natgillin/translations-raw huggingface dataset:
Hvert hætteglas indeholder enten: - 150 mg trastuzumab, som skal opløses i 7,2 ml vand til injektionsvæsker, eller - 420 mg trastuzumab, som skal opløses i 20 ml vand til injektionsvæsker.
Each vial contains either: 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection.
Selvom antallet af tilfælde, som opfylder Cairo-Bishop kriterierne og som blev identificeret ved søgning i sikkerhedsdatabesen var lave, så tilsluttes det, at trastuzumab ikke kan udelukkes som bidragende faktor til tumorlyse syndrom.
Although the number of cases identified by a search of the safety database and meeting the CairoBishop criteria for diagnosis was low, it is endorsed that a contributing factor of trastuzumab to tumour lysis syndrome (TLS) could not be excluded.
I den neoadjuverende-adjuverende behandling var studie MO16432, et randomiseret multicenterstudie, designet til at undersøge den kliniske virkning af samtidig administration af trastuzumab og neoadjuverende kemoterapi, herunder både et antracyklin og et taxan, efterfulgt af adjuverende trastuzumab, op til en total behandlingsvarighed på 1 år.
In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to a total treatment duration of 1 year.
Farmakoterapeutisk klassifikation: Antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC03
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 Ontruzant is a biosimilar medicinal product.
Brug ikke Ontruzant, hvis du bemærker partikler eller misfarvning inden brug.
Do not use Ontruzant if you notice any particulate matter or discoloration prior to administration.
I BCIRG 006-studiet blev HER2-positiv EBC defineret som enten lymfeknudepositive eller lymfeknudenegative højrisikopatienter uden (pN0) lymfeknudeinddragelse og mindst 1 af følgende faktorer: tumorstørrelse over 2 cm, østrogenreceptor- og progesteronreceptornegativ, histologisk og/eller nuklear grad 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).
• doxorubicin 60 mg/m2 og paclitaxel 150 mg/m2 administreret hver 3. uge i 3 cyklusser efterfulgt af paclitaxel 175 mg/m2 administreret hver 3. uge i 4 cyklusser,
• Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, which was followed by Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
En HER2-test er obligatorisk før initiering af terapi (se pkt.
HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1).
Ontruzant er et pulver til koncentrat til intravenøs infusionsvæske, opløsning, som bliver leveret i et hætteglas af glas med en gummiprop, der indeholder enten 150 mg eller 420 mg trastuzumab.
Ontruzant 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.
Risikofaktorer i forbindelse med interstitiel lungesygdom omfatter tidligere eller samtidig behandling med andre antineoplastiske terapier, der er kendt for at være forbundet med denne sygdom, såsom taxaner, gemcitabin, vinorelbin og stråleterapi.
Risk factors associated with interstitial lung disease include prior or concomitant therapy with other anti-neoplastic therapies known to be associated with it such as taxanes, gemcitabine, vinorelbine and radiation therapy.
Lineær clearance var 0,136 l/dag ved MBC, 0,112 l/dag ved EBC og 0,176 l/dag ved fremskreden ventrikelkræft.
Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Under en Ontruzant-infusion kan der forekomme kulderystelser, feber og andre influenzalignende symptomer.
During an Ontruzant infusion, chills, fever and other flu like symptoms may occur.
I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var EBC begrænset til kvinder med operabel brystkræft med høj risiko defineret som HER2-positiv og aksillær lymfeknudepositiv eller HER2-positiv og lymfeknudenegativ med højrisikoegenskaber (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).
Disse symptomer er meget almindelige (kan forekomme hos mere end 1 ud af 10 personer).
These are very common (may affect more than 1 in 10 people).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1241/002
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1241/002
efter operation, kemoterapi (neoadjuverende eller adjuverende) og strålebehandling (hvis indiceret) (se pkt.
following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Forekomsten af febril neutropeni, leukopeni, anæmi, trombocytopeni og neutropeni er meget almindelig.
Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly.
• hvis du har haft hjertesvigt, kranspulsåresygdom, hjerteklapsygdom (hjertemislyd), 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.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du får Ontruzant:
Talk to your doctor, pharmacist or nurse before you are given Ontruzant if:
Volumen af det centrale kompartment var 2,62 l hos patienter med MBC og EBC og 3,63 l hos patienter med fremskreden ventrikelkræft.
The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Disse bivirkninger er observeret hos patienter, der behandles med trastuzumab alene eller i kombination med paclitaxel eller docetaxel, især efter kemoterapi indeholdende antracyklin (doxorubicin eller epirubicin).
These events have been observed in patients receiving trastuzumab therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy.
Der må ikke anvendes glucoseholdige opløsninger (se pkt.
Do not use with glucose-containing solutions (see section 6.2).
For at forhindre medicineringsfejl er det vigtigt at kontrollere etiketten på hætteglasset for at sikre, at lægemidlet, der klargøres og administreres, er Ontruzant (trastuzumab) og ikke 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 Ontruzant (trastuzumab) and not trastuzumab emtansine.
I 3 kliniske pivotale studier med adjuverende trastuzumab givet i kombination med kemoterapi var forekomsten af grad 3/4 kardiel dysfunktion (specifikt symptomatisk CHF) tilsvarende hos patienter, der fik administreret kemoterapi alene (d.v.s. ikke fik trastuzumab), og hos patienter, der fik administreret trastuzumab sekventielt efter et 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%).
Efterfølgende vedligeholdelsesdoser af Ontruzant (ugentligt regime: 2 mg/kg, 3-ugers regime 6 mg/kg) skal administreres 7 dage eller 21 dage senere i henhold til planerne for administration henholdsvis ugentligt eller hver 3. uge.
Subsequent Ontruzant maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Der er ikke udført dedikerede farmakokinetiske studier hos ældre og hos personer med nedsat nyreeller leverfunktion.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Generelt anses SISH eller FISH for positiv, hvis forholdet mellem antallet af HER2-genkopier pr. tumorcelle og antallet af kromosom 17-kopier er større end eller lig med 2.
In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
Antracyklinbaseret terapi skal så vidt muligt undgås i op til 7 måneder, efter behandling med trastuzumab er stoppet.
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab.
efter adjuverende kemoterapi med doxorubicin og cyclophosphamid i kombination med paclitaxel eller docetaxel.
following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
Ontruzant i kombination med capecitabin eller 5-fluoruracil og cisplatin er indiceret til behandling af voksne patienter med HER2-positivt metastatisk adenokarcinom i ventriklen eller den gastroøsofageale overgang, som ikke tidligere har fået anticancerbehandling for deres metastatiske sygdom.
Ontruzant in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
I et regime med ugentlig administration er den initiale støddosis 4 mg/kg efterfulgt af 2 mg/kg hver uge samtidig med paclitaxel efter kemoterapi med doxorubicin og cyclophosphamid.
As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
Der er rapporteret svære pulmonale hændelser ved anvendelse af trastuzumab efter markedsføring (se pkt.
Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
Tidlig brystkræft i HERA-studiet var begrænset til operabelt, primært, invasivt adenokarcinom i brystet med positive aksillære lymfeknuder eller negative aksillære lymfeknuder, hvis tumorerne 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.
Trastuzumab og antracykliner bør ikke anvendes i kombination som adjuverende behandling.
Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
I det neoadjuverende-adjuverende studie af tidlig brystkræft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøs 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 intravenous trastuzumab developed antibodies against trastuzumab.
For at undgå fejlmedicinering er det også vigtigt at kontrollere hætteglassets etiket for at sikre, at det lægemiddel, som klargøres og gives, er Ontruzant (trastuzumab) og ikke trastuzumabemtansin.
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is Ontruzant (trastuzumab) and not trastuzumab emtansine.
Parenterale opløsninger skal inspiceres visuelt for partikler og misfarvning før administration.
Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
I studie BO16348 var forekomsten af svær CHF (NYHA-klasse III & IV) i armen med 1-års-trastuzumab-behandling efter en median opfølgning på 8 år 0,8 %, og hyppigheden af let symptomatisk og asymptomatisk venstre ventrikulær dysfunktion 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%.
Som følge heraf har trastuzumab både i in vitro-analyser og hos dyr vist sig at hæmme proliferationen af humane tumorceller med overekspression af HER2.
As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Hyppigheden af progression i leveren var signifikant reduceret hos patienter behandlet med kombinationen af trastuzumab og paclitaxel sammenlignet med paclitaxel alene (21,8 % versus 45,7 %, p = 0,004).
The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%;
Den testmetode for HER2-overekspression, der blev anvendt til bestemmelse af patienternes egnethed i det kliniske pivotale studie med trastuzumab-monoterapi og i kliniske studier med trastuzumab plus paclitaxel, benyttede immunhistokemisk farvning for HER2 af fikseret materiale fra brysttumorer ved anvendelse 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.
Plan for administration hver 3. uge og ugentligt
Three-weekly and weekly schedule
Svære anafylaktiske reaktioner, der kræver øjeblikkelig yderligere intervention, kan forekomme sædvanligvis under enten den første eller anden infusion af trastuzumab (se pkt.
Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Hvis patienten har undladt en dosis af Ontruzant i én uge eller mindre, skal den sædvanlige vedligeholdelsesdosis (ugentligt regime: 2 mg/kg, 3-ugers regime: 6 mg/kg) administreres så hurtigt som muligt.
If the patient has missed a dose of Ontruzant 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.
De opdaterede DFS-analyseresultater (stratificeret HR = 0,61; 95 % CI: 0,54-0,69) viste en lignende gavnlig virkning på DFS sammenlignet med den endelige primære DFS-analyse på trods af de 24,8 % patienter i AC→P-armen, der skiftede til trastuzumab.
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 the 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Trastuzumab har været anvendt i kliniske studier som monoterapi til patienter med MBC, der har tumorer med overekspression af HER2, og som ikke har responderet på et eller flere kemoterapiregimer for deres metastatiske sygdom (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).
Cirkulerende shed HER2-ECD (ekstracellulært domæne af HER2) De eksplorative analyser af kovarianter med information fra kun en undergruppe af patienter tydede på, at patienter med et højere niveau af shed HER2-ECD havde en hurtigere ikke-lineær clearance (lavere Km) (p < 0,001).
The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P<0.001).
Ugentlig dosering ved metastatisk brystkræft Virkningsresultaterne fra studierne med monoterapi og kombinationsterapi er sammenfattet i tabel 4:
Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table 4:
Fulde instruktioner i analysemetode og resultattolkning kan findes i produktinformationsbrochuren, der er vedlagt de anvendte HER2-testanalyser.
Full instructions on assay performance and results interpretation should be taken from the product information leaflet provided with the HER2 testing assays used.
Patienter er egnet til trastuzumab-behandling, hvis de viser potent HER2-overekspression som beskrevet ved en 3+ score ved IHC eller et positivt FISH- eller CISH-resultat.
Patients are eligible for trastuzumab treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Smerter i ekstremitet
Pain in extremity
Det anbefalede scoringssystem til evaluering af IHC-farvningsmønstrene er som anført i tabel 2:
The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2:
Hvis LVEF ikke er forbedret, eller den er faldet yderligere, eller der er udviklet symptomatisk CHF, bør det kraftigt overvejes at afbryde behandlingen med trastuzumab, medmindre det vurderes, at fordelene for den enkelte patient opvejer risiciene.
If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Hvis venstre ventrikel ejektionsfraktions(LVEF)-procent falder ≥ 10 point fra baseline OG til under 50 %, skal behandlingen afbrydes, og LVEF-vurdering gentages inden for ca. 3 uger.
If left ventricular ejection fraction (LVEF) percentage drops ≥10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately
Trastuzumabs farmakokinetik blev evalueret i en populationsfarmakokinetisk modelanalyse ved brug af puljede data fra 1.582 forsøgspersoner, herunder patienter med HER2-positiv MBC, EBC, fremskreden ventrikelkræft eller andre tumortyper og raske forsøgspersoner, i 18 fase I-, II- og IIIstudier, som fik trastuzumab via en intravenøs infusion.
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 via an intravenous infusion.
En del af shed antigens indvirkning på clearance kan muligvis forklares ved SGOT/ASATniveauerne.
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.
• øget muskeltonus eller muskelspænding
(increased muscle tone or tension)
Malign neoplasmaprogression
Malignant neoplasm progression
Der bør anvendes præcise og validerede analysemetoder (se pkt.
Accurate and validated assay methods should be used (see sections 4.4 and 5.1).
Trastuzumab har også været anvendt i kombination med paclitaxel eller docetaxel til behandling af patienter, der ikke har fået kemoterapi for deres metastatiske sygdom.
Trastuzumab has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease.
Data indikerede også, at farmakokinetikken af cisplatin ikke blev påvirket af samtidig anvendelse af capecitabin eller af samtidig anvendelse af capecitabin plus trastuzumab.
The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.
Ét tilfælde 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.
Ontruzant bør kun anvendes til patienter med metastatisk ventrikelkræft (MGC), hvis tumorer har HER2-overekspression defineret ved IHC2+ og et bekræftende SISH- eller FISH-resultat, eller ved et IHC3+ resultat.
Ontruzant should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result.
Tegn og symptomer på kardiel dysfunktion, såsom dyspnø, ortopnø, tiltagende hoste, lungeødem, S3galloprytme eller reduceret ventrikulær uddrivningsfraktion, er observeret hos patienter behandlet med trastuzumab (se pkt.
Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4).
Docetaxel blev administreret som følger: - intravenøs docetaxel - 100 mg/m2 som en intravenøs infusion over 1 time administreret hver 3. uge i 4 cyklusser (dag 2 af første docetaxelcyklus, herefter dag 1 af hver efterfølgende cyklus)
Docetaxel was administered as follows: - intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle)
Farmakokinetiske data fra studie H4613g/GO01305 indikerede, at carboplatin ikke påvirkede farmakokinetikken af trastuzumab.
Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
+ Bivirkninger, der er blevet rapporteret i forbindelse med et dødeligt udfald.
+ Denotes adverse reactions that have been reported in association with a fatal outcome.
Brug af anden medicin sammen med Ontruzant
Other medicines and Ontruzant
Baseline-niveauerne af shed HER2-ECD, der blev observeret hos patienter med MGC, var sammenlignelige med de tilsvarende niveauer hos patienter med MBC og EBC.
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.
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).
Tabel 1 viser bivirkninger, der er blevet rapporteret i forbindelse med anvendelsen af intravenøs trastuzumab alene eller i kombination med kemoterapi i kliniske pivotale studier og efter markedsføring.
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.
Patienter, der oplever hviledyspnø som følge af komplikationer af fremskreden malignitet og komorbiditeter, kan have forøget risiko for pulmonale hændelser.
Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Virkningsresultaterne fra studie BO18225 er sammmenfattet i tabel 13: Tabel 13.
The efficacy results from study BO18225 are summarized in Table 13:
Disse bivirkninger kan være moderate til svære og har været forbundet med dødsfald (se pkt.
These may be moderate to severe and have been associated with death (see section 4.8).