FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP's view was that, as for MabThera, the benefits of Truxima outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Truxima opvejer de identificerede risici som for MabThera, og at det kan godkendes til anvendelse i EU.
English: How is Truxima used?
Danish: Hvordan anvendes Truxima?
English: When rituximab attaches to CD20, it causes the death of B lymphocytes, which helps in lymphoma and CLL (where B-lymphocytes have become cancerous) and in rheumatoid arthritis (where B lymphocytes are involved in joint inflammation).
Danish: Dette hjælper ved lymfom og CLL (hvor B-lymfocytter er blevet til kræftceller) og ved rheumatoid arthritis (hvor B-lymfocytter medvirker til betændelse i leddene).
English: For the full list of side effects of Truxima, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Truxima fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truxima 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 Truxima.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in the majority of patients after the first infusion.
Danish: De hyppigste bivirkninger forbundet med rituximab er reaktioner knyttet til infusionen (såsom feber og kulderystelser).
English: The active substance in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B lymphocytes (types of white blood cells).
Danish: Det er opbygget, så det genkender og binder sig til proteinet CD20, der findes på overfladen af hvide blodlegemer af typen B-lymfocytter.
English: The company marketing Truxima will provide doctors and patients using the medicine for non-cancer conditions with educational material on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Danish: Af materialet vil det fremgår, at lægemidlet skal gives på et sted, hvor der er genoplivningsudstyr for hånden, og at der er risiko for infektion, herunder PML.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Budesonide/Formoterol Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva on 19 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Budesonide/Formoterol Teva den 19. november 2014.
English: Budesonide/Formoterol Teva is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Danish: Budesonide/Formoterol Teva anvendes desuden til dæmpe symptomerne på svær kronisk obstruktiv lungesygdom (KOL) hos voksne, der tidligere har haft anfald med forværring af sygdommen trods regelmæssig behandling.
English: The two active substances in Budesonide/Formoterol Teva are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Danish: De to aktive stoffer i Budesonide/Formoterol Teva er velkendte og findes i flere lægemidler, der anvendes til behandling af astma og KOL, enten alene eller i kombination med andre lægemidler.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Danish: Det kan dels anvendes hos patienter, hvis sygdom ikke kan kontrolleres tilfredsstillende ved inhalation af andre astmalægemidler af typen binyrebarkhormoner og “korttidsvirkende beta-2stimulerende midler”, og dels hos patienter, hvis sygdom kan kontrolleres tilfredsstillende ved inhalation af binyrebarkhormoner og “langtidsvirkende beta-2-stimulerende midler”.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Budesonide/Formoterol Teva.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det er påvist, at Budesonide/Formoterol Teva, 160/4,5 µg og 320/9 µg, har en kvalitet som Symbicort Turbohaler og en virkning som de tilsvarende styrker af Symbicort Turbohaler.
English: The benefits and risks of Budesonide/Formoterol Teva are therefore taken to be the same as those of the reference medicine.
Danish: Fordelene og risiciene ved Budesonide/Formoterol Teva antages derfor at være de samme som med referencelægemidlet
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva is given using a different inhaler.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder de samme aktive stoffer, men til Budesonide/Formoterol Teva anvendes en anden inhalator.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cells.
Danish: Det virker ligesom naturligt binyrebarkhormon, idet det dæmper immunsystemets aktivitet ved at bindes til receptorer i forskellige typer immunceller.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Budesonide/Formoterol Teva anvendes så sikkert som muligt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Budesonide/Formoterol Teva, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Budesonide/Formoterol Teva can be used for the regular treatment of asthma.
Danish: Budesonide/Formoterol Teva kan anvendes til regelmæssig behandling af astma.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles.
Danish: Det virker ved at bindes til beta-2receptorerne i muskulaturen.
English: The reference medicine for Budesonide/Formoterol Teva is Symbicort Turbohaler.
Danish: Referencelægemidlet for Budesonide/Formoterol Teva er Symbicort Turbohaler.
English: Studies were carried out to show that Budesonide/Formoterol Teva is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Danish: Der er udført undersøgelser, der viser, at Budesonide/Formoterol Teva frembringer samme mængde aktivt stof i kroppen som referencelægemidlet (dvs. det er bioækvivalent med referencelægemidlet), og at de to lægemidler virker på samme måde.
English: Budesonide/Formoterol Teva budesonide / formoterol
Danish: Budesonide/Formoterol Teva budesonid / formoterol
English: When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Ved inhalation bindes det hovedsageligt til disse receptorer i luftvejene og afslapper musklerne, så luftvejene holdes frie, og patienten bedre kan trække vejret.
English: For more information about treatment with Budesonide/Formoterol Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Budesonide/Formoterol Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Budesonide/Formoterol Teva?
English: Other information about Budesonide/Formoterol Teva
Danish: Andre oplysninger om Budesonide/Formoterol Teva
English: Budesonide/Formoterol Teva is a medicine that contains the active substances budesonide and formoterol.
Danish: Budesonide/Formoterol Teva er et lægemiddel, der indeholder de to aktive stoffer budesonid og formoterol.
English: Budesonide/Formoterol Teva is a ‘hybrid medicine'.
Danish: Budesonide/Formoterol Teva er et “hybridt lægemiddel”.
English: What are the benefits and risks of Budesonide/Formoterol Teva?
Danish: Hvilke fordele og risici er der forbundet med Budesonide/Formoterol Teva?
English: What is Budesonide/Formoterol Teva and what is it used for?
Danish: Hvad er Budesonide/Formoterol Teva, og hvad anvendes det til?
English: Why is Budesonide/Formoterol Teva approved?
Danish: Hvorfor er Budesonide/Formoterol Teva blevet godkendt?
English: It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva.
Danish: Det er ikke en praktisk vejledning i, hvordan Budesonide/Formoterol Teva bør anvendes.
English: For practical information about using Budesonide/Formoterol Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Budesonide/Formoterol Teva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The Committee recommended that Budesonide/Formoterol Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Budesonide/Formoterol Teva.
English: How is Budesonide/Formoterol Teva used?
Danish: Hvordan anvendes Budesonide/Formoterol Teva?
English: How does Budesonide/Formoterol Teva work?
Danish: Hvordan virker Budesonide/Formoterol Teva?
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
Danish: PRODUKTRESUME (SmPC)
English: • “If required, appropriate symptomatic treatment should be given in specialized care unit”.
Danish: • “Om nødvendigt skal relevant symptomatisk behandling gives på en specialafdeling”.
English: There are no or limited amount of data from the use of {Active substance} in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ”den aktive substans” til gravide kvinder.
English: Section 5.1 • “Terpenic derivatives may lower the epileptogenous threshold.”
Danish: Afsnit 5.1 • “Terpenholdige derivater kan sænke tærsklen for epileptiske anfald”
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: ÆNDRINGER, DER SKAL INKLUDERES I RELEVANTE AFSNIT AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: Section 4.9 • “Repeated and prolonged use may cause rectal burning.”
Danish: Afsnit 4.9 • “Gentagen og langvarigt brug kan udløse en brændende fornemmelse ved rektum.”
English: There is insufficient information on the excretion of {Active substance} in human milk.
Danish: Data for udskillelse af ”den aktive substans” i human mælk er utilstrækkelige.
English: Section 4.2 • {(Invented) Name} is contraindicated in children less than 30 months (see section 4.3).
Danish: Afsnit 4.2 • ”Særnavn” er kontraindiceret til børn under 30 måneder (se pkt.
English: Section 4.3 “Hypersensitivity to the active substances or to any of the excipients” “Children less than 30 months” “Children with a history of epilepsy or febrile convulsion” “Recent history of anorectal lesion”
Danish: Afsnit 4.3 - “Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne” - “Børn under 30 måneder” - “Børn med epilepsi eller feberkramper i anamnesen” - “Nyligt tilfælde af anorektal læsion”
English: • “As this product is inflammable, do not go near a flame.”
Danish: • “Da dette produkt er brandfarligt, skal det holdes væk fra åben ild.”
English: • “Do not administer at a dose higher than recommended due to an increased risk of adverse drug reactions and disorders related to overdosage (see section 4.9).”
Danish: • “Ordiner ikke en højere dosis end anbefalet på grund af øget risiko for bivirkninger og gener relateret til overdosering (se afsnit 4.9).”
English: • “In case of accidental oral intake or administration error in infants and children, there is a risk of neurological disorders.”
Danish: • “I tilfælde af utilsigtet oral indtagelse eller fejladministration hos spædbørn og børn er der risiko for neurologiske lidelser.”
