natgillin/translations-raw huggingface dataset:
Data tilgængelig vedrørende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed med dødeligt udfald for patienter behandlet med Perjeta i kliniske studier, publicerede data og relevante data fra Roche's globale sikkerhedsdatabase viste ingen bekræftede sager vedrørende infusionsrelaterede reaktioner og anafylaksi/overfølsomhed med dødeligt udfald i de afsluttende kliniske studier hos patienter behandlet med pertuzumab.
Data available for Infusion Related Reactions (IRR) and anaphylaxis/hypersensitivity with fatal outcome for patients treated with Perjeta in clinical trials, data from published literature, and relevant data from the Roche global safety database showed that there were no cases of confirmed IRRs or anaphylaxis/hypersensitivity with a fatal outcome in pivotal clinical trials in patients treated with pertuzumab.
Som adjuverende behandling skal Perjeta administreres i kombination med trastuzumab i ialt ét år (op til 18 serier eller indtil sygdomsrecidiv eller uacceptabel toksicitet, afhængigt af hvad der opstår først), som led i et komplet behandlingsregime for tidlig brystkræft og uanset operationstidspunkt.
In the adjuvant setting, Perjeta should be administered in combination with trastuzumab for a total of one year (up to 18 cycles or until disease recurrence, or unmanageable toxicity, whichever occurs first) as part of a complete regimen for early breast cancer and regardless of the timing of surgery.
Intravenøs administration af pertuzumab fra gestationsdag 19 til og med gestationsdag 50 (perioden for organogenese) var embryotoksisk med en dosisafhængig stigning i embryoføtale dødsfald mellem gestationsdag 25 og 70.
Intravenous administration of pertuzumab from GD19 through GD50 (period of organogenesis) was embryotoxic, with dose-dependent increases in embryo-foetal death between GD25 to GD70.
Øget tåresekretion
Lacrimation increased
Behandling med Perjeta + trastuzumab + docetaxel og Perjeta + trastuzumab er sammenlignet med trastuzumab + docetaxel, mens Perjeta + docetaxel er sammenlignet med Perjeta + trastuzumab + docetaxel.
Treatment Perjeta+Trastuzumab+Docetaxel and Perjeta+Trastuzumab are compared to Trastuzumab+ Docetaxel while Perjeta+Docetaxel is compared to Perjeta+Trastuzumab+Docetaxel.
Sekundære virkningsendepunkter var samlet overlevelse, progressionsfri overlevelse (vurderet af investigator), objektiv responsrate, varighed af respons samt tid til symptomprogression vurderet i henhold til FACT B spørgeskemaet om livskvalitet.
Secondary efficacy endpoints were overall survival (OS), PFS (investigator-assessed), objective response rate (ORR), duration of response, and time to symptom progression according to the FACT B Quality of Life questionnaire.
HER2-overekspression blev bestemt på centralt laboratorium og defineret som en score på 3+ ved IHC- eller ISH-amplifikationsratio ≥ 2,0 i nedenfor beskrevne studier.
HER2 overexpression was determined at a central laboratory and defined as a score of 3+ by IHC or an ISH amplification ratio ≥2.0 in the trials outlined below.
I overensstemmelse med reduktion i føtal vækst blev der yderligere, sekundært til oligohydramnios, også noteret lungehypoplasi (1 af 6 i 30 mg/kg og 1 af 2 i 100 mg/kg gruppen), ventrikel-septum-defekt (1 af 6 i 30 mg/kg gruppen), tynd ventrikelvæg (1 af 2 i 100 mg/kg gruppen) og mindre skeletale misdannelser (eksterne - 3 af 6 i 30 mg/kg gruppen).
In addition, consistent with foetal growth restrictions, secondary to oligohydramnios, lung hypoplasia (1 of 6 in 30 mg/kg and 1 of 2 in100 mg/kg groups), ventricular septal defects (1 of 6 in 30 mg/kg group), thin ventricular wall (1 of 2 in 100 mg/kg group) and minor skeletal defects (external - 3 of 6 in 30 mg/kg group) were also noted.
Dosisjustering er ikke nødvendig hos patienter ≥ 65 år.
No dose adjustment is necessary in the elderly population ≥ 65 years of age.
De fleste tilfælde var lette til moderate i sværhedsgrad og forekom i de første få behandlingsserier.
Most events were mild to moderate in severity and occurred in the first few cycles of treatment.
Der var god respons på proaktiv behandling med midler mod diarré.
