natgillin/translations-raw huggingface dataset:
Trastuzumab er blevet undersøgt i kombination med anastrozol ved 1. linjebehandling af metastatisk brystkræ ft hos HER2-positive, hormon-receptor-positive (dvs. østrogen-receptor og/eller progesteronreceptor) postmenopausale patienter.
Trastuzumab has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor [ER] and/or progesterone-receptor [PR]) positive postmenopausal patients.
AUC0-21 dage (mikrogram.dag/ml)
AUC0-21days (μg.day/mL)
Hvis patienten har vedvarende nedsat venstre ventrikelfunktion, men forbliver asymptomatisk, bør læ gen overveje at seponere Herzuma, hvis der ikke ses nogen klinisk fordel.
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of Herzuma therapy has been seen.
- Studie BO16348 var designet til at sammenligne 1 og 2-års trastuzumab-behandling hver 3. uge versus observation hos patienter med HER2-positiv tidlig brystkræ ft efter operation, standard-kemoterapi og strålebehandling (hvis indiceret).
- Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
For at sikre validering af testmetoderne og produktion af præ cise og reproducerbare resultater skal HER2-testning udføres i et laboratorium med træ net personale.
To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
SÆ RLIGE OPBEVARINGSBETINGELSER
SPECIAL STORAGE CONDITIONS
Kun en præ cist og valideret analysemetode bør bruges til at bestemme HER2-overekspression eller HER2-genamplifikation.
Only an accurate and validated assay should be used to detect HER2 over expression or HER2 gene amplification.
Den testmetode for overekspression af HER2, som blev brugt til at bestemme patienternes egnethed i det pivotale studie med trastuzumab-monoterapi og i de kliniske studier med trastuzumab plus paclitaxel, anvendte immunhistokemisk farvning for HER2 af fikseret materiale fra brysttumorer ved hjæ lp af de murine monoklonale antistoffer CB11 og 4D5.
The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Der foreligger ingen tilgæ ngelige data fra kliniske studier for genbehandling hos patienter, der tidligere har fået adjuverende behandling med Herzuma.
Currently no data from clinical trials are available on re-treatment of patients with previous exposure to Herzuma in the adjuvant setting.
Der var en sammenhæ ng mellem niveauerne af shed-antigen og serum-aspartataminotransferase; en del af shed-antigenets indvirkning på clearance kan muligvis forklares ud fra serum-aspartat-aminotransferase niveauet.
There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels.
I det neoadjuverende-adjuverende studie af tidlig brystkræ ft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøst trastuzumab antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
For den samlede overlevelse var hazard ratio 0,75 (95 % konfidensinterval 0,51 - 1,11) i IHC2+/FISH+ gruppen og 0,58 (95 % konfidensinterval 0,41 - 0,81) i ICH3+/FISH+ gruppen.
For overall survival, the HR was 0.75 (95% CI 0.51 - 1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41 - 0.81) in the IHC 3+/FISH+ group.
Herzuma indeholder:
What Herzuma contains
• du har haft hjertesvigt, koronararteriesygdom, hjerteklapsygdom (hjertemislyd) eller forhøjet blodtryk, eller hvis du tager eller har taget medicin mod forhøjet blodtryk.
 you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
Herzuma-dosis blev ikke reduceret i de kliniske studier.
No reductions in the dose of Herzuma were made during clinical trials.
Der var ingen tidsmæ ssige restriktioner for administrationen af trastuzumab og anastrozol (se dosis i produktresuméet for anastrazol eller andre aromatasehæ mmere).
There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Pulmonal fibrose
+Pulmonary fibrosis
DATO FOR FØ RSTE MARKEDSFØ RINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Når infusionsvæ sken først er fremstillet skal den anvendes med det samme.
Once the infusion is prepared it should be administered immediately.
Ingen reaktivitet eller membranøs reaktivitet i <10 % af tumorcellerne
No reactivity or membranous reactivity in < 10% of tumour cells
Virkningsresultaterne fra ikke-komparative monoterapi og kombinationsterapi studier er sammenfattet i tabel 5:
The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Infusionen kan fortsæ ttes, når symptomerne er blevet formindsket.
The infusion may be continued after the symptoms improve.
I studie BO16348 var incidensen af svæ r kongestiv hjerteinsufficiens (NYHA-klasse III & IV) efter 1 års trastuzumab-behandling 0,8 % efter en median opfølgning på 8 år, og hyppigheden af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel var 4,6 %.
In Study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
I 3 pivotale kliniske studier, hvor adjuverende trastuzumab blev administreret i kombination med kemoterapi, var hyppigheden af kardiel dysfunktion af grad 3/4 (isæ r symptomatisk kongestiv hjerteinsufficiens) tilsvarende hos patienter, der fik administreret kemoterapi alene (dvs. som ikke fik trastuzumab), som hos patienter, der fik trastuzumab sekventielt efter ettil taxan (0,3 - 0,4 %).
In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3 - 0.4%).
- capecitabin - 1.000 mg/m oralt 2 gange dagligt i 14 dage hver 3. uge i 6 serier (aften på dag 1 til morgen på dag 15 i hver serie)
- capecitabine - 1000 mg/m orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var tidlig brystkræ ft begræ nset til kvinder med operabel brystkræ ft med høj risiko, defineret som HER2-positiv og med positive lymfeknuder i aksillen eller HER2-positiv og med negative lymfeknuder i aksillen med høje risikofaktorer (tumorstørrelse >1 cm og ER-negativ eller tumorstørrelse >2 cm, uanset hormonstatus).
In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumour size > 1 cm and ER negative or tumour size > 2 cm, regardless of hormonal status).
Der foreligger ingen data om immunogenicitet for trastuzumab ved ventrikelkræ ft.
There are no immunogenicity data available for trastuzumab in gastric cancer.
For at forebygge fejlmedicinering er det vigtigt at kontrollere hæ tteglassets etiket for at sikre, at det læ gemiddel, der klargøres og administreres, er Herzuma (trastuzumab) og ikke Kadcyla (trastuzumabemtansin).
In order to prevent medication errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Herzuma (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Behandling med AC→PH resulterede i en statistisk signifikant forbedring af samlet overlevelse sammenlignet med AC→P (stratificeret hazard ratio = 0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-væ rdi <0,0001).
Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Et volumenoverskud på 4 % sikrer, at den angivne dosis på 420 mg kan træ kkes op af hvert hæ tteglas.
A volume overage of 4% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Ét tilfæ lde af tumorlyse syndrom med trastuzumab som monoterapi behandling støtter dette yderligere.
One case of tumour lysis syndrome with trastuzumab administration as monotherapy lends further support.
Det skal du vide, før du begynder at bruge Herzuma
What you need to know before you use Herzuma
INDHOLD ANGIVET SOM VÆ GT, VOLUMEN ELLER ANTAL DOSER
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1Forhøjet blodtryk
Blood pressure increased
Læ ger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.
Healthcare professionals are asked to report any suspected adverse reactions.
- cisplatin - 80 mg/m hver 3. uge i 6 serier på dag 1 i hver serie.
- cisplatin - 80 mg/m every 3 weeks for 6 cycles on day 1 of each cycle.
I BCIRG 006-studiet blev trastuzumab administreret enten i kombination med docetaxel efter AC-kemoterapi (AC→DH) eller i kombination med docetaxel og carboplatin (DCarbH).
In the BCIRG 006 study, trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
Egentlige farmakokinetiske studier hos æ ldre og hos personer med nedsat nyre- eller leverfunktion er ikke udført.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Danmark Orion Pharma A/S
Norge Orion Pharma AS
Hos patienter med tidlig brystkræ ft bør de kardiologiske vurderinger, som er udført ved baseline, gentages hver 3. måned under behandlingen og hver 6. måned efter behandlingsophør indtil 24 måneder efter sidste administration af Herzuma.
For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Herzuma.
Patienter med tidlig brystkræ ft bør behandles med Herzuma i 1 år, eller indtil sygdommen recidiverer afhæ ngigt af, hvad der forekommer først; forlæ ngelse af behandling af tidlig brystkræ ft udover et år anbefales ikke (se pkt.
Patients with EBC should be treated with Herzuma for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
I BCIRG 006-studiet var HER2-positiv tidlig brystkræ ft defineret som brystkræ ft hos enten patienter med positive lymfeknuder eller hos højrisiko-patienter med negative lymfeknuder, hvor ingen (pN0) lymfeknude var involveret og mindst 1 af følgende faktorer: tumorstørrelse større end 2 cm, østrogenreceptor- og progesteronreceptor-negative, histologisk og/eller kernegrad 2 - 3 eller alder <35 år.
In the BCIRG 006 study, HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2 - 3, or age < 35 years.
Volumen (ml) = Legemsvæ gt (kg) x dosis (8 mg/kg som støddosis eller 6 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Hvert hætteglas indeholder 150 mg trastuzumab, som skal opløses i 7,2 ml vand til injektionsvæ sker.
Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Patienter, som tidligere har fået antracyklinbaseret adjuverende kemoterapi, blev behandlet med paclitaxel (175 mg/m infunderet over
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m infused over 3 hours) with or without trastuzumab.
Den på forhånd planlagte endelige analyse af samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne blev udført, da 707 dødsfald var forekommet (median opfølgningstid var 8,3 år i AC→PH-gruppen).
The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→PH
Antracyklin-baseret behandling bør så vidt muligt undgås i op til 7 måneder efter ophør af Herzuma-behandlingen.
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herzuma.
- intravenøs cyclophosphamid på 600 mg/m over 30 minutter, administreret hver 3. uge i
- intravenous cyclophosphamide, at 600 mg/m over 30 minutes, given every 3 weeks for
Tidlig brystkræ ft (adjuverende behandling)
Early breast cancer (adjuvant setting)
Kemo alene (n = 116)
Chemo only (n=116)
De ikke-lineæ re eliminations-parametre var 8,81 mg/dag for den maksimale eliminationshastighed (Vmax) og 8,92 mikrogram/ml for Michaelis-Menten kontanten (Km) hos patienter med metastatisk brystkræ ft, tidlig brystkræ ft eller fremskreden ventrikelkræ ft.
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC and AGC patients.
Hvis patienten undlader en dosis af Herzuma i en uge eller mindre, bør den sæ dvanlige vedligeholdelsesdosis (ugentligt doseringsregime: 2 mg/kg; 3-ugers doseringsregime: 6 mg/kg) administreres så hurtigt som muligt.
If the patient has missed a dose of Herzuma by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible.
Volumen (ml) = Legemsvæ gt (kg) x dosis (4 mg/kg som støddosis eller 2 mg/kg til vedligeholdelse) 21 (mg/ml, koncentration af rekonstitueret opløsning)
Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
150 mg Uåbnet hæ tteglas
150 mg Unopened vial
Se produktresuméet for paclitaxel, docetaxel eller aromatasehæ mmer for information om reduktion af dosis eller udsæ ttelse af behandlingen.
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Tabel 15: Populationsforudsagte steady-state farmakokinetiske eksponeringsvæ rdier (med
Table 15 Population predicted steady state PK exposure values (median with 5
L-histidinhydrochlorid L-histidin -trehalosedihydrat polysorbat 20
L-histidine hydrochloride L-histidine α,α-trehalose dihydrate Polysorbate 20
p-væ rdi versus AC→P
p-value versus AC→P
Patienterne er valgbare for behandling med Herzuma, hvis de udviser stæ rk overekspression af HER2, som beskrevet med en 3+ score ved IHC eller et positivt FISH eller CISH resultat.
Patients are eligible for Herzuma treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Brug ikke Herzuma hvis du bemæ rker nogle partikler eller misfarvning inden brug.
Do not use Herzuma if you notice any particulate matter or discoloration prior to administration.
Ved neoadjuverende behandling er erfaringen med samtidig administration af trastuzumab og et lavdosis antracyklin-regime begræ nset (se pkt.
In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
Herzuma er et biosimilæ rt læ gemiddel.
Herzuma is a biosimilar medicinal product.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØ RINGSTILLADELSEN
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Sygdomsfri overlevelse - Antal patienter med en hæ ndelse (%)
Disease-free survival No. patients with event (%)
Responsvarighed Median måneder
Duration of response, median months
420 mg Uåbnet hæ tteglas
420 mg Unopened vial
Parenterale læ gemidler skal inspiceres visuelt for partikler og misfarvning inden administration.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Symptomatisk hjerteinsufficiens opstået under behandling med Herzuma bør behandles med standardbehandling af kongestiv hjerteinsufficiens.
If symptomatic cardiac failure develops during Herzuma therapy, it should be treated with standard medicinal products for CHF.
Tidlig brystkræ ft i HERA-studiet var begræ nset til operabel, primæ r, invasiv adenokarcinom i brystet med positive lymfeknuder i aksillen, eller med negative lymfeknuder i aksillen, hvis tumoren var mindst 1 cm i diameter.
