FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with HER2+ tumours were randomised to receive either neoadjuvant chemotherapy concurrently with neoadjuvant-adjuvant Herceptin, or neoadjuvant chemotherapy alone.
Danish: Patienter med HER2+ tumorer blev randomiseret til at få enten neoadjuverende kemoterapi samtidig med neoadjuverende-adjuverende Herceptin eller neoadjuverende kemoterapi alene.
English: If the patient has missed a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Danish: Hvis patienten undlader en dosis af Herceptin i mere end en uge, bør der administreres en ny støddosis af Herceptin over ca. 90 minutter (ugentligt doseringsregime: 4 mg/kg; 3-ugers doseringsregime: 8 mg/kg) så hurtigt som muligt.
English: Some of the side effects you experience may be due to your underlying breast cancer.
Danish: Nogle af de bivirkninger, som du oplever, kan skyldes din brystkræft.
English: • the other is given as a subcutaneous injection over 2 to 5 minutes.
Danish: • den anden gives som indsprøjtning under huden over 2-5 minutter.
English: 1 Blood pressure increased
Danish: 1Forhøjet blodtryk
English: All of the severe ARRs with the Herceptin subcutaneous formulation occurred during concurrent administration with chemotherapy.
Danish: Alle svære administrationsrelaterede reaktioner ved Herceptin subkutan formulering opstod ved samtidig administration af kemoterapi.
English: Subsequent Herceptin 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.
Danish: Efterfølgende vedligeholdelsesdoser af Herceptin (henholdsvis ugentligt doseringsregime: 2 mg/kg; 3-ugers doseringsregime: 6 mg/kg) bør administreres 7 eller 21 dage senere i henhold til henholdsvis ugentlige eller 3-ugers doseringsregimer.
English: Congestive heart failure (NYHA Class II-IV) is a common adverse reaction to Herceptin.
Danish: Kongestiv hjerteinsufficiens (NYHA-klasse II-IV) er en almindelig bivirkning ved Herceptin.
English: The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection.
Danish: Lokale reaktioner inkluderede erythema, kløe, ødem, udslæt og smerte ved injektionsstedet.
English: What you need to know before you are given Herceptin Do not use Herceptin if:
Danish: Det skal du vide, før du begynder at få Herceptin Du må ikke få Herceptin, hvis:
English: It may take up to 7 months for Herceptin to be removed from the body.
Danish: Det kan tage op til 7 måneder at udskille Herceptin fra organismen.
English: So far, no results are available which compare the efficacy of Herceptin administered with chemotherapy in the adjuvant setting with that obtained in the neo-adjuvant/adjuvant setting.
Danish: Der er ingen tilgængelige resultater, der sammenligner virkningen af Herceptin, administreret med kemoterapi i den adjuverende behandling, med virkningen i den neoadjuverende-adjuverende behandling.
English: In addition, treatment of lower body weight patients with Herceptin subcutaneous fixed dose in adjuvant EBC was not associated with increased safety risk, adverse events and serious adverse events, compared to the higher body weight patients.
Danish: Derudover var behandling af adjuverende tidlig brystkræft med Herceptin subkutan fast dosis hos patienter med lav kropsvægt ikke associeret med øget sikkerhedsrisiko og bivirkninger herunder alvorlige bivirkninger sammenlignet med patienter med højere kropsvægt.
English: No loading dose is required.
Danish: Støddosis er ikke nødvendig.
English: In patients receiving Herceptin after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of Herceptin and a body mass index (BMI) >25 kg/m2.
Danish: Risikoen for kardiel dysfunktion hos patienter, der fik Herceptin efter afsluttet adjuverende kemoterapi, var associeret med en højere kumulativ antracyklin-dosis, givet før initiering af Herceptin, og et body mass index (BMI) > 25 kg/m2.
