FrancophonIA/ELRC3.0 huggingface dataset:
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.
Icelandic: Þar að auki eykur lyfjaformið, í samanburði við óbundið cýtarabín, líffræðilegan helmingunartíma með margfeldinu 27 til 71, sem er þó háð leið lyfjagjafar og því hólfi sem sýni er tekið úr.
English: Common: visual disturbances, blindness Common: visual disturbances, blindness
Icelandic: Algengar: sjóntruflanir, blinda Algengar: sjóntruflanir, blinda
English: Male patients undergoing DepoCyte treatment should use a reliable contraceptive method.
Icelandic: Karlmenn sem fá DepoCyte-meðferð eiga að nota örugga getnaðarvörn.
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.
Icelandic: Öllum sjúklingum ætti að gefa dexametasón, 4 mg tvisvar á dag, annað hvort til inntöku eða í bláæð, í 5 daga frá fyrsta degi DepoCyte-gjafar.
English: Investigations
Icelandic: Rannsóknir
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.
Icelandic: Tímabundnar hækkanir á próteinum og hvítum blóðfrumum í heila- og mænuvökva hafa komið fram eftir DepoCyte gjöf og hafa einnig sést eftir innanbastsmeðferð með methotrexati eða cýtarabíni.
English: Tel: + 43 (0) 1 523 25 05 office@mundipharma.at
Icelandic: + 43 (0) 1 523 25 05 office@mundipharma.at
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).
Icelandic: Virka efnið cýtarabín, reyndist stökkbreytandi in vitro og var brotmyndandi in vitro (litningagallar og skipti á litningsþráðum í hvítum blóðkornum manna) og „in vivo“ (litningagallar og skipti á litningsþráðum í beinmerg nagdýra, músa-örkjarnagreining).
English: Toxic effects may be related to a single dose or to cumulative doses.
Icelandic: Eituráhrif geta komið fram eftir einn skammt eða uppsafnaða skammta.
English: What DepoCyte is and what it is given for What you need to know before you are given DepoCyte
Icelandic: Upplýsingar um DepoCyte og við hverju það er notað Áður en byrjað er að nota DepoCyte Hvernig nota á DepoCyte
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).
Icelandic: Niðurstöður bráðra og hálfbráðra eiturrannsókna hjá öpum bentu til þess að þeir þyldu vel DepoCyte gefið innan basts í allt að 10 mg skammti (sambærilegt við 100 mg skammt hjá mönnum).
English: • in the event of accidental contact with the skin, exposed areas should be washed immediately with soap and water;
Icelandic: Ef lyfið kemst af slysni í snertingu við húð, skal þvo hana þegar í stað með sápu og vatni
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.
Icelandic: Dreifing og úthreinsun cýtarabíns og hins mest áberandi fosfólípíð-hluta fituagnarinnar (DOPC), eftir innanbastsgjöf DepoCyte, voru metin í nagdýrum.
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.
Icelandic: Depocyte á að draga úr hettuglasinu rétt fyrir gjöf; nota skal lyfið innan 4 klst.
English: Tel: +34 91 3821870 infomed@mundipharma.es
Icelandic: +34 91 3821870 infomed@mundipharma.es
English: DepoCyte should be withdrawn from the vial immediately before administration.
Icelandic: DepoCyte á að draga úr hettuglasinu rétt fyrir notkun.
English: • A stiff or rigid neck
Icelandic: stífni eða stirðleika í hálsi
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.
Icelandic: Könnun á eiturefnafræðilegum gögnum, sem fyrir hendi eru varðandi fituinnihaldsefnin (DOPC og DPPG) og fosfólípíða, líkum þeim sem eru í DepoCyte, benda til að þess háttar fituefni þolist vel hjá ýmsum dýrategundum, jafnvel þegar þau eru gefin langtímum saman og í skömmtum sem eru á bilinu frá grömmum til kílóa.
English: • all items used during administration or cleaning should be placed in high risk, waste-disposal bags for high temperature incineration;
Icelandic: Öll áhöld, sem notuð eru við gjöf eða hreinsun, skal setja í poka fyrir hættulegan úrgang sem farga skal með brennslu við háan hita
English: Unused medicinal product must be discarded and not used subsequently.
Icelandic: Ónotuðu lyfi verður að farga og það má ekki nota síðar.
