FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders Very common Rash (including dermatitis acneiform) (see section 4.2 - dose delay and dose reduction - other toxicities), dry skin* †, palmar-plantar erythrodysaesthesia*, alopecia †, pruritus
Maltese: Raxx (inkluż dermatite akneform) (ara sezzjoni 4.2 - posponiment taddoża u tnaqqis fid-doża - tossiċitajiet oħra), ġilda xotta*
English: Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged**
Maltese: Arritmiji ventrikulari/Torsades de Pointes, elettrokardjogramm bi QT imtawwal
English: Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity.
Maltese: Il-pazjenti li jġorru l-alleles DQA1*02:01u DRB1*07:01 ta' HLA għandhom riskju akbar ta' tossiċità tal-fwied marbuta ma' Tyverb.
English: Tyverb is for oral use.
Maltese: Tyverb huwa għal użu orali.
English: Very common Hot flush Respiratory, thoracic and mediastinal disorders Very common Epistaxis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna
English: Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Maltese: Meta lapatinib ingħata flimkien ma' capecitabine, eritrodisasteżija palmari-plantari (PPE) kienet komuni ukoll (> 25 %).
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti medicinali oħra u forom oħra ta' interazzjoni
English: There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/kg/day (females) and up to 180 mg/kg/day (males) (8 and 3 times the expected human clinical exposure, respectively).
Maltese: Ma kienx hemm effetti fuq il-funzjoni gonadali tal-far raġel jew mara, tgħammir jew fertilità f'dożi sa 120 mg/kg/kuljum (nisa) u sa 180 mg/kg/kuljum (irġiel) (8 u 3 darbiet aktar mill-esponiment kliniku uman mistenni, rispettivament).
English: Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3-fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively, as compared with administration in the fasted state.
Maltese: Valuri ta' l-AUC ta' laptinib kienu bejn wieħed u ieħor 3 u 4 darbiet ogħla (Cmax bejn wieħed u ieħor 2.5 sa 3 darbiet ogħla) meta ġie amministrat ma' ikel b'kontenut baxx ta' xaħam (5 % xaħam [500 kalorija]) jew ma' ikla b'kontenut ogħli ta' xaħam (50 % xaħam [1,000 kalorija]), rispettivament, meta mqabbel mal-għoti fi stat ta'sawm.
English: • unusual hair loss or thinning
Maltese: • tisfir mhux tas-soltu u diffikulta' fin-nifs
English: Lapatinib inhibits the transport protein Pgp in vitro at clinically relevant concentrations.
Maltese: Lapatinib jimpedixxi l-proteina ta' trasport Pgp in vitro f'konċentrazzjonijiet rilevanti b'mod kliniku.
English: Interstitial lung disease/pneumonitis.
Maltese: Mard ta' l-interstizju tal-pulmun/pulmonite.
English: • tiredness, feeling weak
Maltese: • sogħla, qtugħ ta' nifs
English: Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
Maltese: Tyverb huwa indikat għall-kura ta' pazjenti adulti b'kanċer tas-sider, li t-tumuri tagħhom jesprimu HER2 (ErbB2) żejjed;
English: Tyverb may be reintroduced at a lower dose (reduced from 1000 mg/day to 750 mg/day, from 1250 mg/day to 1000 mg/day or from 1500 mg/day to 1250 mg/day) when diarrhoea resolves to grade 1 or less.
Maltese: Tyverb jista' jerġa' jinbeda mill-ġdid b'doża aktar baxxa (imnaqqsa minn 1000 mg/kuljum għal 750 mg/kuljum, minn 1250 mg/kuljum għal 1000 mg/kuljum jew minn 1500 mg/kuljum għal 1250 mg/kuljum) meta ddijarea titjieb għal grad 1 jew anqas.
English: Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Maltese: Lapatinib jgħaddi minn metaboliżmu estensiv, primarjament permezz ta' CYP3A4 u CYP3A5, b'kontribuzzjonijiet żgħar minn CYP2C19 u CYP2C8 li jwassal għal taħlita ta' sustanzi talmetaboliżmu ossidati, li l-ebda waħda minnhom ma' tikkontribwixxi għal aktar minn 14 % tad-doża li nkisbet lura mill-ippurgar jew 10 % tal-konċentrazzjoni ta' lapatinib fil-plażma.
English: If erythema multiforme or life-threatening reactions such as Stevens-Johnson syndrome, or toxic epidermal necrolysis (e.g. progressive skin rash often with blisters or mucosal lesions) are suspected, discontinue treatment with Tyverb.
Maltese: Jekk eritema multiforme jew reazzjonijiet li jkunu theddida għall-ħajja bħas-sindromu ta' Stevens-Johnson, jew nekroliżi epidermali tossika (eż raxx progressiv tal-ġilda spiss bl-infafet jew leżjonijiet tal-mukuż) ikunu suspettati, waqqaf ittrattament b'Tyverb.
English: Tyverb / capecitabine combination posology
Maltese: Pożoloġija tat-taħlita Tyverb / capecitabine
English: b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine.
Maltese: b. Stima Pike tal-proporzjon ta' periklu tal-kura, < 1 juri riskju inqas għal Tyverb mogħti flimkien ma' capecitabine meta mqabbel ma'' Trastuzumab mogħti flimkien ma' capecitabine. 1.Avveniment PFS huwa persuna Progressat jew Mietet u Avveniment OS huwa persuna li Mietet minħabba kwalunkwe kawża.
English: Caution should be taken if Tyverb is administered to patients with conditions that could result in prolongation of QTc (including hypokalemia, hypomagnesemia, and congenital long QT syndrome), co-administration of other medicinal product known to cause QT prolongation, or conditions that increase the exposure of lapatinib, such as co-administration of strong CYP3A4 inhibitors.
Maltese: Għandha tittieħed kawtela jekk Tyverb jingħata lill-pazjenti b'kundizzjonijiet li jistgħu jwasslu għal titwil ta' QTc (inklużi ipokalimja, ipomagnesimja, u sindrome konġenitali ta' QT twil), l-għoti flimkien ta' prodotti mediċinali oħra magħrufa li jikkawżaw titwil ta' QT, jew kundizzjonijiet li jżidu l-espożizzjoni ta' lapatinib, fosthom l-għoti flimkien ta' inibituri qawwija ta' CYP3A4.
English: Most patients in both treatment arms had visceral disease (215 [73%] patients overall).
Maltese: Il-maġġoranza talpazjenti fiż-żewġ gruppi ta' kura kellhom mard vixxerali (215 [73 %] pazjent b'mod globali).
English: Final OS analysis (post-hoc analysis, 07 August 2013) Median follow-up (yrs) Deaths (%) Hazard ratio (95% CI), p-value Median values from Kaplan-Meier analysis; HR and p-values from Cox regression models adjusting for important prognostic factors.
Maltese: Valuri medji mill-analiżi Kaplan-Meier; HR u l-valuri-p minn mudelli rigressjoni Cox aġġustament għal fatturi pronostiċi importanti.
English: Lapatinib is not significantly renally excreted and is highly bound to plasma proteins, therefore haemodialysis would not be expected to be an effective method to enhance the elimination of lapatinib.
Maltese: Lapatinib ma jitneħħiex b'mod sinifikanti mill-kliewi u jeħel ħafna mal-proteini fil-plażma, għalhekk id-dijalisi tad-demm ma tkunx mistennija li tkun metodu effettiv biex ittejjeb l-eliminazzjoni ta' lapatinib.
English: Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4).
Maltese: Tnaqqis fil-porzjon imbuttat 'l barra mill-ventriklu tan-naħa tax-xellug (ara sezzjoni 4.2 - tnaqqis fid-doża - avvenimenti fil-qalb u sezzjoni 4.4)
English: The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Maltese: Id-doża rakkomandata ta' Tyverb hija 1000 mg (jiġifieri erba' pilloli) darba kuljum kontinwament.
English: • rash, dry skin, itching
Maltese: • raxx, ġilda xotta, ħakk
English: LVEF was evaluated in all patients (using echocardiogram [Echo] or multi gated acquisition scan [MUGA]) prior to initiation of treatment with Tyverb to ensure baseline LVEF was within the institutions normal limits.
Maltese: L-LVEF kien ivvalutat fil-pazjenti kollha (permezz ta' ekukardjugramm [Echo - echocardiogram] jew multi gated acquisition scan [MUGA]) qabel ma' nbdiet il-kura b'Tyverb biex jiġi żgurat li l-linja bażi ta' LVEF kienet fil-limiti tan-normal ta' l-istituzzjoni.
English: Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, use of antibiotics such as fluoroquinolones (especially if diarrhoea is persistent beyond 24 hours, there is fever, or grade 3 or 4 neutropenia) and interruption or discontinuation of Tyverb therapy (see section 4.2 - dose delay and dose reduction -diarrhoea).
Maltese: Każi serji ta' dijarea jista' jkollhom bżonn amministrazzjoni ta' fluwidi u elettroliti orali jew ġol-vini, l-użu ta' antibijotiċi bħal fluoroquinolones (speċjalment jekk id-dijarea tkun persistenti għal aktar minn 24 siegħa, ikun hemm id-deni, jew newtropenija ta' grad 3 jew 4) u interruzzjoni jew sospensjoni ta' terapija b'Tyverb (ara sezzjoni 4.2posponiment tad-doża jew tnaqqis fid-doża - dijarea).
English: Observed adverse reactions included dyspnoea, cardiac failure and palpitations.
Maltese: Reazzjonijiet avversi osservati kienu jinkludu dispneja, insuffiċjenza kardijaka u palpitazzjonijiet.
English: LVEF decreases resolved or improved in more than 70 % of cases, in approximately 60 % of these on discontinuation of treatment with lapatinib, and in approximately 40 % of cases lapatinib was continued.
Maltese: Tnaqqis fl-LVEF irrisolva kompletament jew mar għall-aħjar f'aktar minn 70 % tal-każijiet, b'madwar 60 % ta' dawn meta twaqqfet il-kura b'lapatinib, u f'madwar 40 % tal-każijiet lapatinib tkompla.
English: Tyverb 250 mg film-coated tablets lapatinib
Maltese: Tyverb 250 mg pilloli miksijin b'rita lapatinib
English: There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily.
Maltese: Kien hemm ukoll żieda ta' infarti renali u nekrożi papillari f'firien nisa f'espożizzjonijiet 7 u 10 darbiet aktar meta mqabbla ma' bnedmin li ngħataw 1250 mg ta' lapatinib darba kuljum.
English: Tyverb / trastuzumab combination posology
Maltese: Kura kombinata b'Tyverb u trastuzumab
English: How to take Tyverb
Maltese: X'fih Tyverb
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 and /or CYP2C8 should be avoided (see section 4.5).
Maltese: L-amministrazzjoni ta' Tyverb flimkien ma' prodotti mediċinali li jingħataw mill-ħalq, li għandhom indiċi terapewtiċi dojoq u li huma sustrati ta' CYP3A4 u /jew CYP2C8 għandhom jiġu evitati (ara sezzjoni 4.5).
English: Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.
Maltese: Tyverb jinstab ukoll f'pakketti multipli li fihom 140 pillola magħmulin minn żewġ pakketti, li kull wieħed minnhom fih 70 pillola.
English: • if you have any liver problems
Maltese: • jekk għandek xi problemi fil-kliewi
English: Combination treatment with Tyverb and trastuzumab
Maltese: Pożoloġija tat-taħlita Tyverb / trastuzumab
English: Combination treatment with Tyverb and capecitabine
Maltese: Kura kombinata b'Tyverb u capecitabine
English: Serious skin reactions have been seen with Tyverb.
Maltese: Reazzjonijiet serji tal-ġilda ġew osservati b' Tyverb.
English: Median OS
Maltese: Mhux komuni
English: Lapatinib has been associated with reports of decreases in LVEF (see section 4.8).
Maltese: Lapatinib ġie assoċjat ma' rapporti ta' tnaqqis f'LVEF (ara sezzjoni 4.8).
English: • stomach pain
Maltese: • problema biex torqod
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu (95 % CI)
English: Tyverb may be restarted at a reduced dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Maltese: Tyverb jista' jerġa' jinbeda b'doża imnaqqsa (750 mg/ġurnata meta jingħata ma' trastuzumab,1000 mg/ġurnata meta mogħti ma' capecitabine jew 1250 mg/kuljum meta mogħti ma' inibitur ta' aromatase) wara minimu ta' ġimgħatejn u jekk l-LVEF jirkupra għan-normal u l-pazjent ma' jkollux sintomi.
