FrancophonIA/ELRC3.0 huggingface dataset:
English: Desoxycortone pivalate is a synthetically produced steroid hormone very similar to the natural hormone aldosterone.
Danish: Desoxycortonpivalat er et syntetisk fremstillet steroidhormon, der i meget høj grad ligner det naturlige hormon aldosteron.
English: What is Zycortal and what is it used for?
Danish: Hvad er Zycortal, og hvad anvendes det til?
English: Desoxycortone pivalate
Danish: Zycortal desoxycortonpivalat
English: Why is Zycortal approved?
Danish: Hvorfor er Zycortal blevet godkendt?
English: Zycortal contains the active substance desoxycortone pivalate.
Danish: Zycortal indeholder det aktive stof desoxycortonpivalat.
English: Zycortal can only be obtained with a prescription.
Danish: Zycortal udleveres kun efter recept.
English: Zycortal is a veterinary medicine used to treat dogs with Addison's disease.
Danish: Zycortal er et veterinærlægemiddel, der anvendes til behandling af Addisons sygdom hos hunde.
English: Dogs with Addison's disease have insufficient levels of aldosterone in their blood and Zycortal is used to replace the missing hormone.
Danish: Hunde med Addisons sygdom har for lavt indhold af aldosteron i blodet, og Zycortal anvendes til at erstatte det manglende hormon.
English: What are the risks associated with Zycortal?
Danish: Hvilke risici er der forbundet med Zycortal?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zycortal, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zycortal, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: 90 days after start of treatment, 84% (92 out of 109) of Zycortal-treated dogs had improved clinical signs and normal sodium and potassium blood levels.
Danish: Hos de hunde, der blev behandlet med Zycortal, var der 90 dage efter behandlingen bedring i de kliniske symptomer hos 84 % (92 ud af 109), med normalt indhold af natrium og kalium i blodet.
English: Zycortal is used long-term to replace the missing aldosterone.
Danish: Zycortal anvendes som langtidsbehandling til erstatning for den manglende aldosteron.
English: For the full list of all side effects reported with Zycortal, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zycortal fremgår af indlægssedlen.
English: Addison's disease is a condition, known as hypoadrenocorticism, where the adrenal glands (located above the kidneys) do not produce enough of two steroid hormones, called cortisol and aldosterone.
Danish: Ved Addisons sygdom, der også kaldes binyrebarkinsufficiens, producerer binyrerne (som ligger over nyrerne) ikke tilstrækkeligt af de to steroidhormoner kortisol og aldosteron.
English: A corticosteroid medicine is likely to be needed, in addition, to replace the cortisol.
Danish: Desuden kræves der sandsynligvis et binyrebarkhormon til at erstatte kortisol.
English: If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the doctor.
Danish: I tilfælde af irritation skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: How is Zycortal used?
Danish: Hvordan anvendes Zycortal?
English: What benefits of Zycortal have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zycortal?
English: How does Zycortal work?
Danish: Hvordan virker Zycortal?
English: Zycortal is available as a prolonged-release suspension for injection.
Danish: Zycortal leveres som depotinjektionsvæske, suspension.
English: For more information about treatment with Zycortal, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Zycortal, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Zycortal, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Zycortal, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi on 4 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Versican Plus Pi den 4. juli 2014.
English: In the future, if the animals are exposed to this infection, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for denne infektion, vil immunsystemet reagere hurtigere.
English: The effectiveness of Versican Plus Pi was investigated in a field study involving 129 dogs.
Danish: Effektiviteten af Versican Plus Pi blev undersøgt i en feltundersøgelse med 129 hunde.
English: The vaccine is given to puppies from six weeks of age as an injection under the skin which is repeated three to four weeks later.
Danish: Vaccinen gives til hvalpe fra 6-ugers alderen ved en indsprøjtning under huden og gentages én gang 3-4 uger senere.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Danish: Den hyppigste bivirkning (som optræder hos mere end 1 ud af 100 hunde) ved Versican Plus Pi er kortvarig hævelse på op til 5 cm, der kan forekomme på injektionsstedet efter vaccinationen.
English: Versican Plus Pi is a vaccine.
Danish: Versican Plus Pi er en vaccine.
English: For revaccination, a single dose of Versican Plus Pi is required annually.
Danish: Der kræves årlig revaccination med en enkelt dosis af Versican Plus Pi.
English: When Versican Plus Pi is given to dogs, the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når Versican Plus Pi gives til hunde, registrerer dyrenes immunsystem virus som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: This will help protect them against kennel cough.
Danish: Derved opnås bedre beskyttelse mod kennelhoste.
English: Versican Plus Pi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.
