natgillin/translations-raw huggingface dataset:
Concomitant use of Symtuza may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Sočasna uporaba zdravila Symtuza lahko poveča tveganje za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvične žleze.
Based on animal studies, no effect on reproduction or fertility is expected with Symtuza.
Na osnovi študij na živalih ni pričakovati, da bi zdravilo Symtuza vplivalo na sposobnost razmnoževanja ali plodnost.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
V primeru prevelikega odmerjanja, je treba bolnika opazovati glede znakov toksičnosti (glejte poglavje 4.8).
There was no effect on mating or fertility in animals (see section 5.3).
Pri živalih te učinkovine niso vplivale na parjenje ali plodnost (glejte poglavje 5.3).
111-1921 x 10
3 (od 111 do 1921 x 10
Symtuza, therefore, must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3 or table below).
Zato se zdravila Symtuza ne sme uporabljati v kombinaciji z zdravili, katerih očistek je močno odvisno od CYP3A, povečana sistemska izpostavljenost tem zdravilom pa je povezana z resnimi in/ali življenjsko nevarnimi dogodki (imajo ozko terapevtsko okno) (glejte poglavje 4.3 ali spodnjo preglednico).
Patients were allowed in the study if they had previous failure on any non-darunavir ARV regimen.
Bolnike so lahko vključili v študijo, če je pri njih prej prišlo do neuspeha zdravljenja s katerim od protiretrovirusnih režimov, ki niso vsebovali darunavirja.
Darunavir is primarily metabolised and eliminated by the liver.
Darunavir se presnavlja in izloča predvsem skozi jetra.
Third trimester of pregnancy N = 6
Tretje trimesečje nosečnosti (n=6)
Therapeutic drug monitoring of voriconazole, posaconazole or itraconazole is recommended.
Priporočljivo je spremljanje terapevtskih koncentracij vorikonazola, posakonazola oziroma itrakonazola.
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 analiza farmakokinetike pri bolnikih okuženih s HIV je pokazala, da farmakokinetika darunavirja ni bistveno drugačna v razponu starosti, ki so ga preučevali pri bolnikih, okuženih s HIV (od 18 do 75 let) (n = 12, starost  65 let) (glejte poglavje 4.4).
If Symtuza is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Če je treba zdravilo Symtuza uporabljati sočasno s parenteralno obliko midazolama, ju je treba odmerjati na oddelku intenzivne terapije ali v podobni enoti, kar zagotavlja skrbno spremljanje bolnika in ustrezno zdravljenje v primeru depresije dihanja in/ali dolgotrajne sedacije.
The safety and efficacy of Symtuza in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Varnost in učinkovitost zdravila Symtuza pri bolnikih, s sočasno okužbo z virusom HIV-1 in z virusom hepatitisa C, nista bili dokazani.
• a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung].
• reakcija, ki jo imenujemo DRESS [hud izpuščaj, ki ga včasih spremljajo zvišana telesna temperatura, utrujenost, otekanje obraza in bezgavk, povečano število eozinofilcev (oblika belih krvnih celic) in učinki na jetra, ledvica ali pljuča].
Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Pokazalo se je, da lahko nukleozidni in nukleotidni analogi in vitro in in vivo povzročijo različne stopnje okvare mitohondrijev.
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.
Priporočeni odmerek za odrasle in mladostnike, ki so stari 12 let ali več, s telesno maso vsaj 40 kg, je ena tableta vsak dan s hrano.
Prior data with ritonavir-boosted darunavir however showed a decrease in these anti-depressant plasma concentrations (unknown mechanism); the latter may be specific to ritonavir.
Predhodni podatki o uporabi darunavirja, okrepljenega z ritonavirjem kažejo, da je prišlo do zmanjšanja plazemskih koncentracij navedenih antidepresivov (mehanizem ni znan), kar je verjetno specifično za ritonavir.
It is not known whether the co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g. febuxostat) would increase systemic exposure to tenofovir.
Ni znano, ali sočasna uporaba alafenamidtenofovirata in zaviralcev ksantin oksidaze (npr. febuksostata) lahko poveča sistemsko izpostavljenost tenofovirju.
