natgillin/translations-raw huggingface dataset:
The safety and efficacy of Descovy in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Sigurnost i djelotvornost primjene lijeka Descovy u bolesnika istodobno zaraženih virusom HIV-1 i virusom hepatitisa C (HCV) nisu ustanovljene.
Patients receiving Descovy or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and, therefore, should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
U bolesnika koji primaju lijek Descovy ili neku drugu antiretrovirusnu terapiju mogu se i dalje razvijati oportunističke infekcije i druge komplikacije infekcije HIV-om, pa bi stoga morali ostati pod strogim kliničkim nadzorom liječnika koji imaju iskustva u liječenju bolesnika s bolestima povezanim s HIV-om.
What you need to know before you take Descovy Do not take Descovy:
Što morate znati prije nego počnete uzimati lijek Descovy Nemojte uzimati lijek Descovy:
Virologic success rates at Week 48 were: Descovy Containing Regimen: 89.7% (227 of 253 subjects); Abacavir/lamivudine Containing Regimen: 92.7%% (230 of 248 subjects).
Stope virološkog uspjeha u 48. tjednu bile su sljedeće: režim koji je sadržavao lijek Descovy: 89,7% (227 od 253 ispitanika); režim koji je sadržavao abakavir/lamivudin: 92,7% (230 od 248 ispitanika).
Stopping Descovy can seriously affect how well future treatment works.
Prestanak uzimanja lijeka Descovy može ozbiljno utjecati na djelotvornost budućeg liječenja.
If you take more than the recommended dose of Descovy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Ako uzmete više od preporučene doze lijeka Descovy, može Vam se povećati rizik od nuspojava ovog lijeka (pogledajte dio 4, Moguće nuspojave).
Third agent in HIV treatment regimen (see section 4.5)
Treći lijek u režimu liječenja HIV-a (vidjeti dio 4.5)
The safety and efficacy of Descovy in patients with significant underlying liver disorders have not been established (see sections 4.2 and 5.2).
Sigurnost i djelotvornost primjene lijeka Descovy u bolesnika sa značajnim podležećim bolestima jetre nisu ustanovljene (vidjeti dijelove 4.2 i 5.2).
Some patients taking combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Neki bolesnici koji uzimaju kombinirane antiretrovirusne lijekove kao što je Descovy mogu razviti bolest kostiju koja se zove osteonekroza (odumiranje koštanog tkiva prouzrokovano gubitkom prokrvljenosti kosti).
Medicines used in treating hepatitis B infection:
Lijekovi za liječenje infekcije virusom hepatitisa B:
The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Na distribuciju tenofoviralafenamida u tijelu može utjecati aktivnost OATP1B1 i OATP1B3.
Do not stop taking Descovy
Nemojte prestati uzimati lijek Descovy
Other medicines and Descovy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate FTC = emtricitabine; TAF = tenofovir alafenamide fumarate; TFV = tenofovir N/A = not applicable
E/C/F/TAF =elvitegravir/kobicistat/emtricitabin/tenofoviralafenamidfumarat FTC = emtricitabin; TAF = tenofoviralafenamidfumarat; TFV = tenofovir
Table 2: Interactions between the individual components of Descovy and other medicinal products
Tablica 2: Interakcije između pojedinih komponenti lijeka Descovy i drugih lijekova Lijekovi prema terapijskim područjima1
Through 144 weeks of treatment, no subject discontinued E/C/F/TAF due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
U 144 tjedna liječenja nijedan ispitanik nije prekinuo primjenu E/C/F/TAF-a zbog štetnog događaja nastalog tijekom liječenja povezanog s funkcijom bubrega, u usporedbi s 12 ispitanika koji su prekinuli primjenu E/C/F/TDF-a (p < 0,001).
No dose adjustment of norgestimate/ethinylestradiol is required.
Nije potrebna prilagodba doze norgestimata/etinilestradiola.
Antimycobacterials Rifabutin
Antimikobakterijski lijekovi Rifabutin
If you forget to take Descovy
Ako ste zaboravili uzeti lijek Descovy
Descovy should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Descovy has not been established in these populations.
