FrancophonIA/ELRC3.0 huggingface dataset:
English: Lymphomatous meningitis is a condition in which tumour cells have invaded the fluid or membranes that surround the brain and spinal cord.
Danish: Lymfomatøs meningitis er en tilstand, hvor svulstceller har invaderet væsken eller membranerne, der omgiver hjernen og rygmarven.
English: Given that cytarabine has a mutagenic potential which could induce chromosomal damage in the human spermatozoa, males undergoing DepoCyte treatment and their partner should be advised to use a reliable contraceptive method.
Danish: Da cytarabin har et mutagent potentiale og muligvis kan inducere kromosomskader i humane spermatozoer, skal mænd i DepoCyte-behandling og deres partnere rådes til at anvende en pålidelig antikonceptionsmetode.
English: Infectious meningitis may be associated with intrathecal administration.
Danish: Infektiøs meningitis kan være forbundet med intratekal indgift.
English: DepoCyte contains cytarabine, and should be disposed of in a manner consistent with local requirements.
Danish: DepoCyte indeholder cytarabin og skal bortskaffes i henhold til lokale retningslinjer.
English: Before DepoCyte is used the vial should be warmed to room temperature (18°C - 22°C) for at least 30 minutes.
Danish: Inden DepoCyte anvendes, skal hætteglasset varmes op til stuetemperatur (18-22 °C) i mindst 30 minutter.
English: Exchange of cerebrospinal fluid with isotonic sodium chloride solution has been carried out in a case of intrathecal overdose of free cytarabine and such a procedure may be considered in the case of DepoCyte overdose.
Danish: Udskiftning af cerebrospinalvæsken med isotonisk natriumkloridopløsning er udført i et tilfælde med intratekal overdosis af frit cytarabin og en sådan procedure kan overvejes i tilfælde af DepoCyte overdosering.
English: Very common: weakness, pyrexia Common: fatigue Very common: weakness, pyrexia, fatigue *Induction and Maintenance cycle lengths were 2 and 4 weeks, respectively, during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine.
Danish: Meget almindelig: svaghed, feber Almindelig: træthed Meget almindelig: svaghed, feber, træthed * Induktions- og vedligeholdelsesperioderne var henholdsvis 2 og 4 uger, hvor patienten modtog enten 1 dosis DepoCyte eller 4 doser cytarabin.
English: Table 3: Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients
Danish: Bivirkninger, der muligvis afspejler meningeal irritation, hos fase II-, III- og IVpatienter
English: Intrathecal administration of cytarabine may cause myelopathy (3%) and other neurologic toxicities sometimes leading to a permanent neurological deficit.
Danish: Intratekal indgift af cytarabin kan eventuelt medføre myelopati (3 %) og anden neurologisk toksicitet, der i nogle tilfælde fører til permanent neurologisk deficit.
English: DepoCyte is used in adults to kill lymphoma tumour cells.
Danish: DepoCyte bruges hos voksne til at dræbe lymfom svulstceller.
English: • in the event of accidental contact with the skin, exposed areas should be washed immediately with soap and water;
Danish: • I tilfælde af utilsigtet kontakt med huden bør de eksponerede områder vaskes omgående med vand
English: DepoCyte has the potential of producing serious neurological toxicity.
Danish: DepoCyte kan eventuelt medføre alvorlig neurologisk toksicitet.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem DepoCyte
English: The importance of concurrent dexamethasone administration should be emphasised at the initiation of each cycle of DepoCyte treatment.
Danish: Vigtigheden af samtidig indgift af dexamethason bør understreges ved initiering af hver cyklus med DepoCyte behandling.
English: Male patients undergoing DepoCyte treatment should use a reliable contraceptive method.
Danish: Mænd i DepoCyte behandling bør anvende en pålidelig præventionsmetode.
English: Since it is a single use vial and does not contain any preservative, the medicinal product should be used within 4 hours of withdrawal from the vial.
