FrancophonIA/ELRC3.0 huggingface dataset:
English: Cisplatin lymphatic system disorders common Granulocytes decreased Leukocytes decreased Haemoglobin decreased Platelets decreased
Danish: Nedsat neutrofiler/ granulocyter Nedsat leukocytter Nedsat hæmoglobin Nedsat trombocytter
English: Pemetrexed Accord 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Accord 100 mg: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat)
English: Pemetrexed Accord 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Accord 1000 mg: Hvert hætteglas indeholder 1000 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed STATEMENT OF ACTIVE SUBSTANCE(S) LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug efter rekonstitution og fortynding.
English: Each vial contains approximately 11 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 11 mg natrium.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Each vial contains approximately 108 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 108 mg natrium.
English: GENERAL CLASSIFICATION FOR SUPPLY INSTRUCTIONS ON USE INFORMATION IN BRAILLE Justification for not including Braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Breast-feeding must be discontinued during pemetrexed therapy (see section
Danish: Amning skal ophøre under behandling med pemetrexed se pkt.
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Accord/ radiation therapy.
Danish: Betændelse i spiserørets overflade er forekommet med Pemetrexed Accord i kombination med strålebehandling.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Accord 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Common Dyspepsia/Heartburn
Danish: Almindelig Dyspepsi/ halsbrand
English: Each vial contains approximately 54 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas indeholder ca. 54 mg natrium.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLAS
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion.
Danish: Pemetrexed Accord 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Accord 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 1000 mg of pemetrexed.
Danish: Hætteglas af type I med grå bromobutylgummiprop og kongeblå ”flip-off”-forsegling indeholdende 1000 mg pemetrexed.
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion.
Danish: Pemetrexed Accord 1000 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with lavender flip-off seal containing 100 mg of pemetrexed.
Danish: Hætteglas af type I med grå bromobutylgummiprop og lavendelfarvet ”flip-off”-forsegling indeholdende 100 mg pemetrexed.
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Common SGPT (ALT) elevation SGOT (AST) elevation
Danish: Almindelig ALAT-forhøjelse ASAT-forhøjelse
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Reconstitute each 1000 mg vial with 40 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 1000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 1000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Common Pain
Danish: Almindelig Forstoppelse
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Edema
Danish: Dosering
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 500 mg of pemetrexed.
Danish: Hætteglas af type I med grå bromobutylgummiprop og kongeblå ”flip-off”-forsegling indeholdende 500 mg pemetrexed.
English: VIAL
Danish: Kvamle
English: The recommended dose of Pemetrexed Accord is 500 milligrams for every square metre of your body's surface area.
Danish: Den anbefalede dosis er baseret på Deres højde og vægt (som anvendes til beregning af legemsoverfladearealet), idet der indgives, hvad der svarer til 500 mg Pemetrexed Accord per kvadratmeter legemsoverflade.
English: JMEN: Kaplan Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Danish: Pemetrexed versus placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller:
English: Time to treatment failure (months)
Danish: OS Time (Months)
English: Common Rash/ desquamation
Danish: Almindelig Udslæt/ hudafskalning
English: CLASSIFICATION FOR SUPPLY
Danish: LISTE OVER HJÆLPESTOFFER
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Danish: Vaccinen begynder at virke syv dage efter vaccinationen, og beskyttelsen varer i 21 dage efter vaccinationen.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Coliprotec F4 den 16/03/2015.
English: Shivering may be seen in more than 1 in 10 pigs after vaccination.
Danish: Kulderystelser ses hos mere end 1 ud af 10 svin efter vaccinationen.
English: In case of accidental ingestion and/or spillage onto skin, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: Ved utilsigtet indtagelse og/eller spild på huden skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Coliprotec F4 overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Coliprotec F4.
English: In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
Danish: I hver undersøgelse blev 350 svin vaccineret med Coliprotec F4, og 350 svin forblev uvaccineret.
English: The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
Danish: Formålet med undersøgelserne var at fastslå, hvor lang tid det tager for svin at opnå fuld beskyttelse, og hvor længe de er beskyttet mod E. coli.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom defences) how to defend itself against a disease.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: In the future, if the animals are exposed to disease-causing bacteria with the F4 protein, the immune system will be able to respond more quickly.
Danish: Hvis dyrene senere igen udsættes for sygdomsfremkaldende bakterier med F4-proteinet, vil immunsystemet reagere hurtigere.
English: It contains live Escherichia coli (E.coli) bacteria of a strain (O8:K87) that does not produce toxins that cause disease.
Danish: Det indeholder levende Escherichia coli (E.coli) bakterier af stamme O8:K87, som ikke producerer sygdomsfremkaldende giftstoffer.
English: The strain of bacteria in the vaccine have this protein but do not produce the toxin that causes the disease.
Danish: Bakterierne i vaccinen tilhører en stamme, der har dette protein, men som ikke producerer det giftstof, der forårsager sygdommen.
