FrancophonIA/ELRC3.0 huggingface dataset:
English: Use infusion bags that are free of di(2-ethylhexyl)phthalate (DEHP).
Maltese: Uża boroż tal-infużjoni li ma jkunx fihom di(2-ethylhexyl)phthalate (DEHP).
English: Dyspepsia
Maltese: Pożoloġija
English: Clinical efficacy
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: If refrigeration is not available, Onpattro can be stored at room temperature up to 25°C for up to 14 days.
Maltese: Jekk friġġ ma tkunx disponibbli, Onpattro jista' jinħażen f'temperatura tal-kamra sa 25°C għal massimu ta' 14-il jum.
English: Clinical studies did not identify significant differences in steady state pharmacokinetic parameters or TTR reduction according to gender or race (non-Caucasian vs. Caucasian).
Maltese: L-istudji kliniċi ma identifikawx differenzi sinifikanti fl-istat fiss tal-parametri farmakokinetiċi jew fit-tnaqqis ta' TTR skont il-sess jew ir-razza (mhux Kawkażi vs.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, the mean ± SD steady-state volume of distribution (Vss) of patisiran, DLin-MC3-DMA and PEG2000-C-DMG was 0.26 ± 0.20 L/kg, 0.47 ± 0.24 L/kg and 0.13 ± 0.05 L/kg, respectively.
Maltese: Fil-kors ta' dożaġġ ta' 300 mikrogramma għal kull kilo kull 3 ġimgħat, il-medja tal-istat fiss tal-volum ta' distribuzzjoni (Vss) ta' patisiran ± SD, DLin-MC3-DMA u PEG2000-C-DMG kienet ta' 0.26 ± 0.20
English: This endpoint is a composite measure of motor, sensory, and autonomic polyneuropathy including assessments of motor strength and reflexes, quantitative sensory testing, nerve conduction studies, and postural blood pressure, with the score ranging from 0 to 304 points, where an increasing score indicates worsening impairment.
Maltese: Dan il-punt aħħari hu kejl kompost talpolinewropatija motriċi, sensorja u awtonomika li jinkludi l-valutazzjoni tas-saħħa motriċi u r-riflessi, l-ittestjar sensorjali kwantitattiv, l-istudji ta' konduzzjoni tan-nervaturi, u l-pressjoni tad-demm kif tqum bilwieqfa, b'punteġġ li jvarja minn 0 għal 304 punti, fejn punteġġ li jiżdied jindika deterjorament tal-indeboliment.
English: • Pain in the joints (arthralgia)
Maltese: • Uġigħ fil-ġogi (artralġja)
English: Less than 1% of patisiran in the administered dose was recovered intact in urine.
Maltese: Inqas minn 1% ta' patisiran fid-doża mogħtija tneħħiet mhux mibdula fl-awrina.
English: • The usual dose of Onpattro is 300 micrograms per kilogram (kg) of body weight given once every
Maltese: • Id-doża tas-soltu ta' Onpattro hi ta' 300 mikrogrammi għal kull kilo (kg) ta' piż tal-ġisem,
English: Onpattro Placebo
Maltese: 0-il punt bil-plaċebo.
English: • The diluted solution of Onpattro should be infused intravenously over approximately 80 minutes at an initial infusion rate of approximately 1 mL/min for the first 15 minutes, followed by an increase to approximately 3 mL/min for the remainder of the infusion.
Maltese: • L-infużjoni tas-soluzzjoni dilwita ta' Onpattro għandha tkun infuża ġol-vini għal madwar 80 minuta b'rata ta' infużjoni inizjali ta' madwar 1 mL/min għall-ewwel 15-il minuta, u wara għandu jkun hemm żieda għal madwar 3 mL/min għall-bqija tal-infużjoni.
English: • Onpattro must be diluted prior to intravenous infusion (see instructions in section 6.6).
Maltese: • Onpattro jrid jiġi dilwit qabel l-infużjoni ġol-vini (ara l-istruzzjonijiet f'sezzjoni 6.6).
