FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Imatinib medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Imatinib medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Danish: Det betyder, at nogle af patientens gener har omarrangeret sig, så de danner et specielt kromosom, der kaldes Philadelphiakromosomet.
English: • Adults with Ph+ CML in blast crisis;
Danish: • Voksne med Ph+ CML i blastkrise.
English: These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Danish: Disse enzymer findes i visse receptorer i visse kræftceller receptorer, der medvirker til at stimulere cellerne til at dele sig ukontrolleret.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Danish: Det udleveres kun efter recept, og behandlingen bør ordineres og iværksættes af en læge med erfaring i behandling af patienter med blodkræft eller faste svulster.
English: It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Danish: Det anvendes desuden til børn, hos hvem sygdommen er i “kronisk fase” og ikke reagerer på interferon alfa (et andet lægemiddel mod kræft) samt i mere fremskredne faser af sygdommen (“accelereret fase” og “blastkrise”).
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Flere oplysninger om generiske lægemidler med spørgsmål og svar kan du finde her.
English: This is a summary of the European public assessment report (EPAR) for Imatinib medac.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imatinib medac.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 25. september 2013.
English: Imatinib medac is available as capsules (100 and 400 mg).
Danish: Imatinib medac leveres som kapsler (100 og 400 mg).
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Danish: Det anvendes desuden alene hos voksne til behandling af Ph+ ALL ved tilbagefald af sygdommen efter forudgående behandling eller når sygdommen ikke reagerer på andre lægemidler.
English: A risk management plan has been developed to ensure that Imatinib medac is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Imatinib medac anvendes så risikofrit som muligt.
English: This means that Imatinib medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Danish: Det betyder, at Imatinib medac er identisk med et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU).
English: By blocking these receptors, Imatinib medac helps to control cell division.
Danish: Ved at blokere disse receptorer bremser Imatinib medac cellernes deling.
English: Imatinib medac is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Danish: Imatinib medac anvendes til behandling af voksne med DFSP, der ikke kan fjernes ved operation, og til voksne, som er uegnede til operation, når der er tilbagefald af kræften efter behandling, eller når den har bredt sig til andre dele af kroppen.
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer enzymer af typen tyrosinkinaser.
English: Imatinib medac is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Danish: Imatinib medac anvendes, når patienten er “Philadelphia-kromosom-positiv” (Ph+).
English: Imatinib medac 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 medac gives gennem munden sammen med et måltid og et stort glas vand for at mindske risikoen for irritation af mave-tarmkanalen.
English: For more information about treatment with Imatinib medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imatinib medac, 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 Imatinib medac?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imatinib medac?
English: • Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Danish: • Voksne med myelodysplastiske eller myeloproliferative sygdomme (MD/MPD), som er en gruppe sygdomme, hvor kroppen producerer store mængder unormale blodlegemer.
English: The active substance in Imatinib medac, imatinib, is a protein-tyrosine kinase inhibitor.
Danish: Det aktive indholdsstof i Imatinib medac, imatinib, er en protein-tyrosinkinasehæmmer.
English: • Adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Danish: • Voksne med dermatofibrosarcoma protuberans (DFSP), som er en kræfttype (sarkom), hvor cellerne i vævet under huden deler sig ukontrolleret.
English: Imatinib medac is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Danish: Imatinib medac anvendes til behandling af voksne med HES eller CEL, hos hvem der forekommer en særlig omarrangering af de to gener FIP1L1 og PDGFRα.
English: What are the benefits and risks of Imatinib medac?
Danish: Hvilke fordele og risici er der forbundet med Imatinib medac?
English: Imatinib medac is a ‘generic medicine'.
Danish: Imatinib medac er et “generisk lægemiddel”.
English: Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL.
Danish: Imatinib medac anvendes i kombination med andre kræftlægemidler til patienter, som for nylig har fået diagnosticeret Ph+ ALL.
English: Imatinib medac is an anticancer medicine that contains the active substance imatinib.
Danish: Imatinib medac er et kræftlægemiddel, der indeholder det aktive stof imatinib.
English: Other information about Imatinib medac
Danish: Andre oplysninger om Imatinib medac
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac has been shown to have comparable quality and to be bioequivalent to Glivec.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Imatinib medac i overensstemmelse med EUkravene er påvist at have en kvalitet svarende til Glivec og at være bioækvivalent med dette.
English: Because Imatinib medac 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 medac er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Danish: fandt derfor, at fordelene er større end risiciene, ligesom for Glivec.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Imatinib medac er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: It is not intended to provide practical advice on how to use Imatinib medac.
Danish: Det er ikke en praktisk vejledning i, hvordan Imatinib medac bør anvendes.
English: Imatinib medac is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Danish: Imatinib medac anvendes hos børn, som for nylig har fået diagnosticeret Ph+ CML og ikke er egnede til en knoglemarvstransplantation.
English: What is Imatinib medac and what is it used for?
Danish: Hvad er Imatinib medac, og hvad anvendes det til?
English: • Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Danish: • Voksne og børn med Ph+ akut lymfoblastisk leukæmi (ALL), der er en kræftform, hvor hvide blodlegemer af en anden type (lymfocytter) formerer sig for hurtigt.
