FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the condition it is used to treat, Rixathon may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Danish: Alt efter hvilken sygdom Rixathon anvendes til, kan det gives alene eller sammen med kemoterapi (andre kræftlægemidler) eller med lægemidler mod inflammatoriske sygdomme (methotrexat eller et binyrebarkhormon).
English: How is Rixathon used?
Danish: Hvordan anvendes Rixathon?
English: • pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.
Danish: • en alvorlig tilstand med udbredt blæredannelse på hud og slimhinder i munden, næsen, svælget og kønsorganerne (pemphigus vulgaris).
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Danish: • to forskellige typer blodkræft af typen non-Hodgkin-lymfom (follikulært lymfom og diffust storcellet
English: What benefits of Rixathon have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rixathon?
English: In addition, a study in patients with follicular lymphoma has shown that the safety and effectiveness of Rixathon are equivalent to those of MabThera.
Danish: Derudover har et studie af patienter med follikulært lymfom vist, at Rixathon svarer til MabThera, hvad angår sikkerhed og virkning.
English: A supportive study in patients with rheumatoid arthritis also indicated similar effectiveness between MabThera and Rixathon.
Danish: Et understøttende studie hos patienter med leddegigt har også vist, at MabThera og Rixathon er lige effektive.
English: • chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
Danish: • en anden type blodkræft, som påvirker de hvide blodlegemer (kronisk lymfatisk leukæmi (CLL))
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rixathon have also been included in the summary of product characteristics and the package leaflet.
Danish: 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 Rixathon.
English: How does Rixathon work?
Danish: Hvordan virker Rixathon?
English: • severe rheumatoid arthritis (an inflammatory condition of the joints);
Danish: • svær leddegigt (reumatoid arthritis)
English: This summary was last updated in 12-2016.
Danish: Dette sammendrag blev sidst ajourført i 12-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suliqua on 11 January 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suliqua den 11. januar 2017.
English: This is a summary of the European public assessment report (EPAR) for Suliqua.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Suliqua.
English: The full EPAR for Suliqua can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Suliqua findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Suliqua
Danish: Andre oplysninger om Suliqua
English: What measures are being taken to ensure the safe and effective use of Suliqua?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Suliqua?
English: A reduction in HbA1c levels means an improvement in the control of blood sugar levels.
Danish: Et fald i indholdet af HbA1c er ensbetydende med en forbedring i reguleringen af blodsukkeret.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Suliqua's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Suliqua opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The dose is adjusted individually for each patient, and the patient's blood glucose should be regularly tested to find the lowest effective dose.
Danish: Dosis tilpasses den enkelte patient, og blodsukkeret skal kontrolleres regelmæssigt for at fastlægge den laveste effektive dosis.
English: It is not intended to provide practical advice on how to use Suliqua.
Danish: Det er ikke en praktisk vejledning i, hvordan Suliqua bør anvendes.
English: Suliqua is a medicine that is used together with metformin (another diabetes medicine) for the treatment of adults with type 2 diabetes.
Danish: Suliqua er et lægemiddel, der anvendes sammen med metformin (et andet lægemiddel mod sukkersyge) til behandling af voksne med type 2-sukkersyge.
English: Why is Suliqua approved?
Danish: Hvorfor er Suliqua blevet godkendt?
English: Suliqua insulin glargine / lixisenatide
Danish: Suliqua insulin glargin/lixisenatid
English: Suliqua has been shown to be effective at controlling blood glucose in two main studies involving 1,906 patients with type 2 diabetes.
Danish: Suliqua er påvist at have gavnlig virkning på reguleringen af blodsukkeret i to hovedundersøgelser hos 1 906 patienter med type 2-sukkersyge.
English: What are the risks associated with Suliqua?
Danish: Hvilke risici er der forbundet med Suliqua?
English: By controlling the level of blood glucose, the symptoms of diabetes are reduced and complications are avoided.
Danish: Når blodsukkeret reguleres, mindskes sukkersygesymptomerne, og komplikationer undgås.
English: What is Suliqua and what is it used for?
Danish: Hvad er Suliqua, og hvad anvendes det til?
English: Suliqua is available as pre-filled disposable pens in two different strengths and can only be obtained with a prescription.
Danish: Suliqua leveres som fyldte penne til engangsbrug i to forskellige styrker og udleveres kun efter recept.
