FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Xermelo is not recommended in patients with end-stage renal disease requiring dialysis (eGFR < 15 mL/min requiring dialysis) because efficacy and safety of Xermelo in these patients has not been established.
Croatian: Uporaba Xermela se ne preporučuje u bolesnika s terminalnim stadijem bubrežne bolesti koji zahtijevaju dijalizu (eGFR <15 ml/min koji zahtijeva dijalizu) jer nije utvrđena djelotvornost i sigurnost Xermela u tih bolesnika.
English: The European Medicines Agency has waived the obligation to submit the results of studies with telotristat in all subsets of the paediatric population in the treatment of carcinoid syndrome (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka telotristata u svim podskupinama pedijatrijske populacije u liječenju karcinoidnog sindroma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Administration of a single dose of 500 mg was well tolerated.
Croatian: Primjena jedne doze od 500 mg dobro se podnosila.
English: • medicines used to treat high blood pressure, such as amlodipine.
Croatian: • lijekove kojima se liječi visoki krvni tlak, kao što je amlodipin
English: This is because the medicine has not been tested in this age group.
Croatian: To je zbog toga što lijek nije ispitan u toj dobnoj skupini.
English: Pack sizes of 90 and 180 tablets.
Croatian: Veličine pakiranja od 90 i 180 tableta.
English: When the tumour releases too much serotonin into your bloodstream you can get diarrhoea.
Croatian: Kada tumor otpušta previše serotonina u krvotok, može time uzrokovati proljev.
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Croatian: 65 quai Georges Gorse 92100 Boulogne-Billancourt
English: Women of childbearing potential should be advised to use adequate contraception during treatment with telotristat.
Croatian: Ženama reproduktivne dobi treba savjetovati da tijekom liječenja telotristatom koriste odgovarajuću kontracepciju.
English: This could mean that your doctor needs to change the dose(s) that you take.
Croatian: To može značiti da Vam liječnik mora promijeniti dozu/doze koje uzimate.
English: Clinical signs were limited to increase in frequency of liquid faeces at all doses.
Croatian: Klinički znakovi su bili ograničeni na veću učestalost tekućeg fecesa pri svim dozama.
English: Other medicines and Xermelo
Croatian: Drugi lijekovi i Xermelo
English: Overall, severe to moderate renal impairment did not result in a clinically meaningful change in the PK profile or safety of telotristat ethyl and its metabolite telotristat.
Croatian: Sveukupno, teška do umjerena oštećenja funkcije bubrega nisu dovela do klinički značajne promjene u farmakokinetičkom profilu ili sigurnosti etiltelotristata i njegovog metabolita telotristata.
English: There are no data from the use of telotristat in pregnant women.
Croatian: Nema podataka o primjeni telotristata u trudnica.
English: • if you have end-stage kidney disease or are on dialysis.
Croatian: • ako bolujete od bolesti bubrega u završnom stadiju ili ste na dijalizi.
English: For clinical management of elevated hepatic enzymes, see section 4.4.
Croatian: Za kliničko zbrinjavanje povišenih jetrenih enzima vidjeti dio 4.4.
English: Prenatal development in rats and rabbits was affected by increased prenatal lethality (increased early and late resorptions), while no adverse effects were noted on postnatal development in rats.
Croatian: U prenatalnom razvoju štakora i kunića pokazao se porast prenatalne smrtnosti (povećane rane i kasne resorpcije), dok u postnatalnom razvoju u štakora nisu opaženi štetni učinci.
English: They were generally of mild or moderate intensity.
Croatian: Nuspojave su bile većinom blage ili umjerene jačine.
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.
Croatian: Jedini metabolit telotristata (aktivni metabolit) koji u plazmi dosljedno čini > 10% ukupnog materijala povezanog s lijekom bio je njegov oksidativni dekarboksilirani dezaminirani metabolit, LP-951757.
English: Telotristat may have a small effect on your ability to drive or use any tools or machines.
Croatian: Telotristat može imati mali učinak na Vašu sposobnost upravljanja vozilima ili rukovanja alatima ili strojevima.
English: The secondary objective of this study was to evaluate changes in patients' quality of life (QOL) through Week 84.
Croatian: Sekundarni cilj ovog ispitivanja bila je procjena promjena u kvaliteti života bolesnika tijekom 84 tjedna.
English: • if you have signs of constipation, as telotristat reduces the number of your bowel movements.
Croatian: • ako imate znakove zatvora, jer telotristat smanjuje broj pražnjenja crijeva.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti” i „EXP”.
