FrancophonIA/ELRC3.0 huggingface dataset:
English: On 21 October 2016 the RMS United Kingdom therefore triggered a referral under Article 29(4) of Directive 2001/83/EC as these issues were considered to be a potential serious risk to public health.
Danish: Den 21. oktober 2016 foretog referencemedlemsstaten Det Forenede Kongerige derfor en indbringelse i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF, idet disse spørgsmål blev betragtet som en potentiel alvorlig risiko for den offentlige sundhed.
English: The applicant noted also the PSUR reports which cover over 89 million tablets of market use have not suggested any additional or unexpected risks.
Danish: Ansøgeren bemærkede desuden, at PSURrapporter, der omfatter over 89 millioner tabletter anvendt på markedet, ikke har tydet på yderligere eller uventede risici.
English: The primary objective showed that the combination was statistically superior to the active substances individually.
Danish: Det primære mål påviste, at kombinationen var statistisk overlegen i forhold til de aktive stoffer hver for sig.
English: Thirdly, there is a medical need for a new fixed dose combination analgesic that does not contain an opioid component for relief of acute pain.
Danish: For det tredje er der et medicinsk behov for en ny analgetisk fastdosiskombination uden opioidkomponent til lindring af akutte smerter.
English: Therefore such a potential has virtually no impact on the benefit-risk status of the medicinal product.
Danish: Dette potentiale er derfor så godt som uden betydning for status af lægemidlets benefit/risk-forhold.
English: The primary efficacy endpoint was the time-adjusted sum of pain intensity differences from baseline over a 48 hour period.
Danish: Det primære endepunkt for virkningen var den tidsjusterede sum af forskellene i smerteintensitet i forhold til baseline i løbet af 48 timer.
English: Linear interpolation was use to estimate intermittent missing values.
Danish: Intermitterende manglende værdier blev estimeret ved lineær interpolation.
English: In the study the active substances have all been shown to be statistically superior to placebo.
Danish: Undersøgelsen viste, at alle de aktive stoffer var statistisk overlegne i forhold til placebo.
English: The results from AFT-MX-6 are consistent with AFT-MX-1 which in fact further reinforces the validity of the AFT-MX-1 results.
Danish: Resultaterne fra AFT-MX-6 er i overensstemmelse med AFT-MX-1, hvilket reelt yderligere styrker validiteten af resultaterne af AFT-MX-1.
English: The results showed that the combination provided significantly greater pain relief than either mono-component (p<0.001).
Danish: Resultaterne viste, at kombinationen medførte signifikant større smertelindring end nogen af enkeltkomponenterne (p <0,001).
English: Having considered all the data submitted by the applicant, the CHMP considered that the benefit-risk balance was adequately demonstrated.
Danish: Efter at have taget alle de af ansøgeren forelagte data i betragtning vurderede CHMP, at benefit/risk-forholdet var tilfredsstillende godtgjort.
English: Firstly, the two active substances in this fixed dose combination are supported by extensive published and regulatory evidence and history of efficacy and safety.
Danish: For det første understøttes de to aktive stoffer i denne faste kombination af omfattende publiceret og regulatorisk evidens og erfaringer, der viser deres virkning og sikkerhed.
English: Rationale for use of the fixed dose combination ratio
Danish: Rationalet for kombinationsforholdet i fastdosiskombinationen
English: Despite the non-systematic pain reporting of VAS assessments, the pain duration over which subjects assessed their pain was similar between the groups, thus enabling a standardised comparison.
Danish: Selv om indberetningen af smerter i VAS-vurderingerne var usystematisk, var den smertevarighed, i løbet af hvilken patienterne vurderede smerterne, den samme i de forskellige grupper, hvilket giver mulighed for en standardiseret sammenligning.
English: The fixed dose combination avoids the need to move to opioids with all their implications regarding safety and addiction risks.
Danish: Med fastdosiskombinationen undgås behovet for at skifte til opioider med konsekvenser heraf i form af sikkerheds- og afhængighedsrisici.
English: A variety of reports show that the addition of codeine to common non-opioid analgesics provides additional pain relief at the cost of tolerability, compromising the benefit-risk ratio.
Danish: En række rapporter viser, at tilføjelse af kodein til almindelige analgetika uden opioider giver supplerende smertelindring på bekostning af tolerabiliteten og kompromitterer benefit/risk-forholdet.
English: Secondly the ratio of paracetamol to ibuprofen (3.3:1) is of paramount importance as there is a distinct additive effect in both acute and chronic pain models, which is lost if the ratio is decreased.
Danish: For det andet har forholdet mellem paracetamol og ibuprofen (3,3: 1) afgørende betydning, da der i modeller for både akutte og kroniske smerter er en udtalt additiv virkning, som mistes, hvis forholdet nedsættes.
English: As the proposed fixed dose combination is recommended to be used for no more than 3 days, the potential for prolonged use is largely mitigated.
Danish: Da den påtænkte fastdosiskombination frarådes anvendt i mere end 3 dage, reduceres potentialet for langvarig anvendelse væsentligt.
English: Furthermore, for this substance combination, there is no interference with their individual metabolic pathways, and they also act through different pharmacological pathways.
Danish: For denne stofkombination er der desuden ingen interferens med hvert af stoffernes metaboliseringsvej, og deres farmakologiske virkningsmekanisme er forskellig.
English: The applicant noted that prolonged use exceeding the recommended three-day period may be only at the discretion and close supervision of a healthcare professional, who should ensure the rational and responsible use of the medicine and considered benefits versus risks and review the patient to assess for effect, side-effects and the need to continue.
Danish: Ansøgeren bemærkede, at langvarig brug ud over den anbefalede tredages periode kun må finde sted efter en sundhedspersons skøn og under forudsætning af, at denne sundhedsperson fører tæt opsyn med patienten, sørger for rationel og ansvarlig brug af lægemidlet, overvejer fordele i forhold til risici og gennemgår patienten for at vurdere virkning, bivirkninger og behovet for at fortsætte.
English: Its objective was to compare timeadjusted Summed Pain Intensity Differences (SPIDs) from baseline of the Visual Analogue Pain (VAS) pain intensity scores up to 24 hours after the first dose of study medication among the four treatment groups to determine the form of the dose-response relationship.
Danish: Dens formål var at sammenligne de tidsjusterede Summed Pain Intensity Differences (SPID) af Visual Analog Pain (VAS) smerteintensitetsscore fra baseline op til 24 timer efter den første dosis forsøgsmedicin mellem de fire behandlingsgrupper for at fastlægge formen af dosis-respons-sammenhængen.
English: In the potential of medication without the supervision by healthcare potential additional risk minimisation measure would be the restriction of the pack size in order not to exceed the maximum daily recommended dose of 3000 / 900 mg paracetamol/ibuprofen (6 tablets) for maximal duration of three days.
Danish: Hvad angår potentialet for medicinering uden opsyn af sundhedspersoner ville en supplerende risikominimeringsforanstaltning være at begrænse pakningsstørrelsen for at undgå overskridelse af den maksimale daglige anbefalede dosis på 3 000/900 mg paracetamol/ibuprofen (6 tabletter) i højst tre dage.
English: Median time to perceptible pain relief was significantly shorter for the combination than ibuprofen and placebo (p<0.05) and non-significant for the comparison with paracetamol.
Danish: Mediantiden til mærkbar smertelindring var signifikant kortere for kombinationen end for ibuprofen og placebo (p <0,05) og ikke-signifikant for sammenligningen med paracetamol.
English: Overall, the data demonstrated that the use of the combination of paracetamol and ibuprofen at the given doses is safe and effective in the intended indication, duration of use and population, including the elderly.
Danish: Overordnet viste dataene, at anvendelsen af kombinationen af paracetamol og ibuprofen i de givne doser er sikker og effektiv til den påtænkte indikation, anvendelsesvarighed og patientgruppe, herunder ældre.
English: The results showed that the means of time-adjusted SPIDs in placebo group (mean=6.63, SD=19.79) is significantly lower than either the one of Combination ¼ dose group (mean=19.25, SD=19.99), the Combination ½ dose group (mean=20.44, standard deviation (SD=20.78) or the Combination full dose group (mean=20.12, SD=18.01).
Danish: Resultaterne viste, at den gennemsnitlige tidsjusterede SPID i placebogruppen (gennemsnit = 6,63, standardafvigelse = 19,79) er signifikant lavere end både i ¼-dosisgruppen med kombinationen (gennemsnit = 19,25, SD = 19,99), ½dosisgruppen med kombinationen (gennemsnit = 20,44, (standardafvigelse = 20,78) og fulddosisgruppen med kombinationen (gennemsnit = 20,12, standardafvigelse = 18,01).
English: The CHMP assessed the available data and the additional supportive data from literature to support the use of this combination in the short term treatment of pain.
Danish: CHMP vurderede de foreliggende data og de supplerende data fra litteraturen til støtte for anvendelsen af denne kombination til kortvarig smertebehandling.
English: The CHMP took these comments into account, and considered that with the additional amendments to the product information for the restriction of use to maxim of 3 days, and the additional data provided for special populations including the elderly, that the overall safety of this fixed-dese combination to be acceptable in the indication for the short-term symptomatic treatment of mild to moderate pain.
Danish: CHMP tog disse bemærkninger til efterretning og vurderede, at med de yderligere ændringer af produktinformationen, der begrænser brugen til maksimalt 3 dage, og de supplerende data vedrørende særlige populationer, herunder ældre, er den overordnede sikkerhed for denne fastdosiskombination acceptabel til indikationen kortvarig symptomatisk behandling af lette til moderate smerter.
English: The CHMP noted the concerns by these members, but agreed that overall the efficacy of the combination for the short duration of use of 3 days has been demonstrated.
Danish: CHMP noterede sig disse medlemmers betænkeligheder, men fandt, at virkningen af kombinationen ved den korte anvendelsestid på 3 dage overordnet var påvist.
English: Based on clinical data provided by the applicant, no new safety issues have been identified.
Danish: Der fremgår ingen nye sikkerhedsproblemer af de kliniske data, ansøgeren har forelagt.
English: Paracetamol and ibuprofen are two analgesic compounds with long histories of clinical use and both have been shown to be safe and well tolerated at maximum recommended daily doses.
Danish: Paracetamol og ibuprofen er to analgetiske forbindelser med lang tids klinisk anvendelse bag sig, og begge er påvist at være sikre og veltolererede ved de anbefalede maksimale daglige doser.
English: During the CHMP discussion, members expressed divergent views based mainly on the potential for increased risks of rare but severe adverse events due to overtreatment, uncertainty in some treatment populations, that the expected benefits are not considered sufficient to accept these increased risks and that no evidence was provided to support the need of this product or its first-line use.
Danish: Under drøftelserne i CHMP fremførte nogle medlemmer divergerende synspunkter, primært baseret på den mulige øgede risiko for sjældne, men svære bivirkninger som følge af overbehandling, usikkerheden vedrørende visse behandlingspopulationer, på, at de forventede fordele ikke anses for tilstrækkelige til at disse øgede risici kan godtages, og at der ikke er forelagt evidens for behovet for produktet eller dets anvendelse som førstevalgsbehandling.
English: This study is an acute pain study for mild-moderate pain since arthroscopy is a minor surgical procedure which results in little ongoing pain and in fact as discussed below pain dissipates rapidly.
Danish: Denne undersøgelse vedrører akutte lette til moderate smerter, da artroskopi er et mindre operativt indgreb, der kun medfører ringe vedvarende smerter og faktisk hurtigt svinder som beskrevet nedenfor.
English: During the review process the superior efficacy of the fixed dose combination were compared to each mono-component.
Danish: Under gennemgangsprocessen blev fastdosiskombinationens overlegne virkning sammenholdt med hver monokomponent.
English: Study AFT-MX-6E was a phase III trial in another acute pain model (arthroscopy).
Danish: Undersøgelse AFT-MX-6E var en fase III-undersøgelse med en anden model for akutte smerter (artroskopi).
English: This phase II exploratory study has shown that in osteoarthritis pain, the combination is effective.
Danish: Denne fase II-forundersøgelse har vist, at kombinationen er effektiv ved smerter forårsaget af osteoartritis.
English: Male and female participants aged 18 and 60 years undergoing surgical removal of least two impacted third molars were eligible for this study.
Danish: Undersøgelsen omfattede mænd og kvinder i alderen 18 til 60 år, der operativt fik fjernet mindst to impakterede tredjemolarer.
English: • 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.
Danish: • udvalget konkluderede ved en flertalsafgørelse, at benefit/risk-forholdet er positivt for dette lægemiddel til kortvarig symptomatisk behandling af lette til moderate smerter.
English: 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.
Danish: De vurderede sikkerhedsudfald var øvre gastrointestinale hændelser, myokardieinfarkt, apopleksi, nyresvigt (eksklusive kronisk), kongestivt hjertesvigt, forsætlig eller uforsætlig overdosering, suicidaladfærd og dødelighed.
English: The data obtained in AFT-MX-1 is reinforced by the large Phase III efficacy study AFT-MX-6.
Danish: Dataene fra AFT-MX-1 underbygges af den store fase III-undersøgelse af virkning AFT-MX-6.
English: This medicinal product is already authorised during the first and second waves of the decentralised procedure as prescription only medicine in many EU countries.
Danish: 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.
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The CHMP also recommended the short term use (max for 3 days) of this fixed dose combination.
Danish: CHMP anbefalede også korttidsanvendelse (højst tre dage) af denne fastdosiskombination.
English: 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.
Danish: 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.
English: The results showed that the combination of paracetamol and ibuprofen had greater analgesic efficacy than the same dose of ibuprofen alone.
Danish: Resultaterne viste, at kombinationen af paracetamol og ibuprofen havde større analgetisk virkning end samme dosis ibuprofen alene.
English: 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.
Danish: Derudover er sikkerhedsoplysningerne skærpet vedrørende særlige populationer, herunder ældre og patienter med nedsat lever- og nyrefunktion, så de afspejler advarslerne for anvendelse af enkeltkomponenterne,
English: 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.
Danish: De dosisstyrker, der anvendes i den påtænkte fastdosiskombination, ligger et godt stykke inden for det anbefalede dosisområde, især dosis af ibuprofen.
English: Rescue medication consumption was accounted for in the primary endpoint analysis by carrying forward the pre-rescue VAS pain score.
Danish: I den primære endepunktsanalyse blev der taget hensyn til forbruget af redningsmedicin ved at fremføre VAS-smertescore fra før redningsmedicinen.
English: The short term use (max for 3 days) of this fixed dose combination has been recommended by the CHMP and accepted by the applicant.
Danish: 3 dage) af denne fastdosiskombination anbefales af CHMP og er accepteret af ansøgeren.
English: 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.
Danish: 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.
English: The PSURs would undoubtedly cover a range of ages and uses based upon real in market experience.
Danish: PSUR'erne dækker utvivlsomt de faktiske erfaringer på markedet mht. alder og anvendelse.
English: 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.
Danish: 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.
English: 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.
Danish: Ansøgerens rationale, der beskrev behovet for fastdosiskombinationen til korttidsbehandling af akutte smerter, blev forelagt for CHMP.
English: 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.
Danish: 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.
English: The incidence of adverse events is as expected and most commonly involves the gastrointestinal tract.
Danish: Forekomsten af bivirkninger er som forventet og omfatter hovedsagelig mave-tarmkanalen.
English: In absence of this fixed dose combination the rescue remedy for the pain is resulting in use of opioids, instead.
Danish: I mangel af denne fastdosiskombination vil der som redningsmedicin ved smerter stedet blive anvendt opioider.
English: 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.
Danish: 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.
English: 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).
Danish: Kliniske undersøgelser med fastdosiskombinationen har heller ikke vist andre bivirkninger end dem, der kendes for paracetamol alene eller ibuprofen alene.
English: 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.
Danish: 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.