natgillin/translations-raw huggingface dataset:
CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets
CELSENTRI 25 mg filmsko obložene tablete CELSENTRI 75 mg filmsko obložene tablete CELSENTRI 150 mg filmsko obložene tablete CELSENTRI 300 mg filmsko obložene tablete
If uncertainty still exists, contact a pharmacist for advice.
Če ste še vedno negotovi, se posvetujte s farmacevtom.
The C max (CV%) was 335.6 ng/mL (87%) in healthy volunteers (normal renal function); 801.2 ng/mL (56%) in severe renal impairment; 576.7 ng/mL (51%) in ESRD (dosing after dialysis) and 478.5 ng/mL (38%) in ESRD (dosing before dialysis).
Cmax (KV %) je bila pri zdravih prostovoljcih (normalno delovanje ledvic) 335,6 ng/ml (87 %), pri bolnikih s hudo okvaro ledvic 801,2 ng/ml (56 %), pri bolnikih s končno odpovedjo ledvic (uporaba po dializi) 576,7 ng/ml (51 %) in s končno odpovedjo ledvic (uporaba pred dializo) 478,5 ng/ml (38 %).
The viral tropism cannot be predicted by treatment history or assessment of stored samples.
Tropizma virusa ni mogoče predvideti na podlagi anamneze o terapiji ali na podlagi shranjenih vzorcev.
Not studied, but these are potent CYP3A4 inducers and would be expected to decrease maraviroc concentrations.
Ni raziskano, vendar so močni induktorji CYP3A4, zato je mogoče pričakovati znižanje koncentracije maraviroka.
Maraviroc is not recommended to be used in treatment-naïve patients based on the results of a clinical study in this population (see section 5.1).
Na osnovi izsledkov klinične študije pri bolnikih, ki še niso bili zdravljeni, maraviroka pri tej populaciji ni priporočeno uporabljati (glejte poglavje 5.1).
Write the date the oral solution should be discarded on the carton in the space provided.
Datum, ko morate peroralno raztopino zavreči, vpišite v predvideni prostor na škatli.
In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates (<50 copies/mL at week 48) in patients with only CCR5tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
V retrospektivni analizi študij MOTIVATE z občutljivejšim preskusom presejalnega testa tropizma (Trofile ES), je bil delež odziva 48,2 % pri bolnikih ( < 50 kopij/ml po 48 tednih), pri katerih so ob začetku raziskave ugotovili samo CCR5-tropni virus in so jih zdravili z maravirokom + OOT (n=328), pri bolnikih, ki so prejemali placebo + OOT (n=178), pa je bil delež odziva 16,3%.
Etravirine and darunavir/ritonavir (maraviroc 150 mg BID)
Etravirin in darunavir/ritonavir (maravirok 150 mg dvakrat na dan)
Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations.
Sočasna uporaba maraviroka z zdravili, ki zavirajo CYP3A4, lahko poveča koncentracijo maraviroka v plazmi.
Paediatric patients (children younger than 2 years of age or weighing less than 10 kg) The safety and efficacy of CELSENTRI in children younger than 2 years of age or weighing less than 10 kg has not been established (see section 5.2).
Varnost in učinkovitost zdravila CELSENTRI pri otrocih, mlajših od 2 let oziroma s telesno maso manj kot 10 kg, še nista bili dokazani (glejte poglavje 5.2).
CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
CELSENTRI 25 mg filmsko obložene tablete CELSENTRI 75 mg filmsko obložene tablete CELSENTRI 150 mg filmsko obložene tablete CELSENTRI 300 mg filmsko obložene tablete maravirok
The average concentration (Cavg) of maraviroc over 24 hours was 445.1 ng/mL, 338.3 ng/mL, and 223.7 ng/mL for subjects with normal renal function, mild renal impairment, and moderate renal impairment, respectively.
