FrancophonIA/ELRC3.0 huggingface dataset:
English: Live non-pathogenic vaccine to reduce diarrhoea, faecal shedding and intestinal colonization associated with F4-positive enterotoxigenic Escherichia coli in pigs.
Maltese: Tilqima ħajja mhux patoġenika biex tnaqqas id-dijarea, tixrid mill-ippurgar u kolonizzazzjoni intestinali assoċjata ma' Escherichia coli enterotossiġenika pożittiva għal F4 fil-ħnieżer.
English: - reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.
Maltese: - tnaqqas il-kolonizzazzjoni tal-iljum u tixrid mill-ippurgar ta' Escherichia coli enterotossiġenika pożittiva għal F4 minn ħnieżer infettati.
English: Administer a single 2 ml dose orally to pigs (from 18 days of age), irrespective of body weight.
Maltese: Agħti doża waħda ta' 2 ml mill-ħalq lill-ħnieżer (mill-età ta' 18-il ġurnata), irrespettivament mill-piż tal-ġisem.
English: In driniking water use.
Maltese: Ħallat sew u uża immedjatament.
English: The reconstituted vaccine is a transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
Maltese: It-tilqima rikostitwita hija sospensjoni bajda-safranija trasparenti għal opaka skont il-volum tal-ilma użat għad-dilwizzjoni.
English: EMA/121020/2014 EMEA/H/C/002348
Maltese: EMEA/H/C/003890
English: DuoResp Spiromax is a ‘hybrid medicine'.
Maltese: DuoResp Spiromax huwa ‘mediċina ibrida'.
English: The full EPAR and risk management plan summary for DuoResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal DuoResp Spiromax jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Formoterol is a long-acting beta-2 agonist.
Maltese: Il-formoterol huwa agonist beta-2 li jaħdem fit-tul.
English: The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.
Maltese: Il-mediċina ta' referenza għal DuoResp Spiromax hija Symbicort Turbohaler.
English: The European Commission granted a marketing authorisation valid throughout the European Union for DuoResp Spiromax on 28 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal DuoResp Spiromax fit-28 ta' April 2014.
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Maltese: mikrogramma (160 mikrogramma ta' budesonide u 4.5 mikrogramma ta' formoterol) jista' jintuża għall-kura regolari tal-ażżma u meta meħtieġa biex ittaffi.
English: The higher strength, DuoResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Maltese: Hija tista' tintuża wkoll għall-kura ta' COPD. L-ogħla qawwa, DuoResp Spiromax 320/9 mikrogrammi (320 mikrogramma ta' budesonide u 9 mikrogrammi ta' formoterol), tista' tintuża biss għall-kura regolari tal-ażżma u għall-kura tas-COPD.
English: DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Maltese: DuoResp Spiromax huwa mediċina li fiha s-sustanzi attivi l-budesonide u l-formoterol.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that DuoResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li DuoResp Spiromax 160/4.5 mikrogramma u 320/9 mikrogramma wera li għandu kwalità komparabbli u huwa bijoekwivalenti għall-qawwiet korrispondenti ta' Symbicort Turbohaler.
English: Other information about DuoResp Spiromax
Maltese: Informazzjoni oħra dwar DuoResp Spiromax
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but DuoResp Spiromax is given using a different inhaler.
Maltese: Dan ifisser li huwa simili għal 'mediċina ta' referenza' li fiha l-istess sustanzi attivi, iżda DuoResp Spiromax jingħata bl-użu ta' inalatur differenti.
English: DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Maltese: DuoResp Spiromax jintuża wkoll biex itaffi s-sintomi tal-marda pulmonari ostruttiva kronika severa (COPD- chronic obstructive pulmonary disease) fl-adulti li kellhom aggravamenti (feġġiet) tal-marda fil-passat minkejja kura regolari.
English: A risk management plan has been developed to ensure that DuoResp Spiromax is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li DuoResp Spiromax jintuża bl-aktar mod sigur possibbli.
English: This is a summary of the European public assessment report (EPAR) for DuoResp Spiromax.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal DuoResp Spiromax.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Maltese: Il-budesonide jappartjeni għal grupp ta' mediċini anti-infjammatorji magħrufin bħala kortikosterojdi.
