FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2001
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Frar, 2001
English: Powder and solvent for concentrate for solution for infusion (powder for sterile concentrate).
Maltese: Trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni (trab għal konċentrat sterili).
English: Uric acid levels were <2 mg/dl in 96% of patients in the two arms containing rasburicase and 5% of patients in the allopurinol arm at 4 hours of the day 1 dose.
Maltese: Il-livelli tal-aċidu uriku kienu <2 mg/dl f'96% tal-pazjenti fiż-żewġ fergħat li kellhom rasburicase u f'5% tal-pazjenti fil-fergħa ta' allopurinol, wara 4 sigħat mid-doża tal-ewwel ġurnata.
English: Tabulated list of adverse reactions MedDRA Organ system classes
Maltese: Sistema talklassifika talorgani MedDRA
English: Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
Maltese: L-antikorpi kontra rasburicase nstabu f'pazjenti ttrattati, u voluntiera b'saħħithom li ngħataw rasburicase.
English: Reconstitution results in a solution with a concentration of 1.5 mg/ml rasburicase to be further diluted with sodium chloride 9 mg/ml (0.9%) intravenous solution.
Maltese: Ir-rikostituzzjoni tirriżulta f'soluzzjoni li huwa konċentrat ta' 1.5 mg /ml ta' rasburicase, u li għandu jiġi dilwit aktar b'soluzzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
Maltese: L-ossidazzjoni enzimatika ta' l-aċidu uriku jwassal għall-ifformar stojkjometriku ta' hydrogen peroxide.
English: Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.
Maltese: Peress li rasburicase hija enzima fiha innifisha, huwa improbabbli li tkun involuta f'interazzjoni ma' medicina oħra.
English: (frequency not known) which may be fatal - low blood pressure (hypotension) - wheezing or difficulty in breathing (bronchospasm) - blood disorders such as a disorder of the blood in which red blood cells are abnormally broken down (haemolysis), destroyed (haemolytic anaemia), or abnormal blood pigment levels
Maltese: - tħarħir jew qtugħ ta' nifs (bronkospażmu) - disturbi fid-demm bħal disturb tad-demm fejn iċ-ċelluli ħomor tad-demm ikunu mkissrin b'mod mhux normali (emolisi), meqruda (anemija emolitika) jew livelli mhux normali tal-pigment taddemm (metemoglobinemija)
English: Pack of 3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
Maltese: Pakkett ta' 3 kunjetti ta' 1.5 mg rasburicase u 3 ampulli ta' 1 ml solvent.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1
English: Fasturtec must be reconstituted with the entire volume of the supplied solvent (e.g. 1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Maltese: Fasturtec għandu jiġi rikostitwit bil-volum sħiħ tas-solvent fl-ampulla ipprovduta (kunjett ta' 1.5 mg rasburicase għandu jiġi rikostitwit b'1 ml tas-solvent ta' l-ampulla; kunjett ta' 7.5 mg rasburicase għandu jiġi rikostitwit b'5 ml tas-solvent ta' l-ampulla).
English: The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Maltese: Id-diġestjoni enzimatika ta' rasburicase fuq l-aċidu uriku, li jinbidel fl-allantoina u jipproduċi hydrogen peroxide u l-anemija emolitika, jew il-metemoglobinemija,
English: Fasturtec is injected slowly into a vein, which should take about 30 minutes.
Maltese: Fasturtec huwa injettat bil-mod ġol-vina, f'ħin ta' madwar 30 minuta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 1.5 mg
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal rasburicase 1.5 mg
English: Methaemoglobinaemia has been reported in patients receiving Fasturtec.
Maltese: Il-metemoglobinemija ġiet irrapportata f'pazjenti li ħadu Fasturtec.
English: Frequency not known (frequency cannot be estimated from the available data) - involuntary muscle movements (muscle contraction involuntary).
Maltese: - movimenti involontarji tal-muskolu (ġbid involontarju tal-muskolu).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for rasburicase 7.5 mg
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal rasburicase 7.5 mg
English: The mean terminal half-life was similar between paediatric and adult patients and ranged from 15.7 to 22.5 hours.
