FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency received a total of 64 1861 adverse drug reaction reports (ADRs) during 2004 for centrally authorised products from EU national competent authorities and marketing authorisation holders.
Maltese: matul l-2004 għal prodotti awtorizzati ċentralment minn awtoritajiet kompetenti nazzjonali ta' l-UE u detenturi ta' awtorizzazzjoni għal tqegħid fis-suq.
English: Hannes Wahlroos (Alternate: Pekka JÄRVINEN)
Maltese: Hannes Wahlroos (Sostitut:
English: Protelos !
Maltese: Finalizzati
English: Evaluation time for type-II variations (30-day procedure)
Maltese: Zmien tal-valutazzjoni g?al varjazzjonijiet tat-tip-II (pro?edura ta' 30 jum)
English: This report covers activities of the EMEA in 2004.
Maltese: Dan ir-rapport ikopri l-attivitajiet ta' l-EMEA fl-2004.
English: Adopted in October 2004
Maltese: Adottata f'April 2004
English: Statistical information on applications under the mutual recognition procedure is provided by the EMEA and presented in the monthly MRFG press releases.
Maltese: Informazzjoni statistika dwar applikazzjonijiet taħt ilproċedura ta' rikonoxximent reċiproku hija provduta mill-EMEA u ppreżentata fl-istqarrijiet għallistampa ta' kull xahar ta' l-MRFG.
English: In 2004, the number of pre-submission meetings held was 65.
Maltese: Fl-2004, l-għadd ta' laqgħat ta' qabel issottomissjoni li saru kien ta' 65.
English: Sabine BROSCH
Maltese: Jiří BUREŠ
English: Annex 8 IT projects and operational activities
Maltese: Anness 8 Proġetti ta' l-IT u attivitajiet operattivi
English: rasagiline !
Maltese: Taħriġ
English: Type-IB variations
Maltese: Imsieħba Internazzjonali
English: Fee income
Maltese: Alar IRS
English: Initiatives undertaken in 2004 mainly related to the areas of risk identification and risk evaluation: in the field of risk identification through the further development and implementation of EudraVigilance; in the area of risk assessment by looking at a more proactive conduct of pharmacovigilance.
Maltese: L-inizjattivi li ttieħdu fl-2004 kienu relatati l-aktar ma' l-oqsma ta' l-identifikazzjoni tar-risku u lvalutazzjoni tar-riskju: fil-qasam ta' l-identifikazzjoni tar-riskju permezz ta' l-iżvilupp u limplimentazzjoni ulterjuri tal-EudraVigilance; fil-qasam tal-valutazzjoni ta' riskju billi tiġi eżaminata l-possibiltà ta' tmexxija aktar proattiva tal-farmakoviġilanza.
English: strontium ranelate !
Maltese: Protelos strontium ranelate Part B
English: See section 4..
Maltese: Ara sezzjoni 4.
English: − The active substance is cytarabine.
Maltese: − Is-sustanza attiva hi cytarabine.
English: Cytarabine (n = 99 cycles)
Maltese: Cytarabine (n = 99 ċiklu)
English: • Partial paralysis
Maltese: • Paraliżi parzjali
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriku u tat-tessuti konnettivi
English: Table 3: Adverse reactions possibly reflecting meningeal irritation in Phase II, III, and IV patients
Maltese: Table 3: Reazzjonijiet avversi li possibilment jirriflettu irritazzjoni meninġeali f'pazjenti f'Fażi II, III, u IV
English: DepoCyte (n = 929 cycles) Methotrexate (n = 258 cycles) Cytarabine (n = 99 cycles)
Maltese: DepoCyte (n = 929 ċiklu) Methotrexate (n = 258 ċiklu) Cytarabine (n = 99 ċiklu)
English: DepoCyte (n = 929 cycles)
Maltese: DepoCyte (n = 929 ċiklu)
English: DepoCyte has the potential of producing serious neurological toxicity.
