natgillin/translations-raw huggingface dataset:
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.
Med bolniki, ki so imeli ob neuspehu zdravljenja z maravirokom CCR5-tropni virus, je imelo 22 od 58 bolnikov virus z zmanjšano občutljivostjo za maravirok.
No clinically significant interaction seen.
Ni klinično pomembnih medsebojnih učinkov.
Table 5: Demographic and baseline characteristics of patients (pooled studies MOTIVATE 1 and MOTIVATE 2)
Preglednica 5: Demografske in izhodiščne značilnosti bolnikov (kumulativno za študiji MOTIVATE 1 in MOTIVATE 2)
Maraviroc is a substrate for the transporters P-glycoprotein and OATP1B1, but the effect of these transporters on the exposure to maraviroc is not known.
Maravirok je substrat prenašalcev P-glikoproteina in OATP1B1, vendar učinek teh prenašalcev na izpostavljenost maraviroku ni znan.
If you have a kidney problem, your doctor may alter your dose.
Osebe, ki imajo težave z ledvicami Če imate težave z ledvicami, vam lahko zdravnik spremeni odmerek.
A mass balance/excretion study was conducted using a single 300 mg dose of 14C-labeled maraviroc.
Študija masnega ravnovesja/izločanja je bila narejena z uporabo posamičnega 300 mg odmerka maraviroka, označenega s 14C.
Limited data exist with the use of maraviroc in patients with severe cardiovascular disease, therefore special caution should be exercised when treating these patients with maraviroc.
O uporabi maraviroka pri bolnikih s hudimi srčnožilnimi boleznimi so na voljo le omejeni podatki, zato je pri zdravljenju teh bolnikov z maravirokom potrebna posebna previdnost.
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.
Dodatno, sočasna uporaba maraviroka s tenofovirjem (substrat za ledvično izločanje) in kotrimoksazolom (vsebuje trimetoprim, zaviralec ledvičnega transporta kationov) ni vplivala na farmakokinetiko maraviroka.
Limited data are available in adult patients with hepatic impairment and no data are available to recommend a specific dose for paediatric patients.
Podatkov pri odraslih bolnikih z okvaro jeter je malo in podatkov, ki bi omogočili priporočilo specifičnega odmerka za pediatrične bolnike, ni.
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090
Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Nemčija
The impact of potent CYP3A inhibitors and/or inducers on maraviroc pharmacokinetic parameters in paediatric patients was similar to that observed in adults.
Vpliv močnih zaviralcev in/ali induktorjev CYP3A na farmakokinetične parametre maraviroka je bil pri pediatričnih bolnikih podoben kot pri odraslih.
Before taking this medicine, make sure that your doctor knows if you (or your child) have or in the past had any of the following:
Preden začnete uporabljati to zdravilo, morate zdravniku povedati, če imate vi (ali vaš otrok) ali ste v preteklosti imeli kaj od naštetega:
The pack also includes a thermoplastic elastomeric press in bottle adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with mL graduations) and a polyethylene plunger.
Pakiranje vsebuje tudi termoplastični elastomerni vtisni nastavek za plastenko in 10 ml aplikator za peroralno odmerjanje, sestavljeno iz polipropilenskega valja (z mililitrsko graduacijo) in polietilenskega bata.
There are limited data from the use of maraviroc in pregnant women.
Podatkov o uporabi maraviroka pri nosečnicah je malo.
After 48 weeks of treatment, maraviroc did not reach non-inferiority to efavirenz for the endpoint of HIV-1 RNA < 50 copies/mL (65.3 vs. 69.3 % respectively, lower confidence bound -11.9%).
Po 48-tedenskem zdravljenju maravirok ni dosegel neinferiornosti glede na efavirenz pri končni točki HIV-1 RNA < 50 kopij/ml (65,3 proti 69,3 % za posamezno zdravilo, spodnja meja zaupanja -11,9 %).
Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥1 NRTIs, ≥1 NNRTIs, ≥2 PIs, and/or enfurvirtide] or documented resistance to at least one member of each class.
Bolniki, ki so bili primerni za ti študiji, so bili predhodno izpostavljeni vsaj 3 skupinam protiretrovirusnih zdravil [≥ 1 nukleozidnim zaviralcem reverzne transkriptaze, ≥ 1 nenukleozidnim zaviralcem reverzne transkriptaze, ≥ 2 zaviralcem proteaz in/ali enfurvirtidu] ali so imeli dokumentirano odpornost proti vsaj enemu pripadniku vsake od teh skupin.
In rats, there were no adverse effects on male or female fertility (see section 5.3).
Pri podganah ni bilo neželenih učinkov na plodnost pri samcih ali samicah (glejte poglavje 5.3).
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 po neuspehu terapije z maravirokom ob virusu uporabniku CXCR4 pri bolnikih s CCR5 virusom v izhodišču, je pokazala, da se je med več kot 35 dnevnim spremljanjem populacija virusov povrnila v CCR5-tropizem pri 33 od 36 bolnikov.
There may be a risk of suboptimal levels with risk of loss of virologic response and resistance development.
Obstaja lahko tveganje za suboptimalno koncentracijo z izgubo virološkega odziva in pojavom odpornosti.
Symptoms of infection and inflammation
Simptomi okužbe ali vnetja
The oral applicator is provided for accurate measurement of the prescribed dose of oral solution.
Aplikator za peroralno odmerjanje je dodan za točno odmerjanje predpisanega odmerka peroralne raztopine.
A slight increase in motor activity in high-dose male rats at both weaning and as adults was noted, while no effects were seen in females.
Opazili so rahlo povečanje motorične aktivnosti pri podganjih samcih, ki so dobivali velike odmerke, tako pri odstavljanju kot pri odraslih; učinkov pri samicah ni bilo.
The pharmacokinetics of maraviroc in paediatric patients below 2 years of age have not been established (see section 4.2).
Farmakokinetika maraviroka pri pediatričnih bolnikih, mlajših od 2 let, ni ugotovljena (glejte poglavje 4.2).
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).
Študije in vitro so pokazale, da maravirok v klinično pomembnih koncentracijah ne zavira nobenega od pomembnih prenašalcev ledvičnega privzema (OAT1, OAT3, OCT2, OCTN1 in OCTN2).
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.
Zato vpliv genotipa CYP3A5 na izpostavljenost maraviroku kljub razlikam v prevalenci CYP3A5 med rasami ne velja za klinično pomembnega in odmerka maraviroka ni treba prilagajati glede na genotip CYP3A5, raso ali etnično pripadnost.
The CYP3A5 allelic frequency depends on ethnicity: the majority of Caucasians (~90%) are poor metabolisers of CYP3A5 substrates (i.e., subjects with no copy of functional CYP3A5 alleles) while approximately 40% of African-Americans and 70% of Sub-Saharan Africans are extensive metabolisers (i.e., subjects with two copies of functional CYP3A5 alleles).
Alelska pogostnost CYP3A5 je odvisna od etnične pripadnosti: večina belcev (~90 %) je slabih metabolizatorjev substratov CYP3A5 (tj. nimajo nobene kopije funkcionalnih alelov CYP3A5), medtem ko je približno 40 % Afroameričanov in 70 % podsaharskih Afričanov izrazitih metabolizatorjev (tj. imajo dve kopiji funkcionalnih alelov CYP3A5).
Caution should be used when administering maraviroc in patients on concomitant medicinal products known to lower blood pressure.
Previdnost je potrebna v primeru uporabe maraviroka pri bolnikih, sočasno zdravljenih s kakšnim zdravilom, ki znižuje krvni tlak.
There are currently no data regarding the reuse of CELSENTRI in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on CELSENTRI (or other CCR5 antagonists) with a CXCR4 or dual/mixed tropic virus.
Za zdaj ni podatkov o ponovni uporabi zdravila CELSENTRI pri bolnikih, pri katerih je trenutno ugotovljiv samo CCR5-tropni HIV-1, imajo pa anamnezo o neuspehu zdravljenja z zdravilom CELSENTRI (ali drugimi antagonisti CCR5) s CXCR4- ali dualno/mešano-tropnim virusom.
Further details for concomitantly administered medicinal products are provided below (see Table
Dodatne podrobnosti o sočasni uporabi zdravil so navedene spodaj (glejte preglednico 2).
These reactions included rash, fever, and sometimes organ dysfunction and hepatic failure.
Med temi reakcijami so bile izpuščaj, zvišana telesna temperatura ter včasih moteno delovanje organov in odpoved jeter.
The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time.
Priporočeni odmerek zdravila CELSENTRI je 150 mg, 300 mg ali 600 mg dvakrat na dan, odvisno od drugih zdravil, ki jih jemljete sočasno.
CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.
Filmsko obložene tablete CELSENTRI so modre barve, z oznako “MVC 25”, “MVC 75”, “MVC 150” ali “MVC 300”.
