FrancophonIA/ELRC3.0 huggingface dataset:
English: Following prenatal exposure, increased incidences of post-implantation loss and reduced foetal weights were observed in rats and ribociclib was teratogenic in rabbits at exposures lower than or 1.5 times the exposure in humans, respectively, at the highest recommended dose of 600 mg/day based on AUC.
Maltese: Wara esponiment ta' qabel it-twelid, żieda fl-inċidenzi ta' telf ta' wara limpjantazzjoni u tnaqqis fil-piż tal-fetu kienu osservati fil-firien u ribociclib kien teratoġeniku fil-fniek f'esponimenti ta' inqas minn jew 1.5 darbiet l-esponiment fil-bnedmin, rispettivament, fl-ogħla doża rakkomandata ta' 600 mg/jum ibbażata fuq l-AUC.
English: In vivo studies using patient-derived oestrogen receptor-positive breast cancer xenograft model combinations of ribociclib and antioestrogens (i.e. letrozole) resulted in superior tumour growth inhibition with sustained tumour regression and delayed tumour regrowth after stopping dosing compared to each substance alone.
Maltese: Studji in vivo bl-użu ta' mudell ta' xenograft ta' kanċer tas-sider pożittiv għar-riċettur tal-estroġeni derivat mill-pazjent kombinazzjonijiet ta' ribociclib u sustanzi kontra l-estroġeni (jiġifieri letrozole) wasslu għal inibizzjoni superjuri tat-tkabbir tat-tumur b'rigressjoni sostnuta tat-tumur u ttardjar ta' tkabbir mill-ġdid tat-tumur wara twaqqif tad-dożaġġ meta mqabbel ma' kull sustanza waħedha.
English: In the Kisqali arm 43.7% of patients had received chemotherapy in the neoadjuvant or adjuvant setting and 52.4% had received antihormonal therapy in the neoadjuvant or adjuvant setting prior to study entry.
Maltese: Fil-grupp ta' Kisqali 43.7% tal-pazjenti kienu rċevew kimoterapija f'ambjent neoawżiljarju jew awżiljarju u 52.4% kienu rċevew terapija kontra l-ormoni f'ambjent neoawżiljarju jew awżiljarju qabel id-dħul fl-istudju.
English: • Mouth sores with gum inflammation (stomatitis)
Maltese: • Uġigħ fil-griżmejn (uġigħ orofarinġeali)
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a genotoxic potential of ribociclib.
Maltese: Studji dwar l-effett tossiku fuq il-ġeni f'sistemi batteriċi in vitro u f'sistemi mammiferi in vitro u in vivo bi u mingħajr attivazzjoni metabolika ma żvelat l-ebda evidenza ta' potenzjal ta' effett tossiku ta' ribociclib fuq il-ġeni.
English: Febrile neutropenia was reported in about 1.4% of patients exposed to Kisqali in the phase III studies.
Maltese: Newtropenija bid-deni kienet irrappurtata f'madwar 1.4% tal-pazjenti esposti għal Kisqali fl-istudji ta' fażi
English: - Keep this leaflet.
Maltese: Żminijiet ta' ċensura
English: The dose of a sensitive CYP3A4 substrate with a narrow therapeutic index, including but not limited to alfentanil, ciclosporin, everolimus, fentanyl, sirolimus and tacrolimus, may need to be reduced as ribociclib can increase their exposure.
Maltese: Id-doża ta' sottostrat sensittiv ta' CYP3A4 b'indiċi terapewtiku dejjaq, inkluż iżda mhux limitat għal alfentanil, ciclosporin, everolimus, fentanyl, sirolimus u tacrolimus, jista' jkollha bżonn li tiġi mnaqqsa peress li ribociclib jista' jżid l-esponiment tagħhom.
English: The patients included were Caucasian (85.3%), Asian (8.7%) or Black (0.7%) and nearly all patients (99.7%) had an ECOG performance status of 0 or 1.
