FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of Agenerase with ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Slovenian: Sočasne uporabe zdravila Agenerase v kombinaciji z ritonavirjem in flutikazonom ali drugimi glukokortikoidi, ki se presnavljajo s CYP3A4, ne priporočamo, razen v primerih, ko možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in z zaviralnim vplivom na nadledvično žlezo (glejte poglavje 4.5).
English: You should take Agenerase capsules as soon as you are able to swallow them.
Slovenian: Zdravilo Agenerase morate pričeti jemati v obliki kapsul takoj, ko jih boste lahko pogoltnili.
English: 15 mg/ml amprenavir
Slovenian: Agenerase 15 mg/ml peroralna raztopina amprenavir
English: 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, patients with renal failure, and patients treated with disulfiram or metronidazole or preparations that contain alcohol (e.g. ritonavir oral solution) or additional propylene glycol (see also Take special care with Agenerase).
Slovenian: Zaradi velike količine pomožne snovi propilenglikola 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, bolnikih z odpovedjo ledvic in bolnikih, ki se zdravijo z disulfiramom, metronidazolom, s pripravki, ki vsebujejo alkohol (npr. peroralna raztopina ritonavirja) ali pripravki z dodatnim propilenglikolom (glejte tudi Previdnost in posebna opozorila pri uporabi).
English: Agenerase with ritonavir must not be co-administered with medicinal products with narrow therapeutic windows that are highly dependent on CYP2D6 metabolism, e.g. flecainide and propafenone (see section 4.5).
Slovenian: Zdravilo Agenerase v kombinaciji z ritonavirjem se ne sme dajati sočasno z zdravili ozke terapevtske širine, ki so močno odvisni od presnove z CYP2D6, npr. flekainid in propafenon (glejte poglavje 4.5).
English: Diarrhoea, nausea, flatulence, vomiting
Slovenian: driska, navzea, flatulenca, bruhanje
English: Agenerase oral solution contains a large amount of propylene glycol (see section 4.4).
Slovenian: Peroralna raztopina Agenerase vsebuje velike količine propilenglikola (glejte poglavje 4.4).
English: Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Agenerase (see section 4.5).
Slovenian: Priporočamo nadziranje terapevtskih koncentracij zdravil za zaviranje imunske odzivnosti (ciklosporin, takrolimus, rapamicin), če se jih uporablja skupaj z zdravilom Agenerase (glejte poglavje 4.5).
English: Pack contents : Two bottles each containing 240 soft capsules
Slovenian: Škatlica vsebuje: dve plastenki, v vsaki je 240 mehkih kapsul.
English: Therefore this combination must be avoided.
Slovenian: Pri uporabi tovrstne kombinacije je potrebna previdnost.
English: The importance of complying with the full recommended dosing regimen should be stressed to all patients.
Slovenian: Vsem bolnikom je potrebno poudariti pomembnost natančnega upoštevanja predpisanega načina odmerjanja zdravila.
English: If a patient is already taking St John's wort, check amprenavir and if possible viral levels and stop St John's wort.
Slovenian: Če bolnik že jemlje pripravke iz šentjanževke, je potrebno preveriti vrednosti amprenavirja in po možnosti virusa ter prenehati jemati pripravke iz šentjanževke.
English: Very Common:
Slovenian: Zelo pogosti:
English: - Swallow Agenerase capsules whole with water or another drink.
Slovenian: - Kapsule Agenerase pogoltnite cele, z vodo ali drugo tekočino.
English: Agenerase capsules should normally be given in combination with low dose ritonavir and in combination with other antiretroviral agents (see section 4.2).
Slovenian: Kapsule Agenerase se morajo praviloma dajati v kombinaciji z nizkim odmerkom ritonavirja in v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.2).
English: Dosages of 20 mg/kg twice a day and 15 mg/kg three times a day with Agenerase capsules provided similar daily amprenavir exposure to 1200 mg twice a day in adults.
