natgillin/translations-raw huggingface dataset:
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.
Prije početka uzimanja lijeka CELSENTRI potrebno je potvrditi da je prisutan samo CCR5-tropni HIV-1 (tj. da nisu prisutni CXCR4 ili dvostruko/miješani tropni virusi), korištenjem primjereno validirane i osjetljive metode detekcije na svježe uzetom uzorku krvi.
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.
Geometrijske srednje vrijednosti Cmax i AUClast bile su 11%, odnosno 25% više kod ispitanika s blagim oštećenjem jetre te 32%, odnosno 46% više kod bolesnika s umjerenim oštećenjem jetre u usporedbi s ispitanicima koji su imali normalnu funkciju jetre.
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)
Tablica 4: Patološka odstupanja 3-4 stupnja (prema ACTG kriterijima) čija je incidencija bila 1%, a koja se odnose na maksimalna odstupanja od normalnih laboratorijskih vrijednosti bez obzira na početne vrijednosti u ispitivanjima MOTIVATE 1 i MOTIVATE 2 (skupna analiza, do 48 tjedana)
Cardiovascular safety
Sigurnost za kardiovaskularni sustav
• diarrhoea, feeling sick, stomach ache, wind (flatulence),
• proljev, mučnina, bol u trbuhu, vjetrovi (flatulencija)
Virologic escape from maraviroc can occur via 2 routes: the emergence of pre-existing virus which can use CXCR4 as its entry co-receptor (CXCR4-using virus) or the selection of virus that continues to use exclusively drug-bound CCR5 (CCR5-tropic virus).
Rezistencija virusa na maravirok može se razviti na dva načina: porastom broja kopija već postojećeg virusa koji može koristiti CXCR4 kao ko-receptor za ulaz (virus koji koristi CXCR4) ili selekcijom virusa koji i dalje koristi samo CCR5 receptor vezan za lijek (CCR5-tropni virus).
CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.
CELSENTRI 25 mg i 75 mg filmom obložene tablete dostupne su u bocama od 120 tableta.
People taking combination therapy for HIV may get other side effects.
U osoba koje uzimaju kombiniranu terapiju za HIV možda će se javiti neke druge nuspojave.
Table 5: Demographic and baseline characteristics of patients (pooled studies MOTIVATE 1 and MOTIVATE 2)
Tablica 5: Demografske značajke bolesnika i nalazi s početka ispitivanja (objedinjena ispitivanja MOTIVATE 1 i MOTIVATE 2)
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.
Klinička djelotvornost maraviroka (u kombinaciji s drugim antiretrovirusnim lijekovima) na razinu HIV RNA u plazmi i broj CD4+ stanica ispitivani su u dva pivotalna randomizirana, dvostruko slijepa, multicentrična ispitivanja (MOTIVATE 1 i MOTIVATE 2, n=1076), koja su se provodila kod bolesnika zaraženih CCR5-tropnim HIV-1 utvrđenim Monogram Trofile testom.
• The active ingredient in CELSENTRI is maraviroc.
• Djelatna tvar u lijeku CELSENTRI je maravirok.
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 ne pokazuje antivirusnu aktivnost in vitro protiv virusa koji mogu koristiti CXCR4 kao koreceptor ulaska (dvostruko-tropni ili CXCR4-tropni virusi, zajedničkim imenom nazvani „virusi koji koriste CXCR4“).
Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2)
Tablica 7: Udio bolesnika u pojedinim podskupinama u kojih je u 48. tjednu postignuto 50 kopija/ml (zajednički podaci ispitivanja MOTIVATE 1 i MOTIVATE 2)
>5.0x ULN
5,0 x GGN
Hence, in the selection of a treatment regimen, it should be assumed that viruses forming part of the previously undetected CXCR4 -using population (i.e. minor viral population) harbours the same resistance pattern as the CCR5-tropic population.