Maltese: 3%), Asjatiċi (8.7%) jew Suwed (0.7%) u kważi l-pazjenti kollha (99.7%) kellhom status ta' prestazzjoni ECOG ta' 0 jew 1.
English: A starting dose of 400 mg is recommended in patients with severe renal impairment (see section 5.2).
Maltese: Doża tal-bidu ta' 400 mg hija rakkomandata f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: In non-cancer subjects with severe renal impairment AUCinf increased 1.96-fold, and Cmax increased 1.51-fold compared to healthy subjects with normal renal function (see section 4.2).
Maltese: F'suġġetti mingħajr kanċer b'indeboliment sever tal-kliewi l-AUCinf żdied b'1.96 drabi, u s-Cmax żdied b'1.51 drabi mqabbel ma' suġġetti b'saħħithom b'funzjoni normali tal-kliewi (ara sezzjoni 4.2).
English: Common (may affect up to 1 in 10 people).
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10 persuni).
English: Substances that may have plasma concentrations altered by Kisqali
Maltese: Tabella 1 Linji gwida rakkomandati għal modifikazzjonijiet fid-doża Kisqali
English: Physiologically-based pharmacokinetic simulations suggested that a moderate CYP3A4 inducer (efavirenz) may decrease steady-state ribociclib Cmax and AUC by 51% and 70%, respectively.
Maltese: (efavirenz) jista' jnaqqas Cmax u l-AUC ta' ribociclib fi stat fiss b'51% u 70%, rispettivament.
English: • If you have or have had heart disorders or heart rhythm disorders, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT interval prolongation) or low levels of potassium, magnesium, calcium or phosphorus in your blood.
Maltese: • Jekk għandek jew kellek disturbi fil-qalb jew disturbi fir-ritmu tal-qalb, bħal taħbit tal-qalb irregolari, inkluża kondizzjoni li tissejjaħ sindrome ta' QT twil (intervall ta' QT twil) jew livelli baxxi ta' potassium, magnesium, calcium jew phosphorus fid-demm tiegħek.
English: 63 film-coated tablets (in PA/alu/PVC blisters)
Maltese: 63 pillola miksija b'rita (f'folji PA/alu/PVC)
English: 63 film-coated tablets (in PCTFE/PVC blisters)
Maltese: 63 pillola miksija b'rita (f'folji PCTFE/PVC)
English: Updated results for overall response and clinical benefit rates are displayed in Table 8.
Maltese: Riżultati aġġornati għar-rispons globali u r-rati ta' benefiċċju kliniku huma murija fit-Tabella 8.
English: Abnormal liver function tests: ALT increased, AST increased, blood bilirubin increased.
Maltese: Testijiet tal-funzjoni tal-fwied mhux normali: żieda ta' ALT, żieda ta' AST, żieda ta' bilirubina fid-demm.
English: Overall survival, overall study population
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: • Headache
Maltese: • Stitikezza
English: The study met the primary endpoint at the primary analysis conducted after 318 progression-free survival (PFS) events based on the investigator assessment using RECIST v1.1 criteria in the full analysis set (all randomised patients).
Maltese: L-istudju laħaq il-punt finali primarju fl-analiżi primarja mwettqa wara 318-il avveniment ta' sopravivenza mingħajr progressjoni (PFS) ibbażati fuq il-valutazzjoni tal-investigatur permezz talkriterji ta' RECIST v1.1 fis-sett tal-analiżi sħiħa (il-pazjenti randomizzati kollha).
English: In vivo, treatment with single-agent ribociclib led to tumour regressions which correlated with inhibition of pRb phosphorylation.
Maltese: In vivo, ittrattament b'ribociclib bħala sustanza waħedha wassal għal rigressjonijiet tat-tumur li jikkorrelataw ma' inibizzjoni ta' fosforilazzjoni ta' pRb.
English: • Medicines like intravenous ondansetron, used to prevent nausea and vomiting caused by chemotherapy (treatment with cancer medicines).