Slovenian: Pri odmerjanju 20 mg/kg dvakrat dnevno in 15 mg/kg trikrat dnevno so za kapsule Agenerase ugotovili podobno dnevno izpostavo amprenavirju kot pri odraslih, ki so prejemali odmerek 1200 mg dvakrat dnevno.
English: This medicinal product also contains 1 mg potassium per ml.
Slovenian: To zdravilo vsebuje tudi 1 mg kalija na ml.
English: Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Slovenian: Kombinirano protiretrovirusno zdravljenje je bilo pri bolnikih, okuženih z virusom HIV, povezano s prerazdelitvijo telesnega maščevja (lipodistrofija), vključno z izgubo perifernega in obraznega podkožnega maščevja, povečanjem intraabdominalnega in visceralnega maščevja, hipertrofijo dojk in dorzocervikalno akumulacijo maščevja (bivolja grba).
English: Lopinavir / ritonavir (Kaletra): in an open-label, non-fasting pharmacokinetic study, the AUC, Cmax and Cmin of lopinavir were decreased by 38%, 28% and 52% respectively when amprenavir (750 mg twice daily) was given in combination with Kaletra (400 mg lopinavir + 100 mg ritonavir twice daily).
Slovenian: Lopinavir/ritonavir (Kaletra): V odprti farmakokinetični študiji so se AUC, Cmax in Cmin lopinavirja zmanjšale, in sicer AUC za 38 %, Cmax za 28 % in Cmin za 52 %, če so amprenavir (750 mg dvakrat dnevno) dajali v kombinaciji z zdravilom Kaletra (400 mg lopinavirja + 100 mg ritonavirja dvakrat dnevno).
English: Bone problems
Slovenian: Težave s kostmi
English: When ritonavir is co-administered a larger increase in rifabutin concentration may occur.
Slovenian: Sočasna uporaba ritonavirja lahko vodi do večjega povišanja koncentracije rifabutina.
English: Current antiretroviral therapies, including Agenerase, have not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Slovenian: Ni dokazov, da bi trenutno razpoložljiva protiretrovirusna zdravljenja, vključno z zdravilom Agenerase, lahko preprečila prenos virusa HIV med spolnim stikom ali z okuženo krvjo.
English: The evidence of efficacy of Agenerase in combination with ritonavir 100 mg twice daily is based on study PRO30017, a randomized, open-label study, in which PI-experienced adults experiencing virological failure (viral load ≥1000 copies/ml) received either Agenerase (600 mg twice daily) in combination with ritonavir (100 mg twice daily) and nucleoside analogues (NRTI) or a standard of care (SOC) PI, predominantly boosted with low-dose RTV.
Slovenian: Dokaz učinkovitosti zdravila Agenerase v kombinaciji z ritonavirjem v odmerku 100 mg dvakrat na dan temelji na randomizirani odprti študiji PRO30017, v kateri so bolniki z virusnim neodzivom (virusna obremenitev ≥ 1.000 kopij /ml), ki so se že zdravili s PI-ji, prejemali bodisi zdravilo Agenerase (600 mg dvakrat na dan) v kombinaciji z ritonavirjem (100 mg dvakrat na dan) in nukleozidne analoge (NRTI-je) ali pa so bili standardno zdravljeni s PI-ji, predvsem z okrepitvijo z nizkim odmerkom RTV.
English: Abdominal pain, abdominal discomfort, dyspeptic symptoms, loose stools
Slovenian: abdominalna bolečina, nelagoden občutek v trebuhu, simptomi dispepsije, neredna stolica
English: Co-administration of 0.035 mg ethinyl estradiol plus 1.0 mg norethindrone resulted in a decrease of the amprenavir AUC and Cmin of 22% and 20% respectively, Cmax being unchanged.
Slovenian: Sočasna uporaba 0,035 mg etinilestradiola in 1,0 mg noretindrona je imela za posledico zmanjšanje AUC in Cmin amprenavirja: AUC za 22 % in Cmin za 20 %, Cmax amprenavirja pa je ostala nespremenjena.
