natgillin/translations-raw huggingface dataset:
RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Študija revmatoidnega artritisa V je ocenila 799 odraslih bolnikov, ki še niso dobivali metotreksata in so imeli zmerno do hudo aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
Humira has not been studied in patients aged less than 2 years.
Študije z zdravilom Humira pri bolnikih mlajših od 2 let niso bile izvedene.
At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
• Cases of non-melanoma skin cancer have been observed in patients taking Humira.
• Pri bolnikih, zdravljenih z zdravilom Humira, so opazili primere nemelanomskega kožnega raka.
Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/ml (47.7% CV) with concomitant methotrexate.
Po uporabi 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
Table 8 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritisfrom 2 years of age is based on body weight (Table 1).
Priporočeni odmerek zdravila Humira pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik predpiše začetni odmerek 80 mg, ki mu sledi 40 mg dva tedna kasneje.
ACR 20 Week 12 Week 24
ACR 20 12. teden 24. teden np np
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.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13,6 % (3/22) bolnikov, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 8,3 % (2/24) bolnikov.
• elevated liver enzymes.
• zvišani jetrni encimi.
The safety and efficacy of Humira were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised doubleblind study (Psoriasis Study III).
Varnost in učinkovitost zdravila Humira so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
White Needle Sleeve
Bel tulec igle
ACR 70 Week 12 Week 24
ACR 70 12. teden 24. teden np np
In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.
V kontroliranih preskušanjih z zdravilom Humira (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z zdravilom Humira in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z zdravilom Humira in pri 2,4 % bolnikov v kontrolni skupini.
In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Humira in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Humira, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
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 Humira.
Pri bolnikih, ki so dobivali zdravilo Humira, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioza, legioneloza in pnevmocistična okužba.
Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
40 bolnikov ni pokazalo napredovanja strukturne prizadetosti izražene s spremembo srednje Sharpove ocene 0,5 ali manj od začetka študije.
At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 17).
Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints.
Revmatoidni artritis Revmatoidni artritis je vnetna bolezen sklepov.
At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 11).
V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 11).
• sensation of heart beating irregularly such as skipped beats
• občutek neenakomernega bitja srca kot je preskakovanje utripov
Total Sharp Score Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
ACR 50 52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104. teden 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162 ACR 70 52. teden 27,2 % 25,9 % 45,5 % < 0,001 < 0,001 0,656 104. teden 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z zdravilom Humira/metotreksat z Mann-Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije z zdravilom Humira in kombinirane terapije z zdravilom Humira/metotreksat z Mann-Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije z zdravilom Humira in monoterapije z metotreksat z Mann-Whitneyevim testom U.
Contains 2 cartons each for a single injection only Each carton contains:
raztopina za injiciranje Vsebuje 2 škatli, vsaka škatla je namenjena enkratnemu injiciranju.
Humira was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Zdravilo Humira je bilo ocenjeno v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti indukcijskega in vzdrževalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
• There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.
• Med bolniki (otroci in odraslimi), ki so jemali zdravilo Humira ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
Humira showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to Week 12 compared to placebo.
HAQ-S vprašalniku in točk v telesni komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
If you do not respond well enough to these medicines, you will be given Humira.
Če se na ta zdravila ne odzovete dovolj dobro, boste dobili zdravilo Humira.
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration
Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokalemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalcemija, hiperglikemija, hipofosfatemija, dehidracija
Of 342 subjects originally randomized to Humira monotherapy or Humira/methotrexate combination therapy who entered the openlabel extension study, 171 subjects completed 10 years of Humira treatment.
Humira/metotreksat in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10
• elevated liver enzymes
• zvišani jetrni encimi
Humira 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 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Humira je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate zdravilo
• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
• Ne poskušajte si zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Ne poskušajte si zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
• swollen face, hands, feet
• oteklost obraza, dlani in stopal
Humira is used to treat psoriatic arthritis in adults.
Zdravilo Humira se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis,
The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection.
Priporočeni odmerek zdravila Humira je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
• After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
• Po injiciranju zdravila Humira takoj zavrzite odrabljeni napolnjeni injekcijski peresnik v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
Depending on your child's response, your child's doctor may increase the dose frequency to 20 mg every week.
Glede na odziv vašega otroka mu lahko njegov zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
If it is cloudy or discoloured or has flakes or particles in it, you must not use it. Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight.
Če je motna, obarvana ali vsebuje kosme ali delce, je ne smete uporabiti.
Cap 1
Preglednica 1.
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če vaš otrok dobi kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Humira.
V redkih primerih so pri bolnikih, ki dobivajo zdravilo Humira, opazili specifično in resno obliko limfoma.
• If your child takes Humira the risk of getting lymphoma, leukaemia, or other cancers may increase.
• Če vaš otrok uporablja zdravilo Humira, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Humira is used to treat rheumatoid arthritis in adults.
Zdravilo Humira se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Preglednica 13: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
• cutaneous vasculitis (inflammation of blood vessels in the skin)
• kožni vaskulitis (vnetje krvnih žil v koži)
Humira is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Zdravilo Humira se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih,
• 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.
Medtem brizgo še vedno držite na delu z merilom in pokonci, odstranite adapter za vialo in vialo tako, da z drugo roko adapter za vialo zasučete z brizge.
There is limited safety experience of surgical procedures in patients treated with Humira.
Operacije Izkušnje z varnostjo operacij pri bolnikih, zdravljenih z zdravilom Humira, so omejene.
Your doctor may increase the dose frequency to 20 mg every week.
Vaš zdravnik lahko poveča pogostnost odmerjanja na 20 mg vsak teden.
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z zdravilom Humira pri pediatričnih bolnikih s psoriazo v plakih.
What the Humira pre-filled syringe with automatic needle guard looks like and contents of the pack
Izgled zdravila Humira napolnjena injekcijska brizga z avtomatskim ščitnikom za iglo in vsebina pakiranja
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Priporočljivo je, da se vsako leto ocenijo koristi in tveganja nadaljnega dolgotrajnega zdravljenja (glejte poglavje 5.1).
• pulmonary embolism (bloackage in an artery of the lung);
• pljučni embolizem (zamašitev arterije v pljučih);
Week 12 Week 24 ASAS 70 Week 2
ASASa 20 2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
When Humira therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 7).
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili radiografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 7).
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile;
Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Zdravilo Humira 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
Hold the grey body of the pre-filled pen with one hand.
Z eno roko primite sivo telo napolnjenega injekcijskega peresnika.
• Rheumatoid arthritis,
• revmatoidni artritis,
Humira is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Zdravilo Humira je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
Ulcerative colitis is an inflammatory disease of the large intestine.
Ulcerozni kolitis je vnetna bolezen debelega črevesa.
Wipe the injection site in a circular motion with the alcohol pad.
o S krožnim gibom obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Humira je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Zdravilo Humira se uporablja za zdravljenje hidradenitis suppurativa pri mladostnikih, starejših od
If your child takes Humira the risk of getting lymphoma, leukemia, or other cancers may increase.
Če vaš otrok uporablja zdravilo Humira, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Rheumatoid arthritis
• revmatoidnega artritisa
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at Week 0 and 80 mg at Week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Vsi bolniki so nezaslepljeno prejeli indukcijsko zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg v tem vrstnem redu bolniki z < 40 kg.
The results for the 40 mg every other week dose are summarised in Table 4.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 4.
• severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
• hude kronične luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
• 1 pre-filled pen for patient use with 2 alcohol pads (1 spare)
• 1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema (1 dodatni)
The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week two weeks later.
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden dva tedna kasneje.
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile
• Do not use the pre-filled syringe if the liquid is cloudy or has particles
• Napolnjene injekcijske brizge ne uporabite, če je tekočina motna ali vsebuje delce
Humira treated patients showed statistically significant improvements at Week 26 compared with placebo in the DLQI.
Pri bolnikih, zdravljenih z zdravilom Humira, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a Humira trial in paediatric patients with chronic plaque psoriasis.
Pri 77 pediatričnih bolnikih v preskušanju zdravila Humira pri pediatričnih bolnikih s kronično psoriazo v plakih z izpostavljenostjo 80,0 bolnikov-let niso opazili malignomov.
• swollen face, hands, feet;
• oteklost obraza, dlani in stopal,
• erythema multiforme (inflammatory skin rash)
• multiformni eritem (vnetni kožni izpuščaj)
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.
13,5 % (24/178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7 % (14 od 198 bolnikov).
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 Humira.
Pred zdravljenjem z zdravilom Humira in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
• oral infections (including tooth infections and cold sores);
• okužbe ustne votline (vključno z okužbami zob in herpesom);
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 days * p < 0.001 for Humira versus placebo pairwise comparisons of proportions ** p < 0.02 for Humira versus placebo pairwise comparisons of proportions Of those receiving corticosteroids at baseline
Bolniki v remisiji brez steroidov ≥ 90 dnia * p < 0,001 za parne primerjave razmerij Humire proti placebu ** p < 0,02 za parne primerjave razmerij Humire proti placebu a Od teh, ki so dobivali kortikosteroide ob začetku
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml.
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
Vertigo and visual impairment may occur following administration of Humira (see section 4.8).
Po dajanju zdravila Humira se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
• trouble breathing, swallowing
• težave pri dihanju, požiranju
Do not touch the area again before injecting.
o Predela se pred injiciranjem ne dotikajte več.
• oral infections (including tooth infections and cold sores)
• okužbe ustne votline (vključno z okužbami zob in herpesom)
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Če se pri vas razvijejo novi simptomi srčnega popuščanja ali se ti poslabšajo (na primer kratka sapa ali otekanje nog), morate nemudoma obvestiti svojega zdravnika.