FrancophonIA/ELRC3.0 huggingface dataset:
English: Saquinavir AUC0-12 ↓ 13% (90% CI: 31↓ - 9↑) Saquinavir Cmax ↓ 15% (90% CI: 32↓ - 7↑) Ritonavir AUC0-12 ↔ (90% CI: 10↓ - 9↑) Ritonavir Cmax ↔ (90% CI: 8↓ - 7↑)
Croatian: Sakvinavir AUC0-12 ↓ 13% (90% CI: 31↓ - 9↑) Sakvinavir Cmax ↓ 15% (90% CI: 32↓ - 7↑) Ritonavir AUC0-12 ↔ (90% CI: 10↓ - 9↑) Ritonavir Cmax ↔ (90% CI: 8↓ - 7↑)
English: Saquinavir AUC ↑ 99 % Saquinavir Cmax ↑ 106 %
Croatian: - Sakvinavir AUC ↑ 99% Sakvinavir Cmax ↑ 106%
English: The corresponding serum (50% human serum) adjusted EC50 ranged from 25-250 nM. Clinical isolates of HIV-2 demonstrated EC50 values in the range of 0.3-2.4 nM.
Croatian: Odgovarajuće vrijednosti EC50 prilagođene za serum (50% humani serum) kretale su se u rasponu od 25 do 250 nM.
English: After 7 days, the recommended dose of Invirase is 1000 mg two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Croatian: Nakon 7 dana preporučena doza lijeka Invirase je 1000 mg dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan, u kombinaciji s drugim antiretrovirusnim lijekovima.
English: No dose adjustment of saquinavir recommended.
Croatian: Ne preporučuje se prilagodba doze sakvinavira.
English: Caution should be exercised when Invirase/ritonavir and digoxin are coadministered.
Croatian: Potreban je oprez kad se lijekovi Invirase/ritonavir primjenjuju istodobno s digoksinom.
English: If the combination is considered necessary, monitoring of the saquinavir plasma levels is strongly encouraged (see section
Croatian: Ako se ta kombinacija ipak smatra nužnom, izrazito se preporučuje nadzor koncentracija sakvinavira u plazmi (vidjeti dio 4.4).
English: In vitro studies have shown that saquinavir is a substrate for P-glycoprotein (P-gp).
Croatian: Ispitivanja in vitro pokazala su da je sakvinavir supstrat P-glikoproteina (P-gp).
English: Therefore, the co-administration of boosted saquinavir and tipranavir, co-administered with low dose ritonavir, is not recommended.
Croatian: Stoga se ne preporučuje istodobna primjena pojačanog sakvinavira i tipranavira uz nisku dozu ritonavira.
English: Concomitant administration of tipranavir, co-administered with low dose ritonavir, with saquinavir/ritonavir, is not recommended.
Croatian: Istodobna primjena tipranavira s malom dozom ritonavira u kombinaciji sa sakvinavirom/ritonavirom se ne preporučuje.
English: Due to CYP3A inhibition by saquinavir/ritonavir, concentrations of quetiapine are expected to increase.
Croatian: Zbog inhibicije CYP3A uzrokovane sakvinavirom/ritonavirom, očekuje se porast koncentracije kvetiapina.
English: Invirase comes as a 500 mg film-coated tablet.
Croatian: Invirase dolazi u obliku filmom obloženih tableta od 500 mg.
English: There is limited experience of overdose with saquinavir.
Croatian: Iskustvo s predoziranjem sakvinavirom je ograničeno.
English: Sildenafil Cmax ↑ 140 % Sildenafil AUC ↑ 210 %
Croatian: - Sakvinavir ↔ Sildenafil Cmax ↑ 140% Sildenafil AUC ↑ 210% - Sildenafil je supstrat CYP3A4.
English: Rifampicin is contraindicated in combination with Invirase/ritonavir (see section 4.3).
Croatian: Rifampicin je kontraindiciran u kombinaciji s lijekovima Invirase/ritonavir (vidjeti dio 4.3).
English: The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated tablets) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents.
Croatian: Preporučena doza lijeka Invirase je 1000 mg (2 x 500 mg filmom obložene tablete) dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan, u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Concentrations of bepridil, systemic lidocaine, quinidine or hydroquinidine may be increased when co-administered with Invirase/ritonavir.
Croatian: Koncentracije bepridila, sistemskog lidokaina, kinidina i hidrokinidina mogu se povisiti ako se primjenjuju istodobno s lijekovima Invirase/ritonavir.
English: Due to CYP3A inhibition by saquinavir/ritonavir, concentrations of lurasidone are expected to increase.
Croatian: Zbog inhibicije CYP3A uzrokovane sakvinavirom/ritonavirom očekuje se porast koncentracije lurasidona.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Njemačka
English: Concomitant use of ritonavir-boosted Invirase with other medicinal products that prolong the QT and/or PR interval is therefore contraindicated (see section 4.3).
Croatian: Stoga je kontraindicirana istodobna primjena lijeka Invirase pojačanog ritonavirom s drugim lijekovima koji produljuju QT i/ili PR-interval (vidjeti dio 4.3).
English: Following the modified Invirase/ritonavir regimen, saquinavir exposure during the first week peaked on Day 3 and declined to the lowest exposure on Day 7 with ritonavir induction effects, while Day 14 saquinavir PK parameters (following full doses of Invirase/ritonavir in the second week) approached the range of historical mean values for saquinavir steady-state values in HIV-1 infected patients (Table 9).
Croatian: Nakon primjene modificiranog režima doziranja lijekova Invirase/ritonavir, izloženost sakvinaviru tijekom prvih tjedan dana postigla je vršnu vrijednost 3. dana liječenja te je uz indukcijske učinke ritonavira pala na najnižu vrijednost 7. dana, dok su farmakokinetički parametri sakvinavira 14. dana (nakon primjene punih doza lijekova Invirase/ritonavir u drugom tjednu liječenja) dosegli raspon srednjih vrijednosti zabilježen u prethodnim ispitivanjima za sakvinavir u stanju dinamičke ravnoteže u bolesnika s HIV-1 infekcijom (Tablica 9).
English: • various steroids - such as dexamethasone, ethinyl estradiol, fluticasone
Croatian: • različite steroide, poput deksametazona, etinilestradiola, flutikazona
English: The most frequently (in more than ten in a hundred persons) reported side effects of saquinavir taken with ritonavir concern the gastrointestinal tract, with feeling sick, diarrhoea, tiredness, vomiting, wind and abdominal pain being the most common.
Croatian: Najčešće prijavljene (u više od deset na stotinu osoba) nuspojave sakvinavira koji se uzima s ritonavirom odnose se na probavni sustav, a najčešće su: mučnina, proljev, umor, povraćanje, vjetrovi i bol u trbuhu.
English: No clinically significant alterations of either saquinavir or efavirenz concentration were noted in studies in healthy volunteers or in HIVinfected patients (see section 4.5).
Croatian: U ispitivanjima sa zdravim dobrovoljcima i bolesnicima zaraženima HIV-om nisu opažene klinički značajne promjene koncentracija sakvinavira ni efavirenza (vidjeti dio 4.5).
English: Lopinavir/ritonavir 400/100 mg bid (saquinavir 1000 mg bid in combination with 2 or 3 NRTIs)
Croatian: Lopinavir/ritonavir 400/100 mg dvaput na dan (sakvinavir 1000 mg dvaput na dan u kombinaciji sa dva ili tri NRTI-ja)
English: In the therapeutic and the supra-therapeutic arm 11% and 18% of subjects, respectively, had a QTcS between 450 and 480 msec.
Croatian: U skupini koja je primala terapijske doze 11% ispitanika imalo je QTcS-interval između 450 i 480 ms, a u skupini koja je primala supraterapijske doze 18% ispitanika.