English: Investigator assessment Tyverb (1250 mg/day)+ capecitabine (2000 mg/m2/day,
Maltese: Stima ta' l-investigatur Tyverb (1250 mg/ġurnata) + capecitabine (2000mg/m2/ġurnata, ġranet 1-14 kull 21 ġurnata)
English: Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.
Maltese: Pilloli ovali, konvessi fuq iż-żewġ naħat, sofor miksijin b'rita, b' “GS XJG” imħaffra fuq naħa waħda.
English: Lapatinib has not been evaluated in patients with symptomatic cardiac failure.
Maltese: Lapatinib ma kienx evalwat f'pazjenti b'insuffiċjenza sintomatika tal-qalb.
English: Biotransformation
Maltese: Sopravivenza globali
English: Number of TTP events 121 Median TTP, weeks Hazard Ratio (95% CI) p value
Maltese: PFS medjan, ġimgħat (95 % CI)
English: This was followed by three doses of lapatinib 2000 mg administered in the same way.
Maltese: Dan kien segwit minn tliet dożi ta' lapatinib 2000 mg mogħtija bl-istess mod.
English: Trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions)
Maltese: Trastuzumab (doża akbar ta' 8 mg/kg filbidu segwita minn 6mg/kg darba kull 3 ġimgħat) + capecitabine (2500 mg/m2/ġurnata , ġranet 1-14 kull 21 ġurnata)
English: Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
Maltese: L-għoti flimkien ta' lapatinib ma' paclitaxel minn ġol-vini żied l-esponiment għal paclitaxel bi 23 %, minħabba l-impediment ta' CYP2C8 u/jew Pgp permezz ta' lapatinib.
English: If you suffer from diarrhoea while taking Tyverb:
Maltese: Jekk tbati minn dijarea waqt li qed tieħu Tyverb:
English: Patients who had objective disease progression after receiving at least 4 weeks of treatment with lapatinib monotherapy were eligible to crossover to combination therapy.
Maltese: Ilpazjenti li kellhom progressjoni oġġettiva tal-marda wara li rċevew mill-anqas 4 ġimgħat ta' kura b'lapatinib waħdu kienu eliġibbli sabiex jaqilbu għal terapija kombinata.
English: Concomitant administration of Tyverb with capecitabine, letrozole or trastuzumab did not meaningfully alter the pharmacokinetics of these medicinal products (or the metabolites of capecitabine) or lapatinib.
Maltese: L-amministrazzjoni konkomitanti ta' Tyverb ma' capecitabine, letrozole u trastuzumab ma bidlitx b'mod sinifikattiv il-farmakokinetika ta' dawn il-prodotti mediċinali (jew il-metaboliti ta' capecitabine) jew ta' lapatinib.
English: Clinical benefit rate was defined as complete plus partial response plus stable disease for 6 months.
Maltese: Ir-Rata ta' benefiċċju kliniku kienet definita bħala rispons komplet flimkien ma' rispons parzjali u marda stabbli għal  6 xhur.
English: Serious cutaneous reactions have been reported with Tyverb.
Maltese: Reazzjonijiet serji tal-ġilda ġew rapportati b'Tyverb.
English: An additional increase in peak exposure of lapatinib can be expected when lapatinib is taken repeatedly with food (see sections 4.2 and 5.2) or concomitantly with strong CYP3A4 inhibitors.
Maltese: Hi mistennija żieda oħra fil-quċċata tal-espożizzjoni ta' lapatinib meta lapatinib jittieħed ripetutament mal-ikel (ara sezzjonijiet 4.2 u 5.2) jew flimkien ma' inibituri qawwija ta' CYP3A4.
English: In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
Maltese: Fil-popolazzjoni negattiva għall-HER2, ma kien hemm l-ebda benefiċċju fil-PFS meta letrozole flimkien ma' Tyverb kien imqabbel ma' letrozole flimkien malplaċebo (ara Tabella 6).
English: There was an increased incidence of cardiac toxicity, but these events were comparable in nature and severity to those reported from the lapatinib clinical programme (see section 4.4cardiac toxicity).
Maltese: Kien hemm żieda fl-inċidenza ta' tossiċità tal-qalb, iżda dawn l-avvenimenti kienu komparabbli fin-natura u s-severità tagħhom ma' dawk irrappurtati mill-programm kliniku b'lapatinib (ara sezzjoni 4.4 - tossiċità tal-qalb).
English: Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each.
Maltese: Kull pakkett Tyverb fih 70 jew 84 pillola f'folji ta' l-aluminju ta' 10 jew 12-il pilloli l-waħda.
English: Co-administration of Tyverb with orally administered midazolam resulted in an approximate 45% increase in the AUC of midazolam.
Maltese: L-amministrazzjoni ta' Tyverb flimkien ma' midazolam mill-ħalq irriżulta f'żieda ta' bejn wieħed u ieħor 45 % fl-AUC ta' midazolam.
English: Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment.
Maltese: Mill-148 li rċevew kura b'mediċina waħda, 77 (52 %) pazjent fil-mument tal-progressjoni tal-marda għażlu li jirċievu kura kombinata.
English: Film-coated tablet
Maltese: Avvenimenti fil-qalb
English: Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported.
Maltese: Dijarea tista' tkun b'potenzjal ta' periklu għall-ħajja jekk tkun akkumpanjata minn deidratazzjoni, insuffiċjenza talkliewi, newtropenija u/jew żbilanċ fl-elettroliti u kienu rrappurtati każijiet fatali.
English: NE=median was not reached.
Maltese: NE=medjan ma nlaħaqx.
English: Caution should be exercised when dosing lapatinib concurrently with medicinal products with narrow therapeutic windows that are substrates of Pgp, and a reduction in the dose of the Pgp substrate should be considered.
Maltese: Għandu jkun hemm kawtela meta dożi ta' lapatinib jingħataw flimkien ma' prodotti mediċinali b'indiċi terapewtiċi stretti li huma substrati ta' Pgp, u għandu jiġi kkunsidrat tnaqqis middoża tas-substrat ta' Pgp.
English: Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated tablets.
Maltese: Tyverb jiġi wkoll fi fliexken tal-polyethylene ta' densità għolja (HDPE) b'għatu tal-polypropylene li ma jinfetaħx mit-tfal li jkun fihom 70, 84, 105 jew 140 pillola miksija b'rita.
English: The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously.
Maltese: Id-doża rakkommandata ta' Tyverb hija 1250 mg (jiġifieri ħames pilloli) darba kuljum kontinwament.
English: In the Tyverb plus capecitabine arm 8 patients (3.2%) experienced CNS as site of first progression, compared with 12 patients (4.8%) in the trastuzumab plus capecitabine arm.
Maltese: Fil-fergħa ta' Tyverb mogħti flimkien ma' capecitabine 8 pazjenti (3.2 %) kellhom is-CNS bħala s-sit tal-ewwel progressjoni, meta mqabbla ma' 12-il pazjent (4.8 %) fil-fergħa ta' trastuzumab mogħti flimkien ma' capecitabine.
English: Interstitial lung disease and pneumonitis
Maltese: Meta tieħu l-pilloli
English: There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
Maltese: Kien hemm 952 pazjenti b'tumuri negattivi għal HER2, u total ta' 115-il pazjent li l-istat HER2 tat-tumur tagħhom ma kienx ikkonfermat (l-ebda kampjun tat-tumur, l-ebda riżultat ta' l-analiżi, jew raġuni oħra).
English: Lapatinib effect on CNS metastasis
Maltese: Effett ta' Lapatinib fuq metastażi tas-CNS (Sistema Nervuża Ċentrali)
English: LVEF decreases were reported in 3.1 % of patients who received lapatinib in combination with letrozole as compared to 1.3 % of patients receiving letrozole plus placebo.
Maltese: Tnaqqis f'LVEF kien irrappurtat f'3.1 % tal-pazjenti li rċevew lapatinib flimkien ma' letrozole meta mqabbel ma' 1.3 % tal-pazjenti li rċevew letrozole ma' plaċebo.
English: In the rat preand postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/kg/day or higher (5 times the expected human clinical exposure).
