natgillin/translations-raw huggingface dataset:
Undersøgelsen omfattede mænd og kvinder i alderen 18 til 60 år, der operativt fik fjernet mindst to impakterede tredjemolarer.
Male and female participants aged 18 and 60 years undergoing surgical removal of least two impacted third molars were eligible for this study.
• udvalget konkluderede ved en flertalsafgørelse, at benefit/risk-forholdet er positivt for dette lægemiddel til kortvarig symptomatisk behandling af lette til moderate smerter.
• The Committee concluded by majority that the benefit risk balance of this medicinal product in the short-term symptomatic treatment of mild to moderate pain is favourable.
De vurderede sikkerhedsudfald var øvre gastrointestinale hændelser, myokardieinfarkt, apopleksi, nyresvigt (eksklusive kronisk), kongestivt hjertesvigt, forsætlig eller uforsætlig overdosering, suicidaladfærd og dødelighed.
The safety outcomes evaluated were upper gastrointestinal events, myocardial infarction, stroke, renal failure (excluding chronic), congestive heart failure, intentional or accidental overdose, suicidal behaviour and mortality.
Dataene fra AFT-MX-1 underbygges af den store fase III-undersøgelse af virkning AFT-MX-6.
The data obtained in AFT-MX-1 is reinforced by the large Phase III efficacy study AFT-MX-6.
Dette lægemiddel er i mange EU-lande i forvejen godkendt som receptpligtigt lægemiddel i forbindelse med den første og anden bølge af den decentrale procedure.
This medicinal product is already authorised during the first and second waves of the decentralised procedure as prescription only medicine in many EU countries.
• udvalget er desuden af den opfattelse, at der i den foreslåede produktinformation og den opdaterede risikostyringsplan er medtaget tilstrækkelige oplysninger til at minimere enhver risiko for anvendelse ud over den anbefalede varighed på maksimalt 3 dage, hvad dette angår.
• The Committee is also of the opinion that adequate information in order to minimise any risk of use outside of the recommended duration of use of maximum of 3 days has been included in the proposed product information and in the updated risk management plan, in this regard.
CHMP anmodede om, at de specifikke advarsler for de særlige patientpopulationer med nedsat lever- og nyrefunktion i forbindelse med anvendelse af paracetamol alle bringes i overensstemmelse med de eksisterende advarsler i produktinformationen for monokomponenten af hensyn til fuldstændigheden af sikkerhedsoplysningerne.
The CHMP requested that specifically for the special populations of hepatic and renal impaired patients the warnings related to paracetamol use are all in line with the warnings existing in the mono-component's product information, for completeness of the safety information.
Vale Pharmaceuticals indsendte den 27. marts 2015 en ansøgning til Det Forenede Kongerige i henhold til den decentrale procedure (DCP) for en fastdosiskombination af paracetamol 500 mg og ibuprofen 150 mg.
Vale Pharmaceuticals submitted to the United Kingdom an application under the decentralised procedure (DCP) for Paracetamol 500mg and Ibuprofen 150mg fixed dose combination on 27 March 2015.
CHMP anbefalede også korttidsanvendelse (højst tre dage) af denne fastdosiskombination.
The CHMP also recommended the short term use (max for 3 days) of this fixed dose combination.
CHMP-medlemmer har udtrykt nogen betænkelighed ved, at den påviste overlegenhed er begrænset til én postoperativ smertemodel (molar ekstraktion), at en anden hovedundersøgelse ikke kunne påvise overlegenheden af kombinationen med en anden smertemodel (artroskopi), og at der ikke var evidens for overlegenhed ved behandling af lette smerter.
CHMP members has expressed some concerns regarding the demonstrated superiority being limited to one post-operative pain model (molar extraction), that another pivot study failed to demonstrate the superiority of the association in another pain model (arthroscopy), and that there was no evidence available of superiority in the treatment of mild pain.
Resultaterne viste, at kombinationen af paracetamol og ibuprofen havde større analgetisk virkning end samme dosis ibuprofen alene.
The results showed that the combination of paracetamol and ibuprofen had greater analgesic efficacy than the same dose of ibuprofen alone.
Derudover er sikkerhedsoplysningerne skærpet vedrørende særlige populationer, herunder ældre og patienter med nedsat lever- og nyrefunktion, så de afspejler advarslerne for anvendelse af enkeltkomponenterne,
In addition the safety information on special populations, including elderly, hepatic and renal impaired patients was strengthened to reflect the warnings related to mono-component use.
De dosisstyrker, der anvendes i den påtænkte fastdosiskombination, ligger et godt stykke inden for det anbefalede dosisområde, især dosis af ibuprofen.
The dose strengths used in the proposed fixed dose combination are well within the recommended dose range, particularly with regards to the dose of ibuprofen.
I den primære endepunktsanalyse blev der taget hensyn til forbruget af redningsmedicin ved at fremføre VAS-smertescore fra før redningsmedicinen.
Rescue medication consumption was accounted for in the primary endpoint analysis by carrying forward the pre-rescue VAS pain score.
3 dage) af denne fastdosiskombination anbefales af CHMP og er accepteret af ansøgeren.
The short term use (max for 3 days) of this fixed dose combination has been recommended by the CHMP and accepted by the applicant.
De problemer, der begrundede indbringelsen for CHMP, var navnlig, at rationalet for fastdosiskombinationen ikke anses for berettiget, at den ekstra fordel ved denne nye fastdosiskombination i forhold til monokomponenterne ikke er godtgjort, og at der ikke er påvist en acceptabel sikkerhedsprofil for den nye fastdosiskombination.
The main issues were the basis of the referral to CHMP which were that the rationale of the fixed dose combination is not considered justified, the additional benefit for this new fixed dose combination compared to the mono-components has not been demonstrated and that an acceptable safety profile of the new fixed-dose combination has not been shown.
PSUR'erne dækker utvivlsomt de faktiske erfaringer på markedet mht. alder og anvendelse.
The PSURs would undoubtedly cover a range of ages and uses based upon real in market experience.
Hvad angår sikkerheden af denne fastdosiskombination førte vurderingen af dataene i de kliniske undersøgelser samt PSUR'en og en omfattende litteratursøgning til den konklusion, at de kendte sikkerhedsudfald ved samtidig anvendelse af ibuprofen og paracetamol er som forventet i forhold til enkeltkomponenterne alene.
With regards the safety of this fixed dose combination, following the assessment of the data in the clinical trials as well as the PSUR and an extensive search of the published literature concluded that the known safety outcomes are expected by concomitant use of ibuprofen and paracetamol compared with the mono-components alone.
Ansøgerens rationale, der beskrev behovet for fastdosiskombinationen til korttidsbehandling af akutte smerter, blev forelagt for CHMP.
The rationale of the applicant presented the need for the fixed dose combination in short term treatment of acute pain was presented to the CHMP.
CHMP anbefalede ved en flertalsafgørelse udstedelse af markedsføringstilladelse, for hvilken produktresuméet, etiketteringen og indlægssedlen er ændret i henhold til den endelige version, der er udarbejdet under behandlingen i koordinationsgruppen som angivet i bilag III for filmovertrukne tabletter indeholdende en fastdosiskombination af paracetamol/ibuprofen 500 mg/150 mg samt relaterede navne.
Having considered the above, the CHMP has recommended by majority the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet was amended following the final version achieved during the Coordination group procedure as mentioned in Annex III for Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination.
Forekomsten af bivirkninger er som forventet og omfatter hovedsagelig mave-tarmkanalen.
The incidence of adverse events is as expected and most commonly involves the gastrointestinal tract.
I mangel af denne fastdosiskombination vil der som redningsmedicin ved smerter stedet blive anvendt opioider.
In absence of this fixed dose combination the rescue remedy for the pain is resulting in use of opioids, instead.
Dens formål var at sammenligne den analgetiske virkning og kliniske sikkerhed af kombinationen (paracetamol 500 mg og ibuprofen 150 mg) med de andre 3 behandlingsgrupper (paracetamol 500 mg, lavdosis-ibuprofen 150 mg, højdosis-ibuprofen 300 mg) hos patienter med smerter fra slidgigt i knæet.
Its objective was to compare the analgesic efficacy and clinical safety of Combination (paracetamol 500mg and ibuprofen 150 mg) with the other 3 treatment groups (paracetamol 500 mg; low dose ibuprofen 150 mg; high dose ibuprofen 300mg) in patients who have painful osteoarthritis of the knee.
Kliniske undersøgelser med fastdosiskombinationen har heller ikke vist andre bivirkninger end dem, der kendes for paracetamol alene eller ibuprofen alene.
Clinical trials with the fixed dose combination have also not indicated any other undesirable effects other than those known for paracetamol alone or ibuprofen alone).
CHMP fandt, at benefit/risk-forholdet for filmovertrukne tabletter med fastdosiskombinationen af paracetamol/ibuprofen 500 mg/150 mg og relaterede navne kan anses for positivt, når de anvendes i overensstemmelse med produktoplysningerne.
The CHMP was of the opinion that the benefit-risk balance of Paracetamol / ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination is considered to be favourable when used in accordance with the terms of the product information.
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.
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.
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.
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.
Undersøgelse AFT-MX6 var endnu en placebokontrolleret, prospektiv, randomiseret, dobbeltblind, fase III-parallelgruppeundersøgelse med sikkerhedsopfølgning på dag 30.
Study AFT -MX6 was another phase III, placebo-controlled, prospective, randomised, double-blind, parallel-design trial with a safety follow-up at Day 30.
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.
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.
Formålet var at sammenligne den analgetiske virkning og sikkerheden af kombinationen paracetamol/ibuprofen vs. paracetamol alene eller ibuprofen alene ved postoperative smerter hos voksne.
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.
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.
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.
CHMP accepterede ansøgerens begrundelser af behovet for fastdosiskombinationen til korttidsbehandling af akutte smerter.
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.
• 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,
• 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.
Produktinformationen indeholder passende anvisninger i afsnittet om dosering og advarsler om anvendelsesvarigheden.
Appropriately, instructions in the posology section and warnings for the duration of use were provided in the product information.
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.
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.
I stedet for sådanne kombinationer er den påtænkte kombination derfor en alternativ behandlingsmulighed.
The proposed combination therefore offers an alternative therapeutic option to such opioid based combinations.
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.
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.
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.
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.
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.
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.
• 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,
• 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.
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.
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.
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.
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.
Hvad angår risikoen for langvarig anvendelse må fastdosiskombinationen derfor forventes at have samme risk/benefit-profil som paracetamol eller ibuprofen alene.
Therefore the risk for prolonged use of the fixed dose combination and Paracetamol or Ibuprofen alone should have a similar risk/benefit profile.
Som konklusion svarede de undersøgte sikkerhedsudfald ved samtidig anvendelse af ibuprofen og paracetamol til paracetamol eller ibuprofen alene.
In conclusion, the safety outcomes examined were consistent in the concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone.
Produktinformationen indeholder doseringsanvisninger og advarsler om anvendelsesvarigheden.
Instructions in the posology section and warnings for the duration of use were provided in the product information.
CVMP startede proceduren den 6. november 2007.
CVMP started the procedure on 6 November 2007.
hest oral
horse oral
3421 GW Oudewater Holland
3421 GW Oudewater The Netherlands
Ansøgeren blev bedt om at fremskaffe følgende oplysninger:
The applicant was requested to provide the following information: 1.
Frankrig mente, at doseringsregimet for produktet ikke var korrekt.
France considers that the dosing regime of the product is not correct.
pasta
paste
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.
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.
Derfor gælder de samme konklusioner vedrørende effektivitet og sikkerhed for begge produkter.
Consequently, the same conclusions on efficacy and safety apply to both products.
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.
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.
Den 16. november 2007 blev svar på spørgsmålene modtaget fra MAH, og proceduren blev startet igen.
On 16 November 2007 responses to the questions were received from MAH and the clock restarted.
5 mg trimethoprim og 25 mg sulfadiazin pr. kg kropsvægt pr. dag i maksimalt 5 dage.
5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
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.
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.
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.
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.
Ansøger eller indehaver af markedsføringstilladelse
Applicant or Marketing
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).
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.
Ifølge Rådets direktiv 2001/82/EF, artikel 33, stk. 4, med senere ændringer blev sagen henvist til CVMP.
Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Det originale referenceprodukt "Tribrissen oral pasta" blev tilladt i Holland i 1992.
The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992.
333,3 mg/g sulfadiazin og 66,7 mg/g trimethoprim.
333.3 mg/g sulfadiazine and 66.7 mg/g trimethoprim.
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.
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.
De indvendinger Frankrig fremførte bør ikke forhindre, at der gives markedsføringstilladelse for Equibactin vet. oral pasta.
The objections raised by France should not prevent the granting of a marketing authorisation for Equibactin vet.
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.
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.