natgillin/translations-raw huggingface dataset:
Based on in vitro data pasireotide appears to be a substrate of efflux transporter P-gp (P-glycoprotein).
Na temelju in vitro podataka, čini se da je pasireotid supstrat P-gp (P-glikoprotein) transportera za izbacivanje.
After three months of treatment, patients with a mean 24-hour UFC ≤2 x ULN and below or equal to their baseline value continued blinded treatment at the randomised dose until month 6.
Nakon tri mjeseca liječenja, bolesnici sa srednjim 24-satnim UFC-om ≤2 x GGN i niže ili jednako početnoj vrijednosti nastavili su sa slijepim liječenjem uz randomiziranu dozu do 6. mjeseca.
Dose increase for efficacy was allowed at the discretion of the investigators after three and six months of treatment if biochemical parameters showed a mean GH ≥2.5 µg/l and/or IGF-1 >ULN (age and sex related).
Povećanje doze za djelotvornost bilo je dopušteno prema odluci ispitivača nakon tri i šest mjeseci liječenja ako su biokemijski parametri pokazali srednji GH ≥2,5 µg/l i/ili IGF-1 >GGN (povezano s dobi i spolom).
Activate the safety guard over the needle, in one of the two methods shown: - either press the hinged section of the safety guard down onto a hard surface - or push the hinge forward with your finger An audible “click” confirms proper activation.
Aktivirajte štitnik preko igle, na jedan od dva prikazana načina: - ili pritisnite pregibni dio štitnika o tvrdu površinu - ili prstom gurnite pregibni dio prema naprijed Čut ćete “klik” kao potvrdu pravilne aktivacije.
Alterations in blood glucose levels have been frequently reported in healthy volunteers and patients treated with pasireotide.
Bilo je učestalih izvješća o promjenama u razinama glukoze u krvi kod zdravih dobrovoljaca i bolesnika liječenih pasireotidom.
FOR DEEP INTRAMUSCULAR INJECTION ONLY.
SAMO ZA DUBOKU INTRAMUSKULARNU INJEKCIJU.
Glycaemic status (fasting plasma glucose/haemoglobin A1c [FPG/HbA1c]) should be assessed prior to starting treatment with pasireotide.
Glikemijski status (omjer glukoze u plazmi natašte i hemoglobina A1c [FPG; engl. fasting plasma glucose/HbA1c]) treba procijeniti prije početka liječenja pasireotidom.
Activate the safety guard over the needle, in one of the two methods shown: - either press the hinged section of the safety guard down onto a hard surface (figure A), - or push the hinge forward with your finger
Aktivirajte štitnik preko igle, na jedan od dva prikazana načina: - ili pritisnite pregibni dio štitnika o tvrdu površinu (slika A), - ili prstom gurnite pregibni dio prema naprijed (slika B).
51.6% p=0.536 * Primary endpoint (patients with IGF-1 <lower limit of normal (LLN) were not considered “responders”).
51,6% p=0,536 * Mjera primarnog ishoda (bolesnici s IGF-1 ispod donje granice normale (DGN) nisu se smatrali bolesnicima s odgovorom).
Pasireotide works in a very similar way to somatostatin.
Pasireotid funkcionira vrlo slično somatostatinu.
- Signifor controls over-production of cortisol.
- Signifor kontrolira prekomjerno stvaranje kortizola.
Mean improvements from baseline were greater for pasireotide intramuscular use than for octreotide intramuscular use with no statistical significance.
Srednja poboljšanja od početne vrijednosti bila su veća za pasireotid primijenjen intramuskularno nego za oktreotid primijenjen intramuskularno bez statističke značajnosti.
Monitoring of liver enzymes is recommended before and during treatment with Signifor (see section 4.4), as clinically appropriate.
Preporučuje se praćenje jetrenih enzima prije i tijekom liječenja Signiforom (vidjeti dio 4.4), u skladu s kliničkim potrebama.
Hypokalaemia and/or hypomagnesaemia must be corrected prior to administration of Signifor and should be monitored periodically during therapy.
Hipokalijemiju i/ili hipomagnezemiju treba korigirati prije primjene Signifora te periodički pratiti tijekom terapije.
Due to the increase in unbound drug exposure, Signifor should be used with caution in patients with severe renal impairment or end stage renal disease (see section 5.2).
Zbog povećane izloženosti nevezanom lijeku, Signifor se treba oprezno primjenjivati u bolesnika s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega (vidjeti dio 5.2).
All observed cases of concurrent elevations were identified within ten days of initiation of treatment.
Svi uočeni slučajevi istodobnih povišenja bili su utvrđeni u roku od deset dana od početka liječenja.
Pasireotide is not recommended for use during pregnancy and in women of childbearing potential who are not using contraception (see section 4.4).
Ne preporučuje se koristiti pasireotid tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju (vidjeti dio 4.4).
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.
U objedinjenoj analizi tih dvaju ključnih ispitivanja, ukupna incidencija nuspojava povezanih s hiperglikemijom bila je 58,6% (svi stupnjevi) i 9,9% (stupanj 3 i 4 prema Zajedničkim kriterijima toksičnosti (CTC)) za Signifor primijenjen intramuskularno u odnosu na 18,0% (svi stupnjevi) i 1,1% (CTC stupanj 3 i 4) za aktivnu kontrolu.
Monitoring of liver function is recommended prior to treatment with pasireotide intramuscular use and after the first two to three weeks, then monthly for three months on treatment.
Praćenje jetrene funkcije preporučuje se prije liječenja pasireotidom primijenjenim intramuskularno te nakon prva dva do tri tjedna liječenja, a zatim svaki mjesec tijekom tri mjeseca za vrijeme liječenja.
More cases of discontinuation and a higher reporting rate of severe adverse events due to hyperglycaemia were reported in patients treated with the dose of 0.9 mg twice daily.
Prijavljeno je više slučajeva prekida primjene i više izvješća o teškim štetnim događajima uzrokovanim hiperglikemijom u bolesnika liječenih dozom od 0,9 mg dvaput na dan.
Ultrasonic examination of the gallbladder before and at 6 to 12 month intervals during Signifor therapy is therefore recommended.
Stoga se preporučuje pregled žučnog mjehura ultrazvukom prije te u intervalima od 6 do 12 mjeseci tijekom terapije Signiforom.
The study met the primary efficacy objective for the 0.9 mg twice-daily group as the lower limit of the 95% CI is greater than the pre-specified 15% boundary.
Ispitivanje je ispunilo primarni cilj djelotvornosti za skupinu koja je primala 0,9 mg dvaput na dan budući da je donja granica 95%-tnog CI veća od unaprijed određene granice od 15%.
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.
Dva slučaja hitnih stanja povezanih s hiperglikemijom (dijabetička ketoacidoza i dijabetička hiperglikemijska koma) prijavljena su nakon povećanja doze pasireotida na 60 mg u bolesnika bez prethodne terapije lijekovima; jedan u bolesnika s neliječenom hiperglikemijom i HbA1c >8% prije uvođenja pasireotida, a drugi u bolesnika s neliječenom hiperglikemijom i glukozom u plazmi natašte od 359 mg/dl.
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.
Kvaliteta života povezana sa zdravljem mjerena upitnikom AcroQol ukazala je na statistički značajna poboljšanja u rezultatima za fizičku komponentu, psihološku komponentu-izgled te u globalnom rezultatu u obje terapijske skupine u 12. mjesecu.
A baseline ECG is recommended prior to initiating therapy with Signifor.
Preporučuje se napraviti početni EKG prije početka terapije Signiforom.
Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Nuspojave 3. i 4. stupnja uglavnom su bile povezane s hiperglikemijom.
Health-related quality of life was assessed by a disease-specific patient-reported outcome measure (CushingQoL) and a generic quality of life measure (SF-12v2 General Health Survey).
Kvaliteta života povezana sa zdravljem bila je procijenjena pomoću upitnika za bolesnike za procjenu kvalitete života specifičnog za bolest (Cushing QoL) te općeg upitnika za procjenu kvalitete života (SF-12v2 General Health Survey).
Furthermore, a higher proportion of patients on pasireotide intramuscular use (18.5% and 10.8% for 40 mg and 60 mg, respectively) than active comparator (1.5%) achieved a reduction in tumour volume of at least 25%.
Nadalje, veći udio bolesnika na pasireotidu primijenjenom intramuskularno (18,5% za 40 mg i 10,8% za 60 mg) nego na aktivnom komparatoru (1,5%) postigao je smanjenje volumena tumora od najmanje 25%.
Non-clinical safety data from studies performed with pasireotide administered via the subcutaneous route reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Neklinički podaci o sigurnosti primjene iz ispitivanja provedenih s pasireotidom primijenjenim supkutano ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
If concomitant use of coumarin-derivative or heparin-derivative anticoagulants with Signifor intramuscular use cannot be avoided, patients should be monitored regularly for alterations in their coagulation parameters (PT and PTT) and the anticoagulant dose adjusted accordingly.
Ako se ne može izbjeći istodobna primjena antikoagulansa koji su derivati kumarina ili heparina sa Signiforom koji se primjenjuje intramuskularno, bolesnike treba redovito pratiti da bi se uočile eventualne promjene u parametrima koagulacije (PT i PTT) te sukladno tome prilagoditi dozu antikoagulansa.
Decreased appetite, type 2 diabetes mellitus, glucose tolerance impaired
Smanjeni apetit, šećerna bolest tipa 2, poremećena tolerancija glukoze
The suppression of ACTH (adrenocorticotropic hormone) secretion can result in hypocortisolism in patients treated with Signifor.
Supresija izlučivanja ACTH-a (adrenokortikotropnog hormona) može za posljedicu imati hipokortizolizam u bolesnika liječenih Signiforom.
One case of ketosis and one case of ketoacidosis have been reported during compassionate use of Signifor.
Tijekom milosrdne uporabe Signifora bio je prijavljen jedan slučaj ketoze i jedan slučaj ketoacidoze.
Dispose of the used syringe and needle immediately in a sharps container or other rigid closed disposal container.
Odmah odložite upotrijebljenu štrcaljku i iglu u spremnik za oštre predmete ili neki drugi čvrsti, zatvoreni spremnik za otpad.
If the finding is confirmed, the patient should be followed with frequent liver function monitoring until values return to pre-treatment levels.
Ako se nalaz potvrdi, kod bolesnika treba učestalo pratiti funkciju jetre dok se vrijednosti ne vrate na razine od prije liječenja.
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.
Nakon što ste započeli liječenje, liječnik bi mogao odlučiti da Vam poveća dozu na jednu ampulu Signifora od 0,9 mg dvaput na dan.
• After adding the solvent, shake the vial moderately for a minimum of 30 seconds until a uniform suspension is formed.
• Nakon što dodate otapalo, umjereno tresite bočicu najmanje 30 sekundi dok ne dobijete jednoličnu suspenziju.
You may experience extreme weakness, tiredness, weight loss, nausea,
Možete osjetiti izraženu slabost, umor, gubitak težine, mučninu,
In a clinical study with single subcutaneous dose administration of 900 µg pasireotide in subjects with impaired renal function, renal impairment of mild, moderate or severe degree, or end stage renal disease (ESRD) did not have a significant impact on total pasireotide plasma exposure.
U kliničkom ispitivanju s jednokratnom primjenom supkutane doze 900 µg pasireotida u ispitanika s oštećenom bubrežnom funkcijom, blago, umjereno ili teško oštećenje bubrega ili završni stadij bolesti bubrega (ESRD, engl. end stage renal disease) nisu imali značajan utjecaj na ukupnu izloženost pasireotidu u plazmi.
The study met its primary efficacy endpoint for both pasireotide intramuscular use doses.
Ispitivanje je ispunilo svoju mjeru primarnog ishoda djelotvornosti za obje doze pasireotida primijenjenog intramuskularno.
Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Ostavite set na sobnoj temperaturi najmanje 30 minuta prije rekonstitucije, ali ne duže od 24 sata.
Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of any major enzymes of CYP450.
Pasireotid je metabolički visoko stabilan, a in vitro podaci pokazuju da pasireotid nije supstrat, inhibitor ili induktor bilo kojeg od glavnih enzima CYP450.
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.
U bolesnika s Cushingovom bolešću, pasireotid pokazuje linearnu farmakokinetiku ovisnu o vremenu u rasponu doza od 0,3 mg do 1,2 mg dvaput na dan.
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.
Biokemijsku kontrolu postigao je rano u ispitivanju (tj. 3. mjesec) veći udio bolesnika u skupini s pasireotidom primijenjenim intramuskularno nego u skupini s oktreotidom primijenjenim intramuskularno (30,1% i 21,4%), a održala se u svim naknadnim ocjenjivanjima tijekom osnovne faze.
During your treatment with Signifor - Signifor controls over-production of cortisol.
Tijekom liječenja Signiforom - Signifor kontrolira prekomjerno stvaranje kortizola.
Avoid soreness and skin irritation by choosing a different site from the previous one for each injection.
Bol i nadražaj kože možete izbjeći tako što ćete za svaku injekciju odabrati drugo mjesto.
Most patients (82.0%) had undergone prior pituitary surgery, and the mean baseline mUFC was 470 nmol/24h (ULN: 166.5 nmol/24h).
Većina bolesnika (82,0%) prethodno je imala operaciju hipofize, a srednja početna vrijednost mUFC-a bila je 470 nmol/24h (GGN: 166,5 nmol/24h).
No studies have been conducted to evaluate the absolute bioavailability of pasireotide in humans.
Nisu provedena ispitivanja za procjenu apsolutne bioraspoloživosti pasireotida kod ljudi.
Amylase increased, prothrombin time prolonged
Povišenje amilaze, produljeno protrombinsko vrijeme
Especially, tell your doctor if you are using: - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Svakako recite liječniku ako uzimate: - lijekove koji liječe nepravilne otkucaje srca, kao što su lijekovi koji sadrže dizopiramid,
Pasireotide binds and activates four of the five hssts, especially hsst5, in corticotrophs of ACTH producing adenomas, resulting in inhibition of ACTH secretion.
Pasireotid veže i aktivira četiri od pet hsst-a, osobito hsst5, u kortikotropnim adenomima koji luče ACTH, što rezultira inhibicijom izlučivanja ACTH.
Pasireotide has been shown to prolong the QT interval on the ECG in two dedicated healthy volunteer studies performed with the subcutaneous formulation.
Dokazano je da pasireotid produžuje QT interval na EKG-u u dva posebna ispitivanja na zdravim dobrovoljcima koja su provedena sa supkutanom formulacijom.
One sterile syringe
Jedna sterilna štrcaljka
Abdominal pain includes abdominal pain and abdominal pain upper.
Bol u abdomenu uključuje bol u abdomenu i bol u gornjem dijelu abdomena.
Adverse reactions reported up to the cut-off date of the analysis are presented in Table 1.
Nuspojave prijavljene do isključnog datuma za analizu navedene su u Tablici
The response in the 0.9 mg dose arm seemed to be higher for patients with lower mean UFC at baseline.
Odgovor u kraku koji je primao dozu od 0,9 mg bio je viši za bolesnike s nižim srednjim UFC-om na početku.
The elevations were mostly asymptomatic, of low grade and reversible with continued treatment.
Povišenja su uglavnom bila asimptomatska, niskog stupnja i reverzibilna uz nastavak liječenja.
There is a limited amount of data from the use of pasireotide in pregnant women.
Podaci o primjeni pasireotida u trudnica su ograničeni.
Percentage of patients with: mUFC ≤ULN at Month 7 (95% CI) * mUFC ≤ULN and no prior dose increase at Month 7 (95% CI) mUFC ≤ULN or ≥50% decrease from baseline at month 7 (95% CI) Median (min, max) % mUFC change from baseline at month 7 Median (min, max) % mUFC change from baseline at month 12 * Primary endpoint using LOCF (last observation carried forward) mUFC: mean urinary free cortisol; ULN: upper limit of normal; CI: confidence interval
Postotak bolesnika s: mUFC ≤GGN u 7. mjesecu (95% CI) * mUFC ≤GGN i bez prethodnog povećanja doze u 7. mjesecu (95% CI) mUFC ≤GGN ili smanjenje ≥50% u odnosu na početnu vrijednost u 7. mjesecu (95% CI) Medijan (min, maks)% promjene mUFC-a u odnosu na početnu vrijednost u 7. mjesecu Medijan (min, maks) % promjene mUFC-a u odnosu na početnu vrijednost u 12. mjesecu * Mjera primarnog ishoda koristeći LOCF (eng. last observation carried forward) mUFC: srednji slobodni kortizol u urinu; GGN: gornja granica normale; CI: interval pouzdanosti
A few cases of concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN have been observed with the subcutaneous formulation, however not in patients treated with pasireotide intramuscular use.
Bilo je opaženo nekoliko slučajeva istodobnih povišenja ALT-a većih od 3 x GGN i bilirubina većih od 2 x GGN uz supkutanu formulaciju, ali ne u bolesnika liječenih pasireotidom intramuskularno.
(ciclosporin); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low
(ciklosporin), - lijekove koji se koriste za liječenje razina šećera u krvi koje su previsoke (kao kod šećerne bolesti) ili preniske (hipoglikemija), kao što su:
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
The safety profile of Signifor was consistent with the somatostatin analogue class, except for the occurrence of hypocortisolism and degree of hyperglycaemia.
Sigurnosni profil Signifora bio je dosljedan sa skupinom analoga somatostatina, osim kad je riječ o pojavi hipokortizolizma i stupnju hiperglikemije.
Pasireotide is metabolically highly stable and in vitro data show that pasireotide is not a substrate, inhibitor or inducer of CYP450.
Pasireotid je metabolički visoko stabilan, a in vitro podaci pokazuju da pasireotid nije supstrat, inhibitor ili induktor CYP450.
In acromegaly patients elevated fasting glucose level was the most frequently reported grade 3/4 laboratory abnormality in the two phase III studies.
U bolesnika s akromegalijom povišena razina glukoze natašte bila je najčešće prijavljena laboratorijska abnormalnost stupnja 3/4 u dva ispitivanja faze III.
The recommended initial dose for patients with moderate hepatic impairment (Child Pugh B) is 0.3 mg twice a day (see section 5.2).
Preporučena početna doza za bolesnike s umjerenim oštećenjem jetre (Child Pugh B) iznosi 0,3 mg dvaput na dan (vidjeti dio 5.2).
In healthy volunteers, pasireotide intramuscular use is widely distributed with large apparent volume of distribution (Vz/F >100 litres).
U zdravih dobrovoljaca pasireotid primijenjen intramuskularno ima opsežnu distribuciju uz veliki volumen distribucije (Vz/F >100 litara).
Based on in vitro data pasireotide is not a substrate of the efflux transporter BCRP (breast cancer resistance protein) nor of the influx transporters OCT1 (organic cation transporter 1), OATP (organic anion-transporting polypeptide) 1B1, 1B3 or 2B1.
Na temelju in vitro podataka pasireotid nije supstrat BCRP transportera za izbacivanje (engl. breast cancer resistance protein - protein rezistencije raka dojke) niti transportera za ubacivanje OCT1 (engl. organic cation transporter 1 - transporter organskih kationa 1), OATP (engl. organic anion-transporting polypeptide - polipeptid koji transportira organske anione ) 1B1, 1B3 ili 2B1.
- Abnormal blood test results (sign of high level of creatine phosphokinase, glycosylated haemoglobin, lipase in the blood) - Hair loss
- Poremećeni rezultati krvnih pretraga (znak visoke razine kreatin fosfokinaze, glikiranog hemoglobina, lipaze u krvi) - Gubitak kose
All cases of concurrent elevations were identified within ten days of initiation of treatment with Signifor.
Svi slučajevi istodobnih povišenja bili su utvrđeni u roku od deset dana od početka liječenja Signiforom.
Dose reductions or discontinuation of treatment with pasireotide due to hyperglycaemia were infrequent in clinical studies with pasireotide.
Smanjenja doze ili prekidi terapije pasireotidom zbog hiperglikemije nisu bili učestali u kliničkim ispitivanjima s pasireotidom.
Prepare the injection site with an alcohol wipe.
Pripremite mjesto primjene injekcije alkoholnom maramicom.
Additionally, tolerability and repeated dose toxicity studies were conducted with pasireotide via the intramuscular route.
Uz to, ispitivanja podnošljivosti i toksičnosti ponovljenih doza provedena su s pasireotidom primijenjenim intramuskularno.
Management of suspected adverse reactions or over-response to treatment (IGF-1 < lower limit of normal) may require temporary dose reduction of Signifor.
Zbrinjavanje u slučaju sumnje na nuspojave ili prekomjernog odgovora na liječenje (IGF-1 < donje granice normale) moglo bi zahtijevati privremeno smanjenje doze Signifora.
The percentage of patients achieving biochemical control, including those patients with IGF-1 <LLN was 25.9% in the pasireotide intramuscular use group and 0% in the octreotide intramuscular use group.
Postotak bolesnika koji su postigli biokemijsku kontrolu, uključujući one bolesnike s IGF-1 <DGN bio je 25,9% u skupini koja je primala pasireotid intramuskularno i 0% u skupini koja je primala oktreotid intramuskularno.
In the pivotal study with patients who did not receive prior medical treatment, the proportion of patients who required commencement of anti-diabetic therapy during the study was 36% in the Signifor arm compared to 4.4% in the active control arm.
U ključnom ispitivanju s bolesnicima koji prethodno nisu primali terapiju lijekovima, udio bolesnika u kojih je bilo potrebno započeti terapiju antidijabetikom tijekom ispitivanja bio je 36% u skupini koja je primala Signifor u usporedbi s 4,4% u skupini s aktivnom kontrolom.
Common Toxicity Criteria (CTC) Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Nuspojave stupnja 3 i 4 prema Zajedničkim kriterijima toksičnosti (CTC) bile su uglavnom povezane s hiperglikemijom.
Remove the packaging from the vial adapter by lifting it straight up as shown.
Uklonite pakiranje s nastavka za bočicu podizanjem prema gore kako je prikazano.
Decreases were also demonstrated by the overall percentage of change in mean and median UFC levels at month 6 and 12 as compared to baseline values (see Table 3).
Smanjenja su bila dokazana i ukupnim postotkom promjene u srednjoj vrijednosti i medijanu razina UFC-a u 6. i 12. mjesecu u usporedbi s početnim vrijednostima (vidjeti Tablicu 3).
Decreased total body clearance and increased pharmacokinetic exposures have been seen with increasing age.
Kod starije dobi uočeni su smanjeni ukupni tjelesni klirens i povećana farmakokinetička izloženost.
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.
Liječenje odraslih bolesnika s akromegalijom kod kojih kirurški zahvat nije moguć ili nije postigao izlječenje te koji nisu odgovarajuće kontrolirani terapijom s drugim analogom somatostatina.