natgillin/translations-raw huggingface dataset:
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.
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 klinično pomembni koncentraciji 0,1 μM (klinična vrednost Cmax = 11,2 ng/ml = pribl.
Co-administration of a CYP3A4 inhibitor may increase the macimorelin plasma concentration, and this, in turn, could yield higher plasma GH levels.
Sočasno dajanje zaviralca CYP3A4 lahko zviša koncentracijo macimorelina v plazmi in posledično zviša plazemske ravni rastnega hormona.
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.
Ocena teščosti in odsotnosti predhodne naporne telesne vadbe Pred uporabo zdravila Macimorelin Aeterna Zentaris se morate prepričati, da je bolnik tešč vsaj 8 ur in da 24 ur pred preiskavo ni izvajal napornih telesnih vaj, saj lahko oboje vpliva na ravni rastnega hormona.
• thirst
• žeja,
The suspension must be prepared and administered by a healthcare professional.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Suspenzijo mora pripraviti in dati zdravstveni delavec.
A dose of 0.5 mg/kg macimorelin was shown to induce maximal GH release.
Dokazali so, da je odmerek 0,5 mg/kg macimorelina povzročil največje izločanje rastnega hormona.
• that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
• zmanjšala odziv rastnega hormona na macimorelin, kot so: atropin, propiltiouracil, zdravila z rastnim hormonom.
38 (27%) in Group A, 37 (26%) in Group B, 40 (29%) in Group C and 25 (18%) in Group D. One out of 154 MAC tests (0.6%) performed failed due to a technical error and 27 out of 157 ITTs (17.2%) performed failed because induction of severe hypoglycemia (i.e., the stimulus) could not be achieved.
testov MAC (0,6 %) ni uspel zaradi tehnične napake in 27 od 157 testov ITT (17,2 %) ni uspelo, ker ni bilo mogoče doseči indukcije hude hipoglikemije (tj. dražljaja).
• that could increase growth hormone levels: such as clonidine, levodopa, insulin
• zvišala ravni rastnega hormona, kot so: klonidin, levodopa, insulin;
Frequency not known (cannot be estimated from the available data):
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): • spremembe v elektrokardiogramu (EKG).
For both the ITT and the MAC test, serum concentrations of GH were measured at 30, 45, 60 and 90 minutes after administration.
Tako pri testu ITT kot MAC so bile koncentracije rastnega hormona v serumu izmerjene 30, 45, 60 in
Potentially re-test needed in early disease
V zgodnjem obdobju bolezni je morda potrebna ponovitev preiskave.
Macimorelin Aeterna Zentaris has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Macimorelin Aeterna Zentaris ima blag vpliv na sposobnost vožnje in upravljanja strojev.
DIRECTIONS FOR PREPARATION AND USE
OZNAČEVANJE IN NAVODILO ZA UPORABO
Marketing Authorisation Holder and Manufacturer Aeterna Zentaris GmbH
Imetnik dovoljenja za promet z zdravilom in izdelovalec Aeterna Zentaris GmbH
Tell your doctor if you are taking medicines that may impact the accuracy of the diagnostic test. Avoid concomitant use with medicines:
Obvestite zdravnika, če jemljete zdravila, ki lahko vplivajo na natančnost diagnostične preiskave.
• feeling hot
• občutek vročine.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aeterna Zentaris GmbH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Aeterna Zentaris GmbH
• lower than normal heart rate (sinus bradycardia)
• občutek razbijanja srca (palpitacije), • srčni utrip, ki je počasnejši od normalnega (sinusna bradikardija),
You may not perform strenuous physical exercises 24 hours before the test. You can drink up to 100 mL of still water within 1 hour before and within 1 hour after intake of Macimorelin Aeterna Zentaris.
Spijete lahko največ 100 ml negazirane vode v 1 uri pred preiskavo in v 1 uri po prejemu zdravila Macimorelin Aeterna Zentaris.
• The other ingredients are: lactose monohydrate (see section 2 under ‘Macimorelin Aeterna Zentaris contains lactose'), colloidal anhydrous silica,
• Druge sestavine zdravila so: laktoza monohidrat (glejte poglavje 2, razdelek „Zdravilo Macimorelin Aeterna Zentaris vsebuje laktozo“), brezvodni koloidni silicijev dioksid, krospovidon tipa A, natrijev saharinat dihidrat in natrijev stearilfumarat (glejte poglavje 2, razdelek „Zdravilo Macimorelin Aeterna Zentaris vsebuje natrij“).
What you need to know before Macimorelin Aeterna Zentaris is given 3.
Kaj morate vedeti, preden boste uporabili zdravilo Macimorelin Aeterna Zentaris 3.
An exploratory analysis was conducted on the performance of the MAC based on an ITT cut-off point of 3.0 ng/mL.
Post-hoc analiza z mejno točko 3,0 ng/ml za test ITT Izvedena je bila raziskovalna analiza o natančnosti testa MAC z mejno točko ITT 3,0 ng/ml.
MedDRA organ class
Organski sistem MedDRA
Determine the number of test 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, 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.
Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin.
Macimorelin je peroralni peptidomimetik z aktivnostjo spodbujanja izločanja rastnega hormona (GH), podobno kot grelin.
Renal and/or hepatic impairment
Okvara ledvic in/ali jeter
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
You will have three blood samples taken to measure growth hormone, one sample each at 45, 60 and 90 minutes after taking the test dose.
Za meritev ravni rastnega hormona vam bodo odvzeli tri vzorce krvi, in sicer po en vzorec 45, 60 in 90 minut po prejemu odmerku zdravila.
PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Zrnca za peroralno suspenzijo v vrečici.
Step 1 Weigh the patient.
Bolnika stehtajte.
Medicinal products with a potential to induce torsades de pointes
Zdravila, ki lahko inducirajo tahikardijo torsades de pointes
• sleep disorder (modafinil, pitolisant)
• motnje spanja (modafinil, pitolizant);
The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.
Izločanje rastnega hormona moramo ovrednotiti s tremi vzorci krvi, odvzetimi 45, 60 in 90 minut po dajanju zdravila.
Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Vzorce venske krvi za določanje rastnega hormona odvzemite 45, 60 in 90 minut po dajanju zdravila.
• medicines to treat infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
• zdravila za zdravljenje psihoz (kot so klorpromazin, haloperidol); • zdravila za zdravljenje okužb (antibiotiki, kot so eritromicin, klaritromicin, moksifloksacin);
Positive agreement is the proportion of subjects with a positive ITT (i.e., those who have GHD per the ITT) who also have a positive macimorelin test. With a high level of positive agreement, the MAC test will not wrongly diagnose an individual with GHD per the ITT as not having GHD.
Pozitivno ujemanje je delež preiskovancev, ki so imeli pozitiven test ITT (tj. tistih, ki imajo pomanjkanje rastnega hormona s testom ITT) in hkrati pozitiven test z macimorelinom.
One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Za bolnika z ≤ 120 kg potrebujemo eno vrečico, za bolnika s telesno maso nad 120 kg pa potrebujemo dve vrečici.
Macimorelin Aeterna Zentaris must not be used in children and adolescents aged below 18 years, because the safety and effectiveness in these groups have not yet been established.
18 let, ker varnost in učinkovitost pri teh skupinah še nista bili dokazani.
• that could have a direct influence on growth hormone secretion by the pituitary gland: such as somatostatin, insulin, glucocorticoids, acetylsalicylic acid,
• imela neposreden vpliv na izločanje rastnega hormona v hipofizi, kot so: somatostatin, insulin,
How Macimorelin Aeterna Zentaris is stored 6.
Shranjevanje zdravila Macimorelin Aeterna Zentaris 6.
Potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors
Možnost povečane peroralne biološke uporabnosti in koncentracije macimorelina v plazmi pri uporabi močnih zaviralcev CYP3A4/P-gp Študij medsebojnega delovanja z zaviralci CYP3A4/P-gp niso izvedli.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Razlaga rezultatov preiskave z macimorelinom
The efficacy of macimorelin in patients aged over 65 years has not been established.
Učinkovitost macimorelina pri bolnikih,
How Macimorelin Aeterna Zentaris is given
Kako se daje zdravilo Macimorelin Aeterna Zentaris
Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy
Bolniki s Cushingovo boleznijo ali zdravljenjem s suprafiziološkimi odmerki glukokortikoidov Hiperkortizolizem pomembno vpliva na os hipotalamus-hipofiza-nadledvična žleza.
Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
Prekinitev zdravljenja z rastnim hormonom (GH) ali zdravili, ki neposredno vplivajo na izločanje somatotropina v hipofizi Bolnikom na nadomestnem zdravljenju z rastnim hormonom (GH, somatotropinom) ali zdravili, ki neposredno vplivajo na izločanje somatotropina v hipofizi (npr. analogi somatostatina, klonidin,
ECG T wave abnormal
sinusna bradikardija nenormalen val T na EKG
What you need to know before Macimorelin Aeterna Zentaris is given
Kaj morate vedeti, preden boste uporabili zdravilo Macimorelin Aeterna Zentaris Zdravila Macimorelin Aeterna Zentaris ne smete prejeti,
What Macimorelin Aeterna Zentaris contains
Zdravilo Macimorelin Aeterna Zentaris vsebuje natrij
If any of the above applies to you, or if you are not sure, talk to your doctor or nurse before you are given this medicine.
Če kar koli od zgoraj naštetega velja za vas (ali ste glede naštetega negotovi), se pred prejemom tega zdravila posvetujte z zdravnikom ali medicinsko sestro.
Fatigue Feeling hot
Splošne težave in spremembe na mestu aplikacije utrujenost občutek vročine občutek mraza lakota žeja
These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
in podaljšanje intervala QT (glejte tudi poglavje 4.4).
Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Macimorelin Aeterna Zentaris 60 mg zrnca za peroralno suspenzijo v vrečici macimorelin
You must be fasting for at least 8 hours before you are given Macimorelin Aeterna Zentaris.
Preden prejmete zdravilo Macimorelin Aeterna Zentaris, morate biti tešči vsaj 8 ur.
• Medicinal products that directly affect the pituitary secretion of growth hormone (such as somatostatin, insulin, glucocorticoids, and cyclooxygenase inhibitors such as acetylsalicylic acid or indometacin).
insulin, glukokortikoidi in zaviralci ciklooksigenaze, kot sta acetilsalicilna kislina ali indometacin);
Macimorelin is metabolised mainly by CYP3A4 in vitro.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Macimorelin se in vitro presnavlja predvsem s CYP3A4.
Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Podatki o varnosti in učinkih macimorelina pri dolgotrajni uporabi niso na voljo.
NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension macimorelin
Macimorelin Aeterna Zentaris 60 mg zrnca za peroralno suspenzijo macimorelin
The suspension must be administered within 30 minutes after preparation.
Rekonstituirana suspenzija Suspenzijo morate zaužiti v 30 minutah po pripravi.
Negative agreement is the proportion of subjects with a negative ITT (i.e., those who do not have GHD per the ITT) who also have a negative MAC test. With a high level of negative agreement, the MAC test will not wrongly diagnose an individual without GHD per the ITT as having GHD.
Visoka stopnja negativnega ujemanja pomeni, da test MAC ne bo napačno opredelil osebe, ki nima pomanjkanja rastnega hormona s testom ITT, kot bolnika s pomanjkanjem rastnega hormona.
Driving and using machines Dizziness can occur with Macimorelin Aeterna Zentaris.
Pri uporabi zdravila Macimorelin Aeterna Zentaris se lahko pojavi omotičnost.
• feeling cold
• občutek mraza, • lakota,
Macimorelin Aeterna Zentaris is presented as white to off-white granules for oral suspension.
Izgled zdravila Macimorelin Aeterna Zentaris in vsebina pakiranja Zdravila Macimorelin Aeterna Zentaris so bela ali skoraj bela zrnca za peroralno suspenzijo.
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILA ZA PRIPRAVO IN UPORABO Suspenzijo mora pripraviti in dati zdravstveni delavec.
Macimorelin Aeterna Zentaris is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Zdravilo Macimorelin Aeterna Zentaris je indicirano za diagnostično preiskavo z enim odmerkom.
• 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.
• Če vam v telesu manjka kakšen drug hormon, npr. kortizol, ščitnični hormoni ali spolni hormoni,
Abdominal pain
PODATKI NA PRIMARNI OVOJNINI
NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Macimorelin Aeterna Zentaris 60 mg zrnca za peroralno suspenzijo v vrečici
Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin.
Bolnikom na nadomestnem zdravljenju z rastnim hormonom (GH, somatotropinom) ali zdravili, ki neposredno vplivajo na izločanje somatotropina v hipofizi (npr. analogi somatostatina, klonidin,
Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi laktoza monohidrat koloidni brezvodni silicijev dioksid krospovidon tipa A natrijev saharinat dihidrat natrijev stearilfumarat 6.2 Inkompatibilnosti Navedba smiselno ni potrebna.