Diarrhoeal events responded well to proactive management with anti-diarrhoeal agents.
• NEOSPHERE (n=309) og TRYPHAENA (n=218), hvor neoadjuverende Perjeta blev givet i kombination med trastuzumab og kemoterapi til patienter med med lokalt avanceret eller inflammatorisk brystkræft eller tidlig brystkræft.
• NEOSPHERE (n=309) and TRYPHAENA (n=218), in which neoadjuvant Perjeta was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory, or early breast cancer
95% konfidensinterval for binomial fordeling for en prøve (one sample binomial) beregnet efter PearsonClopper-metoden.
95% CI for one sample binomial using Pearson-Clopper method.
I den adjuverende behandling, baseret på data fra APHINITY-studiet, er patienter med HER2-positiv tidlig brystkræft med høj risiko for tilbagefald defineret som dem med lymfeknude-positiv eller hormonreceptor-negativ sygdom.
In the adjuvant setting, based on data from the APHINITY study, HER2-positive early breast cancer patients at high risk of recurrence are defined as those with lymph node-positive or hormone receptornegative disease.
Der er ikke set nogen farmakokinetiske interaktioner mellem pertuzumab og trastuzumab eller mellem pertuzumab og docetaxel i et sub-studie med 37 patienter i det randomiserede pivotale studie CLEOPATRA med metastatisk brystkræft.
No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer.
Forekomst af symptomatisk systolisk dysfunktion af venstre ventrikel (LVD [kongestiv hjerteinsufficiens]) var højere blandt patienter behandlet med Perjeta i kombination med trastuzumab og kemoterapi sammenlignet med trastuzumab og kemoterapi.
The incidence of symptomatic left ventricular systolic dysfunction (LVD) [congestive heart failure] was higher in patients treated with Perjeta in combination with trastuzumab and chemotherapy compared with trastuzumab and chemotherapy .
Ved administration sammen med Perjeta som adjuverende behandling, er den anbefalede dosis af paclitaxel 80 mg/m2 en gang om ugen i 12 ugentlige serier.
When administered with Perjeta in the adjuvant setting, the recommended dose of paclitaxel is 80 mg/m2 once weekly for 12 weekly cycles.
Diarréen blev behandlet (med undtagelse af aflivning i et tilfælde, 50 mg/kg/dosis) med støttende behandling inklusive intravenøs væskesubstitution.
The diarrhoea was managed (with the exception of euthanasia of one animal, 50 mg/kg/dose) with supportive care including intravenous fluid replacement therapy.
Meget almindelige (kan påvirke flere end 1 ud af 10 patienter):
Very common (may affect more than 1 in 10 people):
Alternativt, kan en dosis af docetaxel på 100 mg/m2 gives i en 3-ugers serie fra starten af, igen afhængig af det valgte regime.
Alternatively, docetaxel can be given at 100 mg/m2 on a 3 weekly schedule from the start, again depending on the chosen regimen.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS-ETIKET
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Perjeta i kombination med trastuzumab og docetaxel CLEOPATRA (WO20698) er et multicenter, randomiseret, dobbeltblindet, placebo-kontrolleret, klinisk fase III-studie med 808 patienter med HER2-positiv, metastatisk eller lokalt recidiverende, ikke-resecerbar brystkræft.
Perjeta in combination with trastuzumab and docetaxel CLEOPATRA (WO20698) is a multicentre, randomised, double-blind, placebo-controlled phase III clinical trial conducted in 808 patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
pCR-raterne var sammenlignelige mellem patienter med operabel versus lokalt avanceret sygdom.
pCR rates were similar in patients with operable versus locally advanced disease.
• LVEF falder til mindre end 50% i forbindelse med et fald på ≥ 10% point i forhold til værdierne inden behandling.
• a drop in LVEF to less than 50% associated with a fall of ≥ 10% points below pre-treatment values.
Perjetas virkning ved HER2-positiv brystkræft understøttes af et randomiseret fase III-studie og et enkeltarmet fase II-studie med metastatisk brystkræft, to randomiserede neoadjuverende fase II-studier med tidlig brystkræft (ét kontrolleret), et ikke-randomiseret neoadjuverende fase II-studie samt et adjuverende randomiseret fase III-studie.
The efficacy of Perjeta in HER2-positive breast cancer is supported by a randomised phase III trial and a single-arm phase II trial in metastatic breast cancer, two randomised neoadjuvant phase II trials in early breast cancer (one controlled), a non-randomised neoadjuvant phase II trial, and a randomised phase III trial in the adjuvant setting.
Sekventielt brug af Perjeta (i kombination med trastuzumab og et taxan) er i APHINITY- og i BERENICE-studiet undersøgt efter administration af epirubicin- eller doxorubicin-komponenten i flere antracyklin-baserede regimer.
Sequential use of Perjeta (in combination with trastuzumab and a taxane) has been evaluated following the epirubicin or doxorubicin component of many anthracycline-based regimens in the APHINITY and BERENICE studies.
Patienterne blev randomiseret i forholdet 1:1 til placebo + trastuzumab + docetaxel eller Perjeta + trastuzumab + docetaxel.
Patients were randomised 1:1 to receive placebo + trastuzumab + docetaxel or Perjeta + trastuzumab + docetaxel.
Forekomsten af embryoføtalt tab var 33, 50 og 85% for drægtige hun-aber behandlet med doser på henholdsvis 10, 30 og 100 mg/kg pertuzumab to gange om ugen (2,5 til 20 gange større end de anbefalede humane doser baseret på Cmax).
The incidences of embryo-foetal loss were 33, 50, and 85% for pregnant female monkeys treated with bi-weekly pertuzumab doses of 10, 30, and 100 mg/kg, respectively (2.5 to 20-fold greater than the recommended human dose, based on Cmax).
Perjetas sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion.
The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment.
Der blev observeret en statistisk signifikant forbedring i pCR-raten (ypT0/is) hos patienter, der fik Perjeta plus trastuzumab og docetaxel sammenlignet med patienter, der fik trastuzumab og docetaxel (45,8% vs. 29,0%, p = 0,0141).
A statistically significant improvement in pCR rate (ypT0/is) was observed in patients receiving Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel (45.8% vs 29.0%, p value = 0.0141).
• Kræften har spredt sig til andre dele af kroppen, for eksempel lungerne eller leveren (dannet metastaser) og ikke tidligere er behandlet med kræftmedicin (kemoterapi) eller anden medicin designet til at binde sig til HER2, eller hvis kræften er kommet tilbage til brystet efter tidligere behandling.
The cancer has spread to other parts of the body such as the lungs or liver (metastasised) and has not previously been treated with anticancer medicines (chemotherapy) or other medicines designed to attach to HER2, or else the cancer has come back in the breast after previous treatment.
3,3% (13/389 patienter) i Perjeta-gruppen og 6,7% (25/372 patienter) i placebo-gruppen var positive for anti-terapeutiske antistoffer.
3.3% (13/389 patients) of Perjeta-treated patients and 6.7% (25/372 patients) of placebo-treated patients tested positive for ADA.
Hvis du får en infusionsreaktion, en allergisk eller anafylaktisk reaktion, skal du vente med at køre bil og betjene maskiner, indtil den er forsvundet.
However, if you get any infusion reactions, allergic or anaphylactic reactions, wait until these have gone away before driving or using machines.
Perjetas sikkerhed var generelt konsistent på tværs af studier, dog varierede hyppighed og de mest almindelige bivirkninger afhængigt af, om Perjeta blev administreret som monoterapi eller i kombination med antineoplastiske midler.
The safety of Perjeta was generally consistent across studies, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether Perjeta was administered as monotherapy or with concomitant anti-neoplastic agents.
• Få 420 mg Perjeta i løbet af 30 til 60 minutter.
You will be given 420 mg of Perjeta over 30 to 60 minutes.
Den gennemsnitlige varighed af den længste episode var 18 dage i Perjeta-gruppen og 8 dage i placebo-gruppen.
The median duration of the longest episode was 18 days in Perjeta-treated patients and 8 days in placebotreated patients.
Effektresultaterne fra CLEOPATRA-studiet er vist i tabel 3.
The efficacy results from the CLEOPATRA study are summarised in Table 3.
• Allergiske og anafylaktiske (mere alvorlige allergiske) reaktioner med symptomer, som kan inkludere hævelser i ansigtet og svælget, der gør det svært at trække vejret.
Allergic and anaphylactic (more severe allergic) reactions with symptoms that may include swelling of your face and throat, with difficulty in breathing.
• Ondt i halsen, rød, øm eller løbende næse, influenza lignende symptomer og feber
Sore throat, red, sore or runny nose, flu-like symptoms and fever Producing more tears
Demografien var velbalanceret (median-alder 49-50 år, størstedelen var kaukasiere (71%)) og alle patienter var kvinder.
