FrancophonIA/ELRC3.0 huggingface dataset:
English: When it is clinically necessary to co-administer rifabutin with Agenerase, a dosage reduction of at least half the recommended dose of rifabutin is advised, although no clinical data are available.
Slovenian: Kadar je klinično nujno potrebna sočasna uporaba rifabutina in zdravila Agenerase, svetujemo zmanjšanje odmerka rifabutina na najmanj polovico priporočenega odmerka, čeprav klinični podatki niso na voljo.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations of amprenavir is between 1-2 hours for the capsule and 0.5 to 1 hour for the oral solution.
Slovenian: Po zaužitju je srednji čas (tmax) do največje serumske koncentracije amprenavirja znašal za kapsule 1-2 uri in za peroralno raztopino približno 0,5-1 ure.
English: Such combinations should be avoided in patients with hepatic impairment.
Slovenian: Takim kombinacijam se je potrebno izogibati pri bolnikih z oslabljenim delovanjem jeter.
English: Rashes were usually mild to moderate, erythematous or maculopapular cutaneous eruptions, with or without pruritus, occurring during the second week of therapy and resolving spontaneously within two weeks, without discontinuation of treatment with amprenavir.
Slovenian: Izpuščaji so bili običajno v obliki blažjih do zmernih, srbečih ali nesrbečih, eritemskih ali makulopapuloznih kožnih eflorescenc, ki so se pojavile med drugim tednom zdravljenja in brez prekinitve zdravljenja z amprenavirjem izginile spontano v dveh tednih.
English: A 20 ml measuring cup is provided in the pack.
Slovenian: V škatlici je priložen 20 ml odmerni lonček.
English: Prior number of PIs taken [n (%)]
Slovenian: Število predhodno uporabljenih PI-jev [n (%)]
English: Concentrations of AAG have been shown to decrease during the course of antiretroviral therapy.
Slovenian: Pokazalo se je, da se koncentracije AAG med protiretrovirusnim zdravljenjem zmanjšujejo.
English: Elevated triglycerides, elevated amylase, abnormal fat redistribution, anorexia
Slovenian: zvišanje vrednosti trigliceridov, zvišanje vrednosti amilaze, nenormalna prerazdelitev maščevja, anoreksija
English: In male mice altered hepatocellular foci were seen at doses that were at least 2.0 times human therapeutic exposure.
Slovenian: Pri mišjih samcih so bila pri odmerkih, ki so bili vsaj 2,0-krat večji od terapevtske izpostave pri človeku, opažena spremenjena hepatocelularna žarišča.
English: • Non-nucleoside reverse transcriptase inhibitors (NNRTIs):
Slovenian: • Nenukleozidni zaviralci reverzne transkriptaze (NNRTI-ji):
English: If you are taking the contraceptive pill, it is recommended that you use an alternative method (e.g. a condom) to prevent pregnancy while you are taking Agenerase.
Slovenian: Če za preprečevanje zanositve jemljete kontracepcijske tablete, je priporočljivo, da uporabljate drugo metodo (npr. kondom) in tako preprečite nosečnost v času jemanja zdravila Agenerase.
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Slovenian: Poročali so tudi o bolečinah, mlahavosti in nemoči mišic, še posebej pri protiretrovirusnem zdravljenju, ki je vključevalo zaviralce proteaz in nukleozidne analoge.
English: Similarly, amprenavir and ritonavir might also modify the pharmacokinetics of other medicinal products that share this metabolic pathway.
Slovenian: Podobno lahko tudi amprenavir in ritonavir spremenita farmakokinetične lastnosti drugih zdravil, ki si delijo to presnovno pot.
English: 240 soft capsules
Slovenian: 240 mehkih kapsul
English: Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Slovenian: Kombinirano protiretrovirusno zdravljenje lahko povzroči določene spremembe v porazdelitvi telesnega maščevja, kar se odraža s spremembami telesne oblike.
English: 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.
Slovenian: Zdravila za zdravljenje erektilne disfunkcije: Na osnovi podatkov za druge zaviralce proteaz je ob predpisovanju zaviralcev PDE5 (npr. sildenafil in vardenafil) bolnikom, ki prejemajo zdravilo Agenerase, potrebna previdnost.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Slovenian: V primeru indikacije za zdravljenje z zaviralci HMG-CoA reduktaze sta priporočena pravastatin in fluvastatin.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort.
Slovenian: Inducirajoči učinek lahko vztraja še najmanj 2 tedna po opustitvi zdravljenja s pripravki iz šentjanževke.
English: When ritonavir is co-administered, the effect on hormonal contraceptive concentrations cannot be predicted, therefore, alternative methods of contraception are also recommended.
Slovenian: Ob sočasni uporabi ritonavirja se učinek na koncentracije hormonskih kontraceptivov ne more predvideti, zato so tudi v primeru takšnega načina zdravljenja priporočene alternativne kontracepcijske metode.
English: Many of the patients had confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Slovenian: Mnogi bolniki so imeli še druga obolenja, nekateri od njih so potrebovali zdravljenje z zdravili, ki so sama po sebi povezana s pojavom sladkorne bolezni ali hiperglikemijo.
English: If Agenerase with or without ritonavir is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Slovenian: Če je zdravilo Agenerase z ritonavirjem ali brez dano sočasno s parenteralno apliciranim midazolamom, naj se to zgodi na oddelku za intenzivno nego ali podobnem oddelku, ki omogoča skrbno klinično spremljanje bolnika in ustrezno ukrepanje v primeru respiratorne depresije in/ali podaljšane sedacije.
English: The usual dose for Agenerase capsules is 20 mg for each kg of body weight, twice a day.
Slovenian: Običajen odmerek kapsul Agenerase je 20 mg na vsak kilogram telesne teže, dvakrat dnevno.
English: Important information about ingredients of Agenerase capsules These capsules contain glycerol, which can cause adverse effects in high doses.
Slovenian: Pomembne informacije o nekaterih sestavinah kapsul Agenerase Te kapsule vsebujejo glicerol, ki lahko pri velikih odmerkih povzroči neželene učinke.
English: Discard the oral solution 15 days after first opening the bottle.
Slovenian: 15 dni po prvem odprtju plastenke peroralno raztopino zavrzite.
English: When amprenavir is combined with ritonavir, the effect of efavirenz is compensated by the pharmacokinetic booster effect of ritonavir.
Slovenian: Če je amprenavir kombiniran z ritonavirjem, je učinek efavirenza kompenziran z ritonavirjevim učinkom okrepitve farmakokinetičnih lastnosti amprenavirja.
English: Renal clearance of ritonavir is also negligible; therefore the impact of renal impairment on amprenavir and ritonavir elimination should be minimal.
Slovenian: Ledvični očistek ritonavirja je prav tako malenkosten, tako je vpliv oslabljenega delovanja ledvic na izločanje amprenavirja in ritonavirja minimalen.
English: The subsequent development of the offspring, including fertility and reproductive performance, was not affected by the maternal administration of amprenavir.
Slovenian: Nadaljnji razvoj takšnih mladičev, vključno z njihovo sposobnostjo za razmnoževanje in kakovostjo razmnoževanja, ni kazal posledic tega, da so njihove matere dobivale amprenavir.
English: Rash / cutaneous reactions
Slovenian: Eksantem/kožne reakcije
English: Alternative methods of contraception are recommended for women of childbearing potential.
Slovenian: Za ženske v rodni dobi je priporočljiva uporaba alternativnih kontracepcijskih metod.
English: This change will decrease the total active substance concentration in the plasma, however the amount of unbound amprenavir, which is the active moiety, is likely to be unchanged.
Slovenian: Ta sprememba zmanjša skupno plazemsko koncentracijo učinkovine, pri čemer količina aktivnega nevezanega amprenavirja verjetno ostane nespremenjena.
