FrancophonIA/ELRC3.0 huggingface dataset:
English: Most patients (83.3%) had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
Croatian: Većina bolesnika (83,3%) imala je perzistentnu ili rekurentnu Cushingovu bolest, a u nekoliko bolesnika (≤5%) u svakoj od terapijskih skupina prethodno je primijenjeno zračenje hipofize.
English: Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4).
Croatian: Kod bolesnika liječenih Signiforom preporučuje se praćenje razina glukoze u krvi (vidjeti dio 4.4).
English: (hypoglycaemia); - heart problems such as a recent heart attack, congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or sudden and oppressive chest pain (usually felt as pressure, heaviness, tightening, squeezing or aching across the chest); - a heart rhythm disorder, such as an irregular heartbeat or an abnormal electrical signal called
Croatian: (hipoglikemija), - srčane probleme kao što su nedavni srčani udar, kongestivno zatajenje srca (vrsta srčane bolesti kod koje srce ne može pumpati dovoljno krvi po tijelu) ili iznenadna i teška bol u grudnom košu
English: The recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Croatian: Preporučena početna doza za liječenje Cushingove bolesti je 10 mg pasireotida dubokom intramuskularnom injekcijom svaka 4 tjedna.
English: Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval, such as class Ia antiarrhythmics (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmics (e.g. amiodarone, dronedarone, sotalol, dofetilide, ibutilide), certain antibacterials (intravenous erythromycin, pentamidine injection, clarithromycin, moxifloxacin), certain antipsychotics (e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, tiapride, amisulpride, sertindole, methadone), certain antihistamines (e.g. terfenadine, astemizole, mizolastine), antimalarials (e.g. chloroquine, halofantrine, lumefantrine), certain antifungals (ketoconazole, except in shampoo) (see also section 4.4).
Croatian: Pasireotid treba oprezno koristiti kod bolesnika koji istodobno primaju lijekove koji produžuju QT interval, kao što su antiaritmici klase Ia (npr. kinidin, prokainamid, dizopiramid), antiaritmici klase III (npr. amiodaron, dronedaron, sotalol, dofetilid, ibutilid), određeni antibiotici (intravenski eritromicin, injekcija pentamidina, klaritromicin, moksifloksacin), određeni antipsihotici (npr. klorpromazin, tioridazin, flufenazin, pimozid, haloperidol, tiaprid, amisulpirid, sertindol, metadon), određeni antihistaminici (npr. terfenadin, astemizol, mizolastin), antimalarici (npr. klorokin, halofantrin, lumefantrin), određeni antimikotici (ketokonazol, osim u šamponu) (vidjeti također dio 4.4).
English: Signifor is to be administered subcutaneously by self injection.
Croatian: Signifor se primjenjuje supkutano samoubrizgavanjem.
English: Acromegaly study C2305 patients who had no prior medical treatment A phase III multicentre, randomised, blinded study was conducted to assess the safety and efficacy of pasireotide intramuscular use versus octreotide intramuscular use in medically naïve patients with active acromegaly.
Croatian: 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.
English: - Inflammation of the gallbladder (cholecystitis).
Croatian: - Upala žučnog mjehura (kolecistitis).
English: - Do not use this medicine after the expiry date which is stated on the ampoule label and carton after “EXP”.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici ampule i kutiji iza oznake “EXP/Rok valjanosti”.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population in acromegaly and pituitary gigantism, and in pituitary dependant Cushing's disease, overproduction of pituitary ACTH and pituitary dependant hyperadrenocorticism (see section 4.2 for information on paediatric use).
Croatian: 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).
English: At study entry patients were randomised to receive twice-daily doses of either 0.6 mg or 0.9 mg Signifor.
Croatian: Kod uključivanja u ispitivanje bolesnici su bili randomizirani na primjenu Signifora u dozi od 0,6 mg ili 0,9 mg dvaput na dan.
English: 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”.
Croatian: 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”.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE (S) OF ADMINISTRATION
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: Step 8
Croatian: 8. korak
English: It is unknown whether pasireotide is excreted in human milk.
Croatian: Nije poznato izlučuje li se pasireotid u majčino mlijeko u ljudi.
English: The maximum dose of Signifor in Cushing's disease is 40 mg every 4 weeks.
Croatian: Maksimalna doza Signifora kod Cushingove bolesti je 40 mg svaka 4 tjedna.
English: Solvent: clear, colourless to slightly yellow or slightly brown solution.
Croatian: Otapalo: bistra, bezbojna do blago žuta ili blago smeđa otopina.
English: 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
Croatian: 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
English: Pasireotide is a novel cyclohexapeptide, injectable somatostatin analogue.
Croatian: Pasireotid je novi cikloheksapeptid, analog somatostatina za ubrizgavanje.
English: 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).
Croatian: 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).
English: Somatostatin (SRIF-14)
Croatian: Somatostatin (SRIF-14) Pasireotid Oktreotid Lanreotid
English: - Do not use this medicine after the expiry date which is stated on the carton, vial and pre-filled syringe after “EXP”.
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, bočici i napunjenoj štrcaljki iza oznake „Rok valjanosti“/„EXP“.
English: The relative bioavailability of pasireotide intramuscular use over pasireotide subcutaneous use is complete.
Croatian: Relativna bioraspoloživost pasireotida primijenjenog intramuskularno u odnosu na pasireotid primijenjen supkutano je potpuna.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Remove the packaging from the vial adapter by lifting it straight up.
Croatian: Uklonite pakiranje s nastavka za bočicu podizanjem prema gore.
English: • insulin
Croatian: • inzulin
English: What Signifor looks like and contents of the pack Signifor powder is a slightly yellowish to yellowish powder in a vial.
Croatian: Signifor prašak je blago žućkasti do žućkasti prašak u bočici.
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.
Croatian: 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.
English: Available data in rats have shown excretion of pasireotide in milk (see section 5.3).
Croatian: Dostupni podaci u štakora pokazuju da se pasireotid izlučuje u mlijeko (vidjeti dio 5.3).
English: 1 vial of powder + 1 pre-filled syringe with 2 ml solvent+ 1 safety-engineered needle + 1 vial adapter.
Croatian: 1 bočica praška + 1 napunjena štrcaljka s 2 ml otapala+ 1 igla sa zaštitnim mehanizmom + 1 nastavak za bočicu.
English: Table 1 Adverse reactions by preferred term for pasireotide intramuscular use
Croatian: Tablica 1 Nuspojave za pasireotid koji se primjenjuje intramuskularno prema preporučenom izrazu
English: Pasireotide is eliminated mainly via hepatic clearance (biliary excretion), with a small contribution of the renal route.
Croatian: Pasireotid se eliminira putem hepatičkog klirensa (izlučivanje u žuči), pri čemu se mali dio izlučuje putem bubrega.
English: Table 1 Adverse reactions in the phase III study in Cushing's disease patients
Croatian: Tablica 1 Nuspojave u ispitivanju faze III na bolesnicima s Cushingovom bolešću
English: Signifor is to be administered by deep intramuscular injection by a trained healthcare professional.
Croatian: Signifor mora primjenjivati educirani zdravstveni radnik dubokom intramuskularnom injekcijom.
English: Cholelithiasis is a recognised adverse reaction associated with somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Croatian: Kolelitijaza je poznata nuspojava povezana s analozima somatostatina i često se prijavljuje u kliničkim ispitivanjima s pasireotidom (vidjeti dio 4.8).
English: Diarrhoea, nausea, abdominal pain*
Croatian: Proljev, mučnina, bol u abdomenu*
English: Signifor is intended for subcutaneous use.
Croatian: Signifor je namijenjen za potkožnu primjenu.
English: The recommended starting dose of Signifor in acromegaly is 40 mg every 4 weeks.
Croatian: Preporučena početna doza Signifora kod akromegalije je 40 mg svaka 4 tjedna.
English: 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.
Croatian: 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.
English: The usual starting dose of Signifor in Cushing's disease is 10 mg every 4 weeks.
Croatian: Uobičajena početna doza Signifora kod Cushingove bolesti je 10 mg svaka 4 tjedna.
English: Hyperglycaemia, diabetes mellitus
Croatian: Hiperglikemija, šećerna bolest
English: 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]).
Croatian: 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]).
English: Signifor intramuscular use 60 mg
Croatian: Signifor primijenjen intramuskularno 60 mg
English: Signifor intramuscular use 40 mg
Croatian: Signifor primijenjen intramuskularno 40 mg
English: Solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Croatian: Otapalo: karmelozanatrij, manitol, poloksamer 188, voda za injekcije.
English: GH<2.5 μg/l and normalised IGF-1*
Croatian: GH<2,5 μg/l i normalizirani IGF-1*
English: Very common (may affect more than 1 in 10 people) - Diarrhoea - Nausea - Abdominal pain - Fatigue
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - Proljev - Mučnina - Bol u abdomenu - Umor
English: 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″)
Croatian: 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
English: Solvent for Signifor
Croatian: Otapalo za Signifor
English: Liver tests
Croatian: Testovi funkcije jetre
English: 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.
Croatian: 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.
English: 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]).
Croatian: 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]).
English: Step 1:
Croatian: Korak 1:
English: Step 8:
Croatian: Korak 8:
English: Powder: poly(D,L-lactide-co-glycolide) (50-60:40-50), poly(D,L-lactide-co-glycolide) (50:50).
Croatian: Prašak: poli(D,L-laktid-ko-glikolid) (50-60:40-50), poli(D,L-laktid-ko-glikolid) (50:50).
English: 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.
Croatian: 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.
English: Female patients of childbearing potential should be advised to use adequate contraception if necessary during treatment with Signifor (see section 4.6).
Croatian: Bolesnice reproduktivne dobi potrebno je upozoriti da tijekom liječenja Signiforom, ako je potrebno, koriste djelotvornu kontracepciju (vidjeti dio 4.6).
English: Glucose metabolism disorders
Croatian: Poremećaji metabolizma glukoze
English: Screw the safety injection needle onto the syringe.
Croatian: Zavrtanjem pričvrstite iglu za injekciju sa zaštitnim mehanizmom na štrcaljku.
English: Month 12 * Includes one patient with significant outlying results who had a percent change from baseline of
Croatian: * Uključuje jednog bolesnika sa značajnim izraženim rezultatima koji je imao postotak promjene od početne vrijednosti od +542,2%.
English: Poly(D,L-lactide-co-glycolide) (50-60:40-50) Poly(D,L-lactide-co-glycolide) (50:50)
Croatian: Poli(D,L-laktid-ko-glikolid) (50-60:40-50) Poli(D,L-laktid-ko-glikolid) (50:50)
English: 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,
Croatian: 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:
English: - In the solvent: carmellose sodium, mannitol, poloxamer 188, water for injections.
Croatian: U otapalu: karmelozanatrij, manitol, poloksamer 188, voda za injekcije.
English: 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″)
Croatian: 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
English: One-point-cut colourless, type I glass ampoule containing 1 ml of solution.
Croatian: Bezbojna staklena ampula (staklo tipa I) sa zarezom na mjestu loma koja sadrži 1 ml otopine.
English: Studies in rats in which pasireotide was administered via the subcutaneous route have shown effects on female reproductive parameters (see section 5.3).
Croatian: Ispitivanja na štakorima u kojih se pasireotid primjenjivao supkutano pokazala su učinke na ženske reproduktivne parametre (vidjeti dio 5.3).
English: 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.
Croatian: U zdravih dobrovoljaca pasireotid se brzo apsorbira, a vršna koncentracija u plazmi postiže se u roku od 0,25-0,5 h.
English: Powder and solvent for suspension for injection
Croatian: Prašak i otapalo za suspenziju za injekciju
English: For information on the instructions for use, please see the end of the package leaflet “How to inject Signifor”.
Croatian: Za informacije o uputama za uporabu, molimo vidjeti kraj upute o lijeku
English: Diarrhoea, abdominal pain, nausea
Croatian: Proljev, bol u abdomenu, mučnina
English: The influence of the P-gp inhibitor verapamil on the pharmacokinetics of subcutaneous pasireotide was tested in a drug-drug interaction study in healthy volunteers.
Croatian: U ispitivanju interakcija među lijekovima u zdravih dobrovoljaca ispitivan je utjecaj P-gp inhibitora verapamila na farmakokinetiku supkutano primijenjenog pasireotida.
English: PRE-FILLED SYRINGE LABEL
Croatian: NALJEPNICA ZA NAPUNJENU ŠTRCALJKU
English: No clinical studies in subjects with liver impairment have been performed with pasireotide intramuscular use.
Croatian: Nisu provedena klinička ispitivanja s pasireotidom primijenjenim intramuskularno u ispitanika s oštećenjem jetre.
English: GH<2.5 μg/l * Primary endpoint (patients with IGF-1< lower limit of normal (LLN) were not considered “responders”).
Croatian: * Mjera primarnog ishoda (bolesnici s IGF-1 ispod donje granice normale (DGN) nisu se smatrali bolesnicima s odgovorom).
English: INSTRUCTIONS FOR USE OF SIGNIFOR POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Croatian: UPUTE ZA PRIMJENU SIGNIFOR PRAŠKA I OTAPALA ZA SUSPENZIJU ZA INJEKCIJU
English: What Signifor looks like and contents of the pack Signifor solution for injection is a clear, colourless solution in an ampoule.
Croatian: Signifor otopina za injekciju je bistra, bezbojna otopina u ampuli.
English: Studies in animals in which pasireotide was administered via the subcutaneous route have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama u kojima se pasireotid primjenjivao supkutano pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: In acromegaly patients, gastrointestinal disorders were less frequent in inadequately controlled patients compared to medically naïve patients.
Croatian: 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.
English: Glycosylated haemoglobin increased
Croatian: Povišenje glikiranog hemoglobina
English: How to use Signifor
Croatian: Kako primjenjivati Signifor
English: In Cushing's disease patients, elevated FPG levels was the most frequently reported CTC Grade 3 laboratory abnormality (14.7% of patients) in the phase III study G2304; with no cases of Grade 4 reported.
Croatian: 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.
English: 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.
Croatian: 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.
English: Tartaric acid Sodium hydroxide Water for injections
Croatian: 6.1 Popis pomoćnih tvari manitol tartaratna kiselina natrijev hidroksid voda za injekcije
English: You may experience yellowing of the skin, dark urine,
Croatian: Možete primijetiti žutilo kože, tamnu mokraću, blijede stolice i svrbež.
English: - Gallstones.
Croatian: - Žučni kamenci.
English: Adverse reactions of hyperglycaemia and diabetes mellitus led to study discontinuation in 3 (2.0%) and 4 patients (2.7%), respectively.
Croatian: Hiperglikemija kao nuspojava dovela je do prekida ispitivanja u 3 (2,0%) bolesnika, a šećerna bolest u 4 (2,7%) bolesnika.
English: Signifor 0.3 mg solution for injection Signifor 0.6 mg solution for injection Signifor 0.9 mg solution for injection
Croatian: Signifor 0,3 mg otopina za injekciju Signifor 0,6 mg otopina za injekciju Signifor 0,9 mg otopina za injekciju
English: 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.
Croatian: 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.