natgillin/translations-raw huggingface dataset:
Alternatively, 50 mg Enbrel administered once weekly has been shown to be safe and effective (see section 5.1).
Druga možnost je dajanje 50 mg enkrat na teden; dokazano je, da je ta možnost varna in učinkovita (glejte poglavje 5. 1).
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg Enbrel administered once weekly.
Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden.
84 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
V primeru ponovnega zdravljenja z zdravilom Enbrel je potrebno upoštevati zgornja navodila glede trajanja zdravljenja.
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
79 Če je indicirano ponovno zdravljenje z zdravilom Enbrel, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
85 Tuberculosis
Tuberkuloza
If active tuberculosis is diagnosed, Enbrel therapy must not be initiated.
80 Če se postavi diagnoza aktivne tuberkuloze, ni dovoljeno uvesti zdravljenja z zdravilom Enbrel.
86 Allergic reactions
Alergijske reakcije
Malignancies and lymphoproliferative disorders
81 Maligne in limfoproliferativne bolezni
In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V nadzorovanih delih kliničnih preskušanj z zaviralci TNF so pri bolnikih, ki so prejemali zaviralec TNF, opazili več primerov limfomov kot pri kontrolni skupini bolnikov.
87 Haematologic reactions
Hematološke reakcije
All patients and parents/ caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e. g. persistent fever, sore throat, bruising, bleeding, paleness) whilst on Enbrel, they should seek immediate medical advice.
Vse bolnike in starše/ skrbnike je treba opozoriti, da morajo v primeru, če se pri bolniku pojavijo znaki in simptomi, ki kažejo na krvno diskrazijo ali okužbo (npr. trdovratna zvišana telesna temperatura, vnetje žrela, podplutbe, krvavitve, bledica), med zdravljenjem s tem zdravilom takoj poiskati zdravniško pomoč.
Long-term studies to assess the safety of the combination are ongoing.
Raziskave za ugotovitev varnosti dolgotrajnega zdravljenja s to kombinacijo zdravil še
88 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.
V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bil dodano zdravilo Enbrel, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično signifikantno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama,
89 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
This experience includes 2 placebo-controlled studies (349 Enbrel patients and 152 placebo patients) and 2 active-controlled trials, one active-controlled trial comparing Enbrel to methotrexate (415 Enbrel patients and 217 methotrexate patients) amd another active-controlled trial comparing Enbrel (223 patients), methotrexate (228 patients) and Enbrel in combination with methotrexate (231 patients).
Dosedanje izkušnje s tem zdravilom vključujejo dve s placebom kontrolirani klinični raziskavi (349 bolnikov, ki so prejemali zdravilo Enbrel, in 152 bolnikov, ki so prejemali placebo), ter dve raziskavi, kontrolirani z zdravilno učinkovino – v eni so zdravilo Enbrel primerjali z metotreksatom (415 bolnikov, ki so prejemali zdravilo Enbrel, in 217 bolnikov, ki so prejemali metotreksat), v drugi pa so primerjali zdravilo Enbrel (223 bolnikov), metotreksat (228 bolnikov) in zdravilo Enbrel v kombinaciji z metotreksatom (231 bolnikov).
In the second active-controlled trial, the rate of discontinuation for adverse events after 2 years of treatment was similar among all three treatment groups, Enbrel (16%), methotrexate (21%) and Enbrel in combination with methotrexate (17%).
V drugem preskušanju, kontroliranem z zdravilno učinkovino, je bil odstotek bolnikov, pri katerih je bilo zdravljenje po 2 letih zdravljenja prekinjeno zaradi neželenih učinkov podoben v vseh treh terapevtskih skupinah; z zdravilom Enbrel( 16%), metotreksatom (21%) in zdravilom Enbrel v kombinaciji z metotreksatom (17%).
In double-blind clinical trials comparing Enbrel to placebo, injection site reactions were the most frequent adverse events among Enbrel-treated patients.
84 V dvojno slepih kliničnih raziskavah, v katerih so zdravilo Enbrel primerjali s placebom, so bile reakcije na mestu injiciranja najpogostejši neželeni učinki pri bolnikih, zdravljenih z zdravilom Enbrel.
