FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the supporting information from the scientific literature was weak and did not demonstrate a consistent clinical benefit of Sovrima for this disease.
Danish: Desuden var dokumentationen fra faglitteraturen svag, og den viste ikke nogen vedvarende klinisk effekt af Sovrima mod denne sygdom.
English: In addition, the CHMP was concerned that the information provided by the company did not show that Sovrima was more effective in children than in the wider group of patients initially proposed.
Danish: Derudover fandt CHMP grund til betænkelighed ved, at de oplysninger, som virksomheden havde fremlagt, ikke viste, at Sovrima var mere effektivt til børn end til den bredere patientgruppe, som oprindeligt var foreslået.
English: How is Sovrima expected to work?
Danish: Hvordan forventes Sovrima at virke?
English: Sovrima was expected to be used to treat Friedreich's ataxia.
Danish: Sovrima forventedes anvendt til behandling af Friedreichs ataksi.
English: Sovrima was designated as an orphan medicinal product on 8 March 2004 for Friedreich's ataxia.
Danish: Sovrima blev udpeget som lægemiddel til sjældne sygdomme den 8. marts 2004 til behandling af Friedreichs ataksi.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Sovrima?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Sovrima eller i programmer for anvendelse af Sovrima med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Sovrima.
English: The company also informed the CHMP that there are no consequences for the named patient programmes or compassionate use programmes with Sovrima.
Danish: Virksomheden har ligeledes informeret CHMP om, at afslaget ikke får konsekvenser for navngivne patientprogrammer eller programmer for anvendelse med særlig udleveringstilladelse med Sovrima.
English: Hence, the CHMP recommended that Sovrima be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Sovrima.
English: If protection against Rabies is required:
Danish: Hvis der ønskes beskyttelse mod rabies:
English: ATC vet code: QI07AI02.
Danish: ATCvet-kode: QI07AI02.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 07/05/2014.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/164/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/164/001
English: * Tissue culture infectious dose 50%.
Danish: * Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %).
English: ** Antibody micro agglutination-lytic reaction.
Danish: ** Antistof mikroagglutinationsreaktion - lytisk reaktion (antibody micro agglutination-lytic reaction).
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til canidae - levende virusvacciner og inaktiverede bakterievacciner.
English: EXP {month/year} Once reconstituted, use immediately.
Danish: EXP {måneder/år} Efter rekonstituering, anvendes straks.
English: Date of last renewal: 08/04/2019.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 08/04/2019.
English: In case of need, dogs younger than 8 weeks can be vaccinated as safety of Versican Plus DHPPi/L4R has been demonstrated in 6 weeks old dogs.
Danish: Ved behov kan hunde under 8-uger vaccineres, da sikkerheden af Versican Plus DHPPi/L4R er påvist hos hunde i 6-ugers alderen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En dosis à 1 ml indeholder:
English: However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Danish: I feltstudier viste 10% af seronegative hunde dog ikke serokonvertion (> 0,1 IE/ml) 3-4 uger efter en enkelt basisvaccination mod rabies.
English: In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements ( antibody titres ≥ 0.5 IU/ml).
Danish: I tilfælde af rejser til risikoområder eller rejser uden for EU, kan dyrlægen give en ekstra rabiesvaccination efter 12 ugers alderen for at sikre, at de vaccinerede hunde har et antistoftiter på ≥ 0,5 IE/ml som generelt anses for tilstrækkelig beskyttelse, og at det opfylder testkrav for rejser (antistoftitre på ≥ 0,5 IE/ml).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: A single dose of Versican Plus DHPPi/L4 should be given every 3 years.
Danish: En enkeltdosis af Versican Plus DHPPi/L4 bør indgives hvert 3. år.
English: Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
Danish: Solvens (inaktiveret): L. interrogans serovar Icterohaemorrhagiae
English: Second dose: Versican Plus DHPPi/L4R 3-4 weeks later but not before 12 weeks of age.
Danish: 2. dosis: Versican Plus DHPPi/L4R 3-4 uger senere men ikke tidligere end 12-ugers alderen.
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundesygevirus, hundeparvovirus, hundeadenovirus type 1 og 2, hundeparainfluenzavirus, Leptospira interrogans serogruppe Australis serovar Bratislava, Leptospira interrogans serogruppe Canicola servar Canicola, Leptospira kirschneri serogruppe Grippotyphosa serovar Grippotyphosa og Leptospira interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae.
English: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus.
Danish: Mindst 3 år efter basisvaccination for for hundesygevirus, hundeadenovirus type 1, hundeadenovirus type 2 og hundeparvovirus.
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated):
Danish: Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15 103,1 TCID50* 105,1 TCID50 Suspension (inaktiveret):
English: CLINICAL PARTICULARS 4.1 Target species Dogs
Danish: KLINISKE OPLYSNINGER 4.1 Dyrearter, som lægemidlet er beregnet til Hund
English: First dose: Versican Plus DHPPi/L4 from 8-9 weeks of age.
Danish: 1. dosis: Versican Plus DHPPi/L4 fra 8-9-ugers alderen.
English: 103.6 TCID50* 105.3 TCID50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10
Danish: 103,6 TCID50* 105,3 TCID50 Hundeparvovirus type 2b, stamme CPV-2b-Bio 12/B 10
English: Suspension: whitish colour with fine sediment.
Danish: Suspension: Hvidlig væske med fint bundfald.
English: Reconstituted vaccine: pinkish or yellowish colour with slight opalescence.
Danish: Rekonstitueret vaccine: Lyserød eller gullig farve, let opalisering.
English: At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Danish: Mindst 1 år efter basisvaccination for CPiV og Leptospira komponenter.
English: The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
Danish: Vaccinevirusstammen CPV-2b har ikke været testet på kødædende dyr (undtagen hunde og huskatte), som man ved, kan være modtagelige over for hundeparvovira.
English: − to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Danish: − for at forebygge kliniske symptomer og reducere infektion og udskillelse i urinen forårsaget af L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa.
English: Primary vaccination scheme: Two doses of Versican Plus DHPPi/L4 3-4 weeks apart from 6 weeks of age.
Danish: Basisvaccination: To doser af Versican Plus DHPPi/L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen.
English: Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Danish: En enkelt dosis med forligelig Versican Plus Pi/L4vaccine kan derfor anvendes årligt som påkrævet.
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
Danish: − for at forebygge kliniske symptomer (næse- og øjenudflåd) og begrænse virusudskillelse forårsaget af hundeparainfluenzavirus
English: Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Danish: Vaccinen leveres i hætteglas Type I. Hætteglassene med suspension er lukket med en prop af chlorbutylgummi og et aluminiumlåg.
English: − to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,
Danish: − for at forebygge kliniske symptomer, leukopeni og virusudskillelse forårsaget af hundeparvovirus
English: No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
Danish: 6 (Bivirkninger), efter indgift af en overdosis af vaccinen.
English: − to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and
Danish: − for at forebygge kliniske symptomer og udskillelse i urinen og reducere infektion forårsaget af L. interrogans serogruppe Canicola serovar Canicola og L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Danish: Vaccinen leveres i hætteglas Type I. Hætteglassene med lyofilisat er lukket med en prop af brombutylgummi og et aluminiumlåg.
English: PACKAGE LEAFLET: Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus DHPPi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
English: − 3 weeks after the first vaccination for CDV, CAV, CPV,
Danish: Indtræden af immunitet: - 3 uger efter første vaccination for CDV, CAV, CPV - 3 uger efter basisvaccination for CPiV - 4 uger efter basisvaccination for Leptospira komponenter.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 - lyofilisat - til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 - suspension - til hund
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injection
Danish: Dinatriumphosphatdodecahydrat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus DHPPi/L4 lyofilisat og suspension til injektionsvæske, suspension til hund
English: Autologous means that it is derived from the cells in the patient's own body.
Danish: "Autolog" betyder, at det stammer fra celler i patientens egen krop.
English: The effects of Oncophage were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Oncophage blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: What is Oncophage?
Danish: Hvad er Oncophage?
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Oncophage did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Oncophage ikke opvejer risiciene.
English: The Commitee also noted that the company had provided insufficient information on the contents of the medicine and on the manufacturing process.
Danish: CHMP bemærkede ligeledes, at virksomheden havde fremlagt utilstrækkelig information om lægemidlets indhold og om fremstillingsprocessen.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Oncophage is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Oncophage kan ses her.
English: Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour.
Danish: Eftersom proteinerne i vitespen ligner proteinerne i kræftceller, forventedes det, at immunsystemet også ville angribe kræftcellerne og dermed forhindre tilbagevenden eller spredning af den oprindelige tumor.
English: There was also not enough information to clarify the way Oncophage works in renal cell carcinoma and to determine the appropriate dose of the medicine.
Danish: Der var heller ikke fremlagt tilstrækkelig information til at redegøre for, hvordan Oncophage virker ved renalcellekarcinom, og til at bestemme den rette dosis af lægemidlet.
English: What was Oncophage expected to be used for?
Danish: Hvad forventedes Oncophage anvendt til?
English: The active substance in oncophage, vitespen, is made up of proteins (‘heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells.
Danish: Det aktive stof i Oncophage, vitespen, består af proteiner ("heat shock protein/peptid-kompleks 96"), der er blevet udvundet af patientens kræftceller.
English: The main measure of effectiveness was how long the patients lived without the cancer coming back.
Danish: Det primære effektmål var, hvor længe patienterne levede, uden at kræften kom igen.
English: Oncophage was expected to be used in patients with renal cell carcinoma (a type of kidney cancer) that had not yet spread to other parts of the body (localised).
Danish: Oncophage forventedes anvendt til patienter med renalcellekarcinom (en type nyrekræft), som endnu ikke har spredt sig til andre dele af kroppen (lokaliseret).
English: When Oncophage is given to the patient, the body's defence system (immune system) learns to recognize the proteins in vitespen as foreign and triggers an immune response.
Danish: Når Oncophage gives til patienten, lærer kroppens forsvarssystem (immunsystemet) at genkende proteinerne i vitespen som fremmede og udløser en immunrespons.
English: The company presented results of a study involving 818 adults with localised renal cell carcinoma that had been surgically removed and who had a high risk of the cancer coming back.
Danish: Virksomheden fremlagde resultaterne af en undersøgelse, der omfattede 818 voksne med lokaliseret renalcellekarcinom, som var blevet fjernet kirurgisk, og hvor der var høj risiko for, at kræften kom tilbage.
English: It was to be used when there is a high risk of the cancer coming back after the patient has had surgery to remove the tumour.
Danish: Det skulle anvendes, når der er høj risiko for, at kræften kommer igen, efter at patienten har fået tumoren fjernet ved operation.
English: Oncophage is a solution for injection that contains the active substance vitespen (20 micrograms).
Danish: Oncophage er en injektionsvæske, opløsning, som indeholder det aktive stof vitespen (20 mikrogram).
English: The study compared the patients who were given Oncophage with those who were not.
Danish: I undersøgelsen sammenlignede man patienter, som fik Oncophage, med patienter, som ikke fik det.
English: The CHMP was of the opinion that the main study did not show that Oncophage was effective at prolonging the length patients lived without the cancer coming back.
Danish: CHMP var af den opfattelse, at hovedundersøgelsen ikke viste, at Oncophage var effektiv til at forlænge patienternes liv, uden at kræften kom igen.
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: Oncophage is an autologous immunotherapy product.
Danish: Oncophage er et lægemiddel til autolog immunterapi.
English: How was Oncophage expected to work?
Danish: Hvordan forventedes Oncophage at virke?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Oncophage for use as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Oncophage som supplerende behandling efter kirurgi for lokaliseret renalcellekarcinom med høj risiko for tilbagevenden.
English: On 23 November 2009, Antigenics Therapeutics Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Oncophage, intended as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.
Danish: Den 23. november 2009 meddelte Antigenics Therapeutics Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Oncophage som supplerende behandling efter kirurgi for lokaliseret renalcellekarcinom med høj risiko for tilbagevenden.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Oncophage?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske forsøg med Oncophage eller i programmer for anvendelse af Oncophage med særlig udleveringstilladelse?
English: Oncophage was designated as an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 April 2005 for renal cell carcinoma.
Danish: Oncophage blev udpeget som lægemiddel til sjældne sygdomme den 11. april 2005 til behandling af renalcellekarcinom.
English: EMA/830607/2009
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse forT Oncophage (TvitespenT) EMA/830607/2009
English: The company informed the CHMP that there are no patients in the European Union currently receiving Oncophage as part of a clinical trial or a formal compassionate use or named patient programme.
Danish: Virksomheden har informeret CHMP om, at der ikke er nogen patienter, som nu deltager i kliniske undersøgelser med Oncophage eller i programmer for anvendelse af Oncophage med særlig udleveringstilladelse.
English: What documentation did the company present to support its application to the Agency?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen til CHMP?
English: EU-number
Danish: EU-nummer
English: Content (concentration)
Danish: Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: Prolia received a marketing authorisation valid throughout the EU on 26 May 2010.
Danish: Prolia fik en markedsføringstilladelse med gyldighed i hele EU den 26. maj 2010.
English: Further information on Prolia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information vedrørende Prolia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Prolia
Danish: Andre oplysninger om Prolia
English: Prolia is a medicine used to treat the following conditions:
Danish: Prolia er et lægemiddel, der anvendes til at behandle følgende sygdomme:
English: As for all medicines, data on the use of Prolia are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Prolia løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Prolia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Prolia?
English: The medicine contains the active substance denosumab.
Danish: Lægemidlet indeholder det aktive stof denosumab.
English: Side effects reported with Prolia are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Prolia vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Danish: Ved at binde til og blokere RANKL reducerer denosumab dannelsen og aktiviteten af osteoklaster.
English: Prolia can be given by someone who has been trained in how to give injections appropriately.
Danish: Prolia kan gives af en person, der er blevet behørigt instrueret i at give injektionerne.
English: In the second study, the women were receiving treatment for breast cancer and were considered to be at high risk of fracture.
Danish: I det andet studie blev kvinderne behandlet for brystkræft og blev anset for at være i højrisikogruppen for brud.
English: The European Medicines Agency decided that Prolia'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 Prolia opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The active substance in Prolia, denosumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific structure in the body called RANKL.
Danish: Det aktive stof i Prolia, denosumab, er et monoklonalt antistof (en type protein), som er fremstillet, så det genkender og binder til en bestemt struktur i kroppen, der hedder RANKL.
English: An overview of Prolia and why it is authorised in the EU
Danish: En oversigt over Prolia, og hvorfor det er godkendt i EU
English: For more information about using Prolia, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Prolia, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: This reduces the loss of bone and maintains bone strength, making fractures less likely to happen.
Danish: Derved mindskes tabet af knoglemasse og knoglestyrken opretholdes, hvilket gør det mindre sandsynligt, at der opstår brud.
English: The company that markets Prolia will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Danish: Den virksomhed, som markedsfører Prolia, skal udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben og en instruks til patienterne om at kontakte deres læge, hvis de oplever symptomer.
English: What is Prolia and what is it used for?
Danish: Hvad er Prolia, og hvad anvendes det til?