English: Average HbA1c was 8.1% before patients started taking Suliqua or insulin glargine.
Danish: Det gennemsnitlige indhold af HbA1c var 8,1 %, før patienterne begyndte at tage Suliqua eller insulin glargin.
English: The company that markets Suliqua will provide educational materials for healthcare professionals and patients, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Danish: Den virksomhed, der markedsfører Suliqua, vil udlevere oplysningsmateriale til sundhedspersoner og patienter med instruktioner i sikker anvendelse af lægemidlet, for at nedsætte risikoen for fejlbehandling.
English: The CHMP concluded that combination treatments with a long-acting insulin and a GLP-1 agonist such as Suliqua are an important treatment option for patients who are eligible for insulin or who need intensive insulin therapy.
Danish: CHMP konkluderede, at kombinationsbehandling med langtidsvirkende insulin og en GLP-1-agonist såsom Suliqua er en vigtig behandlingsmulighed for patienter, som er egnede til insulinbehandling, eller som behøver intensiv insulinbehandling.
English: It acts in the same way as GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases in response to food.
Danish: Det virker på samme måde som GLP-1 (et hormon, der produceres i tarmen) ved at få bugspytkirtlen til at afgive mere insulin som reaktion på fødeindtagelse.
English: For more information about treatment with Suliqua, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Suliqua, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In both studies, the main measure of effectiveness was the change after 30 weeks of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: I begge undersøgelser var det vigtigste mål for virkningen efter 30 ugers behandling ændringen i blodets indhold af stoffet glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodsukkeret er reguleret.
English: Type 2 diabetes is a disease in which the level of blood glucose is high because either the body does not produce enough insulin or the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge er blodsukkeret højt, fordi kroppen enten ikke producerer nok insulin eller ikke er i stand til at udnytte insulinet effektivt.
English: It is used when blood glucose (sugar) levels are not satisfactorily controlled by metformin alone or by a combination of metformin and another medicine (either another glucose-lowering medicine taken by mouth or a long-acting insulin).
Danish: Det anvendes, når indholdet af glukose (sukker) i blodet ikke er tilfredsstillende reguleret med metformin alene eller med en kombination af metformin og et andet lægemiddel (enten et andet glukosesænkende lægemiddel taget gennem munden eller et langtidsvirkende insulin).
English: One of the active substances in Suliqua, insulin glargine, is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood, thereby controlling the level of glucose in the blood.
Danish: Det ene aktive stof i Suliqua, insulin glargin, er et erstatningsinsulin, der virker på samme måde som kroppens eget insulin og medvirker til, at glukose trænger ind i cellerne fra blodet, hvorved det regulerer indholdet af glukose i blodet.
English: Results showed that Suliqua is more effective at controlling blood glucose levels than either components: average HbA1c at the start of the study was 8.1%, which fell after 30 weeks of treatment to 6.5% in the group using Suliqua, compared with 6.8% in the group using insulin glargine and 7.3% in the group using lixisenatide.
Danish: Resultaterne viste, at Suliqua er mere effektivt til at regulere blodsukkeret end nogen af dets to bestanddele: Det gennemsnitlige indhold af HbA1c var ved undersøgelsens start 8,1 %, som efter 30-ugers behandling faldt til 6,5 % i den gruppe, der brugte Suliqua, sammenholdt med 6,8 % i den gruppe, der brugte insulin glargin, og 7,3 % i den gruppe, der brugte lixisenatid.
English: In terms of safety there were no new safety concerns with the combination of insulin glargine and lixisenatide in Suliqua compared with the components used separately.
Danish: Hvad sikkerheden angik, var der ingen nye sikkerhedsproblemer med kombinationen af insulin glargin og lixisenatid i Suliqua i forhold til hver bestanddel for sig.
English: In these patients, Suliqua was effective at controlling glucose levels and reduced the risk of problems linked to intensive insulin therapy such as hypoglycaemia and weight gain.
Danish: Hos disse patienter var Suliqua effektivt til at regulere blodsukkeret og mindskede risikoen for problemer knyttet til intensiv insulinbehandling såsom hypoglykæmi og vægtøgning.
English: After 30 weeks of treatment average HbA1c fell to 6.9% in the group taking Suliqua and to 7.5% in patients receiving insulin glargine.