English: Because DuoResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li DuoResp Spiromax huwa mediċina ibrida u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: DuoResp Spiromax
Maltese: Kif jintuża DuoResp Spiromax?
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Maltese: Bħala terapija għat-taffija tal-ażżma, il-pazjenti jistgħu jieħdu 1 jew 2 inalazzjonijiet addizzjonali ta' DuoResp Spiromax 160/4.5 mikrogramma biss biex itaffu s-sintomi tagħhom.
English: Why is DuoResp Spiromax approved?
Maltese: Għaliex ġie approvat DuoResp Spiromax?
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Maltese: Dan jaħdem b'mod simili għal ormoni kortikosterojdi li jseħħu b'mod naturali, billi jnaqqas l-attività tas-sistema immunitarja billi jintrabat ma' riċetturi f'diversi tipi ta' ċelloli immunitarji.
English: Studies in patients have been limited to tests to determine that DuoResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Maltese: L-istudji f'pazjenti ġew limitati għal testijiet biex jiddeterminaw li DuoResp Spiromax huwa bijoekwivalenti għall-mediċina ta' referenza, Symbicort Turbohaler.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Maltese: Jista' jintuża f'pazjenti li lmarda tagħhom ma tkunx ikkontrollata b'mod adegwat permezz ta' kura b'mediċini oħrajn għall-ażżma li jissejħu kortikosterojdi u ‘agonisti tal-beta-2 li jaħdmu għal żmien qasir' li jittieħdu man-nifs, jew f'pazjenti li l-marda tagħhom hija kkontrollata b'mod adegwat permezz ta' kura bil-kortikosterojdi u ‘agonisti tal-beta-2 li jaħdmu fit-tul' li jittieħdu man-nifs.
English: What are the benefits and risks of DuoResp Spiromax?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' DuoResp Spiromax?
English: How has DuoResp Spiromax been studied?
Maltese: Kif ġie studjat DuoResp Spiromax?
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-proċedura ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: Arquiparque - Miraflores 1495-131 Algés PORTUGAL
Maltese: Arquiparque - Miraflores 1495-131 Algés
English: Kifissias 266, 152 32 Halandri, Athens GREECE
Maltese: 152 32 Halandri, Athens GREECE
English: Stonemasons Way, Rathfarnham, Dublin 16
Maltese: Way, Rathfarnham, Dublin 16
English: GlaxoSmithKline 100, route de Versailles78163 Marly-le-Roi Cedex FRANCE
Maltese: Laboratoire GlaxoSmithKline 100, route de Versailles - 78163 Marly-le-Roi Cedex FRANCE
English: Glaxo Smith Kline B.V. Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
Maltese: Huis ter Heideweg 62 3705 LZ ZEIST NETHERLANDS
English: GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana
Maltese: GSK d.o.o., Ljubljana Cvetkova ulica 29SI-1000 Ljubljana SLOVENIA
English: SLOVENIA
Maltese: Slovenja
English: Curocef 750 mgTrockenstechampull en
Maltese: Curocef 750 mgTrockenstechampullen
English: Nykaer 68, 2605 Broendby DENMARK
Maltese: GlaxoSmithKline Pharma A/S Nykaer 68, 2605 Broendby DENMARK
English: GlaxoSmithKline Pharma GmbH, Albert SchweitzerGasse 6,
Maltese: GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, A-1140 Wien
English: GlaxoSmithKline Export Ltd. 980 Great West Road Brentford, Middlesex, TW8 9GS
Maltese: Ltd. 980 Great West Road Brentford, Middlesex, TW8 9GS UNITED KINGDOM
English: GlaxoSmithKline Kft. 1124 Bp, Csörsz u. 43.
