FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the CHMP endorsed that the use OXN PR as a prolonged-release formulation of oxycodone and naloxone reduces the risk of abuse or misuse.
Danish: CHMP tilsluttede sig derfor, at anvendelse af OXN PR som depotformulering af oxycodon og naloxon mindsker risikoen for misbrug og forkert brug.
English: OXN PR is currently indicated in “severe pain, which can be adequately managed only with opioid analgesics”.
Danish: OXN PR er på nuværende tidspunkt godkendt til »stærke smerter, der kun kan behandles sufficient med opioidanalgetika«.
English: • The Committee considered that the amendments to the product information are appropriate to mitigate the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance and psychological dependence.
Danish: • udvalget fandt ændringerne i produktinformationen fyldestgørende til at afbøde risiciene for iatrogen lægemiddelafhængighed, misbrug eller forkert brug, dosisøgning, tolerans og psykisk afhængighed.
English: The frequency of adverse events and related adverse events was mostly comparable for both study phases (OXN3502/S) and points to a better tolerability of OXN PR in the extension phase.
Danish: Hyppigheden af bivirkninger og relaterede bivirkninger var i hovedsagen sammenlignelig for de to faser af undersøgelsen (OXN3502/S) og tyder på bedre tolerabilitet af OXN PR i forlængelsesfasen.
English: In addition, further improvements in the patient's condition by the end of the extension phase compared to the end of the double-blind phase was observed in the secondary efficacy parameters, including reduction in the severity of illness, improvements in sleep, RLS related pain and quality of life, respectively.
Danish: Desuden var patienternes tilstand yderligere forbedret ved slutningen af forlængelsesfasen i forhold til slutningen af den dobbeltblinde fase, hvad angår de sekundære virkningsparametre reduktion af sygdommens sværhed, forbedret søvn, RLS-relaterede smerter og livskvalitet.
English: The CHMP noted that the mean daily dose of OXN PR used in the extension phase was almost identical (and even slightly lower) compared to the mean daily dose used in the double-blind phase (18.12 mg vs. 22.62 mg), with no difference in mean doses in the extension phase between the subgroups previously treated with OXN PR or placebo.
Danish: CHMP bemærkede, at den gennemsnitlige dagsdosis af OXN PR i forlængelsesfasen var næsten identisk med (og endda lidt lavere end) den gennemsnitlige dagsdosis i den dobbeltblinde fase (18,12 mg mod 22,62 mg), og at der i forlængelsesfasen ikke var forskel i gennemsnitsdosis mellem de undergrupper, der forinden var behandlet med OXN PR eller placebo.
English: Even using a very conservative statistical approach, the magnitude of effect (decrease in mean IRLS of 5.9 points compared to placebo) was in line with or even slightly better than the results found in the placebo-controlled studies with dopamine agonists approved as first line treatment.
Danish: Selv med en meget forsigtig statistisk tilgang svarede virkningen (et fald i gennemsnitlig IRLS på 5,9 points i forhold til placebo) til resultaterne af placebokontrollerede undersøgelser med dopaminagonister, der er godkendt som førstevalgsbehandling.
English: The safety profile was also considered to be in-line with the experience of OXN PR used for the treatment of pain where adverse events are also more frequently reported at the beginning of therapy.
Danish: Sikkerhedsprofilen blev ligeledes anset for at være i overensstemmelse med erfaringerne med OXN PR til smertebehandling, hvor der også oftere indberettedes bivirkninger ved behandlingens begyndelse.
English: The review of ‘opioid dependence' revealed that during the extension phase two reports of withdrawal symptoms were obtained as part of the standard adverse event reporting procedures.
Danish: Gennemgangen af »opioidafhængighed« viste, at der i forlængelsesfasen blev indgivet to indberetninger om abstinenssymptomer som led i den rutinemæssige bivirkningsindberetning.
English: In addition, the CHMP highlighted the unmet medical need in the treatment of severe to very severe RLS.
Danish: Desuden understregede CHMP det uopfyldte behandlingsbehov ved svært til meget svært RLS.
English: The CHMP also took note of the risks of iatrogenic drug dependence, drug abuse or misuse, augmentation, tolerance, and psychological dependence associated with Oxynal and Targin and associated names.
Danish: CHMP noterede sig desuden de risici for iatrogen lægemiddelafhængighed, misbrug eller forkert brug, dosisforøgelse, tolerans og psykisk afhængighed, der er knyttet til Oxynal og Targin og relaterede navne.
English: A drug utilisation study will also be conducted to further characterise a possible risk of tolerance, dependence and drug abuse in long-term use in idiopathic restless leg syndrome.
Danish: Der skal desuden gennemføres en undersøgelse af lægemiddelanvendelse til yderligere karakterisering af eventuel risiko for tolerans, afhængighed og misbrug under langsigtet anvendelse ved restless legs syndrom,
English: The RLS treatment with OXN PR should be supervised by a clinician with experience in the management of IRLS.
Danish: Behandling af RLS med OXN PR bør ske under opsyn af en kliniker med erfaring i behandling af IRLS.
English: No case of augmentation, tolerance, psychological dependence (addiction), abuse or misuse was reported in the studies OXN3502/S.
Danish: Der blev ikke rapporteret dosisforøgelse, tolerans, psykisk afhængighed, misbrug eller forkert brug i undersøgelserne OXN3502/S.
English: There were no notable differences in the frequency of adverse events, severe adverse events and serious adverse events (overall and treatment-related) for young vs. elderly subjects as well as for females vs. males.
Danish: Der var ingen nævneværdige forskelle i hyppigheden af bivirkninger, svære bivirkninger og alvorlige bivirkninger (totale og behandlingsrelaterede) hos hhv. unge og ældre personer eller mellem kvinder og mænd.
English: No convincing scientific evidence has been provided in the perspective of public health that the benefit of the fixed dose combination of oxycodone/naloxone in the treatment of idiopathic restless leg syndrome (IRLS) outweighs the expected adverse effects that are associated with the use of strongopioids in doses equipotent to doses up to 90 mg of oral morphine; dependence, withdrawal, augmentation, misuse and abuse.
Danish: Der er ikke forelagt overbevisende videnskabelig evidens for, at den faste kombination af oxycodon/naloxon til behandling af idiopatisk restless leg syndrom (IRLS) giver fordele, der fra et sundhedsmæssigt synspunkt opvejer de forventede bivirkninger af stærke opioider i doser, der er ækvipotente med op til 90 mg oralt morfin: afhængighed, abstinenser, dosisstigning, forkert brug og misbrug.
English: Compared to other opioids, a lower potential for psychological dependence and abuse is further expected with OXN PR, as it is a prolonged release formulation whereas it is currently accepted knowledge that the risk of psychological dependence increases with faster drug release.
Danish: I forhold til andre opioider forventes der desuden at være lavere potentiale for psykisk afhængighed og misbrug med OXN PR, eftersom det er en depotformulering, og det er anerkendt, at risikoen for psykisk afhængighed stiger ved hurtigere frigivelse af lægemidlet.
English: Based on clinical experience and clinical guidance, the potential abuse and misuse of opioid analgesics in the controlled pain therapy is considered low.
Danish: Ud fra de kliniske erfaringer og kliniske vejledninger findes der kun at være ringe potentiale for misbrug og forkert brug af opioidanalgetika til kontrolleret smertebehandling.
English: Therefore, the Committee recommended the granting of the variation to the terms of the marketing authorisations for the medicinal products referred to in Annex I, for which the valid summary of product characteristics, labelling and package leaflets remain as per the final versions achieved during the Coordination group procedure with amendments as mentioned in Annex III.
Danish: anbefalede CHMP godkendelse af ændring af betingelserne for markedsføringstilladelserne for de i bilag I anførte lægemidler, for hvilke det gældende produktresumé og den gældende etikettering og indlægsseddel fortsat er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III.
English: Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.
Danish: 1 Walters AS et al. Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.
English: The CHMP agreed that the risk of physical dependence and associated withdrawal reaction can be mitigated and adequately managed by the strengthened tapering advice proposed.
Danish: CHMP fandt, at risikoen for fysisk afhængighed og den tilknyttede abstinensreaktion kan afhjælpes og behandles tilstrækkeligt med de foreslåede skærpede anvisninger for nedtrapning.
English: Further caution is included in the section 4.4 of the SmPC when OXN PR is administered to elderly irrespective of the indication.
Danish: I punkt 4.4 i produktresuméet er indsat yderligere forsigtighedsregler for anvendelse af OXN PR hos ældre uanset indikation.
English: Treatment with OXN PR in RLS has been contraindicated in patients with a history of opioid abuse.
Danish: Behandling med OXN PR ved RLS er blevet gjort kontraindiceret hos patienter med opioidmisbrug i anamnesen.
English: Therefore, short term efficacy of OXN PR as second line treatment of severe to very severe RLS after failure of dopaminergic treatment has convincingly been shown in the pivotal study OXN3502.
Danish: Den kortsigtede virkning af OXN som andetvalgsbehandling af svært til meget svært RLS efter svigt af dopaminerge lægemidler er derfor overbevisende påvist i hovedundersøgelsen OXN3502.
English: The mean ILRS score at the end of the open extension study was 9.72 and corresponds to a mild symptom severity.
Danish: Ved slutningen af den åbne forlængelsesundersøgelse var den gennemsnitlige ILRS-score 9,72 svarende til lette symptomer.
English: Furthermore, the risk of parenteral or intranasal misuse of OXN PR by individuals dependent on opioid agonists is expected to be low as marked withdrawal symptoms are expected due to the opioid receptor antagonist characteristics of naloxone.
Danish: Desuden antages der at være ringe risiko for parenteralt eller intranasalt misbrug af OXN hos personer, der er afhængige af opioidagonister, da der forventes markante abstinenssymptomer som følge af naloxons egenskaber som opioidreceptorantagonist.
English: In order to demonstrate the efficacy and safety of OXN PR in the symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy, the application dossier was based on a pivotal phase III clinical study (No OXN 3502) and open label extension study phase (No OXN 3502S).
Danish: Virkningen og sikkerheden af OXN PR til symptomatisk behandling af moderat til svært idiopatisk restless legs syndrom, som ikke har kunnet behandles sufficient med dopaminerge midler, var i ansøgningsdossieret baseret på en klinisk fase III-hovedundersøgelse (OXN 3502) og dennes åbne forlængelsesfase (OXN 3502S).
English: During the CMD(h) referral procedure, the proposed restless legs syndrome indication was restricted to “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy".
Danish: Under indbringelsesproceduren i CMD(h) blev den ansøgte indikation, restless legs syndrom, begrænset til »andetvalgs symptomatisk behandling af svært til meget svært idiopatisk restless legs syndrom efter svigt af dopaminerge lægemidler«.
English: On 31 August 2012, the MAH submitted a type II variation via the mutual recognition procedure (MRP) for Oxynal and Targin and associated names, to request the inclusion of “symptomatic treatment of patients with moderate to severe idiopathic restless legs syndrome insufficiently treated with dopaminergic therapy”.
Danish: Den 31. august 2012 indgav indehaveren af markedsføringstilladelsen via den gensidige anerkendelsesprocedure en type II-ændringsansøgning for Oxynal og Targin og relaterede navne med henblik på tilføjelse af »symptomatisk behandling af moderat til svært idiopatisk restless legs syndrom, der ikke kan behandles sufficient med dopaminerge lægemidler«.
English: • The Committee considered that the data of the pivotal phase III study and extension phase part are supportive of short term and long term efficacy of Oxynal and Targin and associated names in the second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Danish: • udvalget fandt, at dataene fra fase III-hovedundersøgelsen og forlængelsesdelen underbygger den kortsigtede og langsigtede virkning af Oxynal og Targin og relaterede navne til andetvalgs symptomatisk behandling af patienter med svært til meget svært idiopatisk restless legs syndrom efter svigt af dopaminerge lægemidler,
English: Warning regarding somnolence/sleep attacks and ability to drive/operating machinery has been added to the product information in accordance with the information given in the respective product information of dopaminergic substances approved in the RLS indication.
Danish: Dette er i overensstemmelse med oplysningerne i de respektive produktinformationer for dopaminerge stoffer godkendt til indikationen RLS.
English: • The Committee reviewed all available data in support of the safety and efficacy of Oxynal and Targin and associated names in “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy”.
Danish: • udvalget gennemgik alle foreliggende data, der underbygger sikkerheden og virkningen af Oxynal og Targin og relaterede navne til »andetvalgs symptomatisk behandling af patienter med svært til meget svært idiopatisk restless legs syndrom efter svigt af dopaminerge lægemidler«.
English: The CHMP considered that the data provided by the MAH are sufficient to support the use of Oxynal and Targin and associated names in the second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.
Danish: CHMP fandt de af markedsføringstilladelsesindehaveren forelagte data tilstrækkelige som grundlag for anvendelse af Oxynal og Targin og relaterede navne til andetvalgs symptomatisk behandling af patienter med svært til meget svært idiopatisk restless legs syndrom efter svigt af dopaminerge lægemidler.
English: As requested during the CMDh procedure, the applicant has further made a commitment to perform a drug utilisation study (DUS) and to update the risk management plan (RMP) subsequently to approval of the DUS in order to address concerns based on uncertainties that data of the clinical study including the long-term extension might not fully characterise a possible risk of tolerance, dependence and drug abuse in long-term use in IRLS.
Danish: Som anmodet under behandlingen i CMD(h) har ansøgeren desuden påtaget sig at gennemføre en undersøgelse af lægemiddelanvendelse (DUS) og efter godkendelse af DUS ajourføre risikohåndteringsplanen (RMP).
English: • The Committee concluded, in view of available data, that the benefit risk of Oxynal and Targin and associated names for “second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy” is positive.
Danish: • udvalget konkluderede på baggrund af de foreliggende data, at benefit/risk-forholdet er positivt for Oxynal og Targin og relaterede navne til »andetvalgs symptomatisk behandling af patienter med svært til meget svært idiopatisk restless legs syndrom efter svigt af dopaminerge lægemidler«,
English: The CHMP is of the opinion that the mean daily dose of 20mg/10mg oxycodone hydrochloride/naloxone used in the pivotal trial and being considerably lower than the doses needed in the pain indication should be mentioned in the SmPC to guide dosing.
Danish: For yderligere at øge sikkerheden og korrekt anvendelse af OXN PR til IRLS-indikationen er den maksimale daglige dosis blevet begrænset til 60 mg. CHMP er den opfattelse, at produktresuméet som vejledning for doseringen bør angive den gennemsnitlige daglige dosis på 20 mg/10 mg oxycodonhydrochlorid/naloxon, der er anvendt i hovedundersøgelsen og er væsentligt lavere end de nødvendige doser til smerteindikationen.
English: Keep container tightly closed.
Danish: Hold beholderen tæt tillukket.
English: The absolute bioavailability is approximately 20%.
Danish: Den absolutte biotilgængelighed er ca. 20%.
English: Such factors include:
Danish: Disse faktorer kan være:
English: Not all pack sizes may be marketed.
Danish: Det er ikke alle pakningstørrelser, som er markedsført.
English: In such situations, appropriate monitoring of INR is desirable.
Danish: I sådanne situationer bør passende monitorering af INR foranstaltes.
English: The maximum response is usually achieved by 4 weeks and is maintained after that.
Danish: Maksimum respons opnås normalt på 4 uger og opretholdes derefter.
English: This small increase is not considered clinically significant.
Danish: Denne lille stigning anses ikke klinisk relevant.
English: asymptomatic and transient.
Danish: asymptomatiske og forbigående.
English: Liver function and CK levels should be monitored.
Danish: Leverfunktion og CK niveauer bør monitoreres.
English: Crestor may be given at any time of day, with or without food.
Danish: Crestor kan gives på et hvilket som helst tidspunkt af døgnet med eller uden føde.
English: Safety and efficacy have not been established in children.
Danish: Effekt og sikkerhed er ikke fastlagt hos børn.
English: LU1 3LU England UK
Danish: LU1 3LU England Det Forenede Kongerige
English: A therapeutic effect is obtained within 1 week following treatment initiation and 90% of maximum response is achieved in 2 weeks.
Danish: Terapeutisk effekt opnås indenfor 1 uge efter behandlingens start og 90 % af maksimum respons opnås på 2 uger.
English: No other dose adjustment is necessary in relation to age.
Danish: Ingen anden dosisjustering er nødvendig i relation til alder.
English: Special populations:
Danish: Særlige grupper:
English: The clinical relevance of this interaction has not been studied.
Danish: Den kliniske relevans af denne interaktion er ikke undersøgt.
English: These patients should also start with the 5 mg dose.
Danish: Disse patienter bør også starte på 5 mg dosis.
English: The contribution of environmental and genetic factors to these observed differences has not been determined.
Danish: De miljømæssige og genetiske bidrag til disse forskelle er ikke fastlagt.
English: However, the combination has been extensively used in women in clinical trials and was well tolerated.
Danish: Dog har kombinationen været udbredt hos kvinder i de kliniske undersøgelser og var her veltolereret.
English: 2745-663 Barcarena Portugal
Danish: 2745-663 Barcarena
English: There is no specific treatment in the event of overdose.
Danish: Der findes ingen særlig behandling ved overdosering.
English: {Name and address}
Danish: {Navn og adresse}
English: CK levels should be measured in these patients.
Danish: CK værdier bør måles hos disse patienter.
English: Before Treatment
Danish: Inden behandling
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE/INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: This interaction may be caused by the increase in gut motility caused by erythromycin.
Danish: Denne interaktion kan skyldes en øget tarmmotilitet forårsaget af erythromycin.
English: Blisters of aluminium laminate/aluminium foil of 7, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 98 and 100 tablets and HDPE bottles of 30 and 100 tablets.
Danish: Blister af aluminium laminat/aluminium folie 7, 14, 15 , 20, 28, 30, 42, 50, 56, 60, 84, 98 og 100 tabletter samt HDPE beholder med 30 og 100 tabletter.
English: Rosuvastatin is excreted in the milk of rats.
Danish: Rosuvastatin udskilles i mælken hos rotter.
English: This effect was mitigated when the antacid was dosed 2 hours after Crestor.
Danish: Dette blev mindsket, når antacida blev doseret 2 timer efter Crestor.
English: (adjusted mean percent change from baseline)
Danish: (justeret gennemsnitsændring fra baselinien i procent).
English: The potential relevance of need of >45% reduction of LDL-C, and that this could be taken into account in an individualised choice of start dose, has already been acknowledged by CHMP for other products of this class.
Danish: Den mulige relevans af behovet for >45 % reduktion af LDL-C og det forhold, at dette ville kunne tages i betragtning gennem individualiseret valg af startdosis, anerkendes i forvejen af CHMP for andre produkter af denne kategori.
English: This is reflected in available treatment guidelines from learned societies.
Danish: Dette afspejler sig i de behandlings-guidelines, der er udarbejdet af videnskabelige selskaber.
English: The geometric mean plasma clearance is approximately 50 litres/hour (coefficient of variation 21.7%).
Danish: Den geometriske middelplasmaclearence er ca. 50 liter/time (variationskoefficient 21,7 %).
English: There are no changes in pharmacokinetic parameters following multiple daily doses.
Danish: Der ses ingen ændringer i farmakokinetiske parametre efter gentagne daglige doser.
English: 6.6 Instructions for use and handling < and disposal> No special requirements.
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering <samt bortskaffelse> Ingen særlige forholdsregler.
English: F-92844 Rueil-Malmaison Cedex
Danish: F-92844 Rueil-Malmaison Cedex Frankrig
English: Creatine Kinase Measurement
Danish: Creatinin kinase måling
English: Therefore, the combination of Crestor and gemfibrozil is not recommended.
Danish: Derfor bør kombinationen af Crestor og gemfibrozil undgås.
English: Approximately 5% is excreted unchanged in urine.
Danish: Ca. 5 % udskilles uomdannet i urinen.
English: Specialist supervision is recommended when the 40 mg dose is initiated.
Danish: Der anbefales specialist overvågning, når doser på 40 mg påbegyndes.
English: However, based on its pharmacodynamic properties, Crestor is unlikely to affect this ability.
Danish: Baseret på dets farmakodynamiske egenskaber er det usandsynligt at Crestor påvirker denne evne.
English: Updated clinical trials information and post-marketing data do not provide grounds to change this assessment or to recommend specific amendments to the prescribing information for this dose level.
Danish: Ajourførte oplysninger fra kliniske undersøgelser og post-marketing oplysninger giver ikke grund til at ændre denne vurdering eller anbefale nærmere bestemte ændringer af ordineringsoplysningerne for dette dosisniveau.
English: SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CRESTOR 5 mg (see
Danish: FAGLIGE KONKLUSIONER SAMLET RESUME AF DEN FAGLIGE VURDERING AF CRESTOR 5 mg (se bilag I)
English: Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).
Danish: Hver tablet indeholder 5 mg rosuvastatin (som rosuvastatin calcium).
English: Available data do not allow conclusion on a general threshold level beyond which further reduction of LDL-C is futile.
Danish: De foreliggende oplysninger giver ikke grundlag for at fastlægge en generel tærskelværdi, ud over hvilken yderligere nedsættelse af LDL-C er nytteløs.
English: Discontinuation or down titration of Crestor may result in a decrease in INR.
Danish: Seponering eller nedtitrering af Crestor kan resultere i et fald i INR.