Danish: Efter 30 ugers behandling faldt det gennemsnitlige indhold af HbA1c til 6,9 % hos den gruppe, der tog Suliqua, og til 7,5 % hos de patienter, der fik insulin glargin.
English: Patients who entered the study, had to stop all medicines given by mouth except metformin and were then given either Suliqua or insulin glargine.
Danish: Patienter, der deltog i undersøgelsen, skulle stoppe med alle lægemidler indtaget gennem munden undtagen metformin og fik derefter enten Suliqua eller insulin glargin.
English: The active substances in Suliqua are insulin glargine and lixisenatide.
Danish: De aktive stoffer i Suliqua er insulin glargin og lixisenatid.
English: For the full list of all side effects and restrictions with Suliqua, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Suliqua fremgår af indlægssedlen.
English: The other active substance in Suliqua, lixisenatide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Danish: Det andet aktive stof i Suliqua, lixisenatid, tilhører en gruppe sukkersygelægemidler, der betegnes GLP1-agonister.
English: The first study involved 1,170 patients whose blood glucose was not adequately controlled by metformin with or without another diabetes medicine taken by mouth.
Danish: Den første undersøgelse omfattede 1 170 patienter, hvis blodsukker ikke var tilfredsstillende reguleret med metformin med eller uden et andet sukkersygelægemiddel indtaget gennem munden.
English: The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth.
Danish: Den anden undersøgelse omfattede 736 patienter, hvis blodsukker ikke var tilfredsstillende reguleret med et langtidsvirkende insulin såsom insulin glargin med eller uden et eller to andre sukkersygelægemidler indtaget gennem munden.
English: For practical information about using Suliqua, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Suliqua, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Upon entering the study, all patients had to stop their other diabetes medicines and were given Suliqua or insulin glargine or lixisenatide, all with metformin.
Danish: Alle patienter skulle ved undersøgelsens start stoppe med deres andre sukkersygelægemidler og fik Suliqua eller insulin glargin eller lixisenatid, alle med metformin.
English: Before Suliqua is started the patient's insulin and diabetes medicines other than metformin must be stopped.
Danish: Før behandlingen med Suliqua indledes skal patienten ophøre med insulin og sukkersygelægemidler bortset fra metformin.
English: How is Suliqua used?
Danish: Hvordan anvendes Suliqua?
English: What benefits of Suliqua have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Suliqua?
English: Insulin glargine enters the bloodstream more slowly than human insulin after an injection and its action is therefore longer lasting.
Danish: Efter en indsprøjtning trænger insulin glargin langsommere ind i blodet end kroppens eget insulin og virker derfor længere.
English: It is given as an injection under the skin of the belly, the thigh or the upper arm. Suliqua is given once a day, preferably at the same time each day.
Danish: Suliqua gives én gang dagligt, helst på samme tidspunkt hver dag.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Suliqua have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge med henblik på sikker og effektiv anvendelse af Suliqua.
English: The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Suliqua (som optræder hos mere end 1 ud af 10 patienter) er hypoglykæmi (lavt blodsukker).
English: How does Suliqua work?
Danish: Hvordan virker Suliqua?
English: 6 bottles Not applicable
Danish: Til inhalation Flaske (glas) 250 ml 6 flasker
English: 1 bottle Not applicable
Danish: Til inhalation Flaske (glas) 250 ml 1 flaske
English: It must also not be used in a pregnant woman.
Danish: Det må heller ikke anvendes hos gravide kvinder.
English: ProQuad is a vaccine.
Danish: ProQuad er en vaccine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ProQuad den 6. april 2006.
English: It must not be used in children who have severely weakened immune systems.
Danish: Det må ikke anvendes til børn, som har et alvorligt svækket immunsystem.
English: The full EPAR for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for ProQuad findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This will help to protect against the diseases caused by these viruses.
Danish: Dette er med til at beskytte mod de sygdomme, som kan forårsages af disse vira.
English: Another study also looked at the responses one year after vaccination in 2,108 children.
Danish: I en anden undersøgelse blev der også fokuseret på reaktionerne et år efter vaccination af 2 108 børn.
English: This is a summary of the European public assessment report (EPAR) for ProQuad.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ProQuad.
English: Because ProQuad contains well known weakened viruses, which are already used in other vaccines, the company presented data from vaccines that are already on the market.
