FrancophonIA/ELRC3.0 huggingface dataset:
English: Solutions of Ogivri 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.
Danish: Opløsninger af Ogivri 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.
English: 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.
Danish: I det neoadjuverende-adjuverende studie af tidlig brystkræft (BO22227) udviklede 10,1 % (30/296) af patienterne behandlet med intravenøst trastuzumab antistoffer mod trastuzumab ved en median opfølgningstid på mere end 70 måneder.
English: Ogivri 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.
Danish: Ogivri er et pulver til koncentrat til intravenøs infusionsvæske, opløsning, som leveres i et hætteglas med en gummiprop og indeholder enten 150 mg eller 420 mg trastuzumab.
English: 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
Danish: Hos patienter med tidlig brystkræft, som er egnede til neoadjuverende-adjuverende behandling, bør trastuzumab kun bruges samtidig med antracykliner hos kemoterapi-naive patienter og kun i regimer med lave antracyklindoser dvs. maksimale kumulative doser af doxorubicin 180 mg/m2 eller epirubicin 360 mg/m2.
English: 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).
Danish: Behandling med AC→PH resulterede i en statistisk signifikant forbedring af samlet overlevelse sammenlignet med AC→P (stratificeret risikoforhold = 0,64; 95 % konfidensinterval = 0,55-0,74; log-rank p-værdi < 0,0001).
English: Three -weekly dosing in metastatic breast cancer The efficacy results from the non-comparative monotherapy and combination therapy studies are summarised in Table 5:
Danish: 3-ugers doseringsregime ved metastatisk brystkræft Effektresultaterne fra ikke-komparative studier med monoterapi og kombinationsterapi er sammenfattet i tabel 5:
English: 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.
Danish: Trastuzumab er også blevet anvendt i kombination med paclitaxel eller docetaxel til behandling af patienter, som endnu ikke har fået kemoterapi for deres metastatiske sygdom.
English: 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 (tumor size > 1 cm and ER negative or tumor size > 2 cm, regardless of hormonal status).
Danish: I den samlede analyse af NSABP B-31- og NCCTG N9831-studierne var tidlig brystkræft begrænset til kvinder med operabel brystkræft 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).
English: What Ogivri contains
Danish: Ogivri indeholder:
English: Ogivri 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: Ogivri 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: 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.
Danish: Hos patienter med tidlig brystkræft bør de kardiologiske vurderinger, som blev udført ved baseline, gentages hver 3. måned under behandlingen og hver 6. måned efter behandlingens ophør indtil 24 måneder efter sidste administration af trastuzumab.
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-aspartat-aminotransferase; en del af shed-antigenets indvirkning på clearance kan muligvis forklares ud fra serum-aspartat-aminotransferase-niveauet.
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 risikoforholdet 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: L-histidine hydrochloride, L-histidine, sorbitol, macrogol 3350, hydrochloric acid and sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER L-histidinhydrochlorid, L-histidin, sorbitol, macrogol 3350, saltsyre og natriumhydroxid.
English: Denmark BGP Products ApS Tlf: +45 28116932
Danish: Danmark BGP Products ApS Tlf: +45 28116932
English: If the patient has missed a dose of trastuzumab 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.
Danish: Hvis patienten undlader en dosis af trastuzumab i en uge eller mindre, bør den sædvanlige vedligeholdelsesdosis (ugentligt doseringsregime: 2 mg/kg; 3-ugers doseringsregime: 6 mg/kg) administreres så hurtigt som muligt.
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 mcg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients.
Danish: De ikke-lineære 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 brystkræft, tidlig brystkræft eller fremskreden ventrikelkræft.
English: Patients were recruited to the trial who were previously untreated for HER2-positive inoperable locally advanced or recurrent and/or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction not amenable to curative therapy.
Danish: Patienterne, som blev inkluderet i studiet, var tidligere ubehandlet for HER2-positivt, inoperabelt, lokalt fremskredent eller tilbagevendende og/eller metastatisk adenokarcinom i ventriklen eller den gastroøsofageale overgang, som ikke kunne underkastes en kurativ behandling.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment.
