FrancophonIA/ELRC3.0 huggingface dataset:
English: There are limited data from the use of dolutegravir or rilpivirine in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni dolutegravira ili rilpivirina u trudnica.
English: Musculoskeletal and connective tissue disorders uncommon arthralgia myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva manje često artralgija mialgija
English: If a patient vomits more than 4 hours after taking Juluca, the patient does not need to take another dose of Juluca until the next regularly scheduled dose.
Croatian: Ako bolesnik povrati više od 4 sata nakon uzimanja lijeka Juluca, ne mora uzeti još jednu dozu do sljedeće doze prema uobičajenom rasporedu.
English: Significant decreases in rilpivirine plasma concentrations are expected.
Croatian: Očekuju se značajna smanjenja koncentracija rilpivirina u plazmi.
English: No recommendations for dose adjustments can be made for Juluca.
Croatian: Ne mogu se dati preporuke za prilagodbu doze lijeka Juluca.
English: CAR N=511 n (%)
Croatian: Dotadašnji kombinirani antiretrovirusni režim N=511 n (%)
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Croatian: ispitivale u zdravih odraslih osoba, maksimalna srednja vrijednost razlika QTcF intervala u određenoj vremenskoj točki (gornja granica intervala pouzdanosti od 95%) u odnosu na placebo nakon korekcije za početnu vrijednost iznosila je 10,7 (15,3) ms, odnosno 23,3 (28,4) ms.
English: Rifabutin, a medicine to treat some bacterial infections, can lower the amount of Juluca in your body and make it less effective.
Croatian: Rifabutin, lijek koji se koristi za liječenje nekih bakterijskih infekcija, može smanjiti količinu lijeka
English: In limited data from small numbers of women who received dolutegravir 50 mg once daily in combination with a background regimen, the total exposure (AUC) to dolutegravir was 37% lower during the 2nd trimester of pregnancy, and 29% lower during the 3rd trimester of pregnancy, compared with postpartum (612 weeks).
Croatian: 50 mg jedanput na dan u kombinaciji s osnovnim režimom, ukupna izloženost (AUC) dolutegraviru bila je 37% manja tijekom drugog tromjesečja trudnoće i 29% manja tijekom trećeg tromjesečja trudnoće nego nakon poroda (6 - 12 tjedana).
English: Rilpivirine ↔ AUC ↔
Croatian: rilpivirin ↔ AUC ↔
English: Therefore, use of Juluca during pregnancy is not recommended (see sections 4.6, 5.1 and 5.2).
Croatian: Stoga se primjena lijeka Juluca tijekom trudnoće ne preporučuje (vidjeti dijelove 4.6, 5.1 i
English: Juluca contains lactose.
Croatian: Juluca sadrži laktozu.
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (33 times the 50 mg human clinical exposure based on AUC).
Croatian: Dolutegravir nije utjecao na plodnost mužjaka ni ženki štakora pri dozama do 1000 mg/kg/dan, što je najveća ispitivana doza (izloženost 33 puta veća od kliničke izloženosti pri primjeni doze od 50 mg u ljudi, što je utvrđeno na temelju AUC-a).
English: 2 years.
Croatian: 6.3 Rok valjanosti 2 godine.
English: There was no teratogenicity with rilpivirine in rats and rabbits.
Croatian: Rilpivirin se nije pokazao teratogenim u štakora i kunića.
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to primary mutations (excluding at Q148) in experiments with site directed mutants, dolutegravir susceptibility remains at or near wildtype level.
Croatian: Kada se u pokusima na izolatima s ciljanom mutagenezom primarnim mutacijama (isključujući one na Q148) dodaju mutacije navedene kao sekundarne mutacije povezane s inhibitorima integraze (raltegravirom/elvitegravirom),
English: Contents of the pack and other information
Croatian: Kako čuvati lijek Juluca Sadržaj pakiranja i druge informacije
English: NAME OF THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets
Croatian: NAZIV LIJEKA Juluca 50 mg/25 mg filmom obložene tablete
English: Juluca is intended for use as a complete regimen for the treatment of HIV-1 infection and should not be administered with other antiretroviral medicinal products for the treatment of HIV.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Juluca je namijenjena za primjenu kao cjelovit režim za liječenje HIV-1 infekcije i ne smije se primjenjivati s drugim antiretrovirusnim lijekovima za liječenje HIV infekcije.
English: Metformin/ Rilpivirine1
Croatian: metformin / rilpivirin1
English: Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with ‘SV J3T' on one side.
Croatian: Ružičaste, ovalne, bikonveksne tablete, dimenzija približno 14 x 7 mm, s utisnutom oznakom
English: Co-administration of Juluca with medicinal products that induce CYP3A may result in decreased plasma concentrations of rilpivirine, which could reduce the therapeutic effect of Juluca (see Table 1).