There are no data available to recommend a specific dose in paediatric patients with renal impairment.
Podatkov, ki bi omogočili priporočilo specifičnega odmerka pri pediatričnih bolnikih z okvaro ledvic, ni.
A relatively small number of individuals receiving maraviroc-containing therapy have failed with phenotypic resistance (i.e. the ability to use drug-bound CCR5 with MPI <95%).
Pri razmeroma majhnem številu oseb, katerih zdravljenje je vključevalo maravirok, se je pojavil neuspeh s fenotipsko odpornostjo (tj. zmožnost uporabe CCR5 z vezanim zdravilom z MPI < 95 %).
• rash (see also ‘Serious allergic or skin reactions' earlier in section 4)
• izpuščaj (glejte tudi "Resne alergijske ali kožne reakcije", zgoraj v poglavju 4),
Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the maximum recommended dose of 300 mg twice daily.
Podaljšanje intervala QT so pri psih oz. opicah opažali ob koncentracijah v plazmi, ki so bile 6-krat oz. 12-krat tolikšne, kot so pričakovane pri ljudeh ob uporabi največjega priporočenega odmerka 300 mg dvakrat na dan.
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Pomembni primeri so citomegalovirusni retinitis, generalizirane in/ali fokalne okužbe z mikobakterijami in pljučnica s Pneumocystis jiroveci (včasih imenovana Pneumocystis carinii).
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).
Vsi preiskovanci v študiji faze I so dosegli koncentracijo Cavg, ki je dokazano povezana s skoraj maksimalno virološko učinkovitostjo z maravirokom (75 ng/mL) v študiji 3. faze pri predhodno še nezdravljenih odraslih bolnikih (MERIT).
Remove and wash the applicator thoroughly in clean water once you have finished using it. Let it dry completely before you use it again.
Pustite, naj se popolnoma posuši, preden ga ponovno uporabite.
Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
Selektivno se veže na humani kemokinski receptor CCR5 in tako CCR5-tropnemu HIV-1 prepreči vstop v celice.
After intravenous administration (30 mg), the half-life of maraviroc was 13.2 h, 22% of the dose was excreted unchanged in the urine and the values of total clearance and renal clearance were 44.0 L/h and 10.17 L/h respectively.
Po intravenski aplikaciji (30 mg) je bila razpolovna doba maraviroka 13,2 uri, 22 % odmerka se je v nespremenjeni obliki izločilo v urinu in vrednosti celotnega očistka ter ledvičnega očistka so bile 44,0 l/h ter 10,17 l/h.
Tell your doctor if you (or your child) are taking any of these medicines.
Zdravniku morate povedati, če vi (ali vaš otrok) jemljete katero od teh zdravil.
Fewer patients discontinued maraviroc due to adverse events (15 vs. 49).
Manj bolnikov je prekinilo zdravljenje z maravirokom zaradi neželenih učinkov (15 proti 49).
Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM).
Maravirok in vitro zavira P-glikoprotein (IC50 je 183 µM).
Efavirenz and atazanavir/ritonavir or darunavir/ritonavir
Efavirenz in atazanavir/ritonavir ali darunavir/ritonavir
1Based on GeneSeq resistance assay.
1 Na podlagi testa odpornosti GeneSeq.
• The active ingredient in CELSENTRI is maraviroc.
• Učinkovina v zdravilu CELSENTRI je maravirok.
Subjects with a functional CYP3A5 (CYP3A5*1 allele) have been shown to have a reduced exposure to maraviroc compared to subjects with defect CYP3A5 activity (e.g., CYP3A5*3, CYP3A5*6, and CYP3A5*7).
Ugotovljeno je, da imajo osebe s funkcionalnim CYP3A5 (alelom CYP3A5*1) manjšo izpostavljenost maraviroku kot osebe s pomanjkljivo aktivnostjo CYP3A5 (npr. CYP3A5*3, CYP3A5*6 in CYP3A5*7).
Maraviroc dosing was based on body surface area and doses were adjusted based on whether the subject was receiving potent CYP3A inhibitors and/or inducers.
Odmerjanje maraviroka je temeljilo na telesni površini, odmerki pa so bili prilagojeni glede na to, ali je preiskovanec prejemal močne zaviralce in/ali induktorje CYP3A.
There is limited experience in patients with reduced hepatic function, therefore maraviroc should be used with caution in this population (see sections 4.2 and 5.2).
Izkušnje pri bolnikih z zmanjšanim delovanjem jeter so omejene, zato je treba maravirok v tej populaciji uporabljati previdno (glejte poglavji 4.2 in 5.2).
