FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 mcg solution for injection interferon beta-1a
Maltese: U MNEJN GĦANDU JINGĦATA Rebif 8.8 mcg soluzzjoni għall-injezzjoni Interferon beta-1a
English: The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection.
Maltese: Il-posoloġija rakkomandata ta' Rebif hi 44 mikrogrammi tlett darbiet fil-ġimgħa permezz ta' injezzjoni taħt il-ġilda.
English: INFORMATION IN BRAILLE rebif 22
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a Initiation pack
Maltese: Rebif 8.8 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Rebif 22 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest Interferon beta-1a Pakkett inizjali
English: • Remove RebiSlide from the injection site.
Maltese: • Agħżel sit għall-injezzjoni.
English: Composition: Each pre-filled pen contains 44 micrograms (12 MIU) of interferon beta-1a in 0.5 mL solution.
Maltese: Kull pinna mimlija għal-lest fiha 44 mikrogrammi (12 MIU) ta' interferon beta-1a f'soluzzjoni ta' 0.5 mL.
English: • Before treatment with Rebif, read carefully and follow the “RebiDose Instructions for Use” provided in a separate booklet, in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Maltese: • Qabel tibda l-kura b'Rebif, aqra sew u segwi “RebiDose Istruzzjonijiet għal użu” ipprovduti fi ktejjeb separat, dan sabiex tnaqqas ir-riskju ta' nekrożi fis-sit ta' l-injezzjoni (qsim fil-ġilda u qerda tat-tessut) li ġiet rappurtata f'pazjenti kkurati b'Rebif.
English: After a single dose, intracellular and serum activity of 2'5'OAS synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Maltese: Wara doża waħda, attività intraċellulari u tas-serum ta' 2-5A sintetaċi u konċentrazzjonijiet tasserum ta' beta-2 mikroglobulina u neopterina jogħlew fi żmien 24 siegħa, u jibdew jonqsu fi żmien jumejn.
English: • a dry cotton ball or gauze
Maltese: • Aħsel idejk sewwa bl-ilma u bis-sapun.
English: The device (RebiSmart or RebiSlide) containing a pre-filled cartridge of Rebif must be stored in the device storage box in a refrigerator (2°C - 8°C).
Maltese: L-apparat (RebiSmart jew RebiSlide) fihom skartoċċ mimli bil-lest ta' Rebif li għandu jinħażen filpakkett oriġinali fil-friġġ (2°C - 8°C).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg solution for injection interferon beta-1a
Maltese: U MNEJN GĦANDU JINGĦATA Rebif 22 mcg soluzzjoni għall-injezzjoni Interferon beta-1a
English: • Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome).
Maltese: • Emboli tad-demm fil-vini ż-żgħar li jistgħu jaffettwaw il-kliewi tiegħek (purpura tromboċitopenika jew sindromu uremiku emolitiku).
English: Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended.
Maltese: Għalhekk, jekk jiġu osservati l-karatteristiċi kliniċi ta' TMA, ittestjar addizzjonali tal-livelli tal-plejtlits fid-demm, LDH fis-serum, films tad-demm u l-funzjoni tal-kliewi huma rakkomandati.
English: Patients were randomised in a double-blind manner to either Rebif 44 micrograms given three times per week, Rebif 44 micrograms once weekly, or placebo.
Maltese: Il-pazjenti ntgħażlu b'mod każwali b'mod double blind biex jieħdu jew Rebif 44 mikrogramma mogħti tlett darbiet kull ġimgħa, Rebif 44 mikrogramma darba f'ġimgħa, jew plaċebo.
English: • A new RebiDose and
Maltese: • Rebidose ġdid u
English: Caution should be exercised when administering Rebif in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. antiepileptics and some classes of antidepressants.
Maltese: Għandha ssir attenzjoni meta jingħata Rebif flimkien ma' prodotti mediċinali oħra li għandhom indiċi terapewtiku qasir u li jiddependu ħafna fuq is-sistema hepatic cytochrome P450 sabiex jitnaddfu eż :.
English: A. Cap
Maltese: A.
English: • Rebif is given by injection under the skin (subcutaneously) using a pre-filled pen called “RebiDose”.
