natgillin/translations-raw huggingface dataset:
The safety and efficacy of Odefsey in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Varnost in učinkovitost zdravila Odefsey pri bolnikih s hkratno okužbo s HIV-1 in virusom hepatitisa C (HCV) nista bili dokazani.
The pharmacokinetics of emtricitabine have not been studied in patients with varying degrees of hepatic insufficiency; however emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Farmakokinetičnih lastnosti emtricitabina pri bolnikih z različnimi stopnjami jetrne insuficience niso proučevali, vendar jetrni encimi emtricitabina ne presnavljajo v pomembnem obsegu, zato je vpliv jetrne okvare verjetno omejen.
Interactions between Odefsey or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Interakcije med zdravilom Odefsey ali posameznimi učinkovinami zdravila in sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom „↑“, zmanjšanje z „↓“, brez spremembe z „↔“).
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Rilpivirin in vitro zavira P-glikoprotein (P-gp) (50-odstotna inhibitorna koncentracija [IC50] je 9,2 µM).
Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Med temi 12 izolati HIV-1 so se pojavile mutacije M184V/I (n = 11) in K65R/N (n = 2) v RT ter T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) in N155H (n = 2) v integrazi.
EFV = efavirenz; RPV = rilpivirine a ITT TLOVR = Intention to treat time to loss of virologic response.
EFV = efavirenz; RPV = rilpivirin a ITT TLOVR = čas do izgube virološkega odziva v skupini z namenom zdravljenja.
Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Zdravilu Odefsey se je treba izogniti pri bolnikih z ocenjenim CrCl ≥ 15 ml/min in < 30 ml/min ali < 15 ml/min, ki niso na kronični hemodializi, saj varnosti zdravila Odefsey pri teh populacijah niso dokazali.
somnolence1
somnolenca1
Each bottle contains silica gel desiccant and polyester coil.
Vsak vsebnik vsebuje silikagelsko sušilno sredstvo in poliestrsko vato.
H2-antagonists can only be taken once a day if you take Odefsey.
Antagoniste receptorjev H2 lahko jemljete le enkrat dnevno, če jemljete zdravilo Odefsey.
Interaction not studied with any of the components of Odefsey.
Interakcije niso preučili z nobeno od učinkovin zdravila Odefsey.
The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Farmakokinetične lastnosti rilpivirina pri pediatričnih bolnikih, mlajših od 12 let, se preučuje.
Odefsey contains lactose monohydrate.
Zdravilo Odefsey vsebuje laktozo monohidrat.
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom in imajo hude klinične izvide neznanega vzroka, zlasti nevrološke izvide.
The safety profile in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Varnostni profil pri bolnikih z blago do zmerno ledvično okvaro je bil podoben kot pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 5.1).
The adverse reactions in Table 2 are listed by system organ class and highest frequency observed.
Neželeni učinki v preglednici 2 so našteti po organskih sistemih in pogostnosti.
Following administration of tenofovir alafenamide, plasma [14C] -radioactivity showed a time-dependent profile, with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Po dajanju tenofoviralafenamida je plazemska [14C]-radioaktivnost pokazala časovno odvisni profil, pri tem je bil tenofoviralafenamid najbolj zastopana vrsta radioaktivnosti v prvih nekaj urah in sečna kislina v preostalem obdobju.
• increased fatty acids (triglycerides), bilirubin or lipase in the blood
• zvišanje maščobnih kislin (trigliceridov), bilirubina ali sladkorja lipaze v krvi
Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Izidi zdravljenj v študijah GS-US-366-1216 in GS-US-366-1160 so prikazani v preglednici 5.
As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Odefsey (see section 4.4).
Kot pri vseh drugih protiretrovirusnih zdravilih morajo biti testiranje rezistence in/ali podatki o rezistenci v anamnezi vodilo za uporabo zdravila Odefsey (glejte poglavje 4.4).
If you take more Odefsey than you should
Če ste vzeli večji odmerek zdravila Odefsey, kot bi smeli
No human data on the effect of Odefsey on fertility are available.
Ni podatkov o učinkih zdravila Odefsey na plodnost pri ljudeh.
increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
zvišanje skupnega holesterola (na tešče)1, zvišanje holesterola LDL (na tešče)1
decreased appetite1, increased triglycerides (fasted)1
zmanjšanje apetita1, zvišanje trigliceridov (na tešče)1
Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Zelo pogosti neželeni učinki (vseh stopenj) so bili glavobol, depresija, somnolenca in navzea.
Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Študije na živalih ne kažejo škodljivih učinkov emtricitabina, rilpivirinijevega klorida ali tenofoviralafenamida na plodnost (glej poglavje 5.3)
There is insufficient information on the effects of all the components of Odefsey in newborns/infants, therefore Odefsey should not be used during breast-feeding.
Podatki o učinku vseh učinkovin zdravila Odefsey na dojene novorojence/otroke so nezadostni, zato se zdravilo Odefsey med dojenjem ne sme uporabljati.
Resistance testing and/or historical resistance data should guide the use of Odefsey (see section 5.1).
Testiranje rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Odefsey (glejte poglavje 5.1).
• dexamethasone (oral and parenteral doses), except as a single dose treatment
• deksametazon (peroralni in parenteralni odmerki), razen pri zdravljenju z enkratnim odmerkom
The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Farmakokinetična izpostavljenost rilpivirinu pri bolnikih s sočasno okužbo je bila primerljiva s tisto pri bolnikih brez sočasne okužbe.
Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Rilpivirinijev klorid se pretežno presnavlja in izloča v jetrih.
When your supply of Odefsey starts to run low, get more from your doctor or pharmacist.
Ko se vaše zaloge zdravila Odefsey manjšajo, si ga priskrbite pri svojem zdravniku ali farmacevtu.
The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
Kombinacija emtricitabina, rilpivirina in tenofoviralafenamida ni bila antagonistična in dokazana je bila sinergijska protivirusna aktivnost v celični kulturi.
Tenofovir diphosphate inhibits HIV RT, resulting in DNA chain termination.
Tenofovir difosfat zavira HIV RT, kar povzroči prekinitev verige DNA.
In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were 21%, 29% and 35% lower, respectively, as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were 20%, 31% and 42% lower, respectively, as compared to postpartum.
Pri ženskah, ki so prejemale 25 mg rilpivirina enkrat dnevno med 2. trimesečjem nosečnosti, so bile srednje vrednosti med posameznicami za vrednosti celokupnega rilpivirina Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 21 %, 29 % in 35 %; med 3. trimesečjem nosečnosti pa so bile vrednosti Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 20 %, 31 % in 42 %.
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Farmakokinetičnih lastnosti rilpivirina niso proučevali pri bolnikih z ledvično insuficienco.
Film-coating: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
Filmska obloga: makrogol, polivinilalkohol, smukec, titanov dioksid (E171), črni železov oksid (E172).
There were no clinically significant changes in fasting lipid laboratory tests in patients who switched.
Klinično pomembnih sprememb v laboratorijskih preiskavah lipidov na tešče pri bolnikih, ki so prešli, ni bilo.
Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Ženske v rodni dobi/uporaba kontracepcije pri moških in ženskah Pri uporabi zdravila Odefsey je treba uporabljati učinkovito kontracepcijo.
If Odefsey is stopped for any reason, speak to your doctor before you restart taking Odefsey tablets.
Če zaradi katerega koli razloga prenehate jemati zdravilo Odefsey, se pogovorite s svojim zdravnikom, preden začnete ponovno jemati tablete zdravila Odefsey.
a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102).
a n = 24 mladostnikov (GS-US-292-0106); n = 19 odraslih (GS-US-292-0102).
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Drugi možni neželeni učinki, ki se lahko pojavijo med zdravljenjem okužbe z virusom HIV Pogostnost naslednjih neželenih učinkov je neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Substituciji K65R in K70E povzročita manjšo občutljivost za abakavir, didanozin, lamivudin, emtricitabin in tenofovir, vendar ohranita občutljivost za zidovudin.
• signs or symptoms of inflammation or infection
• znaki ali simptomi vnetja ali okužbe
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
In vitro je vezava tenofovirja na humane plazemske proteine < 0,7 % in je neodvisna od koncentracije v razponu med 0,01-25 µg/ml.
2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
2 Tega neželenega učinka niso opazili v študijah faze III, v katerih so preučevali emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom, ali v študijah 3. faze z zdravilom Odefsey, temveč je bil opredeljen v kliničnih študijah ali izkušnjah v obdobju trženja za emtricitabin pri uporabi z drugimi protiretrovirusnimi zdravili.
It is not known whether emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.
Ni znano, ali so emtricitabin ali tenofoviralafenamid zaviralci drugih encimov UGT.
In patients with severe renal impairment or end-stage renal disease, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Pri bolnikih s hudo ledvično okvaro ali z ESRD so lahko koncentracije v plazmi zvišane zaradi spremenjene absorpcije, porazdelitve in/ali presnove zdravila kot posledica ledvične disfunkcije.
What Odefsey looks like and contents of the pack
Izgled zdravila Odefsey in vsebina pakiranja
nausea1, 3, increased pancreatic amylase1
navzea1,3, zvišanje pankreatične amilaze1
The mean steady-state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Povprečna plazemska koncentracija v stanju dinamičnega ravnovesja 24 ur po odmerjanju, pred naslednjim odmerkom je bila enaka ali večja kot povprečna vrednost IC90 in vitro za aktivnost proti-HIV-1.
The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Mutacije, povezane z rezistenco na NRTI, ki so se razvile pri 3 ali več bolnikih, so bile: K65R, K70E, M184V/I in K219E.
Pooled treatment outcomes at 48 weeks are shown in Table 3.
Združeni izidi zdravljenja v 48. tednu so prikazani v preglednici 3.
Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Bolniki z začetno virusno obremenitvijo > 100,000 HIV-1 RNA kopij/ml, pri katerih se je pojavil virološki neuspeh, so imeli višjo stopnjo rezistence na NNRTI, nastale med zdravljenjem.
b n = 23 adolescents (GS-US-292-0106, population PK analysis).
b n = 23 mladostnikov (GS-US-292-0106, populacijska FK-analiza).
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex US).
b V obeh študijah so bili bolniki stratificirani glede na začetno vrednost HIV-1 RNA (≤ 100.000 kopij/ml, > 100.000 kopij/ml do ≤ 400.000 kopij/ml ali > 400.000 kopij/ml), po številu celic CD4+ (< 50 celic/μl, 50-199 celic/μl ali ≥ 200 celic/μl) in po regiji (ZDA ali zunaj ZDA).
After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Po enkratnem peroralnem odmerku [14C]-rilpivirina se je povprečno 85 % radioaktivnosti izločilo v blatu in 6,1 % v urinu.
Only H2-receptor antagonists that can be dosed once daily should be used.
Uporabljajte samo antagoniste receptorjev H2, ki jih je mogoče odmerjati enkrat dnevno.
While taking Odefsey you may still develop infections or other illnesses associated with HIV infection.
Med jemanjem zdravila Odefsey se lahko pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
It is important not to miss a dose of Odefsey.
Pomembno je, da ne pozabite vzeti odmerka zdravila Odefsey.
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Tenofovir se izloča preko ledvic tako z glomerularno filtracijo kot z aktivno tubularno sekrecijo.
At the start of treatment with E/C/F/TAF, the 72 patients had been HIV suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Na začetku zdravljenja z E/C/F/TAF je imelo 72 bolnikov vsaj 6 mesecev supresijo HIV (HIV-1 RNA < 50 kopij/ml) s supresijo HBV DNA ali brez nje in kompenzirano jetrno funkcijo.
Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food Do not chew, crush or split the tablet.
Mladostniki, stari 12 let in več, s telesno maso vsaj 35 kg: ena tableta na dan s hrano Tablete ne žvečite, drobite in ne delite.
At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults.
V 48. tednu je 92 % (46/50) doseglo HIV-1 RNA < 50 kopij/ml, podobno stopnjam odziva v študijah predhodno nezdravljenih odraslih, okuženih s HIV-1.
If you forget to take Odefsey
Če ste pozabili vzeti zdravilo Odefsey
On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.
Ob dneh hemodialize je treba zdravilo Odefsey dati po koncu zdravljenja s hemodializo.
The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Na porazdelitev tenofoviralafenamida v telesu lahko vplivata dejavnost OATP1B1 in OATP1B3.
Hepatitis B and/or hepatitis C virus co-infection The pharmacokinetics of emtricitabine, rilpivirine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus.
Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C Farmakokinetične lastnosti emtricitabina, rilpivirina in tenofoviralafenamida pri bolnikih s hkratno okužbo z virusom hepatitisa B in/ali C niso v celoti ovrednotili.
In a study comparing 8 patients with mild hepatic impairment (Child-Pugh Class A) to 8 matched controls and 8 patients with moderate hepatic impairment (Child-Pugh Class B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
V študiji so primerjali 8 bolnikov z blago jetrno okvaro (stopnje A po Child-Pughu) z 8 ustreznimi kontrolnimi preiskovanci in 8 bolnikov z zmerno jetrno okvaro (stopnje B po Child-Pughu) z 8 ustreznimi kontrolnimi preiskovanci, pri čemer je bila izpostavljenost rilpivirinu iz več odmerkov za 47 % višja pri bolnikih z blago jetrno okvaro in 5 % višja pri bolnikih z zmerno jetrno okvaro.
