FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours).
Danish: I undersøgelserne måltes mængden af et stof i blodet kaldet »glykosyleret hæmoglobin« (HbA1c), som giver en indikation af, hvor godt blodglukosen reguleres, og mængden af »fastende« blodglukose (målt når patienterne ikke havde spist i mindst otte timer).
English: The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Liprolog opvejer risiciene ved behandling af patienter med diabetes mellitus, som har behov for insulin til opretholdelse af normal glukosehomøostase og til initial stabilisering af diabetes mellitus.
English: In addition, the company that makes Liprolog has provided information to patients and healthcare professionals to remind them that there are two strengths of Liprolog and to advise them on how to use them safely to avoid medication errors.
Danish: Derudover har den virksomhed, der fremstiller Liprolog, indsendt oplysninger til patienter og sundspersonale med påmindelse om, at der findes to styrker af Liprolog, og med rådgivning om, hvordan disse anvendes sikkert, så medicineringsfejl undgås.
English: • Liprolog Basal: insulin lispro protamine suspension;
Danish: • Liprolog Basal: insulin lispro protamin-suspension
English: Liprolog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Danish: Liprolog kan medføre hypoglykæmi (for lavt blodglukoseniveau) og må ikke gives til patienter, hvis blodglukoseniveau i forvejen er lavt.
English: Liprolog Mix, Liprolog Basal and Liprolog 200 units/ml should never be given into a vein.
Danish: Liprolog Mix, Liprolog Basal og Liprolog, 200 enheder/ml, må aldrig gives i en vene.
English: Why has Liprolog been approved?
Danish: Hvorfor blev Liprolog godkendt?
English: The Committee recommended that Liprolog be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Liprolog.
English: Liprolog is a replacement insulin which is very similar to the insulin made by the body.
Danish: Liprolog er en insulinerstatning, der næsten er identisk med det insulin, der produceres af kroppen.
English: The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Danish: Virkningen af Liprolog blev sammenlignet med virkningen af Humulin R (et opløseligt rekombinant DNA-fremstillet humant insulin), når det blev føjet til langtidsvirkende insuliner givet en eller to gange dagligt.
English: Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Danish: Liprolog kan anvendes sammen med en længerevirkende insulin eller med sulfonylurinstoffer (en gruppe diabeteslægemidler, som indtages gennem munden).
English: Liprolog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Danish: Liprolog, 200 enheder/ml, må kun gives ved injektion under huden ved hjælp af den KwikPen-anordning, det leveres i.
English: Liprolog contains the active substance insulin lispro.
Danish: Liprolog indeholder det aktive stof insulin lispro.
English: Liprolog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Danish: Liprolog, 100 enheder/ml, kan også gives ved kontinuerlig infusion ved hjælp af en insulinpumpe eller i en vene.
English: • Liprolog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Danish: • Liprolog: insulin lispro-opløsning, der fås i en standardstyrke eller en højere styrke (100 eller
English: Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Danish: Insulin lispro fås som Liprolog i en opløselig form, som mere eller mindre virker umiddelbart efter injektion, og som Liprolog Basal i form af en »protaminsuspension«, der optages langsommere og derfor virker længere.
English: Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Danish: Liprolog, Liprolog Basal og Liprolog Mix kan gives ved injektion under huden i overarmen, låret, ballerne eller abdomen (maven).
English: The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer-acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix):
Danish: Liprolog-serien omfatter hurtigtvirkende insulinopløsninger (Liprolog), længerevirkende insulinsuspensioner (Liprolog Basal) og kombinationer af disse to i forskellige blandingsforhold (Liprolog Mix):
English: For the full list of all side effects and restrictions with Liprolog, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Liprolog fremgår af indlægssedlen.
English: Liprolog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Danish: Liprolog anvendes til behandling af patienter med diabetes, der har brug for insulin til at regulere deres blodglukose, herunder patienter, hvis diabetes netop er diagnosticeret.
English: How has Liprolog been studied?
Danish: Hvordan blev Liprolog undersøgt?
English: What is Liprolog?
Danish: Hvad er Liprolog?
English: Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Danish: Virkningen af Liprolog svarede til virkningen af Humulin R med hensyn til reguleringen af diabetes, der blev målt i HbA1c og fastende glukosemængder.
English: Liprolog is supplied in vials, cartridges and prefilled pens (Liprolog KwikPen).
Danish: Liprolog fås i hætteglas, cylinderampuller og fyldte penne (Liprolog KwikPen).
