natgillin/translations-raw huggingface dataset:
To minimise these side effects, patients should receive a steroid (either orally or by injection) at the same time as the DepoCyte injection and they must also be closely monitored.
Za zmanjšanje neželenih učinkov morajo bolniki prejemati steroid (peroralno ali z injekcijo) hkrati z injekcijo zdravila DepoCyte ter jih je treba natančno spremljati.
For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila DepoCyte, glejte Navodilo za uporabo.
DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any other ingredient.
Zdravila DepoCyte ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) citarabin ali katero koli drugo sestavino zdravila.
It should not be used in patients who have an active infection of the meninges.
Ne sme se uporabljati pri osebah, ki imajo aktivno vnetje mening.
The Committee for Medicinal Products for Human use (CHMP) concluded that DepoCyte has shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that its administration schedule, with fewer intrathecal injections, can be of benefit to the patient ’ s quality of life.
Odbora za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo DepoCyte izkazalo učinkovitost pri limfomatoznem meningitisu v primerjavi s standardno obliko citarabina, ter da lahko njegova shema uporabe z manj intratekalnimi injekcijami prispeva k izboljšanju kakovosti bolnikovega življenja.
They concluded that DepoCyte’ s benefits outweigh its risks and recommended that the medicine be given marketing authorisation.
Odbor je sklenil, da so koristi zdravila DepoCyte večje od z njim povezanih tveganj, zato je priporočil odobritev dovoljenja za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union, for DepoCyte on 11 July 2001.
Evropska komisija je dovoljenje za promet z zdravilom DepoCyte, veljavno po celotni Evropski uniji, podelila dne 11. julija 2001.
The marketing authorisation was renewed on 11 July 2006.
Dovoljenje je bilo podaljšano 11. julija 2006.
The marketing authorisation holder is Pacira Limited
Imetnik dovoljenja za promet z zdravilom je družba Pacira Limited.
The full EPAR for DepoCyte can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo DepoCyte je na voljo tukaj.
London, 29 June 2006 Doc. Ref.
London, 29. 06. 06 Sklic dok.
EMEA/ 349192/ 2006
EMEA/ 349189/ 2006
Cytarabine has been used as an anti-cancer medicine since the 1970s.
Citarabin je v uporabi kot zdravilo proti raku že od 1970- ih dalje.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What was the recommendation of the CHMP at that time?
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšno je bilo takrat mnenje CHMP?
Therefore, at the time of the withdrawal, the CHMP’ s view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
Zato je bil v času umika vloge CHMP mnenja, da ni bilo dokazano, da so koristni učinki zdravila DepoCyte pri zdravljenju neoplastičnega meningitisa zaradi trdnega tumorja večji od z njim povezanih tveganj.
There are no consequences for DepoCyte’ s use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
Omenjeno nima posledic za uporabo zdravila DepoCyte za indikacije, za katere je bilo zdravilo že odobreno in pri katerih ostajajo koristi in tveganja nespremenjeni.
EMEA/ 349192/ 2006 0.1, CURRENT
EMEA/ 349189/ 2006 0. 1, CURRENT
Each 5 ml vial contains 50 mg cytarabine (10 mg/ ml).
Vsaka 5 mL viala vsebuje 50 mg citarabina (10 mg/ ml).
A white to off-white suspension for injection.
Bela do umazano bela suspenzija za injiciranje.
DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
DepoCyte morate uporabljati pod nadzorom zdravnikov, izkušenih v uporabi kemoterapevtikov za zdravljenje raka.
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).
Pri zdravljenju limfomatoznega meninigitisa je odmerek za odrasle 50 mg, t. j. ena viala, uporabljena intratekalno (lumbalna punkcija ali intraventrikularno skozi rezervoar Ommaya).
Induction therapy:
Začetno zdravljenje:
50 mg administered every 14 days for 2 doses (weeks 1 and 3).
2 odmerka po 50 mg vsakih 14 dni (1. in 3. teden).
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.
3 odmerki po 50 mg vsakih 14 dni (5., 7. in 9. teden), ki jim sledi dodatni odmerek po 50 mg v 13. tednu.
50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
4 odmerki po 50 mg vsakih 28 dni (17., 21., 25. in 29. teden).
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.
DepoCyte morate 1– 5 minut počasi injicirati neposredno v cerebrospinalno tekočino (CSF - cerebrospinal fluid) skozi intraventrikularni rezervoar ali neposredno v lumbalno vrečko.
Patients should be started on dexamethasone 4 mg twice daily orally or intravenously for 5 days beginning on the day of injection of DepoCyte.
Na dan injiciranja DepoCyta morajo bolniki začeti prejemati po 4- mg deksametazona peroralno ali intravensko, in sicer 5 dni dvakrat dnevno.
DepoCyte must not be administered by any other route of administration.
DepoCyte ne smete uporabljati na noben drug način.
DepoCyte must be used as supplied; do not dilute (see section 6.2).
DepoCyte morate uporabljati v obliki, v kateri je na voljo.
If it persists, treatment with DepoCyte should be discontinued.
Če nevrotoksični učinek ne preneha, morate zdravljenje z DepoCytom prekiniti.
2 Children and adolescents
2 Otroci in mladostniki
Safety and efficacy in children have not been adequately demonstrated (see section 5.1).
Varnost in učinkovitost pri otrocih še nista ustrezno ugotovljeni (glejte poglavje 5. 1).
DepoCyte is not recommended for use in children and adolescents until further data become available.
DepoCyte ni priporočeno uporabljati za zdravljenje otrok in mladostnikov dokler ni na voljo več podatkov.
Patients with active meningeal infection.
Bolniki z aktivno meningealno okužbo.
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 common adverse reaction.
Bolnike, ki prejemajo DepoCyte, morate istočasno zdraviti s kortikosteroidi (npr. z deksametazonom), da ublažite simptome arahnitisa, ki je pogosta neželena reakcija (glejte poglavje 4. 8).
The importance of concurrent dexamethasone administration should be emphasised at the initiation of each cycle of DepoCyte treatment.
Pomembnost sočasne uporabe deksametazona morate poudariti na začetku vsakega kroga zdravljenja z DepoCytom.
Cytarabine, when administered intrathecally, has been associated with nausea, vomiting and serious central nervous system toxicity including blindness, myelopathy and other neurological toxicity sometimes leading to a permanent neurological deficit.
Za intratekalno uporabo citarabina so značilni slabost, bruhanje in huda toksičnost osrednjega živčevja vključno s slepoto, mielopatijo in drugimi nevrotoksičnimi učinki, ki včasih povzročijo tudi stalni nevrološki primanjkljaj.
Administration of DepoCyte in combination with other neurotoxic chemotherapeutic agents or with cranial/ spinal irradiation may increase the risk of neurotoxicity.
Uporaba DepoCyta v kombinaciji z drugimi nevrotoksičnimi kemoterapevtiki ali z obsevanjem lobanje ali hrbtenice lahko še poveča tveganje nevrotoksičnih učinkov.
Blockage of CSF flow may result in increased free cytarabine concentrations in the CSF with increased risk of neurotoxicity.
Blokiranje pretoka cerebrospinalne tekočine lahko poveča koncentracijo prostega citarabina v njej in s tem poveča tveganje za pojav nevrotoksičnih učinkov.
Since DepoCyte’ s particles are similar in size and appearance to white blood cells, care must be taken in interpreting CSF examination following DepoCyte administration.
Delci DepoCyta so po velikosti in izgledu podobni belim krvnim celicam, zato morate biti po njegovi uporabi pri interpretiranju rezultatov pregleda cerebrospinalne tekočine previdni.
No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been established.
Skupne uporabe DepoCyta in drugih zdravil, ki delujejo na novotvorbe in so uporabljena po intratekalni poti, niso raziskovali.
3 Concomitant administration of DepoCyte with other antineoplastic agents administered by the intrathecal route has not been studied.
3 nevrotoksičnih učinkov.
Teratology studies in animals have not been conducted with DepoCyte and there are no adequate and well controlled studies in pregnant women; however cytarabine can cause foetal harm when administered during pregnancy.
Študij teratoloških učinkov DepoCyta na živalih niso opravili in tudi ni ustreznih ali dobro kontroliranih raziskav pri nosečnicah, vendar če ga uporabljajo, citarabin lahko škoduje plodu.
Therefore, women of childbearing potential should not receive the treatment until pregnancy is excluded and should be advised to use a reliable contraceptive method.
Zato morate ženskam v rodni dobi svetovati uporabo zanesljivega kontracepcijskega sredstva, in jim ne smete dajati citarabina, dokler ne izključite nosečnosti.
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.
Citarabin ima mutagene lastnosti, ki lahko povzročijo okvare kromosomov v človeških spermijih, zato morajo moški, ki se zdravijo z DepoCytom, in njihove partnerke uporabljati zanesljiva kontracepcijska sredstva.
