natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
• 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). 
• 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).
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 
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
Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3). 
Študije vpliva na sposobnost razmnoževanja na živalih niso zadostne (glejte poglavje 5.3).
Instructions are given at the end of this leaflet on how to prepare the test. 
Navodila za izvedbo preiskave so navedena na koncu tega navodila.
Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively. 
Točkovni oceni občutljivosti oziroma specifičnosti sta bili 87 % oziroma 96 % pri neujemajočih se preiskovancih iz skupine A.
Adult population 
Odmerjanje Odrasla populacija
The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable. 
Celotno vsebino vrečice raztopimo v 120 ml, dve vrečici pa raztopimo v 240 ml, kakor je ustrezno.
Any unused medicine or waste material should be disposed in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL 
Vsebuje 60 mg macimorelina (v obliki acetata) Po rekonstituciji: 500 mikrogramov macimorelina/ml
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. 
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.
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). 
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).
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. 
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).
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. 
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.
Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone. 
Zdravilo Macimorelin Aeterna Zentaris se uporablja pri odraslih za preverjanje sposobnosti telesa za tvorbo rastnega hormona.
Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable. 
Celotno vsebino vrečice raztopite v vodi: eno vrečico v 120 ml, dve vrečici v 240 ml, kot je potrebno.
Strong CYP3A4 inducers should be discontinued and a washout time of five elimination half-lives should be considered prior to test administration. 
Uporabo močnih induktorjev CYP3A4 moramo prekiniti in pred dajanjem diagnostičnega zdravila zagotoviti obdobje izpiranja v trajanju petih razpolovnih dob izločanja.
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. 
Volumen suspenzije v ml je enak bolnikovi telesni masi v kg. Na primer, bolnik s 70 kg potrebuje 70 ml suspenzije macimorelina.
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). 
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).
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 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 %.
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). 
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).
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. 
Za oceno uspešnosti testa MAC so uporabili stopnjo negativnega in pozitivnega ujemanja med rezultati testov ITT in MAC.
This corresponds to a volume of 1 mL of the prepared suspension per kg body weight. 
To ustreza prostornini 1 ml pripravljene suspenzije na kg telesne mase.
Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP. 
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.
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). 
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).
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)). 
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)).
These results are based on peak GH values (maximum GH concentrations across all measurement timepoints). 
Ti rezultati temeljijo na vrhovih ravni rastnega hormona (največji koncentraciji rastnega hormona v celotnem obdobju meritev).
The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight. 
Priporočeni odmerek je 0,5 mg zdravila Macimorelin Aeterna Zentaris na kg telesne mase.
The suspension must be taken within 30 minutes after preparation. 
Suspenzijo je treba dati v 30 minutah po pripravi.
The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively. 
Oceni negativnega oziroma pozitivnega ujemanja sta bili 95 % oziroma 86 %, spodnji meji 95-odstotnega intervala zaupanja pa 87 % oziroma 75 %.
A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively. 
Tekoči obrok je zmanjšal vrednost Cmax macimorelina za 0,42-krat, vrednost AUC pa za 0,5-krat.
In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable. 
Pri bolnikih, starih od 18 do 25 let, je bila diagnostična uspešnost preiskav z MAC in ITT primerljiva.
Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1). 
Macimorelin povzroči podaljšanje popravljenega intervala QT (QTc) za približno 11 ms z neznanim mehanizmom (glejte tudi poglavje 5.1).
• HIV (efavirenz, nevirapine) 
• okužbe s HIV (efavirenz, nevirapin);
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. 
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.
Residual suspension must be discarded according to local regulations. 
Preostalo suspenzijo zavrzite v skladu z lokalnimi predpisi.
Each sachet contains 60 mg macimorelin (as acetate). 
Ena vrečica vsebuje 60 mg macimorelina (v obliki acetata).
• medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol) 
• zdravila za popravljanje srčnega ritma (antiaritmiki, kot so amiodaron, prokainamid, kinidin ali sotalol);
Macimorelin is moderately bound to plasma proteins. 
Vezava macimorelina na beljakovine v plazmi je zmerna.
Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process. 
Pomanjkanja rastnega hormona pri odraslih bolnikih, ki ga povzroči hipotalamična lezija, v zgodnji fazi bolezni ne moremo odkriti.
Please ask your doctor whether to discontinue breast-feeding or to abstain from the macimorelin test. 
Posvetujte se z zdravnikom glede prenehanja dojenja ali opustitve preiskave z macimorelinom.
These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5). 
Te učinkovine lahko privedejo do nezanesljivih rezultatov stimulacije rastnega hormona (glejte tudi poglavji 4.4 in 4.5).
In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable. 
Pri bolnikih z visoko vrednostjo ITM do 40 kg/m2 je bila diagnostična uspešnost preiskav z MAC in ITT primerljiva.
CYP3A4 is the major enzyme to metabolize macimorelin. 
CYP3A4 je glavni encim, ki presnavlja macimorelin.
• Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin). 
• zdravila, ki lahko prehodno zvišajo koncentracijo rastnega hormona (kot so klonidin, levodopa in insulin);
The concomitant use with medicinal products that are known to induce torsades de pointes should be avoided (see also section 4.5). 
Preprečiti moramo sočasno uporabo z zdravili, za katera je znano, da inducirajo torsades de pointes (glejte tudi poglavje 4.5).
• Drinking - up to 100 mL of still water is allowed each within 1 hour before as well as within 1 hour after macimorelin intake. 
• Vnos tekočine - dovoljen je vnos največ 100 ml negazirane vode v 1 uri pred preiskavo in v 1 uri po prejemu macimorelina.
A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded. 
Možnosti povečane peroralne biološke uporabnosti in koncentracije macimorelina v plazmi pri uporabi močnih zaviralcev CYP3A4/P-gp ni mogoče izključiti.
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. 
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 %.
Possible side effects in cases of overdosing could include headache, nausea, vomiting and diarrhoea. 
Možni neželeni učinki v primeru prevelikega odmerjanja lahko vključujejo glavobol, siljenje na bruhanje, bruhanje in drisko.
• seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone) 
• epileptičnih napadov/epilepsije (karbamazepin, esklikarbazepin, fosfenitoin, okskarbazepin,
If you are given more Macimorelin Aeterna Zentaris than you should, tell your doctor or nurse. 
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.
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). 
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).
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. 
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.
Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus. 
Macimorelin spodbuja sproščanje rastnega hormona z aktiviranjem receptorjev sekretagogov rastnega hormona (GHSR, growth hormone secretagogue receptors), ki so prisotni v hipofizi in hipotalamusu.
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): 
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):
In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable. 
Pri bolnikih, starih do 60 let, je bila diagnostična uspešnost v skupinah MAC in ITT primerljiva.
Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin. 
Najvišje ravni rastnega hormona so ugotovili približno 45 do 60 minut po dajanju macimorelina.
Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL. 
Največje izločanje rastnega hormona so ugotovili pri koncentracijah macimorelina v plazmi ≥ 7 ng/ml.
D-60314 Frankfurt am Main, Germany 
D-60314 Frankfurt am Main, Nemčija
Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1). 
Macimorelin povzroči podaljšanje popravljenega intervala QT (QTc) za približno 11 ms (glejte poglavje 5.1).
What Macimorelin Aeterna Zentaris is and what it is used for 2. 
Kaj je zdravilo Macimorelin Aeterna Zentaris in za kaj ga uporabljamo 2.
Each sachet contains 1,817 mg granules. 
Ena vrečica vsebuje 1.817 mg zrnc.
An in vitro human liver microsomes study showed that CYP3A4 is the major enzyme to metabolize macimorelin. 
Izločanje Študija in vitro z uporabo mikrosomskih preparatov človeških jeter je pokazala, da je CYP3A4 glavni encim, ki presnavlja macimorelin.
Medicinal products affecting growth hormone release 
Spodbujanje rastnega hormona
Dizziness has been reported by some patients taking macimorelin. 
Nekateri bolniki, ki so jemali macimorelin, so poročali o omotici.
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). 
Sočasnemu dajanju macimorelina z zdravili, ki lahko povzročijo torsades de pointes (antipsihotična zdravila, npr. klorpromazin, haloperidol, antibiotiki (npr. moksifloksacin, eritromicin, klaritromicin), antiaritmiki razreda Ia (npr. kinidin) in razreda III (npr. amiodaron, prokainamid, sotalol) ali katera koli druga zdravila, ki lahko povzročijo torsades de pointes) se moramo izogibati (glejte poglavje 4.4).
These ECG abnormalities consisted of T wave abnormalities and QT prolongation. 
Ti nepravilnosti na EKG sta obsegali nenormalne valove T in podaljšanje intervala QT.
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. 
Učinki macimorelina na parametre EKG so bili raziskani v posebej zasnovani študiji QT, ki so jo izvedli v trojni križni zasnovi s 60 zdravimi preiskovanci, pri katerih so primerjali supraterapevtski odmerek macimorelina (2 mg/kg, tj. 4-kratni priporočeni odmerek) s placebom in moksifloksacinom.
This medicinal product contains lactose. 
Vsebuje laktozo.
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. 
Bolniki s pomanjkanjem, ki vpliva na hormone, ki niso rastni hormon Pri bolnikih s pomanjkanjem, ki vplivajo na hormone, ki niso rastni hormon (npr. insuficienca nadledvičnih žlez, ščitnice in/ali gonad, diabetes insipidus), moramo uvesti ustrezno nadomestno zdravljenje z zadevnimi hormoni, preden izvedemo kakršno koli preiskavo za pomanjkanje rastnega hormona s stimulacijo, da izključimo neuspešno stimulacijo zaradi sekundarnega pomanjkanja rastnega hormona.
• you have recently been treated with growth hormone (somatotropin) or with medicines that affect the secretion of growth hormone by the pituitary gland. 
• Če ste se nedavno zdravili z rastnim hormonom (somatotropinom) ali z zdravili, ki vplivajo na izločanje rastnega hormona iz hipofize.
The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight. 
Priporočeni enkratni odmerek rekonstituirane suspenzije je 500 mikrogramov macimorelina na kg telesne mase.
• 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). 
• zdravila, ki lahko zavrejo odziv rastnega hormona na macimorelin (kot so muskarinski antagonisti: atropin, zdravila proti hipertiroidizmu: propiltiouracil in zdravila z rastnim hormonom).
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). 
• če ste alergični na macimorelin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin 
Prekinitev zdravljenja z rastnim hormonom (GH, growth hormone) ali zdravili, ki neposredno vplivajo na izločanje somatotropina iz hipofize
Therefore, the diagnostic performance of the test may by affected in patients with Cushing's disease or on supra-physiologic glucocorticoid therapy (e.g. systemic administration of doses of hydrocortisone (or its equivalent) in excess of 15 mg/m2/day) and lead to false positive test results. 
Zato je lahko pri bolnikih s Cushingovo boleznijo ali zdravljenjem s suprafiziološkimi odmerki glukokortikoidov (npr. sistemskim dajanjem odmerkov hidrokortizona (ali njegovega ekvivalenta) več kot 15 mg/m2/dan)
The suspension must be used within 30 minutes after preparation. 
Suspenzijo morate uporabiti v 30 minutah po pripravi.
In dose finding studies in healthy subjects, maximum stimulation of GH secretion was achieved following single dose administration of 0.5 mg/kg macimorelin. 
V študijah za ugotavljanje odmerka pri zdravih osebah je bila največja stimulacija izločanja rastnega hormona dosežena po dajanju enkratnega odmerka macimorelina 0,5 mg/kg.
• a bitter or metallic taste (dysgeusia) 
• grenak ali kovinski okus (disgevzija),
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). 
Učinki macimorelina na parametre EKG so bili raziskani v posebej zasnovani študiji QT pri supraterapevtskem odmerku macimorelina (2 mg/kg) in v študiji z enkratnimi odmerki, ki je obsegala tri naraščajoče ravni odmerke macimorelina (0,5 mg/kg, 1 mg/kg in 2 mg/kg).
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. 
Določite število vrečic zdravila Macimorelin Aeterna Zentaris, ki jih potrebujete glede na telesno maso bolnika: za bolnika, ki tehta do 120 kg, potrebujete eno vrečico, za bolnika, ki tehta več kot 120 kg, pa potrebujete dve vrečici.
The most common adverse reactions associated with Macimorelin Aeterna Zentaris reported in Study 052 (see section 5.1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%). 
Najpogostejši neželeni učinki, povezani z zdravilom Macimorelin Aeterna Zentaris, opisani v študiji 052 (glejte poglavje 5.1) pri 154 bolnikih so bili disgevzija (5 %), glavobol, utrujenost, navzea
Studies to detect macimorelin metabolites did not identify any metabolites. 
V študijah za odkrivanje presnovkov macimorelina niso odkrili nobenih presnovkov.
Contains lactose monohydrate 1,691.8 mg per sachet. 
Pomožne snovi z znanim učinkom Vsebuje 1.691,8 mg laktoze monohidrata na vrečico.