FrancophonIA/ELRC3.0 huggingface dataset:
English: ODIN is a Phase III, randomised, open-label trial comparing PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Danish: ODIN er et randomiseret, åbent fase III-studie, der sammenligner PREZISTA/ritonavir 800/100 mg en gang dagligt med PREZISTA/ritonavir 600/100 mg to gange dagligt hos ART-erfarne hiv-1-inficerede patienter, hos hvem screening for genotype-resistens har vist, at der ikke fandtes darunavir RAMs (dvs. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), og screening for hiv-1RNA viste > 1.000 kopier/ml.
English: - Keep this leaflet.
Danish: Fjern det løse låg.
English: - Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Danish: Din læge vil muligvis foretage yderligere test - kortikosteroider, herunder betamethason, budesonid, fluticason, mometason, prednison, triamcinolon.
English: Caution should be exercised when clarithromycin is combined with PREZISTA co-administered with low dose ritonavir.
Danish: Der skal udvises forsigtighed, når clarithromycin kombineres med PREZISTA administreret sammen med lavdosis ritonavir.
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of PREZISTA/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Danish: ART-erfarne pædiatriske patienter i alderen 3 til < 6 år Farmakokinetik, sikkerhed, tolerabilitet og virkning af PREZISTA/ritonavir to gange dagligt i kombination med andre antiretrovirale lægemidler hos 21 ART-erfarne hiv-1 smittede pædiatriske patienter i alderen 3 til < 6 år med en legemsvægt på 10 kg til < 20 kg blev evalueret i et åbent fase IIstudie, ARIEL.
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using PREZISTA/ritonavir, interruption or discontinuation of treatment should be considered promptly.
Danish: Ved nye tilfælde eller forværring af leverdysfunktion (med klinisk signifikant forhøjelse af leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørkfarvning af urin, ømhed over leveren, hepatomegali) hos patienter, der anvender PREZISTA/ritonavir, bør det overvejes omgående at seponere behandlingen eller indstille den midlertidigt.
English: The film-coating contains poly(vinyl alcohol) - partially hydrolysed, macrogol 3350, titanium dioxide (E171), talc, sunset yellow FCF (E110).
Danish: Filmovertrækket indeholder polyvinylalkohol - delvist hydrolyseret, macrogol 3350, titandioxid (E171), talcum, sunset yellow FCF (E110).
English: Alternative or additional contraceptive measures are recommended when oestrogen-based contraceptives are co-administered with boosted PREZISTA.
Danish: Det anbefales at bruge andre eller supplerende svangerskabsforebyggende metoder, når østrogenbaserede kontraceptiva gives sammen med boostet PREZISTA.
English: PREZISTA with low dose ritonavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Danish: PREZISTA med lavdosis ritonavir med triazolam eller oral midazolam er kontraindiceret (se pkt.
English: Therefore, co-administration of boosted PREZISTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Danish: Co-administration af boostet PREZISTA og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt.
English: Concomitant use of boosted PREZISTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Samtidig brug af boostet PREZISTA og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyresuppression.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with PREZISTA and low dose ritonavir has not been established.
Danish: En sikker og effektiv dosis af sildenafil til behandling af pulmonal arteriel hypertension administreret sammen med PREZISTA og lavdosis ritonavir er ikke fastlagt.
English: If concomitant use of PREZISTA co-administered with low dose ritonavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Danish: Hvis samtidig brug af sildenafil, vardenafil eller tadalafil og PREZISTA administreret sammen med lavdosis ritonavir er indiceret, anbefales det at give en enkeltdosis sildenafil på højst 25 mg i løbet af 48 timer, en enkeltdosis vardenafil på højst 2,5 mg i løbet af 72 timer eller en enkeltdosis tadalafil på højst 10 mg i løbet af 72 timer.
English: Co-administration of PREZISTA co-administered with cobicistat and bosentan is not recommended.
Danish: Co-administration af PREZISTA co-administreret med cobicistat og bosentan frarådes.
English: Concomitant use of colchicine and darunavir co-administered with low dose ritonavir may increase the exposure to colchicine.
Danish: Samtidig anvendelse af cochicin og darunavir administreret sammen med lavdosis ritonavir kan øge eksponeringen for colchicin.
English: 240 film-coated tablets
Danish: 240 filmovertrukne tabletter
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Danish: ART-erfarne pædiatriske patienter (3 til 17 år og legemsvægt mindst 40 kg) Hos ART-erfarne patienter, der ikke har DRV-RAMs*, og som har plasma-hiv-1-RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
English: Co-administration of PREZISTA with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Danish: Co-administration af PREZISTA med disse antikoagulantia kan øge koncentrationerne af antikoagulanset, hvilket kan medføre en øget blødningsrisiko.
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by boosted PREZISTA.
Danish: Alfentanil metaboliseres via CYP3A og kan dermed hæmmes af boostet PREZISTA.
English: If HIV-1 genotype testing is not available, the recommended dose regimen is PREZISTA 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Danish: Hvis der ikke foreligger bestemmelse af hiv-1-genotypen, er den anbefalede dosis PREZISTA 600 mg to gange dagligt sammen med ritonavir 100 mg to gange dagligt i forbindelse med et måltid.
English: Darunavir binds primarily to plasma α1-acid glycoprotein.
Danish: Darunavir binder sig især til plasma 1-syre glycoprotein.
English: PREZISTA 400 mg or 800 mg must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Danish: PREZISTA 400 mg eller 800 mg skal altid gives oralt sammen med cobicistat eller lavdosis ritonavir som farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler (se pkt.
English: - stiffness of muscles or joints, joint pain with or without inflammation - changes in some values of your blood cells or chemistry.
Danish: - snue - beskadigelse af huden, tør hud - stive muskler eller led, ledsmerter med eller uden betændelse - ændringer i visse blodlegemer eller i blodets kemiske sammensætning.
English: PREZISTA cannot work properly without ritonavir.
Danish: PREZISTA virker ikke korrekt uden ritonavir.
English: Therefore, PREZISTA tablets should be taken with ritonavir and with food.
Danish: PREZISTA skal derfor tages med ritonavir og med mad.
English: PREZISTA co-administered with low dose ritonavir must not be used concomitantly with products containing St John's wort (Hypericum perforatum) (see section 4.3).
Danish: PREZISTA administreret sammen med lavdosis ritonavir må ikke anvendes samtidig med produkter, der indeholder perikon (Hypericum perforatum) (se pkt.
English: Dark red oval shaped tablet of 20.0 mm, debossed with “800” on one side and “T” on the other side.
Danish: Mørkerød, oval tablet på 20,0 mm med ”800” præget på den ene side og ”T” præget på den anden side.
English: Boceprevir 800 mg three times daily boceprevir AUC ↓ 32% boceprevir Cmin ↓ 35% boceprevir Cmax ↓ 25% darunavir AUC ↓ 44% darunavir Cmin ↓ 59% darunavir Cmax ↓ 36%
Danish: boceprevir AUC ↓ 32 % boceprevir Cmin ↓ 35 % boceprevir Cmax ↓ 25 % darunavir AUC ↓ 44 % darunavir Cmin ↓ 59 % darunavir Cmax ↓ 36 %
English: Pack size of one bottle or three bottles per carton.
Danish: Pakningsstørrelse: 1 eller 3 tabletbeholdere pr. karton.
English: Put the oral dosing pipette back together after air drying and store with the PREZISTA bottle.
Danish: Efter lufttørring skal doseringssprøjten samles igen og opbevares sammen med flasken med PREZISTA.
English: If parenteral midazolam is co-administered with boosted PREZISTA it may cause a large increase in the concentration of this benzodiazepine.
Danish: Co-administration af parenteral midazolam med boostet PREZISTA kan give en kraftig forøgelse af koncentrationen af dette benzodiazepin.
English: Insert the supplied oral dosing pipette all the way into the bottle.
Danish: Tryk den vedlagte doseringssprøjte helt ned i flasken.
English: Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The doctor will work out the right dose based on the weight of the child (see table below).
Danish: Dosis til børn fra 3 år og opefter med en legemsvægt på mindst 15 kg, som tidligere har fået medicin mod hiv-infektion (barnets læge vil afgøre dette) Lægen vil beregne den korrekte dosis på grundlag af barnets vægt (se tabellen nedenfor).
English: PREZISTA 800 mg film-coated tablets EU/1/06/380/007 - 30 film-coated tablets EU/1/06/380/008 - 90 film-coated tablets (3 x 30)
Danish: PREZISTA 800 mg filmovertrukne tabletter EU/1/06/380/007 - 30 filmovertrukne tabletter EU/1/06/380/008 - 90 filmovertrukne tabletter (3 x 30)
English: At week 48, the virologic response, defined as the percentage of patients with confirmed plasma viral load < 50 HIV-1 RNA copies/ml, was evaluated in 16 paediatric patients 15 kg to < 20 kg and 5 paediatric patients 10 kg to < 15 kg receiving PREZISTA/ritonavir in combination with other antiretroviral agents (see section 4.2 for dosage recommendations per body weight).
Danish: Ved uge 48 blev det virologiske respons, defineret som procentdelen af patienter med bekræftet viral load i plasma < 50 HIV-1 RNA kopier/ml, evalueret hos 16 pædiatriske patienter med legemsvægt 15 kg til < 20 kg og hos 5 pædiatriske patienter med legemsvægt 10 kg til < 15 kg, der fik PREZISTA/ritonavir i kombination med andre antiretrovirale lægemidler (se pkt.
English: Clinical monitoring is recommended when co-administering PREZISTA with low dose ritonavir and clonazepam.
Danish: Klinisk monitorering anbefales, når boostet PREZISTA administreres sammen med lavdosis ritonavir og clonazepam.
English: It is not recommended to co-administer boosted PREZISTA with glecaprevir/pibrentasvir.
Danish: Det frarådes at co-administrere boostet PREZISTA og glecaprevir/pibrentasvir.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon, magnesiumstearat.
English: Concomitant administration of boosted PREZISTA with dabigatran or ticagrelor is contraindicated (see section 4.3).
Danish: Samtidig administration af boostet PREZISTA og dabigatran eller ticagrelor er kontraindiceret (se pkt.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with boosted PREZISTA has not been established.
Danish: En sikker og effektiv dosis af sildenafil til behandling af pulmonal arteriel hypertension administreret sammen med boostet PREZISTA er ikke fastlagt.
English: PREZISTA co-administered with low dose ritonavir can be expected to increase the plasma concentrations of calcium channel blockers.
Danish: PREZISTA, co-administereret med lavdosis ritonavir kan forventes at øge plasmakoncentrationen af calciumantagonisterne.
English: (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition)
Danish: (↑ clarithromycin fra CYP3A-hæmning og mulig P-gp-hæmning (P-glykoprotein))
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 15 kg) PREZISTA twice daily taken with ritonavir taken with food is usually recommended.
Danish: ART-erfarne pædiatriske patienter (3 til 17 år og legemsvægt mindst 15 kg) Det anbefales sædvanligvis at tage PREZISTA to gange dagligt med ritonavir i forbindelse med et måltid.
English: Skin and subcutaneous tissue disorders very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Danish: meget almindelig udslæt (herunder makulært, makulopapulært, papulært, erytematøst, pruritisk udslæt, generaliseret udslæt og allergisk dermatitis)
English: Excipient with known effect: Each tablet contains 0.834 mg sunset yellow FCF (E110).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 0,834 mg sunset yellow FCF (E110).