English: The active substance in Liprolog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Danish: Det aktive stof i Liprolog, insulin lispro, fremstilles via en metode, der er kendt som »rekombinant DNA-teknologi«.
English: What is Liprolog used for?
Danish: Hvad anvendes Liprolog til?
English: What benefit has Liprolog shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Liprolog?
English: How is Liprolog used?
Danish: Hvordan anvendes Liprolog?
English: How does Liprolog work?
Danish: Hvordan virker Liprolog?
English: It can also be used on its own in:
Danish: Det kan også anvendes alene hos:
English: This was converted into a full marketing authorisation on 20 November 2018.
Danish: Denne blev omdannet til en fuldgyldig markedsføringstilladelse den 20. november 2018.
English: Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016.
Danish: Venclyxto fik en betinget markedsføringstilladelse med gyldighed i hele EU den 5. december 2016.
English: Further information on Venclyxto can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Venclyxto.
Danish: Yderligere information om Venclyxto findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Venclyxto.
English: The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg.
Danish: Startdosen er 20 mg dagligt, og dosen øges gradvist over fem uger til 400 mg.
English: This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines.
Danish: Dette protein findes i store mængder i CLL-kræftcellerne, hvor det hjælper cellerne med at overleve i kroppen i længere tid og gør dem modstandsdygtige over for kræftlægemidler.
English: If the patient experiences certain side effects, treatment may be stopped temporarily or the dose reduced.
Danish: Hvis patienten får visse bivirkninger, kan behandlingen afbrydes midlertidigt, eller dosen nedsættes.
English: Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.
Danish: Selvom der er en risiko for tumorlysesyndrom (en komplikation, der opstår, når kræftcellerne ødelægges for hurtigt), kan dette begrænses ved hjælp af forebyggende foranstaltninger, som f.eks. at øge dosen gradvist eller nedsætte dosen om nødvendigt.
English: For more information about using Venclyxto, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Venclyxto, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: As for all medicines, data on the use of Venclyxto are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Venclyxto løbende overvåget.
English: Patients in this second study had all previously taken B-cell receptor pathway inhibitors.
Danish: Alle patienterne i det andet studie havde tidligere fået B-celle-receptor-hæmmere.
English: Venclyxto is available as tablets (10, 50 and 100 mg) to be taken by mouth once a day with a meal.
Danish: Venclyxto fås som tabletter (10, 50 og 100 mg), der tages gennem munden én gang dagligt sammen med et måltid.
English: A high proportion of patients respond to Venclyxto after other treatments have failed or are unsuitable.
Danish: En stor andel patienter reagerer på Venclyxto, efter at andre behandlinger ikke har virket eller ikke er egnede.
English: The European Medicines Agency decided that Venclyxto's benefits outweigh its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Venclyxto opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Venclyxto are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Venclyxto vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: When Venclyxto is used on its own, treatment should continue for as long as the patient improves or remains stable and the side effects are tolerable.
Danish: Når Venclyxto anvendes alene, bør behandlingen fortsættes, så længe patientens tilstand forbedres eller forbliver stabil, og så længe bivirkningerne tåles.
English: What measures are being taken to ensure the safe and effective use of Venclyxto?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Venclyxto?
English: In another study of 127 patients with or without 17p deletion or TP53 mutation, the response rate was 70%.
Danish: I et andet studie, som omfattede 127 patienter med eller uden 17p-deletion eller TP53-mutation, var responsraten 70 %.
English: The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2.
Danish: Det aktive stof i Venclyxto, venetoclax, binder sig til et protein kaldet Bcl-2.
English: A high response rate was also seen in patients whose previous treatment with ibrutinib or idelalisib failed.
Danish: Desuden sås der en høj responsrate hos patienter, hvis tidligere behandling med ibrutinib eller idelalisib ikke havde virket.
English: Venclyxto should be taken for 24 months from day 1 of the first cycle of rituximab.
Danish: Venclyxto bør tages i 24 måneder fra dag 1 i den første serie med rituximab.
English: Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
Danish: Venclyxto kan anvendes i kombination med rituximab (et andet kræftlægemiddel) hos patienter, som har fået mindst en tidligere behandling.
English: When Venclyxto is used in combination with rituximab, the recommended dose of Venclyxto is 400 mg once a day.
Danish: Når Venclyxto anvendes i kombination med rituximab, er den anbefalede dosis Venclyxto 400 mg en gang dagligt.
English: Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
Danish: Venclyxto er et kræftlægemiddel til behandling af voksne med en type blodkræft, der kaldes kronisk lymfatisk leukæmi (CLL).
English: An overview of Venclyxto and why it is authorised in the EU
Danish: En oversigt over Venclyxto, og hvorfor det er godkendt i EU
English: Another study in 389 patients with CLL who received at least one previous treatment showed that patients treated with Venclyxto plus rituximab lived longer without their disease getting worse (progression-free survival) than patients treated with rituximab and bendamustine (another cancer medicine).
Danish: Et andet studie, som omfattede 389 patienter med CLL, som havde fået mindst én tidligere behandling, at de patienter, der blev behandlet med Venclyxto plus rituximab, levede længere, uden at sygdommen forværredes (progressionsfri overlevelse), end patienter, der blev behandlet med rituximab og bendamustin (et andet kræftlægemiddel).
English: In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto.
Danish: I et hovedstudie, som omfattede 107 tidligere behandlede patienter med CLL og 17p-deletion, responderede 75 % fuldstændig eller delvis på Venclyxto.
English: Patients should have taken Venclyxto at the daily dose of 400 mg for 7 days before starting therapy with rituximab.
Danish: Patienterne bør have taget den daglige dosis på 400 mg Venclyxto i syv dage, før behandlingen med rituximab påbegyndes.
English: • patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B-cell receptor pathway inhibitor have both failed.
Danish: • patienter, der ikke har disse genetiske forandringer, når behandlinger med kemoimmunterapi og en B-celle-receptor-hæmmer ikke har virket.
English: Venclyxto should be started and supervised by a doctor with experience of cancer medicines and can only be obtained with a prescription.
Danish: Venclyxto-behandlingen bør påbegyndes og overvåges af en læge med erfaring i anvendelse af kræftlægemidler, og lægemidlet udleveres kun efter recept.
English: When used in combination with rituximab, Venclyxto was shown to prolong the time patients lived without their disease getting worse.
Danish: Når Venclyxto blev anvendt i kombination med rituximab, viste det sig at forlænge den tid, patienterne levede, uden at sygdommen blev værre.
English: Other information about Venclyxto
Danish: Andre oplysninger om Venclyxto
English: Venclyxto contains that active substance venetoclax.
Danish: Venclyxto indeholder det aktive stof venetoclax.
English: Why is Venclyxto authorised in the EU?
Danish: Hvorfor blev Venclyxto godkendt i EU?
English: In these patients, Venclyxto is used when medicines known as B-cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
Danish: Venclyxto, når lægemidler kaldet B-celle-receptor-hæmmere (ibrutinib og idelalisib) ikke er egnede eller ikke virker.
English: • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment).
Danish: • patienter, der har en særlig type genetiske forandringer (17p-deletion eller TP53-mutation), som gør dem uegnede til kemoimmunterapi (en type kræftbehandling).
English: What is Venclyxto and what is it used for?
Danish: Hvad er Venclyxto, og hvad anvendes det til?
English: By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down the progression of the disease.
Danish: Venetoclax binder sig til Bcl-2-proteinet og blokerer dets aktivitet, så kræftcellerne dør, og sygdomsudviklingen dermed bremses.
English: The most common side effects when Venclyxto is used with rituximab are low level of neutrophils, diarrhoea and nose and throat infection.
Danish: De hyppigste bivirkninger, når Venclyxto anvendes sammen med rituximab, er nedsat antal neutrofiler, diarré og infektioner i næse og hals.
English: What are the risks associated with Venclyxto?
Danish: Hvilke risici er der forbundet med Venclyxto?
English: Studies have shown that a high proportion of patients have their cancer cells partially or completely cleared following treatment with Venclyxto on its own.
Danish: Studier har vist, at kræftcellerne helt eller delvist forsvinder hos en stor del af de patienter, der behandles med Venclyxto alene.
English: The most common serious side effects (seen in more than 2 in 100 people) in patients receiving Venclyxto in combination with rituximab or on its own are pneumonia (lung infection), fever associated with reduced neutrophils and tumour lysis syndrome (a complication caused by breakdown of cancer cells).
Danish: De hyppigste alvorlige bivirkninger (som optræder hos mere end 2 ud af 100 patienter) hos patienter, som får Venclyxto i kombination med rituximab eller alene, er lungebetændelse (pneumoni), feber forbundet med nedsat antal neutrofiler og tumorlysesyndrom (en komplikation, der skyldes nedbrydningen af kræftceller).
English: The most common side effects with Venclyxto used on its own (seen in more than 1 in 5 people) are low levels of neutrophils (a type of white blood cell), diarrhoea, nausea, anaemia (low red blood cell counts), nose and throat infection and tiredness.
Danish: De hyppigste bivirkninger ved Venclyxto anvendt alene (som optræder hos mere end 1 ud af 5 patienter) er nedsat antal neutrofiler (en type hvide blodlegemer), diarré, kvalme, blodmangel (lavt antal røde blodlegemer), infektioner i næse og hals og træthed.
English: Studies showed patients with particular genetic mutations (17p deletion or TP53 mutations) that make them unsuitable for chemo-immunotherapy responding well to Venclyxto used on its own.
Danish: Studier har vist, at patienter med bestemte genetiske forandringer (17p-deletion eller TP53mutationer), der gør dem uegnede til kemoimmunterapi, har stor gavn af behandling med Venclyxto anvendt alene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Venclyxto 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 Venclyxto.
English: For the full list of side effects with Venclyxto, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Venclyxto fremgår af indlægssedlen.
English: Regarding safety, the medicine's side effects are considered acceptable.
Danish: For så vidt angår sikkerheden, anses bivirkningerne ved Venclyxto for at være acceptable.
English: How is Venclyxto used?
Danish: Hvordan anvendes Venclyxto?
English: What benefits of Venclyxto have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Venclyxto?
English: How does Venclyxto work?
Danish: Hvordan virker Venclyxto?
English: Venclyxto must not be used with medicines known as ‘strong CYP3A inhibitors' during the early stages of treatment and must also not be used with St. John's wort (a herbal preparation used to treat anxiety and depression).
Danish: Desuden må Venclyxto ikke anvendes sammen med prikbladet perikon (et naturlægemiddel til behandling af angst og depression).
English: The European Commission granted a marketing authorisation valid throughout the EU for Vectormune ND on 8 September 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Vectormune ND den 8. september 2015.
English: However, precautionary measures must be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Danish: Der skal dog følges forsigtighedsregler til at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner.
English: The full EPAR for Vectormune ND can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Vectormune ND findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Vectormune ND.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vectormune ND.
English: Safety studies have shown that the strain is safe for turkeys.
Danish: Sikkerhedsundersøgelser har vist, at stammen er sikker for kalkuner.
English: In the future if the animals are exposed to a similar virus and/or to a virus expressing a similar fusion protein, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for et tilsvarende virus og/eller et virus, der udtrykker et tilsvarende fusionsprotein, vil immunsystemet reagere hurtigere.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vectormune ND's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Vectormune ND opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The withdrawal period for meat and eggs from chickens treated with Vectormune ND is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger, der behandles med Vectormune ND, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The vaccine protects against a type of Marek disease virus that can cause visible infection.
Danish: Vaccinen beskytter imod en type Mareks sygdomsvirus, der kan forårsage synlig infektion.
English: Two field studies were conducted in around 120,000 broiler chickens to evaluate the effects of the vaccine.
Danish: Der er udført to feltundersøgelser hos omkring 120 000 slagtekyllinger til vurdering af vaccinens virkninger.
English: Newcastle disease and Marek's disease vaccine (live recombinant)
Danish: Newcastle disease og Mareks sygdom vaccine (levende, rekombinant)
English: As the vaccine is stored in liquid nitrogen, it is important that any handling is done by appropriately trained personnel in a well-ventilated area and that precautions are taken when preparing the vaccine.
Danish: Da vaccinen opbevares i flydende kvælstof, er det vigtigt, at den håndteres af passende oplært personale i et velventileret rum, og at der træffes forsigtighedsregler ved klargøring af vaccinen.
English: For further information see the summary of product characteristics.
Danish: Yderligere oplysninger fremgår af produktresuméet.
English: No signs of MDV or NDV outbreaks were detected from samples taken from both groups at days 35, 66, 102 and completion at day 118.
Danish: Der blev ikke set nogen tegn på udbrud af Mareks sygdomsvirus eller Newcastle disease-virus i prøver taget fra begge grupper på dag 35, 66, 102 og ved afslutningen på dag 118.
English: Since Vectormune ND is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Danish: Da Vectormune ND er en levende vaccine, udskilles vaccinestammen fra vaccinerede fugle og kan spredes til kalkuner.