FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Icelandic: Alvarlegar sýkingar hjá sjúklingum sem meðhöndlaðir voru með Enbrel voru meðal annars húðbeðsbólga, maga- og garnabólga, lungnabólga, gallblöðrubólga, bein- og mergbólga, magabólga, botnlangabólga, fellsbólga af völdum streptókokka, vöðvaþroti, sýklasóttarlost, sarpbólga og ígerð.
English: 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).
Icelandic: Eftir markaðssetningu hefur verið greint frá bólgusjúkdómi í þörmum og æðahjúpsbólgu hjá sjúklingum með sjálfvakta barnaliðagigt sem fengu Enbrel meðferð, þar með talin örfá tilfelli þar sem reynt var að gefa lyfið aftur eftir hlé á lyfjagjöf (sjá kafla 4.4).
English: Cartons contain 4, 8 or 24 vials of Enbrel with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Icelandic: Hver askja inniheldur 4, 8 eða 24 Enbrel hettuglös, 4, 8 eða 24 áfylltar sprautur með leysi, 4, 8 eða 24 nálar, 4, 8 eða 24 millistykki á hettuglös og 8, 16 eða 48 sprittklúta.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using Enbrel.
Icelandic: Ef mögulegt er, skal öllum bólusetningum vera lokið á réttum tíma áður en barnið notar Enbrel.
English: 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.
Icelandic: Lausnin skal vera tær eða örlítið mjólkurlituð, litlaus til ljósgul eða ljósbrún og hún kann að innihalda litlar hálfgagnsæjar eða hvítar próteinagnir.
English: Elevat ed liver enzymes*
Icelandic: Hækkuð lifrarensím* Sjálfsnæmislifrarb ólga*
English: Doses of 10 mg or 25 mg Enbrel were administered SC twice a week for up to 24 months.
Icelandic: Skammtarnir 10 eða 25 mg voru gefnir undir húð tvisvar í viku í allt að 24 mánuði.
English: Slovenija Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
Icelandic: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
English: The dosage of Enbrel is based on body weight for paediatric patients.
Icelandic: Enbrel skammtar fyrir börn eru byggðir á líkamsþyngd.
English: EU/1/99/126/013 4 pre-filled syringes EU/1/99/126/014 8 pre-filled syringes EU/1/99/126/015 24 pre-filled syringes EU/1/99/126/026 12 pre-filled syringes
Icelandic: EU/1/99/126/013 4 áfylltar sprautur EU/1/99/126/014 8 áfylltar sprautur EU/1/99/126/015 24 áfylltar sprautur EU/1/99/126/026 12 áfylltar sprautur
English: EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
Icelandic: EU/1/99/126/016 2 áfylltar sprautur EU/1/99/126/017 4 áfylltar sprautur EU/1/99/126/018 12 áfylltar sprautur
English: 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 an sPGA
Icelandic: Virkni Enbrel var metin með slembiraðaðri, tvíblindri samanburðarrannsókn við lyfleysu þar sem 211 börn á aldrinum 4 -17 ára með meðalsvæsinn til svæsinn skellupsoriasis (skilgreint með sPGA stigafjölda ≥ 3 sem felur í sér ≥ 10% af BSA (yfirborðsflatarmáli líkamans) og PASI ≥ 12).
English: • Instructional materials to share with patients
Icelandic: Viðhafa skal varúð hjá sjúklingum
English: Comprehensive instructions for administration are given in the package leaflet, section 7, “Using the MYCLIC pre-filled pen to inject Enbrel.”
Icelandic: Ítarlegar leiðbeiningar um lyfjagjöf eru gefnar í fylgiseðli, kafla 7, „Notkun MYCLIC áfyllta lyfjapennans til inndælingar á Enbrel“.
English: Do not mix the Enbrel solution with any other medicine.
Icelandic: Enbrel lausninni við önnur lyf.
English: 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
Icelandic: Mergslíðurssviptin g í miðtaugakerfi sem bendir til heila- og mænusiggs eða staðbundin mergslíðurssviptin g eins og sjóntaugarþroti og þverrofsmænubólg a (transverse myelitis) (sjá kafla 4.4), mergslíðurssviptin g í úttaugakerfi, þ.m.t. GuillainBarré heilkenni, krónískur bólgumyndandi fjöltaugakvilli með mergslíðurssviptin gu, fjöltaugakvilli með mergslíðurssviptin gu og fjölhreiðra hreyfitaugakvilli (sjá kafla 4.4), flog
English: Enbrel 25 mg solution for injection in pre-filled syringe Enbrel 50 mg solution for injection in pre-filled syringe
Icelandic: Enbrel 25 mg stungulyf, lausn í áfylltri sprautu Enbrel 50 mg stungulyf, lausn í áfylltri sprautu
English: Methotrexate
Icelandic: Sýkingar
English: Detailed instructions on how to prepare and inject Enbrel are provided in section 7, “Instructions for preparing and giving an injection of Enbrel”.
Icelandic: Ítarlegar upplýsingar um hvernig á að undirbúa og sprauta Enbrel eru gefnar í kafla 7, „Leiðbeiningar fyrir undirbúning og gjöf á Enbrel stungulyfi“.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
Icelandic: Pör borin saman, p-gildi: † = p < 0,05 þegar Enbrel + metótrexat er borið saman við metótrexat  = p < 0,05 þegar Enbrel + metótrexat er borið saman við Enbrel
English: CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
Icelandic: TEXTI Á ÖSKJU - EU/1/99/126/019-0021 (50 mg áfylltur lyfjapenni)
English: Remissionc
Icelandic: Rénun
English: Enbrel 25 mg solution for injection in pre-filled syringe EU/1/99/126/013
Icelandic: Enbrel 25 mg stungulyf, lausn í áfylltri sprautu EU/1/99/126/013
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TEXT FOR PRE-FILLED SYRINGE - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Icelandic: TEXTI FYRIR MERKINGU Á ÁFYLLTA SPRAUTU- EU/1/99/126/016-018 (50 mg áfyllt sprauta)
English: 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.
Icelandic: Litlaus sprauta úr gleri (gler af tegund I) með nál úr ryðfríu stáli, nálarhettu úr gúmmíi og plastbullu.
English: Look for the needle tip inside the stopper window (see Diagram 3).
Icelandic: Athugaðu hvort nálin sjáist í gegnum raufina á tappanum (sjá mynd 3).
English: Physicians should use caution when using Enbrel in patients who also have moderate to severe alcoholic hepatitis.
Icelandic: Enbrel er notað fyrir sjúklinga sem eru líka með frekar svæsna eða svæsna lifrarbólgu vegna áfengisneyslu.
English: Choosing an injection site g.
Icelandic: Val á stungustað g.
English: Enbrel 50 mg solution for injection in pre-filled syringe EU/1/99/126/016
Icelandic: Enbrel 50 mg stungulyf, lausn í áfylltri sprautu EU/1/99/126/016
English: Antibodies to Enbrel
Icelandic: Mótefni gegn Enbrel
English: What you need to know before you use Enbrel
Icelandic: Áður en byrjað er að nota Enbrel
English: 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.
Icelandic: Í klínískri rannsókn sem stóð yfir í tvö ár á sjúklingum með iktsýki sem voru á samsettri meðferð með Enbrel og metótrexati kom ekkert óvænt fram er varðar öryggi meðferðarinnar.
English: Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Icelandic: Samkvæmt niðurstöðum úr opinni rannsókn, var sama svörun við Enbrel hjá sjúklingum sem hófu meðferð að nýju eftir allt að 24 mánaða hlé og hjá sjúklingum sem höfðu fengið samfellda meðferð með Enbrel.
English: 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.
Icelandic: klst./l og hjá iktsýkisjúklingum á meðferð með 25 mg Enbrel tvisvar í viku (n=16) var Cmax 2,6 mg/l, Cmin 1,4 mg/l og AUC var 316 mg•klst./l. Í opinni, stakskammta víxlunarrannsókn (crossover study) á heilbrigðum sjálfboðaliðum í tveimur meðhöndlunarhópum kom fram að etanercept 50 mg/ml inndæling í eitt skipti jafngilti tveimur samtímis inndælingum með 25 mg/ml.
English: Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Enbrel in patients who have congestive heart failure (CHF).
Icelandic: Læknum ber að gæta varúðar við notkun Enbrel hjá sjúklingum sem hafa hjartabilun.
English: In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Icelandic: Enbrel hjá sjúklingum sem þróa með sér lifrarbólguveiru B sýkingu og hefja viðeigandi veirulyfjameðferð ásamt stuðningsmeðferð eftir því sem við á.
English: Pregnancy and breast-feeding
Icelandic: Sæfða sprautu og nálar
English: Preparing the Enbrel dose for injection
Icelandic: Enbrel lausnin dregin úr hettuglasinu upp í sprautuna
English: 39.8% †,φ
Icelandic: 0,79-1,90, leiðrétt áhættuhlutfall =
English: Adding solvent
Icelandic: HEITI LYFS
English: CARTON TEXT - EU/1/99/126/022 (For paediatric use)
Icelandic: TEXTI Á ÖSKJU - EU/1/99/126/022 (Til notkunar fyrir börn)
English: • With the needle still in the vial, hold the vial upside down at eye level.
Icelandic: Á meðan sprautan er enn í hettuglasinu er því hvolft og haldið lóðrétt í augnhæð.
English: Clinical improvement, including onset of action within 2 weeks with Enbrel 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months.
Icelandic: Bati var í samræmi við niðurstöður úr fyrri rannsóknum og hélst í allt að 24 mánuði og Enbrel 25 mg byrjaði að verka innan tveggja vikna.
English: 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.
Icelandic: Meðalþéttni í sermi við jafnvægi hjá iktsýkisjúklingum í meðferð með 50 mg Enbrel einu sinni í viku (n=21) var Cmax 2,4 mg/l, Cmin 1,2 mg/l og AUC var 297 mg•
English: The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Icelandic: Ráðlagður skammtur er 25 mg Enbrel gefið tvisvar í viku eða 50 mg gefin einu sinni í viku.
English: EU/1/99/126/003 4 vials EU/1/99/126/004 8 vials EU/1/99/126/005 24 vials
Icelandic: EU/1/99/126/003 - 4 hettuglös EU/1/99/126/004 - 8 hettuglös EU/1/99/126/005 - 24 hettuglös
English: 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).
Icelandic: Bólgusjúkdómur í þörmum og æðahjúpsbólga hjá sjúklingum með sjálfvakta barnaliðagigt Greint hefur verið frá bólgusjúkdómi í þörmum og æðahjúpsbólgu hjá sjúklingum með sjálfvakta barnaliðagigt sem fengu meðferð með Enbrel (sjá kafla 4.8).
English: Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.
Icelandic: Eftir 24 mánuði kom einnig í ljós marktækur yfirburður Enbrel í samsettri meðferð með metótrexati, samanborið við einlyfjameðferð með Enbrel eða metótrexati.
English: One hundred and twenty-nine new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
Icelandic: á Enbrel sem stóðu yfir í allt að um það bil 6 ár, þar með talinn 231 sjúklingur sem fékk samsetta meðferð með Enbrel og metótrexati í 2 ára rannsókn þar sem borið var saman við virka meðferð.
English: The known side effects of Enbrel include the following in groups of decreasing frequency:
Icelandic: Meðal þekktra aukaverkana Enbrel eru eftirtaldar, þær algengustu eru taldar fyrst:
English: In a group of 2,711 plaque psoriasis patients treated with Enbrel in doubleblind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.
Icelandic: Skráð hafa verið sex tilfelli illkynja sjúkdóma hjá þeim 351 sjúklingum með hryggikt sem meðhöndlaðir voru með Enbrel, í klínískri rannsókn sem stóð yfir í meira en tvö ár. Greint hefur verið frá 30 tilfellum illkynja meina og 43 tilfellum krabbameina í húð sem ekki voru sortuæxli í hópi 2.711 sjúklinga með skellupsoriasis sem fengu
English: Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Icelandic: Hver pakkning inniheldur 2, 4 eða 12 áfylltar sprautur og 2, 4 eða 12 sprittklúta.
English: Treatment with Enbrel may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Icelandic: B sýkingu er mælt með að samráð sé haft við lækni með sérþekkingu á meðferð lifrarbólgu B. Gæta skal varúðar þegar Enbrel er gefið sjúklingum sem hafa áður sýkst af lifrarbólguveiru B. Fylgjast skal með þessum sjúklingum hvað varðar einkenni virkrar lifrarbólguveiru
English: Cartons contain 4 vials of Enbrel with 8 alcohol swabs.
Icelandic: 4 Enbrel hettuglös og 8 sprittklúta.
English: Each MYCLIC pre-filled pen contains 25 mg of etanercept.
Icelandic: Hver MYCLIC áfylltur lyfjapenni inniheldur 25 mg af etanercept.
English: Each pre-filled syringe of Enbrel contains 50 mg etanercept.
Icelandic: Hver áfyllt sprauta af Enbrel inniheldur 50 mg etanercept.
English: 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).
Icelandic: Enbrel er afhent sem áfyllt sprauta með tærri, litlausri til ljósgulri eða ljósbrúnni lausn til inndælingar (stungulyf, lausn).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT - EU/1/99/126/002
Icelandic: TEXTI FYRIR SKAMMTABAKKA - EU/1/99/126/002
English: Infect ions and infestations
Icelandic: LYFJAFORM OG INNIHALD
English: Powder: Mannitol (E421), sucrose and trometamol Solvent: Water for injections
Icelandic: Stungulyfsstofn: Mannitól (E421), súkrósi og trómetamól
English: Each pack contains 4, 8, 12 or 24 pre-filled syringes and 4, 8, 12 or 24 alcohol swabs.
Icelandic: Hver askja inniheldur 4, 8. 12 eða 24 áfylltar sprautur með Enbrel og 4, 8, 12 eða 24 sprittklúta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACKING - EU/1/99/126/002
Icelandic: TEXTI FYRIR MERKINGU Á HETTUGLAS - EU/1/99/126/002
English: Enbrel 25 mg powder for solution for injection
Icelandic: Enbrel 25 mg stungulyf, lausn í áfylltri sprautu
English: Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Icelandic: ASAS 20, ASAS 50 og ASAS 70 strax eftir 2 vikna meðferð.
English: In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident.
Icelandic: Enbrel var ekki hægt að ákveða þann skammt sem orsakaði eituráhrif og ekki var hægt að sýna fram á eituráhrif í einstökum líffærum.
English: Enbrel is administered by subcutaneous injection.
Icelandic: Enbrel er gefið með inndælingu undir húð.
English: Again, do not touch the needle or allow it to touch any surface.
Icelandic: Gættu þess að snerta ekki nálina eða að nálin komist í snertingu við neitt.
English: Enbrel 25 mg solution for injection in pre-filled pen EU/1/99/126/023
Icelandic: Enbrel 25 mg stungulyf, lausn í áfylltum lyfjapenna EU/1/99/126/023
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Icelandic: Ítarlegar leiðbeiningar um lyfjagjöf Enbrel eru gefnar í fylgiseðli, kafla 7, „Leiðbeiningar fyrir undirbúning og gjöf á Enbrel stungulyfi“.
English: A 25 mg strength of Enbrel is available for doses of 25 mg.
Icelandic: Enbrel í 25 mg styrkleika er fáanlegt fyrir 25 mg skammta (eða minni).
English: Each vial of Enbrel contains 25 mg etanercept.
Icelandic: Hvert hettuglas af Enbrel inniheldur 25 mg etanercept.
English: Enbrel 50 mg solution for injection in pre-filled pen EU/1/99/126/019
Icelandic: Enbrel 50 mg stungulyf lausn, í áfylltum lyfjapenna EU/1/99/126/019
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 11).
Icelandic: Þrýstu síðan á stimpilinn til þess að sprauta inn lausninni hægt og með jöfnum hraða (sjá mynd 11).
English: Cartons contain 4, 8, 12 or 24 pre-filled syringes of Enbrel and 4, 8, 12 or 24 alcohol swabs.
Icelandic: 4, 8, 12 eða 24 áfylltar sprautur og 4, 8, 12 eða 24 sprittklúta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TEXT FOR TRAY BACKING - EU/1/99/126/003-005
Icelandic: TEXTI FYRIR MIÐA Á HETTUGLAS - EU/1/99/126/003-005
English: Enbrel 50 mg solution for injection in pre-filled syringe etanercept
Icelandic: Enbrel 50 mg stungulyf, lausn í áfylltri sprautu etanercept
English: 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.
Icelandic: Enbrel var klínísk svörun augljós í fyrsta viðtalstímanum (4 vikur) og viðhélst alla meðhöndlunina þ.e.a.s. í 6 mánuði.
English: 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.
Icelandic: Enbrel var verulega betra en lyfleysa í öllum þáttum sem ACR mælikvarðinn tekur til, sem og öðrum þáttum iktsýki sem ACR tekur ekki tillit til, svo sem morgunstirðleika.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p<0.05).
Icelandic: Í greiningu þar sem allir sjúklingar sem hættu í rannsókninni, af hvaða ástæðu sem er, voru metnir sem þeim hefði versnað, var hlutfall sjúklinga sem ekki versnaði (TSS breyting ≤ 0,5) eftir 24 mánuði, hærra hjá þeim sem fengu
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject Enbrel."
Icelandic: Leiðbeiningar um gjöf má sjá í kafla 7 í fylgiseðli „Notkun MYCLIC áfyllta lyfjapennans til inndælingar á Enbrel“.
English: • Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Icelandic: Enbrel er ekki ætlað til notkunar á Wegener hnúðabólgum, sjaldgæfum bólgusjúkdómi.
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use etanercept
Icelandic: Enbrel 10 mg stungulyfsstofn og leysir, lausn til notkunar fyrir börn etanercept
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use Etanercept
Icelandic: Enbrel 10 mg stungulyfsstofn og leysir, lausn til notkunar fyrir börn Etanercept
English: Each pre-filled syringe of Enbrel contains 25 mg etanercept.
Icelandic: Hver áfyllt sprauta af Enbrel inniheldur 25 mg etanercept.
English: Powder for solution for injection (powder for injection).
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Step 3: Injecting the Enbrel solution
Icelandic: á Enbrel lausninni skref:
English: 1 Pre-filled syringe containing clear, colourless solvent (water for injections) 1 Needle
Icelandic: 1 áfyllt sprauta með tærum litlausum leysi (vatn fyrir stungulyf) 1 nál 1 millistykki fyrir hettuglas 2 sprittklútar
English: Do NOT rub the injection site.
Icelandic: EKKI nudda stungustaðinn.
English: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel.
Icelandic: Greint hefur verið frá tilfellum virkra berkla, þar með talið dreifberklar og berklar utan lungna hjá sjúklingum sem fengu meðferð með Enbrel.
English: In this situation, the benefit/risk balance of Enbrel therapy should be very carefully considered.
Icelandic: Meta skal vandlega ávinning umfram áhættu við Enbrel meðferð, í þessum tilfellum.
English: Enbrel 10 mg powder and solvent for solution for injection for paediatric use
Icelandic: Enbrel 10 mg stungulyfsstofn og leysir, lausn til notkunar fyrir börn
English: Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Icelandic: Svörun hjá sóragigtar sjúklingum í klínískri samanburðarrannsókn með lyfleysu % sjúklinga Lyfleysa
English: 25 mg Enbrel administered twice weekly is the recommended dose.
Icelandic: Ráðlagður skammtur er 25 mg Enbrel gefið tvisvar í viku.
English: Choosing an injection site h. Preparing the injection site and injecting the Enbrel solution i.
Icelandic: Undirbúningur og inndæling á Enbrel lausninni i.
English: Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis.
Icelandic: Enbrel miðað við samanburðarhóp, sérstaklega hjá sjúklingum með psoriasis.
English: Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 2, 4 or 12 alcohol swabs.
Icelandic: Hver askja inniheldur 2, 4, eða 12 áfyllta lyfjapenna með Enbrel og 2, 4 eða 12 sprittklúta.
English: The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly.
Icelandic: Ráðlagður skammtur af Enbrel er 25 mg tvisvar í viku eða 50 mg einu sinni í viku.
English: Cartons contain 4, 8 or 24 pre-filled pens of Enbrel with 4, 8 or 24 alcohol swabs.
Icelandic: Hver askja inniheldur 4, 8, eða 24 áfyllta lyfjapenna með Enbrel og 4, 8 eða 24 sprittklúta.
English: Enbrel 25 mg powder for solution for injection Etanercept
Icelandic: Enbrel 25 mg stungulyf, lausn í áfylltri sprautu etanercept
English: EU/1/99/126/023 4 pre-filled pens EU/1/99/126/024 8 pre-filled pens EU/1/99/126/025 24 pre-filled pens
Icelandic: EU/1/99/126/023 4 áfylltir lyfjapennar EU/1/99/126/024 8 áfylltir lyfjapennar EU/1/99/126/025 24 áfylltir lyfjapennar
English: • Wipe the site where Enbrel is to be injected with a new alcohol swab, using a circular motion.
Icelandic: Enbrel með nýjum sprittklút með hringlaga hreyfingum.
English: Enbrel 25 mg powder and solvent for solution for injection etanercept
Icelandic: Enbrel 25 mg stungulyfsstofn og leysir, lausn Etanercept
English: EU/1/99/126/019 2 pre-filled pens EU/1/99/126/020 4 pre-filled pens EU/1/99/126/021 12 pre-filled pens
Icelandic: EU/1/99/126/019 2 áfylltir lyfjapennar EU/1/99/126/020 4 áfylltir lyfjapennar EU/1/99/126/021 12 áfylltir lyfjapennar
English: Cartons contain 2, 4 or 12 pre-filled pens of Enbrel with 2, 4 or 12 alcohol swabs.
Icelandic: Hver askja inniheldur 2, 4 eða 12 áfylltar sprautur með Enbrel og 2, 4 eða 12 sprittklúta.