FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second study, involving 531 patients with type 2 diabetes, the average reduction in HbA1c was from 8.3 to 7.2% with Lusduna and from 8.4 to 7.2% with Lantus.
Danish: I den anden supplerende undersøgelse, der omfattede 531 patienter med type 2-diabetes, blev den gennemsnitlige HbA1c-værdi reduceret fra 8,3 til 7,2 % for Lusduna og fra 8,4 til 7,2 % for Lantus.
English: For more information about treatment with Lusduna, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lusduna, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Lusduna is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood.
Danish: Lusduna er et erstatningsinsulin, der fungerer på samme måde som kroppens eget insulin og hjælper glukosen (sukkeret) med at komme ind i cellerne fra blodet.
English: It is not intended to provide practical advice on how to use Lusduna.
Danish: Det er ikke en praktisk vejledning i, hvordan Lusduna bør anvendes.
English: What are the risks associated with Lusduna?
Danish: Hvilke risici er der forbundet med Lusduna?
English: Extensive laboratory studies comparing Lusduna with Lantus have shown that insulin glargine in Lusduna is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Danish: Omfattende laboratorieundersøgelser, der sammenlignede Lusduna med Lantus, har vist, at det aktive stof (insulin glargin) i Lusduna minder meget om det aktive stof i Lantus, hvad angår kemisk struktur, renhed og biologisk aktivitet.
English: Two additional studies showed that Lusduna is absorbed into the body and works on blood glucose in the same way as the reference medicine, Lantus.
Danish: To yderligere undersøgelser har vist, at Lusduna optages i kroppen og indvirker på blodsukkeret på samme måde som referencelægemidlet, Lantus.
English: Lusduna is a medicine used in patients aged at least 2 years for the treatment of diabetes.
Danish: Lusduna er et lægemiddel, der anvendes til behandling af diabetes hos patienter i alderen 2 år og derover.
English: Why is Lusduna approved?
Danish: Hvorfor blev Lusduna godkendt?
English: For practical information about using Lusduna, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lusduna, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In both studies, the main measure of effectiveness was the change after 24 weeks of treatment in the level in the blood of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled.
Danish: I disse to undersøgelser blev virkningen hovedsagelig bedømt på ændringen i blodets indhold af glykosyleret hæmoglobin (HbA1c) efter 24 ugers behandling.
English: Lusduna insulin glargine
Danish: Lusduna insulin glargin
English: Because Lusduna is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Danish: Lusduna er et biosimilært lægemiddel, og derfor har det ikke været nødvendigt at gennemføre undersøgelser af Lusdunas virkning og sikkerhed, da det aktive stof, insulin glargins virkning og sikkerhed er veldokumenteret.
English: Lusduna is available in pre-filled disposable pens and can only be obtained with a prescription.
Danish: Lusduna fås i fyldte engangspenne og udleveres kun efter recept.
English: What benefits of Lusduna have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lusduna?
English: Two supportive studies found that the effectiveness of once-daily Lusduna was comparable to Lantus.
Danish: To understøttende undersøgelser har vist, at Lusduna taget én gang dagligt har samme virkning som Lantus.
English: For the full list of all side effects and restrictions with Lusduna, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved og begrænsninger for Lusduna fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lusduna have 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 Lusduna.
English: The dose of Lusduna is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines.
Danish: Lusduna-dosen fastsættes individuelt for den enkelte patient ud fra dennes niveau af glukose (sukker) i blodet og alt efter, hvilke andre insulinpræparater vedkommende eventuelt behandles med. Lusduna kan også anvendes sammen med diabetesmedicin i tabletform hos patienter med type 2-diabetes.
English: Further information on Talzenna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/talzenna
Danish: Yderligere information om Talzenna findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/talzenna
English: Other information about Talzenna
Danish: Andre oplysninger om Talzenna
English: Talzenna is available as capsules (1 mg and 0.25 mg) and the recommended dose is 1 mg once a day.
Danish: Talzenna fås som kapsler (1 mg og 0,25 mg), og den anbefalede dosis er 1 mg en gang dagligt.
English: As for all medicines, data on the use of Talzenna are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Talzenna løbende overvåget.
English: The dose may be reduced or treatment interrupted if certain side effects develop.
Danish: Dosis kan reduceres eller behandlingen kan afbrydes, hvis der opstår visse bivirkninger.