Maltese: • Rebif jingħata (b'injezzjoni taħt il-ġilda) (subkutaneja) b'użu ta' pinna mimlija għall-lest imsejħa “RebiDose”.
English: G. Safety guard H. Needle
Maltese: UŻATI JEW SKART MINN DAWN
English: Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
Maltese: Avvenimenti ġew irrappurtati f'diversi punti ta' ħin matul ilkura u jistgħu jseħħu wara diversi snin ta' kura b'interferon-beta.
English: Serum neutralising antibodies against interferon beta-1a may develop.
Maltese: MIU*) ta' interferon beta-1a**.
English: Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities.
Maltese: Pazjenti kkurati b'Rebif jistgħu jiżviluppaw abnormalitajiet ġodda jew aggravati tat-tirojde.
English: Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 times ULN).
Maltese: Rebif g ħandu jinbeda b'attenzjoni f'pazjenti bi storja ta' disturbi tal-fwied sinjifikattiva, evidenza klinika ta' mard tal-fwied, abbuż ta' l-alkoħol u livell għoli ta'serum ALT (>2.5 drabi
English: General recommendations
Maltese: Statistika tal
English: For multidose use.
Maltese: Għal doża multipla.
English: •Before treatment with Rebif, read carefully and follow the “RebiDose Instructions for Use” provided in a separate booklet, in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Maltese: • Meta tagħmel dan jekk jogħġbok aqra sew u segwi, “l-istruzzjonijiet għall-użu ta' RebiDose” ipprovduti separatament fil-ktejjeb.
English: • Remove RebiSmart from the injection site.
Maltese: •Neħħi RebiSmart mis-sit tal-injezzjoni.
English: No specific risk factors have been identified.
Maltese: Lebda fatturi ta' riskju ma ġew identifikati.
English: Children and teenagers Side effects in children and teenagers are similar to those observed in adults.
Maltese: Tfal u adolexxenti L-effetti sekondarji fit-tfal u fl-adolexxenti huma simili għal dawk osservati fl-adulti.
English: Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: These are natural substances that transmit messages between cells.
Maltese: Dawn huma sustanzi naturali li jibgħati messaġġi bejn iċ-ċelluli.
English: • Serious skin reactions - some with mucosal lesions
Maltese: • Uġigħ fil-muskoli u fil-ġogi
English: 18 months.
Maltese: 2 skrataċ.
English: • Remove RebiDose from the injection site.
Maltese: • Neħħi RebiDose mis-sit tal-injezzjoni.
English: Patients who have experienced a single clinical event The usual dose is 44 micrograms (12 million IU) given three times per week.
Maltese: Pazjenti li kellhom avveniment kliniku wieħed Id-doża normali hi 44 mikrogrammi (12 miljun IU) mogħtija tlett darbiet fil-ġimgħa.
English: Rebif, like other interferons beta, has a potential for causing severe liver injury including acute hepatic failure (see section 4.8).
Maltese: Rebif bħal interferons beta oħra, għandu l-potenzjal li joħloq periklu serju għall-fwied li jinkludi kollass epatiku akut (ara sezzjoni 4.8).
English: Portugal
Maltese: European Medicines Agency
English: EXP
Maltese: ©EMEA 2007
English: Suomi/Finland
Maltese: EMEA/H/C/137
English: What TESLASCAN contains - The active substance is mangafodipir trisodium.
Maltese: TESLASCAN hu sustanza għall-infużjoni (drip fil-vina) li jkun fiha s-sustanza attiva mangafodipir trisodium.
English: HIGIEA d.o.o.
Maltese: TESLASCAN waqt l-MRI.
English: Mangafodipir trisodium
Maltese: Kif jintuża TESLASCAN?
English: Pharmacotherapeutic group: Paramagnetic MRI contrast medium, ATC Code: V08C A05
Maltese: Fis-sejbien ta' leżjonijiet fil-frixa, MRI msaħħaħ bitTESLASCAN kien effettiv daqs CT spirali.
English: In clinical trials with Teslascan, adverse reactions have been reported with the following frequencies given in the table below (very common ≥1/10; 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, not known (cannot be estimated from the available data).
Maltese: L-iktar effetti sekondarji komuni b'TESLASCAN (li dehru f'bejn 1 u 10 pazjenti minn 100) huma luġigħ ta' ras, id-dardir (tħossok ma tiflaħx), fwawar u sensazzjoni ta' sħana.