Danish: Fordi ProQuad indeholder velkendte, svækkede vira, der allerede bruges i andre vacciner, fremlagde virksomheden data fra vacciner, som allerede findes på markedet.
English: ProQuad is used according to official recommendations, including the number of doses and the interval between them.
Danish: ProQuad anvendes i overensstemmelse med de officielle anbefalinger, herunder antallet af doser og intervallet mellem disse.
English: This study looked at the ability of the vaccine to trigger immune responses in these age groups.
Danish: I undersøgelsen blev der set på vaccinens evne til at fremkalde en immunrespons hos disse aldersgrupper.
English: The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months).
Danish: Hovedundersøgelserne blev udført for at undersøge, med hvilken effekt én eller to doser af vaccinen fremkalder immunrespons hos 5 446 raske børn (i alderen 12 til 23 måneder).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ProQuad.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for ProQuad.
English: Other information about ProQuad
Danish: Andre oplysninger om ProQuad
English: For more information about treatment with ProQuad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med ProQuad, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is only given under the skin in patients with low levels of platelets in the blood or other bleeding disorders, as they may experience bleeding if the vaccine is injected into a muscle.
Danish: Det gives kun under huden til patienter med et lavt indhold af blodplader i blodet eller andre blødningsforstyrrelser, da disse personer kan opleve blødninger, hvis vaccinen gives som injektion i en muskel.
English: A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later.
Danish: Der er også gennemført en undersøgelse med ProQuad hos 1 620 børn, som fik den første dosis i alderen 9, 11 og 12 måneder og anden dosis tre måneder senere.
English: The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection.
Danish: De hyppigste bivirkninger ved ProQuad (som optræder hos flere end 1 ud af 10 patienter) er feber og smerte og erytem (rødme) på injektionsstedet.
English: The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults.
Danish: Vaccinen gives som injektion i en muskel under huden, helst i lårmusklen på små børn og i skulderområdet på ældre børn og voksne.
English: The active substances are attenuated (weakened) viruses for the diseases.
Danish: De aktive stoffer er svækkede vira svarende til de pågældende sygdomme.
English: When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes defences against them.
Danish: Når vaccinen gives, opfatter immunsystemet de svækkede vira som ‘fremmede' og danner antistoffer mod dem.
English: In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again.
Danish: Når immunsystemet efterfølgende udsættes for disse vira igen, vil det være i stand til at reagere hurtigere mod dem.
English: Children between nine and 12 months of age should receive a second dose at least three months after the first dose to ensure that they are adequately protected against measles and chickenpox.
Danish: Børn mellem ni og 12 måneder skal have endnu en dosis mindst tre måneder efter den første for at sikre, at de er tilstrækkeligt beskyttet mod mæslinger og skoldkopper.
English: After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.
Danish: Efter den anden dosis var frekvenserne ca. 99 % for mæslinger, 100 % for fåresyge, 98 % for røde hunde og 99 % for skoldkopper.
English: However, children who received the first dose at nine months of age had a lower immune response against measles.
Danish: Hos børn, der fik den første dosis i ni måneders alderen, var immunresponsen mod mæslinger dog lavere.
English: ProQuad is available as a powder and solvent that are made up into a suspension for injection.
Danish: ProQuad fås som et pulver og en solvens, der blandes til en injektionsvæske, opløsning.
English: The Committee also recommended that the vaccine be authorised in children from nine to 12 months of age only in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Danish: Udvalget anbefalede endvidere, at vaccinen også kan gives til børn fra ni til 12-måneders alderen i visse situationer, f.eks. som led i et nationalt vaccinationsprogram, under et sygdomsudbrud eller ved rejse til en region, hvor mæslinger er en almindelig sygdom.
English: The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox.
Danish: Der opnåedes følgende responsrater hos børn over 12 måneder (et mål for, i hvilket omfang immunsystemet har reageret på de pågældende vira): 98 % for mæslinger, 96 % til 99 % for fåresyge, 96 % for røde hunde og 91 % for skoldkopper.
English: The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age.
Danish: Undersøgelsen hos børn fra ni til 12 måneder viste, at immunresponsen efter to doser af ProQuad mod fåresyge, røde hunde og skoldkopper hos børn, der modtog den første dosis i ni måneders alderen, var sammenlignelig med responsen hos dem, der fik den første dosis i 12-måneders alderen.