English: Oral use Read the package leaflet before use
Slovenian: Peroralna uporaba Pred uporabo preberite priloženo navodilo.
English: Treatment with Agenerase has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Slovenian: Ni bilo dokazano, da bi zdravljenje z zdravilom Agenerase zmanjšalo tveganje za prenos okužbe z virusom HIV med spolnim stikom ali s krvjo.
English: Most undesirable effects associated with Agenerase therapy were mild to moderate in severity, early in onset, and rarely treatment limiting.
Slovenian: Večina neželenih učinkov, povezanih z zdravljenjem z zdravilom Agenerase, je blagih do zmernih, zgodnjega pojava in le redko zahteva omejitev zdravljenja.
English: When used with Agenerase with ritonavir, high doses (>200 mg/day) of ketoconazole or itraconazole are not recommended.
Slovenian: Pri sočasni uporabi skupaj z zdravilom Agenerase in ritonavirjem uporaba visokih odmerkov (> 200 mg/dan) ketokonazola ali itrakonazola ni priporočljiva.
English: Most patients with mild or moderate rash can continue Agenerase.
Slovenian: Večina bolnikov z blagim ali zmernim kožnim izpuščajem lahko nadaljuje zdravljenje z zdravilom Agenerase.
English: Adverse events considered associated with the use of Agenerase are gastro-intestinal symptoms, rash and oral/peri-oral paraesthesia.
Slovenian: Neželeni učinki, za katere se predpostavlja, da so povezani z uporabo zdravila Agenerase, so gastrointestinalni simptomi, eksantem in oralna/perioralna parestezija.
English: Clinically significant binding displacement interactions involving medicinal products primarily bound to AAG are generally not observed.
Slovenian: Na splošno niso opazili klinično pomembnih interakcij zaradi izpodrivanja z zdravili, ki se primarno vežejo na AAG.
English: • Tingling or numbness around the lips and mouth, uncontrolled movements
Slovenian: • Občutek gomazenja po ustnicah in v ustih, nenadzorovani gibi.
English: It is therefore recommended that women of child-bearing potential taking Agenerase should practice effective contraception (e.g. barrier methods).
Slovenian: Priporočljivo je torej, da ženske, ki v rodni dobi jemljejo zdravilo Agenerase, uporabljajo zanesljivo kontracepcijsko metodo (npr. mehanska kontracepcija).
English: Elderly: the pharmacokinetics, efficacy and safety of amprenavir have not been studied in patients over 65 years of age (see section 5.2).
Slovenian: Starejši: Farmakokinetične lastnosti, učinkovitost in varnost amprenavirja pri bolnikih, starejših od 65 let, niso bile raziskane (glejte poglavje 5.2).
English: The 50% inhibitory concentration (IC50) of amprenavir ranged from 0.012 to 0.08 µM in acutely infected cells and was 0.41 µM in chronically infected cells (1 µM = 0.50 µg/ml).
Slovenian: Pri akutno okuženih celicah se je 50 % inhibitorna koncentracija (IC50) amprenavirja gibala med 0,012 in 0,08 μM, pri kronično okuženih celicah pa je bila 0,41 μM; (1 μM = 0,50 μg/ml).
English: Calcium-channel blockers: amprenavir may lead to increased serum concentrations of calcium channel blockers such as amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine and verapamil, possibly resulting in enhanced activity and toxicity of these medicinal products.
Slovenian: Zaviralci kalcijevih kanalčkov: Amprenavir lahko povzroči povišanje serumskih koncentracij zaviralcev kalcijevih kanalčkov, kot so amlodipin, diltiazem, felodipin, isradipin, nikardipin, nifedipin, nimodipin, nisoldipin in verapamil, kar ima lahko za posledico okrepljen učinek in toksičnost teh zdravil.
English: If you need to take an antacid for indigestion, or if you are taking a drug containing an antacid (e.g. didanosine), you are advised to take it more than an hour before or after Agenerase, otherwise the effects of Agenerase may be reduced.
Slovenian: Če morate zaradi prebavnih težav jemati antacid ali če boste vzeli zdravilo z antacidom (npr. didanozin), svetujemo, da ga vzamete z več kot enournim presledkom pred zdravilom Agenerase ali po njem, sicer je učinek zdravila Agenerase lahko slabši.
English: A reproduction study in pregnant rats dosed from the time of uterine implantation through lactation showed reduced body weight gains in the offspring during the nursing period.
Slovenian: Študija o vplivu na sposobnost razmnoževanja pri brejih podganah, ki so odmerke prejemale od trenutka nidacije v maternici do konca dojenja, je pokazala, da so mladiči v času dojenja manj pridobivali na teži.
English: Didanosine: no pharmacokinetic study has been performed with Agenerase in combination with didanosine, however, due to its antacid component, it is recommended that didanosine and Agenerase should be administered at least one hour apart (see Antacids below).
Slovenian: Didanozin: Farmakokinetične študije o sočasni uporabi zdravila Agenerase in didanozina niso bile izvedene, vendar se zaradi njegovega antacidnega delovanja priporoča, da se didanozin in zdravilo Agenerase uporabljata vsaj z enournim presledkom (glejte Antacidi spodaj).
English: These dosing regimens will provide plasma amprenavir levels comparable to those achieved in healthy subjects given a 1200 mg dose twice daily without concomitant administration of ritonavir.
Slovenian: Takšen način odmerjanja zagotavlja vrednosti amprenavirja v plazmi, ki so primerljive s tistimi pri zdravih osebah, ki prejemajo amprenavir v odmerku 1200 mg dvakrat dnevno brez sočasnega dajanja ritonavirja.
English: If overdose occurs, the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment provided as necessary.
Slovenian: V primeru prevelikega odmerjanja je potrebno bolnika nadzirati glede znakov toksičnosti (glejte poglavje 4.8) in po potrebi zagotoviti običajno podporno terapijo.
English: At present, there is insufficient information to recommend the use of Agenerase in children less than four years of age.
Slovenian: Na osnovi trenutno razpoložljivih podatkov se uporaba zdravila Agenerase pri otrocih, mlajših od štirih let, ne priporoča.
English: Adding additional ritonavir to an amprenavir plus Kaletra regimen increase lopinavir Cmin values, but not amprenavir Cmin values.
Slovenian: Dodatno dodajanje ritonavirja h kombinaciji amprenavir plus zdravilo Kaletra je zvišalo vrednosti Cmin lopinavirja, ne pa vrednosti Cmin amprenavirja.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Slovenian: Če opazite kakršnekoli znake okužbe, prosimo, da o tem takoj obvestite svojega zdravnika.
English: Mood disorders, depressive disorders Nervous system disorders
Slovenian: razpoloženjske motnje, depresivne motnje
English: A higher incidence of rash was reported in patients treated with amprenavir in combination with efavirenz.
Slovenian: O večji pojavnosti eksantema so poročali pri bolnikih, ki so se zdravili z amprenavirjem v kombinaciji z efavirenzom.
English: When amprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor.
Slovenian: Če se amprenavir in ritonavir dajeta sočasno, lahko prevlada presnovni interakcijski profil ritonavirja, saj je ritonavir močnejši zaviralec CYP3A4.
English: If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin are recommended (see section 4.5).
Slovenian: Ob indikacijah za zdravljenje z zaviralci HMG-CoA reduktaze sta priporočena pravastatin ali fluvastatin (glejte poglavje 4.5).
English: Due to the potential risk of toxicity from the high propylene glycol content of Agenerase oral solution, this formulation is contraindicated in children below the age of four years and should be used with caution in certain other patient populations.
Slovenian: Zaradi visoke vsebnosti propilenglikola v peroralni raztopini Agenerase in z njim povezane možne toksičnosti je ta oblika zdravila kontraindicirana pri otrocih, mlajših od štirih let, pri določenih drugih populacijah bolnikov pa je potrebna previdnost pri uporabi.
