FrancophonIA/ELRC3.0 huggingface dataset:
English: Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride.
Danish: Fortekor Plus indeholder to aktive stoffer, pimobendan og benazeprilhydrochlorid.
English: The main measure of effectiveness was the total score of exercise intolerance, demeanour, breathing effort, coughing and difficulty of breathing at night.
Danish: Det vigtigste mål for virkningen var den samlede score for motionsintolerans, adfærd, vejrtrækningsanstrengelse, hoste og vejrtrækningsbesvær om natten.
English: For more information about treatment with Fortekor Plus, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fortekor Plus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din dyrlæge eller dit apotek.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Danish: Benazepril er et forstadium (prodrug), der omdannes til benazeprilat i kroppen.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Fortekor Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners/keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Fortekor Plus, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy.
Danish: Gravide kvinder skal være ekstra forsigtige med at undgå utilsigtet indtagelse af Fortekor Plus, da indtagelse af ACE-hæmmere under graviditet skader det ufødte barn.
English: For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Fortekor Plus fremgår af indlægssedlen.
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Danish: Benazeprilat er en ACE-hæmmer (en hæmmer af "angiotensin converting enzyme" (ACE)).
English: Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery).
Danish: Fortekor Plus må ikke gives til hunde med nedsat blodafgivelse fra hjertet som følge af fortykkede hjertekammervægge (hypertrof kardiomyopati) eller med nedsat blodafgivelse fra hjertet af funktionelle eller anatomiske årsager (f.eks. forsnævring af hovedpulsåren eller lungepulsåren).
English: It is only for use in dogs whose heart failure is already being controlled by the same doses of pimobendan and benazepril hydrochloride given as separate medicines.
Danish: Det er udelukkende beregnet til hunde, hvis hjertesvigt i forvejen kontrolleres med samme doser af pimobendan og benazeprilhydrochlorid givet hver for sig.
English: What benefits of Fortekor Plus have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Fortekor Plus?
English: The study showed Fortekor Plus to be as effective as pimobendan and benazepril when given as separate treatments.
Danish: Undersøgelsen viste, at Fortekor Plus var lige så effektivt som pimobendan og benazepril givet hver for sig.
English: How is Fortekor Plus used?
Danish: Hvordan anvendes Fortekor Plus?
English: In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments.
Danish: Der er udført en feltundersøgelse med 67 hunde med hjertesvigt med væskeophobning, hvor Fortekor Plus blev sammenlignet med pimobendan og benazepril indgivet hver for sig.
English: How does Fortekor Plus work?
Danish: Hvordan virker Fortekor Plus?
English: For practical information about using Fortekor Plus, animal owners/keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Fortekor Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: Angiotensin II er et stof med stor evne til at få blodkarrene til at trække sig sammen (et karkontraherende stof eller en vasokonstriktor).
English: Target Species
Danish: Dyrearter, som lægemidlet er beregnet til:
English: This is expected to help to protect against the disease caused by the virus.
Danish: Dette forventes at medvirke til at beskytte mod den sygdom, som virussen forårsager.
English: Emerflu is a vaccine.
Danish: Emerflu er en vaccine.
English: The effects of Emerflu were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Emerflu blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The higher dose vaccine also contained the adjuvant.
Danish: Den højere dosis vaccine indeholdt desuden adjuvansen.
English: Emerflu contains a flu strain called ‘A/Vietnam/1194/2004 NIBRG 14' (H5N1).
Danish: Emerflu indeholder influenzastammen "A/VietNam/1194/2004 NIBRG-14" (H5N1).
English: The main measure of effectiveness was the level of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Danish: Behandlingens virkning blev hovedsagelig bedømt på mængden af antistoffer mod influenzavirussen i blodet på tre forskellige tidspunkter: inden vaccination, den dag, hvor den anden vaccination blev givet (dag 21), og 21 dage senere (dag 42).
English: A flu pandemic happens when a new type (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 bryder ud, når der opstår en ny type (stamme) af en influenzavirus, der let spredes fra person til person, fordi mennesker ikke har nogen immunitet (beskyttelse) over for den. En pandemi kan berøre de fleste lande og regioner i verden.
English: Withdrawal of the marketing authorisation application for Emerflu [pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)]
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Emerflu [pandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)]
English: Therefore, the Committee was also concerned that the vaccine's immunogenicity was low, regardless of the strain of virus included, and that the vaccine might not be able to adequately prepare the immune system for future infections.
Danish: Derfor var udvalget også bekymret for, at vaccinens immunogenicitet var lav, uanset hvilken virusstamme den var baseret på, og at vaccinen måske ikke i tilstrækkelig grad kunne forberede immunsystemet på fremtidige infektioner.
English: It is a suspension for injection that contains parts of influenza (flu) viruses that have been inactivated (killed).
Danish: Det er en suspension til injektion, der indeholder dele af influenzavira, som er blevet inaktiveret (dræbt).
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Danish: Ifølge de kriterier, der er fastlagt af CHMP, skal en modelvaccine frembringe en beskyttende mængde antistoffer hos mindst 70 % af de vaccinerede personer, for at den anses for egnet.
English: What is Emerflu?
Danish: Hvad er Emerflu?
English: Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.
Danish: Da antistofproduktionen efter administration af Emerflu lå under dette niveau i hovedundersøgelserne (under 40 % hos deltagerne under 60 år), var det CHMP's bekymring, at Emerflu ikke var egnet til brug som modelvaccine.
English: On 1 December 2010, Sanofi Pasteur SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Emerflu, for the prevention of ‘pandemic' flu.
Danish: Den 1. december 2010 meddelte Sanofi Pasteur SA officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Emerflu til forebyggelse af "pandemisk" influenza.
English: Emerflu contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Danish: Emerflu indeholder små mængder af hæmagglutininer (overfladeproteiner) fra en virus, der kaldes H5N1.
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Danish: Man kan i stedet fremstille en vaccine, der indeholder en influenzastamme, som er specifikt udvalgt, fordi ingen har været udsat for den, og ingen er immun over for den.
English: Emerflu was expected to be used in adults to protect against ‘pandemic' flu.
Danish: Emerflu forventedes anvendt til voksne for at beskytte mod "pandemisk" influenza.
English: What was Emerflu expected to be used for?
Danish: Hvad forventedes Emerflu anvendt til?
English: It was only intended for use once a flu pandemic had been officially declared.
Danish: Den var kun beregnet til brug, når der officielt var erklæret influenzapandemi.
English: The company informed the CHMP that, at the time of the withdrawal, there were no clinical trials being carried out with Emerflu.
Danish: Virksomheden har informeret CHMP om, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med Emerflu.
English: If a pandemic were to start, the virus strain in Emerflu would have been replaced by the strain causing the pandemic before the vaccine could have been used.
Danish: Hvis en pandemi bryder ud, ville virusstammen i Emerflu blive erstattet af den stamme, der forårsager pandemien, før vaccinen kunne anvendes.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium), which is expected to stimulate a better response.
Danish: Vaccinen indeholder desuden en "adjuvans" (et aluminiumholdigt stof), der forventes at forstærke immunresponsen.
English: At that point in time, the CHMP was of the opinion that the benefits of Emerflu used for prophylaxis of influenza in an officially declared pandemic situation did not outweigh its risks.
Danish: CHMP var på daværende tidspunkt af den opfattelse, at fordelene ved Emerflu til forebyggelse af influenza i en officielt erklæret pandemi ikke opvejede risiciene.
English: This is a special type of vaccine that is designed to help with the management of a pandemic.
Danish: Det er en særlig vaccinetype, der er beregnet til at holde en pandemi under kontrol.
English: Similar results were seen in the people who received Emerflu that contained a different strain of flu virus, and there were contradictory results in the studies looking at the effects of a third dose of Emerflu.
Danish: Der sås tilsvarende resultater hos personer, som fik Emerflu med en anden stamme af influenzavirus, og der var modstridende resultater i undersøgelser, som så på virkningen af en tredje dosis Emerflu.
English: Hence, the CHMP recommended that Emerflu be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Emerflu.
English: The main study of Emerflu included 600 healthy adults and compared the ability of two doses of Emerflu, to trigger the production of antibodies (‘immunogenicity').
Danish: Hovedundersøgelsen af Emerflu omfattede 600 raske voksne og sammenlignede Emerflus egenskaber i forskellige doser med hensyn til at danne antistoffer ("immunogenicitet").
English: The CHMP was concerned over the ability of Emerflu to trigger the production of enough antibodies against the flu virus.
Danish: CHMP var bekymret for, om Emerflu kunne danne tilstrækkeligt med antistoffer mod influenzavirus.
English: How was Emerflu expected to work?
Danish: Hvordan forventedes Emerflu at virke?
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 Emerflu eller i programmer for anvendelse af Emerflu med særlig udleveringstilladelse?
English: Some of the participants in the studies of Emerflu went on to receive a third dose of the vaccine, containing either of the two flu virus strains, with or without the adjuvant.
Danish: Nogle af deltagerne i undersøgelserne af Emerflu fik desuden en tredje dosis af vaccinen, som indeholdt en af de to influenzavirusstammer med eller uden adjuvans.
English: In addition, 100 further people received Emerflu that contained a different strain of flu virus.
Danish: Desuden fik yderligere 100 personer Emerflu, som indeholdt en anden stamme influenzavirus.
English: The participants received two injections of Emerflu containing one of two different doses of haemagglutinin.
Danish: Deltagerne modtog to indsprøjtninger med Emerflu, som indeholdt to forskellige doser af hæmagglutinin.
English: Emerflu was expected to work as a ‘mock-up' vaccine.
Danish: Emerflu forventedes at virke som en modelvaccine.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når man bliver vaccineret, opfatter immunsystemet virussen som "fremmed" og danner antistoffer mod den. Immunsystemet kan således danne antistoffer hurtigere, når det eksponeres for samme virus igen.
English: They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Danish: Derved kan det forudsiges, hvordan mennesker vil reagere på en vaccine med den influenzastamme, der er årsag til en pandemi.
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Danish: Først når pandemien bryder ud, ved man, hvilken influenzavirusstamme der forårsager den.
English: 2 x 5 pre-filled syringes without safety device
Danish: 1 pre-filled syringe uden sikkerhedsanordning
English: Severe neutropenia lasted just over one-and-a-half days on average with both medicines.
Danish: Svær neutropeni varede lidt over halvanden dag i gennemsnit med begge lægemidler.
English: Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek.
Danish: Yderligere information om Grasustek findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/grasustek.
English: Other information about Grasustek
Danish: Andre oplysninger om Grasustek
English: What measures are being taken to ensure the safe and effective use of Grasustek?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Grasustek?
English: This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Danish: Det betyder, at Grasustek i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
English: The reference medicine for Grasustek is Neulasta.
Danish: Referencelægemidlet for Grasustek er Neulasta.
English: Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment.
Danish: Grasustek gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver kræftbehandlingforløb.
English: An overview of Grasustek and why it is authorised in the EU
Danish: En oversigt over Grasustek, og hvorfor det er godkendt i EU
English: The most common side effect with Grasustek (which may affect more than 1 in 10 people) is pain in the bones.
Danish: Den hyppigste bivirkning ved Grasustek (som optræder hos mere end 1 ud af 10 patienter) er knoglesmerter.
English: As for all medicines, data on the use of Grasustek are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Grasustek løbende overvåget.
English: Grasustek can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Grasustek udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodsygdomme.
English: Side effects reported with Grasustek are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Grasustek vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Why is Grasustek authorised in the EU?
Danish: Hvorfor blev Grasustek godkendt i EU?
English: For more information about using Grasustek, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Grasustek, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What is Grasustek and what is it used for?
Danish: Hvad er Grasustek, og hvad anvendes det til?
English: What are the risks associated with Grasustek?
Danish: Hvilke risici er der forbundet med Grasustek?
English: Because Grasustek is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Grasustek.
Danish: Da Grasustek er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke alle at blive gentaget for Grasustek.
English: The safety of Grasustek has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Danish: Sikkerheden ved Grasustek er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet Neulasta.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Grasustek har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: The active substance in Grasustek, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Grasustek, pegfilgrastim, er en form for filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: Grasustek is a ‘biosimilar medicine'.
Danish: Grasustek er et "biosimilært lægemiddel".
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Grasustek outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Grasustek opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: Grasustek is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Danish: Grasustek er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastiske syndromer (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Det fås som en fyldt sprøjte med injektionsvæske, der indeholder en opløsning til injektion under huden.
English: In addition, a study involving 248 patients who had chemotherapy after surgery for breast cancer showed that Grasustek was as effective as Neulasta in reducing the duration of neutropenia.
Danish: Desuden viste et studie, hvori der indgik 248 patienter, som var i behandling med kemoterapi efter brystkræftoperation, at Grasustek var lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: All these data were considered sufficient to conclude that Grasustek will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Grasustek vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: For the full list of side effects and restrictions with Grasustek, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Grasustek fremgår af indlægssedlen.
English: In Grasustek, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Grasustek er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: Studies have also shown that giving Grasustek produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at Grasustek giver samme niveau af det aktive stof i kroppen som Neulasta.
English: Laboratory studies comparing Grasustek with Neulasta have shown that the active substance in Grasustek is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Grasustek med Neulasta, har vist, at det aktive stof i Grasustek svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: What benefits of Grasustek have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Grasustek?
English: How is Grasustek used?
Danish: Hvordan anvendes Grasustek?
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Grasustek in reducing the duration of neutropenia is equivalent to that of Neulasta.
Danish: Studier, der omfatter brystkræftpatienter, der er i behandling med kemoterapi, har desuden vist, at Grasustek er lige så effektivt som Neulasta til at nedsætte varigheden af neutropeni.
English: How does Grasustek work?
Danish: Hvordan virker Grasustek?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grasustek have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Grasustek.
English: Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
Danish: Grasustek er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: This summary was last updated in 06-2006.
Danish: Dette sammendrag blev sidst ajourført i 06-2006.
English: Medicinal product no longer authorise©EMEA 2006
Danish: Lægemidlet er ikke længere autoriseret til sal©EMEA 2006