natgillin/translations-raw huggingface dataset:
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. 
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.
Med fastdosiskombinationen undgås behovet for at skifte til opioider med konsekvenser heraf i form af sikkerheds- og afhængighedsrisici. 
The fixed dose combination avoids the need to move to opioids with all their implications regarding safety and addiction risks.
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. 
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.
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. 
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.
Da den påtænkte fastdosiskombination frarådes anvendt i mere end 3 dage, reduceres potentialet for langvarig anvendelse væsentligt. 
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.
For denne stofkombination er der desuden ingen interferens med hvert af stoffernes metaboliseringsvej, og deres farmakologiske virkningsmekanisme er forskellig. 
Furthermore, for this substance combination, there is no interference with their individual metabolic pathways, and they also act through different pharmacological pathways.
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. 
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.
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. 
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.
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. 
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.
Mediantiden til mærkbar smertelindring var signifikant kortere for kombinationen end for ibuprofen og placebo (p <0,05) og ikke-signifikant for sammenligningen med paracetamol. 
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.
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. 
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.
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). 
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).
CHMP vurderede de foreliggende data og de supplerende data fra litteraturen til støtte for anvendelsen af denne kombination til kortvarig smertebehandling. 
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.
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. 
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.
CHMP noterede sig disse medlemmers betænkeligheder, men fandt, at virkningen af kombinationen ved den korte anvendelsestid på 3 dage overordnet var påvist. 
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.
Der fremgår ingen nye sikkerhedsproblemer af de kliniske data, ansøgeren har forelagt. 
Based on clinical data provided by the applicant, no new safety issues have been identified.
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. 
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.
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. 
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.
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. 
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.
Under gennemgangsprocessen blev fastdosiskombinationens overlegne virkning sammenholdt med hver monokomponent. 
During the review process the superior efficacy of the fixed dose combination were compared to each mono-component.
Undersøgelse AFT-MX-6E var en fase III-undersøgelse med en anden model for akutte smerter (artroskopi). 
Study AFT-MX-6E was a phase III trial in another acute pain model (arthroscopy).
Denne fase II-forundersøgelse har vist, at kombinationen er effektiv ved smerter forårsaget af osteoartritis. 
This phase II exploratory study has shown that in osteoarthritis pain, the combination is effective.
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.