FrancophonIA/ELRC3.0 huggingface dataset:
English: It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another medicine used to treat cancer), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Danish: Det anvendes desuden til børn i sygdommens "kroniske fase", hvis de ikke har reageret på interferon alfa (et andet lægemiddel til behandling af kræft), samt i mere fremskredne faser af sygdommen ("accelereret fase" og "blastkrise").
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Danish: Yderligere information om Imatinib Actavis findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
English: These enzymes can be found in some receptors on cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Danish: Disse enzymer findes i visse receptorer i kræftcellerne, herunder de receptorer, der medvirker til at stimulere cellerne til at dele sig ukontrolleret.
English: For more information about using Imatinib Actavis, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Imatinib Actavis, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Actavis.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Glivec, og det er ikke nødvendigt at gentage disse med Imatinib Actavis.
English: Side effects reported with Imatinib Actavis are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Imatinib Actavis vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Actavis has been shown to have comparable quality and to be bioequivalent to Glivec.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Imatinib Actavis er af sammenlignelig kvalitet og er bioækvivalent med Glivec.
English: Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013.
Danish: Imatinib Actavis fik en markedsføringstilladelse med gyldighed i hele EU den 17. april 2013.
English: As for all medicines, data on the use of Imatinib Actavis are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Imatinib Actavis løbende overvåget.
English: An overview of Imatinib Actavis and why it is authorised in the EU
Danish: En oversigt over Imatinib Actavis, og hvorfor det er godkendt i EU
English: It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
Danish: Det anvendes desuden alene hos voksne til behandling af Ph+ ALL, som er vendt tilbage efter forudgående behandling, eller når sygdommen ikke reagerer på andre lægemidler.
English: Imatinib Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body.
Danish: Imatinib Actavis anvendes til behandling af voksne med DFSP, der ikke kan fjernes ved operation, og til voksne, som ikke kan opereres, når kræften vender tilbage efter behandling, eller når den har bredt sig til andre dele af kroppen.
English: As for every medicine, the company provided studies on the quality of Imatinib Actavis.
Danish: Som for alle lægemidler fremlagde virksomheden studier vedrørende kvaliteten af Imatinib Actavis.
English: Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Imatinib Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What measures are being taken to ensure the safe and effective use of Imatinib Actavis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imatinib Actavis?
English: This means that it blocks enzymes known as tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer enzymer af typen tyrosinkinaser.
English: The medicine is used in children who have been newly diagnosed with Ph+ CML and who cannot have a bone marrow transplant.
Danish: Lægemidlet anvendes til børn, som for nylig har fået stillet diagnosen Ph+ CML, og som ikke er egnede til en knoglemarvstransplantation.
English: Imatinib Actavis is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Danish: Imatinib Actavis gives gennem munden sammen med et måltid og et stort glas vand for at mindske risikoen for irritation af mave-tarmkanalen.
English: Other information about Imatinib Actavis
Danish: Andre oplysninger om Imatinib Actavis
English: Imatinib Actavis is used when the patients are ‘Philadelphia-chromosome positive' (Ph+).
Danish: Imatinib Actavis anvendes, når patienten er "Philadelphiakromosompositiv" (Ph+).
English: What is Imatinib Actavis and what is it used for?
Danish: Hvad er Imatinib Actavis, og hvad anvendes det til?
English: Therefore, the Agency's view was that, as for Glivec, the benefit of Imatinib Actavis outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Imatinib Actavis opvejer de identificerede risici som for Glivec, og at det kan godkendes til anvendelse i EU.
English: Imatinib Actavis is a ‘generic medicine'.
Danish: Imatinib Actavis er et "generisk lægemiddel".
English: This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Glivec.
Danish: Det betyder, at Imatinib Actavis er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Glivec.
English: Imatinib Actavis is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Danish: Imatinib Actavis anvendes til behandling af voksne med HES eller CEL, hos hvem der forekommer en særlig omgruppering af de to gener FIP1L1 og PDGFRα
English: Imatinib Actavis is a cancer medicine that contains the active substance imatinib.
Danish: Imatinib Actavis er et kræftlægemiddel, der indeholder det aktive stof imatinib.
English: The active substance in Imatinib Actavis, imatinib, is a protein-tyrosine-kinase inhibitor.
Danish: Det aktive indholdsstof i Imatinib Actavis, imatinib, er en protein-tyrosinkinasehæmmer.
English: Imatinib Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Danish: Imatinib Actavis anvendes sammen med andre lægemidler mod kræft til voksne og børn, som for nylig har fået diagnosticeret Ph+ ALL.
English: What are the benefits and risks of Imatinib Actavis?
Danish: Hvilken fordel og risiko er der forbundet med Imatinib Actavis?
English: By blocking these receptors, Imatinib Actavis helps to control and slow down cell division.
Danish: Ved at blokere disse receptorer er Imatinib Actavis med til at begrænse celledelingen.
English: Imatinib Actavis is also used in adults with Ph+ CML in blast crisis.
Danish: Imatinib Actavis anvendes også til voksne med Ph + CML i blastkrise.
English: Why is Imatinib Actavis authorised in the EU?
Danish: Hvorfor blev Imatinib Actavis godkendt i EU?
English: Imatinib Actavis is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Danish: Imatinib Actavis anvendes til behandling af voksne med MD/MPD, hos hvem genet for blodpladederiveret vækstfaktorreceptor (PDGFR) har omgrupperet sig
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Actavis have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Imatinib Actavis.
English: • chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Danish: • kronisk myeloid leukæmi (CML), som er en form for kræft i de hvide blodlegemer, hvor granulocytter (en form for hvide blodlegemer) begynder at vokse ukontrolleret.
English: How is Imatinib Actavis used?
Danish: Hvordan anvendes Imatinib Actavis?
English: How has Imatinib Actavis been studied?
Danish: Hvordan blev IImatinib Actavis undersøgt?
English: How does Imatinib Actavis work?
Danish: Hvordan virker Imatinib Actavis?
English: Other paediatric population:
Danish: Anden pædiatrisk population:
English: If you forget one dose of Hexyon
Danish: Hvis du har glemt en dosis Hexyon
English: • Temperature of ≥ 40°C within 48 hours not due to another identifiable cause;
Danish: • Temperatur ≥ 40 °C inden for 48 timer, som ikke skyldes anden identificérbar årsag;
English: • As with any vaccine, Hexyon may not protect 100% of children who receive the vaccine.
Danish: • Som med enhver anden vaccine beskytter Hexyon ikke nødvendigvis 100 % af børn, der modtager vaccinen.
English: However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexyon but the protection may not be as good as in children whose immune system is healthy.
Danish: Men børn med langvarige problemer med deres immunsystem, såsom HIV-infektion (AIDS), kan stadig gives Hexyon, men beskyttelsen er muligvis ikke så god som hos børn med sundt immunsystem.
English: Vaccination with Hexyon may need to be delayed until your child is better.
Danish: Vaccination med Hexyon skal måske vente, indtil dit barn får det bedre.
English: • Hexyon will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine.
Danish: • Hexyon hjælper kun med at forebygge disse sygdomme, hvis de stammer fra de bakterier eller virus, som denne vaccine er rettet imod.
English: Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses.
Danish: Der blev observeret lidt højere reaktogenicitet efter den første dosis i forhold til efterfølgende doser.
English: 4.8 Undesirable effects a- Summary of the safety profile
Danish: 4.8 Bivirkninger a. Oversigt over sikkerhedsprofilen
English: Your doctor will advise you whether your child should have Hexyon.
Danish: Lægen vil rådgive dig, om barnet bør få Hexyon.
English: The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Danish: Vaccinens virkning var 96,7 % for den fulde primærserie og 98,5 % for booster-dosis (uanset priming).
English: To make sure that Hexyon is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Danish: For at være sikker på, at Hexyon er egnet til dit barn, er det vigtigt at tale med lægen eller sundhedspersonalet, hvis bare ét af punkterne herunder gælder dit barn.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlæggelsesseddel blev senest ændret {MM/ÅÅÅÅ}.
English: The administration of Hexyon must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components.
Danish: Administration af Hexyon skal overvejes omhyggeligt hos individer, der har en anamnese med svære eller alvorlige reaktioner inden for 48 timer fra administrering af en vaccine med lignende indholdsstoffer.
English: • Hexyon should not be mixed with other medicinal products.
Danish: • Hexyon må ikke blandes med andre lægemidler.
English: † See section c c- Description of selected adverse reactions
Danish: † Se afsnit c c. Beskrivelse af udvalgte bivirkninger
English: Multipack of 50 (5x10) (including blue box)
Danish: Multipakning med 50 (5x10) (inklusive blå boks)
English: Possible side effects Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Danish: Denne vaccine kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: In clinical studies in individuals who received Hexyon, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
Danish: I kliniske undersøgelser hos individer, der fik Hexyon, omfattede de hyppigst indberettede reaktioner smerte på injektionsstedet, irritabilitet, gråd og erytem på injektionsstedet.
English: Hexyon is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm.
Danish: Hexyon gives som en injektion ind i en muskel (intramuskulært, IM) i den øverste del af barnets ben eller overarm.
English: Hexyon must not be mixed with any other vaccines or other parenterally administered medicinal products.
Danish: Hexyon må ikke blandes med andre vacciner eller andre parenteralt administrerede lægemidler.
English: The safety of Hexyon in children over 24 months of age has not been studied in clinical trials.
Danish: Sikkerheden af Hexyon hos børn over 24 måneder er ikke blevet undersøgt i kliniske forsøg.
English: • Poliovirus (Inactivated) Types 1/2/3
Danish: • Poliovirus (inaktiveret) type 1/2/3
English: d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexyon and not directly with Hexyon)
Danish: d. Potentielle bivirkninger (dvs. bivirkninger, der er indberettet for andre vacciner, der indeholder et eller flere indholdsstoffer eller bestanddele i Hexyon og ikke direkte for Hexyon).
English: Pack of 1, 10 or 50.
Danish: Pakke med 1, 10 eller 50.
English: Hexyon is a whitish, cloudy suspension.
Danish: Hexyon er en hvidlig, uklar suspension.
English: Pyrexia (body temperature ≥ 38.0°C)
Danish: Pyreksi (legemstemperatur ≥ 38,0 °C)
English: Hexyon will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Danish: Hexyon vil blive givet til dit barn af en læge eller sygeplejerske, der er trænet i brugen af vacciner, og som er udstyret til at håndtere en uventet, svær allergisk reaktion på injektionen (se punkt 4 ”Bivirkninger”).
English: When given at the same time with other vaccines, Hexyon will be given at different injection sites.
Danish: Hvis det gives samtidigt med andre vacciner, vil Hexyon blive givet på forskellige injektionssteder.
English: Hexyon can be considered for the booster.
Danish: Hexyon kan anvendes som booster.
English: Other medicines or vaccines and Hexyon
Danish: Brug af anden medicin eller vaccine sammen med Hexyon
English: • Hexyon must be administered intramuscularly.
Danish: • Hexyon skal administreres intramuskulært.
English: History of an anaphylactic reaction after a previous administration of Hexyon.
Danish: Anamnese med anafylaktisk reaktion efter tidligere administration af Hexyon.
English: titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
Danish: PRP-niveau ≥ 0,15 µg/ml blev observeret hos 73,0 % af individerne, anti-PT-vaccinerespons hos 97,9% af individerne og anti-FHA vaccinerespons hos 98,6 % af individerne.
English: There may be a clinically relevant interference in the antibody response of Hexyon and a varicella vaccine and these vaccines should not be administered at the same time.
Danish: Der kan forekomme en klinisk påvirkning af antistofrespons på Hexyon og varicellavaccination, og disse vacciner må ikke administreres samtidigt.
English: Pack of 10 for multipack (without blue box)
Danish: Pakke med 10 multipakninger (uden blåboks)
English: Keep the container in the outer carton in order to protect from light.
Danish: Beholderen opbevares i den ydre pakning for at beskytte den mod lys.
English: The safety and efficacy of Hexyon in infants less than 6 weeks of age have not been established.
Danish: Hexyons sikkerhed og virkning hos spædbørn under 6 uger er ikke klarlagt.
English: These reactions start within 24-72 hours after vaccination, may be associated with redness, warmth, tenderness or pain at the injection site, and get better within 3-5 days without the need for treatment.
Danish: 24-72 timer efter vaccination, kan sammenknyttes med rødme, varme, ømhed eller smerte på injektionsstedet og bliver bedre inden for 3-5 dage uden behov for behandling.
English: Diphtheria Toxoid not less than 20 IU2
Danish: Difteri toxoid ikke mindre end 20 IE
English: Keep the vaccine in the outer carton in order to protect from light.
Danish: Vaccinen opbevares i den ydre pakning for at beskytte den mod lys.
English: • has had respiratory disorder or swelling of the face (anaphylactic reaction) after administration of Hexyon
Danish: • Har haft luftvejsbesvær eller hævelse i ansiget (anafylaktisk reaktion) efter administration af Hexyon
English: Months N=249** N=204† N=178†† N=177 to
Danish: N=204† N=178†† N=177 to 396‡
English: At the end of this period, Hexyon should be used or discarded.
Danish: Hexyon skal administreres inden for denne periode eller kasseres.
English: The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
Danish: Immunresponserne på PRP-, PT- og FHA-antigener en måned efter 2 doser, givet ved 2 og 4 måneder, svarede til dem, der blev observeret en måned efter en 2-dosis priming, givet ved 3 og 5 måneder: anti
English: Table 1: Seroprotection/Seroconversion rates* one month after a primary vaccination with 2 or 3 doses of Hexyon
Danish: Tabel 1: Serobeskyttelse/serokonversionsrate* én måned efter en primærvaccination med 2 eller 3 doser Hexyon
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexyon.
Danish: En anamnese med feberkramper, en familieanamnese med kramper eller vuggedød (SIDS) er ikke en kontraindikation for anvendelse af Hexyon.
English: The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexyon) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study.
Danish: Vaccinens effekt mod Hib invasiv sygdom fra DTaP og Hib kombinationsvacciner (pentavalente og hexavalente, herunder vacciner, der indeholder Hib-antigenet fra Hexyon er påvist i Tyskland via et omfattende studie (over fem års opfølgning) efter markedsføringen.
English: Hexyon may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.
Danish: Hexyon kan anvendes som en booster hos individer, som tidligere er blevet vaccineret med en anden hexavalent vaccine eller en pentavalent DTaP-IPV/HiB-vaccine i forbindelse med en monovalent hepatitis B-vaccine.
English: Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Danish: Hexyon beskytter ikke mod infektionssygdomme, der stammer fra andre typer Haemophilus influenzae eller mod meningitis af anden oprindelse.
English: In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.
Danish: I sådanne tilfælde skal pertussis vaccination afbrydes, og vaccinationsforløbet bør fortsættes med difteri, tetanus, hepatitis B, poliomyelitis og Hib-vacciner.
English: Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o.
Danish: Česká republika Sanofi Pasteur divize vakcín sanofi-aventis, s.r.o.
English: Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexyon against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal).
Danish: Vaccinens effektivitet af acellulær pertussis- (aP) antigener i Hexyon, i forhold til den sværeste WHOdefinerede, typiske pertussis (≥ 21 dages paroxysmal hoste) er dokumenteret i et randomiseret dobbeltblindt studie blandt spædbørn med primærserie på 3 doser ved brug af en DTaP-vaccine i et højt-endemisk land (Senegal).
English: Booster vaccination at 11-12 months of age after a two doses primary course
Danish: Boostervaccination ved 11-12måneders alderen efter primærvacci nation på to doser
English: After a 3-dose WHO EPI schedule with Hexyon (6, 10, 14 weeks) and in the absence of hepatitis B vaccination at birth, a hepatitis B vaccine booster must be given.
Danish: Efter en 3-dosis WHO EPI-serie med Hexyon (6, 10, 14 uger) og ved manglende hepatitis Bvaccination ved fødslen, skal der administreres en hepatitis B-vaccine booster-dosis.
English: Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexyon Antibody Thresholds
Danish: Tabel 3: Serobeskyttelse a i alderen 4,5 år efter vaccination with Hexyon
English: The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexyon (N=148) at 2, 4, 6 months of age.
Danish: Immunresponser på Hib- (PRP) og pertussis-antigener (PT og FHA) blev evalueret efter 2 doser i en undergruppe af patienter, som fik Hexyon (N = 148) ved 2-, 4-, 6-månedersalderen.
English: The long term capability of the acellular pertussis (aP) antigens contained in Hexyon to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule.
Danish: Langtideffekten af acellulær pertussis (aP) antigener i Hexyon til at reducere pertussis-forekomst og kontrollere pertussis-tilfælde i barndommen er påvist i en 10 års overvågning af pertussis-tilfælde i Sverige med pentavalent DTaP-IPV/Hib-vaccineserie ved 3, 5, 12 måneder.
English: Hexyon will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Danish: Hexyon forebygger ikke sygdom, der stammer fra andre patogener end Corynebacterium diphteriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus eller Haemophilus influenzae type b. Det kan dog forventes, at hepatitis D vil blive forebygget ved immunisering, idet hepatitis D (forårsaget af delta virus) ikke forekommer, når hepatitis B infektion er fraværende.
English: Hexyon can be given at the same time as other vaccines such as pneumococcal vaccines, measlesmumps-rubella vaccines, rotavirus vaccines or meningococcal vaccines.
Danish: Hexyon kan gives samtidigt med andre vacciner, f.eks. pneumokok-vacciner, MFR-vacciner (mod mæslinger, fåresyge og røde hunde), rotavirus-vacciner og meningokok-vacciner.