FrancophonIA/ELRC3.0 huggingface dataset:
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 får vaccinen, opfatter immunsystemet de svækkede eller dræbte virus og de svækkede bakterier som "fremmede" og danner antistoffer mod dem.
English: The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine.
Danish: Det vigtigste mål for effektiviteten var blodets indhold af antistoffer mod virus og bakterier i vaccinen.
English: If self-injection does occur in these people, tell the doctor that self-injection with a living 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: Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Danish: Purevax RCPCh anvendes til at vaccinere katte fra 8-ugers alderen mod følgende sygdomme:
English: In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination.
Danish: Feltundersøgelserne af Purevax RCPCh vedrørte basisvaccinationsplanen (2 injektioner med 3-4 ugers mellemrum) og boostervaccinationen.
English: Purevax RCPCh should not be used in pregnant cats.
Danish: Purevax RCPCh bør ikke anvendes hos drægtige katte.
English: Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Danish: Purevax RCPCh 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 has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus.
Danish: Effektiviteten af Purevax RCPCh er undersøgt under laboratorieforhold i flere undersøgelser, hvor kattene blev vaccineret og inficeret med herpesvirus, calicivirus, C. felis eller parvovirus.
English: Purevax RCPCh is a vaccine.
Danish: Purevax RCPCh er en vaccine.
English: Purevax RCPCh is a veterinary vaccine that contains:
Danish: Purevax RCPCh er en veterinær vaccine, der indeholder:
English: Other information about Purevax RCPCh:
Danish: Andre oplysninger om Purevax RCPCh:
English: For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Purevax RCPCh fremgår af indlægssedlen.
English: In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above.
Danish: Purevax RCPCh er påvist at beskytte mod ovennævnte sygdomme under laboratoriebetingelser.
English: Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia.
Danish: Purevax RCPCh indeholder små mængder svækkede eller dræbte virus og bakterier, der forårsager felin rhinotracheitis, calicivirose, klamydia og panleukopeni.
English: Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine
Danish: Felin viral rhinotracheitis-, felin klamydia-, felin panleukopeni- (levende, svækket) og felin calicivirose- (inaktiveret) vaccine
English: What is the risk associated with Purevax RCPCh?
Danish: Hvilken risiko er der forbundet med Purevax RCPCh?
English: Why has Purevax RCPCh been approved?
Danish: Hvorfor blev Purevax RCPCh godkendt?
English: What is Purevax RCPCh?
Danish: Hvad er Purevax RCPCh?
English: How has Purevax RCPCh been studied?
Danish: Hvordan blev Purevax RCPCh undersøgt?
English: What is Purevax RCPCh used for?
Danish: Hvad anvendes Purevax RCPCh til?
English: How does Purevax RCPCh work?
Danish: Hvordan virker Purevax RCPCh?
English: What benefit has Purevax RCPCh shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax RCPCh?
English: A further study was carried out in 15 female patients.
Danish: Der blev udført en yderligere undersøgelse af 15 kvindelige patienter.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Danish: Da virksomheden havde fremlagt de yderligere oplysninger, som man havde anmodet om, blev de ”særlige omstændigheder” ophævet den 20. juli 2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Replagal den 3. august 2001.
English: The effect of giving doses weekly rather than every two weeks was also investigated.
Danish: Virkningen af ugentlige doser snarere end doser givet hver anden uge blev også undersøgt.
English: Other information about Replagal
Danish: Andre oplysninger om Replagal
English: This is a summary of the European public assessment report (EPAR) for Replagal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Replagal.
English: The full EPAR for Replagal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Replagal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Danish: Replagal er også blevet evalueret i yderligere undersøgelser, der omfattede 38 børn i alderen 7 år og opefter.
English: Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes.
Danish: Replagal indgives som en infusion i løbet af 40 minutter én gang hver anden uge i doser på 0,2 mg pr. kilogram kropsvægt.
English: These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Danish: Disse omfatter kulderystelser, hovedpine, kvalme, pyreksi (feber), smerter og ubehag, rødmen og træthed, og de er sjældent alvorlige.
English: For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Replagal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
Danish: Hos børn, som modtog Replagal, var der ingen uventet forøgelse af hjertets masse, og Gb3-niveauerne i blodet blev formindsket.
English: The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Danish: De hyppigste bivirkninger ved Replagal (som optræder hos flere end 1 ud af 10 patienter) er infusionsrelaterede reaktioner.
English: Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Danish: Replagal blev oprindeligt godkendt under "særlige omstændigheder", da der på godkendelsestidspunktet kun forelå sparsomme oplysninger som følge af sygdommens sjældenhed.
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 Replagal.
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 Replagal skal anvendes.
English: Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Danish: Replagal reducerede den venstre ventrikelmasse med gennemsnitlig 11,5 g, mens patienter, som modtog placebo, oplevede en stigning i venstre ventrikelmasse på 21,8 g. Virkningerne hos kvindelige patienter viste sig at være sammenlignelige med resultaterne hos mandlige patienter, og der var ingen fordele forbundet med ugentlige doseringer frem for med standarddoseringer.
English: The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Danish: Det aktive stof i Replagal, agalsidase alfa, er en kopi af det humane enzym og er fremstillet ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi", dvs. det fremstilles af celler, som har modtaget et gen (DNA), der sætter dem i stand til at producere enzymet.
English: Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Danish: Replagal blev sammenlignet med placebo (en uvirksom behandling) i to hovedundersøgelser, der omfattede i alt 40 mandlige patienter.
English: People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Danish: Personer med Fabrys sygdom kan have en lang række tegn og symptomer, herunder alvorlige lidelser såsom nyresvigt, hjerteproblemer og slagtilfælde.
English: The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Replagal opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: Replagal is medicine that contains the active substance agalsidase alfa.
Danish: Replagal er et lægemiddel, der indeholder det aktive stof agalsidase alfa.
English: Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Danish: Patienter med Fabrys sygdom mangler enzymet alfa-galactosidase A. Dette enzym nedbryder normalt et fedtstof, som hedder globotriaosylceramid (Gb3 eller GL-3).
English: After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Danish: Efter seks måneders behandling nedsatte Replagal patienternes smerter i væsentlig grad sammenlignet med placebo.
English: Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Danish: Replagal er designet til at erstatte det humane enzym alfa-galactosidase A, som personer med Fabrys sygdom mangler.
English: The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
Danish: CHMP besluttede, at for patienter med Fabrys sygdom kan behandling med Replagal give kliniske fordele på lang sigt.
English: The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Danish: I den første undersøgelse målte man Replagals effekt på smerter, og i den anden undersøgelse målte man effekten på den venstre ventrikelmasse (hjertemusklen), et mål for mængden af Gb3 i hjertecellerne.
English: For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Replagal fremgår af indlægssedlen.
English: The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Danish: Substitutionsenzymet hjælper med at nedbryde Gb3 og forhindrer det i at hobe sig op i cellerne.
English: What is the risk associated with Replagal?
Danish: Hvilken risiko er der forbundet med Replagal?
English: Why has Replagal been approved?
Danish: Hvorfor blev Replagal godkendt?
English: Replagal is an enzyme replacement therapy.
Danish: Replagal er en enzymsubstitutionsbehandling.
English: It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Danish: Det fås som et koncentrat til fremstilling af en opløsning til infusion (drop i en vene).
English: If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Danish: Hvis enzymet mangler, kan Gb3 ikke nedbrydes, og det hober sig op i cellerne, f.eks. nyrecellerne.
English: Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Danish: Replagal bør kun gives af en læge med erfaring i behandling af patienter med Fabrys sygdom eller andre arvelige stofskiftesygdomme.
English: How has Replagal been studied?
Danish: Hvordan blev Replagal undersøgt?
English: What is Replagal?
Danish: Hvad er Replagal?
English: Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Danish: Replagal anvendes til behandling af patienter, som lider af Fabrys sygdom, en sjælden arvelig sygdom.
English: What benefit has Replagal shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Replagal?
English: What is Replagal used for?
Danish: Hvad anvendes Replagal til?
English: How is Replagal used?
Danish: Hvordan anvendes Replagal?
English: How does Replagal work?
