natgillin/translations-raw huggingface dataset:
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. 
Ispitivanje u bolesnika s akromegalijom C2305, bolesnici bez prethodne terapije lijekovima Multicentrično, randomizirano, slijepo ispitivanje faze III bilo je provedeno da bi se ocijenila sigurnost i djelotvornost pasireotida primijenjenog intramuskularno u usporedbi s oktreotidom primijenjenim intramuskularno u bolesnika s aktivnom akromegalijom koji ranije nisu primali terapiju.
- Inflammation of the gallbladder (cholecystitis). 
- Upala žučnog mjehura (kolecistitis).
- Do not use this medicine after the expiry date which is stated on the ampoule label and carton after “EXP”. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici ampule i kutiji iza oznake “EXP/Rok valjanosti”.
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). 
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Signifor u svim podskupinama pedijatrijske populacije u akromegaliji i hipofiznom gigantizmu te u Cushingovoj bolesti ovisnoj o hipofizi, prekomjernoj proizvodnji ACTH-a u hipofizi i hiperadrenokorticizmu ovisnom o hipofizi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor. 
Kod uključivanja u ispitivanje bolesnici su bili randomizirani na primjenu Signifora u dozi od 0,6 mg ili 0,9 mg dvaput na dan.
Holding the vial adapter packaging, position the vial adapter on top of the vial and push it fully down so that it snaps in place, confirmed by a “click”. 
Držeći pakiranje nastavka za bočicu, postavite nastavak za bočicu na vrh bočice i gurnite ga do kraja prema dolje tako da sjedne na svoje mjesto, što ćete znati kad čujete “klik”.
NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
Step 8 
8. korak
It is unknown whether pasireotide is excreted in human milk. 
Nije poznato izlučuje li se pasireotid u majčino mlijeko u ljudi.
The maximum dose of Signifor in Cushing's disease is 40 mg every 4 weeks. 
Maksimalna doza Signifora kod Cushingove bolesti je 40 mg svaka 4 tjedna.
Solvent: clear, colourless to slightly yellow or slightly brown solution. 
Otapalo: bistra, bezbojna do blago žuta ili blago smeđa otopina.
Signifor 10 mg powder and solvent for suspension for injection Signifor 20 mg powder and solvent for suspension for injection Signifor 30 mg powder and solvent for suspension for injection Signifor 40 mg powder and solvent for suspension for injection Signifor 60 mg powder and solvent for suspension for injection pasireotide 
Signifor 10 mg prašak i otapalo za suspenziju za injekciju Signifor 20 mg prašak i otapalo za suspenziju za injekciju Signifor 30 mg prašak i otapalo za suspenziju za injekciju Signifor 40 mg prašak i otapalo za suspenziju za injekciju Signifor 60 mg prašak i otapalo za suspenziju za injekciju
Pasireotide is a novel cyclohexapeptide, injectable somatostatin analogue. 
Pasireotid je novi cikloheksapeptid, analog somatostatina za ubrizgavanje.
Unit packs (all strengths): each unit pack contains 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). 
Jedinična pakiranja (sve jačine): svako jedinično pakiranje sadrži podložak s jednim setom za primjenu injekcije (jedna bočica te, u odvojenom zatvorenom dijelu, jedna napunjena štrcaljka, jedan nastavak za bočicu i jedna igla za injekciju sa zaštitnim mehanizmom).
Somatostatin (SRIF-14) 
Somatostatin (SRIF-14) Pasireotid Oktreotid Lanreotid
- Do not use this medicine after the expiry date which is stated on the carton, vial and pre-filled syringe after “EXP”. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici i napunjenoj štrcaljki iza oznake „Rok valjanosti“/„EXP“.
The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete. 
Relativna bioraspoloživost pasireotida primijenjenog intramuskularno u odnosu na pasireotid primijenjen supkutano je potpuna.
Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in healthy subjects and patients receiving pasireotide in clinical studies. 
Kod uporabe analoga somatostatina bila su prijavljena prolazna povišenja jetrenih enzima koja su također bila uočena u zdravih ispitanika i bolesnika koji su primali pasireotid u kliničkim ispitivanjima.
Pasireotide administered via the subcutaneous route did not affect fertility in male rats but, as expected from the pharmacology of pasireotide, females presented abnormal cycles or acyclicity, and decreased numbers of corpora lutea and implantation sites. 
Pasireotid primijenjen supkutano nije utjecao na plodnost u mužjaka štakora, ali, kako se i očekuje iz farmakologije pasireotida, ženke su imale abnormalne cikluse ili ih nisu imale te su imale smanjene broja žutih tijela i mjesta implantacije.
Remove the packaging from the vial adapter by lifting it straight up. 
Uklonite pakiranje s nastavka za bočicu podizanjem prema gore.
• insulin 
• inzulin
What Signifor looks like and contents of the pack Signifor powder is a slightly yellowish to yellowish powder in a vial. 
Signifor prašak je blago žućkasti do žućkasti prašak u bočici.
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. 
Sigurnosni profil pasireotida koji se primjenjuje intramuskularno bio je dosljedan sa skupinom analoga somatostatina, osim što je uočen veći stupanj i učestalost hiperglikemije uz pasireotid primijenjen intramuskularno.
Available data in rats have shown excretion of pasireotide in milk (see section 5.3). 
Dostupni podaci u štakora pokazuju da se pasireotid izlučuje u mlijeko (vidjeti dio 5.3).
1 vial of powder + 1 pre-filled syringe with 2 ml solvent+ 1 safety-engineered needle + 1 vial adapter. 
1 bočica praška + 1 napunjena štrcaljka s 2 ml otapala+ 1 igla sa zaštitnim mehanizmom + 1 nastavak za bočicu.
Table 1 Adverse reactions by preferred term for pasireotide intramuscular use 
Tablica 1 Nuspojave za pasireotid koji se primjenjuje intramuskularno prema preporučenom izrazu
Pasireotide is eliminated mainly via hepatic clearance (biliary excretion), with a small contribution of the renal route. 
Pasireotid se eliminira putem hepatičkog klirensa (izlučivanje u žuči), pri čemu se mali dio izlučuje putem bubrega.
Table 1 Adverse reactions in the phase III study in Cushing's disease patients 
Tablica 1 Nuspojave u ispitivanju faze III na bolesnicima s Cushingovom bolešću
Signifor is to be administered by deep intramuscular injection by a trained healthcare professional. 
Signifor mora primjenjivati educirani zdravstveni radnik dubokom intramuskularnom injekcijom.
Cholelithiasis is a recognised adverse reaction associated with somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8). 
Kolelitijaza je poznata nuspojava povezana s analozima somatostatina i često se prijavljuje u kliničkim ispitivanjima s pasireotidom (vidjeti dio 4.8).
Diarrhoea, nausea, abdominal pain* 
Proljev, mučnina, bol u abdomenu*
Signifor is intended for subcutaneous use. 
Signifor je namijenjen za potkožnu primjenu.
The recommended starting dose of Signifor in acromegaly is 40 mg every 4 weeks. 
Preporučena početna doza Signifora kod akromegalije je 40 mg svaka 4 tjedna.
In the acromegaly studies, the events were comparable between pasireotide intramuscular use and octreotide intramuscular use treated patients, and were less frequent in inadequately controlled patients compared to medically naïve patients. 
U ispitivanjima u bolesnika s akromegalijom događaji su bili usporedivi između bolesnika liječenih pasireotidom primijenjenim intramuskularno i onih liječenih oktreotidom primijenjenim intramuskularno te su bili manje učestali u neodgovarajuće kontroliranih bolesnika u usporedbi s bolesnicima koji nisu ranije primali terapiju lijekovima.
The usual starting dose of Signifor in Cushing's disease is 10 mg every 4 weeks. 
Uobičajena početna doza Signifora kod Cushingove bolesti je 10 mg svaka 4 tjedna.
Hyperglycaemia, diabetes mellitus 
Hiperglikemija, šećerna bolest
The development of hyperglycaemia appears to be related to decreases in secretion of insulin (particularly in the post-dose period) and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]). 
Razvoj hiperglikemije je čini se povezan sa smanjenjima u izlučivanju inzulina (osobito u razdoblju nakon primanja doze) i inkretinskih hormona (tj. glukagonu sličnog peptida-1 [engl. glucagon-like peptide-1, GLP-1] i inzulinotropnog polipeptida ovisnog o glukozi ([engl. glucose-dependent insulinotropic polypeptide, GIP]).
Signifor intramuscular use 60 mg 
Signifor primijenjen intramuskularno 60 mg
Signifor intramuscular use 40 mg 
Signifor primijenjen intramuskularno 40 mg
Solvent: carmellose sodium, mannitol, poloxamer 188, water for injections. 
Otapalo: karmelozanatrij, manitol, poloksamer 188, voda za injekcije.
GH<2.5 μg/l and normalised IGF-1* 
GH<2,5 μg/l i normalizirani IGF-1*
Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue 
Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Proljev - Mučnina - Bol u abdomenu - Umor
Included in the injection kit: a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″) 
Uključeno u set za primjenu injekcije: a Jedna bočica koja sadrži prašak b Jedna napunjena štrcaljka koja sadrži otapalo c Jedan nastavak za bočicu za rekonstituciju lijeka d Jedna igla (20G x 1,5″) za injekciju, sa zaštitnim mehanizmom
Solvent for Signifor 
Otapalo za Signifor
Liver tests 
Testovi funkcije jetre
Transient elevations in liver enzymes have been reported with the use of somatostatin analogues and were also observed in patients receiving pasireotide in clinical studies. 
Kod uporabe analoga somatostatina bila su prijavljena prolazna povišenja jetrenih enzima koja su također bila uočena u bolesnika koji su primali pasireotid u kliničkim ispitivanjima.
The development of hyperglycaemia appears to be related to decreases in secretion of insulin and of incretin hormones (i.e. glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]). 
Razvoj hiperglikemije je čini se povezan sa smanjenjima u izlučivanju inzulina i inkretinskih hormona (tj. glukagonu sličnog peptida-1 [engl. glucagon-like peptide-1, GLP-1] i inzulinotropnog polipeptida ovisnog o glukozi ([engl. glucose-dependent insulinotropic polypeptide, GIP]).
Step 1: 
Korak 1:
Step 8: 
Korak 8:
Powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50). 
Prašak: poli(D,L-laktid-ko-glikolid) (50-60:40-50), poli(D,L-laktid-ko-glikolid) (50:50).
In the acromegaly study C2305, the proportion of patients with newly occurring notable QT/QTc intervals was comparable between pasireotide intramuscular use and octreotide intramuscular use groups up to crossover, with few notable outlying values. 
U ispitivanju u bolesnika s akromegalijom C2305 udio bolesnika s novonastalim zamjetnim QT/QTc intervalima bio je usporediv između skupina koje su primale pasireotid primijenjen intramuskularno i onih koje su primale oktreotid primijenjen intramuskularno sve do ukrižene zamjene ispitivanog lijeka, uz vrlo malo zamjetnih stršećih vrijednosti.
Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with Signifor (see section 4.6). 
Bolesnice reproduktivne dobi potrebno je upozoriti da tijekom liječenja Signiforom, ako je potrebno, koriste djelotvornu kontracepciju (vidjeti dio 4.6).
Glucose metabolism disorders 
Poremećaji metabolizma glukoze
Screw the safety injection needle onto the syringe. 
