natgillin/translations-raw huggingface dataset:
Liprolog-serien omfatter hurtigtvirkende insulinopløsninger (Liprolog), længerevirkende insulinsuspensioner (Liprolog Basal) og kombinationer af disse to i forskellige blandingsforhold (Liprolog Mix): 
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):
Den fuldstændige liste over bivirkninger og begrænsninger ved Liprolog fremgår af indlægssedlen. 
For the full list of all side effects and restrictions with Liprolog, see the package leaflet.
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. 
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.
Hvordan blev Liprolog undersøgt? 
How has Liprolog been studied?
Hvad er Liprolog? 
What is Liprolog?
Virkningen af Liprolog svarede til virkningen af Humulin R med hensyn til reguleringen af diabetes, der blev målt i HbA1c og fastende glukosemængder. 
Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Liprolog fås i hætteglas, cylinderampuller og fyldte penne (Liprolog KwikPen). 
Liprolog is supplied in vials, cartridges and prefilled pens (Liprolog KwikPen).
Det aktive stof i Liprolog, insulin lispro, fremstilles via en metode, der er kendt som »rekombinant DNA-teknologi«. 
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.
Hvad anvendes Liprolog til? 
What is Liprolog used for?
Hvilken fordel viser undersøgelserne, at der er ved Liprolog? 
What benefit has Liprolog shown during the studies?
Hvordan anvendes Liprolog? 
How is Liprolog used?
Hvordan virker Liprolog? 
How does Liprolog work?
Det kan også anvendes alene hos: 
It can also be used on its own in:
Denne blev omdannet til en fuldgyldig markedsføringstilladelse den 20. november 2018. 
This was converted into a full marketing authorisation on 20 November 2018.
Venclyxto fik en betinget markedsføringstilladelse med gyldighed i hele EU den 5. december 2016. 
Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016.
Yderligere information om Venclyxto findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Venclyxto. 
Further information on Venclyxto can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Venclyxto.
Startdosen er 20 mg dagligt, og dosen øges gradvist over fem uger til 400 mg. 
The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg.
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. 
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.
Hvis patienten får visse bivirkninger, kan behandlingen afbrydes midlertidigt, eller dosen nedsættes. 
If the patient experiences certain side effects, treatment may be stopped temporarily or the dose reduced.
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. 
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.
For mere information om brug af Venclyxto, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Venclyxto, see the package leaflet or contact your doctor or pharmacist.
Som for alle lægemidler bliver data vedrørende brug af Venclyxto løbende overvåget. 
As for all medicines, data on the use of Venclyxto are continuously monitored.
Alle patienterne i det andet studie havde tidligere fået B-celle-receptor-hæmmere. 
Patients in this second study had all previously taken B-cell receptor pathway inhibitors.
Venclyxto fås som tabletter (10, 50 og 100 mg), der tages gennem munden én gang dagligt sammen med et måltid. 
Venclyxto is available as tablets (10, 50 and 100 mg) to be taken by mouth once a day with a meal.
En stor andel patienter reagerer på Venclyxto, efter at andre behandlinger ikke har virket eller ikke er egnede. 
A high proportion of patients respond to Venclyxto after other treatments have failed or are unsuitable.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Venclyxto opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Venclyxto's benefits outweigh its risks and it can be authorised for use in the EU.
Bivirkninger rapporteret for Venclyxto vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Venclyxto are carefully evaluated and any necessary action taken to protect patients.
Når Venclyxto anvendes alene, bør behandlingen fortsættes, så længe patientens tilstand forbedres eller forbliver stabil, og så længe bivirkningerne tåles. 
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Venclyxto? 
What measures are being taken to ensure the safe and effective use of Venclyxto?
I et andet studie, som omfattede 127 patienter med eller uden 17p-deletion eller TP53-mutation, var responsraten 70 %. 
In another study of 127 patients with or without 17p deletion or TP53 mutation, the response rate was 70%.
Det aktive stof i Venclyxto, venetoclax, binder sig til et protein kaldet Bcl-2. 
The active substance in Venclyxto, venetoclax, attaches to a protein called Bcl-2.
Desuden sås der en høj responsrate hos patienter, hvis tidligere behandling med ibrutinib eller idelalisib ikke havde virket. 
A high response rate was also seen in patients whose previous treatment with ibrutinib or idelalisib failed.
Venclyxto bør tages i 24 måneder fra dag 1 i den første serie med rituximab. 
Venclyxto should be taken for 24 months from day 1 of the first cycle of rituximab.
Venclyxto kan anvendes i kombination med rituximab (et andet kræftlægemiddel) hos patienter, som har fået mindst en tidligere behandling. 
Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
Når Venclyxto anvendes i kombination med rituximab, er den anbefalede dosis Venclyxto 400 mg en gang dagligt. 
When Venclyxto is used in combination with rituximab, the recommended dose of Venclyxto is 400 mg once a day.
Venclyxto er et kræftlægemiddel til behandling af voksne med en type blodkræft, der kaldes kronisk lymfatisk leukæmi (CLL). 
Venclyxto is a cancer medicine used to treat adults with a blood cancer known as chronic lymphocytic leukaemia (CLL).
En oversigt over Venclyxto, og hvorfor det er godkendt i EU 
An overview of Venclyxto and why it is authorised in the EU
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). 
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).
I et hovedstudie, som omfattede 107 tidligere behandlede patienter med CLL og 17p-deletion, responderede 75 % fuldstændig eller delvis på Venclyxto. 
In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto.
Patienterne bør have taget den daglige dosis på 400 mg Venclyxto i syv dage, før behandlingen med rituximab påbegyndes. 
Patients should have taken Venclyxto at the daily dose of 400 mg for 7 days before starting therapy with rituximab.
• patienter, der ikke har disse genetiske forandringer, når behandlinger med kemoimmunterapi og en B-celle-receptor-hæmmer ikke har virket. 
• patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B-cell receptor pathway inhibitor have both failed.
Venclyxto-behandlingen bør påbegyndes og overvåges af en læge med erfaring i anvendelse af kræftlægemidler, og lægemidlet udleveres kun efter recept. 
Venclyxto should be started and supervised by a doctor with experience of cancer medicines and can only be obtained with a prescription.
Når Venclyxto blev anvendt i kombination med rituximab, viste det sig at forlænge den tid, patienterne levede, uden at sygdommen blev værre. 
When used in combination with rituximab, Venclyxto was shown to prolong the time patients lived without their disease getting worse.
Andre oplysninger om Venclyxto 
Other information about Venclyxto
Venclyxto indeholder det aktive stof venetoclax. 
Venclyxto contains that active substance venetoclax.
Hvorfor blev Venclyxto godkendt i EU? 
Why is Venclyxto authorised in the EU?
Venclyxto, når lægemidler kaldet B-celle-receptor-hæmmere (ibrutinib og idelalisib) ikke er egnede eller ikke virker. 
In these patients, Venclyxto is used when medicines known as B-cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
• patienter, der har en særlig type genetiske forandringer (17p-deletion eller TP53-mutation), som gør dem uegnede til kemoimmunterapi (en type kræftbehandling). 
• patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment).
Hvad er Venclyxto, og hvad anvendes det til? 
What is Venclyxto and what is it used for?
Venetoclax binder sig til Bcl-2-proteinet og blokerer dets aktivitet, så kræftcellerne dør, og sygdomsudviklingen dermed bremses. 
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.
De hyppigste bivirkninger, når Venclyxto anvendes sammen med rituximab, er nedsat antal neutrofiler, diarré og infektioner i næse og hals. 
The most common side effects when Venclyxto is used with rituximab are low level of neutrophils, diarrhoea and nose and throat infection.
Hvilke risici er der forbundet med Venclyxto? 
What are the risks associated with Venclyxto?
Studier har vist, at kræftcellerne helt eller delvist forsvinder hos en stor del af de patienter, der behandles med Venclyxto alene. 
Studies have shown that a high proportion of patients have their cancer cells partially or completely cleared following treatment with Venclyxto on its own.
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). 
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).
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. 
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.
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. 
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.
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. 
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.
Den fuldstændige liste over indberettede bivirkninger ved Venclyxto fremgår af indlægssedlen. 
For the full list of side effects with Venclyxto, see the package leaflet.
For så vidt angår sikkerheden, anses bivirkningerne ved Venclyxto for at være acceptable. 
Regarding safety, the medicine's side effects are considered acceptable.
Hvordan anvendes Venclyxto? 
How is Venclyxto used?
Hvilke fordele viser studierne, at der er ved Venclyxto? 
What benefits of Venclyxto have been shown in studies?
Hvordan virker Venclyxto? 
How does Venclyxto work?
Desuden må Venclyxto ikke anvendes sammen med prikbladet perikon (et naturlægemiddel til behandling af angst og depression). 
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).
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Vectormune ND den 8. september 2015. 
The European Commission granted a marketing authorisation valid throughout the EU for Vectormune ND on 8 September 2015.
Der skal dog følges forsigtighedsregler til at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner. 
However, precautionary measures must be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Den fuldstændige EPAR for Vectormune ND findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
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.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vectormune ND. 
This is a summary of the European public assessment report (EPAR) for Vectormune ND.
Sikkerhedsundersøgelser har vist, at stammen er sikker for kalkuner. 
Safety studies have shown that the strain is safe for turkeys.
Hvis dyret efterfølgende udsættes for et tilsvarende virus og/eller et virus, der udtrykker et tilsvarende fusionsprotein, vil immunsystemet reagere hurtigere. 
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.
Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Vectormune ND opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
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. 
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.
Vaccinen beskytter imod en type Mareks sygdomsvirus, der kan forårsage synlig infektion. 
The vaccine protects against a type of Marek disease virus that can cause visible infection.
Der er udført to feltundersøgelser hos omkring 120 000 slagtekyllinger til vurdering af vaccinens virkninger. 
Two field studies were conducted in around 120,000 broiler chickens to evaluate the effects of the vaccine.
Newcastle disease og Mareks sygdom vaccine (levende, rekombinant) 
Newcastle disease and Marek's disease vaccine (live recombinant)
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. 
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.
Yderligere oplysninger fremgår af produktresuméet. 
For further information see the summary of product characteristics.
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. 
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.
Da Vectormune ND er en levende vaccine, udskilles vaccinestammen fra vaccinerede fugle og kan spredes til kalkuner. 
Since Vectormune ND is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Når Vectormune ND gives til kyllinger eller i æg, registrerer dyrenes immunsystem virusset som "fremmed" og reagerer ved at danne antistoffer mod det. 
When Vectormune ND is given to chickens or eggs, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Hvad er Vectormune ND, og hvad anvendes det til? 
What is Vectormune ND and what is it used for?
Andre oplysninger om Vectormune ND 
Other information about Vectormune ND
Der er ingen kendte bivirkninger ved Vectormune ND. 
There are no known side effects with Vectormune ND.
Newcastle disease hos kyllinger er en virussygdom, der forårsager vejrtrækningsbesvær og hoste, symptomer fra nervesystemet (hængende vinger, drejning af hoved og hals, cirkelbevægelser og lammelse), hævelse af vævet omkring øjne og hals, grønlig, vandig diarré og nedsat ægproduktion. 
ND is a viral infection of chickens which causes gasping and coughing, nervous signs (drooping wings, twisting of the head and neck, circling and paralysis), swelling of the tissues around the eyes and neck, greenish watery diarrhoea and reduced egg production.
Hvorfor er Vectormune ND blevet godkendt? 
Why is Vectormune ND approved?
Vaccinen kan gives til daggamle kyllinger som en enkelt injektion under huden eller direkte i 18 dage gamle æg med ikkeudklækkede fostre under udvikling. 
The vaccine can be given to one-day-old chicks as a single injection under the skin or directly into 18-day-old eggs containing embryos (unhatched developing chicks).
Det er ikke en praktisk vejledning i, hvordan Vectormune ND bør anvendes. 
It is not intended to provide practical advice on how to use Vectormune ND.
Kyllingerne bliver inficeret i en tidlig alder ved indånding af skæl fra huden, som indeholder virus og kan forblive smittefarligt i flere måneder efter at være afdrysset fra kroppen. 
Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Hvilke risici er der forbundet med Vectormune ND? 
What are the risks associated with Vectormune ND?
Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vectormune ND, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret. 
Safety information has been included in the summary of product characteristics and the package leaflet for Vectormune ND, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Det aktive stof i Vectormune ND er et kalkunherpesvirus (rHVT/Newcastle Disease), der ikke medfører sygdom hos kyllinger og er blevet modificeret, således at det også producerer et af proteinerne i en Newcastle disease-stamme (lentogen stamme D-26). 
The active substance in Vectormune ND is a turkey herpesvirus (rHVT/ND) that does not cause disease in chickens and has been modified so that it also produces one of the proteins of a strain of Newcastle disease virus (D-26 lentogenic strain).
22 Vectormune ND-vaccinerede daggamle kyllinger til æglægning fra denne undersøgelse blev på dag 21 i laboratoriet belastet med en Newcastle disease-stamme og udviste ingen kliniske tegn i op til to uger efter belastningen, mens alle de 12 uvaccinerede fugle, der blev brugt til sammenligning, døde. 
Twenty-two Vectormune ND vaccinated day-old layer chickens from this study were challenged at day 21 in the laboratory with ND strain and had no clinical signs for up to 2 weeks after challenge while all of 12 unvaccinated birds used for comparison died.
Da der ikke forekom naturlige udbrud af Newcastle disease eller Mareks sygdom, blev kyllingerne belastet (udsat for smitte) i laboratoriet. 
Since no natural outbreaks of ND and MD occurred the chickens were challenged (exposed to infection) in the laboratory.
Vectormune ND er en veterinær vaccine til beskyttelse af kyllinger mod Newcastle disease og Mareks sygdom. 
Vectormune ND is a veterinary vaccine used to protect chickens against Newcastle disease (ND) and Marek's disease (MD).
Beskyttelsen mod Mareks sygdom begynder i alderen én uge og varer i hele risikoperioden for infektion med Mareks sygdom. 
For MD protection starts at one week of age and lasts for the risk period of infection with MD.
Mareks syge hos kyllinger er en herpesvirusinfektion, som kan medføre lammelse af vinger og ben, og som forårsager tumorer i forskellige organer. 
MD is a herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Det modificerede kalkunherpesvirus i Vectormune ND er nært beslægtet med Mareks sygdomsvirus og producerer også det fusionsprotein, der danner den ydre kapsel af Newcastle disease-virus. 
The modified turkey herpesvirus in Vectormune ND is closely related to MD herpesvirus and will also produce the fusion protein which forms part of the outer coat of ND virus.
Vectormune ND fås som en suspension med solvens, hvoraf der fremstilles en suspension til injektion. 
Vectormune ND is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
I en tredje feltundersøgelse blev ca. 10 000 daggamle kyllinger til æglægning vaccineret med Vectormune ND og et tilsvarende antal med en vaccine mod Newcastle disease alene. 
In a third field study around 10,000 one-day-old layer chickens were vaccinated with Vectormune ND and a similar number with a vaccine against ND alone.
Fugle, der er smittet med Mareks sygdomsvirus, kan bære og udskille virussen for livstid. 
Birds infected with MD virus can be carriers and shedders of the virus for life.
I den anden feltundersøgelse blev en gruppe 18 dage gamle æg indeholdende fostre og en gruppe daggamle kyllinger vaccineret med Vectormune ND. 
In the second field study, a group of 18-day-old eggs containing embryos and a group of one-day-old chicks were vaccinated with Vectormune ND.
Beskyttelsen mod Newcastle disease begynder i 3-ugersalderen og varer indtil 9-ugersalderen hos slagtekyllinger og 18-ugersalderen hos kyllinger til æglægning. 
For ND protection starts at 3 weeks of age and lasts until 9 weeks of age for broilers (chickens bred for meat) and 18 weeks of age for layers (chickens bred for egg production).