FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg aripiprazol.
English: Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Danish: Aripiprazole Accord 15 mg tabletter: Hver tablet indeholder 15 mg aripiprazol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg aripiprazol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg aripiprazol.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Accord 15 mg tabletter aripiprazol
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Accord 5 mg tabletter aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Accord 10 mg tabletter aripiprazol
English: Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Danish: Lyserøde, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A10” på den ene side og jævne på den anden.
English: • hiccups.
Danish: • hikke.
English: Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Danish: Blå, bikonvekse tabletter med modificeret rektangulær form, uden overtræk, ca. 8,1 mm lange og 4,6 mm brede, præget med “A5” på den ene side og jævne på den anden.
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Danish: EU/1/15/1045/019 14x1 tabletter EU/1/15/1045/020 28x1 tabletter EU/1/15/1045/026 49x1 tabletter EU/1/15/1045/021 56x1 tabletter EU/1/15/1045/022 98x1 tabletter
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Danish: EU/1/15/1045/001 14x1 tabletter EU/1/15/1045/002 28x1 tabletter EU/1/15/1045/023 49x1 tabletter EU/1/15/1045/003 56x1 tabletter EU/1/15/1045/004 98x1 tabletter
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Danish: EU/1/15/1045/013 14x1 tabletter EU/1/15/1045/014 28x1 tabletter EU/1/15/1045/025 49x1 tabletter EU/1/15/1045/015 56x1 tabletter EU/1/15/1045/016 98x1 tabletter
English: EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Danish: EU/1/15/1045/007 14x1 tabletter EU/1/15/1045/008 28x1 tabletter EU/1/15/1045/024 49x1 tabletter EU/1/15/1045/009 56x1 tabletter EU/1/15/1045/010 98x1 tabletter
English: Hyponatremia Anorexia Weight decreased Weight gain
Danish: Hyponatriæmi Anoreksi
English: 11 April 2012
Danish: Den 11. april 2012
English: The withdrawal letter can be found here.
Danish: Brevet om tilbagetrækningen kan ses her.
English: EMEA/H/C/000169/WS/132/G
Danish: EMEA/H/C/000169/WS/132/G EMEA/H/C/000255/WS/132/G
English: About half of the patients took the capsule, and half were tre for 76 weeks.
Danish: Ca. halvdelen af patienterne brugte kapslerne, og halvdelen depotplastret, i en periode på 76 uger.
English: es this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser?
English: The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required.
Danish: Udvalget fandt derfor, at de farmakokinetiske data ikke er tilstrækkelige til at drage konklusioner om effektiviteten af plastret, og at det vil være nødvendigt med supplerende oplysninger.
English: What did the company present to support its application?
Danish: Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
English: The full European Public Assessment Report for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Prometax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
English: Exelon and Prometax are medicines containing the active substance rivastigmine.
Danish: Exelon og Prometax er lægemidler, der indeholder det aktive stof rivastigmin.
English: y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Exelon eller Prometax.
English: The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Exelon findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What was the recommendation of the CHMP at that tim
Danish: Hvad anbefalede CHMP på daværende tidspunkt?
English: uated the er the CHMP had o the questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene, var der stadig nogle uafklarede punkter.
English: The company had presented pharmacokinetic data showing that, when using the patch, rivastigmine levels in patients with Parkinson's disease were similar to the levels seen in patients with Alzheimer's, but the CHMP noted that the dementia in the two diseases was different and could respond differently to treatment.
Danish: Virksomheden havde fremlagt farmakokinetiske data, der viste, at koncentrationen af rivastigmin ved brug af depotplasteret var den samme hos patienter med Parkinsons sygdom som hos patienter med Alzheimers sygdom, men CHMP bemærkede, at demens ved de to sygdomme er forskellig og kan reagere forskelligt på behandlingen.
English: a clinical trial and need more information about your treatment, contact the doctor who is
Danish: Hvis du deltager i en klinisk undersøgelse med Exelon eller Prometax og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: How far into the evaluation was the applicatio
Danish: Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
English: s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour.
Danish: Alle former af lægemidlet kan anvendes til behandling af let til middelsvær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Exelon/Prometax, depotplaster, til behandling af let til middelsvær demens ved Parkinsons sygdom er usikre og ikke er større end risiciene.
English: The transdermal patches of Exelon and Prometax were also expected to be used to treat mild to moderately severe dementia associated with Parkinson's disease, which can already be treated using the capsules and oral solution.
