FrancophonIA/ELRC3.0 huggingface dataset:
English: The average effectiveness of VarroMed to kill mites (measured by the number of dead mites found at the bottom of the hive) was 88% for winter, 92% for spring and 85% for autumn treatments.
Danish: VarroMed-behandlingens gennemsnitlige effektivitet med hensyn til at dræbe mider (målt på antal døde mider fundet på stadets bundbræt) var 88 % om vinteren, 92 % om foråret og 85 % om efteråret.
English: VarroMed is intended to be used as part of an integrated varroa control programme, which includes other techniques.
Danish: VarroMed er beregnet til brug som led i et integreret program til Varroa-kontrol, der omfatter andre teknikker.
English: The effectiveness of VarroMed was investigated in field studies in European countries with different climates, both continental climate and Mediterranean climate.
Danish: VarroMeds virkning blev undersøgt i feltundersøgelser i europæiske lande med forskellige klimaforhold, både fastlandsklima og middelhavsklima.
English: Varroa mite and honey bee mortality were monitored twice weekly for 4 weeks during treatment until one week after treatment.
Danish: Mideog bidødeligheden blev overvåget to gange om ugen i fire uger under behandlingen og indtil en uge efter behandlingen.
English: The most common side effect with VarroMed (which may affect more than 1 in 10 bee colonies) is an increased number of deaths of worker bees.
Danish: Den hyppigste bivirkning ved VarroMed (som kan optræde hos mere end 1 ud af 10 dyr) er en øget dødelighed hos arbejdsbier.
English: The withdrawal period for honey from honey bees treated with VarroMed for is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for honning fra bier, der behandles med VarroMed, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: In case of accidental spillage onto skin, the affected areas should be washed immediately with running water.
Danish: Ved utilsigtet spild på huden skal de pågældende områder straks skylles med rindende vand.
English: Treatment should be given in the late afternoon or evening when bees are less likely to be flying.
Danish: Behandlingen bør gives sent om eftermiddagen eller om aftenen, når biernes flyveaktivitet er lav.
English: What is VarroMed and what is it used for?
Danish: Hvad er VarroMed, og hvad anvendes det til?
English: It can be used either as a single-dose treatment during the broodless period (winter treatment), or in the presence of brood (spring or autumn treatment) which will usually require repeated treatments.
Danish: Det kan enten bruges som enkeltdosisbehandling i perioden uden yngel (vinterbehandling), eller mens der er yngel (forårs- eller efterårsbehandling), hvilket normalt kræver gentagne behandlinger.
English: Why is VarroMed approved?
Danish: Hvorfor er VarroMed blevet godkendt?
English: It is not intended to provide practical advice on how to use VarroMed.
Danish: Det er ikke en praktisk vejledning i, hvordan VarroMed bør anvendes.
English: The groups were treated during winter (in the absence of brood), spring and autumn (in the presence of brood) and included colonies of different sizes (5,000 to 30,000 bees) and different infestation levels.
Danish: Grupperne blev behandlet om vinteren (uden yngel) og om foråret og efteråret (med yngel) og omfattede familier af forskellig størrelse (5 000-30 000 bier) og forskellig andel af mideangreb.
English: Other information about VarroMed?
Danish: Andre oplysninger om VarroMed?
English: The dose is adjusted to the colony size.
Danish: Dosis skal tilpasses bifamiliens størrelse.
English: In case of accidental spillage into the eye(s) flush the eye(s) immediately with clear running water for 10 minutes.
Danish: Ved utilsigtet spild i øjnene skal øjnene straks skylles med rent rindende vand i 10 minutter.
English: People should avoid contact with the skin, eyes and mucous membranes (moist body surfaces such as lining of mouth).
Danish: Undgå kontakt med hud, øjne og slimhinder (fugtige overflader på kroppen, fx munden).
English: Children should be kept from contact with VarroMed.
Danish: Børn må ikke komme i berøring med VarroMed.
English: What are the risks associated with VarroMed?
Danish: Hvilke risici er der forbundet med VarroMed?
English: VarroMed must not be given during nectar flow, when honey is produced by bees, and should not be used when honey chambers are attached to the hive.
Danish: VarroMed må ikke bruges under træk (af nektar), når bierne producerer honning, og bør ikke bruges, når der er fastgjort honningkar på stadet.
English: VarroMed oxalic acid dihydrate / formic acid
Danish: VarroMed oxalsyredihydrat/myresyre
English: VarroMed contains the active substances oxalic acid dihydrate and formic acid.
Danish: VarroMed indeholder de aktive stoffer oxalsyredihydrat, og myresyre.
English: VarroMed is a medicine used to treat varroosis in honey bee colonies.
Danish: VarroMed er et lægemiddel, der anvendes til at behandle varroatose hos honningbifamilier.
English: The activity of oxalic acid on mites is thought to be due to the acidity of the medicine.
Danish: Oxalsyres virkning på mider antages at skyldes lægemidlets surhed.
English: VarroMed can be used on colonies with and without brood.
Danish: VarroMed kan anvendes til behandling af bifamilier med og uden yngel.
English: VarroMed is available as a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Danish: VarroMed fås som bistadedispersion (en væske til brug inde i bistadet) uden recept.
English: Formic acid is thought to kill Varroa mites by blocking the ability of their cells to generate energy; it may also act on mite nerve cells.
Danish: Myresyre dræber antagelig Varroa-mider ved at hæmme deres cellers evne til at producere energi.
English: The Varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in damage and / or death of bees; the mite can also help spread of viruses and bacteria.
Danish: Varroa-miden lever af hæmolymfe (blod) fra voksne bier og yngel (honningbiens udviklingsstadier), hvilket er skadeligt og/eller dødeligt for bien.
English: A significant mite infestation can lead to the collapse of a honey bee colony.
Danish: Et alvorligt mideangreb kan få bifamilien til at bryde sammen.
English: Accidental ingestion may cause adverse reactions.
Danish: Utilsigtet indtagelse kan give bivirkninger.
English: People who are hypersensitive (allergic) to formic acid or oxalic acid should give the medicine with caution.
Danish: Personer med kendt overfølsomhed for myresyre eller oxalsyre bør udvise forsigtighed, når de anvender veterinærlægemidlet
English: Protective clothing, acid-resistant gloves and glasses should be worn during treatment.
Danish: Ved håndtering af veterinærlægemidlet bør anvendes personlige værnemidler bestående af beskyttelsesdragt, syrebestandige handsker og beskyttelsesbriller.
English: For more information about treatment with VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med VarroMed, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is VarroMed used?
Danish: Hvordan anvendes VarroMed?
English: VarroMed is trickled onto bees in the brood chamber of the hive.
Danish: VarroMed dryppes på bierne i bistadets ynglerum.
English: For practical information about using VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af VarroMed, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: What benefits of VarroMed have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved VarroMed?
English: Varroosis is a disease of honey bees caused by infestation with a parasite called Varroa mite (Varroa destructor).
Danish: Den skyldes angreb af en snylter, der kaldes Varroa-miden (Varroa destructor).
English: How both oxalic acid and formic acid work is not well understood.
Danish: Det er ikke helt afdækket, hvordan oxalsyre og myresyre virker.
English: How does VarroMed work?
Danish: Hvordan virker VarroMed?
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
Danish: 10 ml (3,5 mg/ml) 5 (5 x 1) hætteglas (multipakning)
English: 10 ml (3.5 mg/ml) 2 vials
Danish: 3 ml (3,5 mg/ml) 10 (2 x 5) fyldte penne
English: The referral procedure was initiated on 19 May 2011.
Danish: Indbringelsesproceduren blev indledt den 19. maj 2011.
English: All children were Caucasian.
Danish: Alle børnene var af kaukasisk race.
English: Scientific conclusions and grounds for refusal presented by the EMA
Danish: Videnskabelige konklusioner og begrundelse for afslaget fremlagt af EMA
English: Puberty development is also delayed and often incomplete.
Danish: Desuden er pubertetsudviklingen forsinket og ofte ufuldstændig.
English: There were no deaths reported.
Danish: Der blev ikke indberettet om dødsfald.
English: The latter two may lead to childhood obesity.
Danish: De to sidstnævnte kan føre til fedme i barndommen.
English: PWS is a genetic disorder.
Danish: PWS er en genetisk sygdom.
English: The safety profile of somatropin-containing products is well known.
Danish: Sikkerhedsprofilen af produkter indeholdende somatropin er velkendt.
English: Data from 11 out of 41 children were too scarce to draw any conclusion on this endpoint.
Danish: Data for 11 ud af 41 børn var utilstrækkeligt til at drage konklusioner om dette endepunkt.
English: Even children who had only received one dose of Norditropin could be included.
Danish: Selv børn, der kun havde fået en enkelt dosis af Norditropin, kunne inkluderes.
English: Overall, the retrospective data collected were insufficient and of poor quality.
Danish: Overordnet var de retrospektive data utilstrækkelige og af ringe kvalitet.
English: Most females with PWS suffer from amenorrhea.
Danish: De fleste piger med PWS har amenoré.
English: The diagnosis is based on a genetic test and on clinical findings.
Danish: Diagnosen baseres på en genetisk test og kliniske fund.
English: Children with PWS often have concomitant growth hormone deficiency (GHD) (40 to 100%, depending on the provocation test used).
Danish: Børn med PWS har ofte ledsagende væksthormonmangel (GHD) (40 til 100 %, afhængigt af den anvendte provokationstest).
English: Another point of concern was the fact that based on the wording of the inclusion criteria it was doubtful whether all patients have been included in the study from the respective centres.
Danish: Desuden var der betænkelighed ved, at det ud fra ordlyden af inklusionskriterierne var tvivlsomt, om alle patienter er blevet inkluderet i undersøgelsen fra de respektive centre.
English: Norditropin was approved in accordance with Article 8(3) of Directive 2001/83/EC.
Danish: Norditropin blev godkendt i overensstemmelse med artikel 8, stk. 3, i direktiv 2001/83/EF.
English: The CHMP was requested to give its opinion on whether the marketing authorisations should be varied to include the indication:
Danish: CHMP blev anmodet om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne burde ændres, således at den omfattede følgende indikation:
English: Only 33 children were included in the primary efficacy analysis and selection bias cannot be excluded due to the design of the study.
Danish: Kun 33 børn blev inkluderet i den primære analyse af virkning, og selektionsbias kan ikke udelukkes på grund af undersøgelsens design.
English: However, the practice of data collection on body composition differed across the three centers.
Danish: Fremgangsmåden ved indsamlingen af data om kropssammensætning var imidlertid forskellig på de tre centre.
English: The incidence of PWS is 1 in about 10,000 to 29,000 live births.
Danish: Incidensen af PWS er 1 for hver 10 000 til 29 000 levendefødte.
English: Height velocity would also have been a valuable endpoint, however no data are available.
Danish: Væksthastighed ville ligeledes have været et værdifuldt endepunkt, men der forelå ingen data.
English: IGF-1 SDS at baseline was only available for 28 patients.
Danish: IGF-1 SDS ved baseline forelå kun for 28 patienter.
English: Safety was assessed by adverse events, HbA1c, IGF-I, haematology, TSH, total T3 and T4, free T3 and T4.
Danish: Sikkerheden blev vurderet ved bivirkninger, HbA1c, IGF-I, hæmatologi, TSH, totalt T3 og T4 samt frit T3 og T4.
English: There was no restriction on the degree of short stature and the children had to be pre-pubertal at start of treatment.
Danish: Der var ingen begrænsning i graden af kort statur, og børnene skulle være præ pubertale ved indledning af behandlingen.
English: Norditropin contains somatropin which is a human growth hormone produced by recombinant DNA technology that has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Danish: Norditropin indeholder somatropin, som er et humant væksthormon fremstillet ved rekombinant dna-teknologi og har modtaget markedsføringstilladelse i EU gennem den gensidige anerkendelsesprocedure (MRP).
English: One center did not collect body composition data at all and from the other two centers data were only available in 11 children.
Danish: På det ene center blev der slet ikke indsamlet data om kropssammensætning, og på de to andre centre forelå kun data for 11 børn.
English: The efficacy of Norditropin on key secondary endpoints such as body composition and height velocity is unknown.
Danish: Norditropins virkning på de vigtigste sekundære endepunkter som kropssammensætning og væksthastighed er ukendt.
English: • The Committee considered the notification of the referral triggered by Denmark under Article 13 of Commission Regulation (EC) No 1234/2008.
Danish: • udvalget behandlede anmeldelsen af den indbringelse, der var indledt at Danmark i henhold til artikel 13 i Kommissionens forordning (EF) nr. 1234/2008,
English: In the GHLiquid-1961 study forty-one (41) children in Europe with genetically documented PWS were enrolled (19 girls and 22 boys).
Danish: I undersøgelsen GHLiquid-1961 inkluderedes 41 børn i Europa med genetisk dokumenteret PWS (19 piger og 22 drenge).
English: “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
Danish: ”Forbedring af vækst og kropssammensætning hos børn med Prader-Willis syndrom (PWS) verificeret ved passende genetisk testning”.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 20 April 2011, Denmark triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Danish: Da referencemedlemsstaten og de berørte medlemsstater ikke kunne nå til enighed vedrørende ændringsansøgningen, indledte Danmark den 20. april 2011 en indbringelse i henhold til artikel 13 i Kommissionens forordning (EF) nr. 1234/2008.
English: In Europe, two recombinant GH products are approved for the treatment of children with PWS.
Danish: I Europa er to rekombinante væksthormonprodukter godkendt til behandling af børn med PWS.
English: Thus body composition would have been a key endpoint.
Danish: Kropssammensætning måtte derfor forventes at have været et hovedendepunkt.
English: Height at baseline was only available for 37 patients.
Danish: Højde ved baseline forelå kun for 37 patienter.
English: The CHMP concluded that given the retrospective design of the study, selection bias cannot be excluded.
Danish: CHMP konkluderede, at det på baggrund af undersøgelsens retrospektive design ikke kan udelukkes, at der har været tale om selektionsbias.
English: In order to demonstrate efficacy and safety in the applied indication, the application dossier was based on the study GHLiquid-1961.
Danish: Virkning og sikkerhed ved anvendelse til den ansøgte indikation var i ansøgningsdossieret dokumenteret med undersøgelsen GHLiquid-1961.
English: Apart from the aforementioned general deficiency some other aspects of the GHLiquid-1961 study raised concerns to the CHMP namely the validity and the quality of the study results and are summarised below.
Danish: Ved siden af ovennævnte generelle mangel var der visse andre aspekter af GHLiquid-1961undersøgelsen, der gav CHMP anledning til betænkelighed, nemlig undersøgelsesresultaternes validitet og kvalitet som sammenfattet nedenfor.
English: Data on change in height velocity were not considered valid, as data on pre-trial height measurements were incomplete.
Danish: Dataene om ændring i væksthastighed blev ikke anset for valide, da data om højdemålinger inden undersøgelsen var ufuldstændige.
English: The mean age at inclusion was 3.8 years (min 0.4 years; max 12.2 years).
Danish: Gennemsnitsalderen ved inklusion var 3,8 år (min. 0,4år; maks.
English: No additional information was given by the MAH on the other PWS children for which informed consent was not obtained.
Danish: Indehaveren af markedsføringstilladelsen gav ikke supplerende oplysninger om de andre børn med PWS, for hvilke der ikke blev opnået informeret samtykke.
English: Regarding efficacy on the basis of the available data the CHMP concluded that the demonstration of efficacy for Norditropin in PWS is based on limited and unreliable data of apparent poor quality.
Danish: Vedrørende virkning konkluderede CHMP på grundlag af de foreliggende data, at påvisningen af virkning af Norditropin ved PWS er baseret på begrænsede og upålidelige data af åbenbar ringe kvalitet.
English: The majority of events were of mild/moderate severity.
Danish: De fleste bivirkninger var af let til moderat sværhedsgrad.
English: The number of children with an HSDS above -2 was 19 (46%) children at baseline, 27 (66%) children after 1 year of treatment and 35 (85%) children at last observation.
Danish: Antallet af børn med HSDS over -2 var 19 (46 %) ved baseline, 27 (66 %) efter et års behandling og 35 (85 %) ved sidste observation.
English: Short stature, mental retardation, behavioural problems, hormonal dysfunctions, poor muscle tone and hyperphagia as well as hypoactivity are among its features.
Danish: Sygdommen kendetegnes af kort statur, mental retardering, adfærdsproblemer, hormonel dysfunktion, nedsat muskeltonus, hyperfagi og hypoaktivitet.
English: However, considering requests from some Concerned Member States (CMS) during the CMDh referral, the MAH agreed that the dose recommendation for PWS could be 0.035 mg/kg/day, the same as for the other two GH products approved in the same indication.
Danish: Efter anmodninger fra visse berørte medlemsstater under CMDh-indbringelsen tilsluttede indehaveren af markedsføringstilladelsen sig imidlertid, at den anbefalede dosis for PWS kunne være 0,035 mg/kg/dag, svarende til de to andre væksthormonprodukter, der er godkendt til samme indikation.
English: Sleep apnoea and sudden death have been reported in clinical practice after initiating therapy in patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Danish: Søvnapnø og pludselig død er indberettet fra klinisk praksis efter initiering af behandlingen hos patienter med Prader-Willis syndrom med en eller flere af følgende risikofaktorer: svær fedme, tidligere øvre luftvejsobstruktion eller søvnapnø, og uidentificeret luftvejsinfektion.
English: In conclusion, the data provided by the MAH in particular to support efficacy are insufficient to sustain the extension of indication in PWS.
Danish: Som konklusion er de af indehaveren af markedsføringstilladelsen forelagte data til støtte for virkningen utilstrækkelige til at underbygge udvidelsen af indikationen til PWS.
English: A total of 128 adverse events were reported in 31 (75.6%) children with PWS during Norditropin exposure (mean exposure 4.1 years, range 0.3 to 9.5 years).
Danish: Der blev i alt indberettet 128 tilfælde af bivirkninger hos 31 (75,6 %) af børn med PWS under eksponeringen for Norditropin (gennemsnitlig eksponeringsvarighed 4,1 år, område 0,3 til 9,5 år).
English: The most frequent adverse events were respiratory tract infections which are common in young children (14.6% of children) and scoliosis which is common in PWS (19.5% of children).
Danish: De hyppigste bivirkninger var luftvejsinfektioner, som er almindelige hos mindre børn (14,6 % af børnene), og skoliose, som er almindelig ved PWS (19,5 % af børnene).
English: The recommended dose is not the same as the one studied in the GHLiquid-1961 which was chosen at the discretion of the physician and was on average 0.03 mg/kg/day.
Danish: Den anbefalede dosis er ikke den samme som den, der blev undersøgt i GHLiquid-1961, hvor dosis blev valgt efter lægens skøn og i gennemsnit var 0,03 mg/kg/dag.
English: The quality of the data was also considered questionable given the fact that basic information such as baseline height was missing in 10% of patients.
Danish: Datakvaliteten blev desuden anset for tvivlsom på baggrund af, at grundlæggende oplysninger som højde ved baseline manglede for 10 % af patienternes vedkommende.
English: Thirty-three (33.26%) adverse events in 17 (41.5%) children were assessed as probably/possibly related to Norditropin treatment.
Danish: 33 (33,26 %) af bivirkningerne hos 17 (41,5 %) børn blev vurderet til at have sammenhæng eller muligvis at have sammenhæng med behandlingen med Norditropin.
English: In addition, accepting the same recommended dose as for other GH products was not considered appropriate as Norditropin has not shown comparable efficacy and those two products have different dose recommendations for other indications, i.e. Turner syndrome and chronic renal disease.
Danish: Endvidere blev det ikke anset for passende at godkende den samme anbefalede dosis som for de øvrige væksthormonprodukter, da Norditropin ikke har udvist sammenlignelig virkning, og da der for de pågældende to produkter anbefales en anden dosering til andre indikationer, dvs. Turners syndrom og kronisk nyresygdom.
English: The children were naïve to GH therapy at the time of first dose of Norditropin.
Danish: Børnene var naive for væksthormonbehandling, da de fik deres første dosis Norditropin.
English: Moreover, the quality of the data is questionable, as height measurements at baseline were missing in 10% of the subjects.
Danish: Desuden er datakvalitet tvivlsom, da højdemålinger ved baseline manglede for 10 % af personerne.
English: The secondary objectives were to evaluate in the same population the change in HSDS from start of treatment to last observation during Norditropin treatment (referenced to a PWS population), change in body composition (lean body mass and fat mass), height velocity (HV) and change in HV.
Danish: De sekundære formål var hos samme population at vurdere ændringen i HSDS fra behandlingens start til sidste observation under behandlingen med Norditropin (omtalt som en PWS-population), ændring i kropssammensætning (fedtfri kropsmasse og fedtmasse), væksthastighed (HV) og ændring i væksthastighed.
English: Furthermore, a wide range of doses has been used in the retrospective study (mean dose 0.03 mg/kg/day - up to 0.06 mg/kg/day).
Danish: Desuden blev der i den retrospektive undersøgelse anvendt meget forskellige doser (gennemsnitsdosis 0,03 mg/kg/dag - op til 0,06 mg/kg/dag).
English: The data from the study that were submitted with the application of Novo Nordisk to support the proposed indication were not considered sufficient (open-label, non-controlled and retrospective study) and of good quality (wide range of doses used, height measurements incomplete) by the objecting Member States.
Danish: De medlemsstater, der gjorde indsigelse, anså ikke data fra den undersøgelse, som Novo Nordisk havde indsendt sammen med ansøgningen til støtte for den foreslåede indikation, for at være tilstrækkelige (en åben, ikke kontrolleret, retrospektiv undersøgelse) eller af god kvalitet (stor spredning i den anvendte dosis, ufuldstændige højdemålinger).
English: Grounds for refusal Whereas
Danish: Begrundelse for afslaget Ud fra følgende betragtninger: