FrancophonIA/ELRC3.0 huggingface dataset:
English: Fipronil 24.9 mg; (S)-methoprene 30 mg; eprinomectin 1.2 mg; praziquantel 24.9 mg Fipronil 74.7 mg; (S)-methoprene 90 mg; eprinomectin 3.6 mg; praziquantel 74.7 mg
Danish: -1 Fipronil 24,9 mg; (S)-methopren 30 mg; eprinomektin 1,2 mg; praziqvantel 24,9 mg -2 Fipronil 74,7 mg; (S)-methopren 90 mg; eprinomektin 3,6 mg; praziqvantel 74,7 mg
English: (EU) MA Number Invented name
Danish: EU-nummer
English: The doctor should review treatment regularly, at least every 6 months, and only continue treatment if the patient is benefits from it.
Danish: Lægen bør gennemgå behandlingen regelmæssigt, mindst hver 6. måned, og kun lade behandlingen fortsætte, hvis patienten har gavn af den.
English: The dose can be increased up to a maximum of 10 mg if the medicine is not working well enough.
Danish: Dosen kan øges til højst 10 mg, hvis lægemidlet ikke virker godt nok.
English: Further information on Slenyto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Slenyto findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine contains the active substance melatonin.
Danish: Lægemidlet indeholder det aktive stof melatonin.
English: As for all medicines, data on the use of Slenyto are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Slenyto løbende overvåget.
English: The normal dose is 2 mg taken 30 minutes to one hour before bedtime.
Danish: Den normale dosis er 2 mg, der tages 30 minutter til 1 time før sengetid.
English: Slenyto is available as tablets (1 and 5 mg).
Danish: Slenyto fås som tabletter (1 mg og 5 mg).
English: What measures are being taken to ensure the safe and effective use of Slenyto?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Slenyto?
English: The side effects seen with the medicine over 2 years appear mild or moderate but more data are needed on longer term safety.
Danish: Vurderet over en periode på 2 år synes bivirkningerne ved lægemidlet at være milde til moderate af sværhedsgrad, men der er behov for yderligere data for sikkerheden på længere sigt.
English: • autism spectrum disorder (ASD), a range of conditions that affects the patient's social interactions;
Danish: • autismespektrumforstyrrelse (ASD), der er en række sygdomme, som påvirker patientens sociale relationer
English: Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night.
Danish: Indholdet af stoffet i blodet stiger normalt, når mørket falder på, og topper midt om natten.
English: For more information about using Slenyto, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Slenyto, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: • Smith-Magenis syndrome, a condition that can lead to learning difficulties.
Danish: • Smith-Magenis syndrom, der er en sygdom, som kan medføre indlæringsvanskeligheder.
English: The most common side effects with Slenyto (which may affect up to 1 in 10 people) are sleepiness, tiredness, mood swings, headache, irritability, aggression and feeling hungover.
Danish: De hyppigste bivirkninger ved Slenyto (der kan forekomme hos op til 1 ud af 10 patienter) er søvnighed, træthed, humørsvingninger, hovedpine, irritabilitet, aggression og tømmermænd.
English: Other information about Slenyto
Danish: Andre oplysninger om Slenyto
English: Side effects reported with Slenyto are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Slenyto vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency decided that Slenyto's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Slenyto opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Melatonin is involved in coordinating the body's sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep.
Danish: Melatonin medvirker ved koordinering af kroppens søvncyklus gennem påvirkning af celler i specifikke områder af hjernen og hjælper patienterne med at falde i søvn.
English: An overview of Slenyto and why it is authorised in the EU
Danish: En oversigt over Slenyto, og hvorfor det er godkendt i EU
English: All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work.
Danish: Alle patienter havde tidligere prøvet andre foranstaltninger som f.eks. regelmæssige soverutiner, men uden virkning.
English: Patients with developmental conditions may produce less melatonin, leading to the development of insomnia.
Danish: Patienter med udviklingsmæssige forstyrrelser kan danne en mindre mængde melatonin, hvilket medfører udvikling af søvnløshed.
English: What are the risks associated with Slenyto?
Danish: Hvilke risici er der forbundet med Slenyto?
English: Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.
Danish: Da Slenyto frigiver melatonin langsomt over nogle timer, efterligner det kroppens naturlige produktion af melatonin.
English: In addition, children who took Slenyto fell asleep around 38 minutes earlier than normal while those taking placebo fell asleep 13 minutes earlier.
Danish: Desuden faldt de børn, der fik Slenyto, i søvn 38 minutter tidligere end normalt, mens de børn, der fik placebo, faldt i søvn 13 minutter tidligere.
English: Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:
Danish: Slenyto er et lægemiddel til behandling af søvnløshed hos børn og unge i alderen 2-18 år, som har:
English: The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.
Danish: Andelen af børn med neurologiske sygdomme som f.eks. autismespektrumforstyrrelse og SmithMagenis syndrom, der også lider af søvnløshed, er høj, og der findes ikke mange behandlinger.
English: The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland.
Danish: Det aktive stof i Slenyto, melatonin, er et naturligt hormon, der normalt produceres af en kirtel i hjernen, der hedder koglekirtlen.
English: Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.
Danish: Slenyto anvendes, når andre foranstaltninger som f.eks. regelmæssige soverutiner ikke har virket.
English: Why is Slenyto authorised in the EU?
Danish: Hvorfor er Slenyto godkendt i EU?
English: Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome.
Danish: Det er påvist, at Slenyto er effektivt til at forbedre søvn hos børn og unge med neurologiske sygdomme, herunder autismespektrumforstyrrelse og Smith-Magenis-syndrom.
English: Slenyto increases levels of melatonin in the blood, helping them to sleep.
Danish: Slenyto øger koncentrationen af melatonin i blodet, og det hjælper patienterne med at falde i søvn.
English: Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo.
Danish: Det er påvist, at Slenyto forbedrer søvnen hos disse patienter, idet patienter, der tager Slenyto, sover i 51 minutter længere pr. nat sammenholdt med 19 minutter længere ved placebo.
English: How is Slenyto used?
Danish: Hvordan anvendes Slenyto?
English: In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment).
Danish: I et hovedstudie med 125 patienter sov de patienter, der fik Slenyto i 13 uger, i gennemsnit 51 minutter længere pr. nat, mens de patienter, der fik placebo (ikke-aktivt stof), sov 19 minutter længere.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Slenyto have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Slenyto.
English: What is Slenyto and what is it used for?
Danish: Hvad er Slenyto, og hvad anvendes det til?
English: What benefits of Slenyto have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Slenyto?
English: How does Slenyto work?
Danish: Hvordan virker Slenyto?
English: 16 December 2014 EMA/785229/2014 corr1
Danish: Den 16. december 2014 EMA/785229/2014
English: Currently, products containing colistimethate sodium for use by injection or by inhalation as a solution or as a mist (nebulised) are approved under various trade names in Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands Poland, Portugal, Romania, Slovakia, Spain, Sweden and United Kingdom.
Danish: Produkter indeholdende colistimethatnatrium til injektion eller inhalation som opløsning eller aerosol er godkendt under forskellige handelsnavne i Østrig, Belgien, Bulgarien, Kroatien, Tjekkiet, Danmark, Estland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Spanien, Sverige og Det Forenede Kongerige.
English: The review of polymyxin-based medicines was initiated on 16 September 2013 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af polymyxinbaserede lægemidler blev indledt den 16. september 2013 på anmodning af Europa-Kommissionen i medfør af artikel 31 i direktiv 2001/83/EF.
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision valid throughout the EU on 16 December 2014.
Danish: CHMP's udtalelse blev forelagt Europa-Kommissionen, som den 16. december 2014 traf en endelig afgørelse med gyldighed i hele EU.
English: • Patients who have any questions about their treatment should consult their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål til deres behandling, bør kontakte lægen eller apotekspersonalet.
English: • Dosage should be in line with relevant treatment guidelines.
Danish: • Doseringen bør svare til relevante behandlingsvejledninger.
English: However, it was considered that in the interim the product information should be updated throughout the EU to reflect what was currently known.
Danish: Det blev imidlertid anset for nødvendigt i mellemtiden at ajourføre produktinformationen i hele EU, så den afspejler den nuværende viden.
English: European Medicines Agency completes review of polymyxin-based medicines
Danish: Det Europæiske Lægemiddelagentur har gennemgået polymyxinbaserede lægemidler
English: (Products for inhalation as a dry powder have a different dosage and distribution in the body, and were not affected by the conclusions of the review.)
Danish: (Produkter til inhalation som tørt pulver har en anderledes dosering og fordeling i kroppen og var ikke omfattet af konklusionerne af gennemgangen).
English: Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects.
Danish: Polymyxinbaserede lægemidler har været på markedet siden 1960'erne, men deres anvendelse faldt hurtigt, da der fandtes antibiotika med færre potentielle bivirkninger.
English: 1 Nominal potency of the drug substance = 12.500 IU/mg
Danish: 1 Lægemiddelstoffets nominelle styrke = 12 500 IE/mg.
English: The European Commission therefore requested the EMA to review the available data and make recommendations on whether the marketing authorisations for these medicines should be changed and the product information amended appropriately.
Danish: Europa-Kommissionen anmodede derfor EMA om at gennemgå de foreliggende data og fremsætte anbefalinger for, hvorvidt markedsføringstilladelserne for disse lægemidler burde ændres og tilsvarende ændringer foretages i produktinformationen.
English: Colistin-base activity (CBA) (mg)1
Danish: Colistinbase-aktivitet (CBA) (mg)1
English: The medicine should be given with another suitable antibiotic where possible.
Danish: Lægemidlet bør om muligt gives sammen med et andet velegnet antibiotikum.
English: • The available information on colistimethate sodium has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Danish: • Der er foretaget en gennemgang af de foreliggende oplysninger om colistimethatnatrium, og der er fremsat anbefalinger om sikker brug og passende dosering.
English: Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly.
Danish: Til kritisk syge patienter bør der anvendes en højere startdosis (støddosis) for hurtigere at opnå en effektiv koncentration af antibiotikummet.
English: • Intravenous colistimethate sodium does not cross the blood-brain barrier to a significant extent.
Danish: • Intravenøst colistimethatnatrium passerer ikke blod-hjernebarrieren i nævneværdigt omfang.
English: The review of these data was conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which considered them and formulated the Agency's final opinion.
Danish: Gennemgangen af disse data blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: This has led to a resurgence in recent years in the use of polymyxins in patients with few other options.
Danish: I de senere år har dette ført til en fornyet stigning i brugen af polymyxiner hos patienter, som kun har få andre behandlingsmuligheder.
English: • The product information for medicines containing colistimethate sodium will be updated as required to take these recommendations into account.
Danish: • Produktoplysningerne for lægemidler indeholdende colistimethatnatrium vil blive ajourført i overensstemmelse med disse anbefalinger.
English: The Agency's recommendations are based on a review of the available clinical, pharmacological and pharmacokinetic data, although significant gaps still exist, particularly with regard to the pharmacokinetics in special populations such as children and patients with renal impairment.
Danish: Agenturets anbefalinger bygger på en gennemgang af de foreliggende kliniske, farmakologiske og farmakokinetiske data, men der er betydelige datamangler, navnlig i farmakokinetikken hos særlige populationer såsom børn og patienter med nedsat nyrefunktion.
English: Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
Danish: Skønt der kun forelå meget begrænsede data, fremsatte udvalget dosisanbefalinger for patienter med nyreproblemer og for børn samt vejledning om doseringen hos voksne ved direkte indgift i den væske, der omgiver hjernen eller rygmarven (intratekal eller intraventrikulær injektion).
English: • In children, the suggested dose is 75,000 to 150,000 IU/kg daily, in 3 divided doses.
Danish: • Hos børn er den anbefalede dosis 75 000 til 150 000 IE/kg dagligt, fordelt på 3 doser.
English: The recommended dose in adults is 1 to 2 million IU given 2 to 3 times a day, and in children 0.5 to 1 million IU twice daily, adjusted according to the severity of the condition and the response.
Danish: Den anbefalede dosis til voksne er 1-2 millioner IE dagligt fordelt på 2-3 doser, og til børn 0,5-1 millioner IE to gange dagligt, tilpasset efter sygdommens sværhed og patientens respons.
English: Recommendations issued for safe use in patients with serious infections resistant to standard antibiotics
Danish: Agenturet har fremsat anbefalinger for sikker anvendelse hos patienter med alvorlige infektioner, der er resistente mod sædvanlige antibiotika
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) gennemgik de foreliggende data om disse lægemidlers farmakokinetik, virkning og sikkerhed.
English: In addition, colistimethate sodium has been approved in the EU for inhalation as a dry powder under the trade name Colobreathe.
Danish: Derudover er colistimethatnatrium i EU godkendt til inhalation som tørt pulver under handelsnavnet Colobreathe.
English: • Doses should always be expressed in IU of colistimethate sodium.
Danish: • Doser bør altid angives i IE colistimethatnatrium.
English: The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information.
Danish: Udvalget anbefalede, at doserne altid angives i internationale enheder (IE), men at der indsættes en omregningstabel i produktinformationen, da dosis af colistimethatnatrium kan angives på forskellige måder.
English: Products containing colistin are available for use by mouth or for external application but are not included in this review, as they are not considered to produce significant amounts of the active substance in the body.
Danish: Produkter indeholdende colistin fås til indtagelse gennem munden eller til udvendig brug, men er ikke omfattet af denne gennemgang, da de ikke menes at frembringe nævneværdige mængder af det aktive stof i kroppen.
English: However, current experience has raised concerns that the existing product information, in particular relating to dosing and the way the medicine is handled in the body (pharmacokinetics), might need updating.
Danish: De nuværende erfaringer peger imidlertid på, at der kan være behov for at ajourføre den eksisterende produktinformation, navnlig vedrørende doseringen og hvordan lægemidlets håndteres af kroppen (farmakokinetikken).
English: Colistin and its prodrug colistimethate sodium are the only polymyxins approved for clinical use in the EU, and the review was limited to products used by injection or inhalation (all formulated as colistimethate sodium).
Danish: Colistin og dets prodrug colistimethatnatrium er de eneste polymyxiner, der er godkendt til klinisk brug i EU, og gennemgangen blev begrænset til produkter til injektion eller inhalation (alle formuleret som colistimethatnatrium).
English: Based on the limited available evidence the recommended dose in adults is 9 million IU daily in 2 or 3 divided doses as a slow intravenous infusion; in critically ill patients a loading dose of 9 million IU should be given.
Danish: På grundlag af den begrænsede foreliggende evidens er den anbefalede dosis til voksne 9 millioner IE dagligt ved langsom intravenøs infusion fordelt på to eller tre doser; til kritisk syge patienter gives en støddosis på 9 millioner IE.
English: Consideration should be given to co-administration with another antibacterial agent whenever this is possible.
Danish: Koadministration med et andet antibiotikum bør altid overvejes, når det er muligt.
English: Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
Danish: Delvis som følge af den begrænsede brug har colistimethatnatrium bevaret sin virkning mod en række bakterier, der er blevet resistente over for sædvanlige antibiotika.
English: Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
Danish: Når det er hensigtsmæssigt, anbefales til voksne en dosis på 125 000 IE intraventrikulært og højst denne dosis intratekalt.
English: A parallel review under Article 5(3) of Regulation (EC) No 726/2004 is currently also under way, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Danish: I henhold til artikel 5, stk. 3, i forordning (EF) nr. 726/2004 foregår der en sideløbende gennemgang, der ser nærmere på præparaternes kvalitet og den anvendte metode til måling og testning af colistimethatnatriums styrke.
English: Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Danish: Colistimethatnatrium gives ved injektion eller inhalation og omdannes i kroppen til colistin.
English: Colistimethate sodium (mg)
Danish: Colistimethatnatrium (mg)
English: Doses should be reduced according to creatinine clearance in patients with renal impairment.
Danish: Hos patienter med nyrefunktionsnedsættelse bør dosis nedsættes i henhold til kreatininclearance.
English: Colistimethate sodium (IU)
Danish: Colistimethatnatrium (IE)
English: The review considered products given by injection or inhaled as a liquid into the lungs (systemic use) containing colistimethate sodium, which is converted to the active substance colistin in the body.
Danish: Gennemgangen omfattede produkter, der gives ved injektion eller inhalation i væskeform (systemisk anvendelse), og som indeholder colistimethatnatrium, der i kroppen omdannes til det aktive stof colistin.
English: • Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
Danish: • Injektion eller infusion (drop) af colistimethatnatrium bør kun anvendes ved alvorlige infektioner, hvor der er få andre behandlingsmuligheder, og normalt i kombination med et andet antibiotikum.
English: To address the differences in the way in which the strength of colistimethate sodium and colistin are expressed in the EU and in other regions such as the USA and Australia, which has led to errors in reporting in the medical literature and could potentially lead to serious medication errors, the following table will be included in the product information:
Danish: I produktinformationen indsættes følgende tabel for at imødegå forskellene i styrkeangivelse for colistimethatnatrium og colistin mellem EU og andre regioner såsom USA og Australien, da dette har givet anledning til ukorrekte angivelser i den medicinske litteratur og kan tænkes at medføre alvorlige medicineringsfejl:
English: • Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
Danish: • Colistin og colistimethatnatrium er ældre antibiotika i klassen polymyxiner, der undertiden bruges mod infektioner, som er resistente mod nyere lægemidler.
English: • Intravenous colistimethate sodium is indicated in adults and children including neonates for the treatment of serious infections due to aerobic Gram-negative pathogens in patients with limited treatment options.
Danish: • Intravenøst colistimethatnatrium er indiceret hos voksne og børn, herunder nyfødte, til behandling af alvorlige infektioner forårsaget af aerobe gramnegative patogener hos patienter med få andre behandlingsmuligheder.