natgillin/translations-raw huggingface dataset:
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vargatef?
What measures are being taken to ensure the safe and effective use of Vargatef?
Disse enzymer findes i visse receptorer (såsom VEGF-, FGF- og PDGF-receptorerne) på overfladen af kræftcellerne og på cellerne i det omgivende væv (f.eks. blodkar), hvor de aktiverer forskellige processer, bl.a. celledeling og vækst af nye blodkar.
These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels.
Hvad er Vargatef, og hvad anvendes det til?
What is Vargatef and what is it used for?
I tilfælde af vedvarende svære bivirkninger skal behandlingen helt standses.
If severe side effects persist, treatment should be permanently discontinued.
Behandlingen med Vargatef skal fortsætte efter ophør med docetaxel, så længe sygdommen er i bedring eller stabil, og bivirkningerne er tålelige.
Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable.
Vargatef må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nintedanib, jordnødder, soja eller andre af indholdsstofferne.
Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Vargatef indeholder det aktive stof nintedanib.
Vargatef contains the active substance nintedanib.
Hvorfor er Vargatef blevet godkendt?
Why is Vargatef approved?
Det er ikke en praktisk vejledning i, hvordan Vargatef bør anvendes.
It is not intended to provide practical advice on how to use Vargatef.
Ved svære bivirkninger kan lægen beslutte at stoppe behandlingen med Vargatef og senere genoptage den med en lavere dosis.
If severe side effects develop, the doctor may decide to interrupt treatment with Vargatef and resume it at a lower dose.
Lægemidlet anvendes i kombination med kemoterapilægemidlet docetaxel hos patienter, der i forvejen har fået kemoterapi.
The medicine is used in combination with a chemotherapy medicine called docetaxel in patients who have already received previous treatment with chemotherapy.
Vargatef udleveres kun efter recept, og ordination og behandling bør indledes og tilses af en læge med erfaring i brug af kræftmedicin.
Vargatef can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
De hyppigste bivirkninger ved Vargatef (som optræder hos mere end 1 ud af 10 patienter) er diarré, opkastning og øget indhold i blodet af bestemte leverenzymer (som kan være et tegn på leverproblemer).
The most common side effects with Vargatef (which may affect more than 1 in 10 people) include diarrhoea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vargatef, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvilke risici er der forbundet med Vargatef?
What are the risks associated with Vargatef?
Vargatef anvendes til behandling af en form for ikke-småcellet lungekræft (adenokarcinom), hvor kræften er lokalt fremskreden, har bredt sig fra udgangsstedet til andre dele af kroppen (er metastatisk) eller er vendt tilbage på det sted, hvor den oprindeligt er opstået (lokalt recidiv).
Vargatef is used to treat a type of non-small cell lung cancer called ‘adenocarcinoma', when the cancer is locally advanced, metastatic (when cancer cells have spread from the original site to other parts of the body) or locally recurrent (when the cancer has come back in the same area).
Hvis du ønsker yderligere oplysninger om behandling med Vargatef, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Vargatef, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Ved at blokere disse enzymer bremser Vargatef kræftens vækst og spredning og afskærer blodforsyningen, som sætter kræftcellerne i stand til at vokse.
By blocking these enzymes, nintedanib helps to reduce the growth and spread of the cancer and to cut off the blood supply that keeps cancer cells growing.
Det aktive stof i Vargatef, nintedanib, blokerer visse enzymer af typen tyrosinkinase.
The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
CHMP bemærkede, at Vargatef var effektivt til at bremse udviklingen i sygdommen og forlænge livet hos den undergruppe af patienter, der havde ikke-småcellet lungekræft af typen adenokarcinom.
The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type.
Den fuldstændige liste over bivirkninger og begrænsninger ved Vargatef fremgår af indlægssedlen.
For the full list of all side effects and restrictions with Vargatef, see the package leaflet.
Eftersom Vargatef ikke må gives samme dag som docetaxel, og docetaxel gives på dag 1 i en 21-dages behandlingscyklus, gives Vargatef på dag 2-21, efter at der er givet docetaxel på dag 1.
Because Vargatef must not be given on the same day as docetaxel and because docetaxel is given on day 1 of a 21-day treatment
Vargatef er et lægemiddel mod kræft og anvendes til behandling af voksne med ikke-småcellet lungekræft.
Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer.
Hvis du ønsker praktisk vejledning om anvendelsen af Vargatef, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist.
En hovedundersøgelse omfattede 1 314 patienter med fremskreden eller tilbagevendende ikkesmåcellet lungekræft, som ikke havde reageret på forudgående behandling.
In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer.
Hvilke fordele viser undersøgelserne, at der er ved Vargatef?
What benefits of Vargatef have been shown in studies?
Hvordan anvendes Vargatef?
How is Vargatef used?
Hvordan virker Vargatef?
How does Vargatef work?
Yderligere oplysninger fremgår af indlægssedlen.
For further information, see the package leaflet.
Hvad sikkerheden angår, var der flere bivirkninger hos patienter behandlet med Vargatef plus docetaxel end hos dem, der fik docetaxel alene.
Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions.
Den totale overlevelse var 12,6 måneder hos patienter, der blev behandlet med Vargatef plus docetaxel, sammenlignet med 10,3 måneder hos dem, der blev behandlet med docetaxel alene.
In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone.
De patienter, der fik Vargatef plus docetaxel, overlevede i 3,5 måneder uden forværring af sygdommen (progressionsfri overlevelse).
Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone.
Udvalget anbefalede, at der blev forelagt endnu en overdoseringsundersøgelse.
The Committee recommended that a further overdose study should be submitted.
Sådanne reaktioner er meget sjældne (berører mindre end én ud af 10 000 fugle).
These reactions are very rare (affecting less than 1 bird in 10,000).
Dette sammendrag blev senest ajourført i 07-2014.
This summary was last updated in July 2014.
Hænder og udstyr skal vaskes og desinficeres efter vaccination for at undgå spredning af virusset.
Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus.
Hvis dyret efterfølgende udsættes for virusset, vil immunsystemet reagere hurtigere.
In the future if the animals are exposed to the virus the immune system will be able to respond more quickly.
Vaccinen beskytter i 8 uger.
The period of protection is 8 weeks.
Oplysninger om udleveringsbestemmelser for produktet findes på etiketten/den ydre emballage.
Information on the prescription status of this product may be found on the label/outer package.
Effektiviteten af vaccinen blev først undersøgt hos kyllinger i en række laboratorieundersøgelser.
The effectiveness of the vaccine was first studied in a number of laboratory studies in chickens.
Tilbageholdelsestiden er den tid, der skal gå efter indgivelse af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeføde, eller æg eller mælk kan anvendes til menneskeføde.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Vacciner virker ved at “lære” organismens naturlige forsvar, immunsystemet, hvordan det skal forsvare organismen mod en sygdom.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet med den videnskabelige drøftelse i denne EPAR.
The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis IB Primo QX den 4. september 2014.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis IB Primo QX on 4 September 2014.
Laboratorieundersøgelserne viste, at vaccinen havde fuld virkning i løbet af tre uger, og at beskyttelsen holdt sig i otte uger; beskyttelsen var ikke afhængig af antistoffer overført fra moderdyret.
The laboratory studies showed that the vaccine had its full effect by three weeks and that protection lasted for eight weeks; protection was not affected by antibodies transmitted from the mother.
Vaccinen gives til kyllinger fra de er 1 dag gamle ved spraypåføring på kyllingerne eller ved dråbepåføring i øjne eller næsebor.
The vaccine is given to chickens from 1 day of age or older by spraying onto the chickens or by applying drops into the eyes or nostrils.
