FrancophonIA/ELRC3.0 huggingface dataset:
English: • Introduction to the product: provide information on the contents of the box ie that 28 days treatment is 56 capsules and 1 device.
Maltese: • Introduzzjoni għall-prodott: jipprovdu informazzjoni dwar il-kontenut tal-kaxxa, i.e. li 28 jum ta'
English: When AUC 0-6 was adjusted by dose and body weight, a slightly higher AUC 0-6 /D/W for total CMS and total free colistin was observed in children.
Maltese: Meta AUC0-6 ġiet aġġustata skont id-doża u l-piż tal-ġisem, fit-tfal ġew osservati AUC0-6 /D/W kemmxejn ikbar għal CMS totali kif ukoll colistin totali ħieles.
English: Vpriv is a medicine that contains the active substance velaglucerase alfa.
Maltese: Vpriv huwa mediċina li fiha s-sustanza attiva velaglucerase alfa.
English: Why has Vpriv been approved?
Maltese: Għaliex ġie approvat Vpriv?
English: Other information about Vpriv
Maltese: Informazzjoni oħra dwar Vpriv
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vpriv is available on the Agency's website under EMA website/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Vpriv huwa disponibbli fis-sit elettroniku tal-Aġenzija taħt EMA website/Find medicine/Human medicines/Rare disease designations.
English: This document is a summary of the European public assessment report (EPAR) for Vpriv.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vpriv.
English: Vpriv was as effective as imiglucerase at reducing anaemia.
Maltese: Vpriv kien effettiv daqs imiglucerase fit-tnaqqis tal-anemija.
English: In one main study involving 35 patients (including 9 children) with type 1 Gaucher disease, Vpriv was compared with imiglucerase (another medicine for Gaucher disease).
Maltese: Fi studju ewlieni li involva 35 pazjent (inklużi 9 itfal) bil-marda ta' Gaucher tat-tip 1, Vpriv tqabbel ma' imiglucerase (mediċina oħra kontra l-marda ta' Gaucher).
English: The full EPAR for Vpriv can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Vpriv jinsab fis-sit elettroniku tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: The most serious side effects are hypersensitivity (allergic) reactions.
Maltese: L-effetti sekondarji l-aktar serji huma reazzjonijiet ta' ipersensittività (allerġija).
English: Vpriv increased the amount of haemoglobin (the protein in red blood cells that carries oxygen) by an average of 1.6 grams per decilitre (from 11.4 g/dl) while imiglucerase increased the amount of haemoglobin by an average of 1.5 g/dl (from 10.6 g/dl).
Maltese: Vpriv żied l-ammont ta' emoglobina (ilproteina fiċ-ċelloli ħomor tad-demm li ġġorr l-ossiġnu) b'medja ta' 1.6 grammi għal kull deċilitru (minn 11.4 g/dl) filwaqt li l-imiglucerase żied l-ammont ta' emoglobina b'medja ta' 1.5 g/dl (minn 10.6 g/dl).
English: What is Vpriv?
Maltese: Kif jintuża Vpriv?
English: The most common side effects with Vpriv (seen in more than 1 patient in 10) are infusion-related reactions, which include headache, dizziness, hypotension (low blood pressure), hypertension (high blood pressure), nausea (feeling sick), asthenia (weakness) or fatigue (tiredness), and pyrexia (fever) or increased body temperature.
Maltese: L-effetti sekondarji l-aktar komuni b'Vpriv (li dehru f'aktar minn pazjent 1 minn kull 10) huma reazzjonijiet relatati mal-infużjoni, li jinkludu wġigħ ta' ras, sturdament, ipotensjoni (pressjoni taddemm baxxa, ipertensjoni (pressjoni tad-demm għolja), nawżja (tħossok ma tiflaħx), astenija (dgħjufija) jew għeja, u piressija (deni) jew żieda fit-temperatura tal-ġisem.
English: Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called glucocerebrosidase, which normally breaks down a fat called glucocerebroside.
Maltese: Il-marda Gaucher hija disturb rari li jintiret, li fiha persuna ma jkollhiex biżżejjed mill-enzima msejħa glucocerebrosidase, li normalment tkisser xaħam imsejjaħ glucocerebroside.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vpriv on 26 August 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vpriv fis-26 ta' Awwissu 2010.
English: Without the enzyme, glucocerebroside builds up in the body, typically in the liver, spleen and bone, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Maltese: Mingħajr l-enzima, il-glucocerebroside takkumula fil-ġisem, normalment fil-fwied, fil-milsa u fl-għadam, u dan jipproduċi s-sintomi tal-marda: anemija (għadd baxx ta' ċelloli tad-demm ħomor), għeja, tbenġil ta' malajr u tendenza ta' fsada, żieda fid-daqs talmilsa u tal-fwied, u wġigħ u ksur bl-għadam
English: Because the number of patients with Gaucher disease is low, the disease is considered ‘rare', and Vpriv was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 June 2010.
