FrancophonIA/ELRC3.0 huggingface dataset:
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Danish: Hazard ratioen kan overføres til en absolut gavnlig effekt udtrykt i en 3-års sygdomsfri estimeret overlevelse på 11,8 procentpoint (87,2 % versus 75,4 %) til fordel for AC→PH (trastuzumab)-armen.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Træk den beregnede volumenmængde af opløsningen ud af hætteglasset og tilsæt den til en infusionspose indeholdende 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: This will then be reduced to a maintenance dose of 2 mg/kg body weight once weekly, beginning one week after the first dose.
Danish: Dette nedsættes derefter til en vedligeholdelsesdosis på 2 mg/kg legemsvægt én gang om ugen med start 1 uge efter den første dosis.
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51-1.79)], non measurable [HR 1.78 (95% CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29-4.97)].
Danish: En eksploratorisk subgruppeanalyse udført i ToGA (BO18255) studiet viste, at der ikke var tydelig fordel for den samlede overlevelse ved at tilføje trastuzumab hos patienter med ECOG PS 2 ved baseline [hazard ratio 0,96 (95 % konfidensinterval: 0,51-1,79)], med ikke målbar sygdom [hazard ratio 1,78 (95 % konfidensinterval: 0,87-3,66)] eller lokalt fremskreden sygdom [hazard ratio 1,20 (95 % konfidensinterval: 0,29-4,97)].
English: The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Danish: Resultatet af den opdaterede analyse af sygdomsfri overlevelse (stratificeret hazard ratio = 0,61; 95 % konfidensinterval [0,54-0,69]) viste lignende gavnlig effekt med hensyn til sygdomsfri overlevelse sammenlignet med den endelige primære analyse af sygdomsfri overlevelse på trods af, at 24,8 % af patienterne i AC→P armen skiftede til at få trastuzumab.
English: 1Swelling face
Danish: 1Opsvulmet ansigt
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease-free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
Danish: Efter en median opfølgning på 12 måneder var hazard ratio for sygdomsfri overlevelse 0,54 (95 % konfidensinterval: 0,44-0,67), hvilket overføres til en absolut gavnlig effekt udtrykt i en 2-års sygdomsfri overlevelsesrate på 7,6 procentpoint (85,8 % versus 78,2 %) til fordel for trastuzumab-armen.
English: The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Danish: Volumen af det centrale kompartment var 2,62 l hos patienter med metastatisk brystkræft og tidlig brystkræft og 3,63 l hos patienter med fremskreden ventrikelkræft.
English: At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Danish: Den sygdomsfrie overlevelsesrate blev efter 8 år estimeret til at være 77,2 % (95 % konfidensinterval: 75,4-79,1) i AC→PH armen, en absolut gavnlig effekt på 11,8 % sammenlignet med AC→P armen.
English: • abnormally low levels of fluid around baby in womb
Danish: • unormalt lidt fostervand omkring barnet i livmoderen
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a fatal infusion reaction.
Danish: Patienter, som oplever hviledyspnø på grund af komplikationer fra avanceret malignitet og co-morbiditet, har muligvis forhøjet risiko for letale infusionsreaktioner.
English: • redness, swelling or sores in your mouth and/or throat
Danish: • rødme, hævelse eller sår i munden og/eller halsen
English: • inability to sleep (insomnia)
Danish: • rygsmerter søvnighed (døsighed)
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when trastuzumab was administered concurrently with taxanes than when administered sequentially to taxanes.
Danish: Hos patienter med tidlig brystkræft er der blevet observeret øget hyppighed af symptomatiske og asymptomatiske kardielle hændelser, når trastuzumab blev administreret efter antracyklin-baseret kemoterapi sammenlignet med administration af et ikke-antracyklin-baseret regime med docetaxel og carboplatin.
English: Overall survival, median months Progression-free survival, Median months
Danish: Progressionsfri overlevelse median måneder Tid til sygdomsprogression, median måneder Samlet responsrate, %
English: • based on a loading dose of 8 mg trastuzumab/kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/kg body weight:
Danish: • baseret på en støddosis på 8 mg trastuzumab/kg legemsvægt eller en efterfølgende 3-ugers dosis på 6 mg trastuzumab/kg legemsvægt:
English: Patients with MBC or MGC should be treated with KANJINTI until progression of disease.
Danish: Patienter med metastatisk brystkræft eller metastatisk ventrikelkræft bør behandles med KANJINTI, indtil sygdommen progredierer.
English: KANJINTI should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Danish: KANJINTI bør kun bruges til patienter med metastatisk ventrikelkræft, som har tumorer med overekspression af HER2 defineret ved IHC 2+ og et bekræftende SISH- eller FISH-resultat, alternativt ved et IHC 3+ resultat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/18/1281/001
English: +Respiratory failure
Danish: +Respirationsinsufficiens
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hætteglasset indeholder 420 mg trastuzumab.
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 150 mg trastuzumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hætteglasset indeholder 150 mg trastuzumab.
English: In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Danish: Desuden er der rapporteret om tilfælde af interstitiel lungesygdom inklusive lungeinfiltrater, akut respiratorisk distress syndrom, pneumoni, pleuraeffusion, åndedrætsbesvær, akut lungeødem og respirationsinsufficiens.
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Danish: For det primære endepunkt, sygdomsfri overlevelse, resulterede tilføjelse af trastuzumab til paclitaxel-kemoterapi i en 52 % nedsættelse af risikoen for sygdomstilbagefald.
English: Median Survival (months) (95%CI)
Danish: Median overlevelse (måneder) (95 % CI)
English: Detection of HER2 over expression or HER2 gene amplification in gastric cancer Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Danish: Detektion af HER2-overekspression eller amplifikation af HER2-genet i ventrikelkræft Kun en præcist og valideret analysemetode bør bruges til at bestemme HER2-overekspression eller HER2-genamplifikation.
English: • abnormal development of the kidneys of the baby in the womb
Danish: • unormal udvikling af fostrets nyrer i livmoderen
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/18/1281/002
English: Distant recurrence No. patients with event
Danish: Distant tilbagefald Antal patienter med en hændelse
English: Detection of HER2 overexpression or HER2 gene amplification in breast cancer KANJINTI should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Danish: Detektion af HER2-overekspression eller amplifikation af HER2-genet i brystkræft KANJINTI bør kun anvendes til patienter med tumorer, som har overekspression af HER2 eller amplifikation af HER2-genet, som bestemt ved en præcis og valideret analyse.
English: Regimen
Danish: Administration
English: Hypoprothrombinaemia
Danish: Hypoprotrombinæmi
English: +Anaphylactic reaction
Danish: +Anafylaktisk reaktion
English: Early breast cancer (adjuvant setting)
Danish: Tidlig brystkræft (adjuverende behandling)
English: Circulating shed HER2-ECD
Danish: Cirkulerende shed HER2 ekstracellulære domæne
English: The reconstituted KANJINTI solution contains 21 mg/mL of trastuzumab.
Danish: Det rekonstituerede KANJINTI-koncentrat indeholder 21 mg/ml trastuzumab.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Træk den beregnede volumenmængde af opløsningen ud af hætteglasset og tilsæt den til en polyvinylchlorid-, polyethylen- eller polypropylen-infusionspose indeholdende 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Danish: 4.4), skal rådes til ikke at køre bil og betjene maskiner, før symptomerne er aftaget.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION KANJINTI 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas indeholder 150 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, produceret af cellekultursuspension fra pattedyr (ovarie fra kinesisk hamster) og oprenset ved affinitets- og ionbytningskromatografi herunder specifikke virale inaktiverings- og oprensningsprocedurer.
English: Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Danish: Studie MO16982: støddosis 6 mg/kg ugentlig x 3 efterfulgt af 6 mg/kg med 3-ugers intervaller 3.
English: KANJINTI and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
Danish: KANJINTI og antracykliner bør ikke anvendes i kombination hos patienter, som får adjuverende behandling.
English: Median duration of response (months) (range) Median TTP (months) (95%CI)
Danish: Median responsvarighed (måneder) (interval) Median TTP (måneder) (95 % CI)
English: • high potassium levels
Danish: • høje kaliumkoncentrationer
English: 2+ A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Danish: 2+ En svag til moderat fuldstændig membranfarvning detekteres i > 10 % af tumorcellerne.
English: Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Danish: Aseptisk teknik skal observeres, da lægemidlet ikke indeholder antimikrobielt konserveringsmiddel eller bakteriostatiske midler.
English: Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8).
Danish: Patienterne bør observeres for symptomer som feber og kulderystelser eller andre infusionsrelaterede symptomer i mindst 6 timer efter påbegyndelse af den første infusion og i 2 timer efter påbegyndelse af efterfølgende infusioner (se pkt.
English: Each 150 mg vial of KANJINTI is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Danish: Indeholdet af hvert 150 mg KANJINTI hætteglas rekonstitueres med 7,2 ml vand til injektionsvæsker (følger ikke med).
English: What KANJINTI is and what it is used for What you need to know before you are given KANJINTI How KANJINTI is given
Danish: Virkning og anvendelse Det skal du vide, før du får KANJINTI Sådan får du KANJINTI Bivirkninger
English: Table 12 Efficacy results from MO16432
Danish: Effektresultater fra MO16432 Parameter
English: • swelling of the lining of the heart
Danish: • hævelse af hinden omkring hjertet
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Danish: Stærk komplet, basolateral eller lateral membranøs reaktivitet i ≥ 10 % af tumorcellerne
English: Early breast cancer (neoadjuvant-adjuvant setting)
Danish: Tidlig brystkræft (neoadjuverende-adjuverende behandling)
English: 3+ Strong complete membrane staining is detected in > 10% of the tumour cells.
Danish: 3+ Stærk, fuldstændig membranfarvning detekteres i > 10 % af tumorcellerne.
English: This will then be reduced to a maintenance dose of 6 mg/kg body weight every three weeks, beginning three weeks after your first dose.
Danish: Dette nedsættes derefter til en vedligeholdelsesdosis på 6 mg/kg legemsvægt hver tredje uge med start 3 uger efter den første dosis.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Danish: Spørg din læge, hvornår du kan få den næste dosis, hvis du har glemt en aftale.
English: +Respiratory distress
Danish: +Åndedrætsbesvær
English: Each 420mg vial of KANJINTI is reconstituted with 20 mL of sterile water for injections (not supplied).
Danish: Indeholdet af hvert 420 mg KANJINTI hætteglas rekonstitueres med 20 ml vand til injektionsvæsker (følger ikke med).
English: KANJINTI 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Danish: KANJINTI 420 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas indeholder 420 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, produceret af cellekultursuspension fra pattedyr (ovarie fra kinesisk hamster) og oprenset ved affinitets- og ionbytningskromatografi herunder specifikke virale inaktiverings- og oprensningsprocedurer.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter):
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Danish: Ved sammenligning af simulerede trastuzumab-serumkoncentrationer efter trastuzumab-monoterapi (4 mg/kg støddosis/2 mg/kg intravenøst ugentlig) og observerede serumkoncentrationer hos japanske kvinder med HER2-positiv metastatisk brystkræft (studie JP16003) blev der ikke fundet evidens for, at samtidig administration af docetaxel påvirkede trastuzumabs farmakokinetik.
English: • abnormal or impaired blood clotting
Danish: • unormal eller dårligere blodstørkning
English: Breast cancer and gastric cancer
Danish: Brystkræft og ventrikelkræft
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas
English: KANJINTI should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Danish: KANJINTI bør kun bruges til patienter med metastatisk eller tidlig brystkræft, som enten har tumorer med overekspression af HER2 eller amplifikation af HER2-genet, bestemt ved en præcis og valideret analyse (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET TIL HÆTTEGLAS
English: Distant recurrence No. patients with event p = 0.0008
Danish: Distant tilbagefald - Antal patienter med en hændelse p = 0,0008
English: HR (95% CI)
Danish: (95 % CI)
English: Regimen Primary tumour type
Danish: Doserings-regime Primær tumor type
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Danish: HER2-positiv metastatisk brystkræft blev behandlet samtidigt med trastuzumab, paclitaxel og doxorubicin, med trastuzumabs farmakokinetiske data i studier, hvor trastuzumab blev administreret som monoterapi (H0649g) eller i kombination med antracykliner plus cyclophosphamid eller paclitaxel (studie H0648g), tydede på, at doxorubicin og paclitaxel ikke påvirker trastuzumabs farmakokinetik.
English: - intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for
Danish: - intravenøs cyclophosphamid på 600 mg/m2 over 30 minutter, administreret hver 3. uge i 4 serier.
English: Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
Danish: Efter markedsføringen er der rapporteret om alvorlige pulmonale bivirkninger ved anvendelse af trastuzumab (se pkt.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in table 8:
Danish: De endelige resultater for samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne er opsummeret i tabel 8 nedenfor:
English: If you miss a dose of KANJINTI
Danish: Hvis du har glemt at få KANJINTI
English: The recommended initial loading dose of KANJINTI is 4 mg/kg body weight.
Danish: Den anbefalede initiale støddosis af KANJINTI er 4 mg/kg legemsvægt.
English: Median duration of follow-up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Danish: Median opfølgningstid var 1,8 år i AC→P-armen og 2,0 år i AC→PH-armen ** Den mediane varighed af længerevarende opfølgning i den samlede analyse af de kliniske studier var 8,3 år (interval: 0,1-12,1) i AC→PH-armen og 7,9 år (interval: 0,0-12,2) i AC→P-armen.
English: What KANJINTI looks like and contents of the pack KANJINTI is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab.
Danish: KANJINTI er et pulver til koncentrat til infusionsvæske, opløsning, som bliver leveret i et hætteglas med en gummiprop, og indeholder enten 150 mg eller 420 mg trastuzumab.
English: • The other ingredient(s) are histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Danish: • Øvrige indholdsstoffer: histidin, histidin monohydrochlorid, trehalosedihydrat og polysorbat 20.
English: • abnormal heart rhythm
Danish: • abnorm hjerterytme
English: LIST OF EXCIPIENTS Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Danish: LISTE OVER HJÆLPESTOFFER Histidin, histidin monohydrochlorid, trehalosedihydrat, polysorbat 20.
English: Table 5 Efficacy results from the non-comparative monotherapy and combination therapy studies
Danish: Effektresultater fra ikke-komparative studier med monoterapi og kombinationsterapi
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Danish: Disse inkluderer, men er ikke begrænset til, lungeinfiltrater, akut respiratorisk distress syndrom, pneumoni, pneumonitis, pleuraeffusion, åndedrætsbesvær, akut lungeødem og respirationsinsufficiens (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning
English: Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831* and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Danish: Resultater for post-hoc eksplorativ analyse fra den samlede analyse fra de kliniske studier NSABP B-31/NCCTG N9831* og BCIRG006, hvor sygdomsfri overlevelse og symptomatiske kardielle bivirkninger blev kombineret
English: Death (OS event) No. patients with event p = 0.0182
Danish: Død (OS hændelse) - Antal patienter med en hændelse p = 0,0182
English: Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, The Netherlands
Danish: Minervum 7061, NL-4817 ZK Breda, Holland
English: As a three-weekly regimen the recommended initial loading dose of KANJINTI is 8 mg/kg body weight.
Danish: I et 3 ugers doseringsregime er den anbefalede initiale støddosis af KANJINTI 8 mg/kg legemsvægt.
English: 4 adverse reaction in the 2-year treatment arm (20.4%) compared with the 1-year treatment arm
Danish: Flere patienter oplevede mindst en grad 3 eller 4 bivirkning i 2-års-behandlings-armen (20,4 %) sammenlignet med 1-års-behandlings-armen (16,3 %).
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Danish: Effektresultaterne fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne efter den endelige analyse af sygdomsfri overlevelse* er sammenfattet i tabel 7.
English: KANJINTI 150 mg powder for concentrate for solution for infusion 20 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 150 mg of trastuzumab.
Danish: KANJINTI 150 mg pulver til koncentrat til infusionsvæske, opløsning 20 ml klart type I hætteglas med butylgummiprop lamineret med en fluor-resin film og aluminiumsforsegling med flip-off hætte som indeholder 150 mg trastuzumab.
English: Median TTP (months) (95%CI) Median Survival (months) (95%CI)
Danish: Median responsvarighed (måneder) (95 % CI) Median TTP (måneder) (95 % CI) Median overlevelse (måneder) (95 % CI)
English: 420 mg vial
Danish: 420 mg hætteglas + 20 ml
English: • based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of
Danish: • baseret på en støddosis på 4 mg trastuzumab/kg legemsvægt eller en efterfølgende ugentlig dosis på 2 mg trastuzumab/kg legemsvægt:
English: Infusion-related reactions (IRRs) and hypersensitivity
Danish: Infusionsrelaterede reaktioner og overfølsomhed