natgillin/translations-raw huggingface dataset:
In the pivotal studies of treatment-experienced patients coronary heart disease events were more common in patients treated with maraviroc than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up).
U pivotalnim studijama prethodno liječenih bolesnika događaji koronarne bolesti srca bili su češći u bolesnika liječenih maravirokom nego u bolesnika na placebu (11 slučajeva tijekom 609 PY naspram 0 slučajeva tijekom 111 PY ili tijekom razdoblja praćenja).
Maraviroc may have a minor influence on the ability to drive and use machines.
Maravirok može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
Elvitegravir per se is not expected to affect maraviroc exposure to a clinically relevant degree and the observed effect is attributed to ritonavir.
Ne očekuje se da će elvitergavir sam po sebi utjecati na izloženost maraviroku u klinički značajnoj mjeri, pa se primijećeni učinak pripisuje ritonaviru.
Please also refer to the respective Summary of Product Characteristics of the other antiretroviral medicinal products used in the combination.
Molimo također obratiti pozornost na odgovarajuće Sažetke opisa svojstava lijeka drugih antiretrovirusnih lijekova koji se primjenjuju u kombinaciji.
Signs to look out for include:
Znakovi na koje trebate obratiti pažnju uključuju:
BSA (m2)-based bands have been modified to weight (kg)-based bands to simplify dosing and reduce dosing errors (see section 4.2).
Kategorije utemeljene na tjelesnoj površini (m2) pretvorene su u kategorije prema tjelesnoj težini (kg) kako bi se olakšalo doziranje i smanjile pogreške pri doziranju (vidjeti dio 4.2).
Children from 2 years of age and weighing at least 10kg The recommended dose of CELSENTRI should be based on body weight (kg) and should not exceed the recommended adult dose.
Djeca u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg Preporučena doza lijeka CELSENTRI treba se temeljiti na tjelesnoj težini (kg) i ne smije biti veća od preporučene doze za odrasle.
• if you (or your child, if they are the patient) are allergic to maraviroc or to any of the other ingredients of CELSENTRI (listed in section 6 ).
• ako ste Vi (ili Vaše dijete, ako je ono bolesno) alergični na maravirok ili neki drugi sastojak lijeka CELSENTRI (naveden u dijelu 6.).
The Long Term Safety/Selected Endpoints (LTS/SE) included death, AIDS-defining events, hepatic failure, Myocardial infarction/cardiac ischaemia, malignancies, rhabdomyolysis and other serious infectious events with maraviroc treatment.
Long Term Safety/Selected Endpoints, LTS/SE) uključivale su smrt, događaje koji ukazuju na AIDS, zatajenje jetre, infarkt miokarda/srčanu ishemiju, zloćudne bolesti, rabdomiolizu i druge ozbiljne infekcije koje se javljaju kod liječenja maravirokom.
There were no food restrictions in the adult studies (using tablet formulations) or in the paediatric study (using both tablet and oral solution formulations).
Nije bilo nikakvih ograničenja u prehrani tijekom ispitivanja u odraslih (u kojima su se primjenjivale tablete) ni tijekom ispitivanja u pedijatrijskih bolesnika (u kojima su se primjenjivale i tablete i oralna otopina).
Maraviroc did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats up to 1000 mg/kg.
Maravirok nije utjecao na sposobnost parenja, plodnost mužjaka i ženki štakora niti je imao učinka na spermu mužjaka tretiranih dozama do 1000 mg/kg.
• ritonavir-boosted protease inhibitors (with the exception of tipranavir/ritonavir),
• inhibitori proteaza pojačani ritonavirom (osim tipranavira/ritonavira)
There are no data available to recommend a specific dose in paediatric patients with renal impairment.
Nema dostupnih podataka na temelju kojih bi se preporučila specifična doza za pedijatrijske bolesnike s oštećenjem bubrega.
