natgillin/translations-raw huggingface dataset:
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).
Jednu napunjenu brizgalicu MYCLIC i jedan jastučić natopljen alkoholom (izvadite ih iz kutije s brizgalicama koju držite u hladnjaku).
In a group of 7,416 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Ukupno 18 limfoma je zabilježeno u 7416 bolesnika liječenih Enbrelom u kliničkim ispitivanjima s bolesnicima oboljelim od reumatoidnog artritisa, psorijatičkog artritisa, ankilozantnog spondilitisa i psorijaze.
At week 104, the mean change from baseline in the SPARCC score measured on MRI for all Enbrel-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
U 104. tjednu srednja vrijednost promjene od početne vrijednosti u SPARCC rezultatu mjerenom putem MRa za sve Enbrelom liječene ispitanike bila je 4,64 za sakroilijalni zglob (n=153) i 1,40 za kralježnicu (n=154).
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.
U jednom drugom otvorenom ispitivanju na jednoj skupini 60 bolesnika s oligoartritisom produljenog trajanja (15 bolesnika u dobi od 2 do 4 godine, 23 bolesnika u dobi od 5 do 11 godina i 22 bolesnika u dobi od 12 do 17 godina), 38 bolesnika s artritisom povezanim s entezitisom (u dobi od 12 do 17 godina) i 29 bolesnika s psorijatičnim artritisom (u dobi od 12 do 17 godina) bilo je liječeno Enbrelom u dozi od 0,8 mg/kg (do najviše 50 mg po dozi) tjedno tijekom 12 tjedana.
If the child has any of the above symptoms he/she may be having an allergic reaction to Enbrel, so you should seek immediate medical attention.
Međutim, bilo koji od gore navedenih simptoma u djeteta može upućivati na alergijsku reakciju na Enbrel, stoga je potrebno odmah zatražiti liječničku pomoć.
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
Djelotvornost Enbrela procijenjena je u dvostruko slijepom, placebom kontroliranom, randomiziranom ispitivanju u 211 pedijatrijskih bolesnika u dobi od 4 do 17 godina s umjerenom do teškom plak psorijazom (prema definiciji sPGA bodovanja ≥3, uključujući ≥10% BSA i PASI ≥12).
Each pack contains 4 single-dose vials and 8 alcohol swabs.
Jedno pakiranje sadrži 4 jednodozne bočice i 8 jastučića natopljenih alkoholom.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Upalne bolesti crijeva i uveitis u bolesnika s juvenilnim idiopatskim artritisom (JIA) Bilo je prijava pojave upalne bolesti crijeva i uveitisa u bolesnika s JIA liječenih Enbrelom (vidjeti dio
Diagram 16
Slika 16.
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.
Enbrel se pokazao značajno uspješnijim od placeba u svim pokazateljima odgovora prema kriterijima ACR kao i prema svim ostalim kriterijima aktivnosti reumatoidnog artritisa koji nisu obuhvaćeni kriterijima ACR, kao npr. jutarnja ukočenost.
Elevat ed liver enzymes*
Povišeni jetreni enzimi*
Cartons contain 4 vials of Enbrel, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Kutije sadrže 4 bočice Enbrela s 4 štrcaljke napunjene vodom za injekcije, 4 igle, 4 nastavka za bočice i 8 jastučića natopljena alkoholom.
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.
Nakon što izvadite napunjenu brizgalicu iz hladnjaka, pričekajte približno 15-30 minuta kako bi otopina Ebrela u brizgalici postigla sobnu temperaturu.
Immediate use is then recommended.
Tada se preporučuje odmah primijeniti Enbrel.
A biexponential curve is required to describe the concentration time curve of etanercept.
Za opis odnosa koncentracija etanercepta-vrijeme nužna je bieksponencijalna krivulja.
• The syringe and needle should NEVER be re-used.
• Štrcaljku i iglu ne smijete NIKADA ponovno koristiti.
Do not inject into areas where the skin is tender, bruised, red, or hard.
Injekciju nemojte davati na mjestu gdje je koža osjetljiva, ima modrice ili je crvena ili otvrdnula.
Diagram 15
Slika 15.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Enbrel.
• Vodene kozice: obavijestite svog liječnika ako ste Vi ili dijete bili izloženi vodenim kozicama za vrijeme primjene Enbrela.
There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with Enbrel from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Nakon stavljanja lijeka u promet prijavljeni su slučajevi upalne bolesti crijeva i uveitisa u bolesnika s juvenilnim idiopatskim artritisom koji su liječeni Enbrelom, uključujući i vrlo mali broj slučajeva ponovnog javljanja nuspojave nakon ponovne primjene lijeka (vidjeti dio 4.4).
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
U bolesnika liječenih Enbrelom prijavljeni su rijetki slučajevi pancitopenije i vrlo rijetki slučajevi aplastične anemije, ponekad sa smrtnim ishodom.
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8).
U bolesnika liječenih Enbrelom bilo je rijetkih prijava demijelinizacijskih poremećaja SŽS (vidjeti dio 4.8).
Diagram 12
Slika 12.
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.
Supkutano su davane doze od 25 mg Enbrela (na temelju ispitivanja o određivanju doze u bolesnika s reumatoidnim artritisom) odnosno placebo dva puta tjedno tijekom 6 mjeseci u 138 bolesnika.
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.
U drugom dijelu, bolesnici s kliničkim odgovorom 90. dana randomizirani su da i dalje primaju Enbrel ili placebo kroz četiri mjeseca i zatim je procijenjeni pogoršanje bolesti.
TEXT FOR PRE-FILLED SYRINGE LABEL - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
TEKST NA NALJEPNICI NAPUNJENE ŠTRCALJKE - EU/1/99/126/013-015, EU/1/99/126/026 (napunjena štrcaljka od 25 mg)
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
p-vrijednosti za usporedbu parova: * = p<0,05 za usporedbu Enbrela s metotreksatom, † = p<0,05 za usporedbu Enbrel + metotreksat u odnosu na metotreksat i  = p<0,05 za usporedbu Enbrel + metotreksat u odnosu na Enbrel.
• Very common (may affect more than 1 in 10 people):
• Vrlo često (mogu se javiti u više od 1 na 10 osoba):
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.
Profili prosječne koncentracije u serumu u stanju dinamičke ravnoteže u bolesnika liječenih zbog RA kod primjene Enbrela u dozi od 50 mg jednom tjedno (n=21) naspram primjene Enbrela u dozi od 25 mg dvaput tjedno (n=16) iznosili su Cmax od 2,4 mg/l naspram 2,6 mg/l, Cmin od 1,2 mg/l naspram 1,4 mg/l, a djelomični AUC od 297 mgh/l naspram 316 mgh/l.
However, your doctor may determine an alternative frequency at which to inject Enbrel.
Međutim, liječnik može odrediti drukčiju učestalost primjene Enbrela.
The long-term safety and effectiveness of Enbrel 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.
Nakon gore spomenutih 48 tjedana ispitivanja dugotrajna sigurnost primjene i djelotvornost Enbrela u dozi 0,8 mg/kg (do 50 mg) primijenjenog jednom tjedno procijenjena je u otvorenom produžetku ispitivanja do 2 godine u kojoj je sudjelovao 181 pedijatrijski bolesnik s plak psorijazom.
Detailed instructions on how to inject Enbrel are provided in section 7, “Using the MYCLIC pre-filled pen to inject Enbrel”.
Detaljne upute kako ubrizgati Enbrel nalaze se u dijelu 7„Uporaba napunjene brizgalice MYCLIC za ubrizgavanje Enbrela“.
Diagram 13
Slika 13.
• Inspect the expiry dates on both the vial label and the syringe label.
• Provjerite rok valjanosti na naljepnici bočice i štrcaljke.
Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Etanercept je dimer kimeričkog proteina koji se dobiva genetičkim inženjerstvom - fuzijom ekstracelularne domene receptora-2 ljudskog TNF za ligande (TNFR2/p75) s Fc domenom ljudskog IgG1.
Diagram 19
Slika 19.
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of ≥ 30 for average of duration and intensity of morning stiffness plus VAS scores of ≥ 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the
U najveće od navedenih ispitivanja (n= 277) bili su uključeni bolesnici u dobi od 18 do 70 godina koji su imali aktivni ankilozantni spondilitis definiran bodovanjem prema vizualnoj analognoj skali (VAS)  30 za prosječno trajanje i intenzitet jutarnje ukočenosti i uz VAS bodovanje
What Enbrel is and what it is used for What you need to know before you use Enbrel How to use Enbrel
Što morate znati prije nego počnete primjenjivati Enbrel Kako primjenjivati Enbrel
Mean (SE) Annualized Change from Baseline in Total Sharp Score
Srednja vrijednost (SE) godišnje promjena ukupnog rezultata na Sharpovoj ljestvici u odnosu na početnu vrijednost Placebo
A 25 mg strength of Enbrel is available for doses of 25 mg.
Za doze od 25 mg dostupna je jačina Enbrela od 25 mg.
• Chickenpox: Tell your doctor if the child is exposed to chickenpox when using Enbrel.
• Vodene kozice: obavijestite svog liječnika ako je dijete bilo izloženo vodenim kozicama za vrijeme primjene Enbrela.
Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Alternativno, 50 mg može biti primjenjivano dva puta tjedno 12 tjedana, iza čega slijedi 25 mg dva puta tjedno ili 50 mg jednom tjedno.
The safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Sigurnost i djelotvornost 50 mg Enbrela (dvije s.c. injekcije od 25 mg) jednom tjedno ispitivane su u dvostruko slijepom, placebom kontroliranom ispitivanju s 420 bolesnika s aktivnim RA.
Diagram 11
Slika 11.
Preparing the injection site and injecting the Enbrel solution
Priprema mjesta za injekciju i ubrizgavanje otopine Enbrela
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 otopina za injekciju u napunjenoj štrcaljki Štrcaljka od prozirnog stakla (staklo tipa I) s iglom od nehrđajućeg čelika, gumenim poklopcem za iglu i plastičnim klipom.
Adult patients with non-radiographic axial spondyloarthritis
Odrasli bolesnici s aksijalnim spondiloartritisom bez radiološkog dokaza
When reconstituted, the solution contains 10 mg/ml of etanercept.
Nakon pripreme otopina sadrži 10 mg/ml etanercepta.
Each vial of Enbrel 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Jedna bočica Enbrela 10 mg praška i otapala za otopinu za injekciju za pedijatrijsku primjenu sadrži 10 mg etanercepta.
Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Jedno pakiranje sadrži 4, 8 ili 24 jednodozne bočice, 4, 8 ili 24 štrcaljke napunjene vodom za injekcije, 4, 8 ili 24 igle, 4, 8 ili 24 nastavka za bočicu i 8, 16 ili 48 jastučića natopljenih alkoholom.
• When the syringe is empty, remove the needle from the skin, being careful to keep it at the same angle it was when it was inserted.
• Kada je štrcaljka prazna, izvucite iglu iz kože, pri čemu pazite da bude pod istim kutom pod kojim je bila zabodena.
Diagram 1
Slika 1.
All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, paleness) whilst on Enbrel, they should seek immediate medical advice.
Sve bolesnike i roditelje/staratelje treba savjetovati da hitno zatraže savjet liječnika ako u tijeku liječenja Enbrelom bolesnik razvije bilo kakve znakove i simptome koji upućuju na krvne diskrazije ili infekcije (npr. perzistirajuća povišena temperatura, upala grla, modrice, krvarenja, bljedilo).
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Djelotvornost Enbrela ocijenjena je u 205 bolesnika sa psorijatičnim artritisom u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
U djece i adolescenata liječenih antagonistima TNF-a, ne može se isključiti rizik razvoja zloćudnih bolesti.
8 pre-filled syringes 8 alcohol swabs
8 napunjenih štrcaljki 8 jastučića natopljenih alkoholom
4 MYCLIC pre-filled pens 4 alcohol swabs
4 napunjene brizgalice MYCLIC 4 jastučića natopljena alkoholom
Setting up for an injection
Priprema za injekciju
The Enbrel pre-filled pen is available in 25 mg and 50 mg strengths.
Enbrel napunjena brizgalica dostupna je u jačinama od 25 mg i 50 mg.
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 otopina za injekciju u napunjenoj štrcaljki Štrcaljka od prozirnog stakla (staklo tipa I) s iglom od nehrđajućeg čelika, gumenim poklopcem za iglu i plastičnim klipom.
Adding solvent e.
Dodavanje otapala e.
CARTON TEXT - EU/1/99/126/003-005
TEKST KUTIJE - EU/1/99/126/003-005
Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Pri svakoj posjeti pomoću HAQ indeksa nesposobnosti ocjenjivana je kvaliteta života u bolesnika s psorijatičnim artritisom.
Contents of the pack and other information Using the MYCLIC pre-filled pen to inject Enbrel (See overleaf)
Uporaba napunjene brizgalice MYCLIC za ubrizgavanje Enbrela (vidjeti na poleđini)
Leave the white needle cap in place and wait approximately 15-30 minutes to allow the Enbrel solution in the pen to reach room temperature.
Nemojte skinuti bijeli zatvarač igle i pričekajte 15 do 30 minuta da otopina Enbrela u brizgalici dosegne sobnu temperaturu.
Pfizer Polska Sp. z o.o.
Česká Republika Pfizer PFE spol s r.o.
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.
U četvrtom ispitivanju ocjenjivana je sigurnost primjene i djelotvornost Enbrela 50 mg (dvije s.c. injekcije od 25 mg) primijenjenog jednom tjedno naspram 25 mg Enbrela primijenjenog dva puta tjedno u dvostruko slijepom, placebom kontroliranom ispitivanju u 356 bolesnika s aktivnim ankilozantnim spondilitisom.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Djelotvornost Enbrela ispitivana je u randomiziranom, dvostruko-slijepom placebom kontroliranom ispitivanju.
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.
U četvrtom ispitivanju ocjenjivana je sigurnost primjene i djelotvornost Enbrela 50 mg (dvije s.c. injekcije od 25 mg) primijenjenog jednom tjedno naspram 25 mg Enbrela primijenjenog dva puta tjedno, u dvostruko slijepom, placebom kontroliranom ispitivanju u 356 bolesnika s aktivnim ankilozantnim spondilitisom.
Diagram 9
Slika 9.
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.
Među bolesnicima s ankilozantnim spondilitisom koji su primali Enbrel, klinički odgovor bio je očit u trenutku prvog kontrolnog pregleda (nakon 2 tjedna), a zadržan je i tijekom trajanja terapije od 6 mjeseci.
• Wipe the site where Enbrel is to be injected with a new alcohol swab, using a circular motion.
• Obrišite mjesto uboda gdje će se ubrizgati Enbrel novim jastučićem vate natopljene alkoholom, kružnim pokretom.
MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.
Provedena su MR snimanja sakroilijakalnog zgloba i kralježnice kako bi se procijenila upala na početku i u 12. i 104. tjednu.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject Enbrel."
Iscrpne upute za primjenu nalaze se u uputi o lijeku, dio 7 “Uporaba napunjene brizgalice MYCLIC za ubrizgavanje Enbrela”.
2 MYCLIC pre-filled pens 2 alcohol swabs
2 napunjene brizgalice MYCLIC 2 jastučića natopljena alkoholom
Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Odgovori su bili slični u bolesnika bez obzira na to jesu li ishodišno primali prateću terapiju.
28b a: p<0.001, Enbrel vs. placebo b: p = 0.002, Enbrel vs. placebo
ASAS 70 2 tjedna 3 mjeseca 6 mjeseci a: p<0,001, Enbrel u odnosu na placebo b: p = 0,002, Enbrel u odnosu na placebo
Start again with another vial.
Ponoviti postupak s novom bočicom.
Enbrel 25 mg injection etanercept
Enbrel 25 mg injekcija etanercept
Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Kutija sadrži 4 bočice Enbrela i 8 jastučića natopljenih alkoholom.
Wipe the site where Enbrel is to be injected with the alcohol swab, using a circular motion.
Obrišite mjesto uboda gdje će se ubrizgati Enbrel jastučićem vate natopljene alkoholom, kružnim pokretom.
CARTON TEXT - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
TEKST KUTIJE - EU/1/99/126/013-015, EU/1/99/126/026 (napunjena štrcaljka od 25 mg)
In a controlled clinical trial of two years duration in adult rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
U kontroliranom kliničkom ispitivanju odraslih bolesnika s reumatoidnim artritisom u trajanju od dvije godine nisu nađeni neočekivani učinci kombinacije Enbrela i metotreksata s obzirom na sigurnost primjene te je sigurnosni profil Enbrela davanog u kombinaciji s metotreksatom bio sličan onima koji su opisani u ispitivanjima samo s Enbrelom, odnosno samo s metotreksatom.
• With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level.
• Dok je štrcaljka još spojena s bočicom i nastavkom za bočicu, držite bočicu u razini očiju tako da bude okrenuta naopako.
Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
Pri liječenju Enbrelom potreban je oprez u bolesnika u kojih u anamnezi postoji pojava krvnih diskrazija.
CARTON TEXT - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
TEKST KUTIJE - EU/1/99/126/016-018 (napunjena štrcaljka od 50 mg)
In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
U kontroliranom kliničkom ispitivanju u bolesnika s reumatoidnim artritisom u trajanju od dvije godine nisu nađeni neočekivani učinci kombinacije Enbrela i metotreksata s obzirom na sigurnost primjene te je sigurnosni profil Enbrela davanog u kombinaciji s metotreksatom bio sličan onima koji su opisani u ispitivanjima samo s Enbrelom, odnosno samo s metotreksatom.
Musculoskeleta l and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva
CARTON TEXT - EU/1/99/126/022 (For paediatric use)
POSUDE - EU/1/99/126/022 (za pedijatrijsku primjenu)
The syringe and needle should NEVER be re-used.
Ne smijete NIKADA ponovno koristiti štrcaljku i iglu.
• Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Enbrel.
• Hepatitis B: obavijestite svog liječnika ako Vi ili dijete imate ili ste ikad imali hepatitis B.
Sucrose, sodium chloride, L-arginine hydrochloride, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate and water for injections.
Saharoza, natrijev klorid, L-argininklorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat i voda za injekcije.
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.
Među bolesnicima s plak psorijazom koji su primali Enbrel zabilježen je značajan odgovor u usporedbi s placebom već za vrijeme prvog posjeta (nakon 2 tjedna) koji se održao do kraja 24. tjedna terapije.