FrancophonIA/ELRC3.0 huggingface dataset:
English: Nervous system disorders headache dizziness, dysgeusia, paraesthesia, somnolence, tremor, hypoaesthesia
Danish: Svimmelhed, dysgeusi, paræstesi, døsighed, tremor, hypæstesi
English: Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.
Danish: Cancidas 70 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas Cancidas indeholder 70 mg caspofungin.
English: c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml.
Danish: c af rekonstitueret CANCIDAS overføres til en reduceret mængde 0,9%, 0,45% eller 0,225% natriumchloridinfusionsvæske eller Ringer-lactatinfusionsvæske, men den endelige koncentration af infusionsvæsken må ikke overstige 0,5 mg/ml.
English: b
Danish: (m
English: Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin.
Danish: Cancidas 50 mg pulver til koncentrat til infusionsvæske, opløsning Et hætteglas Cancidas indeholder 50 mg caspofungin.
English: CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion
Danish: Cancidas 50 mg pulver til koncentrat til infusionsvæske, opløsning Cancidas 70 mg pulver til koncentrat til infusionsvæske, opløsning caspofungin
English: Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula)
Danish: dosering til børn Før fremstilling af infusionsvæske skal patientens legemsoverfladeareal beregnes ved hjælp af følgende formel: (Mostellerformlen
English: In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/m2 daily dose.
Danish: Hos små børn (12-23 måneder), der fik caspofungin 50 mg/m2 dagligt (max. 70 mg dagligt), var caspofungins AUC0-24t i plasma efter flere doser den samme som hos voksne, der fik caspofungin 50 mg dagligt og som hos større børn (2-11 år), der fik 50 mg/m2 dagligt.
English: Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller Formula)
Danish: dosering til børn Før fremstilling af infusionsvæske skal patientens legemsoverfladeareal beregnes ved hjælp af følgende formel: (Mostellerformlen)
English: Pharmacokinetic data from one 10-month old child receiving the 50 mg/m2 daily dose indicated an AUC0-24 hr within the same range as that observed in older children and adults at the
Danish: Farmakokinetiske data fra ét 10-måneders barn, der fik 50 mg/m2, viste et AUC0-24t, der lå inden for samme område, som det der var set hos større børn og voksne ved henholdsvis 50 mg/m2 og en dosis på 50 mg, mens AUC0-24t hos ét 6-måneders barn, der fik 50 mg/m 2, var noget højere.
English: How to store Cancidas
Danish: Sådan får du Cancidas
English: c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection.
Danish: c rekonstitueret Cancidas til en i.v.-pose (eller flaske) med 250 ml 0,9%, 0,45% eller 0,225% natriumchloridinfusionsvæske eller Ringer-lactatinfusionsvæske.
English: Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: What Cancidas contains
Danish: Cancidas indeholder:
English: CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin
Danish: Cancidas 70 mg pulver til koncentrat til infusionsvæske, opløsning caspofungin
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin
Danish: Cancidas 50 mg pulver til koncentrat til infusionsvæske, opløsning caspofungin
English: If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas.
Danish: Kontakt lægen, sundhedspersonalet eller apoteket, hvis noget af ovenstående gælder for dig (eller du er i tvivl), før du får Cancidas.
English: Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Danish: Fremstilling af 70 mg/m2 infusionsvæske til børn >3 måneder (ved brug af 50-mg hætteglas) Bestem den mætningsdosis, der skal anvendes til barnet, ved hjælp af patientens legemsoverfladeareal (som beregnet ovenfor) og følgende ligning: Legemsoverfladeareal (m2) x 70 mg/m2 = Mætningsdosis
English: Caspofungin
Danish: Dyspnø
English: Ιtalia
Danish: Takykardi
English: CANCIDAS 50 mg powder for concentrate for solution for infusion
Danish: Cancidas 50 mg pulver til koncentrat til infusionsvæske, opløsning
English: CANCIDAS 70 mg powder for concentrate for solution for infusion
Danish: Cancidas 70 mg pulver til koncentrat til infusionsvæske, opløsning
English: Preparation of the 70 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Danish: Fremstilling af 50 mg/m2 infusionsvæske til børn >3 måneder (ved brug af 70-mg hætteglas) Bestem den daglige vedligeholdelsesdosis, der skal anvendes til barnet ved hjælp af patientens legemsoverfladeareal (som beregnet ovenfor) og følgende ligning:
English: Aseptically add 10.5 ml of water for injection.
Danish: Tilsæt aseptisk 10,5 ml vand til injektionsvæsker a. Dette giver en endelig caspofunginkoncentration i hætteglasset på 5,2 mg/ml.
English: Class
Danish: Højde
English: Preparation of the 70 mg/m infusion for paediatric patients >3 months of age (using a 50-mg vial) Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation:
Danish: Fremstilling af 50 mg/m2 infusionsvæke til børn >3 måneder (ved brug af 50-mg hætteglas) Bestem den daglige vedligeholdelsesdosis, der skal anvendes til barnet, ved hjælp af patientens legemsoverfladeareal (som beregnet ovenfor) og følgende ligning:
English: CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
Danish: Hvert hætteglas indeholder 50 mg caspofungin (som acetat).