Sparse pharmacokinetics were evaluated in all subjects including the additional 47 subjects receiving potent CYP3A inhibitors that did not take part in the dose-finding stage.
Povremeno ocjenjivanje farmakokinetike provodilo se u svih ispitanika, uključujući dodatnih 47 ispitanika koji su primali snažne inhibitore CYP3A, a nisu sudjelovali u dijelu ispitivanja u kojem se utvrđivala doza.
Therefore there is a need to start therapy shortly after a tropism test.
Zbog toga liječenje treba započeti u kratkom vremenu nakon utvrđivanja tropizma virusa.
If uncertainty still exists, contact a pharmacist for advice.
Ako i dalje niste sigurni, obratite se ljekarniku za savjet.
Therefore, despite differences in CYP3A5 genotype prevalence by race, the effect of CYP3A5 genotype on maraviroc exposure is not considered clinically significant and no maraviroc dose adjustment according to CYP3A5 genotype, race or ethnicity is needed.
Dakle, unatoč razlikama u prevalenciji genotipa CYP3A5 u pojedinima rasama, učinak genotipa CYP3A5 na izloženost maraviroku ne smatra se klinički značajnim, pa nije potrebno prilagođavati dozu maraviroka na temelju genotipa CYP3A5, rase ni etničkog podrijetla.
Available toxicological data in animals has shown extensive excretion of maraviroc in milk.
Dostupni toksikološki podaci prikupljeni u životinja pokazali su visok stupanj lučenja maraviroka u mlijeko.
Population analysis of the Phase 1/2a and Phase 3 studies (16-65 years of age) has been conducted and no effect of age have been observed (see section 4.2).
Populacijska analiza provedena u studijama faze 1/2a i faze 3 (16-65 godina starosti) nije pokazala postojanje utjecaja dobi (vidjeti dio 4.2).
Delayed type hypersensitivity reactions, typically occurring within 2-6 weeks after start of therapy and including rash, fever, eosinophilia and liver reactions have been reported (see also section 4.4).
Prijavljene su reakcije preosjetljivosti kasnog tipa, koje su obično nastupile unutar 2 - 6 tjedana nakon početka liječenja, a uključivale su osip, vrućicu, eozinofiliju i jetrene reakcije (vidjeti i dio 4.4).
The effects of moderate hepatic impairment may be underestimated due to limited data in patients with decreased metabolic capacity and higher renal clearance in these subjects.
Učinci umjerenog oštećenja jetre moguće su podcijenjeni zbog nedostatnih podataka u bolesnika sa smanjenim metaboličkim kapacitetom i povećanim bubrežnim klirensom kod tih bolesnika.
The serum adjusted EC90 value in 43 primary HIV-1 clinical isolates was 0.57 (0.06 - 10.7) ng/mL without significant changes between different subtypes tested.
Korigirana serumska vrijednost EC90 kod 43 primarna HIV-1 klinička izolata iznosila je 0,57 (0,06 - 10,7) ng/ml, bez značajnih promjena među različitim testiranim podtipovima.
CELSENTRI can make you dizzy.
CELSENTRI može uzrokovati omaglicu.
Genotypic resistance
Genotipska rezistencija
One additional subject had CCR5 tropic-virus with reduced susceptibility to maraviroc at virologic failure, although this was not retained at the end of treatment.
Jedan dodatni ispitanik imao je CCR5-tropni virus smanjene osjetljivosti na maravirok kod virološkog neuspjeha, ali se to nije zadržalo do kraja liječenja.
In rabbit, 7 foetuses had external anomalies at maternally toxic doses and 1 foetus at the mid dose of 75 mg/kg.
Kod kunića je 7 fetusa imalo vanjske anomalije pri dozama toksičnim za majku, a kod jednog fetusa i pri primjeni srednje doze od 75 mg/kg.
Doses were given with food on intensive pharmacokinetic evaluation days and optimised to achieve an average concentration over the dosing interval (Cavg) of greater than 100 ng/mL; otherwise, maraviroc was given with or without food.
