natgillin/translations-raw huggingface dataset:
• Prepare the needle by partially peeling the package open from the end closest to the yellow syringe connector.
• Pripravite iglo: delno odprite njeno ovojnino tako, da ga odlepite od konca, ki je najbližji rumenemu konektorju za brizgo.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Med obdobjem trženja so bili opisani malignomi (nekateri s smrtnim izidom) pri otrocih, mladostnikih in mladih odraslih (starih do 22 let), ki so dobivali antagoniste TNF, vključno z adalimumabom (začetek zdravljenja v starosti ≤ 18 let).
You will see a yellow indicator move into the window during the injection.
Med injiciranjem boste videli pomikanje rumenega kazalnika v okence.
The active substance is adalimumab.
Učinkovina je adalimumab.
This medicine has been prescribed for your child only.
- Zdravilo je bilo predpisano samo vašemu otroku in ga ne smete dajati drugim.
Some of those patients were also treated with azathioprine or 6mercaptopurine.
Nekateri od teh bolnikov so bili zdravljeni tudi z azatioprinom ali 6-merkaptopurinom.
• allergic reactions (including seasonal allergy)
• alergijske reakcije (vključno s sezonskimi alergijami)
The primary endpoint was the percent change from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of62.6% (median percent change -88.9%) in patients in the Humira group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala zdravilo Humira v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
Tell your doctor as soon as possible if you notice any of the following
Zdravniku čim prej povejte, če opazite kaj od naslednjega
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.
Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
Greater improvements at Week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Večja izboljšanja v 12. tednu glede na izhodiščno vrednost v primerjavi s placebom so bila prikazana v kakovosti življenja, povezani s koži specifičnim zdravjem, merjena z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenim z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF 36) v študiji HS-I).
The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Odstotek bolnikov, zdravljenih z zdavilom Humira, ki so dosegli odziv 20, 50 in 70 po ACR, se je v študijah revmatoidnega artritisa I, II in III skladal.
≥ mNAPSI 75 (%) PGA-F clear/minimal and ≥2-grade improvement (%)
PGA-F čisto/minimalno in ≥ izboljšanje za dve stopnji
After Week 2, patients in both adalimumab arms received 40 mg eow.
Po 2. tednu so bolniki v obeh krakih z adalimumabom prejemali 40 mg vsak drugi teden.
• Your child and his/her doctor should pay special attention to signs of infection while your child is being treated with Humira.
• Vaš otrok in njegov zdravnik morata biti posebej pozorna na znake okužbe, medtem ko se vaš otrok zdravi z zdravilom Humira.
Do not try to touch the needle.
Ne poskušajte se dotakniti igle.
A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Od bolnikov, deležnih ponovnega zdravljenja, jih je skupno 76,5 % (218/285) po 16 tednih ponovnega zdravljenja imelo odziv PGA "čisto" ali "minimalno", ne glede na to, ali je med prenehanjem uporabe prišlo do relapsa (69,1 % [123/178] bolnikov, pri katerih je med prenehanjem uporabe prišlo do relapsa, in 88,8 % [95/107] tistih, pri katerih ni prišlo do relapsa).
1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
1 viala (0,8 ml sterilne raztopine), 1 prazna sterilna injekcijska brizga 1 igla, 1 adapter za vialo in 2 alkoholna zloženca.
Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Klinična remisija pomeni oceno Mayo ≤ 2 in nobene podocene > 1;
Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding in place without moving).
Držite telo napolnjenega injekcijskega peresnika in peresnik rahlo pritisnite na mesto injiciranja (držite ga na mestu, ne da bi ga premikali).
Patients in rheumatoid arthritis studies I, II and III were tested at multiple time points for anti-adalimumab antibodies during the 6 to 12 month period.
Bolniki v študijah revmatoidnega artritisa I, II in III so bili v obdobju med 6. in 12. mesecem testirani za protitelesa proti adalimumabu.
In the Phase 3 trial of Humira in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
V preskušanju faze 3 z zdravilom Humira pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Zdravilo Humira se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let, in artritisa, povezanega z entezitisom pri otrocih in mladostnikih starih od 6 do 17 let.
2) Preparing the Humira dose for injection
2) Priprava odmerka zdravila Humira za injiciranje
Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Ne pritisnite škrlatnega sprožilnega gumba, dokler peresnik ni pravilno nameščen, ker boste sicer iztisnili zdravilo.