Demographics were well balanced (median age was 49-50 years, the majority were caucasian (71%))
Invasiv sygdomsfri overlevelse inklusive anden primær kræft (ikke bryst)
IDFS including second primary non-breast cancer
ADMINISTRATIONSMETODE Til intravenøs anvendelse efter fortynding.
METHOD OF ADMINISTRATION For intravenous use after dilution
Patienter i det pivotale studie CLEOPATRA blev på flere tidspunkter testet for anti-terapeutiske antistoffer mod Perjeta.
Patients in the pivotal trial CLEOPATRA were tested at multiple time-points for anti-drug antibodies (ADA) to Perjeta.
Klinisk respons repræsenteret af patienter, hvor bedste samlede respons var komplet respons eller partielt respons i den neoadjuverende behandlingsperiode (i den primære brystlæsion).
Clinical response represents patients with a best overall response of CR or PR during the neoadjuvant period (in the primary breast lesion).
• Negleproblemer
Nail problems
Den fulde instruktion for udførelse af testen og tolkning af resultaterne findes i vejledningerne til de validerede HER2-test.
For full instructions on assay performance and interpretation please refer to the package leaflets of validated HER2 testing assays.
Pertuzumabs farmakokinetiske resultater fra NEOSPHERE- og APHINITY-studiet var i overensstemmelse med det forventede ud fra den tidligere populationsfarmakokinetiske model.
The PK results of pertuzumab in the NEOSPHERE and APHINITY studies were consistent with the predictions from the previous population PK model.
Herefter forbedredes scorer for såvel fysisk funktionsniveau som overordnet helbredsstatus til baseline niveau under forsøgsbehandlingen.
Thereafter in both arms physical function and global health status scores returned to baseline levels during targeted treatment.
Indenfor hver frekvenskategori og systemorganklasse er bivirkningerne præsenteret efter faldende alvorlighedsgrad.
Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.
• Du skal straks kontakte lægen, hvis du bliver gravid under behandlingen med Perjeta eller inden for 6 måneder efter, behandlingen er afsluttet.
Tell your doctor straight away, if you get pregnant during treatment with Perjeta or during the 6 months after stopping treatment.
I BERENICE var 4,1% (16/392) af patienterne i Perjeta-gruppen positive for anti-terapeutiske antistoffer.
In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
Tabel 2: Resumé af bivirkninger hos patienter behandlet med Perjeta i kliniske forsøg^, samt efter markedsføring†
Table 2 Summary of ADRs in patients treated with Perjeta in clinical trials^, and in the Postmarketing setting†
En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Ved kejsersnit på gestationsdag 100 blev der identificeret oligohydramnios, nedsat relativ lunge- og nyrevægt og mikroskopiverificeret bevis på renal hypoplasi konsistent med forsinket renal udvikling hos alle grupper behandlet med pertuzumab.
At Caesarean section on GD100, oligohydramnios, decreased relative lung and kidney weights and microscopic evidence of renal hypoplasia consistent with delayed renal development were identified in all pertuzumab dose groups.
Der er ikke gennemført specifikke studier med pertuzumab for at vurdere påvirkningen af fertilitet hos dyr.
No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab.
Hvis du vil vide mere om doseringen af trastuzumab og kemoterapi (som også kan give bivirkninger), kan du læse indlægssedlerne for disse præparater.
For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package leaflet for these products.
Såvel pCR-raten som størrelsesordenen af fordelen ved Perjeta (Perjeta plus trastuzumab og docetaxel sammenlignet med trastuzumab og docetaxel) var lavere i undergruppen af patienter med hormonreceptor-positive tumorer (forskel på 6% i pCR i brystet) end hos patienter med hormonrecetor-negative tumorer (forskel på 26,4% i pCR i brystet).
The pCR rates as well as the magnitude of benefit with Perjeta (Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel) were lower in the subgroup of patients with hormone receptor-positive tumours (difference of 6% in pCR in the breast) than in patients with hormone receptor-negative tumours (difference of 26.4% in pCR in the breast).
De fleste tilfælde af symptomatisk hjerteinsufficiens rapporteret blandt patienter, der fik Perjeta som adjuverende behandling, var hos patienter, der fik antracyklin-baseret kemoterapi (se pkt.
The majority of cases of symptomatic heart failure reported in the adjuvant setting were in patients who received anthracyclinebased chemotherapy (see section 4.8).
Der blev ikke observeret nogen sammenhæng mellem eksponeringen af pertuzumab og kreatininclearance i intervallet 27 til 244 ml/min.
No relationship between CLcr and pertuzumab exposure was observed over the range of CLcr (27 to 244 ml/min).
Hos patienter i antracyklin-baseret regime, skal Perjeta og trastuzumab administreres efter hele antracyklin-regimet er afsluttet (se pkt.
In patients receiving an anthracycline-based regimen, Perjeta and trastuzumab should be administered following completion of the entire anthracycline regimen (see section 4.4).
Ialt oplevede 2 patienter i placebo-gruppen og 4 patienter i Perjeta-gruppen bivirkninger, som af investigatorerne blev beskrevet som anafylaksi (se pkt.
Overall, 2 patients in the placebo-treated group and 4 patients in the Perjeta-treated group experienced events described as anaphylaxis by the investigator (see section
Efter fortynding skal 1 ml infusionsvæske indeholde ca. 3,02 mg pertuzumab (840 mg/278 ml) for initialdosis, hvor to hætteglas er påkrævet og ca. 1,59 mg (420 mg/264 ml) for vedligeholdelsesdosis, hvor et hætteglas er påkrævet.
After dilution, one ml of solution should contain approximately 3.02 mg of pertuzumab (840 mg/278 ml) for the initial dose where two vials are required and approximately 1.59 mg of pertuzumab (420 mg/264 ml) for the maintenance dose where one vial is required.
• Adjuverende behandling af voksne patienter med HER2-positiv tidlig brystkræft med høj risiko for tilbagefald (se pkt.
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Perjeta findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Ca. halvdelen af patienterne i hver behandlingsgruppe havde hormonreceptor-positiv sygdom (defineret som østrogenreceptor-positiv og/eller progesteronreceptor-positiv), og ca. halvdelen af patienterne i hver behandlingsgruppe havde tidligere fået adjuverende eller neoadjuverende behandling.
Approximately half the patients in each treatment group had hormone receptor-positive disease (defined as oestrogen receptor (ER) positive and/or progesterone receptor (PgR) positive) and approximately half of the patients in each treatment group had received prior adjuvant or neoadjuvant therapy.
Patienter, behandlet med Perjeta, trastuzumab og docetaxel, har højere risiko for at få febril neutropeni sammenlignet med patienter, behandlet med placebo, trastuzumab og docetaxel, især under de første 3 behandlingsserier (se pkt.
Patients treated with Perjeta, trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment (see section 4.8).
En statistisk signifikant forbedring i den progressionsfrie overlevelse, vurderet af den uafhængige komite, blev påvist i Perjeta-gruppen sammenlignet med placebo-gruppen.
A statistically significant improvement in IRF-assessed PFS was demonstrated in the Perjeta-treated group compared with the placebo-treated group.
• APHINITY, hvor adjuverende Perjeta blev givet i kombination med trastuzumab og antracyklinbaseret eller ikke-antracyklin-baseret, taxan-holdig kemoterapi til patienter med tidlig brystkræft(n=2364)
• APHINITY, in which adjuvant Perjeta was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n=2364)
Et multicenter, åbent, enkeltarms-studie med pertuzumab i kombination med trastuzumab og et taxan i første-linje-behandling af patienter med HER2-positiv avanceret (metastatisk eller lokalt recidiverende) brystkræft.
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
Incidensen af symptomatisk LVD var også lavere i Perjeta-gruppen (1,8% i placebo-gruppen vs.1,5% i Perjeta-gruppen) (se pkt.
The incidence of symptomatic LVD was also lower in the Perjeta-treated group (1.8% in the placebo-treated group vs. 1.5% in the Perjeta-treated group) (see section 4.4).
Som i CLEOPATRA-studiet var den observerede hyppighed af neutropeni og febril neutropeni højere blandt asiatiske patienter sammenlignet med andre patienter i begge neoadjuverende studier.
As in the CLEOPATRA trial, a higher incidence of neutropenia and febrile neutropenia was observed among Asian patients compared with other patients in both neoadjuvant trials.
• Hævede ankler eller andre kropsdele på grund af for meget væske i kroppen
Swollen ankles or other body parts due to your body retaining too much water Not being able to sleep
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Perjeta i alle undergrupper af den pædiatriske population med brystkræft i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Perjeta in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Der blev observeret et tilfælde af symptomatisk LVD i Perjeta plus trastuzumabgruppen.
There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group.