natgillin/translations-raw huggingface dataset:
The current (July 2006) ANRS AC-11 algorithm for fosamprenavir / ritonavir defines resistance as the presence of the mutations V32I+I47A/V, or I50V, or at least four mutations among: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V and L90M and is associated with increased phenotypic resistance to fosamprenavir with ritonavir as well as reduced likelihood of virological response (resistance).
Trenutni (julij 2006) ANRS AC-11 algoritem za fosamprenavir / ritonavir opredeljuje rezistenco kot prisotnost mutacij V32I+I47A/V ali I50V ali vsaj štirih mutacij izmed: L10F/I/V, L33F, M36I, I54A/L/M/S/T/V, I62V, V82A/C/F/G, I84V in L90M ter je povezan tako s povečano fenotipsko odpornostjo na fosamprenavir z ritonavirjem kot tudi z zmanjšano verjetnostjo virusnega odziva (rezistence).
These active substances include flecainide and propafenone.
Takšni učinkovini sta tudi flekainid in propafenon.
A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Domneva se, da gre za povezavo med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in nukleozidnimi in nukleotidnimi zaviralci reverzne transkriptaze.
Antiretroviral agents
Protiretrovirusna zdravila
• Nucleoside analogue reverse transcriptase inhibitors (NRTIs):
• Zaviralci nukleotidne in nukleozidne reverzne transkriptaze (NRTI-ji):
In the paediatric studies APV20003 and APV29005, 67 PI-experienced patients were treated with fosamprenavir / ritonavir and of 22 virological failure isolates genotyped, nine patients were found with treatment-emergent protease mutations.
V študijah APV20003 in APV29005, ki so jih izvedli pri otrocih, je 67 bolnikov, ki se se predhodno že zdravili z zaviralci proteaz, prejemalo fosamprenavir / ritonavir.
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 primary route of metabolism is via the cytochrome P450 CYP3A4 enzyme.
Primarna presnovna pot poteka preko encima citokrom P450 CYP3A4.
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).
This leaflet was last approved on
Navodilo je bilo odobreno:
Metabolism: amprenavir is primarily metabolised by the liver with less than 3 % excreted unchanged in the urine.
Presnova: Amprenavir se primarno presnavlja v jetrih, manj kot 3 % se ga v nespremenjeni obliki izloči z urinom.
Agenerase capsules contain vitamin E (36 IU/50 mg capsule), therefore additional vitamin E supplementation is not recommended.
Kapsule Agenerase vsebujejo vitamin E (36 i.e./50 mg kapsulo), zato ni priporočljiva dodatna uporaba vitamina E.
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.
Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47V or I54M mutations.
Zmanjšana občutljivost za amprenavir je bila povezana z virusom, pri katerem je prišlo do mutacij I50V ali I84V ali V32I+I47V ali I54M.
No drug interaction study has been performed for the co-administration of Agenerase with benzodiazepines.
Raziskave medsebojnega delovanja ob sočasni uporabi zdravila Agenerase in benzodiazepinov niso bile izvedene.
Amprenavir and ritonavir are primarily metabolised in the liver by CYP3A4.
Amprenavir in ritonavir se primarno presnavljata v jetrih s CYP3A4.
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).
Oslabljeno delovanje ledvic: Kljub temu da odmerka amprenavirja ni potrebno prilagajati, je peroralna raztopina Agenerase kontraindicirana pri bolnikih z odpovedjo ledvic (glejte poglavje 4.3).
HMG-CoA reductase inhibitors: HMG-CoA reductase inhibitors which are highly dependent on CYP3A4 for metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with Agenerase.
Zaviralci HMG-CoA reduktaze: Za zaviralce HMG-CoA reduktaze, kot sta lovastatin in simvastatin, ki so pri presnovi zelo odvisni od CYP3A4, se ob sočasni uporabi z zdravilom Agenerase pričakuje znatno povišanje njihovih plazemskih koncentracij.
(Note: Agenerase is not approved in ART-naive or PI-naive patients).
(Opozorilo: Zdravilo Agenerase ni odobreno za zdravljenje bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz).
Clarithromycin: the AUC and Cmin of clarithromycin were unaltered and the Cmax decreased by 10 % when given with amprenavir.
