FrancophonIA/ELRC3.0 huggingface dataset:
English: Clindamycin Phosphate 10mg G, Tretinoin 0.25mg G
Danish: Clindamycinphosphat 10 mg G, Tretinoin 0,25 mg G
English: Tretinoin 0.025g/100 G Cream
Danish: Tretinoin 0,025 g/100 G Salve
English: Bulgaria неотигазон
Danish: неотигазон
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Retinoids containing medicinal products
Danish: Bilag I Liste over nationalt godkendte lægemidler
English: Adapalene Zentiva Adapalene 0.1% Cream
Danish: Sanofi-Aventis France Adapalene Zentiva Adapalene 0,1 %
English: Isotretinoin Alliance Pharmaceuticals Isotretinoin 5mg Capsule Capsule, Soft
Danish: Generis Farmacêutica, S.A. Isotretinoína Generis Isotretinoin 10 mg kapsel
English: Alitretinoin 10mg
Danish: Alitretinoin 10 mg kapsel
English: Erythromycin 20mg G, Isotretinoin 0.05mg G Gel
Danish: Erythromycin 20 mg G, Isotretinoin 0,05 mg G
English: Clindamycin 10mg G, Tretinoin 0.25mg G Gel
Danish: Clindamycin 10 mg G, Tretinoin 0,25 mg G
English: Meda Pharma Sia Treclinac
Danish: Meda Pharma Sia
English: Fidia Farmaceutici S.P.A
Danish: Fidia Farmaceutici S.P.A Aisoskin
English: Isotretinoin 1mg G Cream
Danish: Isotretinoin 1 mg G Salve
English: Tretinoin 0.25mg G
Danish: Tretinoin 0,25 mg G Salve
English: Keracutan
Danish: Fasker
English: Isotretinoin Ratiopharm Isotretinoin 20mg
Danish: Isotretinoïne Mylan Isotretinoin 20 mg kapsel
English: Aebe
Danish: Zanea
English: Tretinoin 0.5mg/Mg Cream
Danish: Tretinoin 0,5 mg/Mg
English: Tretinoin 0.03g/100 G, Urea 12g/100 G
Danish: Louis Widmer Gmbh At Keratosis + Tretinoin Tretinoin 0,03 g/100 G, Urea 12 g/100 G
English: Ciscutan
Danish: Soriatane
English: Orifarm Generics A/S
Danish: Orifarm Generics A/S Isotretinoin Orifarm Isotretinoin 10 mg kapsel
English: Curacné
Danish: Acicutan
English: Stiefel Laboratories Toctino
Danish: Laboratoires Bailleul Sa Contracne
English: Tretinoin 0.05g/100 G Cream
Danish: Tretinoin 0,05 g/100 G Salve
English: Tretinoin
Danish: Treticlin
English: Isosupra Lidose Isotretinoin 8mg Capsule Capsule, Hard
Danish: Isotretinoína Aurovitas Isotretinoin 10 mg kapsel
English: Bexarotene 75mg Capsule
Danish: Acitretin 25mg kapsel
English: Isotretinoin 0.5mg G
Danish: Isotretinoin 0,5 mg G Salve
English: This was switched to a full marketing authorisation on 8 January 2014.
Danish: Den blev ændret til en fuldstændig markedsføringstilladelse den 8. januar 2014.
English: It is available as capsules and sachets (250 and 500 mg).
Danish: Det fås som kapsler og breve (250 og 500 mg).
English: This type of epilepsy first appears in young children during the first year of life.
Danish: Denne type epilepsi forekommer første gang hos små børn i løbet af det første leveår.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Danish: Det primære effektmål var antallet af patienter, som »responderede« på behandlingen.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Diacomit on 4 January 2007.
Danish: Europa-Kommissionen udstedte en betinget markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Diacomit den 4. januar 2007.
English: The dose of valproate does not normally need to be adjusted.
Danish: Dosis af valproat kræver normalt ingen justering.
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Diacomit.
English: A patient was classified as a ‘responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Danish: En patient blev klassificeret som »responderende«, hvis antallet af anfald i løbet af den anden måned af behandlingen var mindst 50 % lavere end antallet i måneden inden behandlingens start.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Danish: Efter at behandlingen med Diacomit påbegyndes, skal dosis af clobazam muligvis nedsættes.
English: GABA is the main substance in nerve cells responsible for reducing the electrical activity of the brain.
Danish: GABA er hovedstoffet i de nerveceller, der er ansvarlige for at reducere den elektriske aktivitet i hjernen.
English: Other information about Diacomit
Danish: Andre oplysninger om Diacomit
English: Treatment starts with a dose of 20 mg per kg bodyweight, which is gradually increased to the recommended dose over a number of weeks depending on the patient's age.
Danish: Behandlingen indledes med en dosis på 20 mg pr. kg. legemsvægt, som gradvist øges til den anbefalede dosis i løbet af et antal uger afhængig af patientens alder.
English: EPAR summary for the public stiripentol
Danish: EPAR - sammendrag for offentligheden stiripentol
English: More patients responded to treatment with Diacomit than to placebo.
Danish: Der var flere patienter, der responderede på behandling med Diacomit end med placebo.
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Danish: CHMP konkluderede, at der var påvist effekt af Diacomit til SMEI, selv om undersøgelserne var begrænsede og ikke varede så længe, som udvalget havde forventet.
English: Diacomit has been studied in two main studies involving 65 children between three and 18 years of age.
Danish: Diacomit blev undersøgt i to hovedundersøgelser, som omfattede 65 børn i alderen tre til 18 år.
English: The main studies of Diacomit were in children over three years of age.
Danish: Hovedundersøgelserne af Diacomit omfattede børn over tre år.
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Danish: Det har i forsøgsmodeller vist sig at øge niveauet af en »neurotransmitter« kaldet gammaaminosmørsyre (GABA) i hjernen.
English: Diacomit was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety.
Danish: Diacomit blev oprindeligt godkendt under »særlige omstændigheder«, eftersom der afventedes yderligere dokumentation om lægemidlet, navnlig vedrørende dets kort- og langsigtede virkning og sikkerhed.
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Danish: 50 mg pr. kg legemsvægt fordelt på to eller tre doser i løbet af dagen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Diacomit.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Diacomit skal anvendes.
English: Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Danish: Diacomit skal gives sammen med mad, dog ikke mejeriprodukter, kulsyreholdige drikke, frugtjuice eller mad eller drikkevarer, der indeholder koffein eller teofyllin (et stof, der blandt andet findes i sort og grøn te).
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Danish: Da antallet af patienter med SMEI er lavt, betragtes sygdommen som »sjælden«, og Diacomit blev udpeget som »lægemiddel til sjældne sygdomme« den 5. december 2001.
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Danish: Diacomit er et antiepileptisk lægemiddel, der indeholder det aktive stof stiripentol.
English: It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.
Danish: Det forstærker endvidere virkningen af andre antiepileptiske lægemidler og reducerer den hastighed, hvormed disse nedbrydes af leveren.
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Danish: Der blev iagttaget lignende resultater i den anden undersøgelse, hvor 67 % responderede på Diacomit (8 ud af 12) og 9 % på placebo (1 ud af 9).
English: The full EPAR for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Diacomit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Danish: I den første undersøgelse responderede 71 % af de patienter, der fik Diacomit, på behandlingen (15 ud af 21) sammenlignet med 5 % i placebogruppen (1 ud af 20).
English: For more information about treatment with Diacomit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Diacomit, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).
Danish: Brevene indeholder et pulver, som anvendes til at fremstille en oral suspension (en væske med partikler af faststoffer).
English: The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Danish: De hyppigste bivirkninger ved Diacomit (som optræder hos flere end 1 ud af 10 patienter) er nedsat appetit, vægttab, søvnløshed, døsighed, ataksi (manglende evne til at koordinere muskelbevægelser), hypotoni (nedsat muskelstyrke) og dystoni (muskellidelser).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Diacomit findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist).
Danish: Behandling med Diacomit må kun gives under overvågning af en læge med speciale i diagnosticering og behandling af epilepsi hos børn (en pædiater eller pædiatrisk neurolog).
English: Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Danish: Diacomit må ikke anvendes til patienter, som har haft psykoser (en alvorlig psykisk tilstand med forvrænget realitetssans) med tilfælde af delirium (en psykisk tilstand med konfusion, ophidselse, rastløshed og hallucinationer).
English: It decided that Diacomit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Diacomit opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Diacomit.
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Danish: Diacomit anvendes til børn med en meget sjælden type epilepsi kaldet »svær myoklon epilepsi i barndommen« (SMEI), også kendt som Dravets syndrom.
English: What is the risk associated with Diacomit?
Danish: Hvilken risiko er der forbundet med Diacomit?
English: Care must be taken when Diacomit is used at the same time as other medicines.
Danish: Diacomit skal anvendes med forsigtighed, når det gives i kombination med andre lægemidler.
English: The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children's existing treatment with clobazam and valproate.
Danish: I undersøgelserne sammenlignedes effektiviteten af Diacomit som kapsler eller breve med placebo (en virkningsløs behandling), når disse blev givet som tillægsbehandling til den behandling, barnet i forvejen fik med clobazam og valproat.
English: For the full list of all side effects reported with Diacomit, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Diacomit fremgår af indlægssedlen.
