FrancophonIA/ELRC3.0 huggingface dataset:
English: Levofloxacina Mylan Levofloxacin 500mg Tablet
Icelandic: Levofloxacina Mylan Levóflóxacín 500mg tafla
English: Norfloxacine Sandoz Norfloxacin 400mg Tablet
Icelandic: Norfloxacin Sandoz Nórflóxacín 400mg tafla
English: Levofloxacin Accord Levofloxacin 500mg/100 Ml
Icelandic: Accord Healthcare Limited Levofloxacin Accord Levóflóxacín 500mg/100ml
English: Levofloxacin B. Braun Levofloxacin 5mg/Ml
Icelandic: Levofloxacin B. Braun Levóflóxacín 5mg/ml
English: Ciprofloxacin Hydrochloride 334.8mg Tablet
Icelandic: Cípróflóxacínhýdróklóríð 334,8mg tafla
English: Remedica Ltd
Icelandic: Pharma Ltd
English: Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Icelandic: Ciprofloxacina Sandoz Cípróflóxacín 750mg tafla
English: Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Icelandic: Accord Healthcare Limited Levofloxacina Accord Levóflóxacín hemihýdrat 256,23mg tafla
English: Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 100mg Tablet
Icelandic: Ciprofloxacin Teva Uk Cípróflóxacínhýdróklóríð 100mg tafla
English: Ciprofloxacină Arena Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacină Arena Cípróflóxacín 500mg tafla
English: Levofloxacin Actavis Levofloxacin 250mg Tablet
Icelandic: Levofloxacin Actavis Levóflóxacín hemihýdrat 250mg tafla
English: Heumann Pharma Gmbh & Co. Generica Kg
Icelandic: Þýskaland Heumann Pharma Gmbh & Co.
English: Moxifloxacina Mylan Moxifloxacin 400mg Tablet
Icelandic: Moxifloxacina Mylan Moxíflóxacín 400mg tafla
English: Levofloxacine B. Braun Levofloxacin 5mg/Ml
Icelandic: Levofloxacine B. Braun Levóflóxacín 5mg/ml
English: Ciprofloxacine Mylan Ciprofloxacin 250mg Tablet
Icelandic: Ciprofloxacin Mylan Cípróflóxacín 250mg tafla
English: Levofloksacin B. Braun Levofloxacin 500mg/100 Ml
Icelandic: Levofloksacin B. Braun Levóflóxacín 500mg/100ml
English: Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacine Mylan Cípróflóxacín 500mg tafla
English: Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Icelandic: Ciprofloxacina Mylan Cípróflóxacín 250mg tafla
English: Ciprofloxacina Actavis Ciprofloxacin 750mg Tablet
Icelandic: Ciprofloxacina Actavis Cípróflóxacín 750mg tafla
English: Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Icelandic: Ciprofloxacine Sandoz Cípróflóxacín 750mg tafla
English: Ciprofloxacino Tevagen Ciprofloxacin 250mg Tablet
Icelandic: Ciprofloxacino Tevagen Cípróflóxacín 250mg tafla
English: Moxifloxacino Sandoz Moxifloxacin 400mg Tablet
Icelandic: Moxifloxacino Sandoz Moxíflóxacín 400mg tafla
English: Levofloxacin Hemihydrate 256.23mg Vial
Icelandic: Levóflóxacín hemihýdrat 256,23mg hettuglas
English: Hec Pharm Gmbh
Icelandic: Þýskaland HEC Pharm GmbH
English: Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Icelandic: Moxifloxacina Sandoz Moxíflóxacín 400mg tafla
English: Ciprofloxacina Sandoz Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacina Sandoz Cípróflóxacín 500mg tafla
English: Ciprofloxacin Alvogen Ciprofloxacin Lactate 2mg/Ml
Icelandic: Ciprofloxacin Alvogen Cípróflóxacín laktat 2mg/ml
English: Braun” Levofloxacin 5mg/Ml
Icelandic: Infomed Levóflóxacín 5mg/ml
English: Moxifloxacin Hydrochloride 436.8mg Tablet
Icelandic: Moxifloxacina Cinfa Moxíflóxacínhýdróklóríð 436,8mg tafla
English: Ciprofloxacin Lactate 254.4mg Vial
Icelandic: Cípróflóxacín laktat 254,4mg hettuglas
English: Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacino Sandoz Cípróflóxacín 500mg tafla
English: Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacin Mylan Cípróflóxacín 500mg tafla
English: Levofloxacin Hetero Levofloxacin Hemihydrate 512.47mg Tablet
Icelandic: Levofloxacino Cipla Levóflóxacín hemihýdrat 512,47mg tafla
English: Ciprofloxacine Sandoz Ciprofloxacin Hydrochloride 250mg Tablet
Icelandic: Ciprofloxacine Sandoz Cípróflóxacín 250mg tafla
English: Levofloxacino Sandoz Levofloxacin 500mg Tablet
Icelandic: Levofloxacino Sandoz Levóflóxacín 500mg tafla
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Icelandic: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Cípróflóxacínhýdróklóríð 873mg tafla
English: Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Icelandic: Moxifloxacin Mylan Moxíflóxacín 400mg tafla
English: Levofloxacina Zentiva Levofloxacin 250mg Tablet
Icelandic: Levofloxacina Zentiva Levóflóxacín 250mg tafla
English: Netherlands Fresenius Kabi Nederland B.V.