Danish: Hvordan virker Replagal?
English: Content (concentrati on)
Danish: Indhold (koncentrati on
English: Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
Danish: Da der ikke kunne opnås enighed, indbragte CMD(h) sagen for CHMP.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BLEOMYCIN PHARMACHEMIE AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF BLEOMYCIN PHARMACHEMIE OG TILKNYTTEDE NAVNE (SE BILAG I)
English: In the Netherlands bleomycin is currently approved for the following indications:
Danish: I Nederlandene er bleomycin på nuværende tidspunkt godkendt til følgende indikationer:
English: The CHMP assessed the available data in order to establish whether the two indications can be supported.
Danish: CHMP vurderede de fremlagte oplysninger for at fastslå, hvorvidt de to indikationer kan understøttes.
English: In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/risk balance is positive.
Danish: Sluttelig konkluderede CHMP, at virkningen opvejer produktets toksicitet, og at benefit/risk-forholdet er positivt.
English: The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
Danish: Ansøgningen for Bleomycin Pharmachemie er indsendt som generisk ansøgning på baggrund af den markedsføringstilladelse, der blev udstedt for referenceproduktet i Nederlandene den 18. november 1997.
English: Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af markedsførings tilladelse
English: GROUNDS FOR OPINION
Danish: BEGRUNDELSE FOR UDTALELSE
English: The CHMP noted that bleomycin is in clinical use since the 1960ies, thereby explaining the lack of a clinical development programme.
Danish: CHMP bemærkede, at bleomycin har været anvendt klinisk siden 1960'erne, hvilket forklarer det manglende kliniske udviklingsprogram.
English: The same is applicable for the indication penile cancer; the indication is supported by reports suggesting a modest efficacy for this disease.
Danish: Det samme gælder for indikationen peniscancer, hvor indikationen understøttes af rapporter, der antyder en beskeden virkning for denne sygdom.
English: The CHMP therefore considered the indication to be acceptable.
Danish: CMPH vurderer derfor, at indikationen er acceptabel.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJE, ANSØGERE, I MEDLEMSSTATERNE
English: Because the benefit/risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Danish: Da vurderingen af benefit/risk-forholdet ved disse indikationer var negativ for det oprindelige produkt, og da indikationerne som følge heraf blev fjernet fra listen over indikationer for alle bleomycinprodukter i Tyskland, blev indikationerne betragtet som nye indikationer, og Tyskland skønnede, at de forelagte oplysninger var utilstrækkelige til, at der kunne udstedes en markedsføringstilladelse for de foreslåede nye indikationer.
English: The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN: Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Danish: CMPH bemærkede, at bleomycin stadig anvendes og også nævnes i aktuelle behandlingsvejledninger i Europa og Nordamerika, eksempelvis i forbindelse med pladecellekarcinomer i hoved og hals: "Practice Guidelines in Oncology", v. 2, 2008 (HCCN, USA), "CCO (Cancer Care Ontario) Formulary", revideret i 2006/2007, samt "Guidelines on penile cancer" (marts 2004) fra European Association of Urology.
English: The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/or radiation therapy.
Danish: Behandling med bleomycin finder næsten altid sted i kombination med andre cytostatiske midler og/eller strålebehandling.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Den gældende tekst til produktresume, etikettering og indlægsseddel er de endelige versioner der er fastlagt ved behandling i koordinationsgruppen.
English: In a lower degree bleomycin also affects the RNA and protein synthesis.
Danish: Bleomycin påvirker desuden i mindre grad RNA- og proteinsyntese.
English: Although the applicant was willing to remove the indications objected to by the objecting CMS, the RMS and the other positive CMSs were in favour of retaining these indications.
Danish: Selv om ansøgeren var villig til at fjerne de indikationer, der blev gjort indsigelser mod af den berørte medlemsstat, ønskede referencemedlemsstaten og andre positive berørte medlemsstater at bevare de pågældende indikationer.
English: Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, and adopted the totality of the proposed indications, for Bleomycin Pharmachemie:
Danish: CMPH mener derfor, at bleomycin stadig er et værdifuldt kemoterapeutisk lægemiddel, og vedtog samtlige foreslåede indikationer for Bleomycin Pharmachemie:
English: The effect of bleomycin rests on intercalation with single and double strands of DNA, resulting in single and double strand ruptures, which inhibit cell division, growth and DNA synthesis.
