FrancophonIA/ELRC3.0 huggingface dataset:
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Danish: RANKL er med til at aktivere osteoklaster, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevæv.
English: Prolia was also more effective at reducing the number of women who had fractures elsewhere in the body, including in the hip.
Danish: Prolia var også mere effektivt til at mindske antallet af kvinder, der fik brud andre steder i kroppen, herunder i hoften.
English: Why is Prolia authorised in the EU?
Danish: Hvorfor blev Prolia godkendt i EU?
English: In addition, after 3 years the risk of new spine fractures was lower in patients who received Prolia.
Danish: Desuden var risikoen for nye rygsøjlebrud efter tre år lavere hos patienter, der fik Prolia.
English: Prolia is available as a solution for injection in prefilled syringes, each containing 60 mg denosumab.
Danish: Prolia fås som injektionsvæske i fyldte sprøjter, der hver indeholder 60 mg denosumab.
English: What are the risks associated with Prolia?
Danish: Hvilke risici er der forbundet med Prolia?
English: Uncommon or rare cases of cellulitis (inflammation of deep skin tissue), hypocalcaemia (low blood calcium), hypersensitivity (allergy), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and unusual fractures of the thigh bone have been seen in patients taking Prolia.
Danish: Der er observeret ikke almindelige eller sjældne tilfælde af cellulitis (betændelse i de dybereliggende væv under huden), lavt kalciumindhold i blodet, allergi, osteonekrose (beskadigelse af kæbebenene, der kan medføre smerter, sår i munden eller løse tænder) og usædvanlige brud i lårbenet hos patienter, der tager Prolia.
English: The most common side effects with Prolia (seen in more than 1 patient in 10) are pain in the arms or legs, and bone, joint and muscle pain.
Danish: De hyppigste bivirkninger ved Prolia (som optræder hos flere end 1 ud af 10 patienter) er smerter i arme, ben og knogler samt led- og muskelsmerter.
English: For the full list of side effects and restrictions with Prolia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Prolia fremgår af indlægssedlen.
English: Prolia must not be used in people with hypocalcaemia (low blood calcium levels).
Danish: Prolia må ikke gives til patienter med lavt kalciumindhold i blodet.
English: • bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection.
Danish: • knogletab hos voksne, der har en øget risiko for knoglebrud, og som er i langvarig behandling med kortikosteroid-lægemidler, der gives gennem munden eller som injektion.
English: Prolia has been compared with placebo in one main study involving 242 men with osteoporosis.
Danish: Prolia blev sammenlignet med placebo i et hovedstudie af 242 mænd med knogleskørhed.
English: Prolia reduces the risk of fractures in the spine;
Danish: Prolia mindsker risikoen for brud i rygsøjlen
English: In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip;
Danish: Hos kvinder, som har været gennem overgangsalderen, reducerer Prolia risikoen for brud i rygsøjlen og andre steder i kroppen, herunder hoften
English: In the first of these studies, 2% of the women receiving Prolia had a new spine fracture after 3 years of treatment compared with 7% of the women receiving placebo.
Danish: I det første af disse studier fik 2 % af de kvinder, der fik Prolia, et nyt brud på rygsøjlen efter 3 års behandling sammenlignet med 7 % af de kvinder, der fik placebo.
English: Bone loss in adults receiving long-term corticosteroid therapy
Danish: Knogletab hos voksne, der er i langvarig behandling med kortikosteroider
English: Osteoporosis in women
Danish: Knogleskørhed hos kvinder
English: • bone loss in men receiving treatment for prostate cancer that increases their risk of fracture.
Danish: • tab af knoglemasse hos mænd, der får en behandling for prostatakræft, som øger risikoen for brud.
English: Women who took Prolia had higher bone density (a measure of how strong the bones are) in the lumbar (lower) spine after 1 year of treatment than women on placebo.
Danish: Kvinder, der fik Prolia, havde højere knogletæthed (et mål for, hvor stærke knoglerne er) i den nederste del af rygsøjlen efter 1 års behandling end de kvinder, der havde fået placebo.
English: • osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones).
Danish: • osteoporose (knogleskørhed) hos kvinder, som har været gennem overgangsalderen, og hos mænd, som har forhøjet risiko for knoglebrud.
English: Bone loss in men receiving treatment for prostate cancer
Danish: Knogletab hos mænd, der får behandling for prostatakræft
English: How is Prolia used?
Danish: Hvordan anvendes Prolia?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prolia have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Prolia.
English: In men who took Prolia bone density increased by 5.7% after 1 year of treatment compared with a 0.9% increase in men who took placebo.
Danish: Hos de mænd, der fik Prolia, blev knogletætheden øget med 5,7 % efter ét års behandling sammenholdt med en stigning på 0,9 % hos dem, der fik placebo.
English: In patients who had been treated with corticosteroids for up to 3 months before the study, bone density in the lumbar spine increased by 3.1% after 1 year of treatment with Prolia compared with a 0.8% increase with risedronate.
Danish: Hos patienter, der blev behandlet med kortikosteroider i op til 3 måneder før studiet, steg knogletætheden i lændehvirvelsøjlen med 3,1 % efter et års behandling med Prolia sammenholdt med en stigning på 0,8 % med risedronat.
English: What benefits of Prolia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Prolia?
English: In patients who had been treated with corticosteroids for more than 3 months before the study, lumbar spine bone density increased by 3.6% after 1 year of treatment with Prolia compared with a 2.0% increase with risedronate.
Danish: Hos patienter, der blev behandlet med kortikosteroider i mere end 3 måneder før studiet, steg knogletætheden i lændehvirvelsøjlen med 3,6 % efter et års behandling med Prolia sammenholdt med en stigning på 2,0 % med risedronat.
English: After 2 years, men who received Prolia had an increase in bone density in the lumbar spine that was 7% higher than in those who received placebo.
Danish: Efter to år havde mænd, som blev behandlet med Prolia, en øget knogletæthed i lændehvirvelsøjlen, som var 7 % større end hos dem, der fik placebo.
English: How does Prolia work?
Danish: Hvordan virker Prolia?
English: Prolia is given once every 6 months as a 60 mg injection under the skin in the thigh, abdomen (belly) or back of the arm. During treatment with Prolia, the doctor should ensure that the patient is receiving calcium and vitamin D supplements.
Danish: Prolia gives hver sjette måned som en injektion af 60 mg under huden i låret, maven eller på bagsiden af armen.
English: Osteoporosis in men
Danish: Knogleskørhed hos mænd
English: Prolia has been shown to be more effective than risedronate (a bisphosphonate medicine) at increasing bone density in one main study involving 795 adults treated with corticosteroid medicines.
Danish: Det er i et hovedstudie med 795 voksne i behandling med kortikosteroider påvist, at Prolia er mere effektivt end risedronat (et bisfosfonat-lægemiddel) til at øge knogletætheden.
English: Prolia has been shown to be more effective than placebo at treating bone loss in one main study involving 1,468 men receiving treatment for prostate cancer who were at an increased risk of fracture.
Danish: Et hovedstudie med 1 468 mænd, der fik behandling for prostatakræft, og som havde en øget risiko for knoglebrud, har påvist, at Prolia er mere effektivt end placebo til at behandle knogletab.
English: Prolia has been shown to be more effective than placebo (a dummy treatment) at reducing fractures in two main studies involving a total of over 8,000 women with osteoporosis who had been through the menopause.
Danish: Det er i to hovedstudier med over 8 000 kvinder med knogleskørhed, som var gennem overgangsalderen, påvist, at Prolia er mere effektivt end placebo (ikke-aktivt stof) til at reducere knoglebrud.
English: This summary was last updated in December 2018.
Danish: Dette sammendrag blev sidst ajourført i december 2018.
English: The local reactions lasted up to 25 days.
Danish: De lokale reaktioner varede i op til 25 dage.
English: A booster is required after 12 months.
Danish: Der kræves en booster efter 12 måneder.
English: The serotype to be used in the vaccine is selected before manufacture depending on which type is circulating and causing disease at the time.
Danish: Den serotype, der skal anvendes i vaccinen, udvælges inden fremstillingen på grundlag af, hvilken type der cirkulerer og forårsager sygdommen på det tidspunkt.
English: Zulvac BTV received a marketing authorisation valid throughout the EU on 25 April 2017.
Danish: Zulvac BTV fik en markedsføringstilladelse med gyldighed i hele EU den 25. april 2017.
English: Further information on Zulvac BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
Danish: Yderligere information om Zulvac BTV findes på agenturets websted under: ema.europa.eu/medicines/veterinary medicines/EPAR/zulvac-btv.
English: The withdrawal period for meat and milk from sheep and cattle treated with Zulvac BTV is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og mælk fra får og kvæg, der behandles med Zulvac BRV, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and Quil-A) that enhance the response of the immune system.
Danish: Vaccinen indeholder også "adjuvanser" (aluminiumhydroxid og Quil-A), som giver en bedre immunrespons.
English: The name of the medicine was changed to Zulvac BTV on 21 February 2019.
Danish: Lægemidlets navn blev ændret til Zulvac BTV den 21. februar 2019.
English: The vaccine is available as a suspension for injection and can only be obtained with a prescription.
Danish: Vaccinen fås som en suspension til injektion og udleveres kun efter recept.
English: The vaccine is given as two injections under the skin for sheep and in the muscle for cattle.
Danish: Vaccinen gives som to injektioner under huden hos får og i musklen hos kvæg.
English: In most cases the reactions are diffuse swellings at the injection site which last no longer than one week.
Danish: I de fleste tilfælde er reaktionerne diffuse hævelser på injektionsstedet, som forsvinder i løbet af en uge.
English: Data on the effectiveness under field conditions of other bluetongue virus vaccines containing the individual serotypes or a combination of two serotypes were also taken into account.
Danish: Oplysninger om virkningen under feltbetingelser af andre bluetonguevirusvacciner, der indeholder enkelte serotyper eller en kombination af to serotyper, blev også taget med i betragtning.
English: When it is given to sheep or cattle, their immune system recognises
Danish: Når det gives til får eller kvæg, registrerer deres
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Danish: Det er også den tid, der skal gå efter indgivelsen af et lægemiddel, før mælken kan anvendes til menneskeligt konsum.
English: They may also be nodules that can be felt under the skin of up to 60 cm2 in size which reduce with time but may persist for more than 50 days.
Danish: Der kan også dannes knuder under huden på op til 60 cm2, som mindskes med tiden, men der kan godt gå over 50 dage, inden de er forsvundet.
English: Protection lasts for one year for both serotype 1 and 8.
Danish: Beskyttelsen varer et år for både serotype 1 og 8.
English: The vaccine can prevent the presence of serotypes 1 or 8 in the blood and reduce levels of serotype 4.
Danish: Vaccinen kan forhindre tilstedeværelsen af serotype 1 eller 8 i blodet og mindske niveauerne af serotype 4.
English: The European Medicines Agency decided that Zulvac BTV' benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Zulvac BTV opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Zulvac BTV, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Zulvac BTV, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: the virus as ‘foreign' and makes antibodies against it.
Danish: immunsystem virussen som "fremmed" og reagerer ved at danne antistoffer mod det.
English: The first injection is given from 6 weeks of age for sheep and from 12 weeks of age for cattle; and a second injection is given 3 weeks later.
Danish: Den første injektion gives fra 6-ugersalderen hos får og fra 12-ugersalderen hos kvæg, og for begge disse gives der endnu en injektion tre uger senere.
English: Zulvac BTV is a vaccine.
Danish: Zulvac BTV er en vaccine.
English: Zulvac BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges.
Danish: Zulvac BTV er en vaccine, der anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, en infektion forårsaget af bluetonguevirus, som overføres gennem mitter.
English: The vaccine contains inactivated (killed) bluetongue virus.
Danish: Vaccinen indeholder inaktiveret (dræbt) bluetonguevirus.
English: An overview of Zulvac BTV and why it is authorised in the EU
Danish: Oversigt over Zulvac BTV, og hvorfor det er godkendt i EU
English: 1 Previously known as Zulvac BTV Ovis.
Danish: 1 Tidligere kendt som Zulvac BTV Ovis.
English: The most common side effects with Zulvac BTV in cattle (which may affect more than 1 in 10 animals) are local reactions at the injection site and a short-lived increase in body temperature, up to 2.7˚C, during the 2 days after vaccination.
