FrancophonIA/ELRC3.0 huggingface dataset:
English: After first opening: from a microbiological point of view, the product should be used immediately.
Danish: Efter åbning første gang: Fra et mikrobiologisk synspunkt bør produktet anvendes omgående.
English: Date of first authorisation: 11 July 2001 Date of latest renewal: 11 July 2011
Danish: Dato for første markedsføringstilladelse: 11. juli 2001 Dato for seneste fornyelse: 11. juli 2011
English: Your doctor will check for these symptoms regularly.
Danish: Din læge vil kontrollere dig regelmæssigt for disse symptomer.
English: Safety and efficacy in children aged under 18 years have not been established.
Danish: Sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: The recommended dose will be given to you by the doctor or physician as necessary.
Danish: Den anbefalede dosis vil blive givet til dig af lægen efter behov.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: In the majority of patients such treatment will be part of symptomatic palliation of the disease.
Danish: Hos flertallet af patienter vil en sådan behandling være en del af en symptomatisk lindring af sygdommen.
English: Toxic effects may be related to a single dose or to cumulative doses.
Danish: Toksiske virkninger kan være relateret til en enkelt dosis eller til kumulative doser.
English: Side effects may occur after each injection, usually within the first five days.
Danish: Bivirkninger kan forekomme efter hver injektion, som regel i løbet af de første fem dage.
English: • a designated area should be defined for preparation (preferably under a laminar flow system).
Danish: • Der bør defineres et specielt område til præparationen (fortrinsvis under et system med laminar air flow).
English: Therefore monitoring of the haemopoietic system is advised.
Danish: Derfor anbefales monitorering af det hæmopoietiske system.
English: Because these reactions are reported from a population of uncertain size, it is not possible to reliably estimate their frequency.
Danish: Da disse reaktioner er blevet rapporteret fra en population af ukendt størrelse, er det ikke muligt at vurdere deres hyppighed.
English: • personnel should be trained in good technique for handling anticancer agents;
Danish: • Personalet bør undervises i god teknik til håndtering af anticancer midler;
English: Patients who did not respond discontinued protocol treatment after 4 weeks.
Danish: De patienter, som ikke responderede, afbrød protokolbehandlingen efter 4 uger.
English: • Infection of the meninges
Danish: • Infektion af meninges
English: Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper handling technique, use of a suitable designated area, protective clothing, procedures to address risk of contamination).
Danish: Der skal tages korrekte forholdsregler ved håndtering og administration af et cytotoksisk lægemiddel (korrekt håndteringsteknik, anvendelse af særligt egnet område, beskyttelsesbeklædning, procedurer hvor risiko for kontaminering undgås).
English: More than 90% of cytarabine was excreted by day 4 and an additional 2.7% by 21 days.
Danish: Mere end 90 % cytarabin var udskilt på dag 4 og yderligere 2,7 % efter 21 dage.
English: Do not operate any tools or machines during treatment.
Danish: Lad være med at arbejde med værktøj eller maskiner under behandlingen.
English: DepoCyte should not be diluted or mixed with any other medicinal products, as any change in concentration or pH may affect the stability of the microparticles.
Danish: DepoCyte bør ikke fortyndes eller blandes med andre lægemidler, da enhver ændring i koncentration eller pH kan påvirke stabiliteten af mikropartiklerne.
English: Teratology studies in animals have not been conducted with DepoCyte and there are no adequate and well controlled studies in pregnant women.
Danish: Der er ikke udført teratogene studier på dyr med DepoCyte og der findes hverken tilstrækkelige eller velkontrollerede studier af gravide kvinder.
English: If neurotoxicity develops, the dose should be reduced to 25 mg.
Danish: Hvis der opstår neurotoksicitet, bør dosis reduceres til 25 mg.
English: DepoCyte is not recommended for use in children and adolescents until further data become available.
Danish: DepoCyte frarådes hos børn og unge, indtil der foreligger yderligere oplysninger.
English: No further reconstitution or dilution is required.
Danish: Ingen yderligere rekonstitution eller fortynding er nødvendig.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT
English: Tell the medical staff monitoring you during this time, if you suffer from:
Danish: Oplys sundhedspersonalet, der kontrollerer dig i løbet af denne periode, hvis du får:
English: It should not be shaken vigorously.
Danish: Det må ikke rystes kraftigt.
English: No statistically significant differences were noted in secondary endpoints such as duration of response, progression-free survival, neurological signs and symptoms, Karnofsky performance status, quality of life and overall survival.
Danish: Der blev ikke registreret statistisk signifikante forskelle i sekundære endepunkter såsom varighed af respons, progressionsfri overlevelse, neurologiske tegn og symptomer, Karnofsky performance status, livskvalitet og samlet overlevelse.
English: This patient, however, was also receiving concomitant whole brain irradiation and had previously received intraventricular methotrexate.
Danish: Denne patient fik imidlertid samtidig strålebehandling af hele hjernen og havde tidligere fået intraventrikulær methotrexat.
English: These reactions have been reported mainly from post-marketing experience with DepoCyte as spontaneous case reports.
Danish: Disse reaktioner er hovedsageligt blevet rapporteret efter markedsføringen af DepoCyte som spontane tilfælderapporter.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE /FORNYELSE AF TILLADELSEN
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 kan også indberette bivirkninger direkte til Sundhedsstyrelsen 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: • Blindness and other visual disturbances
Danish: • Blindhed og andre synsforstyrrelser
English: DepoCyte must be used as supplied; it must not be diluted (see section 6.2).
Danish: DepoCyte skal anvendes som leveret; må ikke fortyndes (se afsnit 6.2).
English: • male and female staff who are trying to conceive and female staff who are pregnant should be excluded from working with the substance;
Danish: • Kvindelige og mandlige medarbejdere, som prøver at få børn og kvindelige medarbejdere, som er gravide, bør undtages fra arbejde med substansen;
English: Staff who are pregnant or trying to conceive (male and female) should not work with DepoCyte.
Danish: Personale, som er gravid eller forsøger at få børn (mænd og kvinder), bør ikke arbejde med DepoCyte.
English: The suspension must not be diluted.
Danish: Suspensionen må ikke fortyndes.
English: Management of overdose should be directed at maintaining vital functions.
Danish: Behandling af overdosering bør rettes mod opretholdelse af vitale funktioner.
English: EU/1/01/187/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/01/187/001
English: See section 4..
Danish: Se punkt 4.
English: Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.
Danish: Hydrocefalus er også rapporteret, muligvis fremskyndet af araknoiditis.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: DepoCyte must be used as supplied without further dilution.
Danish: DepoCyte skal anvendes som leveret uden yderligere fortynding.
English: In addition, compared with free cytarabine, the formulation increases the biological half-life by a factor of 27 to 71 depending upon the route of administration and the compartment sampled.
Danish: Desuden øger formuleringen, sammenlignet med frit cytarabin, den biologiske halveringstid med en faktor 27 til 71 afhængig af administrationsvej og den undersøgte kompartment.
English: Very common (experienced in more than 1 in 10 patients)
Danish: Meget almindelig (rammer mere end 1 ud af 10 patienter)
English: Incorporation into DNA and RNA may also contribute to cytarabine cytotoxicity.
Danish: Inkorporering i DNA og RNA kan også bidrage til cytarabins cytotoksicitet.
English: Because toxic effects can occur at any time during therapy (although they are most likely within 5 days of administration), patients receiving DepoCyte therapy should be monitored continuously for the development of neurotoxicity.
Danish: Da toksiske virkninger kan forekomme når som helst under behandlingen (selv om det er mest sandsynligt, at de forekommer i løbet af 5 dage efter indgiften), skal patienter, der får DepoCyte-behandling, konstant holdes under opsyn for udvikling af neurotoksicitet.
English: • personnel must wear protective clothing: goggles, gowns, disposable gloves and masks;
Danish: • Personale bør bære beskyttelsesudstyr: Beskyttelsesbriller, kittel, engangshandsker og maske;
English: There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
Danish: Der foreligger ingen rapporter, der eksplicit omhandler virkninger af DepoCyte-behandling på evnen til at køre motorkøretøj eller betjene maskiner.
English: Severe neurological side effects have been reported with the use of DepoCyte.
Danish: Der er rapporteret alvorlige neurologiske bivirkninger ved anvendelse af DepoCyte.
