natgillin/translations-raw huggingface dataset:
Following multiple monthly doses, pasireotide intramuscular use demonstrates approximately dose-proportional pharmacokinetic exposures in the dose range of 10 mg to 60 mg every 4 weeks.
Po več mesečnih odmerkih je farmakokinetična izpostavljenost pasireotidu za intramuskularno uporabo približno sorazmerna z višino odmerka v okviru odmerjanja od 10 mg do 60 mg vsake 4 tedne.
Note: If not used within 24 hours, the injection kit can be returned to the fridge.
Opomba: Če kompleta niste uporabili v roku 24 ur, ga lahko ponovno shranite v hladilnik.
Bradycardia has been reported with the use of pasireotide (see section 4.8).
Pri uporabi pasireotida so poročali o bradikardiji (glejte poglavje 4.8).
In the event of documented hypocortisolism, temporary exogenous steroid (glucocorticoid) replacement therapy and/or dose reduction or interruption of Signifor therapy may be necessary.
V primeru dokazanega hipokortizolizma je v nekaterih primerih treba začasno uvesti nadomestno eksogeno steroidno (glukokortikoidno) zdravljenje in/ali znižati oziroma prekiniti odmerjanje zdravila Signifor.
Signifor should not be used in patients with severe hepatic impairment (Child Pugh C) (see sections 4.3 and 4.4).
Zdravila Signifor se ne sme uporabljati pri bolnikih s hudo okvaro jeter (Child Pugh stopnje C) (glejte poglavji 4.3 in 4.4).
The efficacy of pasireotide intramuscular use has been demonstrated in two phase III, multicentre studies in acromegaly patients and in one phase III, multicentre study in Cushing's disease patients.
Učinkovitost pasireotida za intramuskularno uporabo so dokazali v dveh multicentričnih študijah faze III pri bolnikih z akromegalijo in v eni multicentrični študiji faze III pri bolnikih s Cushingovo boleznijo.
Maximum allowed dose was 60 mg for pasireotide intramuscular use and 30 mg for octreotide intramuscular use.
Najvišji dovoljeni odmerek je bil 60 mg za pasireotid za intramuskularno uporabo in 30 mg za oktreotid za intramuskularno uporabo.
Three-quarters of patients had previously been treated with octreotide intramuscular use and a quarter with lanreotide deep subcutaneous injection.
Tri četrtine bolnikov je predhodno prejemalo oktreotid za intramuskularno uporabo, ena četrtina pa lanreotid za globoko subkutano injiciranje.
If you interrupt your treatment with Signifor your cortisol level may increase again and your symptoms may come back.
Če prekinete zdravljenje z zdravilom Signifor, se vam lahko spet zviša raven kortizola, simptomi bolezni pa se lahko povrnejo.
If you are pregnant or think that you may be, it is important to tell your doctor who will discuss with you whether you can use Signifor during your pregnancy.
Če ste noseči ali mislite, da bi lahko bili, je pomembno, da to poveste zdravniku in se z njim pogovorite, ali lahko uporabljate zdravilo Signifor med nosečnostjo ali ne. - V času uporabe zdravila Signifor ne smete dojiti.
81 patients were crossed over from octreotide intramuscular use to pasireotide intramuscular use, and 38 patients were crossed over from pasireotide intramuscular use to octreotide intramuscular use.
81 bolnikov je prešlo z intramuskularne uporabe oktreotida na intramuskularno uporabo pasireotida, 38 bolnikov pa je prešlo z intramuskularne uporabe pasireotida na intramuskularno uporabo oktreotida.
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.
Če se sočasni uporabi zdravila Signifor za intramuskularno uporabo in antikoagulantov, ki so derivati kumarina ali heparina, ni mogoče izogniti, je treba bolnike redno spremljati glede sprememb koagulacijskih parametrov (PČ in PTČ) in ustrezno prilagajati odmerke antikoagulantov.