Discontinuation of Odefsey therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Odefsey pri bolnikih s hkratno okužbo s HIV in virusom HBV je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1).
Poročali niso o nobenih laboratorijskih anomalijah stopnje 3-4 za AST/ALT ali neželenih učinkov z zvišanjem transaminaz stopnje 3-4 (glejte poglavje 5.1).
Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum.
Rilpivirin (ena od učinkovin zdravila Odefsey) v kombinaciji z osnovno shemo zdravljenja je bil ocenjen v študiji TMC114HIV3015 pri 19 nosečnicah med 2. in 3. trimesečjem in po porodu.
Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet.
Siva filmsko obložena tableta v obliki kapsule, z dimenzijami 15 mm x 7 mm, z vtisnjenim znakom „GSI“ na eni strani tablete in „255“ na drugi strani tablete.
Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
Po podatkih iz študij medsebojnega delovanja, opravljenih z učinkovinami zdravila Odefsey, se ne pričakujejo nobena klinično pomembna medsebojna delovanja, kadar se zdravilo Odefsey uporablja v kombinaciji z naslednjimi zdravili: buprenorfin, nalokson in norbuprenorfin.
• If you notice within 12 hours of the time you usually take Odefsey, you must take the tablet as soon as possible.
• Če to opazite v roku 12 ur od časa, ko zdravilo Odefsey običajno vzamete, morate tableto vzeti čim prej.
A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp).
Tveganja za povečanje koncentracij dabigatrana v plazmi ni mogoče izključiti (zaviranje črevesnega P-gp).
In Studies GS-US-292-0104 and GS-US-292-0111, the rate of virologic success was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA, or baseline CD4+ cell count).
V študijah GS-US-292-0104 in GS-US-292-0111, je bila stopnja virološke uspešnosti podobna pri vseh podskupinah bolnikov (starost, spol, rasa, začetna vrednost HIV-1 RNA ali začetno število celic CD4+).
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 < 4 % in je neodvisna od koncentracije v razponu med 0,02-200 µg/ml.
Odefsey has not been studied in patients with severe hepatic impairment (Child Pugh Class C); therefore, Odefsey is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Zdravila Odefsey niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po Child-Pughu); zato se uporaba zdravila Odefsey pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Odefsey and development of resistance.
Pričakuje se, da zdravila, ki inducirajo aktivnost P-gp (npr. rifampicin, rifabutin, karbamazepin, fenobarbital), zmanjšajo absorpcijo tenofoviralafenamida, kar povzroči zmanjšanje koncentracije tenofoviralafenamida v plazmi ter lahko povzroči izgubo terapevtskega učinka zdravila Odefsey in razvoj rezistence.
Fifty-two percent of HIV-1 isolates with emergent resistance in the rilpivirine arm developed concomitant NNRTI and NRTI mutations, most frequently E138K and M184V.
Dvainpetdeset odstotkov izolatov HIV-1 z nastalo rezistenco v kraku z rilpivirinom je razvilo sočasne mutacije NNRTI in NRTI, najpogosteje E138K in M184V.
Clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
saj je morda pri nekaterih bolnikih treba prilagoditi vzdrževalno zdravljenje z metadonom.
What Odefsey is and what it is used for What you need to know before you take Odefsey How to take Odefsey
Kaj je zdravilo Odefsey in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Odefsey Kako jemati zdravilo Odefsey Možni neželeni učinki
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Odefsey.
Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti tenofoviralafenamidu in tenofovirju, ki je bila približno 4-krat oz. 17-krat večja od pričakovane po dajanju zdravila Odefsey.
Odefsey contains lactose
Zdravilo Odefsey vsebuje laktozo
Patients co-infected with HIV and hepatitis B or C virus
Bolniki s hkratno okužbo z virusom HIV in virusom hepatitisa B ali C
• If you are currently taking any of the following medicines: - carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures) - rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
• Če trenutno uporabljate katero koli od naslednjih zdravil: karbamazepin, okskarbazepin, fenobarbital in fenitoin (zdravila za zdravljenje epilepsije in preprečevanje epileptičnih napadov) rifabutin, rifampicin in rifapentin (uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza)
Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Zdravljenje z zdravilom Odefsey je treba prekiniti pri bolnikih z ocenjenim CrCl, ki med zdravljenjem pade pod 30 ml/min (glejte poglavje 5.2).
If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Če ste pomotoma zaužili odmerek zdravila Odefsey, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).