natgillin/translations-raw huggingface dataset:
Assemble the additional supplies you will need for your injection.
Zberite predmete, ki jih boste potrebovali za injekcijo, in jih položite na izbrano površino:
In another open-label single-arm study, 60 patients with extended oligoarthritis (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with Enbrel at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
V drugi odprti študiji z eno skupino se je z zdravilom Enbrel v odmerku 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden zdravilo 60 bolnikov z razširjenim oligoartritisom (15 bolnikov, starih od 2 do 4 leta, 23 bolnikov, starih od 5 do 11 let, in 22 bolnikov, starih od 12 do 17 let), 38 bolnikov z artritisom, povezanim z entezitisom (starih od 12 do 17 let) in 29 bolnikov s psoriatičnim artritisom (starih od 12 do 17 let).
Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes).
Pred injiciranjem je treba napolnjene injekcijske peresnike zdravila Enbrel za enkratno uporabo segreti na sobno temperaturo (počakati približno 15 do 30 minut).
ACR 50 Month 3
ACR 50 3. mesec b
Methotrexate (n = 228)
Opazovani dogodek metotreksat (n = 228)
The Enbrel solution should not be mixed with any other medicine before use.
Raztopine zdravila Enbrel pred uporabo ne smete mešati z drugimi zdravili.
Enbrel should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
Pri otrocih s poliartritisom ali z razširjenim oligoartritisom, mlajših od 2 let, otrocih z artritisom, povezanim z entezitisom, ali s psoriatičnim artritisom, mlajših od 12 let, in otrocih s psoriazo, mlajših od 6 let, se zdravila Enbrel običajno ne sme uporabljati.
T hrombocyt openia, anaemia, leukopenia, neutropenia
Bolezni krvi in limfatičnega sistema trombocitopenija, anemija, levkopenija, nevtropenija pancitopenija*
Each pack contains 4 single-dose vials and 8 alcohol swabs.
Eno pakiranje vsebuje 4 enoodmerne viale in 8 alkoholnih blazinic.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
Odmerke zdravila Enbrel po 25 mg (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placebo so dajali subkutano dvakrat na teden 6 mesecev.
Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Farmakokinetika zdravila Enbrel pri bolnikih z revmatoidnim artritisom, ankilozirajočim spondilitisom in psoriazo v plakih je podobna.
The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg Enbrel with placebo.
Učinkovitost zdravila Enbrel pri bolnikih z ankilozirajočim spondilitisom je bila ocenjena v 3 randomiziranih dvojno slepih študijah, kjer so primerjali uporabo 25 mg zdravila Enbrel dvakrat tedensko s placebom.
Patients in this study received a dose of 25 mg or 50 mg Enbrel, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg Enbrel twice weekly for an additional 24 weeks.
Bolniki v tej študiji so dobivali odmerek 25 mg ali 50 mg zdravila Enbrel ali placebo dvakrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 25 mg zdravila Enbrel dvakrat na teden dodatnih 24 tednov.
Other presentations of Enbrel are available in strengths of 10 mg, 25 mg, and 50 mg.
Druge oblike zdravila Enbrel so na voljo v jakostih 10 mg, 25 mg in 50 mg.
70b a: 25 mg Enbrel SC twice weekly b: p < 0.001, Enbrel vs. placebo c: p < 0.01, Enbrel vs. placebo
6. mesec a: 25 mg zdravila Enbrel subkutano dvakrat na teden b: p < 0,001, zdravilo Enbrel v primerjavi s placebom c: p < 0,01, zdravilo Enbrel v primerjavi s placebom
Similarly, the significant advantages for Enbrel monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Podobno so po 24 mesecih ugotovili tudi pomembne prednosti monoterapije z zdravilom Enbrel pred monoterapijo z metotreksatom.
Re-introduction of treatment with Enbrel after discontinuation 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 študij so bile velikosti odziva po ponovni uvedbi zdravljenja z zdravilom Enbrel po prekinitvah, ki so trajale do 24 mesecev, enake kot pri bolnikih, ki so prejemali zdravilo Enbrel brez prekinitve zdravljenja.
T uberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
tuberkuloza, oportunistična okužba (vključno z invazivnimi glivičnimi, protozojskimi, bakterijskimi, atipičnimi mikobakterijskimi, virusnimi okužbami in okužbami z bakterijo Legionella)*
There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
Zdravila Enbrel se običajno ne uporablja za zdravljenje juvenilnega idiopatskega artritisa pri otrocih, mlajših od 2 let.
Withdrawing the Enbrel solution from the vial
Jemanje raztopine zdravila Enbrel iz viale
Clinical responses among nr-AxSpa patients who received Enbrel were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy.
