natgillin/translations-raw huggingface dataset:
Et hætteglas med Ontruzant, der er rekonstitueret med vand til injektionsvæsker (følger ikke med) er stabilt i 48 timer efter rekonstitution ved 2 °C-8 °C, og det må ikke nedfryses.
A vial of Ontruzant reconstituted with water for injections (not supplied) is stable for 48 hours at 2ºC - 8ºC after reconstitution and must not be frozen.
Patienter med MBC, der tidligere har fået antracykliner, har også risiko for kardiel dysfunktion ved trastuzumab-behandling, omend risikoen er lavere end ved samtidig anvendelse af trastuzumab og antracykliner.
Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines.
Flere patienter behandlet med trastuzumab og paclitaxel oplevede progression i centralnervesystemet end patienter behandlet med paclitaxel alene (12,6 % versus 6,5 %, p = 0,377).
More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6% versus 6.5%; p=0.377).
I et metodesammenligningsstudie (studie D008548) blev der observeret en høj grad af overensstemmelse (> 95 %) for SISH- og FISH-teknikker til påvisning af HER2-genamplifikation hos patienter med ventrikelkræft.
In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Tilstedeværelsen af anti-trastuzumabantistoffer havde ingen indvirkning på farmakokinetikken, effekten (bestemt ved patologisk fuldstændigt respons og hændelsesfri overlevelse) og sikkerheden, bestemt ved forekomst af administrationsrelaterede reaktioner, af intravenøs trastuzumab syntes.
The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Virkningen af trastuzumab i kombination med paclitaxel hos patienter, der ikke tidligere havde fået adjuverende antracykliner, er ikke blevet undersøgt.
The efficacy of trastuzumab in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Hos patienter med EBC, der er egnet til neoadjuverende-adjuverende behandling, bør trastuzumab kun anvendes samtidig med antracykliner hos kemoterapi-naive patienter og kun i lavdosisregimer af antracyklin, d.v.s. maksimale kumulative doser af doxorubicin på 180 mg/m2 eller epirubicin på 360 mg/m2.
In patients with EBC eligible for neoadjuvant-adjuvant treatment, trastuzumab should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2.
Tilføjelsen af trastuzumab til paclitaxel-kemoterapi resulterede også i et 37 % fald i risikoen for dødsfald.
The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Den mediane varighed af opfølgningen var 2,9 år i AC→D-armen og 3,0 år i hver af AC→DH- og DCarbH-armene.
The median duration of follow up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Resultaterne af dette delstudie indikerede, at eksponeringen for de biologisk aktive metabolitter (f.eks. 5-FU) af capecitabin ikke blev påvirket af samtidig anvendelse af cisplatin eller af samtidig anvendelse af cisplatin plus trastuzumab.
The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab.
Ontruzant kan have en mindre påvirkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
Ontruzant may have a minor influence on the ability to drive or use machines (see section 4.8).
i kombination med en aromatasehæmmer til behandling af postmenopausale patienter med hormonreceptorpositiv MBC, der ikke tidligere er behandlet med trastuzumab.
in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Ontruzant er indiceret til behandling af voksne patienter med HER2-positiv tidlig brystkræft (EBC).
Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Følgende liste over bivirkninger kan forekomme på et hvilket som helst tidspunkt under behandling med Ontruzant, ikke kun i forbindelse med en infusion.
The following list of side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
• søvnighed (døsighed)
• somnolence (sleepiness)
Trastuzumab er blevet undersøgt som adjuverende behandling i 4 store randomiserede multicenterstudier.
In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Der er ikke foretaget reduktioner af dosis af trastuzumab i kliniske studier.
No reductions in the dose of trastuzumab were made during clinical trials.
Kongestiv hjerteinsufficiens (CHF, NYHA-klasse II-IV) er en almindelig bivirkning i forbindelse med anvendelse af trastuzumab og har være forbundet med et dødeligt udfald (se pkt.