Croatian: Istodobna primjena lijeka Juluca s lijekovima koji induciraju CYP3A može smanjiti koncentracije rilpivirina u plazmi, što može smanjiti terapijski učinak lijeka Juluca (vidjeti Tablicu 1).
English: - The other ingredients are mannitol (E421), magnesium stearate, microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, lactose monohydrate, croscarmellose sodium, povidone (K30), polysorbate 20, silicified microcrystalline cellulose, polyvinyl alcohol- part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), iron oxide red (E172).
Croatian: (K29/32), natrijev škroboglikolat, natrijev stearilfumarat, laktoza hidrat, umrežena karmelozanatrij, povidon (K30), polisorbat 20, silicificirana mikrokristalična celuloza, djelomično hidroliziran poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E172), crveni željezov oksid (E172).
English: Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take Juluca.
Croatian: Obavijestite svog liječnika ako imate ili ste imali tegoba s jetrom, uključujući hepatitis B i/ili C.
English: The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Croatian: Farmakokinetika rilpivirina nije se ispitivala u bolesnika s bubrežnom insuficijencijom.
English: Monitoring of liver function is recommended in patients with hepatitis B and/or C co-infection.
Croatian: U bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C preporučuje se praćenje jetrene funkcije.
English: Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Juluca being absorbed into your body and make it less effective.
Croatian: Nadomjesci kalcija, nadomjesci željeza ili multivitaminski pripravci mogu spriječiti apsorpciju lijeka Juluca u tijelo i tako umanjiti njegovu djelotvornost.
English: No dose adjustments are required when initiating co-administration of methadone with Juluca.
Croatian: Nije potrebno prilagođavati dozu kada se započinje istodobna primjena metadona i lijeka Juluca.
English: Juluca film-coated tablets are pink, oval, biconvex tablets debossed with ‘SV J3T' on one side.
Croatian: Juluca filmom obložene tablete su ružičaste, ovalne, bikonveksne tablete s utisnutom oznakom
English: 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).
Croatian: 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).
English: 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).
Croatian: 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]).
English: 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.
Croatian: 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.
English: Co-administration of Juluca with medicinal products that inhibit CYP3A may result in increased plasma concentrations of rilpivirine (see Table 1).
Croatian: Istodobna primjena lijeka Juluca s lijekovima koji inhibiraju CYP3A može povećati koncentracije rilpivirina u plazmi (vidjeti Tablicu 1).
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Croatian: Oštećenje bubrežne funkcije Bubrežni klirens djelatne tvari u nepromijenjenu obliku je sporedan put eliminacije dolutegravira.
English: Site-directed NNRTI mutant virus
Croatian: Virusni izolat s ciljanom mutagenezom rezistentan na NNRTI
English: Do not take these medicines during the 12 hours before you take Juluca, or for at least 4 hours after you take it.
Croatian: Ne smijete uzeti te lijekove unutar 12 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene.
English: 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.
Croatian: Y143R/H/C, E92Q i T66I) ne utječu na osjetljivost na dolutegravir in vitro.
English: Antacids should be taken well separated in time from the administration of Juluca (minimum 6 hours before or 4 hours after).
Croatian: Antacide treba uzeti sa značajnim vremenskim odmakom u odnosu na primjenu lijeka Juluca (najmanje 6 sati prije ili 4 sata nakon).
English: Tabulated summary of adverse reactions to Juluca based on clinical study and postmarketing experience with Juluca and its individual components
Croatian: 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
English: 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.
Croatian: 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.
English: 25-desacetyl-rifampicin
Croatian: 25-dezacetilrifampicin
English: The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Croatian: Najčešće primijećene aminokiselinske supstitucije koje su se pojavile uključivale su: L100I, K101E, V108I, E138K, V179F,
English: 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')
Croatian: 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')
English: Co-administration of Juluca with these metabolic inducers is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Juluca i tih metaboličkih induktora je kontraindicirana (vidjeti dio 4.3).
English: Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Juluca.
Croatian: Bolesnike treba upozoriti da su tijekom liječenja sastavnicama lijeka Juluca prijavljeni umor, omaglica i somnolencija.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija i 25 mg rilpivirina u obliku rilpivirinklorida.
English: • dabigatran etexilate, used to treat or prevent blood clots.
Croatian: • dabigatraneteksilat, koji se koristi za liječenje krvnih ugrušaka ili sprječavanje njihova nastanka
English: Rilpivirine ↔ (Not studied)
Croatian: rilpivirin ↔ (Interakcija se nije ispitivala)
English: Magnesium stearate Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate Lactose monohydrate Croscarmellose sodium Povidone (K30)
Croatian: Jezgra tablete manitol (E421) magnezijev stearat celuloza, mikrokristalična povidon (K29/32) natrijev škroboglikolat natrijev stearilfumarat laktoza hidrat karmelozanatrij, umrežena povidon (K30) polisorbat 20
English: 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.
Croatian: 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.
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Croatian: 4786 rekombinantnih kliničkih izolata HIV-1 rezistentnih na efavirenz i/ili nevirapin.
English: Resistance to rilpivirine was considered present when FC in EC50 value was above the biological cut-off (BCO) of the assay.
Croatian: Smatralo se da je rezistencija na rilpivirin prisutna kada je FC
English: 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.
Croatian: (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.
English: AUC ↑ 8% Cmin ↑ 10% Cmax ↑ 8%
Croatian: Cmin ↑ 10% Cmax ↑ 8%
English: Fluconazole Itraconazole Isavuconazole Posaconazole Voriconazole/ Dolutegravir
Croatian: flukonazol itrakonazol isavukonazol posakonazol vorikonazol / dolutegravir flukonazol itrakonazol isavukonazol posakonazol vorikonazol / rilpivirin dolutegravir ↔ (Interakcija se nije ispitivala)
English: 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.
Croatian: NNRTI-je, uključujući najčešće supstitucije K103N i Y181C, rilpivirin je pokazao antivirusnu aktivnost (FC ≤ biološke granične vrijednosti) protiv 64 (96%) soja.
English: 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')
Croatian: 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')
English: 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).
Croatian: 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,
English: Co-administration of Juluca with proton pump inhibitors is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Juluca i inhibitora protonske pumpe je kontraindicirana (vidjeti dio 4.3).
English: → Talk to your doctor for further advice on taking rifabutin with Juluca.
Croatian: → Za dodatne savjete o uzimanju rifabutina zajedno s lijekom Juluca, razgovarajte sa svojim liječnikom.
English: 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.
Croatian: 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,
English: 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).
Croatian: In vivo dolutegravir može povećati plazmatske koncentracije lijekova čije izlučivanje ovisi o OCT2 ili MATE-1 (npr. dofetilid,
English: Do not take an antacid during the 6 hours before you take Juluca, or for at least 4 hours after you take it.
Croatian: Ne smijete uzeti antacid unutar 6 sati prije uzimanja lijeka Juluca ni najmanje 4 sata nakon njegove primjene.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1282/001
English: Where possible, alternatives such as azithromycin should be considered.
Croatian: Kad je to moguće, treba razmotriti druge lijekove,
English: Methadone / Rilpivirine1
Croatian: metadon / rilpivirin1
English: Liver toxicity associated with liver enzyme induction was observed in rodents following rilpivirine administration.
Croatian: U glodavaca je nakon primjene rilpivirina primijećena toksičnost za jetru povezana s indukcijom jetrenih enzima.
English: AUC ↓ 76% Cmin NA Cmax ↓ 85%
Croatian: AUC ↓ 76% Cmin NP Cmax ↓ 85%
English: Co-administration of Juluca and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 1).
Croatian: Istodobna primjena lijeka Juluca i drugih lijekova koji inhibiraju spomenute enzime može povećati koncentracije dolutegravira u plazmi (vidjeti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1282/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1282/002
English: Digoxin/ Dolutegravir Digoxin/ Rilpivirine1
Croatian: digoksin / dolutegravir digoksin / rilpivirin1
English: (inhibition of CYP3A enzymes).
Croatian: (Inhibicija enzima iz obitelji CYP3A)
English: 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.
Croatian: 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.
English: AUC ↑ 13% Cmin NA Cmax ↑ 21%
Croatian: AUC ↑ 13% Cmin NP Cmax ↑ 21%
English: Cmax ↑ 66% Metformin
Croatian: Cmin NP Cmax ↑ 66%
English: (Not studied, inhibition of CYP3A enzymes).
Croatian: (Interakcija se nije ispitivala, inhibicija enzima iz obitelji CYP3A)
English: Dolutegravir1
Croatian: daklatazvir / dolutegravir1
English: Juluca should be prescribed by physicians experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Lijek Juluca moraju propisati liječnici s iskustvom u liječenju HIV infekcije.
English: 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).
Croatian: 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).
English: May cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Croatian: Može uzrokovati povećanje koncentracija rilpivirina u plazmi (inhibicija enzima iz obitelji CYP3A).
English: Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/ Rilpivirine
Croatian: antacidi (npr. aluminijev i magnezijev hidroksid i/ili kalcijev karbonat) / rilpivirin dolutegravir ↓ AUC ↓ 74%
English: 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).
Croatian: - dofetilidom - karbamazepinom, okskarbazepinom, fenobarbitalom, fenitoinom - rifampicinom, rifapentinom - inhibitorima protonske pumpe, kao što su omeprazol, esomeprazol, lanzoprazol, pantoprazol,
English: No dosage adjustment is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije
English: common decreased white blood cell count decreased haemoglobin decreased platelet count
Croatian: Poremećaji krvi i limfnog sustava često smanjen broj bijelih krvnih stanica smanjena vrijednost hemoglobina smanjen broj trombocita