Maltese: Billi l-għadd ta' pazjenti bil-marda ta' Gaucher huwa wieħed baxx, il-marda hija kkunsidrata ‘rari', u Vpriv kien ikklassifikat bħala ‘mediċina orfni' (mediċina użata għal mard rari) fid-9 ta' Ġunju 2010.
English: It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Jiġi bħala trab li jintgħamel f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: What is the risk associated with Vpriv?
Maltese: X'inhu r-riskju assoċjat ma' Vpriv?
English: The recommended dose of Vpriv is 60 units/kg bodyweight, which is given as a one-hour infusion once every two weeks.
Maltese: Id-doża rakkomandata ta' Vpriv hija 60 unità/kg ta' piż tal-ġisem, li tingħata bħala infużjoni li ddum siegħa darba kull ġimagħtejn.
English: How does Vpriv work?
Maltese: Kif ġie studjat Vpriv?
English: Gaucher disease occurs because of the lack of an enzyme called glucocerebrosidase.
Maltese: Il-marda ta' Gaucher isseħħ minħabba n-nuqqas ta' enzima msejħa glucocerebrosidase.
English: Velaglucerase alfa replaces the missing enzyme in Gaucher disease, helping to break down glucocerebroside and stopping it building up in the body.
Maltese: Vpriv ma għandux jintuża fuq pazjenti li jkollhom reazzjoni allerġika severa għal velaglucerase alfa jew għal kwalunkwe wieħed mill-ingredjenti l-oħra.
English: The study also showed that Vpriv is as effective as imiglucerase in controlling other signs of Gaucher disease.
Maltese: L-istudju wera wkoll li Vpriv kien effettiv daqs l-imigluċerase fil-kontroll ta' sintomi oħra tal-marda ta' Gaucher.
English: Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Ontruzant.
Maltese: Dawn jinkludu dgħufija tal-muskolu tal-qalb li tista' twassal għal insuffiċjenza tal-qalb, infjammazzjoni tal-kisja ta' madwar il-qalb u disturbi fir-ritmu tal-qalb.
English: Chemo + trastuzumab (n=115)
Maltese: Kimo +trastuzumab (n=115)
English: AUCss, 0-21 days
Maltese: AUCss, 0-21 jum
English: FP + H: fluoropyrimidine/cisplatin + trastuzumab FP: fluoropyrimidine/cisplatin a Odds ratio
Maltese: FP + H: fluoropyrimidine/cisplatin + trastuzumab FP: fluoropyrimidine/cisplatin a Proporzjon ta' periklu
English: EU/1/17/1241/001 EU/1/17/1241/002
Maltese: EU/1/17/1241/002
English: Infusion-related reactions (IRRs) and hypersensitivity
Maltese: Reazzjonijiet relatati mal-infużjoni (IRRs-infusion-related reactions) u sensittività eċċessiva
English: Volume (mL) =
Maltese: Volum (mL) =
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' avvenimenti avversi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2017
English: t1/2 range from Cmax,ss to
Maltese: Firxa ta' t1/2 minn Cmax,ss to
English: A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Maltese: Minoranza ta' pazjenti ġew ittestjati bl-użu ta' fluorescence in-situ hybridisation (FISH).
English: * Observed with combination therapy following anthracyclines and combined with taxanes
Maltese: * Osservat b'terapija kombinata wara anthracyclines u flimkien ma' taxanes.
English: Table 13 Efficacy results from BO18225 Parameter
Maltese: Tabella 13 Riżultati tal-effikaċja minn BO18225
English: Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC2+/FISH+ or IHC3+).
Maltese: Analiżi post-hoc ta' sottogruppi tindika li effetti pożittivi tal-kura huma limitati biex jolqtu tumuri b'livelli ogħla tal-proteina HER2 (IHC2+/FISH+ jew IHC3+).
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) u ta' 8.92 µg/mL għall-kostanti ta' Michaelis-Menten (Km) għall-pazjenti b'MBC, EBC, u AGC.
English: Trastuzumab plus docetaxel4 N=110
Maltese: Trastuzumab flimkien ma' docetaxel4 N=110
English: Clinical experience is limited in patients above 65 years of age.
Maltese: Esperjenza klinika f'pazjenti b'età 'l fuq minn 65 sena hija limitata.
English: For monotherapy, the rate was 6%-9%.
Maltese: Għall-monoterapija, ir-rata kienet ta' 6%-9%.
English: Trastuzumab 1 Year N=1702***
Maltese: N=1702***
English: Olof Palmestraat 10, 2616 LR Delft
Maltese: Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft L-Olanda
English: Trastuzumab washout
Maltese: Jekk tieqaf tuża Ontruzant
English: Study H0649g: IHC3+ patient subset
Maltese: Studju H0649g: sotto-sett ta' pazjenti IHC3+ Studju H0648g: sotto-sett ta' pazjenti IHC3+
English: SISH technology is however, recommended to allow for the parallel evaluation of tumor histology and morphology.
Maltese: Madankollu teknoloġja SISH hija rakkomandata biex tippermetti l-valutazzjoni parallella tal istoloġija u l-morfoloġija tat-tumur.
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
English: • The active substance is trastuzumab.
Maltese: X'fih Ontruzant • Is-sustanza attiva hi trastuzumab.
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH
Maltese: Tabella 9 Sommarju tal-Analiżi tal-Effikaċja ta' BCIRG 006 AC→D kontra AC→DH
English: Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal 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'
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, segwita minn kors ta' 6 mg/kg kull 3 ġimgħat
English: Total pathological complete response* (95% CI)
Maltese: Rispons patoloġiku kompluttotali* (CI ta' 95 %)
English: Trastuzumab plus docetaxel3 N=92
Maltese: Trastuzumab u docetaxel3 N=92
English: Death (OS event): No. patients with event p=0.014**
Maltese: Mewt (avveniment OS): Numru ta' pazjenti bl-avveniment p=0.014**
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 b'trastuzumab.
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 għallpazjenti b'MBC u EBC u ta' 3.63 L għall-pazjenti b'AGC.
English: HER2 gene amplification should be detected using fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) of fixed tumour blocks.
Maltese: (FISH) jew chromogenic in situ hybridisation (CISH) ta' blokki fissi tat-tumur.
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: Ontruzant is given as an infusion into a vein (intravenous infusion, “drip”).
Maltese: Ontruzant jingħata bħala infużjoni ġo vina (infużjoni ġol-vini, “dripp”).
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Maltese: Proporzjonijiet ta' periklu DFS (CI ta' 95 %) valur p p<0.0001
English: No. patients with event p=0.0555
Maltese: Numru ta' pazjenti bl-avveniment p=0.0555
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: ċitotossiċità medjata miċ-ċelluli dipendenti minn antikorpi (ADCC - antibody-dependent cellmediated cytotoxicity).
English: Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody.
Maltese: Ontruzant fih is-sustanza attiva trastuzumab, li huwa antikorp monoklonali.
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
English: In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95% CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value=0.78].
Maltese: [DFS HR fil-popolazzjoni b'intenzjoni li jiġu kkurati (ITTintent to treat) ta' sentejn kontra sena waħda=0.99 (CI ta' 95%: 0.87, 1.13), valur p=0.90 u OS HR=0.98 (0.83, 1.15); valur p= 0.78].
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għal trastuzumab, proteini tal-ġrieden, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Total CL range from Cmax,ss to Cmin,ss
Maltese: Firxa ta' CL totali minn Cmax,ss sa
English: FP +H N=294 HR (95% CI)
Maltese: FP +H N=294
English: At the time of the analysis a total of 349 randomized patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Maltese: Fiż-żmien tal-analiżi total ta' 349 pazjent li kienu randomized mietu: 182 pazjent (62.8%) fil-grupp ta' kontroll u 167 pazjent (56.8%) fil grupp ta' kura.
English: • Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, which was followed by Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Maltese: • Doxorubicin 60 mg/m2 u paclitaxel 150 mg/m2, mogħtija darba kull 3 ġimgħat għal
English: No. patients with event p=0.0275
Maltese: Numru ta' pazjenti bl-avveniment p=0.0275
English: In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Maltese: mard tal-interstizju tal-pulmun inkluż infiltrati fil-pulmun, sindrome ta' distress respiratorju akut, pnewmonja, pulmonite, effużjoni fil-plewra, distress respiratorju, edima pulmonari akuta, u insuffiċjenza respiratorja.
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: Segwitu fit-tul** proporzjonijiet ta' periklu (CI ta' 95 %) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza
English: Hazard ratio (95% CI)
Maltese: HR (95% CI)
English: The reconstituted Ontruzant solution contains 21 mg/mL of trastuzumab.
Maltese: Is-soluzzjoni rikostitwita ta' Ontruzant fiha 21 mg/mL ta' trastuzumab.
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%), ukienet ogħla b'mod sinifikanti milli għal anthracycline/cyclophosphamide waħedhom (7% - 10%).
English: Trastuzumab plus paclitaxel3 N=32
Maltese: Trastuzumab flimkien ma' docetaxel3 N=32
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC3+/FISH+ group.
Maltese: Għas-sopravivenza globali,HR kien ta' 0.75 (CI ta' 95% 0.51-1.11) fil-grupp ta' IHC2+/FISH+ u HR kien ta' 0.58 (CI ta' 95%0.
English: A study of trehalose, a major formulation excipient, did not reveal any toxicities.
Maltese: Studju dwar trehalose, eċċipjent maġġuri fil-formulazzjoni, ma wera l-ebda tossiċità.
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 b'trastuzumab tingħata flimkien ma' paclitaxel warakimoterapija 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: In a method comparison study (study D008548) a high degree of concordance (>95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Maltese: Fi studju li pparaguna l-metodu (studju D008548) kien osservat grad għoli ta' konkordanza (>95%) għal tekniki SISH u FISH għall-osservazzjoni tal-amplifikazzjoni tal-ġene HER2 f'pazjenti b'kanċer tal-istonku.
English: The median overall survival for the high HER2-expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51-0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51-0.79) for FP versus FP + H, respectively.
Maltese: Is-sopravivienza globali medjana għall-grupp b'espressjoni għolja ta' HER2 kienet ta' 11.8 xhur kontra 16-il xahar, HR 0.65 (CI ta'95% 0.51-0.83) u is-sopravivenza mingħajr progressjoni medjana kienet ta' 5.5 xhur kontra 7.6 xhur, HR 0.64 (CI ta' 95% 0.51-0.79) għal FP kontra FP + H, rispettivament.
English: Chemo only (n=116)
Maltese: (n=116)
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: stratifikat=0.64; CI ta' 95% [0.55, 0.74]; valur p log-rank < 0.0001).
English: The updated DFS analysis results (stratified HR = 0.61; 95% CI [0.54, 0.69]) showed a similar DFS benefit compared to the definitive primary DFS analysis, despite the 24.8% patients in the AC→P arm who crossed over to receive trastuzumab.
Maltese: Ir-riżultati aġġornati tal-analiżi ta' DFS (HR stratifikat = 0.61; CI ta' 95% [0.54, 0.69]) urew benefiċċju ta' DFS simili meta mqabbla mal-analiżi primarja definittiva ta' DFS, minkejja li 24.8% tal-pazjenti fil-grupp ta' AC→P qalbu biex jirċievu trastuzumab.
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Maltese: • Is-sustanza(i) mhux attivi l-oħra huma L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
English: Table 4 Efficacy results from the monotherapy and combination therapy studies Parameter
Maltese: Tabella 4 Riżultati tal-effikaċja mill-istudji ta' monoterapija u ta' terapija kombinata Parametru
English: Study MO16419
Maltese: Studju BO15935 Studju MO16419
English: More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6% versus 6.5%; p=0.377).
Maltese: Numru akbar ta' pazjenti kkurati b'trastuzumab u paclitaxel kellhom progressjoni fis sistema nervuża ċentrali minn dawk ikkurati b'paclitaxel waħdu (12.6% kontra 6.5%, p=0.377).
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) >25 kg/m2.
Maltese: F'pazjenti li qed jirċievu trastuzumab wara li tkun kompluta kimoterapija awżiljarja, ir-riskju ta' disfunzjoni kardijaka kienet assoċjata ma' doża kumulattiva ogħla ta' anthracycline mogħti qabel il-bidu ta' trastuzumab u indiċi tal-massa tal-ġisem (BMI - body mass index) ta' >25 kg/m2.
English: Death (OS event) No. patients with event p=0.0182
Maltese: Mewt (avveniment ta' OS): Numru ta' pazjenti bl-avveniment p=0.0182
English: Other medicines and Ontruzant
Maltese: Mediċini oħra u Ontruzant
English: - capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Maltese: - capecitabine - 1000 mg/m2 orali darbtejn kuljum għal 14-il ġurnata kull 3 ġimgħat għal 6 ċikli
English: 150 mg vial
Maltese: Il-kunjett fih 150 mg trastuzumab.
English: No incompatibilities between Ontruzant and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Maltese: Ma ġew osservati l-ebda inkompatibilitajiet bejn Ontruzant u boroż tal-polyvinylchloride, tal polyethylene jew tal-polypropylene.
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially after a taxane (0.3-0.4%).
Maltese: Fi 3 provi kliniċi pivitali b'trastuzumab mogħti b'mod awżiljarju flimkien ma' kimoterapija, linċidenza ta' disfunzjoni kardijaka ta' grad 3/4 (b'mod speċifiku Insuffiċjenza Konġestiva tal-Qalb sintomatika) kienet simili f'pazjenti li ngħataw kimoterapija waħedha (jiġifieri ma rċevewx trastuzumab) u f'pazjenti li ngħataw trastuzumab b'mod sekwenzjali wara taxane (0.3-0.4 %).
English: Mechanism of action Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Maltese: Trastuzumab jeħel b'affinità u speċifiċità għolja mas-sotto-dominju IV, reġjun juxta-membranu tad-dominju ekstraċellulari ta' HER2.