natgillin/translations-raw huggingface dataset:
Benepali is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Zdravilo Benepali ni indicirano za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg.
• Do not remove the needle cap until you are ready to inject.
• Z igle ne odstranite pokrovčka, dokler niste pripravljeni na injiciranje.
Dispose of the entire syringe in an approved sharps container.
Celo prazno iglo odstranite v odobren vsebnik za ostre odpadke.
• Do not use the pre-filled pen if it has been dropped onto a hard surface.
• Ne uporabljajte napolnjenega injekcijskega peresnika, če je padel na trdo površino.
The Benepali pre-filled syringe is for a subcutaneous injection.
Napolnjen injekcijski peresnik z zdravilom Benepali je za subkutano injiciranje.
In study 1, the etanercept-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 etanerceptom (30 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
Sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injections.
saharoza, natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, voda za injekcije.
Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Bolezni dihal, prsnega koša in mediastinalne ga prostora intersticijska bolezen pljuč (vključno s pnevmonitisom in pljučno fibrozo)*
• Very common (may affect more than 1 in 10 people):
• Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Patients received etanercept 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Bolniki so 12 tednov enkrat na teden prejemali etanercept v odmerku 0,8 mg/kg (do 50 mg) ali placebo.
CNS demyelinating cases suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Bolezni živčevja demielinizirajoči primeri 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 Guillain
Histiocytosis haematophagic (macrophage activation syndrome)*
(sindrom aktivacije makrofagov) *
After taking a syringe or a pen from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe or the pen to reach room temperature.
Ko napolnjeno injekcijsko brizgo ali peresnik vzamete iz hladilnika, počakajte približno 30 minut, da se raztopina zdravila Benepali v brizgi ali peresniku segreje na sobno temperaturo.
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept.
Pri bolnikih, ki so bili zdravljeni z etanerceptom, so poročali o redkih primerih pancitopenije in zelo redkih primerih aplastične anemije, tudi s smrtnim izidom.
Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Študija 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki,
Inflammatory bowel disease
Bolezni prebavil vnetna črevesna bolezen
Among patients with psoriatic arthritis who received etanercept, 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 etanercept, so bili klinični odzivi vidni že pri prvem obisku (po 4 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
Benepali is available in packs containing 4 pre-filled syringes, multipacks containing 8 (2 packs of 4) pre-filled syringes and multipacks containing 24 (6 packs of 4) pre-filled syringes.
Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, večodmerno pakiranje, ki vsebuje 8 (2 pakiranji po 4) napolnjenih injekcijskih brizg in večodmerno pakiranje, ki vsebuje 24 (6 pakiranj po 4) napolnjenih injekcijskih brizg.
• Rare (may affect up to 1 in 1,000 people):
• Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
Inspect the solution: Look at the medicine through the viewing window.
Zdravilo preglejte skozi okence za pregledovanje.
Allergic reactions associated with etanercept administration have been reported commonly.
V povezavi z uporabo etanercepta so pogosto poročali o alergijskih reakcijah.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Pri bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je odziv PASI 75 med
Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received etanercept without interruption.
Dolgotrajna odzivnost na neprekinjeno zdravljenje z etanerceptom je bila v odprtih podaljšanih kliničnih preskušanjih potrjena za obdobja do 10 let.
50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
50 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Ena napolnjen injekcijski peresnik vsebuje 50 mg etanercepta.
• Very rare (may affect up to 1 in 10,000 people):
• Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
Psoriatic Arthritis Response
Odziv psoriatičnega artritisa
In study 4, the etanercept-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 etanerceptom (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
In part 2, patients with a clinical response at day 90 were randomised to remain on etanercept or receive placebo for four months and assessed for disease flare.
V drugem delu študije pa so bolnike s kliničnim odzivom na etanercept na 90. dan randomizirali v dve podskupini: ena je nadaljevala zdravljenje z etanerceptom, druga pa je nadaljnje štiri mesece prejemala placebo - pri obeh so ocenjevali ponoven izbruh bolezni.
Placebo (N = 105)
(n = 105)
Allow the medicine to reach room temperature: Remove one pre-filled syringe from the refrigerator and leave at room temperature for at least 30 minutes before injecting.
Iz hladilnika vzemite eno napolnjeno injekcijsko brizgo in jo pustite na sobni temperaturi vsaj 30 minut pred injiciranjem.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Benepali.
• Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom Benepali izpostavljeni noricam.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 mg/1 ml
Name and address of the manufacturer responsible for batch release Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Ime in naslov izdelovalca, odgovornega za sproščanje serij Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
V kliničnih študijah zdravljenja z etanerceptom, ki so trajale približno 2 leti in so vključevale 240 bolnikov s psoriatičnim artritisom, so poročali o 2 primerih malignega obolenja.
Solution for injection Multipack: 12 (3 packs of 4) pre-filled syringes
Večodmerno pakiranje: 12 (3 pakiranja s 4) napolnjenimi injekcijskimi peresniki
Solution for injection 4 pre-filled syringes
raztopina za injiciranje 4 napolnjene injekcijske brizge
Baseline Week 52
52. teden
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Benepali 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 Benepali skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
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 etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
Odstotek bolnikov brez napredovanja (sprememba TSS ≤ 0,5) je bil po 24 mesecih večji v skupini, ki je dobivala etanercept v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali etanercept ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
Among patients with ankylosing spondylitis who received etanercept, 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 etanercept, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali vseh 6 mesecev zdravljenja.
Some vaccines, such as oral polio vaccine, should not be given while using Benepali.
Med zdravljenjem z zdravilom Benepali nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
No study has been performed in patients with psoriatic arthritis using the 50 mg once-weekly dosing regimen.
Pri bolnikih s psoriatičnim artritisom klinične študije z režimom odmerjanja 50 mg enkrat na teden niso izvedli.
• Do not use heat sources, such as a microwave or hot water, to warm Benepali.
• Za ogrevanje zdravila Benepali ne uporabljajte virov toplote.
Among patients with plaque psoriasis who received etanercept, 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 etanercept, je bil pomemben odziv v primerjavi s placebom opazen na prvem pregledu (po 2 tednih) in se je ohranil skozi 24 tednov zdravljenja.
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 kakršnega koli razloga izpadli iz študije, obravnavali, kot da jim je bolezen napredovala.
2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
39 otrok je bilo starih od 2 do 3 leta.
A.
Ab,
Renal and hepatic impairment No dose adjustment is required.
Pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis like ankylosis.
Starost bolnikov je bila od 18 do 70 let in vsi so imeli aktivni psoriatični artritis (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) v najmanj eni od naslednjih oblik: (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (25 mg PRE-FILLED SYRINGE)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (25 mg NAPOLNJENA INJEKCIJSKA BRIZGA)
After taking a syringe from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe to reach room temperature.
Ko napolnjeno injekcijsko brizgo vzamete iz hladilnika, počakajte približno 30 minut, da se raztopina zdravila Benepali v brizgi segreje na sobno temperaturo.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept 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 enteracepta pri odraslih bolnikih z revmatoidnim artritisom.
Etanercept 0.8 mg/kg Once Weekly (N = 106)
0,8 mg/kg enkrat na teden
Τηλ: + 357 22 00 04 93
Genesis Pharma S.A. Τηλ: + 357 22 00 04 93
Elevated liver enzymes*
žolčnika in žolčevodov zvišane vrednosti jetrnih encimov*
The recommended dose of etanercept is 50 mg administered once weekly.
Priporočeni odmerek je 50 mg etanercepta enkrat na teden.
Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept.
Pri bolnikih, zdravljenih z etanerceptom, so poročali o primerih aktivne tuberkuloze, vključno z miliarno tuberkulozo in ekstrapulmonarno tuberkulozo.
Firmly press the pre-filled pen down into the site to start the injection.
Za začetek injiciranja čvrsto pritisnite napolnjen injekcijski peresnik na mesto injiciranja.
Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy.
Nosečnost in dojenje Ženskam v rodni dobi je treba svetovati, naj uporabljajo ustrezno kontracepcijo, da med zdravljenjem z zdravilom Benepali in še tri tedne po njem ne zanosijo.
Rotate the site for each injection.
Za vsako injiciranje izberite drugo mesto.
Serious and fatal infections have been reported during use of etanercept; 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.
Women using Benepali should not breast-feed, since Benepali passes into human breast milk.
Zdravilo Benepali prehaja v materino mleko, zato bolnice med zdravljenjem z zdravilom Benepali ne smejo dojiti.
Pancytopenia* Aplastic anaemia*
aplastična anemija*
Keep the pre-filled syringes or pens in the outer carton in order to protect from light.
Shranjujte v napolnjeni injekcijski brizgi ali peresniku v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Benepali is available in packs containing 4 pre-filled syringes, multipacks comprising 2 cartons, each containing 4 pre-filled syringes and multipacks comprising 6 cartons, each containing 4 pre-filled syringes.
Zdravilo Benepali je na voljo v pakiranjih, ki vsebujejo 4 napolnjene injekcijske brizge, večodmernih pakiranjih, ki vsebujejo 2 škatli, od katerih vsaka vsebuje 4 napolnjene injekcijske brizge in večodmernih pakiranjih, ki vsebujejo 6 škatel, od katerih vsaka vsebuje 4 napolnjene injekcijske brizge.
A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Pri otrocih z juvenilnim idiopatskim artritisom, ki imajo telesno maso manjšo od 25 kg, bo morda primernejša uporaba 10 mg viale.
Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
bakterijskim artritisom, sepso in parazitsko okužbo)*
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.
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).
Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Benepali in patients who have congestive heart failure (CHF).
Zdravniki morajo biti previdni, kadar predpišejo zdravilo Benepali bolnikom s kongestivnim srčnim popuščanjem (KSP).
Benepali 50 mg injection etanercept
Benepali 50 mg injekcija etanercept s.c.
Please ask your doctor if you have any questions about this.
Če imate v tej zvezi kakršna koli vprašanja, se posvetujte z zdravnikom.
• Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness.
• Bolezni krvi: Če se pri vas ali otroku pojavi kateri koli od znakov ali simptomov, kot so trdovratna vročina, vnetje žrela, podplutbe na koži, krvavitve ali bledica, se nemudoma posvetujte s svojim zdravnikom.
Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal antiinflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ali prednizona (< 0,2 mg/kg/dan ali največ 10 mg).
There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
Etanercepta se običajno ne uporablja za zdravljenje juvenilnega idiopatskega artritisa pri otrocih,
Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Pri nekaterih bolnikih, ki so prejemali zdravilo Benepali, se je pojavil kožni rak. Povejte zdravniku, če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNFantagonists, including etanercept.
Pri bolnikih, zdravljenih z antagonisti TNF, vključno z etanerceptom, so poročali o melanomu in nemelanomskem kožnem raku (NMSC- Non-Melanoma Skin Cancer).
Antibodies to etanercept
Protitelesa proti etanerceptu
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.
Alternativno je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 25 mg dvakrat na teden ali odmerek 50 mg enkrat na teden.
In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled 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 etanercepta v odmerku 50 mg enkrat na teden (dve 25 mg subkutani injekciji) v primerjavi z dajanjem etanercepta v odmerku 25 mg dvakrat na teden.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (50 mg 2 PRE-FILLED SYRINGES) WITHOUT BLUE BOX
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA (50 mg 2 NAPOLNJENI INJEKCIJSKI BRIZGI) BREZ BLUE BOX
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received etanercept.
15.402 bolnikih, ki so prejeli etanercept, 0,09 %.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Rezultati po 12 tednih pri pediatričnih bolnikih s psoriazo v plakih
Paediatric plaque psoriasis
Pediatrična psoriaza v plakih
Name and address of the manufacturer of the biological active substance Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Keep the pre-filled syringes in the outer carton in order to protect from light.
Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 50 mg once weekly.
Alternativno je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 50 mg enkrat na teden.
Treatment with Benepali may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
B, lahko zdravljenje z zdravilom Benepali povzroči ponoven zagon hepatitisa B. V takšnem primeru morate zdravilo Benepali prenehati uporabljati.
Benepali 25 mg injection etanercept
Benepali 25 mg injekcija etanercept s.c.
Patient Alert Card Benepali Etanercept
Benepali etanercept
For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
HBV, je priporočljivo posvetovanje z zdravnikom specialistom za zdravljenje hepatitisa B. Pri dajanju zdravila Benepali bolnikom, ki so že bili okuženi s HBV, je potrebna previdnost.
Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Water for injections
6.1 Seznam pomožnih snovi saharoza natrijev klorid natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat heptahidrat voda za injekcije
A single-use pre-filled syringe contains one 25 mg dose of Benepali.
Napolnjena injekcijska brizga za enkratno uporabo vsebuje en 25-mg odmerek zdravila Benepali.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 12 (3 PACKS OF 4 PRE-FILLED SYRINGES) (WITH BLUE BOX)
VEČODMERNO PAKIRANJE Z 12 (3 PAKIRANJA S PO 4 NAPOLNJENIMI INJEKCIJSKIMI PERESNIKI) (Z BLUE BOX)
Solution for injection 4 pre-filled pens
raztopina za injiciranje 4 napolnjeni injekcijski peresniki
For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly.
Za psoriazo pri bolnikih od 6. leta starosti naprej in s telesno maso 62,5 kg ali več je običajni odmerek
C. Injection site care
C. Nega mesta injiciranja
Neoplasms benign, malignant and
demielinizirajočo polinevropatijo in multifokalno
In this study, most psoriatic arthritis patients receiving etanercept were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving etanercept.
Večina bolnikov s psoriatičnim artritisom, ki so dobivali etanercept, je v tej študiji zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
Immune system disorders
Bolezni imunskega sistema alergijske reakcije
The side effects and their frequencies seen in children and adolescents are similar to those described above.
Neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri otrocih in mladostnikih so bili po vrsti in pogostnosti podobni neželenim učinkom,
Benepali 25 mg solution for injection in pre-filled syringe.
Benepali 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi