natgillin/translations-raw huggingface dataset:
Det primære fokus i sikkerhedsvurderingen i denne procedure er på følgende problemer, som muligvis dling med methylphenidat: Risiko for hjerte-kar-sygdomme, risiko for cerebrovaskulære sy carcinogenicitet, virkning på kropsvækst og it. 
The safety evaluation of this procedure is mainly focussed on the following concerns potentially associated with methylphenidate treatment: cardiovascular risks, cerebrovascular risks, psychiatric disorders, carcinogenicity, effect on growth and effects of long term treatment.
2300 København S Danmark 
2300 Köbenhavn S Denmark
De samlede data om risiko for hjerte-kar-sygdomme fra alle de kliniske undersøgelser med produkter, der indeholder methylphenidat, viste, at de hyppigst indberettede hjerte-kar-hændelser var hypertension, øget hjertefrekvens og hjertearytmi (overvejende takykardi). 
Overall, the data relating to cardiovascular risks from all clinical trials of methylphenidate-containing products showed that the events of hypertension, heart rate increases or arrhythmias (mainly tachycardia) and QT prolongation were the main cardiovascular events reported.
De igangværende undersøgelse kønsmodning bør udmønte sig i brugbare resultater om de eventuelle mulige ri 
The ongoing Studies on growth, and on sexual maturation should provide valid data on those possible risks.
Patienter, som får symptomer såsom palp brystsmerter udløst af anstrengelse, uforklarlig besvimelse, dyspnø eller andre sym edeværelsen af ese eller sygdom, foretages itationer, ptomer, der tyder på hjertesygdom under behandling med methylphenidat, skal omgående have hjertet undersøgt af en 
Patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea or other symptoms suggestive of cardiac disease during methylphenidate treatment should undergo a prompt specialist cardiac evaluation.
CRIT124D2201 “An open label, behavioural treatment controlled evaluation of the effects of extended release methylphenidate (Ritalin LA) on the frequency of cytogenetic abnormalities ntrolleret ylphenidat (Ritalin r af ADHD gsplanen og, hvor det er spejler resultaterne af 
Study CRIT124D2201 “An open label, behavioural treatment controlled evaluation of the effects of extended release methylphenidate (Ritalin LA) on the frequency of cytogenetic abnormalities in children 6-12 years old with attention deficit hyperactivity disorder”.
ADHD optræder ofte sammen med andre (komorbide) lidelser såsom adfærdsforstyrrelse, udviklingsforstyrrelse af skolefærdigheder, angst, depressi syndrom. 
ADHD often occurs along with other (co-morbid) disorders such as oppositional defiant and conduct disorders, learning disorders, anxiety, depression, tic disorders and Tourette's syndrome.
Nyre- eller leverinsufficiens Der er ingen erfaring med anvendelse af methylphenidat hos patienter med nyre - eller leverinsufficiens. 
Renal or hepatic insufficiency There is no experience with the use of methylphenidate in patients with renal or hepatic insufficiency.
Methylphenidat bør ikke anvendes hos ældre. 
Methylphenidate should not be used in the elderly.
Metsanneidonkuja 10, , FI-02130 Espoo, Finland, 
LV - Latvia Novartis Finland Oy, Metsanneidonkuja 10, , FI-02130 Espoo, Finland,
Farmakokinetisk interaktion 
Pharmacodynamic interactions
Der er forskelle på de forskellige produkters tilgænge produktoplysninger i de forskellige MS. 
Heterogeneity exists in both the availability of the different products across MS and among the product information between products.
JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENU Tel: +30-210-6140061 
EL - Greece JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel: +30-210-6140061
monitoreres for udvikling eller forværring af tics under behandling med methylphenidat. 
Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate.
• Glaukom 
• Glaucoma
Familieanamnese s vurdering af tics eller Tourettes syndrom hos børn skal gå forud for brugen af methy Patienterne bør regelmæssigt ller verbale tics. 
Family history should be assessed and clinical evaluation for tics or Tourette's syndrome in children should precede use of methylphenidate.
Der kræves omhyggelig overvågning ved seponering, da dette både kan afsløre depression såvel som kronisk hyperaktivitet. 
Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity.
De fleste cerebrovaskulære h var relateret til migræne, hvor der sås rhold til gruppen, som fik er i forbindelse med ata efter en højere incidens i gruppen, som fik behandling med methylphenidat, i fo placebo. 