English: No formal clinical drug interaction studies have been performed.
Maltese: Ma twettqu l-ebda studji kliniċi formali ta' interazzjoni.
English: • The appropriate infusion rate;
Maltese: • Adattabilità tal-pazjent għall-infużjoni mid-dar;
English: The infusion sets must be free of di(2-ethylhexyl)phthalate (DEHP).
Maltese: Is-settijiet ta' infużjoni ma jridx ikun fihom di(2-ethylhexyl)phthalate (DEHP).
English: What Onpattro contains
Maltese: Reazzjoni relatata mal infużjoni
English: All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs).
Maltese: Il-pazjenti kollha għandhom jirċievu l-premedikazzjoni qabel ma jingħataw l-Onpattro biex jitnaqqas ir-riskju tar-reazzjonijiet relatati mal-infużjoni (IRRs).
English: Benefits relative to placebo were also observed across all mNIS+7 components.
Maltese: F'analiżi ta' limtu ta' mNIS+7
English: Ninetythree percent (93%) of Onpattro-treated and 62% of placebo-treated patients completed 18 months of the assigned treatment.
Maltese: Tlieta u disgħin fil-mija (93%) tal-pazjenti ttrattati b'Onpattro u 62% tal-pazjenti ttrattati bi plaċebo lestew it-18-il xahar tat-trattament assenjat.
English: Approximately half of patients (56%) met pre-defined criteria for cardiac involvement (defined as baseline LV wall thickness ≥ 13 mm with no history of hypertension or aortic valve disease).
Maltese: Madwar nofs il-pazjenti (56%) laħqu kriterja predefinita għal involviment kardijaku (definit bħala l-linja bażi tal-ħxuna tal-ħajt tal-LV ≥ 13 mm mingħajr storja medika ta' pressjoni għolja jew mard tal-valv tal-aorta).
English: The diluted solution should be administered immediately after preparation.
Maltese: Is-soluzzjoni dilwita għandha tingħata immedjatament wara l-preparazzjoni.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna wara “JIS”.
English: Among Onpattro-treated patients who experienced an IRR, 78.6% experienced the first IRR within the first 2 infusions.
Maltese: Fost il-pazjenti ttrattati b'Onpattro li esperjenzaw IRR, 78.6% tagħhom esperjenzaw l-ewwel IRR fl-ewwel 2 infużjonijiet.
English: Onpattro has not been studied in patients with moderate or severe hepatic impairment.
Maltese: Onpattro ma ġiex studjat f'pazjenti b'indeboliment epatiku moderat jew sever.
English: If such signs are present, vitamin A supplementation should not exceed 2500 IU per day.
Maltese: Wara dan, is-supplimentazzjoni ta' vitamina A ta' 2500
English: METHOD OF ADMINISTRATION Do not shake or vortex.
Maltese: METODU TA' KIF GĦANDU JINGĦATA Tħawdux jew tagħmilx vortex.
English: In lactating rats, patisiran was not present in milk, although small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG were present in milk (up to 7% of concomitant maternal plasma concentrations).
Maltese: Fil-firien li qed ireddgħu, patisiran ma kienx preżenti fil-ħalib, għalkemm ammonti żgħar tal-komponenti lipidi DLin-MC3-DMA u PEG2000-C-DMG kienu preżenti fil-ħalib (sa 7% tal-konċentrazzjonijiet konkomitanti tal-plażma tal-omm).
English: Intravenous administration of Onpattro led to increases in serum liver markers (ALT, AST, ALP, and/or total bilirubin) and histopathology findings in the liver (hepatocellular/single cell necrosis, inflammation, pigment deposition, and/or monocytic infiltration) at doses > 100 micrograms per kg every 4 weeks and > 1.0 mg/kg every 3 weeks in rats and monkeys, respectively.
Maltese: infjammazzjoni, depożizzjoni tal-pigment, u/jew infiltrazzjoni monoċitika) f'dożi > 100 mikrogramma għal kull kilo kull 4 ġimgħat u > 1.0 mg/kg kull 3 ġimgħat fil-firien u x-xadini, rispettivament.
English: The primary efficacy endpoint was the change from baseline to 18 months in modified Neuropathy Impairment Score +7 (mNIS+7).
Maltese: Il-punt aħħari tal-effikaċja primarja kienet il-bidla mil-linja bażi għal 18-il xahar fil-Punteġġ modifikat ta' Indeboliment tan-Newropatija +7 (mNIS+7).
English: (−27.2, −15.0) p < 0.001
Maltese: 001) (Tabella 2).
English: Children and adolescents Onpattro is not recommended in children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Onpattro mhuwiex għall-użu fi tfal u adolexxenti taħt it-18-il sena.
English: At the dose regimen of 300 micrograms per kg every 3 weeks, mean ± SD steady state plasma clearance (CLss) of patisiran was 3.0 ± 2.5 mL/h/kg.
Maltese: Fil-kors ta' dożaġġ ta' 300 mikrogramma għal kull kilo kull 3 ġimgħat, il-medja tal-istat fiss tattneħħija tal-plażma ± SD (CLss) ta' patisiran kienet ta' 3.0 ± 2.5 mL/h/kg.
English: Patients were randomised 2:1 to receive 300 micrograms per kg Onpattro or placebo via intravenous infusion once every 3 weeks for 18 months.
Maltese: Il-pazjenti ġew randomised 2:1 biex jirċievu 300 mikrogramma għal kull kilo Onpattro jew plaċebo permezz ta' infużjoni ġol-vini darba kull 3 ġimgħat għal 18-il xahar.
English: Other medicines and Onpattro
Maltese: Mediċini oħra u Onpattro
English: The accumulation of AUCτ was 1.76-fold at steady-state compared to the first dose.
Maltese: L-akkumulazzjoni ta' AUCτ kienet 1.76 darbiet aktar fl-istat fiss meta mqabbel mal-ewwel doża.
English: Missed dose
Maltese: FEJN MA
English: B. PACKAGE LEAFLET
Maltese: Eċċipjenti b'effett magħruf
English: The Norfolk QoL-DN questionnaire (patient-reported) includes domains relating to small fibre, large fibre, and autonomic nerve function, symptoms, and activities of daily living, with the total score ranging from -4 to 136, where an increasing score indicates worsening quality of life.
Maltese: Il-kwestjonarju ta' Norfolk QoL-DN (irrappurtat mill-pazjenti) jinkludi oqsma relatati mal-fibra żgħira, fibra kbira, u l-funzjoni tan-nervituri awtonomika, sintomi, u attivitajiet tal-ħajja ta'
English: Serum vitamin A levels below the lower limit of normal should be corrected and any ocular symptoms or signs due to vitamin A deficiency should be evaluated prior to initiation of treatment with Onpattro.
Maltese: Livelli ta' vitamina A fis-serum taħt il-limitu aktar baxx tan-normal għandhom jiġu kkoreġuti u kwalunkwe sintomu okulari jew sinjal minħabba defiċjenza ta' vitamina A għandu jiġi evalwat qabel il-bidu tat-trattament b'Onpattro.
English: IV use after dilution
Maltese: Użu IV wara d-dilwazzjoni
English: • Stuffy or runny nose (rhinitis)
Maltese: • Imnieħer imblukkat jew inixxi (rinite)
English: Patisiran and the lipid components exhibit linear and time-independent pharmacokinetics with chronic dosing at the dose regimen of 300 micrograms per kg every 3 weeks.
Maltese: Il-patisiran u l-komponenti lipidi għandhom propjetajiet farmakokinetiċi lineari u independenti mill-ħin b'dożaġġ kroniku fir-reġim ta' dożaġġ ta' 300 mikrogramma għal kull kilo kull 3 ġimgħat.
English: bA lower number indicates less impairment/fewer symptoms.
Maltese: (MMRM, mixed-effect model repeated measures). bNumru aktar baxx jindika inqas indeboliment/sintomi.
English: Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis.
Maltese: TWISSIJA SPEĊJALI LI LPRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: • The active substance is trastuzumab.
Maltese: • Is-sustanza attiva hi trastuzumab.
English: Study BO15935
Maltese: 3. Studju BO15935
English: Study MO16419
Maltese: Studju MO16419
English: Overall response rate,%
Maltese: Rata ta' rispons globali, %
English: AUCss, 0-21days
Maltese: AUCss, 0-21jum
English: 1Palpitation
Maltese: 1Palpitazzjoni
English: 9744 AP Groningen The Netherlands
Maltese: 9744 AP Groningen L-Olanda
English: AUC0-21days
Maltese: AUC0-21jum
English: Chemo + trastuzumab (n = 115)
Maltese: Kimo + trastuzumab (n = 115)
English: Sites of progression
Maltese: Siti ta' progressjoni
English: Negative
Maltese: Negattiv
English: Observation N = 1,693
Maltese: Osservazzjoni N = 1,693
English: Immunex Rhode Island Corporation 40 Technology Way West Greenwich
Maltese: Immunex Rhode Island Corporation 40
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Maltese: TTP = żmien sa progressjoni; “ne” jindika li ma setax jiġi stmat jew kien għadu ma ntlaħaqx.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 16 ta' Mejju 2018
English: AC→PH (vs.AC→P) (NSABP B-31 and NCCTG N9831)*
Maltese: AC→PH (kontra AC→P) (NSABP B-31 u NCCTG N9831)*
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: Reazzjonijiet relatati mal-infużjoni (IRRs - infusion-related reactions) u sensittività eċċessiva
English: Circulating shed HER2-ECD
Maltese: Shed HER2 ECD fiċ-ċirkolazzjoni
English: 3 weeks.
Maltese: 3 snin.
English: p-value versus AC→P
Maltese: Valur p kontra AC→P
English: Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, The Netherlands
Maltese: Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, L-Olanda
English: AC→DH (vs. AC→D) (BCIRG 006)
Maltese: AC→DH (kontra AC→D) (BCIRG 006)
English: Observation N = 1697***
Maltese: Osservazzjoni N = 1,697***
English: * Observed with combination therapy following anthracyclines and combined with taxanes.
Maltese: * Osservat b'terapija kombinata wara anthracyclines u flimkien ma' taxanes.
English: Trastuzumab 1 Year N = 1,702***
Maltese: Trastuzumab Sena Waħda N = 1,702***
English: DCarbH (vs. AC→D) (BCIRG 006)
Maltese: DCarbH (kontra AC→D) (BCIRG 006)
English: +Bronchospasm
Maltese: +Bronkospażmu
English: Pulmonary events
Maltese: Avvenimenti pulmonari
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 tat-trattament huma limitati biex jolqtu tumuri b'livelli ogħla tal-proteina HER2 (IHC 2+/FISH+ jew IHC 3+).
English: Heart checks).
Maltese: Testijiet tal-qalb).
English: FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Maltese: Tul tar-rispons, xhur medjana FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a Proporzjon ta' periklu
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: *Cmin,ss - Cmin at steady-state **Cmax,ss = Cmax at steady-state *** time to 90% of steady-state
Maltese: EBC 390 *Cmin,ss - Cmin fi stat fiss **Cmax,ss = Cmax fi stat fiss *** żmien sakemm jintlaħaq 90% ta' stat fiss
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 µg/mL għall-kostanti ta' Michaelis-Menten (Km -Michaelis-Menten constant) għall-pazjenti b'MBC, EBC, u AGC.
English: Trastuzumab plus docetaxel4 N = 110
Maltese: Trastuzumab flimkien ma' docetaxel4 N = 110
English: Study H0649g: IHC3+ patient subset
Maltese: Studju H0649g: sotto-sett ta' pazjenti IHC3+ 2.
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Maltese: Minnoranza ta' pazjenti ġew ittestjati blużu ta' fluorescence in-situ hybridisation (FISH).
English: +Pulmonary fibrosis
Maltese: +Fibrożi pulmonari
English: Depression
Maltese: Depressjoni
English: - Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Maltese: - Doxorubicin 60 mg/m2 u paclitaxel 150 mg/m2, mogħtija darba kull 3 ġimgħat għal 3 ċikli,
English: For monotherapy, the rate was 6% - 9%.
Maltese: Għall-monoterapija, ir-rata kienet ta' 6% - 9%.
English: Dermatitis
Maltese: Dermatite
English: See section 5.1 for chemotherapy combination dosing.
Maltese: Ara sezzjoni 5.1 għad-dożaġġ ta' kimoterapija kombinata.
English: • respiratory distress
Maltese: • distress respiratorju
English: KANJINTI is a biosimilar medicinal product.
Maltese: KANJINTI huwa prodott mediċinali bijoloġiku simili.
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisasteżija palmariplantari
English: Trastuzumab plus paclitaxel3 N = 32
Maltese: Trastuzumab flimkien ma' Paclitaxel3 N = 32
English: Linear clearance was 0.136 L/day for MBC, 0.112 L/day for EBC and 0.176 L/day for
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: Hypertonia
Maltese: Ipertonija
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up** Hazard ratios (95% CI) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval * At the time of the definitive analysis of DFS.
Maltese: Proporzjonijiet ta' periklu tal-analiżi esploratorja posthoc ta' Segwitu fit-tul** ta' DFS u ta' avvenimenti sintomatiċi tal-qalb (CI ta' 95%) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza * Fil-ħin tal-analiżi definittiva ta' DFS.
English: Table 6 Efficacy results from study BO16348
Maltese: Riżultati tal-effikaċja minn studju BO16348
English: For storage conditions of the reconstituted medicinal product, see section 6.3 and 6.6.
Maltese: Għall-kondizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3 u 6.6. 6.5
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development period was observed.
Maltese: Kien osservat li trastuzumab għadda mill-plaċenta fil-perjodu bikri (20-50 jum ta' tqala) u dak tard (120-150 jum ta' tqala) tal-iżvilupp tal-fetu.
English: The incidence of symptomatic cardiac dysfunction was 1.7% in the trastuzumab arm.
Maltese: L-inċidenza ta' disfunzjoni kardijaka sintomatika kienet ta' 1.7% fil-grupp ta' trastuzumab.
English: Clinical experience is limited in patients above 65 years of age.
Maltese: Esperjenza klinika hija limitata f'pazjenti b'età 'l fuq minn 65 sena.
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Maltese: Amplifikazzjoni tal-ġene HER2 għandha tiġi osservata permezz ta' fluorescence in situ hybridisation (FISH) jew chromogenic in situ hybridisation (CISH) ta' blokki fissi tat-tumur.
English: Trastuzumab plus paclitaxel2 N = 68
Maltese: Trastuzumab ma' paclitaxel2 N = 68
English: Peripheral oedema
Maltese: Edima periferali
English: +Acute pulmonary oedema
Maltese: +Edima pulmonari akuta
English: Final concentration
Maltese: Konċentrazzjoni finali
English: Total pathological complete response* (95% CI)
Maltese: Rispons patoloġiku komplut totali* (CI ta' 95%)
English: ANNEX II
Maltese: Tabella 2.
English: +Respiratory distress
Maltese: +Distress respiratorju
English: (µg.day/mL)
Maltese: (µg.jum/mL)
English: Greater than 70% of patients enrolled exhibited 3+ overexpression.
Maltese: Aktar minn 70% tal-pazjenti rreġistrati wrew espressjoni żejda ta' 3+.
English: Trastuzumab plus docetaxel3 N = 92
Maltese: Trastuzumab ma' docetaxel3 N = 92
English: Trastuzumab 1 Year N = 1,693
Maltese: Trastuzumab Sena Waħda N = 1,693
English: +Pneumonia
Maltese: +Pulmonite
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Maltese: Pazjenti b'MBC u EBC kellhom parametri PK (eż. tneħħija (CL - clearance), volum tal-kompartiment ċentrali (Vc -central compartment volume)) u esponimenti fi stat fiss imbassra mill-popolazzjoni (Cmin, Cmax u AUC) simili.
English: The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Maltese: Il-volum tal-kompartiment ċentrali kien ta' 2.62 L għall-pazjenti b'MBC u EBC u ta' 3.63 L għall-pazjenti b'AGC.
English: +Acute respiratory distress syndrome
Maltese: +Sindrome ta' distress respiratorju akut
English: +1Supraventricular tachyarrhythmia
Maltese: +1Taki-arritmija supraventrikolari
English: - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Maltese: - wara kirurġija, kimoterapija (neo-awżiljarja jew awżiljarja) u radjuterapija (jekk applikabbli) (ara sezzjoni 5.1).
English: Median follow-up 8 years**
Maltese: Segwitu medjan 8 snin**
English: Table 12 Efficacy results from MO16432
Maltese: Riżultati tal-effikaċja minn MO16432
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: Trattament b'AC→PH irriżulta f'titjib statistikament sinifikanti f'OS meta mqabbel ma'AC→P (HR stratifikat = 0.64; CI ta' 95% [0.55, 0.74]; valur p log-rank < 0.0001).
English: Total CL range from Cmax,ss to Cmin,ss
Maltese: Firxa ta' CL totali minn Cmax,ss sa Cmin,ss (L/jum)
English: No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Maltese: Ma kinux osservati inkompatibilitajiet bejn KANJINTI u boroż tal-polyvinylchloride, polyethylene jew polypropylene.
English: Primary tumour type
Maltese: Tip ta' tumur primarju
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Barra minn hekk, trastuzumab huwa medjatur qawwi ta' ċitotossiċità medjata miċċelluli dipendenti minn antikorpi (ADCC - antibody-dependent cell-mediated cytotoxicity).
English: Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class II-IV) or asymptomatic cardiac dysfunction.
Maltese: Pazjenti ttrattati b'KANJINTI huma f'riskju akbar għall-iżvilupp ta' CHF (New York Heart Association [NYHA] klassi II-IV) jew disfunzjoni kardijaka mhux sintomatika.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1%-4% for paclitaxel alone.
Maltese: Fil-provi pivitali dwar metastasi b'trastuzumab fil-vini, l-inċidenza ta' disfunzjoni kardijaka varjat bejn 9% u 12% meta dan kien ikkombinat ma' paclitaxel meta mqabbla ma' 1% - 4% għal paclitaxel waħdu.
English: KANJINTI contains the active substance trastuzumab, which is a monoclonal antibody.
Maltese: KANJINTI fih is-sustanza attiva trastuzumab, li huwa antikorp monoklonali.
English: Papilloedema
Maltese: Papilloedima
English: Primary efficacy analysis DFS Hazard ratios (95% CI) p-value p < 0.0001
Maltese: Proporzjonijiet ta' periklu tal-analiżi primarja taleffikaċja ta' DFS (CI ta' 95%) valur p p < 0.0001
English: Cardiac disorders
Maltese: Disfunzjoni kardijaka
English: MBC 805 EBC 390
Maltese: MBC 805
English: LIST OF EXCIPIENTS Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Maltese: TA' EĊĊIPJENTI Histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
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, 213/1,075 pazjent fil-grupp DCarbH (TCH), 221/1,074 pazjent fil-grupp AC→DH (AC→TH), u 217/1,073 fil-grupp AC→D (AC→T) kellhom stat ta' ħila Karnofsky ta' ≤ 90 (80 jew 90).
English: neck pain haemorrhoids bone pain itchiness acne leg cramps
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA
English: Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting (see section 4.8).
Maltese: Avvenimenti pulmonari severi kienu rrappurtati bl-użu ta' trastuzumab wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: LIST OF EXCIPIENTS Excipients: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.
Maltese: Eċċipjenti: histidine, histidine monohydrochloride, trehalose dihydrate, polysorbate 20.