natgillin/translations-raw huggingface dataset:
Det skal du vide, før du begynder at få Perjeta
What you need to know before you are given Perjeta
Blandt de asiatiske patienter var forekomsten af febril neutropeni højere i Perjeta-gruppen (25,8%) end i placebo-gruppen (11,3%).
Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).
• Første gang vil mængden af medicin og længden af infusionen være en anden end de efterfølgende gange.
The amount of medicine you are given and how long the infusion will last are different for the first dose and following doses.
Type og sværhedsgrad af hændelserne var i overensstemmelse med dem observeret i CLEOPATRA-studiet ved serierne, hvor Perjeta blev givet på den samme dag som trastuzumab og docetaxel.
The type and severity of events were consistent with those observed in CLEOPATRA at the cycles when Perjeta was given on the same day as trastuzumab and docetaxel, with the majority of reactions being mild or moderate in severity.
Som neoadjuverende behandling skal Perjeta administreres i kombination med trastuzumab og kemoterapi i 3 til 6 serier, som led i et komplet behandlingsregime for tidlig brystkræft (se pkt.
In the neoadjuvant setting, Perjeta should be administered for 3 to 6 cycles in combination with trastuzumab and chemotherapy, as part of a complete treatment regimen for early breast cancer (see section 5.1).
Hoste Epistaxis Dyspnø
Cough Epistaxis Dyspnoea
I CLEOPATRA-studiet med metastatisk brystkræft var nadirneutrofiltallene ens hos Perjeta-behandlede patienter og placebo-behandlede patienter.
In the CLEOPATRA trial in metastatic breast cancer, nadir neutrophil counts were similar in Perjeta-treated and placebo-treated patients.
Perjeta kan fremkalde svær diarré.
Perjeta may elicit severe diarrhoea.
Overfølsomhedsreaktioner/anafylaksi
Hypersensitivity reactions/anaphylaxis
Patienter med metastatisk brystkræft
Patients with metastatic breast cancer
Som i CLEOPATRA-, TRYPHAENA- og NEOSPHEREstudierne blev der i APHINITY-studiet observeret en højere forekomst af febril neutropeni blandt Perjeta-behandlede asiatiske patienter sammenlignet med patienter af anden oprindelse (15,9% af Perjeta-behandlede patienter og 9,9% af placebo-behandlede patienter).
As in the CLEOPATRA, TRYPHAENA, and NEOSPHERE trials, a higher incidence of febrile neutropenia was observed among Perjeta-treated Asian patients compared with other races in the APHINITY trial (15.9% of Perjeta-treated patients and 9.9% of placebo-treated patients).
Perjeta er ikke undersøgt hos patienter med LVEF-værdier < 50% inden behandling, kongestivt hjerteinsufficiens (CHF) i anamnesen, LVEF-fald til < 50% under tidligere adjuverende behandling med trastuzumab eller tilstande, der kan nedsætte venstre ventrikel funktionen, fx ukontrolleret hypertension, nyligt myokardieinfarkt, alvorlig behandlingskrævende hjertearytmi eller tidligere antracyklin-behandling til kumuleret dosis > 360 mg/m2 doxorubicin eller tilsvarende behandling ækvivalent hermed.
Perjeta has not been studied in patients with: a pre-treatment LVEF value of < 50%; a prior history of congestive heart failure (CHF); LVEF declines to < 50% during prior trastuzumab adjuvant therapy; or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to > 360 mg/m2 of doxorubicin or its equivalent.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 420 mg/14 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 420 mg/14 ml
† Evalueret hos patienter, hvor bedste samlede respons var komplet respons eller partielt respons ^ Objektiv responsrate og varighed af respons er baseret på den uafhængige vurdering af tumor.
† Evaluated in patients with Best Overall Response of CR or PR. ^ Objective response rate and duration of response are based on IRF-assessed tumour assessments.
Der er gennemført reproduktions-toksikologiske studier med drægtige cynomolgus-aber (fra gestationsdag 19 til og med gestationsdag 50) med initialdoser på 30 til 150 mg/kg efterfulgt af doser på 10 til 100 mg/kg to gange om ugen.
Reproductive toxicology studies have been conducted in pregnant cynomolgus monkeys (Gestational Day (GD) 19 through to GD 50) at initial doses of 30 to 150 mg/kg followed by bi-weekly doses of 10 to 100 mg/kg.
Perjeta bør seponeres, hvis symptomatisk hjerteinsufficiens bekræftes (se pkt.