Most cerebrovascular events from clinical trials were of migraine, with a higher incidence rate in methylphenidate-treated group compared with placebo group.
UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24 Irland 
IE - Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24
Patienter bør informeres om, at {Produktnavn} skal synkes hel en er indeholdt i en ikked. 
Patients should be informed that {Invented name} must be swallowed whole with the aid of liquids.
Derfor er det nødvendigt, at produktinfo og at de ordinerende læger f ordinerede læger. 
Therefore strengthening the Product Information and giving guidance to prescribers on the correct use is necessary.
- CHMP vurderede alle de tilgængelige indsendte data om sikkerheden a indeholder methylphenidat. 
- The Committee considered all the available data submitted on the safety of the methylphenidate containing products.
11.56 mg Tabletter 
11.56 mg Tablet
BILAG III ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL 
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
En diagnose skal foretages i overensstemmelse med DSM IV-kriterier eller retningslinjerne i ten. 
Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient.
Janssen-Cilag Oy Metsänneido 02130 Espoo FINLAND 
FI - Finland Janssen-Cilag Oy Metsänneidonkuja 8 02130 Espoo FINLAND
29 "Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate isticeret med ADHD t eller Adderal)" ed FDA. 
Study NCT 00341029 “Measurement of Cytogenetic Endpoints in Lymphocytes of Children Diagnosed With Attention Deficit/Hyperactivity Disorder (ADHD) and Treated With Methylphenidate or Adderall”, carried out by US National Institute of Environmental Health Sciences in collaboration with FDA.
Sikkerheden ved brug af produkter, der indeholder methylphenidat, under graviditet og amning er blevet vurderet af CHMP og yderligere drøftet i arbejdsgruppen vedrørende sikkerhed (SWP) i esuméet er ændret i ilgængelige beretninger og ling af børn, men tidsbehandling, 
The safety of the use of methylphenidate containing products during pregnancy and lactation has been assessed by the CHMP and further discussed in the Safety Working Party (SWP) in December 2008.
Det er et amfetaminlignende gruppen af morfica, hvilket medfører strenge restriktioner på ordination og hånd 
It is an amphetamine-like drug that has controlled drug status, which imposes restrictions on prescribing and handling.
Der kan forekomme regulære psykotiske episoder, især i 
Frank psychotic episodes can occur, especially in response to parenteral abuse.
Derudover har indehaverne af markedsføringstilladelserne, ef CHMP, indvilliget i at gennemføre undersøgelser af lægemiddelbrug (DUS) i for at undersøge graden af misbrug. 
In addition the MAHs have committed to perform drug utilisation studies (DUS) in all EU MS to investigate the level of misuse, as requested by the CHMP.
Det skal besluttes, om amning skal ophøre, eller om man skal seponere/undlade methylphenidat ved at behandling med medtænke fordelene ved amning for barnet og vigtighed af behandling med askiner e føre motorkøretøj eller betjene maskiner. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Sandoz A/S ns Boulev 
Sandoz A/S C.F. Tietgens Boulevard 40
; Raa 1; 6824 DP ARNHEM/NL 
Novartis Pharma B.V.; Raapopseweg 1; 6824 DP ARNHEM/NL
Patienter med sjældne arvelige problemer galactose med intolerans, Lapp lactasemangel eller glucose-galactosemalabsorption bør ikke tage dette 
This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN 
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Der var ikke noget entydigt mønster i de indsendte data med hensyn til dosis eller symptomdebut. 
There was no consistent pattern of dosage or time-to-onset from the submitted data.
Almindelig: svimmelhed, dyskinesi, psykomotorisk hyperaktivitet, døsighed Ikke almindelig: sløvhed, rystelser 
Common: dizziness, dyskinesia, psychomotor hyperactivity, somnolence Uncommon: sedation, tremor
e EU-baserede data, indeholde kommentarer til, en af muligheden for at else med markedsføringstilladelserne påtaget reslåede opfølgningsperiode på mindst 5 år for r vil der blive lagt vurdering af virkningerne af en kumulativ eksponering på mindst 18 måneder. 
Within the 5-year follow-up, particular emphasis will be placed on assessing the effects of a cumulative exposure of at least 18 months.
Hvis operationen e methylphenidat ikke anvendes på operationsdagen. 
