FrancophonIA/ELRC3.0 huggingface dataset:
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Maltese: • Meta tinjetta f'CVAD jista' jkollok bżonn tuża siringa sterili tal-plastik ta' 10 ml biex tiġbed issoluzzjoni rrikostitwita.
English: This glycoprotein has the same structure as human factor VIII when activated, and posttranslational modifications that are similar to those of the plasma-derived molecule.
Maltese: Din il-glikoproteina għandha l-istess struttura tal-fattur VIII tal-bniedem meta tiġi attivata, u modifikazzjonijiet post-traslazzjonali li jixbhu lil dawk tal-molekula derivata mill-plażma.
English: • Use a clean and germ free (aseptic) technique.
Maltese: • Uża teknika nadifa u mingħajr mikrobi (asettika).
English: Syringe cap
Maltese: Tapp tas-siringa
English: <6 years) PTP
Maltese: Tfal żgħar <6 snin) PTP
English: During clinical trial in PUPs, 21 patients were treated with ITI and 18 (86%) patients completed ITI with a negative inhibitor test result.
Maltese: Data dwar Ikkaġunar ta' Tolleranza Immuni (ITI, Immune Tolerance Induction) inġabret f'pazjenti b'emofilja A li kienu żviluppaw inibituri għall-fattur VIII. Matul il-prova klinika fil-PUPs, 21 pazjent kienu ttrattati b'ITI u 18-il pazjent (86%) temmew ITI b'riżultat negattiv għat-test tal-inibitur.
English: Contusion
Maltese: Impedituri
English: administration of 50 IU/kg
Maltese: BMI ≥35 kg/m2.
English: • room temperature (≤ 30°C) for a single period no longer than 9 months or
Maltese: • temperatura tal-kamra (≤ 30°C) għal perijodu wieħed ta' mhux aktar minn 9 xhur jew
English: An increase in dose may be required for underweight patients (BMI <18.5 kg/m2) and a decrease in dose may be required for obese patients (BMI ≥30 kg/m2), but there is insufficient data to recommend specific dose adjustments, see section 5.2.
Maltese: Jista' jkun hemm bżonn ta' żieda fid-doża f'pazjenti li huma neqsin millpiż (BMI <18.5 kg/m2) u jista' jkun hemm bżonn ta' tnaqqis fid-doża f'pazjenti obeżi (BMI ≥30 kg/m2), iżda m'hemmx biżżejjed dejta biex jiġu rrakkomandati aġġustamenti speċifiċi fid-doża, ara sezzjoni 5
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Maltese: Il-kumpless magħmul minn fattur VIII/fattur von Willebrand jikkonsisti f'żewġ molekuli (il-fattur VIII u l-fattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: The single dose pharmacokinetic parameters of NovoEight are listed in Table 4 for the one-stage clotting assay and in Table 5 for the chromogenic assay.
Maltese: Il-parametri farmakokinetiċi ta' doża waħda ta' NovoEight huma elenkati f'Tabella 4 għall-assaġġ ta' tagħqid fi stadju wieħed u f'Tabella 5 għall-assaġġ kromoġeniku.
English: PC: SN:
Maltese: Il-pakkett fih:
English: t½ (h)
Maltese: • uġigħ ta' ras
English: You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters.
Maltese: Inti se jkollok bżonn ukoll sett tal-infużjoni (pajp irqiq u labra butterfly), mselħiet sterili bl-alkoħol, gareż u stikk.
English: NovoEight can be used for all age groups.
Maltese: NovoEight jista' jintuża fil-gruppi kollha ta' età.
English: Keep reconstituted NovoEight solution out of direct light.
Maltese: Tesponix is-soluzzjoni rrikostitwita ta' NovoEight għal dawl dirett.
English: Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Maltese: Meta tinjetta NovoEight permezz ta' konnetturi ta' mingħajr labra għal kateters fil-vina (IV)
English: Plunger rod
Maltese: Poplazzjoni pedjatrika
English: <12 years) PTP
Maltese: Tfal ikbar <12-il sena) PTP
English: How to store NovoEight
Maltese: X'fih NovoEight
English: The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay.
Maltese: Il-qawwa (IU) tiġi stabbilita bl-użu tal-assaġġ kromoġeniku tal-Farmakopea Ewropea (Ph. Eur).
English: A single dose pharmacokinetic trial (50 IU/kg) was performed in 35 haemophilia patients (≥18 years of age) in different BMI categories.
Maltese: IU/kg) saret f'35 pazjent bl-emofilja (età ≥18-il sena) f'kategoriji differenti ta' Indiċi tal-Massa tal-Ġisem (BMI - Body Mass Index).
English: NovoEight 2000 IU powder for solution for injection turoctocog alfa
Maltese: IU trab għal soluzzjoni għall-injezzjoni turoctocog alfa
English: • fast heartbeat
Maltese: • attakk tal-qalb
English: The pharmacokinetic parameters were comparable between paediatric patients below 6 years of age and the paediatric patients from 6 to below 12 years of age.
Maltese: Il-parametri farmakokinetiċi kienu kumparabbli bejn il-pazjenti pedjatriċi taħt l-età ta' 6 snin u l-pazjenti pedjatriċi mill-età ta' 6 snin sa taħt it-12-il sena.
English: NovoEight 3000 IU EU/1/13/888/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/888/006
English: Rash, rash erythematous
Maltese: Kura skont il-bżonn
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of bleeding tendencies.
Maltese: Permezz ta' terapija ta' sostituzzjoni l-livelli tal-fattur VIII fil-plażma jiżdiedu, b'hekk issir possibbli korrezzjoni temporanja tad-defiċjenza fil-fattur u korrezzjoni tad-tendenzi għall-fsada.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Maltese: L-emofilja A hija disturb ereditarju ta' tagħqid tad-demm marbut mas-sess tal-persuna minħabba livelli mnaqqsa ta' fattur VIII:C u twassal għal fsada kbira fil-ġogi, fil-muskoli, jew fl-organi interni, jew b'mod spontanju jew minħabba trawma aċċidentali jew kirurġika.
English: NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni turoctocog alfa (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA))
English: • chest tightness
Maltese: Kif jingħata NovoEight
English: L) Unscrew the vial adapter with the vial.
Maltese: L) Ħoll l-adapter tal-kunjett minn mal-kunjett.
English: System Organ Class Frequencya in PTPs
Maltese: Frekwenzaa f'PTPs Frekwenzaa f'PUPs Reazzjoni avversa
English: Very commonb
Maltese: Mhux komunib
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml normal human plasma.
Maltese: Unità Internazzjonali waħda (IU) ta' attività tal-fattur VIII hija ekwivalenti għal dik il-kwantità ta' fattur VIII f'ml wieħed ta' plażma normali tal-bniedem.
English: 1 vial with NovoEight powder 1 vial adapter
Maltese: • kunjett wieħed bit-trab NovoEight
English: Remove the protective cap from the vial adapter.
Maltese: Neħħi l-karta protettiva mill-adapter tal-kunjett.
English: d Hepatic enzymes increased include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and bilirubin.
Maltese: Meta jiġi infuż f'pazjent bl-emofilja, il-fattur VIII jintrabat mal-Fattur von Willebrand endoġeniku fiċ-ċirkulazzjoni tal-pazjent.
English: Each powder vial contains nominally 3000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: IU/ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: The most frequently reported adverse reaction was Factor VIII inhibition, see section 4.4.
Maltese: Ir-reazzjoni avversa rrappurtata b'mod laktar frekwenti kienet l-inibizzjoni ta' Fattur VIII, ara sezzjoni 4.4.
English: After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: Wara r-rikostituzzjoni NovoEight fih madwar 375 IU/ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection
Maltese: Trombożi fl-apparat a Ikkalkulata abbażi tan-numru totali ta' pazjenti uniċi fil-provi kliniċi kollha (301).li minnhom 242 kienu pazjenti kkurati preċedentement (PTPs) u 60 kienu pazjenti li ma kinux ikkurati preċedentement (PUPs) b Il-frekwenza hija bbażata fuq studji magħmula fuq il-prodotti kollha ta' FVIII li inkludew pazjenti b'emofilja A severa c Reazzjonijiet fis-sit tal-injezzjoni jinkludu eritema fis-sit tal-injezzjoni, estravażjoni fis-sit tal-injezzjoni u ħakk fis-sit tal-injezzjoni d Żieda fl-enzimi tal-fwied jinkludu alanine aminotransferase, aspartate aminotransferase, gammaglutamyltransferase u bilirubin.
English: Haemarthrosis, Muscle haemorrhage
Maltese: Emartrożi, emorraġija filmuskoli
English: Cough
Maltese: Kamin
English: FVIII inhibition
Maltese: Disturbi psikjatriċi
English: Pre-filled syringe with solvent
Maltese: Siringa mimlija għal-lest bis-solvent
English: Table 7 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaChromogenic assay - Mean (SD)
Maltese: IU/kg) skont il-klassijiet talBMIa - assaġġ kromoġeniku- Medja (SD)
English: GENERAL CLASSIFICATION FOR SUPPLY
Maltese: Obeżità klassi I
English: 6.3 Shelf life
Maltese: Tarf wiesa
English: Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Maltese: Tabella 4 Parametri farmakokinetiċi ta' doża waħda ta' NovoEight (50
English: NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Maltese: IU trab u solvent għal soluzzjoni għall-injezzjoni turoctocog alfa (fattur VIII tal-koagulazzjoni tal-bniedem (rDNA))
English: USA
Maltese: Organi
English: After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: Wara r-rikostituzzjoni NovoEight fih madwar 125 IU/ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Maltese: Tabella 6 Parametri farmakokinetiċi ta' doża waħda ta' NovoEight (50
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Maltese: Huwa magħmul permezz ta' teknoloġija ta' DNA rikombinanti f'ċelluli tal-ovarji tal-ħamster Ċiniż (CHO - Chinese hamster ovary), u jiġi ppreparat mingħajr iż-żieda ta' kwalunkwe proteina ġejja mill-bnedmin jew mill-annimali fil-proċess ta' koltura taċċellula, fil-purifikazzjoni, jew fil-formulazzjoni finali.
English: NovoEight 1500 IU EU/1/13/888/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/888/004
English: Anti factor VIII antibody positive
Maltese: Pożittiv għall-antikorp kontra l-fattur VIII
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Maltese: Il-pakkett fih: kunjett wieħed ta' trab, 4 ml ta' solvent f'siringa mimlija għal-lest, lasta tal-planġer u adapter tal-kunjett
English: Vial adapter Protective cap
Maltese: Adapter tal-kunjett
English: Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: • rash, hives, weals or generalised itching
Maltese: • raxx, ħorriqija, ġrieħi jew ħakk mifrux
English: NovoEight 1000 IU EU/1/13/888/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/888/003
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati bl-ewwel sinjali ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja mifruxa, tagħfis fis-sider, tħarħir, pressjoni baxxa u anafilassi.
English: NovoEight 2000 IU powder and solvent for solution for injection.
Maltese: NovoEight huwa trab u solvent għal soluzzjoni għall-injezzjoni.
English: In adults and adolesents (>12 years) a less frequent regimen (40-60 IU/kg every third day or twice weekly) may be applicable.
Maltese: Fl-adulti u fl-adolexxenti (>12-il sena) tista' tapplika skeda anqas frekwenti (40-60
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: Wara r-rikostituzzjoni NovoEight fih madwar 750 IU/ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: NovoEight 2000 IU EU/1/13/888/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/888/005
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Maltese: Tabella 7 Parametri farmakokinetiċi ta' doża waħda ta' NovoEight (50
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observation and laboratory test.
Maltese: B'mod ġenerali, il-pazjenti kollha kkurati bi prodotti tal-fattur VIII għandhom jiġu mmonitorjati b'attenzjoni għall-iżvilupp ta' impedituri permezz ta' osservazzjoni klinika xierqa u test tal-laboratorju.
English: Rubber stopper (under plastic cap)
Maltese: Tapp tal-gomma (taħt it-tapp tal-plastik)
English: • feeling tired
Maltese: Tqala u treddigħ
English: 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Maltese: Jekk inti ma tistax tuża s-soluzzjoni rrikostitwita ta' NovoEight immedjatament, hija tista' tintuża fi żmien 4 sigħat meta tinħażen f'temperatura tal-kamra jew sa 40°C u fi żmien 24 siegħa meta tinħażen f'temperatura ta' 2°C - 8°C.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Maltese: Jekk ikun hemm bżonn ta' apparat li jagħti aċċess għall-vina ċentrali (CVAD), wieħed irid joqgħod attent għar-riskju ta' kumplikazzjonijiet marbuta ma' CVAD li jinkludu infezzjonijiet lokali, batterimja u trombożi fis-sit tal-kateter.
English: • bruising
Maltese: • tbenġil
English: After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Maltese: Wara r-rikostituzzjoni NovoEight fih madwar 250 IU/ml ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa.
English: Activated factor VIII acts as a co-factor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Maltese: Il-fattur VIII attivat jiffunzjona bħala kofattur għall-fattur IX attivat, li jaċċellera l-bidla tal-fattur X f'fattur X attivat.
English: One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Maltese: Ml wieħed ta' NovoEight fih madwar 375 IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa wara r-rikostituzzjoni
English: In patients with existing cardiovascular risk factors, substitiution therapy with FVIII may increase the cardiovascular risk.
Maltese: F'pazjenti li diġà għandhom fatturi ta' riskju kardjovaskulari, terapija ta' sostituzzjoni b'FVIII tista' żżid irriskju kardjovaskulari.
English: NovoEight 500 IU EU/1/13/888/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/888/002
English: • difficulty sleeping (insomnia)
Maltese: • tbati biex torqod (insomnja)
English: Overview Vial with NovoEight powder
Maltese: Kunjett bit-trab NovoEight
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
Maltese: • 'il fuq mit-temperatura tal-kamra (30°C sa 40°C) għal perjodu wieħed li ma jkunx itwal minn 3 xhur.
English: - Keep this leaflet.
Maltese: • Iċċekkja d-data ta' skadenza.
English: Number of patients Dose used for prevention per patient (IU/kg BW) Mean (SD) Min ; Max Dose used for treatment of bleed (IU/kg BW)
Maltese: Numru ta' pazjenti Doża użata għallprevenzjoni f'kull pazjent (IU/kg BW) Medja (SD) Min ; Max
English: Do not touch the sides or the thread of the plunger rod.
Maltese: Jekk iseħħu reazzjonijiet allerġiċi qawwija, f'daqqa waħda (reazzjonijiet anafilattiċi) (rari ħafna), l-injezzjoni għandha titwaqqaf immedjatament.
English: One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Maltese: Ml wieħed ta' NovoEight fih madwar 125 IU ta' fattur VIII tal-koagulazzjoni tal-bniedem (rDNA), turoctocog alfa wara r-rikostituzzjoni
English: Psychiatric disorders Uncommon
Maltese: Parametru PK Piż inqas minn normali
English: 88397 Biberach an der Riss Germany
Maltese: 88397 Biberach an der Riss Il-Ġermanja
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin Odds ratio
Maltese: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Proporzjon ta' periklu
English: Observation N=1697***
Maltese: Osservazzjoni N=1697***
English: Chemo + Trastuzumab (n=115)
Maltese: Kimo + Trastuzumab (n=115)
English: Circulating shed HER2 ECD
Maltese: Shed HER2 ECD fiċ-ċirkolazzjoni
English: Overexpression of HER2 is observed in 20%-30% of primary breast cancers.
Maltese: Espressjoni żejda ta' HER2 hija osservata f'20 %-30 % ta' kanċers primarji tas-sider.
English: Infusion-related reactions (IRRs) and hypersensitivity
Maltese: Reazzíonijiet relatati mal-infużjoni (IRRs - infusion-related reactions) u sensittività eccessiva
English: Observation N=1693
Maltese: Osservazzjoni N=1693
English: Cmin,ss* (µg/mL)
Maltese: Cmin,ss* (gg/mL)
English: Table 13 Efficacy Results from BO18225 Parameter
Maltese: Tabella 13 Riżultati tal-Effikaċja minn BO18225 Parametru
English: N=105
Maltese: Trastuzumab N=105
English: Table 12 Efficacy Results from MO16432 Parameter
Maltese: Tabella 12 Riżultati tal-Effikaċja minn MO16432 Parametru
English: Cmin,ss = Cmin at steady state Cmax,ss = Cmax at steady state time to 90% of steady-state
Maltese: Cmin,ss - Cmin fi stat fiss Cmax,ss = Cmax fi stat fiss żmien sakemm jintlaħaq 90% ta' stat fiss
English: Trastuzumab plus paclitaxel N=68
Maltese: Trastuzumab ma' paclitaxel N=68
English: Trazimera is a biosimilar medicinal product.
Maltese: Trazimera huwa prodott mediċinali bijoloġiku simili.
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Maltese: Madankollu, trastuzumab jista' jgħolli l-esponiment globali ta' metabolit wieħed ta' doxorubicin, (7- deoxy-13 dihydro-doxorubicinone, D7D).
English: Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC 2+/FISH+ or IHC 3+).
Maltese: Analiżi post-hoc ta' sottogruppi tindika li effetti pożittivi tal-kura huma limitati biex jolqtu tumuri b'livelli ogħla tal-proteina HER2 (IHC 2+/FISH+ jew IHC 3+).
English: Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Maltese: Tabella 10 Sommarju tal-Analiżi tal-Effikaċja ta' BCIRG 006 AC→D kontra DcarbH Parametru
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 µg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients.
Maltese: Il-valuri tal-parametru ta' eliminazzjoni mhux lineari kienu ta' 8.81 mg/jum għar-rata massima ta' eliminazzjoni (Vmax - maximum elimination rate) u ta' 8.92 qg/mL għall-kostanti ta' Michaelis-Menten (Km - Michaelis-Menten constant) għall-pazjenti b'MBC, EBC, u AGC.
English: Pulmonary fibrosis
Maltese: Fibrożi pulmonari
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for AGC.
Maltese: It-tneħħija lineari kienet ta' 0.136 L/jum għal MBC, 0.112 L/jum għal EBC u 0.176 L/jum għal AGC.
English: For monotherapy, the rate was 6% - 9%.
Maltese: Għall-monoterapija, ir-rata kienet ta' 6 % - 9 %.
English: Boehringer Ingelheim Pharma GmbH & Co KG Birkendorfer Straße 65
Maltese: Boehringer Ingelheim Pharma GmbH & Co
English: N=172
Maltese: Trastuzumab N=172
English: Trastuzumab plus docetaxel N=92
Maltese: Trastuzuma b ma' docetaxel N=92
English: Observed with combination therapy following anthracyclines and combined with taxanes
Maltese: * Osservat b'terapija kombinata wara anthracyclines u flimkien ma' taxanes
English: Trastuzumab plus docetaxel N=110
Maltese: Trastuzumab flimkien ma' docetaxel N=110
English: N=72
Maltese: Trastuzumab N=72
English: Trastuzumab 1 Year N=1702***
Maltese: TrastuzumabSena Waħda N=1702***
English: Study WO16229: loading dose 8 mg/kg, followed by 6 mg/kg 3 weekly schedule Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule Study BO15935
Maltese: Studju WO16229: doża ogħla tal-bidu ta' 8 mg/kg, segwita minn kors ta' 6 mg/kg kull 3 ġimgħat Studju MO16982: doża ogħla tal-bidu ta' 6 mg/kg fil-ġimgħa x 3; segwita minn kors ta' 6 mg/kg kull 3 Studju BO15935
English: Combination Therapy
Maltese: Terapija Kombinata
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Maltese: Fl-istudju BCIRG 006, 213/1075 pazjent fil-grupp DCarbH (TCH) , 221/1074 pazjent fil-grupp AC→DH (AC→TH), u 217/1073 fil-grupp AC→D (AC→T) kellhom stat ta' ħila Karnofsky ta' ≤90 (80 jew 90).
English: • (hypertonia)
Maltese: (ipertonija)
English: Trazimera 150 mg powder for concentrate trastuzumab
Maltese: Trazimera 150 mg trab għal-konċentrat trastuzumab
English: The reconstituted Trazimera solution contains 21 mg/mL of trastuzumab.
Maltese: Is-soluzzjoni rikostitwita ta' Trazimera fiha 21 mg/mL ta' trastuzumab.
English: MBC 805 0.183 - 0.302 EBC 390 0.158 - 0.253 AGC 274 0.189 - 0.337
Maltese: EBC 390 0.158 - 0.253 AGC 274 0.189 - 0.337
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Maltese: Riversibilità ta' CHF severa (definita bħala sekwenza ta' mill-inqas żewġ valuri konsekuttivi ta' LVEF ta' ≥ 50 % wara l-avveniment) kienet evidenti għal 71.4 % tal-pazjenti kkurati bi trastuzumab.
English: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Maltese: Kura b'AC→PH irriżultat ftitjib statistikament sinifikanti fOS meta mqabbel ma'AC→P (HR stratifikat=0.64; CI ta' 95% [0.55, 0.74]; valur p log-rank < 0.0001).
English: (µg.day/mL)
Maltese: (qg/mL)
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Maltese: Firxa ta' t1/2 minn Cmax,ss sa C
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC 3+/FISH+ group.
Maltese: Għas-sopravivenza globali, HR kien ta' 0.75 (CI ta' 95 % 0.51-1.11) fil-grupp ta' IHC 2+/FISH+ u HR kien ta' 0.58 (CI ta' 95 % 0.410.81) fil-grupp ta' IHC 3+/FISH+.
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Maltese: Aktar minn 70 % tal-pazjenti rreġistrati wrew espressjoni żejda ta' 3+.
English: Respiratory distress
Maltese: Distress respiratorju
English: System organ class
Maltese: Klassi tas-sistemi U tal-organi
English: Parameter Monotherapy
Maltese: Parametru Monoterapija
English: 150 mg vial
Maltese: 150 mg kunjett