FrancophonIA/ELRC3.0 huggingface dataset:
English: If uncontrolled hyperglycaemia persists despite appropriate medical management, the dose of Signifor should be reduced or Signifor treatment discontinued (see also section 4.5).
Slovenian: Če hiperglikemije ni mogoče odpraviti z ustreznimi zdravili, je treba odmerek zdravila Signifor znižati ali prekiniti zdravljenje z njim (glejte tudi poglavje 4.5).
English: The study met the primary efficacy objective for both dose groups (lower bound of the 95% CI for the response rate of each treatment arm >15%).
Slovenian: V študiji so dosegli primarni cilj učinkovitosti v obeh odmernih skupinah (spodnja meja 95-odstotnega intervala zaupanja za stopnjo odziva pri vsaki od odmernih skupin višja od 15 %).
English: At therapeutic dose levels pasireotide is also not an inhibitor of UGT1A1, OATP, 1B1 or 1B3, P-gp, BCRP, MRP2 and BSEP.
Slovenian: Pasireotid na ravni terapevtskih odmerkov prav tako ni zaviralec UGT1A1, OATP, 1B1 ali 1B3, P-gp, BCRP, MRP2 in BSEP.
English: Patients with baseline HbA1c ≥7% or who were taking antidiabetic medicinal products prior to randomisation tended to have higher mean changes in fasting plasma glucose and HbA1c relative to other patients.
Slovenian: Pri bolnikih, ki so imeli izhodiščno vrednost HbA1c ≥7 % ali so pred randomizacijo že jemali antidiabetična zdravila, je prišlo do nekoliko večje povprečne spremembe vrednosti glukoze v plazmi na tešče in HbA1c v primerjavi z drugimi bolniki.
English: Patients were randomised in a 1:1 ratio to receive starting doses of either 10 mg or 30 mg pasireotide, with a possibility to up-titrate to a maximum dose of 40 mg every 28 days.
Slovenian: Bolniki so bili randomizirani v razmerju 1:1 na prejemanje začetnih odmerkov bodisi 10 mg ali 30 mg pasireotida z možnostjo zviševanja do najvišjega odmerka 40 mg vsakih 28 dni.
English: • metformin, liraglutide, vildagliptin, nateglinide (antidiabetic medicines); - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Slovenian: • metformin, liraglutid, vildagliptin, nateglinid (antidiabetiki); - zdravila za zdravljenje nepravilnega srčnega ritma, kot so zdravila, ki vsebujejo dizopiramid,
English: If the finding is confirmed, the patient should be followed with frequent liver function monitoring until values return to pre-treatment levels.
Slovenian: V primeru potrjenega izvida je treba pri bolniku pogosto določati jetrno funkcijo, dokler se vrednosti ne vrnejo na raven pred zdravljenjem.
English: In patients with poor glycaemic control, diabetes management and monitoring should be intensified prior to initiation and during pasireotide therapy.
Slovenian: Pri bolnikih s slabo urejeno glikemijo je treba pred začetkom zdravljenja s pasireotidom in med samim zdravljenjem z njim intenzivirati zdravljenje in nadzor sladkorne bolezni.
English: In healthy volunteers, pasireotide intramuscular use is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
Slovenian: Pri zdravih prostovoljcih se pasireotid za intramuskularno uporabo obsežno porazdeli z velikim navideznim volumnom porazdelitve (Vz/F >100 litrov).
English: At month 12, reduction in tumour volume was comparable between the treatment groups and in patients with and without previous pituitary surgery.
Slovenian: Po 12 mesecih je bilo zmanjšanje tumorja primerljivo v obeh študijskih skupinah ter med bolniki s predhodno operacijo hipofize oziroma brez nje.
English: If not used within 24 hours, the injection kit can be returned to the fridge.
Slovenian: Če kompleta niste uporabili v roku 24 ur, ga lahko ponovno shranite v hladilnik.
English: What Signifor looks like and contents of the pack Signifor powder is a slightly yellowish to yellowish powder in a vial.
Slovenian: Izgled zdravila Signifor in vsebina pakiranja Prašek zdravila Signifor je nekoliko rumenkast do rumenkast prašek v viali.
English: 6 ampoules
Slovenian: 6 ampul
English: Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4).
Slovenian: Pri bolnikih, ki prejemajo zdravilo Signifor, je priporočeno spremljanje vrednosti glukoze v krvi (glejte poglavje 4.4).
English: Your doctor or nurse will instruct you on how to inject yourself with Signifor.
Slovenian: Zdravnik ali medicinska sestra vas bosta naučila, kako si lahko sami injicirate zdravilo Signifor.
English: The primary efficacy endpoint was met; the percentage of patients achieving biochemical control was 31.3% and 19.2% for pasireotide intramuscular use and octreotide intramuscular use, respectively, demonstrating a statistically significant superior result favouring pasireotide intramuscular use (p-value = 0.007) (Table 4).
Slovenian: Primarni cilj opazovanja je bil dosežen; delež bolnikov, ki so dosegli biokemijsko urejenost, je bil 31,3 % pri intramuskularni uporabi pasireotida in 19,2 % pri intramuskularni uporabi oktreotida, in sicer s statistično značilno boljšim rezultatom pri intramuskularni uporabi pasireotida (vrednost p = 0,007) (preglednica 4).
English: The proportion of patients who either attained mUFC ≤ULN or a mUFC reduction from baseline of at least 50% was 50.0% in the 10 mg dose group and 56.6% in the 30 mg dose groups (Table 5).
Slovenian: Delež bolnikov, pri katerih je prišlo bodisi do znižanja vrednosti mUFC ≤ ZMN ali do znižanja vrednosti mUFC za najmanj 50 % od izhodiščne vrednosti, je bil v odmerni skupini z odmerkom 10 mg 50,0 %, v odmerni skupini z odmerkom 30 mg pa 56,6 % (preglednica 5).
English: Biochemical control was achieved early in the study (i.e. month 3) by a higher proportion of patients in the pasireotide intramuscular use arm than in the octreotide intramuscular use arm (30.1% and 21.4%) and was maintained in all subsequent evaluations during the core phase.
Slovenian: Biokemijsko urejenost v zgodnjem poteku študije (po 3 mesecih) so bolniki v večjem deležu dosegli v skupini z intramuskularno uporabo pasireotida kot v skupini z intramuskularno uporabo oktreotida (30,1 % v primerjavi z 21,4 %), ohranili pa so jo pri vseh nadaljnjih meritvah v osnovni fazi študije.
English: The efficacy and safety of pasireotide intramuscular use was evaluated in a phase III, multicentre study over a 12-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Slovenian: Učinkovitost in varnost pasireotida za intramuskularno uporabo so ocenjevali v multicentrični študiji faze III v 12-mesečnem obdobju zdravljenja pri bolnikih s Cushingovo boleznijo, ki so imeli persistentno ali ponavljajočo bolezen oziroma so jim bolezen šele odkrili in niso bili primerni za kirurški poseg ali pa so ga odklonili.
English: The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus.
Slovenian: Najpogostejši neželeni učinki (s pogostnostjo ≥ 1/10) v študiji faze III z oznako G2304 so bili hiperglikemija, diareja, holelitiaza in sladkorna bolezen.
English: Patients who develop increased transaminase levels should be monitored frequently until values return to pre-treatment levels.
Slovenian: Pri bolnikih, pri katerih je prišlo do zvišanja vrednosti aminotransferaz, je treba te pogosto določati, dokler se vrednosti ne vrnejo na raven pred zdravljenjem.
English: Management of suspected adverse reactions at any time during the treatment may require temporary dose reduction of Signifor.
Slovenian: Pri sumu na neželen učinek kadarkoli v času zdravljenja je v nekaterih primerih treba začasno znižati odmerek zdravila Signifor.
English: The response in the 0.9 mg dose arm seemed to be higher for patients with lower mean UFC at baseline.
Slovenian: Kaže, da je bil v skupini z odmerkom 0,9 mg odziv večji pri bolnikih, ki so imeli nižjo povprečno vrednost UFC ob izhodišču.
English: The proportion of patients with a reduction of tumour volume greater than 20% at month 12 was 80.8% for pasireotide intramuscular use and 77.4% for octreotide intramuscular use.
Slovenian: Delež bolnikov z zmanjšanjem tumorske mase za več kot 20 % je bil po 12 mesecih 80,8 % v skupini z intramuskularno uporabo pasireotida in 77,4 % v skupini z intramuskularno uporabo oktreotida.
English: Pull slightly on the plunger to check that a blood vessel has not been punctured.
Slovenian: Bat potegnite nekoliko nazaj, da se prepričate, da niste nabodli krvne žile.
English: Reductions in plasma ACTH levels were also observed at each time point for each dose group.
Slovenian: Ob vsakem času opazovanja so pri obeh skupinah z različnima odmerkoma opažali tudi znižanje vrednosti ACTH v plazmi.
English: The phase III clinical studies in acromegaly patients did not identify any clinically meaningful differences in the QT prolongation events between pasireotide intramuscular use and the somatostatin analogues which were tested as active comparator.
Slovenian: V kliničnih študijah faze III pri bolnikih z akromegalijo niso ugotovili nobenih klinično pomembnih razlik v s podaljševanjem intervala QT povezanih dogodkih, med intramuskularno uporabo pasireotida in uporabo analogov somatostatina, ki so bili uporabljeni kot primerjalno zdravilo.
English: Patients had to be treated with maximum indicated doses of octreotide intramuscular use (30 mg) or lanreotide deep subcutaneous injection (120 mg) for at least 6 months prior to randomisation.
Slovenian: Bolniki so morali biti pred randomizacijo najmanj 6 mesecev zdravljeni z najvišjimi indiciranimi odmerki oktreotida za intramuskularno uporabo (30 mg) ali lanreotida za globoko subkutano injiciranje (120 mg).
English: Following discontinuation of treatment with pasireotide, patients should be monitored until resolution.
Slovenian: Po prekinitvi zdravljenja s pasireotidom je treba bolnike spremljati do normalizacije izvidov.
English: At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor.
Slovenian: Pri vstopu v študijo so bolnike randomizirali tako, da so dvakrat na dan prejemali bodisi 0,6 mg ali 0,9 mg zdravila Signifor.
English: In study C2402, the only notable outlier was a QTcF value >480 ms in 1 patient in the pasireotide intramuscular use 40 mg group.
Slovenian: V študiji C2402 je bila edina opazna izredna vrednost trajanje intervala QTcF več kot 480 ms pri enem bolniku iz skupine s pasireotidom za intramuskularno uporabo v odmerku 40 mg.
English: The unbound plasma pasireotide exposure (AUCinf,u) was increased in subjects with renal impairment (mild: 33%; moderate: 25%, severe: 99%, ESRD: 143%) compared to control subjects.
Slovenian: Povečana pa je bila izpostavljenost nevezanemu pasireotidu pri osebah z okvaro ledvic (blaga okvara: 33 %, zmerna okvara: 25 %, huda okvara: 99 %, končna odpoved ledvic: 143 %) glede na kontrolo.
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including ACTH in Cushing's disease.
Slovenian: Receptorji za somatostatin se izražajo v mnogih tkivih, zlasti v nevroendokrinih tumorjih, v katerih se prekomerno sproščajo hormoni, vključno z ACTH pri Cushingovi bolezni.
English: Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor.
Slovenian: Pri sumu na neželen učinek ali premočnem odzivu na zdravljenje (IGF-1 < spodnje meje normalne vrednosti) je v nekaterih primerih treba začasno znižati odmerek zdravila Signifor.
English: After you have started treatment, your doctor may reassess your dose.
Slovenian: Po začetku zdravljenja lahko zdravnik ponovno oceni, kolikšen odmerek potrebujete.
English: Remove the plastic cap from the vial and clean the rubber stopper of the vial with an alcohol wipe.
Slovenian: Z viale snemite plastični pokrovček in očistite gumijasto zaporko na viali z alkoholnim zložencem.
English: In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
Slovenian: V kliničnih študijah pri osebah z okvaro jetrne funkcije (Child-Pugh razredov A, B in C) so ugotovili statistično značilne razlike pri osebah z zmerno oziroma s hudo okvaro jeter (Child-Pugh razredov B in C).
English: Acromegaly is caused by a type of tumour called a pituitary adenoma which develops in the pituitary gland at the base of the brain.
Slovenian: Akromegalijo povzroča vrsta tumorja z imenom adenom hipofize, ki nastane v hipofizi na spodnji strani možganov.
English: Glucose metabolism
Slovenian: Metabolizem glukoze
English: Switch from subcutaneous to intramuscular formulation in Cushing's disease There are no clinical data available on switching from the subcutaneous to the intramuscular pasireotide formulation.
Slovenian: Prehod s subkutane na intramuskularno obliko zdravila pri Cushingovi bolezni Kliničnih podatkov glede prehoda s subkutane na intramuskularno obliko pasireotida ni na voljo.
English: After you have started treatment, your doctor may also decide to increase your dose to one ampoule of Signifor 0.9 mg twice a day.
Slovenian: Po začetku zdravljenja se lahko zdravnik odloči, da vam zviša odmerek na eno ampulo zdravila Signifor 0,9 mg dvakrat na dan.
English: Most patients (83.3%) had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
Slovenian: Večina bolnikov (83,3 %) je imela persistentno ali rekurentno obliko Cushingove bolezni in nekaj bolnikov (≤5 %) iz vsake od zdravljenih skupin je bilo predhodno zdravljenih z obsevanjem hipofize.
English: Put the needle into the ampoule and pull the plunger to draw up the entire contents of the ampoule into the syringe.
Slovenian: Iglo vstavite v ampulo in potegnite bat, tako da povlečete vso vsebino iz ampule v brizgo.
English: Injection site reaction*
Slovenian: reakcija na mestu injiciranja*
English: Avoid soreness and skin irritation by choosing a different site from the previous one for each injection.
Slovenian: Bolečini in vnetju kože se poskušajte izogniti tako, da si vsakokrat izberete drugo mesto injiciranja.
English: Signifor solution for injection should be free of visible particles, clear and colourless.
Slovenian: Raztopina za injiciranje Signifor ne sme vsebovati vidnih delcev in mora biti bistra in brezbarvna.
English: In addition, monitoring of FPG 4 weeks and HbA1c 3 months after the end of the treatment should be performed.
Slovenian: Poleg tega je treba vrednosti glukoze na tešče spremljati še 4 tedne po zaključku zdravljenja, vrednosti HbA1c pa 3 mesece po zaključku zdravljenja.
English: Rapid decreases in cortisol levels may be associated with decreases in white blood cell count.
Slovenian: Hitro znižanje ravni kortizola je lahko povezano z znižanjem števila levkocitov.
English: Signifor is intended for intramuscular use.
Slovenian: Zdravilo Signifor je namenjeno za intramuskularno uporabo.
English: 60 ampoules (10x6)
Slovenian: 60 ampul (10x6)
English: Two cases of hyperglycaemia-related emergencies (diabetic ketoacidosis and diabetic hyperglycaemic coma) were reported following a dose increase of pasireotide to 60 mg in medical treatment naïve patients; one in a patient with untreated hyperglycaemia and HbA1c >8% prior to initiation of pasireotide and the other in a patient with untreated hyperglycaemia and a fasting plasma glucose of 359 mg/dl, respectively.
Slovenian: Pri dveh bolnikih, ki pred tem še nista bila zdravljena, so poročali o pojavu nujnih stanj zaradi hiperglikemije (diabetični ketoacidozi in diabetični hiperglikemični komi) po zvišanju odmerka pasireotida na 60 mg; v enem primeru je šlo za bolnika z nezdravljeno hiperglikemijo in HbA1c >8 % pred začetkom zdravljenja s pasireotidom in v drugem primeru za bolnika z nezdravljeno hiperglikemijo in s koncentracijo glukoze na tešče 359 mg/dl.
English: Month 12 * Includes one patient with significant outlying results who had a percent change from baseline of
Slovenian: 12 mesecih * vključuje bolnika z izrazito izstopajočimi vrednostmi, pri katerem je bila odstotna sprememba od izhodišča +542,2 %
English: Dose adjustment of medicinal products such as beta blockers, calcium channel blockers, or medicinal products to control electrolyte balance, may be necessary (see also section 4.5).
Slovenian: V nekaterih primerih je treba prilagoditi tudi odmerjanje zdravil, kot so antagonisti adrenergičnih receptorjev beta, zaviralci kalcijevih kanalčkov ali zdravil za uravnavanje elektrolitskega ravnovesja (glejte tudi poglavje 4.5).
English: Population PK analyses of pasireotide intramuscular use suggest that race does not influence PK parameters.
Slovenian: Analiza populacijske farmakokinetike pasireotida za intramuskularno uporabo kaže, da rasa ne vpliva na farmakokinetične parametre.
English: Acromegaly
Slovenian: Akromegalija
English: For further details on handling, see section 6.6.
Slovenian: Za podrobnejša navodila za rokovanje z zdravilom glejte poglavje 6.6.
English: Signifor is to be administered by deep intramuscular injection by a trained healthcare professional.
Slovenian: Zdravilo Signifor mora z globoko intramuskularno injekcijo dati usposobljen zdravstveni delavec.
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding.
Slovenian: Pri bolnikih, pri katerih je prišlo do zvišanja vrednosti aminotransferaz, je treba za potrditev izvida opraviti še eno oceno jetrne funkcije.
English: Table 1 Adverse reactions in the phase III study in Cushing's disease patients
Slovenian: Preglednica 1 Neželeni učinki v študiji faze III pri bolnikih s Cushingovo boleznijo
English: In study C2402, grade 3 elevated fasting glucose levels were reported in 14.3% and 17.7% of acromegaly patients treated with pasireotide intramuscular use 40 mg and 60 mg respectively, and in no patients in the active control group.
Slovenian: V študiji C2402 so o stopnji 3 zvišanja vrednosti glukoze v krvi na tešče poročali pri 14,3 % oziroma 17,7 % bolnikov z akromegalijo, ki so prejemali pasireotid za intramuskularno uporabo v odmerku 40 mg oziroma v odmerku 60 mg, in pri nobenem od bolnikov iz aktivne kontrolne skupine.
English: Pasireotide demonstrates low clearance (CL/F ~7.6 litres/h for healthy volunteers and ~3.8 litres/h for Cushing's disease patients).
Slovenian: Pasireotid ima majhen očistek (CL/F je pri zdravih prostovoljcih ~7,6 l/h, pri bolnikih s Cushingovo boleznijo pa ~3,8 l/h).
English: The safety profile of pasireotide intramuscular use is consistent with the somatostatin analogue class, except for the higher degree and frequency of hyperglycaemia seen with pasireotide intramuscular use.
Slovenian: Varnostni profil pasireotida za intramuskularno uporabo je bil podoben kot pri drugih zdravilih iz skupine analogov somatostatina, z izjemo povečane stopnje in pogostnosti hiperglikemije, ki so jo opažali pri intramuskularni uporabi pasireotida.
English: Remove the packaging from the vial adapter by lifting it straight up as shown.
Slovenian: Odstranite ovojnino z adapterja za vialo s potegom naravnost navzgor, kot je prikazano na sliki.
English: Injection site reaction includes injection site pain, injection site nodule, injection site discomfort, injection site bruising, injection site pruritus, injection site reaction, injection site hypersensitivity and injection site swelling.
Slovenian: Reakcija na mestu injiciranja vključuje bolečino na mestu injiciranja, vozliček na mestu injiciranja, neprijeten občutek na mestu injiciranja, podplutbo na mestu injiciranja, srbenje na mestu injiciranja, reakcijo na mestu injiciranja, preobčutljivost na mestu injiciranja in oteklino na mestu injiciranja.
English: Rare cases of concurrent elevations in ALT (alanine aminotransferase) greater than 3 x ULN and bilirubin greater than 2 x ULN have also been observed (see section 4.8).
Slovenian: Redko so opažali tudi primere sočasno zvišanih vrednosti ALT (alaninaminotransferaze) nad 3-kratnik zgornje meje normalnih vrednosti (ZMN) in bilirubina nad 2-kratnik ZMN (glejte poglavje 4.8).
English: Signifor is available in packs containing 6 ampoules or in multipacks containing 18 (3 packs of 6), 30 (5 packs of 6) or 60 (10 packs of 6) ampoules.
Slovenian: Zdravilo Signifor je na voljo v pakiranju, ki vsebuje 6 ampul, ali v skupnem pakiranju, ki vsebuje 18 (3 pakiranja po 6), 30 (5 pakiranj po 6) ali 60 (10 pakiranj po 6) ampul.
English: Packs containing 6 ampoules or multipacks containing 18 (3 x 6), 30 (5 x 6) or 60 (10 x 6) ampoules.
Slovenian: Pakiranje vsebuje 6 ampul, skupno pakiranje pa vsebuje 18 (3 x 6), 30 (5 x 6) ali 60 (10 x 6) ampul.
English: In both studies, mean FPG and HbA1c levels peaked within the first three months of treatment with pasireotide intramuscular use.
Slovenian: V obeh študijah sta povprečna vrednost glukoze v krvi na tešče in povprečna vrednost HbA1c dosegli najvišje vrednosti v prvih treh mesecih zdravljenja s pasireotidom za intramuskularno uporabo.
English: Somatostatin receptors are expressed in many tissues, especially in neuroendocrine tumours in which hormones are excessively secreted, including GH in acromegaly and ACTH in Cushing's disease.
Slovenian: Receptorji za somatostatin se izražajo v mnogih tkivih, zlasti v nevroendokrinih tumorjih, v katerih se prekomerno sproščajo hormoni, vključno z rastnim hormonom pri akromegaliji in ACTH pri Cushingovi bolezni.
English: A baseline ECG is recommended prior to initiating therapy with Signifor.
Slovenian: Izhodiščno EKG preiskavo je priporočeno izvesti pred začetkom zdravljenja z zdravilom Signifor.
English: Pharmacokinetic steady state for pasireotide intramuscular use is achieved after three months.
Slovenian: Pasireotid za intramuskularno uporabo doseže stanje farmakokinetičnega dinamičnega ravnovesja po treh mesecih.
English: In the Cushing's disease study G2304, a QTcF value >480 ms was reported for 2 patients.
Slovenian: V študiji Cushingove bolezni z oznako G2304 so o intervalu QTcF, daljšem od 480 ms, poročali pri 2 bolnikih.
English: If you have liver disease before you start Signifor treatment, your doctor may want to start your treatment with a dose of one ampoule of Signifor 0.3 mg twice a day.
Slovenian: Če imate pred začetkom zdravljenja z zdravilom Signifor jetrno bolezen, vam bo zdravnik za začetek morda predpisal odmerek ene ampule zdravila Signifor 0,3 mg dvakrat na dan.
English: Solvent: clear, colourless to slightly yellow or slightly brown solution.
Slovenian: Vehikel: bistra, brezbarvna do nekoliko rumena ali nekoliko rjava raztopina.
English: Pasireotide is not recommended for use during pregnancy and in women of childbearing potential who are not using contraception (see section 4.4).
Slovenian: Pasireotida ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.4).
English: Monitoring of liver enzymes is recommended before and during treatment with Signifor (see section 4.4), as clinically appropriate.
Slovenian: Pred in med zdravljenjem z zdravilom Signifor je priporočeno spremljanje vrednosti jetrnih encimov (glejte poglavje 4.4), in sicer v skladu s kliničnimi potrebami.
English: The primary efficacy end-point was the proportion of patients in each arm who achieved normalisation of mean 24-hour UFC levels (UFC ≤ULN) after 6 months of treatment and who did not have a dose increase (relative to randomised dose) during this period.
Slovenian: Primarni cilj opazovanja za oceno učinkovitosti je bil v vsaki skupini delež bolnikov, ki so po 6 mesecih zdravljenja dosegli normalizacijo 24-urne vrednosti UFC (UFC ≤ZMN) in jim v tem obdobju niso zvišali odmerka (v primerjavi z odmerkom, določenim pri randomizaciji).
English: The most common adverse reactions (incidence ≥10%) were diarrhoea, nausea, abdominal pain, cholelithiasis, injection site reactions, hyperglycaemia, diabetes mellitus, fatigue and glycosylated haemoglobin increased.
Slovenian: Najbolj pogosti neželeni učinki (s pogostnostjo ≥10 %) so bili diareja, navzea, bolečine v trebuhu, holelitiaza, reakcije na mestu injiciranja, hiperglikemija, sladkorna bolezen, utrujenost in zvišana vrednost glikiranega hemoglobina.