FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) are: - constipation, indigestion, - headache, - tiredness, - loss of appetite, - hiccups, - increased amount of liver enzymes in your blood.
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 personer): - Forstoppelse, fordøjelsesbesvær - Hovedpine - Træthed - Appetitløshed - Hikke - Forhøjet indhold af leverenzymer i blodet.
English: After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
Danish: Efter rekonstitution og fortynding indeholder 1 ml opløsning 1 mg fosaprepitant (1 mg/ml) (se pkt.
English: Table 4: Alternative dosing for the prevention of nausea and vomiting associated with single day regimens of HEC or MEC in paediatric patients
Danish: Tabel 4: Alternativ dosering til forebyggelse af kvalme og opkastning i forbindelse med 1dages regimer med HEC eller MEC hos pædiatriske patienter
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with oral ondansetron 8 mg for 2 doses and oral dexamethasone 12 mg. On Days 2 and 3, patients in the fosaprepitant group received placebo for ondansetron every 12 hours.
Danish: Fosaprepitantregimet bestod af fosaprepitant 150 mg på dag 1 i kombination med oral ondansetron 8 mg i 2 doser og oral dexamethason 12 mg. På dag 2 og 3 fik patienterne i fosaprepitantgruppen placebo for ondansetron hver 12. time.
English: Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the use of fosaprepitant.
Danish: Der bør anvendes alternative supplerende ikke-hormonelle præventionsmetoder under behandling med fosaprepitant og i 2 måneder efter sidste fosaprepitantdosis.
English: Talk to your doctor, pharmacist, or nurse before using IVEMEND.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger IVEMEND.
English: Dosing for Single or Multi-Day Chemotherapy Regimens For paediatric patients receiving single or multi-day regimens of HEC or MEC, administer IVEMEND as an intravenous infusion through a central venous catheter on Days 1, 2, and 3.
Danish: Dosering for 1-dages eller flere dages behandling med kemoterapiregimer Til pædiatriske patienter, der får 1-dages eller flere dages behandling med kemoterapiregimer af HEC eller MEC, administreres IVEMEND som en intravenøs infusion via et centralt venekateter på dag 1, 2 og 3.
English: Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Danish: Fosaprepitant er et aprepitant-prodrug, og omdannes hurtigt efter intravenøs indgift til aprepitant (se pkt.
English: Lactose anhydrous
Danish: Lactose, vandfrit
English: Table 3: Recommended dosing for the prevention of nausea and vomiting associated with single or multi-day regimens of HEC or MEC in paediatric patients
Danish: Tabel 3: Anbefalet dosering til forebyggelse af kvalme og opkastning i forbindelse med 1-dages eller flere dages regimer med HEC eller MEC hos pædiatriske patienter
English: For fosaprepitant and aprepitant no clinical data on exposed pregnancies are available.
Danish: Der findes ingen kliniske data for gravide kvinder eksponeret for fosaprepitant og aprepitant.
English: Mild hepatic impairment (Child-Pugh class A) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Danish: Let nedsat leverfunktion (Child-Pugh klasse A) har ingen klinisk relevant indflydelse på aprepitants farmakokinetik, og dosisjustering er derfor ikke nødvendig hos patienter med let nedsat leverfunktion.
English: 6 months<2 years old
Danish: 6 måneder< 2 år
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant.
Danish: Hvert hætteglas indeholder fosaprepitant dimeglumin svarende til 150 mg fosaprepitant.
English: The frequency categories in the table are based on studies in adults; the observed frequencies in the paediatric studies were similar or lower.
Danish: Frekvenserne, som blev observeret i de pædiatriske studier, var sammenlignelige eller lavere.
English: The efficacy of a 1-day fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day adult fosaprepitant regimen.
Danish: Virkningen af et 1-dages fosaprepitantregime hos pædiatriske patienter forventes at være sammenlignelig med virkningen af det 1-dages fosaprepitantregime hos voksne.