English: This will help protect the pigs against E. coli infection and disease.
Danish: Dette beskytter svinene mod infektion og sygdom forårsaget af E. coli.
English: When Coliprotec F4 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Coliprotec F4 gives til svin, registrerer dyrenes immunsystem bakterierne som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: Coliprotec F4 is a vaccine.
Danish: Coliprotec F4 er en vaccine.
English: The withdrawal period for Coliprotec F4 for pigs is zero days.
Danish: Tilbageholdelsestiden for Coliprotec F4 for svin er 0 døgn.
English: Although E.coli is naturally found in the gut, some strains (known as enterotoxigenic strains) produce a toxin that causes diarrhoea, and can result in dehydration, weight loss and occasionally death of the animal.
Danish: E.coli findes naturligt i tarmen, men visse stammer af bakterien producerer et giftstof, der giver diarré og kan medføre dehydrering og væsketab, undertiden med dødelig udgang.
English: Coliprotec F4 is a vaccine that is available as a lyophilisate (a freeze-dried pellet) which is made up into an oral suspension with water.
Danish: Coliprotec F4 er en vaccine, der fås som en frysetørret pellet (et lyofilisat), der opslæmmes i vand til en oral suspension.
English: Vaccines work by ‘teaching' the immune system (the body's natural
Danish: Vacciner virker ved at “lære” organismens naturlige forsvar, immunsystemet, hvordan det skal forsvare organismen mod en sygdom.
English: Both field studies showed that vaccination with Coliprotec F4 reduced the number of pigs with moderate to severe diarrhoea.
Danish: Begge feltundersøgelserne viste, at vaccination med Coliprotec F4 bevirkede, at færre svin fik moderat til svær diarré.
English: Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea.
Danish: Coliprotec F4 gives til svin fra 18-dages alderen for at begrænse forekomsten af moderat til svær fravænningsdiarré forårsaget af E. coli.
English: Other information about Coliprotec F4:
Danish: Andre oplysninger om Coliprotec F4:
English: The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of post-weaning diarrhoea.
Danish: Effektiviteten af Coliprotec F4 blev testet i to feltundersøgelser med svin på brug, hvor der tidligere havde været fravænningsdiarré.
English: Coliprotec F4 is given orally to pigs as a single dose either as a drench or by addition to the drinking water.
Danish: Coliprotec F4 gives gennem munden til svin som en enkeltdosis, enten ved massevaccination eller ved tilsætning til drikkevandet.
English: The main measure of effectiveness was the number of pigs developing diarrhoea.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor mange svin der fik diarré.
English: The types of E.coli associated with post-weaning diarrhoea often produce a protein called F4 on their outer coat that allows them to attach to the cells of the gut.
Danish: De typer E.coli, der er knyttet til fravænningsdiarré, producerer ofte proteinet F4 på deres ydre kappe.
English: What is the risk associated with Coliprotec F4?
Danish: Hvilken risiko er der forbundet med Coliprotec F4?
English: Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Danish: Ved håndtering af vaccinen skal der anvendes personlige værnemidler bestående af beskyttende engangshandsker og øjenværn.
English: Why has Coliprotec F4 been approved?
Danish: Hvorfor blev Coliprotec F4 godkendt?
English: What is Coliprotec F4?
Danish: Hvad er Coliprotec F4?
English: How has Coliprotec F4 been studied?
Danish: Hvordan blev Coliprotec F4 undersøgt?
English: How does Coliprotec F4 work?
Danish: Hvordan virker Coliprotec F4?
English: What benefit has Coliprotec F4 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Coliprotec F4?
English: What is Coliprotec F4 used for?
Danish: Hvad anvendes Coliprotec F4 til?
English: Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Danish: Opfølgende vurdering efter indbringelsesproceduren i henhold til artikel 35 i direktiv 2001/82/EF (EMEA/V/A/089)
English: These included data from companies and from the published literature.
Danish: Dette omfattede data fra virksomheder og offentliggjort litteratur.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: What are the conclusions of the CVMP after the follow-up assessment?
Danish: Hvilke konklusioner traf CVMP efter den opfølgende vurdering?
English: What is enrofloxacin?
Danish: Hvad er enrofloxacin?
English: Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved.
Danish: Efter gennemgangen af de relevante oplysninger, der blev fremsendt i 2013 (under den indledende fase af indbringelsesproceduren), og de yderligere oplysninger, som indehaverne af markedsføringstilladelse har fremsendt som opfølgning på Kommissionens gennemførelsesafgørelse (C(2014) 1484), konkluderede CVMP i februar 2018, at den uafklarede betænkelighed vedrørende optimering af doseringen ved behandling af Escherichia coli-infektioner ikke var løst.
English: It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.
Danish: Det virker mod et bredt spektrum af gramnegative og grampositive bakterier samt Mycoplasma spp.
English: EMA/184512/2018
Danish: marts 2018
English: The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.
Danish: Indehaverne af markedsføringstilladelse blev rådet til at kontakte de nationale kompetente myndigheder i medlemsstaterne for at drøfte de næste skridt til gennemførelse af CVMP's anbefalede ændringer af produktinformationen.
English: Enrofloxacin is an antibiotic belonging to class ‘fluoroquinolones'.
Danish: Enrofloxacin er et antibiotikum, der tilhører "fluoroquinolon"-klassen.
English: Enrofloxacin is for veterinary use only.
Danish: Enrofloxacin er udelukkende beregnet til veterinær anvendelse.
English: At that time, marketing authorisation holders were required to provide more data to justify the dosage of enrofloxacin used in poultry.
Danish: På det tidspunkt blev indehaverne af markedsføringstilladelse anmodet om at fremsende flere data for at begrunde den dosering, der anvendes i fjerkræ.
English: The CVMP has now reviewed these data and has updated its recommendations on the use of enrofloxacin in chickens and turkeys.
Danish: CVMP har nu gennemgået disse data og har opdateret sine anbefalinger om brugen af enrofloxacin hos kyllinger og kalkuner.
English: On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacincontaining medicines administered via drinking water to chickens and turkeys.
Danish: Den 14. februar 2018 opdaterede Det Europæiske Lægemiddelagentur sine anbefalinger for enrofloxacinholdige lægemidler til administration via drikkevand til kyllinger og kalkuner.
English: The CVMP noted that the marketing authorisation holders had not demonstrated that the current dosage regimen for Escherichia coli in chickens and turkeys is optimal from a clinical perspective nor proposed a new dosage regimen.
Danish: CVMP bemærkede, at indehaverne af markedsføringstilladelse ikke havde påvist, at den aktuelle dosering ved behandling af Escherichia coli hos kyllinger og kalkuner er optimal set ud fra et klinisk perspektiv, og at de ikke har foreslået en ny dosering.
English: The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry.
Danish: CVMP fandt, at den aktuelt godkendte dosering kan accelerere udviklingen af bakterieresistens over for enrofloxacin, hvilket ville begrænse brugen af lægemidlet til behandling som sidste udvej i tilfælde af colibacillose hos fjerkræ.
English: In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin.
Danish: I november 2013 fremsatte CVMP en række anbefalinger vedrørende disse lægemidler for at sikre, at de anvendes korrekt hos kyllinger og kalkuner, og for at mindske risikoen for udvikling af resistens over for enrofloxacin.
English: Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?
Danish: Hvorfor blev enrofloxacinholdige veterinærlægemidler til administration via drikkevand til kyllinger og kalkuner vurderet igen?
English: The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin.
Danish: CVMP gennemgik de tilgængelige prækliniske og kliniske data (for kyllinger og kalkuner) for enrofloxacin.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at disse lægemidler ikke længere må anvendes hos kyllinger og kalkuner til behandling af Escherichia coli-infektioner, og at produktinformationen for lægemidler bør ændres i overensstemmelse hermed.
English: Therefore, the CVMP concluded that enrofloxacin should no longer be used for treatment of Escherichia coli infections in chickens and turkeys and recommended that the product information of the concerned products be amended accordingly.
Danish: CVMP konkluderede derfor, at enrofloxacin ikke længere må anvendes til behandling af Escherichia coli-infektioner hos kyllinger og kalkuner, og anbefalede, at produktinformationen for de pågældende lægemidler ændres i overensstemmelse hermed.
English: Alternative options are available.
Danish: Der findes behandlingsalternativer.
English: It is used for the short-term treatment of irritable, non-productive cough.
Danish: Det anvendes til korttidsbehandling af irritativ, ikke-produktiv hoste.
English: GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS
Danish: BEGRUNDELSE FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSEN
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR TILBAGEKALDELSEN AF MARKEDSFØRINGSTILLADELSERNE FREMLAGT AF EMEA
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CLOBUTINOL (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE CLOBUTINOL (se bilag I)
English: 48 healthy volunteers (male and female) were planned to participate according to four sequential groups of twelve volunteers each.
Danish: Der var planlagt deltagelse af 48 raske forsøgspersoner (mandlige og kvindelige) i fire sekventielle grupper på 12 personer hver.
English: The study was prematurely discontinued on day 2 in the third group (720 mg dose group).
Danish: Undersøgelsen blev standset før tid på dag 2 i den tredje gruppe (720 mg).
English: Whereas,
Danish: Idet
English: The multiple rising dose trial was randomised, double-blind and placebo controlled within dose groups.
Danish: Undersøgelsen med stigende doser var randomiseret, dobbeltblind og placebokontrolleret inden for dosisgrupperne.
English: They include tablets, oral solutions, syrups and solutions for injection, and are available over-the-counter in many EU Member States.
Danish: Præparaterne omfatter tabletter, orale opløsninger, syrupper og injektionsvæsker, der i mange EU-medlemsstater fås i håndkøb.