Ved sprayvaccinering skal der anvendes maske med øjenværn under håndtering af produktet.
If vaccinating by spray masks with eye protection should be worn when handling the product.
Levende svækket aviær infektiøs bronkitisvirus stamme D388
Live avian infectious bronchitis virus strain D388
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Nobilis IB Primo QX overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Nobilis IB Primo QX.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobilis IB Primo QX exceed the risks for the approved indication and recommended that Nobilis IB Primo QX be given a marketing authorisation.
Der blev anvendt kontrolgrupper af uvaccinerede fugle for at vise, at belastningen var effektiv.
Control groups of birds were unvaccinated to show the effectiveness of the challenge.
Derved opnås bedre beskyttelse mod smitsom bronkitis.
This will help protect them against infectious bronchitis.
Når Nobilis IB Primo QX gives til kyllinger, registrerer dyrenes immunsystem virus som “fremmede” og reagerer ved at danne antistoffer mod dem.
When Nobilis IB Primo QX is given to chickens the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Efter vaccination kan der i mindst 10 dage forekomme en kortvarig mild luftvejsreaktion med udflåd fra næsen.
After vaccination a mild short lived reaction in the airways, including a nasal discharge, may occur for at least 10 days.
Formålet var at finde ud af, hvor lang tid det tog for kyllinger at opnå fuld beskyttelse, hvor længe vaccinen beskytter mod smitsom bronkitis forårsaget af QX-lignende varianter, og i hvor høj grad vaccinens virkning afhænger af antistoffer, der overføres fra moderdyret.
The purpose of the studies was to establish how long it took for chickens to be fully protected, the length of time protection lasts against infectious bronchitis due to QX-like variants, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Nobilis IB Primo QX må ikke gives til æglæggende fugle senere end fire uger før æglægningsperioden begynder.
Nobilis IB Primo QX must not be given to birds which are laying eggs or within 4 weeks before the start of the laying period.
Det smitsomme bronkitisvirus i Nobilis IB Primo QX er blevet svækket, så det ikke kan forårsage sygdom.
The avian infection bronchitis virus in Nobilis IB Primo QX has been attenuated (weakened) so that it does not cause disease.
I endnu en undersøgelse blev 42 slagtekyllinger sprayvaccineret, da de var 1 dag gamle, og blev tre uger efter vaccinationen belastet med en QX-stamme af virusset.
In a second study 42 broiler chickens were spray vaccinated at 1 day old and challenged 3 weeks after vaccination with a QX strain of the virus.
To grupper på 28 fugle blev belastet med virusset 3 uger efter at være blevet vaccineret, den ene med en QX-stamme, den anden med en anden stamme, M41.
Two groups of 28 birds were challenged with the virus 3 weeks after vaccination, one group with a QX strain and the second group with another strain called M41.
Nobilis IB Primo QX fås som et frysetørret pulver (et lyofilisat), der kan leveres med opløsningsvæske (solvens).
Nobilis IB Primo QX is available as a lyophilisate (freeze-dried powder) which may be supplied with a solvent.
Tilbageholdelsestiden for Nobilis IB Primo QX for kyllinger er 0 døgn.
The withdrawal period for Nobilis IB Primo QX for chickens is zero days.
I den første feltundersøgelse var 100 % af de fugle, der var vaccineret med Nobilis IB Primo QX blandet med Nobilis IB Ma5, beskyttet mod QX-stammen, og 90 % var beskyttet mod M41, sammenholdt med ingen af de uvaccinerede fugle.
In the first field study 100% of the birds vaccinated with Nobilis IB Primo QX mixed with Nobilis IB Ma5 were protected from the QX strain and 90% were protected from M41, compared with none of the unvaccinated birds.
Effektiviteten af Nobilis IB Primo QX blev undersøgt i to feltundersøgelser.
The effectiveness of Nobilis IB Primo QX was investigated in two field studies.
Den anden feltundersøgelse viste, at 93 % af de fugle, der var vaccineret med Nobilis IB Primo QX, og ingen af de uvaccinerede fugle var beskyttet mod belastningen.
The second field study showed 93% of the Nobilis IB Primo QX vaccinated birds and none of the unvaccinated birds to be protected from the challenge.
I den første undersøgelse blev slagtekyllinger sprayvaccineret med både Nobilis IB Primo QX og Nobilis IB Ma5, en vaccine mod en Massachusetts-stamme af smitsomt bronkitisvirus.
In the first study broiler chickens (chickens bred for meat) were spray vaccinated with both Nobilis IB Primo QX and Nobilis IB Ma5, a vaccine against a Massachusetts strain of infectious bronchitis virus.
Nobilis IB Primo QX anvendes til at beskytte kyllinger mod smitsom virusbronkitis forårsaget af stammer af smitsomt bronkitisvirus med betegnelsen QX-varianter såsom stamme D388.
Nobilis IB Primo QX is used to protect chickens against viral infectious bronchitis caused by strains of infectious bronchitis virus known as QX-like variants, such as strain D388.
Nobilis IB Primo QX er en vaccine.
Nobilis IB Primo QX is a vaccine.
Vaccinen skal opslæmmes før brug.
The vaccine is to be made up into a suspension for use.
Nobilis IB Primo QX er en veterinær vaccine, der indeholder levende, svækket smitsom fuglebronkitis virus stamme D388.
Nobilis IB Primo QX is a veterinary vaccine that contains live attenuated (weakened) avian infectious bronchitis virus strain D388.
Andre oplysninger om Nobilis IB Primo QX:
Other information about Nobilis IB Primo QX:
Hvilken risiko er der forbundet med Nobilis IB Primo QX?
What is the risk associated with Nobilis IB Primo QX?
Hvorfor blev Nobilis IB Primo QX godkendt?
Why has Nobilis IB Primo QX been approved?
Hvad er Nobilis IB Primo QX?
What is Nobilis IB Primo QX?
Hvordan blev Nobilis IB Primo QX undersøgt?
How has Nobilis IB Primo QX been studied?
Hvordan virker Nobilis IB Primo QX?
How does Nobilis IB Primo QX work?
Hvad anvendes Nobilis IB Primo QX til?
What is Nobilis IB Primo QX used for?
Hvilken fordel viser undersøgelserne, at der er ved Nobilis IB Primo QX?
What benefit has Nobilis IB Primo QX shown during the studies?
Utilstrækkelig respons
Inadequate response
De betragtes som så inerte, at ingen testning var påkrævet.
They were considered so inert that testing was not required.
For at undgå enhver uønsket hændelse skal følgende instrukser nøje overholdes.
In order to avoid all incidents, the following instructions should be absolutely respected.
- Hvis De har fået at vide, at De (som patient) eller Deres barn (som patient) har unormalt kredsløb i hjertet.
- If you have been told that you (as the patient) or your child (as the patient) have an abnormal circulation within the heart.
Den potientelle risiko for mennesker er ukendt.
The potential risk for humans is unknown.
Opbevaringen overvåges af specialister på hospitalet.
Storage is supervised by the specialists at the hospital.
Det prospektivt definerede primære slutpunkt var modtagelsen af ECMO.
The prospectively defined primary endpoint was the receipt of ECMO.
• på anmodning af det Europæiske Lægemiddelagentur
At the request of the European Medicines Agency;
Behandlingens varighed er variabel, men typisk mindre end 4 dage.
The duration of therapy is variable, but typically less than four days.
Kliniske data, der understøtter den foreslåede dosis i aldersgruppen 12-17 år, er begrænsede.
Clinical data supporting the suggested dose in the age range 12-17 years is limited.
De tilgængelige data er beskrevet i afsnit 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
Currently available data are described in section 5.1 but no recommendation or posology can be made.
Resumé af sikkerhedsprofil
Summary of safety profile
Opfølgende undersøgelser ved en alder på 18-24 måneder var ens for de to grupper med hensyn til mental, motorisk, audiologisk og neurologisk vurdering.
Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations.
Til metalkonstruktioner kan kun rustfrit stål anbefales.
Among metallic construction materials, only stainless steel can be recommended.
Bradykardib (efter pludselig seponering af behandlingen)
Bradycardiab (following abrupt discontinuation of therapy)
Højere eksponeringer er ikke undersøgt.
Higher exposures have not been investigated.
Det forsøges at finde den mindste dosis, der er effektiv.
The lowest effective dose will be sought.
Umiddelbart forud for initieringen af den enkelte patient skal der foretages en korrekt procedure for at rense systemet for NO2.
Immediately prior to each patient initiation, proper procedure must be applied to purge the system of NO2.
De viste hyppighedskategorier benytter følgende konvention: meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1,000), meget sjældne (<1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
The displayed frequency categories use 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), very rare (<1/10,000), not known (cannot be estimated from the available data).
Rebound kan forekomme både tidligt og sent i behandlingen.
The rebound may be seen early as well as late during therapy.
Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time
Hvis det vurderes, at den kliniske respons er utilstrækkelig 4-6 timer efter påbegyndelse af INOmax, skal følgende overvejes.
If it is judged that clinical response is inadequate at 4-6 hours after starting INOmax, the following should be considered.
Energiforsyningen til monitoreringsudstyret skal være uafhængig af tilførselsanordningens funktion.
The power supply for the monitoring equipment should be independent of the delivery device function.
Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
If you get any side effects, talk to your doctor or pharmacist or nurse.
Nitrogenoxid (NO2)-koncentrationen og FiO2 skal ligeledes måles samme sted ved hjælp af kalibreret og godkendt (CE-mærket) monitoreringsudstyr.
The nitrogen dioxide (NO2) concentration and FiO2 must also be measured at the same site using calibrated and approved (CE-marked) monitoring equipment.
Koncentrationen af NO2 skal holdes så lav som muligt og altid < 0,5 ppm.
The NO2 concentration should be maintained as low as possible and always < 0.5 ppm.
De indsamlede bivirkninger havde samme incidensrate i begge grupper.
The adverse events collected occurred at similar incidence rates in both groups.
Ved utilstrækkelig respons kan dosis titreres efter mindst 10 minutter.
In case of insufficient response the dose may be titrated after a minimum of 10 minutes.
Effekter i ikke-kliniske undersøgelser blev kun observeret ved eksponeringer, der blev betragtet som værende væsentligt over den maksimale humane eksponering, hvilket tyder på begrænset relevans for den kliniske anvendelse.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Behandlingen med INOmax kan dog vare længere.
However, therapy with INOmax may last longer.
4.2 for information om monitorering af NO2.
See section 4.2 for information on monitoring for NO2.
Klinisk signifikant interaktion med andre lægemidler anvendt i behandlingen af hypoxisk respirationssvigt kan ikke udelukkes på baggrund af de tilgængelige data.
A clinically significant interaction with other medicinal products used in the treatment of hypoxic respiratory failure cannot be excluded based on the available data.
Dette kan øge den højre ventrikels ejektionsfraktion.
This may increase the right ventricular ejection fraction.
Det skal overvejes at seponere behandlingen, hvis der ikke ses nogen gunstige fysiologiske effekter efter behandlingsforsøg i 30 minutter.
Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
Livredning, f.eks. ekstrakorporal membranoxygenering (ECMO) hvor dette er tilgængeligt, bør baseres på kontinuert forværring eller slet ingen forbedring, defineret efter kriterier baseret på lokale forhold.
Rescue, such as Extra Corporeal Membrane Oxygenation (ECMO) where available, should be considered based on continued deterioration or failure to improve, defined by criteria based on local circumstances.