FrancophonIA/ELRC3.0 huggingface dataset:
English: The study involved 402 patients with advanced melanoma with the NRAS Q61 mutation that had spread or could not be removed by surgery.
Danish: Undersøgelsen omfattede 402 patienter med fremskredent melanom med NRAS Q61-mutationen, som havde spredt sig, eller som ikke kunne fjernes ved operation.
English: By blocking the MEK proteins, Balimek is expected to slow down the growth of melanoma cells.
Danish: Balimek forventedes at virke ved at bremse melanomcellernes vækst gennem blokering af MEK-enzymerne.
English: How does Balimek work?
Danish: Hvordan virker Balimek?
English: 1 ml (100 mg/ml) 2 pre-filled syringes
Danish: 2 fyldte injektionssprøjter
English: Immediate Packaging
Danish: 1 fyldt injektionssprøjte
English: Intravenous (not otherwise specified)
Danish: Intravenøst (hvis andet ikke er specificeret)
English: DK-2100 Copenhagen Ø Denmark
Danish: DK-2100 Copenhagen Ø Danmark
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway injection
Danish: Novartis Norge AS Postboks 237 Okern 0510 Oslo Norway
English: CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung 500 mg
Danish: CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung
English: The full EPAR for Capecitabine SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Capecitabine SUN 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 Capecitabine SUN on 21 June 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Capecitabine SUN den 21. juni 2013.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine SUN.
Danish: Dette er et sammendrag af den offentlige europæiske vurderingsrapport (EPAR) for Capecitabine SUN.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Danish: Det tages som tabletter, mens 5-FU normalt må gives ved indsprøjtning.
English: It can only be obtained with a prescription and must be prescribed by a doctor who is experienced in the use of anticancer medicines.
Danish: Det udleveres kun efter recept og må kun ordineres af en læge med erfaring i anvendelse af lægemidler mod kræft.
English: A risk management plan has been developed to ensure that Capecitabine SUN is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Capecitabine SUN anvendes så sikkert som muligt.
English: As a result, it blocks the growth of tumour cells and eventually kills them.
Danish: Derved blokeres væksten af kræftcellerne, der til sidst dør.
English: The doctor will calculate the number of 150- and 500-mg tablets the patient needs to take.
Danish: Lægen beregner det antal tabletter på 150 mg og 500 mg, som patienten skal tage.
English: Capecitabine SUN tablets should be swallowed with water within the 30 minutes after a meal.
Danish: Capecitabine SUN-tabletterne sluges hele med vand inden for 30 minutter efter et måltid.
English: Capecitabine SUN is taken twice a day at doses between 625 and 1,250 mg per square metre body surface area (calculated using the patient's height and weight).
Danish: Capecitabine SUN tages to gange dagligt i doser mellem 625 og 1 250 mg pr. kvadratmeter legemsoverflade (beregnet ud fra patientens højde og vægt).
English: Capecitabine SUN is available as tablets (150 and 500 mg).
Danish: Capecitabine SUN fås som tabletter (150 og 500 mg).
English: The Committee recommended that Capecitabine SUN be approved for use in the EU.
Danish: Udvalget anbefalede, at Capecitabine SUN godkendes til anvendelse i EU.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, mainly in tumour cells.
Danish: Capecitabin er et "prodrug" (et forstadium), der omdannes til 5-fluoruracil (5FU) i kroppen, hovedsageligt i svulstcellerne.
English: capecitabine
Danish: capecitabin
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Capecitabine SUN has been shown to have comparable quality and to be bioequivalent to Xeloda.
Danish: Agenturets Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Capecitabine SUN er af sammenlignelig kvalitet og er bioækvivalent med Xeloda.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Capecitabine SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Capecitabine SUN, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Capecitabine SUN is a ‘generic medicine'.
Danish: Capecitabine SUN er et "generisk lægemiddel".
English: This means that Capecitabine SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Xeloda.
Danish: Det betyder, at Capecitabine SUN er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Xeloda.
English: What measures are being taken to ensure the safe and effective use of Capecitabine SUN?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Capecitabine SUN?
English: Capecitabine SUN is used with or without other anticancer medicines;
Danish: Capecitabine SUN anvendes med eller uden andre lægemidler mod kræft
English: What are the benefits and risks of Capecitabine SUN?
Danish: Hvilke fordele og risici er der forbundet med Capecitabine SUN?
English: For more information about treatment with Capecitabine SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Capecitabine SUN, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Capecitabine SUN
Danish: Andre oplysninger om Capecitabine SUN
English: Capecitabine SUN is used with or without other anticancer medicines in patients who have had surgery for ‘stage III' or ‘Dukes' stage C' colon cancer;
Danish: Capecitabine SUN anvendes med eller uden andre lægemidler mod kræft til patienter, der er opereret for tyktarmskræft i "stadium III" eller "Dukes' stadium C"
English: • advanced gastric (stomach) cancer.
Danish: • fremskreden gastrisk cancer (mavekræft).
English: Because Capecitabine SUN 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 Capecitabine SUN er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Capecitabine SUN, capecitabine, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group ‘anti-metabolites'.
Danish: Det aktive stof i Capecitabine SUN, capecitabin, er et cytotoksisk lægemiddel (et lægemiddel, som dræber celler, der deler sig, såsom kræftceller) og tilhører gruppen af "antimetabolitter" (stofskiftehæmmere).
English: Because Capecitabine SUN is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Xeloda.
Danish: Da Capecitabine SUN er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Xeloda.
English: • colon (large bowel) cancer.
Danish: • koloncancer (tyktarmskræft).
English: For practical information about using Capecitabine SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Capecitabine SUN, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Capecitabine SUN and what is it used for?
Danish: Hvad er Capecitabine SUN, og hvad anvendes det til?
English: Capecitabine SUN is an anticancer medicine that contains the active substance capecitabine.
Danish: Capecitabine SUN er et lægemiddel mod kræft, der indeholder det aktive stof capecitabin.
English: It is not intended to provide practical advice on how to use Capecitabine SUN.
Danish: Det er ikke en praktisk vejledning i, hvordan Capecitabine SUN bør anvendes.
English: Capecitabine SUN is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Danish: Capecitabine SUN anvendes her sammen med docetaxel (et andet lægemiddel mod kræft), hvis behandling med antracykliner (en anden form for lægemiddel mod kræft) ikke har virket.
English: Capecitabine SUN is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Danish: Capecitabine SUN anvendes sammen med andre lægemidler mod kræft, herunder et platinholdigt kræftmiddel såsom cisplatin
English: Why has Capecitabine SUN been approved?
Danish: Hvorfor er Capecitabine SUN blevet godkendt?
English: How has Capecitabine SUN been studied?
Danish: Hvordan er Capecitabine SUN blevet undersøgt?
English: How is Capecitabine SUN used?
Danish: Hvordan anvendes Capecitabine SUN?
English: How does Capecitabine SUN work?
Danish: Hvordan virker Capecitabine SUN?
English: 31 March 2016
Danish: Den 31. marts 2016
English: This section should also include literature case reports and review.
Danish: Dette afsnit skal også indeholde case-rapporter og en oversigt.
English: Annex IV Conditions to the marketing authorisations
Danish: Bilag IV Betingelser for markedsføringstilladelserne
English: • discuss the usage in elderly, taking into account the naturally lower level of testosterone in this age group of patients.
Danish: • drøfte anvendelsen hos ældre under hensyntagen til det naturligt lavere niveau af testosteron hos denne aldersgruppe.
English: Furthermore the discussion on the adverse events in this group should be compared with the pattern of adverse events in other age groups.
Danish: Desuden skal drøftelsen af bivirkninger hos denne gruppe sammenlignes med bivirkningsmønsteret hos andre aldersgrupper
English: The spontaneous reports shall not be presented as a listing of the individual cases, but rather as a general discussion of the aggregated cases, and include all relevant information, e.g. time to onset (when available), haematocrit/haemoglobin level (when available), indication, age, confounding factors and other.
Danish: De spontane indberetninger skal ikke fremlægges som en liste over enkelttilfælde, men som en generel diskussion af de indsamlede tilfælde, og skal indeholde alle relevante oplysninger, f.eks. tid til indsætten (hvis den foreligger), hæmatokrit-/hæmoglobinniveau (hvis den foreligger), indikation, alder, konfunderende faktorer m.v.
English: The Marketing Authorisation Holders of testosterone-containing medicinal products should, with the next PSUR:
Danish: Indehaverne af markedsføringstilladelserne for lægemidler indeholdende testosteron skal i den næste PSUR:
English: • submit the PSUR within 90 days following the DLP of 31 December
Danish: • indsende PSUR'en senest 90 dage efter dataafskæringspunktet den 31. december 2015.
English: • discuss a possible mechanism of VTE and the potential association between CV/VTE events and testosterone levels (whether low or high levels compared to eugonadal level may contribute to the risk), and discuss if the information should be included in the product information.
Danish: • drøfte en mulig mekanisme for VTE og den potentielle sammenhæng mellem CV/VTE-hændelser og koncentrationen af testosteron (hvorvidt lav eller høj koncentration i forhold til det eugonadale niveau kan medvirke til risikoen) og drøfte, om disse oplysninger bør medtages i produktinformationen
English: • monitor cardiovascular risk (including literature review, clinical trials data and all other relevant data) and discuss the finding in the next PSUR.
Danish: • overvåge den kardiovaskulære risiko (herunder gennemgang af litteraturen, data fra kliniske undersøgelser og alle andre relevante data) og drøfte resultaterne i den næste PSUR
English: • report on venous thrombolic events (VTE) including deep venous thrombosis (VTE) and pulmonary embolism (PE) in a separate section in the next PSUR.
Danish: • indberette venøse tromboemboliske hændelser (VTE), herunder dyb venetrombose (VTE) og lungeødem (PE) i et separat afsnit i den næste PSUR.
English: National competent authorities of Member State(s) or reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten/-staterne eller i givet fald i referencemedlemsstaten/-staterne sikrer, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: The effect of each infusion lasts for a year or more.
Danish: Virkningen af hver infusion varer et år eller længere.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere information findes i sammenfatningen af risikohåndteringsplanen.
English: Patients must have adequate fluids before and after treatment, and should receive adequate supplements of vitamin D and calcium.
Danish: Patienten skal have tilstrækkelig væske før og efter behandlingen og skal have passende tilskud af vitamin D og calcium.
English: The full EPAR and risk management plan summary for Zoledronic acid Teva Generics can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for generiske lægemidler svarende til Zoledronsyre Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In Paget's disease, the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Danish: Ved Pagets sygdom nedbrydes knoglevævet hurtigere, og når det gendannes, er det svagere end normalt.
English: This can be repeated once a year in patients being treated for osteoporosis.
Danish: Dette kan gentages en gang om året hos patienter i behandling for knogleskørhed.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Generics on 27 March 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for generiske lægemidler svarende til Zoledronsyre Teva den 27. marts 2014.
English: Gradually, the bones become thin and fragile, and more likely to fracture.
Danish: Knoglerne bliver derved efterhånden tynde og skrøbelige og er mere udsat for brud.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Danish: Knogleskørhed opstår, når der ikke dannes tilstrækkelig ny knogle til at erstatte den, der nedbrydes naturligt.
English: This is a disease where the normal process of bone growth is altered.
Danish: Ved denne sygdom er den normale knoglevækst ændret.
English: It is used in patients who are at risk of fractures (broken bones) and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Danish: De anvendes hos patienter med risiko for knoglebrud (fraktur) og hos patienter med knogleskørhed som følge af langvarig behandling med steroider af typen binyrebarkhormoner.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Generics.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for generiske lægemidler svarende til Zoledronsyre Teva.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Generics is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at generiske lægemidler svarende til Zoledronsyre Teva anvendes så risikofrit som muligt.
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Aclasta.
English: This leads to less bone loss in osteoporosis and less disease activity in Paget's disease.
Danish: Dette mindsker knogletabet ved knogleskørhed og nedsætter sygdomsaktiviteten ved Pagets sygdom.
English: No additional studies were needed as Zoledronic acid Teva Generics is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Danish: Der var ikke brug for yderligere undersøgelser, da generiske lægemidler svarende til Zoledronsyre Teva gives ved infusion og indeholder samme aktive stof som referencelægemidlet Aclasta.
English: In the treatment of Paget's disease, Zoledronic acid Teva Generics must only be used by a doctor who has experience in the treatment of the disease.
Danish: Til behandling af Pagets sygdom må generiske lægemidler svarende til Zoledronsyre Teva kun gives af en læge med erfaring i behandling af sygdommen.
English: Zoledronic acid Teva Generics is given as an infusion lasting at least 15 minutes.
Danish: Generiske lægemidler svarende til Zoledronsyre Teva gives som en infusion, der varer mindst 15 minutter.
English: For more information about treatment with Zoledronic acid Teva Generics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med generiske lægemidler svarende til Zoledronsyre Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Danish: Knogleskørhed kan forekomme hos begge køn som bivirkning af behandlingen med binyrebarkhormon.
English: Because Zoledronic acid Teva Generics is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da generiske lægemidler svarende til Zoledronsyre Teva er generiske lægemidler, antages de at have de samme fordele og risici som referencelægemidlet.
English: The active substance in Zoledronic acid Teva Generics, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i generiske lægemidler svarende til Zoledronsyre Teva, zoledronsyre, er et bifosfonat.
English: This means that Zoledronic acid Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Danish: At generiske lægemidler svarende til Zoledronsyre Teva er “generiske”, betyder, at de svarer til et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU).
English: Zoledronic acid Teva Generics is a medicine that contains zoledronic acid (5mg).
Danish: Generiske lægemidler svarende til Zoledronsyre Teva er lægemidler, der indeholder zoledronsyre (5 mg).
English: Zoledronic acid Teva Generics is also used to treat Paget's disease of the bone in adults.
Danish: Generiske lægemidler svarende til Zoledronsyre Teva anvendes desuden til behandling af Pagets sygdom hos voksne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zoledronic acid Teva Generics has been shown to be comparable to Aclasta.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) fandt, at generiske lægemidler svarende til Zoledronsyre Teva i overensstemmelse med EU-kravene er påvist at have en kvalitet svarende til Aclasta.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Generics, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for generiske lægemidler svarende til Zoledronsyre Teva er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Generics?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af generiske lægemidler svarende til Zoledronsyre Teva?
English: What is Zoledronic acid Teva Generics and what is it used for?
Danish: Hvad er generiske lægemidler svarende til Zoledronsyre Teva, og hvad anvendes de til?
English: It is not intended to provide practical advice on how to use Zoledronic acid Teva Generics.
Danish: Det er ikke en praktisk vejledning i, hvordan generiske lægemidler svarende til Zoledronsyre Teva bør anvendes.
English: What are the benefits and risks of Zoledronic acid Teva Generics?
Danish: Hvilke fordele og risici er der forbundet med generiske lægemidler svarende til Zoledronsyre Teva?
English: For practical information about using Zoledronic acid Teva Generics, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af generiske lægemidler svarende til Zoledronsyre Teva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Danish: De anvendes til behandling af knogleskørhed (osteoporose) hos kvinder efter overgangsalderen og hos mænd.
English: Zoledronic acid Teva Generics is usually given, but additional infusions can be considered if the patient's disease comes back.
Danish: Til Pagets sygdom gives sædvanligvis kun én infusion af generiske lægemidler svarende til Zoledronsyre Teva, men der kan gives ekstra infusioner, hvis sygdommen vender tilbage.
English: Other information about Zoledronic acid Teva Generics
Danish: Andre oplysninger om generiske lægemidler svarende til Zoledronsyre Teva
English: See the package leaflet for full details.
Danish: Fuldstændige oplysninger herom fremgår af indlægssedlen.
English: Why is Zoledronic acid Teva Generics approved?
Danish: Hvorfor er generiske lægemidler svarende til Zoledronsyre Teva blevet godkendt?
English: The Committee recommended that Zoledronic acid Teva Generics be approved for use in the EU.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse i EU for generiske lægemidler svarende til Zoledronsyre Teva.
English: How has Zoledronic acid Teva Generics been studied?
Danish: Hvordan blev generiske lægemidler svarende til Zoledronsyre Teva undersøgt?
English: Zoledronic acid Teva Generics is available as a solution for infusion (drip) into a vein; the medicine can only be obtained with a prescription.
Danish: Generiske lægemidler svarende til Zoledronsyre Teva leveres som en infusionsvæske, opløsning, der gives med drop i en vene.
English: How does Zoledronic acid Teva Generics work?
Danish: Hvordan virker generiske lægemidler svarende til Zoledronsyre Teva ?
English: Zoledronic acid Teva Generics zoledronic acid
Danish: EPAR - sammendrag for offentligheden generiske lægemidler svarende til Zoledronsyre Teva zoledronsyre
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel skal lægemidlet anvendes straks.
English: Reasons for Failures
Danish: Årsager til failure
English: Unopened vial: 30 months After opening: Use immediately
Danish: Uåbnet hætteglas: 30 måneder Efter åbning: anvendes straks