FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Macimorelins indvirkning på EKG-parametre blev vurderet i et dedikeret, grundigt QT-studie, der i en 3-vejs-overkrydsningsundersøgelse af 60 raske forsøgspersoner så nærmere på effekten af en supraterapeutisk dosis macimorelin (2 mg/kg, dvs. 4 gange den anbefalede dosis) sammenholdt med placebo og moxifloxacin.
English: Instructions are given at the end of this leaflet on how to prepare the test.
Danish: Bagerst i denne indlægsseddel er der en vejledning i klargøring af testen.
English: Other medicines and Macimorelin Aeterna Zentaris Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Macimorelin Aeterna Zentaris Fortæl det til lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: The number of test sachets needed is based on body weight.
Danish: Antallet af breve, der skal bruges til en test, afhænger af patientens legemsvægt.
English: 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).
Danish: Samtidig administration af macimorelin og lægemidler, der har potentiale til at inducere torsades de pointes (antipsykotiske lægemidler som f.eks. chlorpromazin, haloperidol, antibiotika (f.eks. moxifloxacin, erythromycin, clarithromycin), antiarytmika af klasse Ia (f.eks. quinidin) og klasse III (f.eks. amiodaron, procainamid, sotalol), eller andre lægemidler, der kan inducere torsades de pointes), bør undgås (se pkt.
English: Potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors
Danish: Potentiale for øget oral biotilgængelighed og plasmakoncentration af macimorelin ved brug af stærke CYP3A4/P-gp-hæmmere
English: • lower than normal heart rate (sinus bradycardia)
Danish: • hjerterytme, der er langsommere end normalt (sinusbradykardi)
English: • Medicinal products that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin).
Danish: • Lægemidler, der midlertidigt kan øge koncentrationen af væksthormon (f.eks. clonidin, levodopa og insulin).
English: The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
Danish: Den anbefalede enkeltdosis af den rekonstituerede suspension er 500 mikrogram macimorelin pr. kg legemsvægt.
English: Any unused medicine or waste material should be disposed in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: 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).
Danish: Macimorelins indvirkning på EKG-parametre blev undersøgt i et dedikeret, grundigt QT-studie af en supraterapeutisk dosis macimorelin (2 mg/kg) og i et studie med stigende enkeltdosis, der omfattede tre dosisniveauer af macimorelin (0,5 mg/kg, 1 mg/kg og 2 mg/kg).
English: D-60314 Frankfurt am Main Germany
Danish: D-60314 Frankfurt am Main Tyskland
English: The suspension must be administered within 30 minutes after preparation.
Danish: Suspensionen skal administreres inden for 30 minutter efter klargøring.
English: ECG QT prolonged
Danish: Forlænget QT på EKG
English: • 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).
Danish: • Lægemidler, der kan sløve væksthormonresponset over for macimorelin (f.eks. muskarin antagonister (atropin), antithyroide lægemidler (propylthiouracil og væksthormonmidler)).
English: 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.
Danish: Vurdering af fastende tilstand og undladelse af forudgående anstrengende fysisk aktivitet Inden anvendelse af Macimorelin Aeterna Zentaris er det vigtigt at sikre sig, at patienten har fastet i mindst 8 timer og ikke har udført anstrengende fysisk aktivitet inden for 24 timer inden testen, da både mad og fysisk aktivitet kan have indvirkning på niveauet af væksthormon.
English: Aeterna Zentaris GmbH Weismuellerstrasse 50 60314 Frankfurt am Main Germany
Danish: Aeterna Zentaris GmbH Weismuellerstrasse 50 60314 Frankfurt am Main Tyskland
English: Fluid intake of no more than 100 mL of non-carbonated water is allowed each within 1 hour pre-dose, as well as within 1 hour post-dose (see section 4.4).
Danish: Indtag af højst 100 ml vand (uden kulsyre) er tilladt inden for 1 time inden administration samt inden for 1 time efter administration (se pkt.
English: The suspension must be taken within 30 minutes after preparation.
Danish: Suspensionen skal tages inden for 30 minutter efter klargøring.
English: • that could increase growth hormone levels: such as clonidine, levodopa, insulin
Danish: • der kan øge væksthormon-niveauet (f.eks. clonidin, levodopa, insulin)
English: The suspension must be used within 30 minutes after preparation.
Danish: Suspensionen skal anvendes inden for 30 minutter efter klargøring.
English: D-60314 Frankfurt am Main, Germany
Danish: D-60314 Frankfurt am Main, Tyskland
English: • 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).
Danish: • Lægemidler med direkte indvirkning på hypofysens udskillelse af væksthormon (f.eks. somatostatin, insulin, glukokortikoider og cyclooxygenase-hæmmere, herunder acetylsalicylsyre og indometacin).
English: Sinus bradycardia
Danish: Sinusbradykardi
English: Aeterna Zentaris GmbH Weismüllerstrasse 50 D-60314 Frankfurt am Main Germany
Danish: Aeterna Zentaris GmbH Weismüllerstrasse 50 D-60314 Frankfurt am Main Tyskland
English: 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.
Danish: Frigivelsen af væksthormon skal vurderes i tre blodprøver, der tages hhv. 45, 60 og 90 minutter efter administration af lægemidlet.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
Danish: Disse EKG-forandringer omfattede T-tak-anomalier og QT-forlængelse.
English: These ECG abnormalities consisted of T wave abnormalities and QT prolongation (see also section 4.4).
Danish: Disse EKG-forandringer omfattede T-tak-anomalier og QT-forlængelse (se også pkt.
English: 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.
Danish: Bestem, hvor mange Macimorelin Aeterna Zentaris breve der skal bruges, ud fra legemsvægten: Der skal bruges ét brev til en patient, der vejer op til 120 kg, og to breve til en patient, der vejer mere end 120 kg.
English: Macimorelin Aeterna Zentaris is presented as white to off-white granules for oral suspension.
Danish: Macimorelin Aeterna Zentaris fås som et hvidt til råhvidt granulat til oral suspension.
English: Exogenous GH or medicinal products directly affecting the pituitary gland could influence the somatotropic function of the pituitary gland and lead to unreliable GH stimulation results (see also section 4.2 and section 4.5).
Danish: Eksogent væksthormon eller lægemidler med direkte indvirkning på hypofysen kan påvirke hypofysens somatotropinfunktion og medføre upålidelige resultater for væksthormonstimulationen (se også pkt.
English: Fatigue Feeling hot
Danish: Træthed Varmefølelse
English: 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.
Danish: Patienter i erstatningsterapi med væksthormon (somatotropin) eller i behandling med lægemidler med direkte indvirkning på hypofysens udskillelse af somatotropin (f.eks. somatostatin-analoger, clonidin, levodopa og dopaminagonister) skal have besked på at stoppe en sådan behandling mindst 1 måned, før de får macimorelin.
English: 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.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med lægen eller sundhedspersonalet, før du får dette lægemiddel.
English: A sufficient washout time of five elimination half-lives of the CYP3A4 inducer prior to administration of the test is recommended (see section 4.2 and section 4.4).
Danish: En tilstrækkelig udvaskningsperiode på fem eliminationshalveringstider for CYP3A4-induceren inden administration af macimorelin anbefales (se pkt.
English: • medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
Danish: • lægemidler til korrektion af hjerterytmen (antiarytmika som f.eks. amiodaron, procainamid,
English: Any remaining suspension must be discarded by your doctor or nurse according to local regulations.
Danish: Ubrugt suspension skal bortskaffes af lægen eller sundhedspersonalet i henhold til lokaleretningslinjer.
English: There are no data available on animal (see section 5.3) or human male and female fertility.
Danish: Der foreligger ingen data om fertiliteten hos dyr (se pkt.
English: These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5).
Danish: Disse stoffer kan medføre upålidelige resultater for væksthormonstimulationen (se også pkt.
English: Women of childbearing potential
Danish: Kvinder, der kan blive gravide
English: Driving and using machines Dizziness can occur with Macimorelin Aeterna Zentaris.
Danish: Svimmelhed kan forekomme ved anvendelse af Macimorelin Aeterna Zentaris.
English: Contains lactose monohydrate 1,691.8 mg per sachet.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Indeholder 1.691,8 mg lactosemonohydrat pr. brev.
English: If you are given more Macimorelin Aeterna Zentaris than you should, tell your doctor or nurse.
Danish: Hvis du har fået for meget Macimorelin Aeterna Zentaris Hvis du har fået for meget Macimorelin Aeterna Zentaris, skal du fortælle det til lægen eller sundhedspersonalet.
English: Tell your doctor if you are taking medicines that may impact the accuracy of the diagnostic test. Avoid concomitant use with medicines:
Danish: Fortæl det til lægen, hvis du tager medicin, der kan påvirke nøjagtigheden af den diagnostiske test.
English: Macimorelin showed a dose-dependent release of GH after oral dosing.
Danish: Macimorelin medførte en dosisafhængig frigivelse af væksthormon efter oral indgift.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 60 mg macimorelin (as acetate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 60 mg macimorelin (som acetat).
English: • that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
Danish: • der kan mindske væksthormonresponset på macimorelin (f.eks. atropin, propylthiouracil,
English: 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.
Danish: Du må drikke op til 100 ml vand uden brus inden for 1 time før samt inden for 1 time efter indtagelse af Macimorelin Aeterna Zentaris.
English: The description in this leaflet is for your information on the testing procedure.
Danish: Beskrivelsen i indlægssedlen er blot til orientering.
English: What you need to know before Macimorelin Aeterna Zentaris is given
Danish: Det skal du vide, før du får Macimorelin Aeterna Zentaris
English: Step 6 Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Danish: Trin 6 Tag venøse blodprøver til test af væksthormonniveauet 45, 60 og 90 minutter efter administration.
English: What Macimorelin Aeterna Zentaris contains
Danish: Macimorelin Aeterna Zentaris indeholder:
English: Step 3
Danish: Trin 3
English: 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.
Danish: Bestem, hvor mange macimorelin breve der skal bruges, ud fra legemsvægten: Der skal bruges ét brev til en patient, der vejer op til 120 kg, og to breve til en patient, der vejer mere end 120 kg.
English: What you need to know before Macimorelin Aeterna Zentaris is given 3.
Danish: Det skal du vide, før du får Macimorelin Aeterna Zentaris 3.
English: 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.
Danish: Du vil få taget tre blodprøver til måling af væksthormon-niveauet (45, 60 og 90 minutter efter indtagelse af dosen).
English: Step 4
Danish: Trin 4
English: The suspension should be stirred until it is slightly turbid without particles at the bottom of the container.
Danish: Suspensionen omrøres, indtil der ikke er nogen partikler tilbage på bunden af beholderen (den er dog stadig lidt uklar).
English: • feeling hot
Danish: • varmefølelse.
English: crospovidone type A, saccharin sodium dihydrate and sodium stearyl fumarate (see section 2 under ‘Macimorelin Aeterna Zentaris contains sodium').
Danish: 2 under "Macimorelin Aeterna Zentaris indeholder lactose"), silica; kolloid vandfri, crospovidon type A, saccharinnatriumdihydrat og natriumstearylfumarat (se pkt.
English: Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Danish: Macimorelin Aeterna Zentaris 60 mg granulat til oral suspension i brev macimorelin
English: The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Danish: Eksempelvis vil en patient på 70 kg kræve 70 ml macimorelin suspension.
English: The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Danish: Den suspensionsmængde i ml, der skal bruges ved den anbefalede macimorelin dosis på 0,5 mg/kg, svarer til patientens legemsvægt i kg.
English: In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable.
Danish: Hos patienter i alderen op til 60 år var diagnosticeringseffektiviteten ved macimorelin-test (MAC-test) og insulintolerancetest (ITT-test) sammenlignelig.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret Andre informationskilder
English: NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Danish: LÆGEMIDLETS NAVN Macimorelin Aeterna Zentaris 60 mg granulat til oral suspension i brev
English: How Macimorelin Aeterna Zentaris is given 4.
Danish: Sådan skal du tage Macimorelin Aeterna Zentaris 4.
English: Potentially re-test needed in early disease
Danish: Ved tidlig sygdom kan en gentagelse af testen være nødvendig.
English: One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Danish: Der skal bruges ét brev til en patient ≤ 120 kg, og to breve til en patient, der vejer mere end 120 kg. Indholdet af ét brev opløses i 120 ml vand, og indholdet af to breve opløses i 240 ml vand.
English: 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.
Danish: Graden af overensstemmelse for negative resultater er andelen af forsøgspersoner med et negativt ITT-resultat (dvs. dem, der ikke har væksthormonmangel iht.
English: Unopened sachet
Danish: Uåbnet brev
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE BREV
English: Adult population
Danish: Voksne
English: How Macimorelin Aeterna Zentaris is given
Danish: Sådan skal du tage Macimorelin Aeterna Zentaris
English: • palpitations
Danish: • mavesmerter
English: ECG T wave abnormal
Danish: Unormal Ttak på EKG
English: • The other ingredients are: lactose monohydrate (see section 2 under ‘Macimorelin Aeterna Zentaris contains lactose'), colloidal anhydrous silica,
Danish: • Øvrige indholdsstoffer: lactosemonohydrat (se pkt.
English: • tremor
Danish: • træthed
English: 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.
Danish: Graden af overensstemmelse for positive resultater er andelen af forsøgspersoner med et positivt ITT-resultat (dvs. dem, der har væksthormonmangel iht.
English: Abdominal pain
Danish: Mave-tarm-kanalen
English: The following medicinal products may impact the accuracy of the diagnostic test. Concomitant use is to be avoided with (see also section 4.2 and section 4.4):
Danish: Samtidig anvendelse med nedenstående lægemidler skal undgås (se også pkt.
English: Renal and/or hepatic impairment
Danish: Nedsat nyre- og/eller leverfunktion
English: This document presents the conclusions on EACA.
Danish: Dette dokument fremlægger konklusionerne for EACA.
English: These concerns echoed those of a few published observational studies.
Danish: Disse betænkeligheder var af lignende art som dem, der fremgik af nogle få offentliggjorte observationsundersøgelser.
English: The latest quality review of documents templates were taken into account during this review.
Danish: Den seneste kvalitetsvurdering af dokumentskabelonerne blev taget i betragtning under dette gennemsyn.
English: • The Committee considered that the product information should be updated.
Danish: • Udvalget tog i betragtning, at produktoplysningerne bør opdateres.
English: The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007.
Danish: Markedsføringstilladelserne for aprotinin blev suspenderet, da der blev rejst betænkeligheder vedrørende dets sikkerhed ved en tidligere gennemgang i 2007.
English: The safety profile of EACA has evolved since its authorisation, and safety data has accumulated over the years.
Danish: Sikkerhedsprofilen for EACA har ændret sig siden lægemidlets godkendelse, og sikkerhedsdataene har akkumuleret sig over årene.
English: EACA had not previously been associated with an increased risk of mortality and this has remained unchanged postpublication of the BART study.
Danish: EACA har ikke tidligere været associeret med en højere dødsrisiko, og dette forblev uændret i den senere publicering af BART-undersøgelsen.
English: The marketing authorisations of EACA and TXA were not affected by the initial 2007 review.
Danish: Markedsføringstilladelserne for EACA og TXA blev ikke berørt af den første gennemgang i 2007.
English: The product information was modified to ensure that the information to healthcare professionals and patients is up to date.
Danish: Produktoplysningerne blev ændret for at sikre, at informationen til sundhedspersonale og patienter er opdateret.
English: Aminocaproic acid is a lysine analogue authorised for several indications since 1963.
Danish: Aminocapronsyre er en analog til lysin og har været godkendt til adskillige indikationer siden 1963.
English: 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.
Danish: I oktober 2011 afholdtes et møde i en videnskabelig rådgivende gruppe (SAG) nedsat af Udvalget for Lægemidler til Mennesker (CHMP), og CHMP tog gruppens standpunkter i betragtning ved denne gennemgang.
English: The results of the BART trial did not have a negative impact on the benefit risk profile of EACA.
Danish: Resultaterne af BARTundersøgelsen havde ikke nogen negativ indvirkning på EACA's benefit/risk-profil.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Danish: • Udvalget overvejede proceduren i henhold til artikel 31 i direktiv 2001/83/EF for aprotinin, aminocapronsyre og tranexamsyre (se bilag I).
English: Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes.
Danish: Aprotinin er et naturligt forekommende polypeptid, der er en inhibitor at proteolytiske enzymer.
English: 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.
Danish: I marts 2010 indledte Tyskland en artikel 31-indbringelse med henblik på at vurdere fordele og risici ved de antifibrinolytiske lægemidler aprotinin, EACA og TXA til alle de godkendte indikationer.
English: Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA).
Danish: CHMP udgav separate udtalelser og konklusioner for de tre antifibrinolytika (aprotinin, EACA og TXA).
English: Aminocaproic acid
Danish: Aminocapronsyre
English: It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein.
Danish: Det virker bredt på proteolytiske enzymer som plasmin, trypsin og kallikrein.
English: 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:
Danish: Idet al foreliggende information om sikkerhed og virkning blev taget i betragtning, indvilgede udvalget i ændring af markedsføringstilladelsen med en balance mellem risici og fordele, der blev anset som positiv, i følgende reviderede indikationer for EACA:
English: 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:
Danish: Derfor konkluderede CHMP, at benefit/risk-forholdet for aminocapronsyre er positivt under normale betingelser for anvendelse og revidering af indikationerne som følger:
English: 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.
Danish: Der blev foreslået ændringer til ordlyden til visse indikationer, så de blev opdateret i forhold til den aktuelle, videnskabelige viden om anvendelse af EACA.
English: • The Committee considered the available scientific data, including evidence from new studies, on the efficacy of EACA.
Danish: • Udvalget tog foreliggende videnskabelige data, inklusive evidens fra nye undersøgelser, om virkningen af EACA i betragtning.