English: About 15-20 % of the manganese is eliminated in the urine within the first 24 hours, most of the remainder is excreted in the faeces over the following 4 days.
Maltese: L-immaġni jibdew jissaħħu bejn 15 u 20 minuta wara li tinbeda l-infużjoni, u l-effett idum xi 4 sigħat.
English: CZ-140 28 Praha 4 Tel: + 420 224 446 179
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Each ml contains 7.57 mg of anhydrous mangafodipir trisodium, 0.01 mmol (10 μmol), equivalent to 50 ml contains 378.5 mg of anhydrous mangafodipir trisodium, 0.50 mmol (500 μmol), equivalent to
Maltese: Huwa jispjega kif il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ivvaluta l-istudji mwettqa, biex jissodisfa ir-rakkomandazzjonijiet tagħhom dwar kif tintuża l-mediċina.
English: The recommended dose is 0.5 ml/kg bodyweight (5 µmol/kg bodyweight).
Maltese: TESLASCAN jintuża bħala infużjoni fil-vina ta' darba b'doża ta' 0.5ml għal kull kilogramma li jiżen il-pazjent.
English: Pharma-Cos Ltd Triq C. Portanier MT-Santa Venera HMR 11 Tel: +356 21 441870
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal TESLASCAN lil GE Healthcare AS fit-22 ta' Mejju 1997.
English: It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas.
Maltese: Ir-rata ta' infużjoni hi bejn 2 u 3 ml kull minuta għall-ħruġ ta' immaġni tal-fwied u bejn 4 u 6 ml kull minuta għall-ħruġ ta' immaġni tal-frixa.
English: The medicinal product is for single intravenous use only as repeated dosing has not been studied.
Maltese: B'hekk tidher id-differenza bejn it-tessut normali u t-tessut anormali.
English: Mangafodipir trisodium is metabolised (dephosphorylated) and manganese ions are released from the mangafodipir by exchange with plasma zinc (mainly) after intravenous administration.
Maltese: Hekk kif tiġi injettata lmediċina, il-manganiż jinħeles u jiġi assorbit mit-tessut normali tal-fwied u tal-frixa b'rata ikbar milli miċ-ċelloli tal-kankru.
English: GE Healthcare A/S Huginsvej 8
Maltese: L-EPAR sħiħ dwar TESLASCAN jista' jinstab hawnhekk.
English: Mangafodipir is a chelate containing the metal manganese - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand fodipir (dipyridoxyl diphosphate).
Maltese: Il-pazjenti kellhom bejn waħda u ħames leżjonijiet fil-fwied li diġà kienu nstabu bl-MRI, bl-ultrasound, jew bittomografija kompjuterizzata (CT).
English: TESLASCAN 0.01 mmol/ml solution for infusion.
Maltese: Il-manganiż jirreaġixxi mal-molekoli ta' l-ilma.
English: Oy GE Healthcare Bio-Sciences Ab Kuortaneenkatu 2
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta medika.
English: H-2040 BUDAÖRS Tel. + 36 23 410 410
Maltese: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
English: 9 to < 16 16 to 23 > 23 to 34
Maltese: 9 sa < 16 16 sa 23 >23 sa 34
English: Dimethylacetamide Macrogol 400.
Maltese: Dimethylacetamide Makrogol 400.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - 2D BARCODE 2D barcode li għandu l-identifikatur uniku inkluż.
English: Not relevant
Maltese: Mhux rilevanti.
English: Vials: 3 years
Maltese: Kunjetti: 3 snin
English: Ventricular extrasystoles Bradycardia
Maltese: Ekstrasistoli ventrikulari Bradicardija
English: The active substance is busulfan.
Maltese: Is-sustanza attiva hi busulfan.
English: Creatinine elevated
Maltese: Kreatinina elevata
English: The 2-year OS rate was 61.9% (95%CI, 51.1-72.7%)].
Maltese: Ir-rata OS ta' sentejn kienet ta' 61.9% (95%CI, 51.1-72.7%)].
