FrancophonIA/ELRC3.0 huggingface dataset:
English: 2-hour period under close clinical monitoring, including pulse, blood pressure, and temperature.
Danish: Den rekonstituerede og fortyndede opløsning skal indgives intravenøst ved infusion over en 2-timers periode under tæt klinisk overvågning, herunder puls, blodtryk og temperatur.
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to inhibit the activities of CYP1A2, CYP2A6 (tested only using gemtuzumab ozogamicin), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 at clinically relevant concentrations.
Danish: In vitro viste N-acetyl-gamma-calicheamicin dimethylhydrazid og gemtuzumab ozogamicin et lavt potentiale for at hæmme aktiviteten af CYP1A2, CYP2A6 (udelukkende testet med gemtuzumab ozogamicin), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/5 ved klinisk relevante koncentrationer.
English: Effects on female reproductive organs and the eye in monkeys were adverse in the 12-week study (approximately 193 and 322 times, respectively, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Danish: Der sås skadelige virkninger på hunlige reproduktionsorganer og øjne hos aber i 12-ugers studiet (henholdsvis ca. 193 og 322 gange human klinisk eksponering efter tredje humane dosis på 3 mg/m2 baseret på
English: e. Leukopenia includes the following reported PTs: Leukopenia and White blood cell count decreased.
Danish: Leukopeni omfatter følgende indberettede FT'er: Leukopeni og nedsat antal hvide blodlegemer.
English: d. 2-sided p-value from the log-rank test. e. Response defined as CR+CRp.
Danish: Respons defineret som CR+CRp.
English: Table 9.
Danish: Skema 9.
English: (13.0%), Upper respiratory tract infection (4.3%), Bacterial infection (3.6%), Viral infection (24.2%), Gastrointestinal infection (3.3%), Skin infection (7.9%), and Other infections (19.5%).
Danish: Infektion omfatter sepsis og bakteriæmi (25,6 %), svampeinfektion (10,5 %), nedre luftvejsinfektion (13 %), øvre luftvejsinfektion (4,3%), bakterieinfektion (3,6 %), virusinfektion (24,2%), gastrointestinal infektion (3,3 %), hudinfektion (7,9 %) og andre infektioner (19,5 %).
English: MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin
Danish: MYLOTARG 5 mg pulver til koncentrat til infusionsvæske, opløsning gemtuzumab ozogamicin
English: Male reproductive effects (testes, epididymides, seminal vesicles) in monkeys were observed at approximately 66 times the human clinical exposure after the third dose of 3 mg/m2).
Danish: Der blev fundet påvirkning af hanlige reproduktionsorganer (testikler, bitestikler, sædblærer) hos aber ved ca. 66 gange den humane kliniske eksponering efter den tredje humane dosis på 3 mg/m
English: When reconstituted to a 1 mg/mL concentration as directed, the extractable content of the vial is 4.5 mg (4.5 mL).
Danish: Efter rekonstitution til en koncentration på 1 mg/ml, som beskrevet, er det muligt at udtage 4,5 mg (4,5 ml).
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7
Danish: 3 mg/m2/dosis (op til højst et hætteglas af 5 mg) på dag 1, 4, og 7
English: Men must use 2 methods of effective contraception during treatment and for at least 4 months after the last dose of treatment.
Danish: Kvinder skal bruge 2 sikre præventionsmidler under behandlingen og i mindst 7 måneder efter sidste dosis.
English: In clinical studies infusion related reactions, including anaphylaxis were reported (see section 4.8).
Danish: Infusionsrelaterede reaktioner (herunder anafylaksi) Der er blevet indberettet infusionsrelaterede reaktioner i kliniske studier, herunder anafylaksi (se pkt.
English: Effects on the reproductive tract of female monkeys were observed in the 12-week study (atrophy of the ovary, oviduct, uterus, and cervix; approximately 193 times the human clinical exposure after the third dose of 3 mg/m2).
Danish: Der er observeret virkning på reproduktionsorganer hos hunaber i 12-ugers studiet (ovarie-, salpinx-, uterus- og cervixatrofi, ved ca. 193 gange den humane kliniske eksponering efter den tredje humane dosis på 3 mg/m
English: • If the reconstituted solution cannot be used immediately, it may be stored in the original vial for up to 6 hours in a refrigerator (2°C-8°C) with not more than 3 hours at room temperature (below 25°C).
Danish: • Hvis den rekonstituerede opløsning ikke kan anvendes med det samme, kan den opbevares i det oprindelige hætteglas i op til 6 timer i køleskab (2 °C - 8 °C) og ikke over 3 timer ved stuetemperatur (under 25 °C).
