FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: • about any mental health/psychiatric/behavioural problems you or your child or other family members have or have had in the past.
Danish: • event andre familiemedlemmer har eller har haft.
English: AT - Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75
Danish: Janssen-Cilag Pharma GmbH Pfarrgasse 75
English: 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
Danish: Patienter med sjælden arvelig fructoseintolerans, glucosegalactosemalabsorption eller sucrose-isomaltasemangel bør ikke tage dette lægemiddel.
English: Methylphenidate has been available in Europe for decades for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 years and older.
Danish: Methylphenidat har været i handelen i Europa i årtier til behandling af ADHD (attention deficit stof, der tilhører tering.
English: NOVARTIS FARMA S.P.A. Largo Umberto Boccioni 1 21040 VARESE
Danish: NOVARTIS FARMA Largo Umberto Bocc
English: Peripheral coldness and Raynaud's phenomenon are also listed as possible reactions in section 4.8 of some of the SPCs for methylphenidate.
Danish: Kuldefornemmelse og Raynauds fænomen er også angivet som mulige reaktioner under pkt.
English: Long-term treatment
Danish: Langtidsbehandling:
English: Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Danish: Patienter bør nøje monitoreres for risiko for brug til fornøjelse, forkert brug e methylphenidat.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: Methylphenidat er indiceret som en del af et omfattende program over 6 år, som ikke har haft tilstrækkelig gavn af behandling udelukkende ved støtteforanstaltninger.
English: Use in the elderly
Danish: aldersgruppe er i
English: NO - Norway UCB Nordic A/S Arne Jacobsens Allé 15
Danish: NO - Norge UCB Nordic A/S Arne Jacobsens Allé 15
English: 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.
Danish: 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.
English: 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)
Danish: 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.
English: 2.7 Off-label use/misuse/diversion
Danish: Misbrug, forkert brug og diversion
English: 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.
Danish: 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,
English: 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.
Danish: 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.
English: Exacerbation of pre-existing Psychotic or manic symptoms In psychotic patients, administration of methylphenidate may exacerbate symptoms of behavioural disturbance and thought disorder.
Danish: Administration af methylphenidat til psykoti ske patienter kan forværre symptomer på adfærdsændringerne og tankeforstyrrelse.
English: AT - Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
Danish: AT - Østrig Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert ES-08755 Castellbisbal (Barcelona)
English: This medicine is intended solely for you or for your child.
Danish: tilstande eller symptomer gælder for dig eller dit barn.
English: LABORATORIOS RUBIÓ S A, C/INDUSTRIAL 29, POLIGONO INDUSTRIAL, COMTE DE SERT, CASTELLBISBAL, BARCELONA E08755, SPAIN
Danish: LABORATORIOS RUBIÓ S A, C/INDUSTRIAL 29, POLIGONO INDUSTRIAL, COMTE DE SERT, CASTELLBISBAL, BARCELONA E08755, SPANIEN
English: The use of methylphenidate is contraindicated in certain pre-existing cardiovascular disorders unless specialist paediatric cardiac advice has been obtained (see Section 4.3 ‘Contraindications').
Danish: af methylphenidat er kontraindiceret ved visse forudeksisterende kardiovaskulære ædiatriske hjertesygdomme (se re alvorlige specialist.
English: Psychiatric disorders
Danish: Psykiatriske sygdomme
English: You or your child must not drink alcohol while taking this medicine as alcohol may make this medicine's side effects worse.
Danish: Brug af methylphenidat sammen med alkohol Du eller dit barn må ikke drikke alkohol samtidig med brugen af de forværre medicinens bivirkninger.
English: Tell the doctor if there is no improvement in your childs condition after 1 month of treatment with methylphenidate.
Danish: Fortæl det til læ tte, at der skal gen, hvis der ikke er nogen bedring i dit barns åneds behandling med methylphenidat.
English: The MAHs will harmonise the PSUR reporting schedule for methylphenidate-containing products and submit once yearly PSURs for their respective products for the next 3 years, after which the reporting frequency will be reviewed.
Danish: Indehaverne af markedsføringstilladelserne vil udarbejde fuldt harmoniserede e vil harmonisere PSUR-rapporteringsplanen for produkter, ethylphenidat, og én gang årligt indsende PSUR for deres respektive produkter i de skal gennnemgås igen.
English: Prior to initiating treatment with methylphenidate, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Danish: Før behandlingen med methylphenidat initieres, skal patienter med komorbide depressive symptomer gennemgå adækvat screening, for at bestemme om de er i bipolar sygdom.
English: LT - Lithuania UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Lithuania.
Danish: LT - Litauen UAB „Johnson & Johnson“, Geležinio Vilko g. 18A, LT-08104 Vilnius, Litauen.
English: Laboratorios Rubió, S.A. - Calle Industria, 29 - Poligono Industrial Comte de Sert - E-08755 Castellbisbal - Barcelona - Spain
Danish: Laboratorios Rubió, S.A. - Calle Industria, 29 - Poligono Industrial Comte de Sert - E-08755 Castellbisbal - Barcelona - Spanien
English: If the signs and symptoms are not too severe and the patient is conscious, gastric contents may be evacuated by induction of vomiting or gastric lavage.
Danish: Hvis tegn og symptomer ikke er for alvor ved bevidsthed, kan maven tøm
English: DK-2300 Kobenhavn S Denmark
Danish: DK-2300 Kø Danmark
English: Reproductive system and breast disorders Rare: Gynaecomastia
Danish: Det reproduktive system og mammae Sjælden: Brystforstørrelse
English: • development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then least every 6 months and at every visit.
Danish: • Udvikling af nye eller forværring af forudeksisterende psykiatriske sygdom ved hver dosisjustering og efterfølgende minimum hver 6. måned s
English: If the analysis on the basis of the currently available data is deemed feasible, the MAHs will make the resources available to support the analysis and update the RMP to reflect its findings.
Danish: Hvis analysen på baggrund af de aktuelt tilgængelige data vurderes mulig, vil indehaverne af ttelse af analysen og et vurdering af points for følgende psykotiske lidelser)
English: SE - Sweden UCB Nordic A/S Arne Jacobsens Allé 15
Danish: SE - Sverige UCB Nordic A/S Arne Jacobsens Allé 15
English: The MAHs submitted data supporting the position that there is no preclinical or clinical evidence for a significant carcinogenic risk associated with methylphenidate.
Danish: Indehaverne af markedsføringstilladelserne indsen understøttede det synspunkt, at der ikke er nogen præklinisk eller klinisk evidens cancinogen risiko i forbindelse med methylphenidat.
English: Uncommon: hypersensitivity reactions such as angioneurotic oedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritis, rashes and eruptions
Danish: Ikke almindelig: overfølsomhedsreaktioner som angioneurotisk ødem, anafylaktiske reaktioner, hævelse i det ydre øre, blæredannelse, hudafskalning, nældefeber, kløe, eksem og udslæt.
English: Patient age, the presence of risk factors for substance use disorder (such as co-morbid oppositionaldefiant or conduct disorder and bipolar disorder), previous or current substance abuse should all be taken into account when deciding on a course of treatment for ADHD.
Danish: Patientens alder, tilstedeværelse af risikofaktorer for narkotika/lægemiddel misbrug (såsom samtidig ons- eller trodsforstyrrelser og bipolar sygdom), tidligere eller nuværende stofmisbrug, bør ed hos emotionelt ngighed i anamnesen, da disse patienter ylphenidat eller andre stimulerende midler kan være uegnede til behandling af patienter, som er i
English: DE - Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstr.8
Danish: skland et tten d Janssen-Cilag Gm 41457 Neuss or Janssen Cilag Raiffeisenstr.8
English: ISERLOHN GERMANY
Danish: ISERLOHN TYSKLAND
English: Furthermore, 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: Endelig vil de relevante afsnit i produktinformationen efter CHMP's anmodning blive ændret med ang til vurderingen og ersøgelser med fokus på dette emne foreligger, vil de blive fremsendt til vurdering efter anmodning af CHMP (se bilag IV).
