FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Juluca have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Juluca.
English: This summary was last updated in January 2015.
Danish: Dette sammendrag blev sidst ajourført i januar 2015.
English: This document cannot replace a face-to-face discussion with your veterinarian.
Danish: Dette dokument kan ikke erstatte en personlige drøftelse med din dyrlæge.
English: The vaccine should not be handled by people with a weak immune system.
Danish: Vaccinen bør ikke håndteres af personer med svagt immunsystem.
English: The vaccine is given as two doses injected under the skin.
Danish: Vaccinen gives som to doser, der injiceres under huden.
English: They included young and adult cats of various breeds, but not young kittens.
Danish: De omfattede unge og voksne katte af forskellige racer, men ikke små killinger.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige drøftelse (også en del af denne EPAR).
English: The vaccine helps to reduce the symptoms of the diseases.
Danish: Vaccinen medvirker til at mindske symptomerne på sygdommene.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Danish: Hvis du ønsker yderligere oplysninger om dit dyrs sygdomstilstand eller behandling, kan du kontakte din dyrlæge.
English: This is a summary of the European public assessment report.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
English: It also helps to reduce viral excretion in case of calicivirus infection for one year after vaccination.
Danish: Den medvirker desuden til at reducere virusudskillelsen i tilfælde af infektion med calicivirus i ét år efter vaccination.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh FeLV on 23 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCPCh FeLV den 23. februar 2005.
English: It can also prevent death due to panleucopenia and prevent FeLV from remaining in the blood.
Danish: Den kan desuden forebygge dødelighed forårsaget af panleukopeni og forhindre, at FeLV forbliver i blodet.
English: The antibodies will help to protect against the diseases caused by these viruses or bacteria.
Danish: Antistofferne vil medvirke til at beskytte mod de sygdomme, der forårsages af disse virus eller bakterier.
English: 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.
Danish: 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.
English: 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.
Danish: Når katten senere i livet udsættes for sådanne virus eller bakterier, vil katten enten ikke blive inficeret eller få en langt mindre alvorlig infektion.
English: Information on the prescription status of this product may be found on the label/outer package.
Danish: Oplysninger om udleveringsbestemmelserne for dette lægemiddel findes på etiketten/den ydre emballage.
English: In case of accidental self-injection medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" organismens naturlige forsvar, immunsystemet, hvordan det skal forsvare organismen mod en sygdom.
English: 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.
Danish: For C. felis kunne der ikke påvises stigning i antistoffer på grund af de høje niveauer af antistoffer i kattene ved undersøgelsens begyndelse.
English: 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.
Danish: Der kan komme en lokal reaktion på injektionsstedet med let berøringsømhed, kløe eller hævelse (ødem), som svinder i løbet af en til to uger.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria.
Danish: Derefter vil immunsystemet fremover kunne danne antistoffer hurtigere, når det møder de samme virus eller bakterier igen.
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Danish: Canarypox-virusset kan ikke spredes eller formere sig i katten, men danner alligevel proteiner fra FeLV-generne.
English: 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.
Danish: 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.
English: 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.
Danish: Undertiden får kattene forbigående tab af interesse for omgivelserne (apati), appetitløshed (anoreksi) og forhøjet kropstemperatur (hypertermi) af en til to dages varighed.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: If self-injection does occur in these people, the doctor should be told that self-injection with a live chlamydial vaccine has occurred.
Danish: Hvis der alligevel sker selvinjektion hos sådanne personer, skal lægen have at vide, at der er sket selvinjektion med en levende klamydiavaccine.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Danish: • felin leukæmivirus (FeLV) rekombinant canarypoxvirus (vCP97).
English: 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.
Danish: Feltundersøgelserne af Purevax RCPCh FeLV vedrørte basisvaccinationsplanen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Danish: • inaktiverede (dræbte) calicivirose-antigener (stamme FCV 431 og G1)
English: • attenuated Chlamydophila felis (905 strain),
Danish: • svækket Chlamydophila felis (stamme 905)
English: 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'.
Danish: 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".
English: Purevax RCPCh FeLV is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Danish: Purevax RCPCh FeLV leveres som et lyofilisat (en frysetørret pellet) med opløsningsvæske (solvens), der benyttes til at fremstille en suspension til indsprøjtning.
English: 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.
Danish: 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.
English: Purevax RCPCh FeLV should not be used in pregnant cats.
Danish: Purevax RCPCh FeLV bør ikke anvendes hos drægtige katte.
English: Purevax RCPCh FeLV is used to vaccinate cats from the age of 8 weeks against:
Danish: Purevax RCPCh FeLV anvendes til at vaccinere katte fra 8-ugers alderen mod:
English: • attenuated feline panleucopenia virus (PLI IV),
Danish: • svækket felin panleukopenivirus (PLI IV)
English: Purevax RCPCh FeLV is a veterinary vaccine that contains:
Danish: Purevax RCPCh FeLV er en veterinær vaccine, der indeholder:
English: The first injection should be given in kittens aged at least eight weeks, with a second injection three to four weeks later.
Danish: Den næste injektion gives tre til fire uger senere.
English: Purevax RCPCh FeLV contains small amounts of weakened or killed viruses and bacteria that cause feline viral rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Danish: Purevax RCPCh FeLV indeholder små mængder svækkede eller dræbte virus og bakterier, der forårsager felin viral rhinotracheitis, calicivirose, klamydia og panleukopeni.
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Danish: • svækket felin rhinotracheitis herpesvirus (FHV F2-stamme)
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated), feline leukaemia and feline calicivirosis (inactivated) vaccine
Danish: Felin viral rhinotracheitis-, felin klamydia-, felin panleukopeni- (levende, svækket), felin leukæmi- og felin calicivirose- (inaktiveret) vaccine
English: Other information about Purevax RCPCh FeLV:
Danish: Andre oplysninger om Purevax RCPCh FeLV:
English: Purevax RCPCh FeLV is a vaccine.
Danish: Purevax RCPCh FeLV er en vaccine.
English: • feline panleucopenia (a serious illness causing bloody diarrhoea caused by a parvovirus),
Danish: • felin panleukopeni (en alvorlig sygdom med blodig diarré, forårsaget af et parvovirus)
English: 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.
Danish: 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.
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus, calicivirus infection, and feline panleucopenia viruses.
Danish: I feltundersøgelsen af basisvaccination var der stigning i antistoffer mod felin rhinotracheitis herpesvirus, calicivirus-infektion og felin panleukopenivirus.
English: For a full list of the side-effects reported with Purevax RCPCh FeLV, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Purevax RCPCh FeLV fremgår af indlægssedlen.
English: • feline leukaemia (an illness affecting the immune system caused by a retrovirus, feline leukaemia virus).
Danish: • felin leukæmi (en sygdom, der angriber immunsystemet og er forårsaget af retrovirusset felin leukæmivirus).
English: In laboratory conditions, Purevax RCPCh FeLV was demonstrated to provide protection against the diseases listed above.
Danish: Purevax RCPCh FeLV er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser.
English: • feline chlamydiosis (a flu-like illness caused by the bacterium C. felis),
Danish: • felin klamydia (en influenzalignende sygdom forårsaget af bakterien C. felis)
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Danish: • felin viral rhinotracheitis (en influenzalignende sygdom, der skyldes et herpesvirus)
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Danish: • felin calicivirose (en influenzalignende sygdom med betændelse i munden, der skyldes et calicivirus)
English: Why has Purevax RCPCh FeLV been approved?
Danish: Hvorfor blev Purevax RCPCh FeLV godkendt?
English: What is the risk associated with Purevax RCPCh FeLV?
Danish: Hvilken risiko er der forbundet med Purevax RCPCh FeLV?
English: What is Purevax RCPCh FeLV?
Danish: Hvad er Purevax RCPCh FeLV?
English: How has Purevax RCPCh FeLV been studied?
Danish: Hvordan blev Purevax RCPCh FeLV undersøgt?
English: What is Purevax RCPCh FeLV used for?
Danish: Hvad anvendes Purevax RCPCh FeLV til?
English: How does Purevax RCPCh FeLV work?
Danish: Hvordan virker Purevax RCPCh FeLV?
English: What benefit has Purevax RCPCh FeLV shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax RCPCh FeLV?
English: This summary was last updated in 09-2013.
Danish: Dette sammendrag blev sidst ajourført i 09-2013.
English: EMA/CHMP/472762/2013 EMEA/H/C/003755
Danish: EMA/472762/2013 EMEA/H/C/003755
English: Side effects seen in studies were generally benign and were considered manageable.
Danish: Bivirkningerne i undersøgelserne var generelt godartede og blev anset for at kunne behandles.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend its use for reducing exacerbations.
Danish: 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.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xoterna Breezhaler on 19 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xoterna Breezhaler den 19. september 2013.
English: 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.
Danish: Den fuldstændige EPAR for Xoterna Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one inhalation once a day of the powder content of a single capsule.
