FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall survival results showed a HR=0.78 (56.4 months versus 45.8 months for the OFA+FC arm versus FC arm; 95% CI: 0.56-1.09; p=0.1410).
Danish: De overordnede resultater for overlevelse viste HR=0,78 (56,4 måneder versus 45,8 måneder for OFA+FC-armen versus FC-armen; 95 % konfidensinterval: 0,56-1,09; p=0,1410).
English: • fever, coughing, difficulty breathing, wheezing, possible symptoms of infections of the lungs or airways (respiratory tract) including pneumonia
Danish: • feber, hoste, vejrtrækningsbesvær og hvæsen kan være mulige symptomer på en lunge- eller luftvejsinfektioner, herunder lungebetændelse
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min).
Danish: Der anbefales ikke dosisjustering ved mildt til moderat nedsat nyrefunktion (kreatininclearance på >30 ml/minut).
English: *If the previous infusion was completed without severe infusion-related ADRs.
Danish: *Hvis den forrige infusion blev afsluttet uden alvorlige infusionsrelaterede bivirkninger.
English: IGHV mutated & ZAP-70 positive (n=35)
Danish: IGHV muteret & ZAP-70 positiv (n=35)
English: Previously untreated CLL and relapsed CLL:
Danish: Tidligere ubehandlet CLL og recidiverende CLL:
English: *These events are likely attributable to ofatumumab in the setting of an infusion-related reaction and typically occur after the start of infusion and within 24 hours after the completion of the infusion (see section 4.4).
Danish: Bivirkningerne optræder som regel i starten af infusionen og inden for 24 timer efter infusionens afslutning (se pkt.
English: If an infusion-related ADR is observed during an infusion, see below section “Dose modification and reinitiation of therapy after infusion-related ADRs”.
Danish: I tilfælde af en infusionsrelateret bivirkning under en infusion, se afsnittet "Dosisjustering og genoptagelse af behandling efter infusionsrelaterede bivirkninger" nedenfor.
English: 3 vials
Danish: 3 hætteglas
English: *If the second infusion was completed without severe infusion-related ADRs.
Danish: *Hvis den anden infusion blev afsluttet uden alvorlige infusionsrelaterede bivirkninger.
English: Do not use the Arzerra concentrate if there is discolouration.
Danish: Arzerra-koncentratet må ikke anvendes, hvis det er misfarvet.
English: Patients received either Arzerra as monthly intravenous infusions (cycle 1: 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with chlorambucil (10 mg/m2 orally on days 1-7 every 28 days) or chlorambucil alone (10 mg/m orally on days 1-7 every
Danish: Patienter fik enten Arzerra som en månedlig intravenøs infusion (cyklus 1: 300 mg på dag 1 og 1000 mg på dag 8; efterfølgende cyklusser: 1000 mg på dag 1, hver 28. dag) i kombination med chlorambucil (10 mg/m oralt på dag 1-7, hver 28. dag) eller chlorambucil alene (10 mg /m oralt på dag 1-7, hver 28. dag).
English: • slow heart beat
Danish: • langsom puls
English: Other medicines and Arzerra
Danish: Brug af anden medicin sammen med Arzerra
English: ***Corticosteroid may be reduced for subsequent infusions at the discretion of the physician, if a severe infusion-related ADR did not occur with the preceding infusion(s).
Danish: ***Lægen kan vurdere at reducere kortikosteroid for de efterfølgende infusioner, hvis der ikke forekom en alvorlig infusionsrelateret bivirkning.
English: These may affect up to 1 in 10 people:
Danish: Kan forekomme hos op til 1 ud af 100 personer:
English: IGHV unmutated & ZAP-70 negative (n=27)
Danish: IGHV ikke-muteret & ZAP-70 negativ (n=27)
English: - The other ingredients are arginine, sodium acetate (E262), sodium chloride, polysorbate 80
Danish: - Øvrige indholdsstoffer: arginin, natriumacetat (E262), natriumchlorid, polysorbat 80 (E433),
English: IGHV unmutated & ZAP-70 positive (n=122)
Danish: IGHV ikke-muteret & ZAP-70 positiv (n=122)
English: In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour when the patient's condition is stable.
