FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean half-life after absorption from the injection site was 1.7 days and the elimination half-life was 5.5 days.
Maltese: Il-half-life medja wara l-assorbiment mis-sit tal-injezzjoni kienet 1.7 jiem u l-half-life taleliminazzjoni kienet 5.5 jiem.
English: - if you get a fever.
Maltese: - Palpitazzjonijiet;
English: A temporary suppression in body weight gains and a temporary reduction in total leukocyte counts were observed in dogs which were treated with pegaspargase 1200 U/kg weekly for 2 weeks.
Maltese: Soppressjoni temporanja fiż-żidiet tal-piż tal-ġisem u tnaqqis temporanju fl-għadd totali tal-lewkoċiti ġew osservati fil-klieb li kienu kkurati b'doża ta' 1,200 U/kg ta' pegaspargase kull ġimgħa għal ġimagħtejn.
English: Depletion of L-asparagine in blood results in inhibition of protein-synthesis, DNA-synthesis and RNA-synthesis, especially in leukaemic blasts which are not able to synthesise L-asparagine, thus undergoing apoptosis.
Maltese: In-nuqqas ta' L-asparagine fid-demm jirriżulta fl-inibizzjoni tas-sintesi tal proteini, sintesi tad-DNA u sintesi tal-RNA, speċjalment fi blasts tal-lewkimja li ma jkunux kapaċi jissintetizzaw L-asparagine, u b'hekk jgħaddu minn apoptożi.
English: During Induction (N=47; Study AALL07P4) PK Parameters
Maltese: DFCI 11-001 u AALL07P4).
English: History of serious thrombosis with prior L-asparaginase therapy.
Maltese: - jekk xi darba kellek emboli tad-demm wara terapija b'asparaginase.
English: A rise in serum urea occurs regularly, is dose-independent and nearly always a sign of pre-renal metabolic imbalance.
Maltese: Żieda tal-urea fis-serum isseħħ regolarment, hi indipendenti mid-doża u kważi dejjem tkun sinjal li jindika żbilanċ metaboliku prerenali.
English: Hepatobiliary disorders
Maltese: Pankreatite psewdoċista, parotite*
English: Consolidation phases.
Maltese: Unità.
English: Since the proteolytic enzymes responsible for Oncaspar metabolism are ubiquitously distributed in tissues the exact role of the liver is unknown: however any decrease in liver function is not expected to present clinical relevant problems in the use of Oncaspar.
Maltese: Billi l-enzimi proteolitiċi responsabbli għall-metaboliżmu ta' Oncaspar huma mqassma b'mod uniformi fit-tessuti, ir-rwol preċiż tal-fwied mhuwiex magħruf: madankollu, kwalunkwe tnaqqis filfunzjoni tal-fwied mhux mistenni li jikkawża problemi rilevanti kliniċi fl-użu ta' Oncaspar.
English: international normalised ratio increased, hypokalaemia, blood cholesterol increased, hypofibrinogenaemia, gamma-glutamyl transferase increased Not known: Blood urea increased, anti-pegaspargase antibodies, neutrophil count decreased, platelet count decreased, hyperammonaemia
Maltese: Żieda tal-urea fid-demm, antikorpi anti-pegaspargase, tnaqqis fl-għadd tan-newtrofili, tnaqqis fl-għadd tal-plejtlits, iperammonemija
English: Common: Seizure, peripheral motor neuropathy, syncope Rare: Posterior reversible leukoencephalopathy syndrome Not known: Somnolence, tremor*
Maltese: Komuni: Aċċessjoni, newropatija tal-Moviment Periferali, sinkope Rari:
English: NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml solution for injection/infusion pegaspargase
Maltese: Informazzjoni għall-utent Oncaspar 750 U/ml soluzzjoni għall-injezzjoni/infużjoni pegaspargase
English: Figure 1: Mean (± standard error) serum asparagine during Study CCG-1962 induction phase
Maltese: Figura 1: Il-medja (± (żball standard) ta' asparagine fis-serum matul il-fażi ta' induzzjoni ta'
English: Caution is therefore needed when anticoagulants such as coumarin, heparin, dipyridamole, acetylsalicylic acid or non-steroidal anti-inflammatory medicinal products are given concomitantly, or when concomitant chemotherapy regimen including methotrexate, daunorubicin, corticosteroids is administered.
Maltese: Għalhekk, il-kawtela hi meħtieġa meta antikoagulanti bħal coumarin, eparina, dipyridamole, acetylsalicylic acid jew prodotti mediċinali antiinfjammatorji mhux sterojdi jingħataw fl-istess ħin, jew meta jingħata kors ta' kimoterapija fl-istess ħin li jinkludi methotrexate, daunorubicin, u kortikosterojdi.
English: The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml (0.9%) solution or 5% glucose.
Maltese: Is-soluzzjoni dilwita tista' tingħata fuq perjodu ta' minn siegħa sa sagħtejn flimkien ma' infużjoni li tkun diġà għaddejja ta' jew sodium chloride 9 mg/ml (0.9%) jew 5% glucose.
English: Skin and subcutaneous tissue disorders
Maltese: Nekrolisi epidermali tossika*
English: ALL patients with several relapses were treated either with Oncaspar or with native asparaginase from E. coli as part of an induction therapy.
Maltese: Il-pazjenti b'ALL b'diversi episodji ta' rikaduti ġew ikkurati jew b'Oncaspar jew b'native asparaginase minn E. coli bħala parti minn terapija ta' induzzjoni.
English: These results indicate that, when Oncaspar 2,500 U/m2 BSA is administered as single and repeated doses every two weeks, clinically relevant asparaginase activity is sustained over the entire dosing interval (i.e., two weeks).
Maltese: Dawn ir-riżultati jindikaw li, meta Oncaspar 2,500 U/m2 BSA jingħata bħala doża waħda u ripetuta kull ġimagħtejn, attività ta' asparaginase klinikament rilevanti tkun sostnuta matul l-intervall tad-dożaġġ sħiħ (jiġifieri, ġimagħtejn).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous or intramuscular use.
Maltese: U/kg), permezz tar-rotta ġol-vini.
English: Very common (may affect more than 1 in 10 people) - Changes in the function of the pancreas; - Weight loss; - Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism); - Loss of appetite, general weakness, vomiting, diarrhoea, nausea; - Increased blood sugar levels.
Maltese: - Uġigħ fir-riġel (li jista' jkun simbolu ta' trombożi), uġigħ fis-sider jew qtugħ ta' nifs (li jista' jkun sintomu ta' emboli tad-demm fil-pulmun, imsejjaħ emboliżmu pulmonari);
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien u l-kundizzjonijiet tal-ħażna waqt l-użu u ta' qabel l-użu huma r-responsabbiltà tal-utent, u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C-8°C, ħlief jekk irrikostituzzjoni/dilwizzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with other chemotherapy products known to interact with CYP enzymes.
Maltese: Pegaspargase jista' jinterferixxi mal-metaboliżu u t-tneħħija ta' prodotti mediċinali oħrajn, abbażi tal effetti tiegħu fuq is-sintesi tal-proteini u l-funzjoni tal-fwied, kif ukoll mill-użu kombinat tiegħu ma'
English: Uric acid nephropathy may develop.
Maltese: Tista' tiżviluppa nefropatija minħabba uric acid.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3,750 U
Maltese: INDIVIDWALI 3,750 U
English: A population pharmacokinetic evaluation of Oncaspar based on data obtained from Studies AALL07P4 (IV), DFCI 11-001 (IV), and CCG-1962 (IM) identified that clearance (linear and saturable) increased approximately proportional to BSA and volume of distribution increased slightly more proportional to BSA.
Maltese: Abbażi tar-riżultati minn dawn iż-żewġ studji, ingħatat doża BSA ta' 2,500 U/m2 ta' Oncaspar ġol muskoli (CCG-1962) u ġol-vini (AALL07P4) li tipprovdi manteniment tat-tnaqqis ta' L-asparagine għal madwar ġimagħtejn wara d-dożaġġ.
English: Post-authorisation efficacy study (PAES): In order to further define the efficacy and safety of Oncaspar in patients with newly diagnosed acute lymphoblastic leukaemia, the MAH should submit the results of Study CAALL-F01, a prospective multicentre cohort study evaluating Oncaspar used in the first-line treatment of children and adolescents with ALL along with multi-agent chemotherapy.
Maltese: Sabiex jiddefinixxi aktar leffikaċja u s-sigurtà ta' Oncaspar f'pazjenti b'lewkimja limfoblastika akuta li tkun ġiet iddjanjostikata għall-ewwel darba, l-MAH għandu jissottometti r-riżultati ta' Studju CAALL-F01, studju dwar koorti, multiċentriku u prospettiv, li evalwa
English: Procedures for proper handling of antineoplastic agents should be observed.
Maltese: M'hemmx dejta disponibbli għal pazjenti anzjani.
English: Mild hepatotoxicity was observed with the same dosages.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ.
English: Fatty liver can be observed very frequently.
Maltese: Fwied xaħmi jista' jiġi osservat b'mod frekwenti ħafna.
English: There are limited data on the use of L-asparaginase and no data on the use of Oncaspar in pregnant women.
Maltese: Hemm dejta limitata fuq l-użu ta' L-asparaginase u l-ebda data fuq l-użu ta' Oncaspar f'nisa tqal.
English: Days After First Dose of L-Asparaginase
Maltese: Jiem Wara l-Ewwel Doża tal-L-Asparaginase
English: An indirect interaction cannot be ruled out between pegaspargase and oral contraceptives due to pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives.
Maltese: Interazzjoni indiretta ma tistax tiġi eskluża bejn pegaspargase u kontraċettivi orali minħabba lepatotossiċità ta' pegaspargase li tista' tfixkel it-tneħħija tal-kontraċettivi orali mill-fwied.
English: 14 October 2016 EMA/656265/2016 EMEA/H/C/004003
Maltese: 14 ta' Ottubru 2016 EMA/656265/2016 EMEA/H/C/004003
English: What is Zemfirza?
Maltese: X'inhu Zemfirza?
English: The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors.
Maltese: Is-sustanza attiva f'Zemfirza, iċ-ċediranib, timblokka l-attività tar-riċetturi "tal-fattur tal-iżvilupp talendotilju vaskulari" (VEGF, vascular endothelial growth factor).
English: Zemfirza is a cancer medicine that contains the active substance cediranib.
Maltese: Zemfirza huwa mediċina kontra l-kanċer li fiha s-sustanza attiva ċediranib.
English: Zemfirza was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer.
Maltese: Zemfirza ġie kklassifikat bħala 'mediċina orfni' (mediċina li għandha tintuża f'mard rari) fid29 ta' Lulju 2014 għall-kura ta' kanċer tal-ovarji.
English: What was Zemfirza expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Zemfirza?
English: Withdrawal of the marketing authorisation application for Zemfirza (cediranib)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Zemfirza (cediranib)
English: On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer.
Maltese: Fid-19 ta' Settembru 2016, AstraZeneca AB għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Zemfirza, għall-kura tal-kanċer tal-ovarji.
English: Further information on the orphan designation can be found here.
Maltese: Unknown document property name.
English: The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju wieħed ewlieni li involva 456 pazjent bil-kanċer tal-ovarji li reġa' tfaċċa wara 6 xhur jew aktar, wara kura waħda preċedenti b'mediċina bbażata fuq il-platinu.
English: Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen).
Maltese: Zemfirza kien mistenni li jintuża sabiex jikkura n-nisa b'kanċer tal-ovarji, inkluż kanċer tat-tubi fallopjani li jaqbdu mal-ovarji fil-ġuf u l-kanċer tal-peritoneum (ir-rita tal-membrana tal-addome).
English: In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.
Maltese: Barra minn hekk, it-titjib osservat fis-sopravivenza mingħajr progressjoni b'Zemfirza kien meqjus żgħir u kien hemm tħassib rigward l-effetti sekondarji tal-mediċina, b'mod partikolari ddijarea u l-għeja, li wasslu għal ħafna pazjenti jwaqqfu l-kura kmieni.
English: The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP).
Maltese: Is-CHMP kien imħasseb dwar l-affidabilità tar-riżultati tal-istudji wara spezzjoni ta' rutina fis-siti talistudji kliniċi li żvelaw li l-istudju ma twettaqx f'konformità sħiħa ma' Prattika Klinika Tajba (GCP, Good Clinical Practice).
English: By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.
Maltese: Permezz tal-imblokk tar-riċetturi VEGF, din il-mediċina hija mistennija li tnaqqas il-provvista tad-demm liċ-ċelluli tal-kanċer, b'hekk tnaqqas it-tkabbir u l-firxa tal-kanċer.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza.
Maltese: Jekk inti qed tipparteċipa fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li qed jagħtihielek.
English: In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period.
Maltese: Flistudju, Zemfirza tqabbel ma' plaċebo (kura finta) u ngħata flimkien ma' mediċini bbażati fuq il-platinu waqt il-kura tal-bidu u sussegwentement waħdu waqt perjodu ta' manteniment.
English: You produce many different kinds of antibodies.
Maltese: Inti tirrpoduci diversi tipi ta' antibodies.
English: Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
Maltese: Immunomedics GmbH Otto-Rohm-Strabe 69 D-64293 Darmstadt Germany
English: Each vial contains stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
Maltese: Kull fjala fiha stannous chloride, sodium chloride, sodium potassium tartrate, sodium acetate, sucrose,
English: Kit - 48 months.
Maltese: Fjala 48 xahar.
English: In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
Maltese: In vitro, kien hemm rabta ta' 2-6% ma' lymphocytes.
English: • It is possible to have a serious allergic reaction to LeukoScan.
Maltese: Huwa possibli li jkollok rejazzjoni allergika serja bil-Leukoscan.
English: LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
Maltese: 22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
English: Hydrochloric Acid (Trace) Sodium Potassium Tartrate, Tetrahydrate Sodium Acetate, Trihydrate
Maltese: Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal
Maltese: - Kull fjala fiha 0.31mg sulesomab (IMMU-MN3 murine Fab'-SH antigranulocyte monoclonal
English: Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Maltese: INDIVIDWALI 0.31 mg sulesomab liofilizzat, stannous chloride u stabilizzanti
English: On the basis of two controlled clinical trials of LeukoScan to demonstrate the safety and effectiveness of this product for defining the presence and location of osteomyelitis, in a total of 175 evaluable patients, LeukoScan had a sensitivity of 88.2%, a specificity of 65.6%, an accuracy of 76.6%, a positive predictive value of 70.8%, and a negative predictive value of 85.5%.
Maltese: Fuq bazi ta' zewg studji li saru, f'total ta' 175 pazjent, Leukoscan wera sensittivita' ta' 88.2%, specificita ta 65.6%, akkuratezza ta' 76.6%, valur predittiv pozittiv ta' 70.8% u valur predittiv negattiv ta 85.
English: Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer.
Maltese: Kull tubu ghada tinghadd f'gamma scintillation counter, kalibratur jew radiochromatogram analyser.
English: Kit - Store in a refrigerator (2ºC - 8ºC).
Maltese: Zomm fi fridge (2-8°C).
English: Reconstituted and radiolabelled material - 4 hours.
Maltese: Materjal ippreparat 4 sieghat.
English: EXP MM/YYYY
Maltese: TWISSIJA/IET SPEĊJALI
English: At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
Maltese: Wara siegha, il-livell fid-demm kien 34% tal-bazi, 17% wara 4 sieghat u 7% wara 24 siegha.
English: LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
Maltese: Leukoscan huwa rikostitwit bi 0.5 ml ta' sodium chloride.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: LeukoScan is an antibody fragment which is linked to a radioactive substance called technetium.
Maltese: Leukoscan huwa framment ta' antibody li huwa marbut ma' sustanza radjuattiva msejha technetium.
English: One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Fjala fiha 0.31 mg Leukoscan monoclonal antibody.
English: Do not store above 25°C.
Maltese: Izzomx f'temperatura iktar minn 25°C.
English: There was essentially no difference in the detection of the presence or absence of osteomyelitis between the 1-2 hour timepoint and the 5-8 hour timepoint after injection.
Maltese: Ma kien hemm l-ebda differenza bejn 1-2 siegha u 5-8 sieghat ghad-dijanjosi ta' infezzjoni.
English: The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Maltese: Il-prodott biex jittiehdu r-ritratti, technetium-99m Leukoscan (technetium-99m sulesomab) jigi wara li zzid 0.5 sodium chloride fil-fjala ta Leukoscan u wara zzid 1100 MBq ta' sodium pertechnetate (Tc99m) f'1ml ta' sodium chloride ghall-injezzjoni.
English: The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results.
Maltese: Ir-rizultati klinici juru li fid-diversi tipi ta' infezzjoni fl-ghadam, Leukoscan jista' juri rizultati differenti.
English: You will receive a single dose of 0.25 mg of LeukoScan.
Maltese: Inti tircevi doza wahda ta' 0.25mg ta' Leukoscan.
English: Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′-SH antigranulocyte monoclonal antibody fragments) for the preparation of 99mTc labelled LeukoScan.
Maltese: Kull fjala fiha 0.31 mg sulesomab (IMMU-MN3 framment ta antikorpu monoklonali antigranulocita) ghall-preparazzjoni ta' Leukoscan immarkat bil Tc99m.
English: LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes.
Maltese: Leukoscan (sulesomab) huwa tip specjali ta' antibody li jorbot ma' wicc ic-celluli bojod tad-demm.
English: SPECT acquisition parameters recommended are: 60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
Maltese: Ghal SPECT, dawn huma il-parametri li ghandhom jintuzaw: 60 ritratt fuq 360 grad, 30 sekonda kull ritratt, matrix ta' 64 x 64.
English: In a subgroup of patients in whom LeukoScan was compared directly to the currently available 111Inlabelled (occasionally 99mTc-labelled) autologous white blood cell (WBC) scanning test, LeukoScan showed a statistically significant increase in sensitivity over that achieved by WBC scanning (87.7% vs. 72.6%, p = 0.003 by McNemar's Test), with no discernible decrease in specificity as compared to WBC
Maltese: F'grupp izghar ta' pazjenti, Leukoscan gie mqabbel ma ritratti li ttiehdu wara li il WBC gew marbuta ma In111 jew Tc99m u kien hemm zieda ta' sensitivita' ta' Leukoscan meta mqabbel ma ritratti li ttiehdu bil WBC (87.7% vs 72.6%, p = 0.003 bit-test ta' McNemar) minghajr lebda tnaqqis flispecificita mqabbel mal WBC (67.1% vs 69.4%).
English: The antibody (IMMU-MN3) recognizes an antigenic structure shared by a surface glycoprotein (NCA-90) of granulocytes and the tumour marker, carcinoembryonic antigen (CEA).
Maltese: L-antibody (IMMU-MN3) jaghraf struttura NCA-90 fuq wicc il-WBC u il-marker tumorali CEA.
English: In a single-group, open-label, uncontrolled study of 53 patients with acute or chronic infections of unknown origin or extent, doses of LeukoScan from 0.1 mg to 1.0 mg were studied.
Maltese: Fi studju fuq 53 pazjent b'infezzjonijet akuti jew kronici, dozi ta' 0.1 sa 1.0 mg ta' Leukoscan gew studjati.
English: The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99mTc pertechnetate (approximately 1.2 ml).
Maltese: Wara, jizdiedu 1ml ta' sodium Id-doza fil-kbar hija ta' 0.25 mg Fab markata bi 900 + 200 technetium Tc99m pertechnetate
English: 0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
Maltese: It-tabib tieghek jipprepara il-Leukoscan u s-sostanza radjuattiva bi 740-1110MBq ta' technetium.
English: Medicinal product subject to medical prescriptio
Maltese: TAL-PRODOTT MEDIĊINALI
English: LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation.
Maltese: Leukoscan jista' jintuza 10 minuti wara li jigi ippreparat u qabel ma jghaddu 4 sieghat.
English: Pharmacotherapeutic group: Diagnostic Radiopharmaceuticals.
Maltese: Kategorija farmakoterapewtika:
English: NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Maltese: U MNEJN GĦANDU JINGĦATA Leukoscan 0.31 mg, trab ghal soluzzjoni ghall-injezzjoni 0.31 mg sulesomab liofilizzat, stannous chloride u stabilizzanti
English: Single photon emission computed tomography (SPECT) imaging can also be conducted and may aid in differentiating osteomyelitis from soft tissue infections.
Maltese: Single Photon Emission Computed Tomography (SPECT) jista' jsir ukoll u dan jista' jghin biew tiddistingwi bejn infezzjoni fl-ghadam minn dik fil-gilda.
English: An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Maltese: Jidher illi Leukoscan jista' jbiddel it-terapija fi 50.2% jew itejjeb ir-rizultat kliniku fi 43.4% minn dawn il 175 pazjent.
English: The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration.
Maltese: Kien hemm tnaqqis bin-nofs kull 1.5 siegha u ilprodott jigi eliminat mill-kliewi b'41% jigi eliminat fl-urina wara 24 siegha.
English: NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection
Maltese: TAL-PRODOTT MEDIĊINALI Leukoscan 0.31 mg, trab ghal soluzzjoni ghall-injezzjoni