FrancophonIA/ELRC3.0 huggingface dataset:
English: When infused into a patient with haemophilia, factor VIII binds to patient's von Willebrand factor.
Danish: Ved indgift til en patient med hæmofili binder faktor VIII sig til patientens von Willebrand faktor.
English: Pharmacotherapeutic group: antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, blodkoagulationsfaktor VIII, ATC-kode: B02BD02.
English: Wipe the rubber stopper on the vial with an alcohol swab and allow the stopper to air dry before use.
Danish: Rengør gummiproppen på hætteglasset med en spritserviet og lad proppen lufttørre før brug.
English: Headache very common
Danish: Meget almindelig
English: One IU of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Danish: 1 IE af faktor VIII-aktivitet svarer til indholdet af faktor VIII i 1 ml normal human plasma.
English: The pharmacokinetics (PK) of Jivi was compared to that of factor VIII in a crossover Phase I study.
Danish: Farmakokinetikken for Jivi blev sammenlignet med farmakokinetikken for faktor VIII i et fase I-overkrydsningsstudie.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Degree of haemorrhage/Type of surgical procedure
Danish: Blødningsgrad/ Type af kirurgi
English: After reconstitution the solution is clear and colourless and then drawn back into the syringe.
Danish: Opløsningen fremstår som en klar og farveløs væske efter rekonstitution, som dernæst skal trækkes tilbage i sprøjten.
English: For prophylaxis the dose is 45-60 IU/kg every 5 days.
Danish: Den profylaktiske dosis er 45-60 IE/kg hver 5. dag.
English: A total of 73 previously treated pediatric patients (44 subjects < 6 years and 29 subjects 6 to <12 years) received prophylaxis treatment twice weekly, every 5 days or every 7 days in the phase III study.
Danish: I alt 73 tidligere behandlede pædiatriske patienter (44 personer < 6 år og 29 personer -6 til < 12 år) fik profylaktisk behandling 2 gange ugentligt, hver 5. dag eller hver 7. dag i fase III-studiet.
English: Each single package of Jivi contains:
Danish: Hver enkeltpakning med Jivi indeholder:
English: Site-specific PEGylation reduces clearance of factor VIII resulting in an extended half-life while maintaining the normal functions of the B-domain deleted rFVIII molecule (see section 5.2).
Danish: Site-specifik PEGylering reducerer clearance af faktor VIII, som fører til en forlænget halveringstid, mens den normale funktion af rekombinant faktor VIII-molekylet uden B-domæne opretholdes (se pkt.
English: What you need to know before you use Jivi
Danish: Det skal du vide, før du begynder at bruge Jivi
English: The reconstituted product must be filtered by using the vial adapter before injection to remove any possible particles in the solution.
Danish: Det opløste lægemiddel skal filtreres ved brug af forbindelsesstykket til hætteglasset før injektion for at fjerne eventuelle partikler i opløsningen.
English: • previously developed factor VIII inhibitors to a different product.
Danish: • tidligere dannet antistoffer mod faktor VIII i forbindelse med et andet lægemiddel.
English: Stop injecting the product immediately and get medical help at once if this occurs.
Danish: Hold straks op med injicere præparatet og få straks lægehjælp, hvis dette sker.
English: This medicine may be stored at room temperature (up to 25 °C) for up to 6 months when you keep it in its outer carton.
Danish: Dette lægemiddel kan opbevares ved stuetemperatur (op til 25 °C) i op til 6 måneder når du opbevarer det i yderkartonen.
English: Each vial of Jivi contains nominally 250 or 500 or 1000 or 2000 or 3000 IU damoctocog alfa pegol.
Danish: Hvert hætteglas med Jivi indeholder nominelt 250 eller 500 eller 1.000 eller 2.000 eller 3.000 IE damoctocog alfa pegol.
English: If the calculated dose fails to attain the expected factor VIII levels or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating factor VIII-inhibitor or anti-PEG antibodies in the patient should be suspected (see section 4.4).
Danish: Hvis den beregnede dosis ikke medfører at de forventede faktor VIIIniveauer opnås, eller hvis blødningen ikke kontrolleres efter administration af den beregnede dosering, skal der mistænkes en tilstedeværelse af faktor VIII-hæmmer eller anti-PEG-antistoffer i kredsløbet (se pkt.
English: Jivi is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level.
Danish: Jivi indsprøjtes i en blodåre over 2 til 5 minutter, afhængigt af den samlede mængde og dit velbefindende.
English: The median dose for all prophylaxis regimens was 46.9 IU/kg/injection.
Danish: Den mediane dosis for alle profylakseprogrammer var 46,9 IE/kg/injektion.
English: • allergic reactions (may present as hives, generalized urticaria, tightness of the chest, wheezing,
Danish: • allergiske reaktioner (kan vise sig som nældefeber, generaliseret urticaria, trykken for brystet,
English: Other medicines and Jivi
Danish: Brug af anden medicin sammen med Jivi
English: A field study has indicated that the factor VIII activity of Jivi can be accurately measured in plasma using either a validated chromogenic substrate (CS) assay or a one-stage (OS) clotting assay using specific reagents.
Danish: Et feltstudie har indikeret, at faktor VIII-aktiviteten af Jivi kan måles akkurat i plasma med enten en valideret, kromogensubstratanalyse (chromogenic substrate), eller en 1-trins-(one-stage) koagulationsanalyse med specifikke reagenser.
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Danish: Indsprøjt opløsningen i en vene i løbet af 2 - 5 minutter, mens du holder øje med kanylens position.
English: The median (range) dose per injection was 31.7 IU/kg (14; 62).
Danish: Mediandosis pr. injektion var 31,7 IE/kg (interval: 14; 62).
English: The use of Jivi in children below 12 years is not indicated (see section 4.2, for information on paediatric use).
Danish: Anvendelsen af Jivi til børn under 12 år er ikke indiceret (se pkt.
English: How Jivi is given
Danish: Sådan gives Jivi
English: • 45-60 IU per kg body weight every 5 days or
Danish: • 45-60 IE pr. kg legemsvægt hver 5. dag eller
English: When using an in vitro activated partial thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay, which can result in over- or under-estimation of factor VIII activity.
Danish: Når der anvendes in vitro-aktiveret partiel thromboplastintid (aPTT)-baseret 1-trinskoagulationsanalyse for at bestemme faktor VIII-aktiviteten i patienternes blodprøver, kan faktor VIII-aktiviteten i plasma være signifikant påvirket, både af typen af aPTT-reagens og referencestandarden, der anvendes i analysen.
English: The median (range) dose was 37.3 (18; 66) IU/kg/injection.
Danish: Mediandosis var 37,3 (interval: 18; 66) IE/kg/injektion.
English: Anti¬PEG antibodies
Danish: Anti-PEG-antistoffer
English: Inject the solvent by slowly pushing down on the plunger rod (G).
Danish: Indsprøjt opløsningen ved langsomt at trykke stempelstangen ned (G).
English: MRTIV (h) Vss (dL/kg) CL (dL/h/kg)
Danish: MRTIV (t) Vss (dl/kg) CL (dl/t/kg)
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Jivi (see section 5.1).
Danish: Der kan udvikles neutraliserende antistoffer (inhibitorer) hos patienter med hæmofili A, som behandles med faktor VIII, herunder med Jivi (se pkt.
English: Phase III (Paediatric): Pharmacokinetics, safety, and efficacy of Jivi for three prophylaxis regimens (twice weekly, every 5 and every 7 days) and treatment of breakthrough bleeds were evaluated in a multi-national, uncontrolled, open-label trial in 73 paediatric patients (<12 years of age) during a period of 50 EDs and at least 6 months.
Danish: Fase III (pædiatrisk): Farmakokinetik, sikkerhed og virkning for 3 profylaktiske behandlingsprogrammer (2 gange ugentligt hver 5. og hver 7. dag) og behandling af gennembrudsblødninger blev evalueret i et multinationalt, ikke kontrolleret, åbent studie med 73 pædiatriske patienter (< 12 år) i løbet af en periode på 50 ED'er og i mindst 6 måneder.
English: Table 3: Pharmacokinetic parameters (geometric mean (%CV) and arithmetic mean (SD)) for Jivi following a single 60 IU/kg dose based on chromogenic assay.
Danish: Tabel 3: Farmakokinetiske parametre (geometrisk gennemsnit (%CV) og aritmetisk gennemsnit (SD)) for Jivi efter en enkelt 60 IE/kg dosis, baseret på kromogenanalyse
English: Repeat injection every 8 to 24 hours until threat is resolved.
Danish: Gentag injektionen hver 8.-24. time, indtil den kritiske tilstand er ophørt.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days (ED) but continues throughout life although the risk is uncommon.
Danish: Denne risiko er størst i løbet af de første 50 eksponeringsdage (ED), men fortsætter i hele livet, selvom denne risiko er ikke almindelig.
English: Driving and using machines Jivi has no influence on your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Jivi påvirker ikke din evne til at føre motorkøretøj og betjene maskiner.
English: The median (Q1; Q3) recovery was 2.6 (2.3; 3.0) by chromogenic assay.
Danish: Median (Q1; Q3) bedring var 2,6 (2,3; 3,0) ved kromogenanalyse.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels or absence of factor VIII:C that results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Danish: Sygdommen skyldes et nedsat niveau eller fravær af faktor VIII:C, som medfører blødning i led, muskler eller indre organer, enten spontant eller som følge af et traume i forbindelse med en ulykke eller et kirurgisk indgreb.
English: The overall median (Q1; Q3) total ABR was 1.17 (0.0; 4.3) and 0.6 (0.0: 3.2) for spontaneous bleeds in the combined prophylaxis groups and total ABR was 33.0 in the on-demand group.
Danish: Den samlede mediane (Q1; Q3) totale ABR var 1,17 (0,0; 4,3) og 0,6 (0,0; 3,2) for spontane blødninger i de kombinerede profylaksegrupper, og totalt ABR var 33,0 i gruppen med behovsbehandling.
English: Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).
Danish: Behandling af og profylakse mod blødning hos tidligere behandlede patienter ≥ 12 år med hæmofili A (medfødt faktor VIII-mangel).
English: The active substance, damoctocog alfa pegol, is a site specifically PEGylated B-domain deleted recombinant human coagulation factor VIII, produced in baby hamster kidney cells (BHK), with a 60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety.
Danish: Det aktive stof, damoctocog alfa pegol, er en site-specifik PEGyleret rekombinant human koagulationsfaktor VIII (faktor VIII) uden B-domæne, fremstillet i nyreceller fra hamsterunger (baby-hamster kidney cells, BHK), med en 60 kDa forgrenet polyethylenglycol-enhed (to 30 kDa PEG).
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Jivi.
Danish: En detaljeret beskrivelse af hvordan Jivi klargøres og indgives, findes i den indlægsseddel, der følger med Jivi.
English: The median dose for prophylaxis was 47.7 IU/kg.
Danish: Den mediane dosis for profylakse var 47,7 IE/kg.
English: Table 4: PK parameters (geometric mean [%CV]) based on population PK model, using chromogenic assay.
Danish: Tabel 4: Farmakokinetiske parametre (geometrisk gennemsnit [% CV]) baseret på populationsfarmakokinetisk model, ved brug af kromogenanalyse
English: 1 vial with powder, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter and 1 venipuncture set.
Danish: 1 hætteglas med pulver, 1 fyldt injektionssprøjte med 2,5 ml vand til injektionsvæsker, 1 forbindelsesstykke til hætteglas og 1 venepunktursæt.
English: Filtering is achieved by using the vial adapter.
Danish: Filtreringen finder sted ved at bruge forbindelsesstykket til hætteglasset.
English: The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride dihydrate, polysorbate 80, acetic acid glacial and water for injections.
Danish: Øvrige indholdsstoffer: saccharose, histidin, glycin, natriumchlorid, calciumchloriddihydrat, polysorbat 80, eddikesyre og vand til injektionsvæsker.
English: • one vial with powder (10 mL clear type 1 glass vial with grey bromobutyl rubber blend stopper and aluminium seal)
Danish: • et hætteglas med pulver (10 ml klart type 1 glas hætteglas med en grå brombutylgummiprop og aluminiumsforsegling)
English: Hold the pre-filled syringe of solvent upright.
Danish: Hold den fyldte injektionssprøjte med solvensen lodret.
English: Jivi is used to treat and prevent bleeding in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency).
Danish: Jivi anvendes til behandling og forebyggelse af blødning hos tidligere behandlede voksne og unge i alderen fra 12 år med hæmofili A (medfødt faktor VIII mangel).
English: AUCnorm (kg.h/dL) t1/2 (h) Vss (dL/kg) CL (dL/h/kg)
Danish: AUCnorm (t*kg/dl) t1/2 (t) Vss (dl/kg) CL (dl/t/kg)
English: • one pre-filled syringe with 2.5 mL solvent (clear type 1 glass cylinder syringe with grey bromobutyl rubber blend stopper)
Danish: • en fyldt injektionssprøjte med 2,5 ml solvens (klart glas type 1-cylindersprøjte med grå brombutylgummiprop)
English: No triggers or predictors of the immune response to PEG could be identified.
Danish: Der kunne ikke identificeres nogen udløsere eller indikatorer for PEG.
English: • a separate plunger rod
Danish: • en separat stempelstang
English: Jivi 250 IU powder and solvent for solution for injection
Danish: Jivi 250 IE pulver og solvens til injektionsvæske, opløsning
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning.
English: Ask your pharmacist or physician how to throw away medicines you no longer use.
Danish: Spørg apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON TIL EN MULTIPAKNING (UDEN BLÅ BOKS)
English: The median (Q1; Q3) ABR during prophylaxis was 2.09 (0.0; 6.1) for all bleeds and 0.0 (0;0 4.2) for spontaneous bleeds as compared to 23.4 (18; 37) total bleeds in the on-demand group.
Danish: Den mediane (Q1; Q3) ABR under profylaksen var 2,09 (0,0; 6,1) for alle blødninger, og 0,0 (0,0; 4,2) for spontane blødninger, sammenlignet med 23,4 (18; 37) totale blødninger i gruppen med behovsbehandling.
English: Use only the components (vial adapter, pre-filled syringe containing solvent and venipuncture set) provided with each package of this medicine.
Danish: Anvend kun de dele, der leveres med hver pakning af dette lægemiddel (forbindelsesstykke til hætteglas, fyldt injektionssprøjte indeholdende solvens og venepunktursæt).
English: Jivi powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) in the prefilled-syringe and the vial adapter.
Danish: Jivi-pulver må kun opløses i den medfølgende solvens (2,5 ml vand til injektionsvæsker) i den fyldte injektionssprøjte og forbindelsesstykket til hætteglasset.
English: EXP (End of the 6 month period, if stored up to 25 °C): ................ Do not use after this date.
Danish: EXP (Slutningen af 6-måneders perioden ved opbevaring ved temperaturer op til 25 °C): ................
English: Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not been reported.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der er ikke rapporteret interaktioner mellem human koagulationsfaktor VIII (rdna)-produkter og andre lægemidler.
English: • Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Danish: • Opbevar hætteglasset og den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys.
English: For Jivi some silica-based one-stage assays (e.g., APTT-SP, STA-PTT) may underestimate the factor VIII activity of Jivi in plasma samples; some reagents, e.g. with kaolin-based activators, have the potential for overestimation.
Danish: For Jivi kan nogle silica-baserede 1-trins-analyser (f.eks. APTT-SP, STA-PTT) underestimere faktor VIII-aktiviteten af Jivi i plasmaprøver.
English: Damoctocog alfa pegol is a PEGylated form of rFVIII.
Danish: Damoctocog alfa pegol er en PEGyleret form af rekombinant faktor VIII.
English: • Do not refrigerate after reconstitution.
Danish: • Må ikke opbevares i køleskab efter rekonstitution.
English: Hold the vial on end above the vial adapter and syringe (I).
Danish: Hold hætteglasset med bunden i vejret over forbindelsesstykket til hætteglas og injektionssprøjten (I).
English: AUC (IU*h/dL) AUC, norm (h*kg/dL) Cmax (IU/dL) t½ (h)
Danish: AUC (IE*t/dl) AUCnorm (t*kg/dl) Cmax (IE/dl) t½ (t)
English: FVIII inhibitors
Danish: Faktor VIII-inhibitorer
English: A population PK model was developed based on all available factor VIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Danish: Der blev udviklet en populationsfarmakokinetisk model baseret på alle tilgængelige faktor VIIImålinger (fra hyppig farmakokinetisk prøvetagning og alle genfindingsprøver) i løbet af alle de
English: Life-threatening Haemorrhages
Danish: Livstruende Hæmoragi
English: Attach the syringe to the venipuncture set (J).
Danish: Sæt sprøjten på venepunktursættet (J).
English: What is in this leaflet What Jivi is and what it is used for What you need to know before you use Jivi How to use Jivi
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at bruge Jivi Sådan skal du bruge Jivi Bivirkninger
English: Perioperative Management
Danish: Perioperativ behandling
English: Place the powder vial on a firm, non-slip surface.
Danish: Anbring hætteglasset med pulver på en fast, skridsikker overflade.
English: Jivi is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
Danish: Jivi fås i pakningsstørrelser med: - 1 enkeltpakning
English: Detailed instructions for reconstitution and administration of Jivi You will need alcohol swabs, gauze pads, plasters and tourniquet.
Danish: Du skal bruge spritservietter, kompresser, plastre og årepresse.
English: Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Danish: Jivi 250 IE pulver og solvens til injektionsvæske, opløsning Jivi 500 IE pulver og solvens til injektionsvæske, opløsning Jivi 1.000 IE pulver og solvens til injektionsvæske, opløsning Jivi 2.000 IE pulver og solvens til injektionsvæske, opløsning Jivi 3.000 IE pulver og solvens til injektionsvæske, opløsning
English: Low post-injection factor VIII levels in the absence of detectable factor VIII inhibitors indicate that loss of drug effect is likely due to anti-PEG antibodies; in such cases Jivi should be discontinued and patients switched to a previously effective factor VIII product.
Danish: Lave faktorVIII-niveauer efter injektion, når der ikke er detekterbare faktorVIII-inhibitorer til stede, indikerer, at manglende virkning af lægemidlet sandsynligvis skyldes anti-PEG-antistoffer.
English: • a pre-filled syringe of solvent
Danish: • en fyldt injektionssprøjte med solvens
English: Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Danish: Fastgør den fyldte injektionssprøjte til forbindelsesstykket gevind ved at skrue med uret (F).
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Danish: Patienterne skal informeres om straks at seponere lægemidlet og kontakte lægen, hvis der opstår symptomer på overfølsomhed.
English: How to use Jivi
Danish: Sådan skal du bruge Jivi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER
English: Peel off the paper cover on the plastic housing of the vial adapter.
Danish: Fjern papirhætten af plastikhylstret på forbindelsesstykket til hætteglasset.
English: Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Danish: Jivi 500 IE pulver og solvens til injektionsvæske, opløsning Jivi 1.000 IE pulver og solvens til injektionsvæske, opløsning Jivi 2.000 IE pulver og solvens til injektionsvæske, opløsning Jivi 3.000 IE pulver og solvens til injektionsvæske, opløsning
English: Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Danish: Hold på injektionssprøjten cylinder og knæk injektionssprøjtens hætte af (D).
English: Jivi 500
Danish: 2,5 ml
English: PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Danish: PEGyleret rekombinant human koagulationsfaktor VIII (damoctocog alfa pegol)
English: Dizziness common
Danish: Ikke almindelig
English: Abdominal pain, Nausea, Vomiting common Skin and subcutaneous tissue disorders Erythema***, Rash**** common Pruritus uncommon
Danish: Erytem***, udslæt**** Almindelig Pruritus
English: INFORMATION IN BRAILLE Jivi 250
Danish: INFORMATION I BRAILLESKRIFT Jivi 250
English: At least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
Danish: Gentag injektionen hver 24.-48. time i mindst én dag, indtil blødningsepisoden, der er kendetegnet ved smerter, er gået i ro eller opheling er nået.
English: PK parameter(unit) 12-<18 years N=12
Danish: 12-< 18 år N = 12
English: Blood and lymphatic system disorders FVIII inhibition
Danish: Blod og lymfesystem
English: INFORMATION IN BRAILLE Jivi 500
Danish: INFORMATION I BRAILLESKRIFT Jivi 500
English: What Jivi contains
Danish: Jivi indeholder:
English: Single dose only.
Danish: Kun til engangsbrug.
English: INFORMATION IN BRAILLE Jivi 3000
Danish: INFORMATION I BRAILLESKRIFT Jivi 3.000
English: The active substance is PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol).
Danish: Aktivt stof: PEGyleret rekombinant human koagulationsfaktor VIII uden B-domæne (damoctocog alfa pegol).
English: INFORMATION IN BRAILLE Jivi 1000
Danish: INFORMATION I BRAILLESKRIFT Jivi 1.000
English: 4.7 Effects on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Jivi påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: Jivi is provided as a powder and solvent for solution for injection.
Danish: Jivi findes som pulver og solvens (væske, som pulveret skal opløses i inden indsprøjtningen) til injektionsvæske, opløsning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 250 IU contains 100 IU damoctocog alfa pegol per mL after reconstitution (250 IU / 2.5 mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Jivi 250 IE indeholder 100 IE damoctocog alfa pegol pr. ml efter rekonstitution (250 IE / 2,5 ml).
English: • a venipuncture set
Danish: • et venepunktursæt