natgillin/translations-raw huggingface dataset:
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.
Macimorelin induced GH release was lower in patients with higher BMI. 
Pri bolnikih z višjo vrednostjo ITM je bilo z macimorelinom inducirano izločanje rastnega hormona manjše.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI PC: {številka}
Palpitations 
ZDRAVILA
Information about lactose and sodium 
Podatki o laktozi in natriju To zdravilo vsebuje laktozo.
Other medicines and Macimorelin Aeterna Zentaris Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris. 
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo
PK/PD relationship 
Farmakokinetično/farmakodinamično razmerje
Macimorelin Aeterna Zentaris contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
PHARMACEUTICAL FORM AND CONTENTS Granules for oral suspension in sachet 1 sachet (1,817 mg granules) 
1 vrečica (1.817 mg zrnc)
A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review. 
Odbor CHMP se je oktobra 2011 sestal z znanstveno svetovalno skupino (SAG) in upošteval njeno mnenje v okviru tega pregleda.
Aminocaproic acid 
Aminokaprojska kislina
The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007. 
Dovoljenja za promet z aprotininom so bila začasno umaknjena, ko so bili med prejšnjim pregledom leta 2007 predstavljeni dvomi o njegovi varnosti.
• The Committee considered that the product information should be updated. 
• odbor je presodil, da je treba posodobiti informacije o zdravilih.
The product information was modified to ensure that the information to healthcare professionals and patients is up to date. 
Informacije o zdravilih so bile spremenjene, da bi zdravstvenim delavcem in bolnikom zagotovili najnovejše informacije.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I). 
• odbor je upošteval postopek po členu 31 Direktive 2001/83/ES za aprotinin, aminokaprojsko kislino in traneksamično kislino (glejte Prilogo I);
The latest quality review of documents templates were taken into account during this review. 
Med tem pregledom je bil upoštevan zadnji pregled kakovosti predloge za dokumente.
Aminocaproic acid is a lysine analogue authorised for several indications since 1963. 
Aminokaprojska kislina je analog lizina in je že od leta 1963 odobrena za več indikacij.
These concerns echoed those of a few published observational studies. 
Ta odkritja so se ujemala z odkritji objavljenih opazovalnih študij.
EACA had not previously been associated with an increased risk of mortality and this has remained unchanged postpublication of the BART study. 
Aminokaprojske kisline prej niso povezovali s povečanim tveganjem za smrtnost in to se tudi po objavi študije BART ni spremenilo.
A list of indications for which the CHMP considered that the benefit risk balance remains positive is presented below. 
Seznam indikacij, za katere je CHMP menil, da zanje ostaja razmerje med tveganji in koristmi pozitivno, je na voljo spodaj.
Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes. 
Aprotinin - polipeptid, ki je naravno prisoten v telesu - je zaviralec proteolitičnih encimov.
Therefore the CHMP concluded that the balance of risks and benefits for aminocaproic acid is positive under normal conditions of use subject to the revision of the indications as follows: 
je odbor CHMP zaključil, da je razmerje med tveganji in koristmi za aminokaprojsko kislino pozitivno pri običajnih pogojih uporabe in z naslednjo revizijo indikacij:
It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein. 
Ima širok spekter delovanja na proteolitične encime, kot so plazmin, tripsin in kalikrein.
For some indications modifications to the wording were proposed, in order to bring them in line with current scientific knowledge on the use of EACA. 
Za nekatere indikacije so bile predlagane spremembe besedila, da bi jih uskladili s sedanjimi znanstvenimi dognanji o uporabi aminokaprojske kisline.
Data available from randomised clinical trials and observational studies, including meta-analysis were considered. 
Proučeni so bili razpoložljivi podatki iz randomiziranih kliničnih preskušanj in opazovalnih študij, vključno z metaanalizo.
The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin. 
Analoga lizina epsilon aminokaprojska kislina (EACA, imenuje se tudi aminokaprojska kislina) in traneksamična kislina (TXA) bolj specifično zavirata pretvorbo plazminogena v plazmin.
In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications. 
Marca 2010 je Nemčija sprožila napotitveni postopek po členu 31 za oceno razmerja med tveganji in koristmi pri uporabi antifibrinolitičnih zdravil aprotinina, aminokaprojske kisline in traneksamične kisline za vse odobrene indikacije.
The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines. 
Predhodni rezultati randomiziranega nadzorovanega kliničnega preskušanja, študije „Ohranjanje krvi z uporabo antifibrinolitikov: randomizirano preskušanje pri bolnikih po operaciji srca“ (BART), so pokazali, da so pri bolnikih, zdravljenih z aprotinininom, v 30-dnevnem obdobju opazili povečanje smrtnosti zaradi vseh vzrokov v primerjavi z bolniki, ki so jemali druga zdravila, čeprav je bila uporaba aprotinina povezana z manj resnimi krvavitvami kot katero koli od primerjalnih zdravil.
The results of the BART trial did not have a negative impact on the benefit risk profile of EACA. 
Rezultati preskušanja BART niso negativno vplivali na profil koristi in tveganj za aminokaprojsko kislino.
Leukopenia, thrombocytopenia, BUN (blood urea nitrogen) increased and renal failure are adverse events which can be serious and have been reported, but these risks had not been considered in the current authorised product information. 
Levkopenija, trombocitopenija, povišana raven sečninskega dušika v krvi in odpoved ledvic so neželeni učinki, ki so lahko resni in o katerih so poročali, toda ta tveganja niso bila upoštevana v podatkih o zdravilih, ki so trenutno odobrena.
Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss. 
Antifibrinolitiki (npr. aprotinin, aminokaprojska kislina in traneksamična kislina) so skupina hemostatikov, ki se uporabljajo za preprečevanje prekomerne izgube krvi.
The safety profile of EACA has evolved since its authorisation, and safety data has accumulated over the years. 
Po odobritvi aminokaprojske kisline se je varnostni profil te učinkovine še povečal in podatkov o varnosti je bilo skozi leta čedalje več.
Taking into account all the available information on safety and efficacy, the Committee agreed on the variation of the marketing authorisation with the balance of the risks and benefits considered positive in the following revised indications for EACA: 
Ob upoštevanju vseh razpoložljivih informacij o varnosti in učinkovitosti je Odbor pristal na spremembo dovoljenj za promet z zdravili, ker meni, da je razmerje med tveganji in koristmi pozitivno za naslednje revidirane indikacije za aminokaprojsko kislino:
Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA). 
Odbor CHMP je za tri antifibrinolitike (aprotinin, aminokaprojsko kislino in traneksamično kislino) izdal ločena mnenja in sklepe.