FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast with systemically administered cytarabine which is rapidly metabolised to ara-U, conversion to ara-U in the CSF is negligible after intrathecal administration because of the significantly lower cytidine deaminase activity in the CNS tissues and CSF.
Maltese: B'kuntrast ma' cytarabine mogħti sistemikament li hu metabolizzat malajr għal ara-U, il-bidla għal ara-U fis-CSF hi negliġibbli wara l-għoti ġot-teka minħabba l-attività mnaqqsa sinifikanti ta' cytidine deaminase fit-tessuti tas-CNS u s-CSF.
English: The proportion of patients alive at 12 months was 24% for DepoCyte versus 19% for unencapsulated cytarabine.
Maltese: Il-proporzjon ta' pazjenti ħajjin wara 12-il xahar kien ta' 24% għal DepoCyte kontra 19% għal cytarabine li mhux f'kapsuli.
English: Intrathecal treatment of lymphomatous meningitis.
Maltese: Trattament ġot-teka ta' meninġite limfomatuża.
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.
Maltese: Il-parametri farmakokinetiċi ta' DepoCyte (75 mg) f'pazjenti b'meninġite neoplastika li ngħataw ilprodott mediċinali intraventrikularment jew b'titqiba fil-bażi tas-sinsla, jissuġġerixxu li l-espożizzjoni għas-sustanza attiva fl-ispazji ventrikulari jew fil-bażi tas-sinsla hi simili mingħajr ma wieħed jagħti kas minn fejn jingħata.
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.
Maltese: F'4 studji ta' Fażi I f'pazjenti b'meninġite limfomatosi li ngħataw jew DepoCyte jew cytarabine, irreazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi MedDRA u bil-frekwenza (komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 to <1/1,000); rari ħafna (<1/10,000)) f' Tabella I hawn taħt.
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).
Maltese: Reazzjonijiet avversi li possibilment jirriflettu n-newrotossiċità huma elenkati f'Tabella 2 skont issistema 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: Arachnoiditis, a very common adverse reaction associated with DepoCyte, is a syndrome manifested by several adverse reactions.
Maltese: L-araknojdite, reazzjoni avversa komuni ħafna assoċjata ma' DepoCyte, huwa sindromu b'diversi reazzjonijiet avversi.
English: DepoCyte patients received a median of 5 cycles (doses) per patient (range 1 to 10 doses) with a median time on therapy of 90 days (range 1 to 207 days).
Maltese: Pazjenti fuq DepoCyte irċivew medjan ta' 5 ċikli (dożi) kull pazjent (medda ta' 1 sa 10 dożi) bi żmien medjan fuq it-terapija ta' 90 jum (medda ta' 1 sa 207 jiem).
English: Severe neurological side effects have been reported with the use of DepoCyte.
Maltese: Effetti kollaterali newroloġiċi severi ġew irrapportati bl-użu ta' DepoCyte.
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%).
Maltese: Wara l-għoti intratekali ta' DepoCyte, tossiċità serja tas-sistema nervuża ċentrali, li tinkludi konvulżjonijiet persistenti (7%), ħedla estrema (3%), emipleġija (1%), disturbi viżwali li jinkludu għama (1%), truxija (3%), u indeboliment tal imsaren (3%) u fil-kontroll tal-bużżieqa tal-awrina (inkontinenza)(1%) ġew osservati wkoll u f'xi każijiet din il-kombinazzjoni ta' sinjali u sintomi newroloġiċi ġew irrapportati bħala s-sindromu cauda equina
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.
Maltese: (eż. dexamethasone) biex jittaffew is-sintomi ta' l-araknojdite (ara sezzjoni 4.8), li hi reazzjoni avversa komuni ħafna.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli attwalment hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwar ilpożoloġija ma tista' tingħata.
English: Patients with active meningeal infection.
Maltese: Pazjenti b'infezzjoni meninġeali attiva.
English: Тел.
Maltese: C.
English: DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into the cerebrospinal fluid (CSF).