Stoga pri odabiru načina liječenja, treba pretpostaviti da na početku neotkrivena populacija virusa koja koristi CXCR4 (tj. minorna populacija virusa) ima isti način razvoja rezistencije kao CCR5-tropni virusi.
The pharmacokinetics of oral maraviroc are not dose proportional over the dose range.
Farmakokinetika peroralno primijenjenog maraviroka nije proporcionalna primijenjenim dozama unutar raspona doziranja.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva*
Hyperbilirubinaemia, gammaglutamyltransferase increased uncommon
Hiperbilirubinemija, porast gamaglutamiltransferaze manje često
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).
Profil nuspojava u pedijatrijskih bolesnika temelji se na 48-tjednim podacima o sigurnosti iz ispitivanja A4001031, u kojem su 103 prethodno liječena bolesnika u dobi od 2 do < 18 godina zaražena virusom HIV-1 primala maravirok dva puta na dan u kombinaciji s optimiziranom osnovnom terapijom.
Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low.
Prema in vitro i kliničkim podacima, maravirok ima slab potencijal da utječe na farmakokinetiku istodobno primijenjenih lijekova.
Based on the extent of inhibition by atazanavir/ritonavir or darunavir/ritonavir in the absence of efavirenz, an increased exposure is expected.
Temeljem stupnja inhibicije atazanavira/ritonavira ili darunavira/ritonavira u odsutnosti efavirenza, očekuje se povišenje koncentracije.
Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Tablica 1 Preporučen režim doziranja za djecu u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg
Renal clearance accounts for approximately 23% of total clearance of maraviroc when maraviroc is administered without CYP3A4 inhibitors.
Renalni klirens maraviroka iznosi približno 23% od ukupnog klirensa maraviroka u slučaju kad nema istodobne primjene CYP3A4 inhibitora.
In adult patients with a creatinine clearance of <80 mL/min, who are also receiving potent CYP3A4 inhibitors, the dose interval of maraviroc should be adjusted to 150 mg once daily (see sections 4.4 and 4.5).
U odraslih bolesnika s klirensom kreatinina < 80 ml/min koji istodobno primaju snažne inhibitore CYP3A4, interval doziranja maraviroka treba prilagoditi na 150 mg jedanput na dan (vidjeti dijelove 4.4 i 4.5).
How to store CELSENTRI
Kako čuvati CELSENTRI
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 u izloženosti maraviroku između opsežnih i slabih metabolizatora CYP3A5 bila je manja kada se maravirok primjenjivao zajedno sa snažnim inhibitorom CYP3A: opsežni metabolizatori CYP3A5 (n=12) imali su 17% niži AUC maraviroka nego slabi metabolizatori CYP3A5 (n=11) kod primjene maraviroka u dozi od 150 mg jedanput na dan u prisutnosti darunavira/kobicistata (800/150 mg).
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.
Kod bolesnika inficiranih HIV-om s teškom imunodeficijencijom tijekom početka kombinirane antiretrovirusne terapije (CART) može se javiti upalni odgovor na asimptomatske i zaostale oportunističke infekcije.
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.
Kod odraslih zdravih ispitanika uzimanje tablete od 300 mg istodobno s doručkom s visokim sadržajem masnoća dovodi do smanjenja Cmax i AUC za 33%, dok primjena 75 mg oralne otopine istodobno s doručkom s visokim sadržajem masnoća smanjuje AUC maraviroka za 73%.
Limited data are available for coadministration with indinavir.
Podaci o istodobnoj primjeni s indinavirom su ograničeni.
 stiffness in the joints  aches and pains (especially in the hip, knee or shoulder)  difficulty moving.
• bolovi (posebice u kuku, koljenu ili ramenu)
Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects.
Istodobna primjena maraviroka s lijekovima koji induciraju CYP3A4 može sniziti koncentraciju maraviroka i umanjiti njegov terapijski učinak.
The pharmacokinetics in other races has not been evaluated.
Kod pripadnika ostalih rasa farmakokinetika nije ispitivana.
CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable (see sections 4.2 and 5.1).
