natgillin/translations-raw huggingface dataset:
CHMP konkluderede imidlertid, at Cyanokit havde fordele frem for alternative modgifte, fordi det har en god sikkerhedsprofil hos patienter, der ikke er forgiftet.
However, the CHMP concluded that Cyanokit had advantages over alternative antidotes because it has a good safety profile in patients who have not been poisoned.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cyanokit, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cyanokit, including the appropriate precautions to be followed by healthcare professionals and patients.
Der er ikke udført undersøgelser, der direkte sammenligner Cyanokit med andre lægemidler hos mennesker.
There have been no studies directly comparing Cyanokit to any other treatment in humans.
Det aktive stof i Cyanokit, hydroxocobalamin, reagerer med cyanid i kroppen, hvorved der dannes cyanocobalamin, en ugiftig forbindelse, der udskilles af kroppen gennem urinen.
The active substance in Cyanokit, hydroxocobalamin, reacts with cyanide in the body to form cyanocobalamin, a non-poisonous compound that is removed from the body in the urine.
Hyppigheden af de øvrige bivirkninger af Cyanokit kan ikke vurderes ud fra de foreliggende oplysninger.
The frequency of the other side effects of Cyanokit cannot be estimated with the information currently available.
To patienter overlevede, skønt de fik hjertestop, før de fik Cyanokit.
Two patients survived despite their hearts having stopped before receiving Cyanokit.
Cyanokit gives sammen med anden passende sanerende og støttende behandling, herunder ilt til indånding.
Cyanokit is given along with other appropriate decontamination and supportive measures, including providing oxygen for the patient to breathe.
Det kan derfor være nyttigt, når der kun er mistanke om cyanidforgiftning.
This makes it a useful option when cyanide poisoning is only suspected.
Én undersøgelse omfattede 69 patienter med cyanidforgiftning som følge af udsættelse for røg fra ildebrande.
In one study of 69 patients, cyanide poisoning was due to exposure to smoke from fire.
Cyanidforgiftning skyldes sædvanligvis udsættelse for røg ved ildebrand, indånding eller indtagelse af cyanid eller optagelse af cyanid fra huden eller slimhinderne (f.eks. i munden).
Cyanide poisoning usually results from exposure to smoke from fire, from breathing or swallowing cyanide, or from getting it onto the skin or mucous membranes (moist body surfaces, such as the lining of the mouth).
Hvilken risiko er der forbundet med Cyanokit?
What is the risk associated with Cyanokit?
Oplysningerne om virkningen af Cyanokit blev hentet fra 83 patienter, der var indlagt på mistanke om cyanidforgiftning, og som fik Cyanokit.
Information on its effectiveness was obtained in 83 patients who had been admitted to hospital with suspected cyanide poisoning and who received Cyanokit.
Af de 14 patienter med cyanidforgiftning af anden årsag end indånding af røg overlevede de 10, af hvilke syv havde "dødelige" koncentrationer af cyanid i blodet.
Of the 14 patients whose cyanide exposure was due to something other than smoke inhalation, 10 survived, including seven patients with ‘lethal' levels of cyanide in the blood.
Derfor besluttede CHMP, at fordelene ved Cyanokit opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Cyanokit.
Therefore, the CHMP decided that Cyanokit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Dette mindsker cyanidindholdet i kroppen og standser bindingen af cyanid til enzymet cytokromoxidase, der findes i cellerne og er vigtigt for deres energiproduktion.
This lowers cyanide levels in the body and stops the cyanide fixing itself to an enzyme in cells called cytochrome oxidase, which is important for providing energy in cells.
Overlevelsesprocenten var størst hos dem, der fik Cyanokit, før de fik hjertestop, dem, der havde mindre svære symptomer på hjerneskade, og dem med lavere cyanidindhold i blodet.
Survival was more likely in those who received Cyanokit before their hearts had stopped, who had less severe symptoms of brain damage and who had lower blood cyanide levels.
Når en patient har fået Cyanokit, kan det gribe ind i vurderingen af eventuelle forbrændinger og i resultaterne af patientens laboratorieprøver.
The use of Cyanokit can interfere with the assessment of burns and with laboratory test results.
Hvorfor blev Cyanokit godkendt?
Why has Cyanokit been approved?
De fire, der døde, havde et højt cyanidindhold i blodet og fik enten hjertestop eller vejrtrækningsstop, før de fik Cyanokit.
