FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/13/827/028 56 x 1 film-coated tablets EU/1/13/827/029 60 film-coated tablets
Danish: EU/1/13/827/028 56 x 1 filmovertrukne tabletter EU/1/13/827/029 60 filmovertrukne tabletter
English: EU/1/13/827/026 50 film-coated tablets
Danish: EU/1/13/827/026 50 filmovertrukne tabletter
English: EU/1/13/827/014 98 film-coated tablets
Danish: EU/1/13/827/014 98 filmovertrukne tabletter
English: EU/1/13/827/031 84 film-coated tablets
Danish: EU/1/13/827/031 84 filmovertrukne tabletter
English: EU/1/13/827/001 7 film-coated tablets
Danish: EU/1/13/827/001 7 filmovertrukne tabletter
English: EU/1/13/827/012 70 film-coated tablets
Danish: EU/1/13/827/012 70 filmovertrukne tabletter
English: EU/1/13/827/003 14 film-coated tablets
Danish: EU/1/13/827/003 14 filmovertrukne tabletter
English: EU/1/13/827/013 84 film-coated tablets
Danish: EU/1/13/827/013 84 filmovertrukne tabletter
English: PecFent received a marketing authorisation valid throughout the EU on 31 August 2010.
Danish: PecFent fik en markedsføringstilladelse med gyldighed i hele EU den 31. august 2010.
English: What is PecFent and what is it used for?
Danish: Hvad er PecFent, og hvad anvendes det til?
English: It is a well-known substance, which has been used to control pain for many years.
Danish: Det er et velkendt stof, der har været anvendt i mange år til at kontrollere smerter.
English: This means that it is similar to ‘reference medicines' containing the same active substance, but given in a different way.
Danish: Det betyder, at det svarer til en række "referencelægemidler", der indeholder samme aktive stof, men gives på en anden måde.
English: Further information on PecFent can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om PecFent findes på agenturets websted under: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The doses should be given as either one spray or two sprays of the same strength.
Danish: Doserne bør gives enten som én eller to spray af samme styrke.
English: The patient should be monitored carefully while the dose is increased.
Danish: Patienten bør overvåges omhyggeligt, mens dosis øges.
English: The average reduction in pain during the first 30 minutes after use was 6.6 points in patients receiving PecFent compared with 4.5 in those receiving placebo.
Danish: Den gennemsnitlige reduktion af smerter i løbet af de første 30 minutter efter brug var 6,6 point hos patienter, der fik PecFent, sammenholdt med 4,5 point blandt dem, der fik placebo.
English: PecFent is a ‘hybrid medicine'.
Danish: PecFent er et "hybridt lægemiddel".
English: Patients should be closely monitored for these side effects.
Danish: Patienterne bør overvåges nøje for disse bivirkninger.
English: Typical opioid side effects are to be expected with PecFent; often these will stop or become less intense with continued use of the medicine.
Danish: Typiske opioid-bivirkninger må forventes med PecFent; de vil ofte ophøre eller blive mindre intense ved fortsat brug af lægemidlet.
English: As for all medicines, data on the use of PecFent are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af PecFent løbende overvåget.
English: Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.
Danish: Da PecFent er et hybridt lægemiddel, fremlagde ansøgeren oplysninger om referencelægemidlerne i tillæg til resultaterne af sine egne studier.
English: Patients should not take more than four doses a day and should leave a gap of at least four hours between treating each episode of pain.
Danish: Patienterne bør ikke tage mere end fire doser om dagen, og der bør gå mindst fire timer mellem hver dosis.
English: What measures are being taken to ensure the safe and effective use of PecFent?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af PecFent?
English: An overview of PecFent and why it is authorised in the EU
Danish: En oversigt over PecFent, og hvorfor det er godkendt i EU
English: Why is PecFent authorised in the EU?
Danish: Hvorfor er PecFent godkendt i EU?
English: Other information about PecFent:
Danish: Andre oplysninger om PecFent
English: Side effects reported with PecFent are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for PecFent vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: The first trial dose should always be 100 micrograms (one spray into one nostril).
Danish: Startdosen bør altid være 100 mikrogram (én spray i ét næsebor).
English: The main measure of effectiveness was the change in the severity of pain measured by the patients ranking their pain on a scale from 0 to 10.
Danish: Det primære mål for virkning var ændringen i sværhedsgraden af smerter som bedømt af patienterne på en skala fra 0 til 10.
English: The doctor should keep in mind the potential for PecFent to be abused.
Danish: Lægen bør være opmærksom på, at PecFent kan misbruges.
English: The company that markets PecFent will provide educational materials in each EU Member State to make sure that patients, doctors and pharmacists are aware of how PecFent should be used, the risk of accidental exposure to fentanyl and how to dispose of the medicine.
Danish: Den virksomhed, der markedsfører PecFent, skal udarbejde informationsmateriale i hver EUmedlemsstat for at sikre, at patienter, læger og apotekspersonale er klar over, hvordan PecFent bør anvendes, hvad risikoen for utilsigtet eksponering for fentanyl er, og hvordan lægemidlet bør bortskaffes.
English: For more information about using PecFent, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af PecFent, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What are the risks associated with PecFent?
Danish: Hvilke risici er der forbundet med PecFent?
English: When a patient starts to take PecFent the doctor will need to work out the appropriate dose that will provide adequate pain relief with as few side effects as possible.
Danish: Når en patient starter med at tage PecFent, er lægen nødt til at beregne, hvilken dosis der giver tilstrækkelig smertelindring med så få bivirkninger som muligt.
English: PecFent is available as a nasal spray (100 and 400 micrograms per spray) and can only be obtained by ‘special' prescription.
Danish: PecFent fås som en næsespray (100 og 400 mikrogram pr. spray) og kan kun fås på en særlig recept.
English: The most serious of these side effects are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Danish: De alvorligste bivirkninger er respirationsdepression (hæmning af vejrtrækningen), kredsløbsdepression (langsom hjerterytme), for lavt blodtryk og shock (markant fald i blodtrykket).
English: In this study, patients reported that they were ‘satisfied' or ‘very satisfied' with PecFent treatment for around 90% of breakthrough pain episodes.
Danish: I dette studie rapporterede patienterne, at de var tilfredse eller meget tilfredse med PecFent-behandlingen i ca. 90 % af tilfældene af gennembrudssmerter.
English: While the reference medicines Effentora (buccal tablets) and Actiq (lozenges) are taken by mouth, PecFent is given as a spray into the nose.
Danish: Mens referencelægemidlerne Effentora (bukkaltabletter) og Actiq (sugetabletter) tages gennem munden, gives PecFent som en spray i næsen.
English: The active substance in PecFent, fentanyl, is an opioid.
Danish: Det aktive stof i PecFent, fentanyl, er et opioid.
English: PecFent contains the active substance fentanyl.
Danish: PecFent indeholder det aktive stof fentanyl.
English: In one main study, PecFent was shown to be more effective than placebo (a dummy treatment) at treating breakthrough cancer pain in 83 adults who were being treated with opioids.
Danish: I et hovedstudie blev det påvist, at PecFent er mere effektivt end placebo (ikke-aktivt stof) til at behandle gennembrudssmerter hos 83 voksne kræftpatienter, som blev behandlet med opioider.
English: PecFent must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Danish: PecFent bør ikke anvendes hos patienter, der ikke allerede tager opioider for at holde smerterne under kontrol, der har svær respirationsdepression (hæmning af vejrtrækningen) eller som har en svær obstruktiv lungesygdom (sygdom, der i alvorlig grad hæmmer vejrtrækningen).
English: Treatment with PecFent should be started by and remain under the supervision of a doctor who has experience in managing opioid treatment in cancer patients.
Danish: Behandling med PecFent bør iværksættes og gennemføres under overvågning af en læge, der har erfaring i opioidbehandling af kræftpatienter.
English: It must not be used to treat short-term pain other than breakthrough pain.
Danish: Det må ikke anvendes til behandling af kortvarige smerter, som ikke er gennembrudssmerter.
English: How is PecFent used?
Danish: Hvordan anvendes PecFent?
English: When the patient sprays PecFent into the nose, a dose of fentanyl is rapidly absorbed into the blood stream through the blood vessels in the nose.
Danish: Når patienten sprayer PecFent ind i næsen, optages fentanyl-dosen hurtigt i blodbanen gennem blodkarrene i næsen.
English: An additional study measured the ‘acceptability' of PecFent by the patients, rating how satisfied they were with PecFent, and how easy and convenient they found it to use.
Danish: Et andet studie målte patienternes tilfredshed med PecFent og i, hvor høj grad de fandt det let og smart at bruge.
English: The European Medicines Agency noted that there was a need for fast-acting pain medicines for breakthrough pain in patients with cancer.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at der var behov for et hurtigvirkende smertestillende middel mod gennembrudssmerter hos kræftpatienter.
English: Based on available data, the Agency concluded that PecFent's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved PecFent opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: PecFent is a medicine used to treat breakthrough pain in adult patients with cancer.
Danish: PecFent er et lægemiddel, der anvendes til behandling af gennembrudssmerter hos voksne patienter med kræft.
English: PecFent is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Danish: PecFent anvendes hos voksne patienter, der allerede bruger opioider såsom morfin og fentanyl for at kontrollere langvarig kræftsmerte.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Danish: Det betyder, at betingelserne for at få det udleveret er skrappere end sædvanligt, da lægemidlet kan misbruges og skabe afhængighed.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Danish: Når først fentanyl er i blodbanen, påvirker det receptorer i hjernen og rygmarven og har derigennem en smertestillende virkning.
English: What benefits of PecFent have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved PecFent?
English: For the full list of side effects reported with PecFent, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved PecFent fremgår af indlægssedlen.
English: How does PecFent work?
Danish: Hvordan virker PecFent?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of PecFent 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 PecFent.
English: What is Begedina?
Danish: Hvad er Begedina?
English: There were also deficiencies identified in the manufacturing process of the medicine.
Danish: Der blev også konstateret mangler i fremstillingsprocessen for lægemidlet.
English: On 4 July 2016, Adienne S.r.l.
Danish: Den 4. juli 2016 meddelte Adienne S.r.l.
English: In addition, the safety profile and the way the medicine is expected to work in the body had not been sufficiently characterised.
Danish: Desuden var lægemidlets sikkerhedsprofil og den måde, det forventes at virke i kroppen på, ikke blevet tilstrækkeligt karakteriseret.
English: In the studies, Begedina was not compared with any other treatment.
Danish: I undersøgelserne blev Begedina ikke sammenlignet med nogen anden behandling.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Begedina og har behov for mere information om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: Withdrawal of the marketing authorisation application for Begedina (begelomab)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Begedina (begelomab)
English: Begedina is a medicine that contains the active substance begelomab.
Danish: Begedina er et lægemiddel, der indeholder det aktive stof begelomab.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: EMA/579473/2016 EMEA/H/C/004144
Danish: Den 22. juli 2016 EMA/579466/2016 EMEA/H/C/004144
English: Withdrawal of the marketing authorisation application for Begedina (begelomab) EMA/579473/2016
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Begedina (begelomab) EMA/579466/2016
English: What was Begedina expected to be used for?
Danish: Hvad forventedes Begedina anvendt til?
English: Begedina was expected to be used for the treatment of acute graft-versus-host disease (a condition in which transplanted cells attack the patient's body) in adults who have had haematopoietic progenitor cell transplantation (transplant of cells that can develop into different types of blood cells) from a donor.
Danish: Begedina forventedes anvendt til akut transplantat-mod-vært-sygdom (en sygdom, hvor transplanterede celler angriber patientens krop) hos voksne, som har fået transplanteret bloddannende (hæmatopoietiske) stamceller (celler, der kan udvikle sig til forskellige typer af blodceller) fra en donor.
English: By attaching to CD26, this medicine is expected to reduce the rate at which the T cells multiply.
Danish: Ved at bindes til CD26 forventes dette lægemiddel at nedsætte T-cellernes formering.
English: This is expected to reduce the number and
Danish: Dette forventes at nedsætte antallet og aktiviteten af de T-celler fra
English: These are a type of white blood cells that play a role in graft-versus-host disease.
Danish: Disse er en type hvide blodlegemer, der spiller en rolle ved transplantat-mod-vært-sygdom.
English: The CHMP considered that the data provided were insufficient to demonstrate a beneficial effect of Begedina.
Danish: CHMP fandt, at de forelagte data var utilstrækkelige til at påvise en gavnlig virkning af Begedina.
English: The company presented the results of two studies with Begedina involving a total of 29 adults with acute graft-versus-host disease that did not respond to steroid treatment.
Danish: Virksomheden fremlagde resultaterne af to undersøgelser med Begedina med deltagelse af i alt 29 voksne med akut transplantat-mod-vært-sygdom, der ikke reagerede på behandling med steroider.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.
Danish: officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Begedina til behandling af transplantat-mod-vært-sygdom.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Begedina?
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it acknowledges the need to obtain additional data from a confirmatory study.
Danish: I brevet, hvor EMA underrettedes om tilbagetrækningen af ansøgningen, vedgik virksomheden, at der behøves supplerende data fra en bekræftende undersøgelse.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Danish: Det skulle have kunnet fås som et koncentrat, der blandes til en opløsning til infusion (drop) i en vene.
English: How was Begedina expected to work?
Danish: Hvordan forventedes Begedina at virke?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Begedina.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Begedina.
English: Begedina was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 November 2010 for treatment of graft-versus-host disease.
Danish: Begedina blev den 26. november 2010 udpeget som "lægemiddel til sjældne sygdomme" til behandling af transplantat-mod-vært-sygdom.
English: Based on the review of the available data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Begedina could not have been approved for the treatment of acute graft-versus-host disease that did not respond to steroid treatment.
Danish: På baggrund af gennemgangen af de foreliggende data på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Begedina ikke kunne være blevet godkendt til behandling af akut transplantat-mod-vært-sygdom, der ikke reagerede på behandling med steroider.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Begedina.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at dokumentere ansøgningen om Begedina.
English: activity of T cells from the transplant that attack the patient's organs, thereby helping to control graftversus-host disease.
Danish: transplantatet, som angriber patientens organer, og derved at kontrollere transplantat-mod-værtsygdommen.
English: The medicine was for use in patients whose disease did not respond to treatment with steroids.
Danish: Lægemidlet skulle anvendes hos patienter, hos hvem steroider ikke virkede på sygdommen.
English: The active substance in Begedina, begelomab, is a monoclonal antibody (a type of protein) that has been designed to attach itself to a receptor called CD26, which is present on T cells.
Danish: Det aktive stof i Begedina, begelomab, er et protein af typen monoklonalt antistof.
English: 17 December 2012
Danish: Den 17. december 2012
English: The referral procedure started on 12 October 2011.
Danish: Henvisningsproceduren blev indledt den 12. oktober 2011.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: 1 Article 35 of Directive 2001/82/EC, as amended
Danish: 1 Artikel 35 i direktiv 2001/82/EF, som ændret.
English: The final opinion was converted into a Decision by the European Commission on 17 December 2012.
Danish: Den endelige udtalelse blev den 17. december 2012 omarbejdet til en beslutning af EuropaKommissionen.
English: The pharmaceutical form is an oral solution administered via the drinking water.
Danish: Lægemiddelformen er en oral opløsning, der administreres gennem drikkevandet.
English: International non-proprietary name (inn): enrofloxacin Background information
Danish: Internationalt fællesnavn (INN): enrofloxacin Baggrund
English: Supplementary information was provided in writing by an applicant and marketing authorisation holders on 16 January 2012.
Danish: En ansøger og markedsføringstilladelsesindehaverne fremsendte skriftligt yderligere oplysninger den 16. januar 2012.
English: The dosage is 10 mg enrofloxacin per kg bodyweight during 5 days.
Danish: Doseringen er 10 mg enrofloxacin pr. kg kropsvægt i 5 dage.
English: The Committee appointed Dr M. Holzhauser-Alberti as rapporteur and Dr C. Muñoz Madero as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis dr. M. Holzhauser-Alberti og dr. C. Muñoz Madero.
English: On 14 May 2012, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine.
Danish: Den 14. maj 2012 anmodede Europa-Kommissionen CVMP om fornyet overvejelse af sin udtalelse, hovedsagelig med henblik på præcisering af visse aspekter vedrørende antimikrobiel resistens og hensigtsmæssig anvendelse af antimikrobielle stoffer i veterinærlægemidler.
English: HIPRALONA ENRO-S and its generics are veterinary medicinal products which contain enrofloxacin as active substance, and are indicated in rabbits for the treatment of respiratory infections caused by Pasteurella multocida.
Danish: HIPRALONA ENRO-S og de tilsvarende generiske produkter er veterinærlægemidler, der indeholder enrofloxacin som aktivt indholdsstof og er indiceret til luftvejsinfektioner hos kaniner forårsaget af Pasteurella multocida.
English: Based on the evaluation of the available data, on 11 April 2012, the CVMP adopted by majority an opinion recommending the maintenance of the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics in accordance with the previously approved product information.
Danish: Efter at have vurderet de foreliggende data vedtog CVMP den 11. april 2012 ved en flertalsafgørelse en udtalelse, der anbefaler opretholdelse af markedsføringstilladelserne for veterinærlægemidlet HIPRALONA ENRO-S og de tilsvarende generiske produkter i overensstemmelse med de tidligere godkendte produktoplysninger.
English: On 13 September 2012, the CVMP adopted by majority a revised opinion confirming the recommendation, included in its opinion of 11 April 2012, that the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics should be maintained in accordance with the previously approved product information.
Danish: Den 13. september 2012 vedtog CVMP ved en flertalsafgørelse en revideret udtalelse, der bekræfter anbefalingen i udvalgets udtalelse af 11. april 2012 om, at markedsføringstilladelserne for veterinærlægemidlet HIPRALONA ENRO-S og de tilsvarende generiske produkter bør opretholdes i overensstemmelse med de tidligere godkendte produktoplysninger.
English: On 30 September 2011, France initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits, due to concerns that the use of the products in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Danish: Den 30. september 2011 indledte Frankrig en henvisning i henhold til artikel 35 i Rådets direktiv 2001/82/EF, som ændret, for veterinærlægemidlet HIPRALONA ENRO-S og de tilsvarende generiske produkter, der er indiceret til anvendelse hos kaniner.