CELSENTRI je u kombinaciji s drugim antiretrovirusnim lijekovima indiciran u liječenju prethodno liječenih odraslih osoba, adolescenata i djece u dobi od 2 ili više godina i tjelesne težine od najmanje 10 kg kod kojih je kao uzročnik bolesti utvrđen samo CCR5-tropni HIV-1 (vidjeti dijelove 4.2 i 5.1).
CELSENTRI 300 mg film-coated tablets EU/1/07/418/006 (180 tablets) EU/1/07/418/007 (30 tablets) EU/1/07/418/008 (60 tablets) EU/1/07/418/009 (90 tablets) EU/1/07/418/010 (2 x 90 tablets - multipack)
CELSENTRI 300 mg filmom obložene tablete EU/1/07/418/006 (180 tableta) EU/1/07/418/007 (30 tableta) EU/1/07/418/008 (60 tableta) EU/1/07/418/009 (90 tableta) EU/1/07/418/010 (2 x 90 tableta - višestruko pakiranje)
>2.0x ULN
2,0 x GGN
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
U uvjetima imunološke reaktivacije 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.
Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir
Etravirin i lopinavir/ritonavir, sakvinavir/ritonavir ili atazanavir/ritonavir
The effect of maraviroc on digoxin at the dose of 600 mg BID has not been studied.
Nije ispitivan učinak maraviroka na digoksin pri dozi od 600 mg 2x dnevno.
Co-administration of maraviroc with St. John's Wort is expected to substantially decrease maraviroc concentrations and may result in suboptimal levels and lead to loss of virologic response and possible resistance to maraviroc.
Istodobna primjena maraviroka i gospine trave mogla bi dovesti do značajnog sniženja koncentracija maraviroka, što bi moglo rezultirati subterapijskim koncentracijama i dovesti do gubitka osjetljivosti virusa i moguće rezistencije na maravirok.
CELSENTRI 150 mg film-coated tablets EU/1/07/418/001 (180 tablets) EU/1/07/418/002 (30 tablets) EU/1/07/418/003 (60 tablets) EU/1/07/418/004 (90 tablets) EU/1/07/418/005 (2 x 90 tablets - multipack)
CELSENTRI 150 mg filmom obložene tablete EU/1/07/418/001 (180 tableta) EU/1/07/418/002 (30 tableta) EU/1/07/418/003 (60 tableta) EU/1/07/418/004 (90 tableta) EU/1/07/418/005 (2 x 90 tableta - višestruko pakiranje)
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
Procjena nuspojava vezanih za uzimanje lijeka temelji se na skupnim podacima iz dvaju ispitivanja faze 2b/3 na prethodno liječenim odraslim bolesnicima (MOTIVATE 1 i MOTIVATE 2) te jednog ispitivanja na prethodno neliječenim bolesnicima (MERIT) zaraženima CCR5-tropnim virusom HIV-1 (vidjeti dijelove 4.4 i 5.1).
Efavirenz and atazanavir/ritonavir or darunavir/ritonavir
Efavirenz i atazanavir/ritonavir ili darunavir/ritonavir
Based on the extent of inhibition by lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir in the absence of etravirine, an increased exposure is expected.
Temeljem stupnja inhibicije od strane lopinavira/ritonavira, sakvinavira/ritonavira ili atazanavira/ritonavira u odsutnosti etravirina, očekuje se povišenje koncentracije.
Study A4001031 is an open-label, multicenter trial in paediatric patients (aged 2 years to less than 18 years) infected with CCR5-tropic HIV-1, determined by the enhanced-sensitivity Trofile assay.
Ispitivanje A4001031 bilo je otvoreno, multicentrično ispitivanje provedeno u pedijatrijskih bolesnika (u dobi od 2 do manje od 18 godina) zaraženih CCR5-tropnim virusom HIV-1, što je utvrđeno testom Trofile pojačane osjetljivosti.
When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.