Maltese: DepoCyte huwa formulazzjoni ta' cytarabine li terħi l-mediċina b'mod sostnut, magħmul għall-għoti dirett ġol-fluwidu ċerebrospinali (CSF).
English: • personnel must wear protective clothing: goggles, gowns, disposable gloves and masks;
Maltese: • il-personal irid jilbes ilbies protettiv: gogil, gawn, ingwanti u maskri li jintremew wara li jintużaw;
English: Very common: Thrombocytopenia Very common: Thrombocytopenia
Maltese: Komuni ħafna: Thromboċitopenija Komuni ħafna: Thromboċitopenija
English: Common: back pain, neck pain, neck stiffness Common: back pain, neck pain Uncommon: neck stiffness Common: back pain, neck pain, neck stiffness
Maltese: Komuni ħafna: dijarea, remettar, dardir Komuni ħafna: dijarea, remettar, dardir
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).
Maltese: Ir-riżultati ta' studji dwar tossiċità akuta u subakuta li saru fuq ix-xadini ssuġġerixxew li DepoCyte ġotteka kien ittolerat sa doża ta' 10 mg (komparabbli ma' doża fil-bniedem ta' 100 mg).
English: Tel: +34 91 3821870 infomed@mundipharma.es
Maltese: Mundipharma Pharmaceuticals, S.L. Tel: +34 91 3821870 infomed@mundipharma.es
English: Precautions for the handling and disposal of DepoCyte
Maltese: Mediċini oħra u DepoCyte
English: In an early uncontrolled study without dexamethasone prophylaxis, single doses up to 125 mg were administered.
Maltese: Fi studju bikri mhux ikkontrollat mingħajr profilassi ta' dexamethasone, dożi waħidhom sa 125 mg kienu mogħtija.
English: Similar changes (generally described as minimal to slight) were also observed in some animals receiving DepoFoam alone (DepoCyte vesicles without cytarabine) but not in sodium chloride solution control animals.
Maltese: Tibdiliet simili (ġeneralment deskritti bħala minimali sa ħfief) kienu osservati wkoll f'xi annimali li kienu qed jirċievu DepoFoam waħdu (bżieżaq żgħar ta' DepoCyte mingħajr cytarabine) imma mhux f'annimali tal-kontroll b'soluzzjoni ta' sodium chloride.
English: − Keep this leaflet.
Maltese: Preparazzjoni ta' DepoCyte
English: Very common: headache Common: convulsions, hydrocephalus acquired, CSF pleocytosis
Maltese: Komuni ħafna: uġigħ ta' ras Komuni: konvulżjonijiet, idroċefalu miksub, pleoċitosi fil-fluwidu ċerebro-spinali
English: There is no antidote for DepoCyte.
Maltese: M'hemmx antidot għal DepoCyte.
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.)
Maltese: Cytarabine kien klastoġeniku għal ċelluli mejotiċi; żjieda li tiddependi mid-doża, ta' anormalitajiet fl-irjus ta' l-isperma u aberrazzjonijiet talkromosomi seħħet fil-ġrieden li ngħataw cytarabine intraperitoneali (i.p.).
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.
Maltese: Żieda mhux permanenti fil-proteini fis-CSF u ċ-ċelluli bojod tad-demm ġew osservati f'pazjenti wara lgħoti ta' DepoCyte, u ġew innotati wara kura ġot-teka b'methotrexate jew cytarabine.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu/.
English: Each pack contains a single vial.
Maltese: Kull pakkett fih kunjett wieħed.
English: Cytarabine, the active ingredient in DepoCyte, can cause foetal harm when administered systemically during pregnancy, mainly during the first trimester.
Maltese: Cytarabine, is-sustanza attiva f'DepoCyte, jista' jikkaġuna ħsara lill-fetu meta jingħata b'mod sistemiku waqt it-tqala, prinċipalment fl-ewwel tlitt xhur..
English: What DepoCyte looks like and contents of the pack
Maltese: Id-Dehra ta' DepoCyte u l-kontenuti tal-pakkett
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).
