FrancophonIA/ELRC3.0 huggingface dataset:
English: DepoCyte is to be administered by slow injection over a period of 1-5 minutes directly into the cerebrospinal fluid (CSF) via either an intraventricular reservoir or by direct injection into the lumbar sac.
Danish: DepoCyte skal indgives som langsom injektion i løbet af 1-5 minutter direkte i cerebrospinalvæsken (CSF) enten via et intraventrikulært reservoir eller ved direkte injektion i lumbalsækken.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA <PC: {nummer} [produktkode]
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10,000); not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af mulige bivirkninger, der står opført nedenfor, klassificeres på følgende måde: meget almindelig (rammer mere end 1 bruger ud af 10); almindelig (rammer 1 til 10 brugere ud af 100); ikke almindelig (rammer 1 til 10 brugere ud af 1.000); sjælden (rammer 1 til 10 brugere ud af 10.000); meget sjælden (rammer mindre end 1 bruger ud af 10.000); vides ikke (hyppighed kan ikke vurderes ud fra de tilgængelige data).
English: Very common: headache Common: convulsions, hydrocephalus acquired, CSF pleocytosis
Danish: Almindelig: krampe, erhvervet hydrocephalus, CSF pleocytosis
English: Concern for foetal harm following intrathecal DepoCyte administration however, is low because systemic exposure to cytarabine is negligible.
Danish: Risiko for fosterskade efter intratekal indgift af DepoCyte er imidlertid lav, fordi systemisk eksponering for cytarabin er ubetydelig.
English: • in the event of accidental contact with the mucous membranes, exposed areas should be treated immediately by copious lavage with water; medical attention should be sought.
Danish: • I tilfælde af kontakt med slimhinder, bør de eksponerede områder behandles øjeblikkeligt med skylning med rigeligt vand og der bør søges lægehjælp.
English: Despite the low apparent risk women of childbearing potential should not receive treatment until pregnancy is excluded and should be advised to use a reliable contraceptive method.
Danish: Til trods for den tilsyneladende lave risiko bør behandling ikke gives til fertile kvinder, før graviditet er udelukket, og kvinderne skal rådes til at anvende sikker antikonception.
English: DepoCyte is used to treat lymphomatous meningitis.
Danish: DepoCyte anvendes til behandling lymfomatøs meningitis.
English: DepoCyte must not be mixed with any other medicinal products (see section 6.2).
Danish: DepoCyte må ikke blandes med andre lægemidler (se pkt.
English: Cytarabine
Danish: Cytarabin
English: Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, United Kingdom.
Danish: Fremstiller Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, Storbritannien.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: 5.1 Farmakodynamiske egenskaber
English: Each vial contains 50 mg cytarabine (10 mg/ml).
Danish: Hvert 5 ml-hætteglas indeholder 50 mg cytarabin (10 mg/ml).
English: The incidence of these adverse reactions, possibly reflecting meningeal irritation, are headache (24%), nausea (18%), vomiting (17%), pyrexia (12%), neck stiffness (3%), neck pain (4%), back pain (7%), meningism (<1%), convulsions (6%), hydrocephalus (2%), and CSF pleocytosis with or without altered state of consciousness (1%).
Danish: Forekomsten af disse bivirkninger, der muligvis afspejler meningeal irritation, er hovedpine (24 %), kvalme (18 %), opkastning (17 %), feber (12 %), nakkestivhed (3 %), nakkesmerter (4 %), rygsmerter (7 %), meningismus (< 1 %), krampe (6 %), hydrocephalus (2 %), og CSF pleocytose med eller uden ændret bevidsthedstilstand (1 %).
English: Adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1-4 study patients with lymphomatous meningitis receiving DepoCyte 50 mg (n = 151 cycles) or cytarabine (n = 99 cycles)
Danish: Bivirkninger, der forekom i > 10 % af perioderne hos patienter med lymfomatøs meningitis i begge behandlingsgrupper i fase 1-4-patienter, som fik DepoCyte 50 mg (n = 151 perioder) eller cytarabin (n = 99 perioder)
English: Very common: diarrhoea, vomiting, nausea Very common: diarrhoea, vomiting, nausea
Danish: Meget almindelig: diarré, opkastning, kvalme Meget almindelig: diarré, opkastning, kvalme
English: If left untreated, chemical arachnoiditis may be fatal.
