natgillin/translations-raw huggingface dataset:
Asymptomatiske eller lette symptomatiske (NYHA klasse II) fald i LVEF på mindst 10% fra baseline og indtil < 50% blev indberettet hos 2,7% af de Perjeta-behandlede patienter og 2,8% af de placebo-behandlede patienter, hvoraf 79,7% af de Perjeta-behandlede patienter og 80,6% af de placebo-behandlede patienter var restitueret ved data cutoff.
declines in LVEF of at least 10% points from baseline and to <50% were reported in 2.7% of Perjetatreated patients and 2.8% of placebo-treated patients, of whom 79.7% of Perjeta-treated patients and
For eksempel doxorubicin eller epirubicin - denne type medicin kan skade hjertet og øge risikoen for, at du får hjerteproblemer med Perjeta.
If you have ever had a chemotherapy medicine from the class called anthracyclines, e.g. doxorubicin or epirubicin - these medicines can damage heart muscle and increase the risk of heart problems with Perjeta.
Sjælden (≥1/10.000 til <1/1.000)
Common (≥ 1/100 to < 1/10) Uncommon( ≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
APHINITY er et randomiseret, dobbelt-blindet, placebo-kontrolleret, fase III-multicenterstudie udført hos 4804 patienter med HER2-positiv tidlig brystkræft, som havde fået fjernet primærtumor inden randomisering.
APHINITY is a multicentre, randomised, double-blind, placebo-controlled Phase III trial conducted in 4804 patients with HER2-positive early breast cancer who had their primary tumour excised prior to randomisation.
I TRYPHAENA-studiet blev Perjeta administreret samtidigt med epirubicin, som en del af 5-fluorouracil, epirubicin, cyclophosphamid-regimet (se pkt.
In the TRYPHAENA study, Perjeta was given concurrently with epirubicin, as part of the FEC (5-fluorouracil, epirubicin, cyclophosphamide) regimen (see sections 4.8 and 5.1).
• Kræften ikke har spredt sig til andre dele af kroppen, og behandlingen vil blive givet før operation (behandling før operation kaldes neoadjuverende behandling)
The cancer has not spread to other parts of the body and treatment is going to be given before surgery takes place (treatment before surgery is called neoadjuvant therapy) The cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy)
Randomisering var stratificeret efter typen af brystkræft (operabel, lokalt avanceret eller inflammatorisk) og østrogenreceptor-positivitet eller progesteronreceptor-positivitet.
Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER or PgR positivity.
På det tidspunkt var det gennemsnitlige fald fra baseline i fysisk funktionsniveau -10,7 (95% konfidensinterval -11,4; -10,0) i Perjeta-armen og -10,6 (95% konfidensinterval -11,4; -9,9) i placebo-armen.
The mean decrease from baseline at that time for physical function was -10.7 (95% CI-11.4, -10.0) in the Perjeta arm and -10.6 (95% CI -11.4, -9.9) in the placebo arm; global health status was -11.2 (95% CI -12.2, -10.2) in the Perjeta arm and -10.2
Dosis af docetaxel kunne efter investigators skøn titreres op til 100 mg/m2, såfremt initialdosis var veltolereret.
The dose of docetaxel could be escalated to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Trastuzumab blev givet intravenøst med en initialdosis på 8 mg/kg efterfulgt af 6 mg/kg hver 3. uge.
Trastuzumab was given intravenously at an initial dose of 8 mg/kg, followed by 6 mg/kg every three weeks.
Lægen eller sundhedspersonalet vil holde øje med, om du får bivirkninger under infusionen og i 60 minutter efter, infusionen er afsluttet
Your doctor or nurse will check for side effects during your infusion and for 60 minutes afterwards.
Du skal bruge sikker prævention, mens du er i behandling med Perjeta og i 6 måneder efter, behandlingen er stoppet.
You should use effective contraception during treatment with Perjeta and for 6 months after stopping treatment.
I dette studie svarede den kardielle sikkerhed til den observeret hos patienter i samme regime, men med Perjeta administreret sekventielt (efter 5-fluorouracil, epirubicin, cyclophosphamidkemoterapi).
In this study, cardiac safety was similar to that observed in patients given the same regimen but with Perjeta administered sequentially (following FEC chemotherapy).
Placebo + trastuzumab + kemoterapi
Placebo + trastuzumab + chemotherapy
I NEOSPHERE oplevede 2 patienter i gruppen behandlet med Perjeta og docetaxel anafylaksi.
In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis.
I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom udslæt hos 51,7% i Perjetagruppen sammenlignet med 38,9% i placebo-gruppen.
