FrancophonIA/ELRC3.0 huggingface dataset:
English: Seresto is an antiparasitic collar containing 10% imidacloprid and 4.5% flumethrin.
Danish: Seresto er et antiparasitært halsbånd, som indeholder 10 % imidacloprid og 4,5 % flumetrin.
English: Seresto, sometimes under its associated name Foresto, is authorised in nearly all EU/EEA Member States.
Danish: Seresto, sommetider under det relaterede navn Foresto, er tilladt i næsten alle EU/EEAmedlemsstaterne.
English: What is Seresto?
Danish: Hvad er Seresto?
English: What are the conclusions of the CVMP?
Danish: Hvilke konklusioner traf Udvalget for Veterinærlægemidler?
English: Questions and answers on Seresto and its associated name Foresto
Danish: Spørgsmål og svar om Seresto og det relaterede navn Foresto
English: Because these Member States were not able to reach an agreement, the German Federal Office of Consumer Protection and Food Safety (BVL) referred the matter to the CVMP for arbitration on 18 August 2017.
Danish: Da disse medlemsstater ikke kunne nå til enighed, indbragte det tyske forbundsagentur for forbrugerbeskyttelse og fødevaresikkerhed (BVL) sagen for Udvalget for Veterinærlægemidler den 18. august 2017 med henblik på en voldgift.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks and lice in dogs and cats, and provides indirect protection against the diseases babesiosis and ehrlichiosis, which can be transmitted to dogs by ticks.
Danish: Det er beregnet til at behandle og forebygge infestationer med lopper, flåter og lus hos hunde og katte samt beskytter indirekte mod sygedommene babesiose og ehrlichiose, som kan overføres til hunde via flåter.
English: Questions and answers on Seresto and its associated name Foresto EMA/392857/2018
Danish: Spørgsmål og svar om Seresto og det relaterede navn Foresto EMA/468954/2018
English: The proposed new indication was against the disease leishmaniosis, which is caused by the parasite Leishmania infantum and transmitted to dogs by sand flies.
Danish: Den foreslåede nye indikation var mod sygedommen Leishmaniasis, der forårsages af parasitten Leishmania infantum, og som overføres til hunde via kvægmyg.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto.
Danish: Den 15. februar 2018 afsluttede Det Europæiske Lægemiddelagentur ("agenturet") en voldgift vedrørende Seresto og det relaterede navn Foresto.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the efficacy of Seresto in the reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months had been sufficiently demonstrated and therefore the variation to the marketing authorisation can be approved in all concerned Member States.
Danish: På baggrund af evalueringen af de aktuelt tilgængelige data og udvalgets videnskabelige diskussion besluttede Udvalget for Veterinærlægemidler, at virkningen af Seresto med hensyn til at reducere risikoen for infektion med Leishmania infantum som følge af overførelse via kvægmyg i op til otte måneder var blevet tilstrækkeligt påvist, og at ændringen af markedsføringstilladelsen derfor kan godkendes i alle de berørte medlemsstater.
English: The grounds for the referral were the concerns of the UK that the efficacy of the product in repelling sand flies had not been sufficiently demonstrated.
Danish: Begrundelsen for indbringelsen var Det Forenede Kongeriges betænkeligheder ved, at produktets evne til at fordrive kvægmyg ikke i tilstrækkelig grad var påvist.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Danish: Agenturets Udvalg for Veterinærlægemidler besluttede, at ændringen af markedsføringstilladelsen for Seresto med henblik på at tilføje en ny indikation kan godkendes.
English: The European Commission issued an EU-wide legally binding decision to implement the CVMP recommendations on Seresto on 25 May 2018.
Danish: Europa-Kommissionen traf den 25. maj 2018 en juridisk bindende afgørelse med gyldighed i hele EU om at gennemføre anbefalingerne fra Udvalget for Veterinærlægemidler om Seresto.
English: However, the CVMP recommended inclusion of the statement, in the product information of Seresto, that the demonstrated repellent efficacy against sand flies was variable.
Danish: Dog anbefalede Udvalget for Veterinærlægemidler, at udtalelsen om, at den påviste evne til at fordrive kvægmyg var variabel, skulle medtages i produktinformationen for Seresto.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vial (multipack)
Danish: Hætteglas 10 ml (3,5 mg/ml) 5 (5 x 1) hætteglas (multipakning)
English: blister (aclar/alu) 56 tablets blister (aclar/alu);card
Danish: Oral anvendelse blister (aclar/alu) 56 tabletter
English: Pack size bottle (HDPE)
Danish: Oral anvendelse beholder (HDPE) 56 tabletter
English: Route of Administration
Danish: 28 tabletter
English: 4 (1x4) vials
Danish: 4 (1x4) hætteglas
English: 150 mg/ml Solution for injection
Danish: 150 mg/ml Injektionsvæske Subkutan anvendelse hætteglas (glas) 1 ml
English: EMA/379048/2013 EMEA/H/C/002349
Danish: Den 27. juni 2013 EMA/442971/2013 EMEA/H/C/002349
English: What is IXinity?
Danish: Hvad er IXinity?
English: It was expected to be available as a powder and solvent to make up a solution for injection (500, 1,000 and 1,500 units).
Danish: Det forventedes leveret som et pulver og solvens til fremstilling af en injektionsvæske, opløsning (500, 1 000 og 1 500 enheder).
English: This causes problems with blood clotting, leading to bleeding into the joints, muscles and internal organs.
Danish: Dette medfører problemer med blodets koagulation, så der opstår blødning i led, muskler og indre organer.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med IXinity og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The company expressed its intention to re-apply for marketing authorisation once the data were available.
Danish: Virksomheden oplyste, at den havde til hensigt igen at ansøge om markedsføringstilladelse, når disse data forelå.
English: What was IXinity expected to be used for?
Danish: Hvad forventedes IXinity anvendt til?
English: On 13 June 2013, Cangene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prevention of bleeding in patients with haemophilia B.
Danish: Den 13. juni 2013 meddelte Cangene Europe Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for IXinity til behandling og forebyggelse af blødning hos patienter med hæmofili B.
English: Although the studies had shown evidence of the effectiveness of IXinity, they had also revealed that patients developed an unexpectedly high level of antibodies against proteins from the cells used to make IXinity, which were also present in the medicine.
Danish: Skønt undersøgelserne havde vist, at IXinity var effektivt, havde de også vist, at patienterne udviklede et uventet højt niveau af antistoffer mod proteiner fra de celler, der blev anvendt til fremstilling af IXinity, og som også fandtes i lægemidlet.
English: Effectiveness was measured by the patients' assessment of how well bleeding was controlled, and by the number of bleeding episodes that occurred while receiving the medicine.
Danish: Virkningen blev bedømt på patienternes vurdering af, hvor godt blødningen var kontrolleret, og på det antal blødningsepisoder, der forekom, mens de var i behandling med lægemidlet.
English: How is IXinity expected to work?
Danish: Hvordan forventes IXinity at virke?
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med IXinity?
English: The company informed the CHMP that patients currently included in clinical trials would continue to receive IXinity and would be switched to the refined product once revised rules for the conduct of the trials had been approved.
Danish: Virksomheden oplyste til CHMP, at patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser, fortsat vil få IXinity og vil overgå til det forbedrede produkt, når ændrede regler for udførelsen af undersøgelserne er godkendt.
English: IXinity was expected to be used to prevent and treat bleeding episodes in patients at least 12 years of age with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Danish: IXinity forventedes anvendt til forebyggelse og behandling af blødningsepisoder hos patienter over 12 år med hæmofili B (en arvelig blødningsforstyrrelse, der skyldes mangel på faktor IX).
English: The company refined the manufacturing process for IXinity to remove these proteins, but it was not clear if the refined medicine would act in the same way as the original product in the studies, and the CHMP recommended further study in patients.
Danish: Virksomheden forbedrede fremstillingsprocessen for IXinity for at fjerne disse proteiner, men da det ikke var klart, om det forbedrede produkt ville virke på samme måde som det oprindelige produkt anvendt i undersøgelserne, anbefalede CHMP en ny undersøgelse hos patienter.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that IXinity could not have been approved for the prevention and treatment of bleeding episodes in patients with haemophilia B.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at IXinity ikke kunne være blevet godkendt til forebyggelse og behandling af blødningsepisoder hos patienter med hæmofili B.
English: IXinity is a medicine that contains the active substance trenonacog alfa (recombinant human factor IX).
Danish: IXinity er et lægemiddel, der indeholder det aktive stof trenonacog alfa (rekombinant human faktor IX).
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its decision to withdraw the application was based on the fact that the additional data required to address the CHMP's concerns could not be made available within the regulatory timeframe.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi det inden for den forskriftsmæssige frist ikke var muligt at fremskaffe de nødvendige supplerende data til besvarelse af CHMP's spørgsmål.
English: The company presented the results of studies involving 42 patients with moderate or severe haemophilia B who were given IXinity for treatment or prevention of bleeding, including some patients undergoing surgery.
Danish: Virksomheden fremlagde resultaterne af undersøgelser med 42 patienter, der havde moderat eller svær hæmofili B, og som fik IXinity til behandling eller forebyggelse af blødning.
English: Patients with haemophilia B do not have sufficient levels of factor IX, a protein in the blood that helps it to clot normally.
Danish: Patienter med hæmofili B har ikke tilstrækkeligt med faktor IX, et protein i blodet, der medvirker til blodets normale koagulation (størkning).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that based on the currently available data the balance of the benefit and risks of the refined IXinity product was negative.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at forholdet mellem fordele og risici for det forbedrede produkt IXinity var negativt, baseret på de foreliggende oplysninger.
English: The active substance in IXinity is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce the clotting factor.
Danish: Det produceres ved dyrkning af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere koagulationsfaktoren.
English: The active substance in IXinity, trenonacog alfa, is a form of human factor IX that replaces the missing factor IX in the blood, temporarily controlling the bleeding disorder.
Danish: Det erstatter den manglende faktor IX i blodet, så blødningsforstyrrelsen midlertidigt er under kontrol.
English: In a single-dose clinical study, radiolabeled (
Danish: I et klinisk enkelt-dosisstudie blev radioaktivt mærket (
English: Both regimens were welltolerated by these patients.
Danish: Begge regimer er veltålte hos disse patienter.
English: 2 Week Follow-up e
Danish: 2 ugers opfølgning e
English: Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Danish: Dato for første tilladelse: 20. september 2007 Dato for seneste fornyelse: 28. august 2017
English: You should not be given a double dose by doctor.
Danish: Du må ikke få en dobbeltdosis af lægen.
English: C. albicans Non-albicans species
Danish: C. albicans Non-albicans arter
English: Between group difference ( 95% CI)
Danish: Forskelle mellem grupper (95% CI)
English: This medicine contains fructose (a type of sugar).
Danish: Denne medicin indeholder fructose (en slags sukker).
English: Duration of treatment should be based on the patient's clinical response.
Danish: Behandlingens varighed afhænger af patientens kliniske respons.
English: The expiry data refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Danish: Størstedelen af patienterne havde Apache II-score 20, og meget få var neutropene.
English: Most clinical cases involve caspofungin treatment.
Danish: De fleste kliniske tilfælde involverer behandling med caspofungin.
English: 98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Danish: 98.3% konfidensinterval, justeret post-hoc for gentagne sammenligninger ved sekundære tidspunkter.
English: Anidulafungin has negligible renal clearance (<1%).
Danish: Anidulafungin har en ubetydelig renal clearance (<1 %).
English: Anidulafungin is extensively bound (>99%) to human plasma proteins.
Danish: Anidulafungin er i udstrakt grad (>99 %) bundet til humane plasmaproteiner.
English: A successful global response required clinical improvement and microbiological eradication.
Danish: Et succesfuldt globalt respons krævede klinisk bedring og mikrobiologisk eradikation.
English: A total of 46 patients were included in the analysis.
Danish: I alt 46 patienter blev inkluderet i analysen.
English: These medicines are used to treat serious fungal infections.
Danish: Denne medicin bruges til at behandle alvorlige svampeinfektioner.
English: ECALTA is not dialysable.
Danish: ECALTA er ikke dialyserbart.
English: For the clinical relevance of these findings see “Clinical efficacy and safety.”
Danish: Den kliniske relevans af disse fund kan ses under ”Klinisk virkning og sikkerhed”.
English: In the presence of ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Danish: Ved tilstedeværelse af ECALTA vil svampeceller have ufuldstændige eller defekte cellevægge, som gør dem svage eller ude af stand til at vokse.
English: It is unknown whether anidulafungin is excreted in human milk.
Danish: Det er ukendt, om anidulafungin udskilles i human mælk.
English: This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Danish: Det vil tage mindst 1½ time for vedligeholdelsesdosis og 3 timer for startdosis.
English: The clearance of anidulafungin is about 1 l/h.
Danish: Clearance af anidulafungin er ca 1 l/time.
English: A total of 129 patients were included in the analysis.
Danish: I alt 129 patienter blev inkluderet i analysen.
English: The clinical relevance of this is unknown.
Danish: Den kliniske betydning heraf kendes ikke.
English: Intra-abdominal Data presented for patients with a single baseline pathogen.
Danish: Intra-abdominal Data for patienter med et enkelt patogen ved baseline.
English: Mortality Anidulafungin Fluconazole
Danish: Mortalitet Anidulafungin Fluconazol
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Some of these side effects will be noted by your doctor while monitoring your response and condition.
Danish: Nogle af disse bivirkninger vil blive registreret af din læge, mens din tilstand og reaktion på behandlingen overvåges.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: K VALITATIV OG KVANTITATIV SAMMENSÆTNING
English: A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Danish: Der blev observeret en lav interindividuel variation i systemisk eksponering (variationskoefficient på omtrent 25 %).
English: ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: ECALTA bør ikke anvendes under graviditeten medmindre fordelen for moderen er større end den potentielle risiko for fostret.
English: Contact your doctor immediately if you become pregnant while taking ECALTA.
Danish: Kontakt straks lægen, hvis du bliver gravid, mens du tager ECALTA.
English: The majority of patients had candidemia only.
Danish: De fleste af patienterne havde kun candidæmi.
English: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Danish: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Andre Candida-arter
English: The mean APACHE II score was 14.9 (range, 2 - 44).
Danish: Den gennemsnitlige APACHE II-score var 14,9 (spredning 2-44).
English: There are no data from the use of anidulafungin in pregnant women.
Danish: Der er ingen data fra anvendelse af anidulafungin til gravide kvinder.
English: The table below provides the volumes required for each dose.
Danish: I tabellen nedenfor er angivet, hvor meget volumen der kræves til hver dosis.
English: Total reconstituted volume
Danish: Total rekonstitueret volumen
English: If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
Danish: Hvis disse reaktioner opstår, skal anidulafungin seponeres og passende behandling iværksættes.
English: Dilution requirements for ECALTA administration
Danish: Krav til fortynding ved ECALTA-administration
English: As with any overdose, general supportive measures should be utilised as necessary.
Danish: Som for enhver overdosering er behandling generelt understøttende efter behov.
English: Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
Danish: 256 patienter i alderen 16-91 år blev randomiseret til behandling, og fik mindst én dosis af studiemedicinen.
English: ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
Danish: ECALTA vil altid blive blandet og givet til dig af en læge eller sygeplejerske (der findes mere information om blanding i slutningen af denne information under ”Følgende oplysninger er tiltænkt læger og sundhedspersonale”).
English: In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
Danish: I patientstudier med gentagne doser var lægemiddelclearance en anelse hurtigere hos mænd (ca. 22 %).
English: Of note, in vitro studies do not fully exclude possible in vivo interactions.
Danish: In vitro-forsøg udelukker ikke fuldt ud mulige in vivo-interaktioner.
English: Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections.
Danish: Behandling med ECALTA bør initieres af en læge med erfaring i behandling af invasive svampeinfektioner.
English: Global Response of Success at EOIVT
Danish: Succesfuldt globalt respons ved EOIVT
English: Additional Data in Neutropenic Patients
Danish: Yderligere data for neutropene patienter
English: ECALTA belongs to a group of medicines called echinocandins.
Danish: ECALTA hører til gruppen af medicin, der kaldes echinocandiner.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 ºC-8 ºC).
English: The majority of patients had candidemia only (84.8%; 39/46).
Danish: De fleste af patienterne havde kun candidæmi (84,8 %; 39/46).
English: 6 Week Follow-up Calculated as anidulafungin minus fluconazole With or without concurrent candidaemia c
Danish: 6 ugers opfølgning Kalkuleret som anidulafungin minus fluconazol Med eller uden samtidig candidæmi c
English: ECALTA contains the active substance anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis.
Danish: ECALTA indeholder det aktive stof anidulafungin og bruges hos voksne til at behandle en type af svampeinfektion i blodet eller andre indre organer, som kaldes invasiv candidiasis.
English: Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Danish: Global succes i MITT-populationen: primære og sekundære endemål Anidulafungin Fluconazol
English: Treatment was administered for at least 14 and not more than 42 days.
Danish: Behandlingen blev givet i mindst 14 dage og ikke mere end 42 dage.
English: ECALTA prevents normal development of fungal cell walls.
Danish: ECALTA hindrer normal udvikling af svampens cellevæg.
English: Twenty one (16.3%) had concomitant candidemia.
Danish: 21 patienter (16,3 %) havde samtidig candidæmi.
English: Patients who received at least one dose of study medicinal products and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intentto-treat (MITT) population.
Danish: De patienter, der fik mindst én dosis af studielægemidlet, og som havde en positiv dyrkning for Candida-arter fra et normalt sterilt sted, før de indgik i studiet, blev inkluderet i den modificerede intent-to-treat (MITT)-population.
English: Anaphylactic reactions, including shock, were reported with the use of anidulafungin.
Danish: Anafylaktiske reaktioner, herunder shock, er rapporteret efter brug af anidulafungin.
English: Patients were followed for six weeks beyond the end of all therapy.
Danish: Patienterne blev fulgt i 6 uger efter afslutning af al behandling.
English: Hypersensitivity to other medicinal products of the echinocandin class.
Danish: Overfølsomhed over for andre lægemidler af echinocandin-klassen.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: ECALTA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There are no special requirements for disposal.
Danish: Ingen særlige forholdsregler vedrørende destruktion.
English: The reconstituted solution has a pH of 3.5 to 5.5.
Danish: pH i den rekonstituerede opløsning er 3,5-5,5.