natgillin/translations-raw huggingface dataset:
The incidence of these selected endpoints for subjects on maraviroc in this observational phase was consistent with the incidence seen at earlier timepoints in the studies.
Pri osebah, ki so prejemale maravirok v tej opazovalni fazi, je bila incidenca teh opazovanih dogodkov v skladu z incidenco, opaženo v prejšnjih obdobjih opazovanja v študijah.
If you accidentally take or give too much CELSENTRI:
Če pomotoma vzamete ali date večji odmerek zdravila CELSENTRI:
Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and mouse bone marrow micronucleus.
Maravirok se ni izkazal za mutagenega ali genotoksičnega v skupini preizkusov in vitro in in vivo, vključno s preizkusom reverznih mutacij pri bakterijah, kromosomskih aberacij v človeških limfocitih in mikrojeder v mišjem kostnem mozgu.
These findings are considered of low human relevance.
Ti podatki niso posebej relevantni za človeka.
Use of maraviroc was not associated with a significant decrease in HIV 1 RNA compared with placebo in these subjects and no adverse effect on CD4+ cell count was noted.
Uporaba maraviroka pri teh preiskovancih ni bila povezana z bistvenim zmanjšanjem HIV1 RNA v primerjavi s placebom; neželenega učinka na število celic CD4+ niso ugotovili.
Patients with cardiovascular co-morbidities could be at increased risk of cardiovascular adverse reactions triggered by postural hypotension.
Bolniki s sočasnimi kardiovaskularnimi boleznimi imajo lahko večje tveganje za kardiovaskularne neželene učinke, ki jih izzove posturalna hipotenzija.
Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Filmska obloga: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, sojin lecitin, indigotin (E132).
Median peak maraviroc plasma concentrations are attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
Mediana največja koncentracija maraviroka v plazmi je dosežena po 2 urah (razpon od 0,5 do 4 ure) po posamičnem peroralnem zaužitju komercialno dostopne 300 mg tablete pri zdravih prostovoljcih.
• if you (or your child, if they are the patient) are allergic to maraviroc or to peanut or soya or to any of the other ingredients of CELSENTRI (listed in section 6 ).
• če ste vi (ali vaš otrok) alergični na maravirok ali arašide ali sojo oziroma katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
The pharmacokinetics of oral maraviroc are not dose proportional over the dose range.
Farmakokinetika peroralnega maraviroka v odmernem območju ni sorazmerna odmerku.
• an increase in a substance known as CPK (seen in blood test results) which is a sign that muscles are inflamed or damaged.
• povečana količina snovi, imenovane kreatin fosfokinaza (CPK - creatine phosphokinase, pokaže se na preiskavah krvi), ki je lahko znak vnetja ali poškodbe mišic.
Thus, CELSENTRI dose should be modified in line with the recommendation for co-administration with respective PI/ritonavir combination (see ‘Protease Inhibitors').
Odmerek zdravila CELSENTRI je treba prilagoditi skladno s priporočili za sočasno zdravljenje s kominacijo zaviralec proteaz (PI)/ritonavir (glejte zaviralci proteaz (PI)).
In mice, no statistically significant increase in the incidence of tumours was reported at systemic exposures from 7 to 39-times the human exposure (unbound AUC 0-24h measurement) at a dose of 300 mg twice daily.
Pri miših maravirok ni statistično pomembno povečal incidence nobene vrste tumorja pri sistemskih izpostavljenostih v območju od 7- do 39-kratne izpostavljenosti pri človeku (na podlagi merjenja nevezane AUC 0-24h) ob odmerku 300 mg dvakrat na dan.
• antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)
• antibiotike (klaritromicin, telitromicin, rifampicin, rifabutin),
Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2)
Preglednica 7: Delež bolnikov, ki so po 48 tednih dosegli < 50 kopij/ml po podskupinah (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2)
Primary pharmacological activity (CCR5 receptor affinity) was limited in the species studied (see section 5.3).
Pri raziskanih vrstah je bila primarna farmakološka aktivnost (afiniteta za CCR5 receptor) omejena (glejte poglavje 5.3).
The bottle contains 230 ml of maraviroc solution (20 mg/ml).
Plastenka vsebuje 230 ml raztopine maraviroka (20 mg/ml).
In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia.
Študije in vitro ter in vivo so pokazale, da ima maravirok v supraterapevtskih odmerkih potencial za podaljšanje intervala QT brez znakov aritmije.
Hypersensitivity reactions including severe and potentially life threatening events have been reported in patients taking maraviroc, in most cases concomitantly with other medicinal products associated with these reactions.
Pri bolnikih, ki so jemali maravirok, so bile opisane preobčutljivostne reakcije, vključno s hudimi in potencialno smrtno nevarnimi; večinoma so se pojavile sočasno z drugimi zdravili, ki so prav tako povezana s takšnimi reakcijami.
Discontinuation of maraviroc should be strongly considered in any patient with signs or symptoms of acute hepatitis, in particular if drug-related hypersensitivity is suspected or with increased liver transaminases combined with rash or other systemic symptoms of potential hypersensitivity (e.g. pruritic rash, eosinophilia or elevated IgE).
Prekinitev uporabe maraviroka pride močno v poštev pri bolnikih z znaki ali simptomi akutnega hepatitisa, zlasti če obstaja sum na preobčutljivost za zdravilo ali so jetrne transaminaze zvišane v kombinaciji z izpuščajem ali drugimi sistemskimi simptomi možne preobčutljivosti (npr. srbeč izpuščaj, eozinofilija ali zvišanje IgE).
The results did not indicate any relevant efficacy or safety concern related to either fed or fasted dosing conditions.
Rezultati ne kažejo pomembnih težav glede učinkovitosti ali varnosti ne v primeru jemanja na poln ne v primeru jemanja na prazen želodec.
Exposures observed in subjects with severe renal impairment and ESRD were within the range observed in single maraviroc 300 mg dose studies in healthy volunteers with normal renal function.
Izpostavljenosti, ugotovljene pri bolnikih s hudo okvaro ledvic in končno odpovedjo ledvic, so bile v razponu, zabeleženem v študijah enkratnega 300-mg odmerka maraviroka pri zdravih prostovoljcih z normalnim delovanjem ledvic.
In vitro studies have shown that maraviroc does not inhibit OATP1B1, MRP2 or any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4).
Študije In vitro so pokazale, da maravirok v klinično pomembnih koncentracijah ne zavira OATP1B1, MRP2 ali nobenega od pomembnih encimov P450 (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4).
Not studied, no interaction expected.
Ni raziskano, medsebojno delovanje ni pričakovano.
Changes in viral tropism occur over time in HIV-1 infected patients.
Pri bolnikih z okužbo s HIV-1 sčasoma pride do sprememb v tropizmu virusa.
The recommended dose of CELSENTRI is 150 mg (with potent CYP3A inhibitor with or without a potent CYP3A inducer), 300 mg (without potent CYP3A inhibitors or inducers) or 600 mg twice daily (with potent CYP3A inducer without a potent CYP3A inhibitor) depending on interactions with concomitant antiretroviral therapy and other medicinal products (see section 4.5).
Priporočeni odmerek zdravila CELSENTRI je 150 mg (z močnim zaviralcem CYP3A, z ali brez močnega induktorja CYP3A), 300 mg (brez močnih zaviralcev ali induktorjev CYP3A) ali 600 mg dvakrat na dan (z močnim induktorjem CYP3A, brez močnega zaviralca CYP3A), odvisno od interakcij s sočasnim protiretrovirusnim zdravljenjem ali z drugimi zdravili (glejte poglavje 4.5).
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Imetnik dovoljenja za promet z zdravilom ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Nizozemska.
Maraviroc had no clinically relevant effect on the pharmacokinetics of midazolam, the oral contraceptives ethinylestradiol and levonorgestrel, or urinary 6β-hydroxycortisol/cortisol ratio, suggesting no inhibition or induction of CYP3A4 in vivo.
Maravirok ni klinično pomembno vplival na farmakokinetiko midazolama, peroralnih kontraceptivov etinilestradiola in levonorgestrela, ali na razmerje med 6β-hidroksikortizolom in kortizolom v urinu, kar kaže na odsotnost zaviranja ali indukcije CYP3A4 in vivo.
Discard 60 days after first opening.
Zavrzite 60 dni po prvem odprtju.
Maraviroc belongs to a group of medicines called CCR5 antagonists.
Maravirok sodi v skupino zdravil, imenovanih antagonisti CCR5.
There is no data on the effects of maraviroc on human fertility.
O vplivu maraviroka na plodnost pri ljudeh ni podatkov.
It is unknown whether maraviroc is excreted in human milk.
Ni znano, ali se maravirok pri človeku izloča v materino mleko.
One subject in each treatment arm met the primary endpoint by Week 48 (at Week 8 for placebo and Week 36 for the maraviroc arm).
Primarni opazovani dogodek je do 48. tedna v vsaki terapevtski skupini dosegel po en preiskovanec (v 8. tednu v skupini s placebom in v 36. tednu v skupini z maravirokom).
In treatment-naïve patients, the incidence of grade 3 and 4 laboratory abnormalities using ACTG criteria was similar among the maraviroc and efavirenz treatment groups.
Pri še nezdravljenih bolnikih je bila incidenca laboratorijskih nenormalnosti 3. in 4. stopnje po merilih ACTG v terapevtski skupini z maravirokom in v terapevtski skupini z efavirenzem podobna.
In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics.
Poleg tega sočasna uporaba maraviroka z lamivudinom/zidovudinom ni pokazala, da bi maravirok vplival na farmakokinetiko lamivudina (ki se izloči predvsem skozi ledvice) ali zidovudina (presnova, ki ne poteka s P450, in izločanje skozi ledvice).
The remainder was excreted as metabolites.
Preostanek se je izločil v obliki presnovkov.
Symptoms may include:  muscle weakness  weakness beginning in the hands and feet and moving up towards the trunk of the body  palpitations or tremor  hyperactivity (excessive restlessness and movement).
 šibkost mišic,  oslabelost, ki se začne v dlaneh in stopalih in se pomika proti trupu,  razbijanje srca (palpitacije) ali tresenje (tremor),  hiperaktivnost (pretiran nemir in gibanje).
Hypersensitivity to the active substance or to peanut or soya or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
The initial dose of maraviroc was scaled from adult doses using a body surface area (BSA) of 1.73 m2 to children and adolescent BSA (m2)-based bands.
Začetni odmerek maraviroka je bil preračunan iz odmerka za odrasle na podlagi telesne površine 1,73 m na pasove (m2) telesne površine za otroke in mladostnike.
Refer to the Package Leaflets of these other medicines for guidance on how to take them.
Glede napotkov za uporabo teh drugih zdravil glejte njihova navodila za uporabo.
• itraconazole, voriconazole, clarithromycin and telithromycin,
• itrakonazol, vorikonazol, klaritromicin in telitromicin,
Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Maravirok sodi v terapevtsko skupino, imenovano antagonisti CCR5.
Co-administration of a 300 mg tablet with a high fat breakfast reduced maraviroc Cmax and AUC by 33% and co-administration of 75 mg of oral solution with a high fat breakfast reduced maraviroc AUC by 73% in adult healthy volunteers.
Zaužitje 300 mg tablete hkrati z zajtrkom z visoko vsebnostjo maščob je pri zdravih odraslih prostovoljcih znižalo Cmax in AUC maraviroka za 33 %, zaužitje 75 mg peroralne raztopine z zajtrkom z visoko vsebnostjo maščob pa je zmanjšalo AUC maraviroka za 73 %.
Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc.
Ena filmsko obložena tableta vsebuje 25 mg, 75 mg, 150 mg ali 300 mg maraviroka.
The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL).
Cpovp maraviroka od 24 do 48 ur je bila pri bolnikih z zmerno okvaro ledvic majhna (Cpovp: 32,8 ng/ml).
Percentage of patients with HIV-1 RNA <50 copies/mL
Odstotek bolnikov s HIV-1 RNA < 50 kopij/ml
In addition, dosing was based on whether subjects were receiving potent CYP3A inhibitors (38/50), potent CYP3A inducers (2/50) or other concomitant medicinal products that are not potent CYP3A inhibitors or potent CYP3A inducers (10/50) as part of OBT.
Poleg tega je bilo pri odmerjanju upoštevano, ali preiskovanec kot del OOT prejema močne zaviralce CYP3A (38/50), močne induktorje CYP3A (2/50) ali druga sočasna zdravila, ki niso močni zaviralci ali močni induktorji CYP3A (10/50).
Table 4: Incidence ≥1% of grade 3-4 abnormalities (ACTG criteria) based on maximum shift in laboratory test values without regard to baseline studies MOTIVATE 1 and MOTIVATE 2 (pooled analysis, up to 48 weeks)
Preglednica 4: Nenormalnosti 3. in 4. stopnje (merila ACTG), ki so imele incidenco ≥ 1 %, na podlagi največje spremembe vrednosti laboratorijskih preiskav, ne glede na izhodiščne vrednosti; študiji MOTIVATE 1 in MOTIVATE 2 (kumulativna analiza, do 48 tednov)
The adverse reaction profile in paediatric patients is based on 48 Week safety data from study A4001031 in which 103 HIV-1 infected, treatment-experienced patients aged 2 to <18 years received maraviroc twice-daily with optimised background therapy (OBT).
Značilnosti neželenih učinkov pri pediatričnih bolnikih temeljijo na 48-tedenskih podatkih o varnosti iz študije A4001031 v kateri so 103 s HIV-1 okužene in predhodno že zdravljene bolnike, stare od 2 do vključno 18 let, zdravili z maravirokom dvakrat na dan ob optimizirani osnovni terapiji (OOT).
Before taking CELSENTRI it has to be confirmed that only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample.
Pred uporabo zdravila CELSENTRI je treba potrditi, da je prisoten le CCR5-tropni HIV-1 (tj. da ni ugotovljen CXCR4- ali dualno/mešano-tropni virus); za potrditev je treba uporabiti ustrezno validirano in občutljivo metodo odkrivanja ter svež vzorec krvi.
The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1).
V kliničnih študijah zdravila CELSENTRI so uporabljali Monogramov preskus Trofile (glejte poglavji 4.4 in 5.1).
Ribavirin has not been studied, no interaction is expected.
Ribavirin ni raziskan; medsebojno delovanje ni pričakovano.
This risk is due to potential increases in maraviroc maximum concentrations when maraviroc is co-administered with potent CYP3A inhibitors or boosted PIs in these patients.
To tveganje je posledica možnega povečanja največje koncentracije maraviroka, če je maravirok pri teh bolnikih uporabljen hkrati z močnimi zaviralci CYP3A ali okrepljenimi zaviralci proteaz.
Tell your doctor or pharmacist if you (or your child) begin taking a new medicine while taking CELSENTRI.
Zdravniku ali farmacevtu morate povedati, če boste vi (ali vaš otrok) začeli jemati novo zdravilo, medtem ko jemljete zdravilo CELSENTRI.
Table 4 shows the incidence ≥1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values.
Preglednica 4 prikazuje nenormalnosti 3. in 4. stopnje (merila ACTG), ki so imele incidenco ≥ 1 %, na podlagi največje spremembe vrednosti laboratorijskih preiskav, ne glede na izhodiščne vrednosti.
Concomitant use of CELSENTRI and fosamprenavir/ritonavir is not recommended.
Sočasna uporaba zdravila CELSENTRI in fosamprenavirja/ritonavirja ni priporočljiva.
Many medicines have profound effects on maraviroc exposure due to drug-drug interactions.
Številna zdravila zaradi medsebojnega delovanja močno vplivajo na izpostavljenost maraviroku.
In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
Študije in vitro kažejo, da je CYP3A4 glavni encim, odgovoren za presnovo maraviroka.
Maraviroc Cmax: ↑ compared to historical controls Nevirapine concentrations not measured, no effect is expected.
Maravirok AUC12: ↔ v primerjavi s kontrolnimi osebami iz preteklosti Maravirok Cmax: ↑ v primerjavi s kontrolnimi osebami iz preteklosti Koncentracija nevirapina ni bila merjena, učinki niso pričakovani.
Dispose of any unused oral solution 60 days after first opening the bottle.
Neuporabljeno peroralno raztopino zavrzite 60 dni po prvem odprtju plastenke.
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.
Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe kombinirane protiretrovirusne terapije (KPRT) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične okužbe.
Tipranavir/ritonavir concentrations were consistent with historical data.
Koncentracija tipranavirja/ritonavirja je bila skladna s podatki iz preteklosti.
Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu ali nalepki plastenke.
HERBAL PRODUCTS St. John's Wort (Hypericum Perforatum)
ZDRAVILA RASTLINSKEGA IZVORA Šentjanževka (Hypericum perforatum)
• yellowing of skin or eyes
• porumenelost kože ali očesnih beločnic,
Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the PI, saquinavir.
Proti maraviroku odporni virusi, ki so se pojavili in vitro, so ostali občutljivi za zaviralec fuzije enfuvirtid in zaviralec proteaz sakvinavir.
Turn the bottle upside down.
Obrnite plastenko tako, da bo pokonci.
In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe kombinirane protiretrovirusne terapije (KPRT) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene ter povzroči resna klinična stanja ali poslabšanje simptomov.
In the pivotal studies (MOTIVATE 1 and MOTIVATE 2), 7.6% of patients had a change in tropism result from CCR5-tropic to CXCR4-tropic or dual/mixed-tropic between screening and baseline (a period of 4-6 weeks).
V ključnih študijah (MOTIVATE 1 in MOTIVATE 2) je od presejanja do izhodišča (obdobje od 4 do 6 tednov) pri 7,6 % bolnikov prišlo do spremembe tropizma od CCR5-tropizma v CXCR4-tropizem ali dualni/mešani tropizem.
For combination with etravirine + PI, see below.
Za kombinacije z etravirinom in zaviralci proteaz glejte spodaj.
How to take CELSENTRI
Kako jemati zdravilo CELSENTRI
Assessment of treatment related adverse reactions is based on pooled data from two Phase 2b/3 studies in treatment-experienced adult patients (MOTIVATE 1 and MOTIVATE 2) and one study in treatment-naïve adult patients (MERIT) infected with CCR5-tropic HIV-1 (see sections 4.4 and
Ocena z zdravljenjem povezanih neželenih učinkov temelji na podatkih dobljenih v dveh študijah faze 2b/3 pri že zdravljenih odraslih bolnikih (MOTIVATE 1 in MOTIVATE 2) in eni študiji pri še nezdravljenih odraslih bolnikih (MERIT), okuženih s CCR5-tropnim virusom HIV-1 (glejte poglavji 4.4 in 5.1).
CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
CELSENTRI 25 mg filmsko obložene tablete EU/1/07/418/011
Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine.
Maravirok je zmerno vezan na beljakovine, zato lahko pri njegovem odstranjevanju koristi dializa.
Screening Viral Load >100,000 copies/mL Baseline CD4+ Cell Count ≤200 cells/mm3 Number (Percentage) of patients with GSS score1:
Presejalno virusno breme > 100.000 kopij/ml Izhodiščno število celic CD4+ ≤ 200 celic/mm Število (odstotek) bolnikov s seštevkom GSS1:
Do not use CELSENTRI after the expiry date which is stated on the bottle and carton label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in nalepki škatle.
If you get any of the following symptoms while you're taking CELSENTRI :  swelling of the face, lips or tongue  difficulty breathing  widespread skin rash  fever (high temperature)  blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
 oteklost obraza, ustnic ali jezika,  težko dihanje,  razširjen kožni izpuščaj,  zvišana telesna temperatura (vročina),  mehurji in lupljenje kože, zlasti okrog ust, nosu, oči in spolovil.
The exposure at this dose level corresponded to 39-fold the estimated free clinical AUC for a 300 mg twice daily dose.
Izpostavljenost pri tej odmerni ravni ustreza 39-kratni ocenjeni prosti klinični AUC pri odmerku 300 mg dvakrat na dan.
The mean CD4+ cell count (percent) increase from baseline to Week 48 was 247 cells/mm3 (5%).
(odstotka) celic CD4+ od izhodišča do 48. tedna je bilo 247 celic/mm3 (5 %).
The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Klinično učinkovitost delovanja maraviroka (v kombinaciji z drugimi protiretrovirusnimi zdravili) na raven HIV RNA v plazmi in število celic CD4+ so raziskali v dveh ključnih randomiziranih dvojno slepih multicentričnih študijah (MOTIVATE 1 in MOTIVATE 2, n = 1076 ) pri bolnikih, okuženih s CCR5-tropnim HIV-1 (ugotovljeno z Monogramovim preskusom Trofile).
• kidney problems.
• težave z ledvicami.
Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA <400 copies/mL
Povprečna sprememba od izhodišča (log kopij/ml) Odstotek bolnikov s HIV-1 RNA < 400 kopij/ml
In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Poleg tega so v študijah predhodno zdravljenih, s HIV okuženih bolnikov, ob maraviroku zabeležili več neželenih učinkov na jetra, niso pa se v celoti povečali nenormalni izvidi testov jetrne funkcije 3. oz. 4. stopnje po ACTG (glejte poglavje 4.8).
Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Preglednica 6: Izidi učinkovitosti po 48 tednih (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2)
The difference in maraviroc exposure between CYP3A5 extensive and poor metabolisers was reduced when maraviroc was administered together with a strong CYP3A inhibitor: extensive CYP3A5 metabolisers (n=12) had a 17% lower maraviroc AUC compared with poor CYP3A5 metabolisers (n=11) when dosed with maraviroc 150 mg once daily in the presence of darunavir/cobicistat (800/150 mg).
Razlika v izpostavljenosti maraviroku med izdatnimi in slabimi metabolizatorji s CYP3A5 se je zmanjšala, če je bil maravirok uporabljen skupaj z močnim zaviralcem CYP3A: izdatni metabolizatorji s CYP3A5 (n = 12) so imeli 17 % manjšo AUC maraviroka v primerjavi z slabimi metabolizatorji s CYP3A5 (n = 11), če je bil odmerek 150 mg maraviroka enkrat na dan uporabljen v prisotnosti kombinacije darunavir/kobicistat (800/150 mg).
ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
ANTIEPILEPTIKI Karbamezepin, fenobarbital, fenitoin