FrancophonIA/ELRC3.0 huggingface dataset:
English: Excessive lowering of blood pressure may increase the chance of heart attack or stroke in certain patients - Increased heart rate - Feeling weak - Pains in the chest - Breathing problems, including shortness of breath and tightness in the chest - A runny or blocked nose and sneezing (rhinitis) - Dry or swollen mouth - Lack of appetite - Change in the way things taste - Diarrhoea and vomiting - Skin rash (which may be severe) - Muscle cramps or pain in your muscles or joints - Impotence - Sweating more than usual - Flushing - Sleeping problems - Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets
Maltese: magnesium, calcium, bicarbonate), jew livelli elevati ta' glukosju, urate, kolesterol u trigliċeridi - Tip ta' reazzjoni allerġika severa (anafilassi) - Iskemija ċerebrali, attakk iskemiku temporanju, puplesija iskemika (jistgħu jseħħu jekk il pressjoni tad-demm tkun baxxa wisq) - Infart mijokardijaku (jista' jseħħ jekk il-pressjoni tad-demm tkun baxxa wisq) - Taħbit tal-qalb irregolari - Marda tal-interstizju tal-pulmun - Disturb li jixbħu lil lupus erythematosus sistemiku - Tingiż jew tnemnim fl-idejn jew saqajn - Tħarħir - Sensazzjoni ta' konġestjoni jew uġigħ itektek wara l-imnieħer, ħaddejn u għajnejn (sinożite).
English: - if you undergo LDL apheresis with dextrane sulphate.
Maltese: - Numru baxx ta' ċelluli ħomor tad-demm (anemija).
English: Medicinal products that could induce torsades de pointes Due to the risk of hypokalemia hydrochlorothiazide should be administered with caution when a patient is simultaneously being treated with medicinal products that could induce torsades de pointes such as:
Maltese: Prodotti mediċinali li jistgħu jinduċu torsades de pointes Minħabba r-riskju ta' ipokalimja, hydrochlorothiazide għandu jingħata b'attenzjoni meta pazjent huwa kkurat fl-istess waqt bi prodotti mediċinali li jistgħu jinduċu torsades de pointes bħal:
English: If you have an intolerance to lactose, talk to your doctor before taking this medicine.
Maltese: Jekk għandek intolleranza għal lactose, kellem littabib tiegħek qabel tieħu din il-mediċina.
English: Your doctor will normally advise you to stop taking Vascace Plus before you become pregnant, or as soon as you know you are pregnant, and will advise you to take another medicine instead of Vascace Plus.
Maltese: Normalment it-tabib tiegħek se jagħtik parir biex twaqqaf it-teħid ta' Vascace Plus qabel toħroġ tqila, jew hekk kif issir taf li inti tqila, u se jagħtik parir biex tieħu mediċina oħra minflok Vascace Plus.
English: Haemodialysis
Maltese: Mutaġeniċità
English: Cilazapril is efficiently absorbed after oral administration of Vascace Plus and rapidly converted by ester cleavage to the active form, cilazaprilat.
Maltese: Wara għoti orali ta' Vascace Plus, cilazapril huwa assorbit b'mod effiċjenti u jinbidel malajr permezz ta' qtugħ tal-ester għall-forma attiva, cilazaprilat.
English: Because significant hypotension may occur in patients with liver cirrhosis treated with standard doses of ACE inhibitors, cautious dose titration of each individual component is needed if patients with liver cirrhosis should require treatment with cilazapril and hydrochlorothiazide (see section 4.4).
Maltese: Peress li tista' sseħħ pressjoni baxxa sinifikanti f'pazjenti b'ċirrożi tal-fwied kkurati b'dożi standard ta' inibituri ta' ACE, hija meħtieġa titrazzjoni b'attenzjoni ta' kull komponent individwali jekk pazjenti b'ċirrożi tal-fwied ikollhom bżonn kura b'cilazapril u hydrochlorothiazide (ara sezzjoni 4.4).
