natgillin/translations-raw huggingface dataset:
5.1 for yderligere oplysninger om human epidermal vækstfaktor receptor 2- (HER2) status.
For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af Avastin.
However, sleepiness and fainting have been reported with Avastin use.
Du kan blive rådet til at få foretaget et tandeftersyn, før du starter i behandling med Avastin.
You may be advised to have a dental check-up before you start treatment with Avastin.
Koncentratet er en klar, farveløs til lysebrun væske i et hætteglas af glas med gummilukke.
The concentrate is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med Avastin skal seponeres i tilfælde af intrakranial blødning.
Patients should be monitored for signs and symptoms of CNS bleeding, and Avastin treatment discontinued in cases of intracranial bleeding.
Hvis patienter oplever symptomer, som påvirker deres syn eller koncentration eller deres reaktionsevne, bør de frarådes at køre bil eller betjene maskiner indtil symptomerne aftager.
If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
I fleste tilfælde kan den nødvendige mængde Avastin blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (total volume).
In the majority of the occasions the necessary amount of Avastin can be diluted with 0.9 % sodium chloride solution for injection to a total volume of 100 mL.
Der er ikke foretaget studier for at evaluere Avastins carcinogene og mutagene potentiale.
Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Data fra disse patienter blev censored ved sidste tumorvurdering inden start af NPT.
was initiated prior to documented progression; data from those patients were censored at the last tumour assessment prior to starting NPT.
Der blev udført en ustratificeret analyse af PFS (vurderet af investigator), som ikke var censored for non-protokolleret terapi inden sygdomsprogression.
An unstratified analysis of PFS (investigator assessed) was performed that did not censor for nonprotocol therapy prior to disease progression.
• Avastin kan øge hyppigheden af forhøjet blodtryk.
● Avastin can increase the incidence of high blood pressure.
Administration af bevacizumab eller dets parenterale, murine antistof til nøgne mus i xenotransplantationsmodeller af kræft medførte omfattende anti-tumor aktivitet ved humane kræftformer, inklusive colon, mamma-, pancreas- og prostatakræft.
Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast, pancreas and prostate.
• lysglimt, som bevæger sig som ”flyvende fluer”, og som udvikler sig til tab af noget af synet,
• Seeing flashes of light with floaters, progressing to a loss of some of your vision,
En interim analyse viste, at der var signifikant forlængelse af tid til progression af sygdom for 10 mg/kg gruppen i forhold til placebogruppen (hazard ratio, 2,55; p < 0,001).
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Individuelle tilfælde og samling af tilfælde med alvorlige okulære bivirkninger er blevet rapporteret efter ikke-godkendt intravitreal anvendelse af Avastin i hætteglas godkendt til intravenøs administration til kræftpatienter.
Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin compounded from vials approved for intravenous administration in cancer patients.
• kortåndethed eller lavt indhold af ilt i blodet,
• shortness of breath or low levels of oxygen in the blood,
Resultaterne for effekt af Avastin i kombination med IFL-kemoterapi fremgår af tabel 4.
The efficacy results of Avastin in combination with IFL-chemotherapy are displayed in Table 4.
Nøgletal for effektresultater af superioritets-analysen (ITT Population, studie NO16966)
Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
I dette studie blev der observeret arterielle tromboemboliske bivirkninger hos 11 % (11/100) af patienterne i forhold til 5,8 % (6/104) i kemoterapikontrolgruppen.
In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Objektiv responsrate**
Objective Response Rate**
Det er ikke påvist, at Avastin nedsætter din evne til at køre bil eller betjene maskiner.
Avastin has not been shown to reduce your ability to drive or to use any tools or machines.
Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC07
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Af de patienter, der i løbet af studiet modtog studiebehandling, modtog 32,2 % (136/422) af patienterne 7-12 administrationer af Avastin, og 21,1 % (89/422) af patienterne modtog 13 eller flere administrationer af Avastin.
During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of Avastin and 21.1% (89/422) of patients received 13 or more administrations of Avastin.
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
● Periodic Safety Update Reports
Kombination af Avastin og disse behandlinger kan øge risikoen for alvorlige bivirkninger.
These therapies in combination with Avastin may increase the risk of severe side effects.
Det drejede sig for det meste om NCI-CTCAE v.3 grad 1 næseblod, som varede mindre end 5 minutter og ophørte uden behandling, og som ikke krævede ændringer i Avastinbehandlingen.
These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the Avastin treatment regimen.
