natgillin/translations-raw huggingface dataset:
Through 48 weeks of therapy, a statistically significantly higher proportion of patients in the lopinavir/ritonavir arm had HIV-1 RNA < 50 copies/ml compared to the nelfinavir arm.
V obdobju 48- tedenskega zdravljenja je imelo HIV- 1 RNK < 50 kopij/ ml statistično značilno večji delež bolnikov v skupini, zdravljeni z lopinavirjem/ ritonavirjem, v primerjavi s skupino, zdravljeno z nelfinavirjem.
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).
Študija APV3002 je randomizirana, preskušanje je odprto s 649 bolniki z napredovalo boleznijo HIV, ki še niso bili zdravljeni s protiretrovirusnimi učinkovinami, in preiskuje zdravljenje s fosamprenavirjem/ ritonavirjem (1400 mg/ 200 mg enkrat na dan, n = 322) v primerjavi z nelfinavirjem (1250 mg dvakrat na dan, n = 327), vsakega v kombinaciji z lamivudinom (150 mg dvakrat na dan in abakavirjem (300 mg dvakrat na dan).
Median baseline HIV-1 RNA was 4.8 log10 copies/ml in both treatment groups.
Mediana začetne vrednosti HIV- 1 RNK je bila 4, 8 log10 kopij/ ml v obeh skupinah.
Median baseline CD4+ cell counts were 177 and 166 x106 cells/l for the nelfinavir and fosamprenavir/ritonavir groups respectively.
Mediana začetne vrednosti števila celic CD4+ je bila 177 x 106 celic/ l v skupini, zdravljeni z nelfinavirjem, in 166 x 106 celic/ l v skupini, zdravljeni s fosamprenavirjem/ ritonavirjem.
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).
V 48. tednu je 68% bolnikov v skupini, zdravljeni z nelfinavirjem, in 69% bolnikov, zdravljenih s fosamprenavirjem/ ritonavirjem, imelo koncentracijo HIV- 1 RNK v plazmi < 400 kopij/ ml, kar je kazalo na enakost med skupinama, medtem ko je imelo 53% bolnikov v skupini, zdravljeni z nelfinavirjem, in 55% bolnikov v skupini, zdravljeni s fosamprenavirjem/ ritonavirjem, HIV- 1 RNK < 50 kopij/ ml (namen zdravljenja, ponoven pojav/ ukinitev = neuspeh).
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.
Mediana povečanja števila celic CD4+ od začetne vrednosti v 48 tednih je bila 207 celic/ mm3 v skupini, zdravljeni z nelfinavirjem, in 203 celic/ mm3 v skupini, zdravljeni s fosamprenavirjem/ ritonavirjem.
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%).
Treatment emergent NRTI resistance was significantly less frequent with fosamprenavir/ritonavir compared to nelfinavir (13% versus 57%; p < 0.001).
Odpornost proti potrebnemu zdravljenju z nukleozidnimi analogi zaviralcev reverzne transkriptaze (nucleoside analogue reverse transcriptase inhibitors – NRTI) je bilo značilno manj pogosto pri fosamprenavirju/ ritonavirju v primerjavi z nelfinavirjem (13% v primerjavi s 57%; p < 0, 001).
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.
Absorpcija: po enkratnih ali večkratnih peroralnih odmerkih 500 do 750 mg (dve do tri 250- mg tablete), zaužitih s hrano, so bile največje koncentracije nelfinavirja v plazmi dosežene v 2 do 4 urah.
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.
Po večkratnem odmerjanju s 750 mg vsakih 8 ur 28 dni (stanje dinamičnega ravnovesja), so znašale največje koncentracije v plazmi (Cmax) v povprečju 3 do 4 μg/ ml, pred naslednjim odmerkom pa 1 do 3 μg/ ml.
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.
V farmakokinetični študiji pri HIV- pozitivnih bolnikih so primerjali večkratne odmerke 1. 250 mg dvakrat na dan z večkratnimi odmerki 750 mg trikrat na dan 28 dni.
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.
Pri bolnikih, ki so prejemali zdravilo VIRACEPT dvakrat na dan (n = 10), je bila Cmax nelfinavirja v plazmi 4, 0 ± 0, 8 μg/ ml, najnižje koncentracije v plazmi pred naslednjim odmerkom zjutraj 2, 2 ± 1, 3 μg/ ml in zvečer 0, 7 ± 0, 4 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.
Pri bolnikih (n = 11), ki so zdravilo VIRACEPT prejemali trikrat na dan, so bile največje koncentracije nelfinavirja v plazmi (Cmax) 3, 0 ± 1, 6 μg/ ml, najnižje koncentracije pred naslednjim odmerkom zjutraj 1, 4 ± 0, 6 μg/ ml in zvečer 1, 0 ± 0, 5 μg/ ml.
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.
Razliko med jutranjimi in popoldanskimi ali večernimi najnižjimi koncentracijami pred naslednjim odmerkom pri odmerjanju trikrat in dvakrat na dan so opazili tudi pri zdravih prostovoljcih, ki so prejeli odmerek v točno določenih 8 - ali 12 - urnih intervalih.
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).
Najnižja
Trough drug exposures remain at least twenty fold greater than the mean IC95 throughout the dosing interval for both regimens.
15 izpostavljenost zdravilu tik pred ponovnim odmerkom je bila vsaj dvajsetkrat večja kot srednja IC95 skozi celoten dozirni interval za obe shemi odmerjanja.
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.
Učinek hrane na črevesno absorpcijo: največje plazemske koncentracije in površina pod krivuljo koncentracija– čas v plazmi so bile stalno 2 - do 3- krat večje ob jemanju s hrano v primerjavi z uživanjem zdravila na tešče.
The increased plasma concentrations with food were independent of fat content of the meals.
Povečane koncentracije v plazmi pri jemanju s hrano niso odvisne od odstotka maščob v obrokih.
The effect of meal content on nelfinavir exposure was investigated in a study using the 250 mg film-coated tablets formulation.
Vpliv sestave obroka na izpostavljenost nelfinavirja so proučevali v študiji z uporabo 250 mg filmsko obloženih tablet.
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
AUC in Cmax v stanju dinamičnega ravnovesja so bile za 15% višje, če so bolniki zaužili obrok s 800 kcal/ 50% maščob in za 20% višje, če so zraven zaužili lahek obrok (350 kcal/ 33% maščob).
15 (350 kcal/33% fat), suggesting that meal content has less effect on nelfinavir exposures during multiple dosing than would be anticipated based on data from single dose studies.
To nakazuje, da ima sestava obroka manjši vpliv na izpostavljenost nelfinavirja med večkratnim odmerjanjem, kot je bilo sklepano na osnovi podatkov študij enkratnega odmerjanja.
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.
Porazdelitev: pri živalih in ljudeh so ocenjeni volumni porazdelitve (2 do 7 l/ kg) presegali volumen celotne telesne tekočine, kar nakazuje obsežno prehajanje nelfinavirja v tkiva.
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.
Čeprav pri ljudeh študij niso izvajali, so študije pri podganah pokazale, da so bile koncentracije v možganih po enkratnem odmerku 50 mg/ kg nelfinavirja 14C nižje kot v drugih tkivih, vendar so presegle in vitro EC95 za protivirusno delovanje.
Nelfinavir in serum is extensively protein-bound (≥ 98%).
Nelfinavir se v serumu v visokem odstotku (≥ 98%) veže na beljakovine.
Metabolism: unchanged nelfinavir comprised 82-86% of the total plasma radioactivity after a single oral 750 mg dose of 14C-nelfinavir.
Presnova: po enkratnem peroralnem odmerku 750 mg nelfinavirja 14C znaša delež celotne plazemske radioaktivnosti za nespremenjeni nelfinavir 82 do 86%.
One major and several minor oxidative metabolites were found in plasma.
Nelfinavir se in vitro presnavlja z več izoencimi citokroma P- 450, vključno s CYP3A, CYP2C19/ C9 in CYP2D6. V plazmi so našli enega glavnega in več manj pomembnih oksidiranih presnovkov.
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.
Glavni oksidirani presnovek, M8 (terc- butil hidroksinelfinavir), ima in vitro enako protivirusno aktivnost kot učinkovina, njegovo tvorbo katalizira polimorfni citokrom CYP2C19.
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.
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.
Pričakovati je, da bodo pri bolnikih s slabo aktivnostjo CYP2C19 ali pri bolnikih, ki sočasno prejemajo močne zaviralce CYP2C19 (glejte poglavje 4. 5), plazemske koncentracije nelfinavirja zvišane, koncentracije terc- butil hidroksinelfinavirja pa zanemarljivo nizke ali celo nemerljive.
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.
Omejeni klinični podatki nakazujejo, da bolniki z zelo nizkimi ali nemerljivimi plazemskimi koncentracijami presnovka in zvišanimi koncentracijami nelfinavirja ne kažejo zmanjšanega virološkega odziva ali drugačnega varnostnega profila v primerjavi s celotno študijsko populacijo.
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.
Izločanje: ocene očistka po peroralnih enkratnih odmerkih (24 do 33 l/ h) in večkratnih odmerkih (26 do 61 l/ h) nakazujejo srednje do veliko biološko uporabnost nelfinavirja v jetrih.
The terminal half-life in plasma was typically 3.5 to 5 hours.
Končna razpolovna doba v plazmi je 3, 5 do 5 ur.
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%).
Večina (87%) peroralnega 750- mg odmerka, ki vsebuje nelfinavir 14C, se je izločila z blatom; celotna radioaktivnost v blatu sestoji iz 22% nelfinavirja in 78% številnih oksidiranih presnovkov.
Only 1-2% of the dose was recovered in urine, of which unchanged nelfinavir was the major component.
Le 1 do 2% odmerka se izloči z urinom, največ kot nespremenjeni nelfinavir.
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.
Farmakokinetika pri posebnih kliničnih primerih Farmakokinetika pri otrocih in starejših: 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.
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.
Po jemanju peroralnega praška ali tablet VIRACEPT s hrano v odmerkih po približno 25 do 30 mg/ kg trikrat na dan, so bile plazemske koncentracije v stanju dinamičnega ravnovesja podobne koncentracijam pri odraslih bolnikih, ki so prejemali 750 mg zdravila trikrat na dan.
In an open prospective study, the pharmacokinetics of BID and TID VIRACEPT regimens in 18 HIV infected children aged 2-14 years were investigated.
V odprti prospektivni študiji, ki je vključevala 18 otrok, starih od 2 do 14 let in okuženih z virusom HIV, so proučevali farmakokinetične lastnosti zdravila VIRACEPT pri odmerjanju dvakrat in trikrat
Children weighing less than 25 kg received 30-37 mg/kg nelfinavir TID or 45-55 mg/kg nelfinavir BID.
Otroci z manj kot 25 kg telesne mase so prejemali 30 do 37 mg/ kg nelfinavirja trikrat na dan ali 45 do 55 mg/ kg nelfinavirja dvakrat na dan.
Children over 25 kg received 750 mg TID or 1250 mg BID.
Otroci z več kot 25 kg telesne mase so prejemali 750 mg nelfinavirja trikrat na dan ali 1. 250 mg nelfinavirja dvakrat na dan.
The Cmin, Cmax and AUC0-24 were all significantly higher with the BID regimen compared with the TID regimen.
Cmin, Cmax in AUC0- 24 so bile pri odmerjanju dvakrat na dan v primerjavi z odmerjanjem trikrat na dan signifikantno večje.
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.
Pri odmerjanju dvakrat na dan je 14 od 18 (78%) bolnikov in 11 od 18 (61%) bolnikov doseglo vrednosti Cmin 1 do 3 μg/ ml in vrednosti Cmax 3 do 4 μg/ ml; pri odmerjanju trikrat na dan pa je te vrednosti doseglo le 4 od 18 (22%) in 7 od 18 (39%) bolnikov.
Pharmacokinetics in patients with liver impairment:
Farmakokinetika pri bolnikih z jetrno okvaro:
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.
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.
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.
Kalijevi kanalčki hERG so bili 20% inhibirani pri koncentracijah nelfinavirja, ki so bile 4 - do 5- krat višje, in koncentracijah M8, ki so bile 70- krat višje od povprečnih terapevtskih koncentracij pri ljudeh.
By contrast, no effects suggesting prolongation of the QT-interval of the ECG were observed at similar doses in dogs or in isolated cardiac tissue.
V nasprotju pa pri podobnih odmerkih pri psih ali v izoliranem srčnem tkivu niso opazili vplivov na podaljšanje intervala Q- T v EKG- ju.
However, based on data from products known to prolong the QT-interval, a block of hERG potassium channels of > 20% may be clinically relevant.
Vendar pa je na podlagi podatkov zdravil, ki podaljšajo interval Q- T, blokiranje kalijevih kanalčkov hERG za > 20% lahko klinično pomembno.
Therefore the potential for QT prolongation should be considered in cases of overdose (see section 4.9).
Zato je pri prevelikem odmerjanju treba upoštevati možnost Q- T podaljšanja (glejte poglavje 4. 9).
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 1. 000 mg/ kg/ dan) in opicah (do 800 mg/ kg/ dan).
Two year oral carcinogenicity studies with nelfinavir mesilate were conducted in mice and rats.
Karcinogenost: pri miših in podganah so izvedli dvoletne študije karcinogenosti s peroralnim nelfinavirjevim mesilatom.
In mice, administration of up to 1000 mg/kg/day did not result in any evidence for an oncogenic effect.
Odmerki do 1. 000 mg/ kg/ dan pri miših niso povzročili onkogenega učinka.
In rats administration of 1000 mg/kg/day resulted in increased incidences of thyroid follicular cell adenoma and carcinoma, relative to those for controls.
Pri podganah se je pri dajanju 1. 000 mg/ kg/ dan pojavila zvečana pogostnost folikularnega celičnega adenoma in karcinoma ščitnice v primerjavi s kontrolno skupino.
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.
Administration of 300 mg/kg/day resulted in an increased incidence of thyroid follicular cell adenoma.
Dajanje 300 mg/ kg/ dan je povzročilo porast pogostnosti folikularnega celičnega adenoma ščitnice.
- microcrystalline cellulose
- mikrokristalno celulozo,
- maltodextrin
- maltodekstrin,
- dibasic potassium phosphate
- kalijev hidrogenfosfat,
- crospovidone
- krospovidon,
- hydroxypropyl methylcellulose
- hipromelozo,
- aspartame (E951)
- aspartam (E951),
- sucrose palmitate
- saharozo palmitat
- natural and artificial flavour
- naravno ter umetno aromo.
This medicinal product must not be mixed with acidic substances due to taste (see section 4.2).
Zdravila zaradi okusa ne smemo mešati s kislimi snovmi (glejte poglavje 4. 2).
17 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
Peroralni prašek VIRACEPT 50 mg/ g je na voljo v plastičnih vsebnikih HDPE, opremljenih z za otroke varnimi polipropilenskimi zaporkami s polietilensko podlogo.
Each bottle contains 144 grams of oral powder and is supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop.
Vsak vsebnik vsebuje 144 g peroralnega praška, priloženi sta še bela 1- g in modra 5- g polipropilenska merica.
There are two scoops provided in the box, a white 1 gram scoop and a blue 5 gram scoop.
1.
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
Priporočeno je, da prašek, pripravljen kot je opisano pod točko 2, uporabite v šestih urah.
22 January 1998 Date of latest renewal:
22. 1. 1998 Datum zadnjega podaljšanja dovoljenja za promet:
23 January 2008
23. 1. 2008
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).
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.
Bolniki, starejši od 13 let: priporočeni odmerek filmsko obloženih tablet VIRACEPT je 1. 250 mg (pet 250- mg tablet) dvakrat na dan ali 750 mg (tri 250 mg tablete) trikrat na dan peroralno.
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).
Učinkovitost odmerjanja dvakrat na dan v primerjavi z odmerjanjem trikrat na dan so proučevali v glavnem pri bolnikih, ki se še niso zdravili s PI (glejte poglavje 5. 1).
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.
Bolniki, stari 3 do 13 let: za otroke je priporočeni začetni odmerek 50 do 55 mg/ kg telesne mase dvakrat na dan ali 25 do 30 mg/ kg telesne mase trikrat na dan.
For children unable to take tablets, VIRACEPT oral powder may be administered (see Summary of Product Characteristics for VIRACEPT oral powder).
Otroci, ki niso zmožni jemati tablet, lahko zaužijejo peroralni prašek VIRACEPT (glejte Povzetek glavnih značilnosti za peroralni prašek VIRACEPT).
The recommended dose of VIRACEPT film-coated tablets to be administered BID to children aged 3 to 13 years is as follows:
20 Priporočeni odmerek filmsko obloženih tablet VIRACEPT za otroke, stare od 3 do 13 let, pri odmerjanju dvakrat na dan je:
Body
Telesna masa
Number of VIRACEPT 250 mg film-coated tablets per dose*
VIRACEPT 250 mg na odmerek *
to < 22 ≥ 22
do < 22 ≥ 22
19 The recommended dose of VIRACEPT film-coated tablets to be administered TID to children aged 3 to 13 years is as follows:
Priporočeni odmerek filmsko obloženih tablet VIRACEPT za otroke, stare od 3 do 13 let, pri odmerjanju trikrat na dan je:
to < 23 ≥ 23
do < 23 ≥ 23
*see Summary of Product Characteristics for VIRACEPT oral powder for patients with less than 18 kg body weight.
* Glejte Povzetek glavnih značilnosti za peroralni prašek VIRACEPT za bolnike z manj kot 18 kg telesne mase.
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].
Sočasno jemanje z zdravili, ki imajo ozko terapevtsko okno in ki so substrati za CYP3A4 (npr. terfenadin, astemizol, cisaprid, amiodaron, kvinidin, pimozid, triazolam, peroralno dan midazolam (za previdnost pri parenteralnih oblikah midazolama glejte poglavje 4. 5), derivati ergot; glejte poglavje 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).
Pripravki rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), se med jemanjem nelfinavirja ne smejo uporabljati, ker se lahko zmanjšata koncentracija nelfinavirja v plazmi in njegov terapevtski učinek (glejte poglavje 4. 5).
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Sindrom imunske reaktivacije: pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy")
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ ali žariščne okužbe z mikobakterijami in s Pneumocystis carinii povzročena pljučnica.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be
Bolniki s predhodno jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo pri kombiniranem protiretrovirusnem zdravljenju povečano pogostnost nepravilnosti jetrne funkcije.
20 monitored according to standard practice.
Treba jih je spremljati v skladu s standardno prakso.