FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Methylphenidate is not metabolised by cytochrome P450 to a clinically relevant extent.
Danish: Methylphenidat metaboliseres ikke i klinisk relevant grad af cytochrom P450.
English: Janssen-Cilag B.V.; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
Danish: ; Dr. Paul Janssenweg 150 ; 5026 RH TILBURG/NL
English: Very rare: Anaemia, leukopenia, thrombocytopenia, thrombocytopenic purpura Unknown: Pancytopenia
Danish: Meget sjælden: Anæmi, leukopeni, trombocytopeni, trombocytopenisk purpura Ikke kendt: Pancytopeni
English: Very rare: sudden cardiac death*
Danish: Pludselig hjertedød*
English: The MAHs should closely monitor reports of cyanosis in future PSURs, including them as terms for targeted follow-up.
Danish: Indehaverne af markedsføringstilladelserne skal nøje overvåge indberetninger om cyanose i fremtidige PSUR-rapporter og medtage dem under reaktioner, der skal følges op på.
English: Treatment with methylphenidate is not contraindicated in patients with hemiplegic cerebral palsy
Danish: Behandling med methylphenidat er ikke kontraindiceret hos patienter med hemiplegisk cerebral lammelse.
English: • Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not wellcontrolled)
Danish: • Diagnosticeret alvorlig episodisk (Type I) bipolar (affektiv) sindslidelse (som velkontrolleret) eller anamnese med alvorlig episodisk (Type I) bipolar (affek (som ikke er velkontrolleret)
English: 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.
Danish: Der bør udvises forsigtigh ustabile patienter, såsom patienter med stof- eller alkoholafhæ kan øge doseringen på eget initiativ.
English: The MAHs should harmonise the relevant wording of the Package Leaflet by reflecting the changes proposed in the SPC.
Danish: Indehaverne skal harmonisere den relevante ordlyd i indlægssedlen, så den afspejler de foreslåede
English: Furthermore, the MAHs committed to investigate the long term effect on children's development.
Danish: Indehaverne af markedsføringstilladelserne har også indvilliget i at undersøge langtidsvirkningen på udviklingen hos børn.
English: 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
Danish: Indehaverne af markedsføringstilladelserne skal i risikostyringsplanen løbende evaluere nyligt identificerede eller potentielle risici, eller nye/vigtige oplysninger om eksisterende identificerede eller potentielle risici.
English: A currently ongoing cytogenicity study may give responses when finalised.
Danish: Når en igangværende cytogenicitetsundersøgel muligvis besvares.
English: 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).
Danish: 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).
English: • about any other medical conditions (such as heart conditions) you, your child or you family may have.
Danish: • eventuelle andre medicinske lidelser (for eksempel hjertelidelser), som familie har
English: ES - Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 Madrid
Danish: ES - Spanien JANSSEN CILAG, SA Paseo de las doce estrellas , 5-7
English: Therefore, your doctor will decide whether you or your daughter should breast-feed while using methylphenidate.
Danish: Derfor beslutter lægen, om du eller din datter bør amme under indtagelsen af methylphenidat.
English: 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.
Danish: Selvom de fleste indberetninger om var antallet af indberetninger fra voksne højere end forventet (i de tilfælde, h med hensyn til centrale bivirkninger.
English: Tel:+34-93-772 25 09
Danish: Tel:+34-93-772 25 09 Fax: +34-93-772 25 01
English: In life-time rat and mouse carcinogenicity studies, increased numbers of malignant liver tumours were noted in male mice only.
Danish: I livstidsstudier af karcinogenicitet i rotter og mus, sås øget forekomst af maligne levertumorer hos hanmus.
English: Growth should be monitored during methylphenidate treatment: height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart.
Danish: ør monitoreres under behandling med methylphenidat: højde, vægt og appetit skal trolleres minimum hver 6. måned og anføres fortløbende på en vækstkurve.
English: Your doctor may decide you or your child need other medical tests before you or your child take this medicine.
Danish: Din l andre medicinske test, før du eller dit barn tager denne medicin.
English: 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.
Danish: 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.
English: DK - Denmark Janssen-Cilag A/S Hammerbakken 19
Danish: DK - Danmark Janssen-Cilag A/S Hammerbakken 19
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The MAHs have committed to distribute education material for guidance of the prescribers.
Danish: Indehaverne af arkedsføringstilladelserne har indvilliget i at distribuere uddannelsesmateriale, der skal vejlede de ter anmodning fra alle EU-medlemsstater
English: Safety and efficacy in this age group has not been established.
Danish: Sikkerhed og virkning hos denne aldersgruppe er ikke fastlagt.
English: 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:
Danish: For at din læge kan beslutte, om methylphenidat er lægen drøfte følgende med dig:
English: Treatment There is no specific antidote to methylphenidate overdosage.
Danish: Der er ingen specifik antidot ved overdosering med methylphenidat.
English: 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.
Danish: 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
English: There is limited information that suggests that methylphenidate is passed into human breast milk.
Danish: Der er begrænset information, som tyder på, a methylphenidat udskilles i modermælk.
English: 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.
Danish: 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.
English: 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.
Danish: 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
English: - 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.
Danish: - CHMP konkluderede, at produktinformationen for alle produkter indeholde skal indeholde de samme sikkerhedsoplysninger, og udvalget anbefalede de de relevante afsnit i p
English: Therefore, caution is recommended at combining methylphenidate with other drugs, especially those with a narrow therapeutic window.
Danish: Forsigtighed anbefales derfor ved samtidig administration a idler, som f methylphenidat og andre lægemidler, især lægemidler med et smalt terapeutisk vindue.
English: <Always <take> <use> methylphenidate exactly as your doctor has told you.
Danish: <Tag/brug altid methylphenidat nøjagtigt efter lægens anvisning.
English: Other strengths of this medicinal product and other methylphenidate-containing products may be available.
Danish: Der findes muligvis andre styrker af dette lægemiddel og and methylphenidat.
English: The literature is conflicting with regards to the effects of methylphenidate on growth and sexual maturation.
Danish: I litteraturen er der modstridende oplysni af methylphenidat på vækst og kønsmodning.
English: 2.8 Pregancy and lactation
Danish: 2.8 Graviditet og amning
English: Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Danish: idlet seponeres enten midlertidigt eller permanent.
English: Careful dose titration is necessary at the start of treatment with methylphenidate.
Danish: Det er nødvendigt omhyggeligt at titrere dosen ved starten af behandling med methylphenidat.
English: HU - Hungary Novartis Hungária Kft.Pharma 1114 Budapest
Danish: HU - Ungarn Novartis Hungária Kft.Pharma 1114 Budapest
English: DE - Germany ratiopharm GmbH D-89070 Ulm
Danish: Tabletten d ratiopharm GmbH D-89070 Ulm
English: See section 4.3 for cerebrovascular conditions in which methylphenidate treatment in contraindicated.
Danish: 4.3 for cerebrovaskulære tilstande hvor methylphenidat er kontraindiceret.
English: 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.
Danish: 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.
English: 2100 Københarn Ø Denmark
Danish: 2100 København Ø Danmark
English: Anti-hypertensive drugs Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.
Danish: Antihypertensive lægemidler tte virkningen af lægemidler, som anvendes til behandling af hypertension.
English: Methylphenidate treatment should not and need not, be indefinite.
Danish: Behandling med methylphenidat bør ikke og behøver ikke være ubegrænset.
English: Novartis Pharma Roonstrasse 25 90429 Nűrnberg Germany
Danish: Novartis Ph Roonstrasse 90429 N Tyskland
English: FI - Finland UCB Pharma Oy Finland Malminkaari 5 00700 Helsinki FINLAND
Danish: UCB Pharma Oy Finland Malm 5 00700 Helsinki FINLAND
English: Misuse and Cardiovascular Events
Danish: Misbrug og kardiovaskulære bivirkninger
English: CS - Czech Republic
Danish: CS - Den Tjekkiske k ske
English: SE - Sweden Janssen-Cilag AB Box 7073
Danish: Janssen-Cila Box 7073
English: Nervous system disorders
Danish: Nervesystemet adfærd
English: All MAHs are therefore required to add Raynaud's phenomenon to their Product Information (PI) for all methylphenidate-containing products.
Danish: Alle inde markedsføringstilladelserne skal derfor føje Reynauds fænomen til deres pr alle produkter, der indeholder methylphenidat.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: 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.
English: Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician.
Danish: Patienter, som får tanker om selvmord eller udviser selvmordsadfærd under beha skal straks vurderes af lægen.
English: • Assessing psychiatric symptoms, each time your dose in changed and then at least every six months or at every visit.