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Danish: - i kombination med neoadjuverende kemoterapi efterfulgt af adjuverende Herceptin-behandling for lokalt avanceret (herunder inflammatorisk) sygdom eller tumorer > 2 cm i diameter (se pkt.
English: A total of 595 patients with HER2-positive, operable or locally advanced breast cancer (LABC) including inflammatory breast cancer received eight cycles of either Herceptin intravenous formulation or Herceptin subcutaneous formulation concurrently with chemotherapy (4 cycles of docetaxel, 75 mg/m2 intravenous infusion, followed by 4 cycles of FEC ([5-Fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamide, 500 mg/m2 each intravenous bolus or infusion]), followed by surgery, and continued therapy with Herceptin intravenous formulation or Herceptin subcutaneous formulation as originally randomized for 10 additional cycles, for a total of one year of treatment.
Danish: I alt 595 patienter med HER2positiv operabel eller lokalt avanceret brystkræft, inklusive inflammatorisk brystkræft, modtog 8 serier af enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering samtidigt med kemoterapi (4 serier docetaxel, 75 mg/m2 intravenøs infusion, efterfulgt af 4 serier af FEC ([5fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamid, 500 mg/m2 hver enkelt som intravenøs bolus eller infusion]), efterfulgt af operation og fortsat behandling i yderligere 10 serier til i alt et års behandling med enten intravenøst formuleret Herceptin eller Herceptin subkutan formulering efter den originale randomisering.
English: At the time of the definitive analysis of DFS.
Danish: På tidspunktet for den endelige analyse af sygdomsfri overlevelse.
English: After a median follow-up of
Danish: Den mediane opfølgningstid var
English: 1 Denotes adverse reactions that are reported largely in association with Infusion-related reactions.
Danish: Angiver bivirkninger, som er rapporteret i stor udstrækning i forbindelse med infusionsrelaterede reaktioner.
English: Cycle 1 297 Cycle 7 (steady state)
Danish: Serie 7 (steady state)
English: Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Danish: Alvorlige reaktioner fra intravenøst Herceptin er blevet behandlet succesfuldt med understøttende behandling såsom ilt, beta-agonister og kortikosteroider.
English: Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiac dysfunction.
Danish: Patienter, som får antracykliner efter ophør af Herceptin-behandling, kan muligvis have øget risiko for kardiel dysfunktion.
English: The final analysis at a median follow-up exceeding 70 months showed similar EFS and OS between patients who received Herceptin IV and those who received Herceptin SC.
Danish: Den endelige analyse ved en median opfølgningstid på mere end 70 måneder viste lignende hændelsesfri overlevelse og samlet overlevelse mellem de patienter, der fik Herceptin intravenøst, og de, der fik Herceptin subkutant.
English: Administration-related reactions (ARRs) are known to occur with Herceptin subcutaneous formulation.
Danish: Det er kendt, at administrationsrelaterede reaktioner kan opstå i forbindelse med Herceptin subkutan formulering.
English: Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Danish: Begge blev administreret med: cisplatin - 80 mg/m2 hver 3. uge i 6 serier på dag 1 i hver serie.
English: You will be observed by a healthcare professional during the administration and for six hours after the start of the first administration and for two hours after the start of other administrations.
Danish: Du vil blive observeret af sundhedspersonalet under administrationen og i mindst seks timer efter påbegyndelse af den første administration og i to timer efter påbegyndelse af de efterfølgende administrationer.
English: AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
Danish: kemoterapi (AC→DH) eller i kombination med docetaxel og carboplatin (DCarbH).
English: Primary tumor type and Regimen
Danish: Primær tumor type og doseringsregimen
English: Caution is recommended with Herceptin subcutaneous formulation as severe pulmonary events have been reported with the use of the intravenous formulation in the post-marketing setting (see section 4.8).
Danish: Det anbefales, at udvise forsigtighed med Herceptin subkutan formulering, da der er rapporteret om alvorlige pulmonale bivirkninger ved anvendelse af den intravenøse formulering efter markedsføringen (se pkt.
English: If during treatment, you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Danish: Hvis du under behandlingen får symptomer såsom kulderystelser eller feber, må du ikke køre bil, motorcykel, cykle eller betjene maskiner før, symptomerne er forsvundet.
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herceptin treatment, although the risk is lower than with concurrent use of Herceptin and anthracyclines.
Danish: Patienter med metastatisk brystkræft, som tidligere har fået antracykliner, er også i risikogruppe for kardiel dysfunktion ved Herceptin-behandling, selvom risikoen er lavere end ved samtidig brug af Herceptin og antracykliner.
English: (95 % CI) p-value
Danish: (95 % konfidensinterval) p-værdi
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up** Hazard ratios (95 % CI)
Danish: Post-hoc eksplorativ analyse med sygdomsfri overlevelse og symptomatiske kardielle hændelser længerevarende opfølgning** hazard ratio 95 % konfidensinterval
English: Herceptin should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Danish: Herceptin skal inspiceres visuelt for at sikre, at der ikke er partikler eller misfarvning før administration.
English: Herceptin may affect your ability to drive a car or operate machines.
Danish: Herceptin kan påvirke din evne til at køre bil, cykle og betjene maskiner.
English: Herceptin has also been used in combination with paclitaxel or docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease.
Danish: Herceptin er også blevet anvendt i kombination med paclitaxel eller docetaxel til behandling af patienter, som ikke har fået kemoterapi for deres metastatiske sygdom.
English: Death (OS event)
Danish: Død (OS-hændelse):
English: No incompatibilities between Herceptin subcutaneous formulation and polypropylene or polycarbonate syringe material or stainless steel transfer and injection needles and polyethylene Luer cone stoppers have been observed.
Danish: Der er ikke observeret uforligelighed mellem Herceptin subkutan formulering og polypropylen- eller polykarbonatmaterialet i sprøjter eller rustfrit stål i overførsels- og injektionskanyler og polyethylenLuer-propper.
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in patients receiving Herceptin and docetaxel, compared with 0 % in patients receiving docetaxel alone.
Danish: I et efterfølgende studie med prospektiv monitorering af hjertefunktionen var incidensen af symptomatisk kongestiv hjerteinsufficiens 2,2 % hos patienter, der fik Herceptin og docetaxel, sammenlignet med 0 % hos patienter, der fik doxetaxel alene.
English: Herceptin SC (N=260)
Danish: Herceptin subkutant (N = 260)
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, betaagonists, and corticosteroids.
Danish: Alvorlige reaktioner er blevet behandlet succesfuldt med understøttende behandling såsom ilt, beta-agonister og kortikosteroider.
English: The preoperative chemotherapy regimen consisted of docetaxel (75 mg/m²) followed by FEC (5FU, epirubicin and cyclophosphamide) at a standard dose.
Danish: Kemoterapiregimet før operation bestod af docetaxel (75 mg/m2) efterfulgt af standarddoser FEC (5-fluorouracil, epirubicin og cyclophosphamid).
English: Patients with EBC should be treated with Herceptin for 1 year or until disease recurrence, whichever occurs first; extending treatment in EBC beyond one year is not recommended (see section 5.1).
Danish: Patienter med tidlig brystkræft bør behandles med Herceptin i 1 år, eller indtil sygdommen recidiverer afhængigt af, hvad der forekommer først; forlængelse af behandling af tidlig brystkræft udover et år anbefales ikke (se pkt.
English: There were no restrictions on the relative timing of Herceptin and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).
Danish: Der var ingen tidsmæssige restriktioner for administrationen af Herceptin og anastrozol (se dosis i produktresuméet for anastrazol eller andre aromatasehæmmere).
English: • Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på den ydre pakning og på etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Patients are eligible for Herceptin treatment if they show strong HER2 overexpression as described by a 3+ score by IHC or a positive FISH or CISH result.