English: See the product information for the selected 5-HT3 antagonist for appropriate dosing information none none none
Danish: Se produktinformationen for de valgte 5-HT3-antagonister for information om hensigtsmæssig dosering ingen ingen ingen
English: Chemotherapeutic medicinal products
Danish: Kemoterapeutika
English: Immune system disorders hypersensitivity reactions including anaphylactic reactions not known
Danish: Overfølsomhedsreaktioner inklusive anafylaktiske reaktioner
English: Table 2: Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy regimen in adults
Danish: Tabel 2: Anbefalet dosering til forebyggelse af kvalme og opkastning i forbindelse med moderat emetogen kemoterapiregime hos voksne
English: Skin and subcutaneous tissue disorders rash, acne uncommon photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, rash pruritic, Stevens-Johnson syndrome/toxic epidermal necrolysis rare pruritus, urticaria not known
Danish: Fotosensibilitet, hyperhidrose, seborré, hudlæsioner, kløende udslæt, StevensJohnsons syndrom/toksisk epidermal nekrolyse
English: Aprepitant regimen (N =1,134) **
Danish: (N= 1.134)**
English: ‡ Delayed phase = 25 to 120 hours post-initiation of chemotherapy.
Danish: ‡ Forsinket fase = 25 til 120 timer efter initiering af kemoterapi.
English: Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant, which corresponds to 130.5 mg of aprepitant.
Danish: Hvert hætteglas indeholder fosaprepitant dimeglumin svarende til 150 mg fosaprepitant, som svarer til 130,5 mg aprepitant.
English: - If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Each vial contains 150 mg of fosaprepitant.
Danish: Et hætteglas indeholder 150 mg fosaprepitant.
English: IVEMEND 150 mg powder for solution for infusion.
Danish: IVEMEND 150 mg pulver til infusionsvæske, opløsning.
English: See the product information for the selected 5-HT3 antagonist for appropriate dosing information.
Danish: Se produktinformationen for den valgte 5-HT3-antagonist for information om hensigtsmæssig dosering.
English: Table 1: Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimen in adults
Danish: Tabel 1: Anbefalet dosering til forebyggelse af kvalme og opkastning i forbindelse med højemetogen kemoterapiregime hos voksne
English: Use of oral aprepitant not required Read the package leaflet before use.
Danish: Brug af oral aprepitant er ikke påkrævet.
English: Fosaprepitant 150 mg is a weak CYP3A4 inhibitor as a single dose on Day 1 with no evidence of inhibition or induction of CYP3A4 observed on Day 4.
Danish: Som enkelt dosis på dag 1 er fosaprepitant 150 mg en svag CYP3A4-hæmmer, og der blev ikke observeret tegn på hæmning eller induktion af CYP3A4 på dag 4.
English: ALT increased common
Danish: Øget ALAT
English: Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of fosaprepitant.
Danish: Øjeblikkelige overfølsomhedsreaktioner inklusive flushing, erytem, dyspnø, anafylaksi/anafylaktisk shock
English: Skin and subcutaneous tissue disorders erythema uncommon
Danish: Hud og subkutane væv
English: Investigations blood pressure increased uncommon
Danish: Forhøjet blodtryk
English: Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare
Danish: Bradykardi, kardiovaskulær sygdom
English: 12 - 17 years old 150 mg 30400
Danish: 150 mg 30.400 3.500 735
English: 5 mg/kg intravenously
Danish: 5 mg/kg intravenøst
English: 3 mg/kg intravenously
Danish: 3 mg/kg intravenøst
English: §Overall = 0 to 120 hours post-initiation of chemotherapy.
Danish: § Totalt = 0 til 120 timer efter initiering af kemoterapi.
English: The aprepitant regimen consisted of aprepitant 125 mg on Day 1 and 80 mg/day on Days 2 and 3 in combination with ondansetron 32 mg IV on Day 1 and dexamethasone 12 mg on Day 1 and 8 mg daily on Days 2 through 4.
Danish: 80 mg/dag på dag 2 og 3 i kombination med ondansetron 32 mg IV på dag 1 og dexamethason 12 mg på dag 1 og 8 mg dagligt på dag 2-4.
English: powder for solution for infusion 1 vial
Danish: Pulver til infusionsvæske, opløsning 1 hætteglas
English: Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the use of fosaprepitant (see section 4.5).
Danish: Alternativ supplerende ikke-hormonel præventionsmetode bør anvendes under behandling med fosaprepitant og i 2 måneder efter sidste fosaprepitantdosis (se pkt.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12.
Danish: Farmakoterapeutisk klassifikation: Antiemetika og kvalmestillende lægemidler.