English: Blood and haemoglobin anaemia, thrombocytopaenia,
Danish: Luftveje, thorax og mediastinum
English: Oral use blister (alu/alu)
Danish: 50 mg/100 mg Filmovertrukne tabletter Oral anvendelse Blister (alu/alu) 28 tabletter
English: The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Danish: Dosis afhænger af patientens alder og tilstand samt reaktionen på behandlingen, men den bør ikke overstige 800 mg dagligt.
English: It is available as capsules (100 and 400 mg) and tablets (100 and 400 mg) and 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: Det fås som kapsler (100 og 400 mg) og tabletter (100 og 400 mg) og gives gennem munden med et måltid og et glas vand for at mindske irritation af mave og tarme.
English: The full EPAR for Imatinib Teva 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 Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva on 8 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Imatinib Tevaden 8. januar 2013.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Danish: Det anvendes også til voksne og børn i den "kroniske fase" af sygdommen, hvis den ikke reagerer på interferon alfa (et andet lægemiddel mod kræft), og i de mere fremskredne faser af sygdommen ("accelereret fase" og "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 kræftcellerne, herunder de receptorer, der medvirker til at stimulere cellerne til at dele sig ukontrolleret.
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: This is a summary of the European public assessment report (EPAR) for Imatinib Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imatinib Teva.
English: This means that Imatinib Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Danish: Det betyder, at Imatinib Teva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Glivec.
English: Other information about Imatinib Teva
Danish: Andre oplysninger om Imatinib Teva
English: Imatinib Teva imatinib
Danish: Imatinib Teva
English: What measures are being taken to ensure the safe and effective use of Imatinib Teva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imatinib Teva?
English: Imatinib Teva is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Danish: Imatinib Teva anvendes, når patienten er "Philadelphiakromosompositiv" (Ph+).
English: By blocking these receptors, Imatinib Teva helps to control cell division.
Danish: Ved at blokere disse receptorer er Imatinib Teva med til at begrænse celledelingen.
English: Imatinib Teva 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.
Danish: imatinib udleveres kun mod recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af patienter med blodkræft.
English: For more information about treatment with Imatinib Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imatinib Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Imatinib Teva contains the active substance imatinib.
Danish: Imatinib Teva indeholder det aktive stof imatinib.
English: Imatinib Teva 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 Teva 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: • myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Danish: • Myelodysplastiske eller myeloproliferative sygdomme (MD/MPD), som er en gruppe af sygdomme, hvor kroppen producerer et stort antal unormale blodlegemer.
English: What is Imatinib Teva and what is it used for?
Danish: Hvad er Imatinib Teva, og hvad anvendes det til?
English: The active substance in Imatinib Teva, imatinib, is a protein-tyrosine kinase inhibitor.
Danish: Det aktive indholdsstof i Imatinib Teva, imatinib, er en protein-tyrosinkinasehæmmer.
English: Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Glivec.
English: Imatinib Teva is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Danish: Imatinib Teva anvendes i kombination 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 Teva?
Danish: Hvilken fordel og risiko er der forbundet med Imatinib Teva?
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Danish: • Dermatofibrosarcoma protuberans (DFSP), en form for kræft (sarkom), hvor cellerne i vævet under huden begynder at dele sig ukontrolleret.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Imatinib Teva i overensstemmelse med EUkravene er påvist at have en kvalitet svarende til Glivec og at være bioækvivalent med dette.
English: Imatinib Teva is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Danish: Imatinib Teva anvendes til behandling af voksne med HES eller CEL, hos hvem der forekommer en særlig-omarrangering af de to gener FIP1L1 og PDGFRα.
English: Imatinib Teva is a cancer medicine.
Danish: Imatinib Teva er et lægemiddel mod kræft.
English: Because Imatinib Teva is a generic medicine, studies in patients have been limited to tests to determine that the tablets and capsules are bioequivalent to the reference medicine, Glivec.
Danish: Da Imatinib Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at tabletterne og kapslerne er bioækvivalente med referencelægemidlet Glivec.
English: Because Imatinib Teva 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 Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is not intended to provide practical advice on how to use Imatinib Teva.
Danish: Det er ikke en praktisk vejledning i, hvordan Imatinib Teva bør anvendes.
English: Imatinib Teva is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Danish: Imatinib Teva anvendes hos voksne og børn, som for nylig har fået diagnosticeret Ph+ CML, og som ikke egner sig til en knoglemarvstransplantation.
English: For practical information about using Imatinib Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Imatinib Teva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Danish: • Ph+ akut lymfoblastisk leukæmi (ALL), en kræftform, hvor lymfocytterne (en anden form for hvide blodlegemer) formerer sig for hurtigt.
English: The Committee recommended that Imatinib Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Imatinib Teva.
English: Why is Imatinib Teva approved?
Danish: Hvorfor blev Imatinib Teva godkendt?
