FrancophonIA/ELRC3.0 huggingface dataset:
English: Before starting treatment, your doctor may order blood tests to assess kidney function and may advise you to take the capsules less often or prescribe Emtriva oral solution.
Danish: Før De påbegynder behandlingen, kan Deres læge tage blodprøver for at bedømme nyrefunktionen og råder Dem måske til at tage kapslerne mindre hyppigt eller ordinerer Emtriva oral opløsning til Dem. Deres læge kan også tage blodprøver under behandlingen for at overvåge Deres nyrer.
English: Renal insufficiency: Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2).
Danish: Nyreinsufficiens: Emtricitabin elimineres ved renal udskillelse og eksponering for emtricitabin steg signifikant hos patienter med nyreinsufficiens (se pkt.
English: There is a separate Package Leaflet for Emtriva 200 mg hard capsules.
Danish: Der findes en særskilt indlægsseddel til Emtriva 200 mg hårde kapsler.
English: Emtriva 10 mg/mL oral solution Emtricitabine
Danish: Emtriva 10 mg/ml oral opløsning Emtricitabin
English: In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a PI or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/mL) through 48 weeks (77% emtricitabine, 82% lamivudine).
Danish: Hos virologisk stabile, behandlingserfarne voksne viste det sig, at emtricitabin, i kombination med en NRTI (enten stavudin eller zidovudin) og en PI eller en NNRTI ikke var mindre effektiv end lamivudin med hensyn til procentdelen af responderende (< 400 kopier/ml) i 48 uger (77% emtricitabin, 82% lamivudin).
English: Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
Danish: Derfor bør klinisk respons på behandling og nyrefunktionen monitoreres tæt hos patienter, som behandles med en reduceret dosis af emtricitabin (se pkt.
English: One 200 mg hard capsule every 24 hours
Danish: Én 200 mg hård kapsel hver 24. time
English: One 200 mg hard capsule every 72 hours
Danish: Én 200 mg hård kapsel hver 72. time
English: In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a protease inhibitor (PI) or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/mL) through 48 weeks (77% emtricitabine, 82% lamivudine).
Danish: Hos virologisk stabile, behandlingserfarne voksne viste det sig, at emtricitabin, i kombination med en NRTI (enten stavudin eller zidovudin) og proteasehæmmer (PI) eller en NNRTI ikke var mindre effektiv end lamivudin med hensyn til procentdelen af responderende (< 400 kopier/ml) i 48 uger (77% emtricitabin, 82% lamivudin).
English: Exacerbations of hepatitis after discontinuation of treatment: In HIV infected patients co-infected with HBV, exacerbations of hepatitis may occur after discontinuation of treatment (see section 4.4).
Danish: Hepatitis-eksacerbationer efter seponering af behandling: Hos hiv-inficerede patienter, som samtidigt er inficerede med HBV, er der forekommet hepatitis-eksacerbationer efter seponering af behandlingen (se pkt.
English: Emtriva 200 mg hard capsules Emtricitabine
Danish: Emtriva 200 mg hårde kapsler Emtricitabin
English: Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over.
Danish: Emtriva er indiceret til behandling af voksne og børn på 4 måneder og derover inficerede med human immundefekt virus 1 (hiv 1) i kombination med andre antiretrovirale lægemidler.
English: The following side effects are very common (these can affect at least 10 in every 100 patients):
Danish: Følgende bivirkninger er meget almindelige (de kan opstå hos flere end 10 ud af 100 patienter):
English: There is a separate Package Leaflet for Emtriva 10 mg/mL oral solution.
Danish: Der findes en særskilt indlægsseddel til Emtriva 10 mg/ml oral opløsning.
English: Emtriva has not been studied in patients over 65 years of age.
Danish: Emtriva er ikke blevet undersøgt hos patienter over 65 år.
English: If you take more Emtriva than you should
Danish: Hvis De har taget for meget Emtriva
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Emtriva til Dem personligt.
English: Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
Danish: På grund af denne forskel i biotilgængeligheden bør 240 mg emtricitabin administreret som den orale opløsning give samme plasmaniveauer som dem, der observeredes efter administration af én 200 mg emtricitabin hård kapsel.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Emtriva (see section 4.2).
Danish: Da det er mere sandsynligt, at ældre patienter har nedsat nyrefunktion, skal der udvises forsigtighed ved behandling af ældre patienter med Emtriva (se pkt.
English: Emtriva 10 mg/mL oral solution
Danish: Emtriva 10 mg/ml oral opløsning
English: Methyl parahydroxybenzoate (E218) Propylene glycol
Danish: Methylparahydroxybenzoat (E218) Propylenglycol
English: Emtriva 200 mg hard capsules
Danish: Emtriva 200 mg hårde kapsler
English: Contents of the pack and other information What Emtriva contains
Danish: Pakningsstørrelser og yderligere oplysninger Emtriva indeholder:
English: If you experience dizziness while taking Emtriva, do not drive and do not use any tools or machines.
