FrancophonIA/ELRC3.0 huggingface dataset:
English: A Phase 3 clinical study was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Maltese: Tlesta studju kliniku ta' Fażi 3 li fih kien hemm involuti 736 mara li għaddew mill-menopawża u li kellhom kanċer tas-sider fi stat avvanzat u li reġgħet tfaċċatilhom il-marda waqt jew wara t-terapija miżjuda endrokrinali jew li l-marda aggravat wara t-terapija endokrinali għal marda avvanzata.
English: Reduced platelet counte
Maltese: Indeboliment tal-kliewi
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Maltese: Total ta' 521 mara ta' qabel/waqt il-menopawża u li għaddew mill-menopawża li kienu għamlu progress fuq jew fi żmien 12-il xahar mit-tlestija tat-terpija endokrinali aġġuvanti jew fuq jew fi żmien xahar minn terapija endokrinali minn qabel għall-marda avvanzata, ġew randomizzati 2:1 għal fulvestrant flimkien ma' palbociclib jew fulvestrant flimkien mal-plaċebo u ġew stratifikati permezz
English: In two short-term studies (1 and 12 weeks) in premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measurement between fulvestrant and placebo groups.
Maltese: F'żewġ studji qosra (1 u 12-il ġimgħa) f'pazjenti ta' qabel l-menopawża b'mard ġinekoloġiku beninn, ma ġewx osservati differenzi fil-ħxuna tal-endometriju imkejjel bl-ultrasound bejn il-grupp ta' fulvestrant u dak tal-plaċebo.
English: Benzyl benzoate
Maltese: Bilirubin għoljaa
English: Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with fulvestrant plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Maltese: Żieda ta' palbociclib għal fulvestrant irriżultat f'benefiċċju tas-sintomi billi ż-Żmien għad-Deterjorazzjoni ġie ttardjat b'mod sinifikanti fis-sintomi tal-uġigħ meta mqabbel ma' fulvestrant u l-plaċebo (medjan 8.0 xhur kontra 2.8 xhur;
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Maltese: U KWANTITATTIVA Siringa mimlija għal-lest b'250 mg fulvestrant f'soluzzjoni ta' 5 mL. Eċċipjenti b'effett magħruf
English: These occurred at exposure levels higher than in patients (Cmax >15 times) and are likely to be of limited significance for human safety at the clinical dose.
Maltese: Dawn seħħew f'livelli ta' espożizzjoni ogħla milli ħadu l-pazjenti (Cmax >15 ildarba) u huma probabbli li jkunu ta' sinifikat limitat għas-sigurtà tal-bniedem fid-doża klinika.
English: This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
Maltese: Din is-sezzjoni tipprovdi informazzjoni fuq ir-reazzjonijiet avversi kollha minn provi kliniċi, studji ta' wara t-tqegħid fis-suq u rapporti spontanji.
English: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Maltese: Minħabba s-similarità strutturali ta' fulvestrant u estradiol, fulvestrant jista' jinterferixxi ma' assaġġi ta' estradiol ibbażati fuq l-antikorpi u dan jista' jwassal għal livelli miżjuda b'mod falz ta' estradiol.
English: Strength Pharmaceutical Form
Maltese: Isem (Ivvintat) Qawwa Għamla Farmaċewtika
English: Immediate Packaging
Maltese: Daqs tal-pakkett mikrogram ma /
English: Route of Administration
Maltese: 22 mikrogra mma
English: The full EPAR for Copalia HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Copalia HCT jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Maltese: Jiġi bħala pilloli li jkun fihom l-amlodipina, il-valsartan u l-idroklorotijażide fl-ammonti li ġejjin: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg u 10/320/25 mg.
English: Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Maltese: Copalia HCT huwa mediċina li fiha t-tliet sustanzi attivi, l-amlodipina, il-valsartan u l-idroklorotijażide.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Copalia HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Maltese: It-tnaqqis medju fil-pressjoni taddemm kien madwar 39.7/24.7 mmHg f'pazjenti li kienu fuq Copalia HCT meta mqabbel ma' 32/19.7 mmHg, 33.5/21.5 mmHg u 31.5/19.5 mmHg f'pazjenti li kienu qegħdin jieħdu valsartan/idroklorotijażide, valsartan/amlodipina u idroklorotijażide/amlodipina rispettivament.
English: The daily dose of Copalia HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Id-doża ta' kuljum ta' Copalia HCT ma għandhiex taqbeż l-10 mg amlodipina, 320 mg valsartan u 25 mg idroklorotijażide.
English: The most common side effects with Copalia HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Maltese: L-effetti sekondarji l-aktar komuni b'Copalia HCT (li dehru f'madwar pazjent 1 u 10 pazjenti f'100) huma ipokaljemija (livelli baxxi ta' potassju fid-demm), sturdament, uġigħ ta' ras, ipotensjoni (pressjoni tad-demm baxxa), dispepsija (qrusa tal-istonku), pollakjurija (frekwenza anormali talawrina), għejja u edema (żamma tal-fluwidi).
English: This is a summary of the European public assessment report (EPAR) for Copalia HCT.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Copalia HCT.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Copalia HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Maltese: Barra minn hekk, sar studju ewlieni f'2,271 pazjent b'ipertensjoni minn moderata għal gravi bl-ogħla konċentrazzjoni ta' Copalia HCT (320 mg valsartan, 10 mg amlodipina u 25 mg idroklorotijażide).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Copalia HCT valida fl-Unjoni Ewropea kollha fl-4 ta' Novembru 2009.
English: What is the risk associated with Copalia HCT?
Maltese: X'inhu r-riskju assoċjat ma' Copalia HCT?
English: Finally, Copalia HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Maltese: Fl-aħħar nett, Copalia HCT ma jistax jintuża f'pazjenti b'ipokalemija (livelli baxxi ta' potassju fid-demm), iponatremija (livelli baxxi ta' sodju fid-demm) u iperkalċemija (livelli għoljin tal-kalċju fid-demm) li ma jirrispondux għall-kura u f'pazjenti b'iperuriċemija (livelli għoljin ta' aċtu uriku fid-demm) li tikkawża s-sintomi.
English: What is Copalia HCT?
Maltese: X'inhu Copalia HCT?
English: Copalia HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Maltese: Copalia HCT jittieħed oralment bħala pillola waħda darba kuljum, fl-istess ħin tal-jum u preferibbilment filgħodu.
English: Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Maltese: Copalia HCT ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal sulfonamidi oħra, għal derivattivi diidropiridiniċi jew għal kwalunkwe ingredjent ieħor f'Copalia HCT.
English: The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Maltese: It-tliet sustanzi attivi f'Copalia HCT huma mediċini antiipertensivi li diġà qegħdin jintużaw fl-Unjoni Ewropea (UE).
English: For all doses, Copalia HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Maltese: Għad-dożi kollha, Copalia HCT issodisfa wkoll ir-rekwiżiti sabiex juri li kien komparabbli malkombinazzjonijiet tas-sustanzi attivi individwali meħuda separatament.
English: Why has Copalia HCT been approved?
Maltese: Għaliex ġie approvat Copalia HCT?
English: For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Copalia HCT, ara l-fuljett ta' tagħrif.
English: The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant is-CHMP iddeċieda li l-benefiċċji ta' Copalia HCT huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Copalia HCT been studied?
Maltese: Kif ġie studjat Copalia HCT?
English: Copalia HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Maltese: Copalia HCT ma għandux jintuża wkoll flimkien ma' mediċini li fihom l-aliskiren (użati wkoll fil-kura talipertensjoni essenzjali) f'pazjenti bid-dijabete tat-tip 2 jew f'pazjenti li jbatu minn insuffiċjenza moderata jew gravi fil-kliewi.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, l-ittikkettar u l-fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba waqt il-proċedura tal-grupp tal-Koordinazzjoni.