Danish: Kemisk araknoiditis kan være dødbringende, hvis den ikke behandles.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intratekal anvendelse
English: Common: urinary incontinence Common: urinary incontinence
Danish: Almindelig: urininkontinens Almindelig: urininkontinens
English: Patients with active meningeal infection.
Danish: Patienter med aktiv meningitis.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: DepoCyte Cytarabine
Danish: Øjne DepoCyte Cytarabin
English: The following regimen of induction, consolidation and maintenance therapy is recommended: Induction therapy: 50 mg administered every 14 days for 2 doses (weeks 1 and 3).
Danish: Følgende regime anbefales til induktions-, konsoliderings- og vedligeholdelsesbehandling: Induktionsbehandling: 50 mg indgivet hver 14. dag; administreres 2 gange (uge 1 og 3).
English: Methotrexate (n = 258 cycles)
Danish: Methotrexat (n = 258 perioder)
English: Patients receiving DepoCyte should be concurrently treated with corticosteroids (e.g. dexamethasone) to mitigate the symptoms of arachnoiditis (see section 4.8), which is a very common adverse reaction.
Danish: Patienter, der får DepoCyte, bør samtidig behandles med kortikosteroider (f.eks. dexamethason) for at lindre symptomerne på araknoiditis (se pkt.
English: These peaks were followed by a biphasic elimination profile consisting of an initial sharp decline and subsequent slow decline with a terminal phase half-life of 100 to 263 hours over a dose-range of 12.5 mg to 75 mg.
Danish: Toppene følges af en bifasisk eliminationsprofil bestående af et initialt brat fald efterfulgt af et langsomt fald med en terminalfase- halveringstid på 100 - 263 timer ved et dosisinterval på 12,5 mg til 75 mg. I modsætning hertil viste intratekal indgift af 30 mg frit cytarabin en bifasisk cerebrospinalvæske koncentrationsprofil med en terminalfasehalveringstid på ca. 3,4 timer.
English: DepoCyte 50 mg suspension for injection Cytarabine
Danish: DepoCyte 50 mg injektionsvæske, suspension Cytarabin
English: DepoCyte must not be administered by any other way.
Danish: DepoCyte må ikke indgives på nogen anden måde.
English: Suspension for injection.
Danish: Vand til injektionsvæsker
English: Analysis of the available pharmacokinetic data shows that following intrathecal DepoCyte administration in patients, either via the lumbar sac or by intraventricular reservoir, peaks of free cytarabine were observed within 5 hours in both the ventricle and lumbar sac.
Danish: Analyse af de tilgængelige farmakokinetiske data viser imidlertid, at der ses toppe af frit cytarabin indenfor 5 timer både i ventriklen og lumbalsækken efter intratekal DepoCyte indgift hos patienter enten via lumbalsækken eller via et intraventrikulært reservoir.
English: Concomitant administration of DepoCyte with other antineoplastic agents administered by the intrathecal route has not been studied.
Danish: Samtidig indgift af DepoCyte og andre intratekale antineoplastiske lægemidler indgivet intratekalt er ikke undersøgt.
English: <2D barcode carrying the unique identifier included.>
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.> <Ikke relevant.>
English: For cell-cycle phase specific antimetabolites the duration of exposure of neoplastic cells to cytotoxic concentrations is an important determination of efficacy.
Danish: Eksponeringsvarigheden af cytotoksiske koncentrationer på neoplastiske celler er vigtig for effekten af cellecyklusfase-specifikke antimetabolitter.
English: Reporting of side effects
Danish: Indberetning af formodede bivirkninger
English: Intrathecal use
Danish: Intratekal anvendelse
English: DepoCyte is administered directly into the CSF via an intraventricular reservoir or by direct injection into the lumbar sac.
Danish: DepoCyte indgives direkte i cerebrospinalvæsken via et intraventrikulært reservoir eller ved direkte injektion i lumbalsækken.
English: Intracellularly, cytarabine is converted into cytarabine-5'-triphosphate (ara-CTP), which is the active metabolite.
Danish: Cytarabin omdannes intracellulært til den aktive metabolit, cytarabin-5- triphosphat (ara-CTP).
English: Also contains: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, water for injections.
Danish: Indeholder også: cholesterol, triolein, dioleoylphosphatidylcholin, dipalmitoylphosphatidylglycerol, natriumchlorid, vand til injektionsvæsker.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed overfor det aktive stof eller over for et eller flere af hjælpestofferne, anført i pkt.
English: Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness
Danish: Almindelig: cauda equina-syndrom, konvulsioner, kranienerveparese, hypoæstesi, myelopati, paræstesi, ensidig lammelse, følelsesløshed Almindelig: cauda equina-syndrom, konvulsioner, kranienerveparese, hypoæstesi, myelopati, paræstesi, ensidig lammelse, følelsesløshed
English: The systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible.
Danish: Den systemiske eksponering overfor frit cytarabin efter intratekal DepoCyte behandling er ubetydelig.
English: • Pain, numbness or tingling (feeling of sensation of pins and needles)
Danish: • Smerter, følelsesløshed eller snurren (prikkende fornemmelse)
English: Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections
Danish: Dioleoylphosphatidylcholin (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Natriumchlorid
English: DepoCyte is a white to off-white-suspension for injection supplied in a glass vial.
Danish: Udseende og pakningsstørrelser DepoCyte er en hvid til råhvid suspension til injektion, der leveres i et hætteglas.
English: Very common: arachnoiditis, confusion, headache Very common: arachnoiditis, headache Common: confusion
Danish: Meget almindelig: araknoiditis, hovedpine Almindelig: konfusion
English: For Phase 1-4 studies in patients with lymphomatous meningitis receiving either DepoCyte or cytarabine adverse reactions are listed by MedDRA body system organ class and by frequency (Very common (≥1/10); and 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)) in Table 1 below.
Danish: For fase 1-4-studier af patienter med lymfomatøs meningitis, som enten fik DepoCyte eller cytarabin, anføres bivirkninger efter MedDRA-betegnelsen for systemorganklasse og efter hyppighed (meget almindelig (≥ 1/10); og almindelig (≥ 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)) i tabel 1 nedenfor.
English: • Weakness
Danish: • Svaghed
English: In the event of accidental contact with the mucous membranes, treat immediately by copious washing with water; medical attention should be sought.
Danish: I tilfælde af utilsigtet kontakt med slimhinder skal disse omgående vaskes med rigeligt vand, og der skal søges lægehjælp.
English: Following intrathecal administration of DepoCyte, serious central nervous system toxicity, including persistent convulsions (7%), extreme somnolence (3%), hemiplegia (1%), visual disturbances including blindness (1%), deafness (3%) and cranial nerve palsies (3%) have been reported.
Danish: Efter intratekal indgift af DepoCyte er der rapporteret alvorlig toksicitet i centralnervesystemet, herunder vedvarende konvulsioner (7 %), ekstrem somnolens (3 %), halvsidig lammelse (1 %), synsforstyrrelser, herunder blindhed (1 % ), døvhed (3 %) og kranienerveparese (3 %).
English: Cytarabine was clastogenic to meiotic cells; a dose-dependent increase in sperm-head abnormalities and chromosomal aberrations occurred in mice given intraperitoneal (i.p.)
Danish: Der opstod en dosis-afhængig forøgelse i spermahoved-abnormiteter og kromosom aberrationer hos mus, der fik intraperitoneal (i.p.)
English: Because the systemic exposure to free cytarabine following intrathecal treatment with DepoCyte is negligible, the risk of impaired fertility is likely to be low (see section 5.3).
Danish: Da systemisk eksponering for frit cytarabin efter intratekal behandling med DepoCyte er ubetydelig, er risiko for nedsat fertilitet sandsynligvis lav (se pkt.
English: − If you have further questions, ask your doctor.
Danish: − Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: Intrathecal co-administration of cytarabine with other cytotoxic agents may increase the risk of neurotoxicity.
Danish: Samtidig intratekal indgift af cytarabin og andre intratekale cytotoksiske lægemidler kan eventuelt øge risikoen for neurotoksicitet.
English: Mundipharma Oy Puh/Tel: +358 (0)9 8520 2065 info@mundipharma.fi
Danish: Suomi/Finland Mundipharma Oy Puh/Tel: +358 (0)9 8520 2065 info@mundipharma.fi
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET PÅ HÆTTEGLAS
English: − The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.
Danish: − Øvrige indholdsstoffer: cholesterol, triolein, dioleoylphosphatidylcholin, dipalmitoylphosphatidylglycerol, natriumchlorid og vand til injektionsvæsker.
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
English: One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving DepoCyte intraventricularly.
Danish: I et tidligt ukontrolleret studie uden dexamethason-profylakse, blev der indgivet enkeltdoser op til 125 mg. En patient på 125 mg niveauet døde af encephalopati 36 timer efter at have fået DepoCyte intraventrikulært.
