FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported side effects were symptoms affecting the gut (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), all occurring in less than 2.5% of patients.
Danish: De hyppigst indberettede bivirkninger var gastrointestinale symptomer (diarré, forstoppelse, kvalme og opkastning), hovedpine, svimmelhed og hypotension, som alle forekom hos mindre end 2,5 % af patienterne.
English: It is available as a solution for infusion (drip) into a vein.
Danish: Det leveres som en infusionsvæske (drop i en vene).
English: In addition, the company that market Rienso will provide educational material to patients and doctors expected to use Rienso, with information on the risk of allergic reactions.
Danish: Virksomheden, der markedsfører Rienso, vil desuden udlevere informationsmateriale til patienter og læger, som forventes at anvende Rienso, om risikoen for allergiske reaktioner.
English: The increase in haemoglobin seen in the main studies was considered by the CHMP to be a valuable improvement and comparable to what is obtained with standard intravenous iron preparations.
Danish: CHMP anså stigningen i hæmoglobinindholdet i hovedundersøgelsen for at være en betydelig forbedring og sammenlignelig med resultaterne af behandling med almindelige intravenøse jernpræparater.
English: It must not be used in patients with evidence of excess iron in the body or in patients whose anaemia is not caused by iron deficiency.
Danish: Det må ikke anvendes til patienter med tegn på jernoverskud i kroppen eller til patienter, hvis anæmi ikke skyldes jernmangel.
English: The CHMP decided that Rienso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Rienso opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Rienso.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rienso, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Rienso, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Three main studies involving 838 chronic kidney disease patients with iron deficiency anaemia have been carried out to compare Rienso with an iron treatment taken by mouth.
Danish: Der blev gennemført tre hovedundersøgelser af 838 patienter med kronisk nyresygdom og jernmangelanæmi for at sammenligne behandlingen med Rienso med oral jernbehandling.
English: To maintain normal haemoglobin levels, patients may be re-treated with Rienso if they are confirmed to be lacking iron.
Danish: For at opretholde et normalt hæmoglobinindhold kan det være nødvendigt at genbehandle patienter med Rienso, hvis det viser sig, at de stadig mangler jern.
English: Rienso should only be given when healthcare professionals trained to manage anaphylactic (severe allergic) reactions and full resuscitation facilities are available.
Danish: Rienso bør kun gives, når der er sundhedspersonale tilstede, som er uddannet i håndtering af anafylaktiske (svære allergiske) reaktioner, og når der er genoplivningsudstyr til rådighed.
English: The active substance in Rienso, ferumoxytol, is an iron-containing compound.
Danish: Det aktive stof i Rienso, ferumoxytol, er en jernholdig forbindelse.
English: Rienso is an iron preparation that contains the active substance ferumoxytol.
Danish: Rienso er et jernpræparat, som indeholder det aktive stof ferumoxytol.
English: Rienso must not be used in people with a history of drug allergy, including allergy to ferumoxytol or any other iron preparation.
Danish: Rienso må ikke anvendes til patienter med tidligere lægemiddelallergi, herunder allergi over for ferumoxytol eller noget andet jernpræparat.
English: Rienso was more effective at increasing haemoglobin levels than the iron treatment taken by mouth.
Danish: Rienso var mere effektivt til at øge hæmoglobinniveauet end den orale jernbehandling.
English: When injected into the blood, it is taken up by cells in the liver, spleen and the bone marrow, at which point the iron is released from the compound and replaces the body's depleted iron stores.
Danish: Når det injiceres i blodet, optages det af celler i leveren, milten og knoglemarven, hvor jernet frigives og fylder kroppens tomme jernlagre op. Med genopfyldte jernlagre kan kroppen producere mere hæmoglobin, som vil medvirke til at korrigere anæmien.
English: Iron deficiency is a common cause of anaemia in patients with long-term kidney disease and is itself caused by many factors including the poor absorption of dietary iron from food.
Danish: Jernmangel er en almindelig årsag til anæmi hos patienter med kronisk nyresygdom, og den kan skyldes mange faktorer som f.eks. ringe optagelse af jern fra kosten.
English: What is the risk associated with Rienso?
Danish: Hvilken risiko er der forbundet med Rienso?
English: Rienso is used to treat anaemia (low levels of red blood cells or haemoglobin) caused by a deficiency of iron in patients with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Danish: Rienso anvendes til behandling af anæmi (mangel på røde blodlegemer eller hæmoglobin), som skyldes jernmangel, hos patienter med kronisk nyresygdom (langvarig, fremadskridende nedsættelse af nyrefunktionen).
English: Why has Rienso been approved?
Danish: Hvorfor blev Rienso godkendt?
English: Rienso was shown to be superior to iron taken by mouth in treating iron deficiency anaemia in patients with chronic kidney disease.
Danish: Rienso viste sig at være bedre end oralt taget jern til behandling af jernmangelanæmi hos patienter med kronisk nyresygdom.
English: For the full list of all side effects reported with Rienso, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Rienso fremgår af indlægssedlen.
English: What is Rienso?
Danish: Hvad er Rienso?
English: What benefit has Rienso shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rienso?
English: How has Rienso been studied?
Danish: Hvordan blev Rienso undersøgt?
English: What is Rienso used for?
Danish: Hvad anvendes Rienso til?
English: How is Rienso used?
Danish: Hvordan anvendes Rienso?
English: How does Rienso work?
Danish: Hvordan virker Rienso?
English: 26 March 2010
Danish: 26 marts 2010
English: The final opinion was converted into a Decision by the European Commission on 26 March 2010.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 26 marts
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was France and the Concerned Member States were Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and United Kingdom.
Danish: Ansøgningen blev indgivet i henhold til artikel 32 i direktiv 2001/82/EF, hvor referencemedlemsstaten var Frankrig og de berørte medlemsstater var Østrig, Belgien, Bulgarien, Cypern, Den Tjekkiske Republik, Danmark, Estland, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Spanien og Det Forenede Kongerige.
English: The Decentralised Procedure FR/V/195/01/DC started on 29 February 2008.
Danish: Den decentrale procedure FR/V/195/01/DC blev indledt den 29. februar 2008.
English: The Rapporteur and Co-Rapporteur appointed were: Dr A. Holm and Dr B. Kolar, respectively.
Danish: Den udpegede rapportør og medrapportør var: Henholdsvis dr. A. Holm og dr. B. Kolar.
English: Oral explanations were given on 8 December 2009.
Danish: Der blev afgivet mundtlige redegørelser den 8. december 2009.
English: Toltrazuril is a triazinon derivative administered orally to piglets for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora suis.
Danish: Toltrazuril er et triazinonderivat, som gives oralt til smågrise til forebyggelse af kliniske symptomer på coccidiose hos nyfødte smågrise på gårde med tidligere bekræftede tilfælde af coccidiose forårsaget af Isospora suis.
English: The referral procedure started on 12 May 2009.
Danish: Indbringelsesproceduren blev indledt den 12. maj 2009.
English: Written explanations were provided by the Applicant on 18 August 2009.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 18. august 2009.
English: On 6 May 2009 France, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Germany, Spain, Portugal, Poland and the United Kingdom, that the marketing authorisation of CEVAZURIL 50 mg/ml oral suspension for piglets may present a potential serious risk to the environment.
Danish: Den 6. maj 2009 indbragte Frankrig sagen for agenturet i henhold til artikel 33, stk. 4, i direktiv 2001/82/EC som følge af betænkeligheder rejst af Tyskland, Spanien, Portugal, Polen og Det Forenede Kongerige ved, at markedsføringstilladelsen for CEVAZURIL 50 mg/ml oral suspension til smågrise kan udgøre en potentiel alvorlig risiko for miljøet.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, on 9 December 2009 the CVMP considered that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets.
Danish: På grundlag af evalueringen af rapportørens vurdering af de aktuelt foreliggende data var den 9. december 2009 CVMP af den opfattelse, at de indsigelser, der var rejst under den decentrale procedure, ikke skulle forhindre udstedelse af en markedsføringstilladelse for CEVAZURIL 50 mg/ml oral suspension til smågrise.
English: The Applicant, Ceva Santé Animale, submitted an application for a decentralised procedure for CEVAZURIL 50 mg/ml oral suspension for piglets.
Danish: Ansøgeren, Ceva Santé Animale, indgav en ansøgning om en decentral procedure for CEVAZURIL 50 mg/ml oral suspension til smågrise.
English: referral for CEVAZURIL 50 mg/ml oral suspension for piglets
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 33, stk. 4)1, om CEVAZURIL 50 mg/ml oral suspension til smågrise
English: Readability testing has been performed at a national level.
Danish: Der er foretaget læsbarhedstest på nationalt plan.
English: On this basis, no further revisions were warranted.
Danish: Der var derfor ikke behov for yderligere ændringer.
English: Data in patients with neurosyphilis are even more limited.
Danish: Data vedrørende patienter med neurosyfilis er endnu mere begrænsede.
English: Other indications
Danish: Andre indikationer
English: Overall summary of the scientific evaluation of Rocephin and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Rocephin og relaterede navne (se bilag I)
English: It is stated that the treatment of overdose should be symptomatic.
Danish: Det angives, at behandling af overdosering bør være symptomatisk.
English: Information on absorption, distribution, metabolism and elimination has been provided.
Danish: Der er givet oplysninger om absorption, fordeling, metabolisering og udskillelse.
English: The half-life increases in the elderly, and in older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.
Danish: Halveringstiden er øget hos ældre, og hos ældre over 75 år er den gennemsnitlige eliminationshalveringstid sædvanligvis 2-3 gange så lang som hos unge voksne.
English: The elimination half-life of total ceftriaxone in adults is about 8 hours.
Danish: Eliminationshalveringstiden af totalt ceftriaxon hos voksne er ca. 8 timer.
English: Infections with impaired defence mechanisms
Danish: Infektioner ved svækkede forsvarsmekanismer
English: Syphilis including neurosyphilis
Danish: Syfilis, herunder neurosyfilis
English: It was noted that the proposal for the indication is aligned with the wording previously agreed on for similar antibiotics.
Danish: Det bemærkedes, at forslaget til indikationen er på linje med den godkendte ordlyd for tilsvarende antibiotika.
English: Special populations such as patients with renal and hepatic impairment and the paediatric population have also been included.
Danish: Særlige populationer såsom patienter med nedsat nyre- og leverfunktion og den pædiatriske population er ligeledes medtaget.
English: Acute otitis media (AOM)
Danish: Akut otitis media
English: Dose recommendations have been listed in tabular format according to dosage schedules for each indication for: Adults and children over 12 years of age (≥ 50 kg), Neonates, infants and children 15 days to 12 years of age (< 50 kg) and Neonates 0-14 days.
Danish: Dosisanbefalinger er givet i tabelform svarende til doseringsplanerne for hver indikation til voksne og børn over 12 år (≥ 50 kg), nyfødte, spædbørn og børn fra 15 dage til 12 år (< 50 kg) samt nyfødte i alderen 0-14 dage.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Rocephin and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product informations for the above-mentioned products and thus to harmonise them across the EU.
Danish: På grund af medlemsstaternes divergerende nationale afgørelser ved godkendelsen af Rocephin og relaterede navne foretog Europa-Kommissionen en officiel indbringelse for EMA i medfør af artikel 30 i direktiv 2001/83/EF med henblik på at ophæve divergenserne mellem de nationalt godkendte produktoplysninger for ovennævnte produkter og dermed harmonisere dem i EU.
English: Lyme Borreliosis
Danish: Lyme-borreliose
English: However the changes are generally small and dose reduction is not required if renal and hepatic function is satisfactory.
Danish: Normalt er ændringerne dog små, og dosisreduktion er ikke nødvendig, hvis nyre- og leverfunktionen er tilfredsstillende.
English: Rocephin is approved in 19 EU Member States with different nationally approved Summaries of Product Characteristics (SmPCs).
Danish: Rocephin er godkendt i 19 EU-medlemsstater med forskellige nationalt godkendte produktresuméer.
English: The MAH's proposal ‘Infections in patients with impaired defence mechanisms' was not considered to be sufficiently supported by data.
Danish: Markedsføringstilladelsesindehaverens forslag “infektioner hos patienter med svækkede forsvarsmekanismer” fandtes ikke tilstrækkeligt underbygget med data.
English: The amended wording was considered to be acceptable by the CHMP.
Danish: Den ændrede ordlyd blev godkendt af CHMP.
English: Based on the above, the CHMP considers the benefit/risk ratio of Rocephin and associated names to be favourable and the harmonised Product Information documents to be approvable.
Danish: På ovenstående grundlag finder CHMP benefit/risk-forholdet for Rocephin og relaterede navne positivt og kan godkende de harmoniserede produktinformationer.
English: There is a low incidence of cross allergy between penicillins and 2nd or 3rd generation cephalosporins.
Danish: Der er lav forekomst af krydsallergi mellem penicilliner og anden- og tredjegenerations cefalosporiner.
English: Prophylaxis of perioperative infections
Danish: Profylakse af perioperative infektioner
English: Based on the data presented, the same doses have been recommended for both populations - younger and older adults, provided renal and hepatic function are not relevantly impaired.
Danish: Ud fra forelagte data anbefales samme doser til begge populationer - yngre og ældre voksneforudsat at der ikke er relevant nedsat nyre- eller leverfunktion.
English: One paediatric study was also submitted by the MAH, which enrolled 48 patients aged 2 months to 5 years.
Danish: Indehaveren af markedsføringstilladelsen forelagde desuden en pædiatrisk undersøgelse med 48 patienter i alderen 2 måneder til 5 år.
English: Bacterial Meningitis
Danish: Bakteriel meningitis
English: Ceftriaxone has been shown to be beneficial in both early (Stage II) and late (Stage III) disseminated Lyme borreliosis and is recommended in current clinical guidelines.
Danish: Ceftriaxon er påvist at være gavnligt ved dissemineret Lyme-borreliose i både tidligt (II) og sent (III) stadium, og det anbefales i gældende kliniske retningslinjer.
English: At the request of the CHMP, information on drug-drug interactions (DDI) with anticoagulants was included, with a recommendation that the INR (international normalised ratio) is monitored frequently.
Danish: På anmodning af CHMP er der medtaget oplysninger om lægemiddelinteraktioner med antikoagulantia foruden en anbefaling om hyppig overvågning af INR (international normalised ratio).
English: ‘Purpura fulminans' was deleted as an indication as it was agreed that the condition is a manifestation of specific infections, all of which are already covered in the list of indications.
Danish: “Purpura fulminans” blev slettet som indikation, da den blev anset for at være en manifestation af specifikke infektioner, der i forvejen er dækket af indikationerne.
English: Solvent vials contain either sterile water for injections or 1% lidocaine hydrochloride solution.
Danish: Hætteglassene med solvens indeholder enten sterilt vand til injektionsvæsker eller en 1 % lidokainhydrochloridopløsning.
English: Ceftriaxone distributes primarily into the extracellular space.
Danish: Ceftriaxon fordeles primært i ekstracellulærrummet.
English: Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection.
Danish: Rocephin kan indgives ved intravenøs infusion over mindst 30 minutter (den foretrukne administrationsvej), ved langsom intravenøs injektion over fem minutter eller ved dyb intramuskulær injektion.
English: Bacterial endocarditis
Danish: Bakteriel endokarditis
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Rocephin and associated names (see Annex I).
Danish: anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Rocephin og relaterede navne (se bilag I).
English: • The committee agreed the harmonisation of the summary of product characteristic, labelling and package leaflet proposed by the marketing authorisation holders.
Danish: • udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlen, der er foreslået af indehaverne af markedsføringstilladelse,
English: However in cases of severe renal and hepatic impairment, close clinical monitoring for efficacy and safety has been recommended.
Danish: Ved stærkt nedsat nyreeller leverfunktion anbefales dog tæt klinisk overvågning af sikkerhed og virkning.
English: Ceftriaxone is eliminated unchanged renally (by glomerular filtration) and biliary secretion.
Danish: Ceftriaxon udskilles uændret renalt (ved glomerulær filtration) og ved biliær sekretion.
English: Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.
Danish: Ceftriaxon metaboliseres ikke systemisk, men omdannes af tarmfloraen til inaktive metabolitter.
English: Total and renal plasma clearance (of total, i.e. free plus protein bound) ceftriaxone is dose dependent, while renal clearance of free ceftriaxone clearance is not.
Danish: Den totale og renale plasmaclearance af (totalt, dvs. frit plus proteinbundet) ceftriaxon er dosisafhængig i modsætning til den renale clearance af frit ceftriaxon.
English: Therefore CHMP agreed with the wording proposed of “complicated skin and soft tissue infections”.
Danish: CHMP tilsluttede sig derfor den foreslåede ordlyd “komplicerede infektioner i hud og underliggende væv”.
English: The MAH has reassigned adverse events that have not been observed in studies to the additional category, ‘Not known', with an added explanatory footnote.
Danish: Markedsføringstilladelsesindehaveren har flyttet angivelsen af bivirkninger, der ikke blev iagttaget i undersøgelserne, til tillægskategorien “ukendt” med en forklarende fodnote.
English: Rocephin inhibits bacterial enzymes necessary for cellwall synthesis (peptidoglycan synthesis) causing cell death.
Danish: Rocephin hæmmer bakterielle enzymer, der er nødvendige til syntese af cellevæggen (peptidoglycan-syntese), og medfører derved celledød.
English: • The committee considered the identified divergences for the Rocephin and associated names regarding with respect to the therapeutic indications, posology and method of administration sections, as well as the remaining sections of the SmPC.
Danish: • udvalget behandlede de konstaterede divergenser for Rocephin og relaterede navne hvad angår terapeutiske indikationer, dosering, administrationsvej og de øvrige afsnit i produktresuméet,
English: Strengths available are 250 mg, 500 mg, 1g and 2g.
Danish: Det leveres i styrkerne 250 mg, 500 mg, 1 g og 2 g. Ikke alle styrker markedsføres i alle i EU's medlemsstater.
English: The term convulsions has been added to the tabulated summary of adverse events in section 4.8 of the proposed SmPC following a cumulative review of the events related to convulsions during a Rocephin Periodic Safety Update Report (PSUR) work sharing procedure.
Danish: Betegnelsen kramper er tilføjet i oversigtstabellen over bivirkninger i punkt 4.8 af det foreslåede produktresumé efter en kumulativ gennemgang af kramperelaterede hændelser under en arbejdsdelingsprocedure i forbindelse med en periodisk opdateret sikkerhedsrapport (PSUR) for Rocephin.
English: The conclusions of the harmonisation of the different sections of the SmPC are summarised below.
Danish: I det følgende gives en sammenfatning af konklusionerne om harmoniseringen af produktresuméets forskellige afsnit.
English: Taking into account the data from clinical studies and considerable clinical experience with ceftriaxone in the treatment of meningitis in adults and children the CHMP agreed with the harmonised indication of “Bacterial meningitis”.
Danish: På grundlag af data fra kliniske undersøgelser og omfattende kliniske erfaringer med ceftriaxon til behandling af meningitis hos voksne og børn vedtog CHMP den harmoniserede indikation “bakteriel meningitis”.
English: Rocephin is administered parenterally either by intramuscular injection, intravenous injection or infusion.
Danish: Rocephin administreres parenteralt ved enten intramuskulær injektion, intravenøs injektion eller infusion.
English: Urinary tract infections (UTI), including pyelonephritis
Danish: Urinvejsinfektioner, herunder pyelonefritis
English: The studies report similarly high success rates for both ceftriaxone and the comparator regimens.
Danish: I undersøgelserne er beskrevet lige høje succesrater med ceftriaxon og sammenligningsbehandlingerne.
English: The MAH's proposed text was accepted with minor re-wording.
Danish: Den af markedsføringstilladelsesindehaveren foreslåede tekst blev godkendt med en mindre ændring af ordlyden.
English: From the data presented for the various indications it appears that sufficient patients with bacteraemia were included in the clinical studies, which allow the conclusion that ceftriaxone can be used in the authorised indications when bacteraemia is present.
Danish: Af de forelagte data for de forskellige indikationer fremgår det, at der indgik tilstrækkeligt med patienter med bakteriæmi i de kliniske undersøgelser, hvorfor det kan konkluderes, at ceftriaxon kan anvendes til de godkendte indikationer ved bakteriæmi.