Maltese: GlaxoSmithKline Kft. 1124
English: 1.5g/VIAL
Maltese: 1.5g/KUNJETT
English: 250mg/1ml or 250mg/2-5ml
Maltese: 250mg/1ml jew 250mg /2-5ml
English: 250mg/VIAL
Maltese: 250mg/KUNJETT
English: 250mg 2ml (intravenous) 250mg/1ml (intramuscular)
Maltese: 250mg/2ml (ġolvina) 250mg/1ml (ġol-muskolu)
English: Curocef 250 mgTrockenstechamupll en
Maltese: Curocef 250 mgTrockenstechamupllen 250mg Trab għall-Injezzjoni
English: Injection : 1.5g/15ml Infusion : 1.5g/15ml + 50ml or 100ml
Maltese: Injezzjoni : 1.5g/15ml Infużjoni : 1.5g/15ml + 50ml jew 100ml
English: 750mg/3ml or 750 mg/6 - 10 ml
Maltese: 750mg/3ml jew 750 mg/6 - 10 ml
English: Glaxo Group Ltd., Greenford, Middlesex UB6 0NN
Maltese: Glaxo Group Ltd., Greenford, Middlesex UB6 0NN UNITED KINGDOM
English: Glaxo Wellcome House Berkeley Avenue Greenford
Maltese: Glaxo Operations UK Limited Glaxo Wellcome House Berkeley Avenue Greenford
English: 750mg/VIAL
Maltese: 750mg/KUNJETT
English: 750mg/6ml (intravenous) 750mg/3ml (intramuscular)
Maltese: 750mg/6ml (ġol-vina) 750mg/3ml (ġol-muskolu)
English: GlaxoSmithKline Pharma A/S
Maltese: GlaxoSmithKline S.p.A.
English: Powder for suspension for Infusion
Maltese: Trab għal suspensjoni għall-Infużjoni
English: 1.5g Powder for Infusion Intravenous Use
Maltese: 1.5g Trab għall-Infużjoni
English: Powder for suspension for Injection
Maltese: Trab għal suspensjoni għall-Injezzjoni
English: 1.5g Powder for Injection Intravenous Use
Maltese: 1.5g Trab għall-Injezzjoni
English: Curocef 1500 mgTrockenstechampull en
Maltese: Curocef 1500 mgTrockenstechampullen 1.5g Trab għall-Injezzjoni jew għall-Infużjoni
English: Race/ethnicity
Maltese: Razza/etniċità
English: T½ (day)
Maltese: T½ (jum)
English: Studies B2202 (N=75) + C2201 (N=111)
Maltese: Studji B2202 (N=75) + C2201 (N=111)
English: Common (≥1/100 to <1/10)
Maltese: Komuni (≥1/100 to <1/10)
English: • Anxiety, irritability
Maltese: • Ansjetà, irritabbiltà
English: Cmax (copies/μg)
Maltese: Cmax (kopji/μg)
English: Educational programme
Maltese: Programm edukattiv
English: Store and transport below -120°C.
Maltese: Aħżen u ġorr taħt -120°C.
English: - Active uncontrolled infection.
Maltese: - Infezzjoni attiva mhux ikkontrollata.
English: Primary endpoint
Maltese: Endpoint primarju
English: AUC0-28d (copies/μg*day)
Maltese: AUC0-28d (kopji/μg*jum)
English: Overall response rate (ORR) (CR+PR)1, n (%) 95% CI
Maltese: Rata ta' rispons sħiħ (ORR) (CR+PR)1, n (%) 95% CI
English: • An antihistamine such as diphenhydramine.
Maltese: • Antiistamin bħal diphenhydramine.
English: Kymriah 1.2 x 10
Maltese: Fih 1.2 x 10
English: Test and checks
Maltese: Test u kontrolli
English: • Administer tocilizumab.
Maltese: • Agħti tocilizumab.
English: ORR was consistent across subgroups.
Maltese: L-ORR kien konsistenti fost is-sottogruppi.
English: Prior treatment with anti-CD19 therapy
Maltese: Trattament preċedenti b'terapija anti-CD19
English: Novartis Pharmaceutical Corporation 220 East Hanover Avenue Morris Plains
Maltese: East Hanover Avenue Morris Plains
English: Update reports:
Maltese: Rapporti aġġornati:
English: Updated reports: September 2019, November
Maltese: Settemrbu 2019, Novembru
English: Median (months) (95% CI)
Maltese: Medjan (xhur) (95% CI)
English: • The active substance of Kymriah is called tisagenlecleucel.
Maltese: • Is-sustanza attiva ta' Kymriah tissejjaħ tisagenlecleucel.
English: Abdominal compartment syndrome
Maltese: Sindrome kompartamentali addominali
English: Tmax (day)
Maltese: Tmax (jum)
English: Responding patients (CR/CRi)
Maltese: Pazjenti li rrispondew (CR/CRi)
English: Geometric mean (CV%), n
Maltese: Medja ġeometrika (CV%), n
English: CR or CRi with MRD negative bone marrow5,6, n (%) 95% CI
Maltese: CR jew CRi b'mudullun b'MRD negattiva5,6, n (%) 95% CI
English: • Failure of multiple organs
Maltese: • Insuffiċjenza ta' bosta organi
English: 9 months.
Maltese: 9 xhur.
English: Availability of tocilizumab and site qualification
Maltese: Disponibbiltà ta' tocilizumab u kwalifikazzjoni tas-sit
English: Dispersion for infusion 10 mL - 50 mL per bag.
Maltese: Dispersjoni għall-infużjoni 10 mL - 50 mL kull borża.
English: Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Maltese: Pazjenti sjeropożittivi għall-virus tal-epatite B (HBV), għall-virus tal-epatite Ċ (HCV), jew għall-virus ta' immunodefiċjenza umana (HIV)
English: Acute lymphoblastic leukaemia (ALL)
Maltese: Lewkimja limfoblastika akuta (ALL)
English: Tumour lysis syndrome (TLS)
Maltese: Sindrome ta' liżi ta' tumur (TLS)
English: Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10-30 mL (50 mL bags) or 30-50 mL (250 mL bags) cell dispersion.
Maltese: Borża bl-infużjoni ethylene vinyl acetate (EVA) b'tubi polyvinyl chloride (PVC) u interkonnettur luer spike magħluq b'tapp luer-lock li fiha jew 10-30 mL (boroż tal-50 mL) jew bi 30-50 mL (boroż ta' 250 mL) dispersjoni taċ-ċellula.
English: June 2022
Maltese: Ġunju 2022
English: Peripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, neuropathy peripheral, hyperaesthesia and hypoaesthesia.
Maltese: In-newropatija periferali tinkludi paraesteżija, newropatija periferali sensorjali, newropatija periferali, iperesteżija u ipoesteżija.
English: Disease status (%) Primary refractory1
Maltese: Qagħda tal-marda (%) Refrattorja primarja1
English: Each bag contains 10 mL to 50 mL of dispersion.
Maltese: Kull borża fiha 10 mL sa 50 mL dispersjoni.
English: Date of birth: {DD MMM YYYY} SEC:
Maltese: Data tat-twelid: {JJ XXX SSSS} SEC:
English: Secondary malignancies
Maltese: Malinnijiet sekondarji
English: Duration of remission (DOR)7
Maltese: Dewmien tar-remissjoni (DOR)7
English: There was no evidence for preferential integration near genes of concern or preferential outgrowth of cells harbouring integration sites of concern.
Maltese: M'hemm ebda evidenza ta' integrazzjoni preferenzjali qrib ġeni inkwetanti jew tkabbir preferenzjali ta' ċelluli li jħaddnu siti ta' integrazzjoni inkwetanti.
English: Limit to a maximum total of 4 tocilizumab doses.
Maltese: Illimita għal total massimu ta' 4 dożi ta' tocilizumab.
English: This medicinal product contains 10 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL.
Maltese: Dan il-prodott mediċinali fih 10 mg dextran 40 u 82.5 mg dimethyl sulfoxide (DMS) f'kull mL.
English: cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Maltese: ċelluli dispersjoni għall-infużjoni tisagenlecleucel (CAR+ ċelluli T vijabbli)
English: Non-responding patients (SD/PD/Unknown) N=58
Maltese: Pazjenti li ma rrispondewx (SD/PD/Mhux magħruf) N=58
English: Table 2 Adverse drug reactions observed in clinical studies
Maltese: Tabella 2 Reazzjonijiet avversi tal-mediċina osservati waqt studji kliniċi
English: Median [min;max], n 289 [18.0; 693], 35 57.0 [16.0; 374], 48
Maltese: Medjan [min;max], n 289 [18.0; 693], 35 57.0 [16.0; 374], 48
English: Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <10 years ≥10 years and <18 years ≥18 years
Maltese: Medja (devjazzjoni standard) Medjan (minimu - massimu) Kategorija tal-età (snin) - n (%) <10 snin ≥10 snin u <18-il sena ≥18-il sena
English: Infections and infestationsa)
Maltese: Infezzjonijiet u infestazzjonijieta)
English: Adverse drug reaction (MedDRA system organ class)
Maltese: Reazzjoni avversa tal-mediċina (issistema talklassifika talorganu MedDRA)
English: Table 7 Cellular kinetic parameters of tisagenlecleucel in paediatric and young adult r/r B-cell ALL (Studies B2202 and B2205J)
Maltese: Tabella 7 Il-parametri tal-kinetika ċellulari ta' tisagenlecleucel fost pazjenti pedjatriċi u adulti żgħażagħ b'ALL b'r/r taċ-ċellula B (Studji B2202 u B2205J)
English: In Studies B2202 and B2205J there were 79.8% Caucasian, 7.7% Asian and 12.5% other ethnic patients.
Maltese: Fl-Istudji B2202 u B2205J kien hemm 79.8% talpazjenti Kawkażjatiċi, 7.7% tal-pazjenti Ażjatiċi u 12.5% tal-pazjenti ta' etniċità oħra.
English: Median [min;max], n 9.83 [5.78; 16.8], 35 8.86 [3.04; 27.7], 51
Maltese: Medjan [min;max], n 9.83 [5.78; 16.8], 35 8.86 [3.04; 27.7], 51
English: Not reached (10.0, NE4) Not reached (10.0, NE4)
Maltese: Mhux milħuqa (10.0, NE4)
English: In Study C2201 there were 88% Caucasian, 5% Asian, 4% Black or African American patients, and 3 patients (3%) of unknown race.
Maltese: Fl-Istudju C2201 kien hemm 88% tal-pazjenti Kawkażjatiċi, 5% tal-pazjenti Suwed jew Amerikani Afrikani, u 3 pazjenti (3%) ta' razza mhux magħrufa.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: not yet assigned
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi oħrajn, kodiċi ATC: mhux assenjat
English: Hypogammaglobulinaemia
Maltese: Ipogammaglobulinemija
English: Final CSR: August 2023
Maltese: CSR aħħari: Awwissu 2023
English: They should be monitored life-long for secondary malignancies.
Maltese: Għandhom ikunu mmonitorati tul ħajjithom għal malinnijiet sekondarji.
English: Sodium chloride Human albumin solution Dextran 40 for injection Dimethylsulfoxide Sodium gluconate Sodium acetate
Maltese: Sodium chloride Soluzzjoni bl-albumina umana Dextran 40 għall-injezzjoni Dimethylsulfoxide Sodium gluconate Sodium acetate
English: NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion tisagenlecleucel (CAR+ viable T cells)
Maltese: Kymriah 1.2 x 106 - 6 x 108 ċelluli dispersjoni għall-infużjoni tisagenlecleucel (CAR+ ċelluli T vijabbli)
English: The scatter plots of cellular kinetic parameters versus age (22-76 years) revealed no relevant relationship between cellular kinetic parameters (AUC0-28d and Cmax) with age.
Maltese: Id-dijagrammi bil-firxa tal-parametri tal-kinetika ċellulari kontra l-età (22-76 sena) ma wrew l-ebda relazzjoni relevanti bejn il-parametri tal-kinetika ċellulari (AUC0-28d u Cmax) mal-età.
English: Abdominal distension Ascites
Maltese: Distensjoni addominali
English: Epistaxis Lung infiltration
Maltese: Epistassi Infiltrazzjoni fil-pulmun
English: Content of dextran 40 and dimethyl sulfoxide (DMSO)
Maltese: Kontenut ta' dextran 40 u dimethyl sulfoxide (DMSO)
English: Infused N=111 n (%)
Maltese: Mogħtija l-infużjoni N=111 n (%)
English: Arrhythmia includes atrial fibrillation and supraventricular tachycardia.
Maltese: L-arritmija tinkludi fibrillazzjoni atrijali u takikardija sopraventrikulari.
English: See section 2, “Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40”.
Maltese: Ara sezzjoni 2, “Kymriah fih is-sodju, dimethylsulfoxide (DMSO) u dextran 40”.
English: Age (years) Mean (standard deviation) Median (minimum - maximum) Age category (years) - n (%) <65 years ≥65 years Sex - n (%) Male Female Prior haematopoietic stem cell transplant (SCT) - n (%) No Yes Stage III/IV disease at study entry - n (%) No Yes Number of prior lines of antineoplastic therapy - n (%)
Maltese: Età (snin) Medja (devjazzjoni standard) Medjan (minimu - massimu) Kategorija tal-età (snin) - n (%) <65 sena ≥65 sena Sess - n (%) Raġel Mara Qabel it-trapjant taċ-ċellula steminali ematopoetika (SCT) - n (%) Le Iva Marda fi stadju III/IV mas-sħubija flistudju - n (%) Le Iva Għadd ta' linji ta' terapija antineoplastika mogħtija qabel - n (%)
English: Median [min;max], n 170 [17.8; 617], 80 28.8 [13.9; 376], 11 ‡A total of 5 patients had an early Tmax (<1 days), the next lowest Tmax occurs at 5.7 days.
Maltese: Medjan [min;max], n 170 [17.8; 617], 80 28.8 [13.9; 3760], 11 ‡Total ta'5 pazjenti kellhom Tmax bikrija (<1 jiem), l-aktar Tmax baxx li jmiss seħħ fil-5.7 jiem.
English: Sodium and potassium content
Maltese: Kontenut ta' sodju u potassium
English: Dispersion for infusion.
Maltese: Mhux applikabbli.
English: • You have had hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
Maltese: • Jekk kellek epatite B, epatite C jew infezzjoni bil-virus tal-immunodefiċjenza umana (HIV).
English: The overall incidence (all grades) was 54% (unspecified 44%, bacterial 10%, fungal 10% and viral 8%) (see section 4.4).
Maltese: L-inċidenza ġenerali (il-gradi kollha) kienet ta' 54% (mhux speċifikata 44%, batterika 10%, fungali 10% u virali 8%) (ara sezzjoni 4.4).
English: Enrolled N=92 n (%)
Maltese: Imsieħba N=92 n (%)
English: Enrolled N=165 n (%)
Maltese: Imsieħba N=165 n (%)
English: In Study B2202, 43% female and 57% male patients and in Study C2201 39% female and 61% male patients received Kymriah.
Maltese: Fl-Istudju B2202, 43% tal-pazjenti nisa u 57% tal-pazjenti rġiel u flIstudju C2201 39% tal-pazjenti nisa u 61% tal-pazjenti rġiel ingħataw Kymriah.
English: In the ongoing clinical study in DLBCL (N=111), cytokine release syndrome was reported in 58% of patients, (22% with Grade 3 or 4).
Maltese: Fl-istudju kliniku kontinwu DLBCL (N=111), is-sindrome ta' rilaxx taċ-ċitokini kienet irrappurtata fi 58% tal-pazjenti, (22% bi Grad 3 jew 4).
English: Rashp)
Maltese: Raxxp)
English: - Patient weight less than 30 kg: 12 mg/kg intravenously over 1 hour - Patient weight ≥30 kg: 8 mg/kg intravenously over 1 hour (maximum dose 800 mg)
Maltese: - Pazjent li jiżen anqas minn 30 kg: 12 mg/kg fil-vina fuq medda ta' siegħa - Pazjent li jiżen ≥30 kg: 8 mg/kg fil-vina fuq medda ta' siegħa (doża massima ta' 800 mg)
English: • You have an infection.
Maltese: • Għandek infezzjoni.
English: • after treatment while the immune system is recovering.
Maltese: • wara t-trattament waqt li s-sistema immuni tiegħek qed tirkupra.
English: Blood fibrinogen decreased Serum ferritin increased Blood alkaline phosphatase increased Fibrin D dimer increased Prothrombin time prolonged a)
Maltese: Tnaqqis tal-fibrinoġenu fid-demm Żieda tal-ferritin fis-serum Żieda tal-fosfatażi alkalina fid-demm Żieda tal-fibrin D-dimer Ħin tal-protrombina mtawwal a)
English: Disseminated intravascular coagulation
Maltese: Koagulazzjoni intravaskulari mifruxa Koagulopatija
English: Also contains: glucose, sodium chloride, human albumin solution, dextran 40 for injection, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, water for injections.
Maltese: Fih ukoll: glucose, sodium chloride, soluzzjoni bl-albumina umana, dextran 40 għall-injezzjoni, dimethylsulfoxide, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium-N-acetyltryptophanate, sodium caprylate, aluminium, ilma għall-injezzjonijiet.