FrancophonIA/ELRC3.0 huggingface dataset:
English: If it has been more than 12 hours since the dose was due only take the next dose at the usual time.
Danish: Hvis, der er gået mere end 12 timer, skal du springe den glemte dosis over og tage næste dosis til sædvanlig tid.
English: Table 4: Summary of lipid laboratory values at baseline (screening) and week 48 - study
Danish: Tabel 4: Lipidværdier ved baseline (screening) og efter uge 48 - studie 1100.1486 Viramune 200 mg
English: Enfuvirtide and Viramune can be coadministered without dose adjustments.
Danish: Enfuvirtid og Viramune kan coadministreres uden dosisjustering.
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - decreased numbers of red blood cells (anaemia) - decreased numbers of white blood cells (granulocytopenia) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - muscle pain (myalgia) - joint pain (arthralgia) - decreased blood phosphorus - increased blood pressure
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - allergiske reaktioner (overfølsomhed) - allergisk reaktion karakteriseret ved udslæt, hævelse af ansigt, åndenød (bronkospasme) eller anafylaktisk shock - lægemiddelforårsaget udslæt (med eosinofili og systemiske symptomer) - pludselig og kraftig leverbetændelse (fulminant leverbetændelse) - alvorlige og livstruende hudreaktioner (Stevens-Johnsons syndrom/toksisk epidermal nekrolyse) - nedsat antal af røde blodlegemer (anæmi) - nedsat antal af hvide blodlegemer (granulocytopeni) - gulsot - nældefeber - væskedannelse under huden (angioødem) - muskelsmerter (myalgi) - ledsmerter - nedsat indhold af fosfat i blodet - forhøjet blodtryk
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 100 mg of nevirapine (as anhydrous)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 depottablet indeholder 100 mg nevirapin (vandfri).
English: Recommended paediatric dosing by BSA after the lead-in period BSA (m2) Viramune prolonged-release tablets dose (mg) 0.58-0.83 200 (2 x 100 mg) 0.84-1.16 300 (3 x 100 mg) 400 (1 x 400 mg)
Danish: 0,58-0,83 200 (2 x 100 mg) 0,84-1,16 300 (3 x 100 mg)
English: NAME OF THE MEDICINAL PRODUCT Viramune 100 mg prolonged-release tablets nevirapine
Danish: LÆGEMIDLETS NAVN Viramune 100 mg depottabletter nevirapin
English: n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
Danish: Dette antyder, at patienter med forværring af den hepatiske funktion og ascites risikerer akkumulering af nevirapin i den systemiske cirkulation.
English: Viramune prolonged-release tablets have not been studied in patients with renal dysfunction and Viramune immediate-release should be used.
Danish: Viramune depottabletter er ikke blevet undersøgt hos patienter med nedsat leverfunktion og Viramune tabletter bør benyttes.
English: The safety data include all patient visits up to the time of the last patient's completion of study week 144.
Danish: Ved alle patientbesøg frem til sidste patient fuldførte uge 144 blev der foretaget bivirkningsregistrering.
English: Uncommon (may affect up to 1 in 100 people): - allergic reactions (hypersensitivity) - allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock - drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms) - sudden and intense inflammation of the liver (fulminant hepatitis) - severe and life-threatening skin rashes (Stevens Johnson Syndrome/toxic epidermal necrolysis) - yellow skin (jaundice) - hives (urticaria) - fluid under the skin (angioneurotic oedema) - vomiting - muscle pain (myalgia) - joint pain (arthralgia) - decreased numbers of white blood cells (granulocytopenia) - abnormal liver function tests - decreased blood phosphorus - increased blood pressure
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - allergiske reaktioner (overfølsomhed) - allergisk reaktion karakteriseret ved udslæt, hævelse af ansigt, åndenød (bronkiespasmer) eller anafylaktisk shock - lægemiddelforårsaget udslæt (med eosinofili og systemiske symptomer) - pludselig og kraftig leverbetændelse (fulminant leverbetændelse) - alvorlige og livstruende hudreaktioner (Stevens-Johnsons syndrom/toksisk epidermal nekrolyse) - gulsot - nældefeber - væskedannelse under huden (angioødem) - opkastning - muskelsmerter (myalgi) - ledsmerter - nedsat antal af hvide blodlegemer (granulocytopeni) - leverfunktionsprøver uden for normalområdet - nedsat indhold af fosfat i blodet - forhøjet blodtryk
English: Entecavir and Viramune may be coadministered without dose adjustments.
Danish: Entecavir og Viramune kan coadministreres uden dosisjustering.
English: Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Viramune dose increased until the rash has resolved.
Danish: Overvejelser i forbindelse med fastsættelse af dosis Dosis af Viramune bør ikke øges til patienter, som udvikler udslæt i optrapningsperioden på 14 dage med 200 mg/dag, før udslættet er forsvundet.
English: If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Viramune.
Danish: Hvis du nogensinde får udslæt i mild grad uden nogle af de andre bivirkninger, skal du straks informere lægen om det.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease.
Danish: Risikofaktorer for udvikling af denne sygdom er blandt mange: Længden af den tidsperiode, hvor du er blevet behandlet med flere antiretrovirale lægemidler, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar, samt højt BMI (body-mass-index) Stivhed, ømhed og smerter i ledene (især hofte, knæ og skulder) samt besvær med at bevæge sig, er tegn på knoglenekrose.
English: The 200 mg once daily dosing regimen of Viramune immediate-release should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Danish: Doseringsregimenet for lead-in af Viramune 200 mg én gang dagligt bør ikke administreres i mere end 28 dage, da der er risiko for undereksponering og resistens.
English: 3 or in adult males with CD4 cell counts greater than 400 cells/mm
Danish: 3, mænd med over 400 celler/mm
English: If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells.Do not take Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.
Danish: Tag ikke Viramune hvis du er blevet udsat for hiv, med med mindre du er blevet diagnosticeret med hiv, og lægen har foreskrevet det. Viramune kan ikke helbrede en hiv-infektion.
English: If your child develops any rash during this period, do not start taking Viramune prolonged-release tablets but consult your child's doctor.
Danish: Hvis dit barn får nogen form for udslæt i denne periode, må behandling med Viramune depottabletter ikke opstartes.
English: The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Danish: 200 mg som dagsdosis bør ikke administreres i mere end 28 dage, da der er risiko for undereksponering og resistens og en alternativ medicinsk behandling bør vælges.
English: NAME OF THE MEDICINAL PRODUCT Viramune 400 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Viramune 400 mg depottabletter
English: anaphylactic reaction, angioedema and urticaria) has been reported.
Danish: anafylaktisk reaktion, angioødem, urticaria)
English: Adefovir and Viramune may be coadministered without dose adjustments.
Danish: Adefovir og Viramune kan coadministreres uden dosisjustering.
English: Viramune.
Danish: Viramune-behandlingen.
English: Stavudine and Viramune can be coadministered without dose adjustments.
Danish: Stavudin og Viramune kan coadministreres uden dosisjustering.
English: Lead-in dosing with Viramune 200 mg tablets or Viramune 50 mg/5 ml oral suspension (first 14 days): All paediatric patients should initiate therapy with 150 mg/m2 (calculated using the Mosteller formula)
Danish: Dosis i optrapningsperioden ( de første 14 dage) med Viramune 200 mg tabletter eller Viramune 50 mg/5ml oral suspension:
English: Gastrointestinal disorders Common nausea, vomiting, abdominal pain, diarrhoea Hepatobiliary disorders Common hepatitis (including severe and life-threatening hepatotoxicity) (1.9%) Uncommon jaundice
Danish: Hepatitis (inklusive svær og livstruende hepatotoksicitet) (1,9 %)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/055/006
English: Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy.
Danish: Før behandlingen med nevirapin igangsættes samt med passende mellemrum undervejs i behandlingen, skal der udføres biokemiske tests herunder test af leverfunktionen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/055/002
English: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.2).
