natgillin/translations-raw huggingface dataset:
There were no differences in rates of infection among patients treated with Enbrel and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
V stopnjah pogostnosti okužb med bolniki, zdravljenimi z zdravilom Enbrel, in tistimi, ki so prejemali placebo za zdravljenje psoriaze v plakih, v preskušanjih, nadzorovanih s placebom, ki so trajala do 24 tednov, ni bilo razlik.
In adults (aged 18 and over), Enbrel can be used for moderate or severe rheumatoid arthritis, psoriatic arthritis, severe axial spondyloarthritis including ankylosing spondylitis, and moderate or severe psoriasis - in each case usually when other widely used treatments have not worked well enough or are not suitable for you.
Pri odraslih (starih 18 let in več) se zdravilo Enbrel lahko uporablja pri zdravljenju zmernega ali hudega revmatoidnega artritisa, psoriatičnega artritisa, hudega aksialnega spondilartritisa, vključno z ankilozirajočim spondilitisom, in zmerne ali hude luskavice - v vseh primerih običajno šele po neuspešnem zdravljenju z drugimi običajnimi oblikami zdravljenja, ali če te oblike zdravljenja za vas niso primerne.
You or the child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Zdravila Enbrel vi ali otrok ne smete jemati skupaj z zdravili, ki vsebujejo učinkovino anakinro ali abatacept.
If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Enbrel.
Če imate kakršnakoli vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, ki dobro poznajo zdravilo Enbrel.
Withdrawing the Enbrel solution from the vial f.
Jemanje raztopine zdravila Enbrel iz viale f.
Adjusted mean change from baseline was 3.8 for Enbrel treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Prilagojena povprečna sprememba od izhodišča je bila 3,8 pri bolnikih, zdravljenih z zdravilom Enbrel (n = 95), in 0,8 pri bolnikih, ki so prejemali placebo (n = 105) (p < 0,001).
How to use Enbrel
Kako uporabljati zdravilo Enbrel
Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis.
Pri združevanju rezultatov nadzorovanih kliničnih preskušanj so opazili več primerov NMSC pri bolnikih, ki so prejemali zdravilo Enbrel, kot pri kontrolnih bolnikih, še zlasti pri bolnikih s psoriazo.
Do not insert the needle at an angle, this may cause the needle to bend and/or prevent proper addition of the solvent into the vial (see Diagram 4).
Igle ne zabodite pod kotom, ker bi jo lahko tako ukrivili in/ali s tem preprečili pravilno dovajanje vehikla v vialo (glejte sliko 4).
Your doctor will decide how long you should take Enbrel and whether retreatment is needed based on your response.
Zdravnik bo na podlagi vašega odziva na zdravilo določil, koliko časa morate uporabljati zdravilo Enbrel in ali je potrebno ponovno zdravljenje.
Enbrel powder for solution must be reconstituted in 1 ml of solvent before use (see section 6.6).
Pred uporabo je treba Enbrel prašek za raztopino za injiciranje rekonstituirati v 1 ml vehikla (glejte poglavje 6.6).
There is no known antidote to Enbrel.
Znanega antidota za zdravilo Enbrel ni.
One hundred and twenty-nine (129) 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.
Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z zdravilom Enbrel do približno 6 let, vključno z 231 bolniki, ki so bili zdravljeni s kombinacijo zdravila Enbrel in metotreksata v dvoletni študiji, nadzorovani z učinkovino.
Enbrel should be discarded if not used within four weeks after removal from the refrigerator.
Zdravilo Enbrel zavrzite, če ga ne porabite v štirih tednih po odvzemu iz hladilnika.
Enbrel (n = 223)
zdravilo Enbrel (n = 223)
In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
V nadzorovanih preskušanjih bolnikov s psoriazo v plakih so se reakcije na mestu injiciranja v prvih 12 tednih zdravljenja pojavile pri približno 13,6 % bolnikov, zdravljenih z zdravilom Enbrel, in pri 3,4 % bolnikov, ki so dobivali placebo.
• Use a new alcohol swab to clean the grey stopper on the Enbrel vial.