English: Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Danish: Diacomit anvendes som tillægsbehandling til clobazam og valproat (andre epilepsilægemidler) til behandling af generaliserede tonisk-kloniske anfald (alvorlige krampeanfald med tab af bevidsthed) i tilfælde, hvor disse ikke kan kontrolleres tilstrækkeligt med clobazam og valproat.
English: Why has Diacomit been approved?
Danish: Hvorfor blev Diacomit godkendt?
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Danish: Det vides ikke helt, præcist hvordan stiripentol, som er det aktive stof i Diacomit, virker som lægemiddel mod epilepsi.
English: What is Diacomit?
Danish: Hvad er Diacomit?
English: See the package leaflet for the full list of restrictions.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: What is Diacomit used for?
Danish: Hvad anvendes Diacomit til?
English: How has Diacomit been studied?
Danish: Hvordan blev Diacomit undersøgt?
English: Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Danish: Lægemidlet må kun gives til små børn, hvis diagnosen SMEI er blevet bekræftet.
English: What benefit has Diacomit shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Diacomit?
English: How is Diacomit used?
Danish: Hvordan anvendes Diacomit?
English: How does Diacomit work?
Danish: Hvordan virker Diacomit?
English: 500 mg Powder for concentrate for solution for infusion
Danish: 500 mg Pulver til koncentrat til infusionsvæske, opløsning
English: 150 (3x50) tablets multipack
Danish: 150 (3 pakker af 50) tabletter
English: Powder for oral suspension bottle (HDPE)
Danish: Oral anvendelse flaske (HDPE)
English: Packaging Content (concentration)
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (koncentration)
English: Do not take a smaller amount.
Danish: Tag ikke en mindre mængde.
English: This will usually take about two minutes.
Danish: Det varer sædvanligvis ca. to minutter.
English: Subsequent treatment should be symptomatic and supportive.
Danish: Efterfølgende behandling skal være symptomatisk og støttende.
English: This will ensure that your medicine works properly.
Danish: Det vil sikre, at dit lægemiddel virker korrekt.
English: Contact a doctor if you are in doubt.
Danish: Kontakt en læge, hvis du er i tvivl.
English: Plasma protein binding is on average 85-90%.
Danish: Den gennemsnitlige plasmaprotein-binding er 85-90 %.
English: In case of short-term overdose no emergency medical treatment is required.
Danish: I tilfælde af en kortvarig overdosering kræves der ingen medicinsk nødbehandling.
English: The usual duration of treatment is 6 weeks.
Danish: Den sædvanlige behandlingsvarighed er 6 uger.
English: Keep taking your medicine until your doctor tells you to stop, even if you feel better.
Danish: Fortsæt med at tage din medicin, indtil din læge beder dig om at stoppe, også selv om du har det bedre.
English: In particular:
Danish: Vær især opmærksom på:
English: The effects of these illnesses can be much more severe during treatment with this medicine.
Danish: Disse sygdomme kan blive meget mere alvorlige under behandlingen med denne medicin.
English: Press it gently against the roof of your mouth with your tongue until it has dissolved completely (this usually takes about two minutes).
Danish: Tryk den forsigtigt mod toppen af munden med tungen, indtil den er helt opløst (det varer sædvanligvis ca. to minutter).
English: The use of this medicine in children younger than 18 years of age has not yet been studied.
Danish: Brug af denne medicin til børn under 18 år er endnu ikke undersøgt.
English: The relevance of this to man has not been established.
Danish: Relevansen af dette for mennesker er ikke klarlagt.
English: Take the carton and this leaflet with you if possible.
Danish: Tag kartonen og denne indlægsseddel med dig, hvis muligt.
English: In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure.
Danish: For patienter, der ikke har haft disse sygdomme skal deres vaccinestatus kontrolleres, og der skal tages særligt hensyn for at undgå eksponering.
English: Your treatment should last about 6 to 12 weeks.
Danish: Behandlingen bør vare ca. 6 til 12 uger.
English: In case your symptoms do not get better in the first 6 weeks of treatment, you may need to take this medicine for up to 6 more weeks.
Danish: Hvis dine symptomer ikke bliver bedre i løbet af de første 6 ugers behandling, kan det være nødvendigt, at du tage dette lægemiddel i op til 6 uger mere.
English: However, no systematic data are available.
Danish: Der foreligger imidlertid ingen systematiske data.
English: Interference with serological testing
Danish: Interferens med serologiske tests
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 °C.
English: The symptoms of some infections can be unusual or less noticeable.
Danish: Symptomerne på nogle infektioner kan være usædvanlige eller mindre mærkbare.
English: Please also report your vaccination status to your doctor.
Danish: Du skal også oplyse din læge om din vaccinestatus.
English: Symptoms of infections can be atypical or masked.
Danish: Symptomerne på infektioner kan være atypiske eller maskerede.
English: If you have any of the conditions mentioned above you may be at increased risk of side effects.
Danish: Hvis du har nogle af de ovennævnte lidelser, kan din risiko for bivirkninger være øget.
English: If you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed.
Danish: Hvis du har taget for mange smeltetabletter på én gang, skal du tage din næste dosis som foreskrevet.
English: The following side effects have been reported during the use of Jorveza:
Danish: De følgende bivirkninger er blevet rapporteret under brugen af Jorveza:
English: − diuretics (to remove excess fluid from the body).
Danish: − diuretika (for at fjerne overskydende væske fra kroppen).
English: Budesonide is excreted in human milk (data on excretion after inhalative use is available).
Danish: Budesonid udskilles i human mælk (data for ekskretion efter inhalation er tilgængelig).
English: Your doctor will decide how long you are to continue the treatment, depending on your condition and your response to the treatment.
Danish: Din læge vil beslutte, hvor længe du skal fortsætte med behandlingen, og det afhænger af din tilstand og dit respons på behandlingen.
English: Some of these medicines may increase the effects of Jorveza and your doctor may wish to monitor you carefully if you are taking these medicines.
Danish: Nogle af disse lægemidler kan øge virkningen af Jorveza, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler.
English: If you miss a dose, just take the next dose at the usual time.
Danish: Hvis du glemmer en dosis, skal du bare tage din næste dosis på det sædvanlige tidspunkt.
English: The antibody response to other vaccines may be diminished.
Danish: Antistofresponset på andre vacciner kan være nedsat.
English: The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines.
Danish: Samtidig administration af levende vacciner og glukokortikosteroider bør undgås, da dette sandsynligvis reducerer immunresponset på vacciner.
English: This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 2,6 % af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: It is important that you do not stop taking your medicine without talking to your doctor.
Danish: Det er vigtigt, at du ikke stopper med at tage din medicin uden at kontakte lægen.
English: White, round, biplane orodispersible tablet, with diameter of 7.1 mm and height of 2.2 mm.
Danish: Hvid, rund, biplan smeltetablet, diameter på 7,1 mm og højde på 2,2 mm.
English: − Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections.
Danish: - Undgå kontakt med mennesker, der har skoldkopper eller herpes zoster (helvedesild), hvis du ikke har haft disse infektioner.
English: The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 33, occurring in 27 out of 87 patients (31%).
Danish: Det samlede antal infektioner (herunder dem, der blev diagnosticeret ved endoskopi og histologi uden symptomer) var 33, som optrådte hos 27 ud af 87 patienter (31 %).
English: Sodium hydrogen carbonate Sucralose
Danish: Natriumhydrogencarbonat Sucralose
English: There should be at least 30 minutes before eating or drinking or performing oral hygiene.
Danish: Der skal gå mindst 30 minutter før indtagelse af mad eller drikke eller udførelse af mundhygiejne.
English: Oestrogens, oral contraceptives
Danish: Østrogener, orale kontraceptiva
English: Budesonide had no mutagenic effects in a number of in vitro and in vivo tests.
Danish: Budesonid havde ingen mutagene virkninger i en række in vitro og in vivo tests.
English: It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it will dissolve.
Danish: Den skal placeres på spidsen af tungen og forsigtigt trykkes mod toppen af munden, hvor den opløses.
English: Increased risk of infection
Danish: Øget infektionsrisiko
English: If you have a kidney problem, your doctor will decide if Jorveza is suitable for you.
Danish: Hvis du har et nyreproblem, vil din læge beslutte, om Jorveza er egnet til dig.
English: Patients showed a 35% increase in peak plasma concentrations and a 60% increase in AUC0-12 compared to healthy subjects.
Danish: Patienterne viste en 35 % stigning i maksimale plasmakoncentrationer, og en 60 % stigning i AUC0-12, sammenlignet med raske forsøgspersoner.
English: − clarithromycin, an antibiotic medicine used to treat infections
Danish: − clarithromycin, et antibiotikum, der anvendes til behandling af infektioner
English: Jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when you take this medicine at high doses and over a long time (see section 4).
Danish: Jorveza kan forårsage bivirkninger, der er typiske for kortikosteroide lægemidler, og kan påvirke alle dele af kroppen, især når du tager denne medicin i høje doser og over lang tid (se pkt.
English: Budesonide passes in small amounts into the breast milk.
Danish: Budesonid passerer i små mængder over i modermælken.
English: Pseudotumor cerebri including papilloedema in adolescents
Danish: Pseudotumor cerebri inklusiv papilødem hos unge