Danish: Da hætteglasset er til engangsbrug og ikke indeholder konserveringsmiddel, bør lægemidlet anvendes inden 4 timer efter optrækning fra hætteglasset.
English: Following administration by lumbar puncture, it is recommended that the patient should be instructed to lie flat for one hour.
Danish: Efter administration via lumbal punktur anbefales det, at patienten instrueres til at ligge fladt ned i en time.
English: Just before withdrawing DepoCyte, the vial should be gently inverted to mix the particles evenly.
Danish: Lige inden DepoCyte trækkes ud, skal hætteglasset forsigtigt vendes på hovedet, så partiklerne bliver ensartet blandet.
English: If your side effects get worse or you notice any new side effects, tell your doctor.
Danish: Hvis bivirkningerne bliver værre, eller du får nye bivirkninger, skal du fortælle det til lægen.
English: • Confusion
Danish: • Konfusion
English: Other medicines and DepoCyte
Danish: Brug af anden medicin og DepoCyte
English: Fertility studies to assess the reproductive toxicity of DepoCyte have not been conducted.
Danish: Der er ikke blevet fortaget fertilitetsstudier til vurdering af reproduktiv toksicitet for DepoCyte.
English: Encapsulated cytarabine concentrations and the counts of the lipid particles in which the cytarabine is encapsulated in followed a similar distribution pattern.
Danish: Koncentrationerne af indkapslet cytarabin og tællinger af lipidpartiklerne, hvori cytarabin er indkapslet fulgte et lignende fordelingsmønster.
English: Symptoms have included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or visual disturbances).
Danish: Symptomer har omfattet indvirkning på nervesystemet (f.eks. krampe, smerter, følelsesløshed og snurren, blindhed og synsforstyrrelser).
English: All patients receiving DepoCyte should be treated concurrently with dexamethasone to mitigate the symptoms of arachnoiditis.
Danish: Alle patienter, som får DepoCyte, skal samtidigt behandles med dexamethason for at mildne symptomerne på araknoiditis.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: The studies also demonstrated susceptibility of many solid tumour cell lines to cytarabine, particularly after longer periods of exposure to cytarabine.
Danish: Studierne viste også at mange massive tumorcelle-linier var følsomme overfor cytarabin, specielt efter længere tids påvirkning af cytarabin.
English: Anaphylactic reactions following intravenous administration of free cytarabine have been rarely reported.
Danish: Anafylaktiske reaktioner efter intravenøs indgift af frit cytarabin er kun sjældent rapporteret.
English: DepoCyte should be withdrawn from the vial immediately before administration; the medicinal product should be used within 4 hours of withdrawal from the vial.
Danish: DepoCyte skal trækkes ud af hætteglasset lige inden administrationen; dette lægemiddel skal anvendes i løbet af 4 timer efter, at det er trukket ud af hætteglasset.
English: It is not known whether cytarabine is excreted in human milk following intrathecal administration.
Danish: Det vides ikke, om cytarabin udskilles i modermælk efter intratekal indgift.
English: Administration of DepoCyte in combination with other neurotoxic chemotherapeutic agents or with cranial/spinal irradiation may increase the risk of neurotoxicity.
Danish: DepoCyte indgift i kombination med andre neurotoksiske kemoterapeutika eller med kraniel/spinal strålebehandling kan forøge risikoen for neurotoksicitet.
English: Do not use this medicine if you notice severe discolouration, a changed appearance or a defective container.
Danish: Denne medicin må ikke anvendes, hvis der observeres kraftig misfarvning eller ændret udseende, eller hvis beholderen er defekt.
English: Preparation of DepoCyte Given its toxic nature, special precautions should be taken in handling DepoCyte.
Danish: Givet dets toksiske beskaffenhed bør der tages specielle forholdsregler ved håndteringen af DepoCyte.
English: During the 1 month Induction phase of treatment, DepoCyte was administered intrathecally as 50 mg every 2 weeks, and unencapsulated cytarabine as 50 mg twice a week.
Danish: I induktionsfasens behandling af 1 måneds varighed blev DepoCyte givet intratekalt i en dosis på 50 mg hver 2. uge og uindkapslet cytarabin 50 mg 2 gange om ugen.
English: Type I glass vial closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal containing 50 mg cytarabine in 5 ml suspension.
Danish: Type 1 hættglas, der er lukket med en fluororesinbeklædt butylgummiprop, forseglet med en aluminiums flip-off kapsel og indeholder 50 mg cytarabin i 5 ml suspension.
English: Because of possible excretion in human milk and because of the potential for serious adverse reactions in nursing infants, the use of DepoCyte is not recommended in breast-feeding women.
Danish: På grund af mulig udskillelse i modermælken, og da der er en potentiel risiko for alvorlige bivirkninger hos diende spædbørn, anbefales DepoCyte ikke til ammende kvinder.
English: Common: somnolence Common: somnolence
Danish: Almindelig: somnolens Almindelig: somnolens
English: Radiolabels for cytarabine and DOPC were distributed rapidly throughout the neuraxis.
Danish: Radioaktivt mærket cytarabin og DOPC blev hurtigt fordelt overalt i centralnervesystemet.
English: Vials should be allowed to warm to room temperature (18°C -22°C) for a minimum of 30 minutes and be gently inverted to resuspend the particles immediately prior to withdrawal from the vial.
Danish: Hætteglas bør have mulighed for at blive varmet op til stuetemperatur (18 - 22 °C) i mindst 30 minutter og bør vendes blidt for at genfordele partiklerne, umiddelbart før væsken trækkes op af hætteglasset.
English: The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination with other chemotherapeutic agents.
Danish: Bivirkningerne af DepoCyte kan bliver mere alvorlige, når DepoCyte gives sammen med andre kemoterapeutiske midler.
English: Cytarabine is a cell-cycle phase specific antineoplastic agent, affecting cells only during the S-phase of cell division.
Danish: Cytarabin er et cellecyklusfase specifikt antineoplastisk middel, som kun påvirker celler i løbet af celledelingens S-fase.
English: Cytarabine patients not completing all 4 doses within a cycle are counted as a complete cycle.
Danish: Cytarabin-patienter, der ikke gennemførte alle 4 doser inden for en periode, er talt som en hel periode.
English: Transient elevations in CSF protein and white blood cells have been observed in patients following DepoCyte administration, and have also been noted after intrathecal treatment with methotrexate or cytarabine.
Danish: Midlertidig forhøjelse af CSF-protein og hvide blodlegemer er blevet observeret hos patienter efter indgift af DepoCyte, og er ogstå blevet observeret efter intratekal behandling med methotrexat eller cytarabin.
English: Vigorous shaking should be avoided.
Danish: Kraftig omrystning bør undgås.
English: Τηλ: +44 (0) 1628 530554
Danish: Ηνωμένο Βασίλειο Τηλ: +44 (0) 1628 530554
English: What you need to know before you are given DepoCyte DepoCyte should not be given
Danish: Det skal du vide, inden du får DepoCyte
English: No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted.
Danish: Der er ikke udført formelle undersøgelser af farmakokinetiske lægemiddelinteraktioner mellem DepoCyte og andre lægemidler.
English: Cytarabine, when administered intrathecally, has been associated with nausea, vomiting and serious central nervous system toxicity which can lead to a permanent deficit, this includes blindness, myelopathy and other neurological toxicity.
Danish: Ved intratekal indgift har cytarabin været forbundet med kvalme, opkastning og alvorlig toksicitet i centralnervesystemet, der kan føre til permanent deficit, herunder blindhed, myelopati samt anden neurologisk toksicitet.
English: Intrathecal treatment of lymphomatous meningitis.
Danish: Intratekal behandling af lymfomatøs meningitis.
English: No studies assessing the impact of cytarabine on fertility are available in the literature.