Onih dana kada se provodilo intenzivno ocjenjivanje farmakokinetike, doze su se primjenjivale s hranom te su se optimizirale radi postizanja prosječne koncentracije tijekom intervala doziranja (Cavg) veće od 100 ng/ml; inače se maravirok primjenjivao s hranom ili bez nje.
Population PK studies suggest that a dose adjustment of maraviroc is not required.
Populacijska farmakokinetička ispitivanja ukazuju da nije potrebno prilagođavanje doze maraviroka.
 problems with your heart or circulatory system.
• tegobe sa srcem ili cirkulacijom.
Patients should be informed that dizziness has been reported during treatment with maraviroc.
Bolesnike treba obavijestiti da je tijekom liječenja maravirokom prijavljena omaglica.
Special patient populations:
Posebne populacije bolesnika:
Mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
Uočeno je da se mutacije nakupljaju u glikoproteinu ovojnice gp120 (virusni protein koji se veže na za CCR5 koreceptor).
• an increase in a substance known as CPK (seen in blood test results) which is a sign that muscles are inflamed or damaged.
• povišena razina tvari koja se zove CPK (vidljivo u nalazima krvnih pretraga), koja je znak upale ili oštećenja mišića
HERBAL PRODUCTS St. John's Wort (Hypericum Perforatum)
BILJNI PRIPRAVCI Gospina trava (Hypericum perforatum)
Primary pharmacological activity (CCR5 receptor affinity) was limited in the species studied (see section 5.3).
Osnovni farmakološki učinak (afinitet za CCR5 receptore) kod ispitivanih vrsta bio je ograničen (vidjeti dio 5.3).
The pack includes an oral applicator and a bottle-adapter, which should be fitted in the bottle before use.
Pakiranje uključuje aplikator za usta i nastavak koji treba utisnuti u grlo boce prije prve uporabe.
Clarithromycin, Telithromycin
Klaritromicin, telitromicin
Limit
Granice
Caution should be used when administering maraviroc in patients on concomitant medicinal products known to lower blood pressure.
Potreban je oprez kada se maravirok primjenjuje u bolesnika koji istodobno primaju lijekove za koje se zna da snizuju krvni tlak.
Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
Maravirok se selektivno veže na ljudski kemokinski receptor CCR5, sprječavajući pritom ulazak CCR5-tropnog HIV-1 u stanice.
Limited data are available in adult patients with hepatic impairment and no data are available to recommend a specific dose for paediatric patients.
Podaci o primjeni lijeka u odraslih bolesnika s oštećenom jetrom su ograničeni i nema dostupnih podataka na temelju kojih bi se preporučila specifična doza za pedijatrijske bolesnike.
Alanine aminotransferase increased, aspartate aminotransferase increased common
Porast alanin aminotransferaze, porast aspartat aminotransferaze često
An analysis of tropism following failure of maraviroc therapy with CXCR4using virus in patients with CCR5 virus at baseline, demonstrated that the virus population reverted back to CCR5 tropism in 33 of 36 patients with more than 35 days of follow-up.
Analiza tropizma nakon neuspjeha terapije maravirokom, s prisutnim virusom koji koristi CXCR4 kod bolesnika s CCR5 virusom na početku liječenja, pokazala je da se populacija virusa vratila ponovno na CCR5-tropizam u 33 od 36 bolesnika tijekom perioda praćenja od 35 dana.
Maraviroc belongs to a group of medicines called CCR5 antagonists.
Maravirok pripada skupini lijekova koji se nazivaju antagonistima CCR5.
Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine.
Budući da se maravirok umjereno veže na proteine plazme, dijaliza može biti korisna u njegovom odstranjivanju.
Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Film ovojnica: poli(vinilni alkohol), titanijev dioksid (E171), makrogol 3350, talk, sojin lecitin, bojilo "indigo carmine aluminium lake“ (E132).
