natgillin/translations-raw huggingface dataset:
f n = 539 (TAF) or 841 (TFV) adults.
b n = 22 djece c n = 20 djece d AUClast e n = 19 odraslih f n = 539 (TAF) ili 841 (TFV) odraslih
4 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate.
To je ispitivanje provedeno pomoću elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksilfumarata.
Reproductive toxicity studies in rats and rabbits with cobicistat showed no effects on mating, fertility, pregnancy or foetal parameters.
Ispitivanja reproduktivne toksičnosti na štakorima i kunićima s kobicistatom nisu pokazala učinke na parenje, plodnost, trudnoću i fetalne parametre.
Concentrations of voriconazole may increase or decrease when co-administered with Genvoya.
Koncentracije vorikonazola mogu se povećati ili smanjiti s istodobnom primjenom lijeka Genvoya.
Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/
voksilaprevir (400 mg/100 mg/100 mg+100 mg jedanput na dan)7/
Animal studies do not indicate direct or indirect harmful effects of elvitegravir, cobicistat, or emtricitabine, administered separately, with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Ispitivanja na životinjama u kojima su elvitegravir, kobicistat ili emtricitabin primijenivani odvojeno ne ukazuju na izravan ili neizravan štetan učinak na parametre plodnosti, trudnoću, razvoj fetusa, okot ili postnatalni razvoj.
Female
Kobicistat
At baseline, median CD4+ cell count was 969 cells/mm3 (range: 603 to 1,421), and median CD4+% was 39% (range: 30 to 51%).
Na početku, medijan broja CD4+ stanica bio je 969 stanica/mm3 (raspon: 603 do 1421), a medijan postotka CD4+ bio je 39% (raspon: 30-51%).
At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was ~4.0.
Pri vršnoj koncentraciji u plazmi omjer srednje vrijednosti lijeka u plazmi i koncentracije lijeka u krvi iznosio je ~1,0, a omjer srednje vrijednosti koncentracije lijeka u spermi i koncentracije lijeka u plazmi iznosio je ~4,0.
The mean baseline CD4+ cell count was 697 cells/mm3 (range 79-1,951).
Srednja vrijednost početnog broja CD4+ stanica bila je 697 stanica/mm3 (raspon 79-1951).
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product.
Istodobna primjena lijeka Genvoya može za posljedicu imati povećane koncentracije ovog lijeka u plazmi.
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Genvoya 150 mg/150 mg/200 mg/10 mg filmom obložene tablete elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid
Concentrations of beta-blockers may be increased when co-administered with cobicistat.
Koncentracije beta-blokatora mogu se povećati s istodobnom primjenom kobicistata.
After switching to Genvoya, 90% (45/50) of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
Nakon prelaska na liječenje lijekom Genvoya, 90% (45/50) bolesnika zadržalo je razinu supresije (HIV-1 RNK < 50 kopija/ml) u 48. tjednu.
The mean age was 50 years (range 28-67), 92% of patients were male, 69% were White, 18% were Black, and 10% were Asian.
Srednja vrijednost dobi je 50 godina (raspon od 28 do 67), 92% bolesnika bili su muškarci, 69% bijelaca, 18% crnaca i 10% azijata.
Gilead Sciences Ireland UC Carrigtohill
Nositelj odobrenja za stavljanje lijeka u promet Gilead Sciences Ireland UC Carrigtohill
In Study GS-US-292-1825, the efficacy and safety of Genvoya were evaluated in a single-arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to Genvoya.
U otvorenom kliničkom ispitivanju GS-US-292-1825, djelotvornost i sigurnost lijeka Genvoya procijenjene su u jednoj skupini od 55 odraslih osoba zaraženih virusom HIV-1 sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) na kroničnoj hemodijalizi tijekom najmanje 6 mjeseci prije prebacivanja na lijek Genvoya.
The safety of Genvoya was evaluated through 48 weeks in HIV-1 infected adolescent patients between the ages of 12 to < 18 years weighing ≥ 35 kg, who were either treatment-naïve (GS-US-292-0106, n = 50), or who were virologically suppressed (GS-US-292-1515, n = 50), and in virologically suppressed children between the ages of 8 to < 12 years weighing > 25 kg (GS-US-292-0106, n = 23).
