natgillin/translations-raw huggingface dataset:
Ud fra et mikrobiologisk synspunkt skal produktet anvendes øjeblikkeligt.
From a microbiological point of view, the product should be used immediately.
Disse resultater er blevet bekræftet ved en uafhængig radiologisk gennemgang.
These results have been confirmed through an independent radiological review.
En uafhængig gennemgang af det primære endepunkt blev også udført.
In addition, an independent review of the primary endpoint was also conducted.
Systemorganklasse (SOC)
System organ class (SOC)
Du vil blive behandlet med Zirabev én gang hver 2. eller 3. uge.
You will be treated with Zirabev once every 2 or 3 weeks.
* Hvis frekvens angives, er den udledt af data fra kliniske studier
* if specified, the frequency has been derived from clinical trial data
Der var ingen komplette respons og 2 delvise respons (Macdonald-kriterier).
There were no complete responses and 2 partial responses (MacDonald criteria).
I alt blev 452 patienter randomiseret til at få enten:
A total of 452 patients were randomised to receive either:
* primær analyse
* primary analysis
● Din læge skal angive handelsnavnet og batchnummeret på din medicin.
● Your doctor should record the brand name and batch number of your medication.
Det betyder ikke at disse bivirkninger nødvendigvis kun skyldes bevacizumab.
This does not necessarily mean that these side effects were strictly caused by bevacizumab.
Hvis det ikke anvendes straks, er opbevaringstiden ogbetingelserne under brug brugerens ansvar og bør normalt ikke overstige 24 timer ved 2 °C - 8 °C, medmindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
a patienter med målbar sygdom ved baseline
a patients with measurable disease at baseline
*Samlet overlevelsesanalyse ved klinisk cut-off 31. januar 2007 ** Primær analyse ved klinisk cut-off 31. januar 2006 I forhold til kontrolarmen
*Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Objektiv responsrate (ORR) Patienter inkluderet i analysen Rate
Objective response rate (ORR) Patients included in analysis Rate
Hvis Zirabev injiceres direkte i øjet (ikke-godkendt brug), kan følgende bivirkninger forekomme:
When Zirabev is injected directly into the eye (unapproved use), the following side effects may occur:
● Du kan få svær migræne.
● you may develop a severe migraine.
Hvis du skal opereres, hvis du har fået foretaget en større operation indenfor de sidste 28 dage, eller hvis du har et sår efter en operation, som ikke er helet, må du ikke få denne medicin.
If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Kun observeret i den pædiatriske population
Observed in pediatric population only
Disse klinisk signifikante bivirkninger er derfor inkluderet i Tabel 2 under kolonnen ”Frekvens ikke kendt”.
These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Bevacizumab vs. ingen Bevacizumab
Bevacizumab vs. No Bevacizumab
Bivirkninger, som er opsummeret i dette afsnit, er delt ind i følgende frekvenskategorier: 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), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The adverse reactions listed in this section fall into the following frequency categories: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Termerne repræsenterer grupperede bivirkninger, der beskriver et medicinsk koncept frem for en enkelttilstand eller den foretrukne term i MedDRA (Medical Dictionary for Regulatory Activities).
Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Tidligere hormonbehandling af metastatisk sygdom var tilladt.
Prior hormonal therapy for the treatment of metastatic disease was allowed.
Tabel 6 Behandlingsregimer i studie NO16966 (mCRC)
Table 6 Treatment regimens in trial NO16966 (mCRC)
Ældre patienter: Dosisjustering er ikke nødvendig hos ældre.
Elderly patients No dose adjustment is required in the elderly.
Zirabev kan også forårsage ændringer i de laboratorieundersøgelser, som din læge foretager.
Zirabev may also cause changes in laboratory tests carried out by your doctor.
intravenøs bolusinjektion umiddelbart efter leucovorin
intravenous bolus injection immediately after leucovorin
Alvorlige bivirkninger med ikke kendt hyppighed (kan ikke estimeres ud fra forhåndenværende data) omfatter:
Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
● hvis du får svært forhøjet blodtryk, der kræver behandling med blodtryksmedicin,
● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Almindelig Ikke almindelig Sjælden Meget sjælden Frekvens ikke kendt
Common Uncommon Rare Very rare Frequency not known
Zirabev kan skade det ufødte barn, da det kan standse dannelsen af nye blodkar.
Zirabev may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Generelt er lavt albumin og høj tumorbyrde indikativ for sygdommens sværhedsgrad.
Low albumin and high tumour burden are generally indicative of disease severity.
Den samlede gennemsnitsalder var 59,4 år, 56,6 % af patienterne havde en ECOG-performancestatus på 0, 43 % havde en status på 1 og 0,4 % havde en status på 2.
The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
● hvis du skal opereres.
● if you undergo surgery.
Hvis du har forhøjet blodtryk, som ikke er velbehandlet med blodtrykssænkende medicin, skal du kontakte din læge, fordi det er vigtigt at sikre, at dit blodtryk er under kontrol, før du starter i behandling med Zirabev.
If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Zirabev treatment.
Som forud planlagt blev inklusionen i arm 3 standset, så snart sikkerheden af bevacizumab med IFL-regimet var dokumenteret og blev anset for acceptabel.
Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
● Denne medicin kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier).
● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
● En sjælden neurologisk bivirkning kaldet posteriort reversibelt encefalopati- syndrom (PRES) har været knyttet til bevacizumabbehandling.
● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with bevacizumab treatment.
● Risikoen for at udvikle blodpropper i arterierne (en type blodkar) kan øges, hvis du er over 65 år, hvis du har sukkersyge, eller hvis du tidligere har haft blodpropper i arterierne.
● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Zirabev er udelukkende til engangsbrug, da produktet ikke indeholder konserveringsmidler.
Zirabev is for single-use only, as the product contains no preservatives.
I alle kliniske studier blev bevacizumab administreret som en intravenøs infusion.
In all clinical trials, bevacizumab was administered as an intravenous infusion.
Fortæl straks din læge, hvis du er gravid, bliver gravid under behandling med denne medicin eller har planer om at blive gravid.
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Du bør tale med din læge om det.
You should discuss this with your doctor.
Før du får Zirabev, eller imens du bliver behandlet med Zirabev:
Before you are given Zirabev or while you are being treated with Zirabev:
Bedste samlede respons - primær analyse
Best overall response - Primary analysis
Der skal iagttages forsigtighed, når disse patienter behandles med Zirabev.
Caution should be taken when treating these patients with Zirabev.
● Din læge beslutter, hvornår du skal have den næste dosis Zirabev.
● your doctor will decide when you should be given your next dose of Zirabev.
Patienter med nylig pulmonal blødning/hæmoptyse (> 2,5 ml rødt blod) bør ikke behandles med Zirabev.
Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Fremstiller Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Blandt de 110 patienter randomiseret til arm 3 (5-FU/FA + bevacizumab) inden lukning af denne arm, var den mediane samlede overlevelse 18,3 måneder og den mediane progressionsfri overlevelse var 8,8 måneder.
Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression free survival was 8.8 months.
Nasal septumperforation (ikke kendt) Pulmonal hypertension (ikke kendt) Dysfoni (almindelig)
Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Der bør udvises forsigtighed, når Zirabev og intravenøse bisfosfonater administreres samtidigt eller sekventielt.
Caution should be exercised when Zirabev and intravenous bisphosphonates are administered simultaneously or sequentially.
Stop ikke behandlingen med Zirabev før, du har diskuteret det med din læge.
Do not stop treatment with Zirabev unless you have discussed this with your doctor.
Vurdering af bevacizumabs metabolisme hos kaniner efter en intravenøs enkeltdosis af
Assessment of bevacizumab metabolism in rabbits following a single intravenous dose of
Dosis af Zirabev afhænger af din legemsvægt og af den type kræft, der skal behandles.
The dose of Zirabev needed depends on your body weight and the kind of cancer to be treated.