In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients.
Docetaxel blev givet med en initialdosis på 75 mg/m2 som intravenøs infusion hver 3. uge med mulighed for at optrappe til 100 mg/m2 efter investigators skøn, hvis initialdosis var veltolereret.
Docetaxel was given as an initial dose of 75 mg/m2 IV infusion every three weeks with the option to escalate to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Hyppigheden af udslæt var højere hos patienter, der fik 6 serier Perjeta sammenlignet med patienter, der fik 3 serier Perjeta, uafhængig af hvilken kemoterapi, der var givet.
The incidence of rash was higher in patients who received six cycles of Perjeta compared with patients who received three cycles of Perjeta, independent of the chemotherapy given.
Perjeta 420 mg koncentrat til infusionsvæske, opløsning pertuzumab
Perjeta 420 mg concentrate for solution for infusion pertuzumab
Tidlig brystkræft
Early Breast Cancer
Perjeta er i kombination med trastuzumab og kemoterapi indiceret til:
Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy in:
Der er observeret svære overfølsomhedsreaktioner, herunder anafylaksi og tilfælde med dødeligt udfald,med Perjeta (se pkt.
Severe hypersensitivity, including anaphylaxis and events with a fatal outcome, has been observed with Perjeta (see section 4.8).
Sjældne (kan påvirke op til 1 ud af 100 patienter):
Uncommon (may affect up to 1 in 100 people):
Estimat af invasiv sygdomsfri overlevelse efter 4 år var 92,3% i den Perjeta-behandlede gruppe vs. 90,6% i den placebo-behandlede gruppe.
The estimate of IDFS at 4-years was 92.3% in the Perjeta-treated group versus 90.6% in the placebo treated group.
Hyppigheden af NCI-CTCAE grad 3-4 diarré var 9,3% i Perjeta-gruppen imod 5,1% i placebo-gruppen.
The incidence of NCI-CTCAE Grade 3-4 diarrhoea was 9.3% in Perjeta-treated patients vs 5.1% in placebo-treated patients.
Behandling med ilt, beta-agonister, antihistaminer, hurtig intravenøs væskebehandling og antipyretika kan også lindre symptomerne.
Treatment including oxygen, beta agonists, antihistamines, rapid i.v.
• Hjerteproblemer (hjertesvigt) med symptomer, som kan inkludere hoste, åndenød og hævede ben og arme (væske i kroppen).
Heart problems (heart failure) with symptoms that can include cough, shortness of breath, and swelling (fluid retention) in your legs or arms.
I 3 af disse 7 hændelser kunne en årsagssammenhæng mellem administration af pertuzumab og et dødeligt udfald ikke udelukkes.
In the remaining 7 cases the events reported were indeed suggestive of IRR/ hypersensitivity/ anaphylaxis and in 3/7 of them, a causal relationship between the administration of pertuzumab and the fatal event could not be excluded.
Anbefalet initiale startdosis af pertuzumab er 840 mg administreret som en 60 minutters intravenøs infusion, efterfulgt af en vedligeholdelsesdosis på 420 mg over 30 til 60 minutter hver 3. uge.
The recommended initial loading dose of pertuzumab is 840 mg administered as a 60 minute intravenous infusion, followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes.
Perjeta + trastuzumab + kemoterapi
Perjeta + trastuzumab + chemotherapy
Ustratificeret hazard ratio (95% konfidensinterval)
Unstratified HR (95% CI)
I det pivotale studie CLEOPATRA med metastatisk brystkræft var hyppigheden af NCI-CTCAE version 3 grad 3-4 neutropeni ensartet i de to behandlingsgrupper (86,3% i Perjeta-gruppen og 86,6% i placebo-gruppen, inklusive henholdsvis 60,7% og 64,8% grad 4 neutropeni).
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively).
6.2 og 6.6. for instruktioner om fortynding af Perjeta før administration.
For instructions on dilution of Perjeta prior to administration, see sections 6.2 and 6.6.
Du må ikke få Perjeta:
You must not be given Perjeta
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Perjeta 420 mg koncentrat til infusionsvæske, opløsning pertuzumab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Perjeta 420 mg concentrate for solution for infusion pertuzumab
BERENICE er et ikke-randomiseret, åbent, multicenter, multinationalt fase II-studie udført hos 401 patienter med HER2-positiv lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft (med primær tumorer > 2 cm i diameter eller lymfeknude-positiv).
BERENICE is a non-randomized, open-label, multicentre, multinational, Phase II trial conducted in 401 patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (with primary tumours > 2cm in diameter or node-positive disease).
• En intravenøs infusion med en initial startdosis af trastuzumab på 8 mg/kg kropsvægt,
• an IV infusion with an initial loading dose of trastuzumab 8 mg/kg body weight followed every 3 weeks thereafter by a maintenance dose of 6 mg/kg body weight or
Det anses for sandsynligt, at forskellen i pCR-raten kan overføres til en klinisk betydningsfuld forskel i langsigtede resultater, hvilket understøttes af positive tendenser for progressionsfri overlevelse (hazard ratio 0,69; 95% konfidensinterval 0,34;
The difference in pCR rate is considered likely to translate into a clinically meaningful difference in long term outcomes and is supported by positive trends in PFS (HR 0.69, 95% CI 0.34, 1.40) and DFS (HR 0.60, 95% CI 0.28, 1.27).
TRYPHAENA er et randomiseret klinisk fase II multicenterstudie udført hos 225 voksne kvinder med HER2-positiv, lokalt avanceret, operabel eller inflammatorisk brystkræft (T2-4d; primær tumor > 2 cm i diameter), som ikke tidligere havde fået trastuzumab, kemoterapi eller strålebehandling.
TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Behandling med Perjeta og trastuzumab skal afbrydes i mindst tre uger, hvis:
Perjeta and trastuzumab should be withheld for at least 3 weeks for:
Før samtidig anvendelse af Perjeta og et antracyklin skal kardielle risikofaktorer nøje overvejes og afbalanceres mod den medicinske nødvendighed hos den enkelte patient.
Cardiac risk should be carefully considered and balanced against the medical need of the individual patient before use of Perjeta with an anthracycline.
Den højeste forekomst af diarré (alle grader) blev rapporteret i behandlingsperioden med forsøgsbehandling + taxan-kemoterapi (61,4% af patienterne i Perjetaarmen vs. 33,8% af patienterne i placebo-armen).
The highest incidence of diarrhoea (all Grades) was reported during the targeted therapy+taxane chemotherapy period (61.4% of patients in the Perjeta arm vs. 33.8% of patients in the placebo arm).The incidence of diarrhoea was much lower after chemotherapy cessation, affecting
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at få Perjeta Sådan får du Perjeta
What Perjeta is and what it is used for What you need to know before you are given Perjeta How you are given Perjeta Possible side effects
Et 14 ml hætteglas med koncentrat indeholder 420 mg pertuzumab i en koncentration på 30 mg/ml.
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
• Meget svær eller vedvarende diarré (7 eller flere afføringer om dagen).
Tell a doctor or nurse straight away, if you notice any of the following side effects: Very severe or persistent diarrhoea (7 or more stools per day).
Af de patienter, der oplevede symptomatisk hjerteinsufficiens, var 46,7% af de Perjeta-behandlede patienter og 57,1% af de placebo-behandlede patienter restitueret (defineret som to på hinanden følgende LVEF-målinger over 50%) ved data cutoff.
of Perjeta-treated patients and 57.1% of placebo-treated patients had recovered (defined as 2
† Bivirkninger indberettet efter markedsføring.
† ADRs reported in the post marketing setting
Der er observeret infusionsreaktioner i forbindelse med brug af Perjeta, inklusive tilfælde med dødeligt udfald (se pkt.
Perjeta has been associated with infusion reactions, including events with a fatal outcome (see section 4.8).
4.2) hver 3. uge med start på dag 1 i den første taxan-holdige serie, i alt 52 uger (op til 18 serier) eller indtil recidiv, tilbagetrækning af informeret samtykke eller uacceptabel toksicitet.
Pertuzumab and trastuzumab were administered intravenously (see section 4.2) every 3 weeks starting on Day 1 of the first taxane-containing cycle, for a total of 52 weeks (up to 18 cycles) or until recurrence, withdrawal of consent or unmanageable toxicity.
Hvordan virker Perjeta?
How Perjeta works
I det pivotale studie CLEOPATRA med metastatisk brystkræft forekom diarré hos 68,4% i Perjetagruppen og hos 48,7% i placebo-gruppen (se pkt.
In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjetatreated patients and 48.7% of placebo-treated patients (see section 4.4).
Dysfunktion af venstre ventrikel **
Left ventricular dys function **
I APHINITY-studiet var hyppigheden af NCI-CTCAE (version 4) grad 3-4 neutropeni 40,6% hos patienter behandlet med Perjeta, trastuzumab og kemoterapi sammenlignet med 39,1% hos patienter behandlet med placebo, trastuzumab og kemoterapi, inklusive henholdsvis 28,3% og 26,5% grad 4 neutropeni.
In the APHINITY trial, the incidence of NCI-CTCAE v.4 Grade 3-4 neutropenia was 40.6% in patients treated with Perjeta, trastuzumab and chemotherapy compared with 39.1% in patients treated with placebo, trastuzumab and chemotherapy, including 28.3% and 26.5% Grade 4 neutropenia,
Der blev observeret høje pCR-rater i alle tre behandlingsarme (se tabel 4) sammenlignet med publicerede data for lignende behandlingsregimer uden pertuzumab.
Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
Clearance faldt hos patienter med høje albumin-koncentrationer ved baseline og steg hos patienter med høj kropsvægt.
Baseline albumin and lean body weight were the most significant covariates influencing CL. CL decreased in patients with higher baseline albumin concentrations and increased in patients with greater lean body weight.
Docetaxel blev givet som intravenøs infusion med en initialdosis på 75 mg/m2 hver 3. uge i mindst 6 serier.
Docetaxel was given as an initial dose of 75 mg/m2 as an intravenous infusion every three weeks for at least 6 cycles.
Hvert hætteglas indeholder i alt 420 mg pertuzumab i en koncentration på 30 mg/ml.
Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml
n (%)
n (%) [95% CI]
Demografien var velbalanceret imellem behandlingsarmene (median-alder 49-50 år, størstedelen var kaukasiere (77%)), og alle patienter var kvinder.
Demographics were well balanced between arms (median age was 49-50 years, the majority were
• Feber
Fever
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et 14 ml hætteglas indeholder 420 mg pertuzumab i en koncentration på 30 mg/ml.
STATEMENT OF ACTIVE SUBSTANCE(S) One 14 ml vial contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
I APHINITY-studiet oplevede 25,8% af patienterne i Perjeta-armen bivirkninger i form af udslæt vs. 20,3% af patienterne i placebo-armen.
In the APHINITY trial, the adverse event of rash occurred in 25.8% of patients in Perjeta arm vs. 20.3% of patients in placebo arm.
• Perjeta plus trastuzumab og docetaxel
• Perjeta plus trastuzumab and docetaxel
• Gruppe A - 4 serier af to ugentlige doxorubicin og cyclophosphamid (kemoterapi med kortere intervaller (dose-dense)) efterfulgt af 4 serier af Perjeta i kombination med trastuzumab og paclitaxel
• Cohort A - 4 cycles of two weekly dose-dense doxorubicin and cyclophosphamide followed by 4 cycles of Perjeta in combination with trastuzumab and paclitaxel.
Perjeta + trastuzumab + kemoterapi N=2400
Perjeta + trastuzumab + Chemotherapy N=2400
• Perjeta gives sammen med anden kræftmedicin (trastuzumab og kemoterapi).
Perjeta is given with other cancer treatments (trastuzumab andchemotherapy).
Resultaterne for progressionsfri overlevelse vurderet af investigator svarede til dem, der blev vist for den uafhængigt vurderede progressionsfrie overlevelse.
The results for investigator-assessed PFS were similar to those observed for IRF-assessed PFS.
I subgruppen med hormonreceptor-positiv sygdom, var invasiv sygdomsfri overlevelses-raten 94,8% vs. 94,4% efter 3 år og 93,0% vs. 91,6% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
In the hormone receptor-positive subgroup estimates of IDFS rates were 94.8% versus 94.4% at 3 years and 93.0% versus 91.6% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
En post-hoc eksplorativ analyse viste, at for patienter, der tidligere havde fået trastuzumab (n = 88), var hazard ratio for den uafhængigt vurderede progressionsfrie overlevelse 0,62 (95% konfidensinterval 0,35-1,07) sammenlignet med
A post hoc exploratory analysis revealed that for patients who had received prior trastuzumab (n = 88), the hazard ratio for IRF-assessed PFS was 0.62 (95% CI 0.35, 1.07), compared with 0.60 (95% CI 0.43, 0.83) for patients who had received prior therapy which did not include trastuzumab (n = 288).
Patienterne blev randomiseret til at få 4 serier af ét af følgende neoadjuverende behandlingsregimer inden operation:
Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery:
[95% KI] ypT0 N0
[95% CI]
Den estimerede invasiv sygdomsfri overlevelses-rate i subgruppen med lymfeknude-positiv sygdom var 92,0% vs. 90,2% efter 3 år og 89,9% vs. 86,7% efter 4 år hos henholdsvis Perjeta-behandlede patienter og placebo-behandlede patienter.
