FrancophonIA/ELRC3.0 huggingface dataset:
English: MS Contin 60 mg, tabletten met gereguleerde afgifte
Danish: MS Contin 60 mg, tabletten met gereguleerde afgifte 60 mg
English: OxyContin 10 mg, tabletten met gereguleerde afgifte
Danish: OxyContin 10 mg, tabletten met gereguleerde afgifte 10 mg
English: MORFINA LANNACHER 100 MG 100mg coated tablet
Danish: MORFINA LANNACHER 100 MG
English: PALLADONE SR CAPSULES 2MG 2 mg
Danish: PALLADONE SR CAPSULES 2MG
English: FILNARINE SR 60MG PROLONGED RELEASE TABLETS 60 mg
Danish: FILNARINE SR 60MG PROLONGED RELEASE TABLETS
English: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS 10 mg
Danish: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS
English: PALLADONE L.P. 4 mg, gélule à libération prolongée
Danish: 4 mg, gélule à libération prolongée
English: MST CONTINUS TABLETS 30MG 30 mg
Danish: MST CONTINUS TABLETS 30MG
English: PALLADONE SR CAPSULES 4MG 4 mg
Danish: PALLADONE SR CAPSULES 4MG
English: FILNARINE SR 10MG PROLONGED RELEASE TABLETS 10 mg
Danish: FILNARINE SR 10MG PROLONGED RELEASE TABLETS
English: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte 5 mg
Danish: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte
English: Skenan SR 200 mg, capsules met gereguleerde afgifte
Danish: Skenan SR 200 mg, capsules met gereguleerde afgifte 200 mg
English: 194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
Danish: D 92213 Saint-Cloud Cedex France
English: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée 30 mg
Danish: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée
English: ZOMORPH L.P. 40 mg, gélule à libération prolongée
Danish: 40 mg, gélule à libération prolongée
English: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem 4 mg
Danish: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem
English: PALLADONE L.P. 16 mg, gélule à libération prolongée
Danish: 16 mg, gélule à libération prolongée
English: ZOMORPH L.P. 120 mg, gélule à libération prolongée
Danish: 120 mg, gélule à libération prolongée
English: MS Contin 15 mg, tabletten met gereguleerde afgifte
Danish: MS Contin 15 mg, tabletten met gereguleerde afgifte 15 mg
English: Vendal retard 30 mg prolonged-release tablets
Danish: Vendal retard 30 mg prolonged-release tablets 30 mg
English: Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten 200 mg Prolonged-release tablet
Danish: Morphinhydrochlorid Lannacher retard 200 mgFilmtabletten
English: Targin 20mg/10 mg Prolongedrelease tablets
Danish: Targin 20mg/10 mg Prolonged-release tablets
English: FILNARINE SR 200MG PROLONGED RELEASE TABLETS 200 mg Prolonged-release tablet
Danish: FILNARINE SR 200MG PROLONGED RELEASE TABLETS
English: LULuxembourg
Danish: LU - Luxembourg
English: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte 10 mg
Danish: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte
English: Targin 5mg/2.5 mg Prolongedrelease tablets
Danish: Targin 5mg/2.5 mg Prolonged-release tablets
English: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS 100 mg Prolonged-release tablet
Danish: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS
English: M-Stada 60 mg Retardtabletten 60 mg
Danish: M-Stada 60 mg Retardtabletten
English: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte 20 mg
Danish: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte
English: PALLADONE L.P. 8 mg, gélule à libération prolongée
Danish: 8 mg, gélule à libération prolongée
English: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Danish: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem
English: ZOMORPH L.P. 20 mg, gélule à libération prolongée
Danish: 20 mg, gélule à libération prolongée
English: Skenan SR 10 mg, capsules met gereguleerde afgifte
Danish: Skenan SR 10 mg, capsules met gereguleerde afgifte 10 mg
English: Relimal 200 mg Retardtabletten 200 mg Prolonged-release tablet
Danish: Relimal 200 mg Retardtabletten
English: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Danish: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem
English: PALLADONE L.P. 24 mg, gélule à libération prolongée
Danish: 24 mg, gélule à libération prolongée 24 mg
English: ZOMORPH L.P. 60 mg, gélule à libération prolongée
Danish: 60 mg, gélule à libération prolongée
English: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS 30 mg
Danish: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS
English: KAPANOL L.P. 100 mg, gélule à libération prolongée
Danish: 100 mg, gélule à libération prolongée
English: KAPANOL L.P. 50 mg, gélule à libération prolongée
Danish: 50 mg, gélule à libération prolongée
English: MST 200 mg Mundipharma 200 mg Prolonged-release tablet
Danish: MST 200 mg Mundipharma 200 mg
English: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Danish: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem
English: MORPHINE STADA L.P. 200 mg, comprimé pelliculé à libération prolongée
Danish: 200 mg, comprimé pelliculé à libération prolongée
English: 194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
Danish: F- 78550 Houdan 194 Bureaux de la CollineBâtiment D, 92213 Saint-Cloud CEDEX
English: Kapanol 100, capsules met gereguleerde afgifte 20 mg 100 mg Prolonged-release capsule Oral use
Danish: Kapanol 100, capsules met gereguleerde afgifte 20 mg
English: • The maximum dose should not exceed 2 g per day.
Danish: • Den maksimale dosis bør ikke overstige 2 g dagligt.
English: Therefore, oral vancomycin should no longer be used in these indications.
Danish: Derfor bør oral vancomycin ikke længere anvendes i disse indikationer.
English: • Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Danish: • Patienter, der har spørgsmål til deres behandling, bør tale med deres læge eller apotekspersonalet.
English: Vancomycin capsules
Danish: Vancomycin-kapsler
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/09/2017.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 21. september 2017.
English: The review of vancomycin-containing medicines was initiated on 1 April 2016 at the request of the Spanish medicines agency (AEMPS), under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af vancomycinholdige lægemidler blev indledt den 1. april 2016 på anmodning fra den spanske lægemiddelstyrelse (AEMPS), jf. artikel 31 i direktiv 2001/83/EF.
English: Changes aim to ensure appropriate use in context of fight against antimicrobial resistance
Danish: Ændringen har til formål at sikre hensigtsmæssig anvendelse i forbindelse med bekæmpelse af antimikrobiel resistens
English: Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.
Danish: Vancomycinholdige lægemidler har været godkendt nationalt i EU i mange år under navnet Vancocin og en række andre navne.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som vedtog agenturets udtalelse.
English: • The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Danish: • Den tilgængelige information om vancomycin er blevet gennemgået, og der er udstedt anbefalinger om sikker brug og hensigtsmæssig dosering af stoffet.
English: Vancomycin is one of a group of antibiotics known as glycopeptides.
Danish: Vancomycin tilhører en gruppe antibiotika, der kaldes glykopeptider.
English: • In patients with inflammatory intestinal disorders, the serum concentration of vancomycin after oral administration should be closely monitored.
Danish: • Hos patienter med inflammatoriske tarmsygdomme bør serumkoncentrationen af vancomycin overvåges nøje efter oral administration.
English: On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.
Danish: Den 19. maj 2017 anbefalede Det Europæiske Lægemiddelagentur en række ændringer af ordinationsoplysningerne for det antibiotiske stof vancomycin for at sikre hensigtsmæssig anvendelse ved behandling af alvorlige infektioner forårsaget af gram-positive bakterier.
English: EMA recommends changes to prescribing information for vancomycin antibiotics
Danish: EMA anbefaler ændring af ordinationsoplysningerne for vancomycin-antibiotika
English: • Any subsequent dose adjustments should be based on serum concentrations to achieve the target therapeutic concentrations.
Danish: • Efterfølgende doser bør baseres på serumkoncentrationer for at opnå de terapeutiske målkoncentrationer.
English: • The product information for medicines containing vancomycin will be updated to take these recommendations into account.
Danish: • Produktinformationen for lægemidler, der indeholder vancomycin, vil blive opdateret med henblik på at afspejle disse anbefalinger.
English: When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).
Danish: Når det tages gennem munden, bør brugen begrænses til behandling af Clostridium difficile-infektioner (CDI).
English: Available data showed that the previously recommended daily dose often resulted in suboptimal vancomycin serum concentrations.
Danish: De tilgængelige data viser, at den tidligere anbefalede daglige dosis ofte medfører suboptimale serumkoncentrationer af vancomycin.
English: In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient.
Danish: Derudover gennemgik udvalget den anbefalede dosering af vancomycin i de forskellige indikationer og patientgrupper og konkluderede, at startdosen af vancomycin ved infusion bør beregnes ud fra patientens alder og vægt.
English: Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance1.
Danish: Vancomycin er blevet anvendt siden 1950'erne, og det er fortsat den dag i dag en vigtig terapeutisk behandlingsmulighed i tilfælde af alvorlige infektioner.Agenturets Udvalg for Lægemidler til Mennesker (CHMP) gennemgik de tilgængelige data om vancomycinlægemidler givet som infusion (drop) og injektion samt taget gennem munden som led i sin strategi for opdatering af produktinformationen for gamle antibakterielle stoffer i forbindelse bekæmpelse af antimikrobiel resistens1.
English: For younger children, the use of age-appropriate formulations is recommended.
Danish: Behandling af yngre patienter bør ske ved anvendelse af aldersrelevante formuleringer.
English: Information for healthcare professionals The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin.
Danish: Agenturets anbefalinger er baseret på en gennemgang af de tilgængelige farmakologiske og kliniske data om vancomycin.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2017 EMA/645879/2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: • Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments.
Danish: • Vancomycin er et antibiotikum, der anvendes mod alvorlige infektioner, som ofte er forårsaget af bakterier, der er blevet resistente over for andre behandlinger.
English: • Vancomycin capsules can be used in patients aged 12 years and older for the treatment of CDI.
Danish: • Vancomycin-kapsler kan tages af patienter i alderen 12 år og opefter til behandling af CDI.
English: The CHMP concluded that infusion of vancomycin can continue to be used for the treatment of serious infections caused by certain bacteria including MRSA (meticillin-resistant Staphylococcus aureus) in patients of all ages.
Danish: CHMP konkluderede, at infusion af vancomycin fortsat kan anvendes til behandling af alvorlige infektioner forårsaget af visse bakterier, herunder MRSA (methicillin-resistent Staphylococcus aureus), hos patienter i alle aldre.
English: It can also be taken by mouth (as capsules or liquid) to treat an infection of the lining of the gut caused by bacteria called Clostridium difficile.
Danish: Det kan også tages gennem munden (som kapsler eller væske) for at behandle en infektion i tarmslimhinden, som skyldes bakterien Clostridium difficile.
English: The updated recommendations are based on data which showed that the previously recommended dose often resulted in less than optimal levels of vancomycin in the blood, reducing the effectiveness of the antibiotic.
Danish: De opdaterede anbefalinger er baseret på data, der viser, at den tidligere anbefalede dosis ofte medfører en suboptimal blodkoncentration af vancomycin, hvilket mindsker virkningen af antibiotikummet.
English: Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.
Danish: Da de tilgængelige data ikke i tilstrækkelig grad understøtter brugen af vancomycin til behandling af Staphylococcus enterocolitis (tarmbetændelse forårsaget af S. aureus) og til at fjerne bakterier i tarmen hos patienter med et svækket immunforsvar, konkluderede CHMP, at vancomycin ikke længere bør anvendes i disse indikationer.
English: It is given as an infusion (drip) into a vein or by injection in the abdomen (belly).
Danish: Det gives som en infusion (drop) i en blodåre eller som injektion i maven.
English: • Vancomycin solution for infusion can be used in patients of all ages for the treatment of complicated soft-tissue infections, bone and joint infections, community- and hospital-acquired pneumonia (including ventilator-associated pneumonia), infective endocarditis, acute bacterial meningitis, and bacteraemia associated with the above infections.
Danish: • Vancomycin som infusionsvæske, opløsning, kan anvendes hos patienter i alle aldre til behandling af komplicerede infektioner i blødt væv, knogle- og ledinfektioner, samfunds- og hospitalserhvervet lungebetændelse (herunder ventilationsrelateret lungebetændelse), infektiøs endokarditis, akut bakteriel meningitis og bakteriæmi, der har sammenhæng med ovennævnte infektioner.
English: • The recommended starting dose of vancomycin solution for infusion should be based on the age and weight of the patient.
Danish: • Den anbefalede startdosis af vancomycin som infusionsvæske, opløsning, bør baseres på patientens alder og vægt.
English: It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.
Danish: Det kan også bruges til perioperativ profylakse hos patienter med risiko for at udvikle bakteriel endokarditis og til behandling af peritonealdialyse-relateret peritonitis.
English: It is given by infusion (drip) into a vein to treat serious infections due to Gram-positive bacteria such as meticillin-resistant Staphylococcus aureus (MRSA) that are resistant to other antibiotics, or in patients in whom other antibiotics cannot be used.
Danish: Det gives som infusion (drop) i en blodåre til behandling af patienter med alvorlige infektioner, der skyldes gram-positive bakterier (f.eks. methicillin-resistent Staphylococcus aureus (MRSA)), som er resistente over for andre antibiotika, eller til behandling af patienter, der ikke kan behandles med andre antibiotika.
English: • The available data do not adequately support the use of oral vancomycin in the treatment of staphylococcal enterocolitis and for the decontamination of the GI tract in immunocompromised patients.
Danish: • De tilgængelige data understøtter ikke i tilstrækkelig grad anvendelsen af oral vancomycin til behandling af Staphylococcus enterocolitis og til gastrointestinal dekontaminering hos immunkompromitterede patienter.
English: • Vancomycin parenteral formulations authorised for oral use can be used by mouth in patients of all ages for the treatment of Clostridium difficile infection (CDI).
Danish: • Vancomycin i parenterale formuleringer, der er godkendt til oral anvendelse, kan anvendes gennem munden hos patienter i alle aldre til behandling af Clostridium difficile-infektion (CDI).
English: Vancomycin is also given by mouth to treat infections caused by Clostridium difficile, which mostly develop in hospital patients treated with other antibiotics.
Danish: Vancomycin anvendes også gennem munden til at behandle infektioner forårsaget af Clostridium difficile, der typisk udvikles hos indlagte patienter, som behandles med andre antibiotika.
English: Vancomycin can also be used to prevent bacterial endocarditis (an infection in the heart) in patients undergoing surgery and to treat infections in patients undergoing a procedure called peritoneal dialysis.
Danish: Vancomycin kan også anvendes til at forebygge bakteriel endokarditis (en infektion i hjertet) hos patienter, der skal opereres, og til behandling af infektioner hos patienter, der skal i såkaldt peritoneal-dialyse.
English: The product information for vancomycin will be updated to reflect the following: Vancomycin solution for infusion
Danish: Produktinformationen for vancomycin vil blive opdateret for at afspejle følgende:
English: • Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.
Danish: • Vancomycin i parenterale formuleringer, der er godkendt til intraperitoneal anvendelse, kan anvendes hos patienter i alle aldre til behandling af peritonealdialyse-relateret peritonitis.
English: This summary was last updated in 11-2016.
Danish: Dette sammendrag blev sidst ajourført i 11-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan on 4 October 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Crixivan den 4. oktober 1996.
English: The full EPAR for Crixivan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Crixivan findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public indinavir
Danish: EPAR - sammendrag for offentligheden indinavir
English: This is a summary of the European public assessment report (EPAR) for Crixivan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Crixivan.
English: To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Danish: For at undgå risikoen for at udvikle nyresten skal patienter drikke rigeligt med væske (mindst 1,5 liter hver dag for voksne).
English: Other information about Crixivan
Danish: Andre oplysninger om Crixivan
English: The CHMP decided that Crixivan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Crixivan opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered sense of taste and abdominal pain (stomach ache).
Danish: De hyppigste bivirkninger ved Crixivan (som optræder hos mere end 1 ud af 10 patienter) er stigninger i røde blodcellers størrelse, fald i neutrofiler (en form for hvide blodceller), hovedpine, svimmelhed, kvalme, opkastning, diarré, dyspepsi (halsbrand), tilfælde af høje bilirubin-værdier, som ikke medfører nogen symptomer), stigning i antallet af leverenzymer (alanin og aspartat-aminotransferase), udslæt, tør hud, hæmaturi (blod i urinen), proteinuri (protein i urinen), krystaller i urinen, asteni (svækkelse) eller træthed, smagsforandring og mavesmerter.
English: The standard dose is 800 mg every eight hours, but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine).
Danish: Standarddosis er 800 mg hver 8. time, men Crixivan kan også tages i en dosis på 400 mg to gange om dagen, hvis hver dosis tages med 100 mg ritonavir (et andet antiviralt lægemiddel).
English: What measures are being taken to ensure the safe and effective use of Crixivan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Crixivan?
English: It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Danish: Det blokerer et enzym kaldet protease, der medvirker ved formeringen af hiv.
English: Crixivan must not be taken with certain other medicines because of the possibility of harmful interactions.
Danish: Crixivan må ikke tages sammen med visse andre lægemidler pga. muligheden for skadelige vekselvirkninger.
English: Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.
Danish: Crixivan bør udskrives af læger med erfaring i behandling af hiv, og det kan kun fås på recept.
English: The active substance in Crixivan, indinavir, is a protease inhibitor.
Danish: Det aktive stof i Crixivan, indinavir, er en proteasehæmmer.
English: Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Crixivan helbreder ikke hiv-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two hours after a meal with water or a light low-fat meal.
Danish: Crixivan fås som kapsler (200 og 400 mg) og indtages gennem munden en time før eller to timer efter et måltid sammen med vand eller et let måltid med lavt fedtindhold.
English: What is Crixivan and what is it used for?
Danish: Hvad er Crixivan, og hvad anvendes det til?
English: Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster'.
Danish: Ritonavir, en anden protease-hæmmer, anvedes sommetider sammen med Crixivan som "booster".
English: By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.
Danish: Ved at blokere dette enzym kan indinavir forhindre virussen i at formere sig normalt og dermed forsinke spredningen af infektionen.
English: It is not intended to provide practical advice on how to use Crixivan.
Danish: Det er ikke en praktisk vejledning i, hvordan Crixivan bør anvendes.