natgillin/translations-raw huggingface dataset:
The G48V mutation, previously identified in vitro as a saquinavir signature mutation, was present at baseline in virus from three patients, none of whom responded to therapy.
Mutacija G48V, koja je ranije in vitro prepoznata kao značajna mutacija povezana sa sakvinavirom, bila je na početku liječenja prisutna u virusu tri bolesnika, od kojih niti jedan nije odgovorio na liječenje.
• medicines used to treat high blood pressure in the arteries of the lungs (a disease known as pulmonary arterial hypertension) such as bosentan.
• lijekove za liječenje visokoga krvnog tlaka u plućnim arterijama (bolest poznata pod nazivom plućna arterijska hipertenzija), poput bosentana
Dose of maraviroc should be decreased to 150 mg bid with monitoring.
Dozu maraviroka treba smanjiti na 150 mg dvaput na dan uz nadzor.
Medicinal products that are substrates of P-glycoprotein Digitalis glycosides
Lijekovi koji su supstrati P-glikoproteina Glikozidi digitalisa
Therefore, when saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on other medicinal products (see the Summary of Product Characteristics for Norvir).
Stoga, kad se sakvinavir primjenjuje istodobno s ritonavirom, treba razmotriti i moguće učinke ritonavira na druge lijekove (vidjeti Sažetak opisa svojstava lijeka za Norvir).
Discontinued assigned treatment, n (%)
Prekinuto propisano liječenje, n (%)
Saquinavir AUC ↓ 24% Nevirapine AUC ↔
- Sakvinavir AUC ↓ 24% Nevirapine AUC ↔
• lurasidone - used to treat schizophrenia.
• lurasidon - koristi se za liječenje shizofrenije
Invirase is indicated for the treatment of HIV-1 infected adult patients.
Invirase je indiciran za liječenje odraslih bolesnika zaraženih virusom HIV-1.
Systemic clearance of saquinavir was high, 1.14 l/h/kg (CV 12 %), slightly above the hepatic plasma flow, and constant after intravenous doses of 6, 36 and 72 mg.
Sistemski klirens sakvinavira je visok: 1,14 l/h/kg (CV 12%), malo veći od protoka plazme kroz jetru, te konstantan nakon intravenskih doza od 6, 36 i 72 mg.
The plasma exposures (AUC values) in rats (maximum dose 1000 mg/kg/day) and in mice (maximum dose 2500 mg/kg/day) were lower than the expected plasma exposures obtained in humans at the recommended clinical dose of ritonavir boosted Invirase.
Izloženost u plazmi (vrijednosti AUC) u štakora (maksimalna doza 1000 mg/kg/dan) i miševa (maksimalna doza 2500 mg/kg/dan) bila je manja od očekivane izloženosti u plazmi koja se postiže u ljudi pri preporučenoj kliničkoj dozi lijeka Invirase pojačanog ritonavirom.
Table 6: Subject Demographics MaxCmin1 and MaxCmin2†
Tablica 6: Demografske karakteristike ispitanika u ispitivanjima MaxCmin1 i MaxCmin2† MaxCmin1
• concurrent therapy with any of the following drugs, which may interact and result in potentially life-threatening undesirable effects (see sections 4.4, 4.5 and 4.8): - drugs that prolong the QT and/or PR interval (see sections 4.4 and 4.5) - midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), triazolam (potential for prolonged or increased sedation, respiratory depression) - simvastatin, lovastatin (increased risk of myopathy including rhabdomyolysis) - ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (potential for acute ergot toxicity) - rifampicin (risk of severe hepatocellular toxicity) (see sections 4.4, 4.5, and 4.8) - quetiapine (risk of coma, see section 4.5).
• koji istodobno uzimaju neki od sljedećih lijekova, koji mogu ulaziti u interakcije i dovesti do nuspojava koje mogu biti opasne po život (vidjeti dijelove 4.4, 4.5 i 4.8): - lijekove koji produljuju QT i/ili PR-interval (vidjeti dijelove 4.4 i 4.5) - midazolam primijenjen peroralno (za mjere opreza kod parenteralne primjene midazolama, vidjeti dio 4.5), triazolam (mogućnost produljene ili pojačane sedacije, respiratorne depresije) - simvastatin, lovastatin (povećan rizik od miopatije, uključujući rabdomiolizu) - ergot alkaloide (npr. ergotamin, dihidroergotamin, ergonovin i metilergonovin) (mogućnost akutne toksičnosti ergota) - rifampicin (rizik od teške hepatocelularne toksičnosti) (vidjeti dijelove 4.4, 4.5, i 4.8). - kvetiapin (rizik od kome, vidjeti dio 4.5) - lurasidon (mogućnost pojave ozbiljnih i/ili po život opasnih reakcija, vidjeti dio 4.5)
There are also some medicines that require dosage reduction of that medicine or Invirase or ritonavir (see section “Medicines that can interact with saquinavir or ritonavir include:” below).
Postoje i neki lijekovi zbog kojih se mora smanjiti doza tih lijekova ili lijeka Invirase ili ritonavira (vidjeti odlomak „Lijekovi koji mogu uzajamno djelovati sa sakvinavirom ili ritonavirom uključuju:“ u nastavku).
Cobicistat is not recommended in combination with regimens containing ritonavir due to similar effects of cobicistat and ritonavir on CYP3A.
Primjena kobicistata nije preporučena u kombinaciji s režimima liječenja koji sadrže ritonavir zbog sličnog učinka kobicistata i ritonavira na CYP3A.
Table 10: Pharmacokinetic parameters of saquinavir at steady-state in HIV-infected pediatric patients
Tablica 10: Farmakokinetički parametri sakvinavira u stanju dinamičke ravnoteže u pedijatrijskih bolesnika zaraženih HIV-om
Other medicinal products known to increase the plasma concentration of ritonavir-boosted Invirase should be used with caution.
Druge lijekove za koje se zna da povećavaju koncentraciju lijeka Invirase pojačanog ritonavirom u plazmi treba primjenjivati uz oprez.
Ritonavir ↓ (effectiveness as boosting agent not modified).
Ritonavir ↓ (nije promijenjena djelotvornost ritonavira kao pojačivača)
Invirase film-coated tablets should be swallowed whole and taken at the same time as ritonavir with or after food (see section 5.2).
Invirase kapsule moraju se progutati cijele i uzimati u isto vrijeme kao i ritonavir, uz obrok ili poslije njega (vidjeti dio 5.2).
The combination of Invirase/ritonavir with drugs known to increase the exposure of saquinavir is not recommended and should be avoided when alternative treatment options are available.
Kombinacija lijekova Invirase/ritonavir s lijekovima za koje se zna da povećavaju izloženost sakvinaviru se ne preporučuje i treba je izbjegavati ako postoje druge mogućnosti liječenja.
Consideration should be given for performing baseline and follow-up electrocardiograms after initiation of treatment, e.g. in patients taking concomitant medication known to increase the exposure of saquinavir (see section 4.5).
Treba razmotriti snimanje početnog i kontrolnih elektrokardiograma nakon započinjanja liječenja, npr. u bolesnika koji istodobno uzimaju lijekove koji povećavaju izloženost sakvinaviru (vidjeti dio 4.5).
Co-administration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with preexisting liver disease.
Istodobna primjena sakvinavira i ritonavira dovela je do teških štetnih događaja, uglavnom dijabetičke ketoacidoze i poremećaja jetrene funkcije, osobito u bolesnika s postojećom bolešću jetre.
Change in Baseline Plasma HIV-1 RNA at Week 4
Promjena početne HIV-1 RNA u plazmi u tjednu 4
Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Tegobe s kostima: U nekih bolesnika koji uzimaju kombiniranu antiretrovirusnu terapiju može se razviti bolest kostiju koja se zove osteonekroza (propadanje koštanog tkiva zbog prestanka opskrbe kosti krvlju).
Saquinavir AUC ↑ 348%.
- Sakvinavir AUC ↑ 348%.
Tyrosine kinase inhibitors All tyrosine kinase inhibitors with a risk of QT prolongation e.g. dasatinib, sunitinib
Inhibitori tirozin kinaze Svi inhibitori tirozin kinaze kod kojih postoji rizik od produljenja QT-intervala, npr. dasatinib, sunitinib
How to take Invirase
Kako uzimati Invirase
Invirase contains the active substance saquinavir which is an antiviral agent.
Invirase sadrži djelatnu tvar sakvinavir koji je antivirusni lijek.
Invirase/ritonavir may increase concentrations of tricyclic antidepressants.
Lijekovi Invirase/ritonavir mogu povisiti koncentracije tricikličkih antidepresiva.
The clinical relevance of these findings from this study in healthy volunteers to the use of Invirase/ritonavir in HIV-infected patients is unclear, but doses exceeding Invirase/ritonavir 1000/100 mg twice daily should be avoided.
Klinički značaj tih nalaza iz ovog ispitivanja provedenog u zdravih dobrovoljaca za primjenu lijekova Invirase/ritonavir u bolesnika zaraženih HIV-om nije jasan, ali treba izbjegavati doze lijekova Invirase/ritonavir veće od 1000/100 mg dvaput na dan.
Osteonecrosis: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Osteonekroza: Iako se smatra da ima više uzroka (uključujući uzimanje kortikosteroida, konzumiranje alkohola, jaku imunosupresiju, povećan indeks tjelesne mase), osteonekroza je prijavljena posebno u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika na dugotrajnoj kombiniranoj antiretrovirusnoj terapiji (CART).
Decreased libido, sleep disorder
Psihijatrijski poremećaji često smanjen libido, poremećaj spavanja
Low dose ritonavir increases the concentration of indinavir.
- Male doze ritonavira povisuju koncentraciju indinavira.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING TEXT FOR THE BOTTLE LABEL
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU TEKST NA NALJEPNICI BOCE
Ritonavir can affect the pharmacokinetics of other medicinal products because it is a potent inhibitor of CYP3A4 and P-gp.
Ritonavir može utjecati na farmakokinetiku drugih lijekova jer je snažan inhibitor CYP3A4 i P-gp.
Calcium channel blockers Felodipine, nifedipine, nicardipine, diltiazem, nimodipine, verapamil, amlodipine, nisoldipine, isradipine (saquinavir/ritonavir)
Blokatori kalcijskih kanala Felodipin, nifedipin, nikardipin, diltiazem, nimodipin, verapamil, amlodipin, nisoldipin, isradipin (sakvinavir/ritonavir)
Antiviral activity in vitro: Saquinavir demonstrates antiviral activity against a panel of laboratory strains and clinical isolates of HIV-1 with typical EC50 and EC90 values in the range 1-10 nM and 5-50 nM, respectively, with no apparent difference between subtype B and non-B clades.
Antivirusna aktivnost in vitro: Sakvinavir pokazuje antivirusnu aktivnost protiv palete laboratorijskih sojeva i kliničkih izolata HIV-1, s tipičnim vrijednostima EC50 u rasponu od 1 do 10 nM, a EC90 od 5 do 50 nM, bez vidljive razlike između izolata virusnog podtipa B i virusa koji ne pripadaju podtipu B.
Ritonavir inhibits the metabolism of saquinavir, thereby increasing ("boosting") the plasma levels of saquinavir.
Ritonavir inhibira metabolizam sakvinavira, povećavajući na taj način razinu sakvinavira u plazmi („pojačavajući ga“).
Based on the finding of dose-dependent prolongations of QT and PR intervals in healthy volunteers receiving Invirase/ritonavir (see sections 4.3, 4.4 and 5.1), additive effects on QT and PR interval prolongation may occur.
Na temelju saznanja o produljenju QT i PR-intervala ovisnom o dozi u zdravih dobrovoljaca koji su primali Invirase/ritonavir (vidjeti dijelove 4.3, 4.4 i 5.1), mogu nastupiti dodatni učinci na produljenje QT i PR-intervala.
Effects of high fluticasone systemic exposure on ritonavir plasma levels yet unknown.
Učinci sustavne izloženosti visokim razinama flutikazona na koncentraciju ritonavira u plazmi još nisu poznati.
If you take more Invirase than you should
Ako uzmete više Invirase kapsula nego što ste trebali
No data are available on the concomitant administration of Invirase/ritonavir and other proton pump inhibitors.
Nema podataka o istodobnoj primjeni lijekova Invirase/ritonavir i ostalih inhibitora protonske pumpe.
• decompensated liver disease (see section 4.4)
• s dekompenziranom bolešću jetre (vidjeti dio 4.4)
Invirase is prescribed for use in combination with ritonavir (Norvir) and other antiretroviral medicines.
Invirase se propisuje za primjenu u kombinaciji s ritonavirom (Norvir) i drugim antiretrovirusnim lijekovima.
Saquinavir Cmin ↓ 78% Dual-boosted protease inhibitor combination therapy in multipletreatment experienced HIV-positive adults.
Sakvinavir Cmin ↓ 78% Dvostruko pojačana kombinirana terapija inhibitorom proteaze u odraslih bolesnika zaraženih HIV-om koji su prethodno liječeni višestrukom terapijom.
Virological response was first observed to decrease when the fold shift exceeded 2.3-fold; whereas virological benefit was not observed when the fold shift exceeded 12-fold.
Pad virološkog odgovora prvi put je uočen kad je faktor pomaka bio veći od 2,3; kad faktor pomaka premaši 12, više se ne opaža virološka korist.
There have been reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Prijavljena je i bol, osjetljivost ili slabost u mišićima, osobito kod primjene kombinirane antiretrovirusne terapije koja obuhvaća i inhibitore proteaze i analoge nukleozida.
Streptogramin antibiotics such as quinupristin/dalfopristin inhibit CYP3A4.
- Streptograminski antibiotici poput kvinupristina/dalfopristina inhibiraju CYP3A4.
The mean steady-state volume of distribution following intravenous administration of a 12 mg dose of saquinavir was 700 l (CV 39 %).
Prosječan volumen raspodjele u stanju dinamičke ravnoteže nakon intravenske primjene 12 mg sakvinavira iznosio je 700 l (CV 39%).
• medicines to treat depression - such as nefazodone, tricyclic antidepressants
• lijekove za liječenje depresije, poput nefazodona, tricikličkih antidepresiva
Saquinavir/ritonavir concentrations not measured, no effect is expected.
Nisu izmjerene koncentracije sakvinavira/ritonavira, ne očekuje se nikakav učinak.
It is unknown whether medicinal products which reduce the gastrointestinal transit time could lead to lower saquinavir plasma concentrations.
Nije poznato mogu li lijekovi koji skraćuju vrijeme prolaza kroz probavni sustav sniziti koncentraciju sakvinavira u plazmi.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2.
Safety pharmacology: Cloned human cardiac potassium channel (hERG) trafficking in vitro was inhibited by 75% at 30μM of saquinavir.
Sigurnosna farmakologija: prolaz kroz kalijeve kanale (hERG) kloniranih stanica ljudskog srca in vitro inhibiran je za 75% pri 30μmol sakvinavira.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) - Delavirdine
Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) - Delavirdin
For comprehensive dose adjustment recommendations and drug-associated adverse reactions for ritonavir and other medicinal products used in combination with saquinavir, physicians should refer to the Summary of Product Characteristics for each of these medicinal products.
Za sveobuhvatne preporuke o prilagodbi doza te nuspojave povezane s ritonavirom i drugim lijekovima koji se primjenjuju u kombinaciji sa sakvinavirom liječnici trebaju proučiti Sažetak opisa svojstava lijeka za svaki od tih lijekova.
In a myocardial distribution study in the rat an approximately 2-fold accumulation of saquinavir was observed in the heart compared to plasma after coadministration of saquinavir and ritonavir.
U istraživanju raspodjele u miokardu u štakora opažena je gotovo dvostruka akumulacija sakvinavira u srcu u odnosu na plazmu nakon istodobne primjene sakvinavira i ritonavira.
The frequency of this is unknown (see section 4.4).