Z novo alkoholno blazinico očistite sivi gumijasti zamašek na viali.
As the liquid level drops in the vial, you may need to withdraw the needle partially to keep the tip of the needle in the liquid.
Ko se raven raztopine v viali zniža, morate iglo deloma izvleči, da bo konica igle ostala v tekočini.
If you forget to inject Enbrel
Če ste pozabili injicirati zdravilo Enbrel
Mannitol (E421) Sucrose Trometamol
Prašek manitol (E421) saharoza trometamol
Enbrel is supplied with pre-filled syringes containing water for injection.
Zdravilu Enbrel je priložena napolnjena injekcijska brizga, ki vsebuje vodo za injekcije.
In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
V dvojno slepi s placebom nadzorovani randomizirani klinični študiji pri odraslih bolnikih s psoriatičnim artritisom je 184 bolnikov v 4. tednu dobilo tudi multivalentno polisaharidno cepivo proti pnevmokokom.
• Remove the plastic cap from the Enbrel vial (see Diagram 1).
Z viale zdravila Enbrel odstranite plastično zaporko (glejte sliko 1).
Adding water for injections
Dodajanje vode za injekcije
Slowly press the plunger to push bubbles out of the syringe and into the vial.
Počasi pritisnite na bat, da iztisnete mehurčke iz brizge v vialo.
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 nadzorovani študiji pri 205 bolnikih s psoriatičnim artritisom.
Enbrel was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Zdravilo Enbrel se ni izkazalo za genotoksičnega v vrsti študij in vivo in in vitro.
One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
En bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg zdravila Enbrel 2-krat tedensko 3 tedne, pri tem pa ni prišlo do pojava kakršnegakoli neželenega učinka.
T oxic epidermal necrolysis
toksična epidermalna nekroliza
Administration of Enbrel should be discontinued if a patient develops a serious infection.
Zdravljenje z zdravilom Enbrel je treba prekiniti, če pride do resne okužbe.
Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of Enbrel following its long-term use in patients with JIA.
Pri bolnikih z JIA prav tako niso izvedli študij za ovrednotenje učinka prekinitve zdravljenja ali zmanjšanja priporočenega odmerka zdravila Enbrel po njegovi dolgotrajni uporabi.
Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Nekatere okužbe so se pojavile nekaj tednov po začetku zdravljenja bolnikov, ki so imeli poleg revmatoidnega artritisa tudi druga obolenja (npr. sladkorno bolezen, kongestivno srčno popuščanje, aktivne ali kronične okužbe v anamnezi) (glejte poglavje 4.4).
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Če je indicirano ponovno zdravljenje z zdravilom Enbrel, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
Enbrel N = 138
Zdravilo Enbrel N = 138
From the start of part 2, the median time to flare was ≥ 116 days for patients who received Enbrel and 28 days for patients who received placebo.
Od začetka drugega dela študije je bil mediani čas do ponovnega izbruha bolezni  116 dni pri bolnikih na zdravilu Enbrel in 28 dni pri bolnikih na placebu.
In a group of 2,711 plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
V skupini 2.711 bolnikov s psoriazo v plakih, zdravljenih z zdravilom Enbrel v dvojno slepih in odprtih študijah, ki so trajale do 2,5 leta, so poročali o 30 malignomih in 43 primerih nemelanomskega kožnega raka.
In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
V drugem delu je 6 od 25 (24 %) bolnikov, ki so ostali na zdravilu Enbrel, doživelo ponoven izbruh bolezni, v primerjavi z 20 od 26 (77 %) bolnikov, ki so v drugem delu prejemali placebo (p = 0,007).
There have been reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni Po uvedbi zdravila Enbrel so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni, poročali o hipoglikemiji, zaradi katere je bilo treba pri nekaterih od teh bolnikov zmanjšati odmerek zdravila za zdravljenje sladkorne bolezni.
What Enbrel looks like and contents of the pack
Izgled zdravila Enbrel in vsebina pakiranja
24 Months
24 mesecev
In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Študija pri 49 odraslih bolnikih z revmatoidnim artritisom ni pokazala, da bi zdravljenje z zdravilom Enbrel zmanjšalo zapoznelo preobčutljivostno reakcijo, zmanjšalo raven imunoglobulinov ali spremenilo število efektorskih celic.
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 študijah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim zdravilom Enbrel in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm
-------Enbrel-----
--------Zdravilo Enbrel-------
If any of the following happen to the child, do not give the child more Enbrel.
Če se pri otroku pojavi karkoli od naslednjega, mu zdravila Enbrel ne smete več dajati.
Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (except for biosimilars), the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za etanercept (razen podobnih bioloških zdravil) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Enbrel has been shown to improve physical 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.
Ugotovili so, da zdravilo Enbrel izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in upočasni hitrost napredovanja okvar perifernih sklepov, merjenih z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
h. Disposing of supplies
h. Odstranjevanje odpadkov
Whether used alone or in combination with methotrexate, Enbrel can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Zdravilo Enbrel samo ali v kombinaciji z metotreksatom lahko upočasni razvoj poškodb v sklepih zaradi revmatoidnega artritisa in izboljša sposobnost opravljanja vsakodnevnih opravil.
Enbrel 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Učinek 25 mg odmerka zdravila Enbrel je bil pomembno boljši kot pri metotreksatu glede ocene erozije sklepov, tako po 12 kot po 24 mesecih.
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.
V šudiji 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.
Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.
Pomembne prednosti zdravila Enbrel v kombinaciji z metotreksatom pred monoterapijo z zdravilom Enbrel ali monoterapijo z metotreksatom so ugotovili tudi po 24 mesecih.
• Make sure your syringe does not contain any air bubbles.
Prepričajte se, da v brizgi ni zračnih mehurčkov.
In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident.
V študijah toksičnosti zdravila Enbrel ni bilo opaziti toksičnosti, ki bi omejevala odmerjanje, niti toksičnosti za tarčne organe.
Opportunistic infections have been reported in association with Enbrel, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
V povezavi z zdravilom Enbrel so poročali o oportunističnih okužbah, vključno z invazivnimi glivičnimi, parazitskimi (vključno s protozojskimi), virusnimi (vključno s herpesom zoster), bakterijskimi (vključno z bakterijama Listeria in Legionella) in atipičnimi mikobakterijskimi okužbami.
In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.
V kliničnih študijah je sočasna uporaba abatacepta in zdravila Enbrel zvečala pojavnost resnih neželenih učinkov.
The dosage of Enbrel is based on body weight for paediatric patients.
Odmerjanje zdravila Enbrel za pediatrične bolnike temelji na njihovi telesni masi.
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 ni priporočljiva.
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Po 12-tedenskem obdobju dvojno slepega zdravljenja so vsi bolniki prejemali zdravilo Enbrel v odmerku 0,8 mg/kg (do 50 mg) enkrat na teden še dodatnih 24 tednov.
Clinical improvement, including onset of action within 2 weeks with Enbrel 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Klinično izboljšanje, vključno z nastopom delovanja zdravila v 2 tednih pri 25 mg zdravila Enbrel, je bilo podobno tistemu, ki so ga ugotavljali v prejšnjih preskušanjih, in se je ohranjalo do 24 mesecev.
Enbrel is administered by an injection under the skin (by subcutaneous injection).
Zdravilo Enbrel se injicira pod kožo (subkutano injiciranje).
Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Dokazali so, da zdravilo Enbrel samo ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
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 nadzorovanem preskušanju pri odraslih bolnikih, ki so prejemali tudi metotreksat, opazili, da so imeli bolniki, zdravljeni z zdravilom Enbrel in anakinro, večjo stopnjo resnih okužb (7 %) in nevtropenije kot bolniki, zdravljeni z zdravilom Enbrel (glejte poglavji 4.4 in 4.8).
After you have withdrawn the Enbrel from the vial, you may have some air in the syringe.
Po tem, ko ste potegnili zdravilo Enbrel iz viale, je možno, da je v brizgo prišlo tudi nekaj zraka.
Step 1: Preparing for an Enbrel injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of the used MYCLIC pen
Korak 1: Priprava na injiciranje zdravila Enbrel Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila Enbrel Korak 4: Odstranjevanje uporabljenega peresnika MYCLIC
Approximately 15% of subjects who received Enbrel achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Približno 15 % bolnikov, zdravljenih z zdravilom Enbrel, je do 3. in 6. meseca doseglo odziv ACR 70, v primerjavi z manj kot 5 % tistih, ki so prejemali placebo.
The double-blind period was followed by an open-label period during which all patients receive Enbrel 50 mg weekly for up to an additional 92 weeks.
Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali zdravilo Enbrel v odmerku 50 mg na teden, kar je trajajo do 92 dodatnih tednov.
Adding solvent e.
Dodajanje vehikla e.
Serious allergic/anaphylactic react ions (including angioedema, bronchospasm), sarcoidosis
resne alergijske/ anafilaktične reakcije (vključno z angioedemom in bronhospazmom), sarkoidoza poslabšanje simptomov dermatomiozitisa
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 večjo stopnjo resnih okužb kot pri bolnikih, zdravljenih samo z zdravilom Enbrel ali samo z anakinro (retrospektivni podatki).
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8).
Poročali so o redkih primerih demielinizirajočih obolenj centralnega živčnega sistema (CŽS) pri bolnikih, zdravljenih s tem zdravilom (glejte poglavje 4.8).
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
V kliničnih študijah z zdravilom Enbrel, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.
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 4.8 % 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 ankilozirajočim spondilitisom, 7 % pri bolnikih s psoriazo, 9,7 % pri bolnikih z otroško psoriazo in 4,8 % pri bolnikih z juvenilnim idiopatskim artritisom.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Namesto tega so varnost in učinkovitost zdravila Enbrel ocenili v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah.
• Take the ENBREL vial out of the refrigerator and place it on a flat surface.
Vzemite vialo zdravila ENBREL iz hladilnika in jo postavite na ravno površino.
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticularcourse juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Varnost in učinkovitost zdravila Enbrel je bila ugotovljena v dvodelni študiji pri 69 otrocih s poliartikularnim potekom juvenilnega idiopatskega artritisa z različnimi tipi nastopa bolezni (poliartritis, oligoartritis, sistemski nastop).
Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications).
Bolnikom, ki tehtajo manj kot 62,5 kg, je treba odmerek natančno izračunati na podlagi mg/kg in uporabiti zdravilo Enbrel v obliki praška in vehikla za raztopino za injiciranje ali praška za raztopino za injiciranje (za odmerjanje pri specifičnih indikacijah glejte nadaljevanje).
b. One cotton ball or gauze 3.
b. Eno vato ali gazo.
When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Če pri tem v vialo iztisnete tudi raztopino, morate bat ponovno počasi izvleči, da raztopino povlečete nazaj v brizgo.
ACR 20 Month 3
ACR 20 3. mesec b
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients).
Tudi odstotek bolnikov, ki so razvili nova pozitivna avtoprotitelesa proti dvojno vijačni DNK, je bil večji, merjeno z radioimunskimi testi (15 % pri zdravilu Enbrel in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri zdravilu Enbrel in 0 % pri placebu).
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.
V študijah 3. faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli zdravilo Enbrel, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
Undesirable effects in paediatric patients with juvenile idiopathic arthritis
Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
Randomizirali so sto dvanajst (112) bolnikov, ki so 24 tednov dvakrat na teden dobivali 25 mg odmerek zdravila Enbrel (n = 57) ali placebo (n = 55).
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z učinkovino, v kateri so bili bolniki zdravljeni z zdravilom Enbrel, metotreksatom ali kombinacijo zdravila Enbrel in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including Enbrel, in the postmarketing setting.
Pri otrocih, mladostnikih in mladih odraslih (do 22. leta starosti), ki so se zdravili z antagonisti TNF (začetek zdravljenja ≤ 18 let), vključno z zdravilom Enbrel, so v obdobju trženja poročali o malignostih, med katerimi so bile tudi smrtne.