Danish: Der er ingen studier tilgængelige i litteraturen, der belyser cytarabins virkning på fertiliteten.
English: In an open-label non-comparative dose escalation study in 18 paediatric patients (4 to 19 years) with leukaemic meningitis or neoplastic meningitis due to primary brain tumour, an intrathecal dose of 35 mg was identified as the maximum tolerated dose.
Danish: I et åbent, ikke-sammenlignende dosisoptrapningsstudie omfattende 18 pædiatriske patienter (4-19 år) med leukæmisk meningitis eller neoplastisk meningitis forårsaget af primær hjernetumor blev en intratekal dosis på 35 mg identificeret som den maksimalt tålte dosis.
English: DepoCyte patients received a median of 5 cycles (doses) per patient (range 1 to 10 doses) with a median time on therapy of 90 days (range 1 to 207 days).
Danish: DepoCyte patienterne fik en median på 5 perioder (doser) pr. patient (spændvidde 1 til 10 doser) med en median behandlingstid på 90 dage (spændvidde 1 til 207 dage).
English: DepoCyte is a sterile white to off-white-suspension.
Danish: DepoCyte er en steril hvid til råhvid suspension.
English: An overdose with DepoCyte may be associated with severe arachnoiditis including encephalopathy.
Danish: Overdosering af DepoCyte kan være forbundet med svær araknoiditis heri medregnet encephalopati.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Danish: 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: C. ANDRE FORHOLD OG BETINGELSERFOR MARKEDSFØRINGSTILLADELSEN
English: Cytarabine (n = 99 cycles)
Danish: Cytarabin (n = 99 perioder)
English: Systemic exposure to cytarabine was determined to be negligible following intrathecal administration of 50 mg and 75 mg of DepoCyte.
Danish: Systemisk cytarabinksponering er fastslået som værende ubetydelig efter intratekal indgift af 50 og 75 mg DepoCyte.
English: In contrast with systemically administered cytarabine which is rapidly metabolised to ara-U, conversion to ara-U in the CSF is negligible after intrathecal administration because of the significantly lower cytidine deaminase activity in the CNS tissues and CSF.
Danish: I modsætning til systemisk administreret cytarabin, som hurtigt metaboliseres til ara-U, er omdannelsen til ara-U i cerebrospinalvæsken ubetydelig efter intratekal indgift p.g.a. den signifikant lavere cytidindeaminaseaktivitet i CNS-væv og cerebrospinalvæske.
English: Contents of the pack and other information What DepoCyte contains
Danish: Pakningsstørrelser og yderligere oplysninger DepoCyte indeholder
English: − The active substance is cytarabine.
Danish: − Aktivt stof: Cytarabin.
English: The transfer rate of cytarabine from CSF to plasma is slow and the conversion to uracil arabinoside (ara-U), the inactive metabolite, in the plasma is fast.
Danish: Fordelingshastigheden af cytarabin fra cerebrospinalvæske til plasma er langsom og omdannelsen til uracil arabinosid (ara-U), den inaktive metabolit i plasma, er hurtig.
English: The dose for adults is 50 mg (one vial of DepoCyte).
Danish: Dosis til voksne er 50 mg (et hætteglas DepoCyte).
English: No carcinogenicity, mutagenicity or impairment of fertility studies have been conducted with DepoCyte.
Danish: Der er ikke udført carcinogenicitets-, mutagenicitets- eller fertilitetsstudier med DepoCyte.
English: Unused medicinal product must be discarded and not used subsequently.
Danish: Ubrugt lægemiddel skal kasseres og må ikke bruges senere.
English: Cytarabine and methotrexate patients not completing all 4 doses are counted as a fraction of a cycle.
Danish: Cytarabin- og methotrexat-patienter, der ikke gennemførte alle 4 doser, er talt som en del af en periode.
English: Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leucopenia, thrombocytopenia and anaemia.
Danish: Systemisk toksicitet forårsaget af intravenøs indgift af cytarabin viser sig primært som knoglemarvssuppression med leukopeni, trombocytopeni og anæmi.