If surgery is planned, methylphenidate treatment should not be used on the day of surgery.
Almindelig: anoreksi, affektlabilitet, aggression*, uro*, angst*, depression*, irritabilitet, unormal berøringshallucinationer*, vrede, 
Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Uddannelsesværktøjer risikominimeringsværktøjer, som indeholder alle de vigtige oplysninger, der findes under punktet Kliniske oplysninger i kernepunkterne i produktresuméet: 
The MAHs will produce fully harmonised Risk Minimisation tools that contain all of the important information from the Clinical Particulars section of the Core SPC.
Der bør udvises særlig forsigtighed ved brug af methylphenidat til behandling af ADHD hos patienter med komorbid bipolar sygdom (inklusive ubehandlet Type I bipolar sindslidelse eller andre former for bipolare sygdomme). 
Particular care should be taken in using methylphenidate to treat ADHD in patients with comorbid bipolar disorder (including untreated Type I Bipolar Disorder or other forms of bipolar disorder) because of concern for possible precipitation of a mixed/manic episode in such patients.
vende methylphenidat i lange perioder (over 12 måneder) til børn og unge med ADHD, bør periodisk revurdere det langvarige udbytte af lægemidlet for den enkelte patient. 
The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the drug for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy.
Ratiopharm GmbH, Graf-Ar 3, D 
IE - Ireland Ratiopharm GmbH, Graf-Arco-Strasse 3, D
I de kliniske undersøgelser med børn, blev der ikke indberettet hændels andre cerebrovaskulære sygdomme. 
No events related to other cerebrovascular disorders were reported in children from clinical trials.
Methylphenidat har en veldokumenteret virkning på blodtryk og hjertefrekvens (øget puls, øget produktinformationen). 
Methylphenidate has a well-documented effect on blood pressure and heart rate (increased pulse rate, increased blood pressure and tachycardia are recognised adverse events of methylphenidate and are listed in the product information).
Methylphenidat er ikke godkendt til brug hos voksne med ADHD. 
Methylphenidate is not licensed for use in adults with ADHD.
Hvis du e methylphenidat i mere end et år, bør lægen stoppe behandlingen med methylphe en gang med at se en fordel, når methylphenidat stoppes enten midlertidigt eller permanent. 
If methylphenidate is taken for more than a year, your doctor should stop your treatment with methylphenidate for a short time once a year to see if the medicine is still needed.
Cerebrovaskul ære sygdomme* (herunder vaskulitis, cerebral hæmorrhage og cerebrovaskul ære hændelser, cerebral arteritis, cerebral okklusion), grand mal kramper*, migræne 
Not known: cerebrovascular disorders* (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsions*, migraine
eg 30 B-2340 Beerse 
B-2340 Beerse
Det anbefales, at methylphenidat afbrydes mindst én gang årligt for at vurdere barnets tilstand (hels Forbedringer kan vare ved, når lægem 
It is recommended that methylphenidate is de-challenged at least once yearly to assess the child's condition (preferable during times of school holidays).
92500 Rueil-Malmaison Frankrig ed modificeret 
92500 Rueil-Malmaison France
• maniske episoder 
• mania
Registreringsstatussen for de forskellige lægemidler, der indeholder methylphenidat, er den samme i lighed og 
The regulatory status of the different Methylphenidate containing medicinal products is heterogeneous across EU Member States (MS).
For nogle børn kan behandling med mmen med andre former for ikke-medicinsk behandling, reducere symptomerne på i ungdommen og iale problemer, 
For some of these children, methylphenidate treatment, along with other forms of non-medical treatment can reduce symptoms of hyperactivity and improve quality of life.
Methylphenidat anvendes som en del af et omfattende behandlingsprogram for sygd (Attention-deficit hyperactivity disorder) til børn over 6 år, når afhjælpende tiltag a utilstrækkelige. 
Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient.
I de prækliniske undersøgelser var der ingen indberetninger om denne risiko. 
2.2 Cerebrovascular risk There was no evidence reported from pre-clinical studies in relation to this risk.
Alkohol 
Use with alcohol
Janssen-Cilag s.r.o., Karla 3201/6, 150 00 Praha 5 - S 
Janssen-Cilag s.r.o., Karla Engliše 3201/6, 150 00 Praha 5 - Smíchov, Czech Republic
Patienter, som er i betragtning til behandling med stimulerende lægemidler, skal have udført en detaljeret anamnese (herunder vurdering af familieanamnese i forhold til pludselig hjertedød eller uforklarlig død eller malign arytmi) samt en fysisk undersøgelse, for at vurdere tilst hjertesygdom. 
Patients who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden cardiac or unexplained death or malignant arrhythmia,) and physical exam to assess for the presence of cardiac disease, and should receive further specialist cardiac evaluation if initial findings suggest such history or disease.
Endelig accepteres det, at der med hensyn til kardiovaskulære risici findes en poten anmodede CHMP om en skærpelse af produktinformationen, så den kom til at omfa evaluering før behandling af patienterne og om screening og overvågning under b produkter (se bilag III). 
For that reason the CHMP requested strengthening of the Product Information giving advice on pre-treatment evaluation of the patients and on going screening and monitoring during the treatment with these products (see Annex III).
Ikke almindelig: forhøjet leverenzymtal Meget sjælden: unormal leverfunktion, inklusive leverkoma 
Uncommon: hepatic enzyme elevations Very rare: abnormal liver function, including hepatic coma
vis du eller dit barn tager anden medicin, kan m edicins virkning eller kan give bivirkninger. 
If you or your child is taking other medicines, methylphenidate may affect how well other medicines work or may cause side effects.
om den samlede anvendte mængde, patientalder, køn, indikationsdosis, varighed af b behandlingskontinuitet, komorbiditete 
Where possible, measures of usage including variables such as information on total amount used, patient age, gender, indication dose, duration of use, treatment continuity, comorbidities, concomitant medications, data on patterns of use, physician specialty will be used.
• Blodtryk og puls skal kontrolleres og anføres på en percentil kurve ved hver dosisjustereing og efterfølgende minimum hver 6. måned; 
• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
Monitorering bør forekomme ved hver dosisjustering og efterfølgende minimum hver 6. måned eller ved hver konsultation. 
Monitoring should be at every adjustment of dose and then at least every 6 months or every visit.
Methylphenidat kan sænke ed tidligere anormale r uden anfald og i sjældne tilfælde uden anfald og anormale EEG-værdier i anamnesen. 
Methylphenidate may lower the convulsive threshold in patient with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and rarely in patients without a history of convulsions and no EEG abnormalities.
Ikke almindelig: muskelsmerter, muskeltrækninger Meget sjælden: muskelkramper 
Uncommon: myalgia, muscle twitching Very rare: muscle cramps
Halogenerende anæstetika 
Use with halogenated anaesthetics
Almindelig: ændringer i blodtryk og hjerterytme (normalt en stigning)*, vægttab* Ikke almindelig: hjertemislyd*, øget leverenzymtal at antal blodplader, 
Common: changes in blood pressure and heart rate (usually an increase)*, weight decreased* Uncommon: cardiac murmur*, hepatic enzyme increased Very rare: blood alkaline phosphatase increased, blood bilirubin increased, platelet count decreased, white blood count abnormal
Psykiatriske virkninger af risikoen for suicidalitet i forbindelse med brug af methylphenidat til børn baggrund af de kliniske data for methylphenidat, som i øjeblikket er tilgængelige markedsføringstilladelserne. 
The MAHs will investigate the feasibility of carrying out a meta-analysis of the risk of suicidality associated with the use of methylphenidate in children and adolescents with ADHD on the basis of the clinical trial data of methylphenidate that is currently available to the MAHs.
Medicin absorberende skal, som er designet til at afgive stoffet ved en kontrolleret hastighe elimineres fra kroppen; patienter bør ikke blive bekymred noget i deres afføring, der ligner en tablet. 
The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Janssen-Cilag Farmacêutica, Ld Estrada Consiglieri Pedroso Queluz de Baixo - 2734-503 
Janssen-Cilag Farmacêutica, Lda.Estrada Consiglieri Pedroso, 69 AQueluz de Baixo - 2734-503 Barcarena
- har meget højt blodtryk eller karforsnævringer, som muligvis giver smerter i arme og ben ler vaskulære rebral vaskulitis. 
- have a very high blood pressure or narrowing of the vessels, possibly resulting in pain in the arms and legs - has experienced a cerebrovascular disorder such as stroke, cerebral aneurysm, or vascular abnormalities including cerebral vasculitis
Akut overdosering, hovedsageligt på grund af overstimulering af det centrale og sy nervesystem, kan resultere i opkastning, agitation, tremor, hyperrefleksi, muskeltræk (eventuelt efterfulgt af koma), eufori, konfusion, hallucinationer, delirium, svedtendens, rødm mpatiske ninger, kramper en, hovedpine, hyperpyreksi, takykardi, palpitationer, hjertearytmier, hypertension, mydriasis og tørhed af er. 
Acute overdose, mainly due to overstimulation of the central and sympathetic nervous systems, may result in vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia,
Aggressiv eller fjendtlig adfærd Fremkomsten eller forværringen af aggression eller fjendtlighed kan skyldes behandling med for udvikling eller t, ved hver dosisjustering og rdere, om der er r i adfærd. 
The emergence or worsening of aggression or hostility can be caused by treatment with stimulants.
Langvarig brug (over 12 måneder) til børn og unge Sikkerheden og virkningen ved langvarig brug af methylphenidat er ikke blevet evalu kontrollerede studier. 
Long-term use (more than 12 months) in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Alfred Tiefenbacher (Gmb KG); Van-der-Smisse- St 22767 HAMBURG/ Tyskla 
Alfred Tiefenbacher (GmbH & Co. KG); Van-der-Smisse- Strasse 1; 22767 HAMBURG/ Germany
10 mg - Tabletter 20, 30, 40 mg - Kapsler med modificeret udløsning, hårde 
10 mg - tablet 20, 30, 40 mg - modifiedrelease capsule, hard
Tegn på en overdosis kan være: opkastning, uro, ryst muskeltrækninger, krampeanfald (kan følges af koma), følelse af ekstrem lykke, forvirring) hallucinationer (se, føle eller høre ting, som ikke er virkelige), svedafsondring, rødm uregelmæssig), højt blodtryk, udvidede pupiller, tørhed i 
Signs of overdose may include: vomiting, agitation, shaking, increased uncontrolled movements, muscle twitching, fits (may be followed by coma), feeling of extreme happiness, confusion (severe confusion), hallucinations (seeing, feeling or hearing things that are not real), sweating, flushing, headache, high fever, changes in heart beat (slow, fast or irregular), high blood pressure, dilated pupils and dry nose and mouth.
Selvom de forelagte data antydede, at disse virkninger hos de fleste patienter er rev seponering af behandlingen, foreligger der utilstrækkelige veldokum ethylphenidats virkning på blodtryk konsekvenser af disse virkninger på hjerte-kar-systemet. 
Although the data provided suggested that in most patients, these effects are reversible upon discontinuation, there is a lack of reliable data regarding the extent of the effect of methylphenidate on blood pressure and heart rate and also on the long-term effects or clinical consequences on the cardiovascular system of these effects.
Langvarig (længere end 12 måneders) anvendelse til børn og unge Sikkerheden og virkningen ved langvarig anvendelse af methylphenidat er ikke system atisk undersøgt i kontrollerede forsøg. 
Long-term (more than 12 months) use in children and adolescents The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials.
Der skal sørges for intensiv pleje for at opretholde tilstrækkelig cirkulation og respiration. 
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Hvis der forek maniske symptomer, bør en mulig årsagssammenhæng med methylphenidat overve af behandlingen kan være relevant. 
If manic or psychotic symptoms occur, consideration should be given to a possible causal role for methylphenidate, and discontinuation of treatment may be appropriate.
Janssen Cilag N.V./S.A Roderv 1, B- 2600 Berchem eldlaan r 
Janssen Cilag N.V./S.A Roderveldlaan 1, B- 2600 Berchem
Indlæringsevnen kan muligvis være eller flere symptomer. 
Learning may or may not be impaired.
• Forudeksisterende kardiovaskulære lidels okklusiv sygdom, angina pectoris, hæmodynamisk signifikant medfødt hjerte kardiomyopatier, myokardie (sygdomme som skyldes dysfunktion af ionkanaler). 
• pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels).
MT - Malta UCB Pharma Limited, 208, Bath Road, Slough, Berkshire SL1 3WE Det Forenede Kongerige 
MT - Malta UCB Pharma Limited, 208, Bath Road, Slough, Berkshire SL1 3WE United Kingdom