FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Pandemic Influenza Vaccine H5N1 Baxter AG produced an antibody response that met these criteria.
Danish: Undersøgelsen viste, at Pandemic Influenza Vaccine H5N1 Baxter AG udløste en antistofrespons, der opfyldte disse kriterier.
English: The CHMP decided that Pandemic Influenza Vaccine H5N1 Baxter AG's benefits are greater than its risks in all age groups investigated and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Pandemic Influenza Vaccine H5N1 Baxter AG var større end risiciene i alle de undersøgte grupper, og anbefalede udstedelse af en markedsføringstilladelse for Pandemic Influenza Vaccine H5N1 Baxter AG.
English: The viruses used in Pandemic Influenza Vaccine H5N1 Baxter AG are grown in mammal cells (‘vero cells'), unlike those in some other flu vaccines, which are grown in hen's eggs.
Danish: De vira, der anvendes i Pandemic Influenza Vaccine H5N1 Baxter AG, dyrkes i pattedyrceller (‘veroceller') i modsætning til andre influenzavacciner, der dyrkes i hønseæg.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine that is given by injection.
Danish: Pandemic Influenza Vaccine H5N1 Baxter AG er en vaccine, der gives ved injektion.
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a vaccine to prevent ‘pandemic' flu.
Danish: Pandemic Influenza Vaccine H5N1 Baxter AG er en vaccine til forebyggelse af ‘pandemisk' influenza.
English: For the full list of all side effects reported with Pandemic Influenza Vaccine H5N1 Baxter AG, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Pandemic Influenza Vaccine H5N1 Baxter AG fremgår af indlægssedlen.
English: What measures are being taken to ensure the safe and effective use of Pandemic Influenza Vaccine H5N1 Baxter AG?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pandemic Influenza Vaccine H5N1 Baxter AG?
English: Other information about Pandemic Influenza Vaccine H5N1 Baxter AG
Danish: Andre oplysninger om Pandemic Influenza Vaccine H5N1 Baxter AG
English: What information is still awaited for Pandemic Influenza Vaccine H5N1 Baxter AG?
Danish: Hvilke oplysninger afventes der stadig for Pandemic Influenza Vaccine H5N1 Baxter AG?
English: Baxter AG will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Danish: Under en pandemi skal virusstammen i Pandemic Influenza Vaccine H5N1 Baxter AG erstattes med den stamme, der forårsager pandemien, inden vaccinen kan bruges.
English: Why has Pandemic Influenza Vaccine H5N1 Baxter AG been approved?
Danish: Hvorfor blev Pandemic Influenza Vaccine H5N1 Baxter AG godkendt?
English: What is the risk associated with Pandemic Influenza Vaccine H5N1 Baxter AG?
Danish: Hvilken risiko er der forbundet med Pandemic Influenza Vaccine H5N1 Baxter AG?
English: Pandemic Influenza Vaccine H5N1 Baxter AG is a ‘mock-up' vaccine.
Danish: Pandemic Influenza Vaccine H5N1 Baxter AG er en ‘mockup'-vaccine.
English: How has Pandemic Influenza Vaccine H5N1 Baxter AG been studied?
Danish: Hvordan blev Pandemic Influenza Vaccine H5N1 Baxter AG undersøgt?
English: What is Pandemic Influenza Vaccine H5N1 Baxter AG?
Danish: Hvad er Pandemic Influenza Vaccine H5N1 Baxter AG?
English: What is Pandemic Influenza Vaccine H5N1 Baxter AG used for?
Danish: Hvad anvendes Pandemic Influenza Vaccine H5N1 Baxter AG til?
English: How is Pandemic Influenza Vaccine H5N1 Baxter AG used?
Danish: Hvordan anvendes Pandemic Influenza Vaccine H5N1 Baxter AG?
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Danish: Først når pandemien er brudt ud, ved man, hvilken influenzavirusstamme der forårsager den.
English: How does Pandemic Influenza Vaccine H5N1 Baxter AG work?
Danish: Hvordan virker Pandemic Influenza Vaccine H5N1 Baxter AG?
English: The metabolism in horses has not been investigated.
Danish: Metabolismen hos hest er ikke undersøgt.
English: DATE OF REVISION OF THE TEXT
Danish: Dato for ændring af teksten
English: Treatment of calves with Emdocam 20 minutes before dehorning reduces post-operative pain.
Danish: Behandling af kalve med Emdocam 20 minutter før afhorning reducerer postoperativ smerte.
English: Date of first authorisation: 18.08.2011 Date of last renewal: 21.06.2016
Danish: Dato for første markedsføringstilladelse: 18.08.2011 Dato for seneste fornyelse af markedsføringstilladelse: 21.06.2016
English: Emdocam alone will not provide adequate pain relief during the dehorning procedure.
Danish: Emdocam alene vil ikke give tilstrækkelig smertelindring under afhorning.
English: People with known hypersensitivity to Non-Steroidal AntiInflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for nonsteroide antiinflammatoriske lægemidler (NSAID-præparater) bør undgå kontakt med veterinærlægemidlet.
English: It reduces leukocyte infiltration into the inflamed tissue.
Danish: Det reducerer leukocytinfiltrationen i det betændte væv.
English: MANUFACTURER´S BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER
English: In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner som kan være alvorlige (herunder dødelige) forekomme.
English: Do not breach the vial more than 50 times.
Danish: Bryd ikke hætteglasset mere end 50 gange.
English: If required, a second administration of meloxicam can be given after 24 hours.
Danish: Om nødvendigt kan en yderligere dosis gives efter 24 timer.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Danish: Hjælpestofferne nævnt i afsnit 6.1 i produktresuméet er enten tilladte stoffer hvor ingen MRL-værdier er påkrævet, hvilket er indikeret i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 eller som benyttet i produktet ikke anses for at være omfattet af forordning (EF) nr. 470/2009.
English: Marketing authorisation holder Emdoka bvba
Danish: Indehaver af markedsføringstilladelsen Emdoka bvba
English: Do not broach the vial more than 50 times.
Danish: Bryd ikke hætteglasset mere end 50 gange
English: Ethanol (96%) 150 mg Clear yellow solution for injection.
Danish: Etanol (96 %) 150 mg Klar gul injektionsvæske, opløsning.
English: 15 μg/kg Milk
Danish: 15 µg/kg Mælk
English: The highest meloxicam concentrations are to be found in liver and kidney.
Danish: De højeste meloxicamkoncentrationer ses i lever og nyrer.
English: Meloxicam in Emdocam 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Meloxicam i Emdocam 20 mg/ml injektionsvæske, opløsning til kvæg, gris og heste er et tilladt stof beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
English: EXP {month/year}
Danish: EXP {MM/ÅÅÅÅ}
English: Ethanol
Danish: Etanol
English: Milk: 5 days
Danish: Mælk: 5 dage
English: Name and address of the manufacturer responsible for batch release Produlab Pharma bv
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Produlab Pharma bv
English: 20 μg/kg 65 μg/kg 65 μg/kg
Danish: 20 µg/kg 65 µg/kg 65 µg/kg
English: Each vial is closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
Danish: Hvert hætteglas er lukket med en bromobutylgummiprop og forseglet med en aluminiumshætte.
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan forekomme en forbigående hævelse på injektionsstedet, som forsvinder uden indgriben.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 28 days
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år Opbevaringstid efter første åbning af den indre emballage: 28 dage
English: Emdoka bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgium
Danish: Emdoka bvba J. Lijsenstraat 16 B-2321 Hoogstraten Belgien
English: Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Danish: Meloxicam elimineres med halveringstider på 26 og 17,5 time efter subkutan injektion hos henholdsvis ungkvæg og lakterende køer.
English: Any unused medicines should not be disposed of via wastewater or household waste.
Danish: Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Danish: Hvis der forekommer bivirkninger, bør behandlingen afbrydes, og dyrlægen kontaktes.
English: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
Danish: Til anvendelse ved akut respiratorisk infektion i kombination med passende antibiotikabehandling med henblik på at reducere kliniske symptomer hos kvæg.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og hætteglasset efter EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY"
Danish: TEKSTEN ”TIL DYR”
English: For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.
Danish: Til supplerende behandling af puerperal sepsis og toksikæmi (mastitis-metritis-agalaktisk syndrom) med passende antibiotikabehandling.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: EXP {month/year} Once broached, use by…
Danish: EXP.{MM/ÅÅÅÅ} Efter åbning anvendes inden…
English: Horses: I.V.
Danish: Heste: i.v.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals, including isolated reports treated).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) -.
English: For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Danish: Til supplerende behandling af akut mastitis i kombination med antibiotikabehandling.
English: Pack size of 1 colourless Type I glass vial containing 50 ml, 100 ml or 250 ml.
Danish: Pakningsstørrelse med 1 farveløst Type I hætteglas hver indeholdende 50 ml, 100 ml eller 250 ml.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: To obtain adequate pain relief during surgery, co-medication with an appropriate analgesic is needed.
Danish: For at opnå tilstrækkelig smertelindring under kirurgi er yderligere medicinering med passende analgetikum nødvendig.
English: Shelf-life after first opening of the container: 28 days.
Danish: Holdbarhed efter første åbning af beholderen: 28 dage.
English: SC Altius SRL Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti - RO Tel: + 40 021 310 88 80
Danish: Str Iancu Capitanu nr 38 Ap 1 Sector 2, Bucuresti - RO Tel: + 40 021 310 88 80
English: ChemVet dk A/S A.C. Illums Vej 6
Danish: ChemVet dk A/S A.C.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg opnåedes Cmax værdier på 2,1 µg/ml efter 7,7 timer og 2,7 µg/ml efter 4 timer hos henholdsvis ungkvæg og lakterende køer.
English: For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.
Danish: Ved lindring af betændelse og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet kan behandlingen fortsættes med en passende oral behandling indeholdende meloxicam, administreret i overensstemmelse med anbefalingerne på etiketten.
English: H-7020 Dunaföldvár Tel.: +36 75 542 940
Danish: HU-7020 Dunaföldvár Tel.: +36 75 542 940
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Danish: Efter to intramuskulære doser på 0,4 mg meloxicam/kg opnåedes efter 1 time en Cmax værdi på 1,9 µg/ml hos grise.
English: Cattle: meat and offal: 15 days; milk: 5 days
Danish: kød og indmad: 15 dage; mælk: 5 dage
English: Once broached, use by…
Danish: Efter åbning anvendes inden …
English: Cattle: S.C., I.V.
Danish: s.c., i.v.
English: Meloxicam Meloxicam Bovine, caprine, porcine, rabbit,
Danish: Meloxicam Meloxicam Kreaturer, geder, grise kanin, dyr tilhørende hestefamilien
English: A slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
Danish: Hos mindre end 10 % af behandlet kvæg i kliniske studier sås let og forbigående hævelse på injektionsstedet efter subkutan injektion.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label for 50 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: Emdocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Danish: Emdocam 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste meloxicam
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant medicinal products.
Danish: Må ikke gives samtidig med glukokortikosteroider, anden non-steroid antiinflammatorisk behandling eller sammen med antikoagulantia.
English: Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
Danish: Emdocam 20 mg/ml Injektionsvæske, opløsning til kvæg, grise og heste
English: Bovine, caprine
Danish: Kreaturer, geder
English: Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Danish: Enkelt intravenøs injektion på 0,6 mg meloxicam/kg legemsvægt (d.v.s. 3 ml/100 kg legemsvægt).
English: WITHDRAWAL PERIODS
Danish: TILBAGEHOLDELSESTIDER
English: Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan eller intravenøs injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 2,5 ml/100 kg legemsvægt), om nødvendigt i kombination med antibiotikabehandling eller med oral tilførsel af passende mængder vand.
English: 150 mg For the full list of excipients, see section 6.1.
Danish: 150 mg Alle hjælpestoffer er anført under pkt.
English: Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Danish: Enkelt intramuskulær injektion på 0,4 mg meloxicam/kg legemsvægt (d.v.s. 2 ml/100 kg legemsvægt) i kombination med passende antibiotikabehandling.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose, symptomatic treatment should be initiated.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift):
English: 4.9 Amounts to be administered and administration route
Danish: 4.9 Dosering og indgivelsesvej Kvæg
English: No entry Anti-inflammatory agents/Non-steroidal anti-inflammatory agents
Danish: Ej udfyldt Antiinflammatoriske og antireumatiske lægemidler, nonsteroider
English: Do not use in pregnant and lactating mares.
Danish: Må ikke anvendes til drægtige eller lakterende hopper.
English: Ethanol (96%) Poloxamer 188
Danish: - Etanol (96 %) - Poloxamer 188 - Macrogol 300 - Glycin - Natriumhydroxid - Saltsyre - Meglumin - Vand til injektionsvæsker
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Kvæg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON - 50, 100 or 250 ml vials
Danish: YDRE KARTON - 50, 100 eller 250 ml hætteglas
English: NL-4941 SJ Raamsdonksveer The Netherlands
Danish: Fremstiller ansvarlig for batchfrigivelse: Produlab Pharma bv NL-4941 SJ Raamsdonksveer Nederlandene
English: Withdrawal periods: Cattle: meat and offal: 15 days; milk: 5 days.
Danish: Kvæg: kød og indmad: 15 dage; mælk: 5 dage Grise: kød og indmad: 5 dage Heste: kød og indmad: 5 dage Må ikke anvendes til heste, hvis mælk er bestemt til menneskeføde.
English: MRL Target tissues
Danish: SC Altius SRL
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS , IF ANY
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: Not authorised for use in horses producing milk for human consumption.
Danish: kød og indmad: 5 dage Må ikke anvendes til heste, hvis mælk er bestemt til menneskeføde.
English: Emdocam 20 mg/ml solution for injection for cattle, pigs and horses NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: 4.11 Withdrawal periods
Danish: 10. TILBAGEHOLDELSESTIDER
English: ROUTE(S) OF ADMINISTRATION Cattle: SC ,IV
Danish: INDGIVELSESVEJ(E) Kvæg:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cattle: SC, IV
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kvæg:
English: Once broached, use by _____
Danish: Efter anbrud anvendes inden
English: DD.MM.YYYY
Danish: DD.MM.ÅÅÅÅ
English: Horses: meat and offal: 5 days
Danish: kød og indmad: 5 dage
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label for 100 ml and 250 ml
Danish: Hætteglasetiket for 100 ml og 250 ml
English: meat and offal: 5 days.
Danish: Kød og indmad: 15 dage,
English: The European Commission granted a marketing authorisation valid throughout the European Union for DepoCyte on 11 July 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for DepoCyte den 11. juli 2001.
English: DepoCyte cytarabine
Danish: DepoCyte cytarabin
English: This document is a summary of the European Public Assessment Report (EPAR) for DepoCyte.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for DepoCyte.
English: The marketing authorisation holder is Pacira Limited.
Danish: Indehaveren af markedsføringstilladelsen er Pacira Limited.
English: Other information about DepoCyte:
Danish: Andre oplysninger om DepoCyte:
English: The main measure of effectiveness was the number of patients who responded to treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på antallet af patienter, som reagerede på behandlingen.
English: A patient was classified as a ‘responder' if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks.
Danish: Patienter blev klassificeret som ”reagerende”, hvis de ikke havde nogen kræftceller i rygmarvsvæsken efter endt behandling, og hvis deres symptomer ikke var blevet forværret efter fire uger.
English: It must not be used in patients who have an active infection in the meninges.
Danish: Det må ikke gives til patienter, som har aktiv betændelse af meninges.
English: In the main study, 72% of the patients who received DepoCyte responded to treatment (13 out of 18), compared with 18% of those who received the standard formulation of cytarabine (3 out of 17).
Danish: I hovedundersøgelsen reagerede 72 % af de patienter, der modtog DepoCyte (13 ud af 18), på behandlingen, sammenlignet med 18 % af de patienter, der modtog standardformuleringen af cytarabin (3 ud af 17).
English: The full EPAR for DepoCyte can be found here.
Danish: Den fuldstændige EPAR for DepoCyte findes her.
English: DepoCyte should only be given by a doctor who has experience in the use of anticancer medicines.
Danish: Behandling med DepoCyte må kun iværksættes af en læge med erfaring i brug af lægemidler mod cancer.
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 DepoCyte.
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 DepoCyte.
English: For more information about treatment with DepoCyte, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med DepoCyte, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: However, there was no difference between the two medicines in how long the patients lived without their nerve disease getting worse.
Danish: Der var dog ingen forskel på de to lægemidler med hensyn til, hvor lang tid patienterne levede uden en forværring af deres nervesygdom.
English: The active substance in DepoCyte, cytarabine (also known as ara-C), is an anticancer medicine that has been used since the 1970s.
Danish: Det aktive stof i DepoCyte, cytarabin (også kaldet ara-C), er et middel mod kræft, som har været anvendt siden 1970'erne.
English: DepoCyte helps to control the symptoms of the disease.
Danish: DepoCyte medvirker til at holde symptomerne på sygdommen under kontrol.
English: Cytarabine is an analogue of pyrimidine.
Danish: Cytarabin er en analog af pyrimidin.
English: The Committee decided that DepoCyte's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved DepoCyte opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The study also looked at how long the patients lived without their nerve disease getting worse.
Danish: I undersøgelsen så man endvidere på, hvor lang tid patienterne levede uden en forværring af deres nervesygdom.
English: DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of the other ingredients.
Danish: DepoCyte må ikke gives til patienter, der kan være overfølsomme (allergiske) over for cytarabin eller andre af indholdsstofferne.
English: DepoCyte is used to treat lymphomatous meningitis.
Danish: DepoCyte anvendes til behandling af lymfomatøs meningitis.