FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by separation from their owners or homes or from other dogs (separation anxiety).
Danish: Reconcile er et lægemiddel til dyr, der anvendes som hjælp til at behandle hunde med adfærdsproblemer, som skyldes adskillelse fra deres ejere eller hjem eller fra andre hunde (separationsangst).
English: Other information about Reconcile?
Danish: Andre oplysninger om Reconcile
English: For the full list of all side effects and restrictions reported with Reconcile, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Reconcile fremgår af indlægssedlen.
English: What benefits of Reconcile have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Reconcile?
English: How is Reconcile used?
Danish: Hvordan anvendes Reconcile?
English: How does Reconcile work?
Danish: Hvordan virker Reconcile?
English: For more information about treatment with Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer af eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Reconcile, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Reconcile, animal owners or 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 Reconcile, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Outcome of re-examination
Danish: Resultat af revurderingen
English: In addition, major changes were made to the study design while the study was ongoing, which made the results difficult to interpret.
Danish: Desuden blev der foretaget større ændringer i udformningen af undersøgelsen, mens undersøgelsen stadig var i gang, og det gjorde det vanskeligt at fortolke resultaterne.
English: those involved in stimulating the cells to grow and divide.
Danish: dem, der stimulerer cellernes vækst og deling.
English: The main measure of effectiveness was based on improvements in any of these four symptoms during the first 24 weeks of treatment.
Danish: Virkningen blev hovedsagelig målt på bedringen med hensyn til et eller flere af disse fire symptomer i løbet af de første 24 ugers behandling.
English: The company that applied for authorisation is AB Science.
Danish: Virksomheden, der har indgivet ansøgningen, er AB Science.
English: What was Masipro expected to be used for?
Danish: Hvad forventedes Masipro anvendt til?
English: What is Masipro?
Danish: Hvad er Masipro?
English: The company requested a re-examination of the initial opinion.
Danish: Virksomheden har anmodet om en revurdering af udtalelsen.
English: The CHMP refusal was confirmed after re-examination.
Danish: CHMP's afslag blev bekræftet ved revurderingen.
English: Refusal of the marketing authorisation for Masipro (masitinib)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masipro (masitinib)
English: The CHMP was concerned about the reliability of the study results because a routine GCP (good clinical practice) inspection at the study sites revealed serious failings in the way the study had been conducted.
Danish: CHMP var betænkelig ved undersøgelsesresultaternes pålidelighed, fordi man ved en rutinemæssig inspektion for god klinisk praksis (GCP) på undersøgelsescentrene fandt alvorlige mangler i forhold til den måde, undersøgelsen var blevet gennemført på.
English: Refusal of the marketing authorisation for Masipro (masitinib) EMA/599464/2017
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masipro (masitinib) EMA/599464/2017
English: By blocking these enzymes, Masipro is thought to help slow down the growth of the mast cells.
Danish: Ved at blokere disse enzymer menes Masipro at medvirke til at bremse mastcellernes vækst.
English: The applicant presented data from a main study involving 135 patients with systemic mastocytosis who had severe symptoms including at least one of the following four: itching, hot flushes, depression and tiredness.
Danish: Ansøgeren fremlagde data fra en hovedundersøgelse af 135 patienter med systemisk mastocytose, der havde svære symptomer, herunder mindst ét af følgende fire: kløe, hedeture, depression og træthed.
English: Therefore, the CHMP was of the opinion that the benefits of Masipro did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP var derfor af den opfattelse, at fordelene ved Masipro ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: This means that it blocks enzymes known as tyrosine kinases, which can be found in some receptors in mast cells including
Danish: Det betyder, at det blokerer for de enzymer, der kaldes tyrosinkinaser, og som findes i nogle af mastcellernes receptorer, herunder
English: In the study, Masipro was compared with placebo (a dummy treatment).
Danish: Undersøgelsen sammenlignede Masipro med placebo (en uvirksom behandling).
English: Masipro is a medicine that contains the active substance masitinib.
Danish: Masipro er et lægemiddel, der indeholder det aktive stof masitinib.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masipro, intended for the treatment of systemic mastocytosis.
Danish: Den 18. maj 2017 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Masipro, der er beregnet til behandling af systemisk mastocytose.
English: Masipro was expected to be used to treat adults with systemic mastocytosis, a disease in which there are too many mast cells (a type of white blood cell) in the skin, bones and various body organs, causing symptoms such as itchy skin, hot flushes, palpitations, fainting, bone pain, tiredness, vomiting, diarrhoea and depression.
Danish: Masipro skulle anvendes til behandling af voksne patienter med systemisk mastocytose, en sygdom, hvor der er for mange mastceller (en type hvide blodlegemer) i hud, knogler og forskellige organer, og som giver symptomer som hudkløe, hedeture, hjertebanken, besvimelse, knoglesmerter, træthed, opkastning, diarré og depression.
English: How does Masipro work?
Danish: Hvordan virker Masipro?
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Danish: CHMP gennemgik begrundelsen for anmodningen og revurderede udtalelsen, og bekræftede den 14. september 2017 afslaget på ansøgningen om markedsføringstilladelse.
English: Masipro was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for mastocytosis.
Danish: Masipro blev den 16. november 2004 udpeget som "lægemiddel til sjældne sygdomme" til behandling af mastocytose.
English: The active substance in Masipro, masitinib, is a tyrosine kinase inhibitor.
Danish: Det aktive stof i Masipro, masitinib, er en såkaldt tyrosinkinasehæmmer.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse.
English: Finally, data on the safety of the medicine were limited and there were concerns regarding the medicine's side effects, including neutropenia (low levels of white blood cells) and harmful effects on the skin and liver, which were of relevance particularly because the medicine was to be used long term.
Danish: Bivirkningerne vakte bekymring, herunder neutropeni (lavt antal hvide blodlegemer) og skadevirkninger på hud og lever.
English: Invented name Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage
English: Horse Intramuscular use Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap.
Danish: Intramuskulær Hætteglas (Type I glas) lukket med en halogenobutyl gummiprop og aluminiums-hætte.
English: A/equine-2/South Africa/4/03 strain 50 AU/ml A/equine-2/Newmarket/2/93 strain
Danish: A/equine-2/Newmarket/2/93 stamme
English: 1 dose 1 pre-filled syringe
Danish: 1 dosis 1 præfyldt sprøjte
English: 1 dose 10 glass vials
Danish: 1 dosis 10 hætteglas Nul døgn
English: Strength Pharmaceutical form
Danish: Særnavn Styrke
English: --1 Equine influenza virus strains:
Danish: --1 Equin influenzavirus stammer: A/equine-2/Sydafrika/4/03 stamme
English: MA (EU) number Invented name
Danish: EU-nummer
English: They involved over 5,000 people from 4 years of age.
Danish: De omfattede over 5 000 personer fra 4 år og derover.
English: This will help to protect against the disease caused by the virus.
Danish: Dette medvirker til at beskytte mod den sygdom, som virusset forårsager.
English: The vaccine can only be obtained with a prescription and should be used according to official recommendations.
Danish: Vaccinen udleveres kun efter recept og bør anvendes i henhold til de officielle anbefalinger.
English: The immune system will then be able to respond more quickly when it is exposed to the virus again.
Danish: Derefter vil immunsystemet kunne reagere hurtigere, næste gang det udsættes for det samme virus.
English: The recommended dose is one single injection into a muscle (0.5 ml), preferably in the upper arm.
Danish: Den anbefalede dosis er en enkelt injektion i en muskel (0,5 ml), fortrinsvis i overarmen.
English: The composition of Flucelvax Tetra will be updated annually according to WHO and EU recommendations.
Danish: Sammensætningen af Flucelvax Tetra vil blive ajourført hvert år i overensstemmelse med WHO's og EU's henstillinger.
English: Further information on Flucelvax Tetra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
Danish: Yderligere information om Flucelvax Tetra findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season in the northern hemisphere.
Danish: Verdenssundhedsorganisationen (WHO) udsender hvert år anbefalinger for, hvilke influenzastammer der bør være indeholdt i vacciner til den efterfølgende influenzasæson på den nordlige halvkugle.
English: The most common side effects with Flucelvax Tetra (which may affect more than 1 in 10 people) are pain at the injection site, reddening of the skin and hardening at the injection site, headache, tiredness and muscle pain.
Danish: De hyppigste bivirkninger ved Flucelvax Tetra (som kan forekomme hos mere end 1 ud af 10 personer) er smerter på injektionsstedet, rødme af huden og hærdning på injektionsstedet, hovedpine, træthed og muskelsmerter.
English: For more information about using Flucelvax Tetra, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Flucelvax Tetra, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The studies assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies.
Danish: I studierne blev vaccinernes evne til at fremkalde en immunreaktion mod influenza vurderet ved måling af dannelsen af beskyttende antistoffer.
English: Side effects reported with Flucelvax Tetra are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Flucelvax Tetra vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: As for all medicines, data on the use of Flucelvax Tetra are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Flucelvax Tetra løbende overvåget.
English: When a person is given the vaccine, the immune system recognises the virus proteins as ‘foreign' and makes defences against them.
Danish: Når en person vaccineres, opfatter immunsystemet virusproteinerne som "fremmede" og danner antistoffer mod dem.
English: The European Medicines Agency therefore decided that Flucelvax Tetra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Flucelvax Tetra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulate as different strains and subtypes, which change over time.
Danish: Influenza skyldes hovedsagelig to typer influenzavirus, influenza A og B. Hvert af dem optræder som forskellige stammer eller undertyper, der ændrer sig med tiden.
English: Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza AH3N2 virus, and one influenza B virus.
Danish: Historisk har vacciner mod sæsonbetinget influenza indeholdt tre influenzastammer, nemlig ét influenza A-H1N1-virus, ét influenza A-H3N2-virus og ét influenza B-virus.
English: Flucelvax Tetra contains proteins from four different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains), chosen based on the official recommendation for the annual flu season.
Danish: Flucelvax Tetra indeholder proteiner fra fire forskellige inaktiverede stammer af influenza A- og B-virus (type A-H1N1, type A-H3N2 og to type B-stammer), som er valgt på grundlag af den officielle anbefaling for den årlige influenzasæson.
English: The inclusion of two influenza B strains in Flucelvax Tetra can provide a broader protection against influenza B. In terms of safety, side effects with Flucelvax Tetra are similar to those observed with vaccines containing three influenza strains and are mostly mild to moderate in severity.
Danish: Tilføjelsen af to influenza B-stammer ved Flucelvax Tetra kan give en bredere beskyttelse mod influenza B. For så vidt angår sikkerhed, er bivirkningerne ved Flucelvax Tetra svarende til dem, der er iagttaget med vacciner, der indeholder tre influenzastammer, og de er for det meste milde til moderate.
English: One of the vaccines was Optaflu, a previously authorised vaccine which contains three of the four strains of influenza in Flucelvax Tetra and whose effectiveness in preventing flu is well established.
Danish: En af vaccinerne var Optaflu, en tidligere godkendt vaccine, som indeholder tre af de fire influenzastammer i Flucelvax Tetra, og hvis effektivitet med hensyn til forebyggelse af influenza er almindelig anerkendt.
English: Flucelvax Tetra was compared with two comparator vaccines in 2 main studies.
Danish: Flucelvax Tetra blev sammenlignet med to sammenligningsvacciner i 2 hovedstudier.
English: What measures are being taken to ensure the safe and effective use of Flucelvax Tetra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Flucelvax Tetra?
English: The other vaccine is based on Optaflu but contains the other B strain of Flucelvax Tetra.
Danish: Den anden vaccine er baseret på Optaflu, men indeholder den anden B-stamme af Flucelvax Tetra.
English: An overview of Flucelvax Tetra and why it is authorised in the EU
Danish: En oversigt over Flucelvax Tetra, og hvorfor den er godkendt i EU
English: Flucelvax Tetra is a vaccine used to protect adults and children from 9 years of age against influenza (flu).
Danish: Flucelvax Tetra er en vaccine, der anvendes til beskyttelse af voksne og børn fra 9 år og derover mod influenza.
English: Other information about Flucelvax Tetra
Danish: Andre oplysninger om Flucelvax Tetra
English: Flucelvax Tetra is a vaccine.
Danish: Flucelvax Tetra er en vaccine.
English: Flucelvax Tetra is as effective as the comparator vaccines at stimulating immune responses against the 4 strains included in the vaccine in people from 9 years of age.
Danish: Flucelvax Tetra er lige så effektivt som sammenligningsvaccinerne til at stimulere immunrespons mod de 4 stammer, der indgår i vaccinen hos personer, der er fyldt 9 år.
English: Flucelvax Tetra contains proteins from the surface of four different strains of flu virus.
Danish: Flucelvax Tetra indeholder proteiner fra overfladen af fire forskellige influenzavirusstammer.