English: Infection*a
Danish: *a
English: • Gently swirl the vial to aid dissolution.
Danish: • Hvirvl glasset forsigtigt for at fremme opløsning.
English: Risk difference [95% CI]f p-valueg
Danish: Risikodifference [95 % CI] p-værdi
English: Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin.
Danish: Hvert hætteglas pulver til koncentrat til infusionsvæske, opløsning indeholder 5 mg gemtuzumab ozogamicin.
English: c. Venoocclusive liver disease includes the following reported PTs: Venoocclusive disease and Venoocclusive liver disease*.
Danish: Veno-okklusiv leversygdom omfatter følgende indberettede FT'er: veno-okklusiv sygdom og veno-okklusiv leversygdom t.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 36.5 and 43 days, respectively.
Danish: Gennemsnitstiden for restitution af trombocyttal til 50.000/mm 3 og 100.000/mm 3 var henholdsvis 36,5 og 43 dage.
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 21 and 25 days, respectively.
Danish: Gennemsnitstiden for bedring af neutrofiltallene til ANC på 500/mm 3 og 1.000/mm 3 var henholdsvis 21 og 25 dage.
English: 5 years
Danish: til dag 5
English: g. Lymphopenia includes the following reported PTs: Lymphopenia and Lymphocyte count decreased.
Danish: Lymfopeni omfatter følgende indberettede FT'er: Lymfopeni og nedsat lymfocyttal.
English: j. Tachycardia includes the following reported PTs: Tachycardia, Sinus tachycardia, Heart rate increased#, and
Danish: Takykardi omfatter følgende indberettede FT'er: Takykardi, sinustakykardi, forhøjet hjertefrekvens# samt supraventrikulær takykardi#.
English: All of these TEAEs were determined to be adverse drug reactions.
Danish: Disse blev faslagt til at være bivirkninger.
English: 1 g/m2/every 12 hours on Day 1 to Day 4
Danish: 1 g/m2/hver 12. time på dag 1 til dag 4
English: Infections and infestations Very common Infection*a
Danish: Infektioner og parasitære sygdomme Meget almindelig Infektion
English: Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and incomplete platelet recovery [CRp]) occurred in 22 (20.4%) of patients.
Danish: 3 45 dage efter starten på behandling af responderende patienter (CR og delvis hæmatologisk restitution (CRp)), forekom hos 22 (20,4 %) af patienterne.
English: The safety and efficacy of MYLOTARG in paediatric patients with relapsed or refractory AML has not been established (see sections 4.1 and 4.2).
Danish: MYLOTARGs sikkerhed og virkning hos pædiatriske patienter med recidiverende eller refraktær AML er ikke klarlagt (se pkt.
English: 1 g/m2/every 12 hours on Day 1 to Day 3
Danish: 1 g/m2/hver 12. time på dag 1 til dag 3
English: Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Danish: Vedvarende trombocytopeni (Trombocytter < 100.000/mm
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7 at clinically relevant concentrations.
Danish: In vitro viste N-acetyl-gamma-calicheamicin dimethylhydrazid og gemtuzumab ozogamicin lavt potentiale for at hæmme aktiviteten af UGT1A1, UGT1A4, UGT1A6, UGT1A9 og UGT2B7 ved klinisk relevante koncentrationer.
English: p. Stomatitis includes the following reported PTs: Mucosal inflammation, Oropharyngeal pain, Stomatitis, Mouth ulceration, Oral pain, Oral mucosal blistering, Aphthous stomatitis, Tongue ulceration, Glossodynia, Oral mucosal erythema, Glossitis#, and Oropharyngeal blistering#.
Danish: Stomatitis omfatter følgende FT'er: slimhindeinflammation, orofaryngeale smerter, stomatitis, mundsår, mundsmerter, mundslimhindeblærer, aftøs stomatitis, sår på tungen, glossodyni, erytem på mundslimhinden, tungebetændelse og tungeblærer q.
English: There were no preneoplastic or neoplastic lesions observed in monkeys up to approximately 115 times the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Danish: Der blev ikke observeret præ-neoplastiske eller neoplastiske læsioner hos aber ved op til ca. 115 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m baseret på
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to induce the activities of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
Danish: In vitro havde N-acetyl-gamma-calicheamicin dimethylhydrazid og gemtuzumab ozogamicin lavt potentiale for at fremme CYP1A2-, CYP2B6- og CYP3A4-aktivitet ved klinisk relevante koncentrationer.
English: Hepatobiliary disorders Very common Transaminases increasedq Hyperbilirubinaemiar
Danish: Neutropenisk colitis Lever og galdeveje Meget almindelig Forhøjede transaminaser Hyperbilirubinæmi Almindelig
English: MYLOTARG 5 mg powder for concentrate for solution for infusion
Danish: MYLOTARG 5 mg pulver til koncentrat til infusionsvæske, opløsning
English: Each vial contains 5 mg of gemtuzumab ozogamicin.
Danish: Det indeholder 5 mg gemtuzumab ozogamicin.
English: For patients experiencing a complete remission (CR) following induction, defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count (ANC) of more than 1.0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended.
Danish: 9/l eller mere i perifert blod uden transfusion, anbefales op til to konsolideringsforløb med intravenøs DNR (60 mg/m på én dag (første forløb) eller 2 dage (andet forløb) i kombination med intravenøs AraC (1 g/m 2 pr. 12 timer, indgivet over 2 timer op til maksimaldosen på et hætteglas a 5 mg på dag 1).
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction.
Danish: Andre lægemidlers virkning på gemtuzumab ozogamicin N-acetyl-gamma-calicheamicin dimethylhydrazid metaboliseres in vitro primært via non-enzymatisk reduktion.
English: Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, patients who had received an HSCT prior to gemtuzumab ozogamicin exposure were 2.6 times more likely (95% CI: 1.448, 4.769) to develop VOD compared to patients without HSCT prior to treatment with gemtuzumab ozogamicin; patients who had received an HSCT following treatment with gemtuzumab ozogamicin were 2.9 times more likely (95% CI: 1.502, 5.636) to develop VOD compared to patients without HSCT following treatment with gemtuzumab ozogamicin; and patients who had moderate/severe hepatic impairment at baseline were 8.7 times more likely (95% CI: 1.879, 39.862) to develop VOD compared to patients without moderate/severe hepatic impairment at baseline.
Danish: Baseret på en analyse af potentielle risikofaktorer hos voksne patienter, der fik MYLOTARG som monoterapi, var der hos patienter, som fik en HSCT før eksponering for gemtuzumab ozogamicin, 2,6 gange større sandsynlighed (95 % CI: 1,448-4,769) for at udvikle VOD sammenlignet med patienter, som ikke fik HSCT før gemtuzumab ozogamicin-behandling.
English: Infusion of MYLOTARG should be performed under close clinical monitoring, including pulse, blood pressure, and temperature.
Danish: Infusion med MYLOTARG bør udføres under tæt klinisk overvågning, inkl.
English: • have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots which may include fluid retention, rapid weight gain, increased liver size (which may be painful), and ascites (excessive accumulation of fluid in the abdominal cavity).
Danish: • har eller har haft leverproblemer: MYLOTARG kan under eller efter behandlingen, forårsage en potentiel livstruende tilstand hvor blodårerne i leveren beskadiges og blokeres af blodpropper.
English: During the induction phase, 109 (83.2%) and 99 (75.6%) patients had platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Danish: Under induktionsfasen havde 109 (83,2 %) og 99 (75,6 %) patienter restitution af trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm 3.
English: After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
Danish: Efter rekonstitution indeholder hvert hætteglas 1 mg/ml gemtuzumab ozogamicin.
English: Number of events, n (%) Median RFS in months [95% CI]a
Danish: Antal hændelser, n (%) Median EFS i måneder [95 % CI]
English: Skin and subcutaneous tissue disorders Very common Rashu
Danish: Budd-Chiaris syndrom Hud og subkutane væv Meget almindelig
English: b. Thrombocytopenia includes the following reported PTs: Platelet count decreased and Thrombocytopenia*.
Danish: Trombocytopeni omfatter følgende FT'er: Nedsat antal trombocytter og trombocytopeni*.
English: Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med MYLOTARG Fortæl lægen eller sundhedspersonalet, hvis du tager anden medicin for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Danish: Gennemsnitstiden for bedring af trombocyttallene til 50.000/mm 3 og 100.000/mm 3 var henholdsvis 32 og 35 dage.
English: In patients with hyperleukocytic AML, leukoreduction should be considered with hydroxyurea or leukapheresis to reduce the peripheral WBC count to below 30,000/mm3 prior to administration of MYLOTARG to reduce the risk of inducing TLS (see section 4.2).
Danish: Hos patienter med hyperleukocytisk AML bør leukoreduktion med hydroxyurea eller leukaferese overvejes for at reducere antallet af perifere hvide blodlegemer til under 30.000/mm
English: Febrile neutropenia
Danish: Neutropeni Anæmi Leukopeni
English: Based on population pharmacokinetic (PK) analyses, the combination of gemtuzumab ozogamicin with DNR and AraC is not predicted to cause clinically meaningful changes in the PK of these agents.
Danish: Virkning på co-administrerede kemoterapeutiske midler Baseret på farmakokinetiske (PK) populationsanalyser forventes det ikke, at kombinationen med gemtuzumab ozogamicin og hydroxyurea, DNR og AraC vil forårsage klinisk meningsfulde PKændringer af disse stoffer.
English: If the product cannot be used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2°C-8°C) from the time of initial vial puncture with not more than 6 hours at room temperature (below 25°C).
Danish: Hvis den rekonstituerede opløsning ikke kan anvendes med det samme, kan den opbevares i det oprindelige hætteglas i op til 18 timer i køleskab (2 °C - 8 °C) efter anbrud og ikke over 6 timer ved stuetemperatur (under 25 °C).
English: 35 mg/m2/day on Day 1 to Day 2
Danish: 35 mg/m 2/dag på dag 1 til dag 2
English: In a randomised study (COG AAML0531) that evaluated standard chemotherapy alone or combined with MYLOTARG in 1,063 newly diagnosed children with AML (93.7% of patients < 18 years of age), and young adults (6.3% of patients); mean age was 8.9 years (range: 0-29 years), patients with de novo AML were randomly assigned to either standard 5-course chemotherapy alone or to the same chemotherapy with 2 doses of MYLOTARG (3 mg/m2/dose) administered once in induction Course 1 and once in intensification Course 2.
Danish: I et randomiseret studie (COG AAML0531), der evaluerede standard kemoterapi alene eller kombineret med MYLOTARG hos 1.063 nyligt diagnosticerede børn med AML (93,7 % af patienterne var <18 år) og unge (6,3 % af patienterne), hvor gennemsnitsalderen var 8,9 år (interval: 029 år).
English: During the consolidation 2 phase, 80 (97.6%) and 70 (85.4%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Danish: Under konsolideringsfase 2 havde 80 (97,6 %) og 70 (85,4 %) patienter restitution af trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm 3.
English: Non-fractionatedb MYLO TARG
Danish: Ikke-fraktioneret MYLOTARG
English: Discontinuation of treatment should be strongly considered for patients who develop signs or symptoms of anaphylaxis, including severe respiratory symptoms or clinically significant hypotension (see section 4.2).
Danish: Hvis en patient udvikler symptomer på anafylaksi, herunder alvorlige respiratoriske symptomer, eller klinisk signifikant hypotension, skal seponering af behandlingen alvorligt overvejes (se pkt.
English: During the consolidation 1 phase, 92 (94.8%) and 71 (73.2%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Danish: Under konsolideringsfase 1 havde 92 (94,8 %) og 71 (73,2 %) patienter forbedret trombocyttal til henholdsvis 50.000/mm 3 og 100.000/mm
English: h. Infusion related reaction includes the following reported PTs: Infusion related reaction, Urticaria, Hypersensitivity,
Danish: Infusionsrelateret reaktion omfatter følgende indberettede FT'er: Infusionsrelateret reaktion, urticaria, hypersensitivitet, bronkospasme, overfølsomhed over for lægemidler og urticaria på injektionssted i.
English: • Pain in the abdomen
Danish: • Smerter i mave/underliv
English: y. Fatigue includes the following reported PTs: Fatigue, Asthenia, Lethargy, and Malaise.
Danish: Træthed omfatter følgende indberettede FT'er: udmattelse, slaphed, sløvhed og utilpashed.
English: The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS.
Danish: × 3) til standard induktions-kemoterapi til patienter med tidligere ubehandlet de novo AML resulterede i en statistisk signifikant og klinisk meningsfuld forbedring af EFS.
English: d. Anaemia includes the following reported PTs: Anaemia and Haemoglobin decreased.
Danish: Anæmi omfatter følgende indberettede FT'er: Anæmi og nedsat hæmoglobin.
English: Nausea Stomatitisp
Danish: • Dårlig fordøjelse
English: Hazard ratio [95% CI] c p-valued
Danish: Hazard ratio [95 % CI] p-værdi
English: Hazard ratio [95% CI]c p-valued
Danish: Hazard ratio [95% CI] p-værdi
English: Table 2.
Danish: Skema 2.
