natgillin/translations-raw huggingface dataset:
If not used immediately, storage times are the responsibility of the user and should normally not be longer that 6 hours at 2 C - 8 C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če se zdravilo ne uporabi takoj, je za čas shranjevanja, ki normalno ne sme presegati 6 ur pri temperaturi od 2 °C do 8 °C, odgovoren uporabnik, razen če je bila priprava zdravila izvedena v kontroliranih in validiranih aseptičnih pogojih.
Store in a refrigerator (2 C – 8 C).
Shranjujte v hladilniku (2 °C – 8 °C).
Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Viala iz prozornega stekla (4 ml, steklo tipa I) z gumijastim zamaškom, aluminijastim obročkom in plastičnim pokrovčkom (tipa "flip- off").
The syringes are type I glass-fitted with stainless steel needles.
Brizge so steklene (steklo tipa I), igle so iz nerjavečega jekla.
Cartons contain 4 vials of Enbrel with 4 pre-filled solvent syringes and 8 alcohol swabs.
Vsaka škatla vsebuje po 4 viale zdravila Enbrel, 4 z vehiklom napolnjene injekcijske brizge in 8 alkoholnih tamponov.
6.6 Special precautions for disposal and other handling
26 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Enbrel is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.
Pred uporabo in subkutanim injiciranjem zdravilo Enbrel raztopite v 1 ml vode za injekcije.
Enbrel contains no antibacterial preservative, and therefore, solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Zdravilo Enbrel ne vsebuje antibakterijskih konzervansov, zato je treba raztopino, pripravljeno z vodo za injekcije, injicirati čimprej oziroma najkasneje v 6- ih urah po pripravi.
Start again with another vial.
Zdravila Enbrel ne smete uporabiti, če se ves prašek v viali ne raztopi v 10 minutah; v tem primeru to vialo zavrzite in vzemite novo.
27 Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Izčrpna navodila za pripravo in aplikacijo pripravljene viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij zdravila Enbrel".
3 February 2000 Date of last renewal:
03. 02. 2000 Datum zadnjega podaljšanja dovoljenja za promet:
3 February 2005
03. 02. 2005
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
29 Polyarticular juvenile idiopathic arthritis
Poliartikularni juvenilni idiopatski artritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate.
28 zdravljenje z imunomodulirajočimi protirevmatičnimi zdravili nezadosten.
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki se ne odzovejo na drugo sistemsko zdravljenje, vključno s ciklosporinom, metotreksatom ali PUVA, oziroma je pri njih drugo zdravljenje kontraindicirano ali ga ne prenašajo (glejte poglavje 5. 1).
Alternatively, 50 mg 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).
30 Plaque psoriasis
Psoriaza v plakih
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.
Elderly patients ( 65 years)
29 Starostniki (≥ 65 let)
31 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Pred zdravljenjem z zdravilom Enbrel, med njim in po njem je treba bolnike pregledati glede okužb in pri tem upoštevati, da je povprečni razpolovni čas odstranjevanja etanercepta iz telesa približno 70 ur (razpon 7 do 300 ur).
Tuberculosis
30 Tuberkuloza
32 Worsening of hepatitis C
Poslabšanje hepatitisa C
Immunosuppression
31 Imunosupresija
The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Za antagonisteTNF, vključno z zdravilom Enbrel, velja, da lahko vplivajo na naravno odpornost bolnika proti okužbam in malignim obolenjem, saj TNF sodeluje pri vnetju in uravnava celični imunski odziv.
33 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.
However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Pojavnost je bila sicer redka, obdobje spremljanja bolnikov, ki so prejemali placebo pa krajše kot pri bolnikih, ki so prejemali zaviralec TNF.
Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
Posebna previdnost je potrebna pri bolnikih, zdravljenih z zdravilom Enbrel, ki imajo krvno diskrazijo v anamnezi.
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 pri bolniku v primeru pojava znakov ali simptomov, 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.
CNS disorders
32 Motnje CŽS
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8) Although no clinical trials have been performed evaluating Enbrel therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Čeprav ni bilo kliničnih raziskav za ovrednotenje terapije z zdravilom Enbrel pri bolnikih z multiplo sklerozo, so klinične raziskave drugih zaviralcev TNF pri teh bolnikih pokazale poslabšanje bolezni.
34 The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Uporaba zdravila Enbrel v kombinaciji z drugimi sistemskimi zdravljenji ali fototerapijo za zdravljenje psoriaze ni raziskana.
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
33 Poleg tega so v dvojno slepem, s placebom kontroliranem preizkušanju pri odraslih bolnikih, ki so prejemali metotreksat, opazili, da so imeli bolniki, zdravljeni z zdravilom Enbrel in anakinro, pogostejše resne okužbe (7%) in nevtropenijo kot bolniki, zdravljeni z zdravilom Enbrel (glejte poglavji 4. 4 in 4. 8).
35 Non-interactions
Medsebojno nedelovanje
Enbrel has been studied in 2,680 patients with rheumatoid arthritis in double-blind and open-label trials.
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
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).
34 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).
Additionally, Enbrel has been studied in240 psoriatic arthritis patients who participated in 2 double-blind placebo- controlled studies and an open-label extension study Five hundred and eight (508) ankylosing spondylitis patients were treated with Enbrel in 4 double-blind placebo-controlled studies.
Petsto osem (508) bolnikov z ankilozirajočim spondilitisom so zdravili z zdravilom Enbrel v 4 dvojno slepih s placebom kontroliranih raziskavah.
Enbrel has also been studied in 1,180 patients with plaque psoriasis for up to 6 months in 4 double-blind placebo-controlled studies.
Zdravilo Enbrel so raziskali tudi pri 1. 180 bolnikih s psoriazo v plakih, in sicer v 4 dvojno slepih, s placebom kontroliranih raziskavah, ki so trajale do 6 mesecev.
36 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.
In the second active-controlled trial the rate of serious adverse events after 2 years of treatment was similar among the three treatment groups (Enbrell 16%, methotrexate 15% and Enbrel in combination with methotrexate 17%).
V drugem preskušanju, kontroliranem z zdravilno učinkovino, je bil odstotek hudih neželenih učinkov po 2 letih zdravljenja podoben v vseh treh terapevtskih skupinah (zdravilo Enbrel 16%, metotreksat 15% in zdravilo Enbrel v kombinaciji z metotreksatom 17%).
Among patients with plaque psoriasis treated in placebo-controlled trials, the frequency of serious adverse events was about 1.2% of 1,029 patients treated with Enbrel compared with 1.5% of 460 placebo-treated patients.
Med bolniki s psoriazo v plakih, zdravljenimi v raziskavah, kontroliranih s placebom, je znašala pogostnost resnih neželenih učinkov približno 1, 2% od 1. 029 bolnikov, zdravljenih z zdravilom Enbrel, in 1, 5% od 460 bolnikov, ki so dobivali placebo.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000); not known (could not be accurately estimated through clinical studies).
Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje pojav učinka), z uporabo naslednjih kategorij: zelo pogosti (> 1/ 10); pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100); redki (> 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000); neznana (ni mogoče natančno oceniti s pomočjo kliničnih študij).
Thrombocytopenia Anaemia, leukopenia, neutropenia, pancytopenia* Aplastic anaemia*
trombocitopenija anemija, levkopenija, nevtropenija, pancitopenija * aplastična anemija *
37 Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja:
Among rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis patients in placebo-controlled, active-controlled, and open-label trials of Enbrel, serious adverse events reported included malignancies (see below), asthma, infections (see below), heart failure, myocardial infarction, myocardial ischaemia, chest pain, syncope, cerebral ischaemia, hypertension, hypotension, cholecystitis, pancreatitis, gastrointestinal haemorrhage, bursitis, confusion, depression, dyspnoea, abnormal healing, renal insufficiency, kidney calculus, deep vein thrombosis, pulmonary embolism, membranous glomerulonephropathy, polymyositis, thrombophlebitis, liver damage, leucopenia, paresis, paresthesia, vertigo, allergic alveolitis, angioedema, scleritis, bone fracture, lymphadenopathy, ulcerative colitis, intestinal obstruction, eosinophilia, haematuria, and sarcoidosis.
Pri bolnikih z revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in psoriazo v plakih so v s placebom kontroliranih raziskavah, z aktivno učinkovino kontroliranih raziskavah in odprtih raziskavah poročali o resnih neželenih učinkih, vključno z malignimi obolenji (glejte spodaj), astmo, okužbami (glejte spodaj), srčnim popuščanjem, miokardnim infarktom, miokardno ishemijo, bolečinami v prsnem košu, sinkopo, cerebralno ishemijo, hipertenzijo, hipotenzijo, holecistitisom, pankreatitisom, gastrointestinalnimi krvavitvami, burzitisom, zmedenostjo, depresijo, dispnejo, nenormalnim celjenjem ran, ledvično insuficienco, ledvičnimi kamni, globoko vensko trombozo, pljučno embolijo, membransko glomerulonefropatijo, polimiozitisom,
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
V raziskavah pri 351 bolnikih z ankilozirajočim spondilitisom, ki so trajale več kot 2 leti, so poročali o 6 primerih malignega obolenja pri bolnikih, ki so prejemali Enbrel.
38 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.
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.
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Resne okužbe so se pojavile pri 6, 3% bolnikov z revmatoidnim artritisom, ki so prejemali Enbrel do 48 mesecev dolgo.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Med temi resnimi okužbami so bili abscesi (na različnih mestih), bakteriemija, bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis, pljučnica, pielonefritis, sepsa, septični artritis, sinuzitis, okužbe kože, kožne razjede, okužbe sečil, vaskulitis in okužbe ran.
