natgillin/translations-raw huggingface dataset:
Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.56 times the 50 mg human clinical exposure based on AUC).
Peroralna primjena dolutegravira u skotnih ženki kunića u dozama do 1000 mg/kg na dan od 6. do 18. dana gestacije nije uzrokovala razvojnu toksičnost ni teratogenost (izloženost 0,56 puta veća od kliničke izloženosti pri primjeni doze od 50 mg u ljudi, što je utvrđeno na temelju AUC-a).
The primary efficacy endpoint for the SWORD studies was the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 (Snapshot algorithm for the ITTE population).
Primarna mjera ishoda za djelotvornost u ispitivanjima SWORD bio je udio ispitanika kojima je plazmatska koncentracija HIV-1 RNK u 48. tjednu iznosila < 50 kopija/ml (algoritam za globalnu snimku distribuiranog sustava [engl. snapshot algorithm] za populaciju prethodno izloženih bolesnika predviđenih za liječenje [engl. intent-to-treat exposed, ITT-E]).
The adverse reactions considered at least possibly related to treatment with the components of Juluca from clinical studies and post-marketing experience are listed in Table 2 by body system, organ class and frequency.
Nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet, čija se povezanost sa sastavnicama lijeka Juluca smatra barem mogućom, navedene su u Tablici 2 prema organskim sustavima i učestalosti.
Co-administration of Juluca with medicinal products that inhibit CYP3A may result in increased plasma concentrations of rilpivirine (see Table 1).
Istodobna primjena lijeka Juluca s lijekovima koji inhibiraju CYP3A može povećati koncentracije rilpivirina u plazmi (vidjeti Tablicu 1).
Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Oštećenje bubrežne funkcije Bubrežni klirens djelatne tvari u nepromijenjenu obliku je sporedan put eliminacije dolutegravira.
Site-directed NNRTI mutant virus
Virusni izolat s ciljanom mutagenezom rezistentan na NNRTI
Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it.
Ne smijete uzeti te lijekove unutar 12 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene.
Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Y143R/H/C, E92Q i T66I) ne utječu na osjetljivost na dolutegravir in vitro.
Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Antacide treba uzeti sa značajnim vremenskim odmakom u odnosu na primjenu lijeka Juluca (najmanje 6 sati prije ili 4 sata nakon).
Tabulated summary of adverse reactions to Juluca based on clinical study and postmarketing experience with Juluca and its individual components
Tablica 2: Tablični sažetak nuspojava lijeka Juluca na temelju iskustva iz kliničkih ispitivanja lijeka Juluca i njegovih pojedinačnih sastavnica i nakon njihova stavljanja u promet Klasifikacija organskih sustava
Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
konzumiranje alkohola, jaku imunosupresiju, viši indeks tjelesne mase), slučajevi osteonekroze prijavljeni su u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika dugotrajno izloženih kombiniranoj antiretrovirusnoj terapiji.
25-desacetyl-rifampicin
25-dezacetilrifampicin
The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Najčešće primijećene aminokiselinske supstitucije koje su se pojavile uključivale su: L100I, K101E, V108I, E138K, V179F,
If you can't take these supplements at the same time as Juluca, do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Ako ih ne možete uzeti istodobno s lijekom Juluca, nemojte uzeti nadomjestak kalcija, nadomjestak željeza ili multivitaminski pripravak unutar 6 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene (pogledajte i dio 3. ‘Kako uzimati lijek Juluca')
Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Istodobna primjena lijeka Juluca i tih metaboličkih induktora je kontraindicirana (vidjeti dio 4.3).
Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Juluca.
Bolesnike treba upozoriti da su tijekom liječenja sastavnicama lijeka Juluca prijavljeni umor, omaglica i somnolencija.
If calcium supplements, iron supplements or multivitamins cannot be taken at the same time as Juluca, these supplements should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Ako se nadomjesci kalcija, nadomjesci željeza ili multivitaminski pripravci ne mogu uzeti istodobno s lijekom Juluca, treba ih uzeti sa značajnim vremenskim odmakom u odnosu na primjenu lijeka Juluca (najmanje 6 sati prije ili 4 sata nakon).
At baseline, in the pooled analysis, characteristics were similar between treatment arms with the median age of subjects of 43 years (28%, 50 years of age or older; 3%, 65 years of age or older), 22% female, 20% nonwhite and 77% were CDC Class A. Median CD+cell count was about 600 cells per mm3 with 11% having CD4+ cell count less than 350 cells per mm3.
Prema analizi objedinjenih podataka, početne značajke bile su slične u obje liječene skupine - medijan dobi ispitanika iznosio je 43 godine (28% bilo je u dobi od 50 ili više godina, a 3% u dobi od 65 ili više godina), 22% ispitanika bile su žene, 20% nisu bili bijelci, a 77% imalo je infekciju kategorije
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 25 mg rilpivirina u obliku rilpivirinklorida.
• dabigatran etexilate, used to treat or prevent blood clots.
• dabigatraneteksilat, koji se koristi za liječenje krvnih ugrušaka ili sprječavanje njihova nastanka
Rilpivirine ↔ (Not studied)
rilpivirin ↔ (Interakcija se nije ispitivala)
Magnesium stearate Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate Lactose monohydrate Croscarmellose sodium Povidone (K30)
Jezgra tablete manitol (E421) magnezijev stearat celuloza, mikrokristalična povidon (K29/32) natrijev škroboglikolat natrijev stearilfumarat laktoza hidrat karmelozanatrij, umrežena povidon (K30) polisorbat 20
The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
za zametak i plod u štakora i kunića bile su 15, odnosno 70 puta veće od izloženosti u ljudi pri primjeni preporučene doze od 25 mg jedanput na dan.
Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
4786 rekombinantnih kliničkih izolata HIV-1 rezistentnih na efavirenz i/ili nevirapin.
Resistance to rilpivirine was considered present when FC in EC50 value was above the biological cut-off (BCO) of the assay.
Smatralo se da je rezistencija na rilpivirin prisutna kada je FC
In a rilpivirine study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
(Child-Pugh stadij B) s 8 kontrolnih ispitanika, izloženost rilpivirinu nakon primjene višestrukih doza bila je 47% veća u bolesnika s blagim oštećenjem jetrene funkcije te 5% veća u bolesnika s umjerenim oštećenjem jetrene funkcije.
AUC ↑ 8% Cmin ↑ 10% Cmax ↑ 8%
Cmin ↑ 10% Cmax ↑ 8%
Fluconazole Itraconazole Isavuconazole Posaconazole Voriconazole/ Dolutegravir
flukonazol itrakonazol isavukonazol posakonazol vorikonazol / dolutegravir flukonazol itrakonazol isavukonazol posakonazol vorikonazol / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
In a panel of 67 HIV-1 recombinant laboratory strains with one amino acid substitution at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity (FC≤BCO) against 64 (96%) of these strains.
NNRTI-je, uključujući najčešće supstitucije K103N i Y181C, rilpivirin je pokazao antivirusnu aktivnost (FC ≤ biološke granične vrijednosti) protiv 64 (96%) soja.
Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Ne smijete uzeti te lijekove unutar 12 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene (pogledajte i dio 3. ‘Kako uzimati lijek Juluca')
The efficacy and safety of switching from an antiretroviral regimen (containing 2 NRTIs plus either an INI, an NNRTI, or a PI) to a dual regimen of dolutegravir 50 mg and rilpivirine 25 mg was evaluated in 2 identical 48-week, randomised, open-label, multicentre, parallel-group, non-inferiority studies SWORD-1 (201636) and SWORD-2 (201637).
Djelotvornost i sigurnost prelaska s antiretrovirusnog režima (koji sadrži 2 NRTI-ja plus inhibitor integraze, NNRTI ili inhibitor proteaze) na dvojni režim koji uključuje dolutegravir u dozi od 50 mg i rilpivirin u dozi od 25 mg ocjenjivale su se u 2 identična 48-tjedna randomizirana, otvorena,
Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Istodobna primjena lijeka Juluca i inhibitora protonske pumpe je kontraindicirana (vidjeti dio 4.3).
→ Talk to your doctor for further advice on taking rifabutin with Juluca.
→ Za dodatne savjete o uzimanju rifabutina zajedno s lijekom Juluca, razgovarajte sa svojim liječnikom.
In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
U analizi provedenoj u 48. tjednu, 31 od 62 bolesnika liječena rilpivirinom koja su doživjela virološki neuspjeh istodobno je imao mutacije povezane s rezistencijom na NNRTI-je i NRTI-je; od tog 31 bolesnika,
In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 1 and sections 4.3 and 4.4).
In vivo dolutegravir može povećati plazmatske koncentracije lijekova čije izlučivanje ovisi o OCT2 ili MATE-1 (npr. dofetilid,
Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Ne smijete uzeti antacid unutar 6 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1282/001
Where possible, alternatives such as azithromycin should be considered.
Kad je to moguće, treba razmotriti druge lijekove,
Methadone / Rilpivirine1
metadon / rilpivirin1
Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration.
U glodavaca je nakon primjene rilpivirina primijećena toksičnost za jetru povezana s indukcijom jetrenih enzima.
AUC ↓ 76% Cmin NA Cmax ↓ 85%
AUC ↓ 76% Cmin NP Cmax ↓ 85%
Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Istodobna primjena lijeka Juluca i drugih lijekova koji inhibiraju spomenute enzime može povećati koncentracije dolutegravira u plazmi (vidjeti
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1282/002
Digoxin/ Dolutegravir Digoxin/ Rilpivirine1
digoksin / dolutegravir digoksin / rilpivirin1
(inhibition of CYP3A enzymes).
(Inhibicija enzima iz obitelji CYP3A)
R263K was reported from two individual patients with subtype B and subtype C in the Phase III clinical program for ART experienced, INI naive subjects, but without effects on dolutegravir susceptibility in vitro.
U kliničkom programu ispitivanja faze III, mutacija R263K prijavljena je u dva bolesnika s podtipovima B i C koji su prethodno primali antiretrovirotike, ali ne i inhibitore integraze, no ona nije utjecala na osjetljivost na dolutegravir in vitro.
AUC ↑ 13% Cmin NA Cmax ↑ 21%
AUC ↑ 13% Cmin NP Cmax ↑ 21%
Cmax ↑ 66% Metformin
Cmin NP Cmax ↑ 66%
(Not studied, inhibition of CYP3A enzymes).
(Interakcija se nije ispitivala, inhibicija enzima iz obitelji CYP3A)
Dolutegravir1
daklatazvir / dolutegravir1
Juluca should be prescribed by physicians experienced in the management of HIV infection.
4.2 Doziranje i način primjene Lijek Juluca moraju propisati liječnici s iskustvom u liječenju HIV infekcije.
In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
29% odnosno 35% manja nego u razdoblju nakon poroda, dok je u trećem tromjesečju vrijednost Cmax, AUC24h i Cmin bila 20%, 31% odnosno 42% manja nego u razdoblju nakon poroda (vidjeti dijelove 4.2, 4.4 i 4.6).
May cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Može uzrokovati povećanje koncentracija rilpivirina u plazmi (inhibicija enzima iz obitelji CYP3A).
Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Rilpivirine
antacidi (npr. aluminijev i magnezijev hidroksid i/ili kalcijev karbonat) / rilpivirin dolutegravir ↓ AUC ↓ 74%
Co-administration with the following medicinal products: - dofetilide; - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; - rifampicin, rifapentine; - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment; - St John's wort (Hypericum perforatum).
- dofetilidom - karbamazepinom, okskarbazepinom, fenobarbitalom, fenitoinom - rifampicinom, rifapentinom - inhibitorima protonske pumpe, kao što su omeprazol, esomeprazol, lanzoprazol, pantoprazol,
No dosage adjustment is required in patients with mild or moderate renal impairment.
Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije
common decreased white blood cell count decreased haemoglobin decreased platelet count
Poremećaji krvi i limfnog sustava često smanjen broj bijelih krvnih stanica smanjena vrijednost hemoglobina smanjen broj trombocita
Co-administration of Juluca with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of Juluca.
Istodobna primjena lijeka Juluca s lijekovima koji povisuju želučanu pH vrijednost može smanjiti koncentracije rilpivirina u plazmi, što može smanjiti terapijski učinak lijeka Juluca.
AUC ↓ 14% Cmin NA Cmax ↓ 14%
AUC ↓ 14% Cmin NP Cmax ↓ 14%
Macrolide antibiotics Clarithromycin Erythromycin /Dolutegravir
Makrolidni antibiotici klaritromicin eritromicin / dolutegravir klaritromicin eritromicin / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
Skin and subcutaneous tissue disorders common rash pruritus
Poremećaji kože i potkožnog tkiva često osip pruritus
Iron oxide yellow (E172) Iron oxide red (E172)
Ovojnica tablete poli(vinilni alkohol) - djelomično hidroliziran titanijev dioksid (E171) makrogol talk željezov oksid, žuti (E172) željezov oksid, crveni (E172) 6.2 Inkompatibilnosti
In limited data from small numbers of women in study IMPAACT P1026 who received dolutegravir 50 mg once daily during the 2nd trimester of pregnancy, mean intra-individual values for total dolutegravir Cmax, AUC24h and C24h values were, respectively, 26%, 37% and 51% lower as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 25%, 29% and 34% lower as compared to postpartum (see sections 4.2, 4.4. and 4.6).
Prema ograničenim podacima prikupljenima u malog broja žena iz ispitivanja IMPAACT P1026 koje su primale dolutegravir u dozi od 50 mg jedanput na dan tijekom drugog tromjesečja trudnoće, srednja intraindividualna vrijednost Cmax, AUC24h i C24h ukupnog dolutegravira bila je 26%, 37% odnosno
Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it (see also section 3, ‘How to take Juluca')
Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Juluca ni najmanje 4 sata nakon njegove primjene (pogledajte i dio 3. ‘Kako uzimati lijek Juluca')
The clinical status of the patient and the adverse reaction profile of Juluca should be borne in mind when considering the patient's ability to drive or operate machinery.
Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, treba imati na umu kliničko stanje bolesnika i profil nuspojava lijeka Juluca.
Co-administration of Juluca with rifampicin is contraindicated (see section 4.3).
Istodobna primjena lijeka Juluca i rifampicina je kontraindicirana (vidjeti dio 4.3).
(induction of CYP3A enzymes).
(Indukcija enzima iz obitelji CYP3A)
The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age and weighing ≥40 kg) showed that dolutegravir 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg orally once daily.
≥ 40 kg) s HIV-1 infekcijom koji su prethodno bili liječeni antiretroviroticima pokazala je da peroralna primjena dolutegravira u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali dolutegravir u peroralnoj dozi od
when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
- deksametazon (kortikosteroid koji se koristi kod mnogih stanja kao što su upala i alergijske reakcije) kada se uzima kroz usta ili primjenjuje injekcijom, osim u slučaju liječenja samo jednom dozom - pripravke koji sadrže gospinu travu (Hypericum perforatum) (biljni lijek koji se koristi za liječenje depresije)
If calcium or iron supplements, or multivitamins cannot be taken at the same time as Juluca, these supplements are recommended to be administered 6 hours before or 4 hours after taking Juluca (see section
Ako se nadomjesci kalcija ili željeza ili multivitaminski pripravci ne mogu uzeti istodobno s lijekom Juluca, preporučuje se primijeniti ih 6 sati prije ili 4 sata nakon uzimanja lijeka
The single INI-resistance substitutions T66K, I151L, and S153Y conferred a greater than 2-fold decrease in dolutegravir susceptibility (range: 2.3fold to 3.6-fold from reference).
S153Y smanjile su osjetljivost na dolutegravir više od 2 puta (raspon od 2,3 puta do 3,6 puta u odnosu na referentnu vrijednost).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
KUTIJA (SAMO POJEDINAČNA PAKIRANJA)
The combination of Juluca and supplements should be used with particular caution.
Kombinaciju lijeka Juluca i dodataka prehrani treba primjenjivati uz osobit oprez.
AUC ↔ Cmin NA
AUC ↔ Cmin NP
Paracetamol / Rilpivirine1,2
paracetamol / dolutegravir paracetamol / rilpivirin1,2
The combination of Juluca and dabigatran etexilate should be used with caution.
Kombinaciju lijeka Juluca i dabigatraneteksilata treba primjenjivati uz oprez.
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and to prevent fits) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
- rifampicin, rifapentin (lijekovi za liječenje nekih bakterijskih infekcija, kao što je tuberkuloza) - omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (lijekovi za sprječavanje i liječenje želučanih vrijedova, žgaravice ili bolesti refluksa kiseline)
Antacids, to treat indigestion and heartburn, can stop Juluca being absorbed into your body and make it less effective.
Antacidi, lijekovi za probavne smetnje i žgaravicu, mogu spriječiti apsorpciju lijeka Juluca u tijelo i tako umanjiti njegovu djelotvornost.
Rilpivirine ↓
rilpivirin ↓
Rilpivirine ↔
rilpivirin ↔
Dolutegravir ↔ (Not studied)
dolutegravir ↔ (Interakcija se nije ispitivala)
This may result in
Ako je moguće,
Increased exposure of rilpivirine is expected (inhibition of CYP3A enzymes).
Očekuje se povećana izloženost rilpivirinu (inhibicija enzima iz obitelji CYP3A).
NNRTI resistance associated substitution K101K/E mixture with no decreased susceptibility to rilpivirine (FC=1.2) was observed in one subject with identified adherence issues that received dolutegravir plus rilpivirine.
U jednog ispitanika liječenog dolutegravirom plus rilpivirinom kod kojeg su utvrđeni problemi s pridržavanjem liječenja primijećena je miješana supstitucija K101K/E povezana s rezistencijom na NNRTI, bez smanjene osjetljivosti na rilpivirin (FC = 1,2).
The combination of Juluca and antacids should be used with particular caution.
Kombinaciju lijeka Juluca i antacida treba primjenjivati uz osobit oprez.
• calcium supplements, iron supplements and multivitamins must be taken at the same time as Juluca with a meal.
• nadomjeske kalcija, nadomjeske željeza i multivitaminske pripravke, koji se moraju uzimati istodobno s lijekom Juluca, uz obrok.
Vardenafil Tadalafil/ Dolutegravir
vardenafil tadalafil / dolutegravir vardenafil tadalafil / rilpivirin dolutegravir ↔
Antiviral active substances Tenofovir disoproxil / Dolutegravir1
Antivirusne djelatne tvari tenofovirdizoproksil / dolutegravir1
Antimycobacterials Rifampicin/ Dolutegravir1
Antimikobakterijski lijekovi rifampicin / dolutegravir1
A higher incidence of liver chemistry elevations (Grade 1) were observed in patients treated with dolutegravir and rilpivirine co-infected with hepatitis C compared to those who were not co-infected.
Među bolesnicima liječenima dolutegravirom i rilpivirinom koji su imali istodobnu infekciju virusom hepatitisa C primijećena je viša incidencija povišenih vrijednosti rezultata testova jetrene funkcije (1. stupnja) nego u onih koji nisu imali istodobnu infekciju virusom hepatitisa C.
Co-administration is likely to cause significant decreases in rilpivirine plasma concentrations (induction of CYP3A enzymes).
Istodobna primjena će vjerojatno dovesti do značajnih smanjenja koncentracija rilpivirina u plazmi (indukcija enzima iz obitelji CYP3A).
If you notice after 12 hours, then skip that dose and take the next doses as usual.
preskočite tu dozu i uzmite sljedeću prema uobičajenom rasporedu.
Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8%
Cmax ↑ 5% Cτ ↑ 8%
A risk for increases in dabigatran plasma concentrations cannot be excluded
Ne može se isključiti rizik od povećanja koncentracija dabigatrana u plazmi (inhibicija P-gp-a u crijevima).
Dolutegravir had a <10 FC against 94% of the 705 clinical isolates.
FC dolutegravira iznosio je < 10 u 94% od
Considering all of the available in vitro and in vivo data, the following amino acid substitutions, when present at baseline, are likely to affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I or M230L.
E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I ili M230L.