Danish: • Bedømmelse af psykiatriske symptomer, hver gang dosis ændres og derefter mindst hver sjette måned eller ved hvert besøg.
English: - 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
Danish: 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
English: Equasym tablet
Danish: Equasym Tabletten
English: The MAHs will submit the resukts for assessment when available.
Danish: Indehaverne af markedsføringstilladelserne vil indsende resultat når disse foreligger.
English: 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.
Danish: 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.
English: BE - Belgium JANSSEN CILAG N.V. Roderveldlaan, 1
Danish: BE - Belgien JANSSEN CILAG Roderveldlaan,
English: 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.
Danish: 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,
English: 2.1 Cardiovascular risk
Danish: 2.1 Risiko for hjertekarsygdomme
English: 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.
Danish: CHMP anmodede desuden om, at man i fremtiden antog en konsekvent og struktureret tilg af sikkerhedsoplysningerne i PSUR-rapporterne (Periodic Safety Update Reports) risikostyringsplanerne.
English: • Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
Danish: • Diagnosticeret alvorlig depression eller anamnese med alvorlig depres anoreksi/anorektiske lidelser, selvmordstendenser, psykotiske symptom stemningsforstyrrelser, mani, skizofreni, psykopatisk/borderline personlighe
English: Sudden death and pre-existing cardiac structural abnormalities or other serious cardiac disorders
Danish: Pludselig død og forudeksisterende strukturelle misdannelser i hjertet eller and hjertesygdomme
English: Methylphenidate treatment does not need to be indefinite.
Danish: Behandling med methylphenidat behøver ikke at være på ubestemt tid.
English: Because this is a noninterventional study, the MAH's will have no control over actual prescribing practices.
Danish: I opfølgningsperioden på 5 å særligt fokus på dette er en ikke-interventionsundersøgelse, har indehaverne af markedsføringstilladelserne ingen kontrol over det faktiske ordinationsmønster.
English: Westfalen, Germany
Danish: Westfalen, Tyskland drhein
English: Novartis Farma - Produtos Farmacêuticos, S.A. - Rua do Centro Empresarial - Edifício 8 - Quinta da Beloura - 2710-444 Sintra
Danish: Novartis Farma - Produto Farmacêuticos, S.A. - Rua do Empresarial - Edifício 8 - Quin Beloura - 2710-444 Sintra s
English: Methylphenidate must only be initiated by, and used under the supervision of, a specialist in childhood and/or adolescent behavioural disorders
Danish: Behandling med methylphenidat må kun indledes af og anvendes under over specialist i adfærdsforstyrrelser hos børn og/eller unge.
English: - 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
Danish: 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.
English: The completed clinical studies presented a range of conclusions on the effects of methylphenidate on growth and sexual maturation.
Danish: De afsluttede kliniske undersøgelser viste en række konklusioner om virk på vækst og kønsmodning.
English: Chronic abuse of methylphenidate can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.
Danish: Kronisk misbrug af methylphenidat kan medføre udtalt tolerance og psykisk afhæn varierende grad af anormal a forbindelse med parenteralt misbrug.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 2300 Köbenhavn S Denmark
Danish: 2300 København S Danmark
English: 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.
Danish: 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).
English: The ongoing Studies on growth, and on sexual maturation should provide valid data on those possible risks.
Danish: De igangværende undersøgelse kønsmodning bør udmønte sig i brugbare resultater om de eventuelle mulige ri
English: 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.
Danish: 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
English: 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”.
Danish: 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
English: 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.
Danish: ADHD optræder ofte sammen med andre (komorbide) lidelser såsom adfærdsforstyrrelse, udviklingsforstyrrelse af skolefærdigheder, angst, depressi syndrom.
English: Renal or hepatic insufficiency There is no experience with the use of methylphenidate in patients with renal or hepatic insufficiency.
Danish: Nyre- eller leverinsufficiens Der er ingen erfaring med anvendelse af methylphenidat hos patienter med nyre - eller leverinsufficiens.
English: Methylphenidate should not be used in the elderly.
Danish: Methylphenidat bør ikke anvendes hos ældre.
English: IS Iceland
Danish: IS - Island
English: LV - Latvia Novartis Finland Oy, Metsanneidonkuja 10, , FI-02130 Espoo, Finland,
Danish: Metsanneidonkuja 10, , FI-02130 Espoo, Finland,