natgillin/translations-raw huggingface dataset:
In study C2402, grade 3 elevated fasting glucose levels were reported in 14.3% and 17.7% of acromegaly patients treated with pasireotide intramuscular use 40 mg and 60 mg respectively, and in no patients in the active control group.
U ispitivanju C2402, povišene razine glukoze natašte stupnja 3 bile su prijavljene u 14,3% odnosno 17,7% bolesnika s akromegalijom liječenih s 40 mg odnosno 60 mg pasireotida primijenjenog intramuskularno te ni u jednog bolesnika u skupini s aktivnom kontrolom.
The most common adverse reactions (incidence ≥1/10) in the phase III study G2304 were hyperglycaemia, diarrhoea, cholelithiasis and diabetes mellitus.
Najčešće nuspojave (incidencija ≥1/10) u ispitivanju G2304 faze III bile su hiperglikemija, proljev, kolelitijaza i šećerna bolest.
Rare cases of concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN have been observed.
Bili su opaženi rijetki slučajevi istodobnih povišenja ALT-a većih od 3 x GGN i bilirubina većih od 2 x GGN.
The responder rate at month 12 was comparable to month 6, with 13.4% and 25.0% in the 0.6 mg and 0.9 mg twice-daily groups, respectively.
Stopa odgovora u 12. mjesecu bila je usporediva s onom u 6. mjesecu, s 13,4% odnosno 25,0% u skupini koja je primala 0,6 mg odnosno 0,9 mg dvaput na dan.
Injection site reaction includes injection site pain, injection site nodule, injection site discomfort, injection site bruising, injection site pruritus, injection site reaction, injection site hypersensitivity and injection site swelling.
Reakcija na mjestu primjene injekcije uključuje bol na mjestu primjene, kvržicu na mjestu primjene, nelagodu na mjestu primjene, stvaranje modrica na mjestu primjene, pruritus na mjestu primjene, reakciju na mjestu primjene, preosjetljivost na mjestu primjene i oticanje na mjestu primjene injekcije.
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.
Djelotvornost pasireotida primijenjenog intramuskularno dokazana je u dva multicentrična ispitivanja faze III u bolesnika s akromegalijom te u jednom multicentričnom ispitivanju faze III u bolesnika s Cushingovom bolešću.
Age has been found to be a covariate in the population pharmacokinetic analysis of Cushing's disease patients.
Pokazalo se da je dob kovarijabla u farmakokinetičkoj analizi populacije bolesnika s Cushingovom bolešću.
A phase III, multicentre, randomised study was conducted to evaluate the safety and efficacy of different dose levels of Signifor over a twelve-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Multicentrično, randomizirano ispitivanje faze III bilo je provedeno da bi se procijenila sigurnost i djelotvornost različitih doza Signifora tijekom razdoblja liječenja od 12 mjeseci kod bolesnika s perzistentnom ili rekurentnom Cushingovom bolešću, ili kod de novo bolesnika u kojih kirurški zahvat nije bio indiciran ili koji su odbili kirurški zahvat.
Each unit pack contains the vial and pre-filled syringe in a sealed blister tray with one vial adapter and one safety-engineered needle for injection.
Svako jedinično pakiranje sadrži bočicu i napunjenu štrcaljku u zatvorenom podlošku s jednim nastavkom za bočicu i jednom iglom za injekciju sa zaštitnim mehanizmom.
Acromegaly The recommended initial dose for the treatment of acromegaly is 40 mg of pasireotide every 4 weeks.
Akromegalija Preporučena početna doza za liječenje akromegalije je 40 mg pasireotida svaka 4 tjedna.
Patients were randomised in a 1:1 ratio to a starting dose of either 10 mg or 30 mg pasireotide intramuscular use every 4 weeks.
Bolesnici su bili randomizirani u omjeru 1:1 na primanje početne doze od 10 mg ili 30 mg pasireotida primijenjenog intramuskularno svaka 4 tjedna.
- Problems with bile flow (cholestasis).
- Problemi s protokom žuči (kolestaza).
Acromegaly study C2402, inadequately controlled patients Study C2402 was a phase III, multicentre, randomised, parallel-group, three-arm study of double-blind pasireotide intramuscular use 40 mg and 60 mg versus open-label octreotide intramuscular use 30 mg or lanreotide deep subcutaneous injection 120 mg in patients with inadequately controlled acromegaly.
Ispitivanje u bolesnika s akromegalijom C2402, neodgovarajuće kontrolirani bolesnici Ispitivanje C2402 bilo je multicentrično, randomizirano ispitivanje faze III s tri paralelne skupine u kojem se ispitivao dvostruko slijepi pasireotid 40 mg i 60 mg primijenjen intramuskularno u usporedbi s otvorenim ispitivanjem u kojem se primjenjivao oktreotid 30 mg intramuskularno ili lanreotid 120 mg dubokom supkutanom injekcijom u bolesnika s neodgovarajuće kontroliranom akromegalijom.
Self monitoring of blood glucose and/or FPG assessments should be done weekly for the first two to three months and periodically thereafter, as clinically appropriate, as well as over the first two to four weeks after any dose increase.
Bolesnici trebaju sami pratiti glukozu u krvi i/ili obavljati pretrage FPG-a tjedno tijekom prva dva ili tri mjeseca te periodički nakon toga, kako je klinički potrebno, kao i tijekom prva dva do četiri tjedna nakon svakog povećanja doze.
As the pharmacological activity of pasireotide mimics that of somatostatin, inhibition of pituitary hormones other than ACTH cannot be ruled out.
Budući da farmakološka aktivnost pasireotida oponaša aktivnost somatostatina, ne može se isključiti inhibicija i drugih hormona hipofize pored ACTH-a.
Coagulation abnormalities
Abnormalnosti u koagulaciji
<2.5 µg/l and normalisation of IGF-1 at the same time point was also comparable between the two treatment arms.
Postotak bolesnika koji su imali srednje vrijednosti GH-a <2,5 µg/l i normalizaciju IGF-1 u istoj vremenskoj točki također je bio usporediv između dviju terapijskih skupina.
The European Medicines Agency has waived the obligation to submit the results of studies with Signifor in all subsets of the paediatric population 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 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).
Cholecystitis *, cholestasis
Kolecistitis*, kolestaza
The proportion of patients with a reduction or no change in pituitary tumour volume at week 24 was 81.0% and 70.3% on pasireotide intramuscular use 40 and 60 mg, and 50.0% on active control.
Udio bolesnika sa smanjenjem ili bez promjene volumena tumora hipofize u 24. tjednu bio je 81,0% odnosno 70,3% uz pasireotid 40 odnosno 60 mg primijenjen intramuskularno, te 50,0% uz aktivnu kontrolu.
Cholelithiasis is a recognised adverse reaction associated with long-term use of somatostatin analogues and has frequently been reported in clinical studies with pasireotide (see section 4.8).
Kolelitijaza je poznata nuspojava povezana s dugoročnom uporabom analoga somatostatina i često se prijavljuje u kliničkim ispitivanjima s pasireotidom (vidjeti dio 4.8).
The efficacy and safety of pasireotide intramuscular use was evaluated in a phase III, multicentre study over a 12-month treatment period in Cushing's disease patients with persistent or recurrent disease or de novo patients for whom surgery was not indicated or who refused surgery.
Djelotvornost i sigurnost pasireotida primijenjenog intramuskularno ocjenjivala se u multicentričnom ispitivanju faze III tijekom 12-mjesečnog razdoblja liječenja u bolesnika s Cushingovom bolešću koji su imali perzistentnu ili rekurentnu bolest ili u de novo bolesnika za koje kirurški zahvat nije bio indiciran ili koji su ga odbili.
Signifor should be administered using sterile disposable syringes and injection needles.
Signifor treba primjenjivati koristeći sterilne štrcaljke i igle za injekcije za jednokratnu uporabu.
In a clinical study of a single subcutaneous dose of pasireotide in subjects with impaired hepatic function, statistically significant differences were found in subjects with moderate and severe hepatic impairment (Child-Pugh B and C).
U kliničkom ispitivanju s jednokratnom supkutanom dozom pasireotida u ispitanika s oštećenom funkcijom jetre pronađene su statistički značajne razlike u ispitanika s umjerenim i teškim oštećenjem jetre (Child-Pugh B i C).
Secondary end-points included, among others, changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease.
Sekundarne mjere ishoda uključivale su, između ostaloga, promjene od početne vrijednosti u: 24-satnom UFC-u, ACTH-u u plazmi, razinama kortizola u serumu, te kliničkim znakovima i simptomima Cushingove bolesti.
Cushings disease: the recommended initial dose for Cushing's disease patients with moderate hepatic impairment (Child Pugh B) is 10 mg every 4 weeks, and the maximum recommended dose for these patients is 20 mg every 4 weeks (see section 5.2).
Cushingova bolest: preporučena početna doza za bolesnike s Cushingovom bolešću i s umjerenim oštećenjem jetre (Child Pugh B) iznosi 10 mg svaka 4 tjedna, a najveća preporučena doza za te bolesnike je 20 mg svaka 4 tjedna (vidjeti dio 5.2).
Secondary end points included changes from baseline in: 24-hour UFC, plasma ACTH, serum cortisol levels, and clinical signs and symptoms of Cushing's disease.
Mjere sekundarnog ishoda uključivale su promjene u odnosu na početnu vrijednost: 24-satnog UFC-a, ACTH-a u plazmi, razina kortizola u serumu i kliničkih znakova i simptoma Cushingove bolesti.
The solvent is a clear, colourless to slightly yellow or slightly brown solution in a pre-filled syringe.
Otapalo je bistra, bezbojna do blago žuta ili blago smeđa otopina u napunjenoj štrcaljki.
Acromegaly: the recommended initial dose for acromegaly patients with moderate hepatic impairment (Child Pugh B) is 20 mg every 4 weeks, and the maximum recommended dose for these patients is 40 mg every 4 weeks (see section 5.2).
Akromegalija: preporučena početna doza za bolesnike s akromegalijom i s umjerenim oštećenjem jetre (Child Pugh B) iznosi 20 mg svaka 4 tjedna (vidjeti dio 5.2), a najveća preporučena doza za te bolesnike je 40 mg svaka 4 tjedna (vidjeti dio 5.2).
Improvements were observed in both dose groups for CushingQoL and the Mental Component Summary (MCS) of SF-12v2, but not for the Physical Component Summary (PCS) of SF-12v2.
Mental Component Summary), ali ne i prema PCS u SF-12v2 (eng.
Acromegaly
Akromegalija
Dose reduction by decrements of 0.3 mg twice a day is suggested.
Preporučuje se smanjenje doze za po 0,3 mg dvaput na dan.
Most patients (83.3%) had persistent or recurrent Cushing's disease and few (≤5%) in either treatment group had received previous pituitary irradiation.
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.
Monitoring of blood glucose levels in patients treated with Signifor is recommended (see section 4.4).
Kod bolesnika liječenih Signiforom preporučuje se praćenje razina glukoze u krvi (vidjeti dio 4.4).
(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
(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
The recommended initial dose for the treatment of Cushing's disease is 10 mg of pasireotide by deep intramuscular injection every 4 weeks.
Preporučena početna doza za liječenje Cushingove bolesti je 10 mg pasireotida dubokom intramuskularnom injekcijom svaka 4 tjedna.
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).
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).
Signifor is to be administered subcutaneously by self injection.
Signifor se primjenjuje supkutano samoubrizgavanjem.
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