It is therefore necessary to monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyperkalaemia, hyponatraemia, hypoglycaemia).
Iz tega razloga je treba spremljati bolnika in ga poučiti o znakih in simptomih, ki so povezani s hipokortizolizmom (na primer šibkost, utrujenost, anoreksija, navzea, bruhanje, hipotenzija, hiperkaliemija, hiponatriemija, hipoglikemija).
Results are the meanSEM of IC50 values expressed as nmol/l.
Rezultati so navedeni kot povprečna vrednost  standardna napaka ocene povprečja (SEM) vrednosti IC50 in izraženi v nmol/l.
Overall reductions in these parameters were observed in patients with full and partial mean UFC control but tended to be greater in patients with normalised UFC.
V celoti je bilo znižanje vrednosti navedenih parametrov opazno pri povsem in deloma urejenih bolnikih glede na povprečno vrednost UFC, vendar je bilo nekoliko večje pri bolnikih, pri katerih je prišlo do normalizacije vrednosti UFC.
The control may be too strong and you may experience signs or symptoms associated with a lack of cortisol, such as extreme weakness, tiredness, weight loss, nausea, vomiting or low blood pressure.
Pri tem lahko deluje premočno in lahko pride do znakov in simptomov, ki so povezani s pomanjkanjem kortizola, kot so izredna šibkost, utrujenost, zmanjšanje telesne mase, občutek slabosti, bruhanje ali nizek krvni tlak.
The dose may be increased to a maximum of 60 mg for patients whose growth hormone (GH) and/or insulin-like growth factor-1 (IGF-1) levels are not fully controlled after 3 months of treatment with Signifor at 40 mg.
Odmerek se lahko zviša na največ 60 mg pri bolnikih, pri katerih koncentraciji rastnega hormona in/ali insulinu podobnega rastnega faktorja-1 (IGF-1) nista povsem urejeni po 3 mesecih zdravljenja z zdravilom Signifor v odmerku 40 mg.
If you forgot to inject a dose of Signifor, simply inject the next dose at the scheduled time.
Če ste si pozabili injicirati odmerek zdravila Signifor, si preprosto injicirajte naslednji odmerek po razporedu.
Population pharmacokinetic analysis suggests that based on Cmax and AUC, 90% of steady state in Cushing's disease patients is reached after approximately 1.5 and 15 days, respectively.
Analiza populacijske farmakokinetike kaže, da na osnovi Cmax in AUC pride pri 90 % bolnikov s Cushingovo boleznijo do stanja dinamičnega ravnovesja po približno 1,5 oziroma 15 dneh.
Table 5 Key results - phase III study in Cushing's disease patients (intramuscular formulation)
Preglednica 5 Glavni rezultati - študija faze III pri bolnikih s Cushingovo boleznijo (intramuskularna oblika zdravila)
It is particularly important that you mention any of the following medicines: - ciclosporin (used in organ transplantation to reduce the activity of the immune system); - medicines to treat blood sugar levels that are too high (as in diabetes) or too low (hypoglycaemia), such as:
Posebej pomembno je, da zdravniku poveste, če uporabljate katero od naslednjih zdravil: - ciklosporin (ki ga uporabljamo po presaditvah organov za zaviranje delovanja imunskega sistema); - zdravila za urejanje ravni krvnega sladkorja, kadar so previsoke (kot pri sladkorni bolezni) ali prenizke (hipoglikemija), kot so:
Baseline demographics were well balanced between the two randomised dose groups and consistent with the epidemiology of the disease.
Izhodiščni demografski podatki so bili v obeh randomiziranih skupinah enakomerno razporejeni in skladni z epidemiologijo bolezni.
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.
V klinični študiji z enkratnim subkutanim odmerkom 900 µg pasireotida pri osebah z okvaro ledvic, okvara blage, zmerne ali hude stopnje ali končna odpoved ledvic ni pomembno vplivala na izpostavljenost celotnemu pasireotidu v plazmi.
The patient should be monitored for response and tolerability and further dose adjustments may be needed.
Bolnika je treba spremljati glede odziva na zdravljenje in prenašanja zdravila in po potrebi prilagoditi odmerjanje.
In patients treated with pasireotide intramuscular use in whom reductions in GH and IGF-1 levels were observed, these changes occurred during the first 3 months of treatment and were maintained up to week 24.
Pri bolnikih, ki so prejemali pasireotid za intramuskularno uporabo in pri katerih so opažali znižanje vrednosti rastnega hormona in faktorja IGF-1, je do teh sprememb prišlo v prvih 3 mesecih zdravljenja, ohranile pa so se tudi do konca 24. tedna zdravljenja.
Especially, tell your doctor if you are using: - medicines to treat irregular heartbeat, such as medicines containing disopyramide,
Obvestite svojega zdravnika zlasti če uporabljate: - zdravila za zdravljenje nepravilnega srčnega ritma, kot so zdravila, ki vsebujejo dizopiramid,
Liver tests
Jetrni testi
Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg twice daily.
Pri bolnikih, ki tem kriterijem niso ustrezali, so zdravljenje razkrili in jim povečali odmerek za 0,3 mg dvakrat na dan.
• cholinesterase inhibitors (rivastigmine, physostigmine); - medicines to control the balance of electrolytes (potassium, magnesium) in your body.
• zaviralci holinesteraze (rivastigmin, fizostigmin); - zdravila za vzdrževanje ravnovesja elektrolitov (kalija, magnezija) v telesu.
These episodes were sporadic and of single occurrence with no clinical consequence observed.
Do navedenega pojava je prihajalo sporadično in po enkrat pri posameznem bolniku, pri tem pa niso opažali nobenih kliničnih posledic.
If side effects occur your doctor may temporarily reduce your dose by 0.3 mg per injection.
Če pride do neželenih učinkov, vam lahko zdravnik začasno zniža odmerek za 0,3 mg pri vsakem injiciranju.
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.
V študiji so dosegli primarni cilj učinkovitosti v skupini z odmerkom 0,9 mg dvakrat na dan, saj je bila pri tej skupini spodnja meja 95-odstotnega intervala zaupanja višja od vnaprej določene meje 15 %.
lumefantrine); - medicines to control blood pressure such as:
- zdravila za uravnavanje krvnega tlaka, kot so:
Withdraw the needle from the injection site and activate the safety guard.
Izvlecite iglo z mesta injiciranja in aktivirajte varnostni ščitnik.
DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
NE UPORABLJAJTE je, če je poškodovana ali če je tekočina v njej videti motna ali vsebuje delce.
If you are using medicine to treat a heart condition, your doctor may also need to adjust its dosage.
Če uporabljate zdravila za srce, vam bo moral zdravnik morda prilagoditi tudi odmerjanje teh zdravil.
These reactions resolved spontaneously and required no intervention.
Navedene reakcije so spontano izzvenele in zaradi njih ni bil potreben dodaten zdravstveni poseg.
During your treatment with Signifor: - Signifor may cause your blood sugar to increase.
V času zdravljenja z zdravilom Signifor - Zdravilo Signifor vam lahko zviša koncentracijo sladkorja v krvi.
This is a long-term treatment, possibly lasting for years.
Kako dolgo je treba uporabljati zdravilo Signifor Gre za dolgotrajno zdravljenje, ki lahko traja tudi več let.
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 varnostni ščitnik, da pokrije iglo, in sicer na enega od dveh prikazanih načinov: - bodisi pritisnite zglob varnostnega ščitnika navzdol ob trdo površino (slika A), - ali pa zglob potisnite naprej s prstom
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
V vsaki pogostnostni skupini so neželeni učinki navedeni po padajoči resnosti.
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).
Kakovost življenja v povezavi z zdravjem so ocenjevali s pomočjo za bolezen specifičnih meril o izidih bolezni, ki jih poročajo bolniki (vprašalnik CushingQoL) in meril za splošno kakovost življenja (splošni vprašalnik o zdravju SF-12v2).
Hold the base of the ampoule in one hand.
Z eno roko držite spodnji del ampule.
Injection site reactions were reported in 13.6% of patients enrolled in the phase III study in Cushing's disease.
O reakcijah na mestu injiciranja so poročali pri 13,6 % bolnikov, ki so bili vključeni v študijo faze III pri bolnikih s Cushingovo boleznijo.
FOR DEEP INTRAMUSCULAR INJECTION ONLY.
SAMO ZA GLOBOKO INTRAMUSKULARNO INJICIRANJE.
Recommended procedure: hold the ampoule in an upright position with the coloured dot facing away from you.
Priporočen postopek: ampulo držite v pokončnem položaju tako, da je obarvana pika obrnjena stran od vas.
In patients who developed hyperglycaemia, the condition generally appeared to respond to antidiabetic therapy.
Pri bolnikih, pri katerih se je razvila hiperglikemija, se je le-ta običajno odzvala na zdravljenje z antidiabetiki.
Your doctor may want to monitor your blood sugar and start treatment with or adjust your antidiabetic medicine.
Zdravnik bo morda hotel spremljati vrednosti sladkorja v krvi in vam uvesti zdravljenje s katerim od zdravil za zniževanje krvnega sladkorja oziroma prilagoditi njegovo odmerjanje.
The overall incidence of hyperglycaemia-related adverse reactions was 75.3% (all grades) and 22.7% (CTC Grade 3).
Skupna pogostnost vseh s hiperglikemijo povezanih neželenih učinkov je bila 75,3 % (za vse stopnje) oziroma 22,7 % (za stopnjo 3 po kriterijih CTC).
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.
Jetrno funkcijo je priporočeno spremljati pred začetkom zdravljenja s pasireotidom za intramuskularno uporabo in po prvih dveh do treh tednih, nato pa tri mesece enkrat na mesec.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni, da je “brez natrija”.
Monitoring for an effect on the QTc interval is advisable 21 days after the beginning of the treatment and as clinically indicated thereafter.
Vpliv na interval QTc je priporočeno preveriti 21 dni po začetku zdravljenja in kasneje, kadar je klinično indicirano.
Nearly half of the patients had additional prior medical treatment for acromegaly other than somatostatin analogues.
Približno polovica teh bolnikov je predhodno zaradi akromegalije poleg analogov somatostatina prejemala tudi druga zdravila.
The maximum recommended dose for these patients is 0.6 mg twice a day.
Najvišji priporočeni odmerek za te bolnike je 0,6 mg dvakrat na dan.
Grade 3 adverse reactions were observed in 35.8% of patients and Grade 4 adverse reactions in 2.5% of patients.
Neželene učinke 3. stopnje so opažali pri 35,8 % bolnikov in neželene učinke 4. stopnje pri 2,5 % bolnikov.
Breast-feeding should be discontinued during treatment with Signifor.
Med zdravljenjem z zdravilom Signifor je treba prenehati z dojenjem.
Concomitant administration of pasireotide and ciclosporin may require adjustment of the ciclosporin dose to maintain therapeutic levels.
Pri sočasni uporabi pasireotida in ciklosporina je v nekaterih primerih treba prilagoditi odmerek ciklosporina za vzdrževanje njegove terapevtske ravni.
Embryo toxicity was seen in rats and rabbits at doses that caused maternal toxicity but no teratogenic potential was detected.
Pri podganah in kuncih so pri odmerkih, ki so bili toksični za mater, opažali toksično delovanje na zarodek, teratogenega potenciala pa niso odkrili.
Gently tap the syringe to remove any visible bubbles and expel them from the syringe.
Nežno potrkajte po brizgi, da odstranite morebitne vidne zračne mehurčke in jih iztisnite iz brizge.