Danish: Viramune er indiceret til behandling af hiv-1 smittede patienter (voksne, unge og børn) i kombination med andre antivirale lægemidler (se pkt.
English: Ribavirin and Viramune may be coadministered without dose adjustments.
Danish: Ribaverin og Viramune kan coadministreres uden dosisjustering.
English: Interferons and Viramune may be coadministered without dose adjustments.
Danish: Interferoner og Viramune kan coadministreres uden dosisjustering.
English: 3 for the groups receiving Viramune immediate-release and Viramune prolonged-release respectively.
Danish: 3 for de, der fik Viramune 200 mg, og de, der fik Viramune i depotform.
English: Uncommon Stevens-Johnson Syndrome/toxic epidermal necrolysis (which may be fatal) (0.6 %), angioedema, urticaria
Danish: Stevens-Johnsons syndrom/toksisk epidermal nekrolyse (som kan være letal) (0,6 %), angioødem, urticaria Knogler, led, muskler og bindevæv Ikke almindelig :
English: Severe or lifethreatening rash considered related to nevirapine treatment occurred in 1.1 % of patients during the lead-in phase with Viramune immediate-release.
Danish: Hos 1,1 % af patienterne i optrapningsfasen med Viramune 200 mg opstod der svært eller livstruende udslæt, der blev betragtet som nevirapinrelateret.
English: DMPA and Viramune can be co-administered without dose adjustments.
Danish: DMPA og Viramune kan coadministreres uden dosisjustering.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/055/004
English: Darunavir and Viramune can be coadministered without dose adjustments.
Danish: Darunavir og Viramune kan coadministreres uden dosisjustering.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ ÆSKE TIL BEHOLDER
English: NAME OF THE MEDICINAL PRODUCT Viramune 100 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Viramune 100 mg depottabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/055/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/97/055/007
English: Entecavir is not a substrate, inducer or an inhibitor of cytochrome P450 (CYP450) enzymes.
Danish: Entecavir er ikke substrat, induktor eller hæmmer af CYP-enzymer.
English: Depending on the outcome your doctor may decide to interrupt or stop Viramune treatment.
Danish: Lægen vil råde dig med hensyn til, om du skal stoppe Viramune-behandlingen.
English: Fosamprenavir/ritona vir 700/100 mg BID
Danish: Fosamprenavir/ritonav ir 700/100 mg 2 gange daglig
English: PIs
Danish: Køn
English: NNRTIs Efavirenz 600 mg QD
Danish: NNRTI'er Efavirenz 600 mg 4 gange dagligt
English: Viramune 400 mg prolonged-release tablets can be taken by children if they: - are  8 years of age and weigh 43.8 kg or more - are older than 3 years of age and below 8 years of age and weigh 25 kg or more - have a body surface area of 1.17 square metres or above.
Danish: - unge under 16 år, som - vejer 50 kg eller mere - eller har et legemsoverfladeareal på over 1,25 m
English: Uncommon Stevens-Johnson syndrome/ toxic epidermal necrolysis (which may be fatal)
Danish: tilfælde af Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN)) eller alvorlig hepatitis/leversvigt.
English: 300 mg QD
Danish: Dosis 7 mg/kg
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free'.
Danish: En tablet indeholder mindre end 1 mmol (23 mg) natrium, dvs. den er i det væsentlige natrium-fri. Alle hjælpestoffer er anført under pkt.
English: If you take more Viramune than you should
Danish: Hvis du har taget for meget Viramune
English: 24 July 2014 EMA/444346/2014
Danish: Den 24. juli 2014 EMA/444346/2014
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0)20 7418 8427 E-mail: 19TUpress@ema.europa.euU1
English: • Patients who have questions or concerns should consult their doctor or another healthcare professional.
Danish: • Patienter, der har spørgsmål eller betænkeligheder, bør kontakte lægen eller en anden sundhedsperson.
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: The review of oral methadone medicines containing povidone was initiated on 10 April 2014 under Article 107i of Directive 2001/83/EC, also known as the ‘urgent Union procedure'.
Danish: Gennemgangen af orale metadonlægemidler indeholdende povidon blev indledt den 10. april 2014 i henhold til artikel 107i i direktiv 2001/83/EF (også kaldet EU-hasteproceduren).
English: The efficacy of methadone in opioid substitution therapy was acknowledged and was not questioned in this review.
Danish: Virkningen af metadon til opioidsubstitutionsbehandling blev anerkendt og er ikke draget i tvivl ved denne gennemgang.
English: Methadone is also used in the treatment of severe pain.
Danish: Metadon anvendes desuden til behandling af svære smerter.
English: Oral solutions have been authorised in Denmark, Finland, Malta, Norway, Sweden and the United Kingdom; oral tablets have been authorised in Denmark, Finland, Hungary, Iceland, Norway, Romania, Spain and Sweden.
Danish: Orale tabletter er godkendt i Danmark, Finland, Ungarn, Island, Norge, Rumænien, Spanien og Sverige.
English: Treatment with methadone should be given in the context of a wider rehabilitation program.
Danish: Metadonbehandling bør anvendes i forbindelse med et bredere rehabiliteringsforløb.
English: These products will remain suspended until they have been reformulated.
Danish: Disse lægemidler vil være suspenderet, indtil de er blevet omformuleret.
English: Methadone medicines containing povidone have been authorised via national procedures in several European countries.
Danish: Lægemidler indeholdende povidon er godkendt ved nationale procedurer i en række europæiske lande.
English: Therefore, these products will remain on the
Danish: Disse lægemidler vil derfor fortsat være på markedet, men der vil blive
English: • While these medicines are suspended, healthcare professionals should switch their patients to alternative methadone products.
Danish: • Mens disse lægemidler er suspenderet, bør sundhedspersoner lade patienterne overgå til andre metadonlægemidler.
English: The PRAC recommendation was sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Anbefalingerne fra PRAC blev fremsendt til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)), som vedtog et endeligt standpunkt.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Danish: CMD(h) er en lægemiddelmyndighed, der repræsenterer EU's medlemsstater.
English: The above recommendations are based on available safety data on the risks associated with the misuse by injection of methadone medicines containing povidone.
Danish: Ovenstående anbefalinger er baseret på de foreliggende sikkerhedsdata vedrørende risici ved misbrug ved injektion af metadonlægemidler indeholdende povidon.
English: Methadone is a synthetic opioid (a morphine-like substance).
Danish: Metadon er et stof, der ligner morfin (et syntetisk opioid).
English: • Methadone tablets containing povidone of lower molecular weight can continue to be used, but patients are reminded that they should only be taken by mouth.
Danish: • Metadontabletter, der indeholder povidon med lavere molekylvægt, vil fortsat kunne anvendes, men patienterne skal gøres opmærksom på, at de kun må tages gennem munden.
English: • Since no measures could be identified to minimise the potential harm with methadone oral solutions containing high molecular weight povidone, these solutions will be suspended.
Danish: • Da der ikke kunne fastlægges foranstaltninger til minimering af den potentielle skade med orale metadonopløsninger indeholdende højmolekylært povidon, vil disse opløsninger blive suspenderet.
English: They will need to be appropriately reformulated before being reintroduced on the European market.
Danish: De skal omformuleres på passende måde, før de kan genindføres på markedet.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus the recommendation to suspend the marketing authorisation of methadone oral (by mouth) solutions containing high molecular weight povidone.
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h))P0F1P har med konsensus godkendt en anbefaling om at suspendere markedsføringstilladelsen for orale metadonopløsninger (til indtagelse gennem munden), der indeholder højmolekylært povidon.
English: Different types of povidone are available, which vary in their molecular weight (a measure of the size of the molecule).
Danish: Der findes flere typer povidon med forskellig molekylvægt (et mål for molekylets størrelse).
English: Povidone is available in different molecular weights.
Danish: Povidon findes med forskellige molekylvægte.
English: Additionally, the CMDh agreed that methadone tablets that contain low molecular weight povidone should remain on the market with changes to the product information.
Danish: CMD(h) vedtog desuden, at metadontabletter med lavmolekylært povidon skulle forblive på markedet, men at produktinformationen skulle ændres.
English: • Patients taking methadone oral solutions with povidone K90 as part of their rehabilitation program will be switched to other methadone medicines, which do not pose the same risk of povidone accumulating inside vital organs.
Danish: • Patienter, der som led i et rehabiliteringsforløb får orale metadonopløsninger med povidon K90, skal overgå til andre metadonlægemidler, der ikke medfører samme risiko for ophobning af povidon i vitale organer.
English: Methadone tablets containing low molecular weight povidone remain on the market, but their product information will be amended to reinforce the recommendation that these medicines are for oral administration only and must not be used in any other way.
Danish: Metadontabletter indeholdende lavmolekylært povidon vil fortsat være på markedet, men produktinformationen vil blive ændret med skærpelse af anvisningen om, at disse lægemidler kun er til oral administration og ikke må anvendes på anden måde.
English: • The risk of harm is reduced with low molecular weight povidone since it is expected to be readily excreted and not to accumulate inside cells.
Danish: • Risikoen for skader er mindre med lavmolekylært povidon, som forventes at udskilles let og ikke ophobes i cellerne.
English: The safety of oral methadone medicines containing povidone was reviewed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
Danish: EMA's Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) gennemgik sikkerheden af orale metadonlægemidler indeholdende povidon efter indberetninger om alvorlige bivirkninger hos tidligere eller nuværende stofmisbrugere i Norge, hvilket førte til suspendering af metadonholdige orale opløsninger indeholdende povidon K90 på det norske marked.
English: Oral methadone medicines are available as solutions or tablets, and should only be taken by mouth.
Danish: Orale metadonlægemidler fås som opløsninger og tabletter og må kun tages gennem munden.
English: • Because of the potential harm that could derive from such a misuse (injection into a vein), methadone solutions containing povidone K90 will be suspended.
Danish: • På grund af risikoen for skade ved et sådant misbrug (injektion i en vene) vil metadonopløsninger, der indeholder povidon K90, midlertidigt blive fjernet fra markedet.
English: The source of povidone could not be confirmed, but is likely to be methadone oral solution containing high molecular weight povidone following misuse by injection.
Danish: Kilden til povidon har ikke kunnet fastslås, men må formodes at være oral metadonopløsning indeholdende højmolkylært povidon, der er misbrugt til injektion.
English: Methadone is used in rehabilitation programs to prevent or reduce withdrawal symptoms in patients dependent on opioids such as heroin.
Danish: Metadon anvendes i rehabiliteringsforløb til at forebygge eller mindske abstinenssymptomer hos patienter, der er afhængige af opioider, såsom heroin.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented in all EU Member States where these medicines are marketed, according to an agreed timetable.
Danish: Da PRAC's anbefaling blev vedtaget enstemmigt af CMD(h), vil den nu i henhold til den vedtagne tidsplan blive gennemført i alle medlemsstater, hvor lægemidlerne markedsføres.
English: While these medicines are intended for oral use only, some patients may misuse oral methadone formulations by injecting them into a vein.
Danish: Sådanne lægemidler er udelukkende til oral brug, men kan af nogle patienter blive misbrugt ved indsprøjtning i en vene.
English: It followed the decision of NOMA, the Norwegian medicines agency, to suspend the only methadone-containing oral solution that contains high molecular weight povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Danish: Gennemgangen blev foretaget, efter at den norske lægemiddelstyrelse NOMA havde besluttet at suspendere den eneste orale metadonopløsning, der indeholder højmolekylært povidon, på det norske marked som følge af indberetninger om alvorlige bivirkninger hos tidligere og nuværende stofmisbrugere i Norge.
English: Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights.
Danish: Visse orale formuleringer af metadon indeholder hjælpestoffet povidon, der fås med forskellige molekylvægte.