FrancophonIA/ELRC3.0 huggingface dataset:
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Porcilis Porcoli Diluvac Forte is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs.
Maltese: Porcilis Porcoli Diluvac Forte jingħata f'doża ta' 2 ml b'injezzjoni intramuskulari (fil-muskolu) f'majjali nisa.
English: Other information about Porcilis Porcoli Diluvac Forte:
Maltese: Aktar tagħrif dwar Porcilis Porcoli Diluvac Forte:
English: Porcilis Porcoli Diluvac Forte can cause mild, temporary clinical reactions (fever, lethargy, reduced food intake) during the first 24 hours after vaccination.
Maltese: Porcilis Porcoli Diluvac Forte jista' jikkawża reazzjonijiet temporanji kliniċi (deni, ħedla, inqas ikel) matul l-ewwel 24 siegħa wara l-vaċċinazzjoni.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Porcoli Diluvac Forte, to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria, are greater than any risks.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) qabel li l-benefiċċji ta' Porcilis Porcoli Diluvac Forte biex jitnaqqsu s-sinjali kliniċi u ta' mwiet tal-enterotossikożi kkawżati millbatterja tal-E. coli huma ikbar mir-riskji.
English: What is Porcilis Porcoli Diluvac Forte?
Maltese: Kif jaħdem Porcilis Porcoli Diluvac Forte?
English: Enterotoxicosis is a reaction in the intestines to toxins produced by some bacteria.
Maltese: L-enterotoksikożi hija reazzjoni fl-intestini għall-tossini prodotti minn ftit batterji.
English: Porcilis Porcoli Diluvac Forte contains adhesins that are found on the surface of E. coli bacteria.
Maltese: Porcilis Porcoli Diluvac Forte fih l-adeżini li jinsabu fil-wiċċ tal-batterji tal-E. coli.
English: What are the side effects of Porcilis Porcoli Diluvac Forte?
Maltese: Għaliex ġie approvat Porcilis Porcoli Diluvac Forte?
English: Porcilis Porcoli Diluvac Forte is a vaccine for use in pigs.
Maltese: Porcilis Porcoli Diluvac Forte huwa vaċċin għall-użu fil-ħnieżer.
English: Porcilis Porcoli Diluvac Forte reduced the death rate in all the studies when compared with the control piglets.
Maltese: Porcilis Porcoli Diluvac Forte naqqas ir-rata ta' mwiet fl-istudji kollha meta mqabbel mal-qżieqeż ikkontrollati.
English: This summary was last updated in January-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Jannar 2013.
English: Porcilis Porcoli Diluvac Forte is used to reduce death and clinical signs of enterotoxicosis caused by E. coli bacteria in piglets during the first days of their life.
Maltese: Porcilis Porcoli Diluvac Forte jintuża biex inaqqas l-imwiet u s-sinjali kliniċi tal-enterotoksikożi kkawżata mill-batterja tal-E. coli fi qżieqeż matul l-ewwel jiem ta' ħajjithom.
English: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid)
Maltese: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / aċidu aċetilsaliċiliku)
English: The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription.
Maltese: Il-mediċina tiġi bħala pilloli li jkun fihom 75 mg klopidogrel, jew b' 75 mg jew 100 mg ta' aċidu aċetilsaliċiliku, u tista' tinkiseb biss b'riċetta ta' tabib.
English: Further information on Clopidogrel/Acetylsalicylic acid Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
Maltese: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
English: Other information about Clopidogrel/Acetylsalicylic acid Mylan
Maltese: Informazzjoni oħra dwar Clopidogrel/Acetylsalicylic acid Mylan
English: Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine'.
Maltese: Clopidogrel/Acetylsalicylic acid Mylan fih żewġ sustanzi attivi, il-klopidogrel u l-aċidu aċetilsaliċiliku (magħruf ukoll bħala aspirina) u huwa ‘mediċina ġenerika'.
English: Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Maltese: Clopidogrel/Acetylsalicylic acid Mylan jintuża biex jipprevjeni problemi kkawżati minn emboli tad-demm u minn twebbis tal-arterji bħall-attakki tal-qalb, f'adulti li jkunu diġà qegħdin jieħdu kemm ilklopidogrel kif ukoll l-aċidu aċetilsaliċiliku bħala pilloli separati.
English: • patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on an electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Maltese: • pazjenti li jkollhom anġina instabbli (tip ta' wġigħ sever fis-sider) jew kellhom attakk tal-qalb b'ebda ‘elevazzjoni tas-segment ST' (qari anormali fuq l-elettrokardjogramma), inklużi dawk li għandhom stent (tubu qasir) imdaħħal fl-arterja biex jipprevjeniha milli tagħlaq;
English: Because Clopidogrel/Acetylsalicylic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Clopidogrel/Acetylsalicylic acid Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għallmediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid.
Maltese: Il-klopidogrel ilha awtorizzata mill1998 bħala mediċina antipjastrina, u ta' spiss tintuża f'kombinazzjoni mal-aċidu aċetilsaliċiliku.
English: Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase.
Maltese: L-aċidu aċetilsaliċiliku jimblokka l-enzima msejħa prostaglandina ċikloossiġenasi.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument bilmistoqsijiet u t-tweġibiet hawnhekk.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanzi attivi fl-użi awtorizzati bil-mediċina ta' referenza, DuoPlavin, u m'għandhomx għalfejn jiġu ripetuti għal Clopidogrel/Acetylsalicylic acid Mylan.
English: Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Clopidogrel/Acetylsalicylic acid Mylan huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What are the benefits and risks of Clopidogrel/Acetylsalicylic acid Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Clopidogrel/Acetylsalicylic acid Mylan?
English: As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Clopidogrel/Acetylsalicylic acid Mylan hija ssorveljata kontinwament.
English: How is Clopidogrel/Acetylsalicylic acid Mylan used?
Maltese: Kif ġie studjat Clopidogrel/Acetylsalicylic acid Mylan?
English: Multi-dose vial (glass)
Maltese: Mnejn jingħata
English: Ref. EMEA/654674/2009 EMEA/H/C/994
Maltese: EMEA/745160/2009 EMEA/H/C/994
English: What is Opaxio?
Maltese: Opaxio?
English: It contains the active substance paclitaxel poliglumex.
Maltese: Fih is-sustanza attiva paclitaxel poliglumex.
English: Paclitaxel is an anticancer medicine which has been available in the European Union since 1993.
Maltese: Paclitaxel huwa mediċina ta' kontra l-kanċer li ilha disponibbli fl-Unjoni Ewropea sa mill-1993.
English: On 21 September 2009, CTI Life Sciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opaxio, for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Maltese: Fil-21 ta' Settembru 2009, CTI Life Sciences Ltd innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Opaxio, għat-trattament tal-ewwel linja ta' pazjenti b'kanċer avvanzat taċ-ċelloli mhux żgħar tal-pulmun li għandhom status ta' prestazzjoni ECOG ta' 2.
English: In Opaxio, paclitaxel is attached to poliglumex to make it more soluble.
Maltese: F'Opaxio, paclitaxel huwa mwaħħal ma' poliglumex biex jagħmlu aktar solubbli.
English: The active substance in Opaxio, paclitaxel poliglumex, is expected to be converted into paclitaxel in the cancer cells.
Maltese: Is-sustanza attiva f'Opaxio, paclitaxel poliglumex, hija mistennja li tiġi kkonvertita f'paclitaxel fiċċelloli tal-kanċer.
English: How is Opaxio expected to work?
Maltese: X'inhu Opaxio?
English: The CHMP also had concerns about the side effects of the medicine, especially neuropathy (damage to the nerves) and unexplained deaths.
Maltese: Is-CHMP wera tħassib ukoll dwar l-effetti sekondarji tal-mediċina, b'mod speċjali newropatija (ħsara lin-nervituri) u mwiet mingħajr spjegazzjoni.
English: However, outside the EU, the company is continuing to study Opaxio in several cancers including ovarian, oesophageal and non-small cell lung cancer.
Maltese: Madankollu, barra l-UE, il-kumpanija qiegħda tkompli tistudja Opaxio f'bosta kanċers inkluż talovarji, tal-esofagu u l-kanċer taċ-ċelloli mhux żgħar tal-pulmun.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Opaxio could not have been approved for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Maltese: Abbażi tal-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Opaxio ma setgħax ikun approvat għat-trattament tal-ewwel linja ta' pazjenti b'kanċer avvanzat taċ-ċelloli mhux żgħar talpulmun li għandhom stat ta' prestazzjoni ECOG ta' 2.
English: Opaxio is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: Opaxio huwa trab li jkun magħmul f'soluzzjoni għall-infużjoni (dripp fil-vina).
English: The company presented results of one main study involving 477 patients with advanced non-small cell lung cancer and a performance status of 2.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni li kien jinvolvi 477 pazjent b'kanċer avvanzat taċ-ċelloli mhux żgħar tal-pulmun u stat ta' prestazzjoni ta' 2.
English: Questions and answers on the withdrawal of the marketing authorisation application for Opaxio paclitaxel poliglumex
Maltese: L-ittra mill-kumpanija li tgħarraf lill-EMEA dwar l-irtirar tal-applikazzjoni tinsab hawn
English: The effects of Opaxio were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Opaxio għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The CHMP moved the statement from Section 4.4 to Section 5.1.
Maltese: Is-CHMP mexxa ddikjarazzjoni minn Sezzjoni 4.4 għal Sezzjoni 5.1.
English: The CHMP noted the pivotal study for the adjuvant treatment indication, BIG 1-98, coordinated by the collaborative group IBCSG (International Breast Cancer Study Group) and the parent organization BIG (Breast International Group), which specifically excluded patients who did not have a confirmed diagnosis of invasive breast cancer.
Maltese: Is-CHMP innota l-istudju pivitali għall-indikazzjoni tal-kura adjuvanti, BIG 1-98, ikkoordinat millgrupp kollaborattiv IBCSG (International Breast Cancer Study Group) u l-organizzazzjoni prinċipali BIG (Breast International Group), li b'mod speċifiku eskluda pazjenti li ma kellhomx dijanjosi kkonfermata ta' kanċer invażiv tas-sider.
English: The CHMP therefore considered it justified to qualify the indication with “invasive”.
Maltese: Is-CHMP għalhekk ħass li kien ġustifikat li jikkwalifika l-indikazzjoni bitterminu “invażiv”.
English: In addition, no studies on DCIS (ductal carcinoma in situ) or LCIS (lobular carcinoma in situ) patients have been performed.
Maltese: Barra minn hekk, ma sarux studji fuq pazjenti b'DCIS (ductal carcinoma in situ) jew LCIS (lobular carcinoma in situ).
English: The CHMP defined the target patient population as women of established postmenopausal status and patients with ER-positive tumours, patients whose tumours are HER-2 (Human Epidermal Growth Factor Receptor 2) negative and patients who are unable to tolerate or who refuse to take neoadjuvant chemotherapy as well as patient for whom immediate surgery is not an option.
Maltese: Is-CHMP iddefinixxa l-popolazzjoni ta' pazjenti fil-mira bħala nisa bi status stabbilit ta' wara l-menopawsa u pazjenti b'tumuri ER-pożittivi, pazjenti li t-tumuri tagħhom huma negattivi għall-HER-2 (Human Epidermal Growth Factor Receptor 2) u pazjenti li ma jistgħux jittolleraw jew li jirrifjutaw li jieħdu kemjoterapija neoadjuvanti kif ukoll pazjenti li għalihom ilkirurġija immedjata ma tkunx għażla.
English: Section 4.2 - Posology and Method of Administration
Maltese: Sezzjoni 4.6 - Tqala u treddigħ
English: The CHMP reviewed all available data and considered that letrozole has shown significant superiority to tamoxifen in clinical response rate, mammographic response rate, breast ultrasound response rate and rate of breast-conserving surgery (BCS).
Maltese: Is-CHMP analizza d-dejta kollha disponibbli u qies li letrozole wera superjorità sinifikanti għal tamoxifen fir-rata ta' rispons kliniku, ir-rata ta' rispons mammografiku, ir-rata ta' rispons fl-ultrasound tas-sider u r-rata ta' kirurġija ta' konservazzjoni tas-sider (BCS).
English: Femara was first approved in the European Union (EU) in 1996 and is available as a 2.5 mg film-coated tablet.
Maltese: Femara ġie approvat l-ewwel darba fl-Unjoni Ewropea (UE) fl-1996 u jiġi bħala pillola miksija b'rita ta' 2.5 mg.
English: The CHMP instead included a warning in Section 4.4 stating that safety data in patients with significant organ impairment are lacking.
Maltese: IsCHMP inkluda minflok twissija f'Sezzjoni 4.4 li tgħid li hemm nuqqas ta' dejta dwar is-sigurtà f'pazjenti b'indeboliment sinifikanti tal-organi.
English: A referral under Article 30(2) of Directive 2001/83/EC, as amended was therefore triggered to resolve these divergences and thus harmonise the product information (PI) across the EU.
