FrancophonIA/ELRC3.0 huggingface dataset:
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95% CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8% versus 78.2%) in favour of the trastuzumab arm.
Maltese: Wara segwitu medjan ta' 12-il xahar, il-proporzjon ta' periklu (HR - hazard ratio) għas-sopravivenza mingħajr ilmarda (DFS - disease free survival) kien ta' 0.54 (CI ta' 95 % 0.44, 0.67) li huwa definit bħala benefiċċju assolut, f'termini ta' rata ta' sopravivenza mingħajr il-marda ta' sentejn, ta' 7.6 punti perċentwali (85.8 % kontra 78.2 %) favur il-grupp ikkurat bi trastuzumab.
English: Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Maltese: It-tul medjan ta' segwitu fit-tul għall-istudju BCIRG 006 kien ta' 10.3 snin kemm fil-grupp ta' AC→D (firxa: 0.0 sa 12.6) kif ukoll fil-grupp ta' DCarbH (firxa: 0.0 sa 13.1), u kien ta' 10.4 snin (firxa: 0.0 sa 12.7) fil-grupp ta' AC→DH
English: Discard by:
Maltese: Tabella 7:
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Maltese: • Għandek kanċer metastatiku tal-istonku b'livelli għolja ta' HER2, fejn jiġi kombinat malmediċini l-oħra għall-kanċer capecitabine jew 5-flououracil u cisplatin.
English: Each 420 mg vial of Trazimera is reconstituted with 20 mL of sterile water for injections (not supplied).
Maltese: Kull kunjett ta' 420 mg ta' Trazimera huwa rikostitwit b'20 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Maltese: Id-dejta tindika li effetti tajbin kienu akbar fost dawk ilpazjenti b'livelli ogħla ta' espressjoni żejda ta' HER2 (3+).
English: Supraventricular tachyarrhythmia
Maltese: Taki-arritmija supraventrikolari
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Maltese: Dan jagħti 20.6 mL ta' soluzzjoni għal doża waħda biss, li fih madwar 21 mg/mL ta' trastuzumab.
English: Patients treated with Trazimera are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Maltese: Pazjenti kkurati bi Trazimera huma f'riskju akbar għall-iżvilupp ta' CHF (New York Heart Association [NYHA] Klassi
English: The efficacy results from the BCIRG 006 are summarized in Tables 9 and 10.
Maltese: Ir-riżultati tal-effikaċja minn BCIRG 006 huma miġbura fil-qosor f'Tabelli 9 u 10.
English: - intravenous push doxorubicin, at 60 mg/m 2, given every 3 weeks for 4 cycles.
Maltese: doxorubicin push fil-vini, b'doża ta' 60 mg/m 2, mogħti kull 3 ġimgħat għal 4 ċikli.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Maltese: Dejjem żomm din il-mediċina fil-pakkett oriġinali magħluq f temperatura ta' 2°C - 8 °C fil-friġġ.
English: Table 15 Population Predicted Steady State PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients
Maltese: Tabella 15 Valuri Mbassra tal-Esponiment PK tal-Popolazzjoni fi Stat Fiss (medjan b'595
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 (ITT - intent 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]. Ir-rata ta' disfunzjoni kardijaka mingħajr sintomi żdiedet fil-grupp ta' kura ta' sentejn (8.1 % kontra 4.6 % fil-grupp ta' kura ta' sena waħda).
English: Thrombocytopenia
Maltese: Trazimera kunjett
English: Hazard Ratio vs AC→D (95% CI)
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95 %)
English: N=77
Maltese: Paclitaxel N=77
English: Table 14 Population Predicted Cycle 1 PK Exposure Values (median with 5th - 95th Percentiles) for Trastuzumab Intravenous Dosing Regimens in MBC, EBC and AGC Patients Regimen
Maltese: Tabella 14 Valuri Mbassra tal-Esponiment PK tal-Popolazzjoni ta' Ċiklu 1 (medjan b'595
English: If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Maltese: Jekk lewwel doża tkun ittollerata sew id-dożi ta' wara jistgħu jingħataw fuq perjodu ta' 30 minuta (ara sezzjoni 2 taħt “Twissijiet u prekawzjonijiet”).
English: Tel: +385 1 3908 777
Maltese: T : +357 22 817690
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4).
Maltese: Sinjali u sintomi ta' disfunzjoni kardijaka bħal qtugħ ta' nifs, qtugħ ta' nifs waqt li wieħed ikun mindud, żieda fis-sogħla, edima pulmonari, gallop S3, jew porzjon imbuttat 'il barra mill-ventriklu imnaqqsa, ikunu osservati f'pazjenti kkurati bi trastuzumab (ara sezzjoni 4.4).
English: The median duration of follow up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Maltese: It-tul medjan ta' segwitu kien ta' 2.9 snin fil-grupp AC→D u ta' 3.0 snin fil-gruppi AC→DH u DCarbH.
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Maltese: Fl-istudju BCIRG 006 għall-punt finali primarju, DFS, il-proporzjon ta' periklu jittraduċi f'benefiċċju assolut, f'termini ta' stimi ta' rata ta' sopravivenza mingħajr il-marda ta' 3 snin ta' 5.8 punti perċentwali (86.7 % kontra 80.
English: There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies.
Maltese: Ma kien hemm l-ebda evidenza ta' effett tossiku akut jew relatat ma' dożi multipli fi studji li damu sa 6 xhur, jew fi studji dwar l-effett tossiku fuq is-sistema riproduttiva fit-teratoloġija, fertilità femminili jew effett tossiku fl-aħħar tal-ġestazzjoni/trasferiment mill-plaċenta.
English: Trazimera is a powder for concentrate for solution for infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab.
Maltese: Trazimera huwa trab għal konċentrat għall-soluzzjoni għall-infużjoni, li huwa disponibbli f'kunjett talħġieġ b'tapp tal-lastku li fih jew 150 mg jew 420 mg ta' trastuzumab.
English: Immune thrombocytopenia
Maltese: • infjammazzjoni jew ċikatriċi fil-pulmun
English: • anaphylactic reactions
Maltese: • reazzjonijiet allerġiċi
English: • haemorrhoids
Maltese: • suffejra
English: • itchy rash
Maltese: • għaraq
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Maltese: Ir-rata kienet l-ogħla f'pazjenti li ngħataw trastuzumab flimkien ma' taxane (2.0 %).
English: Rhinitis
Maltese: Ansjetà
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 8 below:
Maltese: Ir-riżultati finali ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 huma miġbura fil-qosor f'Tabella 8 taħt:
English: Children and adolescents Trazimera is not recommended for anyone under the age of 18 years.
Maltese: Tfal u adolexxenti Trazimera mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Maltese: Id-doża ogħla tal-bidu għandha tingħata bħala infużjoni fil-vini fuq medda ta' 90 minuta.
English: Not known: frequency cannot be estimated from the available data
Maltese: Mhux magħruf: frekwenza ma tistax tiġi stmata mid-dejta disponibbli
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Maltese: Reattività qawwija, kompluta, bażolaterali jew laterali filmembrana f ≥ 10 % taċ-ċelluli tat-tumur.
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 f'100
English: • muscle pain
Maltese: • uġigħ fil -muskoli
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Maltese: Dan jagħti 7.4 mL ta' soluzzjoni għal doża waħda biss, li fih madwar 21 mg/mL ta' trastuzumab.
English: Do not administer as an intravenous push or bolus.
Maltese: Tagħtix bħala push jew bolus fil-vini.
English: • muscle weakness
Maltese: • dgħufija muskolari
English: Wheezing
Maltese: Rinite
English: Trastuzumab
Maltese: Pożoloġija
English: Docetaxel
Maltese: Stitikezza
English: • infection of lungs
Maltese: • infezzjoni fil-pulmun
English: Trazimera 150 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Trazimera 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Maltese: Iż-żieda ta' trastuzumab ma' kimoterapija b'paclitaxel irriżultat ukoll fi tnaqqis ta' 37 % fir-riskju ta' mewt.
English: Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events.
