natgillin/translations-raw huggingface dataset:
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s wort (see section 4.3).
Inducirajoči učinek lahko vztraja še najmanj 2 tedna po opustitvi zdravljenja s pripravki iz šentjanževke (glejte poglavje 4. 3).
Ritonavir: the AUC and Cmin of amprenavir were increased by 64% and 508% respectively and the Cmax decreased by 30% when ritonavir (100 mg twice daily) was coadministered with amprenavir capsules (600 mg twice daily) compared to values achieved after 1200 mg twice daily doses of amprenavir capsules.
Cmax amprenavirja se je znižala za 30%.
In the same study, the AUC, Cmax, and Cmin of amprenavir were increased 72%, 12%, and 483%, respectively, when compared to values after standard doses of amprenavir (1200 mg twice daily).
27 amprenavirja (1200 mg dvakrat dnevno), AUC, Cmax in Cmin amprenavirja zvečale, in sicer AUC za 72%, Cmax za 12% in Cmin za 483%.
The amprenavir plasma Cmin values achieved with the combination of amprenavir (600 mg twice daily) in combination with Kaletra (400 mg lopinavir + 100 mg ritonavir twice daily) are approximately 40- 50% lower than when amprenavir (600 mg twice daily) is given in combination with ritonavir 100 mg
Dosežene vrednosti Cmin amprenavirja v plazmi po dajanju amprenavirja (600 mg dvakrat dnevno) v kombinaciji z zdravilom Kaletra (400 mg lopinavirja + 100 mg ritonavirja dvakrat dnevno) so bile približno za 40– 50% nižje kot po dajanju kombinacije amprenavir (600 mg dvakrat dnevno) plus ritonavir (100 mg dvakrat dnevno).
Abacavir: the AUC, Cmin, and Cmax of abacavir were unaltered when given with amprenavir.
AUC, Cmin in Cmax amprenavirja so se zvečale:
The AUC, Cmin, and Cmax of amprenavir were increased by 29%, 27%, and 47%, respectively.
AUC za 29%, Cmin za 27% in Cmax za 47%.
Efavirenz: efavirenz has been seen to decrease the Cmax, AUC, and Cmin, ss of amprenavir by approximately 40% in adults.
Pri odraslih je bilo opaženo, da efavirenz zmanjša Cmax, AUC in Cmin, ss amprenavirja za približno 40%.
No dose recommendations can be given for the co-administration of amprenavir and low dose ritonavir with delavirdine.
28 Za sočasno uporabo amprenavirja, nizkih odmerkov ritonavirja in delavirdina ne moremo podati priporočenih odmerkov.
28 close clinical and virological monitoring should be performed since it is difficult to predict the effect of the combination of amprenavir and ritonavir on delavirdine.
Ob sočasni uporabi teh zdravil svetujemo previdnost in temeljito klinično in virološko nadziranje, saj je učinek kombinacije amprenavirja in ritonavirja na delavirdin težko napovedati.
Antibiotics/ antifungals
Antibiotiki/ antimikotiki
The AUC, Cmin and Cmax of amprenavir were increased by 18%, 39%, and 15% respectively.
AUC, Cmin in Cmax amprenavirja so se zvečale, in sicer AUC za 18%, Cmin za 39% in Cmax za 15%.
Ketoconazole / Itraconazole: the AUC and Cmax of ketoconazole were increased by 44% and 19% respectively when given with amprenavir alone.
Pri sočasni uporabi ketokonazola in amprenavirja sta se AUC in Cmax ketokonazola zvišali, in sicer AUC za 44%, Cmax pa za 19%.
29 Erectile dysfunction agents: based on data for other protease inhibitors caution should be used when prescribing PDE5 inhibitors (e. g. sildenafil and vardenafil) to patients receiving Agenerase.
29 nimodipin, nisoldipin in verapamil, kar ima lahko za posledico okrepljen učinek in toksičnost teh zdravil.
Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules bid were co-administered with 50 µg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82-89%).
Pri zdravih osebah, ki so med klinično študijo 7 dni sočasno prejemale ritonavir v obliki 100 mg kapsul dvakrat dnevno in flutikazonpropionat v odmerku 50 µg intranazalno (4- krat dnevno) so ugotovili, da so se vrednosti flutikazonpropionata v plazmi znatno povečale, intrinzične vrednosti kortizola pa zmanjšale za približno 86% (90% interval zaupanja; 82- 89%).
30 As compared to a non-matched historical control group, co-administration of methadone and amprenavir resulted in a 30%, 27% and 25% decrease in serum amprenavir AUC, Cmax and Cmin respectively.
AUC za 30%, Cmax za 27% in Cmin za 25%.
Oral anticoagulants: a reinforced monitoring of the International Normalised Ratio is recommended in case of administration of Agenerase with warfarin or other oral anticoagulants, due to a possible decrease or increase of their antithrombotic effect (see section 4.4).
Priporočamo poostreno nadziranje internacionalnega normaliziranega razmerja, če se zdravilo Agenerase uporablja skupaj z varfarinom ali drugimi peroralnimi antitrombotiki, zaradi možnega zmanjšanja ali povečanja njihovega antitrombotičnega učinka (glejte poglavje 4. 4).
4.7 Effects on ability to drive and use machines
31 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Adverse events considered associated with the use of Agenerase are gastro-intestinal symptoms, rash and oral/ peri-oral
Neželeni učinki, za katere se predpostavlja, da so povezani z uporabo zdravila Agenerase, so gastrointestinalni simptomi, eksantem in oralna/ perioralna parestezija.
In study PROAB3006, seven cases (3%) were reported in 245 NRTI-experienced subjects treated with amprenavir and in 27 (11%) of 241 subjects treated with indinavir, in combination with various NRTIs for a median duration of 56 weeks (p < 0.001).
V študiji PROAB3006 so poročali o sedmih primerih (3%) pri 245 predhodno z NRTI- ji že zdravljenih osebah, ki so se zdravile z amprenavirjem, in o 27 primerih (11%) pri 241 osebah, ki so se v povprečju
32 Gastrointestinal disorders
Bolezni prebavil
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
33 Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART - "combination antiretroviral therapy") nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment provided as necessary.
V primeru prevelikega odmerjanja je potrebno bolnika nadzirati glede znakov toksičnosti (glejte poglavje 4. 8) in po potrebi zagotoviti običajno podporno terapijo.
Pharmacotherapeutic group; protease inhibitor; ATC Code:
Zaviralci proteaz, Oznaka ATC:
HIV-1 isolates with decreased susceptibility to amprenavir have been selected during in vitro serial passage experiments Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47V or I54M mutations.
Zmanjšana občutljivot za amprenavir je bila povezana z virusom pri katerem so se pojavile mutacije I50V, I84V, V32I+I47V ali I54M.
34 b) PI-experienced patients
b) Bolniki, ki so se že zdravili z zaviralci proteaz
In the studies of PI-experienced patients, PRO30017 (amprenavir 600 mg / ritonavir 100 mg twice daily in sub-study A and B with 80 and 37 patients respectively), the following mutations emerged in patients with virological failure:
V študijah bolnikov, ki so že bili zdravljeni z zaviralci proteaz, PRO30017 (amprenavir 600 mg / ritonavir 100 mg dvakrat na dan in podštudijah A in B, v katere je bilo vključenih 80 oziroma 37 bolnikov), so se pri bolnikih z virusnim neodzivom pojavile naslednje mutacije:
L10F/ I, L24I, V32I, L33F, M36I, M46I/ L, I47V, I50V, I54L/ M/ S, A71I/ T/ V, G73S, V82A, I84V, and L90M.
L10F/ I, L24I, V32I, L33F, M36I, M46I/ L, I47V, I50V, I54L/ M/ S, A71I/ T/ V, G73/ S, V82A, I84Vin L90M.
Cross-Resistance
35 Navzkrižna rezistenca
Based on data from twenty-five antiretroviral naïve patients failing a fosamprenavir containing regimen (one of whom showed Baseline resistance to lopinavir and saquinavir and another to tipranavir) the resistance pathways associated with amprenavir produce limited cross-resistance to atazanavir/ ritonavir (three of 25 isolates), darunavir/ ritonavir (four of 25 isolates), indinavir/ ritonavir (one of 25 isolates), lopinavir/ ritonavir (three of 24 isolates), saquinavir (three of 24 isolates) and tipranavir/ ritonavir (four of 24 isolates)..
Na osnovi podatkov, pridobljenih pri petindvajsetih bolnikih, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili in pri katerih je bilo zdravljenje z režimom, ki je vključeval fosamprenavir neuspešno (pri enem od njih je bila v izhodišču prisotna odpornost na lopinavir in sakvinavir, pri enem pa na tipranavir), mehanizem rezistence, povezan z amprenavirjem, povzroča omejeno navzkrižno rezistenco na atazanavir/ ritonavir (trije od 25 izolatov), darunavir/ ritonavir (štirje od 25 izolatov), indinavir/ ritonavir (eden od 25 izolatov), lopinavir/ ritonavir (trije od 24 izolatov), sakvinavir (trije od 24 izolatov) in tipranavir/ ritonavir (štirje od 24 izolatov).
Conversely amprenavir retains activity against some isolates with resistance to other PIs and this retained activity would depend on the number and type of protease resistance mutations present in the isolates.
Ta ohranjena učinkovitost je odvisna od števila in tipa rezistenčnih mutacij proteaze izolatov.
35 The number of key PI-resistance mutations increases markedly the longer a failing PI-containing regimen is continued.
Število ključnih mutacij, povezanih z rezistenco na zaviralce proteaz, znatno narašča z daljšanjem trajanja neuspešnega zdravljenja s kombinacijami, ki vključujejo zaviralce proteaz.
Results at week 16
36 Rezultati v 16. tednu
primary mutations 1 Prior number of NRTIs
≥3 Srednje število
1.0
1, 0 (razpon 0- 2)
(range 0-2)
1, 0 (razpon 0- 2)
At Week 48, approximately 25% of those enrolled had plasma HIV-1 RNA < 10,000 copies/ ml and 9% < 400 copies/ ml with a median change from baseline in CD4+ cells of 26 cells/ mm3 (n=74).
Srednja sprememba števila celic CD4+ od izhodišča je bila 26 celic/ mm3 (n = 74).
Based on these data, careful consideration should be given to the expected benefit of unboosted Agenerase when optimising therapy for PI experienced children.
37 Pri otrocih, ki so se že zdravili s PI- ji, je na osnovi teh podatkov pri izbiranju najboljše oblike zdravljenja treba skrbno razmisliti o koristi uporabe zdravila Agenerase brez okrepitve.
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.
Concentrations of AAG have
Pokazalo se je, da se koncentracije AAG med protiretrovirusnim zdravljenjem zmanjšujejo.
While absolute free active substance concentrations remain constant, the percent of free active substance will fluctuate directly with total active substance concentrations at steady-state go from Cmax, ss to Cmin, ss over the course of the dosing interval.
Medtem ko absolutne koncentracije proste učinkovine ostanejo konstantne, se tekom odmernega intervala odstotek proste učinkovine skladno s celokupno koncentracijo aktivne učinkovine v stanju dinamičnega ravnovesja spreminja od Cmax, ss do Cmin, ss.
Therefore medicinal products that are inducers, inhibitors or substrates of CYP3A4 must be used with caution when administered concurrently with Agenerase (see sections 4.3, 4.4 and 4.5).
Amprenavir je substrat za CYP3A4 in ga zavira, zato je potrebna previdnost pri sočasni uporabi zdravil, ki so induktorji, zaviralci ali substrati CYP3A4, in zdravila Agenerase (glejte poglavja 4. 3, 4. 4, in 4. 5).
The primary route of elimination of amprenavir is via hepatic metabolism with less than 3% excreted unchanged in the urine.
Poglavitna pot izločanja amprenavirja iz telesa poteka preko presnove v jetrih, pri čemer se ga manj kot 3% izloči v nespremenjeni obliki z urinom.
The metabolites and unchanged amprenavir account for approximately 14% of the administered amprenavir dose in the urine, and approximately 75% in the faeces.
Približno 14% amprenavirja se izloči v obliki presnovkov ali nespremenjeni obliki z urinom, približno 75% pa z blatom.
In long-term carcinogenicity studies with amprenavir in mice and rats, there were benign hepatocellular adenomas in males at exposure levels equivalent to 2.0-fold (mice) or 3.8-fold (rats) those in humans given 1200 mg twice daily of amprenavir alone.
V dolgotrajnih študijah kancerogenega potenciala amprenavirja na miših in podganah je pri samcih ob izpostavi odmerkom, ekvivalentnim 2, 0- kratnim (miši) ali 3, 8- kratnim (podgane) odmerkom, ki se dajejo človeku (1200 mg amprenavirja samega dvakrat dnevno), prihajalo do benignih hepatocelularnih adenomov.
38 A higher incidence of hepatocellular carcinoma was seen in all amprenavir male mouse treatment groups.
Pri vseh skupinah mišjih samcev, ki so bile izpostavljene amprenavirju, je bila opažena višja pojavnost hepatocelularnih karcinomov.
These results imply that young animals lack fully developed metabolic pathways enabling them to excrete amprenavir or some critical components of the formulation (e. g. propylene glycol, PEG400).
Dobljeni rezultati kažejo, da se pri mladičih, katerih presnovne poti še niso docela razvite, amprenavir ali nekatere druge sestavine zdravila (npr. propilenglikol, PEG 400) niso mogli izločati.
39 6.3 Shelf life
6. 3 Rok uporabnosti
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 0NN Velika Britanija
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Agenerase 15 mg/ ml oral solution.
Agenerase 15 mg/ ml peroralna raztopina
Agenerase oral solution contains 15 mg/ ml of amprenavir.
Peroralna raztopina Agenerase vsebuje 15 mg/ ml amprenavirja.
Agenerase oral solution, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years.
Peroralna raztopina Agenerase je, v kombinaciji z drugimi protiretrovirusnimi zdravili, indicirana za zdravljenje odraslih in otrok, starejših od 4 let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1) in so predhodno že bili zdravljeni z zaviralcem proteaz (PI- jem).
The benefit of Agenerase oral solution boosted with ritonavir has not been demonstrated either in PI naïve patients or in PI experienced patients.
Korist uporabe peroralne raztopine Agenerase, okrepljene z ritonavirjem, ni bila dokazana niti pri bolnikih, ki se predhodno še niso zdravili s PI- ji, niti bolnikih, ki so se že zdravili s PI- ji.
Amprenavir is 14% less bioavailable from the Agenerase oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis (see section 5.2).
Biološka uporabnost amprenavirja v peroralni raztopini je za 14% manjša kot v kapsulah, zato kapsule Agenerase in peroralna raztopina Agenerase niso zamenljive v enakih miligramskih odmerkih (glejte poglavje 5. 2).
Patients should discontinue Agenerase oral solution as soon as they are able to swallow the capsule formulation (see section 4.4).
Bolniki morajo opustiti jemanje peroralne raztopine Agenerase takoj, ko so zmožni pogoltniti zdravilo Agenerase v obliki kapsul (glejte poglavje 4. 4).
Patients of 4 years and older unable to swallow Agenerase capsules: the recommended dose of Agenerase oral solution is 17 mg (1.1 ml)/ kg three times a day, in combination with other antiretroviral agents, without exceeding a total daily dose of 2800 mg (see section 5.1).
Priporočen odmerek peroralne raztopine Agenerase je 17 mg (1, 1 ml) / kg trikrat dnevno v kombinaciji z drugimi protiretrovirusnimi zdravili, skupni dnevni odmerek pa ne sme presegati 2800 mg (glejte poglavje 5. 1).
The pharmacokinetic interactions between amprenavir and low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
42 Farmakokinetične interakcije med amprenavirjem in nizkimi odmerki ritonavirja ali drugimi zaviralci proteaz pri otrocih še niso bile ovrednotene.
41 Children less than 4 years of age:
Otroci, mlajši od 4 let:
(see sections 4.3 and 5.3).
Peroralna raztopina Agenerase je kontraindicirana pri otrocih, mlajših od 4 let (glejte poglavji 4. 3 in 5. 3).
(see section 5.2).
Farmakokinetične lastnosti, učinkovitost in varnost amprenavirja pri bolnikih, starejših od 65 let, niso bile raziskane (glejte poglavje 5. 2).
Renal impairment: although no dose adjustment is considered necessary for amprenavir, Agenerase oral solution is contraindicated in patients with renal failure (see section 4.3).
Kljub temu da odmerka amprenavirja ni potrebno prilagajati, je peroralna raztopina Agenerase kontraindicirana pri bolnikih z odpovedjo ledvic (glejte poglavje 4. 3).
Hepatic impairment:
Oslabljeno delovanje jeter:
Agenerase oral solution is contraindicated in patients with hepatic impairment or failure (see section 4.3) (see Summary of Product Characteristics of Agenerase Capsules for prescribing information)
4. 3 Kontraindikacije
Agenerase oral solution is also contraindicated in patients treated with disulfiram or other medicinal products that reduce alcohol metabolism (e. g. metronidazole) and preparations that contain alcohol (e. g. ritonavir oral solution) or additional propylene glycol (see section 4.4and 5.1).
Ravno tako je peroralna raztopina Agenerase kontraindicirana pri bolnikih, ki se zdravijo z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali pripravki z dodatnim propilenglikolom (glejte poglavji 4. 4 in 5. 1).
Co-administration may result in competitive inhibition of the metabolism of these medicinal products and create the potential for serious and/ or life-threatening adverse events such as cardiac arrhythmia (e. g. amiodarone, bepridil, quinidine, terfenadine, astemizole, cisapride, pimozide), respiratory depression and / or prolonged sedation (e. g. oral triazolam and oral midazolam (for caution on parenterally administred midazolam, see section 4.5)) or peripheral vasospasm or ischaemia and ischaemia of other tissues, including cerebral or myocardial ischaemia (e. g. ergot derivatives).
Sočasna uporaba ima lahko za posledico kompetitivno inhibicijo presnavljanja teh zdravil in izzove možnost hujših in/ ali življenjsko usodnih neželenih učinkov, kot so: aritmija (npr. amiodaron, bepridil, kinidin, terfenadin, astemizol, cisaprid, pimozid), depresija dihanja in/ ali podaljšana sedacija (npr. peroralna uporaba triazolama ali midazolama (glede previdnostnih ukrepov ob parenteralni uporabi midazolama glejte poglavje 4. 5)) ali periferni vazospazem ali ishemija in ishemija drugih tkiv, vključno s cerebralno ali miokardno ishemijo (npr. derivati ergot alkaloidov).
Liver Disease:
43 Jetrno obolenje:
The principal route of metabolism of amprenavir and the propylene glycol excipient is via the liver, Agenerase oral solution is contraindicated in patients with hepatic impairment or failure (see section 4.3).
Peroralna raztopina Agenerase je kontraindicirana pri bolnikih z oslabljenim delovanjem ali odpovedjo jeter (glejte poglavje 4. 3).
42 Patients taking the oral solution of Agenerase, particularly those with renal impairment or those with decreased ability to metabolise propylene glycol (e. g. those of Asian origin), should be monitored for adverse reactions potentially related to the high propylene glycol content (550 mg/ ml), such as seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis.