Povprečna 24-urna koncentracija (Cpovp) maraviroka je bila pri osebah z normalnim delovanjem ledvic 445,1 ng/ml, pri bolnikih z blago okvaro ledvic 338,3 ng/ml in z zmerno okvaro ledvic 223,7 ng/ml.
Concomitant use of maraviroc and St. John's Wort or products containing St. John's Wort is not recommended.
Sočasna uporaba maraviroka in šentjanževke ali pripravkov, ki vsebujejo šentjanževko, ni priporočljiva.
Maraviroc has no antiviral activity in vitro against viruses which can use CXCR4 as their entry coreceptor (dual-tropic or CXCR4-tropic viruses, collectively termed ‘CXCR4-using' virus below).
Maravirok in vitro ne deluje proti virusom, ki lahko kot soreceptor za vstop uporabijo CXCR4 (duotropni ali CXCR4-tropni virusi; v nadaljevanju: "uporabniki CXCR4").
Maraviroc should only be used when only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) as determined by an adequately validated and sensitive detection method (see sections 4.1, 4.2 and 5.1).
Maravirok naj bi uporabljali le, če je z ustrezno validirano in občutljivo metodo (glejte poglavja 4.1, 4.2 in 5.1) ugotovljen CCR5-tropni HIV-1 (tj. ni odkrit CXCR4- ali dualno/mešano-tropni virus).
The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
V ključnih študijah je bila incidenca okužb, značilnih za aids, podobna med kraki z maravirokom ter s placebom.
Geometric mean ratios for Cmax and AUClast were 11% and 25% higher respectively for subjects with mild hepatic impairment, and 32% and 46% higher respectively for subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
Pri preiskovancih z blago okvaro jeter je bilo razmerje geometrijskih sredin za Cmax 11 % večje in za AUClast 25 % večje, pri preiskovancih z zmerno okvaro jeter pa za Cmax 32 % večje in za AUClast 46 % večje kot pri preiskovancih z normalnim delovanjem jeter.
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
Plastenke iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, zaprte z aluminijsko folijo/polietilenom s toplotno indukcijo; plastenke vsebujejo 120 filmsko obloženih tablet.
ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID)
ANTIARITMIKI Digoksin 0,25 mg enkraten odmerek (maravirok 300 mg dvakrat na dan)
Multipack: 180 (2 packs of 90) film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA Dvojno pakiranje: 180 (2 pakiranji po 90) filmsko obloženih tablet
Always take or give this medicine exactly as your doctor has told you.
Pri jemanju ali dajanju tega zdravila natančno upoštevajte navodila zdravnika.
Hepatobiliary disorders reported in treatment-naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Bolezni jeter, žolčnika in žolčevodov, zabeležene pri še nezdravljenih bolnikih, so bile občasne in po terapevtskih skupinah uravnotežene (glejte poglavje 4.8).
Nelfinavir is a potent CYP3A4 inhibitor and would be expected to increase maraviroc concentrations.
Nelfinavir je močan zaviralec CYP3A4 in pričakovati je mogoče zvišanje koncentracije maraviroka.
Other medicines and CELSENTRI Tell your doctor or pharmacist if you (or your child) are taking, any other medicines, have recently taken, or might take any other medicines.
Obvestite zdravnika ali farmacevta, če vi (ali vaš otrok) jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
In treatment-naïve patients such events occurred at a similarly low rate with maraviroc and control (efavirenz).
Med še nezdravljenimi bolniki je bil delež takšnih dogodkov z maravirokom podobno majhen kot s primerjalnim zdravilom (efavirenz).
Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less than 10 kg.
Zato zdravilo CELSENTRI ni priporočljivo za otroke, mlajše od 2 let ali s telesno maso manj kot 10 kg.
The most frequently reported adverse reactions occurring in the Phase 2b/3 studies were nausea,
Najpogosteje opisani neželeni učinki v študijah faze 2b/3 so bili navzea, driska, utrujenost in glavobol.
The discard date of the oral solution should be written on the carton in the space provided.
Datum, ko je treba peroralno raztopino zavreči, zapišite v temu namenjeni prostor na škatli.
The clinical status of the patient and the adverse reaction profile of maraviroc should be borne in mind when considering the patient's ability to drive, cycle or operate machinery.
Pri razmisleku o bolnikovi sposobnosti vožnje, kolesarjenja ali upravljanja strojev je treba upoštevati bolnikovo klinično stanje in značilnosti neželenih učinkov maraviroka.
Uncommon side effects These may affect up to 1 in 100 people:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
• 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).
• zvišanje vrednosti jetrnih encimov (pokaže se na preiskavah krvi), ki je lahko znak težav z jetri
Cobicistat is a potent CYP3A inhibitor.
Kobicistat je močan zaviralec CYP3A.
The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg .
Uporaba zdravila CELSENTRI ni bila raziskana pri otrocih, mlajših od 2 let ali s telesno maso manj kot 10 kg.
Cases of hepatotoxicity and hepatic failure with allergic features have been reported in association with maraviroc.
V povezavi z maravirokom so bili opisani primeri hepatotoksičnosti in jetrne odpovedi z alergijskimi značilnostmi.
Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.
Kot posamezna zdravilna učinkovina je elvitegravir indiciran samo v kombinaciji z zaviralci proteaz, okrepljenimi z ritonavirjem.
Therefore, no dose adjustment is necessary in patients with renal impairment receiving maraviroc without a potent CYP3A4 inhibitor (see sections 4.2, 4.4 and 4.5).
Zato bolnikom z okvaro ledvic, ki dobivajo maravirok brez močnega zaviralca CYP3A4, odmerka ni treba prilagoditi (glejte poglavje 4.2, 4.4 in 4.5).
Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 mg film-coated tablets
Nalepka na zunanjem ovoju dvojnega pakiranja po 180 (2 škatli z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box-om - 300 mg filmsko obložene tablete
Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Jedro tablete: mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, natrijev karboksimetilškrob, magnezijev stearat.
These may affect 1 to 10 in 100 people:
Pogosti neželeni učinki (pojavijo se lahko pri 1 do 10 od 100 bolnikov):
High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Plastenke iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, zaprte z aluminijsko folijo/polietilenom s toplotno indukcijo; plastenke vsebujejo 180 filmsko obloženih tablet.
90 film-coated tablets.
90 filmsko obloženih tablet
Phenotypic resistance
Fenotipska odpornost
Examples of agents/regimens with such potent CYP3A4-inhibiting activity are:
Primeri zdravilnih učinkovin z močnim zaviralnim učinkom na CYP3A4:
Maraviroc 300 mg twice daily + OBT N =421*
Maravirok 300 mg dvakrat na dan + OOT n = 421*
Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Nalepka na zunanjem ovoju dvojnega pakiranja po 180 (2 škatli z 90 filmsko obloženimi tabletami), ki je ovito v prozorno folijo - vključno z blue box-om - 150 mg filmsko obložene tablete
At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10 copies per mL), mean CD4+ cell count was 551 cells/mm3 (range 1 to 1654 cells/mm3) and mean CD4+ % was 21% (range 0% to 42%).
Izhodiščno je bila povprečna HIV-1 RNA v plazmi 4,3 log10 kopij/ml (razpon: od 2,4 do 6,2 log10 kopij/ml), povprečno število celic CD4+ je bilo 551 celic/mm
In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
V študiji faze I pri zdravih preiskovancih so imeli črnci z genotipom CYP3A5, ki prinaša izdatno presnovo maraviroka (2 alela CYP3A5*1, n = 12), med uporabo 300 mg maraviroka dvakrat na dan 37 % oziroma 26 % manjšo AUC kot črnci (n = 11) in belci (n = 12) z genotipom CYP3A5, ki prinaša slabo presnovo maraviroka (brez alela CYP3A5*1).
Rare side effects These may affect up to 1 in 1,000 people:
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Pomožne snovi z znanim učinkom: ena 300 mg filmsko obložena tableta vsebuje 1,68 mg sojinega lecitina.
Fluconazole is considered to be a moderate CYP3A4 inhibitor.
Flukonazol velja za zmeren zaviralec CYP3A4.
>5.0x ULN
> 5,0 x ZNM 4,8
 stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving.
• bolečine (zlasti v kolku, kolenu ali rami),
Use the oral applicator supplied with the pack to measure your dose accurately.
Za točno odmerjanje odmerka uporabite aplikator za peroralno odmerjanje, ki je priložen v pakiranju.
Maraviroc 300 mg twice daily + OBT N=426
Maravirok 300 mg dvakrat na dan + OOT n = 426
If you notice any of these symptoms: Tell your doctor.
Če se vam pojavijo ti simptomi, nemudoma obvestite zdravnika.
These include:  symptoms of infections and inflammation  joint pain, stiffness and bone problems.
 simptomi okužb in vnetja,  bolečine v sklepih, togost sklepov in težave s kostmi.
Ketoconazole concentrations not measured, no effect is expected.
Koncentracija ketokonazola ni bila merjena, učinki niso pričakovani.
Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
Po posamičnem peroralnem odmerku 300 mg je maravirok glavna komponenta v obtoku (približno 42 % radioaktivnosti).
Hepatic disease
Bolezni jeter
Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec sojin lecitin indigotin (E132)
Dialysis had a minimal effect on exposure in subjects with ESRD.
Dializa je pri bolnikih s končno odpovedjo ledvic minimalno vplivala na izpostavljenost.
More patients treated with maraviroc discontinued due to lack of efficacy (43 vs.15) and among patients with lack of efficacy, the proportion acquiring NRTI resistance (mainly lamivudine) was higher in the maraviroc arm.
Med bolniki z nezadostno učinkovitostjo je bil delež s pridobljeno odpornostjo za nukleozidne zaviralce reverzne transkriptaze (predvsem za lamivudin) večji v kraku z maravirokom.
CELSENTRI should be used with caution in adult patients with severe renal impairment (CLcr <30 mL/min) who are receiving potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
Pri odraslih bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min), ki jemljejo močne zaviralce CYP3A4, je treba zdravilo CELSENTRI uporabljati previdno (glejte poglavji 4.4 in 5.2).
Anti-HCV Ribavirin
Zdravila proti hepatitisu C Ribavirin
CELSENTRI 300 mg film-coated tablets
CELSENTRI 300 mg filmsko obložene tablete
ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
ANTIBIOTIKI Sulfametoksazol/ trimetoprim 800 mg/160 mg dvakrat na dan (maravirok 300 mg dvakrat na dan)
CELSENTRI 75 mg film-coated tablets
CELSENTRI 75 mg filmsko obložene tablete
Nevirapine 200 mg BID (maraviroc 300 mg Single Dose)
Nevirapin 200 mg dvakrat na dan (maravirok 300 mg enkraten odmerek)
An increased risk of postural hypotension may occur in patients with severe renal insufficiency who are treated with potent CYP3A inhibitors or boosted protease inhibitors (PIs) and maraviroc.
Bolniki s hudo insuficienco ledvic, ki dobivajo močne zaviralce CYP3A ali okrepljene zaviralce proteaz in maravirok, imajo lahko večje tveganje posturalne hipotenzije.
Sulphamethoxazole/trimethoprim concentrations not measured, no effect expected.
Koncentraciji sulfametoksazola/trimetoprima nista bili merjeni, učinki niso pričakovani.
Not studied, but both are potent CYP3A4 inhibitors and would be expected to increase maraviroc concentrations.
Ni raziskano; ker pa sta oba močna zaviralca CYP3A4, je mogoče pričakovati zvišanje koncentracije maraviroka.