Among patients with rheumatoid arthritis treated in placebo-controlled trials, serious adverse events occurred at a frequency of 4% in 349 patients treated with Enbrel compared with 5% of 152 placebo-treated patients.
Pri bolnikih z revmatoidnem artritisom, zdravljenih v s placebom kontroliranih raziskavah, so se pojavili resni neželeni učinki s pogostnostjo 4% pri 349 bolnikih, zdravljenih z zdravilom Enbrel, v primerjavi s 5% od 152 bolnikov, zdravljenih s placebom.
91 Additional information
Dodatne informacije
There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
86 V raziskavah revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, ki so vključevale 5. 966 bolnikov, zdravljenih z zdravilom Enbrel, so zabeležili skupno 15 limfomov.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
O različnih malignih obolenjih (vključno s karcinomom dojke in pljuč ter limfomom) so poročali tudi v obdobju trženja zdravila (glejte poglavje 4. 4).
92 Serious infections
Resne okužbe
In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Po prihodu zdravila na trg je bilo približno pol vseh primerov okužb, opisanih v poročilih o primerih oportunističnih okužb po vsem
93 There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Redko so poročali o bolnikih, vključno z bolniki s pozitivnim revmatoidnim faktorjem, ki so razvili druga avtoprotitelesa v povezavi z lupusu podobnim sindromom ali izpuščaji, ki bi po klinični sliki in bioptičnem izvidu lahko pomenili subakutni kožni lupus ali diskoidni lupus.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/ 139) developed neutropenia (absolute neutrophil count < 1000 / mm 3).
V raziskavah, v katerih so odrasli bolniki sočasno prejemali Enbrel in anakinro, so opažali večjo pogostnost resnih okužb v primerjavi s samim etanerceptom in pri 2% bolnikov (3/ 139) se je pojavila nevtropenija (absolutno število nevtrofilcev < 1. 000/ mm3).
The highest dose level evaluated has been an intravenous loading dose of 32 mg/ m2 followed by subcutaneous doses of 16 mg/ m2 administered twice weekly.
Najvišje ocenjeno odmerjanje je bilo: intravenski udarni odmerek 32 mg/ m2,
There is no known antidote to Enbrel.
Znanega antidota za Enbrel ni.
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic
Zvišano koncentracijo TNF najdemo tudi v sinovijski tekočini in psoriatičnem plaku bolnikov s psoriatičnim artritisom ter v serumu in sinovijski tekočini bolnikov z ankilozirajočim spondilitisom.
94 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih spremembah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Etanercept je kompetitivni zaviralec vezave TNF na receptorje na površini celice in torej zavira biološko aktivnost TNF.
Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
TNF in limfotoksin sta provnetna citokina, ki se vežeta na dva različna tipa receptorjev na površini celice:
TNF and lymphotoxin are pro- inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75- kilodalton (p75) tumour necrosis factor receptors (TNFRs).
55- kilodaltonske (p55) in 75- kilodaltonske (p75) TNF receptorje.
TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
TNF in limfotoksin obstajata pretežno v obliki homotrimerov in njihova biološka aktivnost je odvisna od navzkrižne vezave na TNF receptorje na površini celice.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
V tem poglavju so prikazani podatki iz štirih randomiziranih kontroliranih preskušanj pri odraslih z revmatoidnim artritisom, ene študije pri odraslih s psoriatičnim artritisom, ene študije pri odraslih z ankilozirajočim spondilitisom, ene študije pri otrocih s psoriazo v plakih in štirih študij pri odraslih s psoriazo v plakih.
Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6 respectively; p < 0.01 Enbrel vs placebo at all time points for both ACR 20 and ACR 50 responses).
89 Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom Enbrel, večji kot pri bolnikih, ki so prejemali placebo (ACR 20, po 3 oziroma 6 mesecih: zdravilo Enbrel 62% oziroma 59%, placebo 23% oziroma 11%; ACR 50, po 3 oziroma 6 mesecih: zdravilo Enbrel 41% oziroma 40%, placebo 8% oziroma 5%; p < 0, 01 za zdravilo Enbrel proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3
Vprašalnik za ocenjevanje zdravstvenega stanja HAQ (Health Assessment Questionaire), ki je vključeval invalidnost, vitalnost, duševno zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med raziskavo uporabili vsake 3 mesece.