Maltese: Pazjenti li jkollhom qtugħ ta' nifs waqt li mistrieħa minħabba komplikazzjonijiet ta' tumur malinn avanzat u ta' mard ieħor fl-istess waqt jistgħu jkunu f'riskju akbar ta' avvenimenti pulmonari.
English: Distant recurrence No. patients with event p<0.0001
Maltese: Numru ta' pazjenti blavveniment p<0.0001
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Maltese: 1 % (30/296) tal-pazjenti kkurati bi trastuzumab fil-vini żviluppaw antikorpi kontra trastuzumab.
English: - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Maltese: flimkien ma' kimoterapija awżiljarja li tikkonsisti minn docetaxel u carboplatin.
English: Subsequent Trazimera maintenance doses (weekly regimen:2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Maltese: 6 mg/kg, rispettivament) għandhom jingħataw 7 ijiem jew 21 jum wara skont il-programmi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: PFIZER EΛΛAΣ A.E. (CYPRUS BRANCH) T : +357 22 817690
Maltese: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
Maltese: III u IV) fil-grupp ta' kura bi trastuzumab għal sena waħda kienet ta' 0.8 %, u r-rata ta' disfunzjoni ħafifa talventrikolu tax-xellug bis-sintomi u bla sintomi kienet ta' 4.6 %.
English: Trazimera and anthracyclines should not be given concurrently in combination in the MBC setting.
Maltese: Trazimera u anthracyclines m'għandhomx jingħataw fl-istess waqt flimkien f'sitwazzjoni ta' MBC.
English: Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Maltese: Riżultati tal-Effikaċja mill-Istudji Mhux Komparattivi ta' Monoterapija u ta' Terapija Kombinata
English: Pyrexia
Maltese: Ipoxja
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensinconverting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Maltese: Jekk tiżviluppa insuffiċjenza sintomatika tal-qalb waqt terapija bi Trazimera, għandha tiġi kkurata bi prodotti mediċinali standard għal CHF. Il-biċca l-kbira tal-pazjenti li żviluppaw CHF jew disfunzjoni kardijaka bla sintomi fil-provi pivitali marru għall-aħjar b'kura standard għal CHF li tikkonsisti minn inibitur tal-enzima li tittrasforma lill-angiotensin (ACE - angiotensin-converting enzyme) jew imblokkatur tar-riċettur ta' angiotensin (ARB - angiotensin receptor blocker) u imblokkatur tarriċetturi beta.
English: Each carton contains 1 vial of powder.
Maltese: Kura kombinata bi trastuzumab u anastrozole
English: An overfill of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Maltese: Mili żejjed ta' 4 % jiżgura li d-doża mmarkata ta' 150 mg tkun tista' tittella' minn kull kunjett.
English: - The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
Maltese: - Is-soluzzjoni li tirriżulta fiha madwar 21 mg/mL trastuzumab.Is-sustanza(i) l-oħra huma Lhistidine hydrochloride monohydrate, L-histidine, sucrose, polysorbate 20.
English: B. PACKAGE LEAFLET
Maltese: Valur p kontra Osservazzjoni
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events.
Maltese: Il-maġġoranza tal-pazjenti b'sintomi kardijaċi u b'evidenza ta' benefiċċju kliniku ta' kura bi trastuzumab komplew fuq it-terapija mingħajr aktar avvenimenti kardijaċi kliniċi.
English: Acute respiratory distress syndrome
Maltese: Sindrome ta' distress respiratorju akut Mhux magħruf Bronkospażmu
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Maltese: reazzjonijiet relatati mal-infużjoni, tossiċità ematoloġika (b'mod partikolari newtropenija), infezzjonijiet u reazzjonijiet pulmonari avversi.
English: 0-21days
Maltese: 1Rogħda
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster nonlinear clearance (lower Km) (P < 0.001).
Maltese: L-analiżi esploratorja ta' kovarjabbli b'informazzjoni f'sottogrupp ta' pazjenti biss issuġġeriet li pazjenti b'livell ogħla ta' shed HER2-ECD kellhom tneħħija mhux lineari aktar malajr (Km aktar baxxa) (P < 0.001).
English: • you suffer from breathlessness, especially if you are currently using a taxane.
