natgillin/translations-raw huggingface dataset:
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
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.
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)
Den Tjekkiske Republik
Slovak republic
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.
- 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.
Selvmord
Suicidal tendency
AT - Østrig Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
AT - Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37
and g Tabletten d UCB G Alfred-Nobel-Str. 10 D-40789 Monheim Tyskl
DE - Germany UCB GmbH Alfred-Nobel-Str. 10 D-40789 Monheim
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).
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).
Indehaverne af markedsføringstilladelsern der indeholder m kommende tre år, hvorefter rapporteringsfrekvensen PSUR-indsendelse vil gøre det lettere for de kompetente nationale myndigheder vurdering og give et harmoniseret svar i forbindelse med opdateringer af produktresumé/indlægsseddel og risikostyringsplan.
The synchronisation of the PSUR submission will facilitate a common assessment and harmonised response by the National Competent Authorities on updates of the SPC / PL and RMP.
• event andre familiemedlemmer har eller har haft.
• about any mental health/psychiatric/behavioural problems you or your child or other family members have or have had in the past.
Patienter med sjælden arvelig fructoseintolerans, glucosegalactosemalabsorption eller sucrose-isomaltasemangel bør ikke tage dette lægemiddel.
This medicinal product contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine
Methylphenidat har været i handelen i Europa i årtier til behandling af ADHD (attention deficit stof, der tilhører tering.
Methylphenidate has been available in Europe for decades for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 years and older.
NOVARTIS FARMA Largo Umberto Bocc
NOVARTIS FARMA S.P.A. Largo Umberto Boccioni 1 21040 VARESE
Kuldefornemmelse og Raynauds fænomen er også angivet som mulige reaktioner under pkt.
Peripheral coldness and Raynaud's phenomenon are also listed as possible reactions in section 4.8 of some of the SPCs for methylphenidate.
Langtidsbehandling:
Long-term treatment
Patienter bør nøje monitoreres for risiko for brug til fornøjelse, forkert brug e methylphenidat.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
I indehaveren af markedsføringstilladelsens gennemgang af spontant indberettede d markedsføringen blev det konkluderet, at cerebrovaskulære hændelser fra spontane indberetninger overvejende bestod af indberettede udtryk: hjerneblødning, slagtilfælde, blodprop og cerebral iskæmi rrende tilfælde uden ndelse med blodprop kæmi.
The MAH review of post-marketing spontaneous data found that cerebrovascular events from spontaneous reports consisted mainly of the reported terms: cerebrovascular accident, stroke, cerebral infarction and cerebral ischemia as well as a few reports of other events.
Sikkerheden ved langvarig behandling med methylphenidat er ikke fuldstændi leukopeni, trombocytopeni, anæmi eller andre forandringer, inklusive tegn på alvor leversygdomme, bør seponering af behandlingen overvejes.
In the event of Leukopenia, thrombocytopenia, anaemia or other alterations, including those indicative of serious renal or hepatic disorders, discontinuation of treatment should be considered.
Methylphenidat er indiceret som en del af et omfattende program over 6 år, som ikke har haft tilstrækkelig gavn af behandling udelukkende ved støtteforanstaltninger.
Methylphenidate is indicated as a part of a comprehensive treatment programme for ADHD in children over 6 years of age where remedial measures alone prove insufficient.
aldersgruppe er i
Use in the elderly
NO - Norge UCB Nordic A/S Arne Jacobsens Allé 15
NO - Norway UCB Nordic A/S Arne Jacobsens Allé 15
lvmordstendens stimulerende midler Patienter behandlet med methylphenidat bør monitoreres nøje forværring af aggressiv adfærd eller fjendtlighed ved behandlingsstar efterfølgende minimum hver 6. måned samt ved hver konsultation.
Patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit.
Screen entere orbide psykiatriske sygdomme eller symptomer, familieanamnese med pludselig hjertedød/uforklarlig død samt omhyggelig angivelse af højde og vægt på en vækstkurve (se pkt.
A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart (see sections 4.3 and 4.4)
Misbrug, forkert brug og diversion
2.7 Off-label use/misuse/diversion
Konklusionerne af denne vurdering resulterede i en forslag fra CHMP om at skærpe forskellige produktinformationer for produkterne, så de omfattede overvåg opdatering af de afsnit i produktresuméet, der omhandler kontraindikationer og advarsler,
The conclusions of this assessment led to a CHMP proposal on strengthening and harmonising the respective Product Information of the products with the inclusion of pre- and post-treatment monitoring, updating the sections of the SPC related to the contraindications and warnings, harmonising the information on adverse reactions, checking of the posology and use, updating the information on use in pregnancy and lactation.
Et omfattende behandlingsprogram inkluderer sædvanligvis psykologiske, pædagogiske og sociale adfærdssyndromer er kendetegnet ved symptomer, som kan omfatte en sygehist koncentrationsbesvær, distraktion, følelsesmæssig ustabilitet, impulsivitet, modera hyperaktivitet, mindre neurologiske svækket.
A comprehensive treatment programme typically includes psychological, educational and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG.
Administration af methylphenidat til psykoti ske patienter kan forværre symptomer på adfærdsændringerne og tankeforstyrrelse.
Exacerbation of pre-existing Psychotic or manic symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.
AT - Østrig Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
AT - Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
tilstande eller symptomer gælder for dig eller dit barn.
This medicine is intended solely for you or for your child.