Maltese: • Medicines bħal ondansetron fil-vini, użati biex jipprevjenu dardir u rimettar ikkawżati mill kimoterapija (trattament b'mediċini kontra l-kanċer).
English: The film-coated tablets are light greyish violet in colour, unscored, round, debossed with “RIC” on one side and “NVR” on the other side.
Maltese: Il-pilloli miksija b'rita huma ta' lewn vjola ċari fil-griż, mingħajr sinjal imnaqqax, tondi, imnaqqxa b'“RIC” fuq naħa u “NVR” fuq in-naħa l-oħra.
English: Ribociclib has not been studied in breast cancer patients with moderate or severe hepatic impairment.
Maltese: Ribociclib ma ġiex studjat f'pazjenti b'kanċer tas-sider b'indeboliment moderat jew sever tal-fwied.
English: The concomitant use of moderate CYP3A4 inducers may therefore lead to decreased exposure and consequently a risk for impaired efficacy, in particular in patients treated with ribociclib at 400 mg or 200 mg once daily.
Maltese: L-użu flimkien ta' indutturi moderati ta' CYP3A4 jista' għaldaqstant iwassal għal tnaqqis fl-espożizzjoni u konsegwentament għal riskju li jkun hemm effikaċja mdgħajfa, b'mod partikulari f'pazjenti ttrattati b'400 mg jew 200 mg ribociclib darba kuljum.
English: In a fertility study in female rats, ribociclib did not affect reproductive function, fertility or early embryonic development at any dose up to 300 mg/kg/day (which is likely at an exposure lower than or equal to patients' clinical exposure at the highest recommended dose of 600 mg/day based on AUC).
Maltese: Fi studju dwar il-fertilità f'firien nisa, ribociclib ma affettwax il-funzjoni riproduttiva, il-fertilità jew liżvilupp embrijoniku bikri fi kwalunkwe doża sa 300 mg/kg/jum (li x'aktarx tkun f'esponiment aktar baxx minn jew ugwali għall-esponiment kliniku tal-pazjenti fl-ogħla doża rakkomandata ta' 600 mg/jum ibbażata fuq l-AUC).
English: Hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu (95%
English: In study E2301 (MONALEESA-7), a QTcF interval increase >60 msec from baseline was observed in 14/87 (16.1%) patients receiving Kisqali plus tamoxifen and in 18/245 (7.3%) patients receiving Kisqali plus a non-steroidal aromatase inhibitor (NSAI).
Maltese: Fl-istudju E2301 (MONALEESA-7), ġiet osservata żieda fl-intervall QTcF >60 msec mil-linja bażi f'14/87 (16.
English: 200 mg*/day * If further dose reduction below 200 mg/day is required, the treatment should be permanently discontinued.
Maltese: 200 mg*/jum * Jekk ikun meħtieġ aktar tnaqqis fid-doża taħt 200 mg/jum, it-trattament għandu titwaqqaf għal kollox.
English: Physiologically-based pharmacokinetic simulations suggested that at a 600 mg dose of ribociclib, a moderate CYP3A4 inhibitor (erythromycin) may increase ribociclib steady-state Cmax and AUC 1.2-fold and 1.3-fold, respectively.
Maltese: Simulazzjonijiet farmakokinetiċi abbażi fiżjoloġika ssuġġerew li doża ta' 600 mg ribociclib, inibitur moderat ta' CYP3A4
English: Drug-drug interaction between ribociclib and fulvestrant
Maltese: Interazzjoni bejn mediċina u oħra bejn ribociclib u fulvestrant
English: Hepatobiliary disorders Hepatotoxicity
Maltese: Reazzjoni avversa tal-mediċina
English: • Medicines used to treat angina such as bepridil.
Maltese: • Mediċini użati biex jittrattaw l-anġina bħal bepridil.
English: No overall differences in safety or effectiveness of Kisqali were observed between these patients and younger patients (see section 4.2).
Maltese: L-ebda differenza ġenerali fis-sigurtà jew l-effettività ta' Kisqali ma ġiet osservata bejn dawn il-pazjenti u pazjenti iżgħar (ara sezzjoni 4.2).
English: Serial, triplicate ECGs were collected following a single dose and at steady state to evaluate the effect of ribociclib on the QTc interval in patients with advanced cancer.
Maltese: Riżultati ta' ECGs ripetuti għal tliet darbiet wara xulxin inġabru wara doża waħda u fi stat fiss biex jiġi evalwat l-effett ta' ribociclib fuq l-intervall QTc f'pazjenti b'kanċer avanzat.
English: • Upset stomach, indigestion, heartburn (dyspepsia)
Maltese: • Qtugħ ta' nifs, diffikultà biex tieħu n-nifs
English: The median duration of exposure to Kisqali treatment across the pooled phase III studies dataset was 16.5 months, with 61.7% patients exposed ≥12 months.
Maltese: III kien ta' 16.5 xhur, b'61.7% tal-pazjenti esposti ≥12-il xahar.
English: Co-administration of the strong CYP3A4 inhibitor ritonavir (100 mg twice daily for 14 days) with a single 400 mg dose of ribociclib increased ribociclib exposure (AUCinf) and the peak concentration (Cmax) in healthy subjects 3.2 and 1.7-fold, respectively, relative to a single 400 mg ribociclib dose given alone.
Maltese: Lgħoti tal-inibitur qawwi ta' CYP3A4 ritonavir (100 mg darbtejn kuljum għal 14-il jġurnata) flimkien ma' doża waħda ta' 400 mg ta' ribociclib żied l-esponiment għal ribociclib (AUCinf) u lkonċentrazzjoni massima (Cmax - peak concentration) f'individwi f'saħħithom bi 3.2 u 1.7 darbiet, rispettivament, meta mqabbel ma' doża waħda ta' 400 mg ribociclib mogħtija waħedha. Cmax u AUClast għal LEQ803 (metabolit prominenti ta' ribociclib responsabbli għal anqas minn 10% tal-esponiment tas-sustanza oriġinali) naqsu b'96% u 98%, rispettivament.
English: It is very important to follow your doctor's instructions.
Maltese: Huwa importanti ħafna li ssegwi l-istruzzjonijiet tat-tabib tiegħek.
English: Grade 1 or 2**
Maltese: Tossiċitajiet oħra Grad 1 jew 2**
English: In 6 healthy male subjects, following a single oral dose of [
Maltese: F'6 individwi rġiel f'saħħithom, wara doża orali waħda ta' [
English: The median follow-up time at the time of primary PFS analysis was 19.2 months.
Maltese: Iż-żmien ta' segwitu medjan fiż-żmien tal-analiżi primarja tal-PFS kien ta' 19.2 xhur.
English: Uncommon (may affect up to 1 in 100 people).
Maltese: Mhux komuni (tista' taffettwa sa persuna waħda minn kull 100 persuna).
English: Ribociclib showed foetotoxicity and teratogenicity at doses which did not show maternal toxicity in the rats or rabbits.
Maltese: Ribociclib wera effett tossiku fuq il-fetu u teratoġeniċità b'dożi li ma wrewx effett tossiku fl-omm filfirien u l-fniek.
English: Kisqali can be administered with or without food (see sections 4.2 and 5.2).
Maltese: Kisqali jista' jingħata mal-ikel jew mingħajr ikel (ara sezzjonijiet 4.2 u 5.2).
English: After initiating treatment CBC should be monitored every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, then as clinically indicated.
Maltese: Wara li jinbeda t-trattament b'Kisqali CBC għandu jiġi mmonitorjat kull ġimagħtejn għall-ewwel 2 ċikli, filbidu ta' kull wieħed mill-4 ċikli sussegwenti, imbagħad kif indikat klinikament.
English: In case of QTcF prolongation during treatment, more frequent ECG monitoring is recommended.
Maltese: Fil-każ ta' titwil ta' QTcF waqt it-trattament, huwa rakkomandat monitoraġġ aktar frekwenti tal-ECG.
English: If QTcF is greater than 500 msec, interrupt Kisqali until QTcF is <481 msec then resume Kisqali at next lower dose level.
Maltese: 3. Jekk jerġa' jseħħ QTcF ta' ≥481 msec, interrompi d-doża sakemm QTcF jirkupra għal <481 msec u mbagħad ibda Kisqali mill-ġdid f'livell ta' doża inqas.
English: Kisqali was evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of pre- and perimenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer in combination with a NSAI or tamoxifen plus goserelin versus placebo in combination with a NSAI or tamoxifen plus goserelin.
Maltese: III fit-trattament ta' nisa qabel u waqt il-menopawsa b'kanċer tas-sider avvanzat, pożittiv għar-riċettur tal-ormoni, negattiv għall-HER2 flimkien ma' NSAI jew tamoxifen flimkien ma' goserelin meta mqabbel ma' plaċebo flimkien ma' NSAI jew tamoxifen flimkien ma' goserelin.
English: Ribociclib is not a substrate for hepatic uptake transporters OATP1B1, OATP1B3 or OCT-1 in vitro.
Maltese: Ribociclib mhuwiex sottostrat għat-teħid tat-trasportaturi epatiċi OATP1B1, OATP1B3 jew OCT-1 in vitro.
English: Based on animal studies, ribociclib may impair fertility in males of reproductive potential (see section 5.3).
Maltese: Abbażi tal-istudji fuq l-annimali, ribociclib jista' jnaqqas il-fertilità fl-irġiel b'potenzjal riproduttiv (ara sezzjoni 5.3).
English: Number of patients still at risk
Maltese: Numru ta' pazjenti li għadhom f'riskju
English: AST and/or ALT elevations from baseline**, without increase in total bilirubin above 2 x ULN
Maltese: Żidiet ta' AST u/jew ALT millinja bażi**, mingħajr żieda fil-bilirubina totali 'l fuq minn 2 x ULN
English: • Methadone, used to treat pain or addiction to opioids.
Maltese: • Methadone, użat biex jittratta uġigħ jew dipendenza fuq l-opioids.
English: Kisqali may increase or decrease your blood levels of some other medicines.
Maltese: Kisqali jista' jżid jew inaqqas il-livelli fid-demm tiegħek ta' xi mediċini oħra.
English: A reduction in the risk of disease progression or death in favour of the Kisqali plus letrozole arm was observed in all individual patient subgroups of age, race, prior adjuvant or neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement and bone-only metastatic disease.
Maltese: Kien osservat tnaqqis fir-riskju ta' progressjoni tal-marda jew mewt favur il-grupp ta' Kisqali flimkien ma' letrozole fis-sottogruppi individwali tal-pazjenti kollha ta' età, razza, terapiji awżiljarji jew neoawżiljarja permezz ta' kimoterapija jew ormonali minn qabel, involviment tal-fwied u/jew tal-pulmun u marda metastatika fl-għadam biss.
English: In vitro and in vivo studies indicated ribociclib is eliminated primarily via hepatic metabolism mainly via CYP3A4 in humans.
Maltese: Studji in vitro u in vivo indikaw li ribociclib jiġi eleminat primarjament permezz tal-metaboliżmu epatiku prinċipalment permezz ta' CYP3A4 fil-bnedmin.
English: The effect of a moderate CYP3A4 inducer on ribociclib exposure has not been studied.
Maltese: L-effett ta' induttur moderat ta' CYP3A4 fuq l-espożizzjoni ta' ribociclib ma ġiex studjat.
English: Placebo plus NSAI plus goserelin N=247
Maltese: Plaċebo flimkien ma' NSAI flimkien ma' goserelin N=247
English: ECG should be assessed before initiating treatment with Kisqali.
Maltese: ECG għandu jiġi evalwat qabel ma jinbeda t-trattament b'Kisqali.
English: • Serious infection with increased heart rate, shortness of breath or rapid breathing, fever and chills (these may be signs of sepsis which is an infection in the blood system which may be life threatening).
Maltese: • Infezzjoni serja b'żieda fir-rata tat-taħbit tal-qalb, qtugħ ta' nifs jew nifs mgħaġġel, deni u tkexkix ta' bard (dawn jistgħu jkunu sinjali ta' sepsis li hija infezzjoni fis-sistema tad-demm li tista' tkun ta' periklu għall-ħajja).
English: The global health status/QoL data showed no relevant difference between the Kisqali plus letrozole arm and the placebo plus letrozole arm.
Maltese: Id-data dwar l-istat tas-saħħa globali/ QoL ma wriet l-ebda differenza rilevanti bejn il-grupp ta' Kisqali flimkien ma' letrozole u l-grupp tal-plaċebo flimkien ma' letrozole.
English: Neutropenia
Maltese: Manifattur
English: Updated analysis (02 January 2017 cut-off) Kisqali plus letrozole
Maltese: Analiżi aġġornata (data meta waqfet tinġabar id-data 02 ta' Jannar 2017)
English: Cardiac disorders Syncope
Maltese: Disturbi gastro-intestinali
English: Your doctor may also decide to stop treatment with Kisqali permanently.
Maltese: It-tabib tiegħek jista' jiddeċiedi wkoll li jwaqqaf it-trattament b'Kisqali b'mod permanenti.
English: CBR: Clinical benefit rate = proportion of patients with complete response + partial response (+ stable disease or non-complete response/Non-progressive disease ≥24 weeks)
Maltese: CBR: Rata ta' benefiċċju kliniku = proporzjon ta' pazjenti b'rispons sħiħ + rispons parzjali (+ marda stabbli jew rispons mhux sħiħ/Marda mhux progressiva għal ≥24 ġimgħa)
English: • Chest pain or discomfort, changes in heart beat (fast or slow), palpitations, lightheadedness, fainting, dizziness, lips turning blue colour, shortness of breath, swelling (oedema) of your lower limbs or skin (these may be signs of heart problems).
Maltese: • Uġigħ jew skumdità fis-sider, tibdil fit-taħbit tal-qalb (mgħaġġel jew bil-mod), palpitazzjonijiet, mejt, ħass ħażin, sturdament, lewn blu fix-xufftejn, qtugħ ta' nifs, nefħa (edima) f'riġlejk jew fil-ġilda (dawn jistgħu jkunu sinjali ta' problemi fil-qalb).
English: Kisqali is used in women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic).
Maltese: Kisqali jintuża f'nisa li għandhom tip ta' kanċer tas-sider, pożittiv għar-riċettur tal-ormoni, negattiv għar-riċettur tal-fattur tat-tkabbir epidermali uman 2 li huwa lokalment avanzat jew ikun infirex għal partijiet oħra tal-ġisem (metastatiku).
English: Dose interruptions/adjustments were reported in 2.3% of Kisqali plus aromatase inhibitor or fulvestrant treated patients due to electrocardiogram QT prolonged and syncope.
Maltese: Interruzzjonijiet/aġġustamenti fiddoża kienu rrappurtati fi 2.3% tal-pazjenti ttrattati b'Kisqali flimkien mal-inibitur ta' aromatase jew fulvestrant minħabba QT imtawwal fuq l-elettrokardjogramm u sinkope.
English: • Some medicines used to treat fungal infections, such as ketoconazole, itraconazole,
Maltese: • Xi mediċini użati biex jittrattaw infezzjonijiet ikkawżati minn fungi, bħal ketoconazole,
English: 2/ End of 2016
Maltese: 2/ Tmiem l-2016
English: Study protocol by:
Maltese: Protokoll tal-istudju sa:
English: The primary composite endpoint is 90-day mortality and 90-days renal failure.
Maltese: Il-punt ta' tmiem kompost primarju huwa ta' 90 jum ta' mortalità u 90 jum ta' insuffiċjenza renali.
