natgillin/translations-raw huggingface dataset:
Decrease estimated creatinine clearance
Smanjenje procijenjenog klirensa kreatinina
NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone
NARKOTIČKI ANALGETICI / LIJEČENJE OVISNOSTI O OPIJATIMA Buprenorfin/nalokson
The median change in eGFRCG was -5.5 mL/min with D/C/F/TAF and -12.0 mL/min with D/C+F/TDF (p < 0.001).
Medijan promjene vrijednosti eGFRCG iznosio je -5,5 ml/min uz D/K/F/TAF te -12,0 ml/min uz D/K+F/TDF (p < 0,001).
Concomitant use of Symtuza may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Istodobna primjena lijeka Symtuza može povisiti rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde.
Yellow to yellowish-brown capsule shaped tablet of 22 mm x 11 mm, debossed with “8121” on one side and “JG” on the other side.
Žuta do žućkasto-smeđa tableta oblika kapsule, dimenzija 22 mm x 11 mm, s utisnutom oznakom “8121” na jednoj strani i “JG” na drugoj strani.
- Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Clotrimazole, fluconazole, Isavuconazole, itraconazole, posaconazole, (for treating fungal infections).
- digoksin (za liječenje određenih srčanih poremećaja) - klaritromicin (antibiotik) - klotrimazol, flukonazol, izavukonazol, itrakonazol, posakonazol (za liječenje gljivičnih infekcija).
Non-black
Sve osim crne
Tell your doctor if you develop any of the following side effects.
Obavijestite svog liječnika ako primijetite bilo koju od sljedećih nuspojava.
The median baseline CD4+ cell count was 628 x 10
Medijan početne vrijednosti broja CD4+ stanica bio je 628 x 10
As Symtuza contains darunavir, cobicistat, emtricitabine, and tenofovir alafenamide, the adverse reactions associated with each of the individual compounds may be expected.
Budući da Symtuza sadrži darunavir, kobicistat, emtricitabin i tenofoviralafenamid, mogu se očekivati nuspojave povezane sa svakom od tih pojedinačnih sastavnica.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolesnike treba uputiti da se obrate liječniku ako osjete bolove u zglobovima, ukočenost zglobova ili imaju poteškoća pri kretanju.
Emerging Resistance in AMBER and EMERALD Trial (Week 96)
Tablica 4: Pojava rezistencije u ispitivanjima AMBER i EMERALD (96. tjedan)
Dose adjustment for buprenorphine may not be necessary when co-administered with Symtuza, but a careful clinical monitoring for signs of opiate toxicity is recommended.
Možda neće biti potrebna prilagodba doze buprenorfina kada se primjenjuje istodobno s lijekom Symtuza, no preporučuje se pažljivo kliničko praćenje kako bi se uočili znakovi opijatne toksičnosti.
Darunavir and cobicistat are metabolised by CYP3A.
Darunavir i kobicistat metaboliziraju se pomoću CYP3A.
Voriconazole should not be combined with Symtuza unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Vorikonazol se ne smije kombinirati s lijekom Symtuza, osim ako procjena omjera koristi i rizika opravdava primjenu vorikonazola.
For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
U nekim slučajevima postoji dokaz o učinku liječenja na razinu lipida, no nema čvrstih dokaza koji bi povezali povećanje tjelesne težine s bilo kojim konkretnim liječenjem.
The dosage of other medicines might need to be changed since either their own or Symtuza's therapeutic effect or side effects may be influenced when combined.
Možda će biti potrebno prilagoditi dozu drugih lijekova zbog moguće promjene terapijskog učinka ili nuspojava tih lijekova ili lijeka Symtuza kada se primjenjuju u kombinaciji.
Difference in Proportions
Razlika u udjelima
Studies in animals have demonstrated that darunavir, cobicistat and tenofovir are excreted in milk.
Ispitivanja na životinjama pokazala su da se darunavir, kobicistat i tenofovir izlučuju u mlijeko.
It is not known whether the co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g. febuxostat) would increase systemic exposure to tenofovir.
Nije poznato bi li istodobna primjena tenofoviralafenamida i inhibitora ksantin oksidaze (npr. febuksostata) povećala sistemsku izloženost tenofoviru.
• vomiting, pain or swelling of the belly, indigestion, flatulence (wind)
• povraćanje, bol ili oticanje trbuha, probavne tegobe, vjetrovi
Five subjects were discontinued from the study due to efficacy related reasons per investigator's assessment (physician decision), of which 3 had last on treatment HIV-1 RNA <50 copies/mL.
