FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for NovoThirteen.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for NovoThirteen.
English: The full EPAR for NovoThirteen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for NovoThirteen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The condition must be confirmed by suitable tests before starting treatment.
Danish: Sygdommen skal være bekræftet gennem passende prøver, før behandlingen påbegyndes.
English: A risk management plan has been developed to ensure that NovoThirteen is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at NovoThirteen anvendes så sikkert som muligt.
English: This dose is given in a single, slow injection into a vein.
Danish: Denne dosis gives som en enkelt langsom injektion i en vene.
English: Other information about NovoThirteen
Danish: Andre oplysninger om NovoThirteen
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 NovoThirteen.
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 NovoThirteen skal anvendes.
English: Moreover, no major side effects were seen with long term use of NovoThirteen.
Danish: Desuden blev der ikke iagttaget væsentlige bivirkninger ved langsigtet brug af NovoThirteen.
English: For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med NovoThirteen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of NovoThirteen?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NovoThirteen?
English: The study was extended for a further year in 33 of the patients, to look at the long-term safety of treatment with NovoThirteen.
Danish: Undersøgelsen blev forlænget med et år for 33 af patienterne for at fastlægge den langsigtede sikkerhed af behandlingen med NovoThirteen.
English: NovoThirteen is a medicine that contains the active substance catridecacog.
Danish: NovoThirteen er et lægemiddel, der indeholder det aktive stof catridecacog.
English: During the long-term study, no bleeding episodes were observed in children below 6 years of age treated with NovoThirteen.
Danish: I langtidsundersøgelsen blev der ikke observeret nogen blødningsepisoder hos børn under seks år behandlet med NovoThirteen.
English: The CHMP concluded that the main study provided satisfactory results in terms of effectiveness, since no severe or life-threatening bleedings took place during treatment with NovoThirteen.
Danish: CHMP konkluderede, at hovedundersøgelsens resultater var tilfredsstillende hvad angår lægemidlets virkning, da der ikke forekom svære eller livstruende blødninger under behandlingen med
English: The patients were given NovoThirteen for one year for preventative use.
Danish: Patienterne fik NovoThirteen i ét år som forebyggende behandling.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoThirteen, 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 NovoThirteen, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The safety and effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Danish: NovoThirteens sikkerhed og virkning hos børn under seks år blev understøttet af foreløbige data fra en løbende langtidsundersøgelse, hvor patienterne fik NovoThirteen til forebyggelse af blødningsepisoder.
English: Treatment with NovoThirteen should be started under the supervision of a doctor experienced in treating rare bleeding disorders.
Danish: Behandling med NovoThirteen bør indledes af en læge med erfaring i behandling af sjældne blødningsforstyrrelser.
English: What is the risk associated with NovoThirteen?
Danish: Hvilken risiko er der forbundet med NovoThirteen?
English: The active substance in NovoThirteen, catridecacog, is structurally the same as the human factor XIII A-subunit.
Danish: Det aktive stof i NovoThirteen, catridecacog, har samme opbygning som den naturlige faktor XIII A-subunit.
English: The most common side effects with NovoThirteen (seen in between 1 and 10 patients in 100) are headache, leucopenia (low white blood cell counts), aggravated neutropenia (low levels of neutrophils, a type of white blood cell), pain in the extremities, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer'.
Danish: De hyppigste bivirkninger ved NovoThirteen (som optræder hos mellem 1 og 10 ud af 100 patienter) er hovedpine, leukopeni (lavt antal hvide blodlegemer), forstærket neutropeni (lavt antal hvide blodlegemer af typen neutrofile), smerter i arme og ben samt smerter på injektionsstedet.
English: NovoThirteen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved NovoThirteen opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for NovoThirteen.
English: In certain situations the doctor may decide to adjust the dose required to prevent bleeding, based on the patient's factor XIII levels in the blood.
Danish: I visse situationer kan lægen vælge at tilpasse den blødningsforebyggende dosis ud fra blodets indhold af faktor XIII.
English: Patients with congenital factor XIII A-subunit deficiency do not have enough of the factor XIII A-subunit, or it does not work correctly, which makes them prone to bleeding.
Danish: Patienter med medfødt mangel på faktor XIII A-subunit har enten for lidt faktor XIII A-subunit, eller også virker denne ikke korrekt, hvilket medfører blødninger.
English: Additionally, the company that markets NovoThirteen will provide all doctors who are expected to prescribe it with an information pack for doctors and patients containing important information on the correct use of the medicine.
Danish: Den virksomhed, der markedsfører NovoThirteen, skal desuden udlevere en informationspakke til patienterne og til alle læger, der forventes at udskrive lægemidlet.
English: This is an inherited blood clotting disorder characterised by bleeding episodes.
Danish: Sygdommen er en arvelig forstyrrelse i blodets størkning og er kendetegnet ved blødningsepisoder.
English: This compared with around 2.9 episodes per year per patient treated on demand with another medicine containing factor XIII.
Danish: Til sammenligning forekom der ca. 2,9 episoder pr. år pr. patient, som blev behandlet efter behov med et andet lægemiddel indeholdende faktor XIII.
English: Why has NovoThirteen been approved?
Danish: Hvorfor blev NovoThirteen godkendt?
English: Factor XIII is a protein involved in the blood clotting process.
Danish: Faktor XIII er et protein, der medvirker ved blodets størkning.
English: NovoThirteen was investigated in a main study involving 41 adults and children above 6 years of age with congenital factor XIII A-subunit deficiency who had been treated in the past with medicines containing factor XIII.
Danish: NovoThirteen blev undersøgt i én hovedundersøgelse af 41 voksne og børn over seks år med medfødt mangel på faktor XIII A-subunit.
English: The rate of bleeding episodes in patients receiving NovoThirteen preventatively was lower than the rate seen in the earlier data from patients treated on demand with another medicine containing factor XIII.
Danish: Antallet af blødningsepisoder hos de patienter, der fik NovoThirteen som forebyggende behandling, var lavere end hos de tidligere registrerede patienter, der var behandlet efter behov med et andet lægemiddel indeholdende faktor XIII.
English: What is NovoThirteen?
Danish: Hvad er NovoThirteen?
English: This includes information on storage procedures, since incorrect storage after reconstitution can cause increased levels of activated NovoThirteen, thereby increasing the risk of thrombosis (formation of blood clots in the blood vessels), and information on administration procedures, since the factor XIII concentration in NovoThirteen is different from other factor XIIIcontaining medicines.
Danish: Oplysningerne skal omfatte opbevaringsanvisninger, da ukorrekt opbevaring efter opløsning af pulveret kan medføre højere koncentrationer af aktiveret NovoThirteen og dermed øget risiko for trombose (dannelse af blodpropper i blodkarrene).
English: A specific component of factor XIII called the A-subunit is involved in stabilising blood clots and increasing the strength of the clot.
Danish: En særlig komponent i faktor XIII er den såkaldte A-subunit, der stabiliserer og styrker blodklumper.
English: NovoThirteen does not work in patients lacking the factor XIII B-subunit.
Danish: NovoThirteen virker ikke, hvis patienten mangler faktor XIII Bsubunit.
English: NovoThirteen works by providing the factor XIII A-subunit, which helps to prevent bleeding in these patients.
Danish: NovoThirteen virker ved at tilføre faktor XIII A-subunit, hvilket har forebyggende virkning mod blødning.
English: NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called ‘congenital factor XIII A-subunit deficiency'.
Danish: NovoThirteen anvendes til forebyggende langtidsbehandling af blødning hos patienter med medfødt mangel på faktor XIII A-subunit.
English: How has NovoThirteen been studied?
Danish: Hvordan blev NovoThirteen undersøgt?
English: What benefit has NovoThirteen shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved NovoThirteen?
English: On average, there were approximately 0.15 bleeding episodes requiring factor XIII treatment per year per patient treated preventatively with NovoThirteen.
Danish: Hos de patienter, som fik forebyggende behandling med NovoThirteen, forekom der pr. år pr. patient gennemsnitligt ca. 0,15 blødningsepisoder, der gjorde det nødvendigt at behandle med faktor XIII.
English: It is available as a powder and solvent to be made up into a solution for injection.
Danish: Det fås som et pulver, der opløses i den medfølgende væske og derefter gives som injektion.
English: The factor XIII A-subunit in NovoThirteen is made by a method known as ‘recombinant DNA technology': it is produced by yeast cells that have received the gene (DNA) which makes the cells able to produce it.
Danish: Det produceres af gærceller, der har fået indsat et gen (dna), som gør dem i stand til at producere stoffet.
English: What is NovoThirteen used for?
Danish: Hvad anvendes NovoThirteen til?
English: How is NovoThirteen used?
Danish: Hvordan anvendes NovoThirteen?
English: How does NovoThirteen work?
Danish: Hvordan virker NovoThirteen?
English: The study looked at the number of bleeding episodes requiring treatment with a factor XIII-containing medicine in these patients, compared with patients who had not received NovoThirteen, based on earlier data from 16 patients with congenital factor XIII A-subunit deficiency.
Danish: Dette antal blev sammenholdt med tidligere oplysninger om 16 patienter, der havde medfødt mangel på faktor XIII A-subunit, men ikke havde fået NovoThirteen.
English: The recommended dose is one tablet once a week.
Danish: Den anbefalede dosis er én tablet én gang om ugen.
English: The name of the medicine was changed to Vantavo on 26 March 2010.
Danish: Lægemidlets navn blev ændret til Vantavo den 26. marts 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Vantavo.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vantavo.
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Fosavance i 2005 («informeret samtykke»).
English: The full EPAR for Vantavo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Vantavo findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Vantavo is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vantavo anvendes så sikkert som muligt.
English: The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Vantavo er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse..
English: the day, which should be at least 30 minutes after taking the tablet.
Danish: dagens første måltid, som skal indtages mindst 30 minutter efter tabletten.
English: What measures are being taken to ensure the safe and effective use of Vantavo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vantavo?
English: The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for alendronatnatrium og colecalciferol, MSD den 16. oktober 2009.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Danish: Patienten skal tage tabletten sammen med et helt glas vand (men ikke mineralvand), mindst 30 minutter før indtagelse af mad, drikke eller andre lægemidler (herunder antacider, calciumtilskud og vitaminer).
English: For more information about treatment with Vantavo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vantavo, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek .
English: Vantavo reduces the risk of broken bones in the spine and the hip.
Danish: Vantavo mindsker risikoen for knoglebrud i rygsøjlen og hoften.
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 Vantavo.
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 Vantavo skal anvendes.
English: Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Danish: D3-vitamin er et næringsstof, der findes i visse fødevarer, men som også dannes i huden, når den udsættes for almindeligt sollys.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Vantavo.
Danish: Da patienter med osteoporose muligvis ikke får tilstrækkeligt med D3-vitamin via eksponering for sollys, indeholder Vantavo dette vitamin.
English: What is the risk associated with Vantavo?
Danish: Hvilken risiko er der forbundet med Vantavo?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantavo, 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 Vantavo, herunder passende forholdsregler, som patienter og sundhedspersonale bør følg
English: Other information about Vantavo:
Danish: Andre oplysninger om Vantavo
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Danish: Da alendronsyre og D3-vitamin allerede anvendes særskilt i godkendte lægemidler i EU, fremlagde virksomheden data, som var indsamlet i tidligere undersøgelser, og data fra den offentliggjorte faglitteratur om kvinder, som havde været gennem overgangsalderen og tog alendronsyre og Dvitamin som separate tabletter.
English: Vantavo 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements.
Danish: Vantavo 70 mg/5 600 IE anvendes til patienter, der ikke tager vitamin Dtilskud.
English: Vantavo must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Danish: Vantavo må ikke anvendes til patienter med abnormiteter i spiserøret (øsofagus), patienter med hypocalcæmi (lavt calciumindhold i blodet) eller patienter, som ikke kan stå eller sidde op i mindst 30 minutter.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Vantavo was the same as the dose needed to prevent bone loss.
Danish: De oplysninger, som virksomheden fremlagde fra tidligere undersøgelser og fra den offentliggjorte faglitteratur, viste, at dosis af alendronsyre i Vantavo svarede til den dosis, der krævedes for at forebygge tab af knoglemasse.
English: Vantavo (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Danish: Vantavo (indeholder enten 2 800 eller 5 600 IE colecalciferol) anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos kvinder efter overgangsalderen, som har risiko for lave D-vitaminniveauer.
English: Why has Vantavo been approved?
Danish: Hvorfor blev Vantavo godkendt?
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels.
Danish: Til understøttelse af kombinationen af alendronsyre og D-vitamin i samme tablet gennemførte virksomheden ligeledes en undersøgelse af 717 patienter med osteoporose, herunder 682 kvinder efter overgangsalderen, for at påvise, at Vantavo er i stand til øge D-vitamin-niveauerne.
English: It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Danish: Det fås som tabletter (70 mg alendronsyre og 2 800 internationale enheder [IE] colecalciferol, 70 mg alendronsyre og 5 600 IE colecalciferol).
English: For the full list of all side effects reported with Vantavo, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Vantavo fremgår af indlægssedlen.
English: After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Danish: Efter 15 uger havde færre patienter lave D-vitaminniveauer, når de fik Vantavo 70 mg/2 800 IE (11 %), end når de kun fik alendronsyre (32 %).
English: The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Danish: De hyppigste bivirkninger ved Vantavo er mavesmerter, dyspepsi (halsbrand), øsofagus-ulcus (sår i spiserøret), dysfagi (synkebesvær), udspilet mave og syreregurgitation (sure opstød).
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU).
Danish: Denne undersøgelse blev udvidet til at omfatte 652 patienter i yderligere 24 uger med henblik på at sammenligne virkningerne af at fortsætte med Vantavo 70 mg/2 800 IE alene eller ved tilføjelse af 2 800 IE D3-vitamin (svarende til at anvende Vantavo 70 mg/5 600 IE).
English: In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Danish: I den udvidede undersøgelse havde et tilsvarende antal patienter, som tog Vantavo 70 mg/2 800 IE og Vantavo 70 g/5 600 IE, lave D-vitamin-niveauer (under 6 %), men de patienter, der tog Vantavo 70 mg/5 600 IE, havde en større stigning i D-vitamin-niveauerne i løbet af de 24 uger, undersøgelsen varede.
English: Patients received either Vantavo 70 mg/2,800 IU or alendronic acid only once a week.
Danish: Patienterne fik enten Vantavo 70 mg/2 800 IE eller alendronsyre én gang om ugen.
English: 1 Previously known as Alendronate Sodium And Colecalciferol, MSD.
Danish: Tidligere kendt som alendronatnatrium og colecalciferol, MSD.
English: Vantavo is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Vantavo er et lægemiddel, der indeholder to aktive stoffer: alendronsyre og colecalciferol (D3-vitamin).
English: What is Vantavo?
Danish: Hvad er Vantavo?
English: Vantavo alendronic acid and colecalciferol
Danish: Vantavo alendronsyre og colecalciferol
English: Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Danish: Vantavo indeholder to aktive stoffer: alendronsyre og colecalciferol (D3-vitamin).
English: What is Vantavo used for?
Danish: Hvad anvendes Vantavo til?
English: How has Vantavo been studied?
Danish: Hvordan blev Vantavo undersøgt?
English: What benefit has Vantavo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Vantavo?
English: How is Vantavo used?
Danish: Hvordan anvendes Vantavo?
English: How does Vantavo work?
Danish: Hvordan virker Vantavo?
English: For the full list of restrictions, see the package leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of
Danish: For at undgå irritation af spiserøret (øsofagus) bør patienten undgå at ligge ned inden
English: Packaging
Danish: Tilbageholdelsestid
English: Target species Route of administration
Danish: EU-nummer Særnavn Styrke Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: 9 July 2001
Danish: 20. juli 2001
English: differences on the molecular level may exist.
Danish: kan være forskelle på det molekylære niveau.
English: See the Module ”All authorised presentations”
Danish: Se modulet ”All authorised presentations”
English: Active substance:
Danish: Aktivt indholdsstof:
English: Antibacterial for systemic use JO1
Danish: Antibakteriel systemisk anvendelse JO1
English: Date of issue of Marketing Authorisation valid throughout the European Union:
Danish: Dato for udstedelse af markedsføringstilladelsen gyldig i hele den Europæiske Union: