FrancophonIA/ELRC3.0 huggingface dataset:
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Danish: Før der indledes en behandling med bisphosphonater hos patienter med samtidige risikofaktorer (f.eks. cancer, kemoterapi, stråleterapi, kortikosteroidbehandling eller dårlig tandhygiene), bør det overvejes at undersøge tænderne og gennemføre forebyggende tandpleje.
English: • Alendronate HEXAL tablets should only be swallowed on rising for the day with a whole glass of water (not less than 200 ml or 7 fl. oz).
Danish: • Alendronat HEXAL-tabletterne skal indtages med et helt glas postevand (mindst 200 ml), så snart patienten er stået op om morgenen.
English: Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Danish: Hos cancerpatienter, der blev behandlet med primært intravenøse bisphosphonater, er der rapporter om osteonekrose af kæben, generelt forbundet med tandudtrækning og/eller lokal infektion (herunder osteomyelitis).
English: Uncommon: ≥ 1/1,000 - < 1/100
Danish: Ikke almindelig: ≥ 1/1.000, < 1/100.
English: Prophylaxis of glucocorticoid-induced osteoporosis.
Danish: Profylakse mod glukokotikoidudløst osteoporose.
English: Vomiting irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach black or tarlike stools rash itching redness of the skin
Danish: Ikke almindelig kvalme, opkastning, irritation eller betændelse i struben (oesophagus - det rør, som forbinder din mund med din mave) eller i maven, sortfarvet eller tjærelignende afføring.
English: Alendronic acid
Danish: Alendron-HEXAL
English: Musculoskeletal and connective tissue disorders:Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Danish: Der er rapporter om osteonekrose i kæben hos patienter, som blev behandlet med bisphosphonater.
English: It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendronate HEXAL if taken at the same time.
Danish: Det kan muligvis have indflydelse på optagelsen af Alendronat HEXAL, hvis det indtages samtidig med kalciumtilskud, syrehæmmende medicin eller anden medicin, der indtages gennem munden.
English: Belgium - Alendronate Sandoz Denmark - Alendonicht
Danish: Alendronate Sandoz
English: HOW TO STORE ALENDRONATE HEXAL
Danish: SÅDAN OPBEVARER DU Alendronat HEXAL
English: Microcrystalline cellulose
Danish: Mikrokrystallinsk cellulose Lactosemonohydrat Croscarmellosenatrium Magnesiumstearat
English: MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: Marketing Authorisation Holder and Manufacturer <[See Annex I - To be completed nationally]>
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se bilag I - Udfyldes nationalt]>
English: HOW TO TAKE ALENDRONATE HEXAL
Danish: SÅDAN SKAL DU TAGE ALENDRONAT HEXAL
English: Common (≥1/100, <1/10): Musculoskeletal pain (bones, muscles or joints) Rare (≥1/10,000, <1/1000): Severe musculoskeletal (bone, muscle or joint pain) (see section 4.4) Unknown frequency: Osteonecrosis
Danish: Sjælden (≥1/10.000 til, <1/1.000): svære muskuloskeletale smerter (knogle-, muskel- eller ledsmerter) (se pkt.
English: HEXAL A/S Kanalholmen 8-12, 2650 Hvidovre, Denmark
Danish: HEXAL A/S Kanalholmen
English: Dysphagia
Danish: Diarré
English: BEFORE YOU TAKE ALENDRONATE HEXAL
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ALENDRONAT HEXAL
English: Post-menopausal osteoporosis:
Danish: Glukokortikoidudløst osteroporose:
English: Lactose monohydrate
Danish: Glukokotikoidudløst osteoporose
English: Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronate HEXAL.
Danish: Der kan opstå irritation, betændelse eller sår i struben (oesophagus - det rør, som forbinder din mund med din mave) ofte forbundet med symptomer som smerter i brystet, halsbrand eller besvær med at synke eller smerter efter synkning.
English: Oral use blister (PVC/alu)
Danish: Oral anvendelse blister (PVC/alu) 60 tabletter
English: (Invented) name Strength Pharmaceutical Form
Danish: EMA's nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: EMA Number
Danish: Pakningsstørrelse
English: 11 October 2013 EMA/584237/2013
Danish: Den 11. oktober 2013 EMA/584237/2013
English: In order to ensure that these patients will not be left without treatment, national competent authorities may make these medicines available under controlled conditions.
Danish: For at sikre, at disse patienter ikke er uden behandlingsmulighed, kan de nationale kompetente myndigheder gøre disse lægemidler tilgængelige under kontrollerede betingelser.
English: The Committee also considered the advice from a group of experts in the treatment of infections.
Danish: Udvalget tog desuden hensyn til råd fra en ekspertgruppe vedrørende behandling af infektioner.
English: European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
Danish: Den europæiske lovgivning kræver, at der iværksættes en koordineret europæisk indsats, når en medlemsstats myndigheder griber ind over for et lægemiddel, der er godkendt i mere end ét land.
English: The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende oralt ketoconazol blev indledt i juli 2011 på anmodning af Frankrig i medfør af artikel 31 i direktiv 2001/83/EF.
English: • The onset of hepatotoxicity occurred generally between 1 and 6 months after starting treatment, but has also been reported earlier than 1 month after starting treatment, and at the recommended daily dose of 200 mg.
Danish: • Hepatotoksicitet satte sædvanligvis ind mellem 1 og 6 måneder efter initiering af behandlingen, men er også beskrevet at indtræde tidligere end en måned efter initiering af behandlingen, og ved den anbefalede daglige dosis på 200 mg.
English: Suspension of marketing authorisations for oral ketoconazole
Danish: Suspendering af markedsføringstilladelserne for ketoconazol til oral anvendelse
English: Oral formulations of ketoconazole have been authorised in the EU via national procedures, and are currently available in several EU Member States under various trade names, including Nizoral and Fungoral.
Danish: Orale formuleringer af ketoconazol har været godkendt i EU via nationale procedurer og markedsføres på nuværende tidspunkt i flere EU medlemsstater under forskellige handelsnavne, herunder Nizoral og Fungoral.
English: • The risk minimisation measures proposed, such as limiting the treatment duration or restricting the use to patients refractory or intolerant to alternative treatments and to physicians experienced in treating rare fungal infections, were not considered sufficient to reduce the risk of hepatotoxicity to an acceptable level.
Danish: • De foreslåede risikominimeringsforanstaltninger såsom begrænsning af behandlingsvarigheden eller begrænsninger i anvendelsen til patienter, der er refraktære eller intolerante over for andre behandlinger, og til læger med erfaring i behandling af sjældne mykoser, blev ikke anset for tilstrækkelige til at nedsætte risikoen for hepatotoksicitet til et acceptabelt niveau.
English: References.
Danish: Litteraturhenvisninger.
English: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.
Danish: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazol and other antifungal drugs.
English: The CHMP was concerned that reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk.
Danish: CHMP var betænkelig ved, at der indkommer indberetninger om leverskader tidligt efter påbegyndelse af behandlingen med de anbefalede doser, og at der ikke kan udpeges foranstaltninger, der nedsætter denne risiko tilstrækkeligt.
English: On 25 July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU).
Danish: Den 25. juli 2013 anbefalede Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker (CHMP), at markedsføringstilladelserne for orale lægemidler indeholdende ketoconazol suspenderes i hele Den Europæiske Union (EU).
English: The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Danish: Gennemgangen af oralt ketoconazol blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog EMA's endelige udtalelse.
English: • Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Danish: • Topikale formuleringer af ketoconazol har meget lav systemisk absorption og kan fortsat anvendes som godkendt på nuværende tidspunkt.
English: The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France.
Danish: Den EU-dækkende gennemgang af oralt ketoconazol blev udløst af suspenderingen af lægemidlet i Frankrig.
English: To lift the suspension, the marketing authorisation holder for oral ketoconazole will have to provide convincing data that identify a group of patients in whom the benefits of the medicine outweigh their risks.
Danish: For at ophæve suspenderingen skal indehaveren af markedsføringstilladelsen for oralt ketoconazol fremlægge overbevisende data, der udpeger en gruppe af patienter, hos hvem fordelene ved lægemidlet overstiger dets risici.
English: There are also inadequate data to support the efficacy of ketoconazole when other treatments have failed or are not tolerated, or resistance has been detected.
Danish: Der er desuden ikke tilstrækkelige data til at underbygge virkningen af ketoconazol, når andre midler har slået fejl eller ikke tolereres, eller der er konstateret resistens.
English: Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Danish: I betragtning af den højere andel af leverskader og tilgængeligheden af andre svampemidler konkluderede CHMP, at fordelene ikke overstiger risiciene.
English: • The efficacy studies on oral ketoconazole are limited and have not been carried out in line with the most recently agreed guidelines2.
Danish: • Undersøgelserne af virkningen af oralt ketoconazol er begrænsede og er ikke udført efter de senest vedtagne retningslinjer2.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 11. oktober 2013 vedtog en endelig beslutning, der er retligt bindende i hele EU.
English: The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.
Danish: CHMP konkluderede, at risikoen for leverskade er større end fordelene ved behandling af svampeinfektioner.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Danish: Agenturets anbefalinger er baseret på en gennemgang foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som gennemgik de foreliggende data om fordelene ved oralt ketoconazol og risikoen for hepatotoksicitet på grundlag af prækliniske og kliniske undersøgelser, spontane caserapporter efter markedsføring, epidemiologiske undersøgelser og den videnskabelige litteratur.
English: The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Danish: Udvalget konkluderede desuden, at den kliniske fordel ved oralt ketoconazol er usikker, da data om dets effektivitet er begrænsede og ikke opfylder dagens standarder, og da der findes andre behandlingsmuligheder.
English: Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Danish: Ketoconazol til oral brug (gennem munden) har været godkendt i EU siden 1981, og senere formuleringer til lokal brug (på huden), såsom cremer, salver og shampooer, er blevet tilgængelige.
English: In June 2011, the French medicines agency concluded that the benefit-risk balance of oral ketoconazole was negative and suspended the existing marketing authorisations in France.
Danish: I juni 2011 konkluderede den franske lægemiddelstyrelse, at benefit/risk-forholdet for oral til ketoconazol var negativt, og suspenderede de eksisterende markedsføringstilladelser i Frankrig.
English: Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
Danish: Læger bør ikke længere ordinere oralt ketoconazol, men gennemgå behandlingsmulighederne for patienten.
English: Consequently, the French agency asked the EMA to carry out a full assessment of the benefitrisk balance of oral ketoconazole-containing medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Danish: Følgelig anmodede den franske lægemiddelstyrelse CHMP om at foretage en fyldestgørende vurdering af benefit/risk-forholdet for lægemidler indeholdende ketoconazol og fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals.
Danish: Efter vurdering af de foreliggende data om risiciene med oralt ketoconazol konkluderede CHMP, at skønt leverskade såsom hepatitis er en kendt bivirkning af svampemidler, var forekomsten og alvorligheden af leverskade med oralt ketoconazol højere end med andre svampemidler.
English: • Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
Danish: • Ketoconazol til oral brug (gennem munden) er blevet suspenderet efter en gennemgang af data, der viser større giftpåvirkning af leveren med dette lægemiddel end med andre svampemidler.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en beslutning, som er gyldige i hele EU.
English: The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.
Danish: Den franske lægemiddelstyrelse ANSM (Agence nationale de sécurité du médicament et des produits de santé), konkluderede, at benefit /risk-forholdet for oralt ketoconazol var negativt på grund af høj forekomst af leverskader i forbindelse med lægemidlet og på baggrund af, at der i dag findes andre behandlingsmuligheder, der anses for sikrere.
English: Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Danish: Formuleringer af ketoconazol til lokal brug (såsom cremer, salmer og shampooer) kan fortsat anvendes, da mængden af ketoconazol, der absorberes til hele kroppen, er meget lav med disse lægemiddelformer.
English: The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Danish: Det Europæiske Lægemiddelagentur er vidende om, at ketoconazol anvendes til behandling af Cushings syndrom, hvilket er et ikke-godkendt formål.
English: • If you are taking topical formulations of ketoconazole (such as creams, ointments and shampoos), you can continue your treatment, as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Danish: • Hvis du får ketoconazol til lokal brug (som creme, salve eller shampoo) kan du fortsætte med at bruge det, da mængden af ketoconazol, der absorberes til hele kroppen, er meget lav med disse lægemiddelformer.
English: Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Danish: Ketoconazol er et lægemiddel, der anvendes til behandling af infektioner forårsaget af svampe, der angriber huden, og gærsvampe.
English: • As oral ketoconazole is no longer recommended, doctors should review patients being treated with this medicine for fungal infections, with a view of stopping treatment or choosing an appropriate alternative treatment.
Danish: • Da anvendelse af oralt ketoconazol frarådes, bør lægerne gennemgå patienter i antimykotisk behandling med dette lægemiddel med henblik på seponering eller valg af passende anden behandling.