Učestalost ovih nuspojava nije poznata (vidjeti dio 4.4).
Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy.
Tjelesna težina i metabolički parametri: Povećanje tjelesne težine i razina lipida i glukoze u krvi mogu se pojaviti tijekom antiretrovirusne terapije.
Clinical experience in pregnant women is limited: Congenital malformations, birth defects and other disorders (without a congenital malformation) have been reported rarely in pregnant women who had received saquinavir in combination with other antiretroviral agents.
Kliničko je iskustvo primjene lijeka u trudnica ograničeno: u rijetkim su slučajevima prijavljene kongenitalne deformacije, urođene mane i drugi poremećaji (bez kongenitalnih deformacija) u trudnica koje su uzimale sakvinavir u kombinaciji s drugim antiretrovirusnim lijekovima.
Saquinavir inhibited both hERG current and L-type Ca++ channel current with respective IC50s of 4.7 and 6.3 μM.
Sakvinavir je inhibirao i prolaz kroz hERG i prolaz kroz Ca++ kanal tipa L, uz vrijednosti IC50 od 4,7 odnosno 6,3 μmol.
None of the subjects in the lopinavir/ritonavir arm had been exposed to lopinavir prior to randomisation whereas 16 of the subjects in the saquinavir/ritonavir arm had previously been exposed to saquinavir.
Nijedan ispitanik u skupini liječenoj lopinavirom/ritonavirom nije bio izložen lopinaviru prije randomizacije, dok je 16 ispitanika u skupini liječenoj sakvinavirom/ritonavirom već bilo izloženo sakvinaviru.
Although specific studies have not been performed, co-administration of Invirase/ritonavir with medicinal products that are mainly metabolised by CYP3A4 pathway may result in elevated plasma concentrations of these medicinal products.
Iako nisu provedena posebna ispitivanja, istodobna primjena lijekova Invirase/ritonavir s lijekovima koji se uglavnom metaboliziraju putem CYP3A4 može rezultirati povišenim koncentracijama tih lijekova u plazmi.
• certain medicines commonly used for allergy symptoms such as terfenadine and astemizole
• nekih lijekova koji se često koriste za liječenje simptoma alergije, poput terfenadina i astemizola
• a weak heart (heart failure)
• ako imate slabo srce (zatajivanje srca)
PR intervals of > 200 msec were seen in 3% of subjects in the active control group (moxifloxacin) and 5% in the placebo arm.
PR-intervali > 200 ms opaženi su u 3% ispitanika u skupini koja je primala aktivni kontrolni lijek (moksifloksacin) te u 5% ispitanika u skupini koja je primala placebo.
Liver disease: Please speak with your doctor if you have a history of liver disease.
Bolest jetre: Porazgovarajte s liječnikom ako ste imali bolest jetre.
Since the magnitude of QT and PR prolongation increases with increasing concentrations of saquinavir, the recommended dose of ritonavir-boosted Invirase should not be exceeded.
Budući da se povećanjem koncentracije sakvinavira povećava produljenje QT i PR-intervala, ne smije se prekoračiti preporučena doza lijeka Invirase pojačanog ritonavirom.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 October 1996
Datum prvog odobrenja: 4. listopada 1996.
Invirase may have a minor influence on the ability to drive and use machines.
Invirase može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
Women and elderly patients may be more susceptible to drug-associated effects on the QT and/or PR interval.
Žene i stariji bolesnici mogu biti osjetljiviji na s lijekom povezane učinke na QT i/ili PR-interval.
There was no QT prolongation > 500 msec and no torsade de pointes in the study (see also section 4.4).
U ispitivanju nije zabilježeno produljenje QT-intervala > 500 ms kao niti torsade de pointes (vidjeti i dio 4.4).
Concomitant use of colchicine and saquinavir/ritonavir is expected to increase plasma levels of colchicine due to P-gp and/or CYP3A4 inhibition by the protease inhibitor.
Očekuje se da će istodobna primjena kolhicina i sakvinavira/ritonavira povećati koncentracije kolhicina u plazmi zbog inhibicije P-gp i/ili CYP3A4 inhibitorom proteaze.
Dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Treba razmisliti o smanjenju doze glukokortikoida uz pomno praćenje lokalnih i sustavnih učinaka, ili prijelazu na neki glukokortikoid koji nije supstrat CYP3A4 (npr. beklometazon).
Gastroenterological medicinal products Metoclopramide
Gastroenterološki lijekovi: Metoklopramid
Invirase/ritonavir should be administered with or after food.
Invirase/ritonavir treba primijeniti uz obrok ili nakon njega.
There were no clinically significant differences in the pharmacokinetic profile of ritonavir in fasting and fed conditions but the ritonavir Ctrough (geometric mean 245 vs. 348 ng/ml) was lower in the fasting state compared to the administration with a meal.
Nije bilo klinički značajnih razlika u farmakokinetičkom profilu ritonavira primijenjenoga natašte u odnosu na primjenu s hranom, ali je Ctrough ritonavira bio manji nakon uzimanja lijeka natašte u usporedbi s primjenom uz obrok (geometrijska sredina 245 naprama 348 ng/ml).
Plasma concentrations of trazodone may increase.
Mogu se povećati koncentracije trazodona u plazmi.
Invirase is not recommended for use in combination with cobicistat as dosing recommendations for this combination have not been established.
Ne preporuča se primjena lijeka Invirase u kombinaciji s kobicistatom, jer preporuke doziranja za tu kombinaciju lijekova nisu utvrđene.
Interaction with tipranavir: Concomitant use of boosted saquinavir and tipranavir, co-administered with low dose ritonavir in a dual-boosted regimen, results in a significant decrease in saquinavir plasma concentrations (see section 4.5).
Interakcija s tipranavirom: Istodobna primjena sakvinavira pojačanog potpornim lijekom s tipranavirom i niskom dozom ritonavira u dvostruko pojačanom režimu liječenja, rezultira značajno sniženim koncentracijama sakvinavira u plazmi (vidjeti dio 4.5).
• any heart problems that show on an electrocardiogram (ECG, electrical recording of the heart)
• ako imate bilo kakve srčane tegobe koje se vide na elektrokardiogramu (EKG, električni zapis rada srca) - možda ste se rodili s time
Other potential interactions Medicinal products that are substrates of CYP3A4 e.g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl
Druge moguće interakcije Lijekovi koji su supstrati CYP3A4 Npr. dapson, dizopiramid, kinin, fentani i alfentanil
Effect of gender following treatment with Invirase/ritonavir: A gender difference was observed with females showing higher saquinavir exposure than males (AUC on average 56 % higher and Cmax on average 26 % higher) in the bioequivalence study comparing Invirase 500 mg film coated tablets with Invirase 200 mg hard capsules both in combination with ritonavir.
Utjecaj spola na liječenje lijekovima Invirase/ritonavir: Razlika s obzirom na spol opažena je u žena koje su pokazale veću izloženost sakvinaviru od muškaraca (AUC prosječno 56% viši, a Cmax prosječno 26% viši) u ispitivanju bioekvivalencije u kojemu su uspoređene Invirase 500 mg filmom obložene tablete s Invirase 200 mg tvrdim kapsulama, oboje u kombinaciji s ritonavirom.
Gastric pH has been shown to be only a minor component in the large increase in bioavailability seen when given with food.
Pokazalo se da je pH želuca tek sporedna komponenta velikog povećanja bioraspoloživosti koje se opaža kod uzimanja lijeka s hranom.
• some medicines affecting the immune system - such as ciclosporin, sirolimus (rapamycin),
• neke lijekove koji djeluju na imunološki sustav, poput ciklosporina, sirolimusa (rapamicina),
Concomitant administration of Invirase and lurasidone is contraindicated as it may increase lurasidone-related toxicity (see section 4.3).
Istodobna primjena lijeka Invirase i lurasidona je kontraindicirana jer može povećati toksičnost povezanu s lurasidonom (vidjeti dio 4.3).
TQT Study Day 3* (n=57)
Sveobuhvatno ispitivanje QT-intervala 3. dan* (n=57)