FrancophonIA/ELRC3.0 huggingface dataset:
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Maltese: n = 44) fi studju każwali, double-blind, bil-plaċebo bħala kontroll, ta' 8 ġimgħat fejn ġie użat grupp ta' trattament b'doża fissa abbażi tal-piż fuq firxa ta' dożi ta' bejn 5 mg/jum sa
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Maltese: • reazzjoni allerġika (eż. nefħa fil-ħalq, ilsien, wiċċ u gerżuma, ħakk, raxx),
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Maltese: Milli nafu mill-istudji in vitro, l-enżimi CYP3A4 u CYP2D6 jagħmlu de-idroġinazzjoni u idroksilazzjoni ta' aripiprazole, u CYP2D6
English: Hepatic failure Hepatitis Jaundice
Maltese: Logħob patoloġiku tal-ażżard
English: ABILIFY 30 mg orodispersible tablets Red iron oxide (E 172)
Maltese: ABILIFY 30 mg pilloli li jinħallu fil-ħalq Iron oxide aħmar (E 172)
English: ABILIFY 10 mg tablets Red iron oxide (E 172)
Maltese: ABILIFY 10 mg pilloli li jinħallu fil-ħalq Iron oxide aħmar (E 172)
English: In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Maltese: Fi studji ta' vvellenar reprodduttiv mill vini, ma kien osservat l-ebda tħassib ġdid li jikkonċerna s-saħħa f'espożizzjonijiet materni sa 15 (far) u 29 (fenek) darba l-espożizzjoni umana ta' 30 mg.
English: Oral Solution
Maltese: Soluzzjoni orali
English: It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Maltese: Phenylalanine jista' jkun ta' ħsara jekk int għandek fenilketonurja (phenylketonuria (PKU), disturb ġenetiku rari fejn phenylalanine jakkumula għaliex il-ġisem ma jistax ineħħih sewwa.
English: Orange flavour
Maltese: Indeboliment tal-fwied
English: Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered unchanged in the faeces.
Maltese: ta' aripiprazole mhux imbiddel tneħħa fl-awrina u bejn wieħed u ieħor 18 % inġabar mhux mibdul fl ippurgar.
English: Up to three injections in 24 hours may be given.
Maltese: Jistgħu jingħataw sa tlett injezzjonijiet f'24 sigħa.
English: In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Maltese: Ħsibijiet u mġiba suwiċidali ġew irrappurtati waqt trattament b'aripiprazole.
English: Orodispersible tablet
Maltese: Żieda fil-piż
English: Treatment should be initiated at 2 mg (using ABILIFY oral solution 1 mg/mL) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg.
Maltese: Il-kura għandha tinbeda b'doża ta' 2 mg (bl-użu ta' ABILIFY soluzzjoni orali 1 mg/mL), għal jumejn, ittitrata għal 5 mg għal jumejn addizzjonali biex tilħaq id-doża rakkomandata ta' kuljum ta' 10 mg.
English: ABILIFY orodispersible tablets contain lactose.
Maltese: Il-prevenzjoni tar-rikorrenza ma ġietx stabbilita.
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Maltese: Aripiprazole għandu jintuża b'attenzjoni f'pazjenti b'riskju ta' pnewmonja minn aspirazzjoni.
English: However, in a single-dose, intramuscular study of aripiprazole (dose 15 mg) in healthy subjects, administered simultaneously with intramuscular lorazepam (dose 2 mg), the orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone.
Maltese: Madankollu, fi studju b'doża waħda ta' aripiprazole (doża 15 mg) ġol-muskolu, f'nies b'saħħithom, mogħtija simultanjament ma' lorazepam (doża 2 mg) ġol-muskolu, l-intensità tas-sedazzjoni kienet akbar bittnejn flimkien meta mqabbla ma' dik osservata minn aripiprazole waħdu.
English: However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Maltese: Madankollu, f'waħda minn dawn il-provi, prova b'doża fissa, kien hemm konnessjoni sinifikanti ta' rispons għad-droga għal reazzjonijiet avversi ċerebrovaskulari f'pazjenti kkurati b'aripirazole (ara sezzjoni 4.8).
English: Suicidality The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Maltese: Suwiċidalità Hemm l-eżistenza ta' tendenzi suwiċidjali f'mard psikotiku u disturbi fil-burdata u f'xi każijiet ġiet irrappurtata hekk kif bdiet jew inbidel it-trattament antipsikotiku, inkluż il-kura b'aripiprazole (ara sezzjoni 4.8).
English: ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
Maltese: ABILIFY 10 mg pilloli li jinħallu fil-ħalq: iron oxide aħmar (E 172)
English: The recommended initial dose for ABILIFY solution for injection is 9.75 mg (1.3 mL), administered as a single intramuscular injection.