Primjenu lijeka Descovy potrebno je izbjegavati u bolesnika s procijenjenim CrCl ≥ 15 ml/min i < 30 ml/min, ili < 15 ml/min koji nisu na kroničnoj hemodijalizi, jer sigurnost primjene lijeka Descovy u ovih populacija nije ustanovljena.
If you feel dizzy when taking Descovy, do not drive and do not use any tools or machines.
Ako tijekom uzimanja lijeka Descovy imate omaglicu, nemojte upravljati vozilom niti raditi s alatima ili na strojevima.
7 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposurers expected in HCV-infected patients.
7 Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se postigle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
• lamivudine
• lamivudin
In vitro Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Smanjena osjetljivost na emtricitabin povezana je s M184V/I mutacijama u HIV-1 RT.
The pharmacokinetics of emtricitabine have not been studied in subjects with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Farmakokinetika emtricitabina nije ispitana u ispitanika s oštećenjem funkcije jetre; međutim emtricitabin se neznatno metabolizira putem enzima jetre, pa bi učinak oštećenja funkcije jetre trebao biti ograničen.
The mean steady state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Srednja vrijednost najniže koncentracije u plazmi pri dinamičkoj ravnoteži 24 sata nakon primjene doze bila je jednaka ili veća od srednje vrijednosti IC90 in vitro za anti-HIV-1 djelovanje.
It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes.
Nije poznato je li tenofoviralafenamid inhibitor drugih UGT enzima.
Although kidney problems have not been observed with Descovy, there is a possibility that you may experience kidney problems when taking Descovy over a long period of time.
Iako uz Descovy nisu opažene tegobe s bubrezima, postoji mogućnost da Vam se jave tegobe s bubrezima ako uzimate Descovy tijekom dugog vremenskog razdoblja.
No antagonism was observed with emtricitabine or tenofovir alafenamide when combined with other antiretroviral agents.
Nije bio opažen antagonizam s emtricitabinom ili tenofoviralafenamidom kad su se kombinirali s drugim antiretrovirusnim lijekovima.
• anticonvulsants, used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital and phenytoin
• antikonvulzive, primjenjuju se za liječenje epilepsije, kao što su: karbamazepin, okskarbazepin, fenobarbital i fenitoin
Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Tenofoviralafenamid se transportira P-glikoproteinom (P-gp) i proteinom rezistencije karcinoma dojke (BCRP).
At baseline, median eGFR was 56 mL/min, and 33% of patients had an eGFR from 30 to 49 mL/min.
Medijan eGFR na početku iznosio je 56 ml/min, a 33% bolesnika imalo je eGFR od 30 do 49 ml/min.
Emtricitabine and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture.
Emtricitabin i tenofoviralafenamid pokazuju sinergističko antivirusno djelovanje u staničnoj kulturi.
Medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption.
Lijekovi koji jako utječu na aktivnost P-gp-a i BCRP-a mogu dovesti do promjena u apsorpciji tenofoviralafenamida.
Adults and adolescents aged 12 years and older, weighing at least 35 kg Descovy should be administered as shown in Table 1.
Odrasli i adolescenti u dobi od 12 godina i stariji, s tjelesnom težinom od najmanje 35 kg Descovy se primjenjuje kako je prikazano u Tablici 1.
Do not stop taking Descovy without talking to your doctor.
Nemojte prestati uzimati lijek Descovy bez prethodnog razgovora sa svojim liječnikom.
Descovy in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Descovy se u kombinaciji s drugim lijekovima primjenjuje za liječenje infekcije virusom humane imunodeficijencije 1 (HIV-1) u odraslih i adolescenata u dobi od 12 godina i starijih, koji imaju tjelesnu težinu od najmanje 35 kg.
There have been reports of a high rate of virological failure and of emergence of resistance at an early stage when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Zabilježene su visoke stope virološkog neuspjeha i pojave rezistencije u ranoj fazi kad se tenofovirdizoproksil kombinirao s lamivudinom i abakavirom, kao i s lamivudinom i didanozinom, u režimu jedanput dnevno.
No emergent resistance to E/C/F/TAF was detected through Week 48.
Do kraja 48. tjedna nije bila otkrivena pojava rezistencije na E/C/F/TAF.