Each ml of oral solution contains 20 mg maraviroc.
En mililiter peroralne raztopine vsebuje 20 mg maraviroka.
Abdominal pain, flatulence, nausea common
Bolezni prebavil bolečine v trebuhu, flatulenca, navzea pogosti
celsentri 20 mg/ml
PODATKI V BRAILLOVI PISAVI celsentri 20 mg/ml
Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
Ugotovljeno je, da je odpornost predhodno neodkritih CXCR4-tropnih virusov iz manjšinske virusne populacije proti drugim skupinam protiretrovirusnih zdravil podobna kot odpornost CCR5-tropnih virusov.
Other developmental parameters of these offspring, including fertility and reproductive performance, were not affected by the maternal administration of maraviroc.
Uporaba maraviroka pri samicah materah ni vplivala na druge razvojne parametre tega potomstva, vključno s plodnostjo in spodobnostjo razmnoževanja.
• The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, strawberry flavouring (501440T), purified water
• Druge sestavine zdravila so: citronska kislina (brezvodna), natrijev citrat dihidrat, sukraloza,
CD4+ cell count Mean change from baseline (cells/µL) 1 p-values < 0.0001 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline, which was 97.5%
Intervali zaupanja so bili za vse primarne cilje učinkovitosti 95 %, za spremembo HIV-1 RNA od izhodišča pa 97,5 %.
CXCR4-using virus was detected at failure in approximately 60% of subjects who failed treatment on maraviroc, as compared to 6% of subjects who experienced treatment failure in the placebo + OBT arm. To investigate the likely origin of the on-treatment CXCR4-using virus, a detailed clonal analysis was conducted on virus from 20 representative subjects (16 subjects from the maraviroc arms and 4 subjects from the placebo + OBT arm) in whom CXCR4-using virus was detected at treatment failure.
Da bi raziskali verjetni izvir virusa uporabnika CXCR4 med zdravljenjem, so opravili podrobno klonsko analizo virusov 20 reprezentativnih preiskovancev (16 preiskovancev iz kraka z maravirokom in 4 preiskovancev iz kraka s placebom + OOT), pri katerih so ob neuspehu terapije ugotovili virus uporabnik CXCR4.
Postural hypotension (see section 4.4) uncommon
Žilne bolezni posturalna hipotenzija (glejte poglavje 4.4)
2x carton for blister pack containing 300 mg maraviroc film-coated tablets - without Blue Box
PODATKI NA ZUNANJI OVOJNINI 2× škatla za pretisne omote s 300 mg filmsko obloženimi tabletami - brez blue box
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Nenukleozidni zaviralci reverzne transkriptaze (NNRTI) Efavirenz 600 mg enkrat na dan (maravirok 100 mg dvakrat na dan)
Check with your doctor if you think this applies to you or your child.
Pred začetkom zdravljenja se posvetujte z zdravnikom, če mislite, da se kaj od naštetega nanaša na vas (ali na vašega otroka).
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
Zaviralci nukleozidne in nukleotidne reverzne transkriptaze (NRTI) Lamivudin 150 mg dvakrat na dan (maravirok 300 mg dvakrat na dan)
2x carton for blister pack containing 150 mg maraviroc film-coated tablets - without Blue Box
PODATKI NA ZUNANJI OVOJNINI 2× škatla za pretisne omote s 150 mg filmsko obloženimi tabletami - brez blue box
Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Bolezni mišično-skeletnega sistema in vezivnega tkiva miozitis, zvišanje kreatin-fosfokinaze v krvi občasni atrofija mišic redki
Therefore, unless your doctor tells you (or your child) to stop treatment, it is important to keep taking CELSENTRI correctly, as described above.
Zato je pomembno, da zdravilo CELSENTRI jemljete pravilno, tako kot je opisano zgoraj, razen če vam (ali vašemu otroku) zdravnik naroči, da morate zdravljenje prekiniti.
>2.0x ULN
> 2,0 x ZNM 4,9
Store the oral solution below 30°C.
Peroralno raztopino shranjujte pri temperaturi do 30 °C.
The highest dose administered in clinical studies was 1,200 mg.
Največji aplicirani odmerek v kliničnih študijah je bil 1.200 mg. Neželeni učinek, ki je omejeval odmerek, je bila posturalna hipotenzija.
Efavirenz 600 mg QD + saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Efavirenz 600 mg enkrat na dan + sakvinavir/ritonavir 1000 mg/100 mg dvakrat na dan (maravirok 100 mg dvakrat na dan)
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz and a PI (except tipranavir/ritonavir where the dose should be 600 mg twice daily).
Če je zdravilo CELSENTRI uporabljeno sočasno z efavirenzom in zaviralcem proteaz, je treba njegov odmerek zmanjšati na 150 mg dvakrat na dan (izjema je sočasna uporaba s tipranavirjem/ritonavirjem, kjer mora biti odmerek 600 mg dvakrat na dan).
CELSENTRI can make you dizzy.
Zdravilo CELSENTRI lahko povzroči omotico.
Discontinue maraviroc and other suspect agents immediately if signs or symptoms of severe skin or hypersensitivity reactions develop.
Če se pojavijo znaki ali simptomi hudih kožnih ali preobčutljivostnih reakcij, nemudoma nehajte uporabljati maravirok in druga sumljiva zdravila.
CELSENTRI 25 mg film-coated tablets
CELSENTRI 25 mg filmsko obložene tablete
Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”.
Modra, bikonveksna, ovalna filmsko obložena tableta, velika približno 8,56 mm x 15,5 mm z oznako "MVC 150".
Excipient with known effect: each 75 mg film-coated tablet contains 0.42 mg of soya lecithin.
Pomožne snovi z znanim učinkom: ena 75 mg filmsko obložena tableta vsebuje 0,42 mg sojinega lecitina.
CELSENTRI 150 mg film-coated tablets
CELSENTRI 150 mg filmsko obložene tablete
Dose adjustment is necessary in patients with renal impairment receiving maraviroc with potent CYP3A4 inhibitors (see sections 4.2 and 4.4 and 4.5).
Bolnikom z okvaro ledvic, ki dobivajo maravirok z močnimi zaviralci CYP3A4, je treba odmerek prilagoditi (glejte poglavje 4.2, 4.4 in 4.5).
Each film-coated tablet contains 300 mg of maraviroc.
Ena filmsko obložena tableta vsebuje 300 mg maraviroka.
How to store CELSENTRI Contents of the pack and other information
Vsebina pakiranja in dodatne informacije
Tenofovir concentrations not measured, no effect is expected.
Koncentracija tenofovirja ni bila merjena, učinki niso pričakovani.
SEDATIVES
Dojenje
Tipranavir/ritonavir 500 mg/200 mg BID (maraviroc 150 mg BID)
Tipranavir/ritonavir 500 mg/200 mg dvakrat na dan (maravirok 150 mg dvakrat na dan)
celsentri 300 mg
PODATKI V BRAILLOVI PISAVI celsentri 300 mg
At the time of failure with CXCR4-using virus, the resistance pattern to other antiretrovirals appears similar to that of the CCR5-tropic population at baseline, based on available data.
Na podlagi razpoložljivih podatkov kaže, da je ob neuspehu z virusom uporabnikom CXCR4 odpornost proti drugim protiretrovirusnim zdravilom podobna kot izhodiščno v CCR5-tropni populaciji.
Each film-coated tablet contains 75 mg of maraviroc.
Ena filmsko obložena tableta vsebuje 75 mg maraviroka.
GENERAL CLASSIFICATION FOR SUPPLY 15.
Shranjevanje zdravila CELSENTRI 6.