English: Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections
Danish: Fordelene ved oral anvendelse af ketoconazol mod svampeinfektioner opvejer ikke risikoen for leverskade
English: Patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments.
Danish: Patienter, der på nuværende tidspunkt bruger oralt ketoconazol mod svampeinfektioner, bør få en ikke-akut tid hos lægen med henblik på drøftelse af andre behandlingsmuligheder.
English: • If you have any questions, you should contact your doctor or pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: • Pharmacists should refer patients with a prescription of oral ketoconazole for fungal infections to their treating doctor.
Danish: • Patienter med recept på oralt ketoconazol mod mykoser bør af apoteket henvises til den behandlende læge.
English: • Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents.1 Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.
Danish: • Skønt det hepatotoksiske potentiale er en klasseeffekt med azol-antimykotika, viser de gennemgåede data, at forekomsten og alvorligheden af hepatotoksicitet er højere med ketoconazol end med andre antimykotika1.
English: • If you are currently taking oral ketoconazole for fungal infections, you should speak to your doctor at a routine appointment to discuss suitable alternative treatments.
Danish: • Hvis du på nuværende tidspunkt bruger oralt ketoconazol mod svampeinfektioner, skal du få en ikke-akut tid hos lægen med henblik på andre behandlingsmuligheder.
English: More information on Amglidia can be found on the Agency's website: ema.europa.eu/Find medicine.
Danish: Yderligere oplysninger om Amglidia findes på agenturets websted under: ema.europa.eu/Find medicine.
English: Information for parents and carers
Danish: Information til forældre og omsorgspersoner
English: • Amglidia is given twice a day.
Danish: • Amglidia indgives to gange dagligt.
English: − strength of Amglidia,
Danish: − Amglidia-styrke,
English: − how many doses are given each day,
Danish: − antal doser, der indgives pr. dag,
English: • The prescription should include all of the following details:
Danish: • Følgende oplysninger bør fremgå af recepten:
English: − volume in ml to be given for each dose,
Danish: − volumen i ml, der skal indgives for hver dosis,
English: Parents and carers should speak to a doctor or pharmacist if they have any questions about the treatment.
Danish: Forældre og omsorgspersoner bør tale med lægen eller apotekspersonalet, hvis de har spørgsmål til behandlingen.
English: The dose is prescribed in millilitre (ml) according to body weight.
Danish: Dosen ordineres i milliliter (ml) ud fra legemsvægt.
English: − daily dose of Amglidia in ml,
Danish: − daglig dosis Amglidia i ml,
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2018 EMA/133231/2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
English: • The choice of the oral syringe depends on the volume per dose:
Danish: • Valget af mundsprøjtestørrelse afhænger af volumen pr. dosis:
English: Guide will increase awareness on the different medicine presentations and help avoid medication errors
Danish: Denne vejledning vil øge bevidstheden om de forskellige styrker og mundsprøjtestørrelser og bidrage til at undgå medicineringsfejl
English: Amglidia is effective in patients with specific genetic mutations (beta-cell ATP-sensitive potassium channel and chromosome 6q24).
Danish: Amglidia er effektivt hos patienter med specifikke genmutationer (den ATP-følsomme kaliumkanal i beta-celler og kromosom 6q24).
English: All healthcare professionals who are expected to prescribe Amglidia (glibenclamide oral suspension) will be provided with a guide to help ensure that the medicine is prescribed and used correctly.
Danish: Alle sundhedspersoner, der forventes at ordinere Amglidia (glibenclamid som oral suspension), vil blive forsynet med en vejledning, der bidrager til at sikre, at lægemidlet ordineres og anvendes korrekt.
English: Dosing errors may occur due to confusion between milligram (mg) and millilitre (ml), or use of incorrect strength or size of syringe and how the dose is measured, which may result in too high or too low blood sugar levels.
Danish: Der kan ske doseringsfejl, hvis man forveksler milligram (mg) med milliliter (ml) eller anvender en forkert styrke eller en forkert mundsprøjtestørrelse eller udmåler dosen forkert, og det kan resultere i for højt eller for lavt blodsukker.
English: The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas.
Danish: Det aktive stof i Amglidia, glibenclamid, er et diabetesmiddel, der tilhører gruppen af sulfonylurinstoffer.
English: Glibenclamide's effect on the KATP channel restores the cells' ability to release insulin into the blood.
Danish: Glibenclamids effekt på KATP-kanalerne retablerer cellernes evne til at frigive insulin i blodet.