The data from these studies showed that the overall safety profile of components of Symtuza in paediatric patients aged 12 to < 18 years and weighing at least 40 kg was similar to that observed in the adult population (see section 5.1).
Po podatkih teh študij je skupen varnostni profil učinkovin zdravila Symtuza pri pediatričnih bolnikih, ki so stari 12 do < 18 let in s telesno maso najmanj 40 kg, podoben tistemu, ki so ga opažali pri odraslih (glejte poglavje 5.1).
Medicinal products that strongly affect P-gp activity and BCRP may lead to changes in tenofovir alafenamide absorption.
Zdravila, ki močno vplivajo na aktivnost P-glikoproteina in BCRP, lahko vplivajo na absorpcijo alafenamidtenofovirata.
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.
Sočasna uporaba emtricitabina z zdravili, ki se izločajo z aktivno tubulno sekrecijo, lahko poveča koncentracijo emtricitabina in/ali sočasno uporabljenih zdravil.
In vitro studies indicate that emtricitabine is not an inhibitor of human CYP enzymes.
Rezultati študij in vitro kažejo, da emtricitabin pri človeku ni zaviralec encimov CYP.
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets
Symtuza 800 mg/150 mg/200 mg/10 mg filmsko obložene tablete
your doctor may have to check your blood.
Zdravnik vas bo morda moral napotiti na krvne preiskave.
If concomitant use of Symtuza with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Če je indicirana sočasna uporaba zdravila Symtuza in sildenafila, vardenafila ali tadalafila, je priporočljivo uporabiti sildenafil v enkratnem odmerku največ 25 mg v 48 urah, vardenafil v enkratnem odmerku največ 2,5 mg v 72 urah, tadalafil pa v enkratnem odmerku največ 10 mg v 72 urah.
A long term carcinogenicity study of cobicistat in rats revealed tumourigenic potential specific for this species, that is regarded as of no relevance for humans.
Dolgoročne študije kancerogenosti kobicistata na podganah so pokazale kancerogeni potencial, ki je specifičen za navedeno vrsto, za ljudi pa naj ne bi imel pomena.
Based on this limited experience, the safety profile of emtricitabine/tenofovir alafenamide in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection (see section 4.4).
Na osnovi teh omejenih izkušenj kaže, da je varnostni profil kombinacije emtricitabina in alafenamidtenofovirata pri bolnikih s sočasno okužbo z virusom HIV in virusom hepatitisa B podoben kot pri bolnikih, ki imajo samo okužbo z virusom HIV-1 (glejte poglavje 4.4).
C]-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
C označenim darunavirjem in ritonavirjem so pokazali, da se približno 7,7% danega odmerka darunavirja izloči z urinom v nespremenjeni obliki.
Concentrations of these medicinal products may be increased when co-administered with Symtuza resulting in the potential for increased adverse events usually associated with these medicinal products.
Koncentracije navedenih zdravil se lahko pri sočasnem dajanju z zdravilom Symtuza povečajo, kar lahko poveča možnost za neželene učinke, ki se običajno pojavljajo pri uporabi teh zdravil.
The median baseline CD4+ cell count was 628 x 10
Povprečno izhodiščno število celic CD4+ je bilo 628 x 10
ANTACIDS Aluminium/magnesium hydroxide
ANTACIDI aluminijev/magnezijev hidroksid kalcijev karbonat
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.
Rumena do rumenkasto rjava tableta v obliki kapsule velikosti 22 mm x 11 mm, z vtisnjenima oznakama “8121” na eni strani in “JG” na drugi.
ALPHA ADRENORECEPTOR ANTAGONISTS Alfusozin
ANTAGONIST ADRENERGIČNIH RECEPTORJEV ALFA alfuzosin
If switching from ritonavir as a pharmacoenhancer to this regimen with cobicistat, caution is required during the first two weeks of treatment with Symtuza, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir.
Pri prehodu s farmakokinetičnega ojačevalca ritonavirja na kobicistat je prva dva tedna zdravljenja z zdravilom Symtuza potrebna previdnost, zlasti če so bili odmerki sočasno uporabljenega zdravila med zdravljenjem z ritonavirjem titrirani ali prilagojeni.
