natgillin/translations-raw huggingface dataset:
Enbrel should be used with caution in patients with a history of hepatitis C.
Pri bolnikih z anamnezo hepatitisa C morate Enbrel uporabljati previdno.
• Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 1).
S potegom naravnost proč od brizge odstranite pokrovček igle z injekcijske brizge in pri tem pazite, da se s prsti ne dotaknete igle in da se z iglo ne dotaknete ničesar (glejte sliko 1).
Radiographic Progression: Comparison of Enbrel vs Methotrexate in Patients with RA of <3 Years Duration
Radiografsko napredovanje: primerjava zdravila Enbrel z metotreksatom pri bolnikih z RA, ki je trajal < 3 leta
Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Med bolniki s psoriatičnim artritisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 4 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
Enbrel 10 mg powder and solvent for solution for injection for paediatric use is supplied as a white powder with solvent for solution for injection (powder for injection).
Zdravilo Enbrel 10 mg prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih je na voljo v obliki belega praška in vehikla za raztopino za injiciranje (prašek za injekcijo).
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 zdravljenje le bilo potrebno, pa je prejela lokalna zdravila, npr. kortikosteroide, ali peroralne antihistaminike.
Cartons contain 4 vials of Enbrel, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Ena škatla vsebuje 4 viale zdravila Enbrel, 4 napolnjene injekcijske brizge z vodo za injekcije, 4 injekcijske igle, 4 adapterje za vialo in 8 alkoholnih blazinic.
2 Alcohol swabs
2 alkoholni blazinici
You will also need 1 ml of water for injections and a syringe to administer Enbrel 16.
Za injiciranje zdravila Enbrel boste potrebovali tudi 1 ml vode za injekcije in injekcijsko brizgo.
Again, do not touch the needle or allow it to touch any surface.
Pri tem zopet pazite, da se igle ne dotaknete ali z njo kam zadenete.
Do not shake the pre-filled syringe of Enbrel.
Napolnjenih injekcijskih brizg zdravila Enbrel ne smete tresti.
Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): resne okužbe (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov, okužbo krvi in okužbami na različnih mestih); poslabšanje kongestivnega srčnega popuščanja; nizko število rdečih krvnih celic, nizko število belih krvnih celic, nizko število nevtrofilcev (vrste belih krvnih celic); nizko število krvnih ploščic; kožni rak (razen melanoma); lokalizirano otekanje kože (angioedem); koprivnica (rdeče ali blede kožne spremembe nad ravnijo kože, ki pogosto srbijo); očesno vnetje; luskavica (na novo nastala ali poslabšanje obstoječe); vnetje krvnih žil, ki negativno vpliva na več organov; zvečane vrednosti jetrnih encimov pri krvnih preiskavah (pri bolnikih, ki sočasno prejemajo metotreksat, so zvečane vrednosti jetrnih encimov pri krvnih preiskavah pogoste); krči in bolečina v trebuhu, driska, izguba telesne mase ali kri v blatu (znaki težav s črevesjem).
In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare.
V drugem delu študije pa so bolnike s kliničnim odzivom na zdravilo Enbrel na 90. dan randomizirali v dve podskupini: ena je nadaljevala zdravljenje z zdravilom Enbrel, druga pa je nadaljnje štiri mesece prejemala placebo - pri obeh so ocenjevali ponoven izbruh bolezni.
Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Odzivi bolnikov s psoriatičnim artritisom v preskušanju, nadzorovanem s placebom Odstotek bolnikov Placebo Zdravilo Enbrel
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including Enbrel.
Pri bolnikih, zdravljenih z antagonisti TNF, vključno z zdravilom Enbrel, so poročali o melanomu in nemelanomskem kožnem raku (NMSC- Non-Melanoma Skin Cancer).
Step 3: Injecting the Enbrel solution
Korak 3: Injiciranje raztopine zdravila Enbrel
Patients received Enbrel 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Bolniki so 12 tednov enkrat na teden prejemali zdravilo Enbrel v odmerku 0,8 mg/kg (do 50 mg) ali placebo.
If any of the following happen, do not inject more Enbrel.
Če se pojavi karkoli od naslednjega, zdravila Enbrel ne smete več uporabljati.
24 MYCLIC pre-filled pens 24 alcohol swabs
24 napolnjenih injekcijskih peresnikov MYCLIC 24 alkoholnih blazinic
• Hepatitis B: Tell your doctor if the child has or has ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before the child begins treatment with Enbrel.
Hepatitis B: Povejte zdravniku, če ima ali je vaš otrok kdaj imel hepatitis B. Preden se bo vaš otrok začel zdraviti z zdravilom Enbrel, mora zdravnik opraviti test prisotnosti okužbe s hepatitisom B. Pri bolnikih, ki so kdaj že bili okuženi z virusom hepatitisa B, lahko zdravljenje z zdravilom Enbrel povzroči ponoven zagon hepatitisa B. V takem primeru morate zdravilo Enbrel prenehati uporabljati.
Carefully dispose of any Enbrel solution that has not been injected within 6 hours.
Raztopino zdravila Enbrel, ki je v 6 urah po pripravi niste injicirali, previdno zavrzite.
Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received Enbrel without interruption.
Dolgotrajna odzivnost na neprekinjeno zdravljenje z zdravilom Enbrel je bila v odprtih podaljšanih kliničnih preskušanjih potrjena za obdobja do 10 let.
Serious and fatal infections have been reported during use of Enbrel; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Med povzročitelji, o katerih so poročali, so bile bakterije, mikobakterije (vključno s tuberkulozo), virusi in glivice.
Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
2 pre-filled syringes 2 alcohol swabs
2 napolnjeni injekcijski brizgi 2 alkoholni blazinici
Int erst it ial lung disease (including pneumonitis and pulmonary fibrosis)*
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč (vključno s pnevmonitisom in pljučno fibrozo)*
CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinat ing event s, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropat hy, and multifocal motor neuropathy (see section 4.4), seizure
Bolezni živčevja demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo, ali lokalizirana demielinizirajoča stanja, kot sta optični nevritis in transverzni mielitis (glejte poglavje 4.4), demielinizacija perifernega živčevja, vključno z GuillainBarréjevim sindromom, kronično vnetno demielinizirajočo polinevropatijo, demielinizirajočo polinevropatijo in multifokalno motorično nevropatijo (glejte poglavje 4.4), epileptični napad
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Če je bolnik pozitiven na HBV, je pred uvedbo zdravljenja z zdravilom Enbrel priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Enbrel bolnikom, ki so že bili okuženi s
Among patients with ankylosing spondylitis who received Enbrel, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Med bolniki z ankilozirajočim spondilitisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev zdravljenja.
Among patients with plaque psoriasis who received Enbrel, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Med bolniki s psoriazo v plakih, ki so dobivali zdravilo Enbrel, je bil pomemben odziv v primerjavi s placebom opazen na prvem pregledu (po 2 tednih) in se je ohranil skozi 24 tednov zdravljenja.
Enbrel was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Zdravilo Enbrel so dobivali 6 mesecev zapored v odmerkih 25 mg enkrat na teden, 25 mg dvakrat na teden ali 50 mg dvakrat na teden.
At week 12, more patients randomised to Enbrel had positive efficacy responses (e.g., PASI 75) than those randomised to placebo.
V 12. tednu je imelo pozitivne odzive glede učinkovitosti (npr. PASI 75) več bolnikov v skupini z zdravilom Enbrel kot v skupini s placebom.
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
Opravljena je bila analiza, v kateri so vse bolnike, ki so iz kakršnegakoli razloga izpadli iz študije, obravnavali, kot da jim je bolezen napredovala.
Radiographic Progression: Comparison of Enbrel vs Methotrexate vs Enbrel in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Radiografsko napredovanje: primerjava med zdravilom Enbrel, metotreksatom in kombinacijo zdravila Enbrel in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let (rezultati pri 12 mesecih)
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
V kliničnih študijah z zdravilom Enbrel, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Enbrel.
Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom Enbrel izpostavljeni noricam.
8 MYCLIC pre-filled pens 8 alcohol swabs
8 napolnjenih injekcijskih peresnikov MYCLIC 8 alkoholnih blazinic
• With the needle still in the vial, hold the vial upside down at eye level.
Ko je igla še vedno v viali, dvignite vialo tako, da bo obrnjena na glavo, približno v višini oči.
CARTON TEXT - EU/1/99/126/003-005
BESEDILO NA NALEPKI VIALE - EU/1/99/126/003-005
Women using Enbrel should not breast-feed, since Enbrel passes into human breast milk.
Zdravilo Enbrel prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom Enbrel ne smejo dojiti.
The three recommended injection sites for Enbrel using a pre-filled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1).
Za injiciranje napolnjene injekcijske brizge zdravila Enbrel so priporočljiva tri injekcijska mesta: (1) na sredini sprednjega dela stegna; (2) na trebuhu, razen v predelu 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte sliko 1).
By looking though the inspection window, the solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.
Pri pogledu skozi okence za pregledovanje mora biti raztopina bistra do rahlo opalescentna, brezbarvna do bledo rumena oziroma bledo rjava ter lahko vsebuje majhne prosojne ali bele delce beljakovine.
• With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 10).
S hitrim in kratkim gibom potisnite iglo do konca v kožo pod kotom 45 do 90 stopinj (glejte sliko 10).
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Enbrel to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease.
Pri bolnikih z demielinizirajočimi obolenji, ki so obstajala že prej ali so nastopila pred kratkim, ali pri tistih, ki imajo povečano tveganje za razvoj demielinizirajoče bolezni, je treba pred zdravljenjem z zdravilom Enbrel skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
CARTON TEXT - EU/1/99/126/022 (For paediatric use)
BESEDILO NA ŠKATLI - EU/1/99/126/022 (za uporabo pri otrocih)
Enbrel should not be used if all the powder in the vial is not dissolved within 10 minutes.
Zdravila Enbrel ne smete uporabiti, če se ves prašek v viali ne raztopi v 10 minutah; v tem primeru to vialo zavrzite in vzemite novo.
Do not mix the Enbrel solution with any other medicine.
Raztopine zdravila Enbrel ne smete mešati z nobenim drugim zdravilom.
Congestive heart failure (Cardiac failure congestive) 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 (KSP).
Dosing for adult patients (aged 18 years or over) Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Psoriatični artritis, ankilozirajoči spondilitis in radiografsko nezaznavni aksialni spondilartritis Priporočeni odmerek je 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden.
Enbrel 25 mg is supplied as a white powder and solvent for solution for injection (powder for injection).
Zdravilo Enbrel 25 mg je na voljo v obliki belega praška in vehikla za raztopino za injiciranje (prašek za injekcijo).
Using the MYCLIC pre-filled pen to inject Enbrel
Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel
Enbrel 50 mg solution for injection in pre-filled syringe Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih zdravila Enbrel pri odraslih bolnikih z revmatoidnim artritisom.
Look for the needle tip inside the stopper window (see Diagram 3).
Skozi okence v zamašku preverite, ali vidite konico igle (glejte sliko 3).
CARTON TEXT - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
BESEDILO NA ŠKATLI - EU/1/99/126/016-018 (50 mg napolnjena injekcijska brizga)
• The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 17).
Za injiciranje zdravila Enbrel so priporočljiva tri injekcijska mesta: (1) na sredini sprednjega dela stegna; (2) na trebuhu, razen v predelu 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte sliko 17).
• Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
težave pri požiranju ali dihanju; otekanje obraza, žrela, rok ali nog; občutek živčnosti ali tesnobe, utripajoč občutek, nenadna pordelost kože in/ali občutek toplote;
• The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
Za injiciranje zdravila Enbrel so priporočljiva tri injekcijska mesta: (1) na sredini sprednjega dela stegna; (2) na trebuhu, razen v predelu 5 cm okrog popka; in (3) na zunanjem delu nadlakti (glejte sliko 9).
After preparing the Enbrel solution, immediate use is recommended.
Priporočljivo je, da pripravljeno raztopino zdravila Enbrel nemudoma uporabite.
Enbrel 25 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Enbrel je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
The following instructions explain how to prepare and inject Enbrel.
V tem navodilu sta opisana priprava in dajanje injekcij zdravila Enbrel.
Enbrel 25 mg solution for injection in pre-filled syringe Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Enbrel 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Injekcijska brizga iz prozornega stekla (steklo tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in plastičnim batom.
CARTON TEXT - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
BESEDILO NA ŠKATLI - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg napolnjena injekcijska brizga)
• Congestive heart failure: Tell your doctor if the child has a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri otroku kdaj pojavilo kongestivno srčno popuščanje.
• Leave the syringe in place.
Brizgo pustite v viali.
• Chickenpox: Tell your doctor if the child is exposed to chickenpox when using Enbrel.
Norice: Povejte zdravniku, če je bil otrok med zdravljenjem z zdravilom Enbrel izpostavljen noricam.
Common ≥ 1/100 to
Pogosti ≥ 1/100 do < 1/10
Enbrel 50 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Enbrel 50 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Enbrel je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro, brezbarvno do bledo rumeno oziroma bledo rjavo raztopino za injiciranje (raztopino za injiciranje).
Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC prefilled pen after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na napolnjenem injekcijskem peresniku MYCLIC poleg oznake ''Uporabno do'' ali ''Upor.
Detailed instructions on how to inject Enbrel are provided in section 7, “Using the MYCLIC pre-filled pen to inject Enbrel”.
Podrobna navodila o injiciranju zdravila Enbrel so v poglavju 7 “Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel”.
Powder: Mannitol, sucrose and trometamol.
Pomožne snovi v zdravilu Enbrel so: prašek: manitol, saharoza in trometamol.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
138 bolnikov je prejemalo 25 mg odmerke zdravila Enbrel (na podlagi študij za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba subkutano dvakrat na teden 6 mesecev.
Do not use this medicine after the expiry date which is stated on the carton and the label after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake ''Uporabno do'' ali ''Upor.
Step 1: Preparing for an Enbrel injection 1.
Korak 1: Priprava na injiciranje zdravila Enbrel
12b
6. mesec b
The Enbrel pre-filled pen is available in 25 mg and 50 mg strengths.
Napolnjena injekcijska brizga je na voljo v jakostih 25 mg in 50 mg.
Methotrexate
Odmerjanje
• Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Enbrel needs to be used with caution under these circumstances.
Kongestivno srčno popuščanje: Povejte zdravniku, če se je pri vas ali otroku kdaj pojavilo kongestivno srčno popuščanje.
Contact your doctor before using Enbrel if the needle cap will be handled by, or Enbrel will be given to, someone with a known or possible hypersensitivity (allergy) to latex.
Če bo s pokrovčkom igle rokovala ali zdravilo Enbrel dobivala oseba z znano ali možno preobčutljivostjo (alergijo) na lateks, se pred uporabo zdravila Enbrel posvetujte z zdravnikom.
Enbrel is reconstituted with 1 ml water for injections before use and administered by subcutaneous injection.
Pred uporabo in subkutanim injiciranjem zdravilo Enbrel rekonstituirajte v 1 ml vode za injekcije.
Talk to your doctor before taking Enbrel.
Pred začetkom uporabe zdravila Enbrel se posvetujte z zdravnikom.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject Enbrel."
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel".
In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebocontrolled study of 356 patients with active ankylosing spondylitis.
V četrti, dvojno slepi in s placebom nadzorovani študiji so pri 356 bolnikih z aktivnim ankilozirajočim spondilitisom vrednotili varnost in učinkovitost dajanja zdravila Enbrel v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem zdravila Enbrel v odmerku 25 mg dvakrat na teden.
Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs. methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs. Enbrel.
Vrednosti p za primerjavo po parih: * = p < 0,05 za primerjavo zdravila Enbrel z metotreksatom, † = p < 0,05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z metotreksatom in  = p < 0,05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z zdravilom Enbrel.
Contents of the pack and other information Instructions for preparing and giving an injection of Enbrel (See overleaf)
Navodila za pripravo in dajanje injekcije zdravila Enbrel (glejte drugo stran navodila)
Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel.
Pri bolnikih, zdravljenih z zdravilom Enbrel, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
Each vial of Enbrel contains 10 mg etanercept.
Ena viala zdravila Enbrel vsebuje 10 mg etanercepta.
Enbrel 25 mg powder for solution for injection
Enbrel 25 mg prašek za raztopino za injiciranje
Contents of the pack and other information Using the MYCLIC pre-filled pen to inject Enbrel (See overleaf)
Uporaba napolnjenega injekcijskega peresnika MYCLIC za injiciranje zdravila Enbrel (glejte drugo stran navodila)