natgillin/translations-raw huggingface dataset:
However, any of the above symptoms may indicate an allergic reaction to Benepali, so you should seek immediate medical attention.
Resne alergijske reakcije so redke, vendar pa lahko kateri koli od zgoraj navedenih simptomov kaže na pojav alergijske reakcije na zdravilo Benepali, zato morate nemudoma poiskati zdravniško pomoč.
No dose adjustment is required.
Prilagajanje odmerka ni potrebno.
The safety and efficacy of etanercept in patients with chronic infections have not been evaluated.
Varnost in učinkovitost etanercepta pri bolnikih s kroničnimi okužbami nista bili ovrednoteni.
Disposal:
Odstranjevanje:
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Etanercept je fuzijska beljakovina receptorja p75 Fc za humani tumorje nekrotizirajoči faktor Pridobljen je z rekombinantno DNK tehnologijo v sesalskem ekspresijskem sistemu, in sicer v ovarijskih celicah kitajskega hrčka (CHO - Chinese Hamster Ovary).
In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
V drugi opazovalni registrski študiji, ki so jo izvajali v več državah in v kateri so primerjali tveganje za neželene izide nosečnosti pri ženskah, izpostavljenih etanerceptu v prvih 90 dneh nosečnosti (n = 425), in pri ženskah, ki so bile izpostavljene nebiološkim zdravilom (n = 3.497), niso opazili povečanega tveganja za resne prirojene napake (grobo razmerje obetov [OR - Odds Ratio] = 1,22, 95-% IZ: 0,79-1,90; prilagojeno OR = 0,96, 95-% IZ: 0,58-1,60 po prilagoditvi glede na državo, materino bolezen, pariteto, starost matere in kajenje v zgodnji nosečnosti).
Slowly push down the plunger to inject all of the Benepali solution.
Bat počasi potiskajte navzdol, da injicirajte celotno raztopino zdravila Benepali.
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
(19 %, 1,7 dogodka na bolnik-leto), navzea (9 %, 1,0 dogodek na bolnik-leto), bolečine v trebuhu (19 %, 0,74 dogodka na bolnik-leto) in bruhanje (13 %, 0,74 dogodka na bolnik-leto).
Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents.
Študij kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti z entanerceptom pri glodalcih niso opravili zaradi tvorbe nevtralizirajočih protiteles.
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥ 1:40) was higher in patients treated with etanercept (11%) than in placebotreated patients (5%).
Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA), je bil odstotek tistih, ki so razvili nova pozitivna ANA (≥ 1:40), večji pri bolnikih, ki so prejemali etanercept (11 %), kot pri tistih, ki so prejemali placebo (5 %).
Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød Denmark
Proizvajalec Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød
The known side effects of Benepali include the following in groups of decreasing frequency:
Znani neželeni učinki zdravila Benepali so v nadaljevanju navedeni v skupinah po padajoči pogostnosti:
Read the instructions for use before you start using Benepali and each time you get a refill of your prescription.
Navodila za uporabo Preden začnete uporabljati zdravilo Benepali in vsakič, ko dobite novo pakiranje, preberite ta navodila za uporabo.
Disease flare was defined as a 30% worsening in three of six JRA core set criteria and 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Ponoven izbruh bolezni je bil definiran kot 30 % poslabšanje treh od šestih osnovnih kazalcev JRA in 30 % izboljšanje največ enega od šestih glavnih kazalcev JRA ter najmanj dva aktivno prizadeta sklepa.
In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
V skupini 7.416 bolnikov, zdravljenih z etanerceptom v kliničnih preskušanjih revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, so poročali o 18 limfomih.
28b a p < 0.001, etanercept vs. placebo b p = 0.002, etanercept vs. placebo
28b a p < 0,001, etanercept proti placebu b p = 0,002, etanercept proti placebu
Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response.
Zdravnik bo na podlagi vašega odziva na zdravilo določil, koliko časa morate uporabljati zdravilo Benepali in ali je potrebno ponovno zdravljenje.
Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Stevens-Johnsonov sindrom, kožni vaskulitis (vključno z preobčutljivostnim vaskulitisom), multiformni eritem,
Autoantibody formation Treatment with Benepali may result in the formation of autoimmune antibodies (see section 4.8).
Zdravljenje z zdravilom Benepali lahko sproži nastajanje avtoimunskih protiteles (glejte poglavje 4.8).
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which etanercept was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with etanercept or sulfasalazine alone.
V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bil dodan etanercept, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično pomembno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z etanerceptom ali samo s sulfasalazinom.
The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Ni dokazano, da bi bila kombinacija etanercepta in anakinre klinično koristnejša, zato ni priporočljiva.
The long-term safety and effectiveness of etanercept 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Dolgoročna varnost in učinkovitost etanercepta, v odmerkih 0,8 mg/kg (do 50 mg) enkrat na teden, je bila ovrednotena v odprti podaljšani študiji, v kateri je sodelovalo 181 pediatričnih bolnikov s psoriazo v plakih, ki so se zdravili do 2 leti po zaključku 48-tedenske študije, navedene zgoraj.
In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with etanercept and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept (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 etanerceptom in anakinro, večjo stopnjo resnih okužb (7 %) in nevtropenije kot bolniki, zdravljeni z etanerceptom (glejte poglavji 4.4 in 4.8).
● If you have congestive heart failure, and you think your symptoms (e.g., shortness of breath or swelling of the feet) are becoming worse, or you experience new onset of such symptoms, seek medical attention immediately.
● Če imate kongestivno srčno popuščanje in menite, da se vaši simptomi (npr. zasoplost ali otekanje stopal) slabšajo ali če se ti simptomi pojavijo ponovno, takoj poiščite zdravniško pomoč.
If Benepali has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Če zdravilo Benepali po 12 tednih nima nobenega učinka na otrokovo stanje, vam bo zdravnik morda naročil, da prenehajte uporabljati to zdravilo.
Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Alergijske reakcije; vročina; izpuščaj; srbenje; protitelesa proti normalnemu tkivu (nastanek avtoprotiteles).
After a single subcutaneous dose of 25 mg etanercept, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 μg/ml, and the area under the curve was 235 ± 96.6 μg × hr/ml.
Po enkratnem subkutanem odmerku 25 mg etanercepta je bila povprečna največja koncentracija zdravila v serumu pri zdravih prostovoljcih 1,65 ± 0,66 μg/ml, površina pod krivuljo pa 235 ± 96,6 μg × h/ml.
• Do not touch the plunger rod while removing the needle cover.
• Ne dotikajte se bata, medtem ko odstranjujete pokrov igle.
Compared to placebo, treatment with etanercept resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
V primerjavi s placebom je po dajanju etanercepta prišlo do izboljšanja pri ASAS 20, ASAS 50 in ASAS 70 že v 2 tednih od začetka zdravljenja.
It is recommended that the conduct of these tests should be recorded in the patient's alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravnike predpisovalce opominjamo na nevarnost lažno negativnih rezultatov tuberkulinskega kožnega testa, še zlasti pri bolnikih, ki so hudo bolni ali imunokompromitirani.
Remove the empty pen from the skin.
Prazen injekcijski peresnik izvlecite iz kože.
• Never recap the needle.
• Pokrovčka nikoli ne natikajte nazaj na iglo.
Comprehensive instructions for administration are given in the package leaflet, section 7, ”Instructions for use”.
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo".
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months.
faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z etanerceptom ali placebom zaradi zmernega do hudega alkoholnega hepatitisa, etanercept ni bil učinkovit in stopnja smrtnosti bolnikov, zdravljenih z etanerceptom, je bila po 6 mesecih pomembno večja.
Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Zdravilo Benepali je indicirano tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa pri odraslih, ki še niso dobivali metotreksata.
Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose.
Zato dajanje zdravila Benepali pediatričnim bolnikom, ki potrebujejo odmerek, manjši kot je polnih 25 mg ali 50 mg, ni mogoče.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarni opazovani dogodek učinkovitosti v vseh štirih študijah je bil tisti delež bolnikov v vsaki zdravljeni skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75-% izboljšanje indeksa PASIPsoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Učinkovitost etanercepta so ugotavljali v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 211 pediatričnih bolnikih, starih 4 do 17 let, z zmerno do hudo psoriazo v plakih (definirano z oceno sPGA ≥ 3, ki zajema ≥ 10 % telesne površine (BSA - Body Surface Area), in PASI ≥ 12).
These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa).
Te okužbe so povzročali bakterije, mikobakterije, glivice, virusi in paraziti (vključno s protozoji).
Benepali may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Zdravilo Benepali lahko shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their etanercept dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
V študiji 3 je večina bolnikov (77 %), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek etanercepta po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
cysts and polyps)
(vključno s cistami in polipi)
Patients who develop a new infection while undergoing treatment with Benepali should be monitored closely.
Bolnike, pri katerih se med zdravljenjem z zdravilom Benepali pojavi nova okužba, je treba skrbno spremljati.
Worsening of symptoms of dermatomyositis
sarkoidoza poslabšanje simptomov dermatomiozitisa
However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Vendar pa omejeni podatki o varnosti iz registra bolnikov nakazujejo, da je varnostni profil pri subkutani uporabi zdravila v odmerku 0,8 mg/kg enkrat na teden pri otrocih, starih od 2 do 3 let, podoben profilu pri odraslih in otrocih, starih 4 leta in več (glejte poglavje 5.1).
• Sharps disposal container
• vsebnik za odstranjevanje ostrih predmetov
• Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Okužbe/sladkorna bolezen: Povejte zdravniku, če imate vi ali otrok ponavljajoče se okužbe, sladkorno bolezen ali kakšno drugo stanje, pri katerem je tveganje za okužbo večje.
Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%).
V primerjavi s placebom je bila pri bolnikih z revmatskimi obolenji, zdravljenih z etanerceptom, incidenca reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities.
Pri bolnikih s psoriatičnim artritisom in prizadetostjo več sklepov lahko zdravilo Benepali izboljša sposobnost opravljanja običajnih vsakdanjih dejavnosti.
Detailed instructions on how to inject Benepali are provided in section 7, “Instructions for use”.
Podrobna navodila o injiciranju zdravila Benepali so v poglavju 7, "Navodila za uporabo".
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Benepali.
• Rak: Preden boste prejeli zdravilo Benepali, povejte zdravniku, če imate ali ste kdaj imeli limfom (vrsta krvnega raka) ali drugo obliko raka.
Uncommon ≥ 1/1,000 to
Občasni ≥ 1/1.000 do
Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound.
Koncentracije etanercepta v serumu so bile določene z metodo encimskega imunskega testa (ELISA), ki zazna tako ELISA reaktivne razgradne produkte kot tudi izhodno snov.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
TNF in limfotoksin sta provnetna citokina, ki se vežeta na dva različna tipa receptorjev na površini celice: 55-kilodaltonske (p55) in 75-kilodaltonske (p75) receptorje TNF.
The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Varnost dolgotrajnega kombiniranega zdravljenja z etanerceptom in drugimi imunomodulirajočimi antirevmatičnimi zdravili (DMARD - Disease-Modifying AntiRheumatic Drugs) ni bila ugotovljena.
Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Zdravilo Benepali se lahko shranjuje pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več vrniti v hladilnik.
If Benepali has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.
Če zdravilo Benepali po 12 tednih nima nobenega učinka na vašo bolezen, vam zdravnik lahko naroči, da to zdravilo nehate uporabljati.
The safety and efficacy of etanercept in patients with immunosuppression have not been evaluated.
Varnost in učinkovitost etanercepta pri bolnikih z imunosupresijo nista bili ovrednoteni.
ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints 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 etanerceptom, večji kot pri bolnikih, ki so prejemali placebo (ACR 20 po 3 oz. 6 mesecih: etanercept 62 % oz. 59 %, placebo 23 % oz. 11 %; ACR 50 po 3 oz. 6 mesecih: etanercept 41 % oz. 40 %, placebo 8 % oz. 5 %; p < 0,01 za etanercept proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Benepali should be discontinued.
Take bolnike je treba nemudoma pregledati, vključno s pregledom celotne krvne slike, in v primeru krvne diskrazije prekiniti zdravljenje z zdravilom Benepali.
Paediatric patients with juvenile idiopathic arthritis The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Pediatrični bolniki z juvenilnim idiopatskim artritisom Varnost in učinkovitost etanercepta je bila ugotovljena v dvodelni študiji pri 69 otrocih s poliartikularnim potekom juvenilnega idiopatskega artritisa z različnimi tipi nastopa bolezni (poliartritis, oligoartritis, sistemski nastop).
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
• Bolezni živčevja in očesne bolezni: Povejte zdravniku, če imate vi ali otrok multiplo sklerozo, optični nevritis (vnetje očesnega živca) ali transverzni mielitis (vnetje hrbtnega mozga).
• A needle-free demonstration device
• Vadbeni pripomoček brez igle
One rheumatoid arthritis patient mistakenly self-administered 62 mg etanercept subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
En bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg etanercepta 2-krat tedensko 3 tedne, pri tem pa ni prišlo do pojava nobenega neželenega učinka.
Patients with a significant exposure to varicella virus should temporarily discontinue Benepali therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Bolniki, ki so zelo izpostavljeni virusu noric, naj začasno prekinejo zdravljenje z zdravilom Benepali, v poštev pa pridejo tudi za profilaktično zdravljenje z imunoglobulinom proti virusu varicella-zoster.
Both TNFRs exist naturally in membrane-bound and soluble forms.
Oboji receptorji TNF v naravi obstajajo v dveh oblikah, tj. vezani na membrano in v topni obliki.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying antirheumatic drug therapy has been inadequate.
Zdravljenje aktivnega in progresivnega psoriatičnega artritisa pri odraslih, če je bil odziv na zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili nezadosten.
Etanercept was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Etanercept se ni izkazal za genotoksičnega v vrsti študij in vivo in in vitro.
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
• hud izpuščaj, srbenje ali koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo).
Efficacy response in placebo-controlled nr-AxSpa study: Percent of patients achieving endpoints Double-Blind Clinical
Odziv glede učinkovitosti v s placebom nadzorovani študiji nr-AxSpa: Odstotek bolnikov, ki so dosegli opazovane dogodke
Non-melanoma skin cancers* (see section 4.4)
nemelanomski kožni rak* (glejte poglavje 4.4)
Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving etanercept 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 etanercept, kot pri kontrolnih bolnikih, še zlasti pri bolnikih s psoriazo.
Responses of patients with ankylosing spondylitis in a placebo-controlled trial Percent of Patients
Odzivi bolnikov z ankilozirajočim spondilitisom v preskušanju, nadzorovanem s placebom Odstotek bolnikov
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Učinkovitost etanercepta je bila ocenjena v randomizirani, dvojno slepi in s placebom nadzorovani študiji pri 205 bolnikih s psoriatičnim artritisom.
Patients were observed off treatment for the occurrence of rebound (PASI ≥ 150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Bolnike so brez zdravljenja spremljali glede preobratnih znakov (PASI ≥ 150 % izhodiščnega) in časa do recidiva (opredeljenega kot izginotje vsaj polovice izboljšanja, doseženega med izhodiščem in 24. tednom).
Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of etanercept compared to the 349 adult rheumatoid arthritis patients.
Nekateri neželeni učinki so bili pogosteje opaženi pri 69 bolnikih z juvenilnim idiopatskim artritisom, ki so etanercept prejemali 3 mesece, kot pri 349 odraslih bolnikih z revmatoidnim artritisom.
EU/1/15/1074/006 multipack of 8 pre-filled syringes (2 packs of 4) EU/1/15/1074/007 multipack of 24 pre-filled syringes (6 packs of 4)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1074/006 večodmerno pakiranje z 8 napolnjenimi injekcijskimi brizgami (2 pakiranji po 4) EU/1/15/1074/007 večodmerno pakiranje s 24 napolnjenimi injekcijskimi brizgami (6 pakiranj po 4)