FrancophonIA/ELRC3.0 huggingface dataset:
English: - threatened abortion during the 1st and 2nd trimester
Maltese: - theddida ta' abort matul l-ewwel u t-tieni trimestru
English: - intrauterine foetal death, known lethal congenital or lethal chromosomal malformation.
Maltese: - mewt tal-fetu fl-utru, malformazzjoni konġenitali letali, jew kromosomali letali magħrufa
English: Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics.
Maltese: Minħabba l-effett anti-ipertensiv addizzjonali, hemm żieda fl-inerzja tal-utru b'riskju ta' emorraġija; barra minn hekk, disturbi serji fir-ritmu ventrikulari minħabba żieda fir-reattività kardijaka, ġew irrappurtati fl-interazzjoni ma' anestetiċi aloġenati.
English: Rare (affects less than 1 in 1,000 people)
Maltese: Rari (jaffetwaw anqas minn persuna 1 minn kull 1,000)
English: Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.
Maltese: Il-pazjenti b'fatturi predisposti li jinkludu tqala multipla, fluwidu żejjed, infezzjoni materna u pre-eklampsja jistgħu jkunu f'riskju akbar li jiżviluppaw edema pulmonari.
English: Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4).
Maltese: Minħabba l-effett ipokalimiku tal-agonisti beta, l-għoti flimkien ma' sustanzi li jnaqqsu l-potassju fiddemm magħrufa li jaggravaw ir-riskju tal-ipokalemija, bħal dijuretiċi, digoxin, xanthines metiliċi u kortikosterojdi, għandu jsir b'kawtela wara vaultazzjoni bir-reqqa tal-benefiċċji u r-riskji b'rigward speċjali għar-riskju akbar ta' arritmiji kardijaċi li jirriżultaw minħabba l-ipokalemija (ara s-sezzjoni 4.4).
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi sussegwentament aġġornata mill-awtoritajiet kompetenti talIstat Membru, f'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Common: *Palpitations, *decrease in diastolic pressure Rare:
Maltese: *Palpitazzjonijiet, *tnaqqis fil-pressjoni dijastolika
English: Halogenated anaesthetics
Maltese: Anestetiċi aloġenati
English: To temporarily delay premature labour
Maltese: Biex tittardja b'mod temporanju ħlas prematur
English: The following monitoring measures must be constantly applied to the mother and, when feasible/appropriate, to the foetus: - blood pressure and heart rate - ECG - electrolyte and fluid balance - to monitor for pulmonary oedema - glucose and lactate levels - with particular regard to diabetic patients - potassium levels- beta-agonists are associated with a decrease in serum potassium which increases the risk of arrhythmias (see section 4.5)
Maltese: Dawn il-miżuri ta' monitoraġġ li ġejjin għandhom jintużaw kontinwament fuq l-omm u, meta jkun possibbli/xieraq, fuq il-fetu: - pressjoni tad-demm u rata tal-qalb - ECG - bilanċ tal-elettroliti u tal-fluwidi - monitoraġġ għall-edema pulmonari - livelli tal-glukożju u tal-lattat - b'attenzjoni partikolari għall-pazjenti dijabetici - livelli tal-potassju - l-agonisti beta huma assoċjati ma' tnaqqis fil-potassju fis-serum li jkompli jżid ir-riskju ta' arritmiji (ara s-sezzjoni 4.5)
English: Rare (affects less than 1 in 1,000 people) Unusual or irregular heartbeats High levels of sugar (glucose) and/or lactic acid in your blood Flushing (reddening) of the face
Maltese: Rari (jaffetwaw anqas minn persuna 1 minn kull 1,000) Taħbit abnormali jew irregolari tal-qalb Livelli għolja ta' zokkor (glukosju) u/jew aċidu lattiku fid-demm tiegħek Fwawar (ħmura) fil-wiċċ
English: • Blood potassium levels (low potassium levels may be associated with a risk of irregular heart beat)
Maltese: • Il-livelli tal-potassju fid-demm (livelli baxxi ta' potassju jistgħu jkunu marbuta ma' riskju ta' taħbita irregolari tal-qalb)
English: Section 3.
Maltese: Sezzjoni 1.
English: If signs of pulmonary oedema or myocardial ischaemia develop, discontinuation of treatment should be considered (see section 4.2 and 4.8).
Maltese: Jekk jiżviluppaw sintomi ta' edema pulmonari jew iskemija mijokardijaka, wieħed għandu jikkunsidra li jwaqqaf il-kura (ara s-sezzjoni 4.2 u 4.8).
English: This includes herbal medicines.
Maltese: Dan jinkludi mediċini erbali.
English: * These reactions have been reported in association with the use of short acting beta-agonists in obstetric indications and are considered class effects (see section 4.4)
Maltese: * Dawn ir-reazzjonijiet kienu rrappurtati b'rabta mal-użu ta' agonisti beta li jaġixxu fuq perjodu qasir f'indikazzjonijiet ostetriċi u huma meqjusa effetti tal-klassi (ara sezzjoni 4.4)
English: The most common undesirable effects of <invented name> are correlated with the betamimetic pharmacological activity and may be limited or avoided by a close monitoring of hemodynamic parameters, such as blood pressure and heart rate, and an appropriate adjustment of the dose.
Maltese: L-aktar effetti mhux mixtieqa komuni ta' <isem inventat> huma korrelatati mal-attività farmakoloġika betamimetika u jistgħu jiġu limitati jew evitati b'monitoraġġ mill-qrib tal-parametri emodinamiċi, bħall-pressjoni tad-demm u r-rata tal-qalb, u aġġustament xieraq tad-doża.
English: Potassium depleting agents
Maltese: Sustanzi li jnaqqsu l-potassju
English: Generally maternal pulse rate should not be allowed to exceed a steady rate of 120 beats per minute.
Maltese: Ġeneralment ir-rata tal-polz tal-omm m'għandhiex titħalla taqbeż ir-rata kostanti ta' 120 taħbita fil-minuta.
English: For the short term management of uncomplicated premature labour To arrest labour between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Maltese: Għall-ġestjoni ta' ħlas qabel iż-żmien mingħajr kumplikazzjonijiet Biex jitwaqqaf il-ħlas bejn it-22 u t-30 ġimgħa tat-tqala f'pazjenti li ma jkollhomx kontraindikazzjoni medika jew ostetrika għal terapija tokolitika.
English: Administration of beta agonists is associated with a rise of blood glucose.
Maltese: L-għoti ta' agonisti beta huwa assoċjat ma' żieda fil-glukożju fid-demm.
English: Duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours; no statistically significant effect on perinatal mortality or morbidity has been observed in randomised, controlled trials.
Maltese: Il-kura m'għandhiex iddum għal aktar minn 48 siegħa billi d-dejta turi li l-effett prinċipali ta' terapija tokolitika huwa l-ittardjar tal-ħlas sa 48 siegħa; ma ġie osservat l-ebda effett statistikament sinifikanti fuq il-mortalità jew il-morbidità perinatali fi provi randomizzati u kkontrollati.
English: Hyperthyroidism
Maltese: Antidijabetiċi
English: - any condition of the mother or foetus in which prolongation of the pregnancy is hazardous, e.g. severe toxaemia, intrauterine infection, vaginal bleeding resulting from placenta praevia, eclampsia or severe preeclampsia, placental abruption, or cord compression.
Maltese: - kwalunkwe kundizzjoni tal-omm jew tal-fetu li fiha t-titwil tat-tqala jkun perikoluż, eż. tossemija severa, infezzjoni fl-utru, fsada mill-vaġina li tirriżulta minn praevia talplaċenta, eklampsja jew preeklampsja severa, distakk tal-plaċenta, jew għafis talkurdun.
English: <invented name> is also contraindicated in any pre-existing medical conditions with which a betamimetic would have an untoward effect e.g., pulmonary hypertension and cardiac disorders such as hypertrophic obstructive cardiomyopathy or any type of obstruction of the left ventricular outflow tract, e.g. aortic stenosis.
Maltese: <isem inventat> huwa kontraindikat ukoll fi kwalunkwe kundizzjoni medika diġà eżistenti li biha betamimetiku jkollu effett ħażin, eż. pressjoni għolja pulmonari u disturbi fil-qalb bħal kardjomijopatija ostruttiva ipertrofika jew kwalunkwe tip ta' ostakolu tal-passaġġ tal-ħruġ ventrikulari tax-xellug, eż. stenożi aortika.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema
Maltese: Huwa importanti kontroll bir-reqqa tal-livell tal-idrazzjoni biex jiġi evitat ir-riskju ta' edima pulmonari fl-omm (ara sezzjoni 4.4).
English: Go to top of the page 4.1 Therapeutic indications
Maltese: Go to top of the page 4.2 Pożoloġija u metodu ta' kif għandu jingħata
English: infusion will limit risk of fluid overload.
Maltese: L-għoti permezz ta' pompa siringa minflok infużjoni fil-vini jnaqqaw ir-riskju ta' fluwidu żejjed.
English: Xanthine medicines (such as theophylline or aminophylline) steroid medicines (such as prednisolone).
Maltese: X'inhu <isem ivvintat> u għalxiex jintuża.
English: - Any condition at a gestational age < 22 weeks
Maltese: - Kwalunkwe kundizzjoni fi tqala ta' < 22 ġimgħa
English: Corticosteroids are known to increase blood glucose and can deplete serum potassium, therefore concomitant administration should be undertaken with caution with continuous patient monitoring owing to the increased risk of hyperglycaemia and hypokalaemia (see section 4.4).
Maltese: Il-kortikosterojdi huma magħrufa li jżidu l-glukożju fid-demm u jistgħu jnaqqsu l-potassju fisserum, għaldaqstant l-għoti flimkien ta' dawn il-mediċini għandu jsir b'kawtela flimkien ma' monitoraġġ kontinwu tal-pazjenta minħabba riskju akbar ta' ipergliċemija u ipokalemija (ara ssezzjoni 4.4).
English: you have an overactive thyroid gland you have a history of heart disease characterised by breathlessness, palpitations or angina (see Do not use <invented name> if).
Maltese: Kwalunkwe referenza għattkomplija tal-kura b'terapija ta' manteniment orali għandha titneħħa.]
English: Cardiac disorders Very common:
Maltese: Kawzjonijiet speċjali għall-infużjoni:
English: The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4).
Maltese: L-għoti ta' agonisti beta huwa assoċjat ma' żieda fil-glukożju fid-demm, li tista' tiġi interpretata bħala attenwazzjoni tal-kura antidijabetika; għaldaqstant il-kura antidijabetika individwali tista' tkun teħtieġ li tiġi aġġustata (ara s-sezzjoni 4.4).
English: Common (affects less than 1 in 10 people) Pounding heart beat (palpitations),
Maltese: Komuni ħafna (jaffetwaw aktar minn persuna 1 minn kull 10)
English: Your doctor will consider the lowering of your dose or discontinuing <invented name> if your heart rate exceeds 120 beats per minute.
Maltese: It-tabib tiegħek se jikkunsidra jnaqqaslek id-doża jew iwaqqaf <isem ivvintat> jekk ir-rata ta' qalbek taqbeż il-120 taħbita kull minuta.
English: If you suffer from heart disease with palpitations (for example heart valve disorder) or longstanding lung disease (for example chronic bronchitis, emphysema) causing an increase of blood pressure to your lungs (pulmonary hypertension)
Maltese: Jekk tbati minn mard tal-qalb b'palpitazzjonijiet (per eżempju disturb tal-valv tal-qalb) jew mard fit-tul tal-pulmun (per eżempju bronkite kronika, enfisema) li jikkawżaw żieda fil-pressjoni taddemm lill-pulmun tiegħek (ipertensjoni pulmonari)
English: If you are scheduled for surgery with general anaesthetics your doctor will stop the administration of <invented name> 6 hours before surgery whenever possible to protect you from adverse effects (e.g. irregular heart beat or bleeding of your womb).
Maltese: Jekk inti skedata għal operazzjoni b'loppju ġenerali t-tabib tiegħek se jwaqqaf l-għoti ta' <isem ivvintat> 6 siegħat qabel l-operazzjoni kull meta jkun possibbli biex tiġi protetta minn effetti avversi (eż. taħbit irregolari tal-qalb jew fsada mill-ġuf tiegħek).
English: Difference in ORR:
Maltese: Differenza f'ORR:
English: Limited data are available in patients > 75 years of age.
Maltese: Hemm disponibbli data limitata f'pazjenti b'età > 75 sena.
English: Number of IDFS events/Total N (%)
Maltese: Numru ta' avvenimenti ta' IDFS/N Totali (%)
English: Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Maltese: Dawn l-istudji inkludew il-provi pivitali CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), u APHINITY (n=4804) [miġbura f'Tabella 2].
English: Neoadjuvant Treatment
Maltese: Trattament Neoadjuvant
English: Progression-Free Survival (independent review) - primary endpoint*
Maltese: Sopravivenza Mingħajr Progressjoni (valutazzjoni indipendenti)punt finali primarju*
English: HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
Maltese: HR= proporzjon ta' periklu; CI= intervall ta' kunfidenza; Pla= plaċebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
English: The active substance is pertuzumab.
Maltese: • Is-sustanza attiva hi pertuzumab.
English: Tél: +33 (0)1 47 61 40 00
Maltese: Roche Tél: +33 (0)1 47 61 40 00
English: Glacial acetic acid, L-histidine, sucrose and polysorbate 20.
Maltese: Acetic acid, glacial, L-Histidine, Sucrose u Polysorbate 20.
English: Glacial acetic acid L-Histidine Sucrose
Maltese: Acetic acid, glacial L-Histidine
English: 4. p-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
Maltese: Valur p mit-test Cochran-Mantel-Haenszel, b'aġġustament għall-multipliċità Simes.
English: The BERENICE study included two parallel groups of patients.
Maltese: L-istudju BERENICE inkluda żewġ gruppi paralleli ta' pazjenti.
English: Approximate 95% CI for difference of two response rates using Hauck-Anderson method.
Maltese: 3. CI ta' 95% approssimattiv għad-differenza taż-żewġ rati ta' rispons bl-użu tal-metodu Hauck-Anderson.
English: 3-year event-free rate derived from Kaplan-Meier estimates.
Maltese: Rata ta' 3 snin mingħajr avveniment derivata mill-estimi Kaplan-Meier.
English: Data from first interim analysis.
Maltese: Data mill-ewwel analiżi interim.
English: Patient Reported Outcomes (PRO)
Maltese: Riżultati Rrappurtati mill-Pazjent (PRO - Patient Reported Outcomes)
English: Table 4 NEOSPHERE (WO20697) and TRYPHAENA (BO22280): Overview of efficacy (Intent to Treat Population)
Maltese: Tabella 4 NEOSPHERE (WO20697) u TRYPHAENA (BO22280):
English: Standard doses of 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamide, docetaxel, paclitaxel and carboplatin were administered.
Maltese: Ingħataw dożi standard ta' 5-fluorouracil, epirubicin, doxorubicin, cyclophosphamide, docetaxel, paclitaxel u carboplatin.
English: The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency:
Maltese: L-ADRs huma elenkati taħt skont is-sistema tal-klassifika tal-organi MedDRA (SOC) u l-kategoriji ta' frekwenza:
English: Adjuvant Treatment
Maltese: Trattament Adjuvant
English: Cardiac failure congestive**
Maltese: Disfunzjoni talventriklu taxxellug**
English: Perjeta is compatible with polyvinylchloride (PVC) or non-PVC polyolefin bags including polyethylene.
Maltese: Ma kienux osservati inkompatibbiltajiet bejn Perjeta u boroż magħmula minn polyvinylchloride (PVC) jew boroż tal-polyolefin mingħajr PVC inkluż polyethylene.
English: Across all clinical studies, the volume of distribution of the central (Vc) and the peripheral (Vp) compartment in the typical patient, was 3.11 litres and 2.46 litres, respectively.
Maltese: Matul l-istudji kliniċi kollha, il-volum ta' distribuzzjoni tal-kompartiment ċentrali (Vc) u periferali (Vp) f'pazjent tipiku, kien ta' 3.11-il litru u 2.46 litru, rispettivament.
English: Number (%) of patients with event HR [95% CI]
Maltese: Numru (%) ta' pazjenti b'avveniment HR [CI ta' 95%]
English: FEC (5-fluorouracil [500 mg/m2], epirubicin [100 mg/m2], cyclophosphamide [600 mg/m2]) were given intravenously every three weeks for 3 cycles.
Maltese: FEC (52], epirubicin [100 mg/m 2], cyclophosphamide [600 mg/m 2]) ingħataw fil-vini fluorouracil [500 mg/m kull tliet ġimgħat għal 3 ċikli.
English: Patients with metastases, bilateral breast cancer, clinically important cardiac risk factors (see section 4.4) or LVEF < 55% were not included.
Maltese: Pazjenti b'metastasi, kanċer tas-sider bilaterali, fatturi ta' riskju kardijaċi klinikament importanti (ara sezzjoni 4.4) jew LVEF < 55% ma kienux inklużi.
English: Name and address of the manufacturer of the biological active substance(s) Genentech, Inc.
Maltese: Isem u indirizz tal-manifattur tas-sustanza(i) bijoloġika(ċi) attiva(i) Genentech, Inc.
English: You will be given 420 mg of Perjeta over 30 to 60 minutes.
Maltese: • Se tingħata 420 mg ta' Perjeta fuq perijodu ta' 30 sa 60 minuta.
English: 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)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: 95% CI for one sample binomial using Pearson-Clopper method.
Maltese: 1. CI ta' 95% għal kampjun binomju wieħed bl-użu tal-metodu Pearson-Clopper.
English: Immune system disorders Infusion reaction°°, * Hypersensitivity°, *
Maltese: Sensittività eċċessiva°, * Sensittività eċċessiva għallmediċina°, *
English: No adverse reactions were observed in sexually mature female cynomolgus monkeys exposed to pertuzumab (see section 5.3).
Maltese: Ma kinux osservati effetti avversi f'xadini cynomolgus femminili sesswalment maturi esposti għal pertuzumab (ara sezzjoni 5.3).
English: Figure 1 IRF-assessed PFS by patient subgroup
Maltese: Figura 1 PFS evalwata minn IRF skont is-sotto grupp tal-pazjent
English: Decreases in LVEF have been reported with medicinal products that block HER2 activity, including Perjeta.
Maltese: Tnaqqis fl-LVEF ġie rrappurtat bi prodotti mediċinali li jimblukkaw l-attività ta' HER2, inkluż Perjeta.
English: In the TRYPHAENA study, Perjeta was given concurrently with epirubicin, as part of the FEC (5-fluorouracil, epirubicin, cyclophosphamide) regimen (see sections 4.8 and 5.1).
Maltese: Fl-istudju TRYPHAENA, Perjeta ngħata flimkien ma' epirubicin, bħala parti mill-kors FEC (5-fluorouracil, epirubicin, cyclophosphamide) (ara sezzjonijiet 4.8 u 5.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/813/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/813/001
English: For instructions on dilution of Perjeta prior to administration, see sections 6.2 and 6.6.
Maltese: Għal istruzzjonijiet fuq dilwizzjoni ta' Perjeta qabel jingħata, ara sezzjonijiet 6.2 u 6.6.
English: Mus culoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: 3.3% (13/389 patients) of Perjeta-treated patients and 6.7% (25/372 patients) of placebo-treated patients tested positive for ADA.
Maltese: 3.3% (13/389 pazjent) tal-pazjenti kkurati b'Perjeta u 6.7% (25/372 pazjent) tal-pazjenti kkurati bil-plaċebo ittestjaw pożittivi għall-ADA.
English: Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4.
Maltese: Pertuzumab huwa antikorp monoklonali rikombinanti umanizzat li jimmira speċifikament d-dominju ta' dimerizzazzjoni ekstraċellulari (sottodominju II) tal-proteina tar-riċettur 2 tal-fattur ta' tkabbir epidermali uman (HER2), u b'hekk, jimblokka l-etero dimerizzazzjoni dipendenti mil-ligand ta' HER2 ma' membri oħra tal-familja HER, inkluż EGFR, HER3 u HER4.
