natgillin/translations-raw huggingface dataset:
In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point. 
V starostni skupini od 60 do 65 let omejeni razpoložljivi podatki ne kažejo potrebe po specifični mejni vrednosti za preiskavo.
The mechanism for the observed QTcF prolongation is unknown. 
Mehanizem opaženega podaljšanja intervala QTcF ni znan.
Store in the original package, in order to protect from light and moisture. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
Preclinical data from safety pharmacology, repeated dose toxicity and genotoxicity studies reveal no specific hazard for humans. 
Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06 
Farmakoterapevtska skupina: diagnostiki, testi za ugotavljanje hipofiznega delovanja, oznaka ATC: V04CD06
This is not a treatment for patients who do not have enough growth hormone. 
Ne uporablja se za zdravljenje bolnikov, ki nimajo dovolj rastnega hormona.
• Physical exercise - avoid strenuous physical activity 24 hours before the test. 
• Telesna vadba - 24 ur pred preiskavo se izogibajte naporni telesni dejavnosti.
There are no data available on animal (see section 5.3) or human male and female fertility. 
Ni podatkov iz poskusov na živalih (glejte poglavje 5.3) ali glede plodnosti pri moških in ženskah.
Tell your doctor if you are taking medicines that can alter your heart rhythm, such as: 
Obvestite zdravnika, če jemljete zdravila, ki lahko spremenijo srčni ritem, kot so:
The shelf life of a sachet is 4 years. 
Neodprta vrečica Rok uporabnosti vrečice je 4 leta.
Based on current understanding, this is unlikely to decrease the specificity of the test. 
Na podlagi trenutnega razumevanja je malo verjetno, da bi to zmanjšalo specifičnost testa.
Any suspension that remains must not be stored and must be discarded. 
Dela suspenzije, ki ostane, ne smete shraniti,
Only limited pharmacokinetic data are available in the elderly. 
Pri starejših bolnikih je na voljo malo farmakokinetičnih podatkov.
All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes. 
Vse tri ravni odmerka so pokazale podobno podaljšanje intervala QTcF v temeljiti študiji QT, kar kaže na odsotnost sprememb, odvisnih od odmerka.
Potential for false negative test results in recent onset hypothalamic disease 
Možnost lažno pozitivnih rezultatov testa pri nedavnem pojavu hipotalamične bolezni
No specific recommendations after overdose are given. 
Posebnih priporočil za primer prevelikega odmerjanja ni.
No studies to assess carcinogenicity and effects on reproduction and development have been conducted. 
Študije za oceno kancerogenega potenciala ter vpliva na sposobnost razmnoževanja in razvoja niso bile izvedene.
• any other medicines that can prolong the QT interval or inducing torsades de pointes 
• katera koli druga zdravila, ki lahko podaljšajo interval QT ali povzročijo torsades de pointes.
SPECIAL STORAGE CONDITIONS Reconstituted suspension: 
POSEBNA NAVODILA ZA SHRANJEVANJE Rekonstituirana suspenzija:
Each cardboard box contains 1 sachet. 
Ena kartonska škatla vsebuje 1 vrečico.
• The active substance is macimorelin. 
• Učinkovina je macimorelin.
Growth hormone secretion normally decreases with age. 
Izločanje rastnega hormona se običajno zmanjšuje s starostjo.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should take this medicinal product only if the expected benefit of the test clearly outweighs the potential risk associated with an intake of maximum 1,691.8 mg lactose per sachet. 
Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze-galaktoze lahko uporabijo to zdravilo samo, če pričakovana korist preiskave jasno odtehta morebitno tveganje, povezano z vnosom do 1.691,8 mg laktoze na vrečico.
Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours. 
Macimorelin se izloča s povprečno končno razpolovno dobo (T1/2) 4,1 ure.
A decision must be made whether to discontinue breast-feeding or to abstain from macimorelin, taking into account the benefit of breast-feeding for the child and the benefit of the test for the woman. 
Odločiti se je treba med prenehanjem dojenja ali opustitvijo uporabe macimorelina, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti preiskave za mater.
These side effects are mostly mild, do not last long, and usually go away quickly without treatment. 
Ti neželeni učinki so večinoma blagi in kratkotrajni ter običajno hitro izzvenijo brez zdravljenja.
Four groups of individuals were evaluated: three groups of adult patients with different pre-test probability of growth hormone deficiency (Group A (high likelihood), Group B (intermediate likelihood), Group C (low likelihood) and healthy control subjects (Group D)). 
Ovrednotili so štiri skupine preiskovancev: tri skupine odraslih bolnikov z različnimi verjetnostmi pomanjkanja rastnega hormona pred testiranjem (skupina A (velika verjetnost), skupina B (vmesna verjetnost), skupina C (majhna verjetnost) in zdrave kontrolne preiskovance (skupina D)).
The suspension should be stirred until it is slightly turbid without particles at the bottom of the container. 
Suspenzijo morate mešati, dokler ni rahlo motna, na dnu pa ni delcev.
You have to drink the complete test dose within 30 seconds. 
Celotni odmerek za preiskavo morate spiti v 30 sekundah.
Prepare plasma or serum samples and send to a laboratory for growth hormone determination. 
Vzorce plazme ali seruma pripravite in jih pošljite v laboratorij za določanje rastnega hormona.
The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2. 
Varnost in diagnostična uspešnost macimorelina nista bili dokazani pri bolnikih z ITM > 40 kg/m2.
Measure the required volume using a 50 mL graduated syringe without a needle. 
Izmerite zahtevani volumen s 50-ml graduirano brizgo brez igle.
The description in this leaflet is for your information on the testing procedure. 
Opis v tem navodilu je namenjen vam, da se seznanite s potekom preiskave.
Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM. 
Vezava na beljakovine v plazmi upada pri višjih koncentracijah, pri čemer je 78-odstotna pri 0,1 μM in 62-odstotna pri 10 μM.
The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years. 
Farmakodinamika macimorelina ni bila dovolj ovrednotena pri osebah, starih > 65 let.
As with all GH stimulation tests, also the macimorelin test results should always be interpreted on basis of the outcome of all examinations within the diagnostic work-up for a patient. 
Kot pri vseh preiskavah stimulacije rastnega hormona moramo rezultate preiskave z macimorelinom vedno razlagati z upoštevanjem rezultatov vseh preiskav v okviru diagnostične obravnave bolnika.
This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vrečico, kar pomeni, da je v bistvu „brez natrija“.
No drug-drug interaction studies have been performed in humans. 
Študij medsebojnega delovanja med zdravili pri ljudeh niso izvedli.
One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin. 
Od 157 preiskovancev, ki so v tej študiji opravili vsaj eno od preiskav, je bilo 59 % moških, 41 % žensk in 86 % belcev.
It is a test that helps your doctor to diagnose this condition. 
Uporablja se za preiskavo, ki zdravniku pomaga diagnosticirati omenjeno bolezen.
There are no data for the use of macimorelin in pregnant women. 
Podatkov o uporabi macimorelina pri nosečnicah ni.
Any remaining suspension must be discarded by your doctor or nurse according to local regulations. 
Morebitni ostanek suspenzije mora zdravnik ali medicinska sestra zavreči v skladu z lokalnimi predpisi.
If either of these conditions is not met, the growth hormone stimulation test must be re-scheduled for a new test day. 
Če kateri koli od teh pogojev ni izpolnjen, je treba preiskavo stimulacije rastnega hormona odložiti.
Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended. 
Priporočljivo je dovolj dolgo obdobje izpiranja (pet razpolovnih dob izločanja) zdravil pred dajanjem macimorelina.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before this medicine is given to you. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• Fasting - you must not eat for at least 8 hours before the test, and during the test. 
• Teščost - vsaj 8 ur pred preiskavo in med njo ne smete jesti.
Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need. 
Na splošno so poročali o neželenih učinkih, ki so bili večinoma blagi in kratkotrajni brez posebne potrebe po zdravljenju.
One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box. 
Ena vrečica iz LDPE/Al/LDPE/papirja, ki vsebuje 1.817 mg zrnc, pakirana v kartonski škatli.
Add required volume of water in a graduated glass or transparent plastic container. 
Nalijte zahtevano količino vode v graduirano stekleno ali prozorno plastično posodo.
To ensure that the test results are reliable, you need to follow the rules below: 
Upoštevajte naslednja pravila, da zagotovite zanesljive rezultate preiskave:
During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions. 
Med kliničnim razvojem so pri enem preiskovancu opazili dve prehodni nepravilnosti na EKG in ju poročali kot resna morebitna neželena učinka.
If you are breast-feeding or intend to breast-feed, a risk to the suckling child cannot be excluded. 
Če dojite ali nameravate dojiti, tveganja za dojenega otroka ni mogoče izključiti.
• cystic fibrosis (lumacaftor) 
• cistične fibroze (lumakaftor);
Paediatric population The safety and efficacy of macimorelin in children and adolescents below 18 years have not yet been established (see also section 5.2). 
Pediatrična populacija Varnost in učinkovitost macimorelina pri otrocih ter mladostnikih, starih do 18 let, še nista bili dokazani (glejte poglavje 5.2).
No studies have been conducted to evaluate the pharmacokinetics of macimorelin in paediatric patients or in patients with renal or hepatic impairment. 
Študije za oceno farmakokinetike macimorelina pri pediatričnih bolnikih ali pri bolnikih z okvaro ledvic ali jeter niso bile izvedene.
Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels. 
Rekonstituirano suspenzijo damo peroralno bolnikom, ki so vsaj 8 ur tešči in ki niso izvajali napornih telesnih vaj 24 ur pred preiskavo, saj lahko oboje vpliva na raven rastnega hormona.
DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Women of childbearing potential must use adequate contraceptive methods at the time when macimorelin will be administered. 
Ženske v rodni dobi morajo v času dajanja macimorelina uporabljati ustrezne kontracepcijske metode.
In such a situation, a repetition of the test may be required. 
V takšnem primeru bo morda treba preiskavo ponoviti.
Growth hormone medicinal products should be discontinued at least 1 month before administering macimorelin. 
Uporabo zdravil z rastnim hormonom moramo prekiniti vsaj 1 mesec pred dajanjem macimorelina.
Macimorelin Aeterna Zentaris can cause changes in the ECG (electrocardiogram) including QT prolongation that are associated with an increased risk for arrhythmias. 
Zdravilo Macimorelin Aeterna Zentaris lahko povzroči spremembe na EKG (elektrokardiogramu), vključno s podaljšanjem intervala QT, kar je povezano s povečanim tveganjem za aritmije.
It is unknown whether macimorelin or its metabolites are excreted in human milk. 
Ni znano, ali se macimorelin ali njegovi presnovki izločajo v materino mleko.
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. 
Oba opazovana dogodka, kot sta bila predhodno določena v študiji 052 (spodnja meja 95-odstotnega IZ za negativno ujemanje ≥ 75 %, spodnja meja 95-odstotnega IZ za pozitivno ujemanje ≥ 70 %), sta izpolnjena, če uporabljamo mejno točko za ITT pri 3,0 ng/ml in vnaprej določeno mejno točko za
The dose is calculated based on the patient´s body weight. 
Odmerek je odvisen od bolnikove telesne mase.
The oral bioavailability may be limited (among others) by first pass metabolism via CYP3A4 (see section 4.5). 
Peroralna biološka uporabnost je lahko omejena (med drugim) s presnovo prvega prehoda prek CYP3A4 (glejte poglavje 4.5).
A healthcare professional must supervise the preparation and use of Macimorelin Aeterna Zentaris. 
Zdravstveni delavec mora nadzorovati pripravo in uporabo zdravila Macimorelin Aeterna Zentaris.
GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK). 
Ravni rastnega hormona so bile izmerjene v osrednji ustanovi s testom IDS-iSYS (Immunodiagnostic Systems Ltd., Velika Britanija).
• 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. 
• Če ste se nedavno zdravili zaradi Cushingove bolezni (motnje, ki povzroča visoko raven hormona kortizola) ali če prejemate velik odmerek zdravila, imenovanega hidrokortizon, saj lahko test da lažno pozitivne rezultate.
Macimorelin Aeterna Zentaris granules are to be reconstituted with water and must be used within 30 minutes after preparation. 
Zdravilo Macimorelin Aeterna Zentaris rekonstituiramo z vodo in ga uporabimo v 30 minutah po pripravi.
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). 
Zato je lahko indicirana kontrola z EKG pred dajanjem macimorelina ter 1 uro, 2 uri, 4 ure in 6 ur po dajanju macimorelina (glejte tudi poglavje 4.4).
Further possible undesirable effects in case of overdosing could include headache, nausea, vomiting and diarrhoea. 
Dodatni morebitni neželeni učinki v primeru prevelikega odmerjanja lahko vključujejo glavobol, navzeo, bruhanje in drisko.
Based on current understanding, this potential is unlikely to decrease the specificity of the test. 
Na podlagi trenutnega razumevanja to tveganje verjetno ne zmanjša specifičnosti preiskave.
• infections (antibiotics such as rifabutin, rifampicin) 
• okužb (antibiotiki, kot sta rifabutin, rifampicin);
Macimorelin was absorbed rapidly and the maximum plasma macimorelin concentrations (Cmax) were observed approximately 30 minutes to 1 hour and 10 minutes after oral administration of 0.5 mg/kg macimorelin after fasting for at least 8 hours. 
Macimorelin se je hitro absorbiral in največje koncentracije macimorelina (Cmax) v plazmi so ugotovili približno od 30 minut do 1 ure in 10 minut po peroralnem dajanju macimorelina v odmerku 0,5 mg/kg osebam, ki so bile tešče vsaj 8 ur.
The number of test sachets needed is based on body weight. 
Število potrebnih vrečic zdravila je odvisno od telesne mase.
Agreement between the result of the first test and the second test was observed in 31 cases (91.2%). 
Ponovljivost je bila preverjena v podskupini 34 preiskovancev, za katere so izvedli dva testa MAC. Ujemanje med rezultatom prvega in drugega testa je bilo ugotovljeno v 31 primerih (91,2 %).
QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. 
Podaljšanje intervala QT lahko privede do razvoja ventrikularne tahikardije vrste torsades de pointes, pri čemer se tveganje z naraščanjem podaljšanja intervala QT povečuje.
• cancer (dabrafenib, enzalutamide) 
• raka (dabrafenib, enzalutamid).
Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg. 
Določite količino suspenzije, ki jo potrebujete za priporočeni odmerek macimorelina 0,5 mg/kg.
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 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.
• type 2 diabetes (pioglitazone) 
• sladkorne bolezni tipa 2 (pioglitazon);
In case you should have heart rhythm disturbances, an ECG monitoring will be performed. 
Če imate motnje srčnega ritma, vas bo spremljali z
Tell your doctor if you are taking medicines that could increase the breakdown of macimorelin such as specific medicines to treat: 
Obvestite zdravnika, če jemljete zdravila, ki bi lahko povečala razkroj macimorelina, kot so določena zdravila za zdravljenje:
If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded. 
Če se macimorelin daje bolnikom z okvaro ledvic in/ali jeter, ni mogoče izključiti možnosti za zvišano raven macimorelina v plazmi.
The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2). 
Varnosti in učinkovitosti macimorelina pri bolnikih z okvaro ledvic in/ali jeter niso dokazali (glejte tudi poglavje 5.2).
In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1). 
QTc > 500 ms moramo spremljati EKG (glejte poglavji 4.4 in 5.1).
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. 
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.
• mild to moderate depressive episodes (St. John´s wort (Hypericum perforatum)) 
• blagih do zmernih depresivnih epizod (šentjanževka (Hypericum perforatum));
Talk to your doctor or nurse if: 
Z zdravnikom ali medicinsko sestro se posvetujte v naslednjih primerih:
Macimorelin is not recommended during pregnancy. 
Macimorelin v nosečnosti ni priporočljiv.
Other hormone deficiencies if untreated could lead to inaccurate results in the growth hormone stimulation test. 
Druga nezdravljena pomanjkanja hormonov lahko privedejo do nenatančnih rezultatov pri testu s stimulacijo rastnega hormona.
Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1). 
Zdravilo Macimorelin Aeterna Zentaris je indicirano za diagnosticiranje pomanjkanja rastnega hormona (GHD, growth hormone deficiency) pri odraslih (glejte poglavje 5.1).
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. 
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.
Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream. 
Macimorelin deluje kot naravni hormon in povzroča, da hipofiza izloča rastni hormon v krvni obtok.
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). 
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).
1 mL of the reconstituted suspension contains 500 micrograms macimorelin. 
1 ml rekonstituirane suspenzije vsebuje 500 mikrogramov macimorelina.
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. 
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.
The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation. 
Mejna vrednost za preiskavo z macimorelinom v prehodnem obdobju od pozne pubertete do odraslosti ni bila ugotovljena.
The use of Macimorelin Aeterna Zentaris must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency. 
Uporabo zdravila Macimorelin Aeterna Zentaris mora nadzorovati zdravnik ali zdravstveni delavec, ki ima izkušnje z diagnosticiranjem pomanjkanja rastnega hormona.
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. 
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,
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). 
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).