FrancophonIA/ELRC3.0 huggingface dataset:
English: • Depression, you may experience decreased self-esteem, lack of motivation, sadness or low mood
Maltese: • Depressjoni, jista' jkollok tnaqqis fl-awtostima, nuqqas ta' motivazzjoni, dwejjaq jew burdata depressa
English: The carcinogenic potential of telotristat etiprate was studied in transgenic mice (26 weeks) and rats (104 weeks).
Maltese: Ir-riskju ta' kanċer ta' telotristat etiprate ġie studjat fi ġrieden (26 ġimgħa) u firien (104 ġimgħat) transġeniċi.
English: In patients with carcinoid syndrome, telotristat resulted in reductions in u5-HIAA (refer to Table 3 for TELESTAR and information provided for TELECAST).
Maltese: F'pazjenti bis-sindrome karċinojde, telotristat irriżulta fi tnaqqis f'u5-HIAA (irreferi għal Tabella 3 għal TELESTAR u informazzjoni pprovduta għal TELECAST).
English: Study week
Maltese: KLINIKU
English: BMs/day at baseline
Maltese: BMs/jum fil-linja bażi
English: The percent change from baseline in u5-HIAA excretion at week 12 was +97.7% in the placebo group versus -33.2% in the 250 mg group.
Maltese: Il-bidla perċentwali mil-linja bażi fit-tneħħija ta' u5HIAA f'Ġimgħa 12 kienet ta' 97.7% fil-grupp tal-plaċebo kontra -33.2% fil-grupp ta' 250 mg.
English: In Phase 1 studies, dosing with telotristat ethyl in healthy subjects (dose range: 100 mg once daily to 500 mg tid) produced statistically significant reductions from baseline in whole blood serotonin and 24-hour urinary 5-hydroxyindoleacetic acid (u5-HIAA) compared with placebo.
Maltese: Fl-istudji ta' Fażi 1, id-dożaġġ b'telotristat ethyl f'individwi b'saħħithom (medda tad-doża: 100 mg darba kuljum sa 500 mg tid) ipproduċa tnaqqis statistikament sinifikanti mil-linja bażi fis-serotonin fid-demm sħiħ u f'5-hydroxyindoleacetic acid (u5-HIAA) fl-awrina wara 24 siegħa meta mqabbel mal-plaċebo.
English: Telotristat ethyl 250 mg tid u5-HIAA excretion (mg/24 hours) at baseline
Maltese: Tneħħija ta' u5HIAA (mg/24 siegħa) fil-linja bażi
English: Patients with a mean reduction of at least 2 BM per day: 33.3% (telotristat ethyl 250 mg) and 4.4% (placebo).
Maltese: 20.0% (plaċebo); - Pazjenti bi tnaqqis medju ta' mill-inqas 2 BM kuljum: 33.3% (telotristat ethyl 250 mg) u 4.4%
English: The efficacy and safety of telotristat for the treatment of carcinoid syndrome in patients with metastatic neuroendocrine tumours who were receiving SSA therapy was established in a 12-week double-blind, placebo-controlled, randomised, multicentre phase 3 trial in adult patients, which included a 36-week extension during which all patients were treated with open-label telotristat (TELESTAR Study).
Maltese: L-effikaċja u s-sigurtà ta' telotristat għall-kura tas-sindrome karċinojde f'pazjenti b'tumuri newroendokrinali metastatiċi li kienu qed jirċievu terapija b'SSA, ġew stabbiliti fi prova ta' Fażi 3 li damet 12-il ġimgħa, double-blind, ikkontrollata bi plaċebo, li fiha l-parteċipanti ntgħażlu b'mod każwali, multiċentrika, f'pazjenti adulti, li kienet tinkludi estensjoni ta' 36 ġimgħa li matulha lpazjenti kollha ġew ikkurati b'open-label telotristat (Studju TELESTAR).
English: In rabbits the NOAEL for maternal and prenatal toxicity is 125 mg/kg/d corresponding to 1.5 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Maltese: Fil-fniek, in-NOAEL għat-tossiċità materna u ta' qabel it-twelid, hu ta' 125 mg/kg/jum, li jikkorrispondi għal 1.5 sa 4 darbiet tal-esponiment uman stmat (AUC0-24) talmetabolit attiv LP-778902 fl-MRHD.
English: Xermelo contains lactose (a type of sugar).
Maltese: Din il-mediċina fiha l-lactose (tip ta' zokkor).
English: The pharmacokinetics of telotristat ethyl and its active metabolite have been characterised in healthy volunteers and patients with carcinoid syndrome.
Maltese: Il-farmakokinetika ta' telotristat ethyl u l-metabolit attiv tiegħu kienu kkaratterizzati f'voluntiera b'saħħithom u pazjenti bis-sindrome karċinojde.
English: In patients with moderate hepatic impairment (Child Pugh score B), it may be necessary to reduce the dose to 250 mg once daily according to tolerability.
Maltese: F'pazjenti b'indeboliment moderat tal-fwied (punteġġ ta' Child Pugh B), jista' jkun meħtieġ tnaqqis fid-doża għal 250 mg darba kuljum skont ittollerabilità.
English: They were generally of mild or moderate intensity.
Maltese: Ġeneralment dawn kienu ta' intensità ħafifa jew moderata.
English: Constipation was reported in 5.7% of patients (4/70) in the telotristat ethyl 250 mg group and in 4.2% of patients (3/71) in the placebo group.
Maltese: L-istitikezza ġiet irrappurtata f'5.7% tal-pazjenti (4/70) fil-grupp ta' telotristat ethyl 250 mg u f'4.2% tal-pazjenti (3/71) fil-grupp tal-plaċebo.
English: Xermelo 250 mg film-coated tablets
Maltese: Xermelo 250 mg pilloli miksija b'rita
English: Fatigue may occur following administration of telotristat (see section 4.8).
Maltese: Tista' sseħħ għejja wara l-għoti ta' telotristat (ara sezzjoni 4.8).
English: Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome.
Maltese: Is-serotonin għandu rwol kritiku fir-regolazzjoni ta' diversi proċessi fiżjoloġiċi maġġuri, li jinkludu sekrezzjoni, motilità, infjammazzjoni, u s-sensazzjoni tal-passaġġ gastro-intestinali, u jitnixxa b'mod eċċessiv f'pazjenti bis-sindrome karċinojde.
English: The adverse event was observed in clinical trials with frequency “very common” and is being reported from post-marketing setting.
Maltese: L-avveniment avvers kien osservat fi provi kliniċi bi frekwenza “komuni ħafna” u qiegħed jiġi rrappurtat mill-ambjent ta' wara t-tqegħid fis-suq.
English: Concomitant use of Xermelo may decrease the efficacy of medicinal products that are CYP3A4 substrates (e.g. midazolam, everolimus, sunitinib, simvastatin, ethinyloestradiol, amlodipine, cyclosporine…) by decreasing their systemic exposure (see section 5.2).
Maltese: (eż. midazolam, everolimus, sunitinib, simvastatin, ethinyloestradiol, amlodipine, cyclosporine…) billi jnaqqas l-esponiment sistemiku tagħhom (ara sezzjoni 5.2).
English: There is limited clinical experience with telotristat overdose in humans.
Maltese: Hemm esperjenza klinika limitata b'doża eċċessiva ta' telotristat fil-bnedmin.
English: In patients with mild hepatic impairment (Child Pugh score A), it may be necessary to reduce the dose to 250 mg twice daily according to tolerability.
Maltese: F'pazjenti b'indeboliment ħafif tal-fwied (punteġġ ta' Child Pugh A), jista' jkun meħtieġ tnaqqis fiddoża għal 250 mg darbtejn kuljum skont it-tollerabilità.
English: The mean PK parameters for telotristat ethyl and the active metabolite appeared unchanged between week 24 and week 48, suggesting the achievement of steady-state conditions at or prior to week 24.
Maltese: Ilparametri medji tal-PK għal telotristat ethyl u l-metabolit attiv dehru mhux mibdula bejn Ġimgħa 24 u Ġimgħa 48, li jissuġġerixxi l-kisba ta' kundizzjonijiet fl-istat fiss fi jew qabel Gimgħa 24.
English: • Breathing problems, rapid heartbeat, fever, incontinence (uncontrollable urination), confusion, dizziness or agitation.
Maltese: • Problemi biex tieħu nifs, taħbit tal-qalb mgħaġġel, deni, inkontinenza (diffiċli tikkontrolla lawrina), konfużjoni, sturdament jew aġitazzjoni.
English: In phase 3 clinical trials, telotristat was routinely combined with loperamide with no evidence of safety concerns.
Maltese: Fi provi kliniċi ta' Fażi 3, telotristat kien kombinat b'mod regolari flimkien ma' loperamide bla ebda evidenza ta' tħassib dwar is-sigurtà.
English: • Your doctor may carry out blood tests before you start taking this medicine and while you are taking it.
Maltese: • It-tabib tiegħek jista' jagħmel testijiet tad-demm qabel ma tibda tieħu din il-mediċina u waqt li tkun qed teħodha.
English: In a hepatic impairment study conducted at a single dose of 500 mg, exposures to the parent compound and its active metabolite (based on AUC0-tlast) were higher in patients with mild hepatic impairment (2.3- and 2.4-fold, respectively) and in patients with moderate hepatic impairment (3.2and 3.5-fold, respectively) compared with healthy subjects.
Maltese: Fi studju dwar indeboliment tal-fwied li twettaq b'doża waħda ta' 500 mg, l-esponimenti għallkompost ewlieni u l-metabolit attiv tiegħu (ibbażat fuq AUC0-tlast) kienu ogħla f'pazjenti b'indeboliment ħafif tal-fwied (2.3 u 2.4 darbiet, rispettivament), u f'pazjenti b'indeboliment moderat tal-fwied (3.2 u 3.5 darbiet, rispettivament) meta mqabbla ma' individwi b'saħħithom.
English: Mean Change from Baseline (and 95% CL) in Bowel Movements (counts/day)
Maltese: Bidla Medja mil-Linja Bażi (u 95% CL) fl-Ippurgar (għadd/jum)
English: 90 film-coated tablets 180 film-coated tablets
Maltese: 90 pillola miksija b'rita 180 pillola miksija b'rita
English: The NOAEL for parental / maternal / prenatal and postnatal toxicity is 500 mg/kg/day in rats corresponding to 3 to 4 times the estimated human exposure (AUC0-24) of the active metabolite LP-778902 at the MRHD.
Maltese: In-NOAEL għat-tossiċità parentali/materna/qabel it-twelid u wara t-twelid, hu ta' 500 mg/kg/jum fil-firien, li jikkorrispondi għal 3 sa 4 darbiet tal-esponiment uman stmat (AUC0-24) talmetabolit attiv LP-778902 fl-MRHD.
English: There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome.
Maltese: M'hemm l-ebda użu rilevanti ta' telotristat fil-popolazzjoni pedjatrika fl-indikazzjoni ta' sindrome karċinojde.
English: This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902.
Maltese: Dan hu bejn wieħed u ieħor 14-il darba tal-esponiment uman (AUC totali) fid-doża massima rakkomandata fil-bniedem (MRHD, maximum recommended human dose) ta' 750 mg/jum għall-metabolit attiv LP-778902.
English: Table 1 - Adverse reactions reported in patients treated with Xermelo System organ class
Maltese: Tabella 1 - Reazzjonijiet avversi rrappurtati f'pazjenti kkurati b'Xermelo
English: This medicine contains the active substance telotristat ethyl.
Maltese: X'inhu Xermelo Din il-mediċina fiha s-sustanza attiva telotristat ethyl.
English: • Wind
Maltese: • Deni
English: Xermelo contains anhydrous lactose as an excipient.
Maltese: Xermelo fih anhydrous lactose bħala eċċipjent.
English: Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg).
Maltese: Żidiet f'ALT ta' >3 × il-limitu ta' fuq tan-normal (ULN) jew ALP>2 ULN ġew irrappurtati f'pazjenti li kienu qed jirċievu terapija b'telotristat, bil-biċċa l-kbira tal-każijiet li jiġu rrappurtati f'doża ogħla (500 mg).
English: The majority of intestinal obstruction events were serious (56 cases) and 33 cases were medically confirmed.
Maltese: Ilmaġġoranza tal-avvenimenti ta' sadd intestinali kienu serji (56 każ) u 33 każ kienu kkonfermati b'mod mediku.
English: The most frequently reported adverse reaction leading to discontinuation of telotristat was abdominal pain in 7.1% of patients (5/70).
Maltese: Ir-reazzjoni avversa li ġiet irrappurtata l-aktar frekwentement li wasslet għat-twaqqif ta' telotristat kien uġigħ addominali f'7.1% tal-pazjenti (5/70).
English: A study was conducted to investigate the impact of renal impairment on the pharmacokinetics of a single dose of telotristat ethyl 250 mg.
Maltese: Twettaq studju biex jiġi investigat l-impatt tal-indeboliment tal-kliewi fuq il-farmakokinetika ta' doża waħda ta' telotristat ethyl 250 mg.
