natgillin/translations-raw huggingface dataset:
EU/1/16/1112/001 30 film-coated tablets EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1112/001 30 filmom obloženih tableta EU/1/16/1112/002 90 (3 boce od 30) filmom obloženih tableta
This should be considered when assessing a patient's ability to drive or operate machinery.
To bi trebalo imati u vidu prilikom utvrđivanja bolesnikove sposobnosti upravljanja vozilima i rada sa strojevima.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Ne može se međutim isključiti da je izloženost farmakološki aktivnom, nevezanom rilpivirinu značajno povećana kod umjerenog oštećenja funkcije.
Each of these active substances works by interfering with an enzyme called ‘reverse transcriptase', which is essential for the HIV-1 virus to multiply.
Svaka od ovih djelatnih tvari djeluje tako što utječe na enzim koji se naziva „reverzna transkriptaza“, koji je nužan za umnažanje virusa HIV-1.
Odefsey contains lactose monohydrate.
Odefsey sadrži laktozu monohidrat.
3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
3 Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se postigle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
It is possible that in the future, long-term users of Odefsey may get kidney problems.
Moguće je da bi u budućnosti dugotrajni korisnici lijeka Odefsey mogli imati tegobe s bubrezima.
If you have both HIV infection and hepatitis B, it is especially important not to stop your Odefsey treatment without talking to your doctor first.
Ako imate i HIV-infekciju i hepatitis B, naročito je važno da se ne prestanete liječiti lijekom Odefsey, a da prije toga niste razgovarali s liječnikom.
The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Razlika u stopi novih viroloških neuspjeha iz analize perioda od 48. tjedna do 96. tjedna između skupina koje primaju rilpivirin i efavirenz nije bila statički značajna.
Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Analozi nukleoz(t)ida mogu utjecati na mitohondrijsku funkciju do različitog stupnja, što je najizrazitije kod stavudina, didanozina i zidovudina.
The decrease in the unbound free fraction of rilpivirine exposure (i.e., active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Smanjenje nevezane slobodne frakcije izloženosti rilpivirinu (tj. djelatne) tijekom trudnoće u usporedbi s poslijeporođajnim razdobljem, bilo je manje izraženo nego kod ukupne izloženosti rilpivirinu.
N/A 10.0 (19.6)
N/P 10,0 (19,6)
The European Medicines Agency has deferred the obligation to submit the results of studies with Odefsey in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Odefsey u jednoj ili više podskupina pedijatrijske populacije za liječenje infekcije HIV-1 u ljudi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
b Week 96 window was between Day 631 and 714 (inclusive).
b Okvir 96. tjedna bio je između 631. i 714. dana (uključivo).
It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Preporučuje se da ne dojite kako bi se izbjegla mogućnost prenošenja virusa majčinim mlijekom na dojenče.
Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Samo adolescenti za koje se smatra da će vjerojatno dobro prihvatiti antiretrovirusnu terapiju trebaju biti liječeni rilpivirinom jer prihvaćanje koje nije optimalno može dovesti do razvoja rezistencije i gubitka opcija za buduće liječenje.
In these 2 patients, no amino acid substitutions associated with resistance to any of the components of E/C/F/TAF were identified in HIV-1 or HBV.
U ta 2 bolesnika, supstitucije aminokiselina povezane s rezistencijom na bilo koji sastojak E/C/F/TAF-a nisu utvrđene u HIV-1 ili HBV.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Terapiju treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.
Talk to your doctor about an alternative regimen (see How to take Odefsey).
Obratite se svom liječniku u svezi sa zamjenskim režimom (vidi Kako uzimati lijek Odefsey).
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Rilpivirin inhibira P-glikoprotein (P-gp) in vitro (50% inhibitorna koncentracija [IC50] iznosi 9,2 µM).
• increased levels of liver enzymes in the blood
• povišene razine enzima jetre u krvi
AUCtau (ng•h/mL) 14,424.4 (23.9) 242.8 (57.8) 275.8 (18.4) 11,714.1 (16.6) 206.4 (71.8) 292.6 (27.4) Cmax (ng/mL)
TFVc AUCtau (ng•h/ml) 14 424,4 (23,9) 242,8 (57,8) 275,8 (18,4) 11 714,1 (16,6) 206,4 (71,8) 292,6 (27,4) Cmax (ng/ml) Ctau (ng/ml)
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, graviditet ili fetalne parametre.
Lipid disorders should be managed as clinically appropriate.
Poremećaje lipida potrebno je klinički prikladno liječiti.
• dexamethasone (oral and parenteral doses), except as a single dose treatment
• deksametazon (oralne i parenteralne doze), osim kao liječenje jednokratnom dozom
There is insufficient information on the effects of all the components of Odefsey in newborns/infants, therefore Odefsey should not be used during breast-feeding.