Continued durable responses have been seen for up to 48 months in open-label extension treatment trials when patients received Enbrel without interruption; longer-term experience is not available.
Dolgotrajna odzivnost na neprekinjeno zdravljenje z zdravilom Enbrel je bila v odprtih podaljšanih kliničnih raziskavah potrjena za obdobja do 48 mesecev; izkušenj z daljšim zdravljenjem še ni.
RADIOGRAPHIC PROGRESSION:
90 RENTGENSKO NAPREDOVANJE:
96 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
V drugi aktivno kontrolirani dvojno slepi randomizirani raziskavi so primerjali klinično učinkovitost, varnost in rentgensko napredovanje pri bolnikih z revmatoidnim artritisom, ki so jih zdravili samo z zdravilom Enbrel (25 mg 2- krat na teden), samo z metotreksatom (7, 5 do 20 mg na teden, mediana 20 mg) ali z zdravilom Enbrel in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediana 5 let) in pri katerih je bil odziv na najmanj eno imunomodulirajoče protirevmatično zdravilo (DMARD) razen metotreksata manj kot zadovoljiv.
Patients in the Enbrel in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Pri bolnikih, ki so prejemali zdravilo Enbrel v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS – » Disease Activity Score «) in HAQ tako po 24 kot po 52 tednih statistično značilno večja kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji tabeli).
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
91 KLINIČNA UČINKOVITOST PO 12 MESECIH:
97 RADIOGRAPHIC PROGRESSION:
92 RENTGENSKO NAPREDOVANJE:
-0.30†
- 1, 0
A single 50 mg/ ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
Ugotovljeno je bilo, da je enkratna 50 mg/ ml injekcija bioekvivalentna dvema hkratnima injekcijama po 25 mg/ ml.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Učinkovitost zdravila Enbrel je bila ocenjena v randomizirani, dvojno slepi in s placebom kontrolirani študiji pri 205 bolnikih s psoriatičnim artritisom.
(1) distal 98 interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
93 (1) distalna interfalangealna prizadetost (DIP - "distal interphalangeal"); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
25 mg odmerki zdravila Enbrel (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba so bili dani subkutano dvakrat na teden v trajanju 6 mesecev.
Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Klinični odzivi so bili izraženi v odstotkih bolnikov, ki so dosegli odziv ACR 20, 50 in 70 in v odstotkih bolnikov z izboljšanjem ocene po kriterijih odzivnosti bolnikov s psoriatičnim artritisom (PsARC – Psoriatic Arthritis Response Criteria).
RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
ODZIVI BOLNIKOV S PSORIATIČNIM ARTRITISOM V S PLACEBOM KONTROLIRANEM PRESKUŠANJU Odstotek bolnikov zdravilo Enbrela Placebo
25 mg Enbrel SC twice weekly b: p  0.001, Enbrel vs. placebo c: p  0.01, Enbrel vs. placebo
25 mg zdravila Enbrel subkutano dvakrat na teden b: p < 0, 001, zdravilo Enbrel v primerjavi s placebom c: p < 0, 01, zdravilo Enbrel v primerjavi s placebom
Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Med bolniki s psoriatičnim artritisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 4. tednih) in so se ohranjali v času 6 mesečne terapije.
Enbrel was significantly better than placebo in all measures of disease activity (p  0.001), and responses were similar with and without concomitant methotrexate therapy.
Zdravilo Enbrel je bilo bistveno boljše kot placebo po vseh kriterijih aktivnosti bolezni (p < 0, 001) in odzivi so bili podobni, ne glede na sočasno zdravljenje z metotreksatom.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p  0.001).
Rezultat indeksa nezmožnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Enbrel, v primerjavi s placebom (p < 0, 001).
47%, respectively, p ≤ .001).
