FrancophonIA/ELRC3.0 huggingface dataset:
English: Pelgraz can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Danish: Pelgraz udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
English: An overview of Pelgraz and why it is authorised in the EU
Danish: En oversigt over Pelgraz, og hvorfor det er godkendt i EU
English: Pelgraz is a ‘biosimilar medicine'.
Danish: Pelgraz er et "biosimilært lægemiddel".
English: Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Danish: Pelgraz gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
English: The reference medicine for Pelgraz is Neulasta.
Danish: Referencelægemidlet for Pelgraz er Neulasta.
English: Why is Pelgraz authorised in the EU?
Danish: Hvorfor blev Pelgraz godkendt i EU?
English: What are the risks associated with Pelgraz?
Danish: Hvilke risici er der forbundet med Pelgraz?
English: Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz.
Danish: Da Pelgraz er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke at blive gentaget for Pelgraz.
English: What is Pelgraz and what is it used for?
Danish: Hvad er Pelgraz, og hvad anvendes det til?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Pelgraz har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Pelgraz, pegfilgrastim, består af filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Pelgraz opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Danish: Pelgraz er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndrom (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: All these data were considered sufficient to conclude that Pelgraz will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Pelgraz vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Danish: Pelgraz gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber.
English: Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at indgivelse af Pelgraz giver samme niveau af det aktive stof i kroppen som indgivelse af Neulasta.
English: In addition, a study involving 589 patients who had chemotherapy after surgery for breast cancer showed that Pelgraz was as effective as Neulasta in reducing the duration of neutropenia.
Danish: Desuden viste et studie med 589 patienter, der var i behandling med kemoterapi efter brystkræftoperation, at Pelgraz var lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: For the full list of side effects and restrictions with Pelgraz, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pelgraz fremgår af indlægssedlen.
English: In Pelgraz, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Pelgraz er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: Laboratory studies comparing Pelgraz with Neulasta have shown that the active substance in Pelgraz is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: Laboratoriestudier, der sammenligner Pelgraz med Neulasta, har vist, at det aktive stof i Pelgraz svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: In addition, a study in breast cancer patients undergoing chemotherapy has shown that the effectiveness of Pelgraz is equivalent to that of Neulasta in reducing the duration of neutropenia.
Danish: Desuden har et studie med brystkræftpatienter i behandling med kemoterapi vist, at Pelgraz er lige så effektivt som Neulasta til at reducere varigheden af neutropeni.
English: How is Pelgraz used?
Danish: Hvordan anvendes Pelgraz?
English: It is available as a prefilled syringe containing a solution for injection under the skin.
Danish: Pelgraz fås som en fyldt pen med injektionsvæske til indsprøjtning under huden.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelgraz 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 Pelgraz.
English: How does Pelgraz work?
Danish: Hvordan virker Pelgraz?
English: What benefits of Pelgraz have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pelgraz?
English: Pelgraz is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Pelgraz er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: Pelgraz received a marketing authorisation valid throughout the EU on 21 September 2018.
Danish: Pelgraz (pegfilgrastim) EMA/518618/2018
English: This summary was last updated on 11.01.2007.
Danish: Dette sammendrag blev sidst ajourført den 11.01.2007.
English: All these effects disappear after a while without specific treatment.
Danish: Alle disse virkninger forsvinder efter et stykke tid uden behov for specifik behandling.
English: Its effect can be seen within about 2 weeks, and lasts for 5 months.
Danish: Dets virkning kan ses inden for ca. 2 uger og varer i 5 måneder.
English: Wash hands after administration.
Danish: Vask hænder efter håndtering af medicinen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ypozane to Virbac S.A. on 11.01.2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ypozane til Virbac S.A. den 11.01.2007.
English: Ypozane is given daily for 7 days.
Danish: Ypozane indgives én gang daglig i 7 dage.
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Danish: Dette veterinærlægemiddel er udviklet specielt til hunde og må ikke anvendes til mennesker.
English: Other information about Ypozane:
Danish: Andre oplysninger om Ypozane:
English: A clinical response to treatment (reduction of prostate volume) was seen within 14 days, which lasted for at least 5 months.
Danish: Der sås en klinisk respons på behandlingen (reduceret størrelse af prostata) inden for 14 dage, som varede i mindst 5 måneder.
English: The effectiveness of osaterone acetate was investigated in a large study undertaken in a number of veterinary practices across Europe.
Danish: Effektiviteten af osateronacetat blev undersøgt i en omfattende undersøgelse, der blev foretaget i en række dyrlægepraksiser rundt omkring i Europa.
English: The most common side effects are a transient increase in appetite, and changes in the behaviour of the dog (changes in activity levels, more sociable behaviour).
Danish: De mest almindelige bivirkninger er en forbigående appetitøgning og adfærdsændringer hos hunden (ændret aktivitetsniveau, mere social adfærd).
English: After this time, the dog should be re-examined by a veterinarian and treatment might be repeated.
Danish: Herefter skal hunden undersøges igen af en dyrlæge, hvorefter behandlingen muligvis skal gentages.
English: The medicine is available as 1.875 mg, 3.75 mg, 7.5 mg or 15 mg tablets, which can be used for dogs of different weights (small, medium sized, large or very large dogs).
Danish: Medicinen findes som tabletter med 1,875 mg, 3,75 mg, 7,5 mg eller 15 mg, som kan anvendes til hunde med forskellig vægt (små, mellemstore, store eller meget store hunde).
English: Ypozane has no adverse effects on semen quality.
Danish: Ypozane har ingen negativ virkning på sædkvalitet.
English: Ypozane should be used with caution in dogs which have had liver problems.
Danish: Ypozane skal anvendes med forsigtighed til hunde, som har haft leverproblemer.
English: The benefitrisk balance may be found in module 6 of this EPAR.
Danish: Benefit/risk-forholdet findes i modul 6 af denne EPAR.
English: The dogs received once a day for 7 days, one Ypozane tablet appropriate for their size to correspond to a daily dose of 0.250.5 mg osaterone acetate per kilogram bodyweight.
Danish: Hundene fik én gang om dagen i 7 dage én Ypozane-tablet, der var passende for deres vægt og svarende til en daglig dosis på 0,25-0,5 mg osateronacetat pr. kilo kropsvægt.
English: Dogs with enlarged prostates from various breeds, age groups and weights, were either treated with Ypozane or with another product, which is already authorised in the EU for this indication.
Danish: Hunde med forstørret prostata af forskellige racer og i forskellige alders- og vægtgrupper blev enten behandlet med Ypozane eller med et andet præparat, som allerede er godkendt i EU til denne indikation.
English: Ypozane are round, white tablets that contain osaterone acetate as the active substance.
Danish: Ypozane er runde, hvide tabletter, der indeholder osateronacetat som det aktive stof.
English: Some dogs might also show vomiting, diarrhoea or increased thirst, or might develop a “feminisation syndrome”.
Danish: Nogle hunde vil muligvis også have opkastning, diarré eller udvikle “feminiseringssyndrom”.
English: By inhibiting testosterone, Ypozane helps the prostate to shrink back to its normal size.
Danish: Ved at hæmme testosteron er Ypozane med til at få prostata til at vende tilbage til dens normale størrelse.
English: Osaterone acetate is a hormone that is chemically related to progesterone, and as such it has anti-androgen and progestagen activity.
Danish: Osateronacetat er et hormon, som er kemisk beslægtet med progesteron, og som sådan har det anti-androgen og progestagen aktivitet.
English: Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when handling the tablets.
Danish: Kvinder i den fødedygtige alder skal derfor undgå kontakt med tabletterne eller bære engangshandsker ved håndtering af disse.
English: In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions.
Danish: Blandt tævelaboratoriedyr fremkaldte osateronacetat alvorlige bivirkninger på forplantningsfunktionen.
English: The prostate is a gland that produces a fluid that is part of the semen.
Danish: Prostata er en kirtel, som producerer en væske, der udgør en del af sæden.
English: Treatment with Ypozane was effective in the treatment of benign prostatic hypertrophy.
Danish: Behandling med Ypozane var effektiv til behandling af benign prostatahypertrofi.
English: Data were provided on the pharmaceutical quality of the product, the tolerance of Ypozane in dogs and the safety of the tablets when handled by humans.
Danish: Der er forelagt oplysninger om produktets farmaceutiske kvalitet, om hvordan Ypozane tåles af hunde, og om sikkerheden, når mennesker kommer i berøring med tabletterne.
English: What is the risk associated with Ypozane?
Danish: Hvilken risiko er der forbundet med Ypozane?
English: Why has Ypozane been approved?
Danish: Hvorfor er Ypozane blevet godkendt?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ypozane exceed its risks for the treatment of benign prostatic hypertrophy (BPH) in male dogs and recommended that Ypozane be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at Ypozanes gavnlige virkninger er større end de mulige risici ved behandling af benign prostatahypertrofi (BPH) hos hanhunde, og anbefalede udstedelse af markedsføringstilladelse for Ypozane.
English: In male dogs, it blocks the transport of the male hormone testosterone into the prostate.
Danish: I hanhunde blokerer det transporten af det mandlige kønshormon, testosteron, ind i prostata.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den foreliggende dokumentation førte til, at man anbefalede at anvende veterinærlægemidlet som beskrevet nedenfor.
English: Ypozane is used in male dogs for the treatment of “benign prostatic hypertrophy”, which means an increase of the size of the prostate gland that is not related to cancer (benign).
Danish: Ypozane anvendes til behandling af hanhunde med “benign prostatahypertrofi”, som betyder en forstørrelse af prostata, som ikke er relateret til kræft (benign - godartet).
English: What is Ypozane?
Danish: Hvad er Ypozane?
English: When it is enlarged, it can lead to abdominal pain, constipation and difficulties in urinating in the dogs affected.
Danish: En forstørret prostata kan give mavesmerter, forstoppelse og vandladningsbesvær hos de påvirkede hunde.
English: This is when male dogs suddenly become attractive to other male dogs or the size of their mammary glands increases.
Danish: Sidstnævnte vil sige, at hanhunde pludselig bliver tiltrækkende for andre hanhunde eller får forstørrede brystvorter.
English: How has Ypozane been studied?
Danish: Hvordan er Ypozane blevet undersøgt?
English: What is Ypozane used for?
Danish: Hvad anvendes Ypozane til?
English: What benefit has Ypozane shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ypozane?
English: How does Ypozane work?
Danish: Hvordan virker Ypozane?
English: It is also planned to transform this working group into a standing working party.
Danish: Det planlægges ligeledes at omdanne denne arbejdsgruppe til en stående arbejdsgruppe.
English: He also holds an MBA.
Danish: Har desuden en MBA.
English: Typically this is done to benefit from price differentials.
Danish: Det sker typisk for at drage fordel af prisforskelle.
English: PSURs FUM and SO
Danish: PSUR FUM og SO
English: Part of the new legislation has already come into effect and been implemented.
Danish: En del af den nye lovgivning er allerede trådt i kraft og er blevet gennemført.
English: The situation, therefore, will be continuously monitored
Danish: Situationen vil derfor blive fulgt løbende
English: The implementation strategy concentrates on a number of projects with high European added value.
Danish: Gennemførelsesstrategien koncentrerer sig om en række projekter med stor europæisk merværdi.
English: To be revised and updated (jointly with Health Canada)
Danish: Revideres og opdateres (i fællesskab med Health Canada)
English: He has three daughters, the eldest of whom is affected by cystic fibrosis.
Danish: Har tre døtre, hvoraf den ældste lider af cystisk fibrose.
English: (draft budget)
Danish: (budgetforslag)
English: This list should be submitted by the Member States by 30 April 2005 and is expected to be rather extensive
Danish: Denne liste skal fremsendes til medlemsstaterne senest den 30. april 2005 og forventes at blive temmelig omfattende
English: Some deadlines were shortened in the existing approval process.
Danish: Visse frister i den eksisterende godkendelsesproces blev afkortet.
English: It will not only streamline and automate a number of related procedures but will also explore alternatives to physical meetings.
Danish: Det vil ikke alene effektivisere og automatisere en række beslægtede procedurer, men vil også udforske alternativer til fysiske møder.
English: He was also responsible for a laboratory unit.
Danish: Han var desuden ansvarlig for en laboratorieafdeling.
English: In addition, the new legislation aims to help small and medium-sized enterprises to access the centralised procedure.
Danish: Derudover tilstræber den nye lovgivning at bistå små og mellemstore virksomheder med at få adgang til den centraliserede procedure.
English: Continuous support to observers from candidate countries
Danish: Fortsat støtte til observatører fra kandidatlande
English: Eleven meetings will be held that will run for at least two full days.
Danish: Der vil blive afholdt elleve møder, der vil løbe over mindst to hele dage.
English: The committees are to be kept informed on scientific and technological development in this scientific area
Danish: Udvalgene skal holdes orienteret om den videnskabelige og teknologiske udvikling på dette videnskabelige område
English: The forecast number of SUSAR reports for 2005 is 8,000
Danish: Det skønnede antal SUSAR-indberetninger for 2005 er 8 000
English: Details of all planned guidance documents are included in Annex 3.
Danish: Samtlige planlagte vejledningsdokumenter er indeholdt i bilag 3.
English: The total in 2005 is expected to reach € 33,498,000
Danish: Det samlede beløb i 2005 forventes at komme op på 33 498 000 €
English: A large number of important telematics projects are carried out by the Agency concomitantly.
Danish: Et stort antal vigtige telematikprojekter er samtidigt ved at blive gennemført af agenturet.
English: That collaboration has already resulted in significant achievements over the past 10 years, and ongoing commitment from all partners will secure our position as one of the foremost regulatory systems in the world.
Danish: Dette samarbejde har allerede udmøntet sig i betydelige resultater over de seneste 10 år, og alle partnernes fortsatte engagement vil sikre vores position som et af de fremmeste kontrolsystemer i verden.
English: Member of the Pharmaceutical Society of Ireland.
Danish: Medlem af Pharmaceutical Society of Ireland.
English: For more information please refer to section 2.12.
Danish: For flere oplysninger henvises til afsnit 2.12 ovenfor.
English: New Member States will participate for the first time in the sampling part of the programme.
Danish: Nye medlemsstater vil deltage for første gang i programmets afprøvningsdel.
English: Improvement of general transparency and communication between all stakeholders
Danish: Forbedring af den generelle gennemsigtighed og kommunikation mellem alle interessenter
English: Visitors to the Agency
Danish: Besøgende i agenturet
English: An additional 51,800 ICSRs are expected from outside the EU.
Danish: Der forventes yderligere 51 800 ICSR fra lande uden for EU.
English: The Agency assists delegates with logistics and practical arrangements.
Danish: Agenturet bistår delegerede med logistik og praktiske arrangementer.
English: Censor Jurado de Cuentas and Member of the Registro Oficial de Auditores de Cuentas in Spain.
Danish: Censor Jurado de Cuentas og medlem af Registro Oficial de Auditores de Cuentas i Spanien.
English: The Agency will phase in the whole package of new activities and tasks over the course of 2005 and 2006.
Danish: Agenturet vil gradvist indføre hele pakken af nye aktiviteter og opgaver i løbet af 2005 og 2006.
English: This builds on a previous increase of 20 % relative to the number forecast for 2004.
Danish: Dette er baseret på en tidligere stigning på 20 % i forhold til det skønnede antal for 2004.
English: Establishment of effective working relations with the European Food Safety Authority
Danish: Etablering af effektive arbejdsrelationer med Den Europæiske Fødevaresikkerhedsautoritet
English: Revision, where necessary, of the Agency's management of minor variations, taking into account the first year's experience of the implementation of new Community legislation
Danish: Revision, hvor det er nødvendigt, af agenturets styring af mindre ændringer under hensyntagen til det første års erfaring med gennemførelsen af den nye fællesskabslovgivning
English: The actions fall within a number of areas, including:
Danish: Initiativerne falder inden for en række områder, herunder:
English: Emphasis is made on provision of information which is better adapted to its users.
Danish: Hovedvægten er lagt på tilvejebringelse af oplysninger, der er bedre tilpasset brugerne.
English: Corresponding strategies and policies will be prepared in 2005.
Danish: Der vil blive udarbejdet tilsvarende strategier og politikker i 2005.
English: Examples of areas where clarification is necessary include:
Danish: Til de områder, hvor en præcisering er nødvendig, hører bl.a.:
English: The EMEA publishes a European public assessment report (EPAR) once the Commission decision has been taken.
Danish: EMEA offentliggør en europæisk offentlig evalueringsrapport (EPAR) efter kommissionsafgørelsen.
English: 60 % increase in the reimbursement of meeting expenses to delegates, national authorities and suppliers
Danish: 60 % stigning i godtgørelsen af mødeudgifter til delegerede, nationale myndigheder og leverandører
English: The target for 2005 is to have a majority of Member State competent authorities and a significant number of pharmaceutical companies reporting through the system
Danish: Målet for 2005 er, at et flertal af medlemsstaternes kompetente myndigheder og et betydeligt antal lægemiddelvirksomheder indberetter gennem systemet
English: For this reason, the Administration unit maintains regular contacts with the above institutions and with the other European agencies.
Danish: Administrationsafdelingen holder i den henseende løbende kontakt med ovennævnte institutioner og med de øvrige europæiske agenturer.
English: Faster release of the summary of opinion after Commission decision through improved consultation with patients' organisations
Danish: Hurtigere frigivelse af resuméet af udtalelser efter Kommissionens afgørelse gennem forbedret høring af patientorganisationer
English: To be finalised following end of consultation, the revision and update of 3AQ10a
Danish: Afsluttes efter høring, revision og opdatering af 3AQ10a
English: To manage efficiently the cash resources of the Agency and maintain relationships with the Agency's banks
Danish: At styre agenturets kontantbeholdninger effektivt og opretholde forbindelserne med agenturets banker
English: In November 2005, the MRFG will be replaced by the coordination group established by the new legislation.
Danish: I november 2005 vil MRFG blive erstattet af den gennem den nye lovgivning nedsatte koordineringsgruppe.
English: Review and possible revision of the guideline.
Danish: Gennemgang og eventuel revision af retningslinjen.