In the Week 48 analysis (N=103), non-CCR5 tropic-virus was detected in 5/23 (22%) subjects at virologic failure.
U analizi provedenoj u 48. tjednu (N=103) virus koji nije CCR5-tropan izoliran je kod virološkog neuspjeha u 5/23 (22%) ispitanika.
Clinical status and relevant blood chemistry should be monitored and appropriate symptomatic therapy initiated.
Potrebno je nadzirati klinički status i relevantne biokemijske parametre te uvesti odgovarajuće simptomatsko liječenje.
The pharmacokinetics of maraviroc in paediatric patients below 2 years of age have not been established (see section 4.2).
Nije utvrđena farmakokinetika maraviroka kod pedijatrijskih bolesnika mlađih od 2 godine (vidjeti dio 4.2).
Thus, CELSENTRI dose should be modified in line with the recommendation for co-administration with respective PI/ritonavir combination (see ‘Protease Inhibitors').
Stoga dozu lijeka CELSENTRI treba prilagoditi sukladno preporukama za istodobnu primjenu s odgovarajućom kombinacijom inhibitora proteaze/ritonavira (vidjeti 'inhibitori proteaze').
Studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system to metabolites that are essentially inactive against HIV-1.
Ispitivanja u ljudi kao i in vitro ispitivanja na humanim mikrosomima jetre i pojedinim enzimskim sustavima pokazala su da se maravirok pretežno metabolizira putem sustava citokroma P450 u metabolite koji su u osnovi inaktivni prema HIV-1.
70 subjects (Child-Pugh Class A, n=64; Child-Pugh Class B, n=6) were randomized to the maraviroc group and 67 subjects (Child-Pugh Class A, n=59; Child-Pugh Class B, n=8) were randomized to the placebo group.
Sedamdeset ispitanika (Child-Pugh stadij A, n=64; Child-Pugh stadij B, n=6) bilo je randomizirano u skupinu koja je primala maravirok i 67 ispitanika (Child-Pugh stadij A, n=59; Child-Pugh stadij B, n=8) u skupinu koja je primala placebo.
The impact of potent CYP3A inhibitors and/or inducers on maraviroc pharmacokinetic parameters in paediatric patients was similar to that observed in adults.
Utjecaj snažnih inhibitora i/ili induktora CYP3A na farmakokinetičke parametre maraviroka u pedijatrijskih bolesnika bio je sličan onome opaženom u odraslih.
All subjects in the Phase 1 study achieved the Cavg concentrations that have been shown to be associated with near maximal virologic efficacy with maraviroc (75 ng/mL) in the Phase 3 study in treatment-naïve adult patients (MERIT).
Svi ispitanici u ispitivanju faze 1 postigli su koncentracije Cavg koje su bile povezane s gotovo maksimalnom virološkom djelotvornošću kod primjene maraviroka (75 ng/ml) u ispitivanju faze 3 provedenom u prethodno neliječenih odraslih bolesnika (MERIT).
1Based on GeneSeq resistance assay.
1 Na temelju testa za određivanje rezistencije GeneSeq
CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.
CELSENTRI filmom obložene tablete su plave s oznakom „MVC 25“, „MVC 75“, „MVC 150“ ili „MVC 300“.
Concomitant Medications
Istodobno primijenjeni lijekovi
Tell your doctor if you (or your child) are taking any of these medicines.
Recite svom liječniku ako Vi (ili Vaše dijete) uzimate neki od navedenih lijekova.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
U svakoj frekvencijskoj skupini nuspojave su prikazane redoslijedom od najozbiljnijih prema manje ozbiljnim.
• 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 ).
• ako ste Vi (ili Vaše dijete, ako je ono bolesno) alergični na maravirok, kikiriki, soju ili neki drugi sastojak lijeka CELSENTRI (naveden u dijelu 6.).
Clinical results
Rezultati kliničkih ispitivanja
These reactions included rash, fever, and sometimes organ dysfunction and hepatic failure.