Danish: Kør ikke bil eller motorcykel og lad være med at cykle, og lad være med at arbejde med værktøj eller maskiner, hvis De bliver svimmel, når De tager Emtriva.
English: Each Emtriva hard capsule contains 200 mg of emtricitabine.
Danish: Hver hård kapsel Emtriva indeholder 200 mg emtricitabin.
English: Each hard capsule contains 200 mg of emtricitabine.
Danish: Hver hård kapsel indeholder 200 mg emtricitabin.
English: HIV/HBV co-infected patients: The adverse reaction profile in patients co-infected with HBV is similar to that observed in patients infected with HIV without co-infection with HBV.
Danish: Patienter, som både er inficerede med hiv og HBV: Bivirkningsprofilen hos patienter, som samtidigt er inficerede med HBV, ligner den, der observeres hos patienter, som er inficerede med hiv, men ikke samtidigt er inficerede med HBV. Som det kunne forventes, forekom stigninger i ASAT og ALAT dog hyppigere hos denne patientpopulation end i den generelle hiv-inficerede population.
English: Emtriva oral solution contains sunset yellow (E110) which may cause allergic reactions, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Danish: Emtriva, oral opløsning, indeholder også methylparahydroxybenzoat (E218) og propylparahydroxybenzoat (E216), som ligeledes kan give allergiske reaktioner (muligvis forsinkede).
English: If you are sick (vomit) If it's less than an hour since you took Emtriva, take another capsule.
Danish: Hvis De kaster op Hvis det er mindre end en time siden, De har taget Emtriva, skal De tage en ny kapsel.
English: BOTTLE AND CARTON LABELLING
Danish: TEKST PÅ FLASKE OG ÆSKE
English: Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (see sections 4.2 and 5.2).
Danish: Derfor bør klinisk respons på behandling og nyrefunktionen monitoreres tæt hos patienter, som behandles med emtricitabin med længere dosisintervaller (se pkt.
English: Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
Danish: Se venligst produktresumeet til Emtriva 200 mg hårde kapsler.
English: Discontinuation of Emtriva therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Danish: Seponering af Emtrivabehandlingen hos hiv-inficerede patienter, der samtidig er inficeret med HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis (se pkt.
English: Each mL of Emtriva oral solution contains 10 mg of emtricitabine.
Danish: Hver ml af Emtriva oral opløsning indeholder 10 mg emtricitabin.
English: Dose or dose interval adjustment is required in all patients with creatinine clearance < 30 mL/min (see section 4.4).
Danish: Det er nødvendigt at justere dosis eller dosisintervallet hos alle patienter med kreatininclearance < 30 ml/min (se pkt.
English: In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/kg once daily.
Danish: De nyfødte fik to 4 dages behandlinger med emtricitabin oral opløsning mellem deres første leveuge og 3 måneders alderen med en dosis på 3 mg/kg én gang dagligt.
English: Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Danish: På grund af forskellen i biotilgængeligheden af emtricitabin mellem den hårde kapsel og den orale opløsning (24 ml) bør 240 mg emtricitabin administreret som oral opløsning give lignende plasmaniveauer som dem, der observeres efter administration af én 200 mg emtricitabin hård kapsel (se pkt.
English: Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Danish: På grund af forskellen i biotilgængeligheden af emtricitabin mellem den hårde kapsel og den orale opløsning, bør 240 mg emtricitabin administreret som oral opløsning give lignende plasmaniveauer som dem, der observeres efter administration af én 200 mg emtricitabin hård kapsel (se pkt.
English: Other possible effects
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER
English: Emtriva hard capsules have a white opaque body with a light blue opaque cap. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Danish: Hver kapsel er påtrykt ”200 mg” på overdelen og ”GILEAD” samt [Gilead logo] i sort på underdelen.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Til de mange risikofaktorer for udvikling af denne sygdom hører blandt andre: Varigheden af den samtidige behandling med flere slags antiretroviral medicin, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar samt overvægt (højt Body Mass Index (BMI)).
English: Musculoskeletal and connective tissue disorders: Very common:
Danish: Knogler, led, muskler og bindevæv: Meget almindelig:
English: This is because the active substance in this medicine passes into human breast milk.
Danish: • De må ikke amme, hvis De tager Emtriva, fordi det aktive stof i denne medicin udskilles i mælken hos mennesker.
English: Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution.
Danish: Se produktresumeet til Emtriva 10 mg/ml oral opløsning.
