FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of Rydapt with strong inducers of CYP3A4 (e.g. carbamazepine, rifampicin, enzalutamide, phenytoin, St. John's Wort [Hypericum perforatum]) is contraindicated (see section 4.3).
Danish: Samtidig anvendelse af Rydapt og potente CYP3A4-induktorer (fx carbamazepin, rifampicin, enzalutamid, phenytoin, prikbladet perikon [Hypericum perforatum]) er kontraindiceret (se pkt.
English: Overall response rate, n (%) (95% CI)
Danish: Samlet responsrate, n (%) (95 % CI)
English: Infections and infestations Device-related infection
Danish: Infektioner og parasitære sygdomme Infektion relateret til administrationssystem
English: Some side effects in patients with AML could be serious.
Danish: Andre bivirkninger hos patienter med AML
English: PAES: In order to investigate the efficacy in elderly patients, the MAH should conduct and submit the results of A2408, a study to assess the efficacy and safety of midostaurin in combination with standard chemotherapy during induction and consolidation, followed by 12 months of midostaurin monotherapy in adult patients (aged ≥18 years) with newly diagnosed FLT3-mutated AML.
Danish: PAES: For at undersøge effekten hos ældre patienter, skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne af A2408; et studie, der evaluerer effekten og sikkerheden af midostaurin i kombination med standard kemoterapi under induktion og konsolidering, efterfulgt af 12 måneders midostaurin monoterapi hos voksne patienter (≥18 år) med nydiagnosticeret, FLT3muteret AML.
English: 112 (4 packs of 28) capsules
Danish: 112 (4 pakninger med 28) kapsler
English: AST increased*
Danish: Forhøjet ALAT-niveau*
English: No study has been completed in patients with severe (Child-Pugh C) hepatic impairment (see section 4.4).
Danish: Der er ikke gennemført studier hos patienter med svært nedsat (Child-Pugh C) leverfunktion (se pkt.
English: No dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let eller moderat nedsat leverfunktion ved baseline.
English: You should not breast-feed during treatment with Rydapt and for at least 4 months after stopping the treatment.
Danish: Du bør ikke amme under behandling med Rydapt og i mindst 4 måneder efter behandlingsophør.
English: Other medicines and Rydapt
Danish: Brug af anden medicin sammen med Rydapt
English: Females 95% CI
Danish: Kvinder 95% CI
English: 56 (2 packs of 28) capsules
Danish: 56 (2 pakninger med 28) kapsler
English: The most frequent adverse drug reactions (ADRs) in the Rydapt arm were febrile neutropenia (83.4%), nausea (83.4%), exfoliative dermatitis (61.6%), vomiting (60.7%), headache (45.9%), petechiae (35.8%) and pyrexia (34.5%).
Danish: De hyppigste bivirkninger i Rydapt-armen var febril neutropeni (83,4 %), kvalme (83,4 %), eksfoliativ dermatitis (61,6 %), opkastning (60,7 %), hovedpine (45,9 %), petekkier (35,8 %) og pyreksi (34,5 %).
English: No dedicated renal impairment study was conducted for midostaurin.
Danish: Der blev ikke udført dedikerede studier med midostaurin ved nedsat nyrefunktion.
English: Caution is warranted when considering the administration of midostaurin in patients with severe renal impairment or end-stage renal disease and patients should be carefully monitored for toxicity (see section 5.2).
Danish: Der skal udvises forsigtighed, når det overvejes, om midostaurin skal administreres til patienter med alvorlig nedsat nyrefunktion eller nyresvigt, og patienterne bør overvåges nøje for tegn på toksicitet (se pkt.
English: primary endpoint;
Danish: Primært endepunkt.
English: The most frequent Grade 3/4 laboratory abnormalities were absolute lymphocyte count decreased (45.8%), ANC decreased (26.8%), hyperglycaemia (19%), and lipase increased (17.6%).
Danish: De hyppigste laboratorieanomalier af grad 3/4 var fald i absolut lymfocyttal (45,8 %), fald i ANC (26,8 %), hyperglykæmi (19 %) og forhøjet lipase-niveau (17,6 %).
English: In addition, a time-dependent inhibition of CYP3A4 by midostaurin, CGP52421 and CGP62221 was also observed in vitro.
Danish: In vitro ses der desuden også en tidsafhængig hæmning af CYP3A4 med midostaurin, CGP52421 og CGP62221.
English: Midostaurin (n=360) Median: 74.7 months Placebo (n=357) Median: 25.6 months HR: 0.774 (95% CI, 0.629-0.953) P = 0.0078
Danish: Median: 25,6 måneder HR: 0,774 (95 % CI, 0,629-0,953) P = 0,0078
English: Enzyme drug-drug interactions
Danish: Enzym-lægemiddel-lægemiddel-interaktioner
English: The most frequent laboratory abnormalities were haemoglobin decreased (97.3%), ANC decreased (86.7%), ALT increased (84.2%), AST increased (73.9%) and hypokalaemia (61.7%).
Danish: De hyppigste laboratorieanomalier var fald i hæmoglobin-niveau (97,3 %), fald i ANC (86,7 %), forhøjet ALAT (84,2 %), forhøjet ASAT (73,9 %) og hypokaliæmi (61,7 %).
English: They should not be opened, crushed or chewed to ensure proper dosing and avoid the unpleasant taste of the capsule content.
Danish: For at sikre korrekt dosering og undgå ubehagelig smag af kapselindholdet, bør kapslerne ikke åbnes, knuses eller tygges.
English: The most frequent Grade 3/4 ADRs were febrile neutropenia (83.5%), lymphopenia (20.0%), device-related infection (15.7%), exfoliative dermatitis (13.6%), hyperglycaemia (7.0%) and nausea (5.8%).
Danish: De hyppigste grad 3/4 bivirkninger var febril neutropeni (83,5 %), lymfopeni (20,0 %), infektion relateret til administrationssystem (15,7 %), eksfoliativ dermatitis (13,6 %), hyperglykæmi (7,0 %) og kvalme (5,8 %).
English: Rydapt 25 mg capsules midostaurin
Danish: Rydapt 25 mg kapsler midostaurin
English: known as hyperglycaemia) - yellow skin and eyes (sign of high bilirubin in the blood) - abnormal blood test results which indicate possible problems with the pancreas (high levels of lipase or amylase) and liver (high levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST))
Danish: kendt som hypokaliæmi) - blå mærker og blødning (blodet har problemer med at størkne) - unormale blodprøveresultater, hvilket kan fortælle lægen, hvor godt bestemte dele af din krop fungerer: højt niveau af alaninaminotransferase (ALAT) og/eller aspartataminotransferase
English: Contains macrogolglycerol hydroxystearate and ethanol anhydrous.
Danish: Indeholder ricinusolie, polyoxyleret, hydrogeneret og vandfri ethanol.
English: 56 (2 packs of 28) capsules 112 (4 packs of 28) capsules
Danish: 56 (2 pakninger med 28) kapsler 112 (4 pakninger med 28) kapsler
English: An increased frequency of QTc prolongation was noted in midostaurin-treated patients (see section 4.8), however, a mechanistic explanation for this observation was not found.
Danish: En øget hyppighed af QTc-forlængelse blev set hos patienter, som blev behandlet med midostaurin (se pkt.
English: Primary endpoint Overall response, n (%) (95% CI)
Danish: Primært endepunkt Samlet respons, n (%) (95 % Cl)
English: Recommendations for dose modifications of Rydapt in patients with ASM, SM-AHN and MCL are provided in Table 2.
Danish: Dosisændringer ved ASM, SM-AHN og mastcelleleukæmi Anbefalinger til dosismodifikation for Rydapt hos patienter med ASM, SM-AHN og mastcelleleukæmi er angivet i tabel 2.
English: After 100 mg bid multiple oral doses of midostaurin the Cmin,ss plasma midostaurin in AML and ASM, SMAHN, MCL patients were 919 and 1060 ng/ml, respectively.
Danish: Efter gentagen administration af 100 mg to gange daglig af midostaurin var Cmin,ss plasmamidostaurin hos AML- og ASM-, SM-AHN-, mastcelleleukæmipatienter henholdsvis 919 og 1060 ng/ml.
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are considered inhibitors and may potentially cause increases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5.
Danish: På basis af in vitro-data anses midostaurin og dets aktive metabolitter, CGP52421 og CGP62221, for at være hæmmere og kan potentielt forårsage øgninger i eksponeringen for samtidigt administrerede lægemidler, der primært elimineres via CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 og CYP3A4/5.
English: Tell your doctor, pharmacist or nurse straight away if you notice any of the following: - weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills,
Danish: Nogle bivirkninger hos patienter med AML kan være alvorlige Fortæl det straks til lægen eller sygeplejersken, hvis du bemærker noget af følgende: - svaghed, spontan blødning eller blå mærker, hyppige infektioner med tegn som fx feber,
English: Anorectal discomfort
Danish: Anorektale gener
English: Subjects
Danish: Indhold
English: The safety of Rydapt (100 mg twice daily) as a single agent in patients with ASM, SM-AHN and MCL was evaluated in 142 patients in two single-arm, open-label, multicentre studies.
Danish: Sikkerheden af Rydapt (100 mg to gange daglig) som enkeltstof hos patienter med ASM, SM-AHN og mastcelleleukæmi blev vurderet hos 142 patienter i to ublindede multicenterstudier med en enkelt arm. Medianvarigheden af eksponering for Rydapt var 11,4 måneder (interval: 0-81 måneder).
English: Maintenance only Grade 4 neutropenia (ANC <0.5 x 10
Danish: Grad 4 neutropeni (ANC <0,5 x 10
English: Based on in vitro data, midostaurin and its active metabolites, CGP52421 and CGP62221, are also considered inducers and may cause decreases in exposure of co-administered medicinal products primarily cleared by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 (see section 4.5).
Danish: På basis af in vitro-data anses midostaurin og dets aktive metabolitter, CGP52421 og CGP62221, også for at være induktorer og kan forårsage reduktioner i eksponeringen for samtidigt administrerede lægemidler, der primært elimineres via CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP3A4/5 (se pkt.
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to inhibit CYP1A2, CYP2D6, CYP2C8, CYP2C9, CYP2E1 and CYP3A4/5 enzymes.
Danish: In vitro-data viser, at midostaurin og/eller dets metabolitter har potentiale til at hæmme CYP1A2-, CYP2D6-, CYP2C8-, CYP2C9-, CYP2E1- og CYP3A4/5-enzymer.
English: Based on in vitro data, midostaurin and/or its metabolites have the potential to induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP3A4/5 enzymes.
Danish: Ifølge in vitro-data kan midostaurin og/eller dets metabolitter inducere CYP1A2-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19 og CYP3A4/5-enzymer.
English: Cardiac disorders Hypotension
Danish: Hjerte Hypotension
English: Common (may affect up to 1 in every 10 people) - upper respiratory tract infection - nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching (signs of high levels of calcium in the blood, known as hypercalcaemia) - fainting - involuntary shaking of the body - headache, dizziness (high blood pressure) - fast heart beat (sinus tachycardia) - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - fluid collection in the lungs/chest cavity, which, if severe, could make you breathless (pleural effusion) - sore throat and a runny nose - swelling of the eyelid - discomfort in the anus and rectum - abdominal pain, nausea, vomiting, constipation (abdominal discomfort) - dry skin - eye pain, blurred vision, intolerance to light (keratitis) - neck pain - bone pain - pain in limbs - increased weight - blood clotted in the catheter - abnormal blood test results which can indicate to your doctor how well certain parts of your body are functioning: high levels of uric acid
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter) - infektion i øvre luftveje - kvalme, opkastning, forstoppelse, mavesmerter, hyppig vandladning, tørst, muskelsvaghed og muskeltrækninger (tegn på højt niveau af calcium i blodet, kendt som hypercalcæmi) - besvimelse - ufrivillige rystelser af kroppen - hovedpine, svimmelhed (højt blodtryk) - høj puls (sinustakykardi) - væskeansamling omkring hjertet, hvilket i alvorlig grad kan nedsætte hjertets evne til at pumpe blodet rundt (perikardieekssudat) - væskeansamling i lungerne/brystkassens hulrum, hvilket, hvis det er alvorligt, kan gøre dig stakåndet (pleuraekssudat) - ondt i halsen og løbende næse - hævelse af øjenlåget - ubehag ved endetarmsåbningen og endetarmen - mavesmerter, kvalme, opkastning, forstoppelse (mavebesvær) - tør hud - øjensmerter, sløret syn, lysfølsomhed (hornhindebetændelse) - nakkesmerter - knoglesmerter - smerter i arme og ben - tage på i vægt - størknet blod i kateter - unormale blodprøveresultater, hvilket kan fortælle lægen, hvor godt bestemte dele af din krop fungerer: højt niveau af urinsyre
English: Discontinue Rydapt if low ANC persists for >21 days and is suspected to be related to Rydapt.
Danish: Afbryd doseringen af Rydapt hvis der i >21 dage ses vedvarende lav ANC, som formodes at være relateret til Rydapt.
English: Abdominal discomfort
Danish: Abdominale gener
English: Interrupt Rydapt until platelet count greater than or equal to 50 x 10
Danish: Afbryd doseringen af Rydapt, indtil trombocyttallet er på 50 x 10
English: Best overall response, n (%) Complete remission Partial remission Clinical improvement Duration of response* n/N (%) median (95% CI)
Danish: Stabil sygdom, n (%) Progredierende sygdom, n (%) Sekundære endepunkter Medianvarighed af respons, måneder (95 % CI)
English: confusion and extreme tiredness (signs of acute respiratory distress syndrome) - infections, fever, low blood pressure, decreased urination, rapid pulse, rapid breathing (signs of sepsis or neutropenic sepsis)
Danish: kulderystelser, ondt i halsen eller mundsår (tegn på et lavt niveau af blodceller) - voldsom åndenød, besværet og unormalt hurtig vejrtrækning, svimmelhed, ørhed forvirring og ekstrem træthed (tegn på akut lungesvigt) - infektioner, feber, lavt blodtryk, nedsat vandladning, høj puls, hurtig vejrtrækning (tegn på blodforgiftning eller neutropen blodforgiftning)
English: If QTc improves to ≤470 msecs just prior to the next cycle, resume Rydapt at the initial dose.
Danish: Genoptag behandlingen med den initiale dosis af Rydapt, hvis QTc forbedres til ≤470 ms lige før den næste cyklus.
English: The most frequent Grade 3/4 laboratory abnormalities were ANC decreased (85.8%), haemoglobin decreased (78.5%), ALT increased (19.4%) and hypokalaemia
Danish: De hyppigste laboratorieanomalier af grad 3/4 var fald i ANC (85,8 %), fald i hæmoglobin-niveau (78,5 %), forhøjet ALAT (19,4 %) og hypokaliæmi (13,9 %).
English: Rydapt 25 mg soft capsules midostaurin
Danish: Rydapt 25 mg bløde kapsler midostaurin
English: ASM, SM-AHN and MCL
Danish: ASM, SM-AHN og mastcelleleukæmi
English: Males 95% CI
Danish: Ialt 95% CI
English: Petechiae
Danish: Petekkier
English: General disorders and administration site conditions Oedema peripheral
Danish: Almene symptomer og reaktioner på administrationsstedet Perifert ødem
English: - If you are being treated for AML, after you finish taking Rydapt with chemotherapy medicines,
Danish: hvor du stopper med at tage Rydapt med kemoterapi.
English: Common (may affect up to 1 in every 10 people) - involuntary shaking of the body - cough with phlegm, chest pain, fever (bronchitis) - cold sores in the mouth due to viral infection (oral herpes) - painful and frequent urination (cystitis) - feeling of pressure or pain in the cheeks and forehead (sinusitis) - red, swollen painful rash on any part of the skin (erysipelas) - shingles (herpes zoster) - disturbance in attention - feeling dizzy with spinning sensation (vertigo) - bruising (haematoma) - upset stomach, indigestion - feeling weak (asthenia) - chills - generalised swelling (oedema) - increased weight - contusion (bruises) - falls - dizziness, light-headedness (low blood pressure) - sore throat
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer) - ufrivillige rystelser af kroppen - hoste med slim, smerter i brystet, feber (bronkitis) - forkølelsessår i munden på grund af virusinfektion (oral herpes) - smertefuld og hyppig vandladning (blærebetændelse) - tryk eller smerter i kinderne og panden (bihulebetændelse) - rødt, hævet, smertefuldt udslæt et vilkårligt sted på huden (rosen) - helvedesild (herpes zoster) - opmærksomhedsforstyrrelse - svimmelhed med en snurrende fornemmelse (vertigo) - blå mærker (hæmatomer) - irriteret mave, fordøjelsesbesvær - svaghed (asteni) - kulderystelser - generaliseret hævelse (ødem) - vægtstigning
English: Discontinue Rydapt if low haemoglobin persists for >21 days and is suspected to be related to Rydapt.
Danish: Afbryd doseringen af Rydapt, hvis der i >21 dage ses vedvarende lave hæmoglobinværdier, som formodes at være relateret til Rydapt.
English: HR (95% CI)
Danish: HR (95 % Cl)
English: If you take more Rydapt than you should
Danish: Hvis du har taget for meget Rydapt
English: Rydapt in patients without MCL, or platelet count less than 25 x 10
Danish: 9/l som tilskrives Rydapt hos patienter uden mastcelleleukæmi, eller trombocyttal på mindre end 25 x 10
English: Severe renal impairment
Danish: Orofaryngeale smerter
English: Rydapt 25 mg soft capsules
Danish: Rydapt 25 mg kapsler, bløde
English: Very common (may affect more than 1 in 10 people) - infection at catheter site - red or purple, flat, pinhead spots under the skin (petechiae) - problems falling asleep (insomnia) - headache - shortness of breath, laboured breathing (dyspnoea) - dizziness, light-headedness (low blood pressure) - nose bleeds - throat pain (laryngeal pain) - mouth sores (stomatitis) - nausea, vomiting - upper abdominal pain - haemorrhoids (piles) - excessive sweating - skin rash with flaking or peeling (exfoliative dermatitis) - back pain - joint pain (arthralgia) - fever - thirst, high urine output, dark urine, dry flushed skin (signs of high levels of sugar in the blood,
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) - infektion på stedet, hvor kateteret er anlagt - røde eller blåviolette, flade, punktformede pletter under huden (petekkier) - problemer med at falde i søvn (insomni) - hovedpine - åndenød, vejrtrækningsbesvær (dyspnø) - svimmelhed, ørhed (lavt blodtryk) - næseblod - ondt i halsen (smerter i struben) - mundsår (stomatitis) - kvalme, opkastning - mavesmerter - hæmorider - udtalt svedtendens - hududslæt med skældannelse eller afskalning (exfoliativ dermatitis) - rygsmerter - ledsmerter (artralgi) - feber - tørst, høj urinproduktion, mørk urin, tør blussende hud (tegn på højt blodsukkerniveau, kendt som hyperglykæmi) - muskelsvaghed, døsighed, forvirring, kramper, nedsat bevidsthedsniveau (tegn på højt niveau af natrium i blodet, kendt som hypernatriæmi) - muskelsvaghed, muskelkramper, unormal hjerterytme (tegn på lavt niveau af kalium i blodet,
English: Rydapt dosing
Danish: Dosering af Rydapt
English: Discontinue Rydapt if low platelet count persists for >21 days and is suspected to be related to Rydapt.
Danish: Afbryd doseringen af Rydapt, hvis der i >21 dage ses vedvarende lavt trombocyttal, som formodes at være relateret til Rydapt.
English: How to take Rydapt
Danish: Sådan skal du tage Rydapt
English: Haemorrhoids
Danish: Sinustakykardi
English: Capsule content
Danish: Kapsel
English: What Rydapt is and what it is used for What you need to know before you take Rydapt How to take Rydapt
Danish: Det skal du vide, før du begynder at tage Rydapt Sådan skal du tage Rydapt Bivirkninger
English: Caution is required when concomitantly prescribing with midostaurin medicinal products that are strong inhibitors of CYP3A4, such as, but not limited to, antifungals (e.g. ketoconazole), certain antivirals (e.g. ritonavir), macrolide antibiotics (e.g. clarithromycin) and nefazodone because they can increase the plasma concentrations of midostaurin especially when (re-)starting with midostaurin treatment (see section 4.5).
Danish: Det skyldes, at disse lægemidler kan øge plasmakoncentrationerne af midostaurin, især ved (gen-)start af en behandling med midostaurin (se pkt.
English: Interrupt Rydapt for 3 days (6 doses), then resume at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily.
Danish: Genoptag herefter doseringen med 50 mg to gange daglig, og øg gradvist til 100 mg to gange daglig, hvis dette tolereres.
English: 9/l, then resume Rydapt at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Danish: Genoptag herefter doseringen af Rydapt med 50 mg to gange daglig, og øg til 100 mg to gange daglig, hvis dette tolereres.
English: • in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive (see section 4.2);
Danish: • til voksne patienter med nydiagnosticeret akut myeloid leukæmi (AML), som er FLT3mutation-positive (se pkt.
English: Fall
Danish: Ødem
English: Pleural effusion
Danish: Akut lungesvigt
English: Haematoma
Danish: Hæmorider
English: 36.8 (5.5, NE)
Danish: 36,8 (5,5, NE) 10,7 (7,4, 22,8) NR (3,6, NE)
English: 9/l, then resume at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily.
Danish: Genoptag herefter doseringen med 50 mg to gange daglig, og øg til 100 mg to gange daglig, hvis dette tolereres.
English: Median EFS in months, considering CRs within 60 days of treatment start (95% CI)
Danish: 60 dage efter behandlingsstart (95 % CI)
English: - For patients with AML, Rydapt is taken with chemotherapy medicines.
Danish: Hos patienter med komplet respons gives efterfølgende Rydapt monoterapi som vedligeholdelsesbehandling;
English: Acute respiratory distress syndrome
Danish: Mave-tarm-kanalen Kvalme
English: 90 (3 x 30) tablets (multipack)
Danish: 90 (3 X 30) tabletter (multipakning)
English: Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Pack size
Danish: 1 of 1
English: Overall summary of the scientific evaluation of Methylphenidate Hexal and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Methylphenidate Hexal og relaterede navne (se bilag I)
English: Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health.
Danish: Nederlandene og Tyskland fandt, at udstedelse af markedsføringstilladelsen udgør en potentiel alvorlig risiko for den offentlige sundhed,
English: The application for Methylphenidate Hexal is therefore based on bioequivalence studies between the applied and the reference product.
Danish: Ansøgningen for Methylphenidate Hexal er derfor baseret på bioækvivalensundersøgelser mellem det ansøgte produkt og referenceproduktet.
English: The major concern raised by Germany could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP.
Danish: Den væsentlige betænkelighed, der blev rejst af Tyskland og Nederlandene, kunne ikke afklares ved indbringelsen for CMD(h), og sagen blev derfor indbragt for CHMP.
English: Methylphenidate Hexal (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Danish: Methylphenidate Hexal (18 mg, 36 mg og 54 mg) er indiceret til behandling af hyperaktiv opmærksomhedsforstyrrelse (ADHD) hos børn i alderen 6-18 år og tages én gang dagligt om morgenen, enten sammen med et måltid eller mellem måltiderne.
English: Regarding the results obtained in the fed study (2009-18-PRT-2) it was shown that when compared to the fasting study several subjects did not have a biphasic profile but a continuous profile without an early maximum, whereby methylphenidate concentrations slowly increase after an erratic lag time.
Danish: For resultaterne af undersøgelsen i postprandial tilstand (2009-18-PRT-2) blev det vist, at sammenlignet med den fastende undersøgelse havde flere af personerne ikke en bifasisk profil, men en kontinuert profil uden et tidligt maksimum, hvor koncentrationerne af methylphenidat stiger langsomt efter en uberegnelig tidsforsinkelse.