FrancophonIA/ELRC3.0 huggingface dataset:
English: The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug interaction study in healthy volunteers.
Slovenian: Predvidene farmakokinetične interakcije, ki bi lahko vplivale na pasireotid Učinek verapamila, ki je zaviralec P-gp (P-glikoproteina), na farmakokinetiko subkutano apliciranega pasireotida so preverjali v študiji medsebojnega delovanja zdravil na zdravih prostovoljcih.
English: Reductions in serum cortisol and plasma ACTH levels were also observed at month 7 and 12 for each dose group.
Slovenian: Po 7 in 12 mesecih so pri obeh odmernih skupinah opažali tudi znižanje vrednosti kortizola v serumu in ACTH v plazmi.
English: No studies have been conducted to evaluate the bioavailability of pasireotide in humans.
Slovenian: Študij za vrednotenje biološke uporabnosti pasireotida pri ljudeh niso izvajali.
English: Two-thirds of all patients had undergone prior surgery.
Slovenian: Dve tretjini bolnikov sta predhodno že prestali kirurški poseg.
English: The reactions were most frequently reported as local pain, erythema, haematoma, haemorrhage and pruritus.
Slovenian: Reakcije so najbolj pogosto opisovali kot lokalno bolečino, rdečino, hematom, krvavitev ali srbenje.
English: The primary efficacy end point was the proportion of patients in each arm who achieved mean 24-hour UFC levels ≤ULN after 7 months of treatment, regardless of prior dose increase.
Slovenian: Primarni cilj opazovanja učinkovitosti je bil v vsaki skupini delež bolnikov, ki so po 7 mesecih zdravljenja dosegli povprečno 24-urno vrednost UFC v višini največ ZMN ne glede na predhodno zviševanje odmerka.
English: Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also section 4.4).
Slovenian: Pasireotid je treba uporabljati previdno pri bolnikih, ki sočasno prejemajo zdravila, ki podaljšujejo interval QT, kot so antiaritmiki razreda Ia (na primer kinidin, prokainamid, dizopiramid), antiaritmiki razreda III (na primer amiodaron, dronedaron, sotalol, dofetilid, ibutilid), določeni antibiotiki (intravenski eritromicin, injekcija pentamidina, klaritromicin, moksifloksacin), določeni antipsihotiki (na primer klorpromazin, tioridazin, flufenazin, pimozid, haloperidol, tiaprid, amisulprid, sertindol, metadon), določeni antihistaminiki (na primer terfenadin, astemizol, mizolastin), antimalariki (na primer klorokin, halofantrin, lumefantrin), določeni antimikotiki (ketokonazol, z izjemo ketokonazola v šamponu) (glejte tudi poglavje 4.4).
English: Patients should receive instructions from the physician or a healthcare professional on how to inject Signifor subcutaneously.
Slovenian: Zdravnik ali drug zdravstveni strokovnjak mora bolnika poučiti, kako naj si subkutano injicira zdravilo Signifor.
English: Patients were randomised in a 1:1 ratio to a starting dose of either 10 mg or 30 mg pasireotide intramuscular use every 4 weeks.
Slovenian: Bolnike so randomizirali v razmerju 1:1 na prejemanje začetnega odmerka bodisi 10 mg ali 30 mg pasireotida za intramuskularno uporabo vsake 4 tedne.
English: Cushing's disease is caused by an enlargement in the pituitary gland (a gland at the base of the brain) called a pituitary adenoma.
Slovenian: Cushingovo bolezen povzroča povečanje hipofize (žleze na spodnji strani možganov), kar imenujemo adenom hipofize.
English: Baseline characteristics were balanced between the two randomised dose groups, except for marked differences in the mean value of baseline 24-hour UFC (1156 nmol/24 h for the 0.6 mg twice daily group and 782 nmol/24 h for the 0.9 mg twice daily group; normal range 30-145 nmol/24 h).