English: Maximum dose 150mg
Danish: Maksimal dosis 150 mg
English: AST increased, blood alkaline phosphatase increased uncommon red blood cells urine positive, blood sodium decreased, weight decreased, neutrophil count decreased, glucose urine present, urine output increased rare
Danish: Positiv test for røde blodceller i urinen, hyponatriæmi, vægttab, fald i neutrofiltal, glukosuri, øget urinudskillelse
English: See selected 5-HT3 antagonist prescribing information for the recommended dosage
Danish: Se produktinformationen for den valgte 5-HT3antagonist for oplysninger om den anbefalede dosering
English: 4 mg/kg intravenously
Danish: 4 mg/kg intravenøst
English: §§Acute= 0 to 24 hours post-initiation of chemotherapy.
Danish: §§ Akut= 0 til 24 timer efter initiering af kemoterapi.
English: What IVEMEND contains - The active substance is fosaprepitant.
Danish: • Aktivt stof: Fosaprepitant.
English: Avoid shaking and jetting sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.
Danish: Undgå at ryste hætteglasset og at sprøjte natriumchloridopløsningen 9 mg/ml (0,9%) ind i en hård stråle.
English: VIAL LABEL 150 mg
Danish: ETIKET PÅ HÆTTEGLAS 150 mg
English: uncommon
Danish: Ikke almindelig
English: Fosaprepitant regimen (N =1,106) **
Danish: (N= 1.106) **
English: Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with IVEMEND.
Danish: - Prævention, som kan omfatte p-piller, præventions-plastre, implantater og visse præventionsmidler, som placeres i livmoderen, og som frigør hormoner, vil måske ikke være effektiv, når den bruges sammen med IVEMEND.
English: 1-day IV dose
Danish: 1-dages i.v.
English: Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare
Danish: Muskelsvaghed, muskelkramper
English: Refer to the Summary of Product Characteristics of co-administered 5-HT3 antagonist medicinal products.
Danish: Der henvises til produktresuméet for samtidigt administrerede 5-HT3-antagonister.
English: The control regimen consisted of fosaprepitant placebo 150 mg IV on Day 1 in combination with oral ondansetron 8 mg for 2 doses and oral dexamethasone 20 mg. On Days 2 and 3, patients in the control group received 8 mg oral ondansetron every 12 hours.
Danish: på dag 1 i kombination med oral ondansetron 8 mg i 2 doser og oral dexamethason 20 mg. På dag 2 og 3 fik patienterne i kontrolgruppen 8 mg oral ondansetron hver 12. time.
English: Gastrointestinal disorders constipation, dyspepsia common eructation, nausea*, vomiting*, gastroesophageal reflux disease, abdominal pain, dry mouth, flatulence uncommon duodenal ulcer perforation, stomatitis, abdominal distension, faeces hard, neutropenic colitis rare
Danish: Opstød, kvalme*, opkastning*, gastroøsofageal refluks, abdominalsmerter, mundtørhed, flatulens
English: §Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy.
Danish: Totalt = 0-120 timer efter initiering af kemoterapi med cisplatin.
English: §§Delayed phase = 25 to 120 hours post-initiation of cisplatin chemotherapy.
Danish: Forsinket fase = 25-120 timer efter initiering af kemoterapi med cisplatin.
English: Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant and for 2 months following the last dose of fosaprepitant (see sections 4.4 and 4.5).
Danish: Alternative supplerende ikke-hormonelle kontraceptionsmetoder bør anvendes under behandling med fosaprepitant eller oral aprepitant og i 2 måneder efter sidste aprepitant-dosis (se pkt.
English: Nervous system disorders headache common dizziness, somnolence uncommon cognitive disorder, lethargy, dysgeusia rare
Danish: Kognitiv forstyrrelse, letargi, dysgeusi
English: Check with your doctor or pharmacist if you are not sure.
Danish: • Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: There are some medicines that should not be taken with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not use IVEMEND').
Danish: Nogle lægemidler må ikke tages sammen med IVEMEND (såsom pimozid, terfenadin, astemizol og cisaprid).
English: In 3 active-controlled, open-label clinical studies, paediatric patients aged 6 months to 17 years received either highly or moderately emetogenic chemotherapy and a single dose of fosaprepitant at or above the recommended 1-day regimen dose (139 patients) or 3-day regimen (199 patients), in combination with ondansetron with or without dexamethasone.
Danish: I 3 aktivt kontrollerede, åbne kliniske studier fik pædiatriske patienter i alderen 6 måneder til 17 år enten højemetogen eller moderat emetogen kemoterapi og en enkeltdosis fosaprepitant ved eller over
English: Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon
Danish: Febril neutropeni, anæmi
English: It is important to tell your doctor if you are breastfeeding or are planning to breast-feed before receiving this medicine.
Danish: Før du får lægemidlet, er det vigtigt, at fortælle lægen, om du ammer eller planlægger at amme.
English: When using combined IVEMEND and EMEND regimens, please refer to the Summary of Product Characteristics (SmPC) section 4.5 for EMEND capsules or EMEND for oral suspension.
Danish: 4.5 i produktresuméerne for EMEND kapsler eller EMEND pulver til oral suspension ved kombinationsbehandling med IVEMEND- og EMEND-regimer.
English: Uncommon side effects (may affect up to 1 in 100 people) are: - dizziness, sleepiness, - acne, rash, - anxiousness, - burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind, - increased painful or burning urination, - weakness, generally feeling unwell, - reddening of the face/skin, hot flush, - fast or irregular heartbeats, blood pressure increased,
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 1.000 personer): - Svimmelhed, søvnighed - Akne, udslæt - Angst - Opstød, kvalme, opkastning, halsbrand, mavesmerter, mundtørhed, luftafgang fra tarmen, sår i munden
English: In patients with mild to moderate hypertension, infusion of 100 mg of fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1.4-fold increase in diltiazem AUC and a small but clinically meaningful decrease in blood pressure, but did not result in a clinically meaningful change in heart rate, or PR interval.
Danish: Hos patienter med let til moderat hypertension medførte infusion af 100 mg fosaprepitant over 15 minutter sammen med diltiazem 120 mg 3 gange dagligt en øgning af diltiazems AUC på 1,4 gange.
English: Respiratory, thoracic and mediastinal disorders hiccups common oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare
Danish: Orofaryngeal smerte, nysen, hoste, næseflåd, irritation i svælget
English: Psychiatric disorders anxiety uncommon disorientation, euphoric mood rare
Danish: Desorientering, eufori
English: 3-day IV/IV/IV dose
Danish: 3-dages i.v./i.v./i.v.
English: - fever with increased risk of infection, lowering of red blood cells, - infusion site pain, infusion-site redness, infusion-site itching, infusion site vein inflammation.
Danish: - Øget smertefuld og sviende fornemmelse ved vandladning - Svækkelse, generel følelse af utilpashed - Rødmen i ansigtet, hudrødme, hedeture - Hurtig eller uregelmæssig hjerterytme (puls), forhøjet blodtryk - Feber med øget risiko for infektion, fald i antal røde blodlegemer - Smerte, rødme og/eller kløe på infusionsstedet, irritation i åren, hvor infusionen bliver givet.
English: Ear and labyrinth disorders tinnitus rare
Danish: Luftveje, thorax og mediastinum
English: Posology
Danish: Pollakisuri
English: In a randomized, parallel, double-blind, active-controlled study, IVEMEND 150 mg (N=1,147) was compared with a 3-day aprepitant regimen (N=1,175) in adult patients receiving a HEC regimen that included cisplatin (≥70 mg/m2).
Danish: I et randomiseret, parallelt, dobbeltblindet, aktivt kontrolleret studie blev IVEMEND 150 mg (N=1.147) sammenlignet med et 3-dages behandlingsregime med aprepitant (N=1.175) hos voksne patienter, der fik et HEC-behandlingsregime, som inkluderede cisplatin (≥70 mg/m Behandlingsregimet med fosaprepitant bestod af fosaprepitant 150 mg på dag 1 i kombination med ondansetron 32 mg IV på dag 1 og dexamethason 12 mg på dag 1, 8 mg på dag 2 og 8 mg to gange dagligt på dag 3 og 4.
English: Paediatrics
Danish: Polydipsi
English: (See section 4.3).
Danish: 4.4 og 4.5).
English: Tabulated list of adverse reactions - aprepitant
Danish: Bivirkningstabel - aprepitant
English: Hepatic impairment
Danish: Svimmelhed, døsighed
English: - Keep this leaflet.