English: Placebo+ trastuzumab + docetaxel n=406
Maltese: Plaċebo trastuzumab + docetaxel n = 406
English: The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group).
Maltese: L-analiżi finali ta' OS twettqet meta 389 pazjent kienu mietu (221 fil-grupp ikkurat bil-plaċebo u 168 fil-grupp ikkurat b'Perjeta).
English: Insomnia
Maltese: Insomnija
English: A statistically significant improvement in pCR rate (ypT0/is) was observed in patients receiving Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel (45.8% vs 29.0%, p value = 0.0141).
Maltese: Kien osservat titjib statistikament sinifikanti firrata ta' pCR (ypT0/is) f'pazjenti li rċevew Perjeta flimkien ma' trastuzumab u docetaxel meta mqabbel ma' pazjenti li rċevew trastuzumab u docetaxel (45.8% kontra 29.0%, valur p = 0.0141).
English: Date of first authorisation: 4th March 2013 Date of latest renewal: 8th December 2017
Maltese: Data tal-aħħar tiġdid: 8 ta' Diċembru 2017
English: Patients were randomised 1:1 to receive placebo + trastuzumab + docetaxel or Perjeta + trastuzumab + docetaxel.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu plaċebo + trastuzumab + docetaxel jew Perjeta + trastuzumab + docetaxel.
English: In addition, consistent with foetal growth restrictions, secondary to oligohydramnios, lung hypoplasia (1 of 6 in 30 mg/kg and 1 of 2 in100 mg/kg groups), ventricular septal defects (1 of 6 in 30 mg/kg group), thin ventricular wall (1 of 2 in 100 mg/kg group) and minor skeletal defects (external - 3 of 6 in 30 mg/kg group) were also noted.
Maltese: Barra dan, konsistenti ma' restrizzjonijiet tat-tkabbir tal-fetu, sekondarji għal tnaqqis fil-fluwidu tal-borqom, kienu innutati wkoll ipoplażija tal-pulmun (1 minn 6 fil-grupp ta' 30 mg/kg u 1 minn 2 fil-grupp ta' 100 mg/kg), difetti fisseptum tal-ventriklu (1 minn 6 fil-grupp ta' 30 mg/kg), ħajt ventrikulari irqiq (1 minn 2 fil-grupp ta' 100 mg/kg) u difetti skeletali minuri (estern - 3 minn 6 fil-grupp ta' 30 mg/kg).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Maltese: Stabbiltà kimika u fiżika waqt l-użu kienet demostrata għal 24 siegħa f'temperatura ta' 30°C.
English: Figure 2 Kaplan-Meier Curve of Overall Survival
Maltese: Kaplan-Meier għas-Sopravivenza Globali
English: No dose recommendations can be made for patients with severe renal impairment because of the limited pharmacokinetic data available (see section 5.2).
Maltese: Ma jistgħux isiru rakkomandazzjonijiet tad-doża għall-pazjenti b'indeboliment renali sever peress li hemm disponibbli data farmakokinetika limitata (ara sezzjoni 5.2).
English: Table 2 summarizes the ADRs from the Perjeta-treated groups of the following pivotal clinical trials:
Maltese: Tabella 2 tiġbor fil-qosor l-ADRs mill-gruppi ttrattati b'Perjeta tal-provi kliniċi pivitali li ġejjin:
English: • NEOSPHERE (n=309) and TRYPHAENA (n=218), in which neoadjuvant Perjeta was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory, or early breast cancer
Maltese: • NEOSPHERE (n=309) u TRYPHAENA (n=218), fejn Perjeta neoadjuvant ingħata flimkien ma' trastuzumab u kimoterapija lill-pazjenti b'kanċer avanzat lokalment, infjammatorju, jew kanċer bikri tas-sider.
English: Perjeta+ Trastuzuma b N=107
Maltese: Trastuzuma b N=107
English: Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of pertuzumab between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni, ma kienet osservata l-ebda differenza sinifikanti fil-farmakokinetika ta' pertuzumab bejn pazjenti < 65 sena (n=306) u pazjenti ≥ 65 sena (n=175).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC13
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali Kodiċi ATC: