FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Article 31 pharmacovigilance referral for codeine used for management of pain in paediatric patients (EMA/H/A-31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f symptomatic treatment of cough and/or cold as current evidence does not find codeine to be more effective than placebo for acute cough in children.
Danish: 1 Artikel 31-indbringelse vedrørende lægemiddelovervågning for kodein til analgetisk behandling af børn (EMA/H/A31/1342) http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Codeinecontaining_medicines/human_referral_prac_000008.jsp&mid=WC0b01ac05805c516f
English: All codeine containing medicinal products approved for the treatment of cough and/or cold in paediatric population, including single and combination products authorised in the European Union are included in this review.
Danish: Gennemgangen omfatter alle kodeinholdige lægemidler, der er godkendt til behandling af hoste og eller forkølelse hos børn, herunder monokomponent- og kombinationsprodukter godkendt i EU.
English: • In addition, the PRAC considered that the current evidence suggests that children below 12 years are at special risk of life-threatening respiratory depression and therefore, concluded that the use of codeine containing medicinal products for the treatment of cough and/or cold is contraindicated in children below 12 years.
Danish: • PRAC fandt desuden, at den nuværende evidens viser, at børn under 12 år er særligt udsat for livstruende respirationsdepression, og konkluderede derfor, at kodeinholdige lægemidler til behandling af hoste og/eller forkølelse er kontraindiceret hos børn under 12 år.
English: • The PRAC considered available data on the safety and the efficacy of the codeine containing medicinal products for the treatment of cough and/or cold in children in relation to the risk of opioid toxicity.
Danish: • PRAC gennemgik de foreliggende data om sikkerheden og virkningen af kodeinholdige lægemidler til behandling af hoste og/eller forkølelse hos børn vedrørende risikoen for opioidtoksicitet.
English: This included contraindication in patients of any age known to be CYP2D6 ultra-rapid metabolisers and in women of all ages who are breastfeeding.
Danish: Hertil hører kontraindikation hos patienter, der uanset alder vides at være ultrahurtige CYP2D6-metabolisatorer, og hos kvinder uanset alder, som ammer.
English: The PRAC also considered that the use of codeine in pain relief could be associated with serious adverse events of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine, in particular in the paediatric population below 12 years of age and therefore codeine should not be used in this population.
Danish: PRAC fandt derudover, at analgetisk anvendelse af kodein kunne være forbundet med opioidtoksiske hændelser som følge af den variable og uforudsigelige metabolisering af kodein til morfin, navnlig hos børn under 12 år, og at kodein derfor ikke burde anvendes hos denne patientgruppe.
English: • The PRAC, in line with the restrictions introduced during the codeine referral for pain relief in children, also concluded that all codeine containing medicinal products for the treatment of cough and/or cold should be contraindicated in women when breastfeeding, as well as in patients known to be CYP2D6 ultra-rapid metabolisers.
Danish: • på linje med de begrænsninger, der blev indført under indbringelsen vedrørende analgetisk anvendelse af kodein hos børn, konkluderede PRAC desuden, at alle kodeinholdige lægemidler til behandling af hoste og/eller forkølelse bør være kontraindiceret hos kvinder, der ammer, og hos patienter, der vides at være ultrahurtige CYP2D6-metabolisatorer,
English: Based on all the above, the PRAC recommended restrictions of the use of codeine for cough and/or cold in the paediatric population.
Danish: På grundlag af alt det ovennævnte anbefalede PRAC begrænsninger for anvendelsen af kodein mod hoste og/eller forkølelse hos børn.
English: In addition, the CMDh considered that a minor change was necessary to the wording proposed in Sections 4.2 and 4.6 of the Summary of Product Characteristics (SmPC) and Section 2 of the Package Leaflet (PL), in order to facilitate the practical implementation at the National level, taking into account the range of combination products included in the procedure.
Danish: 4.2 og 4.6 i produktresuméet og af afsnit 2 i indlægssedlen for at lette den praktiske gennemførelse på nationalt plan med henblik på det antal kombinationsprodukter, der er omfattet af proceduren.
English: Similarly, it was not recommended to use codeine in children whose breathing could be compromised including children with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Danish: Tilsvarende blev anvendelse af kodein frarådet hos børn, hvis respiration kunne være nedsat, herunder børn med neuromuskulære lidelser, svære kardiale eller respiratoriske sygdomme, øvre luftvejs- eller lungeinfektioner, multiple traumer eller omfattende operative indgreb.
English: The PRAC also considered that the risk of accidental overdose (four cases identified) could be minimised by the use of child resistant containers (CRC).
Danish: PRAC fandt desuden, at risikoen for accidentel overdosering (4 tilfælde konstateret) kunne minimeres med børnesikret emballage.
English: Whereas EMs or UMs are at risk of morphine toxicity, PMs may be at an increased risk of a lack of therapeutic effect.
Danish: Mens ekstensive og ultrahurtige metabolisatorer har risiko for morfintoksicitet, kan dårlige metabolisatorer have øget risiko for manglende virkning.
English: The PRAC further concluded that codeine should be contraindicated in paediatric patients below 18 years of age undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome as well as in women during breast-feeding and in patients known to be CYP2D6 ultra-rapid metabolisers.
Danish: PRAC konkluderede endvidere, at kodein bør være kontraindiceret hos pædiatriske patienter under 18 år, som får foretaget tonsillektomi og/eller adenodektomi til behandling af obstruktivt søvnapnøsyndrom og hos kvinder under amning samt hos patienter, der vides at være ultrahurtige CYP2D6-metabolisatorer.
English: While acknowledging that uncertainties remain regarding the identification of particular paediatric populations at higher risk and the impact of age on codeine metabolism, the PRAC was of the opinion that neonates, toddlers and young children may be more vulnerable to opioid toxicity and therefore at special risk of life-threatening respiratory depression.
Danish: PRAC erkendte, at der tilbagestår usikkerhed om udpegelsen af bestemte pædiatriske populationer med øget risiko og om alderens betydning for metaboliseringen af kodein, men udvalget anså nyfødte, spædbørn og småbørn for at kunne være ekstra sårbare for opioidtoksicitet og derfor særlig udsat for livstruende respirationsdepression.
English: The CMDh, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and agreed that the marketing authorisation(s) for should be revoked or varied, as applicable.
Danish: Efter gennemgang af PRAC's anbefaling tilslutter CMDh sig PRAC's overordnede videnskabelige konklusioner og tilslutter sig, at markedsføringstilladelserne for lægemidler indeholdende kodein inddrages eller i givet fald ændres.
English: • The PRAC having reviewed the available evidence and in particular the risk of serious adverse reactions of opioid toxicity in children, the nature of the condition and the views of clinical experts considered that the use of codeine containing medicinal products for the treatment of cough and/or cold in the paediatric population is not recommended.
Danish: • efter gennemgang af den foreliggende evidens, navnlig risikoen for alvorlige bivirkninger som følge af opioidtoksiske reaktioner hos børn, sygdommens art og holdningen hos kliniske eksperter, fandt PRAC, at det bør frarådes at anvende kodeinholdige lægemidler til behandling af hoste og/eller forkølelse hos børn,
English: Therefore, consideration should be given at National level for this contraindication to be included in the labelling of codeine products approved only for adults via variation application submitted by the respective marketing authorisation holders.
Danish: For kodeinprodukter, der udelukkende er godkendt til voksne, bør det derfor på nationalt plan overvejes at tilføje denne kontraindikation gennem en ændringsansøgning, der indgives af de pågældende markedsføringstilladelsesindehavere.
English: The PRAC initiated a review of the benefit-risk balance of codeine in the treatment of cough and/or cold in paediatric patients.
Danish: PRAC indledte en gennemgang af benefit/risk-forholdet for kodein til behandling af hoste og/eller forkølelse hos børn.
English: Therefore, the PRAC recommends child resistant containers (CRC) for all oral liquid codeine containing medicinal products.
Danish: PRAC anbefaler derfor anvendelse af børnesikret emballage til alle flydende orale kodeinprodukter.
English: In total, fourteen reports of codeine intoxication in children related to the treatment of cough and respiratory infection were identified in the published literature.
Danish: I litteraturen er der i alt fundet 14 beskrivelser af kodein-intoksikation hos børn ved behandling af hoste og luftvejsinfektioner.
English: The PRAC further considered that in children aged 12 years to 18 years for whom respiratory function might be compromised including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures, codeine is not recommended as these conditions may worsen symptoms of morphine toxicity.
Danish: PRAC fandt desuden, at brug af kodein bør frarådes hos børn fra 12 til 18 år med kompromitteret respirationsfunktion som følge af neuromuskulære sygdomme, svær hjerte- eller luftvejssygdom, øvre luftvejs- eller lungeinfektion, multiple traumer eller omfattende kirurgiske indgreb, da disse tilstande kan forstærke symptomerne på morfintoksicitet.
English: The PRAC further considered that in children aged 12 years to 18 years with compromised respiratory function the use of codeine is not recommended.
Danish: PRAC fandt derudover, at det bør frarådes at anvende kodein hos børn fra 12 til 18 år med nedsat respirationsfunktion,
English: However, the CMDh considered that in view of the recommended contra indication of the use of codeine for cough and/or cold in children below 12 years of age, some marketing authorisations may have to be revoked.
Danish: CMDh fandt det imidlertid nødvendigt at inddrage visse markedsføringstilladelser på baggrund af den anbefalede kontraindikation af anvendelse af kodein mod hoste og/eller forkølelse hos børn under 12 år.
English: In addition, another randomised clinical trial (Taylor et al, 1993) in children with codeine, dextromethorphan as an active comparator, and a placebo group showed that neither codeine nor dextromethorphan were significantly better then placebo for the symptomatic treatment of cough in children under 12 years of age.
Danish: I en anden randomiseret klinisk undersøgelse hos børn (Taylor et al, 1993) blev kodein sammenlignet med dextromethorphan som aktivt sammenligningspræparat og med en placebogruppe.
English: In this regard the PRAC noted that all codeine containing products approved for adults regardless of the indication, should have these contraindications included in their labelling.
Danish: PRAC bemærkede, at disse kontraindikationer bør indføres i produktinformationen for alle kodeinholdige produkter, der er godkendt til voksne, uanset indikation.
English: Therefore, the PRAC recommended the variation to the terms of the marketing authorisation for medicinal products containing codeine for cough and/or cold in children referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Danish: konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende kodein til hoste og/eller forkølelse hos børn fortsat er positivt, forudsat at de vedtagne begrænsninger, advarsler og øvrige ændringer indsættes i produktinformationen, anbefaler PRAC ændring af markedsføringstilladelsen for de i bilag I omhandlede lægemidler indeholdende kodein mod hoste og/eller forkølelse hos børn, for hvilke de relevante afsnit af produktresuméet, og indlægssedlen fremgår af bilag III til PRAC's anbefaling.
English: However, there is little clinical data in the medical literature to support the efficacy of codeine in the
Danish: I litteraturen er der imidlertid kun få kliniske data til støtte for virkningen af kodein til symptomatisk behandling af hoste og/eller forkølelse, da kodein ifølge den nuværende evidens ikke er mere effektivt end placebo mod akut hoste hos børn.
English: The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Danish: Indehaveren af markedsføringstilladelsen forelægger fyldestgørende og tilfredsstillende oplysninger, der bekræfter lægemidlernes bioækvivalens med referencelægemidlet, inden for et år efter Europa-Kommissionens afgørelse.
English: Conditions for lifting the suspension of the Marketing Authorisations
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: Annex III Conditions for lifting the suspension of the Marketing Authorisations
Danish: Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: The National Competent Authorities of Member States shall ensure that the following conditions are fulfilled by the MAH:
Danish: De nationale kompetente myndigheder skal sikre, at følgende betingelser opfyldes af indehaveren af markedsføringstilladelsen:
English: Further information on Febuxostat Krka can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
Danish: Yderligere information vedrørende Febuxostat Krka findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
English: This usually reduces blood uric acid levels within 2 weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after 2 to 4 weeks.
Danish: Dette reducerer normalt blodets indhold af urinsyre inden for to uger, men dosen kan øges til 120 mg én gang dagligt, hvis blodets indhold af urinsyre forbliver højt (over 6 mg pr. deciliter) efter to til fire uger.
English: As for every medicine, the company provided studies on the quality of Febuxostat Krka.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Febuxostat Krka.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Krka.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Adenuric, og de behøver ikke at blive gentaget for Febuxostat Krka.
English: For more information about using Febuxostat Krka, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brugen af Febuxostat Krka, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Febuxostat Krka has been shown to have comparable quality and to be bioequivalent to Adenuric.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Febuxostat Krka er af sammenlignelig kvalitet og er bioækvivalent med Adenuric.
English: Side effects reported with Febuxostat Krka are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Febuxostat Krka vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Febuxostat Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Febuxostat Krka?
English: This can reduce the symptoms of gout.
Danish: Dette kan mindske symptomerne på urinsyregigtanfald.
English: This means that Febuxostat Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Adenuric.
Danish: Det betyder, at Febuxostat Krka indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Adenuric.
English: Febuxostat Krka should be started 2 days before chemotherapy and continued for at least 7 days.
Danish: Behandlingen med Febuxostat Krka bør påbegyndes to dage inden kemoterapien og fortsættes i mindst syv dage.
English: Febuxostat Krka is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Danish: Febuxostat Krka fås som tabletter (80 og 120 mg) og udleveres kun efter recept.
English: It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Danish: Det virker ved at blokere et enzym kaldet xanthinoxidase, som er nødvendigt for, at kroppen kan producere urinsyre.
English: An overview of Febuxostat Krka and why it is authorised in the EU
Danish: Oversigt over Febuxostat Krka og hvorfor det er godkendt i EU
English: In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Danish: Hos patienter i kemoterapi forventes en reduktion af urinsyreniveauet at mindske risikoen for tumorlysesyndrom.
English: Because Febuxostat Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Febuxostat Krka er et generisk lægemiddel, og er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefits and risks of Febuxostat Krka?
Danish: Hvilke fordele og risici er der forbundet med Febuxostat Krka?
English: Why is Febuxostat Krka authorised in the EU?
Danish: Hvorfor blev Febuxostat Krka godkendt i EU?
English: Febuxostat Krka contains the active substance febuxostat and is a ‘generic medicine'.
Danish: Febuxostat Krka indeholder det aktive stof febuxostat og er et "generisk lægemiddel".
English: What is Febuxostat Krka and what is it used for?
Danish: Hvad er Febuxostat Krka, og hvad anvendes det til?
English: Other information about Febuxostat Krka
Danish: Andre oplysninger om Febuxostat Krka
English: As for all medicines, data on the use of Febuxostat Krka are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Febuxostat Krka løbende overvåget.
English: By reducing the production of uric acid, Febuxostat Krka can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Danish: Ved at reducere produktionen af urinsyre kan Febuxostat Krka reducere niveauet af urinsyre i blodet og holde det lavt og derved standse opbygningen af krystaller.
English: For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Krka is 80 mg once a day.
Danish: Ved behandling af langvarig urinsyregigt er den anbefalede dosis af Febuxostat Krka 80 mg én gang dagligt.
English: Febuxostat Krka is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Danish: Febuxostat Krka anvendes til patienter, som har symptomer på opbygning af krystaller, herunder urinsyregigt (smerter og inflammation i leddene) eller tophi ("sten", større aflejringer af uratkrystaller, som kan medføre led- og knogleskader).
English: Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first 6 months of treatment with Febuxostat Krka.
Danish: Derfor anbefales det, at patienter tager andre lægemidler for at forebygge anfald af urinsyregigt i de første seks måneder af behandlingen med Febuxostat Krka.
English: Therefore, the Agency's view was that, as for Adenuric, the benefit of Febuxostat Krka outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene af Febuxostat Krka opvejer de identificerede risici, som for Adenuric, og det kan godkendes til anvendelse i EU.
English: Febuxostat Krka is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Danish: Febuxostat Krka anvendes også til behandling og forebyggelse af et højt indhold af urinsyre i blodet hos voksne med blodkræft, der er i kemoterapi (lægemidler til behandling af kræft), og som er i risikogruppen for at udvikle tumorlysesyndrom (en komplikation som følge af nedbrydningen af kræftceller, der skaber en pludselig forhøjelse af urinsyreindholdet i blodet, som kan beskadige nyrerne).
English: Febuxostat Krka is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Danish: Febuxostat Krka er et lægemiddel, der anvendes til behandling af voksne med langvarig urinsyregigt (et højt indhold af urinsyre eller "urat" i blodet).
English: Febuxostat Krka treatment should not be stopped if an attack of gout occurs.
Danish: Behandlingen med Febuxostat Krka skal ikke afbrydes, hvis der kommer et urinsyregigtanfald.
English: The active substance in Febuxostat Krka, febuxostat, reduces the formation of uric acid.
Danish: Det aktive stof i Febuxostat Krka, febuxostat, reducerer dannelsen af urinsyre.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Krka have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Febuxostat Krka.
English: How is Febuxostat Krka used?
Danish: Hvordan anvendes Febuxostat Krka?
English: How has Febuxostat Krka been studied?
Danish: Hvordan blev Febuxostat Krka undersøgt?
English: This may cause allergic reactions.
Danish: Det kan forårsage allergiske reaktioner.
English: Take the next dose at the usual time.
Danish: Tag næste dosis til sædvanlig tid.
English: The registry should also be used to generate data on long-term effectiveness.
Danish: Registeret skal desuden anvendes til at tilvejebringe data om den langsigtede effektivitet.
English: When needed, supportive symptomatic treatment should be given.
Danish: Ved behov gives støttende symptomatisk behandling.
English: Patients should be regularly monitored according to local clinical practice.
Danish: Patienterne bør overvåges regelmæssigt i henhold til lokal klinisk praksis.
English: Date of first authorisation: 8 September 2015
Danish: Dato for første markedsføringstilladelse: 8. september 2015
English: The following side effect may happen with this medicine:
Danish: Følgende bivirkninger kan forekomme med dette lægemiddel: