FrancophonIA/ELRC3.0 huggingface dataset:
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Maltese: Sustanzi attivi li jista' jkollhom il-konċentrazzjonijiet fil-plasma alterati minn gefitinib Studji in vitro urew li gefitinib jista' jnaqqas l-attività ta' CYP2D6 b'mod limitat.
English: The frequency of adverse drug reactions relating to abnormal laboratory values is based on patients with a change from baseline of 2 or more CTC grades in the relevant laboratory parameters.
Maltese: Il-frekwenza ta' reazzjonijiet avversi tal-mediċina relatati ma' valuri tal-laboratorju li huma anormali hija bbażata fuq pazjenti b'tibdil minn linja bażi ta' 2 jew aktar fil-grad CTC skont parametri tallaboratorju relevanti.
English: 30x1 film-coated tablets
Maltese: 30×1 pillola miksija b'rita
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Maltese: intervall ta' fiduċja għal HR c Intervall ta' fiduċja kompletament taħt il-marġini ta' non-inferjorità ta' 1.154 N
English: Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Maltese: Wara amministrazzjoni b'mod orali ta' gefitinib immarkat C 14 f'firien li qed ireddgħu, 14-il jum wara l-ħlas, il-konċentrazzjonijiet ta' radjoattività fil-ħalib kienu bejn 11 u 19-il darba ogħla milli fid-demm.
English: Very common Anorexia mild or moderate (CTC grade 1 or 2).
Maltese: Komuni ħafna Anoressija, ħafifa jew moderata (CTC grad 1 jew 2).
English: 28/70 (40%) of never smokers are M+.
Maltese: 28/70 (40%) ta' dawk li qatt ma pejpu huma M+.
English: • Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, your doctor may tell you to stop taking Gefitinib Mylan.
Maltese: • Żieda tal-bilirubin u enzima oħra tal-fwied magħrufa bħala aspartate aminotransferase f'test tad demm; jekk għoli ħafna, it-tabib jista' jgħidlek biex tieqaf tieħu Gefitinib Mylan.
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Maltese: Tabella 6 Riżultati tal-effikaċja għal gefitinib versus plaċebo mill-istudju ISEL Popolazzjoni
English: • Increase of creatinine levels in a blood test (related to kidney function).
Maltese: • Żieda fil-livelli ta' krejatinina f'test tad-demm (relatata mal-funzjoni tal-kliewi).
English: From analyses of population pharmacokinetic data in cancer patients, no relationships were identified between predicted steady-state trough concentration and patient age, body weight, gender, ethnicity or creatinine clearance (above 20 ml/min).
Maltese: Minn analiżi ta' dejta farmakokinetika tal-popolazzjoni ta' pazjenti bil-kanċer, ma kienx hemm l-ebda relazzjoni identifikata bejn il-livell minimu mbassar tal-konċentrazzjoni fi stat fiss u l-età, il-piż, sess, gens u l-eliminazzjoni ta' kreatinina (aktar minn 20 mL/min).
English: Dry mouth*, predominantly mild (CTC grade 1).
Maltese: Ħalq xott*, ta' predominanza ħafifa (CTC grad 1).
English: Gefitinib is a selective small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase and is an effective treatment for patients with tumours with activating mutations of the EGFR tyrosine kinase domain regardless of line of therapy.
Maltese: Gefitinib huwa inibittur selettiv tal-molekuli żgħar tar-reċettur tal-fattur tat-tkabbir epidermali tyrosine kinase u huwa kura effettiva għal pazjenti b'tumuri b'mutazzjonijiet attivanti tad-domain ta' EGFR tyrosine kinase irrispettivament mil-linja ta' terapija.
English: - Rifampicin (for tuberculosis).
Maltese: - Phenytoin jew carbamażepine (għall-epilessija) - Rifampicin (għat-tuberkulożi)
English: Elevations in aspartate aminotransferase, mainly mild to moderate.
Maltese: Żidiet ħfief jew moderati ta' aspartate aminotransferase.
English: PVC/PVDC/Aluminium perforated unit dose blister in cartons containing 30x1 film-coated tablets.
Maltese: Folja tal-PVC/PVDC/Aluminju mtaqqba b'doża waħda f'kartuni li fihom 30×1 pillola miksija b'rita.
English: a Values presented are for gefitinib versus placebo.
Maltese: Il-valuri ppreżentati huma għal gefitinib versus plaċebo.
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia.
Maltese: Deidrazzjoni, li tirriżulta mid-dijarea, dardir, rimettar jew anoressija.