Maltese: DepoCyte għandu l-potenzjal li jipproduċi tossiċità newroloġika serja.
English: Common: urinary incontinence Common: urinary incontinence
Maltese: Komuni: inkontinenza tal-awrina Komuni: inkontinenza tal-awrina
English: Methotrexate (n = 258 cycles)
Maltese: Methotrexate (n = 258 ċiklu)
English: Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections
Maltese: Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride
English: DepoCyte should be injected slowly over a period of 1-5 minutes.
Maltese: DepoCyte għandu jkun injettat bil-mod matul perijodu ta' 1-5 minuti.
English: For the full list of excipients, see section 6.1.
Maltese: Għallista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Patients who did not respond discontinued protocol treatment after 4 weeks.
Maltese: Pazjenti li ma rrispondewx waqqfu t-trattament talprotokoll wara 4 ġimgħat.
English: • Confusion
Maltese: • Konfużjoni
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.
Maltese: Dawn l-ogħla ammonti kienu segwiti minn profil ta' eliminazzjoni bifażika li tikkonsisti fi tnaqqis qawwi inizjali u tnaqqis sussegwenti bil-mod b'half-life tal-fażi terminali ta' 100 sa 263 siegħa fuq medda ta' doża ta' 12.5 mg sa 75 mg.
English: Nervous system disorders
Maltese: Disturbi fis-Sistema Nervuża
English: Each vial contains 50 mg cytarabine (10 mg/ml).
Maltese: Kull kunjett fih 50 mg ta' cytarabine (10 mg/ml).
English: Mundipharma Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
Maltese: Gesellschaft m.b.H., Austria Tel: +40 751 121 222 office@mundipharma.ro
English: • a designated area should be defined for preparation (preferably under a laminar flow system).
Maltese: • żona speċifika għandha tkun definita għall-preparazzjoni (preferibbilment taħt sistema ta' tnixxija laminari).
English: DepoCyte 50 mg suspension for injection Cytarabine
Maltese: DepoCyte 50 mg suspensjoni għall-injezzjoni Cytarabine
English: More than 90% of cytarabine was excreted by day 4 and an additional 2.7% by 21 days.
Maltese: Iktar minn 90% ta' cytarabine tneħħa mil-ġisem sar-4 jum u 2.7% addizzjonali sal-21 jum.
English: Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, United Kingdom.
Maltese: Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, ir-Renju Unit
English: Intracellularly, cytarabine is converted into cytarabine-5'-triphosphate (ara-CTP), which is the active metabolite.
Maltese: Fiċ-ċelluli, cytarabine tinbidel f'cytarabine-5'-triphosphate (araCTP), li huwa l-metabolit attiv.
English: Ηνωμένο Βασίλειο
Maltese: U MNEJN GĦANDU JINGĦATA
English: DepoCyte 50 mg suspension for injection
Maltese: DepoCyte 50 mg suspensjoni għall-injezzjoni
English: DepoCyte is a sterile white to off-white-suspension.
Maltese: DepoCyte huwa suspensjoni sterili bajda għal offwajt.
English: Common: cauda equina syndrome, convulsions, cranial nerve palsies, hypoesthesia, myelopathy, paresthesia, hemiplegia, numbness
Maltese: Komuni: sindromu ta' cauda equina, konvulżjonijiet, puplesija tan-nerv kranjali, ipoestesija, majelopatija, parestesija, hemipleġja, tirżiħ
English: Suspension for injection.
Maltese: Suspensjoni għall-injezzjoni.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Convulsion
Maltese: • Konvulżjoni
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%).
Maltese: F'4 studji ta' Fażi 1 l-aktar reazzjonijiet avversi komuni rrapportati assoċjati ma' DepoCyte kienu l-uġigħ ta' ras, (23%) araknojdite (16%), deni (14%), dgħufija (13%), dardir (13%), remettar (12%), konfużjoni (11%), tromboċitopenija (10%) u għeja (6%).
English: One patient at the 125 mg dose level died of encephalopathy 36 hours after receiving DepoCyte intraventricularly.
Maltese: Pazjent wieħed fil-livell tad-doża ta' 125 mg miet bl-enċefalopatija 36 siegħa wara li rċieva DepoCyte intraventrikularment.
English: One ml of suspension contains 10 mg cytarabine.
Maltese: Millilitru wieħed ta' suspensjoni fih 10 mg cytarabine.
English: +359 2 962 13 56/54 mundipharma@mundipharma.bg
Maltese: ТП Мундифарма Медикъл ООД Тел. +359 2 962 13 56/54 mundipharma@mundipharma.bg
English: White to off-white suspension.
Maltese: M'għandekx tiddilwi s-suspensjoni.
English: Medis Adria d.o.o.
Maltese: Medis Adria d.o.o. Kolarova 7, 10000
English: Tél/Tel: +32 (0) 15 45 11 80 info@mundipharma.be
Maltese: Tél: +32 (0) 15 45 11 80 info@mundipharma.be
English: Date of first authorisation: 11 July 2001 Date of latest renewal: 11 July 2011
Maltese: Data tal-aħħar tiġdid: 11 ta' Lulju, 2011
English: PC: {number} SN: {number} NN: {number}
Maltese: X'għandek tkun taf qabel ma tingħata DepoCyte
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)
Maltese: Tabella 2: Reazzjonijiet avversi li possibilment jirriflettu n-newrotossiċita` f'pazjenti li jkunu f'Fażi II, III, u IV li qed jirċievu DepoCyte 50 mg (n = 99 ċiklu) jew cytarabine ( n = 84 ċiklu)
English: Before DepoCyte is used the vial should be warmed to room temperature (18°C - 22°C) for at least 30 minutes.
Maltese: Qabel ma tuża DepoCyte, saħħan il-kunjett sakemm jilħaq temperatura ambjentali (18°C - 22°C) għal ta' lanqas 30 minuta.
English: Common: impaired bowel control
Maltese: Common: nuqqas ta' kontroll tal-musrana
English: Intrathecal use.
Maltese: Mhux applikabbli.
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).
Maltese: Lingredjent attiv, cytarabine, kien mutaġeniku f'testijiet in vitro u kien klastoġeniku in vitro (aberrazzjonijiet tal-kromosomi u skambju tal-kromatid-oħt f'lewkoċiti umani) u in vivo (aberrazzjonijiet tal-kromosomi u assay ta' l-iskambju tal-kromatid-oħt fil-mudullun ta' annimali gerriema, assay mikronuklejari tal-ġrieden).
English: One 5 ml vial.
Maltese: Kunjett wieħed ta' 5 ml.
English: <2D barcode carrying the unique identifier included.>
Maltese: <barcode 2D li jkollu l-identifikatur uniku inkluż.> <Mhux applikabbli.>
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).
Maltese: Fi studju kliniku open label, ikkontrollat attivatament, u multiċentriku, 35 pazjent b'meninġite limfomatuża (b'ċelluli malinni misjuba fiċ-ċitoloġija tas-CSF) kienu magħżula bl-addoċċ għat-terapija ġot-teka b'DepoCyte (n=18) jew b'cytarabine li mhux f'kapsuli (n=17).
English: Tel : +420 222 318 221 office@mundipharma.cz
Maltese: Austria Organizační složka ČR Tel : +420 222 318 221 office@mundipharma.cz
English: Pharmacotherapeutic group: Antimetabolites, pyrimidine analogues, ATC code: L01BC01
Maltese: Antimetaboliti, analogi tal-pyrimidine, Kodiċi ATC:
English: Maintenance therapy: 50 mg administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Maltese: Terapija ta' manteniment: 50 mg mogħtija kull 28 jum għal 4 dożi (ġimgħat 17, 21, 25 u 29).
English: Read the package leaflet before use.
Maltese: Issuqx matul it-trattament.
English: Systemic exposure to cytarabine was determined to be negligible following intrathecal administration of 50 mg and 75 mg of DepoCyte.
Maltese: Kien iddeterminat li l-espożizzjoni sistemika għal cytarabine hi negliġibbli wara l-għoti ġot-teka ta' 50 mg u 75 mg ta' DepoCyte.
English: DepoCyte must not be mixed with any other medicinal products (see section 6.2).
Maltese: Tħallatx DepoCyte ma' xi prodotti mediċinali oħra (ara sezzjoni 6.2).
English: Also contains: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, water for injections.
Maltese: Fih ukoll: cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, ilma għall-injezzjonijiet.
English: In vitro studies, examining more than 60 cell lines, demonstrated that the median cytarabine concentration resulting in 50% growth inhibition (IC50) was approximately 10 µM (2.4 µg/ml) for two days of exposure and 0.1 µM (0.024 µg/ml) for 6 days of exposure.
Maltese: Studji in vitro, li eżaminaw aktar minn 60 razza ta' ċelluli, urew li l-medjan tal-konċentrazzjoni ta' cytarabine li irriżulta f'inibizzjoni tat-tkabbir ta' 50% (IC50) kien ta' madwar 10 µM (2.4 µg/ml) għal jumejn ta' espożizzjoni, u ta' 0.1 µM (0.024 µg/ml) għal 6 ijiem ta' espożizzjoni.
English: Encapsulated cytarabine concentrations and the counts of the lipid particles in which the cytarabine is encapsulated in followed a similar distribution pattern.
Maltese: Konċentrazzjonijiet ta' cytarabine inkapsulat u l-għadd tal-partikuli tal-lipidi li fihom cytarabine hu inkapsulat, segwew mod ta' distribuzzjoni simili.
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.
Maltese: B'kuntrast, l-għoti ġot-teka ta' 30 mg ta' cytarabine ħieles wera profil ta' konċentrazzjoni bifażiku tas-CSF b'half-life tal-fażi terminali ta' madwar 3.4 sigħat.
English: If left untreated, chemical arachnoiditis may be fatal.
Maltese: Jekk ma tiġix ittrattata, l-araknojdite kimika tista' tkun fatali.
English: No statistically significant differences were noted in secondary endpoints such as duration of response, progression-free survival, neurological signs and symptoms, Karnofsky performance status, quality of life and overall survival.
Maltese: L-ebda differenzi statistikament sinifikanti ma kienu nnutati f'endpoints sekondarji bħat-tul tar- respons, is-sopravivenza mingħajr progressjoni, is-sinjali u sintomi newroloġiċi, l-istat tal-prestazzjoni ta' Karnofsky, il-kwalità tal-ħajja u sopravivenza totali.
English: - o.z Tel: +421 2 63811611 mundipharma@mundipharma.sk
Maltese: Mundipharma Ges.m.b.H. - o.z Tel: +421 2 63811611 mundipharma@mundipharma.sk
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)
Maltese: Reazzjonijiet avversi li jseħħu f'aktar minn > 10% ta' ċikli f'xi wieħed mill-gruppi ta' trattament f'pazjenti f'4 studji ta' fażi 1 b'meninġite limfomatosi li qed jingħataw DepoCyte 50 mg (n = 151 ċiklu) jew cytarabine (n = 99 ċiklu)
English: Anaphylactic reactions following intravenous administration of free cytarabine have been rarely reported.
Maltese: Reazzjonijiet anafilattiċi wara l-għoti minn ġol-vina ta' cytarabine libera rarament kienu rrappurtati.
English: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom.
Maltese: Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, ir-Renju Unit.
English: Common: visual disturbances, blindness Common: visual disturbances, blindness
Maltese: Komuni: disturbi viżwali, għama Komuni: disturbi viżwali, għama
English: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP United Kingdom
Maltese: Pacira Limited Wessex House Marlow Road Bourne End Buckinghamshire SL8 5SP
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.
Maltese: Terapija ta' konsolidazzjoni: 50 mg mogħtija kull 14-il jum għal 3 dożi (ġimgħat 5, 7 u 9) segwiti minn doża addizzjonali ta' 50 mg f'ġimgħa 13.
English: Median progression-free survival (defined as time to neurological progression or death) for all treated patients was 77 versus 48 days for DepoCyte versus unencapsulated cytarabine, respectively.
Maltese: Il-medjan tas-sopravivenza mingħajr progressjoni (definit bħala ż-żmien għall-progressjoni newroloġika jew il-mewt) għall-pazjenti kollha ttrattati kien ta' 77 kontra 48 jum għal DepoCyte kontra cytarabine li mhux f'kapsuli, rispettivament.
English: KBM Pharma OÜ Tel. +372 733 8080 kbmpharma@kbmpharma.eu
Maltese: +372 733 8080 kbmpharma@kbmpharma.eu
English: • Shaking
Maltese: • Sturdament
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.
Maltese: Ir-rotta primarja ta' l-eliminazzjoni ta' cytarabine hi l-metaboliżmu għall-kompost inattiv ara-U, (1-β- Darabinofuranosyluracil jew uracil arabinoside) segwit minn eskrezzjoni fl-awrina ta' ara-U.
English: Tel: +48(0) 22 866 87 12 office@mundipharma.pl
Maltese: Mundipharma Polska Sp.z o.o. Tel: +48(0) 22 866 87 12 office@mundipharma.pl
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.
Maltese: Cytarabine, meta mogħti minn ġot-teka, kien assoċjat ma' dardir, rimettar, u tossiċità serja tas-sistema nervuża ċentrali li tista' twassal għal defiċjenzi permanenti, li jinkludu għama, mijelopatija u tossiċità newroloġika.
English: Responses were observed in 13/18 (72%, 95% confidence intervals: 47, 90) of DepoCyte patients versus 3/17 (18% patients, 95% confidence intervals: 4, 43) in the unencapsulated cytarabine arm. A statistically significant association between treatment and response was observed (Fisher's exact test p-value = 0.002).
Maltese: 47, 90) ta' pazjenti fuq DepoCyte kontra 3/17 (18% tal-pazjenti, 95% intervalli ta' kunfidenza:
English: The CSF clearance rate of cytarabine is similar to the CSF bulk flow rate of 0.24 ml/min.
Maltese: Ir-rata ta' tneħħija tas-CSF ta' cytarabine hi simili għar-rata tat-tnixxija totali tas-CSF ta' 0.24 ml/min.
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.
Maltese: Id-distribuzzjoni u t-tneħħija ta' cytarabine u tal-komponent fosfolipidu predominanti tal-partikula tallipidu (DOPC) wara l-għoti ġot-teka ta' DepoCyte kien evalwat f'annimali gerriema.
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2oC - 8oC).
English: Package leaflet: Information for the user DepoCyte 50 mg suspension for injection
Maltese: Informazzjoni għall-utent DepoCyte 50 mg suspensjoni għall-injezzjoni
English: Wessex House, Marlow Road Bourne End, Buckinghamshire SL8 5SP
Maltese: Wessex House, Marlow Road Bourne End, Buckinghamshire SL8 5SP Ηνωμένο Βασίλειο
English: Mundipharma AB Tel: + 46 (0)31 773 75 30 info@mundipharma.se
Maltese: Tel: + 46 (0)31 773 75 30 info@mundipharma.se
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%).
Maltese: L-inċidenza ta' dawn ir-reazzjonijiet avversi, li possibilment jirriflettu irritazzjoni meninġeali, jinkludu uġigħ ta' ras (24%), dardir (18%), rimettar (17%), deni (12%), ebusija tal-għonq (3%), uġigħ tal-għonq (4%), uġigħ tad-dahar (7%), meninġiżmu (<1%),
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.
Maltese: Kunjett tal-ħġieġ ta' Tip I magħluq b'tapp tal-gomma butyl b'wiċċ ta' fluororesin issiġillat b'siġill li jinqala' tal-aluminju li fih 50 mg cytarabine f'suspensjoni ta' 5 ml.
English: Patients who achieved a response (defined as clearing of the CSF of malignant cells in the absence of progression of neurological symptoms) went on to receive Consolidation and Maintenance therapy for up to 29 weeks.
Maltese: Pazjenti li rnexxielhom jirrispondu (ir-respons kien definit bħala l-ikklirjar tas-CSF ta' ċelluli malinni fin-nuqqas ta' progressjoni ta' sintomi newroloġiċi) komplew it-trattament u rċivew it-Terapija ta' Konsolidazzjoni u ta' Manteniment sa 29 ġimgħa.
English: Maintenance treatment: one vial of DepoCyte (50 mg) administered every 28 days for 4 doses (weeks 17, 21, 25 and 29).
Maltese: Trattament ta' manteniment: kunjett wieħed ta' DepoCyte (50 mg) mogħti kull 28 jum għal 4 dożi (ġimgħat 17, 21, 25 u 29).
English: Hydrocephalus has also been reported, possibly precipitated by arachnoiditis.
Maltese: L-idroċefalu kien irrappurtat ukoll, possibbilment ikkawżat mill-araknojdite.
English: Systemic toxicity due to intravenous administration of cytarabine consists primarily of bone marrow suppression with leucopenia, thrombocytopenia and anaemia.
Maltese: Tossiċità sistemika minħabba l-għoti minn ġol-vina ta' cytarabine tikkonsisti primarjament mit-trażżin tal-mudullun bil-lewkopenja, tromboċitopenja u anemija.
English: Common: deafness Common: deafness
Maltese: Komuni: ħedla Komuni: ħedla
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).
Maltese: Il-frekwenza ta' effetti sekondarji possibbli hija mfissra permezz tal-konvenzjoni li ġejja: komuni ħafna (taffettwa aktar minn utent 1 f'10); komuni (taffettwa minn 1 sa 10 utenti f'100); mhux komuni (taffettwa minn 1 sa 10 utenti f'1,000); rari (taffettwa 1 sa 10 utenti f'10,000); rari ħafna (taffettwa inqas minn utent 1 f'10,000); mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli).
English: Mundipharma Oy Puh/Tel: +358 (0)9 8520 2065 info@mundipharma.fi
Maltese: +358 (0)9 8520 2065 info@mundipharma.fi
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).
Maltese: Reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi MedDRA u l-frekwenza: komuni ħafna ( ≥1/10); komuni (≥1/100 sa < 1/10); u mhux komuni (≥ 1/1,000 to < 1/100).
English: Symptoms have included effects on the nervous system (e.g. convulsions, pain, numbness or tingling, blindness or visual disturbances).
Maltese: Is-sintomi kienu jinkludu effetti fuq is-sistema nervuża (e.g. konvulżjonijiet, uġigħ, tirżiħ jew tnemnim, agħma jew disturbi viżwali).
English: Proper precautions should be taken for the handling and administration of a cytotoxic drug (proper handling technique, use of a suitable designated area, protective clothing, procedures to address risk of contamination).
Maltese: Prekawzjonijiet adattati għandhom jittieħdu fl-immaniġġjar u l-għoti ta' mediċina ċitotossika (teknika ta' manipulazzjoni adattata, użu fil-post xieraq adattat, ilbies protettiv, proċeduri li jindirizzaw ir- riskju ta' kontaminazzjoni).
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.
Maltese: Fi studju eskalat open-label dwar doża mhux komparattiv fuq 18-il pazjent pedjatriku (bejn 4 sa 19-il sena) li kellhom il-meninġite lewkemika jew meninġite neoplastika minħabba tumur primarju fil- moħħ, doża ġot-teka ta' 35 mg kinet identifikata bħala d-doża massima ttolerata.