FrancophonIA/ELRC3.0 huggingface dataset:
English: If vomiting occurs within 1 hour of taking Truvada, another tablet should be taken.
Slovenian: Če v roku 1 ure od jemanja zdravila Truvada pride do bruhanja, je potrebno vzeti drugo tableto.
English: The potential renal and bone effects with long-term use of Truvada for pre-exposure prophylaxis in adolescents are unknown (see section 4.4).
Slovenian: Možnost učinkov na ledvice in kosti pri dolgoročni uporabi zdravila Truvada za zaščito pred izpostavitvijo pri mladostnikih ni znana (glejte poglavje 4.4).
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL.
Slovenian: V 48. tednu je 83 % bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 92 % bolnikov v skupini, zdravljeni s stavudinom ali zidovudinom, imelo koncentracije HIV-1 RNA < 400 kopij/ml.
English: Key Couple Characteristics, N (%) or Median (Q1, Q3) Married to study partner
Slovenian: Ključne lastnosti parov, N (%) ali mediana (Q1, Q3) Zakonska zveza s partnerjem v študiji Število let življenja s partnerjem v študiji Število let zavedanja o neskladnosti
English: Taking Truvada with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Slovenian: Jemanje zdravila Truvada z drugimi zdravili, ki vsebujejo didanozin (za zdravljenje okužbe z virusom HIV): jemanje zdravila Truvada z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša nivoje didanozina v krvi in zmanjša število celic CD4.
English: Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Truvada je indicirano za zaščito pred izpostavitvijo, ob hkratnem upoštevanju varnega spolnega vedenja za zmanjšanje tveganja za spolno pridobljeno okužbo z virusom HIV-1 pri odraslih in mladostnikih z visokim tveganjem (glejte poglavja 4.2, 4.4 in 5.1).
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Slovenian: Na voljo so naslednje velikosti pakiranj: škatle z 1 plastenko s 30 filmsko obloženimi tabletami in z 90 (3 plastenke s 30) filmsko obloženimi tabletami.
English: • That use of Truvada should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Slovenian: • da se je treba uporabi zdravila Truvada izogniti, če bolnik sočasno jemlje ali je predhodno jemal nefrotoksična zdravila.
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Slovenian: • izobraževalno gradivo PrEP za predpisujoče zdravnike z naslovom »Pomembne varnostne informacije za predpisujoče zdravnike glede zdravila Truvada pri indikaciji zaščite pred izpostavitvijo (PrEP)«;
English: Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Na osnovi minimalne jetrne presnove in izločanja emtricitabina preko ledvic je malo verjetno, da bi bila pri bolnikih z jetrno okvaro potrebna prilagoditev odmerka zdravila Truvada (glejte poglavji 4.2 in 5.2).
English: Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Slovenian: Uporabi zdravila Truvada se je treba izogniti pri predhodno zdravljenih bolnikih, okuženih s HIV-1, ki so nosilci mutacije K65R (glejte poglavje 5.1).
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)2
Slovenian: vezikulobulozni izpuščaj, pustulozni izpuščaj, makulopapulozni izpuščaj, izpuščaj, pruritus, urtikarija, sprememba obarvanosti kože (povečana pigmentacija)2
English: While taking Truvada to treat HIV or to reduce the risk of getting HIV:
Slovenian: Če zdravilo Truvada jemljete za zdravljenje okužbe s HIV ali za zmanjšanje tveganja za okužbo s HIV:
English: Individuals should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3 months) using a combined antigen/antibody test while taking Truvada for pre-exposure prophylaxis.
Slovenian: Za zaščito pred izpostavitvijo je treba med jemanjem zdravila Truvada pri posameznikih redno (npr. najmanj vsake 3 mesece) ponovno potrditi, da so HIV negativni, z uporabo kombiniranega testa na antigen/protitelesa.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Pregelatinised starch (gluten free)
Slovenian: Jedro tablete: premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat (E572) mikrokristalna celuloza (E460) predgelirani škrob (brez glutena)
English: Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Truvada je indicirano za zdravljenje mladostnikov, okuženih s HIV-1, z odpornostjo ali toksičnostmi na NRTI, zaradi katere uporaba zdravil prve izbire ni mogoča (glejte poglavja 4.2, 4.4 in 5.1).
English: Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”
Slovenian: Interakcije med zdravilom Truvada ali njegovo(-imi) posamično(-imi) učinkovino(-ami) in drugimi zdravili so navedene v preglednici 2 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓”, brez spremembe z “↔”, dvakrat na dan z “dvakrat dnevno” in enkrat na dan pa z “enkrat dnevno”).
English: Do not take Truvada if you are already taking other medicines that contain the components of Truvada (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Slovenian: Zdravila Truvada ne jemljite, če že jemljete druga zdravila, ki vsebujejo učinkovine zdravila Truvada (emtricitabin in dizoproksiltenofovirat), ali druga protivirusna zdravila, ki vsebujejo tenofoviralafenamid, lamivudin ali dipivoksiladefovirat.
English: Following oral administration of Truvada to healthy subjects, emtricitabine and tenofovir disoproxil are rapidly absorbed and tenofovir disoproxil is converted to tenofovir.
Slovenian: Pri zdravih osebah se po peroralnem vnosu zdravila Truvada emtricitabin in dizoproksiltenofovirat hitro absorbirata in dizoproksiltenofovirat se pretvori v tenofovir.
English: In HIV-1 infected children (aged 2 to 15 years), the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Slovenian: Pri otrocih, okuženih s HIV-1 (starih od 2 do 15 let), so opazili manjše Z-vrednosti MKG pri osebah, ki so prešle na zdravljenje z dizoproksiltenofoviratom, kot pri osebah, ki so ostale na režimu zdravljenja, ki je vključeval stavudine ali zidovudine (glejte poglavji 4.4 in 5.1).
English: Only Case or Cohort samples from subjects randomised to either tenofovir disoproxil 245 mg or Truvada were evaluated for detectable plasma tenofovir levels.
Slovenian: Samo vzorci študijske skupine ali podskupine od oseb, ki so bile randomizirano izbrane za prejemanje dizoproksiltenofovirata 245 mg ali zdravila Truvada, so bili ocenjeni glede zaznane koncentracije tenofovirja v plazmi.
English: Truvada contains lactose
Slovenian: Zdravilo Truvada vsebuje laktozo
English: Truvada 200 mg/245 mg film-coated tablets
Slovenian: IME ZDRAVILA Truvada 200 mg/245 mg filmsko obložene tablete
English: Do not stop taking Truvada • If you take Truvada for treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Slovenian: • Če zdravilo Truvada jemljete za zdravljenje okužbe s HIV, lahko prenehanje zdravljenja zmanjša učinkovitost zdravljenja okužbe s HIV, ki vam ga je predpisal zdravnik.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Slovenian: Povprečni spremembi v 48. tednu (konec randomizirane faze) sta bili 0,032 oz. 0,087 za Z-vrednost MGK ledvene hrbtenice in -0,184 oz. -0,027 za Z-vrednost MGK za celo telo za skupino z dizoproksiltenofoviratom in skupino s stavudinom ali zidovudinom.
English: HIV-1 RNA < 50 copies/mL (TLOVR) p-value % difference (95%CI)
Slovenian: HIV-1 RNA < 50 kopij/ml (TLOVR) Vrednost p
English: There are no data on the long-term renal and bone effects of Truvada when used for pre-exposure prophylaxis in uninfected adolescents (see section 5.1).
Slovenian: Podatkov o dolgoročnih učinkih zdravila Truvada na ledvice in kosti ob zaščiti pred izpostavitvijo pri neokuženih mladostnikih ni (glejte poglavje 5.1).
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL at week 48.
Slovenian: Po izključitvi manjkajočih podatkov je imelo v 48. tednu 91 % bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 94 % bolnikov v skupini, zdravljeni s stavudinom ali zidovudinom, koncentracije HIV-1 RNA < 400 kopij/ml.
English: a Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Slovenian: HIV-pozitivne osebe HIV-negativne kontrolne osebe a Relativno zmanjšanje tveganja, izračunano na podlagi dogodka serokonverzije (po izhodišču) od dvojno slepega obdobja zdravljenja do 8-tedenskega obdobja spremljanja.
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Slovenian: Pri osebah brez jetrne okvare je bila srednja (% koeficienta variacije) vrednost Cmax 223 (34,8%) ng/ml in AUC0-∞ 2.050 (50,8%) ng•h/ml tenofovirja, v primerjavi z 289 (46,0%) ng/ml in 2.310 (43,5%) ng•h/ml tenofovirja pri osebah z zmerno jetrno okvaro ter 305 (24,8%) ng/ml in 2.740 (44,0%) ng•h/ml pri osebah s hudo jetrno okvaro.
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg emtricitabina in 245 mg dizoproksiltenofovirata (kar je ekvivalentno 300 mg dizoproksiltenofovirijevega fumarata ali 136 mg tenofovirja).
English: Truvada, or at any time while taking Truvada.
Slovenian: Truvada ali kadar koli med jemanjem zdravila Truvada obvestite zdravnika.
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Slovenian: n/i = ni izračuna 1 Podatki na podlagi sočasnega odmerjanja ledipasvirja/sofosbuvirja.
English: AUC: ↔ Cmax: ↑ 38% (↑ 14 to ↑ 67)
Slovenian: AUC: ↔ Cmax: ↑ 38 % (↑ 14 do ↑ 67)
English: URAI with HIV+ (or unknown status) Partner Previous 6 Mos, N (%) Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%)
Slovenian: Partnerji z znano okužbo s HIV+ v zadnjih 6 mesecih, N (%) Seroreakcija sifilisa, N (%)
English: Recommendation concerning co-administration with Truvada (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Truvada (emtricitabin 200 mg, dizoproksiltenofovirat 245 mg)
English: Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Slovenian: Zdravljenje okužbe z virusom HIV pri odraslih in mladostnikih, starih 12 let in več, s telesno maso vsaj 35 kg: ena tableta, enkrat dnevno.
English: Seroconversions / Na Incidence per 100 person-years (95% CI)
Slovenian: Serokonverzije/Na Incidenca na 100 človek-let (95-odstotni IZ) Relativno zmanjšanje tveganja (95-odstotni IZ)
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Truvada therapy
Slovenian: • da je pred začetkom zdravljenja z zdravilom Truvada pri pediatričnih bolnikih treba oceniti začetne vrednosti delovanja ledvic;
English: Excipient with known effect
Slovenian: Zaznana učinkovina
English: • That Truvada is not recommended for use in paediatric patients with renal impairment
Slovenian: • da se zdravila Truvada pri pediatričnih bolnikih z ledvično okvaro ne priporoča;
English: Each Truvada film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Slovenian: Ena filmsko obložena tableta zdravila Truvada vsebuje 200 mg emtricitabina in 245 mg dizoproksiltenofovirata (kar je ekvivalentno 300 mg dizoproksiltenofovirijevega fumarata ali 136 mg tenofovirja).
English: No dose adjustment of norgestimate/ethinyl oestradiol is required.
Slovenian: norgestimata/etinilestradiola ni potrebna.
English: Individuals with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving Truvada (see sections 4.2, 4.4 and 5.2).
Slovenian: Ker lahko dizoproksiltenofovirat povzroči ledvično toksičnost, se priporoča skrbno nadziranje ledvične funkcije pri vseh odraslih z ledvično okvaro, ki prejemajo zdravilo Truvada (glejte poglavja 4.2, 4.4 in 5.2).
English: AUC: ↔ Cmax: ↓ 19% (↓ 40 to ↑ 10)
Slovenian: AUC: ↔ Cmax: ↓ 19 % (↓ 40 do ↑ 10)
English: • Provides information on the possible side effects
Slovenian: • nudi informacije o morebitnih neželenih učinkih zdravila Truvada;
English: The recommended dose of Truvada to reduce the risk of getting HIV is:
Slovenian: Priporočeni odmerek zdravila Truvada za zmanjšanje tveganja za okužbo s HIV je:
English: Didanosine: The co-administration of Truvada and didanosine is not recommended (see section 4.4 and Table 2).
Slovenian: Didanozin: Sočasna uporaba zdravila Truvada in didanozina ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
English: NARCOTIC ANALGESICS Methadone/Tenofovir disoproxil
Slovenian: NARKOTIČNI ANALGETIKI metadon/dizoproksiltenofovirat metadon:
English: Co-administration of tenofovir disoproxil and didanosine Co-administration is not recommended because it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina Sočasna uporaba ni priporočena, ker povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60 %, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
English: The use of Truvada is not recommended in individuals under the age of 18 years with renal impairment (see sections 4.2 and 4.4).
Slovenian: Uporabe zdravila Truvada se ne priporoča pri posameznikih, starih manj kot 18 let, z ledvično okvaro (glejte poglavji 4.2 in 4.4).
English: Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Slovenian: Zdravila Truvada naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil (glejte poglavje 4.5).
English: Only samples from subjects randomized to Truvada were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Slovenian: Samo vzorci oseb, ki so randomizirano prejemale zdravilo Truvada, so bili ocenjeni glede zaznanih koncentracij dizoproksiltenofovirata-DP v plazmi ali znotraj celic.
English: Lopinavir/Ritonavir/Emtricitabine Interaction not studied.
Slovenian: lopinavir/ritonavir/emtricitabin Interakcij niso preučevali.
English: Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Slovenian: Zdravila Truvada se ne sme sočasno uporabljati z drugimi zdravili, ki vsebujejo emtricitabin, dizoproksiltenofovirat, tenofoviralafenamid ali druge analoge citidina, kot je lamivudin (glejte poglavje 4.4).
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Slovenian: Povprečni spremembi v 48. tednu (konec dvojno slepe faze) sta bili -0,215 oz.0,165 za Z-vrednost MGK ledvene hrbtenice in -0,254 oz. -0,179 za Z-vrednost MGK za celo telo za skupino z dizoproksiltenofoviratom in skupino s placebom.
English: Lamivudine and Truvada should not be administered concomitantly (see section 4.4).
Slovenian: Lamivudin in zdravilo Truvada se ne sme uporabljati sočasno (glejte poglavje 4.4).
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Truvada use.
Slovenian: Ob odkritju nenormalnega delovanja ledvic ali sumu nanj se je treba posvetovati z nefrologom in razmisliti o prekinitvi uporabe zdravila Truvada.
English: Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).
Slovenian: Zdravilo Truvada se ne sme dajati skupaj z drugimi zdravili, ki vsebujejo emtricitabin, dizoproksiltenofovirat, tenofoviralafenamid ali druge analoge citidina, kot je lamivudin (glejte poglavje 4.5).
English: Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4, Possible side effects).
Slovenian: Zaradi okvare celic ledvičnih tubulov se lahko pojavijo tudi težave s kostmi (včasih pride do zlomov) (glejte poglavje 4.
English: HIV-1 infection: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Slovenian: Okužba s HIV-1: Najpogostejša neželena učinka, o katerih so poročali iz odprte, randomizirane klinične študije pri odraslih (GS-01-934, glejte poglavje 5.1), in ki sta bila verjetno oziroma morda povezana z emtricitabinom in/ali dizoproksiltenofoviratom, sta bila navzea (12 %) in driska (7 %).
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Slovenian: Pri bolnikih, ki so dobivali dizoproksiltenofovirat ali placebo, je bila ob izhodišču povprečna Zvrednost MGK ledvene hrbtenice -1,004 oz. -0,809, in povprečna Z-vrednost MGK za celo telo0,866 oz. -0,584.
English: Emtricitabine+ tenofovir disoproxil+efavirenz*
Slovenian: Emtricitabin+ dizoproksiltenofovirat +efavirenz*
English: Renal safety with Truvada has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 mL/min).
Slovenian: Varnost zdravila Truvada za ledvice pri bolnikih z ledvično okvaro (očistek kreatinina < 80 ml/min), okuženih s HIV-1, so preučevali v zelo omejenem obsegu.
English: Norgestimate:
Slovenian: norgestimat:
English: HIV-1 infected patients receiving Truvada 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.
Slovenian: Pri bolnikih s HIV-1, ki se zdravijo z zdravilom Truvada ali s katero koli drugo obliko protiretrovirusne terapije, lahko še vedno pride do oportunistične okužbe in drugih zapletov okužbe z virusom HIV.
English: Before taking Truvada to reduce the risk of getting HIV:
Slovenian: Pred jemanjem zdravila Truvada, da se zmanjša tveganje za okužbo s HIV:
English: • HIV pediatric renal educational brochure
Slovenian: • izobraževalno gradivo glede ledvic pri HIV za pediatrične bolnike;
English: IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/Emtricitabine
Slovenian: takrolimus/ dizoproksiltenofovirat/ emtricitabin takrolimus:
English: At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/mL with the once and twice daily regimens of lopinavir/ritonavir, respectively.
Slovenian: V 48. tednu je 70% bolnikov v režimu zdravljenja z lopinavirjem/ritonavirjem enkrat na dan in 64% bolnikov v režimu zdravljenja z lopinavirjem/ritonavirjem dvakrat na dan izkazalo HIV-1 RNA < 50 kopij/ml.
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in subjects with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Slovenian: Pri osebah z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti tenofovirju 2.185 (12%) ng•h/ml se je le-ta pri osebah z blago ledvično okvaro zvišala na 3.064 (30%) ng•h/ml, pri osebah z zmerno ledvično okvaro na 6.009 (42%) ng•h/ml in na 15.985 (45%) ng•h/ml pri osebah s hudo ledvično okvaro.
English: As Truvada contains emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Truvada.
Slovenian: Zdravilo Truvada vsebuje emtricitabin in dizoproksiltenofovirat, zato se pri uporabi zdravila Truvada lahko pojavijo katerekoli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
English: The mean (%CV) emtricitabine drug exposure increased from 12 (25%) µg•h/mL in subjects with normal renal function, to 20 (6%) µg•h/mL, 25 (23%) µg•h/mL and 34 (6%) µg•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Slovenian: Pri osebah z normalno ledvično funkcijo s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti emtricitabinu 12 (25%) µg•h/ml se je le-ta pri bolnikih z blago ledvično okvaro zvišala na 20 (6%) µg•h/ml, pri osebah z zmerno ledvično okvaro na 25 (23%) µg•h/ml in na 34 (6%) µg•h/ml pri bolnikih s hudo ledvično okvaro.
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Truvada, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Slovenian: Če je potrjena vrednost serumskega fosfata < 3,0 mg/dl (0,96 mmol/l) pri katerem koli pediatričnem bolniku, ki dobiva zdravilo Truvada, je treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: The pharmacokinetics of Truvada have not been studied in subjects with hepatic impairment.
Slovenian: Farmakokinetike zdravila Truvada niso proučevali pri osebah z jetrno okvaro.
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Slovenian: AUC: ↓ 25% (↓ 42 do ↓ 3) Cmax: ↓ 28% (↓ 50 do ↑ 5) Cmin: ↓ 26% (↓ 46 do ↑ 10)