natgillin/translations-raw huggingface dataset:
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.
Meget sjælden: kramper, choreo-athetoide bevægelser, reversibel iskæmisk neurol Neuroleptisk malignt syndrom (NMS; rapporter var dårli ogisk deficit gt dokumenterede, og i de fleste tilfælde fik ebral arteritis, cerebral okklusion), grand mal-konvulsioner*, migræne patienter også anden medicin, hvorfor methylphenidats rolle er uklar). 
Very rare: convulsions, choreo-athetoid movements, reversible ischaemic neurological deficit Neuroleptic malignant syndrome (NMS; Reports were poorly documents and in most of cases, patients were also receiving other drugs, so the role of methylphenidate is unclear).
• eventuelle andre medicinske lidelser (for eksempel hjertelidelser), som familie har 
• about any other medical conditions (such as heart conditions) you, your child or you family may have.
ES - Spanien JANSSEN CILAG, SA Paseo de las doce estrellas , 5-7 
ES - Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
Derfor beslutter lægen, om du eller din datter bør amme under indtagelsen af methylphenidat. 
Therefore, your doctor will decide whether you or your daughter should breast-feed while using methylphenidate.
Selvom de fleste indberetninger om var antallet af indberetninger fra voksne højere end forventet (i de tilfælde, h med hensyn til centrale bivirkninger. 
Although most reports occurred in children and adolescents, there was a higher than expected number of reports in adults (where age was reported) for all of the key adverse event terms.
Tel:+34-93-772 25 09 Fax: +34-93-772 25 01 
Tel:+34-93-772 25 09
I livstidsstudier af karcinogenicitet i rotter og mus, sås øget forekomst af maligne levertumorer hos hanmus. 
In life-time rat and mouse carcinogenicity studies, increased numbers of malignant liver tumours were noted in male mice only.
ør monitoreres under behandling med methylphenidat: højde, vægt og appetit skal trolleres minimum hver 6. måned og anføres fortløbende på en vækstkurve. 
Growth should be monitored during methylphenidate treatment: height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart.
Din l andre medicinske test, før du eller dit barn tager denne medicin. 
Your doctor may decide you or your child need other medical tests before you or your child take this medicine.
øringstilladelserne Indehaverne af af undersøgelsen ndelse (hvor det er muligt) og brug uden for den godkendte indikation i de ale (på EU-plan) databaser såsom IMS. 
The MAHs will also consider alternative methods for completing the review of usage (where possible) and off-label use in the Member States that are not currently covered by multinational (EU-wide) databases such as IMS.
DK - Danmark Janssen-Cilag A/S Hammerbakken 19 
DK - Denmark Janssen-Cilag A/S Hammerbakken 19
Hvis bivirkninger forekommer, kan det være farligt at udføre risikable aktiviteter som at føre er, før du er sikker på, at du eller dit kke bliver påvirket. 
If such sideeffects occur it may be dangerous to perform any hazardous activities, such as driving, operating machinery, riding a bike or climbing trees until you are certain that you or your child will not be affected.
Tabellen nedenfor viser alle bivirkninger med {Produktnavn}, som blev observeret under kliniske forsøg og efter markedsføring, samt bivirkninger, som er blevet rapporteret med andre methylphenidathydrochlorid-formuleringer. 
The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with {invented name} and those, which have been reported with other methylphenidate hydrochloride formulations.
Indehaverne af arkedsføringstilladelserne har indvilliget i at distribuere uddannelsesmateriale, der skal vejlede de ter anmodning fra alle EU-medlemsstater 
The MAHs have committed to distribute education material for guidance of the prescribers.
Sikkerhed og virkning hos denne aldersgruppe er ikke fastlagt. 
Safety and efficacy in this age group has not been established.
For at din læge kan beslutte, om methylphenidat er lægen drøfte følgende med dig: 
In order for your doctor to decide if methylphenidate is the correct medicine for you or your child, your doctor will discuss the following with you:
Der er ingen specifik antidot ved overdosering med methylphenidat. 
Treatment There is no specific antidote to methylphenidate overdosage.
Da methylphenidat i overvejende grad virker ved at øge ekstracellulære dopaminniveauer, kan methylphenidat forbindes med farmakodynamisk administreres samtidigt med direkte eller indirekte dopaminagonister (herunder DO antidepressiva), eller med dop 
Because a predominant action of methylphenidate is to increase extracelluar dopamine levels, methylphenidate may be associated with pharmacodynamic interactions when co-administered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) or with dopamine antagonists including antipsychotics.
Der er begrænset information, som tyder på, a methylphenidat udskilles i modermælk. 
There is limited information that suggests that methylphenidate is passed into human breast milk.
ng konkluderede CHMP, at benefit/risk-forholdet for produkter indeholdende methylphenidat til behandling af ADHD hos børn fra 6 år kan anses som gunstigt, og udvalget anbefalede en opdatering af markedsføringstilladelsen i overensstemmelse med ændringerne i produktresuméet og indlægssedlen (som formuleret i bilag III) for de lægemiddelprodukter, der henvises til i bilag I. 
Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for methylphenidate containing products in the treatment of ADHD in children aged six and above, is considered favourable and recommended the maintenance of the Marketing Authorisation in accordance to the amendments of the Summary of Product Characteristics, and Package Leaflet (set out in Annex III) for the medicinal products referred to in Annex I.
Før du starter behandlingen, ved hver ændring af dosis og derefter mindst hver 6. m hvert besøg vil lægen foretage forskellige test for at sikkert og 
Before you start treatment, at every change of dose and then at least every 6 months or every visit your doctor will conduct various tests to make sure that methylphenidate is still acceptabley safe and beneficial.
- CHMP konkluderede, at produktinformationen for alle produkter indeholde skal indeholde de samme sikkerhedsoplysninger, og udvalget anbefalede de de relevante afsnit i p 
- The CHMP concluded that the Product Information of all methylphenidate-containing products should include the same safety information and therefore recommended the harmonisation of relevant sections of the Summaries of Product Characteristics and Package Leaflets.
Forsigtighed anbefales derfor ved samtidig administration a idler, som f methylphenidat og andre lægemidler, især lægemidler med et smalt terapeutisk vindue. 
Therefore, caution is recommended at combining methylphenidate with other drugs, especially those with a narrow therapeutic window.
<Tag/brug altid methylphenidat nøjagtigt efter lægens anvisning. 
<Always <take> <use> methylphenidate exactly as your doctor has told you.
Der findes muligvis andre styrker af dette lægemiddel og and methylphenidat. 
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
I litteraturen er der modstridende oplysni af methylphenidat på vækst og kønsmodning. 
The literature is conflicting with regards to the effects of methylphenidate on growth and sexual maturation.
2.8 Graviditet og amning 
2.8 Pregancy and lactation
idlet seponeres enten midlertidigt eller permanent. 
Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Det er nødvendigt omhyggeligt at titrere dosen ved starten af behandling med methylphenidat. 
Careful dose titration is necessary at the start of treatment with methylphenidate.
HU - Ungarn Novartis Hungária Kft.Pharma 1114 Budapest 
HU - Hungary Novartis Hungária Kft.Pharma 1114 Budapest
Tabletten d ratiopharm GmbH D-89070 Ulm 
DE - Germany ratiopharm GmbH D-89070 Ulm
4.3 for cerebrovaskulære tilstande hvor methylphenidat er kontraindiceret. 
See section 4.3 for cerebrovascular conditions in which methylphenidate treatment in contraindicated.
P yderligere risikofaktorer (såsom kardiovaskulær sygdom i anamnesen, samtidig lægemidler der øger blodtrykket) bør efter påbegyndt behandling med methylp neurologiske tegn og symptomer ved hver konsultation. 
Patients with additional risk factors (such as a history of cardiovascular disease, concomitant medications that elevate blood pressure) should be assessed at every visit for neurological signs and symptoms after initiating treatment with methylphenidate.
2100 København Ø Danmark 
2100 Københarn Ø Denmark
Antihypertensive lægemidler tte virkningen af lægemidler, som anvendes til behandling af hypertension. 
Anti-hypertensive drugs Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Behandling med methylphenidat bør ikke og behøver ikke være ubegrænset. 
Methylphenidate treatment should not and need not, be indefinite.
Novartis Ph Roonstrasse 90429 N Tyskland 
Novartis Pharma Roonstrasse 25 90429 Nűrnberg Germany
UCB Pharma Oy Finland Malm 5 00700 Helsinki FINLAND 
FI - Finland UCB Pharma Oy Finland Malminkaari 5 00700 Helsinki FINLAND
Misbrug og kardiovaskulære bivirkninger 
Misuse and Cardiovascular Events
CS - Den Tjekkiske k ske 
CS - Czech Republic
Janssen-Cila Box 7073 
SE - Sweden Janssen-Cilag AB Box 7073
Nervesystemet adfærd 
Nervous system disorders
Alle inde markedsføringstilladelserne skal derfor føje Reynauds fænomen til deres pr alle produkter, der indeholder methylphenidat. 
All MAHs are therefore required to add Raynaud's phenomenon to their Product Information (PI) for all methylphenidate-containing products.
rtæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for ny ette gælder også medicin, som ikke er købt på recept. 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Patienter, som får tanker om selvmord eller udviser selvmordsadfærd under beha skal straks vurderes af lægen. 
Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician.
• Bedømmelse af psykiatriske symptomer, hver gang dosis ændres og derefter mindst hver sjette måned eller ved hvert besøg. 
• Assessing psychiatric symptoms, each time your dose in changed and then at least every six months or at every visit.
paroxetin - medicin mod epilepsi (krampestillende medicin) (f.eks. phenobarbital, phenytoin, primidon etc. - medicin, som fortynder blodet for at forhindre blodpropper (f.eks. warfarin) - dopaminerge lægemidler, inklusive antipsykotika 
- Medicines for depression, including amitriptyline, imipramine and fluoxetine, paroxetine - Medicines for epilepsy (anticonvulsants) (e.g. phenobarbital, phenytoin, primidone, etc) - medicines that thin the blood to prevent blood clots (blood thinners, e.g. warfarin) - dopaminergic drugs, including antipsychotics
Equasym Tabletten 
Equasym tablet
Indehaverne af markedsføringstilladelserne vil indsende resultat når disse foreligger. 
The MAHs will submit the resukts for assessment when available.
Analyser af data fra kliniske studier med methylphenidat hos børn og unge med A patienter, som anvendte methylphenidat oftere oplever ændringer i diastolisk over 10 mmHg i forhold til kontrolgruppen. 
Analyses of data from clinical trials of methylphenidate in children and adolescents with ADHD showed that patients using methylphenidate may commonly experience changes in diastolic and systolic blood pressure of over 10 mmHg relative to controls.
BE - Belgien JANSSEN CILAG Roderveldlaan, 
BE - Belgium JANSSEN CILAG N.V. Roderveldlaan, 1
Fremkomst af nye psykotiske eller maniske symptomer Fremkomst af behandlingsrelaterede psykotiske symptomer (visuelle/taktile/auditive hallucinationer og vrangforestillinger) eller mani hos børn og unge uden psykotisk sygdom eller mani i anamnesen, 
Emergence of new psychotic or manic symptoms Treatment-emergent psychotic symptoms (visual/tactile/auditory hallucinations and delusions) or mania in children and adolescents without prior history of psychotic illness or mania can be caused by methylphenidate at usual doses.
2.1 Risiko for hjertekarsygdomme 
2.1 Cardiovascular risk
CHMP anmodede desuden om, at man i fremtiden antog en konsekvent og struktureret tilg af sikkerhedsoplysningerne i PSUR-rapporterne (Periodic Safety Update Reports) risikostyringsplanerne. 
The CHMP also requested that a consistent and structured approach is taken in the future for the assessment of the safety information in the Period Safety Assessment Reports (PSURs) and the Risk Management Plans.
• Diagnosticeret alvorlig depression eller anamnese med alvorlig depres anoreksi/anorektiske lidelser, selvmordstendenser, psykotiske symptom stemningsforstyrrelser, mani, skizofreni, psykopatisk/borderline personlighe 
• Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
Pludselig død og forudeksisterende strukturelle misdannelser i hjertet eller and hjertesygdomme 
Sudden death and pre-existing cardiac structural abnormalities or other serious cardiac disorders
Behandling med methylphenidat behøver ikke at være på ubestemt tid. 
Methylphenidate treatment does not need to be indefinite.
I opfølgningsperioden på 5 å særligt fokus på dette er en ikke-interventionsundersøgelse, har indehaverne af markedsføringstilladelserne ingen kontrol over det faktiske ordinationsmønster. 
Because this is a noninterventional study, the MAH's will have no control over actual prescribing practices.
Westfalen, Tyskland drhein 
Westfalen, Germany
Novartis Farma - Produto Farmacêuticos, S.A. - Rua do Empresarial - Edifício 8 - Quin Beloura - 2710-444 Sintra s 
Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial - Edifício 8 - Quinta da Beloura - 2710-444 Sintra
Behandling med methylphenidat må kun indledes af og anvendes under over specialist i adfærdsforstyrrelser hos børn og/eller unge. 
Methylphenidate must only be initiated by, and used under the supervision of, a specialist in childhood and/or adolescent behavioural disorders
nktion tagne trækninger i en hvilken som helst del af re at kontrollere) - ser, hører eller føler ting, som ikke er der (hallucinationer) - tror ting, som ikke er sande (vrangforestillinger) - er usædvanligt mistænksom (paranoia) - oplever svingninger i stemningslejet som tankemylder eller impulsive tanker efterfulgt af irritabilitet eller trækker sig ind i sig selv emotionelt og socialt - har selvmordstanker eller -handlinger - føler sig deprimeret eller skyldig - føler sig urolig, angst eller anspændt - oplever ny eller forværret aggressiv eller fjendtlig adfærd. 
- has motion or verbal tics (hard-to-control, repeated twitching of any parts of the body or repeated sounds and words) - is seeing, hearing or feeling things that are not there (hallucinations) - believes things that are not true (delusions) - feels unusually suspicious (paranoia) - experiences mood swings such as racing or impulsive thoughts followed by feeling irritable or emotionally and socially withdrawn - has suicidal thoughts or actions - feels depressed or guilty - feels agitated, anxious or tense - experiences new or worsening aggressive or hostile behaviour
De afsluttede kliniske undersøgelser viste en række konklusioner om virk på vækst og kønsmodning. 
The completed clinical studies presented a range of conclusions on the effects of methylphenidate on growth and sexual maturation.
Kronisk misbrug af methylphenidat kan medføre udtalt tolerance og psykisk afhæn varierende grad af anormal a forbindelse med parenteralt misbrug. 
Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.
Den 22. juni 2007 indbragte Europa-Kommissionen en sag for CHMP i henhold t 2001/83/EF, med senere tilføjelser, for alle produkter, der indeholder methylphenid Kommissionen v sygdomme og cerebrovaskulære sygdomme, i forbindelse med behandling me tages op til vurdering. 
On 22 June 2007, the European Commission requested a referral to the CHMP under Article 31 of Directive 2001/83/EC, as amended, for all methylphenidate containing products.