FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients stable on ritonavir-boosted Invirase and requiring concomitant medication with potential to increase the exposure of saquinavir or patients on medication with potential to increase the exposure of saquinavir and requiring concomitant ritonavir-boosted Invirase where no alternative therapy is available and the benefits outweigh the risks: - An ECG should be performed prior to initiation of the concomitant therapy: patients with a QT interval > 450 msec should not initiate the concomitant therapy (see section 4.5).
Croatian: Bolesnici koji su stabilni na liječenju lijekom Invirase pojačanim ritonavirom i trebaju istodobno uzimati lijekove koji mogu povećati izloženost sakvinaviru ili bolesnici koji se liječe lijekovima koji mogu povećati izloženost sakvinaviru i trebaju istodobno uzimati Invirase pojačan ritonavirom, kada nema terapijske alternative i korist od liječenja nadmašuje rizike: - Prije započinjanja istodobnog liječenja treba napraviti EKG: bolesnici s QT-intervalom > 450 ms ne smiju započeti istodobno liječenje (vidjeti dio 4.5).
English: Liver function should be monitored (see section 4.4).
Croatian: Potrebno je nadzirati jetrenu funkciju (vidjeti dio 4.4).
English: Interaction with ritonavir: The recommended dose of Invirase and ritonavir is 1000 mg Invirase plus 100 mg ritonavir twice daily.
Croatian: Interakcija s ritonavirom: Preporučena doza lijeka Invirase s ritonavirom je 1000 mg lijeka Invirase plus 100 mg ritonavira dvaput na dan.
English: Additionally, in vitro studies have shown that saquinavir is a substrate and an inhibitor for P-glycoprotein (P-gp).
Croatian: Osim toga, istraživanja in vitro pokazala su da je sakvinavir supstrat i inhibitor P-glikoproteina (P-gp).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmascist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: Table 3: Maximum mean of ddQTcS† (msec) on day 3 for therapeutic dose of Invirase/ritonavir, supra-therapeutic dose of Invirase/ritonavir and active control moxifloxacin in healthy volunteers in Thorough QT (TQT) Study
Croatian: Tablica 3: Najviše prosječne vrijednosti ddQTcS† (ms) za terapijsku dozu lijekova Invirase/ritonavir, supraterapijsku dozu lijekova Invirase/ritonavir i aktivni kontrolni lijek moksifloksacin izmjerene 3. dana doziranja u zdravih dobrovoljaca u sveobuhvatnom ispitivanju QT-intervala
English: MaxCmin2: any rise > 0.5 log at a specific visit; < 0.5 log reduction if VL > 200 copies/ml at week 4; < 1.0 log reduction from base line if VL > 200 copies/ml at week 12; and a VL > 200 copies/ml at week 24.
Croatian: MaxCmin2: svako povećanje od ≥ 0,5 log pri određenom posjetu; smanjenje od ≤ 0,5 log ako je količina virusa ≥ 200 kopija/ml u 4. tjednu; smanjenje za ≤ 1,0 log od početne vrijednosti ako je količina virusa ≥ 200 kopija/ml u 12. tjednu ili količina virusa ≥ 200 kopija/ml u 24. tjednu.
English: Caution should be used with coadministration of Invirase and parenteral midazolam.
Croatian: Potreban je oprez pri istodobnoj primjeni lijeka Invirase i parenteralno primijenjenog midazolama.
English: - Delavirdine (unboosted saquinavir)
Croatian: - Delavirdin (nepojačani sakvinavir)
English: • certain medicines for HIV - such as atazanavir, lopinavir, rilpivirine
Croatian: • nekih lijekova za liječenje HIV infekcije, poput atazanavira, lopinavira, rilpivirina
English: 13 % of circulating saquinavir in plasma was present as unchanged compound after oral administration and the remainder as metabolites.
Croatian: Nakon peroralne je primjene 13% sakvinavira u cirkulaciji bilo prisutno u plazmi u obliku nepromijenjenog spoja, a ostatak u obliku metabolita.
English: How to store Invirase
Croatian: Kako čuvati Invirase
English: If this is your first medicine for HIV or the first time you are taking ritonavir (Norvir) You need to take a lower dose of Invirase for your first week.
