natgillin/translations-raw huggingface dataset:
47 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.
45 Ni zadostnih dokazov za učinkovitost zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in artritisom mutilansom zaradi majhnega števila proučevanih bolnikov.
No study has been performed in patients with psoriatic arthritis using the 50 mg once weekly dosing regimen.
Pri bolnikih s psoriatičnim artritisom klinične študije z režimom odmerjanja 50 mg enkrat na teden niso bile izvedene.
48 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI 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.
46 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.
49 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.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
47 ODZIVI BOLNIKOV S PSORIAZO V RAZISKAVAH 2, 3 IN 4
50 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%.
At week 12, more patients randomised to Enbrel had positive efficacy responses (e. g., PASI 75) than those randomised to placebo.
PASI 75) več bolnikov v skupini z zdravilom Enbrel kot v skupini s placebom.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
48 Rezultati po 12 tednih pri otrocih s psoriazo v plakih Enbrel 0, 8 mg/ kg enkrat na
51 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
49 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 in treated RA patients were Cmax of 2.4 mg/ l vs 2.6 mg/ l, Cmin 1.2 mg/ l vs 1.4 mg/ l and partial AUC of 297 mgh/ l vs 316 mgh/ l for 50 mg Enbrel once weekly (n=21) vs 25 mg Enbrel twice weekly (n=16), respectively.
Pri zdravljenih bolnikih z revmatoidnim artritisom so bili parametri srednje koncentracije v serumu v stanju dinamičnega ravnovesja naslednji: z zdravilom Enbrel 50 mg enkrat na teden (n = 21) so bile Cmax 2, 4 mg/ l, Cmin 1, 2 mg/ l in delna AUC 297 mg. h/ l, z zdravilom Enbrel 25 mg dvakrat na teden (n = 16) pa Cmax 2, 6 mg/ l, Cmin 1, 4 mg/ l in delna AUC 316 mg. h/ l.
52 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
5.3 Preclinical safety data
50 5. 3 Predklinični podatki o varnosti
Mannitol Sucrose Trometamol
Prašek: manitol saharoza trometamol.
Chemical and physical stability has been demonstrated for 48 hours at 2 – 8 C.
Dokazano je bilo, da je pripravljeno zdravilo kemijsko in fizikalno stabilno 48 ur pri temperaturi od 2 °C do 8 °C.
If not used immediately, storage times are the responsibility of the user and should normally not be longer than 6 hours at 2 – 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.
Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Vsaka škatla vsebuje po 4 viale zdravila Enbrel in 8 alkoholnih tamponov.
Instructions for use and handling
51 Navodila za pripravo in ravnanje z zdravilom
The solution should be clear and colourless to pale yellow with no lumps, flakes or particles.
Raztopina mora biti bistra in brezbarvna ali bledo rumene barve in ne sme vsebovati kepic, kosmičev ali delcev.
55 1.
52 1.
56 Polyarticular juvenile idiopathic arthritis
Poliartikularni juvenilni idiopatski artritis
Psoriatic arthritis
53 Psoriatični artritis
57 Plaque psoriasis
Psoriaza v plakih
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
54 V primeru ponovnega zdravljenja z zdravilom Enbrel je potrebno upoštevati zgornja navodila glede trajanja zdravljenja.
58 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In evaluating patients for infections, the patient’ s risk for relevant opportunistic infections (e. g., exposure to endemic mycoses) should be considered.
Pri pregledovanju bolnikov glede okužb moramo upoštevati bolnikovo tveganje za relevantne oportunistične okužbe (npr. izpostavljenost endemičnim mikozam).
Tuberculosis
55 Tuberkuloza
It is recommended that the conduct of these tests should be recorded in the patient’ s alert card.
Priporočljivo je, da se ti testi vpišejo v bolnikovo opozorilno kartico.
Reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus who are receiving TNF-antagonists including Enbrel has been reported.
Poročali so o reaktivaciji virusa hepatitisa B (HBV) pri bolnikih, ki so kronični prenašalci tega virusa in ki so prejemali antagoniste TNF, med drugim tudi Enbrel.
If Enbrel is used in carriers of HBV, the patients should be monitored for signs and symptoms of active HBV infection and, if necessary, appropriate treatment should be initiated.
Če uporabljamo Enbrel pri prenašalcih HBV, moramo bolnike spremljati glede znakov in simptomov aktivne okužbe s HBV, po potrebi pa moramo začeti z ustreznim zdravljenjem.
59 Worsening of hepatitis C
Poslabšanje hepatitisa C
Immunosuppression
56 Imunosupresija
60 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.
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
57 Motnje CŽS
A careful risk/ benefit evaluation, including a neurological assessment, is recommended when prescribing Enbrel to patients with pre-existing or recent onset of CNS demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Pri bolnikih z demielinizirajočimi obolenji CŽS, ki so obstajala že prej ali so se pojavila pred kratkim ali pri tistih, ki imajo povečano tveganje za razvoj demielinizirajoče bolezni, je potrebno pred zdravljenjem z zdravilom Enbrel skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
The long-term safety of Enbrel in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Varnost dolgotrajnega kombiniranega zdravljenja z zdravilom Enbrel in drugimi imunomodulirajočimi protirevmatičnimi zdravili (DMARD – » disease- modifying antirheumatic drugs «) ni bila ugotovljena.
61 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).
58 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).
62 Non-interactions
Medsebojno nedelovanje
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) and another active-controlled trial comparing Enbrel (223 patients), methotrexate (228 patients) and Enbrel in combination with methotrexate (231 patients).
59 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.
