natgillin/translations-raw huggingface dataset:
Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg.
Odredite volumen suspenzije potreban za preporučenu dozu macimorelina od 0,5 mg/kg.
If you are given more Macimorelin Aeterna Zentaris than you should, tell your doctor or nurse.
Ako ste primili više lijeka Macimorelin Aeterna Zentaris nego što ste trebali, obratite se liječniku ili medicinskoj sestri.
Potential for false positive test results with use of strong CYP3A4 inducers
Mogućnost lažno pozitivnih rezultata uz primjenu snažnih induktora enzima CYP3A4
Clinical studies have established that a maximally stimulated serum GH level of less than 2.8 ng/mL (at the 45, 60 and 90 minutes timepoints) following macimorelin administration confirms a diagnosis of adult growth hormone deficiency.
U kliničkim ispitivanjima utvrđeno je da razina maksimalno stimuliranog hormona rasta u serumu manja od 2,8 ng/ml (u vremenskim točkama 45, 60 i 90 minuta) nakon primjene macimorelina potvrđuje dijagnozu nedostatka hormona rasta u odraslih.
The suspension must be prepared and administered by a healthcare professional.
UPUTE ZA PRIPREMU I UPOTREBU Suspenziju mora pripremiti i primijeniti zdravstveni radnik.
Therefore, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin (see also section 4.4).
Stoga mogu biti indicirane kontrole EKG-a prije primjene macimorelina te 1 sat, 2 sata, 4 sata i 6 sati poslije primjene macimorelina (vidjeti također dio 4.4).
There are no data for the use of macimorelin in pregnant women.
Nema podataka o primjeni macimorelina u trudnica.
You must be fasting for at least 8 hours before you are given Macimorelin Aeterna Zentaris.
Morate biti natašte najmanje 8 sati prije nego što primite lijek Macimorelin Aeterna Zentaris.
• sleep disorder (modafinil, pitolisant)
• poremećaja spavanja (modafinil, pitolizant)
• cancer (dabrafenib, enzalutamide)
• karcinoma (dabrafenib, enzalutamid).
• seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
• napadaja/epilepsije (karbamazepin, eslikarbazepin, fosfenitoin, okskarbazepin, fenobarbital, fenitoin, primidon)
Studies to detect macimorelin metabolites did not identify any metabolites.
U ispitivanjima provedenima kako bi se detektirali metaboliti macimorelina nije pronađen nijedan metabolit.
Items needed: Macimorelin Aeterna Zentaris sachet, tap water in decanter, graduated glass or transparent plastic container, stirring device, 50 mL graduated syringe without needle, drinking glass
Potreban pribor: vrećica lijeka Macimorelin Aeterna Zentaris, voda iz slavine u staklenoj posudi (dekanteru), graduirana staklena ili prozirna plastična posuda, pribor za miješanje, graduirana štrcaljka od 50 ml bez igle, čaša.
If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris.
Ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite Macimorelin
All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes.
U temeljitom ispitivanju QT intervala sve tri ispitivane razine doze pokazale su sličnu magnitudu produljenja QTcF-a, što upućuje na odsutnost promjena ovisnih o dozi.
Instructions are given at the end of this leaflet on how to prepare the test.
Upute o tome kako se priprema test nalaze se na kraju ove upute o lijeku.
Unopened sachet
Neotvorena vrećica
Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone.
Macimorelin Aeterna Zentaris upotrebljava se u odraslih za testiranje sposobnosti tijela da proizvodi hormon rasta.
Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process.
Nedostatak hormona rasta u odrasloj dobi prouzročen hipotalamičkom lezijom možda neće biti otkriven rano u procesu bolesti.
Both co-primary endpoints as pre-defined in Study 052 (lower limit of the 95% CI for negative agreement ≥ 75%, lower limit of the 95% CI for positive agreement ≥ 70%) are met when using an ITT cut-off point of 3.0 ng/mL and the pre-defined cut-off point for the MAC of 2.8 ng/mL.
Obje koprimarne mjere ishoda unaprijed definirane u ispitivanju 052 (donja granica 95 %-tnog intervala pouzdanosti za negativno slaganje ≥ 75 %, donja granica 95 %-tnog intervala pouzdanosti za pozitivno slaganje ≥ 70 %) bile su ispunjene uz upotrebu granične vrijednosti ITT testa od 3,0 ng/ml i uz unaprijed definiranu graničnu vrijednost MAC testa od 2,8 ng/ml.
• HIV (efavirenz, nevirapine)
• HIV-a (efavirenz, nevirapin)
Possible side effects in cases of overdosing could include headache, nausea, vomiting and diarrhoea.
Moguće nuspojave u slučaju predoziranja mogu uključivati glavobolju, mučninu, povraćanje i proljev.
In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
U bolesnika u dobi od 18 do 25 godina dijagnostička uspješnost testova MAC i ITT bile su slične.
• you have recently been treated for Cushing's disease (disorder which results in high levels of the hormone cortisol) or if you are receiving a high dose of hydrocortisone medicine, the test may lead to false positive test results.
• ako ste nedavno bili liječeni zbog Cushingove bolesti (poremećaj koji ima za posljedicu visoke razine hormona kortizola) ili ako primate visoke doze hidrokortizona; u tom slučaju test može dovesti do lažno pozitivnih rezultata
Further possible undesirable effects in case of overdosing could include headache, nausea, vomiting and diarrhoea.
Daljnje moguće nuspojave u slučaju predoziranja mogu uključivati glavobolju, mučninu, povraćanje i proljev.
Administration of a CYP3A4 inducer (such as carbamazepine, dabrafenib, efavirenz, enzalutamide, eslicarbazepine, fosphenytoin, lumacaftor, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, pitolisant, primidone, rifabutin, rifampicin and St John's wort (Hypericum perforatum)) may reduce the plasma macimorelin concentrations and may affect the diagnostic performance of the test and therefore should be avoided.
Primjena induktora enzima CYP3A4 (kao što su karbamazepin, dabrafenib, efavirenz, enzalutamid, eslikarbazepin, fosfenitoin, lumakaftor, modafinil, nevirapin, okskarbazepin, fenobarbital, fenitoin, pioglitazon, pitolizant, primidon, rifabutin, rifampicin i gospina trava (Hypericum perforatum)) može sniziti koncentracije macimorelina u plazmi i utjecati na dijagnostičku uspješnost testa, pa je stoga treba izbjegavati.
Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream.
Macimorelin djeluje kao prirodni hormon i potiče žlijezdu hipofizu na otpuštanje hormona rasta u krvotok.
The test was considered positive (i.e., growth hormone deficiency (GHD) diagnosed) if the maximum serum GH level observed after stimulation was less than the pre-specified cut-off point of 2.8 ng/mL for the MAC test or 5.1 ng/mL for the ITT.
Test se smatrao pozitivnim (tj. dijagnosticiran je nedostatak hormona rasta) ako je maksimalna razina hormona rasta u serumu opažena nakon stimulacije bila niža od unaprijed određene granične vrijednosti od 2,8 ng/ml u MAC testu ili 5,1 ng/ml u ITT testu.
Before using Macimorelin Aeterna Zentaris it is important to ensure that the patient is in fasting condition for at least 8 hours and did not have strenuous physical exercises 24 hours before the test, since both could affect GH levels.
Prije primjene lijeka Macimorelin Aeterna Zentaris važno je potvrditi da je bolesnik natašte najmanje 8 sati te da nije poduzimao naporne tjelesne aktivnosti 24 sata prije testa jer oboje može utjecati na razine hormona rasta.
At the clinically relevant concentration of 0.1 µM (clinical Cmax = 11.2 ng/ml = approx. 0.02 µM), the unbound fraction of macimorelin in human plasma is
Pri klinički relevantnoj koncentraciji od 0,1 µM (klinički Cmax = 11,2 ng/ml = približno 0,02 µM), nevezana frakcija macimorelina u ljudskoj plazmi iznosi 22 %.
Any unused medicine or waste material should be disposed in accordance with local requirements.
Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1).
QTc > 500 ms, potrebno je praćenje EKG-a (vidjeti dijelove 4.4 i 5.1).
Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1).
Lijek Macimorelin Aeterna Zentaris indiciran je za dijagnosticiranje nedostatka hormona rasta (engl. growth hormone deficiency, GHD) u odraslih (vidjeti dio 5.1).
This study showed a mean baseline- and placebo-adjusted change (upper single-sided 95% confidence interval) in QTcF of 9.6 ms (11.4 ms) at 4 h post-dose (see also section 4.4), which occurred after the mean maximum macimorelin plasma concentration (0.5 h).
Ispitivanje je pokazalo srednju vrijednost promjene prilagođene u odnosu na početnu vrijednost i placebo (gornja granica jednostranog intervala pouzdanosti od 95 %) u QTcF-u od 9,6 ms (11,4 ms) 4 sata poslije doze (vidjeti također dio 4.4), što se pojavilo nakon srednje vrijednosti maksimalne koncentracije macimorelina u plazmi (0,5 h).
Macimorelin Aeterna Zentaris is not recommended during pregnancy.
Macimorelin Aeterna Zentaris ne preporučuje se tijekom trudnoće.
For such patients, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin.
U takvih bolesnika mogu biti indicirane kontrole EKG-a prije primjene macimorelina te 1 sat, 2 sata, 4 sata i 6 sati poslije primjene macimorelina.
Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL.
Maksimalno otpuštanje hormona rasta opaženo je pri koncentracijama macimorelina u plazmi od ≥ 7 ng/ml.
Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.
Rastopite cijeli sadržaj vrećice u vodi: jednu vrećicu u 120 ml, dvije vrećice u 240 ml, prema potrebi.
The EMA has deferred the obligation to submit the results of studies with Macimorelin Aeterna Zentaris in one or more subsets of the paediatric population in the diagnosis of growth hormone deficiency (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Macimorelin Aeterna Zentaris u jednoj ili više podskupina pedijatrijske populacije u dijagnosticiranju nedostatka hormona rasta (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
• your body is lacking any other hormone e.g. cortisol, thyroid or sex hormones, vasopressin (in diabetes insipidus), this should be adequately replaced before testing for growth hormone deficiency.
• ako Vašem tijelu nedostaje neki drugi hormon, npr. kortizol, hormoni štitnjače ili spolni hormoni, vazopresin (kod insipidnog dijabetesa); to treba odgovarajuće nadomjestiti prije provedbe testa na nedostatak hormona rasta.
These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
Te abnormalnosti EKG-a činila su odstupanja T-vala i produljenje QT intervala (vidjeti također dio 4.4).
Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP.
Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza oznake
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.
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.
These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5).
Te tvari mogu dovesti do nepouzdanih rezultata za stimulaciju hormona rasta (vidjeti također dijelove 4.4 i 4.5).
For both GHSTs, the estimated specificity was 0.96, irrespective of the in/exclusion data from not matched Group A subjects.
U oba testa stimulacije hormona rasta, procijenjena specifičnost bila je 0,96 bez obzira na uključivanje/isključivanje nepodudarnih ispitanika iz skupine A.
Strong CYP3A4 inducers should be discontinued and a washout time of five elimination half-lives should be considered prior to test administration.
Primjenu snažnih induktora enzima CYP3A4 treba prekinuti i prije primjene testa razmotriti vrijeme ispiranja lijeka od pet poluvjekova eliminacije.
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).
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).
• medicines to treat infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
• lijekovi za liječenje infekcija (antibiotici kao što je eritromicin, klaritromicin, moksifloksacin)
If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded.
Ako se macimorelin primijeni u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije, ne može se isključiti mogućnost povišene koncentracije macimorelina u plazmi.
The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively.
Procjene negativnog i pozitivnog slaganja iznosile su 95 % odnosno 86 %, s donjom granicom 95 %-tnog intervala pouzdanosti od 87 % odnosno 75 %.
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).
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).
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.
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 %.
• 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).
• 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).
Macimorelin Aeterna Zentaris has minor influence on the ability to drive and use machines.
Macimorelin Aeterna Zentaris malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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).
• ako ste alergični na macimorelin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
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.
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.
Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin.
Maksimalne razine hormona rasta opažene su približno 45 do 60 minuta nakon primjene macimorelina.
This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po vrećici, tj. zanemarive količine natrija.
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.
Ako se na dno slegne nešto čestica, kao na primjer kada se suspenziju ostavi stajati neko vrijeme, suspenziju je potrebno ponovno promiješati.
The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2.
Sigurnost primjene i dijagnostička uspješnost macimorelina u bolesnika s indeksom tjelesne mase ITM > 40 kg/m2 nisu utvrđene.
The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years.
Farmakodinamika macimorelina nije zadovoljavajuće procijenjena u starije populacije u dobi
If you are given more Macimorelin Aeterna Zentaris than you should
Ako ste primili više lijeka Macimorelin Aeterna Zentaris nego što ste trebali
QTc prolongation
Produljenje QTc intervala
A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively.
Tekući obrok smanjio je Cmax macimorelina 0,42 puta te AUC 0,5 puta.
The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
Cjelokupni sadržaj jedne vrećice rastopi se u 120 ml, dok se dvije vrećice rastope u 240 ml, prema potrebi.
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)).
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)).
Each sachet contains 1,817 mg granules.
Jedna vrećica sadrži 1817 mg granula.
Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin
Prekid terapije hormonom rasta ili lijekom koji izravno utječe na lučenje somatotropina iz hipofize
A dose of 0.5 mg/kg macimorelin was shown to induce maximal GH release.
Pokazalo se da doza od 0,5 mg/kg macimorelina izaziva maksimalno otpuštanje hormona rasta.
Residual suspension must be discarded according to local regulations.
Ostatak suspenzije mora se baciti sukladno nacionalnim propisima.
Co-administration of a CYP3A4 inhibitor may increase the macimorelin plasma concentration, and this, in turn, could yield higher plasma GH levels.
Istodobna primjena inhibitora enzima CYP3A4 može povećati koncentraciju macimorelina u plazmi, a to bi zauzvrat moglo proizvesti veće koncentracije hormona rasta u plazmi.
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.
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.
Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
A saharinnatrij dihidrat natrijev stearilfumarat
The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Granična vrijednost macimorelina u prijelaznom razdoblju od kasnog puberteta do pune zrelosti odrasle dobi nije utvrđena.
• Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
• s lijekovima koji privremeno mogu povisiti koncentracije hormona rasta (kao što su klonidin, levodopa i inzulin)
Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.
Macimorelin stimulira otpuštanje hormona rasta aktivacijom sekretagognih receptora hormona rasta prisutnih u hipofizi i hipotalamusu.
• 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).
• s lijekovima koji mogu oslabiti odgovor hormona rasta na macimorelin (kao što su muskarinski antagonisti: atropin, antitiroidni lijekovi: propiltiouracil i lijekovi za hormon rasta).
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).
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).
D-60314 Frankfurt am Main, Germany
D-60314 Frankfurt am Main, Njemačka
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).
< 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
An in vitro human liver microsomes study showed that CYP3A4 is the major enzyme to metabolize macimorelin.
Ispitivanje na ljudskim jetrenim mikrosomima in vitro pokazalo je da je CYP3A4 glavni enzim kojim se metabolizira macimorelin.
For both the ITT and the MAC test, serum concentrations of GH were measured at 30, 45, 60 and 90 minutes after administration.
U oba testa, ITT i MAC testu, koncentracije hormona rasta u serumu izmjerene su 30, 45, 60 i 90 minuta nakon primjene.
1 mL of the reconstituted suspension contains 500 micrograms macimorelin.
Jedan (1) ml rekonstituirane suspenzije sadrži 500 mikrograma macimorelina.
What Macimorelin Aeterna Zentaris is and what it is used for 2.
Što je Macimorelin Aeterna Zentaris i za što se koristi 2.
Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1).
Macimorelin uzrokuje produljenje korigiranog QT intervala (QTc) za oko 11 ms (vidjeti dio 5.1).
• Drinking - up to 100 mL of still water is allowed each within 1 hour before as well as within 1 hour after macimorelin intake.
• unos tekućine - dopušteno je do 100 ml obične vode unutar 1 sata prije te 1 sata poslije unosa macimorelina.
• lower than normal heart rate (sinus bradycardia)
• osjećaj lupanja srca • sporiji srčani otkucaji nego što je normalno (sinusna bradikardija)
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.
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 %