Croatian: Ako ranije niste uzimali druge lijekove za liječenje HIV infekcije ili sada prvi puta uzimate ritonavir (Norvir)
English: If no alternative treatment is available, use with careful monitoring (see section
Croatian: Ako nema terapijske alternative, primjenjivati uz poman nadzor (vidjeti dio 4.4).
English: Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking "SQV 500" on the one side and "ROCHE" on the other side.
Croatian: Svijetlonarančaste do sivkaste ili smećkasto-narančaste filmom obložene tablete ovalnog, cilindričnog, bikonveksnog oblika, s oznakom “SQV 500” na jednoj i “ROCHE” na drugoj strani.
English: Both drugs are CYP3A4 inhibitors and may increase the plasma concentration of saquinavir.
Croatian: Oba su lijeka inhibitori CYP3A4 i mogu povisiti koncentraciju sakvinavira u plazmi.
English: • a salt imbalance in your blood, especially low blood concentrations of potassium (hypokalaemia),
Croatian: • ako imate neravnotežu soli u krvi, osobito nisku razinu kalija u krvi (hipokalijemija) koju trenutno ne liječite
English: Metabolism of pravastatin and fluvastatin is not dependent on CYP3A4.
Croatian: Metabolizam pravastatina i fluvastatina ne ovisi o CYP3A4.
English: These results suggest that the QTc liability is reduced with the modified Invirase/ritonavir dosing regimen, based on a cross-study comparison in a different population (Table 4).
Croatian: Ti rezultati ukazuju na to da je uz modificirani režim liječenja lijekovima Invirase/ritonavir učinak na QTc smanjen, što je utvrđeno ukriženim ispitivanjem usporedbe u drugoj populaciji (Tablica 4).
English: Careful therapeutic drug monitoring is necessary for these immunosuppressants when coadministered with Invirase/ritonavir.
Croatian: Neophodna je pažljiva kontrola terapijskih koncentracija tih imunosupresiva kad se primjenjuju istodobno s lijekovima Invirase/ritonavir.
English: Number of Saquinavir Associated Resistance Mutations at Baseline*
Croatian: Broj mutacija povezanih s otpornošću na sakvinavir na početku ispitivanja*
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.
Croatian: U bolesnika zaraženih HIV-om koji u vrijeme početka kombinirane antiretrovirusne terapije (CART) imaju tešku imunodeficijenciju može doći od upalne reakcije na asimptomatske ili rezidualne oportunističke infekcije.
English: Marcelin et al (2007) identified nine protease codons (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V, L90M) that were associated with decreased virological response to saquinavir/ritonavir (1000/100 mg twice daily) in 138 saquinavir naive patients.
Croatian: Marcelin i suradnici (2007) su u 138 bolesnika koji prethodno nisu liječeni sakvinavirom ustanovili devet kodona proteaze (L10F/I/M/R/V, I15A/V, K20I/M/R/T, L24I, I62V, G73S/T, V82A/F/S/T, I84V i L90M) koji su povezani sa smanjenim virološkim odgovorom na sakvinavir/ritonavir (1000/100 mg dvaput na dan).
English: Lactose intolerance: Invirase 500 mg film-coated tablets contain lactose.
Croatian: Nepodnošenje laktoze: Invirase 500 mg filmom obložene tablete sadrže laktozu.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
Croatian: U okolnostima imunološke reaktivacije prijavljena je i pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do njihova nastupa je varijabilnije i mogu se pojaviti i više mjeseci nakon započinjanja liječenja.
English: For patients with a QT interval < 450 msec, an on treatment ECG is recommended.
Croatian: U bolesnika s QT-intervalom < 450 ms preporučuje se napraviti EKG tijekom liječenja.
English: Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).
Croatian: Invirase se smije primjenjivati samo u kombinaciji s ritonavirom i drugim antiretrovirusnim lijekovima (vidjeti dio 4.2).
English: Digoxin 0.5 mg single dose (saquinavir/ritonavir
Croatian: Digoksin jednokratna doza od 0,5 mg (sakvinavir/ritonavir
English: In the “High Age Group”, the number of patients with a viral load <400 copies/mL at week 48 was 11 of 13.
Croatian: U ''starijoj dobnoj skupini'' 11 od 13 bolesnika imalo je količinu virusa od < 400 kopija/ml u 48. tjednu.