Danish: Ved en alvorlig bivirkning skal infusionen afbrydes og genoptages med 12 ml/time, når patientens tilstand er stabil.
English: If an infusion-related ADR is observed during infusion, see below section “Dose modification and reinitiation of therapy after infusion-related ADRs”.
Danish: I tilfælde af en infusionsrelateret bivirkning under infusionen, se afsnittet "Dosisjustering og genoptagelse af behandling efter infusionsrelaterede bivirkninger" nedenfor.
English: PFS based on local (investigator) assessment was consistent with the primary endpoint and resulted in a ~11-month improvement in median PFS (OFA+FC 27.2 months versus 16.8 months for FC; HR=0.66 (95% CI: 0.51, 0.85, p=0.0009).
Danish: PFS baseret på lokal (investigator-)vurdering var i overensstemmelse med det primære endepunkt og resulterede i en forbedring i median-PFS på ~11 måneder (OFA+FC 27,2 måneder versus 16,8 måneder for FC; HR=0,66 (95 % konfidensinterval: 0,51-0,85; p=0,0009).
English: One ml of concentrate contains 20 mg of ofatumumab.
Danish: Én ml koncentrat indeholder 20 mg ofatumumab.
English: Arzerra is available in packs of 3 vials.
Danish: Arzerra fås i pakninger med 3 hætteglas.
English: • Do not shake; mix diluted solution by gentle inversion.
Danish: • Ryst ikke posen; bland den fortyndede opløsning ved at vende posen roligt op og ned.
English: Bowel obstruction has been reported in patients receiving anti-CD20 monoclonal antibody therapy, including ofatumumab.
Danish: Tarmobstruktion hos patienter, som behandles med monoklonale antistoffer rettet mod CD20, herunder ofatumumab, er rapporteret.
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 50 ml of concentrate (1000 mg of ofatumumab).
Danish: Hvert hætteglas er lukket med en gummiprop og en forsegling af aluminium, og indeholder 50 ml koncentrat (1000 mg ofatumumab).
English: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Danish: Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Storbritannien
English: Ofatumumab plus
Danish: ofatumumab i.v.
English: Refractory CLL
Danish: Refraktær CLL
English: Patient median age was 61 years (range: 27 to 82 years), the majority were male (58%), and all were white.
Danish: Patienternes medianalder var 61 år (interval: 27 til 82 år), størstedelen var mænd (58 %), og alle var hvide.
English: Each glass vial is closed with a rubber stopper and aluminium over-seal, and contains 5 ml of concentrate (100 mg of ofatumumab).
Danish: Hvert hætteglas er lukket med en gummiprop og en forsegling af aluminium, og indeholder 5 ml koncentrat (100 mg ofatumumab).
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Neutropeni, anæmi
English: In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour, once the patient's condition is stable.
Danish: Ved en alvorlig bivirkning skal infusionen afbrydes og genoptages med en hastighed på 12 ml/time, så snart patientens tilstand er stabil.
English: • blue discolouration of the lips and extremities (possible symptoms of hypoxia)
Danish: • blå misfarvning af læber og yderliggende kropsdele, som f.eks. hænder og fødder (mulige
English: Dose modification and reinitiation of therapy after infusion-related ADRs In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption once the patient's condition is stable.
Danish: Dosisjustering og genoptagelse af behandling efter infusionsrelaterede bivirkninger Ved en let til moderat bivirkning skal infusionen afbrydes og genoptages, så snart patientens tilstand er stabil, med halveret hastighed i forhold til hastigheden på afbrydelsestidspunktet.
English: No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min) (see section 5.2).
Danish: Der anbefales ikke dosisjustering ved mildt til moderat nedsat nyrefunktion (kreatininclearance på >30 ml/minut) (se pkt.