English: Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.
Maltese: Disturbi gastrointestinali li jinkludu tqalligħ, dijarea, uġigħ addominali u rimettar ġew irrappurtati f'individwi b'saħħithom li ħadu doża waħda ta' 1,500 mg fi studju ta' Fażi 1.
English: Cytochromes
Maltese: Stitikezza
English: The potential of telotristat ethyl as an inducer of CYP3A4 was not assessed at concentrations expectable at the intestinal level, due to its low solubility in vitro.
Maltese: Il-potenzjal ta' telotristat ethyl bħala induttur ta' CYP3A4 ma ġiex evalwat f'konċentrazzjonijiet li jkunu mistennija fil-livell intestinali, minħabba s-solubilità baxxa tiegħu in vitro.
English: Telotristat ethyl and telotristat have a low renal elimination following oral administration (less than 1% of the dose recovered from the urine).
Maltese: Telotristat ethyl u telotristat għandhom eliminazzjoni baxxa mill-kliewi wara għoti orali (inqas minn 1% tad-doża rkuprata mill-awrina).
English: White to off-white film-coated oval tablets (approximately 17 mm long by 7.5 mm wide) with ‘T-E' debossed on one side and ‘250' debossed on the other side.
Maltese: Pilloli miksija b'rita, ovali, ta' lewn minn abjad sa abjad jagħti fil-griz (madwar 17 mm twal u 7.5 mm wiesa') b'‘T-E' imnaqqxa fuq naħa waħda u ‘250' imnaqqxa fuq in-naħa l-oħra.
English: There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain.
Maltese: Ma kien hemm l-ebda differenza sinifikanti bejn il-gruppi tal-kura għall-punti aħħarin ta' fwawar u wġigħ addominali.
English: At the conclusion of the 12-week DBT period, 115 patients (85.2%) entered the 36-week open-label extension period, where all patients were titrated to receive a higher dose of telotristat ethyl (500 mg) tid.
Maltese: Fit-tmien tal-perjodu DBT ta' 12-il ġimgħa, 115-il pazjent (85.2%) daħlu fl-istudju ta' estensjoni open-label ta' 36 ġimgħa, fejn il-pazjenti kollha kienu ttitrati biex jirċievu doża ogħla ta' telotristat ethyl (500 mg) tid.
English: PVC/PCTFE/PVC/Al blister The blisters are packaged in a carton.
Maltese: Il-pilloli huma ppakkjati f'folja tal-PVC/PCTFE/PVC/Al.
English: CentralPharma Communications OÜ
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Clinical signs were limited to increase in frequency of liquid faeces at all doses.
Maltese: Is-sinjali kliniċi kienu limitati għal żieda fil-frekwenza ta' ppurgar likwidu fid-dożi kollha.
English: Lactose intolerance
Maltese: GĦAMLA FARMAĊEWTIKA
English: Posology The recommended dose is 250 mg three times daily (tid).
Maltese: Pożoloġija Id-doża rakkomandata hija ta' 250 mg tliet darbiet kuljum (tid).
English: Management of overdose Treatment of an overdose should include general symptomatic management.
Maltese: Kura ta' doża eċċessiva għandha tinkludi mmaniġġjar sintomatiku ġenerali.
English: This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Maltese: Dan hu bejn wieħed u ieħor 20 darba tal-esponiment uman (AUC totali) f'MRHD ta' 750 mg/jum għall-metabolit attiv LP-778902.
English: This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Maltese: Dan hu bejn wieħed u ieħor 21 darba talesponiment uman (AUC totali) f'MRHD ta' 750 mg/jum għall-metabolit attiv LP-778902.
English: In patients with carcinoid syndrome on long-acting SSA therapy, there was also a rapid conversion of telotristat ethyl to its active metabolite.
Maltese: F'pazjenti bis-sindrome karċinojde fuq terapija b'SSA li taġixxi fit-tul, kien hemm ukoll konverżjoni mgħaġġla ta' telotristat ethyl għall-metabolit attiv tiegħu.
English: Most patients (92.1%) had fewer than 4 BM per day and all except 9 were treated by SSA therapy.
Maltese: Il-biċċa l-kbira tal-pazjenti (92.1%) kellhom inqas minn 4 BM kuljum, u kollha ħlief 9 ġew ikkurati b'terapija b'SSA.