Zavrtanjem pričvrstite iglu za injekciju sa zaštitnim mehanizmom na štrcaljku.
Month 12 * Includes one patient with significant outlying results who had a percent change from baseline of 
* Uključuje jednog bolesnika sa značajnim izraženim rezultatima koji je imao postotak promjene od početne vrijednosti od +542,2%.
Poly(D,L-lactide-co-glycolide) (50-60:40-50) Poly(D,L-lactide-co-glycolide) (50:50) 
Poli(D,L-laktid-ko-glikolid) (50-60:40-50) Poli(D,L-laktid-ko-glikolid) (50:50)
pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone); - medicines to treat hay fever and other allergies (terfenadine, astemizole, mizolastine); - medicines used in the prevention or treatment of malaria (chloroquine, halofantrine, 
pimozid, haloperidol, tiaprid, amisulpirid, sertindol, metadon); - lijekove koji liječe peludnu groznicu i druge alergije (terfenadin, astemizol, mizolastin); - lijekove koji se koriste u sprečavanju ili liječenju malarije (klorokin, halofantrin, lumefantrin); - lijekove za kontroliranje krvnog tlaka, kao što su:
- In the solvent: carmellose sodium, mannitol, poloxamer 188, water for injections. 
U otapalu: karmelozanatrij, manitol, poloksamer 188, voda za injekcije.
a One vial containing the powder b One pre-filled syringe containing the solvent c One vial adapter for medicinal product reconstitution d One safety injection needle (20G x 1.5″) 
a Jedna bočica koja sadrži prašak b Jedna napunjena štrcaljka koja sadrži otapalo c Jedan nastavak za bočicu za rekonstituciju lijeka d Jedna igla (20G x 1,5″) za injekciju, sa zaštitnim mehanizmom
One-point-cut colourless, type I glass ampoule containing 1 ml of solution. 
Bezbojna staklena ampula (staklo tipa I) sa zarezom na mjestu loma koja sadrži 1 ml otopine.
Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3). 
Ispitivanja na štakorima u kojih se pasireotid primjenjivao supkutano pokazala su učinke na ženske reproduktivne parametre (vidjeti dio 5.3).
In healthy volunteers, pasireotide is rapidly absorbed and peak plasma concentration is reached within 0.25-0.5 h. Cmax and AUC are approximately dose-proportional following administration of single and multiple doses. 
U zdravih dobrovoljaca pasireotid se brzo apsorbira, a vršna koncentracija u plazmi postiže se u roku od 0,25-0,5 h.
Powder and solvent for suspension for injection 
Prašak i otapalo za suspenziju za injekciju
For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”. 
Za informacije o uputama za uporabu, molimo vidjeti kraj upute o lijeku
Diarrhoea, abdominal pain, nausea 
Proljev, bol u abdomenu, mučnina
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. 
U ispitivanju interakcija među lijekovima u zdravih dobrovoljaca ispitivan je utjecaj P-gp inhibitora verapamila na farmakokinetiku supkutano primijenjenog pasireotida.
PRE-FILLED SYRINGE LABEL 
NALJEPNICA ZA NAPUNJENU ŠTRCALJKU
No clinical studies in subjects with liver impairment have been performed with pasireotide intramuscular use. 
Nisu provedena klinička ispitivanja s pasireotidom primijenjenim intramuskularno u ispitanika s oštećenjem jetre.
GH<2.5 μg/l * Primary endpoint (patients with IGF-1< lower limit of normal (LLN) were not considered “responders”). 
* Mjera primarnog ishoda (bolesnici s IGF-1 ispod donje granice normale (DGN) nisu se smatrali bolesnicima s odgovorom).
INSTRUCTIONS FOR USE OF SIGNIFOR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 
UPUTE ZA PRIMJENU SIGNIFOR PRAŠKA I OTAPALA ZA SUSPENZIJU ZA INJEKCIJU
What Signifor looks like and contents of the pack Signifor solution for injection is a clear, colourless solution in an ampoule. 
Signifor otopina za injekciju je bistra, bezbojna otopina u ampuli.
Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3). 
Ispitivanja na životinjama u kojima se pasireotid primjenjivao supkutano pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients. 
U bolesnika s akromegalijom poremećaji probavnog sustava bili su manje učestali u neodgovarajuće kontroliranih bolesnika u usporedbi s bolesnicima koji nisu ranije primali terapiju lijekovima.
Glycosylated haemoglobin increased 
Povišenje glikiranog hemoglobina
How to use Signifor 
Kako primjenjivati Signifor
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. 
U bolesnika s Cushingovom bolešću povišene razine FPG-a bile su najčešće prijavljene laboratorijske abnormalnosti CTC stupnja 3 (14,7% bolesnika) u ispitivanju G2304 faze III; nije bilo prijavljenih slučajeva stupnja 4. Srednja povećanja HbA1c bila su manje izražena u bolesnika s normalnom glikemijom kod uključenja u ispitivanje u usporedbi s pred-dijabetičkim ili dijabetičkim bolesnicima.
In a human ADME study 55.9±6.63% of the radioactive pasireotide subcutaneous dose was recovered over the first 10 days after administration, including 48.3±8.16% of the radioactivity in faeces and 7.63±2.03% in urine. 
U ADME (apsorpcija, distribucija, metabolizam i eliminacija) ispitivanju u ljudi 55,9±6,63% radioaktivne doze supkutanog pasireotida bilo je detektirano tijekom prvih 10 dana nakon primjene, uključujući 48,3±8,16% radioaktivnosti u stolici i 7,63±2,03% u mokraći.
Tartaric acid Sodium hydroxide Water for injections 
6.1 Popis pomoćnih tvari manitol tartaratna kiselina natrijev hidroksid voda za injekcije
You may experience yellowing of the skin, dark urine, 
Možete primijetiti žutilo kože, tamnu mokraću, blijede stolice i svrbež.
- Gallstones. 
- Žučni kamenci.
Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 3 (2.0%) and 4 patients (2.7%), respectively. 
Hiperglikemija kao nuspojava dovela je do prekida ispitivanja u 3 (2,0%) bolesnika, a šećerna bolest u 4 (2,7%) bolesnika.
Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection 
Signifor 0,3 mg otopina za injekciju Signifor 0,6 mg otopina za injekciju Signifor 0,9 mg otopina za injekciju
In a human ADME study 55.9±6.63% of the radioactive dose was recovered over the first 10 days after administration, including 48.3±8.16% of the radioactivity in faeces and 7.63±2.03% in urine. 
U ADME (apsorpcija, distribucija, metabolizam i eliminacija) ispitivanju u ljudi 55,9±6,63% radioaktivne doze bilo je detektirano tijekom prvih 10 dana nakon primjene, uključujući 48,3±8,16% radioaktivnosti u stolici i 7,63±2,03% u mokraći.
Slowly push the plunger all the way down to transfer all the solvent in the vial. 
Polako gurnite klip do kraja kako biste prenijeli cjelokupno otapalo u bočicu.
Available data in rats in which pasireotide was administered via the subcutaneous route have shown excretion of pasireotide in milk (see section 5.3). 
Dostupni podaci u štakora u kojih se pasireotid primjenjivao supkutano pokazuju da se pasireotid izlučuje u mlijeko (vidjeti dio 5.3).
If you have any questions, contact your doctor, nurse or pharmacist. 
Ako imate ikakvih pitanja, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
Signifor 20 mg: each vial contains 20 mg pasireotide (as pasireotide pamoate). 
Signifor 20 mg: svaka bočica sadrži 20 mg pasireotida (u obliku pasireotidpamoata).
- The other ingredients are: - In the powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), 
- Drugi sastojci su: U prašku: poli(D,L-laktid-ko-glikolid) (50-60:40-50), poli(D,L-laktid-ko-glikolid)
Treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. 
Liječenje odraslih bolesnika s Cushingovom bolešću kod kojih kirurški zahvat nije moguć ili kod kojih kirurški zahvat nije uspio.
Step 9: 
Korak 9:
AMPOULE LABEL 
NALJEPNICA ZA AMPULU
Signifor 0.9 mg solution for injection EU/1/12/753/009-0012 
Signifor 0,9 mg otopina za injekciju EU/1/12/753/009-0012
It is also used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed. 
Primjenjuje se i za liječenje Cushingove bolesti u odraslih bolesnika kod kojih kirurški zahvat nije moguć ili kod kojih kirurški zahvat nije uspio.
Remove the cover from the needle. 
Skinite zaštitni poklopac s igle.
Mild transient elevations in aminotransferases are commonly observed in patients treated with pasireotide. 
U bolesnika liječenih pasireotidom često se opažaju blaga prolazna povišenja aminotransferaza.
Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection pasireotide 
Signifor 0,3 mg otopina za injekciju Signifor 0,6 mg otopina za injekciju Signifor 0,9 mg otopina za injekciju pasireotid
1 pre-filled syringe with 2 ml solvent 1 safety-engineered needle 1 vial adapter 
1 napunjena štrcaljka s 2 ml otapala 1 igla sa zaštitnim mehanizmom 1 nastavak za bočicu
Signifor 0.6 mg solution for injection EU/1/12/753/005-008 
Signifor 0,6 mg otopina za injekciju EU/1/12/753/005-008
Remove the cap from the syringe pre-filled with solvent and screw the syringe onto the vial adapter. 
Uklonite zatvarač sa štrcaljke napunjene otapalom i zavrtanjem pričvrstite štrcaljku na nastavak za bočicu.
Signifor is intended for intramuscular use. 
Signifor je namijenjen za primjenu u mišić.
Hyperglycaemia and, less frequently, hypoglycaemia, were observed in subjects participating in clinical studies with pasireotide (see section 4.8). 
U ispitanika koji su sudjelovali u kliničkim ispitivanjima s pasireotidom bile su opažene hiperglikemija i, manje učestalo, hipoglikemija (vidjeti dio 4.8).
How to store Signifor 
Kako čuvati Signifor
Vomiting, abdominal pain upper 
Povraćanje, bol u gornjem dijelu abdomena
It is used to treat Cushing's disease in adult patients for whom surgery is not an option or for whom surgery has failed. 
Primjenjuje se za liječenje Cushingove bolesti u odraslih bolesnika kod kojih kirurški zahvat nije moguć ili kod kojih kirurški zahvat nije uspio.
Multipack: 3 packs of 1 injection kit 
Prašak i otapalo za suspenziju za injekciju Višestruko pakiranje: 3 pakiranja s po 1 setom za primjenu injekcije
increased appetite with weight loss, tiredness. 
Možete osjetiti pretjeranu žeđ, povećano mokrenje, povećani apetit uz gubitak težine, umor.
Signifor 60 mg powder and solvent for suspension for injection EU/1/12/753/016-017 
Signifor 60 mg prašak i otapalo za suspenziju za injekciju EU/1/12/753/016-017
Within each system organ class, adverse reactions are ranked by frequency. 
Unutar svakog organskog sustava nuspojave su razvrstane po učestalosti.
Signifor 20 mg powder and solvent for suspension for injection One vial contains 20 mg pasireotide (as pasireotide pamoate). 
Signifor 20 mg prašak i otapalo za suspenziju za injekciju Jedna bočica sadrži 20 mg pasireotida (u obliku pasireotidpamoata).
Signifor 0.3 mg solution for injection EU/1/12/753/001-004 
Signifor 0,3 mg otopina za injekciju EU/1/12/753/001-004