Some side effects are typical for anti-HIV medicines similar to Symtuza.
Nekateri neželeni učinki so značilni za skupino zdravil proti okužbi z virusom HIV, ki so podobnizdravilu Symtuza.
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.
Ti lahko vključujejo rumenenje kože ali očesnih beločnic, temno obarvan urin (v barvi čaja), svetlo blato (odvajanje blata), slabost, bruhanje, izgubo apetita ali bolečino oziroma občutljivost na desni strani telesa, pod rebri.
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 z odpornostjo na emtricitabin in mutacijo M184M/I/V je bil navzkrižno odporen na lamivudin, vendar je ohranil občutljivost za abakavir, stavudin, tenofovir in zidovudin.
Symtuza reduces HIV-1 in your body and this will improve your immune system (your body's natural defences) and reduce the risk of developing illnesses linked to HIV infection but Symtuza is not a cure for HIV infection.
S tem se vaš imunski sistem (naravna obramba vašega telesa) izboljša in zmanjša se tveganje za razvoj bolezni, povezanih z okužbo s HIV, vendar okužbe z virusom HIV ne odpravi v celoti.
- Colchicine (antigout).
- kolhicin (za zdravljenje putike).
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).
V študijah s predhodno nezdravljenimi bolniki je zdravilo Symtuza le malo vplivalo na ocenjeno hitrost glomerulne filtracije po Cockcroft-Gaultovi formuli v primerjavi s kontrolno skupino (DRV/COBI+F/TDF).
• darunavir, an anti-HIV medicine known as a protease inhibitor
• darunavir, zdravilo proti virusu HIV, znano kot zaviralec proteaze
Tenofovir is eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Tenofovir se izloča iz telesa skozi ledvice z glomerularno filtracijo in z aktivno tubulno sekrecijo.
No pharmacokinetic data are available for emtricitabine and tenofovir alafenamide during pregnancy.
Farmakokinetični podatki za emtricitabin in alafenamidtenofovirat med nosečnostjo niso na voljo.
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Presnova je glavna pot izločanja alafenamidtenofovirata pri človeku in predstavlja > 80% peroralnega odmerka.
ART-experienced patients
Bolniki, z izkušnjami z ART
Symtuza is indicated for use as a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral products (see section 4.5).
Zdravilo Symtuza je indicirano za celovito zdravljenje okužbe z virusom HIV-1 in se ga ne sme dajati sočasno z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
Some patients taking anti-HIV medicines may develop a bone disease called osteonecrosis (bone damage caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki imajo protiretrovirusno zdravljenje, lahko pride do bolezni kosti, ki se imenuje osteonekroza (odmiranje kostnega tkiva, ki je posledica zmanjšane prekrvavitve kosti).
Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Poročali so o nekaterih primerih nevroloških motenj s kasnejšim začetkom (hipertonija, konvulzije, nenormalno vedenje).
Changes in measures of bone mineral density
Spremembe v meritvah mineralne kostne gostote
A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Pri kronični izpostavljenosti majhnim odmerkom tenofovirja zaradi uporabe alafenamidtenofovirata ni mogoče izključiti tveganja za nefrotoksično delovanje (glejte poglavje 5.3).
Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Darunavir se obsežno presnavlja z jetrnim encimskim sistemom CYP, in sicer skoraj izključno z izoencimom CYP3A4.
Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil.
Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po odmerjanju alafenamidtenofovirata v primerjavi z odmerjanjem dizoproksiltenofovirata so študije kancerogenosti in perinatalne ter postnatalne študije na podganah izvedli samo z dizoproksiltenofoviratom.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Izločanje nespremenjenega alafenamidtenofovirata preko ledvic je manj pomembno, saj se z urinom izloči manj kot 1% odmerka.
What Symtuza is and what it is used for What you need to know before you take Symtuza How to take Symtuza
Kaj je zdravilo Symtuza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Symtuza Kako jemati zdravilo Symtuza Možni neželeni učinki
Patients co-infected with HIV and HBV who discontinue Symtuza should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolnike s sočasno okužbo z virusom HIV in virusom hepatitisa B in so prekinili zdravljenje z zdravilom Symtuza, je treba skrbno spremljati tako klinično kot laboratorijsko še najmanj nekaj mesecev po zaključku zdravljenja.
Tenofovir alafenamide is minimally metabolised by CYP3A4.
Alafenamidtenofovirat se v manjši meri presnavlja s CYP3A4.
Patients receiving Symtuza 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.
Pri bolnikih, ki prejemajo zdravilo Symtuza ali katero koli drugo protiretrovirusno zdravilo, lahko še naprej prihaja do oportunističnih okužb in drugih zapletov okužbe z virusom HIV, zato morajo zdravniki z izkušnjami z zdravljenjem bolnikov s HIV in povezanimi okužbami, le te še naprej skrbno klinično spremljati.
Following oral administration of Symtuza, the median terminal elimination half-life of emtricitabine is 17.2 hours.
Po peroralnem odmerjanju zdravila Symtuza je mediani končni razpolovni čas izločanja emtricitabina 17,2 ure.
Concomitant use of PDE-5 inhibitors for the treatment of erectile dysfunction with Symtuza should be done with caution.
Pri sočasni uporabi zdravila Symtuza in zaviralcev PDE-5 za zdravljenje motenj erekcije je potrebna previdnost.
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 najvišji koncentraciji v plazmi je bilo povprečje razmerja med koncentracijo zdravila v plazmi in krvi približno 1,0, povprečje razmerja med koncentracijo zdravila v spermi in plazmi pa je bilo približno 4,0.
- Digoxin (to treat certain heart disorders) - Clarithromycin (antibiotic) - Clotrimazole, fluconazole, Isavuconazole, itraconazole, posaconazole, (for treating fungal infections).
- digoksin (za določene srčne bolezni) - klaritromicin (antibiotik) - klotrimazol, flukonazol, izavukonazol, itrakonazol, posakonazol (za zdravljenje glivičnih okužb).
When used for birth control, non-hormonal contraception methods are recommended.
Če navedena zdravila potrebujete za kontracepcijo, priporočamo uporabo drugih, nehormonskih kontracepcijskih metod.
Since darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Ker se darunavir in kobicistat v veliki meri vežeta na beljakovine v plazmi, ni verjetno, da bi s hemodializo ali peritonealno dializo lahko iz telesa odstranili pomembno količino teh dveh učinkovin.
Symtuza should not be administered concomitantly with medicinal products requiring pharmacokinetic enhancement with ritonavir or cobicistat.
Zdravila Symtuza se ne sme dajati sočasno z zdravili, pri katerih je potrebna farmakokinetična okrepitev z ritonavirjem ali kobicistatom.
• muscle pain, muscle cramps or weakness
• bolečina v mišicah, mišični krči ali šibkost mišic
Tenofovir alafenamide is active against hepatitis B virus (HBV).
Alafenamidtenofovirat deluje proti virusu hepatitisa B.
Human experience of acute overdose with Symtuza is limited.
Izkušnje z akutnim prevelikim odmerjanjem zdravila Symtuza pri ljudeh so omejene.
The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with Symtuza should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Seznam primerov medsebojnega delovanja med posameznimi učinkovinami v spodnji preglednici ni popoln, zato je treba za vsako zdravilo, ki se jemlje sočasno z zdravilom Symtuza, pregledati podatke o poti presnove, interakcijah, morebitnih tveganjih in posebnih ukrepih ob sočasni uporabi.
At Week 96, the median change in eGFRCG was -5.2 mL/min with D/C/F/TAF.
V 96. tednu je bila mediana sprememba eGFRCG v skupini D/C/F/TAF -5,2 ml/min.
The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm
Povprečno povečanje števila celic CD4+ od izhodišča do 48. tedna je bilo 224 celic/mm
If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using Symtuza, interruption or discontinuation of treatment should be considered promptly (see section 5.3).
Če pri bolnikih, ki se zdravijo z zdravilo Symtuza, opazite znake novih ali poslabšanje že obstoječih motenj delovanja jeter (vključno s klinično pomembnim povečanjem koncentracij jetrnih encimov in/ali simptomi, kot so utrujenost, anoreksija, navzea, zlatenica, temno obarvan urin, boleča jetra, hepatomegalija), je nemudoma treba razmisliti o prekinitvi ali ukinitvi zdravljenja (glejte poglavje 5.3).
A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with Symtuza has not been established.
Varnega in učinkovitega odmerka sildenafila za zdravljenje pljučne arterijske hipertenzije skupaj z zdravilom Symtuza niso ugotovili.
Emerging Resistance in AMBER and EMERALD Trial (Week 96)
Pojavljanje odpornosti na zdravila v študijah AMBER in EMERALD (po 96 tednih)
Co-administration with the following medicinal products due to the potential for loss of therapeutic effect (see section 4.5): - carbamazepine, phenobarbital, phenytoin - rifampicin
Sočasno zdravljenje s katerim koli od naslednjih zdravil zaradi možne izgube terapevtskega učinka (glejte poglavje 4.5): - karbamazepin, fenobarbital, fenitoin
6 cells/L),
6 celic/l).
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 mcg/mL.
In vitro je vezava tenofovirja na humane plazemske beljakovine manjša od 0,7% in je neodvisna od koncentracije v razponu od 0,01-25 µg/ml.
Symtuza should not be initiated in patients with eGFRCG < 30 mL/min, as there are no data available regarding the use of Symtuza in this population (see sections 5.1 and 5.2).
Zdravljenja z zdravilom Symtuza se ne sme uvesti bolnikom z eGFRCG < 30 ml/min, saj za to skupino bolnikov ni na voljo podatkov o uporabi zdravila Symtuza (glejte poglavji 5.1 in 5.2).
For emtricitabine, the Cmax was 1.26-fold higher in a fasted condition, while the AUC was comparable in fed and fasted condition.
Cmax emtricitabina je bila 1,26-krat večja po odmerjanju zdravila na tešče, AUC pa je bila primerljiva v pogojih zaužitja zdravila po hrani in na tešče.
Symtuza and sofosbuvir, sofosbuvir/ledipasvir, or daclatasvir can be used concomitantly without dose adjustment
Zdravilo Symtuza in sofosbuvir, sofosbuvir/ledipasvir, ali daklatasvir se sočasno lahko uporablja brez prilagoditve odmerka.
Symtuza may decrease boceprevir plasma concentrations.
Zdravilo Symtuza lahko znižuje koncentracijo boceprevirja v plazmi.
(P-gp, BCRP and/or OATP1B1/3 inhibition)
(zaviranje P-gp , BCRP in/ali OATP1B1/3)
There are no adequate and well controlled trials with darunavir, cobicistat, emtricitabine, or tenofovir alafenamide, alone or in combination, in pregnant women.
Ustreznih in dobro nadzorovanih preskušanj z darunavirjem, kobicistatom, emtricitabinom in alafenamidtenofoviratom v monoterapiji ali v kombinaciji pri nosečnicah niso izvedli.
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Po sočasnem odmerjanju z efavirenzom, testnim zmernim induktorjem CYP3A, se izpostavljenost alafenamidtenofoviratu ni bistveno sprememnila.
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.
V kliničnem preskušanju zdravil darunavirj/ritonavirj (n = 3.063), so o hepatitisu poročali pri 0,5% bolnikov, ki so prejemali kombinirano protiretrovirusno zdravljene s kombinacijo darunavirja/ritonavirja.
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 preiskovancev so izključili iz študije zaradi neustrezne učinkovitosti zdravila po presoji raziskovalca (zdravnikova odločitev).Med njimi so imeli trije preiskovanci med zdravljenjem zadnje izmerjeno virusno breme HIV-1 RNK <50 kopij/ml.
How to take Symtuza
Kako jemati zdravilo Symtuza
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (eGFRCG > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
Klinično pomembnih razlik v farmakokinetičnih lastnostih alafenamidtenofovirata ali tenofovirja med zdravimi osebami in bolniki s hudo okvaro ledvic (eGFRCG > 15 in < 30 ml/min) v študijah z alafenamidtenofoviratom niso opazili.