FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the identified divergences in the nationally approved product information, the CHMP also considered it to be of community interest to harmonise the product information across the EU.
Danish: På baggrund af de konstaterede afvigelser i den nationalt godkendte produktinformation fandt CHMP desuden, at det ville være i Fællesskabets interesse at harmonisere produktoplysningerne i hele EU.
English: The CHMP reviewed the broad indication for hypertension in the peri-operative period, which includes the pre-operative phase, the time of surgery itself and the post-operative period.
Danish: CHMP gennemgik den brede indikation hypertension i den perioperative periode bestående af den præoperative fase, selve operationen og den postoperative periode.
English: No suitable risk minimisation measures were identified to reduce the associated risks, given the nature of the patient population and the possible emergency setting in which IV nicardipine is used.
Danish: Der blev ikke fundet egnede risikominimeringsforanstaltninger til mindskelse af de tilknyttede risici i betragtning af patientpopulations art og de mulige akutte omstændigheder, som intravenøst nicardipin anvendes under.
English: Intravenous nicardipine can also continue to be used in malignant arterial hypertension/hypertensive encephalopathy; however, due to the risk of intracranial pressure elevation, the CHMP recommended the addition of a warning on this risk.
Danish: Intravenøst nicardipin kan desuden fortsat anvendes ved malign arteriel hypertension/hypertensiv encefalopati; pga. risikoen for forhøjet intrakranielt tryk anbefalede CHMP imidlertid tilføjelse af en advarsel om denne risiko.
English: The RMS therefore decided to suspend the DCP procedure at day 210 and triggered a procedure under Article 31 of Directive 2001/83/EC, requesting the Committee for Medicinal Products for Human Use (CHMP) to review the benefit-risk of all intravenous nicardipine-containing products for intravenous use and to clarify the data supporting the licensing of these products.
Danish: Referencemedlemsstaten besluttede derfor at suspendere DCP-proceduren på dag 210 og indledte en procedure i medfør af artikel 31 i direktiv 2001/83/EF med anmodning til Udvalget for Lægemidler til Mennesker (CHMP) om at gennemgå benefit/risk-forholdet for alle produkter indeholdende nicardipin til intravenøs anvendelse og at præcisere de data, der ligger til grund for markedsføringstilladelsen for disse produkter.
English: The CHMP considered all data available in its assessment, including published studies, article and guideline reviews, expert statements, user surveys, national guidelines as well as safety data from post-marketing and marketing authorisation holder databases.
Danish: I sin vurdering tog CHMP alle foreliggende data i betragtning, herunder publicerede undersøgelser, oversigter i artikler og retningslinjer, ekspertudtalelser, brugerundersøgelser, nationale retningslinjer samt sikkerhedsdata fra overvågning efter markedsføring og databaser hos indehaveren af markedsføringstilladelsen.
English: The CHMP also made significant revisions to the posology section of the product information, including bringing the recommendations in special populations in line with current knowledge of the use of intravenous nicardipine.
Danish: CHMP foretog desuden væsentlige revisioner af afsnittet om dosering i produktinformationen, således at anbefalingerne til særlige populationer bringes på linje med den nuværende viden om anvendelse af intravenøst nicardipin.
English: With regards to hypotension, the CHMP considered that the use of intravenous nicardipine for this indication is no longer relevant in the context of current surgical and anaesthetic practice.
Danish: For hypotension fandt CHMP, at anvendelse af intravenøst nicardipin til denne indikation ikke længere er relevant i den nuværende kirurgiske og anæstetiske praksis.
English: Nicardipine is a calcium channel blocker of the dihydropyridine type which is primarily effective via peripheral vasodilatation in vascular smooth muscle rather than cardiac muscle.
Danish: Nicardipin er en calciumantagonist af dihydropyridintypen, der primært virker via perifer vasodilatation i glatmuskulaturen i karrene frem for i hjertemusklen.
English: Considering the limited efficacy data and overall safety profile, the CHMP therefore considered that the indications in hypotension should be removed from the product information.
Danish: I betragtning af de begrænsede data om virkning og den overordnede sikkerhedsprofil fandt CHMP derfor, at indikationerne knyttet til hypotension bør slettes fra produktinformationen.
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen Ud fra følgende betragtninger:
English: Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
Danish: Desuden blev rejst væsentlige betænkeligheder ved administration af intravenøst nicardipin som bolusinjektion eller direkte intravenøs administration på grund af den højere potentielle risiko for iatrogen hypotension, navnlig ved præeklampsi.
English: Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia.
Danish: Efter gennemgang af de foreliggende sikkerhedsdata bemærkede CHMP, at de almindeligste bivirkninger og de, der oftest medfører seponering af lægemidlet, er virkninger på hjerte-karsystemet og nervesystemet knyttet til lægemidlets forventede vasodilaterende effekt, dvs. hovedpine, hypotension, rødme, ødem og takykardi.
English: • The Committee considered that in view of the identified serious limitations of the efficacy data and the overall safety profile of nicardipine, the benefits were no longer considered to outweigh the risks for some indications, which should therefore be removed;
Danish: • i betragtning at de konstaterede alvorlige begrænsninger i dataene om virkning og den overordnede sikkerhedsprofil af nicardipin fandt udvalget, at fordelene for visse indikationers vedkommende ikke længere kunne anses for at overstige risiciene, og at disse indikationer derfor bør slettes,
English: The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting.
Danish: CHMP konkluderede, at der kun foreligger data til støtte for anvendelse af nicardipin ved postoperativ hypertension.
English: Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
Danish: Efter modtagelse af en ansøgning om markedsføringstilladelse ved den decentrale procedure (DCP) for et generisk produkt indeholdende nicardipin til intravenøs (IV) anvendelse (10 mg/10 ml injektionsvæske, opløsning) og efter vurdering af ansøgningens dossier fandt referencemedlemsstaten (RMS) Det Forenede Kongerige de forelagte kliniske data utilstrækkelige til fastlæggelse af virkning, sikkerhed og overordnet benefit/risk-forhold af nicardipin til de ansøgte indikationer.
English: The CHMP therefore concluded that nicardipine for intravenous use should only be administered by continuous infusion and not by bolus dose administration, due to the abovementioned safety concerns.
Danish: CHMP konkluderede derfor, at intravenøs anvendelse af nicardipin kun bør ske ved kontinuerlig infusion og ikke ved bolusinjektion på baggrund af ovennævnte sikkerhedsmæssige betænkeligheder.
English: The Committee, as a consequence, concluded that the benefit-risk balance of intravenous nicardipinecontaining medicinal products remains positive, taking into account the restrictions, warnings and other changes to the product information.
Danish: Udvalget konkluderede følgelig, at benefit/risk-forholdet for lægemidler indeholdende nicardipin fortsat er positivt under forudsætning af de vedtagne begrænsninger samt advarsler og andre ændringer af produktinformationen.
English: The CHMP considered that overall, sufficient evidence is available on the safety and efficacy of nicardipine containing medical products for IV use in the treatment of post-operative hypertension and treatment of acute life-threatening hypertension in specific settings, with appropriate specialist intervention and monitoring and when used by specialists.
Danish: CHMP fandt, at der overordnet foreligger tilstrækkelig evidens for sikkerheden og virkningen af lægemidler indeholdende nicardipin til intravenøs behandling af postoperativ hypertension og akut livstruende hypertension under nærmere bestemte omstændigheder med passende specialintervention og overvågning, hvor anvendelsen forestås af specialister.
English: There are safety concerns associated with the use of nicardipine in patients with left ventricular heart failure as well as in patients with suspected coronary artery disease and therefore nicardipine should no longer be used for acute severe hypertension with accompanying left ventricular decompensation and pulmonary oedema.
Danish: Der er sikkerhedsmæssige betænkeligheder forbundet med anvendelse af nicardipin ved venstresidig hjerteinsufficiens samt ved formodet koronararteriesygdom, hvorfor nicardipin ikke længere bør anvendes til akut svær hypertension med ledsagende dekompenseret insufficiens af venstre ventrikel og lungeødem.
English: • The Committee considered that the available efficacy data is supportive of the use of nicardipine for intravenous use in the treatment of acute life-threatening hypertension and post-operative hypertension;
Danish: • udvalget fandt, at de foreliggende data om virkning støtter intravenøs anvendelse af nicardipin til behandling af akut livstruende hypertension og postoperativ hypertension,
English: In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Danish: På baggrund af den foreliggende evidens og den aktuelle medicinske viden om anvendelsen af intravenøst nicardipin og i betragtning af de potentielt alvorlige bivirkninger ved anvendelse af nicardipin fandt CHMP, at benefit/risk-forholdet for intravenøst nicardipin er negativt til visse indikationer som følge af de alvorlige begrænsninger i dataene om virkning.
English: These adverse effects are consistent with other dihydropyridine calcium channel blockers and were not considered to impact negatively on the benefit-risk balance of IV nicardipine.
Danish: Disse bivirkninger svarer til dem, der optræder med andre calciumantagonister af dihydropyridintypen og blev ikke anset for at influere negativt på benefit/risk-forholdet for intravenøst nicardipin.
English: The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective.
Danish: CHMP fandt, at intravenøs anvendelse af nicardipin har en rolle ved aortadissektion baseret på de forelagte oplysninger, evidensen for udbredt anvendelse, ekspertudtalelserne og fraværet af nye sikkerhedssignaler hos denne patientpopulation; ud fra den foreliggende evidens anbefalede CHMP imidlertid, at det anvendes som andetvalgspræparat, når behandling med korttidsvirkende betablokkere ikke er egnet, eller kombineret med en betablokker, når betablokade alene ikke er effektiv.
English: Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated.
Danish: Skønt nicardipin i nogle medlemsstater anvendes som førstevalgspræparat, fandt CHMP, at en indikation som andetvalgspræparat er passende for intravenøst nicardipin til præeklampsi, og fastlagde indikationen svær præeklampsi, når andre intravenøse antihypertensiva frarådes anvendt eller er kontraindiceret.
English: • The Committee considered that the product information should be updated, including with regard to the therapeutic indications and advised that nicardipine should only be administered by continuous infusion and not by bolus dose administration, due to safety concerns.
Danish: • udvalget anbefalede, at produktinformationen opdateres, herunder de terapeutiske indikationer, og tilrådede, at nicardipin på grund af sikkerhedsbetænkeligheder kun administreres ved kontinuerlig infusion og ikke ved bolusinjektion, konkluderede udvalget, at benefit/risk-forholdet for lægemidler indeholdende nicardipin til intravenøs anvendelse fortsat er positivt under normale anvendelsesbetingelser under forudsætning af de vedtagne ændringer af produktinformationen.
English: In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Danish: Desuden fandt referencemedlemsstaten betydelige afvigelser mellem de forelagte oplysninger og oplysningerne om dosering og sikkerhed i det foreslåede produktresumé.
English: The usual dose is 40 mg once a day, taken preferably in the morning.
Danish: Den sædvanlige dosis er 40 mg en gang dagligt, der fortrinsvis tages om morgenen.
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere oplysninger fremgår af resuméet af riskostyringsplanen.
English: The full EPAR and risk management plan summary for Neofordex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Neofordex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death.
Danish: Det gør det ved at virke sammen med forskellige proteiner (nuklear faktor kB og caspase 9), der regulerer celledød.
English: This is a summary of the European public assessment report (EPAR) for Neofordex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neofordex.
English: This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength.
Danish: Det betyder, at det svarer til et referencelægemiddel, der indeholder samme aktive stof, men Neofordex fås i en højere styrke.
English: A risk management plan has been developed to ensure that Neofordex is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Neofordex anvendes så sikkert som muligt.
English: Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression.
Danish: Mindre almindelige, men alvorlige, bivirkninger omfatter lungebetændelse (pneumoni) og andre infektioner, samt psykiske sygdomme såsom depression.
English: Neofordex is available as 40 mg tablets.
Danish: Neofordex fås som 40 mg tabletter.
English: Other information about Neofordex
Danish: Andre oplysninger om Neofordex
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences).
Danish: Multipelt myelom er kræfttype, der udgår fra hvide blodlegemer kaldet plasmaceller, som er en del af kroppens naturlige forsvar (immunsystemet).
English: Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality).
Danish: Neofordex må ikke anvendes hos patienter med aktiv virussygdom (specielt leverbetændelse, forkølelsessår, helvedesild og skoldkopper) eller med ukontrolleret ændret virkelighedsopfattelse (psykose).
English: Neofordex dexamethasone
Danish: Neofordex dexamethason
English: The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase.
Danish: De hyppigste bivirkninger ved Neofordex (som optræder hos flere end 1 ud af 10 patienter) er for højt blodsukker (hyperglykæmi), søvnbesvær (insomni), muskelsmerter og muskelsvaghed, svaghed (asteni), træthed, hævelse (ødem) og vægtforøgelse.
English: The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: CHMP afgjorde derfor, at fordelene ved Neofordex overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse til anvendelse i EU.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Neofordex, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What measures are being taken to ensure the safe and effective use of Neofordex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Neofordex?
English: The reference medicine for Neofordex is Dectancyl.
Danish: Referencelægemidlet for Neofordex er Dectancyl.
English: However, the dose and how frequently Neofordex is given varies depending on the medicines it is given with and the patient's condition.
Danish: Dosis og dosishyppighed af Neofordex afhænger dog af de lægemidler, det gives sammen med, og patientens tilstand.
English: Neofordex can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.
Danish: Neofordex fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af multipelt myelom.
English: Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Danish: Neofordex kan desuden mindske forskellige bivirkninger af kræftbehandlingen såsom kvalme og opkastning.
English: For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Neofordex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Neofordex.
Danish: Det er ikke en praktisk vejledning i, hvordan Neofordex bør anvendes.
English: Because the effects of high-dose dexamethasone in multiple myeloma are well established, the company for Neofordex presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.
Danish: Da virkningerne af højdosis-dexamethason ved multipelt myelom er anerkendt, fremlagde virksomheden undersøgelser fra litteraturen om anvendelse af dexamethason til behandling af multipelt myelom.
English: Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms.
Danish: Neofordex er et lægemiddel, der anvendes sammen med kræftlægemidler til behandling af voksne med multipelt myelom, og som har udviklet symptomer.
English: What is Neofordex and what is it used for?
Danish: Hvad er Neofordex, og hvad anvendes det til?
English: Why is Neofordex approved?
Danish: Hvorfor blev Neofordex godkendt?
English: Neofordex contains the active substance dexamethasone.
Danish: Neofordex indeholder det aktive stof dexamethason.
English: In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells.
Danish: Ved multipelt myelom anvendes Neofordex sammen med kræftlægemidler til at dræbe de plasmaceller, der er kræftceller.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Neofordex har vist sig at være af en kvalitet, der kan sammenlignes med Dectancyl, og brugen af højdosis-dexamethason ved multipelt myelom er anerkendt.
English: What are the risks associated with Neofordex?
Danish: Hvilke risici er der forbundet med Neofordex?
English: It is a ‘hybrid medicine'.
Danish: Neofordex er et "hybridt lægemiddel".
English: For practical information about using Neofordex, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Neofordex, bør du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse i EU og til sine anbefalinger om anvendelsesbetingelserne for Neofordex.
English: For the full list of all side effects reported with Neofordex, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Neofordex fremgår af indlægssedlen.
English: The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids.
Danish: Det aktive stof i Neofordex, dexamethason, er et lægemiddel i gruppen af binyrebarkhormoner.
English: How is Neofordex used?
Danish: Hvordan anvendes Neofordex?
English: What benefits of Neofordex have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Neofordex?
English: How does Neofordex work?
Danish: Hvordan virker Neofordex?
English: In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.
Danish: Undersøgelsen viste, at Neofordex har en kvalitet, der kan sammenlignes med referencelægemidlet Dectancyl.
English: It is available as capsules (250 mg) and tablets (500 mg).
Danish: Det fås som kapsler (250 mg) og tabletter (500 mg).
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Danish: Det anvendes sammen med ciclosporin og kortikosteroider (andre lægemidler, der anvendes til at forebygge organafstødning).
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Danish: Dette enzym er vigtigt for dannelsen af dna i cellerne, især i lymfocytterne (en slags hvide blodceller, der deltager i afstødningen af transplanterede organer).