natgillin/translations-raw huggingface dataset:
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/148/004 
MARKETING AUTHORISATION NUMBERS EU/1/00/148/004
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/148/003 
MARKETING AUTHORISATION NUMBER EU/1/00/148/003
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/00/148/002 
MARKETING AUTHORISATION NUMBER EU/1/00/148/002
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 480 bløde kapsler 
480 soft capsules
Det kan være nødvendigt med blodprøver for at kontrollere leverfunktionen. 
The dose of amprenavir may need adjusting.
Lever og galdeveje 
Driving and using machines
Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesveje og indehavere af markedsføringstilladelse i medlemsstaterne (EU/EØS) 
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states (EU/EEA)
PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1 
MUNDIPHARMA PHARMACEUTICALS S.L.Edificio Alvento (Torre D) Vía de los Poblados, 1
UK - Storbritannien 
UK - United Kingdom
S.A.Pº de Las Doce Estrellas, 57 28042 MADRID Spain 
S.A.Pº de Las Doce Estrellas, 5 - 7 28042 MADRID
RO - Rumænien 
RO - Romania
LV - Letland 
LV - Latvia
CZ - Tjekkiet 
CZ - Czech Republic
LT - Litauen 
LT - Lithuania
HU - Ungarn 
HU - Hungary
SI - Slovenien 
SI - Slovenia
BG - Bulgarien 
BG - Bulgaria
BE - Belgien 
BE - Belgium
SK - Slovakiet 
SK - Slovakia
EL- Grækenland 
EL-Greece
3 Obroncow Modlina St. 30-733, Cracow 
30-733, Cracow
12 rue du Sergent Bobillot 92400 Courbevoie 
ARCHIMEDES PHARMA FRANCE SARL 12 rue du Sergent Bobillot 92400 Courbevoie
Praça Duque de Saldanha, 1 - 6º - Edifício Atrium Saldanha, 1050 
Praça Duque de Saldanha, 1 - 6ºEdifício Atrium Saldanha, 1050-094 São Jorge de Arroios - Lisboa Portugal
Kapsel med modificeret udløsning 
Modified-release capsule
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton FR-92500 Rueil Malmaison France 
Laboratoires UPSA (Rueil Malmaison), 128, Rue Danton
AT - Østrig betapharm Arzneimittel GmbH Kobelweg 95 
AT - Austria betapharm Arzneimittel GmbH Kobelweg 95
Mundipharma Pharmaceuticals Ltd 
Napp Pharmaceuticals Ltd.
Granulat med kontrolleret udløsning til oral suspension 
Controlled release granules for oral suspension
Elisabeth-Selbert-Str. 1 D-40764 Langenfeld Germany 
D-40764 Langenfeld Germany
NL-1507 CC Zaandam Florapark 
NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien 
Albert-Schweitzer Gasse 3 1140 Wien
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW 
NAPP PHARMACEUTICALS LIMITED Cambridge Science Park, Milton Road, Cambridge CB4 0GW United Kingdom
Tablet med modificeret udløsning 
Modified release tablet
Depotgranulat til oral suspension 
Prolonged-release granules for oral suspension
Granulat med modificeret udløsningtil oral suspension 
Modified-release granules for oral suspension
Filmovertrukket depotkapsel, hård Oral anvendelse 
Prolonges release capsule, hard Oral use
Depotmikrogranuler i kapsel, hård 
Prolonged-release micropillules in hard capsule
Palladon retard 24 mg 24 mg 
Palladon retard 24 mg
NL - Holland 
The Netherlands
MSTW 30 mg Krugmann 30 mg 
MSTW 30 mg Krugmann
MSTW 10 mg Krugmann 10 mg 
MSTW 10 mg Krugmann
MST 30 mg Mundipharma 30 mg 
MST 30 mg Mundipharma
DOC MORFINE 100 MG 100 mg 
DOC MORFINE 100 MG
MST CONTINUS TABLETS 5MG 
MST CONTINUS TABLETS 5MG 5 mg
MST 10 mg Mundipharma 10 mg 
MST 10 mg Mundipharma
MSTW 60 mg Krugmann 60 mg 
MSTW 60 mg Krugmann
Carenox 10 mg Retardtabletten 
Carenox 10 mg Retardtabletten 10 mg
OXYCONTIN PR TABLETS 10mg 
OXYCONTIN PR TABLETS 10mg 10mg
ЕООД, ул. 
ул.
Oxycodonhydrochlorid - 1 A Pharma 10 mg Retardtabletten 
Oxycodonhydrochlorid - 1 A Pharma 10 mg Retardtabletten 10 mg
Filmovertrukket tablet Oral anvendelse 
Film-coated tablet
MUNDIPHARMA 
Pharmaceutical form
OXYCONTIN PR TABLETS 20mg 
OXYCONTIN PR TABLETS 20mg 20mg
OXYCONTIN PR TABLETS 80mg 
OXYCONTIN PR TABLETS 80mg 80mg
SE - Sverige ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany 
SE - Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten 
Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten 5 mg
13 Othellos street, P.O.Box 
Mundipharma Pharmaceuticals Ltd 13 Othellos street, P.O.Box 23661 1685 Lefkosia
MST 60 mg Mundipharma 60 mg 
MST 60 mg Mundipharma
LONGTEC 40 MG FILMCOATED, PROLONGED RELEASE TABLETS 
LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE TABLETS
Morphinhydrochlorid Lannacher retard 60 mgFilmtabletten 
Morphinhydrochlorid Lannacher retard 60 mg - Filmtabletten
OxyContin 5 mg, tabletten met gereguleerde afgifte 5 mg 
OxyContin 5 mg, tabletten met gereguleerde afgifte
LONGTEC 20 MG FILMCOATED, PROLONGED RELEASE TABLETS 
LONGTEC 20 MG FILM-COATED, PROLONGED RELEASE TABLETS
Filmovertrukket tablet med modificeret frigivelse 
Modified-release film-coated tablet
Depotkapsel, blød Oral anvendelse 
Prolonged-release capsule, soft Oral use
JURNISTA 4 mg Retardtabletten 
JURNISTA 4 mg Retardtabletten 4 mg
Morphinhydrochlorid Lannacher retard 10 mgFilmtabletten 
Morphinhydrochlorid Lannacher retard 10 mg - Filmtabletten
JURNISTA 8 mg Retardtabletten 
JURNISTA 8 mg Retardtabletten 8 mg
CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS 
CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS 5 mg
Morphinhydrochlorid Lannacher retard 100 mgFilmtabletten 
Morphinhydrochlorid Lannacher retard 100 mg - Filmtabletten
Kapsel med modificeret udløsning Oral anvendelse 
Prolonged-release capsule Oral use
LONGTEC 5 MG FILMCOATED, PROLONGED RELEASE TABLETS 
LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS 5 mg
PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem 
PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem 8 mg
M-Stada 10 mg Retardtabletten 
M-Stada 10 mg Retardtabletten 10 mg
M-Stada 30 mg Retardtabletten 
M-Stada 30 mg Retardtabletten 30 mg
PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem 
PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem 16 mg
MST CONTINUS TABLETS 10MG 
MST CONTINUS TABLETS 10MG 10 mg
Morphinhydrochlorid Lannacher retard 30 mgFilmtabletten 
Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten 30 mg
OxyContin 40 mg, tabletten met gereguleerde afgifte 40 mg 
OxyContin 40 mg, tabletten met gereguleerde afgifte
Morphinsulfat "Ethypharm" 40 mg 
Morphinsulfat "Ethypharm"
MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS 
MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS 5 mg
MORPHIN-PUREN 60 mg retard 
MORPHIN-PUREN 60 mg retard 60 mg
LONGTEC 80 MG FILMCOATED, PROLONGED RELEASE TABLETS 
LONGTEC 80 MG FILM-COATED, PROLONGED RELEASE TABLETS 80 mg
LONGTEC 10 MG FILMCOATED, PROLONGED RELEASE TABLETS 
LONGTEC 10 MG FILM-COATED, PROLONGED RELEASE TABLETS 10 mg
Overtrukket tablet Oral anvendelse 
Prolonged-release coated tablet Oral use
CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS 
CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS 40 mg
Vendal retard 60 mg prolonged-release tablets 60 mg 
Vendal retard 60 mg prolonged-release tablets
MS Contin 60 mg, tabletten met gereguleerde afgifte 60 mg 
MS Contin 60 mg, tabletten met gereguleerde afgifte
OxyContin 10 mg, tabletten met gereguleerde afgifte 10 mg 
OxyContin 10 mg, tabletten met gereguleerde afgifte
MORFINA LANNACHER 100 MG 
MORFINA LANNACHER 100 MG 100mg coated tablet
MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS 
MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS 10 mg
MST CONTINUS TABLETS 30MG 
MST CONTINUS TABLETS 30MG 30 mg
PALLADONE SR CAPSULES 4MG 
PALLADONE SR CAPSULES 4MG 4 mg
Skenan SR 200 mg, capsules met gereguleerde afgifte 200 mg 
Skenan SR 200 mg, capsules met gereguleerde afgifte
D 92213 Saint-Cloud Cedex France 
194 Bureaux de la Colline Batiment D 92213 Saint-Cloud Cedex France
PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem 
PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem 4 mg
MS Contin 15 mg, tabletten met gereguleerde afgifte 15 mg 
MS Contin 15 mg, tabletten met gereguleerde afgifte
Vendal retard 30 mg prolonged-release tablets 30 mg 
Vendal retard 30 mg prolonged-release tablets
Morphinhydrochlorid Lannacher retard 200 mgFilmtabletten 
Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten 200 mg Prolonged-release tablet
Targin 20mg/10 mg Prolonged-release tablets 
Targin 20mg/10 mg Prolongedrelease tablets
LU - Luxembourg 
LULuxembourg
Targin 5mg/2.5 mg Prolonged-release tablets 
Targin 5mg/2.5 mg Prolongedrelease tablets
MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS 
MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS 100 mg Prolonged-release tablet
M-Stada 60 mg Retardtabletten 
M-Stada 60 mg Retardtabletten 60 mg
Skenan SR 10 mg, capsules met gereguleerde afgifte 10 mg 
Skenan SR 10 mg, capsules met gereguleerde afgifte
24 mg, gélule à libération prolongée 24 mg 
PALLADONE L.P. 24 mg, gélule à libération prolongée
MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS 
MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS 30 mg
MST 200 mg Mundipharma 200 mg 
MST 200 mg Mundipharma 200 mg Prolonged-release tablet
F- 78550 Houdan 194 Bureaux de la CollineBâtiment D, 92213 Saint-Cloud CEDEX 
194 Bureaux de la Colline - Bâtiment D, 92213 Saint-Cloud CEDEX France
• Den maksimale dosis bør ikke overstige 2 g dagligt. 
• The maximum dose should not exceed 2 g per day.
Derfor bør oral vancomycin ikke længere anvendes i disse indikationer. 
Therefore, oral vancomycin should no longer be used in these indications.
• Patienter, der har spørgsmål til deres behandling, bør tale med deres læge eller apotekspersonalet. 
• Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Vancomycin-kapsler 
Vancomycin capsules
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. 
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.
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. 
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.
Ændringen har til formål at sikre hensigtsmæssig anvendelse i forbindelse med bekæmpelse af antimikrobiel resistens 
Changes aim to ensure appropriate use in context of fight against antimicrobial resistance
Vancomycinholdige lægemidler har været godkendt nationalt i EU i mange år under navnet Vancocin og en række andre navne. 
Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.
Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som vedtog agenturets udtalelse. 
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.
• Den tilgængelige information om vancomycin er blevet gennemgået, og der er udstedt anbefalinger om sikker brug og hensigtsmæssig dosering af stoffet. 
• The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Vancomycin tilhører en gruppe antibiotika, der kaldes glykopeptider. 
Vancomycin is one of a group of antibiotics known as glycopeptides.
• Hos patienter med inflammatoriske tarmsygdomme bør serumkoncentrationen af vancomycin overvåges nøje efter oral administration. 
• In patients with inflammatory intestinal disorders, the serum concentration of vancomycin after oral administration should be closely monitored.
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. 
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.
EMA anbefaler ændring af ordinationsoplysningerne for vancomycin-antibiotika 
EMA recommends changes to prescribing information for vancomycin antibiotics
• Efterfølgende doser bør baseres på serumkoncentrationer for at opnå de terapeutiske målkoncentrationer. 
• Any subsequent dose adjustments should be based on serum concentrations to achieve the target therapeutic concentrations.
• Produktinformationen for lægemidler, der indeholder vancomycin, vil blive opdateret med henblik på at afspejle disse anbefalinger. 
• The product information for medicines containing vancomycin will be updated to take these recommendations into account.
Når det tages gennem munden, bør brugen begrænses til behandling af Clostridium difficile-infektioner (CDI). 
When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).
De tilgængelige data viser, at den tidligere anbefalede daglige dosis ofte medfører suboptimale serumkoncentrationer af vancomycin. 
Available data showed that the previously recommended daily dose often resulted in suboptimal vancomycin serum concentrations.
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. 
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.
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. 
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.
Behandling af yngre patienter bør ske ved anvendelse af aldersrelevante formuleringer. 
For younger children, the use of age-appropriate formulations is recommended.
Agenturets anbefalinger er baseret på en gennemgang af de tilgængelige farmakologiske og kliniske data om vancomycin. 
Information for healthcare professionals The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin.
• Vancomycin er et antibiotikum, der anvendes mod alvorlige infektioner, som ofte er forårsaget af bakterier, der er blevet resistente over for andre behandlinger. 
• Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments.
• Vancomycin-kapsler kan tages af patienter i alderen 12 år og opefter til behandling af CDI. 
• Vancomycin capsules can be used in patients aged 12 years and older for the treatment of CDI.
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. 
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.
Det kan også tages gennem munden (som kapsler eller væske) for at behandle en infektion i tarmslimhinden, som skyldes bakterien Clostridium difficile. 
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.
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. 
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.
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. 
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.
Det gives som en infusion (drop) i en blodåre eller som injektion i maven. 
It is given as an infusion (drip) into a vein or by injection in the abdomen (belly).
• 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. 
• 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.
• Den anbefalede startdosis af vancomycin som infusionsvæske, opløsning, bør baseres på patientens alder og vægt. 
• The recommended starting dose of vancomycin solution for infusion should be based on the age and weight of the patient.
Det kan også bruges til perioperativ profylakse hos patienter med risiko for at udvikle bakteriel endokarditis og til behandling af peritonealdialyse-relateret peritonitis. 
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.
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. 
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.
• De tilgængelige data understøtter ikke i tilstrækkelig grad anvendelsen af oral vancomycin til behandling af Staphylococcus enterocolitis og til gastrointestinal dekontaminering hos immunkompromitterede patienter. 
• 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.
• 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). 
• 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).
Vancomycin anvendes også gennem munden til at behandle infektioner forårsaget af Clostridium difficile, der typisk udvikles hos indlagte patienter, som behandles med andre antibiotika. 
Vancomycin is also given by mouth to treat infections caused by Clostridium difficile, which mostly develop in hospital patients treated with other antibiotics.
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. 
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.
Produktinformationen for vancomycin vil blive opdateret for at afspejle følgende: 
The product information for vancomycin will be updated to reflect the following: Vancomycin solution for infusion
• Vancomycin i parenterale formuleringer, der er godkendt til intraperitoneal anvendelse, kan anvendes hos patienter i alle aldre til behandling af peritonealdialyse-relateret peritonitis. 
• Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.
Dette sammendrag blev sidst ajourført i 11-2016. 
This summary was last updated in 11-2016.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Crixivan den 4. oktober 1996. 
The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan on 4 October 1996.
Den fuldstændige EPAR for Crixivan findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Crixivan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
EPAR - sammendrag for offentligheden indinavir 
EPAR summary for the public indinavir
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Crixivan. 
This is a summary of the European public assessment report (EPAR) for Crixivan.
For at undgå risikoen for at udvikle nyresten skal patienter drikke rigeligt med væske (mindst 1,5 liter hver dag for voksne). 
To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Andre oplysninger om Crixivan 
Other information about Crixivan
CHMP konkluderede, at fordelene ved Crixivan opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse. 
The CHMP decided that Crixivan's benefits are greater than its risks and recommended that it be given marketing authorisation.
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. 
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).