natgillin/translations-raw huggingface dataset:
Studie APV3002 er en randomiseret, åben undersøgelse med 649 antiretroviral- behandlingsnaive patienter med fremskreden hiv- sygdom, hvor fosamprenavir/ ritonavir (1400 mg/ 200 mg en gang daglig n=322) blev sammenlignet med nelfinavir (1250 mg to gange daglig, n=327), i begge tilfælde kombineret med lamivudin (150 mg to gange daglig) og abacavir (300 mg to gange daglig).
Study APV30002 is a randomised, open-label trial of 649 antiretroviral treatment naïve patients with advanced HIV-disease, investigating fosamprenavir/ritonavir (1400 mg/200 mg QD n=322) compared to nelfinavir (1250 mg BID n=327), each in combination with lamivudine (150 mg twice daily) and abacavir (300 mg twice daily).
Den mediane baseline hiv- 1 RNA var 4, 8 log10 kopier/ ml i begge behandlingsgrupper.
Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment groups.
Det mediane baseline CD4+ celletal var henholdsvis 177 og 166 x106 celler/ l i nelfinavir - og fosamprenavir/ ritonavirgrupperne.
Median baseline CD4+ cell counts were 177 and 166 x106 cells/l for the nelfinavir and fosamprenavir/ritonavir groups respectively.
Efter 48 uger vistes non- inferiority, idet 68% af patienterne i nelfinavirgruppen og 69% af patienterne behandlet med fosamprenavir/ ritonavir havde < 400 kopier/ ml plasma hiv- 1 RNA, mens 53% af nelfinavir - og 55% af fosamprenavir/ ritonavirpatienterne havde < 50 copies/ ml hiv- 1 RNA (intent- to- treat, rebound/ seponering = svigt).
At week 48, non-inferiority was shown with 68% of patients in the group treated with nelfinavir and 69% patients treated with fosamprenavir/ritonavir having plasma HIV-1 RNA < 400 copies/ml whereas 53% in the nelfinavir and 55% in the fosamprenavir/ritonavir patients had HIV-1 RNA < 50 copies/ml (intent-to-treat, rebound/discontinuation = failure).
Den mediane stigning fra baseline i CD4+ celletallet efter 48 uger var 207 celler/ mm3 og 203 celler/ mm3 for henholdsvis nelfinavir - og fosamprenavir/ ritonavirgrupperne.
The median increase from baseline in CD4+ cell count over 48 weeks was 207 cells/mm3 and 203 cells/mm3 in the nelfinavir and fosamprenavir/ritonavir groups respectively.
Virologisk svigt var større i nelfinavir gruppen (17%) end i fosamprenavir/ ritonavirgruppen (7%).
The virological failure was greater in the nelfinavir group (17%) than in the fosamprenavir/ritonavir group (7%).
Behandlingsfremkaldt NRTI resistens var signifikant mindre hyppigt med fosamprenavir/ ritonavir sammenlignet med nelfinavir (13% mod 57%; p < 0, 001).
Treatment emergent NRTI resistance was significantly less frequent with fosamprenavir/ritonavir compared to nelfinavir (13% versus 57%; p < 0.001).
Nelfinavirs farmakokinetiske egenskaber er blevet evalueret hos raske frivillige og hos hiv- smittede patienter.
The pharmacokinetic properties of nelfinavir have been evaluated in healthy volunteers and HIV-infected patients.
Der blev ikke observeret nogen væsentlige forskelle mellem raske frivillige og hiv- smittede patienter.
No substantial differences have been observed between healthy volunteers and HIV-infected patients.
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 timer.
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.
Efter multipel dosering med 750 mg hver 8. time i 28 dage (steady- state), var gennemsnittet for peak- plasmakoncentrationer (Cmax) 3- 4 µg/ ml og plasmakoncentrationerne inden næste dosis (trough) var 1- 3 µg/ ml.
After multiple dosing with 750 mg every 8 hours for 28 days (steady-state), peak plasma concentrations (Cmax) averaged 3-4 µg/ml and plasma concentrations prior to the next dose (trough) were 1-3 µg/ml.
Dette blev imidlertid ikke observeret efter multipel dosering.
A greater than dose-proportional increase in nelfinavir plasma concentrations was observed after single doses; however, this was not observed after multiple dosing.
Et farmakokinetisk studie hos hiv- positive patienter sammenlignede 1250 mg to gange daglig med 750 mg tre gange daglig, begge i 28 dage.
A pharmacokinetic study in HIV-positive patients compared multiple doses of 1250 mg twice daily (BID) with multiple doses of 750 mg three times daily (TID) for 28 days.
2, 2 ± 1, 3 μg/ ml og 0, 7 ± 0, 4 μg/ ml.
Patients receiving VIR ACEPT BID (n=10) achieved nelfinavir Cmax of 4.0 ± 0.8 µg/ml and morning and evening trough concentrations of 2.2 ± 1.3 µg/ml and 0.7 ± 0.4 µg/ml, respectively.
1, 4 ± 0, 6 μg/ ml og 1, 0 ± 0, 5 μg/ ml.
Patients receiving VIRACEPT TID (n=11) achieved nelfinavir peak plasma concentrations (Cmax) of 3.0 ± 1.6 µg/ml and morning and evening trough concentrations of 1.4 ± 0.6 µg/ml and 1.0 ± 0.5 µg/ml, respectively.
Forskellen mellem trough- koncentrationerne om morgenen og om eftermiddagen eller aftenen efter behandling to eller tre gange daglig blev også observeret hos raske frivillige, hos hvem dosisintervallerne var præcis 8 eller 12 timer.
The difference between morning and afternoon or evening trough concentrations for the TID and BID regimens was also observed in healthy volunteers who were dosed at precise 8- or 12-hour intervals.
Nelfinavirs farmakokinetik er den samme for BID og TID administration.
The pharmacokinetics of nelfinavir are similar during BID and TID administration.
Hos patienter var nelfinavir AUC0- 24 52, 8 ± 15, 7 μg⋅time/ ml (n=10) ved administration af 1250 mg to gange daglig og 43, 6 ± 17, 8 μg⋅time/ ml (n=11) ved administration af 750 mg tre gange daglig.
In patients, the nelfinavir AUC0-24 with 1250 mg BID administration was 52.8 ± 15.7 µg⋅h/ml (n=10) and with 750 mg TID administration was 43.6 ± 17.8 µg⋅h/ml (n=11).
For begge grupper er trough- koncentrationerne i hele dosisintervallet mindst tyve gange højere end middel- IC95.
Trough drug exposures remain at least twenty fold greater than the mean IC95 throughout the dosing interval for both regimens.
Efter enkeltdoser observeredes en større stigning i nelfinavir- plasmakoncentrationen end svarende til dosis- proportionaliteten; dette blev dog ikke set efter multipel dosering.
A greater than dose-proportional increase in nelfinavir plasma concentrations was observed after single doses; however, this was not observed after multiple dosing.
Maksimale plasmakoncentrationer og plasma AUC var konstant 2 til 3 gange højere efter fødeindtagelse sammenlignet med fastende tilstand.
Effect of food on gastrointestinal absorption: maximum plasma concentrations and area under the plasma concentration-time curve were consistently 2 to 3-fold higher under fed conditions compared to fasting.
De øgede plasmakoncentrationer i forbindelse med føde var uafhængige af måltidernes fedtindhold.
The increased plasma concentrations with food were independent of fat content of the meals.
Effekten af måltidets fedtindhold på tilgængeligheden af nelfinavir blev undersøgt i et studie, hvor der blev anvendt 250 mg filmovertrukne tabletter.
The effect of meal content on nelfinavir exposure was investigated in a study using the 250 mg film-coated tablets formulation.
Steady state nelfinavir AUC og Cmax var henholdsvis 15% og 20% højere, når dosis blev indtaget efter et måltid bestående af 800 kcal/ 50% fedt, i forhold til indtagelse af dosis efter et let måltid (350 kcal/ 33% fedt), hvilket antyder at måltidets fedtindhold har mindre betydning for tilgængeligheden af nelfinavir ved multipel dosering end det ville antages på baggrund af data fra enkeltdosisstudier.
Steady state nelfinavir AUC and Cmax were respectively 15% and 20% higher when doses followed a 800 kcal/50% fat meal compared to those following a light meal
Hos både dyr og mennesker oversteg det beregnede fordelingsvolumen (2- 7 l/ kg) legemets vandfase hvilket tyder på stor penetration af nelfinavir ind i væv.
Distribution: in both animals and humans, the estimated volumes of distribution (2-7 l/kg) exceeded total body water, suggesting extensive penetration of nelfinavir into tissues.
Skønt der ikke er udført undersøgelser på mennesker viste undersøgelser med en enkelt 50 mg/ kg dosis 14C - nelfinavir på rotter, at koncentrationerne i hjernen var mindre end i andre væv, men oversteg in vitro EC95 for antiviral aktivitet.
Although no studies have been conducted in humans, studies with a single 50 mg/kg dose of 14C-nelfinavir in rats showed that concentrations in the brain were lower than in other tissues, but exceeded the in vitro EC95 for antiviral activity.
Nelfinavir i serum er kraftigt proteinbundet (≥ 98%).
Nelfinavir in serum is extensively protein-bound (≥ 98%).
Uomdannet nelfinavir fandtes at være på 82- 86% af den totale plasma- radioaktivitet efter en enkel oral 750 mg dosis 14C- nelfinavir.
Metabolism: unchanged nelfinavir comprised 82-86% of the total plasma radioactivity after a single oral 750 mg dose of 14C-nelfinavir.
In vitro er de forskellige isoformer af cytochrome P- 450, inklusive CYP3A, CYP2C19/ C9 og CYP2D6 ansvarlige for metaboliseringen af nelfinavir.
In vitro, multiple cytochrome P-450 isoforms including CYP3A, CYP2C19/C9 and CYP2D6 are responsible for metabolism of nelfinavir.
I plasma fandtes én hovedmetabolit og flere andre oxidative metabolitter.
One major and several minor oxidative metabolites were found in plasma.
15 Hovedmetabolitten M8 (tert- butyl hydroxynelfinavir) har in vitro antiviral aktivitet, som er lig moderstoffet, og dets dannelse er katalyseret af det polymorfe cytochrom CYP2C19.
The major oxidative metabolite, M8 (tert-butyl hydroxy nelfinavir), has in vitro antiviral activity equal to the parent drug and its formation is catalysed by the polymorphic cytochrome CYP2C19.
25% af den totale nelfinavirrelaterede plamakoncentration.
In subjects with normal CYP2C19 activity, plasma levels of this metabolite are approximately 25% of the total plasma nelfinavir-related concentration.
4. 5) forventes det, at plasmakoncentrationen af nelfinavir øges, mens koncentrationen af tert- butyl hydroxynelfinavir vil være ubetydelig eller ikke- målelig.
It is expected that in CYP2C19 poor metabolisers or in patients receiving concomitantly strong CYP2C19 inhibitors (see section 4.5), nelfinavir plasma levels would be elevated whereas levels of tert-butyl hydroxy nelfinavir would be negligible or non-measurable.
Begrænsede kliniske data viser, at patienter med ubetydelig eller ikke- målelig plasmakoncentration af metabolitten ikke udviste et nedsat virologisk respons eller en anderledes sikkerhedsprofil end populationen i hele studiet.
Limited clinical data suggest that patients with very low or non-measurable plasma concentrations of the metabolite and elevated concentrations of nelfinavir do not show a reduced virological response or a different safety profile when compared with the whole study population.
Clearance efter enkelt oral indgift (24- 33 l/ t) og gentagen indgift (26- 61 l/ t) indicerer, at nelfinavir udviser medium til høj hepatisk biotilgængelighed.
Elimination: oral clearance estimates after single doses (24-33 l/h) and multiple doses (26-61 l/h) indicate that nelfinavir exhibits medium to high hepatic bioavailability.
Terminalhalveringstiden i plasma var typisk 3, 5 til 5 timer.
The terminal half-life in plasma was typically 3.5 to 5 hours.
Størstedelen (87%) af en oral 750 mg dosis indeholdende 14C- nelfinavir blev genfundet i fæces; total fækal radioaktivitet bestod af nelfinavir (22%) og en række oxidative metabolitter (78%).
The majority (87%) of an oral 750 mg dose containing 14 C-nelfinavir was recovered in the faeces; total faecal radioactivity consisted of nelfinavir (22%) and numerous oxidative metabolites (78%).
Kun 1- 2% af dosis blev genfundet i urinen og hovedsagelig som uomdannet nelfinavir.
Only 1-2% of the dose was recovered in urine, of which unchanged nelfinavir was the major component.
Farmakokinetik i specielle kliniske situationer:
Pharmacokinetics in special clinical situations:
2 til 3 gange højere end hos voksne med stor variabilitet mellem individer.
Pharmacokinetics in children and the elderly: in children between the ages of 2 and 13 years, the clearance of orally administered nelfinavir is approximately 2 to 3 times higher than in adults, with large intersubject variability.
25- 30 mg/ kg tre gange dagligt opnås steady- state plasmakoncentrationer svarende til de der opnås hos voksne patienter som fik 750 mg tre gange dagligt.
Administration of VIRACEPT oral powder or tablets with food at a dose of approximately 25-30 mg/kg TID achieves steady-state plasma concentrations similar to adult patients receiving 750 mg TID.
I en åben, prospektiv undersøgelse undersøgtes farmakokinetikken af VIRACEPT BID og TID regimer hos 18 hiv- smittede børn i alderen 2- 14 år.
In an open prospective study, the pharmacokinetics of BID and TID VIRACEPT regimens in 18 HIV infected children aged 2-14 years were investigated.
Børn der vejede under 25 mg/ kg fik 30- 37 mg/ kg nelfinavir TID eller 45- 55 mg/ kg nelfinavir BID.
Children weighing less than 25 kg received 30-37 mg/kg nelfinavir TID or 45-55 mg/kg nelfinavir BID.
Børn over 25 kg fik 750 mg TID eller 1250 mg BID.
Children over 25 kg received 750 mg TID or 1250 mg BID.
Cmin, Cmax, og AUC0- 24 var alle signifikant højere på BID- regimet sammenlignet med TID- regimet.
The Cmin, Cmax and AUC0-24 were all significantly higher with the BID regimen compared with the TID regimen.
Desuden nåede 14 af 18 (78%) og 11 af 18 (61%) på BID regimet Cmin- værdier på 1- 3 μg/ ml og Cmax - værdier på 3- 4 μg/ ml, hvorimod kun 4 af 18 (22%) og 7 af 18 (39%) nåede disse værdier på TID regimet.
In addition, in twice daily application, 14 out of 18 (78%) and 11 out of 18 (61%) reached Cmin values of 1-3 µg/ml and Cmax values of 3-4 µg/ml, whereas in TID application only 4 out of 18 (22%) and 7 out of 18 (39%) reached these values.
Farmakokinetik hos patienter med leverinsufficiens:
Pharmacokinetics in patients with liver impairment:
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.
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.
I in vitro studier blev klonede humane kalium kanaler fra hjertevæv (hERG) hæmmet ved høje koncentrationer af nelfinavir og dets aktive metabolit M8. hERG kalium kanalerne 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.
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.
Data fra produkter, der forlænger QT intervallet indikerer dog, at en blokering af hERG kalium kanaler med mere end 20% kan være klinisk relevant.
However, based on data from products known to prolong the QT-interval, a block of hERG potassium channels of > 20% may be clinically relevant.
4. 9)
Therefore the potential for QT prolongation should be considered in cases of overdose (see section 4.9).
Akutte og kroniske toksikologiske undersøgelser med oral indgift blev udført på mus (500 mg/ kg/ dag), rotte (op til 1. 000 mg/ kg/ dag) og abe (op til 800 mg/ kg/ dag).
Acute and chronic toxicity: oral acute and chronic toxicity studies were conducted in the mouse (500 mg/kg/day), rat (up to 1,000 mg/kg/day) and monkey (up to 800 mg/kg/day).
Hos aber blev der
There were increased liver weights and dose-related thyroid follicular cell hypertrophy in rats.
16 observeret vægttab og generel fysisk svækkelse sammen med generelle tegn på gastrointestinal toksicitet.
Weight loss and general physical decline was observed in monkeys together with general evidence of gastrointestinal toxicity.
In vitro og in vivo undersøgelser med og uden metabolisk aktivering har vist at nelfinavir ikke har nogen mutagen eller genotoksisk aktivitet.
Mutagenicity: in vitro and in vivo studies with and without metabolic activation have shown that nelfinavir has no mutagenic or genotoxic activity.
Carcinogenicitet:
Carcinogenicity:
To års carcinogenicitetsstudier med nelfinavir mesilat blev udført på rotter og mus.
Two year oral carcinogenicity studies with nelfinavir mesilate were conducted in mice and rats.
Hos mus viste administration af op til 1000 mg/ kg/ dag ikke tegn på nogen onkogen effekt.
In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an oncogenic effect.
Hos rotter gav oral administration af 1000 mg/ kg/ dag igennem to år en forhøjet hyppighed af follikulære celleadenomer og carcinomer i thyreoidea i forhold til kontrolgruppen.
In rats administration of 1000 mg/kg/day resulted in increased incidences of thyroid follicular cell adenoma and carcinoma, relative to those for controls.
Den systemiske belastning var 3- 4 gange højere end hos mennesker, som fik terapeutiske doser.
Systemic exposures were 3 to 4 times those for humans given therapeutic doses.
Administration af 300 mg/ kg/ dag medførte øget hyppighed af follikulære celleadenomer i thyreoidea.
Administration of 300 mg/kg/day resulted in an increased incidence of thyroid follicular cell adenoma.
Det er vist at kronisk behandling af rotter med nelfinavir fremkalder effekter, som er konsistente med enzyminduktion, som prædisponerer rotter, men ikke mennesker for thyreoidea- neoplasmer.
Chronic nelfinavir treatment of rats has been demonstrated to produce effects consistent with enzyme induction, which predisposed rats, but not humans, to thyroid neoplasms.
- mikrokrystalinsk cellulose
- microcrystalline cellulose
- dikaliumphosphat
- dibasic potassium phosphate
- crospovidon
- crospovidone
- hydroxylpropyl- methylcellulose
- hydroxypropyl methylcellulose
- saccharosepalmitat
- sucrose palmitate
- naturligt og kunstigt smagsstof.
- natural and artificial flavour
4. 2).
This medicinal product must not be mixed with acidic substances due to taste (see section 4.2).
6. 5 Emballagetype og pakningsstørrelser
17 6.5 Nature and contents of container
VIRACEPT 50 mg/ g oralt pulver leveres i HDPE plastikflasker forsynet med børnesikrede polypropylenlåg med et polyethylenindlæg.
VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
17 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
Pakningen indeholder to skeer, en hvid 1 grams- ske og en blå 5 grams- ske.
There are two scoops provided in the box, a white 1 gram scoop and a blue 5 gram scoop.
2, anvendes inden 6 timer
2. mix powder with water, milk, formula, soy milk, dietary supplements or pudding 3. do not mix powder with acidic food or juice 4. powder mixed in the media as described under 2 is recommended to be used within 6 hours
22. januar 1998 Dato for seneste genregistrering:
22 January 1998 Date of latest renewal:
Hver filmovertruken tablet indeholder nelfinavir mesilat svarende til 250 mg nelfinavir.
Each film-coated tablet contains nelfinavir mesilate corresponding to 250 mg of nelfinavir.
5. 1.
See section 5.1.
Behandling med VIRACEPT skal påbegyndes af en læge med erfaring i behandling af hiv infektion.
Therapy with VIRACEPT should be initiated by a physician experienced in the management of HIV infection.
5. 2).
VIRACEPT is administered orally and should always be ingested with food (see section 5.2).
1250 mg (fem tabletter á 250 mg) to gange daglig (BID) eller 750 mg (tre 250 mg tabletter) tre gange dagligt (TID).
Patients older than 13 years: the recommended dosage of VIRACEPT film-coated tablets is 1250 mg (five 250 mg tablets) twice a day (BID) or 750 mg (three 250 mg tablets) three times a day (TID) by mouth.
5. 1).
The efficacy of the BID (twice daily) regimen has been evaluated versus the TID (three times daily) regimen primarily in patients naïve to PIs (see section 5.1).
Den anbefalede initiale dosis til børn er 50- 55 mg/ kg to gange daglig eller 25- 30 mg/ kg legemsvægt indgivet tre gange dagligt.
Patients aged 3 to 13 years: for children, the recommended starting dose is 50-55 mg/kg BID or, if using a TID regimen, 25 – 30 mg/kg body weight per dose.
Til børn, som ikke kan indtage tabletter, kan der gives VIRACEPT oralt pulver (se produktresumé for VIRACEPT oralt pulver).
For children unable to take tablets, VIRACEPT oral powder may be administered (see Summary of Product Characteristics for VIRACEPT oral powder).
Den anbefalede dosis af VIRACEPT filmovertrukne tabletter til indgivelse to gange daglig til børn mellem 3 og 13 år er som følger:
The recommended dose of VIRACEPT film-coated tablets to be administered BID to children aged 3 to 13 years is as follows:
Legemsvægt
Weight kg
filmovertrukne tabletter per dosis *
Number of VIRACEPT 250 mg film-coated tablets per dose*
til < 22 ≥ 22
to < 22 ≥ 22
19 Den anbefalede dosis af VIRACEPT filmovertrukne tabletter til indgivelse tre gange daglig til børn mellem 3 og 13 år er som følger:
19 The recommended dose of VIRACEPT film-coated tablets to be administered TID to children aged 3 to 13 years is as follows:
til < 22 ≥ 22
to < 23 ≥ 23
* Se Produktresumé for VIRACEPT oralt pulver til patienter som vejer mindre end 18 kg.
*see Summary of Product Characteristics for VIRACEPT oral powder for patients with less than 18 kg body weight.
4. 5].
Co-administration with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 [e.g., terfenadine, astemizole, cisapride, amiodarone, quinidine, pimozide, triazolam, orally administered midazolam (for caution on parenterally administered midazolam, see section 4.5), ergot derivatives; see section 4.5].
4. 5).
John’s wort (Hypericum perforatum) must not be used while taking nelfinavir due to the risk of decreased plasma concentrations and reduced clinical effects of nelfinavir (see section 4.5).
Patienterne skal instrueres om; at VIRACEPT ikke helbreder en hiv- infektion, at de fortsat kan få infektioner eller andre sygdomme, som er releteret til hiv- sygdommen samt at det ikke er vist, at VIRACEPT nedsætter risikoen for overførsel af hiv- sygdommen ved seksuel kontakt eller smittet blod.
Patients should be instructed that VIRACEPT is not a cure for HIV infection, that they may continue to develop infections or other illnesses associated with HIV disease, and that VIRACEPT has not been shown to reduce the risk of transmission of HIV disease through sexual contact or blood contamination.
Immun reaktiveringssyndrom:
Immune Reactivation Syndrome:
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/ eller fokale mycobakterielle infektioner og Pneumocystis carinii pneumoni.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Sikkerheden og effekten af nelfinavir er ikke efterprøvet hos patienter med betydelig tilgrundliggende leversygdom.
The safety and efficacy of nelfinavir has not been established in patients with significant underlying liver disorders.
20 Patienter med allerede kendt leverdysfunktion, inklusive kronisk aktiv hepatitis har en øget frekvens af leverfunktionsabnormaliteter ved antiretroviral kombinationsterapi og bør monitoreres i henhold til standard praksis.
20 monitored according to standard practice.
Der bør i mangel på sådanne studier, udvises forsigtighed, idet stigninger i nelfinavir niveauer og/ eller stigninger i lever- enzymer kan forekomme.
In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may occur.