FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis ved 3-ugers intervaller er 6 mg/kg legemsvæ gt og påbegyndes 3 uger efter støddosis.
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Danish: 3+ Stærk komplet, basolateral eller lateral membranøs reaktivitet i ≥10 % af tumorcellerne
English: Tlf: + 47 40 00 42 10
Danish: Orion Pharma AS Tlf: + 47 40 00 42 10
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 begræ nset til, lungeinfiltrater, akut respiratorisk distress syndrom, pneumoni, pneumonitis, pleuraeffusion, åndedræ tsbesvæ r, akut lungeødem og respirationsinsufficiens (se pkt.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger på Det Europæ iske Læ gemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Death (OS event) No. patients with event p=0.0182
Danish: Død (OS hæ ndelse) - Antal patienter med en hæ ndelse p = 0,0182
English: Cmin (μg/mL)
Danish: Cmin (mikrogram/ml)
English: Three-weekly dosing in metastatic breast cancer
Danish: 3-ugers doseringsregime ved metastatisk brystkræ ft
English: 1) Using a sterile syringe, slowly inject 7.2 mL of water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt 7,2 ml vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Herzuma, idet strålen rettes mod det frysetørrede kompakte pulver.
English: Serious IRRs to Herzuma infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Danish: Alvorlige infusionsrelaterede reaktioner, som er rapporteret efter infusion med Herzuma, omfatter dyspnø, hypotension, hvæ sende vejrtræ kning, hypertension, bronkospasmer, supraventrikulæ r takyarytmi, nedsat iltmæ tning, anafylaksi, åndedræ tsbesvæ r, urticaria og angioødem (se pkt.
English: - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle)
Danish: - intravenøs docetaxel - 75 mg/m2 som intravenøs-infusion over 1 time, administreret hver 3. uge i 6 serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier)
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØ RINGSTILLADELSEN
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 legemsvæ gt eller en efterfølgende 3-ugers dosis på 6 mg trastuzumab/kg legemsvæ gt:
English: Distant recurrence No. patients with event p=0.0008
Danish: Distant tilbagefald - Antal patienter med en hæ ndelse p = 0,0008
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution.
Danish: Træ k den beregnede volumenmæ ngde af opløsningen ud af hæ tteglasset og tilsæ t den til en infusionspose indeholdende 250 ml 0,9 % natriumchloridopløsning.
English: Herzuma 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: Herzuma bør kun bruges til patienter med metastatisk eller tidlig brystkræ ft, som enten har tumorer med overekspression af HER2 eller amplifikation af HER2-genet, bestemt ved en præ cis og valideret analyse (se pkt.
English: The recommended maintenance dose of Herzuma at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
Danish: Den anbefalede vedligeholdelsesdosis af Herzuma ved 3-ugers intervaller er 6 mg/kg legemsvæ gt og den påbegyndes 3 uger efter støddosis.
English:  Keep this leaflet.
Danish: Se i pkt.
English: Herzuma should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Danish: Herzuma bør kun anvendes til patienter med tumorer, som har overekspression af HER2 eller amplifikation af HER2-genet, som bestemt ved en præ cis og valideret analyse.
English: 1) Using a sterile syringe, slowly inject 20 mL of water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt 20 ml vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Herzuma, idet strålen rettes mod det frysetørrede kompakte pulver.
English: Oxygen saturation decreased
Danish: Nedsat iltmæ tning
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Danish: Der blev observeret sammenlignelige baseline niveauer af shed HER2 ekstracellulæ re domæ ne i patienter med metastatisk ventrikelkræ ft og patienter med henholdsvis metastatisk brystkræ ft og tidlig brystkræ ft. Der blev ikke observeret tydelig indvirkning på trastuzumab clearance.
English: Hazard ratio versus AC→P (95% CI)
Danish: Hazard ratio versus AC→P (95 % konfidensinterval) p-væ rdi
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Når læ gemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: Event-free survival
Danish: Hæ ndelsesfri overlevelse
English:  Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for trastuzumab, murine proteiner eller over for et eller flere af hjæ lpestofferne anført i pkt.
English: A faint/barely perceptible membrane staining is detected in > 10% of the tumour cells.
Danish: Svag/lige akkurat synlig membranfarvning detekteres i >10 % af tumorcellerne.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØ RINGSTILLADELSESNUMMER (-NUMRE)
English: No staining is observed or membrane staining is observed in < 10% of the tumour cells.
Danish: Der ses ingen farvning eller membranfarvning ses i <10 % af tumorcellerne.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette læ gemiddel findes på Det Europæ iske Læ gemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Febril neutropenia
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Tabel 16: Populationsforudsagte farmakokinetiske parameter væ rdier ved steady state for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræ ft, tidlig brystkræ ft og fremskreden ventrikelkræ ft.
English: • The other ingredients are L-histidine hydrochloride, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Danish: • Ø vrige indholdsstoffer: L-histidinhydrochlorid, L-histidin, ,-trehalosedihydrat og polysorbat
English: Table 4 Efficacy results from the monotherapy and combination therapy studies
Danish: Virkningsresultater fra studier med monoterapi og kombinationsterapi
English: Disease-free survival No. patients with event p=0.0003
Danish: Sygdomsfri overlevelse - Antal patienter med en hæ ndelse p = 0,0003
English: Distant recurrence No. patients with event p<0.0001
Danish: Distant tilbagefald - Antal patienter med en hæ ndelse p <0,0001
English: Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Danish: Oversigt over virkningsanalyserne af AC→D versus DCarbH fra BCIRG 006-studiet
English: Determine the volume of the solution required:  based on a loading dose of 4 mg trastuzumab/kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/kg body weight:
Danish: • baseret på en støddosis på 4 mg trastuzumab/kg legemsvæ gt eller en efterfølgende ugentlig dosis på 2 mg trastuzumab/kg legemsvæ gt:
English: Metastatic breast cancer
Danish: Metastatisk brystkræ ft
English: • liver damage/failure
Danish: • leverskade/leversvigt
English: Death (OS event) No. patients with event p=0.0024
Danish: Død (OS hæ ndelse) - Antal patienter med en hæ ndelse p = 0,0024
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Danish: Kardiel dysfunktion, infusionsrelaterede reaktioner, hæ matotoksicitet (specielt neutropeni), infektioner og pulmonale bivirkninger er til dato blandt de mest alvorlige og/eller almindelige bivirkninger rapporteret ved anvendelse af trastuzumab (intravenøs og subkutan formulering).
English: Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Danish: De populations-forudsagte farmakokinetiske eksponeringsvæ rdier (median med 5-95 percentiler) og farmakokinetiske parameter-væ rdier ved klinisk relevante koncentrationer (Cmax og Cmin) hos patienter med metastatisk brystkræ ft, tidlig brystkræ ft og fremskreden ventrikelkræ ft behandlet med de godkendte ugentlige og 3-ugers doseringsregimer er vist nedenfor i tabel 14 (serie 1), tabel 15 (steady-state) og tabel 16 (farmakokinetiske parametre)
English: Herzuma 150 mg powder for concentrate for solution for infusion Herzuma 420 mg powder for concentrate for solution for infusion
Danish: Herzuma 150 mg pulver til koncentrat til infusionsvæ ske, opløsning Herzuma 420 mg pulver til koncentrat til infusionsvæ ske, opløsning
English: For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Danish: Opbevaringsforhold efter rekonstitution af læ gemidlet, se pkt.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Danish: 2+ En svag til moderat komplet, basolateral eller lateral membranøs reaktivitet i ≥10 % af tumorcellerne
English: Ear and labyrinth disorders Deafness
Danish: Ø re og labyrint
English: What you need to know before you use Herzuma 3.
Danish: Det skal du vide, før du begynder at bruge Herzuma Sådan skal du bruge Herzuma Bivirkninger
English: Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.
Danish: Bivirkninger, som er blevet rapporteret i forbindelse med anvendelse af intravenøst trastuzumab alene eller i kombination med kemoterapi i pivotale kliniske studier og efter markedsføringen, er præ senteret i tabel 1.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette læ gemiddel på Det Europæ iske Læ gemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Danish: Studie WO16229: støddosis 8 mg/kg efterfulgt af 6 mg/kg med 3-ugers intervaller Studie MO16982: støddosis 6 mg/kg ugentlig x 3 efterfulgt af 6 mg/kg med 3-ugers intervaller Studie BO15935
English: Grounds for the variation to the terms of the marketing authorisation(s)
Danish: Begrundelser for æ ndring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Accurate and validated assay methods should be used (see sections 4.4 and 5.1).
Danish: Præ cise og validerede analysemetoder bør anvendes (se pkt.
English: B. PACKAGE LEAFLET
Danish: B. INDLÆ GSSEDDEL
English: AUCss, 0-21days (μg.day/mL)
Danish: AUCss 0-21 dage (mikrogram.
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH
Danish: Oversigt over virkningsanalyserne af AC→D versus AC→DH fra BCIRG 006-studiet
English: The dose of Herzuma depends on your body weight.
Danish: Herzuma-dosis afhæ nger af din legemsvæ gt.
English: N=105
Danish: Trastuzumab1 N = 105
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Danish: Primæ r virkningsanalyse Sygdomsfri overlevelse hazard ratio 95 % konfidensinterval p-væ rdi p <0,0001
English: Biopsy specimen - staining pattern
Danish: Biopsi prøvefarvningsmønstre
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Danish: Udvaskningsperioden for trastuzumab blev vurderet efter ugentlige og 3-ugers intravenøse doseringsregimer ved hjæ lp af den populationsfarmakokinetiske model.
English: Median duration of response (months) (95% CI)
Danish: Responsrate (95 % konfidensinterval) Median responsvarighed (måneder) (interval) Median TTP (måneder) (95 % konfidensinterval)
English: Disease-free survival No. patients with event p<0.0001
Danish: Sygdomsfri overlevelse - Antal patienter med en hæ ndelse p <0,0001
English: Palmar-plantar erythrodysaesthesia syndrome
Danish: Palmoplantar erytrodysæstesi-syndrom Meget almindelig Acne
English: Single doses of Herzuma alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Danish: I et klinisk studie med patienter der havde metastatisk ventrikelkræ ft blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
English: Pulmonary events
Danish: Pulmonale bivirkninger
English: Rare side effects (may affect up to 1 in 1000 people):
Danish: Sjæ ldne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Erytem
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Danish: Resultatet er en 21 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,0.
English: NAME OF THE MEDICINAL PRODUCT
Danish: LÆ GEMIDLETS NAVN
English: Interruption or slowing the rate of the infusion may help control such symptoms.
Danish: Disse symptomer kan muligvis kontrolleres ved afbrydelse af infusionen eller ved at nedsæ tte infusionshastigheden.
English: Each vial of Herzuma is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Danish: Indholdet af hvert Herzuma hæ tteglas rekonstitueres med 7,2 ml sterilt vand til injektionsvæ sker (følger ikke med).
English: AGC
Danish: Batch
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR Æ NDRING AF TEKSTEN
English: Each vial of Herzuma is reconstituted with 20 mL of sterile water for injection (not supplied).
Danish: Indholdet af hvert Herzuma hæ tteglas rekonstitueres med 20 ml sterilt vand til injektionsvæ sker (følger ikke med).
English: In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as statistically significant covariates affecting the exposure of trastuzumab.
Danish: Volumen af det centrale kompartment var 2,62 l hos patienter med metastatisk brystkræ ft og tidlig brystkræ ft og 3,63 l hos patienter med fremskreden ventrikelkræ ft. I den endelige populationsfarmakokinetiske model blev udover primæ r tumortype, kropsvæ gt, serum-aspartat-aminotransferase og -albumin identificeret som statistisk signifikante kovarianter med indvirkning på trastuzumabs eksponering.
English: Each vial of Herzuma is reconstituted with 7.2 mL of water for injections (not supplied).
Danish: Indeholdet af hvert Herzuma hæ tteglas rekonstitueres med 7,2 ml vand til injektionsvæ sker (følger ikke med).
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med stæ rk komplet, basolateral eller lateral membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: 6.3 Shelf life
Danish: 6.1 Hjæ lpestoffer
English: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer
Danish: Anbefalet scoringssystem til evaluering af de IHC-farvede mønstre ved ventrikelkræ ft
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆ NSNINGER VEDRØ RENDE UDLEVERING OG ANVENDELSE
English: Infections and infestations Infection
Danish: Infektioner og parasitæ re sygdomme
English: Chest pain
Danish: Sjæ lden
English: Median TTP (months) (95% CI)
Danish: konfidensinterval) Median TTP (måneder)
English: Strong complete membrane staining is detected in > 10% of the tumour cells.
Danish: Stæ rk, fuldstæ ndig membranfarvning detekteres i >10 % af tumorcellerne.
English: Each vial of Herzuma is reconstituted with 20 mL of water for injections (not supplied).
Danish: Indeholdet af hvert Herzuma hæ tteglas rekonstitueres med 20 ml vand til injektionsvæ sker (følger ikke med).
English: DO NOT SHAKE!
Danish: HÆ TTEGLASSET MÅ IKKE OMRYSTES!
English: Herzuma and anthracyclines should not be given concurrently in combination in the MBC setting.
Danish: Herzuma og antracykliner bør ikke anvendes i kombination hos patienter med metastatisk brystkræ ft.