Maltese: Il-medja tal-half-life terminali kienet simili bejn il-pazjenti pedjatriċi u dawk adulti u kienet tvarja bejn 15.
English: In clinical trials, haematological disorders such as haemolysis, haemolytic anaemia and methaemoglobinaemia are uncommonly caused by Fasturtec.
Maltese: Fi provi klinici, il-mard ematologiku bħall-emolisi, l-anemija emolitika, u l-metemoglobinemija, mhux komunement ikkawżati minn Fasturtec.
English: Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni jew d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
Maltese: ta' ħġieġ ċar (tip I), b'tapp tal-lasktu, u s-solvent f'ampulla ta' 2 ml, ta' ħġieġ car (tip I).
English: • coughing or wheezing
Maltese: TRAB/KUNJETT
English: The increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients.
Maltese: Iż-żieda ta' hydrogen peroxide, fuq il-livelli ambjentali, jista' jitneħħa permezz t'antiossidanti naturali, li jinsabu fil-ġisem, u l-uniku riskju żejjed huwa l-emolisi f'dawk li għandhom nuqqas ta' G6PD, u pazjenti li jbatu minn anemija ereditarja.
English: Metabolism
Maltese: FARMAĊEWTIKU
English: Store in a refrigerator (2°C - 8°C).
Maltese: Ahżen fi friġġ (2 °Ċ - 8 °Ċ).
English: NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Maltese: Fasturtec 1.5 mg/ml trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni rasburicase
English: In long term safety studies, an analysis of data from 867 paediatric patients (mean age 7.3 years, range 0 to17) treated with rasburicase at 0.20 mg/kg/day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
Maltese: 7.3 snin, marġni ta' etajiet minn 0 sa 17) trattati bi rasburicase f'doża ta' 0.20 mg/kg/jum minn 1 sa 24 jum (prinċipalment 1 sa 4 ijiem) uriet konsistenza mar-riżultati ta'studji kliniċi pivitali fuq-sigurta' u effikaċja.
English: Package leaflet: Information for the user Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion rasburicase
Maltese: Informazzjoni għall-utent Fasturtec 1.5 mg/ml trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni rasburicase
English: G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
Maltese: M'għandhiex tintuża soluzzjoni tal-glukosju biex tiddilwi, dovut għal inkompatibilità potenzjali.
English: 1.5 mg/1 ml
Maltese: 3 kunjetti u 3 ampulli 1.5 mg/1 ml
English: These are rare (may affect up to 1 in 1,000 people).
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna):
English: The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
Maltese: ta' ħġieġ ċar (tip I), b'tapp tal-lasktu, u s-solvent f'ampulla ta' 5 ml, ta' ħġieġ ċar (tip I).
English: A cross-study comparison revealed that after administration of rasburicase at 0.15 or 0.20 mg/kg, the geometric mean values of body-weight normalized clearance were approximately 40% lower in Japanese (n=20) than that in Caucasians (n=26).
Maltese: intwera li wara l-għoti ta' rasburicase f'dożi ta' 0.15 jew 0.2 mg/kg, il-valuri medji ġeometriċi tattneħħija, nnormalizzati skont il-piż tal-ġisem, kienu madwar 40 % inqas f'pazjenti Ġappuniżi (n=20) milli f'pazjenti Kawkażi (n=26).
English: - Anaphylaxis - Anaphylactic shock*
Maltese: -Anafilassi - Xokk anafilattiku*
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/170/002
English: Fasturtec will be administered at the same time as other medicines that may also cause side effects.
Maltese: Fasturtec ser jingħata flimkiem bħal mediċini oħra li jista jkollhom effetti sekondarji.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Maltese: Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il-ġeni, uriet li m'hemmx riskju speċjali fil-bniedem.
English: Pharmacotherapeutic group: Detoxifying agents for antineoplastic treatment, ATC code: V03AF07.
Maltese: Mediċini detossifikanti għat-trattament kontra n-neoplażmi, kodiċi
English: The uric acid response rate (proportion of patients with plasma uric acid levels ≤7.5 mg/dl from day 3 to day 7 after initiation of antihyperuricemic treatment) was 87% in arm A, 78% in arm B, and 66% in arm C. The response rate in arm A was significantly greater than in arm C (p=0.0009); the response rate was higher for arm B compared to arm C although this difference was not statistically significant.