Maltese: Għalhekk inbeda riferiment skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE, kif emendata sabiex jiġu solvuti dawn id-diverġenzi u b'hekk tiġi armonizzata l-informazzjoni dwar ilprodott (PI) fl-UE kollha.
English: For Section 5.1Pharmacodynamic Properties, the wording was substantially shortened to focus on information relevant to the prescriber for the approved indications.
Maltese: Għal Sezzjoni 5.1Proprjetajiet farmakodinamiċi, il-kitba ġiet imqassra b'mod sostanzjali sabiex tiffoka fuq informazzjoni rilevanti għal min jippreskrivi għall-indikazzjonijiet approvati.
English: Regarding neoadjuvant treatment, recent studies investigating duration of therapy show higher response rates and more patients becoming suitable for BCS at 4-8 months, with very little incremental benefit beyond that and that the minimum duration is 4-6 months.
Maltese: Rigward il-kura neoadjuvanti, studji reċenti li investigaw id-dewmien tat-terapija juru rati ta' rispons ogħla u numru akbar ta' pazjenti li jsiru adatti għal BCS wara 4-8 xhur, bi ftit li xejn benefiċċju inkrimentali wara dak u li d-dewmien minimu huwa 4-6 xhur.
English: The CHMP reviewed the potential for interaction of a number of substances, including cimetidine and anti-cancer agents, as well as the role played by CYP2A6 and CYP3A4 in the metabolism of letrozole.
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Is-CHMP eżamina l-potenzjal għall-interazzjoni ta' numru ta' sustanzi, fosthom cimetidine u sustanzi kontra l-kanċer, kif ukoll ir-rwol li għandhom CYP2A6 u CYP3A4 fil-metaboliżmu ta' letrozole.
English: A statement recommending against the use of Femara for patients with problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption was also added.
Maltese: Żdiedet ukoll dikjarazzjoni li tirrakkomanda kontra l-użu ta' Femara għal pazjenti li jkollhom problemi ta' intolleranza għallgalactose, defiċjenza severa ta' lactase jew assorbiment ħażin tal-glucose-galactose.
English: 2) Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Maltese: 2) Kura adjuvanti estiża ta' kanċer invażiv tas-sider dipendenti fuq l-ormoni f'nisa li qabżu lmenopawsa li jkunu rċevew terapija adjuvanti standard preċedenti b'tamoxifen għal 5 snin.
English: Regarding renal impairment, the CHMP noted the available pharmacokinetics report and observed that letrozole is mainly cleared by the hepatic metabolism, with renal clearance reported to be less than 5%.
Maltese: Rigward l indeboliment tal-kliewi, is-CHMP innota r-rapport farmakokinetiku disponibbli u osserva li letrozolejitneħħa prinċipalment bil-metaboliżmu tal-fwied, bit-tneħħija mill-kliewi tkun irrappurtata li hija inqas minn 5%.
English: Femara contains letrozole, an aromatase inhibitor which inhibits the conversion of androgens to oestrogens.
Maltese: Femara fih letrozole, inibitur aromatase li jimpedixxi l-bdil tal-androġeni f'estroġeni.
English: Regarding the description of selected adverse reactions, the CHMP agreed to separate the metastatic, adjuvant and extended adjuvant indications.
Maltese: Rigward id-deskrizzjoni ta' reazzjonijiet avversi magħżula, isCHMP qabel li jifred l-indikazzjonijiet metastatiċi, adjuvanti u adjuvanti estiżi.
English: Having considered the data submitted by the Marketing Authorisation Holder, the rapporteur and co-rapporteur assessment reports and the scientific discussions within the Committee, the CHMP was of the opinion that the benefit-risk ratio of Femara and associated names is favourable.
Maltese: Wara li kkunsidra d-dejta sottomessa mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, ir-rapporti ta' valutazzjoni mir-rapporteur u mill-korapporteur u d-diskussjonijiet xjentifiċi fi ħdan il-Kumitat, is-CHMP kien tal-fehma li l-proporzjon tal-benefiċċju-riskju ta' Femara u ismijiet assoċjati huwa favorevoli.
English: Regarding hepatic impairment, the CHMP noted that studies have shown that Femara is safe in mild to moderate hepatic insufficiency but that there is limited experience of use in patients with severely impaired hepatic function, non-cancer patients with liver cirrhosis and/or Child-Pugh stage C liver insufficiency.
Maltese: Rigward l-indeboliment tal-fwied, is-CHMP innota li l-istudji wrew li Femara huwa sigur f'insuffiċjenza ħafifa sa moderata tal-fwied iżda hemm esperjenza limitata talużu f'pazjenti b'indeboliment sever fil-funzjoni tal-fwied, pazjenti mhux morda bil-kanċer li kellhom ċirrożi tal-fwied u/jew insuffiċjenza tal-fwied ta' Child-Pugh stadju C.
English: Regarding “invasive”, it is not common practice to prescribe aromatase inhibitors to patients with no invasive component.
Maltese: Rigward “invażiv”, mhijiex prattika komuni li jiġu preskritti inibituri aromatase lil pazjenti bl-ebda komponent invażiv.
English: The CHMP noted that while elimination of metabolites is expected to be slower in patients with renal impairment, the available data show that this did not affect the safety profile and did not alter pharmacokinetics in patients with severe renal impairment.
Maltese: Is-CHMP innota li filwaqt li t-tneħħija tal-metaboliti hija mistennija li tkun aktar bilmod f'pazjenti b'indeboliment tal-kliewi, id-dejta disponibbli turi li dan ma affettwax il-profil tassigurtà u ma bidilx l-farmakokinetika f'pazjenti b'indeboliment sever tal-kliewi.
English: Femara was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product.
Maltese: Femara ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC), minħabba ddeċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri rigward l-awtorizzazzjoni tal-prodott hawn fuq imsemmi.
English: The neoadjuvant (pre-operative) treatment indication represented the major deviation across the nationally approved SmPCs, as it was approved in some member states in 2001 but the application was withdrawn in others, primarily because neoadjuvant endocrine treatment was not a validated concept at the time and because the results of the pivotal adjuvant study were not yet available.
Maltese: L-indikazzjoni tal-kura neoadjuvanti (ta' qabel l-operazzjoni) kienet tirrappreżenta d-devjazzjoni prinċipali bejn l-SmPCs approvati b'mod nazzjonali, billi din ġiet approvata f'xi stati membri fl-2001 iżda l-applikazzjoni ġiet irtirata f'oħrajn, prinċipalment minħabba li l-kura endokrinali neoadjuvanti ma kinitx kunċett validat f'dak iż-żmien u minħabba li r-riżultati tal-istudju pivitali dwar l-adjuvanti kienu għadhom mhumiex disponibbli.
English: The CHMP considered the term “hormone-dependent” to be justified, as letrozole has no efficacy in hormone receptor negative breast cancer.
Maltese: Is-CHMP ikkunsidra t-terminu “dipendenti fuq l-ormoni” bħala ġustifikat, billi letrozole m'għandu lebda effikaċja f'kanċer tas-sider negattiv għar-riċetturi tal-ormoni.
English: Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Maltese: Kura neoadjuvanti ta' nisa li qabżu l-menopawsa li jkollhom kanċer tas-sider pożittiv għarriċetturi tal-ormoni, negattiv għall-HER-2 fejn il-kemjoterapija ma tkunx adatta u ma tkunx indikata kirurġija immedjata.
English: In the absence of clinical trials, the CHMP therefore concluded that the safety and efficacy of Femara in this population is not established.
Maltese: Fin-nuqqas ta' provi kliniċi, is-CHMP għalhekk ikkonkluda li s-sigurtà u l-effikaċja ta' Femara f'din il-popolazzjoni mhumiex stabbiliti.
English: Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Maltese: • Kura adjuvanti estiża ta' kanċer invażiv tas-sider dipendenti fuq l-ormoni f'nisa li qabżu lmenopawsa li jkunu rċevew terapaija adjuvanti standard preċedenti b'tamoxifen għal 5 snin.
English: Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with antioestrogens.
Maltese: • Kanċer tas-sider avanzat wara tfaċċar mill-ġdid jew progressjoni tal-marda, f'nisa bi status endokrinali naturali jew indott b'mod artifiċjali ta' wara l-menopawsa, li jkunu ġew ikkurati qabel b'antiestroġeni.
English: In particular, for Section 4.8 - Undesirable Effects, the wording was significantly shortened and condensed.
Maltese: B'mod partikolari, għal Sezzjoni 4.8 - Effetti mhux mixtieqa, il-kitba ġiet imqassra u kondensata b'mod sinifikanti.