Maltese: Id-doża tal-bidu rakkomandata għas-soluzzjoni ABILIFY għall-injezzjoni hi 9.75 mg (1.3 mL),
English: - The active substance is trastuzumab.
Maltese: - Is-sustanza attiva hi trastuzumab.
English: Overall Response Rate, %
Maltese: Rata ta' Rispons Globali, %
English: FP + H: Fluoropyrimidine/cisplatin + Trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
Maltese: FP + H: Fluoropyrimidine/cisplatin + Trastuzumab FP: Fluoropyrimidine/cisplatin a Proporzjon ta' probabbiltajiet
English: Observation N = 1697***
Maltese: Osservazzjoni N=1697***
English: Chemo + Trastuzumab (n = 115)
Maltese: Kimo + Trastuzumab (n = 115)
English: L-histidine hydrochloride
Maltese: L-histidine hydrochloride L-histidine
English: L-histidine hydrochloride, L-histidine, sorbitol, macrogol 3350, hydrochloric acid and sodium hydroxide.
Maltese: L-histidine hydrochloride, L-histidine, sorbitol, macrogol 3350, hydrochloric acid u sodium hydroxide.
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: Observation N = 1693
Maltese: Osservazzjoni N=1693
English: Special Economic Zone Plot Nos. 2, 3, 4 & 5 Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore
Maltese: Phase-IV-Bommasandra-Jigani Link Road-Bommasandra Post 560 099 Bangalore
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: Circulating shed HER2-ECD
Maltese: Shed HER2-ECD fiċ-ċirkolazzjoni
English: Influenza-like symptoms
Maltese: Sintomi simili tal-influwenza
English: Trastuzumab 1 Year N = 1702***
Maltese: Trastuzumab Sena Waħda N=1702***
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Maltese: Minoranza ta' pazjenti ġew ittestjati blużu ta' fluorescence in situ hybridisation (FISH).
English: Trastuzumab plus docetaxel4 N = 110
Maltese: Trastuzumab ma' docetaxel4 N=110
English: BGP Poducts ApS Tel: +45 28116932 (Danmark)
Maltese: BGP Products ApS Tel: +45 28116932 (Danmark)
English: Trastuzumab plus paclitaxel3 N = 32
Maltese: Trastuzumab ma' paclitaxel3 N=32
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: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 mcg/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 mcg/mL għallkostanti ta' Michaelis-Menten (Km - Michaelis-Menten constant) għall-pazjenti b'MBC, EBC, u AGC.
English: For monotherapy, the rate was 6 % - 9 %.
Maltese: Għall-monoterapija, ir-rata kienet ta' 6% - 9%.
English: Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH Parameter
Maltese: Tabella 10 Sommarju tal-analiżi tal-effikaċja BCIRG 006 AC→D kontra DCarbH Parametru
English: t1/2 range from Cmax,ss to Cmin,ss (day)
Maltese: Firxa ta' t1/2 minn Cmax, ss sa Cmin, ss (jum)
English: HR (95 % CI) p-value
Maltese: HR (CI ta' 95%) valur p
English: 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: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza * Fil-ħin tal-analiżi definittiva ta' DFS.
English: Ogivri contains sorbitol
Maltese: Ogivri fih sorbitol
English: Trastuzumab washout
Maltese: Jekk tieqaf tuża Ogivri
English: Total pathological complete response* (95 % CI)
Maltese: Rispons patoloġiku komplut totali* (CI ta' 95%)
English: Neutropenic sepsis
Maltese: Sepsis newtropenika
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: Trastuzumab plus paclitaxel2 N = 68
Maltese: Trastuzumab ma' paclitaxel2 N=68
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: Greater than 70 % of patients enrolled exhibited 3+ overexpression.
Maltese: Aktar minn 70% tal-pazjenti rreġistrati wrew espressjoni żejda ta' 3+.
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
English: Trastuzumab plus docetaxel3 N = 92
Maltese: Trastuzumab ma' docetaxel3 N=92
English: Table 12 Efficacy results from MO16432 Parameter
Maltese: Tabella 12 Riżultati tal-effikaċja minn MO16432
English: - The other ingredient(s) are L-histidine hydrochloride, L-histidine, Sorbitol (see section 2 “Ogivri contains sorbitol”), Macrogol 3350, Hydrochloric acid and Sodium hydroxide (for pH adjustment).
Maltese: - Is-sustanza(i) mhux attiva(i) l-oħra huma L-histidine hydrochloride, L-histidine, Sorbitol (ara section 2 “Ogivri fih sorbitol”), Macrogol 3350, Hydrochloric acid u Sodium hydroxide (għallaġġustament tal-pH).
