FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Test je bil pozitiven (tj. diagnoza pomanjkanja rastnega hormona (GHD)), če je bila najvišja raven rastnega hormona v serumu po stimulaciji manjša od vnaprej določene mejne vrednosti 2,8 ng/ml pri testu MAC oziroma 5,1 ng/ml pri testu ITT.
English: • type 2 diabetes (pioglitazone)
Slovenian: • sladkorne bolezni tipa 2 (pioglitazon);
English: In case you should have heart rhythm disturbances, an ECG monitoring will be performed.
Slovenian: Če imate motnje srčnega ritma, vas bo spremljali z
English: Tell your doctor if you are taking medicines that could increase the breakdown of macimorelin such as specific medicines to treat:
Slovenian: Obvestite zdravnika, če jemljete zdravila, ki bi lahko povečala razkroj macimorelina, kot so določena zdravila za zdravljenje:
English: If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded.
Slovenian: Če se macimorelin daje bolnikom z okvaro ledvic in/ali jeter, ni mogoče izključiti možnosti za zvišano raven macimorelina v plazmi.
English: The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2).
Slovenian: Varnosti in učinkovitosti macimorelina pri bolnikih z okvaro ledvic in/ali jeter niso dokazali (glejte tudi poglavje 5.2).
English: In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1).
Slovenian: QTc > 500 ms moramo spremljati EKG (glejte poglavji 4.4 in 5.1).
English: 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.
Slovenian: Klinične študije so pokazale, da maksimalna stimulirana raven rastnega hormona v serumu, ki je po uporabi macimorelina nižja od 2,8 ng/ml (pri časovnih točkah 45, 60 in 90 minut), potrjuje diagnozo pomanjkanja rastnega hormona pri odraslih bolnikih.
English: • mild to moderate depressive episodes (St. John´s wort (Hypericum perforatum))
Slovenian: • blagih do zmernih depresivnih epizod (šentjanževka (Hypericum perforatum));
English: Talk to your doctor or nurse if:
Slovenian: Z zdravnikom ali medicinsko sestro se posvetujte v naslednjih primerih:
English: Macimorelin is not recommended during pregnancy.
Slovenian: Macimorelin v nosečnosti ni priporočljiv.
English: Other hormone deficiencies if untreated could lead to inaccurate results in the growth hormone stimulation test.
Slovenian: Druga nezdravljena pomanjkanja hormonov lahko privedejo do nenatančnih rezultatov pri testu s stimulacijo rastnega hormona.
English: Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1).
Slovenian: Zdravilo Macimorelin Aeterna Zentaris je indicirano za diagnosticiranje pomanjkanja rastnega hormona (GHD, growth hormone deficiency) pri odraslih (glejte poglavje 5.1).
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.
Slovenian: Pri bolnikih z znanim prirojenim ali pridobljenim sindromom dolgega intervala QT in pri bolnikih s tahikardijo torsades de pointes v anamnezi se lahko dajanje macimorelina izvede le na kardiovaskularnem kliničnem oddelku.
English: Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream.
Slovenian: Macimorelin deluje kot naravni hormon in povzroča, da hipofiza izloča rastni hormon v krvni obtok.
English: 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).
Slovenian: V tej študiji so dokazali povprečno spremembo intervala QTcF, korigirano glede na izhodiščno vrednost in na placebo (zgornja meja enostranskega 95-odstotnega intervala zaupanja), v višini 9,6 ms (11,4 ms) 4 h po odmerku (glejte tudi poglavje 4.4), ki se je pojavila po tem, ko je bila dosežena povprečna največja koncentracija macimorelina v plazmi (0,5 h).
English: 1 mL of the reconstituted suspension contains 500 micrograms macimorelin.
Slovenian: 1 ml rekonstituirane suspenzije vsebuje 500 mikrogramov macimorelina.
English: 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.
Slovenian: Uporaba induktorja CYP3A4 (kot so karbamazepin, dabrafenib, efavirenz, enzalutamid, eslikarbazepin, fosfenitoin, lumakaftor, modafinil, nevirapin, okskarbazepin, fenobarbital, fenitoin, pioglitazon, pitolizant, primidon, rifabutin, rifampicin in šentjanževka (Hypericum perforatum)) lahko zmanjša koncentracije macimorelina v plazmi in lahko vpliva na diagnostično uspešnost testa, zato se moramo sočasni uporabi izogibati.
English: The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Slovenian: Mejna vrednost za preiskavo z macimorelinom v prehodnem obdobju od pozne pubertete do odraslosti ni bila ugotovljena.
English: The use of Macimorelin Aeterna Zentaris must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency.
Slovenian: Uporabo zdravila Macimorelin Aeterna Zentaris mora nadzorovati zdravnik ali zdravstveni delavec, ki ima izkušnje z diagnosticiranjem pomanjkanja rastnega hormona.
English: If the adult growth hormone deficiency just recently started and if it is due to an injury in a section of the brain called hypothalamus, then the test result could be negative although you have the disease.
Slovenian: Če se je pomanjkanje rastnega hormona v odrasli dobi šele pred kratkim pojavilo in če je posledica poškodbe v delu možganov, imenovanem hipotalamus, bi lahko bil rezultat preiskave negativen,
English: 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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Macimorelin Aeterna Zentaris za eno ali več podskupin pediatrične populacije pri diagnostiki pomanjkanja rastnega hormona (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: 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.
Slovenian: Pri teh bolnikih je lahko indicirana kontrola z EKG pred dajanjem macimorelina ter 1 uro, 2 uri, 4 ure in 6 ur po dajanju macimorelina.
English: In a diagnostic study comparing macimorelin with the insulin tolerance test (ITT) stimulated GH concentrations after macimorelin were on average 1.4 fold higher than in the ITT.
Slovenian: V diagnostični študiji, v kateri so primerjali macimorelin z insulinskim tolerančnim testom (ITT), so bile koncentracije spodbujenega rastnega hormona po uporabi macimorelina v povprečju 1,4-krat višje kot s testom ITT.
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).
Slovenian: • Če imate srčno bolezen ali težave s srčnim ritmom (vključno s prirojenim ali pridobljenim sindromom dolgega intervala QT ali t.i. tahikardijo torsades de pointes v zdravstveni zgodovini).
English: 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
Slovenian: Zahtevani material: vrečica zdravila Macimorelin Aeterna Zentaris, voda iz pipe v dekanterju, graduirana steklena ali prozorna plastična posoda, pripomoček za mešanje, 50-ml graduirana brizga brez igle, kozarec 1. korak
English: Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije vpliva na sposobnost razmnoževanja na živalih niso zadostne (glejte poglavje 5.3).
English: Instructions are given at the end of this leaflet on how to prepare the test.
Slovenian: Navodila za izvedbo preiskave so navedena na koncu tega navodila.
English: Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively.
Slovenian: Točkovni oceni občutljivosti oziroma specifičnosti sta bili 87 % oziroma 96 % pri neujemajočih se preiskovancih iz skupine A.
English: Adult population
Slovenian: Odmerjanje Odrasla populacija
English: The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
Slovenian: Celotno vsebino vrečice raztopimo v 120 ml, dve vrečici pa raztopimo v 240 ml, kakor je ustrezno.
English: Any unused medicine or waste material should be disposed in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Slovenian: Vsebuje 60 mg macimorelina (v obliki acetata) Po rekonstituciji: 500 mikrogramov macimorelina/ml
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.
Slovenian: Macimorelin deluje nizvodno od hipotalamusa, zato lahko z macimorelinom stimulirano sproščanje shranjenih zalog rastnega hormona iz sprednjega režnja hipofize povzroči lažno negativen rezultat v zgodnji fazi, kadar lezija obsega hipotalamus.
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).
Slovenian: občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Slovenian: Diagnostična uspešnost zdravila Macimorelin Aeterna Zentaris je bila ugotovljena v randomizirani, neslepi, križni študiji z enkratnim odmerkom (AEZS-130052), v kateri so primerjali ujemanje med rezultati testa z macimorelinom (MAC) in insulinskega tolerančnega testa (ITT).
English: Point estimates for sensitivity ranged from 0.87 to 0.90 for the MAC and from 0.97 to 1.0 for the ITT, depending on the inclusion or exclusion of data from not matched Group A subjects, respectively.
Slovenian: Točkovne ocene občutljivosti so se gibale od 0,87 do 0,90 za MAC in od 0,97 do 1,0 za ITT, odvisno od vključitve ali izključitve podatkov neujemajočih se preiskovancev iz skupine A. Ocena specifičnosti je bila za oba testa GHST 0,96, ne glede na vključitev ali izključitev podatkov neujemajočih se preiskovancev iz skupine A.
English: Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone.
Slovenian: Zdravilo Macimorelin Aeterna Zentaris se uporablja pri odraslih za preverjanje sposobnosti telesa za tvorbo rastnega hormona.
English: Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.
Slovenian: Celotno vsebino vrečice raztopite v vodi: eno vrečico v 120 ml, dve vrečici v 240 ml, kot je potrebno.
English: Strong CYP3A4 inducers should be discontinued and a washout time of five elimination half-lives should be considered prior to test administration.
Slovenian: Uporabo močnih induktorjev CYP3A4 moramo prekiniti in pred dajanjem diagnostičnega zdravila zagotoviti obdobje izpiranja v trajanju petih razpolovnih dob izločanja.
English: The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Slovenian: Volumen suspenzije v ml je enak bolnikovi telesni masi v kg. Na primer, bolnik s 70 kg potrebuje 70 ml suspenzije macimorelina.
English: Macimorelin should be used with caution in patients with proarrhythmic condition (e.g., history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
Slovenian: Macimorelin moramo uporabljati previdno pri bolnikih s proaritmičnim stanjem (npr. z miokardnim infarktom, srčnim popuščanjem ali podaljšanim intervalom QTc na EKG, opredeljenim kot QTc > 500 ms, v anamnezi).
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.
Slovenian: Negativno oziroma pozitivno ujemanje med testoma MAC oziroma ITT pri preiskovancih z vmesnim ali nizkim tveganjem (skupini B in C) je bilo 93 % oziroma 61 %, spodnji meji 95-odstotnega intervala zaupanja pa 80 % oziroma 43 %.
English: A sufficient washout time of five elimination half-lives of the CYP3A4 inducer prior to administration of the test is recommended (see section 4.2 and section 4.4).
Slovenian: Priporočljivo je, da pred dajanjem diagnostičnega zdravila zagotovimo zadosten čas izpiranja, ki traja pet razpolovnih dob izločanja induktorja CYP3A4 (glejte poglavje 4.2 in poglavje 4.4).
English: The level of negative and positive agreement between the results of the ITT and the MAC test was used to evaluate the performance of the MAC test.
Slovenian: Za oceno uspešnosti testa MAC so uporabili stopnjo negativnega in pozitivnega ujemanja med rezultati testov ITT in MAC.
English: This corresponds to a volume of 1 mL of the prepared suspension per kg body weight.
Slovenian: To ustreza prostornini 1 ml pripravljene suspenzije na kg telesne mase.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vrečici poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
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).
Slovenian: Eksogeni rastni hormoni ali zdravila, ki neposredno vplivajo na hipofizo, lahko vplivajo na somatotropno funkcijo hipofize in povzročijo nezanesljive rezultate stimulacije rastnega hormona (glejte tudi poglavji 4.2 in 4.5).
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)).
Slovenian: Podobno podaljšanje intervala QTcF so ugotovili tudi v študiji z enkratnimi odmerki, ki je obsegala tri naraščajoče ravni odmerka (0,5 mg/kg, 1 mg/kg in 2 mg/kg (2-kratni oziroma 4-kratni priporočeni odmerek)).
English: These results are based on peak GH values (maximum GH concentrations across all measurement timepoints).
Slovenian: Ti rezultati temeljijo na vrhovih ravni rastnega hormona (največji koncentraciji rastnega hormona v celotnem obdobju meritev).
English: The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight.
Slovenian: Priporočeni odmerek je 0,5 mg zdravila Macimorelin Aeterna Zentaris na kg telesne mase.
English: The suspension must be taken within 30 minutes after preparation.
Slovenian: Suspenzijo je treba dati v 30 minutah po pripravi.
English: The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively.
Slovenian: Oceni negativnega oziroma pozitivnega ujemanja sta bili 95 % oziroma 86 %, spodnji meji 95-odstotnega intervala zaupanja pa 87 % oziroma 75 %.
English: A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively.
Slovenian: Tekoči obrok je zmanjšal vrednost Cmax macimorelina za 0,42-krat, vrednost AUC pa za 0,5-krat.
English: In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
Slovenian: Pri bolnikih, starih od 18 do 25 let, je bila diagnostična uspešnost preiskav z MAC in ITT primerljiva.
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1).
Slovenian: Macimorelin povzroči podaljšanje popravljenega intervala QT (QTc) za približno 11 ms z neznanim mehanizmom (glejte tudi poglavje 5.1).
English: • HIV (efavirenz, nevirapine)
Slovenian: • okužbe s HIV (efavirenz, nevirapin);
English: The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Slovenian: Volumen suspenzije v ml, ki je potreben za priporočeni odmerek macimorelina 0,5 mg/kg, je enak bolnikovi telesni masi v kg. Na primer, bolnik s 70 kg potrebuje 70 ml suspenzije macimorelina.
English: Residual suspension must be discarded according to local regulations.
Slovenian: Preostalo suspenzijo zavrzite v skladu z lokalnimi predpisi.
English: Each sachet contains 60 mg macimorelin (as acetate).
Slovenian: Ena vrečica vsebuje 60 mg macimorelina (v obliki acetata).
English: • medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
Slovenian: • zdravila za popravljanje srčnega ritma (antiaritmiki, kot so amiodaron, prokainamid, kinidin ali sotalol);
English: Macimorelin is moderately bound to plasma proteins.
Slovenian: Vezava macimorelina na beljakovine v plazmi je zmerna.
English: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process.
Slovenian: Pomanjkanja rastnega hormona pri odraslih bolnikih, ki ga povzroči hipotalamična lezija, v zgodnji fazi bolezni ne moremo odkriti.
English: Please ask your doctor whether to discontinue breast-feeding or to abstain from the macimorelin test.
Slovenian: Posvetujte se z zdravnikom glede prenehanja dojenja ali opustitve preiskave z macimorelinom.
English: These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5).
Slovenian: Te učinkovine lahko privedejo do nezanesljivih rezultatov stimulacije rastnega hormona (glejte tudi poglavji 4.4 in 4.5).
English: In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
Slovenian: Pri bolnikih z visoko vrednostjo ITM do 40 kg/m2 je bila diagnostična uspešnost preiskav z MAC in ITT primerljiva.
English: CYP3A4 is the major enzyme to metabolize macimorelin.
Slovenian: CYP3A4 je glavni encim, ki presnavlja macimorelin.
English: • Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
Slovenian: • zdravila, ki lahko prehodno zvišajo koncentracijo rastnega hormona (kot so klonidin, levodopa in insulin);
English: The concomitant use with medicinal products that are known to induce torsades de pointes should be avoided (see also section 4.5).
Slovenian: Preprečiti moramo sočasno uporabo z zdravili, za katera je znano, da inducirajo torsades de pointes (glejte tudi poglavje 4.5).
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.
Slovenian: • Vnos tekočine - dovoljen je vnos največ 100 ml negazirane vode v 1 uri pred preiskavo in v 1 uri po prejemu macimorelina.
English: A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Slovenian: Možnosti povečane peroralne biološke uporabnosti in koncentracije macimorelina v plazmi pri uporabi močnih zaviralcev CYP3A4/P-gp ni mogoče izključiti.
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.
Slovenian: Oceni negativnega oziroma pozitivnega ujemanja med testoma MAC oziroma ITT v celotni preučevani populaciji sta bili 94 % oziroma 74 %, spodnji meji 95-odstotnega intervala zaupanja pa 85 % oziroma 63 %.
English: Possible side effects in cases of overdosing could include headache, nausea, vomiting and diarrhoea.
Slovenian: Možni neželeni učinki v primeru prevelikega odmerjanja lahko vključujejo glavobol, siljenje na bruhanje, bruhanje in drisko.
English: • seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
Slovenian: • epileptičnih napadov/epilepsije (karbamazepin, esklikarbazepin, fosfenitoin, okskarbazepin,
English: If you are given more Macimorelin Aeterna Zentaris than you should, tell your doctor or nurse.
Slovenian: Če ste prejeli večji odmerek zdravila Macimorelin Aeterna Zentaris, kot bi smeli Če ste prejeli večji odmerek zdravila Macimorelin Aeterna Zentaris, kot bi smeli, obvestite zdravnika ali medicinsko sestro.
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).
Slovenian: Možnost lažno pozitivnih rezultatov testa pri uporabi močnih induktorjev CYP3A4 Sočasna uporaba močnih induktorjev CYP3A4 z zdravilom Macimorelin Aeterna Zentaris lahko znatno zmanjša koncentracije macimorelina v plazmi in tako povzroči lažno pozitiven rezultat (glejte tudi poglavje 4.5).
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.
Slovenian: Ocenili so občutljivost in specifičnost obeh testov stimulacije rastnega hormona (GHST, growth hormone stimulation test) ob predpostavki, da so vsi preiskovanci z visoko verjetnostjo pomanjkanja rastnega hormona pri odraslih iz skupine A „resnično“ preiskovanci s pomanjkanjem rastnega hormona pri odraslih ter da so vsi zdravi ujemajoči se preiskovanci iz skupine D „resnično“ osebe brez pomanjkanja rastnega hormona pri odraslih.
English: Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.
Slovenian: Macimorelin spodbuja sproščanje rastnega hormona z aktiviranjem receptorjev sekretagogov rastnega hormona (GHSR, growth hormone secretagogue receptors), ki so prisotni v hipofizi in hipotalamusu.
English: The following medicinal products may impact the accuracy of the diagnostic test. Concomitant use is to be avoided with (see also section 4.2 and section 4.4):
Slovenian: Zdravila, ki vplivajo na sproščanje rastnega hormona Naslednja zdravila lahko vplivajo na točnost diagnostičnega testa, zato se moramo sočasni uporabi izogibati (glejte tudi poglavje 4.2 in poglavje 4.4):