natgillin/translations-raw huggingface dataset:
When emtricitabine (one of the components of Eviplera) was administered to paediatric patients, the following adverse reactions were observed more frequently in addition to the adverse reactions reported in adults: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients (see section 4.8, Tabulated summary of adverse reactions).
Kada je emtricitabin (jedna od djelatnih tvari lijeka Eviplera) primijenjen pedijatrijskim bolesnicima, sljedeće nuspojave su zabilježene učestalije uz nuspojave zabilježene kod odraslih osoba: anemija je bila česta (9,5%) i promjena boje kože (pojačana pigmentacija) je bila vrlo česta (31,8%) u pedijatrijskih bolesnika (vidjeti dio 4.8, Tablični sažetak nuspojava).
There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
U odraslih zaraženih virusom HIV-1 nije bilo novih sigurnosnih podataka u usporedbi s poznatim profilom sigurnosti rilpivirina (vidjeti dijelove 4.2, 4.4 i 5.2).
Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Abnormalnosti kostiju (koje rijetko pridonose prijelomima) mogu biti povezane s proksimalnom bubrežnom tubulopatijom (vidjeti dio 4.8).
Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
U farmakodinamičkim ispitivanjima, emtricitabin i tenofovir pokazali su djelovanje protiv HBV-a pojedinačno i u kombinaciji (vidjeti dio 5.1).
Considering all of the available in vitro data and data generated in previously untreated patients, the following resistance-associated mutations in HIV-1 RT, when present at baseline, may affect the activity of Eviplera: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L and the combination of L100I and K103N.
Uzimajući u obzir sve dostupne in vitro podatke i podatke dobivene od bolesnika koji prethodno nisu bili liječeni, na djelovanje lijeka Eviplera mogu utjecati sljedeće mutacije HIV-1 RT povezane s rezistencijom, kad su prisutne na početku: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L i kombinacija L100I i K103N.
Antacids (e.g. aluminium or magnesium hydroxide, calcium carbonate)
Antacidi (npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat)
Resistance to rilpivirine2 Cross-resistance3 to etravirine efavirenz nevirapine
Križna rezistencija3 na etravirin efavirenz nevirapin
Eviplera 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).
Eviplera se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil, tenofoviralafenamid ili druge analoge citidina, kao što je lamivudin (vidjeti dio 4.5).
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
Discontinued study drug due to AE or deathd
Prekid primjene ispitivanog lijeka zbog nuspojave ili smrtid
HIV patients with liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Bolesnici s HIV-om s bolešću jetre (uključujući kronični hepatitis B ili C), koji se liječe antiretrovirusnim lijekovima, izloženi su većem riziku od pojave teških i potencijalno životno opasnih komplikacija s jetrom.
Lower exposures of rilpivirine (one of the components of Eviplera) were observed during pregnancy; therefore viral load should be monitored closely.
Tijekom trudnoće opažene su manje izloženosti rilpivirinu (jedna od komponenti lijeka Eviplera); stoga je potrebno pažljivo pratiti virusno opterećenje.
Virologic response to tenofovir disoproxil was not reduced in patients with HIV-1 that expressed the abacavir/emtricitabine/lamivudine resistance-associated M184V substitution.
Virološki odgovor na tenofovirdizoproksil nije bio smanjen u bolesnika s HIV-1 koji je izražavao supstituciju M184V povezanu s rezistencijom na abakavir/emtricitabin/lamivudin.
Sofosbuvir/Emtricitabine
Sofosbuvir/emtricitabin
Eviplera contains lactose and sunset yellow aluminium lake (E110)
Eviplera sadrži laktozu i boju sunset yellow aluminium lake (E110)
• If you notice within 12 hours of the time you usually take Eviplera, you must take the tablet as soon as possible.
• Ako to primijetite a prošlo je manje od 12 sati od vremena kad obično uzimate Evipleru, tabletu morate uzeti što prije.
In treatment-naïve patients, the most frequently reported adverse reactions considered possibly or probably related to rilpivirine hydrochloride and emtricitabine/tenofovir disoproxil were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%) (pooled data from the Phase III clinical studies C209 and C215, see section 5.1).
U bolesnika koji prethodno nisu bili liječeni, najčešće zabilježene nuspojave za koje se smatra da su moguće ili vjerojatno povezane s rilpivirinkloridom i emtricitabinom/tenofovirdizoproksilom bile su mučnina (9%), omaglica (8%), abnormalni snovi (8%), glavobolja (6%), proljev (5%) i nesanica (5%) (objedinjeni podaci iz kliničkih ispitivanja III. faze C209 i C215, vidjeti dio 5.1).
There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B).
Postoje ograničene informacije o primjeni lijeka Eviplera u bolesnika s blagim ili umjerenim oštećenjem jetre (Child-Pugh-Turcotte (CPT) stadij A ili B).
Of the 469 Eviplera-treated patients [317 patients who switched to Eviplera at baseline (Eviplera arm) and 152 patients who switched at week 24 (Delayed Switch arm)], a total of 7 patients were analysed for resistance development and all had genotypic and phenotypic data available.
Od 469 bolesnika liječenih lijekom Eviplera [317 bolesnika prebačenih na lijek Eviplera na početku (skupina na lijeku Eviplera) i 152 bolesnika koji su se prebacili u 24. tjednu (skupina s kasnim prebacivanjem)], analiza na razvoj rezistencije provedena je u ukupno 7 bolesnika i svi su imali dostupne genotipske i fenotipske podatke.
Emtricitabine exposures were not affected by food.
Hrana nije utjecala na izloženost emtricitabinu.
In virologically suppressed HIV-1 infected patients In study GS-US-264-0106, 4 of the 469 patients who switched from a ritonavir-PI-based regimen to Eviplera had HIV-1 with reduced susceptibility to at least one component of Eviplera through week 48.
U ispitivanju GS-US-264-0106, 4 od 469 bolesnika prebačenih s režima ritonavirom pojačanim IP na lijek Eviplera imalo je HIV-1 sa smanjenom osjetljivošću na barem jednu komponentu lijeka Eviplera do 48. tjedna.
H2-RECEPTOR ANTAGONISTS Famotidine/Emtricitabine
ANTAGONISTI H2-RECEPTORA
The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Antivirusno djelovanje tenofovira protiv laboratorijskih i kliničkih izolata HIV-1 procijenilo se na limfoblastoidnim staničnim linijama, primarnim monocitnim/makrofagnim stanicama i limfocitima periferne krvi.
Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Farmakokinetički parametri određeni su uglavnom nakon primjene jednokratnih doza od 200 mg emtricitabina ili 245 mg tenofovirdizoproksila kod bolesnika koji nisu bili inficirani virusom HIV-a, a imali su različiti stupanj oštećenja bubrega.
Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, and triacetin.
Film-ovojnica: hipromeloza, boja indigo carmine aluminium lake, laktoza hidrat, polietilenglikol, crveni željezov oksid, boja sunset yellow aluminium lake (E110), titanijev dioksid i triacetin.
7 This adverse reaction was identified through post-marketing surveillance for Eviplera (fixed-dose combination) but not observed in randomised controlled clinical studies for Eviplera.
7 Ova nuspojava bila je identificirana tijekom praćenja lijeka Eviplera nakon stavljanja lijeka u promet (kombinacija s fiksnom dozom) no nije zabilježena u randomiziranim kontroliranim kliničkim ispitivanjima za lijek Eviplera.
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja liječenja CARTom mogu nastati upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
The combination of emtricitabine, rilpivirine and tenofovir disoproxil has been studied as the component products in treatment-naïve patients (Phase III studies C209 and C215).
Kombinacija emtricitabina, rilpivirina i tenofovirdizoproksila ispitana je njihovom primjenom kao zasebnih lijekova u bolesnika koji prethodno nisu bili liječeni (ispitivanja III. faze C209 i C215).
Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil on fertility.
Ispitivanja na životinjama ne ukazuju da emtricitabin, rilpivirinklorid ili tenofovirdizoproksil imaju štetan učinak na plodnost.
Eviplera should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil or tenofovir alafenamide.
Eviplera se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil ili tenofoviralafenamid.
Interaction not studied with any components of Eviplera.
Interakcija nije ispitana ni s jednom komponentom lijeka Eviplera.
Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosinerelated adverse reactions.
Istovremena primjena tenofovirdizoproksila i didanozina rezultira 40 - 60% -tnim povećanjem sistemske izloženosti didanozinu, što može povećati rizik od nuspojava povezanih s didanozinom.
Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components
Tablica 2: Tablični sažetak nuspojava na lijek Eviplera na temelju kliničkog ispitivanja i iskustva nakon stavljanja lijeka u promet lijeka Eviplera i njegovih pojedinačnih djelatnih tvari
• Other medicines used for HIV infection: Non-nucleoside reverse transcriptase inhibitors (NNRTIs).
• Drugi lijekovi za liječenje HIV-infekcije: Nenukleozidni inhibitori reverzne transkriptaze (NNRTI).
• omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (proton pump inhibitors that are medicines used to prevent and treat stomach ulcers, heartburn, acid reflux disease)
• omeprazol, lanzoprazol, rabeprazol, pantoprazol i ezomeprazol (inhibitori protonske pumpe, a to su lijekovi koji se primjenjuju za sprječavanje i liječenje čireva želuca, žgaravice i bolesti vraćanja želučane kiseline)
Use of Eviplera should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Primjenu lijeka Eviplera treba izbjegavati kod istovremene ili nedavne primjene nefrotoksičnih lijekova (vidjeti dio 4.5).
Patients were randomised in a 1:1 ratio to receive either rilpivirine hydrochloride 25 mg (n = 686) once daily or efavirenz 600 mg (n = 682) once daily in addition to a BR.
Bolesnici su bili randomizirani u omjeru 1:1 u skupinu koja je primala rilpivirinklorid 25 mg (n = 686) jedanput na dan i skupinu koja je primala efavirenz 600 mg (n = 682) jedanput na dan uz osnovni terapijski režim.
• Yellow skin or eyes, itching or pain in the abdomen (tummy) caused by inflammation of the liver
• žuta boja kože ili očiju, svrbež ili bol u trbuhu prouzročen upalom jetre
In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir and lamivudine.
Osim toga, supstitucija K70E u HIV-1 RT selektivno je izdvojena tenofovirom i dovela je do niske razine smanjene osjetljivosti na abakavir, emtricitabin, tenofovir i lamivudin.
• the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• antikonvulzivi karbamazepin, okskarbazepin, fenobarbital, fenitoin
• Decreases in phosphate levels in the blood
• snižene razine fosfata u krvi
Patients were switched from efavirenz/emtricitabine/tenofovir disoproxil to Eviplera without a washout period.
Bolesnici su bili prebačeni s efavirenza/emtricitabina/tenofovirdizoproksila na Evipleru bez razdoblja ispiranja prethodno uzimanih lijekova.
The pharmacokinetics of emtricitabine has not been studied in patients with varying degrees of hepatic insufficiency.
Farmakokinetika emtricitabina nije ispitana u bolesnika s različitim stupnjevima jetrene insuficijencije.
Eviplera should not be co-administered with the following medicinal products as significant decreases in rilpivirine plasma concentrations may occur (due to cytochrome P450 [CYP]3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Eviplera:
Eviplera se ne smije istovremeno primjenjivati sa sljedećim lijekovima, jer mogu nastati značajna smanjenja koncentracije rilpivirina u plazmi (zbog indukcije enzima citokroma P450 [CYP]3A ili povišenja želučanog pH), što može rezultirati gubitkom terapijskog učinka lijeka Eviplera:
There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse event (TEAE).
U skupini na lijeku Eviplera bilo je 7/317 bolesnika (2%), a u skupini s odgođenim prebacivanjem 6/152 (4%) bolesnika koji su trajno prekinuli uzimanje ispitivanog lijeka zbog štetnog događaja koji se pojavio uz liječenje.
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Uslijed oštećenja stanica bubrežnih kanalića može doći do razlaganja mišića, omekšavanja kostiju (uz bolove u kostima i katkad lomove), bolova u mišićima, slabosti mišića i smanjenja koncentracije kalija ili fosfata u krvi.
In the week 96 pooled resistance analysis for patients receiving emtricitabine/tenofovir disoproxil + rilpivirine hydrochloride in the Phase III clinical studies C209 and C215, there were 78 virologic failure patients with genotypic resistance information available for 71 of those patients.
U analizi objedinjenih podataka o rezistenciji iz 96. tjedna za bolesnike koji su primali emtricitabin/tenofovirdizoproksil + rilpivirinklorid u kliničkim ispitivanjima III. faze C209 i C215, u 78 bolesnika postojao je virološki neuspjeh, a genotipski podaci o rezistenciji bili su dostupni za 71 od tih bolesnika.
6 Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
6 Ispitivanje provedeno emtricitabinom/rilpivirinom/tenofoviralafenamidom u kombiniranoj tableti s fiksnom dozom.
Patients were randomised in a 2:1 ratio to either switch to Eviplera at baseline (Eviplera arm, n = 317), or stay on their baseline antiretroviral regimen for 24 weeks (SBR arm, n = 159) before switching to Eviplera for an additional 24 weeks (Delayed Switch arm, n = 152).
Bolesnici su bili randomizirani u omjeru 2:1 za prebacivanje ili na lijek Eviplera na početku (skupina na lijeku Eviplera, n=317) ili ostanak na svom početnom antiretrovirusnom režimu tijekom 24 tjedna (skupina ostala na početnom režimu liječenja, n=159) prije prebacivanja na lijek Eviplera tijekom dodatna 24 tjedna (skupina s kasnim prebacivanjem, n=152).
The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose adjustment is required in these patients.
Farmakokinetika tenofovira ispitana je u bolesnika s oštećenjem jetre i u tih bolesnika nije potrebna prilagodba doze.
However, long-term safety data for the emtricitabine and tenofovir disoproxil components of Eviplera have not been evaluated in patients with mild renal impairment.
Međutim, podaci o dugotrajnoj sigurnosti komponenti lijeka Eviplera, emtricitabina i tenofovirdizoproksila, nisu procijenjeni u bolesnika s blagim oštećenjem bubrega.
Table 7: Outcomes of randomised treatment in study GS-US-264-0106 at week 24a
Tablica 7: Ishodi randomiziranog liječenja u ispitivanju GS-US-264-0106 u 24. tjednua Skupina na lijeku Eviplera n = 317
There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Bilo je i reklasifikacija u 48. tjednu kad se radila primarna analiza, najčešće iz skupine virološkog neuspjeha u skupinu prekida liječenja zbog drugih razloga (ne zbog štetnog događaja).
The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to Eviplera STR was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Djelotvornost i sigurnost prebacivanja s ritonavirom pojačanog IP u kombinaciji s dva NRTI-ja na režim jednom tabletom lijeka Eviplera procijenjena je u randomiziranom, otvorenom ispitivanju u virološki suprimiranih odraslih bolesnika zaraženih virusom HIV-1.
Eviplera is not recommended for patients with moderate or severe renal impairment (CrCl < 50 mL/min).
Eviplera se ne preporučuje za bolesnike s umjerenim ili teškim oštećenjem bubrega (CrCl < 50 ml/min).
It is not known whether placental transfer of rilpivirine occurs in pregnant women.
Nije poznato prelazi li rilpivirin kroz plancentu u trudnica.
Rilpivirine hydrochloride at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Rilpivirinklorid u preporučenoj dozi od 25 mg jedanput na dan nije povezan s klinički važnim učinkom na QTc.
• emtricitabine
• emtricitabin
In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
U bolesnika koji su primali tenofovirdizoproksil zabilježeni su rijetki slučajevi oštećenja bubrega, zatajenja bubrega i manje česti slučajevi proksimalne bubrežne tubulopatije (uključujući Fanconijev sindrom), koji su ponekad doveli do abnormalnosti kostiju (rijetko pridonoseći prijelomima).
• Tiredness or drowsiness
• umor ili omamljenost
A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to CPT classification.
Jednokratna doza tenofovirdizoproksila od 245 mg dana je ispitanicima bez infekcije HIV-om, koji su imali različiti stupanj oštećenja funkcije jetre definiran prema klasifikaciji CPT.
Cytochrome P450 enzyme inhibitors
Inhibitori enzima citokroma P450
Patients with HIV and hepatitis B or C virus co-infection
Bolesnici s istovremenom infekcijom HIV-om i virusom hepatitisa B ili C
Talk to your doctor about an alternative regimen.
Porazgovarajte s liječnikom o drugačijem načinu uzimanja.
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/mL) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/mL).
Rilpivirin je također pokazao antivirusno djelovanje protiv širokog panela primarnih izolata HIV-1 skupine M (podtipovi A, B, C, D, F, G, H) uz vrijednosti EC50 u rasponu od 0,07 do 1,01 nM (0,03 do 0,37 ng/ml) i primarnih izolata skupine O uz vrijednosti EC50 u rasponu od 2,88 do 8,45 nM (1,06 do 3,10 ng/ml).
• Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI).
• Tenofovirdizoproksil, nukleotidni inhibitor reverzne transkriptaze (NtRTI).
However, patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Eviplera (see section 4.8).
Međutim, bolesnike treba obavijestiti da su tijekom liječenja djelatnim tvarima lijeka Eviplera zabilježeni umor, omaglica i somnolencija (vidjeti dio 4.8).
The most commonly observed resistanceassociated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Najčešće primijećene mutacije povezane s rezistencijom koje su se pojavile uključivale su L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C i M230I.
There is limited metabolism of emtricitabine.
Emtricitabin se ograničeno metabolizira.
Protease inhibitors (PIs) - boosted (with co-administration of low-dose ritonavir) Atazanavir/Ritonavir/Emtricitabine Interaction not studied.
Inhibitori proteaze (IP) - pojačani (istovremeno primijenjenom niskom dozom ritonavira) Atazanavir/ritonavir/emtricitabin
Among those patients who developed resistance to rilpivirine, 4/7 patients with baseline viral load ≤ 100,000 copies/mL and 28/30 patients with baseline viral load > 100,000 copies/mL had cross-resistance to other NNRTIs.
Među onima koji su razvili rezistenciju na rilpivirin, 4/7 bolesnika s početnim virusnim opterećenjem ≤ 100 000 kopija/ml i 28/30 bolesnika s početnim virusnim opterećenjem > 100 000 kopija/ml imalo je križnu rezistenciju na druge NNRTI-eve.
• Tell your doctor if you had kidney disease, or if tests have shown kidney problems.
• Obavijestite svog liječnika ako imate bolest bubrega ili ste imali tegobe s bubrezima.
• Changes to your urine
• promjene u mokraći
Through week 24, two patients who switched to Eviplera at baseline (2 of 317 patients, 0.6%) and one patient who maintained their ritonavir-boosted PI-based regimen [Stayed on Baseline Regimen (SBR) arm] (1 of 159 patients, 0.6%) developed genotypic and/or phenotypic resistance to study drugs.
Do 24. tjedna, dva bolesnika koji su se prebacili na lijek Eviplera na početku (2 od 317 bolesnika, 0,6%) i jedan bolesnik koji se održao na režimu ritonavirom pojačanim IP [skupina ostala na početnom režimu liječenja] (1 od 159 bolesnika, 0,6%) razvili su genotipsku i/ili fenotipsku rezistenciju na ispitivane lijekove.
In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
U bolesnika s uznapredovalom bolešću jetre ili cirozom ne preporučuje se prekid liječenja, budući da egzacerbacija hepatitisa nakon liječenja može dovesti do dekompenzacije jetre.
Hepatitis B and/or hepatitis C virus co-infection
Istovremena infekcija virusom hepatitisa B i/ili hepatitisa C
neutropenia1, decreased white blood cell count2, decreased haemoglobin2, decreased platelet count2
neutropenija1, smanjeni broj bijelih krvnih stanica2, sniženi hemoglobin2, smanjeni broj trombocita2
Eviplera should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Eviplera se treba primjenjivati s oprezom kad se istovremeno primjenjuju lijekovi s poznatim rizikom od torsade de pointes.