Estimates of IDFS rates in the lymph node- positive subgroup were 92.0% versus 90.2% at 3 years and 89.9% vs. 86.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively.
Perjeta + trastuzumab N=107
Perjeta+ Trastuzuma b N=107
Udover Perjeta vil du også få trastuzumab og kemoterapi.
You will also be given trastuzumab and chemotherapyl.
Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
IDFS= invasive disease free survival; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller sundhedspersonalet til råds, før du begynder behandlingen med Perjeta.
Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby.
I APHINITY-studiet blev der indberettet en højere forekomst af diarré i Perjeta-armen (71,2%) sammenlignet med placebo-armen (45,2%).
(71.2%) compared to the placebo arm (45.2%).
14 ml opløsning i et hætteglas (Type I glas) med prop (butylgummi).
Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution.
I APHINITY-studiet var forekomsten af symptomatisk hjerteinsufficiens (NYHA klasse III eller IV) med et fald i LVEF på mindst 10% fra baseline og indtil < 50%, på < 1% (0,6% af de Perjetabehandlede patienter vs. 0,3% af de placebo-behandlede patienter).
decline of at least 10% points from baseline and to <50% was <1% (0.6% of Perjeta-treated patients vs 0.3% of placebo-treated patients).
NEOSPHERE er et multinationalt, randomiseret, kontrolleret fase II-multicenterstudie med Perjeta, der blev gennemført med 417 voksne kvinder r med nyligt diagnosticeret tidlig inflammatorisk eller lokalt avanceret HER2-positiv brystkræft (T2-d4; primær tumor > 2 cm i diameter), der ikke tidligere havde fået trastuzumab, kemoterapi eller strålebehandling.
NEOSPHERE is a phase II, multicentre, multinational randomised controlled trial with Perjeta and was conducted in 417 adult female patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy.
Antal patienter med en hændelse Median antal måneder Objektiv responsrate^sekundært endepunkt Antal patienter med målbar sygdom
Objective Response Rate (ORR)^ - secondary endpoint no. of patients with measurable disease
Efter en median-opfølgning på 45,4 måneder, viste data fra APHINITY-studiet et fald på 19% (hazard ratio [HR] = 0,81; 95% konfidensinterval 0,66-1,00 p-værdi 0,0446) i risiko for recidiv eller død hos patienter randomiseret til at få Perjeta sammenlignet med patienter randomiseret til at få placebo.
0.81; 95% CI 0.66, 1.00 p-value 0.0446) reduction in risk of recurrence or death in patients randomised to receive Perjeta compared with patients randomised to receive placebo.
I NEOSPHERE-studiet forekom diarré hos 45,8% af patienterne behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel sammenlignet med 33,6% af patienterne behandlet med trastuzumab og docetaxel.
In the NEOSPHERE trial, diarrhoea occurred in 45.8% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 33.6% of patients treated with trastuzumab and docetaxel.
Derudover er der ikke set lægemiddelinteraktion mellem pertuzumab og trastuzumab eller mellem pertuzumab og docetaxel i den populationsfarmakokinetiske analyse.
In addition, in the population PK analysis, no evidence of a drug-drug interaction has been shown between pertuzumab and trastuzumab or between pertuzumab and docetaxel.
I NEOSPHERE oplevede 8,3% af de asiatiske patienter behandlet med neoadjuverende Perjeta, trastuzumab og docetaxel febril neutropeni sammenlignet med 4,0% af asiatiske patienter behandlet med neoadjuverende trastuzumab og docetaxel.
In NEOSPHERE, 8.3% of Asian patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 4.0% of Asian patients treated with neoadjuvant trastuzumab and docetaxel.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
Name and address of the manufacturer responsible for batch release Roche Pharma AG
Behandling med Perjeta og trastuzumab kan genoptages hvis LVEF forbedres til ≥ 50% eller til en forskel på <10% point i forhold til værdierne inden behandling.
Perjeta and trastuzumab may be resumed if the LVEF has recovered to ≥50% or to a difference of
Iseddikesyre L-histidin
Glacial acetic acid L-Histidine Sucrose
• 3 eller 4 serier af 5-fluoruracil, epirubicin og cyclophosphamid eller 5-fluorouracil, doxorubicin og cyclophosphamid efterfulgt at 3 eller 4 serier af docetaxel eller 12 serier af ugentlig paclitaxel
• 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Perifert ødem Pyreksi Træthed Asteni
Mucosal inflammation Oedema peripheral Pyrexia
Antal (%) patienter med hændelse
Number (%) of patients with event HR [95% CI]