FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacodynamic interactions
Danish: Farmakokinetisk interaktion
English: Heterogeneity exists in both the availability of the different products across MS and among the product information between products.
Danish: Der er forskelle på de forskellige produkters tilgænge produktoplysninger i de forskellige MS.
English: EL - Greece JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENUE 56, PEFKI, 15121 Tel: +30-210-6140061
Danish: JANSSEN-CILAG PHARMACEUTICAL S.A.C.I EIRINIS AVENU Tel: +30-210-6140061
English: Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate.
Danish: monitoreres for udvikling eller forværring af tics under behandling med methylphenidat.
English: • Glaucoma
Danish: • Glaukom
English: Family history should be assessed and clinical evaluation for tics or Tourette's syndrome in children should precede use of methylphenidate.
Danish: Familieanamnese s vurdering af tics eller Tourettes syndrom hos børn skal gå forud for brugen af methy Patienterne bør regelmæssigt ller verbale tics.
English: Careful supervision is required during drug withdrawal, since this may unmask depression as well as chronic over-activity.
Danish: Der kræves omhyggelig overvågning ved seponering, da dette både kan afsløre depression såvel som kronisk hyperaktivitet.
English: Most cerebrovascular events from clinical trials were of migraine, with a higher incidence rate in methylphenidate-treated group compared with placebo group.
Danish: 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.
English: IE - Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24
Danish: UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road - Dublin 24 Irland
English: Patients should be informed that {Invented name} must be swallowed whole with the aid of liquids.
Danish: Patienter bør informeres om, at {Produktnavn} skal synkes hel en er indeholdt i en ikked.
English: Therefore strengthening the Product Information and giving guidance to prescribers on the correct use is necessary.
Danish: Derfor er det nødvendigt, at produktinfo og at de ordinerende læger f ordinerede læger.
English: - The Committee considered all the available data submitted on the safety of the methylphenidate containing products.
Danish: - CHMP vurderede alle de tilgængelige indsendte data om sikkerheden a indeholder methylphenidat.
English: 11.56 mg Tablet
Danish: 11.56 mg Tabletter
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG III ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: 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.
Danish: En diagnose skal foretages i overensstemmelse med DSM IV-kriterier eller retningslinjerne i ten.
English: FI - Finland Janssen-Cilag Oy Metsänneidonkuja 8 02130 Espoo FINLAND
Danish: Janssen-Cilag Oy Metsänneido 02130 Espoo FINLAND
English: 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.
Danish: 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.
English: 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.
Danish: 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,
English: It is an amphetamine-like drug that has controlled drug status, which imposes restrictions on prescribing and handling.
Danish: Det er et amfetaminlignende gruppen af morfica, hvilket medfører strenge restriktioner på ordination og hånd
English: Frank psychotic episodes can occur, especially in response to parenteral abuse.
Danish: Der kan forekomme regulære psykotiske episoder, især i
English: 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.
Danish: Derudover har indehaverne af markedsføringstilladelserne, ef CHMP, indvilliget i at gennemføre undersøgelser af lægemiddelbrug (DUS) i for at undersøge graden af misbrug.
English: 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.
Danish: 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.
English: Sandoz A/S C.F. Tietgens Boulevard 40
Danish: Sandoz A/S ns Boulev
English: Novartis Pharma B.V.; Raapopseweg 1; 6824 DP ARNHEM/NL
Danish: ; Raa 1; 6824 DP ARNHEM/NL
English: 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.
Danish: Patienter med sjældne arvelige problemer galactose med intolerans, Lapp lactasemangel eller glucose-galactosemalabsorption bør ikke tage dette
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN
English: There was no consistent pattern of dosage or time-to-onset from the submitted data.
Danish: Der var ikke noget entydigt mønster i de indsendte data med hensyn til dosis eller symptomdebut.
English: Common: dizziness, dyskinesia, psychomotor hyperactivity, somnolence Uncommon: sedation, tremor
Danish: Almindelig: svimmelhed, dyskinesi, psykomotorisk hyperaktivitet, døsighed Ikke almindelig: sløvhed, rystelser
English: Within the 5-year follow-up, particular emphasis will be placed on assessing the effects of a cumulative exposure of at least 18 months.
Danish: 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.
English: If surgery is planned, methylphenidate treatment should not be used on the day of surgery.
Danish: Hvis operationen e methylphenidat ikke anvendes på operationsdagen.
English: Common: anorexia, affect lability, aggression*, agitation*, anxiety*, depression*, irritability, abnormal behaviour
Danish: Almindelig: anoreksi, affektlabilitet, aggression*, uro*, angst*, depression*, irritabilitet, unormal berøringshallucinationer*, vrede,
English: 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.
Danish: Uddannelsesværktøjer risikominimeringsværktøjer, som indeholder alle de vigtige oplysninger, der findes under punktet Kliniske oplysninger i kernepunkterne i produktresuméet:
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: IE - Ireland Ratiopharm GmbH, Graf-Arco-Strasse 3, D
Danish: Ratiopharm GmbH, Graf-Ar 3, D
English: No events related to other cerebrovascular disorders were reported in children from clinical trials.
Danish: I de kliniske undersøgelser med børn, blev der ikke indberettet hændels andre cerebrovaskulære sygdomme.
English: 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).
Danish: Methylphenidat har en veldokumenteret virkning på blodtryk og hjertefrekvens (øget puls, øget produktinformationen).
English: Methylphenidate is not licensed for use in adults with ADHD.
Danish: Methylphenidat er ikke godkendt til brug hos voksne med ADHD.
English: 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.
Danish: 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.
English: Not known: cerebrovascular disorders* (including vasculitis, cerebral haemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), grand mal convulsions*, migraine
Danish: Cerebrovaskul ære sygdomme* (herunder vaskulitis, cerebral hæmorrhage og cerebrovaskul ære hændelser, cerebral arteritis, cerebral okklusion), grand mal kramper*, migræne
English: B-2340 Beerse
Danish: eg 30 B-2340 Beerse
English: It is recommended that methylphenidate is de-challenged at least once yearly to assess the child's condition (preferable during times of school holidays).
Danish: Det anbefales, at methylphenidat afbrydes mindst én gang årligt for at vurdere barnets tilstand (hels Forbedringer kan vare ved, når lægem
English: 92500 Rueil-Malmaison France
Danish: 92500 Rueil-Malmaison Frankrig ed modificeret
English: EL - Greece UCB A.E.
Danish: UCB A.E.
English: • mania
Danish: • maniske episoder
English: The regulatory status of the different Methylphenidate containing medicinal products is heterogeneous across EU Member States (MS).
Danish: Registreringsstatussen for de forskellige lægemidler, der indeholder methylphenidat, er den samme i lighed og
English: 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.
Danish: For nogle børn kan behandling med mmen med andre former for ikke-medicinsk behandling, reducere symptomerne på i ungdommen og iale problemer,
English: 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.
Danish: 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.
English: Pharma B.V.; Lage Mosten 33 ; 4822 NK BREDA/NL
Danish: ; Lage Mosten 33 ; 4822 NK BREDA/NL
English: 2.2 Cerebrovascular risk There was no evidence reported from pre-clinical studies in relation to this risk.
Danish: I de prækliniske undersøgelser var der ingen indberetninger om denne risiko.
English: Use with alcohol
Danish: Alkohol
English: Janssen-Cilag s.r.o., Karla Engliše 3201/6, 150 00 Praha 5 - Smíchov, Czech Republic
Danish: Janssen-Cilag s.r.o., Karla 3201/6, 150 00 Praha 5 - S
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Uncommon: hepatic enzyme elevations Very rare: abnormal liver function, including hepatic coma
Danish: Ikke almindelig: forhøjet leverenzymtal Meget sjælden: unormal leverfunktion, inklusive leverkoma
English: If you or your child is taking other medicines, methylphenidate may affect how well other medicines work or may cause side effects.
Danish: vis du eller dit barn tager anden medicin, kan m edicins virkning eller kan give bivirkninger.
English: 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.
Danish: om den samlede anvendte mængde, patientalder, køn, indikationsdosis, varighed af b behandlingskontinuitet, komorbiditete
English: • Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
Danish: • Blodtryk og puls skal kontrolleres og anføres på en percentil kurve ved hver dosisjustereing og efterfølgende minimum hver 6. måned;
English: Monitoring should be at every adjustment of dose and then at least every 6 months or every visit.
Danish: Monitorering bør forekomme ved hver dosisjustering og efterfølgende minimum hver 6. måned eller ved hver konsultation.
English: 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.
Danish: Methylphenidat kan sænke ed tidligere anormale r uden anfald og i sjældne tilfælde uden anfald og anormale EEG-værdier i anamnesen.
English: Uncommon: myalgia, muscle twitching Very rare: muscle cramps
Danish: Ikke almindelig: muskelsmerter, muskeltrækninger Meget sjælden: muskelkramper
English: Use with halogenated anaesthetics
Danish: Halogenerende anæstetika
English: 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
Danish: Almindelig: ændringer i blodtryk og hjerterytme (normalt en stigning)*, vægttab* Ikke almindelig: hjertemislyd*, øget leverenzymtal at antal blodplader,
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Janssen-Cilag Farmacêutica, Lda.Estrada Consiglieri Pedroso, 69 AQueluz de Baixo - 2734-503 Barcarena
Danish: Janssen-Cilag Farmacêutica, Ld Estrada Consiglieri Pedroso Queluz de Baixo - 2734-503
English: - 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
Danish: - har meget højt blodtryk eller karforsnævringer, som muligvis giver smerter i arme og ben ler vaskulære rebral vaskulitis.
English: 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,
Danish: 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.
English: The emergence or worsening of aggression or hostility can be caused by treatment with stimulants.
Danish: 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.
English: 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.
Danish: Langvarig brug (over 12 måneder) til børn og unge Sikkerheden og virkningen ved langvarig brug af methylphenidat er ikke blevet evalu kontrollerede studier.
English: Alfred Tiefenbacher (GmbH & Co. KG); Van-der-Smisse- Strasse 1; 22767 HAMBURG/ Germany
Danish: Alfred Tiefenbacher (Gmb KG); Van-der-Smisse- St 22767 HAMBURG/ Tyskla
English: 10 mg - tablet 20, 30, 40 mg - modifiedrelease capsule, hard
Danish: 10 mg - Tabletter 20, 30, 40 mg - Kapsler med modificeret udløsning, hårde
English: 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.
Danish: 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
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Danish: Der skal sørges for intensiv pleje for at opretholde tilstrækkelig cirkulation og respiration.
English: If manic or psychotic symptoms occur, consideration should be given to a possible causal role for methylphenidate, and discontinuation of treatment may be appropriate.
Danish: Hvis der forek maniske symptomer, bør en mulig årsagssammenhæng med methylphenidat overve af behandlingen kan være relevant.
English: Janssen Cilag N.V./S.A Roderveldlaan 1, B- 2600 Berchem
Danish: Janssen Cilag N.V./S.A Roderv 1, B- 2600 Berchem eldlaan r
English: Learning may or may not be impaired.
Danish: Indlæringsevnen kan muligvis være eller flere symptomer.
English: • 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).
Danish: • Forudeksisterende kardiovaskulære lidels okklusiv sygdom, angina pectoris, hæmodynamisk signifikant medfødt hjerte kardiomyopatier, myokardie (sygdomme som skyldes dysfunktion af ionkanaler).
English: MT - Malta UCB Pharma Limited, 208, Bath Road, Slough, Berkshire SL1 3WE United Kingdom
Danish: MT - Malta UCB Pharma Limited, 208, Bath Road, Slough, Berkshire SL1 3WE Det Forenede Kongerige
English: Caution is advised in patients being treated with methylphenidate with any other drug that can also elevate blood pressure (see also sections on cardiovascular and cerebrovascular conditions in Section 4.4 Warnings and Precautions for use)
Danish: Der skal udvises forsigtighed hos patienter, som bliver behandlet med methy lphenidat og andre lægemidler, der også kan øge blodtrykket (se også afsnit om cerebrovaskulære lide lser i pkt.
English: Slovak republic
Danish: Den Tjekkiske Republik
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing methylphenidate initiated by the European Commission.
Danish: se, der havde fundet sted i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende methylphenidat, og f produkter, der lphenidat til n fra 6 år og til unge i EU.
English: Suicidal tendency
Danish: Selvmord
English: AT - Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
Danish: AT - Østrig Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
English: DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
Danish: and g Tabletten d UCB G Alfred-Nobel-Str. 10 D-40789 Monheim Tyskl
English: In addition the results of the ongoing studies focusing on this issue, once available, will be submitted for assessment as requested by the CHMP (see Annex IV).
Danish: Når resultaterne af de igangværende undersøgelser med fremsendt til vurdering efter anmodning af CHMP (se ændelser fra kliniske undersøgelser fokus på dette emne foreligger, vil de blive bilag IV).