natgillin/translations-raw huggingface dataset:
The safety and efficacy of Humira was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Varnost in učinkovitost zdravila Humira sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do manj kot 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
• facial oedema (swelling of the face)
• edem obraza (otekanje obraza)
• neurological infections (including viral meningitis)
• nevrološke okužbe (vključno z virusnim meningitisom)
years.
6 let.
Excipients: mannitol, polysorbate 80 and water for injections.
Pomožne snovi: manitol, polisorbat 80 in voda za injekcije.
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 26 weeks followed by open-label Humira treatment for an additional 26 weeks.
Bolniki so prejeli začetni odmerek 80 mg zdravila Humira, ki mu je sledil 40 mg odmerek vsak drugi teden (z začetkom en teden po začetnem odmerku) ali placebo naslednjih 26 tednov, čemur je sledilo odprto zdravljenje z zdravilom Humira dodatnih 26 tednov.
In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.
Izkušenj z zdravilom Humira pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega zdravljenja z metotreksatom ni.
Humira n=274
Zdravilo Humira n = 274
You may first be given other disease-modifying medicines, such as methotrexate.
Morda boste najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
• shortness of breath with physical activity or upon lying down or swelling of the feet
• težko dihanje ob telesni dejavnosti ali med ležanjem ali otekanje nog
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.
Zdravilo Humira je indicirano za zdravljenje kroničnega, neinfekcijskega, anteriornega uveitisa pri bolnikih, starejših od 2 let, ki se niso ustrezno odzvali ali ne prenašajo konvencionalnega zdravljenja, ali pri katerih konvencionalno zdravljenje ni primerno.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of Humira and azathioprine/6-mercaptopurine compared with Humira alone.
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi zdravila Humira in azatioprina/6merkaptopurina opazili večjo incidenco malignih in resnih z okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z zdravilom Humira.
It is important to tell your doctor if your child has had or has a serious heart condition.
Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima kakšno resno bolezen srca.
In adult patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.
Pri odraslih bolnikih z neinfekcijskim uveitisom so bila protitelesa proti adalimumabu odkrita pri 4,8 % (12/249) bolnikov, ki so jih zdravili z adalimumabom.
• At least 3 cm from your child's last injection site
• najmanj 3 cm oddaljeno od otrokovega prejšnjega mesta injiciranja.
• high blood measurements for lactate dehydrogenase
• visoke krvne vrednosti za laktat dehidrogenazo
• intestinal perforation (hole in the intestine)
• intestinalna perforacija (predrtje črevesa)
• Only use each pre-filled syringe for one injection.
• Vsak napolnjen injekcijski peresnik uporabite le za eno injiciranje.
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukemia (a cancer that affects the blood and bone marrow).
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rak, ki prizadene limfatični sistem) in levkemijo (rak, ki prizadene kri in kostni mozeg).
blood lactate dehydrogenase increased
zvišanje laktat dehidrogenaze v krvi
Your symptoms may return upon discontinuation.
Vaši simptomi se lahko po prekinitvi zdravljenja povrnejo.
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 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.
4) Throwing away supplies
4) Kako zavreči ostanke
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
(20,1 %) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %)
Most patients continued on Humira after the infection resolved.
Večina bolnikov je po ozdravitvi okužbe nadaljevala zdravljenje z zdravilom Humira.
Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
52. teden 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043 104. teden 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
Table 29 Time to Treatment Failure in Studies UV I and UV II
Preglednica 29 Čas do neuspeha zdravljenja v študijah UV I in UV II
In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
V kontroliranih in odprtih študijah pri odraslih in otrocih z zdravilom Humira so poročali o resnih okužbah (vključno s smrtno nevarnimi, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
Immunosuppressant therapy could only be discontinued at or after Week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
2Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
• Crohn's disease
• Crohnove bolezni
and
e
40 mg every other week
40 mg vsaki drugi teden
o One 1 ml syringe (1)
Guillain-Barré sindrom)1)
Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with Humira compared to placebo (Table 14).
Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z zdravilom Humira v primerjavi s placebom (preglednica14).
• sensation of heart beating rapidly
• občutek hitrega bitja srca
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Ugotovljeni delež nemelanomskih rakov je približno 0,2 na 1000 bolnikov-let zdravljenja in limfomov približno 0,3 na 1000 bolnikov-let zdravljenja(glejte poglavje 4.4).
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni.
Each pack contains 1, 2 or 6 pre-filled syringes for patient use with 1, 2 or 6 alcohol pads, respectively.
Eno pakiranje vsebuje 1, 2 oz. 6 napolnjenih injekcijskih brizg za bolnikovo uporabo z 1, 2 oz. 6 alkoholnimi zloženci.
• Ulcerative colitis
• ulceroznega kolitisa
Pull the Plum-coloured Cap 2 straight off.
Odstranite škrlaten pokrovček (2).
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.
Uporabo zdravila Humira 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih zdravljenih z zdravilom Humira in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
Then give your child's next dose as you would have on the originally scheduled day, had you not forgotten a dose.
Nato dajte vašemu otroku naslednji odmerek, kot bi ga uporabili po prvotnem urniku, če ne bi pozabili odmerka.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Humira.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem lahko še nadalje uporabljajo ob uporabi zdravila Humira.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at Week 52, which was maintained through Week 104.
V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z zdravilom Humira in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z zdravilom Humira; to se je ohranilo do 104. tedna.
Humira is administered via subcutaneous injection.
Zdravilo Humira se uporablja kot subkutana injekcija.
Hypersensitivity, allergies (including seasonal allergy)
pogosti občasni redki preobčutljivost, alergije (vključno s sezonsko alergijo)
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.
Zdravilo Humira je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
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.
Delež (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) 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.
Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Preglednica 14 Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Pri uporabi tega zdravila natančno upoštevajte navodila otrokovega zdravnika ali farmacevta.
The long halflife of adalimumab should be taken into consideration if a surgical procedure is planned.
Če je predviden kirurški poseg, je treba upoštevati dolg razpolovni čas adalimumaba.
At Week 12, a significantly higher proportion of patients treated with Humira versus placebo achieved HiSCR.
V 12. tednu je statistično pomembno večji delež bolnikov, ki so prejemali zdravilo Humira, doseglo klinični odziv (HiSCR) v primerjavi z bolniki, ki so prejemali placebo.
• elevated bilirubin measurement (liver blood test)
• povečane vrednosti bilirubina (krvni test jetrne funkcije)
• respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
• okužbe dihalnega trakta (vključno s prehladom, izcedkom iz nosu, okužbo sinusov, pljučnico)
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).
Povprečne (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6.1 μg/ml pri bolnikih < 40 kg (80/40 mg).
Note: P# = Placebo (Number of Events/Number at Risk); A# = HUMIRA (Number of Events/Number at Risk).
Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = HUMIRA (število dogodkov/število rizičnih preiskovancev).
Your doctor will decide if you should receive Humira.
Vaš zdravnik bo odločil, ali lahko prejemate zdravilo Humira.
Humira N=208
Zdravilo Humira n = 208
P value
vrednost p
In patients with ankylosing spondylitis anti-adalimumab antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab.
Med bolniki z ankilozirajočim spondilitisom so protitelesa proti adalimumabu ugotovili pri 17/204 (8,3 %) tistih, ki so dobivali adalimumab.
• 160 mg at Week 0 and 80 mg at Week 2
• 160 mg v 0. tednu in 80 mg v 2. tednu
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.
V kontroliranih preskušanjih faze 3 z zdravilom Humira pri bolnikih z juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov zdravljenih z zdravilom Humira, in pri 1,3 % bolnikov v kontrolni skupini.
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to Week 12, with a maximum dose of 25 mg or an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Bolniki so dobivali placebo, začetni odmerek 7,5 mg metotreksata z nadaljnjim povečanjem odmerka do 12. tedna; do največjega odmerka 25 mg, ali začetni odmerek 80 mg zdravila Humira in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
Table 21: Efficacy Results at 12 Weeks, HS Studies I and II HS Study I
Preglednica 21: Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
SYRINGE LABEL
OZNAČITEV NA BRIZGI
• abnormal muscle breakdown;
• brazgotinjenje; • neobičajen razpad mišic;
In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
V pivotnih preskušanjih so protitelesa proti adalimumabu odkrili pri 5,5 % (58/1053) bolnikov, ki so jih zdravili z adalimumabom v primerjavi z 0,5 % (2/370) bolnikov,
The recommended Humira induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at Week 0 followed by 40 mg at Week 2.
Priporočena shema odmerjanja zdravila Humira med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
The safety and efficacy of Humira in children aged 4-17 years have been established for plaque psoriasis.
Varnost in učinkovitost zdravila Humira pri otrocih s psoriazo v plakih, starih 4-17 let, je bila potrjena.
In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.
Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Humira pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
You will be instructed by your doctor or his/her assistant on the technique of self-injection.
Zdravnik ali njegovo osebje vas bodo naučili, kako si zdravilo injicirate sami.