Icelandic: Fresenius Kabi Nederland B.V. Ciprofloxacine Kabi
English: Mip Pharma Gmbh
Icelandic: Þýskaland Mip Pharma Gmbh
English: Levofloxacina B. Braun Levofloxacin 500mg/100 Ml
Icelandic: Levofloxacina B. Braun Levóflóxacín 500mg/100ml
English: Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Icelandic: Arcana Arzneimittel Gmbh Levofloxacin Arcana Levóflóxacín 250mg/50ml
English: 256.23mg Tablet
Icelandic: Pípemíðsýruþríhýdrat 235,63mg hylki
English: Moxifloxacino Gadur Vegal Farmacéutica, S.L.
Icelandic: Gadur Vegal Farmacéutica, S.L.
English: Levofloxacine Sandoz Levofloxacin 250mg Tablet
Icelandic: Levofloxacin Sandoz Levóflóxacín 250mg tafla
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Icelandic: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Cípróflóxacínhýdróklóríð 582mg tafla
English: Norfloxacino Normon Norfloxacin 400mg Tablet
Icelandic: Normon Nórflóxacín 400mg tafla
English: Levofloxacino B. Braun Levofloxacin 500mg/100 Ml
Icelandic: Levofloxacino B. Braun Levóflóxacín 500mg/100ml
English: Levofloxacin Lyomark Levofloxacin 250mg/50 Ml
Icelandic: Lyomark Levóflóxacín 250mg/50ml
English: Norfloxacino Qualigen Norfloxacin 400mg Tablet
Icelandic: Qualigen Nórflóxacín 400mg tafla
English: Levofloxacin B. Braun Levofloxacin 500mg/100 Ml
Icelandic: Levofloxacin B. Braun Levóflóxacín 500mg/100ml
English: Levofloxacina Zentiva Levofloxacin 500mg Tablet
Icelandic: Levofloxacina Zentiva Levóflóxacín 500mg tafla
English: Ciprofloxacine Mylan Ciprofloxacin Hydrochloride 250mg Tablet
Icelandic: Ciprofloxacine Mylan Cípróflóxacín 250mg tafla
English: Ciprofloxacin Lactate 508.8mg Vial
Icelandic: Cípróflóxacín laktat 508,8mg hettuglas
English: Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacine Sandoz Cípróflóxacín 500mg tafla
English: Moxifloxacine Mylan Moxifloxacin Hydrochloride 400mg Tablet
Icelandic: Moxifloxacine Mylan Moxíflóxacín 400mg tafla
English: Ofloxacin Generics Uk Ofloxacin 200mg Tablet
Icelandic: Uk Oflóxacín 200mg tafla
English: Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Icelandic: Ciprofloxacin Sandoz Cípróflóxacín 750mg tafla
English: Ranbaxy Pharmacie Generiques Levofloxacine Ranbaxy Levofloxacin 500mg Tablet
Icelandic: Levofloxacine Ranbaxy Levóflóxacín 500mg tafla
English: Levofloxacina Sandoz Levofloxacin 250mg Tablet
Icelandic: Levofloxacina Sandoz Levóflóxacín 250mg tafla
English: Levofloxacine Sandoz Levofloxacin 500mg Tablet
Icelandic: Levofloxacin Sandoz Levóflóxacín 500mg tafla
English: Levofloxacino Normon Levofloxacin Hemihydrate 513mg Tablet
Icelandic: Levofloxacino Normon Levóflóxacín hemihýdrat 513mg tafla
English: Ciprofloxacina Actavis Ciprofloxacin 250mg Tablet
Icelandic: Ciprofloxacina Sandoz Cípróflóxacín 250mg tafla
English: Ciprofloxacin Milpharm Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacin Milpharm Cípróflóxacín 500mg tafla
English: Ciprofloxacine Arrow Ciprofloxacin 500mg Tablet
Icelandic: Ciprofloxacine Arrow Cípróflóxacín 500mg tafla
English: Levofloxacin Actavis Levofloxacin Hemihydrate 250mg Tablet
Icelandic: Ciprofloxacin Actavis Cípróflóxacínhýdróklóríð mónóhýdrat 250mg tafla
English: Ciprofloxacin Hydrochloride 582.37mg Tablet
Icelandic: Cípróflóxacínhýdróklóríð 582,37mg tafla
English: Ljubljana
Icelandic: Jelfa
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Icelandic: Levofloxacina Arena Levóflóxacín hemihýdrat 256,23mg tafla
English: 250mg Tablet
Icelandic: Nalidixínsýra 500mg hylki
English: Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Icelandic: Ciprofloxacina Germed Cípróflóxacínhýdróklóríð mónóhýdrat 873mg tafla
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Icelandic: Levofloxacine Pch Levóflóxacín hemihýdrat 512,46mg tafla
English: Ofloxacin Hydrochloride 220mg/100 Ml
Icelandic: Oflóxacínhýdróklóríð 220mg/100ml
English: Levofloxacin Accord Levofloxacin 250mg/50 Ml
Icelandic: Accord Healthcare Limited Levofloxacin Accord Levóflóxacín 250mg/50ml
English: Moxifloxacin Hydrochloride 436.37mg Tablet
Icelandic: Moxifloxacin Actavis Moxíflóxacínhýdróklóríð 436,37mg tafla
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Icelandic: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Cípróflóxacínhýdróklóríð 291mg tafla
English: Moxifloxacin Hydrochloride 400mg Tablet
Icelandic: Qualigen Moxíflóxacín 400mg tafla
English: Levofloxacina Sandoz Levofloxacin 500mg Tablet
Icelandic: Levofloxacina Sandoz Levóflóxacín 500mg tafla
English: Tel.: +44(0)1256 894 959
Icelandic: Sími: +44(0)1256 894 959
English: Annually within the annual reassessment
Icelandic: Á hverju ári með árlega endurmatinu.
English: <There are also links to other websites about rare diseases and treatments.
Icelandic: Þar eru líka tenglar á aðra vefi um sjaldgæfa sjúkdóma og lyf við þeim.
English: Before starting reconstitution you will need the following:
Icelandic: Áður en þú byrjar blöndun þarftu eftirfarandi:
English: Of these 11 subjects, eight had eventual successful treatment (73%).
Icelandic: Af þessum 11 þátttakendum, skilaði meðferðin árangri hjá átta (73%).
English: OBIZUR is indicated in adults.
Icelandic: OBIZUR er ætlað fullorðnum.
English: 500 U
Icelandic: 500 e.
English: The maximum blood FVIII activity must not exceed 200%.
Icelandic: Hámarksvirkni storkuþáttar VIII í blóði má ekki fara yfir 200%.
English: Remove the plastic package (Figure E).
Icelandic: Fjarlægið plastpakkninguna (Mynd E).
English: ATC code: B02BD14
Icelandic: B02BD14
English: You should contact your doctor if you missed a dose and do not know how to compensate for this.
Icelandic: Hafðu samband við lækninn ef þú gleymdir skammti og veist ekki hvernig á að bæta hann upp.
English: Your doctor will also check if the bleeding is adequately controlled.
Icelandic: Læknirinn mun einnig athuga hvort nægileg stjórn hafi náðst á blæðingunni.
English: A total of 24/28 (86%) had successful control (resolution) of the initial bleeding episode.
Icelandic: Alls náðu 24/28 (86%) árangursríkri stjórn (lausn) á upphafsblæðingarkastinu.
English: Extensive cutaneous purpura do not necessarily require treatment.
Icelandic: Útbreiddur purpuri í húð krefst ekki endilega meðferðar.
English: A positive response was observed in 95% (19/20) of subjects evaluated at 8 hours and 100% (18/18) at 16 hours.
Icelandic: Jákvæð svörun kom fram hjá 95% (19/20) einstaklinga sem metnir voru eftir 8 klst. og 100% (18/18) eftir 16 klst.
English: You must contact your doctor immediately if you have any of the following early symptoms:
Icelandic: Þú verður að hafa strax samband við lækninn ef þú finnur fyrir einhverjum eftirtöldum byrjunareinkennum ofnæmisviðbragða:
English: It requires clinical supervision of the bleeding status of the patient.
Icelandic: Það krefst eftirlits með blæðingarástandi sjúklingsins.
English: Your doctor will calculate your dose of OBIZUR (in units or U) depending on your condition and body weight.
Icelandic: Læknirinn mun reikna út skammtinn af OBIZUR (í einingum eða e.) eftir ástandi þínu og líkamsþyngd.
English: Efficacy and safety data in patients with acquired haemophilia are limited (see section 5.1).
Icelandic: Upplýsingar um verkun og öryggi hjá sjúklingum með áunna dreyrasýki eru takmarkaðar (sjá kafla 5.1).
English: Subjects were in a non-bleeding state.
Icelandic: Þátttakendurnir voru ekki blæðandi.
English: If severe and sudden allergic reactions occur, the injection must be stopped immediately.
Icelandic: Ef skyndileg, alvarleg ofnæmisviðbrögð (bráðaofnæmi) koma fram verður strax að hætta inndælingu.
English: The osmolality of the formulation buffer ranges between 59 and 65 10% mOsm/kg H2O.
Icelandic: Osmólalstyrkur jafnalausnarinnar er á bilinu 59 til 65 10% mOsm/kg H2O.
English: What OBIZUR is and what it is used for
Icelandic: Upplýsingar um OBIZUR og við hverju það er notað
English: The educational programme is aimed to minimize the risk of dose dispensing errors.
Icelandic: Fræðsluáætlunin miðar að því að draga úr hættunni á rangri skömmtun lyfja.
English: A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with Factor VIII activity above a pre-specified target.
Icelandic: Jákvæð svörun var þegar blæðing hafði stöðvast eða minnkað, klínískur bati kom fram eða þegar virkni storkuþáttar VIII var meiri en fyrirfram ákveðið markmið.
English: Frequency and Duration of Subsequent Dosing
Icelandic: Tíðni og lengd framhaldsskömmtun ar
English: Your doctor will check your blood Factor VIII to confirm that enough Factor VIII is being given to you.
Icelandic: Læknirinn mun athuga storkuþátt VIII í blóði til að staðfesta að þér hafi verið gefið nægilegt magn af storkuþætti VIII.
English: Initial Dose (Units per kg)
Icelandic: Upphafsskammt ur (einingar á kg)
English: The safety and efficacy of OBIZUR for the treatment of serious bleeding episodes in subjects with acquired haemophilia with autoimmune inhibitory antibodies to human Factor VIII was investigated in a prospective, non-randomised, open-label trial of 28 subjects (18 Caucasian, 6 Black, and 4 Asian).
Icelandic: Öryggi og verkun OBIZUR til meðferðar á alvarlegum blæðingarköstum hjá sjúklingum með áunna dreyrasýki með hamlandi sjálfsmótefnum gegn manna storkuþætti VIII var rannsakað í framskyggnri, óslembaðri, opinni rannsókn hjá 28 þátttakendum (18 hvítum, 6 svörtum og 4 asískum).
English: Do not over tighten (Figure D).
Icelandic: Ekki herða of mikið (Mynd D).
English: If you forget to use OBIZUR
Icelandic: Ef gleymist að nota OBIZUR
English: The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials.
Icelandic: Í framleiðsluferlinu eru ekki notaðar vörur úr mannasermi og mannaprótíni né önnur efni unnin úr dýrum.
English: Three of the five subjects had no detectable anti-porcine Factor VIII titres post-treatment (< 0.6 BU/mL based on the last reported result), two subjects had a detectable anti-porcine Factor VIII titre (≥ 0.6 BU/mL).
Icelandic: Þrír af fimm þátttakendum höfðu enga mælanlega títra gegn storkuþætti VIII úr svínum eftir meðferð (< 0,6 BU/ml miðað við síðustu tilkynntu niðurstöðu), tveir þátttakendur voru með mælanlegan títra gegn storkuþætti VIII úr svínum (≥ 0,6 BU/ml).
English: - The solvent is 1 ml sterilised water for injections.
Icelandic: - Leysirinn er 1 ml sæft vatn fyrir stungulyf.
English: Activated Factor VIII acts as a co-factor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X, which ultimately converts prothrombin into thrombin.
Icelandic: Virkjaður storkuþáttur VIII verkar sem fylgiþáttur fyrir virkjaðan storkuþátt IX við að hraða umbreytingu storkuþáttar X yfir í virkjað form storkuþáttar X, sem breytir að lokum prótrombíni í trombín.
English: The median number of daily infusions per subject was 1.76 (range: 0.2 to 5.6).
Icelandic: Miðgildi fjölda daglegra innrennsla á þátttakanda var 1,76 (á bilinu: 0,2 til 5,6).
English: OTHER Baxalta Logo
Icelandic: ANNAÐ Kennimerki Baxalta
English: The healthcare professionals training material shall contain the following key elements:
Icelandic: Efni til þjálfunar fyrir heilbrigðisstarfsfólk skal innihalda eftirfarandi lykilatriði:
English: The BHK cells are cultured in media that contains fetal bovine serum.
Icelandic: BHK-frumurnar eru ræktaðar í æti sem inniheldur sermi úr nautgripafóstrum.
English: These antibodies have less neutralizing effect against OBIZUR than against human Factor VIII.
Icelandic: Þessi mótefni hafa minni hlutleysandi áhrif gegn OBIZUR en gegn manna storkuþætti VIII.
English: Use in children and adolescents below 18 years with congenital or in rare cases of acquired haemophilia is currently not approved.
Icelandic: Notkun hjá börnum og unglingum til 18 ára með meðfædda eða mjög sjaldgæfa áunna dreyrasýki hefur ekki enn verið samþykkt.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Icelandic: Mjög algengar (≥1/10), 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), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Icelandic: Hvert hettuglas inniheldur 4,4 mg (198 mmól) af natríum í ml af blandaðri lausn.
English: The Factor VIII/von Willebrand factor complex consists of two molecules (Factor VIII and von Willebrand factor) with different physiological functions.
Icelandic: Storkufléttan storkuþáttur VIII/von Willebrands samanstendur af tveimur sameindum (storkuþætti VIII og von Willebrands-storkuþætti) sem hafa ólíka lífeðlisfræðilega verkun.
English: The effects of higher than recommended doses of OBIZUR have not been characterised.
Icelandic: Áhrifum af hærri en ráðlögðum skömmtum af OBIZUR hefur ekki verið lýst.
English: Driving and using machines OBIZUR has no influence on your ability to drive and use machines.
Icelandic: Akstur og notkun véla OBIZUR hefur engin áhrif á hæfni til aksturs og notkunar véla.
English: AUC0-∞ (%·t)
Icelandic: AUC0t (%t)
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) are possible and may progress to severe anaphylaxis (including shock) (see section 4.4).
Icelandic: Ofnæmi eða ofnæmisviðbrögð (sem geta verið ofsabjúgur, sviði og stingir á stungustað, hrollur, andlitsroði, útbreiddur ofsakláði, höfuðverkur, ofsakláði, lágþrýstingur, svefnhöfgi, ógleði, órói, hraðtaktur, þyngsli fyrir brjósti, náladofi, uppköst og önghljóð) eru hugsanleg og geta í sumum tilfellum þróast yfir í alvarlegt bráðaofnæmi (þ.m.t. lost) (sjá kafla 4.4).
English: OBIZUR has no or negligible influence on the ability to drive and use machines.
Icelandic: OBIZUR hefur engin eða óveruleg áhrif á hæfni til aksturs og notkunar véla.
English: Positive test for inhibitory antibodies against porcine Factor VIII (see section 4.4)
Icelandic: Jákvætt próf fyrir hamlandi mótefnum gegn storkuþætti VIII úr svínum (sjá kafla 4.4)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1035/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/15/1035/001
English: The MAH shall ensure that in each Member State where Obizur is marketed, all healthcare professionals who are expected to prescribe and dispense Obizur have access to/are provided with the following educational package:
Icelandic: Markaðsleyfishafi skal tryggja að í hverju aðildarríki þar sem OBIZUR er markaðssett fái allir heilbrigðisstarfsmenn sem búast má við að ávísi og skammti OBIZUR aðgang að eða afhentan eftirfarandi fræðslupakka:
English: If any of these symptoms occur, the injection should be stopped.
Icelandic: Ef vart verður við einhver þessara einkenna skal hætta inndælingu.
English: The dose, frequency, and duration of the therapy with OBIZUR depend on the location, extent and severity of the bleeding episode, target Factor VIII activity, and on the patient´s clinical condition.