Cross-resistance in vitro
Navzkrižna odpornost in vitro
Limited numbers of patients from ethnicities other than Caucasian were included in the pivotal clinical studies, therefore very limited data are available in these patient populations.
V obe ključni klinični študiji je bilo vključenih le malo bolnikov iz drugih etničnih skupin razen belcev, zato je podatkov za te populacije bolnikov zelo malo.
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.
Pri bolnikih z obstoječo disfunkcijo jeter, vključno s kroničnim aktivnim hepatitisom, se lahko med kombinirano protiretrovirusno terapijo pogosteje pojavijo nepravilnosti delovanja jeter, zato morate takšne bolnike nadzorovati skladno z običajno prakso.
CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults, adolescents and children of 2 years and older, and weighing at least 10 kg.
Zdravilo CELSENTRI se uporablja za zdravljenje okužb z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) pri odraslih, mladostnikih in otrocih, starih 2 leti ali več in s telesno maso vsaj 10 kg.
Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Študija A4001029 je bila eksplorativna študija pri bolnikih, okuženih z dualno/mešano-tropnim ali CXCR4-tropnim HIV-1; načrt študije je bil podoben kot načrt študij MOTIVATE 1 in MOTIVATE 2.
The pharmacokinetics in other races has not been evaluated.
Farmakokinetike niso preiskovali pri drugih rasah.
There are limited data in patients with hepatitis B and/or C virus co-infection (see section 5.1).
O bolnikih sočasno okuženih z virusom hepatitisa B in/ali hepatitisa C je malo podatkov (glejte poglavje 5.1).
The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied.
Vpliv maraviroka na digoksin v odmerku 600 mg 2-krat na dan ni raziskan.
 problems with your heart or circulatory system.
• težave s srcem ali obtočili.
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.
Dolgoročna varnost/opazovani dogodki (LTS/SE - The Long Term safety/Selected Endpoints) so vključevali smrtne izide, dogodke značilne za AIDS, odpoved jeter, miokardni infarkt/srčno ishemijo, maligne bolezni, rabdomializo in druge hude okužbe pri uporabi maraviroka.
Population PK analysis in phase 3 studies suggests dose reduction of maraviroc when co-administered with indinavir gives appropriate maraviroc exposure.
Analiza populacijske farmakokinetike v študijah 3. faze kaže, da zmanjšanje odmerka maraviroka med sočasno uporabo z indinavirjem omogoči ustrezno izpostavljenost maraviroku.
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).
Poročali so o pozni obliki preobčutljivostnih reakcij, ki so se praviloma pojavile v 2-6 tednih po začetku zdravljenja in so obsegale izpuščaj, zvišano telesno temperaturo, eozinofilijo in jetrne reakcije (glejte tudi poglavje 4.4).
Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors.
Na račun ledvičnega očistka gre približno 23 % celotnega očistka maraviroka, kadar je le-ta uporabljen brez zaviralcev CYP3A4.
Metabolism and nutrition disorders Anorexia common
Presnovne in prehranske motnje anoreksija pogosti
Significant reductions in amprenavir Cmin observed may result in virological failure in patients
Opaženo bistveno zmanjšanje Cmin amprenavirja lahko pri bolnikih povzroči virološki neodziv.
If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
However, a significant treatment benefit for maraviroc compared to placebo + OBT was still demonstrated (see Table 7).
Kljub temu je bila dokazana bistvena terapevtska korist zdravila CELSENTRI v primerjavi s placebom + OOT (glejte preglednico 7).
In patients failing therapy with CCR5-tropic virus only, maraviroc might be considered still active if the MPI value is ≥95% (PhenoSense Entry assay).
Pri neuspešno zdravljenih bolnikih, ki so imeli samo CCR5-tropni virus, lahko maravirok smatramo kot še vedno učinkovit, če je MPI ≥95% (meritev z metodo PhenoSense Entry).
Tropism
Tropizem
Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low.
Na podlagi podatkov in vitro in kliničnih podatkov ima maravirok majhen potencial za vpliv na farmakokinetiko sočasno uporabljenih zdravil.
Maraviroc is primarily metabolized and eliminated by the liver.
Maravirok se presnovi in eliminira predvsem v jetrih.
Repeated dose toxicity studies in rats identified the liver as the primary target organ for toxicity (increases in transaminases, bile duct hyperplasia, and necrosis).
Študije toksičnosti pri ponavljajočih se odmerkih pri podganah so pokazale, da so jetra primarni tarčni organ za toksičnost (zvišanje transaminaz, hiperplazija žolčevodov in nekroza).
Overall, the mechanisms of resistance to maraviroc observed in this treatment-experienced paediatric population were similar to those observed in adult populations.
V celoti so bili mehanizmi odpornosti proti maraviroku v tej, predhodno že zdravljeni pediatrični populaciji podobni kot so jih opažali pri odraslih.
• diarrhoea, feeling sick, stomach ache, wind (flatulence),
• driska, občutek slabosti, bolečine v želodcu, vetrovi (flatulenca),
The recommended dose of CELSENTRI is either 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg (30 ml) twice daily, depending on other medicines that you are taking at the same time.
Priporočeni odmerek zdravila CELSENTRI je ali 150 mg (7,5 ml), 300 mg (15 ml) ali 600 mg (30 ml) dvakrat na dan, odvisno od drugih zdravil, ki jih jemljete sočasno.
Failure with CXCR4-using virus
Neuspeh z virusom uporabnikom CXCR4
Subjects were required to have HIV-1 RNA greater than 1,000 copies per mL at Screening.
Preiskovanci so morali imeti ob presejanju HIV-1 RNA več kot 1.000 kopij/ml.
Baseline CD4+ (cells/µL):
Izhodiščno število CD4+ (celic/µl):
Patients were randomised in a 2:2:1 ratio to maraviroc 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir).
Bolniki so bili v razmerju 2:2:1 randomizirani na maravirok 300 mg (enakovrednost odmerka) enkrat na dan, dvakrat na dan ali placebo v kombinaciji z optimizirano osnovno terapijo (OOT), ki je obsegala od 3 do 6 protiretrovirusnih zdravil (izključujoč nizkoodmerni ritonavir).
The pack includes an oral applicator and a bottle-adapter, which should be fitted in the bottle before use.
Pakiranju je priložen aplikator za peroralno odmerjanje in nastavek za plastenko, ki ga je treba pred uporabo namestiti v plastenko.
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 ni neugodno vplival na parjenje in plodnost podganjih samcev in samic ter pri samcih v odmerkih do 1000 mg/kg ni prizadel semena.
However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo.
Vendar pa maravirok in vivo ne vpliva pomembno na farmakokinetiko digoksina.
In addition, cholangiocarcinomas (2/60 males at 900 mg/kg) and cholangioma (1/60 females at 500 mg/kg) were reported in the rat study at a systemic exposure at least 15-times the expected free human exposure.
Dodatno so v študiji pri podganah poročali o holangiokarcinomih (2/60 samcev pri 900 mg/kg) ter holangioadenomih (1/60 samic pri 500 mg/kg,) in sicer pri sistemski izpostavljenosti, ki je bila vsaj 15-krat tolikšna kot pričakovana prosta izpostavljenost pri človeku.
Therefore, maraviroc tablets and oral solution can be taken with or without food at the recommended doses in adults, adolescents and children aged 2 years and older and weighing at least 10 kg (see section 4.2).
Zato je mogoče tablete in peroralno raztopino maraviroka v priporočenih odmerkih jemati s hrano ali brez nje; to velja za odrasle, mladostnike in otroke, stare 2 leti ali več in s telesno maso vsaj 10 kg (glejte poglavje 4.2).
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.
Dodaten preiskovanec je imel ob virološkem neodzivu CCR5-tropni virus z zmanjšano občutljivostjo za maravirok, ki pa se ni ohranil do konca zdravljenja.
Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc (<100% maximal percentage inhibition (MPI)).
Krivulje odziva na koncentracijo za viruse, odporne proti maraviroku, so bile fenotipsko določene s krivuljami, ki v preskusih z zaporednimi razredčenji maraviroka niso dosegle 100 % zavrtja (<100% maksimalni delež zaviranja (MPI)).
Maraviroc should also be used with caution in patients with severe renal insufficiency and in patients who have risk factors for, or have a history of postural hypotension.
Maravirok je treba previdno uporabljati tudi pri bolnikih s hudo insuficeno ledvic in tistih z dejavniki tveganja za posturalno hipotenzijo ali z njeno anamnezo.
There were no food restrictions in the adult studies (using tablet formulations) or in the paediatric study (using both tablet and oral solution formulations).
Ne v študijah pri odraslih (z uporabo tablet) ne v študijah pri pediatričnih bolnikih (z uporabo tablet in peroralne raztopine) ni bilo prehranskih omejitev.