Maltese: Għat-trattament ta' meninġite limfomatuża, id-doża għall-adulti hi ta' 50 mg (kunjett wieħed) mogħti minn ġot-teka (tneħħija tal-likwidu mill-bażi tas-sinsla permezz ta' labra tas-siringa jew intraventrikularment permezz tal-ħażna ta' Ommaya).
English: DepoCyte contains cytarabine, and should be disposed of in a manner consistent with local requirements.
Maltese: DepoCyte fih cytarabine, u għandu jintrema b'mod li jkun konsistenti mal-ħtiġijiet lokali.
English: България ТП Мундифарма Медикъл ООД
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: AUCs of free and encapsulated cytarabine after ventricular injection of DepoCyte appeared to increase linearly with increasing dose, indicating that the release of cytarabine from DepoCyte and the pharmacokinetics of cytarabine are linear in human CSF.
Maltese: L-AUCs ta' cytarabine ħieles u inkapsulat wara injezzjoni ventrikulari ta' DepoCyte dehru li żdiedu b'mod lineari ma' żjieda fid-doża, li jindika li l-ħruġ ta' cytarabine minn DepoCyte u l-farmakokinetiċità ta' cytarabine huma lineari fis-CSF uman.
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.
Maltese: Reviżjoni tat-tagħrif tossikoloġiku disponibbli għal-lipidi kostitwenti (DOPC u DPPG) jew fosfolipidi simili għal dawk f'DepoCyte tindika li lipidi bħal dawn huma ttollerati tajjeb fi speċi ta' annimali differenti anki meta jingħataw għall-perijodi twal ta' żmien f'dożi fil-medda ta' g/kg.
English: • Neck pain
Maltese: • Dgħjufija
English: Common (experienced in less than 1 in 10 but more than 1 in 100 patients)
Maltese: Komuni (esperjenzat minn inqas minn pazjent 1 f'10 imma aktar minn pazjent 1 f'kull 100)
English: DepoCyte is used to treat lymphomatous meningitis.
Maltese: DepoCyte jintuża għal kura tal-meninġite limfomatuża.
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).
Maltese: Minħabba li l-espożizzjoni sistemika għal cytarabine liberu wara trattament intratekali b'DopoCyte hu neġliġibbli, ir-riskju ta' fertilità indebolita mistenni jkun baxx (ara sezzjoni 5.3).
English: Infectious meningitis may be associated with intrathecal administration.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
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.
Maltese: Metodu ta' kif għandu jingħata DepoCyte għandu jingħata b'injezzjoni bil-mod fuq perjodu ta' 1-5 minuti direttament fil- fluwidu ċerebrospinali (CSF) jew permezz ta' ħażna intraventrikulari jew b'injezzjoni diretta ġor-rita tal-bażi tassinsla.
English: Vials should be allowed to warm to room temperature (18°C -22°C) for a minimum of 30 minutes and be gently inverted to resuspend the particles immediately prior to withdrawal from the vial.
Maltese: Il-kunjetti għandhom jitħallew jisħnu sat-temperatura tal-kamra (18°C - 22°C) għal mill-inqas 30 minuta u għandhom jinqalbu bil-mod biex il-partikuli jerġgħu jiffurmaw suspensjoni immedjatament qabel il-ġbid mill-kunjett.
English: In-line filters must not be used when administering DepoCyte.
Maltese: Filters in-line m'għandhomx jintużaw meta jingħata DepoCyte.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: − The other ingredients are cholesterol, triolein, dioleoylphosphatidylcholine, dipalmitoylphosphatidylglycerol, sodium chloride, and water for injections.
Maltese: − Is-sustanzi l-oħra huma cholesterol, triolein, dioleoylphosphatidylcholine,
English: • A stiff or rigid neck
Maltese: • Dardir u/jew rimettar
English: The dose for adults is 50 mg (one vial of DepoCyte).
Maltese: Id-doża għall-adulti hi ta' 50 mg (kunjett wieħed ta' DepoCyte).
English: Start-up treatment: one vial of DepoCyte (50 mg) administered every 14 days for 2 doses (weeks 1 and 3).
Maltese: Trattament tal-bidu: kunjett wieħed ta' DepoCyte (50 mg) mogħti kull 14-il jum għal 2 dożi (ġimgħa 1 u 3).
English: The transfer rate of cytarabine from CSF to plasma is slow and the conversion to uracil arabinoside (ara-U), the inactive metabolite, in the plasma is fast.
Maltese: Ir-rata ta' trasferiment ta' cytarabine mis-CSF għall-plażma hi bil-mod u l-bidla għal uracil arabinoside (ara-U), il-metabolit inattiv, fil-plażma hi mgħaġġla.
English: DepoCyte is a white to off-white-suspension for injection supplied in a glass vial.
Maltese: Suspensjoni għall-injezzjoni Suspensjoni bajda għal offwajt.
English: DepoCyte must not be mixed with any other medicinal products.
Maltese: DepoCyte m'għandux jitħallat ma' prodotti mediċinali oħra.
English: Given that cytarabine has a mutagenic potential which could induce chromosomal damage in the human spermatozoa, males undergoing DepoCyte treatment and their partner should be advised to use a reliable contraceptive method.
Maltese: Billi cytarabine għandha potenzjal mutaġeniku li jista jikkaġuna ħsara fil-kromosomi fl-isperma umana, irġiel li qed jirċievu t-trattament b'DepoCyte u s-sieħba tagħhom għandhom jingħataw il-parir biex jużaw metodu ta' kontraċezzjoni li tista' torbot fuqu.
English: The following protective recommendations are given due to the toxic nature of this substance:
Maltese: Dawn ir-rakkommandazzjonijiet protettivi li ġejjin qed jingħataw minħabba n-natura tossika ta' din issustanza:
English: Cytarabine caused the transformation of hamster embryo cells and rat H43 cells in vitro.
Maltese: Cytarabine ikkawżat it-trasformazzjoni taċ-ċelluli tal-embriju tal-ħamster u taċ-ċelluli H43 tal-firien in vitro.
English: It should not be shaken vigorously.
Maltese: U INDIRIZZ TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FISSUQ
English: Very common: arachnoiditis, confusion, headache Very common: arachnoiditis, headache Common: confusion
Maltese: Komuni ħafna: araknojdite, konfużjoni, uġigħ ta' Komuni ħafna: araknojdite, uġigħ ta' ras Komuni: konfużjoni
English: Contents of the pack and other information What DepoCyte contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih DepoCyte
English: Vigorous shaking should be avoided.
Maltese: Evita li tħallat b'mod vigoruż.
English: • Persistent or extreme sleepiness
Maltese: • Infezzjoni fil-meninġi
English: Blood and lymphatic system disorders
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: If it persists, treatment with DepoCyte should be discontinued.
Maltese: Jekk tippersisti, it-trattament b'DepoCyte għandu jitwaqqaf.
English: DepoCyte administration
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Maltese: Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
English: 0/12, 0.0% (0.0, NE)
Maltese: 0/12, 0.0% (0.0, NE) a.
English: Days 29-42
Maltese: Jiem 29-42
English: • fever (pyrexia)
Maltese: • deni (pyrexia)
English: Days 1-7
Maltese: Jiem 1-7
English: Berkshire, SL1 4DX UK
Maltese: Berkshire, SL1 4DX
English: Refractory status - n (%)
Maltese: Stat reżistenti - n (%)
English: 5 years (2°C - 8°C)
Maltese: 5 snin (2°C - 8°C)
English: 17.3 months [12.6, 23.3]
Maltese: 17.3 xhur [12.6, 23.3]
English: [4.8 to 8.3 months]
Maltese: [4.8 sa 8.3 xhur]
English: 3.8 months (1.9, 19.0)
Maltese: 3.8 xhur (1.9, 19.0)
English: Figure 2.
Maltese: Figura 2.
English: Kaplan-Meier curve of overall survival
Maltese: Kaplan-Meier tas-sopravivenza globali
English: AlloHSCT = allogeneic haematopoietic stem cell transplantation SOC = standard of care
Maltese: AlloHSCT = trapjant ta' ċelluli staminali ematopoetiċi alloġeniċi SOC = standard of care [kura standard]
English: (see section 5.1).
Maltese: (ara sezzjoni 4.2).
English: 250 mL (usual overfill volume of 265 to 275 mL)
Maltese: 250 mL (volum żejjed tas-soltu ta' 265 sa 275 mL)
English: * Based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Maltese: * Abbażi tal-Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi (CTCAE - Common Terminology Criteria for Adverse Events) tal-NCI, verżjoni 4.0.
English: ≥ 65 years old Patients in 1
Maltese: età ta' ≥ 65 sena
English: 7.5 months [4.0 to 11.8 months]
Maltese: 7.5 xhur [4.0 sa 11.8 xhur]
English: Амджен България ЕООД Тел.
Maltese: България Амджен България ЕООД
English: Body surface area, gender and age
Maltese: Erja tas-superfiċje tal-ġisem, sess u età
English: Cytokines including IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α and IFN-γ were measured and, IL-6, IL-10 and IFN-γ were most elevated.
Maltese: Iċ-ċitokini li jinkludu IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, TNF-α u IFN-γ kienu mkejla u, IL-6, IL-10 u IFN-γ kienu l-aktar elevati.
English: The active ingredient in BLINCYTO is blinatumomab.
Maltese: Is-sustanza attiva fi BLINCYTO hija blinatumomab.
English: • confusion, disorientation
Maltese: • konfużjoni, diżorjentazzjoni
English: Final interpretation of MRD results followed EuroMRD Consortium guidelines.
Maltese: L-interpretazzjoni finali ta' riżultati ta' MRD segwiet linji gwida tal-Konsorzju EuroMRD.
English: [4.2 to 7.5 months]
Maltese: [4.2 sa 7.5 xhur] 1.
English: 48 hours
Maltese: 48 siegħa
English: The primary endpoint was overall survival (OS).
Maltese: Il-punt finali primarju kien is-sopravivenza globali (OS - overall survival).
English: Insomnia
Maltese: Insomnja
English: Reconstituted BLINCYTO (number of packages)
Maltese: BLINCYTO rikostitwit (numru ta' pakketti)
English: Uncommon (≥ 1/1,000 to < 1/100)
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100)
English: Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018
Maltese: Data ta' l-aħħar tiġdid: 19 ta' April 2018
English: 4.5 months (3.6, 9.0)
Maltese: 4.5 xhur (3.6, 9.0)
English: 6.8 months [2.2 to 12.0 months]
Maltese: 6.8 xhur [2.2 sa 12.0-il xahar]
English: • Store the package at room temperature (up to 27°C).
Maltese: • Aħżen il-pakkett f'temperatura ambjentali (sa 27°C).
English: GRH0358 v1
Maltese: GRH0500MT v1
English: 10 ml
Maltese: INDIVIDWALI 10 mL
English: 11.3 months (5.2, NE) (N = 119)
Maltese: 11.3 xhur (5.2, NE) (N = 119)
English: A central laboratory subsequently confirmed MRD levels by PCR.
Maltese: Laboratorju ċentrali kkonferma sussegwentement livelli ta' MRD minn PCR.
English: • lung infection (pneumonia)
Maltese: • infezzjoni fil-pulmun (pulmonite)
English: HR (BLINCYTO/SOC Chemo) (95% CI) p-value (2-sided)
Maltese: HR (BLINCYTO/Kimoterapija SOC) (Cl ta' 95%) valur p (żewġ naħat)
English: Less than 45 kg (BSA-based dose)
Maltese: Inqas minn 45 kg (doża bbażata fuq il-BSA)
English: 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia and tachycardia.
Maltese: 7 Takikardja tinkludi takikardija tas-sinus, takikardija supraventrikulari u takikardija.
English: 3.7 months (3.0, 5.3) (N = 65)
Maltese: 3.7 xhur (3.0, 5.3) (N = 65)
English: Consistent immune-pharmacodynamic responses were observed in patients studied.