English: Paediatric population (0 to 17 years)
Maltese: Popolazzjoni pedjatrika (minn 0 sa 17-il sena)
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent
Maltese: • Kwantità ta' dilwent: ( A ml ta' Busilvex) x (10) = B ml tad-dilwent
English: Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
Maltese: Data tal-ewwel awtorizzazzjoni : 09 ta' Lulju 2003 Data tal-aħħar tiġdid: 08 ta' Lulju 2008
English: Pharmacokinetics in adults
Maltese: Farmakokinetika f'adulti
English: Anxiety Depression Insomnia
Maltese: Ansjetà Depressjoni Insomnja
English: Concentrate 4 vials of 10ml.
Maltese: 4 kunjetti ta' 10ml.
English: Rash Pruritis Alopecia
Maltese: Raxx Prurite Alopeċija
English: Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Maltese: Il-volum terminali tad-distribuzzjoni Vz kienet bejn 0.62 u 0.85 l/kg.
English: Infections.
Maltese: Infezzjonijiet.
English: Busulfan can impair fertility.
Maltese: Busulfan jista' jfixkel il-fertilità.
English: The terminal half life ranged from 2.26 to 2.52 h.
Maltese: In-nofs ħajja terminali kienet mifruxa minn 2.26 sa 2.52 h.
English: HVOD occurred in: 8.2% (5/61) allogeneic patients (fatal in 2 patients) and 2.5% (1/42) of autologous patients.
Maltese: HVOD laqtet: 8.2% (5/61) tal-pazjenti alloġenejiċi ( 2 pazjenti kienu fatali) u 2.5% (1/42) tal-pazjenti awtologużi.
English: The terminal half-life ranged from 2.8 to 3.9 hours.
Maltese: In-nofs ħajja terminali kienet minn 2.8 sa 3.9 sigħat.
English: Busilvex dose (mg/kg)
Maltese: Doża Busilvex (mg/kg)
English: Total clearance in plasma ranged 2.25 - 2.74 ml/minute/kg.
Maltese: It-tneħħija totali fil-plażma kienet minn 2.25 sa 2.74 ml/minuta/kg.
English: Mild/moderate fever was reported in 76% of patients.
Maltese: Deni ħafif/moderat kien irrapportat f'76% tal-pazjenti.
English: The pharmacokinetics of Busilvex has been investigated.
Maltese: Il-farmakokinetiċi tal-Busilvex kienu investigati.
English: Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Maltese: Bilirubin elavat (n=3) u AST elevat (n=1) kienu wkoll osservati.
English: • Quantity of Busilvex:
Maltese: • Kwantità ta' Busilvex:
English: Multipack containing 8 (2 packs of 4) vials.
Maltese: Pakkett multiplu li fih 8 (2 pakketti ta' 4) kunjett.
English: Other infections were considered severe in 3% of patients.
Maltese: Infezzjonijiet oħra kienu meqjusa bħala severi fi 3% tal-pazjenti.
English: Busulfan was mutagenic in Salmonella typhimurium, Drosophila melanogaster and barley.
Maltese: Busulfan kien mutaġeniku f'Salmonella typhimurium, Drosophila melanogaster u x-xgħir.
English: Delirium Nervousness Hallucination Agitation
Maltese: Delirjum Nervożità Alluċinazzjoni Aġitazzjoni
English: Veno occlusive disease (VOD) was reported in 15% (4/27) and 7% (2/28) of the autologous and allogenic transplant respectively.
Maltese: Mard okklużżiv tal-vini (VOD) kien irrapportat f'15% (4/27) u 7% (2/28) tat-trapjant awtologuż u dak alloġenejiku rispettivament.
English: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Maltese: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex Franza
English: VOD was reported with a range between 3.9% and 15.4%.
Maltese: VOD kien irrappurtat b'medda ta' bejn 3.9% u 15.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/254/002
English: DMA decreases fertility in male and female rodents (see sections 4.6 and 5.3).
Maltese: DMA inaqqas ilfertilità tal-annimali gerriema maskili u femminili (ara sezzjonijiet 4.6 u 5.3).
English: Therefore all patients experienced profound cytopenia: leucopenia 96%, thrombocytopenia 94%, and anemia 88%.
Maltese: Għalhekk il-pazjenti kollha esperjenzaw ċitopenija profonda: lewkopenja 96%, tromboċitopenja 94%, u anemja 88%.
English: The other ingredients are dimethylacetamide and macrogol 400.
