natgillin/translations-raw huggingface dataset:
Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), Autoantibody test positive (including double stranded DNA antibody),
pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA), zvišanje laktat dehidrogenaze v krvi
AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Zdravilo AMGEVITA je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
Week 16 Placebo-controlled
16. teden Kontrolirana s placebom26.
AMGEVITA is also used to treat severe 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.
Zdravilo AMGEVITA se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in zdravljenja s svetlobo nista dovolj dobro delovala ali pa nista primerna.
A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
A. Vzemite potrebno število napolnjenih injekcijskih brizg zdravila AMGEVITA iz škatle.
After 12 weeks of therapy, patients who had received adalimumab in Period A were rerandomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Po 12. tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (adalimumab 40 mg vsak teden, adalimumab 40 mg vsak drugi teden ali placebo od 12. do 35. tedna).
Important: Throw the needle cap into the sharps disposal container provided.
Pomembno: Pokrovček vrzite v vsebnik za ostre odpadke.
Two weeks later (day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Čez dva tedna (29. dan) nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (aplicirano v obliki dveh 40 mg injekcij v enem dnevu).
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 1,46 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumabtreated patients.
Endoskopske študije črevesne sluznice so pokazale znake celjenja sluznice pri bolnikih, zdravljenih z adalimumabom.
AMGEVITA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Zdravilo AMGEVITA je indicirano za zdravljenje hude psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se neustrezno odzvali na ali niso ustrezni kandidati za topikalno zdravljenje in fototerapije.
AMGEVITA is injected under the skin (subcutaneous use).
Zdravilo AMGEVITA se injicira pod kožo (subkutana uporaba).
After single intravenous doses ranging from 0.25 to 10 mg/kg,
Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Med bolniki, ki z vsaj delnim odzivom v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo z adalimumabom vsak teden, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 % in v
In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
V študiji UC-II je bilo 21/41 bolnikov (51 %), ki so bili zdravljeni z adalimumabom in so dosegli remisijo 8.teden, v remisiji 52. teden.
AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years and enthesitis-related arthritis in patients from 6 years.
Zdravilo AMGEVITA se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, in artritisa, povezanega z entezitisom, pri bolnikih od 6. leta starosti.
AMGEVITA contains sodium
Zdravilo AMGEVITA vsebuje natrij
If there is blood, press a cotton ball or gauze pad on your injection site.
Če opazite kri, na mesto injiciranja pritisnite s kosmom vate ali zložencem iz gaze.
What AMGEVITA contains - The active substance is adalimumab.
Kaj vsebuje zdravilo AMGEVITA - Zdravilna učinkovina je adalimumab.
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in PedACR 50 (PedACR - American College of Rheumatology pediatric) odzivom.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobnejše informacije o tem zdravilu so na voljo na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu
- The needle cap is missing or not securely attached.
- Manjka pokrovček igle ali ta ni varno nameščen.
a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba vsak drugi teden c MTX = metotreksat **p < 0,01, adalimumab v prim.
In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
V študiji pri Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost večkratnih odmerkov adalimumaba so ocenili pri odraslih z zmernim do zelo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
On a clean, well-lit work surface, place a new, pre-filled syringe.
Na čisto, dobro osvetljeno delovno površino položite nov napolnjen injekcijski peresnik.
Rhabdomyolysis, Systemic lupus erythematosus
občasni rabdomioliza, sistemski eritematozni lupus redki sindrom podoben lupusu1)
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva PASI 75 69,6 % in delež odziva PGA "čisto" ali "minimalno" 55,7 %.
Thirty-three (18%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
The window turns yellow When the injection is done
Ko je injiciranje končano, postane okence rumeno.
The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year versus 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year versus 0.22 per patient year.
Število hospitalizacij iz vseh razlogov v skupini, zdravljeni z adalimumabom, je bilo 0,18 na bolnikov-let proti 0,26 na bolnikov-let v placebo skupini.
In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
V eksploracijskem kliničnem preskušanju infliksimaba, drugega antagonista TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
• 160 mg at week 0 and 80 mg at week 2
• 160 mg v 0. tednu in 80 mg v 2.tednu
AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Zdravilo AMGEVITA je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
Pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo je zvečano osnovno tveganje za limfome in levkemijo, kar komplicira oceno tveganja.
• Adults with non-infectious uveitis with inflammation affecting the back of the eye.
• odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa.
AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Rentgensko slikanje je pokazalo, da zdravilo AMGEVITA upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
If you have mild heart failure and you are being treated with AMGEVITA, your heart failure status must be closely monitored by your doctor.
• Če imate blago srčno popuščanje in se zdravite z zdravilom AMGEVITA, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your rheumatoid arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo AMGEVITA.
K. Examine the injection site.
K. Preglejte mesto injiciranja.
CD study II: infliximab experienced patients
Študija pri Crohnovi bolezni II: Bolniki, ki so že dobivali infliksimab
Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).
Eno pakiranje vsebuje 1, 2, 4 ali 6 40 mg napolnjenih injekcijskih brizg (z modrim batom brizge).
AMGEVITA is administered every other week via subcutaneous injection.
Zdravilo AMGEVITA se odmerja vsak drugi teden v obliki subkutane injekcije.
Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNFα) inhibitors.
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje-nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04.
If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Če je s 40 mg vsak teden ali 80 mg vsak drugi teden dosežen zadosten odziv na zdravljenje, se lahko odmerek pozneje zmanjša na 40 mg vsak drugi teden.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of AMGEVITA should be promptly discontinued.
Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of AMGEVITA for patients with polyarticular juvenile idiopathic arthritis, from 2 years of age is based on body weight (table 1).
Pediatrična populacija Juvenilni idiopatski artritis Poliartikularni juvenilni idiopatski artritis od 2. leta starosti Priporočeni odmerek zdravila AMGEVITA pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
AMGEVITA is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Zdravilo AMGEVITA je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
By Week 68, patients receiving continuous adalimumab 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 adalimumab v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
Statistically and clinically significant improvements from baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kvalitete življenja (vključno z IMPACT III) glede na začetek študije.
Make sure the medicine in the syringe is clear and colourless to slightly yellow.
Prepričajte se, da je zdravilo v brizgi bistro in brezbarvno do rahlo rumenkasto.
AMGEVITA Dose for Paediatric Patients with Crohn's disease
Odmerjanje zdravila AMGEVITA pri pediatričnih bolnikih s Crohnovo boleznijo
Multipack: 6 (3 packs of 2) pre-filled syringes.
Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week (eow).
Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg adalimumaba vsak drugi teden.
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
• sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo,
LIST OF EXCIPIENTS Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
SEZNAM POMOŽNIH SNOVI Ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
Table 29.
Preglednica 29.
Marketing Authorisation Holder Amgen Europe B.V.
Imetnik dovoljenja za promet Amgen Europe B.V.
The combination of AMGEVITA and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila AMGEVITA in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
Table 23.
Preglednica 23.
Pinch the skin firmly between your thumb and fingers, creating an area about 2 inch (5 centimetres) wide.
Kožno gubo čvrsto držite med palcem in prsti, da nastane približno 5 centimetrov široka površina.
In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Pri 84% preiskovancev, ki so dobivali adalimumab in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
Week 26 Placebo-controlled
teden Kontrolirana s placebom
● Do not remove the needle cap until you are ready to inject.
● Ne odstranjujte pokrovčka igle, dokler niste pripravljeni za injiciranje.
• oral infections (including tooth infections and cold sores);
• okužbe ustne votline (vključno z okužbami zob in ocvirki);
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okužbe, to takoj povejte zdravniku.
Keep AMGEVITA in the outer carton in order to protect from light.
Zdravilo AMGEVITA shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
In controlled trials of adalimumab (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 adalimumab-treated patients and 0.6% of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v 0. tednu, 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 adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
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 AMGEVITA therapy.
Za pediatrične bolnike je priporočljivo, da pred začetkom zdravljenja z zdravilom AMGEVITA opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
40 mg adalimumab every other week
40 mg adalimumaba vsak drugi teden
- The other ingredients are glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
- Pomožne snovi so ledocet, saharoza, polisorbat 80, natrijev hidroksid in voda za injekcije.
Used plunger rod Finger flange
Uporabljen bat Oprijemalo za prste
ACR responses in placebo-controlled trials (percent of patients)
Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
Radiographic mean changes over 12 months in RA study III
Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
Children and adolescents with plaque psoriasis
Otroci in mladostniki z luskavico (psoriazo) v plakih
Table 28.
Preglednica 28.
Each pack contains 1 single-use 20 mg pre-filled syringe (with yellow plunger rod).
Eno pakiranje vsebuje 1 20 mg napolnjeno injekcijsko brizgo za enkratno uporabo (z rumenim batom brizge).
Pulmonary embolism1), Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
pogosti astma, dispneja, kašelj občasni pljučni embolizem intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralna efuzija1)
In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX
V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Delež (95 % interval zaupanja) nemelanomskih kožnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
Radiographic mean changes at week 52 in RA study V
Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
● Put the used AMGEVITA syringe in a sharps disposal container immediately after use.
● Uporabljen napolnjen injekcijski peresnik nemudoma po injiciranju dajte v vsebnik za ostre odpadke.
If you forget to use AMGEVITA
Če ste pozabilli uporabiti zdravilo AMGEVITA
In controlled trials of adalimumab (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 adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (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 do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z adalimumabom in pri 2,4 % bolnikov v kontrolni skupini.
● Do not remove the needle cap from the syringe until you are ready to inject.
● Ne odstranjujte pokrovčka igle z brizge, dokler niste pripravljeni za injiciranje.
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 AMGEVITA.
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom AMGEVITA ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo).
The recommended dose of AMGEVITA for patients with Crohn's disease from 6 to 17 years of age is based on body weight (table 4).
Priporočeni odmerek zdravila AMGEVITA pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).