English: KBM Pharma OÜ Tel. +372 733 8080 kbmpharma@kbmpharma.eu
Icelandic: +372 733 8080 kbmpharma@kbmpharma.eu
English: SPECIAL STORAGE CONDITIONS
Icelandic: SÉRSTÖK VARNAÐARORÐ
English: Institute of Innovative Biomedical Technology Tel: +371 7 800810 info@ibti.lvoffice
Icelandic: +371 7 800810 info@ibti.lvoffice
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.
Icelandic: Í opinni skammtaaukandi rannsókn án samanburðar á 18 börnum (4 til 19 ára), með heilahimnubólgu samhliða hvítblæði eða heilahimnubólgu samhliða æxlisvexti af völdum upphaflegs heilaæxlis, kom í ljós að hámarks þolanlegur skammtur var 35 mg gefinn í mænuvökva.
English: Lymphomatous meningitis is a condition in which tumour cells have invaded the fluid or membranes that surround the brain and spinal cord.
Icelandic: Heilahimnubólga af völdum eitilkrabbameins er ástand þar sem eitilkrabbameinsfrumur hafa ráðist inn í vökvann eða himnurnar sem umlykja heilann og mænuna.
English: Table 3: Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients
Icelandic: Aukaverkanir sem mögulega sýna taugaeiturhrif hjá sjúklingum í II., III. og IV.
English: Although significant systemic exposure to free cytarabine is not expected following intrathecal treatment, some effects on bone marrow function cannot be excluded.
Icelandic: Þó ekki sé vænst marktækrar, almennrar dreifingar á óbundnu cýtarabíni eftir innanbastsgjöf, er ekki hægt að útiloka einhver áhrif á starfsemi beinmergs.
English: Ear and labyrinth disorders
Icelandic: Eyru og völundarhús DepoCyte
English: − if you are allergic to cytarabine or any of the other ingredients of this medicine (listed in − if you have a meningeal infection.
Icelandic: − ef þú ert með ofnæmi fyrir cýtarabíni eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: DepoCyte must not be administered by any other way.
Icelandic: DepoCyte má ekki gefa með neinni annarri aðferð.
English: One ml of suspension contains 10 mg cytarabine.
Icelandic: Einn ml af dreifu inniheldur 10 mg cýtarabín.
English: Administration of DepoCyte in combination with other neurotoxic chemotherapeutic agents or with cranial/spinal irradiation may increase the risk of neurotoxicity.
Icelandic: DepoCyte-gjöf, í tengslum við önnur krabbameinslyf, sem hafa eiturvirkni í taugakerfi, eða í tengslum við höfuð- eða mænugeislun, getur aukið hættuna á eiturvirkni í taugakerfi.
English: − If you have further questions, ask your doctor.
Icelandic: − Leitið til læknisins ef þörf er á frekari upplýsingum.
English: Each 5 ml vial contains 50 mg cytarabine.
Icelandic: Hvert 5 ml hettuglas inniheldur 50 mg af cýtarabíni.
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.
Icelandic: DepoCyte skal gefa með hægri inngjöf á 1-5 mínútum beint inn í heila- eða mænuvökvann, annað hvort um lyfjabrunn í heilahólfi eða með beinni inndælingu í mænugöng.
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.
Icelandic: Þar eð DepoCyte agnir eru líkar hvítum blóðkornum að stærð og útliti, verður að gæta varúðar við túlkun á heila- og mænuvökvarannsókn eftir gjöf.
English: Also contains: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, water for injections.
Icelandic: Inniheldur einnig: kólesteról, tríóleín, díóleóýlfosfatídýlkólín, dípalmitóýlfosfatídýlglýseról, natríumklóríð, vatn fyrir stungulyf.
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.
Icelandic: Þar eð almenn dreifing óbundins cýtarabíns eftir innanbastsmeðferð með DepoCyte var óveruleg, er sennilegt að hætta á frjósemistruflun sé lítil.
English: Arachnoiditis is a syndrome manifested primarily by nausea, vomiting, headache and fever.
Icelandic: Lyfjaorsökuð skúmbólga er heilkenni sem einkennist fyrst og fremst af ógleði, uppköstum, höfuðverk og sótthita.
English: DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into the cerebrospinal fluid (CSF).
Icelandic: DepoCyte er hæglosunarform af cýtarabíni, ætlað til beinnar gjafar í heila- og mænuvökva (CSF).
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%).
Icelandic: Tíðni þessara aukaverkana, sem mögulega endurspegla mengisertingu er; höfuðverkur (24%), ógleði (18%), uppköst (17%), sótthiti (12%), hnakkastífleiki (3%), hálsverkir (4%) bakverkir (7%), mengiserting (< 1%), krampar (6%), vatnshöfuð (2%) og frumufjölgun í mænuvökva, með eða án breytinga á meðvitundarstigi (1%).
English: − The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.
Icelandic: Önnur innihaldsefni eru kólesteról, tríóleín, díóleóýlfosfatídýlkólín, dípalmítóýlfosfatídýlglýseról, natríumklóríð og vatn fyrir stungulyf.
English: Preparation of DepoCyte Given its toxic nature, special precautions should be taken in handling DepoCyte.
Icelandic: Vegna eiturverkunar DepoCyte skal gera sérstakar varúðarráðstafanir við meðhöndlun þess .
English: Arachnoiditis, a very common adverse reaction associated with DepoCyte, is a syndrome manifested by several adverse reactions.
Icelandic: Skúmbólga, sem er mjög algeng aukaverkun við notkun DepoCyte, er heilkenni sem lýsir sér með mörgum aukaverkunum..
English: Concern for foetal harm following intrathecal DepoCyte administration however, is low because systemic exposure to cytarabine is negligible.
Icelandic: Hættan á fósturskaða eftir innanbastsgjöf DepoCyte er hinsvegar lítil þar sem altæk útsetning fyrir cýtarabíni er hverfandi.
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.
Icelandic: Athugun á fyrirliggjandi gögnum um lyfjahvörf sýnir að eftir innanbastsgjöf á DepoCyte hjá sjúklingum, annað hvort með mænustungu eða með lyfjabrunni í heilahólfi, koma fram toppar af óbundnu cýtarabíni innan 5 klst., bæði í heilahólfi og í mænugöngum.
English: Mundipharma Tel: +33 (0) 1 40 65 29 29 infomed@mundipharma.fr
Icelandic: +33 (0) 1 40 65 29 29 infomed@mundipharma.fr
English: Store in a refrigerator (2ºC - 8ºC).
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið í kæli (2°C - 8°C).
English: The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination with other chemotherapeutic agents.
Icelandic: DepoCyte geta verið alvarlegri ef það er gefið samhliða öðrum krabbameinslyfjum.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Icelandic: Lesið allan fylgiseðilinn vandlega áður en byrjað er að nota lyfið.
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.
Icelandic: Greint hefur verið frá alvarlegum eituráhrifum á miðtaugakerfið eftir innanbastsgjöf DepoCyte, þar á meðal eru viðvarandi krampar (7%), mikil svefnhöfgi (3%), helftarlömun (1%), sjóntruflanir eða blinda (1%), heyrnarleysi (3%) og heilataugalömun (cranial nerve palsies) (3%).
English: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.
Icelandic: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, Bretland.
English: There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
Icelandic: Skýrslur sem afdráttarlaust tengja verkun DepoCyte-meðferðar við hæfni til aksturs eða notkunar véla hafa ekki verið birtar.
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).
Icelandic: Til meðferðar á mengisbólgu af völdum eitilkrabbameins er skammturinn 50 mg (eitt hettuglas) fyrir fullorðna gefinn innanbasts (með mænuástungu eða í heilahólf um Ommaya-lyfjabrunn).
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%).
Icelandic: Algengustu aukaverkanir tengdar DepoCyte, sem greint var frá í 1. til 4. stigs rannsóknum, voru höfuverkur (23%), skúmbólga (16%), sótthiti (14%), magnleysi (13%), ógleði (13%), uppköst (12%), ringlun (11%), niðurgangur (11%), blóðflagnafæð (10%) og þreyta (6%).
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).
Icelandic: Mjög algengar (koma fyrir hjá meira en 1 af hverjum 10 notendum), algengar (koma fyrir hjá 1 til 10 af hverjum 100 notendum), sjaldgæfar (koma fyrir hjá 1 til 10 af hverjum 1.000 notendum), mjög sjaldgæfar (koma fyrir hjá 1 til 10 af hverjum 10.000 notendum), koma örsjaldan fyrir (koma fyrir hjá minna en 1 af hverjum 10.000 notendum), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Mundipharma Pharmaceuticals Limited Tel: +353 1 2063800 oncologymedinfo@napp.co.uk
Icelandic: +353 1 2063800 oncologymedinfo@napp.co.uk
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%).
Icelandic: Einkenni úttaugakvilla s.s. verkir (1%), dofi (3%), náladofi (3%), minnkað snertiskyn (2%), magnleysi (13%) og skert stjórn á hægðum (3%) og þvaglátum (þvagleki) (1%) hafa einnig komið fram og í sumum tilfellum hefur verið tilkynnt um þessa samsetningu taugafræðilegra einkenna sem Cauda equina heilkenni (3%).
English: Тел.
Icelandic: OÜ Tel.
English: - o.z Tel: +421 2 63811611 mundipharma@mundipharma.sk
Icelandic: +421 2 63811611 mundipharma@mundipharma.sk
English: Cytarabine
Icelandic: Cýtarabín
English: Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.
Icelandic: Einnig hefur verið tilkynnt um vatnshöfuð, hugsanlega af völdum skúmbólgu.
English: Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Icelandic: 50 mg gefin á 28 daga fresti, fjórum sinnum (í viku 17, 21, 25 og 29).
English: DepoCyte administration
Icelandic: Meðhöndlun DepoCyte
English: In the event of accidental contact with the mucous membranes, treat immediately by copious washing with water; medical attention should be sought.
Icelandic: Ef lyfið kemst af slysni í snertingu við slímhúð, skal skola hana þegar í stað með miklu magni af vatni; leita skal læknis.
English: Other medicines and DepoCyte
Icelandic: Notkun annarra lyfja samhliða DepoCyte
English: Mundipharma Comm VA.
Icelandic: Luxembourg/Luxemburg Mundipharma Comm VA.
English: No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted.
Icelandic: Formlegt mat á lyfjahvarfafræðilegum milliverkunum milli DepoCyte og annarra lyfja hefur ekki verið gert.
English: No overdoses with DepoCyte have been reported.
Icelandic: Engar upplýsingar liggja fyrir um ofskömmtun DepoCyte.
English: Following administration by lumbar puncture, the patient should be instructed to lie flat for one hour.
Icelandic: Eftir gjöf með mænustungu ætti að gefa sjúklingnum fyrirmæli um að liggja flatur í 1 klst.
English: DepoCyte 50 mg suspension for injection Cytarabine
Icelandic: DepoCyte 50 mg stungulyf, dreifa Cýtarabín
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform the medical staff looking after you.
Icelandic: Látið lækninn eða lyfjafræðing vita ef vart verður við aukaverkanir sem ekki er minnst á í þessum fylgiseðli eða ef aukaverkanir sem taldar eru upp reynast alvarlegar.
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.
Icelandic: Væg til meðalmikil bólga fannst í himnum mænu og heila og/eða virkjun stjarnfrumna hjá dýrum sem fengu innanbasts DepoCyte.
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.
Icelandic: Lyfjahvarfabreytur DepoCyte (75 mg) hjá sjúklingum með heilahimnubólgu af völdum æxlis, sem hafa fengið lyfið í heilahólf eða með mænustungu, gefa til kynna að dreifing virka efnisins í heilahólf og í mænugöng sé svipuð hver sem leið lyfjagjafar er.
English: DepoCyte (n = 929 cycles) Methotrexate (n = 258 cycles) Cytarabine (n = 99 cycles)
Icelandic: Methotrexat (n = 258 lotur) Cýtarabín (n = 99 lotur)
English: Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Icelandic: Viðhaldsmeðferð: gefið úr einu hettuglasi af DepoCyte (50 mg) á 28 daga fresti, fjórum sinnum (þ.e. í viku 17, 21, 25 og 29).
English: Concomitant administration of DepoCyte with other antineoplastic agents administered by the intrathecal route has not been studied.
Icelandic: Samtímis gjöf DepoCyte og annarra æxlislyfja innan basts hefur ekki rannsökuð.
English: A qualified and experienced doctor or physician in the treatment of cancer will inject DepoCyte in the spinal fluid or lumber sac.
Icelandic: Sérfræðingur með reynslu af krabbameinsmeðferð mun dæla DepoCyte í mænuvökvann.
English: Mundipharma Pharmaceuticals Ltd Τηλ: +357 22 81 56 56 info@mundipharma.com.cy
Icelandic: +357 22 81 56 56 info@mundipharma.com.cy
English: Suomi/Finland
Icelandic: Suomi/Finland Mundipharma
English: België/Belgique/Belgien
Icelandic: België/Belgique/Belgien Mundipharma Comm VA.
English: • Persistent or extreme sleepiness
Icelandic: þrálátri eða mjög mikilli syfju
English: Encapsulated cytarabine concentrations and the counts of the lipid particles in which the cytarabine is encapsulated in followed a similar distribution pattern.
Icelandic: Þéttni húðaðs cýtarabíns og talning fituagna, sem innihalda cýtarabínið húðað, hafa líka dreifingarmynd.
English: Medis Hungary Kft Információsvonal: +36 2 380 1028 info@medis.hu
Icelandic: +36 2 380 1028 info@medis.hu
English: There is no antidote for intrathecal DepoCyte or unencapsulated cytarabine released from DepoCyte.
Icelandic: Móteitur gegn DepoCyte gjöf í heilahólf, eða gegn losun óhúðaðs cýtarabíns sem losnar úr DepoCyte, er ekki til.
English: Mundipharma GmbH Tel: + 49 (0) 64 31 701-0 mundipharma@mundipharma.de
Icelandic: + 49 (0) 64 31 701-0 mundipharma@mundipharma.de
English: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP United Kingdom
Icelandic: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP Bretland
English: The recommended dose will be given to you by the doctor or physician as necessary.
Icelandic: Ef stærri skammtur en mælt er fyrir um er notaður Læknir þinn mun gefa þér þann skammt sem mælt er með að gefa, eins og nauðsynlegt er.
English: DepoCyte is a sterile white to off-white-suspension.
Icelandic: DepoCyte er sæfð hvít til beinhvít dreifa.
English: Mundipharma AB Tel: + 46 (0)31 773 75 30 info@mundipharma.se
Icelandic: + 46 (0)31 773 75 30 info@mundipharma.se
English: Mundipharma Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
Icelandic: Česká republika Mundipharma Ges.m.b.H. Austria Organizační složka ČR Tel : +420 222 318 221 office@mundipharma.cz
English: Tél/Tel: +32 (0) 15 45 11 80 info@mundipharma.be
Icelandic: +32 (0) 15 45 11 80 info@mundipharma.be
English: Common: deafness Common: deafness
Icelandic: Algengar: þvagleki Algengar: þvagleki
English: The following protective recommendations are given due to the toxic nature of this substance:
Icelandic: Mælt er með eftirfarandi varúðarráðstöfunum vegna eitureiginleika þessa efnis.
English: In-line filters must not be used when administering DepoCyte.
Icelandic: Ekki má nota slöngur með síum þegar verið er að gefa DepoCyte.
English: Mundipharma AS Tlf: +47 67 51 89 00 post@mundipharma.no
Icelandic: +47 67 51 89 00 post@mundipharma.no
English: It should not be shaken vigorously.
Icelandic: Ekki má þynna dreifuna.
English: DepoCyte is a white to off-white-suspension for injection supplied in a glass vial.
Icelandic: DepoCyte er hvítt til beinhvítt stungulyf, dreifa í hettuglasi úr gleri.
English: After first opening: from a microbiological point of view, the product should be used immediately.
Icelandic: Frá örverufræðilegu sjónarmiði ætti að nota lyfið strax eftir að umbúðir eru fyrst opnaðar.
English: Mundipharma Ges.m.b.H.
Icelandic: Slovenská republika Mundipharma Ges.m.b.H. - o.z
English: Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).
Icelandic: Byrjunarmeðferð: gefið úr einu hettuglasi af DepoCyte (50 mg) á 14 daga fresti, tvisvar (þ.e. í viku 1 og viku 3).
English: Intrathecal co-administration of cytarabine with other cytotoxic agents may increase the risk of neurotoxicity.
Icelandic: Samtímis gjöf cýtarabíns og annarra frumudrepandi efna getur aukið hættu á eiturverkun í taugakerfi.
English: In contrast, intrathecal administration of 30 mg free cytarabine has shown a biphasic CSF concentration profile with a terminal phase half-life of about 3.4 hours.
Icelandic: Andstætt þessu hefur innanbastsgjöf á 30 mg af óbundnu cýtarabíni sýnt tvíþrepa þéttnimynd í heila- og mænuvökva með helmingunartíma í lokaþrepi um 3,4 klst.