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Med resnimi okužbami pri bolnikih, zdravljenih z zdravilom Enbrel, so bile flegmona, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni
In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
V dvojno slepih in odprtih preskušanjih psoriatičnega artritisa je 1 bolnik poročal o resni okužbi (pljučnici).
The exposure-adjusted rate was 0.06 events per 100 patient-years.
Za izpostavljenost popravljena pogostnost je bila 0, 06 dogodka na 100 bolniških let.
In postmarketing experience, approximately half of all of the case reports of opportunistic infections
Po prihodu zdravila na trg je bilo približno pol vseh primerov okužb, opisanih v poročilih o primerih oportunističnih okužb po vsem svetu, invazivnih glivičnih okužb.
There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4)
Po prihodu zdravila Enbrel na tržišče so poročali o pancitopeniji in aplastični anemiji, nekateri od teh primerov so bili tudi smrtni (glejte poglavje 4. 4).
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 / mm3).
V raziskavah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo pogostnost resnih okužb v primerjavi s samim etanerceptom in pri 2% bolnikov (3/ 139) se je
40 The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Vrste okužb, ki so jih opazili v kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom, starih od 2 do 18 let, so bile na splošno blage do zmerne in skladne s tistimi, ki jih pogosto vidimo pri skupinah ambulantnih pediatričnih bolnikov.
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, nato pa 16 mg/ m2 2- krat tedensko subkutano.
One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Nek bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg zdravila Enbrel 2- krat tedensko 3 tedne, ne da bi pri tem prišlo do kakršnega koli neželenega učinka.
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Zvišano koncentracijo TNF najdemo tudi v sinovijski tekočini in psoriatičnem plaku bolnikov s psoriatičnim artritisom ter v serumu in sinovijski tekočini bolnikov z ankilozirajočim
41 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.
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).
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 months during the trial.
Vprašalnik za ocenjevanje zdravstvenega stanja HAQ (Health Assessment Questionaire), ki je vključeval invalidnost, vitalnost, duševno
All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
40 zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med raziskavo uporabili vsake 3 mesece.
After discontinuation of Enbrel, syptoms of arthritis generally returned within a month.
Po prekinitvi zdravljenja z zdravilom Enbrel so se simptomi artritisa največkrat ponovno pojavili že v prvem mesecu.
Re-introduction of treatment with Enbrel after discontinuations of up to 24 months resulted in the same magnitudes of response as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Po podatkih iz odprtih raziskav je bila odzivnost na ponovno zdravljenje z zdravilom Enbrel po do 24 mesecev trajajoči prekinitvi enaka odzivnosti pri bolnikih, ki so zdravilo Enbrel prejemali neprekinjeno.
RADIOGRAPHIC PROGRESSION:
RENTGENSKO NAPREDOVANJE:
COMPARISON OF ENBREL vs METHOTREXATE IN PATIENTS WITH RA OF < 3 YEARS
PRIMERJAVA ZDRAVILA ENBREL Z METOTRAKSATOM PRI BOLNIKIH Z REVMATOIDNIM ARTRITISOM (TRAJANJE BOLEZNI MANJ KOT 3 LETA)
Change from Baseline
Sprememba v primerjavi
12 Months 2.5
12 mesecev
43 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).
41 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:
KLINIČNA UČINKOVITOST PO 12 MESECIH:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION Enbrel +
PRIMERJAVA MED ZDRAVILOM ENBREL, METOTRAKSATOM IN KOMBINACIJO ZDRAVILA ENBREL IN METOTREKSATA PRI BOLNIKIH Z REVMATOIDNIM ARTRITISOM (TRAJANJE BOLEZNI OD 6 MESECEV DO 20 LET) zdravilo Enbrel +
Patients who did not complete 12 months in the study were considered to be non- responders. b:
Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni. b:
Values for DAS are means. c:
Vrednosti za oceno stopnje bolezni (DAS - Disease Activity Score) so povprečne vrednosti. c:
44 RADIOGRAPHIC PROGRESSION:
42 RENTGENSKO NAPREDOVANJE:
The safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Varnost in učinkovitost 50 mg zdravila Enbrel (dve subkutani injekciji po 25 mg) enkrat na teden so ocenili v dvojno slepi, s placebom kontrolirani raziskavi pri 420 bolnikih z aktivnim revmatoidnim artritisom.
45 inflammatory drug and/ or prednisone (< 0.2 mg/ kg/ day or 10 mg maximum).
43 stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ ali prednizona (< 0, 2 mg/ kg/ dan ali največ 10 mg).
Doses of 25 mg 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 raziskave za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba so bili dani subkutano dvakrat na teden v trajanju 6 mesecev.
46 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
44 ODZIVI BOLNIKOV S PSORIATIČNIM ARTRITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI Odstotek bolnikov zdravilo Enbrela Placebo