FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with known congenital or acquired long QT syndrome and in patients with a history of torsades de pointes, the use of macimorelin may only be considered in a cardiovascular clinical unit.
Croatian: U bolesnika s poznatim kongenitalnim ili stečenim sindromom dugog QT intervala te u bolesnika s torsades de pointes u anamnezi, primjena macimorelina može se uzeti u obzir samo u kliničkoj jedinici kardiovaskularne skrbi.
English: These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5).
Croatian: Te tvari mogu dovesti do nepouzdanih rezultata za stimulaciju hormona rasta (vidjeti također dijelove 4.4 i 4.5).
English: For both GHSTs, the estimated specificity was 0.96, irrespective of the in/exclusion data from not matched Group A subjects.
Croatian: U oba testa stimulacije hormona rasta, procijenjena specifičnost bila je 0,96 bez obzira na uključivanje/isključivanje nepodudarnih ispitanika iz skupine A.
English: Strong CYP3A4 inducers should be discontinued and a washout time of five elimination half-lives should be considered prior to test administration.
Croatian: Primjenu snažnih induktora enzima CYP3A4 treba prekinuti i prije primjene testa razmotriti vrijeme ispiranja lijeka od pet poluvjekova eliminacije.
English: Exogenous GH or medicinal products directly affecting the pituitary gland could influence the somatotropic function of the pituitary gland and lead to unreliable GH stimulation results (see also section 4.2 and section 4.5).
Croatian: Egzogeni hormon rasta ili lijekovi koji izravno utječu na hipofizu mogu utjecati na somatotropnu funkciju hipofize i dovesti do nepouzdanih rezultata stimulacije hormona rasta (vidjeti također dio 4.2 i dio 4.5).
English: • medicines to treat infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
Croatian: • lijekovi za liječenje infekcija (antibiotici kao što je eritromicin, klaritromicin, moksifloksacin)
English: If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded.
Croatian: Ako se macimorelin primijeni u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije, ne može se isključiti mogućnost povišene koncentracije macimorelina u plazmi.
English: The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively.
Croatian: Procjene negativnog i pozitivnog slaganja iznosile su 95 % odnosno 86 %, s donjom granicom 95 %-tnog intervala pouzdanosti od 87 % odnosno 75 %.
English: Fluid intake of no more than 100 mL of non-carbonated water is allowed each within 1 hour pre-dose, as well as within 1 hour post-dose (see section 4.4).
Croatian: Unos tekućine dopušten je u obliku negazirane vode, i to ne više od 100 ml unutar 1 sata prije primjene doze te ne više od 100 ml unutar 1 sata poslije primjene doze (vidjeti dio 4.4).
English: Negative and positive agreement between MAC and the ITT in subjects with intermediate or low risk (Groups B and C) were 93% and 61% with lower 95% confidence interval bounds 80% and 43%, respectively.
Croatian: Negativno i pozitivno slaganje između MAC i ITT testa u ispitanika s umjerenim ili malim rizikom (skupine B i C) iznosilo je 93 % odnosno 61 %, s donjom granicom 95 %-tnog intervala pouzdanosti od 80 % odnosno 43 %.
English: • you have heart disease or problems with your heart rhythm (including congenital or acquired long QT syndrome or a history of so called torsades de pointes tachycardias).
Croatian: • ako imate srčanu bolest ili tegobe sa srčanim ritmom (uključujući urođeni ili stečeni sindrom produljenog QT intervala ili ste u prošlosti imali tahikardije, tzv. torsades de pointes).
English: Macimorelin Aeterna Zentaris has minor influence on the ability to drive and use machines.
Croatian: Macimorelin Aeterna Zentaris malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: You must not be given Macimorelin Aeterna Zentaris • if you are allergic to macimorelin or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na macimorelin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Sensitivity and specificity for both growth hormone stimulation tests (GHSTs) were estimated, assuming all high likelihood AGHD subjects of Group A as ‘true' AGHD subjects and all healthy matching subjects of Group D as ‘true' AGHD negative subjects.
Croatian: Za oba testa stimulacije hormona rasta procijenjene su osjetljivost i specifičnost, uz pretpostavku da su svi ispitanici s velikom vjerojatnošću nedostatka hormona rasta iz skupine A „stvarni” ispitanici s nedostatkom, a svi zdravi podudarni ispitanici iz skupine D „stvarno” negativni ispitanici s obzirom na nedostatak hormona rasta.