Pri bolnikih, ki jemljejo peroralno raztopino Agenerase, še posebno pri tistih z oslabljenim delovanjem ledvic ali zmanjšano zmožnostjo presnove propilenglikola (npr. azijsko poreklo), je potrebno, zaradi velike vsebnosti propilenglikola (550 mg/ ml) nadzirati možne, s tem povezane neželene učinke, kot so: epileptični napadi, stupor, tahikardija, hiperosmolarnost, laktacidoza, toksičnost za ledvice ali hemoliza.
For patients with renal failure, hepatic impairment or failure, children and pregnant women, see section 4.3.
Glede bolnikov z odpovedjo ledvic, bolnikov z oslabljenim delovanjem ali odpovedjo jeter, otrok in nosečnic glejte poglavje 4. 3.
The concomitant administration of Agenerase oral solution with disulfiram or other medicinal products that reduce alcohol metabolism (e. g. metronidazole), or preparations that contain alcohol (e. g. ritonavir oral solution) or additional propylene glycol is contraindicated (see sections 4.3and 4.5).
Uporaba peroralne raztopine Agenerase sočasno z disulfiramom ali drugimi zdravili, ki zmanjšujejo presnovo alkohola (npr. metronidazol), s pripravki z alkoholom (npr. peroralna raztopina ritonavirja) ali s pripravki z dodatnim propilenglikolom je kontraindicirana (glejte poglavji 4. 3 in 4. 5).
Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Agenerase (see section 4.5).
Priporočamo nadziranje terapevtskih koncentracij zdravil za zaviranje imunske odzivnosti (ciklosporin, takrolimus, rapamicin), če se jih uporablja skupaj z zdravilom Agenerase (glejte poglavje 4. 5).
A reduction of rifabutin dosage of at least 50% is recommended when administered with Agenerase (see section 4.5).
Če se rifabutin daje sočasno z zdravilom Agenerase priporočamo, da se odmerek rifabutina zmanjša vsaj za 50% (glejte poglavje 4. 5).
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
No recommendations can currently be made regarding adjustment of amprenavir dose when amprenavir is co-administered with methadone.
Priporočil glede prilagajanja odmerka amprenavirja, če se le- ta uporablja sočasno z metadonom, ne moremo podati.
43 Agenerase oral solution contains vitamin E (46 IU/ ml), therefore additional vitamin E supplementation is not recommended.
Peroralna raztopina Agenerase vsebuje vitamin E (46 i. e. / ml), zato ni priporočljiva dodatna uporaba vitamina E.
This must be considered when prescribing to patients with reduced kidney function or patients on a controlled potassium diet.
Peroralna raztopina Agenerase vsebuje 1 mg kalija na ml, kar je treba upoštevati pri bolnikih, ki imajo oslabljeno delovanje ledvic ali bolnikih, ki so na dieti z znižanim kalijem.
This must be taken into consideration when prescribing to patients on a controlled sodium diet.
Peroralna raztopina Agenerase vsebuje tudi 4 mg natrija na ml, kar je treba upoštevati pri bolnikih, ki so na dieti z znižanim natrijem.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Pozornost je potrebno posvetiti tudi kontroli serumskih lipidov na tešče in kontroli glukoze v krvi.
Immune Reactivation Syndrome
45 Sindrom imunske reaktivacije
44 Osteonecrosis
Osteonekroza
Rifampicin Rifampicin is a strong CYP3A4 inducer and has been shown to cause an 82% decrease in amprenavir AUC, which can result in virological failure and resistance development.
Posledica tega je lahko upad protivirusnega delovanja in razvoj rezistence.
Antiretroviral agents
46 Protiretrovirusna zdravila
• Protease inhibitors (PIs)
• Zaviralci proteaz (PI- ji):
45 Saquinavir: the AUC, Cmin and Cmax of saquinavir were decreased by 19% and 48% and increased by 21%, respectively, when given with amprenavir.
Ob sočasnem dajanju z amprenavirjem sta se AUC in Cmin sakvinavirja zmanjšali, in sicer AUC za 19%, Cmin pa za 48%; Cmax sakvinavirja se je zvišala za 21%.