FrancophonIA/ELRC3.0 huggingface dataset:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: De uønskede virkninger er præsenteret i rækkefølge efter faldende alvorlighed indenfor hver frekvensgruppering.
English: In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Danish: Hos nogle af disse patienter var hyperglykæmien af svær grad, og i nogle tilfælde var hyperglykæmien associeret med ketoacidose.
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion, som tidligere har haft andre infektioner i forbindelse med deres hiv-infektion, kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at antihiv-behandlingen er startet.
English: The bottle contains 144 g of oral powder.
Danish: Flasken indeholder 144 g oralt pulver.
English: The pharmacokinetic properties of nelfinavir have been evaluated in healthy volunteers and HIV-infected patients.
Danish: Nelfinavirs farmakokinetiske egenskaber er blevet evalueret hos raske frivillige og hos hiv-smittede patienter.
English: You can use the handle of the second scoop to scrape off the extra powder and make your scoop level (see picture below).
Danish: Du kan bruge håndtaget på den anden måleske til at skrabe det ekstra pulver af med og dermed få en strøgen skefuld (se nedenstående billede).
English: Resistance: Viral escape from nelfinavir can occure via viral protease mutations at amino acid positions 30, 88 and 90.
Danish: Resistens: Viralt udbrud fra nelfinavir kan forekomme via virale proteasemutationer i aminosyrepositioner 30, 88 og 90.
English: Alternatively, Viracept 50 mg/g oral powder may be taken instead.
Danish: Alternativt kan 50 mg/g oralt pulver indtages i stedet.
English: No drug interaction study has been performed for the coadministration of nelfinavir with benzodiazepines.
Danish: Der er ikke foretaget en undersøgelse af lægemiddelinteraktionen for samtidig administration af nelfinavir og benzodiazepiner.
English: Plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally and should therefore not be coadministered with nelfinavir.
Danish: Plasmakoncentrationen af midazolam forventes at være signifikant højere, når midazolam gives oralt, og midazolam bør derfor ikke administreres oralt samtidig med nelfinavir.
English: The estimated volumes of distribution in both animals and humans is 2-7 l/kg which exceeded total body water and suggests extensive penetration of nelfinavir into tissues.
Danish: Den beregnede fordelingsvolumen i både dyr og mennesker er 2-7 l/kg, som overstiger legemets vandfase, hvilket tyder på en stor
English: If indicated, elimination of unabsorbed nelfinavir should be achieved by emesis or gastric lavage.
Danish: Hvis det er indiceret bør det uabsorberede nelfinavir fjernes ved opkastning eller maveudskylning.
English: Food taken with Viracept
Danish: Føde indtaget med Viracept
English: During in vitro studies, cloned human cardiac potassium channels (hERG) were inhibited by high concentrations of nelfinavir and its active metabolite M8. hERG potassium channels were inhibited by 20 % at nelfinavir and M8 concentrations that are about four- to five-fold and seventy-fold, respectively, above the average free therapeutic levels in humans.
Danish: I in vitro studier blev klonede humane kaliumkanaler fra hjertevæv (hERG) hæmmet ved høje koncentrationer af nelfinavir og dets aktive metabolit M8. hERG-kaliumkanalerne blev hæmmet med 20 % ved koncentrationer af nelfinavir og M8, der var omkring henholdsvis fire til fem gange og halvfjerds gange over det gennemsnitlige, frie, terapeutiske niveau i mennesker.
English: Viracept can stop the pill from working, so you should use other contraception methods (such as condoms) while you are taking Viracept.
Danish: Viracept kan forhindre p-piller i at virke, så du skal bruge andre præventionsmetoder (som f.eks. kondom), mens du tager Viracept
English: The prescriber should advise the caregiver to carefully monitor increases in weight of the child to ensure that the appropriate total daily dose is taken.
Danish: Den ordinerende læge skal rådgive pårørende til nøje at overvåge stigninger i barnets vægt for at sikre, at en passende samlet daglig dosis indtages.
English: Clinical pharmacodynamic data: treatment with nelfinavir alone or in combination with other antiretroviral agents has been documented to reduce viral load and increase CD4 cell counts in HIV-1 seropositive patients.
Danish: Kliniske farmakodynamiske egenskaber: Det er dokumenteret, at behandling med nelfinavir alene eller i kombination med andre antiretrovirusmidler nedsætter virusbelastningen og øger CD4-celletællingen hos hiv-1-seropositive patienter.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Viracept, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Carefully monitor the increase in weight of your child to ensure the appropriate total daily dose is taken.
Danish: Overvåg nøje om barnets vægt stiger for at sikre, at den korrekte totale daglige dosis
English: VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
Danish: VIRACEPT 50 mg/g oralt pulver leveres i HDPE plastikflasker forsynet med børnesikrede polypropylenlåg med et polyethylenindlæg.
English: • Ketoconazole, itraconazole or fluconazole (for fungal infections)
Danish: • Ketoconazol, itraconazol eller fluconazol (mod svampeinfektioner)
English: If you are not sure, talk to your doctor or pharmacist before taking Viracept.
Danish: Hvis du er i tvivl, skal du tale med din læge eller apoteket, før du tager Viracept.
English: Nelfinavir reversibly binds to the active site of HIV protease and prevents cleavage of the polyproteins resulting in the formation of immature non-infectious viral particles.
Danish: Nelfinavir bindes reversibelt til den aktive del af hiv-protease og forebygger spaltning af polyproteiner, hvilket medfører dannelsen af umodne, ikke-smittende viruspartikler.
English: If nelfinavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Samtidig administration af nelfinavir og parenteralt midazolam bør foregå på en intensivafdeling eller et lignende sted, hvor nøje klinisk overvågning og passende medicinsk behandling kan foretages i tilfælde af respirationsdepression og/eller forlænget sedation.
English: An HIV isolate obtained from a patient receiving saquinavir therapy showed decreased susceptibility to saquinavir (7- fold) but did not demonstrate a concordant decrease in susceptibility to nelfinavir.
Danish: Et hiv-isolat fra en patient, som fik saquinavir, viste nedsat følsomhed overfor saquinavir (med en faktor 7), men ingen tilsvarende nedsættelse af følsomheden overfor nelfinavir.
English: Blue, oblong biconvex film-coated tablets.
Danish: Blå, aflange, biokonvekse, filmovertrukne tabletter.
English: Speak with your doctor if you have a history of liver disease.
Danish: Tal med din læge, hvis du tidligere har haft en leversygdom.
English: Of 19 patients for whom both phenotypic and genotypic analyses were performed on clinical isolates, 9 patients isolates showed reduced susceptibility (5- to 93-fold) to nelfinavir in vitro.
Danish: Af 19 patienter, hos hvem der blev foretaget både fænotypiske og genotypiske analyser på kliniske isolater, viste 9 isolater nedsat følsomhed (med en faktor 5 til 93) overfor nelfinavir in vitro.
English: • Combination anti-retroviral therapy may cause changes in body shape due to changes in fat distribution.
Danish: • Antiretroviral kombinationsbehandling kan forårsage ændringer i kropsformen på grund af ændringer i fedtfordelingen.
English: No dose adjustment for nelfinavir is recommended.
Danish: Dosisjustering for nelfinavir anbefales ikke.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Danish: Roche Pharma AG Emil- Barrell Strasse 1 D-79639 Grenzach / Wyhlen Tyskland
English: Caution should be used when co-administering other agents that induce CYP3A4.
Danish: Der bør udvises forsigtighed ved samtidig administration af andre forbindelser, som inducerer CYP3A4.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
Danish: Hvis behandlingen havde været seponeret, blev behandling med proteasehæmmere fortsat eller genoptaget i mere end halvdelen af de rapporterede tilfælde.
English: The recommended dose of VIRACEPT film-coated tablets to be administered TID to children aged 3 to 13 years is shown in the table below.
Danish: Den anbefalede dosis af VIRACEPT filmovertrukne tabletter til administration tre gange daglig til børn mellem 3 og 13 år er vist i tabellen nedenfor.
English: Absorption: after single or multiple oral doses of 500 to 750 mg (two to three 250 mg tablets) with food, peak nelfinavir plasma concentrations were typically achieved in 2 to 4 hours.
Danish: Absorption: Efter en enkelt eller multiple orale doser af 500 til 750 mg (to til tre 250 mg tabletter) indtaget sammen med føde blev peak-plasmakoncentrationerne for nelfinavir typisk opnået efter 2 til 4
English: The clinical relevance of relating in vitro measures to drug potency and clinical outcome has not been established.
Danish: Der er ikke etableret klinisk relevans for at relatere in vitro mål med lægemiddeleffekt og klinisk udfald.
English: VIRACEPT oral powder contains potassium.
Danish: VIRACEPT oralt pulver indeholder kalium.
English: Administration of 300 mg/kg/day resulted in an increased incidence of thyroid follicular cell adenoma.
Danish: Administration af 300 mg/kg/dag medførte øget hyppighed af follikulære celleadenomer i thyreoidea.
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Danish: Kombinationen kan medføre øget risiko for kardiovaskulære bivirkninger forbundet med salmeterol, herunder QT-forlængelse, palpitationer og sinustakykardi.
English: For children able to take tablets, VIRACEPT tablets may be administered instead of the oral powder (see Summary of Product Characteristics for VIRACEPT tablets).
Danish: Til børn, som kan tage tabletter, kan der gives VIRACEPT-tabletter i stedet for oralt pulver (se produktresumé for VIRACEPT-tabletter).
English: Combination antiretroviral therapy has been associated with metabolic abnormalities such asblood triglycerides increased, blood cholesterol increased, insulin resistance, hyperglycaemia and hyperlactaemia.
Danish: Antiretroviral kombinationsbehandling er blevet associeret med metaboliske abnormaliteter så som forhøjede triglycerider og kolesterol i blodet, insulinresistens, hyperglykæmi og hyperlaktæmi.
English: A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Danish: En højere risiko for lipodystrofi er blevet sat i forbindelse med individuelle faktorer, såsom højere alder, og med lægemiddelrelaterede faktorer, såsom længere antiretroviral behandlingstid og ledsagende metaboliske forstyrrelser.
English: Adverse reactions from clinical trials with nelfinavir
Danish: Bivirkninger fra kliniske studier med nelfinavir
English: Combination anti-retroviral therapy may cause changes in body shape due to changes in fat distribution.
Danish: Antiretroviral kombinationsbehandling kan forårsage ændringer i kropsformen på grund af ændringer i fedtfordelingen.
English: Cross resistance in vitro: HIV isolates obtained from 5 patients during nelfinavir therapy showed a 5- to 93-fold decrease in nelfinavir susceptibility in vitro when compared to matched baseline isolates but did not demonstrate a concordant decrease in susceptibility to indinavir, ritonavir, saquinavir or amprenavir in vitro.
Danish: Krydsresistens in vitro: Hiv-isolater fra 5 patienter i behandling med nelfinavir viste nedsættelse (med en faktor 5 til 93) af følsomheden overfor nelfinavir in vitro sammenlignet med matchede isolater ved baseline, men ingen tilsvarende nedsættelse af følsomheden overfor indinavir, ritonavir, saquinavir eller amprenavir in vitro.
English: Renal and hepatic impairment: there are no data specific for HIV positive patients with renal impairment and therefore specific dosage recommendations cannot be made (see section 4.4).
Danish: Nedsat nyre- og leverfunktion: Der findes ingen data specifikt for hiv-positive patienter med nyreinsufficiens, og der kan derfor ikke gives specifikke doseringsanbefalinger (se pkt.
English: Caution should be used when administering VIRACEPT to patients with impaired renal or hepatic function.
Danish: Der skal udvises forsigtighed ved administration af VIRACEPT til patienter med nedsat nyre- eller leverfunktion.
English: Table 2: Incidences of Adverse Reactions and marked laboratory abnormalities from the phase
Danish: Tabel 2: Forekomst af bivirkninger og tydelige laboratorie-abnormaliteter fra fase II- og III
English: BOTTLE LABEL TEXT
Danish: TEKST PÅ FLASKEETIKET
English: A 49 %-69 % increase was observed in AUC of nelfinavir in the hepatically impaired group (Child-Turcotte Classes A to C) compared to the healthy group.
Danish: Der blev set en stigning på 49 % - 69 % af nelfinavirs AUC i den leverpåvirkede gruppe (Child-Turcotte klasse A til C) sammenlignet med den raske gruppe.
English: A connection between visceral lipomatosis and PIs and lipoatrophy and nucleoside analogue reverse transcriptase inhibitors (NRTIs) has been hypothesised.
Danish: Det er blevet antaget, at der er en forbindelse mellem visceral lipomatose og PI samt mellem lipoatrofi og nukleosid reverse transskriptasehæmmere (NRTI).
English: Pharmacotherapeutic group: direct acting antivirals, ATC code: J05AE04
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale lægemidler, ATC kode: J05 A E04
English: Since nelfinavir is highly protein bound, dialysis is unlikely to significantly remove it from blood.
Danish: Da nelfinavir er kraftigt proteinbundet er det ikke sandsynligt at dialyse kan fjerne det fra blodet i væsentlig grad.
English: Measure out a level scoop of powder by using the handle of the second scoop to scrape off the extra powder.
Danish: Udmål en strøgen skefuld pulver ved at anvende håndtaget af den anden ske til at skrabe
English: Based on in vitro data, nelfinavir is unlikely to inhibit other cytochrome P450 isoforms at concentrations in the therapeutic range.
Danish: Baseret på in vitro data er det usandsynligt, af nelfinavir hæmmer andre cytokrom P450 isoformer ved koncentrationer inden for det
English: Coadministration of midazolam with nelfinavir may cause a large increase in the concentration of this benzodiazepine.
Danish: Samtidig administration af midazolam og nelfinavir kan forårsage en stor stigning i koncentrationen af dette benzodiazepin.
English: • Store in the original container.
Danish: • Opbevares i original emballage.
English: Plasma levels of certain HIV-1 protease inhibitors, which are metabolised predominantly by CYP3A4, can be increased by the co-administration of low-dose ritonavir, which is an inhibitor of this metabolism.
Danish: Plasmakoncentrationerne af visse hiv-1-proteasehæmmere, som overvejende metaboliseres af CYP3A4, kan øges ved samtidig administration af lavdosis ritonavir, som hæmmer denne metabolisering.
English: Do not take Viracept and tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Tag ikke Viracept, og fortæl din læge eller på apoteket, hvis du tager nogle af de nedenstående
English: If you have haemophilia type A or B, in rare cases your bleeding may increase.
Danish: Hvis du har hæmofili type A eller B, kan din blødning i
English: VIRACEPT is indicated in antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older.
Danish: VIRACEPT er indiceret til antiretroviral kombinationsbehandling af voksne, unge og børn over 3 år, der er smittet med human immundefekt virus (hiv-1).
English: For children aged 3 to 13 years, the recommended dose of Viracept tablets is based on their body weight.
Danish: Til børn i alderen 3 til 13 år beregnes den anbefalede dosis af Viracept-tabletter ud fra deres kropsvægt.
English: There are two scoops provided in the box, a white 1 gram scoop and a blue 5 gram scoop.
Danish: Pakningen indeholder to skeer, en hvid 1 grams-ske og en blå 5 grams-ske.
English: The clinical relevance of these findings has not been established.
Danish: Den kliniske betydning af dette fund er ikke fastslået.
English: For children aged 3 to 13 years, the recommended dose of Viracept powder is based on their body weight.
Danish: Til børn i alderen 3 til 13 år beregnes den anbefalede dosis af Viracept-pulver ud fra deres kropsvægt.
English: N: number of subjects with evaluable pharmacokinetic results Ctrough values are not presented in the table because they are not available from all studies
Danish: Protokolspecifik dosis (det aktuelle dosisinterval) 2 N: Antal forsøgspersoner med farmakokinetiske resultater, som kunne vurderes Ctrough-værdier er ikke præsenteret i tabellen, idet de ikke er tilgængelige fra alle studier
English: Also contains sweetener aspartame (E951), sucrose palmitate, potassium, natural and artificial flavourings and other constituents.
Danish: Pulveret indeholder også sødestoffet aspartam (E951), saccharosepalmitat, kalium, naturlige og kunstige smagsstoffer og andre indholdsstoffer.
English: Combination of simvastatin or lovastatin and nelfinavir is contraindicated (see contraindication).
Danish: Kombinationen af simvastatin eller lovastatin og nelfinavir er kontraindiceret (se Kontraindikationer) .
English: Co-administration of a PI with sildenafil is expected to substantially increase sildenafil concentration and may result in an increase in sildenafil associated adverse events, including hypotension, visual changes, and priapism.
Danish: Samtidig administration af en proteasehæmmer med sildenafil forventes at øge sildenafilkoncentrationen i betydelig grad og kan resultere i en øgning af sildenafilrelaterede bivirkninger, inklusive hypotension, synsforstyrrelser og priapisme.
English: Roche S.p.A.
Danish: Roche S.A.
English: Concomitant use of protease inhibitors with lovastatin or simvastatin is contraindicated.
Danish: Samtidig anvendelse af proteasehæmmere og lovastatin eller simvastatin er kontraindiceret.
English: VIRACEPT film-coated tablets are provided in HDPE plastic bottles containing either 270 or 300 tablets, fitted with HDPE child resistant closures with polyethylene liners.
Danish: VIRACEPT filmovertrukne tabletter leveres i HDPE plastikbeholdere, indeholdende enten 270 eller 300 tabletter, forsynet med børnesikrede polypropylenlåg med et polyethylenindlæg.
English: Not applicable.
Danish: Ikke undersøgt.
English: If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Viracept.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, så tal med din læge eller apoteket, før du tager Viracept.
English: Saquinavir concentrations not measured
Danish: Saquinavirkoncentrationer er ikke målt
English: Do not take Viracept and tell your doctor or pharmacist if any of these apply to you.
Danish: Tag ikke Viracept og fortæl din læge eller på apoteket, hvis noget af ovenstående gælder for dig.
English: • The other ingredients are calcium silicate, crospovidone, magnesium stearate, indigo carmine
Danish: • De øvrige indholdsstoffer er calciumsilicat, crospovidon, magnesiumstearat, indigotin (E132)
English: • Amiodarone or quinidine (for an uneven heart beat)
Danish: • Amiodaron eller quinidin (mod abnorm hjerterytme)
English: The metabolism of pravastatinand fluvastatinis not dependent on CYP3A4, and interactions are not expected with nelfinavir.
Danish: Pravastatin og fluvastatins metabolisme er ikke afhængig af CYP3A4, og interaktioner forventes ikke med nelfinavir.
English: Co- administration with rifampicin is contra-indicated due to a reduction in exposure to nelfinavir.
Danish: Samtidig administration med rifampicin er kontraindiceret på grund af formindsket eksponering for nelfinavir.
English: Saquinavir AUC ↑ 392% Nelfinavir concentrations not measured
Danish: Saquinavir AUC ↑ 392 % Nelfinavirkoncentrationer er ikke målt
English: Efavirenz AUC ↔
Danish: Nelfinavir AUC ↔
English: Pharmacotherapeutic group:direct acting antivirals, ATC code: J05AE04.
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale lægemidler, ATC kode: J05 A E04.
English: 5 g 6 g 7 g 8 g 10 g 11 g
Danish: 5 g 6 g 7 g 8 g 10 g 11 g 13 g 15 g
English: Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor'.
Danish: Viracept indeholder det aktive indholdsstof nelfinavir, som er en proteasehæmmer.
English: Consider alternatives that are not substrates of CYP3A4 such as pravastatin or fluvastatin.
Danish: Overvej alternativer, der ikke er substrater for CYP3A4, såsom pravastatin og fluvastatin.
English: Co-administration of VIRACEPT with these medicinal products is expected to increase their concentrations and may result in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see section 4.5).
Danish: Samtidig administration af VIRACEPT og disse lægemidler forventes at øge deres plasmakoncentration, hvilket kan resultere i relaterede bivirkninger såsom hypotension, synkope, synsforstyrrelser og forlænget erektion (se pkt.
English: Also contains E95, sucrose palmitate, potassium.
Danish: Indeholder også E951, saccharosepalmitat, kalium.
English: The recommended dose of VIRACEPT 50 mg/g oral powder is 1250 mg twice a day (BID) or 750 mg three times a day (TID), for patients unable to take tablets.
Danish: Den anbefalede dosis af VIRACEPT 50 mg/g oralt pulver er 1250 mg to gange daglig (BID) eller 750 mg tre gange daglig (TID) til patienter, som ikke kan tage tabletter.
English: • Medicines made from ergot such as cabergoline, ergotamine or lisuride (for Parkinson's disease or migraine)
Danish: • Lægemidler lavet ud fra sekale som f.eks. cabergolin, ergotamin eller lisurid (mod Parkinsons
English: Consider alternatives that are not metabolised by CYP3A4 such as beclomethasone.
Danish: Overvej alternativer, der ikke metaboliseres af CYP3A4, såsom beclomethason.
English: A 49 %-69 % increase was observed in AUC of nelfinavir in the hepatically impaired groups with impairment (Child-Turcotte Classes A to C) compared to the healthy group.
Danish: Der blev set en stigning på 49 % - 69 % af nelfinavirs AUC i den leverpåvirkede gruppe med påvirkning (Child-Turcotte klasse A til C) sammenlignet med den raske gruppe.
English: These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump').
Danish: Disse ændringer kan inkludere tab af fedt fra ben, arme og ansigt, øget fedt på maven og omkring indre organer, brystforstørrelse og fedtpukkel i nakken (bøffelnakke).
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: MARKEDSFØRINGSTILLADELSENUMMER