English: 5, 10, 20 mg - tablet 10, 20, 30, 40 - prolongedrelease capsule, hard
Danish: 10, 20, 30, 40 - Depotkapsler, hårde
English: Respiratory, thoracic and mediastinal disorders Common: cough, pharyngolaryngeal pain Uncommon: dyspnoea
Danish: Luftveje, thorax og mediastinum Almindelig: hoste, smerte i svælg og strube Ikke almindelig: dyspnø
English: Checks that your doctor will make before treatment with methylphenidate begins:
Danish: Din læge kontrollerer nedenstående, før behandlingen med methylphenida
English: CY - Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30
Danish: CY - Cypern Janssen-Cilag Internation Turnhoutsew al N.V
English: Longstanding abuse of methylphenidate can lead to marked tolerance, psychological dependence, abnormal behaviour, psychotic episodes.
Danish: Langvarigt misbrug af methylphenidat kan f unormal adfærd, psykotiske episoder.
English: These symptoms could include severe headache, numbness, weakness, paralysis, and impairment of coordination, vision, speech, language or memory..
Danish: Cerebral vaskulitis synes at være en meget sjælden særegen reaktion på eksponering for omfatte alvorlig hovedpine, følelsesløshed, kraftesløshed, lammelser og svækkelse af koordination, syn, tale, sprog eller hukommelse.
English: Because of possible hypertensive crisis, methylphenidate is contraindicated in patients being treated (currently or within the preceding 2 weeks) with non-selective, irreversible MAO-inhibitors (see section 4.3 Contraindications).
Danish: På gr behandling (løbende eller inden for de sidste 2 uger) med ikke-selektive, irreversib (se pkt.
English: UCB PHARMA LIMITED, BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE UNITED KINGDOM
Danish: UCB PHARMA LIMITED, BATH ROAD, SLOUGH, BERKSHIRE SL1 3WE DET FORENEDE KONGERIGE
English: Most frequently reported psychiatric adverse events of interest from spontaneous reports were abnormal behaviour, abnormal thinking, anger, hostility, aggression, agitation, tic, irritability, anxiety, crying, depression, somnolence, aggravated ADHD, psychomotor hyperactivity, emotional disorder, anger, nervousness, psychotic disorder, mood swings, morbid thoughts, obsessive-compulsive disorder, personality change/disorder, restlessness, confusional state, hallucinations, lethargy, paranoia and suicidality.
Danish: De hyppigst indberettede psykiatriske bivirkninger af interesse unormal adfærd, unormal tankegang, vrede, fjendtlighed, aggression, agitation, tics gråd, depression, somnolens, forværring af ADHD, psykomotorisk hyp vrede, nervøsitet, psykotisk lidelse, stemningssvingninger, sygelig tankegang tilstand suicidalitet.
English: DE - Germany 1 A Pharma GmbH Keltenring 1 + 3
Danish: DE - Tysklan 1 A Pharma GmbH rhaching
English: The recently published retrospective case control review of prescription records for more than 35,000 patients did not indicate either a moderate or a strong association between methylphenidate use and cancer risk in children for any of 18 defined cancer sites.
Danish: data for mere end indikerede hverken en moderat eller en stærk forbindelse mellem brug af ethy n af de 18 angivne cancerforsøgscentre.
English: Benefit/risk
Danish: Benefit/risk-forholdet Efter at have taget disse elementer i betragtni
English: JANSSEN-CILAG LIMITED, SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP14 4HJ, UNITED KINGDOM
Danish: JANSSEN-CILAG LIMITED, SAUNDERTON, HIGH WYC BUCKINGHAMSHIRE, HP1
English: Excipients: galactose/sucrose intolerance
Danish: Hjælpestoffer: galactose-/saccharoseintolerans {Udfyldes om nødvendigt nationalt}
English: Although some serious heart problems alone may carry an increased risk of sudden death, stimulant products are not recommended in children or adolescents with known cardiac structural abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medicine.
Danish: Selv om visse misdannelser i hjertet i sig selv kan in for pludselig død, anbefales stimulerende stoffer ikke til børn eller unge med kendte strukturelle hjerteproblemer, som k stimulerende lægemiddel.
English: ES - Spain Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
Danish: ES - Spanien Medice Arznemitel Putter GMBH Kuhloweg, 37 D 58638
English: Methylphenidate can cause dizziness, drowsiness and visual disturbances including difficulties with accommodation, diplopia and blurred vision.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene m Methylphenidat kan forårsage svimmelhed, døsighed og synsforstyrrelser, inklusiv akkommodationsbesvær, diplopi og sløret syn.
English: In the case of emergent psychiatric symptoms or exacerbation of preexisting psychiatric disorders, methylphenidate should not be given unless the benefits outweigh the risks to the patient.
Danish: Forværring af forudeksisterende psykotiske eller maniske symptomer mindre de gavnlige virkninger opvejer risici for patienten.
English: Following the discussions at the CHMP it was agreed that long-term use data is still needed on a potential effect of methylphenidate on cardiovascular and cerebrovascular events.
Danish: Efter drøftelserne i CHMP blev man enige om, at der stadig savnes data fra langtidsbrug om en delser.
English: - have a diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder - has heart problems such as a history of a heart attack, irregular heartbeat, pain and discomfort in the chest, heart failure, heart disease or significant problems with the structure or function of the heart that were present at birth.
Danish: I'er) mod depression eller har taget rrelser ighedsforstyrrelse igere har lidt af svær og tilbagevendende (type I) bipolar e, smerter og ubehag i eller væsentlige problemer med hjertets struktur eller funktion,
English: IE - Ireland Janssen-Cilag Ltd, Saunderton, High Wycombe HP14 4HJ,
Danish: IE - Irland Janssen-Cilag Ltd, Saunderton, High Buckinghamshire, England.
English: AT - Austria Novartis Pharma GmbH Brunner Straße 59
Danish: Novartis Pharma GmbH Straße 59
English: Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including methylphenidate.
Danish: Alkohol kan forværre CNS-bivirkningerne af psykofarmaka, herunder methyl derfor, at patienter undgår alkohol under behandlingen.
English: DE - Germany Novartis Pharma GmbH D-90327 Nuernberg
Danish: GmbH rg d Novartis Pharma D-90327 Nuernbe
English: The EC considered that some safety concerns, including cardiovascular and cerebrovascular disorders, potentially associated with methylphenidate treatment should be evaluated.
Danish: Europaar af den opfattelse, at visse potentielle sikkerhedsproblemer, heriblandt hjerte-kard methylphenidat skulle
English: Marketing Authorisation Holder
Danish: markedsføringstilladelse
English: - have glaucoma (increased pressure in the eye) - have phaeochromocytoma (a tumour of the adrenal gland) - are taking medicines known as monoamine oxidase inhibitors (MAOIs) for depression, or have taken MAOIs in the last 14 days - have thyroid problems - suffer from anorexia nervosa or anorexic disorders - suffer from depression, mood disorders, mania, or have suicidal thoughts - suffer from psychotic symptoms or schizophrenia or psychopathic/borderline personality disorder.
Danish: at må ikke g ikke methylphenidat, hvis du eller dit barn er overfølsom (allergisk) methylphenidat har forhøjet tryk i øjet (grøn stær) har en tumor i binyren tager lægemidler kaldet monoaminoxidasehæmmere (MAO MAOI'er inden for de seneste 14 dage har problemer med skjoldbruskkirtlen lider af anoreksi (nervøs spisevægring) eller anoreksilignende forsty lider af depression, stemningsforstyrrelser, mani eller har selvmordstanker har psykotiske symptomer eller skizofreni eller psykopatisk/borderline personl har en diagnose på eller tidl (maniodepressiv) affektiv sindslidelse har hjerteproblemer som tidligere hjerteanfald, uregelmæssig hjerterytm brystet, hjertesvigt, hjertesygdom som har været til stede ved fødslen
English: Rare: angina pectoris
Danish: Angina einf arkt
English: Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.
Danish: medicinske og specialiserede psykologiske,
English: Drug treatment is usually discontinued during or after puberty.
Danish: Behandlingen skal overvåges af en specialist i adfærdsf Lægemiddelbehandling afbrydes som regel under eller efter puberteten.
English: Methylfenidaat HCl 10 mg PCH 10 mg tablets
Danish: Methylfenidaat HCl 10 mg PCH 10 mg
English: QUASYM L.P. 10MG, GELULE A LIBERATION MODIFIEE
Danish: 10MG, GELULE A LIBERATION MODIFIEE
English: UCB Nordic A/S Arne Jacobsens Allé 15 2300 Köbenhavn S Denmark
Danish: UCB Nordic A/S Arne Jacobsens A 2300 Københa Danmark
English: Your child should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Danish: e skal overvåges for risikoen for afhængighed og misbrug af methylphenidat.
English: Novartis Healthcare A/S, c/o Vistor hf., Hörgatún 2, 212 Garðabær, Iceland
Danish: Novartis Healthcare A/S, c/o Vistor hf., Hörgatún 2, 212 Garðabær, Island
English: In addition more data is needed to assess the psychiatric outcome as well as the effect on growth and development of the children.
Danish: potentiel virkning af methylphenidat på kardiovaskulære og cerebrovaskulære hæn der behov for flere data for at vurdere de psykiatriske behandlingsresultater samt in vækst og udvikling hos børn.
English: <If you have any further questions on the use of this product, ask your <doctor> <or> <pharmacist>.>
Danish: <Spørg lægen eller på apoteket, hvis der er noget, <De><du> er
English: Uncommon: constipation
Danish: Almindelig: ledsmerter
English: ES - Spain Laboratorios RUBIO, SA Industria 29- Polígono industrial Comte de Sert
Danish: Laboratorios RUBIO, SA Industria 29- Polígono in Comte de Sert
English: MEDICE ARZNEIMITTEL PUTTER GMBH & CO KG; KUHLOWEG 37; ISERLOHN 58638; GERMANY
Danish: MEDICE ARZNEIMITTEL PUTTER GMBH & CO KG; KUHLOWEG 37; ISERLOHN 58638; TYSKLAND
English: The analysis of the data provided by MAHs showed a highly variable effect of methylphenidate on blood pressure and heart rate.
Danish: Et af de vigtigste formål med de methylphenidat på blodtryk og hjertefrekvens.
English: NOVARTIS PHARMACEUTICALS UK LIMITED, FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY GU16 7SR, UNITED KINGDOM
Danish: NOVARTIS PHARMACEUTI UK LIMITED, FRIMLEY BU PARK, FRIMLEY, C SURREY GU16 7SR,
English: So, there is the need for this information to be clear to the prescribers and the public by strengthening the wording of the Product Information of the products.
Danish: Det er således nødvendigt ordinerende læger og for offentligheden ved at skærpe ordlyden i produkternes prod Desuden er der igangværende kliniske undersøgelser af disse emner, og de e
English: Diagnosis cannot be made solely on the presence of one or more symptom.
Danish: ICD-10 og skal være baseret på en komplet anamnese og vurdering af patien En diagnose kan ikke udelukkende baseres på tilstedeværelse af et eller flere symptom
English: Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms.
Danish: Hvis midler baseres på ående vurdering af sværhedsgraden af barnets symptomer.
English: Vascular disorders*
Danish: Vaskulære mme*
English: Castellbisbal 08755
Danish: 08755-Castellbis SPANIEN
English: CONCERTA 18 mg retard tabletta
Danish: Concerta 18 mg Retardtabletten