De sekundære endepunkter inkluderede samlet overlevelse, responsrate, sygdomskontrolrate, responsvarighed og sikkerhed.
Secondary endpoints included overall survival, response rate, disease control rate, duration of response, and safety.
• hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer i Avastin (angivet i punkt 6).
● you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Der kan ikke drages konklusion vedrørende bevacizumabs påvirkning af gemcitabins farmakokinetik.
Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
Symptomerne kan inkludere vejrtrækningsbesvær eller brystsmerter.
The signs may include: difficulty in breathing or chest pain.
I et fase III-studie med adjuverende behandling hos patienter med coloncancer har et substudie med præmenopausale kvinder vist en højere hyppighed af nye tilfælde af ovariesvigt i bevacizumab-gruppen sammenlignet med kontrolgruppen.
In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group.
I begge studier var der en tendens til, at eksponeringen var lavere ved lavere legemsvægt.
In both studies, bevacizumb exposure trended lower as body weight decreased.
Dette er hovedsageligt blevet observeret i kombination med platin- eller taxanbaserede terapier i behandlingen af NSCLC, mBC og i kombination med paclitaxel og topotecan i behandlingen af persisterende, recidiverende eller metastatisk cervixcancer.
This has mainly been seen in combination with platinum- or taxane-based therapies in the treatment of NSCLC, mBC, and in combination with paclitaxel and topotecan in persistent, recurrent, or metastatic cervical cancer.
Patienternes medianalder var 61,0 år (spændevidde 25-84).
The median age of patients was 61.0 (range: 25−84) years.
• hvis du har problemer med sårheling efter en operation,
● if you have problems with wound healing following surgery,
Sikkerheden ved at genoptage behandlingen med Avastin hos patienter, der tidligere har udviklet PRES, er ikke kendt.
The safety of reinitiating Avastin therapy in patients previously experiencing PRES is not known.
Ved baseline havde de fleste patienter i begge behandlingsarme en GOG PS på 0 (CP: 82,4 %; CPB: 80,7 %) eller 1 (CP: 16,7 %; CPB: 18,1 %).
At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
ADMINISTRATIONSMETODE Til intravenøs anvendelse efter fortynding
METHOD OF ADMINISTRATION For intravenous use after dilution
Samlet set havde ca. 50 % af patienterne en GOGperformancestatus (PS)-score på 0 ved baseline, 43 % en GOG PS-score 1 og 7 % en GOG PS score på 2.
Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Yderligere endepunkter inkluderede objektivt respons, responsvarighed, samlet overlevelse og sikkerhed.
Additional endpoints included objective response, duration of response, overall survival and safety.
IRF vurdering
IRF assessment
Bevacizumab som tillæg til kombinationsstandardbehandlingen blev tolereret hos denne pædiatriske population
Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
For instruktion i fortynding af lægemidlet før administration, se pkt.
For instructions on dilution of the medicinal product before administration, see section 6.6.
Dag 1, før XELOX, hver 3. uge
Day 1, prior to XELOX, q 3 weeks
Indehaveren af markedsføringstilladelsen skal diskutere andre resultater for kombinationen bevacizumab + erlotinib for denne indikation (f.eks. data fra det igangværerende ACCRU-studie, NCT-nummer NCT01532089)
Due date the MAH should discuss any further outcome data on the combination of bevacizumab + erlotinib in this indication (e.g. data from the ongoing ACCRU study, NCT number NCT01532089) (due date: Q2 2019)
De fleste af patienterne i både CP-armen (80,4 %) og CPB-armen (78,9 %) var kaukasiere.
Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were White.
Det kliniske billede af PRES er ofte uspecifikt, og diagnosticeringen kræver derfor en bekræftelse ved en hjernescanning, helst magnetisk resonans- (MR) skanning.
The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Du vil få den fortyndede Avastinopløsning af en læge eller sygeplejerske ved intravenøs infusion (et drop i din vene).
A doctor or nurse will give you this diluted Avastin solution by intravenous infusion (a drip into your vein).
Samlet set var ca. 34 % af patienterne FIGO stadie III optimalt tumorreducerede med makroskopisk residualsygdom, 40 % stadie III sub-optimalt tumorreducerede, og 26 % var stadie IV-patienter.
Overall approximately 34% of patients were FIGO Stage III optimally debulked with gross residual disease, 40% Stage III sub-optimally debulked, and 26% were Stage IV patients.