English: Table 3 - Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Maltese: Tabella 3 - Riżultati tal-effikaċja għal gefitinib versus carboplatin/paclitaxel mill-istudju IPASS Popolazzjoni
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Maltese: Prodotti mediċinali li jgħollu b'mod sinifikanti u sostnut il-pH gastriku, bħal inibituri proton-pump u antagonisti ta' h2, jistgħu jnaqqsu l-bijodisponibilità u l-konċentrazzjonijiet fil-plasma ta' gefitinib u b'hekk tista' tonqos l-effikaċja.
English: In vitro data indicate that CYP3A4 and CYP2D6 are the major P450 isozyme involved in the oxidative metabolism of gefitinib.
Maltese: Tagħrif in vitro jindika li CYP3A4 u CYP2D6 huma l-aktar isoenzimi P450 li għandhom x'jaqsmu mal-metaboliżmu li jossida l-gefitinib.
English: HR 1.020 [0.905, 1.150]c 7.6 m vs 8.0 m p=0.7332
Maltese: HR 1.020 7.6 m vs 8.0 m p=0.7332
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1).
Maltese: Konġuntivite, blefarite, u għajnejn xotti*, l-aktar ħfief (CTC grad 1).
English: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Maltese: Ir-riskju ta' mortalità fost pazjenti li żviluppaw ILD waqr li kienu fuq gefitinib jew kimoterapija kien ogħla f'pazjenti b'dawn il-fatturi ta' riskju li ġejjin: tipjip, evidenza b'CT scan ta' tiċkin ta' pulmun normali (<50%), ILD pre-eżistenti, età akbar (≥65 sena), u żoni estensivi aderenti mal-plewra (≥50%).
English: Stomatitis, predominantly mild in nature (CTC grade 1).
Maltese: Stomatite ta' predominanza ħafifa (CTC grad 1).
English: • The recommended dose is one 250 mg tablet per day.
Maltese: • Id-doża rakkomandata hija pillola ta' 250 mg kuljum.
English: At steady state, circulating plasma concentrations are typically maintained within a 2- to 3-fold range over the 24-hour dosing interval.
Maltese: Fi stat fiss, konċentrazzjonijiet li jiċċirkulaw fil-plasma jinżammu fil-medda ta' bejn 2 u 3 darbiet aktar fuq intervall ta'dożaġġ ta' 24 siegħa.
English: Elevations in total bilirubin, mainly mild to moderate.
Maltese: Żidiet ħfief jew moderati ta' bilirubin totali.
English: Asiansd
Maltese: Asjatiċic
English: The signs may include redness, pain, ulcers, blisters, and shedding of the skin.
Maltese: Is-sinjali jistgħu jinkludu ħmura, uġigħ, ulċeri, infafet, u tqaxxir ta' ġilda.
English: Odds of EGFR mutation
Maltese: Mutazzjoni pożittiva ta' EGFR
English: Brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.
Maltese: Pilloli miksija b'rita kannella, tondi, ibbuzzati fuq iż-żewġ naħat b'daqs ta' madwar 11.1 mm x 5.6 mm u mmarkati b'“250” fuq naħa waħda u xejn fuq in-naħa l-oħra.
English: Only limited data are available in patients with creatinine clearance ≤ 20 ml/min and caution is advised in these patients (see section 5.2).
Maltese: Dejta limitata biss hija disponibbli f'pazjenti bi tneħħija tal-krejatinina ta' ≤20 mL/min, u f'dawn il-pazjenti hija rrakkomandata l-kawtela (ara sezzjoni 5.2).
English: • Vomiting.
Maltese: • Rimettar.
English: Table 2 - Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Maltese: Tabella 2 - Sommarju tal-istatus ta' mutazzjoni tal-linja bażi għall-kampjuni ta' tumuri u ctDNA fil-pazjenti skrinjati kollha evalwabbli għaż-żewġ kampjuni
English: The majority of ILD-type events reported was from patients of Asian ethnicity and the ILD incidence among patients of Asian ethnicity receiving gefitinib therapy and placebo was approximately 3% and 4% respectively.
Maltese: Il-maġġoranza ta' avvenimenti ta' tip ILD rrapportati kienu minn pazjenti ta' oriġini Asjatika u l-inċidenza ta' ILD f'pazjenti ta' oriġini Asjatika li rċevew kura b'gefitinib u plaċebo kienu bejn wieħed u ieħor ta' 3% u 4% rispettivament.
English: Table 1 Adverse reactions
Maltese: Tabella 1 - Reazzjonijiet avversi
English: No dose adjustment is required in patients with impaired renal function at creatinine clearance > 20 ml/min.
Maltese: Ma hemmx bżonn ta' tibdil fid-doża f'pazjenti b'indeboliment fil-funzjoni renali, bi tneħħija talkrejatinina ta' >20 mL/min.
English: BATCH NUMBER
Maltese: Mhux Asjatiċi
English: LCS symptom improvement ratea
Maltese: GĦAMLA KWALITATTIVA
English: The safety profile presented in Table 1 is based on the gefitinib clinical development programme and post-marketed experience.
Maltese: Il-profil tas-sigurtà ppreżentat f'Tabella 1 huwa bbażat fuq programm ta' żvilupp kliniku u esperjenza ta' wara t-tqegħid fis-suq b'gefitinib.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib.
Maltese: Pazjenti b'indeboliment epatiku moderat għal sever (Child Pugh B jew C) minħabba ċirrożi jkollhom żieda fil-konċentrazzjoni ta' gefitinib fil-plasma.
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitizing EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Maltese: L-istudju IFUM kien studju b'aktar minn ċentru wieħed, b'fergħa waħda li sar fost pazjenti Kawkażi (n=106) b'NSCLC b'mutazzjoni pożittiva tal-EGFR attivanti, sensitizzanti, biex jikkonferma li lattività ta' gefitinib hija simili f'popolazzjonijiet Kawkażi u Asjatiċi.
English: Do not take Gefitinib Mylan: - if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Gefitinib Mylan: - jekk inti allerġiku għal gefitinib jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6). - jekk qed tredda'.
English: Nausea, mainly mild (CTC grade 1).
Maltese: Dardir, l-aktar ħafif (CTC grad 1).
English: 4.4 times higher in adenocarcinoma than in non-adenocarcinoma
Maltese: 4.4 drabi ogħla f'adenokarċinoma milli f'nonadenokarċinoma
English: Cutaneous vasculitis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
Maltese: Meta amministrat fil-far tul il-ġestazzjoni u t-twelid kien hemm tnaqqis fissopravivenza tal-friegħ f'doża ta' 20 mg/kg/jum.
English: Mechanism of action and pharmacodynamic effects The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Maltese: Il-fattur għat-tiġdid epidermiku (EGF) u r-riċettur tiegħu (EGFR[HER1; ErbB1]) kienu identifikati bħala l-fatturi prinċipali fil-proċess ta' tkabbir u proliferazzjoni ta' ċelloli normali u dawk tal-kanċer.
English: - Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Maltese: - Warfarina (sustanza orali kontra l-koagulazzjoni tad-demm, li ma tħallix id-demm jagħqad).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of gefitinib.
Maltese: Madankollu, fil-fenek kien hemm tnaqqis fil-piż fetali b'20 mg/kg/jum u aktar.
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Maltese: John's Wort/Hypericum perforatum) jistgħu jnaqqsu mill-effikaċja tal-kura u għandhom jiġu evitati (ara sezzjoni 4.5).
English: Haemorrhagic cystitis
Maltese: OĦRA, JEKK MEĦTIEĠA
English: In that study, sensitivity was 43.1%, specificity was 100%.
Maltese: F'dak l-istudju, is-sensittività kienet ta' 43.1 %, l-ispeċifiċità kienet ta' 100 %.
English: Gefitinib has a mean steady-state volume of distribution of 1400 L indicating extensive distribution into tissue.
Maltese: Gefitinib għandu volum medju ta' kif jitqassam fi stat stabbli ta' 1400 L li jindika tqassim estensiv fittessuti.
English: The effects reached statistical significance for the female mice, but not for the males.
Maltese: L-effetti laħqu sinifikat statistiku fil-ġrieden nisa, iżda mhux għall-irġiel.
English: During treatment with gefitinib, asthenia has been reported.
Maltese: Emorraġija, bħal epistassi u ematurja.
English: PC:
Maltese: LCS
English: Very common Diarrhoea, mainly mild or moderate (CTC grade 1 or 2).
Maltese: Komuni ħafna Dijarea, l-aktar ħafifa jew moderata (CTC grad 1 jew 2).
English: Survival outcomes differed by smoking status and ethnicity (see Table 6).
Maltese: Ir-riżultat ta' sopravivenza varja skont l-istat ta' tipjip u l-etniċità (ara Tabella 6).
English: Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy (see section 4.3).
