natgillin/translations-raw huggingface dataset:
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.
Tarča adalimumaba je beljakovina ki se imenuje tumorje nekrotizirajoči faktor (TNFα), ki je vključen v imunski (obrambni) sistem in je prisoten v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
Very common Injection site reaction (including injection site erythema) Common
zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranje)
Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines.
Bolniki, ki prejemajo zdravilo AMGEVITA, lahko sočasno dobijo cepiva, razen živih cepiv.
Should treatment be interrupted, AMGEVITA may be re-introduced as appropriate.
Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom AMGEVITA znova uvesti, kakor je primerno.
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 leukaemia (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).
By attaching to TNFα, AMGEVITA decreases the process of inflammation in these diseases.
Z vezavo na TNFα zdravilo AMGEVITA zmanjša vnetni proces pri teh boleznih.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana uporaba.
- Do not inject into areas where the skin is tender, bruised, red, or hard.
- Ne injicirajte v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
What you need to know before you use AMGEVITA
Kaj morate vedeti, preden boste uporabili zdravilo AMGEVITA
Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Adalimumab je pokazal terapevtsko korist pri bolnikih s psoriazo nohtov z različnim obsegom prizadetosti kože (telesna površina ≥ 10 % (60 % bolnikov) in telesna površina < 10 % in ≥ 5 % (40 % bolnikov)).
Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
Excipients with known effects
Pomožne snovi z znanim učinkom
• angioedema (localised swelling of the skin);
• angioedem (lokalizirano otekanje kože);
Thus additional caution should be exercised in considering AMGEVITA treatment of these patients (see section 4.8).
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom AMGEVITA pri teh bolnikih (glejte poglavje 4.8).
- The pre-filled pen has been dropped on a hard surface.
- vam je napolnjeni injekcijski peresnik padel na trdo površino.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given (see section 4.8).
Če se bolniku po zdravljenju z zdravilom AMGEVITA pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom AMGEVITA ne sme nadaljevati (glejte poglavje 4.8).
Adverse Reaction unspecified (including cysts and polyps)*
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)*
Patients who had been randomised to placebo in Period A were assigned to receive placebo in Period B.
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdovju B prejemali placebo.
Therefore, the combination of AMGEVITA and anakinra is not recommended (see section 4.5).
Zato kombinacija zdravila AMGEVITA in anakinre ni priporočljiva (glejte poglavje 4.5).
● Belly, except for a 2 inch (5 centimetres) area around your belly button
● Stegno ● Trebuh, razen 5 centimetrov v okolici popka
Patients participating in all phase 2 and phase 3 psoriasis studies were eligible to enrol into an openlabel extension trial, where adalimumab was given for at least an additional 108 weeks.
Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili lahko vključeni v odprto podaljšano preskušanje, v katerem so adalimumab prejemali vsaj še dodatnih 108 tednov.
What AMGEVITA is and what it is used for What you need to know before you use AMGEVITA How to use AMGEVITA
Kaj je zdravilo AMGEVITA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo AMGEVITA Kako uporabljati zdravilo AMGEVITA Možni neželeni učinki
What AMGEVITA is and what it is used for
Kaj je zdravilo AMGEVITA in za kaj ga uporabljamo
PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 µg/ml (95 % IZ 0,4-47,6 in 1,9-10,5).
• Merkel cell carcinoma (a type of skin cancer);
• karcinom Merkelovih celic (tip kožnega raka);
If an anaphylactic reaction or other serious allergic reaction occurs, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila AMGEVITA nemudoma prekiniti in uvesti ustrezno zdravljenje.
If you accidentally inject AMGEVITA more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more.
Če pomotoma injicirate zdravilo AMGEVITA pogosteje, kot vam je naročil zdravnik ali farmacevt, se posvetujte z njim ali s farmacevtom in mu povejte, da ste uporabili večji odmerek.
Patients treated with AMGEVITA should be given the Patient Reminder Card.
Bolniki, ki se zdravijo z zdravilom AMGEVITA, morajo dobiti posebno opozorilno kartico za bolnika.
If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Če se vam med zdravljenjem ali po njem pojavijo nove spremembe na koži, ali če se vam spremeni videz obstoječih sprememb, morate to povedati zdravniku.
In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 17 and 18).
V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using AMGEVITA.
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila AMGEVITA.
Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more.
Adalimumab so raziskali pri 9506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
Maintenance of clinical remission and response (percent of patients)
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
• Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
• otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
D. Prepare and clean your injection site(s).
D. Pripravite in očistite mesto injiciranj(a).
Taking these results into consideration, adalimumab 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 adalimumab priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS < 1,3).
Single use only.
Za enkratno uporabo.
Patients should be tested for HBV infection before initiating treatment with AMGEVITA.
Bolnike je treba pred začetkom zdravljenja z zdravilom AMGEVITA testirati na okužbo s HBV.
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 adalimumab 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 adalimumab, in 5,4 % v kontrolni skupini.
Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see figure 2).
V obeh študijah je bil dokazan zgodnji in vzdrževan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
P value1
P vrednost1
~10s
~10 sek
Before you use an AMGEVITA pre-filled syringe, read this important information:
Pred uporabo napolnjene injekcijske brizge zdravila AMGEVITA preberite te pomembne informacije:
In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient-years during an adalimumab trial in paediatric patients with Crohn's disease.