Klaritromicin: Ob sočasni uporabi z amprenavirjem sta AUC in Cmin klaritromicina ostali nespremenjeni, Cmax klaritromicina pa se je znižala za 10 %.
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.
Do not use Agenerase after the expiry date which is stated on the carton.
Zdravila Agenerase ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici.
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).
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).
The Cmin of ethinyl estradiol was increased by 32%, whilst the AUC and Cmin of norethindrone were increased by 18% and 45% respectively.
Cmin etinilestradiola se je zvišala za 32 %, medtem ko sta se AUC in Cmin noretindrona zvečali: AUC za 18 % in Cmin za 45 %.
Delavirdine: the AUC, Cmax and Cmin of delavirdine were decreased by 61%, 47% and 88% respectively when given with amprenavir.
Delavirdin: Ob sočasnem dajanju z amprenavirjem so se AUC, Cmax in Cmin delavirdina zmanjšale, in sicer AUC za 61 %, Cmax za 47 % in Cmin za 88 %.
When ritonavir is co-administered further dose reduction may be necessary (see section 4.5).
Pri sočasnem dajanju ritonavirja bo morda odmerek rifabutina potrebno še nadalje zmanjšati (glejte poglavje 4.5).
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 4050% lower than when amprenavir (600 mg twice daily) is given in combination with ritonavir 100 mg twice daily.
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).
Agenerase oral solution should not be used during pregnancy due to the potential risk of toxicity to the foetus from the propylene glycol content (see section 4.3).
Peroralna raztopina Agenerase se med nosečnostjo zaradi možne, s propilenglikolom povezane toksičnosti za plod ne sme uporabljati (glejte poglavje 4.3).
Severe or life-threatening skin reactions have also occurred in patients treated with amprenavir (see section 4.4).
Pri bolnikih, ki so se zdravili z amprenavirjem, pa so se pojavile tudi hude ali življenjsko usodne kožne reakcije (glejte poglavje 4.4).
Propylene glycol, macrogol 400 (PEG 400), d-alpha tocopheryl polyethylene glycol 1000 succinate, acesulfame potassium, saccharin sodium, sodium chloride, artificial grape bubblegum flavour, natural peppermint flavour, menthol, citric acid, anhydrous, sodium citrate dihydrate, purified water.
Propilenglikol, makrogol 400 (PEG 400), D-α-tokoferilpolietilenglikol 1000 sukcinat, kalijev acesulfamat, saharin natrijeva sol, natrijev klorid, umetna aroma žvečilnega gumija z okusom grozdja, naravna aroma poprove mete, mentol, brezvodna citronska kislina, natrijev citrat dihidrat, prečiščena voda.
White High Density Polyethylene (HDPE) bottles containing 240 ml of oral solution.
Bele plastenke iz polietilena visoke gostote (HDPE), ki vsebujejo 240 ml peroralne raztopine.
Those of at least 13 years of age and weighing at least 50 kg received 1200 mg Agenerase twice daily.
Otroci, stari najmanj 13 let in s telesno maso najmanj 50 kg, so prejemali zdravilo Agenerase v odmerku 1.200 mg dvakrat na dan.
It is a clear, pale yellow to yellow solution with grape, bubblegum and peppermint flavouring.
Je bistra, bledo rumena do rumena raztopina z aromo grozdja, žvečilnega gumija in poprove mete.
Capsule contents: d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (PEG 400), propylene glycol.
Vsebina kapsule: D-α-tokoferilpolietilenglikol 1000 sukcinat (TPGS), makrogol 400 (PEG 400), propilenglikol.
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).
Bolniki stari 4 leta in starejši, ki ne zmorejo pogoltniti kapsul Agenerase: 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).
Three of 14 isolates had protease resistance mutations.
Rezistenčna mutacija proteaze je bila prisotna pri 3 od 14 izolatov.
When methadone is co-administered with amprenavir, patients should be monitored for opiate abstinence syndrome, in particular if low-dose ritonavir is also given.
Če se metadon uporablja sočasno z amprenavirjem, je potrebno bolnike nadzirati glede opiatnega abstinenčnega sindroma, še posebno ob sočasni uporabi nizkih odmerkov ritonavirja.
Rare side effects (these can affect 1 in 1,000 patients treated)
Redki neželeni učinki (ki se lahko pojavijo pri 1 od 1.000 zdravljenih bolnikov)
The AUC and the Cmax of amprenavir were unaltered.
AUC in Cmax amprenavirja sta ostali nespremenjeni.
The combination of rifampicin and Agenerase with concomitant low-dose ritonavir is contraindicated (see section 4.3).
Kombinacija rifampicina in zdravila Agenerase skupaj z nizkim odmerkom ritonavirja je kontraindicirana (glejte poglavje 4.3).
Because Agenerase capsules contain vitamin E, you should not take additional vitamin E supplements.
Ker kapsule Agenerase vsebujejo vitamin E, le-tega ne jemljite še dodatno.
These active substances include flecainide and propafenone (see section 4.3).
Takšni učinkovini sta tudi flekainid in propafenon (glejte poglavje 4.3).
The oral solution is clear, pale yellow to yellow with grape, bubblegum and peppermint flavouring.
Peroralna raztopina je bistra, bledo rumena do rumena z aromo grozdja, žvečilnega gumija in poprove mete.
Because of the potential risk of toxicity from the large amount of the excipient propylene glycol, Agenerase oral solution is contraindicated in infants and children below the age of 4 years, pregnant women, patients with hepatic impairment or failure and patients with renal failure.
Zaradi visoke vsebnosti propilenglikola kot pomožne snovi in s tem povezane možne toksičnosti, je peroralna raztopina Agenerase kontraindicirana pri dojenčkih, otrocih mlajših od 4 let, nosečnicah, bolnikih z oslabljenim delovanjem ali odpovedjo jeter in pri bolnikih z odpovedjo ledvic.
The AUC increased nearly three-fold in patients with moderate impairment and four fold in patients with severe hepatic impairment.
Pri bolnikih z zmerno obliko oslabljenega delovanja se je AUC povečala skoraj za trikrat, pri tistih s hudo obliko pa za štirikrat.
Important information about ingredients of Agenerase oral solution The oral solution contains propylene glycol, which can cause adverse effects in high doses.
Pomembne informacije o nekaterih sestavinah kapsul Agenerase Peroralna raztopina vsebuje propilenglikol, ki lahko pri velikih odmerkih povzroči neželene učinke.
EXPIRY DATE EXP {MM/YYYY}
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {MM/LLLL}
In clinical studies, the safety and efficacy of amprenavir have not yet been established in children below four years of age.
Varnost in učinkovitost amprenavirja pri otrocih, mlajših od 4 let, še nista bili dokazani s kliničnimi študijami.
Other possible effects
Ostali možni neželeni učinki
This must be considered when prescribing to patients with reduced kidney function or patients on a controlled potassium diet.
Pozornost je potrebna pri bolnikih, ki imajo oslabljeno delovanje ledvic in bolnikih, ki so na diati z nižanjem kalija.
• Increases in the blood of a substance called bilirubin
• Povečane vrednosti bilirubina v krvi.
Medicinal products - interactions
Interakcije z zdravili
The Cmax, AUC and Cmin of amprenavir were unchanged.
Vrednosti Cmax, AUC in Cmin amprenavirja so ostale nespremenjene.
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.
Less than 3 % of the therapeutic dose of amprenavir is excreted unchanged in the urine.
Z urinom se v nespremenjeni obliki izloči manj kot 3 % terapevtskega odmerka amprenavirja.
- The use of Agenerase together with ritonavir has not been studied in patients with liver disease.
- Uporaba zdravila Agenerase skupaj z ritonavirjem pri bolnikih z jetrno boleznijo ni bila raziskana.
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.
Primerjava z neenakovredno kontrolno historično skupino pokaže, da je sočasna uporaba metadona in amprenavirja imela za posledico zmanjšanje AUC, Cmax in Cmin amprenavirja v serumu: AUC za 30 %, Cmax za 27 % in Cmin za 25 %.
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.
Coadministration of fosamprenavir 700 mg with ritonavir 100 mg twice daily and ketoconazole 200 mg once daily increased plasma ketoconazole Cmax by 25 % and increased AUC(0-τ) to values 2.69-fold those observed on administration of ketoconazole 200 mg once daily without concurrent fosamprenavir with ritonavir.
Pri sočasni uporabi fosamprenavirja v odmerku 700 mg skupaj z ritonavirjem v odmerku 100 mg dvakrat na dan in ketokonazola v odmerku 200 mg enkrat na dan se je plazemska Cmax ketokonazola zvišala za 25 %, vrednosti AUC(0-τ) ketokonazola pa so bile za 2,69-krat višje kot pri uporabi ketokonazola v odmerku 200 mg enkrat na dan brez sočasne uporabe fosamprenavirja z ritonavirjem.
There is no data on the efficacy of boosted Agenerase in children.
O uporabi zdravila Agenerase z okrepitvijo pri otrocih ni podatkov.
Sixteen of 434 ART-naïve patients who received fosamprenavir 700mg/ritonavir 100mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
V študiji ESS100732 se je pri zdravljenju s fosamprenavirjem 700 mg/ritonavirjem 100 mg dvakrat na dan v 48. tednu virusni neodziv pojavil pri 16 od 434 bolnikov, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, pri čemer so določili genotip 14 izolatov.
When ritonavir is co-administered an increase in clarithromycin concentrations may occur.
Sočasna uporaba ritonavirja lahko vodi do zvišanih koncentracij klaritromicina.
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, PEG 400).
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.
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.
Hyperbilirubinaemia
hiperbilirubinemija
It is therefore recommended that mothers being treated with Agenerase do not breast-feed their infants.
V primeru zdravljenja z zdravilom Agenerase je priporočljivo, da matere otrok ne dojijo.
Herbal preparations containing St John's wort should therefore not be combined with Agenerase.
Rastlinski pripravki iz šentjanževke se torej ne smejo kombinirati z zdravilom Agenerase.
Agenerase is administered orally and can be taken with or without food.
Peroralna raztopina Agenerase se uporablja peroralno in se sme jemati s hrano ali brez nje.
Therefore, interactions with amprenavir due to protein binding displacement are highly unlikely.
Zato je zelo malo verjetno, da bi zaradi izpodrivanja z vezavnih mest na proteinih pri jemanju amprenavirja prišlo do medsebojnega delovanja z drugimi zdravili.
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking amprenavir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Zeliščni pripravki s šentjanževko (Hypericum perforatum) se zaradi nevarnosti znižanja plazemskih koncentracij in manjše klinične učinkovitosti amprenavirja ne smejo uporabljati sočasno z amprenavirjem (glejte poglavje 4.5).
Renal impairment: no dose adjustment is considered necessary in patients with renal impairment (see section 5.2).
Oslabljeno delovanje ledvic: Pri bolnikih z oslabljenim delovanjem ledvic odmerka ni potrebno prilagoditi (glejte poglavje 5.2).
Should this happen to you, seek immediate advice from your doctor.
V takšnem primeru se nemudoma posvetujte s svojim zdravnikom.
Amprenavir is 14 % less bioavailable from the oral solution than from the capsules; therefore, Agenerase capsules and Agenerase oral solution are not interchangeable on a milligram per milligram basis.
Biološka uporabnost amprenavirja v peroralni raztopini je za 14 % manjša kot v kapsulah, zato kapsule Agenerase in peroralna raztopina Agenerase nista zamenljivi v enakih miligramskih odmerkih.
The benefit of Agenerase oral solution boosted with ritonavir has not been demonstrated either in protease inhibitor naïve patients or protease inhibitor experienced patients.
Korist uporabe peroralne raztopine Agenerase, okrepljene z ritonavirjem, ni bila dokazana niti pri bolnikih, ki se predhodno še niso zdravili z zaviralci proteaz, niti bolnikih, ki so se že zdravili z zaviralci proteaz.
To derive the full benefit of Agenerase, it is very important that you take the full daily dose prescribed by your doctor.
Zelo pomembno je, da vzamete celoten dnevni odmerek, ki vam ga je predpisal zdravnik, saj se le tako lahko doseže popolna korist zdravila Agenerase.
Genotypic interpretation systems may be used to estimate the activity of amprenavir / ritonavir or fosamprenavir / ritonavir in subjects with PI-resistant isolates.
Za ocenjevanje delovanja amprenavirja / ritonavirja ali fosamprenavirja / ritonavirja pri osebah z izolati, odpornimi na zaviralce proteaz, se lahko uporabijo genotipski interpretacijski sistemi.
Very common side effects (these can affect more than 10 in 100 patients treated)
Zelo pogosti neželeni učinki (ki se lahko pojavijo pri več kot 10 od 100 zdravljenih bolnikov)
CYP3A4 substrates with narrow therapeutic index Agenerase must not be administered concurrently with medicinal products with narrow therapeutic windows containing active substances that are substrates of cytochrome P450 3A4 (CYP3A4).
Substrati za CYP3A4 z ozkim terapevtskim indeksom Zdravilo Agenerase se ne sme dajati sočasno z zdravili z ozko terapevtsko širino, ki vsebujejo učinkovine, ki so substrati za citokrom P450 3A4 (CYP3A4).
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
The pharmacokinetics, efficacy and safety of Agenerase in combination with low doses of ritonavir or other protease inhibitors have not yet been evaluated in children.
Farmakokinetične lastnosti, učinkovitost in varnost zdravila Agenerase v kombinaciji z nizkimi odmerki ritonavirja ali z drugimi zaviralci proteaz pri otrocih še niso bile ovrednotene, zato se je takšnim kombinacijam pri otrocih potrebno izogibati.
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Neželeni učinki so navedeni po organskih sistemih in po pogostnosti glede na MedDRA podatkovno bazo.
Amprenavir is primarily metabolised in the liver by CYP3A4.
Amprenavir se primarno presnavlja v jetrih s CYP3A4.
Agenerase in combination with ritonavir is contraindicated in patients with severe hepatic impairment.
Zdravilo Agenerase je v kombinaciji z ritonavirjem kontraindicirano pri bolnikih s hudo obliko oslabljenega delovanja jeter.
The other ingredients within the capsule are d-alpha tocopheryl polyethylene glycol 1000 succinate (TPGS), macrogol 400 (polyethylene glycol 400) and propylene glycol.
Pomožne snovi vsebine kapsule so: D-α-tokoferilpolietilenglikol 1000 sukcinat (TPGS), makrogol 400 (polietilenglikol 400) in propilenglikol.
These include substances such as: clozapine, cimetidine, dapsone and loratadine.
Druge učinkovine: Amprenavir lahko zviša plazemske koncentracije drugih zdravilnih učinkovin, kot so: klozapin, cimetidin, dapson in loratadin.
The AUC, Cmax and Cmin of amprenavir were increased by 130%, 40% and 125% respectively.
AUC, Cmax in Cmin amprenavirja so se zvečale: AUC za 130 %, Cmax za 40 % in Cmin za 125 %.
Amprenavir was not mutagenic or genotoxic in a battery of in vivo and in vitro genetic toxicity assays, including bacterial reverse mutation (Ames Test), mouse lymphoma, rat micronucleus, and chromosome aberration in human peripheral lymphocytes.
Z in vitro in in vivo testi genotoksičnosti, vključno z bakterijsko reverzno mutacijo (Ames test), mišjimi limfomi, s podganjimi mikronukleusi in kromosomsko aberacijo na humanih perifernih limfocitih, je bilo ugotovljeno, da amprenavir ni mutagen ali genotoksičen.
Agenerase oral solution should not be used in patients with hepatic impairment or failure (see section 4.3).
Peroralna raztopina Agenerase se ne sme uporabljati pri bolnikih z oslabljenim delovanjem ali odpovedjo jeter (glejte poglavje 4.3).
The choice of Agenerase will be based on any resistance testing your doctor may have carried out and your treatment history.
Zdravnik bo/je zdravilo Agenerase izbral na osnovi testov odpornosti virusa in na osnovi podatkov o vašem predhodnem zdravljenju.
Do not store above 30°C.
Shranjujte pri temperaturi do 30 ºC.
Caution must also be exercised if Agenerase is used concurrently with atorvastatin, which is metabolized to a lesser extent by CYP3A4.
Previdnost je potrebna tudi ob sočasni uporabi zdravila Agenerase in atorvastatina, presnova slednjega je sicer manj odvisna od CYP3A4.
QUALITATIVE AND QUANTITATIVE COMPOSITION Agenerase oral solution contains 15 mg/ml of amprenavir.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Peroralna raztopina Agenerase vsebuje 15 mg/ml amprenavirja.