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Navidezna koncentracija adalimumaba v plazmi, ki doseže polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila
In adult patients with psoriasis, anti-adalimumab antibodies were identified in 77/920 subjects (8.4%) treated with adalimumab monotherapy.
Pri odraslih bolnikih s psoriazo so bila protitelesa proti adalimumabu odkrita pri 77/920 oseb (8,4 %), ki so bile zdravljene z monoterapijo adalimumaba.
Table 8 Ped ACR 30 Responses in the JIA study
Preglednica 8 Odzivi »Ped ACR« 30 v študiji pri juvenilnem idiopatskem artritisu
• certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine,
• nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (npr. sulfasalazinom,
Humira Dose for Paediatric Patients with Plaque Psoriasis
Odmerjanje zdravila Humira pri pediatričnih bolnikih s psoriazo v plakih
The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.
Napolnjena injekcijska brizga zdravila Humira je steklena brizga, ki vsebuje raztopino adalimumaba.
• Merkel cell carcinoma (a type of skin cancer)
• karcinom Merklovih celic (tip kožnega raka)
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 vse primerjave med zdravilom Humira in placebom * p < 0,05 za vse primerjave med zdravilom Humira in placebom np ne pride v poštev
Gently pull the needle cover straight off with the other hand.
Z drugo roko nežno odstranite pokrovček igle.
The recommended dose of Humira is 20 mg every other week.
Priporočeni odmerek zdravila Humira je 20 mg vsak drugi teden.
• eye infections
• okužba oči
Patients in steroid-free remission for >=90 days
Bolniki v remisiji brez steroidov za ≥ 90 dnia
• nerve root compression (including low back pain and leg pain);
• stisnenje živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
The Humira pre-filled pen is a single-use grey and plum-coloured pen which contains a glass syringe with Humira.
Napolnjeni injekcijski peresnik zdravila Humira je peresnik sive in škrlatne barve za enkratno uporabo, ki vsebuje stekleno brizgo z zdravilom Humira.
In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/40 mg and 160/80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
V študiji Crohnove bolezni I in študij Crohnove bolezni II je bilo v 4. tednu doseženo statistično pomembno izboljšanje skupnega rezultata za bolezen specifičnega vprašalnika za vnetno bolezen črevesa (IBDQ-inflammatory bowel disease questionanaire-) pri bolnikih, ki so bili randomizirani na zdravilo Humira 80/40 mg in 160/80 mg v primerjavi s placebom.
• sicca syndrome (including dry eyes and dry mouth)
• Sjögrenov sindrom (vključno s suhimi očmi in suhimi usti)
Humira is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Zdravilo Humira se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa in artritisa, povezanega z entezitisom.
• low blood measurements for phosphate
• nizke krvne vrednosti za fosfat
• 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.
• Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Humira.
In patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years, anti-adalimumab antibodies were identified in 15.8% (27/171) of patients treated with adalimumab.
Med bolniki s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let, so protitelesa proti adalimumabu ugotovili pri 15,8 % (27/171) bolnikov, ki so dobivali adalimumab.
Table 11: Efficacy Results at 12 Weeks, HS Studies I and II
Preglednica 11: Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
• Psoriatic arthritis,
• psoriatični artritis,
You can press a cotton ball or a piece of gauze over the injection site for 10 seconds.
S kosmom vate ali koščkom gaze lahko 10 sekund pritiskate na mesto injiciranja.
• sensation disorders such as tingling, prickling or numbness
• otežkočeno spanje • motnje v občutenju kot so ščemenje, zbadanje ali omrtvelost
• liquid is cloudy, discoloured, or has flakes or particles in it
• je tekočina motna, je spremenila barvo ali vsebuje kosmiče ali delce,
• Tuberculosis can develop during therapy even if your child has received treatment for the prevention of tuberculosis.
• Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok prejel preventivno zdravljenje za tuberkulozo.
Note: P = Placebo (Number at Risk); H = HUMIRA (Number at Risk).
Opomba: P = placebo (število rizičnih preiskovancev); H = HUMIRA (število rizičnih preiskovancev).
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Humira.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
V študiji Crohnove bolezni II je bilo 325 bolnikov, ki so postali neodzivni ali so imeli intoleranco na infliksimab, randomiziranih, da so prejeli ali 160 mg zdravila Humira v 0. tednu in 80 mg v 2. tednu ali placebo v 0. in 2. tednu.
Heart failure
Težave s srcem
What Humira is and what it is used for What you need to know before you use Humira How to use Humira
Kaj je zdravilo Humira in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Humira Kako uporabljati zdravilo Humira
Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Humira.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Humira ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje telesne mase, nekoliko zvišano telesno temperaturo, ravnodušnost).