English: These changes were believed to be consistent with the toxic effects of other intrathecal agents such as unencapsulated cytarabine.
Danish: Disse forandringer blev betragtet som værende i overensstemmelse med de toksiske virkninger af andre intratekale stoffer såsom uindkapslet cytarabin.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 18 to 22°C.
Danish: Hvis det ikke anvendes omgående, er opbevaringstiden og -betingelserne under brug brugerens ansvar og bør normalt ikke være over 4 timer ved 18-22 °C.
English: • Persistent or extreme sleepiness
Danish: • Vedvarende eller ekstrem søvnighed
English: The work surface should be protected by disposable, plastic backed, absorbent paper;
Danish: Arbejdsfladen bør beskyttes med plastikforet, vandabsorberende engangspapir;
English: Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på æsken og hætteglasset.
English: The proportion of patients alive at 12 months was 24% for DepoCyte versus 19% for unencapsulated cytarabine.
Danish: Andelen af patienter i live efter 12 måneder var 24 % for DepoCyte versus 19 % for uindkapslet cytarabin.
English: Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
Danish: Almindelig (rammer mindre end 1 ud af 10, men mere end 1 ud af 100 patienter)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: For the treatment of lymphomatous meningitis, DepoCyte is given according to the following schedules:
Danish: Til behandling af lymfomatøs meningitis gives DepoCyte i henhold til følgende behandlingsplaner:
English: DepoCyte should be injected slowly over a period of 1-5 minutes.
Danish: DepoCyte skal injiceres langsomt i løbet af 1 - 5 minutter.
English: Each pack contains a single vial.
Danish: Hver pakke indeholder et enkelt hætteglas.
English: DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Danish: DepoCyte bør kun indgives under overvågning af en læge, som har erfaring med anvendelse af cancer kemoterapeutika.
English: DepoCyte administration
Danish: Administration af DepoCyte
English: Patients who achieved a response (defined as clearing of the CSF of malignant cells in the absence of progression of neurological symptoms) went on to receive Consolidation and Maintenance therapy for up to 29 weeks.
Danish: De patienter, som opnåede respons (defineret som svind af maligne celler fra spinalvæsken i fravær af progression af neurologiske symtomer), fortsatte med at få konsoliderings- og vedligeholdelsesbehandling i op til 29 uger.
English: Cytarabine, the active ingredient in DepoCyte, can cause foetal harm when administered systemically during pregnancy, mainly during the first trimester.
Danish: Cytarabin, der er det aktive stof i DepoCyte, kan forårsage fosterskader, når det indgives systemisk under graviditet, hovedsageligt i første trimester.
English: If patients develop neurotoxicity, subsequent doses of DepoCyte should be reduced, and treatment should be discontinued if toxicity persists.
Danish: Hvis patienter udvikler neurotoksicitet, skal efterfølgende doser af DepoCyte reduceres, og behandlingen skal standes, hvis toksicitet vedvarer.
English: Women should not breast-feed during treatment as DepoCyte may enter breast milk.
Danish: Kvinder bør ikke amme under behandlingen, da DepoCyte kan gå over i modermælken.
English: DepoCyte should be used as soon as possible after first opening, and should normally be used within 4 hours (stored at 18-22ºC).
Danish: DepoCyte skal anvendes så snart som muligt efter at være blevet åbnet første gang og skal normalt anvendes i løbet af 4 timer (opbevares ved 18 - 22 ºC).
English: The majority of DepoCyte patients went on beyond Induction to receive additional therapy.
Danish: Hovedparten af DepoCyte patienterne fortsatte udover induktionen og fik yderligere behandling.
English: The mechanism of action is not completely understood, but it appears that araCTP acts primarily through inhibition of DNA synthesis.
Danish: Virkningsmekanismen er ikke fuldt forstået, men det tyder på, at ara-CTP primært virker ved hæmning af DNA syntese.
English: The following protective recommendations are given due to the toxic nature of this substance:
Danish: Følgende forsigtighedsregler er opstillet p.g.a. stoffets toksicitet:
English: Mouse, rat and dog studies have shown that free cytarabine is highly toxic for the haemopoietic system.
Danish: Studier på mus, rotter og hunde har vist, at frit cytarabin er yderst toksisk for det hæmopoietiske system.
English: In-line filters must not be used when administering DepoCyte.
Danish: Der må ikke anvendes in-line filtre ved administration af DepoCyte.
English: Patients should be informed about the expected adverse reactions of headache, nausea, vomiting and fever, and about the early signs and symptoms of neurotoxicity.
Danish: Patienterne bør informeres om de forventede bivirkninger: Hovedpine, kvalme, opkastning og feber, og om de tidlige tegn og symptomer på neurotoksicitet.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 - 8 °C).
English: Median progression-free survival (defined as time to neurological progression or death) for all treated patients was 77 versus 48 days for DepoCyte versus unencapsulated cytarabine, respectively.
Danish: Median progressionsfri overlevelse (defineret som tid til neurologisk progression eller død) var for alle behandlede patienter henholdsvis 77 versus 48 dage for DepoCyte versus uindkapslet cytarabin.
English: You will also be given dexamethasone, usually as tablets but possibly by intravenous injection for 5 days after you receive each DepoCyte dose to help reduce any side effects which might occur.
Danish: Du vil også få dexamethason, sædvanligvis som tabletter, men muligvis som indsprøjtning gennem blodårerne i 5 dage efter hver DepoCyte dosis, for at medvirke til at mindske de bivirkninger, som måtte opstå.
English: Each vial contains 5 ml of suspension for a single injection.
Danish: Hvert hætteglas indeholder 5 ml suspension til en enkelt injektion.
English: However, on the basis of reported adverse reactions, patients should be advised against driving or using machines during treatment.
Danish: På baggrund af rapportede bivirkninger bør patienterne dog frarådes at køre motorkøretøj og betjene maskiner under behandlingen.
English: Similar changes (generally described as minimal to slight) were also observed in some animals receiving DepoFoam alone (DepoCyte vesicles without cytarabine) but not in sodium chloride solution control animals.
Danish: Lignende forandringer (almindeligvis beskrevet som minimale til lette) blev også observeret hos nogle dyr, der fik DepoFoam alene (DepoCyte vesikler uden cytarabin), men ikke hos kontroldyr, der fik natriumkloridopløsning.
English: PC: {number} SN: {number} NN: {number}
Danish: SN: {nummer} [serienummer]
English: Table 3 below lists these reactions for patients treated DepoCyte, and for patients treated with methotrexate and cytarabine as well.
Danish: Tabel 3 nedenfor viser disse bivirkninger for patienter behandlet med DepoCyte, og også for patienter behandlet med methotrexat og cytarabin.
English: Arachnoiditis, a very common adverse reaction associated with DepoCyte, is a syndrome manifested by several adverse reactions.
Danish: Araknoiditis, en meget almindelig bivirkning forbundet med DepoCyte, er et syndrom, der ytrer sig ved flere bivirkninger.
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/antikonception hos mænd og kvinder
English: Patients should be observed by the physician for immediate toxic reactions.
Danish: Patienterne bør holdes under observation af lægen for akutte toksiske reaktioner.
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Danish: Cytarabin forårsager omdannelse af hamster embryoceller og rotte H43 celler in vitro.
English: Injections are given slowly over 1-5 minutes and you may be asked to lie flat for one hour afterwards.
Danish: Indsprøjtningerne gives langsomt i løbet af 1-5 minutter, og du vil måske blive bedt om at ligge fladt ned den efterfølgende time.
English: • Nausea and/or vomiting
Danish: • Kvalme og/eller opkastning
English: Pharmacotherapeutic group: Antimetabolites, pyrimidine analogues, ATC code: L01BC01
Danish: Farmakoterapeutisk klassifikation: Antimetaboliter, pyrimidin-analoger, ATC kode L01BC01
English: A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids to those in DepoCyte indicates that such lipids are well tolerated in various animal species even when administered for prolonged periods at doses in the g/kg range.
Danish: En gennemgang af tilgængelige toksikologiske data for lipidbestanddelene (DOPC og DPPG) eller fosfolipider svarende til dem, der er i DepoCyte, tyder på, at sådanne lipider tolereres godt af forskellige dyrearter selv ved administration i længere perioder ved doser i g/kg området.
English: In vitro studies, examining more than 60 cell lines, demonstrated that the median cytarabine concentration resulting in 50% growth inhibition (IC50) was approximately 10 µM (2.4 µg/ml) for two days of exposure and 0.1 µM (0.024 µg/ml) for 6 days of exposure.
Danish: I in vitro studier, hvor mere end 60 cellelinier blev undersøgt, påviste, at mediancytarabinkoncentrationen, som resulterede i 50 % væksthæmning (IC50), var ca. 10 µM (2,4 µg/ml) ved 2 dages påvirkning og 0,1 µM (0,024 µg/ml) ved 6 dages påvirkning.
English: See ‘Precautions for the handling and disposal of DepoCyte' below.
Danish: Vi henviser til afsnit ”Forholdsregler ved håndtering og bortskaffelse af DepoCyte” nedenfor.
English: • Partial paralysis
Danish: • Delvis lammelse
English: Patients should be instructed to seek medical attention if signs or symptoms of neurotoxicity develop, or if oral dexamethasone is not well tolerated.
Danish: Patienterne bør instrueres i at søge lægehjælp, hvis der opstår tegn eller symptomer på neurotoksicitet eller hvis peroral dexamethason ikke tåles så godt.
English: The results of acute and subacute toxicity studies performed in monkeys suggested that intrathecal DepoCyte was tolerated up to a dose of 10 mg (comparable to a human dose of 100 mg).
Danish: Resultaterne af akutte og subakutte toksicitetsstudier på aber tyder på, at intratekalt DepoCyte blev tolereret i dosering på op til 10 mg (sammenligneligt med human dosering på 100 mg).
English: Precautions for the handling and disposal of DepoCyte
Danish: Forholdsregler ved håndtering og bortskaffelse af DepoCyte
English: There is no antidote for intrathecal DepoCyte or unencapsulated cytarabine released from DepoCyte.
Danish: Der findes ingen antidot mod intratekalt DepoCyte eller uindkapslet cytarabin frigivet fra DepoCyte.
English: The results suggest that the lipid components undergo hydrolysis and are largely incorporated in the tissues following breakdown in the intrathecal space.
Danish: Resultaterne tyder på, at lipidkomponenterne undergår hydrolyse og for størstedelen inkorporeres i vævene efter nedbrydning i det intratekale rum.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Slight to moderate inflammation of the meninges in the spinal cord and brain and/or astrocytic activation were observed in animals receiving intrathecal DepoCyte.
Danish: Let til moderat inflammation af meninges i rygmarv og hjerne og/eller astrocytaktivering blev observeret hos dyr, der fik intratekalt DepoCyte.
English: DepoCyte must not be mixed with any other medicinal products.
Danish: DepoCyte må ikke blandes med andre lægemidler.
English: • all items used during administration or cleaning should be placed in high risk, waste-disposal bags for high temperature incineration;
Danish: • Alle artikler, som anvendes ved indgift eller rengøring, bør anbringes i højrisiko affaldsposer til
English: • A stiff or rigid neck
Danish: • Stiv eller usmidig hals
English: Arachnoiditis is a syndrome manifested primarily by nausea, vomiting, headache and fever.
Danish: Araknoiditis er et syndrom, der viser sig primært ved kvalme, opkastning, hovedpine og feber.
English: If it persists, treatment with DepoCyte should be discontinued.
Danish: Hvis det vedvarer, skal DepoCytebehandlingen afbrydes.
English: Responses were observed in 13/18 (72%, 95% confidence intervals: 47, 90) of DepoCyte patients versus 3/17 (18% patients, 95% confidence intervals: 4, 43) in the unencapsulated cytarabine arm. A statistically significant association between treatment and response was observed (Fisher's exact test p-value = 0.002).
Danish: Respons blev observeret hos 13/18 (72 %, 95 % sikkerhedsintervaller: 47, 90) af DepoCyte patienterne versus 3/17 (18 % patienter, 95 % sikkerhedsintervaller: 4, 43) i den uindkapslede arm. En statistisk signifikant sammenhæng mellem behandling og respons blev observeret (Fisher's eksakte test pværdi= 0,002).
English: There is no antidote for DepoCyte.
Danish: Der findes ingen modgift mod DepoCyte.