Dodatno so zdravilo Enbrel raziskovali še pri 240 bolnikih s psoriatičnim artritisom, ki so sodelovali v 2 dvojno slepih s placebom kontroliranih raziskavah in v podaljšani odprti raziskavi.
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.
63 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 (Enbrel 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%).
64 Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja:
65 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.
67 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.
Tumor Necrosis Factor alpha (TNF-α) inhibitors.
Farmakoterapevtska skupina: zaviralci tumorje nekrotizirajočega faktorja alfa (TNF- α).
68 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).
All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
65 zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med raziskavo uporabili vsake 3 mesece.
Re-introduction of treatment with Enbrel after discontinuations of up to 24 months resulted in the same magnitudes of responses 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 Enbrel prejemali neprekinjeno.
The efficacy of Enbrel was compared to methotrexate in a third randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
V tretji randomizirani aktivno kontrolirani raziskavi s slepo radiografsko oceno kot primarnim opazovanim dogodkom so primerjali učinkovitost zdravila Enbrel z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta), ki se prej niso zdravili z metotreksatom.
70 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).
66 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).
71 RADIOGRAPHIC PROGRESSION:
67 RENTGENSKO NAPREDOVANJE:
-0.23† ,
0, 32
-0.54† ,
- 0, 23 †, φ - 0, 30 † - 0, 5 - 0, 54 †, φ
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or
Bolniki so nadaljevali zdravljenje s
72 intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti- inflammatory drug and/ or prednisone (< 0.2 mg/ kg/ day or 10 mg maximum).
68 stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ ali prednizona (< 0, 2 mg/ kg/ dan ali največ 10 mg).
73 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
69 ODZIVI BOLNIKOV S PSORIATIČNIM ARTRITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI Odstotek bolnikov zdravilo Enbrela Placebo
74 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.
70 Ni zadostnih dokazov za učinkovitost zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in artritisom mutilansom zaradi majhnega števila proučevanih bolnikov.
75 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI 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.
71 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.
The safety and efficacy profiles of the 50 mg once weekly and 25 mg twice weekly regimens were similar.
Profil varnosti in učinkovitosti je bil pri režimu dajanju 50 mg enkrat na teden enak kot pri režimu dajanja 25 mg dvakrat na teden.
Patients who “ failed to respond to” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Skupina bolnikov v ciljni populaciji “ ki se ne odzove ” je opredeljena glede na nezadostni odziv (PASI < 50 ali PGA – Physician Global Assesment - manj kot dober) ali glede na poslabšanje bolezni tekom zdravljenja, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da se je lahko ocenilo odziv.
76 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.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
72 ODZIVI BOLNIKOV S PSORIAZO V RAZISKAVAH 2, 3 IN 4
77 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%.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
73 Rezultati po 12 tednih pri otrocih s psoriazo v plakih Enbrel 0, 8 mg/ kg enkrat na
78 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
74 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 in treated RA patients were Cmax of 2.4 mg/ l vs 2.6 mg/ l, Cmin of 1.2 mg/ l vs 1.4 mg/ l and partial AUC of 297 mgh/ l vs 316 mgh/ l for 50 mg Enbrel once weekly (n=21) vs 25 mg Enbrel twice weekly (n=16), respectively.
Pri zdravljenih bolnikih z revmatoidnim artritisom so bili parametri srednje koncentracije v serumu v stanju dinamičnega ravnovesja naslednji: z zdravilom Enbrel 50 mg enkrat na teden (n = 21) so bile Cmax 2, 4 mg/ l, Cmin 1, 2 mg/ l in delna AUC 297 mg. h/ l, z zdravilom Enbrel 25 mg dvakrat na teden (n = 16) pa Cmax 2, 6 mg/ l, Cmin 1, 4 mg/ l in delna AUC 316 mg. h/ l.
In a population pharmacokinetics analysis in ankylosing spondylitis patients the etanercept steady state AUCs were 466  g hr/ ml and 474  g hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Analize farmakokinetike pri posameznih skupinah bolnikov kažejo, da so bile pri bolnikih z ankilozirajočim spondilitisom pri režimu odmerjanja zdravila Enbrel 50 mg enkrat na teden (N = 154) vrednosti AUC etanercepta v stanju dinamičnega ravnovesja 466 μg* ur/ ml, pri režimu odmerjanja 25 mg dvakrat na teden (N = 148) pa 474 μg* ur/ ml.
79 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
5.3 Preclinical safety data
75 5. 3 Predklinični podatki o varnosti
Cartons contain 4, 8 or 24 vials of Enbrel with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Vsaka škatla vsebuje po 4, 8 ali 24 vial zdravila Enbrel, 4, 8 ali 24 z vehiklom napolnjenih injekcijskih brizg, 4, 8 ali 24 igel, 4, 8 ali 24 adapterjev za viale in 8, 16 ali 48 alkoholnih tamponov.
6.6 Special precautions for disposal and other handling
76 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Some white
V viali lahko ostane nekaj bele pene – to je normalno.
82 1.
77 1.
Enbrel has been shown to improve physical
Zdravljenje aktivnega in progresivnega psoriatičnega artritisa pri odraslih, če je bil odziv na zdravljenje z imunomodulirajočimi protirevmatičnimi zdravili nezadosten.
83 function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Izkazalo se je, da zdravilo Enbrel izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in da upočasni hitrost napredovanja okvar perifernih sklepov, izmerjeno z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Ankylosing spondylitis
78 Ankilozirajoči spondilitis
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis or paediatric plaque psoriasis.
Zdravljenje z zdravilom Enbrel lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, psoriaze v plakih ali otroške psoriaze v plakih.