Danish: Exelon og Prometax, depotplastre, forventedes også anvendt til behandling af let til middelsvær demens ved Parkinsons sygdom, som i forvejen kan behandles med kapslerne og den orale opløsning.
English: The company presented the results of a study designed to assess the long-t and transdermal patch in 583 patients with mild to moderately severe dementia ass Parkinson's disease.
Danish: Virksomheden fremlagde resultaterne af en undersøgelse af de langsigtede virkninger af kapslen og depotplastret hos 583 patienter med let til middelsvær demens ved Parkinsons sygdom.
English: The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl
Danish: Det aktive stof i Exelon og Prometax, rivastigmin, blokerer de enzymer, der nedbryder acetylcholin: acetylcholinesterase og butyrylcholinesterase.
English: What are Exelon and Prometax?
Danish: Hvad er Exelon og Prometax?
English: capsules, an oral solution and transdermal patches (patches tha Exelon and Prometax have been authorised in the EU since May 1998.
Danish: Exelon og Prometax har været godkendt i EU siden maj 1998.
English: There are no consequences on the use of Exelon and Prometax in their author
Danish: Afgørelsen vil ikke få konsekvenser for anvendelsen af Exelon eller Prometax til de godkendte indikationer.
English: How are Exelon and Prometax expected to work?
Danish: Hvordan forventes Exelon og Prometax at virke?
English: On 14 March 2012, Novartis Europ and Prometax, to add the use of the transdermal patch for the treatment of mild to dementia in patients with Parkinson's disease.
Danish: Den 14. marts 2012 meddelte Novartis Europharm Ltd. officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om udvidelse af indikationen for Exelon og Prometax, depotplaster, til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: What is happening with Exelon and Prometax in their authorised ised indications.
Danish: Hvad sker der med Exelon og Prometax til de godkendte indikationer?
English: What were Exelon and Prometax expected to be used for?
Danish: Hvad forventedes Exelon og Prometax anvendt til?
English: choline to be increased in the brain, helping to reduce the symptoms of dementia in patients with Parkinson's disease.
Danish: Derved mindskes symptomerne på demens ved Parkinsons sygdom.
English: The Committee was concerned that the new study was not sufficient to conclude on of the patch in patients with dementia associated with Pa e the reasons given by the company for withdrawing the d that it decided to withdraw the application after the CHMP de on a favourable approval additional data was required, which could not be generated within the allowed timeframe.
Danish: I sit officielle brev erklærede virksomheden, at den ville trække ansøgningen tilbage, efter at CHMP havde meddelt, at godkendelse ville kræve fremlæggelse af supplerende oplysninger, hvilket ikke var muligt inden for den fastlagte frist.
English: They are available as t deliver the medicine across the skin).
Danish: De leveres som kapsler, oral opløsning og depotplaster (et plaster, der afgiver et lægemiddel gennem huden).
English: erm effects of the capsule ociated with ated with the patch, he capsules, but the company later extended its aim to include the assessment of the benefits and risks of the ase.
Danish: Undersøgelsen var oprindeligt sat i gang for at vurdere sikkerheden af kapslerne på langt sigt, men virksomheden udvidede senere formålet, så den også omfattede fordele og risici ved depotplastret til behandling af demens ved Parkinsons sygdom.
English: The company also presented a ‘pharmacokinetic' analysis of the way rivastigmine from the patch is handled in the body th what is seen n when it was withdrawn?
Danish: Virksomheden fremlagde desuden en ”farmakokinetisk” analyse af, hvordan rivastigmin optræder i kroppen, når det gives til patienter med demens ved Parkinsons sygdom, sammenlignet med forholdene hos patienter med Alzheimers demens.
English: Based on the review of the data and the company's response to the CHMP lists time of the withdrawal, the CHMP had some concerns and was of the provisional o transdermal patch could not have been approved for the treatment of mild to
Danish: Efter gennemgang af de foreliggende oplysninger og virksomhedens besvarelse af CHMP's spørgsmål havde udvalget visse betænkeligheder.
English: Withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax harm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for an extension of indication for Exelon moderately severe
Danish: Tilbagetrækning af ansøgningen om ændring af markedsføringstilladelsen for Exelon ogPrometax (rivastigmin)
English: The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other).
Danish: rotransmitteren acetylcholin (et signalstof, som anvendes af nervecellerne til indbyrdes kommunikation).
English: For all epoetins
Danish: For alle epoetiner
English: Adopted at the 3-6 July 2017 PRAC
Danish: Vedtaget på PRAC's møde 3.-6. juli 2017
English: For topical formulations, no action is required.
Danish: Ingen handling er påkrævet for topiske formuleringer.
English: For all epoetins - 4.4.
Danish: For alle epoetiner - 4.4.
English: • Drugs stimulating vasopressin release include:
Danish: • Lægemidler, der stimulerer frigivelsen af vasopressin, omfatter:
English: <Product name> tonicity: XXX
Danish: <Lægemidlets navns> tonicitet: XXX
English: The wording below should be adapted at an individual product level and therefore, the type of variation to be submitted should be agreed with the relevant National Competent Authority (NCA) prior to the submission.
Danish: Ordlyden nedenfor skal tilpasses for de enkelte lægemidler, og derfor skal den type ændring, der skal indsendes, aftales med den relevante nationale kompetente myndighed (NCA) inden indsendelsen.
English: Blood pressure and renal function (s-creatinine) should therefore be routinely checked.
Danish: Blodtrykket og nyrefunktionen (S-kreatinin) bør således kontrolleres regelmæssigt.
English: The doctor may advise that you have your blood pressure and urine regularly checked.
Danish: Lægen kan råde dig til at få dit blodtryk og din urin kontrolleret regelmæssigt.
English: Section Warnings and precautions - Take special care with <product name>:
Danish: Punktet "Advarsler og forsigtighedsregler" - Vær særligt forsigtig med <lægemidlets navn>:
English: Talk to your doctor before taking <product name>, if you have:
Danish: Kontakt lægen, før du tager <lægemidlets navn>, hvis du har:
English: Signs of scleroderma renal crisis include increased blood pressure and decreased urine production.
Danish: Tegn på sklerodermisk nyrekrise omfatter forhøjet blodtryk og nedsat urinproduktion.
English: Unless compatibility with other solutions/drugs has been confirmed, the infusion solution must always be administered separately.
Danish: Medmindre forligeligheden med andre opløsninger/lægemidler er bekræftet, skal infusionsvæske, opløsningen altid indgives separat.
English: The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)
Danish: Den laveste risiko er rapporteret hos patienter med begrænset systemisk sklerose (2 %) og juvenil systemisk sklerose (1 %).
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of <product name>, treatment with <product name> must not be restarted in this patient at any time.
Danish: Hvis patienten har udviklet en svær kutan bivirkning såsom SJS eller TEN på grund af brugen af <lægemidlets navn>, må behandling med <lægemidlets navn> ikke genoptages hos denne patient på noget tidspunkt.
English: If signs and symptoms suggestive of these reactions appear, <product name> should be withdrawn immediately and an alternative treatment considered.
Danish: Hvis der opstår tegn og symptomer, som tyder på sådanne reaktioner, skal <lægemidlets navn> straks seponeres, og en alternativ behandling skal overvejes.
English: Stop using <product name> if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge <lægemidlets navn>, hvis du udvikler disse symptomer, og kontakt straks din læge eller søg lægehjælp.
English: These may be associated with fever, headaches and body aches
Danish: Disse kan være forbundet med feber, hovedpine og smerter i kroppen
English: Scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder).
Danish: Sklerodermisk nyrekrise hos patienter, som allerede lider af sklerodermi (en autoimmun sygdom).
English: • Anaphylactic reactions
Danish: • Anafylaktiske reaktioner
English: Medicinal products concerned: systemic formulations of prednisolone-containing medicinal products and prednisone-containing medicinal products in doses which provide a systemic concentration equivalent to more than 15 mg prednisolone daily
Danish: Berørte lægemidler: systemiske formuleringer af lægemidler, der indeholder prednisolon, og lægemidler, der indeholder prednison, i doser, som giver en systemisk koncentration svarende til over 15 mg prednisolon dagligt.
English: When renal crisis is suspected, blood pressure should be carefully controlled.
Danish: Hvis der er formodning om en nyrekrise, skal blodtrykket kontrolleres nøje.
English: The highest risk has been reported in patients with diffuse systemic sclerosis.
Danish: Den højeste risiko er rapporteret hos patienter med diffus systemisk sklerose.
English: For all epoetins except darbepoetin alfa and methoxy polyethylene glycol-epoetin beta: 4.8.
Danish: For alle epoetiner undtagen darbepoetin alfa og methoxypolyethylenglycol-epoetin beta: 4.8.
English: Intravenous (IV) fluids containing electrolytes and/or carbohydrates - Hyponatraemia (EPITT no 18631)
Danish: Intravenøse (IV) væsker, som indeholder elektrolytter og/eller kulhydrater - hyponatræmi (EPITT nr. 18631)
English: Amoxicillin + clavulanic acid
Danish: Amoxicillin + clavulansyre
English: Comment under the table: *see section “Description of selected adverse reactions” below and sec tion
Danish: Bemærkning under tabellen: *Se punktet "Beskrivelse af udvalgte bivirkninger" nedenfor og pkt.
English: Frequency ‘unknown': Scleroderma renal crisis* *see section c)
Danish: Hyppighed ikke kendt: Sklerodermisk nyrekrise* *Se punkt c)
English: Undesirable effects - table of ADRs - both for Chronic renal failure patients and for Cancer patients:
Danish: Bivirkninger - tabel over bivirkninger - både for patienter med kronisk nyresvigt og for kræftpatienter:
English: Adverse reaction (MedDRA term)
Danish: Bivirkning (MedDRA-term)
English: Scleroderma (also known as systemic sclerosis, an autoimmune disorder) because daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis.
Danish: Sklerodermi (også kendt som systemisk sklerose, en autoimmun sygdom), da daglige doser på 15 mg eller derover kan øge risikoen for en alvorlig komplikation kaldet sklerodermisk nyrekrise.
English: Skin and subcutaneous tissue disorders - (frequency not known) - SJS/TEN, erythema multiforme, blistering, skin ex foliation*
Danish: Hud og subkutant væv - (hyppighed ikke kendt) - SJS/TEN, erythema multiforme, blærer, hudeksfoliering*
English: Undesirable effects Tabulated list of adverse reactions System Organ Class
Danish: Bivirkninger Tabel over bivirkninger Systemorganklasse
English: The adjustments are based on the existing SmPC for a glucose 5% IV fluid.
Danish: Justeringerne er baseret på det eksisterende produktresumé for en IV-væske med 5 % glukose.
English: The visual signs of incompatibility are e.g. precipitation, clouding, and discoloration.
Danish: De visuelle tegn på uforligelighed er f.eks. udfældning, uklarheder og misfarvning.
English: Amongst the different subpopulations the occurrence of scleroderma renal crisis varies.
Danish: Forekomsten af sklerodermisk nyrekrise varierer blandt de forskellige underpopulationer.
English: Hyponatraemic encephalopathy**
Danish: Hyponatræmisk encephalopati**
English: Fulvestrant - Anaphylactic reaction (EPITT no 18832)
Danish: Fulvestrant - anafylaktisk reaktion (EPITT nr. 18832)
English: Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.9 - 4.5).
Danish: Der er uforligelighed med alle infusionsvæske, opløsninger/lægemidler, som er fysisk eller kemisk ustabile ved opløsningernes pH (f.eks. penicilliner og heparinopløsninger), specielt i kombination med opløsninger, som er justeret til en basisk pH (ciprofloxacin-opløsningernes pH: 3,9-4,5).
English: Monitoring of serum sodium is particularly important for hypotonic fluids.
Danish: Monitorering af serumnatrium er særlig vigtigt for hypotone væsker.
English: If you develop a serious rash or another of these skin symptoms, stop taking <product name> and contact your doctor or seek medical attention immediately.
Danish: Hvis du udvikler et alvorligt udslæt eller får andre af disse hudsymptomer, skal du stoppe med at tage <lægemidlets navn> og straks kontakte din læge eller søge lægehjælp.
English: • other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling.
Danish: • andre alvorlige hudreaktioner kan omfatte ændringer i hudfarven, buler under huden, blærer, pusfyldte blærer, hudafskalning, rødme, smerter og kløe.
English: Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone.
Danish: Der skal udvises forsigtighed hos patienter med systemisk sklerose, da der er observeret en øget forekomst af (muligvis fatal) sklerodermisk nyrekrise med hypertension og nedsat urinudskillelse ved en daglig dosis prednisolon på 15 mg eller derover.
English: SmPC for IV fluids without glucose
Danish: Produktresumé for IV-væsker uden glukose
English: Summary of product characteristics (SmPC) for fluids containing glucose
Danish: Produktresumé (SmPC) for væsker, der indeholder glukose
English: Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.
Danish: Alt afhængigt af opløsningens tonicitet, infusionsmængden og -hastigheden samt patientens underliggende kliniske tilstand og evne til at metabolisere glukose kan intravenøs administration af glukose medføre elektrolytforstyrrelser, hyppigst hypo- eller hyperosmotisk hyponatræmi.
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Danish: • Allergiske reaktioner (overfølsomhed), der kan omfatte hævelser i ansigt, læber, tunge og/eller svælg, og som kan være tegn på anafylaktiske reaktioner