Dose Descovy according to the concomitant antiretroviral (see section 4.2).
Dozirati Descovy ovisno o istodobno primjenjivanim antiretrovirusnim lijekovima (vidjeti dio 4.2).
Descovy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
Descovy se ne smije primjenjivati istodobno s lijekovima koji sadržavaju tenofoviralafenamid, tenofovirdizoproksil, emtricitabin, lamivudin ili adefovirdipivoksil.
Relative to fasting conditions, the administration of tenofovir alafenamide with a high fat meal (~800 kcal, 50% fat) resulted in a decrease in tenofovir alafenamide Cmax (15-37%) and an increase in AUClast (17-77%).
U odnosu na stanje natašte, primjena tenofoviralafenamida s visokomasnim obrokom (~800 kcal, 50% masti) uzrokovala je smanjenje Cmax (15-37%) i povećanje AUCzadnji (17-77%) tenofoviralafenamida.
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 these events can occur many months after initiation of treatment.
Autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa) također su zabilježeni u sklopu imunološke reaktivacije; međutim, prijavljeno vrijeme do nastupa poremećaja više varira i ti događaji mogu se pojaviti puno mjeseci nakon početka liječenja.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Tenofoviralafenamid nije inhibitor ljudske uridin-difosfat-glukuronoziltransferaze (UGT) 1A1 in vitro.
On days of haemodialysis, Descovy should be administered after completion of haemodialysis treatment.
Na dane hemodijalize, Descovy treba primijeniti nakon završetka postupka hemodijalize.
The mean age was 58 years (range: 24-82), with 63 patients (26%) who were ≥ 65 years of age.
Srednja vrijednost dobi bila je 58 godina (raspon: 24-82), sa 63 bolesnika (26%) u dobi ≥ 65 godina.
Do not breast-feed during treatment with Descovy.
Nemojte dojiti tijekom liječenja lijekom Descovy.
Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with or without food Do not chew, crush or split the tablet.
Adolescenti u dobi od 12 godina i stariji, koji imaju tjelesnu težinu najmanje 35 kg: jedna tableta svaki dan, s hranom ili bez nje.
1 With the exception of angioedema, anaemia and urticaria (see footnotes 2, 3 and 4), all adverse reactions were identified from clinical studies of F/TAF containing products.
1 Osim angioedema, anemije i urtikarije (vidjeti podnožne bilješke 2, 3 i 4), sve su nuspojave bile utvrđene u kliničkim ispitivanjima lijekova koji sadrže F/TAF.
Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48.
Od bolesnika koji su na početku bili HBeAg pozitivni, 1/30 (3,3%) postiglo je serokonverziju u anti-HBe u 48. tjednu.
PI = protease inhibitor a Week 48 window was between Day 294 and 377 (inclusive).
IP = inhibitor proteaze a Okvir 48. tjedna bio je između 294. i 377. dana (uključivo).
Discontinuation of Descovy therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekid terapije lijekom Descovy u bolesnika istodobno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
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 bolešću jetre ili cirozom jetre prekid liječenja može dovesti do pogoršanja hepatitisa, što može biti opasno po život.
Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of Descovy.
Toksičnost za kost uočena je kao smanjeni BMD u štakora i pasa pri izloženostima tenofoviru najmanje četiri puta većima od onih očekivanih nakon primjene lijeka Descovy.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 μg/mL.
In vitro vezanje emtricitabina za humane proteine plazme bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02-200 µg/ml.
Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs Week 48.
Od bolesnika koji su na početku bili HBsAg pozitivni, 3/70 (4,3%) postiglo je serokonverziju u anti-HBs u 48. tjednu.
• herbal remedies used to treat depression and anxiety containing: St. John's wort (Hypericum perforatum)
• biljne lijekove, primjenjuju se za liječenje depresije i tjeskobe, a koji sadržavaju: gospinu travu (Hypericum perforatum)
Descovy blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply.
Descovy koči djelovanje enzima reverzne transkriptaze koji je nužan za umnažanje virusa.
Patients with HIV-1 harbouring mutations
Bolesnici s HIV-1 koji nosi mutacije
When your supply of Descovy starts to run low, get more from your doctor or pharmacist.
Kad Vam se smanji zaliha lijeka Descovy, nabavite još lijeka od liječnika ili ljekarnika.
The adverse reactions in Table 3 are listed by system organ class and frequency.
Nuspojave u Tablici 3 navedene su prema klasifikaciji organskih sustava i učestalosti.
No dose adjustment of Descovy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Nije potrebna prilagodba doze lijeka Descovy u odraslih ili adolescenata (u dobi od najmanje 12 godina i s tjelesnom težinom od najmanje 35 kg) s procijenjenim klirensom kreatinina (CrCl) ≥ 30 ml/min.
Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1) (see sections 4.2 and 5.1).
Lijek Descovy je indiciran u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje odraslih osoba i adolescenata (u dobi od 12 godina i starijih, s tjelesnom težinom od najmanje 35 kg) zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) (vidjeti dijelove 4.2 i 5.1).
The safety profile in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Sigurnosni profil u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega bio je sličan onome u bolesnika s normalnom funkcijom bubrega (vidjeti dio 5.1).
Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Tenofoviralafenamid nije inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6 in vitro.
The co-administration of Descovy is not recommended with certain anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g., rifampicin, rifabutin, rifapentine), St. John's wort and HIV protease inhibitors (PIs) other than atazanavir, lopinavir and darunavir (see section 4.5).
Ne preporučuje se istodobna primjena lijeka Descovy s određenim antikonvulzivima (npr. karbamazepinom, okskarbazepinom, fenobarbitalom i fenitoinom), antimikobakterijskim lijekovima (npr. rifampicinom, rifabutinom, rifapentinom), gospinom travom i inhibitorima proteaze HIV-a osim atazanavirom, lopinavirom i darunavirom (vidjeti dio 4.5).
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, or tenofovir alafenamide.
Klinički značajne farmakokinetičke razlike vezane uz dob, spol ili etničku pripadnost nisu ustanovljene za emtricitabin ili tenofoviralafenamid.
Dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir
Descovy 200/25 mg jedanput na dan dolutegravir, efavirenz, maravirok, nevirapin, rilpivirin, raltegravir
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/μL, 50-199 cells/μL, or ≥ 200 cells/μL), and by region (US or ex-US).
b U oba ispitivanja bolesnici su stratificirani prema početnoj HIV-1 RNK (≤ 100 000 kopija/ml, > 100 000 kopija/ml do ≤ 400 000 kopija/ml, ili > 400 000 kopija/ml), prema broju CD4+ stanica (< 50 stanica/µl, 50-199 stanica/µl ili ≥ 200 stanica/µl) te po regiji (SAD ili izvan SAD-a).
• If you notice 18 hours or more after the time you usually take Descovy, then do not take the missed dose.
• Ako to primijetite kada je prošlo 18 sati ili više od propuštene doze lijeka Descovy, onda nemojte uzeti propuštenu dozu.
The safety profile of emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in 50 adolescent patients was similar to that in adults (see section 5.1).
Sigurnosni profil emtricitabina i tenofoviralafenamida davanih s elvitegravirom i kobicistatom u 50 adolescentnih bolesnika bio je sličan onome u odraslih (vidjeti dio 5.1).
Tenofovir alafenamide exposure is not expected to be affected by maraviroc, nevirapine or raltegravir, nor is it expected to affect the metabolic and excretion pathways relevant to maraviroc, nevirapine or raltegravir.
nevirapin ili raltegravir utjecati na izloženost tenofoviralafenamidu, niti se očekuje da će izloženost tenofoviralafenamidu utjecati na metaboličke puteve i puteve izlučivanja važne za maravirok, nevirapin ili raltegravir.
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Za praćenje lipida i glukoze u krvi preporučuje se slijediti utvrđene smjernice za liječenje HIV-a.
If a patient misses a dose of Descovy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Ako je od propuštene doze prošlo više od 18 sati, bolesnik ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati doze prema uobičajenom rasporedu.
In a study in virologically suppressed adult patients measures of tubular proteinuria were similar in patients switching to a regimen containing Descovy compared to patients who stayed on an abacavir/lamivudine containing regimen at baseline.
U ispitivanju u odraslih bolesnika kod kojih je virus bio suprimiran, mjere tubularne proteinurije bile su slične u bolesnika prebačenih na režim koji sadrži lijek Descovy u usporedbi s bolesnicima koji su ostali na početnom režimu koji sadrži abakavir/lamivudin.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 μg/mL.
In vitro vezanje tenofovira za humane proteine plazme je < 0,7% i ne ovisi o koncentraciji u rasponu od 0,01-25 µg/ml.
Race Black Non-black
Spol Muški Ženski Rasa Crnci
At Week 48, the median percentage change in urine retinol binding protein to creatinine ratio was 4% in the Descovy group and 16% in those remaining on an abacavir/lamivudine containing regimen; and in urine beta-2 microglobulin to creatinine ratio it was 4% vs. 5%.
U 48. tjednu, medijan postotka promjene omjera proteina koji veže retinol i kreatinina u mokraći iznosio je 4% u skupini koja je primala Descovy i 16% u onih koji su ostali na režimu koji sadrži abakavir/lamivudin; a omjera beta-2 mikroglobulina i kreatinina u mokraći iznosio je 4% naspram 5%.
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Tenofovir se eliminira bubrezima i putem glomerularne filtracije i aktivne tubularne sekrecije.
Fluconazole Isavuconazole
Flukonazol Izavukonazol
Multinucleoside-resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide.
HIV-1 rezistentan na više nukleozidnih lijekova s mutacijom dvostrukim umetanjem T69S ili kompleksom mutacija Q151M uključujući K65R pokazao je smanjenu osjetljivost na tenofoviralafenamid.
Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 3,112 HIV-1 infected patients received medicinal products containing emtricitabine and tenofovir alafenamide and from post-marketing experience.
Procjena nuspojava temelji se na podacima o sigurnosti iz svih ispitivanja faze 2 i 3 u kojima je 3112 bolesnika zaraženih virusom HIV-1 primalo lijekove koji sadrže emtricitabin i tenofoviralafenamid te iz razdoblja nakon stavljanja u promet.
EU/1/16/1099/001 EU/1/16/1099/002
EU/1/16/1099/002
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
≤ 100 000 kopija/ml > 100 000 kopija/ml
Descovy 200 mg/10 mg [Outer packaging only]
Descovy 200 mg/10 mg [samo vanjsko pakiranje]
In animal studies there were no effects of emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).
U ispitivanjima na životinjama nije bilo učinaka emtricitabina i tenofoviralafenamida na parenje ili parametre plodnosti (vidjeti dio 5.3).
Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food.
Primjena emtricitabina s hranom nije utjecala na sistemsku izloženost emtricitabinu.
The frequencies were derived from Phase 3 E/C/F/TAF clinical studies in 866 treatment-naïve adult patients through 144 weeks of treatment (GS-US-292-0104 and GS-US-292-0111).
Učestalosti su izvedene iz podataka faze 3 kliničkih ispitivanja E/C/F/TAF-a tijekom 144 tjedna liječenja 866 odraslih bolesnika koji prethodno nisu bili liječeni (GS-US-292-0104 i GS-US-292-0111).
The recommended dose of Descovy is 200/10 mg once daily.
Preporučena doza lijeka Descovy je 200/10 mg jedanput na dan.
a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102) b n = 23 adolescents (GS-US-292-0106, population PK analysis) c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis)
Podaci su prikazani kao srednja vrijednost (% CV) a n = 24 adolescenta (GS-US-292-0106); n = 19 odraslih (GS-US-292-0102) b n = 23 adolescenta (GS-US-292-0106, populacijska farmakokinetička analiza) c n = 539 (TAF) ili 841 (TFV) odraslih (GS-US-292-0111 i GS-US-292-0104, populacijska farmakokinetička analiza)
The recommended dose of Descovy is 200/25 mg once daily.
Preporučena doza lijeka Descovy je 200/25 mg jedanput na dan.
If you vomit less than 1 hour after taking Descovy, take another tablet.
Ako povratite unutar 1 sata od uzimanja lijeka Descovy, uzmite drugu tabletu.