natgillin/translations-raw huggingface dataset:
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Relevantni primjeri su retinitis izazvan citomegalovirusom, generalizirane i/ili žarišne mikobakterijske infekcije i pneumonija čiji je uzročnik Pneumocystis jirovecii.
Patients should be advised that Juluca does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Oportunističke infekcije Bolesnike treba upozoriti da lijek Juluca ne može izliječiti HIV infekciju, zbog čega se i dalje mogu javljati oportunističke infekcije i druge komplikacije povezane s HIV infekcijom.
The recommended dose of Juluca is one tablet once daily.
Preporučena doza lijeka Juluca je jedna tableta jedanput na dan.
Dosing recommendations for paediatric patients cannot be made due to insufficient data (see section 4.2).
Ne mogu se dati preporuke za doziranje u pedijatrijskih bolesnika jer nema dovoljno podataka (vidjeti dio 4.2).
Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
U uvjetima imunološke rekonstitucije prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti); međutim, prijavljeno vrijeme do pojave je različito, pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja.
Any beneficial effect on fracture rate was not studied.
Potencijalni korisni učinci na stopu prijeloma nisu se ispitivali.
• signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome).
• znakovi ili simptomi upale ili infekcije, primjerice vrućica, zimica, znojenje (sindrom imunološke reaktivacije)
In further selection experiments using clinical isolates of subtype B, mutation R263K was seen in all five isolates (after 20 weeks and onwards).
U daljnjim selekcijskim pokusima na kliničkim izolatima podtipa B, mutacija R263K primijećena je kod svih pet izolata (od 20. tjedna nadalje).
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Maksimalna koncentracija rilpivirina u plazmi nakon peroralne primjene obično se postiže unutar 4 - 5 sati.
Silicified microcrystalline cellulose
silicificirana mikrokristalična celuloza
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
Međutim, ne može se potpuno isključiti mogućnost da rilpivirin može povećati izloženost drugim lijekovima koje prenosi P-gp i koji su osjetljiviji na inhibiciju P-gp-a u crijevima, npr. dabigatraneteksilat.
• increase in triglycerides (a type of fat)
• povećanje vrijednosti triglicerida (jedne vrste masnoća)
Moderate and high fat meals increased the dolutegravir AUC(0-∞) by approximately 87% and Cmax by approximately 75%.
Obroci s umjerenim i visokim udjelom masnoća povećali su AUC(0-∞) dolutegravira za približno 87%, a Cmax za približno 75%.
The use of Juluca during pregnancy is not recommended.
Primjena lijeka Juluca tijekom trudnoće se ne preporučuje.
The Juluca tablet must be taken with a meal.
Juluca tableta mora se uzeti uz obrok.
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
U jednom kliničkom ispitivanju rilpivirin nije značajno utjecao na farmakokinetiku digoksina.
There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults.
Nije bilo novih nalaza povezanih sa sigurnošću koji bi odstupali od poznatog profila sigurnosti rilpivirina u odraslih bolesnika s HIV-1 infekcijom.
When Juluca was taken with a meal, the absorption of both dolutegravir and rilpivirine was increased.
Kada se Juluca uzela uz obrok, povećala se i apsorpcija dolutegravira i apsorpcija rilpivirina.
If you are taking any of the above, ask your doctor about alternatives.
Ako uzimate bilo koji od navedenih lijekova, pitajte svog liječnika o drugim mogućnostima liječenja.
In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
In vitro dolutegravir nije pokazao ni izravnu ni slabu inhibiciju (IC50 > 50 μM) enzima citokroma P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, uridindifosfat glukuronoziltransferaze (UGT)1A1 ili UGT2B7 ni prijenosnika P-gp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 ili MRP4.
- This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
- Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po jedinici doze, tj. zanemarive količine natrija.
Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Poremećaji metabolizma i prehrane vrlo često povišene vrijednosti ukupnog kolesterola (natašte) povišene vrijednosti LDL-kolesterola (natašte)
There is no specific treatment for an overdose of Juluca.
Nema specifičnog liječenja za predoziranje lijekom Juluca.
Delay in stopping treatment with Juluca after the onset of hypersensitivity may result in a life-threatening allergic reaction.
Odgađanje prekida liječenja lijekom Juluca nakon pojave preosjetljivosti može uzrokovati po život opasnu alergijsku reakciju.
Juluca must be taken with a meal to obtain optimal absorption of rilpivirine (see section 4.2).
Juluca se mora uzeti uz obrok kako bi se omogućila optimalna apsorpcija rilpivirina (vidjeti dio 4.2).
In serial passage with strain NL432-based site directed mutants at N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
U serijskoj pasaži s izolatima na bazi soja NL432 s ciljanom mutagenezom na N155H ili E92Q, nije primijećena daljnja selekcija rezistencije (FC od približno 1 ostao je nepromijenjen).
• liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
• zatajenje jetre (znakovi mogu uključivati žutu boju kože i bjeloočnica ili neobično tamnu mokraću) Nuspojave nepoznate učestalosti
Juluca must be taken with a meal.
Juluca se mora uzeti uz obrok.
These mutations have been selected in patients with pre-existing raltegravir resistance and who were then treated with dolutegravir (listed as secondary mutations for dolutegravir).
Te su mutacije izdvojene u bolesnika s već postojećom rezistencijom na raltegravir koji su zatim liječeni dolutegravirom (navodi se kao sekundarna mutacija za dolutegravir).
Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase inhibitor experienced or infected with integrase inhibitor resistant virus by transmission.
dva su imala jedinstvenu supstituciju R263K na integrazi uz maksimalan FC od 1,93, jedan je ispitanik imao polimorfnu supstituciju V151V/I na integrazi uz maksimalan FC od 0,92, a jedan je ispitanik imao otprije postojeće mutacije integraze te se pretpostavlja da je prethodno primao inhibitore integraze ili da je prijenosom bio zaražen virusom rezistentnim na inhibitore integraze.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
OBLIK I SADRŽAJ Višestruko pakiranje: 90 (3 pakiranja s 30) tableta
For dolutegravir, when using the laboratory strain HIV-1 IIIB during passage over 112 days, mutations selected appeared slowly, with substitutions at positions S153Y and F; these mutations were not selected in patients treated with dolutegravir in the clinical studies.
Kod primjene dolutegravira su se pri korištenju laboratorijskog soja HIV-1 IIIB za vrijeme pasaže tijekom 112 dana odabrane mutacije pojavljivale polako, sa supstitucijama na položajima S153Y i F; te mutacije nisu izdvojene u bolesnika koji su primali dolutegravir u kliničkim ispitivanjima.
Ketoconazole
ketokonazol
There are no data on the effects of dolutegravir or rilpivirine on human male or female fertility.
Nema podataka o učincima dolutegravira ili rilpivirina na plodnost muškaraca ili žena.
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
U fecesu je rilpivirin u nepromijenjenu obliku u prosjeku činio 25% primijenjene doze.
PHARMACEUTICAL FORM AND CONTENTS 30 tablets.
OBLIK I SADRŽAJ 30 tableta.
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolesnike treba uputiti da potraže liječničku pomoć ako osjete tupe bolove i probadanja u zglobovima, ukočenost zglobova ili teškoće pri kretanju.
• artemether/lumefantrine used to prevent you catching malaria
• artemeter/lumefantrin, koji se koriste za sprječavanje razvoja malarije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - COMPONENT OF MULTIPACK)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJE PAKIRANJE (BEZ PLAVOG OKVIRA - SASTAVNI DIO VIŠESTRUKOG PAKIRANJA)
You need to know about important signs and symptoms to look out for while you're taking Juluca.
Morate znati na koje važne znakove i simptome treba pripaziti tijekom liječenja lijekom Juluca.
Subjects were enrolled if they were on their first or second antiretroviral regimen with no history of virological failure, had no suspected or known resistance to any antiretroviral and had been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to screening.
Ispitanici su bili uključeni ako su primali svoj prvi ili drugi antiretrovirusni režim i ako prethodno nisu doživjeli virološki neuspjeh, nisu imali suspektnu ni poznatu rezistenciju ni na jedan antiretrovirotik te su imali stabilnu supresiju (HIV-1 RNK < 50 kopija/ml) tijekom najmanje 6 mjeseci prije probira.
• increase in the level of enzymes produced in the muscles (creatine phosphokinase).
• povišene vrijednosti enzima koji nastaju u mišićima (kreatin fosfokinaze)
The most frequently reported adverse reactions considered possibly or probably related to the combined administration of dolutegravir plus rilpivirine in 513 HIV-1 infected subjects in the Phase III clinical trials (see section 5.1), were diarrhoea (2%) and headache (2%).
Najčešće prijavljene nuspojave čija se povezanost s kombiniranom primjenom dolutegravira plus rilpivirina smatrala mogućom ili vjerojatnom, zabilježene u 513 ispitanika s HIV-1 infekcijom u kliničkim ispitivanjima faze III (vidjeti dio 5.1), bile su proljev (2%) i glavobolja (2%).
• decreased number of platelets, which are involved in blood clotting
• smanjen broj krvnih pločica (trombocita), koje sudjeluju u zgrušavanju krvi
2 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered drug.
Ovo ispitivanje interakcija provedeno je uz dozu rilpivirina veću od preporučene, kako bi se ocijenio maksimalan učinak na istodobno primijenjeni lijek.
Hepatobiliary disorders very common increased transaminases (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevations)
Poremećaji jetre i žuči vrlo često povišene vrijednosti transaminaza (povišene vrijednosti alanin aminotransferaze [ALT] i/ili aspartat aminotransferaze [AST])
Two subjects across the pooled SWORD-1 (201636) and SWORD-2 (201637) studies from each treatment arm experienced confirmed virologic failure leading to withdrawal at any time through Week 48.
Prema objedinjenim podacima iz ispitivanja SWORD-1 (201636) i SWORD-2 (201637), dva ispitanika iz svake liječene skupine doživjela su potvrđen virološki neuspjeh koji je doveo do povlačenja iz ispitivanja u bilo kojem trenutku tijekom 48 tjedana.
Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5).
Postoje odvojeni pripravci dolutegravira i rilpivirina za slučajeve kada je indiciran prekid primjene ili prilagodba doze jedne od djelatnih tvari (vidjeti dio 4.5).
In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Kako postaje snažniji, imunosni sustav u rijetkim slučajevima može napadati i zdravo tkivo (autoimuni poremećaji).
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in study C213 (33 to 93 kg), similar to what was observed in adults.
U ispitivanja C213 tjelesna težina nije utjecala na farmakokinetiku rilpivirina u pedijatrijskih ispitanika (33 - 93 kg), što je slično onome opaženome u odraslih.
Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Učinak dolutegravira i rilpivirina na farmakokinetiku drugih lijekova Na temelju in vivo i/ili in vitro podataka, ne očekuje se da će dolutegravir utjecati na farmakokinetiku lijekova koji su supstrati bilo kojeg od glavnih enzima ili prijenosnika, kao što su CYP3A4, CYP2C9 i P-gp (za više informacija vidjeti dio 5.2).
Thirty-two percent of the total oral dose is excreted in the urine, mainly represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Trideset i dva posto ukupne peroralne doze izlučuje se kroz mokraću, uglavnom u obliku eter glukuronida dolutegravira (18,9% ukupne doze), metabolita dobivenog N-dealkilacijom (3,6% ukupne doze) ili metabolita koji nastaje oksidacijom na benzilnom atomu ugljika (3,0% ukupne doze).
Clinical status including liver aminotransferases and bilirubin should be monitored.
uključujući jetrene aminotransferaze i bilirubin.
Juluca should not be taken with any other medicinal product containing dolutegravir or rilpivirine, except in case of co-administration with rifabutin (see section 4.5).
Juluca se ne smije uzimati ni s jednim drugim lijekom koji sadrži dolutegravir ili rilpivirin, osim u slučaju istodobne primjene s rifabutinom (vidjeti dio 4.5).
The primary endpoint and other outcomes (including outcomes by key baseline covariates) for the pooled SWORD-1 and SWORD-2 studies are shown in Table 3.
Objedinjeni podaci za primarnu mjeru ishoda i druge ishode (uključujući ishode prema ključnim kovarijatama s početka ispitivanja) iz ispitivanja SWORD-1 i SWORD-2 prikazani su u Tablici 3.
No relevant effects were seen with dolutegravir on the QTc interval, with doses exceeding the clinical dose by approximately three fold.
Nisu primijećeni značajni učinci dolutegravira na QTc interval pri primjeni doza približno trostruko većih od kliničke doze.
It is not known whether the ingredients of Juluca can pass into your breast milk.
Nije poznato mogu li sastojci lijeka Juluca prijeći u majčino mlijeko.
Selected established and theoretical interactions between dolutegravir, rilpivirine and co-administered medicinal products are listed in Table 1.
Odabrane potvrđene i teorijske interakcije između dolutegravira, rilpivirina i istodobno primijenjenih lijekova navedene su u Tablici 1.
Dolutegravir is also a substrate of UGT1A3, UGT1A9, cytochrome P450 (CYP)3A4, Pglycoprotein (P-gp), and breast cancer resistance protein (BCRP); therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 1).
Dolutegravir je i supstrat za UGT1A3, UGT1A9, citokrom P450 (CYP)3A4, P-glikoprotein (P-gp) i protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP); stoga lijekovi koji induciraju navedene enzime mogu smanjiti koncentracije dolutegravira u plazmi i tako oslabiti terapijski učinak dolutegravira (vidjeti Tablicu 1).
common decreased appetite increased triglycerides (fasted) Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood anxiety uncommon suicidal ideation or suicide attempt (particularly in patients with a pre-existing history of depression or psychiatric illness)
Psihijatrijski poremećaji vrlo često nesanica često neuobičajeni snovi depresija poremećaji spavanja depresivno raspoloženje anksioznost manje često suicidalne misli ili pokušaj suicida (osobito u bolesnika s depresijom ili psihijatrijskom bolešću u anamnezi)
Very common side effects that may show up in blood tests are:
Vrlo česte nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
In contrast, starting passage with mutants with mutation Q148H (FC 1), a variety of raltegravir associated secondary mutations accumulated with a consequent increase of FC to values >10.
Nasuprot tome, ako je pasaža započela s mutantima koji su imali mutaciju Q148H (FC 1), akumulirao se niz različitih sekundarnih mutacija povezanih s primjenom raltegravira, što je za posljedicu imalo porast FC-a na vrijednosti > 10.
Animal studies with dolutegravir or rilpivirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Ispitivanja dolutegravira ili rilpivirina na životinjama ne ukazuju na izravne ni neizravne štetne učinke u smislu reproduktivne toksičnosti (vidjeti dio 5.3).
(induction of CYP3A due to high rilpivirine dose in the study).
(Indukcija CYP3A zbog visoke doze rilpivirina u ispitivanju)
Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
Liječnici trebaju pogledati trenutne smjernice za liječenje HIV infekcije u bolesnika s istodobnom infekcijom virusom hepatitisa B.
Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1).
Juluca je indicirana za liječenje infekcije virusom humane imunodeficijencije tipa 1 (HIV-1) u odraslih osoba u kojih je stabilnim antiretrovirusnim režimom postignuta virološka supresija (HIV-1 RNK < 50 kopija/ml) u trajanju od najmanje šest mjeseci i koje u anamnezi nemaju virološki neuspjeh ni poznatu ili suspektnu rezistenciju na bilo koji nenukleozidni inhibitor reverzne transkriptaze ili inhibitor integraze (vidjeti dio 5.1).
If the patient misses a dose of Juluca, the patient should take Juluca with a meal as soon as possible, providing the next dose is not due within 12 hours.
Ako bolesnik propusti dozu lijeka Juluca, treba je uzeti uz obrok što je prije moguće, pod uvjetom da do sljedeće doze nije preostalo manje od 12 sati.
The frequency category of rare was estimated based on postmarketing reports.
Kategorija učestalosti ‘rijetko' procijenjena je na temelju prijava nakon stavljanja lijeka u promet.
Lower exposures of dolutegravir or rilpivirine were observed when taken once daily, in combination with a background regimen, during pregnancy.
Primijećena je manja izloženost dolutegraviru ili rilpivirinu kod primjene jedanput na dan tijekom trudnoće, u kombinaciji s osnovnim režimom.
Juluca contains dolutegravir and rilpivirine, therefore any interactions identified with these active substances are relevant to Juluca.
Juluca sadrži dolutegravir i rilpivirin, pa su sve interakcije utvrđene kod primjene tih djelatnih tvari relevantne i za lijek Juluca.
Pregnancy and postpartum
Trudnoća i razdoblje nakon poroda
Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Dolutegravir se nakon peroralne primjene brzo apsorbira, pri čemu je medijan Tmax 2 do 3 sata nakon primjene doze u obliku tablete.
The combination of Juluca and artemether/lumefantrine should be used with caution.
Kombinaciju lijeka Juluca i artemetera/lumefantrina treba primjenjivati uz oprez.
INFORMATION IN BRAILLE juluca
16. PODACI NA BRAILLEOVOM PISMU juluca
• medicines called H2 receptor antagonists (for example cimetidine, famotidine, nizatidine, ranitidine) to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
• lijekove koji se zovu antagonisti H2-receptora (npr. cimetidin, famotidin, nizatidin, ranitidin), a koriste se za liječenje želučanih ili crijevnih vrijedova ili ublažavanje žgaravice uzrokovane refluksom kiseline.
Animal studies indicate no clinically relevant effects on male or female fertility (see section 5.3).
Ispitivanja na životinjama nisu pokazala klinički značajne učinke na plodnost mužjaka ili ženki (vidjeti dio 5.3).
Rilpivirine ↔* EE ↔
rilpivirin ↔* EE ↔
1 The interaction between dolutegravir and/or rilpivirine and the medicinal product was evaluated in a clinical study.
Interakcija između dolutegravira i/ili rilpivirina i tih lijekova procjenjivala se u kliničkom ispitivanju.
The effect of severe hepatic impairment (Child-Pugh score C) on the pharmacokinetics of dolutegravir or rilpivirine has not been studied, therefore Juluca is not recommended in these patients.
Učinak teškog oštećenja jetrene funkcije (Child-Pugh stadij C) na farmakokinetiku dolutegravira ili rilpivirina nije se ispitivao, pa se primjena lijeka Juluca ne preporučuje u tih bolesnika.
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (clades A, B, C, D, F, G, H) primary isolates with IC50 values ranging from 0.07 to 1.01 nM and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM.
Rilpivirin je pokazao antivirusnu aktivnost i protiv široke palete primarnih izolata HIV-1 iz skupine M (podtipovi A, B, C, D, F, G, H), uz vrijednosti IC50 u rasponu od 0,07 do 1,01 nM, te primarnih izolata iz skupine O, uz vrijednosti EC50 u rasponu od 2,88 do 8,45 nM.
Systemic exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Sistemska izloženost rilpivirinu u načelu je bila manja u bolesnika s HIV-1 infekcijom nego u zdravih ispitanika.
Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs), and rilpivirine belongs to a group of anti-retroviral medicines called nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Dolutegravir pripada skupini antiretrovirusnih lijekova koji se nazivaju inhibitori integraze, a rilpivirin pripada skupini antiretrovirusnih lijekova koji se zovu nenukleozidni inhibitori reverzne transkriptaze (engl. non-nucleoside reverse transcriptase inhibitors, NNRTI).
Rilpivirine 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
Nije vjerojatno da će rilpivirin u dozi od 25 mg jedanput na dan imati klinički značajnog učinka na izloženost lijekovima koje metaboliziraju CYP enzimi.
The single amino acid substitutions associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Pojedinačne aminokiselinske supstitucije povezane s gubitkom osjetljivosti na rilpivirin bile su K101P, Y181I i Y181V.
In 100% human serum, the dolutegravir mean protein fold shift was 75 fold, resulting in protein adjusted IC90 of 0.064 µg/mL.
U 100%-tnom ljudskom serumu srednja vrijednost promjene ekspresije proteina kod primjene dolutegravira iznosila je 75 puta, što je za posljedicu imalo vrijednost IC90 prilagođenu za proteine od 0,064 µg/ml.
300 mg once daily (+ 25 mg once daily rilpivirine)
300 mg jedanput na dan (+ 25 mg rilpivirina jedanput na dan)
Effect of other medicinal products on the pharmacokinetics of dolutegravir and rilpivirine
Učinci drugih lijekova na farmakokinetiku dolutegravira i rilpivirina
• increase in bilirubin (a test of liver function) in your blood.
• povećanje vrijednosti bilirubina (kojim se određuje funkcija jetre) u krvi