English: Liver Disease: The safety and efficacy of amprenavir has not been established in patients with significant underlying liver disorders.
Slovenian: Jetrno obolenje: Pri bolnikih z znatnimi osnovnimi boleznimi jeter varnost in učinkovitost amprenavirja nista bili dokazani.
English: Methadone and opiate derivatives: co-administration of methadone with amprenavir resulted in a decrease in the Cmax and AUC of the active methadone enantiomer (R-enantiomer) of 25% and 13% respectively, whilst the Cmax, AUC and Cmin of the inactive methadone enantiomer (S-enantiomer) were decreased by 48%, 40% and 23% respectively.
Slovenian: Metadon in opiatni derivati: Sočasna uporaba metadona in amprenavirja je imela za posledico zmanjšanje Cmax in AUC aktivnega metadonovega enantiomera (R-enantiomer), in sicer Cmax za 25 % in AUC za 13 %, medtem ko so se Cmax, AUC in Cmin neaktivnega metadonovega enantiomera (Senantiomer) tudi zmanjšale: Cmax za 48 %, AUC za 40 % in Cmin za 23 %.
English: Agenerase 150 mg soft capsules are supplied in a pack with two plastic bottles each containing 240 soft capsules.
Slovenian: Agenerase 150 mg mehke kapsule so na voljo v škatlici, ki vsebuje dve plastenki po 240 mehkih kapsul.
English: Symptoms of abnormal fat redistribution were infrequent in PROAB3001 with amprenavir.
Slovenian: V študiji PROAB3001 so bili znaki nenormalne prerazdelitve maščevja med zdravljenjem z amprenavirjem redki.
English: The capsule shell contains gelatin, glycerol, d-sorbitol and sorbitans solution, titanium dioxide and red printing ink.
Slovenian: Ovojnica kapsule vsebuje: želatino, glicerol, raztopino dsorbitola in sorbitanov, titanov dioksid in rdeče črnilo za tisk.
English: - Agenerase capsules (without the boosting effect of ritonavir) have been studied in patients with liver impairment.
Slovenian: - Uporaba kapsul Agenerase (brez ritonavirja, ki bi okrepil njihov učinek) je bila raziskana pri bolnikih z oslabljenim delovanjem jeter.
English: 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).
Slovenian: V 48. tednu so bile pri približno 25 % vključenih otrok plazemske vrednosti HIV-1 RNA < 10.000 kopij/ml in pri 9 % < 400 kopij/ml.
English: 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).
Slovenian: 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 56 tednov (srednji čas zdravljenja, p < 0,001) zdravile z indinavirjem v kombinaciji z različnimi NRTI-ji.
English: There is also insufficient information to recommend the use of Agenerase capsules boosted with ritonavir in children of 4 to 12 years of age or any patients weighing less than fifty kilograms.
Slovenian: Ravno tako se ne priporoča uporaba kapsul Agenerase skupaj z ritonavirjem (ritonavir okrepi učinkovanje kapsul Agenerase) pri otrocih, starih od 4 do 12 let, ali pri katerem koli bolniku s telesno težo, manjšo od 50 kilogramov, saj trenutno razpoložljivi podatki ne zadostujejo za tovrstno priporočilo.
English: Therefore, alternative reliable methods of contraception are recommended for women of childbearing potential (see section 4.5).
Slovenian: Pri ženskah v rodni dobi se tako priporočajo druge, učinkovite in varne kontracepcijske metode (glejte poglavje 4.5).
English: Liver toxicity consisted of increases in liver enzymes, liver weights and microscopic findings including hepatocyte necrosis.
Slovenian: Toksični učinki na jetra so se pokazali predvsem v obliki porasta vrednosti jetrnih encimov, teže jeter in v mikroskopskih spremembah, vključno z nekrozo hepatocitov.
