natgillin/translations-raw huggingface dataset:
The reason for this is not known.
Vzrok tega ni znan.
Taking/using other medicines
Jemanje/uporaba drugih zdravil
Date of last renewal: 17 November 2005
Datum zadnjega podaljšanja dovoljenja za promet: 17. november 2005
• Other combinations
• Druge kombinacije
Clinical experience:
Klinične izkušnje:
For this reason, it is very important that you inform your doctor about any changes in your health.
Tako je nadvse pomembno, da svojega zdravnika obvestite prav o vsaki spremembi svojega zdravstvenega stanja.
The mechanism of this interaction remains unknown.
Mehanizem tega medsebojnega delovanja ostaja neznan.
You should keep in regular contact with your doctor.
S svojim zdravnikom morate biti v rednem stiku.
In some patients, additional factor VIII was given.
Nekateri bolniki so dodatno dobivali faktor VIII.
In children, the nature of the safety profile is similar to that seen in adults.
Pri otrocih je narava varnostnega profila podobna tistemu pri odraslih.
The clinical significance of these possible interactions is not known and has not been investigated.
Klinični pomen teh morebitnih interakcij ni znan in ga niso preučevali.
You should tell your doctor about any medical conditions that you have or have had.
Svojemu zdravniku morate povedati za vsako zdravstveno težavo, ki jo imate ali ste jo kdaj imeli.
You can still continue to develop other infections and other illnesses associated with HIV disease.
Še vedno lahko prihaja do drugih okužb in bolezni, ki so povezane z okužbo z virusom HIV.
These medicines are used for treating human immunodeficiency virus (HIV) infection.
Ta zdravila se uporabljajo za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV).
A second peak is observed after 10 to 12 hours and may represent either delayed absorption or enterohepatic recirculation.
Drugi vrh koncentracij so opazili po 10-12 urah in lahko predstavlja bodisi zapoznelo absorpcijo bodisi enterohepatično recirkulacijo.
The dose of amprenavir may need adjusting.
Odmerek amprenavirja bo morda potrebno prilagoditi.
Elimination: the plasma elimination half-life of amprenavir ranges from 7.1 to 10.6 hours.
Izločanje: Plazemski razpolovni čas izločanja znaša za amprenavir od 7,1 do 10,6 ur.
The potential risk to humans is unknown.
Možno tveganje za ljudi ni znano.
DATE OF THE REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http://www.emea.europa.eu/.
Treatment difference
Razlika v zdravljenju
The clinical relevance of these changes is unknown.
Klinični pomen teh sprememb ni poznan.
These capsules also contain sorbitol.
Kapsule vsebujejo tudi sorbitol.
On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
V redkih primerih so bile te mišične težave resne (rabdomioliza).
1.0 (range 0-2)
1,0 (razpon 0-2)
Of note, the following interaction data was obtained in adults.
Upoštevati je potrebno naslednje podatke o interakcijah, ki so bili pridobljeni pri odraslih.
BATCH NUMBER LOT
ŠTEVILKA SERIJE Lot
You should not take more than 2400 mg per day.
Na dan pa ne smete vzeti več kot 2400 mg.
Pregnancy: there are no adequate data from the use of amprenavir in pregnant women.
Nosečnost: Ni zadostnih podatkov o uporabi amprenavirja pri nosečnicah.
Amprenavir did not affect fertility.
Amprenavir ni prizadel plodnosti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 2000
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 20. oktober 2000
The mechanism for the hepatocellular adenomas and carcinomas found in these studies has not been elucidated and the significance of the observed effects for humans is uncertain.
Mehanizem nastanka hepatocelularnih adenomov in karcinomov, ki so bili ugotovljeni v teh študijah, ni pojasnjen, pomen opaženih učinkov pa je za človeka nezanesljiv.
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
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
If you forget to take a dose of Agenerase, take it as soon as you remember and then continue as before.
Če ste pozabili vzeti odmerek zdravila Agenerase, ga vzemite takoj, ko se spomnite, in nato nadaljujte kakor poprej.
• Swelling of the face, lips and tongue (angioedema)
• Otekanje obraza, ustnic in jezika (angioedem).
Clearance also decreased in a corresponding manner to the AUC.
V ustreznem razmerju z AUC se je zmanjšal tudi očistek.
Note that the background rates in comparator groups were not taken into account.
Upoštevati je potrebno, da podatki primerjalnih skupin niso všteti.
In some of these, the hyperglycaemia was severe and in some cases also associated with ketoacidosis.
Pri posameznikih je bila hiperglikemija huda in v nekaterih primerih povezana s ketoacidozo.
Elevations in cholesterol were of grade 3-4 intensity.
Zvišanje vrednosti holesterola je bilo stopnje 3-4.
(−21, 9)c a Intent To Treat (Exposed) Population: Observed analysis b Mean stratified difference c 95% confidence interval
(−21, 9)c a Vključeni (izpostavljeni) bolniki: opazovalna analiza b Srednja stratificirana razlika c 95 % interval zaupanja
Median number of PI primary mutations 1
Srednje število primarnih mutacij PIjev 1
This medicinal product should be used during pregnancy only after careful weighing of the potential benefits compared to the potential risk to the foetus.
Zdravilo se sme med nosečnostjo uporabljati le po temeljitem razmisleku o potencialnih koristih v primerjavi s potencialnim tveganjem za plod.
Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Izsledki o pomenu določenih mutacij ali mutacijskih vzorcev so predmet dopolnjevanja z dodatnimi podatki, zato priporočamo, da pri analiziranju rezultatov rezistenčnih testov vedno upoštevate najnovejše interpretacijske sisteme.
Do not take a double dose to make up for forgotten individual doses.
Ne vzemite dvojnega odmerka, da bi nadoknadili pozabljeni posamični odmerek.
Appropriate precautions should continue to be taken.
Še naprej je potrebno kontinuirano skrbeti za ustrezne varnostne ukrepe.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki s hereditarno intoleranco za fruktozo tega zdravila ne smejo jemati.
In pregnant mice, rabbits and rats there were no major effects on embryo-foetal development.
Pri brejih miših, podganah in kunčicah ni bilo večjih učinkov na embriofetalni razvoj.
Other possible interactions
Druge možne interakcije
The absolute bioavailability is unknown due to the lack of an acceptable intravenous formulation for use in man.
Absolutna biološka uporabnost ni znana zaradi pomanjkanja primerne intravenske oblike, ki bi jo lahko uporabljali pri ljudeh.
No studies on the effects on ability to drive and use machines have been performed (see section 4.8).
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene (glejte poglavje 4.8).
Clinical examination should include evaluation for physical signs of fat redistribution.
Klinični pregled mora obsegati oceno telesnih znakov prerazdelitve maščevja.
• A severe or life-threatening skin reaction (Stevens Johnson syndrome)
• Hude ali smrtno nevarne kožne reakcije (Stevens-Johnsonov sindrom).
Antibiotics/antifungals
Antibiotiki/antimikotiki
Do not take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, da bi nadoknadili pozabljeni odmerek.
If your liver disease is severe you must not use this combination.
Če imate hudo jetrno bolezen, takšne kombinacije ne smete uporabljati.
• Moodiness, depression, difficulty sleeping, loss of appetite
• Slabovoljnost, depresija, težave s spanjem, izguba apetita.
The concentration of amprenavir in the cerebrospinal fluid is less than 1 % of plasma concentration.
Koncentracija amprenavirja v cerebrospinalni tekočini znaša manj kot 1 % njegove plazemske koncentracije.
Toxicity studies in young animals, treated from four days of age, resulted in high mortality in both the control animals and those receiving amprenavir.
Študije toksičnosti pri mladičih, ki so dobivali zdravila od četrtega dneva starosti, so pokazale visoko stopnjo umrljivosti tako pri živalih v kontrolni skupini kot pri tistih, ki so prejemale amprenavir.
While administration of amprenavir with food results in a 25 % reduction in AUC, it had no effect on the concentration of amprenavir 12 hours after dosing (C12).
Čeprav zaužitje amprenavirja s hrano zmanjša AUC za 25 %, hrana nima vpliva na koncentracijo amprenavirja 12 ur po zaužitju odmerka (C12).
In this situation, a reduced dose of atorvastatin should be considered.
V tem primeru je potrebno razmisliti o zmanjšanju odmerka atorvastatina.
Associations contraindicated (see section 4.3)
Povezave s kontraindikacijami (glejte poglavje 4.3)
Lactation: amprenavir-related material was found in rat milk, but it is not known whether amprenavir is excreted in human milk.
Dojenje: V podganjem mleku so zasledili amprenavirju sorodne snovi, vendar ni znano, ali se amprenavir izloča v človeško mleko.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
V primeru sočasnega protivirusnega zdravljenja hepatitisa B ali C je potrebno upoštevati tudi relevantne podatke o teh zdravilih.
SOC PI (n = 83): Indinavir / RTV (29%) Lopinavir / RTV (36%) Saquinavir / RTV(20%)
Standardno zdravljenje s PI-ji (n = 83): Indinavir / RTV (29 %) Lopinavir / RTV (36 %) Sakvinavir / RTV(20 %)
Analyses based on genotypic resistance testing.
Analize na osnovi genotipskega testiranja rezistence
In in vitro studies, the protein binding of amprenavir is approximately 90 %.
V in vitro študijah je vezava amprenavirja na proteine približno 90 %.
A 20 ml measuring cup is provided, to help you measure out the correct amount of oral solution for each dose.
Zdravilu je priložen 20 ml merilni lonček, ki vam bo pomagal pri odmerjanju pravilnih količin peroralne raztopine vsakega odmerka.
Glycerol can cause headache, stomach upset and diarrhoea.
Glicerol lahko povzroči glavobol, želodčne motnje in drisko.
Agenerase may interact with other medicines that you are taking, so it is important that you read the next section “Taking/using other medicines” before taking this medicine.
Učinek zdravila Agenerase se lahko prepleta z učinki drugih zdravil, ki jih jemljete, zato je pomembno, da, preden vzamete to zdravilo, preberete poglavje “Jemanje/uporaba drugih zdravil” v nadaljevanju tega navodila.
If you forget to take Agenerase
Če ste pozabili vzeti zdravilo Agenerase
Itraconazole concentrations are expected to increase in the same manner as ketoconazole.
Pričakuje se, da bi se koncentracije itrakonazola zvišale podobno kot koncentracije ketokonazola.
Limited experience with Agenerase oral solution indicate a similar safety profile as for the capsules.
Omejene izkušnje s peroralno raztopino Agenerase indicirajo podoben varnostni profil, kot je pri kapsulah.
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Če se pri takšnih bolnikih pojavijo znaki poslabšanja jetrne bolezni, je potrebno razmisliti o začasni prekinitvi ali dokončni ukinitvi zdravljenja.
They can be taken with or without food.
Lahko jih jemljete skupaj s hrano ali brez nje.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Razmisliti je treba o prilagoditvi odmerka midazolama, še posebej v primeru, če je potreben več kakor en odmerek midazolama.
Amprenavir is primarily bound to the alpha-1-acid glycoprotein (AAG), but also to albumin.
Amprenavir se primarno veže na kisli glikoprotein alfa-1 (AAG), vendar tudi na albumin.
• Glaxo Operations UK Limited, trading as Glaxo Wellcome Operations Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom Manufacturing authorisation issued on 30 June 1995 by the Medicine Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, United Kingdom.
• Glaxo Operations UK Limited, trži Glaxo Wellcome Operations Priory Street, Ware, Hertfordshire SG12 ODJ, Velika Britanija Dovoljenje za izdelavo zdravila izdano 30. junija 1995 s strani Medicine Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, Velika Britanija.
• Skin Rashes (red, raised or itchy) - Occasionally, the skin rash may be severe and you may have to stop taking this medicine.
• Kožni izpuščaj (rdeč, privzdignjen nad nivo kože ali srbeč).Kožni izpuščaj je lahko občasno tudi hud in morda boste morali prenehati jemati to zdravilo.
- Please speak with your doctor if you have a history of liver disease.
- S svojim zdravnikom se pogovorite, če ste kdaj imeli jetrno bolezen.
Clinical efficacy and safety have not been determined in this patient group.
Pri tej skupini bolnikov klinična učinkovitost in varnost nista bili dognani.
Amprenavir is a competitive inhibitor of HIV-1 protease.
Amprenavir je kompetitivni zaviralec proteaze virusa HIV-1.
The relationship between in vitro anti-HIV-1 activity of amprenavir and the inhibition of HIV-1 replication in humans has not been defined.
Povezava med protiHIV-1 aktivnostjo amprenavirja in vitro in inhibicijo replikacije HIV-1 pri človeku ni bila določena.
Do not stop taking your medicine without first talking to your doctor.
Zdravila ne smete prenehati jemati, ne da bi se prej posvetovali s svojim zdravnikom.
This medicine helps to control your condition, but it is not a cure for HIV infection.
To zdravilo sicer pomaga obvladovati vašo bolezen, vendar pa okužbe z virusom HIV ne ozdravi.
Ask your doctor or pharmacist before taking any medicine.
Posvetujte se z zdravnikom ali s farmacevtom preden vzamete katero koli zdravilo.
The effects of high fluticasone systemic exposure on ritonavir plasma levels is yet unknown.
Učinki visoke sistemske izpostavljenosti flutikazonu na vrednosti ritonavirja v plazmi trenutno še niso znani.
In the event of overdosage, monitoring and management of acid-base abnormalities are recommended.
V primeru prevelikega odmerjanja je priporočeno nadziranje in uravnavanje acido-baznih nepravilnosti.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO Navedba smiselno ni potrebna.
No studies on the effects of Agenerase on the ability to drive and use machines have been done.
Študije o učinkih zdravila Agenerase na sposobnost vožnje in upravljanje vozil in strojev niso bile izvedene.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Middlesex UB6 ONN United Kingdom
Middlesex UB6 ONN Velika Britanija
The cause and long-term health effects of these conditions are not known at this time.
Vzrok takšnih sprememb in njihovi dolgotrajni učinki na zdravstveno stanje trenutno niso poznani.
Ritonavir also inhibits CYP2D6 and induces CYP3A4, CYP1A2, CYP2C9 and glucuronosyl transferase.
Ritonavir tudi zavira CYP2D6 in je induktor CYP3A4, CYP1A2, CYP2C9 ter glukuronozil transferaze.
Anticonvulsants (carbamazepine, phenobarbital, phenytoin) should be used with caution.
Antiepileptike (karbamazepin, fenobarbital, fenitoin) je treba uporabljati previdno.
The safe use of Agenerase in pregnancy has not been established.
Varnost uporabe zdravila Agenerase med nosečnostjo ni bila ugotovljena.
Appropriate antihistamines (e.g. cetirizine dihydrochloride) may reduce pruritus and hasten the resolution of rash.
Ustrezen antihistaminik (npr. cetirizinijev diklorid) lahko omili srbež in pospeši resolucijo izpuščaja.
The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).
Izbira amprenavirja mora temeljiti na individualnem testiranju virusne rezistence in podatkih predhodnega zdravljenja bolnikov (glejte poglavje 5.1).
Paediatrics: the pharmacokinetics of amprenavir in children (4 years of age and above) are similar to those in adults.
Pediatrija: Farmakokinetične lastnosti zdravila Agenerase pri otrocih (starejših od 4 let) so podobne tistim pri odraslih.
Very common Common Uncommon Rare
Zelo pogosti Pogosti Občasni Redki
However, there is little evidence from the exposure data in humans, both in clinical trials and from marketed use, to suggest that these findings are of clinical significance.
Ne glede na vse je iz podatkov o izpostavi človeka tako v kliničnih študijah kot pri redni uporabi malo dokazov, ki bi nakazovali, da imajo navedene ugotovitve klinični pomen.
Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
V primeru ukinitve kortikosteroida bo odmerek morda treba postopno zmanjševati daljši čas.
Each of these four genetic patterns associated with reduced susceptibility to amprenavir produces some cross-resistance to ritonavir but susceptibility to indinavir, nelfinavir and saquinavir is generally retained.
Vsak od teh štirih genetskih vzorcev, ki so povezani z zmanjšano občutljivostjo za amprenavir, povzroča tudi določeno stopnjo navzkrižne odpornosti na ritonavir, občutljivost za indinavir, nelfinavir in sakvinavir pa se običajno ohrani.
Patients should be advised that Agenerase, or any other current antiretroviral therapy does not cure HIV and that they may still develop opportunistic infections and other complications of HIV infection.
Bolnike je potrebno opozoriti, da zdravilo Agenerase ali katero koli drugo trenutno razpoložljivo protiretrovirusno zdravljenje ne ozdravi okužbe z virusom HIV, zato so še vedno možne oportunistične okužbe in drugi zapleti, povezani z okužbo z virusom HIV.
However, the possibility of anaphylactic reaction related to PEG 400 cannot be excluded.
Vendar možnosti anafilaksijske reakcije povezane s PEG 400 ni mogoče izključiti.
- If you have had liver disease discuss this with your doctor.
- Če ste kdaj imeli jetrno bolezen, se o tem pogovorite s svojim zdravnikom.
The dosage should therefore be reduced in these patients (see section 4.2).
Takšnim bolnikom je torej potrebno odmerke zmanjšati (glejte poglavje 4.2).
In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
V več kot polovici poročanih primerov zdravljenje z zaviralci proteaz ni bilo prekinjeno ali pa se je po prekinitvi nadaljevalo.
Agenerase belongs to a group of antiviral medicines called protease inhibitors.
Zdravilo Agenerase pripada skupini protivirusnih zdravil, ki se imenujejo zaviralci proteaz.
There are currently data on cross-resistance between amprenavir and other protease inhibitors for all 4 fosamprenavir resistance pathways, either alone or in combination with other mutations.
Podatki o navzkrižni odpornosti med amprenavirjem in drugimi zaviralci proteaz so za vse štiri mehanizme odpornosti fosamprenavirja, same ali v kombinaciji z drugimi mutacijami.
You should not take more than 2800 mg per
Na dan pa ne smete vzeti več kot 2800 mg.
Because of the potential for metabolic interactions with amprenavir, the efficacy of hormonal contraceptives may be modified, but there is insufficient information to predict the nature of the interactions.
Ker obstaja možnost presnovnih interakcij z amprenavirjem, se lahko spremeni učinkovitost hormonskih kontraceptivov, vendar za predvidenje narave takšnih interakcij ni na razpolago dovolj podatkov.
Propylene glycol can be removed by hemodialysis.
Propilenglikol se lahko odstrani s hemodializo.
- Patients of 4 years of age and older unable to swallow capsules: The dose will be calculated according to your weight by your doctor.
- Bolniki, stari 4 leta in starejši, ki ne zmorejo pogoltniti kapsul: Glede na vašo težo bo odmerek preračunal zdravnik.
St John's wort (Hypericum perforatum)
Šentjanževka (Hypericum perforatum)
However, this increase was not statistically significantly different from male control mice by appropriate tests.
Kljub temu pa je bilo z ustreznimi testi ugotovljeno, da se to povišanje statistično značilno ne razlikuje od kontrolne populacije mišjih samcev.
Distribution: the apparent volume of distribution is approximately 430 litres (6 l/kg assuming a 70 kg body weight), suggesting a large volume of distribution, with penetration of amprenavir freely into tissues beyond the systemic circulation.
Porazdelitev: Navidezni volumen porazdelitve znaša približno 430 litrov (6 l/kg pri telesni masi 70 kg), kar nakazuje na obsežen volumen porazdelitve in zmožnost prostega prehajanja amprenavirja v tkiva izven sistemske cirkulacije.
- In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
- Pri nekaterih bolnikih z napredovalo okužbo s HIV (AIDS) in z oportunistično okužbo v anamnezi se lahko kmalu po začetku anti-HIV zdravljenja pojavijo znaki in simptomi vnetja povezani s prejšnjimi okužbami.
It might also be necessary to reconsider the treatment with Agenerase oral solution.
Morda bo tudi potrebno ponovno preveriti upravičenost zdravljenja s peroralno raztopino Agenerase.
Before starting treatment with Agenerase, please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Preden se pričnete zdraviti z zdravilom Agenerase, obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
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 je bilo povezano z individualnimi dejavniki, kot je višja starost, ter z od zdravila odvisnimi dejavniki, kot je dolgotrajnejše protiretrovirusno zdravljenje, in z njimi povezanimi presnovnimi motnjami.
Amprenavir binds to the active site of HIV-1 protease and thereby prevents the processing of viral gag and gag-pol polyprotein precursors, resulting in the formation of immature non-infectious viral particles.
Amprenavir se veže na aktivno mesto proteaze virusa HIV-1 in tako prepreči nastajanje virusnih gag in gag-pol poliproteinskih predhodnikov, kar ima za posledico tvorbo nezrelih in nekužnih virusnih delcev.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Agenerase capsules also contain sorbitol (E420).
Kapsule Agenerase vsebujejo tudi sorbitol (E420).
The impact of renal impairment on amprenavir elimination should be minimal therefore, no initial dose adjustment is considered necessary.
Vpliv oslabljenega delovanja ledvic na izločanje amprenavirja je minimalen, zato prilagajanje začetnega odmerka ni potrebno.
480 soft capsules
480 mehkih kapsul
No dose recommendations can be made regarding this combination.
Za takšno kombinacijo ne moremo podati priporočenih odmerkov.
The evidence of efficacy of unboosted Agenerase was based on two uncontrolled clinical studies involving 288 HIV infected children aged between 2 and 18 years, 152 of whom were PI experienced.
Dokaz učinkovitosti zdravila Agenerase brez okrepitve temelji na dveh nenadzorovanih kliničnih študijah, v kateri je bilo vključenih 288 z virusom HIV okuženih otrok, starih od 2 do 18 let.