Nekrotiserende fasciitisc
Necrotising fasciitisc
• taleforstyrrelser,
• changes in speech,
Strålebehandling Sikkerheden og effekten af samtidigt administreret strålebehandling og Avastin er ikke fastlagt.
The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.
Hvis du har fået for meget Avastin
If too much Avastin is given
• skader i tandkødet med en blotlagt kæbeknogle, der ikke heler; kan være forbundet med smerter og inflammation (betændelseslignende tilstand) i det omgivende væv (for yderligere anbefalinger se nedenfor efter bivirkningslisten),
• lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
aHazard ratio blev estimeret ud fra Cox proportionelle hazard modeller stratificeret efter varighed af platinfri periode før inklusion i studiet per eCRF (electronic case report form) og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
a Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No
Alvorlig eller massiv pulmonal blødning/hæmoptyse er observeret fortrinsvis i studier med patienter med ikke-småcellet lungekræft (NSCLC).
Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Der blev rapporteret grad 3 proteinuri hos op til 10,9 % af de behandlede patienter.
Grade 3 proteinuria was reported in up to 10.9% of treated patients.
I kliniske studier med Avastin blev kongestiv hjerteinsufficiens (CHF) observeret ved alle de kræftindikationer, som er undersøgt indtil videre, men forekom primært hos patienter med metastatisk brystkræft.
In clinical trials with Avastin, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
Patienter med ikke små-cellet lungekræft, som behandles med Avastin, kan have risiko for svære og i visse tilfælde dødelige pulmonale blødninger/hæmoptyse.
Patients with non-small cell lung cancer treated with Avastin may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Tilfælde af osteonekrose af kæben (ONJ) er blevet rapporteret hos patienter behandlet med Avastin, hvoraf de fleste tilfælde forekom hos patienter, der havde kendte risikofaktorer for ONJ, navnlig eksponering for intravenøse bisfosfonater og/eller en anamnese med tandsygdomme, som krævede invasive tandprocedurer (se også pkt.
Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with Avastin, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4)
Procentdelen af patienter, der fik åben behandling med Avastin, var 62,1 % i capecitabin + placebo-armen og 49,9 % i capecitabin + Avastin-armen.
The percentage of patients who received Avastin in the open-label phase was 62.1% in the capecitabine + placebo arm and 49.9% in the capecitabine + Avastin arm.
Tidsfrist
Schedule
• nedsat antal røde blodlegemer i blodet,
• decreased number of red cells in the blood,
Handelsnavnet og batchnummeret på det anvendte præparat skal registreres (eller anføres) tydeligt i patientens journal for at sikre sporbarheden af biologiske lægemidler.
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Alder havde ingen indvirkning på bevacizumabs farmakokinetik, når der blev taget hensyn til legemsvægt.
Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account.
Toksicitetsstudier på dyr med gentagne doser har vist, at bevacizumab kan have en ugunstig virkning på hunners fertilitet (se pkt.
Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see section 5.3).
Patienterne blev behandlet indtil progression af sygdommen.
Patients were treated until disease progression.
Den tilsvarende forekomst hos kontrolgruppen, som blev behandlet med kemoterapi alene, var henholdsvis 1,1% og 0,8%.
The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
I kliniske studier, med undtagelse af studie JO25567, var den totale hyppighed af hypertension (alle grader) på op til 42,1 % i Avastin-armene sammenlignet med en hyppighed på op til 14 % i kontrolarmene.
In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the Avastin containing arms compared with up to 14% in the control arms.
Dyrestudier har vist reproduktionstoksicitet, inklusive malformationer (se pkt.
Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Brug ikke Avastin, hvis du opdager partikler eller misfarvning før indgift.
Do not use Avastin if you notice any particulate matter or discolouration prior to administration.
Sekundære endepunkter
Secondary endpoints
• hul i skillevæggen mellem de to næsebor,
• a hole in the cartilage wall separating the nostrils of the nose,
Responsrater (for patienter med målbar sygdom)
Response rates (for patients with measurable disease)
Toksicitet og bivirkninger inkluderede arteriel hypertension og træthed samt CNS-iskæmi med akutte neurologiske udfald.
Toxicity and adverse reactions included arterial hypertension and fatigue as well as CNS ischaemia with acute neurological deficit.
En intra-abdominal inflammatorisk proces kan være en risikofaktor for gastrointestinal perforation hos patienter med metastatisk kolorektalkræft, og der skal derfor iagttages forsigtighed, når disse patienter behandles.
Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be exercised when treating these patients.
Der blev givet Avastin 10 mg/kg hver 2. uge indtil sygdomsprogession.
Avastin 10 mg/kg was given every 2 weeks until disease progression.
Trehalosedihydrat Natriumphosphat Polysorbat 20
Trehalose dihydrate Sodium phosphate Polysorbate 20
Tilføjelse af bevacizumab til fluoropyrimidin-baseret kemoterapi resulterede i statistisk signifikant forlænget overlevelse hos patienter med metastatisk kolorektalkræft, som progredierede på 1.linje bevacizumab-indeholdende regime (ITT = 819) (se tabel 9).
The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see Table 9).
Efter første behandlingsserie kan lægemidlet gives som en 1-times infusion.
1, the drug could be delivered as a 1-hour infusion.
• unormal urintest (protein i blodet),
• abnormal urine test (protein in the urine),
Effektdata fra studierne AVF0780g og AVF2192g, som undersøgte Avastin i kombination med 5-FU/FA-kemoterapi, er sammenfattet i tabel 5.
The efficacy data from trials AVF0780g and AVF2192g investigating Avastin in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
FOLFOX-4 eller XELOX + bevacizumab (n=699)
FOLFOX-4 or XELOX + bevacizumab (n=699)
Avastin bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft, når kræftcellerne har bestemte mutationer i et protein, der kaldes epidermal vækstfaktor-receptor (EGFR).
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Studiet mødte sit primære mål for forbedring af PFS.
The trial met its primary objective of PFS improvement.
Når bevacizumab først er bundet til VEGF, forhindres tumoren i at vokse, idet væksten af de blodkar, som forsyner tumoren med næringsstoffer og ilt, blokeres.
Once bevacizumab is bound to VEGF, tumour growth is prevented by blocking the growth of the blood vessels which provide the nutrients and oxygen to the tumour.
Det primære endepunkt var progressionfri overlevelse vurderet af investigator ved brug af modificeret RECIST 1.0.
The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Bevacizumabs farmakokinetik var lineær i dosisområdet 1 til 10 mg/kg.
The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Den nødvendige mængde bevacizumab skal udtages og fortyndes til det ønskede administrationsvolumen med natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/ml (0.9%) solution for injection.
Den kliniske gevinst, bedømt efter samlet overlevelse, blev set i alle forudspecificerede patientundergrupper, inklusive grupper defineret i henhold til alder, køn, performancestatus, lokalisering af primær tumor, antal involverede organer og varighed af metastatisk sygdom.
The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Kongestiv hjerteinsufficiens (CHF)
Congestive heart failure (CHF)
Bevacizumabs farmakokinetikblev evalueret hos 152 børn, unge og unge voksne (7 måneder til 21 år; 5,9 kg til 125 kg) på tværs af 4 kliniske studier ved hjælp af en populationsfarmakokinetisk model.
The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies using a population pharmacokinetic model.
3,7 % af den samlede randomiserede patientpopulation havde stadium III B-sygdom.
3.7% of the overall randomised patient population had Stage IIIB disease.
Patienter, som har fået adjuverende behandling indeholdende taxan eller antracyklin inden for de sidste 12 måneder, bør udelukkes fra behandling med Avastin i kombination med capecitabin.
Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine.
Avastin indeholder:
What Avastin contains
Der er dokumenteret kemisk og fysisk holdbarhed før anvendelsen i 48 timer ved 2 ºC til 30 ºC i natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection.
• Det er muligt, at Avastin kan øge risikoen for, at der dannes huller i tarmvæggen.
● It is possible that Avastin may increase the risk of developing holes in the gut wall.
Disse inkluderer: Nedsat antal hvide blodceller, specielt neutrofile (en type hvide blodceller, som hjælper mod infektioner), protein i urinen, nedsat kalium, nedsat natrium eller nedsat fosfor (mineral) i blodet, øget sukker i blodet, øget basisk fosfatase (et enzym) i blodet, forhøjet serum-kreatinin (et protein, som måles ved en blodprøve og bruges til at vurdere din nyrefunktion), nedsat hæmoglobin (findes i røde blodceller, og som transporterer ilt), som kan være alvorlig.
These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen),
• Det er muligt, at Avastin kan øge risikoen for blødning i lungerne, herunder blodig hoste eller spyt.
● It is possible that Avastin can increase the risk of bleeding in your lungs, including coughing or spitting blood.