There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines.
Ni poročil, ki bi izrecno govorila o učinkih zdravljenja z DepoCytom na sposobnost vožnje ali upravljanja s stroji.
DepoCyte has the potential of producing serious toxicity.
DepoCyte ima lahko resne toksične učinke.
All patients receiving DepoCyte should be treated concurrently with corticosteroids (e. g., dexamethasone) to mitigate the symptoms of arachnoiditis.
Vse bolnike, ki prejemajo DepoCyte, morate istočasno zdraviti s kortikosteroidi (npr. z deksametazonom), da ublažite simptome arahnitisa.
Toxic effects may be related to a single dose or to cumulative doses.
Toksični učinki se lahko nanašajo na posamezne ali na kumulativne odmerke.
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.
Lahko se pojavijo kadarkoli med zdravljenjem (čeprav najverjetneje v prvih 5 dneh uporabe), zato morate pri bolnikih, ki prejemajo DepoCyte, razvoj nevrotoksičnih učinkov nenehno nadzorovati.
If patients develop neurotoxicity, subsequent doses of DepoCyte should be reduced, and DepoCyte should be discontinued if toxicity persists.
Če pri bolnikih pride do nevrotoksičnih učinkov, morate sledeče odmerke DepoCyta zmanjšati, in če po tem ne izginejo, morate zdravljenje prekiniti.
Arachnoiditis, a syndrome manifested primarily by headache, nausea, vomiting, fever, neck rigidity, neck or back pain, meningism, convulsions, hydrocephalus, CSF pleocytosis, with or without altered state of consciousness, is a common adverse reaction.
Arahnitis, sindrom, za katerega so značilni predvsem glavobol, utrujenost, bruhanje, zvišana telesna temperatura, togost vratu, bolečine v vratu ali hrbtu, meningizem, konvulzije, hidrocefalija, pleocitoza cerebrospinalne tekočine (s spremenjenim stanjem zavesti ali brez njega), je običajen neželeni učinek.
Arachnoiditis can be fatal if left untreated.
Če arahnitisa ne zdravite, je lahko smrten.
The incidence of adverse reactions possibly reflecting meningeal irritation determined from all the patients treated with 50 mg DepoCyte in the Phase II-IV clinical trials is given in Table 1 below:
V spodnji preglednici 1 je prikazana pojavnost neželenih učinkov v celotni populaciji bolnikov, zdravljenih s 50 mg zdravila DepoCyte v kliničnih preskušanjih faz II- IV, za katere je možno, da odražajo draženje mening:
4 Table 1:
4 Preglednica 1:
Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients (n [%] of cycles* of therapy)
Neželeni učinki, za katere je možno, da odražajo draženje mening pri bolnikih v kliničnih preskušanjih faz II, III in IV (n [%] krogov * zdravljenja).
MedDRA preferred term
MedDRA priporočen izraz
DepoCyte
= 258 krogov)
Methotrexate
= 99 krogov)
Cytarabine
15% 11%
Headache NOS Nausea Vomiting NOS Arachnoiditis Pyrexia Back pain Convulsions NOS Neck pain Neck stiffness Hydrocephalus acquired CSF Pleocytosis Meningism
Arahnitis Pireksija Bolečine v hrbtu Konvulzije (brez podrobnejše opredelitve)
(n = 929 cycles) 24% 18% 17% 16% 12% 7% 6% 4% 3% 2% 1% < 1%
16% 12% 7% 6%
(n = 258 cycles) 16% 12% 11% 7% 7% 7% 5% 3% < 1% 1% 0% 1%
7% 7% 7% 5%
(n =
4% 3% 2% 1%
99 cycles) 14% 15% 11% 13% 16% 6% 2% 3% 4% 0% 0% 1%
3% 4% 0% 0%
The incidence of all adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1-4 studies in patients with lymphomatous meningitis receiving DepoCyte or cytarabine is given in Table 2 below:
1%
Table 2.
* Dolžina kroga je bila 2 tedna.
Adverse reactions occurring in > 10% of cycles in either treatment group in Phase 1- 4 study patients with lymphomatous meningitis receiving DepoCyte 50 mg or cytarabine (% of cycles* of therapy) Number of cycles
Število krogov
MedDRA Preferred Term
MedDRA priporočen izraz
(n=151 cycles)
(n=151 krogov)
(n=99 cycles)
(n=99 krogov)
Headache NOS Arachnoiditis Confusion
Glavobol (brez podrobnejše opredelitve)
Nausea Vomiting NOS Diarrhoea NOS
Diareja (brez podrobnejše opredelitve)
13% 12% 11%
11%
15% 11% 10%
10%
General Disorders and Administrative Site Conditions
Splošne težave in spremembe na mestu aplikacije
Weakness Pyrexia Fatigue
Šibkost Pireksija Utrujenost
Thrombocytopenia
Trompocitopenija
*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.
V tem času je bolnik prejel ali 1 odmerek zdravila DepoCyte ali 4 odmerke citarabina.
Cytarabine patients not completing all 4 doses within a cycle are counted as a complete cycle.
Bolniki ki niso prejeli vseh 4 odmerkov citarabina, so se šteli kot zaključen krog.
Intrathecal administration of cytarabine may cause myelopathy and other neurologic toxicity sometimes leading to a permanent neurological deficit.
Intratekalna uporaba citarabina lahko povzroči mielopatijo in druge nevrološke toksične učinke, ki včasih privedejo do trajnega nevrolološkega deficita.
Following intrathecal administration of DepoCyte, serious central nervous system toxicity, including persistent extreme somnolence, confusion, hemiplegia, visual disturbances including blindness, deafness and cranial nerve palsies have been reported.
Po intratekalni uporabi zdravila DepoCyte so poročali o hudi toksičnosti za osrednji živčni sistem, vključno s trdovratno ekstremno somnolenco, zmedenosti, hemiplegiji, motnji vida vključno s slepoto, gluhosti in paralizi kranialnih živcev.
Symptoms and signs of peripheral neuropathy, such as pain, numbness, paresthesia, hypoaesthesia, weakness, and impaired bowel and bladder control (incontinence) have also been observed.
Opazili so tudi simptome in znake periferne nevropatije, kot so bolečina, parestezija, hipoestezija, šibkost in oslabljen nadzor črevesa in mehurja (inkontinenca).
5 Adverse reactions more commonly associated with DepoCyte are headache, arachnoiditis and confusion.
Neželeni učinki, pogosteje povezani z zdravilom DepoCyte, so glavobol, arahnitis in zmedenost.
In addition, in Phase 1-4 studies, the patient incidence of convulsions was higher in the DepoCyte group (7/ 33, 21%) than in the cytarabine group (1/ 28, 4%).
Poleg tega je bila v študijah faze 1- 4 pojavnost konvulzij večja v skupini, ki je prejemala DepoCyte (7/ 33, 21%), kot v skupini, ki je prejemala citarabin (1/ 28, 4%).
Transient elevations in CSF protein and white blood cells have also been observed in patients following DepoCyte administration and also been noted after intrathecal treatment with methotrexate or cytarabine.
Po uporabi DepoCyta in intratekalnem zdravljenju z metotreksatom ali citarabinom so pri bolnikih opazili tudi prehodna povišanja beljakovin v cerebrospinalni tekočini in belih krvnih celic.
One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving DepoCyte intraventricularly.
En bolnik, ki je prejel 125 mg, je 36 ur po intraventrikularnem odmerku DepoCyta umrl zaradi encefalopatije.
There is no antidote for intrathecal DepoCyte or unencapsulated cytarabine released from DepoCyte.
Protistrup za intratekalno uporabljen DepoCyte ali neinkapsuliran citarabin, ki se sprošča iz DepoCyta, ne obstaja.
Exchange of cerebrospinal fluid with isotonic saline 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.
Ta postopek je lahko ustrezen tudi v primeru prevelikega odmerka DepoCyta.
Management of overdose should be directed at maintaining vital functions.
Zdravljenje bolnikov, ki so prejeli prevelik odmerek, mora biti usmerjeno k
Antimetabolite (pyrimidine analogue), ATC code L01B C01
Antimetabolit (analog pirimidinskih baz), Oznaka ATC L01B C01.
DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into the cerebrospinal fluid (CSF).
DepoCyte je farmacevtska oblika citarabina s podaljšanim sproščanjem, izdelana za neposredno vnašanje v cerebrospinalno tekočino (CST).
Intracellularly, cytarabine is converted into cytarabine-5’ -triphosphate (ara-CTP), which is the active metabolite.
Znotraj celic se citarabin pretvori v aktivni presnovek, citarabin- 5 ’ - trifosfat (ara- CTP).
The mechanism of action is not completely understood, but it appears that ara-CTP acts primarily through inhibition of DNA synthesis.
