natgillin/translations-raw huggingface dataset:
Hvis der er planlagt en operation med halogeneret anæstesi (en bestemt type narkose), må du eller dit barn ikke tage methylphenidat på dagen for operationen på grund af risikoen for en pludselig stigning i blodtrykket under operationen. 
If surgery is planned using a halogenated anaesthetic (a certain type of anaesthetic), you or your child should not take methylphenidate on the day of surgery, due to the risk of a sudden rise in blood pressure during surgery.
• Hyperthyreosis eller tyrotoksikose 
• Hyperthyroidism or Thyrotoxicosis
Indvirkning på vækst og modning 
Effects on growth and maturation
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLERNE FREMLAGT AF EMEA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
De mest almindelige bivirkninger er nervøsitet, søvnløshed og hovedpine. 
The most common side effects are nervousness, sleeplessness and headache.
Når methylphenidat anvendes i en lang periode, kan det hos nogle børn forårsage reduceret vækst (vægtøgning og/eller højde). 
When used for a long period of time, methylphenidate may cause reduced growth (weight gain and/or height) in some children.
I denne videnskabelige vurdering af methylphenidat har man gennemgået de t sikkerhedsdata fra kliniske undersøgelser, prækliniske undersøgelser, spontane ind publiceret litteratur. 
This scientific assessment on methylphenidate has reviewed the available safety data from clinical trials, preclinical studies, spontaneous reports and published literature.
karstatus, vækst, appetit, udvikling af nye eller forværring af tidligere eksisterende psy symptomer. 
or cardiovascular status, growth, appetite, development of de novo or worsening of pre-existing psychiatric symptoms
Meget almindelig: søvnløshed, nervøsitet 
Very common: insomnia, nervousness
41470 Neuss, Ty 
41470 Neuss, Germany
Patienter bør advares om disse mulige bivirkninger og å potentielt farlige aktiviteter, såsom føre motorkøretøj eller betjene maskiner, hvis de påvirkes. 
Patients should be warned of these possible effects and advised that if affected, they should avoid potentially hazardous activities such as driving or operating machinery.
Føtal toksicitet (f.eks. totalt tab af kuld) og maternel toksicitet blev observeret i rotter ved maternelt toksiske doser. 
Foetal toxicity (i.e. total litter loss) and maternal toxicity was noted in rats at maternally toxic doses.
Kardiovaskulær status 
Cardiovascular status
En gennemgang af de tilgængelige data viste, at de mere specifikke udtryk "overfokusering" og "repetetiv adfærd" afspejler de observerede virkninger af methylphenidat og bør tilføjes under bivirkninger i produktinformationen. 
A review of all available data found that the more specific terms “over-focussing” and “repetitive behaviours” reflect the observed effects of methylphenidate and should be added as possible adverse effects in the Product Information.
Produktinformationen (PI) for de fleste af produkterne omfatter nøgleelementer sikkerhedsproblemer ved methylphenidat. 
The product information (PI) of most products contains key elements on the above safety concerns of methylphenidate.
Metabolisme og ernæring* 
Metabolism and nutritional disorders*
MP godkendte ordlyd i indlægssedlen skal revideres, så den bliver mere patientvenlig, hvorefter den skal brugertestes. 
The PL wording agreed by the CHMP should be revised to improve patient readability, and will then be user-tested.
Centralt virkende alfa-2-agonister (f.eks. clonidin) Alvorlige bivirkninger, herunder pludselig død, har været indberettet ved samtidig anvendelse af clonidin. 
Use with centrally acting alpha-2 agonists (e.g. clonidine) Serious, adverse events, including sudden death, have been reported in concomitant use with clonidine.
Graviditet Der foreligger begrænsede data om anvendelsen af methylphenidat hos gravide kvinder. 
Pregnancy There is a limited amount of data from the use of methylphenidate in pregnant women.
Der kræves omhyggelig kontrol under seponering ved misbrug, da der kan opstå alvorlig depression. 
Careful supervision is required during withdrawal from abusive use since severe depression may occur.
Sikkerheden ved anvendelsen af methylphenidat sammen med clonidin o virkende alfa-2-agonister er ikke blevet systematisk undersøgt. 
The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systematically evaluated.
Indehaverne af markedsføringstilladelserne anmodes om at angive en liste med disse reaktioner i PI'en for de produkter, hvor disse oplysninger mangler. 
MAHs are requested to list these terms in the PI for those products where the information is missing.
• om der i familien har været tics (ansigtstrækninger). 
• whether there is a family history of tics
Indehaverne af markedsføringstilladelserne skal i kernepunkterne i deres sikkerhedsspecifikationer inkludere den endelige tabel med identificerede og potentielle risici i henhold til CHMP's krav. 
The MAHs should include, in the core safety specification, the final core table of identified and potential risks as requested by the CHMP.
Methylphenidat kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, methylphenidate can cause side effects, although not everybody gets them.
B-2600 BERCHE 
B-2600 BERCHEM
Med hensyn til suicidalitet har indehaverne af markedsføringstilladelserne indvilliget i at bruge deres nuværende viden og gennemføre en meta-analyse af de tilgængelige resultater fra forskellige kliniske undersøgelser. 
In terms of the suicidality the MAHs committed to make use of the current knowledge and to conduct a meta-analysis on the available results from different clinical studies.
Markedsføringstilladelser for lægemidler indeholdende METHYLPHENIDAT at 
Marketing Authorisations for medicinal products containing METHYLPHENIDATE
Dyrestudier har kun påvist reproduktionstoksicitet ved toksiske doser h 
Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses.
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. 
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.
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. 
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.
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