English: Non-inferiority in virologic response to the PREZISTA/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Danish: Non-inferioritet i virologisk respons over for PREZISTA/ritonavir-behandlingen, defineret som procentdelen af patienter med plasma-hiv-1-RNA-niveau < 50 kopier/ml, blev påvist (ved den forud definerede 12 % grænse for non-inferioritet) hos begge populationer (”Intent-To-Treat” og ”On Protocol”) i analysen ved uge 48.
English: Boosted PREZISTA may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole or fluconazole may increase darunavir concentrations.
Danish: Boostet PREZISTA kan øge plasmakoncentrationen af antimykotika , og posaconazol, isavuconazol, itraconazol og fluconazol kan øge koncentrationen af darunavir.
English: Co-administration of boosted PREZISTA and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Danish: Co-administration af boostet PREZISTA og amiodaron, bepridil, dronedaron, ivabradin, kinidin eller ranolazin er kontraindiceret (se pkt.
English: PREZISTA, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight (see section 4.2).
Danish: PREZISTA, administreret sammen med lavdosis ritonavir, er i kombination med andre antiretrovirale lægemidler indiceret til behandling af human immundefektvirus (hiv-1)-infektion hos voksne og pædiatriske patienter fra 3 år med en legemsvægt på mindst 15 kg (se pkt.
English: Patients co-infected with hepatitis B and/or hepatitis C virus Among 1,968 treatment-experienced patients receiving PREZISTA co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Danish: Patienter co-inficeret med hepatitis B- og/eller hepatitis C-virus Blandt 1.968 behandlingserfarne patienter, der fik PREZISTA, co-administreret med ritonavir 600/100 mg to gange dagligt, havde 236 patienter også hepatitis B eller C. Disse patienter havde en større risiko for forhøjelse af hepatisk aminotransferase ved baseline og efter behandlingsstart end patienter uden kronisk viral hepatitis (se pkt.
English: Amber-coloured multiple-dose glass bottle for 200 ml suspension with a polypropylene closure with LDPE liner packaged with a 6 ml oral dosing pipette with 0.2 ml gradations.
Danish: Ravfarvet flerdosisglasflaske til 200 ml suspension med polypropylenprop foret med lavdensitetspolypropylen (LDPE) og vedlagt en 6 ml doseringssprøjte med målestreger for hver 0,2 ml.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, hypromellose.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidon, magnesiumstearat, hypromellose.
English: The Summary of Product Characteristics of ritonavir must, therefore, be consulted prior to initiation of therapy with PREZISTA.
Danish: Produktresuméet for ritonavir skal derfor læses, inden behandling med PREZISTA påbegyndes.
English: Saquinavir 1,000 mg twice daily darunavir AUC ↓ 26% darunavir Cmin ↓ 42% darunavir Cmax ↓ 17% saquinavir AUC ↓ 6% saquinavir Cmin ↓ 18% saquinavir Cmax ↓ 6%
Danish: darunavir AUC ↓ 26 % darunavir Cmin ↓ 42 % darunavir Cmax ↓ 17 % saquinavir AUC  6 % saquinavir Cmin 18 % saquinavir Cmax 6 %
English: Exposure to these immunosuppressants will be increased when co-administered with PREZISTA co-administered with low dose ritonavir.
Danish: Eksponeringen for disse immunsuppresiva vil øges ved samtidig administration af PREZISTA og lavdosis ritonavir.
English: Concomitant use of darunavir/ritonavir and darunavir/cobicistat with lopinavir/ritonavir, rifampicin and herbal products containing St John's wort, Hypericum perforatum, is contraindicated (see section 4.5).
Danish: Samtidig brug af darunavir/ritonavir og darunavir/cobicistat med lopinavir/ritonavir, rifampicin og naturlægemidler, som indeholder perikon, Hypericum perforatum, er kontraindiceret (se pkt.
English: Remove the plunger from the barrel of the pipette, rinse both with water and allow to air dry after each use.
Danish: Fjern stemplet fra selve sprøjten og skyl begge dele med vand.
English: Concominant use of everolimus or irinotecan and boosted PREZISTA is not recommended.
Danish: Samtidig brug af everolimus eller irinotecan og boostet PREZISTA frarådes.
English: PREZISTA 75 mg, 150 mg, 300 mg, and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):
Danish: PREZISTA 75 mg, 150 mg, 300 mg og 600 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer (se pkt.
English: It is not recommended to co-administer boosted PREZISTA and simeprevir.
Danish: Det frarådes at co-administrere boostet PREZISTA og simeprevir.
English: ANTIBIOTIC Clarithromycin 500 mg twice daily clarithromycin AUC ↑ 57% clarithromycin Cmin ↑ 174% clarithromycin Cmax ↑ 26% darunavir AUC ↓ 13% darunavir Cmin ↑ 1% darunavir Cmax ↓ 17% 14-OH-clarithromycin concentrations were not detectable when combined with PREZISTA/ritonavir.
Danish: clarithromycin AUC ↑ 57 % clarithromycin Cmin ↑ 174 % clarithromycin Cmax ↑ 26 % darunavir AUC  13 % darunavir Cmin  1 % darunavir Cmax  17 % 14-OH-clathromycin-koncentrationenerne var ikke målbare ved kombination med PREZISTA/ritonavir.
English: HIV-1 RNA < 50 copies/ml With Baseline HIV-1 RNA (copies/ml)
Danish: Hiv-1 RNA < 50 kopier/ml Med hiv-1-RNA (kopier/ml) ved baseline
English: The clinical trial data from ART-experienced patients (TITAN trial and the pooled analysis of the POWER 1, 2 and 3 and DUET 1 and 2 trials) showed that virologic response to PREZISTA co-administered with low dose ritonavir was decreased when 3 or more darunavir RAMs (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) were present at baseline or when these mutations developed during treatment.
Danish: De kliniske studiedata fra ART-erfarne patienter (TITAN-studiet og den samlede analyse af studierne POWER 1, 2 og 3 samt DUET 1 og 2) viste, at det virologiske respons på PREZISTA, når det gives sammen med lavdosis ritonavir, blev nedsat ved tilstedeværelse af 3 eller flere darunavir-RAMs (V11I, V32I, L33F, I47V, I50V, I54L eller M, T74P, L76V, I84V og L89V) ved baseline eller ved udvikling af disse mutationer i løbet af behandlingen.
English: Therefore, PREZISTA tablets should be taken with cobicistat or ritonavir and with food.
Danish: PREZISTA skal derfor tages med cobicistat eller ritonavir og med mad.
English: The Summary of Product Characteristics of cobicistat or ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with PREZISTA.
Danish: Produktresuméet for cobicistat eller ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med PREZISTA påbegyndes.
English: Concomitant use of PREZISTA with low dose ritonavir and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Samtidig brug af PREZISTA og lavdosis ritonavir og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyresuppression.
English: • ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Danish: ● som er ART-erfarne uden mutationer associeret med darunavirresistens (DRV-RAMs), og som har plasma hiv-1-RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with boosted PREZISTA.
Danish: Der skal udvises forsigtighed, og om muligt anbefales monitorering af terapeutisk koncentration for disse antiarytmika ved coadministration med boostet PREZISTA.
English: PREZISTA co-administered with low dose ritonavir and amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine is contraindicated (see section 4.3).
Danish: PREZISTA co-administreret med lavdosis ritonavir og amiodaron, bepridil, dronedaron, ivabradin, kinidin eller ranolazin er kontraindiceret (se pkt.
English: The PREZISTA 400 milligram tablet is not for use in children younger than 3 years of age or weighing less than 40 kilograms.
Danish: Børn og unge PREZISTA 400 mg tabletten må ikke anvendes til børn under 3 år, eller som vejer mindre end 40 kg.