Pri primjeni s drugim antiretrovirusnim lijekovima u kulturi stanica, kombinacija maraviroka s rasponom NRTI-a, NNRTI-a, IP-a ili s inhibitorom fuzije HIV-a enfuvirtidom nije pokazivala antagonistička svojstva.
CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
CELSENTRI 25 mg filmom obložene tablete EU/1/07/418/011
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.
Tablica 4 prikazuje patološka odstupanja 3-4 stupnja (prema ACTG kriterijima) s incidencijom 1%, koja se odnose na maksimalna odstupanja od normalnih laboratorijskih vrijednosti bez obzira na početne vrijednosti.
Darunavir/ritonavir concentrations were consistent with historical data.
Koncentracije darunavira/ritonavira bile su u skladu s podacima iz prethodnih ispitivanja.
Do not use CELSENTRI after the expiry date which is stated on the bottle and carton label.
CELSENTRI se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake EXP.
Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Maravirok pripada terapijskoj skupini antagonista CCR5.
Therefore, CELSENTRI should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Stoga CELSENTRI treba primjenjivati uz oprez u bolesnika s oštećenjem jetre (vidjeti dijelove 4.4 i 5.2).
The geometric mean AUCinf (CV%) for maraviroc was as follows: healthy volunteers (normal renal function) 1348.4 ng·h/mL (61%); severe renal impairment 4367.7 ng·h/mL (52%); ESRD (dosing after dialysis) 2677.4 ng·h/mL (40%); and ESRD (dosing before dialysis) 2805.5 ng·h/mL (45%).
Geometrijska srednja vrijednost AUCinf (CV%) za maravirok bila je kako slijedi: zdravi dobrovoljci (normalna bubrežna funkcija) 1348,4 ng·h/ml (61%); teško oštećenje bubrežne funkcije 4367,7 ng·h/ml (52%); ESRD (doziranje nakon dijalize) 2677,4 ng·h/ml (40%); te ESRD (doziranje prije dijalize) 2805,5 ng.h/ml (45%).
There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients.
Nema podataka o prebacivanju virološki suprimiranih bolesnika liječenih lijekom neke druge antiretrovirusne skupine na CELSENTRI.
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.
Prethodna rezistencija na ostale skupine antiretrovirusnih lijekova pokazala se sličnom kod prethodno neutvrđenog CXCR4 tropnog virusa iz manje virusne populacije, kao i kod CCR5 tropnog virusa.
The OBT was selected on the basis of the subject's prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
OBT je određen temeljem iskustava iz ranijeg liječenja bolesnika kao i određivanjem početne genotipske i fenotipske rezistencije virusa.
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.
U bolesnika s teškom bubrežnom insuficijencijom može doći do povećanog rizika posturalne hipotenzije ako se liječe snažnim inhibitorima izoenzima CYP3A ili inhibitorima proteaze (IP) pojačanog djelovanja i maravirokom.
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 koncentracija/odgovor kod virusa rezistentnih na maravirok fenotipski su određene izostankom 100%-tne inhibicije tijekom analiza serijskih razrjeđenja maraviroka (maksimalna postotna inhibicija [MPI] <100%).
Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
CELSENTRI se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, blisteru ili naljepnici boce iza oznake EXP.
• itraconazole, voriconazole, clarithromycin and telithromycin,
• itrakonazol, vorikonazol, klaritromicin i telitromicin
You (or your child) can still pass on HIV when taking this medicine, although the risk is lowered by effective treatment.
HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Boca od polietilena visoke gustoće (HDPE) sa sigurnosnim zatvaračem za djecu, koja sadrži 230 ml otopine maraviroka od 20 mg/ml.
Examples of agents/regimens with such potent CYP3A4-inhibiting activity are:
Primjeri lijekova/režima koji djeluju kao snažni inhibitori CYP3A4:
Close the bottle tightly with the cap, leaving the adaptor in place.
Čvrsto zatvorite bocu zatvaračem, a nastavak za bocu ostavite u grlu boce.
