FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit of Florgane 300 mg/ml suspension for injection is that swine respiratory disease associated with susceptible Actinobacillus pleuropneumoniae and Pasteurella multocida can be treated.
Danish: Fordelen ved Florgane, injektionsvæske, suspension, 300 mg/ml, er, at det giver mulighed for behandling af luftvejssygdom hos svin forårsaget af følsomme stammer af Actinobacillus pleuropneumoniae og Pasteurella multocida.
English: The applicant submitted an application for a decentralised procedure for Florgane 300 mg/ml suspension for injection for cattle and pigs and associated names.
Danish: Ansøgeren har indgivet en ansøgning via den decentrale procedure for Florgane, injektionsvæske, suspension, 300 mg/ml, og relaterede navne for kvæg og svin.
English: The reference product was Nuflor Swine Injectable Solution 300 mg/ml.
Danish: Referenceproduktet var Nuflor Swine injektionsvæske, opløsning, 300 mg/ml.
English: This application is an extension to add pigs as a target species to the existing 300 mg florfenicol/ml suspension for injection product authorised for use in cattle.
Danish: Ansøgningen vedrører en udvidelse gennem tilføjelse af måldyrearten svin for det eksisterende produkt, florfenicol, injektionsvæske, suspension, 300 mg/ml, der er godkendt til anvendelse hos kvæg.
English: Considering the MIC data from most recent isolates, obtained from pigs suffering from respiratory disease in the last 5 years florfenicol exhibited consistent MICs with MIC90 ranges of 0.25-1 µg/ml for
Danish: Af MIC-værdierne for de isolater, der de seneste fem år er indsamlet fra svin med luftvejssygdom, ses, at florfenicol vedholdende har haft MIC-værdier på 0,25-1 µg/ml over for hver stamme af A. pleuropneumoniae og 0,5 µg/ml for P. multocida.
English: In conclusion, the benefit-risk ratio is considered positive for Florgane300 mg/ml suspension for injection for cattle and pigs.
Danish: Som konklusion anses benefit/risk-forholdet for positivt for Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg og svin.
English: Scientific conclusions and grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Danish: Videnskabelige konklusioner og begrundelse for udvidelse af markedsføringstilladelsen for Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg, til at omfatte måldyrearten svin
English: Thus, the impact on development of florfenicol resistance when used in the proposed dose of 22.5 mg/kg bw IM once compared to authorised dosing regimens can hardly be estimated.
Danish: Det er derfor vanskeligt at vurdere, hvordan den ansøgte dosering på en enkelt intramuskulær injektion af 22,5 mg/kg kropsvægt indvirker på resistensudviklingen over for florfenicol sammenlignet med godkendte doseringsregimer.
English: Spain1
Danish: Spanien 1
English: Belgium Emdoka bvba John Lijsenstraat 16
Danish: Bulgarien Emdoka bvba John Lijsenstraat 16
English: Overall summary of the scientific evaluation of Florgane 300 mg/ml suspension for injection for cattle and pigs
Danish: Samlet resumé af den videnskabelige vurdering af Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg og svin
English: The overall conclusion is that that the efficacy dataset as a whole is adequate to support the efficacy of the product in target species pigs at the dose of 22.5 mg florfenicol/kg body weight given by intramuscular administration as a single injection for the treatment of respiratory infections caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.
Danish: • der menes ikke at være en stigning i risikoen for udvikling af antimikrobiel resistens er den samlede konklusion, at dokumentationen af virkningen som helhed er tilstrækkelig til støtte for produktets anvendelse til måldyrearten svin ved behandling af luftvejssygdomme, der forårsages af florfenicolfølsomme stammer af Actinobacillus pleuropneumoniae og Pasteurella multocida, i en dosis af 22,5 mg florfenicol/kg kropsvægt, indgivet som en enkelt intramuskulær injektion.
English: Czech Republic Emdoka bvba John Lijsenstraat 16
Danish: Nederlandene Emdoka bvba John Lijsenstraat 16
English: The Member States concerned failed to reach an agreement in respect of the extension of the marketing authorisation of Florgane 300 mg/ml suspension for injection for cattle to the target species pigs and consequently the matter was referred to the CVMP on 19 April 2012.
Danish: De berørte medlemsstater var ikke i stand til at nå til enighed om udvidelse af markedsføringstilladelsen for Florgane, injektionsvæske, suspension, 300 mg/ml, for kvæg til måldyrearten svin.
English: Grounds for the granting of the extension of the marketing authorisation for Florgane 300 mg/ml suspension for injection for cattle to the target species pigs
Danish: Begrundelse for udvidelse af markedsføringstilladelsen for Florgane, injektionsvæske, suspension, 300 mg/ml, til kvæg, til at omfatte måldyrearten svin.
English: Greece
Danish: Belgian
English: Opdivo received a marketing authorisation valid throughout the EU on 19 June 2015.
Danish: Opdivo fik en markedsføringstilladelse med gyldighed i hele EU den 19. juni 2015.
English: Melanoma
Danish: Melanom
English: Classical Hodgkin lymphoma
Danish: Klassisk Hodgkins lymfom
English: As for all medicines, data on the use of Opdivo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Opdivo løbende overvåget.
English: • melanoma, a type of skin cancer.
Danish: • melanom, en type hudkræft.
English: Further information on Opdivo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/opdivo.
Danish: Yderligere information om Opdivo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/opdivo.
English: Other information about Opdivo
Danish: Andre oplysninger om Opdivo
English: The medicine can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun på recept.
English: An overview of Opdivo and why it is authorised in the EU
Danish: En oversigt over Opdivo, og hvorfor det er godkendt i EU
English: Studies of classical Hodgkin lymphoma involved only a small number of patients.
Danish: Studier af klassisk Hodgkins lymfom omfattede kun et lavt antal patienter.
English: What measures are being taken to ensure the safe and effective use of Opdivo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Opdivo?
English: The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Danish: Lægen kan være nødt til at udsætte behandlingen, hvis der opstår visse bivirkninger, eller helt standse den, hvis bivirkningerne er alvorlige.
English: Opdivo is also commonly associated with side effects related to the activity of the immune system on body organs.
Danish: Opdivo er også sædvanligvis forbundet med bivirkninger, der er knyttet til immunsystemets aktivitet på kroppens organer.
English: Urothelial cancer
Danish: Urotelial kræft
English: Opdivo contains the active substance nivolumab.
Danish: Opdivo indeholder det aktive stof nivolumab.
English: For more information about using Opdivo, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Opdivo, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: After treatment, cancer cells were partially or completely cleared in around 66% of patients (63 out of 95).
Danish: Efter behandlingen var kræftcellerne helt eller delvist forsvundet hos ca. 66 % af patienterne (63 ud af 95).
English: Opdivo was used on its own and not compared with any other medicine.
Danish: Opdivo blev anvendt alene og blev ikke sammenlignet med andre lægemidler.
English: Treatment with Opdivo must be started and supervised by a doctor experienced treating cancer.
Danish: Behandling med Opdivo skal indledes og overvåges af en læge med erfaring i behandling af kræft.
English: The dose and frequency to be given depends on the condition and whether it is used alone or in combination with ipilimumab.
Danish: Den anvendte dosis og hyppigheden afhænger af sygdommen og af, om lægemidlet anvendes alene eller i kombination med ipilimumab.
English: The Agency therefore decided that Opdivo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Opdivo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Why is Opdivo authorised?
Danish: Hvorfor er Opdivo godkendt?
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms.
Danish: Virksomheden udleverer desuden et patientinformationskort med oplysninger om risiciene ved lægemidlet og anvisninger om, hvornår de skal kontakte lægen, hvis de oplever symptomer.
English: As it is not clear how much ipilimumab contributes to the benefits when given in combination with Opdivo in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of ipilimumab and if the risks associated with ipilimumab can be further minimised.
Danish: Da der ikke er klarhed over, i hvor høj grad ipilimumab bidrager til fordelene, når det gives i kombination med Opdivo hos patienter med fremskredent renalcellekarcinom, skal virksomheden gennemføre et studie med henblik på at bestemme ipilimumabs præcise bidrag, og om de risici, der er forbundet med ipilimumab, kan minimeres yderligere.
English: What is Opdivo and what is it used for?
Danish: Hvad er Opdivo, og hvad anvendes det til?
English: Most will go away with appropriate treatment or on stopping Opdivo.
Danish: De fleste svinder ved passende behandling, eller når behandlingen med Opdivo standses.
English: However, high response rates were seen in these patients, in whom other treatments had failed and who had few other treatment options.
Danish: Der sås dog en høj responsrate hos disse patienter, for hvem andre behandlinger ikke havde virket, og for hvem der kun var få andre behandlingsmuligheder.
English: Opdivo is a cancer medicine used to treat the following:
Danish: Opdivo er et lægemiddel mod kræft, der anvendes til behandling af følgende:
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Danish: Desuden reagerede 41,6 % af patienterne (177 ud af 423) på behandlingen med kombinationen sammenlignet med 26,5 % (112 ud af 416) af dem, der fik sunitinib.
English: Side effects reported with Opdivo are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Opdivo vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: Opdivo is given as an infusion (drip) into a vein.
Danish: Opdivo gives som infusionsvæske (drop) i en vene.
English: The European Medicines Agency considered that Opdivo has been convincingly shown to benefit patients with certain advanced cancers (melanoma, NSCLC, renal cell carcinoma or SCCHN) by either increasing patients' survival or the time they could live without their disease getting worse.
Danish: Det Europæiske Lægemiddelagentur fandt, at Opdivo på overbevisende måde har vist sig at være til gavn for patienter med visse fremskredne kræftsygdomme (melanom, NSCLC, nyrecellekarcinom eller SCCHN), enten ved at forlænge patienternes overlevelse eller den tid, de kunne leve, uden at deres sygdom forværredes.
English: It is used on its own when treatment with platinum-based cancer medicines has not worked.
Danish: Det anvendes alene, når behandling med platinholdige kræftlægemidler ikke har virket.
English: In studies of urothelial cancer where other treatments had failed, patients responded to treatment with Opdivo.
Danish: I studier i forbindelse med urotelial kræft, hvor andre behandlinger ikke havde virket, responderede patienterne på behandlingen med Opdivo.
English: More patients were alive after 2 years with Opdivo and ipilimumab treatment (64%) than with Opdivo alone (59%) or ipilimumab alone (45%).
Danish: Flere patienter var i live efter to års behandling med Opdivo og ipilimumab (64 %) end med Opdivo alene (59 %) eller ipilimumab alene (45 %).
English: The study included patients whose cancer cells produced high levels of PD-L1 as well as patients whose cancer cells produced low levels of PD-L1.
Danish: Studiet omfattede både patienter, hvis kræftceller producerede et højt antal PD-L1, og patienter, hvis kræftceller producerede et lavt antal PD-L1.
English: • classical Hodgkin lymphoma, a cancer of the lymphocytes (a type of white blood cell), that has not improved or has returned after an autologous stem cell transplant (a procedure where the bone marrow is replaced with the patient's own stem cells to form new bone marrow that produces healthy blood cells).
Danish: • klassisk Hodgkins lymfom, dvs. kræft i lymfocytterne (en type hvide blodceller), som ikke er bedret eller som er vendt tilbage efter en autolog stamcelletransplantation (en procedure, hvor knoglemarven udskiftes med patientens egne stamceller for at skabe ny knoglemarv, der kan producere sunde blodceller).
English: It is also used on its own in patients who have had surgery for the removal of melanoma that has spread to the lymph nodes or elsewhere in the body.
Danish: Det anvendes også alene hos patienter, der ved operation har fået fjernet melanom, som har spredt sig til lymfeknuderne eller andre steder i kroppen.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Danish: Den tid, patienterne levede, før deres sygdom blev værre, var 11,6 måneder ved kombinationen af patienter sammenlignet med 8,4 med sunitinib.
English: What are the risks associated with Opdivo?
Danish: Hvilke risici er der forbundet med Opdivo?
English: The company that markets Opdivo will provide educational packs for doctors who are expected to prescribe Opdivo containing information on how the medicine should be used, how to manage side effects, particularly those related to the activity of the immune system, and possible risks for classical Hodgkin lymphoma patients if they go on to have an allogeneic stem cell transplant (a transplant of stem cells from a donor).
Danish: Virksomheden, der markedsfører Opdivo, vil udlevere oplysningsmateriale til læger, der forventes at ordinere Opdivo, hvori der redegøres for, hvordan lægemidlet anvendes, og hvordan bivirkningerne håndteres, navnlig bivirkninger på immunsystemets aktivitet og mulige risici for patienter med klassisk Hodgkins lymfom, hvis de går videre til at få en allogen stamcelletransplantation (en transplantation af stamceller fra en donor).
English: The average survival with Opdivo was 12.2 months, compared with 9.4 months with docetaxel.
Danish: Den gennemsnitlige overlevelse med Opdivo var 12,2 måneder sammenlignet med 9,4 måneder med docetaxel.
English: Side effects from Opdivo were considered manageable with appropriate measures and were outweighed by the benefits.
Danish: Bivirkningerne ved Opdivo ansås for at kunne håndteres med passende forholdsregler og blev opvejet af fordelene.
English: Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Danish: Kræftceller kan producere proteiner (PD-L1 og PD-L2), der binder sig til denne receptor og afbryder T-cellernes aktivitet, så de ikke kan angribe kræften.
English: The company will also provide further data on the long-term benefits of Opdivo and carry out studies to try to identify which patients are most likely to benefit from treatment with the medicine.
Danish: Virksomheden forelægger derudover yderligere data om de langsigtede fordele ved Opdivo og foretager analyser med henblik på at udpege de patienter, der forventes at få størst gavn af lægemidlet.
English: Opdivo was used on its own and was compared with another cancer medicine (cetuximab, methotrexate or docetaxel) chosen by the treating doctor.
Danish: Opdivo blev anvendt alene og sammenlignet med et andet kræftlægemiddel (cetuximab, methotrexat eller docetaxel) valgt af den behandlende læge.
English: In this study, where patients were followed up for at least 6 months, around 32% (38 out of 120) of patients given Opdivo responded to treatment and had a reduction in their tumours compared with about 11% (5 out of 47) of patients given investigator's choice of treatment (dacarbazine or a combination of carboplatin and paclitaxel).
Danish: I dette studie, hvor der blev fulgt op på patienterne i mindst seks måneder, udviste ca. 32 % (38 ud af 120) af de patienter, der fik Opdivo, respons på behandlingen og tegn på, at deres svulster aftog i størrelse, sammenlignet med ca. 11 % (5 ud af 47) af de patienter, der fik en behandling valgt af undersøgeren (dacarbazin eller en kombination af carboplatin og paclitaxel).
English: In the study, 20% of patients (54 out of 270) responded to treatment and had a tumour size reduction.
Danish: 20 % af patienterne i studiet (54 ud af 270) responderede på behandlingen, og deres svulst blev mindre.
English: Patients given only ipilimumab lived for 2.9 months without their disease getting worse.
Danish: De patienter, som fik ipilimumab alene, levede i 2,9 måneder, uden at deres sygdom forværredes.
English: For the full list of side effects and restrictions with Opdivo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Opdivo fremgår af indlægssedlen.
English: The active substance in Opdivo, nivolumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Danish: Det aktive stof i Opdivo, nivolumab, er et monoklonalt antistof, dvs. en type protein, der er opbygget, så det genkender og binder sig til en receptor kaldet PD-1, som findes på bestemte celler i immunsystemet kaldet T-celler.
English: Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
Danish: Opdivo anvendes alene efter behandling med brentuximab vedotin (et andet kræftlægemiddel)
English: Patients treated with Opdivo lived on average 31 months before the cancer came back or before a new melanoma occurred or they died, compared with 24 months for patients treated with ipilimumab.
Danish: De patienter, som var blevet behandlet med Opdivo, levede i gennemsnit 31 måneder, før kræften vendte tilbage, eller før de fik et nyt melanom eller døde, sammenlignet med 24 måneder for patienter behandlet med ipilimumab.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Danish: Efter 24 måneder var 66,5 % af de patienter, der fik kombinationsbehandlingen, stadig i live, sammenlignet med 52,9 % af dem, der fik sunitinib.
English: Advanced renal cell carcinoma
Danish: Fremskredent nyrecellekarcinom
English: Patients who were given Opdivo plus ipilimumab lived for another 11.5 months without their disease getting worse and patients given only Opdivo lived for another 6.9 months without their disease getting worse.
Danish: De patienter, som fik Opdivo plus ipilimumab, levede i yderligere 11,5 måned, uden at deres sygdom forværredes, og de patienter, som fik Opdivo alene, levede i yderligere 6,9 måneder, uden at deres sygdom forværredes.
English: The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Danish: Af resultaterne fremgik det, at hos patienter med moderat eller høj risiko for sygdomsforværring levede de patienter, der fik kombinationsbehandlingen, samlet set længere end dem, der fik sunitinib.
English: A fourth study in 945 previously untreated advanced melanoma adult patients investigated Opdivo in combination with ipilimumab, Opdivo used alone or ipilimumab used alone.
Danish: I et fjerde studie med 945 tidligere ubehandlede patienter med fremskredent melanom blev Opdivo undersøgt i kombination med ipilimumab, foruden Opdivo anvendt alene eller ipilimumab anvendt alene.
English: Other common side effects with Opdivo in combination with ipilimumab, which are also mostly mild or moderate, include pyrexia (fever), thyroid issues, decreased appetite, vomiting, colitis (inflammation of the gut), abdominal (belly) pain, headache and breathing difficulty.
Danish: De øvrige almindelige bivirkninger ved Opdivo i kombination med ipilimumab, som også for det meste er milde eller moderate, er feber, problemer med skjoldbruskkirtlen, nedsat appetit, opkastning, colitis (inflammation af tarmen), mavesmerter, hovedpine og vejrtrækningsbesvær.
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Opdivo and ipilimumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Danish: Et hovedstudie med 1.096 voksne med tidligere ubehandlet fremskredent nyrecellekarcinom sammenlignede behandling med Opdivo og ipilimumab med behandling med et andet kræftlægemiddel mod nyrecellekarcinom, sunitinib.
English: The first study, involving 418 previously untreated advanced melanoma patients, found that patients treated with Opdivo survived longer than patients who received the cancer medicine dacarbazine: 73% of patients treated with Opdivo were alive at 12 months compared with 42% of patients given dacarbazine.
Danish: I det første studie, som omfattede 418 tidligere ubehandlede patienter med fremskredent melanom, blev det påvist, at patienter, der fik Opdivo, overlevede i længere tid end dem, der fik kræftlægemidlet dacarbazin: 73 % af de patienter, der blev behandlet med Opdivo, var stadig i live efter 12 måneder sammenlignet med 42 % af dem, der fik dacarbazin.
English: Opdivo was studied in one main study and a supportive study involving a total of 95 adults with classical Hodgkin lymphoma whose disease had not responded or had returned after autologous stem cell transplantation and treatment with brentuximab vedotin.
Danish: Opdivo var genstand for et hovedstudie og et underbyggende studie hos i alt 95 voksne med klassisk Hodgkins lymfom, der ikke havde udvist respons på, eller hvis sygdom var vendt tilbage efter autolog stamcelletransplantation og behandling med brentuximab vedotin.
English: • a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body.
Danish: • lungekræft, der kaldes ikkesmåcellet lungekræft (NSCLC), som har spredt sig lokalt eller til andre dele af kroppen.
English: For squamous NSCLC, a study involving 272 adults showed that patients given Opdivo survived for 9.2 months, compared with 6.0 months in patients given docetaxel.
Danish: Et studie vedrørende skvamøs NSCLC, der omfattede 272 voksne, viste, at de patienter, der fik Opdivo, overlevede i 9,2 måneder sammenlignet med 6,0 måneder hos de patienter, der fik docetaxel.
English: Patients given Opdivo survived on average for 7.5 months, compared with 5.1 months in patients given other treatments.
Danish: De patienter, der fik Opdivo, overlevede gennemsnitligt i 7,5 måned sammenlignet med 5,1 måned for de patienter, der fik andre behandlinger.
English: • squamous cell cancer of the head and neck (SCCHN) that has come back or spread to other parts of the body.
Danish: • pladecellekræft i hovedet og halsen (SCCHN), som er kommet tilbage, eller som har spredt sig til andre dele af kroppen.
English: How is Opdivo used?
Danish: Hvordan anvendes Opdivo?
English: Supportive information was also provided from another study indicating that Opdivo could produce a response in patients with squamous NSCLC whose disease had progressed despite several previous treatments.
Danish: Af underbyggende oplysninger fra et andet studie fremgik det også, at Opdivo kunne fremkalde en respons hos patienter med skvamøs NSCLC, hvis sygdom var forværret på trods af flere tidligere behandlinger.