Danish: • Gem indlægssedlen.
English: What IVEMEND is and what it is used for What you need to know before you use IVEMEND How to use IVEMEND
Danish: Det skal du vide, før du begynder at bruge IVEMEND Sådan skal du bruge IVEMEND Bivirkninger
English: General disorders and administration site conditions infusion site erythema, infusion site pain, infusion site pruritus uncommon infusion site induration rare immediate hypersensitivity reactions including flushing, erythema, dyspnoea, anaphylactic reactions/anaphylactic shock not known
Danish: Under eller lige efter infusion af fosaprepitant har der været umiddelbare overfølsomhedsreaktioner inklusive flushing, erytem, dyspnø og anafylaksi/anafylaktisk shock.
English: Adverse reaction
Danish: Conjunctivitis
English: It is used on its own when other treatments have not worked or are not suitable.
Danish: Det anvendes som enkeltstofbehandling, når andre behandlinger ikke har virket eller ikke er egnede.
English: Further information on Trazimera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Trazimera findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Danish: Hos patienter, der ikke har nogen væsentlige reaktioner på den første 90-minutters infusion, kan de efterfølgende infusioner gives over 30 minutter.
English: An overview of Trazimera and why it is authorised in the EU
Danish: En oversigt over Trazimera, og hvorfor det er godkendt i EU
English: This means that Trazimera is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Trazimera i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: It can also be used earlier in treatment, in combination with chemotherapy.
Danish: Det kan også anvendes tidligere i behandlingen i kombination med kemoterapi.
English: As for all medicines, data on the use of Trazimera are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Trazimera løbende overvåget.
English: The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion.
Danish: Infusionen kan medføre allergiske reaktioner, og derfor skal patienten overvåges under og efter infusionen.
English: The dose depends on the patient's body weight, on the condition being treated and on whether Trazimera is given every week or every 3 weeks.
Danish: Dosen afhænger af patientens legemsvægt, den tilstand, der skal behandles, og om Trazimera gives hver uge eller hver tredje uge.
English: In this study, 63% of patients given Trazimera had a complete or partial response to treatment compared with 67% of those given Herceptin.
Danish: I dette studie opnåede 63 % af de patienter, der fik Trazimera, fuldstændig eller delvis respons på behandlingen sammenholdt med 67 % af dem, der fik Herceptin.
English: Trazimera is a cancer medicine used to treat the following conditions:
Danish: Trazimera er et lægemiddel mod kræft, der anvendes til behandling af følgende tilstande:
English: • metastatic breast cancer (cancer that has spread to other parts of the body).
Danish: • metastatisk brystkræft (brystkræft, der har spredt sig til andre dele af kroppen).
English: What is Trazimera and what is it used for?
Danish: Hvad er Trazimera, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Trazimera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Trazimera?
English: Other information about Trazimera
Danish: Andre oplysninger om Trazimera
English: Side effects reported with Trazimera are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Trazimera vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Trazimera can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Danish: Trazimera udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i brug af kræftlægemidler.
English: For more information about using Trazimera, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Trazimera, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The most common or serious side effects with Trazimera are heart problems, reactions related to the Trazimera infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Danish: De hyppigste eller alvorligste bivirkninger ved Trazimera er hjerteproblemer, reaktioner i forbindelse med Trazimera-infusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
English: Why is Trazimera authorised in the EU?
Danish: Hvorfor blev Trazimera godkendt i EU?
English: Trazimera is a ‘biosimilar medicine'.
Danish: Trazimera er et "biosimilært lægemiddel".
English: In addition, a main study involving 707 patients with metastatic breast cancer that overexpressed HER2 showed that Trazimera was as effective in treating the condition as Herceptin.
Danish: Endvidere viste et hovedstudie med deltagelse af 707 patienter med metastatisk brystkræft og overudtryk af HER2, at Trazimera var lige så effektivt til at behandle sygdommen som Herceptin.
English: The reference medicine for Trazimera is Herceptin.
Danish: Referencelægemidlet for Trazimera er Herceptin.
English: Because Trazimera is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Trazimera.
Danish: Da Trazimera er et biosimilært lægemiddel, behøver de studier af trastuzumabs virkning og sikkerhed, der er udført for Herceptin, ikke at blive gentaget for Trazimera.