English: During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour (see section 6.6).
Danish: Under infusionen bør hastigheden øges hvert 30. minut til maksimalt 200 ml/time (se pkt.
English: Patients received Arzerra as monthly intravenous infusions (cycle 1 300 mg on day 1 and 1000 mg on day 8; subsequent cycles: 1000 mg on day 1 every 28 days) in combination with intravenous bendamustine 90 mg/m on days 1 and 2 every 28 days.
Danish: Patienter fik Arzerra som månedlige intravenøse infusioner (cyklus 1: 300 mg på dag 1 og 1000 mg på dag 8; efterfølgende cyklusser: 1000 mg på dag 1, hver 28. dag) i kombination med intravenøs bendamustin 90 mg/m på dag 1 og 2, hver 28. dag.
English: You will be given medicines such as anti-histamines, steroids or pain relievers to help reduce any reaction.
Danish: Du vil få medicin, som kan være med til at mindske en eventuel reaktion, såsom antihistaminer, steroider eller smertestillende medicin.
English: Previously untreated CLL and relapsed CLL
Danish: Tidligere ubehandlet CLL og recidiverende CLL
English: The Arzerra concentrate must be diluted in sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration, using aseptic technique.
Danish: Før administration skal Arzerra-koncentratet fortyndes i en 9 mg/ml (0,9 %) natriumchloridinjektionsvæske ved brug af aseptisk teknik.
English: Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Danish: Tidligere ubehandlet kronisk, lymfatisk leukæmi (CLL) Arzerra er i kombination med chlorambucil eller bendamustin indiceret til behandling af voksne patienter med CLL, der ikke tidligere har fået behandling, og som ikke er egnet til behandling baseret på fludarabin.
English: Very common symptoms of an infusion-related reaction (may affect more than 1 in 10 people):
Danish: Meget almindelige symptomer på en infusionsrelateret reaktion (kan forekomme hos flere end 1 ud af 10 personer):
English: As a result, ofatumumab clearance values were lower and t½ values were significantly larger after later infusions than after the initial infusion; during repeated weekly infusions, ofatumumab AUC and Cmax values increased more than the expected accumulation based on first infusion data.
Danish: Under de gentagne ugentlige infusioner steg ofatumumabs AUC- og Cmax-værdier mere end den akkumulation, der forventedes ud fra data fra den første infusion.
English: Chlorambuci + Chl
Danish: Chlorambucil Ofatumumab plus Chlorambucil + Chl ClCChlorambuci + CChlorambuci + Chl
English: Patient median age was 61 years (range: 32 to 90 years, 7% were 75 years of age or older), 60% were male and 16%, 55% and 28% of patients were Binet stage A, B and C, respectively.
Danish: Patienternes medianalder var 61 år (interval: 32 til 90 år, 7 % var 75 år eller ældre), 60 % var mænd, og henholdsvis 16 %, 55 % og 28 % af patienterne var Binet-stadie A, B og C. Størstedelen af patienterne (81 %) havde fået 1-2 tidligere behandlingslinjer (hvoraf ca. 50 % havde fået 1 tidligere behandling), og 21 % af patienterne havde tidligere fået rituximab.
English: IgG1 molecules such as ofatumumab are catabolised by ubiquitous proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of ofatumumab.
Danish: IgG1-molekyler som ofatumumab kataboliseres af ubikvitære proteolytiske enzymer, som ikke kun findes i levervæv.
English: No formal studies of Arzerra in patients with renal impairment have been performed.
Danish: Der er ikke udført formelle forsøg med administration af Arzerra til patienter med nedsat nyrefunktion.
English: Infusion rate (ml/hour)
Danish: Efterfølgende infusioner* Infusionshastighed (ml/time) Infusionshastighed (ml/time)
English: Arzerra is available in packs of 1 vial.
Danish: Arzerra fås i pakninger med 1 hætteglas.
English: Check the Arzerra concentrate for particulate matter and discolouration prior to dilution.
Danish: Arzerra-koncentratet skal kontrolleres for fremmedlegemer og misfarvning inden fortyndingen.
English: Relapsed CLL
Danish: Recidiverende CLL
English: Median time to next therapy was longer for the OFA+FC arm versus FC (48.1 months versus 40.1 months; HR: 0.73; 95% CI: 0.51-1.05).
Danish: Mediantiden til næste behandling var længere for armen med OFA+FC versus FC (48,1 måneder versus 40,1 måneder; HR: 0,73; 95 % konfidensinterval: 0,51-1,05).
English: In patients with CLL, tumour lysis syndrome (TLS) may occur with use of Arzerra.
Danish: Der kan opstå tumorlysesyndrom (TLS) hos patienter med CLL, når de får Arzerra.
English: Edetate disodium (E386) Hydrochloric acid (E507) (for pH-adjustment) Water for injections
Danish: Polysorbat 80 (E433) Dinatriumedetat (E386) Saltsyre (E507) (til pH-justering) Vand til injektionsvæsker
English: 8 weekly infusions followed by 4 monthly infusions th dose 827
Danish: 8 ugentlige infusioner efterfulgt af
English: Common symptoms of an infusion-related reaction (may affect up to 1 in 10 people):
Danish: Almindelige symptomer på en infusionsrelateret reaktion (kan forekomme hos op til 1 ud af 10 personer):
English: Uncommon symptoms of an infusion-related reaction (may affect up to 1 in 100 people):
Danish: Ikke almindelige symptomer på en infusionsrelateret reaktion (kan forekomme hos op til 1 ud af 100 personer):
English: If any adverse reactions are observed, infusion rates should be reduced (see section 4.2).
Danish: Hvis der observeres bivirkninger, skal infusionshastigheden nedsættes (se pkt.
English: Gender had a modest effect (12%) on ofatumumab central volume of distribution in a cross-study population analysis, with higher Cmax and AUC values observed in female patients (48% of the patients in this analysis were male and 52% were female); these effects are not considered clinically relevant, and no dose adjustment is recommended.
Danish: Der blev observeret højere værdier af Cmax og AUC hos kvinder (48 % af patienterne i denne analyse var mænd, og 52 % var kvinder).
English: Marketing Authorisation Holder Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR United Kingdom
Danish: Indehaver af markedsføringstilladelsen Novartis Europharm Limited Frimley Business Park Camberley GU16 7SR Storbritannien.
English: How to administer the diluted solution
Danish: Administration af den fortyndede opløsning
English: Sodium chloride
Danish: natriumchloridinjektionsvæske.
English: Talk to your doctor or nurse before you are given Arzerra:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du behandles med Arzerra:
English: Hypersensitivity*
Danish: Hypotension*, hypertension*
English: • anaphylactic reaction including anaphylactic shock, where symptoms include breathlessness or difficulty breathing, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without mild generalised itching, skin reddening, swelling of the face and/or throat, blue discolouration of the lips, tongue or skin
Danish: • anafylaktisk reaktion, herunder anafylaktisk shock, hvor symptomer omfatter åndenød eller vejrtrækningsbesvær, hvæsen eller hoste, ørhed, svimmelhed, ændring i bevidsthedsniveauet,
English: Respiratory, thoracic and mediastinal disorders oropharyngeal pain*, nasal congestion*
Danish: Bronkospasmer*, ubehag i brystet*, orofaryngeal smerte, nasal kongestion*
English: Median time to progression was longer for the OFA+FC arm versus FC (42.1 months versus 26.8 months; HR: 0.63; 95% CI: 0.45-0.87).
Danish: Mediantiden til progression var længere for armen med OFA+FC versus FC (42,1 måneder versus 26,8 måneder; HR: 0,63; 95 % konfidensinterval: 0,45
English: The initial rate of the first infusion of Arzerra should be 12 ml/h.
Danish: Den initiale infusionshastighed ved den første Arzerra-infusion er 12 ml/time.
English: No formal studies of Arzerra in patients with hepatic impairment have been performed.
Danish: Der er ikke udført formelle forsøg med administration af Arzerra til patienter med nedsat leverfunktion.
English: Since ofatumumab may cause foetal B-cell depletion, effective contraception (methods that result in less than 1% pregnancy rates) has to be used during Arzerra therapy and for 12 months after the last Arzerra dose.
Danish: Sikker kontraception (beskyttelse som resulterer i mindre end 1 % graviditetsrate) skal anvendes under behandling med Arzerra og mindst 12 måneder efter den sidste dosis Arzerra, da ofatumumab kan forårsage føtal B-celle-depletion.
English: • if you are allergic (hypersensitive) to ofatumumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke behandles med Arzerra: • hvis du er allergisk over for ofatumumab eller et af de øvrige indholdsstoffer i dette lægemiddel
English: • Withdraw and discard 100 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Danish: • Udtag og kassér 100 ml fra en pose med 1000 ml 9 mg/ml (0,9 %)
English: During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h (see section 6.6).
Danish: Infusionshastigheden bør øges hvert 30. minut til maksimalt 400 ml/time (se pkt.
English: 1000 mg dose - Use one 1000 mg/50 ml vial (50 ml total, 50 ml per vial):
Danish: Dosis på 1000 mg - Brug én 1000 mg/50 ml hætteglas (50 ml i alt, 50 ml pr. hætteglas):
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, United Kingdom Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Danish: Glaxo Operations UK Limited (under forretningsnavnet Glaxo Wellcome Operations), Harmire Road, Barnard Castle, County Durham, DL12 8DT, Storbritannien.
English: 2000 mg dose - Use two 1000 mg/50 ml vials (100 ml total, 50 ml per vial):
Danish: Dosis på 2000 mg - Brug to 1000 mg/50 ml hætteglas (100 ml i alt, 50 ml pr. hætteglas):
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion.
Danish: Type I-hætteglas af klart glas med en gummiprop af bromobutyl og forsegling af aluminium, som indeholder 5 ml koncentrat til infusionsvæske, opløsning.
English: • Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Danish: • Udtag og kassér 50 ml fra en pose med 1000 ml 9 mg/ml (0,9 %)
English: • difficulty and pain when passing urine, exaggerated sense of needing to urinate, urinary tract infections
Danish: • vandladningsbesvær eller smerter forbundet vandladning, overdreven trang til vandladning, urinvejsinfektioner
English: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 50 ml of concentrate for solution for infusion.
Danish: Type I-hætteglas af klart glas med en gummiprop af bromobutyl og forsegling af aluminium, som indeholder 50 ml koncentrat til infusionsvæske, opløsning.
English: Lymphadenopathy 50% improvement Complete resolution Splenomegaly 50% improvement Complete resolution Hepatomegaly 50% improvement Complete resolution Haemoglobin <11 g/dl at baseline to >11 g/dl post baseline Platelet counts ≤100x10 increase or >100x10 Neutrophils <1x10
Danish: Forbedring på 50 % Komplet resolution Splenomegali Forbedring på 50 % Komplet resolution Hepatomegali
English: Arzerra 100 mg concentrate for solution for infusion 300 mg dose: Use 3 vials (15 ml total, 5 ml per vial) - Withdraw and discard 15 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection; - Withdraw 5 ml of ofatumumab from each of 3 vials and inject into the 1000 ml bag; - Do not shake; mix diluted solution by gentle inversion.
Danish: Arzerra 100 mg koncentrat til infusionsvæske Dosis på 300 mg: Der benyttes 3 hætteglas (15 ml i alt, 5 ml pr. hætteglas): - Udtag og kassér 15 ml fra en pose med 1000 ml 9 mg/ml (0,9 %)
English: Arzerra 1000 mg sterile concentrate ofatumumab
Danish: Arzerra 1000 mg sterilt koncentrat.
