natgillin/translations-raw huggingface dataset:
Det anvendes til behandling af voksne patienter med følgende former for leukæmi (blodkræft, der udgår fra de hvide blodlegemer): 
It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Hvordan anvendes Iclusig? 
How is Iclusig used?
Undersøgelsen viste, at behandlingen med Iclusig havde klinisk relevant virkning hos alle grupper af patienter: 
The results of the study showed that treatment with Iclusig led to clinically relevant responses in all groups of patients:
I studiet blev Iclusig ikke sammenlignet med nogen anden behandling. 
In the study, Iclusig was not compared with another treatment.
Hvis patienten får visse svære bivirkninger, kan lægen beslutte at nedsætte dosis eller udsætte eller standse behandlingen. 
If a patient develops certain severe side effects, the doctor may decide to reduce subsequent doses or delay or stop treatment.
Iclusig udleveres kun på recept, og behandlingen bør iværksættes af en læge med erfaring i diagnose og behandling af leukæmi. 
Iclusig can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of leukaemia.
Virkningen af behandlingen blev vurderet ved registrering af den andel af patienterne, der opnåede "væsentlig hæmatologisk respons" (dvs. at antallet af hvide blodlegemer bliver normalt igen, eller at der ikke er tegn på leukæmi) eller "væsentlig cytogenetisk respons" (dvs. at andelen af hvide blodlegemer med philadelphiakromosomet falder til under 35 %). 
The response to treatment was assessed by measuring the proportion of patients who had a ‘major haematological response' (when the number of white blood cells returns to normal or there is no evidence of leukaemia) or a ‘major cytogenetic response' (when the proportion of white blood cells containing the Philadelphia chromosome falls to below 35%).
Risikoen for problemer (herunder hjertetilfælde og slagtilfælde) som følge af blodpropper eller blokeringer i arterierne eller venerne kunne nedbringes ved at undersøge for og behandle medvirkende tilstande, såsom højt blodtryk og forhøjet kolesterol, både før og under behandling. 
The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
• kronisk myeloid leukæmi (CML) i stadierne kronisk fase, accelereret fase og blastfase 
• chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
Philadelphiakromosomet findes hos nogle patienter med ALL og hos de fleste patienter med CML. 
The Philadelphia-chromosome is found in some ALL patients and is present in most patients with CML.
Iclusig anvendes hos patienter, der ikke tåler eller ikke reagerer på behandling med dasatinib (patienter med CML eller ALL) eller nilotinib (patienter med CML), som er andre kræftlægemidler i samme gruppe, eller patienter, som ikke er egnede til efterfølgende behandling med imatinib (et tredje sådant lægemiddel). 
Iclusig is used in patients who cannot tolerate or do not respond to dasatinib (patients with CML or ALL) or nilotinib (patients with CML), which are other cancer medicines of the same class, and for whom subsequent treatment with imatinib (a third such medicine) is not considered appropriate.
Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Iclusig fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Iclusig er et kræftlægemiddel, der indeholder det aktive stof ponatinib. 
Iclusig is a cancer medicine that contains the active substance ponatinib.
Hvilke fordele viser studierne, at der er ved Iclusig? 
What benefits of Iclusig have been shown in studies?
Hvad angår sikkerheden, svarer bivirkningerne af Iclusig i det store hele til andre tyrosinkinasehæmmere og kan som regel håndteres ved nedsættelse eller udsættelse af doseringen. 
Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
CHMP bemærkede, at Iclusig var påvist at være effektivt til behandling af de patienter med CML eller Ph+ ALL, for hvem der kun findes begrænsede behandlingsmuligheder. 
Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Venøse tromboemboliske reaktioner (problemer som følge af blodpropper i venerne) forekom hos 6 % af patienterne. 
Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Arterielle okklusive bivirkninger (blodpropper eller blokering i arterierne) forekom hos 25 % af patienterne, og alvorlige bivirkninger hos 20 % af patienterne. 
Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Desuden anvendes det hos patienter, der har genmutationen T315I og derfor ikke reagerer på behandling med imatinib, dasatinib eller nilotinib. 
It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Iclusig er blevet undersøgt i et hovedstudie med 449 patienter, som havde CML eller Ph+ ALL og ikke tålte eller ikke reagerede på behandling med dasatinib eller nilotinib, eller som havde T315Imutationen. 
Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Iclusig kan medføre blodpropper eller blokeringer i arterierne og venerne, og patienternes hjerte og kredsløb skal undersøges både inden og under behandlingen, og eventuelle problemer skal behandles. 
Iclusig can lead to clots or blockages in arteries and veins and patients should have the condition of their heart and circulation considered before starting and during treatment, and be treated appropriately for any problems.
Ponatinib virker ved at blokere tyrosinkinasen Bcr-Abl. 
Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Disse stoffer virker ved at blokere enzymer af typen tyrosinkinase. 
These compounds act by blocking enzymes known as tyrosine kinases.
Det aktive stof i Iclusig, ponatinib, tilhører lægemiddelgruppen "tyrosinkinasehæmmere". 
The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Alvorlige venøse okklusive bivirkninger (blodpropper eller blokering i venerne) forekom hos 5 % af patienterne. 
Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Hvis indholdet af hvide blodlegemer i blodet ikke bliver normalt igen i løbet af tre måneder, bør lægen overveje at standse behandlingen. 
The doctor should consider stopping treatment if the level of white cells in the blood does not return to normal within three months.
• Blandt patienterne med CML i kronisk fase opnåede ca. 54 % (144 ud af 267) væsentlig cytogenetisk respons. 
• among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
Hvordan virker Iclusig? 
How does Iclusig work?
• Blandt patienterne med Ph+ ALL opnåede ca. 41 % (13 ud af 32) væsentlig hæmatologisk respons. 
• among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
• Blandt patienterne med CML i accelereret fase opnåede ca. 58 % (48 ud af 83) væsentlig hæmatologisk respons. 
• among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Iclusig. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Iclusig have also been included in the summary of product characteristics and the package leaflet.
Behandlingen bør afbrydes øjeblikkeligt, hvis der opstår en blokering i en arterie eller vene. 
The dose may need to be reduced or interrupted if the patient experiences certain side effects; it should be interrupted immediately if a blockage develops in an artery or vein.
• Blandt patienterne med CML i blastfase opnåede ca. 31 % (19 ud af 62) væsentlig hæmatologisk respons. 
• among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
CVMP finder på grundlag af alle foreliggende oplysninger ikke anledning til betænkelighed vedrørende produktets sikkerhed eller virkning. 
The CVMP concluded that, based on all available data, there was no concern regarding safety or efficacy for the product.
CVMP anbefaler godkendelse af ændringen af markedsføringstilladelsen. 
The CVMP, therefore, recommended a variation of the Marketing Authorisation.
Det er imidlertid vigtigt at sikre, at godkendelsesgrænserne for styrkeprøven ikke flytter sig i forhold til de oprindelige. 
However, it was important to ensure that the pass limits of the potency test do not drift from the original.
BILAG I 
BACKGROUND INFORMATION
Markedsføringstilladelsen (-tilladelserne) bør ændres med henblik på passende foranstaltninger til mindskelse af variabiliteten ved den serologiske styrketest i mus. 
The Marketing Authorisation(s) should be varied to reduce the variability of the serological potency test in mice by appropriate measures such as the replacement of the use of a reference vaccine in the serological potency test in mice with the use of reference serum.
Lægemiddelform 
European Medicines Agency Veterinary Medicines and Inspections
Ved behandlingen af en type II-ansøgning om ændring af styrkeprøven i mus med henblik på overensstemmelsen med den reviderede Ph.Eur-monografi for erysipelas-vacciner blev batch 8500 godkendt som referencevaccine. 
The referral deals with the issue that in the opinion of France equivalence between the reference vaccine batch for the erysipelas batch potency test validated in the original dossier and the new reference vaccine batches was not shown for these 2 batches and that consequently the CVMP needed to consider whether to vary, withdraw or suspend the marketing authorisation.
De ændringer af referencevaccinen, der indgår i denne indbringelse, vedrører erstatningen af batch 8500 med 9097 og den efterfølgende erstatning af batch 9097 med 9861. 
France notified the EMEA on 11 July 2006 of a Referral under Article 40 of Council Directive 2001/82/EC, as amended, in relation to Suvaxyn Ery.
Den normale dosis er én infusion på 4 mg over mindst 15 minutter. 
The usual dose is one infusion of 4 mg over at least 15 minutes.
Yderligere information vedrørende Zoledronsyre Accord findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord. 
Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Det anbefales ikke til patienter med svært nedsat nyrefunktion. 
It is not recommended for patients with severely reduced kidney function.
Zoledronsyre Accord fik en markedsføringstilladelse med gyldighed i hele EU den 16. januar 2014. 
Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Lægemidlet gives som infusion (drop) i en vene. 
The medicine is given as an infusion (drip) into a vein.
Dette nedsætter knogletabet. 
This reduces bone loss.
Som for alle lægemidler bliver data vedrørende brug af Zoledronsyre Accord løbende overvåget. 
As for all medicines, data on the use of Zoledronic Acid Accord are continuously monitored.
For mere information om brug af Zoledronsyre Accord, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Zoledronic Acid Accord, see the package leaflet or contact your doctor or pharmacist.
Bivirkninger rapporteret for Zoledronsyre Accord vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Zoledronic Acid Accord are carefully evaluated and any necessary action taken to protect patients.
Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Zometa, og de behøver ikke blive gentaget for Zoledronsyre Accord. 
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronsyre Accord er af sammenlignelig kvalitet og er bioækvivalent med Zometa. 
The European Medicines Agency concluded that, in accordance with EU requirements, Zoledronic Acid Accord has been shown to have comparable quality and to be comparable to Zometa.
Det betyder, at Zoledronsyre Accord indeholder samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Zometa. 
This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Zometa, og at det kan godkendes til anvendelse i EU. 
Therefore, the Agency's view was that, as for Zometa, the benefit outweighs the identified risk and it can be authorised for use in the EU.
Da Zoledronsyre Accord er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet. 
Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Der var ikke behov for "bioækvivalensstudier" for at undersøge, om Zoledronsyre Accord optages identisk med referencelægemidlet for at give det samme niveau af det aktive stof i blodet. 
There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Zoledronsyre Accord. 
As for every medicine, the company provided studies on the quality of Zoledronic Acid Accord.
Zoledronsyre Accord udleveres kun efter recept og må kun ordineres og gives af en sundhedsperson, der har erfaring med brugen af denne type lægemiddel, som gives i en vene. 
Zoledronic Acid Accord can only be obtained with a prescription and must only be prescribed and given by a healthcare professional who has experience in the use of this type of medicine given into a vein.
Dette omfatter frakturer (knoglebrud), rygmarvskompression (når rygmarven presses sammen af knoglen), knoglelidelser, der kræver stråleterapi eller operation, og hypercalcæmi (forhøjet calciumindhold i blodet). 
This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Patienter med svulster kan have høje niveauer af calcium, afgivet fra knoglerne, i blodet. 
Patients with tumours can have high levels of calcium in their blood, released from the bones.
Virksomheden, der markedsfører Zoledronsyre Accord, vil udarbejde et kort med information til patienter, som modtager Zoledronsyre Accord, om risikoen for osteonekrose i kæben og med instrukser om at kontakte deres læge, hvis de oplever symptomer. 
The company that markets Zoledronic Acid Accord will provide a card to inform patients receiving Zoledronic Acid Accord about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Ved at forebygge nedbrydningen af knoglerne medvirker Zoledronsyre Accord også til at reducere den mængde calcium, der afgives til blodet. 
By preventing the breakdown of bones, Zoledronic Acid Accord also helps to reduce the amount of calcium released into the blood.
En oversigt over Zoledronsyre Accord, og hvorfor det er godkendt i EU 
An overview of Zoledronic Acid Accord and why it is authorised in the EU
Det skyldes, at Zoledronsyre Accord gives som infusion i en vene, så det aktive stof leveres direkte i blodbanen. 
This is because Zoledronic Acid Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zoledronsyre Accord kan også anvendes til at behandle hypercalcæmi forårsaget af svulster. 
Zoledronic Acid Accord can also be used to treat hypercalcaemia caused by tumours.
Osteonekrose i kæben er en tilstand i kæbebenene, som kan føre til smerter, sår i munden eller løse tænder. 
Osteonecrosis of the jaw is a condition affecting the bones of the jaw, which could lead to pain, sores in the mouth or loose teeth.
Zoledronsyre Accord er et lægemiddel til forebyggelse af knoglekomplikationer hos voksne med fremskreden kræft, der påvirker knoglerne. 
Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Zoledronsyre Accord indeholder det aktive stof zoledronsyre og er et "generisk lægemiddel". 
Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Det aktive stof i Zoledronsyre Accord, zoledronsyre, er et bisphosphonat. 
The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronsyre Accord? 
What measures are being taken to ensure the safe and effective use of Zoledronic Acid Accord?
Andre oplysninger om Zoledronsyre Accord 
Other information about Zoledronic Acid Accord
Hvilke fordele og risici er der forbundet med Zoledronsyre Accord? 
What are the benefits and risks of Zoledronic Acid Accord?
Hvad er Zoledronsyre Accord, og hvad anvendes det til? 
What is Zoledronic Acid Accord and what is it used for?
Zoledronsyre Accord (zoledronsyre) 
Zoledronic Acid Accord (zoledronic acid)
Hvorfor blev Zoledronsyre Accord godkendt i EU? 
Why is Zoledronic Acid Accord authorised in the EU?
Nedsættelsen af knogletabet mindsker risikoen for knoglebrud, hvilket er til gavn for kræftpatienter med knoglemetastaser. 
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Til forebyggelse af knoglekomplikationer kan infusionen gentages hver tredje til fjerde uge, og patienterne bør desuden tage calcium- og D-vitamintilskud. 
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zoledronsyre Accord. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zoledronic Acid Accord have also been included in the summary of product characteristics and the package leaflet.
Hvordan blev Zoledronsyre Accord undersøgt? 
How has Zoledronic Acid Accord been studied?
Hvordan virker Zoledronsyre Accord? 
How does Zoledronic Acid Accord work?
Hvordan anvendes Zoledronsyre Accord? 
How is Zoledronic Acid Accord used?
Dette er med til at beskytte mod sygdommen. 
This will help protect against the disease.
Dette sammendrag blev sidst ajourført i juni 2017. 
This summary was last updated in June 2017.
Den fuldstændige EPAR for Vepured findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
The full EPAR for Vepured can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Beskyttelsen indtræder 21 dage efter vaccinationen og varer i 112 dage. 
Protection starts 21 days after vaccination and lasts for 112 days.
Hvad er Vepured, og hvad anvendes det til? 
What is Vepured and what is it used for?
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vepured. 
This is a summary of the European public assessment report (EPAR) for Vepured.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vepured den 17/08/2017. 
The European Commission granted a marketing authorisation valid throughout the EU for Vepured on 17 August 2017.
Tilbageholdelsestiden for kød fra svin, der behandles med Vepured, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid. 
The withdrawal period for meat from pigs treated with Vepured is ‘zero' days, which means there is no mandatory waiting time.
Vepured reducerede også vægttabet hos svin i besætninger, der var ramt af sygdommen. 
Vepured also reduced the weight loss of pigs in herds affected with the disease.
Det medfører skader på blodkarrene, forårsager væskeophobning i mave- og tarmvævet, påvirker blodforsyningen til hjernen og kan medføre død inden for 24-48 timer. 
It results in damage to blood vessels, causing fluid build up in the tissues of the stomach and bowel and affecting the blood supply of the brain, and can lead to death within 24 to 48 hours.
Det er ikke en praktisk vejledning i, hvordan Vepured bør anvendes. 
It is not intended to provide practical advice on how to use Vepured.
Hvorfor blev Vepured godkendt? 
Why is Vepured approved?
Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Vepured opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Vepured's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvilke risici er der forbundet med Vepured? 
What are the risks associated with Vepured?
Andre oplysninger om Vepured 
Other information about Vepured:
Hvis dyrene efterfølgende udsættes for den bakterie, der danner det umodificerede toksin, vil deres immunsystem hurtigere kunne danne antistoffer mod toksinet. 
In the future, if the animals are exposed to the bacteria producing the unmodified toxin, their immune system will be able to make antibodies against the toxin more quickly.
Vepured indeholder adjuvanser (aluminiumhydroxid og DEAE-dextran), der forstærker immunresponsen. 
Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
De hyppigste bivirkninger ved Vepured (som kan optræde hos mere end 1 ud af 10 dyr) er let inflammation på injektionsstedet, som forsvinder uden behandling i løbet af tre dage efter vaccinationen, let nedstemthed på vaccinationsdagen og en stigning i kropstemperaturen på højst 1,1 °C, som forsvinder i løbet af en dag. 
The most common side effects with Vepured (which may affect more than 1 in 10 animals) are mild inflammation at the injection site that resolves within 3 days of vaccination without treatment, mild depression on the day of vaccination and an increase in body temperature of maximum 1.1 °C which returns to normal within 1 day.
Vepured indeholder verotoksin 2e, som er blevet modificeret og inaktiveret, så det ikke længere kan forårsage sygdom. 
Vepured contains verotoxin 2e that has been modified and inactivated so it can no longer cause disease.
Ødemsyge findes i hele verden og forekommer som regel i smågrisenes første leveuger. 
Oedema disease is found worldwide and usually occurs in the first few weeks of life of the piglets.