English: Low-density lipoproteins (LDL) apheresis
Maltese: Pazjenti b'indeboliment tal-kliewi
English: Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm kontinwazzjoni tat-terapija ma tkunx ikkunsidrat essenzjali, pazjenti li qed jippjanaw li joħorġu tqala għandhom jingħataw kura alternattiva li tbaxxi l-pressjoni li għandha profil ta' sigurtà stabbilit għall-użu waqt it-tqala.
English: Since thiazide-induced hypokalaemia may occur during therapy with Vascace Plus, which may increase the risk of arrhythmia associated with digoxin therapy, monitoring of potassium plasma levels is advised.
Maltese: Peress li waqt terapija b'Vascace Plus tista' sseħħ ipokalimja kkawżata minn thiazide, li tista' iżżid irriskju ta' arritmija assoċjata ma' terapija b'digoxin, huwa rrakkomandat monitoraġġ tal-livelli talpotassju fil-plażma.
English: As with other ACE inhibitors, the kidney was the primary target of systemic toxicity in subchronic and chronic toxicity studies with cilazapril alone.
Maltese: Bħal b'inibituri oħra ta' ACE, il-kliewi kienu il-mira primarja tat-tossiċità sistemika fl-istudji ta' tossiċità subkronika u kronika b'cilazapril waħdu.
English: The bioavailability of hydrochlorothiazide after oral dose is about 65% based on urinary recovery.
Maltese: Ibbażat fuq l-irkupru mill-awrina, ilbijodisponibilità ta' hydrochlorothiazide wara doża orali hija madwar 65 %.
English: The acute oral toxicity of cilazapril in mice was not enhanced by the combination with hydrochlorothiazide.
Maltese: It-tossiċità akuta orali ta' cilazapril filġrieden ma kienitx imsaħħa mit-taħlita ma' hydrochlorothiazide.
English: Sleep disorder, depression
Maltese: Disturb fl-irqad, depressjoni
English: The signs include severe pain in the stomach which spreads to your back - Changes in the way your liver or kidneys work (shown in blood and urine tests) - Liver problems such as hepatitis (inflammation of the liver) or liver damage - Severe skin reactions including blistering or peeling of skin - Increased sensitivity to light - Hair loss (which may be temporary) - Loosening or separation of a nail from its bed - Breast enlargement in men - Depression - Confusion - Dry eyes - Yellow colour vision distortion
Maltese: Esponiment għall-kura b'inibituri ta' ACE matul it-tieni u t-tielet trimester huwa magħruf li jinduċi tossiċità lill-fetu uman (tnaqqis fil-funzjoni tal-kliewi, fluwidu amnjotiku mhux suffiċjenti, dewmien fl-ossifikazzjoni tal-qorriegħa tar-ras) u tossiċità lil trabi tat-twelid (insuffiċjenza tal-kliewi, pressjoni baxxa, iperkalimja).
English: Limited data suggest that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly patients compared to young healthy volunteers.
Maltese: Dejta limitata tissuġġerixxi li t-tneħħija sistemika ta' hydrochlorothiazide hija mnaqqsa f'pazjenti anzjani b'saħħithom u bi pressjoni għolja meta mqabbla ma' voluntiera żgħażagħ b'saħħithom.
English: Single cases of liver function disorders, such as increased values of liver function tests (transaminases, bilirubin, alkaline phosphatase, gamma GT) and cholestatic hepatitis with or without necrosis have been reported in patients treated with cilazapril.
Maltese: F'pazjenti kkurati b'cilazapril kienu irrappurtati każijiet uniċi ta' disturbi fil-funzjoni tal-fwied, bħal żjieda fil-valuri tat-testijiet tal-funzjoni tal-fwied (transaminases, bilirubin, alkaline phosphatase, gamma GT) u epatite kolestatika bi jew mingħajr nekrosi.
English: Electrolyte and renal function should be monitored in all patients receiving Vascace Plus.