Perjeta should be discontinued if symptomatic heart failure is confirmed (see section 4.4 for more details).
I den anden serie, hvor alle lægemidlerne blev administreret samme dag, var de hyppigste infusionsreaktioner (≥ 1,0%) i Perjeta-gruppen: træthed, smagsforstyrrelser, lægemiddeloverfølsomhed, myalgi og opkastning (se pkt.
During the second cycle when all medicinal products were administered on the same day, the most common infusion reactions in the Perjeta-treated group (≥ 1.0%) were fatigue, dysgeusia, drug hypersensitivity, myalgia and vomiting (see section 4.4).
Tumorlyse syndrom†
Tumour lysis syndrome†
Fast dosis af 600 mg trastuzumab subkutan administreres så hurtigt som muligt.
The fixed dose of 600mg trastuzumab SC should be administered as soon as possible.
HR = hazard ratio, CI = konfidensinterval, Pla = placebo, Ptz = pertuzumab (Perjeta), T = trastuzumab (Herceptin), D = docetaxel.
HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
Fra den globale sikkerhedsdatabase tilhørende indehaveren af markedsføringstilladelsen er i alt indhentet 15 sagsrapporter inklusive MedDRA PT's potentielt indikerende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed, hvilket var associeret med dødeligt udfald.
From the global safety database of the MAH a total of 15 case reports were retrieved inculding MedDRA PTs potentially indicative of an IRR or hypersensitivity/anaphylaxis which were associated with fatal outcome.
Perjeta er i kombination med trastuzumab og docetaxel indiceret til voksne patienter med HER2positiv, metastatisk eller lokalt recidiverende, ikke-resecérbar brystkræft og som ikke tidligere har fået anti-HER2-behandling eller kemoterapi for deres metastatiske sygdom.
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Baseret på den populationsfarmakokinetiske analyse var eksponeringen af pertuzumab hos patienter med let nedsat nyrefunktion (kreatininclearance 60-90 ml/min, n = 200) og hos patienter med moderat nedsat nyrefunktion (kreatinclearance 30-60 ml/min, n = 71) sammenlignelig med eksponeringen hos patienter med normal nyrefunktion (kreatininclearance større end 90 ml/min, n = 200).
Based on the results of the population pharmacokinetic analysis, pertuzumab exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Pertuzumabeksponering blev rapporteret hos afkommet fra alle behandlede grupper i niveauer fra 29% til 40% af den maternale serumkoncentration på gestationsdag 100.
Pertuzumab exposure was reported in offspring from all treated groups, at levels of 29% to 40% of maternal serum levels at
Infusionen bør straks og permanent afbrydes, hvis patienten udvikler en NCI-CTCAE grad 4-reaktion (anafylaksi), bronkospasme eller akut lungesvigt (se pkt.
The infusion should be discontinued immediately and permanently if the patient experiences a NCICTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).
Perjeta administreres ved intravenøs infusion.
Perjeta is administered intravenously by infusion.
Ved administration sammen med Perjeta, kan dosis af docetaxel startes på 75 mg/m2 og efterfølgende optrappes til 100 mg/m2 afhængig af det valgte regime og tolerabilitet af den initiale dosis.
When administered with Perjeta, docetaxel can be started at 75 mg/m2, and subsequently escalated to 100 mg/m2 depending on the chosen regimen and tolerability of the initial dose.
Der blev givet standarddoser af 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamid, docetaxel, paclitaxel og carboplatin.
Standard doses of 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamide, docetaxel, paclitaxel and carboplatin were administered.
º Overfølsomhed/anafylaktisk reaktion består af en række bivirkninger inden for samme kategori.
° Hypersensitivity/anaphylactic reaction is based on a group of terms.
Patienterne blev randomiseret til at få én af tre følgende neoadjuverende behandlingsregimer inden operation:
Patients were randomised to receive one of three neoadjuvant regimens prior to surgery as follows:
Kontakt straks lægen eller sundhedspersonalet, hvis du oplever en eller flere af ovenstående bivirkninger.
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Efter fortynding indeholder 1 ml infusionsvæske ca. 3,02 mg pertuzumab for den initiale dosis og ca. 1,59 mg pertuzumab for vedligeholdelsesdosis (se pkt.
After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6).
I APHINITY-studiet forekom febril neutropeni hos 12,1% af de Perjeta-behandlede patienter og hos 11,1% af de placebo-behandlede patienter.
In the APHINITY trial, febrile neutropenia occurred in 12.1% of Perjeta-treated patients and 11.1% of placebo-treated patients.
I TRYPHAENA var hyppigheden af febril neutropeni højere hos patienter, som fik 6 serier Perjeta sammenlignet med patienter, der fik 3 serier Perjeta uafhængig af, hvilken kemoterapi, der var givet.
In TRYPHAENA, the incidence of febrile neutropenia was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given.
• Infusionsreaktioner med symptomer, som enten kan være lette eller svære og kan inkludere kvalme, feber, kulderystelser, træthed, hovedpine, appetitløshed, led- og muskelsmerter og hedeture.
Infusion reactions with symptoms that can either be mild or more severe and may include feeling sick (nausea), fever, chills, feeling tired, headache, loss of appetite, joint and muscle pains, and hot flushes.
Der kan opstå allergiske og anafylaktiske (mere alvorlige allergiske) reaktioner, når du får infusionen.
Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
I det pivotale studie CLEOPATRA med metastatisk brystkræft var incidensen af LVD under studiebehandling højere i placebo-gruppen end i Perjeta-gruppen (henholdsvis 8,6% og 6,6%).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the Perjeta-treated group (8.6% and 6.6%, respectively).
Der blev ikke observeret nogen bivirkninger hos seksuelt kønsmodne hun-cynomolgus aber, der havde fået pertuzumab (se pkt.
No adverse reactions were observed in sexually mature female cynomolgus monkeys exposed to pertuzumab (see section 5.3).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter fortynding Må ikke rystes
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution Do not shake
Derudover medierer pertuzumab antistofafhængig cellemedieret cytotoksicitet.
In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC).
Der blev rapporteret diarré grad ≥ 3 hos 9,8% af patienterne i Perjeta-armen vs. 3,7% i placebo-armen.
Grade ≥ 3 diarrhoea was reported in 9.8% of patients in the Perjeta arm vs. 3.7% in the placebo arm.
Ugentlig intravenøs administration af pertuzumab i doser på op til 150 mg/kg var generelt veltolereret hos cynomolgus-aber.
In cynomolgus monkeys, weekly intravenous administration of pertuzumab at doses up to 150 mg/kg/dose was generally well tolerated.
I tabel 2 inkluderes desuden bivirkninger indberettet efter markedsføring.
In addition, ADRs reported in the post-marketing setting are included in Table 2.
Fra toksicitetsstudier i cynomolgus aber med gentagen dosering, kan der ikke drages nogle endelige konklusioner om bivirkninger på hanners reproduktionssystem.
In repeated dose toxicity studies in cynomolgus monkeys, no definitive conclusions could be drawn on the adverse effect on male reproductive organs.
I samme studie blev initialdosis af Perjeta givet dagen før trastuzumab og docetaxel, så patienten kunne vurderes for Perjeta-relaterede reaktioner.
In the pivotal trial CLEOPATRA, the initial dose of Perjeta was given the day before trastuzumab and docetaxel to allow for the examination of Perjetaassociated reactions.
Docetaxel blev givet intravenøst med en initialdosis på 75 mg/m2 efterfulgt af 75 mg/m2 eller 100 mg/m2 (hvis tolereret) hver 3. uge.
Docetaxel was given intravenously at an initial dose of 75 mg/ m2 followed by 75 mg/ m2 or 100 mg/ m2 (if tolerated) every 3 weeks.
Det anbefales derfor, at patienten observeres omhyggeligt under den første infusion med Perjeta, og 60 minutter efter infusionen er afsluttet, samt under efterfølgende infusioner, og 30-60 minutter efter infusionen er afsluttet.
Close observation of the patient during and for 60 minutes after the first infusion and during and for 30-60 minutes after subsequent infusions of Perjeta is recommended.
Perifer neuropati Hovedpine Smagsforstyrrelser Perifer sensorisk neuropati Svimmelhed Paræstesier
Nervous system disorders Neuropathy peripheral Headache
Efter operation fik alle patienterne 3 serier bestående af 5fluoruracil (600 mg/m2), epirubicin (90 mg/m2) og cyclophosphamid (600 mg/m2) intravenøst med 3 uger intervaller samt trastuzumab intravenøst hver 3. uge for at fuldføre 1 års behandling.