English: Institute of Innovative Biomedical Technology Tel: +371 7 800810 info@ibti.lvoffice
Danish: Tel: +371 7 800810 info@ibti.lvoffice
English: In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache (23%), arachnoiditis (16%), pyrexia (14%), weakness (13%), nausea (13%), vomiting (12%), confusion (11%), diarrhoea (11%), thrombocytopenia (10%), and fatigue (6%).
Danish: I fase 1-4-studier var de hyppigste bivirkninger, der blev rapporteret i forbindelse med DepoCyte, hovedpine (23 %), araknoiditis (16 %), feber (14 %), svaghed (13 %), kvalme (13 %), opkastning (12 %),
English: − if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in − if you have a meningeal infection.
Danish: De må ikke få DepoCyte − hvis du er allergisk over for cytarabin eller et af de øvrige indholdsstoffer i denne medicin (jvf.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: Because the systemic exposure to free cytarabine following intrathecal treatment with DepoCyte was negligible, the risk of impaired fertility is likely to be low.
Danish: Da den systemiske eksponering overfor frit cytarabin efter intratekal DepoCyte behandling er ubetydelig, er risikoen for nedsat fertilitet sandsynligvis lille.
English: Symptoms and signs of peripheral neuropathy, such as pain (1%), numbness (3%), paresthesia (3%), hypoaesthesia (2%), weakness (13%), and impaired bowel (3%) and bladder control (incontinence) (1%), have also been observed and in some cases this combination of neurological signs and symptoms has been reported as Cauda equina syndrome (3%).
Danish: Symptomer og tegn på perifer neuropati, f.eks. smerter (1 %), følelsesløshed (3 %), paræstesi (3 %), hypoæstesi (2 %), svækkelse (13 %) og nedsat tarmkontrol (3 %) og blærekontrol (inkontinens) (1 %) er også observeret.
English: Therefore, as with any intrathecal cytotoxic therapy, consideration should be given to the need for assessment of CSF flow before treatment is started.
Danish: Derfor skal behovet for vurdering af cerebrospinalvæskestrømmen overvejes, inden behandling påbegyndes, som ved enhver intratekal cytotoksisk behandling.
English: Follow-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose at week 13.
Danish: Opfølgende behandling: Et hætteglas DepoCyte (50 mg) givet hver 14. dag i 3 doser (uge 5, 7 og 9) efterfulgt af yderligere en dosis i uge 13.
English: Adverse reactions possibly reflecting neurotoxicity are listed in Table 2 by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Danish: Bivirkninger, der muligvis afspejler neurotoksicitet, står opført i tabel 2 efter MedDRA- betegnelsen for systemorganklasse og efter hyppighed: Meget ualmindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); og Ikke almindelig (≥ 1/1.000 til < 1/100).
English: Posology
Danish: INDLÆGSSEDDEL
English: MARKETING AUTHORISATION NUMBER
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Consolidation therapy: 50 mg administered every 14 days for 3 doses (weeks 5, 7 and 9) followed by an additional dose of 50 mg at week 13.
Danish: Konsolideringsbehandling: 50 mg indgivet hver 14. dag; administreres 3 gange (uge 5, 7 og 9) og efterfølges af endnu en dosis på 50 mg i uge 13.
English: België/Belgique/Belgien
Danish: België/Belgique/Belgien Mundipharma Comm VA.
English: How to store DepoCyte
Danish: Sådan får du DepoCyte
English: Adverse reactions are listed by MedDRA body system organ class and by frequency: Very common (_≥1/10); Common (≥1/100 to < 1/10); and Uncommon (≥ 1/1,000 to < 1/100).
Danish: Birvirkninger står opført efter MedDRA-betegnelsen for systemorganklasse og efter hyppighed: Meget almindelig (≥ 1/10); Almindelig (≥ 1/100 til < 1/10); og Ikke almindelig (≥ 1/1.000 til < 1/100).
English: DepoCyte must only be administered by the intrathecal route.
Danish: DepoCyte må udelukkende indgives intratekalt.
English: Do not drive during treatment.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle under behandlingen.
English: Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).
Danish: Opstartsbehandling: Et hætteglas DepoCyte (50 mg) givet hver 14. dag i 2 doser (uge 1 og 3).
English: Mundipharma Ges.m.b.H.