Danish: Patienterne er valgbare for behandling med Herceptin, hvis de udviser stærk overekspression af HER2, som beskrevet med en 3+ score ved IHC eller et positivt FISH eller CISH resultat.
English: 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.
Danish: Der var en sammenhæng 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.
English: In the pivotal trial (BO22227) Herceptin subcutaneous formulation was administered in the neoadjuvant/adjuvant setting in patients with early breast cancer.
Danish: I det pivotale studie (BO22227) blev Herceptin subkutan formulering administreret til neoadjuverende/adjuverende behandling hos patienter med tidlig brystkræft.
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of Herceptin with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant Herceptin, up to a total treatment duration of 1 year.
Danish: I den neoadjuverende-adjuverende behandling var studie MO16432, et multicenter randomiseret studie, designet til at undersøge den kliniske virkning af samtidig administration af Herceptin og neoadjuverende kemoterapi inkluderende både et antracyklin og et taxan, efterfulgt af adjuverende Herceptin til en total behandlingsvarighed på 1 år.
English: One vial of 5 mL contains 600 mg of trastuzumab.
Danish: Et hætteglas på 5 ml indeholder 600 mg trastuzumab.
English: D-79639 Grenzach-Wyhlen Germany
Danish: 79639 Grenzach-Wyhlen Tyskland
English: Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial.
Danish: Stærk skumdannelse under rekonstitueringen eller omrysten af det rekonstituerede Herceptin kan medføre problemer med hensyn til den mængde Herceptin, der kan trækkes op af hætteglasset.
English: Herceptin 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 gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Danish: Herceptin er, i kombination med capecitabin eller 5-fluoruracil og cisplatin, indiceret til behandling af voksne patienter med HER2-positivt metastatisk adenokarcinom i ventriklen eller den gastroøsofageale overgang, som ikke tidligere har fået anticancer-behandling for deres metastatiske sygdom.
English: • Serious adverse events (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation): 14.1 % for the intravenous formulation versus 21.5 % for the subcutaneous formulation.
Danish: • Alvorlige bivirkninger (hvoraf de fleste blev identificeret ved indlæggelse på sygehus eller forlængelse af indlæggelse): 14,1 % i den intravenøse formulering versus 21,5 % i den subkutane formulering.
English: The rate of severe infections (NCI CTCAE grade ≥3) was 5.0 % versus 7.1 %, in the Herceptin intravenous formulation arm and the Herceptin subcutaneous formulation arm respectively.
Danish: Hyppigheden af svære infektioner (NCI CTCAE grad ≥ 3) var 5,0 % versus 7,1 % i henholdsvis armen med intravenøst formuleret Herceptin og armen med subkutant formuleret Herceptin.
English: Combination treatment with Herceptin and anastrozole Herceptin 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.
Danish: Kombinationsbehandling med Herceptin og anastrozol Herceptin er blevet undersøgt i kombination med anastrozol ved 1. linjebehandling af metastatisk brystkræft hos HER2-positive, hormon-receptor-positive (dvs. østrogen-receptor og/eller progesteronreceptor) postmenopausale patienter.
English: • increased muscle tone or tension (hypertonia)
Danish: • øget muskeltonus eller muskelspænding
English: Neutralizing anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm.
Danish: Neutraliserende anti-trastuzumab-antistoffer blev fundet i prøver efter baseline hos 2 ud af 30 patienter i armen behandlet med intravenøst Herceptin.
English: 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.
Danish: 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.
English: No reactivity or membranous reactivity in < 10 % of tumour cells
Danish: Ingen reaktivitet eller membranøs reaktivitet i < 10 % af tumorcellerne
English: Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulations and vice versa, using the three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see section 4.8).
Danish: Skift mellem Herceptin intravenøs og Herceptin subkutan formulering og omvendt i et 3-ugers doseringsregime blev undersøgt i studie MO22982 (se pkt.