Poleg tega niso opazili nobenega malignoma tudi pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikov-let med študijami z adalimumabom pri pediatričnih bolnikih s Crohnovo boleznijo.
14 weeks a Paediatric ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
14 tednov a Odzivi »Pediatric 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
AMGEVITA may have a minor influence on your ability to drive, cycle or use machines.
Zdravilo AMGEVITA ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja s stroji.
Put the original package with any unused syringes back in the refrigerator.
Originalno pakiranje z neuporabljenimi brizgami dajte nazaj v hladilnik.
Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation.
Bolnike, pri katerih se med zdravljenjem z zdravilom AMGEVITA pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o manj hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQI - Dermatology Life Quality Index).
SPARCC MRI Spined,j a Assessment of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
SPARCC MRI hrbtenjačed,j a ASAS = ocena v spondiloartritičnem mednarodnem združenju (Assessments in Spondyloarthritis International Society) b BASDAI = Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index) c ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score) d povprečna sprememba od začetka zdravljenja e n=91 placebo in n=87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g n=73 placebo in n=70 adalimumab h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research Consortium of Canada) i n=84 placebo in adalimumab j n=82 placebo in n=85 adalimumab ***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Zdravilo AMGEVITA se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih, starejših od 12 let.
During treatment with AMGEVITA, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Med zdravljenjem z zdravilom AMGEVITA je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
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).
How to store AMGEVITA Contents of the pack and other information
Shranjevanje zdravila AMGEVITA Vsebina pakiranja in dodatne informacije
All patients received a 2 week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Vsi bolniki so ob začetku študije prejeli 2-tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
Antibiotics may be continued during treatment with AMGEVITA if necessary.
Med zdravljenjem z zdravilom AMGEVITA lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
Efficacy Outcomes
Rezultati učinkovitosti
● Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
● Ne poskušajte ogrevati napolnjenega injekcijskega peresnika z virom toplote, kot na primer z vročo vodo ali v mikrovalovni pečici.
● Do not use the syringe if: - The medicine is cloudy or discoloured or contains flakes, or particles.
● Ne uporabite brizge, če: - Je zdravilo motno ali obarvano ali vsebuje kosmiče ali delce.
Response, remission and mucosal healing in study UC-II (percent of patients)
Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week
Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Delež bolnikova, ki so dosegli klinični odziv (HiSCR)b v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu
Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.
Brizgo, ki ste ji odstranili pokrovček z igle, zabodite z iglo v kožo pod kotom 45 do 90 stopinj.
Adalimumab-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 adalimumab, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisuAnkylosing Spondylitis Quality of Life Questionnaire).
These infections have not consistently been recognised in patients taking TNFantagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšne okužbe se pri uporabnikih antagonistov TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Zdravilo AMGEVITA je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 29).
Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Izboljšanje v številu aktivnih sklepov z artritisom se je ohranilo v obdobju odprtega preskušanja po 156. tednu pri 26 od 31 (84 %) bolnikov, ki so prejemali adalimumab in so ostali v študiji.
If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo AMGEVITA, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
- The expiration date printed on the label has passed.
- je že pretekel datum roka izteka uporabnosti, ki je naveden na nalepki.
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% versus 13.9%, respectively).
Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjevi s tistimi, ki so bili v skupini z adalimumabom, je v prvih 12. tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
Number of patients at baseline n (%)
Izhodiščno število bolnikov n (%)
Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Z adalimumabom niso bile narejene niti raziskave kancerogenosti, niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodalskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodalcih.
Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% versus 9% respectively, p = 0.031) and study UC-II (17% versus 9% respectively, p = 0.019).
Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
AMGEVITA should only be used during pregnancy if clearly needed.
Zdravilo AMGEVITA se med nosečnostjo lahko uporablja samo, če je brez dvoma potrebno.
ASDAS Inactive Disease hs-CRPd,f,g
ASDAS neaktivna bolezen hs-CRP
No clinical data are available on the use of a AMGEVITA loading dose in children < 6 years of age (see section 5.2).
Klinični podatki o uporabi polnilnega odmerka zdravila AMGEVITA pri otrocih, mlajših od 6 let, niso na voljo (glejte poglavje 5.2).
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 AMGEVITA 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 AMGEVITA.
For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting.
Da bo injiciranje bolj udobno, pustite brizgo za 15 do 30 minut na sobni temperaturi, preden začnete z injiciranjem.
L. Examine the injection site.
L. Preglejte mesto injiciranja.
● Do not reuse the used syringe.
● Uporabljene brizge ne uporabite ponovno.
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose or standard dose maintenance regimens as shown in table 25.
V 4.tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
Amongst those who responded (paediatric ACR 30) at week 24 (n = 27 out of 30 patients), the paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
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.
Improved physical function continued during the open-label extension up to week 136.
Izboljšanje telesnega delovanja je trajalo še med odprto nadaljevalno študijo do 136. tedna.
In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Med obdobjem trženja so bili opisani primeri levkemije pri bolnikih, zdravljenih z antagonistom TNF.
● Do not touch this area again before injecting.
● Tega predela se pred injiciranjem ne dotikajte več.
Standard dose
Standarden odmerek