Nema dovoljno podataka o učincima svih komponenti lijeka Odefsey na novorođenčad/dojenčad, te se Odefsey stoga ne bi trebao koristiti tijekom dojenja.
The virologic response was generally preserved throughout the study: of the 12 patients that completed the study, 10 patients were suppressed at the end of the study; in the other 2 patients an increase in viral load was observed only postpartum, for at least 1 patient due to suspected suboptimal adherence.
Virološki odgovor bio je uglavnom očuvan tijekom trajanja ispitivanja: od 12 bolesnica koji su završile ispitivanje, 10 bolesnica bilo je suprimirano na kraju ispitivanja; u druge 2 bolesnice opažen je porast virusnog opterećenja samo u poslijeporođajnom razdoblju, a u najmanje 1 bolesnice zbog sumnje na neodgovarajuće pridržavanje terapije.
Interactions between Odefsey or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Interakcije između lijeka Odefsey ili njegovih pojedinih komponenti i istodobno primijenjenih lijekova navedene su u tablici 1 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔“), prikazanoj u nastavku.
• rifabutin, rifampicin, rifapentine
• rifabutin, rifampicin, rifapentin
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
• Dabigatran eteksilat, lijek koji se koristi za liječenje bolesti srca, jer će Vaš liječnik možda trebati kontrolirati razine ovog lijeka u Vašoj krvi.
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
• Metadon, lijek koji se koristi za liječenje ovisnosti od opijata, jer će vaš liječnik možda morati promijeniti vašu dozu metadona.
It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
Važno je da ne prestanete uzimati lijek Odefsey bez prethodnog razgovora sa svojim liječnikom: pogledajte dio 3, Nemojte prestati uzimati lijek Odefsey.
The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
Kombinacije emtricitabina, rilpivirina i tenofoviralafenamida nisu bile antagonistične i pokazale su međusobno sinergijske učinke u testovima antivirusne aktivnosti u kombinaciji staničnih kultura.
• If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
• Ako ste alergični na emtricitabin, tenofoviralafenamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen.
Mala poboljšanja BMD-a bila su opažena 48 tjedana nakon prebacivanja na E/C/F/TAF u usporedbi s ostankom na režimu koji sadrži tenofovirdizoproksilfumarat.
The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Sama supstitucija K103N nije rezultirala smanjenom osjetljivosti na rilpivirin, ali je kombinacija K103N i L100I rezultirala smanjenom osjetljivošću na rilpivirin za 7 puta.
Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
Znakovi osteonekroze su: ukočenost zglobova tupi bolovi i probadanje u zglobovima (osobito u kuku, koljenu i ramenu) poteškoće pri kretanju
Pooled treatment outcomes at 48 weeks are shown in Table 3.
Objedinjeni ishodi liječenja u 48 tjedana prikazani su u tablici 3.
Odefsey contains lactose
Odefsey sadrži laktozu
In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
Sigurnosni profil u adolescentnih bolesnika u ovom ispitivanju bio je sličan onome u odraslih (vidjeti dio 5.1).
EFV = efavirenz; RPV = rilpivirine a ITT TLOVR = Intention to treat time to loss of virologic response.
EFV = efavirenz; RPV = rilpivirin a ITT TLOVR = Vrijeme do gubitka virološkog odgovora u populaciji predviđenoj za liječenje.
At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Medijan eGFRCG na početku iznosio je 56 ml/min, a 33% bolesnika imalo je eGFRCG od 30 do 49 ml/min.
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
U stolici, nepromijenjeni rilpivirin je u prosjeku iznosio 25% primijenjene doze.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
U nekih bolesnika s uznapredovalom HIV-infekcijom (SIDA) i oportunističkim infekcijama u povijesti bolesti (infekcije koje nastaju u osoba sa slabim imunološkim sustavom) mogu se pojaviti znakovi i simptomi upale iz prethodnih infekcija ubrzo nakon početka liječenja HIV-a.
Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Rilpivirinklorid prvenstveno se metabolizira i eliminira kroz jetru.
• decrease in haemoglobin in your blood
• smanjenje hemoglobina u Vašoj krvi
What Odefsey is and what it is used for What you need to know before you take Odefsey How to take Odefsey
Što je Odefsey i za što se koristi Što morate znati prije nego počnete uzimati lijek Odefsey Kako uzimati lijek Odefsey
Table 1: Interactions between Odefsey or its individual component(s) and other medicinal products
Tablica 1: Interakcije između lijeka Odefsey ili pojedinih komponenti lijeka Odefsey i drugih lijekova
The adverse reactions in Table 2 are listed by system organ class and highest frequency observed.
Nuspojave u tablici 2 navedene su prema klasifikaciji organskih sustava i najveće uočene učestalosti.
Patients co-infected with HIV and HBV who discontinue Odefsey should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolesnike istodobno zaražene HIV-om i HBV-om koji prekinu liječenje lijekom Odefsey mora se pažljivo pratiti uz kliničku i laboratorijsku kontrolu tijekom najmanje nekoliko mjeseci nakon prekida liječenja.
Patients receiving Odefsey may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
U bolesnika koji primaju lijek Odefsey mogu se i dalje razvijati oportunističke infekcije i druge komplikacije infekcije HIV-om, pa bi stoga morali ostati pod strogim kliničkim nadzorom liječnika koji imaju iskustva u liječenju bolesnika s bolestima povezanim s HIV-om.
If you are on dialysis, take your daily dose of Odefsey following completion of dialysis.
Ako ste na dijalizi, uzmite svoju dnevnu dozu lijeka Odefsey nakon završetka postupka dijalize.
N/A 10.6 (28.5)
N/P 10,6 (28,5)
Mean values for the rilpivirine arm for both basal and ACTH-stimulated cortisol at Week 96 were within the normal range.
Srednje vrijednosti u skupini liječenoj rilpivirinom i za bazalni i za ACTH-om stimulirani kortizol u 96. tjednu bile su unutar normalnog raspona.
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Pošto je rilpivirin izrazito veže za proteine, dijaliza vjerojatno neće rezultirati značajnim uklanjanjem djelatne tvari.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
U slučaju predoziranja bolesnik mora biti pod nadzorom zbog moguće pojave znakova toksičnosti (vidjeti dio 4.8) i mora se prema potrebi primijeniti standardno potporno liječenje, uključujući praćenje kliničkog statusa bolesnika i nadzor vitalnih znakova i EKG-a (QT interval).
Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
Lijekovi koji utječu na aktivnost P-gp-a i BCRP-a mogu dovesti do promjena u apsorpciji tenofoviralafenamida (vidjeti tablicu 1).
a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
a Okvir 48. tjedna bio je između 294. i 377. dana (uključivo); okvir 144. tjedna bio je između 966. i 1049. dana (uključivo).
After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Nakon peroralne primjene jednokratne doze [14C]-rilpivirina, u prosjeku se 85% i 6,1% radioaktivnosti može izolirati u stolici, odnosno urinu.
Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Rijetko su zabilježeni neurološki poremećaji koji nastupaju kasnije (hipertonija, konvulzije, abnormalno ponašanje).
No Grade 3-4 laboratory abnormalities for AST/ALT or Grade 3-4 adverse reactions of transaminase increased were reported (see section 5.1).
Nisu zabilježene laboratorijske abnormalnosti stupnja 3-4 za AST/ALT niti nuspojave porasta transaminaza stupnja 3-4 (vidjeti dio 5.1).
 If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
 Ako opazite ove ili bilo kakve simptome upale ili infekcije, odmah o tome obavijestite vašeg liječnika.
• signs or symptoms of inflammation or infection
• znakovi ili simptomi upale ili infekcije
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
U mokraći su otkriveni samo tragovi nepromijenjenog rilpivirina (< 1% doze).
No human data on the effect of Odefsey on fertility are available.
Nisu dostupni podaci o učinku lijeka Odefsey na plodnost u ljudi.
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Biotransformacija emtricitabina uključuje oksidaciju tiolnog dijela molekule pri čemu nastaju 3'-sulfoksid diastereomeri (približno 9% doze), i konjugaciju s glukuronskom kiselinom, pri čemu nastaje 2'-O-glukuronid (približno 4% doze).
The pharmacokinetics of emtricitabine have not been studied in patients with varying degrees of hepatic insufficiency; however emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Farmakokinetika emtricitabina nije ispitana u bolesnika s različitim stupnjem insuficijencije jetre; međutim emtricitabin se neznatno metabolizira putem enzima jetre, pa bi učinak oštećenja funkcije jetre trebao biti ograničen.
Film-coating: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
Film ovojnica: makrogol, poli(vinilni alkohol), talk, titanijev dioksid (E171), željezov oksid, crni (E172)
The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Preporuka za doziranje vrijedi za preporučenu dozu rilpivirina od 25 mg jedanput na dan.
Inhibition of P-gp
Inhibicija P-gp
• severe skin reactions including rash accompanied by fever, swelling and liver problems
• teške reakcije na koži, uključujući osip praćen groznicom, oticanjem i tegobama s jetrom
Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Neki bolesnici koji uzimaju kombinirane antiretrovirusne lijekove kao što je Odefsey mogu razviti bolest kostiju koja se zove osteonekroza (odumiranje koštanog tkiva prouzrokovano gubitkom prokrvljenosti kosti).
depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1
depresija1, abnormalni snovi1,3, poremećaji spavanja1, depresivno raspoloženje1
Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Među tih 12 HIV-1 izolata, mutacije koje su se pojavile bile su M184V/I (n = 11) i K65R/N (n = 2) u RT i T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), i N155H (n = 2) u integrazi.