Following surgery all patients received 3 cycles of 5fluorouracil (600 mg/m2), epirubicin (90 mg/m2), cyclophosphamide (600 mg/m2) (FEC) given intravenously every three weeks, and trastuzumab administered intravenously every three weeks to complete one year of therapy.
De mest almindelige bivirkninger (≥ 30%) i disse poolede data var diarré, alopeci, kvalme, træthed, neutropeni og opkastning.
The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue,
Paronykie Øvre luftvejsinfektion
Paronychia Upper respiratory tract infection
De hyppigste infusionsreaktioner (≥ 1,0%) i Perjetagruppen var pyreksi, kulderystelser, træthed, hovedpine, asteni, overfølsomhed og opkastning.
The most common infusion reactions (≥ 1.0%) in the Perjeta-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
• Øvrige indholdsstoffer: iseddikesyre, L-histidin, saccharose, polysorbat 20 og vand til injektionsvæsker.
The other ingredients are glacial acetic acid, L-histidine, sucrose, polysorbate 20 and water for injections
I de pivotale studier defineredes en infusionsreaktion som enhver bivirkning, der forekom under infusionen eller på infusionsdagen, og som blev rapporteret som overfølsomhed, anafylaktisk reaktion, akut infusionsreaktion eller cytokinfrigivelsessyndrom.
An infusion reaction was defined in the pivotal trials as any event reported as hypersensitivity, anaphylactic reaction, acute infusion reaction or cytokine release syndrome occurring during an infusion or on the same day as the infusion.
pCR-rate i brystet (ypT0/is)
pCR rate in the breast (ypT0/is)
Dog blev der i gruppen behandlet med Perjeta i kombination med docetaxel, carboplatin og trastuzumab givet 75 mg/m2 intravenøs docetaxel (optrapning ikke tilladt) og intravenøs carboplatin (AUC 6) hver 3. uge.
However, in the group treated with Perjeta in combination with TCH, docetaxel was given intravenously at 75 mg/m2 (no escalation was permitted) and carboplatin (AUC 6) was given intravenously every three weeks.
Sekundære effektendepunkter var invasiv sygdomsfri overlevelse inklusive anden primær kræft (ikke bryst), samlet overlevelse, sygdomsfri overlevelse, recidiv-frit interval samt fjernrecidiv-frit interval.
Secondary efficacy endpoints were IDFS including second primary non-breast cancer, overall survival (OS), disease-free survival (DFS), recurrence-free interval (RFI) and distant recurrence-free interval (DRFI).
Perjeta skal seponeres permanent i tilfælde af NCI-CTCAE grad 4 overfølsomhedsreaktioner (anafylaksi), bronkospasmer eller akut lungesvigt (se pkt.
Perjeta must be permanently discontinued in case of NCI-CTCAE Grade 4 hypersensitivity reactions (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.2).
Ca. halvdelen af patienterne i hver behandlingsgruppe havde østrogenreceptor-positiv og/eller progesteronreceptorpositiv sygdom.
Approximately half the patients in each treatment group had ER-positive and/or PgR-positive disease.
LISTE OVER HJÆLPESTOFFER Iseddikesyre, L-histidin, saccharose og polysorbat 20.
Glacial acetic acid, L-histidine, sucrose and polysorbate 20.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 420 mg/14 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 420 mg/14 ml
• Symptomer fra brystet, såsom tør hoste eller åndenød (kan være et tegn på interstitiel lungesygdom, der er en sygdom, hvor vævet omkring luftsækkende i lungerne er beskadiget)
Chest symptoms such as a dry cough or breathlessness (possible signs of interstitial lung disease, a condition of damage to the tissues around the air sacs in the lungs) Fluid around the lungs causing difficulty in breathing
Patienter med tidlig brystkræft
Patients with early breast cancer
5-fluoruracil (500 mg/m2), epirubicin (100 mg/m2) og cyclophosphamid (600 mg/m2) blev givet intravenøst hver 3. uge i 3 serier.
FEC (5-fluorouracil [500 mg/m2], epirubicin [100 mg/m2], cyclophosphamide [600 mg/m2]) were given intravenously every three weeks for 3 cycles.
Det er en klar til let opaliserende, farveløs til svagt gul væske.
It is a clear to slightly pearly (opalescent), colourless to pale yellow liquid.
Dosisreduktion af Perjeta og trastuzumab frarådes.
Dose reductions are not recommended for Perjeta or trastuzumab.
pCR-rate i brystet og lymfeknude (ypT0/is N0)
pCR rate in the breast and lymph node (ypT0/is N0)
• Brug ikke Perjeta efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the outer carton after EXP.
