FrancophonIA/ELRC3.0 huggingface dataset:
English: In embryo-foetal development studies in rats and rabbits, increased numbers of late resorptions, reduced foetal weight and reduced skeletal ossification were observed.
Danish: I studier af embryoføtal udvikling hos rotter og kaniner blev der observeret en øgning i antallet af sene resorptioner, reduktion i fostervægt og reduktion i skeletal ossifikation.
English: In the ASM, SM-AHN and MCL population, 25.4% of patients had at least one ECG measurement with a QTcF greater than 450 ms and 4.7% greater than 480 ms.
Danish: Hos populationen med ASM, SM-AHN og mastcelleleukæmi havde 25,4 % af patienterne mindst én EKGoptagelse med et QTcF-interval, der var bredere end 450 ms, og 4,7 % havde et, der var bredere end 480 ms.
English: What you need to know before you take Rydapt
Danish: Det skal du vide, før du begynder at tage Rydapt
English: Midostaurin inhibited OATP1B1, BCRP and P-glycoprotein (P-gp) in vitro (see section 5.2).
Danish: Midostaurin hæmmede OATP1B1, BCRP og P-glykoprotein (P-gp) in vitro (se pkt.
English: INTERMEDIATE CARTON
Danish: INTERMEDIÆR KARTON
English: If vomiting occurs, the patient should not take an additional dose of Rydapt, but should take the next scheduled dose.
Danish: I tilfælde af opkastning skal patienten ikke tage en ny dosis af Rydapt, men bør tage den næste dosis som planlagt.
English: Midostaurin interferes with aberrant KIT D816V-mediated signalling and inhibits mast cell proliferation, survival and histamine release.
Danish: Midostaurin interfererer med abnorm KIT D816V-medieret signalering og hæmmer mastcellers proliferation, overlevelse og histaminfrigørelse.
English: 33.9 months (95% CI: 20.7, 42), than for KIT D816V wild type or unknown patients, i.e. 10 months (95% CI: 6.9, 17.4).
Danish: 33,9 måneder (95% CI: 20,7, 42), end for KIT D816V vildtype eller ukendte patienter; 10 måneder (95% CI: 6,9, 17,4).
English: The pharmacokinetics of midazolam (sensitive CYP3A4 probe) were not affected following three days' dosing of midostaurin in healthy subjects.
Danish: Midazolams farmakokinetik (følsom CYP3A4-probe) blev ikke påvirket efter tre dages dosering af midostaurin hos raske forsøgspersoner.
English: Based on population pharmacokinetic analyses no significant impact of age on the pharmacokinetics of midostaurin and its two active metabolites was identified for patients aged between 65 and 85 years.
Danish: På basis af populationsfarmakokinetiske analyser blev der ikke identificeret nogen signifikant indvirkning af alder på farmakokinetikken af midostaurin og dets to aktive metabolitter hos patienter i alderen 65-85 år.
English: Of these, 73 patients had ASM (57 with an AHN) and 16 patients had MCL (6 with an AHN).
Danish: Af disse havde 73 patienter ASM (57 med AHN), og 16 patienter havde mastcelleleukæmi (6 med AHN).
English: Based on an interim analysis, the EFS rate at 2 years (primary endpoint) was 27.1% (95% CI: 16.6, 44.1) and the median OS was 15.5 months in patients older than 60 years of age (46 out of 145 patients).
Danish: Baseret på en interimanalyse var EFS-satsen på 2. år (primært endepunkt) 27,1 % (95 % CI: 16,6, 44,1), og median OS var 15,5 måneder hos patienter over 60 år (46 ud af 145 patienter).
English: Disease Free Survival (DFS)
Danish: Sygdomsfri overlevelse (DFS)
English: The study demonstrated a statistically significant improvement in OS with a 23% risk reduction of death for midostaurin plus standard chemotherapy over placebo plus standard chemotherapy (see Table 6 and Figure 1).
Danish: I studiet blev der påvist en statistisk signifikant forbedring i OS med en reduktion i risikoen for dødsfald på 23 % for midostaurin plus standardkemoterapi sammenlignet med placebo plus standardkemoterapi (se tabel 6 og figur 1).
English: MIDOSTAURIN - SCT PLACEBO - SCT MIDOSTAURIN - no SCT PLACEBO - no SCT
Danish: MIDOSTAURIN - SCT PLACEBO - SCT MIDOSTAURIN - ingen SCT PLACEBO - ingen SCT
English: Event Free Survival (EFS)
Danish: Hændelsesfri overlevelse (EFS)
English: Discontinue Rydapt if toxicity is not resolved to Grade ≤2 within 21 days or severe toxicity recurs at a reduced dose of Rydapt.
Danish: Afbryd doseringen af Rydapt, hvis toksiciteten ikke er svundet ind til grad ≤2 inden for 21 dage, eller når svær toksicitet ses igen ved en lavere dosis af Rydapt.
English: In addition, in patients who achieved complete remission during induction, the cumulative incidence of relapse at 12 months was 26% in the midostaurin arm versus 41% in the placebo arm.
Danish: Derudover var den kumulative incidens af recidiv ved 12 måneder hos patienter, der opnåede komplet remission under induktionen, 26 % i midostaurin-armen versus 41 % i placebo-armen.
English: Based on a phase I study in healthy Japanese volunteers, pharmacokinetic profiles of midostaurin and its metabolites (CGP62221 and CGP52421) are similar compared to those observed in other pharmacokinetic studies conducted in Caucasians and Blacks.
Danish: På basis af et fase I-studie hos raske japanske frivillige er de farmakokinetiske profiler af midostaurin og dets metabolitter (CGP62221 og CGP52421) omtrent ens sammenlignet med de profiler, der er set i andre farmakokinetiske studier udført hos kaukasere og sorte.
English: Patients who received non-study anti-neoplastic therapy were considered as having progressed at the time of the new therapy.
Danish: Patienter, der fik anti-neoplastisk terapi som ikke var en del af studiet, blev betragtet som progredierede på tidspunktet for den nye behandling.
English: The two major human metabolites GGP52421 and CGP62221 (also tested at the limit of solubility) inhibited hERG current with moderate safety margins.
Danish: De to hovedmetabolitter hos mennesker, CGP52421 og CGP62221 (også testet ved opløselighedsgrænsen), hæmmede hERG-strømmen med en moderat sikkerhedsmargen.
English: The most frequent (incidence ≥1%) were febrile neutropenia, nausea, vomiting and pleural effusion.
Danish: De hyppigste (incidens ≥1 %) var febril neutropeni, kvalme, opkastning og pleuraekssudat.
English: Amylase increased*
Danish: Forhøjet amylaseniveau*
English: Resume Rydapt at the initial dose in the next cycle provided that QTc interval improves to ≤470 msecs at the start of that cycle.
Danish: Genoptag den initiale dosering af Rydapt i den næste cyklus, forudsat at QTc-intervallet forbedres til ≤470 ms i starten af denne cyklus.
English: The median age was 64.5 years with half of the patients ≥65 years).
Danish: Medianalderen var 64,5 år med halvdelen af patienterne ≥65 år.
English: At the start of treatment in AML Rydapt is always used together with chemotherapy (medicines for treating cancer).
Danish: Ved AML anvendes Rydapt altid sammen med kemoterapi (lægemidler til behandling af kræft) i starten af behandling.
English: Total bilirubin increased*
Danish: Forhøjet totalbilirubin-niveau*
English: Median DFS in months (95% CI) 26.7 (19.4, NE) 15.5 (11.3, 23.5) 0.71 (0.55, 0.92) 0.0051 Complete Remission (CR) within 60 days of treatment start
Danish: Median DFS i måneder (95 % CI) 26,7 (19,4, NE) 15,5 (11,3, 23,5) 0,71 (0,55, 0,92) 0,0051 Komplet remission (CR) inden for 60 dage efter behandlingsstart (%)
English: Table 3 presents the frequency category of ADRs reported in the phase III study in patients with newly diagnosed FLT3-mutated AML.
Danish: Tabel 3 viser hyppighedskategorien af bivirkninger rapporteret i fase III-studiet hos patienter med nydiagnosticeret FLT3-muteret AML.
English: However, CGP52421 concentrations increased up to 2.5-fold for ASM, SM-AHN and MCL and up to 9-fold for AML, compared to midostaurin after one month of treatment.
Danish: Der var dog en øgning af koncentrationen af CGP52421 på op til 2,5 gange for ASM, SM-AHN og mastcelleleukæmi og op til 9 gange for AML sammenlignet med midostaurin efter én måneds behandling.
English: Alcohol may be harmful if you have alcohol-related problems, epilepsy or liver problems, or if you are pregnant or breast-feeding.
Danish: Alkohol kan have en skadelig virkning, hvis du har alkoholrelaterede problemer, epilepsi eller leverproblemer, eller hvis du er gravid eller ammer.
English: In patients receiving a haematopoietic stem cell transplant (SCT), Rydapt should be discontinued 48 hours prior to the conditioning regimen for SCT.
Danish: Hos patienter, der skal have en hæmatopoietisk stamcelletransplantation (SCT), bør Rydapt seponeres 48 timer forud for konditioneringsregimet for SCT.
English: Skin and subcutaneous tissue disorders Dermatitis exfoliative
Danish: Hud og subkutane væv Exfoliativ dermatitis
English: Rydapt is used to treat acute myeloid leukaemia (AML) in adults who have a defect in a gene called FLT3.
Danish: Rydapt anvendes til behandling af akut myeloid leukæmi (AML) hos voksne, der har en fejl i et gen, som kaldes FLT3.
English: Platelet count less than 50 x 10
Danish: Trombocyttal på mindre end 50 x 10
English: Table 3 Adverse drug reactions observed in the AML clinical study
Danish: Tabel 3 Bivirkninger observeret i det kliniske AML-studie
English: Dose modifications in AML Recommendations for dose modifications of Rydapt in patients with AML are provided in Table 1.
Danish: Dosisændringer ved AML Anbefalinger til dosismodifikation for Rydapt hos patienter med AML er angivet i tabel 1.
English: In the ASM, SM-AHN and MCL studies cardiac dysfunction such as congestive heart failure (CHF) (including some fatalities) and transient decreases in left ventricular ejection fraction (LVEF) occurred.
Danish: I studierne af ASM, SM-AHN og mastcelleleukæmi forekom der kardial dysfunktion, fx kronisk hjerteinsufficiens (CHF) (herunder nogle dødsfald) og forbigående fald i venstre ventrikels uddrivningsfraktion (LVEF).
English: Soft capsule (capsule).
Danish: Kapsel, blød (kapsel).
English: Decrease Rydapt to 50 mg once daily for the remainder of the cycle.
Danish: Nedsæt doseringen af Rydapt til 50 mg en gang daglig i resten af cyklussen.
English: Patients should be monitored for pulmonary symptoms indicative of ILD or pneumonitis and Rydapt discontinued in patients who experience pulmonary symptoms indicative of ILD or pneumonitis that are ≥Grade 3 (NCI CTCAE).
Danish: Patienterne bør monitoreres for lungesymptomer, som er tegn på ILD eller pneumonitis, og Rydapt bør seponeres hos patienter, der oplever lungesymptomer, som er tegn ≥grad 3 ILD eller pneumonitis (NCI CTCAE).
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne angivet efter, hvor alvorlige de er.
English: Kaplan-Meier estimates at 5 years (95% CI)
Danish: Kaplan-Meier-estimater efter 5 år (95 % CI)
English: While Table 3 provides the incidence for ADRs over the total duration of the study, when the maintenance phase (single agent Rydapt or placebo) was assessed separately, a difference in the type and severity of ADRs was observed.
Danish: Selvom tabel 3 viser incidensen for bivirkninger over den samlede varighed af studiet, blev der observeret en forskel i typen og sværhedsgraden af bivirkninger, når vedligeholdelsesfasen (Rydapt eller placebo som enkeltstof) blev vurderet særskilt.
English: Interstitial lung disease (ILD) and pneumonitis, in some cases fatal, have occurred in patients treated with Rydapt monotherapy or in combination with chemotherapy.
Danish: Interstitiel lungesygdom (ILD) og pneumonitis, i nogle tilfælde med dødelig udgang, er forekommet hos patienter, der blev behandlet med Rydapt som monoterapi eller i kombination med kemoterapi.
English: Cmin of CGP52421 was increased by 1.3-fold, whereas no significant effect in exposure of CGP62221 was observed (see section 4.4).
Danish: Cmin for CGP52421 var øget med 1,3 gange, men der blev ikke observeret en signifikant effekt på eksponeringen for CGP62221 (se pkt.
English: Rydapt contains ethanol anhydrous (alcohol)
Danish: Rydapt indeholder vandfri ethanol (alkohol)
English: 1-sided p-value calculated using log-rank test stratified according to the randomisation FLT3 mutation factor.
Danish: 1-sidet p-værdi beregnet ved brug af log rank-test stratificeret i henhold til FLT3-mutationrandomiseringsfaktoren.
English: The pivotal study was a multicentre, single-arm phase II study in 116 patients with advanced SM (Study CPKC412D2201).
Danish: Det centrale studie var et fase II-multicenterstudie med en enkelt arm, der omfattede 116 patienter med fremskreden SM (studie CPKC412D2201).
English: The majority of patients (77.4%) had FLT3-ITD mutations, most of them (47.6%) with a low allelic ratio (<0.7), and 22.6% of patients had FLT3-TKD mutations.
Danish: De fleste patienter (77,4 %) havde FLT3-ITD-mutationer, hvoraf de fleste (47,6 %) havde et lavt allelforhold (<0,7) og 22,6 % af patienterne havde FLT3-TKD-mutationer.
English: The safety evaluation of Rydapt (50 mg twice daily) in patients with newly diagnosed FLT3-mutated AML is based on a phase III, randomised, double-blind, placebo-controlled study with 717 patients.
Danish: Sikkerhedsvurderingen af Rydapt (50 mg to gange daglig) hos patienter med nydiagnosticeret FLT3muteret AML er baseret på et randomiseret, dobbeltblindet, placebokontrolleret fase III-studie med 717 patienter.
English: In the repeat-dose studies in dogs, a decrease in heart rate, prolongation of the P-Q interval, and sporadically occurring atrioventricular blocks were seen in individual animals.
Danish: I studierne med gentagne doser hos hunde blev der set et fald i hjertefrekvensen, en forlængelse af PQ-intervallet og sporadisk forekommende atrioventrikulær blokade hos enkelte dyr.
English: Out of the 321 patients included, 177 patients showed pre-existing mild (n=113), moderate (n=60) or severe (n=4) renal impairment (15 ml/min ≤ creatinine clearance [CrCL] <90 ml/min).
Danish: Ud af de 321 inkluderede patienter havde 177 patienter eksisterende let nedsat (n=113), moderat nedsat (n=60) eller svært nedsat (n=4) nyrefunktion (15 ml/min ≤ kreatininclearance [CrCL] <90 ml/min).
English: Following multiple doses, the pharmacokinetics of midostaurin and CGP62221 were time-dependent, with an initial increase observed in the first week followed by a decline of concentrations until reaching steady state on day 28.
Danish: Efter flere doser var farmakokinetikken af midostaurin og CGP62221 tidsafhængig med en indledende stigning observeret i den første uge efterfulgt af et fald i koncentrationerne, indtil steady state blev nået på dag 28.
English: ASM, SM-AHN and MCL The recommended starting dose of Rydapt is 100 mg orally twice daily.
Danish: ASM, SM-AHN og mastcelleleukæmi Den anbefalede startdosis af Rydapt er 100 mg oralt to gange daglig.
English: It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Danish: På nuværende tidspunkt vides det ikke, om midostaurin kan nedsætte effektiviteten af hormonelle kontraceptiva og derfor bør kvinder, der anvender hormonelle kontraceptiva, tilføje en svangerskabsforebyggende barrieremetode.
English: No midostaurin dose adjustment is required based on ethnicity.
Danish: Det er ikke påkrævet at justere midostaurin-dosis på basis af etnicitet.
English: Rydapt contains about 14 vol. % ethanol anhydrous, which corresponds to up to 333 mg alcohol per dose.
Danish: Rydapt indeholder omkring 14 vol. % vandfri ethanol, dvs. op til 333 mg alkohol pr. dosis.
English: Midostaurin is metabolised by CYP3A4 mainly via oxidative pathways.
Danish: Midostaurin metaboliseres via CYP3A4 og primært ved oxidation.
English: The effect on the bone marrow and lymphoid organs was accompanied by haematological changes of decreased white blood cells, lymphocytes and erythrocytic parameters.
Danish: Virkningen på knoglemarven og lymfeorganerne var ledsaget af hæmatologiske ændringer i form af fald i niveauet af hvide blodceller, lymfocytter og erytrocytparametre.
English: Midostaurin undergoes extensive hepatic metabolism mainly through CYP3A4 enzymes which are either induced or inhibited by a number of concomitant medicinal products.
Danish: Midostaurin gennemgår omfattende metabolisme i leveren hovedsageligt via CYP3A4-enzymer, som enten kan induceres eller hæmmes af en række lægemidler, hvis disse gives samtidig.
English: If you have any questions about how Rydapt works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Danish: Hvis du har spørgsmål til, hvordan Rydapt virker, eller hvorfor dette lægemiddel er blevet ordineret til dig, så tal med lægen, apotekspersonalet eller sundhedspersonalet.
English: Disturbance in attention
Danish: Opmærksomhedsforstyrrelse
English: In healthy subjects, midostaurin absorption (AUC) was increased by an average of 22% when Rydapt was co-administered with a standard meal and by an average of 59% when co-administered with a high-fat meal.
Danish: Hos raske forsøgspersoner blev absorptionen af midostaurin (AUC) øget med gennemsnitligt 22 %, når Rydapt blev administreret samtidig med et standardmåltid, og med gennemsnitligt 59 % ved samtidig administration med et fedtholdigt måltid.
English: Environmental risk assessment studies have shown that midostaurin has the potential to be persistent, bioaccumulative and toxic to the environment.
Danish: Miljørisikovurderingsstudier har vist, at midostaurin kan ophobes og findes i lang tid i miljøet samt være giftigt for miljøet.
English: Table 8 Efficacy of midostaurin in ASM, SM-AHN and MCL per IWG-MRT-ECNM consensus criteria using an algorithmic approach
Danish: Tabel 8 Virkning af midostaurin ved ASM, SM-AHN og mastcelleleukæmi (MCL) pr. IWGMRT-ECNM konsensuskriterier ved anvendelse af en algoritmisk tilgang
English: ADRs reported during the maintenance phase led to discontinuation of 1.2% of patients in the Rydapt arm and none in the placebo arm.
Danish: Bivirkninger rapporteret i vedligeholdelsesfasen førte til seponering af 1,2 % af patienterne i Rydaptarmen og ingen af patienterne i placebo-armen.
English: While the study included patients with various AML-related cytogenetic abnormalities, patients with acute promyelocytic leukaemia (M3) or therapy-related AML were excluded.
Danish: Selvom patienter med forskellige AML-relaterede cytogenetiske anomalier blev inkluderet i studiet, blev patienter med akut promyelocyt leukæmi (M3) eller behandlingsrelateret AML udelukket.
English: The median terminal half-lives of midostaurin, CGP62221 and CGP52421 in plasma are approximately 20.9, 32.3 and 471 hours.
Danish: Medianen af de terminale halveringstider af midostaurin, CGP62221 og CGP52421 i plasma er ca. 20,9, 32,3 og 471 timer.
English: Patients who proceeded to haematopoietic stem cell transplant (SCT) stopped receiving study treatment prior to the start of the SCT conditioning regimen.
Danish: Patienter, der gik videre med hæmatopoietisk stamcelletransplantation (SCT), ophørte med at modtage forsøgsbehandling forud for opstart på konditioneringsregimet for SCT.
English: Discontinuation due to any adverse reaction occurred in 3.1% of patients in the Rydapt arm versus 1.3% in the placebo arm.
Danish: Seponering som følge af en hvilken som helst bivirkning forekom hos 3,1 % af patienterne i Rydaptarmen versus 1,3 % i placebo-armen.
English: Twenty (76.9%) patients had ASM (17 [85%] with AHN) and 6 patients (23.1%) had MCL (2 [33.3%] with AHN).
Danish: Tyve (76,9 %) patienter havde ASM (17 [85 %] med AHN), og 6 patienter (23,1 %) havde mastcelleleukæmi (2 [33,3 %] med AHN).
English: Overall, there was no clinically relevant increase in exposure (AUC) to plasma midostaurin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function.
Danish: Samlet set var der ingen klinisk relevant øgning i eksponering (AUC) for plasma-midostaurin hos forsøgspersoner med let eller moderat nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.
English: EFS (CR induction) (HR)
Danish: EFS (CR induktion) (HR)
English: Based on the population pharmacokinetic analyses, midostaurin clearance was not significantly impacted by renal impairment and therefore no dosage adjustment is necessary for patients with mild or moderate renal impairment.
Danish: På basis af de populationsfarmakokinetiske analyser blev clearancen af midostaurin ikke signifikant påvirket af nedsat nyrefunktion, og derfor er det ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat nyrefunktion.
English: Effect of other medicinal products on Rydapt
Danish: Andre lægemidlers indvirkning på Rydapt
English: In adult patients with ASM, SM-AHN and MCL or AML, no midostaurin dose adjustment is required based on age.
Danish: Hos voksne patienter med ASM, SM-AHN og mastcelleleukæmi eller AML er det ikke påkrævet at justere midostaurin-dosis på basis af alder.
English: Catheter-related thrombosis
Danish: Kateter-relateret trombose
English: Interrupt Rydapt for the remainder of the cycle.
Danish: Afbryd doseringen af Rydapt i den resterende del af cyklus.
English: The most frequent ADRs that led to dose modification (incidence ≥5%) were nausea and vomiting.
Danish: De hyppigste bivirkninger, der førte til dosisændring (incidens ≥5 %), var kvalme og opkastning.
English: Rydapt is not recommended during pregnancy or in women of childbearing potential not using contraception.
Danish: Rydapt bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In a fertility study in rats, midostaurin was associated with reduced fertility, testicular degeneration and atrophy, reduced sperm motility, oligo- and aspermia, increased resorptions, decreased pregnancy rate, number of implants and live embryos.
Danish: I et fertilitetsstudie med rotter, blev midostaurin associeret med nedsat fertilitet, degeneration og atrofi af testiklerne, reduceret sædmotilitet, oligo- og aspermi, øget forekomst af resorptioner, nedsat graviditetsrate og nedsat antal implanteringer og levende fostre.
English: A 100 mg dose of Rydapt contains approximately 14 vol. % ethanol anhydrous, which corresponds to 333 mg alcohol.
Danish: En 100 mg dosis Rydapt indeholder ca. 14 vol. % ethanol, vandfri, hvilket svarer til 333 mg alkohol.
English: A reduction in body weight, haemorrhage and mixed cell infiltration in the lungs, and erythrocytosis/erythrophagocytosis in the mesenteric lymph nodes were seen.
Danish: Der blev set en reduktion i legemsvægten, blødning og blandet-celle-infiltration i lungerne og erytrocytose/erytrofagocytose i de mesenteriale lymfeknuder.
English: Rydapt should be discontinued in patients who develop recurrent or prolonged severe neutropenia that is suspected to be related to Rydapt (see section 4.2).
Danish: Rydapt bør seponeres hos patienter, der udvikler tilbagevendende eller længerevarende svær neutropeni, som formodes at være relateret til Rydapt (se pkt.
English: Activated partial thromboplastin time prolonged
Danish: Forlængelse af aktiveret partiel tromboplastintid
English: Metabolism and nutrition disorders Hyperuricaemia
Danish: Metabolisme og ernæring Hyperurikæmi
English: Reproductive studies in rats and rabbits demonstrated that midostaurin induced foetotoxicity (see section 5.3).
Danish: Reproduktionsstudier hos rotter og kaniner viste, at midostaurin inducerede føtotoksicitet (se pkt.
English: In proliferation assays with FLT3-ITD expressing cells, CGP62221 showed similar potency compared to the parent compound, however CGP52421 was approximately 10-fold less potent.
Danish: I proliferationsanalyser med FLT3-ITD-udtrykkende celler viste CGP62221 en potens, der var omtrent den samme sammenlignet med det oprindelige stof; men CGP52421 var ca. 10 gange mindre potent.
English: Rydapt is not recommended to be used in children and adolescents (see section 4.2).
Danish: Det anbefales ikke at anvende Rydapt til børn og unge (se pkt.
English: Ear and labyrinth disorders Vertigo
Danish: Øre og labyrint Vertigo
English: The capsules are provided in blisters and are available in packs containing 56 capsules (2 packs of 28 capsules) or 112 capsules (4 packs of 28 capsules).
Danish: Kapslerne fås i blistre og er tilgængelige i pakninger med 56 kapsler (2 pakninger med 28 kapsler) eller 112 kapsler (4 pakninger med 28 kapsler).