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: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Maltese: Mediċini antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH Parameter
Maltese: Tabella 9 Sommarju tal-analiżi tal-effikaċja BCIRG 006 AC→D kontra AC→DH
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 għallpazjenti b'AGC.
English: No incompatibilities between Ogivri and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Maltese: Ma kinux osservati inkompatibilitajiet bejn Ogivri u boroż tal-polyvinylchloride, polyethylene jew polypropylene.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Maltese: N Firxa ta' CL totali minn Cmax, ss sa Cmin, ss (L/jum)
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 bi 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: AUCss, 0-21days (mcg.day/mL)
Maltese: AUCss, 0-21 jum (mcg.jum/mL)
English: Trastuzumab 1 Year N = 1693
Maltese: Trastuzumab Sena Waħda N=1693
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: 1 Studju WO16229: doża ogħla tal-bidu ta' 8 mg/kg, segwita minn kors ta' 6 mg/kg kull 3 ġimgħat 2 Studju MO16982: doża ogħla tal-bidu ta' 6 mg/kg fil-ġimgħa × 3; segwita minn kors ta' 6 mg/kg kull
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p = 0.004).
Maltese: Il-frekwenza ta' progressjoni fil-fwied kienet imnaqqsa b'mod sinifikanti fil-pazjenti kkurati bilkombinazzjoni ta' trastuzumab u paclitaxel, meta mqabbel ma' paclitaxel waħdu (21.8% kontra 45.7%, p=0.004).
English: Each 420 mg vial contains 322.6 mg sorbitol (E420).
Maltese: Kull kunjett ta' 420 mg fih 322.6 mg sorbitol (E420).
English: The population predicted PK exposure values (median with 5th - 95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (cycle 1), Table 15 (steadystate), and Table 16 (PK parameters).
Maltese: Il-valuri mbassra tal-esponiment PK tal-popolazzjoni (medjan b'5 - 95 Percentiles) u valuri talparametru PK f'konċentrazzjonijiet klinikament rilevanti (Cmax u Cmin) għall-pazjenti b'MBC, EBC u AGC ikkurati bil-korsijiet ta' dożaġġ q1w u q3w approvati huma murija fit-Tabella 14 (Ċiklu 1), Tabella 15 (stat fiss), u Tabella 16 (parametri PK).
English: Pulmonary fibrosis
Maltese: +Fibrożi pulmonari
English: In this section, the following categories of frequency have been used: 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: F'din is-sezzjoni, kienu wżati l-kategoriji ta' frekwenza li ġejjin: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tiġi stmata mid-dejta disponibbli).
English: Cmin (mcg/mL)
Maltese: N Cmin (mcg/mL)
English: Table 11 Post-Hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events
Maltese: Tabella 11 Riżultati tal-analiżi esploratorja post-hoc mill-analiżi konġunta tal-istudji kliniċi NSABP B-31/NCCTG N9831 u BCIRG006 li jikkombinaw avvenimenti ta' DFS u avvenimenti sintomatiċi tal-qalb
English: Ogivri contains the active substance trastuzumab, which is a monoclonal antibody.
Maltese: Ogivri fih is-sustanza attiva trastuzumab, li huwa antikorp monoklonali.
English: For the other parameters the improvements seen for the combination were for overall response (16.5 % versus 6.7 %); clinical benefit rate (42.7 % versus 27.9 %); time to progression (4.8 months versus 2.4 months).
Maltese: Għall-parametri l-oħra t-titjib li deher għall-kura kombinata kien għar-rispons globali (16.5% kontra 6.7%); rata ta' benefiċċju kliniku (42.7% kontra 27.9%); żmien sal-progressjoni (4.8 xhur kontra 2.4 xhur).
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %).
Maltese: L-ogħla rata ta' disfunzjoni kardijaka dehret f'pazjenti li kienu qed jirċievu trastuzumab flimkien ma' anthracycline/cyclophosphamide (27%), u kienet ogħla b'mod sinifikanti milli għal anthracycline/cyclophosphamide waħedhom (7% - 10%).
English: Response rate (95 %CI)
Maltese: Rata ta' rispons (CI ta' 95%)
English: In the pivotal trial MO16432, trastuzumab was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2).
Maltese: MO16432, trastuzumab ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha tliet ċikli ta' doxorubicin (doża kumulattiva ta' 180 mg/m²).
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH.
Maltese: Studji dwar ir-rati ta' posittività għal HER2 f'kanċer tal-istonku (GC - gastric cancer) bl-użu ta' immunoistokimika (IHCimmunohistochemistry) u fluorescence in situ hybridization (FISH) jew chromogenic in situ hybridization (CISH) urew li hemm varjazzjoni kbira fil-posittività għal HER2 li tvarja minn 6.8% sa 34.0% għal IHC u 7.1% sa 42.6% għal FISH.
