FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in Table 6 and described below.
Icelandic: Lykilniðurstöður hjá hópnum sem fékk 50 mg skammt í vikum 14 og 24 eru sýndar í töflu 6 og er lýst hér að neðan.
English: Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including golimumab.
Icelandic: Greint hefur verið frá versnun hjartabilunar og nýtilkominni hjartabilun í tengslum við TNF-hemla, þ.m.t. golimumab.
English: Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism and goitre)
Icelandic: Sjaldgæfar: Skjaldkirtilstruflun (t.d. vanvirkni skjaldkirtils eða ofvirkni skjaldkirtils og skjaldkirtilsstækkun)
English: Ankylosing spondylitis (AS)
Icelandic: CHAQ Sökk (ESR) (mm/h)
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Icelandic: Innan hvers líffæraflokks eru aukaverkanirnar flokkaðar eftir tíðni á eftirfarandi hátt:
English: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
Icelandic: • í meðallagi alvarlegri/alvarlegri virkri iktsýki hjá fullorðnum, þegar svörun við sjúkdómstemprandi gigtarlyfjum, að metótrexati meðtöldu, hefur reynst ófullnægjandi.
English: Simponi 100 mg solution for injection in pre-filled syringe.
Icelandic: Simponi 100 mg stungulyf, lausn í áfylltri sprautu.
English: Injecting the medicine
Icelandic: UM AÐ LYFIÐ
English: • Failure of the bone marrow to produce blood cells
Icelandic: Beinmergur framleiðir ekki nægjanlegt magn blóðfrumna
English: • Melanoma (a type of skin cancer)
Icelandic: Sortuæxli (tegund húðkrabbameins)
English: Simponi is for subcutaneous use.
Icelandic: Simponi er til notkunar undir húð.
English: 1st administration: _______________________
Icelandic: Fyrsta lyfjagjöf:__________________
English: Subject/parent global assessment of overall well-being (VAS 0-10 cm) Number of active joints Number of joints with limited range of motion Physical function by CHAQ ESR (mm/h)
Icelandic: Heildarmat þátttakanda/foreldris á heilsufari (VAS verkjaskali 0-10 cm) Fjöldi virkra liðamóta
English: • Certain vaccinations may cause infections.
Icelandic: Ákveðnar bólusetningar geta valdið sýkingum.
English: The efficacy of Simponi was demonstrated in three multi-centre, randomised, double-blind, placebo-controlled studies in over 1500 patients ≥ 18 years of age with moderately to severely active RA diagnosed according to American College of Rheumatology (ACR) criteria for at least 3 months prior to screening.
Icelandic: ≥ 18 ára með í meðallagi alvarlega til alvarlega iktsýki samkvæmt viðmiðun American College of Rheumatology (ACR) í að minnsta kosti 3 mánuði fyrir skimun.
English: Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman.
Icelandic: Greinst hafa mótefni í sermi í allt að 6 mánuði hjá ungbörnum kvenna sem hafa fengið meðferð með TNF- hamlandi einstofna mótefni á meðgöngu.
English: In the controlled period of RA and PsA pivotal trials, mild ALT elevations (> 1 and < 3 x upper limit of normal (ULN)) occurred in similar proportions of golimumab and control patients in the RA and PsA studies (22.1% to 27.4% of patients); in the AS and nr-Axial SpA studies, more golimumab-treated patients (26.9%) than control patients (10.6%) had mild ALT elevations.
Icelandic: Á samanburðartímabilum lykilrannsókna á iktsýki og sóraliðagigt kom fram væg hækkun á ALT gildum (> 1 og < 3 föld eðlileg efri mörk) í svipuðum hlutföllum hjá sjúklingum sem fengu golimumab og sjúklingum sem fengu lyfleysu (22,1% til 27,4%).
English: 50 mg) subcutaneously every 4 weeks, had median steady-state trough golimumab concentrations which were similar across different age groups, and which were also similar to or slightly higher than those seen in adult RA patients who received 50 mg golimumab every 4 weeks.
Icelandic: 30 mg/m2 (hámark 50 mg) undir húð fjórðu hverja viku, var miðgildi jafnvægis í lágildi fyrir þéttni golimumabs svipað innan mismunandi aldurshópa og var svipað til lítillega hærra en hliðstæð gildi sem komu fram hjá fullorðnum sjúklingum með liðagigt sem fengu
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Icelandic: Geymið áfyllta sprautuna í ytri umbúðum til varnar gegn ljósi
English: What Simponi contains The active substance is golimumab.
Icelandic: Simponi inniheldur virka efnið golimumab.
English: In the controlled and uncontrolled periods of RA, PsA and AS pivotal trials, with a median follow-up of 5 years, the incidence of ALT elevations ≥ 5 x ULN was similar in both golimumab-treated and control patients.
Icelandic: Á tímabilum með og án samanburðar í lykilrannsóknunum á iktsýki, sóraliðagigt og hryggikt, þar sem miðgildi eftirfylgni var 5 ár, var tíðni hækkana ALT ≥ 5 föld eðlileg efri mörk svipuð hjá sjúklingum sem fengu golimumab og samanburðarhópi sjúklinga.
English: The needle cover should not be removed until you are ready to inject the medicine.
Icelandic: Ekki fjarlægja nálarhettuna fyrr en rétt áður en lyfið er gefið.
English: Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Icelandic: Meðal sjúklinga sem héldu áfram í rannsókninni og fengu meðferð með Simponi hélst bati varðandi HAQ DI svipaður frá viku 104 út viku 256.
English: General disorders and administration site conditions Common: Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort Rare: Impaired healing Injury, poisoning and procedural complications
Icelandic: Hiti, þróttleysi, viðbrögð á inndælingarstað (t.d. hörundsroði, ofsakláði, herslismyndun, verkur, mar, kláði, erting og náladofi), óþægindi fyrir brjósti Mjög sjaldgæfar:
English: Improvements were observed at the first assessment (week 4) after the initial Simponi administration.
Icelandic: Bati kom fram við fyrsta mat (vika 4) eftir upphafsgjöf Simponi.
English: Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Icelandic: 52 fyrir 126 sjúklinga, engin breyting var frá upphafsgildi hjá 77% þeirra.
English: What Simponi contains
Icelandic: Simponi inniheldur
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.
Icelandic: Í GO-FORWARD var klínískt mikilvægur og tölfræðilega marktækur bati á þáttum heilsutengdra lífsgæða með því að nota mælingu á líkamlega þættinum í SF-36 hjá sjúklingum sem fengu
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, DAS28 responses were maintained through week 104.
Icelandic: á Simponi meðferðinni sem þeir fengu samkvæmt slembiröðun í upphafi rannsóknarinnar hélst DAS28 svörun út viku 104.
English: Patients should be tested for HBV infection before initiating treatment with golimumab.
Icelandic: B sýkingu áður en meðferð með golimumabi er hafin.
English: For additional assistance refer to the Package Leaflet for your local representative contact information.
Icelandic: Varðandi frekari upplýsingar sjá upplýsingar um umboðsmann á hverjum stað í fylgiseðlinum.
English: Similar ACR 20 responses at week 14 were observed in patients with polyarticular arthritis with no rheumatoid nodules and asymmetric peripheral arthritis PsA subtypes.
Icelandic: Svipuð ACR 20 svörun kom fram hjá sjúklingum með undirtegundir sóraliðagigtar; fjölliðagigt án gigtarhnúta og ósamhverfa liðagigt í útlimum í viku
English: • In patients weighing less than 80 kg, 50 mg (the 50 mg pre-filled pen or pre-filled syringe must be used to administer this dose) 4 weeks after your last treatment, then every 4 weeks thereafter.
Icelandic: Hjá sjúklingum sem eru léttari en 80 kg, 50 mg (50 mg áfyllti penninn eða áfyllta sprautan notuð til að gefa skammtinn) 4 vikum eftir síðustu meðferð, síðan á 4 vikna fresti eftir það.
English: Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma* Blood and lymphatic system disorders
Icelandic: Eitilæxli, hvítblæði, sortuæxli, bjálkakrabbamein (Merkel cell carcinoma)
English: Simponi should not be used if the solution is discoloured, cloudy or containing visible foreign particles.
Icelandic: Ekki á að nota Simponi ef lausnin hefur breytt um lit, er skýjuð eða ef framandi agnir eru í henni.
English: In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Icelandic: Á samanburðartímabilum lykilrannsókna og út eftirfylgni í u.þ.b. 4 ár var tíðni illkynja sjúkdóma annarra en eitilæxla (að undanskildu húðkrabbameini sem ekki er sortuæxli) svipuð hjá þeim sem fengu golimumab og samanburðarhópum.
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased Uncommon: Cholelithiasis, hepatic disorders Skin and subcutaneous tissue disorders
Icelandic: Hækkun alanínamínótransferasa, hækkun aspartatamínótransferasa Sjaldgæfar:
English: The incidence per 100 subject-years of all serious infections was 4.1; 95% CI: 3.6, 4.5, in patients receiving golimumab 100 mg and 2.5; 95% CI: 2.0, 3.1, in patients receiving golimumab 50 mg.
Icelandic: 3,6; 4,5 hjá sjúklingum sem fengu golimumab 100 mg og 2,5; 95% öryggisbil:
English: Keep the pre-filled syringe in the outer carton in order to protect from light Can be stored at room temperature (up to 25°C) for a single period up to 30 days, but not exceeding the original expiry date
Icelandic: Geymið áfylltu sprautuna í ytri umbúðum til varnar gegn ljósi Má geyma við stofuhita (að hámarki 25°C) í eitt tímabil sem varir allt að 30 daga en ekki umfram upprunalega fyrningardagsetningu.
English: One 0.5 mL pre-filled syringe contains 50 mg of golimumab.
Icelandic: Ein 0,5 ml áfyllt sprauta inniheldur 50 mg af golimumabi.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
Icelandic: Simponi 45 mg/0,45 ml stungulyf, lausn í áfylltum lyfjapenna.
English: GO-BEFORE Active RA, MTX Naïve
Icelandic: GO-BEFORE Virk iktsýki, ekki fengið metótrexat áður
English: Comprehensive instructions for the preparation and administration of Simponi in a pre-filled pen are included in the pack.
Icelandic: Almennar leiðbeiningar um undirbúning og gjöf Simponi í áfylltum lyfjapenna eru í fylgiseðlinum.
English: In controlled and uncontrolled periods of the UC pivotal trials with a median follow-up of approximately 2 years, the proportion of patients with mild ALT elevations was 24.7% in patients receiving golimumab during the maintenance portion of the UC study.
Icelandic: 2 ár, var hlutfall sjúklinga með væga hækkun ALT gilda 24,7% hjá sjúklingum sem fengu golimumab á tímabili viðhaldsmeðferðar í rannsókninni á sáraristilbólgu.
English: Patients were randomised to receive placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX or Simponi 100 mg + placebo.
Icelandic: Sjúklingum var slembiraðað og fengu lyfleysu og metótrexat, Simponi 50 mg og metótrexat, Simponi 100 mg og metótrexat eða Simponi 100 mg og lyfleysu.
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1.
Icelandic: 1 má sjá lista yfir aukaverkanir sem fram komu í klínískum rannsóknum með golimumabi og sem greint var frá eftir markaðssetningu á heimsvísu.
English: • Wait 30 minutes to allow the product to reach room temperature
Icelandic: Bíðið í 30 mín og leyfið lyfinu að ná stofuhita
English: • Leukaemia
Icelandic: A. ÁLETRANIR
English: Signs and symptoms Key results for the 50 mg dose at weeks 14 and 24 are shown in table 4 and described below.
Icelandic: Lykilniðurstöður hjá hópnum sem fékk 50 mg skammt í vikum 14 og 24 eru sýndar í töflu 4 og er lýst hér að neðan.
English: What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled pen.
Icelandic: Simponi er stungulyf, lausn í einnota áfylltum penna.
English: Statistically significant improvements in signs and symptoms of severe active nr-Axial SpA were demonstrated in patients treated with Simponi 50 mg compared to placebo at week 16 (Table 6).
Icelandic: Tölfræðilega marktækur bati í merkjum og einkennum alvarlegrar virkrar áslægrar hryggiktar sem ekki greinist með myndgreiningu kom fram hjá sjúklingum sem fengu meðferð með Simponi 50 mg samanborið við lyfleysu eftir 16 vikur (tafla 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Lýsing á útliti Simponi og pakkningastærðir
English: • signs of immune system disorders called: lupus (rare).
Icelandic: einkenni ónæmissjúkdóms sem kallast: rauðir úlfar (mjög sjaldgæft).
English: Allow the pen to sit at room temperature outside the box for 30 minutes before use.
Icelandic: Takið pennann úr öskjunni og látið vera í stofuhita í 30 mínútur fyrir notkun.
English: Rare: Bladder disorders, renal disorders Reproductive system and breast disorders
Icelandic: Blöðrukvillar, nýrnakvillar Æxlunarfæri og brjóst
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement in HAQ DI was maintained through week 104.
Icelandic: á Simponi meðferðinni sem þeir fengu samkvæmt slembiröðun í upphafi rannsóknarinnar hélst bati varðandi HAQ DI út viku 104.
English: • Talk to your doctor if you are going to have any operations or dental procedures.
Icelandic: Hafðu samband við lækninn ef einhvers konar skurðaðgerð eða tannaðgerð er fyrirhuguð.
English: Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Icelandic: Fullnægjandi upplýsingar um meðferð með veirulyfjum til að hindra endurvirkjun lifrarbólgu
English: Malignancies other than lymphoma
Icelandic: Illkynja sjúkdómar aðrir en eitilæxli
English: • Patients with severe rheumatoid arthritis and other inflammatory diseases, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Icelandic: Sjúklingar með alvarlega iktsýki eða aðra langvinna bólgusjúkdóma geta verið í meiri hættu á að fá eitilæxli.
English: EU/1/09/546/007 1 pre-filled syringe EU/1/09/546/008 3 pre-filled syringes
Icelandic: EU/1/09/546/007 1 áfyllt sprauta EU/1/09/546/008 3 áfylltar sprautur
English: SINGLE-USE
Icelandic: Sjálfsnæmismótefni
English: Tap air bubbles to top Hold the pre-filled pen upright with the blue cap pointing up.
Icelandic: Sláðu loftbólur að toppnum Haltu áfyllta lyfjapennanum uppréttum þannig að bláa hettan vísi upp.
English: Lymphoma and leukaemia
Icelandic: Dofi eða náladofi
English: You may or may not feel a needle prick at this time.
Icelandic: Ekki er víst að þú finnir fyrir nálinni.
English: A part of the pre-filled syringe, the needle cover, contains latex.
Icelandic: Nálarhlífin á áfylltu sprautunni inniheldur latex.
English: A starting dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Icelandic: Upphafsskammtur 200 mg (innihald 4 áfylltra lyfjapenna) eftir það 100 mg (innihald 2 áfylltra lyfjapenna) 2 vikum síðar.
English: Symptoms of infection include fever, cough, shortness of breath, flu-like symptoms, diarrhoea, wounds, dental problems or a burning feeling when urinating.
Icelandic: Einkenni geta m.a. verið hiti, hósti, mæði, flensulík einkenni, niðurgangur, sár, tannvandamál eða sviði við þvaglát.
English: b < 1.3 BASDAI 50 Inhibition of inflammation in sacroiliac (SI) joints as measured by MRI Placebo Simponi 50 mg Placebo Simponi 50 mg
Icelandic: Hömlun bólgu í spjaldlið (SI), mælt með segulómun Lyfleysa Simponi 50 mg Lyfleysa Simponi 50 mg n
English: In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
Icelandic: stigs samanburðarrannsóknum á iktsýki, sóraliðagigt, hryggikt, áslægri hryggikt sem ekki greinist í myndgreiningu, alvarlegum þrálátum astma og II./III. stigs rannsóknum á sáraristilbólgu fékk enginn sjúklingur bráðaofnæmi eftir meðferð með golimumabi.
English: In the controlled period of RA, PsA, AS, and nr-Axial SpA trials, serious infections were observed in 1.2% of golimumab-treated patients and 1.2% of control-treated patients.
Icelandic: Á samanburðartímabili rannsókna hjá sjúklingum með iktsýki, sóraliðagigt, hryggikt og áslæga hryggikt sem ekki greinist með myndgreiningu sáust alvarlegar sýkingar hjá 1,2% sjúklinga sem fengu golimumab og hjá 1,2% sjúklinga í samanburðarhóp.
English: 0.45 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Icelandic: 0,45 ml lausn í áfylltri sprautu (gler af tegund 1) með áfastri nál (ryðfrítt stál) og nálarhlíf (gúmmí sem inniheldur latex) í áfylltum lyfjapenna.
English: Simponi 50 mg solution for injection in pre-filled syringe.
Icelandic: Simponi 50 mg stungulyf, lausn í áfylltri sprautu.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab.
Icelandic: Fylgjast verður náið með sýkingum hjá sjúklingum m.a. berklum áður en meðferð með golimumabi hefst, meðan á henni stendur og eftir að henni lýkur.
English: Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Icelandic: Sjúklingar fengu að halda áfram að taka sjúkdómstemprandi gigtarlyfin metótrexat, súlfasalazín og/eða hýdroxýklórókín meðan á meðferð stóð.
English: Do not press the plunger while inserting the needle.
Icelandic: Ekki þrýsta á stimpilinn á meðan nálinni er stungið inn.
English: Tell your doctor straight away if symptoms of TB appear during or after your treatment.
Icelandic: Berklar Segðu lækninum samstundis frá því ef þú finnur fyrir einkennum berkla meðan á meðferð stendur eða eftir meðferð.
English: • The recommended dose is 50 mg given once a month, on the same date each month.
Icelandic: Ráðlagður skammtur er 50 mg, gefinn einu sinni í mánuði á sama degi hvers mánaðar.
English: Dose selection notch
Icelandic: Veljið stungustað
English: Solution for injection in pre-filled pen (SmartJect) 1 pre-filled pen
Icelandic: Stungulyf, lausn í áfylltum lyfjapenna (SmartJect) 1 áfylltur lyfjapenni
English: Simponi 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Icelandic: Simponi 100 mg stungulyf, lausn í áfylltri sprautu 1 ml lausn í áfylltri sprautu (gler af tegund 1) með áfastri nál (ryðfrítt stál) og nálarhlíf (gúmmí sem inniheldur latex).
English: Solution for injection in pre-filled syringe (injection)
Icelandic: Stungulyf, lausn í áfylltri sprautu (stungulyf)
English: Adult psoriatic arthritis
Icelandic: stigs klínískum rannsóknum
English: Orange Priming Band
Icelandic: Appelsínugul nálarhlíf
English: • For patients weighing at least 40 kg, the recommended dose is 50 mg given once a month, on the same date each month.
Icelandic: 40 kg, ráðlagður skammtur er 50 mg gefið einu sinni í mánuði, á sama mánaðardegi hvern mánuð.
English: Paediatric population
Icelandic: Hlutfall sjúklinga
English: In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
Icelandic: ≥ 5 föld eðlileg efri mörk í svipuðum hlutföllum hjá sjúklingum sem fengu meðferð með golimumabi og sjúklingum sem fengu lyfleysu (0,3% til 1,0%, talið í sömu röð).
English: • Thyroid disorders
Icelandic: Meltingartruflanir
English: • New and worsening congestive heart failure has been reported with TNF blockers, including
Icelandic: Greint hefur verið frá nýtilkominni og versnandi hjartabilun við notkun TNF-hemla, þ.m.t.
English: There was a trend toward higher apparent clearance of golimumab with increasing weight (see section 4.2).
Icelandic: Áhrif þyngdar á lyfjahvörf Tilhneiging var til aukinnar úthreinsunar golimumabs með aukinni líkamsþyngd (sjá kafla 4.2).
English: For children with body weight of at least 40 kg, a fixed dose 50 mg pre-filled pen or pre-filled syringe is available.
Icelandic: 40 kg er hægt að fá áfylltan lyfjapenna eða áfyllta sprautu með 50 mg föstum skammti.
English: • Cancers, including skin cancer and non-cancerous growths or lumps, including skin moles
Icelandic: Krabbamein, m.a. húðkrabbamein og góðkynja vöxtur eða hnútar, þ.m.t. blettir
English: Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator).
Icelandic: dag/mánuð/ár (allt að 30 dögum frá dagsetningu þegar lyfið var tekið úr kæli).
English: Simponi 50 mg injection golimumab SC
Icelandic: Simponi 50 mg stungulyf, lausn golimumab s.c.
English: In controlled and uncontrolled portions of the trials with a median follow-up of approximately 4 years, the incidence per 100 subject-years of infections was 81.1 events; 95% CI: 79.5, 82.8 for golimumab treated patients.
Icelandic: Í þeim hlutum rannsóknanna sem voru með samanburði og þeim sem ekki voru með samanburði, þar sem miðgildi eftirfylgni var u.þ.b. 4 ár, var tíðni sýkinga á hver 100 sjúklingaár 81,1 tilvik; 95% öryggisbil:
English: Simponi 45 mg/0.45 mL solution for injection
Icelandic: Simponi 45 mg/0,45 ml stungulyf, lausn
English: Malignancies
Icelandic: Taugasjúkdómar
English: Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Icelandic: Sjúklingum skal sagt hverjir hugsanlegir áhættuþættir sýkinga eru og þeim skal ráðlagt að forðast þá eins og við á.
English: Patients were randomly assigned to placebo or Simponi 50 mg administered subcutaneously every 4 weeks.
Icelandic: Sjúklingum var slembiraðað til að fá lyfleysu eða Simponi 50 mg, gefið undir húð á fjögurra vikna fresti.
English: • 1 Adhesive bandage
Icelandic: 1 áfylltur lyfjapenni
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Icelandic: Sérfræðingur með reynslu í greiningu og meðferð á iktsýki, fjölliða sjálfvakinni barnaliðbólgu, sóraliðagigt, hryggikt, áslægri hryggikt sem ekki greinist með myndgreiningu eða sáraristilbólgu skal hefja og annast meðferð.
English: Through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar to the general population.
Icelandic: Út eftirfylgni í u.þ.b. 4 ár var tíðni illkynja sjúkdóma annarra en eitilæxla (að undanskildu húðkrabbameini sem ekki er sortuæxli) svipuð og almennt gengur og gerist meðal fólks.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen golimumab
Icelandic: Simponi 45 mg/0,45 ml stungulyf, lausn í áfylltum lyfjapenna golimumab
English: Invasive fungal infections
Icelandic: Endurvirkjun lifrarbólgu
English: Your pre-filled pen at-a-glance
Icelandic: T-frumu eitilæxli í lifur og milta*