FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisations for medicinal products containing METHYLPHENIDATE
Danish: Markedsføringstilladelser for lægemidler indeholdende METHYLPHENIDAT at
English: Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses.
Danish: Dyrestudier har kun påvist reproduktionstoksicitet ved toksiske doser h
English: Study on sexual maturation: a 2-year, long-term, open-label, prospective investigator initiated study in the US on 150 adolescents (12-17 years) with ADHD, to determine whether treatment with methylphenidate will prevent smoking in this population.
Danish: Undersøgelse af kønsmodning: en 2-årig, åben, prospektiv langtidsundersøgelse ig investigator i USA med 150 børn og unge (12-17 år) med ADHD, der har til formål behandling med methylphenidat kan forebygge rygning i denne population.
English: The MAHs commit to provide all available retrospective data on an annual review basis for the next five years in all Member States where methylphenidate is used, to allow an evaluation of changes in usage over time.
Danish: Indehaverne af markedsføringstilladelserne har også påtaget sig at fremskaffe alle tilgængelige retrospektive data med henblik på gennemgang én gang om året i de næste fem år i alle medlemsstater, hvor methylphenidat anvendes, for at gøre det muligt at vurdere ændringer i lægemiddelbrugen over tid.
English: The diagnosis should therefore be considered in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during methylphenidate therapy.
Danish: Diagnosen bør derfor overvejes hos enhver patient, som udvikler nye neurologiske symptomer, som er i overensstemmelse med cerebral iskæmi under behandling med methylphenidat.
English: 2.1.a Data from clinical trials
Danish: 2.1.a Data fra kliniske undersøgelser
English: Very common: headache
Danish: Meget almindelig: hovedpine
English: A clear safety signal for Reynaud's phenomenon was detected and the CHMP's opinion is that there is sufficient evidence from the reviewed data to suspect a causal relationship between methylphenidate use and these reactions.
Danish: Der blev påvist en tydelig sikkerhedsrisiko for Reynauds fænomen, og CHMP er af der foreligger tilstrækkelig dokumentation i de gennemgåede data til, at man kan ha årsagssammenhæng mellem brug af methylphenidat og disse reaktioner.
English: Pregnancy-embryonal/foetal development
Danish: Graviditet-embryonal/føtal udvikling
English: Aside from the issue of growth, there is lack of adequate clinical or pharmacoepidemiological data on the effects of long-term treatment with methylphenidate in the EU, in relation to cardiovascular, cerebrovascular, psychiatric, carcinogenicity or any other long-term risks.
Danish: Ud over vækstspørgsmålet er der ikke tilstrækkelige kliniske eller farmakoepidemiologiske data om virkningerne af langtidsbehandling med methylphenidat i EU, med hensyn til de langsigtede risici for kardiovaskulære, cerebrovaskulære, psykiatriske, carcinogene eller andre bivirkninger.
English: However, a harmonisation exercise between products is deemed one of the main scopes of this procedure to ensure the same level of health protection in all Member States where methylphenidate products are authorised.
Danish: om ovenstående nne procedure anses dog for at være en harmonisering af disse produkter for at sikre ensartet niveau af sundhedsbeskyttelse i alle medlemsstater, hvor methylphenidat er godkendt til markedsføring.
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: sstaten, hvor dette er relevant, ende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
English: Cases of abuse and dependence have been described, more often with immediate release formulations (frequency not known)
Danish: Tilfælde med misbrug og afhængighed er beskrevet hyppigere med formuleringer med hurtig frigivelse.
English: Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of methylphenidate and early treatment.
Danish: Tidlig diagnosticering, som i høj grad er baseret på mistanke, kan fordre hurtig seponering af methylphenidat og tidlig behandling.
English: A-1235 Wien
Danish: A-1235 Wien ner
English: Cytogenicity
Danish: Cytogenicitet
English: DK-3460 Birkerød Denmark
Danish: DK-3460 Birkerød Danmark
English: The short- and long-term clinical consequences of these cardiovascular effects in children and adolescents are not known, but the possibility of clinical complications cannot be excluded as a result of the effects observed in the clinical trial data.
Danish: De kort- og langsigtede klinis kardiovaskulære virkninger hos børn og unge er ikke kendt, men muligheden for kl komplikationer kan, grundet de virkninge udelukkes.
English: • about any medications you or your child is taking
Danish: • eventuel anden medicin, som du eller dit barn tager
English: Common: anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children*
Danish: Almindelig: anoreksi, nedsat appetit, moderat nedsat vægtøgning og vækst ved langvarig brug hos børn*
English: Due to the prolonged-release design of the tablet, {Invented name} should only be used in patients who are able to swallow the tablet whole.
Danish: Grundet tablettens design med modificeret udløsning, bør {Produktnavn} kun anvendes til patienter, som er i stand til at synke tabletten hel.
English: Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.
Danish: Misbrug af centralstimulerende midler kan være forbundet med pludselig død og andre alvorlige kardiovaskulære bivirkninger.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III
Danish: Som følge heraf har CHMP anbefalet at opdatere markedsføringstilladelserne for de lægemidler, der henvises til i bilag I, og for hvilke ændringerne til de relevante afsnit i produktresuméerne og indlægssedlerne er anført i bilag III.
English: Choice of methylphenidate formulation
Danish: Valg af methylphenidatformulering
English: i) adverse cognitive outcomes ii) adverse psychiatric outcomes (e.g. mood disorders, hostility and psychotic disorders)
Danish: i) uønskede kognitive resultater ii) uønskede psykiatriske resultater (f.eks. stemningsforstyrrelser, fjendtlighed og
English: If you or your child is not growing or gaining weight as expected, then you or your child's treatment with methylphenidate may be stopped for a short time
Danish: Hvis du eller dit barn ikke vokser eller tager på i vægt som barns behandling med methylphenidat måske stoppes et kort stykke tid.
English: ISERLOHN/Germany
Danish: ISERLOHN/Tyskland
English: Novartis Norge AS Brynsalleèn 4 0667 Oslo, Norway
Danish: ge AS Brynsalleèn 4 0667 Oslo, Norge
English: If the feasibility assessment shows that a scientifically valid, well-designed and suitably powered study is viable, then the MAHs commit to provide a detailed protocol.
Danish: Hvis vurdering gennemføre undersøgelsen viser, at en videnskabeligt gyldig, veldesignet undersøg tilstrækkelig statistisk styrke er gennemførlig, har indehaverne af sig at udarbejde en detaljeret protokol.
English: The literature also suggests that methylphenidate can exacerbate psychiatric disorders in patients with ADHD.
Danish: I litteraturen antydes det også, at methylphenidat kan forværre psykiatriske lidelser hos patienter med ADHA.
English: Methylphenidate is associated with the worsening of pre-existing anxiety, agitation or tension.
Danish: Methylphenidat er associeret med forværring af forudeksisterende angst, agitation eller anspændthed.
English: {The MA Holder should describe the dose conversion (between formulations) and the dose titration steps that are relevant to the formulation and strength of their own methylphenidate product, in each methylphenidate SPC in the EU}
Danish: {Indehaveren af markedsføringstilladelsen bør beskrive dosis konvertering (mellem samt trin i dosistitreringen, som er relevante for formuleringen og styrken af deres produkt, i hvert methylphenidat produktresume i EU}
English: In the Member States that are covered by the IMS database, the MAHs will also evaluate off-label use of methylphenidate.
Danish: I de medlemsstater, der er omfattet af IMS-databasen, vil indehaverne af markedsf også evaluere brugen af methylphenidat uden for den godkendte indikation.
English: Remember that some foods and medicines contain alcohol.
Danish: Husk, at nogle madvarer og lægem
English: Fatigue Methylphenidate should not be used for the prevention or treatment of normal fatigue states.
Danish: Træthed Methylphenidat skal ikke anvende til forebyggelse eller behandling af normale træthedstilstande.
English: Although the study focuses on smoking prevention, Tanner staging examinations will occur every 6 months during the 2-year follow-up and will monitor each subject's pubertal development to demonstrate whether methylphenidate has any effect on adolescent growth and development compared to population norms.
Danish: Selvom fokus på forebyggelse af rygning, vil der blive foretaget undersøgelser af Tanner-st i løbet af 2-års-opfølgningen, og hver forsøgspersons pubertetsudvikling vil bliv demonstrere, hvorvidt methylphenidat har nogen indvirkning på væk sammenlignet med populationsnormerne.
English: SK - Slovakia Johnson & Johnson, s. r. o. Plynárenská 7/B
Danish: SK - Slovakiet Johnson & Johnson, s. r. o. Plynárenská 7/B
English: The MAHs will consider including predominantly EU-based data, and the feasibility assessment will also comment on what non-EU sources of data could be used as an alternative.
Danish: Indehaverne af markedsføringstilladelserne vil overveje at inkludere overvejend og vurderingen af muligheden for at gennemføre undersøgelsen vil også hvilke ikke-EU-datakilder der alternativt kunne anvendes.
English: Methylphenidate should be used with caution in patients with epilepsy.
Danish: Anfald Methylphenidat skal anvendes med forsigtighed hos patienter med epilepsi.
English: Methylphenidate may have some activity as a nongenotoxic carcinogen in mouse liver; however, the limited human analyses do not suggest that this activity is reproduced in humans exposed to therapeutic doses.
Danish: Methylphenidat har muligv ikke-genotokcisk carcinogen i lever hos mus, men de begrænsede analyser med m dog ikke, at denne aktivitet reproduceres hos mennesker, som eksponeres for terap
English: 2.5 Leukaemia
Danish: 2.5 Leukæmi
English: The product information for most of the methylphenidate-containing products in the EU contain warnings for use in patients with underlying cardiac disorders and lists many of the disorders reported with cyanosis as possible ADRs in section 4.8.
Danish: Produktinformationen for de fleste methylphenidatholdige produkter i EU omfatter advarsler om brug til patienter med underliggende hjertesygdomme og opremser mange af de lidelser, der er indberettet om cyanose som mulige bivirkninger under pkt.
English: Ongoing monitoring: Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
Danish: Patientens vækst, psykiatiske status og kardiovaskulære status skal monitoreres kontinuerligt (se også pkt.
English: Methylphenidate is not indicated for use in patients who may display some symptoms of ADHD but have not been formally diagnosed.
Danish: Methylphenidat er ikke indiceret til brug hos patienter, som muligvis har symptom som ikke er blevet formelt diagnosticeret.
English: Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate.
Danish: Før methylphenidat ordineres er det nødvendigt, at udføre en baseline-evaluering af patientens kardiovaskulære status, herunder blodtryk og hjertefrekvens.
English: Ratiopharm Nederland BV; Ronde Tocht 11;1507 CC ZAANDAM/NL
Danish: Ratiopharm Nederland BV; Tocht 11;1507 CC Z
English: You should check with your <doctor> <or> <pharmacist> if you are not sure.> <The usual dose is...>
Danish: Er <De><du> i tvivl, så spørg lægen eller på apoteket.> <Den sædvanlige dosis er…>
English: Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics.
Danish: Produkter, der inducerer eller hæmmer cytochrom P450, forventes ikke at have nogen relevant indflydelse på methylphenidats farmakokinetik.
English: Methylphenidate did not affect reproductive performance or fertility at low multiples of the clinical dose.
Danish: Methylphenidat påvirker ikke reproduktionsevnen eller fertilitet i lave kliniske doser.
English: If you <take> <use> more methylphenidate than you should If you or your child takes too many tablets, contact the doctor or nearest hospital casualty department immediately and tell them how many tablets have been taken.
Danish: Hvis <De><du> har <taget> <brugt> for <meget> methylphenidat Hvis du eller dit barn tager for mange tabletter, skal du straks søge læge eller den og fortælle dem, hvor mange tabletter du eller dit barn har
English: • paralysis or impairment of movement and vision, difficulties in speech (could be symptoms of cerebral vasculitis).
Danish: • lammelse eller nedsat bevægelse og syn, talevanskeligheder (kan være s vasculitis).
English: Close ongoing monitoring is essential in these patients (see above ‘Psychiatric Disorders' and section 4.2) .
Danish: Tæt vedvarende monitorering hos disse patien ovenfor ”Psykiatriske sygdomme” og pkt.
English: Methylphenidate should be used with caution in patients with known drug or alcohol dependency because of a potential for abuse, misuse or diversion.
Danish: Methylphenidat bør anvendes med forsigtighed hos patienter med kendt stof- eller alkoholafhængighed, da der er potentiale for misbrug, forkert brug eller brug til fo
English: It is not known how methylphenidate may effect plasma concentrations of concomitantly administered drugs.
Danish: Det vides ikke, hvordan methylphenidat påvirker plasmakoncentrationerne af lægem administreres samtidig.
English: However, there are reports indicating that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g. phenobarbitol, phenytoin, primodone) and some antidepressants (tricyclics and selective serotonin reuptake inhibitors).
Danish: Indberetninger viser dog, at methylphenidat kan hæmme metabolismen af coumarine antikoagulanter, antikonvulsiva (f.eks. phenobarbital, phenytoin, primidon), og nogle antidepressiva (tricykliske og selektive serotoninoptagelseshæmmere).
English: BE - Belgium NOVARTIS PHARMA N.V. Medialaan, 40
Danish: BE - Belgien NOVARTIS PHARM Medialaan, 40
English: D-27457 Cuxhaven
Danish: D-27457 Cuxh
English: D-22767 Hamburg
Danish: D-22767 Hamburg n
English: Before performing gastric lavage, control agitation and seizures if present and protect the airway.
Danish: Før der foretages ventrikelskylning, skal agitation og eventuelle anfald kontrolleres, og luftvejen beskyttes.
English: • Physicians guide to prescribing
Danish: • Ordinationsvejledning til læger
English: DE - Germany Medice Postfach 2063
Danish: DE - Tyskland Medice Postfach 2063
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of drugs in nondeformable prolonged-release formulations.
Danish: Der er indberettet sjældne rapporter om obstruktive patienter med kendte strikturer i forbindelse med indtagelse af stoffer i ikke-deform formuleringer med modificeret ud
English: Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.
Danish: Forsigtighed er nødvendig ved behandling af patienter, hvis un medicinske tilstande kan kompromitteres ved stigning i blodtryk eller hj
English: Methylphenidate treatment is usually discontinued during or after puberty.
Danish: Behandling med methylphenidat seponeres sædvanligvis under eller efter puberteten.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigt
English: Methylphenidate treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child's symptoms in relation to the child's age.
Danish: Behandling med methylphenidat er ikke indiceret til alle børn med ADHD, og beslu anvende stoffet skal være baseret på en meget grundig vurdering af sværhedsgra barnets symptomer i forhold til barnets alder.
English: • height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart;
Danish: • Højde, vægt og appetit bør kontrolleres minimum hver 6. måned og anføres fortløbende på en vækstkurve;
English: Lactation Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate
Danish: Der er fundet methylphenidat i brystmælken hos kvinder, som blev behandlet med methylphenidat.
English: Study designed to: 1) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in children and youth, aged 2-24 years; 2) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in adults, aged 25-64 years; and, 3) perform additional analyses that are relevant to decision makers such as clinicians, state Medicaid programs, and parents/patients.
Danish: Kardiovaskulære og cerebrovasulære virkninger dersøgelse, der har til formål at: 1) vurdere forholdet mellem brug af lægemidler mod ADHD og risikoen sygdom hos børn og unge i alderen 2 2) vurdere forholdet mellem brug af lægemidler mod ADHD og risikoen for sygdom hos voksne i alderen 25-64 år; og 3) foretage yderligere analyser med relevans for beslutningstagere s sygesikringsprogram
English: SE-192 07 Sollentuna Sweden
Danish: SE-192 07 Sollen Sverige
English: Some of these were conditions in which the use of methylphenidate is warned against or contra-indicated.
Danish: Nogle af disse var tilstande, hvortil der advares mod at bruge methylphenidat, eller hvor d kontraindiceret.
English: Cases of neonatal cardiorespiratory toxicity, specifically fetal tachycardia and respiratory distress have been reported in spontaneous case reports.
Danish: Tilfælde af neonatal kardiorespiratorisk toksicitet, især takykardi og respiratorisk rapporteret ved spontan rapportering.
English: The CHMP therefore agreed that in order to ensure any effect on growth is minimised, improved and harmonised warnings, guidelines on monitoring (frequency of monitoring, method of measurement) and actions to take, should be implemented in the SPC and the PL.
Danish: CHMP blev derfor enige om, at for at sikre at eventuelle virkninger på vækst blev minimeret, skulle rmoniserede advarsler, retningslinjer om overvågning (overvågningsfrekvens, g indlægssedlen.
English: FR - France UCB PHARMA S.A. 21 rue de Neuilly
Danish: FR - Frankrig UCB PHARMA S.A. 21 rue de Neuilly
English: Some pre-clinical evidence was submitted suggesting that there is a differential effect of acute vs. chronic treatment with methylphenidate on expression of genes involved in neuronal plasticity, a differential effect of methylphenidate exposure in juveniles vs adults on expression of central neurotransmitter receptors and an effect of treatment in adolescence on survival of new brain cells.
Danish: Der blev indsendt nogle prækliniske data, som antydede, at der foreligger en differentieret virkning af akut henholdsvis kronisk behandling med methylphenidat på ekspressionen af de gener, der er involveret i neuronal plasticitet, en differentieret virkning af methylphenidateksponering hos henholdsvis unge og voksne på de centrale neurotransmitterreceptorer samt en virkning af behandling hos unge på overlevelsen af nye hjerneceller.
English: Clinical evaluation for anxiety, agitation or tension should precede use of methylphenidate and patients should be regularly monitored for the emergence or worsening of these symptoms during treatment, at every adjustment of dose and then at least every 6 month or every visit.
Danish: Klinisk evaluering for angst, agitation eller anspændthed bør gå forud for anvendelse af methylphenidat og patienterne bør regelmæssigt monitoreres for udvikling eller forværring af disse symptomer under behandling, ved hver dosisjustering og efterfølgende minimum hver 6. måned eller ved hver konsultation.
English: Novartis Healthcare Lyngbyvej 172
Danish: Novartis Healthcare vej 172
English: Moderately reduced weight gain and growth retardation have been reported with the long-term use of methylphenidate in children.
Danish: Der er rapporteret om moderat reduceret vægtøgning og væksthæmning ved lang methylphenidat hos børn.
English: It may have a moderate influence on the ability to drive and use machines.
Danish: Det kan have en moderat påvirkning på evnen til at tilrådes til at undg
English: Methylphenidate should not be used in children under the age of 6 years.
Danish: Methylphenidat bør ikke anvendes til børn under 6 år.
English: The MAHs committed to provide a detailed feasibility assessment for a scientifically valid, welldesigned and suitably powered long-term safety study to examine specific endpoints for the following outcomes:
Danish: Indehaverne af markedsføringstilladelserne har påtaget sig at fremskaffe en detaljer muligheden for at foretage en videnskabeligt gyldig, veldesignet undersøgelse af langsigtet sikkerhed, som har tilstrækkelig statistisk styrke, med henblik på at undersøge specifikke end behandlingsresultater:
English: FR - France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
Danish: FR - Frankrig JANSSEN CILAG S 1 rue Camille Desm TSA 91003
English: Forms of bipolar disorder
Danish: Typer af bipolar sygdom
English: Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products.
Danish: Komorbiditet mellem psykiatriske sygdomme og ADHD er almindelig, og dette s betragtning ved ordination af stimulerende midler.
English: The signs of ADHD may persist into adolescence and adulthood, and may be associated with continuing emotional and social problems, unemployment, criminality and substance misuse.
Danish: Tegnene på ADHD kan fortsætte ind voksenlivet og kan være forbundet med vedvarende følelsesmæssige og soc arbejdsløshed, kriminalitet og st
English: Long Term Use effects
Danish: Langtidsvirkninger
English: Very rare: cerebral arteritis and/or occlusion, peripheral coldness, Raynaud's phenomenon
Danish: Meget sjælden: cerebral arteritis og/eller okklusion, kuldefornemmelser, Raynauds fænomen
English: In addition the harmonisation of the submission of the PSURs and the Risk Management Plans (RMP) by the MAHs will insure that the safety information is assessed simultaneously by the Members States via the PhVWP and the continuity of the harmonisation will be ensured.
Danish: Derudover vil harmoniseringen af indsendelsen af PSUR'er og risikostyringsplanerne (RMP) fra ingstilladelserne sikre, at sikkerhedsoplysningerne vurderes samtidigt i oniseringen sikres.
English: Recent findings from a case-control study have indicated a potentially increased risk of lymphocytic leukaemia with methylphenidate, which the MAHs were required to further evaluate.
Danish: Nylige resultater fra en case-kontrolleret undersøgelse viste en potentielt øget r leukæmi ved behandling med methylphenidat, hvilket indehaverne af markedsførin bedt om at evaluere yderligere.
English: Pregnancy and breast-feeding Tell your doctor or pharmacist before using methylphenidate if you or your child is: - sexually active.
Danish: Fortæl det til lægen eller på apoteket, før du tager methylphenidat, hvis du eller dit barn er: - seksuelt aktiv.