English: The increases were largely reversible on dose interruption or reduction, or recovered whilst maintaining treatment at the same dose.
Croatian: Povišenja su uglavnom bila reverzibilna kada je primjena doze privremeno prekinuta ili je doza smanjena, ili su se vrijednosti vratile na normalne vrijednosti kada se liječenje održavalo pri istoj dozi.
English: Beaufour Ipsen Industrie Rue Ethé Virton 28100 Dreux France
Croatian: Beaufour Ipsen Industrie Rue Ethé Virton 28100 Dreux Francuska
English: Hepatic enzymes elevations
Croatian: Povišenja jetrenih enzima
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.
Croatian: Djelotvornost i sigurnost u bolesnika s terminalnim stadijem bubrežne bolesti koji zahtijevaju dijalizu (eGFR < 15 ml/min/1,73 m² koji zahtijeva dijalizu) nisu utvrđene.
English: Number of Patients Percent Change at Week 12: Mean (SD) Estimate of Treatment Difference (95% CL)b
Croatian: Postotak promjene u 12. tjednu: srednja vrijednost (SD) Procjena terapijske razlike (95% CL)
English: It is unknown whether telotristat ethyl and its metabolite are excreted in human breast milk.
Croatian: Nije poznato izlučuju li se etiltelotristat i njegov metabolit u majčino mlijeko.
English: CL=confidence limit; tid=three times daily; SD=standard deviation; u5-HIAA = urinary 5--hydroxyindoleacetic acid.
Croatian: CL = granica pouzdanosti; TID = tri puta na dan; SD = standardna devijacija; u5-HIAA = 5-hidroksiindoloctena kiselina u mokraći a.
English: Each tablet contains 168 mg of lactose (as anhydrous).
Croatian: Jedna tableta sadrži 168 mg laktoze (bezvodne).
English: Patients should not breast-feed during telotristat treatment.
Croatian: Bolesnice ne smiju dojiti tijekom liječenja telotristatom.
English: Ipsen Pharma GmbH Einsteinstraße 174
Croatian: Deutschland, Österreich Ipsen Pharma GmbH Einsteinstraße 174
English: The pharmacokinetics of telotristat ethyl and its active metabolite have been characterised in healthy volunteers and patients with carcinoid syndrome.
Croatian: Značajke farmakokinetike etiltelotristata i njegova aktivnog metabolita opisane su u zdravih dobrovoljaca i bolesnika s karcinoidnim sindromom.
English: The mean age was 63 years (range 35 to 84 years), 55% were male and 97% were white.
Croatian: Srednja dob bila je 63 godine (raspon od 35 do 84 godine), 55% bolesnika bili su muškarci, a 97% bijelci.
English: Telotristat ethyl and telotristat have a low renal elimination following oral administration (less than 1% of the dose recovered from the urine).
Croatian: Etiltelotristat i telotristat imaju nisku bubrežnu eliminaciju nakon peroralne primjene (manje od 1% doze dobivene iz urina).
English: Table 1 - Adverse reactions reported in patients treated with Xermelo System organ class
Croatian: Tablica 1 - Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika liječenih Xermelom Organski sustav
English: Ipsen Pharmaceuticals Ltd. Blanchardstown Industrial Park Blanchardstown IRL-Dublin 15
Croatian: Blanchardstown Industrial Park Blanchardstown IRL-Dublin 15
English: The renal clearance of telotristat was 0.126 L/h.
Croatian: Bubrežni klirens telotristata bio je 0,126 l/h.
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.
Croatian: Ova ispitivanja potvrdila su da telotristat nije povećao incidenciju tumora u obje vrste i oba spola pri dozama koje su u miševa odgovarale izloženosti od približno 10 do 15 puta a u štakora približno 2 do 4,5 puta izloženosti aktivnom metabolitu u ljudi pri MRHD-u.
English: After oral administration to healthy volunteers, telotristat ethyl was rapidly absorbed, and almost completely converted to its active metabolite.
Croatian: Nakon peroralne primjene u zdravih dobrovoljaca, etiltelotristat se brzo apsorbirao i gotovo potpuno pretvorio u svoj aktivni metabolit.
English: Depression, depressed mood
Croatian: Psihijatrijski poremećaji depresija, depresivno raspoloženje
English: The long-term safety and tolerability of telotristat was evaluated in a nonpivotal (nonrandomized), phase 3, multicentre, open-label, long-term extension study.
Croatian: Dugoročna sigurnost i podnošljivost telotristata procijenjena je u nepivotalnom (nerandomiziranom) multicentričnom, otvorenom dugoročnom nastavku ispitivanja faze 3.
English: Depressive disorders
Croatian: Depresivni poremećaji
English: What Xermelo is and what it is used for 2.
Croatian: Što je Xermelo i za što se koristi 2.
English: This medicine is used in adults with a condition called ‘carcinoid syndrome'.
Croatian: Ovaj lijek se primjenjuje u odraslih osoba s „karcinoidnim sindrom”.
English: Distribution Both telotristat ethyl and its active metabolite are > 99% bound to human plasma proteins.
Croatian: Distribucija Etiltelotristat, kao i njegov aktivni metabolit, vezani su na proteine ljudske plazme > 99%.
English: This is when a tumour, called a ‘neuroendocrine tumour', releases a substance called serotonin into your bloodstream.
Croatian: To je stanje u kojem tumor koji se naziva „neuroendokrini tumor“ otpušta u krvotok tvar koja se naziva serotonin.
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).
Croatian: • fekalna impakcija (začepljenje crijeva, fekalom), možete iskusiti zatvor, vodeni proljev, blijedu koža (anemija), mučninu, povraćanje, gubitak težine, bol u leđima ili bolove u trbuhu, posebno nakon jela ili smanjeni prolaz vode (mokrenje).
English: • medicines used to avoid transplant rejection, such as cyclosporine.
Croatian: • lijekove koji se uzimaju kako bi se spriječilo odbacivanje transplantiranog organa, kao što je ciklosporin
English: This is because this medicine has not been tested in patients with end-stage kidney disease, requiring dialysis.
Croatian: To je zbog toga što ovaj lijek nije ispitan u bolesnika s bolešću bubrega u završnom stadiju, koja zahtijeva dijalizu.
English: Study week
Croatian: Tjedan ispitivanja
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).
Croatian: • Drugi sastojci su: bezvodna laktoza (vidjeti dio 2 pod naslovom „Xermelo sadrži laktozu”), hidroksipropilceluloza, umrežena karmelozanatrij, magnezijev stearat, koloidni bezvodni silicijev dioksid, poli(vinilni alkohol) (djelomično hidroliziran) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521) i talk (E553b).
English: No studies on the effect of telotristat on human fertility have been conducted.
Croatian: Nisu provedena ispitivanja o učinku telotristata na plodnost u ljudi.
English: At doses of 200 and 500 mg/kg/day degeneration/necrosis in the nonglandular and/or glandular portions of the stomach and/or increased protein droplets in the glandular portions were observed.
Croatian: Pri dozama od 200 i 500 mg/kg na dan opažene su degeneracija/nekroza u nežljezdanim i/ili žljezdanim dijelovima želuca i/ili povećane kapljice proteina u žljezdanim dijelovima.
English: It will reduce your diarrhoea.
Croatian: To će smanjiti proljev.
English: On the basis of the scientific conclusions for telotristat the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing telotristat is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za telotristat, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) telotristat nepromijenjen, uz predložene izmjene informacija o lijeku.
English: If you have liver problems, your doctor may decide to reduce your daily dose of Xermelo.
Croatian: Ako imate tegoba s jetrom, liječnik može odlučiti da Vam treba sniziti dnevnu dozu lijeka Xermelo.
English: Note: This figure plots the arithmetic mean and 95% confidence limits (CL) (based on normal approximation) of the change from Baseline in the number of daily bowel movements (counts/day) averaged at each week.
Croatian: Napomena: Slika prikazuje arimetičku sredinu i 95%-tne granice pouzdanosti (na temelju normalne aproksimacije) za promjene u broju dnevnih pražnjenja crijeva (broj/dan) uprosječene za svaki tjedan.
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B
Croatian: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B 1495 - 190 Algés
English: In vitro, telotristat ethyl inhibited CES2 with an IC50 approximately of 6.4 μM.
Croatian: Etiltelotristat inhibirao je in vitro CES2 uz IC50 od približno 6,4 μM.
English: Eight subjects with severe to moderate renal impairment not requiring dialysis [eGFR ≤ 33 mL/min at screening and ≤40 mL/min at the day prior to dosing] and eight healthy to mildly impaired subjects [eGFR ≥88 mL/min at screening and ≥83 mL/min at the day prior to dosing] were included in this study.
Croatian: Osam ispitanika s teškim do umjerenim oštećenjem funkcije bubrega koji ne zahtijevaju dijalizu [eGFR ≤ 33 ml/min na probiru i ≤ 40 ml/min na dan prije doziranja] i osam ispitanika koji su bili zdravi ili imali blago oštećenje funkcije bubrega [eGFR ≥ 88 ml/min na probiru i ≥ 83 ml/min na dan prije doziranja] uključeni su u ovo ispitivanje.
English: Telotristat had no effect on fertility in animal studies (see section 5.3).
Croatian: Telotristat nije imao učinka na plodnost u ispitivanjima na životinjama (vidjeti dio 5.3).
English: • medicines used to treat your neuroendocrine tumour, such as sunitinib or everolimus.
Croatian: • lijekove kojima se liječi neuroendokrini tumor, kao što su sunitinib ili everolimus
English: • if you feel down, depressed, or if you feel you have no interest or take any pleasure in doing your normal activities, whilst taking this medicine
Croatian: • ako tijekom uzimanja lijeka primijetite da se osjećate potišteno, depresivno ili ako osjećate da ste izgubili zanimanje za svoje uobičajene aktivnosti ili Vam one ne pričinjavaju zadovoljstvo
English: The mean age was 64 years (range 37 to 88 years), 52% were male and 90% were white.
Croatian: Srednja vrijednost dobi bila je 64 godine (raspon od 37 do 88 godina), 52% bolesnika bili su muškarci a 90% bijelci.
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).
Croatian: Etiltelotristat je in vitro inhibirao BCRP (IC50 = 20 µM), ali njegov aktivni metabolit telotristat nije pokazao nikakvu značajnu inhibiciju aktivnosti BCRP-a (IC50 > 30 µM).
English: A high variability (% CV range of 18% to 99%) in telotristat ethyl and its active metabolite parameters was observed within the overall PK.
Croatian: Velika varijabilnost (raspon koeficijenta varijacije [% CV] od 18% do 99%) parametara etiltelotristata i njegova aktivnog metabolita opažena je unutar cjelokupne farmakokinetike.
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).
Croatian: Primjena telotristata ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh stadij C) jer nema dostupnih podataka (vidjeti dio 5.2).
English: - if you are allergic to telotristat or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Xermelo: - ako ste alergični na telotristat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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).
Croatian: Telotristat (aktivni metabolit) prouzročio je in vitro povećanje razina CYP2B6 mRNK ovisno o koncentraciji (povećanje > 2 puta i > 20% pozitivne kontrole s najvećim opaženim učinkom sličnim onom u pozitivne kontrole), što ukazuje na moguću indukciju CYP2B6 (vidjeti dio 4.5).
English: You should not breast-feed if you are taking Xermelo, as this medicine may be passed on to your baby.
Croatian: Ne smijete dojiti ako uzimate Xermelo, jer lijek može preko mlijeka dospjeti u dijete.
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.
Croatian: Srednje vrijednosti farmakokinetičkih parametara za etiltelotristat i njegov aktivni metabolit pokazale su se nepromijenjenima između 24. i 48. tjedna, što ukazuje na to da je stanje dinamičke ravnoteže dosegnuto u 24. tjednu ili prije toga.
English: Xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
Croatian: Xermelo je indiciran za liječenje proljeva kod karcinoidnog sindroma u kombinaciji s terapijom analogom somatostatina (engl. somatostatin analogue, SSA) u odraslih osoba u kojih proljev nije odgovarajuće kontroliran terapijom SSA-om.
English: Cartons of 90 and 180 tablets.
Croatian: Kutije s 90 i 180 tableta.
English: b. Statistical tests used a blocked 2-sample Wilcoxon Rank Sum statistic (van Elteren test) stratified by the u5-HIAA stratification at randomization.
Croatian: b. U statističkim testovima koristio se Wilcoxonov test sume rangova s blokovima u dva uzorka (van Elterenov test) stratificirana prema u5-HIAA stratifikaciji na randomizaciji.
English: Carboxylesterases
Croatian: Karboksilesteraze
English: Via del Bosco Rinnovato n. 6 Milanofiori Nord Palazzo U7 20090 Assago (MI) Tel: + 39 - 02 - 39 22 41
Croatian: 6 Milanofiori Nord Palazzo U7 20090 Assago (MI) Tel: + 39 - 02 - 39 22 41
English: Effect of other medicinal products on Xermelo
Croatian: Učinak drugih lijekova na Xermelo
English: • medicines for diarrhoea.
Croatian: • lijekove protiv proljeva.
English: This is because this medicine has not been tested in patients with severe liver problems.
Croatian: To je zbog toga što ovaj lijek nije ispitan u bolesnika s teškim tegobama s jetrom.
English: The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%).
Croatian: Najčešće nuspojave zabilježene u bolesnika liječenih telotristatom bile su bol u abdomenu (26%), povišena gama-glutamil transferaza (11%) i umor (10%).
English: Each tablet is approximately 17 mm long by 7.5 mm wide with ‘T-E' debossed on one side and ‘250' debossed on the other.
Croatian: Svaka tableta duga je približno 17 mm, a široka 7,5 mm, s oznakom „T-E” otisnutom na jednoj strani i „250” na drugoj.
English: BEAUFOUR IPSEN INDUSTRIE RUE ETHE VIRTON DREUX
Croatian: IPSEN INDUSTRIE RUE ETHE VIRTON DREUX
English: Carboxylesterase (CES) inhibitors
Croatian: Inhibitori karboksilesteraze (CES)
English: Relevance of these gastrointestinal findings to humans is unknown.
Croatian: Važnost tih nalaza s obzirom na probavni sustav za ljude nije poznata.
English: There is limited clinical experience with telotristat overdose in humans.
Croatian: Kliničko je iskustvo s predoziranjem telotristatom u ljudi ograničeno.
English: No change in dosage is required in patients with mild, moderate or severe renal impairment; who are not requiring dialysis (see section 5.2).
Croatian: Nije potrebna promjena u doziranju u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega; koji ne zahtijevaju dijalizu (vidjeti dio 5.2).
English: 90 film-coated tablets 180 film-coated tablets
Croatian: OBLIK I SADRŽAJ 90 filmom obloženih tableta 180 filmom obloženih tableta
English: The most frequently reported adverse reaction leading to discontinuation of telotristat was abdominal pain in 7.1% of patients (5/70).
Croatian: Najčešće zabilježena nuspojava koja je dovela do prekida primjene telotristata bila je bol u abdomenu u 7,1% bolesnika (5/70).
English: There is no relevant use of telotristat in the paediatric population in the indication of carcinoid syndrome.
Croatian: Pedijatrijska populacija Nema relevantne primjene telotristata u pedijatrijskoj populaciji za indikaciju karcinoidnog sindroma.
English: All patients had well-differentiated metastatic neuroendocrine tumours and carcinoid syndrome.
Croatian: Svi su bolesnici imali dobro diferencirane metastatske neuroendokrine tumore i karcinoidni sindrom.
English: This medicine contains the active substance telotristat ethyl.
Croatian: Ovaj lijek sadrži djelatnu tvar etiltelotristat.
English: Effect of Xermelo on other medicinal products
Croatian: Učinak lijeka Xermelo na druge lijekove
English: In patients with carcinoid syndrome, telotristat resulted in reductions in u5-HIAA (refer to Table 3 for TELESTAR and information provided for TELECAST).
Croatian: U bolesnika s karcinoidnim sindromom, telotristat je rezultirao smanjenjem razine u5-HIAA (vidjeti tablicu 3 za ispitivanje TELESTAR i podatke ispitivanja TELECAST).
English: Xermelo contains lactose
Croatian: Xermelo sadrži laktozu
English: In vitro, telotristat ethyl inhibited CYP3A4, suggesting a potential interaction with CYP3A4 substrates.
Croatian: Etiltelotristat je in vitro inhibirao CYP3A4, što upućuje na potencijalnu interakciju sa supstratima CYP3A4.
English: In the event of a missed dose, patients should take their subsequent dose at the next scheduled time point.
Croatian: U slučaju da bolesnik propusti dozu, sljedeću dozu treba uzeti prema uobičajenom rasporedu.
English: CLs were based on the HodgesLehmann estimator of the median paired difference.
Croatian: Vrijednosti granica pouzdanosti (CL) temeljile su se na Hodges-Lehmannovoj procjeni razlike uparenih medijana.
English: Your doctor may decide to decrease your daily dose of Xermelo.
Croatian: Liječnik će možda odlučiti da Vam treba smanjiti dnevnu dozu lijeka Xermelo.
English: As a precautionary measure, it is recommended that patients with severe renal impairment will be monitored for signs of reduced tolerability.
Croatian: Kao mjera opreza, preporučuje se da se bolesnici s teškim oštećenjem bubrega prate na znakove smanjene podnošljivosti.
English: Number of patients Change averaged over 12 weeks: mean (SD)
Croatian: Promjena uprosječena za 12 tjedana: srednja vrijednost (SD)
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.
Croatian: S obzirom na veliku promatranu varijabilnost, preporučuje se kao mjera opreza da se bolesnici s teškim oštećenjem funkcije bubrega prate na znakove smanjene podnošljivosti.