Danish: Hvis du udvikler tegn på hjertesvigt (dårlig pumpefunktion af hjertet), kan din hjertefunktion blive undersøgt oftere (hver 6. til 8. uge).
English: - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease
Danish: - i kombination med docetaxel til behandling af de patienter, som ikke har fået kemoterapi for deres metastatiske sygdom.
English: 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.
Danish: Den mediane opfølgningstid var 2,9 år i AC→D-armen og 3,0 år i hver af AC→DH- og DCarbH-armene.
English: Each 420 mg vial contains 322.6 mg sorbitol (E420).
Danish: Hvert 420 mg hætteglas indeholder 322,6 mg sorbitol (E420).
English: 1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Ogivri, directing the stream into the lyophilised cake.
Danish: 1) Anvend en steril sprøjte og injicer langsomt den passende mængde (som nævnt ovenfor) vand til injektionsvæsker i hætteglasset, som indeholder det frysetørrede Ogivri, idet strålen rettes mod det frysetørrede kompakte pulver.
English: • inability to sleep (insomnia)
Danish: • søvnløshed (insomni)
English: No reactivity or membranous reactivity in any tumour cell
Danish: Ingen reaktivitet eller membranøs reaktivitet i nogen tumorcelle Negativ
English: Do not use Ogivri if you notice any particulate matter or discoloration prior to administration.
Danish: Brug ikke Ogivri, hvis du bemærker nogle partikler eller misfarvning inden brug.
English: In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2).
Danish: I det pivotale studie MO16432 blev trastuzumab administreret samtidig med neoadjuverende kemoterapi, som indeholdt 3 serier med doxorubicin (kumulativ dosis 180 mg/m2).
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Biocon Limited
English: In study MO16432, trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy as follows:
Danish: I studiet MO16432 blev trastuzumab (8 mg/kg støddosis efterfulgt af 6 mg/kg vedligeholdelsesdosis hver 3. uge) administreret samtidig med 10 serier af neoadjuverende kemoterapi på følgende måde:
English: positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Danish: positiv metastisk brystkræft, tydede på, at samtidig administration af trastuzumab ikke påvirkede docetaxels enkeltdosis-farmakokinetik.
English: Pulmonary fibrosis
Danish: +Pulmonal fibrose
English: AUC0-21days (mcg.day/mL)
Danish: AUC0-21dage (µg.dag/ml)
English: If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Danish: Hvis LVEF ikke er forbedret eller er faldet yderligere, eller hvis der er udviklet symptomatisk kongestiv hjerteinsufficiens, bør seponering af trastuzumab kraftigt overvejes, medmindre fordelene for den enkelte patient anses at opveje risiciene.
English: Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
Danish: Farmakokinetiske data fra studie H4613g/GO01305 tydede på, at carboplatin ikke påvirkedetrastuzumabs farmakokinetik.
English: Patients are eligible for Ogivri 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 egnede til behandling med Ogivri, hvis de udviser stærk overekspression af HER2, som beskrevet med en 3+ score ved IHC eller et positivt FISH- eller CISH-resultat.
English: It may take up to 7 months for Ogivri to be removed from your body.
Danish: Det kan tage op til 7 måneder at udskille Ogivri fra kroppen.
English: No reactivity or membranous reactivity in < 10 % of tumour cells
Danish: Ingen reaktivitet eller membranøsreaktivitet i < 10 % af tumorcellerne
English: 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→P H group).
Danish: Den på forhånd planlagte endelige analyse af samlet overlevelse fra den samlede analyse af NSABP B-31- og NCCTG N9831-studierne blev udført, da der var forekommet 707 dødsfald (median opfølgningstid var 8,3 år i AC→PH-gruppen).
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Danish: Farmakokinetiske data fra studierne BO15935 og M77004 udført med kvinder med HER2-positiv metastatisk brystkræft tydede på, at eksponeringen for paclitaxel og doxorubicin (og deres hovedmetabolitter 6-α hydroxylpaclitaxel, POH og doxorubicinol, DOL) ikke blev ændret ved tilstedeværelse af trastuzumab (henholdsvis 8 mg/kg eller 4 mg/kg intravenøs støddosis efterfulgt af 6 mg/kg hver 3. uge eller 2 mg/kg intravenøst hver uge).
English: Primary tumor type
Danish: Primær tumortype
English: - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable
Danish: - i kombination med paclitaxel til behandling af de patienter, som ikke har fået kemoterapi for deres metastatiske sygdom og som ikke er egnede til behandling med et antracyklin.
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Danish: Andre symptomer, som har forbindelse med infusionen, er: utilpashedsfølelse (kvalme), opkastning, smerter, forøget muskelspænding og rystelser, hovedpine, svimmelhed, besvær med at trække vejret, hiven efter vejret, forhøjet eller for lavt blodtryk, forstyrrelser i hjerterytmen (hjertebanken, flakkende hjerte eller uregelmæssig hjerterytme), hævelse i ansigtet og læberne, udslæt og træthedsfølelse.
English: Trastuzumab treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Danish: Behandling med trastuzumab må kun påbegyndes af en læge med erfaring i administration af cytotoksisk kemoterapi (se pkt.
English: Do not administer as an intravenous push or bolus.
Danish: Den må ikke administreres som en intravenøs bolusdosis.
English: Despite the cross-over to trastuzumab in the control arm, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Danish: På trods af overkrydsning til trastuzumab i kontrolarmen resulterede tilføjelse af trastuzumab til paclitaxel-kemoterapi i en 52 % nedsættelse af risikoen for sygdomstilbagefald.
English: EBC in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumors at least 1 cm in diameter.
Danish: Tidlig brystkræft i HERA-studiet var begrænset til operabelt, primært, invasivt adenokarcinom i brystet med positive lymfeknuder i aksillen, eller med negative lymfeknuder i aksillen, hvis tumoren var mindst 1 cm i diameter.
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Danish: Et studie udført på diegivende cynomolgusaber med doser, der er op til 25 gange højere end den humane ugentlige vedligeholdelsesdosis på 2 mg/kg intravenøst formuleret trastuzumab, har vist, at trastuzumab udskilles i mælken.
English: Blood pressure decreased
Danish: 1Formindsket blodtryk
English: • swelling of the face, lips and throat
Danish: • hævelse af ansigtet, læberne og svælget
English: 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.
Danish: De gavnlige effekter, baseret på det kliniske studies resultater, var begrænset til patienter med de højeste niveauer af overekspression af HER2-proteinet, defineret ved en 3+ score ved IHC eller en 2+ score ved IHC og et positivt FISHresultat.
English: 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.
Danish: I løbet af behandlingen skal den kardielle vurdering, som udføres ved baseline, gentages hver tredje måned, og efter seponeringaf behandlingen skal den kardielle vurdering gentages hver sjette måned indtil 24 måneder efter sidste administration af trastuzumab.
English: Hazard Ratio (95 % CI) p = 0.0555
Danish: Risikoforhold (95 % CI) p = 0,0555
English: N Cmin,ss* (mcg/mL)
Danish: N Cmin,ss* (µg/ml)
English: At 8 years, the survival rate was estimated to be 86.9 % in the AC→PH arm and 79.4 % in the AC→P arm, an absolute benefit of 7.4 % (95 % CI 4.9 %, 10.0 %).
Danish: Efter 8 år blev overlevelsesraten estimeret til 86,9 % i AC→PH-armen og 79,4 % i AC→P-armen, hvilket giver en absolut fordel på 7,4 % (95 % konfidensinterval = 4,9 %-10,0 %).
English: Faint ⁄ barely perceptible membranous reactivity in ≥ 10 % of tumour cells; cells are reactive only in part of their membrane
Danish: En svag/lige akkurat synligmembranøs reaktivitet i ≥ 10 % af tumorcellerne; cellerne er kun reaktive i dele af deres membran
English: These are very common (may affect more than 1 in 10 people).
Danish: Disse bivirkninger er meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede).
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95 % CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95 % CI 0.51-0.79) for FP versus FP + H, respectively.
Danish: Den mediane samlede overlevelse for den høje HER2-ekspressionsgruppe var 11,8 måneder versus 16 måneder, risikoforhold 0,65 (95 % konfidensinterval 0,51-0,83), og den mediane progressionsfri overlevelse var 5,5 måneder versus 7,6 måneder, risikoforhold 0,64 (95 % konfidensinterval 0,510,79) for henholdsvis FP og FP+H.