English: This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
Maltese: Dan hu bejn wieħed u ieħor 0.4 drabi tal-esponiment uman (AUC totali) f'MRHD ta' 750 mg/jum għall-metabolit attiv LP-778902.
English: Patients with a mean reduction of at least 1.5 BM per day: 46.7% (telotristat ethyl 250 mg) and 20.0% (placebo);
Maltese: BM kuljum: 46.7% (telotristat ethyl 250 mg) u
English: Abdominal distension, Constipation, Flatulence
Maltese: Uġigħ addominalia, tqalligħ
English: multicentre clinical trial in adult patients with carcinoid syndrome on long-acting SSA therapy.
Maltese: Din il-mediċina tintuża fl-adulti b'kundizzjoni msejħa ‘sindrome karċinojde'.
English: Given the high variability observed, it is recommended as a precautionary measure that patients with severe renal impairment will be monitored for signs of reduced tolerability.
Maltese: Bħala miżura ta' prekawzjoni, huwa rrakkomandat li pazjenti b'indeboliment sever tal-kliewi jiġu mmonitorjati għal sinjali ta' tollerabilità mnaqqsa.
English: In the 12-week DBT period of the study, average weekly reductions in BM frequency on telotristat were observed as early as 3 weeks, with the greatest reductions occurring during the last 6 weeks of the DBT period, compared with placebo (refer to Figure 1).
Maltese: Fil-perjodu DBT ta' 12-il ġimgħa tal-istudju, it-tnaqqis medju fil-ġimgħa fil-frekwenza ta' BM fuq telotristat ġew osservati kmieni sa minn 3 ġimgħat, bl-akbar tnaqqis li seħħ matul l-aħħar 6 ġimgħat tal-perjodu DBT, meta mqabbel mal-plaċebo (irreferi għal Figura 1).
English: The efficacy and safety in patients with end-stage renal disease who require dialysis (eGFR < 15 mL/min/1.73 m² requiring dialysis) has not been established.
Maltese: L-effikaċja u s-sigurtà f'pazjenti b'mard tal-kliewi fl-aħħar stadju li jeħtieġu dijalisi (eGFR < 15 mL/min/1.73 m² li teħtieġ dijalisi) ma ġewx stabbiliti.
English: Abdominal paina, nausea
Maltese: Effetti sekondarji oħrajn
English: Patients with a mean reduction of at least 1 BM per day: 66.7% (telotristat ethyl 250 mg) and 31.1% (placebo);
Maltese: Il-proporzjonijiet ta' pazjenti li rrappurtaw tnaqqis mil-linja bażi fil-frekwenza ta' kuljum tal-BM (bħala medja fuq 12-il ġimgħa) kienu: - Pazjenti bi tnaqqis medju ta' mill-inqas 1 BM kuljum: 66.7% (telotristat ethyl 250 mg) u 31.1%
English: These studies confirmed that telotristat did not increase the incidence of tumors in both species and sexes, at doses corresponding to an exposure of approximately 10- to 15-fold and 2- to 4.5-fold the human exposure to the active metabolite at the MRHD in mice and rats, respectively.
Maltese: Dawn l-istudji kkonfermaw li telotristat ma żiedx l-inċidenza ta' tumuri fiż-żewġ speċijiet u sessi, f'dożi li jikkorrispondu għal esponiment ta' madwar 10 sa 15-il darba u darbtejn sa 4.5 darbiet l-esponiment tal-bniedem għall-metabolit attiv fl-MRHD fil-ġrieden u l-firien, rispettivament.
English: The use of telotristat is not recommended in patients with severe hepatic impairment (Child Pugh score C) as no data are available (see section 5.2).
Maltese: L-użu ta' telotristat mhuwiex rakkomandat f'pazjenti b'indeboliment sever tal-fwied (punteġġ ta' Child Pugh C) għax m'hemm l-ebda data disponibbli (ara sezzjoni 5.2).
English: • if you have signs of constipation, as telotristat reduces the number of your bowel movements.
Maltese: • jekk ikollok sinjali ta' stitikezza, għax telotristat inaqqas in-numru ta' drabi li tipporga.
English: Shortacting octreotide should be administered at least 30 minutes after administration of Xermelo if treatment with short-acting octreotide is needed in combination with Xermelo.
Maltese: Jekk ikollok bżonn kura b'injezzjonijiet taħt il-ġilda ta' octreotide, għandek tagħmel l injezzjoni mill-inqas 30 minuta wara li tieħu Xermelo.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq issistema riproduttiva (ara 5.3).