A total of 198 patients were randomised to receive pasireotide intramuscular use 40 mg (n=65), pasireotide intramuscular use 60 mg (n=65) or active control (n=68).
Skupno so 198 bolnikov randomizirali tako, da so prejemali pasireotid za intramuskularno uporabo v odmerku 40 mg (n=65), pasireotid za intramuskularno uporabo v odmerku 60 mg (n=65) ali primerjalno zdravilo (n=68).
There are two critical steps in the reconstitution of Signifor.
Rekonstitucija zdravila Signifor vključuje dva kritična koraka.
The adverse reactions in Table 1 include events reported in the pivotal studies with the intramuscular formulation in patients with acromegaly and with Cushing's disease.
Neželeni učinki v preglednici 1 vključujejo dogodke, o katerih so poročali v ključnih študijah oblike za intramuskularno dajanje pri bolnikih z akromegalijo in tistih s Cushingovo boleznijo.
Adverse reactions are listed according to MedDRA primary system organ class.
Neželeni učinki so navedeni po organskih sistemih v skladu s klasifikacijo MedDRA.
ATTENTION: Keep the plunger pressed and shake the vial moderately for a minimum of 30 seconds so that the powder is completely suspended.
OPOZORILO: Bat držite pritisnjen do konca in zmerno stresajte vialo najmanj 30 sekund, tako da se prašek v celoti zmeša z vehiklom.
Table 1 Adverse reactions by preferred term for pasireotide intramuscular use
Preglednica 1 Neželeni učinki pasireotida za intramuskularno uporabo po prednostnih izrazih
Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours.
Komplet naj pred rekonstitucijo stoji na sobni temperaturi najmanj 30 minut, vendar ne več kot 24 ur.
Signifor suspension must only be prepared immediately before administration.
Suspenzijo zdravila Signifor je treba pripraviti šele tik pred dajanjem.
Due to its broad binding profile to somatostatin receptors, pasireotide has the potential to stimulate both hsst2 and hsst5 subtype receptors relevant for inhibition of GH and IGF-1 secretion and therefore to be effective for the treatment of acromegaly.
Zaradi širokega profila vezave na receptorje za somatostatin lahko pasireotid stimulira tako receptorje podvrste hsst2 kot podvrste hsst5, ki so pomembni za zaviranje sproščanja rastnega hormona in faktorja IGF-1, zato je pasireotid lahko učinkovit pri zdravljenju akromegalije.
Store Signifor ampoules according to the storage conditions listed on the box.
Ampule z zdravilom Signifor shranjujte v skladu z navodili, ki so navedena na škatli.
Preferred injection sites for subcutaneous injections are the top of the thighs and the abdomen (excluding the navel or waistline).
Najprimernejša mesta za subkutano injiciranje so zgornji del stegen in trebuh (razen popka in predela pasu).
Hold the syringe in one hand between two fingers with your thumb at the bottom of the plunger.
Z eno roko primite brizgo tako, da jo držite med dvema prstoma, palec pa nastavite na vrh bata.
IGF-1 mean values at baseline were 2.6, 2.8 and 2.9 x ULN, respectively.
Povprečne izhodiščne koncentracije faktorja IGF-1 so bile 2,6, 2,8 oziroma 2,9 x ZMN.
You should also avoid injections at sites that are sore or where the skin is irritated.
Poleg tega pazite, da si zdravila ne injicirate na mestih, kjer je koža boleča ali vneta.
Grade 3 and 4 adverse reactions were mostly related to hyperglycaemia.
Neželeni učinki 3. in 4. stopnje so bili večinoma povezani s hiperglikemijo.
Important information about some of the ingredients of Signifor Signifor contains less than 1 mmol sodium (23 mg) per dose, which means it is essentially “sodium-free”.
Pomembne informacije o nekaterih sestavinah zdravila Signifor Zdravilo Signifor vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni, da je “brez natrija”.
Further decrease in tumour volume was observed at month 12 after crossover for both treatment groups, and was higher in patients who crossed over to pasireotide intramuscular use (-24.7%) than in patients who crossed over to octreotide intramuscular use (-17.9%).
V obeh študijskih skupinah so 12 mesecev po navzkrižni zamenjavi zdravila opažali nadaljnje zmanjšanje tumorske mase, ki je bilo večje pri bolnikih, ki so prešli na intramuskularno uporabo pasireotida (-24,7 %), kot pri bolnikih, ki so prešli na intramuskularno uporabo oktreotida (-17,9 %).
The eligibility criteria included a mean urinary free cortisol (mUFC) value of between 1.5 and 5 times upper limit of normal (ULN) at screening.
Med kriteriji primernosti za vključitev je bila povprečna vrednost prostega kortizola v urinu (angl. mean urinary free cortisol, mUFC) med 1,5-kratnikom in 5-kratnikom zgornje meje normalnih vrednosti (ZMN) ob presejanju.
Do not inject a double dose of Signifor to make up for a forgotten dose.
Ne injicirajte si dvojnega odmerka zdravila Signifor, če ste pozabili vzeti prejšnji odmerek.
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).
Znižanja so se pokazala tudi pri skupni odstotni spremembi povprečnih in medianih vrednosti UFC po 6 in 12 mesecih v primerjavi z izhodiščnimi vrednostmi (glejte preglednico 3).
The safety profile of pasireotide intramuscular use was largely similar between the acromegaly and Cushing's disease indications.
Varnostni profil pasireotida za intramuskularno uporabo je bil večinoma podoben pri obeh indikacijah, torej pri akromegaliji in Cushingovi bolezni.
Each ampoule contains 1 ml of solution for injection.
Ena ampula vsebuje 1 ml raztopine za injiciranje.
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.
V ključni študiji z bolniki, ki pred tem še niso bili zdravljeni, je delež bolnikov, ki so se morali začeti zdraviti z antidiabetiki v času študije, znašal 36 % v skupini z zdravilom Signifor v primerjavi s 4,4 % v skupini s primerjalnim zdravilom.
Pull the protective cover straight off the needle.
Zaščitni pokrovček potegnite z igle povsem naravnost.
This means that it is injected through a needle into the muscles of your buttocks.
To pomeni, da vam ga bodo z iglo injicirali v mišico na zadnjici.
The human body naturally produces a substance called somatostatin, which blocks the production of certain hormones, including ACTH.
V človeškem telesu normalno nastaja snov, ki jo imenujemo somatostatin in zavira tvorbo določenih hormonov, med drugim tudi hormona ACTH.
Careful monitoring is recommended in patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia or acute myocardial infarction, high-grade heart block, congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation.
Skrbno spremljanje je priporočeno pri bolnikih z boleznimi srca in/ali z dejavniki tveganja za bradikardijo, kot so klinično pomembna bradikardija ali akutni miokardni infarkt v anamnezi, srčni blok visoke stopnje, kongestivno popuščanje srca (funkcijski razred NYHA III ali IV), nestabilna angina pektoris, obstojna ventrikularna tahikardija in ventrikularna fibrilacija.
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 metabolično zelo stabilen in podatki raziskav in vitro kažejo, da ni substrat, zaviralec ali induktor nobenega od pomembnejših encimov CYP450.
How to inject Signifor
Kako injicirati zdravilo Signifor
Use syringes and needles only once.
Vsako brizgo ali iglo lahko uporabite samo enkrat.
The recommended initial dose is 0.6 mg pasireotide by subcutaneous injection twice a day.
Priporočeni začetni odmerek je 0,6 mg pasireotida s subkutano injekcijo dvakrat na dan.
The study met its primary efficacy endpoint for both pasireotide intramuscular use doses.
Primarni cilj opazovanja glede učinkovitosti je bil dosežen pri obeh odmerkih pasireotida za intramuskularno uporabo.