English: 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).
Danish: Der er observeret tegn og symptomer på kardiel dysfunktion såsom dyspnø, ortopnø, tiltagende hoste, lungeødem, S3-galoprytme eller nedsat ventrikulær ejektionsfraktion hos patienter behandlet med trastuzumab (se pkt.
English: • cough,
Danish: • hoste,
English: Distant Recurrence No. patients with event
Danish: Distant tilbagefald Antal patienter med en hændelse
English: In the NSABP B-31 and NCCTG N9831 studies trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Danish: I studierne NSABP B-31 og NCCTG N9831 blev trastuzumab administreret i kombination med paclitaxel efter AC-kemoterapi.
English: 21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Danish: 21 (mg/ml, koncentration af rekonstitueret opløsning) Træk den beregnede volumenmængde af opløsningen ud af hætteglasset og tilsæt den til en infusionspose indeholdende 250 ml 0,9 % natriumchloridopløsning til injektion.
English: White blood cell count decreased/leukopenia
Danish: Nedsat antal hvide blodlegemer/ leukopeni
English: If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF.
Danish: Symptomatisk hjerteinsufficiens opstået under behandling med trastuzumab bør behandles med standardbehandling af kongestiv hjerteinsufficiens.
English: The recommended initial loading dose of trastuzumab is 4 mg/kg body weight.
Danish: Den anbefalede initiale støddosis af trastuzumab er 4 mg/kg legemsvægt.
English: In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 yea r= 0.99 (95 % CI: 0.87, 1.13), p-value = 0.90 and OS HR = 0.98 (0.83, 1.15); pvalue = 0.78].
Danish: I denne endelige analyse viste forlængelse af trastuzumab-behandling til en varighed af 2 år ikke nogen yderligere fordel over behandling i 1 år [sygdomsfri overlevelse risikoforhold i intent-to-treat (ITT)-populationen 2 år versus 1 år = 0,99 (95 % konfidensinterval: 0,87-1,13), p-værdi = 0,90 og samlet overlevelse risikoforhold = 0,98 (0,83-1,15); p-værdi = 0,78].
English: BGP Poducts ApS Tel: +45 28116932 (Danmark)
Danish: BGP Products ApS Tel: +45 28116932 (Danmörk)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ogivri 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ogivri 150 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas indeholder 150 mg trastuzumab, et humaniseret IgG1 monoklonalt antistof, produceret af cellekultursuspension fra pattedyr (ovarie fra kinesisk hamster) og oprenset ved affinitets- og ionbytningskromatografi herunder specifikke virale inaktiverings- og oprensningsprocedurer.
English: For full instructions on assay performance and interpretation please refer to the package inserts of validated FISH and CISH assays.
Danish: For komplet instruktion om udførelse af analyser og fortolkning af resultater henvises til de vedlagte produktinformationer i validerede FISH- og CISH-analyser.
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non-measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)].
Danish: En eksploratorisk subgruppeanalyse udført i studiet ToGA (BO18255) viste, at der ikke var tydelig fordel for den samlede overlevelse ved at tilføje trastuzumab hos patienter med ECOG PS 2 ved baseline [risikoforhold 0,96 (95 % konfidensinterval 0,51-1,79)], med ikke målbar sygdom [risikoforhold 1,78 (95 % konfidensinterval 0,87-3,66)] eller lokalt fremskreden sygdom [risikoforhold 1,20 (95 % konfidensinterval 0,29-4,97)].
English: - The BCIRG 006 study was designed to investigate combining trastuzumab treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
Danish: - Studiet BCIRG 006 var designet til at undersøge kombinationen af trastuzumab-behandling med docetaxel enten efter AC-kemoterapi eller i kombination med docetaxel og carboplatin hos patienter med HER2-positiv tidlig brystkræft efter operation.
English: or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Danish: - intravenøs paclitaxel - 175 mg/m2 som kontinuerlig intravenøs infusion, administreret hver 3. uge i 4 serier (dag 1 i hver serie).