English: For treatment-naive patients initiating treatment with Invirase/ritonavir, the starting recommended dose of Invirase is 500 mg (1 x 500 mg film-coated tablet) two times daily with ritonavir 100 mg two times daily in combination with other antiretroviral agents for the first 7 days of treatment.
Croatian: Za prethodno neliječene bolesnike koji započinju liječenje lijekovima Invirase/ritonavir početna preporučena doza lijeka Invirase je 500 mg (1 x 500 mg filmom obložena tableta) dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan, u kombinaciji s drugim antiretrovirusnim lijekovima u prvih 7 dana liječenja.
English: No dose adjustment required for Invirase/ritonavir.
Croatian: Nije potrebna prilagodba doze lijekova Invirase/ritonavir.
English: Renal impairment: Renal clearance is only a minor elimination pathway, the principal route of metabolism and excretion for saquinavir being via the liver.
Croatian: Oštećenje bubrežne funkcije: Samo se malen dio sakvinavira iz tijela eliminira putem bubrega, dok je glavni put metaboliziranja i izlučivanja jetra.
English: Antidepressants Tricyclic antidepressants (e.g. amitriptyline, imipramine, clomipramine) (saquinavir/ritonavir)
Croatian: Antidepresivi Triciklički antidepresivi (npr. amitriptilin, imipramin, klomipramin) (sakvinavir/ritonavir)
English: Midazolam AUC ↑ 12.4 fold Midazolam Cmax ↑ 4.3 fold Midazolam t1/2 ↑ from 4.7 h to 14.9 h
Croatian: Midazolam AUC ↑ 12,4 puta Midazolam Cmax ↑ 4,3 puta Midazolam t1/2 ↑ sa 4,7 h na 14,9 h Nema podataka o istodobnoj primjeni sakvinavira pojačanog ritonavirom s intravenski primijenjenim midazolamom.
English: • certain medicines that may be used for a variety of things: cisapride, diphemanil, mizolastine,
Croatian: • nekih lijekova koji se mogu koristiti za različita stanja: cisaprid, difemanil, mizolastin, kinin, vinkamin
English: Monitoring of saquinavir plasma concentration is recommended (see section 4.4).
Croatian: Preporučuje se nadzirati koncentraciju sakvinavira u plazmi (vidjeti dio 4.4).
English: On Day 3, the upper 1-sided 95% confidence interval of the maximum mean difference in pre-dose baseline-corrected QTcS (study specific heart rate corrected QT) between the active drug and placebo arms was > 10 msec for the two ritonavir-boosted Invirase treatment groups (see results in Table 3).
Croatian: Trećega je dana gornji jednostrani 95%-tni interval pouzdanosti najviše prosječne razlike u QTcS-intervalu (za studiju specifični QT-interval, korigiran prema srčanoj frekvenciji), korigiranom u odnosu na početno stanje prije prve doze, između skupina koje su primale djelatnu tvar odnosno placebo iznosio > 10 ms u obje skupine koje su primale Invirase uz potpornu terapiju ritonavirom (vidjeti rezultate u Tablici 3).
English: - Nevirapine (unboosted saquinavir)
Croatian: - Nevirapin (nepojačani sakvinavir)
English: Saquinavir AUC ↓ 30% Saquinavir Cmax ↓ 25% Saquinavir Cmin ↔
Croatian: Sakvinavir AUC ↓ 30% Sakvinavir Cmax ↓ 25% Sakvinavir Cmin ↔
English: Rifabutin 150 mg q3d (saquinavir/ritonavir 1000/100 mg bid) in healthy volunteers
Croatian: Rifabutin 150 mg svaki treći dan (sakvinavir/ritonavir 1000/100 mg dvaput na dan) u zdravih dobrovoljaca
English: Invirase/ritonavir and ergot alkaloids is contra-indicated (see section 4.3).
Croatian: Istodobna primjena lijekova Invirase/ritonavira i ergot alkaloida je kontraindicirana (vidjeti dio 4.3).