• After the needle is in, let go of the skin you are holding
• Ko je igla v koži, spustite kožo, ki jo držite
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were  18 years old.
V študiji revmatoidnega artritisa IV je bila v prvi vrsti ocenjena varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
These results suggest that some patients who have not responded by Week 4 benefit from continued maintenance therapy through Week 12.
Ti rezultati nakazujejo, da nekaterim bolnikom, ki se ne odzovejo do 4. tedna, koristi nadaljevanje vzdrževalnega zdravljenja do
Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Podatki, ki so na voljo, kažejo, da je klinični odziv po navadi dosežen v 2-8 tednih zdravljenja.
Clinical remission Clinical response (CR
Klinična remisija Klinični odziv (CR
Taking these results into consideration, Humira is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Z upoštevanjem teh ugotovitev je zdravilo Humira priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
• Humira can be used during breast-feeding.
• Zdravilo Humira se lahko uporablja med dojenjem.
Hold the pre-filled pen so that you can see the inspection window.
Napolnjen injekcijski peresnik držite, tako da lahko vidite kontrolno okence.
Prescribers should exercise caution in considering the use of Humira in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Humira should be considered if any of these disorders develop.
Pri odločanju za uporabo zdravila Humira pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Humira.
Placebo (treatment withdrawal) N = 73
Placebo (ukinitev zdravljenja) N = 73
673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received Humira 40 mg eow for 28 weeks.
673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na vsaj dva NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali zdravilo Humira 40 mg vsak drugi teden 28 tednov.
the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
The conduct and results of these tests should be recorded on your Patient Reminder Card.
Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici za bolnika.
Humira treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Bolniki, ki so dobivali zdravilo Humira, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu - Ankylosing Spondylitis Quality of Life Questionnaire).
The combination of Humira and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila Humira in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
If you use more Humira than you should
Če ste uporabili večji odmerek zdravila Humira, kot bi smeli
TNF-antagonists including Humira have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including GuillainBarré syndrome.
Antagonisti TNF, z zdravilom Humira vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barréjevim sindromom.
Look at the expiry date on the syringe.
• Preverite datum izteka roka uporabnosti na brizgi.
The white needle sleeve will cover the needle tip.
Bel tulec bo prekril konico igle.
Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
b Med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži.
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 Humira and 5.4% for control treated patients.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala zdravilo Humira, in 5,4 % v kontrolni skupini.
Tell your doctor immediately if you notice any of the following
Svojemu zdravniku takoj povejte, če opazite kaj od naslednjega
The pre-filled pen is now ready to use.
Napolnjeni injekcijski peresnik je zdaj pripravljen za uporabo.
If you stop using Humira
Če ste prenehali uporabljati zdravilo Humira
Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.
Artritis, povezan z entezitisom je vnetna bolezen sklepov in in mest, kjer se tetive prirastejo na kost.
• On rare occasions, treatment with Humira could result in lupus-like syndrome.
• V redkih primerih lahko zdravljenje z zdravilom Humira povzroči lupusu podoben sindrom.
Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at Week 52 in RA study III.
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire), ki je bila v študiji revmatoidnega artritisa III vnaprej določena primarna končna točka po 52 tednih.
In patients with moderate to severe hidradenitis suppurativa, anti-adalimumab antibodies were identified in 10/99 subjects (10.1%) treated with adalimumab.
Pri bolnikih z zmerno do hudo obliko hidradenitis suppurativa so bila protitelesa proti adalimumabu odkrita pri 10/99 oseb (10,1 %), ki so bile zdravljene z adalimumabom.
The needle will then be covered by the automatic needle guard.
Avtomatski ščitnik za iglo bo nato pokril iglo.
• Do not remove the needle cover while allowing Humira to reach room temperature
• Pokrovčka igle ne odstranite dokler zdravilo Humira ne doseže sobne temperature.
Mark your calendar with the stickers provided to remind you of the date for your next dose.
S priloženimi nalepkami si na koledarju označite datum, ko morate vzeti naslednji odmerek.
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.
Od 424 bolnikov, ki so bili vključeni v nekontrolirani dolgoročni podaljšek študij UV I in UV II, je bilo 60 bolnikov neprimernih (npr. zaradi odstopanj ali zapletov, sekundarno ob diabetični retinopatiji zaradi kirurškega posega sive mrene ali vitrektomije) in so bili izključeni iz primarne analize učinkovitosti.
The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu, je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1.31, 95 % interval zaupanja 0.38-4.52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1.14, 95 % interval zaupanja 0.31-4.16).
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Humira therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Humira in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
• Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe
• Napolnjeno injekcijsko brizgo z eno roko držite v višini oči, tako da lahko vidite zrak v napolnjeni injekcijski brizgi
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot kožni izpuščaj, ki ga spremlja mišična šibkost)
Patients taking TNF -antagonists are more susceptible to serious infections.
Bolniki, ki uporabljajo antagoniste tumor nekrotizirajočega faktorja (TNF), so bolj dovzetni za resne okužbe.
• With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
• Z drugo roko držite brizgo pod kotom 45 stopinj na kožo, z užlebljenim delom obrnjenim navzgor.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Po uporabi zdravilaHumira se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP-1 in MMP-3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
Psoriasis Study IV compared efficacy and safety of Humira versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Študija pri psoriazi IV je primerjala učinkovitost in varnost zdravila Humira v primerjavi s placebom pri 217 odraslih bolnikih z zmerno do hudo psoriazo nohtov.
The Humira pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
Napolnjeni injekcijski peresnik zdravila Humira je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih peresnikov.
Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Med bolniki, ki so izgubili ustrezen odziv ob ponovni randomizaciji na placebo med podaljšanim odprtim preskušanjem, je po 12 tednih ponovne terapije PASI 75 znova doseglo 38 % (25/66), po 24 tednih pa 55 % (36/66) bolnikov.
Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Zmanjšanje inflamatornih lezij in preprečevanje poslabšanja abscesov in fistul z izcedkom so ocenili z rezultatom kliničnega odziva pri hidradenitis suppurativa (HiSCR - Hidradenitis Suppurativa Clinical Response; najmanj 50 % zmanjšanje skupnega števila abscesov in inflamatornih nodulov brez povečanja števila abscesov in fistul z izcedkom glede na izhodiščno število).
Psoriasis Study III (REACH) compared the efficacy and safety of Humira versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Študija pri psoriazi III (REACH) je primerjala učinkovitost in varnost zdravila Humira v primerjavi s placebom pri 72 bolnikih z zmerno do hudo kronično psoriazo v plakih in psoriazo na dlaneh in/ali stopalih.
• opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
• oportunistične okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen)
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
• avtoimunski hepatitis (vnetje jeter, ki ga povzroči lastni imunski sistem)
No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z zdravilomHumira, ni.
Humira is used to treat
Zdravilo Humira se uporablja za zdravljenje
Ped ACR 30/50/70 responses Week 48 significantly greater than those of placebo treated patients p = 0.015 c p = 0.031
> 32 tednov 14 tednov a Odzivi »Ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015 c p = 0,031
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
• With one hand, gently grasp the cleaned areas of skin and hold firmly
• Z eno roko obzirno primite očiščeni predel kože in ga trdno držite.
Among patients whose Humira treatment was withdrawn at Week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of Humira 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Med bolniki, pri katerih je bilo zdravljenje z zdravilom Humira ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi zdravila Humira 40 mg enkrat na teden raven kliničnega odziva (HiSCR) vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
Week 2
2. tednu.
A single Humira pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Posamezna napolnjena injekcijska brizga zdravila Humira se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 14 dni.
Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Poročali so tudi o melanomu in karcinomu Merklovih celic pri bolnikih, zdravljenih z antagonisti TNF , vključno z adalimumabom (glejte poglavje 4.8).
fungal infections,
glivične okužbe,
• mood swings (including depression)
• spremenljivo razpoloženje (vključno z depresijo)
A total of 233 PASI 75 responders at Week 16 and Week 33 received continuous Humira therapy for 52 weeks in Psoriasis Study I, and continued Humira in the open-label extension trial.
Skupno je 233 bolnikov, ki so imeli 16. in 33. teden odziv PASI 75, v študiji psoriaze I prejemalo stalno zdravljenje z zdravilom Humira 52 tednov ter so zdravljenje z zdravilom Humira nadaljevali v odprtem podaljšanem preskušanju.
Treatment with Humira may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom Humira lahko povzroči nastanek avtoimunskih protiteles.
One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Eno pakiranje vsebuje 2 škatli, ena škatla pa vsebuje 1 vialo, prazno sterilno injekcijsko brizgo, 1 iglo, 1 adapter za vialo in 2 alkoholna zloženca.