Early breast cancer in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
Herzuma er indiceret til behandling af voksne patienter med HER2-positiv tidlig brystkræ ft:
Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
Efter rekonstitution indeholder 1 ml koncentrat 21 mg trastuzumab.
After reconstitution, 1 mL concentrate contains 21 mg of trastuzumab.
Død (OS-hæ ndelse): Antal patienter med en hæ ndelse (%)
Death (OS event): No. patients with event (%)
På trods af overkrydsning til trastuzumab i kontrolarmen resulterede tilføjelse af trastuzumab til paclitaxel-kemoterapi i en 52 % nedsæ ttelse af risikoen for sygdomstilbagefald.
Despite the crossover to trastuzumab in the control arm, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
1+ En svag/lige akkurat synlig membranøs reaktivitet i ≥10 % af tumorcellerne; cellerne er kun reaktive i dele af deres membran
Faint ⁄ barely perceptible membranous reactivity in ≥ 10% of tumour cells; cells are reactive only in part of their membrane
EVENTUELLE SÆ RLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆ GEMIDDEL SAMT AFFALD HERAF
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
I de pivotale studier (H0648g, M77001) blev paclitaxel eller docetaxel administreret dagen efter den første trastuzumab-dosis (se dosis i produktresuméet for paclitaxel eller docetaxel).
In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Metabolisme og ernæring Vægttab
Metabolism and nutrition disorders
Hvis patienten undlader en dosis af Herzuma i mere end en uge, bør der administreres en ny støddosis af Herzuma over ca. 90 minutter (ugentligt doseringsregime: 4 mg/kg; 3-ugers doseringsregime:
If the patient has missed a dose of Herzuma by more than one week, a re-loading dose of Herzuma should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
• du er allergisk over for trastuzumab, murine proteiner (fra mus) eller et af de øvrige indholdsstoffer i Herzuma (angivet i punkt 6).
Do not take Herzuma if:  you are allergic to trastuzumab, to murine (mouse) proteins or any of the other ingredients of this medicine (listed in section 6).
Bivirkninger rapporteret med intravenøs trastuzumab-monoterapi eller i kombination med kemoterapi i pivotale kliniske studier (N = 8.386) samt efter markedsføring.
Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing
Median opfølgning 12 måneder* Median opfølgning 8 år**
Median follow-up 8 years**
I det pivotale studie, MO16432 blev trastuzumab administreret samtidig med neoadjuverende kemoterapi, som indeholdt 3 serier af doxorubicin (kumulativ dosis 180 mg/m
In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m
Hvis LVEF ikke er forbedret eller er faldet yderligere, eller hvis der er udviklet symptomatisk kongestiv hjerteinsufficiens, bør det kraftigt overvejes at afbryde Herzuma-behandlingen, medmindre fordelene for den enkelte patient anses at opveje risiciene.
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herzuma should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Trastuzumab er blevet anvendt i kliniske studier som monoterapi til patienter med metastatisk brystkræ ft, som har tumorer, som viser overekspression af HER2, og hvis metastatiske sygdom ikke har responderet på et eller flere kemoterapiregimer (trastuzumab alene).
Trastuzumab has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (trastuzumab alone).
Trastuzumabs farmakokinetik blev evalueret i en populationsfarmakokinetisk model-analyse ved brug af puljede data fra 1.582 forsøgspersoner, som fik trastuzumab intravenøst, inkluderende patienter med HER2-positiv metastatisk brystkræ ft, tidlig brystkræ ft, fremskreden ventrikelkræ ft eller andre tumortyper, og raske forsøgspersoner, i 18 fase I-, II- og III-studier.
The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab intravenous.
Primæ r tumor type
Primary tumour type
De gavnlige effekter, baseret på det kliniske studies resultater, var begræ nset til patienter med de højeste niveauer af overekspression af HER2-proteinet, defineret ved et 3+ score ved IHC eller 2+ score ved IHC og et positivt FISH- resultat.
Based on the clinical trial results, the beneficial effects were limited to patients with the highest level of HER2 protein overexpression, defined by a 3+ score by IHC, or a 2+ score by IHC and a positive FISH result.
BETINGELSER ELLER BEGRÆ NSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆ GEMIDLET
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Trastuzumab er et rekombinant humant IgG1 monoklonalt antistof mod den humane epidermale væ kstfaktorreceptor 2 (HER2).
Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2).
Herzuma er indiceret til behandling af voksne patienter med HER2-positiv metastatisk brystkræ ft:
Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):