Klinični odzivi pri bolnikih z nr-AxSpa, ki so prejemali Enbrel, so bili vidni ob prvem obisku (po 2 tednih) in so se vzdrževali med celotnim 2-letnim zdravljenjem.
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Enbrel solution in the syringe to reach room temperature.
Ko brizgo vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Enbrel v brizgi segreje na sobno temperaturo.
Gather the items that you will need for your injection, and place them on the chosen surface: a. One MYCLIC pre-filled pen and one alcohol swab (take these from the carton of pens you keep in your refrigerator).
prozorno okence za pregledovanje beli pokrovček igle datum izteka roka uporabnosti zeleni aktivacijski gumb a. En napolnjen peresnik MYCLIC in eno alkoholno blazinico (vzemite ju iz škatle s peresniki, ki jo hranite v hladilniku).
The active ingredient in Enbrel is etanercept.
Učinkovina zdravila Enbrel je etanercept.
Among patients receiving Enbrel, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
Pri bolnikih na zdravilu Enbrel se je klinični odziv običajno pojavil že v prvem ali drugem tednu zdravljenja, skoraj vedno pa je nastopil do 3. meseca.
EU/1/99/126/003 4 vials EU/1/99/126/004 8 vials EU/1/99/126/005 24 vials
EU/1/99/126/003 4 viale EU/1/99/126/004 8 vial EU/1/99/126/005 24 vial
Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with Enbrel during pregnancy.
Zaznali so ga v serumu dojenčkov, rojenim bolnicam, ki so se med nosečnostjo zdravile z zdravilom Enbrel.
The efficacy of Enbrel in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Odrasli bolniki z radiografsko nezaznavnim aksialnim spondilartritisom Učinkovitost zdravila Enbrel so pri bolnikih z radiografsko nezaznavnim aksialnim spondilartritisom (nr-AxSpa) ocenili v randomizirani 12-tedenski, dvojno slepi, s placebom nadzorovani študiji.
Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of Enbrel (see section 4.8).
Pri uporabi zdravila Enbrel so poročali o primerih resnih okužb, sepse, tuberkuloze in oportunističnih okužb, vključno z invazivnimi glivičnimi okužbami, listeriozo in legionelozo (glejte poglavje 4.8).
Choosing an injection site
Izbira mesta injiciranja
Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
Vaš zdravnik se bo morda odločil, da bo vas ali vašega otroka tudi po koncu zdravljenja z zdravilom Enbrel spremljal glede prisotnosti okužb.
The efficacy of Enbrel 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 a sPGA
Učinkovitost zdravila Enbrel 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).
Patients should be tested for HBV infection before initiating treatment with Enbrel.
Pred uvedbo zdravljenja z zdravilom Enbrel je treba bolnike testirati na okužbo s HBV.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
V eni študiji pri otrocih z juvenilnim idiopatskim artritisom, starih od 4 do 17 let, se je pri 43 od 69 otrok (62 %) med trimesečnim zdravljenjem z zdravilom Enbrel v času študije (prvi del, odprta) pojavila okužba.
• Hepatitis C: Tell your doctor if the child has hepatitis C. Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.
Hepatitis C: Povejte zdravniku, če ima vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom Enbrel za primer, če bi se okužba poslabšala.
Enbrel 0.8 mg/kg Once Weekly (N = 106)
50 mg 1x/teden n = 166
Setting up for an injection c.
Priprava na injiciranje c.
Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.
Pri bolnikih, zdravljenih z zdravilom Enbrel, so v obdobju trženja poročali o zelo redkih primerih karcinoma Merklovih celic.
Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including Enbrel, has been reported.
Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B (HBV) in so se zdravili z antagonisti TNF, vključno z zdravilom Enbrel, so poročali o reaktivaciji hepatitisa B. Poročila vključujejo tudi reaktivacijo hepatitisa B pri anti-HBc pozitivnih, vendar HBsAg negativnih bolnikih.
Enbrel is available in strengths of 10, 25 and 50 mg.
Zdravilo Enbrel je na voljo v jakostih 10, 25 in 50 mg.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel.
Med obdobjem randomiziranega prekinjanja zdravljenja se je recidiv bolezni (izguba odziva PASI 75) pojavil pri pomembno več bolnikih, ki so bili ponovno v skupini s placebom, kot pri bolnikih, ki so bili ponovno v skupini z zdravilom Enbrel.
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
Pri bolnikih, ki so bili zdravljeni z zdravilom Enbrel, so poročali o redkih primerih pancitopenije in zelo redkih primerih aplastične anemije, tudi s smrtnim izidom.