English: Women must not breastfeed during treatment with Talzenna and for a month after stopping treatment.
Danish: Kvinder må ikke amme under behandlingen med Talzenna og i en måned efter behandlingens afslutning.
English: What measures are being taken to ensure the safe and effective use of Talzenna?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Talzenna?
English: What is Talzenna and what is it used for?
Danish: Hvad er Talzenna, og hvad anvendes det til?
English: An overview of Talzenna and why it is authorised in the EU
Danish: En oversigt over Talzenna, og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that Talzenna's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Talzenna opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Talzenna authorised in the EU?
Danish: Hvorfor er Talzenna godkendt i EU?
English: Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and as a result the cancer cells die.
Danish: Når PARP-proteinerne blokeres, kan de ikke reparere det beskadigede dna i kræftcellerne, og kræftcellerne dør følgelig.
English: Talzenna contains the active substance talazoparib.
Danish: Talzenna indeholder det aktive stof talazoparib.
English: Treatment should continue for as long as the patient continues to benefit from it and side effects are tolerable.
Danish: Behandlingen bør fortsætte så længe, patienten har gavn af den og kan tolerere bivirkningerne.
English: Talzenna can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Talzenna fås kun på recept, og behandlingen bør indledes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: For more information about using Talzenna, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Talzenna, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Side effects reported with Talzenna are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Talzenna vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Talzenna?
Danish: Hvilke risici er der forbundet med Talzenna?
English: The active substance in Talzenna, talazoparib, blocks the action of enzymes called human poly-ADP ribose polymerase (PARP), which are proteins that help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Danish: Det aktive stof i Talzenna, talazoparib, blokerer virkningen af enzymer kaldet humane poly-ADPribosepolymeraser (PARP), som er proteiner, der hjælper med at reparere beskadiget dna i cellerne (både normale celler og kræftceller) under celledelingen.
English: Talzenna can increase the time these patients live without their disease getting worse.
Danish: Talzenna kan forlænge den tid, som patienterne lever uden sygdomsforværring.
English: Patients treated with Talzenna lived on average for 8.6 months without their disease getting worse compared with 5.6 months for patients treated with the doctor's choice of another cancer medicine.
Danish: De patienter, der blev behandlet med Talzenna, levede gennemsnitligt i 8,6 måneder uden sygdomsforværring, sammenholdt med 5,6 måneder for de patienter, der fik et andet kræftlægemiddel efter lægens valg.
English: The side effects with Talzenna were generally well-tolerated and when needed, manageable with dose modifications, and/or standard supportive medical therapy.
Danish: Bivirkningerne ved Talzenna var generelt veltolererede og kunne efter behov håndteres med dosisændringer og/eller medicinsk standardstøtteterapi.
English: The most common severe side effects (which may affect more than 1 in 10 people) which led to changes in the dose of Talzenna are anaemia, neutropenia and thrombocytopenia.
Danish: De hyppigste alvorlige bivirkninger (som kan forekomme hos mere end 1 ud af 10 personer), der førte til ændring af dosen af Talzenna, er anæmi, neutropeni og trombocytopeni.
English: Generally the outcome is poor for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Danish: Generelt er resultatet ringe for patienter med HER2-negativ brystkræft med BRCA-mutationer, hvis kræft har spredt sig.
English: For the full list of side effects and restrictions with Talzenna, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Talzenna fremgår af indlægssedlen.
English: The most common side effects with Talzenna (which may affect more than 1 in 4 people) are tiredness, anaemia (low red blood cell counts which can cause tiredness and pale skin), nausea (feeling sick), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), thrombocytopenia (low blood levels of platelets), and headache.
Danish: De hyppigste bivirkninger ved Talzenna (som kan forekomme hos mere end 1 ud af 4 personer) er træthed, anæmi (lavt antal røde blodlegemer, der kan forårsage træthed og bleg hud), kvalme, neutropeni (lavt antal neutrofiler, en type hvide blodlegemer, der bekæmper infektion) , trombocytopeni (for lavt antal blodplader) og hovedpine.
English: Talzenna is a cancer medicine used on its own to treat a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site, in patients who have been treated with certain medicines which have stopped working or when these medicines are not suitable.
Danish: Talzenna er et kræftlægemiddel, der anvendes til enebehandling af en type brystkræft (HER2-negativ med BRCA-mutationer), der har spredt sig uden for det oprindelige område, hos patienter, der er blevet behandlet med visse lægemidler, som ikke længere virker eller ikke er egnede.
English: What benefits of Talzenna have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Talzenna?
English: Talzenna was shown to be effective at increasing the time patients live without their disease getting worse in one main study involving 431 patients with HER2-negative breast cancer with BRCA mutations whose cancer had spread.
Danish: Det blev påvist, at Talzenna var effektiv til at øge den tid, patienterne levede uden sygdomsforværring, i et hovedstudie med 431 patienter med HER2-negativ brystkræft med BRCA-mutationer, hvis kræft havde spredt sig.
English: How does Talzenna work?
Danish: Hvordan virker Talzenna?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Talzenna have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Talzenna.
English: How is Talzenna used?
Danish: Hvordan anvendes Talzenna?
English: Fasenra received a marketing authorisation valid throughout the EU on 8 January 2018.
Danish: Fasenra fik en markedsføringstilladelse med gyldighed i hele EU den 8. januar 2018.
English: Further information on Fasenra can be found on the Agency's website: ema.europa.eu/medicines/Human/EPAR/fasenra.
Danish: Yderligere information om Fasenra findes på agenturets websted under: ema.europa.eu/medicines/Human/EPAR/fasenra.
English: Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.
Danish: Fasenra bør gives, så længe patienten har gavn af det, og lægen bør mindst én gang årligt vurdere, om behandlingen skal fortsætte.
English: The medicine is well tolerated with few side effects.
Danish: Lægemidlet er veltolereret og giver kun få bivirkninger.
English: As for all medicines, data on the use of Fasenra are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Fasenra løbende overvåget.
English: If the injection is given by a doctor or carer, it can also be given under the skin of the upper arm.
Danish: Hvis injektionen gives af en læge eller plejer, kan det også gives under huden på overarmen.
English: The European Medicines Agency therefore decided that Fasenra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Fasenra opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Fasenra?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fasenra?
English: The recommended dose is 30 mg injected under the skin of the thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards.
Danish: Den anbefalede dosis er 30 mg injiceret under huden på låret eller maven hver 4. uge ved de første 3 doser og derefter hver 8. uge.
English: Other information about Fasenra
Danish: Andre oplysninger om Fasenra
English: Side effects reported with Fasenra are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Fasenra vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Fasenra and why it is authorised in the EU
Danish: En oversigt over Fasenra, og hvorfor det er godkendt i EU
English: What is Fasenra and what is it used for?
Danish: Hvad er Fasenra, og hvad anvendes det til?
English: If agreed with the treating doctor, patients already using Fasenra and with no history of severe allergic reactions, or their carers, can inject Fasenra themselves after proper training, including on how to watch out for signs and symptoms of allergic reactions.
Danish: Hvis det aftales med den behandlende læge, kan patienter, der allerede anvender Fasenra, og som ikke har haft alvorlige allergiske reaktioner, eller deres plejere selv injicere Fasenra efter passende oplæring, herunder i, hvordan man holder øje med tegn og symptomer på allergiske reaktioner.
English: Why is Fasenra authorised in the EU?
Danish: Hvorfor er Fasenra godkendt i EU?
English: For more information about using Fasenra, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Fasenra, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Fasenra contains the active substance benralizumab.
Danish: Fasenra indeholder det aktive stof benralizumab.
English: A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.
Danish: I et tredje studie med 220 patienter blev det påvist, at flere af de patienter, der fik Fasenra, oplevede en så stor bedring af deres sygdom, at de kunne reducere dosen af kortikosteroider med gennemsnitligt 75 %, sammenholdt med 25 % blandt dem, der fik placebo.
English: Among patients with the highest number of blood eosinophils before treatment, the number of severe flareups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).
Danish: Blandt patienterne med det højeste antal eosinofiler i blodet før behandling var antallet af svære forværringer pr. år 0,66 hos patienter behandlet med Fasenra (givet hver 4. uge ved de første 3 doser og derefter hver 8. uge) sammenholdt med 1,14 hos de patienter, der fik placebo (en uvirksom behandling).
English: This helps to reduce inflammation, resulting in a reduction in asthma attacks and improvement of symptoms.
Danish: Derved mindskes inflammationen, så der kommer færre astmaanfald og symptomerne bedres.
English: What are the risks associated with Fasenra?
Danish: Hvilke risici er der forbundet med Fasenra?
English: Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment.