Navedene reakcije uključivale su osip, vrućicu te ponekad disfunkciju organa i zatajenje jetre.
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Njemačka.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Prijavljeni su slučajevi osteonekroze, posebice kod bolesnika s opće poznatim čimbenicima rizika, uznapredovalom HIV bolešću ili dugotrajnoj izloženosti kombiniranoj antiretrovirusnoj terapiji.
Any inflammatory symptoms should be evaluated and treatment initiated when necessary.
Svaki simptom upale treba dobro procijeniti i u slučaju potrebe započeti liječenje.
The latter group had markers correlating to low compliance (low and variable drug levels and often a calculated high residual sensitivity score of the OBT).
Ova skupina bolesnika imala je markere koji ukazuju na lošu suradljivost (niske i varijabilne razine lijeka te često izračunati visoki rezultat rezidualne osjetljivosti OBT).
The pharmacokinetics of maraviroc is dependent on CYP3A5 activity and expression level, which can be modulated by genetic variation.
Farmakokinetika maraviroka ovisi o aktivnosti i razini ekspresije CYP3A5, na koje mogu utjecati genske varijacije.
Refer to the Package Leaflets of these other medicines for guidance on how to take them.
Pročitajte upute o drugim lijekovima da biste znali kako ih uzimati.
Immune reconstitution syndrome
Sindrom ponovnog uspostavljanja imunosti
Maraviroc was evaluated for carcinogenic potential by a 6 month transgenic mouse study and a 24 month study in rats.
Karcinogenost maraviroka ispitivana je na transgeničnim miševima tijekom 6 mjeseci i na štakorima kroz 24 mjeseca.
The dose limiting adverse reaction was postural hypotension.
Nuspojava koja je ograničavala dozu bila je posturalna hipotenzija.
Benzodiazepines
Benzodiazepini
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.
Medijan vršne koncentracije maraviroka u plazmi postiže se za dva sata (raspon 0,5-4 sata) nakon jednokratne primjene komercijalne tablete od 300 mg zdravim dobrovoljcima.
However, a significant treatment benefit for maraviroc compared to placebo + OBT was still demonstrated (see Table 7).
Usprkos tome, prikazana je značajna korist od liječenja maravirokom u odnosu na liječenje kombinacijom placebo + OBT (vidjeti Tablicu 7.).
In vitro and in vivo studies showed that maraviroc has a potential to increase QTc interval at supratherapeutic doses with no evidence of arrhythmia.
In vitro i in vivo ispitivanja pokazala su da maravirok ima sposobnost produženja QTc intervala u dozama višim od terapijskih, bez podataka o nastanku aritmije.
It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.
Ne može se isključiti mogućnost da maravirok može povećati izloženost dabigatran eteksilatu, supstratu za P-glikoprotein.
In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2).
Ispitivanja in vitro pokazala su da maravirok u klinički relevantnim koncentracijama ne inhibira nijedan od glavnih prijenosnika za unos tvari u bubrezima (OAT1, OAT3, OCT2, OCTN1 i OCTN2).
• increase in liver enzymes (seen in blood test results), which can be a sign of liver problems (see also ‘Liver problems' earlier in section 4).
• povišenje vrijednosti jetrenih enzima (vidljivo u nalazima krvnih pretraga), koje može biti znak jetrenih tegoba (pogledajte i dio 'Jetrene tegobe' prethodno u dijelu 4.).
There are limited data in patients with hepatitis B and/or C virus co-infection (see section 5.1).
Ograničeni su podaci u bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili hepatitisa C (vidjeti dio 5.1).
Studies in Adult Patients Co-infected with Hepatitis B and/or Hepatitis C virus
Ispitivanja u odraslih bolesnika koji su istodobno zaraženi virusom hepatitisa B i/ili hepatitisa C
The pack contains an oral applicator and a bottle adapter.
Pakiranje sadrži aplikator za usta i nastavak za bocu.
If a child is unable to reliably swallow CELSENTRI tablets, the oral solution (20 mg per mL) should be prescribed (refer to Summary of Product Characteristics for CELSENTRI oral solution).
Ako nije sigurno da dijete može progutati CELSENTRI tablete, treba propisati oralnu otopinu (20 mg/ml) (vidjeti Sažetak opisa svojstava lijeka za CELSENTRI oralnu otopinu).
Blood and lymphatic system disorders Absolute neutrophil count
Poremećaji krvi i limfnog sustava Apsolutni broj neutrofila
Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Hepatobilijarni poremećaji zabilježeni u prethodno neliječenih bolesnika bili su rijetki i podjednako raspoređeni u svim liječenim skupinama (vidjeti dio 4.8).
Fewer patients discontinued maraviroc due to adverse events (15 vs. 49).
Manje je bolesnika koji su prekinuli uzimati maravirok zbog nuspojava (15 prema 49).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, can have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Kod bolesnika s od ranije postojećim oštećenjem funkcije jetre, uključujući kronični aktivni hepatitis, primijećena je povećana učestalost poremećaja jetrene funkcije tijekom primjene kombinirane antiretrovirusne terapije i stoga ih je potrebno nadzirati sukladno standardnoj medicinskoj praksi.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Prijavljeni su i autoimuni poremećaji (kao što je Gravesova bolest i autoimuni hepatitis); međutim, prijavljeno vrijeme do nastupa bolesti je varijabilnije pa se ti događaji mogu javiti i mjesecima nakon započinjanja liječenja (vidjeti dio 4.4).
Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc.
Osim toga, istodobna primjena maraviroka s tenofovirom (izlučuje se bubrezima) i kotrimoksazolom (sadrži trimetoprim, inhibitor transporta kationa u bubrezima) nije dovela do promjene farmakokinetike maraviroka.
The gp120 amino acid substitutions identified so far are context dependent and inherently unpredictable with regards to maraviroc susceptibility.
Dosad utvrđene aminokiselinske supstitucije gp120 ovise o kontekstu te je njihova povezanost s osjetljivošću na maravirok inherentno nepredvidljiva.
• The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, strawberry flavouring (501440T), purified water
• Drugi sastojci su: citratna kiselina (bezvodna), natrijev citrat dihidrat, sukraloza, natrijev benzoat, aroma jagode (501440T), pročišćena voda Kako CELSENTRI izgleda i sadržaj pakiranja
The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Simptomi autoimunih poremećaja mogu se razviti mjesecima nakon početka uzimanja lijeka za liječenje HIV-a, a mogu uključivati:
Adult dosage*
Doza za odrasle*
Insert the applicator (C) firmly into the adapter.
3. Umetnite aplikator (C) čvrsto u nastavak za bocu.
Overall, the mechanisms of resistance to maraviroc observed in this treatment-experienced paediatric population were similar to those observed in adult populations.
Sveukupno je mehanizam rezistencije na maravirok opažen u toj prethodno liječenoj pedijatrijskoj populaciji bio sličan onome primijećenom u odraslim populacijama.
Significant reductions in amprenavir Cmin observed may result in virological failure in patients
Uočena značajna smanjenja Cmin amprenavira kod bolesnika mogu dovesti do neuspješnog virološkog djelovanja.
230 ml oral solution
230 ml oralne otopine
Baseline CD4+ (cells/µL):
Početni broj CD4+ (stanice/µl):
The solution is colourless with strawberry flavouring.
Otopina je bezbojna i ima okus jagode.
Clear, colourless, oral solution.
Bistra i bezbojna oralna otopina.
In patients with CCR5-tropic virus at time of treatment failure with maraviroc, 22 out of 58 patients had virus with reduced sensitivity to maraviroc.
Kod bolesnika kod kojih je u trenutku izostanka učinka maraviroka izoliran CCR5-tropni virus, njih 22 od 58 imalo je virus slabije osjetljiv na maravirok.