Maltese: Kienu osservati risponsi konsistenti immuni-farmakodinamiċi fil-pazjenti studjati.
English: • increased levels of liver enzymes (ALT, AST, GGT)
Maltese: • żieda fil-livell tal-enzimi tal-fwied (ALT, AST, GGT)
English: A population pharmacokinetic analysis was performed to evaluate the effects of demographic characteristics on blinatumomab pharmacokinetics.
Maltese: Twettqet analiżi farmakokinetika tal-popolazzjoni sabiex jiġu evalwati l-effetti tal-karatteristiċi demografiċi fuq il-farmakokinetika ta' blinatumomab.
English: Cytokine release syndrome (CRS)
Maltese: Sindrome ta' reħa ta' ċitokini (CRS - cytokine release syndrome)
English: Add to the sodium chloride bag only.
Maltese: Żid mal-borża ta' sodium chloride biss.
English: In this open-label study, Health related quality of life (HRQoL) reported by patients were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).
Maltese: QLQ-C30European Organisation for Research and Treatment of Cancer Quality of Life QuestionnaireCore 30).
English: • Infusion rate of 3.3 mL/h for a duration of 72 hours
Maltese: • Rata ta' infużjoni ta' 3.3 mL/siegħa għal tul ta' 72 siegħa
English: Fifty percent (5/10) compared to 0% (0/5) achieved MRD response and 20% (2/10) compared to 40% (2/5) underwent allogeneic HSCT after treatment.
Maltese: Ħamsin fil-mija (5/10) meta mqabbla ma' 0% (0/5) kisbu rispons ta' MRD u 20% (2/10) meta mqabbla ma' 40% (2/5) kellhom HSCT alloġeniku wara t-trattament.
English: There is a possibility of a higher risk of neurologic events in this population.
Maltese: Hemm possibbiltà ta' riskju ogħla ta' avvenimenti newroloġiċi f'din il-popolazzjoni.
English: Refractory to salvage therapy Maximum of central/local bone marrow blasts - n (%)
Maltese: Reżistenti għal terapija ta' salvataġġ Massimu ta' blasts tal-mudullun ċentrali/lokali - n (%)
English: SOC Chemo
Maltese: Kimoterapija SOC
English: • high blood pressure (hypertension)
Maltese: • pressjoni għolja (ipertensjoni)
English: Four patients achieved CR during consolidation cycles, resulting in a cumulative CR rate of 35.4% (67/189; 95% CI: 28.6% - 42.7%).
Maltese: Erba' pazjenti kisbu CR matul iċ-ċikli ta' konsolidazzjoni, li rriżultat f'rata kumulattiva ta' CR ta' 35.4% (67/189, CI ta' 95%: 28.6% - 42.7%).
English: At the clinical doses of 9 mcg/day and 28 mcg/day for the treatment of relapsed/refractory ALL, the mean (SD) Css was 230 (359) pg/mL and 612 (532) pg/mL, respectively.
Maltese: Fid-dożi kliniċi ta' 9 mcg/jum u ta' 28 mcg/jum għat-trattament ta' ALL li reġgħet feġġet/reżistenti, is-Css medja (SD) kienet 230 (359) pg/mL u 612 (532) pg/mL, rispettivament.
English: Forest plot of CR/CRh* rate during the first two cycles for study MT103-211 (primary analysis set)
Maltese: Forest plot tar-Rata ta' CR/CRh* matul l-ewwel żewġ ċikli għall-istudju MT103-211 (sett ta' analiżi primarja)
English: Days 8-28 Days 29-42 Days 1-28 Days 29-42
Maltese: Jiem8-28 Jiem29-42 Jiem 1-28
English: Table 9.
Maltese: Tabella 9.
English: GRH0148v2
Maltese: GRH0247MT v1
English: 3.1 months (2.6, 4.3) (N = 32)
Maltese: 3.1 xhur (2.6, 4.3) (N = 32)
English: Induction Cycle 1 Days 1-28
Maltese: Ċiklu ta' Induzzjoni 1 Jiem 1-28