Danish: Versican Plus Pi leveres som et lyofilisat (en frysetørret pellet) med opløsningsvæske (solvens), der benyttes til at fremstille en suspension til indsprøjtning.
English: The virus in Versican Plus Pi is alive but has been attenuated (weakened) so that does not cause disease.
Danish: Virus i Versican Plus Pi er levende, men er blevet svækket, så de ikke er sygdomsfremkaldende.
English: Versican Plus Pi is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2.
Danish: Versican Plus Pi er en veterinær vaccine, der indeholder levende, svækkede hundeparainfluenzavirus type 2.
English: Other information about Versican Plus Pi:
Danish: Andre oplysninger om Versican Plus Pi:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi exceed the risks for the approved indications and recommended that Versican Plus Pi be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Versican Plus Pi overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af en markedsføringstilladelse for Versican Plus Pi. Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: Canine parainfluenza virus vaccine (live attenuated)
Danish: Hundeparainfluenzavirusvaccine (levende, svækket)
English: The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against kennel cough in addition to other diseases, to demonstrate effectiveness of Versican Plus Pi.
Danish: For at påvise effektiviteten af Versican Plus Pi omfattede feltundersøgelsen de bredere vaccinekombinationer Versican Plus DHPPi/L4 og Versican Plus DHPPi/L4R, som foruden andre sygdomme også er beregnet til at beskytte mod kennelhoste.
English: Versican Plus Pi is used to protect dogs against canine parainfluenza virus, which causes kennel cough.
Danish: Versican Plus Pi anvendes til at beskytte hunde mod hundeparainfluenzavirus, der er årsag til kennelhoste.
English: Why has Versican Plus Pi been approved?
Danish: Hvorfor blev Versican Plus Pi godkendt?
English: What is the risk associated with Versican Plus Pi?
Danish: Hvilken risiko er der forbundet med Versican Plus Pi?
English: How has Versican Plus Pi been studied?
Danish: Hvordan blev Versican Plus Pi undersøgt?
English: The field study showed that vaccination with Versican Plus Pi resulted in protective levels of antibodies for parainfluenza virus ranging from 73 to 97%.
Danish: Feltundersøgelsen viste, at mellem 73 og 97 % af hundene opnåede et beskyttende indhold af antistoffer mod parainfluenzavirus efter vaccination med Versican Plus Pi.
English: What is Versican Plus Pi?
Danish: Hvad er Versican Plus Pi?
English: What benefit has Versican Plus Pi shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus Pi?
English: What is Versican Plus Pi used for?
Danish: Hvad anvendes Versican Plus Pi til?
English: How does Versican Plus Pi work?
Danish: Hvordan virker Versican Plus Pi?
English: 180 tablets l t o r
Danish: 180 filmovertrukne tabletter t r
English: EU/1/14/953/001 Tasermity
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Paknings-størrelse EU/1/14/953/001 Tasermity
English: 800 mg Film-coated tablet Oral use bottle (HDPE)
Danish: 800 mg Filmovertrukket tablet
English: Immediate Packaging
Danish: Til oral anvendelse HDPEtabletbeholder
English: --1 Virus titer no less than of 5 x 107 Inf.U
Danish: --1 virustiter på ikke under 5x107 Inf.E
English: 0.5 ml
Danish: Hætteglas 0,5 ml
English: Route of Administration
Danish: Subkutan anvendelse
English: The application was withdrawn after ‘day 181'.
Danish: Ansøgningen blev trukket tilbage efter "dag 181".
English: This means that it is made by a cell that has received a gene (DNA), which makes the cell able to produce
Danish: Det vil sige, at det produceres af en celle, der har fået indsat et gen (dna), som gør cellen i stand til at producere stoffet.
English: What is Kalbitor?
Danish: Hvad er Kalbitor?
English: How is Kalbitor expected to work?
Danish: Hvordan forventes Kalbitor at virke?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kalbitor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation causes the swelling attacks seen in angioedema.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Kalbitor findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Kalbitor is a medicine that contains the active substance ecallantide.
Danish: Kalbitor er et lægemiddel, der indeholder det aktive stof ecallantid.
English: Kalbitor was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 18 December 2002 for the treatment of angioedema.
Danish: Kalbitor blev udpeget som "lægemiddel til sjældne sygdomme" den 18. december 2002 til behandling af angioødem.
English: The company has informed the CHMP that the withdrawal will not have any consequences for patients enrolled in any trials.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser.
English: What was Kalbitor exp hereditary angioedema have attacks of swelling that can occur anywhere in face, limbs, gut and throat, causing discomfort and pain and sometimes in the difficulty in breathing.
Danish: Patienter med hereditært angioødem får anfaldsvise hævelser, der kan optræde overalt på kroppen, således i ansigtet, på arme og ben, i tarmen og i halsen og som medfører ubehag og smerte og ved angreb i halsen undertiden vejrtrækningsbesvær.
English: Kalbitor was expected to be used to treat symptoms of attacks of hereditary angioedema.
Danish: Kalbitor forventedes anvendt til behandling af symptomer på anfald af hereditært angioødem.
English: Afte assessed the company's responses to the last round of questions in an oral explan some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den sidste runde af spørgsmål ved en mundtlig fremlæggelse, var der stadig nogle uafklarede punkter.
English: l, the CHMP was of the opinion that the benefits of Kalbitor did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Kalbitor ikke var tilfredsstillende påvist og ikke er større end risiciene.
English: Based on the review of the data and the company's resp time of the withdrawal, the CHMP had some concerns and was of the provisional o could not have be
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Kalbitor ikke kunne godkendes.
English: The active substance in Kalbitor, ecallantide, blocks an enzyme in the blood called ‘kallikrein'.
Danish: Det aktive stof i Kalbitor, ecallantid, blokerer enzymet kallikrein, der findes i blodet.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Kalbitor eller i programmer for anvendelse af Kalbitor med særlig udleveringstilladelse?
English: What were the reasons given by the company for withdrawing the
Danish: Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
English: he actions of kallikrein, Kalbitor is lantide in Kalbitor is produced by a method known as ‘recombinant DNA technology'.
Danish: Ecallantid i Kalbitor fremstilles ved "rekombinant dna-teknologi".
English: This means that documentation provided by the company and formulated lists of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
English: 011, Dyax s.a. officially notified the Committee for Medicinal Products for Human ation for Kalbitor, treatment of symptoms of acute attacks of hereditary angioedema.
Danish: Den 11. november 2011 meddelte Dyax s.a. officielt Udvalget for Lægemidler til Mennesker (CHMP), at at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Kalbitor til behandling af symptomer på akutte anfald af hereditært angioødem.
English: Other measures included the time that it took for the attack to resolve.
Danish: Desuden blev bedømmelsen baseret på den tid, anfaldene var om at gå i sig selv.
English: The letter from the company notifying the Agency of the withdrawal of the application is available.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækningen af ansøgningen, kan ses under fanen "All documents".
English: The CHMP had concerns about hypersensitivity reactions, which were see treated with a medicine, and include reactions commonly known as allergic reactions.
Danish: CHMP havde betænkeligheder vedrørende hypersensitivitetsreaktioner, der optrådte med større hyppighed hos patienter behandlet med Kalbitor.
English: By blocking t expected to help reduce the swelling and related symptoms of angioedema.
Danish: Ved at blokere virkningen af kallikrein forventes Kalbitor at mindske hævelsen og de tilknyttede symptomer på angioødem.
English: available as a solution for injection.
Danish: Det var meningen, at det skulle kunne fås som injektionsvæske, opløsning.
English: Hypersensitivity reactions occur when the body's immune system reacts against MP also had concerns related to the effectiveness of the proposed doses in heavier patients.
Danish: Hypersensitivitetsreaktioner optræder, når kroppens immunsystem reagerer mod et lægemiddel.
English: Kallikrein is part of a complex network of proteins (known as the kallikrein-kinin system) that has several effects in the body, one of which results in increased levels of a protein called bradykinin that causes the blood vessels to widen and leak fluid into the surrounding tissue.
Danish: Kallikrein er en del af et kompliceret netværk af proteiner (kallikrein-kinin systemet), der har en række virkninger i kroppen.
English: The effects of Kalbitor were first tested in experimental models before being studie The company presented the results of two main studies in patients aged 1 hereditary angioedema.
Danish: Virksomheden fremlagde resultaterne af to hovedundersøgelser hos patienter fra 10 år og derover med hereditært angioødem.
English: Withdrawal of the marketing authorisation application for
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Kalbitor (ecallantid)
English: There were 72 patients in one study and 96 in the other treated with either Kalbitor or placebo (a dummy treatment) w judged to be at risk of blockage of the airway were given additional treatments i The main measure of effectiveness was based on the improvement in pati hours.
Danish: Patienterne blev enten behandlet med Kalbitor eller placebo (virkningsløs behandling) inden for 8 timer efter at have fået et anfald.
English: ected to be used for?
Danish: Hvad forventedes Kalbitor anvendt til?
English: ents' symptoms after four he evaluation was the application when it was withdrawn?
Danish: Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
English: Pack size
Danish: Voksne
English: Immediate Packaging
Danish: Væskeretention
English: Content (concentration)
Danish: Absorption
English: 28 vials + 28 prefilled syringes
Danish: 28 hætteglas med 1,25 mg teduglutid som pulver 28 fyldte injektionssprøjter med solvens
English: Strength Pharmaceutical Form Route of Administration
Danish: Almene symptomer og reaktioner på administrationsstedet
English: MA (EU) number (Invented) name
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/787/001
English: 28 vials + 28 prefilled syringes; 6 plungers
Danish: Indhold i pakningen: - 1 eller 28 hætteglas med 5 mg teduglutid som pulver - 1 eller 28 fyldte injektionssprøjter med solvens
English: 1 vial + 1 prefilled syringe
Danish: 4.1 Terapeutiske indikationer
English: Annex IV Conditions of the Marketing Authorisation
Danish: Bilag IV Betingelser for markedsføringstilladelsen
English: • Circulation, within 25 days of the Commission Decision, of the adopted Dear Healthcare Professional Communication as specified in the communication plan
Danish: • udsendelse senest 25 dage efter Kommissionens afgørelse af den vedtagne direkte meddelelse til fagfolk i sundhedssektoren i henhold til kommunikationsplanen
English: National Competent Authorities shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne:
English: one type I glass bottle of lyophilisate and one type I glass bottle of solvent, 1 syringe and 1 needle
Danish: En glasflaske type I med lyofilisat og en glasflaske type I med solvens, en sprøjte og en kanyle
English: These studies are still ongoing.
Danish: Undersøgelserne er stadig i gang.
English: This second dose must be given to patients over 60 years of age.
Danish: Denne yderligere dosis skal også gives til patienter over 60 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humenza to Sanofi Pasteur SA on 08 June 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Humenza til Sanofi Pasteur SA den 8. juni 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Humenza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Humenza.
English: Other information about Humenza:
Danish: Andre oplysninger om Humenza:
English: It should only be used for the influenza A (H1N1) flu pandemic that was officially declared by the World Health Organization on 11 June 2009.
Danish: Den må kun anvendes til influenzapandemien influenza A (H1N1), som blev officielt erklæret af Verdenssundhedsorganisationen den 11. juni 2009.
English: Humenza is given according to official recommendations.
Danish: Humenza gives i overensstemmelse med de officielle anbefalinger.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Danish: En influenzapandemi forekommer, når der opstår en ny stamme af influenzavirus, som let smitter fra person til person, fordi mennesker ikke er immune (beskyttede) over for den. En pandemi kan berøre de fleste lande og regioner i verden.
English: A second dose may be given after an interval of at least three weeks, particularly in children from six months to three years of age.
Danish: Efter et interval på mindst tre uger kan der gives en yderligere dosis, særligt til børn i alderen seks måneder til tre år.
English: This means that there is more evidence to come about the medicine, in particular the results of further clinical studies in children, adolescents and adults.
Danish: Det betyder, at der forventes yderligere dokumentation om lægemidlet, navnlig resultaterne af yderligere kliniske undersøgelser af børn, unge og voksne.
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 Humenza.
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 anvendelsesbetingelserne for Humenza.
English: The seroprotection rates in elderly subjects were lower but a second dose was shown to bring about a further response.
Danish: Serobeskyttelsesprocenten hos ældre forsøgspersoner var lavere, men en yderligere dosis viste sig at frembringe yderligere respons.
English: Preliminary results from the three ongoing studies show that one dose of Humenza was able to trigger immunity to a satisfactory level in adults and children.
Danish: Foreløbige resultater fra de tre igangværende undersøgelser viser, at én dosis Humenza er i stand til at skabe en tilfredsstillende grad af immunitet hos voksne og børn.
English: The full EPAR for Humenza can be found here.
Danish: Den fuldstændige EPAR for Humenza findes her.
English: Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Danish: Humenza pandemisk influenzavaccine (H1N1) (split virion, inaktiveret, adjuveret)
English: Three studies are being carried out with Humenza containing the H1N1 strain, one in 300 adults and 150 elderly patients (over 60 years of age), and two in a total of 700 children aged between six months and 17 years of age.
Danish: Der udføres tre undersøgelser med Humenza indeholdende H1N1-stammen: en undersøgelse af 300 voksne og 150 ældre patienter (over 60 år) og to undersøgelser af i alt 700 børn i alderen seks måneder til 17 år.
English: The company that makes Humenza will collect information on the safety of the vaccine while it is being used.
Danish: Virksomheden, der fremstiller Humenza, skal indsamle oplysninger om vaccinens sikkerhed, mens den anvendes.