Maltese: Ir-rata ta' rispons għall-aċidu uriku (il-persentaġġ ta' pazjenti b'livelli ta' aċidu uriku fil-plażma ≤7.5 mg/dl mit-3 ġurnata sas-7 ġurnata wara li tinbeda l-kura kontra l-livell għoli ta' aċidu uriku fid-demm) kien ta' 87% fil-fergħa A, 78% fil-fergħa B, u 66% fil-fergħa Ċ.
English: Fasturtec is supplied as a pack of:
Maltese: Is sustanza dilwita qabel l-infużjoni:
English: Clearance of rasburicase was ca. 3.5 ml/h/kg.
Maltese: It-tneħħija ta' rasburicase kienet ta' madwar 3.5 ml /siegħa/kg.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES
Maltese: BIT-TRAB u 3 AMPULLI BIS-SOLVENT
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: PAKKETT TA' 3 KUNJETTI
English: Paediatric population As no adjustment is necessary, the recommended dose is 0.20 mg/kg/day.
Maltese: Peress li m'hemmx bżonn ta' xi aġġustament, id-doża rrakkomandata hija ta' 0.20 mg/kg/ġurnata.
English: As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
Maltese: Peress li l-metaboliżmu huwa mistenni li jsir permess ta' l-idrolisi tal-peptide, indeboliment filfunzjoni tal-fwied mhux mistenni li jaffetwa l-komportament farmakokinetiku.
English: - Headache +
Maltese: - Uġigħ ta'
English: Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.
Maltese: Minħabba l-mekkaniżmu ta' kif jaħdem Fasturtec, doża eċċessiva twassal ghall-livelli baxxi jew assenti ta' l-aċidu uriku fil-plażma u formazzjoni aktar ta' hydrogen peroxide.
English: Do not freeze
Maltese: Tqala u treddigħ
English: The most commonly reported adverse reactions were nausea, vomiting, headache, fever, and diarrhea.
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni kienu dardir, rimettar, uġigħ ta' ras, deni u dijarea.
English: Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Maltese: Għat-trattament u profilassi ta' stat akut ta' livell għoli ta' aċidu uriku fid-demm, biex jimpedixxi l iżvilupp ta' insuffiċjenza renali akuta, fl-adulti, fit-tfal u fl-adolexxenti (ta' etajiet minn 0 sa 17-il sena) li għandhom tumur malinn tad-demm, b'tumur kbir jew estensiv, u f'riskju li jiżviluppaw diżintegrazzjoni mgħaġġla tat-tumur jew nixfa tat-tumur, fil-bidu tal-kimoterapija.
English: Powder in vial: store in a refrigerator (2°C - 8°C).
Maltese: Trab fil-kunjett: aħżen fi friġġ (2°Ċ - 8°Ċ).
English: In humans, uric acid is the final step in the catabolic pathway of purines.
Maltese: Fil-bniedem, l-aċidu uriku huwa l-prodott finali fil-proċess kataboliku tal-purini.
English: NAME OF THE MEDICINAL PRODUCT Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion.
Maltese: Fasturtec 1.5 mg/ml trab u solvent għall-konċentrat għal soluzzjoni għall-infużjoni.
English: Date of renewal: 06/01/2011
Maltese: Data tat-tiġdid: 06/01/2011
English: D-38110 Braunschweig Germany
Maltese: D-38110 Braunschweig
English: Yttrium (90Y) is a beta pure emitter.
Maltese: Yttrium (90Y) hu emittent pur beta.