English: Common Supraventricular tachyarrhythmia Common Cardiomyopathy
Danish: Supraventrikulæ r takyarytmi
English: Median duration of response (months) (range)
Danish: Responsrate konfidensinterval) Median responsvarighed (måneder)
English: analysis DFS hazard ratios (95% CI) p-value p<0.0001
Danish: Virkningsanalyse af læ ngerevarende opfølgning ** Sygdomsfri overlevelse hazard ratio 95 % konfidensinterval p-væ rdi p <0,0001
English: Herzuma 150 mg powder for concentrate for solution for infusion trastuzumab
Danish: Herzuma 150 mg pulver til koncentrat til infusionsvæ ske, opløsning trastuzumab
English: Herzuma 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: Herzuma 420 mg pulver til koncentrat til infusionsvæ ske, opløsning trastuzumab
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Danish: SÆ RLIG ADVARSEL OM, AT LÆ GEMIDLET SKAL OPBEVARES UTILGÆ NGELIGT FOR BØ RN
English:  If you have any further questions, ask your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Danish: Reaktionerne inkluderer, kulderystelser, feber, dyspnø, hypotension, hvæ sende vejrtræ kning, bronkospasmer, takykardi, nedsat iltmæ tning, åndedræ tsbesvæ r, udslæ t, kvalme, opkastning og hovedpine (se pkt.
English: Hyperkalaemia
Danish: Hyperkaliæ mi
English: Time to steadystate
Danish: Paræ stesi
English: Herzuma 420 mg powder for concentrate for solution for infusion
Danish: Herzuma 420 mg pulver til koncentrat til infusionsvæ ske, opløsning
English: • throat infections
Danish: • lungeinfektion
English: Herzuma 150 mg powder for concentrate for solution for infusion
Danish: Herzuma 150 mg pulver til koncentrat til infusionsvæ ske, opløsning
English: Death (OS event): No. patients with event p=0.014
Danish: Død (OS hæ ndelse) - Antal patienter med en hæ ndelse p = 0,014**
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevar læ gemidlet utilgæ ngeligt for børn.
English: Vascular disorders
Danish: Ekstremiteterssmerter
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
Danish: Den mediane opfølgningstid var 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH-armen.
English: Recurrence-free survival - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Danish: Tilbagefaldsfri overlevelse - Antal patienter med en hæ ndelse - Antal patienter uden en hæ ndelse p-væ rdi versus observation Hazard ratio versus observation
English: Overall survival (death) - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Danish: Samlet overlevelse (død) - Antal patienter med en hæ ndelse - Antal patienter uden en hæ ndelse p-væ rdi versus observation Hazard ratio versus observation
English: Tel: + 372 6 644 550
Danish: Orion Pharma Eesti OÜ Tel: + 372 6 644 550
English:  additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) The efficacy results from Study MO16432 are summarised in Table 12.
Danish: Virkningsresultaterne i studie MO16432 er sammenfattet i tabel 12.
English: Pleural effusion
Danish: Trastuzumab udvaskning
English: Distant disease-free survival - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Danish: Distant sygdomsfri overlevelse - Antal patienter med en hæ ndelse - Antal patienter uden en hæ ndelse p-væ rdi versus observation Hazard ratio versus observation
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Læ gemidlet må kun udleveres efter ordination på en recept udstedt af en begræ nset læ gegruppe (se bilag I: Produktresumé, pkt.
English: These may be moderate to severe and have been associated with death (see section 4.8).
Danish: Disse bivirkninger kan væ re moderate til alvorlige og har væ ret dødelige i visse tilfæ lde (se pkt.
English: Disease-free survival - No. patients with event - No. patients without event P-value versus observation Hazard ratio versus observation
Danish: Sygdomsfri overlevelse - Antal patienter med en hæ ndelse - Antal patienter uden en hæ ndelse p-væ rdi versus observation Hazard ratio versus observation
English: VIAL LABEL
Danish: Ø get tåreflåd
English: Median follow-up 12 months*
Danish: konfidensinterval) Median overlevelse (måneder)
English: Retinal haemorrhage
Danish: Metastatisk ventrikelkræ ft
English: Ataxia
Danish: Døsighed
English: This means that 3 options are possible:
Danish: Der er således tre valgmuligheder:
English: Also, as already stated earlier, the US population is not considered representative of the EU population.
Danish: Som nævnt anses populationen i USA desuden ikke for at være repræsentativ for populationen i EU.
English: Overall summary of the scientific evaluation of Yvidually and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Yvidually og tilknyttede navne (se bilag I)
English: Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency
Danish: Videnskabelige konklusioner og begrundelser for positiv udtalelse fremsat af Det Europæiske Lægemiddelagentur
English: • Interim analysis of the European study 14701
Danish: • Interimanalyse af den europæiske undersøgelse 14701
English: Only very limited data from the interim analysis are currently available.
Danish: På nuværende tidspunkt foreligger der kun meget begrænsede data fra interimanalyserne.
English: Mandatory phase (Day 1 to day 24):
Danish: Obligatorisk fase (dag 1 til dag 24):
English: The dose recommendation consists of two phases:
Danish: Dosisanbefalingen omfatter to faser: