natgillin/translations-raw huggingface dataset:
Diagnosen bør derfor overvejes hos enhver patient, som udvikler nye neurologiske symptomer, som er i overensstemmelse med cerebral iskæmi under behandling med methylphenidat.
The diagnosis should therefore be considered in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during methylphenidate therapy.
2.1.a Data fra kliniske undersøgelser
2.1.a Data from clinical trials
Meget almindelig: hovedpine
Very common: headache
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.
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.
Graviditet-embryonal/føtal udvikling
Pregnancy-embryonal/foetal development
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.
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.
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.
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.
sstaten, hvor dette er relevant, ende betingelser opfyldes af indehaverne af markedsføringstilladelsen:
National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Tilfælde med misbrug og afhængighed er beskrevet hyppigere med formuleringer med hurtig frigivelse.
Cases of abuse and dependence have been described, more often with immediate release formulations (frequency not known)
Tidlig diagnosticering, som i høj grad er baseret på mistanke, kan fordre hurtig seponering af methylphenidat og tidlig behandling.
Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of methylphenidate and early treatment.
A-1235 Wien ner
A-1235 Wien
Cytogenicitet
Cytogenicity
DK-3460 Birkerød Danmark
DK-3460 Birkerød Denmark
De kort- og langsigtede klinis kardiovaskulære virkninger hos børn og unge er ikke kendt, men muligheden for kl komplikationer kan, grundet de virkninge udelukkes.
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.
• eventuel anden medicin, som du eller dit barn tager
• about any medications you or your child is taking
Almindelig: anoreksi, nedsat appetit, moderat nedsat vægtøgning og vækst ved langvarig brug hos børn*
Common: anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children*
Grundet tablettens design med modificeret udløsning, bør {Produktnavn} kun anvendes til patienter, som er i stand til at synke tabletten hel.
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.
Misbrug af centralstimulerende midler kan være forbundet med pludselig død og andre alvorlige kardiovaskulære bivirkninger.
Misuse of stimulants of the central nervous system may be associated with sudden death and other serious cardiovascular adverse events.
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.
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
Valg af methylphenidatformulering
Choice of methylphenidate formulation
i) uønskede kognitive resultater ii) uønskede psykiatriske resultater (f.eks. stemningsforstyrrelser, fjendtlighed og
i) adverse cognitive outcomes ii) adverse psychiatric outcomes (e.g. mood disorders, hostility and psychotic disorders)
Hvis du eller dit barn ikke vokser eller tager på i vægt som barns behandling med methylphenidat måske stoppes et kort stykke tid.
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
ISERLOHN/Tyskland
ISERLOHN/Germany
ge AS Brynsalleèn 4 0667 Oslo, Norge
Novartis Norge AS Brynsalleèn 4 0667 Oslo, Norway
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.
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.
I litteraturen antydes det også, at methylphenidat kan forværre psykiatriske lidelser hos patienter med ADHA.
The literature also suggests that methylphenidate can exacerbate psychiatric disorders in patients with ADHD.
Methylphenidat er associeret med forværring af forudeksisterende angst, agitation eller anspændthed.
Methylphenidate is associated with the worsening of pre-existing anxiety, agitation or tension.
{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}
{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}
I de medlemsstater, der er omfattet af IMS-databasen, vil indehaverne af markedsf også evaluere brugen af methylphenidat uden for den godkendte indikation.
In the Member States that are covered by the IMS database, the MAHs will also evaluate off-label use of methylphenidate.
Husk, at nogle madvarer og lægem
Remember that some foods and medicines contain alcohol.
Træthed Methylphenidat skal ikke anvende til forebyggelse eller behandling af normale træthedstilstande.
Fatigue Methylphenidate should not be used for the prevention or treatment of normal fatigue states.
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.
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.
SK - Slovakiet Johnson & Johnson, s. r. o. Plynárenská 7/B
SK - Slovakia Johnson & Johnson, s. r. o. Plynárenská 7/B
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.
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.
Anfald Methylphenidat skal anvendes med forsigtighed hos patienter med epilepsi.
Methylphenidate should be used with caution in patients with epilepsy.
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
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.
2.5 Leukæmi
2.5 Leukaemia
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.
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.
Patientens vækst, psykiatiske status og kardiovaskulære status skal monitoreres kontinuerligt (se også pkt.
Ongoing monitoring: Growth, psychiatric and cardiovascular status should be continuously monitored (see also Section 4.4).
Methylphenidat er ikke indiceret til brug hos patienter, som muligvis har symptom som ikke er blevet formelt diagnosticeret.
Methylphenidate is not indicated for use in patients who may display some symptoms of ADHD but have not been formally diagnosed.
Før methylphenidat ordineres er det nødvendigt, at udføre en baseline-evaluering af patientens kardiovaskulære status, herunder blodtryk og hjertefrekvens.
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate.
Ratiopharm Nederland BV; Tocht 11;1507 CC Z
Ratiopharm Nederland BV; Ronde Tocht 11;1507 CC ZAANDAM/NL
Er <De><du> i tvivl, så spørg lægen eller på apoteket.> <Den sædvanlige dosis er…>
You should check with your <doctor> <or> <pharmacist> if you are not sure.> <The usual dose is...>
Produkter, der inducerer eller hæmmer cytochrom P450, forventes ikke at have nogen relevant indflydelse på methylphenidats farmakokinetik.
Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics.
Methylphenidat påvirker ikke reproduktionsevnen eller fertilitet i lave kliniske doser.
Methylphenidate did not affect reproductive performance or fertility at low multiples of the clinical dose.
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
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.
• lammelse eller nedsat bevægelse og syn, talevanskeligheder (kan være s vasculitis).
• paralysis or impairment of movement and vision, difficulties in speech (could be symptoms of cerebral vasculitis).
Tæt vedvarende monitorering hos disse patien ovenfor ”Psykiatriske sygdomme” og pkt.
Close ongoing monitoring is essential in these patients (see above ‘Psychiatric Disorders' and section 4.2) .
Methylphenidat bør anvendes med forsigtighed hos patienter med kendt stof- eller alkoholafhængighed, da der er potentiale for misbrug, forkert brug eller brug til fo
Methylphenidate should be used with caution in patients with known drug or alcohol dependency because of a potential for abuse, misuse or diversion.
Det vides ikke, hvordan methylphenidat påvirker plasmakoncentrationerne af lægem administreres samtidig.
It is not known how methylphenidate may effect plasma concentrations of concomitantly administered drugs.
Indberetninger viser dog, at methylphenidat kan hæmme metabolismen af coumarine antikoagulanter, antikonvulsiva (f.eks. phenobarbital, phenytoin, primidon), og nogle antidepressiva (tricykliske og selektive serotoninoptagelseshæmmere).
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).
BE - Belgien NOVARTIS PHARM Medialaan, 40
BE - Belgium NOVARTIS PHARMA N.V. Medialaan, 40
D-27457 Cuxh
D-27457 Cuxhaven
D-22767 Hamburg n
D-22767 Hamburg
Før der foretages ventrikelskylning, skal agitation og eventuelle anfald kontrolleres, og luftvejen beskyttes.
Before performing gastric lavage, control agitation and seizures if present and protect the airway.
• Ordinationsvejledning til læger
• Physicians guide to prescribing
DE - Tyskland Medice Postfach 2063
DE - Germany Medice Postfach 2063
Der er indberettet sjældne rapporter om obstruktive patienter med kendte strikturer i forbindelse med indtagelse af stoffer i ikke-deform formuleringer med modificeret ud
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.
Forsigtighed er nødvendig ved behandling af patienter, hvis un medicinske tilstande kan kompromitteres ved stigning i blodtryk eller hj
Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.
Behandling med methylphenidat seponeres sædvanligvis under eller efter puberteten.
Methylphenidate treatment is usually discontinued during or after puberty.
4.4 Særlige advarsler og forsigt
4.4 Special warnings and precautions for use
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.
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.
• Højde, vægt og appetit bør kontrolleres minimum hver 6. måned og anføres fortløbende på en vækstkurve;
• height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart;
Der er fundet methylphenidat i brystmælken hos kvinder, som blev behandlet med methylphenidat.
Lactation Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate
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
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.
SE-192 07 Sollen Sverige
SE-192 07 Sollentuna Sweden
Nogle af disse var tilstande, hvortil der advares mod at bruge methylphenidat, eller hvor d kontraindiceret.
Some of these were conditions in which the use of methylphenidate is warned against or contra-indicated.
Tilfælde af neonatal kardiorespiratorisk toksicitet, især takykardi og respiratorisk rapporteret ved spontan rapportering.
Cases of neonatal cardiorespiratory toxicity, specifically fetal tachycardia and respiratory distress have been reported in spontaneous case reports.
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.
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.
FR - Frankrig UCB PHARMA S.A. 21 rue de Neuilly
FR - France UCB PHARMA S.A. 21 rue de Neuilly
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.
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.
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.
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.
Novartis Healthcare vej 172
Novartis Healthcare Lyngbyvej 172
Der er rapporteret om moderat reduceret vægtøgning og væksthæmning ved lang methylphenidat hos børn.
Moderately reduced weight gain and growth retardation have been reported with the long-term use of methylphenidate in children.
Det kan have en moderat påvirkning på evnen til at tilrådes til at undg
It may have a moderate influence on the ability to drive and use machines.
Methylphenidat bør ikke anvendes til børn under 6 år.
Methylphenidate should not be used in children under the age of 6 years.
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:
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:
FR - Frankrig JANSSEN CILAG S 1 rue Camille Desm TSA 91003
FR - France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003
Typer af bipolar sygdom
Forms of bipolar disorder
Komorbiditet mellem psykiatriske sygdomme og ADHD er almindelig, og dette s betragtning ved ordination af stimulerende midler.
Co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products.
Tegnene på ADHD kan fortsætte ind voksenlivet og kan være forbundet med vedvarende følelsesmæssige og soc arbejdsløshed, kriminalitet og st
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.
Langtidsvirkninger
Long Term Use effects
Meget sjælden: cerebral arteritis og/eller okklusion, kuldefornemmelser, Raynauds fænomen
Very rare: cerebral arteritis and/or occlusion, peripheral coldness, Raynaud's phenomenon
Derudover vil harmoniseringen af indsendelsen af PSUR'er og risikostyringsplanerne (RMP) fra ingstilladelserne sikre, at sikkerhedsoplysningerne vurderes samtidigt i oniseringen sikres.
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.
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.
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.
Fortæl det til lægen eller på apoteket, før du tager methylphenidat, hvis du eller dit barn er: - seksuelt aktiv.
Pregnancy and breast-feeding Tell your doctor or pharmacist before using methylphenidate if you or your child is: - sexually active.
Det primære formål var at undersøge produktets kardiovaskulære risiko ved behand der blev også undersøgt andre risici: cerebrovaskulær, indvirkning på vækst og lang den psykiatriske risiko og en potentiel risiko for leukæmi.
The main objective was the cardiovascular risk of the product to children but additionally other risks were also evaluated; cerebrovascular, effect on growth and long term treatment, the psychiatric risk and a potential risk of leukaemia.
Methylphenidat metaboliseres ikke i klinisk relevant grad af cytochrom P450.
Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent.
Meget sjælden: Anæmi, leukopeni, trombocytopeni, trombocytopenisk purpura Ikke kendt: Pancytopeni
Very rare: Anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura Unknown: Pancytopenia
Pludselig hjertedød*
Very rare: sudden cardiac death*
Indehaverne af markedsføringstilladelserne skal nøje overvåge indberetninger om cyanose i fremtidige PSUR-rapporter og medtage dem under reaktioner, der skal følges op på.
The MAHs should closely monitor reports of cyanosis in future PSURs, including them as terms for targeted follow-up.
Behandling med methylphenidat er ikke kontraindiceret hos patienter med hemiplegisk cerebral lammelse.
Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral palsy
• Diagnosticeret alvorlig episodisk (Type I) bipolar (affektiv) sindslidelse (som velkontrolleret) eller anamnese med alvorlig episodisk (Type I) bipolar (affek (som ikke er velkontrolleret)
• Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not wellcontrolled)
Der bør udvises forsigtigh ustabile patienter, såsom patienter med stof- eller alkoholafhæ kan øge doseringen på eget initiativ.
Caution is called for in emotionally unstable patients, such as those with a history of drug or alcohol dependence, because such patients may increase the dosage on their own initiative.
Indehaverne skal harmonisere den relevante ordlyd i indlægssedlen, så den afspejler de foreslåede
The MAHs should harmonise the relevant wording of the Package Leaflet by reflecting the changes proposed in the SPC.
Indehaverne af markedsføringstilladelserne har også indvilliget i at undersøge langtidsvirkningen på udviklingen hos børn.
Furthermore, the MAHs committed to investigate the long term effect on children's development.
Indehaverne af markedsføringstilladelserne skal i risikostyringsplanen løbende evaluere nyligt identificerede eller potentielle risici, eller nye/vigtige oplysninger om eksisterende identificerede eller potentielle risici.
The MAHs should evaluate newly identified or potential risks, or new new/important information on existing identified or potential risks, in the RMP on an ongoing basis
Når en igangværende cytogenicitetsundersøgel muligvis besvares.
A currently ongoing cytogenicity study may give responses when finalised.