FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious side effects occur in most patients.
Danish: Alvorlige bivirkninger opstår hos de fleste patienter.
English: As for all medicines, data on the use of Kymriah are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Kymriah løbende overvåget.
English: Kymriah is a medicine for treating two types of blood cancer:
Danish: Kymriah er et lægemiddel til behandling af to typer blodkræft:
English: The majority of patients who responded to Kymriah continued to have a response after 19 months.
Danish: Størstedelen af de patienter, der reagerede på Kymriah, havde fortsat respons efter 19 måneder.
English: Around 24% of patients had a complete response and 34% had at least a partial response after at least 3 months.
Danish: Ca. 24 % af patienterne havde fuldstændig respons, og 34 % havde mindst partiel respons efter mindst 3 måneder.
English: CAR can attach to another protein on the surface of cancer cells called CD19.
Danish: CAR kan binde til et andet protein på overfladen af de kræftceller, der hedder CD19.
English: This was better than results seen with the cancer medicines clofarabine, blinatumomab or a combination of clofarabine, cyclophosphamide and etoposide.
Danish: Dette var bedre end de resultater, der sås med kræftlægemidlerne clofarabin, blinatumomab eller en kombination af clofarabin, cyclofosfamid og etoposid.
English: The European Medicines Agency therefore decided that Kymriah'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 Kymriah opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Why is Kymriah authorised in the EU?
Danish: Hvorfor blev Kymriah godkendt i EU?
English: What is Kymriah and what is it used for?
Danish: Hvad er Kymriah, og hvad anvendes det til?
English: Side effects reported with Kymriah are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Kymriah vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The company must carry out several studies to obtain more information on Kymriah including its safety and effectiveness in the long term and in B-cell ALL patients under 3 years of age.
Danish: Virksomheden skal gennemføre adskillige studier for at opnå mere information om Kymriah, herunder sikkerheden og virkningen på lang sigt og hos patienter under 3 år med B-celle ALL.
English: For more information about using Kymriah, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Kymriah, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: An overview of Kymriah and why it is authorised in the EU
Danish: En oversigt over Kymriah, og hvorfor det er godkendt i EU
English: This is a type of medicine that works by delivering genes into the body.
Danish: Denne type lægemiddel virker ved at tilføre kroppen nogle gener.
English: Around 66% of patients had a complete response (which means they had no signs of the cancer left) in the 3 months after treatment.
Danish: Ca. 66 % af patienterne havde fuldstændig respons (dvs. de havde ingen tegn på kræft tilbage) 3 måneder efter behandlingen.
English: The blood cancers that Kymriah is used to treat are rare, and Kymriah was designated an ‘orphan medicine' (a medicine used in rare diseases) for B-cell ALL on 29 April 2014 and DLBCL on 14 October
Danish: De blodkræfttyper, som Kymriah anvendes mod, er sjældne, og Kymriah blev udpeget som "lægemiddel til sjældne sygdomme" mod B-celle ALL den 29. april 2014 og DLBCL den 14. oktober
English: What are the risks associated with Kymriah?
Danish: Hvilke risici er der forbundet med Kymriah?
English: Twelve months after treatment, the likelihood of survival was 40%.
Danish: Tolv måneder efter behandlingen var sandsynligheden for overlevelse 40 %.
English: Twelve months after treatment, the likelihood of survival was 70%.
Danish: Tolv måneder efter behandlingen var sandsynligheden for overlevelse 70 %.
English: In patients with DLBCL treated with Kymriah, the results were similar to other treatments but ongoing study data indicate that the effects last longer.
Danish: Hos patienter med DLBCL, der fik Kymriah, svarede resultaterne til andre behandlinger, men data fra igangværende studier indikerer, at virkningen varer længere.
English: Kymriah contains the active substance tisagenlecleucel (consisting of genetically modified white blood cells).
Danish: Kymriah indeholder det aktive stof tisagenlecleucel (der består af genmodificerede hvide blodlegemer).
English: The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure) and decreases in platelets (components that help the blood to clot), haemoglobin (the protein found in red blood cells that carries oxygen around the body) or white blood cells including neutrophils and lymphocytes.
Danish: De hyppigste alvorlige bivirkninger er cytokinfrigivelsessyndrom (en potentielt livstruende tilstand, der kan medføre feber, opkastning, åndenød, smerter og lavt blodtryk) og fald i niveauet af blodplader (bestanddele, der hjælper blodet med at størkne), hæmoglobin (et protein i de røde blodlegemer, som transporterer ilt rundt i kroppen) eller hvide blodlegemer, herunder neutrofiler og lymfocytter.
English: B-cell ALL patients have poor outcomes and improvements with Kymriah were better than with other medicines for this condition.
Danish: Patienter med B-celle ALL har dårlige prognoser, og forbedringen ved behandling med Kymriah var større end med andre lægemidler mod denne sygdom.
English: The main study of Kymriah in DLBCL involved 165 patients who had at least 2 previous treatments and could not have a stem cell transplant.
Danish: Hovedstudiet af Kymriah hos patienter med DLBCL omfattede 165 patienter, som havde mindst 2 tidligere behandlinger, og som ikke kunne få en stamcelletransplantation.
English: Kymriah is a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Kymriah er et lægemiddel til avanceret terapi, som kaldes et "genterapiprodukt".
English: When Kymriah is given to the patient, the modified T cells attach to and kill the cancer cells, thereby helping to clear the cancer from the body.
Danish: Når Kymriah gives til patienten, binder de modificerede T-celler sig til kræftcellerne og dræber dem, hvormed de hjælper med at fjerne kræften fra kroppen.
English: A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
Danish: Et lægemiddel, der hedder tocilizumab, og udstyr til nødbehandling skal være tilgængelige i tilfælde af, at patienten får en potentielt alvorlig bivirkning, der hedder cytokinfrigivelsessyndrom (se afsnittet vedrørende risici nedenfor).
English: Tocilizumab must be available in case of cytokine release syndrome.
Danish: Tocilizumab skal være tilgængeligt i tilfælde af cytokinfrigivelsessyndrom.
English: Kymriah contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Danish: Kymriah indeholder patientens egne T-celler (en type hvide blodlegemer), der er blevet genetisk modificeret i et laboratorium, så de fremstiller et protein, der hedder kimær antigenreceptor (CAR).
English: The company that markets Kymriah must ensure that hospitals where Kymriah is given have appropriate expertise, facilities and training.
Danish: Virksomheden, der markedsfører Kymriah, skal sikre, at de hospitaler, hvor Kymriah gives, har den nødvendige ekspertise og relevant udstyr, og at deres personale er trænet i behandling med dette lægemiddel.
English: For the full list of side effects and restrictions with Kymriah, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Kymriah fremgår af indlægssedlen.
English: The company must provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.
Danish: Virksomheden skal udarbejde informationsmateriale til sundhedspersoner og patienter om bivirkningerne, især cytokinfrigivelsessyndrom.
English: • Diffuse large B-cell lymphoma (DLBCL) in adults whose cancer has come back or did not respond after two or more previous treatments.
Danish: • diffust storcellet B-celle lymfom (DLBCL) hos voksne, hvis kræftsygdom er vendt tilbage eller ikke har reageret på to eller flere tidligere behandlinger.
English: • B-cell acute lymphoblastic leukaemia (ALL), in children and young adults up to 25 years of age whose cancer did not respond to previous treatment, has come back two or more times, or has come back after a transplant of stem cells;
Danish: • B-celle akut lymfoblastær leukæmi (ALL) hos børn og unge voksne op til 25 år, hvis kræftsygdom ikke har reageret på tidligere behandling, er vendt tilbage to eller flere gange eller er vendt tilbage efter transplantation af stamceller
English: The main study of Kymriah in B-cell ALL involved 92 children and young adults (3-25 years of age) whose cancer had come back after previous treatment or did not respond to treatment.
Danish: Hovedstudiet af Kymriah hos patienter med B-celle ALL omfattede 92 børn og unge voksne (i alderen 3-25 år), hvis kræft var vendt tilbage efter tidligere behandling eller ikke reagerede på behandling.
English: How is Kymriah used?
Danish: Hvordan anvendes Kymriah?
English: What benefits of Kymriah have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kymriah?
English: Kymriah is prepared using the patient's own white blood cells which are extracted from the blood and genetically modified in the laboratory.
Danish: Kymriah fremstilles ved hjælp af patientens egne hvide blodlegemer, der udvindes af blodet, og som derefter modificeres genetisk i et laboratorium.
English: How does Kymriah work?
Danish: Hvordan virker Kymriah?
English: Serious side effects, occur in most patients, and can include cytokine release syndrome.
Danish: De fleste patienter oplever alvorlige bivirkninger, som kan omfatte cytokinfrigivelsessyndrom.
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Kymriah, the patient should have a short course of chemotherapy to clear away their white blood cells and just before the infusion, they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Danish: Før indgivelsen af Kymriah bør patienten behandles kortvarigt med kemoterapi for at få reduceret antallet af hvide blodlegemer, og umiddelbart før infusionen bør de få paracetamol og et antihistaminlægemiddel for at minimere risikoen for reaktioner på infusionen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kymriah 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 Kymriah.
English: (Invented)name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Tell your relatives, friends and close colleagues the following:
Danish: Fortæl familie, venner og kollegaer følgende:
English: Date of first authorisation: 9 June 2000 Date of latest renewal: 17 February 2015
Danish: Dato for første markedsføringstilladelse: 9. juni 2000 Dato for seneste fornyelse: 17. februar 2015
English: • Contamination and/or infection,
Danish: • Kontaminering og/eller infektion.
English: No new safety signals were observed in this study.
Danish: Der blev ikke observeret nye sikkerhedssignaler i dette forsøg.
English: • Children below 2 years of age
Danish: • Børn under 2 år
English: Perform a Safety test
Danish: Udfør en sikkerhedstest
English: Use only clear and colourless solutions.
Danish: Anvend kun klare og farveløse opløsninger.
English: Please, consult your doctor for further information.
Danish: Kontakt venligst din læge for yderligere information.
English: Avoid situations where SoloStar might be damaged.
Danish: Undgå situationer hvor SoloStar kan blive ødelagt.
English: Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.
Danish: Afbryd ikke behandlingen med Lantus uden at tale med din læge, som vil fortælle dig, hvad der skal gøres.
English: MedDRA system organ classes
Danish: MedDRA Systemorganklasse
English: Other source of information
Danish: Andre informationskilder
English: Each pen contains multiple doses.
Danish: Hver pen indeholder mange doser.
English: This should be kept in mind if treatment with the combination of pioglitazone and Lantus is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Lantus overvejes.
English: The exposure to M1 increases with the administered dose of Lantus.
Danish: Eksponeringen for M1 øges med den administrerede dosis af Lantus.
English: You need one injection of Lantus every day, at the same time of the day.
Danish: Du skal have én injektion af Lantus hver dag på samme tid af dagen.
English: Inspect Lantus before use.
Danish: Undersøg Lantus før brug.
English: Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Danish: Tag omgående ca. 10-20 g sukker f.eks. som glucose, hugget sukker eller en sukkersødet drik.
English: To prevent the possible transmission of disease, never share your pen with anyone else.
Danish: For at undgå overførsel af sygdomme, må du aldrig dele din pen med andre.
English: Low blood sugar means that there is not enough sugar in your blood.
Danish: Lavt blodsukker betyder, at der ikke er nok sukker i blodet.
English: In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.
Danish: I dette tilfælde kan du enten injicere hvad der er tilbage i pennen og få resten af dosis fra en ny SoloStar eller anvende en ny SoloStar til hele din dosis.
English: Your doctor will show you in which area of the skin you should inject Lantus.
Danish: Din læge vil vise dig i hvilke hudområder, du skal injicere Lantus.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Danish: Det bør i sådanne tilfælde overvejes, om bilkørsel eller betjening af maskiner er tilrådelig.
English: Special population
Danish: Særlig population
English: If you turn past your dose, you can turn back down.
Danish: Hvis du drejer forbi din dosis kan du dreje tilbage igen.
English: If the hypoglycaemia comes back again take another 10 to 20 g sugar.
Danish: Hvis du igen får hypoglykæmi, skal du indtage endnu 10-20 g sukker.
English: The insulin may not work very well.
Danish: Insulinen virker måske ikke så godt.
English: Summary of the safety profile
Danish: Resume af sikkerhedsprofilen
English: This pen is only for your use.
Danish: Denne pen er kun til personlig brug.
English: Needles are not included in the pack.
Danish: Nåle findes ikke i pakningen.
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Danish: Fertilitet Dyrestudier viser ingen skadelig effekt med hensyn til fertilitet.
English: You can set doses from 1 to 80 units in steps of 1 unit.
Danish: Du kan sætte dosis fra 1 til 80 enheder i trin af 1 enhed.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Danish: Insulinbehovet kan falde i første trimester og stiger normalt igen i andet og tredje trimester.
English: If you are concerned that your SoloStar may be damaged, use a new one.
Danish: Hvis du er bekymret for om SoloStar kan være ødelagt, så brug en ny.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Danish: Normalt bør du være i stand til at mærke, når blodsukkeret falder for meget, så du kan tage de rette forholdsregler.
English: - Do not take a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: In general, the safety profile for children and adolescents (≤18 years of age) is similar to the safety profile for adults.
Danish: Generelt er sikkerhedsprofilen for børn og unge (≤ 18 år) er magen til sikkerhedsprofilen for voksne.
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Switch from other insulins to Lantus
Danish: Skift fra andre insuliner til Lantus
English: Not all of these pens may be marketed in your country.
Danish: Ikke alle disse penne er nødvendigvis markedsført i dit land.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Danish: Følgende relaterede bivirkninger, forekommet i kliniske studier, er nedenfor opstillet efter organsystem og faldende hyppighed (meget almindelig: >1/10; almindelig: >1/100 til <1/10; ikke almindelig: >1/1.000 til <1/100; sjælden: >1/10.000 til <1/1.000; meget sjælden: <1/10.000).
English: Activity profile in patients with type 1 diabetes
Danish: Virkningsprofil for type 1-diabetikere
English: This ensures that the full dose will be delivered.
Danish: Dette sikrer at hele dosis er udløst.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms (see section 4.4).
Danish: Generelt gælder det, at jo større og hurtigere faldet i blodglucosen er, des mere udtalt er modregulationstilstanden og dens symptomer (se pkt.
English: Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Danish: Sekundære effektmål omfattede mortalitet af alle årsager og et sammensat mikrovaskulært effektmål.
English: • removing air bubbles
Danish: • Fjerne luftbobler.
English: • Always perform the safety test before each injection (see Step 3).
Danish: • Udfør altid en sikkerhedstest før hver injektion (se Trin 3).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Danish: Du bør være bekendt med disse faktorer for at kunne handle korrekt i tilfælde af ændringer i dit blodsukker og for at forhindre, at blodsukkeret bliver for højt eller for lavt.
English: Via Valcanello, 4 03012 Anagni (FR) Italy
Danish: Via Valcanello, 4 03012 Anagni (FR) Italien
English: *Insulin glargine is produced by recombinant DNA technology in Escherichia coli.
Danish: *Insulin glargin er fremstillet ved rekombinant DNA-teknologi i Escherichia coli.
English: The use of Lantus may be considered during pregnancy, if clinically needed.
Danish: Anvendelsen af Lantus til gravide kan overvejes, hvis det behandlingsmæssigt er nødvendigt.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Danish: De fleste mindre alvorlige reaktioner på insulin forsvinder som regel i løbet af et par dage til få uger.
English: • Always have a spare SoloStar in case your SoloStar is lost or damaged.
Danish: • Opbevar altid en ekstra SoloStar i tilfælde af at din SoloStar bliver væk eller går i stykker.
English: Since Lantus is a solution, it does not require resuspension before use.
Danish: Da Lantus er en opløsning, er resuspension ikke nødvendig før brug.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Danish: Ændringer i styrke, brand (fremstiller), type (regular, NPH, lente, langtidsvirkende, etc.), oprindelse (animalsk, human, human insulinanalog) og/eller fremstillingmetode kan medføre, at det kan være nødvendigt at ændre dosis.
English: Over the course of this 6-year study, 42% of the insulin glargine group did not experience any hypoglycaemia.
Danish: I løbet af dette 6-års studie oplevede 42 % af patienterne i insulin glargin-gruppen ingen hypoglykæmi.
English: This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Danish: Dette kan medføre alvorlig hyperglykæmi (meget forhøjet blodsukker) og ketoacidose (syreophobning i blodet fordi kroppen nedbryder fedt i stedet for sukker).
English: Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia.
Danish: Lantus må IKKE injiceres i en blodåre, da dette vil ændre dets virkning, og kan forårsage hypoglykæmi.
English: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Danish: En stor mængde data fra gravide kvinder (mere end 1.000 graviditeter) viser ingen specifikke skadelige virkninger af insulin glargin på graviditet og ingen specifikke misdannelser eller føtal/neonatal toksicitet.
English: Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people).
Danish: Hypoglykæmi (lavt blodsukker) kan være meget alvorligt og er meget almindeligt ved insulinbehandling (forekommer hos flere end 1 ud af 10 patienter).
English: B. Insert the needle into the skin.
Danish: B. Nålen stikkes ind i huden.
English: Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.
Danish: Anvend ikke SoloStar, hvis den er beskadiget eller ikke virker ordentligt, den skal kasseres og en ny SoloStar tages i brug.
English: These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.
Danish: Disse cylinderampuller bør ikke bruges med andre former for flergangspenne, da dosis-nøjagtighed kun er vist med ovenstående penne.
English: If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
Danish: Hvis du har svært ved at genkende dine advarselssymptomer, bør du undgå situationer (såsom bilkørsel), hvor du selv eller andre kan bringes i fare på grund af risikoen for hypoglykæmi.
English: It is completely soluble at the acidic pH of the Lantus injection solution (pH 4).
Danish: Det er fuldstændig opløseligt ved den sure pH i opløsningen af Lantus (pH 4).
English: If you have any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local representative number on the front of this leaflet.
Danish: Hvis du har nogen spørgsmål vedrørende SoloStar eller vedrørende diabetes, så spørg dit sundhedspersonale eller ring til nummeret på den lokale repræsentant på forsiden af denne indlægsseddel.