English: E-28045 Madrid Tel: + 34 915 062 940 info@nucliber.com
Maltese: Madrid Tel: + 34 915 062 940 info@nucliber.com
English: Gastro-intestinal content
Maltese: Kontenut gastrointestinali
English: EXP {MM/YYYY} (12h CET)
Maltese: {ĠĠ/XX/SSSS} (12h CET)
English: Do not use Yttriga:
Maltese: Tużax Yttriga:
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hydrochloric acid (0.04 M) 6.2 Incompatibilities
Maltese: 6.1 Lista ta' sustanzi mhux attivi Hydrochloric acid (0.04 M) 6.2 Inkompatibilitajiet
English: Absorbed dose per unit activity administered (mGy/MBq)
Maltese: Doża assorbita għal kull unit ta' attività mogħtija (mGy/MBq)
English: Manufacturer
Maltese: MANIFATTURA
English: It decays by emission of beta radiation of 2.281 MeV (99.98 %) of maximal energy to stable Zirconium (90Zr).
Maltese: Jinbidel bil-mod bir-radjuattività bl-emissjoni ta' radjazzjoni beta ta' 2.281 MeV (99.98 %) ta' enerġija massimali għal Zirconium (90Zr) stabbli.
English: Yttrium (90Y) has a half-life of 2.67 days (64.1 hours).
Maltese: Yttrium (90Y) għandu half-life ta' 2.67 ġranet (64.1 siegħa).
English: In the liver, 18 % of the injected activity is taken up 5 min after injection.
Maltese: Fil-fwied, 18% ta' lattività injettata tkun assorbita f'5 minuti wara l-injezzjoni.
English: Imaging Equipment Limited The Barn, Manor Farm, Church Lane Chilcompton, Somerset BA3 4 HP SalesAdmin@imagingequipment.co.uk
Maltese: Imaging Equipment Limited The Barn, Manor Farm, Church Lane Chilcompton, Somerset BA3 4 HP
English: Up to 12 days from the date of manufacture.
Maltese: Sa 12-il ġurnata mid-data tal-manifattura.
English: Colon
Maltese: Kolon
English: (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
Maltese: (li tikkorrispondi għal 0.005-15 mikrogrammi ta' Yttrium [90Y]) (bħala Yttrium [90Y]
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi,ara sezzjoni 6.1.
English: METHOD OF ADMINISTRATION in vitro labelling
Maltese: Ittikkettar in vitro
English: The volume is 0.02-5 ml.
Maltese: Il-volum hu 0.02-5 ml.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/01/2006
Maltese: Data tal-ewwel awtorizzazzjoni: 19/01/2006
English: At 1 and 24 hours, blood radioactivity decreases from 11.0 % to 0.14 % of the administered activity.
Maltese: Wara siegħa u 24 siegħa, ir-radjuattività tad-demm tinżel minn 11.0 % sa 0.14% ta' l-attività mogħtija.
English: Thyroids
Maltese: Tirojdi
English: Liver uptake decreases then to 8.4 % 24 hours after injection.
Maltese: L-assorbiment tal-fwied imbagħad jonqos għal 8.4% 24 siegħa wara l-injezzjoni.
English: 5 years (17 kg)
Maltese: 5 snin (17 kg)
English: Yttrium (90Y)-labelled medicinal products are contraindicated in the following case:
Maltese: Yttrium (90Y)- prodotti mediċinali tikkettati huma kontra-indikati fil-każ li ġej:
English: - The other ingredient is hydrochloric acid (0.04 M).
Maltese: - Is-sustanza l-oħra hi hydrochloric acid (0.04 M).
English: The volume is 0.02-3 ml.
Maltese: Il-volum hu 0.02-- 3 ml.
English: For this product the effective dose to a 70 kg adult resulting from an intravenously injected activity of 1 GBq is 665 mSv.
Maltese: Għal dan il-prodott, id-doża effettiva għal adult li jiżen 70 kg li tirriżulta minn attività injettata ġol vina ta' 1 GBq hi 665 mSv.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/322/001 (3 ml V-shaped vial) EU/1/05/322/002 (10 ml flat bottom vial)
Maltese: EU/1/05/322/001 (Kunjett ta' 3 ml forma ta' V)
English: METHOD OF ADMINISTRATION For in vitro radiolabelling.
Maltese: Għal radjutikkettar in vitro.
English: 1 g of the chelating agents should be administered by slow intravenous injection over 3 - 4 minutes or by infusion (1 g in 100 - 250 ml of dextrose, or normal saline).
Maltese: sa 4 minuti jew bl-infużjoni (1 g f'100 - 250 ml ta' dextrose, jew ilma bil-melħ normal).
