natgillin/translations-raw huggingface dataset:
Bevacizumab-armene var bedre med hensyn til progressionsfri overlevelse i ITT (intentto-treat) populationen (tabel 7) i forhold til behandlingsarmene, der kun indeholdt kemoterapi.
• Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
Anvendelsesmåde og indgivelsesmåde
Method and route of administration
Den primære effektparameter var varighed af samlet overlevelse.
The primary efficacy variable of the trial was overall survival.
Disse bivirkninger inkluderer cerebrovaskulære tilfælde, myokardieinfarkt, transitorisk cerebral iskæmi og andre arterielle tromboemboliske bivirkninger.
An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Blod og lymfesystem Febril neutropeni, Leukopeni,
Febrile neutropenia, Leucopenia, Neutropenia a,
Du skal fortsætte med Zirabev, indtil Zirabev ikke længere hindrer tumoren i at vokse.
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Zirabev fails to stop your tumour growing.
1 hætteglas á 4 ml 100 mg/4 ml
1 vial of 16 ml 400 mg/16 ml
Øjengener, Tåreflåd
Eye disorder, Lacrimation increased
Studie BO17704 var et randomiseret dobbeltblindet fase III-studie med bevacizumab i kombination med cisplatin og gemcitabin, der blev sammenlignet med placebo, cisplatin og gemcitabin.
Trial BO17704 was a randomised, double-blind phase III trial of bevacizumab in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Tromboemboli (venøs)
Thrombo-embolism (venous)
Hypertensiv encefalopati
Hepatic impairment
● Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
● If you have any further questions, ask your doctor, pharmacist or nurse.
Osteonekrose af kæben a,b
Osteonecrosis of the jaw a,b
Ovariesvigt a,b
Foetal abnormalities a,b
Lungeemboli, Epistaxis, Dyspnø, Hypoksi hypertension c,
Pulmonary embolism, Hypoxia, Dysphonia a
Den progressionsfrie overlevelse og den objektive tumorresponsrate forøgedes signifikant ved tillæg af bevacizumab til IFN alfa-2a behandlingen.
The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Hvert hætteglas indeholder 100 mg bevacizumab.
Each vial contains 100 mg bevacizumab.
Zirabev bruges også i behandlingen af voksne patienter med vedvarende livmoderhalskræft, med livmoderhalskræft, som er kommet igen, eller med livmoderhalskræft, der har spredt sig (dannet metastaser).
Zirabev is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Hazard ratio var 0,93 (95 % konfidensinterval: 0,61-1,41; p-værdi = 0,72).
At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Antal patienter Progressionsfri overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
Number of patients Progression-free survival Median (months) Hazard ratio
Blødning b,d
Proteinuria b,d
Dette skal ses i sammenligning med < 1 % af de patienter, der kun fik kemoterapi (NCICTCAE v. 3).
Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Zirabev indeholder
Contents of the pack and other information What Zirabev contains
Samlet overlevelse - primær analyse
Overall survival - Primary analysis6 Median (months)
Cerebrovaskulære tilfælde (inklusiv transitorisk iskæmisk attak) blev rapporteret hos op til 2,7 % af patienterne, som fik bevacizumab i kombination med kemoterapi i forhold til op til 0,5 % af patienterne, som fik kemoterapi alene.
were reported in up to 2.7% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.5% of patients treated with chemotherapy alone.
Smerter, Letargi, Slimhindeinfla mmation
Pain, Lethargy, Mucosal inflammation
En stor del af patienterne (ca.
A high proportion of patients (approximately 63% IFN/placebo;
Hud og subkutane væv Sårhelingskomplik ationer b,d
Wound healing complications b,d
Nyrer og urinveje
pancreas and prostate.
Bækkensmerter
Succinic acid
Nasal septumperforati on
Nas al s eptum perforation a
Hætteglas (uåbnet)
6.3 Shelf life Vial (unopened)
De observerede ændringer var kun delvist reversible.
The observed changes were only partially reversible.
Ingen bedring i løbet af 7 dage eller 2. forekomst
No improvement within 7 days or 2nd occurrence
Stivarga bør tages på samme tidspunkt hver dag.
Stivarga should be taken at the same time each day.
• Gennemsnitlig alder: 63 år
• Median age: 63 years
Dato for første markedsføringstilladelse: 26. august 2013 Dato for seneste fornyelse: 22. maj 2018
Date of first authorisation: 26 August 2013 Date of latest renewal: 22 May 2018
Dette kan skyldes acceleration af en aldersrelateret fysiologisk proces.
This may be due to acceleration of an age-related physiological process.
Stivarga bør seponeres permanent, hvis der ikke er nogen resolution.
Stivarga should be permanently discontinued if there is no resolution.
Denne 4-ugers periode anses for at være en behandlingscyklus.
This 4-week period is considered a treatment cycle.
Miljørisikovurdering (Environmental Risk Assessment, ERA)
Environmental risk assessment (ERA)
Denne medicin kan også påvirke resultaterne af nogle blodprøver.
This medicine may also affect the results of some blood tests.
Din læge vil normalt bede dig tage Stivarga i 3 uger og dernæst stoppe i 1 uge.
Your doctor will usually ask you to take Stivarga for 3 weeks and then to stop for 1 week.
• Mand: 88 %
• Male: 88%
Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data)
Not known (frequency cannot be estimated from the available data)
Der blev også observeret en stigning i AUC for irinotecan på ca. 28 %.
An increase in AUC of irinotecan of approximately 28% was also observed.
Undgå at drikke grapefrugtjuice, mens du tager Stivarga.
Avoid drinking grapefruit juice while taking Stivarga.
Derefter skal lægemidlet bortskaffes.
Thereafter, the medicinal product is to be discarded.
De er klassificeret i henhold til organsystem og den mest hensigtsmæssige MedDRA-term anvendes til at beskrive en bestemt reaktion og dets synonymer og relaterede tilstande.
They are classified according to System Organ Class and the most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
En forud planlagt interimanalyse for virkning blev foretaget efter 432 dødsfald.
A pre-planned interim analysis for efficacy was performed when 432 deaths had occurred.
• Kaukasisk: 36 %, asiatisk: 41 %
• Caucasian: 36%, Asian: 41%
Din læge kan ændre din dosis.
Your doctor may change your dose.
Fortæl det straks til lægen, hvis du har nogle af følgende symptomer:
Tell your doctor immediately if you have any of the following symptoms:
Den samlede mediantid fra seneste progression eller recidiv til randomisering var 6 uger.
The overall median time since most recent progression or relapse to randomisation was 6 weeks.
Grad b Alle grader % Grad 3/4 % Alle grader % Grad 3/4 % Alle grader % Grad 3/4 %
Grade b All Grades % Grade 3/4 % All Grades % Grade 3/4 % All Grades % Grade 3/4 %
Dosisafbrydelser og/eller dosisreduktioner kan være påkrævet på baggrund af individuel sikkerhed og tolerans.
Dose interruptions and/or dose reductions may be required based on individual safety and tolerability.
Normalt skal du tage Stivarga, så længe du drager fordel deraf og ikke har uacceptable bivirkninger.
You will usually take Stivarga as long as you are benefiting and not suffering unacceptable side effects.
Tag Stivarga på samme tidspunkt hver dag efter et let (fedtfattigt) måltid.
Take Stivarga at the same time each day after a light (low-fat) meal.
Dette svarer til 3 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Derefter bør regelmæssig kontrol fortsættes mindst månedligt og efter klinisk behov.
Thereafter, periodic monitoring should be continued at least monthly and as clinically indicated.
Stivarga kan reducere fertiliteten hos både mænd og kvinder.
Stivarga may reduce fertility in both men and women.
Din læge kan midlertidigt stoppe din behandling.
Your doctor may temporarily stop your treatment.
• ECOG Performance Status (PS) på 0: 66 % eller ECOG PS på 1: 34 %
• ECOG Performance Status (PS) of 0: 66% or ECOG PS of 1: 34%
• Gennemsnitlig behandlingstid med sorafenib: 7,8 måneder
• Median duration of sorafenib treatment: 7.8 months
Fysiologi-baseret farmakokinetisk modellering forudsiger imidlertid ingen relevant ændring i eksponering hos disse patienter.
However, physiology-based pharmacokinetic modelling does not predict any relevant change in exposure in these patients.
Brug af Stivarga sammen med mad og drikke
Taking Stivarga with food and drink
Tag den dosis Stivarga, som din læge har ordineret til dig.
Take the dose of Stivarga that your doctor prescribes for you.
Administration Stivarga er til oral anvendelse.
Method of administration Stivarga is for oral use.
Det er 1 behandlingscyklus.
This is 1 cycle of treatment.
Farmakokinetiske interaktioner med andre antibiotika er ikke undersøgt.
Pharmacokinetic interactions of other antibiotics have not been studied.
- Hvis du får brystsmerter eller har hjerteproblemer.
- if you get chest pain or have any heart problems.
Randomiseringen blev foretaget inden for 10 uger efter den sidste behandling med sorafenib.
Randomisation was performed within 10 weeks after the last treatment with sorafenib.
Disse hændelser vides også at være almindelige sygdomsrelaterede komplikationer hos patienter med intraabdominale maligniteter.
These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
• Radioterapi inden regorafenib-behandling: 15 %
• Radiotherapy prior to regorafenib treatment: 15%
Du bør ikke tage Stivarga sammen med grapefrugtjuice (se også punkt Brug af Stivarga sammen med mad og drikke).
You should not take Stivarga together with grapefruit juice (see also section ‘Taking Stivarga with food and drink').
De fleste patienter (52 %) fik 3 eller færre tidligere behandlingslinjer for metastaserende sygdom.
Most patients (52%) received 3 or fewer previous lines of treatment for metastatic disease.
Stivarga bør ikke anvendes under graviditeten, medmindre det tydeligvist er nødvendigt og efter omhyggelig overvejelse af fordelene for moderen og risikoen for fosteret.
Stivarga should not be used during pregnancy unless clearly necessary and after careful consideration of the benefits for the mother and the risk to the foetus.
Du skal muligvis behandles for det, og der kan udføres ekstra test (se også punkt 4, Bivirkninger)
You may need treatment for them and extra tests may be done (see also section 4 ‘Possible side effects').
Din læge vil tale med dig om de potentielle risici ved at tage Stivarga under graviditeten.
Your doctor will discuss with you the potential risks of taking Stivarga during pregnancy.
Den mediane sekundære PFS (målt efter investigatorens bedømmelse) var hhv. 5,0 og 4,5 måneder.
The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Øget INR*
Increased INR*
Tolerancen af Stivarga er ikke fastsat hos disse patienter.
The tolerability of Stivarga in these patients has not been established.
Laboratorieparameter (i % af undersøgte prøver)
Laboratory parameter, (in % of samples investigated)
Det anbefales derfor at overvåge patienten nøje for tegn og symptomer på øget eksponering for BCRP-substrater.
Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates.
Der er ikke udført specifikke fertilitets studier.
Specific studies on fertility have not been performed.
Hyppighedsgrupper defineres som følger: Meget almindelig (> 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000) og Ikke kendt (kan ikke estimeres ud fra de forhåndenværende data)
Frequency groups are defined by the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and not known (cannot be estimated from the available data).
Beslutningen om at genstarte behandlingen med Stivarga bør være baseret på nøje overvejelse af de potentielle fordele og risici for den enkelte patient.
The decision to re-start Stivarga therapy should be based on careful consideration of the potential benefits and risks of the individual patient.
Graviditet, amning og frugtbarhed Fortæl det til din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, da Stivarga ikke bør bruges under graviditeten, medmindre det tydeligvis er nødvendigt.
Pregnancy, breast-feeding and fertility Tell your doctor if you think you are pregnant, may be pregnant or plan on becoming pregnant as Stivarga should not be used during pregnancy unless clearly necessary.
Udskillelse af glucuronider i urinen faldt under 10 % under steady state-betingelser.
Urinary excretion of glucuronides decreased below 10% under steady-state conditions.
• Loco-regional transarterial embolisering eller kemoinfusionsprocedurer: 61 %
• Loco-regional transarterial embolisation or chemoinfusion procedures: 61%
P-værdi (ensidet)
P-value (one-sided)
Der er ingen data for anvendelse af regorafenib til gravide kvinder.
There are no data on the use of regorafenib in pregnant women.
Samlet udviklede ca. 4,6 % af patienterne i behandling med Stivarga hypotyroidisme, der krævede hormonsubstitutionsbehandling.
Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
Ældre Alder påvirkede ikke regorafenibs farmakokinetik i det undersøgte aldersområde (29-85 år).
Elderly Age did not affect the regorafenib pharmacokinetics over the studied age range (29 - 85 years).
Der er begrænsede data for patienter med PS ≥ 2.
There is limited data in patients with PS ≥2.
Det er et lægemiddel, der bruges til at behandle kræft ved at hæmme kræftcellernes vækst og spredningen af kræftceller og afskære den blodforsyning, der gør at cellerne kan vokse.
It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Der er ingen specifik antidot mod en Stivarga overdosis.
There is no specific antidote for Stivarga overdose.
Der er begrænsede data om regorafenib hos den negroide patientpopulation.
There is limited data on regorafenib in the black patient population.
Eksponeringen for regorafenib af forskellige asiatiske populationer (kinesisk, japansk, koreansk) ligger inden for det samme område som hos kaukasere.
The exposure of regorafenib in various Asian populations (Chinese, Japanese, Korean) is within the same range as seen in Caucasians.
Du kan få brug for lægehjælp, og din læge kan bede dig holde op med at tage Stivarga.
You may require medical attention and your doctor may tell you to stop taking Stivarga.
Fortæl det straks til lægen, hvis du har taget mere end den ordinerede dosis.
Tell your doctor immediately if you have taken more than your prescribed dose.
Regorafenib udskilles hovedsageligt via leveren, og eksponeringen kan være øget hos denne patientpopulation.
Regorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
• Fravær af både makroskopisk vaskulær invasion og ekstrahepatisk tumorspredning: 19 %
• Absence of both macroscopic vascular invasion and extra-hepatic tumour spread: 19%
Din læge vil eventuelt reducere din dosis eller beslutte at afbryde eller stoppe behandlingen permanent, hvis det er nødvendigt.
Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary.
Den kliniske signifikans af disse potentielle interaktioner er ukendt, men kan resultere i en nedsat virkning af regorafenib.
The clinical significance of these potential interactions is unknown, but may result in a decreased efficacy of regorafenib.
Undgå at blive gravid, mens du behandles med Stivarga, da dette lægemiddel kan skade det ufødte barn.
Avoid becoming pregnant while being treated with Stivarga, as this medicine may harm your unborn baby.
Patienter med performance status (PS) 2 eller derover var ekskluderet fra kliniske studier.
Patients with performance status (PS) 2 or higher were excluded from clinical studies.
Forstyrrelserne er generelt af mild til moderat sværhedsgrad, ikke associeret med kliniske manifestationer og kræver sædvanligvis ingen dosisafbrydelser eller dosisreduktioner.
The abnormalities are generally of mild to moderate severity, not associated with clinical manifestations, and do not usually require dose interruptions or reductions.
• Barcelona Clinic leverkræft (BCLC) stadie B: 13 %; BCLC stadie C: 87 %
• Barcelona Clinic Liver Cancer (BCLC) stage B: 13%; BCLC stage C: 87%
UGT1A1- og UGT1A9-substrater
UGT1A1 and UGT1A9 substrates
Inden indledning af behandling med Stivarga bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
Before initiating Stivarga, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Analyse af det primære endepunkt for virkning, progressionsfri overlevelse (PFS) blev udført efter 144 PFS-hændelser (central blindet bedømmelse).
The analysis of the primary efficacy endpoint Progression-Free Survival (PFS) was conducted after 144 PFS events (central blinded assessment).
Før ikke motorkøretøj og betjen ikke værktøj eller maskiner, hvis du oplever behandlingsrelaterede symptomer, der påvirker din koncentrations- og reaktionsevne.
Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Der foreligger ingen data om virkningen af Stivarga på menneskets fertilitet.
There are no data on the effect of Stivarga on human fertility.
In vitro-proteinbinding af regorafenib til humane plasmaproteiner er høj (99,5 %).
In vitro protein binding of regorafenib to human plasma proteins is high (99.5%).
Det primære endepunkt for virkning var OS.
The primary efficacy endpoint was OS.
Din læge vil kontrollere dit blodtryk før og under behandlingen og kan give dig et lægemiddel til behandling af højt blodtryk.
Your doctor will monitor your blood pressure prior to and during treatment and may give you a medicine to treat high blood pressure.
Hvis du får denne bivirkning, vil din læge eventuelt ændre din dosis eller standse din behandling, indtil din tilstand forbedres.
If you get this side effect, your doctor may change your dose or stop your treatment until your condition improves.
Der er identificeret to større og seks mindre metabolitter af regorafenib i plasma.
Two major and six minor metabolites of regorafenib have been identified in plasma.
Sekundære endepunkter, herunder tid til progression (TTP) og samlet overlevelse (OS) (interimanalyse), blev også bedømt.
Secondary endpoints including Time To Progression (TTP) and Overall Survival (OS (interim analysis) were also assessed.
Grad a
Grade a
Der er ikke udført studier af regorafenibs karcinogene potentiale.
Studies on the carcinogenic potential of regorafenib have not been performed.
De asiatiske patienter, der blev behandlet med Stivarga i kliniske studier, var primært fra Østasien (~90 %).
The Asian patients treated with Stivarga in clinical studies were primarily from East Asia (~90%).
Metabolit M-5 er et svagt BCRP-substrat.
Metabolite M-5 is a weak BCRP-substrate.
Ud af disse hændelser er 35,6 % af hændelserne i Stivarga-armen og 54,5 % i placeboarmen blevet rapporteret som ikke helbredt/ikke afklaret.
Of these events, 35.6% in the Stivarga arm and 54.5% in the placebo arm have been reported as not recovered/not resolved.
Et tilfælde af grad 4 hypertension blev rapporteret i GIST-studiet.
One case of Grade 4 hypertension was reported in the GIST trial.
Ændringer af tænder og knogler samt negative virkninger på reproduktionssystemet var mere udtalt hos unge og ikke udvoksede dyr samt hos juvenile rotter og indikerer en potentiel risiko for børn og unge.
Alterations of teeth and bones and adverse effects in the reproductive system were more pronounced in young and growing animals as well as in juvenile rats and indicate a potential risk for children and adolescents.
Hvis du har glemt at tage Stivarga
If you forget to take Stivarga
Det anbefales at tage leverfunktionsprøver (ALAT, ASAT og bilirubin) inden behandlingen med Stivarga indledes og kontrollere nøje (mindst hver anden uge) i løbet af de første 2 måneder af behandlingen.
It is recommended to perform liver function tests (ALT, AST and bilirubin) before initiation of treatment with Stivarga and monitor closely (at least every two weeks) during the first 2 months of treatment.
Den gennemsnitlige halveringstid for metabolitten M-5 er ca. 60 timer (ligger mellem 40-100 timer).
The mean elimination half-life for the metabolite M-5 is approximately 60 hours (range from 40 to 100 hours).
Dette lægemiddel kan udgøre en potentiel risiko for miljøet (se pkt.
This medicinal product may pose a risk to the environment (see section 5.3).
Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Sikkerhedsprofilen for Stivarga plus BSC i CONCUR-studiet var sammenlignelig med sikkerhedsprofilen i CORRECTstudiet.
The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
0,005178 6,4 måneder
0.005178 6.4 months
PS ≥2 blev rapporteret under behandling med Stivarga hos 11,4 % af patienterne.
PS ≥2 was reported during Stivarga treatment in 11.4% of patients.
Procent
Percentages
Karakteristika af demografi og sygdomsniveau var sammenlignelige mellem de Stivarga- og placebobehandlede grupper og er vist her under for alle 573 randomiserede patienter:
Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all 573 randomised patients:
Andre bivirkninger med Stivarga opstillet efter hyppighed:
Other side effects with Stivarga listed by frequency:
Der blev ikke observeret nogen QTc-forlængelse efter administration af 160 mg regorafenib ved steady state i et dedikeret QT-studie hos mandlige og kvindelige cancerpatienter.
No QTc prolonging effects were observed after administration of 160 mg regorafenib at steady state in a dedicated QT study in male and female cancer patients.
Nedsat appetit og fødeindtagelse
Decreased appetite and food intake
I tilfælde af mistanke om overdosis skal Stivarga omgående seponeres, med den bedste understøttende behandling, som skal indledes af en læge, og patienten skal observeres indtil klinisk stabilisering.
In the event of suspected overdose, Stivarga should be discontinued immediately, with best supportive care initiated by a medical professional, and the patient should be observed until clinical stabilisation.