English: Ogivri 420 mg contains 322.6 mg sorbitol in each vial.
Maltese: Ogivri 420 mg fih 322.6 mg sorbitol f'kull kunjett.
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2 % in patients receiving trastuzumab and docetaxel, compared with 0 % in patients receiving docetaxel alone.
Maltese: Fi prova sussegwenti b'sorveljanza prospettiva tal-funzjoni kardijaka, l-inċidenza ta' CHF sintomatika kienet ta' 2.2% f'pazjenti li rċevew trastuzumab u docetaxel, meta mqabbel ma' 0% fil-pazjenti li rċevew docetaxel waħdu.
English: A final analysis was performed after a median follow-up of 8 years, which showed that 1 year trastuzumab treatment is associated with a 24 % risk reduction compared to observation only (HR = 0.76, 95 % CI 0.67, 0.86).
Maltese: Twettqet analiżi finali wara segwitu medjan ta' 8 snin, li wriet li kura ta' sena waħda bi trastuzumab hija assoċjata ma' tnaqqis ta' 24% fir-riskju meta mqabbel ma' osservazzjoni biss (HR = 0.76, CI ta' 95% 0.67, 0.86).
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non-measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)].
Maltese: F'analiżi esploratorja tas-sottogrupp li saret fil-prova TOGA (BO18255) ma kien hemm l-ebda benefiċċju apparenti fuq is-sopravivenza globali biż-żieda ta' trastuzumab f'pazjenti b'marda ECOG PS 2 fil-linja bażi [HR 0.96 (CI ta' 95% 0.51-1.79)], li ma tistax titkejjel [HR 1.78 (CI ta' 95% 0.87-3.66)] u avvanzata lokalment [HR 1.20 (CI ta' 95% 0.29-4.97)].
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing System organ class
Maltese: Tabella 1 Effetti mhux mixtieqa rrappurtati bi trastuzumab fil-vini bħala monoterapija jew flimkien ma' kimoterapija fi provi kliniċi pivitali (N=8386) u wara t-tqegħid fis-suq Sistema tal-klassifika talorgani
English: AUC0-21days (mcg.day/mL)
Maltese: AUC0-21jum (mcg.jum/mL)
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Piż tal-ġisem (kg) × doża (8 mg/kg għad-doża ogħla tal-bidu jew 6 mg/kg għaddoża ta' manteniment) 21 (mg/mL, konċentrazzjoni ta' soluzzjoni rikostitwita)
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 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.
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Maltese: Dejta farmakokinetika minn studji BO15935 u M77004 fuq nisa b'MBC pożittiv għal HER2 issuġġeriet li esponiment għal paclitaxel u doxorubicin (u l-metaboliti prinċipali tagħhom 6-α hydroxyl-paclitaxel, POH, u doxorubicinol, DOL) ma kienx mibdul fil-preżenza ta' trastuzumab (doża għolja tal-bidu ta' 8 mg/kg jew ta' 4 mg/kg ġol-vini segwita minn 6 mg/kg q3w jew 2 mg/kg q1w ġolvini, rispettivament).
English: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37 % compared to approximately 1 % in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Maltese: F'wieħed mit3 studji pivitali mwettqa fejn kien disponibbli segwitu medjan ta' 5.5 snin (BCIRG006) kienet osservata żieda kontinwa fir-rata kumulattiva ta' avvenimenti kardijaċi sintomatiċi jew avvenimenti ta' LVEF sa 2.37% f'pazjenti li ngħataw trastuzumab flimkien ma' taxane wara terapija b'anthracycline meta mqabbel ma madwar 1% fiż-żewġ gruppi ta' paragun (anthracycline flimkien ma' cyclophosphamide segwit minn taxane u taxane, carboplatin u trastuzumab).
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.
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy; additionally, the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Maltese: L-istudji NSABP B-31 u NCCTG N9831 li jinkludu l-analiżi konġunta kienu maħsuba biex jinvestigaw l-utilità klinika li kura bi trastuzumab tingħata flimkien ma' paclitaxel wara kimoterapija AC; barra dan, l-istudju NCCTG N9831 investiga wkoll iż-żieda sekwenzjali ta' trastuzumab ma' kimoterapija AC→P f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija.
English: The efficacy results from study BO18225 are summarised in Table 13: Table 13 Efficacy results from BO18225
Maltese: Ir-riżultati tal-effikaċja minn studju BO18225 huma miġbura fil-qosor f'Tabella 13: Tabella 13 Riżultati tal-effikaċja minn BO18225