FrancophonIA/ELRC3.0 huggingface dataset:
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil * Un-adjusted log-rank test ** Un-adjusted log-rank test, not adjusted for multiple comparisons *** Chi-square test, not adjusted for multiple comparisons NA-not applicable
Maltese: L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + fluorouracil *Log-rank test mhux aġġustat **Logrank test mhux aġġustat, mhux aġġustat għal paraguni multipli ***Chi-square test, mhux aġġustat għal paraguni multipli NA - Ma jgħoddx f'dan il-każ.
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
Maltese: li ngħata siegħa wara doxorubiċin 50 mg/m2 u cyclophosphamide 500 mg/m2 (539 pazjent fid driegħ ta' FAC), bħala terapija adjuvanti ta' pazjenti bil-kanċer tas-sider negattiv għal glandoli li jista' jiġi operat b'riskju għoli ta' rkadar skont il-kriterji tal-1998 ta' St Gallen (daqs tat-tumur >2 u/jew ER negattiv u PR u/jew grad istoloġiku /nukleari għoli (grad 2 sa 3) u/jew < 35 sena).
English: Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Maltese: Kull kaxxa fiha kunjett wieħed ta' Docetaxel Teva (20 mg) u kunjett wieħed ta' solvent korrispondenti għal Docetaxel Teva, f'kartuna.
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Maltese: Pazjenti li kellhom newtropenja bid-deni u/jew infezzjoni newtropenika għandu jkollhom id-doża tagħhom ta' docetaxel imnaqqsa għal 60 mg/m2 f'kull ċiklu sussegwenti (ara sezzjonijiet 4.4 u 4.8).
English: Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80.
Maltese: Docetaxel Teva 80 mg/2.88 ml konċentrat għal soluzzjoni għall-infużjoni, hija taħlita ċara u magħquda, safra jew safra tagħti fil-kannella, u li għandha 27.
English: The median TTP was 37.3 weeks (95% CI:33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm.
Maltese: • Iż-żmien tal-progressjoni (ŻTP) kien sinifikament itwal fil-fergħa AT kontra l-fergħa AC, p=0.0138. Iż-ŻTP medjan kien 37.3 ġimgħat (95% CI: 34.4-42.1) fil-fergħa AT u 31.9 ġimgħat (95% CI: 27.4-36.0) fil-fergħa AC.
English: Peripheral motor neuropathy (G3/4: 2.5%)
Maltese: Newropatija periferika tal-movimenti (G3/4: 2%)
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4%) in TAC arm and 5 patients (1.0%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-amenorreja li bdiet matul il-perijodu ta' trattament u li baqgħet tippersisti fil-perijodu ta' osservazzjoni ġiet osservata li kienet baqgħet għaddejja fi 18-il pazjent (3.4 %) fil-fergħa ta' TAC u f' 5 pazjenti (1.0 %) fil-fergħa ta' FAC.
English: Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Maltese: Id-data mill-istudju ta' ċentri multipli, fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu x'mediċini qed jintużaw, u l-pazjenti tqassmu mingħajr għażla, isaħħu l-użu ta' docetaxel għattrattament miżjud f'pazjenti li għandhom kanċer tas-sider li nfirex fil-glandoli limfatiċi u li huwa operabbli b'KPS ta' ≥80%, minn 18 sa 70 sena fl-età.
English: PF).
Maltese: PC:
English: 1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
Maltese: F'dan l-istudju, 255 pazjent kienu mqassmin, b'mod każwali, għall-kura b'docetaxel (75 mg/m2 bħala infużjoni fil-vini fuq perijodu ta' siegħa, kull 3 ġimgħat) u capecitabine (1,250 mg/m2 darbtejn kuljum għal ġimgħatejn, segwit b'perijodu ta' waqfien għal ġimgħa). 256 pazjent kienu mqassmin, mingħajr għażla, għall-kura b'docetaxel biss (100 mg/m2 bħala infużjoni fil-vini fuq perjodu ta' siegħa kull 3 ġimgħat).
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Maltese: III, t'għamla komparattiva u magħmula mingħajr għażla, fejn kien hemm total ta' 326 suġġetti fejn it-trattament oriġinali kien b'sustanzi ċitotossiċi alkylating u 392 oħra li kienu ittrattati oriġinarjament b'sustanza anthracycline, b'falliment tal-kura fiż-żewġ gruppi u li ttnejn kellhom kanċer tas-sider metastatiku.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Maltese: Kienu rrappurtati każijiet ta 'żbilanċ elettrolitiku.
English: Epistaxis (G3/4: 0%);
Maltese: Sinkope (G3/4: 0%);
English: Hearing impaired (G3/4: 0%)
Maltese: Żieda fil-piż (G3/4: 0.%)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT - SOLVENT 80 mg/2.88 ml
English: Second primary malignancies (including acute myeloid leukemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Maltese: Tumuri malinni primarji sussegwenti (li jinkludu lewkimja mijelojde akuta, sindrome mijelodisplastika u limfoma mhux ta' Hodgkin) jistgħu jseħħu diversi xhur jew snin wara t-terapija li jkun fiha docetaxel.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
Maltese: 2.88 ml (Mili: 3.40 ml)
English: What the solvent vial contains:
Maltese: Is-solvent:
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Maltese: Għall-modifikazzjonijiet fid-dożi ta' cisplatin u 5-fluorouracil, ara s-sommarju tal-karatteristiċi tal-prodott li jikkorrispondi.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari għat-terapija miżjuda b'Docetaxel 75 mg/m2 użat flimkien ma' doxorubicin u cyclophospahmide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: Patients should be monitored for second primary malignancies (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal tumuri malinni primarji sussegwenti (ara sezzjoni 4.8).
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Fġir l-imnieħer; Uġigh fil farinġi u l-larinġi; Farinġite tal-parti nażali; Qtugħ ta' nifs; Sogħla; Tnixxija mill-imnieħer
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophospamide CI = confidence interval
Maltese: doxorubicin, 5-fluorouracil u/ jew cyclophosphamide.
English: Hand-foot syndrome (G3/4: Alopecia (G3/4: 6%);
Maltese: Is-Sindrome tal-Id u s-Sieq (G3/4: 24%);
English: Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p=0.002).
Maltese: 0043). Sopravivenza totali wara 10 snin kienet kibret b'mod sinifikattiv b'TAC meta mqabbla ma' FAC (76% kontra 69% rispetivament) li tfisser riskju assolut tal-mewt imnaqqas b'7% (p = 0.002).
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent MedDRA system organ classes
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel 100 mg/m² użat flimkien ma' trastuzumab
English: Vomiting (G3/4:
Maltese: Sturdament (G3/4:
English: Nausea (G3/4: 9.6%);
Maltese: Anemija (G3/4: 9.2%);
English: Docetaxel in combination with trastuzumab
Maltese: Deskwamazzjoni talġilda
English: Infection (G3/4: 3.6%)
Maltese: Arritmija (G3/4: 0.6%)
English: Constipation (G3/4: 0.4%)
Maltese: Arritmija (G3/4: 0.2%)
English: malignant and unspecified (incl cysts and polyps) Blood and lymphatic system disorders
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva 20 mg/0.72 ml
Maltese: Meta jiżdied is-solvent kollu fil-kunjett ta'Docetaxel Teva 20 mg/0.
English: Prophylactic G-CSF should be used to mitigate the risk of haematological toxicities (see also Dose adjustments during treatment).
Maltese: Il-profilassi bil-G-CSF għandha tintuża biex tnaqqas ir-riskju ta' effetti tossiċi ematoloġiċi (Ara ukoll l-Aġġustamenti fid-doża waqt it-trattament).
English: Anorexia (G3/4: 1%); Decreased appetite
Maltese: Disturbi tal-metaboliżmu u n-nutrizzjoni Anoreksja (G3/4: 1%); Aptit imnaqqas
English: [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bil-kimoterapija (%) (95%CI) ***p-value
English: • For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m².
Maltese: • Għal dawk il-pazjenti li titfaċċalhom għat-tieni darba t-tossiċità ta' Grad 2, jew it-tossiċità ta' Grad 3 għall-ewwel darba, f'kwalunkwe ħin waqt iċ-ċiklu tat-trattament , ittardja t-trattament sakemm it-tossiċità tinżel għal Grad 0 sa 1 u mbagħad kompli t-trattament b'docetaxel 55 mg/m2.
English: In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Maltese: F'dawk il-pazjenti li fil-bidu qegħdin jieħdu docetaxel 75 mg/m2, flimkien ma' cisplatin, u meta lgħadd tal-plejtlits laħaq il-livell baxx (in-nadir) ta' < 25,000 ċelluli/mm3, waqt il-kors preċedenti ta' terapija, jew f'pazjenti li jiżviluppaw id-deni flimkien ma' newtropenija, jew f'dawk il-pazjenti li għandhom effetti tossiċi u serji mhux ematoloġiċi, id-doża ta' docetaxel f' sussegwenti għandha titnaqqas għal 65 mg/m2.
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
Maltese: F'pazjenti li kellhom jew id-deni flimkien man-newtropenija, b'għadd ta' newtrofili ta' <500 ċelluli/mm3 għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil-ġilda, jew newropatija severa u periferika, waqt it-terapija bid-docetaxel, id-doża ta' docetaxel trid titnaqqas minn 100 mg/m2 għal 75 mg/m2 u/jew minn 75 għal 60 mg/m2.
English: Dysgeusia (G3/4: 0%)
Maltese: Nuqqas ta' smigħ (G3/4: 0%)
English: Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4:
Maltese: Infezzjoni (G3/4: 3.3%) Disturbi tad-demm u tas-sistema limfatika Newtropenija (G3/4: 32%); Anemija (G3/4: 4.9%)
English: • The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Maltese: 72 ml fih soluzzjoni ta' docetaxel f'polysorbate 80 b'konċentrazzjoni ta' 27.73 mg/ml.
English: There is no relevant use of Docetaxel Teva in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Maltese: M'hemmx użu rilevanti għal Docataxel Teva fil-popolazzjoni pedjatrika fl-indikazzjonijiet għall-kanċer tas-sider, kanċer mikroċitoma tal-pulmun, karċinoma tal-prostata, kanċer tar-ras u tal-għonq, li ma jinkludix karċinoma nażofarinġeali ta' tip II u III li hu inqas divrenzjat.
English: These measures will help to protect the environment.
Maltese: li tista' tkun aktar severa.
English: Vizimpro (dacomitinib)
Maltese: Vizimpro (dakomitinib)
English: Vizimpro is available as tablets (15, 30 and 45 mg).
Maltese: Vizimpro jiġi bħala pilloli (15, 30 u 45 mg).
English: Vizimpro (dacomitinib) EMA/89209/2019
Maltese: Vizimpro (dakomitinib) EMA/89209/2019
English: Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Maltese: Aktar informazzjoni dwar Vizimpro tinstab fis-sit elettroniku talAġenzija: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
English: Vizimpro contains the active substance dacomitinib.
Maltese: Vizimpro fih is-sustanza attiva dakomitinib.
English: Other information about Vizimpro
Maltese: Informazzjoni oħra dwar Vizimpro
English: The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Vizimpro (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma dijarea, raxx, stomatite (infjammazzjoni tal-kisja tal-ħalq), disturb tad-dwiefer, ġilda xotta, telf ta' aptit, konġuntivite (ħmura u skumdità fl-għajn), piż u telf ta' xagħar, ħakk, livelli elevati ta' transaminases (sinjal ta' problemi tal-fwied) u nawżja (tħossok ma tiflaħx).
English: involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib.
Maltese: Fi studju ewlieni wieħed li involva 452 pazjent b'mutazzjonijiet EGFR, il-pazjenti li ngħataw Vizimpro għexu bħala medja għal madwar 15-il xahar mingħajr ma l-marda tagħhom marret għallagħar, meta mqabbel ma' 9 xhur għal dawk li ngħataw gefitinib.
English: What are the risks associated with Vizimpro?
Maltese: X'inhuma r-riskji assoċjati ma' Vizimpro?
English: The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Vizimpro, id-dakomitinib, tagħmel parti minn grupp ta' mediċini kontra l-kanċer msejħa inibituri tat-tirożina kinażi.
English: It blocks the activity of EGFR, which normally controls growth and division of cells.
Maltese: Din timblokka l-attività tal-EGFR, li normalment tikkontrolla ttkabbir u d-diviżjoni taċ-ċelluli.
English: The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Maltese: L-effetti sekondarji serji laktar frekwenti huma dijarea, marda interstizjali fil-pulmun (disturbi li jikkawżaw ċikatriċi fil-pulmun), raxx u telf ta' aptit.
English: As for all medicines, data on the use of Vizimpro are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vizimpro hija ssorveljata kontinwament.
English: How is Vizimpro used?
Maltese: Vizimpro?
English: Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
Maltese: Vizimpro huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti b'kanċer tal-pulmun b'ċelloli mhux żgħar (NSCLC) meta l-marda tkun avvanzata jew tkun infirxet.
English: Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Maltese: Vizimpro jintuża waħdu u biss f'pazjenti b'ċerti mutazzjonijiet (bidliet) fil-ġene għal proteina msejħa riċettur tal-fattur tat-tkabbir epidermali (EGFR).
English: For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Vizimpro, ara l-fuljett ta' tagħrif.
English: Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Vizimpro huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Maltese: Billi timblokka l-EGFR, id-dakomitinib tgħin sabiex tnaqqas it-tkabbir u t-tifrix tal-kanċer.
English: The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable.
Maltese: Il-pazjent għandu normalment jieħu pillola ta' 45 mg darba kuljum, fl-istess ħin kuljum, sakemm dan jibbenefika minnu u l-effetti sekondarji jkunu tollerabbli.
English: EMA/177547/2013 EMEA/H/C/002429
Maltese: 21 ta' Marzu 2013 EMA/275095/2013 EMEA/H/C/002429
English: The company that applied for authorisation is Genzyme Europe B.V.
Maltese: Ilkumpanija li applikat għal awtorizzazzjoni hija Genzyme Europe B.V.
English: Kynamro is a medicine that contains the active substance mipomersen.
Maltese: Kynamro huwa mediċina li fiha s-sustanza attiva mipomersen.
English: What is Kynamro?
Maltese: X'inhu Kynamro?
English: Refusal of the marketing authorisation for Kynamro (mipomersen)
Maltese: Kynamro (mipomersen)
English: The active substance in Kynamro, mipomersen, is an ‘antisense oligonucleotide', a very short fragment of DNA designed to block the production of a protein called apolipoprotein B, by attaching to the genetic material of cells responsible for producing it. Apolipoprotein B is the main component of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', and of two closely related types of cholesterol called ‘intermediate density lipoprotein' (IDL) and ‘very low density lipoprotein' (VLDL) cholesterol.
Maltese: L-apolipoproteina B hija l-komponent ewlieni ta' kolesterol b'‘lipoproteina ta' densità baxxa' (LDL), magħruf b'mod komuni bħala ‘kolesterol ħażin', u ta' żewġ tipi ta' kolesterol relatati mill-qrib imsejħa kolesterol b'‘lipoproteina ta' densità intermedjarja' (IDL) u b'‘lipoproteina ta' densità baxxa ħafna' (VLDL).
English: One involved 51 patients with homozygous familial hypercholesterolaemia and the other involved 58 patients with severe heterozygous familial hypercholesterolaemia.
Maltese: F'wieħed ħadu sehem 51 pazjent b'iperkolesterolemija omozigota familjali u fl-ieħor ħadu sehem 58 pazjent b'iperkolesterolemija eterozigota familjali severa.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 March 2013.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fil-21 ta' Marzu 2013.
English: On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia.
Maltese: Fit-13 ta' Diċembru 2012, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Kynamro, maħsub għall-kura ta' pazjenti b'ċerti forom ta' iperkolesterolemija familjali.
English: The main measure of effectiveness was the reduction in the patients' LDL cholesterol levels.
Maltese: Il-kejl ewlieni ta' effikaċja kien it-tnaqqis fil-livelli tal-kolesterol LDL tal-pazjenti.
English: This prevented the CHMP from concluding that Kynamro's intended cardiovascular benefit, in terms of reducing cholesterol levels, outweighed its potential cardiovascular risk.
Maltese: Dan ipprevjena lis-CHMP milli jikkonkludi li l-benefiċċju kardjovaskulari maħsub ta' Kynamro, f'termini ta' tnaqqis tal-livelli tal-kolesterol, huwa akbar mirriskju kardjovaskulari potenzjali tiegħu.
English: What was Kynamro expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Kynamro?
English: Kynamro was expected to be used to treat patients with an inherited disease causing high blood cholesterol levels, called familial hypercholesterolaemia.
Maltese: Kynamro kien mistenni li jintuża fil-kura ta' pazjenti b'marda li tintiret li tikkawża livelli għoljin ta' kolesterol fid-demm, imsejħa iperkolesterolemija familjali.
English: By blocking the production of apolipoprotein B, Kynamro was expected to reduce the levels of these types of lipoproteins in the blood of patients.
Maltese: Billi jimblokka l-produzzjoni tal-apolipoproteina B, Kynamro kien mistenni li jnaqqas il-livelli ta' dawn it-tipi ta' lipoproteini fid-demm tal-pazjenti.
English: During the assessment of Kynamro, the indication was restricted to the most severely affected patients with homozygous and compound heterozygous familial hypercholesterolaemia only.
Maltese: Matul l-evalwazzjoni ta' Kynamro, l-indikazzjoni kienet ristretta għall-pazjenti l-aktar milquta b'mod sever b'iperkolesterolemija familjali omozigota u eterozigota komposta biss.
English: In December 2012, the CHMP was concerned that a high proportion of patients stopped taking the medicine within two years, even in the restricted group of patients with homozygous familial hypercholesterolaemia, mainly due to side effects.
Maltese: F'Diċembru 2012, is-CHMP kien imħasseb li fi żmien sentejn kien hemm proporzjon għoli ta' pazjenti li waqfu jieħdu l-mediċina, anki fil-grupp ristrett ta' pazjenti b'iperkolesterolemija omozigota familjali, prinċipalment minħabba effetti sekondarji.
English: It was initially expected to be used to treat two closely related forms of the disease called ‘severe heterozygous' and ‘homozygous' familial hypercholesterolaemia.
Maltese: Fil-bidu kien mistenni li jintuża fil-kura ta' żewġ forom relatati ħafna tal-marda msejħa iperkolesterolemija familjali ‘eterozigota severa' u ‘omozigota'.
English: The effects of Kynamro were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Kynamro ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil-bnedmin.
English: Patients with homozygous familial hypercholesterolaemia have high blood levels of these types of cholesterol, which increases the risk of coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle).
Maltese: Pazjenti b'iperkolesterolemija omozigota familjali għandhom livelli għoljin ta' dawn it-tipi ta' kolesterol fid-demm, li jżid ir-riskju ta' mard koronarju tal-qalb (mard tal-qalb ikkawżat mill-imblukkar tal-vini li jissupplixxu l-muskolu talqalb).
English: Moreover, the Committee was concerned that more cardiovascular events (problems with the heart and blood vessels) were reported in patients taking Kynamro than in patients taking placebo.
Maltese: Barra minn hekk, il-Kumitat kien imħasseb li ġew irrapportati aktar avvenimenti kardjovaskulari (problemi bil-qalb u bil-vini) f'pazjenti li kienu qed jieħdu Kynamro milli f'pazjenti li kienu qed jieħdu plaċebo.