English: Imatinib Teva is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Danish: Imatinib Teva anvendes til behandling af voksne med MD/MPD, hos hvem genet for blodpladederiveret vækstfaktorreceptor (PDGFR) har omarrangeret sig
English: • 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: • Fremskredent hypereosinofilt syndrom (HES) eller kronisk eosinofil leukæmi (CEL), som er sygdomme, hvor eosinofiler (en anden form for hvide blodlegemer) begynder at vokse ukontrolleret.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Teva 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 Teva.
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), en form for kræft, som angriber de hvide blodlegemer, hvori der er granulocytter (en form for hvide blodlegemer), som begynder at vokse ukontrolleret.
English: How has Imatinib Teva been studied?
Danish: Hvordan blev Imatinib Teva undersøgt?
English: How is Imatinib Teva used?
Danish: Hvordan anvendes Imatinib Teva?
English: How does Imatinib Teva work?
Danish: Hvordan virker Imatinib Teva?
English: EU - Number Invented name
Danish: EU - Nummer Særnavn Styrke
English: This summary was last updated in 09-2012.
Danish: Dette sammendrag blev sidst ajourført i 09-2012.
English: It is available as an oral suspension.
Danish: Det leveres som en oral suspension.
English: This prevents the cells from dividing.
Danish: Dette forhindrer cellerne i dele sig.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xaluprine on 9 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xaluprine den 9. marts 2012.
English: It must also not be used at the same time as patients are having a yellow fever vaccination.
Danish: Det må heller ikke anvendes samtidig med, at patienten bliver vaccineret mod gul feber.
English: The CHMP also noted that the risks of using the medicine are well known.
Danish: CHMP konstaterede desuden, at risiciene ved anvendelse af lægemidlet er velkendte.
English: Treatment with this medicine should be supervised by a healthcare professional experienced in treating patients with ALL.
Danish: Behandlingen med dette lægemiddel bør overvåges af en sundhedsperson med erfaring i behandling af patienter med ALL.
English: This is a summary of the European public assessment report (EPAR) for Xaluprine.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xaluprine.
English: Because the number of patients with ALL is low, the disease is considered ‘rare', and Xaluprine was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Danish: Da antallet af patienter med ALL er lavt, betragtes sygdommen som ”sjælden”, og Xaluprine blev udpeget som ”lægemiddel til sjældne sygdomme” den 30. april 2009.
English: In ALL the lymphocytes multiply too quickly and live for too long.
Danish: Ved ALL formerer lymfocytterne sig for hurtigt og lever i for lang tid.
English: It can be taken with food (except dairy products) or on an empty stomach but this should be consistent from day to day.
Danish: Lægemidlet kan enten tages sammen med et måltid (dog ikke mejeriprodukter) eller på tom mave, når blot det sker på samme måde hver dag.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xaluprine.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Xaluprine.
English: The effectiveness of 6-mercaptopurine in slowing down the progression of ALL is already well known since it has been used for many years.
Danish: Effektiviteten af 6-mercaptopurin til at bremse ALL er allerede velkendt, da det har været anvendt i mange år.
English: The Committee considered that an oral suspension allows more accurate dosing and is more convenient for children unable to swallow tablets.
Danish: Udvalget fandt, at en oral suspension giver mulighed for mere nøjagtig dosering og er behageligere for børn, der ikke kan synke tabletter.
English: The Committee concluded that the benefits of Xaluprine are greater than its risks and recommended that it be granted marketing authorisation.
Danish: Udvalget konkluderede, at fordelene ved Xaluprine overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Because 6-mercaptopurine has been used for the treatment of ALL in the European Union for a number of years in the tablet form, the company presented results from the scientific literature of studies previously carried out with mercaptopurine tablets.
Danish: Da 6-mercaptopurin i tabletform har været anvendt til behandling af ALL i en årrække i EU, fremlagde virksomheden resultater fra den videnskabelige litteratur af de undersøgelser, der tidligere er udført med mercaptopurin som tabletter.
English: For more information about treatment with Xaluprine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xaluprine, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Xaluprine is a medicine that contains the active substance mercaptopurine.
Danish: Xaluprine er et lægemiddel, der indeholder det aktive stof mercaptopurin.
English: In the body, 6-mercaptopurine is converted within cells into a substance that interferes with the production of new DNA.
Danish: I organismen omdannes 6-mercaptopurin i cellerne til et stof, der griber ind i dannelsen af nyt dna.
English: The full EPAR for Xaluprine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Xaluprine findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The bioavailability study compared the way the two different forms of the same medicine are absorbed in the human body and the levels of the active substance they produce.
Danish: I biotilgængelighedsundersøgelsen blev de to former af lægemidlet sammenlignet med hensyn til den måde, de optages i kroppen på, og den koncentration af det aktive stof, de bevirker.
English: The most common side effects with mercaptopurine (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts) and thrombocytopenia (low blood platelet counts).
Danish: De almindeligste bivirkninger ved mercaptopurin (som ses hos flere end 1 ud af 10 patienter) er leukopeni (for lavt antal hvide blodlegemer) og trombocytopeni (for lavt antal blodplader).
English: Medicines containing mercaptopurine in tablet form have been already used in the EU for many years to treat patients with ALL.
Danish: I EU er lægemidler indeholdende mercaptopurin i tabletform allerede i mange år blevet anvendt til behandling af ALL.