Danish: Det er påvist, at Fasenra er mere effektivt end placebo til at reducere antallet af astmaforværringer og behovet for kortikosteroidbehandling.
English: The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils.
Danish: Det aktive stof i Fasenra, benralizumab, er et monoklonalt antistof (en type protein), der er designet til at binde til receptorer (mål), der hedder interleukin-5, på overfladen af eosinofiler.
English: It can only be obtained with a prescription and treatment should be started by doctors with experience in the diagnosis and treatment of severe asthma.
Danish: Det fås kun på recept og bør ordineres af en læge med erfaring i at diagnosticere og behandle svær astma.
English: The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat).
Danish: De hyppigste bivirkninger ved Fasenra (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine og ondt i halsen.
English: By attaching to interleukin-5 receptors,
Danish: Ved at binde til interleukin-5-receptorerne aktiverer Fasenra immunsystemet,
English: For the full list of side effects and restrictions of Fasenra, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Fasenra fremgår af indlægssedlen.
English: Fasenra is an asthma medicine used to treat adults with a particular type of asthma called eosinophilic asthma.
Danish: Fasenra er et lægemiddel til behandling af voksne med en særlig type astma, der kaldes eosinofil astma.
English: Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists.
Danish: Det er påvist, at Fasenra reducerer antallet af forværringer (eksacerbationer) af astma under behandlingen, i to hovedstudier med i alt 2 511 patienter med eosinofil astma, der ikke var tilstrækkeligt kontrolleret med en kombination af en høj dosis inhalationskortikosteroider og langtidsvirkende beta-agonister.
English: It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists.
Danish: Det anvendes som supplerende behandling hos voksne med svær astma, der ikke er tilstrækkeligt kontrolleret med en kombination af en høj dosis inhalationskortikosteroider (binyrebarkhormon) og såkaldte langtidsvirkende beta-agonister.
English: In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs.
Danish: Symptomerne ved eosinofil astma skyldes, at der er for mange såkaldte eosinofiler (en type hvide blodlegemer) i blodet og i slimen i lungerne.
English: Fasenra is available as a solution for injection in pre-filled syringes and pre-filled pens.
Danish: Fasenra fås som injektionsvæske i fyldte sprøjter og penne.
English: What benefits of Fasenra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Fasenra?
English: How is Fasenra used?
Danish: Hvordan anvendes Fasenra?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fasenra have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fasenra.
English: Fasenra activates the immune system (the body's natural defences) to kill the eosinophils in the blood and lungs.
Danish: der er kroppens naturlige forsvar, så det dræber eosinofilerne i blodet og lungerne.
English: How does Fasenra work?
Danish: Hvordan virker Fasenra?
English: When should I seek advice or help?
Danish: Hvornår skal jeg søge råd eller hjælp?
English: Why do you get these symptoms?
Danish: Hvorfor får du disse symptomer?
English: • Eat slowly and eat smaller portions.
Danish: • Spis langsomt og spis mindre portioner
English: What can I do to help relieve my symptoms?
Danish: Hvad kan jeg gøre for at lindre mine symptomer?
English: • You lose a lot of weight for no reason.
Danish: • Du taber dig meget uden grund
English: There is very limited experience to date with deliberate overdose.
Danish: Der er til dato meget begrænset erfaring med bevidst overdosering.
English: Crospovidone (Type A)
Danish: Crospovidon (Type A)
English: Povidone K-17
Danish: Povidon K-17
English: Interaction studies have only been performed in adults.
Danish: Der er kun udført interaktionsundersøgelser på voksne.
English: Do not exceed this dose.
Danish: Overskrid ikke denne dosis.
English: Always stir the mixture just before drinking it.
Danish: Rør altid i blandingen, lige inden du drikker den
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 25 June 2018
Danish: Dato for første markedsføringstilladelse: 26. august 2013 Dato for seneste fornyelse: 25. juni 2018
English: If you forget to take a dose, take it as soon as you remember it, on the same day.
Danish: Hvis du glemmer en dosis, skal du tage den så snart, du kommer i tanke om det den samme dag.
English: Children and adolescents This medicine should not be used by children and adolescents under 18 years of age.
Danish: Denne medicin må ikke anvendes af børn og unge under 18 år.
English: • The treatment length is up to 14 days.
Danish: • Behandlingslængden er op til 14 dage
English: The duration of treatment is up to 2 weeks.
Danish: Behandlingsvarigheden er op til 2 uger.