English: For practical information about using Imatinib medac, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Imatinib medac, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because Imatinib medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Danish: Da Imatinib medac er et generisk lægemiddel, er der udelukkende udført undersøgelser til at fastlægge, at det er bioækvivalent med referencelægemidlet Glivec.
English: Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Danish: Imatinib medac anvendes til behandling af voksne med MD/MPD, hos hvem genet for blodpladederiveret vækstfaktorreceptor (PDGFR) har omarrangeret sig.
English: • Adults with advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Danish: • Voksne med fremskredent hypereosinofilt syndrom (HES) eller kronisk eosinofil leukæmi (CEL), som er sygdomme, hvor hvide blodlegemer af endnu en anden type (eosinofile) begynder at vokse ukontrolleret.
English: Why is Imatinib medac approved?
Danish: Hvorfor er Imatinib medac blevet godkendt?
English: • Children with 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: • Børn med kronisk myeloid leukæmi (CML), der er en form for blodkræft, hvor hvide blodlegemer af en bestemt type (granulocytter) begynder at vokse ukontrolleret.
English: The Committee recommended that Imatinib medac be approved for use in the EU.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Imatinib medac.
English: How has Imatinib medac been studied?
Danish: Hvordan blev Imatinib medac undersøgt?
English: How does Imatinib medac work?
Danish: Hvordan virker Imatinib medac?
English: How is Imatinib medac used?
Danish: Hvordan anvendes Imatinib medac?
English: Batch: {number}
Danish: Batch: {nummer}
English: Allergic-type reactions are rare.
Danish: Allergilignende reaktioner er sjældne.
English: EXP: {month/year}
Danish: EXP: {måned/år}
English: ATC vet code : QI07AO01.
Danish: ATCvet-kode: QI07AO01.
English: Vaccination induces a cell-mediated immunity evidenced by:
Danish: Vaccinationen inducerer en cellemedieret immunitet, der er påvist af:
English: In rare cases anorexia and emesis have been reported.
Danish: I sjældne tilfælde har anorexi og emesis været set.
English: Vaccination should not prevent other measures taken to reduce exposure to sandflies.
Danish: Vaccination bør ikke udelukke andre foranstaltninger mod eksponering for sandfluer.
English: The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Danish: Vaccinens indvirkning på folkesundheden og kontrol af menneskelige infektioner kan ikke vurderes ud fra de tilgængelige data.
English: Any person intending to import, sell, supply and/or use CaniLeish must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
Danish: Enhver person, som har til hensigt at indføre, sælge, levere og/eller anvende CaniLeish, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden indførsel, salg, levering og/eller anvendelse finder sted.
English: In very rare cases a more severe reaction at the injection site (injection site necrosis, vasculitis) has been reported.
Danish: I meget sjældne tilfælde er der rapporteret om en mere alvorlig reaktion på injektionsstedet (nekrose i injektionssted, vasculitis).
English: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: The efficacy of vaccination in dogs already infected has not been investigated and therefore cannot be recommended.
Danish: Vaccinens virkning på hunde, der allerede er inficerede, er ikke blevet undersøgt og kan derfor ikke anbefales.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSISR
English: b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Danish: b) at den sygdom, som lægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: Pharmacotherapeutic group: Immunologicals for canidae - dog - inactivated parasitic vaccine.
Danish: Farmakoterapeutisk gruppe: Immunologisk præparat til canidae - hund - inaktiveret parasitisk vaccine.
English: Each dose of 1 ml vaccine contains:
Danish: Hver dosis vaccine svarende til 1 ml indeholder:
English: In very rare cases, serious hypersensitivity reactions have been observed which could be fatal.
Danish: I meget sjældne tilfælde har alvorlige overfølsomhedsreaktioner, som kan være fatale, været set.
English: In areas of low or no infection pressure a benefit/risk assessment must be undertaken by the veterinarian before deciding to use the vaccine in dogs.
Danish: I områder med lavt eller intet infektionstryk skal dyrlægen vurdere risk-benefitforholdet, før det afgøres om vaccinen skal anvendes på hunde.
English: Vaccinate only healthy animals.
Danish: Kun raske dyr bør vaccineres.
English: • a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
Danish: • En T-cellelymfoproliferation med sekretion af interferon-gamma cytokiner,
English: Common (more than 1 but less than 10 animals in 100 animals), Uncommon (more than 1 but less than 10 animals in 1,000 animals), Rare (more than 1 but less than 10 animals in 10,000 animals), Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: Antibodies due to vaccination can be differentiated from antibodies due to natural infection by using a rapid diagnostic serological test as a first step to a differential diagnosis.
Danish: Antistoffer, der dannes på grund af vaccination, kan differentieres fra antistoffer, der dannes på grund af naturlig infektion, ved brug af en hurtig serologisk diagnostisk test som første trin til en differentialdiagnose.
English: Sodium chloride Water for injections
Danish: Natriumklorid Vand til injektion
English: For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.
Danish: Aktiv immunisering af Leishmania-negative hunde fra 6-måneders alderen for at reducere risikoen for udvikling af en aktiv infektion og klinisk sygdom efter kontakt med Leishmania infantum.
English: Onset of immunity: 4 weeks after the primary vaccination course.
Danish: Opnåelse af immunitet: 4 uger efter det primære vaccinationsprogram.
English: CaniLeish solvent
Danish: CaniLeish solvens
English: Sodium chloride 9 mg/ml (0.9%)
Danish: Natriumklorid 9 mg/ml (0,9 %)
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG.
English: Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination.
Danish: Transitoriske antistoffer mod Leishmania, der registreres ved en immunofluorescens-antistoftest (IFAT), kan fremkomme efter vaccination.
English: • an enhancement of the leishmanicidal activity of the macrophages,
Danish: • En forbedring af makrofagernes leishmaniacide aktivitet,
English: Duration of immunity: 1 year after the last (re-)vaccination.
Danish: Varighed af immunitet: 1 år efter den sidste (gen-)vaccination.
English: • a positive T-cell-mediated immune response, directed against the Leishmanian antigen (skin test).
Danish: • Et positivt T-cellemedieret immunrespons rettet mod Leishmania-antigenet (hudtest).
English: The efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Danish: Vaccinens effektivitet er demonstreret hos hunde, der har været udsat for flere naturlige parasiteksponeringer i områder med højt infektionstryk.
English: After injection, moderate and transient local reactions such as swelling, nodule, pain on palpation or erythema are common, but these reactions resolve spontaneously within 2 to 15 days.
Danish: Efter injektion er en moderat og forbigående lokal reaktion i form af hævelse, knudedannelse, smerte ved palpation eller erytem almindeligt forekommende, men disse reaktioner forsvinder spontant inden for 2 til 15 dage.
English: Store and transport refrigerated (2 C - 8 C).
Danish: Opbevares og transporteres nedkølet (2 C - 8 C).
English: Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid
Danish: Lyofilisat: Beige frysetørret fraktion Solvens: Farveløs væske
English: Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Danish: Opbevaringstid efter første åbning af den indre emballage: anvendes umiddelbart efter opløsning.
English: Solvent: Sodium chloride solution 9 mg/ml (0.9%)
Danish: Solvens: Natriumkloridopløsning 9 mg/ml (0,9 %)
English: De-worming of infested dogs prior to vaccination is recommended.
Danish: Ormebehandling af angrebne hunde anbefales forud for vaccination.
English: Annual re-vaccination: - One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
Danish: Årlig genvaccination: - En revaccination med en enkelt dosis bør indgives 1 år efter den tredje injektion og herefter en gang årligt.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: • the appearance of specific IgG2 antibodies to Leishmania infantum excreted secreted proteins,
Danish: • Tilsynekomst af specifikke IgG2-antistoffer mod Leishmania infantum sekreterede proteiner (ESP),
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Danish: Efter rekonstitution af lyofilisat og solvens rystes blandingen let, og en dosis på 1 ml administreres subkutant umiddelbart efter ifølge nedenstående vaccinationsplan: Primær vaccinationsprogram: - Første dosis fra 6 måneders alderen, - Anden dosis 3 uger senere, - Tredje dosis 3 uger efter anden injektion.
English: Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg Adjuvant:
Danish: Leishmania infantum sekreterede proteiner (ESP) mindst 100 µg Adjuvans:
English: EXP: {month/year} Use immediately after reconstitution.
Danish: EXP: {måned/år} Produktet anvendes umiddelbart efter opløsning.
English: Other transient signs seen following vaccination such as hyperthermia, apathy and digestive disorders lasting 1 to 6 days are common.
Danish: Andre forbigående symptomer i form af hypertermi, apati og fordøjelsesforstyrrelser, der varer fra 1 til 6 dage, er almindeligt forekommende.
English: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Danish: Primær vaccinationsprogram: - Første dosis fra 6-måneders alderen, - Anden dosis 3 uger senere, - Tredje dosis 3 uger efter anden injektion.
English: Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Danish: Virkningsdata har vist at en vaccineret hund har 3,6 gange mindre risiko for at udvikle en aktiv infektion, og 4 gange mindre risiko for at udvikle en klinisk sygdom end en ikke-vaccineret hund.
English: The import, sale, supply and/or use of CaniLeish is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Danish: Indførsel, salg, levering og/eller anvendelse af CaniLeish er eller kan være forbudt i visse medlemsstater på dele af eller hele deres område.
English: CaniLeish lyophilisate
Danish: CaniLeish lyofilisat
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double-dose of the vaccine.
Danish: Der er ikke observeret bivirkninger udover de i afsnit 4.6 nævnte efter indgivelse af en dobbelt dosis af vaccinen.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de(t) aktive stof(fer), adjuvans(er) eller et eller flere af hjælpestofferne.
English: L. infantum Proteins (ESP) ≥ 100 µg
Danish: L. infantum proteiner (ESP) ≥ 100 µg
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the vaccination schedule.
Danish: Efter rekonstitution af lyofilisat og solvens rystes blandingen let, og en dosis på 1 ml administreres subkutant umiddelbart efter ifølge vaccinationsplanen.