Slovenian: Izhodiščne značilnosti bolnikov so bile v obeh randomiziranih skupinah enakomerno razporejene, z izjemo bistvene razlike pri povprečju izhodiščne 24-urne vrednosti UFC (1156 nmol/24 h v skupini z odmerkom 0,6 mg dvakrat na dan in 782 nmol/24 h v skupini z odmerkom 0,9 mg dvakrat na dan; pri čemer so normalne vrednosti 30-145 nmol/24 h).
English: It is unknown whether pasireotide is excreted in human milk.
Slovenian: Ni znano, ali se pasireotid izloča v materino mleko.
English: Hypocortisolism
Slovenian: Hipokortizolizem
English: The recommended dose is one ampoule of Signifor 0.6 mg twice a day.
Slovenian: Priporočeni odmerek je ena ampula zdravila Signifor 0,6 mg dvakrat na dan.
English: A dose increase to 0.9 mg may be considered based on the response to the treatment, as long as the 0.6 mg dose is well tolerated by the patient.
Slovenian: Glede na odziv na zdravljenje je mogoče odmerek zvišati na 0,9 mg, če bolnik dobro prenaša odmerek 0,6 mg.
English: Signifor should only be administered by a trained healthcare professional.
Slovenian: Zdravilo Signifor sme aplicirati samo usposobljen zdravstveni delavec.
English: Therapy with pasireotide should be discontinued if the patient develops jaundice or other signs suggestive of clinically significant liver dysfunction, in the event of a sustained increase in AST (aspartate aminotransferase) or ALT of 5 x ULN or greater, or if ALT or AST elevations greater than 3 x ULN occur concurrently with bilirubin elevations greater than 2 x ULN.
Slovenian: Zdravljenje s pasireotidom je treba prekiniti, če pride do ikterusa ali drugih znakov, ki nakazujejo klinično pomembno motnjo delovanja jeter, v primeru vztrajno zvišanih vrednosti AST (aspartat-aminotransferaze) ali ALT do 5kratnika ZMN ali več ali v primeru, da so sočasno zvišane vrednosti ALT ali AST nad 3-kratnik ZMN in vrednosti bilirubina nad 2-kratnik ZMN.
English: ATTENTION:
Slovenian: OPOZORILO:
English: Always keeping your skin pinched, slowly press the plunger down as far as it will go until all the solution is injected.
Slovenian: Medtem ko stiskate kožno gubo, počasi potiskajte bat navzdol, dokler gre in dokler niste injicirali raztopine v celoti.
English: Renal clearance has a minor contribution to the elimination of pasireotide in humans.
Slovenian: Izločanje preko ledvic pri človeku le malo prispeva k izločanju pasireotida.
English: Twelve months after crossover, the percentage of patients achieving biochemical control was 17.3% (14/81) for pasireotide intramuscular use and 0% (0/38) for octreotide intramuscular use.
Slovenian: Dvanajst mesecev po navzkrižni zamenjavi zdravila je biokemijsko urejenost bolezni doseglo 17,3 % bolnikov (14/81) v skupini z intramuskularno uporabo pasireotida in 0 % bolnikov (0/38) v skupini z intramuskularno uporabo oktreotida.
English: Each unit pack contains the vial and pre-filled syringe in a sealed blister tray with one vial adapter and one safety-engineered needle for injection.
Slovenian: Eno posamično pakiranje vsebuje vialo in napolnjeno injekcijsko brizgo v neprodušno zaprtem pretisnem omotu skupaj z enim adapterjem za vialo in eno varno oblikovano iglo za injiciranje.
English: At month 25, 48.6% of patients (36/74) in the pasireotide intramuscular use group and 45.7% (21/46) in the octreotide intramuscular use group achieved biochemical control.
Slovenian: Po 25 mesecih je biokemijsko urejenost bolezni doseglo 48,6 % bolnikov (36/74) v skupini z intramuskularno uporabo pasireotida in 45,7 % bolnikov (21/46) v skupini z intramuskularno uporabo oktreotida.
English: Additionally, tolerability and repeated dose toxicity studies were conducted with pasireotide via the intramuscular route.
