FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Bele do umazanobele filmsko obložene, ovalne tablete (približno 17 mm dolge in 7,5 mm široke) z vtisnjeno oznako ‘T-E' na eni in ‘250' na drugi strani.
English: Lactose anhydrous Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Silica, colloidal anydrous
Slovenian: Jedro tablete brezvodna laktoza hidroksipropilceluloza premreženi natrijev karmelozat magnezijev stearat koloidni brezvodni silicijev dioksid
English: Carboxylesterases
Slovenian: Karboksilesteraze
English: Cartons of 90 and 180 tablets.
Slovenian: Na voljo so škatle z 90 in 180 tabletami.
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).
Slovenian: V 12-tedenskem obdobju dvojno slepega zdravljenja v študiji je bilo povprečno tedensko zmanjšanje pogostnosti odvajanja blata pri uporabi telotristata opaženo že po 3 tednih, največje zmanjšanje pa je bilo doseženo v zadnjih 6 tednih dvojno slepega zdravljenja v primerjavi s placebom (glejte sliko 1).
English: You should not take this medicine if you are pregnant or might become pregnant.
Slovenian: Če ste noseči ali bi lahko bili noseči, tega zdravila ne smete jemati.
English: Percent change from baseline in u5-HIAA excretion (mg/24 hours) at week 12
Slovenian: Odstotna sprememba od izhodišča pri izločanju u5-HIAA (mg/24 ur) v 12. tednu
English: Since telotristat ethyl is rapidly converted to its active metabolite, which is > 25× more active than telotristat ethyl, no dose adjustments are required when using Xermelo with acid reducers.
Slovenian: Ker se etiltelotristat hitro pretvori v aktivni presnovek, katerega aktivnost je za več kot 25-krat večja od aktivnosti etiltelotristata, pri sočasni uporabi zdravila Xermelo in zdravil za zmanjševanje kislosti želodčnega soka odmerka ni treba prilagajati.
English: • medicines for diarrhoea.
Slovenian: • zdravili za zdravljenje driske.
English: During the study, patients were allowed to use rescue medication (short-acting SSA therapy) and anti-diarrhoeals for symptomatic relief but were required to be on stable-dose long-acting SSA therapy for the duration of the DBT period.
Slovenian: Med študijo so bolniki lahko uporabljali rešilno zdravilo (kratkodelujoči analog somatostatina) in antidiaroike za lajšanje simptomov, vendar pa so se ves čas trajanja dvojno slepega obdobja zdravljenja morali zdraviti s stabilnim odmerkom dolgodelujočega analoga somatostatina.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for telotristat, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za telotristat je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: In patients with carcinoid syndrome on long-acting SSA therapy, there was also a rapid conversion of telotristat ethyl to its active metabolite.
Slovenian: Pri bolnikih s karcinoidnim sindromom, ki so se zdravili z dolgodelujočim analogom somatostatina, je bila pretvorba etiltelotristata v njegov aktivni presnovek prav tako hitra.
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.
Slovenian: Odstotna sprememba od izhodišča v izločanju u5-HIAA v 12. tednu je v skupini s placebom znašala +97,7 % v primerjavi z -33,2 % v skupini z odmerkom 250 mg.
English: In an in vivo clinical drug-drug interaction (DDI) study with midazolam (a sensitive CYP3A4 substrate), following administration of multiple doses of telotristat ethyl, the systemic exposure to concomitant midazolam was significantly decreased (see section 4.5).
Slovenian: V in vivo klinični študiji medsebojnega delovanja med zdravili z midazolamom (občutljivim substratom za CYP3A4) se je po uporabi večkratnih odmerkov etiltelotristata sistemska izpostavljenost sočasno uporabljenemu midazolamu pomembno zmanjšala (glejte poglavje 4.5).
English: If you forget to take Xermelo
Slovenian: Če ste pozabili vzeti zdravilo Xermelo
English: It will reduce your diarrhoea.
Slovenian: Tako ublaži vašo drisko.
English: If you stop taking Xermelo
Slovenian: Če ste prenehali jemati zdravilo Xermelo
English: Ipsen Pharma România SRL Sectorul 1, Strada Grigore Alexandrescu nr. 59, Etaj 1
Slovenian: Sectorul 1, Strada Grigore Alexandrescu nr. 59,
English: • Swollen stomach
Slovenian: • oteklost trebuha
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.