Maltese: • tbati minn qtugħ ta' nifs, speċjalment jekk bħalissa qed tuża taxane.
English: N=94
Maltese: Docetaxel N=94
English: - intravenous paclitaxel - 80 mg/m 2 as a continuous intravenous infusion, given every week for
Maltese: paclitaxel fil-vini - 80 mg/m 2 bħala infużjoni kontinwa fil -vini, mogħti kull ġimgħa għal
English: Regimen
Maltese: Republika
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Trazimera, or longer if a continuous decrease of LVEF is observed.
Maltese: F'pazjenti li jirċievu kimoterapija li fiha anthracycline huwa rakkomandat aktar monitoraġġ, u dan għandu jseħħ kull sena sa 5 snin wara l-aħħar għoti ta' Trazimera, jew aktar jekk jiġi osservat tnaqqis kontinwu ta' LVEF.
English: 30 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Maltese: Kunjett ta' 30 mL magħmul minn ħġieġ ċar tip I b'tapp tal-gomma butyl laminat b'kisja ta' fluororesin li fih 420 mg ta' trastuzumab.
English: - Keep this leaflet.
Maltese: Proporzjoni ta' Periklu kontra Osservazzjoni
English: 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Maltese: Kunjett ta' 15 mL magħmul minn ħġieġ ċar tip I b'tapp tal-gomma butyl laminat b'kisja ta' fluoro- resin li fih 150 mg ta' trastuzumab.
English: Hazard Ratio vs AC→D (95% CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95 %) valur p
English: A study conducted in lactating Cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg trastuzumab intravenous formulation demonstrated that trastuzumab is secreted in the milk.
Maltese: Twettqu studji dwar ir-riproduzzjoni f'xadini Cynomolgus b'dożi sa 25 darba aktar mid-doża ta' manteniment ta' kull ġimgħa għall-bnedmin, ta' 2 mg/kg ta' formulazzjoni għall-għoti fil-vini ta' trastuzumab, u ma żvelaw l-ebda evidenza ta' tnaqqis fil-fertilità jew ħsara lill-fetu.
English: An overfill of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Maltese: Mili żejjed ta' 5% jiżgura li d-doża mmarkata ta' 420 mg tkun tista' tittella' minn kull kunjett.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
Maltese: B'mod ġenerali, CISH huwa kkunsidrat pożittiv jekk ikun hemm aktar minn 5 kopji tal-ġene HER2 f'kull nukleu f'aktar minn 50% taċ-ċelluli tat-tumur.
English: • nausea
Maltese: • murliti
English: Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Maltese: Huwa meħtieġ ittestjar għal HER2 qabel tinbeda t-terapija (ara sezzjonijiet 4.4 u 5.1).
English: In general, SISH or FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2.
Maltese: B'mod ġenerali, SISH jew FISH huwa kkunsidrat pożittiv jekk il-proporzjon tan-numru tal-kopji talġene HER2 f'kull ċellula tat-tumur għan-numru ta' kopji ta' kromosoma 17 huwa daqs jew akbar minn 2.
English: In the BCIRG 006 study trastuzumab was administered either in combination with docetaxel, following AC chemotherapy (AC→DH) or in combination with docetaxel and carboplatin (DCarbH).
Maltese: Fl-istudju BCIRG 006 trastuzumab ingħata flimkien ma' docetaxel, wara kimoterapija b'AC (AC→DH) jew flimkien ma' docetaxel u carboplatin (DCarbH).
English: Heart beat irregular
Maltese: Taħbit tal-qalb irregolari
English: One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by chromatography including specific viral inactivation and removal procedures.
Maltese: IgG1 umanizzat magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju tal-ħamster Ċiniż) u ppurifikat permezz ta' kromatografija inkluż proċeduri speċifiċi ta' inattivazzjoni u tneħħija virali.
English: This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, and palpitations (heart fluttering or irregular heart beat) (see section 2 under “Heart checks”).
Maltese: Dan jista' jwassal għal sintomi bħal qtugħ ta' nifs (inkluż qtugħ ta' nifs billejl), sogħla, żamma ta' fluwidu (nefħa) fir-riġlejn jew fid-dirgħajn, palpitazzjonijiet (ritmu mhux normali tal-qalb jew taħbit irregolari tal-qalb) (ara 2.