Maltese: L-elettroliti u l-funzjoni tal-kliewi għandhom jiġu ssorveljati fil-pazjenti kollha li jirċievu Vascace Plus.
English: 1 ml (140 mg/ml) 1 pre-filled pen
Maltese: Il-pakkett li jmiss mal-prodott
English: MA (EU) number (Invented) name Strength
Maltese: Numru tal-MA Isem (ivvintat) Qawwa
English: Content (concentration)
Maltese: Il-Kontenut (Konċentrazzjoni)
English: 3 bottles
Maltese: 3 fliexken
English: MA (EU) Number
Maltese: Numru tal-MA (EU) Isem (Ivvintat)
English: Pack size
Maltese: Flixkun wieħed
English: Content (concentration)
Maltese: Kontenut (konċentrazzjon)
English: 1 ml (120 mg/ml) 1 pre-filled syringe
Maltese: 3 pinen mimlijin għal-lest siringa 1 mimlija għal-lest
English: 1 ml (120 mg/ml) 1 pre-filled pen
Maltese: Daqs talpakkett pinna 1 mimlija għal-lest
English: Ελλάδα, Κύπρος, Malta Ipsen Μονοπρόσωπη EΠΕ Αγ.
Maltese: Ελλάδα, Κύπρος, Malta Ipsen Μονοπρόσωπη EΠΕ
English: EU/1/17/1224/001 EU/1/17/1224/002
Maltese: EU/1/17/1224/002
English: 13522 Tallinn Estonia
Maltese: 13522 Tallinn
English: Kalnciema iela 33-5 Rīga
Maltese: Kalnciema iela 33-5
English: Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous
Maltese: Qalba tal-pillola Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous
English: Ipsen Poland Sp. z o.o.
Maltese: Ipsen Poland Sp. z o.o. Al.
English: LP-951757 was pharmacologically inactive at TPH1 in vitro.
Maltese: LP-951757 kien farmakoloġikament inattiv f'TPH1 in vitro.
English: Depressive disorders
Maltese: Disturbi depressivi
English: Table 2: BM response (TELESTAR Study) Parameter
Maltese: Tabella 2: Rispons BM (Studju TELESTAR) Parametru
English: België/Belgique/Belgien, Luxembourg/Luxemburg
Maltese: België/Belgique/Belgien, Luxembourg/Luxemburg Ipsen NV
English: • oral contraceptives, such as ethinyloestradiol.
Maltese: • kontraċettivi orali, bħal ethinyloestradiol.
English: Δημητρίου 63 Άλιμος GR-17456 Αθήνα Ελλάδα
Maltese: Αγ. Δημητρίου 63 Άλιμος GR-17456
English: Institut Produits Synthèse (IPSEN) AB Kista Science Tower Färögatan 33
Maltese: Institut Produits Synthèse (IPSEN) AB Kista Science Tower
English: Transporters
Maltese: Transportaturi
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Maltese: 65 quai Georges Gorse 92100 Boulogne-Billancourt
English: • medicines for diarrhoea.
Maltese: • mediċini kontra d-dijarea.
English: Telotristat induced CYP2B6 in vitro (see section 5.2).
Maltese: Telotristat induċa CYP2B6 in vitro (ara sezzjoni 5.2).
English: Alanine aminotransferase increased (ALT), Aspartate aminotransferase increased (AST),
Maltese: Żieda f'aspartate aminotransferase increased (AST),
English: Ipsen Pharmaceuticals Ltd. Blanchardstown Industrial Park Blanchardstown IRL-Dublin 15
Maltese: Blanchardstown Industrial Park Blanchardstown IRL-Dublin 15
English: Ipsen Pharma GmbH Einsteinstraße 174
Maltese: Deutschland, Österreich Ipsen Pharma GmbH Einsteinstraße 174
English: • The active substance is telotristat ethyl.
Maltese: • Is-sustanza attiva hi telotristat ethyl.
English: Polyvinyl alcohol (partially hydrolysed) (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521)
Maltese: Polyvinyl alcohol (parzjalment idrolizzat) (E1203) Titanium dioxide (E171)
English: Ipsen Ltd.
Maltese: United Kingdom Ipsen Ltd.
English: Ipsen Pharma SAS Magyarországi Kereskedelmi Képviselet
Maltese: Ipsen Pharma SAS Magyarországi Kereskedelmi
English: Cartons of 90 and 180 tablets.
Maltese: Kartun ta' 90 u 180 pillola.
English: Carboxylesterase (CES) inhibitors
Maltese: Inibituri ta' carboxylesterase (CES)
English: Pharmaswiss d.o.o.
Maltese: Pharmaswiss d.o.o. Brodišče 32
English: Least Square mean difference 97.5% CL for difference p value
Maltese: Differenza fil-medja tal-Inqas Kwadri 97.5% CL għaddifferenza valur p
English: CL=confidence limit; tid=three times daily; SD=standard deviation; u5-HIAA = urinary 5--hydroxyindoleacetic acid.
Maltese: CL=limitu ta' kunfidenza; tid=tliet darbiet kuljum; SD=devjazzjoni standard; u5-HIAA=5-hydroxyindoleacetic acid fl-awrina a.
English: • The other ingredients are: lactose anhydrous (see section 2 under ‘Xermelo contains lactose'), hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, colloidal anydrous silica, polyvinyl alcohol (partially hydrolysed) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) and talc (E553b).
Maltese: • Is-sustanzi mhux attivi l-oħra huma: lactose anhydrous (ara sezzjoni 2 taħt ‘Xermelo fih illactose'), hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, colloidal anydrous silica, polyvinyl alcohol (parzjalment idrolizzat) (E1203), titanium dioxide (E171), macrogol 3350 (E1521) u talc (E553b).
English: Each tablet contains 168 mg of lactose (as anhydrous).
Maltese: Kull kapsula fiha 168 mg ta' lactose (bħala anhydrous).
English: 84.8 mg/24 hours in the placebo group (n=22).
Maltese: 8 mg/24 siegħa fil-grupp tal-plaċebo (n=22).
English: The mean Cmax and AUC0-inf were 610 ng/mL and 2320 ng•hr/mL, respectively for telotristat.
Maltese: Il-medja tas-Cmax u l-AUC0-inf kienu 610 ng/mL u 2320 ng•hr/mL, rispettivament għal telotristat.
English: In vitro, telotristat ethyl inhibited CYP3A4, suggesting a potential interaction with CYP3A4 substrates.
Maltese: In vitro, telotristat ethyl inibixxa CYP3A4, li jissuġġerixxi interazzjoni potenzjali ma' sottostrati ta' CYP3A4.
English: 00-867 Warszawa Tel.: + 48 22 653 68 00
Maltese: Jana Pawła II 29 00-867 Warszawa Tel.: + 48 22 653 68 00
English: Beaufour Ipsen Industrie Rue Ethé Virton 28100 Dreux France
Maltese: Beaufour Ipsen Industrie Rue Ethé Virton 28100
English: Brodišče 32
Maltese: Färögatan 33
English: CLs were based on the HodgesLehmann estimator of the median paired difference.
Maltese: CLs kienu bbażati fuq il-Hodges-Lehmann estimator tad-differenza paired medjana.
English: b. Statistical tests used a blocked 2-sample Wilcoxon Rank Sum statistic (van Elteren test) stratified by the u5-HIAA stratification at randomization.
Maltese: b. Testijiet statistiċi użaw 2-sample Wilcoxon Rank Sum statistic imblukkata (test ta' van Elteren) stratifikata skont stratifikazzjoni ta' u5-HIAA meta saret l-għażla każwali.
English: Pack sizes of 90 and 180 tablets.
Maltese: Daqsijiet tal-pakketti ta' 90 jew 180 pillola.
English: Breast Cancer Resistance Protein (BCRP)
Maltese: Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP - breast cancer resistance protein)
English: Faecalomac, intestinal obstruction
Maltese: Fekalomac, sadd intestinali
English: The tablets are packaged in a PVC/PCTFE/PVC/Al blister.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja tal-PVC/PCTFE/PVC/Al
English: Telotristat ethyl inhibited MRP2-mediated transport (98% inhibition).
Maltese: Telotristat ethyl inibixxa t-trasport medjat minn MRP2 (inibizzjoni ta' 98%).
English: SE- 164 51 Kista
Maltese: SE- 164 51
English: Loperamide caused a <30% decrease in the formation of telotristat (active metabolite) in vitro (see section 5.2).
Maltese: Loperamide ikkawża <30% tnaqqis fil-formazzjoni ta' telotristat (metabolit attiv) in vitro (ara sezzjoni 5.2).
English: Adverse reactions are listed by MedDRA body system organ class and by frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: L-avvenimenti avversi huma elenkati skont issistema tal-klassifika tal-organi u l-frekwenza bl-użu tal-konvenzjoni li ġejja: komuni: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Telotristat reduces bowel movement (BM) frequency.
Maltese: Telotristat inaqqas il-frekwenza tal-ippurgar (BM, bowel movement).
English: 20 (44.4)c BM = bowel movement; CL=confidence limit; tid=three times daily; SD=standard deviation.
Maltese: BM=ippurgar (bowel moviment); CL=limitu ta' kunfidenza; tid=tliet darbiet kuljum; SD=devjazzjoni standard.
English: Ipsen Farmaceutica B.V. Taurusavenue 33b 2132 LS Hoofddorp Tel: + 31 (0) 23 554 1600
Maltese: Ipsen Farmaceutica B.V. Taurusavenue 33b 2132 LS Hoofddorp
English: Date of first authorisation: 18 September 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 Settembru 2017
English: The mean number of daily BM at baseline was 2.2 and 2.5 respectively in the placebo (n=25) and 250 mg group (n=25).
Maltese: In-numru medju ta' BM kuljum fil-linja bażi kien ta' 2.2 u 2.5 rispettivament fil-grupp tal-plaċebo (n=25) u fil-grupp ta' 250 mg (n=25).
English: B-9820 Merelbeke België/Belgique/Belgien Tél/Tel: + 32 - 9 - 243 96 00
Maltese: B-9820 Merelbeke België/Belgique/Belgien
English: The only metabolite of telotristat (active metabolite) representing consistently > 10% of total plasma drug-related material was its oxidative decarboxylated deaminated metabolite, LP-951757.
Maltese: L-uniku metabolit ta' telotristat (metabolit attiv) li jirrappreżenta b'mod konsistenti >10% tal-materjal totali relatat mal-mediċina fil-plażma, kien il-metabolit decarboxylated deaminated, LP-951757 ossidattiv tiegħu.
English: Xermelo 250 mg film-coated tablets telotristat ethyl
Maltese: Xermelo 250 mg pilloli miksija b'rita telotristat ethyl
English: The mean Cmax, and AUC0-inf for the active metabolite, 1'-hydroxymidazolam, were also decreased by 34%, and 48%, respectively.
Maltese: Il-medja tas-Cmax, u AUC0-inf għall-metabolit attiv, 1'-hydroxymidazolam, tnaqqsu wkoll b'34%, u 48%, rispettivament.
English: The proportions of patients who were “very satisfied” were 0/9 (0%) on placebo, 5/9 (56%) on telotristat ethyl 250 mg tid and 7/15 (47%) on a higher dose of telotristat ethyl.
Maltese: Il-proporzjonijiet ta' pazjenti li kienu “sodisfatti ħafna” kienu ta' 0/9 (0%) fuq il-plaċebo, 5/9 (56%) fuq telotristat ethyl 250 mg tid, u 7/15 (47%) fuq doża ogħla ta' telotristat ethyl.
English: In vitro telotristat ethyl inhibited BCRP (IC50 = 20 µM), but its active metabolite telotristat did not show any significant inhibition of BCRP activity (IC50 > 30 µM).
Maltese: In vitro, telotristat ethyl inibixxa BCRP (IC50 = 20 µM), iżda l-metabolit attiv tiegħu telotristat ma wera l-ebda inibizzjoni sinifikanti tal-attività ta' BCRP (IC50 > 30 µM).
English: In a 26-week repeat-dose toxicity study in rats a No-Observed Adverse Effect Level (NOAEL) of 50 mg/kg/day was determined.
Maltese: Osservat (NOAEL, No Observed Adverse Effect Level) ta' 50 mg/kg/jum.
English: In dogs decreases in brain 5-HT and 5-HIAA levels were observed at dose of 200 mg/kg/day and 30 mg/kg/day of telotristat etiprate per os, respectively.
Maltese: Fil-klieb, tnaqqis ta' 5-HT fil-moħħ fil-livelli ta' 5-HIAA ġew osservati f'doża ta' 200 mg/kg/jum u 30 mg/kg/jum ta' telotristat etiprate kull os, rispettivament.
English: The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni f'pazjenti kkurati b'telotristat kienu wġigħ addominali (26%), żieda f'gamma-glutamyl transferase (11%) u għeja (10%).
English: • medicines to treat depression, such as bupropion or sertraline.
Maltese: • mediċini għall-kura tad-depressjoni, bħal bupropion jew sertraline.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products: Various alimentary tract and metabolism products, ATC code: A16AX15
Maltese: Prodotti oħra tal-apparat alimentari u tal-metaboliżmu: Prodotti varji tal-apparat alimentari u tal-metaboliżmu, Kodiċi ATC:
English: Systemic exposure to LP-951757 was about 35% of the systemic exposure to telotristat (active metabolite) in the mass balance study.
Maltese: L-esponiment sistemiku għal LP-951757 kien ta' madwar 35% tal-esponiment sistemiku għal telotristat (metabolit attiv) fl-istudju dwar ilbilanċ tal-massa.
English: Depression, depressed mood and decreased interest have been reported in clinical trials and from postmarketing in some patients treated with telotristat (see section 4.8).
Maltese: Depressjoni, burdata depressa u tnaqqis fl-interess ġew irrappurtati fil-provi kliniċi u wara t-tqegħid fis-suq f'xi pazjenti kkurati b'telotristat (ara sezzjoni 4.8).
English: Based on the small increase observed, clinically meaningful interactions with P-gp and MRP-2 substrates are unlikely.
Maltese: Ibbażat fuq iżżieda żgħira osservata, interazzjonijiet klinikament sinifikanti ma' sottostrati ta' P-gp u MRP-2 mhumiex probabbli.
English: The mean age was 64 years (range 37 to 88 years), 52% were male and 90% were white.
Maltese: L-età medja kienet ta' 64 sena (medda minn 37 sa 88 sena), 52% kienu rġiel u 90% kienu bojod.
English: Table 3: u5-HIAA excretion at baseline and week 12 (TELESTAR Study) Parameter
Maltese: Tabella 3: Tneħħija ta' u5-HIAA fil-linja bażi u f'Ġimgħa 12 (Studju TELESTAR)
English: In vitro telotristat (active metabolite) caused a concentration dependent increase in CYP2B6 mRNA levels (>2-fold increase and > 20% of the positive control, with a maximum observed effect similar to the positive control), suggesting possible CYP2B6 induction (see section 4.5).
Maltese: In vitro, telotristat (metabolit attiv) ikkawża żieda dipendenti fuq il-konċentrazzjoni fil-livelli ta' CYP2B6 mRNA (żieda ta' >2 u >20% tal-kontroll pożittiv, b'effett massimu osservat effett simili għall-kontroll pożittiv), li jissuġġerixxi l-induzzjoni possibbli ta' CYP2B6 (ara sezzjoni 4.5).
English: It may harm them,
Maltese: Nefħa addominali, Stitikezza,
English: Ipsen Pharma, s.r.o.
Maltese: Česká republika Ipsen Pharma, s.r.o.
English: Selise 26 - 11
Maltese: CentralPharma Communications OÜ Selise 26 - 11
English: The most frequently reported adverse event in patients receiving telotristat ethyl 250 mg tid was abdominal pain (25.7%; 18/70) versus placebo (19.7%; 14/71).
Maltese: L-avveniment avvers irrappurtat b'mod l-aktar frekwenti f'pazjenti li qed jirċievu telotristat ethyl 250 mg tid kien uġigħ addominali (25.7%; 18/70) kontra l-plaċebo (19.7%; 14/71).
English: Number of Patients Percent Change at Week 12: Mean (SD) Estimate of Treatment Difference (95% CL)b
Maltese: Stima tad-Differenza filKura (95% CL)b
English: Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
Maltese: Il-varjabilità tal-parametri prinċipali tal-PK ta' LP-778902 fil-plażma kienet ogħla f'individwi b'indeboliment sever għal moderat tal-kliewi, b'CV% li jvarja minn 53.3% għas-Cmax għal 77.3% għall-AUC meta mqabbel ma' 45.4% għas-Cmax u 39.7% għall-AUC f'individwi f'saħħithom għal b'indeboliment ħafif, rispettivament.
English: Serious constipation was observed in 3 patients treated with a higher dose (500 mg) in the overall safety population (239 patients).
Maltese: Stitikezza serja ġiet osservata fi 3 pazjenti kkurati b'doża ogħla (500 mg) fil-popolazzjoni globali tas-sigurtà (239 pazjent).
English: A study examining the effect of short-acting octreotide (3 doses of 200◦micrograms given 8◦hours apart) on the single dose pharmacokinetics of Xermelo in normal healthy volunteers showed an 83% and 81% decrease in Cmax and AUC of telotristat ethyl and telotristat, respectively (see section 4.5).
Maltese: Studju li eżamina l-effett ta' octreotide li jaġixxi għal żmien qasir (3 dożi ta' 200 mikrogramma mogħtija f'intervall ta' 8 sigħat) fuq il-farmakokinetika ta' doża waħda ta' Xermelo f'voluntiera b'saħħithom normali, wera tnaqqis ta' 83% u 81% fis-Cmax u fl-AUC ta' telotristat ethyl u telotristat, rispettivament (ara sezzjoni 4
English: Blood alkaline phosphatase increased (ALP)
Maltese: Żieda f'alkaline phosphatase fid-demm (ALP)
English: Gammaglutamyltransferase increasedb
Maltese: Żieda f'gammaglutamyltransferaseb
English: Depression, depressed mood
Maltese: Depressjoni, burdata depressa
English: A high variability (% CV range of 18% to 99%) in telotristat ethyl and its active metabolite parameters was observed within the overall PK.
Maltese: Varjabbiltà għolja (medda ta' % CV ta' 18% sa 99%) f'telotristat ethyl u l-parametri tal-metabolit attiv tiegħu, ġiet osservata fil-PK globali.
English: Concomitant use of telotristat etiprate (Xermelo, the hippurate salt of telotristat ethyl) with acidreducers (omeprazole and famotidine) showed that the AUC of telotristat ethyl was increased 2-3 fold, while the AUC of the active metabolite (telotristat) was not changed.
Maltese: L-użu ta' telotristat etiprate (Xermelo, il-hippurate salt ta' telotristat ethyl) flimkien ma' sustanzi li jnaqqsu l-aċidu (omeprazole u famotidine) wera li l-AUC ta' telotristat ethyl żdiedet bi 2-3 darbiet, filwaqt li l-AUC tal-metabolit attiv (telotristat) ma nbidlitx.