Maltese: Gefitinib u l-metaboliti tiegħu akkumulaw fil-ħalib ta' firien li qed ireddgħu (ara sezzjoni 5.3). Gefitinib hu kontra-indikat waqt it-treddigħ u għalhekk it-treddigħ għandu jitwaqqaf waqt li qed jirċievu l-kura b'gefitinib (ara sezzjoni 4.3).
English: Without crushing it, the tablet should be dropped in half a glass of drinking water.
Maltese: Mingħajr ma tiġi mfarrka, il-pillola għandha tintreħa f'nofs tazza ilma tax-xorb.
English: CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
Maltese: Sustanzi li jżidu l-attività ta' CYP3A4 jistgħu jżidu l-metaboliżmu ta' gefitinib u jnaqqsu lkonċentrazzjoni ta' gefitinib fil-plasma.
English: Asymptomatic laboratory elevations in blood creatinine.
Maltese: Żieda fil-livelli tal-laboratorju ta' kreatina fid-demm mingħajr sintomi.
English: This may mean that you have an inflammation of the lungs called ‘interstitial lung disease'.
Maltese: Mard interstizjali tal-pulmun (Interstitial lung disease - ILD)
English: In vitro data indicate that gefitinib is a substrate for the membrane transport protein P-gp.
Maltese: Tagħrif in vitro jindika li gefitinib huwa substrat għal proteina tat-trasport fil-membrana P gp.
English: Both ctDNA and tumour samples were evaluable for 652 patients out of 1060 screened.
Maltese: Kemm il-kampjuni tas-ctDNA kif ukoll dawk tat-tumur kienu evalwabbli għal 652 pazjent minn 1060 eżaminati.
English: Gastrointestinal perforation has been reported in patients taking gefitinib.
Maltese: Perforazzjoni gastrointestinali ġiet irrappurtata f'pazjenti li kienu qed jieħdu gefitinib.
English: • Nausea.
Maltese: • Deni.
English: In most cases this is associated with other known risk factors, including concomitant medicinal products such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Maltese: F'ħafna każijiet din hija assoċjata ma' fatturi oħrajn magħrufa ta' riskju, li jinkludu teħid flimkien ma' prodotti mediċinali oħra bħal sterojdi jew NSAIDS, storja preċedenti ta' ulċerazzjoni tal-GI, età, tipjip jew metastasi tal-imsaren fil-postijiet ta' perforazzjoni.
English: Renal and urinary disorders Common
Maltese: Disturbi fil-kliewi u fissistema urinarja
English: When considering the use of Gefitinib Mylan as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients.
Maltese: Meta jitqies l-użu ta' Gefitinib Mylan bħala kura għal NSCLC lokalment avvanzat jew metastatiku, huwa importanti li jsir tentattiv sabiex tingħata valutazzjoni tal-mutazzjoni ta' EGFR tat-tessut tattumur għall-pazjenti kollha.
English: Table 7 - Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients* Factors that predicted for presence of EGFR mutation p-value
Maltese: Tabella 7 - Sommarju tal-analiżi ta' rigressjoni loġistika multivarjanti sabiex tidentifika fatturi li indipendentament ibassru l-preżenza ta' mutazzjonijiet tal-EGFR f'786 pazjent Kawkasu* Fatturi li jbassru lpreżenza ta' mutazzjonijiet tal-EGFR
English: There is no relevant use of gefitinib in the paediatric population in the indication of NSCLC.
Maltese: Ma hemmx użu relevanti ta' gefitinib fil-popolazzjoni pedjatrika flindikazzjoni ta' NSCLC.
English: The randomised phase III first line IPASS study was conducted in patients in Asia1 with advanced (stage IIIB or IV) NSCLC of adenocarcinoma histology who were ex-light smokers (ceased smoking ≥ 15 years ago and smoked ≤ 10 pack years) or never smokers (see Table 3).
Maltese: III, fejn il-pazjenti ntgħażlu b'mod arbitrarju, sar f'pazjenti flAsja1 li kellhom NSCLC ta' istoloġija ta' adenokarċinoma avvanzat (stadju IIIB jew IV), li kienu jpejpu xi ftit (waqfu jpejpu >15-il sena ilu u pejpu <10 snin pakkett) jew li qatt ma pejpu (ara Tabella 3).
English: NR Not reached.
Maltese: NR Mhux milħuq.
English: If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, Gefitinib Mylan should be interrupted and the patient should be promptly investigated.
Maltese: Jekk il-pazjenti jesperjenzaw aggravar tas-sintomi respiratorji bħal qtugħ ta' nifs, sogħla u deni, Gefitinib Mylan għandu jitwaqqaf u l-pazjent għandu jiġi investigat fil-pront.
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Maltese: Żieda fl-INR u/jew xi episodju ta' telf ta'demm ġew irapportati f'xi pazjenti li jieħdu l-warfarina (ara sezzjoni 4.4).
English: The safety and efficacy of Gefitinib Mylan in children and adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Gefitinib Mylan fit-tfal u l-adolexxenti ta' anqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 May 2015
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20
English: It was to be available as 300 mg tablets.
Maltese: Dan kellu jkun disponibbli bħala pilloli ta' 300 mg.
English: Corluxin is a medicine containing the active substance mifepristone.
Maltese: Corluxin huwa mediċina li fiha s-sustanza attiva mifepristone.
English: What is Corluxin?
Maltese: X'inhu Corluxin?
English: On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Maltese: Fit-23 ta' Marzu 2015, FGK Representative Service GmbH għarraf uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għallawtorizzazzjoni għat-tqegħid fis-suq għal Corluxin, maħsub għall-kura tas-sindrome ta' Cushing.
English: The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Maltese: Is-sustanza attiva f'Corluxin, il-mifepristone, hija magħrufa li timblokka r-riċetturi għall-kortiżol magħrufa bħala r-riċetturi tal-glukokortikojdi (GR-II).
English: Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Maltese: Il-pazjenti bis-sindrome ta' Cushing jista' jkollhom żieda fil-piż ‘ċentrali' (li taffettwa l-wiċċ u t-torso iżda mhux id-dirgħajn u r-riġlejn), tkabbir ta' xaħam fuq l-għadma tal-għonq u l-wara tal-għonq, wiċċ ġej fit-tond, tbenġil malajr, tkabbir eċċessiv ta' xagħar aħrax fuq il-wiċċ, dgħufija tal-muskoli u l-għadam, depressjoni, dijabete u pressjoni għolja tad-demm.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Corluxin (mifepristone)
English: On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Maltese: B'mod ġenerali, l-evidenza għall-effikaċja fl-indikazzjoni li għaliha saret l-applikazzjoni kienet limitata u kien hemm xi tħassib dwar is-sigurtà bil-mediċina, inklużi l-effetti sekondarji kkawżati mill-attività mnaqqsa tal-kortiżol fiċ-ċirkolazzjoni, id-disturbi fil-fluwidi u l-minerali (b'mod partikolari t-tnaqqis fillivelli tal-potassju fid-demm u ż-żieda fil-pressjoni tad-demm f'xi pazjenti) u t-tħaxxin tal-ġuf f'xi pazjenti nisa.
English: The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition.
Maltese: L-applikant issottometta dejta minn studju prinċipali li kien jinvolvi 50 pazjent bis-sindrome ta' Cushing li kellhom id-dijabete u/jew pressjoni għolja tad-demm, żewġ karatteristiċi komuni tal-kundizzjoni.
English: What was Corluxin expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Corluxin?
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Maltese: Is-sindrome ta' Cushing huwa marda kkaratterizzata minn produzzjoni żejda tal-ormon kortiżol millglandoli adrenali, żewġ glandoli li jinsabu fuq il-kliewi.
English: The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
Maltese: Is-CHMP kellu tħassib relatat mal-manifattura tal-mediċina, inkluż il-kontroll tal-impuritajiet u littestjar tal-prodott lest.
English: At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
Maltese: Fiż-żmien tal-irtirar, is-CHMP kien tal-idea provviżorja li Corluxin ma setax jiġi approvat għall-użu flindikazzjoni wiesgħa li l-kumpanija applikat għaliha, li kienet il-“kura ta' pazjenti adulti bis-sindrome endoġenu ta' Cushing li għalihom il-kirurġija ma kinitx opzjoni jew li fuqhom il-kirurġija ma rnexxietx.
English: Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Maltese: Corluxin kellu jintuża għall-kura tas-sindrome ta' Cushing f'pazjenti li ma tistax issirilhom kirurġija jew li fuqhom il-kirurġija ma rnexxietx.
English: The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
Maltese: Il-MAHs għandhom jinfurmaw lill-professjonisti tal-kura tas-saħħa rigward l-eżitu ta' din ir-reviżjoni dwar nimesulide permezz ta' “Komunikazzjoni Diretta mal-Professjonisti tal-Kura tas-Saħħa” (DHPC) kif miftiehem mis-CHMP.
English: The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Maltese: Id-data armonizzata għar-rilaxx tal-ittra hija ta' 15-il jum ta' xogħol wara d-deċiżjoni tal-Kummissjoni Ewropea.