English: Within 1 week from CMDh adopted position
Maltese: Fi żmien ġimgħa millpożizzjoni adottata misCMDh
English: - Haemodynamic stabilisation in relation to dose (e.g. Heart rate, mean arterial pressure, central venous pressure, central venous oxygen saturation, serum lactate level, base excess and urine output) - length of stay, morbidity, coagulation, inflammation, hospital mortality - measurement of creatinine (GFR) 1/ The protocol of the studies should be submitted to the NCAs 2/ Final study reports by:
Maltese: - L-istabbilizzazzjoni emodinamika fir-rigward tad-doża (eż. ir-rata tat-taħbit tal-qalb, il-pressjoni arterjali medja, il-pressjoni venuża ċentrali, is-saturazzjoni ċentrali tal-ossiġnu fil-vini, il-livell lattat fisserum, l-eċċess tal-bażi u l-ħruġ ta' awrina) - it-tul tar-rikoveru, il-morbidità, il-koagulazzjoni, l-infjammazzjoni, il-mortalità fl-isptar - il-kejl tal-kreatina (GFR)
English: The MAH(s) should submit the core elements (including protocol of DUS, protocol of the RCTs) of a risk management plan in EU format.
Maltese: L-MAH(s) għandu/għandhom jissottometti/jissottomettu l-elementi ewlenin (inkluż il-protokoll tad-DUS, il-protokoll tal-RCTs) ta' pjan ta' ġestjoni tar-riskju fil-format tal-UE.
English: The secondary endpoints are: - major peri-operative complications (e.g. infections, bleedings, anastomosis insufficiency, reoperation rate, diagnosis of pulmonary oedema).
Maltese: Il-punti ta' tmiem sekondarji huma: - kumplikazzjonijiet perioperattivi ewlenin (eż. infezzjonijiet, fsada, insuffiċjenza tal-anastamożi, rata ta' operazzjonijiet mill-ġdid, dijanjosi ta' edema pulmonari).
English: DHPC Communication circulation according to the PRAC agreed communication plan and conditions.
Maltese: Ċirkolazzjoni tal-Komunikazzjoni DHPC skont il-pjan ta' komunikazzjoni miftiehem u l-kundizzjonijiet tal-PRAC.
English: The MAH(s) should perform two phase IV randomised clinical trials (RCTs) with an appropriate control and clinically meaningful endpoints to demonstrate the efficacy and safety in the perioperative setting and trauma.
Maltese: IV b'kontroll xieraq u punti ta' tmiem klinikament sinifikanti biex tintwera l-effikaċja u s-sigurtà f'iffissar perioperattiv u f'trawma.
English: The MAH(s) should conduct a drug utilisation study in several Member States to evaluate the effectiveness of the risk minimisation measures taken.
Maltese: L-MAH(s) għandu/għandhom iwettaq/iwettqu studju ta' użu talmediċini f'diversi Stati Membri biex jevalwa(w) l-effikaċja tal-miżuri għall-minimizzazzjoni tar-riskju meħuda.
English: Pyelonephritis.
Maltese: • Pajelonefrite.
English: Based on the submitted data, including studies by Hoberman, 2011, Tähtinen, 2011, Pessey, 1999, Gooch, 1996, McLinn, 1994, McLinn, 1990, Schwarz, 1991, Brodie, 1990 and Pichichero, 1990, the CHMP considered the proposed indication to be acceptable.
Maltese: Skont id-dejta ppreżentata, inklużi studji minn Hoberman, 2011, Tähtinen, 2011, Pessey, 1999, Gooch, 1996, McLinn, 1994, McLinn, 1990, Schwarz, 1991, Brodie, 1990 u Pichichero, 1990, isCHMP ikkunsidra li l-indikazzjoni proposta hija aċċettabbli.
English: Cystitis.
Maltese: • Ċistite.
English: “Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1).
Maltese: “Zinnat huwa indikat għall-kura tal-infezzjonijiet elenkati hawn taħt fl-adulti u fit-tfal mill-età ta' 3 xhur (ara s-sezzjonijiet 4.4 u 5.1).