English: • Impacted stools (bowel obstruction, faecaloma), you may experience, constipation, watery diarrhoea, pale skin (anaemia), nausea, vomiting, weight loss, back pain or stomach pains particularly after eating or a reduction in passing water (urination).
Maltese: • Wisq ħmieġ miġbur fl-imsaren (sadd fl-imsaren, fekaloma), jista' jkollok stitikezza, dijarea maħlula, ġilda pallida (anemija), tqalligħ, rimettar, telf fil-piż, uġigħ fid-dahar jew uġigħ flistonku b'mod partikolari wara l-ikel jew tgħaddi inqas awrina.
English: • Swollen stomach
Maltese: U L­UŻU
English: Fatigue
Maltese: Ċitokromi
English: After oral administration to healthy volunteers, telotristat ethyl was rapidly absorbed, and almost completely converted to its active metabolite.
Maltese: Wara l-għoti orali lil voluntiera b'saħħithom, telotristat ethyl ġie assorbit malajr, u kważi kompletament inbidel għall-metabolit attiv tiegħu.
English: Method of administration
Maltese: Sistema talklassifika talorgani
English: Xermelo contains lactose
Maltese: Xermelo fih il-lactose
English: It is unknown whether telotristat ethyl and its metabolite are excreted in human breast milk.
Maltese: Mhux magħruf jekk telotristat ethyl/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Ipsen NV
Maltese: CYPs oħrajn
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva u liżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: b. Defined as the proportion of responders with ≥30% reduction in daily number of BMs for ≥50%
Maltese: b. Definit bħala l-proporzjon ta' dawk li kellhom rispons bi tnaqqis ta' ≥30% fin-numru ta' BMs kuljum għal ≥50% tal-ħin matul il-perjodu ta' kura double-blind (DBT). c. p=0.01
English: Taking into account the PRAC Assessment Report on the PSUR(s) for telotristat, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal telotristat, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Administration of a single dose of 250 mg was well tolerated in subjects with severe to moderate renal impairment.
Maltese: L-għoti ta' doża waħda ta' 250 mg kien ittollerat tajjeb f'individwi b'indeboliment sever għal moderat tal-kliewi.
English: European Review System (Installation)
Maltese: European Review System (Installazzjoni)
English: London, 17 June 2008
Maltese: Londra, 17 ta' Ġunju 2008
English: Sensory organs
Maltese: Organi sensorjali
English: Recalls Class 1 Class 2 Class 3
Maltese: 2 Klassi 3
English: 2.5 Parallel distribution
Maltese: Distribuzzjoni parallela
English: Musculoskeletal and nervous system
Maltese: Sistemi muskoluskeletali u nervuza
English: Workshops, conferences, training
Maltese: Workshops, konferenzi, taħriġ
English: Similar biological products
Maltese: Prodotti bijologici simili
English: EMEA/197729/2008/EN/FINAL
Maltese: EMEA/421619/2008/MT/FINALI
English: EU contribution (excluding fund for orphan medicines) as % of total budget
Maltese: Kontribuzzjoni mill-UE (esklus il-fond ghal medicini orfni) bhala % tal-budget totali
English: 1.5 Transparency, communication and provision of information
Maltese: 1.5 Trasparenza, komunikazzjoni u għoti ta' informazzjoni
English: • We adhere to high standards of professional and personal integrity.
Maltese: • Aħna naderixxu ma' standards għoljin ta' integrità professjonali u personali.
English: Restrictions of indication
Maltese: Restrizzjonijiet ta' indikazzjoni
English: Genito-urinary
Maltese: Genito-urinarju
English: Oncology
Maltese: Onkologija
English: Eudra DataWarehouse (In pre-production)
Maltese: Eudra DataWarehouse (Fil-pre-produzzjoni)
English: Positive opinions
Maltese: Opinjonijiet posittivi
English: Safety review of Viracept
Maltese: Reviżjoni ta' sigurtà tal-Viracept
English: Immunology
Maltese: Immunologija
English: Anti-infectious
Maltese: Anti-infettivi
English: PIM (Product Information Management) (In pilot production)
Maltese: PIM (Product Information Management) (Fi stadju ta' produzzjoni pilota)
English: Negative opinions
Maltese: Opinjonijiet negattivi
English: Applications for new medicinal products Generic applications
Maltese: Applikazzjonijiet ghal prodotti medicinali godda Applikazzjonijiet generici