English: The diluted solution for infusion must be used within 24 hours of preparation.
Danish: Den fortyndede infusionsvæske skal anvendes inden for 24 timer efter klargøringen.
English: Musculoskeletal and connective tissue disorders General disorders and administration site conditions syndrome*, chills (including rigors)*, hyperhidrosis*
Danish: Cytokinfrigivelses -syndrom*, kuldegysninger kulderystelser)*, hyperhidrose*,
English: Subsequent infusions*
Danish: Rygsmerter*
English: Flush line before and after ofatumumab administration with sodium chloride 9 mg/ml (0.9%) solution for injection to avoid this.
Danish: Skyl slangen med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske før og efter administration af ofatumumab for at undgå, at det blandes med andre lægemidler.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG
English: Cardiac disorders
Danish: Kardiovaskulære tilstande
English: B-cells after the first ofatumumab infusion, leaving a reduced number of CD20
Danish: +-B-celler efter den første infusion af ofatumumab,
English: If you have or have had hepatitis B, tell your doctor before you are given Arzerra.
Danish: Tal med lægen før du får Arzerra, hvis du har eller har haft hepatitis B.
English: 2) How to dilute the solution for infusion
Danish: 2) Fortynding af infusionsvæsken
English: Arzerra 100 mg sterile concentrate ofatumumab
Danish: Arzerra 100 mg sterilt koncentrat.
English: Nervous system disorders Metabolism and nutrition disorders
Danish: Metabolisme og ernæring
English: If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2).
Danish: Hvis der observeres infusionsrelaterede bivirkninger, skal infusionen afbrydes og genstartes, når patientens tilstand er stabil (se afsnit 4.2).
English: The effect of multiple doses of Arzerra on the QTc interval was evaluated in a pooled analysis of three open-label studies in patients with CLL (N=85).
Danish: I en samlet analyse af tre open label-studier med CLL-patienter (n=85) blev indvirkningen af gentagne Arzerra-doser på QTc-intervallet vurderet.
English: If the first infusion was completed without a severe adverse reaction, the remaining infusions of 1000 mg should be administered over 4 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below.
Danish: Hvis den første infusion blev gennemført uden alvorlige bivirkninger, administreres de resterende infusioner på 1000 mg over 4 timer (se punkt 4.2 i produktresuméet) gennem et perifert eller permanent kateter i henhold til nedenstående skema.
English: • rapid heart beat
Danish: • hurtige hjerteslag
English: Each vial contains 100 mg ofatumumab in 5 ml.
Danish: Hvert hætteglas indeholder 100 mg ofatumumab i 5 ml.
English: Arzerra 1000 mg concentrate for solution for infusion
Danish: Arzerra 1000 mg koncentrat til infusionsvæske
English: Arzerra 100 mg concentrate for solution for infusion Arzerra 1000 mg concentrate for solution for infusion ofatumumab
Danish: Arzerra 100 mg koncentrat til infusionsvæske, opløsning Arzerra 1000 mg koncentrat til infusionsvæske, opløsning ofatumumab
English: Sodium acetate (E262)
Danish: Natriumacetat (E262) Natriumchlorid
English: Arzerra concentrate for solution for infusion does not contain a preservative; therefore dilution should be carried out under aseptic conditions.
Danish: Arzerra-koncentratet til infusionsvæske, opløsning, indeholder ingen konserveringsmidler.
English: • Withdraw 50 ml of ofatumumab from the 1000 mg vial and inject into the 1000 ml bag
Danish: • Udtag 50 ml ofatumumab fra 1.000 mg hætteglasset og injicer det i 1000 ml posen.
English: ORR (%) 95% CI P value p<0.001
Danish: 95 % konfidensinterval P-værdi p <0,001
English: Each vial contains 1000 mg of ofatumumab in 50 ml.
Danish: Hvert hætteglas indeholder 1000 mg ofatumumab i 50 ml.