FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, fewer of the patients receiving Xolair had exacerbations than those receiving placebo.
Danish: Desuden optrådte der forværringer hos færre af de patienter, der fik Xolair, end hos dem, der fik placebo.
English: What is the risk associated with Xolair?
Danish: Hvilken risiko er der forbundet med Xolair?
English: In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.
Danish: I undersøgelsen hos patienter med svær allergisk astma var der ingen forskel mellem antallet af forværringer af astmaen hos Xolair- og placebogruppen, men Xolair medførte et tilsvarende fald i antallet af forværringer som i de tidligere undersøgelser.
English: It is available in two forms: as a vial containing a powder and solvent that are made up into a solution for injection; and as a prefilled syringe containing a solution for injection.
Danish: Det fås i to former, nemlig som et hætteglas med pulver og solvens, der blandes til en injektionsvæske, opløsning, og som en fyldt injektionssprøjte, der indeholder en injektionsvæske, opløsning.
English: Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.
Danish: Blandt de 235 børn, der blev behandlet med høje doser af inhalerede kortikosteroider plus en langtidsvirkende inhaleret beta2-agonist inden undersøgelsens start, var der i gennemsnit 0,4 forværringer i løbet af de første 24 ugers behandling hos dem, der fik Xolair, sammenlignet med 0,6 hos dem, der fik placebo.
English: Xolair has been studied in over 2,000 patients aged 12 years or over with allergic asthma in five main studies, including one study involving 482 patients with severe allergic asthma that was not controlled by conventional treatments.
Danish: Xolair blev undersøgt hos over 2000 patienter i alderen 12 år eller derover med allergisk astma i fem hovedundersøgelser, herunder en undersøgelse, som omfattede 482 patienter med svær allergisk astma, der ikke kunne kontrolleres med traditionel behandling.
English: For the full list of all side effects and restrictions with Xolair, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xolair fremgår af indlægssedlen.
English: The Committee concluded that, overall, there was a pattern of results in the studies of Xolair in asthma that show that the medicine is effective in treating severe allergic asthma.
Danish: Udvalget konkluderede, at resultaterne af undersøgelserne af Xolair hos patienter med astma generelt dannede et mønster, som viste, at lægemidlet var effektivt til behandling af svær allergisk astma.
English: By attaching to IgE, omalizumab ‘mops up' the free IgE circulating in the blood.
Danish: Ved at binde sig til IgE "indfanger" omalizumab det frie IgE i blodet.
English: Why has Xolair been approved?
Danish: Hvorfor blev Xolair godkendt?
English: For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks.
Danish: Til behandling af astma gives Xolair af en sundhedsfagligt uddannet person som en injektion under huden i skulderen eller låret hver anden eller fjerde uge.
English: Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Danish: Xolair anvendes til at opnå bedre kontrol med svær vedvarende astma, der skyldes allergi.
English: Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria.
Danish: Behandling med Xolair bør kun påbegyndes af en læge med erfaring i behandling af svær vedvarende astma eller kronisk spontan nældefeber.
English: The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight.
Danish: Dosis og doseringshyppighed for Xolair afhænger af indholdet af IgE i blodet og af legemsvægten.
English: This helps to reduce the symptoms of allergy, such as asthma attacks.
Danish: Derved lindres allergisymptomerne, såsom astmaanfald.
English: This means that when the body encounters an allergen, there is less IgE available to trigger an allergic reaction.
Danish: Det betyder, at der er mindre IgE til at udløse en allergisk reaktion, når kroppen møder et allergen.
English: What is Xolair?
Danish: Hvad er Xolair?
English: In the study in children with allergic asthma aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair.
Danish: I undersøgelsen hos børn mellem seks og 12 år med allergisk astma var antallet af forværringer lavere hos dem, der fik Xolair.
English: In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).
Danish: Hos patienter med kronisk spontan nældefeber er de hyppigste bivirkninger ved Xolair (som optræder hos mellem 1 og 10 patienter ud af 100) bihulebetændelse (sinusitis), hovedpine, ledsmerter (arthralgi), reaktioner på injektionsstedet og infektioner i de øvre luftveje (forkølelse).
English: In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo.
Danish: I undersøgelserne hos patienter med kronisk spontan nældefeber lindrede Xolair 300 mg kløesymptomerne med 4,5 til 5,8 points mere end placebo efter 12 ugers behandling.
English: In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients' existing treatment.
Danish: I alle undersøgelserne blev Xolair sammenlignet med placebo (en virkningsløs behandling), begge som tillægsbehandling til patientens eksisterende behandling.
English: Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash).
Danish: Xolair anvendes også til behandling af kronisk (langvarig) spontan nældefeber (kløende udslæt).
English: In all of the studies, Xolair was compared with placebo, when they were added to the patients' existing treatment.
Danish: I alle undersøgelserne blev Xolair sammenlignet med placebo, begge som tillægsbehandling til patientens eksisterende behandling.
English: • they must have had a positive skin test result for an allergy caused by an allergen (a stimulus that causes an allergy) in the air, such as house dust mites, pollen or mould;
Danish: • De skal have fremvist en positiv hudtest for et allergen (et stof, der fremkalder allergi) i luften,
English: For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks.
Danish: Til behandling af kronisk spontan nældefeber gives Xolair af en sundhedsfagligt uddannet person som en injektion under huden i skulderen eller låret i en dosis på 300 mg hver fjerde uge.
English: In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever).
Danish: De hyppigste bivirkninger hos børn mellem seks og 12 år (som optræder hos flere end 1 ud af 10 patienter) er hovedpine og feber.
English: In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching.
Danish: Hos børn på 12 år og derover med allergisk astma er de hyppigste bivirkninger ved Xolair (som optræder hos mellem 1 og 10 patienter ud af 100) hovedpine og reaktioner på injektionsstedet, herunder hævelse, rødme, smerte og kløe.
English: Omalizumab has been designed to attach to human IgE, which is produced in large quantities in patients with allergies and triggers an allergic reaction in response to an allergen.
Danish: Patienter med allergi producerer store mængder IgE, som udløser en allergisk reaktion ved påvirkning med et allergen.
English: In the studies in patients with allergic asthma aged 12 years or over, Xolair reduced the number of exacerbations by around half.
Danish: I undersøgelserne hos patienter på 12 år og derover med allergisk astma reducerede Xolair antallet af forværringer med ca. halvdelen.
English: What is Xolair used for?
Danish: Hvad anvendes Xolair til?
English: What benefit has Xolair shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xolair?
English: How has Xolair been studied?
Danish: Hvordan blev Xolair undersøgt?
English: In the treatment of asthma, Xolair is intended for long-term use.
Danish: Xolair er beregnet til langtidsbehandling ved behandling af astma.
English: How is Xolair used?
Danish: Hvordan anvendes Xolair?
English: How does Xolair work?
Danish: Hvordan virker Xolair?
English: This summary was last updated on 25 January 2008.
Danish: Dette sammendrag blev sidst ajourført den 25. januar 2008.
English: The vaccine should not be handled by people with a weak immune system.
Danish: Vaccinen bør ikke håndteres af personer med et svækket immunsystem.
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 faglige drøftelse (der ligeledes er en del af denne EPAR).
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Danish: Hvilke forholdsregler skal der træffes af den, der giver lægemidlet eller kommer i berøring med dyret?
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: En afvejning af fordele og risici ved lægemidlet findes i modul 6 af denne EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCCh til MERIAL den 23. februar 2005.
English: They included young and adult cats of various breeds, but not young kittens.
Danish: Undersøgelserne omfattede unge og voksne katte af forskellige racer, men ikke killinger.
English: The first injection should be given in cats aged at least eight weeks, with a second injection three to four weeks later.
Danish: Den første injektion bør gives til katte, der er mindst 8 uger gamle, og den anden injektion gives tre til fire uger senere.
English: When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection.
Danish: Når katten senere i livet eksponeres for disse vira, vil den enten ikke blive inficeret, eller infektionen vil være langt mindre alvorlig.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis.
Danish: Katten bør revaccineres for alle komponenterne et år efter det første vaccinationsprogram og derefter én gang årligt mod rhinotracheitis, calicivirose og chlamydiose.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCCH EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PUREVAX RCCH EPAR - sammendrag for offentligheden
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 forekomme en lokal reaktion på injektionsstedet med lidt smerte ved berøring, kløen eller hævelse; dette forsvinder i løbet af en til to uger.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Danish: Det primære mål for virkning var mængden af antistoffer i blodet mod viraene og bakterien i vaccinen.
English: If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Danish: Hvis katten har et højt niveau af maternelle antistoffer, bør man vente med den første vaccination, til katten er 12 uger gammel.
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 lægemidlet som beskrevet nedenfor.
English: Purevax RCCh is a vaccine.
Danish: Purevax RCCh er en vaccine.
English: In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Danish: Hvis man ved et uheld kommer til at injicere sig selv med medicinen, skal man omgående søge lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them.
Danish: Når en kat bliver vaccineret, opfatter immunsystemet de svækkede eller dræbte vira og den svækkede bakterie som fremmede og danner antistoffer mod dem.
English: Purevax RCCh is a vaccine containing the following active substances:
Danish: Purevax RCCh er en vaccine, der indeholder følgende aktive stoffer:
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Danish: • dræbte calicivirose antigener (FCV 431- og G1-stammer),
English: After Purevax RCCh has been made up, 1 ml is injected under the skin.
Danish: Efter at Purevax RCCh-suspensionen er klargjort, injiceres 1 ml under huden.
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: Det var ikke muligt at påvise en stigning i mængden af antistoffer mod Chlamydophila felis på grund af en for stor mængde af antistoffer i kattene ved undersøgelsens start.
English: Purevax RCCh should not be used in pregnant cats.
Danish: Purevax RCCh bør ikke anvendes til drægtige katte.
English: In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Danish: I feltundersøgelser af Purevax RCCh så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen (kun én injektion).
English: Other information about Purevax RCCh:
Danish: Andre oplysninger om Purevax RCCh:
English: Purevax RCCh contains small amounts of weakened or killed viruses and bacteria that cause the diseases listed above.
Danish: Purevax RCCh indeholder små mængder af svækkede eller dræbte vira samt bakterier, der fremkalder de ovenfor nævnte sygdomme.
English: Purevax RCCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Danish: Purevax RCCh består af en lyofilisat (frysetørret pille) og en opløsning, der blandes til en suspension til injektion.
English: Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Danish: Purevax RCCh anvendes til at vaccinere katte fra 8 uger og opefter mod følgende sygdomme:
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Danish: • svækket felin rhinotracheitis herpesvirus (FHV F2-stamme),
English: In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above.
Danish: I laboratorieundersøgelserne blev det påvist, at Purevax RCCh beskytter mod de sygdomme, der er angivet ovenfor.
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Danish: I feltundersøgelsen af basisvaccinationen fandt man en stigning i mængden af antistoffer mod felin rhinotracheitis herpesvirus og calicivirus-infektion.
English: • attenuated Chlamydophila felis (905 strain).
Danish: • svækket Chlamydophila felis (905-stamme).
English: The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis.
Danish: Virkningen af Purevax RCCh er undersøgt i adskillige laboratorieundersøgelser, hvor katte blev vaccineret og derefter inficeret med virulent herpesvirus, calicivirus eller Chlamydophila felis.
English: If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Danish: Hvis en sådan person alligevel kommer til at injicere sig selv med vaccinen, skal personen straks søge lægehjælp og fortælle, at han/hun er kommet til at injicere sig selv med en levende chlamydia-vaccine.
English: For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Purevax RCCh fremgår af indlægssedlen.
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Danish: • felin calicivirose, der er en influenzalignende sygdom med betændelse af munden forårsaget af en calicivirus,
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly.
Danish: I undersøgelsen af boostervaccinationen forblev mængden af antistoffer mod rhinotracheitis herpesvirus, calicivirus-infektion og Chlamydophila felis på et stabilt, højt niveau eller steg lidt.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RCCh er større end risiciene ved aktiv immunisering af katte fra 8 uger og opefter mod de førnævnte sygdomme.
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Danish: • felin viral rhinotracheitis, der er en influenzalignende sygdom, som skyldes en herpesvirus,
English: • chlamydiosis (a flu-like illness caused by the bacterium C. felis).
Danish: • chlamydiose, der er en influenzalignende sygdom fremkaldt af bakterien Chlamydophila felis.
English: It also helps to reduce viral excretion in case of calicivirus infection.
Danish: Vaccinen hjælper med at reducere symptomerne på sygdommene og med at reducere virusudskillelse i tilfælde af calicivirus-infektion.
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: Der kan af og til forekomme forbigående ligegyldighed med omgivelserne og appetitløshed samt forhøjet kropstemperatur, der varer i 1-2 dage.
English: What is the risk associated with Purevax RCCh?