English: e: Where analysed, median recovery (defined as 20 x 109/L or 50 x 109/L for platelets and 0.5 x 109/L for neutrophils) ranged from 42-48 days for platelets and 30-37 days for neutrophils.
Danish: 9/l for neutrofile) varierede fra 42 til 48 dage for trombocytter og fra 30 til 37 dage for neutrofile i de tilfælde, hvor den blev analyseret.
English: • Signs of an enlarged liver (hepatomegaly), such as an enlarged belly
Danish: • Symptomer på forstørret lever, som kan være at maven vokser
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with renal impairment.
Danish: Der er ikke udført formelle PK-studier af gemtuzumab ozogamicin hos patienter med nedsat nyrefunktion.
English: Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN and AST and ALT to
Danish: Udsæt MYLOTARG indtil bedring af totalbilirubin er ≤ 2 × ULN, og ASAT og ALAT er ≤ 2,5 × ULN før hver dosis.
English: Cytogenetics (unfavourable), N Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Danish: Cytogenetik (ugunstig), N Antal dødsfald, n (%) Median OS i måneder [95% CI] Hazard ratio [95% CI] p-værdi
English: (5.3%), Bacterial infection (9.2%), Gastrointestinal infection (8.4%), Skin infection (2.3%), and Other infections b. Haemorrhage includes Central nervous system haemorrhage (3.1%), Upper gastrointestinal haemorrhage (33.6%), Lower gastrointestinal haemorrhage (17.6%), Subcutaneous haemorrhage (60.3%), Other haemorrhage (64.9%), and Epistaxis (62.6%).
Danish: Blødning omfatter blødning i centralnervesystemet (3,1 %), øvre gastrointestinal blødning (33,6 %) nedre gastrointestinal blødning (17,6 %), subkutan blødning (60,3 %), anden blødning (64,9 %) og næseblod (62,6 %).
English: In the consolidation 2 phase of therapy, 80 (97.6%) patients had neutrophil recovery to counts of 500/mm3, and 79 (96.3%) patients recovered to counts of 1,000/mm3.
Danish: Under konsolideringsfase 2 af behandlingen havde 80 (97,6 %) patienter forbedret neutrofiltallet til 500/mm 3, og 79 (96,3 %) patienter forbedrede tallet til 1.000/mm Gennemsnitstiden for bedring af neutrofiltallene til ANC på 500/mm 3 og 1.000/mm 3 var henholdsvis
English: Post-marketing (frequency category unknown)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: ELN (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Danish: ELN (god/intermediær), N Antal hændelser, n (%) Median EFS i måneder [95% CI]
English: In subgroup analyses in ALFA-0701, the addition of MYLOTARG to standard combination chemotherapy did not improve EFS in the subgroup of patients having adverse-risk cytogenetics (HR 1.11; 95% CI: 0.63, 1.95).
Danish: Anvendelse ved AML med ugunstige cytogenetiske forandringer I analyse af subgrupper i ALFA-0701 blev EFS ikke forbedret ved tilføjelsen af MYLOTARG til standard kombinationskemoterapi hos patienter, der havde ugunstig risiko-cytogenetik.
English: Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Danish: Forlænget protrombintid Forlænget aktiveret partiel tromboplastin-tid
English: Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Danish: Hætteglasset er ravfarvet type 1-glas med en prop af butylgummi og flip off-hætte med krympeforsegling.
English: Cytogenetics (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Danish: Cytogenetik (god/intermediær), N Antal hændelser, n (%) Median EFS i måneder [95% CI]
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført formelle PK-studier af gemtuzumab ozogamicin hos patienter med nedsat leverfunktion.
English: Cytogenetics (unfavourable), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Danish: Cytogenetik (ugunstig), N Antal hændelser, n (%) Median EFS i måneder [95% CI] Hazard ratio [95% CI] p-værdi
English: Cytogenetics (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Danish: Cytogenetik (god/intermediær), N Antal dødsfald, n (%) Median OS i måneder [95% CI]
English: ELN (poor/adverse), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Danish: ELN (dårlig/ugunstig), N Antal hændelser, n (%) Median EFS i måneder [95% CI] Hazard ratio [95% CI] p-værdi
English: ELN (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Danish: ELN (god/intermediær), N Antal dødsfald, n (%) Median OS i måneder [95% CI]
English: • Mouth inflammation
Danish: • Mundbetændelse
English: 60 mg/m2/day on Day 1 to Day 2
Danish: 60 mg/m 2/dag på dag 1 til dag 2
English: After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Danish: 6.6) indeholder den koncentrerede opløsning 1 mg/ml gemtuzumab ozogamicin.