The four who died had high blood levels of cyanide, and either their hearts had stopped or they had stopped breathing before receiving Cyanokit.
Cyanokit er et pulver, der opløses og indgives ved infusion (dråbetilførsel) i en vene.
Cyanokit is a powder to be made up into a solution for infusion (drip) into a vein.
Hvad er Cyanokit?
What is Cyanokit?
Cyanokit anvendes som modgift ved kendt eller formodet cyanidforgiftning.
Cyanokit is used as an antidote to treat known or suspected poisoning with cyanide, a highly poisonous chemical.
Den fuldstændige liste over de indberettede bivirkninger ved Cyanokit fremgår af indlægssedlen.
For the full list of all side effects reported with Cyanokit, see the package leaflet.
Med hver pakning af Cyanokit følger en klæbemærkat, der oplyser herom.
A sticker explaining this is supplied with every pack of Cyanokit.
Hvad anvendes Cyanokit til?
What is Cyanokit used for?
Hvordan blev Cyanokit undersøgt?
How has Cyanokit been studied?
Hvilken fordel viser undersøgelserne, at der er ved Cyanokit?
What benefit has Cyanokit shown during the studies?
Der foreligger ikke oplysninger om succesraten med andre modgifte til anvendelse ved cyanidforgiftning.
There is no information available on success rates with other antidotes for cyanide poisoning, so it was not possible to carry out a comparison between the success rates seen with Cyanokit and with alternatives.
Hvordan anvendes Cyanokit?
How is Cyanokit used?
Derudover undersøgtes 14 patienter med cyanidforgiftning af anden årsag end indånding af røg.
A further 14 patients were studied whose cyanide poisoning was due to something other than smoke inhalation; most of these patients had taken cyanide during a suicide attempt.
Hvordan virker Cyanokit?
How does Cyanokit work?
(se bilag I).
(see Annex I).
Der er forelagt en risikohåndteringsplan i overensstemmelse med ovenstående.
A risk management plan has been submitted in line with the above.
CHMP tog disse bemærkninger til efterretning.
The CHMP took these comments into account.
Ansøgeren forelagde strategien for litteratursøgning.
The applicant presented literature search strategy.
Referencemedlemsstaten (RMS) er Det Forenede Kongerige, og de berørte medlemsstater er Østrig (AT), Tyskland (DE), Kroatien (HR), Irland (IE), Luxembourg (LU), Frankrig (FR), Belgien (BE), Holland (NL), Portugal (PT) og Spanien (ES).
The reference Member State (RMS) is the United Kingdom and the concerned Member States (CMS) Austria (AT), Germany (DE), Croatia (HR), Ireland (IE), Luxembourg (LU), France (FR), Belgium (BE), Netherlands (NL), Portugal (PT) and Spain (ES).
De sekundære analyser viste enten ingen forskel eller var til fordel for kombinationen.
The secondary analyses showed either no difference or in favour of the combination.
Følgende hovedundersøgelser blev forelagt af ansøgeren til støtte for ansøgningen om markedsføringstilladelse.
The following main studies were submitted by the applicant in support of the marketing authorisation application.
Ibuprofen er det sikreste NSAID og er derfor et optimalt valg.
Ibuprofen is the safest of the NSAIDs and is therefore an optimal choice.
De decentrale procedurer UK/H /6034/001/DC, UK/H/6035/001/DC og UK/H/6176/001/DC blev indledt den 23. juli 2015.
The decentralised procedures UK/H/6034/001/DC, UK/H/6035/001/DC and UK/H/6176/001/DC started on 23 July 2015.
Da der ikke kunne opnås enighed ved CMDh-proceduren, blev proceduren indbragt for CHMP.
As at the CMDh procedure no agreement could be reached the procedure was referred to the CHMP.
Numerisk synes de alle at svare til hinanden; der er imidlertid ikke foretaget en formel sammenligning mellem de aktive stoffer.
They all seem numerically similar to each other; however no formal comparison between the active substances was performed.
Det bemærkes, at der er et betydeligt forbrug af kombinerede opioidpræparater i EU.
It is noted that there is significant use of opioid combinations in the EU.
Vigtigere er, at dette stemmer overens med erfaringerne efter markedsføring med anvendelsen af kombinationen både på verdensbasis og i EU-landene.
More importantly this is consistent with the post marketing experience of the use of the combination both world-wide and in the countries within the EU.
Det bør bemærkes, at den ansøgte indikation er til korttidseksponering (3 dage).
It is worth noting that the indication being sought is for short term (3 days) exposure.
Anvendelse af den faste kombination vil give både patienter og læger tid, før der anvendes et opioidholdigt produkt
The use of the fixed combination will give time to both patients and physicians before an opioid containing product will be used.
Risikostyring
Risk management
For moderate smerter er fordelene ved den relativt lille mængde ibuprofen heller ikke fyldestgørende påvist.
For moderate pain, the benefits of the relatively small amount of ibuprofen were also not robustly shown.
Navnlig medfører kombinationen ikke risiko for misbrug eller forkert brug af opioider.
In particular, the combination does not have the risks of abuse and misuse of opioids.
De omfattende erfaringer efter markedsføring i lande uden for EU tyder på, at potentialet for langvarig anvendelse næppe vil blive realiseret.
The extensive post-marketing experience in countries outside EU indicates the potential for prolonged use is unlikely to materialise.
Disse risici er velkendte og kontrolleres gennem rutinemæssig lægemiddelovervågning, som er godkendt af CHMP.
These risks are well known and are controlled by routine pharmacovigilance practices which CHMP has endorsed.
• udvalget behandlede anmeldelsen af den indbringelse, som er indledt af Det Forenede Kongerige i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF på grundlag af, at Frankrig, Tyskland, Spanien og Nederlandene fandt, at udstedelse af markedsføringstilladelsen ville udgøre en potentiel alvorlig risiko for den offentlige sundhed,
• The Committee considered the notification of the referral initiated by the United Kingdom under Article 29(4) of Directive 2001/83/EC on the basis that France, Germany, Spain and The Netherlands considered that the granting of the marketing authorisation would constitute a potential serious risk to public health.
Alle risici ved langvarig brug er i den gældende risikostyringsplan fremhævet som sikkerhedsproblemer.
All the risks associated with prolonged use have been identified as safety concerns in the current risk management plan.
Dette er vigtigt, da der er stigende betænkelighed ved sikkerhedsproblemerne knyttet til opioider såsom kodein, der anvendes som tillæg til paracetamol.
This is significant as there are growing concerns relating to the safety issues associated with opioids such as codeine when used in addition to paracetamol.
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.
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.
Ansøgeren bemærkede desuden, at PSURrapporter, der omfatter over 89 millioner tabletter anvendt på markedet, ikke har tydet på yderligere eller uventede risici.
The applicant noted also the PSUR reports which cover over 89 million tablets of market use have not suggested any additional or unexpected risks.
Det primære mål påviste, at kombinationen var statistisk overlegen i forhold til de aktive stoffer hver for sig.
The primary objective showed that the combination was statistically superior to the active substances individually.
For det tredje er der et medicinsk behov for en ny analgetisk fastdosiskombination uden opioidkomponent til lindring af akutte smerter.
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.
Dette potentiale er derfor så godt som uden betydning for status af lægemidlets benefit/risk-forhold.
Therefore such a potential has virtually no impact on the benefit-risk status of the medicinal product.
Det primære endepunkt for virkningen var den tidsjusterede sum af forskellene i smerteintensitet i forhold til baseline i løbet af 48 timer.
The primary efficacy endpoint was the time-adjusted sum of pain intensity differences from baseline over a 48 hour period.
Intermitterende manglende værdier blev estimeret ved lineær interpolation.
Linear interpolation was use to estimate intermittent missing values.
Undersøgelsen viste, at alle de aktive stoffer var statistisk overlegne i forhold til placebo.
In the study the active substances have all been shown to be statistically superior to placebo.
Resultaterne fra AFT-MX-6 er i overensstemmelse med AFT-MX-1, hvilket reelt yderligere styrker validiteten af resultaterne af AFT-MX-1.
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.
Resultaterne viste, at kombinationen medførte signifikant større smertelindring end nogen af enkeltkomponenterne (p <0,001).
The results showed that the combination provided significantly greater pain relief than either mono-component (p<0.001).
Efter at have taget alle de af ansøgeren forelagte data i betragtning vurderede CHMP, at benefit/risk-forholdet var tilfredsstillende godtgjort.
Having considered all the data submitted by the applicant, the CHMP considered that the benefit-risk balance was adequately demonstrated.
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.
Firstly, the two active substances in this fixed dose combination are supported by extensive published and regulatory evidence and history of efficacy and safety.
Rationalet for kombinationsforholdet i fastdosiskombinationen
Rationale for use of the fixed dose combination ratio
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.