Danish: Česká republika Mundipharma Ges.m.b.H.
English: DepoCyte 50 mg suspension for injection
Danish: LÆGEMIDLETS NAVN DepoCyte 50 mg injektionsvæske, suspension
English: Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Danish: Vedligeholdelsesbehandling: Et hætteglas DepoCyte (50 mg) givet hver 28. dag i 4 doser (ugerne 17, 21, 25 og 29).
English: DepoCyte should not be given to pregnant women as it may harm an unborn child. Women of childbearing potential should use a reliable contraceptive method to avoid pregnancy whilst being treated with DepoCyte.
Danish: Kvinder i den fødedygtige alder bør anvende pålidelige svangerskabsforebyggelsesmetoder for at undgå graviditet, mens de behandles med Depocyte.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER
English: Each 5 ml
Danish: Hvert 5 ml hætteglas
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet DepoCyte
English: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP United Kingdom
Danish: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP Storbritannien
English: If you are given more DepoCyte than you should
Danish: Hvis du har fået for meget DepoCyte:
English: Mundipharma Comm VA. Tél: +32 (0) 15 45 11 80 info@mundipharma.be
Danish: Luxembourg/Luxemburg Mundipharma Comm VA. Tél: +32 (0) 15 45 11 80 info@mundipharma.be
English: • Shaking
Danish: • Krampe
English: Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Danish: Vedligeholdelsesbehandling: 50 mg indgivet hver 28. dag; administreres 4 gange (uge 17, 21, 25 og
English: Tel : +420 222 318 221 office@mundipharma.cz
Danish: Austria Organizační složka ČR Tel : +420 222 318 221 office@mundipharma.cz
English: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.
Danish: Indehaver af markedsføringstilladelsen Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, Storbritannien.
English: Ear and labyrinth disorders
Danish: Øre og labyrint DepoCyte Cytarabin
English: Manufacturer
Danish: ETIKETTERING
English: Psychiatric disorders
Danish: Psykiske forstyrrelser DepoCyte
English: Uncommon: meningism Very common: headache Common: convulsions, hydrocephalus acquired, meningism
Danish: Almindelig: krampe, erhverved hydrocephalus, meningisme
English: Since DepoCyte's particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examination following administration.
Danish: Fortolkning af cerebrospinalvæskeundersøgelse efter indgift skal udføres omhyggeligt, da DepoCyte partikler ligner hvide blodlegemer i størrelse og udseende.
English: Very common: headache Common: convulsions, meningism
Danish: Almindelig: krampe, meningisme
English: Napp Pharmaceuticals Limited Tel: +44 (0) 1223 424444
Danish: United Kingdom Napp Pharmaceuticals Limited Tel: +44 (0) 1223 424444 oncologymedinfo@napp.co.uk
English: Very common: pyrexia Common: pyrexia Very common: pyrexia *Cycle length was 2 weeks during which the patient received either 1 dose of DepoCyte or 4 doses of cytarabine or methotrexate.
Danish: * Perioderne var på 2 uger, hvor patienten fik enten 1 dosis DepoCyte eller 4 doser cytarabin eller methotrexat.
English: • Convulsion
Danish: • Træthed
English: Mundipharma Pharmaceuticals B.V. Tel: +31 (0) 33 450 8270 info@mundipharma.nl
Danish: Tel: +31 (0) 33 450 8270 info@mundipharma.nl
English: Common: deafness Common: deafness
Danish: Meget almindelig: svaghed
English: One 5 ml vial.
Danish: 1 stk. 5 ml hætteglas
English: Mundipharma Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
Danish: Tel: +40 751 121 222 office@mundipharma.ro
English: DepoCyte
Danish: Amning
English: White to off-white suspension.
Danish: Injektionsvæske, suspension En hvid til råhvid suspension.
English: Common: impaired bowel control
Danish: Almindelig: nedsat tarmfunktion
English: A qualified and experienced doctor or physician in the treatment of cancer will inject DepoCyte in the spinal fluid or lumber sac.
Danish: DepoCyte bliver sprøjtet ind i rygmarvsvæsken eller i rygmarvshindesækken i lænden af en kompetent læge, der har erfaring i kræftbehandling.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret maj 2015
English: NAME OF THE MEDICINAL PRODUCT
Danish: FARMAKOLOGISKE EGENSKABER
English: These measures will help protect the environment.
Danish: Disse forholdsregler er med til at beskytte miljøet.