natgillin/translations-raw huggingface dataset:
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCPCh FeLV den 23. februar 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Den kan desuden forebygge dødelighed forårsaget af panleukopeni og forhindre, at FeLV forbliver i blodet.
It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Antistofferne vil medvirke til at beskytte mod de sygdomme, der forårsages af disse virus eller bakterier.
The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Hvis killingen har høje niveauer af antistoffer, som den har modtaget fra moderen i livmoderen og i mælken, bør den første vaccination vente til 12-ugers alderen.
If the kitten has high levels of antibodies received from the mother in the womb and in the milk, the first vaccination should be delayed until 12 weeks of age.
Når katten senere i livet udsættes for sådanne virus eller bakterier, vil katten enten ikke blive inficeret eller få en langt mindre alvorlig infektion.
When exposed to any of these viruses or bacteria later in life, the cat will either not become infected or have a much less serious infection.
Oplysninger om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/den ydre emballage.
Information on the prescription status of this product may be found on the label/outer package.
Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
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.
For C. felis kunne der ikke påvises stigning i antistoffer på grund af de høje niveauer af antistoffer i kattene ved undersøgelsens begyndelse.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Der kan komme en lokal reaktion på injektionsstedet med let berøringsømhed, kløe eller hævelse (ødem), som svinder i løbet af en til to uger.
There may be a local reaction at the injection site, with slight pain on touching, itching or oedema (swelling), which disappears within one or two weeks.
Derefter vil immunsystemet fremover kunne danne antistoffer hurtigere, når det møder de samme virus eller bakterier igen.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Canarypox-virusset kan ikke spredes eller formere sig i katten, men danner alligevel proteiner fra FeLV-generne.
The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Det vigtigste mål for effektiviteten var blodets indhold af antistoffer mod virusserne og bakterierne i vaccinen bortset fra FeLV-komponenten, hvis effektivitet til forebyggelse af infektion allerede var påvist i andre undersøgelser.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine, with the exception of the FeLV component, whose effectiveness in preventing infection had already been demonstrated in other studies.
Undertiden får kattene forbigående tab af interesse for omgivelserne (apati), appetitløshed (anoreksi) og forhøjet kropstemperatur (hypertermi) af en til to dages varighed.
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Katten bør revaccineres for alle komponenter ét år efter det første vaccinationsforløb, derefter hvert år for klamydia og felin leukæmi, og hvert tredje år for rhinotracheitis, calicivirose og panleukopeni.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis and feline leukaemia, and every three years for rhinotracheitis, calicivirosis and panleucopenia.
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RCPCh FeLV overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Purevax RCPCh FeLV.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh FeLV exceed the risks for the approved indications and recommended that Purevax RCPCh FeLV be given a marketing authorisation.
Hvis der alligevel sker selvinjektion hos sådanne personer, skal lægen have at vide, at der er sket selvinjektion med en levende klamydiavaccine.
If self-injection does occur in these people, the doctor should be told that self-injection with a live chlamydial vaccine has occurred.
Når en kat får vaccinen, opfatter immunsystemet de svækkede eller dræbte virus, FeLV-proteinerne og de svækkede bakterier som "fremmede" og danner antistoffer mod dem.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses, the FeLV proteins, and the weakened bacteria as ‘foreign' and makes antibodies against them.
Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at anvende veterinærlægemidlet som beskrevet nedenfor.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
• felin leukæmivirus (FeLV) rekombinant canarypoxvirus (vCP97).
• feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Feltundersøgelserne af Purevax RCPCh FeLV vedrørte basisvaccinationsplanen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen.
In the field, the studies of Purevax RCPCh FeLV looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and the booster vaccination.
Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
The benefit-risk balance may be found in the scientific discussion module of this EPAR.
• inaktiverede (dræbte) calicivirose-antigener (stamme FCV 431 og G1)
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
• svækket Chlamydophila felis (stamme 905)
• attenuated Chlamydophila felis (905 strain),
For at beskytte mod felin leukæmi indeholder vaccinen to gener fra FeLV, env og gag, som er indsat i et andet vektor- eller bærevirus, canarypox, ved hjælp af "rekombinant DNA-teknologi".
To protect against feline leukaemia, the vaccine contains two genes from the FeLV called env and gag, which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Purevax RCPCh FeLV leveres som et lyofilisat (en frysetørret pellet) med opløsningsvæske (solvens), der benyttes til at fremstille en suspension til indsprøjtning.
Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Effektiviteten af Purevax RCPCh FeLV er undersøgt under laboratorieforhold i flere undersøgelser, hvor kattene blev vaccineret og inficeret med herpesvirus, calicivirus, C. felis, parvovirus eller leukæmivirus.
The effectiveness of Purevax RCPCh FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis, parvovirus or leukaemia virus.
Purevax RCPCh FeLV bør ikke anvendes hos drægtige katte.
Purevax RCPCh FeLV should not be used in pregnant cats.
Purevax RCPCh FeLV anvendes til at vaccinere katte fra 8-ugers alderen mod:
Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
• svækket felin panleukopenivirus (PLI IV)
• attenuated feline panleucopenia virus (PLI IV),
Purevax RCPCh FeLV er en veterinær vaccine, der indeholder:
Purevax RCPCh FeLV is a veterinary vaccine that contains:
Den næste injektion gives tre til fire uger senere.
The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Purevax RCPCh FeLV indeholder små mængder svækkede eller dræbte virus og bakterier, der forårsager felin viral rhinotracheitis, calicivirose, klamydia og panleukopeni.
Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
• svækket felin rhinotracheitis herpesvirus (FHV F2-stamme)
• attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Felin viral rhinotracheitis-, felin klamydia-, felin panleukopeni- (levende, svækket), felin leukæmi- og felin calicivirose- (inaktiveret) vaccine
Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Andre oplysninger om Purevax RCPCh FeLV:
Other information about Purevax RCPCh FeLV:
Purevax RCPCh FeLV er en vaccine.
Purevax RCPCh FeLV is a vaccine.
• felin panleukopeni (en alvorlig sygdom med blodig diarré, forårsaget af et parvovirus)
• feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
I undersøgelsen vedrørende boostervaccination holdt indholdet af antistoffer mod rhinotracheitis herpesvirus, calicivirus-infektion, felin panleukopenivirus og C. felis og sig stabilt på et højt niveau eller steg en smule.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly.
I feltundersøgelsen af basisvaccination var der stigning i antistoffer mod felin rhinotracheitis herpesvirus, calicivirus-infektion og felin panleukopenivirus.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Den fuldstændige liste over indberettede bivirkninger med Purevax RCPCh FeLV fremgår af indlægssedlen.
For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
• felin leukæmi (en sygdom, der angriber immunsystemet og er forårsaget af retrovirusset felin leukæmivirus).
• feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
Purevax RCPCh FeLV er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser.
In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
• felin klamydia (en influenzalignende sygdom forårsaget af bakterien C. felis)
• feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
• felin viral rhinotracheitis (en influenzalignende sygdom, der skyldes et herpesvirus)
• feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
• felin calicivirose (en influenzalignende sygdom med betændelse i munden, der skyldes et calicivirus)
• feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Hvorfor blev Purevax RCPCh FeLV godkendt?
Why has Purevax RCPCh FeLV been approved?
Hvilken risiko er der forbundet med Purevax RCPCh FeLV?
What is the risk associated with Purevax RCPCh FeLV?
Hvad er Purevax RCPCh FeLV?
What is Purevax RCPCh FeLV?
Hvordan blev Purevax RCPCh FeLV undersøgt?
How has Purevax RCPCh FeLV been studied?
Hvad anvendes Purevax RCPCh FeLV til?
What is Purevax RCPCh FeLV used for?
Hvordan virker Purevax RCPCh FeLV?
How does Purevax RCPCh FeLV work?
Hvilken fordel viser undersøgelserne, at der er ved Purevax RCPCh FeLV?
What benefit has Purevax RCPCh FeLV shown during the studies?
Dette sammendrag blev sidst ajourført i 09-2013.
This summary was last updated in 09-2013.
Bivirkningerne i undersøgelserne var generelt godartede og blev anset for at kunne behandles.
Side effects seen in studies were generally benign and were considered manageable.
CHMP fandt imidlertid, at dets virkning i form af nedsættelse af andelen af tilbagefald var for lille til, at det bør anbefales til reduktion af tilbagefald.
However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend its use for reducing exacerbations.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xoterna Breezhaler den 19. september 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Xoterna Breezhaler on 19 September 2013.
Den fuldstændige EPAR for Xoterna Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Xoterna Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Den anbefalede dosis er én inhalation en gang dagligt af pulveret i en enkelt kapsel.
The recommended dose is one inhalation once a day of the powder content of a single capsule.
Det anvendes som vedholdende behandling til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Den kombinerede virkning af de to aktive stoffer holder luftvejene bedre åbne, så patienten lettere kan trække vejret.
The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Indacaterol er en langtidsvirkende beta-2-agonist.
Indacaterol is a long-acting beta-2 agonist.
Glycopyrronium er en muskarin receptorantagonist.
Glycopyrronium is a muscarinic receptor antagonist.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xoterna Breezhaler.
This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Xoterna Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xoterna Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Når indacaterol inhaleres, når det frem til receptorerne i luftvejene og aktiverer dem.
When inhaled, indacaterol reaches the receptors in the airways and activates them.
Xoterna Breezhaler var genstand for to hovedundersøgelser, hvori der deltog i alt 2 667 patienter med KOL.
Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så indånding og udånding vanskeliggøres.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.
Det virker ved at bindes til beta-2-adrenerge receptorer, der findes i musklerne i mange organer, herunder luftvejene.
It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Xoterna Breezhaler er et lægemiddel, der indeholder to aktive stoffer, nemlig indacaterol (85 mikrogram) og glycopyrronium (43 mikrogram).
Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Der er udarbejdet en risikostyringsplan for at sikre, at Xoterna Breezhaler anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Xoterna Breezhaler is used as safely as possible.
De hyppigste bivirkninger ved Xoterna Breezhaler (som kan forekomme hos flere end 1 ud af 10 patienter) er infektioner i de øvre luftveje (forkølelse).
The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Hos patienter med stærkt nedsat nyrefunktion bør Xoterna Breezhaler kun anvendes efter nøje afvejning af fordelene i forhold til risiciene.
In patients with severely reduced kidney function Xoterna Breezhaler should only be used after a careful benefit-risk assessment.
Derved afslappes musklerne i luftvejene.
This causes the muscles of the airways to relax.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xoterna Breezhaler, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xoterna Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Xoterna Breezhaler øgede desuden FEV1 med 70 ml mere end indacaterol alene og 90 ml mere end glycopyrronium alene.
Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml than glycopyrronium alone.
Det virker ved at blokere receptorer af den muskarine type, der kontrollerer musklernes sammentrækning.
It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Der må ikke bruges nogen anden inhalator til at inhalere indholdet af kapslerne.
The contents of the capsules must not be inhaled using any other device.
Når glycopyrronium inhaleres, virker det afslappende på musklerne i luftvejene.
When glycopyrronium is inhaled, it causes the muscles of the airways to relax.
Virkningerne af Xoterna Breezhaler til lindring af symptomerne på KOL havde klinisk betydning.
The effects of Xoterna Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Hvis du ønsker yderligere oplysninger om behandling med Xoterna Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Den første undersøgelse viste, at Xoterna Breezhaler var mere effektivt end placebo og i gennemsnit øgede FEV1 med 200 ml mere.
The first study showed that treatment with Xoterna Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xoterna Breezhaler?
What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler?
Faldet i andelen af tilbagefald var 10-12 % større med Xoterna Breezhaler end med tiotropium og glycopyrronium.
The reduction in the rate of exacerbations was 10 to 12% higher with Xoterna Breezhaler than with tiotropium and glycopyrronium.
I begge undersøgelser blev virkningen hovedsagelig bedømt på, hvordan 26 ugers behandling med Xoterna Breezhaler forbedrede patienternes forcerede udåndingsvolumen (FEV1, der er den maksimale mængde luft, en person kan udånde på et sekund).
In both studies, the main measure of effectiveness was how Xoterna Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Det skal tages på samme klokkeslæt hver dag ved hjælp af Xoterna Breezhaler-inhalatoren.
It is taken at the same time each day using the Xoterno Breezhaler device.
Vedrørende sikkerheden er Xoterna Breezhaler sammenligneligt med indacaterol og glycopyrronium, når disse anvendes hver for sig.
Regarding its safety, Xoterna Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Begge aktive stoffer i Xoterna Breezhaler, indacaterol og glycopyrronium, udvider luftvejene og forbedrer vejrtrækningen ved KOL, men de virker på forskellige måder.
The active substances in Xoterna Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
I den anden undersøgelse var den gennemsnitlige stigning i FEV1 140 ml større med Xoterna Breezhaler end med fluticason og salmeterol.
In the second study the average increase in FEV1 was 140 ml more with Xoterna Breezhaler than with treatment with fluticasone and salmeterol.
Andre oplysninger om Xoterna Breezhaler
Other information about Xoterna Breezhaler
Hvad er Xoterna Breezhaler, og hvad anvendes det til?
What is Xoterna Breezhaler and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Xoterna Breezhaler bør anvendes.
It is not intended to provide practical advice on how to use Xoterna Breezhaler.
Hvorfor er Xoterna Breezhaler blevet godkendt?
Why is Xoterna Breezhaler approved?
Hvis du ønsker praktisk vejledning i anvendelsen af Xoterna Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Xoterna Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Xoterna Breezhaler leveres som inhalationspulver i kapsler og udleveres kun efter recept.
Xoterna Breezhaler is available as capsules containing a powder for inhalation can only be obtained with a prescription.
Den fuldstændige liste over indberettede bivirkninger ved Xoterna Breezhaler fremgår af indlægssedlen.
For the full list of all side effects reported with Xoterna Breezhaler, see the package leaflet.
Hvilken risiko er der forbundet med Xoterna Breezhaler?
What are the risks associated with Xoterna Breezhaler?
En tredje undersøgelse vedrørte virkningerne af 64 ugers behandling med Xoterna Breezhaler på andelen af tilbagefald, sammenlignet med glycopyrronium eller tiotropium (andre midler mod KOL).
A third study studied the effects of Xoterna Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Hvordan anvendes Xoterna Breezhaler?
How is Xoterna Breezhaler used?
Det er almindeligt at behandle KOL med en kombination af muskarine receptorantagonister og langtidsvirkende beta-2-adrenerge agonister.
Muscarinic receptor antagonists and long-acting beta-2-adrenergic agonists are commonly combined in the management of COPD.
Hvilke fordele viser undersøgelserne, at der er ved Xoterna Breezhaler?
What benefits of Xoterna Breezhaler have been shown in studies?
Den ene undersøgelse sammenlignede virkningerne af Xoterna Breezhaler med virkningerne af placebo (en virkningsløs behandling) eller med indacaterol eller glycopyrronium alene.
While one study compared the effects of Xoterna Breezhaler with those of placebo (a dummy treatment), or indacaterol or glycopyrronium alone, the other study compared Xoterna Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Hvordan virker Xoterna Breezhaler?
How does Xoterna Breezhaler work?
Yderligere information vedrørende Vyxeos findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Vyxeos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
De griber på forskellige måder ind i produktionen af nyt dna i cellerne, og det betyder, at cellerne ikke kan vokse og formere sig, og til sidst dør de.
They interfere in different ways with the production of new DNA within cells, which means the cells are unable to grow and multiply, and they eventually die.
Andre oplysninger om Vyxeos
Other information about Vyxeos
Som for alle lægemidler bliver data vedrørende brugen af Vyxeos løbende overvåget.
As for all medicines, data on the use of Vyxeos are continuously monitored.
Bivirkningerne var de samme som de kendte bivirkninger ved de aktive stoffer og vurderes at være håndterbare.
The side effects were similar to the known side effects of the active substances and were considered manageable.