English: The distribution and clearance of cytarabine and of the predominant phospholipid component of the lipid particle (DOPC) following intrathecal administration of DepoCyte was evaluated in rodents.
Danish: Fordeling og eliminering af cytarabin og af den dominerende fosfolipidkomponent af lipidpartiklen (DOPC) efter intratekal indgift af DepoCyte er undersøgt hos gnavere.
English: cytarabine.
Danish: cytarabin.
English: • Fever
Danish: • Feber
English: No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been established.
Danish: Der er ikke påvist præcist afgrænsede interaktioner mellem DepoCyte indgivet intratekalt og andre lægemidler.
English: No overdoses with DepoCyte have been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering med DepoCyte.
English: Blockage or reduction of CSF flow may result in increased free cytarabine concentrations in the CSF with increased risk of neurotoxicity.
Danish: Blokering eller reduktion af cerebrospinalvæskestrømmen kan resultere i øget koncentration af frit cytarabin i cerebrospinalvæsken med øget risiko for neurotoksicitet.
English: In an open-label, active-controlled, multicentre clinical study, 35 patients with lymphomatous meningitis (with malignant cells found on CSF cytology) were randomised to intrathecal therapy with either DepoCyte (n=18) or unencapsulated cytarabine (n=17).
Danish: I et åbent aktivt kontrolleret, klinisk multicenterstudie blev 35 patienter med lymfomatøs meningitis (med maligne celler fundet ved spinalvæske cytologi) randomiseret til intratekal behandling med enten DepoCyte (n=18) eller uindkapslet cytarabin (n=17).
English: For the treatment of lymphomatous meningitis, the dose for adults is 50 mg (one vial) administered intrathecally (lumbar puncture or intraventricularly via an Ommaya reservoir).
Danish: Til behandling af lymfomatøs meningitis er dosis til voksne 50 mg (ét hætteglas) indgivet intratekalt (lumbalpunktur eller intraventrikulært via et Ommaya-reservoir).
English: Very common: Thrombocytopenia Very common: Thrombocytopenia
Danish: Meget almindelig: Trombocytopeni Meget almindelig: Trombocytopeni
English: Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture.
Danish: Cytarabin er cytotoksisk overfor en lang række prolifererende pattedyrceller i cellekultur.
English: The active ingredient, cytarabine, was mutagenic in in vitro tests and was clastogenic in vitro (chromosome aberrations and sister chromatid exchange in human leukocytes) and in vivo (chromosome aberrations and sister chromatid exchange assay in rodent bone marrow, mouse micronucleus assay).
Danish: Cytarabin, den aktive substans, er mutagent i in vitro tests og klastogent in vitro (kromosom aberrationer og søster kromatid udveksling i humane leukocytter) og in vivo (kromosom aberrationer og søster kromatid udveksling assay i gnaver-knoglemarv, muse micronucleus assay).
English: Nervous system disorders
Danish: Nervesystemet DepoCyte
English: AUCs of free and encapsulated cytarabine after ventricular injection of DepoCyte appeared to increase linearly with increasing dose, indicating that the release of cytarabine from DepoCyte and the pharmacokinetics of cytarabine are linear in human CSF.
Danish: Efter ventrikulær injektion af DepoCyte steg AUC for frit og indkapslet cytarabin lineært med stigende dosis, hvilket indikerer, at frigivelsen af cytarabin fra DepoCyte og cytarabins farmakokinetik er lineær i human cerebrospinalvæske.
English: Pharmacokinetic parameters of DepoCyte (75 mg) in neoplastic meningitis patients in whom the medicinal product was administered either intraventricularly or by lumbar puncture suggest that exposure to the active substance in the ventricular or lumbar spaces is similar regardless of the route of administration.