Maltese: - Is-sustanzi l-oħra huma dimethylacetamide u macrogol 400.
English: A total of 14 patients (50%) experienced a-GVHD.
Maltese: Total ta' 14-il pazjent (50%) mardu bil-a-GVHD.
English: In one article it was studied the role of busulfan in juvenile rats resulting in abnormal root development; a review of two cases of immunodeficiency disorders treated with busulfan and cyclophosphamide in which dental orthodontic treatment was provided; additional 2 case report of hypoplasia of permanent tooth germ is presented; one review assessed the long term effects of cytotoxic therapy concluding that tooth agenesis was more prevalent in patients treated with busulfan and cyclophosphamide; a study of 81 patients concluded that busulfan is as toxic as total body irradiation in causing disturbances in dental development; finally, a study of risk factors of tooth formation anomalies in paediatric cancers concluded that the high risk group of tooth agenesis was the subject with high dose chemotherapy under 4 years old.
Maltese: F' artikolu wieħed ġie studjat ir-rwol ta' busulfan f'firien minorenni li jirriżultaw fl-iżvilupp ta' għeruq anormali; reviżjoni ta' żewġ każijiet ta' disturbi ta' immunodefiċjenza kkurati b'Busulfan u cyclophosphamide fejn kien ġie pprovdut trattament ortodontiku dentali; ġew ippreżentati żewġ rapporti ta' każijiet addizzjonali ta' ipoplażja tal-mikrobu fis-snien permanenti; reviżjoni wieħed evalwa l-effetti fit-tul tat-terapija ċitotossika li kkonkluda li l-aġenesi fis-snien kien aktar prevalenti f'pazjenti kkurati b'busulfan u cyclophosphamide; studju ta' 81 pazjent ikkonkluda li busulfan hu tossiku daqs irradjazzjoni totali tal-ġisem fl-ikkawżar ta' disturbi fl-iżvilupp tas-snien; fl-aħħarnett, studju dwar fatturi ta' riskju ta' anomaliji fil-formazzjoni tas-snien f'kanċer pedjatriku ikkonkluda li lgrupp ta' riskju għoli ta' aġenesi fis-snien kien is-suġġett ma' kimoterapija b'doża għolja taħt 4 snin.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Maltese: Il-proċeduri kollha ta' trasferiment jirrikjedu osservanza stretta ta' tekniċi aseptiċi, preferabbilment barnuża tas-sigurtà vertikali bi fluss laminari.
English: The most frequent infectious adverse reactions were Cytomegalovirus (CMV) reactivation [range: 30.7% - 80.0%], Epstein-Barr Virus (EBV) reactivation [range: 2.3% - 61%], bacterial infections [range: 32.0% - 38.9%] and viral infections [range: 1.3% - 17.2%].
Maltese: 0%], attivazzjoni mill-ġdid ta' Epstein-Barr Virus (EBV) [medda: 2.3%61%], infezzjonijiet batterjali [medda: 32.0% - 38.9% u infezzjonijiet virali [medda: 1.3% - 17.2%].
English: Busilvex in combination with cyclophosphamide:
Maltese: Busilvex flimkien ma' cyclophosphamide:
English: Nervous system: confusion, nervous system disorders.
Maltese: Sistema nervuża: konfużjoni, disturbi fis-sistema nervuża.
English: Invasive fungal infection
Maltese: Infezzjoni fungali invażiva
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Maltese: Anemja (emoglobina<8.0 g/d) irriżultat f'100% tal-pazjenti.
English: Pharmacokinetic/pharmacodynamic relationships:
Maltese: Relazzjonijiet farmakokinetiċi/farmakodinamiċi:
English: The incidence of a-GVHD grades I-II was 46.4% (13/28), while the incidence of grade III-IV was 3.6% (1/28).
Maltese: L-inċidenza tal-gradi ta' a-GVHD I-II kienu 46.4% (13/28), waqt li l-inċidenza ta' grad III-IV kien ta' 3.6% (1/28).
English: A total of 11 patients (18%) experienced a-GVHD.
Maltese: Total ta' 11-il pazjent (18%) mardu bil-a-GVHD.
English: However, caution is recommended (see sections 4.8 and 5.2).