The other ingredients are:
Potrebujete še naslednje:
• While still in the plastic package, place the vial adaptor on top of the Enbrel vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper (see Diagram 2).
Adapter viale pustite v plastični embalaži in ga položite na vrh viale zdravila Enbrel tako, da bo konica adapterja viale poravnana z dvignjenim delom zamaška na viali (glejte sliko 2).
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Enbrel in case the infection worsens.
Hepatitis C: Povejte zdravniku, če imate vi ali vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom Enbrel za primer, če bi se okužba poslabšala.
Radiographic progression at 12 months was significantly less in the Enbrel group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Po 12 mesecih zdravljenja je bilo radiografsko napredovanje pri bolnikih, ki so jih zdravili z zdravilom Enbrel, statistično pomembno počasnejše kot pri bolnikih, ki so jih zdravili z metotreksatom; kombinacija obeh zdravil pa je radiografsko napredovanje upočasnila statistično pomembno učinkoviteje kot eno samo zdravilo (glejte spodnjo sliko).
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 bolnikih z revmatoidnim artritisom so bile povprečne koncentracije v serumu v stanju dinamičnega ravnovesja naslednje: pri zdravljenju z zdravilom Enbrel v odmerku 50 mg enkrat na teden (n = 21) je vrednost Cmax znašala 2,4 mg/l, vrednost Cmin 1,2 mg/l, delna AUC pa 297 mg·h/l, pri zdravljenju z zdravilom Enbrel v odmerku 25 mg dvakrat na teden (n = 16) pa je vrednost Cmax znašala 2,6 mg/l, vrednost Cmin 1,4 mg/l, delna AUC pa 316 mg·h/l.
The needle cover of the pre-filled syringe contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by, or when Enbrel is administered to, persons with known or possible latex sensitivity.
Pokrovček igle napolnjene injekcijske brizge vsebuje lateks (posušen naravni kavčuk), ki lahko povzroči preobčutljivostne reakcije, če z zdravilom Enbrel ravna oseba z znano ali možno preobčutljivostjo na lateks ali če ga damo taki osebi.
Doses of 10 mg or 25 mg Enbrel were administered subcutaneously (SC) twice a week for up to 24 months.
Odmerki 10 mg ali 25 mg zdravila Enbrel so bili dani subkutano (s.c.) 2-krat tedensko do 24 mesecev.
Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Zdravniki morajo biti zelo previdni, kadar se odločajo za zdravljenje s tem zdravilom pri bolnikih s ponavljajočimi se ali kroničnimi okužbami v anamnezi ali z drugimi osnovnimi stanji (kot je na primer napredovala ali neurejena sladkorna bolezen), ki bi lahko povečala dovzetnost bolnikov za okužbe.
After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Enbrel solution in the pen to reach room temperature.
Ko napolnjeni peresnik vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Enbrel v peresniku segreje na sobno temperaturo.
Each vial of Enbrel 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Ena viala zdravila Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih vsebuje 10 mg etanercepta.
Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy.
Pri bolnikih z juvenilnim idiopatskim artritisom, ki se v 3 mesecih po uvedbi zdravljenja z zdravilom Enbrel ne odzovejo na zdravljenje, niso izvedli študij za ovrednotenje učinka kontinuiranega zdravljenja z zdravilom Enbrel.
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Enbrel was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Rezultati za zdravilo Enbrel so bili statistično pomembno boljši od placeba po vseh kriterijih ACR, prav tako pa tudi po tistih merilih aktivnosti revmatoidnega artritisa, ki v kriterije odziva po ACR niso vključeni, na primer jutranja okorelost.
In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Na splošno so bili neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom po vrsti in pogostnosti podobni tistim pri odraslih.
Preparing the Enbrel dose for injection
Priprava odmerka zdravila Enbrel za injiciranje
Powder: Mannitol (E421), sucrose, and trometamol.
Pomožne snovi so: prašek: manitol (E421), saharoza in trometamol.
What Enbrel contains
Kaj vsebuje zdravilo Enbrel
Responses were measured using ACR Pedi 30 , defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Odzive so merili po lestvici ACR Pedi 30; izboljšanje je bilo določeno kot  30 % izboljšanje v vsaj treh od šestih glavnih kazalcev aktivnosti bolezni JRA in  30 % poslabšanje največ enega od šestih glavnih kazalcev aktivnosti bolezni JRA (število aktivno prizadetih sklepov, omejenost gibanja, zdravnikova splošna ocena, splošna ocena s strani bolnika ali staršev, ocena funkcionalnosti in hitrost sedimentacije eritrocitov).