Danish: Hvilken risiko er der forbundet med Purevax RCCh?
English: Why has Purevax RCCh been approved?
Danish: Hvorfor blev Purevax RCCh godkendt?
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: Når immunsystemet efterfølgende udsættes for viraene eller bakterien igen, vil det være i stand til hurtigere at danne antistoffer mod dem. Antistofferne hjælper med at beskytte mod de sygdomme, der fremkaldes af disse vira eller bakterien.
English: What is Purevax RCCh?
Danish: Hvad er Purevax RCCh?
English: How has Purevax RCCh been studied?
Danish: Hvordan blev Purevax RCCh undersøgt?
English: What is Purevax RCCh used for?
Danish: Hvad anvendes Purevax RCCh til?
English: How does Purevax RCCh work?
Danish: Hvordan virker Purevax RCCh?
English: What benefit has Purevax RCCh shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax RCCh?
English: Should this occur, use of this product should be discontinued.
Danish: Hvis dette sker, skal brugen af dette produkt ophøre.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen refererer til den sidste dag i den nævnte måned.
English: Organ/System (Frequency)
Danish: Organ/system (Hyppighed)
English: Psychic dependence may occur.
Danish: Psykisk afhængighed kan forekomme.
English: These occur most often up to several hours after ingesting the product.
Danish: Disse opstår hyppigst op til flere timer efter indtagelse af produktet.
English: Any new behavioural sign or symptom requires careful and immediate evaluation.
Danish: Ethvert nyt adfærdsmæssigt tegn eller symptom kræver omhyggelig og umiddelbar vurdering.
English: At least 71% of the orally-administered dose is absorbed.
Danish: Mindst 71% af den oralt indgivne dosis absorberes.
English: Extension beyond these periods should not take place without clinical re-evaluation of the patient.
Danish: Forlængelse udover denne periode bør ikke finde sted uden klinisk reevaluering af patienten.
English: • if you have myasthenia gravis (very weak or tired muscles).
Danish: • Hvis De har myasthenia gravis (meget svage eller trætte muskler)
English: Sleeping problems do not usually last long, and most people only need a short course of treatment.
Danish: Søvnproblemer varer sædvanligvis ikke længe, og de fleste mennesker behøver kun en kortvarig behandling.
English: • Rare cases of severe allergic reactions have been reported.
Danish: • Der er set sjældne tilfælde af allergiske reaktioner.
English: Be aware that such combinations may cause you to feel drowsy the next day.
Danish: Vær opmærksom på, at en sådan kombination kan få Dem til at føle Dem døsig næste dag.
English: Sonata will help you to sleep.
Danish: Sonata kan hjælpe Dem til at sove.
English: Alcohol and medicinal product abuse
Danish: Alkohol- og lægemiddelmisbrug
English: Just take your next capsule at the usual time, then go on as before.
Danish: Bliv ikke bekymret, bare tag næste kapsel på sædvanlig tid og fortsæt som hidtil.
English: • Use with extreme caution if you have ever been addicted to medicines or alcohol.
Danish: • Bruges med yderste forsigtighed, hvis De nogensinde har været afhængig af medicin eller alkohol.
English: In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
Danish: I disse undersøgelser blev patienterne diagnosticeret med primær (psykofysiologisk) søvnløshed.
English: These reactions are more likely to occur in the elderly.
Danish: Det er mere sandsynligt, at disse reaktioner vil forekomme hos ældre mennesker.
English: This includes medicines that can be bought without a prescription.
Danish: Dette gælder også medicin, som kan købes uden recept.
English: As with sleep-driving, patients usually do not remember these events.
Danish: Ligesom ved kørsel i medicinpåvirket tilstand husker patienterne normalt ikke disse hændelser.
English: Psychiatric and “paradoxical” reactions
Danish: Psykiatriske og ”paradoksale” reaktioner
English: No adverse effects on embryofetal development were observed in rabbits.
Danish: Der blev ikke observeret negative virkninger på den embryoføtale udvikling hos kaniner.
English: See also below under Depression and Psychiatric and “paradoxical” reactions
Danish: Se også nedenfor under Depression og Psykiatriske og ”paradoksale” reaktioner
English: Specific patient groups
Danish: Specifikke patientgrupper
English: Swallow the capsule(s) with a small glass of water.
Danish: Kapslen sluges sammen med et lille glas vand.