše stanje okvare srca skrbo nadzirati.
40 mg Humira every week
40 mg zdravila Humira vsak teden
• Always keep the pre-filled syringe and the special disposal container out of the sight and reach of children
• Vedno shranjujte napolnjen injekcijski peresnik in poseben zabojnik nedosegljivo otrokom.
Both studies demonstrated an early and sustained effect of Humira on the treatment failure rate versus placebo (see Figure 2).
V obeh študijah je bil dokazan zgodnji in vzdrževan učinek zdravila Humira na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
At Week 16, more patients randomised to Humira 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
V 16. tednu se je več bolnikov, ki so bili randomizirani na zdravilo Humira 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat.
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.
Slepljenemu obdobju je sledilo odprto obdobje, med katerim so bolniki dobivali 40 mg zdravila Humira vsak drugi teden subkutano, do največ dodatnih 28 tednov.
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z zdravilom Humira in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z zdravilom Humira, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
• low blood measurements for red blood cells
• nizke krvne vrednosti za rdeče krvne celice
Throwing away supplies
Kako zavreči ostanke
If you do not respond well enough to these medicines, you will be given Humira to treat your polyarticular juvenile idiopathic arthritis or enthesitisrelated arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom dobili zdravilo Humira.
Clear Liquid in Syringe
Bistra tekočina v brizgi
• methotrexate
Metotreksat
Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441
Place the white needle sleeve straight (90˚ angle) against the injection site.
Bel tulec z iglo položite pokončno (pod kotom 90°) na mesto injiciranja.
• Enthesitis-related arthritis,
• artritis, povezan z entezitisom,
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.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 16/185 (8,6 %), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 1/19
If you forget to give your child a Humira injection, you should inject the Humira dose as soon as you remember.
Če pozabite dati vašemu otroku injekcijo zdravila Humira, mu morate odmerek zdravila Humira injicirati takoj, ko se spomnite.
• Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.
• Ne poskušajte vašemu otroku zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
Do not try to touch the needle housed in the barrel.
Ne poskušajte se dotakniti igle, ki je v brizgi.
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
• sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo, glavobol in izpuščaj)
• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
Humira can slow down the damage to the joints caused by the disease and can help them move more freely.
Zdravilo Humira lahko upočasni napredovanje prizadetosti sklepov, ki jo povzroča bolezen, in jim lahko pomaga, da se bolj prosto gibljejo.
One 0.8 ml vial contains 40 mg adalimumab.
Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
• moderate to severe Crohn's disease in adults and
• zmerne do hude Crohnove bolezni pri odraslih in
Erythema multiforme Stevens-Johnson syndrome angioedema cutaneous vasculitis lichenoid skin reaction
brazgotinjenje redki multiformni eritem1), sindrom Stevens-Johnson1), angioedem1), kožni vaskulitis1) lihenoidna kožna reakcija1)
Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Ankilozirajoči spondilitis (AS) Zdravilo Humira je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in
Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly.
Z drugo roko stisnite kožo na mestu injiciranja, tako da se površina dvigne, in jo držite čvrsto.
The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Priporočeni odmerek zdravila Humira pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
By Week 68, patients receiving continuous Humira treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so neprekinjeno prejemali zdravilo Humira v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
• vasculitis (inflammation of blood vessels)
• vaskulitis (vnetje krvnih žil)
The safety and efficacy of Humira was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Varnost in učinkovitost zdravila Humira so ocenili v dveh študijah (pJIA I in II) pri otrocih z aktivnim poliartikularnim ali poliartikularnim juvenilnim idiopatskim artritisom, z različnimi tipi začetka JIA
• If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy.
• Če ste prejemali zdravilo Humira med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
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.
V kontroliranih preskušanjih z zdravilom Humira (v začetnem odmerku 160 mg, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z zdravilom Humira, in pri 0,6 % bolnikov v kontrolni skupini.
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Psoriatični artritis je vnetje sklepov, povezano s kožno luskavico.
Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Zdravilo Humira je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
The Humira vial is a glass vial containing a solution of adalimumab.
Viala z zdravilom Humira je steklena viala, ki vsebuje raztopino adalimumaba.
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.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
Wipe your skin by using the enclosed alcohol pad, using a circular motion.
S krožnim gibom obrišite kožo s priloženim alkoholnim zložencem.
Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
demielinizacijske bolezni (npr.optični nevritis,
Pull the Grey Cap 1 straight off.
Odstranite siv pokrovček (1).
• 80 mg at Week 0 and 40 mg at Week 2
• 80 mg v 0. tednu in 40 mg v 2. tednu
Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
1p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Mladostniki s hidradenitis suppurativa stari od 12 do 17 let, ki tehtajo 30 kg ali več
All doses/schedules of Humira in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at Week 52.
V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami zdravila Humira izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
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).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil (NSPVZ) in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
• Severe allergic reaction with shock;
• hude alergijske reakcije s šokom;
In the OL LI phase all patients received 24 mg/m up to a maximum of 40 mg Humira every other week for 16 weeks.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) zdravila Humira vsak drugi teden.
The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of Humira up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m2 telesne površine zdravila Humira do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
The patients received 24 mg/m2 body surface area (BSA) of Humira up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Bolniki so vsaj 24 tednov prejemali zdravilo Humira v odmerku 24 mg/m2 telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
• low blood measurements for calcium
• nizke krvne vrednosti za kalcij
Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
The recommended dose of Humira is 40 mg every other week.
Priporočeni odmerek zdravila Humira je 40 mg vsak drugi teden.
• At least 3 cm from your last injection site
• najmanj 3 cm oddaljeno od prejšnjega mesta injiciranja.
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Poliartikularni juvenilni idiopatski artritis je vnetna bolezen sklepov.
Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Zdravilo Humira je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
Humira may have a minor influence on the ability to drive and use machines.
Zdravilo Humira ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
Placebo N=107
Odziv placebo n = 107
Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih revmatoidnega artritisa so zdravilo Humira ocenili pri več kot 3000 bolnikih.
• abnormal blood measurements for sodium
• nenormalne krvne vrednosti za natrij
Humira 40 mg/0.8 ml solution for injection
Humira 40 mg/0,8 ml raztopina za injiciranje
In adult patients with hidradenitis suppurativa, a dose of 160 mg Humira on Week 0 followed by 80 mg on Week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at Week 2 and Week 4.
Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg zdravila Humira na 0. teden, ki mu sledi 80 mg zdravila Humira 2. teden, najnižjo koncentracijo adalimubaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks Placebo N=53 n (%)
Rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.
Zdravilo Humira lahko upočasni napredovanje prizadetosti sklepov, ki jo povzroči vnetna bolezen, in jim lahko pomaga, da se bolj prosto gibljejo.