English: • “Do not prolong the treatment over 3 days due to the risks related to terpenic derivatives storage (because of their lipophilic properties, the rate of metabolism and elimination is unknown) in tissues and brain, in particular neuropsychological disorders; and the risk of rectal burning.”
Danish: • “Forlæng ikke behandlingen ud over 3 dage på grund af risici relateret til ophobning af terpenholdige derivater (på grund af deres lipofile egenskaber er metaboliserings- og eliminationshastigheden ukendt) i væv og hjerne, især ved neuropsykologiske lidelser; og på grund af risikoen for en brændende fornemmelse ved rectum.
English: • “This product contains terpenic derivatives which, at excessive dose, may cause neurological disorders as convulsions in infants and children.”
Danish: • “Dette lægemiddel indeholder terpenholdige derivater, der ved overdosering kan forårsage neurologiske lidelser som kramper hos spædbørn og børn .”
English: • “Do not use concomitantly with other products (medicinal or cosmetic) containing terpenic derivatives whatever the route of administration (oral, rectal, cutaneous, or pulmonary).”
Danish: • “Må ikke anvendes sammen med andre produkter (lægemidler eller kosmetik), der indeholder terpenholdige derivater uanset indgivelsesmåde (oral, rektal, kutan eller ved inhalation)”
English: • Removal of posology related to children less than 30 months.
Danish: Afsnit 1 • Fjernelse af dosering relateret til børn under 30 måneder.
English: • “Do not use in children less than 30 months”
Danish: Afsnit 15 • “Må ikke anvendes til børn under 30 måneder”
English: {(Invented) Name} is not recommended during pregnancy <and in women of childbearing potential not using contraception.>
Danish: ”Særnavn” bør ikke anvendes under graviditet eller til kvinder i den fertile alder, som ikke anvender prævention.
English: {(Invented) Name} should not be used during breast-feeding.
Danish: ”Særnavn” bør ikke anvendes under amning.
English: • “Due to the presence of <name(s) of terpenic derivative(s)> and in case of non-adherence to the recommended doses, there is a risk of convulsions in children and infants”
Danish: • “På grund af indhold af <navn på terpenholdig(e) derivat(er)> og i tilfælde af manglende overholdelse af de anbefalede doser, er der risiko for kramper hos børn og spædbørn”
English: - Do not prolong the treatment over 3 days due to the possible risks related to the accumulation of terpenic derivatives (for example camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) in the body including the brain, in particular neuropsychological disorders; and the risk of rectal burning.” - “Do not administer at doses higher than recommended due to an increased risk of adverse drug reactions and overdosage related disorders.” - “As this product is inflammable, do not go near a flame.” “Pregnancy and breast-feeding: - Do not use during pregnancy or breast-feeding”
Danish: - Forlæng ikke behandlingen ud over 3 dage på grund af risici i forbindelse med ophobning af terpenholdige derivater (for eksempel kamfer, cineol, niaouli, vild timian, terpinol, terpin, citral, mentol og essentielle fyrrenåleolier, eukalyptus og terpentin) i kroppen, herunder også i hjernen - især ved neuropsykologiske lidelser og på grund af risikoen for en brændende fornemmelse ved endetarmen.
English: The following wording should be included in the labelling of the marketing authorisations to be varied, as relevant:
Danish: Følgende ordlyd skal medtages i etiketteringen for de markedsføringstilladelser, der skal ændres, hvis det er relevant
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Danish: Følgende ordlyd skal medtages i indlægssedlen for de markedsføringstilladelser, der skal ændres, hvis det er relevant:
English: “Use with other medicines - Do not use {(Invented) Name} while also taking other products (medicinal or cosmetic) containing terpenic derivatives (for example camphor, cineole, niaouli, wild thyme, terpineol,
Danish: Brug ikke ”Særnavn” sammen med andre produkter (lægemidler eller kosmetik), der indeholder terpenholdige derivater (for eksempel kamfer, cineol, niaouli, vild timian, terpinol, terpin, citral, mentol og essentielle fyrrenåleolier, eukalyptus og terpentin) uanset indgivelsesmåde (via munden, endetarmen, på huden eller ved inhalation)”
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Danish: Indehaverne af markedsføringstilladelse udpeger en nærmere bestemt patientpopulation, for hvem produktets fordele opvejer risikoen.