English: Hypersensitivity to the active substance or to any of the excipients.
Slovenian: Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov.
English: If you notice any of these symptoms please inform your doctor.
Slovenian: Če opazite katerega od teh simptomov, morate obvestiti zdravnika.
English: The mean AUC over a dosing interval of 12 hours is 18.46 μg.h/ml (3.0232.95).
Slovenian: Srednji AUC je pri odmerjanju na vsakih 12 ur znašal 18,46 µg.h/ml (3,02-32,95).
English: For subjects with hepatic impairment, pharmacokinetic data are available for the use of Agenerase capsules without the boosting effect of ritonavir.
Slovenian: Za osebe z oslabljenim delovanjem jeter so na voljo farmakokinetični podatki, ki se nanašajo na uporabo kapsul Agenerase brez ritonavirjevega učinka okrepitve.
English: Almost all subjects with abnormal liver function tests were co-infected with Hepatitis B or C virus.
Slovenian: Skoraj vsi bolniki, pri katerih so testi jetrnih funkcij odstopali od normalnih vrednosti, so bili sočasno okuženi z virusom hepatitisa B ali C. Bolezni kože in podkožja
English: EU/1/00/148/002 EU/1/00/148/003
Slovenian: EU/1/00/148/003
English: Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Slovenian: Hemofilike je tako potrebno opozoriti na možnost pogostnejših krvavitev.
English: Mean plasma HIV-1 RNA AAUCMB (log10 copies/ml)
Slovenian: Srednja plazemska vrednost HIV-1 RNA AAUCMB (log10 kopij/ml)
English: Since amprenavir is highly protein bound, dialysis is unlikely to be helpful in reducing blood levels of amprenavir.
Slovenian: Ker se amprenavir močno veže na proteine, je malo verjetno, da bi dializa koristila pri zniževanju njegovih vrednosti v krvi.
English: - If you have any other health concerns, discuss these with your doctor.
Slovenian: - Če imate kakršne koli druge zdravstvene težave ali pomisleke, se posvetujte s svojim zdravnikom.
English: The concomitant use of Agenerase and contraceptive pill may result in a decrease of the therapeutic effect of Agenerase.
Slovenian: Sočasna uporaba zdravila Agenerase in kontracepcijskih tablet lahko povzroči slabši zdravilni učinek zdravila Agenerase.
English: Further, if efavirenz is given in combination with amprenavir and nelfinavir, no dosage adjustment is necessary for any of the medicinal products.
Slovenian: Če se efavirenz daje v kombinaciji z amprenavirjem in nelfinavirjem, ni potrebno za nobenega izmed teh zdravil prilagajati odmerkov.
English: One or two white High Density Polyethylene (HDPE) bottles, each containing 240 capsules.
Slovenian: Ena ali dve beli plastenki iz polietilena visoke gostote (HDPE), vsaka vsebuje 240 kapsul.
English: No dose recommendation can be given for the coadministration of amprenavir and Kaletra, but close monitoring is advised because the safety and efficacy of this combination is unknown.
Slovenian: Glede sočasnega dajanja amprenavirja in zdravila Kaletra ne moremo podati priporočenih odmerkov, svetujemo pa temeljito nadziranje, saj sta varnost in učinkovitost takšne kombinacije neznani.
English: This liver toxicity can be monitored for and detected in clinical use, with measurements of AST, ALT and alkaline phosphatase activity.
Slovenian: Tovrstne posledice se lahko v klinični uporabi nadzirajo in odkrijejo z meritvami vrednosti AST, ALT in aktivnosti alkalne fosfataze.
English: Renal impairment: patients with renal impairment have not been specifically studied.
Slovenian: Oslabljeno delovanje ledvic: Bolnikov z oslabljenim delovanjem ledvic niso posebej preučevali.
English: If Agenerase makes you dizzy, do not operate any tools or machines.
Slovenian: Če se zaradi zdravljenja z zdravilom Agenerase počutite omotične, vozil in strojev ali orodij ne smete upravljati.
English: Co-administration of amprenavir with methadone leads to a decrease of methadone concentrations.
Slovenian: Sočasna uporaba amprenavirja z metadonom vodi v znižanje koncentracij slednjega.
English: Treatment with efavirenz in combination with amprenavir and saquinavir is not recommended, as the exposure to both protease inhibitors would be decreased.
Slovenian: Zdravljenje z efavirenzom v kombinaciji z amprenavirjem in s sakvinavirjem ni priporočljivo, ker bo izpostava obema zaviralcema proteaz zmanjšana.
English: 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.
Slovenian: Medtem ko absolutne koncentracije proste učinkovine ostanejo konstantne, se med odmernim intervalom odstotek proste učinkovine skladno s celokupno koncentracijo aktivne učinkovine v stanju dinamičnega ravnovesja spreminja od Cmax,ss do Cmin,ss.
English: The safety of Agenerase has been studied in adults and children at least 4 years of age, in controlled clinical trials, in combination with various other antiretroviral agents.
Slovenian: Varnost zdravila Agenerase je bila raziskovana pri odraslih in otrocih, starejših od 4 let, v nadzorovanih kliničnih študijah in v kombinaciji s številnimi drugimi protiretrovirusnimi zdravili.
English: If you are taking certain medicines that can cause serious side effects, such as carbamazepine, phenobarbital, phenytoin, lidocaine, cyclosporine, tacrolimus, rapamycin, tricyclic antidepressants and warfarin, at the same time as you are taking Agenerase, your doctor may carry out additional blood tests to minimise any potential safety problems.
Slovenian: Če sočasno z zdravilom Agenerase jemljete še določena zdravila, kot so karbamazepin, fenobarbital, fenitoin, lidokain, ciklosporin, takrolimus, rapamicin, triciklični antidepresivi in varfarin, ki lahko povzročijo resne neželene učinke, bo vaš zdravnik verjetno opravil dodatne krvne preiskave in tako zmanjšal verjetnost morebitnih težav, povezanih z varno uporabo teh zdravil.
English: Some substances (e.g. lidocaine (by systemic route) and halofantrine) given with Agenerase may cause serious adverse reactions.
Slovenian: Nekatere učinkovine (npr. lidokain (sistemska uporaba) in halofantrin) lahko pri sočasni uporabi z zdravilom Agenerase povzročijo resne neželene reakcije.
English: The use of Agenerase concomitantly with halofantrine or lidocaine (systemic) is not recommended (see section 4.5).
Slovenian: Sočasne uporabe zdravila Agenerase in halofantrina ali lidokaina (sistemskega) ne priporočamo (glejte poglavje 4.5).
English: If Agenerase capsules are used without the boosting effect of ritonavir higher doses of Agenerase (1200 mg twice daily) should be used.
Slovenian: Če se kapsule Agenerase uporabljajo brez ritonavirja (ni njegovega učinka okrepitve), je potrebno uporabiti višje odmerke zdravila Agenerase (1200 mg dvakrat dnevno).
English: The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace amounts of amprenavir.
Slovenian: Protivirusna aktivnost fosamprenavirja, opažena in vitro, je posledica prisotnosti amprenavirja v sledeh.
English: The inducing effect may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Slovenian: Inducirajoči učinek lahko vztraja še najmanj 2 tedna po opustitvi zdravljenja s pripravki iz šentjanževke (glejte poglavje 4.3).
English: For many of these events it is unclear whether they are related to Agenerase, to concomitant treatment used in the management of HIV disease or to the disease process.
Slovenian: Za mnoge izmed teh učinkov ni jasno, če so povezani z zdravilom Agenerase, drugimi zdravili, ki se sočasno uporabljajo za zdravljenje okužbe z virusom HIV, ali s samim bolezenskim procesom.