Danish: Den anbefalede dosis er én inhalation en gang dagligt af pulveret i en enkelt kapsel.
English: It is used as maintenance (regular) treatment to relieve symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Det anvendes som vedholdende behandling til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily.
Danish: Den kombinerede virkning af de to aktive stoffer holder luftvejene bedre åbne, så patienten lettere kan trække vejret.
English: Indacaterol is a long-acting beta-2 agonist.
Danish: Indacaterol er en langtidsvirkende beta-2-agonist.
English: Glycopyrronium is a muscarinic receptor antagonist.
Danish: Glycopyrronium er en muskarin receptorantagonist.
English: This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xoterna Breezhaler.
English: 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.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Xoterna Breezhaler opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: When inhaled, indacaterol reaches the receptors in the airways and activates them.
Danish: Når indacaterol inhaleres, når det frem til receptorerne i luftvejene og aktiverer dem.
English: Xoterna Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Danish: Xoterna Breezhaler var genstand for to hovedundersøgelser, hvori der deltog i alt 2 667 patienter med KOL.
English: 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.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så indånding og udånding vanskeliggøres.
English: It works by attaching to beta-2-adrenergic receptors found in the muscles of many organs including the airways of the lungs.
Danish: Det virker ved at bindes til beta-2-adrenerge receptorer, der findes i musklerne i mange organer, herunder luftvejene.
English: Xoterna Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Danish: Xoterna Breezhaler er et lægemiddel, der indeholder to aktive stoffer, nemlig indacaterol (85 mikrogram) og glycopyrronium (43 mikrogram).
English: A risk management plan has been developed to ensure that Xoterna Breezhaler is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Xoterna Breezhaler anvendes så sikkert som muligt.
English: The most common side effects with Xoterna Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Danish: De hyppigste bivirkninger ved Xoterna Breezhaler (som kan forekomme hos flere end 1 ud af 10 patienter) er infektioner i de øvre luftveje (forkølelse).
English: In patients with severely reduced kidney function Xoterna Breezhaler should only be used after a careful benefit-risk assessment.
Danish: Hos patienter med stærkt nedsat nyrefunktion bør Xoterna Breezhaler kun anvendes efter nøje afvejning af fordelene i forhold til risiciene.
English: This causes the muscles of the airways to relax.
Danish: Derved afslappes musklerne i luftvejene.
English: 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.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xoterna Breezhaler, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Xoterna Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml than glycopyrronium alone.
Danish: Xoterna Breezhaler øgede desuden FEV1 med 70 ml mere end indacaterol alene og 90 ml mere end glycopyrronium alene.
English: It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles.
Danish: Det virker ved at blokere receptorer af den muskarine type, der kontrollerer musklernes sammentrækning.
English: The contents of the capsules must not be inhaled using any other device.
Danish: Der må ikke bruges nogen anden inhalator til at inhalere indholdet af kapslerne.
English: When glycopyrronium is inhaled, it causes the muscles of the airways to relax.
Danish: Når glycopyrronium inhaleres, virker det afslappende på musklerne i luftvejene.
English: The effects of Xoterna Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Danish: Virkningerne af Xoterna Breezhaler til lindring af symptomerne på KOL havde klinisk betydning.
English: For more information about treatment with Xoterna Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: The first study showed that treatment with Xoterna Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Danish: Den første undersøgelse viste, at Xoterna Breezhaler var mere effektivt end placebo og i gennemsnit øgede FEV1 med 200 ml mere.
English: What measures are being taken to ensure the safe and effective use of Xoterna Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xoterna Breezhaler?
English: The reduction in the rate of exacerbations was 10 to 12% higher with Xoterna Breezhaler than with tiotropium and glycopyrronium.
Danish: Faldet i andelen af tilbagefald var 10-12 % større med Xoterna Breezhaler end med tiotropium og glycopyrronium.
English: 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.
Danish: 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).
English: It is taken at the same time each day using the Xoterno Breezhaler device.
Danish: Det skal tages på samme klokkeslæt hver dag ved hjælp af Xoterna Breezhaler-inhalatoren.
English: Regarding its safety, Xoterna Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Danish: Vedrørende sikkerheden er Xoterna Breezhaler sammenligneligt med indacaterol og glycopyrronium, når disse anvendes hver for sig.
English: The active substances in Xoterna Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Danish: Begge aktive stoffer i Xoterna Breezhaler, indacaterol og glycopyrronium, udvider luftvejene og forbedrer vejrtrækningen ved KOL, men de virker på forskellige måder.