English: Conditions for the lifting of the suspension of the Marketing Authorisations
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten/-staterne eller i givet fald i referencemedlemsstaten/-staterne sikrer, at indehaveren/indehaverne af markedsføringstilladelse opfylder følgende betingelser:
English: Annex IV Conditions for the lifting of the marketing authorisation
Danish: Bilag IV Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: • women who are pregnant;
Danish: • - kvinder, der er gravide
English: However, it withdrew this application during the initial assessment of the medicine.
Danish: Virksomheden trak dog denne anvendelse tilbage under den indledende vurdering af lægemidlet.
English: Thalidomide Celgene received a marketing authorisation valid throughout the EU on 16 April 2008.
Danish: Thalidomide Celgene fik en markedsføringstilladelse med gyldighed i hele EU den 16. april 2008.
English: • patients who are unable to follow or to comply with the requirement to use contraceptives.
Danish: • - patienter, der ikke er i stand til at følge eller overholde kravet om anvendelse af prævention.
English: • women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;
Danish: • - kvinder, der kan blive gravide, medmindre de træffer alle de nødvendige forholdsregler for at sikre, at de ikke er gravide før behandlingen, og at de ikke bliver gravide under eller kort tid efter behandlingen
English: The recommended dose is 200 mg (4 capsules) a day, taken at the same time, preferably at bedtime.
Danish: Den anbefalede dosis er 200 mg (fire kapsler) pr. dag taget på samme tid og helst ved sengetid.
English: The company will also collect information on whether the medicine is used outside its approved indication.
Danish: Virksomheden vil endvidere indsamle oplysninger om, hvorvidt lægemidlet anvendes til anden behandling end den godkendte indikation.
English: The doctor may delay, reduce or stop doses if the patient gets certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Danish: Lægen kan forsinke, reducere eller stoppe doseringen, hvis patienten får visse bivirkninger, herunder blodpropper, nerveskade, udslæt, lav hjerterytme, besvimelse eller søvnighed.
English: In patients over 75 years of age a starting dose of 100 mg (2 capsules) a day is recommended.
Danish: Til patienter over 75 år er den anbefalede startdosis 100 mg (to kapsler) pr. dag.
English: The company that markets Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Danish: Virksomheden, der markedsfører Thalidomide Celgene, vil oprette et graviditetsforebyggende program i hver medlemsstat.
English: This can help to slow down the progression of multiple myeloma.
Danish: Dette kan medvirke til at reducere den hastighed, hvormed multipelt myelom udvikler sig.
English: Thalidomide Celgene is available as capsules (50 mg).
Danish: Thalidomide Celgene fås som kapsler (50 mg).
English: Thalidomide is a powerful human ‘teratogen', meaning that it has harmful effect on the unborn child, causing severe and life-threatening birth defects.
Danish: Thalidomid er et kraftigt humant "teratogen", dvs. det har en skadelig virkning på det ufødte barn og forårsager alvorlige og livstruende fødselsdefekter.
English: Patients receiving melphalan and prednisone lived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Danish: De patienter, der fik melphalan og prednison, levede i gennemsnit 33,2 måneder fra studiets start sammenlignet med 51,6 måneder, når behandlingen også omfattede Thalidomide Celgene.
English: Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting 6 weeks.
Danish: Thalidomide Celgene kan anvendes i maksimalt 12 behandlingsserier, hvor hver serie varer i seks uger.
English: The most common side effects with Thalidomide Celgene used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), sleepiness, constipation and peripheral oedema (swelling, usually in the legs).
Danish: De hyppigste bivirkninger ved Thalidomide Celgene anvendt sammen med melphalan og prednison (som optræder hos mere end 1 ud af 10 patienter) er neutropeni (lavt antal neutrofiler, en type hvide blodlegemer), leukopeni (lavt antal hvide blodlegemer), anæmi (lavt antal røde blodlegemer), lymfopeni (lavt antal lymfocytter, en anden type hvide blodlegemer), trombocytopeni (lavt antal blodplader), perifer neuropati (nerveskade, der forårsager snurren, smerte og følelsesløshed i hænder og fødder), rysten, svimmelhed, paræstesi (stikkende og prikkende fornemmelse), nedsat følesans, søvnighed, forstoppelse og perifært ødem (hævelse, som regel i benene).
English: The doctor must also understand the risks of thalidomide and how its use must be monitored.
Danish: Lægen skal også kende risiciene ved thalidomid og vide, hvordan anvendelsen af lægemidlet skal overvåges.