natgillin/translations-raw huggingface dataset:
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Kombinirano antiretrovirusno zdravljenje lahko spremljajo presnovne anomalije kot na primer hipertrigliceridemija, hiperholesterolemija, inzulinska rezistenca, hiperglikemija in hiperlaktatemija (glejte poglavje 4. 4).
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal
Kombinirano antiretrovirusno zdravljenje lahko spremlja pri bolnikih z okužbo z virusom HIV prerazporeditev telesne maščobe (lipodistrofija), vključno z zmanjšanjem periferne in obrazne podkožne maščobe, povečanjem notranje trebušne in visceralne maščobe, hipertrofijo dojk in kopičenjem maščevja na zadnji strani vratu (buffalo hump) (glejte poglavje 4. 4).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (see section 4.4).
Pri s HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja (CART, combination antiretroviral therapy) nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične okužbe (glejte poglavje 4. 4).
Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
Uporabo do maksimalno 1. 200 mg emtricitabina spremljajo neželeni učinki, navedeni zgoraj (glejte poglavje 4. 8).
Up to 30% of the emtricitabine dose can be removed by haemodialysis.
Do 30% odmerka emtricitabina se lahko odstrani s hemodializo.
Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code:
Nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC:
Mechanism of action:
Mehanizem učinkovanja:
Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus (HBV).
Emtricitabin je sintetični nukleozidni analog citidina z učinkovanjem, ki je specifično humanemu virusu zmanjšane imunosti (HIV- 1 in HIV- 2) in virusu hepatitisa B (HBV).
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
Celični encimi fosforilirajo emtricitabin v emtricitabin 5 '- trifosfat, ki kompetitivno inhibira HIV- 1 reverzno transkriptazo, kar rezultira v prekinitvi verige DNA.
Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Emtricitabin je šibek zaviralec sesalske DNA- polimeraze α, β in ε ter mitohondrijske DNA- polimeraze γ.
Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Emtricitabin ni izkazal citotoksičnosti za periferne mononuklearne krvne celice (PBMC, peripheral blood mononuclear cells), etablirane limfocite, monocitne- makrofagne celične linije ali matične celice kostnega mozga pri in vitro pogojih.
Antiviral activity in vitro:
Antivirusno učinkovanje in vitro:
The 50% inhibitory concentration (IC50) value for emtricitabine against laboratory and clinical isolates of HIV-1 was in the range of 0.0013 to 0.5 µmol/ l.
50% inhibitorna koncentracija (IC50) vrednost emtricitabina proti laboratorijskim in kliničnim izolatom virusa HIV- 1 je bila v razponu od 0, 0013 do 0, 5 µmol/ l.
In combination studies of emtricitabine with protease inhibitors, nucleoside, nucleotide and non-nucleoside analogue inhibitors of HIV reverse transcriptase, additive to synergistic effects were observed.
8 nukleozidnimi analogi zaviralcev HIV reverzne transkriptaze so opazili aditivne ali celo sinergistične učinke.
When tested for activity against laboratory strains of HBV, the 50% inhibitory concentration (IC50) value for emtricitabine was in the range of 0.01 to 0.04 µmol/ l.
Pri testih aktivnosti proti laboratorijskim sevom HBV je bila 50% inhibitorna koncentracija (IC50) za emtricitabin v razponu od 0, 01 do 0, 04 µmol/ l.
Resistance:
Rezistenca:
HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase.
Rezistenca virusa HIV- 1 na emtricitabin se razvije kot posledica sprememb v kodonu 184 HIV reverzne transkriptaze, ki povzroči spremembo metionina v valin (opažen je bil tudi izoleucinski intermediat).
This HIV-1 mutation was observed in vitro and in HIV-1 infected patients.
Ta mutacija virusa HIV- 1 je bila opažena in vitro in pri bolnikih, okuženih z virusom HIV- 1.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir,
Virusi odporni na emtricitabin, so bili navzkrižno odporni na lamivudin, a so ohranili občutljivost za druge nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors) (zidovudin, stavudin, tenofovir, abacavir, didanozin in zalcitabin), na vse ne- nukleozidne zaviralce reverzne transkriptaze (NNRTI, non- nucleoside reverse transcriptase inhibitors) in vse zaviralce proteaz (PI, protease inhibitors).
Viruses resistant to zidovudine, zalcitabine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50=0.002 µmol/ l to 0.08 µmol/ l).
Virusi, odporni na zidovudin, zalcitabin, didanozin in NNRTI- je so obdržali svojo občutljivost za emtricitabin (IC50= od 0, 002 µmol/ l do 0, 08 µmol/ l).
Emtricitabine in combination with other antiretroviral agents, including nucleoside analogues, non-nucleoside analogues and protease inhibitors, has been shown to be effective in the treatment of HIV infection in treatment-naïve patients and treatment-experienced patients with stable virological control.
Emtricitabin, v kombinaciji z drugimi antiretrovirusnimi učinkovinami, vključno z analogi nukleozidov in učinkovinami, ki niso analogi nukleozidov ter zaviralci proteaz, se je izkazal za učinkovito zdravilo pri zdravljenju okužbe z virusom HIV pri bolnikih, ki se zdravijo prvič in pri bolnikih, ki se zdravijo že dalj časa in imajo stabilno stanje virusa v telesu.
In antiretroviral treatment-naïve adults, emtricitabine was significantly superior to stavudine when both medicinal products were taken in combination with didanosine and efavirenz through 48 weeks of treatment.
Pri odraslih, ki se z antiretrovirusnim zdravilom zdravijo prvič, je bil emtricitabin opazno močnejši od stavudina, ko sta bili obe zdravili uporabljeni v kombinaciji z didanozinom in efavirenzom v času 48- tedenskega zdravljenja.
Phenotypic analysis showed no significant changes in emtricitabine susceptibility unless the M184V/ I mutation had developed.
Fenotipska analiza ni pokazala bistvenih sprememb v občutljivosti za emtricitabin, razen če se ni razvila mutacija M184V/ I.
In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a protease inhibitor (PI) or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/ ml) through 48 weeks (77% emtricitabine, 82% lamivudine).
Pri virološko stabilnih odraslih, ki se zdravijo že dalj časa, se emtricitabin, v kombinaciji z NRTI (ali stavudinom ali zidovudinom) in zaviralcem proteaz (PI) ali NNRTI, ni obnesel slabše od lamivudina glede na delež odzivov (< 400 virionov/ ml) v obdobju 48 tednov (77% emtricitabin, 82% lamivudin).
Additionally, in a second study, treatment-experienced adults on a stable PI based highly active antiretroviral therapy (HAART) regimen were randomised to a once daily regimen containing emtricitabine or to continue with their PI-HAART regimen.
V drugi študiji se je pri odraslih, ki se zdravijo dalj časa s PI osnovanim visoko aktivnim stabilnim antiretrovirusnim režimom zdravljenja (HAART, highly active antiretroviral therapy), v nadaljevanju naključno porazdeljeno uporabilo ali kombinirano antiretrovirusno zdravljenje z emtricitabinom ali pa so nadaljevali s PI- HAART režimom.
At 48 weeks of treatment the emtricitabine-containing regimen demonstrated an equivalent proportion of patients with HIV RNA < 400 copies/ ml (94% emtricitabine versus 92%) and a greater proportion of patients with HIV RNA < 50 copies/ ml (95% emtricitabine versus 87%) compared with the patients continuing with their PI-HAART regimen.
V času 48- tedenskega režima zdravljenja, ki je vsebovalo emtricitabin, se je izkazal ekvivalentni delež bolnikov s HIV RNA < 400 virionov/ ml (94% z emtricitabinom proti 92%) in večji delež bolnikov s HIV RNA < 50 virionov/ ml (95% emtricitabina proti 87%) v primerjavi z bolniki, ki so nadaljevali s svojim PI- HAART režimom.
In infants and children older than 4 months, the majority of patients achieved or maintained complete suppression of plasma HIV-1 RNA through 48 weeks (89% achieved ≤ 400 copies/ ml and 77% achieved ≤ 50 copies/ ml).
Pri dojenčkih in otrocih starejših od 4 mesecev je večina v 48. tednih dosegla ali ohranila popolno supresijo plazemske HIV- 1 RNA (89% je doseglo ≤ 400 virionov/ ml in 77% je doseglo ≤ 50 virionov/ ml).
Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Po peroralni uporabi emtricitabina se le- ta hitro in znatno absorbira in doseže najvišjo koncentracijo v plazmi v 1- 2 urah.
In 20 HIV infected subjects receiving 200 mg emtricitabine daily as hard capsules, steady-state plasma emtricitabine peak concentrations (Cmax), trough concentrations (Cmin) and area under the plasma concentration time curve over a 24-hour dosing interval (AUC) were 1.8±0.7 µg/ ml, 0.09±0.07 µg/ ml and 10.0±3.1 µg·h/ ml, respectively.
Pri 20 bolnikih z okužbo z virusom HIV, ki so prejemali 200 mg emtricitabina dnevno v obliki trdih kapsul, so bile koncentracije dinamičnega ravnovesja plazemskega emtricitabina sledeče: najvišja (Cmax) 1, 8 ± 0, 7 µg/ ml, najnižja (Cmin) 0, 09 ± 0, 07 µg/ ml in površina pod časovno krivuljo plazemske koncentracije v 24- urnem dozirnem intervalu (AUC), 10, 0 ± 3, 1 µg· h/ ml.
Steady-state trough plasma concentrations reached levels approximately 4-fold above the in vitro IC90 values for anti-HIV activity.
Doseženo najnižje stanje dinamičnega ravnovesja plazemskih koncentracij (steady- state trough plasma concentrations) je bilo približno 4- krat nad in vitro IC90 vrednostmi za anti- HIV aktivnost.
The absolute bioavailability of emtricitabine from Emtriva 200 mg hard capsules was estimated to be 93% and the absolute bioavailability from Emtriva 10 mg/ ml oral solution was estimated to be 75%.
9 Ocenjena absolutna biološka uporabnost emtricitabina, uporabljenega v obliki Emtriva 200 mg trde kapsule, je 93% in ocenjena absolutna vrednost biološke uporabnosti emtricitabina, uporabljenega v obliki Emtriva 10 mg/ ml peroralne raztopine, je 75%.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/ ml oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard capsules.
V pilotski študiji pri otrocih in bioekvivalentni študiji pri odraslih je biološka uporabnost Emtriva 10 mg/ ml peroralne raztopine predstavljala približno 80% biološke uporabnosti Emtriva 200 mg trdih kapsul.
Administration of Emtriva 200 mg hard capsules with a high-fat meal or administration of Emtriva 10 mg/ ml oral solution with a low-fat or high-fat meal did not affect systemic exposure (AUC0-∞) of emtricitabine; therefore Emtriva 200 mg hard capsules and Emtriva 10 mg/ ml oral solution may be administered with or without food.
Torej se lahko Emtriva 200 mg trda kapsula in Emtriva 10 mg/ ml peroralna raztopina vzameta z ali brez hrane.
9 Distribution:
Porazdelitev:
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/ ml.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot 4% in je neodvisna od koncentracije v razponu med 0, 02 in 200 µg/ ml.
The mean plasma to blood concentration ratio was approximately 1.0 and the mean semen to plasma concentration ratio was approximately 4.0.
Povprečna vrednost razmerja med plazemsko koncentracijo in koncentracijo v krvi je bila približno 1, 0 in povprečna vrednost rezmerja med koncentracijo v semenski tekočini in koncentracijo v plazmi je bila približno 4, 0.
The apparent volume of distribution after intravenous administration of emtricitabine was 1.4±0.3 l/ kg, indicating that emtricitabine is widely distributed throughout the body to both intracellular and extracellular fluid spaces.
Po intravenozni uporabi emtricitabina je bil opažen volumen porazdelitve 1, 4 ± 0, 3 l/ kg, kar nakazuje, da je emtricitabin v telesu široko distribuiran tako znotraj kot zunaj celičnega prostora.
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Biotransformacija emtricitabina vključuje oksidacijo tiolnega dela molekule, pri čemer nastanejo 3 '- sulfoksid diastereomere (približno 9% odmerka) in konjugacijo z glukuronsko kislino, pri čemer nastane 2' - O- glukuronid (približno 4% odmerka).
Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes:
Emtricitabin ni inhibiral in vitro presnove zdravil s pomočjo kateregakoli od naslednjih humanih CYP450 izoencimov:
Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Emtricitabin tudi ni inhibiral uridin- 5 '- difosfoglukuronil- transferaze, encima, ki je odgovoren za glukuronidacijo.
The systemic clearance of emtricitabine averaged 307 ml/ min (4.03 ml/ min/ kg).
Sistemski očistek emtricitabina je v povprečju 307 ml/ min (4, 03 ml/ min/ kg).
Intracellular pharmacokinetics:
Znotrajcelične farmakokinetične lastnosti:
In a clinical study, the intracellular half-life of emtricitabine-triphosphate in peripheral blood mononuclear cells was 39 hours.
V kliničnih študijah je bila znotrajcelična razpolovna doba emtricitabin- trifosfata v perifernih mononuklearnih krvnih celicah 39 ur.
Adults with renal insufficiency:
Odrasli z ledvično insuficienco:
Subjects were grouped according to baseline creatinine clearance (> 80 ml/ min as normal function; 50-80 ml/ min as mild impairment; 30-49 ml/ min as moderate impairment; < 30 ml/ min as severe impairment; < 15 ml/ min as functionally anephric requiring haemodialysis).
Osebe so bile razdeljene v skupine glede na osnovni očistek kreatinina (> 80 ml/ min kot normalna funkcija; 50- 80 ml/ min kot blaga oslabelost; 30- 49 ml/ min kot zmerna oslabelost; < 30 ml/ min kot resna oslabelost; < 15 ml/ min kot funkcionalna anefričnost, ki zahteva hemodializo).
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8±2.9 µg·h/ ml in subjects with normal renal function to 19.9±1.1, 25.0±5.7 and 34.0±2.1 µg·h/ ml, in patients with mild, moderate and severe renal impairment, respectively.
10 Pri osebah z normalno ledvično funkcijo znaša sistemska izpostavljenost emtricitabinu 11, 8 ± 2, 9 µg· h/ ml (povprečje ± standardni odklon) in naraste do 19, 9 ± 1, 1, 25, 0 ± 5, 7 ter do 34, 0 ± 2, 1 µg· h/ ml pri bolnikih z blago, zmerno in resno oslabelostjo.
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 ml/ min and dialysate flow rate of approximately 600 ml/ min).
Pri bolnikih z ledvičnim obolenjem v zadnji fazi (ESRD, end- stage renal disease) na hemodializi je bilo približno 30% odmerka emtricitabina pridobljenega v dializatu po 3 urah dialize, s katero je bolnik začel v roku 1, 5 ure po uporabi emtricitabina (pretok krvi je 400 ml/ min in pretok dializata je približno 600 ml/ min).
Age, gender and ethnicity:
Starost, spol in etnična pripadnost:
10 The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
Povprečna vrednost AUC pri 77 dojenčkih, otrocih in mladostnikih, ki so dobivali 6 mg/ kg emtricitabina v obliki peroralne raztopine enkrat dnevno ali 200 mg emtricitabina v obliki trdih kapsul enkrat dnevno je bila podobna povprečni vrednosti AUC 10, 0 µg· h/ ml pri 20 odraslih, ki so dobivali 200 mg trde kapsule enkrat dnevno.
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/ kg once daily.
V odprti, neprimerjalni študiji so pridobili farmakokinetične podatke pri 20 novorojencih mater, okuženih z virusom HIV, ki so prejemali dva 4- dnevna režima emtricitabina v obliki peroralne raztopine, od prvega tedna do 3 mesecev starosti pri odmerku 3 mg/ kg enkrat dnevno.
This dose is half of that approved for infants aged 4 months and over (6 mg/ kg).
To je polovica odmerka, odobrenega za dojenčke, stare 4 mesece ali več (6 mg/ kg).
The apparent total body clearance at steady state (CL/ F) increased with age over the 3-month period with a corresponding decrease in AUC.
Opažen skupni telesni očistek pri stanju dinamičnega ravnovesja (CL/ F) se je v tem trimesečnem obdobju s starostjo večal, vrednost AUC pa se je ustrezno manjšala.
Plasma emtricitabine exposure (AUC) in infants up to 3 months of age who received 3 mg/ kg emtricitabine once daily was similar to that observed using 6 mg/ kg daily doses in HIV infected adults and children aged 4 months and over.
Plazemska izpostavljenost emtricitabinu (AUC) pri dojenčkih, starih do 3 mesece, ki so prejemali 3 mg/ kg emtricitabina enkrat dnevno, je bila podobna tisti, ki so jo opazili pri odraslih in otrocih, starih 4 mesece ali več, okuženih z virusom HIV, ki so prejemali dnevne odmerke 6 mg/ kg.
Pharmacokinetic data are not available in the elderly.
Farmakokinetični podatki zdravila pri starostnikih niso na razpolago.
Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
Čeprav je bila povprečna vrednost Cmax in Cmin pri ženskah višja za približno 20% in povprečna vrednost AUC višja za 16% kot pri moških, ta razlika ni klinično pomembna.
No clinically important pharmacokinetic difference due to race has been identified.
Ni bilo identificirane klinično pomembne farmakokinetične razlike glede na raso.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and reproductive/ developmental toxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in reproduktivne/ razvojne toksičnosti ne kažejo posebnega tveganja za človeka.
Emtricitabine did not show any carcinogenic potential in long-term oral carcinogenicity studies in mice and rats.
Emtricitabin ni pokazal kancerogenega potenciala v dolgoročnih peroralnih kancerogenetskih študijah na miših in podganah.
Cellulose, microcrystalline (E460) Crospovidone Magnesium stearate (E572) Povidone (E1201)
Vsebina kapsule: mikrokristalna celuloza (E460) krospovidon magnezijev stearat (E572) povidon (E1201)
Gelatin Indigotine (E132) Titanium dioxide (E171)
11 Lupina kapsule: želatina indigotin (E132) titanov dioksid (E171)
Black iron oxide (E172) Shellac (E904)
Vsebina črnila: črn železov oksid (E172) šelak (E904)
White high-density polyethylene (HDPE) bottle fitted with a child-resistant closure, containing 30 hard capsules.
Bela, čvrsta polietilenska (HDPE) plastenka, zaprta z za otroke varno zaporko, ki vsebuje 30 trdih kapsul.
Blisters made of polychlorotrifluorethylene (PCTFE) / polyethylene (PE) / polyvinylchloride (PVC) / aluminium.
Pretisni omot je narejen iz poliklorotrifluoretilena (PCTFE) / polietilena (PE) / polivinilklorida (PVC) / aluminija.
Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Gilead Sciences International Limited Cambridge CB21 6GT Velika Britanija
24 October 2003 Date of last renewal:
24. oktober 2003 Datum zadnjega podaljšanja dovoljenja za promet:
Emtriva 10 mg/ ml oral solution
Emtriva 10 mg/ ml peroralna raztopina
Each ml of Emtriva oral solution contains 10 mg emtricitabine.
1 ml Emtriva peroralne raztopine vsebuje 10 mg emtricitabina.
Each dose (24 ml) contains 36 mg methyl parahydroxybenzoate (E218), 3.6 mg propyl parahydroxybenzoate (E216), 1.2 mg Sunset Yellow (E110) and has a sodium content of 254 mg.
Vsak odmerek (24 ml) vsebuje 36 mg metilparahidroksibenzoata (E218), 3, 6 mg propilparahidroksibenzoata (E216), 1, 2 mg oranžnega FCF (E110) in 254 mg natrija.
Emtriva 10 mg/ ml oral solution may be taken with or without food.
Emtriva 10 mg/ ml peroralna raztopina se lahko jemlje s hrano ali brez.
A measuring cup is provided (see section 6.5).
Merica je priložena (glejte poglavje 6. 5).
The recommended dose of Emtriva 10 mg/ ml oral solution is 240 mg (24 ml) once daily.
Priporočeni odmerek Emtriva 10 mg/ ml peroralne raztopine je 240 mg (24 ml) enkrat dnevno.
Infants, children and adolescents up to 18 years of age:
Dojenčki, otroci in mladostniki do 18. leta starosti:
The recommended dose of Emtriva 10 mg/ ml oral solution is 6 mg/ kg up to a maximum of 240 mg (24 ml) once daily.
Priporočeni odmerek Emtriva 10 mg/ ml peroralne raztopine je 6 mg/ kg do maksimalno 240 mg (24 ml) enkrat dnevno.
Children who weigh at least 33 kg may either take one 200 mg hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
Otroci, ki tehtajo vsaj 33 kg lahko vzamejo ali eno 200 mg trdo kapsulo dnevno ali emtricitabin v obliki peroralne raztopine do maksimalno 240 mg enkrat dnevno.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age.
14 Ni podatkov glede učinkovitosti emtricitabina pri dojenčkih, mlajših od 4- ih mesecev, podatki glede varnosti emtricitabina pa so zelo omejeni.
Therefore Emtriva is not recommended for use in
Zato se uporaba zdravila Emtriva pri bolnikih, mlajših od 4- ih mesecev ne priporoča.
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 ml) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Zaradi razlike v biološki uporabnosti emtricitabina, uporabljenega v obliki trde kapsule ali v obliki peroralne raztopine, naj bi 240 mg emtricitabina, uporabljenega v obliki peroralne raztopine (24 ml), zagotavljalo podoben plazemski nivo, kot je opazen po uporabi emtricitabina v obliki ene 200 mg trde kapsule (glejte poglavje 5. 2).
The table below provides daily doses of Emtriva 10 mg/ ml oral solution according to the degree of renal insufficiency.
Spodnja tabela prikazuje dnevne odmerke Emtriva 10 mg/ ml peroralne raztopine glede na stopnjo ledvične insuficience.
Patients with renal insufficiency can also be managed by administration of Emtriva 200 mg hard capsules at modified dose intervals.
Bolniki z ledvično insuficienco so lahko zdravljeni tudi z Emtriva 200 mg trdimi kapsulami ob prilagojenih intervalih odmerkov.
30-49
240 mg
15-29
120 mg
< 15
60 mg