English: In HIV-infected patients, Invirase or saquinavir soft capsules in combination with ritonavir at doses of 1000/100 mg twice daily provide a systemic exposure of saquinavir over a 24 hour period similar to or greater than that achieved with saquinavir soft capsules 1200 mg three times daily (see section 5.2).
Croatian: U bolesnika zaraženih HIV-om Invirase ili meke kapsule sakvinavira u kombinaciji s ritonavirom u dozama od 1000/100 mg dvaput na dan dovode do sustavne izloženosti sakvinaviru tijekom 24 sata koje je slično onome postignutom uz meke kapsule sakvinavira u dozi od 1200 mg triput na dan ili veće (vidjeti dio 5.2).
English: - Indinavir 800 mg tid (saquinavir 600-1200 mg single dose)
Croatian: - Indinavir 800 mg triput na dan (sakvinavir u jednokratnoj dozi od 600-1200 mg)
English: Therefore, concomitant use of ritonavir-boosted Invirase with other medicinal products that prolong the QT and/or PR interval is contraindicated.
Croatian: Stoga je kontraindicirana istodobna primjena lijeka Invirase pojačanog ritonavirom s drugim lijekovima koji produljuju QT i/ili PR-interval.
English: Itraconazole is a moderately potent inhibitor of CYP3A4.
Croatian: Itrakonazol je umjereno jak inhibitor CYP3A4.
English: Anticonvulsants - Carbamazepine Phenobarbital Phenytoin (saquinavir/ritonavir)
Croatian: Antikonvulzivi - Karbamazepin Fenobarbital Fenitoin (sakvinavir/ritonavir)
English: No clinical data available for the combination of saquinavir/ritonavir 1000/100 mg bid and atazanavir.
Croatian: Nisu dostupni klinički podaci za kombinaciju sakvinavira/ritonavira 1000/100 mg dvaput na dan s atazanavirom.
English: Invirase/ritonavir is contraindicated in patients with decompensated liver disease (see section 4.3).
Croatian: Invirase/ritonavir su kontraindicirani u bolesnika s dekompenziranom bolešću jetre (vidjeti dio 4.3).
English: hydroquinidine, ibutilide, lidocaine, propafenone, quinidine, sotalol
Croatian: flekainida, hidrokinidina, ibutilida, lidokaina, propafenona, kinidina, sotalola
English: Each film-coated tablet contains lactose (monohydrate) 38.5 mg.
Croatian: Jedna filmom obložena tableta sadrži 38,5 mg laktoze hidrata.
English: All but one of the patients achieved Ctrough values of saquinavir above the therapeutic threshold (100 ng/ml) in the fasted state.
Croatian: Svi osim jednog bolesnika su nakon uzimanja lijeka natašte dostigli Ctrough sakvinavira iznad terapijskog praga (100 ng/ml).
English: Saquinavir AUC ↓ 1% Saquinavir Cmax ↓ 7% Saquinavir Cmin ↔
Croatian: Sakvinavir AUC ↓ 1% Sakvinavir Cmax ↓ 7% Sakvinavir Cmin ↔
English: The effect of treatment initiation with a dosing regimen of Invirase/ritonavir 500 /100 mg twice daily in combination with 2 NRTIs for the first 7 days of treatment followed by Invirase/ritonavir 1000 / 100 mg twice daily in combination with 2 NRTIs in the subsequent 7 days on QTc interval, PK, and viral load was evaluated in an open-label 2-week observational study in 23 HIV-1 infected, treatmentnaïve patients initiating Invirase/ritonavir therapy.
Croatian: Učinak započinjanja liječenja lijekovima Invirase/ritonavir režimom doziranja od 500/100 mg dvaput na dan u kombinaciji s 2 NRTI-ja tijekom prvih 7 dana liječenja, nakon kojih slijedi 7 dana liječenja lijekovima Invirase/ritonavir u dozi od 1000/100 mg dvaput na dan u kombinaciji s 2 NRTI-ja, na QTc-interval, farmakokinetiku i virusno opterećenje ocijenjen je u 2-tjednom otvorenom opservacijskom ispitivanju u 23 prethodno neliječena bolesnika s HIV-1 infekcijom koji su započinjali liječenje lijekovima Invirase/ritonavir.