English: Hepatic impairment: 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)
Slovenian: Oslabljeno delovanje jeter: Peroralna raztopina Agenerase je kontraindicirana pri bolnikih z oslabljenim delovanjem ali odpovedjo jeter (glejte poglavje 4.3; glede podatkov o predpisovanju glejte Povzetek glavnih značilnosti zdravila za kapsule Agenerase).
English: Genotypic analysis of isolates from 13 of 14 paediatric patients exhibiting virological failure among the 59 PI-naïve patients enrolled, demonstrated resistance patterns similar to those observed in adults.
Slovenian: Pri 13 bolnikih z virusnim neodzivom so z genotipsko analizo izolatov ugotovili podoben vzorec rezistence kot pri odraslih bolnikih.
English: Most of the adverse events below come from two clinical trials (PROAB3001, PROAB3006) involving PI naïve subjects receiving Agenerase 1200mg twice daily.
Slovenian: Večina navedenih neželenih učinkov izhaja iz dveh kliničnih študij (PROAB3001, PROAB3006), ki sta vključevali osebe, ki so prejemale zdravilo Agenerase v odmerku 1200 mg dvakrat dnevno in s PIji predhodno še niso bile zdravljene.
English: Baseline characteristics Median HIV-1 RNA (log10 copies/ml) (range)
Slovenian: Izhodiščne značilnosti Srednja vrednost HIV1 RNA (log10 kopij/ml) (razpon)
English: Very Common: Common:
Slovenian: Zelo pogosti: Pogosti:
English: There are limited reports of overdose with Agenerase.
Slovenian: Poročila o prevelikem odmerjanju zdravila Agenerase so skopa.
English: Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with amprenavir (see section 4.4).
Slovenian: Zdravila za zaviranje imunske odzivnosti: Priporočamo redno nadziranje terapevtskih koncentracij zdravil za zaviranje imunske odzivnosti (dokler se vrednosti ne ustalijo), saj se plazemske koncentracije ciklosporina, rapamicina in takrolimusa lahko povečajo, če se jih uporablja sočasno z amprenavirjem (glejte poglavje 4.4).
English: Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5).
Slovenian: Kapsule Agenerase se morajo praviloma dajati skupaj z nizkim odmerkom ritonavirja, ki stopnjuje farmakokinetične lastnosti amprenavirja (glejte poglavji 4.2 in 4.5).
English: 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).
Slovenian: 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).
English: These active substances include flecainide and propafenone.
Slovenian: Takšni učinkovini sta tudi flekainid in propafenon.
English: A connection between visceral lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Slovenian: Domneva se, da gre za povezavo med visceralno lipomatozo in zaviralci proteaz ter lipoatrofijo in nukleozidnimi in nukleotidnimi zaviralci reverzne transkriptaze.
English: Antiretroviral agents
Slovenian: Protiretrovirusna zdravila
English: • Nucleoside analogue reverse transcriptase inhibitors (NRTIs):
Slovenian: • Zaviralci nukleotidne in nukleozidne reverzne transkriptaze (NRTI-ji):
English: 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.
Slovenian: 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.
English: The primary route of elimination of amprenavir is via hepatic metabolism with less than 3 % excreted unchanged in the urine.
Slovenian: Poglavitna pot izločanja amprenavirja iz telesa poteka preko presnove v jetrih, pri čemer se ga manj kot 3 % izloči v nespremenjeni obliki z urinom.
English: The primary route of metabolism is via the cytochrome P450 CYP3A4 enzyme.
Slovenian: Primarna presnovna pot poteka preko encima citokrom P450 CYP3A4.
English: Patients should discontinue Agenerase oral solution as soon as they are able to swallow the capsule formulation (see section 4.4).
Slovenian: Bolniki morajo opustiti jemanje peroralne raztopine Agenerase takoj, ko so zmožni pogoltniti zdravilo Agenerase v obliki kapsul (glejte poglavje 4.4).
English: This leaflet was last approved on
Slovenian: Navodilo je bilo odobreno:
English: Metabolism: amprenavir is primarily metabolised by the liver with less than 3 % excreted unchanged in the urine.
Slovenian: Presnova: Amprenavir se primarno presnavlja v jetrih, manj kot 3 % se ga v nespremenjeni obliki izloči z urinom.
English: Agenerase capsules contain vitamin E (36 IU/50 mg capsule), therefore additional vitamin E supplementation is not recommended.
Slovenian: Kapsule Agenerase vsebujejo vitamin E (36 i.e./50 mg kapsulo), zato ni priporočljiva dodatna uporaba vitamina E.
English: A higher incidence of hepatocellular carcinoma was seen in all amprenavir male mouse treatment groups.
Slovenian: Pri vseh skupinah mišjih samcev, ki so bile izpostavljene amprenavirju, je bila opažena višja pojavnost hepatocelularnih karcinomov.
English: Reduced susceptibility to amprenavir was associated with virus that had developed I50V or I84V or V32I+I47V or I54M mutations.
Slovenian: Zmanjšana občutljivost za amprenavir je bila povezana z virusom, pri katerem je prišlo do mutacij I50V ali I84V ali V32I+I47V ali I54M.
English: No drug interaction study has been performed for the co-administration of Agenerase with benzodiazepines.
Slovenian: Raziskave medsebojnega delovanja ob sočasni uporabi zdravila Agenerase in benzodiazepinov niso bile izvedene.
English: Amprenavir and ritonavir are primarily metabolised in the liver by CYP3A4.
Slovenian: Amprenavir in ritonavir se primarno presnavljata v jetrih s CYP3A4.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: (Note: Agenerase is not approved in ART-naive or PI-naive patients).
Slovenian: (Opozorilo: Zdravilo Agenerase ni odobreno za zdravljenje bolnikov, ki se še niso zdravili s protiretrovirusnimi zdravili ali z zaviralci proteaz).
English: Clarithromycin: the AUC and Cmin of clarithromycin were unaltered and the Cmax decreased by 10 % when given with amprenavir.
Slovenian: Klaritromicin: Ob sočasni uporabi z amprenavirjem sta AUC in Cmin klaritromicina ostali nespremenjeni, Cmax klaritromicina pa se je znižala za 10 %.
English: Agenerase oral solution contains vitamin E (46 IU/ml), therefore additional vitamin E supplementation is not recommended.
Slovenian: Peroralna raztopina Agenerase vsebuje vitamin E (46 i.e./ml), zato ni priporočljiva dodatna uporaba vitamina E.
English: Do not use Agenerase after the expiry date which is stated on the carton.
Slovenian: Zdravila Agenerase ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici.
English: 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).
Slovenian: 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).
English: The Cmin of ethinyl estradiol was increased by 32%, whilst the AUC and Cmin of norethindrone were increased by 18% and 45% respectively.
Slovenian: Cmin etinilestradiola se je zvišala za 32 %, medtem ko sta se AUC in Cmin noretindrona zvečali: AUC za 18 % in Cmin za 45 %.
English: Delavirdine: the AUC, Cmax and Cmin of delavirdine were decreased by 61%, 47% and 88% respectively when given with amprenavir.
Slovenian: 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 %.
English: Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Slovenian: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: When ritonavir is co-administered further dose reduction may be necessary (see section 4.5).
Slovenian: Pri sočasnem dajanju ritonavirja bo morda odmerek rifabutina potrebno še nadalje zmanjšati (glejte poglavje 4.5).
English: 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.
Slovenian: 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).
English: 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).
Slovenian: Peroralna raztopina Agenerase se med nosečnostjo zaradi možne, s propilenglikolom povezane toksičnosti za plod ne sme uporabljati (glejte poglavje 4.3).
English: Severe or life-threatening skin reactions have also occurred in patients treated with amprenavir (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili z amprenavirjem, pa so se pojavile tudi hude ali življenjsko usodne kožne reakcije (glejte poglavje 4.4).
English: 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.
Slovenian: 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.