natgillin/translations-raw huggingface dataset:
If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting AMGEVITA.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila AMGEVITA posvetujte s svojim zdravnikom.
Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.
• Zdravniku morate povedati, če živite na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
● It is important that you do not try to give the injection unless you or your caregiver has received training.
● Pomembno je, da vi ali oseba, ki za vas skrbi, zdravila ne poskušate injicirati sami, dokler vas ali osebo, ki za vas skrbi, tega ne nauči zdravstveni delavec.
After proper training in injection technique, patients may self-inject with AMGEVITA if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo AMGEVITA lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom AMGEVITA natančno kontrolirati glede okužb, vključno s tuberkulozo.
If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, dobili zdravilo AMGEVITA.
AMGEVITA is used to treat
Zdravilo AMGEVITA se uporablja za zdravljenje
● Sharps disposal container
● Vsebnik za odlaganje ostrih odpadkov
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
• znaki in simptomi, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
When combining controlled portions of these trials and ongoing and completed open-label extension studies of adalimumab, with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z adalimumabom z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
AMGEVITA may have a minor influence on the ability to drive and use machines.
Zdravilo AMGEVITA ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost adalimumaba so ocenili pri več kot 1500 bolnikih z zmerno do hudo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more AMGEVITA and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Če doživite alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila AMGEVITA ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated.
Zdravljenje z zdravilom AMGEVITA mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezenskih stanj, za katere je zdravilo AMGEVITA indicirano.
Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
24. teden 36. teden a Bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja b Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali pri njih ni bilo izboljšanja, so bili izključeni iz študij in so se šteli kot bolniki brez odgovora (“nonresponders”)
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo AMGEVITA je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab.
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo adalimumaba.
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Zdravilo AMGEVITA je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
AMGEVITA reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function.
Rentgensko slikanje je pokazalo, da zdravilo AMGEVITA upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularnimi, simetričnimi podtipi bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA.
Povejte zdravniku, če vaš otrok prejema azatioprin ali 6-merkaptopurin sočasno z zdravilom AMGEVITA.
Clinical response is usually achieved within 12 weeks of treatment.
Klinični odziv je ponavadi dosežen v 12 tednih zdravljenja.
Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0%).
Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi adalimumaba 40 mg enkrat na teden raven kliničnega odziva (HiSCR) po 12. tednih vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
• 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 antirevmatična zdravila, vključno z metotreksatom, ni zadosten.
● Do not recycle the syringe or sharps disposal container or throw them into the household waste.
● Ne reciklirajte brizge ali vsebnika za ostre odpadke ter ju ne vrzite med gospodinjske odpadke.
PGA: Clear/minimalc a MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX c P = 0.083, adalimumab 0.8 mg/kg versus MTX
PASI 75b PGA: čisto/minimalnoc a MTX = methotrexate b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
● Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.
● Ne vračajte napolnjenega injekcijskega peresnika nazaj v hladilnik, ko je le-ta dosegel sobno temperaturo.
In rheumatoid arthritis, methotrexate is continued while using AMGEVITA.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila AMGEVITA nadaljuje.
Your doctor will decide if you should receive AMGEVITA.
On se bo odločil, ali lahko dobivate zdravilo AMGEVITA.
ASASa,b 20
ASASa,b 20 ASASa,b 40 ASAS
TNF-antagonists including adalimumab 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 Guillain-Barré syndrome.
Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom 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-Barré- jevim sindromom.
In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
If you stop using AMGEVITA
Če ste prenehali uporabljati zdravilo AMGEVITA
- The yellow cap is missing or not securely attached.
- manjka rumeni pokrovček igle ali ta ni varno nameščen.
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,8 ml odmerek, kar v bistvu pomeni 'brez natrija'.
Mood alterations (including depression), Anxiety,
Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo), anksioznost, nespečnost
Usually, AMGEVITA is used with methotrexate.
Zdravilo AMGEVITA ponavadi uporabljamo z metotreksatom.
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva 5 mesecev po zadnji injekciji adalimumaba, ki jo je mati prejela med nosečnostjo.
Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II
• AMGEVITA can be used during breast-feeding.
• Zdravilo AMGEVITA se lahko uporablja med dojenjem.
AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Zdravilo AMGEVITA je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2.leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil (disease-modifying anti-rheumatic drugs - DMARDs).
ACR 50 6 months 12 months
ACR 50 6 mesecev 12 mesecev
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p < 0.001) (Figure 1).
Pri večjem deležu bolnikov, ki so prejemali adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
Administration of live vaccines (e.g., BCG vaccine) to infants exposed to AMGEVITA in utero is not recommended for 5 months following the mother's last AMGEVITA injection during pregnancy.
Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni zdravilu AMGEVITA in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji zdravila AMGEVITA med nosečnostjo.
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex) (see section 4.4).
Pokrovček igle na napolnjenem injekcijskem peresniku vsebuje suho naravno gumo (derivat lateksa) (glejte poglavje 4.4).
Adalimumab 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.
Adalimumab je pokazal statistično večje izboljšanje skupnega števila točk v HAQ-S vprašalniku in točk v telesno komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
Uncommon (may affect up to 1 in 100 people) • elevated bilirubin measurement (liver blood test).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • povečane vrednosti bilirubina (krvni test jeterne funkcije).
Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.
Kožo čvrsto raztegnite tako, da palec in prste razmaknete v nasprotni smeri in tako ustvarite približno 5 centimetrov širok predel.
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni.
Place your finger or thumb on edge of tray to secure it while you remove the syringe.
S prstom ali palcem primite za rob pretisnega omota, da se ne premika, medtem ko boste vzeli brizgo iz njega.
After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden, kot vam bo predpisal zdravnik.
F. Stretch or pinch your injection site to create a firm surface.
F. Raztegnite ali stisnite mesto injiciranja, da boste ustvarili trdno površino.
ACR 70 6 months 12 months
ACR 70 6 mesecev 12 mesecev
If you are about to undergo surgery or dental procedures please inform your doctor that you are taking AMGEVITA.
• Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete zdravilo AMGEVITA.
Subjects (n = 215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomised to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z adalimumabom 40 mg vsak drugi teden (N = 152) ali placebo (N = 153) dodatnih 40 tednov v dvojno slepem, s placebom kontroliranem obdobju (celotno trajanje študije 68 tednov).
The pre-filled syringe must be protected from light, and discarded if not used within the 14-day period.
Napolnjena injekcijska brizga mora biti zaščitena pred svetlobo in zavržena, če je ne uporabite v obdobju 14 dni.
Seventy-nine (20.1%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Devetinsedemdeset (20,1 %) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %) bolnikov pa glukokortikoide.
SPARCCh MRI Sacroiliac Jointsd,i
SPARCCh MRI sakroiliakalnih sklepov d,i
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22).
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glej preglednico 22).
How to use AMGEVITA
Kako uporabljati zdravilo AMGEVITA
AMGEVITA slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Zdravilo AMGEVITA upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen in izboljšuje telesno delovanje.
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Neklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Step 3: Inject G. Hold the stretch or pinch.
3. korak: Injiciranje G. Držite kožno gubo.
Finger flange Label and expiration date
Oprijemalo za prste Nalepka brizge in rok uporabnosti
Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7%) were in steroid-free quiescence.
Na osnovi pristopa z opaženimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku ≤ 7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
Amongst those who responded at week 16 (n = 144), the paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi »Pediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d Joint Space Narrowing
Ocena erozij Ocena ZSŠd ametotreksat b95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom cna podlagi analize rangov dzožitev sklepne špranje
*P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients b 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
* P < 0,05, ***P < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki 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
Should treatment be interrupted, AMGEVITA 40 mg every week or 80 mg every other week may be re-introduced (see section 5.1).
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom AMGEVITA odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
In controlled and open-label adult and paediatric studies with adalimumab, 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 adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, 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).
Consequently, AMGEVITA can be used during breastfeeding.
Posledično se zdravilo AMGEVITA lahko uporablja med dojenjem.
Put the original package with any unused pre-filled pens back in the refrigerator.
Originalno pakiranje z neuporabljenimi napolnjenimi injekcijskimi peresniki dajte nazaj v hladilnik.
40 mg adalimumab every week
40 mg adalimumaba vsak teden
AMGEVITA can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilo AMGEVITA se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili (NSAID).
No ALT elevations ≥ 3 X ULN occurred in the phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
Figure 3: Kaplan-Meier curves summarising time to treatment failure in the paediatric uveitis study
Slika 3: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
Note: P# = Placebo (number of events/number at risk); A# = Adalimumab (number of events/number at risk).
Opomba: P# = Placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število rizičnih preiskovancev).
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7 ± 6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients < 40 kg (80/40 mg).
Srednje (±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).
● Do not use the pre-filled pen if: - The medicine is cloudy or discoloured, or contains flakes or particles.
● Ne uporabite napolnjenega injekcijskega peresnika, če: - je zdravilo motno ali obarvano ali vsebuje kosmiče ali delce.
AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Zdravilo AMGEVITA je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
Week 2 Week 12 Week 24 ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med adalimumabom in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)