English: Only 2/21 (9%) patients across all study days had maximum QTcF change from dense predose baseline ≥ 30 ms following administration of the modified Invirase/ritonavir regimen in the treatment-naïve HIV-1 infected patient population; and the maximum mean change from dense predose baseline in QTcF was < 10 ms across all study days.
Croatian: U populaciji prethodno neliječenih bolesnika s HIV-1 infekcijom samo su 2/21 (9%) bolesnika tijekom svih dana ispitivanja imala maksimalnu promjenu QTcF u odnosu na prosječnu uzastopnu početnu vrijednost prije doziranja od ≥ 30 ms nakon primjene modificiranog režima doziranja lijekova Invirase/ritonavir; maksimalna srednja promjena QTcF u odnosu na prosječnu uzastopnu početnu vrijednost prije doziranja bila je < 10 ms tijekom svih dana ispitivanja.
English: Therefore, no initial dose adjustment is necessary for patients with renal impairment.
Croatian: Stoga, nije potrebna prilagodba početne doze u bolesnika s oštećenjem bubrežne funkcije.
English: • medicines used to treat asthma or other chest illness such as Chronic Obstructive Pulmonary
Croatian: • lijekove za liječenje astme ili drugih prsnih bolesti, primjerice kronične opstruktivne bolesti pluća (KOBP), poput salmeterola
English: 79639 Grenzach-Wyhlen Germany
Croatian: 1, 79639 Grenzach-Wyhlen, Njemačka.
English: In the MaxCmin1 study, the safety and efficacy of saquinavir soft capsules/ritonavir 1000/100 mg twice daily plus 2 NRTIs/Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) was compared to indinavir/ritonavir 800/100 mg twice daily plus 2 NRTIs/NNRTIs in over 300 (both protease inhibitor treatment naïve and experienced) subjects.
Croatian: U ispitivanju MaxCmin1 uspoređena je sigurnost i djelotvornost mekih kapsula sakvinavira/ritonavira u dozi od 1000/100 mg dvaput na dan uz dva NRTI-ja/nenukleozidna inhibitora reverzne transkriptaze (NNRTI-ja) s indinavirom/ritonavirom u dozi od 800/100 mg dvaput na dan plus dva NRTI-ja/NNRTI-ja u više od 300 ispitanika (neliječenih i liječenih inhibitorom proteaze).
English: Contraindicated in combination with saquinavir/ritonavir, due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Croatian: Kontraindiciran je u kombinaciji sa sakvinavirom/ritonavirom zbog rizika od moguće produljene ili pojačane sedacije te respiratorne depresije (vidjeti dio 4.3).
English: Rilpivirine
Croatian: Rilpivirin
English: The number of patients with viral load <50 copies/mL was 9 of 13 for the same period.
Croatian: U istom je razdoblju 9 od 13 bolesnika imalo količinu virusa od < 50 kopija/ml.
English: Saquinavir levels may increase on stopping St. John's wort, and the dose of saquinavir may need adjusting.
Croatian: Nakon prestanka uzimanja gospine trave koncentracija sakvinavira može se povisiti pa može biti potrebna prilagodba doze sakvinavira.
English: Absorption: In HIV-infected adult patients, Invirase in combination with ritonavir at doses of 1000/100 mg twice daily provides saquinavir systemic exposures over a 24-hour period similar to or greater than those achieved with saquinavir soft capsules 1200 mg tid (see Table 8).
Croatian: Apsorpcija: U odraslih bolesnika zaraženih HIV-om Invirase u kombinaciji s ritonavirom u dozi od 1000/100 mg dvaput na dan dovodi do sistemske izloženosti sakvinaviru tijekom 24 sata koja je slična ili veća od izloženosti postignute uz meke kapsule sakvinavira u dozi od 1200 mg triput na dan (vidjeti Tablicu 8).
English: In treatment-naïve HIV-1 infected patients initiating Invirase/ritonavir treatment with a modified Invirase/ritonavir dosing regimen of Invirase 500 mg two times daily with ritonavir 100 mg two times daily for the first 7 days of treatment and increased to Invirase 1000 mg two times daily with ritonavir 100 mg two times daily in the subsequent 7 days, saquinavir systemic exposures generally approached or exceeded the range of historical steady-state values with the standard Invirase/ritonavir 1000 mg/100 mg bid dosing regimen across study days (see Tables 9 and 8).
Croatian: U prethodno neliječenih bolesnika s HIV-1 infekcijom koji započinju liječenje modificiranim režimom doziranja lijekova Invirase/ritonavir, u kojem se tijekom prvih 7 dana primjenjuje Invirase u dozi od 500 mg dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan, a zatim se tijekom sljedećih 7 dana doza poveća na 1000 mg lijeka Invirase dvaput na dan uz ritonavir u dozi od 100 mg dvaput na dan, razine sustavne izloženosti sakvinaviru općenito su se dostigle ili nadmašile raspon vrijednosti u stanju dinamičke ravnoteže zabilježen u prethodnim ispitivanjima u kojima se primjenjivao standardni režim doziranja lijekova Invirase/ritonavir od 1000 mg/100 mg dvaput na dan tijekom svih dana ispitivanja (vidjeti Tablice 9 i 8).
English: Limited safety data are available from a paediatric study (NV20911, n=18) in which the safety of saquinavir hard capsules (50 mg/kg bid, not to exceed 1000 mg bid) used in combination with low dose ritonavir oral solution (3 mg/kg bid for body weight from 5 to <15 kg, 2.5 mg/kg bid for body weight from 15 to 40 kg and 100 mg bid for body weight >40 kg) has been studied in paediatric patients aged 4 months to 6 years old.
Croatian: Dostupni su ograničeni podaci o sigurnosti iz pedijatrijskog ispitivanja (NV20911, n=18) u kojem je u pedijatrijskih bolesnika u dobi od četiri mjeseca do šest godina ispitivana sigurnost primjene tvrdih kapsula sakvinavira (50 mg/kg dvaput na dan, ali ne više od 1000 mg dvaput na dan) u kombinaciji s niskom dozom oralne otopine ritonavira (3 mg/kg dvaput na dan za tjelesnu težinu od 5 do < 15 kg, 2,5 mg/kg za tjelesnu težinu od 15 do 40 kg i 100 mg dvaput na dan za tjelesnu težinu > 40 kg).
English: Monitoring for saquinavir toxicity recommended (see section 4.4).
Croatian: Preporučuje se nadzor zbog moguće toksičnosti sakvinavira (vidjeti dio 4.4).
English: There are limited safety and no efficacy data available from the use of this combination.
Croatian: Podaci o djelotvornosti ove kombinacije nisu dostupni, a podaci o sigurnosti su ograničeni.
English: Concomitant use of bosentan and saquinavir/ritonavir may increase plasma levels of bosentan and may decrease plasma levels of saquinavir/ritonavir.
Croatian: Istodobna primjena bosentana i sakvinavira/ritonavira može povećati koncentracije bosentana u plazmi te smanjiti koncentracije sakvinavira/ritonavira u plazmi.
English: Immunosuppressants Tacrolimus
Croatian: Imunosupresivi Takrolimus
English: - For patients with a baseline QT interval < 450 msec, an on-treatment ECG should be performed.
Croatian: - U bolesnika s početnim QT-intervalom < 450 ms, treba napraviti EKG tijekom liječenja.
English: Concentrations of amiodarone, flecainide or propafenone may be increased when co-administered with Invirase/ritonavir.
Croatian: Koncentracije amiodarona, flekainida i propafenona mogu se povisiti ako se primjenjuju istodobno s lijekovima Invirase/ritonavir.