• Neoadjuverende behandling af voksne patienter med HER2-positiv, lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft med høj risiko for tilbagefald (se pkt.
• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
Antallet af invasiv sygdomsfri overlevelsestilfælde/Samlet antal (%)
Number of IDFS events/Total N (%)
Dysfunktion af venstre ventrikel
Left ventricular dysfunction
Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Other medicines and Perjeta Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Der sås ingen tegn på farmakokinetisk interaktion mellem pertuzumab og disse lægemidler.
There was no evidence of any PK interaction between pertuzumab and any of these agents.
Sådan får du Perjeta
How you are given Perjeta
• Vil du også få trastuzumab og kemoterapi
You will also be given trastuzumab and chemotherapy.
I Perjeta-armen svandt diarrésymptomerne til baseline niveau efter HER2-behandling.
Diarrhoea symptoms returned to baseline after HER2 therapy in the Perjetaarm.
I både TRYPHAENA- og APHINITY-studiet var den samlede frekvens af overfølsomhed/anafylaksi højest i gruppen behandlet med Perjeta og docetaxel, carboplatin og trastuzumab (henholdsvis 13,2% og 7,6%), hvoraf henholdsvis 2,6% og 1,3% af tilfældene var NCI-CTCAE grad 3-4.
In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4.
Ca. halvdelen af patienterne i hver behandlingsgruppe havde hormonreceptor-positiv sygdom (defineret som østrogenreceptor-positiv og/eller progesteronreceptor-positiv).
Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as ER positive and/or PgR positive).
Almindelige (kan påvirke op til 1 ud af 10 patienter):
Common (may affect up to 1 in 10 people):
I det pivotale studie CLEOPATRA oplevede størstedelen af patienterne i begge behandlingsgrupper mindst et tilfælde af leukopeni (63,0% i Perjeta-gruppen og 58,3% i placebo-gruppen), som i de fleste tilfælde var neutropeni (se pkt.
In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4).
Tilfælde af overfølsomhed/anafylaksi var sammenlignelige i de neoadjuverende og adjuverende studier og med dem observeret i CLEOPATRA.
In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA.
Distributionsvoluminet af det centrale og det perifere kompartment er i en typisk patient på henholdsvis 3,11 og 2,46 liter i alle kliniske studier.
Across all clinical studies, the volume of distribution of the central (Vc) and the peripheral (Vp) compartment in the typical patient, was 3.11 litres and 2.46 litres, respectively.
I det pivotale studie CLEOPATRA med metastatisk brystkræft var den samlede hyppighed af overfølsomhed/anafylaksi rapporteret af investigator under hele behandlingsperioden 9,3% i placebo gruppen og 11,3% i Perjeta-gruppen, hvoraf henholdsvis 2,5% og 2% var af NCI-CTCAE-grad 3-4.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the overall frequency of investigator reported hypersensitivity/anaphylaxis events during the entire treatment period was 9.3% in the placebo-treated group and 11.3% in the Perjeta-treated group, of which 2.5% and 2.0% were NCI-CTCAE Grade 3-4, respectively.
Figur 1 Uafhængigt vurderet progressionsfri overlevelse for hver patient-subgruppe
Figure 1 IRF-assessed PFS by patient subgroup
Lægen eller sygeplejersken vil holde øje med, om du får bivirkninger under infusionen og i 30 til 60 minutter efter, infusionen er afsluttet.
Your doctor or nurse will check for side effects during your infusion and for 30 to 60 minutes afterwards.
Randomisering var stratificeret efter typen af brystkræft (operabel, lokalt avanceret eller inflammatorisk) og østrogenreceptor-positivitet og/eller progesteronreceptor-positivitet.
Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER and /or PgR positivity.
Pertuzumab blev givet intravenøst med en initialdosis på 840 mg efterfulgt af 420 mg hver 3. uge.
Pertuzumab was given intravenously at an initial dose of 840 mg, followed by 420 mg every three weeks.
• Et LVEF på 40-45% i forbindelse med et fald på ≥ 10% point i forhold til værdien inden behandling.
• a drop in LVEF to less than 40% • a LVEF of 40%-45% associated with a fall of ≥ 10% points below pre-treatment value.
Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Infusionsvæsken bør administreres straks efter tilberedning (se pkt.
Once the infusion is prepared it should be administered immediately (see section 6.3).