English: OTHER
Maltese: Jis
English: 10 years (30 kg)
Maltese: 10 snin (30 kg)
English: Yttriga is contraindicated in Pregnancy.
Maltese: Tqala Yttriga hu kontra-indikat fit-Tqala.
English: The following preparations must be available in medical institutions, which use Yttriga for labelling of carrier molecules for therapeutic purposes: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) or - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
Maltese: Il-preparazzjonijiet li ġejjin iridu jkunu disponibbli f'istituzzjonijiet mediċi, li jużaw Yttriga għall ittikkettar tal-molekuli carrier għal raġunijiet terapewtiċi: - Ca-DTPA (Trisodium calcium diethylenetriaminepentaacetate) jew - Ca-EDTA (Calcium disodium ethylenediaminetetraacetate)
English: Yttriga is intended for in vitro labelling of medicinal products which are subsequently administered by the approved route.
Maltese: L-għan ta' Yttriga hu l-ittikkettar in vitro tal-prodotti mediċinali li huma sussegwentement mogħtija mir-rotta approvata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time (corresponding to 0.005-15 micrograms of Yttrium [90Y]) (as Yttrium [90Y] chloride).
Maltese: 1 ml ta' soluzzjoni sterili fiha 0.1-300 GBq Yttrium (90Y) fid-data u l-ħin tar-referenza (li jikkorrispondu għal 0.005-15 mikrogrammi ta' Yttrium [90Y]) (bħala Yttrium [90Y] chloride).
English: Radiolabelling of medicinal products, such as monoclonal antibodies, peptides or other substrates, with Yttrium (90Y) chloride is very sensitive to the presence of trace metal impurities.
Maltese: Ir-radjutikkettar tal-prodotti mediċinali, bħal antikorpi monoklonali, peptidi jew sottostrati oħra, b'Yttrium (90Y) chloride hu sensittiv ħafna għall-preżenza ta' impuritajiet ta' traċċi metalliċi.
English: In bone, percentage of injected activity increases from 3.1 % at 5 min to 18 % at 6 hours and then decreases with time.
Maltese: Fl-għadam, il-persentaġġ ta' l-attività injettata tiżdied minn 3.1% wara 5 minuti għal 18% wara 6 sigħat u mbagħad tonqos biż-żmien.
English: Yttrium (90Y) chloride is produced by decay of its radioactive precursor Strontium (90Sr).
Maltese: Yttrium (90Y) chloride hu prodott bit-taħsir tal-prekursur radjuattiv tiegħu Strontium (90Sr).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Yttrium (90Y) chloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Yttrium (90Y) chloride
English: Hydrochloric acid (0.04 M)
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Hydrochloric acid (0.04 M)
English: Ileum
Maltese: Ileu
English: 2.30 E-02 3.46 E-02 8.06 E-02 1.15 E-01 2.30 E-01 6.91 E-01
Maltese: 2.30 E-02 3.46 E-02 8.06 E-02 1.15 E-01 2.30
English: Act.: (Y) GBq/vial
Maltese: (Y)________ GBq/kunjett
English: Faecal and urinary elimination is slow: about 31 % of the administered activity is eliminated in 15 days.
Maltese: l-ippurgar u l-awrina hi bil-mod: madwar 31% ta' l-attività mogħtija titneħħa fi 15-il ġurnata.
English: 15 years (50 kg)
Maltese: 15-il sena (50 kg)
English: Pregnancy Yttrium (90Y)-labelled medicinal products are contraindicated in established or suspected pregnancy or when pregnancy has not been excluded (see section 4.3).
Maltese: Tqala Il-prodotti mediċinali Yttrium (90Y)-tikkettati huma kontra-indikati fi tqala stabbilita jew issuspettata jew meta t-tqala ma ġietx eskluża (ara sezzjoni 4.3).
English: 1.51 E-02 2.26 E-02 5.28 E-02 7.55 E-02 1.51 E-01 4.53 E-01
Maltese: 1.51 E-02 2.26 E-02 5.28 E-02 7.55
English: Stomach
Maltese: Pulmuni
English: 8.60 E-03 1.29 E-02 3.01 E-02 4.30 E-02 8.60 E-02 2.58 E-01
Maltese: E-03 1.29 E-02 3.01 E-02 4.30 E-02 8.60
English: 7.90 E-02 1.18 E-01 2.76 E-01 3.95 E-01 7.90 E-01 2.37 E+00 Skeletal muscle 6.12 E-04 9.17 E-04 2.14 E-03 3.06 E-03 6.12 E-03 1.83 E-02 Skin
Maltese: E-01 2.37 E+00 Muskolu skeltrali 6.12 E-04 9.17 E-04 2.14 E-03 3.06 E-03 6.12 E-03 1.83 E-02
English: - 1 ml sterile solution contains 0.1-300 GBq Yttrium (90Y) on the reference date and time
Maltese: - Is-sustanza attiva hi Yttrium (90Y) chloride. - 1ml ta' soluzzjoni sterili fiha 0.1-300 GBq Yttrium (90Y) fid-data u ħin tar- referenza
English: Further information on the preparation of the product is given in section 12.
Maltese: Aktar tagħrif dwar il-preparazzjoni tal-prodott qed jingħata fis-sezzjoni 12.
English: 7.34 E-02 1.10 E-01 2.57 E-01 3.67 E-01 7.34 E-01 2.20 E+00
Maltese: 7.34 E-02 1.10 E-01 2.57 E-01 3.67 E-01 7.34
English: In this leaflet:
Maltese: Act.:
English: 6.47 E-02 9.70 E-02 2.26 E-01 3.23 E-01 6.47 E-01 1.94 E+00
Maltese: E-02 2.26 E-01 3.23 E-01 6.47 E-01 1.94 E+00
English: Each 10ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Maltese: Kull kunjett ta' 10ml fih 0.1-300 GBq, li jikkorrispondi għal 0.005-15 mikrogrammi ta' Yttrium (90Y), fid-data u l-ħin tar-referenza.
English: Colourless type I glass vial of 3 ml with a V-shapped bottom or a colourless type I glass vial of 10 ml with a flat bottom with a silicon stopper, closed with an aluminium seal.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ ta' tip I trasparenti ta' 3 ml b'qiegħ forma ta' V jew kunjett tal-ħġieġ tat-tip I trasparenti ta' 10 ml b'qiegħ ċatt b'tapp tas-silikon, magħluq b'siġill ta' l-aluminju.
English: Time-points for measurements were 5 min, 1, 6, 24, 96 and 360 hours.
Maltese: 6, 24, 96 u 360 siegħa.
English: Act.: {Y}________GBq/vial Cal.: {DD/MM/AAAA} (12h CET)
Maltese: Vol.: {Z} ml Act.: (Y)________ GBq/kunjett
English: Particular care should be taken when administering radioactive medicinal products to children and adolescents (from 2 to 16 years old).
Maltese: Għandha tingħata attenzjoni partikulari meta ikunu qed jingħataw prodotti mediċinali radjuattivi lit tfal u lill-adoloxxenti (minn 2 sa 16-il sena).
English: HOW TO STORE YTTRIGA
Maltese: X'fih Yttriga
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10X.
Maltese: Radjufarmaċewtiċi terapewtiċi oħra, Kodiċi ATC:
English: Fax +49- 30-941084-470 e-mail: radiopharma@ezag.de
Maltese: Fax +49- 30-941084-470
English: 1 year (10 kg)
Maltese: sena (10 kg)
English: Radiopharmaceutical precursor, solution.
Maltese: Prekursur radjufarmċewtiku, soluzzjoni.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings and receipt, storage, use, transfer and disposal are subject to the regulations and appropriate licences of the competent authorities.
Maltese: Ir-Radjufarmaċewtiċi għandhom ikunu rċevuti, użati u mogħtija minn persuni awtorizzati biss f'ambjent kliniku għal ta' l-apposta, u l-irċevuta, l-ħażna, l-użu, it-trasferiment u r-rimi huma suġġetti għar-regolamenti u l-liċenzji adattati ta' l-awtoritajiet kompetenti.
English: Kidneys
Maltese: Pożoloġija