English: Saquinavir AUC ↓ 51 % Saquinavir Ctrough ↓ 49 % (8 hours post dose)
Croatian: - Sakvinavir AUC ↓ 51% Sakvinavir Ctrough ↓ 49% (8 sati poslije doziranja) Sakvinavir Cmax ↓ 54%.
English: • certain medicines for infection - such as clarithromycin, dapsone, erythromycin, halofantrine,
Croatian: • nekih lijekova za liječenje infekcija - poput klaritromicina, dapsona, eritromicina, halofantrina, pentamidina, sparfloksacina
English: These medicinal products will induce CYP3A4 and may therefore decrease saquinavir concentrations
Croatian: Ovi će lijekovi inducirati aktivnost CYP3A4 te bi stoga mogli sniziti koncentraciju sakvinavira.
English: The mean (% coefficient of variation in parentheses) values for saquinavir AUC0-12 and Cmax were 24.3 (102%) µg·hr/ml and 3.6 (83%) µg/ml, respectively, for HIV-infected patients with moderate hepatic impairment.
Croatian: U bolesnika zaraženih HIV-om s umjerenim oštećenjem jetrene funkcije prosječne vrijednosti (% koeficijenta varijacije u zagradi) AUC0-12 sakvinavira iznosile su 24,3 (102%) µg•hr/ml, a Cmax 3,6 (83%) µg/ml.
English: Interaction with efavirenz: The combination of saquinavir and ritonavir with efavirenz has been shown to be associated with an increased risk of liver toxicity; liver function should be monitored when saquinavir and ritonavir are co-administered with efavirenz.
Croatian: Interakcija s efavirenzom: pokazalo se da je kombinacija sakvinavira i ritonavira s efavirenzom povezana s povećanim rizikom za jetrenu toksičnost.
English: tacrolimus
Croatian: takrolimusa
English: Saquinavir ↑ 100% (double strength grapefruit juice)
Croatian: - Sakvinavir ↑ 50% (sok od grejpa normalne jačine) - Sakvinavir ↑ 100% (sok od grejpa dvostruke jačine)
English: The modified Invirase/ritonavir regimen reduced mean maximum ΔQTcFdense in the first week of treatment compared with the same value in healthy volunteers receiving the standard Invirase/ritonavir dosing regimen in the TQT study on Day 3, (Table 4) based on cross-study comparison in a different population.
Croatian: U sveobuhvatnom ispitivanju QT-intervala, modificirani režim liječenja lijekovima Invirase/ritonavir smanjio je nakon 3 dana srednju vrijednost maksimalnog ΔQTcFdense u prvome tjednu liječenja u usporedbi s istom vrijednošću u zdravih dobrovoljaca koji su primali standardni režim doziranja lijekova Invirase/ritonavir (Tablica 4), što je utvrđeno ukriženim ispitivanjem usporedbe u drugoj populaciji.
English: Paraesthesia, peripheral neuropathy, dizziness, dysgeusia, headache
Croatian: Poremećaji živčanog sustava često parestezija, periferna neuropatija, omaglica, disgeuzija, glavobolja manje često somnolencija, konvulzije
English: Interaction with saquinavir/ritonavir not evaluated.
Croatian: - Interakcija s lijekovima sakvinavir/ritonavir nije procijenjena.
English: Saquinavir AUC ↑ 4.6-7.2 fold
Croatian: - Sakvinavir AUC ↑ 4,6-7,2 puta Indinavir ↔
English: Tipranavir/ritonavir (saquinavir/ritonavir)
Croatian: Tipranavir/ritonavir (sakvinavir/ritonavir)
English: Histamine H2-receptor antagonist - Ranitidine
Croatian: Antagonist histaminskih H2-receptora - Ranitidin (sakvinavir/ritonavir) - Ranitidin (nepojačani sakvinavir)
English: Abnormal heart rhythms (arrhythmias):
Croatian: Poremećaji srčanog ritma (aritmije)