Slovenian: Pri bolnikih z zmerno okvaro jeter (ocena B po Child Pugh) bo odmerek, glede na prenašanje zdravila, morda treba zmanjšati na 250 mg enkrat na dan.
English: Patients should not breast-feed during telotristat treatment.
Slovenian: Bolnice med zdravljenjem s telotristatom ne smejo dojiti.
English: Short acting octreotide
Slovenian: Kratkodelujoči oktreotid
English: This medicine is used in adults with a condition called ‘carcinoid syndrome'.
Slovenian: Za kaj uporabljamo zdravilo Xermelo To zdravilo uporabljamo pri odraslih s stanjem, imenovanim ‘karcinoidni sindrom'.
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.
Slovenian: Delež bolnikov, ki so bili “zelo zadovoljni”, je pri uporabi placeba znašal 0/9 (0 %), pri uporabi etiltelotristata v odmerku 250 mg trikrat na dan 5/9 (56 %), pri uporabi višjega odmerka etiltelotristata pa 7/15 (47 %).
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.
Slovenian: Pri sočasni uporabi telotristatijevega etiprata (zdravilo Xermelo, etiltelotristat hipurat) in zdravil za zmanjševanje kislosti želodčnega soka (omeprazol in famotidin) se je vrednost AUC etiltelotristata povečala za 2- do 3-krat, vrednost AUC aktivnega presnovka (telotristat) pa se pri tem ni spremenila.
English: In a food effect study administration of telotristat ethyl 500 mg with a high-fat meal resulted in higher exposure to the parent compound (Cmax, AUC0-tlast, and AUC0-∞ being 112%, 272%, and 264% higher, respectively compared with the fasted state) and its active metabolite (Cmax, AUC0-tlast, and AUC0-∞, 47%, 32%, and 33% higher, respectively compared with the fasted state).
Slovenian: V študiji vpliva hrane je bila pri uporabi etiltelotristata v odmerku 500 mg skupaj s hrano z veliko vsebnostjo maščob, izpostavljenost izvorni učinkovini večja (Cmax večja za 112 %, AUC0-tlast večja za 272 % in AUC0-∞ večja za 264 % v primerjavi z uporabo na tešče), prav tako pa tudi njenemu aktivnemu presnovku (Cmax večja za 47 %, AUC0-tlast večja za 32 % in AUC0-∞ večja za 33 % v primerjavi z uporabo na tešče).
English: Figure 1 - Mean change from baseline in BMs by study week during the DBT period, Intent-toTreat Population
Slovenian: Slika 1 - Povprečna sprememba od izhodišča pri odvajanju blata glede na teden študije med obdobjem dvojno slepega zdravljenja, vključena populacija (Intent-to-Treat Population)
English: Cytochromes
Slovenian: Citokromi
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.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
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.
Slovenian: V študiji pri bolnikih z okvaro jeter, izvedeni z enkratnim odmerkom 500 mg, je bila izpostavljenost izvorni učinkovini in njenemu aktivnemu presnovku (na osnovi AUC0-tlast) večja pri bolnikih z blago okvaro jeter (2,3-krat oziroma 2,4-krat) in pri bolnikih z zmerno okvaro jeter (3,2-krat oziroma 3,5-krat) v primerjavi z zdravimi osebami.
English: Telotristat may have a small effect on your ability to drive or use any tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Telotristat ima lahko blag vpliv na sposobnost upravljanja vozil, orodij ali strojev.
English: What Xermelo looks like and contents of the pack
Slovenian: Izgled zdravila Xermelo in vsebina pakiranja
English: Brain 5-HIAA levels were unchanged at all doses of telotristat ethyl examined.
Slovenian: Vrednosti 5-HIAA v možganih so pri vseh preiskovanih odmerkih etiltelotristata ostale nespremenjene.
English: Constipation was reported in patients using a higher dose (500 mg).
Slovenian: O večini primerov so poročali pri uporabi višjega odmerka (500 mg).
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Telotristat ima blag vpliv na sposobnost vožnje in upravljanja strojev.
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).
Slovenian: Najpogosteje poročani neželeni učinek pri bolnikih, ki so prejemali etiltelotristat v odmerku 250 mg trikrat na dan, je bila bolečina v trebuhu (25,7 %; 18/70) v primerjavi s placebom (19,7 %; 14/71).
English: Based on post marketing and clinical data it is recommended to update section 4.8 to include nausea as an adverse drug reaction in Section 4.8 under the SOC Gastrointestinal disorders with a frequency “very common”.
Slovenian: Na osnovi podatkov po prihodu zdravila na trg in kliničnih podatkov je priporočljivo posodobiti poglavje 4.8 tako, da se pod organski sistem Bolezni prebavil doda neželeni učinek navzea z navedbo pogostnosti “zelo pogosti”.
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.
Slovenian: V študijah 1. faze je uporaba etiltelotristata pri zdravih osebah (razpon odmerkov: 100 mg enkrat na dan do 500 mg trikrat na dan) povzročila statistično pomembno zmanjšanje vrednosti serotonina v polni krvi in 24-urne vrednosti 5-hidroksiindolocetne kisline v urinu (u5-HIAA; “urinary 5hydroxyindoleacetic acid”) od izhodišča v primerjavi s placebom.
English: Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes tested and telotristat should be discontinued if liver injury is suspected.
Slovenian: Pri bolnikih s simptomi, ki kažejo na motnje delovanja jeter, je treba opraviti preiskave vrednosti jetrnih encimov in v primeru suma na okvaro delovanja jeter zdravljenje s telotristatom prekiniti.
English: Faecalomac, intestinal obstruction
Slovenian: flatulenca fekalna impakcija (fekalom)c, intestinalna obstrukcija
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.
Slovenian: Zdravilo Xermelo je v kombinaciji z analogom somatostatina indicirano za zdravljenje diareje zaradi karcinoidnega sindroma pri odraslih, nezadostno nadzorovanih samo z zdravljenjem z analogom somatostatina.
English: Patients should not take a double dose to make up for a missed dose.
Slovenian: Bolnik ne sme vzeti dvojnega odmerka, če je pozabil vzeti prejšnji odmerek.
English: What you need to know before you take Xermelo 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xermelo
English: The most commonly reported adverse reactions in patients treated with telotristat were abdominal pain (26%), gamma-glutamyl transferase increased (11%) and fatigue (10%).
Slovenian: bolečina v trebuhu (26 %), zvišane vrednosti gama-glutamiltransferaze (11 %) in utrujenost (10 %).
English: Serious constipation was observed in 3 patients treated with a higher dose (500 mg) in the overall safety population (239 patients).
Slovenian: V celotni populaciji bolnikov z ocenjeno varnostjo (239 bolnikov) so o resnem zaprtju poročali pri 3 bolnikih, ki so se zdravili z višjim odmerkom (500 mg).
English: Package leaflet: Information for the patient Xermelo 250 mg film-coated tablets telotristat ethyl This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Xermelo 250 mg filmsko obložene tablete etiltelotristat Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Telotristat ethyl and telotristat have a low renal elimination following oral administration (less than 1% of the dose recovered from the urine).
Slovenian: Po peroralni uporabi se etiltelotristat in telotristat v majhnem obsegu izločata skozi ledvice (z urinom se izloči manj kot 1 % odmerka).
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).
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro ledvic, ki ne potrebujejo zdravljenja z dializo, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Number of Patients Percent Change at Week 12: Mean (SD) Estimate of Treatment Difference (95% CL)b
Slovenian: (SD) Ocena razlike zdravljenja (95 % IZ)b
English: Selise 26 - 11
Slovenian: CentralPharma Communications OÜ Selise 26 - 11
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.
Slovenian: Glede na opaženo veliko variabilnost je bolnike s hudo okvaro ledvic iz previdnostnih razlogov priporočljivo spremljati glede pojava znakov slabšega prenašanja zdravila.
English: Following a single oral 250 mg dose of telotristat ethyl to heathy volunteers, urine concentrations of telotristat ethyl were close to or below the limit of quantification (<0.1 ng/mL).
Slovenian: Pri zdravih prostovoljcih so bile po enkratnem 250-mg peroralnem odmerku etiltelotristata koncentracije etiltelotristata v urinu blizu meje kvantifikacije (< 0,1 ng/ml) ali pod njo.
English: Torre Realia, Plaza de Europa, 41-43 08908 L'Hospitalet de Llobregat Barcelona
Slovenian: Torre Realia, Plaza de Europa, 41-43
English: In vitro loperamide (CES2 inhibitor) had a moderate effect on the metabolism of telotristat ethyl, reducing the formation of telotristat by <30% (see section 4.5).
Slovenian: Loperamid (zaviralec CES2) je in vitro zmerno vplival na presnovo etiltelotristata, in sicer je zmanjšal tvorbo telotristata za < 30 % (glejte poglavje 4.5).
English: • You should keep having injections of somatostatin analogues (lanreotide or octreotide) when taking
Slovenian: • Med jemanjem zdravila Xermelo morate še naprej prejemati injekcije analogov somatostatina (lanreotid ali oktreotid).
English: Loperamide caused a <30% decrease in the formation of telotristat (active metabolite) in vitro (see section 5.2).
Slovenian: Loperamid je in vitro za < 30 % zmanjšal tvorbo telotristata (aktivnega presnovka) (glejte poglavje 5.2).
English: Tel: +371 67622233
Slovenian: LV 1046 Tel: +371 67622233
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).
Slovenian: Povprečno število dnevnih odvajanj blata v izhodišču je v skupini s placebom (n=25) znašalo 2,2, v skupini z odmerkom 250 mg (n=25) pa 2,5.
English: Xermelo contains lactose
Slovenian: Zdravilo Xermelo vsebuje laktozo
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).
Slovenian: aplicirani v razmiku 8 ur) na farmakokinetiko enkratnega odmerka zdravila Xermelo pri zdravih prostovoljcih, je pokazala zmanjšanje vrednosti Cmax in AUC etiltelotristata za 83 %, vrednosti Cmax in AUC telotristata pa za 81 % (glejte poglavje 4.5).
English: Concomitant administration of short-acting octreotide with Xermelo significantly decreased the systemic exposure of telotristat ethyl and telotristat, the active metabolite (see section 5.2).
Slovenian: Pri sočasni uporabi kratkodelujočega oktreotida in zdravila Xermelo se lahko pomembno zmanjša sistemska izpostavljenost etiltelotristata in njegovega aktivnega presnovka telotristata (glejte poglavje 5.2).
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.
Slovenian: Če je potrebno zdravljenje s kratkodelujočim oktreotidom v kombinaciji z zdravilom Xermelo, je treba kratkodelujoči oktreotid aplicirati vsaj 30 minut po dajanju zdravila Xermelo.
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).
Slovenian: V kliničnih preskušanjih in v obdobju trženja zdravila so pri nekaterih bolnikih, ki so prejemali telotristat, poročali o pojavu depresije, depresivnega razpoloženja in zmanjšanju zanimanja (glejte poglavje 4.8).
English: A pre-specified patient exit interview substudy was conducted to assess relevance and clinical meaningfulness of symptom improvements in 35 patients.
Slovenian: Za ovrednotenje pomena in klinične smiselnosti izboljšanja simptomov je bila izvedena vnaprej določena podštudija v obliki intervjuja s 35 bolniki ob končanju študije.
English: • Belly (abdominal) pain
Slovenian: • bolečina v trebuhu (abdomnu)
English: The mean Cmax, and AUC0-inf for the active metabolite, 1'-hydroxymidazolam, were also decreased by 34%, and 48%, respectively.
Slovenian: 1'-hidroksimidazolama, in sicer za 34 %, vrednost AUC0-inf pa za 48 %.
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).
Slovenian: Pri sočasni uporabi zdravila Xermelo se lahko zmanjša učinkovitost zdravil, ki so substrati za CYP3A4 (npr. midazolam, everolimus, sunitinib, simvastatin, etinilestradiol, amlodipin,
English: Adverse reactions reported in a pooled safety dataset of 70 patients with carcinoid syndrome receiving telotristat ethyl 250 mg tid in combination with SSA therapy in placebo-controlled clinical trials are listed in Table 1.
Slovenian: V preglednici 1 so navedeni neželeni učinki iz združene podatkovne baze varnosti pri 70 bolnikih s karcinoidnim sindromom, ki so prejemali etiltelotristat v odmerku 250 mg trikrat na dan v kombinaciji z analogom somatostatina v s placebom nadzorovanih kliničnih preskušanjih.
English: Telotristat ethyl and its active metabolite were not shown to be inducers of CYP3A4 at systemically relevant concentrations, based on in vitro findings.
Slovenian: In vitro izsledki ne kažejo, da bi bila etiltelotristat in njegov aktivni presnovek induktorja CYP3A4 pri sistemsko pomembnih koncentracijah.
English: There were 40% patients (10/25) with durable response (as defined in Table2) in the telotristat ethyl 250 mg group, versus 0% in the placebo group (0/26) (p=0.001).
Slovenian: V skupini z etiltelotristatom v odmerku 250 mg je bilo 40 % bolnikov (10/25) s trajnim odzivom (kot je opredeljen v preglednici 2) v primerjavi z 0 % v skupini s placebom (0/26) (p=0,001).
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.
Slovenian: Pri bolnikih z blago okvaro jeter (ocena A po Child Pugh) bo odmerek, glede na prenašanje zdravila, morda treba zmanjšati na 250 mg dvakrat na dan.
English: • feeling or being sick (unexplained nausea or vomiting), abnormally dark urine, yellow skin or eyes,
Slovenian: • siljenje na bruhanje ali bruhanje (nepojasnjena navzea ali bruhanje), nenormalno temen urin,
English: When 3 mg midazolam was coadministered orally after 5-day treatment with telotristat ethyl 500 mg tid (twice the recommended dose), the mean Cmax, and AUC0-inf for midazolam were decreased by 25%, and 48%, respectively, compared with administration of midazolam alone.
Slovenian: Pri sočasni uporabi midazolama v odmerku 3 mg peroralno po 5-dnevnem zdravljenju z etiltelotristatom v odmerku 500 mg trikrat na dan (dvakratni priporočeni odmerek) se je povprečna vrednost Cmax midazolama zmanjšala za 25 %, vrednost AUC0-inf midazolama pa za 48 % v primerjavi z uporabo midazolama samega.
English: The change from baseline in daily BM averaged over 12 weeks was +0.1 and -0.5 in the placebo and 250 mg groups respectively.
Slovenian: Povprečna sprememba od izhodišča pri dnevnem odvajanju blata v 12 tednih je v skupini s placebom znašala +0,1, v skupini z odmerkom 250 mg pa -0,5.
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.
Slovenian: Pri psih je bilo zmanjšanje vrednosti 5-HT v možganih opaženo pri peroralni uporabi telotristatijevega etiprata v odmerku 200 mg/kg/dan, zmanjšanje vrednosti 5-HIAA pa pri peroralni uporabi telotristatijevega etiprata v odmerku 30 mg/kg/dan.
English: The mean Cmax and AUC0-inf were 610 ng/mL and 2320 ng•hr/mL, respectively for telotristat.
Slovenian: Za telotristat je bila povprečna vrednost Cmax 610 ng/ml, vrednost AUC0-inf pa 2.320 ng•hr/ml.
English: It is recommended to reassess the benefit of continued therapy in a patient not responding within this time period.
Slovenian: Pri bolnikih brez doseženega odziva v tem časovnem obdobju je korist nadaljnjega zdravljenja priporočljivo znova ovrednotiti.
English: Oedema peripheral, Pyrexia a Abdominal pain (including upper and lower abdominal pain) b Gamma-glutamyl transferase increased (including preferred terms of gamma-glutamyl transferase increased, gamma-glutamyl transferase, and liver function test abnormal / hepatic enzyme increased for which gamma-glutamyl transferase was increased).
Slovenian: b Zvišane vrednosti gama-glutamiltransferaze (vključuje izraze: zvišane vrednosti gama glutamiltransferaze, nenormalne vrednosti gama-glutamiltransferaze in nenormalne izvide preiskav delovanja jeter/zvišane vrednosti jetrnih encimov, pri katerih je bilo ugotovljeno zvišanje vrednosti gama-glutamiltransferaze).
English: As a precautionary measure, it is recommended that patients with severe renal impairment will be monitored for signs of reduced tolerability.
Slovenian: Iz previdnostnih razlogov je bolnike s hudo okvaro ledvic priporočljivo spremljati glede pojava znakov slabšega prenašanja zdravila.
English: What you need to know before you take Xermelo Do not take Xermelo:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Xermelo Kako jemati zdravilo Xermelo
English: Xermelo 250 mg film-coated tablets
Slovenian: IME ZDRAVILA Xermelo 250 mg filmsko obložene tablete