FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may also need to take calcium and vitamin D supplements if they do not have enough from their diet. Preotact can be used for up to 24 months, after which patients can be treated with a bisphosphonate (a medicine that reduces bone loss).
Danish: Preotact kan anvendes i op til 24 måneder, hvorefter patienterne kan behandles med et bisphosphonat (et lægemiddel, som mindsker tabet af knoglemasse).
English: Why has Preotact been approved?
Danish: Hvorfor er Preotact blevet godkendt?
English: How has Preotact been studied?
Danish: Hvordan blev Preotact undersøgt?
English: What benefit has Preotact shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Preotact?
English: What is Preotact?
Danish: Hvad er Preotact?
English: • with unexplained high levels of alkaline phosphatase (an enzyme),
Danish: • med forhøjet alkalisk phosphatase (et enzym) af ukendte årsager, • som har nedsat nyre- eller leverfunktion
English: How is Preotact used?
Danish: Hvordan anvendes Preotact?
English: It is also available as a pre-filled pen incorporating the cartridge containing the powder and solvent Each cartridge contains 14 doses.
Danish: Det fås også som en fyldt injektionssprøjte, der indeholder cylinderampullen med pulveret og opløsningen.
English: EMA/619580/2012 EMEA/H/C/002568
Danish: EMEA/H/C/002568
English: This summary was last updated in 06-2012.
Danish: Dette sammendrag blev sidst ajourført i november 2012.
English: It is used to treat:
Danish: Det anvendes ved:
English: The dose depends on the type of cancer being treated.
Danish: Dosis afhænger af, hvilken form for kræft der behandles.
English: Treatment is continued for six months after colon surgery.
Danish: Behandlingen fortsættes i seks måneder efter tyktarmsoperationen.
English: For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Danish: Til andre former for kræft bringes behandlingen til ophør, hvis sygdommen forværres, eller hvis patienten ikke kan tåle behandlingen.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes også på agenturets websted.
English: The full EPAR for Capecitabine 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 Capecitabine Medac findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pyrimidine is part of the genetic material of cells (DNA and RNA).
Danish: Pyrimidiner er en del af cellernes genetiske materiale (dna og rna).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Medac on 19 November 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Capecitabine Medac den 19. november 2012.
English: It is taken as tablets, while 5-FU normally needs to be injected.
Danish: Det tages som tabletter, mens 5-FU sædvanligvis må gives ved indsprøjtning.
English: As a result, it stops the growth of tumour cells and eventually kills them.
Danish: Derved stoppes væksten af kræftcellerne, der til sidst dør.
English: For more information on generic and hybrid medicines, see the questionand-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske og hybride lægemidler i dokumentet med spørgsmål og svar her.
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 Capecitabine Medac.
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 Capecitabine Medac.
English: Capecitabine Medac 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 Medac tages to gange dagligt i doser mellem 625 og 1 250 mg pr. kvadratmeter legemsoverflade (beregnet ud fra patientens højde og vægt).
English: This means that it is similar to a ‘reference medicine', but it contains capecitabine at a new strength in addition to existing strengths.
Danish: Det betyder, at det er identisk med et ”referencelægemiddel”, men indeholder capecitabin i en ny styrke i tillæg til de eksisterende styrker.
English: It is available as tablets (150, 300 and 500 mg).
Danish: Det fås som tabletter (150, 300 og 500 mg).
English: 5-FU is an analogue of pyrimidine.
Danish: 5-FU er en pyrimidinanalog.
English: This is a summary of the European public assessment report (EPAR) for Capecitabine Medac.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Capecitabine Medac.
English: Capecitabine Medac tablets should be swallowed with water within 30 minutes after a meal.
Danish: Capecitabine Medac-tabletterne sluges hele med vand inden for 30 minutter efter et måltid.
English: Capecitabine is a ‘prodrug' that is converted to 5-fluorouracil (5-FU) in the body, but more is converted in tumour cells than in normal tissues.
Danish: Capecitabin er et ‘prodrug' (et forstadium), der i kroppen omdannes til 5fluoruracil (5-FU), men omdannelsen sker i højere grad i svulstcellerne end i normalt væv.
English: In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
Danish: I kroppen indtager 5-FU pyrimidinets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af nyt dna.
English: Because Capecitabine Medac contains the same active substance as its reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Capecitabine Medac indeholder det samme aktive stof som referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body).
Danish: • lokalt fremskredent eller metastatisk brystkræft (brystkræft, der er begyndt at brede sig til andre dele af kroppen).
English: For more information about treatment with Capecitabine 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 Capecitabine Medac, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It can also be used on its own when treatment with both anthracyclines and taxanes (another type of anticancer medicine) has failed or when repeat treatment with anthracyclines is not suitable for the patient.
Danish: Det kan også bruges alene, når behandling med såvel antracykliner som taxaner (en anden form for lægemiddel mod kræft) ikke har virket, eller når det ikke er hensigtsmæssigt for patienten at gentage behandlingen med antracykliner.
English: The company carried out a ‘bioequivalence' study to show that 500 mg Capecitabine Medac produces the same levels of capecitabine in the blood as 500 mg Xeloda.
Danish: Virksomheden foretog ”bioækvivalens”-undersøgelser for at påvise, at 500 mg Capecitabine Medac producer den samme mængde capecitabin i blodet som 500 mg Xeloda.
English: Full details are available in the summary of product characteristics (also part of the EPAR).
Danish: De fuldstændige oplysninger herom fremgår af produktresuméet (også en del af denne EPAR).
English: The CHMP concluded that, in accordance with EU requirements, Capecitabine Medac has been shown to have comparable quality and to be bioequivalent to Xeloda.
Danish: CHMP konkluderede, at Capecitabine Medac i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Xeloda.
English: Capecitabine Medac capecitabine
Danish: Capecitabine Medac capecitabin
English: Therefore, the CHMP's view was that, as for Xeloda, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Xeloda.
English: Doses need to be adjusted for patients with liver or kidney disease and for patients who develop certain side effects.
Danish: Dosis skal tilpasses, hvis patienten har lever- eller nyresygdom, eller hvis der opstår bestemte bivirkninger.
English: The doctor will calculate the number of 150, 300 and 500 mg tablets the patient needs to take.
Danish: Lægen beregner det antal tabletter på 150 mg, 300 mg og 500 mg, som patienten skal tage.
English: While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets.
Danish: Mens referencelægemidlet Xeloda fås som 150 og 500 mg-tabletter, så fås Capecitabine Medac også som 300 mg-tabletter.
English: The company provided data from the published literature on capecitabine.
Danish: Virksomheden fremlagde data om capecitabin fra den offentliggjorte faglitteratur.
English: • colon (large bowel) cancer.
Danish: • tyktarmskræft (koloncancer).
English: Capecitabine Medac is a ‘generic' and a ‘hybrid' medicine.
Danish: Capecitabine Medac er et “generisk” og ”hybridt” lægemiddel.
English: Capecitabine Medac is used with or without other anticancer medicines;
Danish: Capecitabine Medac anvendes med eller uden andre lægemidler mod kræft,
English: • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
Danish: • metastatisk kolorektal cancer (kræft i tyktarm/endetarm, der har bredt sig til andre dele af kroppen).
English: The Committee recommended that Capecitabine Medac be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Capecitabine Medac.
English: What are the benefits and risks of Capecitabine Medac?
Danish: Hvilke fordele og risici er der forbundet med Capecitabine Medac?
English: • advanced gastric (stomach) cancer.
Danish: • fremskreden mavekræft.
English: The active substance in Capecitabine Medac, 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 Medac, capecitabin, er et cytotoksisk lægemiddel (et lægemiddel, som dræber celler, der deler sig såsom kræftceller) og tilhører gruppen af 'antimetabolitter' (stofskiftehæmmere).
English: Capecitabine Medac 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 Medac kan anvendes med eller uden andre midler mod kræft til patienter, der er opereret for tyktarmskræft i ”stadium III” eller ”Dukes' stadium C”,
English: Capecitabine Medac is used with other anticancer medicines, including a platinum-containing anticancer medicine such as cisplatin;
Danish: Capecitabine Medac anvendes sammen med andre lægemidler mod kræft, herunder et platinholdigt kræftmiddel såsom cisplatin,
English: Capecitabine Medac should only be prescribed by a doctor who is qualified in the use of anticancer medicines.