English: During the adjuvant phase of treatment, at the pre-dose Cycle 13 time point, the mean Ctrough values were 90.4 µg/mL and 62.1 µg/mL, respectively.
Danish: I den adjuverende behandlingsfase på tidspunktet før dosis i 13. serie var gennemsnitsværdierne af Ctrough henholdsvis 90,4 mikrogram/ml og 62,1 mikrogram/ml.
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the Herceptin 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
Danish: I studie BO16348 var incidensen af svær kongestiv hjerteinsufficiens (NYHA-klasse III & IV) efter 1 års Herceptin-behandling 0,8 % efter en median opfølgning på 8 år, og hyppigheden af let symptomatisk og asymptomatisk dysfunktion af venstre ventrikel var 4,6 %.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Danish: Risikofaktorer for en kardiel bivirkning blev identificeret i fire store adjuverende studier og inkluderede alder (> 50 år), lav LVEF (< 55 %) ved baseline før eller efter initiering af paclitaxelbehandling, fald i LVEF på 10-15 point samt tidligere eller samtidig brug af antihypertensiva.
English: 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 Herceptin.
Danish: Resultaterne af dette substudie tydede på, at eksponeringen for capecitabins biologisk aktive metabolitter (f.eks. 5-FU) ikke blev påvirket af samtidig anvendelse af cisplatin eller cisplatin plus Herceptin.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Kun til intravenøs anvendelse efter rekonstituering og fortynding Læs indlægssedlen inden brug
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without Herceptin.
Danish: Studie JP19959, et substudie i BO18255 (ToGA), blev udført hos japanske mænd og kvinder med fremskreden ventrikelkræft for at undersøge capecitabins og cisplatins farmakokinetik, når de blev anvendt med eller uden Herceptin.
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH
Danish: I BCIRG 006-studiet havde 213/1.075 patienter i DCarbH (TCH)-armen, 221/1.074 patienter i
English: For instructions on use and handling of Herceptin subcutaneous formulation refer to section 6.6.
Danish: 6.6 for instruktioner vedrørende anvendelse og håndtering af Herceptin subkutan formulering.
English: Herceptin subcutaneous formulation is a ready to use solution which should not be mixed or diluted with other products.
Danish: Herceptin subkutan formulering er en opløsning, der er klar til brug og skal ikke blandes eller fortyndes med andre lægemidler.
English: 1 Blood pressure decreased
Danish: 1Formindsket blodtryk
English: During a Herceptin infusion, chills, fever and other flu like symptoms may occur.
Danish: Under en Herceptin-infusion kan der forekomme kulderystelser, feber og andre influenzalignende symptomer.
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2: Recommended scoring system to evaluate the IHC staining patterns Score Staining pattern
Danish: Det anbefalede scoringssystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 2: Tabel 2: Anbefalet scoringssystem til evaluering af IHC-farvede mønstre Score
English: In the neoadjuvant setting, the experience of concurrent administration of Herceptin and low dose anthracycline regimen is limited (see section 4.4).
Danish: Ved neoadjuverende behandling er erfaringen med samtidig administration af Herceptin og et lav-dosis antracyklin-regime begrænset (se pkt.
English: Currently no data from clinical trials are available on re-treatment of patients with previous exposure to Herceptin in the adjuvant setting.
Danish: Der foreligger ingen tilgængelige data fra kliniske studier for genbehandling hos patienter, der tidligere har fået adjuverende behandling med Herceptin.
English: Pre-medication may be used to reduce risk of occurrence of ARRs.
Danish: Præmedicinering kan anvendes for at reducere risikoen for, at administrationsrelaterede reaktioner opstår.
English: The efficacy results from the BCIRG 006 are summarized in Tables 8 and 9.
Danish: Effektresultaterne fra BCIRG 006-studiet er sammenfattet i tabel 8 og 9.