Načina delovanja ne razumemo v celoti, vendar kaže, da ara- CTP deluje predvsem preko zaviranja sinteze DNA.
For cell-cycle phase specific antimetabolites the duration of exposure of neoplastic cells to cytotoxic concentrations is an important determination of drug efficacy.
Za antimetabolite, specifične za fazo celičnega cikla, je trajanje izpostavljenosti neoplastičnih celic citotoksičnim koncentracijam pomemben dejavnik učinkovitosti zdravila.
In vitro studies, examining more than 60 cell lines, demonstrated that the median cytarabine concentration resulting in 50% growth inhibition (IC50) was approximately 10 μ M (2.4 μ g/ ml) for two days of exposure and 0.1 μ M (0.024 μ g/ ml) for 6 days of exposure.
In vitro študije, pri katerih so pregledali več kot 60 celičnih linij, so pokazale, da je bila srednja vrednost koncentracije citarabina, ki je povzročila 50- odstotno zaviranje rasti (IC50), po 2 dneh izpostavljanja približno 10 μM (2, 4 μg/ ml) in po 6 dneh izpostavljanja približno 0, 1 μM (0, 024 μg/ ml).
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).
V odprti, aktivno kontrolirani, multicentrični klinični študiji so 35 bolnikov z limfomatoznim meningitisom (z malignimi celicami, najdenimi pri citološkem pregledu cerebrospinalne tekočine) naključno razdelili v skupini, v katerih so intratekalno prejemali DepoCyte (n = 18) ali neinkapsulirani citarabin (n = 17).
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.
V enomesečni fazi začetnega zdravljenja so intratekalno prejemali 50 mg DepoCyta vsaka 2 tedna in 50 mg neinkapsuliranega citarabina dvakrat tedensko.
6 absence of progression of neurological symptoms) went on to receive Consolidation and Maintenance therapy for up to 29 weeks.
Bolniki, ki so se odzvali (odziv je bil opredeljen kot odstranitev malignih celic iz cerebrospinalne tekočine v odsotnosti napredovanja nevroloških simptomov), so prejemali konsolidacijsko in vzdrževalno zdravljenje največ 29 tednov.
Responses were observed in 13/ 18 (72%, 95% confidence intervals:
Odziv so opazili pri 13/ 18 (72%, 95% intervali zaupanja:
47, 90) of DepoCyte patients versus 3/ 17 (18% patients, 95% confidence intervals:
47, 90) bolnikov, ki so prejemali DepoCyte, ter pri 3/ 17 (18% bolnikov, 95% intervali zaupanja:
4, 43) in the unencapsulated cytarabine arm.
4, 43) bolnikov, ki so prejemali neinkapsulirani citarabin.
A statistically significant association between treatment and response was observed (Fisher’ s exact test p-value = 0.002).
Opazili so statistično značilno povezavo med zdravljenjem in odzivom (vrednost p pri Fischerjevem eksaktnem testu = 0, 002).
The majority of DepoCyte patients went on beyond Induction to receive additional therapy.
Večina bolnikov, ki so prejemali DepoCyte, je po začetni fazi zdravljenja dobila dodatno zdravljenje.
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).
Vsak bolnik, ki je prejemal DepoCyte, je dobil povprečno 5 krogov (obseg 1- 10 odmerkov) v povprečno 90 dneh zdravljenja (obseg od 1 do 207 dni).
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.
Srednja vrednost preživetja brez stopnjevanja bolezni (opredeljenega kot čas do stopnjevanja nevroloških simptomov ali smrti) je 77 dni pri bolnikih, ki so prejemali DepoCyte, ter 48 dni pri bolnikih, ki so prejemali neinkapsulirani citarabin (p=0, 1038).
The proportion of patients alive at 12 months was 24% for DepoCyte versus 19% for unencapsulated cytarabine.
Delež živih bolnikov po 12 mesecih je bil 24% pri DepoCytu ter 19% pri neinkapsuliranemu citarabinu.
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.
Analiza farmakokinetičnih podatkov, ki so na voljo, je pokazala, da je po intratekalnem odmerjanju DepoCyta pri obeh načinih dajanja – v lumbalno vrečko ali v intraventrikularni rezervoar – koncentracija prostega citarabina najvišja v prvih 5 urah.
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.
Tem vrhom je sledil dvofazni profil eliminacije, sestavljen iz začetnega hitrega padca, ki mu sledi počasen padec z razpolovnim časom terminalne faze od 100 do 263 ur pri odmerkih od 12, 5 mg do 75 mg.