Pedijatrijska populacija Sigurnost lijeka Genvoya u adolescenata u dobi od 12 do < 18 godina s tjelesnom težinom ≥ 35 kg zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (GS-US-292-0106, n = 50) ili su imali virološku supresiju (GS US 292-1515, n = 50), te u djece s virološkom supresijom u dobi od 8 do < 12 godina s tjelesnom težinom > 25 kg (GS-US-292-0106, n = 23), procijenjena je tijekom
Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity.
- slabost mišića - slabost koja počinje u šakama i stopalima i pomiče se nagore prema trupu tijela - osjećaj lupanja srca, nevoljnog drhtanja ili hiperaktivnosti
Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients Elvitegravir-resistant viruses show varying degrees of cross-resistance to the INSTI raltegravir depending on the type and number of mutations.
Virusi rezistentni na elvitegravir pokazuju različit stupanj križne rezistencije za INSTI raltegravir ovisno o tipu i broju mutacija.
Lactose (as monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulfate Magnesium stearate
Jezgra tablete laktoza (u obliku hidrata) mikrokristalična celuloza umrežena karmelozanatrij hidroksipropilceluloza silicijev dioksid natrijev laurilsulfat magnezijev stearat
• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole
• lijekove protiv gljivica, primjenjuju se za liječenje gljivičnih infekcija, kao što su: ketokonazol, itrakonazol, vorikonazol, posakonazol i flukonazol
However, based on the information retrieved in literature and in the product information of integrase inhibitors containing medicinal products, it could be concluded that the following psychiatric disorders: depression, suicidal ideation and suicidal behaviour (particularly in patients with pre-existing history of psychiatric illness) are class-effect of integrase inhibitors and these are listed in the SmPC of other medicinal products containing integrase inhibitors in monotherapy and in fixed-dose combination (FDC).
Međutim, na temelju informacija pronađenih u literaturi i informacija o lijeku lijekova koji sadrže inhibitore integraze, moglo bi se zaključiti da su sljedeći psihijatrijski poremećaji: depresija, suicidalne ideacije i suicidalno ponašanje
• PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension
• inhibitori PDE-5: sildenafil za liječenje plućne arterijske hipertenzije • sedativi/hipnotici: midazolam peroralno primijenjen, triazolam.
How to take Genvoya
Kako uzimati lijek Genvoya
ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
RECEPTORA Bosentan
Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Emtricitabin je pokazao antivirusnu aktivnost u staničnoj kulturi na podtipove virusa HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i specifičnu aktivnost na sojeve virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).
dyspepsia
dispepsija
The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Srednja vrijednost početnog broja CD4+ stanica iznosila je 664 stanica/mm3 (raspon 126-1813).
• tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
• tenofoviralafenamid, antiretrovirusni lijek poznat kao nukleotidni inhibitor reverzne transkriptaze (NtRTI).
Clinical monitoring is recommended due to the potential for hyperkalaemia.
Zbog moguće pojave hiperkalijemije preporučuje se kliničko praćenje.
4.2% (95% CI: 0.6% to 7.8%)
4,2% (95% CI: 0,6% do 7,8%)
Plasma concentrations of drospirenone may be increased when co-administered with cobicistat-containing products.
Koncentracije drospirenona u plazmi mogu se povećati s istodobnom primjenom lijekova koji sadrže kobicistat.
Do not store the split tablet.
Lomljene tablete nemojte čuvati.
Triazolam is primarily metabolised by CYP3A.
Triazolam prvenstveno metabolizira CYP3A.
Talk to your doctor before taking Genvoya: • If you have liver problems or a history of liver disease, including hepatitis.
• Ako imate tegobe s jetrom ili ste imali bolest jetre, uključujući hepatitis.
Intravenously administered midazolam (1 mg single dose)/ Tenofovir alafenamide (25 mg once daily)
Midazolam primijenjen intravenski (jedna doza od 1 mg)/ tenofoviralafenamid (25 mg jedanput na dan)
Midazolam is primarily metabolised by CYP3A.
Midazolam prvenstveno metabolizira CYP3A.
The mean change from baseline in CD4+ cell count and percentage at Week 48 was -90 cells/mm3 and -1.3%, respectively.
Srednja vrijednost promjene od početnog broja i postotka CD4+ stanica u 48. tjednu bila je -90 stanica/mm3 odnosno -1,3%.