English: Invirase 500 mg film-coated tablets Saquinavir
Croatian: Invirase 500 mg filmom obložene tablete sakvinavir
English: - Garlic capsules (dose approx. equivalent to two 4 g cloves of garlic daily) (unboosted saquinavir 1200 mg tid)
Croatian: - Kapsule češnjaka (doza približno ekvivalentna količini od dva češnja od 4 g na dan) (nepojačani sakvinavir 1200 mg triput na dan)
English: Ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (saquinavir/ritonavir)
Croatian: Ergot alkaloidi (npr. ergotamin, dihidroergotamin, ergonovin i metilergonovin) (sakvinavir/ritonavir)
English: Clozapine
Croatian: Klozapin
English: Do not use this medicine after the expiry date (EXP) which is stated on the bottle and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
English: Biotransformation and elimination in adults: In vitro studies using human liver microsomes have shown that the metabolism of saquinavir is cytochrome P450 mediated with the specific isoenzyme, CYP3A4, responsible for more than 90 % of the hepatic metabolism.
Croatian: Ispitivanja in vitro u kojima su korišteni ljudski jetreni mikrosomi pokazala su da je metabolizam sakvinavira posredovan citokromom P450, pri čemu je specifičan izoenzim CYP3A4 odgovoran za više od 90% metabolizma u jetri.
English: Table 4: Summary of Electrocardiogram Parameters following administration of the Modified Invirase/ritonavir Regimen in Treatment Naïve HIV-1 infected Patients initiating treatment with Invirase/ritonavir
Croatian: Tablica 4: Sažetak elektrokardiografskih parametara nakon primjene modificiranog režima doziranja lijekova Invirase/ritonavir u prethodno neliječenih bolesnika s HIV-1 infekcijom koji započinju liječenje kombinacijom Invirase/ritonavir
English: • certain heart medicines - such as calcium channel blockers, quinidine, digoxin
Croatian: • neke lijekove za liječenje srčanih bolesti, poput blokatora kalcijskih kanala, kinidina, digoksina
English: • an allergy to saquinavir, ritonavir or any of the other ingredients (see “Invirase contains lactose”
Croatian: • ako ste alergični na sakvinavir, ritonavir ili neki drugi sastojak (vidjeti odlomak “Invirase sadrži laktozu” u nastavku ovoga dijela i odlomak “Što Invirase sadrži” u dijelu 6.)
English: Monitoring of saquinavir plasma concentration might be indicated.
Croatian: Možda će biti indicirano praćenje koncentracija sakvinavira u plazmi.
English: The absolute bioavailability of saquinavir co-administered with ritonavir has not been established in humans.
Croatian: Apsolutna bioraspoloživost sakvinavira u kombiniranoj terapiji s ritonavirom u ljudi nije utvrđena.
English: For zidovudine (200 mg every 8 hours) a 25 % decrease in AUC was reported when combined with ritonavir (300 mg every 6 hours).
Croatian: Kad je zidovudin (200 mg svakih 8 sati) primijenjen u kombinaciji s ritonavirom (300 mg svakih 6 sati), prijavljeno je smanjenje AUC-a zidovudina za 25%.
English: Concomitant administration of boosted saquinavir and fluticasone propionate and other corticosteroids metabolised via the P450 3A pathway (e.g. budesonide) is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena sakvinavira pojačanog potpornim lijekom i flutikazonpropionata ili drugih kortikosteroida koji se metaboliziraju putem P450 3A (npr. budezonid), osim ako potencijalna korist liječenja ne nadmašuje rizike od sustavnih učinaka kortikosteroida (vidjeti dio 4.4).
English: • certain antibiotics - such as quinupristin/dalfopristin, rifabutin, fusidic acid
Croatian: • neke antibiotike, poput kinupristina/dalfopristina, rifabutina, fusidatne kiseline
English: Most drug interaction studies with saquinavir have been completed with unboosted Invirase or unboosted saquinavir soft capsules.
Croatian: Većina ispitivanja interakcija sa sakvinavirom provedena je s nepojačanim lijekom Invirase ili s nepojačanim mekim kapsulama sakvinavira.
English: Table 9: Mean (CV%) PK Parameters following administration of the Modified Invirase/ritonavir Regimen in Treatment Naïve HIV-1 infected Patients initiating treatment with Invirase/ritonavir Parameter Day 3 500/100 mg (n=22)
Croatian: Tablica 9: Srednje vrijednosti (CV%) farmakokinetičkih parametara nakon primjene modificiranog režima doziranja lijekova Invirase/ritonavir u prethodno neliječenih bolesnika s HIV-1 infekcijom koji započinju liječenje kombinacijom Invirase/ritonavir Parametar 3. dan 500/100 mg (n=22)
English: Saquinavir AUC ↑ 67 %
Croatian: - Sakvinavir AUC ↑ 67%
English: On Day 3, mean Cmax values were approximately 3-fold and 4-fold higher with the therapeutic and supra-therapeutic doses, respectively, relative to the mean Cmax observed at steady state with the therapeutic dose administered to HIV patients.
Croatian: Trećega su dana prosječne vrijednosti Cmax bile trostruko veće pri terapijskim, a četverostruko veće pri supraterapijskim dozama u odnosu na prosječni Cmax zabilježen u stanju dinamičke ravnoteže kod primjene terapijskih doza bolesnicima zaraženima HIV-om.
English: Saquinavir concentrations may be increased.
Croatian: Koncentracije sakvinavira mogu se povisiti.
English: No dosage adjustment is necessary for HIV-infected patients with mild hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika zaraženih HIV-om s blagim oštećenjem jetrene funkcije.
English: Not studied.
Croatian: Nije ispitivana.
English: Effective therapy in treatment experienced patients is associated with a Cmin of approximately 100 ng/ml and an AUC0-24 of about 20,000 ng·h/ml.
Croatian: U već liječenih bolesnika učinkovito je liječenje povezano s vrijednostima Cmin od približno 100 ng/ml i AUC0-24 od približno 20 000 ng•h/ml.
English: QT and PR prolongation on electrocardiogram: The effects of therapeutic (1000/100 mg twice daily) and supra-therapeutic (1500/100 mg twice daily) doses of Invirase/ritonavir on the QT interval were evaluated in a 4-way crossover, double-blind, placebo- and active-controlled (moxifloxacin 400 mg) study in healthy male and female volunteers aged 18 to 55 years old (N=59).
Croatian: Produljenje QT i PR-intervala na elektrokardiogramu: Učinci terapijskih (1000/100 mg dvaput na dan) i supraterapijskih (1500/100 mg dvaput na dan) doza lijekova Invirase/ritonavir na QT-interval ispitani su u četverosmjerno ukriženom, dvoslijepom ispitivanju s kontrolom placeba i aktivne kontrole (moksifloksacin 400 mg) u zdravih dobrovoljaca oba spola u dobi od 18 do 55 godina (N=59).
English: Antiretroviral agents
Croatian: Antiretrovirusni lijekovi
English: When bosentan is administered concomitantly with saquinavir/ritonavir, the patient's tolerability of bosentan should be monitored.
Croatian: Kada se bosentan primjenjuje istodobno sa sakvinavirom/ritonavirom, treba pratiti kako bolesnik podnosi bosentan.
English: Elderly patients may be more susceptible to drug-associated effects on the QT and/or PR interval.
Croatian: Stariji bolesnici mogu biti skloniji pojavi učinaka povezanih s lijekom koji djeluju na QT i/ili PR interval.
English: Patients with chronic diarrhoea or malabsorption: No information on boosted saquinavir and only limited information on the safety and efficacy of unboosted saquinavir is available for patients suffering from chronic diarrhoea or malabsorption.
Croatian: Bolesnici s kroničnim proljevom ili malapsorpcijom: Za bolesnike s kroničnim proljevom ili malapsorpcijom postoje tek ograničeni podaci o sigurnosti primjene i djelotvornosti nepojačanog sakvinavira, dok nema podataka za sakvinavir pojačan potpornim lijekom.
English: Patients with hepatic impairment: The effect of hepatic impairment on the steady state pharmacokinetics of saquinavir/ritonavir (1000 mg/100 mg twice daily for 14 days) was investigated in 7 HIV-infected patients with moderate liver impairment (Child Pugh Grade B score 7 to 9).