Wipe the site where Enbrel is to be injected with the alcohol swab, using a circular motion.
Mesto, kjer nameravate vbrizgati zdravilo Enbrel, s krožnim gibom obrišite z alkoholno blazinico.
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.
Zaradi majhnega števila proučevanih bolnikov ni zadostnih dokazov glede učinkovitosti zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in z artritisom mutilansom.
In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p<0.0001).
V študiji 1 je bil v 12. tednu delež bolnikov z odzivom PASI 75 pomembno večji v skupini, zdravljeni z zdravilom Enbrel (30 %), kot v skupini, ki je dobivala placebo (2 %) (p  0,0001).
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
• Remove the plastic cap from the Enbrel vial.
Z viale zdravila Enbrel odstranite plastično zaporko.
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 µg•hr/ml and 474 µg•hr/ml for 50 mg Enbrel once weekly (N = 154) and 25 mg twice weekly (N = 148), respectively.
Pri analizi populacijske farmakokinetike pri bolnikih z ankilozirajočim spondilitisom so vrednosti AUC etanercepta v stanju dinamičnega ravnovesja pri uporabi zdravila Enbrel v odmerku 50 mg enkrat na teden (n = 154) znašale 466 μg·h/ml, pri uporabi zdravila Enbrel v odmerku 25 mg dvakrat na teden (n = 148) pa 474 μg·h/ml.
Thus the combined use of Enbrel and anakinra is not recommended (see sections 4.5 and 4.8).
Ta kombinacija ni pokazala povečane klinične koristi, zato uporaba zdravila Enbrel skupaj z anakinro ni priporočljiva (glejte poglavji 4.5 in 4.8).
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Učinkovitost zdravila Enbrel je bila ugotovljena v randomizirani, dvojno slepi klinični študiji, nadzorovani s placebom.
You should allow 15 to 30 minutes for the Enbrel solution in the syringe to reach room temperature.
Počakajte 15 do 30 minut, da se raztopina zdravila Enbrel v brizgi segreje na sobno temperaturo.
Baseline scoreb Week 52 scoreb
DAS ocena v izhodišču ocena po 52 tednih remisija
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz kateregakoli razloga izpadli iz študije, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z zdravilom Enbrel kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
The MYCLIC pen contains a clear, colourless to pale yellow or pale brown solution for injection.
Injekcijski peresnik MYCLIC vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje.
Allergic reactions associated with Enbrel administration have been reported commonly.
V povezavi z uporabo zdravila Enbrel so pogosto poročali o alergijskih reakcijah.
Your doctor may decide if the child needs less anti-diabetic medicine while taking Enbrel.
Zdravnik lahko odloči, da bo otrok med jemanjem zdravila Enbrel potreboval manj zdravila za sladkorno bolezen.
• Cancer: Tell your doctor if the child has or has ever had lymphoma (a type of blood cancer) or any other cancer before the child is given Enbrel.
Rak: Preden bo vaš otrok prejel zdravilo Enbrel, povejte zdravniku, če ima ali je vaš otrok imel limfom (vrsta krvnega raka) ali drugo obliko raka.
The needle cap of the pre-filled pen contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by or when Enbrel is administered to persons with known or possible latex sensitivity.
Pokrovček igle napolnjenega injekcijskega peresnika vsebuje lateks (posušen naravni kavčuk), ki lahko povzroči preobčutljivostne reakcije, če z zdravilom Enbrel ravna oseba z znano ali možno preobčutljivostjo na lateks ali če ga damo taki osebi.
For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Pri zdravljenju revmatoidnega artritisa se zdravilo Enbrel običajno uporablja skupaj z metotreksatom.
Clinical Efficacy Results at 12 Months: Comparison of Enbrel vs Methotrexate vs Enbrel in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration
Rezultati klinične učinkovitosti po 12 mesecih: primerjava med zdravilom Enbrel, metotreksatom in kombinacijo zdravila Enbrel in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let
Placing the needle on the syringe g.
Namestitev igle na injekcijsko brizgo g.
Name and address of the manufacturers responsible for batch release Wyeth Pharmaceuticals
Ime in naslov izdelovalcev, odgovornih za sproščanje serij
TEXT FOR PRE-FILLED SYRINGE LABEL - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg napolnjena injekcijska brizga)
In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z zdravilom Enbrel (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
The instructions below explain how to use the MYCLIC pen to inject Enbrel.
V tem navodilu je opisana uporaba injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel.
Your doctor will determine if Enbrel is an appropriate treatment.
Zdravnik bo presodil o primernosti zdravljenja z zdravilom Enbrel.