Maltese: Imma tkun ħaġa għaqlija li wieħed joqgħod attent (ara sezzjonijiet 4.8 u 5.2).
English: Six of 103 patients (6%) experienced HVOD.
Maltese: Sitta minn 103 pazjent (6%) mardu bil-HVOD.
English: Busilvex in combination with fludarabine (FB) In adults
Maltese: Busilvex flimkien ma' fludarabine (FB) Fl-adulti
English: D: dose of Busilvex (see SPC section 4.2)
Maltese: D: doża ta' Busilvex (ara sezzjoni 4.2)
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Maltese: Id-dejta dwar l-inċidenza ta' mard akut tat-trapjant kontra r-riċevitur (a-GVHD) inġabar fi studju (alloġenejiku) (n=61) OMC-BUS-4.
English: Low inter (CV=21%) and intra (CV=12%) patient variability on busulfan exposure was demonstrated through a population pharmacokinetic analysis, performed on 102 patients.
Maltese: Varjabilità baxxa inter (CV=21%) u intra (CV=12%) fil-pazjenti dwar esponiment għal-busulfan intwera permezz ta' analiżi farmakokinetika tal-popolazzjoni, li sar fuq 102 pazjent.
English: Busilvex is available in multipacks comprising 2 packs, each containing 4 vials.
Maltese: Busilvex huwa disponibbli f'pakketti multipli li fihom 2 pakketti, kull wieħed fih 4 kunjetti.
English: A continuous variation of clearance ranging from 2.49 to 3.92 ml/minute/kg has been established in children from < 6 months up to 17 years old.
Maltese: Kien hemm varjazzjoni kontinwa ta' tkeċċija minn 2.49 sa 3.92 ml/minuta/kg fi tfal minn <6 xhur sa 17-il sena.
English: Busulfan is mutagenic and clastogenic.
Maltese: Busulfan hu mutaġeniku u klastoġeniku.
English: Nervous system: insomnia, anxiety, dizziness, and depression.
Maltese: Sistema nervuża: insomnja, ansjetà, stordament, u dipressjoni.
English: Adjusted ideal body weight (AIBW) is calculated as follows: AIBW= IBW+0.25x (actual body weight - IBW).
Maltese: Piż aġġustat ideali tal-ġisem (AIBW) huwa kkalkulat kif ġej: AIBW=IBW+0.25x (piż attwali tal-ġisem - IBW).
English: Acute GVHD was rated as serious in 3 patients.
Maltese: GVHD akuta kienet ikklasifikata bħala serja fi 3 pazjenti.
English: MM/YYYY
Maltese: Kesħa
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Pierre Fabre Médicament
English: Total dose of busulfan per patient was between 6.4 mg/kg and 9.6 mg/kg.
Maltese: Id-doża totali ta' busulfan għal kull pazjent kienet ta' 6.4 mg/kg u 9.6 mg/kg.
English: Busulfan induced chromosomal aberrations in vitro (rodent and human cell) and in vivo (rodents and humans).
Maltese: Busulfan ikkaġuna aberrazzjonijiet kromosomali in vitro (f'ċellula ta' annimali gerriema u umana) u in vivo (annimali gerriema u bnedmin).
English: Grade 3 elevated transaminases were reported in 24% of patients.
Maltese: Transaminasi elevati grad 3 kien irrapportat f'24% tal-pazjenti.
English: Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Maltese: Anomaliji oħra frekwenti jinkludu palat mixquq, anasarka, anomaliji skeletali tal-vertibri u tal-kustilji.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jista' jolqot sa 1 f'100 persuna):
English: Pulmonary infection
Maltese: Infezzjoni pulmonari
English: IBW women (kg) = 45 + 0.91x (height in cm-152).
Maltese: IBW irġiel (kg) = 50 + 0.91x (tul f'ċentimetri-152); IBW nisa (kg) = 45 + 0.91x (tul f'ċentimetri-152).
English: Preparation of Busilvex
Maltese: Preparazzjoni tal-Busilvex
English: Platelet engraftment occurred at a median of 9 (range, 1-16) days after allo-HCT.
Maltese: L-engraftment tal-plejtlits seħħ f'medjan ta' 9 (medda, 1-16) ijiem wara allo-HCT.
English: PRESENTATION
Maltese: Astenja