FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the chemotherapy treatment, there are two ways IVEMEND may be given: IVEMEND is given only on Day 1 (single day of chemotherapy) IVEMEND is given on Day 1, 2, and 3 (single or multiple days of chemotherapy) o Oral formulations of aprepitant may be prescribed on Days 2 and 3 instead of IVEMEND.
Maltese: IVEMEND jingħata biss f'Jum 1 (jum wieħed ta' kimoterapija) IVEMEND jingħata fil-Jiem 1, 2, u 3 (jum wieħed jew ħafna jiem ta' kimoterapija) o Formulazzjonijiet ta' aprepitant mill-ħalq jistgħu jiġu ordnati fil-Jiem 2 u 3 minflok IVEMEND.
English: Plasma concentrations of fosaprepitant are below quantifiable levels within 30 minutes of the completion of infusion.
Maltese: Konċentrazzjonijiet fil-plażma ta' fosaprepitant kienu taħt livelli li jistgħu jkunu ikkwantifikati fi żmien 30 minuta mit-tlestija tal-infużjoni.
English: 10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.
Maltese: Kunjett tal-ħġieġ ċar Tip I ta' 10 ml, tapp tal-lastiku tal-chlorobutyl jew bromobutyl u siġill talaluminju b'kappa tal-plastik griża li titneħħa b'saba' wieħed.
English: Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy.
Maltese: Tnax-il metabolit ta' aprepitant ġew identifikati filplażma tal-bniedem.
English: In a juvenile toxicity study in rats treated with aprepitant from postnatal day 10 to day 63, earlier vaginal opening in females from 250 mg/kg b.i.d.
Maltese: Fi studju dwar l-effetti tossiċi fil-frieħ fil-firien ittrattatib'aprepitant minn jum 10 sa jum 63 wara t-twelid, deher ftuħ bikri tal-vaġina fin-nisa minn 250 mg/kg b.i.d. u separazzjoni mdewma tal-prepuzju fl-irġiel minn 10 mg/kg b.i.d.
English: Some less common ADRs in the adult population were not observed in the paediatric studies.
Maltese: Xi ADRs inqas komuni fil-popolazzjoni adulta ma kinux osservati fl-istudji pedjatriċi.
English: The adverse reactions profiles in the Multiple-Cycle extension of HEC and MEC studies in adults for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Maltese: Il-profili tar-reazzjonijiet avversi fl-estensjoni taċ-Ċiklu Multiplu tal-istudji ta' HEC u MEC fl-adulti sa 6 ċikli ta' kimoterapija addizjonali kienu ġeneralment simili għal dawk osservati f'Ċiklu 1.
English: The reconstituted and diluted final solution is stable for 24 hours at 25C.
Maltese: Is-soluzzjoni finali rikostitwita u ddilwita hija stabbli għal 24 siegħa f'temperatura ta' 25°C.
English: Day 1 IVEMEND 150 mg intravenously Dexamethasone
Maltese: 150 mg għal ġol-vini
English: uncommon
Maltese: mhux komuni
English: For additional information on the co-administration with corticosteroids, see section 4.5.
Maltese: Għal tagħrif addizjonali fuq l-amministrazzjoni ta' ma' kortikosterojdi, ara sezzjoni 4.5.
English: If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on days 1 and 2.
Maltese: Jekk kortikosterojd, bħal dexamethasone, jingħata flimkien miegħu, agħti 50% tad-doża rrakkomandata tal-kortikosterojd fil-jiem 1 u 2
English: For short term treatment, these findings are considered unlikely to be clinically relevant.
Maltese: Għal trattament fuq perjodu qasir, dawn is-sejbiet huma meqjusa improbabbli li jkunu rilevanti b'mod kliniku.
English: Complete response† Delayed phase‡ Complete response† Overall§
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott
English: Table 1: Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy regimen in adults
Maltese: Tabella 1: Għoti ta' dożi rrakkomandat għall-prevenzjoni ta' nawsja u rimettar assoċjati ma' skeda ta kimoterapija emetoġenika ħafna fl-adulti
English: The frequency categories in the table are based on studies in adults; the observed frequencies in the paediatric studies were similar or lower.
Maltese: Il-kategoriji ta' frekwenza fit-tabella huma bbażati fuq studji fl-adulti; il-frekwenzi osservati fl-istudji pedjatriċi kienu jixxiebhu jew kienu inqas.
English: The most common adverse reaction reported at a greater incidence in patients treated with the aprepitant regimen than with standard therapy in patients receiving MEC was fatigue (1.4 % versus 0.9 %).
Maltese: L-aktar reazzjoni avversa komuni irrapportata f'inċidenza akbar f'pazjenti ittrattati birreġimen ta' aprepitant milli b'terapija standard f'pazjenti li qed jirċievu MEC kienet għeja kbira (1.4 % kontra 0.9 %).
English: Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Maltese: Fosaprepitant kien mibdul rapidament għal aprepitant f'inkubazzjonijiet in vitro bi preparazzjonijiet tal-fwied mill-bnedmin.
English: Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0-∞ of midazolam by 77 % on Day 1 and had no effect on Day 4 when midazolam was co-administered as a single oral dose of 2 mg on Days 1 and 4.
Maltese: Fosaprepitanti 150 mg mogħti bħala doża singola minn ġol-vini fil-Jum 1 żied l-AUC0-∞ ta' midazolam b'77 % fil-Jum 1 u ma kellu l-ebda effett fil-Jum 4 meta midazolam ingħata flimkien miegħu bħala doża singola ta' 2 mg mill-ħalq fil-Jiem 1 u 4.
English: • if you are allergic to fosaprepitant, aprepitant, or to polysorbate 80 or any of the other ingredients (listed in section 6).
Maltese: • jekk inti allerġiku għal fosaprepitant, aprepitant, jew għal polysorbate 80 jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Cardiac disorders palpitations uncommon bradycardia, cardiovascular disorder rare
Maltese: Disturbi fil-qalb palpitazzjonijiet mhux komuni bradikardija, disturb kardjovaskulari rari
English: Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction), - euphoria (feeling of extreme happiness), disorientation, - bacterial infection, fungal infection, - severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating, - frequent urination, passing more urine than normal, presence of sugar or blood in urine, - chest discomfort, swelling, change in the manner of walking, - cough, mucus in back of throat, throat irritation, sneezing, sore throat, - eye discharge and itching, - ringing in the ear, - muscle spasms, muscle weakness, - excessive thirst, - slow heartbeat, heart and blood vessel disease, - lowering of white blood cells, low sodium levels in the blood, weight loss, - hardening of site of infusion.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000) huma: - diffikultà biex taħseb, nuqqas ta' enerġija, disturb fit-togħma, - sensittività tal-ġilda għax-xemx, ħruġ eċċessiv ta' għaraq, ġilda żejtnija, feriti fil-ġilda, raxx li jġiegħlek tħokk, sindrome ta' Stevens-Johnson/nekroliżi tossika tal-epidermide (reazzjoni qawwija rari fil-ġilda), - ewforja (tħoss ferħ kbir), disorjentament, - infezzjoni bil-batterji, infezzjoni bil-moffa, - stitikezza qawwija, ulċera fl-istonku, infjammazzjoni tal-musrana ż-żgħira u l-musrana l-ħoxna,
English: The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see Summary of Product Characteristic (SmPC), section 6.2).
Maltese: Il-prodott mediċinali m'għandux jiġi rikostitwit jew imħallat ma' soluzzjonijiet li għalihom ma ġietx stabbilita kompatibilità fiżika jew kimika (ara sezzjoni 6.2).
English: Paediatric Patients Receiving 1-Day Fosaprepitant Regimen The efficacy of the 1-day fosaprepitant regimen in paediatric patients was extrapolated from that demonstrated in adults receiving the 1-day fosaprepitant regimen as described in the 1-Day Regimen of Fosaprepitant in Adults subsection.
Maltese: L-effikaċja tal-iskeda ta' jum 1 ta' fosaprepitant f'pazjenti pedjatriċi hija mistennija li tkun tixbah dik tal-iskeda ta' jum 1 ta' fosaprepitant fl-adulti.
English: 12 mg orally
Maltese: 12-il mg mill-ħalq
English: Concomitant administration of fosaprepitant with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.
Maltese: John's Wort (Hypericum perforatum) m'hijiex irrikmandata.
English: Avoid shaking and jetting sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.
Maltese: Evita li tħarrek u soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) għal injezzjoni għal ġol-kunjett.
English: IVEMEND 150 mg was shown to be non-inferior to that of the 3-day regimen of aprepitant.
Maltese: IVEMEND 150 mg intwera li ma kienx inferjuri għal dak ta' reġimen ta' 3 ijiem ta' aprepitant.
English: Dexamethasone should also be administered in the evenings on Days 3 and 4.
Maltese: Dexamethasone għandu jingħata wkoll filgħaxijiet fil-Jiem 3 u 4.
