FrancophonIA/ELRC3.0 huggingface dataset:
English: Reconstituted suspension
Danish: Rekonstitueret suspension
English: Adverse reactions reported in Study 052 are listed below by MedDRA body system organ class and by frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Danish: De bivirkninger, der blev rapporteret i studie 052, er opstillet nedenfor efter MedDRA systemorganklasse og hyppighed: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: 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.
Danish: 38 (27 %) i gruppe A, 37 (26 %) i gruppe B, 40 (29 %) i gruppe C og 25 (18 %) i gruppe D. Én ud af 154 MAC-test (0,6 %) fejlede på grund af et teknisk problem, og 27 ud af 157 ITT-test (17,2 %) fejlede, fordi induktion af svær hypoglykæmi (dvs. stimulussen) ikke kunne opnås.
English: 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.
Danish: I aldersgruppen 6065 år tyder de begrænsede data ikke på noget behov for en separat cut-off-værdi.
English: In case a patient should be reporting dizziness as side effect, the patient should be instructed to neither drive nor use machines.
Danish: En patient, der rapporterer svimmelhed som bivirkning, skal instrueres i hverken at føre motorkøretøj eller betjene maskiner.
English: 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.
Danish: Som med alle væksthormonstimulationstest skal resultaterne af macimorelin testen også altid fortolkes ud fra udfaldet af alle undersøgelser i den diagnostiske vurdering af en patient.
English: The suspension should be stirred again, when some particles settle at the bottom of the container for example after the suspension is left standing for some time.
Danish: Suspensionen bør omrøres på ny, hvis nogle af partiklerne lægger sig på bunden af beholderen, f.eks. hvis suspensionen efterlades i et stykke tid.
English: The level of negative and positive agreement between the results of the ITT and the MAC test was used to evaluate the performance of the MAC test.
Danish: Overensstemmelsesgraden mellem negative og positive resultater for ITT-testen og MAC-testen blev brugt til at vurdere MAC-testens effektivitet.
English: Step 1 Weigh the patient.
Danish: Trin 1 Vej patienten.
English: In the event of an overdose, symptomatic and supportive measures should be employed.
Danish: Ved overdosering gives symptomatisk og understøttende behandling.
English: This medicinal product contains lactose.
Danish: Dette lægemiddel indeholder laktose.
English: The median age was 41 years (range: 18 - 66 years) and body mass index 27.5 kg/m2 (range: 16 - 40 kg/m2).
Danish: Den mediane alder var 41 år (interval: 18-66 år), og BMI var 27,5 kg/m2 (interval: 16-40 kg/m2).
English: One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box.
Danish: Et LDPE/ALU/LDPE/papir-brev, der indeholder 1,817 mg granulat, og som er emballeret i en kartonæske.
English: Tell your doctor if you are taking medicines that can alter your heart rhythm, such as:
Danish: Fortæl det til lægen, hvis du tager lægemidler, der kan ændre din hjerterytme, f.eks.:
English: Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM.
Danish: Bindingen til plasmaproteiner falder ved øgede koncentrationer (fra 78 % ved 0,1 µM til 62 % ved 10 µM).
English: Reconstituted suspension:
Danish: Rekonstitueret suspension:
English: • any other medicines that can prolong the QT interval or inducing torsades de pointes
Danish: • ethvert andet lægemiddel, der kan forlænge QT-intervallet eller inducere torsades de pointes.
English: Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours.
Danish: Macimorelin blev elimineret med en gennemsnitlig terminal halveringstid (T1/2) på 4,1 t.
English: 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.
Danish: Patienter med arvelig galaktoseintolerans, total laktasemangel eller glukose/galaktose-malabsorption bør kun få dette lægemiddel, hvis den forventede fordel ved testen tydeligt opvejer den risiko, der kan være forbundet med indtagelse af maksimalt 1.691,8 mg laktose pr. brev.
English: If this happens, do not drive or use machines.
Danish: Hvis du føler sig svimmel, må du ikke køre motorkøretøj eller betjene maskiner.
English: Macimorelin Aeterna Zentaris granules are to be reconstituted with water and must be used within 30 minutes after preparation.
Danish: Macimorelin Aeterna Zentaris granulat rekonstitueres med vand og skal anvendes inden for 30 minutter efter klargøring.
English: Information about lactose and sodium
Danish: Oplysninger om laktose og natrium
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: • hunger
Danish: • sult
English: 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.
Danish: Macimorelin Aeterna Zentaris må ikke anvendes hos børn og unge under 18 år, da sikkerheden og virkningen i denne gruppe ikke er fastlagt endnu.
English: The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2.
Danish: Sikkerheden og diagnosticeringseffektiviteten ved macimorelin testen er ikke klarlagt hos patienter med et BMI > 40 kg/m2.
English: SPECIAL STORAGE CONDITIONS Reconstituted suspension:
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Rekonstitueret suspension:
English: Any suspension that remains must not be stored and must be discarded.
Danish: Eventuel tiloversbleven suspension må ikke gemmes, men skal bortskaffes.
English: The efficacy of macimorelin in patients aged over 65 years has not been established.
Danish: Macimorelins virkning hos patienter over 65 år er ikke klarlagt.
English: Hypercortisolism has a significant impact on the hypothalamic-pituitary-adrenal axis.
Danish: Hyperkortisolisme har signifikant indvirkning på hypothalamus-hypofyse-binyre-aksen.
English: If occurring, such changes would be timely limited and not last long.
Danish: Disse eventuelle forandringer vil være midlertidige og kortvarige.
English: Tell your doctor if you are taking medicines that could increase the breakdown of macimorelin such as specific medicines to treat:
Danish: Fortæl det til lægen, hvis du tager medicin, der kan øge nedbrydningen af macimorelin, f.eks. specifikke lægemidler til behandling af:
English: Macimorelin is moderately bound to plasma proteins.
Danish: Macimorelin binder i moderat grad til plasmaproteiner.
English: The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years.
Danish: Macimorelins farmakodynamik er ikke tilstrækkeligt undersøgt hos ældre i alderen > 65 år.
English: 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)).
Danish: Fire grupper personer blev undersøgt: Tre grupper af voksne patienter med forskellig sandsynlighed for væksthormonmangel forud for testen (gruppe A (stor sandsynlighed), gruppe B (mellemstor sandsynlighed), gruppe C (lille sandsynlighed) samt gruppe D (raske forsøgspersoner)).
English: Growth hormone medicinal products should be discontinued at least 1 month before administering macimorelin.
Danish: Væksthormonmidler bør seponeres mindst 1 måned før administration af macimorelin.
English: • HIV (efavirenz, nevirapine)
Danish: • hiv (efavirenz og nevirapin)
English: 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.
Danish: Macimorelin blev absorberet hurtigt, og de maksimale plasmakoncentrationer (Cmax) sås ca. 30 minutter til 1 time og 10 minutter efter oral administration af 0,5 mg/kg macimorelin efter mindst 8 timers faste.
English: Each cardboard box contains 1 sachet.
Danish: Hver kartonæske indeholder 1 brev.
English: In such a situation, a repetition of the test may be required.
Danish: I dette tilfælde kan en gentagelse af testen være nødvendig.
English: No studies have been conducted to evaluate the pharmacokinetics of macimorelin in paediatric patients or in patients with renal or hepatic impairment.
Danish: Der er ikke udført studier til undersøgelse af macimorelins farmakokinetik hos pædiatriske patienter eller patienter med nedsat nyre- eller leverfunktion.
English: Point estimates for sensitivity ranged from 0.87 to 0.90 for the MAC and from 0.97 to 1.0 for the ITT, depending on the inclusion or exclusion of data from not matched Group A subjects, respectively.
Danish: Punktestimater for følsomhed lå fra 0,87 til 0,90 for MAC-testen og fra 0,97 til 1,0 for ITT-testen, afhængigt af hhv. medtagelse eller udelukkelse af data fra ikke-matchede gruppe A-forsøgspersoner.
English: Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need.
Danish: Generelt var der tale om primært lette bivirkninger af kort varighed uden specifikt behandlingsbehov.
English: Prepare plasma or serum samples and send to a laboratory for growth hormone determination.
Danish: Klargør plasma- eller serumprøver, og send dem til et laboratorium med henblik på bestemmelse af væksthormonniveauet.
English: During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions.
Danish: Under den kliniske udvikling er to forbigående EKG-forandringer set hos én forsøgsperson og rapporteret som mulige alvorlige bivirkninger.
English: 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.
Danish: Kliniske studier har vist, at et maksimalt stimuleret væksthormonniveau i serum på under 2,8 ng/ml (efter hhv. 45, 60 og 90 minutter) efter administration af macimorelin bekræfter diagnosen væksthormonmangel hos voksne.
English: Potential for false positive test results with use of strong CYP3A4 inducers
Danish: Potentiale for falsk positive testresultater ved brug af stærke CYP3A4-inducere
English: If you are breast-feeding or intend to breast-feed, a risk to the suckling child cannot be excluded.
Danish: Hvis du ammer eller har planlagt at amme, kan en risiko for det ammede barn ikke udelukkes.
English: Other hormone deficiencies if untreated could lead to inaccurate results in the growth hormone stimulation test.
Danish: Andre hormonmangler kan ubehandlet medføre unøjagtige resultater af væksthormonstimulationstesten
English: For such patients, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin.
Danish: Hos sådanne patienter kan EKG-målinger være indiceret inden administration af macimorelin samt 1 time, 2 timer, 4 timer og 6 timer efter administration af macimorelin.
English: Studies in animals are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige, hvad angår reproduktionstoksicitet (se pkt.
English: Macimorelin is metabolised mainly by CYP3A4 in vitro.
Danish: Macimorelin metaboliseres hovedsagelig af CYP3A4 in vitro.
English: 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.
Danish: Hvis væksthormonmanglen først er startet for nylig, og hvis manglen skyldes en skade i den del af hjernen, der hedder hypothalamus, kan resultatet af testen være negativt, selvom du har sygdommen.
English: These results are based on peak GH values (maximum GH concentrations across all measurement timepoints).
Danish: Disse resultater er baseret på højeste væksthormonværdier (maksimale væksthormonkoncentrationer på tværs af alle måletidspunkter).
English: All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes.
Danish: Alle de tre undersøgte dosisniveauer viste QTcF-forlængelse af samme størrelsesorden i det grundige QT-studie, hvilket peger på, at ændringerne ikke er dosisafhængige.
English: Add required volume of water in a graduated glass or transparent plastic container.
Danish: Kom den nødvendige mængde vand i et målebæger af glas eller gennemsigtig plast.
English: 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.
Danish: Begge co-primære endepunkter som foruddefineret i studie 052 (nedre grænse for 95 %-KI for overensstemmelse mellem negative resultater ≥ 75 %, nedre grænse for 95 % KI for overensstemmelse mellem positive resultater ≥ 70 %) opfyldes, når der anvendes en cut-off-værdi for ITT-testen på 3,0 ng/ml og en foruddefineret cut-off-værdi for MAC-testen på 2,8 ng/ml.
English: • sleep disorder (modafinil, pitolisant)
Danish: • søvnforstyrrelser (modafinil og pitolisant)
English: In case you should have heart rhythm disturbances, an ECG monitoring will be performed.
Danish: Hvis du har fået hjerterytmeforstyrrelser, vil der blive taget et EKG (hjertediagram).
English: If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded.
Danish: Hvis macimorelin administreres til patienter med nedsat nyre- og/eller leverfunktion, kan potentialet for en øget macimorelin-koncentration i plasma ikke udelukkes.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: White to off-white granules.
Danish: Hvidt til råhvidt granulat.
English: Studies to detect macimorelin metabolites did not identify any metabolites.
Danish: I studier til undersøgelse af macimorelins metabolitter er der ikke identificeret nogen metabolitter.
English: The oral bioavailability may be limited (among others) by first pass metabolism via CYP3A4 (see section 4.5).
Danish: Den orale biotilgængelighed kan være begrænset af (bl.a.) første-passage metabolisering via CYP3A4 (se pkt.
English: 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.
Danish: Den rekonstituerede suspension skal administreres oralt til patienter, der har fastet i mindst 8 timer, og som ikke har udført anstrengende fysisk aktivitet 24 timer inden testen, da både mad og fysisk aktivitet kan påvirke niveauet af væksthormon.
English: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases.
Danish: QT-forlængelse kan føre til udvikling af torsades de pointeslignende ventrikulær takykardi, idet risikoen øges med graden af QT-forlængelse.
English: Macimorelin is not recommended during pregnancy.
Danish: Macimorelin anbefales ikke under graviditet.
English: 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.
Danish: Derfor kan testens diagnosticeringseffektivitet blive påvirket hos patienter med Cushings sygdom eller i suprafysiologisk glukokortikoidbehandling (f.eks. systemisk administration af hydrokortisondoser (eller tilsvarende) på mere end 15 mg/m2/dag), hvilket kan føre til falsk positive testresultater.
English: Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy
Danish: Patienter med Cushings sygdom eller i suprafysiologisk glukokortikoidbehandling
English: GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK).
Danish: Væksthormonniveauerne blev fastlagt centralt ved IDS-iSYS-analyse (Immunodiagnostic Systems Ltd., Storbritannien).
English: • mild to moderate depressive episodes (St. John´s wort (Hypericum perforatum))
Danish: • lette til moderate depressive episoder (prikbladet perikum (Hypericum perforatum))
English: Lactose monohydrate Colloidal anhydrous silica Crospovidone type A Saccharin sodium dihydrate Sodium stearyl fumarate
Danish: Lactosemonohydrat Silica, kolloid vandfri Crospovidon type A Saccharinnatriumdihydrat Natriumstearylfumarat
English: Do not use this medicine after the expiry date which is stated on the outer carton and the sachet after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og brevet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • a bitter or metallic taste (dysgeusia)
Danish: • en bitter eller metallisk smag (dysgeusi)
English: DIRECTIONS FOR PREPARATION AND USE
Danish: VEJLEDNING I KLARGØRING OG ANVENDELSE
English: 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
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • The active substance is macimorelin.
Danish: • Aktivt stof: macimorelin.
English: Sensitivity and specificity for both growth hormone stimulation tests (GHSTs) were estimated, assuming all high likelihood AGHD subjects of Group A as ‘true' AGHD subjects and all healthy matching subjects of Group D as ‘true' AGHD negative subjects.
Danish: Følsomheden og specificiteten for begge væksthormonstimulationstest blev estimeret, idet alle forsøgspersoner med stor sandsynlighed for at have væksthormonmangel (gruppe A) blev betragtet som "ægte" positive, og idet alle de raske forsøgspersoner i gruppe D blev betragtet som "ægte" negative.
English: 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
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Based on current understanding, this potential is unlikely to decrease the specificity of the test.
Danish: Efter gængs opfattelse er det ikke sandsynligt, at dette potentiale vil reducere målingernes specificitet.
English: For both GHSTs, the estimated specificity was 0.96, irrespective of the in/exclusion data from not matched Group A subjects.
Danish: For begge væksthormonstimulationstest var den estimerede specificitet 0,96, uafhængigt af medtagelse eller udelukkelse af data fra ikke-matchede gruppe A-forsøgspersoner.
English: • 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.
Danish: • hvis du for nylig er blevet behandlet for Cushings sygdom (en forstyrrelse, der medfører et højt niveau af hormonet kortisol), eller hvis du får en høj dosis hydrokortison, da testen i så fald kan medføre et falsk positivt resultat
English: Dizziness has been reported by some patients taking macimorelin.
Danish: Der er rapporteret om svimmelhed af nogle patienter, der har fået macimorelin.
English: Talk to your doctor or nurse if:
Danish: Tal med lægen eller sundhedspersonalet:
English: Residual suspension must be discarded according to local regulations.
Danish: Rester af suspensionen skal bortskaffes i henhold til lokale retningslinjer.
English: You must be fasting for at least 8 hours before you are given Macimorelin Aeterna Zentaris.
Danish: Du skal have fastet i mindst 8 timer, før du får Macimorelin Aeterna Zentaris.
English: • cancer (dabrafenib, enzalutamide)
Danish: • kræft (dabrafenib og enzalutamid).
English: Each sachet contains 1,817 mg granules.
Danish: Hvert brev indeholder 1.817 mg granulat.
English: Measure the required volume using a 50 mL graduated syringe without a needle.
Danish: Opmål den ønskede mængde ved hjælp af en 50 ml målesprøjte uden kanyle.
English: Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended.
Danish: En tilstrækkelig udvaskningsperiode (fem eliminationshalveringstider) for de pågældende lægemidler inden administration af macimorelin anbefales.
English: Drug-drug interaction studies with CYP3A4/P-gp-inhibitors have not been conducted.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med CYP3A4/P-gp-hæmmere.
English: • seizures/epilepsy (carbamazepine, esclicarbazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone)
Danish: • krampeanfald/epilepsi (carbamazepin, esclicarbazepin, fosphenytoin, oxcarbazepin, phenobarbital,
English: 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.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med macimorelin seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Cardiac electrophysiology
Danish: Hjertets elektrofysiologi
English: 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
Danish: Ved den klinisk relevante koncentration på 0,1 µM (klinisk Cmax = 11,2 ng/ml = ca. 0,02 µM) er den ubundne fraktion af macimorelin i humant plasma 22 %.
English: Possible side effects in cases of overdosing could include headache, nausea, vomiting and diarrhoea.
Danish: Mulige bivirkninger i tilfælde af overdosering omfatter hovedpine, kvalme, opkastning og diarré.
English: A healthcare professional must supervise the preparation and use of Macimorelin Aeterna Zentaris.
Danish: En sundhedsperson skal overvåge klargøringen og anvendelsen af Macimorelin Aeterna Zentaris.
English: Please ask your doctor whether to discontinue breast-feeding or to abstain from the macimorelin test.
Danish: Spørg lægen, om du skal holde op med at amme, eller om du skal lade være med at få foretaget macimorelin-testen.
English: 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).
Danish: Derfor kan EKGmålinger være indiceret inden administration af macimorelin samt 1 time, 2 timer, 4 timer og 6 timer efter administration af macimorelin (se også pkt.