Danish: Capecitabine Medac må kun ordineres af en læge, som er specialiseret inden for lægemidler mod kræft.
English: Capecitabine Medac is a medicine that contains the active substance capecitabine.
Danish: Capecitabine Medac er et lægemiddel, der indeholder det aktive stof capecitabin.
English: Other information about Capecitabine Medac
Danish: Andre oplysninger om Capecitabine Medac:
English: Capecitabine Medac is used with docetaxel (another anticancer medicine) after treatment with anthracyclines (another type of anticancer medicine) has failed.
Danish: Capecitabine Medac 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 Medac is an anticancer medicine.
Danish: Capecitabine Medac er et lægemiddel mod kræft.
English: Why has Capecitabine Medac been approved?
Danish: Hvorfor blev Capecitabine Medac godkendt?
English: How has Capecitabine Medac been studied?
Danish: Hvordan blev Capecitabine Medac undersøgt?
English: What is Capecitabine Medac?
Danish: Hvad er Capecitabine Medac?
English: What is Capecitabine Medac used for?
Danish: Hvad anvendes Capecitabine Medac til?
English: How is Capecitabine Medac used?
Danish: Hvordan anvendes Capecitabine Medac?
English: How does Capecitabine Medac work?
Danish: Hvordan virker Capecitabine Medac?
English: You may need to read it again.
Danish: De får muligvis behov for at læse den igen.
English: Contains E110.
Danish: Indeholder E110.
English: Do not pass it on to others.
Danish: Lad derfor være med at give det til andre.
English: This is to ensure that you receive sufficient treatment.
Danish: Det er for at sikre, at De får en tilstrækkelig behandling.
English: 3 years.
Danish: 3 år
English: The bottle also contains a cotton filler.
Danish: Flasken indeholder også et bomuldsfyld.
English: Oral use.
Danish: Oral anvendelse.
English: These side effects may occur with certain frequencies, which are defined as follows: • very common:
Danish: Bivirkninger kan forekomme med en given hyppighed, som defineres på følgende måde: • Meget almindelig:
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Please consult your doctor if you plan to become pregnant.
Danish: Spørg Deres læge til råds, hvis De planlægger at blive gravid.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: DATE OF REVISION OF THE TEXT
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: - This medicine has been prescribed for you personally.
Danish: - Lægen har ordineret dette lægemiddel til Dem personligt.
English: frequency cannot be estimated from the available data.
Danish: hyppigheden kan ikke bestemmes ud fra de kendte data.
English: Taking Wilzin with food and drink
Danish: Brug af Wilzin sammen med mad og drikke
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden De begynder at anvende dette lægemiddel.
English: 4.9 Overdose
Danish: 4.9 Overdosering
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: See the package leaflet for further information.
Danish: Se indlægsseddel for yderligere informationer.
English: However, protein appears to interfere the least.
Danish: Det synes dog som protein giver den mindste påvirkning.
English: There is no difference in dose between symptomatic and presymptomatic patients.
Danish: Der er ingen forskel på dosis hos symptomatiske og præsymptomatiske patienter.
English: System organ class
Danish: Systemorganklasse
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til websites om sjældne sygdomme, og hvordan de behandles.
English: Treatment of Wilson's disease.
Danish: Til behandling af Wilson´s sygdom.
English: MANUFACTURER'S BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER
English: If you become pregnant during therapy with Wilzin, your doctor will decide which treatment and which dose is best in your situation.
Danish: Hvis De bliver gravid under behandlingsforløbet med Wilzin, så vil Deres læge beslutte hvilken behandling og hvilken dosis, der er bedst i Deres situation.
English: • Risk Management Plan (RMP)
Danish: • Risikostyringsplan (RMP) Ikke relevant.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible.
Danish: Der findes kun begrænsede oplysninger om børn under 6 år, men da sygdommen er fuldt gennemgribende, skal forebyggende behandling overvejes så tidligt som muligt.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: Indehaveren af markedsføringstilladelsen skal oplyse Europa-Kommissionen om markedsføringsplanen for det lægemiddel, der er godkendt i henhold til denne beslutning.
English: • Pregnant women:
Danish: • Gravide kvinder:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har.
English: Date of first authorisation: 13 October 2004 Date of latest renewal: 13 October 2009
Danish: Dato for første markedsføringstilladelse: 13 oktober 2004 Dato for sidste fornyelse: 13 oktober 2009
English: If you forget to take Wilzin: Do not take a double dose to make up for a forgotten individual dose.
Danish: Hvis De har glemt at tage Wilzin: De må ikke tage en dobbeltdosis som erstatning for glemte enkeltdoser.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Therapeutic monitoring
Danish: Terapeutisk monitorering
English: The most common undesirable effect is gastric irritation.
Danish: Den mest almindelige bivirkning er gastrisk irritation.
English: This is usually worst with the first morning dose and disappears after the first days of treatment.
Danish: Det er normalt værst i forbindelse med den første morgendosis og forsvinder efter et par dages behandling.
English: Each bottle contains 250 capsules.
Danish: Hver beholder indeholder 250 kapsler.
English: Not applicable.
Danish: Ikke relevant.
English: INFORMATION ON BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT
English: A. LABELLING
Danish: A. ETIKETTERING
English: • After Wilzin intake, gastric irritation may occur, especially at the beginning of treatment.
Danish: • Efter indtagelse af Wilzin kan der forekomme maveirritatation, specielt i starten af behandlingen.
English: Some patients experience stomach upset after the morning dose.
Danish: Nogle patienter oplever ubehag i maven efter morgendosis.
English: It is very important to continue anti-copper therapy during pregnancy.
Danish: Det er meget vigtigt at fortsætte antikobber behandling undervejs i graviditeten.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: Anaemia may be micro-, normo- or macrocytic and is often associated with leukopenia.
Danish: Anæmi kan være mikro-, normo- eller makrocystisk og forbindes ofte med leukopeni.
English: Always take Wilzin exactly as your doctor has told you.
Danish: Brug altid Wilzin nøjagtigt efter lægens anvisning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Wilzin is a life-long therapy.
Danish: Wilzin er en livsvarig behandling.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Do not take Wilzin If you are allergic (hypersensitive) to zinc or any of the other ingredients of Wilzin.
Danish: Brug ikke Wilzin Hvis De er overfølsom (allergisk) over for zink eller et af de øvrige indholdsstoffer i Wilzin.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelige (≥1/10), almindelige (≥1/100 til<1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Uncommon: • A decrease in blood red and white cells may occur.
Danish: Usædvanlige bivirkninger: • Der kan forekomme et fald i blodets røde og hvide blodlegemer.
English: If you take more Wilzin than prescribed, you may experience nausea, vomiting and dizziness.
Danish: Hvis De tager mere Wilzin end der er ordineret, kan De opleve kvalme, opkast og svimmelhed.
English: FURTHER INFORMATION
Danish: Yderligere oplysninger
English: You should tell your doctor if you experience unusual muscle weakness or abnormal feeling in your limbs as this may indicate excessive treatment.
Danish: Du skal fortælle din læge, hvis du oplever en usædvanlig muskelsvaghed eller en unormal følelse i arme eller ben, da det kan være tegn på overbehandling.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Danish: De rapporterede bivirkninger er listet efter systemorganklasse og hyppighed nedenfor.
English: • Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.
Danish: • Der er rapporteret forandringer i blodprøveværdierne, herunder en øgning af visse lever- og bugspytkirtelenzymer.
English: A change of therapy is recommended in this situation.
Danish: I sådan en situation anbefales det at skifte behandling.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Read the package leaflet before use.
Danish: Læs indlægssedlen før brug.
English: This potentially leads to liver damage and neurological disorders.
Danish: Det kan potentielt betyde leverskader og neurologiske forstyrrelser.
English: Blood and lymphatic system disorders uncommon: sideroblastic anaemia, leukopenia
Danish: Sygdomme i blod og lymfesystemet usædvanlige: Sideroblastisk anæmi; leukopeni
English: • Children and adolescents:
Danish: • Børn og unge:
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: In all cases, dose should be adjusted according to therapeutic monitoring (see section 4.4.
Danish: I alle tilfælde skal dosis justeres i henhold til terapeutisk monitorering (se pkt.
English: SPECIAL STORAGE CONDITIONS
Danish: SÆRLIGE OPBEVARINGSBETINGELSER
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest godkendt