FrancophonIA/ELRC3.0 huggingface dataset:
English: This phase III study was designed as a prospective, parallel-group, double-blind, placebo comparison of the clinical efficacy and safety of fixed dose combination (2 tablets, each tablet containing 500 mg paracetamol and 150 mg ibuprofen) versus its individual components (either 1000 mg paracetamol or 300 mg ibuprofen) and versus placebo in 300 patients suffering of moderate to severe pain due to post-arthroscopy surgery of the knee.
Danish: Denne fase III-undersøgelse var designet som en prospektiv, dobbeltblind, placebokontrolleret parallelgruppeundersøgelse, der sammenlignede den kliniske virkning og sikkerheden af fastdosiskombinationen (2 tabletter, hver tablet indeholdende 500 mg paracetamol og 150 mg ibuprofen) versus de enkelte komponenter (enten 1 000 mg paracetamol eller 300 mg ibuprofen) og versus placebo hos 300 patienter med moderate til svære smerter efter artroskopi af knæleddet.
English: When comparing with past users, for most safety outcomes, current users of concomitant paracetamol and ibuprofen had relative rates between those for current users of ibuprofen alone and paracetamol alone.
Danish: I forhold til tidligere brugere gælder det for nuværende brugere, at de relative andele af de fleste sikkerhedsudfald for brugere af paracetamol sammen med ibuprofen ligger mellem andelene for brugere af ibuprofen alene og af paracetamol alene.
English: Study AFT -MX6 was another phase III, placebo-controlled, prospective, randomised, double-blind, parallel-design trial with a safety follow-up at Day 30.
Danish: Undersøgelse AFT-MX6 var endnu en placebokontrolleret, prospektiv, randomiseret, dobbeltblind, fase III-parallelgruppeundersøgelse med sikkerhedsopfølgning på dag 30.
English: Major issues on efficacy and safety raised by several CMS remained unresolved and were considered as a potential serious risk to public health; hence the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 29(1) of Directive 2001/83/EC.
Danish: Proceduren blev derfor indbragt for Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) i henhold til artikel 29, stk. 1, i direktiv 2001/83/EF.
English: Its objective was to compare the analgesic effects and safety of paracetamol and ibuprofen combined versus paracetamol alone or ibuprofen alone in adults with postoperative pain.
Danish: Formålet var at sammenligne den analgetiske virkning og sikkerheden af kombinationen paracetamol/ibuprofen vs. paracetamol alene eller ibuprofen alene ved postoperative smerter hos voksne.
English: In conclusion, the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Danish: Som konklusion synes den kendte risiko for de undersøgte sikkerhedsudfald ikke at ændres ved samtidig anvendelse af ibuprofen og paracetamol i forhold til paracetamol eller ibuprofen alene.
English: The CHMP accepted this justification by the applicant for the need for the fixed dose combination in short term treatment of acute pain is acceptable for the several reasons.
Danish: CHMP accepterede ansøgerens begrundelser af behovet for fastdosiskombinationen til korttidsbehandling af akutte smerter.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Danish: • udvalget gennemgik alle de oplysninger, som ansøgeren havde fremlagt til støtte for virkningen af fastdosiskombinationen paracetamol/ibuprofen 500 mg/150 mg filmovertrukne tabletter og relaterede navne til kortvarig symptomatisk behandling af lette til moderate smerter,
English: Appropriately, instructions in the posology section and warnings for the duration of use were provided in the product information.
Danish: Produktinformationen indeholder passende anvisninger i afsnittet om dosering og advarsler om anvendelsesvarigheden.
English: Finally in terms of safety there is supportive data to exclude any additive adverse effects on gastric erosions and bleeding when paracetamol is added to ibuprofen in the ratio of 3.3:1, and the efficacy provided by the fixed dose combination over either of the individual components does show any decreased tolerability/safety.
Danish: Hvad endelig sikkerheden angår, udelukker de støttende data eventuelle uønskede additive virkninger på gastrisk erosion og blødning, når paracetamol kombineres med ibuprofen i forholdet 3,3:1.
English: The proposed combination therefore offers an alternative therapeutic option to such opioid based combinations.
Danish: I stedet for sådanne kombinationer er den påtænkte kombination derfor en alternativ behandlingsmulighed.
English: The important safety risk associated with prolonged use of paracetamol and ibuprofen are well known and are hepatotoxicity, peptic ulceration and gastrointestinal bleeding, nephrotoxicity, cardiac, cardiovascular and cerebrovascular effects .The applicant has provided a comprehensive review of the safety data both from the submitted studies and from overall pooled study data including the exposure of the combination in elderly patients.
Danish: De vigtige sikkerhedsrisici ved langtidsanvendelse af paracetamol og ibuprofen er velkendte og består i hepatotoksicitet, ulcus pepticum og gastrointestinal blødning, nefrotoksicitet samt kardiale, kardiovaskulære og cerebrovaskulære effekter.
English: Study AFT-MX-4 was a phase II exploratory study with a double-blind, randomized, parallel group comparison of the effects of Paracetamol and Ibuprofen Combined with Paracetamol, Low and High Dose Ibuprofen on Patients with Pain from Osteoarthritis of the Knee, and a 12 month open label extension.
Danish: Undersøgelse AFT-MX-4 var en fase II-forundersøgelse med en dobbeltblind, randomiseret parallelgruppesammenligning af virkningen af paracetamol, ibuprofen kombineret med paracetamol samt lav og høj dosis ibuprofen hos patienter med smerter fra osteoartritis i knæet, og en 12måneders åben forlængelse.
English: Study AFT-MX-1 was a phase III, pivotal study with a prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with postoperative pain.
Danish: Undersøgelse AFT-MX-1 var en prospektiv, dobbeltblindet fase III-hovedundersøgelse med parallelle grupper af den analgetiske virkning af en kombination af paracetamol og ibuprofen, paracetamol alene eller ibuprofen alene hos patienter med postoperative smerter.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Danish: • udvalget er af den opfattelse, at de foreliggende data underbygger virkningen af filmovertrukne tabletter med en fastdosiskombination af paracetamol/ibuprofen 500 mg/150 mg og associerede navne til kortvarig symptomatisk behandling af lette til moderate smerter,
English: Study AFT-MX-3 was a dose response study and a double-blind, placebo-controlled, randomised, parallel group comparison of the effects of different paracetamol and ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars.
Danish: Undersøgelse AFT-MX-3 var en dosisresponsundersøgelse og en dobbeltblindet, placebokontrolleret, randomiseret parallelgruppesammenligning af virkningen af forskellige kombinerede doser af paracetamol og ibuprofen i forhold til placebo hos deltagere med smerter efter fjernelse af 2-4 tredjemolarer.
English: Furthermore in a study population which included 1.2 million patients, whose aim was to evaluate and compare the risk of specific safety outcomes in patients prescribed ibuprofen and paracetamol concomitantly with those in patients prescribed ibuprofen or paracetamol alone, concluded that the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with the mono-components alone.
Danish: Hos en undersøgelsespopulation på 1,2 millioner patienter ønskede man endvidere at evaluere risikoen for bestemte sikkerhedsudfald for patienter, der havde fået ordineret ibuprofen og paracetamol samtidig, og sammenligne med udfaldet hos dem, der havde fået ordineret ibuprofen eller paracetamol alene.
English: Therefore the risk for prolonged use of the fixed dose combination and Paracetamol or Ibuprofen alone should have a similar risk/benefit profile.
Danish: Hvad angår risikoen for langvarig anvendelse må fastdosiskombinationen derfor forventes at have samme risk/benefit-profil som paracetamol eller ibuprofen alene.
English: In conclusion, the safety outcomes examined were consistent in the concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Danish: Som konklusion svarede de undersøgte sikkerhedsudfald ved samtidig anvendelse af ibuprofen og paracetamol til paracetamol eller ibuprofen alene.
English: Instructions in the posology section and warnings for the duration of use were provided in the product information.
Danish: Produktinformationen indeholder doseringsanvisninger og advarsler om anvendelsesvarigheden.
English: CVMP started the procedure on 6 November 2007.
Danish: CVMP startede proceduren den 6. november 2007.
English: horse oral
Danish: hest oral
English: 3421 GW Oudewater The Netherlands
Danish: 3421 GW Oudewater Holland
English: The applicant was requested to provide the following information: 1.
Danish: Ansøgeren blev bedt om at fremskaffe følgende oplysninger:
English: France considers that the dosing regime of the product is not correct.
Danish: Frankrig mente, at doseringsregimet for produktet ikke var korrekt.
English: paste
Danish: pasta
English: The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Danish: Målet med vurderingen er at bestemme, hvorvidt markedsføringstilladelserne for de veterinære lægemidler, der er inkluderet i indbringelsesproceduren, skal opretholdes, suspenderes, ændres eller tilbagekaldes i betragtning af årsagen til indbringelsen.
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Danish: Derfor gælder de samme konklusioner vedrørende effektivitet og sikkerhed for begge produkter.
English: This may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Danish: Dette kan føre til manglende effektivitet og udvikling af modstandsdygtighed hos de patogene målorganismer, hvilket muligvis kan medføre risiko for menneskers helbred, når det drejer sig om zoonotiske bakterier.
English: On 16 November 2007 responses to the questions were received from MAH and the clock restarted.
Danish: Den 16. november 2007 blev svar på spørgsmålene modtaget fra MAH, og proceduren blev startet igen.
English: 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
Danish: 5 mg trimethoprim og 25 mg sulfadiazin pr. kg kropsvægt pr. dag i maksimalt 5 dage.
English: In response to question 2, the applicant pointed out that there are no differences at all that would justify different conclusions on the safety and efficacy for the two products.
Danish: Som svar på spørgsmål 2 påpegede ansøgeren, at der ikke er nogen forskel overhovedet mellem de to produkter, der ville kunne retfærdiggøre forskellige konklusioner vedrørende produkternes sikkerhed og effektivitet.
English: A list of questions was adopted on 8 November 2007 and sent to the marketing authorisations holders (MAH), by which the procedure clock was stopped.
Danish: Den 8. november 2007 blev der udarbejdet en liste over spørgsmål, der blev sendt til indehaverne af markedsføringstilladelsen (MAH), hvorved proceduren blev stillet i bero.
English: Applicant or Marketing
Danish: Ansøger eller indehaver af markedsføringstilladelse
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Danish: Som svar på spørgsmål 1 sendte ansøgeren en kopi af det originale dossier, der blev indleveret med ansøgningen i den decentraliserede procedure, samt alle supplementære data, der blev indsendt i løbet af den decentraliserede procedure som svar på fase I og fase II vurderingen og den efterfølgende indbringelsesprocedure i CMD(v).
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Danish: Ifølge Rådets direktiv 2001/82/EF, artikel 33, stk. 4, med senere ændringer blev sagen henvist til CVMP.
English: The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992.
Danish: Det originale referenceprodukt "Tribrissen oral pasta" blev tilladt i Holland i 1992.
English: 333.3 mg/g sulfadiazine and 66.7 mg/g trimethoprim.
Danish: 333,3 mg/g sulfadiazin og 66,7 mg/g trimethoprim.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France) at day 210 of the decentralised procedure.
Danish: De gældende versioner af produktresume, etikettering og indlægsseddel er dem, der er vedtaget af referencemedlemsstaten og de interesserede medlemsstater (bortset fra Frankrig) på den decentraliserede procedures dag 210.
English: The objections raised by France should not prevent the granting of a marketing authorisation for Equibactin vet.
Danish: De indvendinger Frankrig fremførte bør ikke forhindre, at der gives markedsføringstilladelse for Equibactin vet. oral pasta.
English: Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product, and can claim the same indications for use and the same precautionary warnings to ensure safe use for the product as for the reference product Tribrissen Oral Paste.
Danish: Under disse omstændigheder er ansøgeren undtaget fra at fremlægge yderligere prækliniske eller kliniske data vedrørende det foreslåede produkts effektivitet og kan hævde, at der gælder de samme indikationer og samme sikkerhedsadvarsler til at sørge for sikker brug af produktet som for referenceproduktet Tribrissen oral pasta.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I NAVN, LÆGEMIDDELFORM, LÆGEMIDDELSTYRKE, DYREARTER, INDGIVELSESVEJE OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses.
Danish: Nederlandene, referencemedlemsstaten i den decentraliserede procedure, meddelte EMEA den 24. september 2007, at koordineringsgruppen for gensidige anerkendelsesprocedurer og decentraliserede procedurer - Veterinære lægemidler (CMD(v)) ikke var nået til enighed vedrørende Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste.
English: Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses.
Danish: Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste.
English: CVMP noted that Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses is a generic of Tribrissen oral paste (authorised in the Netherlands) and that the concerns raised by France can only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Danish: CVMP bemærkede, at Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste er identisk med Tribrissen oral pasta (tilladt i Holland), og at de betænkeligheder, Frankrig har rejst, kun kan løses inden for rammen af denne procedure, hvis eventuelle forskelle mellem de to produkter kan retfærdiggøre andre konklusioner vedrørende sikkerhed og effektivitet.
English: Frequency and route of administration
Danish: Dyrearter Indgivelsesvej og hyppighed
English: A copy of the dossier of Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v).
Danish: En kopi af dossieret for Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste og alle supplerende oplysninger, der var føjet til dossieret indtil indbringelsesprocedurens dag 60 hos CM(v).
English: Consequently, the conclusions on efficacy and safety for the reference product, Tribrissen oral paste, can be extended to the generic product, Equibactin vet.
Danish: Konklusionerne vedrørende effektiviteten og sikkerheden for referenceproduktet, Tribrissen oral pasta, udvides derfor til også at gælde for det generiske produkt, Equibactin vet. oral pasta.
English: Equibactin vet Oral Paste proved to be essentially similar to the reference product, Tribrissen Oral Paste.
Danish: Equibactin vet. oral pasta har vist sig at være grundlæggende magen til referenceproduktet, Tribrissen oral pasta.
English: In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products.
Danish: I betragtning af Frankrigs betænkeligheder blev ansøgeren bedt om at angive og dokumentere, hvor det er nødvendigt, enhver forskel mellem Equibactin vet. (333 mg/g + 67 mg/g) oral pasta til heste og referenceproduktet Tribrissen oral pasta (tilladt i Holland), der kan retfærdiggøre forskellige konklusioner vedrørende de to produkters sikkerhed og effektivitet.
English: Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/4064 in the UK).
Danish: I en bioækvivalensundersøgelse med GLP enkelt dosis hos heste, som blev udført i henhold til passende retningslinjer, viste Equibactin vet. oral pasta til heste sig at være bioækvivalent med referenceproduktet Tribrissen (REG NL 5055 i Holland) og Tribissen (Vm 0201/4064 i Storbritannien).
English: Oral Paste in accordance with the outcome of referral procedure EMEA/V/023 under Article 35 of Directive 2001/82/EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Danish: Det anbefales at ændre Equibactin vet. oral pasta, i overensstemmelse med udfaldet af indbringelsesprocedure EMEA/V/023 i henhold til artikel 35 i direktivet 2001/82/EF med senere ændringer, for referencelægemidlet Tribrissen oral pasta, der er godkendt i Holland.
English: Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055).
Danish: Der er desuden kun lighedspunkter, der beviser at sikkerhed og effektivitet for Equibactin vet oral pasta til heste er de samme som for referenceproduktet Tribrissen oral pasta (tilladt i Holland under REG NL 5055).
English: Based on the identical composition with respect to active ingredients, Trimethoprim and Sulfadiazine, the same pharmaceutical form, and proven bioequivalence between Equibactin vet.
Danish: Da sammensætningen af de to aktive ingredienser, trimethoprim og sulfadiazin, er identiske, lægemiddelformen er den samme, og da der er bioækvivalens mellem Equibactin vet. oral pasta og Tribrissen oral pasta for både trimethoprim og sulfadiazin, kan produkterne betragtes som værende grundlæggende ens.
English: Esmya received a marketing authorisation valid throughout the European Union on 23 February 2012.
Danish: Esmya fik en markedsføringstilladelse med gyldighed i hele EU den 23. februar 2012.
English: 1 See outcome of safety review carried out in 2018 here.
Danish: Se resultatet af sikkerhedsgennemgangen i 2018 her.
English: It is available as tablets (5 mg) to be taken by mouth.
Danish: Det fås som tabletter (5 mg), der tages gennem munden.
English: The recommended dose is one tablet a day for up to three months (one treatment course).
Danish: Den anbefalede dosis er én tablet dagligt i op til tre måneder (ét behandlingsforløb).
English: Esmya can be given:
Danish: Esmya kan gives:
English: Further information on Esmya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Esmya findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Treatment should always be started during the first week of the menstrual period.
Danish: Behandlingen bør altid påbegyndes i den første uge af det månedlige blødningsforløb (menstruationscyklussen).
English: Esmya (ulipristal acetate)
Danish: Esmya (ulipristalacetat)
English: Other information about Esmya
Danish: Andre oplysninger om Esmya
English: As for all medicines, data on the use of Esmya are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Esmya løbende overvåget.
English: An overview of Esmya and why it is authorised in the EU
Danish: En oversigt over Esmya og hvorfor det er godkendt i EU
English: A reduction in fibroid size was also observed.
Danish: Der blev ligeledes iagttaget reduktion i knudernes størrelse.
English: The European Medicines Agency decided that the benefits of Esmya outweigh its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Esmya opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For more information about using Esmya, see the package leaflet or contact your doctor or pharmacist.
Danish: For yderligere oplysninger om brug af Esmya, se indlægssedlen, eller kontakt din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Esmya?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Esmya?
English: Side effects reported with Esmya are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet for Esmya vurderes omhyggeligt, og der foretages de nødvendige forholdsregler for at beskytte patienterne.
English: The size of the fibroids was also smaller in women treated with Esmya than in those who received placebo.
Danish: Også størrelsen af knuderne var mindre hos kvinder, der blev behandlet med Esmya, end hos dem, der blev behandlet med placebo.
English: Long-term treatment with Esmya has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Esmya.
Danish: Langvarig behandling med Esmya er blevet undersøgt i et hovedstudie omfattende 451 kvinder, som gennemgik fire behandlingsforløb med 5 eller 10 mg Esmya af tre måneders varighed.
English: • as a single treatment course in women before they have surgery for their fibroids;
Danish: • som et enkelt behandlingsforløb hos kvinder, før de bliver opereret for knuder