FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall the evidence from observational studies was in agreement with the randomised clinical trials (RCT) findings and it was therefore considered that the evidence continues to support the conclusion that treatment with ICS increases the risk of pneumonia in COPD patients.
Danish: Generelt var evidensen fra observationsstudier i overensstemmelse med resultaterne fra randomiserede kliniske forsøg, og evidensen betragtes derfor som fortsat at understøtte konklusionen, at behandling med ICS øger risikoen for lungebetændelse hos KOL-patienter.
English: A signal of increased risk of pneumonia in COPD patients with ICS-containing treatments was first identified in the TORCH study (Calverley et al., 2007) a large clinical study of three years treatment duration comparing the fluticasone propionate/salmeterol combination with its component parts and placebo in COPD patients.
Danish: Første gang der blev identificeret et tegn på øget risiko for lungebetændelse hos KOL-patienter med ICS-holdige behandlinger var under studiet TORCH (Calverley et al., 2007), et stort klinisk studie med tre års behandlingsvarighed, hvor kombinationen fluticasonpropionat/salmeterol blev sammenlignet med komponenterne hver for sig og placebo hos KOL-patienter.
English: No clinical trials directly examined the risk of pneumonia with ICSs head to head, and only indirect comparison in meta-analyses/systematic reviews or from observational studies is available, mainly between budesonide and fluticasone.
Danish: Der er ikke udført kliniske forsøg, hvor risikoen for lungebetændelse ved brug af ICS'er er undersøgt direkte, og der findes kun indirekte sammenligninger fra metaanalyser/systematiske vurderinger eller fra observationsstudier, hovedsageligt mellem budesonid og fluticason.
English: Although a number of common criticisms can be levelled at the studies included in these meta-analyses, including difficulties with the accurate identification of pneumonia (particularly pre-TORCH studies), variations in participant populations and comparators, differential withdrawal rates, and trials not specifically powered to detect pneumonia, a consistent association between ICS use and increased risk of pneumonia in COPD patients was seen across the meta-analyses.
Danish: Selvom der kan rettes en generel kritik mod de studier, der blev inkluderet i metaanalyserne, herunder problemstillinger med hensyn til nøjagtig identifikation af lungebetændelse (især før TORCH-studierne), forskelle i patientpopulationer og komparatorer, forskellige udtrædelsesrater og forsøg, som ikke specifikt havde til formål at påvise lungebetændelse, sås der en konsekvent forbindelse mellem brugen af ICS og en øget risiko for lungebetændelse hos KOL-patienter på tværs af metaanalyserne.
English: Overall, due to the variability in the clinical data and multiple uncertainties with study methodologies, there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among inhaled corticosteroid products.
Danish: Samlet set er der, på grund af forskellighederne i de kliniske data og adskillige usikkerheder forbundet med studiemetodikkerne, ikke nogen endegyldig klinisk evidens for forskelle klasserne imellem i størrelsen af risikoen forbundet med produkter med inhalerede kortikosteroidprodukter.
English: Symptoms of COPD include dyspnoea, chronic cough and chronic sputum production.
Danish: Symptomerne på KOL inkluderer dyspnø, kronisk hoste og kronisk opspyt.
English: • The PRAC also concluded that there is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS-containing products;
Danish: • PRAC konkluderede ligeledes, at der ikke fandtes endegyldig klinisk evidens for forskelle klasserne imellem med hensyn til størrelsen af risikoen blandt ICS-holdige produkter.
English: Finally, the PRAC considered the ICS dose-response effect or the influence of LABA and other concomitant medications on the risk of pneumonia in COPD patients.
Danish: Til sidst tog PRAC stilling til ICS-dosisresponsvirkningen eller indvirkningen af LABA og andre samtidige lægemidler på risikoen for lungebetændelse hos KOL-patienter.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for ICS-containing medicinal products indicated in the treatment of COPD.
Danish: Komitéen anbefaler som følge heraf, at betingelserne for markedsføringstilladelserne ændres for ICSholdige lægemidler indiceret til behandling af KOL.
English: The PRAC therefore concluded that pneumonia (in COPD patients) should be added as a common adverse drug reaction in the product information of all ICS-containing products and that for products with an existing Risk Management Plan, “increased risk of pneumonia in COPD patients” should be considered an Important Identified Risk.
Danish: PRAC konkluderede derfor, at lungebetændelse (hos KOL-patienter) bør tilføjes som en almindelig bivirkning i produktinformationen for alle lægemidler, som indeholder ICS, og at for produkter med en eksisterende risikostyringsplan bør "øget risiko for lungebetændelse hos KOL-patienter" betragtes som en vigtig identificeret risiko.
English: It was acknowledged that any risk of pneumonia with ICS should be considered in context, as pneumonia is an intrinsic comorbidity to COPD with certain predisposing factors making some COPD patients more susceptible to this risk than others.
Danish: Det blev bekræftet, at risikoen for lungebetændelse med ICS skal betragtes i sammenhæng, da lungebetændelse er en intrinsisk komorbiditet for KOL med visse prædisponerede faktorer, som gør nogle KOL-patienter mere udsatte end andre.
English: • The PRAC considered that some evidence of an increased risk of pneumonia with increasing steroid dose exists, although this has not been demonstrated conclusively across all studies;
Danish: • Det var PRAC's betragtning, at der fandtes nogen evidens for en øget risiko for lungebetændelse i takt med øget steroiddosis, selvom dette ikke blev påvist endegyldigt på tværs af alle studierne.
English: Some evidence suggests an increased risk of pneumonia with increasing steroid dose.
Danish: Der er nogen evidens, der indikerer en øget risiko for lungebetændelse ved højere steroiddoser.
English: In conclusion, the PRAC considered that the benefit-risk balance of ICS-containing products remained favourable, provided the proposed changes to the product information are implemented.
Danish: Det var i sidste instans PRAC's betragtning, at benefit/risk-forholdet for ICS-holdige produkter stadig er positivt, såfremt de anbefalede ændringer blev implementeret i produktinformationen.
English: Due to a paucity of data regarding the potential effects of other classes of medication prescribed for COPD, no conclusions could be drawn regarding the influence of concomitant medications on the risk of pneumonia in COPD patients.
Danish: Grundet mangel på data om de potentielle virkninger for andre klasser af lægemidler, der ordineres for KOL, blev der ikke draget nogen konklusion med hensyn til indvirkningen af samtidige lægemidler på risikoen for lungebetændelse hos KOL-patienter.
English: • The PRAC reviewed the data submitted by the marketing authorisation holders in relation to the increased risk of pneumonia in patients with COPD in association with ICS-containing medicinal products;
Danish: • PRAC gennemgik data indsendt af markedsføringstilladelsesindehaverne med hensyn til den øgede risiko for lungebetændelse hos patienter med KOL i forbindelse med ICS-holdige lægemidler.
English: Further, it was recognised that there are difficulties associated with the differential diagnosis of pneumonia or an exacerbation of COPD.
Danish: Det blev ligeledes erkendt, at det kan være svært at stille differentialdiagnosen lungebetændelse eller eksacerbation af KOL.
English: In view of the above, the Committee considers that the benefit-risk balance of ICS-containing medicinal products remains favourable in the treatment of COPD subject to the agreed amendments to the product information.
Danish: I lyset af ovenstående mener komitéen, at benefit-risk-forholdet for ICS-holdige lægemidler stadigt er gunstigt for behandling af KOL-patienter, under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: • The PRAC was of the view that the increased risk of pneumonia should be included in the product information of all ICS-containing products indicated in the treatment of COPD, with a warning for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Danish: • PRAC var af den mening, at den øgede risiko for lungebetændelse bør inkluderes i produktinformationen for alle ICS-holdige produkter, som er indiceret til behandling af KOL, med en advarsel til sundhedspersonale og patienter om, at være opmærksomme på muligheden for at udvikle lungebetændelse hos patienter med KOL, samtidig med at de overlappende symptomer for lungebetændelse og for eksacerbation af KOL tages med i betragtning.
English: To mitigate the risk of pneumonia, the PRAC considered that a warning should be included in the product information for healthcare professionals and patients to remain vigilant for the possible development of pneumonia in patients with COPD, taking into consideration the overlap of the symptoms of pneumonia with those of exacerbation of COPD.
Danish: For at nedsætte risikoen for lungebetændelse anbefaler PRAC, at der bør inkluderes en advarsel i produktinformationen til sundhedspersonale og patienter, om at være opmærksomme på muligheden for udvikling af lungebetændelse hos patienter med KOL, samtidig med at de overlappende symptomer for lungebetændelse og for eksacerbation af KOL tages med i betragtning.
English: • The PRAC concluded that the evidence provided supports a causal association between the use of ICS-containing products and an increased risk of pneumonia in COPD patients;
Danish: • PRAC konkluderede, at der var evidens for en kausal sammenhæng mellem brugen af ICSholdige produkter og en øget risiko for lungebetændelse hos KOL-patienter.
English: Since then other products containing ICS have been subject to review and it was considered that data on the risk of pneumonia with these products in the COPD population should be reviewed all together, so that the risk of pneumonia in this patient population could be further characterised.
Danish: Siden da har andre ICS-holdige produkter undergået et eftersyn, og det blev foreslået, at lave en samlet gennemgang af data om risikoen for lungebetændelse med disse produkter hos KOL-populationen.
English: Results from older meta-analyses and from observational studies were also variable, with some suggesting an increased risk of pneumonia with fluticasone compared to budesonide and others finding no difference.
Danish: Nogle resultater indikerede en øget risiko for lungebetændelse med fluticason sammenlignet med budesonid, og andre resultater indikerede ikke nogen forskel.
English: This document cannot replace a face-to-face discussion with your veterinarian.
Danish: Dette dokument kan ikke erstatte en personlig drøftelse med din dyrlæge.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every three years.
Danish: Katten bør revaccineres for alle komponenter ét år efter det første vaccinationsforløb, derefter hvert tredje år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCP on 23 February 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCP den 23. februar 2005.
English: The studies included young and adult cats of various breeds, but not young kittens.
Danish: Studierne omfattede unge og voksne katte af forskellige racer, men ikke små killinger.
English: It can also prevent death due to panleucopenia.
Danish: Derudover kan den forebygge dødelighed som følge af panleukopeni.
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 udsættes for sådanne virus, vil katten enten ikke blive inficeret eller få en langt mindre alvorlig infektion.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Danish: Derefter vil immunsystemet fremover kunne danne antistoffer hurtigere, når det møder de samme virus igen.
English: The antibodies will help to protect against the diseases caused by these viruses.
Danish: Antistofferne vil medvirke til at beskytte mod de sygdomme, der forårsages af disse virus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCP exceed the risks for the approved indications and recommended that Purevax RCP be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax RCP overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Purevax RCP.
English: When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘foreign' and makes antibodies against them.
Danish: Når en kat får vaccinen, opfatter immunsystemet de svækkede eller dræbte virus som "fremmede" og danner antistoffer mod dem.
English: In the field, the studies of Purevax RCP looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
Danish: Feltstudierne af Purevax RCP vedrørte den grundlæggende vaccinationsplan (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen (kun én injektion).
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses in the vaccine.
Danish: Virkningen blev hovedsageligt bedømt på blodets indhold af antistoffer mod virus i vaccinen.
English: Purevax RCP should not be used in pregnant cats.
Danish: Purevax RCP bør ikke anvendes hos drægtige katte.
English: Purevax RCP is used to vaccinate cats from the age of 8 weeks against:
Danish: Purevax RCP anvendes til at vaccinere katte fra 8-ugers alderen mod:
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 Lægemidler til Dyrs (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: • attenuated feline panleucopenia virus (PLI IV).
Danish: • svækket felin panleukopenivirus (PLI IV).
English: Purevax RCP is a vaccine.
Danish: Purevax RCP er en vaccine.
English: Purevax RCP is a veterinary vaccine that contains:
Danish: Purevax RCP er en veterinær vaccine, der indeholder:
English: The effectiveness of Purevax RCP has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or parvovirus.
Danish: Der blev set nærmere på virkningen af Purevax RCP under laboratorieforhold i flere studier, hvor kattene blev vaccineret og inficeret med smitsomme herpesvirus, calicivirus eller parvovirus.
English: For a full list of the side-effects reported with Purevax RCP, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Purevax RCP fremgår af indlægssedlen.
English: Purevax RCP is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Danish: Purevax RCP fås som en frysetørret pellet (et lyofilisat) med opløsningsvæske (solvens), som blandes til en suspension og gives ved indsprøjtning.
English: In laboratory conditions Purevax RCP was demonstrated to provide protection against the diseases listed above.
Danish: Purevax RCP er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser.
English: Purevax RCP contains small amounts of weakened or killed viruses that cause feline rhinotracheitis, calicivirosis and panleucopenia.
Danish: Purevax RCP indeholder små mængder svækkede eller dræbte virus, der forårsager felin rhinotracheitis, calicivirose og panleukopeni.
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 and feline panleucopenia remained stable at a high level or increased slightly.
Danish: I studiet vedrørende boostervaccination holdt indholdet af antistoffer mod infektion med rhinotracheitis herpesvirus, calicivirus-infektion og felin panleukopenivirus sig stabilt på et højt niveau eller steg en smule.
English: Feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Danish: Felin viral rhinotracheitisvaccine, felin panleukopenivaccine (levende, svækket) og felin calicivirosevaccine (inaktiveret)
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 feltstudiet af basisvaccination var der stigning i antistoffer mod felin rhinotracheitis herpesvirus, calicivirus-infektion og felin panleukopenivirus.
English: What is the risk associated with Purevax RCP?
Danish: Hvilken risiko er der forbundet med Purevax RCP?
English: Why has Purevax RCP been approved?
Danish: Hvorfor blev Purevax RCP godkendt?
English: Other information about Purevax RCP:
Danish: Andre oplysninger om Purevax RCP
English: What is Purevax RCP?
Danish: Hvad er Purevax RCP?
English: How has Purevax RCP been studied?
Danish: Hvordan blev Purevax RCP undersøgt?
English: What is Purevax RCP used for?
Danish: Hvad anvendes Purevax RCP til?
English: What benefit has Purevax RCP shown during the studies?
Danish: Hvilken fordel viser studierne, at der er ved Purevax RCP?
English: How does Purevax RCP work?
Danish: Hvordan virker Purevax RCP?
English: This summary was last updated in 12-2014.
Danish: Dette sammendrag blev sidst ajourført i 12-2014.
English: It is available as tablets (30 mg).
Danish: Det fås som tabletter (30 mg).
English: Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant.
Danish: Af de kvinder, som gennemførte hovedundersøgelsen, blev 2,1 % (26 ud af 1 241) gravide.
English: EllaOne can be taken at any time during the menstrual cycle.
Danish: EllaOne kan tages når som helst i en menstruationscyklus.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ellaOne on 15 May 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ellaOne den 15. maj 2009.
English: The medicine can be obtained without a prescription.
Danish: Lægemidlet udleveres uden recept.
English: The full EPAR for ellaOne can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for ellaOne findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This document is a summary of the European public assessment report (EPAR) for ellaOne.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ellaOne.
English: If the woman vomits within three hours of taking the medicine she should take another tablet.
Danish: Hvis kvinden kaster op inden for tre timer efter indtagelsen af lægemidlet, bør hun tage en ny tablet.
English: A risk management plan has been developed to ensure that ellaOne is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at ellaOne anvendes så sikkert som muligt.
English: EllaOne therefore prevented about three-fifths of the pregnancies.
Danish: EllaOne forebyggede således cirka 3/5 af de forventede graviditeter.
English: The main measure of effectiveness was the number of women who did not become pregnant.
Danish: Det primære mål for virkningen var antallet af kvinder, som ikke blev gravide.
English: This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect.
Danish: Det betyder, at det binder sig til de receptorer, som progesteron normalt binder sig til, hvilket forhindrer hormonet i at udøve dets virkning.
English: This is less than the 5.5% of women who would have been expected to become pregnant if they had not taken any contraceptive.
Danish: Det er mindre end de 5,5 % af de kvinder, som kunne være blevet gravide, hvis de ikke havde taget et svangerskabsforebyggende middel.
English: Other information about ellaOne:
Danish: Andre oplysninger om ellaOne
English: For the full list of all side effects and restrictions, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger fremgår af indlægssedlen.
English: For more information about treatment with ellaOne, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med ellaOne, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of ellaOne?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af ellaOne?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ellaOne.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan ellaOne skal anvendes.
English: EllaOne is a medicine that contains the active substance ulipristal acetate.
Danish: EllaOne er et lægemiddel, der indeholder det aktive stof ulipristalacetat.
English: This number was calculated from published pregnancy rates.
Danish: Antallet blev beregnet ud fra offentligt tilgængelige graviditetstal.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ellaOne, 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 ellaOne, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The CHMP decided that ellaOne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved ellaOne opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for ellaOne.
English: In one main study, ellaOne was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure.
Danish: I én hovedundersøgelse blev ellaOne givet til 1 533 kvinder (med en gennemsnitsalder på 24 år), som havde anmodet om akut svangerskabsforebyggelse mellem to og fem dage efter ubeskyttet samleje eller efter svigt af en svangerskabsforebyggende metode.
English: If ovulation has already occurred, ellaOne is no longer effective.
Danish: Hvis ægløsningen allerede har fundet sted, virker ellaOne ikke.
English: EPAR summary for the public ellaOne ulipristal acetate
Danish: EPAR - sammendrag for offentligheden ellaOne ulipristalacetat