natgillin/translations-raw huggingface dataset:
• Vaccinations: If possible, children should be up to date with all vaccinations before using Enbrel.
• Cepljenja: Najbolje je, da otrok pred začetkom zdravljenja z zdravilom Enbrel opravi vsa predvidena cepljenja.
Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.
Sočasna uporaba zdravila Enbrel in anakinre je bila povezana s povečanim tveganjem za pojav resnih okužb in nevtropenije v primerjavi z zdravljenjem samo z zdravilom Enbrel.
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Zdravljenje z zdravilom Enbrel lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem juvenilnega idiopatskega artritisa ali otroške psoriaze v plakih.
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Med resnimi okužbami pri bolnikih, zdravljenih z zdravilom Enbrel, so bile celulitis, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20: Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 Enbrel 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 zdravilom Enbrel, večji kot pri bolnikih, ki so prejemali placebo (ACR 20 po 3 oz. 6 mesecih: zdravilo Enbrel 62 % oz. 59 %, placebo 23 % oz. 11 %; ACR 50 po 3 oz. 6 mesecih: zdravilo Enbrel 41 % oz. 40 %, placebo 8 % oz. 5 %; p < 0,01 za zdravilo Enbrel proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
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.
Vse bolnike in starše/skrbnike je treba opozoriti, da morajo pri bolniku v primeru pojava znakov ali simptomov, ki kažejo na krvno diskrazijo ali okužbo (npr. trdovratna zvišana telesna temperatura, vnetje žrela, podplutbe, krvavitve, bledica), med zdravljenjem s tem zdravilom takoj poiskati zdravniško pomoč.
In the double-blind period, patients received Enbrel 50 mg weekly or placebo for 12 weeks.
V dvojno slepem obdobju so bolniki prejemali zdravilo Enbrel v odmerku 50 mg na teden ali placebo 12 tednov.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
Rahlo potrkajte po brizgi, da se bodo mehurčki dvignili na vrh brizge, v bližino igle (glejte sliko 8).
Patients in the Enbrel in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Pri bolnikih, ki so prejemali zdravilo Enbrel v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score) in HAQ tako po 24 kot po 52 tednih statistično pomembno večji kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji preglednici).
A single 50 mg/ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Enkratna injekcija zdravila Enbrel v odmerku 50 mg/ml je bioekvivalentna dvema sočasnima injekcijama po 25 mg/ml.
Instructions for preparing and giving an injection of Enbrel
Navodila za pripravo in dajanje injekcije zdravila Enbrel
In a polyarticular-course juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/kg twice weekly for three months.
V kliničnem preskušanju pri 69 bolnikih s poliartikularnim potekom juvenilnega idiopatskega artritisa, starih od 4 do 17 let, so injicirali 0,4 mg zdravila Enbrel/kg 2-krat tedensko v obdobju treh mesecev.
ACR 70 Month 3
ACR 70 3. mesec b
Preparing the Enbrel dose for injection d.
Priprava odmerka zdravila Enbrel za injiciranje d.
• With the needle still inserted in the vial, check the syringe for air bubbles.
Ko je igla še vedno v viali, preverite, ali so v brizgi zračni mehurčki.
Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6).
Nekajkrat nežno krožno zavrtite vialo, da se prašek raztopi (glejte sliko 6).
Enbrel is administered by subcutaneous injection.
Zdravilo Enbrel se daje s subkutano injekcijo.
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).
Pri vseh bolnikih, ki so prejemali zdravilo Enbrel, je po 104 tednih povprečna sprememba od izhodišča za rezultat SPARCC, merjen z magnetnoresonančnim slikanjem, znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
Po vseh kriterijih vprašalnika HAQ je bilo vidno izboljšanje pri bolnikih na zdravilu Enbrel v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
• Inspect the expiry dates on both the Enbrel vial label and the water for injections.
Preverite rok uporabnosti na nalepki viale zdravila Enbrel in vode za injekcije.
Step 1: Setting up for an injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of supplies
Korak 1: Priprava na injiciranje Korak 2: Izbira mesta injiciranja Korak 3: Injiciranje raztopine zdravila Enbrel Korak 4: Odstranjevanje odpadkov
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Enbrel treatment.
Vsem bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se med zdravljenjem z zdravilom Enbrel ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving Enbrel.
Pri bolnikih, ki so prejemali zdravilo Enbrel, je po 12 tednih prišlo do statistično pomembnega izboljšanja rezultata SPARCC (SPARCC - Spondyloarthritis Research Consortium of Canada; Kanadski konzorcij za raziskovanje spondilartritisa) za sakroiliakalni sklep (SIJ - Sacroiliac Joint), ki so ga merili z magnetnoresonančnim slikanjem.
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).
Viri iz obdobja trženja so poročali o kronični vnetni črevesni bolezni in uveitisu pri bolnikih z JIA, ki so se zdravili z zdravilom Enbrel, vključno z zelo majhnim številom primerov, ki kažejo na ponoven pojav bolezni ob naslednjem dajanju zdravila (glejte poglavje 4.4).
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Zdravljenje z zdravilom Enbrel lahko uvede in nadzoruje le zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, juvenilnega idiopatskega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa, radiografsko nezaznavnega aksialnega spondilartritisa, psoriaze v plakih ali otroške psoriaze v plakih.
• Infections/surgery: If the child develops a new infection, or is about to have any major surgery, the doctor may wish to monitor the child's treatment with Enbrel.
Okužbe/operacije: Če se pri otroku pojavi nova okužba ali če je pri otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel spremljati zdravljenje z zdravilom Enbrel.
When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Ko je brizga prazna, izvlecite iglo iz kože pod istim kotom, kot ste jo zabodli vanjo.
Hepat it is B reactivation, listeria
reaktivacija hepatitisa B, listerija
(n = 231) a: Patients who did not complete 12 months in the study were considered to be non-responders.
v izhodišču po 52 tednih a: Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni.
Choosing an injection site g.
Izbira mesta injiciranja h.
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose.
Če ste na predvideni odmerek zdravila Enbrel pozabili, ga morate injicirati takoj, ko se spomnite, razen če je naslednji odmerek predviden za naslednji dan.
Diagram 1 The MYCLIC pre-filled pen
Slika 1 Napolnjeni peresnik MYCLIC
In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly.
V tej študiji je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg zdravila Enbrel enkrat na teden in 153 bolnikov 25 mg zdravila Enbrel dvakrat na teden.
*Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p <0.001, b:<0.01 and c:<0.05, respectively between Enbrel and placebo
** ASAS = Mednarodno združenje za ocenjevanje spondilartritisa *** Indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa a: p < 0,001, b: < 0,01 oziroma c: < 0,05 med zdravilom Enbrel in placebom
However, your doctor may determine an alternative frequency at which to inject Enbrel.
Zdravnik vam lahko predpiše tudi drugačno pogostnost injiciranja zdravila Enbrel.
• If you are not sure how to fill your syringe ask your doctor or nurse.
Če niste prepričani, kako napolniti injekcijsko brizgo, vprašajte zdravnika ali medicinsko sestro.
Before preparing the Enbrel solution, Enbrel 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.
Pred pripravo raztopine zdravila Enbrel lahko zdravilo Enbrel shranjujete izven hladilnika pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
Previdnost je potrebna pri bolnikih, zdravljenih z zdravilom Enbrel, ki imajo krvno diskrazijo v anamnezi.
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
Obstajajo poročila iz obdobja trženja o poslabšanju KSP pri bolnikih, ki jemljejo zdravilo Enbrel, ob prisotnosti dejavnikov, ki bi lahko sprožili tako poslabšanje, in brez njih.
Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open-label 50 mg Enbrel once weekly for an additional 12 weeks.
Bolniki v tej študiji so dobivali odmerek 50 mg zdravila Enbrel ali placebo enkrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 50 mg zdravila Enbrel enkrat na teden dodatnih 12 tednov.
In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive Enbrel for up to 10 years.
Varnost uporabe zdravila so spremljali v odprtem podaljšku študije, v katerem se je 58 otrok iz zgoraj omenjene študije (v času vključitve so bili stari 4 leta ali več) z zdravilom Enbrel zdravilo do 10 let.
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with Enbrel.
• Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z zdravilom Enbrel, so poročali o primerih KVČB.
Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Pri uporabi zdravila Enbrel so poročali tudi o pojavu različnih malignih obolenj, vključno z rakom dojke, pljuč, kože in bezgavk (limfom).
For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of Enbrel per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly.
Za psoriazo pri bolnikih od 6. leta starosti naprej je običajni odmerek 0,8 mg zdravila Enbrel na kg telesne mase (do največ 50 mg), dajati pa ga je treba enkrat na teden.
Histiocytosis haematophagic (macrophage activation syndrome)†
hematofagna histiocitoza (sindrom aktivacije makrofagov)
• With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
Ko je viala z zdravilom Enbrel postavljena pokončno na ravni površini, na primer mizi, zabodite iglo brizge naravnost navzdol skozi osrednji obroč sivega zamaška viale (glejte sliko 2).
This will help reduce foaming (lots of bubbles) (see Diagram 5).
Tako boste zmanjšali penjenje raztopine (nastajanje mehurčkov) (glejte sliko 5).
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 diseasemodifying antirheumatic drug (DMARD) other than methotrexate.
V drugi dvojno slepi randomizirani študiji, nadzorovani z učinkovino, so primerjali klinično učinkovitost, varnost in radiografsko napredovanje pri bolnikih z revmatoidnim artritisom, ki so jih zdravili samo z zdravilom Enbrel (25 mg 2-krat na teden), samo z metotreksatom (7,5 do 20 mg na teden, mediani odmerek 20 mg) ali z zdravilom Enbrel in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediano trajanje 5 let) in pri katerih je bil odziv na najmanj eno od imunomodulirajočih antirevmatičnih zdravil (DMARD), razen metotreksata, manj kot zadovoljiv.
• if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
Ne uporabljajte zdravila Enbrel če ste vi ali otrok, za katerega skrbite, alergični na etanercept ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
Zdravila Enbrel se običajno ne uporablja za zdravljenje psoriaze v plakih pri otrocih, mlajših od 6 let.
• if the child you are caring for is allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
Ne uporabljajte zdravila Enbrel če je otrok, za katerega skrbite, alergičen na etanercept ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
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.
Varnost in učinkovitost 50 mg zdravila Enbrel (dve subkutani injekciji po 25 mg) enkrat na teden so ocenili v dvojno slepi, s placebom nadzorovani študiji pri 420 bolnikih z aktivnim revmatoidnim artritisom.
• 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).
• Once the solvent is added to the Enbrel, the plunger may move up by itself.
Ko je vehikel dodan zdravilu Enbrel, se lahko zgodi, da se bat brizge sam pomakne navzgor.
• Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Enbrel.
Okužbe/operacije: Če se pri vas ali otroku pojavi nova okužba ali če je pri vas ali otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel spremljati zdravljenje z zdravilom Enbrel.
However, any of the above symptoms may indicate an allergic reaction to Enbrel, so you should seek immediate medical attention.
Resne alergijske reakcije so redke, vendar pa lahko katerikoli od zgoraj navedenih simptomov kaže na pojav alergijske reakcije na zdravilo Enbrel, zato morate nemudoma poiskati zdravniško pomoč.
• 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 Enbrel.
Rak: Preden boste prejeli zdravilo Enbrel, povejte zdravniku, če imate ali ste kdaj imeli limfom (vrsta krvnega raka) ali drugo obliko raka.
In an open-label, singledose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
V odprti, enoodmerni, navzkrižni študiji pri zdravih prostovoljcih z dvema oblikama zdravljenja so ugotovili, da je enkratna injekcija 50 mg/ml etanercepta bioekvivalentna dvema sočasnima injekcijama 25 mg/ml.
In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly.
V prvem delu študije so vsi bolniki 2-krat tedensko prejemali po 0,4 mg/kg (največ 25 mg na odmerek) zdravila Enbrel subkutano.
12 Months
12 mesecev
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
V randomizirani študiji, nadzorovani z učinkovino, so s slepo radiografsko oceno kot primarnim opazovanim dogodkom primerjali učinkovitost zdravila Enbrel z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta), ki se pred tem nikoli niso zdravili z metotreksatom.
The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Za antagoniste TNF, vključno z zdravilom Enbrel, velja, da lahko vplivajo na naravno odpornost bolnika proti okužbam in malignim obolenjem, saj TNF sodeluje pri vnetju in uravnava celični imunski odziv.
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
V 24. tednu je 56 % bolnikov doseglo PASI 75 v skupini, zdravljeni z zdravilom Enbrel, v skupini s placebom pa 5 % bolnikov.
Enbrel is supplied as a solution for injection in a pre-filled pen (MYCLIC) (solution for injection).
Zdravilo Enbrel je na voljo kot raztopina za injiciranje v napolnjenem injekcijskem peresniku (MYCLIC) (raztopina za injiciranje).
Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection along with the simultaneous appearance of injection site reactions at previous injection sites.
Poleg tega so nekateri bolniki dobili tako imenovano spominsko lokalno reakcijo na mestu injiciranja; ob naslednjem injiciranju se je poleg reakcije na tedanjem mestu injiciranja sočasno pojavila reakcija tudi na prejšnjih mestih injiciranja.
Powder for solution for injection (powder for injection).
prašek za raztopino za injiciranje (prašek za injekcijo)
Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Škatlo z napolnjenimi injekcijskimi brizgami zdravila Enbrel vzemite iz hladilnika in jo odložite na ravno delovno površino.
Mean (SE) Annualized Change from Baseline in Total Sharp Score
Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto Placebo
Enbrel 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 Enbrel se lahko shranjuje pri temperaturi do največ 25 °C za enkratno obdobje do štirih tednov, po katerem se ga ne sme več ohladiti.
For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of Enbrel per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of Enbrel per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
Običajni odmerek zdravila Enbrel za zdravljenje poliartritisa ali razširjenega oligoartritisa pri bolnikih, starejših od 2 let, in za zdravljenje artritisa, povezanega z entezitisom, ali psoriatičnega artritisa pri bolnikih, starejših od 12 let, je 0,4 mg na kg telesne mase (do največ 25 mg) dvakrat na teden ali 0,8 mg na kg telesne mase (do največ 50 mg) enkrat na teden.
Some vaccines, such as oral polio vaccine, should not be given while using Enbrel.
Med zdravljenjem z zdravilom Enbrel nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
Slowly pull the plunger back to draw the liquid into the syringe (see Diagram 7).
Počasi potegnite bat nazaj, da izvlečete raztopino v brizgo (glejte sliko 7).
Your doctor may decide if you or the child need less anti-diabetic medicine while taking Enbrel.
Zdravnik lahko odloči, da boste vi ali otrok med jemanjem zdravila Enbrel potrebovali manj zdravila za zdravljenje sladkorne bolezni.
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.
V dveletnem nadzorovanem kliničnem preskušanju pri odraslih bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z zdravilom Enbrel in metotreksatom nobenih nepričakovanih ugotovitev glede varnosti; varnostni profil zdravila Enbrel pri kombiniranem zdravljenju z metotreksatom je bil podoben varnostnemu profilu, ki je bil ugotovljen pri monoterapiji z zdravilom Enbrel oziroma metotreksatom.
Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using Enbrel.
Vaš zdravnik se bo morda odločil, da bo otroka tudi po koncu zdravljenja z zdravilom Enbrel spremljal glede prisotnosti okužb.
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.
V dveletnem nadzorovanem kliničnem preskušanju pri bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z zdravilom Enbrel in metotreksatom nobenih nepričakovanih ugotovitev glede varnosti; varnostni profil zdravila Enbrel pri kombiniranem zdravljenju z metotreksatom je bil podoben varnostnemu profilu, ki je bil ugotovljen pri monoterapiji z zdravilom Enbrel oziroma metotreksatom.