English: b L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology c adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
Maltese: b,c a Papillomavirus Uman = HPV b L1 proteina fis-sura ta' partikuli qishom virus prodotti fiċ-ċelluli tal-moffa (Saccharomyces cerevisiae CANADE 3C-5 (Speċi 1895)) minn teknoloġija DNA rikombinanti c adsorbit fuq amorphous aluminium hydroxyphosphate sulphate adjuvant (225 mikrogramma Al)
English: Packaging Content (concentration)
Maltese: Kontenut (konċentrazzjoni
English: 1 1 dose (0.5 ml) contains approximately:
Maltese: 1 doża 1 (0.5 ml) fiha bejn wieħed u ieħor:
English: Human Papillomavirusa Type 6 L1 proteinb,c
Maltese: Proteina tip 16 L1
English: 1 pre-filled syringe + 1 needle
Maltese: 1 siringa mimlija għal-lest + 2 labriet
English: Human Papillomavirusa Type 11 L1 proteinb,c 40 micrograms Human Papillomavirusa Type 16 L1 proteinb,c 40 micrograms Human Papillomavirusa Type 18 L1 proteinb,c 20 micrograms a Human Papillomavirus = HPV
Maltese: 10 siringi mimlijin għal-lest + 20 labra
English: The full EPAR for Lartruvo 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Lartruvo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Lartruvo
Maltese: Informazzjoni oħra dwar Lartruvo
English: This is a summary of the European public assessment report (EPAR) for Lartruvo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lartruvo.
English: The most serious side effects were neutropenia and musculoskeletal pain.
Maltese: L-aktar effetti sekondarji serji kienu n-newtropenja u l-uġigħ muskoloskeletali.
English: The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha' (PDGFRα).
Maltese: Is-sustanza attiva f'Lartruvo, olaratumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' proteina msejħa "platelet-derived growth factor receptor alpha" ("riċettur alfa talfattur ta' tkabbir miksub mill-pjastrina")(PDGFRα).
English: Lartruvo is available as a solution for infusion (drip) into a vein.
Maltese: Lartruvo huwa disponibbli bħala soluzzjoni għall-infużjoni (dripp) fil-vina.
English: Lartruvo has been given ‘conditional approval'.
Maltese: Lartruvo ngħata 'approvazzjoni b'kondizzjoni'.
English: The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8.
Maltese: Id-doża rakkomandata ta' Lartruvo hija ta' 15 mg għal kull kilogramma tal-piż tal-ġisem, li tingħata darbtejn fuq perjodu ta' tliet ġimgħat, f'jum 1 u 8.
English: Why is Lartruvo approved?
Maltese: Għaliex ġie approvat Lartruvo?
English: In addition, patients treated with the combination Lartruvo plus doxorubicin lived overall almost twice as long as patients treated with doxorubicin (26.5 versus 14.7 months, respectively).
Maltese: Barra minn hekk, pazjenti kkurati bil-kombinazzjoni ta' Lartruvo u ż-żieda ta' doxorubicin għexu b'mod ġenerali kważi darbtejn aktar mill-pazjenti kkurati b'doxorubicin (26.5 meta mqabbel ma' 14.7 xhur, rispettivament).
English: Lartruvo olaratumab
Maltese: Sommarju tal-EPAR għall-pubbliku olaratumab
English: Lartruvo has been investigated in one main study involving 133 adults with advanced soft tissue sarcoma who couldn't undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin).
Maltese: Lartruvo ġie investigat fi studju prinċipali wieħed li involva 133 adult b'sarkoma tat-tessuti rotob avvanzata li ma setgħux jiġu operati jew jingħataw radjoterapija u li ma ġewx ikkurati qabel b'antraċiklini (grupp ta' mediċini tal-kanċer li jinkludu doxorubicin).
English: Because the number of patients with soft tissue sarcoma is low, the disease is considered ‘rare', and Lartruvo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 February 2015.