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Patienterne skal observeres i mindst 6 timer efter start på den første infusion og i 2 timer efter start på de efterfølgende infusioner for symptomer som feber og kulderystelser eller andre infusionsrelaterede symptomer (se pkt.
Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8).
In vitro trastuzumab-medieret ADCC har vist sig fortrinsvist at blive udøvet på cancerceller med overekspression af HER2, sammenlignet med cancerceller, der ikke har en overekspression af HER2.
In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Trastuzumab binder med høj affinitet og specificitet til subdomæne IV, en juxtamembranregion af HER2's ekstracellulære domæne.
Mechanism of action Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Der blev udført en endelig analyse efter en median opfølgning på 8 år, som viste, at 1 års trastuzumabbehandling er forbundet med en 24 % risikoreduktion sammenlignet med observation alene (HR = 0,76, 95 % CI: 0,67-0,86).
A final analysis was performed after a median follow-up of 8 years, which showed that 1-year trastuzumab treatment is associated with a 24% risk reduction compared to observation only (HR=0.76, 95% CI 0.67, 0.86).
I et efterfølgende studie med prospektiv overvågning af hjertefunktionen var forekomsten af symptomatisk CHF 2,2 % hos patienter, der fik trastuzumab og docetaxel, sammenlignet med 0 % hos patienter, der fik docetaxel alene.
In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2% in patients receiving trastuzumab and docetaxel, compared with 0% in patients receiving docetaxel alone.
Blandt de mest alvorlige og/eller almindelige bivirkninger, der er rapporteret ved anvendelse af Ontruzant til dato er kardiel dysfunktion, infusionrelaterede reaktioner, hæmatotoksicitet (især neutropeni), infektioner og pulmonale bivirkninger.
Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Intravenøs infusion af Ontruzant skal administreres af en læge eller sundhedspersonale, der er i stand til at behandle anafylaksi, og nødudstyr skal være tilgængeligt.
Ontruzant intravenous infusion should be administered by a health-care provider prepared to manage anaphylaxis and an emergency kit should be available.
Risikoen for neutropeni kan være let forhøjet, når trastuzumab administreres med docetaxel efter antracyklinterapi.
The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Det rekonstituerede Ontruzant resulterer i en farveløs til svagt gul, klar opløsning, som skal være i det væsentlige fri for synlige partikler.
The reconstituted Ontruzant results in a colourless to pale yellow transparent solution and should be essentially free of visible particulates.
Ontruzant-opløsninger til intravenøs infusion er fysisk og kemisk stabile i polyvinylchlorid-, polyethylen- eller polypropylenposer, som indeholder natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, i 24 timer ved temperaturer, som ikke overstiger 30 °C.
Solutions of Ontruzant for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Studier af HER2-positivitetsrater ved ventrikelkræft (GC) ved anvendelse af immunhistokemi (IHC) og fluorescens-in situ-hybridisering (FISH) eller kromogen in situhybridisering (CISH) har vist, at der er en bred variation af HER2-positivitet i intervallet fra 6,8 % til 34,0 % for IHC, og 7,1 % til 42,6 % for FISH.
Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH.
Hvis patienten har undladt en dosis af Ontruzant i mere end én uge, skal en ny støddosis af Ontruzant administreres over ca. 90 minutter (ugentligt regime: 4 mg/kg, 3-ugers regime: 8 mg/kg) så hurtigt som muligt.
If the patient has missed a dose of Ontruzant by more than one week, a re-loading dose of Ontruzant should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Hvis patienten fortsat har en nedsat funktion af venstre ventrikel, men forbliver asymptomatisk, bør lægen overveje at seponere behandlingen med trastuzumab, hvis der ikke er observeret nogen klinisk gavnlig virkning heraf.
If patients have a continued decrease in left ventricular function, but remain asymptomatic, the physician should consider discontinuing therapy if no clinical benefit of trastuzumab therapy has been seen.
• hvis du er allergisk over for trastuzumab, murine (muse) proteiner eller et af de øvrige indholdsstoffer i Ontruzant (angivet i punkt 6).
• you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
De fleste patienter, der udviklede CHF eller asymptomatisk kardiel dysfunktion i de pivotale studier, opnåede en bedring med standardbehandling af CHF bestående af en ACE (angiotensin-omdannende enzym)-hæmmer eller angiotensinreceptorblokker (ARB) og en betablokker.
Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Instruktioner til rekonstitution
Instructions for reconstitution
som monoterapi til behandling af de patienter, der har fået mindst to kemoterapiregimer for deres metastatiske sygdom.
as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
I ToGA-studiet (BO18255) blev patienter, hvis tumorer var enten IHC3+ eller FISH-positive, defineret som HER2-positive og derfor inkluderet i studiet.
In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial.
I studie BCIRG 006 havde 213/1075 patienter i DCarbH (TCH)-armen, 221/1074 patienter i AC→DH (AC→TH)-armen og 217/1073 i AC→D (AC→T)-armen en Karnofsky performance status ≤ 90 (enten 80 eller 90).
In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Pakningsstørrelser og yderligere oplysninger Ontruzant indeholder
Contents of the pack and other information What Ontruzant contains
For patienter med EBC skal kardielle vurderinger, som udføres ved baseline, gentages hver 3. måned under behandlingen og hver 6. måned efter behandlingsophør, indtil 24 måneder efter den sidste administration af trastuzumab.
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 trastuzumab.
De ikke-lineære eliminationsparametre var 8,81 mg/dag for den maksimale eliminationshastighed (Vmax) og 8,92 µg/ml for Michaelis-Menten kontanten (Km) hos patienter med MBC, EBC eller fremskreden ventrikelkræft.
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.
I ét af de 3 udførte pivotale studier, hvor en median opfølgning på 5,5 år var tilgængelig (BCIRG006), blev der observeret en kontinuerlig stigning i den kumulative hyppighed af symptomatiske kardielle hændelser eller LVEF-hændelser hos patienter, der fik administreret trastuzumab samtidig med et taxan efter antracyklin-terapi, på op til 2,37 % sammenlignet med ca. 1 % i de to komparatorarme (antracyklin plus cyclophosphamid efterfulgt af taxan og taxan, carboplatin og trastuzumab).
In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Ontruzant kan ordineres i kombination med kemoterapilægemidlerne paclitaxel og docetaxel som første behandling for metastatisk brystkræft, eller det kan ordineres alene, hvis andre behandlinger har vist sig ikke at virke.
Ontruzant may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Der henvises til produktresuméet for paclitaxel, docetaxel eller aromatasehæmmer for information om dosisreduktion eller udsættelse af behandling.
Refer to the SmPC for paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med trastuzumab i alle undergrupper af den pædiatriske population ved brystkræft og ventrikelkræft (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Der er forekommet svære pulmonale bivirkninger i forbindelse med anvendelsen af trastuzumab, som har været forbundet med et dødeligt udfald.
Severe pulmonary adverse reactions occur in association with the use of trastuzumab and have been associated with a fatal outcome.
Kvinder i den fertile alder skal rådes til at anvende sikker kontraception under behandlingen med trastuzumab og i 7 måneder, efter behandlingen er afsluttet (se pkt.
Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Patienter, der blev randomiseret til at få trastuzumab, fik administreret en initial støddosis på 8 mg/kg, efterfulgt af 6 mg/kg hver 3. uge i enten 1 eller 2 år.
Patients assigned to receive trastuzumab were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years.
Studie WO16229: støddosis 8 mg/kg, efterfulgt af 6 mg/kg hver 3. uge Studie MO16982: støddosis 6 mg/kg ugentligt x 3, efterfulgt af 6 mg/kg hver 3. uge Studie BO15935
Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
i kombination med adjuverende kemoterapi bestående af docetaxel og carboplatin.
in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Den mediane varighed af opfølgningen var 1,8 år for patienterne i AC→P-armen og 2,0 år for patienterne i AC→PH-armen.
The median duration of follow-up was 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm.
Den kardielle vurdering, som udføres ved baseline, skal gentages hver 3. måned under behandlingen og hver 6. måned efter behandlingsseponering, indtil 24 måneder efter den sidste administration af trastuzumab.
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 trastuzumab.
Ontruzant er indiceret til behandling af voksne patienter med HER2-positiv metastatisk brystkræft (MBC):
Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Sygdomsfri overlevelse Antal patienter med hændelse (%)
Disease-free survival No. patients with event (%)
Påvisning af HER2-overekspression eller HER2-genamplifikation
Detection of HER2 overexpression or HER2 gene amplification
Virkningsresultaterne fra BO16348-studiet efter en median opfølgning på 12 måneder* og 8 år** er sammenfattet i tabel 6:
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Trastuzumab er et rekombinant humaniseret IgG1-monoklonalt antistof mod den humane epidermale vækstfaktorreceptor 2 (HER2).
Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2).
Kombinationsbehandling med trastuzumab og anastrozol Trastuzumab er blevet undersøgt i kombination med anastrozol til førstelinjebehandling af MBC hos hormonreceptor (d.v.s. østrogenreceptor (ER) og/eller progesteronreceptor (PR))-positive postmenopausale patienter med HER2-overekspression.
Combination treatment with trastuzumab and anastrozole 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.
- capecitabin - 1000 mg/m2 oralt to gange dagligt i 14 dage hver 3. uge i 6 cyklusser (aften på dag 1 til morgen på dag 15 af hver cyklus)
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Infusionen kan fortsættes, når symptomerne er bedret.
The infusion may be continued after the symptoms improve.
Patienter, der får antracykliner, efter de er stoppet med trastuzumab, kan muligvis have øget risiko for kardiel dysfunktion.
Patients who receive anthracyclines after stopping trastuzumab may possibly be at increased risk of cardiac dysfunction.
i kombination med neoadjuverende kemoterapi efterfulgt af adjuverende Ontruzant-terapi til lokalt fremskreden (herunder inflammatorisk) sygdom eller tumorer > 2 cm i diameter (se pkt.
in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1).
Generelt anses 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, eller hvis der er mere end 4 kopier af HER2-genet pr. tumorcelle, hvis der ikke anvendes en kromosom 17-kontrol.
In general, 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, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
Endvidere er trastuzumab en potent mediator af antistofafhængig cellemedieret cytotoksicitet (ADCC).
Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Post-hoc eksplorativ analyse med DFS og symptomatiske kardielle hændelser Langtidsopfølgning** hazard ratio (95 % CI) A: doxorubicin, C: cyclophosphamid, P: paclitaxel, D: docetaxel, Carb: carboplatin, H: trastuzumab CI = konfidensinterval * På tidspunktet for den endelige analyse af DFS.
Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up** hazard ratios (95% CI) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS.
- Studie BO16348 var designet til at sammenligne 1 og 2 års behandling med trastuzumab hver 3. uge versus observation hos patienter med HER2-positiv EBC 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).
Administration i kombination med paclitaxel eller docetaxel I de pivotale studier (H0648g, M77001) blev paclitaxel eller docetaxel administreret dagen efter den første dosis af trastuzumab (for dosis se produktresuméet for paclitaxel eller docetaxel) og umiddelbart efter de efterfølgende doser af trastuzumab, hvis den forudgående dosis af trastuzumab var veltolereret.
Administration in combination with paclitaxel or 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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1241/001
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1241/001
Alle kandidater til behandling med trastuzumab, men især de der tidligere har været eksponeret for antracyklin og cyclophosphamid (AC), skal have foretaget en kardiel vurdering ved baseline, herunder anamnese og objektiv undersøgelse, elektrokardiogram (EKG), ekkokardiogram og/eller MUGA (multigated acquisition)-scanning eller MR (magnetisk resonans)-scanning.
All candidates for treatment with trastuzumab, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Der var ingen tidsmæssige restriktioner for administrationen af trastuzumab og anastrozol (for dosis se produktresuméet for anastrozol eller andre aromatasehæmmere).
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).