FrancophonIA/ELRC3.0 huggingface dataset:
English: • pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Danish: • Forudeksisterende cerebrovaskulære sygdomme, cerebral aneurisme, vaskulære abnormaliteter ighedsregler vedrørende brugen tningen om at d og varighed af hypertensive kriser (se pkt.
English: Take special care with methylphenidate and tell a doctor if you or your child - Has been told to take these tablets for longer than 12 months (see section 3 below, on long-term use) - Is entering puberty (teenage years) - Is about to stop taking methylphenidate as your doctor may want to monitor your child for depression - has a heart disease or other serious heart problem - has had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms brain scans) - has high blood pressure.
Danish: - er på vej ind i p - skal til at stoppe med at tage methylphenidat, da lægen i så fald måske vil eventuel depression - har en hjertesygdom eller andre alvorlige hjert - har haft krampeanfald (kramper, epile hjernescanninger) - har højt blodtryk.
English: Medice Arzneimittel Pűtter GmbH & Co Kuhloweg 37
Danish: Medice Arzneimittel Pütter Gm Kuhloweg 37
English: 5 mg Tablets
Danish: 5MG TABLETTER
English: In addition the results of the ongoing study on suicidality will be submitted once available and the MAHs undertook the commitment to investigate psychiatric outcomes in a future long-term study.
Danish: Gennemgangen af de prækliniske data i svarene viser, at methylphenidat forårsager foreligger, vil disse desuden blive indsendt, og indehaverne af markedsføringstilladelserne vil påtage kiatriske behandlingsresultater i fremtidige langtidsundersøgelser.
English: RILATINE MODIFIED RELEASE 20 MG
Danish: RILATINE MODIFIERELE 20 mg
English: The MAHs committed to it.
Danish: Produktr overensstemmelse med dette.
English: Equasym tabletter 20 mg tablet
Danish: Equasym tabletter 20 mg
English: Methylphenidate should not be given to children under 6 years of age or the elderly as the safety and benefits of use in these age groups have not been established.
Danish: Methylphenid gives til børn under 6 år eller til ældre, da sikkerhed og fordele ved brugen idat, og fortæl det til en læge, hvis du eller dit ret i at tage disse tabletter længere end 12 måneder (se afsnit 3 nedenfor om eenageårene)
English: It is widely accepted (from review of the literature) that long-term safety and effectiveness of methylphenidate has not been conclusively proven in suitably designed and conducted studies.
Danish: Det er alment accepteret (fra gennemgang af litteraturen), at den langsigtede sikke behandling m rhed og virkning af ed methylphenidat ikke er blevet definitivt påvist i undersøgelser med passende design erne af markedsføringstilladelserne påtog sig at undersøge muligheden for at gennemføre en langtidsundersøgelse af børnenes udvikling og at udarbejde en undersøgelsesprotokol efter CHMP's rug og diversion blev t ud fra de indsendte data.
English: Ritalin tablet
Danish: Ritalin stor
English: Elderly
Danish: drhein
English: MT - Malta Janssen-Cilag International N.V. Turnhoutseweg 30
Danish: MT - Malta ilag International N.V.
English: (10 mg - tablet) mg, 30 mg, 40 mg - modifiedrelease capsule, hard)
Danish: Ritalin tabletter) g, 40 mg - Kapsler med modifice hårde)
English: 10 mg Tablets
Danish: 10 mg Tabletter
English: MEDIKINET 40 mg cápsulas liberación prolongada
Danish: ET 40 mg cápsulas liberación prolongada
English: tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis and dryness of mucous membranes.
Danish: Abdominals rter, rré, kvalme, vegener astning.
English: Medikinet 40 mg - retardierte Hartkapseln
Danish: edikinet 40 mg - retardierte Hartkapseln
English: ITItaly
Danish: DEPOTKA
English: Equasym XL 30mg Modified-release capsules, hard
Danish: Equasym XL 30mg Modified-release sules, hard
English: Modified release capsule, hard.
Danish: Kapsler med modificeret udløsning, hårde
English: Efficacy of peritoneal dialysis or extracorporeal haemodialysis for overdose of methylphenidate has not been established.
Danish: se eller ekstrakorporal hæmodialyse ved overdosering af methylphenidat er
English: Common: arrhythmia, tachycardia palpitations
Danish: Brystgener, hyperpyreksi
English: Psychiatric effects
Danish: BIVIRKNINGER
English: Drug screening
Danish: Lægemiddelscreening atorietest for
English: Where analyses of medical history or concurrent medications were provided, these did not provide conclusive evidence of predictive risk factors for cardiovascular effects of methylphenidate.
Danish: I de tilfælde, hvor analyser af a medicinering blev forelagt, gav disse ingen afgøre namnese eller samtidig nde beviser for prædiktive risikofaktorer med blodtryk og takykardi er velkendte bivirkninger ved methylphenidat, som fremgår af ersible efter enterede data om omfanget af og hjertefrekvens samt om langtidsvirkningerne og de kliniske at indsende data fra spontane indberetninger.
English: Eye disorders
Danish: Depotkapsler
English: Dose titration
Danish: Depot tter
English: Treatment must be under the supervision of a specialist in childhood behavioural disorders.
Danish: Behandlingen skal foretages under tilsyn af en læge med
English: 20MG TABLET
Danish: 20MG TABLETTER
English: UCB Nordic A/S, c/o Vistor hf., Hörgatúni 2, 212 Garðabær, Iceland
Danish: UCB Nordic A/S, c/o Visto r , Hörgatúni 2, 212 Garðabær, Is
English: {For inclusion in the PL of non-modified release formulations of methylphenidate:} “Taking methylphenidate with food and drink Taking methylphenidate with food may help relieve stomach pains, feeling sick or vomitting.”
Danish: ylphenidat sammen med mad og drikke rter, kvalme og opkastninger, hvis methylphenidat tages nne medicin, da alkohol kan idler kan indeholde alkohol.
English: 18mg, 27mg 36mg, 54mg
Danish: 18mg, 36mg,
English: In addition 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: Derfor tte rådgivning om ehandling med disse en konsekvent og rne (Periodic Safety Reports) og risikostyringsplanerne.
English: • palpitations, unexplained fainting chest pain, shortness of breath ( these can sometimes be signs of cardiac disease)
Danish: ser, herunder syns-, føle- eller hørehallucinationer eller anken, uforklarlige besvimelsesanfald, brystsmerter, kortåndethed (det kan somme tider gdom)
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Stigning i leverenzymer
English: The data submitted on the risk of cardiovascular disorders covered a range of reporting periods.
Danish: 2.1.b Data fra spontane indberetninger I løbet af denne procedure er indehaverne af markedsføringstilladelserne blevet bedt om omfattede en række indberetningsperioder.
English: Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy, repetitive behaviours, over-focussing, Not known: delusions*, thought disturbances*, confusional state, dependence.
Danish: temningsleje, skiftende stemningsleje, rastløshed, let til tårer, tics*, forværring af eksisterende tics eller Tourettes syndrom*, overdreven vagtsomhed, søvnforstyrrelser Sjælden: maniske episoder*, forvirring, libido-forstyrrelse Meget sjælden: selvmordsforsøg (inklusive gennemført selvmord)*, forbigående nedtrykt stemningsleje*, unormal tankegang, apati, gentagen adfærd, overfokusering, Ikke kendt: vrangforestillinger*, tankeforstyrrelser*, forvirret sindstilstand
English: In addition, clinical studies investigating the issues are currently ongoing and the final reports will be submitted to the regulatory authorities.
Danish: ndelige rapporter vil blive sendt til registreringsmyndighederne.
English: ADHD can also have a severe effect on a child's education.
Danish: ommen ADHD lene er speciale i adfærdssygdomme hos børn.
English: When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from methylphenidate.
Danish: atienter med behandling med henidat undersøges for methylphenidat.
English: Taking methylphenidate with alcohol
Danish: Methylphenidat kan nedsæ
English: - Non-selective, irreversible, monoamine oxidase (MAO) inhibitors (used to treat depression) - Vasopressor agents (drugs which may increase blood pressure) - Medicines used to reduce the blood pressure, for example clonidine, guanethidine,
Danish: Hvis du eller dit bar lgende lægemidler, skal du spørge lægen, før du tager metylphenida ikke-selektive, irreversible monoaminoxidase (MAO)-hæm behandling af depression) - karsammentræ medicin, som anvendes til at nedsætte blodtrykket, for eksem guanethidin, verapamil, propranolol et - visse midler mod hoste og forkølelse, som indeholder ingredien påvirke blodtrykket.
English: See section 4.3 for conditions in which methylphenidate treatment in contraindicated.
Danish: for tilstande hvor methylphenidat er kontraindiceret.
English: CONCERTA 18 mg Retardtabletten 18. mg Prolonged-release tablet
Danish: CONCERTA 18 mg Retardtabletten 18. mg d Janssen-Cilag Gm 41457 Neuss or Raiffeisenstr.8
English: Dizziness, drowsiness and visual disturbances may occur when taking methylphenidate.
Danish: ommer psykotiske eller jes, og seponering kan skyldes behandling med methylphenidat i normale doser.
English: Laboratorios Rubio, S.A.; C\Industria, no. 29 Pol. Ind. Comte de Sert; 08755 CASTELLBISBAL, BARCELONA/ SPAIN
Danish: Laboratorios Rubio, S.A.; C\In no. 29 Pol. Ind. Comte de Sert CASTELLBISBAL, BARCE
English: Infections and infestations Common: Nasopharyngitis
Danish: behandlingen og ka Ikke almindelig: forstoppelse
English: Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Danish: Væksten b kon nødvendigt, at afbryde behandlingen midlertidigt hos patienter, som ikke vokser elle som forventet.
English: Methylfenidaat HCl 10 mg tablets
Danish: Methylfenidaat HCl 10 m etten
English: If the ADRs with {invented name} and the methylphenidate formulation frequencies were different, the highest frequency of both databases was used.
Danish: Hvis bivirkningerne med {Produktnavn} og frekvenserne at-formuleringer var forskellige, blev den højeste frekvens i begge databaser lig (≥ 1/100 til < 1/10) ≥ 1/1.000 til <1/100)
English: The pre-clinical data on the risk of cardiovascular disorders submitted suggested that methylphenidate does not have an effect on rapidly activating inward rectifying potassium channels (which play a role in neuronal excitability and heart rate) or on action potential duration.
Danish: tid til den opfattelse, at ve mistanke om en haverne af oduktinformation (PI) for data De indsendte prækliniske data om risikoen for hjerte-kar-sygdomme antydede, at methylphenidat ikke (som spiller en rolle ed.
English: UCB Nordic A/S c/o Vistor hf. Hörgatúni 2, 212 Garðabær, Iceland
Danish: UCB Nordic A/S, c/o Visto Hörgatúni 2, 212 Garðabær, Is nd
English: 10MG TABLET
Danish: 10MG TABLETTER
English: The MAHs will make available the final report of the study, when published, and will update the RMP, and where appropriate the SPC/PL, to reflect the findings.
Danish: Indehaverne af markedsføringstilladelse endelige rapport fra undersøgelsen tilgængelig angsat af at undersøge, om undersøgelsen har adie hver 6. måned e overvåget for at st og udvikling under opvæksten rne vil gøre den , når denne publiceres, og vil opdatere og, hvor det er aktuelt, produktresumé/indlægsseddel, så resultaterne afspejles i disse.
English: 18 mg Prolonged-release tablets
Danish: 18MG DEPOTTABLETTER
English: 5 mg 10 mg 20 mg tablet
Danish: 10 mg 20 mg
English: Withdrawal
Danish: Republi
English: • During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis (see section
Danish: • Under behandling med ikke-selektive, irreversible monoaminoxidasehæm eller inden for de første mere (MAO-hæmmere) 14 dage efter seponering af disse lægemidler, på grund af risiko for sion, nervøs er, alvorlige dsstruktur ikke er tiv) sindslidelse er inklusive alvorlig hypertension, hjertesvigt, arteriel sygdom, infarkt, potentielt livstruende hjertearytmier og kanalopatier
English: Tabletss
Danish: Depottablette
English: MPH Novartis 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung
Danish: MPH Novartis 20 mg H mit veränderter Wirk ffreisetz udløs de
English: Driving or using machines
Danish: VIRKNING OG ANVENDELSE
English: Concerta 27 mg Retardtabletten 27 mg Prolonged-release tablet
Danish: Concerta 27 mg Retardt
English: PACKAGE LEAFLET
Danish: Kapsl odificeret
English: FI - Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638
Danish: Medice Arzneimittel Pütter Gm Co KG Kuhloweg 3 DE-58638 Iserlohn
English: D-82041 Oberhaching
Danish: Keltenring 1 + 3 D-82041 Obe
English: prolonged release capsules oral
Danish: Kapsler med udløsning
English: The Reference Member State was Finland and the Concerned Member State was Germany.
Danish: Referencemedlemsstaten var Finland og den berørte medlemsstat var Tyskland.
English: 21 February 2006 EMEA/CHMP/373108/2005
Danish: 21. februar 2006 EMEA/CHMP/373108/2005
English: These Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater har ikke kunnet nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol CT-Arzneimittel.
Danish: På sit møde i september 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet er gunstigt for Lansoprazol CTArzneimittel.
English: Lansoprazol CT-Arzneimittel (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastrooesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Danish: Lansoprazol CT-Arzneimittel (lansoprazol) er en protonpumpehæmmer, som hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gastrisk ulcus, reflux øsofagitis, gastro-øsofageal reflukssygdom, behandling og profylakse af NSAID-relaterede gastriske og duodenale ulcera, Zollinger-Ellisons syndrom og i kombination med passende antibakterielle behandlingsregimener til udryddelse af Helicobacter pylori og forebyggelse af recidiv af peptiske ulcera hos patienter med H. pylori-relaterede ulcera.
English: A Marketing Authorisation for Lansoprazol CT-Arzneimittel (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Danish: Der er tidligere udstedt en markedsføringstilladelse for Lansoprazol CT-Arzneimittel (15 mg og 30 mg) til ratiopharm GmbH i Finland.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol CT-Arzneimittel 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Lansoprazol CT-Arzneimittel 15 mg og 30 mg Internationalt fællesnavn ( INN): Lansoprazol
English: Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Danish: CHMP godkendte ændringerne af afsnit 4.2 (dosering og indgivelsesmåde) og præciserede den anbefalede dosering for antibiotika i overensstemmelse med ”punkter, der bør overvejes vedrørende ordlyden af Helicobacter pylori-eradikationsbehandlingen i de forskellige afsnit af produktresuméet” og vedtog en positiv udtalelse den 15. september 2005.
English: 0.25 mg Powder for concentrate for solution for infusion
Danish: 0,25 mg pulver til koncentrat til infusionsvæske, opløsning
English: Strength Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration
English: It is used in two groups of patients:
Danish: Det anvendes hos to hovedgrupper af patienter:
English: It is provided in various strengths.
Danish: Det fås i forskellige styrker.
English: The lowest dose that provides adequate control of symptoms should be used.
Danish: Den laveste dosis, som giver tilstrækkelig kontrol med symptomerne, skal anvendes.
English: Aranesp received a marketing authorisation valid throughout the EU on 8 June 2001.
Danish: Aranesp fik en markedsføringstilladelse med gyldighed i hele EU den 8. juni 2001.
English: Further information on Aranesp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aranesp.
Danish: Yderligere information om Aranesp findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/aranesp.
English: Other information about Aranesp
Danish: Andre oplysninger om Aranesp
English: As for all medicines, data on the use of Aranesp are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Aranesp løbende overvåget.
English: • adults who are receiving chemotherapy for non-myeloid cancer (cancer not originating in the bone marrow).
Danish: • voksne, som får kemoterapi for ikke-myeloid kræft (kræft, der ikke har sin oprindelse i knoglemarven).
English: What measures are being taken to ensure the safe and effective use of Aranesp?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aranesp?
English: In two studies involving 669 patients receiving chemotherapy, Aranesp was more effective than placebo (a dummy treatment) and fewer patients needed a blood transfusion.
Danish: I to studier, der omfattede 669 patienter, som fik kemoterapi, var Aranesp mere effektivt end placebo (en uvirksom behandling), og færre patienter havde brug for en blodtransfusion.
English: An overview of Aranesp and why it is authorised in the EU
Danish: En oversigt over Aranesp, og hvorfor det er godkendt i EU
English: For more information about using Aranesp, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Aranesp, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Side effects reported with Aranesp are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Aranesp vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency decided that Aranesp's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Aranesp opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels and at keeping these levels maintained, whether given as an injection into a vein or under the skin.
Danish: Aranesp var lige så effektivt som rekombinant humant erytropoietin til at øge hæmoglobinniveauerne og opretholde disse niveauer, uanset om det blev givet som en indsprøjtning i en vene eller under huden.
English: The dose and frequency of injection depend on why Aranesp is being used, and are adjusted, according to the patient's response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre).
Danish: Indsprøjtningens dosis og hyppighed afhænger af, hvorfor Aranesp anvendes, og skal justeres i henhold til patientens respons for at opnå et hæmoglobinindhold, der ligger inden for det anbefalede interval (mellem 10 og 12 gram pr. deciliter).
English: It must be injected under the skin in patients receiving chemotherapy.
Danish: Det skal gives som indsprøjtning under huden til patienter, som får kemoterapi.
English: Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms.
Danish: Aranesp er et lægemiddel, der anvendes til behandling af anæmi (lavt antal røde blodlegemer), som giver symptomer.
English: Because of the slight changes to the structure, darbepoetin alfa remains in the body for longer than natural erythropoietin.
Danish: På grund af den let ændrede struktur bliver darbepoetin alfa i kroppen i længere tid end naturligt erytropoietin.
English: Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults.
Danish: Aranesp er også blevet undersøgt hos 124 børn med kronisk nyresvigt for at kontrollere, at det absorberes på samme måde som hos voksne.
English: Aranesp contains the active substance darbepoetin alfa.
Danish: Aranesp indeholder det aktive stof darbepoetin alfa.
English: What is Aranesp and what it is used for?
Danish: Hvad er Aranesp, og hvad anvendes det til?
English: The company that markets Aranesp will provide educational packs for patients and healthcare professionals including information on how to self-inject the medicine, a training checklist and a demonstration device.
Danish: Virksomheden, der markedsfører Aranesp, vil udlevere oplysningsmateriale til patienter og sundhedspersoner, herunder oplysninger om, hvordan lægemidlet indsprøjtes selv, en instruktionstjekliste og en demonstrationsanordning.
English: Aranesp can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating the types of anaemia mentioned above.
Danish: Aranesp udleveres kun efter recept, og behandlingen bør indledes af en læge med erfaring i behandling af de to ovennævnte former for anæmi.
English: • adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly);
Danish: • voksne og børn med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen)
English: Aranesp must not be used in patients who have poorly controlled high blood pressure.
Danish: Aranesp må ikke anvendes til patienter med dårligt reguleret højt blodtryk.
English: In kidney failure patients, the most common side effects with Aranesp (which may affect more than 1 in 10 people) are hypersensitivity (allergy) and hypertension (high blood pressure) while in cancer patients the most common are hypersensitivity and oedema (fluid retention).
Danish: Hos patienter med nyresvigt er de hyppigste bivirkninger ved Aranesp (som optræder hos mere end 1 ud af 10 patienter) overfølsomhed (allergi) og hypertension (forhøjet blodtryk), mens de hyppigste bivirkninger hos kræftpatienter er overfølsomhed og ødem (væskeophobning).
English: Aranesp has been shown to be effective in the treatment of chronic renal failure in four studies involving over 1,200 patients.
Danish: Aranesp er påvist at være effektivt til behandling af kronisk nyresvigt i fire studier, som omfattede 1.200 patienter.
English: Why is Aranesp authorised in the EU?
Danish: Hvorfor blev Aranesp godkendt i EU?
English: For the full list of side effects and restrictions, see the package leaflet
Danish: Den fuldstændige liste over bivirkninger og begrænsninger fremgår af indlægssedlen.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of a hormone called erythropoietin, or by the body not responding well enough to erythropoietin.
Danish: Hos patienter, som får kemoterapi eller har nyreproblemer, kan der opstå anæmi, fordi de mangler hormonet erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på erytropoietin.