FrancophonIA/ELRC3.0 huggingface dataset:
English: The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation.
Danish: Cut-off-værdien for macimorelin er ikke klarlagt i overgangsperioden fra senpubertet til fuldvoksen modenhed.
English: In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
Danish: Hos patienter i alderen 18-25 år var diagnosticeringseffektiviteten ved MAC testen og ITT testen sammenlignelig.
English: • infections (antibiotics such as rifabutin, rifampicin)
Danish: • infektioner (antibiotika som f.eks. rifabutin og rifampicin)
English: In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
Danish: Hos patienter med et højt BMI (op til 40 kg/m2) var diagnosticeringseffektiviteten ved MAC testen og ITT testen sammenlignelig.
English: The test was considered positive (i.e., growth hormone deficiency (GHD) diagnosed) if the maximum serum GH level observed after stimulation was less than the pre-specified cut-off point of 2.8 ng/mL for the MAC test or 5.1 ng/mL for the ITT.
Danish: Testen blev vurderet positiv (dvs. diagnose: væksthormonmangel), hvis det maksimale serumniveau af væksthormon, der sås efter stimulation, lå under den foruddefinerede cut-off-værdi på 2,8 ng/ml for MAC-testen og 5,1 ng/ml for ITT-testen.
English: Macimorelin acts like a natural hormone and causes the pituitary gland to release growth hormone into the blood stream.
Danish: Macimorelin virker ligesom et naturligt hormon og får hypofysen til at frigive væksthormon til blodbanen.
English: 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.
Danish: Macimorelin Aeterna Zentaris indeholder lactose Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, skal du tale med lægen, før du får dette lægemiddel.
English: Maximum GH levels have been observed approximately 45 to 60 minutes after administration of macimorelin.
Danish: Der er observeret maksimale væksthormonniveauer ca. 45-60 minutter efter administration af macimorelin.
English: The concomitant use with medicinal products that are known to induce torsades de pointes should be avoided (see also section 4.5).
Danish: Samtidig anvendelse af lægemidler, der inducerer torsades de pointes, bør undgås (se også pkt.
English: In patients with known congenital or acquired long QT syndrome and in patients with a history of torsades de pointes, the use of macimorelin may only be considered in a cardiovascular clinical unit.
Danish: Hos patienter med medfødt eller erhvervet langt QT-syndrom og hos patienter med tidligere torsades de pointes må anvendelse af macimorelin kun overvejes på en hjerteafdeling.
English: Frequency not known (cannot be estimated from the available data):
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): • ændringer i EKG (hjertediagram).
English: A liquid meal decreased the macimorelin Cmax and AUC by 0.42 and 0.5 fold, respectively.
Danish: Et flydende måltid medførte en reduktion af macimorelins Cmax og AUC på hhv. 0,42 og 0,5 gange.
English: Feeling cold Hunger Thirst
Danish: Kuldefølelse Sult
English: Post-hoc analysis with a cut-off point of 3.0 ng/mL for the ITT
Danish: Post hoc-analyse med en cut-off-værdi på 3,0 ng/ml for ITT-testen
English: This corresponds to a volume of 1 mL of the prepared suspension per kg body weight.
Danish: Det svarer til en mængde på 1 ml af den klargjorte suspension pr. kg legemsvægt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. brev, (23 mg) dvs. det er i det væsentlige natriumfrit.
English: An in vitro human liver microsomes study showed that CYP3A4 is the major enzyme to metabolize macimorelin.
Danish: Et in vitro-studie af humane levermikrosomer viste, at CYP3A4 er det vigtigste enzym ved metabolisering af macimorelin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Indeholder 60 mg macimorelin (som acetat) Efter rekonstitution: 500 mikrogram macimorelin/ml
English: Administration of a CYP3A4 inducer (such as carbamazepine, dabrafenib, efavirenz, enzalutamide, eslicarbazepine, fosphenytoin, lumacaftor, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, pitolisant, primidone, rifabutin, rifampicin and St John's wort (Hypericum perforatum)) may reduce the plasma macimorelin concentrations and may affect the diagnostic performance of the test and therefore should be avoided.
Danish: Administration af en CYP3A4-inducer (f.eks. carbamazepin, dabrafenib, efavirenz, enzalutamid, eslicarbazepin, fosphenytoin, lumacaftor, modafinil, nevirapin, oxcarbazepin, phenobarbital, phenytoin, pioglitazon, pitolisant, primidon, rifabutin, rifampicin og prikbladet perikum (Hypericum perforatum)) kan reducere plasmakoncentrationen af macimorelin og påvirke testens diagnosticeringseffektivitet og bør derfor undgås.
English: Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively.
Danish: Punktestimater for sensitivitet og specificitet var hhv. 87 % og 96 % for ikke-matchede gruppe A-forsøgspersoner.
English: Maximal GH release has been observed at macimorelin plasma concentrations of ≥ 7 ng/mL.
Danish: Maksimal frigivelse af væksthormon er set ved plasmakoncentrationer af macimorelin på ≥ 7 ng/ml.
English: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process.
Danish: Væksthormonmangel hos voksne, der skyldes en læsion i hypothalamus, kan måske ikke detekteres tidligt i sygdommens udvikling.
English: Macimorelin Aeterna Zentaris contains sodium This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say it is essentially “sodium-free”.
Danish: Macimorelin Aeterna Zentaris indeholder natrium Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. brev, dvs. det er i det væsentlige natriumfrit.
English: Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus.
Danish: Macimorelin virker nedstrøms fra hypothalamus, og macimorelinstimuleret frigivelse af lagrede væksthormonreserver fra hypofysens forlap kan give et falsk negativt resultat tidligt, hvis læsionen involverer hypothalamus.
English: Macimorelin Aeterna Zentaris is used in adults to test the body´s ability to produce growth hormone.
Danish: Macimorelin Aeterna Zentaris anvendes hos voksne for at undersøge kroppens evne til at producere væksthormon.
English: 1 mL of the reconstituted suspension contains 500 micrograms macimorelin.
Danish: 1 ml rekonstitueret suspension indeholder 500 mikrogram macimorelin.
English: 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%).
Danish: 5.1) hos 154 patienter, var dysgeusi (5 %), hovedpine, træthed, kvalme (3 % hver), svimmelhed (2 %) samt mavesmerter, diarré, varmefølelse, kuldefølelse, sult, palpitationer, sinusbradykardi, somnolens, tørst, tremor og vertigo (1 % hver).
English: Strong CYP3A4 inducers should be discontinued and a washout time of five elimination half-lives should be considered prior to test administration.
Danish: Stærke CYP3A4-inducere bør seponeres, idet en udvaskningsperiode på fem eliminationshalveringstider inden administration af macimorelin bør overvejes.
English: The use of Macimorelin Aeterna Zentaris must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency.
Danish: Brug af Macimorelin Aeterna Zentaris skal overvåges af en læge eller sundhedsperson med erfaring i diagnosticering af væksthormonmangel.
English: Macimorelin Aeterna Zentaris has minor influence on the ability to drive and use machines.
Danish: Macimorelin Aeterna Zentaris kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: LIST OF EXCIPIENTS Contains lactose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder laktose.
English: • medicines to treat infections (antibiotics such as erythromycin, clarithromycin, moxifloxacin)
Danish: • lægemidler mod infektioner (antibiotika som f.eks. erythromycin, clarithromycin og moxifloxacin)
English: Women of childbearing potential must use adequate contraceptive methods at the time when macimorelin will be administered.
Danish: Kvinder, der kan blive gravide, skal bruge sikker prævention på det tidspunkt, hvor macimorelin skal administreres.
English: Macimorelin should be used with caution in patients with proarrhythmic condition (e.g., history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
Danish: Macimorelin bør anvendes med forsigtighed hos patienter med proarytmiske tilstande (f.eks. tidligere myokardieinfarkt, hjerteinsufficiens eller forlænget QTc-interval (QTc > 500 ms)).
English: • you have heart disease or problems with your heart rhythm (including congenital or acquired long QT syndrome or a history of so called torsades de pointes tachycardias).
Danish: • hvis du har hjertesygdom eller problemer med din hjerterytme (herunder medfødt eller erhvervet langt QT-syndrom eller tidligere torsades de pointes-takykardi).
English: The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight.
Danish: Den anbefalede dosis er 0,5 mg Macimorelin Aeterna Zentaris pr. kg legemsvægt.
English: Macimorelin Aeterna Zentaris is not recommended during pregnancy.
Danish: Macimorelin Aeterna Zentaris anbefales ikke under graviditet.
English: Macimorelin induced GH release was lower in patients with higher BMI.
Danish: Macimorelininduceret frigivelse af væksthormon var lavere hos patienter med et højere BMI.
English: A similar increase in the QTcF interval was also observed in a single-ascending dose study, which included three dose levels (0.5 mg/kg, 1 mg/kg and 2 mg/kg (2 times and 4 times the recommended dosage, respectively)).
Danish: En tilsvarende stigning i QTcF-intervallet sås også i et studie med stigende enkeltdosis, der omfattede tre dosisniveauer (0,5 mg/kg, 1 mg/kg og 2 mg/kg (hhv. 2 og 4 gange den anbefalede dosis)).
English: Macimorelin Aeterna Zentaris can cause changes in the ECG (electrocardiogram) including QT prolongation that are associated with an increased risk for arrhythmias.
Danish: Macimorelin Aeterna Zentaris kan medføre forandringer i EKG-målinger (hjertediagram), herunder forlængelse af QTintervallet, der er forbundet med en øget risiko for hjerterytmeforstyrrelser.
English: Based on current understanding, this is unlikely to decrease the specificity of the test.
Danish: Efter gængs opfattelse er det ikke sandsynligt, at dette vil reducere målingernes specificitet.
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1).
Danish: Macimorelin forårsager en stigning på ca. 11 ms i det korrigerede QT-interval (QTc-intervallet) ved en ukendt mekanisme (se også pkt.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aeterna Zentaris GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Aeterna Zentaris GmbH
English: • Drinking - up to 100 mL of still water is allowed each within 1 hour before as well as within 1 hour after macimorelin intake.
Danish: • Drikke - du må drikke op til 100 ml vand uden brus inden for 1 time før samt inden for 1 time efter indtagelse af macimorelin.
English: In patients with a QTc > 500 ms, an ECG monitoring should be applied (see section 4.4 and 5.1).
Danish: Patienter med QTc > 500 ms bør EKG-monitoreres (se pkt.
English: Marketing Authorisation Holder and Manufacturer Aeterna Zentaris GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller Aeterna Zentaris GmbH
English: Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg.
Danish: Beregn, hvor stor en mængde suspension der er nødvendig for at opnå den anbefalede dosis macimorelin på 0,5 mg/kg.
English: • you have recently been treated with growth hormone (somatotropin) or with medicines that affect the secretion of growth hormone by the pituitary gland.
Danish: • hvis du for nylig er blevet behandlet med væksthormon (somatotropin) eller lægemidler, der påvirker hypofysens udskillelse af væksthormon.
English: Dissolve the entire contents of the sachet in water: one sachet in 120 mL, two sachets in 240 mL, as applicable.
Danish: Opløs hele brevindholdet i vandet: ét brev i 120 ml, to breve i 240 ml.
English: CYP3A4 is the major enzyme to metabolize macimorelin.
Danish: CYP3A4 er det vigtigste enzym ved metabolisering af macimorelin.
English: Macimorelin Aeterna Zentaris is indicated for the diagnosis of growth hormone deficiency (GHD) in adults (see section 5.1).
Danish: Macimorelin Aeterna Zentaris er indiceret til diagnosticering af væksthormonmangel (GHD) hos voksne (se pkt.
English: In a diagnostic study comparing macimorelin with the insulin tolerance test (ITT) stimulated GH concentrations after macimorelin were on average 1.4 fold higher than in the ITT.
Danish: I et diagnostisk studie, der sammenlignede macimorelin-test med insulintolerancetest (ITT-test), var de stimulerede væksthormonkoncentrationer ved brug af macimorelin i gennemsnit 1,4 gange højere end ved brug af ITT-test.
English: Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin.
Danish: Macimorelin er et oralt tilgængeligt peptidomimetikum med væksthormon-sekretagog aktivitet svarende til ghrelin.
English: Concomitant use of strong CYP3A4 inducers with Macimorelin Aeterna Zentaris can decrease macimorelin plasma levels significantly and thereby lead to a false positive result (see also section 4.5).
Danish: Brug af CYP3A4-inducere samtidig med Macimorelin Aeterna Zentaris kan nedsætte plasmakoncentrationen af macimorelin signifikant og dermed føre til falsk positive testresultater (se også pkt.
English: The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2).
Danish: Sikkerheden og virkningen af macimorelin hos patienter med nedsat nyre- og/eller leverfunktion er ikke klarlagt (se også pkt.
English: The medicine contains an active substance called macimorelin.
Danish: Lægemidlet indeholder det aktive stof macimorelin.
English: A dose of 0.5 mg/kg macimorelin was shown to induce maximal GH release.
Danish: Det blev påvist, at en dosis på 0,5 mg/kg macimorelin inducerer maksimal frigivelse af væksthormon.
English: A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Danish: Et potentiale for øget oral biotilgængelighed og plasmakoncentration af macimorelin ved brug af stærke CYP3A4/P-gp-hæmmere kan ikke udelukkes.
English: Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval (see section 5.1).
Danish: Macimorelin forårsager en stigning på ca. 11 ms i det korrigerede QT-interval (QTc-intervallet) (se pkt.
English: The EMA has deferred the obligation to submit the results of studies with Macimorelin Aeterna Zentaris in one or more subsets of the paediatric population in the diagnosis of growth hormone deficiency (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Macimorelin Aeterna Zentaris i en eller flere undergrupper af den pædiatriske population ved diagnosticering af væksthormonmangel (se pkt.
English: The estimates for negative and positive agreement were 95% and 86% with lower 95% confidence interval bounds 87% and 75%, respectively.
Danish: Estimaterne for overensstemmelse for negative og positive resultater var hhv. 95 % og 86 % med nedre grænser for 95 % konfidensintervaller på hhv. 87 % og 75 %.
English: • medicines to treat psychosis (such as chlorpromazine, haloperidol)
Danish: • lægemidler mod psykose (f.eks. chlorpromazin og haloperidol)
English: Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Danish: Macimorelin er indiceret til indgift som enkeltdosis ved diagnostisk test. Der foreligger ingen data om macimorelins sikkerhed og virkning ved længerevarende brug.
English: 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).
Danish: • hvis du er allergisk over for macimorelin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: If you are not sure, talk to your doctor or nurse before you are given Macimorelin Aeterna Zentaris.
Danish: Hvis du er i tvivl, så spørg lægen eller sundhedspersonalet, før du får Macimorelin Aeterna Zentaris.
English: For both the ITT and the MAC test, serum concentrations of GH were measured at 30, 45, 60 and 90 minutes after administration.
Danish: For både ITT- og MAC-testen blev serumkoncentrationen af væksthormon målt 30, 45, 60 og 90 minutter efter administration.
English: Macimorelin stimulates GH release by activating growth hormone secretagogue receptors (GHSR) present in the pituitary and hypothalamus.
Danish: Macimorelin stimulerer frigivelse af væksthormon ved at aktivere de væksthormon-sekretagoge receptorer (GHSR) i hypofysen og hypothalamus.
English: Paediatric population The safety and efficacy of macimorelin in children and adolescents below 18 years have not yet been established (see also section 5.2).
Danish: Macimorelins sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt (se også pkt.
English: Repeat testing may be warranted in this situation.
Danish: I denne situation kan det være nødvendigt med gentagne test.
English: • 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.
Danish: • hvis din krop mangler et andet hormon, f.eks. kortisol, skjoldbruskkirtelhormon, kønshormon eller vasopressin (ved diabetes insipidus); en sådan tilstand skal behandles med relevant erstatningsterapi, før testen for væksthormonmangel kan gennemføres.
English: The diagnostic efficacy of Macimorelin Aeterna Zentaris was established in a randomized, open-label, single dose, cross-over study (AEZS-130-052) comparing the level of agreement between the macimorelin test (MAC) results and insulin tolerance test (ITT) results.
Danish: Diagnosticeringseffektiviteten ved Macimorelin Aeterna Zentaris blev klarlagt i et åbent, randomiseret overkrydsnings-enkeltdosisstudie (AEZS-130-052), der sammenlignede overensstemmelsesgraden mellem MAC-testresultaterne og ITT-testresultaterne.
English: 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.
Danish: Patienter, der også lider af anden hormonmangel ud over eventuel væksthormonmangel (f.eks. binyre-, thyroidea- og/eller gonade-insufficiens, diabetes insipidus), bør have tilstrækkelig erstatningsterapi med de andre manglende hormoner, inden der testes for manglende væksthormonstimulation, for at udelukke, at eventuel stimulationsmangel skyldes sekundær væksthormonmangel.
English: Items needed: Macimorelin Aeterna Zentaris sachet, tap water in decanter, graduated glass or transparent plastic container, stirring device, 50 mL graduated syringe without needle, drinking glass
Danish: Nødvendigt udstyr: Macimorelin Aeterna Zentaris-brev, postevand i en kande, målebæger af glas eller gennemsigtig plast, rørepind, 50 ml målesprøjte uden kanyle, et drikkeglas
English: Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin
Danish: Seponering af behandling med væksthormon eller lægemidler med direkte indvirkning på hypofysens udskillelse af somatotropin
English: Co-administration of a CYP3A4 inhibitor may increase the macimorelin plasma concentration, and this, in turn, could yield higher plasma GH levels.
Danish: Samtidig administration af en CYP3A4-hæmmer kan øge plasmakoncentrationen af macimorelin, hvilket igen kan give højere plasmaniveauer af væksthormon.
English: Patients with a deficiency affecting hormones other than growth hormone (GH)
Danish: Patienter, der også lider af anden hormonmangel ud over eventuel væksthormonmangel
English: In dose finding studies in healthy subjects, maximum stimulation of GH secretion was achieved following single dose administration of 0.5 mg/kg macimorelin.
Danish: I dosisbestemmende studier hos raske forsøgspersoner opnåedes maksimal stimulation af væksthormonudskillelse efter administration af en enkeltdosis på 0,5 mg/kg macimorelin.
English: Negative and positive agreement between MAC and the ITT in subjects with intermediate or low risk (Groups B and C) were 93% and 61% with lower 95% confidence interval bounds 80% and 43%, respectively.
Danish: Overensstemmelse for negative og positive resultater mellem MAC-testen og ITT-testen hos forsøgspersoner med mellemstor eller lav risiko (gruppe B og C) var hhv. 93 % og 61 % med nedre grænser for 95 %-konfidensintervaller på hhv. 80 % og 43 %.
English: This study showed a mean baseline- and placebo-adjusted change (upper single-sided 95% confidence interval) in QTcF of 9.6 ms (11.4 ms) at 4 h post-dose (see also section 4.4), which occurred after the mean maximum macimorelin plasma concentration (0.5 h).
Danish: Studiet viste en gennemsnitlig baseline- og placebo-justeret ændring (øvre enkeltsidet 95 %-konfidensinterval) i QTcF på 9,6 ms (11,4 ms) 4 t efter administration (se også pkt.
English: 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.
Danish: Macimorelin Aeterna Zentaris er indiceret til indtagelse som enkeltdosis i forbindelse med diagnostisk test. Der foreligger ingen data om macimorelins sikkerhed og virkning ved længerevarende brug.
English: EXPIRY DATE
Danish: 8.UDLØBSDATO EXP
English: Dysgeusia (bitter/metallic taste)
Danish: Dysgeusi (bitter/metallisk smag) Somnolens Svimmelhed
English: An exploratory analysis was conducted on the performance of the MAC based on an ITT cut-off point of 3.0 ng/mL.
Danish: Der blev foretaget en eksplorativ analyse af MAC-testens effektivitet baseret på en cut-off-værdi for ITT-testen på 3,0 ng/ml.
English: The estimates for negative and positive agreement between MAC and the ITT in the overall study population were 94% and 74% with lower 95% confidence interval bounds 85% and 63%, respectively.
Danish: Estimaterne for overensstemmelse for negative og positive resultater mellem MAC-testen og ITTtesten i den samlede population var hhv. 94 % og 74 % med nedre grænser for 95 % konfidensintervaller på hhv. 85 % og 63 %.
English: Each sachet contains 60 mg macimorelin (as acetate).
Danish: Hvert brev indeholder 60 mg macimorelin (som acetat).
English: PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Danish: Granulat til oral suspension i brev.