Danish: Farmakokinetiske parametre ved DepoCyte (75 mg) hos patienter med neoplastisk meningitis, hos hvem lægemidlet blev indgivet enten intraventrikulært eller ved lumbalpunktur, tyder på, at eksponeringen over for det aktive stof i ventrikulær- eller lumbalrum er ens uanset indgiftsvej.
English: Although significant systemic exposure to free cytarabine is not expected following intrathecal treatment, some effects on bone marrow function cannot be excluded.
Danish: Selvom der ikke forventes signifikant systemisk eksponering overfor frit cytarabin efter intratekal behandling, kan en vis påvirkning af knoglemarvsfunktionen ikke udelukkes.
English: Following administration by lumbar puncture, the patient should be instructed to lie flat for one hour.
Danish: Efter indgift ved lumbalpunktur, bør patienten instrueres til at ligge fladt ned en time.
English: Make sure you take as directed any dexamethasone tablets that you may have been prescribed, as they reduce the risk of unwanted effects caused by DepoCyte.
Danish: Hvis du har fået ordineret dexamethasontabletter, skal du sørge for at tage dem som anvist, da de reducerer risikoen for bivirkninger, forårsaget af DepoCyte.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Indberetning af bivirkninger Hvis du oplever bivirkninger, bør du tale med din læge eller sygeplejerske.
English: All patients should be started on dexamethasone 4 mg twice daily either orally or intravenously for 5 days beginning on the day of DepoCyte injection.
Danish: Alle patienter bør påbegynde behandling med dexamethason 4 mg 2 gange dagligt, enten oralt eller intravenøst, i 5 dage, startende på dagen for DepoCyte injektionen.
English: The CSF clearance rate of cytarabine is similar to the CSF bulk flow rate of 0.24 ml/min.
Danish: Elimineringshastigheden for cytarabin i cerebrospinalvæske er sammenlignelig med cerebrospinalvæske bulk flow hastigheden på 0,24 ml/min.
English: One ml of suspension contains 10 mg cytarabine.
Danish: 1 ml suspension indeholder 10 mg cytarabin.
English: България ТП Мундифарма Медикъл ООД
Danish: ТП Мундифарма Медикъл ООД Тел.
English: Common: visual disturbances, blindness Common: visual disturbances, blindness
Danish: Almindelig: synsforstyrrelser, blindhed Almindelig: synsforstyrrelser, blindhed
English: − Keep this leaflet.
Danish: − Gem indlægssedlen.
English: DepoCyte must not be administered by any other route of administration.
Danish: DepoCyte må ikke indgives via andre administrationsveje.
English: DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into the cerebrospinal fluid (CSF).
Danish: DepoCyte er en depotformulering af cytarabin udviklet til direkte indgift i cerebrospinalvæsken (CSF).
English: DepoCyte is supplied in individual cartons each containing one single-dose vial.
Danish: DepoCyte leveres enkeltvis i æsker; hver æske indeholder et hætteglas med én dosis.
English: The primary route of elimination of cytarabine is metabolism to the inactive compound ara-U, (1-β-Darabinofuranosyluracil or uracil arabinoside) followed by urinary excretion of ara-U.
Danish: Cytarabins primære eliminationsvej er omdannelse til den inaktive forbindelse ara-U (1-β-Darabinofuranosyluracil eller uracilarabinosid), fulgt af udskillelse af ara-U via urinen.
English: Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Table 2: Adverse reactions possibly reflecting neurotoxicities in Phase II, III, and IV patients receiving DepoCyte 50 mg (n = 99 cycles) or cytarabine ( n = 84 cycles)
Danish: Bivirkninger, der muligvis afspejler neurotoksiciteter hos fase II-, III- og IVpatienter, som får DepoCyte 50 mg (n = 99 perioder) eller cytarabin (n = 84 perioder)
English: DepoCyte should be withdrawn from the vial immediately before administration.
Danish: DepoCyte bør trækkes op af hætteglasset umiddelbart før indgift.
English: DepoCyte (n = 929 cycles)
Danish: DepoCyte (n = 929 perioder)