Recommendation concerning co-administration with Genvoya
Preporuka za istodobnu primjenu s lijekom Genvoya
Co-administration of Genvoya with carbamazepine is contraindicated (see section 4.3).
Istodobna primjena lijeka Genvoya s karbamazepinom je kontraindicirana (vidjeti dio 4.3).
Table 5: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Tablica 5. Farmakokinetika elvitegravira, kobicistata, emtricitabina, tenofovira i tenofoviralafenamida u adolescenata i odraslih koji prethodno nisu bili liječeni antiretrovirusnim lijekovima
Atorvastatin: AUC: ↑ 160% Cmin: NC Cmax: ↑ 132%
AUC: ↑160% Cmin: NC Cmax: ↑132%
FTC/tenofovir disoproxil plus boosted atazanavir E/C/F/TDF
FTC/tenofovirdizoproksil plus pojačani atazanavir
The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm3.
Srednja vrijednost porasta od početnog broja CD4+ stanica u 48. tjednu bila je 224 stanica/mm3.
HIV-1 infected virologically suppressed patients
Bolesnici zaraženi virusom HIV-1 kod kojih je virus suprimiran
Patients with CrCl between 30 mL/min and 60 mL/min:
60 ml/min:
Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Genvoya.
Koncentracije ketokonazola i/ili kobicistata mogu se povećati s istodobnom primjenom lijeka Genvoya.
Ketoconazole (200 mg twice daily)/ Elvitegravir (150 mg once daily)2
Ketokonazol (200 mg dvaput na dan)/elvitegravir (150 mg jedanput na dan)2
The safety of Genvoya in 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112).
Sigurnost lijeka Genvoya u 248 bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (n = 6) ili im je virus bio suprimiran (n = 242) s blagim do umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije Cockcroft-Gaultovom metodom [eGFRCG]: 30-69 ml/min)
At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
U 48. tjednu, HIV-1 RNK < 50 kopija/ml zadržala se u 81,8% (45/55 bolesnika) nakon prebacivanja na lijek Genvoya.
Orally administered midazolam (2.5 mg single dose)/ Tenofovir alafenamide (25 mg once daily)
Midazolam primijenjen peroralno (jedna doza od 2,5 mg)/ tenofoviralafenamid (25 mg jedanput na dan)
It is not known whether elvitegravir, cobicistat, or tenofovir alafenamide are excreted in human milk.
Nije poznato izlučuju li se elvitegravir, kobicistat ili tenofoviralafenamid u majčino mlijeko.
Sofosbuvir metabolite GS-331007:
Metabolit sofosbuvira GS-331007: AUC: ↑ 43%
HIV-1 RNA < 50 copies/mL Treatment difference
HIV-1 RNK < 50 kopija/ml Razlika u liječenju
Caution should be exercised when co-administering Genvoya and a hormonal contraceptive.
Istodobna primjena lijeka Genvoya i hormonske kontracepcije mora se provoditi s oprezom.
The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Djelatne tvari su elvitegravir, kobicistat, emtricitabin i tenofoviralafenamid.
In Study GS-US-292-0109, the efficacy and safety of switching from either efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil, FTC/tenofovir disoproxil plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to Genvoya were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 1,436).
U randomiziranom, otvorenom ispitivanju GS-US-292-0109 procjenjivane su djelotvornost i sigurnost prebacivanja odraslih bolesnika (n = 1436) zaraženih virusom HIV-1 kod kojih je virus bio suprimiran (HIV-1 RNK < 50 kopija/ml) bilo sa režima efavirenz (EFV)/emtricitabin (FTC)/tenofovirdizoproksil, FTC/tenofovirdizoproksil plus atazanavir (pojačan ili kobicistatom ili ritonavirom) ili E/C/F/TDF na režim s lijekom Genvoya.
No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between patients with moderate hepatic impairment and subjects with normal hepatic function.
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira i kobicistata između bolesnika s umjerenim oštećenjem funkcije jetre i ispitanika s normalnom funkcijom jetre.
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol (E1521) Talc (E553b)
Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171)
FOOD SUPPLEMENTS Multivitamin supplements
Multivitaminski dodaci
Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)6
Norgestimat (0,180/0,215/0,250 mg jedanput na dan)/etinilestradiol (0,025 mg jedanput na dan)/ emtricitabin/tenofoviralafenamid (200/25 mg jedanput na dan)6
Based on non-CYP-mediated elimination pathways for lorazepam, no effect on plasma concentrations is expected upon co-administration with Genvoya.
CYP-om, ne očekuje se učinak na koncentracije u plazmi nakon istodobne primjene s lijekom Genvoya.
(38.9)b N/A
(38,9)b
The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Tenofoviralafenamid je pokazao antivirusnu aktivnost u staničnoj kulturi na sve skupine virusa HIV-1 (M,N i O), uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,10 do 12,0 nM) i specifičnu aktivnost na sojeve HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
Genvoya demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
U usporedbi sa skupinom E/C/F/TDF, lijek Genvoya pokazao je statističku superiornost u postizanju vrijednosti HIV-1 RNK < 50 kopija/ml u 144. tjednu.
How to store Genvoya
Kako čuvati lijek Genvoya
Caution is warranted and clinical monitoring is recommended during the co-administration.
U slučaju istodobne primjene preporučuju se mjere opreza i klinički nadzor.
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.4 and 4.6).
Stoga se terapija lijekom Genvoya ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije lijekom Genvoya treba prebaciti na drugi režim (vidjeti dijelove 4.4 i 4.6).
ANTIARRHYTHMICS Digoxin (0.5 mg single dose)/ Cobicistat (150 mg multiple doses)
Digoksin (jedna doza od 0,5 mg)/
Concentrations of these immunosuppressant agents may be increased when administered with cobicistat.
Koncentracije ovih imunosupresiva mogu se povećati s istodobnom primjenom kobicistata.
cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (when used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
• ako uzimate jedan od sljedećih lijekova: alfuzozin (primjenjuje se za liječenje povećane prostate) dabigatran (primjenjuje se za sprječavanje i liječenje krvnih ugrušaka) amiodaron, kinidin (primjenjuju se za ispravljanje nepravilnih otkucaja srca) karbamazepin, fenobarbital, fenitoin (primjenjuju se za sprječavanje napadaja) rifampicin (primjenjuje se za sprječavanje i liječenje tuberkuloze i drugih infekcija) dihidroergotamin, ergometrin, ergotamin (primjenjuju se za liječenje migrene) cisaprid (primjenjuje se za ublažavanje određenih želučanih tegoba) gospina trava (Hypericum perforatum, biljni lijek koji se primjenjuje za depresiju i tjeskobu) ili lijekovi koji je sadrže lovastatin, simvastatin (primjenjuju se za snižavanje kolesterola u krvi) pimozid, lurasidon (primjenjuje se za liječenje abnormalnih misli i osjećaja) sildenafil (kad se primjenjuje za liječenje plućne arterijske hipertenzije - bolest pluća koja otežava disanje) midazolam peroralno primijenjen, triazolam (pomaže Vam da zaspete i/ili za ublažavanje tjeskobe)
• adefovir dipivoxil
• omaglica • proljev
Co-administration of Genvoya and triazolam is contraindicated (see section 4.3).
Istodobna primjena lijeka Genvoya i triazolama je kontraindicirana (vidjeti dio 4.3).
Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL Baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
≤ 100 000 kopija/ml > 100 000 kopija/ml
No dose adjustment of buprenorphine/naloxone is required.
Prilagodba doze buprenorfina/naloksona nije potrebna.
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.2 and 4.6).
Stoga terapija lijekom Genvoya ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije lijekom Genvoya treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.6).
Concentrations of clarithromycin and/or cobicistat may be altered with co-administration of Genvoya.
Koncentracije klaritromicina i/ili kobicistata mogu se izmijeniti s istodobnom primjenom lijeka Genvoya.
Cmax, Cmin1
Srednja vrijednost postotka promjene AUC, Cmax, Cmin1
Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.2 and 4.4).
Stoga terapija lijekom Genvoya ne smije započeti tijekom trudnoće, a žene koje zatrudne za vrijeme terapije lijekom Genvoya treba prebaciti na drugi režim (vidjeti dijelove 4.2 i 4.4).
Due to the presence of cobicistat, co-administration with Genvoya may result in increased plasma concentrations of this medicinal product, which is associated with the potential for serious or life-threatening adverse reactions.