● svært forhøjet blodtryk, som ikke kan kontrolleres med blodtrykssænkende medicin, eller hvis blodtrykket pludseligt stiger alvorligt,
● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
● Denne medicin kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk.
● This medicine increases the risk of having protein in your urine especially if you already have high blood pressure.
Inden indledning af behandling med Zirabev bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
Before initiating Zirabev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Zirabev indeholder det aktive stof bevacizumab, som er et humaniseret monoklonalt antistof (et slags protein, som normalt laves af immunsystemet, og som hjælper med at beskytte kroppen mod infektioner og kræft).
Zirabev contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
● hvis du behøver invasiv tandbehandling (fx tandudtrækning) eller en tandoperation, skal du fortælle din tandlæge, at du er i behandling med Zirabev, især hvis du også bliver eller er blevet behandlet med bisfosfonater, som injektion i blodet.
● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Zirabev, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse Followup-analyse blev udført ved data cut-off 7. marts 2014; alle p-værdier er kun vist for oplysende formål
Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only
*Bevacizumab er et rekombinant humaniseret monoklonalt antistof, som fremstilles ved dna-teknologi i ovarieceller fra kinesiske hamstere.
*Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Din læge vil ordinere den dosis Zirabev, som passer til dig.
Your doctor will prescribe a dose of Zirabev that is right for you.
● Denne medicin kan forårsage blødning, især tumor-relateret blødning.
● This medicine may cause bleeding, especially tumour-related bleeding.
Infusionsvæsker med Zirabev bør ikke administreres eller blandes med glucoseopløsninger.
Zirabev infusions should not be administered or mixed with glucose solutions.
Det frarådes at anvende Zirabev til børn og unge under 18 år, da sikkerheden og fordelene ved Zirabev ikke er fastlagt hos denne patientgruppe.
Zirabev use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Der blev rapporteret dødelig udgang i ca. en tredjedel af de alvorlige tilfælde af gastrointestinal perforation, hvilket svarer til 0,2-1 % af alle bevacizumabbehandlede patienter.
Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab treated patients.
Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Zirabev:
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Zirabev:
Bevacizumab blev kombineret med to kemoterapiregimer:
bevacizumab was combined with two chemotherapy regimens:
Natriumhydroxid (til justering af pH-værdien) Vand til injektionsvæsker
Sodium hydroxide (for pH adjustment) Water for injections
Patienterne blev behandlet indtil sygdomsprogression.
Patients were treated until disease progression.
Forskel i responsrater
Difference in response rates
Fistler er også rapporteret efter markedsføring.
Fistulae have also been reported in post-marketing experience.
I de fleste af de kliniske studier med bevacizumab blev patienter med præ-eksisterende CHF af NYHA (New York Heart Association) klasse II-IV ekskluderet, og derfor findes der ingen data for risikoen for CHF i denne population.
In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Der er ikke observeret uforligeligheder mellem Zirabev og polyvinylchlorid- eller polyolefinposer.
No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Der er evidens for, at alle grader af proteinuri (US National Cancer Institute-Common Terminology Criteria for Adverse Event [NCI-CTCAE v.3]) kan være relateret til dosis.
There is evidence suggesting that all Grade (US National Cancer Institute- Common Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Zirabev skal seponeres permanent, hvis en klinisk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med standard antihypertensionsbehandling, eller hvis patienten udvikler hypertensiv krise eller hypertensiv encefalopati.
Zirabev should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Resultaterne for den primære analyse og followup-analysen er præsenteret for bevacizumabbehandling og forsøgsbehandling i henholdsvis tabel 14 og 15.
Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
● Zirabev kan øge risikoen for at udvikle et svagt hjerte.
● Zirabev can increase the risk of developing a weak heart.
● svær blødning.
● any severe bleeding.
Virkningsresultaterne af bevacizumab i kombination med IFL-kemoterapi fremgår af tabel 4.
The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in Table 4.
Dosisreduktion af IFN alfa-2a syntes ikke at påvirke effekten af kombinationen af bevacizumab og IFN alfa-2a, baseret på antal hændelser i tidsrummet for progressionsfri overlevelse, som er vist ved en undergruppeanalyse.
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of bevacizumab and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
I bevacizumab-armen kunne patienter få bevacizumab som enkeltstofbehandling hver 3. uge indtil sygdomsprogression eller indtil uacceptabel toksicitet.
In the bevacizumab-containing arms, patients could receive bevacizumab as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
En stor del af patienterne (omkring 62 %) fik derefter forskellige anticancerbehandlinger uden for protokollen, hvilket kan have haft indflydelse på den samlede overlevelse.
A high proportion of patients (approximately 62%) went on to receive a variety of nonprotocol specified anti- cancer therapies, which may have impacted the analysis of overall survival.
Afhængig af den dosis, som er foreskrevet til dig, vil en del af indholdet i hætteglasset med Zirabev eller hele indholdet blive fortyndet med natriumchloridopløsning (saltvandsopløsning) før anvendelsen.
Depending on the dose prescribed for you, some or all of the contents of the Zirabev vial will be diluted with sodium chloride solution before use.
Din læge bør vejlede dig om anvendelsen af prævention under behandlingen med Zirabev og i mindst 6 måneder efter sidste dosis Zirabev.
Your doctor should advise you about using contraception during treatment with Zirabev and for at least 6 months after the last dose of Zirabev.
● Det er muligt, at Zirabev kan forårsage blødning i og omkring hjernen.
● It is possible that Zirabev may cause bleeding in and around your brain.
● hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
● if you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Zirabev skal administreres under supervision af en læge med erfaring i anvendelse af antineoplastiske lægemidler.
Zirabev must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Tabel 7 Nøgletal for virkningsresultater af superioritets-analysen (ITT Population, studie NO16966)
Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Zirabev er et biosimilært lægemiddel.
Zirabev is a biosimilar medicinal product.
5.1 for yderligere oplysninger om human epidermal vækstfaktorreceptor 2 (HER2)-status.
For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Zirabev bør seponeres hos patienter, der udvikler nekrotiserende fasciitis og relevant behandling straks påbegyndes.
Zirabev therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
● Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
● If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Der blev givet bevacizumab 10 mg/kg hver 2. uge indtil sygdomsprogression.
Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Bevacizumab er ikke godkendt til anvendelse hos patienter under 18 år.
Bevacizumab is not approved for use in patients under the age of 18 years.
Ibevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgGmolekyle, som ikke binder VEGF.
I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01X C07
Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
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 bevacizumabbehandlingen.
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 bevacizumab treatment regimen.
Tillæg af bevacizumab til IFL resulterede i en statistisk signifikant stigning i den samlede overlevelse (overall survival) (OS), progressionsfri overlevelse (PFS) og samlet responsrate (se tabel 4).
The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
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.
Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med Zirabev skal seponeres i tilfælde af intrakranial blødning.
Patients should be monitored for signs and symptoms of CNS bleeding, and Zirabev treatment discontinued in cases of intracranial bleeding.
Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af bevacizumab.
However, sleepiness and fainting have been reported with bevacizumab use.
● Denne medicin kan øge risikoen for blødning eller problemer med sårhelingen efter operation.
● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Efter korrektion for legemsvægt havde mandlige patienter en højere bevacizumab-clearance (+ 17 %) i forhold til kvindelige patienter.
After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Zirabev er ikke formuleret til intravitreal anvendelse.
Intravitreal use Zirabev is not formulated for intravitreal use.
Vaskulære sygdomme Renal trombotisk mikroangiopati, som kan manifestere sig som proteinuri (ikke kendt) med eller uden samtidig anvendelse af sunitinib.
Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Oxaliplatin Capecitabin
Oxaliplatin Capecitabine
Hypertension resulterede sjældent i afbrydelse af bevacizumabbehandlingen eller hospitalsindlæggelse.
It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
● Zirabev kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer.
● Zirabev may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Nekrotiserende fasciitis c
Necrotising fasciitis c