Emtricitabine did not inhibit in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Emtricitabin nije inhibirao in vitro metabolizam lijeka posredovan bilo kojom od glavnih izoformi ljudskog CYP-a koje su dio biotransformacije lijeka.
Through 144 weeks of treatment, no subject discontinued E/C/F/TAF due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
U 144 tjedna liječenja, nijedan ispitanik nije prekinuo primjenu E/C/F/TAF zbog štetnog događaja nastalog tijekom liječenja povezanog s funkcijom bubrega, u usporedbi s 12 ispitanika koji su prekinuli primjenu E/C/F/TDF (p < 0,001).
In the Phase 3 studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
U ispitivanjima faze 3 (C209 i C215), manja izloženost rilpivirinu slična onoj opaženoj tijekom trudnoće, povezana je s povećanim rizikom od virološkog neuspjeha pa je stoga potrebno pažljivo pratiti virusno opterećenje (vidjeti dijelove 4.6, 5.1 i 5.2).
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.9).
Budući da je rilpivirin u visokom postotku vezan za proteine plazme, nije vjerojatno da će se značajno ukloniti hemodijalizom ili peritonejskom dijalizom (vidjeti dio 4.9).
Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Nuspojave (svih stupnjeva) vrlo česte učestalosti su bile glavobolja, depresija, somnolencija i mučnina.
increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
povišen ukupni kolesterol (natašte)1, povišen LDL-kolesterol (natašte)1
Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum.
Rilpivirin (jedna od komponenti lijeka Odefsey) u kombinaciji s osnovnim režimom procijenjen je u ispitivanju TMC114HIV3015 provedenom u 19 trudnica tijekom 2. i 3. tromjesečja i poslije porođaja.
Induction of P-gp
Indukcija P-gp
H2-antagonists should not be taken twice a day.
H2-antagonisti se ne bi smjeli uzimati dvaput na dan.
When your supply of Odefsey starts to run low, get more from your doctor or pharmacist.
Kad Vam se smanji zaliha lijeka Odefsey, nabavite još lijeka od liječnika ili ljekarnika.
Odefsey regimen
Režim lijeka Odefsey
Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg.
Odefsey se koristi u odraslih i adolescenata u dobi od 12 godina i starijih, s tjelesnom težinom od najmanje 35 kg.
H2-antagonists should not be taken in a twice a day regimen.
H2-antagonisti se ne bi trebali uzimati u režimu dvaput na dan.
• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
• povišene razine kolesterola i/ili pankreasne amilaze (probavnog enzima) u krvi
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Tijekom HIV terapije može doći do povećanja težine i razine lipida i glukoze u krvi.
In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
In vitro eksperimenti ukazuju na to da rilpivirin hidroklorid primarno prolazi kroz oksidacijski metabolizam posredovan sustavom CYP3A.
The safety and efficacy of Odefsey in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Sigurnost i djelotvornost primjene lijeka Odefsey u bolesnika istodobno zaraženih virusom HIV-1 i virusom hepatitisa C (HCV) nisu ustanovljene.
There were no clinical signs or symptoms suggestive of adrenal or gonadal dysfunction in adults.
Nije bilo kliničkih znakova ili simptoma koji bi ukazivali na poremećaje nadbubrežne ili spolne žlijezde u odraslih.
If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Ako slučajno uzmete više od preporučene doze lijeka Odefsey, može Vam se povećati rizik od mogućih nuspojava ovog lijeka (pogledajte dio 4, Moguće nuspojave).
 If any of these applies to you, talk to your doctor before taking Odefsey.
Ako se bilo što od ovog odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete lijek Odefsey.
Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Objedinjeni ishodi liječenja u 48. i 144. tjednu prikazani su u tablici 3.
No dose adjustments are required.
Nisu potrebne prilagodbe doze.
• If you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsades de Pointes).
• Ako uzimate bilo kakve lijekove koji mogu uzrokovati nepravilne srčane otkucaje (torsades de pointes), opasne po život.
In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
U drugom ispitivanju, supstitucija Y188L rezultirala je smanjenom osjetljivošću na rilpivirin, i to za 9 puta kod kliničkih izolata i za 6 puta kod ciljane mutageneze.
The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Mutacije povezane s NRTI rezistencijom, koje su se razvile u 3 ili više izolata bolesnika, bile su: K65R, K70E, M184V/I i K219E.