Croatian: Bolesnici s oštećenom jetrenom funkcijom: Utjecaj oštećenja jetrene funkcije na farmakokinetiku sakvinavira/ritonavira u stanju dinamičke ravnoteže (1000 mg/100 mg dvaput na dan tijekom 14 dana) ispitan je u sedam bolesnika zaraženih HIV-om s umjerenim oštećenjem jetrene funkcije (Child Pugh stadij B, 7 do 9 bodova).
English: No dose adjustment of saquinavir/ritonavir is required.
Croatian: Nije potrebna prilagodba doze sakvinavira/ritonavira.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 500 mg sakvinavira u obliku sakvinavirmesilata.
English: Patients should also be advised that they might experience undesirable effects associated with coadministered medications.
Croatian: Bolesnike treba uputiti i da će možda imati nuspojave povezane s istodobno primijenjenim lijekovima.
English: Invirase is used by HIV-1-infected adults.
Croatian: Invirase se koristi u osoba zaraženih virusom HIV 1.
English: • Take two 500 mg film-coated tablets of Invirase twice a day.
Croatian: • Uzmite dvije Invirase filmom obložene tablete od 500 mg dvaput na dan.
English: Sultopride
Croatian: Sultoprid
English: Adverse reactions from two pivotal studies of saquinavir soft capsule (1000 mg twice daily) used in combination with low dose ritonavir (100 mg twice daily) for at least 48 weeks are summarised in Table 2.
Croatian: Nuspojave iz dvaju pivotalnih ispitivanja mekih kapsula sakvinavira (1000 mg dvaput na dan) primjenjivanih u kombinaciji s niskom dozom ritonavira (100 mg dvaput na dan) tijekom najmanje 48 tjedana prikazane su u Tablici 2.
English: • previous history of symptomatic arrhythmias
Croatian: • koji u anamnezi imaju simptomatske aritmije
English: Effective therapy in treatment naïve patients is associated with a Cmin of approximately 50 ng/ml and an AUC0-24 of about 20,000 ng·h/ml.
Croatian: U prethodno neliječenih bolesnika učinkovito je liječenje povezano s vrijednostima Cmin od približno 50 ng/ml i AUC0-24 od približno 20 000 ng•h/ml.
English: • Take one 500 mg film-coated tablet of Invirase twice a day.
Croatian: • Uzmite jednu Invirase filmom obloženu tabletu od 500 mg dvaput na dan.
English: • medicines used to lower blood cholesterol - such as statins
Croatian: • lijekove za sniženje razine kolesterola u krvi, poput statina
English: Breast-feeding: There are no laboratory animal or human data available on secretion of saquinavir in breast milk.
Croatian: Dojenje: Nema podataka o izlučivanju sakvinavira u majčino mlijeko ni u laboratorijskih životinja ni u ljudi.
English: Maprotiline's metabolism appears to involve the cytochrome P450 isozymes CYP2D6 and CYP 1A2 Associated with a prolongation of QTc intervals.
Croatian: Čini se da u metabolizmu maprotilina sudjeluju izoenzimi CYP2D6 i CYP1A2 citokroma P450
English: The combination of saquinavir and ritonavir exhibited a superior virological activity compared with the indinavir and ritonavir arm when switch from the assigned treatment was counted as virological failure.
Croatian: U usporedbi sa skupinom liječenom indinavirom i ritonavirom, kombinacija sakvinavira i ritonavira pokazala je bolju virološku aktivnost kada se prelazak s propisane terapije smatrao izostankom virološkog odgovora.
English: MaxCmin1: For those entering with VL > 200 copies/ml, VF defined as any increase > 0.5 logs and/or VL > 50,000 copies/ml at week 4, > 5,000 copies/ml at week 12, or > 200 copies/ml at week 24 or thereafter.
Croatian: MaxCmin1: za bolesnike koji su u ispitivanje ušli s količinom virusa ≥ 200 kopija/ml, izostanak virološkog odgovora definira se kao svako povećanje od ≥ 0,5 log i/ili količina virusa ≥ 50 000 kopija/ml u 4. tjednu, ≥ 5000 kopija/ml u 12. tjednu ili ≥ 200 kopija/ml u 24. tjednu ili kasnije.
English: Saquinavir ↔ Efavirenz ↔
Croatian: Sakvinavir ↔ Efavirenz ↔
English: Conversely, other drugs that induce CYP3A4 may also reduce saquinavir plasma concentrations.
Croatian: Nasuprot tome, drugi lijekovi koji induciraju CYP3A4 mogu sniziti koncentracije sakvinavira u plazmi.
English: Plasma concentrations highly dependent on CYP3A4 metabolism.
Croatian: Koncentracije u plazmi jako ovise o metabolizmu CYP3A4.
English: Proportion with VL < 50 copies/ml at week 48, ITT/e#
Croatian: Udio bolesnika s količinom virusa < 50 kopija/ml u 48. tjednu, ITT/e#
English: In this study, 5 patients were <2 years and 13 between 2 to <6 years and received 50 mg/kg saquinavir bid (not to exceed 1000 mg bid) boosted with ritonavir at 3 mg/kg for patients with body weight ranging from 5 to <15 kg or 2.5 mg/kg for patients with body weight ranging from 15 to 40 kg (not to exceed 100 mg bid).
Croatian: U tom je ispitivanju bilo pet bolesnika u dobi < 2 godine te 13 u dobi od 2 do < 6 godina, koji su primali 50 mg/kg sakvinavira dvaput na dan (ali ne više od 1000 mg dvaput na dan), pojačanog ritonavirom u dozi od 3 mg/kg za bolesnike tjelesne težine od 5 do <15 kg ili 2,5 mg/kg za bolesnike tjelesne težine od 15 do 40 kg (ali ne više od 100 mg dvaput na dan).
English: Ritonavirboosted Invirase at a dose of 2000 mg once daily with ritonavir 100 mg once daily has not been studied with regard to the risk of QT prolongation and is not recommended.
Croatian: Nije ispitivan utjecaj doze lijeka Invirase od 2000 mg jednom na dan, pojačanog ritonavirom u dozi od 100 mg jednom na dan, na rizik produljenja QT-intervala te se ta doza ne preporučuje.
English: Invirase should only be given in combination with ritonavir (see section 4.2).
Croatian: Invirase se smije primjenjivati samo u kombinaciji s ritonavirom (vidjeti dio 4.2).
English: Dose adjustment of bosentan may be required.
Croatian: Možda će biti potrebno smanjiti dozu bosentana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TEXT FOR THE OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TEKST NA KUTIJI LIJEKA
English: Sex
Croatian: Spol
English: - Patients demonstrating a subsequent increase in QT-interval to > 480 msec or prolongation over pre-treatment by > 20 msec should discontinue ritonavir-boosted Invirase.
Croatian: - Bolesnici u kojih se utvrdi naknadno produljenje QT-intervala na > 480 ms ili produljenje u odnosu na početne vrijednosti za > 20 ms trebaju prestati uzimati Invirase pojačan ritonavirom.
English: Mean Invirase Cmax with the modified Invirase/ritonavir regimen was approximately 53-83% lower across study days in the HIV-1 infected patients relative to the mean Cmax achieved in healthy volunteers in the TQT study on Day 3.
Croatian: U sveobuhvatnom ispitivanju QT-intervala je 3. dana liječenja srednji Cmax lijeka Invirase uz primjenu modificiranog režima doziranja lijekova Invirase/ritonavir bio približno 53-83% niži tijekom dana ispitivanja u bolesnika s HIV-1 infekcijom u odnosu na srednji Cmax postignut u zdravih dobrovoljaca.
English: Recommendations concerning coadministration
Croatian: Preporuke za istodobnu primjenu
English: Saquinavir AUC ↑ 13% (90% CI: 27↓ - 74↑) Saquinavir Cmax ↑ 9% (90% CI: 27↓ - 61↑ ) Nelfinavir AUC ↓ 6% (90% CI: 28↓ - 22↑) Nelfinavir Cmax ↓ 5% (90% CI: 23↓ - 16↑)
Croatian: - Sakvinavir AUC ↑ 13% (90% CI: 27↓ - 74↑) Sakvinavir Cmax ↑ 9% (90% CI: 27↓ - 61↑ ) Nelfinavir AUC ↓ 6% (90% CI: 28↓ - 22↑) Nelfinavir Cmax ↓ 5% (90% CI: 23↓ - 16↑)
English: • anticonvulsants - such as phenobarbital, phenytoin, carbamazepine
Croatian: • antikonvulzive, poput fenobarbitala, fenitoina, karbamazepina