Maltese: Fl-istudju ta' l-iżvilupp tal-far qabel u wara ttwelid, kien hemm tnaqqis fis-sopravivenza tal-frieħ bejn it-twelid u l-21 ġurnata wara t-twelid f'dożi ta' 60mg/kg/kuljum jew aktar (5 darbiet aktar mill-esponiment kliniku uman mistenni).
English: Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 70% of cases.
Maltese: Tnaqqis fil-porzjon imbuttat 'il barra mill-ventrikulu tan-naħa tax-xellug (LVEF) kien irrappurtat f'bejn wieħed u ieħor 1 % tal-pazjenti li kienu qed jirċievu lapatinib u li ma kienux juru sintomi f'aktar minn 70 % tal-każi.
English: 70 film-coated tablets 84 film-coated tablets
Maltese: Pillola miksija b'rita 70 pillola miksija b'rita 84 pillola miksija b'rita
English: Combination treatment with Tyverb and letrozole
Maltese: Kura kombinata b'Tyverb u letrozole
English: Median PFS, weeks (95% CI) Hazard ratio 0.71 (0.53, 0.96) P-value Objective response rate (ORR) Odds ratio 0.4 (0.2, 0.9) P-value Clinical benefit rate (CBR) Odds ratio 0.4 (0.2, 0.8) P-value
Maltese: (95 % CI) Proporzjon tal-periklu (95% CI) 0.74 (0.57, 0.97) Valur P PFS = sopravivenza mingħajr progressjoni tal-marda; CI = intervall ta' kunfidenza.
English: There is more advice on reducing the risk of skin rash at the end of section 4.
Maltese: Hemm aktar pariri dwar dwar kif tnaqqas ir-riskju ta' raxx fil-ġilda fl-aħħar ta' sezzjoni 4.
English: Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
Maltese: Il-pazjenti kienu randomised għal letrozole 2.5 mg darba kuljum flimkien ma' Tyverb 1500 mg darba kuljum jew letrozole flimkien mal-plaċebo.
English: At ≥60 mg/kg/day there were decreased foetal body weights, and minor skeletal variations.
Maltese: F'doża ta' ≥ 60 mg/kg/kuljum kien hemm tnaqqis fil-piż tal-fetu u varjazzjonijiet skelettrali żgħar.
English: In patients with HER2-overexpressing MBC, investigator-determined progression-free survival (PFS) was significantly greater with letrozole plus Tyverb compared with letrozole plus placebo.
Maltese: F'pazjenti b'MBC li jesprimi HER2 żejjed, is-sopravivenza mingħajr progressjoni (PFS) iddetermiata mill-investigatur kienet akbar b'mod sinifikanti b'letrozole flimkien ma' Tyverb meta mqabbel ma' letrozole flimkien mal-plaċebo.
English: In oral carcinogenicity studies with lapatinib, severe skin lesions were seen at the highest doses tested which produced exposures based on AUC up to 2-fold in mice and male rats, and up to 15-fold in female rats, compared to humans given 1250 mg of lapatinib once daily.
Maltese: Fi studji dwar karċinoġeniċita' orali b'lapatinib, dehru leżjonijiet severi tal-ġilda bl-aktar dożi għoljin ittestjati li pproduċew espożizzjozzjonijiet ibbażati fuq AUC sa 2-darbiet fi ġrieden u firien irġiel, u sa 15-il darba f'firien nisa, meta mqabbla mal-bniedem li ingħata 1250 mg ta' lapatinib darba kuljum.
English: Progression-free survival (PFS) was the primary endpoint of the study with response rate and overall survival (OS) as secondary endpoints.
Maltese: Is-sopravivenza mingħajr progressjoni tal-marda (PFS) kienet l-endpoint primarju tal-istudju, bir-rata ta' rispons u s-sopravivenza globali (OS) bħala l-endpoints sekondarji.
English: • being sick (vomiting)
Maltese: • tirremetti (tivvomta)
English: • Keep this leaflet.
Maltese: Proporzjon ta' periklu
English: Capecitabine (2500 mg/m 2/day,
Maltese: Tyverb (1250 mg/day)
English: • cough, shortness of breath
Maltese: • għeja, tħossok debboli
English: Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Cardiac toxicity
Maltese: Tossiċitajiet oħra