FrancophonIA/ELRC3.0 huggingface dataset:
English: Serology HBeAg loss / seroconversiond
Slovenian: Serologija Izguba/serokonverzija HBeAgd n/v n/v
English: No dose adjustment of Vemlidy or norgestimate/ethinyl estradiol is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali norgestimata/etinilestradiola ni potrebna.
English: There are no data on the safety and efficacy of Vemlidy in HBV infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
Slovenian: z dekompenzirano boleznijo jeter, ki imajo oceno > 9 (tj. razred C) po Child Pugh Turcotte (CPT), ni.
English: Do not swallow desiccant.
Slovenian: Ne zaužijte sušilnega sredstva.
English: The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Slovenian: Protivirusno aktivnost tenofoviralafenamida so ovrednotili v baterijskem testu izolatov, ki so vsebovali mutacije nukleozidnih/nukleotidnih zaviralcev reverzne transkriptaze v celicah HepG2.
English: Vemlidy 25 mg film-coated tablets tenofovir alafenamide
Slovenian: IME ZDRAVILA Vemlidy 25 mg filmsko obložene tablete tenofoviralafenamid
English: ANTICONVULSANTS Carbamazepine (300 mg orally, b.i.d.)
Slovenian: ANTIEPILEPTIKI karbamazepin (300 mg peroralno, b.i.d.)
English: ALT Normalised ALT (Central lab)b
Slovenian: Normalizirana ALT (centralni laboratorij)b Normalizirana ALT (AASLD)c
English: If the patient vomits within 1 hour of taking Vemlidy, the patient should take another tablet.
Slovenian: Če bolnik v 1 uri od jemanja zdravila Vemlidy bruha, naj vzame še eno tableto.
English: Vemlidy [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Vemlidy [samo zunanja ovojnina]
English: Table 1: Interactions between Vemlidy and other medicinal products
Slovenian: Preglednica 1: Interakcije med zdravilom Vemlidy in drugimi zdravili Učinkovine po terapevtskih področjih
English: ritonavir or cobicistat boosted darunavir, lopinavir or atazanavir
Slovenian: darunavir, lopinavir ali atazanavir, ojačani z ritonavirjem ali kobicistatom,
English: In the open-label phase of Studies 108 and 110, the mean (±SD) change in serum creatinine from Week 96 to Week 120 was -0.002 (0.10) mg/dL in those who remained on Vemlidy, compared to -0.008 (0.09) mg/dL in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Slovenian: V odprti fazi študij 108 in 110 je bila povprečna (±SD) sprememba serumskega kreatinina od 96. tedna do 120. tedna pri tistih, ki so nadaljevali z zdravljenjem z zdravilom Vemlidy, -0,002 (0,10) mg/dl, v primerjavi z -0,008 (0,09) mg/dl pri tistih,
English: • Joint pain (arthralgia)
Slovenian: • bolečina v sklepih (artralgija)
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential with tenofovir disoproxil (as fumarate) and toxicity to reproduction and development with tenofovir disoproxil (as fumarate) or tenofovir alafenamide.
Slovenian: Običajne študije kancerogenega potenciala z dizoproksiltenofoviratom (v obliki fumarata) in vpliva na sposobnost razmnoževanja in razvoja z dizoproksiltenofoviratom (v obliki fumarata) ali tenofoviralafenamida ne kažejo posebnega tveganja za človeka.
English: ANTIMYCOBACTERIALS Rifampicin
Slovenian: rifampicin rifapentin
English: In the open-label phase, the median change in eGFR from Week 96 to Week 120 was -0.6 mL/min in patients who remained on Vemlidy, compared to +1.8 mL/min in patients who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Slovenian: V odprti fazi je bila mediana sprememba vrednosti eGFR od 96. tedna do 120. tedna pri bolnikih, ki so nadaljevali z zdravljenjem z zdravilom Vemlidy, -0,6 ml/min, v primerjavi s +1,8 ml/min pri bolnikih, ki so v 96. tednu z zdravljenja z dizoproksiltenofovirijevim fumaratom prešli na zdravljenje z zdravilom Vemlidy.
English: b The population used for analysis of ALT normalisation included only patients with ALT above upper limit of normal (ULN) of the central laboratory range at baseline.
Slovenian: b Populacija, uporabljena za analizo normalizacije ALT, je vključevala le bolnike z izhodiščno zgornjo mejo normalne vrednosti (ULN, upper limit of normal) ALT nad razponom centralnega laboratorija.
English: Not applicable.
Slovenian: ni treba prilagajati.
English: Vemlidy contains lactose
Slovenian: Zdravilo Vemlidy vsebuje laktozo
English: Baseline HBV DNA < 8 log10 IU/mL ≥ 8 log10 IU/mL
Slovenian: < 8 log10 i.e./ml ≥ 8 log10 i.e./ml n/v n/v
English: ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.)
Slovenian: (0,180 mg/0,215 mg/0,250 mg peroralno, q.d.)
English: Lactose monohydrate, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b).
Slovenian: Laktoza monohidrat, mikrokristalna celuloza (E460(i)), premreženi natrijev karmelozat (E468),
English: Lopinavir/ritonavir (800 mg/200 mg orally, q.d.)
Slovenian: lopinavir/ritonavir (800 mg/200 mg peroralno, q.d.)
English: 90 (3 bottles of 30) film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 HDPE vsebniki po 30) filmsko obloženih tablet
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects.
Slovenian: Pri mladostnikih in odraslih preiskovancih, okuženih s HIV-1, niso opazili nobenih klinično pomembnih razlik pri farmakokinetiki tenofoviralafenamida ali tenofovirja.
English: 21% were treatment-experienced (previous treatment with oral antivirals, including entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), or other (N = 18)).
Slovenian: 24 % jih je imelo genotip HBV B, 38 % jih je imelo genotip HBV C in 31 % jih je imelo genotip HBV D. 21 % se jih je predhodno zdravilo (predhodno zdravljenje s peroralnimi antivirusnimi zdravili, vključno z entekavirjem (N = 41), lamivudinom (N = 42), dizoproksiltenofovirijevim fumaratom (N = 21) ali drugim (N = 18)).
English: Recommendation concerning co-administration with Vemlidy
Slovenian: Priporočila glede sočasne uporabe z zdravilom Vemlidy nevirapin
English: Rilpivirine (25 mg orally, q.d.)
Slovenian: rilpivirin (25 mg peroralno, q.d.)
English: • Feeling bloated
Slovenian: • občutek napihnjenosti
English: ↑ Tenofovir alafenamide
Slovenian: ↔ velpatasvir ↑ tenofoviralafenamid
English: At baseline, mean plasma HBV DNA was 5.8 log10 IU/mL, mean serum ALT was 94 U/L, and 9% of patients had a history of cirrhosis.
Slovenian: Ob izhodišču je bila povprečna vrednost HBV DNA v plazmi 5,8 log10 i.e./ml, povprečna vrednost serumske ALT je bila 94 e./l in
English: Atazanavir/ritonavir (300 mg/100 mg orally, q.d.)
Slovenian: atazanavir/ritonavir (300 mg/100 mg peroralno, q.d.)
English: The efficacy and safety of Vemlidy in patients with chronic hepatitis B are based on 48- and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-320-0108 (“Study 108”) and GS-US-320-0110 (“Study 110”).
Slovenian: Učinkovitost in varnost zdravila Vemlidy pri bolnikih s kroničnim hepatitisom B temelji na 48 in 96tedenskih podatkih iz dveh randomiziranih, dvojno slepih, z učinkovino nadzorovanih študij,
English: Co-administration of Vemlidy with certain anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g. rifampicin, rifabutin and rifapentine) or St. John's wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended.
Slovenian: Sočasna uporaba zdravila Vemlidy z nekaterimi antikonvulzivnimi zdravili (npr. karbamazepin, okskarbazepin, fenobarbital in fenitoin), učinkovinami za zdravljenje okužb z mikobakterijami (npr. rifampicin, rifabutin in rifapentin) ali šentjanževko ni priporočljiva, saj so induktorji
English: • tenofovir disoproxil fumarate
Slovenian: • dizoproksiltenofovirijev fumarat
English: Oral administration.
Slovenian: Peroralno dajanje.
English: Vemlidy (N = 285)
Slovenian: (N = 285)
English: General disorders and administration site conditions Common
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: 26% were treatment-experienced (previous treatment with oral antivirals, including adefovir (N = 42), entecavir (N = 117), lamivudine (N = 84), telbivudine
Slovenian: 17 % jih je imelo genotip HBV B, 52 % jih je imelo genotip HBV C in 23 % jih je imelo genotip HBV D. 26 % se jih je predhodno zdravilo (predhodno zdravljenje s peroralnimi antivirusnimi zdravili, vključno z adefovirjem (N = 42), entekavirjem (N = 117), lamivudinom (N = 84), telbivudinom (N = 25), dizoproksiltenofovirijevim fumaratom (N = 70) ali drugim (N = 17)).
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Slovenian: Tenofoviralafenamid in vitro pri človeku ni zaviralec uridindifosfat-glukuronoziltransferaze
English: What Vemlidy is and what it is used for What you need to know before you take Vemlidy How to take Vemlidy
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vemlidy Kako jemati zdravilo Vemlidy
English: c Study conducted with emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
Slovenian: c Študija je bila opravljena s tableto s kombinacijo emtricitabina/tenofoviralafenamida v fiksnem odmerku.
English: f Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
Slovenian: f Študija je bila opravljena s tableto s kombinacijo emtricitabina/rilpivirina/tenofoviralafenamida v fiksnem odmerku.
English: If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek in je od časa, ko ga običajno vzame, minilo več kot 18 ur, bolnik ne sme vzeti izpuščenega odmerka in mora z jemanjem nadaljevati kot običajno.
English: The pharmacokinetics of tenofovir alafenamide and tenofovir were evaluated in HIV-1 infected, treatment-naïve adolescents who received tenofovir alafenamide (10 mg) given with elvitegravir,
Slovenian: Farmakokinetika tenofoviralafenamida in tenofovirja je bila ocenjena pri mladostnikih, okuženih s HIV-1, ki niso bili predhodno zdravljeni in so prejemali tenofoviralafenamid (10 mg) skupaj z elvitegravirjem, kobicistatom in emtricitabinom kot kombinirano tableto v fiksnem odmerku (E/C/F/TAF; Genvoya).
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172)
Slovenian: titanov dioksid (E171) makrogol (E1521)
English: ↑ Cmin 1.85 (1.78, 1.92)
Slovenian: ↑ AUC 1,75 (1,69; 1,81) ↑ Cmin 1,85 (1,78; 1,92)
English: Tenofovir alafenamide ↓ Cmax 0.43 (0.36, 0.51) ↓ AUC 0.45 (0.40, 0.51)
Slovenian: ↓ Cmax 0,43 (0,36; 0,51) ↓ AUC 0,45 (0,40; 0,51)
English: ↔ Tenofovir alafenamide ↔ Maraviroc
Slovenian: ↔ tenofoviralafenamid ↔ maravirok
English: How to store Vemlidy
Slovenian: Shranjevanje zdravila Vemlidy
English: Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
Slovenian: Ena filmsko obložena tableta zdravila Vemlidy vsebuje tenofoviralafenamidijev fumarat, kar ustreza 25 mg tenofoviralafenamida.
English: Vemlidy contains lactose monohydrate.
Slovenian: Neprenašanje laktoze Zdravilo Vemlidy vsebuje laktozo monohidrat.
English: Elderly No dose adjustment of Vemlidy is required in patients aged 65 years and older (see section 5.2).
Slovenian: Pri bolnikih, starih 65 let ali več, odmerka zdravila Vemlidy ni treba prilagajati (glejte poglavje 5.2).
English: • Feeling sick (nausea)
Slovenian: • driska • slabost (bruhanje)
English: Antiviral activity
Slovenian: PERORALNI KONTRACEPTIVI
English: No dose adjustment of Vemlidy or sertraline is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali sertralina ni potrebna.
English: The active substance is tenofovir alafenamide.
Slovenian: Učinkovina je tenofoviralafenamid.
English: rifabutin, rifampicin or rifapentine
Slovenian: rifabutin, rifampicin ali rifapentin,
English: Rash, pruritus
Slovenian: Pogosti izpuščaj, pruritus
English: No dose adjustment of Vemlidy or nevirapine is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali nevirapina ni potrebna.
English: Sertraline ↔ Cmax 1.14 (0.94, 1.38) ↔ AUC 0.93 (0.77, 1.13)
Slovenian: ↔ Cmax 1,14 (0,94; 1,38) ↔ AUC 0,93 (0,77; 1,13)
English: HBV DNA ≥ 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
Slovenian: < 7 log10 i.e./ml ≥ 7 log10 i.e./ml n/v n/v
English: Discontinued study drug due to lack of efficacy Discontinued study drug due to AE or death Discontinued study drug due to other reasonsd
Slovenian: Brez predhodnega zdravljenja z nukleozidic Zdravljeni z nukleozidi V oknu 48. tedna ni viroloških podatkov Prekinitev uporabe študijskega zdravila zaradi neučinkovitosti Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrti
English: No dose adjustment of Vemlidy or raltegravir is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali raltegravirja ni potrebna.
English: The safety of Vemlidy is also supported by pooled data from patients in Studies 108 and 110 who remained on blinded treatment from Week 96 through Week 120 and additionally from patients in the open-label phase of Studies 108 and 110 from Week 96 through Week 120 (N = 361 remained on Vemlidy; N = 180 switched from tenofovir disoproxil fumarate to Vemlidy at Week 96).
Slovenian: Varnost zdravila Vemlidy je prav tako podprta z združenimi podatki bolnikov v študijah 108 in 110, ki so nadaljevali s slepim zdravljenjem od 96. tedna do konca 120. tedna, ter dodatno od bolnikov v odprti fazi študij 108 in 110
English: Table 4: Additional efficacy parameters at Week 48a
Slovenian: Preglednica 4: Dodatni parametri učinkovitosti v 48. tednua Študija 108 (HBeAg-negativni)
English: TDF = tenofovir disoproxil fumarate a Missing = failure analysis b Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
Slovenian: b Prilagojeno za izhodiščne plazemske kategorije HBV DNA in stratume statusa peroralnega protivirusnega zdravljenja c Preiskovanci, ki predhodno niso bili zdravljeni, so < 12 tednov prejemali peroralno protivirusno zdravljenje s poljubnim nukleozidom ali nukleotidnim analogom, vključno z dizoproksiltenofovirijevim fumaratom ali tenofoviralafenamidom.
English: System organ class Frequency
Slovenian: Organski sistem
English: No additional adverse reactions to Vemlidy were identified from Week 96 through Week 120 in the double-blind phase and in the subset of subjects receiving open-label Vemlidy treatment (see section 5.1).
Slovenian: V dvojno slepi fazi in v podskupini oseb, ki so se odprto zdravile z zdravilom Vemlidy, od 96. tedna do konca 120. tedna niso ugotovili nobenih dodatnih neželenih učinkov zdravila Vemlidy (glejte poglavje 5.1).
English: Tenofovir ↑ Cmax 1.62 (1.56, 1.68)
Slovenian: ↑ Cmax 1,62 (1,56; 1,68)
English: Changes in measures of bone mineral density In both studies tenofovir alafenamide was associated with smaller mean percentage decreases in bone mineral density (BMD; as measured by hip and lumbar spine dual energy X ray absorptiometry
Slovenian: V obeh študijah je bil tenofoviralafenamid povezan z manjšim povprečnim odstotnim zmanjšanjem mineralne gostote kosti (BMD, bone mineral density; izmerjeno v kolku in hrbtenici z analizo dvoenergijske rentgenske absorpciometrije [DXA]) v primerjavi z dizoproksiltenofovirijevim fumaratom po 96. tednih zdravljenja.
English: Midazolam ↔ Cmax 1.02 (0.92, 1.13) ↔ AUC 1.13 (1.04, 1.23)
Slovenian: ↔ Cmax 1,02 (0,92; 1,13) ↔ AUC 1,13 (1,04; 1,23)
English: Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.
Slovenian: Tenofovir difosfat zavira replikacijo HBV tako,
English: Co-administration of Vemlidy with strong inhibitors of P-gp (e.g. itraconazole and ketoconazole) may increase tenofovir alafenamide plasma concentrations.
Slovenian: Sočasna uporaba zdravila Vemlidy z močnimi zaviralci P-gp (npr. itrakonazolom in ketokonazolom)
English: • Diarrhoea
Slovenian: • glavobol
English: Relative to fasting conditions, the administration of a single dose of Vemlidy with a high fat meal resulted in a 65% increase in tenofovir alafenamide exposure.
Slovenian: Glede na pogoje na tešče je dajanje enega odmerka zdravila Vemlidy z obrokom z visoko vsebnostjo maščob povzročil
English: Adverse reaction Nervous system disorders Very common Headache Common
Slovenian: Najpogostejši poročani neželeni učinki so bili glavobol
English: Stopping treatment with Vemlidy may cause your hepatitis B to get worse.
Slovenian: Prenehanje zdravljenja z zdravilom Vemlidy lahko povzroči poslabšanje vašega hepatitisa B. Pri nekaterih bolnikih z napredovalo boleznijo jeter ali cirozo lahko to ogrozi življenje.
English: There are no data on the safety and efficacy of Vemlidy in patients co-infected with hepatitis C or D virus.
Slovenian: Podatkov o varnosti in učinkovitosti zdravila Vemlidy pri bolnikih, okuženih s HBV,
English: Medicines used in treating hepatitis B infection
Slovenian: UČINKOVINE ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI
English: No dose adjustment of Vemlidy or rilpivirine is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali rilpivirina ni potrebna.
English: Norelgestromin ↔ Cmax 1.17 (1.07, 1.26) ↔ AUC 1.12 (1.07, 1.17) ↔ Cmin 1.16 (1.08, 1.24)
Slovenian: ↔ Cmax 1,17 (1,07; 1,26) ↔ AUC 1,12 (1,07; 1,17) ↔ Cmin 1,16 (1,08; 1,24)
English: Table 3: HBV DNA efficacy parameters at Week 48a
Slovenian: Preglednica 3: Parametri učinkovitosti HBV DNA v 48. tednua Študija 108 (HBeAg-negativni)
English: Based on Phase 3 population pharmacokinetic analysis in subjects with chronic hepatitis B, mean steady state AUC0-24 for tenofovir alafenamide (N = 698) and tenofovir (N = 856) were 0.22 µg•h/mL and 0.32 µg•h/mL, respectively.
Slovenian: (N = 698) 0,22 µg•h/ml, za tenofovir (N = 856) pa 0,32 µg•h/ml.
English: Fertility
Slovenian: Vemlidy
English: No dose adjustment of Vemlidy or ledipasvir/sofosbuvir is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali ledipasvirja/sofosbuvirja ni potrebna.
English: Tenofovir ↓ Cmax 0.70 (0.65, 0.74)
Slovenian: ↓ Cmax 0,70 (0,65; 0,74) ↔ AUC 0,77 (0,74; 0,81)
English: Vemlidy contains the active substance tenofovir alafenamide.
Slovenian: Zdravilo Vemlidy vsebuje učinkovino tenofoviralafenamid.
English: Flares on treatment
Slovenian: Izbruh med zdravljenjem
English: Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999
Slovenian: Tel: + 353 (0) 214 825 999
English: Norgestrel ↔ Cmax 1.10 (1.02, 1.18) ↔ AUC 1.09 (1.01, 1.18) ↔ Cmin 1.11 (1.03, 1.20)
Slovenian: ↔ Cmax 1,10 (1,02; 1,18) ↔ AUC 1,09 (1,01; 1,18) ↔ Cmin 1,11 (1,03; 1,20)
English: e Study conducted with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
Slovenian: e Študija je bila opravljena s tableto s kombinacijo elvitegravirja/kobicistata/emtricitabina/tenofoviralafenamida v fiksnem odmerku.
English: Nevirapine
Slovenian: rilpivirin
English: Tenofovir ↑ Cmax 2.12 (1.86, 2.43)
Slovenian: ↑ Cmax 2,12 (1,86; 2,43) ↑ AUC 2,62 (2,14; 3,20)
English: Darunavir ↔ Cmax 0.99 (0.91, 1.08) ↔ AUC 1.01 (0.96, 1.06) ↔ Cmin 1.13 (0.95, 1.34)
Slovenian: ↔ Cmax 0,99 (0,91; 1,08) ↔ AUC 1,01 (0,96; 1,06) ↔ Cmin 1,13 (0,95; 1,34)
English: • anticonvulsants used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Slovenian: karbamazepin, okskarbazepin, fenobarbital ali fenitoin,
English: Ethinylestradiol ↔ Cmax 1.22 (1.15, 1.29) ↔ AUC 1.11 (1.07, 1.16) ↔ Cmin 1.02 (0.93, 1.12)
Slovenian: ↔ Cmax 1,22 (1,15; 1,29) ↔ AUC 1,11 (1,07; 1,16) ↔ Cmin 1,02 (0,93; 1,12)
English: ↑ Cmin 1.35 (1.21, 1.51)
Slovenian: ↑ AUC 1,52 (1,43; 1,61)
English: No dose adjustment of Vemlidy or sofosbuvir/velpatasvir is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali sofosbuvirja/velpatasvirja/
English: Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Slovenian: Tlf: + 46 (0) 8 5057 1849
English: Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Slovenian: Puh/Tel: + 46 (0) 8 5057 1849
English: • Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys.
Slovenian: • Če imate bolezen ledvic ali testi pokažejo, da imate težave z ledvicami, se posvetujte z zdravnikom ali farmacevtom.
English: Rifapentine
Slovenian: kobicistat
English: (may affect more than 1 in 10 people) • Headache
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: 1,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity associated with the use of tenofovir disoproxil fumarate.
Slovenian: Večje število podatkov o uporabi dizoproksiltenofovirijevega fumarata pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na njegovo malformacijsko ali feto/neonatalno toksičnost.
English: Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus.
Slovenian: zlasti simptome, ki jih povezujete z okužbo s hepatitisom B.
English: Fatigue
Slovenian: ALT
English: Nucleoside-naïveb Nucleoside-experienced ALT
Slovenian: Brez predhodnega zdravljenja z nukleozidib Zdravljeni z nukleozidi
English: Tenofovir alafenamidec (10 mg orally, s.d.)
Slovenian: tenofoviralafenamidc (10 mg peroralno, s.d.)
English: ↑ Cmin 3.21 (2.90, 3.54) Darunavir ↔ Cmax 1.02 (0.96, 1.09)
Slovenian: ↑ Cmax 2,42 (1,98; 2,95) ↑ AUC 2,05 (1,54; 2,72)
English: Tenofovir alafenamide This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Vemlidy 25 mg filmsko obložene tablete tenofoviralafenamid Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: BOTTLE AND CARTON LABELLING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI HDPE VSEBNIKA IN ŠKATLI
English: ↓ Tenofovir alafenamide
Slovenian: ↓ tenofoviralafenamid
English: No dose adjustment of Vemlidy or sofosbuvir is required.
Slovenian: Vemlidy ali sofosbuvirja ni potrebna.
English: Darunavir/cobicistat (800 mg/150 mg orally, q.d.)
Slovenian: atazanavir/kobicistat (300 mg/150 mg peroralno, q.d.)
English: Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Slovenian: Tel: + 353 (0) 1 686 1888
English: Tenofovir alafenamideh (40 mg orally, q.d.)
Slovenian: tenofoviralafenamidh (40 mg peroralno, q.d.)
English: No dose adjustment of Vemlidy or efavirenz is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali efavirenza ni potrebna.
English: Tenofovir alafenamidec (25 mg orally, s.d.)
Slovenian: tenofoviralafenamidc (25 mg peroralno, s.d.)
English: Tenofovir alafenamidec (10 mg orally, q.d.)
Slovenian: tenofoviralafenamidc (10 mg peroralno, q.d.)
English: Sofosbuvir/velpatasvir (400 mg/100 mg orally, q.d.)
Slovenian: sofosbuvir (400 mg peroralno, q.d.)
English: Vemlidy is used to treat chronic (long-term) hepatitis B in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Slovenian: Zdravilo Vemlidy se uporablja za zdravljenje kroničnega (dolgotrajnega) hepatitisa B pri odraslih in mladostnikih, starih 12 let ali več, s telesno maso vsaj 35 kg. Hepatitis B je okužba, ki vpliva na jetra, in jo povzroča virus hepatitisa B. Pri bolnikih s hepatitisom B zdravilo Vemlidy nadzoruje okužbo tako, da prepreči razmnoževanje virusa.
English: Tenofovir ↓ Cmax 0.75 (0.67, 0.86)
Slovenian: ↓ Cmax 0,75 (0,67; 0,86) ↔ AUC 0,80 (0,73; 0,87) ↔ Cmin 0,82 (0,75; 0,89)
English: Tenofovir ↔ Cmax 1.10 (0.96, 1.25)
Slovenian: ↔ Cmax 1,10 (0,96; 1,25) ↑ AUC 1,25 (1,06; 1,47)
English: Tenofovir alafenamidef (25 mg orally, q.d.)
Slovenian: tenofoviralafenamidf (25 mg peroralno, q.d.)
English: No dose adjustment of Vemlidy or maraviroc is required.
Slovenian: Prilagoditev odmerka zdravila Vemlidy ali maraviroka ni potrebna.
English: Tenofovir alafenamidec (25 mg orally, q.d.)
Slovenian: tenofoviralafenamidc (25 mg peroralno, q.d.)
English: Tenofovir alafenamidee (10 mg orally, q.d.)
Slovenian: tenofoviralafenamide (10 mg peroralno, q.d.)