Zbog prisutnosti kobicistata, istodobna primjena s lijekom Genvoya može za posljedicu imati povećane koncentracije ovog lijeka u plazmi, što je povezano s potencijalno ozbiljnim ili životno opasnim nuspojavama.
No clinically relevant differences in elvitegravir, cobicistat, or tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Nisu opažene klinički važne razlike u farmakokinetici elvitegravira, kobicistata ili tenofoviralafenamida između bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi i onih s normalnom funkcijom bubrega.
It is recommended that digoxin levels be monitored when digoxin is combined with Genvoya.
Prilikom kombinacije digoksina i lijeka Genvoya preporučuje se nadzor razina digoksina.
Norgestimate (0.180/0.215 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)4
Norgestimat (0,180/0,215 mg jedanput na dan)/etinilestradiol (0,025 mg jedanput na dan)/ elvitegravir (150 mg jedanput na dan)/kobicistat (150 mg jedanput na dan)4
Concentrations of pitavastatin may be increased when administered with elvitegravir and cobicistat.
Koncentracije pitavastatina mogu se povećati s istodobnom primjenom elvitegravira i kobicistata.
Caution should be exercised when co-administering Genvoya with pitavastatin.
Genvoya i pitavastatina mora se provoditi s oprezom.
Clinical monitoring is recommended upon co-administration of Genvoya.
Klinički nadzor preporučuje se kod istodobne primjene lijeka Genvoya.
Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 µg ethinyloestradiol and containing drospirenone or norgestimate as the progestogen or should use an alternative reliable method of contraception (see sections 4.5 and 4.6).
30 µg etinilestradiola i drospirenon ili norgestimat kao progestagen ili moraju primjenjivati drugu pouzdanu metodu kontracepcije (vidjeti dijelove 4.5 i 4.6).
The mean change from baseline in CD4+ cell count and percentage at Week 48 was -43 cells/mm3 and -0.1%, respectively.
Srednja vrijednost promjene od početnog broja i postotka CD4+ stanica u 48. tjednu bila je -43 stanica/mm3 odnosno -0,1%.
Concentrations of these antiarrhythmic drugs may be increased when co-administered with cobicistat.
Koncentracije tih antiaritmika mogu se povećati s istodobnomprimjenom kobicistata.
Co-administration with Genvoya may result in increased plasma concentrations of salmeterol, which is associated with the potential for serious or life-threatening adverse reactions.
Istodobna primjena lijeka Genvoya može za posljedicu imati povećane koncentracije salmeterola u plazmi, što je povezano s potencijalno ozbiljnim ili životno opasnim nuspojavama.
In virologically suppressed patients
U bolesnika kod kojih je virus suprimiran
Cockcroft-Gault method, and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF (see also section 4.4).
U ispitivanjima u bolesnika koji prethodno nisu bili liječeni, lijek Genvoya bio je povezan s manjim utjecajem na parametre sigurnosti primjene za bubrege (mjereno nakon 144 tjedna liječenja prema procijenjenoj brzini glomerularne filtracije Cockcroft-Gaultovom metodom i omjerom proteina i kreatinina u mokraći, te nakon 96 tjedana liječenja omjerom albumina i kreatinina u mokraći) u usporedbi s E/C/F/TDF (vidjeti također dio 4.4).
The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Srednja vrijednost početnog broja stanica CD4+ bio je 636 stanica/mm3 (u rasponu od 263 do 1498).
HIV-1 RNA ≥ 50 copies/mLd
HIV-1 RNK < 50 kopija/ml
AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
25-O-dezacetilrifabutin AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
{MM/YYYY}
SN: {broj}
Concentrations of antidepressant agents may be increased when co-administered with cobicistat.
Koncentracije antidepresiva mogu se povećati pri istodobnoj primjeni s kobicistatom.
Concentrations of sertraline are not affected upon co-administration with Genvoya.
Istodobna primjena s lijekom Genvoya ne utječe na koncentracije sertralina.
AUC: ↔ Cmin: ↓ 66% Cmax: ↔
Kobicistat: AUC: ↔ Cmin: ↓ 66% Cmax: ↔
Genvoya [Outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Genvoya [samo vanjsko pakiranje]