Danish: Bleomycins virkning ligger i indskydningen i enkelte og dobbelte DNA-strenge, således at der opstår sprængninger i disse strenge, hvilket hæmmer celledeling, vækst og DNA-syntese.
English: The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.
Danish: Kombinationen af bleomycin, vindesin, mitomycin C og cisplatin hos patienter med tilbagevendende og/eller metastatiske pladecellekarcinomer i livmoderhalsen er for nyligt blevet påvist at have en positiv virkning på overlevelse, og en fase II-undersøgelse påviste bleomycin som en del af et klinisk relevant alternativt behandlingsregime til cisplatin hos patienter med tilbagevendende livmoderhalskræft.
English: Therefore, despite overt toxicity and modest efficacy, the CHMP considered that bleomycin is a valuable treatment option for systemic treatment, if deemed necessary for these indications.
Danish: På trods af den åbenlyse toksicitet og den beskedne virkning vurderede CMPH derfor, at bleomycin er en værdifuld behandlingsmulighed for systemisk behandling, hvis det skønnes nødvendigt ved disse indikationer.
English: Although response rates are in general higher with bleomycin containing regimens, the added toxicity is readily acknowledged.
Danish: Selv om responsraterne generelt er højere for behandlinger, hvori bleomycin indgår, anerkendes den øgede toksicitet.
English: The CHMP considered that although bleomycin is not an obvious first line component for systemic treatment of cervical cancer, bleomycin remains a useful cytostatic drug that has to remain available to patients for this indication.
Danish: CMPH vurderede, at selv om bleomycin ikke er et oplagt førstevalg for systemisk behandling af livmoderhalskræft, er bleomycin stadig er nyttigt cytostatisk lægemiddel, der fortsat skal være til rådighed for patienter med denne indikation.
English: Regarding the indication in Head and Neck cancer, the CHMP is of the opinion that although bleomycin has obvious disadvantages related to its toxicity (pulmonitis, pulmonary fibrosis, stomatitis and skin changes), there is still a role for bleomycin in (neoadjuvant) treatment of the disease.
Danish: Hvad angår indikationen hoved-hals-cancer, er CHMP af den opfattelse, at selv om bleomycin har åbenlyse ulemper som følge af stoffets toksicitet (lungebetændelse, pulmonar fibrose, stomatitis og hudforandringer), er bleomycin stadig relevant i (neoadjuvant) behandling af sygdommen.
English: Regarding the indication in Epidermoid carcinoma of external genitalia, the CHMP noted that bleomycin is currently still in use in cervical cancer, and it was agreed that although the clinical efficacy is modest in this indication, as well as in penile cancer, several recent trials have illustrated the significance of bleomycin in these indications.
Danish: Hvad angår indikationen i epidermoide karcinomer i de ydre kønsdele, bemærkede CMPH, at bleomycin stadig anvendes ved livmoderhalskræft, og det blev besluttet, at selv om den kliniske virkning er beskeden ved denne indikation såvel som ved peniscancer, har adskillige nylige forsøg påvist bleomycins betydning ved anvendelse til disse indikationer.
English: Although bleomycin is currently not regarded as an essential component in the first line systemic treatment of SCCHN, it still constitutes a treatment option for (concomitant) chemotherapy, or in conjunction with RT, and can therefore not be considered obsolete for this indication.
Danish: Selv om blemycin på nuværende tidspunkt ikke betragtes som en vigtig del af den hyppigst foretrukne systemiske behandling af pladecellekarcinomer i hoved og hals, udgør det dog en behandlingsmulighed for (samtidig) kemoterapi eller i kombination med strålebehandling og kan derfor ikke anses for forældet for denne indikation.
English: In the combination therapy bleomycin is also of value, even though the evidence of the sole contribution of bleomycin is not assessable.
Danish: Også som kombinationsbehandling er bleomycin nyttig, selv om der ikke foreligger bevis for virkningen af bleomycin alene.