Slovenian: Poleg tega so izvedli še študije prenosljivosti in toksičnosti pri ponavljajočih se odmerkih s pasireotidom za intramuskularno uporabo.
English: Multipacks (40 mg and 60 mg strengths only): each multipack contains 3 intermediate cartons, each containing a blister tray with one injection kit (one vial and, in a separate sealed section, one pre-filled syringe, one vial adapter and one safety engineered needle for injection).
Slovenian: Skupna pakiranja (samo jakosti 40 mg in 60 mg): eno skupno pakiranje vsebuje 3 vmesne škatle, od katerih vsaka vsebuje pretisni omot z enim kompletom za injiciranje (z eno vialo in eno napolnjeno injekcijsko brizgo v ločenem neprodušno zaprtem predelku, enim adapterjem za vialo in eno varno oblikovano iglo za injiciranje).
English: Prepare the injection site with an alcohol wipe.
Slovenian: Mesto injiciranja obrišite z alkoholno blazinico.
English: Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with Signifor (see section 4.6).
Slovenian: Bolnicam v rodni dobi je treba svetovati, naj v času zdravljenja z zdravilom Signifor uporabljajo primerno kontracepcijo, če je to potrebno (glejte poglavje 4.6).
English: In a pooled analysis of the two pivotal studies, the overall incidence of hyperglycaemia-related adverse reactions was 58.6% (all grades) and 9.9% (CTC Grade 3 and 4) for Signifor intramuscular use versus 18.0% (all grades) and 1.1% (CTC Grade 3 and 4) for the active control.
Slovenian: V analizi združenih podatkov dveh ključnih študij je skupna pogostnost vseh s hiperglikemijo povezanih neželenih učinkov znašala 58,6 % (za vse stopnje) oziroma 9,9 % (za stopnji 3 in 4 po kriterijih CTC) pri uporabi zdravila Signifor za intramuskularno uporabo v primerjavi z 18,0 % (za vse stopnje) oziroma 1,1 % (za stopnji 3 in 4 po kriterijih CTC) pri uporabi primerjalnega zdravila.
English: Single use.
Slovenian: za enkratno uporabo
English: Pasireotide should be used with caution and the benefit risk carefully weighed in patients who are at significant risk of developing prolongation of QT, such as those: - with congenital long QT syndrome.
Slovenian: Pasireotid je treba uporabljati previdno in skrbno pretehtati razmerje med koristmi in tveganji pri bolnikih, pri katerih obstaja pomembno tveganje za podaljšanje intervala QT, kot so bolniki: - s prirojenim sindromom dolgega intervala QT; - z neurejeno ali s pomembno boleznijo srca, kar vključuje nedavni miokardni infarkt,
English: Powder: brownish vial (glass) with rubber stopper (chlorobutyl rubber), containing the active substance (pasireotide).
Slovenian: Prašek: viala rjavkaste barve (steklena) z gumijasto zaporko (iz klorobutilne gume), ki vsebuje učinkovino (pasireotid).
English: Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue.
Slovenian: Zdravljenje odraslih bolnikov z akromegalijo, za katere kirurški poseg ni primeren oziroma pri katerih kirurški poseg ni odpravil bolezni, pri tem pa bolezen ni ustrezno urejena z zdravljenjem z drugim analogom somatostatina.
English: If such a switch should be required, the recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Slovenian: Če je takšna zamenjava potrebna, je priporočeni začetni odmerek za zdravljenje Cushingove bolezni 10 mg pasireotida z globoko intramuskularno injekcijo vsake 4 tedne.
English: In Cushing's disease patients, pasireotide demonstrates linear and time-independent pharmacokinetics in the dose range of 0.3 mg to 1.2 mg twice a day.
Slovenian: Farmakokinetika pasireotida je pri bolnikih s Cushingovo boleznijo v obsegu odmerkov od 0,3 mg do 1,2 mg dvakrat na dan linearna in neodvisna od časa.
English: One-point-cut colourless, type I glass ampoule containing 1 ml of solution.
Slovenian: Ampula z eno točko za prelom iz brezbarvnega stekla tipa I, ki vsebuje 1 ml raztopine.
English: The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete.
Slovenian: Relativna biološka uporabnost pasireotida za intramuskularno uporabo v celoti dosega biološko uporabnost pasireotida pri subkutani uporabi.
English: Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogues due to the association between cholelithiasis and acute pancreatitis.
Slovenian: Vnetje trebušne slinavke je možen neželeni učinek pri uporabi analogov somatostatina, in sicer zaradi povezave med holelitiazo in akutnim vnetjem trebušne slinavke.
English: Solvent: colourless pre-filled syringe (glass) with front and plunger stopper (chlorobutyl rubber), containing 2 ml solvent.
Slovenian: Vehikel: brezbarvna napolnjena injekcijska brizga (steklena) z batnim tesnilom in zaviralom (iz klorobutilne gume), ki vsebuje 2 ml vehikla.
English: Patients were randomised in a 1:1 ratio to one of two treatment groups in each of the following two strata: 1) patients who had undergone one or more pituitary surgeries but had not been treated medically or 2) de novo patients presenting a visible pituitary adenoma on MRI who had refused pituitary surgery or for whom pituitary surgery was contraindicated.
Slovenian: Bolnike so randomizirali v razmerju 1:1 v eno od dveh študijskih skupin, obe sta bili stratificirani na naslednji dve kategoriji: 1. bolniki, ki so prestali eno ali več operacij hipofize, niso pa prejemali zdravil, in 2. novo odkriti bolniki, ki imajo na magnetnoresonančnem (MR) posnetku viden adenom hipofize in so odklonili operacijo hipofize ali je taka operacija za njih kontraindicirana.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in pituitary-dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Signifor za vse podskupine pediatrične populacije pri od hipofize odvisni Cushingovi bolezni, pri prekomerni tvorbi ACTH v hipofizi in pri od hipofize odvisnem hiperadrenokorticizmu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Pasireotide binds with high affinity to four of the five hssts.
Slovenian: Pasireotid se z veliko afiniteto veže na štiri od petih receptorjev hsst.
English: Your treatment with Signifor should continue for as long as your doctor tells you that it is necessary.
Slovenian: Z zdravljenjem z zdravilom Signifor boste nadaljevali tako dolgo, kot bo po zdravnikovi presoji potrebno.
English: The elevations of fasting plasma glucose and HbA1c observed with pasireotide intramuscular use treatment are reversible after discontinuation.
Slovenian: Zvišanje vrednosti glukoze v krvi na tešče in vrednosti HbA1c, ki so ga opažali pri zdravljenju s pasireotidom za intramuskularno uporabo, je po prekinitvi zdravljenja izzvenelo.
English: Pasireotide is a cyclohexapeptide, injectable somatostatin analogue.
Slovenian: Pasireotid je cikloheksapeptid, analog somatostatina v obliki za injiciranje.
English: In Cushing's disease patients, elevated FPG levels was the most frequently reported CTC Grade 3 laboratory abnormality (14.7% of patients) in the phase III study G2304; with no cases of Grade 4 reported.
Slovenian: Pri bolnikih s Cushingovo boleznijo je bila zvišana vrednost glukoze v plazmi na tešče (fasting plasma glucose, FPG) najpogosteje prijavljeni patološki laboratorijski izvid stopnje 3 po kriterijih CTC (pri 14,7 % bolnikov) v študiji faze III z oznako G2304, pri čemer niso poročali o nobenem primeru patološkega izvida stopnje 4.
English: INSTRUCTIONS FOR USE OF SIGNIFOR SOLUTION FOR INJECTION
Slovenian: NAVODILA ZA UPORABO SIGNIFOR RAZTOPINE ZA INJICIRANJE
English: - Signifor may cause your blood sugar to increase.
Slovenian: - Zdravilo Signifor vam lahko zviša koncentracijo sladkorja v krvi.
English: 30 ampoules (5x6)
Slovenian: 30 ampul (5x6)
English: The degree of hyperglycaemia appeared to be higher in patients with pre-diabetic conditions or established diabetes mellitus.
Slovenian: Kaže, da je stopnja hiperglikemije višja pri bolnikih s predstopnjo sladkorne bolezni in pri tistih z že ugotovljeno sladkorno boleznijo.
English: Acromegaly study C2305 patients who had no prior medical treatment A phase III multicentre, randomised, blinded study was conducted to assess the safety and efficacy of pasireotide intramuscular use versus octreotide intramuscular use in medically naïve patients with active acromegaly.
Slovenian: Študija akromegalije z oznako C2305, bolniki, ki predhodno še niso bili zdravljeni Multicentrično, randomizirano, slepo študijo faze III so izvajali za presojo varnosti in učinkovitosti intramuskularne uporabe pasireotida v primerjavi z intramuskularno uporabo oktreotida pri bolnikih z aktivno akromegalijo, ki predhodno še niso bili zdravljeni.
English: Remove the lid film of the vial adapter packaging, but do NOT remove the vial adapter from its packaging.
Slovenian: Potegnite zaščito z ovojnine adapterja za vialo, vendar adapterja NE vzemite iz ovojnine.
English: Alterations in blood glucose levels have been frequently reported in healthy volunteers and patients treated with pasireotide.
Slovenian: Pri zdravih prostovoljcih in bolnikih, ki so prejemali pasireotid, so pogosto poročali o spremembah ravni glukoze v krvi.
English: Health-related quality of life measured by AcroQol indicated statistically significant improvements in the Physical, Psychological-Appearance and Global scores in both treatment groups at month 12.
Slovenian: Z zdravjem povezana kakovost življenja, ki so jo ocenjevali s pomočjo vprašalnika AcroQol, se je v obeh študijskih skupinah statistično značilno izboljšala do konca 12. meseca pri oceni telesnega počutja, oceni psihičnega počutja in videza ter pri skupni oceni.
English: Patients with significantly increased prothrombin time (PT) and partial thromboplastin time (PTT) values or patients receiving coumarin-derivative or heparin-derivative anticoagulants were excluded from clinical studies with pasireotide as the safety of the combination with such anticoagulants has not been established.
Slovenian: V klinične študije s pasireotidom niso bili vključeni bolniki s pomembno zvišanimi vrednostmi protrombinskega časa (PČ) in parcialnega tromboplastinskega časa (PTČ) ter bolniki, ki so prejemali zdravila proti strjevanju krvi (derivate kumarina ali heparina), saj varnost sočasne uporabe s takimi antikoagulanti ni bila potrjena.
English: Ultrasonic examination of the gallbladder before and at 6 to 12 month intervals during Signifor therapy is therefore recommended.
Slovenian: Iz tega razloga je priporočeno opraviti ultrazvočni pregled žolčnika pred začetkom zdravljenja z zdravilom Signifor, v času zdravljenja pa v 6- do 12-mesečnih intervalih.
English: GH <2.5 μg/l
Slovenian: rastni hormon <2,5 μg/l
English: - Do not use this medicine after the expiry date which is stated on the carton, vial and pre-filled syringe after “EXP”.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, viali in napolnjeni injekcijski brizgi poleg oznak “EXP”/“Uporabno do”.
English: In medically naïve patients (study C2305), the mean absolute increase in FPG and HbA1c was similar at most of the time points for all patients treated with pasireotide intramuscular use irrespective of baseline values.
Slovenian: Pri bolnikih, ki pred tem še niso bili zdravljeni (študija C2305), je bilo povprečno absolutno zvišanje vrednosti glukoze v krvi na tešče in vrednosti HbA1c približno enako pri večini načrtovanih meritev pri vseh bolnikih, ki so prejemali pasireotid za intramuskularno uporabo, ne glede na izhodiščne vrednosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in acromegaly and pituitary gigantism, and in pituitary dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Signifor za vse podskupine pediatrične populacije pri akromegaliji in hipofiznem gigantizmu ter pri od hipofize odvisni Cushingovi bolezni, pri prekomerni tvorbi ACTH v hipofizi in pri od hipofize odvisnem hiperadrenokorticizmu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The primary efficacy endpoint was the proportion of patients with a reduction of mean GH level to <2.5 μg/l and the normalisation of IGF-1 to within normal limits (age and sex related) at month 12.
Slovenian: Primarni cilj opazovanja glede učinkovitosti je bil delež bolnikov z znižanjem povprečne koncentracije rastnega hormona na <2,5 μg/l in normalizacijo vrednosti faktorja IGF-1 v okvir normalnih vrednosti (glede na starost in spol) po 12 mesecih.
English: Pasireotide is eliminated mainly via hepatic clearance (biliary excretion), with a small contribution of the renal route.
Slovenian: Pasireotid se izloča predvsem preko jeter (z biliarno ekskrecijo) in v majhnem obsegu tudi preko ledvic.
English: In clinical studies in Cushing's disease patients, QTcF of >500 msec was observed in two out of 201 patients.
Slovenian: V kliničnih študijah pri bolnikih s Cushingovo boleznijo so pri dveh bolnikih od 201 opažali dolžino intervala QTcF več kot 500 milisekund.
English: Inadequately controlled patients in study C2402 are defined as patients with a mean GH concentration of a 5-point profile over a 2-hour period >2.5 μg/l and sex- and age-adjusted IGF-1 >1.3 × ULN.
Slovenian: Bolniki z neustrezno urejeno boleznijo so bili v študiji C2402 opredeljeni kot bolniki s povprečno koncentracijo rastnega hormona v 5-točkovnem profilu, izmerjenem v 2 urah, >2,5 μg/l in z na spol in starost prilagojeno koncentracijo faktorja IGF-1, ki presega 1,3-kratnik zgornje meje normalnih vrednosti (>1,3 × ZMN).
English: The safety profile of Signifor was consistent with the somatostatin analogue class, except for the occurrence of hypocortisolism and degree of hyperglycaemia.
Slovenian: Varnostni profil zdravila Signifor so bil podoben kot pri drugih zdravilih iz skupine analogov somatostatina z izjemo pojavljanja hipokortizolizma in stopnje hiperglikemije.
English: Do not use Signifor if the solution is not clear or contains particles.
Slovenian: Zdravila Signifor ne uporabljajte, če raztopina ni bistra ali če vsebuje delce.
English: At month 6, normalisation of mean UFC levels was observed in 14.6% (95% CI 7.0-22.3) and 26.3% (95% CI 16.6-35.9) of patients randomised to pasireotide 0.6 mg and 0.9 mg twice daily, respectively.
Slovenian: Po 6 mesecih so opažali normalizacijo povprečne vrednosti UFC pri 14,6 % (95-odstotni IZ 7,0-22,3) bolnikov, ki so bili randomizirani na 0,6 mg pasireotida dvakrat na dan, in pri 26,3 % (95-odstotni IZ 16,6-35,9) bolnikov, ki so bili randomizirani na 0,9 mg pasireotida dvakrat na dan.
English: At month 7, a mUFC response was achieved in 41.9% and 40.8% of patients randomised to starting doses of 10 mg and 30 mg, respectively.
Slovenian: Po 7 mesecih je odziv z vrednostjo mUFC doseglo 41,9 % bolnikov, ki so bili randomizirani na začetni odmerek 10 mg, in 40,8 % bolnikov, ki so bili randomizirani na začetni odmerek 30 mg.
English: The recommended initial dose for patients with moderate hepatic impairment (Child Pugh B) is 0.3 mg twice a day (see section 5.2).
Slovenian: Pri bolnikih z zmerno okvaro jeter (Child Pugh stopnje B) je priporočeni začetni odmerek 0,3 mg dvakrat na dan (glejte poglavje 5.2).
English: Renal impairment No dose adjustment is required in patients with impaired renal function (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvarjenim delovanjem ledvic prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
English: Solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Slovenian: v vehiklu: natrijev karmelozat, manitol, poloksamer 188, voda za injekcije.