Danish: De hyppigste bivirkninger ved Zulvac BTV hos kvæg (som kan forekomme hos mere end 1 ud af 10 dyr) er lokale reaktioner på injektionsstedet og en kortvarig stigning i kropstemperaturen på op til 2,7 ˚C i to dage efter vaccinationen.
English: Zulvac BTV contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Danish: Zulvac BTV indeholder bluetonguevirus, som er blevet inaktiveret, så den ikke kan fremkalde sygdommen.
English: The most common side effects with Zulvac BTV in sheep (which may affect more than 1 in 10 animals) are a short-lived increase in body temperature, up to 1.6˚C, during the 2 days after vaccination and local reactions at the injection site.
Danish: De hyppigste bivirkninger ved Zulvac BTV (som kan forekomme hos mere end 1 ud af 10 dyr) er en kortvarig stigning i kropstemperaturen på op til 1,6 ˚C i to dage efter vaccinationen og lokale reaktioner på injektionsstedet.
English: Zulvac BTV (inactivated bluetongue vaccine containing either serotype 1, 4 or 8)1
Danish: Zulvac BTV (inaktiveret bluetonguevaccine, der indeholder enten serotype 1, 4 eller 8)1
English: Further laboratory studies showed protection lasts for one year for each serotype.
Danish: Yderligere laboratoriestudier viste, at beskyttelsen varer i et år for hver serotype.
English: A laboratory study with lambs vaccinated with serotype 4 showed the vaccine to reduce levels of serotype 4 in the blood for at least 12 months whilst studies with serotype 1 and 8 showed absence of the respective serotypes after one year.
Danish: Et laboratoriestudie med lam vaccineret med serotype 4 viste, at vaccinen mindskede niveauet af serotype 4 i blodet i mindst 12 måneder, mens studier med serotype 1 og 8 viste, at disse to serotyper helt var forsvundet efter et år.
English: When used in sheep the vaccine contains one of the following three vaccine strains: BTV serotype 1, BTV serotype 4 and BTV serotype 8.When used in cattle the vaccine contains either BTV serotype 1 or BTV serotype 8.
Danish: Når vaccinen anvendes hos får, indeholder den en af følgende tre vaccinestammer: BTV serotype 1, BTV serotype 4 og BTV serotype 8.
English: What is Zulvac BTV and what is it used for?
Danish: Hvad er Zulvac BTV, og hvad anvendes det til?
English: For sheep protection starts 3 weeks after the initial course of two injections and lasts for one year.
Danish: Hos får starter beskyttelsen tre uger efter de indledende to injektioner og varer i et år.
English: Laboratory studies were conducted with the individual serotypes 1, 4 and 8 as well as with the combination of 1 and 8 in sheep which showed that protection starts three weeks after completion of the initial course of two injections for each serotype.
Danish: Der blev gennemført laboratoriestudier med henholdsvis serotype 1, 4 og 8 samt med kombinationen af 1 og 8 hos får, som viste, at beskyttelsen starter tre uger efter afslutningen af den indledende behandling med to injektioner for hver serotype.
English: Further laboratory studies showed protection lasts for one year for the respective serotypes.
Danish: Yderligere laboratoriestudier viste, at beskyttelsen varer i et år for begge serotyper.
English: For cattle protection starts 15 days after the initial course of two injections for serotype 1 whilst protection starts 25 days after the initial course of two injections for serotype 8.
Danish: Hos kvæg starter beskyttelsen 15 dage efter de indledende to injektioner for serotype 1, og for serotype 8 starter den 25 dage efter de indledende to injektioner.
English: What are the risks associated with Zulvac BTV?
Danish: Hvilken risiko er der forbundet med Zulvac BTV?
English: Why is Zulvac BTV authorised in the EU?
Danish: Hvorfor blev Zulvac BRV godkendt i EU?
English: Other information about Zulvac BTV?
Danish: Andre oplysninger om Zulvac BTV
English: Laboratory studies were conducted with the individual serotypes 1 and 8 in cattle which showed that protection starts 15 days after completion on the initial vaccination course of two injections for serotype 1 and 25 days after completion of the initial vaccination course for serotype 8.
Danish: Der blev gennemført laboratoriestudier med henholdsvis serotype 1 og 8 hos kvæg, som viste, at beskyttelsen starter 15 dage efter det indledende vaccinationsforløb med to indsprøjtninger for serotype 1, og 25 dage efter det indledende vaccinationsforløb for serotype 8.
English: Zulvac BTV contains bluetongue virus of one type selected from serotypes 1, 4 and 8.
Danish: Zulvac BTV indeholder bluetonguevirus af enten serotype 1, 4 eller 8.
English: How is Zulvac BTV used?
Danish: Hvordan anvendes Zulvac BTV?
English: How does Zulvac BTV work?
Danish: Hvordan virker Zulvac BTV?
English: What benefits of Zulvac BTV have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zulvac BTV?
English: Overall summary of the scientific evaluation of Simvastatin Vale and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Simvastatin Vale og tilknyttede navne (se bilag I)
English: • the CHMP reviewed the available data submitted by the Applicant
Danish: • CHMP gennemgik de tilgængelige data, der var indsendt af ansøgeren,
English: Scientific conclusions and grounds for positive opinion
Danish: Videnskabelige konklusioner og begrundelse for den positive udtalelse
English: The CHMP noted that the proposed formulations are largely identical qualitatively and quantitatively and are manufactured according to the same process.
Danish: CHMP bemærkede, at de ansøgte formuleringer stort set er kvalitativt og kvantitativt identiske og fremstilles ved samme proces.
English: In conclusion, the CHMP was of the opinion that the benefit-risk ratio of Simvastatin Vale and associated names is favourable.
Danish: Endelig var CHMP af den opfattelse, at risk/benefit-forholdet for Simvastatin Vale og tilknyttede navne er positivt.
English: Finally, the CHMP considered the bioanalytical method used to be sufficiently validated and in line with the bioequivalence guideline.
Danish: Endelig anså CHMP den anvendte bioanalytiske metode for at være tilstrækkeligt valideret og i overensstemmelse med bioækvivalensvejledningen.
English: The CHMP also evaluated the in vitro dissolution data, noting that both products showed rapid and high dissolution levels at pH 7 and that solubility was therefore unlikely to be a limiting factor.
Danish: CHMP vurderede desuden in vitro-opløselighedsdata, og bemærkede, at begge produkter er hurtigt og højt opløselige ved pH 7, og at opløseligheden derfor ikke kunne forventes at være en begrænsende faktor.
English: The CHMP considered that the pharmacokinetics of simvastatin are fully linear across the therapeutic dose range, that simvastatin is well absorbed and that no significant differences in absorption between the proposed and the reference product could be identified.
Danish: CHMP tog hensyn til, at farmakokinetikken for simvastatin er fuldt lineær i hele det terapeutiske dosisområde, at simvastatin absorberes godt, og at der ikke kunne konstateres væsentlig forskel i absorption mellem det ansøgte produkt og referenceproduktet.
English: The marketing authorisation application for a generic simvastatin oral suspension to be marketed as Simvastatin Vale 20 mg/5 ml and 40 mg/5 ml and indicated in the treatment of hypercholesterolemia and cardiovascular disease prevention was supported by a single bioequivalence study comparing the 20 mg/5 ml oral suspension to the 20 mg immediate release tablet of the reference product.
Danish: Ansøgningen om markedsføringstilladelse for en generisk oral suspension af simvastatin, der skal markedsføres som Simvastatin Vale, 20 mg/5 ml og 40 mg/5 ml, og er indiceret til behandling af hyperkolesterolæmi og forebyggelse af kardiovaskulær sygdom, blev støttet af en enkelt bioækvivalensundersøgelse, der sammenlignede den orale suspension, 20 mg/5 ml, med referenceproduktet, en 20 mg tablet med umiddelbar udløsning.
English: Following potential serious risks to public health raised regarding the evidence of bioequivalence for the higher 40 mg/5 ml strength, a referral under Article 29(4) of Directive 2001/83/EC was triggered, requesting the CHMP to give its opinion on whether Simvastatin is bioequivalent to the reference product.
Danish: Efter at der var rejst betænkelighed ved potentiel alvorlig risiko for den offentlige sundhed vedrørende dokumentationen for bioækvivalens af den højere styrke på 40 mg/5 ml, blev der indledt en indbringelsesprocedure i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, idet CHMP blev anmodet om at fremsætte en udtalelse om, hvorvidt Simvastatin er bioækvivalent med referenceproduktet.