natgillin/translations-raw huggingface dataset:
In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
V dveletnem kontroliranem kliničnem preskušanju pri bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z zdravilom Enbrel in metotreksatom nobenih nepričakovanih ugotovitev glede varnosti; varnostni profil zdravila Enbrel pri kombiniranem zdravljenju z metotreksatom je bil podoben varnostnemu profilu, ki je bil ugotovljen pri monoterapiji z zdravilom Enbrel oziroma metotreksatom.
Long-term studies to assess the safety of the combination are ongoing.
Raziskave za ugotovitev varnosti dolgotrajnega zdravljenja s to kombinacijo zdravil še potekajo.
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.
7 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.
Based on pharmacokinetic data (see section 5.2), no dosage adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Klinične izkušnje pri teh bolnikih so omejene.
Physicians should use caution when using Enbrel in patients who have congestive heart failure (CHF).
Zdravniki morajo biti previdni, kadar predpišejo zdravilo Enbrel bolnikom s kongestivnim srčnim popuščanjem (CHF – » congestive heart failure «).
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
Obstajajo postmarketinška poročila o poslabšanju KSP pri bolnikih, ki jemljejo zdravilo Enbrel, v prisotnosti dejavnikov, ki bi lahko sprožili takšno poslabšanje in brez takšnih dejavnikov.
Two large clinical trials evaluating the use of Enbrel in the treatment of CHF were terminated early due to lack of efficacy.
Dve veliki klinični raziskavi za ovrednotenje uporabe zdravila Enbrel pri zdravljenju KSP sta bili predčasno prekinjeni zaradi slabe učinkovitosti zdravila.
Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Enbrel treatment.
Izsledki sicer še niso dokončni, vendar podatki iz ene od teh raziskav kažejo na morebitno tendenco k poslabšanju KSP pri bolnikih, zdravljenih s tem zdravilom.
A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener’ s granulomatosis.
S placebom kontrolirana raziskava, v kateri je 89 odraslih bolnikov poleg standardnega zdravljenja (vključno s ciklofosfamidom ali metotreksatom in glukokortikoidi) jemalo zdravilo Enbrel s srednjim časom zdravljenja 25 mesecev, ni pokazala učinkovitosti zdravila Enbrel za zdravljenje Wegenerjeve granulomatoze.
The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.
Pojavnost nekožnih malignih obolenj različnih tipov je bila znatno večja pri bolnikih, zdravljenih z zdravilom Enbrel, kot pri tistih v kontrolni skupini.
Enbrel is not recommended for the treatment of Wegener’ s granulomatosis.
Zdravila Enbrel ni priporočljivo uporabljati za zdravljenje Wegenerjeve granulomatoze.
4.5 Interaction with other medicinal products and other forms of interaction
7 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Pri odraslih bolnikih, zdravljenih z zdravilom Enbrel in anakinro, so opazili pogostnejše okužbe kot pri bolnikih, zdravljenih bodisi samo z zdravilom Enbrel bodisi samo z anakinro (retrospektivni podatki).
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).
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).
The combination Enbrel and anakinra has not demonstrated increased clinical benefit and is therefore not recommended.
Ni dokazano, da bi bila kombinacija zdravila Enbrel in anakinre klinično koristnejša, zato je ne priporočajo.
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.4).
Za to kombinacijo zvečana klinična koristnost ni dokazana, zato njena uporaba ni priporočljiva (glejte poglavje 4. 4).
Concurrent Enbrel and sulfasalazine treatment
Sočasno zdravljenje z zdravilom Enbrel in sulfasalazinom
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 bilo dodano zdravilo Enbrel, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično signifikantno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z zdravilom Enbrel ali samo s sulfasalazinom.
8 Non-interactions
Medsebojno nedelovanje
See section 4.4 for vaccination advice.
Glejte poglavje 4. 4 za nasvete o cepljenju.
No clinically significant pharmacokinetic drug-drug interactions were observed in studies with digoxin or warfarin.
V študijah z digoksinom ali varfarinom niso opazili nikakršnih klinično pomembnih farmakokinetičnih interakcij med zdravili.
There are no studies of Enbrel in pregnant women.
Kliničnih raziskav o uporabi zdravila Enbrel med nosečnostjo ni.
Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.
Raziskave razvojne toksičnosti pri podganah in kuncih niso pokazale nobenih znakov, da bi etanercept škodljivo učinkoval na zarodke ali novorojene podgane.
Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
Ni predkliničnih podatkov o peri - in postnatalni toksičnosti etanercepta in o učinkih etanercepta na plodnost in splošne reprodukcijske sposobnosti.
Thus, the use of Enbrel in pregnant women is not recommended, and women of child-bearing potential should be advised not to get pregnant during Enbrel therapy.
Ženskam v rodni dobi je treba svetovati, da med zdravljenjem z zdravilom Enbrel ne smejo zanositi.
It is not known whether etanercept is excreted in human milk.
Ni znano ali se etanercept izloča v materino mleko pri človeku.
Following subcutaneous administration to lactacting rats, etanercept was excreted in the milk and detected in the serum of pups.
Po subkutanem dajanju doječim podganam se je etanercept izločal z mlekom in so ga odkrili v serumu mladičev.
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue Enbrel while breast-feeding.
Ker se imunoglobulini, tako kot mnoga druga zdravila, lahko izločajo v mleko pri človeku, se je potrebno odločiti, če bo med zdravljenjem bolnica prenehala dojiti oziroma bo med dojenjem prekinila zdravljenje s tem zdravilom.
4.8 Undesirable effects
8 4. 8 Neželeni učinki
Enbrel has been studied in 2,680 patients with rheumatoid arthritis in double-blind and open-label trials.
Zdravilo Enbrel so klinično preskušali pri 2. 680 bolnikih z revmatoidnim artritisom v dvojno slepih odprtih raziskavah.
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).
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).
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
V prvem z zdravilno učinkovino kontroliranem preskušanju je bilo število bolnikov, ki so izpadli iz preskušanja, statistično značilno večje za metotreksat (10%) kot za zdravilo Enbrel (5%).
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%).
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 študijah.
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.
Among patients with rheumatoid arthritis treated in
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.
9 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 first active-controlled trial, serious adverse events occurred at a frequency of 6% in 415 patients treated with Enbrel compared with 8% of 217 methotrexate-treated patients.
V prvi raziskavi, kontrolirani z aktivno učinkovino, so se pojavili resni neželeni učinki s pogostnostjo 6% pri 415 bolnikih, zdravljenih z zdravilom Enbrel, v primerjavi z 8% od 217 bolnikov, zdravljenih z metotreksatom.
In the second active-controlled trial the rate of serious adverse events after 2 years 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%).
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.
The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Spodnji seznam neželenih učinkov temelji na izkušnjah iz kliničnih raziskav pri odraslih ter na izkušnjah po prihodu zdravila Enbrel na tržišče.
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).
Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)* Uncommon:
okužbe (vključno z okužbami zgornjih dihal, bronhitisom, cistitisom in kožnimi okužbami) *
Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis)* Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial and atypical mycobacterial infections)*
resne okužbe (vključno s pljučnico, celulitisom, septičnim artritisom, sepso) * tuberkuloza, oportunistične okužbe (vključno z invazivnimi glivičnimi, protozojskimi, bakterijskimi in atipičnimi mikobakterijskimi okužbami) *
Thrombocytopenia Anaemia, leukopenia, neutropenia, pancytopenia* Aplastic anaemia*
anemija, levkopenija, nevtropenija, pancitopenija * aplastična anemija *
Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation* Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm) Macrophage activation syndrome*, anti-neutrophilic cytoplasmic antibody positive vasculitis
sindrom aktivacije makrofagov *, vaskulitis s pozitivnimi antinevtrofilnimi citoplazemskimi protitelesi
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
epileptični napadi demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo ali lokalizirana demielinizirajoča stanja, kot je npr. optični nevritis in transverzni mielitis (glejte poglavje 4. 4)
Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
intersticijska bolezen pljuč (vključno s pnevmonitisom in pljučno fibrozo) *
10 Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja:
Pruritus Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
pruritus angioedem, urtikarija, izpuščaj, psoriaziformen izpuščaj, psoriaza (vključno s takšno, ki se začne na novo, in pustularno, predvsem na dlaneh & podplatih)
Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme
kutani vaskulitis (vključno z levkocitoklastičnim vaskulitisom), Stevens- Johnsonov sindrom, erythema multiforme
Subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome
subakutni kožni eritematozni lupus, diskoidni eritematozni lupus, lupusu podoben sindrom
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Common:
reakcije na mestu injiciranja (vključno s krvavitvijo, podplutbami, eritemom, srbenjem, bolečino in oteklino) *
Fever
Pogosti:
There have been reports of worsening of congestive heart failure (see section 4.4).