Pet je ispitanika isključeno iz ispitivanja zbog razloga povezanih s djelotvornošću prema ocjeni ispitivača (odluci liječnika), od kojih je njih troje imalo HIV-1 RNK < 50 kopija/ml pri posljednjem određivanju tijekom liječenja.
Cobicistat inhibits the transporters p-glycoprotein (P-gp), BCRP, MATE1, OATP1B1 and OATP1B3.
Kobicistat inhibira prijenosnike Pglikoprotein (P-gp), BCRP, MATE1, OATP1B1 i OATP1B3.
Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (N = 12, age ≥ 65 years) (see section 4.4).
Populacijska farmakokinetička analiza podataka prikupljenih u bolesnika zaraženih HIV-om pokazala je da se farmakokinetika darunavira ne razlikuje bitno unutar dobnog raspona (18 - 75 godina) koji se ocjenjivao u bolesnika zaraženih HIV-om (N = 12, dob ≥ 65 godina) (vidjeti dio 4.4).
Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Istodobna primjena emtricitabina i lijekova koji se eliminiraju aktivnom tubularnom sekrecijom može povećati koncentracije emtricitabina i/ili istodobno primijenjenih lijekova.
Phase 3 trial TMC114IFD3013 (EMERALD) evaluated the efficacy of Symtuza in virologicallysuppressed (HIV-1 RNA less than 50 copies/mL) HIV-1 infected patients.
Ispitivanje faze 3 TMC114IFD3013 (EMERALD) procijenilo je djelotvornost lijeka Symtuza u virološki suprimiranih (HIV-1 RNK manje od 50 kopija/mL) bolesnika s HIV-1 infekcijom.
There are no adequate and well controlled trials with darunavir, cobicistat, emtricitabine, or tenofovir alafenamide, alone or in combination, in pregnant women.
Nisu provedena odgovarajuća i dobro kontrolirana ispitivanja darunavira, kobicistata, emtricitabina i tenofoviralafenamida, primijenjenih samostalno ili u kombinaciji, u trudnica.
In studies in treatment-naïve patients, Symtuza was associated with a lower impact on the estimated glomerular filtration rate by Cockcroft-Gault method compared to control group (DRV/COBI+F/TDF).
U ispitivanju kod bolesnika koji prethodno nisu bili liječeni, Symtuza je bila povezana s manjim utjecajem na procijenjenu brzinu glomerularne filtracije prema Cockcroft-Gaultovoj formuli u usporedbi s kontrolnom skupinom (DRV/KOBI+F/TDF).
Symtuza should not be administered concomitantly with medicinal products requiring pharmacokinetic enhancement with ritonavir or cobicistat.
Symtuza se ne smije primjenjivati istodobno s lijekovima kojima je potrebno farmakokinetičko pojačanje ritonavirom ili kobicistatom.
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide express a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Izolati virusa HIV-1 sa smanjenom osjetljivošću na tenofoviralafenamid nose mutaciju K65R u HIV-1 RT; osim toga, kratkotrajno je primijećena mutacija K70E u HIV-1 RT.
Appropriate laboratory testing should be conducted prior to initiating therapy with Symtuza and patients should be monitored during treatment.
Prije početka liječenja lijekom Symtuza treba provesti odgovarajuće laboratorijske pretrage, a tijekom liječenja bolesnike treba pratiti.
In a multiple dose trial with darunavir/ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, N = 8) and moderate (Child-Pugh Class B, N = 8) hepatic impairment were comparable with those in healthy subjects.
U ispitivanjima primjene višekratnih doza darunavira/ritonavira (600/100 mg) dvaput na dan pokazalo se da su ukupne plazmatske koncentracije darunavira u ispitanika s blagim (Child-Pugh stadij A, N = 8) i umjerenim (Child-Pugh stadij B, N = 8) oštećenjem jetrene funkcije usporedive s onima u zdravih ispitanika.
These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale-coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Oni mogu uključivati žutu boju kože ili bjeloočnica, tamnu mokraću (boje čaja), blijedu stolicu (pražnjenje crijeva), mučninu, povraćanje, gubitak teka ili bol, tupu bol ili bol i nelagodu na desnoj strani tijela ispod rebara.
Limited information is available in this population, and, therefore, Symtuza should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Za ovu populaciju dostupni su ograničeni podaci, pa se Symtuza stoga treba primjenjivati uz oprez u bolesnika starijih od 65 godina (vidjeti dijelove 4.4 i 5.2).
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are coadministered with Symtuza.
Preporučuju se druge ili zamjenske kontracepcijske mjere kada se kontraceptivi na bazi estrogena primjenjuju istodobno s lijekom Symtuza.
Blood and lymphatic system disorders common anaemia
Poremećaji krvi i limfnog sustava često anemija
Patients had a median age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
Medijan dobi bolesnika iznosio je 15 godina (raspon: 12 - 17); 56% bolesnika bile su žene, 12% Azijati, a 88% crnci.
Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Tenofoviralafenamid se uglavnom eliminira nakon metabolizacije u tenofovir.
Patients co-infected with hepatitis B and/or hepatitis C virus Limited information is available on the use of Symtuza components in patients co-infected with hepatitis B and/or C virus.
Bolesnici istodobno zaraženi virusom hepatitisa B i/ili hepatitisa C Dostupne su ograničene informacije o primjeni sastavnica lijeka Symtuza u bolesnika istodobno zaraženih virusom hepatitisa B i/ili C.
* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
6/l u plazmi (vidjeti dio 5.1). * DRV-RAM-ovi: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Bubrežno izlučivanje nepromijenjenog tenofoviralafenamida sporedni je put, kojim se manje od 1% doze izlučuje kroz mokraću.
The combination may result in increased risk of cardiovascular adverse events with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Primjena navedene kombinacije može dovesti do povećanog rizika od kardiovaskularnih štetnih događaja povezanih sa salmeterolom, uključujući produljenje QT intervala, palpitacije i sinusnu tahikardiju.
No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Nije potrebno prilagođavati dozu lijeka Symtuza u bolesnika s procijenjenom brzinom glomerularne filtracije prema Cockcroft-Gaultovoj formuli (eGFRCG) ≥ 30 ml/min.
Symtuza should be used with caution in patients with a known sulphonamide allergy.
Lijek Symtuza treba primjenjivati uz oprez u bolesnika s poznatom alergijom na sulfonamide.
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Pokazalo se da kobicistat smanjuje procijenjeni klirens kreatinina zbog inhibicije tubularne sekrecije kreatinina.
PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE5) Za liječenje erektilne disfunkcije Sildenafil
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Symtuza.
Toksičnost za kost manifestirala se kao smanjena mineralna gustoća kosti u štakora i pasa pri izloženostima tenofoviru najmanje četiri puta većima od onih očekivanih nakon primjene lijeka Symtuza.
The safety and efficacy of Symtuza or its components have not been established in patients with severe underlying liver disorders.
Sigurnost i djelotvornost lijeka Symtuza ili njegovih sastavnica u bolesnika s teškim poremećajima jetrene funkcije nisu ustanovljene.
Symtuza should be discontinued in patients with eGFRCG that declines below 30 mL/min during treatment (see sections 5.1 and 5.2).
Liječenje lijekom Symtuza treba prekinuti u bolesnika u kojih eGFRCG tijekom liječenja padne ispod 30 ml/min (vidjeti dijelove 5.1 i 5.2).
The pharmacologically active metabolite, tenofovir diphosphate, has a half-life of 150-180 hours within PBMCs.
Poluvijek farmakološki aktivnog metabolita, tenofovirdifosfata, u mononuklearnim stanicama periferne krvi iznosi 150 - 180 sati.
Based on stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and CD4+ cell count (< 200 or ≥ 200 cells/µL).
Temeljeno na MH testu prilagođenom prema stratumu gdje su stratifikacijski faktori razina HIV-1 RNK (≤100 000 ili > 100 000 kopija/mL) i broj CD4+ stanica (< 200 ili ≥200 stanica/µL).
- lopinavir/ritonavir - St. John's wort (Hypericum perforatum)
- lopinavir/ritonavir - gospina trava (Hypericum perforatum)
ANTIFUNGALS Clotrimazole Fluconazole Itraconazole
ANTIMIKOTICI Klotrimazol Flukonazol Itrakonazol
H2-RECEPTOR ANTAGONISTS Cimetidine
ANTAGONISTI H2 RECEPTORA
PROTON PUMP INHIBITORS Dexlansoprazole
INHIBITORI PROTONSKE PUMPE Dekslanzoprazol
Treatment with darunavir/cobicistat 800/150 mg during the second and third trimester has been shown to result in low darunavir exposure, with a reduction of around 90% in Cmin levels (see section 5.2).
Liječenje darunavirom/kobicistatom 800/150 mg tijekom drugog i trećeg tromjesečja rezultiralo je niskom izloženošću darunaviru, sa smanjenjem od otprilike 90% Cmin razina (vidjeti dio 5.2).
FDA Snapshot Outcome HIV-1 RNA < 50 copies/mL Virologic Failure
FDA Snapshot ishod HIV-1 RNK < 50 kopija/mL Virološki neuspjeh
The recommended dose regimen in adults and adolescents aged 12 years and older, weighing at least 40 kg, is one tablet taken once daily with food.
Preporučeni režim doziranja u odraslih i adolescenata u dobi od 12 godina i starijih, tjelesne težine od najmanje 40 kg, je jedna tableta jedanput na dan, s hranom.
During the darunavir/ritonavir clinical development program (N = 3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Tijekom programa kliničkog razvoja darunavira/ritonavira (N = 3063) u 0,4% bolesnika prijavljene su teške kožne reakcije, koje mogu biti praćene vrućicom i/ili povišenim vrijednostima transaminaza.
At Week 48 changes from baseline were smaller with D/C/F/TAF than D/C+F/TDF.
Promjene od početne vrijednosti u 48. tjednu bile su manje uz D/K/F/TAF nego uz D/K+F/TDF.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment (see section 4.4).
Prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do njihova nastupa je varijabilno, pa se oni mogu javiti i više mjeseci nakon početka liječenja (vidjeti dio 4.4).
The emtricitabine-resistant virus with the M184M/I/V mutation was cross-resistant to lamivudine, but retained sensitivity to abacavir, stavudine, tenofovir, and zidovudine.
Virus rezistentan na emtricitabin s mutacijom M184M/I/V bio je križno rezistentan na lamivudin, ali je zadržao osjetljivost na abakavir, stavudin, tenofovir i zidovudin.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Za nadzor lipida i glukoze u krvi postoje preporuke u utvrđenim smjernicama za liječenje HIV-a.
Store in the original package with desiccant inside the bottle in order to protect the tablets from moisture.
Čuvati u originalnom pakiranju sa sredstvom za sušenje u boci radi zaštite tableta od vlage.
Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Nepromijenjen darunavir činio je približno 41,2% primijenjene doze u fecesu, odnosno 7,7% primijenjene doze u mokraći.
Nervous system disorders very common headache common dizziness
Poremećaji živčanog sustava vrlo često glavobolja često omaglica
Isavuconazole Posaconazole
Izavukonazol Posakonazol
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Prijavljeni su i neki neurološki poremećaji s odgođenim nastupom (hipertonija, konvulzije, neuobičajeno ponašanje).
Expected interactions between Symtuza with potential concomitant medicinal products are listed in Table 1 below and are based on the studies conducted with the components of Symtuza, as individual agents or combined, or are potential drug interactions that may occur.
Očekivane interakcije između lijeka Symtuza i mogućih istodobno primijenjenih lijekova navedene su u Tablici 1 u nastavku i temelje se na ispitivanjima provedenima sa sastavnicama lijeka Symtuza primijenjenima zasebno ili u kombinaciji, ili predstavljaju moguće interakcije između lijekova.
In vivo, darunavir resistance-associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V and L89V) in HIV-1 protease were derived from clinical trial data of ART-experienced patients, all of whom were protease inhibitor experienced.
In vivo, mutacije proteaze virusa HIV-1 povezane s rezistencijom na darunavir (V11I, V32I, L33F, I47V, I50V, I54L ili M, T74P, L76V, I84V i L89V) temelje se na podacima iz kliničkih ispitivanja provedenih u bolesnika prethodno liječenih antiretrovirusnom terapijom, od kojih su svi prethodno primali inhibitor proteaze.
During the darunavir/ritonavir clinical development program (N = 3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Tijekom programa kliničkog razvoja (N = 3063), hepatitis je prijavljen u 0,5% bolesnika koji su primali kombiniranu antiretrovirusnu terapiju darunavirom/ritonavirom.
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
Početna vrijednost virusnog opterećenja ≤100 000 kopija/mL >100 000 kopija /mL
After 96 weeks of treatment with Symtuza, the (95% CI) percent changes from baseline in BMD at the hip and spine region were respectively: -0.26 (-0.96; 0.45) % and -0.93 (-1.82; -0.05) %.
Nakon 96 tjedana liječenja lijekom Symtuza, postotna promjena (95% CI) početne mineralne gustoće kostiju na području kuka i kralježnice iznosila je -0,26 (-0,96; 0,45) % odnosno -0,93 (-1,82; -0,05) %.
Pantoprazole
Pantoprazol
In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Ispitivanja in vitro te klinička ispitivanja farmakokinetičkih interakcija između lijekova pokazala su malu mogućnost interakcija emtricitabina s drugim lijekovima u kojima posreduju enzimi CYP.
- Colchicine (antigout).
- kolhicin (za liječenje gihta).
Genotypic testing should guide the use of Symtuza (see sections 4.2, 4.4, and 5.1).
Kod primjene lijeka Symtuza treba se voditi genotipskim pretragama (vidjeti dijelove 4.2, 4.4 i 5.1).
There is no specific antidote for overdose with Symtuza.
Nema specifičnog protulijeka za predoziranje lijekom Symtuza.
In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.
U nekih bolesnika s uznapredovalom jetrenom bolešću ili cirozom prekid liječenja može dovesti do pogoršanja hepatitisa, koje može biti opasno po život.
At peak plasma concentration, the mean plasma to blood drug concentration ratio was approximately 1.0 and the mean semen to plasma drug concentration ratio was approximately 4.0.
Pri vršnoj koncentraciji u plazmi srednja vrijednost omjera koncentracije lijeka između plazme i krvi iznosila je približno 1,0, a srednja vrijednost omjera koncentracije lijeka između sjemena i plazme približno 4,0.
Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of tenofovir alafenamide and development of resistance.
Očekuje se da će lijekovi koji induciraju aktivnost P-gp-a (npr. rifampicin, rifabutin, karbamazepin, fenobarbital) smanjiti apsorpciju tenofoviralafenamida te tako uzrokovati sniženje njegove plazmatske koncentracije, što može dovesti do gubitka terapijskog učinka tenofoviralafenamida i razvoja rezistencije.
Cobicistat is 97% to 98% bound to human plasma proteins and the mean plasma to blood-drug concentration ratio was approximately 2.
Udio kobicistata koji se vezuje za proteine u plazmi ljudi iznosi 97 - 98%, a srednja vrijednost omjera koncentracije lijeka između plazme i krvi iznosila je približno 2.
Darunavir contains a sulphonamide moiety.
Darunavir sadrži sulfonamidnu komponentu.
The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Sigurnost emtricitabina i tenofoviralafenamida u kombinaciji s elvitegravirom i kobicistatom u tableti s fiksnom kombinacijom doza ocjenjivala se u približno 70 bolesnika istodobno zaraženih HIV-om i HBV-om koji su u tom trenutku primali liječenje za HIV infekciju u otvorenom kliničkom ispitivanju (GS-US-292-1249).
However, there are pharmacokinetic data for the different components of Symtuza, indicating that doses of 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide result in similar exposures in adults and adolescents aged 12 years and older, weighing at least 40 kg.
Međutim, postoje farmakokinetički podaci za različite sastavnice lijeka Symtuza, koji pokazuju da doze darunavira od 800 mg, kobicistata od 150 mg, emtricitabina od 200 mg i tenofoviralafenamida od 10 mg dovode do slične izloženosti u odraslih i adolescenata u dobi od 12 ili više godina, tjelesne težine od najmanje 40 kg.
The recommended dose for adults and adolescents 12 years of age and older, who weigh at least 40 kg is one tablet each day with food.
Preporučena doza u odraslih i adolescenata u dobi od 12 ili više godina i tjelesne težine od najmanje 40 kg je jedna tableta svaki dan s hranom.
Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Tablica 8 Farmakinetički rezultati ukupnog darunavira nakon primjene darunavira/kobicistata 800/150 mg jedanput na dan kao dijela antiretrovirusnog režima, tijekom drugog tromjesečja trudnoće, trećeg tromjesečja trudnoće i u postpartalnom razdoblju Farmakinetika ukupnog darunavira (srednja vrijednost ± SD)
There are no pharmacokinetic data on tenofovir alafenamide in patients with eGFRCG < 15 mL/min.
Nema podataka o farmakokinetici tenofoviralafenamida u bolesnika kojima je eGFRCG < 15 ml/min.