English: Median Survival (months) (95% CI)
Maltese: Sopravivenza medjana (xhur) (CI ta' 95 %)
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Maltese: Perjodu biex Trastuzumab jiġi eliminat kompletament Il-perjodu biex Trastuzumab jiġi eliminat kompletament kien evalwat wara għoti q1w jew q3w fil-vini bl-użu tal-mudell PK tal-popolazzjoni.
English: Lip swelling
Maltese: Ż-ŻGĦAR EWLENIN
English: Patients classified as staining 2+ or 3+ were included, while those staining 0 or 1+ were excluded.
Maltese: Kienu inklużi pazjenti kklassifikati bħala b'tebgħat 2+ jew 3+, waqt li dawk b'tebgħat 0 jew 1+ kienu esklużi.
English: Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Maltese: Huwa stmat li madwar 40% tal-pazjenti kkurati bi trastuzumab ikollhom xi forma ta' reazzjoni relatata mal-infużjoni.
English: Appropriate aseptic technique should be used.
Maltese: Għandha tintuża teknika asettika adattata.
English: Trazimera vial
Maltese: X'fih Trazimera
English: Use of other reconstitution solvents should be avoided.
Maltese: L-użu ta' solventi oħra għar-rikostituzzjoni għandu jiġi evitat.
English: In vitro, trastuzumabmediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Maltese: In vitro, ADCC medjata minn trastuzumab intweriet li taħdem bi preferenza fuq ċelluli tal-kanċer li jagħmlu ammont eċċessiv ta' HER2 meta mqabbla ma' ċelluli tal-kanċer li ma jagħmlux ammont eċċessiv ta' HER2.
English: Pregnancy
Maltese: Disġewżja
English: Content Concentration
Maltese: Kontenut Konċentrazzjoni
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU)
English: 12 (3 x 4) singledose kits (1 vial + 1 pre-filled syringe + 1 vial connector + 2 needles) (multipack)
Maltese: 12 (3 x 4)-il kitt ta' doża waħda (kunjett 1 + siringa mimlija għal-lest 1 + konnettur tal-kunjett 1 + 2 labriet) (pakkett multiplu)
English: 12 (3 x 4) prefilled pens (multipack)
Maltese: 12 (3 x 4)-il pinna mimlija għal-lest (pakkett multiplu)
English: 12 (3 x 4) prefilled pens + 3 needles (multipack)
Maltese: 12 (3 x 4)-il pinna mimlija għal-lest + 3 labriet (pakkett multiplu)
English: 4 single-dose kits (1 vial + 1 prefilled syringe + 1 vial connector + 2 needles)
Maltese: 4 kitts ta' doża waħda (kunjett 1 + siringa mimlija għal-lest 1 + konnettur talkunjett 1 + 2 labriet)
English: 4 pre-filled pens + 1 needle
Maltese: 4 pinen mimljin għal-lest + labra 1
English: 11 April 2012
Maltese: 11 ta' April 2012
English: It contains the active substance capsaicin (8%).
Maltese: Fih is-sustanza attiva kapsajkina (8%).
English: The application was withdrawn after ‘day 90'.
Maltese: L-applikazzjoni ġiet irtirata wara ‘jum 90'.
English: The full European Public Assessment Report for Qutenza can found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Qutenza?
Maltese: X'inhu Qutenza?
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ‘selective agonist' of the ‘transient receptor potential vanilloid 1' (TRPV1) receptor.
Maltese: Is-sustanza attiva f'Qutenza, il-kapsajkina, hija sustanza li normalment tinstab fil-bżar aħmar li hija ‘agonista selettiva' tar-riċettur ‘riċettur temporanju potenzjali vanilloid 1' (transient receptor potential vanilloid 1 - (TRPV1)).
English: The analysis included data on 2,073 diabetic and non-diabetic patients from six studies.
Maltese: L-analiżi kienet tinkludi dejta dwar 2,073 pazjent dijabetiku u mhux dijabetiku minn sitt studji.