Icelandic: Skammtur, tíðni og tímalengd meðferðar með OBIZUR fer eftir staðsetningu, umfangi og alvarleika blæðingarkasta, virkni markþáttar VIII og klínísku ástandi sjúklingsins.
English: Talk to your doctor if you are on a controlled sodium diet.
Icelandic: Ráðfærðu þig við lækninn ef þú ert á natríumskertu fæði.
English: Of those subjects treated with OBIZUR as first-line therapy, defined as no immediate previous use of anti-haemorrhagic agents prior to the first OBIZUR treatment, 16/17 (94%) had eventual treatment success reported.
Icelandic: Af þeim þátttakendum sem fengu OBIZUR sem fyrsta meðferðarvalkost, sem skilgreindir voru sem þeir sem ekki höfðu notað blæðingarlyf rétt fyrir fyrstu meðferðina með OBIZUR, tilkynntu 16/17 (94%) um endanlegan árangur meðferðarinnar.
English: All initial bleeding episodes had a positive response to treatment at 24 hours after initial dosing as assessed by the primary investigator.
Icelandic: Öll upphafsblæðingarköst sýndu fram á jákvæða svörun við meðferðinni 24 klst. eftir upphafsskammt að mati aðalrannsakanda.
English: Known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients listed in section 6.1.
Icelandic: Þekkt bráðaofnæmi fyrir virka efninu, hamstraprótíni eða einhverju hjálparefnanna sem talin eru upp í kafla 6.1.
English: • Do not administer OBIZUR in the same tubing or container with other medicinal products for injection.
Icelandic: Gefið ekki OBIZUR í sömu slöngu eða íláti með öðrum lyfjum til inndælingar.
English: Dose (U/kg)
Icelandic: Skammtu r (e./kg)
English: Immediately after release in the patient's circulation, Factor VIII binds to von Willebrand factor (vWF).
Icelandic: Strax eftir að lyfið er komið út í blóðrás sjúklingsins, binst storkuþáttur VIII við von Willebrands-storkuþátt (vWF).
English: Use immediately or within 3 hours after reconstitution.
Icelandic: Notið strax eða innan 3 klst.
English: In addition to response to treatment, the overall treatment success was determined by the investigator based on his/her ability to discontinue or reduce the dose and/or dosing frequency of OBIZUR.
Icelandic: Til viðbótar við svörun við meðferð, var heildarárangur meðferðarinnar metinn af rannsakandanum á grundvelli getu hans/hennar til að stöðva eða minnka skammtinn og/eða tíðni skammta af OBIZUR.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Icelandic: Taflan hér að neðan er sett fram samkvæmt MedDRA flokkunarkerfinu (SOC og viðeigandi heiti).
English: How to store OBIZUR
Icelandic: Hvernig geyma á OBIZUR
English: If you use more OBIZUR than recommended, tell your doctor as soon as possible.
Icelandic: Ef þú notar meira af OBIZUR en mælt er fyrir um skaltu tafarlaust hafa samband við lækninn.
English: Usually, the replacement therapy with OBIZUR is a temporary treatment until bleeding is resolved or the antibodies against your own Factor VIII are eradicated.
Icelandic: Venjulega er uppbótarmeðferðin með OBIZUR tímabundin meðferð þar til blæðingar stöðvast eða mótefnum gegn þínum eigin storkuþætti VIII hefur verið eytt.
English: The product is for in-patient administration only.
Icelandic: Lyfið er eingöngu ætlað inniliggjandi sjúklingum.
English: Do not remove the vial adapter from the package.
Icelandic: Ekki taka millistykkið fyrir hettuglasið úr pakkningunni.
English: Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient.
Icelandic: Mælingar á virkni storkuþáttar VIII skulu alltaf framkvæmdar með sömu mæliaðferð hjá hverjum sjúklingi.
English: Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR.
Icelandic: Hemlatítrar sem voru allt að 29 Bethesda-einingar voru skráðir í upphafi þó einstaklingar hafi brugðist jákvætt við OBIZUR.
English: Type of Bleeding Target Factor VIII Trough Activity (Units per dL or % of normal)
Icelandic: Minnsta virkni markþáttar VI II (einingar á dl eða % af eðlilegu)
English: Do not use this medicine after the expiry date which is stated on the carton, on the vial and on the pre-filled syringe after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni, hettuglasinu eða áfylltu sprautunni á eftir EXP.
English: The length of treatment depends on clinical judgement.
Icelandic: Lengd meðferðar fer eftir klínísku mati.