English: The viruses used to produce Flucelvax Tetra are grown in mammalian cells.
Danish: De vira, der anvendes til fremstilling af Flucelvax Tetra, er dyrket i pattedyrceller.
English: Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.
Danish: Sammenligningsvaccinerne indeholder tilsammen de fire influenzastammer i Flucelvax Tetra.
English: Why is Flucelvax Tetra authorised in the EU?
Danish: Hvorfor er Flucelvax Tetra godkendt i EU?
English: Results showed that Flucelvax Tetra lead to similar levels of protective antibodies as the comparator vaccines in people from 9 years of age.
Danish: Resultaterne viste, at Flucelvax Tetra førte til samme mængde beskyttende antistoffer som sammenligningsvaccinerne hos personer fra 9 år og derover.
English: For the full list of side effects and restrictions with Flucelvax Tetra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Flucelvax Tetra fremgår af indlægssedlen.
English: What is Flucelvax Tetra and what is it used for?
Danish: Hvad er Flucelvax Tetra, og hvad anvendes den til?
English: Flucelvax Tetra includes an additional B virus strain.
Danish: Flucelvax Tetra indeholder en yderligere B-virusstamme.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Flucelvax Tetra 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 Flucelvax Tetra.
English: Flucelvax Tetra is available as a suspension for injection in a pre-filled syringe.
Danish: Flucelvax Tetra fås som injektionsvæske (suspension) i en fyldt sprøjte.
English: What are the risks associated with Flucelvax Tetra?
Danish: Hvilke risici er der forbundet med Flucelvax Tetra?
English: How does Flucelvax Tetra work?
Danish: Hvordan virker Flucelvax Tetra?
English: How is Flucelvax Tetra used?
Danish: Hvordan anvendes Flucelvax Tetra?
English: What benefits of Flucelvax Tetra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Flucelvax Tetra?
English: The full EPAR for Liprolog can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Liprolog findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Liprolog.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Liprolog.
English: Liprolog Mix is a mixture of these two formulations.
Danish: Liprolog Mix er en blanding af disse to former.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Liprolog on 1 August 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Liprolog den 1. august 2001.
English: A risk management plan has been developed to ensure that Liprolog is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Liprolog anvendes så sikkert som muligt.
English: Patients can inject themselves with this medicine if they have been trained appropriately.
Danish: Patienterne kan godt selv give injektionerne, hvis de er blevet behørigt instrueret heri.
English: Liprolog is a range of solutions and suspensions for injection.
Danish: Liprolog er en serie opløsninger og suspensioner til injektion.
English: What measures are being taken to ensure the safe and effective use of Liprolog?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Liprolog?
English: Other information about Liprolog
Danish: Andre oplysninger om Liprolog
English: Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Danish: Liprolog og Liprolog Mix gives normalt umiddelbart inden et måltid, men kan gives umiddelbart efter et måltid, hvis det er nødvendigt.
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 Liprolog.
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 Liprolog skal anvendes.
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Når blodsukkeret reguleres, mindskes diabetessymptomerne og -komplikationerne.
English: For more information about treatment with Liprolog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Liprolog, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is the risk associated with Liprolog?
Danish: Hvilken risiko er der forbundet med Liprolog?
English: Studies also looked at the use of Liprolog in 542 patients aged between two and 19 years, and the use of Liprolog in combination with sulphonylureas.
Danish: I undersøgelserne så man også nærmere på anvendelsen af Liprolog hos 542 patienter mellem to og 19 år og på anvendelsen af Liprolog i kombination med sulfonylurinstoffer.
English: Liprolog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Danish: Liprolog blev oprindelig undersøgt i otte kliniske undersøgelser, der omfattede 2 951 patienter med type 1-diabetes (hvor kroppen ikke kan producere insulin) eller type 2-diabetes (hvor kroppen ikke kan udnytte insulinet effektivt).
English: The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Danish: Forskellen betyder, at insulin lispro optages hurtigere i kroppen end almindeligt humant insulin og derfor virker hurtigere.
English: Insulin lispro is very slightly different from human insulin.
Danish: Insulin lispro adskiller sig en smule fra humant insulin.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at regulere glukosemængden i blodet, eller hvor kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Liprolog, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Liprolog, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: LiprologLiprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Danish: Det kan være nødvendigt at justere dosis af Liprolog, når det gives sammen med andre lægemidler, der kan indvirke på blodglukoseniveauet.