Maltese: Minħabba li l-għadd ta' pazjenti li għandhom sarkoma tat-tessuti rotob huwa baxx, il-marda titqies bħala 'rari', u għaldaqstant, fit-12 ta' Frar 2015, Lartruvo ingħata l-klassifikazzjoni ta' 'mediċina orfni' (mediċina li tintuża f'mard rari).
English: The most common side effects with Lartruvo (which may affect more than 1 in 10 people) include nausea (feeling sick), musculoskeletal pain (bone and muscle pain), neutropenia (low levels of neutrophils, a type of white blood cells that fights infection) and mucositis (inflammation of the body's moist surfaces, most commonly affecting the mouth and throat).
Maltese: L-aktar effetti sekondarji komuni ma' Lartruvo (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 persuni) fosthom dardir (meta wieħed iħossu ma jiflaħx), uġigħ muskoloskeletali (uġigħ flgħadam u fil-muskoli), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċelloli bojod tad-demm li jiġġieled l-infezzjoni) u mikosite (mucositis) (infjammazzjoni tal-uċuħ niedja tal-ġisem, li taffettwa l-aktar il-ħalq u l-gerżuma).
English: Doxorubicin is given on day 1 of each cycle, after the Lartruvo infusion.
Maltese: Doxorubicin jingħata f'jum 1 ta' kull ċiklu, wara l-infużjoni Lartruvo.
English: What information is still awaited for Lartruvo?
Maltese: Liema informazzjoni għadha mistennija għal Lartruvo?
English: Since Lartruvo has been granted a conditional approval, the company that markets Lartruvo will provide additional data from an ongoing study in order to further confirm the efficacy and safety of the medicine.
Maltese: Peress li Lartruvo ngħata approvazzjoni b'kondizzjoni, il-kumpanija li tikkumerċjalizza Lartruvo ser tipprovdi dejta addizzjonali minn studju kontinwu sabiex tikkonferma aktar l-effikaċja u s-sigurtà talmediċina.
English: What are the risks associated with Lartruvo?
Maltese: X'inhuma r-riskji assoċjati ma' Lartruvo?
English: Lartruvo is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels and fat tissue.
Maltese: Lartruvo huwa mediċina kontra l-kanċer użata biex tikkura adulti b'sarkoma tat-tessuti rotob avvanzata, tip ta' kanċer li jaffettwa t-tessuti ta' appoġġ u rotob tal-ġisem bħall-muskoli, il-vażi taddemm u t-tessut tax-xaħam.
English: With regards to the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of side effects; however, in view of the benefits of treatment, side effects were considered tolerable and manageable.
Maltese: Fir-rigward tal-profil tas-sigurtà tal-mediċina, ġie osservat li l-pazjenti kkurati b'Lartruvo biż-żieda ta' doxorubicin esperjenzaw żieda fil-frekwenzi tal-effetti sekondarji; madankollu, fid-dawl tal-benefiċċji tal-kura, l-effetti sekondarji tqiesu bħala tollerabbli u maniġġevoli.
English: For the full list of all side effects and restrictions with Lartruvo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Lartruvo, ara l-fuljett ta' tagħrif.
English: Lartruvo is used together with doxorubicin (another cancer medicine) in patients who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin.
Maltese: Lartruvo jintuża flimkien ma' doxorubicin (mediċina oħra ta' kontra lkanċer) f'pazjenti li ma jistgħux jiġu operati jew jingħataw radjoterapija (kura bir-radjazzjoni) u li ma ġewx ikkurati minn qabel b'doxorubicin.
English: The most frequent side effects which lead to treatment termination were infusion-related reactions (allergic reactions which can be serious, with symptoms such as chills, fever and difficulty breathing) and mucositis.
Maltese: L-aktar effetti sekondarji frekwenti li wasslu għal terminazzjoni tal-kura kienu reazzjonijiet relatati mal-infużjoni (reazzjonijiet allerġiċi li jistgħu jkunu serji, b'sintomi bħal tertir ta' bard, deni u diffikultà fit-teħid tan-nifs) u mikosite.
English: Data from the main study show that Lartruvo in combination with doxorubicin improves progressionfree and overall survival of patients with advanced soft tissue sarcoma.
Maltese: Dejta mill-istudju prinċipali turi li Lartruvo flimkien ma' doxorubicin itejjeb is-sopravivenza mingħajr progressjoni u s-sopravivenza ġenerali tal-pazjenti b'sarkoma tat-tessuti rotob avvanzata.
English: The full EPAR for Herzuma 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: There were no relevant differences in the main measure of effectiveness (absence of invasive cancer cells in the breast or in linked tissues called lymph nodes) between the two products: this was seen in nearly 44% of those given Herzuma (118 of 271) and 47% of those given Herceptin (131 of 278).
Maltese: Ma kien hemm l-ebda differenza rilevanti fil-kejl ewlieni tal-effettività (nuqqas ta' ċelloli tal-kanċer invażivi fis-sider jew tessut marbut imsejjaħ limfonodi) bejn iż-żewġ prodotti: dan deher fi kważi 44 % ta' dawk li ngħataw Herzuma (118 minn 271) u f'47 % ta' dawk li ngħataw Herceptin (131 minn 278).
English: Herzuma is a ‘biosimilar medicine'.
Maltese: Herzuma hija ‘mediċina bijosimili'.
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 ma' capecitabine jew fluorouracil (mediċini oħra tal-kanċer).
English: This is a summary of the European public assessment report (EPAR) for Herzuma.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Herzuma.
English: Herzuma contains the active substance trastuzumab.
Maltese: Herzuma fih is-sustanza attiva trastuzumab.
English: Other information about Herzuma
Maltese: Informazzjoni oħra dwar Herzuma
English: Why is Herzuma approved?
Maltese: Għaliex ġie approvat Herzuma?
English: Laboratory studies comparing Herzuma with Herceptin have shown that the active substance in Herzuma is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Herzuma ma' Herceptin urew li s-sustanza attiva f'Herzuma hija simili ħafna għal dik f'Herceptin f'termini ta' struttura, purità u attività bijoloġika.
English: The active substance in Herzuma, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein.
Maltese: Is-sustanza attiva f'Herzuma, trastuzumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel mal-proteina HER2.
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li jittolleraw l-ewwel infużjoni ta' 90 minuta jistgħu jirċievu infużjonijiet sussegwenti għal 30 minuta.
English: The reference medicine for Herzuma is Herceptin.
Maltese: Il-mediċina ta' referenza għal Herzuma hija Herceptin.
English: This means that Herzuma is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Herzuma huwa simili għal mediċina bijoloġika oħra (il'mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: What are the risks associated with Herzuma?
Maltese: X'inhuma r-riskji assoċjati ma' Herzuma?
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma is used before surgery in combination with chemotherapy and then again after surgery on its own;
Maltese: Għal tumuri li huma lokalment avvanzati (inkluż dawk li huma infjammatorji) jew usa' aktar minn 2 cm, Herzuma jintuża qabel il-kirurġija flimkien malkimoterapija, imbagħad għal darb'oħra wara l-kirurġija waħdu;
English: The most common or serious side effects with Herzuma are heart problems, reactions related to the Herzuma infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Maltese: L-effetti sekondarji l-aktar komuni jew serji b'Herzuma huma problemi fil-qalb, reazzjonijiet relatati mal-infużjoni ta' Herzuma, livelli mnaqqsa ta' ċelloli tad-demm, (speċjalment taċ-ċelloli bojod taddemm), infezzjonijiet u problemi fil-pulmun.
English: The infusion is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer.
Maltese: L-infużjoni tingħata għal 90 minuta kull ġimgħa jew kull tliet ġimgħat għall-kanċer tas-sider, u kull tliet ġimgħat għall-kanċer gastriku.