English: Gastrointestinal disorders: Very common:
Danish: Mave-tarm-kanalen: Meget almindelig:
English: This medicine contains 36 mg of sodium (main component of cooking/table salt) per 24 mL dose.This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette lægemiddel indeholder 36 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. 24 mldosis.
English: If it's less than an hour since you took Emtriva, take another dose.
Danish: Hvis De kaster op Hvis det er mindre end en time siden, De har taget Emtriva, tages dosis en gang til.
English: < 15 (functionally anephric, requiring intermittent haemodialysis)*
Danish: Kreatininclearance (ml/min) < 15 (svigt af nyrefunktion med behov for periodisk hæmodialyse)*
English: BLISTER CARTON LABELLING
Danish: TEKST PÅ BLISTERÆSKE
English: dizziness
Danish: svimmelhed
English: London, 24 April 2008 Doc.
Danish: London, den 24. april 2008 Dok.
English: International non-proprietary name (INN): clofarabine
Danish: Internationalt fællesnavn (INN): clofarabin
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF A CHANGE TO THE MARKETING AUTHORISATION for EVOLTRA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM ÆNDRING AF MARKEDSFØRINGSTILLADELSEN for EVOLTRA
English: What is happening for Evoltra for treatment of ALL in children?
Danish: Hvad sker der med Evoltra til behandling af ALL hos børn?
English: What is Evoltra?
Danish: Hvad er Evoltra?
English: On 18 March 2008, Bioenvision Ltd, a wholly owned subsidiary of Genzyme Corporation, officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Evoltra.
Danish: Den 18. marts 2008 meddelte Bioenvision Ltd, et helejet datterselskab af Genzyme Corporation, officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at trække sin ansøgning om ændring af markedsføringstilladelsen for Evoltra tilbage.
English: It belongs to the group of anti-cancer medicines called ‘antimetabolites'.
Danish: Det hører til den gruppe af lægemidler mod kræft, der hedder antimetabolitter.
English: What was Evoltra expected to be used for?
Danish: Hvad forventedes Evoltra anvendt til?
English: There were also some concerns over the medicine's side effects affecting the kidneys.
Danish: Der var også betænkeligheder med hensyn til lægemidlets bivirkninger i nyrerne.
English: There are no consequences on the use of Evoltra in the authorised indication, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Evoltra til den godkendte indikation, for hvilken benefit/riskforholdet forbliver uændret.
English: This stops the cells making new DNA and slows down the growth of tumour cells.
Danish: Dette forhindrer cellerne i at danne nyt dna og forsinker væksten af tumorceller.
English: It is used when the disease has not responded to, or has come back (relapsed), after at least two other treatments, and when no other treatment is expected to work.
Danish: Det anvendes til patienter, som ikke har responderet, eller som har haft tilbagefald (sygdommen er kommet tilbage) efter mindst to andre behandlinger, og når ingen anden behandling forventes at virke.
English: Evoltra was designated as an orphan medicine for this condition on 8 May 2003.
Danish: Evoltra blev udpeget som lægemiddel til sjældne sygdomme til denne sygdomstilstand den 8. maj
English: The study did not compare Evoltra with any other treatment.
Danish: I undersøgelsen blev Evoltra ikke sammenlignet med andre behandlinger.
English: The change concerned an extension of indication to add the treatment of acute myeloid leukaemia in elderly patients.
Danish: Ændringen vedrørte en udvidelse af indikationen til også at omfatte behandling af akut myeloid leukæmi hos ældre patienter.
English: It contains the active substance clofarabine.
Danish: Det indeholder det aktive stof clofarabin.
English: It was to be used in patients who are not suitable for intensive chemotherapy, because they have certain genetic abnormalities in their myeloid cells, ‘secondary' AML (AML following a previous blood disorder) or another disease in addition to AML, or because they are 70 years of age or older.
Danish: Det skulle anvendes til patienter, som ikke er egnede til intensiv kemoterapi, fordi de har visse genetiske anomalier i de myeloide celler, “sekundær” AML (AML efter en tidligere blodsygdom) eller en anden sygdom ud over AML, eller fordi de er 70 år eller ældre.
English: How is Evoltra expected to work?
Danish: Hvordan forventes Evoltra at virke?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Evoltra had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Evoltra ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Evoltra is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Evoltra er et koncentrat, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: Clofarabine is an analogue of adenine, which is part of the DNA, the fundamental genetic material of cells.
Danish: Clofarabin er en analog til adenin, som er en del af dna'et, cellernes grundlæggende genetiske materiale.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Evoltra could not have been approved for the treatment of the treatment of AML in elderly patients.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Evoltra ikke kunne have været godkendt til behandling af AML hos ældre patienter.
English: The active substance in Evoltra, clofarabine, is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells).
Danish: Det aktive stof i Evoltra, clofarabin, er en cellegift (et lægemiddel, der dræber celler, der deler sig, f.eks. kræftceller).
English: The company presented results from one main study involving 66 patients aged 65 years or older with AML, who had not been treated before and were considered to be unsuitable for intensive chemotherapy.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med 66 patienter, i alderen 65 år eller derover, med AML, som ikke havde fået behandling tidligere og ikke fandtes egnede til intensiv kemoterapi.
English: The Committee was concerned that the main study included a number of patients who could have been suitable for intensive chemotherapy and this could have made the effectiveness of Evoltra look more promising.
Danish: Udvalget fandt grund til betænkelighed ved, at hovedundersøgelsen omfattede en række patienter, som kunne have fået intensiv kemoterapi, og at dette kan have fået virkningen af Evoltra til at se mere lovende ud.
English: In the body, clofarabine takes the place of adenine, and interferes with the enzymes involved in making genetic material.
Danish: Clofarabin indtager adenins plads i kroppen og påvirker de enzymer, der medvirker ved dannelsen af genetisk materiale.
English: The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Danish: Virkningen blev hovedsageligt bedømt på antallet af patienter, der gik i “remission” (leukæmien forsvandt fra knoglemarven, og antallet af blodlegemer blev bragt helt eller delvist tilbage til det normale niveau).
English: The CHMP was concerned that the main study was not sufficient to establish the benefit of Evoltra in the treatment of AML in elderly patients who were unsuitable for intensive chemotherapy, and that the results of a study comparing Evoltra with standard treatment would be necessary to determine the medicine's effectiveness.
Danish: CHMP fandt grund til betænkelighed ved, at hovedundersøgelsen ikke var tilstrækkelig til at påvise den gavnlige virkning af Evoltra til behandling af AML hos ældre patienter, som var uegnede til intensiv kemoterapi, og at det var nødvendigt at se resultaterne af en undersøgelse, hvori Evoltra blev sammenlignet med standardbehandling, for at påvise lægemidlets virkning.
English: Evoltra is already used to treat children with acute lymphoblastic leukaemia (ALL, cancer of the lymphocytes, a type of white blood cell).
Danish: Evoltra anvendes allerede til behandling af børn med akut lymfoblastisk leukæmi (ALL, kræft i lymfocytterne, en type hvide blodlegemer).
English: In the new indication, Evoltra was also expected to be used to treat patients aged over 65 years who have acute myeloid leukaemia (AML, cancer of the myeloid cells, a type of immature white blood cell).
Danish: Til den nye indikation forventedes Evoltra ligeledes anvendt til behandling af patienter over 65 år med akut myeloid leukæmi (AML, kræft i de myeloide celler, en type umodne hvide blodlegemer).
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Evoltra?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Evoltra eller i programmer for anvendelse af Evoltra med særlig udleveringstilladelse?
English: The company informed the CHMP that this withdrawal has no consequences for patients enrolled in clinical trials or compassionate use programmes with Evoltra.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med Evoltra eller i programmer for anvendelse af Evoltra med særlig udleveringstilladelse.
English: Within 3 months of Commission Decision
Danish: Senest 3 måneder efter Kommissionens beslutning
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Danish: De nationale kompetente myndigheder sikrer med referencemedlemsstaten som koordinerende instans, at indehaveren af markedsføringstilladelserne opfylder følgende betingelser:
English: As part of this study the MAH shall actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Danish: Som led i denne undersøgelse skal indehaveren af markedsføringstilladelsen aktivt indhente rapporter om misbrug, fejlanvendelse, ulovlig anvendelse og afhængighed hos børn med ADHD fra giftkontrolcentre, narkotikaovervågningscentre, andre databaser og offentligt tilgængelige kilder i litteraturen og online.
English: This 5 years retrospective (new users) study will also compare the relative risk between dexamfetamine and other stimulants in the patient population.
Danish: Denne retrospektive 5-årige undersøgelse (af nye brugere) skal desuden sammenligne dexamfetamin med andre centralt stimulerende midler hvad angår risikoen hos patientpopulationen.
English: The applicant shall conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Danish: Ansøgeren udfører en sikkerhedsundersøgelse efter markedsføring (PASS) til vurdering af den langsigtede sikkerhedsprofil af dexamfetamin hos børn med ADHD, navnlig med henblik på hovedproblemer såsom kardiovaskulære hændelser og bivirkninger af vækstmæssig og psykiatrisk art.
English: 3. annex 7: should include the text of a proposed follow up form to be used for specific adverse event follow-up.
Danish: Bilag 7 skal indeholde tekst til en foreslået formular til opfølgning af specifikke bivirkninger.