FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Rekovelle, follitropin delta, is a copy of the natural hormone called folliclestimulating hormone (FSH) which plays a key role in fertility in women by stimulating the production of eggs in the ovaries.
Danish: Det aktive stof i Rekovelle, follitropin delta, er en kopi af det såkaldte follikelstimulerende hormon (FSH), et naturligt hormon, der spiller en afgørende rolle for kvinders frugtbarhed, idet det stimulerer produktionen af æg i æggestokkene.
English: How is Rekovelle used?
Danish: Hvordan anvendes Rekovelle?
English: Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in one study involving 1,326 women who were undergoing controlled ovarian stimulation for IVF or ICSI.
Danish: Rekovelle er blevet sammenlignet med en anden fertilitetsmedicin, GONAL-f (follitropin alfa), i en undersøgelse med 1 326 kvinder, der fik kontrolleret æggestokstimulerende behandling med henblik på reagensglasbefrugtning (IVF) eller mikroinsemination (ICSI).
English: What benefits of Rekovelle have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Rekovelle?
English: It is used to stimulate the ovaries to produce several eggs at the time, which can then be collected and fertilised in the laboratory.
Danish: Det gives for at stimulere æggestokkene til at producere flere æg ad gangen, der så kan opsamles og befrugtes i laboratoriet.
English: Rekovelle is available as a solution for injection, contained in a cartridge to be used with Rekovelle injection pen.
Danish: Rekovelle fås som injektionsvæske i en cylinderampul, der skal anvendes sammen med Rekovelleinjektionspennen.
English: Rekovelle must not be used in women with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Danish: Rekovelle må ikke gives til kvinder, der har en tumor i hypofysen eller hypothalamus, eller som har brystkræft, livmoderkræft eller æggestokkræft.
English: Rekovelle must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian syndrome, or when there is unexplained bleeding from the vagina.
Danish: Rekovelle må ikke anvendes, hvis kvinden har en forstørret æggestok eller en cyste, der ikke skyldes såkaldt polycystisk ovariesyndrom (cyster på æggestokkene), eller hvis hun har uforklaret blødning fra skeden.
English: For practical information about using Rekovelle, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Rekovelle, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Rekovelle, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Rekovelle fremgår af indlægssedlen.
English: Giving extra stimulation with Rekovelle helps increase the number of eggs produced in the ovaries, which means that more eggs can then be collected and fertilised in the laboratory.
Danish: Ved at give ekstra stimulation med Rekovelle øges antallet af æg, der produceres i æggestokkene, så der kan opsamles flere æg, som kan befrugtes i laboratoriet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekovelle 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 Rekovelle.
English: The CHMP considered that Rekovelle was effective in obtaining several eggs at the same time following stimulation in women undergoing fertility treatment.
Danish: CHMP vurderer, at Rekovelle er effektivt til at stimulere æggestokkene til at producere flere æg ad gangen hos kvinder, der er i fertilitetsbehandling.
English: Rekovelle is a medicine given to women who are having fertility treatments such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Danish: Rekovelle er et lægemiddel, som gives til kvinder, der er i fertilitetsbehandling som f.eks. reagensglasbefrugtning (IVF) eller mikroinsemination (ICSI).
English: Rekovelle is given by injection under the skin once a day for several consecutive days during the woman's menstrual cycle starting on day 2 or 3 of the cycle and is continued until sufficient eggs have developed.
Danish: Rekovelle gives som en injektion under huden én gang dagligt flere dage i træk i løbet af kvindens menstruationscyklus.
English: OHSS is when a woman's ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain.
Danish: Det kan give symptomer som f.eks. opkastning, diarré og smerter.
English: How does Rekovelle work?
Danish: Hvordan virker Rekovelle?
English: Tekinex was not compared directly with any other treatment.
Danish: Tekinex blev ikke sammenlignet direkte med nogen anden behandling.
English: What is Tekinex?
Danish: Hvad er Tekinex?
English: The effects of Tekinex were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Tekinex blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The study looked at how the patients responded to treatment based on results of blood tests taken to measure how active the cancer was.
Danish: I undersøgelsen så man på, hvordan patienterne reagerede på behandling baseret på resultaterne af blodprøver, der blev taget for at måle, hvor aktiv kræften var.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tekinex can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Tekinex findes på EMA's websted ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste over spørgsmål.
English: There was also insufficient follow-up of the patients following treatment and the Committee was doubtful about the medicine being safe enough to be self-administered by patients as intended by the company.
Danish: Der var ligeledes utilstrækkelig opfølgning af patienterne efter behandlingen, og udvalget var i tvivl om, hvorvidt lægemidlet er sikkert nok til, at patienterne selv kan tage det, sådan som det var virksomhedens mening.
English: The CHMP also had concerns about the doses used in the study and the criteria used for measuring the medicine's effectiveness.
Danish: CHMP havde ligeledes betænkeligheder med hensyn til de doser, der blev anvendt i undersøgelsen, og de kriterier, der blev anvendt til at måle lægemidlets virkning.
English: Because the number of patients with CML is low, the disease is considered ‘rare', and Tekinex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 September 2004.
Danish: Da antallet af patienter, der lider af CML, er lavt, betragtes sygdommen som "sjælden", og Tekinex blev udpeget som "lægemiddel til sjældne sygdomme" den 2. september 2004.
English: The company informed the CHMP that clinical trials with Tekinex will continue.
Danish: Virksomheden har informeret CHMP om, at de igangværende kliniske undersøgelser med Tekinex vil fortsætte.
English: What was Tekinex expected to be used for?
Danish: Hvad forventedes Tekinex anvendt til?
English: Tekinex is a medicine that contains the active substance omacetaxine mepesuccinate.
Danish: Tekinex er et lægemiddel, der indeholder det aktive stof omacetaxinmepesuccinat.
English: Finally, following an inspection of the study sites, the Committee noted that there were some inconsistencies in the application that could have affected the reliability of the study results.
Danish: Endelig bemærkede udvalget, at der efter en inspektion af undersøgelsesklinikkerne var en vis inkonsekvens i anvendelsen, som kunne have påvirket undersøgelsesresultaternes pålidelighed.
English: The CHMP was of the view that the medicine's benefits were uncertain.
Danish: CHMP var af den opfattelse, at der var usikkerhed omkring lægemidlets fordele.
English: How is Tekinex expected to work?
Danish: Hvordan forventes Tekinex at virke?
English: The active substance in Tekinex, omacetaxine, is an inhibitor of protein synthesis.
Danish: Det aktive stof i Tekinex, omacetaxin, er en proteinsyntesehæmmer.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Tekinex could not have been approved.
Danish: På baggrund af dataenes gennemgang havde CHMP nogle betænkeligheder på det tidspunkt, hvor ansøgningen blev trukket tilbage, og CHMP var af den foreløbige opfattelse, at Tekinex ikke kunne have været godkendt.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Tekinex did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Tekinex ikke opvejer risiciene.
English: The way it works is unclear, but it is thought to disrupt the production of the Bcr-Abl tyrosine kinase enzyme.
Danish: Det er uklart, hvordan det virker, men man mener, at det standser produktionen af Bcr-Abl-tyrosinkinaseenzymet.
English: The company presented results from a main study involving 66 patients with Philadelphia-positive CML and the T315I mutation, whose previous treatment with imatinib had failed.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse, der omfattede 66 patienter med Philadelphia-positiv CML og T315I-mutation, hvis tidligere behandling med imatinib var slået fejl.
English: Tekinex was therefore expected to work in Ph+ patients with the T315I mutation.
Danish: Tekinex forventedes således at virke hos Ph+-patienter med T315I-mutationen.
English: On 11 January 2011, ChemGenex Europe SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tekinex intended to be used to treat patients with Philadelphia chromosome-positive chronic myeloid leukaemia who have the ‘Bcr-Abl T315I kinase domain' mutation and whose previous treatment with imatinib had failed.
Danish: Den 11. januar 2011 meddelte ChemGenex Europe SAS officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Tekinex beregnet til behandling af patienter med Philadelphia-kromosompositiv kronisk myeloid leukæmi, som har Bcr-Abl T315I-kinasemutationen, og hvis tidligere behandling med imatinib var slået fejl.
English: Other medicines known as tyrosine kinase inhibitors, including imatinib, act in CML by attaching directly to the Bcr-Abl tyrosine kinase enzyme.
Danish: Andre lægemidler, der er kendt som tyrosinkinasehæmmere, herunder imatinib, virker ved CML ved at binde sig direkte til Bcr-Abl-tyrosinkinaseenzymet.
English: It was to be available as a powder to be made up into a solution for injection.
Danish: Det var meningen, at det skulle kunne fås som pulver til injektionsvæske, opløsning.
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
Danish: Ph+ betyder, at nogle af patientens gener har flyttet rundt på sig selv, så de danner et særligt kromosom, der kaldes Philadelphia-kromosomet, som producerer et enzym, Bcr-Abl-kinase, der fører til udviklingen af leukæmi.
English: It was to be used in patients whose previous treatment with imatinib (another anticancer medicine) had failed, possibly due to a mutation in the gene for the Bcr-Abl kinase called the ‘T315I mutation'.
Danish: Det var meningen, at det skulle anvendes hos patienter, hvis tidligere behandling med imatinib (et andet lægemiddel mod kræft) var slået fejl, muligvis på grund af en mutation i genet for Bcr-Ablkinase, som kaldes T315I-mutationen.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Tekinex eller i programmer for anvendelse af Tekinex med særlig udleveringstilladelse?
English: Tekinex was expected to be used to treat adults with ‘Philadelphia chromosome positive' (Ph+) chronic myeloid leukaemia (CML, a cancer of a type of white blood cells called granulocytes).
Danish: Tekinex forventedes anvendt til behandling af voksne med Philadelphia-kromosompositiv (Ph+) kronisk myeloid leukæmi (CML, som er kræft i en type hvide blodlegemer, der kaldes granulocytter).
English: The application was withdrawn at ‘day 120'.
Danish: Ansøgningsproceduren var ved dag 120, da virksomheden trak sin ansøgning tilbage.
English: It is derived from harringtonine, a substance extracted from a Chinese evergreen.
Danish: Det stammer fra harringtonin, som er et stof, der udvindes af aglaonema-planten.
English: The T315I mutation changes certain properties of the enzyme, making it harder for these medicines to attach to it. Because omacetaxine does not act in this way, its action is not affected by the T315I mutation.
Danish: T315I-mutationen ændrer visse af enzymets egenskaber og gør det sværere for disse lægemidler at binde sig til det.
English: Member state/EEA
Danish: Medlemsstat/ EØS
English: Applicant/ Marketing Authorisation Holder
Danish: Ansøger/ Indehaver af markedsføringstilladelsen
English: It was noted that some parts of the data presented were identical but were submitted by different Applicants/Marketing Authorisation Holders.
Danish: Det blev bemærket, at visse dele af de fremlagte data var identiske, men at de var indsendt af forskellige ansøgere/indehavere af markedsføringstilladelser.
English: The procedure involved 47 veterinary medicinal products authorised or pending authorisation in different Member States of the European Union (see Annex I).
Danish: Proceduren omfattede 47 veterinærlægemidler, som er godkendt eller afventer godkendelse i forskellige medlemsstater i EU (se bilag I).
English: 831 02 Bratislava SLOVAK REPUBLIC
Danish: 831 02 Bratislava DEN SLOVAKISKE REPUBLIK
English: Discussion of data available
Danish: Diskussion af foreliggende data
English: This group of antibiotics has a polypeptide structure, with mainly bactericide activity and a medium antibacterial spectrum, which covers gram-negative microorganisms only.
Danish: Denne gruppe antibiotika har en polypeptidstruktur med hovedsageligt baktericid aktivitet og et middel antibakterielt spektrum, som kun dækker gramnegative mikroorganismer.
English: For some of the products concerned a treatment period of 5 to 7 days was recommended which was considered too long with respect to the aim of achieving an optimal balance between bacteriological cure rate and risk for resistance development.
Danish: For nogle af de pågældende produkter anbefaledes en behandlingsperiode på 5-7 dage, som blev vurderet for lang med hensyn til formålet om at opnå en optimal balance mellem bakteriologisk helbredelsesrate og risikoen for udvikling af resistens.
English: Carabela La Niña nº 12 5ª planta 08017 Barcelona SPAIN
Danish: Carabela La Niña nº 12 5ª planta 08017 Barcelona SPANIEN
English: 1 Commission Regulation (EC) NO 1177/2006 of 1 August 2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of Salmonella in poultry (OJ L 212, 2.8.2006, p.3).http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:212:0003:0005:EN:PDF
Danish: 1 Kommissionens Forordning (EF) nr. 1177/2006 af 1. august 2006 om gennemførelse af Europa-Parlamentets og Rådets forordning (EF) nr. 2160/2003 for så vidt angår krav vedrørende anvendelse af særlige bekæmpelsesmetoder som led i de nationale programmer for bekæmpelse af salmonella hos fjerkræ (EUT L 212 af 2.8.2006, s. 3).
English: This dose was the recommended dose for the majority of the products included in this referral and has thus been in clinical use for many years.
Danish: Denne dosis var den anbefalede dosis for de fleste produkter i denne indbringelsesprocedure og har dermed været anvendt klinisk i mange år.
English: • the CVMP considered the overall submitted data and the general knowledge on the substance resulting from its well-established used in veterinary medicines for over 20 years.
Danish: • CVMP vurderede de generelle indsendte data og den generelle viden om stoffet, som er indsamlet via den veldokumenterede anvendelse i veterinærlægemidler i over 20 år.
English: Laboratoires Biové 3 rue de Lorraine 62510 Arques FRANCE
Danish: Laboratoires Biové 3 rue de Lorraine 62510 Arques FRANKRIG
English: Twice daily for five consecutive days (via drinking water or direct oral administration)
Danish: 2 gange dagligt i 5 på hinanden følgende dage (i drikkevand eller direkte oral administration)
English: INN Strength Pharmaceutical form
Danish: Styrke Lægemiddelform
English: Ceva Saúde Animal - Produtos Farmacêuticos e Farmacológicos, Lda Rua Doutor António Loureiro Borges, 9/9A - 9°A Miraflores
Danish: Farmacêuticos e Farmacológicos, Lda Rua Doutor António Loureiro Borges, 9/9A - 9°A Miraflores
English: With regard to established withdrawal periods they ranged in the Member States from 1 to 9 days.
Danish: De etablerede tilbageholdelsestider i medlemsstaterne lå på 1-9 dage.
English: For 3-5 days
Danish: I 3-5 dage
English: As regards to antimicrobial resistance against colistin it should be noted that firm conclusions regarding antimicrobial resistance could not be reached in the absence of consumption data.
Danish: Med hensyn til antimikrobiel resistens mod colistin skal det bemærkes, at der ikke kunne drages sikre konklusioner vedrørende antimikrobiel resistens, da der ikke forelå forbrugsdata.
English: Colistin sulfate is a polypeptide antibiotic belonging to the polymyxins group of antibiotics.
Danish: Colistinsulfat er et polypeptidantibiotikum tilhørende gruppen af polymyxinantibiotika.
English: The submitted data by the Applicants/Marketing Authorisation Holders showed that the concerned veterinary medicinal products are authorised or pending authorisations via different marketing authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases (full and generic).
Danish: De data, som er indsendt af ansøgerne/indehaverne af markedsføringstilladelserne viste, at de pågældende veterinærlægemidler er godkendt eller afventer godkendelse via forskellige godkendelsesprocedurer (procedurer for gensidig anerkendelse eller nationale procedurer) og på forskellige retlige grundlag (fuldt og generisk).
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER FOR DE VETERINÆRMEDICINSKE PRODUKTER, DYREARTER, INDGIVELSESVEJ, TILBAGEHOLDELSESTID, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: With drinking water or milk powder.
Danish: Med drikkevand eller mælkepulver.
English: There was no documented evidence indicating an increase in the development of resistance relevant to human or animal health.
Danish: Der var ingen dokumentation, som viste en stigning i udviklingen af resistens, som er relevant for dyrs og menneskers sundhed.
English: The data submitted to the Committee for evaluation was of poor quality and in some cases lacking to substantiate the claims, doses, duration of treatment or withdrawal periods.
Danish: som blev indsendt til CVMP, var af dårlig kvalitet og i visse tilfælde mangelfulde i forhold til at underbygge påstande, doser, behandlingsvarighed eller tilbageholdelsestider.
English: The only area of potential risks identified was the risk of lack of efficacy in case of invasive strains and the possibility of interference with Salmonella control programs.
Danish: Den eneste potentielle risiko, som blev identificeret, var risikoen for manglende effekt i tilfælde af invasive stammer og muligheden for interferens med Salmonella-bekæmpelsesprogrammer.
English: The data packages submitted consist of bibliographic data, available in the public domain, and proprietary data.
Danish: De indsendte datapakker består af bibliografiske data, som er offentligt tilgængelige, samt data, der tilhører virksomhederne og ikke er offentligt tilgængelige.
English: 3 - 5 days in drinking water, milk or direct administration
Danish: 3-5 dage i drikkevand, mælk eller direkte
English: Two products had a recommended duration of treatment of 3-4 consecutive days.
Danish: To produkter havde en anbefalet behandlingsvarighed på 3-4 på hinanden følgende dage.
English: 1 day
Danish: 1 dag
English: Zone Industrielle des Touches 200, avenue de Mayenne
Danish: 200, avenue de Mayenne
English: CEVA SANTE ANIMALE ROMANIA SRL
Danish: Rumænien CEVA SANTE ANIMALE ROMANIA SRL
English: For oral administration, usually via drinking water.
Danish: Til oral administration, sædvanligvis i drikkevandet.
English: However, as colistin has been approved for decades and resistance has remained low to date, in CVMP's view there was sufficient information available to conclude that resistance was not likely to be an emerging issue.
Danish: Da colistin har været godkendt i årtier, og resistensen til dato har holdt sig på et lavt niveau, er der efter CVMP's mening tilstrækkelige oplysninger til at konkludere, at resistens sandsynligvis ikke vil vise sig at blive et problem.
English: The extensive MIC data presented by the Applicants/Marketing Authorisation Holders covering the period during which colistin sulfate has been in clinical use indicates quite clearly that resistance development was not an issue of concern for this substance.
Danish: De omfattende MIC-data fra ansøgerne/indehaverne af markedsføringstilladelserne for den periode, hvor colistinsulfat har været anvendt klinisk, viser ret tydeligt, at udvikling af resistens ikke var et problem for dette stof.
English: Due to the poor absorption in the gut colistin would only be effective against noninvasive Salmonella.
Danish: Colistin vil på grund af den dårlige absorption i tarmen kun være effektivt mod non-invasiv Salmonella.
English: For some of the products concerned the recommended treatment interval was 3 to 5 days.
Danish: For nogle af de berørte produkter var det anbefalede behandlingsinterval 3-5 dage.
English: Pigs: 5 days Poultry: 3 days Eggs: do not use in animals from which eggs are produced for human consumption
Danish: Svin: 5 dage Fjerkræ: 3 dage Æg: Må ikke anvendes til dyr, hvis æg er bestemt til menneskeføde
English: 7100 Vejle
Danish: 7100 Vejle DANMARK
English: The duration of treatment currently recommended in the products authorised for calves and lambs was mainly 3 days.
Danish: Den nuværende anbefalede behandlingsvarighed for produkter godkendt til kalve og lam var sædvanligvis 3 dage.
English: In the submitted Periodic Safety Update Reports neither lack of efficacy nor emerging resistance development has been reported for the approved indications in any of the approved target species;
Danish: I de indsendte periodiske, opdaterede sikkerhedsindberetninger er der ikke rapporteret om manglende effekt eller udvikling af resistens for de godkendte indikationer hos nogen af de godkendte arter
English: The presented clinical data for treatment of salmonelosis in chickens was not conclusive and the appropriateness of using this substance for treating Salmonella infections could be questioned.
Danish: De forelagte kliniske data for behandling af salmonelose hos kyllinger var ikke fyldestgørende, og der kan sættes spørgsmålstegn ved, om dette stof er egnet til behandling af Salmonella-infektioner.