English: Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin.
Croatian: Maksimalne razine hormona rasta opažene su približno 45 do 60 minuta nakon primjene macimorelina.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po vrećici, tj. zanemarive količine natrija.
English: The suspension should be stirred again, when some particles settle at the bottom of the container for example after the suspension is left standing for some time.
Croatian: Ako se na dno slegne nešto čestica, kao na primjer kada se suspenziju ostavi stajati neko vrijeme, suspenziju je potrebno ponovno promiješati.
English: The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2.
Croatian: Sigurnost primjene i dijagnostička uspješnost macimorelina u bolesnika s indeksom tjelesne mase ITM > 40 kg/m2 nisu utvrđene.
English: The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years.
Croatian: Farmakodinamika macimorelina nije zadovoljavajuće procijenjena u starije populacije u dobi
English: If you are given more Macimorelin Aeterna Zentaris than you should
Croatian: Ako ste primili više lijeka Macimorelin Aeterna Zentaris nego što ste trebali
English: QTc prolongation
Croatian: Produljenje QTc intervala
English: A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively.
Croatian: Tekući obrok smanjio je Cmax macimorelina 0,42 puta te AUC 0,5 puta.
English: The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
Croatian: Cjelokupni sadržaj jedne vrećice rastopi se u 120 ml, dok se dvije vrećice rastope u 240 ml, prema potrebi.
English: A similar increase in the QTcF interval was also observed in a single-ascending dose study, which included three dose levels (0.5 mg/kg, 1 mg/kg and 2 mg/kg (2 times and 4 times the recommended dosage, respectively)).
Croatian: QTcF intervala opaženo je i u ispitivanju povećanja jednostruke doze, koje je uključivalo tri razine doze (0,5 mg/kg, 1 mg/kg i 2 mg/kg (2 puta odnosno 4 puta veće od preporučene doze)).
English: Each sachet contains 1,817 mg granules.
Croatian: Jedna vrećica sadrži 1817 mg granula.
English: Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin
Croatian: Prekid terapije hormonom rasta ili lijekom koji izravno utječe na lučenje somatotropina iz hipofize
English: A dose of 0.5 mg/kg macimorelin was shown to induce maximal GH release.
Croatian: Pokazalo se da doza od 0,5 mg/kg macimorelina izaziva maksimalno otpuštanje hormona rasta.
English: Residual suspension must be discarded according to local regulations.
Croatian: Ostatak suspenzije mora se baciti sukladno nacionalnim propisima.
English: Co-administration of a CYP3A4 inhibitor may increase the macimorelin plasma concentration, and this, in turn, could yield higher plasma GH levels.
Croatian: Istodobna primjena inhibitora enzima CYP3A4 može povećati koncentraciju macimorelina u plazmi, a to bi zauzvrat moglo proizvesti veće koncentracije hormona rasta u plazmi.
English: The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study that investigated in a 3-way cross-over design with 60 healthy subjects the effects of a supra-therapeutic dose of macimorelin (2 mg/kg, i.e., 4 times the recommended dosage) in comparison with placebo and with moxifloxacin.
Croatian: Učinci macimorelina na parametre EKG-a ispitivani su u posebnom temeljitom ispitivanju QT intervala trostruko ukriženog ustroja, u kojem su u 60 zdravih ispitanika ispitivani učinci supraterapijske doze macimorelina (2 mg/kg, tj. doza 4 puta veća od preporučene) u usporedbi s placebom i moksifloksacinom.
English: Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
Croatian: A saharinnatrij dihidrat natrijev stearilfumarat
English: The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Croatian: Granična vrijednost macimorelina u prijelaznom razdoblju od kasnog puberteta do pune zrelosti odrasle dobi nije utvrđena.
English: • Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
Croatian: • s lijekovima koji privremeno mogu povisiti koncentracije hormona rasta (kao što su klonidin, levodopa i inzulin)
English: Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.
Croatian: Macimorelin stimulira otpuštanje hormona rasta aktivacijom sekretagognih receptora hormona rasta prisutnih u hipofizi i hipotalamusu.
English: • Medicinal products that may blunt the growth hormone response to macimorelin (such as muscarinic antagonists: atropine, anti-thyroid medicinal products: propylthiouracil and growth hormone medicinal products).
Croatian: • s lijekovima koji mogu oslabiti odgovor hormona rasta na macimorelin (kao što su muskarinski antagonisti: atropin, antitiroidni lijekovi: propiltiouracil i lijekovi za hormon rasta).
English: Co-administration of macimorelin with medicinal products with a potential to induce torsades de pointes (antipsychotic medicinal products e.g. chlorpromazine, haloperidol, antibiotics (e.g., moxifloxacin, erythromycin, clarithromycin), anti-arrhythmics Class Ia (e.g. quinidine), and Class III (e.g. amiodarone, procainamide, sotalol) or any other medicinal products that may induce torsades de pointes) should be avoided (see section 4.4).
Croatian: Potrebno je izbjegavati istodobnu primjenu macimorelina i lijekova koji mogu izazvati torsades de pointes (antipsihotici, npr. klorpromazin, haloperidol, antibiotici (npr. moksifloksacin, eritromicin, klaritromicin), antiaritmici skupine Ia (npr. kinidin) i skupine III (npr. amiodaron, prokainamid, sotalol) ili bilo kojih drugih lijekova koji mogu izazvati torsades de pointes) (vidjeti dio 4.4).
English: D-60314 Frankfurt am Main, Germany
Croatian: D-60314 Frankfurt am Main, Njemačka
English: Adverse reactions reported in Study 052 are listed below by MedDRA body system organ class and by frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: An in vitro human liver microsomes study showed that CYP3A4 is the major enzyme to metabolize macimorelin.
Croatian: Ispitivanje na ljudskim jetrenim mikrosomima in vitro pokazalo je da je CYP3A4 glavni enzim kojim se metabolizira macimorelin.
English: For both the ITT and the MAC test, serum concentrations of GH were measured at 30, 45, 60 and 90 minutes after administration.
Croatian: U oba testa, ITT i MAC testu, koncentracije hormona rasta u serumu izmjerene su 30, 45, 60 i 90 minuta nakon primjene.
English: 1 mL of the reconstituted suspension contains 500 micrograms macimorelin.
Croatian: Jedan (1) ml rekonstituirane suspenzije sadrži 500 mikrograma macimorelina.
English: What Macimorelin Aeterna Zentaris is and what it is used for 2.
Croatian: Što je Macimorelin Aeterna Zentaris i za što se koristi 2.
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1).
Croatian: Macimorelin uzrokuje produljenje korigiranog QT intervala (QTc) za oko 11 ms (vidjeti dio 5.1).
English: • Drinking - up to 100 mL of still water is allowed each within 1 hour before as well as within 1 hour after macimorelin intake.
Croatian: • unos tekućine - dopušteno je do 100 ml obične vode unutar 1 sata prije te 1 sata poslije unosa macimorelina.
English: • lower than normal heart rate (sinus bradycardia)
Croatian: • osjećaj lupanja srca • sporiji srčani otkucaji nego što je normalno (sinusna bradikardija)
English: The estimates for negative and positive agreement between MAC and the ITT in the overall study population were 94% and 74% with lower 95% confidence interval bounds 85% and 63%, respectively.
Croatian: Procjene negativnog i pozitivnog slaganja rezultata MAC i ITT testova u ukupnoj ispitivanoj populaciji bile su 94 % odnosno 74 %, s donjom granicom 95 %-tnog intervala pouzdanosti od 85 %
English: The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight.
Croatian: Preporučena doza lijeka Macimorelin Aeterna Zentaris iznosi 0,5 mg po kg tjelesne težine.
English: The concomitant use with medicinal products that are known to induce torsades de pointes should be avoided (see also section 4.5).
Croatian: Potrebno je izbjegavati istodobnu primjenu lijekova za koje se zna da izazivaju torsades de pointes (vidjeti također dio 4.5).
English: The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study of a supra-therapeutic dose of macimorelin (2 mg/kg) and in a single-ascending dose study, which included three dose levels of macimorelin (0.5 mg/kg, 1 mg/kg and 2 mg/kg).
Croatian: Učinci macimorelina na parametre EKG-a ispitivani su u posebnom temeljitom ispitivanju QT intervala kod supraterapijske doze macimorelina (2 mg/kg) te u ispitivanju povećanja jednostruke doze, koje je uključilo tri razine doze macimorelina (0,5 mg/kg, 1 mg/kg i 2 mg/kg).
English: The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2).
Croatian: Oštećenje bubrežne i/ili jetrene funkcije Sigurnost i djelotvornost macimorelina u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije nisu ustanovljene (vidjeti također dio 5.2).
English: 38 (27%) in Group A, 37 (26%) in Group B, 40 (29%) in Group C and 25 (18%) in Group D. One out of 154 MAC tests (0.6%) performed failed due to a technical error and 27 out of 157 ITTs (17.2%) performed failed because induction of severe hypoglycemia (i.e., the stimulus) could not be achieved.
Croatian: Jedan od 154 provedena MAC testa (0,6 %) nije uspio zbog tehničke greške, a 27 od 157 provedenih ITT testova (17,2 %) nije uspjelo jer nije bilo moguće inducirati tešku hipoglikemiju (tj. stimulus).
English: In dose finding studies in healthy subjects, maximum stimulation of GH secretion was achieved following single dose administration of 0.5 mg/kg macimorelin.
Croatian: U ispitivanjima određivanja doze provedenim u zdravih ispitanika maksimalna stimulacija lučenja hormona rasta postignuta je nakon primjene jednokratne doze macimorelina od 0,5 mg/kg.
English: Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours.
Croatian: Srednja vrijednost terminalnog poluvijeka eliminacije (T1/2) macimorelina iznosi 4,1 sat.
English: Macimorelin is metabolised mainly by CYP3A4 in vitro.
Croatian: Macimorelin se in vitro metabolizira uglavnom pomoću enzima CYP3A4.
English: GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK).
Croatian: Razine hormona rasta određivane su centralno pomoću testa IDS-iSYS (Immunodiagnostic Systems
English: Preclinical data from safety pharmacology, repeated dose toxicity and genotoxicity studies reveal no specific hazard for humans.
Croatian: Neklinički podatci ne upućuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aeterna Zentaris GmbH
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Aeterna Zentaris GmbH
English: Determine the number of Macimorelin Aeterna Zentaris sachets needed based on body weight: one sachet will be required for a patient weighing up to 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Croatian: Odredite broj vrećica lijeka Macimorelin Aeterna Zentaris potrebnih na temelju tjelesne težine: jedna vrećica potrebna je za bolesnika težine do 120 kg, dvije vrećice potrebne su ako bolesnik teži više od
English: • that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
Croatian: • koji bi mogli smanjiti odgovor hormona rasta na macimorelin, kao što su atropin, propiltiouracil, lijekovi za hormon rasta
English: The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
Croatian: Preporučena pojedinačna doza rekonstituirane suspenzije sadrži 500 mikrograma macimorelina po kg tjelesne težine.
English: Each sachet contains 60 mg macimorelin (as acetate).
Croatian: Jedna vrećica sadrži 60 mg macimorelina (u obliku acetata).
English: Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin.
Croatian: Bolesnicima na nadomjesnoj terapiji hormonom rasta (somatotropin) ili na terapiji lijekom koji izravno utječe na lučenje somatotropina u hipofizi (npr. analozi somatostatina, klonidin, levodopa i agonisti dopamina) treba savjetovati da prekinu to liječenje najmanje 1 mjesec prije nego što prime testnu dozu macimorelina.
English: Contains lactose monohydrate 1,691.8 mg per sachet.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Sadrži 1691,8 mg laktoze hidrata po vrećici.
English: CYP3A4 is the major enzyme to metabolize macimorelin.
Croatian: Biotransformacija CYP3A4 glavni je enzim kojim se metabolizira macimorelin.
English: D-60314 Frankfurt am Main Germany
Croatian: D-60314 Frankfurt am Main
English: Marketing Authorisation Holder and Manufacturer Aeterna Zentaris GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Aeterna Zentaris GmbH
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1).
Croatian: Nekim nepoznatim mehanizmom macimorelin uzrokuje produljenje korigiranog QT (QTc) intervala za oko 11 ms (vidjeti također dio 5.1).
English: Repeat testing may be warranted in this situation.
Croatian: U toj situaciji može biti potrebno ponoviti testiranje.
English: Medicinal products with a potential to induce torsades de pointes
Croatian: Lijekovi koji mogu izazvati torsades de pointes
English: What you need to know before Macimorelin Aeterna Zentaris is given 3.
Croatian: Što morate znati prije nego primite Macimorelin Aeterna Zentaris 3.
English: • a bitter or metallic taste (dysgeusia)
Croatian: • gorak/metalni okus (poremećen osjet okusa)
English: • that could increase growth hormone levels: such as clonidine, levodopa, insulin
Croatian: • koji bi mogli povisiti razine hormona rasta, kao što su klonidin, levodopa, inzulin
English: Patients with a deficiency affecting hormones other than GH (e.g. adrenal, thyroidal and/or gonadal insufficiency, diabetes insipidus) should be adequately replaced with the other deficient hormones before any testing for a deficiency of GH stimulation is performed, to exclude a stimulation failure due to a secondary GH deficiency.
Croatian: Bolesnici s nedostatkom drugih hormona osim hormona rasta Bolesnicima s nedostatkom drugih hormona osim hormona rasta (npr. insuficijencija nadbubrežne žlijezde, štitnjače i/ili spolnih žlijezda, insipidni dijabetes) treba na odgovarajući način nadomjestiti nedostatak drugih hormona prije testiranja na nedostatak stimulacije hormona rasta kako bi se isključila neuspješna stimulacija zbog sekundarnog nedostatka hormona rasta.
English: • The other ingredients are: lactose monohydrate (see section 2 under ‘Macimorelin Aeterna Zentaris contains lactose'), colloidal anhydrous silica,
Croatian: • Drugi sastojci su: laktoza hidrat (pogledajte dio 2. pod naslovom „Macimorelin Aeterna Zentaris sadrži laktozu”), koloidni bezvodni silicijev dioksid, krospovidon tipa A, saharinnatrij dihidrat i natrijev stearilfumarat (pogledajte dio 2. pod naslovom „Macimorelin Aeterna Zentaris sadrži natrij”).
English: The diagnostic efficacy of Macimorelin Aeterna Zentaris was established in a randomized, open-label, single dose, cross-over study (AEZS-130-052) comparing the level of agreement between the macimorelin test (MAC) results and insulin tolerance test (ITT) results.
Croatian: otvorenom, ukriženom ispitivanju jedne doze (AEZS-130-052) u kojem se uspoređivala razina slaganja rezultata dobivenih macimorelinskim testom (MAC) i onih dobivenih testom podnošljivosti inzulina (ITT).
English: MedDRA organ class
Croatian: MedDRA klasifikacija organskih sustava
English: Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin.
Croatian: Mehanizam djelovanja Macimorelin je oralno raspoloživ peptidomimetik sa sekretagognom aktivnošću za hormon rasta sličnom grelinu.
English: If any of the above applies to you, or if you are not sure, talk to your doctor or nurse before you are given this medicine.
Croatian: Ako se išta od prethodno navedenog odnosi na Vas ili ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite lijek.
English: Concomitant use of strong CYP3A4 inducers with Macimorelin Aeterna Zentaris can decrease macimorelin plasma levels significantly and thereby lead to a false positive result (see also section 4.5).
Croatian: Istodobna primjena snažnih induktora enzima CYP3A4 i lijeka Macimorelin Aeterna Zentaris može značajno sniziti koncentracije macimorelina u plazmi i tako dovesti do lažno pozitivnih rezultata
English: Dizziness has been reported by some patients taking macimorelin.
Croatian: U nekih bolesnika koji su uzimali macimorelin zabilježena je omaglica.
English: The use of Macimorelin Aeterna Zentaris must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency.
Croatian: 4.2 Doziranje i način primjene Primjenu lijeka Macimorelin Aeterna Zentaris mora nadzirati liječnik ili zdravstveni radnik s iskustvom u dijagnosticiranju nedostatka hormona rasta.
English: Step 5
Croatian: 5. korak
English: Macimorelin showed a dose-dependent release of GH after oral dosing.
Croatian: Macimorelin je pokazao o dozi ovisno otpuštanje hormona rasta nakon peroralnog doziranja.
English: PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Croatian: Granule za oralnu suspenziju u vrećici.
English: Tell your doctor if you are taking medicines that may impact the accuracy of the diagnostic test. Avoid concomitant use with medicines:
Croatian: Obavijestite svojeg liječnika ako uzimate lijekove koji mogu utjecati na točnost dijagnostičkog testa.
English: Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus.
Croatian: downstream), pa u ranoj fazi hipotalamičke lezije otpuštanje rezerve pohranjenog hormona rasta iz prednjeg režnja hipofize, potaknuto macimorelinom, može dovesti do lažno negativnog rezultata.