FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP harmonised the posology for children, using the patient's weight as the cut-off point to distinguish the dosage for ‘adults and adolescents' (weighing more than 40 kg) from the dosage for children (below 40 kg).
Danish: CHMP harmoniserede doseringen for børn og anvendte patientens vægt som skæringspunkt for at skelne mellem doseringen for "voksne og unge" (som vejer over 40 kg) og doseringen for børn (under 40 kg).
English: (infection of the middle ear), exacerbation (flare up) of bronchitis and pneumonia;
Danish: (mellemørebetændelse), forværring (opblussen) af bronkitis og lungebetændelse;
English: However, the twice-daily dosage can still be used in patients for whom a reduced dose of Augmentin is needed, such as those with problems with their liver or kidneys.
Danish: Doseringen to gange dagligt kan dog stadig anvendes til patienter, der skal have en reduceret dosis Augmentin, f.eks. patienter med lever- eller nyreproblemer.
English: The Committee also harmonised the section listing the types of bacteria against which the medicines is active, and the concentration at which it is effective.
Danish: Udvalget harmoniserede ligeledes punktet med en liste over de bakterietyper, som lægemidlet er aktivt over for, og den koncentration, som det er virksomt i.
English: When Augmentin is absorbed in the body, the amoxicillin component kills the bacteria that are causing the infection, while the clavulanic acid component blocks an enzyme, betalactamase that enable the bacteria to destroy amoxicillin.
Danish: Når Augmentin absorberes i kroppen, dræber amoxicillinkomponenten de bakterier, der er årsag til infektionen, mens clavulansyrekomponenten blokerer et enzym, betalactamase, der gør det muligt for bakterierne at ødelægge amoxicillin.
English: The Committee also recommended that in situations where a higher dose of amoxicillin is required, another preparation of Augmentin should be chosen in order to avoid the patient taking too much clavulanic acid.
Danish: Udvalget anbefalede ligeledes, at man i situationer, hvor en højere dosis amoxicillin er påkrævet, anvender et andet Augmentinpræparat for at undgå, at patienten får for meget clavulansyre.
English: This applies in particular to medicines with a 2:1 or 4:1 ratio, as these, taken at the recommended dose, may not provide a dose of amoxicillin that is sufficient to kill locally prevalent bacteria in areas where there is a high level of resistance to penicillins.
Danish: Dette gælder navnlig for lægemidler med forholdet 2:1 eller 4:1, eftersom disse lægemidler, hvis de tages i den anbefalede dosis, måske ikke giver en amoxicillindosis, der er tilstrækkelig til at dræbe de lokalt fremherskende bakterier i områder med høj penicillinresistens.
English: • infections of the skin and soft tissues (the structures just below the skin);
Danish: • infektioner i hud og bløddele (de strukturer, der ligger lige under huden).
English: Previously, Augmentin tablets and suspensions using a 4:1 ratio had been taken twice daily, however the CHMP agreed that a twice-daily dosage was not appropriate as a standard dosage.
Danish: Tidligere skulle Augmentin tabletter og suspension med forholdet 4:1 tages to gange dagligt, men CHMP besluttede, at doseringen to gange dagligt ikke var velegnet som standarddosering.
English: The CHMP emphasized that the availability of a medicine containing a certain ratio of amoxicillin:clavulanic acid in one country did not mean that this medicine should also be used in another country.
Danish: CHMP understregede, at tilgængeligheden i det ene land af et lægemiddel, der har et bestemt amoxicillin/clavulansyre-forhold, ikke betyder, at dette lægemiddel også skal bruges i et andet land.
English: The CHMP harmonised the information in the SPC on the potential interaction of Augmentin with other medicines, and with some laboratory tests.
Danish: CHMP harmoniserede informationen i produktresuméet om Augmentins potentielle interaktion med andre lægemidler og med visse laboratorietest.
English: Augmentin, also known as ‘coamoxiclav', contains two active substances: amoxicillin, which is an antibiotic belonging to the beta-lactam family (the same family as penicillins), and clavulanic acid, which is a ‘beta-lactamase inhibitor'.
Danish: Augmentin, der også er kendt som "coamoxiclav", indeholder to aktive stoffer: amoxicillin, som er et antibiotikum, der tilhører beta-lactamgruppen (samme gruppe som penicilliner), og clavulansyre, som er en beta-lactamasehæmmer.
English: • infections of the urinary tract (the structures that carry urine in the body);
Danish: • infektioner i urinvejene (de strukturer i kroppen, som leder urinen);
English: The Committee also agreed that the formulations of Augmentin that are made available in each EU country must be tailored to the types of bacteria that are ‘prevalent' in the country, especially their ability to resist the action of certain antibiotics.
Danish: Udvalget besluttede ligeledes, at de formuleringer af Augmentin, som markedsføres i de enkelte EUlande, skal være specifikt tilpasset til de bakterietyper, der er fremherskende i det pågældende land, navnlig når det gælder deres resistens over for visse antibiotika.
English: The Committee agreed that the tablets and oral suspensions containing amoxicillin and clavulanic acid as a 2:1 ratio should not be used in lower respiratory tract infections or in otitis media.
Danish: Udvalget besluttede, at tabletter og oral suspension, som indeholder amoxicillin og clavulansyre i forholdet 2:1, ikke bør anvendes ved infektioner i de nedre luftveje eller otitis media.
English: The indications (the diseases the medicine can be used to treat) for the tablets and oral suspensions depend on the ratio of the active substances and have been harmonised to include: acute bacterial sinusitis (adequately diagnosed), acute otitis media, lower respiratory tract infections (such as acute exacerbations of chronic bronchitis and community acquired pneumonia), cystitis, pyelonephritis, and skin and soft tissue infections in particular cellulites, animal bites, severe dental abscess with spreading cellulitis, and bone and joint infections.
Danish: Indikationerne (de sygdomme, som lægemidlet kan anvendes til at behandle) for tabletter og oral suspension afhænger af forholdet mellem de aktive stoffer og er blevet harmoniseret, så de omfatter: akut bakteriel sinusitis (korrekt diagnosticeret), akut otitis media, infektioner i de nedre luftveje (såsom akut forværring af kronisk bronkitis og samfundserhvervet pneumoni), cystitis, pyelonefritis, hud- og bløddelsinfektioner, navnlig cellulitis, dyrebid, alvorlig dental absces med udbredelse af cellulitis samt knogle- og ledinfektioner.
English: Posology and method of administration
Danish: Dosering og indgivelsesmåde
English: The Committee harmonised the contra-indications for Augmentin to two contra-indications: in case of hypersensitivity to penicillins, or allergic reaction to other beta-lactam antibiotics, and in case of jaundice or liver problems previously caused by amoxicillin/clavulanic acid.
Danish: Udvalget harmoniserede kontraindikationerne for Augmentin til to kontraindikationer, nemlig i tilfælde af overfølsomhed over for penicilliner eller allergisk reaktion over for andre betalactamantibiotika og i tilfælde af gulsot eller leverproblemer, der tidligere er udløst af amoxicillin/clavulansyre.
English: Tablets containing amoxicillin and clavulanic acid as a 16:1 ratio should only be used for the treatment of community-acquired pneumonia that is likely to have been caused by penicillin-resistant Streptococcus pneumoniae.
Danish: Tabletter, som indeholder amoxicillin og clavulansyre i forholdet 16:1, bør kun bruges til behandling af samfundserhvervet pneumoni, der sandsynligvis er forårsaget af penicillinresistent Streptococcus pneumoniae.
English: The CHMP harmonised the indications for Augmentin used as an intravenous injection (into a vein) to include certain diseases for which oral treatment is not appropriate: severe infections of the ear, nose and throat, intra-abdominal infections and female genital infections.
Danish: CHMP harmoniserede indikationerne for Augmentin anvendt som intravenøs injektion (injektion i en vene) med henblik på at medtage visse sygdomme, hvor oral behandling ikke er hensigtsmæssig, nemlig alvorlige øre-, næse- og halsinfektioner, intraabdominale infektioner og infektioner i de kvindelige kønsorganer.
English: Co-Rapporteur:
Danish: Rapportør: Medrapportør:
English: The Committee also restricted the use of oral suspensions containing amoxicillin and clavulanic acid as a 14:1 ratio to the treatment of children with acute otitis media and community acquired pneumonia likely to have been caused by penicillin-resistant Streptococcus pneumoniae.
Danish: Udvalget begrænsede også brugen af oral suspension, som indeholder amoxicillin og clavulansyre i forholdet 14:1, til behandling af børn med akut otitis media og samfundserhvervet pneumoni, der sandsynligvis er forårsaget af penicillinresistent Streptococcus pneumoniae.
English: The CHMP also agreed that the injection can be used to prevent infections in major surgeries involving the gut, pelvic cavity, head and neck and the biliary tract.
Danish: CHMP besluttede ligeledes, at injektion kan anvendes til at forebygge infektioner ved større operationer i tarme, bækkenhule, hoved, hals og galdeveje.
English: Augmentin is available as tablets, oral suspensions and solutions for injections or infusion (drip into vein).
Danish: Augmentin fås som tabletter, oral suspension og injektionsvæske, opløsning, eller infusionsvæske, opløsning (drop i en vene).
English: The Committee harmonised the text of the posology section of the SPC to highlight to prescribers the need to check the appropriateness of the amoxicillin:clavulanic acid ratio to use, looking in particular at the type of bacteria that may be causing infections, the severity and site of infection, and the age, weight and kidney function of the patients.
Danish: Udvalget harmoniserede teksten i produktresuméets punkt om dosering for at gøre de ordinerende læger opmærksomme på, at det er nødvendigt at tjekke egnetheden af det amoxicillin/clavulansyreforhold, der skal anvendes, navnlig i betragtning af den bakterietype, der sandsynligvis forårsager infektionen, infektionens sværhedsgrad og sted samt patientens alder, vægt og nyrefunktion.
English: EMA/242206/2013 EMEA/H/C/002425
Danish: Den 25. april 2013 EMA/242206/2013 EMEA/H/C/002425
English: It was to be available as 150 mg tablets.
Danish: Det var hensigten, at det skulle leveres som 150 mg tabletter.
English: What is Raxone?
Danish: Hvad er Raxone?
English: However, the CHMP concluded that the new subgroup of patients proposed for treatment was not well represented in the study (28 patients) and the reliability of the results is questionable.
Danish: CHMP konkluderede imidlertid, at den nye undergruppe af patienter, der blev foreslået behandlet, ikke var velrepræsenteret i undersøgelsen (28 patienter), og at pålideligheden af resultaterne er tvivlsom.
English: The CHMP did not consider this benefit to be significant.
Danish: CHMP anså ikke denne fordel for at være væsentlig.
English: The effects of Raxone were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Raxone blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In its letter notifying the Agency of the withdrawal of application, the company state that it was withdrawing the application for strategic reasons.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes strategiske årsager.
English: Patients affected by LHON have mutations (defects) in the genetic material of mitochondria.
Danish: Patienter med LHON har mutationer (defekter) i mitokondriernes genetiske materiale.
English: Withdrawal of the marketing authorisation application for Raxone (idebenone)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Raxone (idebenon)
English: These patients showed an improvement of 17 letters on the letter chart compared with placebo.
Danish: Disse patienter viste en bedring på 17 bogstaver på synstavlen i forhold til placebobehandling.
English: What was Raxone expected to be used for?
Danish: Hvad forventedes Raxone anvendt til?
English: Raxone is a medicine that contains the active substance idebenone.
Danish: Raxone er et lægemiddel, der indeholder det aktive stof idebenon.
English: Patients in compassionate use programmes can continue using Raxone.
Danish: Patienter i programmer med særlig udleveringstilladelse kan fortsætte med at bruge Raxone.
English: In the study, patients received Raxone or placebo (a dummy treatment) for six months.
Danish: I undersøgelsen fik patienterne enten Raxone eller placebo (virkningsløs behandling) i seks måneder.
English: How is Raxone expected to work?
Danish: Hvordan forventes Raxone at virke?
English: At the time of the negative opinion, the CHMP was concerned that in patients with LHON whose symptoms started in the previous five years, taking Raxone for six months did not lead to a significant improvement in vision compared with placebo (patients taking Raxone were able to distinguish three more letters on the letter chart compared with patients taking placebo).
Danish: På tidspunktet for den negative udtalelse var der i CHMP betænkelighed ved, at patienter med LHON, hvis sygdom var begyndt i de foregående fem år, og som havde taget Raxone i seks måneder, ikke havde fået væsentligt bedre syn sammenlignet med placebobehandling (de patienter, der fik Raxone, kunne læse tre bogstaver mere på synstavlen end de, der fik placebo).
English: The company had requested a re-examination of the negative opinion, but withdrew before this re-examination had started.
Danish: Virksomheden havde anmodet om en revurdering af den negative udtalelse, men denne revurdering var endnu ikke afsluttet, da virksomheden trak sin ansøgning tilbage.
English: Given the small size of this sub-group, the CHMP considered that a spontaneous improvement could not be ruled out.
Danish: På baggrund af den lille størrelse af denne undergruppe fandt CHMP, at det ikke kunne udelukkes, at bedringen var spontan.
English: The main measure of effectiveness was the change in vision after six months of treatment measured using a standard eye test with a letter chart.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i synet efter seks måneders behandling, målt ved hjælp af en almindelig synstavle.
English: On 21 March 2013, Santhera Pharmaceuticals (Deutschland) GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raxone, for the treatment of Leber's hereditary optic neuropathy (LHON).
Danish: Den 21. marts 2013 meddelte Santhera Pharmaceuticals (Deutschland) GmbH officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Raxone til behandling af Lebers hereditære opticus-neuropati (LHON).
English: In addition, the CHMP considered that the data supporting the mode of action for idebenone in LHON are not sufficient.
Danish: Desuden fandt CHMP, at dataene til underbygning af virkningen af idebenon ved LHON ikke er tilstrækkelige.
English: The company presented the results from one main study with Raxone involving 85 patients with LHON whose symptoms started in the previous five years.
Danish: Virksomheden fremlagde resultaterne af én hovedundersøgelse med Raxone, hvori der deltog 85 patienter med LHON, hvis symptomer var begyndt inden for de foregående fem år.
English: Based on the same study, the company later proposed to restrict the use of Raxone to patients with LHON whose symptoms started in the previous year.
Danish: På grundlag af den samme undersøgelse foreslog virksomheden senere at begrænse anvendelsen af Raxone til LHON-patienter, hvis symptomer var begyndt inden for det foregående år.
English: Raxone was expected to be used for the treatment of LHON, which is an inherited disease characterised by progressive loss of sight.
Danish: Raxone forventedes anvendt til behandling af LHON, en arvelig sygdom, der medfører gradvist synstab.
English: The way idebenone works in LHON is not fully understood but it is thought to reduce the formation of free radicals and to help improve production of energy, thereby preventing the cellular damage and the loss of sight seen in LHON.
Danish: Det vides ikke fuldstændig, hvordan idebenon virker ved LHON, men det menes at nedsætte dannelsen af frie radikaler og bidrage til at forbedre energiproduktionen, så cellebeskadigelsen og synstabet ved LHON mindskes.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Raxone did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Raxone ikke var tilfredsstillende påvist og ikke er større end risiciene.
English: The active substance in Raxone, idebenone, acts on structures inside cells known as mitochondria, which produce the energy necessary for cells to function.
Danish: Det aktive stof i Raxone, idebenon, virker på mitokondrierne, som er de indvendige strukturer i cellerne, der producerer den energi, cellerne behøver for at fungere.
English: This means that mitochondria do not work properly to generate energy, and produce toxic forms of oxygen (free radicals) that damage nerve cells in the eye that are needed for vision.
Danish: Derfor fungerer mitokondriernes energiproduktion ikke som den skal, og den producerer giftige former for ilt (frie radikaler), som beskadiger de nerveceller i øjnene, der er nødvendige for synet.
English: The company informed the CHMP that there are no ongoing clinical trials.
Danish: Virksomheden har til CHMP oplyst, at der ikke pågår kliniske undersøgelser med Raxone.
English: Raxone was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 15 February 2007 for the treatment of LHON.
Danish: Raxone blev den 15. februar 2007 udpeget som "lægemiddel til sjældne sygdomme" til behandling af LHON.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion recommending that the marketing authorisation be refused for Raxone for the treatment of Leber's hereditary optic neuropathy (LHON).
Danish: Efter at have gennemgået dataene havde CHMP afgivet en negativ udtalelse og anbefalet afslag på udstedelse af markedsføringstilladelse for Raxone til behandling af Lebers hereditære opticus-neuropati (LHON).
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Raxone eller i programmer for anvendelse af Raxone med særlig udleveringstilladelse?
English: Consider initial dose of 1 mg/kg/day to 4 mg/kg/day prednisone or equivalent followed by taper
Danish: Overvej initial dosis på 1 mg/kg/dag til 4 mg/kg/dag prednison eller tilsvarende, efterfulgt af nedtrapning
English: Patients should be monitored for signs and symptoms and managed as recommended in section 4.2.
Danish: Patienterne bør monitoreres for tegn og symptomer og behandles som anbefalet i pkt.
English: The following immune-related adverse reactions were reported in less than 1% of patients
Danish: Følgende immunmedierede bivirkninger blev rapporteret hos mindre end 1 % af de
English: Your doctor may delay the next dose of IMFINZI or stop your treatment with IMFINZI, if you have:
Danish: Din læge kan udskyde den næste dosis af IMFINZI eller standse din behandling med IMFINZI, hvis du har:
English: Adopted at the 30 September-3 October 2019 PRAC
Danish: Vedtaget på PRAC's møde den 30. september - 3. oktober 2019
English: Corticosteroid treatment unless otherwise specified
Danish: Kortikosteroidbehandling, medmindre andet er angivet
English: Given the mechanism of action of IMFINZI, other potential immune-mediated adverse reactions may occur.
Danish: I betragtning af IMFINZI's virkningsmekanisme kan andre potentielle immunmedierede bivirkninger forekomme.
English: Withhold dose
Danish: Tilbagehold dosis
English: Durvalumab - Myasthenia gravis (EPITT no 19451)
Danish: Durvalumab - Myasthenia gravis (EPITT nr. 19451)
English: • Inflammation or problems of the muscles: symptoms may include muscle pain, or weakness or rapid fatigue of the muscles;
Danish: • Betændelse i eller problemer med musklerne: Symptomerne kan omfatte muskelsmerter eller svaghed eller hurtig muskeltræthed;
English: treated with IMFINZI monotherapy in clinical trials (n = 1889): myasthenia gravis, myocarditis, myositis, polymyositis.
Danish: patienter, der blev behandlet med IMFINZI monoterapi i kliniske forsøg (n = 1889): myasthenia gravis, myokarditis, myositis, polymyositis.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/532016/2019
Danish: Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/556434/2019
English: Rare: a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Danish: Sjælden: en tilstand, hvor musklerne bliver svage, og hvor de hurtigt bliver trætte (myasthenia gravis).
English: Undesirable effects Nervous system disorders Rare: Myasthenia gravis
Danish: Bivirkninger Nervesystemet Sjælden: Myasthenia gravis
English: Permanently discontinue d d) For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Danish: Permanent seponeringd d) Ved myasthenia gravis skal IMFINZI seponeres permanent, hvis der er tegn på muskelsvaghed eller respiratorisk insufficiens.
English: IMFINZI treatment modification
Danish: Sværhedsgrada Behandlingsmodifikation for IMFINZI
English: Summary of product characteristics 4.2.
Danish: Produktresumé 4.2.
English: Frequency not known: eruption of the skin or mucous membranes (lichenoid drug reaction)
Danish: Hyppighed ikke kendt: udslæt på huden eller slimhinderne (lichenoid lægemiddelreaktion)
English: Other immunemediated adverse reactions
Danish: Andre immunmedierede bivirkninger
English: Lithium - Drug-induced lichenoid reaction (EPITT no
Danish: Lithium - Lægemiddelinduceret lichenoid reaktion (EPITT nr. 19389)
English: Special warnings and precautions for use
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Andre immunmedierede bivirkninger
English: Posology and method of administration Adverse reactions Severity a
Danish: Dosering og administration Bivirkninger
English: The binding is about 90%.
Danish: Bindingen er cirka 90 %.
English: Macrogol (3350)
Danish: Makrogol (3350)
English: ATC code: H02AB09.
Danish: ATC-kode: H02AB09.
English: The lowest possible maintenance dosage should be used.
Danish: Den lavest mulige vedligeholdelsesdosis bør anvendes.
English: B - 1000 Brussels Belgium
Danish: B - 1000 Bruxelles Belgien
English: Risks may be higher when high doses are given.
Danish: Risikoen kan være højere, når der gives høje doser.
English: No antidote is available.
Danish: Der er ingen tilgængelig antidot.
English: Plenadren with food and drink
Danish: Brug af Plenadren sammen med mad og drikke
English: A too high dose of this medicine for more than a few days may be harmful to your health.
Danish: En for høj dosis af lægemidlet i mere end nogle få dage kan være skadelig for helbredet.
English: Side effects of this medicine are:
Danish: Bivirkninger fra lægemidlet er:
English: Frequencies of these possible side effects are not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden af disse mulige bivirkninger er ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: In addition they modify the body's immune responses to diverse stimuli.
Danish: Desuden modificerer de kroppens immunrespons til diverse stimuli.