English: UAB Merck Sharp & Dohme Tel. + 370 5278 02 47 msd_lietuva@merck.com
Maltese: + 370 5278 02 47 msd_lietuva@merck.com
English: 115 mg intravenously
Maltese: 115-il mg minn ġol-vini
English: In rabbits, fosaprepitant caused initial transient local acute inflammation following paravenous, subcutaneous and intramuscular administration.
Maltese: Fil-fniek, fosaprepitant ikkawża infjammazzjoni inizjali lokali akuta temporanja wara għoti ħdejn ilvini, taħt il-ġilda u ġol-muskoli.
English: Following a single 150 mg fosaprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, everolimus and sirolimus) is expected.
Maltese: Wara doża singola ta' 150 mg fosaprepitant, hija mistennija żieda moderata temporanja għal jumejn possibilment segwita minn tnaqqis ħafif fl-esponiment ta' immunosoppressanti metabolizzati minn CYP3A4
English: Fosaprepitant 150 mg administered as a single intravenous dose on Day 1 increased the AUC0-24hr of dexamethasone, a CYP3A4 substrate, by 100 % on Day 1, 86 % on Day 2 and 18 % on Day 3 when dexamethasone was co-administered as a single 8 mg oral dose on Days 1, 2, and 3.
Maltese: Fosaprepitant 150 mg mogħti bħala doża singola minn ġol-vini fil-Jum 1 żied l-AUC0-24siegħa ta' dexamethasone, li huwa sottostrat ta' CYP3A4, b'100 % fil
English: The safety profile of the 3-day IV fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day fosaprepitant regimen as the low daily trough levels do not significantly increase the exposures on subsequent days.
Maltese: Il-profil ta' sigurtà tal-iskeda ta' 3 ijiem ta' fosaprepitant IV f'pazjenti pedjatriċi hija mistennija li tkun tixbah dik tal-għoti tal-iskeda ta' fosaprepitant f'jum 1 minħabba li l-inqas livelli ta' kuljum tal-mediċina ma jżidux b'mod sinifikanti l-esponimenti fil-jiem sussegwenti.
English: An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded.
Maltese: Interazzjoni ma' prodotti mediċinali kimoterapewtiċi mogħtija mill-ħalq u mmetabolizzati primarjament jew parzjalment permezz ta' CYP3A4
English: In patients with severe renal impairment, the AUC0- of total aprepitant (unbound and protein bound) decreased by 21 % and Cmax decreased by 32 %, relative to healthy subjects.
Maltese: F'pazjenti b'indeboliment renali sever, l-AUC0-∞ ta' aprepitant (mhux marbut u marbut mal-proteina) naqas b'21 % u Cmax naqas b'32 %, fir-rigward ta' suġġetti b'saħħithom.
English: A population pharmacokinetic analysis of aprepitant in paediatric patients (aged 6 months through 17 years) suggests that gender and race have no clinically meaningful effect on the pharmacokinetics of aprepitant.
Maltese: Analiżi farmakokinetika ta' popolazzjoni ta' aprepitant f'pazjenti pedjatriċi (li kellhom minn 6 xhur sa 17-il sena) tissuġġerixxi li s-sess tal-persuna u r-razza m'għandhom l-ebda effett ta' sinifikat kliniku fuq il-farmakokinetika ta' aprepitant.
English: Moderately Emetogenic Chemotherapy (MEC)
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The control regimen consisted of fosaprepitant placebo 150 mg IV on Day 1 in combination with oral ondansetron 8 mg for 2 doses and oral dexamethasone 20 mg. On Days 2 and 3, patients in the control group received 8 mg oral ondansetron every 12 hours.
Maltese: L-iskeda ta' kontroll kienet tikkonsisiti minn plaċebo ta' fosaprepitant 150 mg IV f'Jum 1 flimkien ma' ondansetron 8 mg mogħti mill-ħalq għal 2 dożi u dexamethasone 20 mg mogħti mill-ħalq.
English: Concomitant administration of fosaprepitant with active substances that strongly induce CYP3A4 activity (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital) should be avoided as the combination could result in reductions of the plasma concentrations of aprepitant that may result in decreased efficacy.
Maltese: (eż. rifampicin, phenytoin, carbamazepine, phenobarbital) għandha tiġi evitata peress li lkombinazzjoni tista' twassal għal tnaqqis ta' konċentrazzjonijiet fil-plażma ta' aprepitant li jistgħu jirriżultaw f'effikaċja mnaqqsa.
English: Dexamethasone: The oral dexamethasone dose should be reduced by approximately 50 % when coadministered with fosaprepitant (see section 4.2).
Maltese: Id-doża ta' dexamethasone orali għandha titnaqqas b'madwar 50 % meta tingħata flimkien ma' fosaprepitant (ara sezzjoni 4.2).
English: In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ml and higher, although tests in human whole blood were negative.
Maltese: F'ċelluli taddemm umani maħsulin instabet ukoll evidenza ta' emolisi b'formulazzjonijiet mhux kummerċjali f'konċentrazzjonijiet ta' fosaprepitant ta' 2.3 mg/ml u ogħla, għalkemm it-testijiet fid-demm sħiħ uman kienu negattivi.
English: 150 mg intravenously
Maltese: 150 mg minn ġol-vini
English: Figure 1: Percent of adult patients receiving Moderately Emetogenic Chemotherapy who remain emesis free over time
Maltese: Figura 1: Perċentwal ta' pazjenti adulti li jkunu qed jirċievu Kimoterapija Emetoġenika b'Mod
English: Respiratory, thoracic and mediastinal disorders hiccups common oropharyngeal pain, sneezing, cough, postnasal drip, throat irritation rare
Maltese: Sulluzzu komuni uġigħ fil-ħalq u l-farinġi, għatis, sogħla, imnieħer inixxi għal ġol-ħalq, irritazzjoni talgerżuma rari
English: At the end of the follow-up period (post-dose day 8), up to slight local subacute inflammation was noted following paravenous and intramuscular administration and additional up to moderate focal muscle degeneration/necrosis with muscle regeneration following intramuscular administration.
Maltese: Fi tmiem il-perjodu tal-follow-up (8 ijiem wara l-għoti tad-doża), sa infjammazzjoni ħafifa lokali mhux akuta kienet innutata wara għoti ħdejn il-vini u ġol-muskoli u wkoll sa degenerazzjoni/nekrożi fokali moderata tal-muskolu b'rigenerazzjoni tal-muskolu wara għoti minn ġol-muskoli.
English: Eye disorders conjunctivitis rare
Maltese: Polidipsija rari
English: **N: Number of adult patients included in the intention to treat population.
Maltese: Numru ta' pazjenti adulti li ġew inklużi fil-popolazzjoni bl-intenzjoni li tiġi ttrattata. †
English: The safety profile of fosaprepitant in adult and paediatric patients was generally similar to that observed with aprepitant.
Maltese: Il-profil ta' sigurtà ta' fosaprepitant f'pazjenti adulti u pedjatriċi kien b'mod ġenerali jixbah dak osservat b'aprepitant.
English: Dizziness and fatigue may occur following administration of IVEMEND (see section 4.8).
Maltese: Sturdament u għeja jistgħu jseħħu wara l-għoti ta' IVEMEND (ara sezzjoni 4.8).
English: How to store IVEMEND
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Maltese: Minħabba l-attività antiemetika ta' aprepitant, emesi ikkaġunata minn prodott mediċinali taf ma tkunx effettiva.
English: After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Maltese: Wara rikostituzzjoni u dilwizzjoni, l-istabbilità kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' 25°C.
English: In children and adolescents (6 months to 17 years of age), the recommended dose of IVEMEND is based on the patient's age and weight.
Maltese: Fit-tfal u fl-adolexxenti (6 xhur sa 17-il sena), id-doża rrakkomandata ta' IVEMEND hija bbażata fuq l-età u l-piż tal-pazjent.
English: 4 mg/kg intravenously
Maltese: 4 mg/kg minn ġol-vini
English: Aprepitant after fosaprepitant administration
Maltese: Farmakokinetika f'popolazzjonijiet speċjali
English: Delayed phase No vomiting Overall
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Ear and labyrinth disorders tinnitus rare
Maltese: Disturbi fil-widnejn u fissistema labirintika żarżir fil-widnejn rari
English: Table 10: Pharmacokinetic parameters of aprepitant for 1-day IV fosaprepitant regimen in paediatric patients
Maltese: Parametri farmakokinetiċi ta' aprepitant għall-iskeda ta' jum 1 ta' fosaprepitant IV f'pazjenti pedjatriċi
English: IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
Maltese: IVEMEND għandu jingħata flimkien ma' kortikosterojd u antagonist ta' 5-HT3 kif speċifikat fit-tabelli t'hawn taħt.
English: Further information on Trazimera can be 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: Trazimera is a ‘biosimilar medicine'.
Maltese: Trazimera hija ‘mediċina bijosimili'.
English: Trazimera contains the active substance trastuzumab.
Maltese: Trazimera fih is-sustanza attiva trastuzumab.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Maltese: • kanċer gastriku (fl-istonku) metastatiku, flimkien ma' cisplatin u jew capecitabine jew fluorouracil (mediċini oħra kontra l-kanċer).
English: Laboratory studies comparing Trazimera with Herceptin have shown that the active substance in Trazimera is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Trazimera ma' Herceptin urew li s-sustanza attiva fi Trazimera hija simili ħafna għal dik f'Herceptin f'termini ta' struttura, purità u attività bijoloġika.
English: The active substance in Trazimera, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Maltese: Is-sustanza attiva f'Trazimera, it-trastuzumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex tagħraf u teħel mal-proteina HER2.
English: It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer.
Maltese: Dan jingħata permezz ta' infużjoni (dripp) ġo vina għal 90 minuta kull ġimgħa jew kull 3 ġimgħat għallkanċer tas-sider, u kull 3 ġimgħat għall-kanċer gastriku.
English: The reference medicine for Trazimera is Herceptin.
Maltese: Il-mediċina ta' referenza għal Trazimera hija Herceptin.
English: What are the risks associated with Trazimera?
Maltese: X'inhuma r-riskji assoċjati ma' Trazimera?
English: In this study, 63% of patients given Trazimera had a complete or partial response to treatment compared with 67% of those given Herceptin.
Maltese: F'dan l-istudju, 63 % tal-pazjenti li ngħataw Trazimera kellhom rispons sħiħ jew parzjali għall-kura meta mqabbel ma' 67 % ta' dawk li ngħataw Herceptin.
English: Other information about Trazimera
Maltese: Informazzjoni oħra dwar Trazimera
English: Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li ma jkollhomx reazzjonijiet sinifikanti għall-ewwel infużjoni ta' 90 minuta jistgħu jirċievu infużjonijiet sussegwenti għal 30 minuta.
English: For more information on biosimilar medicines, see here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara hawn.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Trazimera is used before surgery in combination with chemotherapy and then again after surgery on its own;
Maltese: Għal kanċers li huma lokalment avvanzati (inkluż dawk li huma infjammatorji) jew usa' minn 2 cm, Trazimera jintuża qabel il-kirurġija flimkien mal-kimoterapija mbagħad għal darb'oħra wara l-kirurġija waħdu;
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Trazimera has been shown overall to have a comparable quality, safety and effectiveness to Herceptin.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Trazimera wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Herceptin.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Maltese: Billi teħel ma' HER2, trastuzumab tattiva ċ-ċelloli tas-sistema immuni, li mbagħad joqtlu liċ-ċelloli tat-tumur.
English: As for all medicines, data on the use of Trazimera are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Trazimera hija ssorveljata kontinwament.
English: The most common or serious side effects with Trazimera are heart problems, reactions related to the Trazimera infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Maltese: L-effetti sekondarji l-aktar komuni jew serji bi Trazimera huma problemi fil-qalb, reazzjonijiet relatati mal-infużjoni ta' Trazimera, livelli mnaqqsa ta' ċelloli tad-demm (speċjalment taċ-ċelloli bojod taddemm), infezzjonijiet u problemi fil-pulmun.
English: In addition, a main study involving 707 patients with metastatic breast cancer that overexpressed HER2 showed that Trazimera was as effective in treating the condition as Herceptin.
Maltese: Barra minn hekk, studju ewlieni li involva 707 pazjenti b'kanċer tas-sider li jkun għadu fil-bidu li esprima żżejjed minn HER2 wera li Trazimera kien effettiv biex jikkura l-kondizzjoni daqs Herceptin.
English: This means that Trazimera is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Trazimera huwa simili ħafna għal mediċina bijoloġika oħra (il-'mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Maltese: HER2 tiġi espressa żżejjed f'madwar kwart tal-kanċers tas-sider u wieħed minn kull ħames kanċers gastriċi.
English: How is Trazimera used?
Maltese: Kif jaħdem Trazimera?
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Maltese: • kanċer tas-sider li jkun għadu fil-bidu (meta l-kanċer ikun infirex fis-sider jew fil-glandoli taħt iddriegħ iżda mhux f'partijiet oħra tal-ġisem) wara kirurġija, kimoterapija (mediċini għall-kura talkanċer), u radjoterapija (kura bir-radjazzjoni) jekk applikabbli.
English: Studies have also shown that giving Trazimera produces similar levels of the active substance in the body to giving Herceptin.
Maltese: L-istudji wrew ukoll li lgħoti ta' Trazimera jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Herceptin.
English: How does Trazimera work?
Maltese: Trazimera?
English: Side effects reported with Trazimera are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Trazimera huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Other information about Invokana
Maltese: Informazzjoni oħra dwar Invokana