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 (CV%) bila je 335,6 ng/ml (87%) u zdravih dobrovoljaca (normalna bubrežna funkcija); 801,2 ng/ml (56%) za teško oštećenje bubrežne funkcije; 576,7 ng/ml (51%) za ESRD (doziranje nakon dijalize) te 478,5 ng/ml (38%) za ESRD (doziranje prije dijalize).
Not studied, no interaction expected.
Nije ispitivan, ne očekuju se interakcije.
Maraviroc Cmax: ↑ compared to historical controls Nevirapine concentrations not measured, no effect is expected.
Maravirok AUC12:  u usporedbi s ranije provedenim liječenjem Maravirok Cmax:  u usporedbi s ranije provedenim liječenjem Koncentracije nevirapina nisu određivane, učinak nije očekivan.
Percentage of patients with HIV-1 RNA <50 copies/mL
Postotak bolesnika s HIV-1 RNA  50 kopija/ml
CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
CELSENTRI 75 mg filmom obložene tablete EU/1/07/418/012
Medicinal product by therapeutic areas (dose of CELSENTRI used in study)
Lijekovi prema terapijskim područjima (doza lijeka
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).
U retrospektivnoj analizi ispitivanja MOTIVATE, u kojoj se koristio osjetljiviji test za probir na tropizam (Trofile ES), stopa odgovora (< 50 kopija/ml u 48. tjednu) bolesnika u kojih je na početku ispitivanja otkriven samo CCR5-tropni virus iznosila je 48,2% u bolesnika liječenih maravirokom i OBT-om (n=328) te 16,3% u onih liječenih kombinacijom placebo + OBT (n=178).
ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
Karbamazepin, fenobarbital, fenitoin
Medicines containing St. John's Wort (Hypericum perforatum) are likely to prevent CELSENTRI
Lijekovi koji sadrže gospinu travu (Hypericum perforatum) vjerojatno će onemogućiti pravilno djelovanje lijeka CELSENTRI.
If you are pregnant, if you become pregnant, or if you are planning to have a baby: Talk to your doctor about the risks and benefits of taking CELSENTRI.
Ako ste trudni, ako zatrudnite ili ako planirate imati dijete:
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 treba primjenjivati uz oprez i u bolesnika s teškom bubrežnom insuficijencijom te u bolesnika koji imaju faktore rizika za posturalnu hipotenziju ili posturalnu hipotenziju u anamnezi.
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).
CELSENTRI treba primjenjivati uz oprez u odraslih bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) koji uzimaju snažne inhibitore CYP3A4 (vidjeti dijelove 4.4 i 5.2).
If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
EXP {MM/YYYY}
ROK VALJANOSTI EXP {MM-GGGG}
Elvitegravir as a single agent is indicated only in combination with certain ritonavir boosted PIs.
Elvitegravir je u monoterapiji indiciran samo u kombinaciji s određenim inhibitorima proteaze pojačanima ritonavirom.
In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
In vitro ispitivanja su pokazala da je CYP3A4 ključni enzim u metaboliziranju maraviroka.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolesnike treba savjetovati da se obrate liječniku ako primijete pojavu stalnih tupih i povremeno jačih bolova u zglobovima, ukočenost zglobova ili otežanu pokretljivost zglobova.
Write the date the oral solution should be discarded on the carton in the space provided.
Upišite datum kada trebate baciti oralnu otopinu na za to predviđeno mjesto na kutiji.
Name and address of the manufacturer responsible for batch release Tablets
Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
Bile duct cancer, diffuse large B-cell lymphoma, Hodgkin's disease, metastases to bone, metastases to liver, metastases to peritoneum, nasopharyngeal cancer, oesophageal carcinoma rare
Karcinom žučnih vodova, difuzni limfom velikih B-stanica, Hodgkinova bolest, metastaze kostiju, metastaze jetre, peritonealne metastaze, nazofaringealni karcinom, ezofagealni karcinom rijetko