Poročali so o poslabšanju kongestivnega srčnega popuščanja (glejte poglavje 4. 4)
*see Additional information, below.
* glejte Dodatne informacije v nadaljevanju
Additional information
10 Dodatne informacije
Serious adverse events reported in clinical trials
Resni neželeni učinki iz kliničnih preskušanj
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, tromboflebitisom, okvaro jeter, levkopenijo, parezo, parestezijo, vrtoglavico, alergijskim alveolitisom, angioedemom, skleritisom, zlomi kosti, limfoadenopatijo, ulceroznim kolitisom, intestinalnimi obstrukcijami, eozinofilijo, hematurijo in sarkoidozo.
One hundred and twenty-nine new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
129 različnih tipov novih malignih obolenj so ugotovili pri 4. 114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih raziskavah z zdravilom Enbrel do približno 6 let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila Enbrel in metotreksata v dvoletni aktivno kontrolirani raziskavi.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Ugotovljeni odstotki in incidence v teh kliničnih raziskavah so bili podobni tistim, ki so jih pričakovali za raziskovano populacijo.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
V kliničnih raziskavah z zdravilom Enbrel, ki so trajale približno 2 leti in vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
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 zdravilo Enbrel.
Twenty-three malignancies were reported in plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 15 months involving 1,261 Enbrel-treated patients.
V dvojno slepih in odprtih raziskavah, ki so trajale do 15 mesecev in so zajele 1. 261 bolnikov, zdravljenih z zdravilom Enbrel, so med bolniki s psoriazo v plakih, zdravljenimi z zdravilom Enbrel, zabeležili 23 malignomov.
11 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.
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
Poročila o različnih malignih obolenjih (vključno z rakom dojke in pljuč ter limfomi) smo prejeli tudi v obdobju po prihodu zdravila Enbrel na tržišče (glejte poglavje 4. 4).
Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs.
V primerjavi s placebom je bila pri bolnikih z revmatskimi obolenji, zdravljenih z zdravilom Enbrel, statistično značilno večja incidenca reakcij na mestu injiciranja (36% proti 9%).
Injection site reactions usually occurred in the first month.
Reakcije na mestu injiciranja so se navadno pojavljale v prvem mesecu.
No treatment was given for the majority of injection site reactions in the Enbrel treatment groups, and the majority of patients who were given treatment received topical preparations such as corticosteroids, or oral antihistamines.
Večina bolnikov, pri katerih je bilo zdravljenje le potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide ali peroralne antihistaminike.
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection along with the simultaneous appearance of injection site reactions at previous injection sites.
Nekateri bolniki so dobili tako imenovano spominsko lokalno reakcijo na mestu injiciranja; ob naslednjem injiciranju se je poleg reakcije na tedanjem mestu injiciranja sočasno pojavila reakcija tudi na prejšnjih mestih injiciranja.
These reactions were generally transient and did not recur with treatment.
Te reakcije so bile običajno prehodne in se niso ponavljale med zdravljenjem.
In controlled trials in patients with plaque psoriasis, approximately 14.5% of patients treated with Enbrel developed injection site reactions compared with 5.2% of placebo-treated patients during the first 12 weeks of treatment.
V kontroliranih raziskavah bolnikov s psoriazo v plakih so se reakcije na mestu injiciranja v prvih 12 tednih zdravljenja pojavile pri približno 14, 5% bolnikov, zdravljenih z zdravilom Enbrel, in pri 5, 2% bolnikov, ki so dobivali placebo.