FrancophonIA/ELRC3.0 huggingface dataset:
English: Take special care with Telzir Talk to your doctor or pharmacist before taking Telzir:
Slovenian: Bodite posebno pozorni pri jemanju zdravila Telzir Pred začetkom jemanja zdravila Telzir se posvetujte z zdravnikom ali farmacevtom.
English: magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172).
Slovenian: • Pomožne snovi so: mikrokristalna celuloza, premreženi natrijev karmelozat, povidon K30, magnezijev stearat, brezvodni koloidni silicijev dioksid, hipromeloza, titanov dioksid (E171), triacetin in rdeči železov oksid (E172).
English: Telzir does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila Telzir niso potrebna posebna navodila.
English: Increased bleeding may occur while taking protease inhibitors (such as Telzir).
Slovenian: Med jemanjem zaviralcev proteaz (kot je zdravilo Telzir) so krvavitve lahko hujše.
English: The median durations of prior exposure to protease inhibitors were 149 weeks for patients receiving fosamprenavir with ritonavir twice daily (49 % received ≥ 2 prior PIs) and 130 weeks for patients receiving lopinavir/ritonavir (40 % received ≥ 2 prior PIs).
Slovenian: Bolniki, ki so prejemali fosamprenavir v kombinaciji z ritonavirjem dvakrat dnevno, so bili pred tem v povprečju 149 tednov izpostavljeni zaviralcem proteaz (49 % jih je prejemalo ≥ 2 PI), bolniki, ki so prejemali lopinavir/ritonavir, pa 130 tednov (40 % jih je prejemalo ≥ 2 PI).
English: FPV/RTV BID (N=107)
Slovenian: FPV/RTV 2x/dan (N=107)
English: INFECTION Antibacterials:
Slovenian: Antibiotiki:
English: Cyclosporin Rapamycin Tacrolimus
Slovenian: ciklosporin rapamicin takrolimus
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Slovenian: Med kombiniranim protiretrovirusnim zdravljenjem so se pri bolnikih z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, pogosteje pojavljale nepravilnosti v jetrnem delovanju in jih je bilo potrebno nadzirati po splošno uveljavljenih načelih.
English: Very common side effects These may affect more than 1 in 10 people:
Slovenian: Neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 bolnikov:
English: Anti-hepatitis C virus medicinal products
Slovenian: Zdravila proti virusu hepatitisa C simeprevir daklatasvir
English: ANTINEOPLASTIC AGENTS METABOLISED BY CYP3A Examples of antineoplastic dasatinib: ↑ expected nilotinib: ↑ expected ibrutinib: ↑ expected vinblastine: ↑ expected
Slovenian: ANTINEOPLASTIČNE UČINKOVINE, KI SE METABOLIZIRAJO S CYP3A Primeri antineoplastičnih učinkovin: dasatinib nilotinib ibrutinib dasatinib:  pričakovano nilotinib:  pričakovano ibrutinib:  pričakovano vinblastin:  pričakovano everolimus:  pričakovano
English: APV29005 enrolled 30 patients aged 6 to 11 (the majority of whom were treated with fosamprenavir / ritonavir 18/3 mg/kg twice daily or the adult tablet regimen) and 40 patients aged 12 to 18 (the majority of whom were treated with the adult tablet regimen).
Slovenian: V študijo APV29005 je bilo vključenih 30 bolnikov, starih od 6 do 11 let (večina je bila zdravljena s fosamprenavirjem/ritonavirjem v odmerku 18/3 mg/kg dvakrat na dan ali po odmerni shemi za odrasle) in 40 bolnikov, starih od 12 do 18 let (večina je bila zdravljena po odmerni shemi za odrasle).
English: AUC ↓ 16% (-36%; +8%) Cmin ↓ 19% (-42%; +13%)
Slovenian: Cmax  14% (- 36%; + 15%) AUC  16% (- 36%; + 8%) Cmin  19% (- 42%; + 13%)
English: The relevance of the hepatocellular findings in the rodents for humans is uncertain; however, there is no evidence from clinical trials or marketed use to suggest that these findings are of clinical significance.
Slovenian: Pomen sprememb na jetrnih celicah pri glodalcih za človeka ni pojasnjen, vendar pa med kliničnimi preskušanji ali med uporabo zdravila po pridobitvi dovoljenja za promet ni bilo znakov, ki bi kazali, da imajo te ugotovitve klinični pomen.
English: Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products.
Slovenian: Zdravilo Telzir je v kombinaciji z nizkim odmerkom ritonavirja in v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje odraslih, mladostnikov in otrok, starih 6 let in več, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1).
English: (CYP3A4 induction by rifampicin)
Slovenian: (indukcija CYP3A4 z rifampicinom)
English: The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Slovenian: Priporočeni odmerek je 14 ml zdravila Telzir peroralna suspenzija (700 mg fosamprenavirja) dvakrat na dan z 100 mg ritonavirja (v obliki kapsul ali peroralne suspenzije) dvakrat na dan.
English: LPV/RTV BID (N=103)
Slovenian: LPV/RTV 2x/dan (N=103)
English: Anti-fungals:
Slovenian: Antimikotiki:
English: (Mixed CYP3A4 induction/inhibition)
Slovenian: (mešana CYP3A4 indukcija/inhibicija)
English: In a randomised open-label study (ESS100732 - KLEAN) in antiretroviral naïve patients, fosamprenavir (700 mg) co-administered with low dose ritonavir (100 mg) in a twice daily regimen including abacavir / lamivudine (600 mg / 300 mg) fixed dose combination tablet once daily showed comparable efficacy over 48 weeks to lopinavir / ritonavir (400 mg / 100 mg) given twice daily in combination with abacavir / lamivudine (600 mg / 300 mg once daily).
Slovenian: Pri randomizirani, odprti študiji (ESS100732-KLEAN), ki so jo izvedli pri bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, je bila učinkovitost zdravljenja s fosamprenavirjem (700 mg) skupaj z nizkim odmerkom ritonavirja (100 mg) dvakrat na dan in kombinacijo abakavir/lamivudin (600 mg/300 mg) v fiksnem odmerku v obliki tablete enkrat na dan po 48 tednih primerljiva z učinkovitostjo zdravljenja s kombinacijo lopinavir/ritonavir (400 mg/100 mg) dvakrat na dan skupaj s kombinacijo abakavir/lamivudin (600 mg/300 mg enkrat na dan).
English: Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe.
Slovenian: Postopna navodila V plastenki ali odmerni brizgi zdravila Telzir ne smete mešati z nobenim drugim zdravilom.
English: Paediatrics
Slovenian: Pediatrija
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SUSPENSION
Slovenian: NALEPKA ZA PLASTENKO S PERORALNO SUSPENZIJO
English: (CYP induction by FPV/RTV)
Slovenian: (indukcija CYP z FPV/RTV)
English: Children 6 to 11 years of age (n=9) receiving fosamprenavir / ritonavir 18 / 3 mg/kg twice daily had 26 % higher AUC(0-24) and similar Cmax and Cmin values when compared to the historical adult population receiving fosamprenavir / ritonavir 700 / 100 mg twice daily.
Slovenian: Bolniki, stari od 6 do 11 let (n=9), ki so prejemali fosamprenavir/ritonavir 18/3 mg/kg dvakrat na dan, so imeli za 26 % višje plazemske koncentracije APV (AUC(0-24)) in podobne Cmax in Cmin vrednosti kot odrasla populacija, ki je prejemala fosamprenavir/ritonavir 700/100 mg dvakrat na dan.
English: The
Slovenian: a a
English: In the studies of PI-experienced adult patients, APV30003 and its extension, APV30005 (fosamprenavir 700 mg / ritonavir 100 mg twice daily: n=107), the following mutations emerged in patients experiencing virological failure through 96 weeks: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V, and L90M.
Slovenian: V študiji pri odraslih bolnikih, ki so se predhodno že zdravili z zaviralci proteaz, APV30003 in njenem podaljšku APV30005 (fosamprenavir 700 mg / ritonavir 100 mg dvakrat na dan: n = 107), so se pri bolnikih z virusnim neodzivom med 96 tedni zdravljenja pojavile naslednje mutacije: L10F/I, L24I, V32I, L33F, M36I, M46I/L, I47V, I50V, I54L/M/S, A71I/T/V, G73S, V82A, I84V in L90M.
English: Blood cholesterol increased Very common Blood triglycerides increased Common Alanine aminotransferase increased
Slovenian: Preiskave zvišanje holesterola v krvi zvišanje trigliceridov v krvi zvišanje alaninaminotransferaze zelo pogosti pogosti pogosti zvišanje aspartataminotransferaze pogosti zvišanje lipaze pogosti
English: Warfarin Other oral anticoagulants
Slovenian: varfarin drugi peroralni antitrombotiki
English: Telzir will not stop you passing on HIV.
Slovenian: Zdravilo Telzir ne more preprečiti širjenja okužbe z virusom HIV.
English: Fosamprenavir was not mutagenic or genotoxic in a standard battery of in vitro and in vivo assays.
Slovenian: V običajnih in vitro in in vivo testih fosamprenavir ni kazal mutagenega ali genotoksičnega delovanja.
English: Amprenavir: Cmax ↔* Amprenavir: AUC ↔* Amprenavir: Cmin ↔* * compared to historical data
Slovenian: amprenavir: Cmax * amprenavir: AUC * amprenavir: Cmin * * primerjava s preteklimi podatki
English: Bottle with 225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
Slovenian: Plastenka z 225 ml peroralne suspenzije V škatlici je priložena tudi 10 ml umerjena odmerna brizga in nastavek.
English: Remove the bottle cap and keep it safely.
Slovenian: Pokrovček varno shranite.
English: Don't stop unless your doctor advises you to.
Slovenian: Zdravila ne nehajte jemati, ne da bi vam tako svetoval zdravnik.
English: Atorvastatin: Cmax ↑ 184% Atorvastatin: AUC ↑ 153% Atorvastatin: Cmin ↑ 73%
Slovenian: atorvastatin 10 mg enkrat dnevno 4 dni atorvastatin: Cmax  184% atorvastatin: AUC  153% atorvastatin: Cmin  73%
English: Telzir 50 mg/ml oral suspension
Slovenian: Telzir 50 mg/ml peroralna suspenzija
English: Anti-fungals: Ketoconazole
Slovenian: ketokonazol
English: Compared to the historical adult population receiving fosamprenavir with ritonavir 700 mg / 100 mg twice daily, a subset of five pediatric subjects ages 6 to < 24-months receiving fosamprenavir / ritonavir 45/7 mg/kg twice daily demonstrated that despite an approximate 5-fold increase in fosamprenavir and ritonavir doses on a mg/kg basis, plasma amprenavir AUC(0-τ) was approximately 48 % lower, Cmax 26 % lower, and Cτ 29 % lower in the paediatric subjects.
Slovenian: Primerjava s prejšnjo odraslo populacijo, ki je prejemala fosamprenavir/ritonavir 700/100 mg dvakrat na dan, je pokazala, da je v podskupini bolnikov, starih od 6 od 24 mesecev, ki je dobivala fosamprenavir/ritonavir v odmerku 45/7 mg/kg na dan, kljub približno 5-kratnemu porastu odmerkov fosamprenavirja in ritonavirja, preračunano na kg telesne mase, pri pediatričnih bolnikih plazemska koncentracija amprenavirja pod krivuljo AUC(0-τ) padla za približno 48 %, Cmax je bila za 26 % nižja in Cτ za 29 % nižja.
English: A 10 ml graduated dosing syringe and an adapter are also included in the pack.
Slovenian: V škatlici je priložena tudi 10 ml umerjena odmerna brizga in nastavek.
English: Tabulated summary of adverse reactions
Slovenian: Prikaz povzetka neželenih učinkov v preglednici
English: Please refer to the table below for the dosing recommendations in paediatric patients.
Slovenian: Priporočila za odmerjanje pri pediatričnih bolnikih so prikazana v spodnji preglednici.
English: Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking Telzir due to the risk of decreased plasma concentrations and reduced clinical effects of amprenavir (see section 4.5).
Slovenian: Pripravki rastlinskega izvora s šentjanževko (Hypericum perforatum) se zaradi nevarnosti znižanja plazemskih koncentracij in manjše klinične učinkovitosti amprenavirja ne smejo uporabljati sočasno z zdravilom Telzir (glejte poglavje 4.5).
English: You may still develop other infections and illnesses linked to HIV infection.
Slovenian: Da bolezen ne bo napredovala, morate zdravilo jemati vsak dan. Še vedno pa se lahko pojavijo druge okužbe in bolezni, ki so povezane z okužbo z virusom HIV.
English: Phenotypic resistance testing
Slovenian: Fenotipsko testiranje rezistence
English: In a randomised open-label study (APV30003) in protease inhibitor experienced patients with virological failure (less than or equal to two PIs) the fosamprenavir with ritonavir combination (700 / 100 mg twice daily or 1400 / 200 mg once daily) did not demonstrate non-inferiority to lopinavir / ritonavir with regard to viral suppression as measured by the average area under the curve minus baseline (AAUCMB) for plasma HIV-1 RNA over 48 weeks (the primary end point).
Slovenian: V randomizirani odprti študiji (APV30003) pri z zaviralci proteaz predhodno že zdravljenih bolnikih, pri katerih je prišlo do virološkega neuspeha (z dvema PI ali manj), se je izkazalo, da kombinacija fosamprenavir z ritonavirjem (700 mg/100 mg dvakrat dnevno ali 1.400 mg/200 mg enkrat dnevno) ni manj učinkovita od kombinacije lopinavir/ritonavir, upoštevaje supresijo virusa z merjenjem povprečne površine pod krivuljo zmanjšane za izhodiščne vrednosti (AAUCMB) HIV-1 RNA v plazmi tekom 48 tednov (primarni opazovani dogodek).
English: Co-administration of ritonavir with fosamprenavir increase plasma amprenavir AUC by approximately 2-fold and plasma Cτ,ss by 4- to 6-fold, compared to values obtained when fosamprenavir is administered alone.
Slovenian: V primerjavi z uporabo fosamprenavirja samega se pri uporabi ritonavirja skupaj s fosamprenavirjem plazemska AUC amprenavirja poveča za približno 2-krat, plazemska C,ss pa za 4- do 6-krat.
English: Adult years)
Slovenian: Odrasli (>18 let)
English: These may affect up to 1 in 1000 people:
Slovenian: Neželeni učinki, ki se lahko pojavijo pri do 1 od 1.000 bolnikov:
English: ≤ 200 mg once daily
Slovenian: metadon ≤ 200 mg enkrat dnevno
English: Non-nucleoside reverse transcriptase inhibitors:
Slovenian: Nenukleozidni zaviralci reverzne transkriptaze:
English: Table 1 Efficacy Outcome at Week 48 in ESS100732 (ART-Naïve Patients)
Slovenian: Preglednica 1: Rezultati učinkovitosti v 48. tednu pri študiji ESS100732 (bolniki, ki predhodno še niso bili zdravljeni s protiretrovirusnimi zdravili)
English: Proportion with HIV-1 RNA < 50 copies/ml
Slovenian: Razmerje s HIV-1 RNA < 50 kopij/ml
English: Placental transfer of amprenavir has been shown to occur in humans.
Slovenian: Pri ljudeh je bil dokazan prenos amprenavirja skozi placento.
English: • , , simeprevir, daclatasvir (used to treat hepatitis C virus infection)
Slovenian: • simeprevir, daklatasvir (uporabljamo jih za zdravljenje okužbe z virusom hepatitisa C)
English: Maraviroc: AUC12 ↑ 2.49 Maraviroc: Cmax ↑ 1.52
Slovenian: 300 mg dvakrat dnevno maravirok: AUC12  2.49 maravirok: Cmax  1.52 maravirok: C12  4,74
English: When ART naïve adult patients were treated with the currently approved doses of fosamprenavir/ritonavir, as for other ritonavir boosted PI regimens, the mutations described were infrequently observed.
Slovenian: Pri odraslih bolnikih, ki se predhodno še niso zdravili s protiretrovirusnimi zdravili, so se pri zdravljenju s trenutno priporočenimi odmerki fosamprenavirja/ritonavirja opisane mutacije pojavile redko, podobno kot pri drugih režimih zdravljenja z zaviralci proteaz z okrepitvijo z ritonavirjem.
English: Your doctor will monitor your blood glucose levels before and during treatment with Telzir.
Slovenian: Pred in med zdravljenjem z zdravilom Telzir bo vaš zdravnik kontroliral vrednosti sladkorja v krvi.
English: Norethisterone: Cmax ↓ 38% Norethisterone: AUC ↓ 34% Norethisterone: Cmin ↓ 26
Slovenian: noretisteron: Cmax  38% noretisteron: AUC  34% noretisteron: Cmin  26
English: AUC ↓ 55% (-76%; -16%) Cmin ↓ 36 % (-57%; -3%)
Slovenian: Cmax  51% (- 75%; - 3%) AUC  55% (- 76%; - 16%) Cmin  36 % (- 57%; - 3%)
English: Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients listed in section
Slovenian: Preobčutljivost na fosamprenavir, amprenavir, ritonavir ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: Lurasidone: ↑ expected (CYP3A4 inhibition)
Slovenian: lurazidon:  pričakovano (inhibicija CYP3A4)
English: Proportion with HIV-1 RNA < 400 copies/ml
Slovenian: Razmerje s HIV-1 RNA < 400 kopij/ml
English: Amprenavir: Cmax ↓ 13%* Amprenavir: AUC ↓ 26%* Amprenavir: Cmin ↓ 42 %* * compared to fosamprenavir / ritonavir 700 mg/100 mg twice daily
Slovenian: amprenavir: AUC  26%* amprenavir: Cmin  42 %* * primerjava s fosamprenavir/ritonavir 700 mg/100 mg dvakrat dnevno
English: Despite reducing the dosing frequency of ritonavir, subjects with severe hepatic impairment had 64% higher ritonavir Cmax, 40% higher ritonavir AUC(0-24), and 38% higher ritonavir C12 than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Slovenian: Kljub manj pogosti uporabi ritonavirja so imele osebe s hudo okvaro jeter 64 % večjo Cmax ritonavirja, 40 % večjo AUC(0-24) ritonavirja in 38 % večjo C12 ritonavirja kot osebe z normalnim delovanjem jeter, ki so dobile standardno shemo fosamprenavirja z ritonavirjem 700 mg/100 mg dvakrat na dan.
English: No dose separation or dosage adjustment necessary (see Antacids).
Slovenian: Odmerkov ni potrebno ločevati ali prilagajati.
English: Sixteen of 434 ART-naïve patients who received fosamprenavir 700 mg/ritonavir 100 mg twice daily in ESS100732 experienced virological failure by Week 48 with 14 isolates genotyped.
Slovenian: 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.
English: Amprenavir: ↓ expected (Modest CYP3A4 induction)
Slovenian: amprenavir:  pričakovano (zmerna indukcija CYP3A4)
English: PHARMACEUTICAL FORM Oral suspension
Slovenian: peroralna suspenzija
English: In addition, decreased number of implantation sites per litter and a prolongation of gestation were seen when pups were mated after reaching maturity.
Slovenian: Po doseženi spolni starosti je bilo pri takšnih mladičih ugotovljeno manjše število implantacijskih mest in podaljšanje obdobja gestacije.
English: Oral use Read the package leaflet before use
Slovenian: Pred uporabo natančno preberite navodilo!
English: The recommended dose is 700 mg fosamprenavir twice daily with 100 mg ritonavir twice daily.
Slovenian: Priporočen odmerek je fosamprenavir v odmerku 700 mg dvakrat dnevno skupaj z ritonavirjem v odmerku 100 mg dvakrat dnevno.
English: Oral suspension should be taken with food <25 kg No dosing recommendations
Slovenian: <25 kg Za odmerjanje ni priporočil
English: Microcrystalline cellulose Croscarmellose sodium Povidone K30
Slovenian: Jedro tablete: mikrokristalna celuloza premreženi natrijev karmelozat povidon K30 magnezijev stearat brezvodni koloidni silicijev dioksid
English: Examples of antineoplastic agents: dasatinib nilotinib ibrutinib vinblastine everolimus
Slovenian: ANTINEOPLASTIČNE UČINKOVINE, KI SE METABOLIZIRAJO S CYP3A Primeri antineoplastičnih učinkovin: dasatinib nilotinib ibrutinib vinblastin everolimus
English: (Mixed CYP3A4 induction/inhibition, Pgp induction)
Slovenian: (mešana indukcija/inhibicija CYP3A4 , indukcija Pgp)
English: If you get any side effects →Talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: The benefit in this age group has mainly been derived from study APV29005, an open label 48 week study evaluating the pharmacokinetic profiles, safety, and antiviral activity of fosamprenavir with ritonavir administered twice daily to HIV 1 protease inhibitor experienced and naive patients 2 to 18 years of age.
Slovenian: APV29005 je odprta 48-tedenska študija, ki bo ovrednotila farmakokinetični profil, varnost in protivirusno učinkovitost fosamprenavirja skupaj z ritonavirjem, danim dvakrat na dan bolnikom, starim od 2 do 18 let, ki so že bili zdravljeni z zaviralci HIV-1 proteaze in takšnim, ki z njimi še niso bili zdravljeni.
English: Lopinavir: Cmax ↔* Lopinavir: AUC ↔* Lopinavir: Cmin ↔* * compared to lopinavir / ritonavir 400 mg/100 mg twice daily
Slovenian: lopinavir: Cmax * lopinavir: AUC * lopinavir: Cmin * * primerjava z lopinavir/ritonavir 400 mg/100 mg dvakrat dnevno amprenavir: Cmax  13%*
English: NAME OF THE MEDICINAL PRODUCT Telzir 700 mg film-coated tablets
Slovenian: Telzir 700 mg filmsko obložene tablete
English: Dolutegravir 50 mg once daily
Slovenian: dolutegravir 50 mg enkrat dnevno dolutegravir
English: FPV/RTV 700 mg/100 mg BID (n= 434)
Slovenian: FPV/RTV 700 mg/100 mg 2x/dan (n= 434)
English: Blood cholesterol increased Blood triglycerides increased Alanine aminotransferase increased
Slovenian: Preiskave zvišanje holesterola v krvi zvišanje trigliceridov v krvi zvišanje alaninaminotransferaze zvišanje aspartataminotransferaze zvišanje lipaze zelo pogosti pogosti pogosti pogosti pogosti
English: Adults The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily.
Slovenian: Priporočeni odmerek je ena 700-mg tableta zdravila Telzir dvakrat na dan s 100 mg ritonavirja dvakrat na dan.
English: Telzir may be less effective due to decreased amprenavir plasma concentrations in patients taking these medicinal products concomitantly (see section 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo omenjena zdravila, je zaradi manjših plazemskih koncentracij amprenavirja, učinkovitost zdravila Telzir lahko manjša (glejte poglavje 4.5).
English: Phenytoin: Cmax ↓ 20% Phenytoin: AUC ↓ 22% Phenytoin: Cmin ↓ 29%
Slovenian: fenitoin 300 mg enkrat dnevno fenitoin: Cmax  20% fenitoin: AUC  22% fenitoin: Cmin  29%
English: How to store Telzir
Slovenian: Shranjevanje zdravila Telzir
English: Fosamprenavir with ritonavir was generally well-tolerated in subjects with mild, moderate, or severe hepatic impairment, and these regimens had similar adverse event and clinical laboratory profiles as previous studies of HIV-1 infected subjects with normal hepatic function.
Slovenian: Pri tem režimu odmerjanja sta bila profila neželenih učinkov in kliničnih laboratorijskih vrednosti podobna kot pri predhodnih študijah, izvedenih pri z virusom HIV-1 okuženih osebah z normalnim delovanjem jeter.
English: CSF penetration of amprenavir is negligible in humans.
Slovenian: Pri ljudeh je prehajanje amprenavirja v cerebrospinalno tekočino zanemarljivo.
English: LPV/RTV 400 mg/100 mg BID (n=444)
Slovenian: LPV/RTV 400 mg/100 mg 2x/dan (n=444)
English: Propafenone: ↑ expected (CYP2D6 inhibition by RTV)
Slovenian: flekainide:  pričakovano propafenon:  pričakovano (inhibicija CYP2D6 z RTV)
English: Ritonavir: Cmax ↑ 63%* Ritonavir: AUC ↑ 45%* * compared to historical data
Slovenian: Amprenavir: Cmax * Amprenavir: AUC * Amprenavir: Cmin * * primerjava s preteklimi podatki ritonavir: Cmax  63%* ritonavir: AUC  45%* * primerjava s preteklimi podatki
English: Please refer to the table below for the dosing recommendations in adults.
Slovenian: Priporočila za odmerjanje pri odraslih so prikazana v spodnji preglednici.
English: These may affect up to 1 in 100 people:
Slovenian: Neželeni učinki, ki se lahko pojavijo pri do 1 od 100 bolnikov:
English: Caution is advised if the recommended doses of Telzir with ritonavir detailed below are exceeded (see section 4.4).
Slovenian: V primeru prekoračitve spodaj navedenih priporočenih odmerkov zdravila Telzir v kombinaciji z ritonavirjem je potrebna previdnost (glejte poglavje 4.4).
English: • Headache, feeling dizzy
Slovenian: • Glavobol, omotica.
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Therapeutic concentration monitoring is recommended for immunosuppressant medicinal products (cyclosporine, tacrolimus, rapamycin) when co-administered with Telzir (see section 4.5).
Slovenian: Če se zdravila za zaviranje imunske odzivnosti (ciklosporin, takrolimus, rapamicin) dajejo sočasno z zdravilom Telzir, je priporočljivo nadzirati njihove terapevtske koncentracije (glejte poglavje 4.5).