natgillin/translations-raw huggingface dataset:
Post-marketing experience with nelfinavir
Postmarketinške izkušnje z nelfinavirjem
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh po doseženem pomembnem mejniku (pri farmakovigilanci ali zmanjševanju tveganja),
Safety of combination not established; combination not recommended
Varnosti kombinacije niso ugotovili, zato jemanja te kombinacije ne priporočamo.
PSUR: The Marketing Authorisation Holder will submit yearly PSURs.
PSUR: Imetnik dovoljenja za promet z zdravilom bo PSURe predložil letno.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Natisnjeno navodilo za uporabo zdravila mora vsebovati ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
It helps to reduce the number of HIV
Pomaga zmanjšati število delcev
The pharmacokinetic data from Study AG1343-556 were more variable than data from other studies conducted in the paediatric population; the 95% confidence interval for AUC24 was 9 to 121 mg.hr/L.
Farmakokinetični podatki iz študije AG1343-556 so bili bolj raznoliki kot podatki iz drugih študij, ki so bile narejene na pediatrični populaciji; 95 % interval zaupanja za AUC24 je bil od 9 do 121 mg.h/l.
Systemic exposures were 3 to 4 times those for humans given therapeutic doses.
Sistemska izpostavljenost je bila 3- do 4-krat večja kot pri terapevtskih odmerkih pri ljudeh.
LOCF= Last observation carried forward ITT = Intention to Treat NC = F: non-completers = failures
LOCF (last observation carried forward) = zadnje opazovanje, prenešeno naprej ITT (intention to treat) = vključeni v zdravljenje NC = F (non-completers= failures): nedokončano zdravljenje = neuspeh
• Do not use after the expiry date stated on the label and carton.
• Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
• Rifampicin (for tuberculosis (TB))
• rifampicin (za tuberkulozo (TB)),
Each dose contains up to 5.9 milligrams of sucrose, which should be taken into account in patients with diabetes mellitus.
En odmerek vsebuje do 5,9 miligramov saharoze, kar je treba upoštevati pri bolnikih s sladkorno boleznijo.
VIRACEPT oral powder should not be reconstituted with water in its original container.
Peroralnega praška VIRACEPT se ne sme rekonstituirati z vodo v originalnem vsebniku.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Pri sočasnem protivirusnem zdravljenju hepatitisa B ali C, prosimo, glejte tudi ustrezna navodila za uporabo teh zdravil.
• However if it is nearly time for your next dose, skip the missed dose.
• Če je skoraj čas za naslednji odmerek, izpuščenega odmerka ne vzemite.
Sildenafil at a starting dose not exceeding 25 mg in 48 hours.
Začetni odmerek sildenafila ne sme preseči 25 mg v 48 urah.
Nelfinavir is principally metabolised and eliminated by the liver.
Nelfinavir se v glavnem presnavlja in izloča skozi jetra.
Adverse reactions in clinical studies are summarised in Table 2.
Neželeni učinki iz kliničnih študij so povzeti v preglednici 2.
• You have high blood sugar (diabetes).
• imate visok krvni sladkor (sladkorno bolezen),
Small, non-statistically significant differences were observed in other pharmacokinetic parameters with no trend favouring one regimen over the other.
Majhne, statistično nepomembne razlike so opazili pri drugih farmakokinetičnih parametrih, nobena od razlik pa ne predstavlja prednosti enega ali drugega režima odmerjanja.
Once mixed, the entire contents must be consumed in order to obtain the full dose.
Po mešanju je treba zaužiti celotno količino, da se prejme celotni odmerek.
On rare occasions these muscle problems have been serious causing muscle degeneration
Redko so bile te mišične težave resne in so povzročile razgradnjo
During these trials less than 13% of patients in total discontinued treatment due to adverse events.
Zaradi neželenih dogodkov je zdravljenje med potekom teh kliničnih preskušanj prekinilo manj kot 13 % bolnikov.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Bolniki s hemofilijo se morajo zavedati možnosti povečane krvavitve.
AUC24 (mg.hr/L) Arithmetic mean ± SD
AUC24 (mg.h/l) aritmetična sredina ± SD
The VIRACEPT suspension should be taken with a meal.
VIRACEPT suspenzijo je treba jemati ob obroku.
• Do not breast-feed while taking Viracept because HIV may be passed to the baby.
• Med jemanjem zdravila Viracept ne smete dojiti, ker virus HIV lahko preide na otroka.
The safety of the VIRACEPT 250 mg tablet was studied in controlled clinical trials with over 1300 patients.
Varnost zdravila VIRACEPT 250 mg tablete so proučevali v kontroliranih kliničnih preskušanjih pri več kot 1300 bolnikih.
Also some other medicines can affect the way Viracept works.
Tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Viracept.
Oral use Read the package leaflet before use
Za peroralno uporabo Pred uporabo preberite priloženo navodilo
Children aged 3 to 13 years
Otroci, od 3 do 13 let
Sensitive
Občutljive
The overall incidence of other mutations associated with primary PI resistance was 9.6 % for the L90M substitution where as substitutions at 48, 82 and 84 were not observed.
Skupna incidenca drugih mutacij, povezanih s primarno odpornostjo na zaviralce proteaz, je bila 9,6 % za L90M zamenjavo, zamenjav na mestih 48, 82 in 84 pa niso opazili.
How much to give each time (in grams)
odmerek, ki ga je treba vsakič dati (v gramih)
VIRACEPT has no or negligible influence on the ability to drive and use machines.
Zdravilo VIRACEPT nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
See section 2 and 6.1 for further information on excipients.
Za dodatne informacije o pomožnih snoveh glejte tudi poglavje 2 in 6.1.
• Blue 5 gram (5g) scoop.
• Modra merica po 5 gramov (5 g).
Viracept powder is for people who cannot take tablets.
Zdravilo Viracept v obliki praška je za osebe, ki ne morejo zaužiti tablet.
Rosuvastatin may also be administered with nelfinavir but patients should be monitored.
Rosuvastatin se lahko daje z nelfinavirjem toda bolnike je potrebno spremljati.
Studies in lactating rats showed that nelfinavir is excreted in breast milk.
Študije pri podganah v laktaciji so pokazale, da se nelfinavir izloča v mleko.
In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Hiperglikemija je bila pri nekaterih bolnikih huda, v posameznih primerih tudi povezana s ketoacidozo.
• You have kidney problems.
• imate težave z ledvicami,
This is because Viracept can affect the way some other medicines work.
To pa zato, ker zdravilo Viracept lahko vpliva na delovanje nekaterih zdravil.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1, dated 30 July 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil raziskave in dodatne farmakovigilančne aktivnosti, opisane v načrtu farmakovigilance, sprejetem v različici 1 z dne 30. julij 2007 načrta za obvladovanje tveganja v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
OTHER SPECIAL WARNING(S), IF NECESSARY Do not reconstitute in the bottle
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zdravila ne pripravljajte v steklenici
Carefully monitor the increase in weight of your child to ensure the appropriate total daily dose is taken.
Pozorno spremljajte povečanje telesne mase vašega otroka, da zagotovite jemanje ustreznega celokupnega dnevnega odmerka.
Antidepressants Trazodone
Antidepresivi trazodon
The signs include severe pains in your stomach that spread to your back.
• pankreatitis: znaki vključujejo hude bolečine v želodcu, ki se širijo v hrbet,
Take all your doses at the right time each day.
Odmerke jemljite vsak dan ob pravem času.
Very common (affect more than 1 in 10 people): • Diarrhoea.
Zelo pogosti (pojavijo se pri več kot 1 od 10 ljudi): • driska.
The pharmacokinetics of nelfinavir have been investigated in 5 studies in paediatric patients from birth to 13 years of age.
Farmakokinetiko nelfinavirja so proučevali v 5 študijah s pediatričnimi bolniki, od rojstva do 13 let starosti.
ITT (NC = F) Observed data LOCF
ITT (NC = F) Opaženi podatki LOCF
• There have been rare reports of muscle pain, tenderness or weakness, particularly with combination anti-retroviral therapy including protease inhibitors and nucleoside analogues.
• pojavili so se tudi redki primeri bolečin v mišicah, občutljivosti ali oslabelosti, posebno ob jemanju kombiniranega protiretrovirusnega zdravljenja, vključno z zaviralci proteaz in nukleozidnimi analogi.
In the absence of such studies, caution should be exercised, as increases in nelfinavir levels and/or increases in liver enzymes may occur.
Ker takih študij ni na voljo, je potrebna previdnost, saj se lahko pojavi povečanje koncentracij nelfinavirja in/ali zvišanje koncentracij jetrnih encimov.
In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an oncogenic effect.
Odmerki do 1000 mg/kg/dan pri miših niso povzročili onkogenega učinka.
For patients unable to swallow the tablets, VIRACEPT tablets may be dispersed in a half cup of water while thoroughly stirring with a spoon.
Pri bolnikih, ki ne morejo pogoltniti tablet, se lahko VIRACEPT tablete raztopi v pol kozarca vode, pri tem pa je treba temeljito mešati z žlico.
Inhaled/nasal steroid Fluticasone
Inhalacijski/nazalen steroid flutikazon
At present, there is no evidence of inadequate efficacy of zidovudine in the CNS that could be associated with the modest reduction in plasma levels of zidovudine when coadministered with nelfinavir.
Za zdaj ni dokazov za nezadostno učinkovitost zidovudina v CŽS, ki bi jih lahko povezovali z blagim zmanjšanjem koncentracij zidovudina v plazmi ob sočasnem uživanju nelfinavirja.
See the Package Leaflet for further information.
Za nadaljne informacije glejte Navodilo za uporabo.
Overall, use of VIRACEPT in the paediatric population is associated with highly variable drug exposure.
Na splošno je uporaba zdravila VIRACEPT pri pediatrični populaciji povezana z velikimi razlikami v izpostavljenosti zdravilu.
Like all medicines, Viracept can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Viracept neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• Take all your doses at the right time each day.
• Odmerke jemljite vsak dan ob pravem času.
VIRACEPT is administered orally and should always be ingested with food (see section 5.2).
Zdravilo VIRACEPT je treba jemati peroralno in vedno skupaj s hrano (glejte poglavje 5.2).
The EC95 (95 % effective concentration) of nelfinavir ranged from 7 to 111 nM (mean of 58 nM).
EC95 (95 % učinkovita koncentracija) nelfinavirja je bila v območju 7 do 111 nM (srednja vrednost 58 nM).
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Treba je razmisliti še o merjenju serumskih lipidov in krvnega sladkorja na tešče.
Children and neonates:
Otroci in novorojenčki
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltese insufficiency should not take this medicine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorbcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
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).
Akutna in kronična toksičnost: študije o peroralni akutni in kronični toksičnosti so opravili na miših (500 mg/kg/dan), podganah (do 1000 mg/kg/dan) in opicah (do 800 mg/kg/dan).
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.
Pri otrocih, starih med 2 in 13 let, so očistki peroralno vnešenega nelfinavirja približno 2- do 3-krat večji kot pri odraslih z večjo variabilnostjo med posamezniki.
Viracept contains a medicine called nelfinavir, which is a ‘protease inhibitor'.
Zdravilo Viracept vsebuje zdravilno učinkovino nelfinavir, ki je »zaviralec proteaz«.
The side effects seen in children are similar to those seen in adults.
Neželeni učinki, ki so jih opazili pri otrocih, so podobni tistim, ki so jih opazili pri odraslih.
Overdoses of nelfinavir could theoretically be associated with prolongation of the QT-interval of the ECG (see also section 5.3).
Preveliko odmerjanje nelfinavirja lahko teoretično povezujemo s podaljšanjem intervala Q-T v EKG (glejte tudi poglavje 5.3).
Endothelin receptor antagonists Bosentan
Antagonisti receptorjev endotelina bosentan
Distribution: Nelfinavir in serum is extensively protein-bound (≥ 98 %).
Porazdelitev: nelfinavir se v serumu v visokem odstotku (≥ 98 %) veže na beljakovine.
• If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Limited clinical trial data from patients receiving one or more of these medicinal products with nelfinavir indicated that a clinically significant effect on safety and efficacy is not expected.
Na voljo so omejeni podatki kliničnih preskušanj bolnikov, ki so sočasno z nelfinavirjem jemali eno ali več od teh zdravil, nakazujejo pa, da klinično značilen učinek na varnost in učinkovitost ni verjeten.
Clinical examination should include evaluation for physical signs of fat redistribution.
Pri kliničnih pregledih je treba oceniti telesne znake prerazporeditve maščevja.
• Low numbers of red blood cells (anaemia).
• zmanjšano število rdečih krvnih celic (anemija),
HMG-CoA reductase inhibitors (Statins)
Zaviralci reduktaze HMG-CoA (statini)
• When new information is received that may impact on the current Safety Specification,
• kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja,
Skin and subcutaneous tissue disorders: Very rare (≤ 0.01 %), including isolated reports: Erythema multiforme.
Bolezni kože in podkožja: Zelo redki (≤ 0,01 %),vključno z osamljenimi poročili: multiformni eritem.
For other substrates of CYP3A4 a dose reduction or consideration of an alternative may be required (Table 1).
Za druge substrate CYP3A4 bo potrebno zmanjšanje odmerka ali razmislek o drugih možnostih zdravljenja (Preglednica 1).
Mutagenicity: in vitro and in vivo studies with and without metabolic activation have shown that nelfinavir has no mutagenic or genotoxic activity.
Mutagenost: in vitro ter in vivo študije z aktivacijo presnove ali brez nje so pokazale, da nelfinavir ni mutagen ali genotoksičen.
Also contains colourant indigocarmine (E132) and other constituents.
Vsebuje tudi barvilo indigotin (E132) in druge pomožne snovi.
Important information about some of the ingredients of Viracept
Pomembne informacije o nekaterih sestavinah zdravila Viracept
Therefore, no special precautions or dose adjustments are required in these patients.
Previdnostni ukrepi zato pri teh bolnikih niso potrebni.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Motnje lipidov je treba ustrezno klinično obravnavati (glejte poglavje 4.8).
This may lead to a loss of virologic response and possible resistance to VIRACEPT (see section 4.5).
Zaradi tega lahko pride do izgube virološkega odziva in možne rezistence na zdravilo VIRACEPT (glejte poglavje 4.5).
Mechanism of action: HIV protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors to the individual proteins found in infectious HIV.
Mehanizem delovanja: HIV-proteaza je encim, ki proteolitsko cepi prekurzorje virusnih polibeljakovin na posamezne beljakovine, ki jih najdemo v infektivnem virusu HIV.
The clinical relevance of these findings has not been established.
Klinični pomen teh ugotovitev še ni znan.
Nelfinavir must not be administered concurrently with terfenadine, astemizole or cisapride because of the potential for serious and/or life-threatening cardiac arrhythmias.
Nelfinavir se sočasno z terfenadinom, astemizolom ali cisapridom ne sme dajati, ker obstaja možnost, da povzroči nevarne in/ali življenjsko ogrožujoče srčne aritmije.
Other possible side effects, where you should talk to your doctor If you get any of the side effects on this list, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Drugi neželeni učinki, o katerih morate obvestiti vašega zdravnika Če se pri vas pojavi katerikoli od naštetih neželenih učinkov ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
The table also shows the recommended total number of Viracept tablets that children will be given each day based on their weight.
Preglednica prav tako prikazuje priporočeno skupno število Viracept tablet, ki jih bodo otroci prejeli vsak dan glede na njihovo telesno maso.
14 2-13 years
2-13 let
• A severe form of rash (erythema multiforme).
• huda oblika izpuščaja (multiformni eritem),
Pharmacokinetic data are also available for 86 patients (age 2 to 12 years) who received VIRACEPT 25-35 mg/kg TID in Study AG1343-556.
Na voljo so tudi farmakokinetični podatki za 86 bolnikov (starih od 2 do 12 let), ki so prejemali zdravilo VIRACEPT 25 - 35 mg/kg trikrat na dan v študiji AG1343-556.
Viracept is used with other ‘anti-retroviral' medicines to:
Zdravilo Viracept se uporablja v kombinaciji z drugimi »protiretrovirusnimi« zdravili zato, da:
How much you take each time (in grams)
odmerek, ki ga vsakič vzamete (v gramih)
Although study 542 showed no statistically significant differences between the two regimens in efficacy in a predominantly antiretroviral naïve patient population, the significance of these findings for antiretroviral experienced patients is unknown.
Čeprav študija pri 542 bolnikih, pretežno še nezdravljenih s protiretrovirusnimi zdravili, ni pokazala statistično značilnih razlik med dvema režimoma odmerjanja v učinkovitosti, pa pomembnost teh ugotovitev pri bolnikih, ki so že bili zdravljeni s protiretrovirusnimi zdravili, ni znana.
If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
Če mešanica ni zaužita takoj, se lahko shranjuje v hladilniku, vendar ne več kot 6 ur.
over 22 kg * Children with these weights will be given an uneven number of tablets during the day.
nad 22 kg * Otroci s temi telesnimi masami ne bodo prejeli enakega števila tablet čez dan.
One major and several minor oxidative metabolites were found in plasma.
V plazmi so našli enega glavnega in več manj pomembnih oksidiranih presnovkov.
SPECIAL STORAGE CONDITIONS Do not store above 30°C Store in the original container
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C Shranjujte v originalnem vsebniku
The signs may include difficulty in breathing, fever, itching, swelling of the face and skin rashes that can sometimes form blisters.
Znaki lahko vključujejo težave z dihanjem, zvišano telesno temperaturo, srbež, zateklost obraza in kožne izpuščaje, ki lahko včasih povzročijo mehurje.
Many patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or hyperglycaemia.
Mnogi od teh bolnikov so imeli dodatna obolenja, nekatere od njih je bilo treba zdraviti z učinkovinami, povezanimi z razvojem sladkorne bolezni ali hiperglikemije.
Date of latest renewal: 23 January 2008
Datum zadnjega podaljšanja dovoljenja za promet: 23.1.2008
• You are allergic to nelfinavir or to any of the other ingredients (listed in Section 6 ‘Further information').
• če ste alergični (preobčutljivi) na nelfinavir ali katerokoli sestavino zdravila (naštete so v poglavju 6 »Dodatne informacije«),
In vitro: HIV isolates with reduced susceptibility to nelfinavir have been selected in vitro.
In vitro: izolati HIV z zmanjšano občutljivostjo za nelfinavir so bili izbrani in vitro.
The virological failure was greater in the nelfinavir group (17 %) than in the fosamprenavir/ritonavir group (7 %).
Virološki neuspeh je bil večji v skupini, zdravljeni z nelfinavirjem (17 %), kot v skupini, zdravljeni s fosamprenavirjem/ritonavirjem (7 %).
270 film-coated tablets
270 filmsko obloženih tablet
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.
Večje tveganje za lipodistrofijo povezujejo s posameznimi dejavniki, kot so višja starost, in z dejavniki povezanimi z zdravilom, kot je dalj časa trajajoče protiretrovirusno zdravljenje in s tem povezane presnovne motnje.
Since increased concentrations of HMG-CoA reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with nelfinavir is not recommended.
Ker povečane koncentracije zaviralcev reduktaze HMG-CoA lahko povzročijo miopatijo, vključno z rabdomiolizo, kombinacija teh zaviralcev z nelfinavirjem ni priporočljiva.
• This medicine contains aspartame, which is a source of phenylalanine.
• Zdravilo vsebuje sladilo aspartam, ki je izvor fenilalanina.
The cause and long-term health effects of these conditions are not known at this time.
Vzroki teh stanj in njihovi dolgoročni vplivi na zdravje za zdaj niso znani.
Two studies have compared the safety and efficacy of nelfinavir (unboosted) with ritonavir- boosted protease inhibitors, each in combination with other antiretroviral agents.
Dve študiji sta primerjali varnost in učinkovitost nelfinavirja (brez podporne terapije) z zaviralci proteaz ob podporni terapiji z ritonavirjem, vsakega v kombinaciji z drugimi protiretrovirusnimi učinkovinami.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo.
300 film-coated tablets
300 filmsko obloženih tablet
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.
Bolnikom moramo povedati, da zdravilo VIRACEPT ne ozdravi okužbe z virusom HIV, da se lahko razvoj okužb ali drugih bolezni, povezanih s HIV, nadaljuje, in da zdravilo VIRACEPT ne odpravi tveganja prenosa okužbe s HIV s spolnim stikom ali okuženo krvjo.
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.
Opaženo je bilo 49- do 69 % povečanje AUC nelfinavirja v skupini z motnjami jetrnega delovanja z okvaro (Child-Turcotte razredi od A do C) v primerjavi z zdravo skupino.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2.)
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glej Dodatek I: Povzetek glavnih značilnosti zdravila, 4.2).
In subjects with normal CYP2C19 activity, plasma levels of this metabolite are approximately 25 % of the total plasma nelfinavir-related concentration.
Pri bolnikih z normalno aktivnostjo CYP2C19 je raven tega presnovka v plazmi približno 25 % celotne plazemske koncentracije nelfinavirja in njegovih presnovkov.