V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz kateregakoli razloga izpadli iz raziskave, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0, 5) po 12 mesecih večji v skupini z zdravilom Enbrel kot v skupini s placebom (73% proti 47%, p ≤ 0, 001).
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
94 POVPREČNA (SE) SPREMEMBA SKUPNE SHARPOVE OCENE OD IZHODIŠČA NA LETO
Enbrel treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Zdravljenje z zdravilom Enbrel je povzročilo izboljšanje telesne funkcije v dvojno slepem obdobju, ta koristni učinek pa se je ohranjal med dolgotrajnejšo izpostavljenostjo, ki je trajala do 2 leti dolgo.
There is insufficient evidence of the efficacy of Enbrel in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Ni zadostnih dokazov za učinkovitost zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in artritisom mutilansom zaradi majhnega števila proučevanih bolnikov.
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of  30 for average of duration and intensity of morning stiffness plus VAS scores of  30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Najširše od teh preskušanj (n=277) je vključevalo bolnike med 18. in 70. letom starosti z aktivnim ankilozirajočim spondilitisom, definiranim po vizualni analogni lestvici (VAS) z vrednostjo ≥ 30 za povprečno trajanje in intenzivnostjo jutranjega šepanja ter VAS vrednost ≥ 30 za vsaj 2 od 3 sledečih parametrov: bolnikova splošna ocena; povprečna VAS vrednost bolečine v hrbtenici ponoči in celokupna bolečina v hrbtenici; povprečno 10 vprašanj v Bath Ankylosing Spondylitis Functional Index (BASFI).
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
138 bolnikov je prejemalo 25 mg odmerke zdravila Enbrel (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba subkutano dvakrat na teden v trajanju 6 mesecev.
The primary measure of efficacy (ASAS 20) was a  20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Po primarnem določanju učinkovitosti (ASAS 20) je prišlo do izboljšanja v ≥ 20% pri vsaj 3 od 4 ocen domen ankilozirajočega spondilitisa (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter brez sprememb v ostalih domenah.
100 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
95 ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANEM PRESKUŠANJU Odstotek bolnikov
Among patients with ankylosing spondylitis who received Enbrel, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Med bolniki z ankilozirajočim spondilitisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev terapije.
101 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Raziskava 1 je bila raziskava 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
96 Raziskava 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot raziskava 1, le da so imeli bolniki ob presejanju indeks PASI vsaj 10.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
ODZIVI BOLNIKOV S PSORIAZO V RAZISKAVAH 2, 3 IN 4
102 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Raziskava 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
97 V raziskavi 3 je večina bolnikov (77%), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila Enbrel po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
Rezultati po 12 tednih pri otrocih s psoriazo v plakih Enbrel 0, 8 mg/ kg enkrat na
103 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 3% of subjects with juvenile idiopathic arthritis.
Pri bolnikih, ki so jih v kliničnih preskušanjih zdravili z etanerceptom v odobrenih odmerkih do 12 mesecev, je bila kumulativna pogostnost protiteles proti etanerceptu približno 6% pri bolnikih z revmatoidnim artritisom, 7, 5% pri bolnikih s psoriatičnim artritisom, 2% pri bolnikih z ankiloznim
After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65  0.66  g/ ml, and the area under the curve was 235  96.6  g hr/ ml.
Po enkratnem subkutanem odmerku 25 mg zdravila Enbrel je bila povprečna največja koncentracija zdravila v serumu pri zdravih prostovoljcih 1, 65 ± 0, 66 μg/ ml, površina pod krivuljo pa 235 ± 96, 6 μg• h/ ml.
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Proporcionalnosti serumskih koncentracij v odvisnosti od odmerka niso formalno preverjali, vendar po v razponu terapevtskih odmerkov ni bilo opaziti nasičenja očistka zdravila.
Mean serum concentration profiles at steady state i. e.
Parametri srednje koncentracije v serumu v stanju dinamičnega ravnovesja pri bolnikih z revmatoidnim artritisom zdravljenih z etanerceptom 50 mg enkrat na teden (n=21) in z etanerceptom 25 mg dvakrat na teden (n=16) so bili primerljivi: