FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 3000 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: Innihald: 1 hettuglas með 1000 a.e. af octocog alfa, 1 hettuglas með 2 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 1000 a.e. af octocog alfa og 1 hettuglas með 2 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 250 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/004
English: Excipient related considerations
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: Check with your doctor if you are not sure.
Icelandic: - Leitið til læknisins ef þörf er á frekari upplýsingum.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 250 a.e. af octocog alfa og 1 hettuglas með 2 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/007
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: Innihald: 1 hettuglas með 1500 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 1500 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: Slight transient reddening at the administration site was observed after intraarterial application and after paravenous administration.
Icelandic: Örlítill og skamvinnur roði kom fram á íkomustað eftir inngjöf í slagæð og eftir inngjöf utan bláæðar.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: Innihald: 1 hettuglas með 1500 a.e. af octocog alfa, 1 hettuglas með 2 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: Innihald: 1 hettuglas með 1000 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 500 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 250 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 1000 a.e. af octocog alfa og 1 hettuglas með 5 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: Life-threatening haemorrhages.
Icelandic: Lífshættulegar blæðingar.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Icelandic: ADVATE 1000
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 1500 a.e. af octocog alfa og 1 hettuglas með 2 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Icelandic: 1 hettuglas með 500 a.e. af octocog alfa og 1 hettuglas með 2 ml af vatni fyrir stungulyf, forsamsett í BAXJECT III-kerfi.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000
Icelandic: ADVATE 3000
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 250 a.e. af octocog alfa, 1 hettuglas með 2 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: Dizziness
Icelandic: Ofsakláði
English: ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Icelandic: ADVATE inniheldur um það bil 50 a.e. í ml af storkuþætti VIII (rDNA) úr mönnum, octocog alfa eftir blöndun.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Icelandic: Lyfið má geyma við stofuhita (allt að 25 °C) í eitt sex mánaða tímabil.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 500 a.e. af octocog alfa, 1 hettuglas með 5 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: people).
Icelandic: Börn:
English: Haematoma
Icelandic: Ofnæmic
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Icelandic: 1 hettuglas með 500 a.e. af octocog alfa, 1 hettuglas með 2 ml af vatni fyrir stungulyf, 1 BAXJECT II-búnaður.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/03/271/001
English: Vomiting
Icelandic: Inflúensa
English: Peripheral oedema
Icelandic: B. FYLGISEÐILL
English: Factor VIII inhibition
Icelandic: Hömlun á storkuþætti VIII
English: A total of 195 subjects with severe haemophilia A (baseline factor VIII < 1%) provided PK parameters that were included in the Per-Protocol PK analysis set.
Icelandic: Lyfjahvarfabreytur sem teknar voru með í greiningum á lyfjahvörfum samkvæmt meðferð fengust hjá alls 195 sjúklingum með alvarlega dreyrasýki A (storkuþáttur VIII < 1%).
English: Abdominal pain upper
Icelandic: Octocog alfa
English: What is in this leaflet:
Icelandic: Hettuglas með leysi:
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Icelandic: Leitið til læknisins ef þörf er á frekari upplýsingum um notkun lyfsins.
English: NL-2333 CB Leiden The Netherlands
Icelandic: NL-2333 CB Leiden Holland
English: The powder should dissolve in less than 60 minutes.
Icelandic: Duftið ætti að leysast upp á innan við 60 mínútum.
English: You should not stop using SYLVANT without discussing with your doctor first.
Icelandic: Ekki hætta að nota SYLVANT án þess að ræða við lækninn fyrst.
English: • You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment.
Icelandic: Meðferðinni er haldið áfram þar til þú og læknirinn eruð sammála um að meðferðin gagnist þér ekki lengur.
English: The registry should be continued for the either 100 patients, or 5 years, whichever is greater.
Icelandic: Skráningu skal haldið áfram fyrir 100 sjúklinga eða í 5 ár, eftir því hvort er umfangsmeira.
English: Your doctor will monitor you and your liver function.
Icelandic: Læknirinn mun fylgjast með þér og lifrarstarfsemi þinni.
English: Alternatively PE bottles may be used.
Icelandic: Einnig má nota PE flöskur í staðinn.
English: 30/11/2015 (aligned with expected PSUR cycle)
Icelandic: 30/11/2015 (samhliða væntanlegum PSUR skýrslum)
English: All tumour responses were durable for > 18 weeks.
Icelandic: Öll æxlissvörun varði í > 18 vikur.
English: 206 days
Icelandic: 206 dagar
English: 134 days
Icelandic: 134 dagar
English: 70 days
Icelandic: 70 dagar
English: Characteristics, section 4.2).
Icelandic: Samantekt á eiginleikum lyfs, kafla 4.2).
English: SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Icelandic: SYLVANT verður eingöngu gefið af lækni eða hjúkrunarfræðingi á sjúkrahúsi eða læknastofu.
English: Do not remove contents until all of the powder has been completely dissolved.
Icelandic: Ekki hreyfa við lausninni fyrr en allt er fullkomlega uppleyst.
English: • cyclosporin, used during and after organ transplants
Icelandic: • cyclosporin, notað við og á eftir líffæraígræðslu
English: < 170 g/L (10.6 mmol/L)
Icelandic: < 170 g/l (10,6 mmól/l)
English: If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Icelandic: Ef þú heldur að þú hafir fengið of mikið af SYLVANT skaltu láta lækninn eða hjúkrunarfræðinginn tafarlaust vita.
English: This medicinal product is for single use only.
Icelandic: Lyfið er eingöngu einnota.
English: Dose reduction is not recommended.
Icelandic: Ekki er ráðlagt að minnka skammta.
English: It is not known what the possible side effects could be from having too much SYLVANT.
Icelandic: Ekki er þekkt hvaða aukaverkanir gætu komið af of stórum skammti af SYLVANT.
English: Discontinuing the medicinal product should be considered if there are more than 2 dose delays due to toxicities related to the treatment during the first 48 weeks.
Icelandic: Íhuga ætti að hætta notkun lyfsins ef nauðsynlegt hefur verið að seinka meira en tveimur skömmtum fyrstu 48 vikurnar vegna eiturverkana sem tengjast meðferðinni.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á umbúðunumá eftir EXP.
English: As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much.
Icelandic: Þar sem lyfið er gefið af lækni eða hjúkrunarfræðingi er ólíklegt að þú fáir of stóran skammt.
English: No dose adjustment is required (see section 5.2).
Icelandic: Ekki þarf að aðlaga skammta (sjá kafla 5.2).
English: Not reached
Icelandic: Ekki náð
English: Barnahely Ringaskiddy Co. Cork
Icelandic: Barnahely Ringaskiddy Co.
English: This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision.
Icelandic: Gjöf lyfsins á að vera í höndum sérhæfðra heilbrigðisstarfsmanna og undir viðeigandi eftirliti læknis.
English: Study 1
Icelandic: Rannsókn 1
English: The product is a freeze-dried white powder.
Icelandic: Lyfið er frostþurrkuð hvítt duft.
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun siltuximab hjá börnum 17 ára og yngri.
English: • you have liver disease or changes that show up in blood tests of the liver.
Icelandic: þú ert með lifrarsjúkdóm eða breytingar á lifrarstarfsemi sem koma fram í blóðprófum.
English: These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”).
Icelandic: Þessar sýkingar geta verið alvarlegar eins og lungnabólga eða sýklasótt (einnig kallað blóðsýking).
English: • theophylline, used to treat asthma
Icelandic: • teofyllin, notað við astma
English: It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Icelandic: Ekki er þekkt hvort SYLVANT geti haft áhrif á barnið eða á konu á meðgöngu, konu sem gefur brjóst.
English: • you have an infection at the moment - this is because SYLVANT may lower your ability to feel or fight infections, and infections may get worse.
Icelandic: þú ert með sýkingu - það er vegna þess að SYLVANT getur minnkað hæfni þína til að finna fyrir eða berjast gegn sýkingum og sýkingar geta versnað.
English: Your doctor may prescribe medicines to correct this.
Icelandic: Hugsanlega ávísar læknirinn lyfi til þess að leiðrétta þetta.
English: Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Icelandic: Greiningar á fyrsta endapunkti og aukaendapunkti hjá mismunandi undirhópum m.a. eftir aldri (< 65 ár og ≥ 65 ár); kynþætti (hvítir og ekki hvítir); svæðum (Norður-Ameríka, Evrópa, MiðAusturlönd og Afríka, og Kyrrahafsríki Asíu); steranotkun við upphaf (já og nei); fyrri meðferð (já og nei) og vefjagerðir útbreidds Castlemans sjúkdóms (plasmavefur og blandaðar tegundir) leiddu í ljós að áhrif meðferðarinnar voru hagstæð siltuximab hópnum fyrir utan undirhópinn hyaline vascular, þar sem enginn sjúklingur náði aðalendapunkti samkvæmt skilgreiningunni.
English: Your doctor may stop your treatment with SYLVANT straight away.
Icelandic: Hugsanlegt er að læknirinn stöðvi meðferð með SYLVANT samstundis.
English: Tell your doctor straight away if you get any signs of infection during treatment with SYLVANT.
Icelandic: Láttu lækninn tafarlaust vita ef þú færð einkenni sýkinga meðan á meðferð með SYLVANT stendur.
English: This leaflet was last revised in MM/YYYY Other sources of information
Icelandic: Þessi fylgiseðill var síðast uppfærður MM/ÁÁÁÁ
English: < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).
Icelandic: algengar (≥ 1/100 til < 1/10); sjaldgæfar (≥ 1/1.000 til < 1/100); mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000); koma örsjaldan fyrir (< 1/10.000).
English: Talk to your doctor, pharmacist, or nurse before you are given SYLVANT if:
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en SYLVANT er gefið ef:
English: • you have high level of fats in your blood (hypertriglyceridaemia) - this is because SYLVANT may increase these levels.
Icelandic: • þú ert með há fitugildi í blóði (þríglýseríðahækkun) - því SYLVANT getur aukið þessi gildi.
English: The results showed no significant difference in the PK of siltuximab in patients older than 65 years compared to patients age 65 years or younger.
Icelandic: Tölfræðilega marktækur munur kom ekki í ljós á lyfjahvörfum siltuximabs hjá sjúklingum eldri en 65 ára samanborið við sjúklinga 65 ára og yngri.
English: Other side effects include:
Icelandic: Einkennin eru meðal annars:
English: The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
Icelandic: Ónæmingargeta siltuximabs hefur verið metin með því að nota ensím ónæmisgreiningu EIA (antigen-bridging enzyme immunoassay) og ECLIA ónæmisgreiningu (electrochemiluminescence-based immunoassay).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Icelandic: Ef það er ekki notað strax er geymslutími og geymsluskilyrði á ábyrgð notanda.
English: Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
Icelandic: Vefjafræðilegar undirtegundir voru svipaðir hjá báðum meðferðarhópunum 33% með glærvefs (hyaline vascular) undirtegund, 23% með plasmafrumu undirtegund og 44% með blandaða undirtegund.
English: SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Icelandic: SYLVANT getur dulið einkenni bráðrar sýkingar m.a. bælt hita og bráðafasaprótein (acute phase reactant) eins og CRP (C-reactive protein).
English: The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Icelandic: Eftirfarandi þættir höfðu engin klínísk áhrif á úthreinsun siltuximabs: kyn, aldur og uppruni.
English: SYLVANT is a medicine that contains the active substance siltuximab.
Icelandic: SYLVANT er lyf sem inniheldur virka efnið siltuximab.
English: The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Icelandic: Áhrif siltuximabs á ensímvirkni CYP450 getur verið viðvarandi í nokkrar vikur eftir að meðferð hefur verið hætt.
English: Siltuximab has no or negligible influence on the ability to drive and use machines.
Icelandic: Siltuximab hefur engin eða óveruleg áhrif á hæfni til aksturs og notkunar véla.
English: Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
Icelandic: Blóðglóbulínlækkun kom í ljós hjá 4 til 11,3% sjúklinga í klínísku rannsókninni.
English: Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood
Icelandic: Algengar (geta komið fyrir hjá allt að 1 af hverjum 10 einstaklingum): • há gildi kólesteróls í blóði
English: The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction.
Icelandic: Alvarlegasta aukaverkunin sem kom fram við notkun siltuximabs var bráðaofnæmisviðbrögð.
English: SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Icelandic: Ekki er líklegt að SYLVANT hafi áhrif á hæfni til aksturs, hjólreiða og notkun tækja og véla.
English: Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter.
Icelandic: Gera á blóðrannsóknir fyrir hvern SYLVANT skammt fyrstu 12 mánuðina og þriðju hverja meðferðarlotu þaðan í frá.
English: At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Icelandic: 55% sjúklinga í siltuximab hópnum og 65% sjúklinga í lyfleysuhópnum fengið altæka meðferð við útbreiddum Castlemans sjúkdómi og 30% sjúklinga í siltuximab hópnum og 31% í lyfleysuhópnum notuðu stera.
English: The infusion should be completed within 6 hours of the addition of the reconstituted solution to the infusion bag.
Icelandic: Innrennslinu á að vera lokið innan 6 klst. frá því að blönduðu lausninni var bætt í innrennslispokann.
English: • SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
Icelandic: SYLVANT er gefið með innrennsli í bláæð (dreypi í bláæð, yfirleitt í handlegg).
English: In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Icelandic: Í forklínískum rannsóknum er þekkt að interleukin 6 (IL-6) dregur úr virkni cýtókróms P450 (CYP450).
English: Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Icelandic: Láttu lækninn tafarlaust vita ef þú færð veruleg ofnæmisviðbrögð meðan á innrennsli stendur eða á eftir.
English: SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Icelandic: SYLVANT inniheldur engin rotvarnarefni og því má ekki geyma ónotaða innrennslislausn til þess að nota síðar.
English: The effect of anti-siltuximab antibody status was not examined, as there were insufficient numbers of anti-siltuximab antibody positive patients.
Icelandic: Áhrif anti-siltuximab mótefna voru ekki rannsökuð þar sem ekki var nægur fjöldi sjúklinga anti-siltuximab mótefna jákvæður.
English: Following the single dose administration at the recommended dose regimen (11 mg/kg given once every 3 weeks), the clearance was 3.54 ± 0.44 mL/kg/day and half-life was 16.3 ± 4.2 days.
Icelandic: Eftir staka lyfjagjöf ráðlagðs skammts (11 mg/kg í eitt skipti á þriggja vikna fresti) var úthreinsun 3,54 ± 0,44 ml/kg/sólarhring og helmingunartími var 16,3 ± 4,2 sólarhringar.
English: What SYLVANT is and what it is used for What SYLVANT is
Icelandic: Upplýsingar um SYLVANT og við hverju það er notað Hvað SYLVANT er
English: The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
Icelandic: Mesta magn siltuximabs sem hefur verið gefið í klínískum rannsóknum fram til þessa er 2.190 mg í skammti (11 mg/kg).
English: In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 5.1% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
Icelandic: Í klínískum rannsóknum tengdist siltuximab innrennslistengdum viðbrögðum eða ofnæmisviðbrögðum hjá 5,1% (veruleg viðbrögð hjá 0,8%) sjúklinga sem fengu siltuximab í einlyfjameðferð.
English: Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.
Icelandic: Ekki á að gefa lifandi veiklað bóluefni meðan á meðferð með SYLVANT stendur eða 4 vikum áður en hún er hafin þar sem klínískt öryggi hefur ekki verið staðfest.
English: The following side effects may happen with this medicine.
Icelandic: Eftirfarandi aukaverkanir geta komið fram við notkun lyfsins.
English: Do not use if you see opaque or foreign particles and/or if the solution appears discoloured after reconstitution.
Icelandic: Ekki skal nota lyfið ef það inniheldur ógegnsæjar eða óþekktar agnir og/eða ef lausnin virðist mislit eftir blöndun.
English: An open-label, multicentre, non-randomised Phase 2 study assessed the safety and efficacy of extended treatment with siltuximab in 60 patients with MCD who were previously enrolled in Study 1 (41 patients) or Study 2 (19 patients).
Icelandic: Í opinni, fjölsetra óslembaðri 2. stigs rannsókn var öryggi og verkun metið í framlengdri rannsókn með siltuximabi hjá 60 sjúklingum með útbreiddan Castlemans sjúkdóm sem höfðu áður verið skráðir í rannsókn 1 (41 sjúklingur) eða rannsókn 2 (19 sjúklingar).
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Icelandic: Verulegt ofnæmi fyrir virka efninu eða einhverju hjálparefnanna sem talin eru upp í kafla 6.1.
English: However, there is also evidence to suggest that IL-6 inhibition may suppress immune responses, immune surveillance and lower defense against established tumours.
Icelandic: Þó eru einnig vísbendingar þess efnis að IL-6 hemlar geti bælt ónæmissvörun, ónæmiseftirlit og dregið úr vörnum gegn staðfestum æxlum.